Delivery device
By designing a delivery device that includes a syringe and a movable plunger, and utilizing the coordinated movement of the guidewire and liquid/air, the problem of difficult blood extraction after prolonged indwelling of peripheral venous catheters is solved, achieving long catheter life and efficient blood collection.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- BECTON DICKINSON & CO
- Filing Date
- 2021-01-22
- Publication Date
- 2026-05-29
AI Technical Summary
Existing peripheral venous catheters are prone to blood collection difficulties after prolonged indwelling due to vascular stenosis, collapse, kinking or blockage. Furthermore, the catheter tip may adhere to the vascular system, making it difficult to obtain blood samples effectively.
A delivery device comprising a syringe and a movable plunger is employed, which moves a guidewire and liquid or air within a catheter assembly by pushing the plunger. The guidewire advances to overcome obstacles such as thrombi. The guidewire is designed to reduce trauma to the blood vessel and provides structural support and control through a flexible housing and biasing members.
It can prolong the lifespan of catheters in the vascular system, improve the feasibility and success rate of blood collection, reduce the risk of vascular trauma, and enhance the catheter's ability to maintain access.
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Figure CN113171511B_ABST
Abstract
Description
Technical Field
[0001] This application relates to medical devices, and more particularly to plunger-based delivery devices for facilitating vascular access. Background Technology
[0002] Catheters are commonly used for various infusion therapies. For example, catheters can be used to deliver fluids such as saline solution, various medications, and total parenteral nutrition to patients. Catheters can also be used to draw blood from patients.
[0003] A common type of catheter is the needle-type peripheral intravenous (“IV”) catheter. As the name suggests, a needle-type catheter can be fitted onto a guide needle with a sharp distal tip. The catheter and guide needle can be assembled such that the distal tip of the guide needle extends beyond the distal tip of the catheter, with the bevel of the needle facing upwards away from the patient's skin. The catheter and guide needle are typically inserted into the patient's vascular system through the skin at a shallow angle.
[0004] To verify proper placement of the guide needle and / or catheter in the blood vessel, clinicians typically confirm the presence of a "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the clinician can temporarily block flow in the vascular system and remove the needle, leaving the catheter in place for future blood draws or fluid infusions.
[0005] Blood draws using peripheral venous catheters can be challenging for a variety of reasons, especially when the catheter remains in place for more than a day. For example, when a catheter is inserted into a patient for an extended period, the catheter or vein may become more prone to narrowing, collapse, twisting, blockage by debris (e.g., fibrin clots or platelet clots), and the catheter tip may adhere to the vascular system. Therefore, catheters are generally used to obtain blood samples during catheter placement, but rarely for obtaining blood samples during the duration of catheter indwelling.
[0006] The subject matter claimed herein is not limited to solutions to any drawbacks or embodiments that operate only in environments such as those described above. Rather, this background is provided merely to illustrate an exemplary technical field in which certain implementations described herein can be practiced. Summary of the Invention
[0007] This disclosure generally relates to a delivery device that facilitates access to a patient's vascular system, and related systems and methods. In some embodiments, the delivery device can deliver a guidewire into a catheter assembly. In some embodiments, the delivery device may include a syringe that may include a barrel and a plunger movable within the barrel. In some embodiments, the plunger may include a handle and a stop coupled to a distal end of the handle. In some embodiments, the stop may include a channel that may be U-shaped or other suitable shape.
[0008] In some embodiments, the delivery device may include a guidewire disposed within the cylinder and extending through the channel. In some embodiments, in response to the plunger being pushed, the guidewire may move through the channel, and a first end of the guidewire may advance distally. In some embodiments, a second end of the guidewire may be fixed.
[0009] In some embodiments, the barrel may contain liquid. In some embodiments, in response to the plunger being pushed, the liquid may exit the distal opening of the syringe. In some embodiments, the diameter of the distal opening of the syringe may be larger than the outer diameter of the guidewire.
[0010] In some embodiments, the cylinder may contain air. In some embodiments, the cylinder may include one or more vent holes. In some embodiments, the air may exit through the vent holes in response to the plunger being pushed.
[0011] In some embodiments, in response to the plunger being pushed, the stop can move a first distance distally, and the first end of the guidewire can advance a second distance distally. In some embodiments, the second distance can be greater than the first distance. In some embodiments, the guidewire can form one or more loops.
[0012] In some embodiments, the syringe may include a flexible housing disposed within the barrel. In some embodiments, the flexible housing may prevent contact between the liquid and at least a portion of the guidewire. In some embodiments, the portion of the guidewire may be surrounded by the flexible housing. In some embodiments, the flexible housing may be configured to compress in response to distally pressing of the plunger.
[0013] In some embodiments, the syringe may include a biasing member disposed distal to the stop within the barrel. In some embodiments, the biasing member may be compressed in response to the plunger being pushed. Additionally or alternatively, in some embodiments, another biasing member may be disposed between the stop and the handle. In some embodiments, other biasing members may expand in response to the retraction of the handle.
[0014] In some embodiments, the delivery device may include a housing that is coupled to the distal end of the syringe. In some embodiments, the housing may contain liquid. In some embodiments, the guidewire may be integrally disposed proximal to the housing.
