巴西专利BR112017007698B1 COVERS FOR NEEDLES AND CATHETERS

专利PDF首页>>巴西专利

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:
needle assemblies 500 are described having a multipurpose protective cap 5. needle assemblies 500 may comprise a catheter assembly 120 having a catheter hub 75 and a catheter tube 76 or a hypodermic needle 15 mounted on a needle hub 35. the multipurpose cap 5 includes a first section 10 covering the needle 15 and a second section 20 having a base portion 40 for covering a hub, such as a needle hub 35 or a catheter hub 75. the first section 10 and the second section 20 are separable from each other along a tear line 30 and the second section 20 is reusable as a fastening device.
公开号:BR112017007698B1
申请号:R112017007698-5
申请日:2015-10-15
公开日:2022-01-18
发明作者:Aik Aun Tan；Wen Jenn Lim
申请人:B. Braun Melsungen Ag；
IPC主号:

专利说明:

Technique Field
[001] The described invention relates generally to medical devices such as insertion needles and over-needle catheters, and more particularly to needles and catheters with cap covers to cover the needles before use, where the cap covers incorporate delivery platforms. stabilization to secure catheters after successful venipuncture. Fundamentals
[002] Catheters are commonly used for a variety of infusion therapies, including infusing a patient with fluids, drawing blood from a patient, or monitoring various parameters of the patient's vascular system. Catheters are typically attached to a catheter adapter that accommodates the IV tubing attachment to the catheter. Needles used with catheter tubes have sharp points that are typically covered by a cap during packaging of catheter sets. The sharp point of such a needle poses a safety hazard that is often overcome by including a removable cap that covers the needle point and at least part of the assembly, in a thermoplastic wrap or vacuum pack. After the packaging material is removed, the lid is often removed and discarded. Following placement of the catheter tube within a patient's vasculature and after or before the catheter hub is connected to a source of IV fluid, the hub is secured to protect the access site from inadvertent movement, such as by fixation with tape the catheter hub to the patient's skin. summary
[003] Aspects of the present description relate to a needle assembly comprising a needle having a needle shaft attached to a needle hub; and a protective cap located over the needle shaft comprising a first section and a second section; said first section having a cavity having the needle shaft located therein and said second section comprising a base covering at least part of the needle hub, and a frangible section formed between the first section and the second section; and where the frangible section may be detachable to separate the first section from the second section.
[004] Another aspect of the present description is directed to a needle assembly comprising a needle attached to a needle hub and a protective cap located over at least part of the needle and where the protective cap can be separated into at least two different sections. , a first section and a second section, along a detachment line and where one of the two sections can be reused as a fixture.
[005] The needle assembly may comprise a catheter hub attached to a catheter tube and wherein the needle shaft of the needle projects through the catheter tube.
[006] The catheter hub may comprise an opening or a projection while the cap may comprise another one of an opening or projection. Projection can project through the opening. The projection may comprise a mushroom head, an arrow, a burr or a rotating pawl.
[007] Stabilizing elements can be incorporated and folded over the second section of the protective cover. An adhesive part can be attached to each stabilizing element. Each adhesive part may include a release layer.
[008] When two stabilizing elements are folded, an adhesive may be included to hold the folded ends in the folded position or the stabilizing elements may be sufficiently bendable and flexible to remain folded without the aid of an adhesive.
[009] A needle guard can be located inside the catheter hub. The needle guard may include a close wall, with an opening and two arms. The two arms may cross and the two arms may each include a distal wall.
[010] The second cap section may have two side walls and a top wall having a tapered distal end section. The top wall may be flat, it may include a texture, it may include angles, it may include ribs or combinations thereof.
[011] The first section of the protective cap may include an elongated tube or a cylindrical part and an expanded or enlarged proximal body part. The elongated tube and the enlarged proximal body part may have a cavity to accommodate a needle.
[012] The needle assembly may additionally comprise an adhesive part formed in a U-shape with a part of the adhesive part being attached to the stabilizing elements.
[013] The needle assembly may include tabs that have adjustable parts, such as parts that can be trimmed or detached to change the size of the tabs.
[014] The needle assembly may include means for attaching the first section to the second section in a detachment line. The means may include perforations, weakened parts, or one or more mechanical interlocks. The line of detachment can be straight, it can be curved or it can be wavy. The mechanical interlock, which may also be referred to as a joining device, may comprise a combination of projections and receptacles or a combination of pawls and receptacles, similar to interlock pawls in jigsaw puzzles. Projections can be pins, a rounded section, or a hemispherical section.
[015] In some examples, the receptacles may be formed into a tongue and the tongue may extend out from a proximal end of the first section or may extend out from a distal end of the second section.
[016] A sliding element can be used to help guide the pawls into engagement with the receptacles. The slider can be formed with the first section. The second section can slide on the slider when engaging the pawls and receptacles of a joining device.
[017] In one example, the detachment line, when separating the first section from the second section, may have remnants of a torn or torn surface. In other examples, the tear line may have a clean edge, such as a molded edge. For example, when the joining device is separated to separate a first section from a second section, the edges on the first and second sections may be clean and may be free of traces or residue from a torn or torn surface.
[018] The flaps can be unitarily formed to the base part of the second section or formed separately and subsequently attached to the base part, such as by welding or gluing.
[019] In some examples, when a first section is separated from a second section, the proximal end of the first section may have tongues that extend proximally. In other examples, the proximal end of the first section may have tongues, each with at least one receptacle extending proximally from the proximal end.
[020] Aspects of the present description are further directed to a needle assembly comprising a catheter hub; a catheter tube extending from a distal end of the catheter hub; a needle disposed at least in part in the catheter tube; a needle hub attached to the needle; a needle cap located over the needle and catheter tube; said needle cap comprising a first section and a second section, said first section comprising an elongate sleeve having a cavity, and said second section comprising a base portion comprising an upper opening and a lower opening and covering at least a portion of the catheter hub; at least one stabilizing element extending laterally from the base part; and wherein an engaging member on the catheter hub is sized and shaped to extend through the upper opening of the base portion after the first section separates from the second section along a line of detachment.
[021] The needle assembly may additionally comprise an adhesive part attached to at least one stabilizing element.
[022] The needle assembly in which the at least one stabilizing element may be a first flap and where a second flap extending from the base part may be incorporated.
