• 专利附录
  • 专利说明
  • 权利要求
  • 类似技术
  • 同族专利
  • 引用文献
  • 法律状态
  • 优先权
    • 专利摘要:
    a tool to insert a catheter into a patient's body is provided. the tool comprises: a housing, in which at least a portion of the catheter is initially arranged; a needle extending distally from the housing, at least a portion of the catheter arranged over the needle; a guide wire initially disposed inside the needle partially; and an advance set for advancing the catheter distally. the housing comprises: a first portion comprising a distal part and a proximal part; and a second portion engaged with the first portion, wherein the distal portion of the first portion is configured to be able to slide distally from the second portion to release the engagement between the first portion and the second portion. the advance assembly includes a safety cap which is initially arranged over the needle and is configured to be locked into the housing by distally sliding to a position to isolate the needle tip within the safety cap.
    公开号:BR112019018016A2
    申请号:R112019018016
    申请日:2017-03-01
    公开日:2020-04-28
    发明作者:Huang Heqing；Chen Jianjiang；Khuen Adrian Chan Weng
    申请人:Bard Inc C R；
    IPC主号:
    专利说明:

    CATHETER INSERT DEVICE
    TECHNICAL FIELD [001] The present invention relates to medical devices, more particularly, a catheter insertion device for inserting a catheter into a patient's body.
    BRIEF SUMMARY [002] Modalities of the present invention are directed to an insertion tool for insertion of a catheter or other tubular medical device into a patient's body. The insertion tool in one mode integrates needle insertion, guide wire advancement, a needle extending distally from the housing and the insertion of the catheter in a single device to provide one. catheter implantation procedure.
    [00.3] In one embodiment, the catheter insertion tool of the present invention comprises a housing, a sliding safety cap along the needle, wherein the safety cap is configured to be locked into the housing when sliding distally to a position of needle tip insulation inside the safety cap.
    [004] In one embodiment, the safety cap includes a first portion involving the needle and a second portion of a sliding form attached to a rail, the rail being an integral part or fixed to the housing. In an alternative embodiment, the catheter insertion tool further comprises a catheter hub that is connected to the safety cap until the safety cap is locked in the housing when moving distally to the insulating position of the needle tip.
    Petition 870190084587, of 08/29/2019, p. 5/102 [005] In one embodiment, the housing of the catheter insertion tool of the present invention comprises a
    first portion comprising a distal portion and : a part proximal, and a second portion engaged with the first portion, where the distal part of the first portion is configured to be able to slide distally across èt relation
    second portion to release the engagement between the first portion and the second portion.
    [006] In an alternative embodiment, the proximal part of the first portion of the housing is attached to the second portion. In an alternative embodiment, a hook is arranged on an internal surface of the distal part of the first portion,
    the hook having a tip extending in direction to proximal end of the housing, and a slot is
    arranged in the second housing portion, where the groove receives the hook when the first portion and the second portion
    are engaged, and the hook is released from of the slot when the distal part of the first portion is slid distally in such a way that the first portion is is released
    of the second portion.
    [007] In an alternative embodiment, in which the proximal end of the distal part of the first portion of the housing is configured to be axially blocked for
    the second portion of the housing, and the distant from first portion is configured to be able to Slide distally from the second portion when the block
    between the proximal end of the distal part of the first
    portion and the second portion is released so as to release the
    engage between the first portion and the second portion. In an alternative embodiment, the proximal end of the
    Petition 870190084587, of 08/29/2019, p. 6/102 distal from the first portion is flexible and pressed toward the second portion when the proximal end of the distal portion of the first portion is axially blocked to the second portion. In an alternative embodiment, the proximal end of the distal part of the first portion is pressed towards the second portion by a slider, and where when the slider is moved distally to a certain position, the proximal end of the distal part of the first portion is not pressed and the lock between the proximal end of the distal part of the first portion and the second portion is released.
    [008] In an alternative embodiment, a first protrusion extends from the proximal end of the distal part. towards the second portion of the housing, and a second protrusion extends from the second portion in. towards the proximal end of the distal part of the first portion of the housing, and when the proximal end of the distal part of the first portion is pressed in the direction of the second portion and the first protrusion is proximal to the second protrusion, the proximal end of the distal part of the the first portion is axially blocked for the second portion.
    [009] In one embodiment, a septum for a catheter insertion tool of the present invention comprises a cylindrical main body and a first protrusion that extends from a central portion of a top surface of the main body.
    [0010] In an alternative embodiment, the septum of the present invention further includes a slit formed within the septum along the longitudinal axis of the septum.
    Petition 870190084587, of 08/29/2019, p. 7/102
    Alternatively, the crack is formed within the first protrusion. Alternatively, the slit extends through the septum. Alternatively, the slit is enlarged when a needle extends through the slit and is closed when the needle is removed from the septum. Alternatively, the outer diameter of the main body of the septum is greater than the inner diameter of a lumen of the catheter insertion tool before the septum is installed in the lumen. In an alternative embodiment, the septum of the present invention further includes a second protrusion extending from a central portion of a bottom surface of the main body opposite to the top surface.
    [0011] In one embodiment, a septum for a catheter insertion tool of the present invention comprises a circular end portion and a tubular portion extending from the periphery of the circular end portion. In an alternative embodiment, the septum of the present invention further includes a protrusion extending from a central portion of a surface of the circular end portion opposite the tubular portion. Alternatively, a slit is formed within the end portion. Alternatively, the crack is formed within the protrusion. Alternatively, the slot extends through the end portion. Alternatively, the slit is enlarged when a needle extends through the slit and is closed when the needle is removed.
    [0012] In one embodiment, a guide wire advancement device for a catheter insertion tool of the present invention, comprising: a push block, including an orifice extending through the block of
    Petition 870190084587, of 08/29/2019, p. 8/102
    5/43 pushing from a top surface to a bottom surface of the push block, wherein a first side wall of the hole is in the form of a flat curve; and a rail including a groove aligned with the hole in the longitudinal direction of the catheter insertion tool. In an alternative embodiment, the orifice has a second side wall opposite the first side wall is straight, the minimum distance between the first and second side walls is wide enough to allow free longitudinal movement of a guide wire and is sufficiently narrow to restrict the wire oscillation [0013] In an alternative embodiment, the guide wire advance device further comprises an anchoring point for which an end of one. guide wire is fixed, and the guide wire proximally extends from the anchor point, enters the hole through a first rail potion, extends away from the hole and distally extends to a second portion of the rail.
    [0014] In one embodiment, a guide wire advance device for a catheter insertion tool of the present invention comprises a wheel and a rack configured to rotate the wheel such that a guide wire is driven around the wheel. Alternatively, the guide wire advance device further comprises a gear fixed coaxially to the wheel, the rack including teeth for engaging the gear. Alternatively, the guide wire advance device further comprises at least one tensioner for restraining the guide wire against the peripheral surface of the wheel. Alternatively, the wire feed device
    Petition 870190084587, of 08/29/2019, p. 9/102
    The guide 6/43 further comprises a tube rail to guide the movement of the guide wire.
    [0 015] In a modality, the tool the of inse jrção of price exempt invention dog understands an accommodation the in what fur any less a portion of catheter is i .initially dispc > s t a, an needle extending dií staly to j iartir do alc ) j amer ito, fur any less a portion of disp catheter osta about needle, it is a
    advancing assembly for distally advancing the catheter, wherein the housing comprises a first portion comprising a distal portion and a proximal portion and a second portion engaged with the first portion, wherein the distal portion of the first portion is configured to be able to slide distally in with respect to the second portion to release the engagement between the first portion and the second portion, and where the advance assembly includes a safety cap which is initially disposed on the needle and is configured to be locked in the housing when sliding distally to a position to isolate the needle tip inside the safety cap. In an alternative embodiment, the engagement of the first and second portions of the housing is released in preparation to slide the safety cap to the position that isolates the needle tip within the safety cap.
    [0016] These and other modalities features of the present invention will become more evident from the following description and appended claims, or can be learned by practicing modalities of the invention as set out below.