[0015] In some embodiments, the stop may be located at the distal end of the handle. In some embodiments, the U-shaped portion of the channel may be located within the handle. In some embodiments, another portion of the channel may extend through the stop. In some embodiments, the other biasing member may be located between the U-shaped portion and the handle.
[0016] In some embodiments, in response to the handle being pushed distally, the stop can move distally to a distal position, the guidewire can move through the channel, and the first end of the guidewire can advance distally. In some embodiments, the second end of the guidewire can be fixed. In some embodiments, in response to the handle being retracted proximally, the stop can remain in the distal position, the guidewire can move through the channel, and the first end of the guidewire retracts proximally.
[0017] In some embodiments, the delivery device may include a first syringe, a guidewire, a second syringe, and an adapter. In some embodiments, the first syringe may include a first barrel and a first plunger movable within the first barrel. In some embodiments, the first plunger may include a first handle and a first stop coupled to a distal end of the first handle. In some embodiments, the first stop may include a channel, which may be U-shaped. In some embodiments, air may be disposed within the first barrel. In some embodiments, the first barrel may include a vent. In some embodiments, the air may exit the vent in response to the first plunger being pushed distally.
[0018] In some embodiments, the guidewire may be disposed within the first barrel and may extend through the first channel. In some embodiments, in response to the first plunger being pushed, the first guidewire may move through the channel, and a first end of the guidewire may advance distally. In some embodiments, a second end of the guidewire may be fixed.
[0019] In some embodiments, the second syringe may include a second barrel and a second plunger movable within the second barrel. In some embodiments, the second plunger may include a second handle and a second stop coupled to a distal end of the second handle. In some embodiments, the second barrel may contain liquid. In some embodiments, in response to the second plunger being pushed, the liquid may exit a distal opening of the second syringe.
[0020] In some embodiments, the adapter may include a first port, a second port, and a third port. In some embodiments, the first port may be coupled to the distal end of the first syringe. In some embodiments, the second port may be coupled to the distal end of the second syringe. In some embodiments, the third port may be configured to be coupled to the catheter assembly.
[0021] In some embodiments, the first and second cylinders may be integrally formed. In some embodiments, the first plunger may be configured to be coupled to the second plunger such that the first and second plungers move together. In some embodiments, the first port may be integrally formed with the first syringe and / or the second port may be integrally formed with the second syringe.
[0022] It should be understood that the foregoing general description and the following detailed description are illustrative and explanatory, and do not limit the invention as claimed. It should be understood that the various embodiments are not limited to the arrangements and means shown in the accompanying drawings. It should also be understood that embodiments may be combined, other embodiments may be utilized, and structural changes may be made without departing from the scope of the various embodiments of the invention, unless so claimed. Therefore, the following detailed description should not be construed as restrictive. Attached Figure Description
[0023] Exemplary embodiments will be described and explained in further detail with reference to the accompanying drawings, wherein:
[0024] Figure 1A This is a top perspective view of an exemplary delivery device coupled to an exemplary catheter assembly according to certain embodiments, showing an exemplary plunger in a proximal position;
[0025] Figure 1BThis is a cross-sectional view of a delivery device coupled to the catheter assembly according to certain embodiments, showing a plunger in the proximal position;
[0026] Figure 2A This is a top perspective view of a delivery device coupled to the catheter assembly according to certain embodiments, showing a plunger in a distal position;
[0027] Figure 2B This is a cross-sectional view of a delivery device coupled to the catheter assembly according to certain embodiments, showing a plunger in the distal position;
[0028] Figure 3A A side view of an exemplary stop according to certain embodiments;
[0029] Figure 3B Another side view of the stop according to some embodiments;
[0030] Figure 3C A side view of another stop according to certain embodiments;
[0031] Figure 3D Another side view of another stop according to certain embodiments;
[0032] Figure 4 This is a cross-sectional view of a delivery device according to certain embodiments, showing an exemplary flexible housing;
[0033] Figure 5A This is a top perspective view of a delivery device according to certain embodiments, showing a plunger in the proximal position and an exemplary biasing member;
[0034] Figure 5B This is a top perspective view of a delivery device according to certain embodiments, showing a plunger in the distal position and the biasing member;
[0035] Figure 6A This is a cross-sectional view of a delivery device according to certain embodiments, showing a plunger in the proximal position and another exemplary biasing member;
[0036] Figure 6B This is a cross-sectional view of a delivery device according to certain embodiments, showing a plunger in the distal position and another biasing member;
[0037] Figure 7A This is a top perspective view of another delivery device according to certain embodiments;
[0038] Figure 7BThis is a top perspective view of another delivery device according to certain embodiments, showing an exemplary first syringe and an exemplary second syringe connected together;
