Plunger-type delivery device for introducing a guidewire into a catheter
The delivery device with a syringe and guidewire mechanism addresses the challenges of extended catheter use by enabling efficient blood collection through vascular obstructions, enhancing catheter longevity and sample retrieval.
Patent Information
- Application Number
- JP2022545015
- Authority / Receiving Office
- JP · JP
- Patent Type
- Patents
- Current Assignee / Owner
- Priority Date
- 2021-01-11
- Filing Date
- 2021-01-12
- Publication Date
- 2025-06-05
- Estimated Expiration
- 2041-01-12
AI Technical Summary
Catheters used for extended periods face challenges such as stenosis, kinking, and adhesion, making it difficult to draw blood samples efficiently.
A delivery device with a syringe and guidewire mechanism that allows for the advancement and retraction of a guidewire through a catheter assembly, facilitating access to the patient's vasculature and overcoming obstacles like clots and fibrin sheaths.
Enhances the ability to collect blood samples over extended catheter dwell periods by navigating through vascular obstructions, extending the catheter's residence time and ensuring reliable blood withdrawal.
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Abstract
Description
[Technical field]
[0001] background Catheters are commonly used for a variety of infusion therapies. For example, catheters may be used to infuse fluids, such as normal saline, various medications, and total parenteral nutrition, into a patient. Catheters may also be used to withdraw blood from a patient.
[0002] A common type of catheter is the over-the-needle peripheral intravenous ("IV") catheter. As the name suggests, an over-the-needle catheter may be mounted over an introducer needle having a sharp distal tip. The catheter and introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the catheter with the bevel of the needle pointing away from the patient's skin. The catheter and introducer needle are typically inserted through the skin into the patient's vascular system at a shallow angle.
[0003] To confirm that the introducer needle and / or catheter are properly placed within the blood vessel, the practitioner will typically check for a "flashback" of blood in the flashback chamber of the catheter assembly. Once needle placement is confirmed, the practitioner may temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawals or fluid injections.
[0004] Drawing blood using a peripheral venous catheter may be difficult for several reasons, especially if the catheter is left in place for more than a day. For example, if a catheter remains inserted in a patient for an extended period of time, the catheter or vein may become more susceptible to stenosis, collapse, kinking, obstruction by debris (e.g., fibrin or platelet clumps), and adhesion of the catheter tip to the vasculature. For this reason, catheters are often used to obtain blood samples at the time of catheter placement, but much less frequently used to obtain blood samples during the catheter dwell period.
[0005] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is only provided to illustrate one example technology area in which some implementations described herein may be practiced.
[0006] overview The present disclosure generally relates to a delivery device that facilitates access to a patient's vasculature, as well as associated systems and methods. In some embodiments, the delivery device may deliver a guidewire into a catheter assembly. In some embodiments, the delivery device may include a syringe, which may include a barrel and a plunger movable within the barrel. In some embodiments, the plunger may include a handle and a stopper coupled to a distal end of the handle. In some embodiments, the stopper may include a channel, which may be U-shaped or other suitable shape.
[0007] In some embodiments, the delivery device may include a guidewire, which may be disposed within the barrel and may extend through the channel. In some embodiments, in response to the plunger being depressed, the guidewire may move through the channel and a first end of the guidewire may be advanced distally. In some embodiments, a second end of the guidewire may be fixed.
[0008] In some embodiments, the barrel may contain a liquid. In some embodiments, in response to the plunger being depressed, the liquid may exit the distal opening of the syringe. In some embodiments, the diameter of the distal opening of the syringe may be greater than the outer diameter of the guidewire.
[0009] In some embodiments, air may be disposed within the barrel. In some embodiments, the barrel may include one or more vents. In some embodiments, air may exit the vents in response to the plunger being depressed.
[0010] In some embodiments, in response to the plunger being depressed, the stopper may be moved a first distance in a distal direction and the first end of the guidewire may be advanced a second distance in a distal direction. In some embodiments, the second distance may be greater than the first distance. In some embodiments, the guidewire may form one or more loops.
[0011] 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, a 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 the plunger being pushed distally.
[0012] In some embodiments, the syringe may include a biasing member, which may be disposed within the barrel distal to the stopper. In some embodiments, the biasing member may be compressed in response to the plunger being depressed. Additionally or alternatively, in some embodiments, another biasing member may be disposed between the stopper and the handle. In some embodiments, the other biasing member may expand in response to retraction of the handle.
