intraosseous access devices, systems and methods

专利摘要:
an intraosseous access system may include a lumen defining needle and a longitudinal axis about which the needle may be rotated during an insertion event. The needle may include a proximal end that remains on a patient's exterior during use, a distal end that may be inserted through the patient's skin in contact with a patient's bone, and a distal tip at a more distal end point. distal position of the needle that is positioned on the longitudinal axis of the needle. The system may further include a plug sized to be received within the needle lumen that may inhibit material from entering the needle when the system is inserted into the bone.
公开号:BR112019007804A2
申请号:R112019007804
申请日:2017-10-18
公开日:2019-09-17
发明作者:Muse Jay；Carter Patterson Ryan
申请人:Piper Access Llc；
IPC主号:

专利说明:

DEVICES, SYSTEMS AND METHODS OF INTRAOSSEAL ACCESS CROSS REFERENCE FOR RELATED APPLICATIONS [001] This application claims to benefit from US Provisional Patent Application No. 62 / 409,825, entitled DEVICES, SYSTEMS AND METHODS OF INTRA-ACCESS on October 18, deposited. 2016; US Provisional Patent Application No. 62 / 600,857, entitled PULP DE AGULHA CAPTURE MECHANISM, filed on March 7, 2017; and U.S. Provisional Patent Application No. 62 / 525,663, entitled SAFETY PROTECTIONS FOR STRETCHED INSTRUMENTS AND RELATED SYSTEMS AND METHODS, filed on June 27, 2017, all of which is incorporated by reference.
TECHNICAL FIELD [002] Certain modalities described here generally refer to devices, systems and methods for accessing the interior of a patient's bone, and other modalities relate more particularly to devices, systems and methods for obtaining intraosseous access, such as for intraosseous infusion.
BACKGROUND [003] Many devices, systems and methods have been developed to access a patient's bone interior, including for such purposes as intraosseous access. Known devices, systems and methods, however, suffer from one or more drawbacks that can be resolved, corrected, improved or avoided by certain modalities described herein.
BRIEF DESCRIPTION OF THE DRAWINGS [004] The present written disclosure describes
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2/82 illustrative modalities that are non-limiting and non-exhaustive. Reference is made to some of these illustrative modalities that are represented in the figures, in which:
[005] Figure 1 is an exploded view of a modality of an intraosseous access system, in which a subset of the system's access set is represented slightly enlarged and in elevation, and an automatic actuator component is represented in perspective;
[006] Figure 2 is a perspective view of an embodiment of a plug portion portion of the intraosseous access system of Figure 1;
[007] Figure 3 is an additional perspective view of the plug assembly;
[008] Figure 4 is a perspective view of an embodiment of a protection portion of the intraosseous access system of Figure 1;
[009] Figure 5 is a perspective view of an embodiment of a needle assembly portion of the intraosseous access system of Figure 1;
[0010] The figure 6 is View in transversal section of the setFigure 5; with needle to long of the line 6-6 vision [0011] The figure 7 is View in transversal section
enlarged from a distal end of a needle of the needle assembly;
[0012] Figures 8A-8E are cross-sectional views of the needle along lines of sight 8A-8A, 8B-8B, 8C-8C, 8D-8D and 8E-8E, respectively, in Figure 7;
[0013] Figure 9A is an enlarged plan view of the distal end of the needle;
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3/82 [0014] Figure 9B is a cross-sectional view of the needle along line of sight 9B-9B in Figure 7;
[0015] Figure 10 is an enlarged elevation view of the distal end of the needle;
[0016] Figure 11A illustrates an initial phase of an illustrative method of using the intraosseous access system of Figure 1, and is a cross-sectional view of a portion of the access set of the intraosseous access system in an assembled state, the access set including shutter set, guard, and needle set;
[0017] Figure 11 B represents another stage of the illustrative method and is a plan view of a distal end of an access set during drilling in a patient's bone;
[0018] Figure 11 C represents another stage of the illustrative method and is a cross-sectional view of the access set after it has been used to provide access to an interior of the patient's bone;
[0019] Figure 11 D represents another stage of the illustrative method and is an enlarged cross-sectional view of a portion of the access set, with a portion of the shutter hub not being shown for clarity purposes, in which the set of plug is shown to be uncoupled and removed from the needle assembly while the guard is in an unlocked state in relation to a plug, and is in a coupled state in relation to a needle hub;
[0020] Figure 11 E represents another stage of the illustrative method and is another cross-sectional view
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4/82 enlarged of the access set, in which the obturator set has been completely removed from the needle set and the protection is in the locked state in relation to the obturator to avoid inadvertent contact with a distal end of the obturator;
[0021] Figure 12A is an elevation view of an embodiment of a manual actuator that is compatible with at least a portion of the intraosseous access system represented in Figure 1;
[0022] Figure 12B is a perspective view of the manual actuator;
[0023] Figure 13 is an elevation view of another modality of an intraosseous access system that includes another modality of a manual actuator;
[0024] Figure 14 is an elevation view of yet another modality of an intraosseous access system that includes yet another modality of a manual actuator;
[0025] Figure 15A represents a stage of an illustrative method of forming a needle, which can generally be part of an illustrative method of forming an interosseous access system, and is an elevation view of a modality of a tube that has been straightened;
[0026] Figure 15B represents another stage of the illustrative method in which a distal end of the tube has been bent;
[0027] Figure 15C represents another stage of the illustrative method in which a simple application of pressure was applied to the distal end of the tube;
[0028] Figure 15D is a cross-sectional view of the tube, taken along line of sight 15D
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15D in Figure 15C, which represents an oval profile of the tube in a region of the tube that has been bent;
[0029] Figure 15E is a cross-sectional view of the tube as shown in Figure 15D, which represents another stage of the illustrative method in which compressive forces are applied to the tube along an elongation axis (for example , along a main axis of the tube's oval profile) and towards a longitudinal axis of the tube;
[0030] Figure 15F is a cross-sectional view of the tube, as shown in Figure 15D, which represents another phase of the illustrative method, in which the compressive force has been removed from the tube, thus allowing the tube to move naturally outward , or recover, to a more circular configuration; and [0031] Figure 16 is a cross-sectional view of an embodiment of a fixation that can be used in certain methods of forming or molding a distal end of a needle compatible with the various intraosseous access systems described herein.
DETAILED DESCRIPTION [0032] The present disclosure generally relates to bone penetration devices, systems and methods. In particular, certain embodiments disclosed herein may be used to pierce or otherwise be inserted or penetrate hard and compact bone tissue (cortical bone) to gain access to soft bone tissue (cancellous bone) or bone marrow. For example, certain modalities are particularly well suited for use in intraosseous access procedures, at least by
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6/82 reasons discussed here and / or for reasons that are otherwise evident from the present disclosure.
[0033] For purposes of illustration, much of the disclosure refers to the creation of a duct or communication passage into an interior of a bone structure through drilling or otherwise penetrating hard and compact bone tissue to gain access to the bone marrow or to the spongy bone. Once access to an internal region of a bone has been achieved, any variety of suitable procedures can be performed, such as, for example, bone marrow infusion, aspiration or extraction. Numerous situations can benefit from providing access to a bone interior in ways as disclosed here, such as when other methods of accessing an IV needle vein are difficult or in emergency situations, such as heart attack, burns , drug overdoses, etc., when quick access to a patient's vasculature through the inside of a bone may be desired. Other illustrative, non-limiting examples include bone marrow biopsy or bone marrow aspiration. The present disclosure is not, however, limited to these specific applications.
[0034] Certain known systems and methods for providing access to the inside of the bone depend on a penetrator assembly that includes an external penetrator and an internal trocar operable by a drill to penetrate the compact bone to gain access to the bone marrow. To initially make contact with the hard bone, it is often necessary to penetrate the skin and tissue that covers the bone. The previous methods use a sharp internal trocar to
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7/82 perforate, puncture or otherwise advance through the fabric. However, although the sharp tip of the trocar may be adequate to provide a passage through the tissue, it can be suboptimal to initiate the cutting action through hard bone. In some cases, the sharp tip actually rotates on the surface of the hard bone until the cutting edges of the trocar can be engaged with the hard bone.
[0035] Certain modalities disclosed here can be advantageous over at least the previous approaches that we have just discussed. For example, in some embodiments, instead of using a sharp-tipped trocar that extends distally beyond the cutting surfaces of the external penetrator, a specialized needle is used that has a distal cutting tip. The needle can be attached to a obturator that does not extend beyond the distal face of the needle and is not involved in cutting or puncturing the skin. The needle itself can either have the ability to cut or slice through the skin to reach the bone, and it can also easily pierce through the hard bone to the marrow. The plug can prevent tissue debris from entering the needle lumen during insertion. These and / or other advantages of several disclosed modalities will be evident from the discussion that follows.
[0036] Figure 1 is an exploded view of a modality of an intraosseous access system 100, with some of its components shown in elevation and others shown in perspective. The intraosseous access system 100 can be used to penetrate the skin and underlying hard bone for intraosseous access, such as, for example,
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8/82 to access the patient's bone marrow and / or vasculature through a pathway through the inside of the bone.
[0037] In various embodiments, the system includes an actuator 101 and an access set 109. The actuator 101 can be used to rotate access set 109 on a patient's bone. In various embodiments, the driver 101 can be automated or manual. In the illustrated embodiment, driver 101 is an automatic driver 108. For example, automatic driver 108 can be a drill bit that achieves high speeds of rotation.
[0038] The intraosseous access system 100 may further include a obturator assembly 102, a guard 105, and a needle assembly 202, which can be referred to collectively as the access set 109. The access set 109 can also be referred to as an access system. Shutter assembly 102 is referred to herein as a convenience. In the illustrated embodiment, the obturator assembly 102 includes a obturator 104. However, in several other embodiments, the obturator 104 can be replaced by a different elongated medical instrument. As used here, the term elongated medical instrument is a broad term used in its common sense that includes, for example, devices such as needles, cannulas, trocars, obturators, stylets, etc. Consequently, the obturator assembly 102 can be referred to more generally as an elongated medical instrument assembly. Similarly, the obturator 104 can be referred to more generally as an elongated medical instrument.
[0039] In the illustrated embodiment, the plug assembly 102 includes a coupling hub 103 which is
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9/82 attached to shutter 104 in any suitable manner (for example, one or more adhesives or overmoulding). Coupling hub 103 can be configured to interface with driver 101, as discussed below. The coupling hub 103 may alternatively be referred to as a plug hub 103 or, more generally, as an elongated instrument hub 103.
[0040] In the illustrated embodiment, guard 105 is configured to couple with shutter 104. The coupling can allow relative longitudinal movement between shutter 104 and guard 105, such as sliding, translation or other movement along an elongation axis (i.e., axial movement), when guard 105 is in a first operating mode, and can prevent the same range of motion when guard 105 is transferred to a second operating mode. For example, as discussed below, guard 105 can attach to shutter 104 in a way that allows longitudinal translation when shutter 104 keeps guard 105 in an unlocked state, and when shutter 104 is moved to a position where it no longer holds the guard in the unlocked state, guard 105 can automatically transition to a locked state in which little or no translation movement is allowed between guard 105 and plug 104. In other words, guard 105 can be locked longitudinally for orientation fixed or substantially fixed longitudinal in relation to the obturator 104, where the protection 105 inhibits or prevents inadvertent contact with a distal end of the obturator, as discussed below. In various modalities, protection 105
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10/82 can be configured to rotate with respect to the plug 104 around a longitudinal axis of the plug 104 in one or more of the unlocked or locked states.
[0041] With continued reference to Figure 1, needle assembly 202 is referred to as such here for convenience. In the illustrated embodiment, the needle set
202 includes an needle 204. However, in several others modalities , a needle 204 can be replaced for one instrument different, such like, for example, a cannula, a tube or an sheath, and / or may be referred to by a name different, such as a or more of the previous examples. Per
Therefore, needle assembly 202 may be referred to more generally as a cannula assembly or as a tube assembly. Similarly, needle 204 can be referred to more generally as a cannula.
[0042] In the illustrated embodiment, needle assembly 202 includes a needle hub 203 which is attached to needle 204 in any suitable manner. The needle hub 203 can be configured to engage with the plug hub 103 and can thus be engaged with the driver 101, as discussed below. The needle hub 203 may alternatively be referred to as a cannula hub 203.
[0043] In the illustrated embodiment, guard 105 is configured to mate with needle hub 203. Coupling can prevent relative axial or longitudinal movement between needle hub 203 and guard 105, such as sliding, translation or the like, when guard 105 is in the first operating mode, and may allow guard 105 to disengage from needle hub 203 when guard 105 is in transition
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11/82 for the second operating mode. For example, as discussed below, guard 105 may couple to needle hub 203 so as to be held in a substantially fixed longitudinal position with respect to it when shutter 104 maintains guard 105 in unlocked state and when shutter 104 is moved to a position where it no longer holds the guard in the unlocked state, guard 105 can automatically transition to a locked state in relation to plug 104, in which state guard 105 also detaches from needle hub 203.
[0044] As discussed below, guard 105 can be attached to plug 104, plug 104 can be inserted into needle 204, and plug hub 103 can be attached to needle hub 203 to mount access assembly 109. On illustrated embodiment, a lid 107 can be provided to cover at least a distal portion of needle 204 and plug 104 prior to use of access assembly 109. For example, as discussed below, in the illustrated embodiment, a proximal end of the lid 107 can be coupled to the shutter hub 103.
[0045] With continued reference to Figure 1, the automatic trigger 108 can take any suitable form. The trigger 108 may include a handle 110 that can be gripped by a single hand of a user. Actuator 108 may further include an actuator 111 of any suitable variety through which a user can selectively actuate actuator 108 to rotate a coupling interface 112. For example, actuator 111 may comprise a button, as shown, or one
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12/82 switch or other mechanical or electrical element to drive the actuator 108. In the illustrated embodiment, the coupling interface 112 is formed as a socket 113 that defines a cavity 114. The coupling interface 112 can be configured to couple with the hub plug 103. In the illustrated embodiment, socket 113 includes side walls that substantially define a hexagonal cavity into which a hexagonal protrusion of the plug hub 103 can be received. Other suitable connection interfaces are contemplated.
[0046] Automatic actuator 108 may include a power source 115 of any suitable variety that is configured to energize the rotational motion of coupling interface 112. For example, in some embodiments, power source 115 may comprise one or more batteries that supply electrical power to the automatic actuator 108. In other embodiments, the power source 115 may comprise one or more springs (for example, a coil spring) or another pressure member that can store potential mechanical energy that can be released after actuation of actuator 111.
[0047] The power source 115 can be coupled with the coupling interface 112 in any suitable way. For example, in the illustrated embodiment, automatic actuator 108 includes an electrical, mechanical or electromechanical coupling 116 to a gear set 117. In some embodiments, coupling 116 may include an electric motor that generates mechanical movement from electrical energy supplied by an electrical power source 115. In other embodiments, coupling 16 can
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13/82 include a mechanical connection that mechanically transfers the rotational energy from a mechanical energy source (for example, spring-based) 115 to gear assembly 117. The automatic drive 108 may include a mechanical coupling 118 of any variety suitable for couple gear set 117 with coupling interface 112. In other embodiments, gear set 117 can be omitted.
[0048] In various embodiments, the automatic actuator 108 can rotate the coupling interface 112 and thus can rotate the access set 109 at significantly higher rotation speeds than can be achieved by manually rotating the access set 109. For For example, in various embodiments, automatic actuator 108 can rotate access set 109 at speeds of not less than 200, 300, 400, 500, 750, 1000, 1250, 1500, 1750, 2000, 2500 or 3000 revolutions per minute.
[0049] With reference to Figures 2 and 3, the obturator assembly 102, which includes the obturator hub 103 and the obturator 104, is shown in greater detail. In the illustrated embodiment, the plug hub 103 includes a body or housing 120. A proximal end of the housing 120 can be coupled with (for example, it can be attached to or can itself define) a coupling interface 122 for coupling with the interface coupling 112 of the actuator 101. In the illustrated embodiment, the coupling interface 122 is formed as a rod 123 which is configured to be received within the cavity 114 of socket 113 of the automatic actuator 108. In particular, the rod 123 can interact with the socket 113 so as to be
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14/82 round for that. In the illustrated embodiment, the stem 123 defines a hexagonal cross section that complements a hexagonal cross section of socket 113. Any other suitable arrangement is contemplated. In other embodiments, socket 113 and stem 123 can be inverted, where the
trigger 101 can include a stem and the cube shutter 103 maytrigger to define101. an outlet for to receive the rod of [0050]The interface coupling 122 of the cube shutter 103 can still include a ma member gnetic 124, that can to facilitate the coupling and / or can reinforce one
coupling between the coupling interfaces 122, 112 of the plug hub 103 and the driver 101, respectively. In various embodiments, the magnetic member 124 may include, for example, one or more of a ferromagnetic material and a ferromagnetic. In some embodiments, socket 113 may include a similar magnetic member that magnetically joins with magnetic member 124. In other embodiments, socket 113 itself may be formed as the magnetic member. For example, in some embodiments, magnetic member 124 may comprise a magnet and socket 113 may include a complementary magnetic member (not shown) at the base of cavity 114. In other embodiments, magnetic member 12 4 may comprise a magnet and socket 113 may be formed of a magnetic material to which the magnetic member 124 is attracted. In other embodiments, the magnetic member 124 may be omitted.