[0039] Figure 7C This is a top perspective view of another delivery device according to certain embodiments, showing an exemplary first plunger and an exemplary second plunger joined together;
[0040] Figure 7D This is a top perspective view of another delivery device according to certain embodiments;
[0041] Figure 8 This is a top perspective view of another delivery device according to certain embodiments, showing an exemplary plunger and an exemplary advancing element in a proximal position;
[0042] Figure 9 A cross-sectional view of another delivery device according to certain embodiments;
[0043] Figure 10 This is a top perspective view of another delivery device according to certain embodiments;
[0044] Figure 11A This is a top perspective view of a delivery device connected to the catheter assembly according to certain embodiments;
[0045] Figure 11B A cross-sectional view of a delivery device coupled to the catheter assembly according to certain embodiments;
[0046] Figure 11C This is a top perspective view of a delivery device coupled to the catheter assembly according to certain embodiments, showing another exemplary plunger in the distal position followed by the proximal position;
[0047] Figure 11D This is a cross-sectional view of a delivery device coupled to the catheter assembly according to certain embodiments, showing another plunger in the distal position followed by the proximal position;
[0048] Figure 12A This is a top perspective view of a delivery device coupled to the catheter assembly according to certain embodiments, showing an exemplary guidewire in a ring-shaped configuration;
[0049] Figure 12B A cross-sectional view of a delivery device coupled to the catheter assembly according to certain embodiments, showing a guidewire in an annular configuration;
[0050] Figure 13AThis is a cross-sectional view of a delivery device according to certain embodiments, showing an exemplary outer plunger in a proximal position and an exemplary inner plunger in a proximal position;
[0051] Figure 13B This is a cross-sectional view of a delivery device according to certain embodiments, showing an inner plunger in the distal position followed by the proximal position and an outer cylinder in the distal position;
[0052] Figure 14 A cross-sectional view of a delivery device according to certain embodiments;
[0053] Figure 15A A top perspective view of an exemplary cap disposed on an exemplary blunt sleeve according to certain embodiments;
[0054] Figure 15B A cross-sectional view of a cap disposed on a blunt sleeve according to certain embodiments; and
[0055] Figure 15C This is a cross-sectional view of a cap disposed on a blunt sleeve according to certain embodiments. Detailed Implementation
[0056] Now for reference Figure 1A-2B In some embodiments, the delivery device 10 may include a syringe 12 having a barrel 14 and a plunger 16 movable within the barrel 14. Figure 1A-1B The plunger 16 of the syringe 12 according to some embodiments is shown in the proximal position. Figure 2A-2B The plunger 16 of a syringe 12 according to certain embodiments is shown in a distal position. In some embodiments, the distal end of the plunger 16 may include a stop 18 disposed within the barrel 14. In some embodiments, the stop 18 may move with a handle 19 of the plunger 16. In some embodiments, the stop 18 may include a channel 20, which may be generally U-shaped.
[0057] In some embodiments, the delivery device 10 may include a guide wire 22, which may be disposed within the cylinder 14 and extend through the channel 20. In some embodiments, in response to distal movement of the plunger 16, the stop 18 may move distally and the guide wire 22 may advance distally. In some embodiments, in response to proximal movement of the plunger 16, the stop 18 may move proximally and the guide wire 22 may retract or withdraw proximally.
[0058] In some embodiments, in response to the plunger 16 being partially and / or completely pushed distally into the barrel 14, the first end 24 of the guidewire 22 may advance distally beyond the distal opening 26 of the syringe 12, for example, as Figure 2A-2BAs shown in the diagram. In some embodiments, the second end 28 of the guidewire 22 may be secured or fixed within the delivery device 10. In some embodiments, the second end 28 of the guidewire 22 may be fixed within the barrel 14 of the syringe 12 or the distal connector 30. In some embodiments, the first end 24 of the guidewire 22 may be blunt and / or tapered, which may reduce the likelihood of trauma to the patient's vascular system upon contact with the guidewire 22. In some embodiments, the guidewire 22 may comprise metal or another suitable material.
[0059] In some embodiments, the catheter adapter 32 of the catheter assembly 34 may be coupled to the syringe 12. In further details, in some embodiments, the distal end 26 of the syringe 12 may include a distal connector 30, which may be configured to couple to the proximal end of the catheter adapter 32. In some embodiments, the distal connector 30 may include a Luer adapter, such as a sliding or threaded male Luer adapter or a sliding or threaded female Luer adapter, or another suitable connector.
[0060] In some embodiments, a needleless connector (not shown) connects the syringe 12 to the catheter adapter 32. In further details, in some embodiments, a distal connector 30 may be configured to engage with a proximal end of the needleless connector, which may engage with a proximal end of the catheter adapter 32. In some embodiments, the needleless connector may include a temporary (“PRN”) connector. In some embodiments, the needleless connector may include SMARTSITE, available from Becton, Dickinson and Company, Franklin Lake, New Jersey. TM Pinless connectors, available from Beckton Dickinson Corporation in Franklin Lake, New Jersey, are the Q-SYTE. TM Luer activated split diaphragm, available from Baxter International Ltd. via INTERLINK TM Needle-free system, or any other suitable needle-free connector.