    BRIEF DESCRIPTION OF THE DRAWINGS [0017] A more detailed description of this
    Petition 870190084587, of 08/29/2019, p. 10/102
    7/43 disclosure will be made by reference to its specific modalities which are illustrated in the attached drawings. It is appreciated that these drawings represent only typical embodiments of the invention and, therefore, should not be considered as limiting their scope. Examples of embodiments of the invention will be described and explained with specificity and additional detail using the attached drawings, in which:
    [0018] Figure 1 is a perspective view of an insertion tool according to an embodiment of the present invention;
    [0019] Figure 2 is a top view of the cross section of the insertion tool of Figure 1;
    [0020] Figures 3 A and 3 B there are several views exploded of the tool < the insertion of Figure 1 and Figure 2; [0021] Figures 4A-4C is 5 lateral zistas of one hello there of the tool insertion steel catheter rdo with a mod purpose of the present invention: HO f[0022] Figure 4D shows the inner surface of hello there of Figures 4 A- -4C; [0023] The figures 5A-5C are side views of one accommodation of the tool insertion steel catheter rdo with a mod pre ality: feels invention;[0024] The figures 5D-5F most viewed multiple views of accommodation of Figures 5 A- -5C; [0025] The figures 6 A and 6B mo £ stram multiple views gives
    internal structure of the insertion tool according to an embodiment of the present invention;
    [0026] Figure 6C shows the structure of a cover
    Petition 870190084587, of 08/29/2019, p. 11/102 security of insertion tool in accordance with an embodiment of the present invention;
    [0027] Figures 7A and 7B show the engagement between a catheter hub and a safety cap of the insertion tool according to an embodiment of the present invention;
    [0028] Figure 8A is a top view of the cross section of a security cover and an insertion tool rail according to an embodiment of the present invention;
    [0029] Figure 8B is a partially enlarged view of Figure 8A;
    [0030] Figure 8C is a cross-sectional view of the safety cover of Figures 8A and 8B;
    [0031] Figure 9 shows septa arranged in the insertion tool according to an embodiment of the present invention;
    [0032] Figures 10A-10OD show various views of a septum according to an embodiment of the present invention;
    [0033] The figures 11A and 11B most r am multiple views of a septum according with one, the mc > dal age of this invention; [0034] The figures 12 A and 12 B mo s t r am multiple views of an advance set in fi the gu went according to a modality of the present invention; [0035] The figures 13A- 13C mos walk various ias views from a pusher guide wire in 3.CC irdo with one modality of the present invention;[0036] The figures 14 A and 14 B show multiple views
    of a guide wire feed assembly according to an embodiment of the present invention.
    Petition 870190084587, of 08/29/2019, p. 10/122
    9/43 ιίι Φδτ nana πϊγ madst TnaniíC! cttt τγπτακγδγϊδ ^
    S „J Pa is 1 ^ .4 ^, - 1- L ..JMlV, .8. K i iriwiJM JUJEí -8- LJ ^ xL / £ L · k OJ J Jlj -L [0037] I will now refer to L figures in which similar structures will be provided with similar reference designations. It is understood that the drawings are schematic and diagrammatic representations of exemplary modalities of the present invention, and are neither limiting nor necessarily drawn to scale.
    [0038] For clarity, it should be understood that the
    word proximal if refers to a relative direction : nte closest to a c. Linico using device a to be described here while the word dist al refers to an direction r e1at i v amente further from the clinician. Per example, the edge of a catheter willing inside of body of a patient is considered a distal end of the catheter r while the end of the c remain remains ; ndo
    outside the body is a proximal end of the catheter. In addition, the words including, has and having as used herein, including the claims, shall have the same meaning as the word comprising. Unless specifically stated otherwise, the word initially refers to the state of the insertion tool of this invention when it is still in the assembled state as delivered to a health care institution such as a hospital or clinic (or a patient for use by the patient himself or the patient's personal care assistant) and has not been operated or used. Unless specifically stated otherwise, axially or axially refers to the longitudinal direction of the insertion tool, which is also the orientation of the needle.
    Petition 870190084587, of 08/29/2019, p. 13/102 [0039] Modalities of the present invention are generally directed to an instrument to assist with the placement in a patient of a catheter or other tubular medical device. For example, catheters of various lengths are typically placed in a patient's body in order to establish access to the patient's vasculature and allow the infusion of medications or the aspiration of body fluids. The catheter insertion tool to be described herein facilitates such catheter placement. Note that, while the discussion below focuses on the placement of a catheter of a particular type and relatively striking length, catheters of a variety of types, sizes and lengths can be inserted through the present device, including peripheral or extended IV catheters. , PICC's, central venous catheters, etc. In one embodiment, catheters of any length are possible.
    [0040] Reference is first made to Figure 1 and Figure 2, which describe various details of a catheter insertion tool (also referred to in the insertion tool below), usually represented in 10, according to one modality. As shown in Figure 1, which is the perspective view of the insertion tool, the insertion tool 10 includes a housing 12 which in turn includes a first portion 12A and a second portion 12B.
    [0041] In one embodiment, the first portion 12A of the housing 12 is engaged separately with a second portion 12B of the housing 12. In one embodiment, the first portion 12A is capable of being distally sliding with respect to
    Petition 870190084587, of 08/29/2019, p. 14/102 to the second portion 12B to release the engagement. Details about the coupling and release will be provided later.
    [0042] Figure 2 is a top view of the cross section of the insertion tool. In one embodiment, as shown in Figure 2, the insertion tool 10 includes a rail 14 that is an integral part of housing 12 or is an independent element, but attached to housing 12. For example, rail 14 can be an integral part of the first portion 12A (as shown in Figure 1) of the housing 12 or the second portion 12B of the housing 12, or can be attached to the housing 12 by molding or assembly.
    [0043] The insertion tool 10 further includes a handle 16 for a clinician to stably hold the tool 10 during operation of the tool. In one embodiment, the handle 16 extends from the rail 14. In. other embodiments, the handle 16 extends from the housing 12, FEATURE I in that the handle is arranged in the first portion 12A or the second portion 12B of the housing 12. In one embodiment, a surface of the handle 16 includes small protrusions so increase friction. In another embodiment, the surface of the handle 16 includes other structures that can increase friction, for example, grooves, bends, matte surface and so on.
    Such protrusions or similar structures on the surfaces of the handle 16 improve operational stability when the user, such as a physician, operates the insertion tool.
    [0044] Figure 3A and Figure 3B are several exploded views of the insertion tool 10 of Figure 1 and the
    Figure 2. Reference is now made to Figure 3A, in which a needle hub 18A that supports a hollow needle 18 is placed
    Petition 870190084587, of 08/29/2019, p. 15/102 between housing portions 12A and 12B. Needle 18 extends distally from needle hub 18A through the body of the insertion tool 10 and out of a distal end of housing 12. In another embodiment, needle 18 is at least partially hollow while still allowing functionality here described. In one embodiment, a notch 18B is defined through the wall of the needle 18 near its distal end. The notch 18B allows the flashback of blood to exit the lumen defined by the hollow needle 18 when access to the patient's vasculature is achieved during catheter insertion procedures. Thus, blood coming out of notch 18B can be seen by a clinician to confirm that the needle is properly inserted into the vasculature.
    [0045] As shown in Figures 2 and 3B,
    tool insertion 10 i also includes a set in ca advance teter 20 to advance distally ui n catheter 22 inside of the vasculature of the patient. THE extremity in proximal to catheter 2 2 is attached. ada to a cube of catheter 2 4.
    Both catheter 22 and catheter hub 24 are initially arranged on needle 18. And at least a portion of catheter 22 and catheter hub 24 are pre-arranged within housing 12. In one embodiment, a distal portion of catheter 22 extends to outside the distal end of the housing 12. In one embodiment, the catheter hub 24 includes a handle extending out of the housing 12 from a groove 12C in the housing, and the handle of the catheter hub 24 can be used to advance of catheter 22 and catheter hub 24. Slot 12C exists between the first portion 12A and the second
    Petition 870190084587, of 08/29/2019, p. 16/102 portion 12B of housing 12, allowing movement of the catheter hub 24. In another embodiment, the catheter hub 24 handle is a branch tube 24A extending from the catheter hub 24. In another embodiment, sterile protection is provided for the branch tube.
    [0046] The reference is continued to Figures 2 and 3B, where the insertion tool 10 includes a safety cap 26. Safety cap 26 is initially attached to the catheter hub 24, and can be separated from the catheter hub 24 when it is slid to a certain position. In one embodiment, the safety cap 26 is locked in the housing 12 when sliding into position. Details on this locking mechanism should be described below.