[0051] The body or housing 120 can also define a tightening 126 that can facilitate the manipulation of the shutter hub 103. For example, in the illustrated embodiment, the
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The clamp 126 is formed as a recessed region of a side wall 128 that encompasses a total perimeter of the housing 120.
[0052] The illustrated plug hub 103 includes a skirt 130 that extends distally from a central portion of housing 120. In the illustrated embodiment, skirt 130 is defined by a distal portion of side wall 128. Skirt 130 may include one or more mechanical coupling components 131 which are configured to selectively couple the plug hub 103 to the needle hub 203. In the illustrated embodiment, the skirt 130 includes two such mechanical coupling members 131 on opposite sides thereof. In particular, the illustrated embodiment includes two resilient arms or projections 132 that are capable of resiliently deforming in a lateral or radial direction. Each arm can include a plug-in interface, protrude inward, or lock 134 on an inner side that can interact with the needle hub 203 to achieve the coupling configuration.
[0053] In the illustrated embodiment, the obturator hub 103 further includes a pair of profusions outward 136 that can assist in coupling the lid 107 to the obturator hub 103. For example, in some embodiments, the lid 107 can define only one diameter internal diameter slightly larger than an outer diameter of the skirt 130. Outward profusions 136 may slightly deform a proximal end of the lid 107 from a substantially cylindrical shape to a more oblong shape, which may increase the tightness of the lid 107 against the exit 130. Any other connection arrangement suitable for the cover
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107 is contemplated.
[0054] Referring to Figure 3, the side wall 128 can further define a coupling interface 137 configured to couple the plug hub 103 to the needle hub 203 in a way that causes the plug hub 103 to rotate in unison with the needle hub 203. In the illustrated embodiment, the coupling interface 137 is formed as a socket 138 in which a stem portion of the needle hub 203 can be received. The socket 138 can define a key shape that allows the plug hub 103 to be coupled to the needle hub 203 in only a single rotational or angular orientation. In particular, in the illustrated embodiment, socket 138 defines an elongated straight octagonal prism from which five contiguous sides are substantially identically dimensioned, two enlarged sides extending from the ends of the five contiguous sides are elongated in relation to the five contiguous sides, and an eighth the short side that extends between the two enlarged sides is shorter than the five contiguous sides. Any other suitable switching configuration is contemplated. As further discussed below, a switched interface as just described can ensure that the plug 104 and needle 204 are coupled together in a manner that may be desired, in some embodiments, to ensure that the distal faces of both components substantially parallel to each other and / or to otherwise ensure that a distal face of the obturator 104 is positioned in a desired manner with respect to a distal face of needle 204. For example, in some embodiments, the
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17/82 keyed interface ensures that the distal faces of the plug 104 and needle 204 are substantially parallel to each other and / or ensures that the distal face of the plug 104 is fully recessed with respect to the distal face of the needle 204.
[0055] With continued reference to Figure 3, in some embodiments, the obturator 104 extends between a proximal end that is coupled to the obturator hub 103 and a distal end 142. The distal end 142 of the obturator 104 has a distal tip 146 at one its end. In the illustrated embodiment, the housing 120 of the plug hub 103 substantially encompasses the proximal end 140 of the plug 104.
[0056] The distal end 142 of the plug 104 includes a distal face 147, which can, in various embodiments, alternatively be referred to as a cut face, ground face or slanted face. In some embodiments, the distal face 147 is formed as a bevel that is at an angle relative to a central longitudinal axis of the obturator 104. For example, in the illustrated embodiment, the distal face 147 defines a substantially planar bevel. In some embodiments, the distal face 147 of the obturator 104 can be configured to be recessed in relation to a distal face of the needle 204 [0057] The chamfered distal face 147 can be formed in any suitable manner, such as by grinding. For example, the distal face 147 which is substantially planar can be formed by a pressure grinding (which can also be referred to as a simple pressure grinding). As further discussed
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18/82 below, in some embodiments, the ground distal face 147 is formed (e.g. ground) at a distal end of a substantially cylindrical stem, and the stem is bent after the distal face 147 has been formed. In other embodiments, the cylindrical rod is bent before the distal face 147 is formed. In still other embodiments, a cylindrical rod is not bent, but rather, each of the distal face 147 and a folded or rounded region 148 adjacent to it is, instead, formed by grinding. Other methods suitable for forming the distal end 142 of the plug 104 are contemplated.
[0058] In some embodiments, the shutter 104 can be solid. For example, the obturator 104 may be devoid of passages or openings that extend through any portion thereof. Similarly, the distal end 142 of the plug 104 may be substantially solid or closed, and may be devoid of openings or passages in or through it. The distal end 142 of the plug 104 can substantially fill a lumen of needle 204, or at least a distal portion of the lumen, to prevent skin or bone from entering needle 204 during an insertion event.
[0059] The plug 104 can be formed of any suitable material, such as a substantially rigid material that can resist bending. The material may be sufficiently rigid and strong to inhibit tissue and / or bone from entering the lumen of needle 204 during an access event. In various embodiments, the plug 104 may comprise one or more of a rigid plastic or stainless steel. The shutter 104 can, in some cases, provide
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19/82 internal or structural support to needle 204 during an insertion event. For example, obturator 104 can act as a stiffener or stylet to inhibit the curve of needle 204 during drilling.
[0060] The distal end 142 of the plug 104 can be shaped and sized to substantially fill a distal end of the needle 204 (see, for example, Figure 11A). In various embodiments, such an arrangement may inhibit the curve or flattening of the distal end of needle 204. For example, in some embodiments, there may be a tight fit between an inner wall of the distal tip of needle 204 and an outer surface of distal end 142 of the obturator 104, and the contact between these surfaces can allow the obturator 104 to reinforce the needle 204. For example, in the illustrated embodiment, the distal end 142 of the obturator 104 includes the folded region 148, which can also be referred to as a rounded region , bent or curved, or as a curved surface. An outline of the curved surface 148 can closely match an outline of an inner wall of needle 204 at its distal end (see, for example, Figure 11A). For example, in various embodiments, these curved surfaces may contact one another over a portion or substantially an entire length of the curved surface 148 of the plug 104 and / or a portion or substantially an overall length of the inner curved surface of the end away from needle 204.
[0061] In other cases, a small space or gap may be present between the distal end 142 of the
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20/82 obturator 104 and the inner surface of the distal end of the needle 204. In certain of these arrangements, the distal end 142 of the obturator 104 may not initially provide resistance against the curve of the needle tip. However, shutter 104 can instead prevent the needle tip from bending beyond a predefined amount. For example, by bending the needle tip, such that the inner wall comes into contact with the distal end 142 of the plug 104, the plug 104 can stop or further inhibit the curve of the needle tip.
[0062] In the illustrated embodiment, the obturator 104 may further include a recess 150. The recess 150 may be in a position that is between the proximal end and the distal end 142 of the obturator. In other words, the recess 150 can be positioned proximally to the distal end 146 of the obturator 104. The recess 150 can be of any suitable variety, such as a groove, track, or any other region of suitable indentation or reduced diameter. or reduced thickness, in comparison with, for example, a portion of the plug 104 that is proximal to the recess 150. The recess 150 may or may not extend completely around a longitudinal axis of the plug 104. In the illustrated embodiment, the recess 150 is defined as a groove 151 that extends completely around the longitudinal axis of the plug.
[0063] Figure 4 represents a perspective view of an illustrative modality of protection 105, which can also be referred to, for example, as a security protection, guard, clip, cover or element to prevent adhesion. Protection 105 includes a collar
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160 and a pair of arms 162, 163. In the illustrated embodiment, arms 162, 163 extend proximally from a proximal end of collar 160. As discussed below, arms 162, 163 can be resiliently flexible members. The arms 162, 163 can be formed in such a way that they are in a natural state, at rest, not deflected, not dislodged, not deformed, not distorted, not flexed or relaxed when in the low profile orientation shown in Figure 4, or are at least closer to such a low energy state than when they are moved to an out-shifted state as shown in Figures 11 A, 11 C and 11 D. For example, arms 162, 163 can be deformed, displaced , flexed or deflected laterally or radially outwards away from a longitudinal axis of protection 105 to obtain an orientation such as that shown in Figures 11A, 11 C and 11 D, which can give
source to a internal pressure that naturally drives the arms 162, 163 back ac > its natural state or in direction to a[0064] energy stateProtection 105 bottom.you can define a far end distant 16 4 e one end proximal 165. In modality
shown, collar 160 is positioned at the distal end 164 of the guard. The illustrated collar 160 defines a substantially rectangular cross section, although other configurations are contemplated. The collar 160 can define a distal tip 166 or distal edge of the guard 105. In the illustrated embodiment, distal tip 166 includes a substantially flat face.
[0065] The collar 160 can define a distal opening
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7 through which the shutter can pass. In various embodiments, the distal opening 167 can define a fixed open configuration. In other embodiments, aperture 167 is configured to remain open even after distal tip 146 of plug 104 has been pulled into guard 105. In other words, collar 160 may be substantially non-deformable or may define a unique shape during full protection operation 105.
[0066] As discussed below, in some embodiments, collar 160 is able to inhibit or prevent unwanted contact with distal tip 146 of shutter 104, although distal opening 167 remains open when guard 105 is blocked in shutter 104. For example , the distal opening 167 can be sized to prevent the skin of a user or other individual from entering a cavity 169 of the guard 105 at a sufficient distance to contact the distal tip 146 of the obturator 104.
[0067] In the illustrated embodiment, cavity 169 is generally defined by collar 160, distal ends of arms 162, 163, and a pair of panels 181, 182. Put another way, a cage 180 or receptacle can be defined by collar 160 , arms 162, 163, and panels 181, 182. Cage 180 can prevent inadvertent contact with distal tip 146 of plug 104 when distal tip 146 has been pulled in and is retained therein.
[0068] In the illustrated embodiment, panels 181, 182 can also be referred to as deflection arms or retainers (for example, arms 181, 182). Similar to arms 162, 163, arms 181, 182 can be naturally
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23/82 pressed to the natural configuration shown in Figure 4 in which arms 181, 182 are angled inward, in a distal-to-proximal direction, in the direction of a longitudinal axis of guard 105. Arms 181, 182 can be deflected outwardly by a proximal portion of the plug 104, and the proximal ends of the arms 181, 182 may, of course, jump into the groove 151 as the plug 104 is sucked proximally through the guard 105.
[0069] In the illustrated embodiment, at the proximal end 165 of the protection 105, the arms 162, 163 define lateral extensions 172, 173, respectively, which can extend in opposite directions. The side extensions 172, 173 can define the openings 174, 175 through which the plug 104 can pass. The openings 174, 175 can be in the form of a key with enlarged regions that allow ready passage of the shutter 104 and narrow portions that are configured to enter the groove 151 of the shutter 104 to block, delimit, inhibit or prevent axial movement between the guard 105 and the plug 104. In the illustrated embodiment, the openings 174, 175 are substantially identical in shape to one another, but are oriented in opposite directions. The enlarged portions of the openings 174, 175 are formed substantially as semicircles, and the constricted portions of the openings 174, 175 are configured substantially as rectangles. Other configurations are contemplated.
[0070] In some embodiments, one or more of the arms 162, 163 can define one or more connection interfaces 176, 177, respectively, which can engage the hub
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24/82 of needle 203, as discussed below. In the illustrated embodiment, connection interfaces 176, 177 are directed outwardly to engage needle hub 203 when the arms are deformed or distorted outward and are held in this outward orientation by the larger diameter portion of the plug 104. In the illustrated embodiment, the connection interfaces 176, 177 are formed as outwardly directed profusions 178, 179. For example, in the illustrated embodiment, the 178, 179 profusions are formed as external curves in the arms 162, 163, respectively.
[0071] In various modalities, the protection 105 can be formed from a single monolithic piece of material, or put another way, it can have a single piece construction. For example, in some embodiments, guard 105 may be formed by a single sheet piece (for example, stainless steel) that has been folded and / or curved in the configuration shown in Figure 4. For example, in the illustrated embodiment, guard 105 it is folded into a substantially rectangular shape in four primary folds, one at each corner of the collar 160. Additional folds (in some cases, two folds each) produce each of the side extensions 172, 173. In some embodiments, the additional folds (in in some cases, three folds each) produce the outward streaks 178, 179. When folding or bending the single sheet of metal, opposite edges of the sheet may be in contact or in close proximity to one another along a 185 seam. illustrated, seam 185 extends longitudinally along arm 181. In other embodiments, seam 185 may instead be located in one of the folds of collar 160, so as not to
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25/82 be present along or through any of the arms 162, 163, 181, 182.
[0072] In other modalities, the protection 105 can be molded by injection, printed in 3D, or formed in any other suitable way. In other additional embodiments, the guard 105 can be formed of multiple pieces that are joined.
[0073] With reference to Figures 5 and 6, as discussed above, needle assembly 202 may include needle hub 203 and needle 204, which can be fixedly attached to each other in any suitable manner (for example, a or more adhesives or overmoulding). In addition, as discussed earlier, needle hub 203 and needle 204 may, more generally, be referred to as a cannula cube and as a cannula, respectively.
[0074] In the illustrated embodiment, the needle hub 203 includes a housing or body 208. The body 208 can define a coupling interface 210 that is configured to mate with the coupling interface 137 of the plug hub 102 (see Figure 3) . For example, the coupling interface 210 can be formed as a rod 212 which is configured to be received inside the socket 138 of the plug hub 102 (see Figure 3). As shown in Figure 5, in some embodiments, stem 212 can define a key shape that allows needle hub 203 to be coupled to plug hub 103 in only a single rotational or angular orientation. In particular, in the illustrated embodiment, stem 212 defines an elongated straight octagonal prism, of which five contiguous sides are substantially of identical size, two sides enlarged
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26/82 extending from the ends of the five contiguous sides are elongated in relation to the five contiguous sides, and an eighth short side that extends between the two extended sides is shorter than the five contiguous sides. The shape of the prism can be substantially the same as that defined by the coupling interface 137, but with slightly shorter sides. Any other suitable switching configuration is contemplated.
[0075] The needle hub 202 may further include a connector 220, for example, a medical connector, of any suitable variety. Connector 220 can be defined by housing 208 and can extend proximally from stem 212. Connector 220 can be configured to mate with any suitable medical equipment, such as to infuse fluid into a patient, after needle 204 has been inserted into the bone. For example, in the illustrated embodiment, connector 220 is formed as a Luer socket 221 (i.e., a female Luer socket). The illustrated Luer fitting 221 includes a side wall 222 that defines a cavity or lumen 224. In some embodiments, a portion of a male Luer fitting may be received within the lumen 224 when the needle hub 202 is in use. The lumen 224 of the connector 220 may be in fluid communication with a lumen 251 of the needle 204, which is discussed further below.
[0076] In the illustrated embodiment, the side wall 222 defines a connection interface 226 that is configured to couple the needle hub 202 with the guard 105 when the guard 105 is in the unlocked state in relation to the plug 104. In this state, the guard 105 can also be referred to as being in a locked or engaged state
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27/82 in relation to the needle hub 202. For example, in the illustrated embodiment, the connection interface 226 is formed as an annular groove 227 within which the protrusions 178, 179 of the guard 105 (see Figures 4, 11 A and 11 D) can be received to prevent guard 105 from moving at least in a longitudinal direction with respect to needle hub 202.
[0077] The housing 208 can also define a skirt 228, which can extend distally from the stem 212. The skirt 228 can also extend outwardly in relation to the stem 212. The skirt 228 can define a maximum transverse perimeter 230 of the hub 202. In the illustrated embodiment, the maximum transverse perimeter 230 is substantially circular. The maximum transverse perimeter 230 represents an outline of the needle assembly 202 when the assembly 202 is viewed from above or below, or otherwise indicated, is viewed along a longitudinal axis of the needle assembly 202.
[0078] With reference to Figure 6, an upper interior region of the side wall 222 can define a maximum transverse perimeter 232 of the lumen 224. In the illustrated embodiment, the maximum transverse perimeter 232 is substantially circular. In other embodiments, the maximum transverse perimeter 232 can be defined by a portion of the side wall 222 that is positioned lower within the lumen 224, and may not, for example, be visible in a top view of the needle hub 203. In still other embodiments, the maximum transverse perimeter 232 represents an outline of the lumen 224 when the assembly 202 is viewed from above, or otherwise indicated, is seen
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28/82 along a longitudinal axis of the needle assembly 202.