[0061] In some embodiments, the catheter assembly 34 may include a catheter 36, which may be secured within the catheter adapter 32 and extend distally from the catheter adapter 32. In some embodiments, the catheter 36 may include a peripheral intravenous catheter, a peripherally inserted central catheter, or a midline catheter. In some embodiments, when the delivery device 10 is coupled to the catheter assembly 34, the catheter 36 may be left in the patient's vascular system. In some embodiments, the catheter adapter 32 may be integral, having an integral extension tube 38, or non-integral, without an integral extension tube 38.
[0062] In some embodiments, the blood collection device 40 may be coupled to the extension tube 38. In some embodiments, the blood collection device 40 may include a vacuum tube, a test tube 41, a syringe, or another suitable blood collection container. In some embodiments, the blood collection device 40 may include a retainer 43, which may be configured to retain the test tube 41, for example, as... Figure 1A-2B As shown in the diagram. In some embodiments, the blood collection device 40 may comprise components available from Beckton Dickinson, Inc., Franklin Lake, New Jersey. Single-use retainer.
[0063] In some embodiments, the delivery device 10 may allow the guidewire 22 to enter the patient's vascular system through the catheter 36, which can be inserted into the patient's vascular system. In some embodiments, the syringe 12 may be used to advance the guidewire 22 beyond the distal tip 39 of the catheter 36 to overcome obstacles such as thrombi, valves, and / or fibrin sheaths in or around the distal tip 39 of the catheter 36, obstacles that might otherwise prevent blood collection within the blood collection device 40. Therefore, in some embodiments, the delivery device 10 may extend the lifespan or indwelling time of the catheter 36 within the vascular system.
[0064] In some embodiments, the catheter assembly 34 may include a needle hub coupled to the proximal end of the catheter adapter 32 and a guide needle (not shown) extending distally from the needle hub. In some embodiments, the needle hub and guide needle may be removed from the catheter assembly 34 in response to the placement of the catheter 36 within the patient's vascular system, and the delivery device 10 may be coupled to the proximal end of the catheter adapter 32 after the needle hub and guide needle have been removed.
[0065] In some embodiments, the stop 18 and the channel 20 may be oriented within the cylinder 14 in various ways and at various angles. For example, when the delivery device 10 is coupled with a catheter adapter 32 positioned for insertion into a patient, the channel 20 may be oriented generally horizontally or vertically within the cylinder 14. In some embodiments, the cylinder 14 and / or the plunger 16 may be cylindrical, square, or other shapes.
[0066] In some embodiments, the cartridge 14 may contain a liquid, such as saline or another suitable flushing liquid. In some embodiments, the liquid may flush the catheter assembly 34 in response to the plunger 16 being pushed. In some embodiments, in response to the plunger 16 being pushed, the liquid may exit the distal opening 26 of the syringe 12. In some embodiments, the diameter of the distal opening 26 of the syringe 12 may be larger than the outer diameter of the guidewire 22, such that the guidewire 22 can exit the distal opening 26 and / or the liquid can flow around the guidewire 22. In some embodiments, in response to the plunger 16 being pushed, the liquid may flow around the guidewire 22 and flow into and / or through the catheter assembly 34.
[0067] In some embodiments, the barrel 14 may not contain liquid. In some embodiments, the barrel 14 of the syringe 12 may include one or more vent holes 42 that allow air to escape from the barrel 14 in response to the plunger 16 being pushed or the plunger moving distally. In some embodiments, the vent holes 42 may prevent air from entering the conduit assembly 34.
[0068] In some embodiments, the channel 20 may contact and support the guidewire 22. In some embodiments, the plunger 16 may be pushed or moved from a proximal position toward a distal direction. In some embodiments, in response to the plunger 16 being pushed, the stop 18 may move distally a first distance, the guidewire 22 may move through the channel 20, and the first end 24 of the guidewire 22 may advance distally a second distance, which may be greater than the first distance. In some embodiments, due to the U-shaped shape of the channel 20, the second distance may be twice the first distance (“1:2 advance ratio”). In some embodiments, the second distance may be at least twice the first distance. In some embodiments, the 1:2 advance ratio between the stop 18 and the first end 24 of the guidewire 22 (or another advance ratio where the second distance is greater than the first distance) and the delivery device 10 may provide reliability and structural support as the guidewire 22 advances distally, while also providing a guidewire 22 with a long distance.
[0069] In some embodiments, the diaphragm 44 may be disposed within the catheter adapter 32 and may be penetrated in response to the delivery device 10 being coupled to the catheter adapter 32. In some embodiments, the distal end of the cylinder 14 may include an auxiliary stop 46, which may comprise rubber or another suitable material. In some embodiments, the auxiliary stop 46 may prevent liquid from flowing out of or through the distal end of the cylinder 14. In some embodiments, the auxiliary stop 46 may be configured to allow liquid flow through it in response to the plunger 16 being pushed distally. In some embodiments, the auxiliary stop 46 may contact the stop 18 in response to the plunger 16 moving to a distal position. In some embodiments, the distal position may correspond to a fully pushed position. In some embodiments, the auxiliary stop 46 may be spaced apart from the stop 18 in response to the plunger 16 moving to a distal position. In some embodiments, the second end 28 may contact and / or be coupled to the auxiliary stop 46.