    [0047] In one embodiment, the safety cap 26 includes a first portion 26Ά involving the needle and a second portion 26B slidably attached to the rail 14. In one embodiment, the position where the catheter hub 24 and the safety cap 26 can be separated is a position where the needle tip 18 is insulated within the first portion 26A of the safety cap 26. In one embodiment, the second portion 26B of the safety cap 26 is locked on the rail 14 when the safety cap 26 slide to
    position that tip of needle 18 is isolated inside the first portion 26A da t ampa of secure 2 2. 0 blocking between the cover security 26 (more spec icically Monday portion 26B) and the rail 14 i . prevents the movement relative in between cap security 7 6 and 18 needle, avoiding reexposure the tip the needle and eliminating so the possibility of the needle perf u rar a cl .inico or the
    Petition 870190084587, of 08/29/2019, p. 17/102 patient.
    [0048] With reference to Figure 3B, in one embodiment, the insertion tool 10 also includes at least one septum 28 to prevent exposure to blood, while the needle and catheter are inserted or removed from the patient's body. There may be one or multiple septa placed within the insertion tool 10. In one embodiment, a septum 28 (not shown in Figure 3B) is disposed within the lumen of the catheter hub 24. In one embodiment, a septum 28 is disposed in the first portion 26A of the safety cap 26. In one embodiment, a septum 28 is disposed within the lumen of the first portion 26A of the safety cap 26. To be noticed, a septum can also be disposed within another element of the insertion tool, for example. example, the catheter cube branching tube 24. The size and shape of a septum are configured to fit the corresponding element or a lumen of the element, and when multiple septa are used, the size and shape of each septa can be be the same or different.
    [0049] Referring again to Figure 3A, in one embodiment, the insertion tool 10 comprises a guide wire advance set 30 to distally advance a guide wire 32 or remove it from the patient's vasculature. In one embodiment, the guide wire advance assembly 30 further includes a pusher 34 to operate the movement of the guide wire 32 in preparation for advancing the catheter 22.
    [0050] In one embodiment, at least a portion of the guide wire 32 is disposed within the lumen of the needle 18. In an alternative embodiment, the distal end of the guide wire 32
    Petition 870190084587, of 08/29/2019, p. 18/102 is initially discarded inside the tip of the needle 18, while the other end of the guide wire 32 is attached to an anchor point in the housing 12 or the rail 14. The guide wire 32 extends proximally from the anchorage point, enters into an orifice 36 disposed in pusher 34 and is bent through orifice 36, extends away from orifice 36 and distally extends to the lumen of needle 18. In one embodiment, the movement of pusher 34 applies a frictional force to the bent portion of the guide wire 32 in order to advance or retract the distal portion of guide wire 32. When pusher 34 is moved distally, guide wire 32 is distally advanced twice the movable distance from pusher 34. This conveniently increases the efficiency of the guide wire advance, which is desired in the operation of such a medical device.
    Housing [0051] Figure 4 A and Figure 4 B are side views of a housing 40 of the catheter insertion tool of the present invention. The housing 40 includes a first portion 42 comprising a distal portion 42A and a proximal portion 42B, and a second portion 44 engaged with the first portion 42, FEATURE that the distal portion 42A of the first portion 42 is configured to be able to slide distally in with respect to the second portion 44 to release the engagement 46 between the first portion 42 and the second portion44.
    [0052] In one embodiment, the proximal part 42B of the first portion 42 is attached to the second portion 44. Alternatively, the proximal part 42B of the first portion 42 is engaged with the second portion 44 through a
    Petition 870190084587, of 08/29/2019, p. 19/102 separable configuration, for example, a snap joint, a pin joint, rivet joint, buckle and so on. A force above the threshold magnitude is required to release the separable engagement between the proximal part 42B of the first portion 42 and the second portion 44, in order to prevent accidental separation of the housing. In another embodiment, the proximal part 42B of the first portion 42 and the second portion 44 are inseparable from each other or form an integrated part.
    [0053] In one embodiment, as shown in Figure 4C and Figure 4D, a hook 46A is arranged on an internal surface of the distal part 42A of the first portion 42 of the housing. The hook 46A has a tip extending to the proximal end of the housing 40. A groove 46B is placed in the second portion 44. The groove 46B receives the hook 46A when the first portion 42 and the second portion 44 are engaged, and the hook 46A is released from the groove 46B when the distal portion 42A of the first portion 42 is slid distally such that the first portion 42 is released from the second portion 44.
    [0054] Referring again to Figure 4A, the first portion 42 and the second portion 44 of the housing 40 are engaged with each other through the engagement 46 formed by the hook 46A and groove 46B and the engagement between the proximal part 42b of the first portion 42 and the second portion 44. In the direction indicated by the arrow, the distal portion 42A of the first portion 42 can be slidable distally from the second portion 44 of housing 40. The distal sliding of the distal portion 42A of the first portion 42 results in the distal movement of the hook 46A with respect to hole 46B. When the
    Petition 870190084587, of 08/29/2019, p. 10/202
    46A reaches the position as shown in
    Figure 4B, the hook 46A can be separated from the hole 46B, such that the latch 46 is released and the distal part
    42A of the first portion 42 and the second portion 44 can be separated in a direction perpendicular to each other.
    [00b5] To be noted, while Figures 4A - 4D show only a pair of hook 46A and hole 46B, in one embodiment, the housing 40 of the present invention includes two hooks and two holes. In order to better stabilize the coupling 46, as an optimal modality, two hooks are arranged in parallel on the inner surface of the distal part 42A and, correspondingly, two holes are arranged in the second portion 44 in the same way as the two hooks. Other numbers and arrangement of hooks and holes are possible and within the spirit of the present invention.
    [0056] As shown in Figures 4A and 4B, in one embodiment, a base 48 is disposed on an internal surface of the second portion 44 of the structure 40 to hold the proximal end of a needle 18. The proximal end of needle 18 is fixed in the accommodation. In one embodiment, the base 48 includes an orifice allowing the guidewire to extend into the lumen of the needle 18 through the orifice.
    [0057]
    As shown in Figure
    4D, in one embodiment, a slot
    4b is arranged on an interior surface of at least one of the first and second portions
    42/44, the groove 45 having an interior width that is wide enough to allow free movement of the catheter in an axial direction and narrow enough to
    Petition 870190084587, of 08/29/2019, p. 21/102 restrict the movement of the catheter perpendicular to the axial direction. That is, the first and second portions of the housing, when engaged with each other, provide support for the distal portion of needle 18, which limits the oscillation of needle 18, while needle 18 is being inserted or removed from a patient's body.
    [0058] In one embodiment, the distal part 42A and the proximal part 42B are always connected to each other before or after distal movement of the distal part 42A. The connection can be formed by an elastic, folding or articulated connection. Examples of an elastic or collapsible connection may be a hinge, spring or other flexible part.
    [0059] In another embodiment, the portion 42A distal from the first portion 42 can be separated from the second portion 44 after the distal portion is distally slid to release the engagement between the first portion 42 and the second portion 44.
    [0060] Continuously referring to Figures 4A-4D. In another embodiment, the proximal end of the distal portion 42A of the first portion 42 includes a structure 49 that is fixed between the proximal portion 42B of the first portion 42 and the second portion 44, the movement of the structure 49 being limited within a cavity formed by the proximal part 42B of the first portion 42 and the second portion 44. Specifically, in one embodiment, the structure 49 includes a flexible sheet 49A extending proximally from the proximal end of the distal part 42A, and two walls 49B extending vertically from two sides of the end portion of flexible sheet 49A. In one embodiment, after the distal part 42A is distally
    Petition 870190084587, of 08/29/2019, p. 22/102 slid over a certain distance, the structure 49 is blocked by the base 48 in order to prevent further distal movement of the distal part 42A of the first portion 42. A certain distance is also the distal movement distance of the hook 46A that allows that hook 46A is released from hole 46.
    [0061] In one embodiment, the leaf 49A and the two walls 49b of the structure 49 of the distal part 42A engage with a ridge extending from the base 48. The ridge acts as a rail for the structure 49, which allows for a distal movement along the ridge, but also restricts the oscillation of structure 49 during distal movement.