[0079] With continued reference to Figure 6, needle 204 may include a proximal end 240 and distal end 242. Proximal end 240 ends at a proximal end 244, and distal end 242 ends at a distal end 246. The tip distal 246 can also be referred to as the most distal point of needle 204. Proximal end 240 can be fixedly attached to housing 208 in any suitable manner. Needle 204 can be formed of any suitable material. For example, in some embodiments, needle 204 is formed of stainless steel, such as stainless steel 304, stainless steel 316, or any other suitable type of stainless steel (for example, as it can be used for hypodermic needles). The material may desirably be rigid enough to puncture a layer of tissue and penetrate hard bone.
[0080] With reference to Figures 6 and 7, the distal end 242 of the needle 204 can include a distal face 247, which can, in various embodiments, alternatively be referred to as a cut face, ground face or angled face. In some embodiments, the distal face 247 is formed as a bevel that is at an angle relative to a central longitudinal axis A _L of needle 204, which may correspond to a axis of rotation of needle 204 during an insertion event. For example, in the illustrated embodiment, the distal face 247 defines a substantially flat bezel. The bevel plane is identified as P in Figure 7. The chamfered distal face 247 can be formed in any suitable way, such as by
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Grinding. For example, the distal face 247 which is substantially flat can be formed by a pressure grinding (which can also be referred to as a simple pressure grinding). As further discussed below, in some embodiments, the ground distal face 247 is formed (e.g. ground) at a distal end of a substantially cylindrical tube, and the tube is folded after the distal face 247 has been formed. In other embodiments, the cylindrical tube is folded before the distal face 247 is formed.
[0081] With reference to Figure 7, the illustrated distal face 247 is at an angle α in relation to the central longitudinal axis A _L. Any suitable value of angle a is considered. For example, in various embodiments, the angle α is within a range of about 8 degrees to about 20 degrees; it is not less than 8, 10, 15 or 20 degrees; or it is not greater than about 8, 9, 10, 15 or 20 degrees. In some embodiments, the angle α is approximately 11 degrees.
[0082] As shown in Figure 11 A, in the illustrated embodiment, when the plug 104 is fully inserted in needle 204, its distal face 147 is slightly lowered in relation to distal face 247. The distal face 147 can be substantially parallel to the face distal 247 from needle 204, or may be oriented at a small angle to distal face 247, the angle having a value of no more than 1, 2, 3, 4, 5 or 10 degrees. In addition, the central longitudinal axes of each of the obturator 104 and the needle 204 can be aligned or collinear, and can
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30/82 correspond to a central longitudinal axis A _l _ _S ys of the access system or access set 109, which can also be the axis of rotation of the access set 109. In some embodiments, the distal face 147 can define an angle in relation to the central longitudinal axis which is not more than about 8, 9, 10, 15 or 20 degrees. In some embodiments, such as certain embodiments for which the angle α defined by the distal face 247 of the needle 204 is approximately 11 degrees, the angle defined by the distal face 147 of the plug 104 is approximately 9.5 degrees.
[0083] With reference to Figures 7 and 9, the distal end 242 of needle 204 can include a folded or rounded region 248, which can be joined to an edge of distal face 247 and can extend from it around a periphery from the distal end 242. In a plane that passes through the longitudinal axis A _L of needle 204 and that is perpendicular to the plane P defined by the distal face 247 (that is, the plane of the page in Figure 7), a tangent TAN to the rounded region 248 at or adjacent to the distal tip 246 can define an angle β in relation to the longitudinal axis A _L. Any suitable value of angle β is considered. In some cases, angle β is approximately the same or slightly greater than angle a. Together, the angles α and β can be small enough to provide a sharp distal tip 246 that can easily cut through the skin. For example, in various modalities, the angle β is within a range of about 8 degrees to about
of 25 degrees; is not less than about in 8, 10, 15, 20 or 25 degrees; or not is greater than about 8, 9, 10, 15, 20 or 25 degrees. In some modalities, O angle β is in
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31/82 approximately 15 degrees. In various embodiments, the combined angles a and β (or otherwise indicated, a cutting angle of the distal tip 246) are not greater than 15, 20, 25, 30, 35 or 40 degrees.
[0084] When needle 204 is advanced in a distal direction, the sharp distal tip 246, as defined by distal face 247 and the rounded region 248, can allow the distal end 242 of needle 204 to easily pierce or cut through the fabric. For example, in some cases, the distal end 242 of needle 204 can be advanced distally, substantially without rotation around the axes A _L , A _l _ _S ys and can cut through tissue, just as in a scalpel-like manner . The distal tip 246 can finally come into contact with the bone, at which point the needle 204 can be rotated to cut through the bone.
[0085] Referring again to Figures 6 and 7, in the illustrated embodiment, needle 204 includes a stem 250 that is fixedly attached to hub 203 at its proximal end. The stem 250 extends distally and ends where the distal end 242 of needle 204 begins. In the illustrated embodiment, a border between the distal end of the stem 250 and the proximal end of the distal end 242 of the needle is illustrated by a horizontal dashed line in Figure 7. The distal end 242 of the needle 204 extends downward from that border ends at distal tip 246. As shown in Figure 5, an outer surface of the stem 250 may include one or more depth markers 258 of any suitable variety.
[0086] In the illustrated embodiment, the needle rod
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32/82
250 is substantially cylindrical, on each of an internal and external surface thereof. Needle stem 250 can also be said to define circular inner and outer lateral cross sections (which can also be referred to as cross sections), each having a constant diameter along a complete longitudinal length of stem 250. Other arrangements are also available. contemplated. For example, in some embodiments, the stem 250 may be substantially shaped like a frustoconus, and may have a very gradual cone, such that the diameter of one or more of its internal or external circular cross sections decreases in the distal direction. However, in some cases, it may be desirable for the needle stem 250 to have a substantially cylindrical outer surface, as this may inhibit or prevent the needle 204 from leaving the bone after implantation, and may also inhibit or prevent extravasation. at the insertion site.
[0087] In the illustrated embodiment, the distal end 242 of needle 204 does not define a constant external lateral cross-sectional area, in relation to the longitudinal axis A _L , along its total length. For example, as can be seen in Figure 7, the rounded region 248 and the distal face 247 taper towards the distal tip 246. It can be said that the needle tip 246 is
house in direction to axis central longitudinal A _L gives needle 204. As a contour rounded region 248 is followed in one direction distant, the contour if
continuously closer to the central longitudinal axis A _L of needle 204. As discussed below, the distal tip 246
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33/82 can be positioned on or near the longitudinal axis
central A _L gives needle 204, how represented in modality illustrated.[0088]distal 242 gives In the illustrated embodiment, needle 204 defines, however, far endan area of
constant internal cross-section, or substantially constant, in relation to a central line C passing
across a center of lumen 251 to long in one length significant from the end distant 242. 0 lumen 251 is defined by a surface internal 252 gives
needle 204, and the center line C can be defined as a line extending through a center of each plane that is bounded by the inner surface 252 and which contacts the inner surface 252 at right angles around a total periphery of the plane. According to this definition, the central line C ends when a transversal plane through it contacts the upper end of a distal opening 260 of the lumen 251. That is, in Figure 7, according to the previous definition of the central line C, the center line C ends at the position of the cross-section plane demarcated by lines of sight 8C-8C. This is because, below this point, no plane that contacts the inner surface 252 at right angles is completely bounded by the inner surface 252, due to the presence of the opening 260.
[0089] In other embodiments, the inner surface 252 can be projected outwardly through the distal opening 260 of needle 204, as represented by the dashed lines labeled PROJ _IN in Figures 7, 8D and 8E. In some cases, depending on the way in which the 204 needle was formed, this projected surface may correspond to the
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34/82 inner surface of a portion of a tubular element that was ground during the formation of distal end 242 of needle 204. In some cases, the center line C can be defined as a line extending through a center of each plane which is bounded by one or both of the internal surfaces 252 and the PROJi _N projection and which contacts one or both of the internal surfaces 252 and the PROJ _in projection at right angles over a complete periphery of the plane. In the illustrated embodiment, an area of lateral internal cross section A (Figure 8A-8E) defined by both the inner surface 252 and its projection PROJin, in relation to the central line C, can be substantially constant along the entire length of the distal end 242, as shown in Figures 7 and 8A-8E. In various embodiments, the lateral internal cross-sectional area A, which is defined in relation to the centerline C (according to one or both of the definitions of centerline C provided above), varies over a total needle length of more than 5, 10, 15, 20, 25, 30, 35, 40, 45 or 50 percent of a maximum value for area A.
[0090] In some embodiments, it may be advantageous to have a relatively large or unimpeded lumen 251 over a total length of the needle 204 and / or over a length of the needle that extends proximally from the distal opening 260. For example , in some cases, such a large or unobstructed passage may facilitate or allow the use of the shutter 104, if in general or, more particularly, for use as a stiffener. In other cases or additional cases, such a passage may allow relatively high flow rates for infusion or
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35/82 aspiration through lumen 251, or in other cases, can prevent the introduction of resistance or restriction in a system that may already be limited, restricted or constrained. For example, in some cases, such as in certain emergency situations, it may be desirable to deliver drugs in solution to the patient's vasculature through the lumen 251, which provides a pathway for a patient's bone. In such circumstances, a practitioner can attach a medication delivery bag (e.g., IV) to needle 204 and squeeze the bag to force the solution onto the patient's bone. The bone and / or its internal structure and / or native pressure in it can limit the speed with which the solution can be introduced into the bone through this approach. Consequently, it may be desirable to reduce any other constriction of the system, such as it may result from a partially blocked or constricted lumen 251. In other cases or additional cases, it may be desirable for the needle 204 to have a relatively small outside diameter, such as to reduce discomfort to the patient and / or to facilitate healing of skin and bone tissue after a procedure. However, in still other applications, it may be desirable for needle 204 to be large enough to have sufficient columnar strength to withstand the static and inertial loads provided during an insertion event. In various embodiments, providing needle 204 with a relatively large and / or relatively clear lumen 251 can achieve or balance some or all of the above objectives, depending on the intended use of needle 204.
[0091] In several modalities, the OD of the 204 needle
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36/82 cannot be less (that is, not greater than) than 17, 16, 15, 14 or 13. To put it another way, in various modalities, the OD of the needle cannot be greater than about 58, 65 , 72, 83 or 95 thousandths of an inch (about 1.5, 1.7, 1.8, 2.1 or 2.4 millimeters). In some embodiments, the OD is about 15 gauge (about 72 thousandths of an inch, or about 1.8 millimeters). Other sizes are also possible. For example, in some cases, the previous sizes may be advantageous for infusion applications, while larger sizes may be desired for certain biopsy or aspiration applications.
[0092] In certain embodiments, such as various embodiments having an OD within the discussed size ranges, a thickness of the needle sidewall 204 cannot be greater than 5, 10, 15 or 20 thousandths of an inch. In some embodiments, where the OD is about 15 gauge (about 72 thousandths of an inch), the wall thickness cannot be greater than about 10,000 of an inch.
[0093] In certain embodiments, such as various embodiments having an OD and / or a wall thickness within the size ranges discussed, needle 204 may allow a flow rate of about 1 liter per hour (as for infusion in a tibia) or a flow rate of around 4 liters per hour (such as for infusion in a humerus). Needle 204 may also be able to withstand fluid distribution at the preceding rates over a wide variety of pressures, as may result from a professional squeezing into an IV bag or the like.
[0094] With reference to Figures 7, 9A and 9B, as
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37/82 mentioned above, in the illustrated embodiment, an outer surface of the stem 250 is substantially cylindrical, whereas an outer surface of the distal end 242 is not. Therefore, needle 204 defines a lateral external cross section (with respect to the longitudinal axis A _L ) that is substantially circular along the entire longitudinal length of the stem 250 (see, for example, Figure 8A). In addition, the substantially circular outer cross section defines an OD outer diameter that is substantially constant over a complete longitudinal length of the stem 250. In some embodiments, it may be desirable for the distal end 242 of needle 204 to have a lateral outer cross section. , in relation to the longitudinal axis A _L (corresponding to the axis of rotation), which is not larger than the circular lateral external cross section of the stem 250. For example, as seen in Figures 9A and 9B, the cylindrical outer surface of the stem 250, which is substantially circular in an end view, is not obstructed from view by any portion of the distal end 242 of needle 204. In other words, the outer surface of the stem 250 may define a lateral or transverse perimeter 253, which in some modalities is substantially the same in any cross-section plane that extends orthogonally across the long axis itudinal AL, and in the illustrated embodiment, the lateral perimeter 253 is substantially circular. As used herein, the term substantially circular means that a shape exhibits a generally circular or oval profile and that its maximum diameter is not more than 10 percent greater than its
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38/82 minimum diameter. In the illustrated mode, when the needle
204 is rotated to drill a hole, such as through
hard bone, the rod 250 can to fit in perfectly inside the hole.[0095] At relations in between the 250 stem and the far end distant 242 (or portion cutting) others modalities additional or additional modalities of 204 needle can to be described in other terms Such
needles 204 may also be able to create a hole with distal end 242 which is sized to allow comfortable reception of stem 250. For example, in some embodiments, along a full longitudinal length of distal end 242, each side (in relation to the longitudinal axis A _L ) the outer cross section of the distal end 242 can be totally or partially circumscribed by the smaller lateral outer cross section of the stem 250. In other additional modalities or modalities, a maximum width (for example, diameter) of each lateral external cross-section of the distal end 242 may be no larger than the smallest external dimension (e.g., outer diameter) of the stem 250, such as at the distal end of the stem 250. In certain embodiments, no portion of each external cross section side of the distal end 242 extends beyond (that is, extends laterally further out) a transverse section profile lateral external ersal of at least a distal portion of the stem 250.
[0096] In some modalities, as in the illustrated modality, it can be stated that in no position along a total longitudinal length of the needle 204 to
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39/82 outer surface of the needle extends beyond a perimeter of an external lateral cross section of the stem 250. In some embodiments, as in the illustrated embodiment, it can be established that in no position along a complete longitudinal length of the distal end 242 of the needle 204 the outer surface of the distal end 242 extends laterally outwardly beyond a perimeter of a lateral external cross section of the stem 250. Otherwise, in all positions along a complete longitudinal length of the distal end 242 of the needle 204, the outer surface of the distal end 242 extends laterally outwardly relative to the longitudinal axis A _L no more than a lateral or transverse perimeter 253 of the outer surface of the stem 250, for example, the perimeter at a more distal end of the stem 250 to the along a plane that is orthogonal to the longitudinal axis A _L (see Figures 9A and 9B).
[0097] In certain embodiments, the distal end 242 of needle 204 may define a constant lateral, or substantially constant lateral cross-sectional area in relation to the central line C that passes through a center of the lumen 251 and / or the PROJ projection _IN . In other embodiments, the outer surface of needle 204 can be designed in a similar way to the internal projection PROJin, as represented by the dashed lines labeled PROJqut in Figures 7, 8D and 8E. In some cases, depending on the way in which the needle 204 was formed, this projected outer surface may correspond to the outer surface of a portion of a tubular element that was ground during the formation of the distal end 242 of the
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40/82 needle 204. In the illustrated embodiment, an area of lateral external cross section (Figures 8A-8E) defined both by the external surface and by its PROJ _OUT projection, relative to the center line C, can be substantially constant throughout the distal end length 242, as shown in Figures 7 and 8A-8E. In various embodiments, the area of lateral external cross-section, which is defined in relation to the center line C (according to one or both of the definitions of center line C provided above), varies over a total needle length by no more of 5, 10, 15, 20, 25, 30, 35, 40, 45, or 50 percent of its maximum value.
[0098] Likewise, as shown in Figures 8A-8E, the OD outer diameter can be substantially along the center line C. In various embodiments, the OD outer diameter can vary over a total needle length by no more than 5, 10, 15, 20, 25, 30, 35, 40, 45 or 50 percent of a maximum value thereof.
[0099] With continuous reference to Figures 8A-8E, a series of external cross-sectional perimeters 261A261E, relative to the center line C in Figure 7, are shown. In these images, the outermost perimeter 261A261E of needle 204 in each plane of cross section appears to be substantially circular (Figures 8A-8C) or substantially semicircular (Figures 8D and 8E). In various embodiments, at least a portion of one or more of the outer perimeters 261 B-261E of the distal end 242 are slightly deformed because they are perfectly circular or perfectly semicircular, however. For example, as discussed below, in some cases, training
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41/82 of the distal end 242 may involve fixation, driving, compression, or otherwise restrict or otherwise form the distal end 242 to ensure that no portion of it extends transversely outward (relative to the longitudinal axis A _L ) in addition to the outer periphery 261A of the stem 250. This process can deform at least a portion of the outer and / or inner surfaces of the distal end 242 of needle 204 to deviate slightly from the definition of a true circle or a true semicircle within transverse planes which are transversal to the center line C.