[023] The needle assembly may further comprise a tongue at a proximal end of the sized and shaped second section to assist in removing the second section from the catheter hub.
[024] The needle assembly may additionally comprise an adhesive part formed in a U-shape with a part of the adhesive part attached to each of the two tabs.
[025] The needle assembly in which the upper opening of the second section can be a fitting.
[026] The needle assembly in which the engaging element may comprise a hook.
[027] The needle assembly in which a joining device can join the first section to the second section on the tear line.
[028] The needle assembly in which the joining device may comprise two or more projections engaging two or more receptacles or two or more pawls engaging two or more receptacles.
[029] The needle assembly on which the detachment line can be straight or wavy.
[030] The needle assembly in which the joining device can be guided by one or more sliding elements.
[031] The needle assembly in which receptacles may be located on a tongue that extends at a proximal end of the first section.
[032] A further feature of the present description is a method of stabilizing a puncture site comprising separating a first section from a second section of a protective cap along a detachment line; said first section comprising an elongate sleeve having a cavity and said second section having a base part comprising two side walls and a top wall; placing the second section over a catheter hub so that the base portion of the second section covers at least part of the catheter hub; and using the adhesive to secure the base portion against inadvertent movement.
[033] The method may further comprise attaching two side extension flaps of the base part with adhesive.
[034] The method may further comprise placing a tongue on the catheter hub through a slot in the base section.
[035] The method in which the adhesive can be applied to each of the two flaps.
[036] The method in which the detachment line can be a frangible section located between the first section and the second section.
[037] The present invention is further directed to a method of manufacturing a needle assembly as described elsewhere.
[038] A further feature of the present description includes a needle assembly comprising: a needle having a needle shaft attached to a needle hub, said needle shaft comprising a needle tip; and a protective cap located over the needle shaft comprising a first section and a second section; said first section having a cavity having the needle shaft located therein and said second section comprising a base covering at least part of the needle hub; and a tear line formed between the first section and the second section; and where the tear line is a weakened section configured to be cut to separate the first section from the second section.
[039] Another aspect of the present description includes a method of stabilizing a drilling site. The method may comprise separating a protective cap into a first section and a second section along a tear line; said first section comprising an elongate sleeve having a cavity and said second section having a base part comprising two side walls and a top wall; placing the second section over a catheter hub so that the base portion of the second section covers at least part of the catheter hub; and using the adhesive to secure the base portion against inadvertent movement. Brief Description of Drawings
[040] These and other features and advantages of the present devices, systems and methods will be better appreciated as they become better understood with reference to the specification, claims and accompanying drawings, in which: Figure 1A illustrates a perspective view of the device with the protective cap still attached; Figure 1B illustrates a partially exploded perspective view of the device of Figure 1A; Figure 2 illustrates a top view of the device with stabilizing elements; Figure 3 illustrates a side view of the device of Figure 2; Figure 4A illustrates a side view of an embodiment of the device shortly before separation; Figure 4B illustrates a side view of an embodiment of the device after separation; Figure 5 illustrates a perspective view of the second section of the device; Figure 6 illustrates a top view of the second section attached to the catheter hub; and Figure 7 illustrates a perspective view of an embodiment of the device with a bandage; Figure 8 illustrates a fastening device that is part of a protective cover after removal of a first cover section. Figures 9A to 9D illustrate an alternative protective cover in different views and different sections. Figures 10A to 10D illustrate an alternative protective cover in different views and different sections. Detailed Description
[041] The detailed description presented below with respect to the attached drawings shall serve as a description of the currently preferred embodiments of needle sets having caps with stabilizing accessories provided in accordance with aspects of the present devices, systems and methods and shall not represent the only ways in which the present devices, systems and methods can be constructed or used. The description presents the accessories and steps for the construction and use of the embodiments of the present devices, systems and methods with respect to the illustrated embodiments. It should be understood, however, that the same or equivalent functions and structures can be performed by different modalities which must also be encompassed within the spirit and scope of the present description. As denoted elsewhere, similar element numbers must indicate similar elements or characteristics.
[042] Figure 1A illustrates a perspective view of a needle assembly 500 comprising a catheter over needle assembly 120 and a cover or cap 5 which is typically frictionally engaged and/or positively engaged with the catheter assembly and removable from there. The cover or cap 5 can be used to cover a needle 15 having a sharp tip or distal tip 37 and acts as a protective cap to protect the needle 15 until use. In one example, the cover 5 may include two or more sections 10, 20 which are joined, such as being integrally formed or mechanically secured together. A first section 10 generally covers a needle 15 and catheter tube 76 of the catheter assembly 120 when placed thereon prior to use, such as during packaging the assembly in a plastic wrap or vacuum pack. Needle 15 has a needle shaft 23, a point 37, and, optionally, a change in profile, such as a crease or a bulge near the needle point 37 to interact with a needle guard.
[043] A second section 20 of the cap 5 is attached to the first section 10 and covers a catheter hub 75, or at least part of the catheter hub, and may frictionally engage or grip the catheter hub 75 to secure the cap 5 to the catheter assembly 120. In some examples, the second section 20 may grip a flange or pawl of the catheter hub 35. As discussed further below, the second section 20 may be referred to as an anchor or an attachment device and the first section 10 may be referred to as a protective sleeve. Following the removal of cap 5 from catheter assembly 120, the two sections 10, 20 may be separated or detached from each other on a tear line 30, which is located between the distal end and proximal end of cap 5. detachment 30 may be frangible or a weakened section and configured to readily tear or separate under relatively low force. The tear line 30 may be a perforation, a thin section that is weaker than the rest of the cover, a groove, or any other structural design that causes inherent weakness in the structural integrity of the cover and, when a sufficient level of strength is applied, breaks into at least two separate sections 10, 20. The line of detachment 30 may be linear or straight, curved, zigzag, or combinations thereof. Alternatively, as discussed further below, the at least two separate sections 10, 20 may detachably connect using a snap-fit arrangement, a braided arrangement, a notched arrangement, or combinations thereof and the tear line 30 between the two sections 10, 20 can be separated by snapping apart, separating the interlacing arrangement, or separating the notches.