[0070] Now for reference Figures 3A-3B In some embodiments, channel 20 may extend from one side to the other through plunger 16. Now refer to Figure 3C-3D In some embodiments, the distal end 48 of the plunger 16 may have an outer diameter smaller than the outer diameter of the proximal portion 50 of the plunger 16 that can contact the inner side of the cylinder 14. In some embodiments, the channel 20 may extend through the distal end 48 of the plunger 16, which may shorten the channel 20 and provide less contact and friction between the channel 20 and the guidewire 22. In some embodiments, the distal end 48 may include two opposing stepped surfaces that may cut off a portion of the distal end 48 to make the channel 20 shorter.
[0071] Now for reference Figure 4 In some embodiments, at least a portion of the guidewire 22 may be disposed within a housing 50, which may be flexible. In some embodiments, the housing 50 may be accordion-shaped and / or compressible in response to the plunger 16 being pushed. In some embodiments, the housing 50 may comprise flexible plastic. In some embodiments, the proximal end of the housing 50 may be coupled to the plunger 16. In some embodiments, the housing 50 may surround a portion of the guidewire 22 between a first end 24 and a second end 28. In some embodiments, the housing 50 may surround the first end 24 and / or the second end 28. In some embodiments, the housing 50 may prevent at least a portion of the guidewire 22 from contacting liquid 52, which may be contained within the cartridge 14. In some embodiments, in response to the plunger 16 being pushed or the plunger 16 moving from a proximal position to a distal position, the first end 24 may pierce and / or exit the distal end of the housing 50.
[0072] Now for reference Figures 5A-5BIn some embodiments, the biasing member 54 may be disposed distally to the stop 18 within the cylinder 14. In some embodiments, the proximal end of the biasing member 54 may be coupled to the plunger 16. In some embodiments, the distal end of the biasing member 54 may be coupled to the auxiliary stop 46, the inner surface of the cylinder 14, or another suitable location. In some embodiments, the biasing member 54 may comprise a helical spring, which may comprise a variable or uniform pitch. In some embodiments, the helical spring may comprise a compression spring. In some embodiments, the helical spring may comprise a smaller pitch near the distal tip 39 of the conduit 36 (e.g., see...). Figure 1A-2B This prevents blood clots from entering the syringe 12 while still allowing blood to flow into the syringe 12.
[0073] In some embodiments, the biasing member 54 may comprise a metal, an elastomer, or another suitable material. In some embodiments, the biasing member 54 may reduce the force required by a clinician to push the plunger 16, which may reduce the likelihood of hemolysis.
[0074] Now for reference Figures 6A-6B In some embodiments, the biasing member 56 may be disposed proximal to the stop 18 within the cylinder 14. In some embodiments, the distal end of the biasing member 56 may be coupled to the stop 18 or another suitable location. In some embodiments, the proximal end of the biasing member 56 may be coupled to the plunger 16 or another suitable location. In some embodiments, for example in... Figure 11A-12B In this configuration, the biasing member 56 can be positioned between the U-shaped portion of the channel 20 and the distal end of the handle 19.
[0075] In some embodiments, the biasing member 56 may comprise a helical spring, which may have a variable or uniform pitch. In some embodiments, the helical spring may comprise a tension spring. In some embodiments, the helical spring may have a smaller pitch near the distal tip 39 of the conduit 36 (e.g., see...). Figure 1A-2B This prevents blood clots from entering the syringe 12 while still allowing blood to flow into the syringe 12.
[0076] In some embodiments, the biasing member 56 may comprise a metal, an elastomer, or another suitable material. In some embodiments, the biasing member 56 may reduce the force required by a clinician to retract or move the plunger 16 proximally, which may reduce the likelihood of hemolysis. In some embodiments, the inner surface of the cylinder 14 may include one or more protrusions 58 configured to contact a portion of the plunger 16, such as a base 60, to prevent the plunger from being removed proximally from the cylinder 14.
[0077] Now for reference Figure 7AIn some embodiments, the catheter system may include syringe 12 and syringe 62, both of which can be coupled to Y-adapter 64. In some embodiments, Y-adapter 64 may be coupled to catheter adapter 32. In some embodiments, Y-adapter 64 may include three or more ports, one or more of which may include a Luer adapter or another suitable connector.
[0078] In some embodiments, syringe 62 may be similar to or identical to syringe 12 of Figures 1-6 in terms of one or more features and / or operations. In some embodiments, the barrel 14 of syringe 62 may be filled with liquid 52, which may flow distally through adapter 32 and catheter assembly 34 in response to the push of plunger 16 of syringe 62. In some embodiments, syringe 62 may be used to flush catheter assembly 34 before and / or during distal advancement of guidewire 22 using syringe 12. In some embodiments, syringe 62 may be used to flush catheter assembly 34 after blood aspiration.
[0079] In some embodiments, the Y-shaped adapter 64 may be integrally formed with syringe 12 and / or syringe 62. Alternatively, in some embodiments, the Y-shaped adapter 64 may be integrally formed with catheter adapter 32. In some embodiments, the plunger of syringe 12 and the plunger 16 of syringe 62 may move independently of each other, thereby allowing clinicians to control the amount of fluid 52 flushed into the vascular system independently of inserting guidewire 22 into the vascular system. In some embodiments, the Y-shaped adapter 64 may be integrally formed as a single unit with syringe 12 and / or syringe 62.