    [0062] In one embodiment, the structure 49 is secured by the base 48 of the second portion 44 and the internal surface of the proximal part 42B of the first portion 42. This prevents the distal part. 42A to be separated from the rest of the housing, and allows the open-close movement of the distal part 42A with respect to the second portion 44 at an angle. Such a mechanism prevents the housing form from falling apart after use, which is good for medical safety (for example, prevention
    sting in needle and / or coi ntamination by blood) and experience of user. [0063]Figures 5A-5C are ; not seen sides of one accommodation 50 the tool insertion catheter gives
    present invention. As shown in Figure 5A, the housing 50 includes a first portion 52, comprising a distal portion 52A and a proximal portion similar to the proximal portion 42B shown in Figures 4A and 4B, and a second portion 54 engaged with the first portion 52. The end proximal 56 of the distal part 52A of the first portion 52 is configured
    Petition 870190084587, of 08/29/2019, p. 23/102 to be able to be axially locked to the second portion 54, and the distal part 52A of the first portion 52 is configured to be distally slidable with respect to the second portion 54 when the lock between the proximal end 56 of the distal part 52A of the first
    portion 52 and the second portion 54 is released, in so the release the hitch 46 en tre the first portion 52 Θ cl Monday portion 54.[0064] To be continued to be done r « reference to Figi ura 5A,
    where in one embodiment, as shown in the partially enlarged view “K, a first protrusion 56A extends from the proximal end 56 of the distal part 52A towards the second portion 54, and a second protrusion 56B extends from the second portion 54 in the direction from the proximal end 56 of the distal part 52A of the first portion 52. In Figure 5A, the proximal end 56 of the distal part 52A of the first portion 52 is flexible and is pressed (by a slide 58 for example) to the second portion 54, and the the first protrusion 56A is proximal to the second protrusion 56B, where the proximal end 56 of the distal part 52A of the first portion 52 is axially locked to the second portion 54, such that the first portion 52 cannot be moved axially and distally in relation to the second portion 54.
    [0065] Figure 5B is the side view of the distal part 52A of the first portion 52 of the housing shown in Figure 5A. The proximal end 56 of the distal part 52A shown in Figure 5B is a natural, unpressed state, which is in the form of a chamfer tilting slightly upward proximally. The chamfer can have a thickness
    Petition 870190084587, of 08/29/2019, p. 24/102 consistent. Alternatively, the chamfer thickness may gradually increase or decrease distally, with the smallest or largest thickness achieved at the site of the first protrusion
    56A (without considering the height of the first protrusion 56A itself). The chamfer having such a varied thickness can help to change the amount of twist that the slide 58 imposes on the chamfer and the friction between the slide 58 and the chamfer.
    [0066] Figure 5C is the side view of the housing when the block between the proximal end of the distal part
    52A of the first portion 52 and the second portion is released. In one embodiment, when the sliding cover 58 is moved distally, the force that the slider 58 imposes on the proximal end 56 of the distal part 52A of the first portion 52 decreases and the proximal end 56 is grouped unimpressed, and consequently , the first protrusion 56A moves upwards relative to the second protrusion 56B. When the slide 58 is distally moved to a certain position, as shown in Figure 5C, the first protrusion 56A moves to reach a position where the second protrusion 56B no longer blocks the distal movement of the first profusion 56A and thus the blockage between the proximal end 56 of the distal part 52A of the first portion 52 and the second portion 54 is released.
    [0067] Similar to housing 40 in Figures 4A
    4D, in an embodiment as shown in Figures 5D and 5E, a hook 46A is disposed on an internal surface of the distal part 52A of the first portion 52 of the housing 50, and a groove 46B is disposed on the second portion 54 of the housing 50, in a position corresponding to hook 46A.
    Petition 870190084587, of 08/29/2019, p. 25/102 hook 46Α can be in a shape of first perpendicularly projecting from the inner surface of the distal part 52A of the first portion 52 of the housing 50 and then extending horizontally and proximally, as shown in Figure 5F. The slot 46B receives the hook 46A when the first portion 52 and the second portion 54 are engaged, and the hook 46A is released from the slot 46B when the lock between the proximal end 56 of the distal part 52A of the first portion 52 and the second portion 54 is released and the distal part 52A of the first portion 52 is slidable distally, such that the first portion 52 can be released from the second portion 54.
    [0068] Figure 5F is the side view of the insertion tool showing the state in which the engagement between the distal part 52Ά of the first portion 52 and the second portion 54 is released. In one embodiment, the proximal end 56 of the distal part 52A of the first portion 52 includes a structure of 56C, which is secured between the proximal part (not shown in Figure 5F) of the first portion 52 and the second portion 54 and the movement of the structure 56C is bounded within a cavity formed by the proximal part of the first portion 52 and the second portion 54. Specifically, in one embodiment, structure 56C is similar to structure 49 as shown in Figures 4A -C. In one embodiment, after the distal part 52A is slid distally over a certain distance, the structure 56C is blocked by the base 48 in order to prevent further distal movement of the distal part 52A of the first portion 52, CHARACTERIΖΑΡΑ by the fact that that said certain distance is also the distance of the distal movement of the hook 46A that allows the hook
    Petition 870190084587, of 08/29/2019, p. 10/26
    46A is released from slot 46B.
    [0069] Such a locking mechanism between the proximal end 56 of the distal part 52A of the first portion 52 and the second portion 54 can effectively prevent the inadvertent operation of a clinician which can cause distal movement of the distal part of the first portion of the housing and thus preventing unwanted separation from the housing. In addition, in one embodiment, in addition to releasing the axial lock between the distal part 52A of the first portion 52 and the second portion 54, the distal movement of the slide 58 is also configured to advance the guide wire at the same time, and such a configuration increases operational efficiency and safety.
    Έ3 £ & S '* 23 ‘F 23 Fí 23
    XT Xez ^ 3 »ve & xS * .F ** · *, · XX vX. ^ 3» ^ 3X vX ιΧ— XX K3IL [0070] Figure 2 and Figure 6A show the internal structure of an insert tool modality 10 of the present invention. Specifically, Figure 2 is a top view of the insertion tool 10 without the first portion 12A of the housing 12. In one embodiment, the insertion tool 10 of the present invention includes a housing 12, a rail 14 attached to the housing, a needle 18 extending distally from housing 12, a catheter advance assembly 20, a guide wire advance assembly 30, wherein the catheter advance assembly 20 includes a catheter 22, a catheter hub 24, and a safety cap 26 that is separated to be attached to the catheter hub 24.
    [0071] In addition to the state shown in Figure 2, Figure 6A shows the safety cover 26 distally sliding to a position where the safety cover 26 is locked to the rail 14. In one embodiment, the cover
    Petition 870190084587, of 08/29/2019, p. Security 27/102 26 is configured to be locked to housing 12 when sliding distally to an insulating position of the needle tip 18 within safety cover 26. It should be noted, as rail 14 can be a part of the housing or is attached to the housing, when the safety cover 26 is locked to the rail 14, the safety cover 26 can also be considered to be locked to the housing 12. Figure 6A clearly shows the position that the safety cover 26 is in locked in the housing and the needle tip is isolated inside the safety cap 26. In this position, the movement
    relevant between cap security 26 and The needle 18 is restricted so the avoid re-exposure to the tip of needle. [0072] A Figure 6B shows the view what ie the cube of
    catheter 24 is separated from the safety cap 26, when the safety cap 26 is in position, as described in Figure 6A.
    [0073] As shown in Figures 6A and 6B, in one embodiment, the safety cap 26 is locked to the housing 12 at a location 60 and the tip 18C of the needle 18 is isolated inside the safety cap 26, when the safety cap 26 slides into position to isolate the needle tip 18C inside the safety cap.
    [0074] Figure 6C shows the structure of the safety cover 26 of an embodiment of the present invention. The safety cap 26 includes a first portion 26 A and a second portion 26B. Seen in combination with Figures 2, 6A and 6B, in one embodiment, the first portion 26A of the safety cap 26 surrounds the needle 18 and the second portion 26B
    Petition 870190084587, of 08/29/2019, p. 28/102 of the safety cap 26 is slidably attached to a rail 14. Specifically, in one embodiment, the first portion 26A of the safety cap 26 includes a lumen 27 extending through the first portion 26A, which contains and wraps the needle 18.