[00100] With continued reference to Figures 8A-8E, in relation to the inner surface 252 of needle 204, the transverse inner perimeter, in relation to the central line C (see Figure 7), can be substantially circular or substantially semicircular. For example, in each of Figures 8A, 8B and 8C, the internal diameters in two mutually orthogonal directions are substantially the same. That is, the internal diameters shown in Figures 8A, 8B and 8C are all substantially the same and are therefore identified as IDi. In some embodiments, however, one of the diameters (for example, the vertically oriented diameter in the illustrated view) may be slightly smaller than the other diameter (for example, the horizontally oriented diameter in the illustrated view) in one or more of Figures 8B or 8C due to slight deformations of the tube during the formation of the distal end 242. However, the cross section profile can remain substantially circular.
[00101] Similarly, in Figures 8D and 8E, where the
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42/82 inner perimeters of surface 252 are bounded by the distal face 247 of needle 204, the inner diameter of the inner perimeter in one dimension can be substantially the same as in the regions most proximally located on needle 204. For example, the vertically oriented diameter on the illustrated view for each of Figures 8D and 8E is identified as ID1. In some embodiments, however, these vertically directed diameters, in the illustrated views, may be slightly smaller than the similarly oriented diameters of the more proximal portions of the distal end 242, such as in the positions of one or more of Figures 8B or 8C , due to slight deformations of the tube during the formation of the distal end 242. However, the cross section profile can remain substantially semicircular.
[00102] In some embodiments, the substantially circular geometries of needle 204, as described above, can advantageously resist buckling, flexing or bending of the distal end 242 when needle 204 is pressed against bone during an insertion event and / or turnover at high rates. For example, the distal end 242, or any part of it, is much less prone to buckling, flexing or bending due to the geometries described above, compared to certain arrangements that may, for example, have a thinner, flatter profile and / or more oval. This can be demonstrated, for example, from an application of Euler's critical load formula, in which the critical load that can be supported by a column is directly proportional to the minimum moment of inertia of the cross-sectional area of
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43/82 one column. For a given maximum outer diameter of a column - in this case, the distal end 242 of the needle (204), or considered in isolation or considered collectively with at least a portion of the stem (250), circular geometries are less prone to buckling, in comparison with thinner, flatter and / or more oval shaped profiles, due to the symmetries of the area's moments of inertia for the circular geometries. Thus, for example, with reference to Figure 9A, due to the substantially circular geometries discussed above, the distal end 242 may have approximately the same buckling resistance around the y axis as it does with respect to the x axis.
[00103] With reference again to Figure 7, the distal face 247 can define a longitudinal height H, which can be the longitudinal component of a maximum length of face 247, or, otherwise, it is the distance that face 247 extends longitudinally. . In various embodiments, the longitudinal height H is about 0.1, 0.15, 0.2, 0.25 or 0.3 inches; is not greater than about 0.1, 0.15, 0.2, 0.25 or 0.3 inches, or is not less than about 0.1, 0.15, 0.2, 0.25 or 0.3 inches. Any other suitable height is possible.
[00104] The longitudinal height H of the distal face 247 can be a significant percentage of the overall longitudinal length L of the distal end 242. In various embodiments, the longitudinal height H of the distal face 247 cannot be less than about 50, 60, 70 , 80 or 90 percent of the longitudinal length L of the distal end 242. In some embodiments, the longitudinal height H of the distal face
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44/82
247 can be substantially equal to the longitudinal length L of the distal end 242.
[00105] The rounded region 248 can extend along the total longitudinal length L of the distal end 242. The radius of curvature of the rounded region 248 can be relatively large, or to put it another way, the deflection of the outer surface of the distal end 242 towards the longitudinal axis AL can be gradual. Such an arrangement can contribute to the sharpness of the distal tip 246 and facilitate the insertion of the needle 204 through the skin tissue. In other cases or additional cases, such an arrangement may be relatively resistant to bending, bending or buckling, due to a slight deviation from the central line C (which passes through the center of the circular geometries) from the longitudinal axis AL of needle 204. For example , a static load can be applied along axis A _L of needle 204 as a professional presses down or distally on the automatic actuator 108 and as the distal tip 246 of the needle presses against the bone. The total length of the needle 204 supports this load, and the stable circular geometry that extends along this total length, with only small deviations from the distal end 242, allows the needle 204 to support the load without buckling (for example, in a center needle 204, or elsewhere). The circular configuration can be similarly resistant to inertial loads that result from high rotation speeds of the needle 204.
[00106] In various modalities, the length of the rounded region 248 (which in the illustrated modality is equal to L) is not less than about 2, 2.5, 3, 3.5 or 4 times
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45/82 greater than the OD of the stem 250. In some embodiments, the OD is approximately 72 thousandths of an inch, and the length L is about 212 thousandths of an inch. In some embodiments, a radius of curvature of the rounded region 248 is substantially constant and / or the curvature of the rounded region 248 is substantially monotonous (for example, it progresses only towards, or only approaches, the longitudinal axis A _L in proximal-to-distal direction). In various embodiments, the length L of the rounded region 248 may not be less than 4, 5, 6, 7, 8, 9 or 10 times a total needle length 204.
[00107] With reference to Figure 10, the distal end 242 of needle 204 may include a cutting edge or cutting region 270. Cutting region 270 may include a cutting edge 271 and a cutting face 272. In the illustrated embodiment , the cutting edge 271 is a continuously rounded edge that extends from one side of needle 204 to an opposite side of it. Two opposing upper ends of the cutting edge 271 are spaced apart by a distance equal to the OD outer diameter of the stem 250. In other words, the cutting edge 271 extends from one side of the OD of the needle 204 to one opposite side of the OD. The cutting face 272 can be a lower portion of the distal face 247 which can contribute to cutting through the bone and / or displacing the cut bone material. In some cases, the cutting face 272 ends in a position where one of its outer diameter corresponds to the OD of the needle 204.
[00108] The cutting edge 271 can include the tip
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46/82 distal 246, which can be positioned at the nadir of the cutting edge 271. In the illustrated embodiment, the distal tip 246 is positioned at the cutting edge 271 and on the longitudinal axis A _L. The cutting region 270 can thus rotate about the longitudinal axis A _L , or around the distal tip 246, during drilling in a patient's bone. In some cases, the driver 101 (see Figure 1) can rotate the needle 204 in a single direction, such that only half of the cutting region 270 can cut bone during the insertion event. For example, in the illustrated modality, if the needle were turned clockwise, seen from above, the portion of the cutting region 270 that is to the right of the longitudinal axis A _{L would} contribute to the cut, whereas the left portion would not; conversely, if the needle were turned counterclockwise, the opposite would be true. In some cases, needle 204 can be rotated in only one direction during drilling, such as through certain modalities of automatic actuator 108.
[00109] In other arrangements, needle 204 can be rotated back and forth in opposite and first opposite directions, respectively, and both portions of the cutting region 270 can contribute to the cutting of the bone. In other words, needle 204 can be rotated back and forth, or in opposite directions, and can cut bone in each stroke. That is, needle 204 can cut in opposing directed courses and, in other embodiments, it can do equally well in each opposing directed course. Put in yet another way, needle 204 can cut bi-directionally. In some cases, such forward and backward cutting movements can be used
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47/82 during manual manipulation of needle 204, such as when the actuator 101 is a manually manipulated handle.
[00110] In certain embodiments, such as that illustrated in Figure 10, the slope of a tangent line at each point along the cutting edge 271 transits smoothly from one end of the cutting edge 271 to its opposite end. In other words, the cutting edge 271 may, in some embodiments, be a smooth, rounded surface that is devoid of sharp edges or corners or, to put it another way, for which the slope of the tangent line is devoid of discontinuities. This can be true generally, or in some embodiments, it can only be specifically true locally on a central portion of the cutting edge 271, such as in a region that includes the distal tip 246. For example, instead of reaching a sharp point at the distal end 246, the cutting edge 271 can be a rounded or smooth curve.
[00111] In the illustrated embodiment, the tangent T to the cutting edge 271 at the distal end 246 is substantially orthogonal to the longitudinal axis A _L. In other words, the tangent T is collinear with an orthogonal line O which passes through the distal tip 246 and is at a 90 degree angle to the longitudinal axis A _L. In other embodiments, the tangent T at the distal tip 246 defines an angle relative to the orthogonal line O, which is not greater than about 10, 15, 30 or 45 degrees.
[00112] In some cases, it may be desirable to have little or no angle between the tangent T at the distal tip 246 and the orthogonal line O, and also, for the slope of the tangent T to be continuous or to make the transition
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48/82 smoothly from one side of the distal tip 246 to the other. In certain configurations, such an arrangement can result in a wide cutting region 270 close to distal tip 246. In other words, such an arrangement can produce a rounded cutting edge 271 and a cutting face 272 which are also close to the orthogonal line O , or to put it another way, that longitudinally are relatively close (that is, that they are close in the axial direction) to the distal tip 246. The cutting edge 271 and the cutting face 272 can thus more readily cut the bone to size that needle 204 is rotated around distal tip 246, as these surfaces on both sides of distal tip 246 are capable of translational movement with respect to bone. In some cases, it is mainly or exclusively the translation movement of the cutting edge 271 and the cutting face 272 in relation to the bone surface that scrapes layers of bone material, or pierces through the bone, as the needle 204 is advanced distally. Therefore, in some cases, it may be desirable for the cutting edge 271 to be wide, or to extend outwardly away from the longitudinal axis A _L , in the vicinity of the distal tip 246.
[00113] In some embodiments, a wide cutting edge, extending outward, 271 may cut better or more smoothly than a distal tip 246 that is quite pointed or, to put it another way, for which a slope of the tangent T is discontinuously and abruptly changes from a low negative value to a high positive value at the distal tip 246. For example, some very sharp distal tips 246 can define an angle that is no more than 15 or 30 degrees. In some modalities, the distal tip
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49/82
246 can reach a point (for example, the tangent T can be discontinuous there, instantly changing from a negative value to a positive value), but an angle defined by that point can be relatively large to facilitate cutting, and may not be less than, for example, about 45, 60, 75, 90 or 105 degrees.
[00114] In some embodiments, the cutting edge 271 is symmetrical in relation to the longitudinal axis A _L. In some cases, such an arrangement may inhibit needle 204 oscillation during drilling.
[00115] In some embodiments, such as the illustrated embodiment, only needle 204 defines any surfaces that cut bone during an insertion event. For example, with reference again to Figure 11A, in the illustrated embodiment, the obturator 104 is fully lowered in relation to the distal face 247 of the needle 204 and, thus, the obturator 104 does not cut the bone when the assembly 109 is rotated for drilling. Therefore, with reference again to Figure 10, a physical profile of the cutting edge 271 of only needle 204 can control or influence the softness of a force application profile for a puncture event. For example, in the illustrated embodiment, the physical profile of the cutting edge 271 is smooth and continuous as it passes from distal tip 246 (where the tangent T is substantially horizontal) proximally to the outer surface of the stem 250 (where the tangent T on both sides it is substantially vertical). A force profile of a force distally directed substantially along the longitudinal axis A _L can also be smooth, or to put it another way, it can be free of abrupt changes.
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50/82 [00116] For example, in some cases, an operator can use automatic trigger 108 for an insertion event. The operator can contact the bone with the distal tip 246 of needle 204 before activating automatic actuator 108. In actuation of actuator 108 and rotation of needle 204, the operator can apply force to actuator 108 which would tend to advance needle 204 distally through at least one outer surface of the bone. The force applied by the operator can be substantially constant, or it can move smoothly from a high amount to a low amount and / or from a low amount to a high amount throughout the drilling event due to the continuous nature of the cutting edge 271. For For example, because there are no discontinuities along the outer surface of needle 204 (as can happen, for example, with a transition from a needle cut surface to a plug cut surface), there may also be no discontinuous jumps in the amount of force that the operator applies during the drilling event.
[00117] With reference again to Figure 7, the needle tip 246 is formed in such a way that it is positioned in close proximity to the central longitudinal axis A _L of the needle 204. For example, in the illustrated embodiment, the needle tip 246 is positioned directly on the central longitudinal axis A _L. In other embodiments, the needle tip 246 can be moved laterally from the longitudinal axis A _L by a distance that is not more than 5, 10, 20 or 25 percent of a maximum lateral dimension (for example, maximum outside diameter) of needle 204.
[00118] In certain modalities, the distal end
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51/82
242 of needle 204 differs from some standard varieties of needles, such as Tuohy, Huber, or other needles with bent tips. Although such needles may include rounded regions and / or one or more beveled edges at their distal ends, similar to those discussed above, their distal tips are generally not very close to the central longitudinal axis. In certain embodiments, the distal end 242 of needle 204 also differs from other standard varieties of needles, such as standard IV needles, including lancet, single bevel, or other needles with unfolded tips. The distal ends of such needles, likewise, are generally not very close to the central longitudinal axis. Consequently, certain needles of this type can oscillate against a surface during rotation (for example, during drilling). Such oscillation can complicate drilling through hard bone structures, for example.
[00119] Furthermore, Huber, Tuohy, and / or other varieties of needles with bent tips become non-circular at the tip (for example, non-circular in cross section along a longitudinal axis that follows a curvature of a sidewall of the needle) during the forming operation, or otherwise have regions that extend laterally outward beyond the outer perimeter defined by a portion of the needle shank. In some cases, these deformed and / or enlarged regions can result in the formation of an access hole that is larger than the needle shank, which can result in the shank being loosely positioned within the hole.
[00120] With reference again to Figure 10, in
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52/82 some modalities, the distal face 247 can include a plurality of facets. For example, in some embodiments, lancet grinding can be applied to a pressure bevel to produce a lancet point. In certain of these modalities, the distal face 247 can include three facets, which, in some cases, can define three distinct planes. Any other arrangement suitable for the distal face 247 is contemplated.
[00121] As discussed earlier, however, the illustrated embodiment is particularly well suited for piercing the overlying skin tissue to reach the hard bone surface. In addition, the rotation of the illustrated needle 204 causes the needle cutting surface to penetrate through the hard bone into the marrow in extremely effective ways. Once access to the spinal cord is achieved, the obturator 104 can be removed to allow external communication between an interior of the bone structure and a suitable medical device or system (e.g., fluid line, syringe).
[00122] Figure 11A illustrates an initial phase of an illustrative method of using the intraosseous access system 100, and is a cross-sectional view of access assembly 109 in an assembled state. As discussed earlier, access set 109 includes plug assembly 102, guard 105, and needle set 202. In some cases, access set 109 will be pre-assembled, and thus can be removed from any sterile packaging substantially suitable in the configuration shown in Figure 11A. In some cases, cover 107 (see Figure 1) can first be removed from a
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53/82 distal end of assembly 102 to reach the illustrated configuration.
[00123] In the illustrated assembled state, the switched coupling interfaces 137, 210 of the plug hub 103 and the needle hub 203, respectively, can cooperate to ensure that a predetermined relationship between the plug 104 and the needle 204 is achieved. In other words, the switched coupling interfaces 137, 210 can ensure that the plug 104 sets a fixed angular orientation with respect to needle 204. The coupling interfaces 137, 210 can also maintain the fixed angular orientation during the rotation of the set of access 109 during an insertion, for example, during the rotation of the access set 109 through the automatic trigger 108.
[00124] In the illustrated embodiment, the distal face 147 of the obturator 104 is slightly lowered in relation to the distal face 247 of the needle 204. Additionally, in the illustrated embodiment, the distant faces 147, 247 of the obturator 104 and the needle 204, respectively, are substantially parallel to each other. In some embodiments, the obturator 104 does not cut through the skin or bone during an insertion event. In other embodiments, the distal faces 147, 247 can be substantially flush with each other. The plug 104 can substantially fill or otherwise block the passage to lumen 251 of needle 204. For example, in the embodiment illustrated, the distal face 147 of plug 104 is substantially the same size as an opening for a distal end of lumen 251 In various embodiments, an area of the distal face 147 of the obturator 104 is no greater than 5, 10, 15 or 20 percent less than an area
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54/82 defined by an inner edge of the distal face 247 of needle 204. The obturator 104 can inhibit or prevent tissue and / or bone material from entering and / or progressing in the lumen 251 of needle 204.
[00125] The inner surface 253 of needle 204 and an outer surface of plug 120 may be complementarily shaped and / or otherwise configured to prevent or inhibit the entry of tissue, bone and / or other matter. In other embodiments, an adjustment between the plug 120 and the needle 204 can allow the plug 120 to be easily removed from the needle 204. For example, a perfect fit, a loose fit, or a minimal gap between at least a portion between the plug 120 and the needle 204.
[00126] With continued reference to Figure 11 A, during the assembly of access set 109, the arms or profusions 132 of the plug hub 103 can be advanced over the skirt 228 of the needle hub 203. The plug-in interface or internal profusions 134 of the projections 132 can grasp a bottom side of the skirt 228 to keep the plug hub 103 and needle hub 203 in a coupled state. In the illustrated embodiment, skirt 228 is substantially shaped as an outward profusion, and the inner surface of arm 132 substantially defines a recess into which the profusion is received. In other embodiments, the protrusion / recess interface can be inverted. For example, arm 132 may define that a profusion that is received in a recess defined by skirt 228 to couple the plug hub 103 to the needle hub 203.