[044] In some examples, a needle guard may be located within the catheter hub 75 to cover the needle tip 37 after retraction of the needle 15 from the catheter hub and catheter tube 76, such as following venipuncture successful. An illustrative needle guard may comprise a proximal wall having a perimeter defining an opening, two arms extending distally from the proximal wall, and a distal wall located on each arm to block the needle tip. The two arms can intersect each other when viewed from one side, either in a ready position where the assembly is ready for use on a patient, or in a protective position where the needle shield covers the needle tip to prevent pricks. inadvertent with the needle. The needle guard can interact with the change in profile on the needle shaft. For example, when the needle is retracted from the catheter hub after successful venipuncture, the change in profile may engage the perimeter in the proximal wall to retract the needle shield away from the catheter hub. In some examples, the cap 5 is used with a needle device without a catheter tube, such as a hypodermic needle or an epidural needle. Illustrative needle guards usable with the needle assembly 500 of the present disclosure include those described in U.S. Patent No. 8,647,313, the contents of which are expressly incorporated herein by reference as if set forth in full.
[045] The first section 10 of the cap 5 is generally elongated and has a cavity for receiving and covering the needle 15 and catheter tube 76, protecting a user from accidental needle sticks prior to use and/or to protect the sheath. plastic when the needle device 500 is located inside the package. As illustrated, the first section 10 is generally cylindrical in cross-section, but may take other shapes, such as being tapered, oval, complex, irregular, polygonal, etc. A distal tip 12, sometimes referred to as an end, of the first section 10 is illustrated, being configured to cover the needle tip, with a flat wall surface with one or more optional openings for ventilation. A body portion 14 of the first section 10 is sized and shaped to cover the length of the needle 15 and catheter tube 76. The length of the first section 10 may be greater than the length of the needle 15 which projects out of the hub. catheter 75 to ensure adequate space with the needle tip 37. When a relatively longer length is employed for the first section 10, it will allow the cap 5 to be used in different assemblies having different needle lengths. In some examples, the cover 5 is configured to cap or house a needle without a catheter tube, such as an injection needle or an epidural needle. The exact part of the needle and catheter tube length that the body part 14 covers may vary and may depend on various design factors. In one embodiment, the diameter of body part 14 is generally constant along its longitudinal axis. In other embodiments, the diameter may taper away from or toward the distal tip 12. The body portion 14 of the cap 5 has a proximal body portion 16 that transitions the body portion 14 from a smaller diameter section into a distal end 18 (Figure 2) for an increased cross-sectional area at a proximal end 19, which is attached to the second section 20 of the cap 5, as discussed further below. Thus, as illustrated, the first section 10 of the cap 5 has an elongate body part or elongated sleeve 17 and a proximal body part 16, which has a distal end 18 and a proximal end 19.
[046] In some examples, the proximal body part 16 includes a shoulder 33 (Figure 2) at the distal end 18 of the proximal body part. Shoulder 33 increases to a larger transverse dimension and the dimension of the larger portion remains constant towards the proximal end with varying dimensions contemplated. In the embodiment with a tapered proximal body part 16, the taper begins at the distal end 18 of the proximal body. From that point, the inner and outer dimensions of the taper increase along the longitudinal axis of the proximal body part 16 until they match that of the base part 40, sometimes referred to simply as the "base" of the second section 20 (Fig. 2) discussed below. The tapered proximal body part 16 has two side walls 22, 24 that transition from vertical to horizontal at the top 122, meeting at a junction 124, with an opening 26 (Figure 1A) located opposite the top 122. In some examples, the junction 124 is merely a raised section or an apex line at the top 122. In other examples, the junction is omitted or not noticeable. That configuration of side walls 22, 24 with an open underside 26 is configured to accommodate attachment and removal of cover 5 to and from the rest of the catheter assembly, such as detaching from engagement with the needle hub 35 or with the catheter hub 75, or both.
[047] The second section 20 generally covers the catheter hub 74 and, optionally, part of the needle hub 35 when positioned over the catheter assembly 120. In addition to covering the catheter hub 75, the second section 20 has a function additional information not recognized, appreciated or described by any known prior art. In the present description, the second section 20, in addition to serving as a cover for the catheter hub and/or needle hub, also functions as a stabilization platform. The second section 20 has a base portion 40 sized and shaped to cover the catheter hub 75, a top surface section or top panel 56, and an opening 105 (Figure 5) opposite the top surface section 56. In other embodiments , the base portion 40 is of sufficient size to cover the needle hub 35, the catheter hub 75, or all or part of both. Following a successful venipuncture, with the catheter tube 76 placed within a vein, the second section 20 may be separated from the first section 10 and may again be placed over the catheter hub 75, without the first section 10 , to stabilize the drilling site. The second section 20 may be equipped with an adhesive, applied with an adhesive, or both to anchor the hub, such as a needle hub or a catheter hub, within the second section 20 in a patient. When used with a needle without a catheter tube, such as a Seldinger needle with a needle hub, the second section 20 may be positioned over the needle hub to stabilize the needle hub.
[048] Figure 1B illustrates the cap 5 detached from the catheter assembly 120 of Figure 1A, as before use of the catheter assembly. Needle 15, needle hub 35, catheter tube 76 and catheter hub 75 remain connected for venipuncture. The cover 5 of Figures 1A and 1B may include tabs or stabilizing elements 42, 44 extending laterally from the second section 20, as discussed further below.
[049] Figure 2 illustrates a top view of the cover 5 of figures 1A and 1B with tabs 42, 44. A detachment line 30 is visible at the junction between the proximal body part 16 of the first section 10 and the base part 40 of the second section 20. In the illustrated embodiment, the tear line 30 is a perforation formed during injection molding to form the cover, which may be made from any number of known thermoplastics and typically with a semi-opaque finish with a clear cap. or a contemplated opaque lid. The perforation line may alternatively be formed in a post-molding process, such as using laser technology to weaken a section of the protective cap to facilitate separation. In some examples, the tear line 30 comprises a weakened section, such as a thin section, which readily tears to separate the first section 10 from the second section 20. In other examples, as discussed further below, the first and second sections 10, 20 can be detached along the detachment line by removing or eliminating the mechanical interlock. The incorporation of the tear line 30 allows a user to easily separate the first section 10 from the second section 20 by physical means, such as by shearing, tearing, warping, cutting, removing, removing or twisting. The deployment process will be discussed in more detail below.