[0080] Now for reference Figure 7B In some embodiments, the barrel of syringe 12 and the barrel 14 of syringe 62 can be integrally formed, which facilitates handling by clinicians. In some embodiments, the plunger 16 of syringe 12 and the plunger 16 of syringe 62 can move independently of each other. In other embodiments, the plunger 16 of syringe 12 and the plunger 16 of syringe 62 can be coupled together so that they move together, which facilitates handling and operation by clinicians. Referring now to... Figure 7C According to some embodiments, the plunger 16 of syringe 12 and the plunger 16 of syringe 62 can be connected together.
[0081] In some embodiments, syringe 12 (see Figures 7A-7C This can be replaced by another delivery device that includes another guidewire advance mechanism, such as a rotary advance element or a linear advance element. Now refer to Figure 8In some embodiments, the delivery device 70 may include a forwarding element 72. In some embodiments, the forwarding element 72 may include a tab or handle that a clinician can move to advance the guidewire 22 distally and / or retract it proximally. In some embodiments, the forwarding element 72 may be coupled to the proximal end of the guidewire 22. In some embodiments, the forwarding element may slide along a slot 74 provided within the housing 76, such as... Figure 8 As shown in the image.
[0082] In some embodiments, the housing 76 may include a syringe portion 78, which, with respect to one or more features and / or operations, may be related to... Figures 7A-7C The syringe 62 discussed is the same as or similar to that discussed. In some embodiments, the wall 80 may separate the syringe portion 78 from the portion of the housing 76 containing the guide wire 22. Thus, in some embodiments, liquid within the syringe portion 78 may be separated from the portion of the housing 76 containing the guide wire 22 within the delivery device 70. In some embodiments, the advance element 72 and the plunger 16 of the syringe portion 78 may advance and / or retract independently of each other. In some embodiments, the distal end of the housing 76 may include a distal connector 30. In some embodiments, the syringe 62 (e.g., see...) Figures 7A-7B It can be connected to the proximal end of the housing 76, which may not include the syringe portion.
[0083] Now for reference Figure 7D In some embodiments, the path of guidewire 22 can be generally straight as it moves distally. In some embodiments, the distal port 77 and proximal port 79 of adapter 64 can be generally aligned with syringe 12 so that the path of guidewire 22 is generally straight as it moves distally. In some embodiments, the distal movement of the guidewire along a generally straight path can be accomplished in various ways, such as, for example, by a barrel 14 of a different size between syringe 12 and syringe 62.
[0084] Now for reference Figure 9In some embodiments, syringe 62 may be coupled to housing 82, which may include guidewire 22. In some embodiments, in response to plunger 16 being pushed, fluid 52 may flow distally through housing 82 and propel guidewire 22 into catheter adapter and beyond the distal tip of catheter extending from catheter adapter. In some embodiments, the proximal end of guidewire 22 may include an enlarged diameter portion 83 that may engage with a portion of housing 82 (e.g., distal opening 84) or catheter adapter to prevent further distal movement of guidewire 22. In some embodiments, the distal end of housing 82 may include a distal connector 86 that may be coupled to catheter adapter. In some embodiments, distal connector 86 may include a sliding or threaded male Luer adapter or a sliding or threaded female Luer adapter, or another suitable connector.
[0085] Now for reference Figure 10 In some embodiments, the distal connector 30 of the syringe 12 may be coupled to a housing 88, which may be filled with liquid 52. In some embodiments, in response to the plunger 16 being pushed, liquid 52 may flow distally through a distal opening 90 of the housing 88 and flush a catheter assembly that may be coupled to the distal connector 92 of the housing 88. In some embodiments, the distal connector 92 may comprise a sliding or threaded male Luer adapter or a sliding or threaded female Luer adapter, or another suitable connector. In some embodiments, the housing 88 may prevent contact between liquid 52 and guidewire 22 prior to the plunger 16 being pushed. In some embodiments, in response to the plunger 16 being pushed, guidewire 22 may advance distally through the housing 88 and through the catheter assembly.
[0086] Now for reference Figure 11A-11D In some embodiments, the stop 18 may not be coupled to the handle 19 of the plunger 16. In some embodiments, in response to the handle 19 being in the proximal position, for example, as Figure 11A-11B As shown, the stop 18 can approach the distal end of the handle 19. In some embodiments, the stop 18 can move distally in response to the handle 19 moving from a proximal position to a distal position. In some embodiments, the stop 18 can remain in response to the handle 19 being retracted proximally after it has been moved from a proximal position to a distal position, for example, as shown. Figure 11C-11D As shown in the diagram. In these embodiments, the channel 20 may be located within the distal portion of the handle 19 and the stop 18. In some embodiments, after blood collection is complete, the handle 19 may be retracted proximally, but the stop 18 may remain in place to prevent blood from entering the syringe 12.