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55/82 [00127] The projection 132 and the skirt 228 can collectively be referred to as a release mechanism 262. The release mechanism 262 can be configured to keep the plug hub 103 and needle hub 203 coupled during the general handling of the access set 109, such as during packaging removal and / or coupling with the automatic actuator 108. The release mechanism 262 may, however, provide a relatively weak coupling that is capable of being released by application of sufficient removal force to the plug hub 103 in a proximal direction, relative to the needle hub 203. For example, the release mechanism 262 can provide a coupling force that tends to keep the plug hub 103 engaged in the needle hub 203. When a proximally oriented force on the plug hub 103 exceeds the coupling force of the releasable latch mechanism 262, the latch mechanism and releasable 262 can disengage and allow the plug hub 103 to be removed from the needle hub 203. In various embodiments, the coupling force (i.e., the force that counteracts a proximally directed force on the plug hub 103) cannot be greater than about 0.25, 0.5, 0.75, 1.0, 1.5 or 2.0 pounds.
[00128] In certain embodiments, the release mechanism 262 provides a coupling force that is significantly less than an embedding force between needle 204 and a bone into which needle 204 is inserted. In other words, the release mechanism 262 can be configured to allow the hub
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56/82 of obturator 103 is decoupled from needle hub 203, after needle hub 203 has been introduced into the bone, by transferring a force proximally directed to the obturator hub 103 which is less in magnitude than a force transmitted in the cannula 204 by the bone that holds the cannula 204 positioned in the bone.
[00129] Therefore, in some embodiments, after the introduction of the access set 109 into the bone, a user can simply pull back, or proximally, the plug hub 103 with any amount of force that exceeds the coupling force of the mechanism release latch 262, and the plug hub 103 will automatically disengage from needle hub 203. In addition, the plug hub 103 can be removed from needle hub 203 and the patient, and needle 204 can remain in the bone . In some cases, the user can remove the plug hub 103 from the needle hub 203 using a single hand after the access assembly 109 has been inserted into the bone. Other suitable arrangements of the release mechanism 262 are contemplated.
[00130] With continued reference to Figure 11A, when the access set 109 is in the assembled state, the guard 105 can be coupled with each of the plug 104 and the needle hub 204 in an unlocked state, in which the arms 162, 163 are deflected outwardly away from the longitudinal axis A _L _ _SYS . In particular, the proximal end 140 of the obturator 104, which can define a larger diameter than the recess 150, can extend across a whole of the shield 105. Put another way, the proximal end 140 of the obturator 104 extends through
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57/82 of side extensions 172, 173 and collar 160. As discussed further below, this region of larger diameter of plug 104 can keep guard 105 in the unlocked state to allow plug 104 to translate with respect to guard 105 in one proximal direction when the user wants to remove the plug hub 103 from the needle hub 204.
[00131] When the guard 105 is in the unlocked state, the arms are deflected outwards, which can seat or otherwise position the extrusions 178, 179 of the arms 162, 163, respectively, into the groove 227 of the needle hub 203. Outward extrusion 178, 179 can thus cooperate with groove 227 to hold guard 105 in a fixed longitudinal position with respect to needle hub 203 during the initial stages of removing plug 104 through guard 105. In other embodiments , the groove 227 and the outflows 178, 179 can be reversed. For example, in some embodiments, an inner surface of needle hub 203 may define one or more inward profusions, and arms 162, 163 may define inward recesses in which inward profusions are received when guard 105 is in the state unlocked (in relation to the plug 104) and in the coupled state in relation to the needle hub 203. The arms 181, 182 (not visible in Figure IA; see Figure 4) can also be kept in a deflected outward state in the illustrated configuration in Figure 11 A.
[00132] With continued reference to Figure 11A, when in the assembled state, which can also be referred to as
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58/82 a pre-use or perforation state, guard 105 defines a low profile configuration that is relatively close to the longitudinal axis A _L _ _SYS of the access set 109. the longitudinal axis A _L _ _SYS can also be referred to as a central axis or as an axis of rotation. That is, during the insertion of a distal end of the access set 109 into a patient's bone, the access set 109 can be rotated about the A _L _ _SYS axis. In many cases, the rotation can be very fast, such as when the access set 109 is coupled with the automatic trigger 108. In some cases, by defining a low profile configuration that is close to the axis of rotation, the protection 105 can have a low rotational moment of inertia that allows the guard 105 to rapidly rotate upward and / or allows the guard 105 to stop rotating rapidly as soon as the access assembly 109 is inserted into the bone. Protection 105 can also be relatively light, which can also contribute to a relatively low moment of rotational inertia.
[00133] Figure 11 B represents another stage of the illustrative method of using the intraosseous access system 100. Before the illustrated stage, the access set 109 can be coupled to an actuator 101, such as the automatic actuator 108. The set of access 109 - or more particularly, the distal ends of the needle 204 and the plug 104, in the coupled state - is advanced distally through the skin 304 of a patient 302 until the distal tip 246 of the needle 204 comes into contact with an external surface of a bone 306. As previously discussed, needle 204 may be particularly suitable
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59/82 to cut through the skin 304. In some cases, the access set 109 is advanced distally towards the bone 306 substantially without rotation. The distal end of needle 204 can thus cut and separate tissue from the skin when it comes in contact with bone 306. Upon contact with bone.
[00134] When making contact with bone 306, the operator can activate the automatic actuator 108 to quickly rotate the access set 109. In the illustrated mode, the access set 109 is rotated only clockwise, as seen from above. Consequently, only the highlighted portion of the cutting region 270 can contribute to cutting the bone 306. The operator applies distally directed force on the automatic actuator 108 and, therefore, on the access set 109, to advance the access set 109 through a layer rigid 307 of bone 306 and underlying marrow 308. In other methods, access set 109 can instead be rotated through skin 304 and then through hard bone 307. In any case, the operator can detect the from tactile feedback when access set 109 has advanced into bone 306, due to a sudden decrease in puncture resistance. The operator can then stop the actuation of the automatic actuator 108 and can decouple the automatic actuator 108 from the access set 109.
[00135] Figure 11 C represents a subsequent stage of the illustrative method, and shows a cross-sectional view of access set 109 after it has been used to provide access to the interior of bone 306. After the stage shown in Figure 11 C, The
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60/82 obturator assembly 102 can be removed from needle assembly 202. In the illustrated embodiment, obturator assembly 102 can be removed by pulling it in a proximal direction. The removal of the plug assembly 102 is described in more detail below in relation to Figures 11 D and 11 E.
[00136] Figure 11 D is an enlarged cross-sectional view of a portion of the access set 109 in a stage of the illustrative method that is subsequent to the stage shown in Figure 11 C. For clarity purposes, the shutter hub 103 does not is shown, although it was present in the view shown, when the plug hub 103 just started to be removed from the needle hub 203. In particular, in the illustrated stage, the plug assembly 102 is being uncoupled and removed from the needle assembly 202, as represented by the upward pointing arrow.
[00137] The guard 105 can remain in substantially the same orientation as that shown in Figures 11A and 11 C. In particular, the guard 105 can remain in the unlocked state due to the relatively large diameter of the plug portion 104 which is positioned within the openings 174 , 175 of arms 162, 163, respectively. In particular, the plug 104 may be large enough that portions of the side extensions 172, 173 that define the larger and substantially circular portions of the openings 174, 175 (see Figure 4) translate along the outer surface of the plug 104. Said otherwise, the shutter 104 may be small enough to slide or otherwise translate within the larger segments, substantially
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61/82 circular, of openings 174, 175, but it may be too large to fit into the substantially rectangular, constrained portions of openings 174, 175 (see Figure 4). Consequently, the inner surfaces of the side extensions 172, 173 that define the openings 174, 175 can press against the outer surface of the plug 104 to keep the arms 162, 163 in the deflected or displaced state. This outward deflection fixes the outflows 178, 179 into the groove 227 of the needle hub 203. The guard 105 thus remains attached to the needle hub 203.
[00138] The guard 105 can remain in the unlocked state when the plug 104 continues to be removed proximally due to the relatively large diameter of the plug 104, which can be substantially constant throughout the proximal length of the plug 104. The plug 104 can continue to keep the arms 162, 163 in the deflected or displaced state. This outward deflection fixes the outflows 178, 179 into the groove 227 of the needle hub 203. The guard 105 thus remains attached to the needle hub 203.
[00139] Figure 11 E is another enlarged cross-sectional view of access set 109 in a subsequent stage of the illustrative method, in which the plug 104 has been completely removed from the needle hub 203. Otherwise, the plug assembly 102 has been completely removed from needle assembly 202 and continues to be moved away from needle assembly 202, as represented by the upward arrow. Before the represented stage, the obturator 104 is removed proximally by
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62/82 an amount sufficient to bring recess 150 into the vicinity of openings 174, 175. Due to the reduced diameter of recess 150, the constricted portions of openings 174, 175 fit into recess 150 and the arms 162, 163 are thus allowed to transition automatically to their unpressed, deflected, or deformed state (or in other ways, this can be less depressed, less deflected, or less deformed). In other words, the arms 162, 163 can resiliently return to a less folded or unfolded state to automatically lock the guard 105 for the shutter 104.
[00140] When the guard 105 is in the locked state, portions of the lateral extensions 172, 173 that define the constricted portions of the openings 174, 175 enter the recess 150 to fix the protection 105 to the shutter 104. Likewise, in the illustrated mode, arm ends 181, 182 (see Figure 4) that were previously deflected outwardly by the larger stem of the plug 104 can deflect inwardly into the recess 150 as well. When guard 105 is blocked in shutter 104, the movement of guard 105 in relation to shutter 104 can be prevented or delimited in one or more directions (for example, longitudinally and / or rotationally). In some embodiments, the interference between the lateral extensions 172, 173 and the proximal and distal faces of the recess 150, respectively, can limit the longitudinal movement of the guard 105 in relation to the plug 104. In other cases, the ends of the arms 181, 182 (see Figure 4) that are also present with the recess 150
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63/82 can serve as a backup security measure, and can engage with a proximal face of recess 150 to maintain engagement between guard 105 and plug 104 if sufficient force is applied to guard 105 in a proximal direction, relative to to the plug, to dislodge the lateral extensions 172, 173 from recess 150. After dislodging the lateral extension 172, 173 from recess 150, and after a slight additional proximal movement of the guard 105, the proximal ends of the arms 181, 182 engage the face proximal to the recess 150 to prevent any further proximal movement of the guard 105 relative to the plug 104.
[00141] In the illustrated embodiment, when the arms 162, 163 automatically transition to the locked state in relation to the plug 104, the arms 162, 163 substantially simultaneously uncouple the protection from the needle hub 203. In particular, in the illustrated embodiment, the inward movement of the arms 162, 163 causes the outward profusions 162, 163 to come out of the groove 227 of the needle hub 203. This releases the guard 105 to move in relation to the needle hub 203, as for proximal movement in the longitudinal direction to exit the lumen 224. The guard 105 naturally remains in the blocked state in relation to the plug 104 and restricts access to the distal tip 146 of the plug 104.
[00142] Referring again to Figure 4, as discussed earlier, guard 105 may define a cage or casing 180 that substantially encompasses distal tip 146 of shutter 104 to restrict access to distal tip 146 when guard 105 is locked to the
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64/82 obturator 104. In the illustrated embodiment, collar 160 of guard 105 defines a fixed opening 167 at a distal end thereof. That is, a shape of opening 167 does not change when protection 105 transitions from the unlocked to the locked state. In a limited sense, distal tip 166 does not cover distal tip 146 of shutter 104, where distal tip 146 is visible through aperture 167. However, guard 105 can still be said to cover distal tip 146, at the as protection 105 is able to prevent inadvertent contact with distal tip 146. For example, opening 167 may be small enough to prevent a professional or other individual from inserting any portion of skin through opening 167 and for contact with the tip 146. In other embodiments, opening 167 may be smaller and / or may be configured to close when guard 105 transitions to the locked state. For example, in some embodiments, a cantilevered arm, valve, elastomeric septum, or other natural closure device can be positioned in opening 167.
[00143] Figures 12A and 12B represent elevation and perspective views, respectively, of another mode of a 401 driver. In the illustrated mode, the driver 401 is a manual driver 408 that can be used in place of the automatic driver 108 and, furthermore, it incorporates various components of the shutter assembly 102. In other embodiments, the manual actuator 408 can instead simply replace the automatic actuator 108 for example, a distal portion of the manual actuator 408 may include a connection interface, similar to that of
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65/82 connection interface 112 of automatic actuator 108, through which manual actuator 408 can connect directly to shutter assembly 102. In the illustrated embodiment, manual actuator 408 is configured to be coupled to needle assembly 202 and can be manipulated by one or more hands of a professional to insert needle 204 into a patient's bone.
[00144] The manual actuator 408 includes a handle 410 that can be lengthened in a longitudinal direction. Handle 410 may include any suitable gripping features 414, such as a plurality of horizontal grooves 412 that can improve the user's grip on handle 410. One
outer contour of handle 410 can have any proper ergonomic configuration.[00145] 0 408 manual override can include a pair coupling members 431 and an interface coupling 437 that resemble the members of
similarly numbered coupling 131 and coupling interface 137 described above. These characteristics can work in the same way to couple the manual actuator 408 to the needle assembly 202. Similarly, the manual actuator 408 can include a plug 404, like the plug 104.
[00146] Manual actuator 408 can be coupled to needle assembly 202, and can be used to provide intraosseous access. The illustrated embodiment can cut the bone when rotated in any direction around the longitudinal axis. In some cases, a professional can press down against a proximal end of handle 410 and can rotate handle 410 back and forth
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66/82 to insert the needle into the bone.
[00147] Figure 13 schematically illustrates another modality of an intraosseous access system 500 that resembles system 100 in many aspects. System 500 includes a needle assembly 502 having a needle 504 that is fixedly attached to a connector 506. System 500 further includes a plug assembly 512 that includes a plug 514 fixedly attached to a connector 516. Sets 502, 512 are represented in a coupled state. The sets 502, 512 are coupled through a connection interface 520. The connector 516 defines a T-shaped grip 530 or handle that can be used to manually manipulate the system 500 to obtain intraosseous access.
[00148] The connection interface 520 can be of any suitable variety. As further discussed below, in some embodiments, connection interface 520 may still be used to connect needle 504 to any suitable medical interface after the plug assembly 512 has been removed. For example, interface 520 can be configured as a Luer fitting, which can be attached to an external piping (for example, an IV line), suction equipment and / or other medical devices after the 512 plug assembly has been removed. In other embodiments, connection interface 520 can be used to connect to obturator assembly 512 and an additional or separate connection interface can be used to connect (for example, subsequent connection) to one or more medical devices using intraosseous access provided by needle set 502. Still in
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67/82 In other embodiments, the connection interface 520 can be used to connect to one or more medical devices, while the additional connection interface is used to connect to the plug assembly 512.
[00149] Connector 516 is fixedly attached to a proximal end of plug 514. Connector 516 can be configured to selectively couple with connector 506 of needle assembly 502, as previously described. For example, in some embodiments, connection interface 520 of connector 506 may comprise a Luer fitting, and connector 516 of plug 512 may comprise a complementary Luer fitting (not shown) configured to mate therewith. Any connection interface suitable for coupling connectors 506, 516 is contemplated.
[00150] In the illustrated embodiment, when the needle set 502 and the plug set 512 are in a coupled state, the plug 514 extends through connector 506 and through a lumen of needle 504. In certain embodiments, since the intraosseous access has been established, needle set 502 can remain in bone, while connector 516 can be detached from connector 506, and plug set 512 can be removed from needle set 502. Any suitable configuration for connector 516 that allow the manual application of sufficient translational and / or rotational forces to the coupled sets 502, 512 to penetrate hard bone tissue is contemplated.
[00151] Figure 14 represents another modality of an intraosseous access system 600 that can resemble the intraosseous access systems described above in
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68/82 certain aspects. The system 600 can be identical to the system 500, with the exception that a connector 616 of the same can be formed as a hand punch handle 630 which can be used to manually manipulate the system 600 to obtain intraosseous access, instead of a configuration T-shaped. Any suitable configuration of connector 616 is contemplated.
[00152] Any suitable method can be employed to form needles, such as those described above. By extension, such methods can form a subset of the processes used to manufacture any of the access sets and / or intraosseous access systems described herein. In some embodiments, a needle is formed from a cylindrical tube. The tube is bent in order to maintain a circular transverse perimeter, or cross section, along a complete central axis thereof, where the central axis follows the curve of the tube in ways as discussed above. A distal face (e.g., distal face 247) of the distal tip can be formed by any suitable technique, such as grinding.