[050] Extending laterally from the two sides 130, 132 of the base part 40 are stabilizing elements 42, 44 which can also be called flaps. In one example, the stabilizing elements 42, 44 are flat and flexible so that they can bend around the base section 40 when packaged in a flexible wrap and unfold to form anchor points to secure the second section 20 over the hub of catheter to a patient with one or more pieces of medical tape, as discussed further below with reference to Figure 8. Stabilizing elements 42, 44 may be embodied as tabs with any number of fittings formed thereon, including openings or holes, protrusions or protrusions to grip and/or “design” details for aesthetic purposes. As an alternative or in addition to the use of external or separate medical tape, each stabilizing element 42, 44 may incorporate an adhesive layer 46 (Figure 3) on a lower surface 48 (Figure 3) of each of the elements 42, 44 with a removable release layer or may not have any adhesive layer. The flexibility of the stabilizing elements 42, 44 allows them to be folded over the base part 40, such as folding and rolling over the upper surface of the second section 20 about the longitudinal axis of the lid during packaging and catheter assembly storage, as will be discussed further below. In other embodiments, the stabilizing elements 42, 44 are relatively firmer or more rigid so that they do not bend over the second section 20 during packaging and storage. Instead, the flexible wrap can be sized and formatted to receive the assembly with the flaps in the extended state as illustrated. In other embodiments, the stabilizing elements are omitted and the medical tape is applied directly over the base portion 40 of the second section 20 without any stabilizing elements. In another embodiment, the stabilizing elements or tabs 42, 44 are made of soft material without any adhesive material. In another embodiment, the fastener 20 and tabs 42, 44 are made of a single soft material, molded together in one piece, such as from a soft plastic. The uniquely formed attachment device 20 and tabs 42, 44 made of a soft material allow the two to bend, flex or otherwise be bent to fit the medical device or attach to the patient. In another embodiment, the fastener and tabs are made of a single hard material such as hard plastic, molded together in one piece. Each tab 42, 44 can be formed as a one-piece structure formed for the base part 40 or of two or more pieces that are joined using adhesive, solder or other joining techniques.
[051] The flaps 42, 44 may be formed to any size and shape that will allow a user to attach or otherwise secure the flaps 42, 44 to a patient 110 (Figure 7). In the illustrated embodiment, the flaps 42, 44 may optionally include frangible or adjustable portions 52, 54 along or near the outer edges 62, 64 of each stabilizing element 42, 44. The frangible or adjustable portions of the flap 52, 54 allow the tabs 42, 44 to be resized, such as to reduce in area, to match the size of the area on the patient or the size of the patient where the catheter is located. In other embodiments, tabs 42, 44 may include multiple rows of frangible lines or adjustable lines to allow resizing options depending on which frangible line is selected for separation. For embodiments without any flaps, the tape can be applied directly to the base part 40 of the second section 20. A slot or opening 55 (Figure 2) is provided in a top surface part or top panel 56 of the base part 40, near from a proximal end 58 of the base portion 40. The slot or opening 55 is configured for mechanical engagement between the second section 20 and the catheter hub 75, as will be discussed in greater detail below.
[052] Figure 3 illustrates a side view of the cover 5 of Figure 2. Illustrated in that view of the cover 5 is a first side wall 22 of the proximal body part 16 of the first section 10, which has wall surfaces that taper towards away from the lengthwise axis and from the major outer dimension of the tube portion 60. The tapered proximal body portion 16 includes a corresponding second sidewall 24 (Figure 1A) on the opposite side. The first side wall 22 of the tapered proximal part 16 transitions to the upper surface 122 of Figure 3, which is connected to the second side wall 24. On the upper surface 122, a projection 62 is provided which defines a centerline of the upper surface. extending along the geometric axis lengthwise. A top panel 56, which may be flat or have a curved portion, is located at a proximal end of the second section 20 that forms the top of the base portion 40. A tongue 64 is formed on the flat panel 56 at the proximal end 58, which in one example it merges a vertical wall with a tapered wall. Latch 64 provides a lever for a user to grip in removing cover 5 from the catheter assembly or needle device prior to use. Latch 64 may also provide the user with additional leverage to detach, push, release and/or rotate proximal body portion 16 of first section 10 of the catheter assembly to remove the cap from the catheter assembly. Additionally, the tongue 64 can provide stability for the stabilizing elements 42, 44 when they are folded over the top panel 56 of the base portion 40 of the second section 20 during packaging and storage. In other embodiments, the tongue 64 may be omitted, made taller, shorter, wider, or may have other shapes and curvatures. Adhesive portion 46 illustrated with stabilizing element 42 has a removable layer, such as a release layer, to protect the adhesive, as is well known in the art. In other embodiments, the adhesive portion 46 may be omitted and the medical tape may instead be used to adhere the stabilizing elements 42, 44 (Figure 2) to a patient. In other additional modalities, a bandage may be used in place of or in combination with medical tape. The dressing is discussed in more detail below.
[053] Figure 4A illustrates the cap 5 after needle and catheter hub removal and Figure 4B illustrates the first section 10 of the cap 5 separated from the second section 20 at the detachment point or line 30. After venipuncture well If successful using the catheter assembly 120 of Figures 1A and 1B and the needle from the needle hub removed from the catheter tube and catheter hub, the cap 5 may be used to stabilize the catheter hub 75 in the patient to stabilize and/or secure the catheter hub and puncture site. As illustrated in Figure 4B, the lid 5 is separated into two sections 10, 20 along the tear line 30. The tear line 30 is frangible and configured to tear or tear apart readily. Detachment line 30 may be a perforation, a thin section that is weaker than the rest of the covering, a groove, or any other structural design that causes inherent weakening and, when a sufficient level of force is applied, breaks or breaks. cuts on the tear line into two separate sections 10, 20. The first and second sections 10, 20 can alternatively be mechanically clamped together on the tear line 30 and the two are separable from each other by falling apart, releasing, unlocking or otherwise separating the mechanical connection and the tear line 30. Preferably, the tear line 30 is configured so that an incidental level of force is not sufficient to cause the lid to break or separate into two sections 10 , 20. However, the level of force required to separate the lid at the tear line 30 can be adjusted without departing from the scope of the present description, such as by increasing spaces or lengths and between perforations, or by increasing or reducing the material thickness of the weakened section. To cause the two sections 10, 20 to separate, a user applies force to increase tension along the underside 140 of the cover 5. Once the material of the cover 5 begins to tear along the tear line 30, the user continues to apply force until the tear progresses to the top of cap 5. At this point, the user applies force to tear the material along the tear line 30 through the top of cap 5. Obviously, other methods can be used to cut the first section from the second section, just like using scissors.