[0013] In some embodiments, the delivery device may include a housing, which may be coupled to a distal end of the syringe. In some embodiments, the housing may contain the liquid. In some embodiments, the entire guidewire may be disposed proximally relative to the housing.
[0014] In some embodiments, the stopper may be disposed at a distal end of the handle. In some embodiments, the U-shaped portion of the channel may be disposed within the handle. In some embodiments, another portion of the channel may extend through the stopper. In some embodiments, another bias member may be disposed between the U-shaped portion and the handle.
[0015] In some embodiments, in response to pushing the handle in a distal direction, the stopper may move in a distal direction to a distal position, the guidewire may move through the channel, and the first end of the guidewire may be advanced in a distal direction. In some embodiments, the second end of the guidewire may be fixed. In some embodiments, in response to retracting the handle in a proximal direction, the stopper may remain in a distal position, the guidewire may move through the channel, and the first end of the guidewire may be retracted in a proximal direction.
[0016] 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 stopper coupled to a distal end of the first handle. In some embodiments, the first stopper 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 an air vent. In some embodiments, air may exit the air vent in response to pushing the first plunger in a distal direction.
[0017] In some embodiments, a 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 depressed, the first guidewire may move through the channel and a first end of the guidewire may be advanced distally. In some embodiments, a second end of the guidewire may be fixed.
[0018] 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 stopper coupled to a distal end of the second handle. In some embodiments, the second barrel may contain a liquid. In some embodiments, in response to the second plunger being pressed, the liquid may exit a distal opening of the second syringe.
[0019] 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 a distal end of a first syringe. In some embodiments, the second port may be coupled to a distal end of a second syringe. In some embodiments, the third port may be configured to couple to a catheter assembly.
[0020] In some embodiments, the first barrel and the second barrel may be integrally formed. In some embodiments, the first plunger may be configured to couple to the second plunger such that the first plunger and the second plunger 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 port.
[0021] It is understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not intended to restrict the invention as claimed. It is to be understood that the various embodiments are not limited to the arrangement and instrumentality shown in the drawings. It is also to be understood that the embodiments may be combined or 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 is not to be taken in a limiting sense.
[0022] Brief description of some figures of the drawing Example embodiments will be detailed and explained with additional specificity and detail through the use of the accompanying drawings therein. [Brief description of the drawings]
[0023] [Figure 1A] FIG. 1A is a top perspective view of an exemplary delivery device coupled to an exemplary catheter assembly, showing an exemplary plunger in a proximal position, in accordance with some embodiments. [Figure 1B] FIG. 1B is a cross-sectional view of a delivery device coupled to a catheter assembly showing the plunger in a proximal position, according to some embodiments. [Figure 2A] FIG. 2A is a top perspective view of a delivery device coupled to a catheter assembly, showing the plunger in a distal position, according to some embodiments. [Figure 2B] FIG. 2B is a cross-sectional view of a delivery device coupled to a catheter assembly, showing the plunger in an distal position, according to some embodiments. [Figure 3A] FIG. 3A is a side view of an exemplary stopper, according to some embodiments. [Figure 3B] FIG. 3B is another side view of the stopper, according to some embodiments. [Figure 3C] FIG. 3C is a side view of another stopper, according to some embodiments. [Figure 3D]FIG. 3D is another side view of another stopper, according to some embodiments. [Figure 4] FIG. 4 is a cross-sectional view of a delivery device showing an exemplary flexible housing, according to some embodiments. [Figure 5A] FIG. 5A is a top perspective view of a delivery device showing the plunger in a proximal position and an exemplary biasing member, according to some embodiments. [Figure 5B] FIG. 5B is a top perspective view of a delivery device showing the plunger and biasing member in an distal position, according to some embodiments. [Figure 6A] FIG. 6A is a cross-sectional view of a delivery device showing the plunger in a proximal position and another exemplary biasing member, according to some embodiments. [Figure 6B] FIG. 6B is a cross-sectional view of a delivery device showing the plunger in an distal position and another biasing member, according to some embodiments. [Figure 7A] FIG. 7A is a top perspective view of another delivery device, according to some embodiments. [Figure 7B] FIG. 7B is a top perspective view of another delivery device showing an exemplary first syringe and an exemplary second syringe coupled together, according to some embodiments. [Figure 7C] FIG. 7C is a top perspective view of another delivery device showing an exemplary first