[0087] Now for reference Figure 12A-12B In some embodiments, the plunger 16 can be pushed or moved from a proximal position toward a distal direction. In some embodiments, in response to the plunger 16 being pushed distally a first distance, the guidewire 22 can move through the channel 20 and the first end 24 of the guidewire 22 can advance distally a second distance, the second distance being greater than the first distance. In some embodiments, when the plunger 16 is in the proximal position, the guidewire 22 can form one or more loops. In these embodiments, the guidewire 22 can include multiple bends or U-shaped portions. In some embodiments, the guidewire 22 can include a first U-shaped portion 94 and a second U-shaped portion 96, for example, as shown in the image. Figure 12A-12B As shown in the diagram. In some embodiments, the second end 28 may be coupled to the inner surface of the plunger 16, the cylinder 14, or another suitable location. In some embodiments, the second distance may be twice as large as the first distance due to the multiple bends and annular structure of the guidewire 22.
[0088] Now for reference Figures 13A-13B In some embodiments, the syringe 12 may include an outer plunger 98 and an inner plunger 100, the inner plunger 100 being disposed within the outer plunger 98 and movable proximally and distally relative to the outer plunger 98. In some embodiments, the outer plunger 98 may be disposed within a barrel 14 and movable proximally and distally relative to the barrel 14. In some embodiments, a stop 18 may be coupled to the distal end of the outer plunger 98. In some embodiments, a channel 20 may be disposed in the distal end of the inner plunger 100.
[0089] In some embodiments, for example, such as Figure 13A As shown, the outer plunger 98 and the inner plunger 100 can be positioned in a proximal position. In some embodiments, the outer plunger 98 and the inner plunger 100 can advance simultaneously from the proximal position toward the distal direction. In response to the simultaneous distal advancement of the outer plunger 98 and the inner plunger 100, the guidewire 22 and the stop 18 can advance distally. In some embodiments, the stop 18 can approach the distal end of the inner plunger 100. In some embodiments, blood collection can be performed after the simultaneous distal advancement of the outer plunger 98 and the inner plunger 100. In some embodiments, in response to completion of blood collection, the inner plunger 100 can retract proximally, and the outer plunger 98 can remain in the appropriate position, for example, as... Figure 13B As shown in the diagram. In some embodiments, a stop 18 disposed within the distal end of the barrel 14 can prevent blood from entering the syringe 12.
[0090] Now for reference Figure 14In some embodiments, the extension tube 102 may extend from the barrel 14, the distal connector 30, or another portion of the syringe 12. In some embodiments, the proximal end of the extension tube 102 may be coupled to a blood collection device. In some embodiments, a diaphragm 104 may be disposed between the extension tube 102 and the proximal portion of the barrel 14. In some embodiments, a guidewire 22 may extend through the diaphragm 104.
[0091] In some embodiments, clinicians can use catheters (e.g., see...) Figure 1A-2B The catheter 36 is inserted into the vascular system and the plunger 16 is pulled proximally to collect a blood sample from the patient. In some embodiments, the clinician may aspirate blood through an extension tube 38 (e.g., see...). Figure 1A-2B ) or extension tube 102.
[0092] Now for reference Figures 15A-15C In some embodiments, the blunt sleeve 106 of the connector 30 may form a distal opening 26. In some embodiments, a cap 108 may surround the blunt sleeve 106. In some embodiments, the cap 108 may include one or more protrusions 110 that may facilitate a clinician's grasp of the cap 108 before the clinician removes it from the blunt sleeve 106. In some embodiments, for example, as... Figure 15B As shown, the distal end 112 of the cap 108 may be closed, which prevents the guidewire 22 from moving distally to the blunt cannula 106 during transport and / or instillation. In some embodiments, the cap 108 may include one or more vents extending through the cap 108 proximal to the distal end 112.
[0093] All examples and conditional language cited herein are intended for pedagogical purposes to aid the reader's understanding of the invention and the concepts contributed by the inventors to advance the art, and should be interpreted as not being limited to such specifically enumerated examples and conditions. Although embodiments of the invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made thereto without departing from the spirit and scope of the invention.
Claims
1. A delivery device for delivering a guidewire into a catheter assembly, characterized in that, The delivery device includes: A syringe comprising a barrel and a plunger movable within the barrel, wherein the plunger includes a handle and a stop coupled to a distal end of the handle, wherein the stop includes a channel; and A guide wire disposed within the cylinder and extending through the channel, wherein the guide wire is configured such that, in response to the plunger being pushed, the guide wire moves through the channel and a first end of the guide wire advances in a distal direction, wherein a second end of the guide wire is fixed.
2. The delivery device according to claim 1, characterized in that, The cylinder contains liquid, wherein the delivery device is configured such that, in response to the plunger being pushed, the liquid exits from the distal opening of the syringe, wherein the diameter of the distal opening of the syringe is greater than the outer diameter of the guidewire.
3. The delivery device according to claim 1, characterized in that, The cylinder is filled with air, and the cylinder includes a plurality of vent holes, wherein the vent holes are configured such that, in response to the plunger being pushed, the air exits the vent holes.