    [0075] In one embodiment, the first portion 26A of the safety cap 26 has two fingers 62. In one embodiment, the two fingers 62 have a slot between them surrounding the needle 18. In another embodiment, three, four or even more fingers are possible. In another embodiment, fingers 62 are in the form of a strip or column.
    [0076] Figures 7A and 7B show the engagement between the
    catheter hub 2 4 and the cover safety 2 6 of a pr mode esent . and i n convention. 0 hitch is formed by insert a prot rusãc ! 6 4 on fingers 6 2 in one recess 66 placed in the cube from ca .teti 2 4. [0077] Co: m r « measure to the Figure 7ê í, in a modality, the fingers 5 6 2 are con figured To be
    pressed radially towards a surface
    internal cube of catheter 24 when the rod of needle 18 stretches through: first s portion 26A cover, safety. 2 6. This is when the first portion 26A of cover security : to 26 in zolve a hast> and needle, the 62 fingers are
    slightly skewed / pressed outwards by needle 18. Fingers radially pressed 62 insert> protrusion 64 into recess 66, and pressure from needle 18 helps to hold protrusion 64 into recess 66, thereby engaging between the catheter hub 24
    Θ cl safety cover 26.
    [0078] With reference to Figure 7B, in a
    Petition 870190084587, of 08/29/2019, p. 29/102 modality, fingers 62 are configured to be released from the pressed position when the safety cap 24 distally slides to the position of isolating the tip of the needle 18. That is, when losing pressure from the needle, the fingers 62 converge towards the lumen axis of the catheter hub 24, and the protrusion 64 can be pulled out of the recess 66 and thus the catheter hub 24 can be separated from the safety cap 26.
    [0079] With reference to Figure 7A, in one embodiment, the fingers 62 are configured to remain in the same position when the needle stem extends through the first portion 26A of the safety cap 26 and when the safety cap 26 slides distally to the insulating position of the needle tip. That is, the fingers 62 are held in the same position and are basically not pressed, with or without pressure from the needle 18. And the outer diameter of the hollow cylinder formed by the fingers does not change if the needle extends through the hollow cylinder or not. However, the pressure of the needle 18 facilitates the insertion between the protrusion 64 and the recess 66.
    [0080] Referring to Figure 7B, in one embodiment, when losing pressure from the needle, fingers 62 are held in the same skewed position / pressed by needle 18. In this situation, when a user of the insertion tool tries to pull the safety cap 26 away from the catheter hub 24, the protrusion 64 is removed from the recess 66.
    [0081] In one embodiment, each of the fingers 62 includes a protrusion 64, and a corresponding number of recesses 66 are arranged on the inner surface of the cube
    Petition 870190084587, of 08/29/2019, p. 30/102 catheter. In one embodiment, each of the fingers 62 may include one or more protrusions 64.
    [0082] Now reference is made to Figure 6C. The proximal side of the protrusion 64 forms an obtuse angle with respect to the surface of the finger 62, where the proximal side extends from the finger 62. That is, the proximal side of the protrusion 64 is a slope that allows the protrusion 64 to be pulled towards out from recess 66 when fingers 62 are not skewed / pressed by needle 18.
    [0083] With reference to Figures 8A-C, the second portion 26B of the safety cover 26 is a lever 81, which slides along the rail 14. In one embodiment, the lever 81 includes two vertical walls 82 vertically extending from on both sides of a surface 84 of lever 81 facing rail 14. Each of the two vertical walls 82 has. a horizontal part with a protrusion 86, that protrusion is blocked within a notch 88 formed on the rail 14, in order to block the safety cover 26 for the housing 12 when the safety cover 26 slides distally to the isolation position of the needle tip 18 into safety cap 26.
    [0084] To clearly describe the structure of lever 81, reference is made to Figure 8C, which is a sectional view of a plane perpendicular to the lumen axis of the safety cap 26. In one embodiment, the surface 84 of the lever facing the rail 14 includes two vertical walls 82, and the lever 81 is connected to the first portion 26A of the security cover 26 on the opposite side of the surface 84. Each of the two vertical walls 82 has a part
    Petition 870190084587, of 08/29/2019, p. 31/102 horizontal with a protrusion 86. Here, the horizontal part is
    basically parallel to the surface 84 is at a modality, the walls λ zertices 82 extend per all the length gives lever, and the horizontal part is more short than O length the total lever. In another modality, at
    vertical walls 82 extend only about a partial length of the lever, and the horizontal part is shorter than the length of the vertical walls 82.
    [0085] As shown in Figure 8B, in one embodiment, the notch 88 is formed between two prominent projections 88A and 88B arranged on the rail. In another embodiment, the proximal projection 88A has an inclined slope 88C on the proximal side and is substantially vertical with respect to the rail surface on the distal side.
    In. one embodiment, the distal overhang 88B is raised higher from the surface of the rail 14 than the proximal overhang
    88A. While protrusions 86 slide over the inclined slope 88C of the proximal overhang
    88A, the distance between the two protrusions of the lever increases along the inclined slope 88C and the tension between the two protrusions also gradually increases.
    When protrusions 86 fall into the notch formed by the prominent projections 88A and 88B, additional movement of the protrusions is blocked by the proximal side of the prominent projection
    88B and the distal side of the prominent protrusion 88A, and thus the safety cap 26 is locked on the rail 14.
    [0086] In one embodiment, a user of the insertion tool (for example, a clinician) feels a tactile sensation when the safety cap 26 is locked into housing 12, for example when the protrusions 86 of the
    Petition 870190084587, of 08/29/2019, p. 32/102 lever fall into slot 88. In one mode, an audible sound is produced in addition to the tactile sensation.
    Septum [0087] Referring to Figure 9, in one embodiment, the insertion tool includes at least one septum 90 to prevent exposure to blood while the needle is inserted and the catheter is advanced into or away from the patient's body. In one embodiment, the septum 90 can be arranged in a lumen within the insertion tool. For example, the septum 90 can be placed in a lumen of the catheter hub 24 of the insertion tool and / or can be placed in a lumen of the safety cap 26 of the insertion tool.
    [0088] In one embodiment, a septc > 9 0 is willing inside the lumen of the catheter hub 2 4 . In an mc > age, one. septum 100 is laid out on the first pc > ration 2 6Ά gives cover security 26 In one embodiment, a magnet septum 110 is willing
    inside the lumen of the first portion 26A of the safety cap 26. To be noticed, the septum can also be placed in another element of the insertion tool, for example, the branch tube of the catheter hub 24. The size and shape of the septum 26 are configured to fit the corresponding element or lumen of the element, and the size and shape of each septa can be the same or different.
    [0089] Figures 10 A-D show a septum 90 of an embodiment of the present invention. Referring to Figure 10A, in one embodiment, the septum 90 comprises a cylindrical main body 92, and a first protrusion 94 extending from a central portion of a top surface 94A
    Petition 870190084587, of 08/29/2019, p. 33/102 of the main body 92. In one embodiment, the thickness of the cylindrical main body 92 is configured to be less than the distance between the tip and the notch of the needle 18, in order to reduce the friction between the septum 90 and the needle 18.
    [0090] As shown in Figure 10B, the septum 90 has a slit 96 formed within the septum 90 along the longitudinal axis of the septum. In one embodiment, the slot 96 is formed within the first protrusion. In one embodiment, slit 96 extends through the septum. Specifically, the slot 96 can extend partially or entirely through the cylindrical main body 92 and the protrusion. In one embodiment, the slit 96 is enlarged when a needle 18 extends through it and is closed when the needle 18 is removed from the septum 90. When the needle pierces the entire septum, the slit 96 consequently extends through the septum. As a preferred embodiment, to ensure septum sealing performance 90, slit 96 is initially not through the entire thickness of septum 90, and so when the needle pierces septum 90 during the assembly process, septum 90 will wrap tightly the needle and provide a tight seal around the needle. As another embodiment, the septum 90 is formed without a slit, and when the needle pierces the septum 90, the septum 90 tightly surrounds the needle and can provide a tighter seal around the needle than a slit configuration ( assuming the configuration is the same in all other respects).
    [0091] In one embodiment, the outer diameter of the main body 92 of the septum 90 is slightly larger than the inner diameter of the lumen of the insertion tool.
    Petition 870190084587, of 08/29/2019, p. 34/102 catheter before septum 90 is installed in the lumen.