plunger and an exemplary second plunger coupled together, according to some embodiments. [Figure 7D] FIG. 7D is a top perspective view of another delivery device, according to some embodiments. [Figure 8] FIG. 8 is a top perspective view of another delivery device showing an exemplary plunger and an exemplary advancement element in a proximal position, according to some embodiments. [Figure 9] FIG. 9 is a cross-sectional view of another delivery device, according to some embodiments. [Figure 10] FIG. 10 is a top perspective view of another delivery device, according to some embodiments. [Figure 11A]FIG. 11A is a top perspective view of a delivery device coupled to a catheter assembly, according to some embodiments. [Figure 11B] FIG. 11B is a cross-sectional view of a delivery device coupled to a catheter assembly, according to some embodiments. [Figure 11C] FIG. 11C is a top perspective view of a delivery device coupled to a catheter assembly showing another exemplary plunger in a proximal position after being in a distal position, according to some embodiments. [Figure 11D] FIG. 11D is a cross-sectional view of a delivery device coupled to a catheter assembly showing the other plunger in a proximal position after being in a distal position according to some embodiments. [Figure 12A] FIG. 12A is a top perspective view of a delivery device coupled to a catheter assembly showing an exemplary guidewire in a looped configuration, according to some embodiments. [Figure 12B] FIG. 12B is a cross-sectional view of a delivery device coupled to a catheter assembly, showing the guidewire in a looped configuration, according to some embodiments. [Figure 13A] FIG. 13A is a cross-sectional view of a delivery device showing an exemplary outer plunger in a proximal position and an exemplary inner plunger in a proximal position, according to some embodiments. [Figure 13B] FIG. 13B is a cross-sectional view of a delivery device showing the inner plunger in a proximal position after being in a distal position and the outer barrel in a distal position, according to some embodiments. [Figure 14] FIG. 14 is a cross-sectional view of a delivery device, according to some embodiments. [Figure 15A] FIG. 15A is a top perspective view of an exemplary cap disposed on an exemplary blunt cannula, according to some embodiments. [Figure 15B] FIG. 15B is a cross-sectional view of a cap placed over a blunt cannula, according to some embodiments. [Figure 15C] FIG. 15C is a cross-sectional view of a cap placed over a blunt cannula, according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0024] Description of the embodiments 1A-2B, in some embodiments, a delivery device 10 may include a syringe 12 having a barrel 14 and a plunger 16 movable within the barrel 14. FIGS. 1A-1B illustrate the plunger 16 of the syringe 12 in a proximal position, according to some embodiments. FIGS. 2A-2B illustrate the plunger 16 of the syringe 12 in a distal position, according to some embodiments. In some embodiments, a distal end of the plunger 16 may include a stopper 18, which may be disposed within the barrel 14. In some embodiments, the stopper 18 may be movable with a handle 19 of the plunger 16. In some embodiments, the stopper 18 may include a channel 20, which may be generally U-shaped.
[0025] In some embodiments, the delivery device 10 may include a guidewire 22, which may be disposed within the barrel 14 and may extend through the channel 20. In some embodiments, in response to distal movement of the plunger 16, the stopper 18 may be moved distally and the guidewire 22 may be advanced distally. In some embodiments, in response to proximal movement of the plunger 16, the stopper 18 may be moved proximally and the guidewire 22 may be retracted or withdrawn proximally.
[0026] In some embodiments, the first end 24 of the guidewire 22 may be advanced distally beyond the distal opening 26 of the syringe 12 in response to the plunger 16 being pushed distally partially and / or completely within the barrel 14, as illustrated, for example, in FIGS. 2A-2B. 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 or the distal connector 30 of the syringe 12. 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 vasculature if contacted with the guidewire 22. In some embodiments, the guidewire 22 may comprise a metal or other suitable material.
[0027] In some embodiments, the catheter adapter 32 of the catheter assembly 34 may be coupled to the syringe 12. More specifically, in some embodiments, the distal end 26 of the syringe 12 may include a distal connector 30, which may be configured to mate with a proximal end of the catheter adapter 32. In some embodiments, the distal connector 30 may include a luer adapter, such as a slip or thread male or slip or thread female luer adapter, or another suitable connector.
[0028] In some embodiments, a needleless connector (not shown) may connect the syringe 12 to the catheter adapter 32. More specifically, in some embodiments, the distal connector 30 may be configured to mate with a proximal end of a needleless connector, which may be coupled to the proximal end of the catheter adapter 32. In some embodiments, the needleless connector may include a prorenata ("PRN") connector. In some embodiments, the needleless connector may include a SMARTSITE™ Needle-Free Connector available from Becton, Dickinson and Company of Franklin Lakes, NJ, a Q-SYTE™ Luer Activated Split Septum available from Becton, Dickinson and Company of Franklin Lakes, NJ, an INTERLINK™ Needlefree System available from Baxter International, Inc., or other suitable needleless connector.