[00153] In other or additional modalities, the forming process ensures that the distal end (for example, distal end 242) of the needle has one or more of the properties previously discussed, such as a lateral cross section that does not extend transversely outwardly to in addition to a lateral cross section or perimeter defined by the stem portion extending proximally from the distal end of the needle. For example, in some embodiments, the outer surface of the tube from which
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69/82 the needle is formed is restricted in at least the region in which the fold is made during manufacture. The restraint can be provided by any suitable mounting structure, such as a fixture (see, for example, fixture 800 shown in Figure 16).
[00154] In some methods, fixation is used to bend a tube from which the needle is formed before grinding, and then the needle tip is ground at a later stage. In other methods, fixation is used after the needle tip has been formed by grinding. In various embodiments, the distal end of the needle is formed in such a way that the diameter of the orifice or hole formed by the distal end of the needle during an access event is equal to or less than the outer diameter of the stem. In other words, a perimeter of the orifice or hole formed by the distal end of the needle may be equal to or less than the transverse perimeter of the stem.
[00155] Figures 15A-15E describe various steps in an illustrative method of forming a needle, such as needle 204 discussed above. By extension, the illustrative method can form a subset of the processes used to manufacture, for example, the access set 109.
[00156] Referring to Figure 15A, at an early stage of the process, a supply of piping stock is cut to length to produce a 700 tube. In some cases, the stock piping is initially wound so as to have a curvature. Therefore, in some embodiments, the tube 700 is straightened, either before
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70/82 or after being cut to length. Tube 700 can be substantially cylindrical after straightening. In other words, each of an inner surface and an outer surface of the tube 700 can be substantially cylindrical. The tube 700 can define a longitudinal axis A _L, and a transverse section circumference of the tube 700 can be substantially circular.
[00157] With reference to Figure 15B, at another stage of the process, a distal end of the tube 700 can be bent by a desired amount. Bending tube 700 can produce a stem 702, which can remain substantially cylindrical, and a bent region 704 that extends distally from stem 702. Bent region 704 can be formed by sufficient deflection of tube 700 so that the region folded 704 of the tube intersects the longitudinal axis AL.
[00158] Referring to Figure 15C, at another stage of the process, a portion of the folded region 704 may be ground or otherwise removed to form a distal face 720. The distal face 720 may correspond to the distal face 247 of the discussed needle 204 above. In some cases, the distal face 720 can be formed as a simple pressure grinding. Grinding the distal end of the tube 700 can produce a more distal point 725 of the tube. For example, before folding (Figure 15A), a distal end of tube 700 can end on one face, such as a flat ring. After folding (Figure 15B), the most distal portion of tube 700 may instead end at a more distal point 723. However, at this stage, the most distal point 723 is not directly on the longitudinal axis
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71/82
A _L. After grinding (Figure 15C), tube 700 may terminate at a more distal point other than 725 which is now on the longitudinal axis A _L.
[00159] With reference to Figure 15D, the bending of the tube 700 can cause at least a portion of the bent region 704 to define a substantially oval profile. The profile may be a tube of cross-section 700 along a plane that is orthogonal to a central axis Ac through tube 700. In Figure 15C, the central axis Ac is aligned with the longitudinal axis AL along the stem 702, and also in the cross section plane of Figure 15D. In some cases, the central axis Ac can be curved so that it is centered within the folded region 704, as shown in Figure 15B.
[00160] With continued reference to Figure 15D, the oval profile can be elongated in a first dimension that is substantially orthogonal to the central axis Ac. In the illustrated configuration, the first dimension is the horizontal dimension.
[00161] With reference to Figure 15E, at another stage of the illustrative method, a compressive force, or compressive forces, can be applied to the bent region 704 of the tube 704 along the first dimension, thus driving the bent region 704 inward. towards the central axis Ac. The compressive forces are schematically represented as inwardly directed arrows. Any suitable instruments or machines can be used to apply the force. For example, in some embodiments, forces can be applied by a lathe or another device. The vise can be marked in such a way that the vise is tightened to a predetermined width to make
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72/82 at least a portion of the circular folded region 704 (as in Figure 15F). In some cases, the compressive forces are applied to the bent region 704 in order to narrow the cross section profile of the bent region 704 along the first dimension, while elongating the bent region 704 along a second dimension that is orthogonal to both the first dimension and central axis Ac. In the illustrated embodiment, the folded region 704 is elongated in the vertical dimension, and narrowed in the horizontal dimension.
[00162] With reference to Figure 15F, in another stage of the illustrative method, the compressive forces can be removed or from the folded region 704. In other words, in some cases, the folded region 704 can be released. In some cases, releasing folded region 704 may allow folded region 704 to recover naturally to a less ovalized orientation, which may be substantially circular in some cases. After the removal of the compression forces, a total of the folded region 704 can be circumscribed by, surrounded by, or otherwise fitted within an imaginary projection PROJ (Figure 15C) of the external cylindrical surface of the stem 702. The imaginary projection can be considered as the original position of the folded region 704, before the fold, or can be considered as a continuation of the cylindrical surface that remains centered along the longitudinal axis AL. In other words, after compression has been applied, no portion of the distal region 704 extends transversely outward beyond the imaginary projection of the external cylindrical surface of the stem 702.
[00163] Various stages of the illustrative method that
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73/82 just described can be performed in different orders and / or can be performed simultaneously with other stages. For example, in some cases, the bending stage can be performed simultaneously with the compression stage. In some cases, grinding may occur before folding. Other changes to the illustrative method are contemplated.
[00164] Some methods of forming a obturator, such as the obturator 104 discussed above, may be the same or substantially the same as the illustrative methods discussed in relation to the formation of the needle
204. Instead in use a tube, However, methods can use a stick or thread. [00165] THE Figure 16 is a perspective view of an fixation 800 what can be used to form a
distal end of a needle, or a plug, such that its distal end exhibits one or more of the properties described above. In the illustrated embodiment, the fixture 800 includes a base 810 and a forming plunger 820. The base 810 includes a body 812 having a plunger recess 813, a plunger hole 814 and a needle bore 816 formed therein. Needle bore 816 defines a central longitudinal axis A _F. The plunger 820 includes a body 822 and a press 824. A distal end of the press 824 defines a molding surface 826.
[00166] In certain examples of needle-forming procedures, a distal end of a tube (for example, a tube formed of stainless steel) is ground in any suitable manner. For example, in some methods, an angled tip can be formed using a
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74/82 simple pressure grinding (for example, by any means known for such grinding). In other methods or additional methods, one or more lancet grinders can be applied in forming the tip. The tube may initially end on a flat face. Grinding the tube can provide the tube with a distal tip or, to put it another way, a distal end of the tube can reach a more distal point.
[00167] An outer diameter of the tube can be substantially the same or just slightly less than an inner diameter of the 816 needle diameter. Thus, the tube can be easily inserted and removed from the 816 needle hole. In addition, the hole needle 816 can restrict the tube during tip formation, thereby preventing a distal end of the tube from taking on a shape that has a transverse perimeter that is larger than a cross section of a more proximal portion of the tube or otherwise extends to outside said cross section of the proximal portion of the tube (for example, it has a maximum width that exceeds the diameter of the proximal portion).
[00168] In some procedures, plunger 820 is retracted to ensure that the distal end of needle hole 816 is unobstructed. Plunger 820 can be retracted within plunger recess 813 (for example, partially retracted) or can be completely retracted from plunger recess 813 (for example, completely retracted).
[00169] The angled end of the tube is then inserted into the needle hole 816 with the angled surface of the tube facing downwards (in the illustrated orientation), or indicated otherwise
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75/82 mode, in a direction away from the plunger bore 814. The plunger 820 is then pressed down as far as possible in the position shown in Figure 16. In this final position, the most distal point of the molding surface 826 of the plunger 820 is approximately aligned with the central longitudinal axis A _F of the needle hole 816. The central longitudinal axis A _L of the needle (see Figures 6) thus formed is substantially collinear with the central longitudinal axis A _F of the needle hole 816. Consequently, after molding the distal end of the ground tube, the resulting needle tip is in close proximity to the central longitudinal axis Ax of the needle. The needle can then be removed from needle hole 816.
[00170] The body 812 of the base 810 can be formed from any suitable material. The material can be hard enough to resist deformation and instead retain its shape and give the distal end of the needle the same shape during a tip-shaping procedure.
[00171] Certain modalities described here can advantageously reduce heating during automated drilling. Other modalities or additional modalities can make drilling procedures smoother and more consistent, which can contribute to safety and / or ease of use considerations. For example, in some cases, instead of starting a drilling procedure by turning a sharp point against the bone, and then eventually engaging the cutting surfaces of the drilling device, a consistent cutting area
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76/82 can be applied and the amount of that cutting area in use at any time can increase smoothly to a maximum.
[00172] The term patient is widely used here and is not intended to be limiting. A patient can be, for example, any individual who undergoes any of the methods or treatments discussed here, whether in a hospital, first aid, or other situation. The term patient includes humans, mammals or any other animal that has anatomy compatible with the modalities described herein.
[00173] Any methods disclosed herein comprise one or more steps or actions to carry out the described method. The steps and / or actions of the method can be interchanged with each other. In other words, unless a specific order of steps or actions is necessary for the proper operation of the modality, the order and / or the use of specific steps and / or actions can be modified.
[00174] As used in this specification and the appended claims, the singular forms one, one and o include plural referents, unless the context clearly indicates otherwise. Thus, for example, the reference to a layer includes a plurality of such layers.
[00175] In this disclosure, you understand, understanding, containing and having and the like may have the meaning assigned to them in US patent law and may mean includes, including and the like and are generally interpreted as open terms. The
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77/82 terms first, second, third, fourth and the like in the description and in the claims, if any, are used to distinguish between similar elements and not necessarily to describe a particular sequential or chronological order. It is to be understood that the terms thus used are interchangeable in appropriate circumstances, such that the modalities described herein are, for example, capable of operating in sequences other than those illustrated or otherwise described herein. Likewise, if a method is described here as comprising a series of steps, the order of such steps as presented here is not necessarily the only order in which such steps can be performed, and some of the steps indicated can possibly be omitted and / or some other steps not described here can possibly be added to the method.
[00176] The terms left, right, front, back, top, bottom, top, bottom and the like in the description and in the claims, if any, are used for descriptive purposes and not necessarily to describe permanent relative positions. It is to be understood that the terms thus used are interchangeable in appropriate circumstances, in such a way that the modalities described herein are, for example, capable of functioning in orientations other than those illustrated or otherwise described herein. The term coupled, as used here, is defined as connected directly or indirectly in any suitable manner. The objects described here as adjacent to each other may be in physical contact with each other, close to each other, or in the same region
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78/82 or general area than each other, as appropriate to the context in which the phrase is used.
[00177] As used here, the term substantially refers to the extent or complete or almost complete degree of an action, characteristic, property, state, structure, item or result. For example, an object that is substantially closed would mean that the object is completely closed or almost completely closed. The exact degree of deviation allowed from absolute completeness may, in some cases, depend on the specific context. However, in general, the proximity of the conclusion will be such as to have the same general result, as if the absolute and total conclusion had been obtained. The use of substantially is equally applicable when used in a negative connotation to refer to the complete or almost complete lack of an action, characteristic, property, state, structure, item or result. For example, a composition that is substantially free of particles would either be completely devoid of particles, or almost completely without particles so that the effect would be the same as if the particles were completely missing. In other words, a composition that is substantially free of an ingredient or element can still contain that item, as long as there is no measurable effect.
[00178] As used here, the term about is used to provide flexibility to a numerical range endpoint by providing that a given value can be just above or just below the endpoint. In addition, for references to approximations (which are made throughout this specification), such as using the terms
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79/82 about or approximately, or other terms, it should be understood that, in some modalities, the value, resource, or characteristic can be specified without approximation. For example, when qualifiers are used such as, substantially and generally, these terms include in their scope qualified words in the absence of their qualifiers. For example, where the term substantially perpendicular is recited in relation to a resource, it is understood that in other modalities, the resource may have a precisely perpendicular orientation.
[00179] As used here, a plurality of items, structural elements, composition elements and / or materials can be presented in a common list for convenience. However, these lists must be interpreted as if each member of the list was identified individually as a separate and exclusive member. Thus, no individual member of such a list should be interpreted as a de facto equivalent of any other member of the same list solely on the basis of its presentation in a common group without indication to the contrary.
[00180] Concentrations, quantities and other numerical data can be expressed or presented here in an interval format. It should be understood that such a range format is used merely for convenience and brevity and therefore should be interpreted flexibly to include not only the numerical values explicitly recited as the limits of the range, but also include all individual numeric values or subintervals encompassed within that range, as if
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80/82 each numeric and sub-range value was explicitly recited. As an illustration, a numerical range of about 1 to about 5 should be interpreted to include not only the values explicitly recited from about 1 to about 5, but also include individual values and subintervals within the indicated range. Thus, included in this numeric range are individual values such as 2, 3 and 4 and subintervals, such as 1-3, 2-4 and 3-5, etc., as well as 1, 2, 3, 4 and 5, individually.
[00181] This same principle applies to intervals that recite only a numerical value as a minimum or maximum. In addition, such an interpretation must be applied regardless of the breadth of the interval or the characteristics described.
[00182] References throughout this specification for an example, if any, means that a particular feature, structure or feature described in connection with the example is included in at least one modality. Thus, the appearances of phrases in an example at various locations throughout this specification are not necessarily all referring to the same modality.
[00183] Reference throughout this specification to a modality or modality means that a particular feature, structure or feature described in connection with that modality is included in at least one modality. Thus, the phrases quoted, or variations thereof, as quoted throughout this specification, are not necessarily all referring to the same modality.
[00184] Likewise, it should be appreciated that in the description above of modalities, several resources are, for
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81/82 times, grouped in a single modality, figure, or description of them with the purpose of rationalizing the disclosure. This method of disclosure, however, should not be interpreted as reflecting the intention that any claim will require more resources than those expressly cited in that claim. On the contrary, as the claims that follow reflect, the inventive aspects are found in a combination of less than all the resources of any of the modalities described above.
[00185] Claims after this written disclosure are hereby expressly incorporated into this written declaration, with each claim standing on its own as a separate modality. This disclosure includes all permutations of the independent claims with their dependent claims. In addition, additional modalities capable of deriving from the independent and dependent claims that follow are also expressly incorporated into the present written description. These additional modalities are determined by replacing the dependency on a given dependent claim with the phrase any of the preceding claims up to and including claim [x], where the term in brackets [x] is replaced by the most recently recited independent claim number. For example, for the first set of claims that begins with independent claim 1, claim 3 may depend on any one of claims 1 and 2, with these separate dependencies producing two distinct modalities; claim 4 may depend on
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82/82 any one of claims 1, 2 or 3, with these separate facilities producing three distinct embodiments; claim 5 can depend on any one of claims 1, 2, 3 or 4, with these separate dependencies producing four distinct embodiments; and so on.
[00186] Recitation in the claims of the first term in relation to a resource or element does not necessarily imply the existence of a second or additional such resource or element. Elements specifically recited in the half-plus-function format, if any, must be interpreted in accordance with 35 U.S.C. § 112 (f). Elements not presented in the half-plus-function format should not be interpreted in accordance with 35 U.S.C. § 112 (f). Modalities of the invention in which an exclusive property or privilege is claimed are defined as follows.