    Specifically, the outer diameter of main body 92 of septum 90 is greater than the inner diameter of catheter hub 24. When septum 90 is mounted in the lumen of catheter hub 24, the inner surface of catheter hub 24 is in contact narrow with the septum 90 and thus provides a better seal.
    [0092] In one embodiment, the first protrusion 94 of the septum is in the form of a truncated circular cone tapering from the top surface 94A of the main body 92, as shown in Figure 10B. And the circular truncated cone is coaxial with the main body 92. In one embodiment, the first protrusion 94 is integral with the main body 92.
    [0093] In one embodiment, the top surface 94Ά of the septum 90 is rounded at the periphery. In one embodiment, the top surface of the circular truncated cone is rounded at the periphery.
    [0094] In one embodiment, the septum 90 of the present invention further includes a second protrusion 98 that extends from a central portion of the bottom surface 98A of the main body 92 opposite to the top surface 94A.
    [0095]
    In one embodiment, the second protrusion 98 is in the form of a circular truncated cone tapering from the bottom surface
    98A, as shown in
    Figures
    9A
    9B.
    one circular truncad is coaxial with the main body 92. In one embodiment, the second protrusion is integral with the main orp and forms an integrated body. In another embodiment, the second protrusion 98 is in the form of a cylinder embedded in the central portion of the body
    Petition 870190084587, of 08/29/2019, p. Main 35/102 92. In another embodiment, the first protrusion 94 and the second protrusion 98 form a cylinder embedded in the central portion of the main body 92. In one embodiment, the slot 96 extends partially in the cylinder formed by the first protrusion 94 or the second protrusion 98. In another embodiment, slot 96 extends across the entire cylinder.
    [0096] In one modality, the first and the second profusions are the same in size and shape. In another embodiment, the second protrusion 98 is lower than the first protrusion 94. When the lumen of the catheter hub 24 is filled with fluid (for example, blood) on one side of the septum 90, the lateral surface of the first or the second protrusion facing the fluid assumes centripetal pressure of the fluid and wraps the needle tighter when a needle extends through the septum or closes the slit more tightly if a slit has formed through
    of the septum, thus providing best seal dog of fluid.[0097] The Figures 10C and 10D mos have a septum 90 mounted on catett cube er 24. In an modality such as shown in Figure 10C, the s epto 90 is willing ns
    distal end of a lumen 101 of the catheter hub 24, that lumen is for accepting the safety cap 26. The lumen 101 has a step 101A where the inner diameter of the lumen 101 falls distally. Proximal to step 101A, the outer diameter of the main body 92 of the septum 90 is large enough to provide a fluid sealing contact with the inner surface of the lumen 101 of the catheter hub 24. Distance to step 101A, the first protrusion 94 of the septum 90 extends into the lumen 101 distal to step 101A. To be understood, the septum can also be arranged in other
    Petition 870190084587, of 08/29/2019, p. 36/102 positions within the lumen 101 of the catheter hub 24. In another embodiment, as shown in Figure 10D, the septum 90 is sandwiched between the two steps 101A and 101B formed on the inner surface of the lumen 101 of the catheter hub 24.
    [0098] In one embodiment, the septum 90 is made of polyisoprene, silicone rubber, polyurethane, butyl rubber or latex.
    [0099] Figures 11 A and 11B show a septum 100 of an embodiment of the present invention. Referring to Figure 11A, in one embodiment, the septum 100 comprises a circular end portion 102 and a tubular portion 104 extending from the periphery of end portion 102. In one embodiment, septum 100 is in the form of a tubular with a narrow end (circular end portion 102) at the distal end of the septum 100 and an open end at the proximal end of the septum 100. Specifically, in one embodiment, the end portion 102 is a thin round film, and the tubular portion 104 extends to from the perimeter of the film in a direction perpendicular to the plane of the end portion 102.
    [00100] In one embodiment, the septum 100 further includes a protrusion 106 extending from a central portion of a surface of the circular end portion 102 opposite the tubular portion 104. In one embodiment, the protrusion 106 is in the form of a cylinder . In another embodiment, protrusion 106 is in the form of a circular truncated cone that tapers from the bottom surface. The protrusion 106 is coaxial with the circular end portion 102. In one embodiment, the protrusion 106, the circular end portion 102 and the tubular portion 104 form a piece
    Petition 870190084587, of 08/29/2019, p. 37/102 integral.
    [00101] Similar to septum 90, the portion of
    end 102 of septum 100 can be formed with or without a slit.
    [00102] Ά Figure 11B shows the septum 100 mounted on the distal part of the safety cover 26. In one embodiment, the septum 100 is arranged on the fingers of the safety cover
    2 6, CHARACTERIZED by the fact that the side wall of the
    tubular portion 104 includes at least one recess 108 which allows protrusions arranged in the fingers to extend through recess 108. In one embodiment, the number and position of recesses 108 arranged in tubular portion 104 correspond to the number and position of the protrusion arranged in the fingers of the lid security 26. As mentioned above, the fingers of the security cover are separated from each other on the distal portion of the fingers and are configured to be.
    pre: radially oriented when wrapping the needle and to be
    converged centrally when the needle is pulled out from them. The septum 100 is configured to cover / cap the fingers to provide a seal for
    prevent that the blood escapes from the fingers of the
    safety.
    [00103] On the other hand, when the fingers 62 of the cover security ; 26 are totally or partially in the inside the lumen 101 of catheter hub 24, for example,
    as shown in Figure 7B, 9 or 10D, the septum 100 disposed in the fingers 62 increases the seal between the safety cap 26 and the catheter hub 24. And the septum 100 provides appropriate friction between the safety cap 26 and the hub in
    catheter 24, and the friction requires that the user / clinician
    Petition 870190084587, of 08/29/2019, p. 38/102 apply force to separate the catheter hub 2 4 and the safety cap 26 when the safety cap 26 slides into a locked position where the tip of the
    needle is isolated inside cover in safety. [00104] Beyond of this, like U bad another modality, the septum 100 willing dec us cover ios security 26 and the septum 90 willing in lumen 101 of catheter hub 24 contact each other When cap from s 26 security and the cube
    of catheter 24 are connected. Specifically, in a
    modality, the main body 92 or the protrusion 9 4/98 of septum 90 is in touch aper 'been with the protrus 106 or portion in end 102, septum 100 when the portion in
    the finger of the safety cap 26 is fully inserted into the lumen 101 of the catheter hub 24. Such a configuration can prevent blood spillage as the needle tip passes through septa 90 and 100 and, consequently, prevent blood exposure when the safety cap 26 and catheter hub 24 are separated from each other.
    [00105] In one embodiment, the septum 100 is made of polyisoprene, silicone rubber, polyurethane, butyl rubber or latex.
    [00106]
    In one embodiment, as shown in Figure
    11B, the catheter insertion tool 10 further includes a septum 110 disposed in the lumen of the first portion 26A.
    Specifically, as an embodiment, the septum 110 is in the form of a cylinder. In one embodiment, the thickness of the septum 110 is configured to be less than the distance between the tip and the notch of the needle 18, in order to reduce the friction between the septum 110 and the needle 18.
    [00107] Similar to septum 90, septum 110 can be
    Petition 870190084587, of 08/29/2019, p. 39/102 formed with or without a crack.
    [00108] In one embodiment, the outer diameter of the septum 110 is greater than the inner diameter of the lumen of the first portion 26A of the safety cap 26 before the septum 110 is installed in the lumen.
    [00109] In one embodiment, the septum 110 is arranged at the proximal end of the lumen of the first portion 26A, so as to form a closed cavity together with the septum 100 and the lumen 101. Thus, the closed cavity prevents blood from leaking when the needle tip is isolated into the closed cavity of the safety cap 26.
    [00110] In one embodiment, the septum 110 is made of polyisoprene, silicone rubber, polyurethane, butane rubber or latex.