[0029] In some embodiments, the catheter assembly 34 may include a catheter 36, which may be secured within the catheter adapter 32 or may 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, the catheter 36 may be placed within the patient's vasculature when the delivery device 10 is coupled to the catheter assembly 34. In some embodiments, the catheter adapter 32 may be integral, having an integral extension tube 38, or non-integral, having no integral extension tube 38.
[0030] In some embodiments, a blood collection device 40 may be coupled to extension tube 38. In some embodiments, blood collection device 40 may include a vacuum tube, a test tube 41, a syringe, or another suitable blood collection container. In some embodiments, blood collection device 40 may include a holder 43, which may be configured to hold a test tube 41, as illustrated, for example, in FIGS. 1A-2B. In some embodiments, blood collection device 40 may include a VACUTAINER® one-use holder available from Becton, Dickinson and Company, Franklin Lakes, New Jersey.
[0031] In some embodiments, the delivery device 10 may provide access to the patient's vasculature via a catheter 36, into which a guidewire 22 may be inserted. 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 clots, valves, and / or fibrin sheaths in or around the distal tip 39 of the catheter 36 that might otherwise prevent blood collection in a blood collection device 40. Thus, in some embodiments, the delivery device 10 may extend the life or residence time of the catheter 36 within the vasculature.
[0032] In some embodiments, the catheter assembly 34 may include a needle hub coupled to the proximal end of the catheter adapter 32 and an introducer needle (not shown) extending distally from the needle hub. In some embodiments, the needle hub and introducer needle may be detached from the catheter assembly 34 responsive to placement of the catheter 36 within the patient's vasculature, and the delivery device 10 may be coupled to the proximal end of the catheter adapter 32 after the needle hub and introducer needle are removed.
[0033] In some embodiments, the stopper 18 and the channel 20 may be oriented in various manners and angles within the barrel 14. For example, the channel 20 may be generally horizontally or vertically oriented within the barrel 14 when the delivery device 10 is coupled with a catheter adapter 32 positioned for insertion into a patient. In some embodiments, the barrel 14 and / or plunger 16 may be cylindrical, square, or other shapes.
[0034] In some embodiments, the barrel 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 pressed. In some embodiments, the liquid may exit the distal opening 26 of the syringe 12 in response to the plunger 16 being pressed. 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 may exit the distal opening 26 and / or such that the liquid may flow around the guidewire 22. In some embodiments, in response to the plunger 16 being pressed, the liquid may flow around the guidewire 22 and into and / or through the catheter assembly 34.
[0035] In some embodiments, the barrel 14 may be free of liquid. In some embodiments, the barrel 14 of the syringe 12 may include one or more vents 42, which may allow air to escape from the barrel 14 in response to the plunger 16 being pressed or moving in a distal direction. In some embodiments, the vents 42 may prevent air from entering the catheter assembly 34.
[0036] In some embodiments, the channel 20 may contact and support the guidewire 22. In some embodiments, the plunger 16 may be pushed or moved distally from a proximal position. In some embodiments, in response to the plunger 16 being pushed, the stopper 18 may be moved distally a first distance, the guidewire 22 may be moved through the channel 20, and the first end 24 of the guidewire 22 may be advanced distally a second distance, which may be greater than the first distance. In some embodiments, the second distance may be twice the first distance (a "1:2 advancement ratio") due to the U-shape of the channel 20. In some embodiments, the second distance may be at least twice the first distance. In some embodiments, a 1:2 advancement ratio between the delivery device 10, the stopper 18, and the first end 24 of the guidewire 22 (or another advancement ratio in which the second distance is greater than the first distance) may provide the guidewire 22 with an even longer reach while providing reliability and structural support as the guidewire 22 is advanced distally.
[0037] In some embodiments, a septum 44 may be disposed within the catheter adapter 32 and may be pierced in response to coupling of the delivery device 10 to the catheter adapter 32. In some embodiments, the distal end of the barrel 14 may include a secondary stopper 46, which may comprise rubber or other suitable material. In some embodiments, the secondary stopper 46 may prevent liquid from flowing out of the distal end of the barrel 14 or through the secondary stopper 46. In some embodiments, in response to the plunger 16 being pushed in a distal direction, the secondary stopper 46 may be configured to allow liquid to flow through the secondary stopper 46. In some embodiments, the secondary stopper 46 may contact the stopper 18 in response to the plunger 16 being moved to a distal position. In some embodiments, the distal position may correspond to a fully depressed position. In some embodiments, the secondary stopper 46 may be spaced from the stopper 18 in response to the plunger 16 being moved to a distal position. In some embodiments, the second end 28 may contact and / or be coupled to the secondary stopper 46.