权利要求:
Claims (10)
[1]
1. Intraosseous access system FEATURED by the fact that it comprises:
a needle that defines a lumen and a longitudinal axis around which the needle is configured to be rotated
to cut on a bone of a patient, the needle comprising: an far end proximal configured for stay in an outdoor of the patient during the use;
a distal end configured for insertion through the patient's skin in contact with the patient's bone; and a distal tip at a more distal point from the distal end of the needle, the distal tip being positioned on the longitudinal axis of the needle; and a obturator sized to be received within the needle lumen and configured to prevent material from entering the needle as the system is inserted into said bone.
[2]
2. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that the needle further comprises a stem that extends proximally from the distal end of the needle, the stem defining a lateral perimeter along a plane that is perpendicular to the longitudinal axis, and in which no portion of the distal end of the needle is laterally spaced from the longitudinal stem of the needle by an amount exceeding a distance between the lateral perimeter of the stem and the longitudinal axis.
[3]
3. Intraosseous access system, according to the
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2/10 claim 1, CHARACTERIZED by the fact that the needle further comprises a stem extending proximally from the distal end of the needle, the stem defining a cylindrical outer surface, and in which no portion of the distal end of the needle extends laterally outward in addition to an imaginary projection of the outer cylindrical surface that passes over the distal end of the needle.
[4]
4. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that:
the needle comprises an inner wall that defines the lumen;
the needle further defines an opening at the distal end of the lumen; and a cross-sectional area of the lumen in each plane that is proximal to the opening and which contacts the inner wall at right angles to it varies by no more than 50 percent of a maximum cross-sectional area of the lumen.
[5]
5. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that:
the needle comprises an inner wall that defines the lumen;
the needle further defines an opening at the distal end of the lumen; and a cross section of the lumen in each plane which is proximal to the opening and which contacts the inner wall at right angles to it is substantially circular.
[6]
6. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that the distal end of the needle comprises a cutting edge
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Rounded 3/10 that extends from a first side of the needle to a second side of the needle that is opposite the first side, and where a slope of a tangent to the cutting edge transits continuously from the first side of the needle to the second side of the needle.
[7]
7. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that the distal end of the needle comprises a cutting edge comprising the distal tip of the needle, and in which a line tangent to the cutting edge at the tip distal is perpendicular to the longitudinal axis of the needle.
[8]
8. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that the needle defines a cut surface at a distal end of the same and in which the distal end of the obturator is either flush with or lowered in relation to the cutting surface, so as not to contribute to any cutting of the patient's bone when the needle is turned.
[9]
9. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that a needle cutting surface comprises a single pressure grinding.
10. Systemclaim intraosseous access, infact wake upin withwhat TheThe 1, CHARACTERIZED fur surface ofgrinding cutting the lancet needle. comprises one or more 11. System intraosseous access, in wake up with The claim 1, CHARACTERIZED fur fact in what The
distal end comprises a flat surface that extends proximally from the distal point and is at a
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4/10 angle to the longitudinal axis.
12. Intraosseous access system, according to claim 11, CHARACTERIZED by the fact that the angle is not greater than 15 degrees.
13. Intraosseous access system, according to claim 11, CHARACTERIZED by the fact that the distal end further comprises a rounded region that extends away from the flat surface.
14. Intraosseous access system, according to claim 13, CHARACTERIZED by the fact that the obturator comprises a rounded region and a flat surface, and in which the rounded regions and the flat surfaces, respectively, of the obturator and the needle are align when the plug is attached to the needle.
15. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that it also comprises a safety guard configured to automatically lock at a distal end of the obturator when the obturator is removed from the needle lumen for
prevent contact inadvertent with a distal tip of shutter. 16. System of intraosseous access, according The claim 15, CHARACTERIZED BY fact that O
shutter define a groove configured to receive a portion of the security guard to prevent or inhibit the longitudinal movement of the security guard in relation to the shutter when the security guard locks in the shutter.
17. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that the needle is
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5/10 attached to a Luer fitting.
18. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that the needle is attached to a connector that allows connection with the external tubing.
19. Intraosseous access system, according to claim 1, CHARACTERIZED by the fact that the plug is attached to a connector configured to couple the system to a drive device.
20. Intraosseous access system, according to claim 19, CHARACTERIZED by the fact that the needle is attached to an additional connector, and in which the connectors are configured to selectively attach to and separate from each other.
21. Intraosseous access system according to claim 20, CHARACTERIZED by the fact that the connectors are switched to ensure that the needle and plug maintain a fixed angular orientation in relation to each other when the connectors are attached to each other .
22. Intraosseous access system, according to claim 19, CHARACTERIZED by the fact that the drive device comprises an automatic drill.
23. Intraosseous access system, according to claim 19, CHARACTERIZED by the fact that the actuation device comprises a manual actuator.
24. Intraosseous access system according to claim 1, CHARACTERIZED by the fact that the distal end of the needle comprises one or more cutting regions that are configured to allow the needle to cut the bone when the needle is rotated in a first
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6/10 direction or a second direction that is opposite the first direction.
25. Method to achieve intraosseous access, the method CHARACTERIZED by the fact that it comprises:
advancing a distal end of an intraosseous access system comprising a needle and a plug through a patient's skin until a distal tip at a more distal point on the needle comes into contact with a patient's bone, the needle defining a lumen within of which the obturator is positioned and still defining a longitudinal axis, the distal tip of the needle being positioned on the longitudinal axis of the needle;
rotating the intraosseous access system to cut into the patient's bone and to insert the intraosseous access system into the bone; and inhibiting, through the obturator, material from entering the needle when the intraosseous access system is inserted into the bone.
26. Method according to claim 25, CHARACTERIZED by the fact that the needle defines a cutting surface at a distal end thereof and in which a distal end of the obturator is either leveled with or lowered in relation to the cutting surface through all of said rotation so as not to contribute to said cutting of the patient's bone.
27. Method, according to claim 25, CHARACTERIZED by the fact that it further comprises:
removing the plug from the needle lumen; and automatically lock a security guard at a distal end of the shutter when the shutter is
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7/10 removed from the needle lumen to prevent inadvertent contact with a distal end of the obturator.
28. Method according to claim 27, CHARACTERIZED by the fact that said automatic locking of the security guard comprises allowing a portion of the security guard to be received in a groove defined by the plug to prevent or inhibit the longitudinal movement of the guard safety in relation to the shutter.
29. Method, according to claim 25, CHARACTERIZED by the fact that the plug is attached to a connector, the method further comprising coupling the intraosseous access system to a drive device through the connector.
30. Method, according to claim 29, CHARACTERIZED by the fact that the drive device comprises an automatic drill, and in which said rotation of the intraosseous access system is achieved through the automatic drill.
Method, according to claim 29, CHARACTERIZED by the fact that the actuation device comprises a manual actuator, and in which said rotation of the intraosseous access system is achieved through the manual manipulation of the manual actuator.
32. Method according to claim 25, CHARACTERIZED by the fact that the distal end of the needle comprises one or more regions of cut, and wherein said rotation of the intraosseous access system comprises rotating the needle in a first direction to cut bone like that and rotate the needle in a second direction that is opposite
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8/10 to the first direction to cut the bone like that.
33. Method for forming a needle, the method CHARACTERIZED by the fact that it comprises:
folding a tube that defines a longitudinal axis to provide the tube with a folded region that intersects the longitudinal axis;
grinding the tube in such a way that a point further from the folded region is positioned on the longitudinal axis;
shaping at least a portion of the folded region such that the at least one outer perimeter of the folded region across a plane that is orthogonal to a central axis through the tube is substantially circular.
34. Method, according to claim 33, CHARACTERIZED by the fact that said tube bend elongates a perimeter of the region bent in a first dimension, and wherein said molding comprises:
compressing at least a portion of the folded region towards the longitudinal axis in the first dimension, so as to elongate the perimeter of the folded region in a second dimension that is orthogonal to the first dimension; and releasing said at least a portion of the folded region.
35. Method, according to claim 34, CHARACTERIZED by the fact that said compression is achieved via a lathe.
36. Method according to claim 33, CHARACTERIZED by the fact that the tube comprises a substantially cylindrical rod region adjacent to the folded region after said tube fold, and
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9/10 wherein, after said release of said at least a portion of the folded region, no portion of the folded region extends transversely outward beyond an imaginary projection of an external surface of the stem region that passes over the folded region.
37. Method for forming an intraosseous access device, the method CHARACTERIZED by the fact that it comprises:
forming the needle according to the method according to claim 33, wherein the needle defines a lumen and a distal opening; and forming a plug sized to fit within the needle lumen without extending through the distal needle opening.
38. Method for forming a needle, the method CHARACTERIZED by the fact that it comprises:
grinding a tube, of which at least a portion defines an external cylindrical surface, to form a more distal point of the tube; and mold a distal end of the tube such that the most distal point is aligned with a longitudinal axis that passes through a center of the cylindrical tube and such that no portion of the distal end extends transversely outward beyond an imaginary projection of the outer cylindrical surface.
39. Method according to claim 38, CHARACTERIZED by the fact that said molding of the distal end of the tube comprises:
bend a part of the tube;
compress, after said fold, the portion of the tube
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[10]
10/10 inwards towards the longitudinal axis; and releasing, after said compression, the portion of the tube to allow the tube to move naturally out of the longitudinal axis.
40. Method according to claim 38, CHARACTERIZED by the fact that said molding of the distal end of the tube comprises deflection of the most distal point of the tube while restraining the tube within a fixation.
41. Method for forming an intraosseous access device, the CARACTERI Z ADO method because it comprises:
forming the needle according to the method according to claim 38, wherein the needle defines a lumen and a distal opening; and forming a plug sized to fit within the needle lumen without extending through the distal needle opening.