4. The delivery device according to claim 1, characterized in that, The delivery device is configured such that, in response to the plunger being pushed, the stop moves a first distance in a distal direction, and the first end of the guidewire advances a second distance in a distal direction, wherein the second distance is greater than the first distance.
5. The delivery device according to claim 1, characterized in that, The barrel contains liquid, and the syringe further includes a flexible housing disposed within the barrel, wherein the flexible housing prevents contact between the liquid and at least a portion of the guidewire, wherein the at least a portion of the guidewire is surrounded by the flexible housing, and wherein the flexible housing is configured to compress in response to the plunger being pushed.
6. The delivery device according to claim 1, characterized in that, The syringe further includes a biasing member disposed distal to the stop within the barrel, wherein the biasing member is configured to be compressed in response to the plunger being pushed.
7. The delivery device according to claim 1, characterized in that, The syringe further includes a biasing member disposed between the stop and the handle, wherein the biasing member is configured to extend in response to retraction of the handle.
8. The delivery device according to claim 1, characterized in that, The delivery device further includes a housing coupled to the distal end of the syringe, wherein the housing contains saline solution, and wherein the guidewire is integrally disposed proximally to the housing.
9. The delivery device according to claim 1, characterized in that, The guidewire forms one or more loops.
10. A delivery device for delivering a guidewire into a catheter assembly, characterized in that, The delivery device includes: A syringe comprising a barrel and a plunger movable within the barrel, wherein the plunger includes a handle and a stop disposed at a distal end of the handle, wherein the syringe further includes a channel, wherein a U-shaped portion of the channel is disposed within the handle, and wherein another portion of the channel extends through the stop; and A guidewire disposed within the cylinder and extending through the channel, wherein the delivery device is configured such that, in response to the handle being pushed distally, the stop moves distally to a distal position, the guidewire moves through the channel, and a first end of the guidewire advances distally, wherein a second end of the guidewire is fixed, and wherein, in response to the handle being retracted proximally, the stop remains in the distal position, the guidewire moves through the channel, and the first end of the guidewire retracts proximally.
11. The delivery device according to claim 10, characterized in that, The cylinder contains liquid, wherein the delivery device is configured such that, in response to the plunger being pushed, the liquid exits a distal opening of the syringe, wherein the diameter of the distal opening of the syringe is greater than the outer diameter of the guidewire.
12. The delivery device according to claim 10, characterized in that, The cylinder is filled with air, and the cylinder includes a plurality of vent holes, wherein the vent holes are configured such that, in response to the plunger being pushed, the air exits the vent holes.
13. The delivery device according to claim 10, characterized in that, The delivery device is configured such that, in response to the plunger being pushed, the stop moves a first distance in a distal direction, and the first end of the guidewire advances a second distance in a distal direction, wherein the second distance is greater than the first distance.
14. The delivery device according to claim 10, characterized in that, The barrel contains liquid, and the syringe further includes a flexible housing disposed within the barrel, wherein the flexible housing prevents contact between the liquid and at least a portion of the guidewire, wherein the at least a portion of the guidewire is surrounded by the flexible housing, and wherein the flexible housing is configured to compress in response to the plunger being pushed.
15. The delivery device according to claim 10, characterized in that, The syringe further includes a biasing member disposed distal to the stop within the barrel, wherein the biasing member is configured to be compressed in response to the plunger being pushed.
16. The delivery device according to claim 10, characterized in that, The syringe further includes a biasing member disposed between the U-shaped portion and the handle, wherein the biasing member is configured to extend in response to retraction of the handle in a proximal direction.
17. A delivery device for delivering a guidewire into a catheter assembly, characterized in that, The delivery device includes: A first syringe, the first syringe including a first barrel and a first plunger movable within the first barrel, wherein the first plunger includes a first handle and a first stop connected to a distal end of the first handle, wherein the first stop includes a channel, wherein the first barrel is filled with air, wherein the first barrel includes a plurality of vent holes, wherein the vent holes are configured such that, in response to the first plunger being pushed, the air exits the vent holes; A guide wire disposed within the first cylinder and extending through the channel, wherein the guide wire is configured such that, in response to the first plunger being pushed, the guide wire moves through the channel, and a first end of the guide wire advances in a distal direction, wherein a second end of the guide wire is fixed; A second syringe, comprising a second barrel and a second plunger movable within the second barrel, wherein the second plunger includes a second handle and a second stop coupled to a distal end of the second handle, wherein the second barrel contains liquid, and wherein the delivery device is configured such that, in response to the second plunger being pushed, the liquid exits a distal opening of the second syringe; and An adapter including a first port, a second port, and a third port, wherein the first port is connected to the distal end of the first syringe, the second port is connected to the distal end of the second syringe, and the third port is configured to be connected to the catheter assembly.
18. The delivery device according to claim 17, characterized in that, The first cylinder and the second cylinder are integrally formed.
19. The delivery device according to claim 17, characterized in that, The first plunger is connected to the second plunger.
20. The delivery device according to claim 17, characterized in that, The first port is integrally formed with the first syringe, or the second port is integrally formed with the second syringe.