[0038] 3A-3B, in some embodiments, the channel 20 may extend through the plunger 16 from one side to the other. Now referring to FIGS. 3C-3D, in some embodiments, the distal end 48 of the plunger 16 may include a smaller outer diameter than the proximal portion 50 of the plunger 16, which may contact the inside of the barrel 14. In some embodiments, the channel 20 may extend through the distal end 48 of the plunger 16, which may shorten the channel 20 to reduce contact and friction between the channel 20 and the guidewire 22. In some embodiments, the distal end 38 may include two opposing step surfaces, which may facilitate cutting away a portion of the distal end 38 to shorten the channel 20.
[0039] 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-like and / or compressible in response to the plunger 16 being pushed. In some embodiments, the housing 50 may comprise a 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 the first end 24 and the 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 contact between at least a portion of the guidewire 22 and a liquid 52, which may be disposed within the barrel 14. In some embodiments, in response to the plunger 16 being pushed or 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.
[0040] 5A-5B, in some embodiments, a biasing member 54 may be disposed within the barrel 14 distal to the stopper 18. In some embodiments, a proximal end of the biasing member 54 may be coupled to the plunger 16. In some embodiments, a distal end of the biasing member 54 may be coupled to the secondary stopper 46, the inner surface of the barrel 14, or another suitable location. In some embodiments, the biasing member 54 may comprise a coil spring, which may comprise a variable pitch or a uniform pitch. In some embodiments, the coil spring may comprise a compression spring. In some embodiments, the coil spring may comprise a smaller pitch near the distal tip 39 of the catheter 36 (see, e.g., FIGS. 1A-2B), which may prevent blood clots from entering the syringe 12 but allow blood to flow into the syringe 12.
[0041] In some embodiments, biasing member 54 may comprise a metal, an elastomer, or other suitable material. In some embodiments, biasing member 54 may reduce the force with which a practitioner presses plunger 16, which may reduce the chance of hemolysis.
[0042] 6A-6B, in some embodiments, a bias member 56 may be disposed within the barrel 14 proximate the stopper 18. In some embodiments, a distal end of the bias member 56 may be coupled to the stopper 18 or another suitable location. In some embodiments, a proximal end of the bias member 56 may be coupled to the plunger 16 or another suitable location. In some embodiments, the bias member 56 may be disposed between the U-shaped portion of the channel 20 and the distal end of the handle 19, for example as shown in FIGS. 11A-12B.
[0043] In some embodiments, the biasing member 56 may include a coil spring, which may include a variable pitch or a uniform pitch. In some embodiments, the coil spring may include a tension spring. In some embodiments, the coil spring may include a smaller pitch near the distal tip 39 of the catheter 36 (see, e.g., FIGS. 1A-2B), which may prevent clots from entering the syringe 12 but allow blood to flow into the syringe 12.
[0044] In some embodiments, the biasing member 56 may comprise a metal, an elastomer, or other suitable material. In some embodiments, the biasing member 56 may reduce the force with which a practitioner retracts or moves the plunger 16 in a proximal direction, which may reduce the chance of hemolysis. In some embodiments, the inner surface of the barrel 14 may include one or more protrusions 58, which may be configured to contact a portion of the plunger 16, such as the base 60, to prevent the plunger from being proximally removed from the barrel 14.
[0045] 7A, in some embodiments, the catheter system may include a syringe 16 and a syringe 62, both of which may be coupled to a Y-shaped adapter 64. In some embodiments, the Y-shaped adapter 64 may be coupled to the catheter adapter 32. In some embodiments, the Y-shaped adapter 64 may include three or more ports, one or more of which may include a Luer adapter or another suitable connector.
[0046] In some embodiments, the syringe 62 may be similar or identical in one or more features and / or operation to the syringe 16 of FIGS. 1-6. In some embodiments, the barrel 14 of the syringe 62 may be filled with a liquid 52, which may flow distally through the adapter 32 and the catheter assembly 34 in response to depression of the plunger 68 of the syringe 62. In some embodiments, the syringe 62 may be used to flush the catheter assembly 34 prior to and / or during advancement of the distal end of the guidewire 22 with the syringe 12. In some embodiments, the syringe 62 may be used to flush the catheter assembly 34 after blood withdrawal.