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AU2017345349A1|2019-04-18|

引用文献:

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CN113520512A|2020-04-21|2021-10-22|巴德阿克塞斯系统股份有限公司|Reusable push-to-actuate intraosseous access device|

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CN113749723A|2020-06-02|2021-12-07|巴德阿克塞斯系统股份有限公司|Intraosseous device and data transmission|

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CN215606058U|2020-06-03|2022-01-25|巴德阿克塞斯系统股份有限公司|Obturator assembly configured for use with an intraosseous access system|

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CN113940727A|2020-07-17|2022-01-18|巴德阿克塞斯系统股份有限公司|Safety mechanism|

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CN114098918A|2020-08-25|2022-03-01|巴德阿克塞斯系统股份有限公司|Angled intraosseous access system|

法律状态:
2021-10-05| B350| Update of information on the portal [chapter 15.35 patent gazette]|

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2022-02-15| B06W| Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]|

优先权:

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申请号 | 申请日 | 专利标题

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US201662409825P| true| 2016-10-18|2016-10-18|

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US201762600857P| true| 2017-03-07|2017-03-07|

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US201762525663P| true| 2017-06-27|2017-06-27|

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PCT/US2017/057270|WO2018075694A1|2016-10-18|2017-10-18|Intraosseous access devices, systems, and methods|

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