    Guide wire advance set [00111] Referring back to Figure 2 or Figure 3A, in one embodiment, the insertion tool 10 comprises a guide wire advance set 30 to distally advance a guide wire 32 into the patient's vasculature or proximally remove the guidewire from the patient's vasculature. In one embodiment, the wire feed assembly
    gu ia 3 0 further includes one pusher 34 to operate the movement guide wire 32 in preparation for the advancement of 2z catheter • [00112 ] The Figur at 12 A and 12 B show the view sectional of the set in guide wire feed 3 0 before and after advance the guide wire 32. In one mode, at least one less tie portion 9 gu ia 32 is arranged inside the
    lumen of needle 18. One end of the guide wire 32 is attached to an anchor point 120 in the housing 12, and the thread
    Petition 870190084587, of 08/29/2019, p. 40/102 guide 32 extends proximally from anchor point 120, enters an orifice 36 of pusher 34 through a first potion of rail 122A, extends away from orifice 36, extends distally into a second portion of rail 122B , and finally extends into the lumen of the needle 18 through the base of the needle.
    [00113] In one embodiment, rail 122A-B includes a groove aligned with hole 36 in the longitudinal direction of the catheter insertion tool. The slot serves to restrict the guide wire 32 and prevents unwanted undulations or flexing of the guide wire 32 during operation. Specifically, as an embodiment, the anchor point 120 and the first portion of the rail 122A are arranged in. an inner surface of the first portion 12A of the housing 12. The anchoring point 1.20, the first portion of the rail 122Ά and the upper opening of the hole 36 of the pusher 34 are arranged in a line, which allows the guide wire 32 to extend directly from anchor point 120 to hole 36. The second portion of rail 122B is arranged on an inner surface of the second portion 12B of housing 12. The bottom opening of hole 36, the second portion of rail 122B and the proximal end of needle 18 are arranged in a line, which allows the guide wire 32 to extend directly from hole 36 to the lumen of needle 18. In another embodiment, at least part of the rail 122A-B is a tube.
    [00114] Figure 12A shows the configuration of the guide wire advance set 30 before operation, where pusher 34 is positioned near the end
    Petition 870190084587, of 08/29/2019, p. 41/102 proximal to the housing. When pusher 34 is moved distally to a position close to that of the needle, as shown in Figure 12B, the thread 32 is distally advanced over a distance twice the movable distance of pusher 34.
    [00115] Figures 13A-13C show the structure of pusher 34. Figure 13A is a perspective view of an embodiment of pusher 34, where pusher 34 includes a pusher block 130 and a slide 132. In one embodiment, the push block 130 includes an orifice 36 extending through the push block 130 from a top surface to a bottom surface of the push block 130.
    [00116] Figure 13B is a sectional view of the push block 130, and Figure 13C is a perspective view of the push block 130. As shown in Figures 13B and 13C, the push block 130 includes four side walls that define orifice 36. In one embodiment, the four side walls of orifice 36 include a first sidewall 13 4A in the form of a flat curve and a second straight sidewall 134B opposite the first sidewall. The minimum distance between the first and second side walls 134A and 134B is wide enough to allow free longitudinal movement of a guide wire 32 and is narrow enough to restrict the oscillation of the guide wire 32. In another embodiment, the second side wall 134B is also in the form of a flat curve, where the flat surface of the second sidewall 134B is parallel to the flat surface of the first sidewall 134A. In one embodiment, the other two side walls are straight.
    Petition 870190084587, of 08/29/2019, p. 42/102 [00117] Referring back to Figure 2 and Figure 13A, in one embodiment, the slide 132 is connected to the push block 130, the push block 130 is disposed inside the housing 12 and the slide 132 is partially disposed outside the housing 12. In one embodiment, a slot is formed between the second portion 13B of the housing and the proximal portion of the first portion 13A of the housing, which secures the connecting part between the push block 130 and the slide 132 , and allows pusher 34 to slide with respect to housing 12.
    [00118] Figures 14A and 14B show another embodiment of the guide wire feed assembly 140 of the present invention. In one embodiment, the guide wire feed assembly 140 includes, a wheel 142 and a gear 144, FEATURED by the fact that gear 144 is attached to wheel 142 coaxially. The rotation of the gear 144 synchronously triggers the rotation of the wheel 142. In one embodiment, a guide wire 32 is partially wound around the outer diameter of the wheel 142.
    [00119] In one embodiment, the guide wire feed assembly 140 further includes a rack 146, which engages with the sprocket 144 via the engagement between the rack teeth 146 and the gear teeth 144. In one embodiment, a distal end of rack 146 is slidably attached to a rail arranged in the housing. The sliding movement of the rack 146 along the rail triggers the rotation of the gear 144 and the rotation of the wheel 142, and the guide wire 32 is consequently driven around the wheel 142.
    [00120] In one modality, the set of advance of
    Petition 870190084587, of 08/29/2019, p. 43/102 guide wire 140 further includes at least one tensioner 148 to restrain guide wire 32 against the peripheral surface of wheel 142. In one embodiment, at least the peripheral surface of wheel 142 is configured to provide sufficient friction to prevent slipping between the wheel 142 and guide wire 32. This can be done by special treatment of the peripheral surface or by selecting a suitable material to form the surface.
    [00121] In one embodiment, the guide wire feed assembly 140 further includes a tube rail to guide the movement of the guide wire 32.
    [00122] Advance efficiency of the advance set
    guide wire 140 depends on the relationship between the diameter of gear. 144 and wheel 142. For example, if the relationship between the diameter gear 144 and the wheel 142 is 1: 3, the relationship between distance Slipping of the rack 146 and the distance wire mobile guide is also of 1: 3. JC ~ -B— C J | -B— K Hey * JL * i. ~~ - / Μ έΉ 4 * ^ 1 4 * ^Q8 [00123] The Figures 4A-5C represent various stages
    operation of the insertion tool 10 to place catheter 22 in a patient's vasculature. For clarity, the various stages are represented with no real insertion in a patient being shown. With the insertion tool 10 in the configuration shown in Figure 2, a user grasping the insertion tool 10 first guides the distal portion needle 18 through the patient's skin at a suitable insertion site and accesses a subcutaneous vessel. The confirmation of adequate access to the vessel having been achieved is evident through the blood flash, that is, the presence of blood between the outer diameter of the needle 18
    Petition 870190084587, of 08/29/2019, p. 44/102 the internal diameter of the catheter 22 due to the blood exiting the notch from the hollow interior of the needle. Note that, in one embodiment, the presence of blood in the safety cap serves as a secondary blood flash indicator due to blood entering the housing from needle 18 when the container is accessed.
    [00124]
    After the needle access to the vessel is confirmed, sweat i operates the guide wire advance set 3 0 or
    140.
    as the guide wire advance set 30 shown in Figures 12A-13C pusher 34 is moved distally by the user's finger to advance the guide wire 32, which is initially disposed within the hollow needle 18. In another embodiment, in relation to the set guide wire feedrate 140 shown in
    Figures 14A-14B, the support 146 moved distally by the user's finger to advance the guide wire 32 distally. The distal advance of the guide wire continues until the pusher 34 has slid its total travel length distally, resulting in a predetermined length of the wire guide 32 extending beyond the distal end of the needle
    In one embodiment, further distal advancement of the pusher is avoided when the pusher block 130 contacts the needle base.
    [00125]
    Once the guide wire 32 has been fully extended into the patient's vessel, the user operates the catheter advancement assembly 20, where the catheter hub 24 is advanced distally by the user to cause the catheter 22 to slide distally over needle 18 and guide wire 32 and in the patient's vasculature through the insertion site. At this stage, distal movement
    Petition 870190084587, of 08/29/2019, p. Additional 45/102 of the catheter hub and catheter is prevented by the distal portion of the housing. The user can then slide the distal portion of the first portion of the housing relative to the second portion of the housing to release the engagement between the two parts of the housing. After release, more distal movement of the catheter hub and catheter is allowed. It should be noted that during the distal sliding of the catheter hub 24, since the safety cap 26 is initially engaged with the catheter hub 24, the safety cap 26 also slides with the catheter hub 24.
    [00126] After catheter 22, catheter hub 24 and safety cap 26 are released from the housing, the user can further advance catheter hub 24 distally and withdraw needle 18 from the patient's body. These two movements can be operated simultaneously or successively. The distal movement of the catheter hub and the safety cap in relation to the needle or housing is interrupted when the safety cap is locked at the lock point and the needle tip is isolated inside the safety cap.
    [00127] With the needle tip removed from the fingers of the safety cap and stopped inside the lumen of the first portion of the safety cap, the catheter hub 24 is free to be separated from the safety cap by the user. As mentioned, the septa in the catheter cap and the safety cap prevent exposure of the patient's blood. Then, catheter 22 remains in the patient's body, catheter hub 24 remains close to the insertion site, and housing 12, needle 18, the cap
    Petition 870190084587, of 08/29/2019, p. 46/102 safety 26 and the guide wire feed assembly can be removed.