[0047] In some embodiments, the Y-shaped adapter 64 may be integrally formed with the syringe 12 and / or the syringe 62. Additionally or alternatively, in some embodiments, the Y-shaped adapter 64 may be integrally formed with the catheter adapter 32. In some embodiments, the plungers 16 of the syringe 12 and the syringe 62 may move independently of one another to allow the practitioner to control the amount of liquid 52 flushed into the vasculature separate from the insertion of the guidewire 22 into the vasculature. In some embodiments, the Y-shaped adapter 64 may be monolithically formed as a single unit with the syringe 12 and / or the syringe 62.
[0048] 7B, in some embodiments, the barrels 14 of the syringes 12 and 62 may be integrally formed, which may facilitate handling by the practitioner. In some embodiments, the plungers 16 of the syringes 12 and 62 may move independently of one another. In other embodiments, the plungers 16 of the syringes 12 and 62 may be coupled together such that they move together, which may facilitate handling and operation for the practitioner. Now referring to FIG. 7C, the plungers 16 of the syringes 12 and 62 may be coupled together, according to some embodiments.
[0049] In some embodiments, the syringe 12 (see FIGS. 7A-7C) may be replaced with another delivery device, which includes another guidewire advancement mechanism, such as, for example, a rotational advancement element or a linear advancement element. Referring now to FIG. 8, in some embodiments, the delivery device 70 may include an advancement element 72. In some embodiments, the advancement element 72 may include a tab or grip that may be moved by the practitioner to advance the guidewire 22 distally and / or retract the guidewire 22 proximally. In some embodiments, the advancement element 72 may be coupled to the proximal end of the guidewire 22. In some embodiments, the advancement element may be slidable along a slot 74 disposed within a housing 76, as shown in FIG. 8.
[0050] In some embodiments, the housing 76 may include a syringe portion 78, which may be the same or similar in one or more features and / or operation to the syringe 62 discussed with respect to FIGS. 7A-7C. In some embodiments, a wall 80 may separate the syringe portion 78 from the portion of the housing 76 that includes the guidewire 22. Thus, in some embodiments, the liquid within the syringe portion 78 may be separated within the delivery device 70 from the portion of the housing 76 that includes the guidewire 22. In some embodiments, the advancement element 72 and the plunger 16 of the syringe portion 78 may advance and / or retract independently of one another. In some embodiments, the distal end of the housing 76 may include a distal connector 30. In some embodiments, the syringe 62 (see, e.g., FIGS. 7A-7B) may be coupled to the proximal end of the housing 76, which may not include a syringe portion.
[0051] 7D , in some embodiments, the path of guidewire 22 as it moves distally may be generally straight. In some embodiments, distal port 77 and proximal port 79 of adapter 54 may be generally aligned with syringe 12 such that the path of guidewire 22 as it moves distally is generally straight. In some embodiments, movement of guidewire 22 in the distal direction following a generally straight path may be accomplished in a variety of ways, such as, for example, a different sized barrel 14 between syringe 12 and syringe 62.
[0052] 9, in some embodiments, the syringe 62 may be coupled to a housing 82, which may include the guidewire 22. In some embodiments, in response to the plunger 16 being pressed, the liquid 52 may flow distally through the housing 82, flushing the guidewire 22 into and past the distal tip of the catheter extending from the catheter adapter. In some embodiments, the proximal end of the guidewire 22 may include an enlarged diameter portion 83, which may hook onto a portion of the housing 82, such as a distal opening 84, or a portion of the catheter adapter to prevent further distal movement of the guidewire 22. In some embodiments, the distal end of the housing 82 may include a distal connector 86, which may be coupled to the catheter adapter. In some embodiments, the distal connector 86 may include a slip or thread male or slip or thread female Luer adapter, or another suitable connector.
[0053] 10, in some embodiments, the distal connector 30 of the syringe 12 may be coupled to a housing 88, which may be filled with a liquid 52. In some embodiments, in response to the plunger 16 being pressed, the liquid 52 may flow distally through a distal opening 90 of the housing 82 to flush the catheter assembly, which may be coupled to a distal connector 92 of the housing 82. In some embodiments, the distal connector 92 may include a slip or thread male or slip or thread female Luer adapter, or another suitable connector. In some embodiments, the housing 82 may prevent contact between the liquid 52 and the guidewire 22 before the plunger 16 is pressed. In some embodiments, in response to the plunger 16 being pressed, the guidewire 22 may be advanced distally through the housing 88 and through the catheter assembly.