[054] After separation, the first section 10 can be discarded or recycled. The second section 20, with the first section 10 detached therefrom, can be reused as a fastening device. In one example, the second section 20, comprising a base portion 40, side walls 130, and an opening 105 on a side opposite the top surface 56, is sized and shaped to mate with the catheter hub 75 (Figure 1). ) to secure the catheter hub after venipuncture. By securing the catheter hub 75, the puncture site can be restricted against unwanted movement caused by the movement of the catheter hub. Thus, the aspect of the present description includes a portion of a cap 5, which is used during packaging to cover the needle, being retained after removal of the cap from the needle for subsequent use. For example, the second section 20 can be separated from the first part 10 and retained for reuse, such as by placing the second section 20 over the catheter hub to stabilize the catheter hub. If the stabilizing elements 42, 44 are included and are folded, they are moved from the folded position to a second, extended or ready-to-use position as illustrated in Figure 4B and Figure 5. In the present embodiment, the soft adhesive parts 46 supplied with two tabs may be used to secure the tabs or stabilizing elements 42, 44 to the patient after removing the removable layer 78 from each adhesive portion 46. In other embodiments, the stabilizing elements 42, 44 are attached to the patient using a medical tape. In other examples, the second section 20 is secured to the patient using both adhesive parts 46 on the two tabs 42 and 44 and medical tape. The second section 20 may be further secured to the patient using a mechanical interlock or connection between the catheter hub 75 and the base portion 40. For example, a tongue or hook on the catheter hub may project through the slot 55 ( figures 2 and 5) in the second section 20, which may be called an anchor or fixture, to mechanically engage the two.
[055] Figure 5 illustrates the second section, anchor or fixture 20 after separation from the first section 10 and oriented with stabilizing elements 42, 44 extending away from the base part 40 and an opening 105 on the side of below the base portion 40 facing towards the bottom of Figure 5, corresponding generally to its normal use position when located over a catheter hub 75. Figure 6 shows the second section 20 located over a catheter hub 75, such as following successful venipuncture and catheter tube 76 located in a patient's vein. To ensure that the base portion 40 of the anchor 20 aligns with the catheter hub 75 and the two engage to provide sufficient stability for the catheter hub, the slot or opening 55 in the upper surface section 56 of the base portion 40 distal to tongue 64 may be located around an engagement member 82, which may be a projection, tongue, rib, or clips formed on catheter hub 75. In some embodiments, slot/opening locations 55 and projection 82 may be inverted with the catheter hub comprising a recess and the base portion 40 comprising a projection to project into the recess in the catheter hub. The height of the two side walls 130, 132 can be selected so that at least part of the inner wall of the upper surface section 56 presses against the catheter hub 75 to securely hold the catheter hub within the internal cavity or space 144. of the anchor 20. In other examples, the two side walls 130, 132 are selected so that the inner wall of the upper surface section 56 does not press against the catheter hub. By placing the second section 20 over the catheter hub 75, the catheter hub is protected or secured against unwanted or at least excessive movement. In some embodiments, the engaging member 82 may include a simple tongue or vertical rib. In another example, the engagement member 82 may comprise a shaped tongue comprising two structural members 90, 92. A first member 90 may include a vertical or base section and the second member 92 may include a radially extending section which may be a inclined that resembles a rib, a burr or a hook. This allows the engaging member or member 82 to form more secure mechanical engagement with the slot 55 when the hook 92 is placed through the slot 55. In this way, the catheter hub 75 is mechanically engaged with the base portion 40 and fixing is not based on adhesive or tape alone.
[056] In other embodiments, the engaging element 82 may include a single "T" shaped element, where a crossbar of the "T" shaped element compresses as it enters the slot 55 and then expands as it does so. the cross bar protrudes from slot 55. Another alternative engagement member 82 may include a shaft extending from catheter hub 75 protected by a hemispherical, mushroom head-like structure. The hemispherical structure would compress radially when entering slot 55, which may be round, and then expand back after exiting the slot. Cuts or slits can be provided in the hemispherical structure to facilitate bending. In a further embodiment, a rotary lock may be used to secure catheter hub 75 to anchor 20. In another illustrative example, engagement member 82 is sized to frictionally engage slot 55 or is interference fit within the slot 55. slot 55.
[057] Figure 7 illustrates an alternative embodiment in which an adhesive part is used to secure the stabilizing elements 42, 44 of the anchor 20 to a patient, which may be the same or substantially the same as the anchors discussed elsewhere. In the present embodiment, an adhesive portion or dressing 146 in the shape of a "U" may be used to secure the stabilizing elements 42, 44 that extend from the base portion 40 to the patient 110. The adhesive portion or dressing 146 is in the shape of a "U" with the base 180 of the "U" located distally from where the catheter tube 76 enters the patient 110. Two sides 182, 184 of the "U" extend proximally from the base 180 and through the stabilizing elements or tabs 42, 44. In some embodiments, the sides 182, 184 of the "U" shaped portion can be narrower than, the same width as, or wider than the width of the stabilizing elements. The two sides 182, 184 should extend sufficiently proximally beyond the ends of the two flaps so that they can contact the patient's skin to more securely hold the flaps 43, 44 to the patient. In some embodiments, the dressing 146 is sized and shaped so that it covers all of the stabilizing elements 42, 44. In other embodiments, the dressing may leave some of one or both of the stabilizing elements 42, 44 exposed and uncovered. In additional modalities, dressing 146 may be located near the side or proximal edges of stabilizing elements 42, 44. Other modalities may utilize other dressing shapes, including a "V"-shaped dressing, a "V-shaped" dressing. D", or a bandage that extends from each of the stabilizing elements 42 in any number of shapes, including squares, rectangles, triangles, and semicircles.
[058] In some embodiments the dressing 146 is created integrated with the base portion 40 of the second section or anchor 20 and the stabilizing elements 42, such as the flaps, may be omitted. For example, the sides 182, 184 of the "U" shaped portion may be pre-attached to the sides of the base portion 40 of the second section anchor 20. In use, after catheterization, the user separates the two sections 10, 20 of the protective cap 5 and then places the base portion 40 of the second section 20 on the catheter hub 75 and detaches the release layer 78 from the dressing 146 and secures the dressing to the patient's skin. The dressing can be made of a soft material to provide additional stabilization with a greater surface area of contact with the catheter firmly adhering to the patient's skin. In one example, the sides 182, 184 of the dressing 146 are unfolded from the sides of the base portion 40, and the release liners on each side are removed and then firmly applied to the patient's skin.