    [00128]
    In one embodiment, the insertion tool of the present invention may include a cover or other protective device that is removably attached to the insertion tool prior to use, in order to protect the needle and catheter.
    [00129] The modalities of the invention can be incorporated in other specific forms without departing from the spirit of the present disclosure. The described modalities should be considered in all aspects only as illustrative, not restrictive. The scope of the modalities is therefore indicated by the appended claims and not by the previous description. All changes that come within the meaning and scope of the claims' equivalence must fall within its scope.
    权利要求:
    Claims (19)
    [1]
    1. Catheter insertion tool, CARACTERIΖΑΡΑ for the fact that it comprises:
    an accommodation;
    a needle extending distally from the housing; and a sliding safety cover along the needle, where the safety cover:
    is configured to be locked in the housing when sliding distally to an insulating position of the needle tip within the safety cap, and includes a first portion surrounding the needle and a second portion of a sliding shape attached to a rail, the rail being a part integral or fixed to the housing.
    [2]
    2. Catheter insertion tool, according to claim 1, CARACTERIΖΑΡΑ due to the fact that the safety cap is blocked in the housing when sliding distally to the position of insulating the needle tip inside the safety cap by means of being blocked on the rail.
    [3]
    3. Catheter insertion tool, according to claim 2, CARACTERIΖΑΡΑ in that it also comprises a catheter hub that is connected to the safety cap until the safety cap is locked in the housing when moving distally to the position insulating needle tip.
    [4]
    4. Catheter insertion tool according to claim 3, CARACTERIΖΑΡΑ in that the first portion of the safety cap comprises at least two fingers that are configured to be pressed towards an inner surface of the catheter hub when
    Petition 870200008412, of 1/17/2020, p. 4/12
    2/6 the needle stem extends through the first portion of the safety cap and to be released from the pressed position when the safety cap moves distally to the position of insulating the needle tip.
    [5]
    5. Catheter insertion tool according to claim 4, CHARACTERIΖΑΡΑ by the fact that each of the at least two fingers includes a protrusion that is inserted into a groove arranged on the inner surface of the catheter hub when the at least two fingers they are pressed radially towards the inner surface of the catheter hub when the needle rod extends through the first portion of the safety cap.
    [6]
    6. Catheter insertion tool, according to claim 3, CHARACTERIΖΑΡΑ in that the first portion of the safety cap comprises at least two fingers remaining in the same position when the needle stem extends through the first portion of the safety cap and when the safety cap moves distally to the position of isolating the needle tip.
    [7]
    7. Catheter insertion tool, according to claim 6, CARACTERIΖΑΡΑ in that each of the at least two fingers includes a protrusion that is inserted into a recess disposed on the inner surface of the catheter hub.
    [8]
    8. Catheter insertion tool, according to claim 7, CHARACTERI ΖΑΡΑ in that the proximal side of the protrusion forms an obtuse angle in relation to the finger surface, where the proximal side extends from the finger.
    [9]
    9. Catheter insertion tool, according to
    Petition 870200008412, of 1/17/2020, p. 5/12
    3/6 claim 1, CHARACTERIΖΑΡΑ due to the fact that the safety cap is locked in the housing at a first location and the needle tip is insulated within a second safety cap location when the safety cap slides into the insulating position the tip of the needle inside the safety cap, the first position being distally away from the second position.
    [10]
    10. Catheter insertion tool, according to claim 1, CHARACTERI ΖΑΡΑ due to the fact that a tactile sensation for a clinician is produced when the safety cap is locked in the housing.
    [11]
    11. Catheter insertion tool, according to claim 1, CHARACTERIΖΑΡΑ by the fact that the second portion of the safety cap is a lever, the lever includes two vertical walls that extend respectively from the two sides of a surface of the lever facing the rail, each of the two vertical walls has a horizontal part with a protrusion, the protrusion of which is blocked within a notch formed in the rail in order to block the safety cover in the housing when the safety cover moves distally to the position of isolate the tip of the needle inside the safety cap.
    [12]
    12. Catheter insertion tool, according to claim 11, CARACTERIΖΑΡΑ due to the fact that the notch is formed between two prominent projections arranged on the rail.
    [13]
    13. Catheter insertion tool, according to claim 12, CHARACTERIΖΑΡΑ due to the fact that the proximal of the two projections has an inclined slope on the side
    Petition 870200008412, of 1/17/2020, p. 6/12
    4/6 proximal and is substantially vertical to the rail surface on the distal side.
    [14]
    14. Catheter insertion tool according to claim 12, CHARACTERIΖΑΡΑ by the fact that the distance between the two projections is higher from the surface of the rail than the proximal of the two projections.
    [15]
    15. Catheter insertion tool, according to claim 11, CHARACTERIΖΑΡΑ by the fact that the vertical walls extend along the entire length of the lever, and the horizontal part is shorter than the total length of the lever.
    [16]
    16. Tool to insert a catheter into a patient's body, CHARACTERIΖΑΡΑ because it comprises:
    a housing in which at least a portion of the catheter is initially arranged;
    a needle extending distally from the housing, at least a portion of the catheter arranged over the needle;
    a guide wire initially disposed inside the needle partially;
    an advancement set for advancing the catheter distally; and a septum disposed within the advancing assembly, the septum comprises a circular end portion and a tubular portion extending from the periphery of the circular end portion
    [17]
    17. Tool for inserting a catheter into a patient's body, CHARACTERIΖΑΡΑ because it comprises:
    a housing in which at least a portion of the catheter is initially arranged;
    Petition 870200008412, of 1/17/2020, p. 7/12
    5/6 a needle extending distally from the housing, at least a portion of the catheter disposed on the needle;
    an advancement set for advancing the catheter distally;
    a guide wire initially disposed inside the needle partially; and a guide wire advance device for driving the guide wire, the guide wire advance device comprising:
    a push block, including a hole extending through the push block from a top surface to a bottom surface of the push block, wherein a first side wall of the hole is in the form of a flat curve; and a rail including a groove aligned with the hole in the longitudinal direction of the catheter insertion tool.
    [18]
    18. Tool to insert a catheter into a patient's body, CHARACTERIΖΑΡΑ because it comprises:
    a housing in which at least a portion of the catheter is initially arranged;
    a needle extending distally from the housing, at least a portion of the catheter arranged over the needle;
    a guide wire initially disposed inside the needle partially; and an advance set for advancing the catheter distally, in which the housing comprises:
    a first portion comprising a distal portion
    Petition 870200008412, of 1/17/2020, p. 12/8
    6/6 and a proximal part; and a second portion engaged with the first portion, wherein the distal portion of the first portion is configured to be able to slide distally from the second portion to release the engagement between the first portion and the second portion, and the advance assembly includes a lid that is initially arranged over the needle and is configured to be locked into the housing by distally sliding to a position to insulate the needle tip inside the safety cap.
    [19]
    19. Tool for inserting a catheter into a patient's body, according to claim 18, CHARACTERI ΖΑΡΑ in that the engagement of the first and second portions of the housing is released in preparation to slide the safety cap into the position that insulates the tip of the needle inside the safety cap.
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    同族专利:
    公开号 | 公开日
    CN108525102A|2018-09-14|
    CN108525102B|2022-01-11|
    HK1256073A1|2019-09-13|
    CN108525102A8|2019-06-11|
    JP2020508783A|2020-03-26|
    CN209221279U|2019-08-09|
    US20200001051A1|2020-01-02|
    CN114099903A|2022-03-01|
    WO2018157339A1|2018-09-07|
    AU2017401073A1|2019-09-19|
    JP6953541B2|2021-10-27|
    CA3054969A1|2018-09-07|
    EP3585471A1|2020-01-01|
    EP3585471A4|2021-03-10|
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    法律状态:
    2021-10-19| B350| Update of information on the portal [chapter 15.35 patent gazette]|
    2022-03-08| B06W| Patent application suspended after preliminary examination (for patents with searches from other patent authorities) chapter 6.23 patent gazette]|
    优先权:
    申请号 | 申请日 | 专利标题
    PCT/CN2017/075370|WO2018157339A1|2017-03-01|2017-03-01|Catheter insertion device|
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