[0054] 11A-11D, in some embodiments, the stopper 18 may not be coupled to the handle 19 of the plunger 16. In some embodiments, in response to the handle 19 being in a proximal position, the stopper 18 may be proximal to the distal end of the handle 19, as illustrated in, for example, FIGS. 11A-11B. In some embodiments, in response to the handle 19 being moved from the proximal position to the distal position, the stopper 18 may be moved to the distal end. In some embodiments, in response to the handle 19 being retracted proximally after being moved from the proximal position to the distal position, the stopper 18 may remain, as illustrated in, for example, FIGS. 11C-11D. In these embodiments, the channel 20 may be disposed within the distal portion of the handle 19 and the stopper 18. In some embodiments, after blood collection is completed, the handle 19 may be retracted proximally, but the stopper 18 may remain to prevent blood from entering the syringe 12.
[0055] 12A-12B, in some embodiments, the plunger 16 may be pushed or moved distally from a proximal position. In some embodiments, in response to the plunger 16 being pushed a first distance distally, the guidewire 22 may move through the channel 20 and the first end 24 of the guidewire 22 may be advanced distally a second distance, which may be greater than the first distance. In some embodiments, the guidewire 22 may form one or more loops when the plunger 16 is in the proximal position. In these embodiments, the guidewire 22 may include multiple bends or U-shaped portions. In some embodiments, the guidewire 22 may include a first U-shaped portion 94 and a second U-shaped portion 96, as illustrated, for example, in FIGS. 12A-12B. In some embodiments, the second end 28 may be coupled to the plunger 16, an inner surface of the barrel 14, or another suitable location. In some embodiments, due to the multiple bends and looped configuration of the guidewire 22, the second distance may be greater than twice the first distance.
[0056] 13A-13B, in some embodiments, the syringe 12 may include an outer plunger 98 and an inner plunger 100, which may be disposed within the outer plunger 98 and movable in proximal and distal directions relative to the outer plunger 98. In some embodiments, the outer plunger 98 may be disposed within the barrel 14 and movable in proximal and distal directions relative to the barrel 14. In some embodiments, the plunger 16 may be coupled to a distal end of the outer barrel 98. In some embodiments, the channel 20 may be disposed at a distal end of the inner barrel 100.
[0057] In some embodiments, the outer plunger 98 and the inner plunger 100 may be disposed in a proximal position, for example, as illustrated in FIG. 13A. In some embodiments, the outer plunger 98 and the inner plunger 100 may be simultaneously advanced in a distal direction from a proximal position. In response to the outer plunger 98 and the inner plunger 100 being simultaneously advanced in a distal direction, the guidewire 22 and the stopper 18 may be advanced distally. In some embodiments, the stopper 18 may be proximal to the distal end of the inner barrel 100. In some embodiments, blood collection may occur after the outer plunger 98 and the inner plunger 100 are simultaneously advanced in a distal direction. In some embodiments, in response to blood collection being completed, the inner plunger 100 may be retracted in a proximal direction, for example, as illustrated in FIG. 13B, and the outer plunger 98 may remain in place. In some embodiments, the stopper 18 disposed in the distal end of the barrel 14 may prevent blood from entering the syringe 12.
[0058] 14 , in some embodiments, an 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 septum 104 may be disposed between the extension tube 102 and the proximal portion of the barrel 14. In some embodiments, the guidewire 22 may extend through the septum 104.
[0059] In some embodiments, a practitioner can collect a blood sample from a patient by inserting a catheter (see, e.g., catheter 36 in FIGS. 1A-2B) into the vascular system and withdrawing plunger 16 in a proximal direction. In some embodiments, a practitioner can collect blood via extension tube 38 (see, e.g., FIGS. 1A-2B) or extension tube 102.
[0060] 15A-15C, in some embodiments, the blunt cannula 106 of the connector 30 may form the distal opening 26. In some embodiments, a cap 108 may surround the blunt cannula 106. In some embodiments, the cap 108 may include one or more protrusions 110, which may facilitate grasping of the cap 108 by a practitioner prior to removal of the cap 108 from the blunt cannula 106 by the practitioner. In some embodiments, as illustrated, for example, in FIG. 15B, the distal end 112 of the cap 108 may be closed, which may prevent the guidewire 22 from migrating to the distal end of the blunt cannula 106 during shipping and / or priming. In some embodiments, the cap 108 may include one or more vent holes extending through the cap 108 proximate the distal end 112.