[059] Figure 8 illustrates an illustrative embodiment of a second section, the fixture or anchor 20 separated from a first section 10 and where stabilizing elements 42, 44, such as flaps, are folded across the base part 40 of the second section 20. The stabilizing elements 42, 44 can be folded as illustrated to facilitate packaging of the cap 5 having the anchor 20 of Figure 8 mounted on a needle device or catheter assembly. The folded configuration of the tabs provides a relatively smaller width profile and therefore relatively smaller packing for the needle device. Stabilizing elements 42, 44 are each illustrated with an adhesive portion 46 and a release layer 78. Stabilizing elements 42, 44 may be flexible and remain in the folded configuration as illustrated, without any means of restriction or retention. . In other examples, the repositionable adhesive or other removable adhesive may be used to maintain the distal ends of each of the flaps in the folded state.
[060] Figure 9A illustrates a protective cover 5 having a first section 10 and a second section 20, similar to other protective covers discussed elsewhere. In the present embodiment, the first and second sections 10, 20 may be mechanically secured together along or near the tear line 30 using a joining device. The joining device for joining the first section 10 to the second section 20 can be incorporated internally into the cover 5 so that a smooth outer contour is provided externally for aesthetic appearance purposes. In one example, the seam is sized and shaped to provide a smooth outer transition on the two outer seam surfaces 220a, 220b at or near the tear line 30. A marker or dash 232 may be provided on the outside of the bond section. base 40 to facilitate alignment of the joining device components, as discussed further below.
[061] Figure 9B illustrates a cross-sectional side view of the cover 5 taken along the lengthwise direction of the cover illustrated in Figure 9A. In one example, two fasteners 222 (only one illustrated) may be provided internally to the cover 5. For example, a fastener 222 may be provided in each half of the cover lengthwise, such as along a section of one of the inner side walls 224 of the base part 40 and the inner side wall 226 of the proximal body part 16 of the first section 10. The coupling device 222 may each include one or more projections 228 for engaging the corresponding receptacles. 230, similar to a hole and pin or snap-fit configuration. In the illustrated example, two projections 228 are provided with the base portion 40 for projecting into two receptacles 230 provided with the proximal body portion 16 for each coupling device 222. However, the positions of the projections and receptacles may reverse with the projections located with the proximal body part 16. The engagement between each pair of projections 228 and receptacles 230 may be a snug fit, a friction fit, or an interference fit. In one example, the two projections 228 may be formed directly with the inner sidewall 224 of the second section 20 and the receptacles 230 may be provided on a tongue or extension 234 extending from one end of the first section 10.
[062] To separate the first section 10 and the second section 20, a user simply pulls the two side walls 130, 132 away from each other or compresses the two side walls 130, 132 together, depending on whether the projections 228 are located on the base portion 40 or on the proximal body portion 16. This will separate the projections 228 from the receptacles 230 to allow the first and second sections 10, 20 to separate from each other at the line of detachment 30. Once separated, the second portion 20 can be used to secure a catheter hub, as discussed elsewhere.
[063] Figure 9C illustrates the first section 10 of the cover 5 illustrated in figure 9A separated from the second section 20.
[064] Figure 9D illustrates the second section 20 of cover 5 of figure 9A separated from the first section 10. In one example, the projections 228 embody short pins or pins. In other examples, the projections 228 embody a dome-shaped section or a partial sphere, as illustrated in Figure 9D.
[065] Figure 10A illustrates a protective cover 5 having a first section 10 and a second section 20, similar to the other protective covers discussed elsewhere. In the present embodiment, the first and second sections 10, 20 may be mechanically secured together along or near a tear line 30 using a joining device 222. As illustrated, the tear line of the present embodiment may be different from straight, such as curved or wavy. The joining device 222 for joining the first section 10 to the second section 20 may be incorporated into the wall surfaces of the lid 5 and interlock in such a way that a smooth contour is provided externally for aesthetic appearance purposes.
[066] In one example, the joining device 222 may comprise a plurality of interlocking pawls 240 engaging a plurality of corresponding receptacles 246 similar to interlocking pawls in jigsaw puzzles. In the illustrated example, there are four pawls 240 for engaging four corresponding receptacles 246. In other examples, there may be fewer than four pawls 240, such as three or two pawls, or more than four pawls, such as five or six or more, for engage the same number of receptacles 246. In one example, a tongue may be incorporated along one side of the lid and two tongues in an upper section 56 of the lid 5.
[067] Figure 10B illustrates a cross-sectional side view of cover 5 taken along the lengthwise direction illustrated in Figure 10A. In one example, the coupling device 222, which comprises a plurality of interlocking pawls and receptacles, may be formed, as molded, directly at the proximal end of the proximal body portion 16 and the distal end of the base member 40. tongues and receptacles may be joined to match as illustrated in Figures 10A and 10B.
[068] To facilitate the orientation of the tongues 240 to the receptacles 246 or vice versa to mount the first and second sections 10, 20 together, one or more sliding elements 250 (only one illustrated) may optionally be provided internally to the cover 5. As illustrated, a slider 250, which may embody a ramp or a pawl, having surface features for orienting the pawls and receptacles is illustrated. Sliding element 250 can extend from first section 10 and having a surface on which base element 40 can slide when interlocking tongues and receptacles to join first and second sections. When incorporated, the presence of the sliding elements 250 also helps to prevent the first section 10 and the second section 20 from moving laterally with respect to each other to dislodge or separate the tabs from the receptacles.
[069] To separate the first section 10 and the second section 20, a user simply separates the two side walls 130, 132 of the base element 40 away from each other and elevates the base element 40 with respect to the first section. 10, or less than the first section 10 with respect to the second section, to separate the two along the tear line 30. This will separate the tongues 240 from the receptacles 246 to allow the first and second sections 10, 20 to separate from each other. the other on the tear line 30. Once separated, the second part 20 can be used to secure a catheter hub, as discussed elsewhere. In other examples, the first and second sections 10, 20 can simply be pulled in opposite directions to separate the two along the line of detachment.
[070] Figure 10C illustrates the first section 10 of the cover 5 illustrated in figure 10A separated from the second section 20.
[071] Figure 10D illustrates the second section 20 of cover 5 of figure 10A separated from the first section 10.
[072] Methods of producing and using the needle devices and caps and their components described elsewhere are within the scope of this description.
[073] Although the limited embodiments of the protective cap and catheter assemblies and their components have been specifically described and illustrated here, many modifications and variations will be apparent to those skilled in the art. Additionally, while the cap is described with respect to a catheter assembly, the same cap can be used on other needle devices, such as a hypodermic needle, a Seldinger needle, and an epidural needle, to name just a few. Likewise, it should be understood that the protective cap and catheter assemblies and their components constructed in accordance with the principles of the devices, systems and methods described may be embodied otherwise than specifically described herein. The description is also defined in the claims that follow.

权利要求:
Claims (22)
[0001]
1. Needle assembly (500), characterized in that it comprises: a needle (15) having a needle shaft (23) fixed to a needle hub (35), said needle shaft (23) comprising a needle tip (23) needle (37); and a protective cap (5) located over the needle shaft (23) comprising a first section (10) and a second section (20); said first section (10) having a cavity having the needle hub (23) located therein and said second section (20) comprising a base (40) covering at least part of the needle hub (35); and a tear line (30) located between the first section (10) and the second section (20) and where the tear line (30) is a weakened section or a joint held by a joining device (222) and is configured to be separable to separate the first section (10) from the second section (20).
[0002]
2. Needle assembly (500) according to claim 1, characterized in that it additionally comprises a catheter hub (75) attached to a catheter tube (76) and where the needle shaft (23) projects through of the catheter tube (76).
[0003]
3. Needle assembly (500), according to claim 2, characterized in that the catheter hub (75) comprises an opening (55) or a projection (82) and where the cap (5) comprises the other among the opening (55) or the projection (82).
[0004]
4. Needle set (500), according to claim 3, characterized in that the projection (82) projects through the opening (55).
[0005]
5. Needle assembly (500) according to any one of claims 1 to 4, characterized in that the stabilizing elements (42, 44) extend from the second section (20).
[0006]
6. Needle assembly (500), according to claim 5, characterized in that it additionally comprises an adhesive part (46) attached to each stabilization element (42, 44).
[0007]
7. Needle assembly (500) according to any one of claims 2 to 6, characterized in that it additionally comprises a needle guard located inside the catheter hub (75).
[0008]
A needle assembly (500) according to any one of claims 1 to 7, characterized in that the second section (20) comprises two side walls (130, 132) and a top wall (56) having a tapered distal end.
[0009]
9. Needle assembly (500) according to any one of claims 1 to 8, characterized in that it additionally comprises an adhesive part (146) formed in a U-shape with a part of the adhesive part attached to the stabilizing elements ( 42, 44).
[0010]
10. Needle assembly (500) according to any one of claims 1 to 9, characterized in that the joining device (222) comprises two or more projections (228) engaging two or more receptacles (230) or two or more pawls (240) engaging two or more receptacles (246).
[0011]
11. Needle assembly (500), characterized in that it comprises: a catheter hub (75); a catheter tube (76) extending from a distal end of the catheter hub (75); a needle (15) disposed at least in part in the catheter tube (76); a needle hub (35) attached to the needle (15); a needle cap (5) located over the needle (15) and catheter tube (76); said needle cap (5) comprising a first section (10) and a second section (20), said first section (10) comprising an elongated sleeve (17) having a cavity, and said second section (20) comprising the base part (40) comprising an upper opening (55) and a lower opening (105) and covering at least a part of the catheter hub (75); at least one stabilizing element (42 or 44) extending laterally with respect to the base part (40); and wherein an engaging member (82) on the catheter hub (75) is sized and shaped to extend through the upper opening (55) of the base portion (40) after the first section (10) separates from the second section ( 20) along a detachment line (30).
[0012]
12. Needle assembly (500) according to claim 11, characterized in that it additionally comprises an adhesive part (46) fixed to at least one stabilizing element (42 or 44).
[0013]
13. Needle assembly (500) according to claim 11 or 12, characterized in that the at least one stabilizing element (42 or 44) is a first flap (42) and additionally comprises a second flap (44) , and where the first flap (42) and the second flap (44) extend from the base part (40).
[0014]
A needle assembly (500) according to any one of claims 11 to 13, further comprising a tongue (64) at a proximal end of the second section (20) sized and shaped to assist in removing the second section (20) of the catheter hub (75).
[0015]
15. Needle assembly (500) according to claim 13 or 14, characterized in that it additionally comprises an adhesive part (146) formed in a U-shape with a part of the adhesive part (146) attached to each of the two tabs (42, 44).
[0016]
16. Needle assembly (500) according to any one of claims 11 to 15, characterized in that the upper opening (55) of the second section (20) is a socket.
[0017]
17. Needle assembly (500) according to any one of claims 11 to 16, characterized in that the engaging element (82) comprises a hook.
[0018]
18. Method of stabilizing a drilling site, characterized in that it comprises: separating a protective cover (5) into a first section (10) and a second section (20) along a detachment line (30) ; said first section (10) comprising an elongate sleeve (17) having a cavity and said second section (20) having a base portion (40) comprising two side walls (130, 132) and a top wall (56); placing the second section (20) over a catheter hub (75) so that a base portion (40) of the second section (20) covers at least part of the catheter hub (75); and the use of adhesive to secure the base part (20) and prevent its inadvertent movement.
[0019]
Method according to claim 18, characterized in that it additionally comprises fixing two flaps (42, 44) extending laterally with respect to the base part (40) with adhesive.
[0020]
Method according to claim 18 or 19, characterized in that it further comprises placing a tongue (82) of the catheter hub (75) through a fitting (55) in the base section (40).
[0021]
21. Method according to claim 19 or 20, characterized in that the adhesive is applied to each of the two flaps (42, 44).
[0022]
22. Method according to any one of claims 19 to 21, characterized in that the tear line (30) is a frangible section located between the first section (10) and the second section (20).

类似技术:

公开号 | 公开日 | 专利标题

BR112017007698B1|2022-01-18|COVERS FOR NEEDLES AND CATHETERS

ES2352409T3|2011-02-18|PACKING FOR INFUSION SET AND APPLICATION METHOD OF AN INFUSION SET.

US3973565A|1976-08-10|Winged cannula with skin securing means

ES2235515T3|2005-07-01|INTRODUCTION DEVICE OF A CATETER WITH MONOBLOCK CLOSURE FOR DIVISIBLE CASE.

ES2403146T3|2013-05-14|Passive safety device for the needle of a blood collection set

US5772638A|1998-06-30|Protector for needle

ES2227881T3|2005-04-01|SPRING CLAMP AS PROTECTION OF THE NEEDLE POINT OF AN INTRAVENOUS SAFETY CATHETER.

ES2237838T3|2005-08-01|ANCHORAGE SYSTEM TO INSURE MEDICAL LINES.

ES2751308T3|2020-03-31|Tear-away sleeve assembly with divided hemostatic valve

JP3579056B2|2004-10-20|Protective equipment

ES2214779T3|2004-09-16|NEEDLE PROTECTION ASSEMBLY.

ES2237846T3|2005-08-01|NEEDLE PROTECTOR AND ASSEMBLY DEVICE.

BR112014013871B1|2020-12-29|catheter fixation garments

US20150100025A1|2015-04-09|System for anchoring medical devices

BRPI0719018A2|2013-12-17|NEEDLE PROTECTION TONGUE STRUCTURES

MX2014005490A|2014-08-22|Catheter securement devices.

JPH10234859A|1998-09-08|Adjustable fixing utensil and catheter

JP4801708B2|2011-10-26|Fixation system such as catheter

US7367962B2|2008-05-06|Winged medical needle device

JP2004321489A|2004-11-18|Indwelling needle assembly

BR112019020816A2|2020-04-28|assembly of intravenous catheter with safety clip

PT92042B|1997-02-28|DEVICE AND CATERING INSERTION TECHNIQUE USING NEEDLE

BR112019020878A2|2020-04-28|low profile extension for a catheter set

US20150224286A1|2015-08-13|Catheter devices with securing mechanisms and related methods

JP7005683B2|2022-01-21|Needle assembly

同族专利:

公开号 | 公开日

EP3206742A1|2017-08-23|

JP2020127774A|2020-08-27|

CN107073241B|2020-09-04|

WO2016059172A1|2016-04-21|

AU2015332645B2|2020-07-02|

JP2017531467A|2017-10-26|

EP3206742B1|2021-11-24|

AU2015332645A1|2017-03-23|

US20170246429A1|2017-08-31|

US11103681B2|2021-08-31|

WO2016059172A8|2016-06-23|

CN107073241A|2017-08-18|

BR112017007698A2|2017-12-19|

引用文献:

公开号 | 申请日 | 公开日 | 申请人 | 专利标题

US832351A|1905-04-19|1906-10-02|American Gig Saddle And Felt Company|Gig-saddle.|

US3434473A|1966-11-15|1969-03-25|Ciba Geigy Corp|Hypodermic needle unit with integral needle guard|

US3714945A|1970-12-17|1973-02-06|Vicra Sterile Inc|Digit manipulable quick release cannula insertion device|

DE3991063D2|1988-09-24|1991-06-06|Sueddeutsche Feinmechanik|Kanuele insbesondere fuer die gefaesspunktion|

US5290265A|1992-05-27|1994-03-01|Davis Manufacturing Systems, Inc.|Needle cover assembly|

US5584813A|1995-06-07|1996-12-17|Minimed Inc.|Subcutaneous injection set|

US8042689B2|2006-11-22|2011-10-25|Becton, Dickinson And Company|Extravascular system packaging systems|

US9220871B2|2006-11-22|2015-12-29|Becton, Dickinson And Company|Needle shielding pawl structures|

JP2010533020A|2007-07-12|2010-10-21|スター・シリンジ・リミテッド|Needle stick prevention device|

US20090187153A1|2008-01-14|2009-07-23|West Richard L|Winged needle assembly and frangible cover|

US8323251B2|2008-01-14|2012-12-04|Fenwal, Inc.|Phlebotomy needle assembly and frangible cover|

SG185127A1|2010-05-05|2012-12-28|Poly Medicure Ltd|Needle safety device for medical devices|AT424879T|2005-07-06|2009-03-15|Vascular Pathways Inc|DEVICE FOR INTRAVENOUS CATHETER INTRODUCTION AND USE METHOD|

AT548972T|2007-05-07|2012-03-15|Vascular Pathways Inc|INTRAVENOUS CATHETER INTRODUCTION AND BLOOD SPECIMENS|

US8932258B2|2010-05-14|2015-01-13|C. R. Bard, Inc.|Catheter placement device and method|

US10384039B2|2010-05-14|2019-08-20|C. R. Bard, Inc.|Catheter insertion device including top-mounted advancement components|

US9950139B2|2010-05-14|2018-04-24|C. R. Bard, Inc.|Catheter placement device including guidewire and catheter control elements|

US8690833B2|2011-01-31|2014-04-08|Vascular Pathways, Inc.|Intravenous catheter and insertion device with reduced blood spatter|

ES2750035T3|2011-02-25|2020-03-24|Bard Inc C R|Medical component insertion device including a retractable needle|

US10232146B2|2014-09-05|2019-03-19|C. R. Bard, Inc.|Catheter insertion device including retractable needle|

CN113350614A|2015-05-15|2021-09-07|C·R·巴德股份有限公司|Catheter placement device including extendable needle safety feature|

US10493262B2|2016-09-12|2019-12-03|C. R. Bard, Inc.|Blood control for a catheter insertion device|

US20200094024A1|2017-06-09|2020-03-26|B. Braun Melsungen Ag|Adhesive encased protective caps for needle devices and related methods|

法律状态:
2020-04-14| B06U| Preliminary requirement: requests with searches performed by other patent offices: procedure suspended [chapter 6.21 patent gazette]|

2021-11-09| B09A| Decision: intention to grant [chapter 9.1 patent gazette]|

2022-01-18| B16A| Patent or certificate of addition of invention granted [chapter 16.1 patent gazette]|Free format text: PRAZO DE VALIDADE: 20 (VINTE) ANOS CONTADOS A PARTIR DE 15/10/2015, OBSERVADAS AS CONDICOES LEGAIS. |

优先权:

申请号 | 申请日 | 专利标题

US201462064916P| true| 2014-10-16|2014-10-16|

US62/064,916|2014-10-16|

PCT/EP2015/073917|WO2016059172A1|2014-10-16|2015-10-15|Caps for needles and catheters|

[返回顶部]