[0061] All examples and conditional statements described herein are intended for educational purposes to help the reader understand the concepts contributed by the inventor to promote the present invention and technology, and are not to be construed as being limited to such specifically described examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made therein without departing from the spirit and scope of the present invention.
Claims
1. 1. A delivery device for delivering a guidewire into a catheter assembly, the delivery device comprising: a syringe comprising a barrel and a plunger movable within the barrel, the plunger comprising a handle and a stopper coupled to a distal end of the handle, the stopper comprising a channel; a guidewire disposed within the barrel and extending through the channel, wherein in response to the plunger being depressed, the guidewire moves through the channel such that a first end of the guidewire is advanced distally and a second end of the guidewire is anchored within the delivery device; A delivery device comprising:
2. 2. The delivery device of claim 1, wherein the barrel contains a liquid, and in response to the plunger being depressed, the liquid exits a distal opening of the syringe, the diameter of the distal opening of the syringe being greater than an outer diameter of the guidewire.
3. 10. The delivery device of claim 1, wherein air is disposed within the barrel, the barrel comprising a plurality of vents, and wherein the air exits the vents in response to the depression of the plunger.
4. 2. The delivery device of claim 1, wherein in response to the depression of the plunger, the stopper is moved a first distance in the distal direction and the first end of the guidewire is advanced a second distance in the distal direction, the second distance being greater than the first distance.
5. 2. The delivery device of claim 1, wherein the barrel contains a liquid, the syringe further comprising a flexible housing disposed within the barrel, the flexible housing preventing contact between the liquid and at least a portion of the guidewire, the portion of the guidewire being surrounded by the flexible housing, and the housing configured to compress in response to the plunger being depressed.
6. 10. The delivery device of claim 1, wherein the syringe further comprises a biasing member disposed within the barrel distal to the stopper, the biasing member being compressed in response to the plunger being depressed.
7. 10. The delivery device of claim 1, wherein the syringe further comprises a biasing member disposed between the stopper and the handle, the biasing member expanding in response to retraction of the handle.
8. The delivery device of claim 1 , further comprising a housing coupled to the distal end of the syringe, the housing containing a saline solution, and the guidewire being disposed entirely at a proximal end of the housing.
9. The delivery device of claim 1 , wherein the guidewire forms one or more loops.
10. 1. A delivery device for delivering a guidewire into a catheter assembly, the delivery device comprising: a syringe comprising a barrel and a plunger movable within the barrel, the plunger comprising a handle and a stopper disposed at a distal end of the handle, the syringe further comprising a channel, a U-shaped portion of the channel disposed within the handle and another portion of the channel extending through the stopper; a guidewire disposed within the barrel and extending through the channel, wherein in response to being pushed distally of the handle, the stopper moves distally to a distal position, the guidewire moves through the channel, a first end of the guidewire is advanced in the distal direction, and a second end of the guidewire is secured within the delivery device, and in response to retraction of the handle proximally, the stopper remains at the distal position, the guidewire moves through the channel, and the first end of the guidewire is retracted in the proximal direction; A delivery device comprising:
11. 11. The delivery device of claim 10, wherein the barrel contains a liquid, and in response to the depression of the plunger, the liquid exits a distal opening of the syringe, the diameter of the distal opening of the syringe being greater than an outer diameter of the guidewire.
12. 11. The delivery device of claim 10, wherein air is disposed within the barrel, the barrel comprising a plurality of vents, and wherein the air exits the vents in response to the depression of the plunger.
13. 11. The delivery device of claim 10, wherein in response to the depression of the plunger, the stopper is moved a first distance in the distal direction and the first end of the guidewire is advanced a second distance in the distal direction, the second distance being greater than the first distance.
14. 11. The delivery device of claim 10, wherein the barrel contains a liquid, the syringe further comprising a flexible housing disposed within the barrel, the flexible housing preventing contact between the liquid and at least a portion of the guidewire, the portion of the guidewire being surrounded by the flexible housing, and the housing configured to compress in response to the plunger being depressed.
15. 11. The delivery device of claim 10, wherein the syringe further comprises a biasing member disposed within the barrel distal to the stopper, the biasing member being compressed in response to the plunger being depressed.
16. 11. The delivery device of claim 10, wherein the syringe further comprises a biasing member disposed between the U-shaped portion and the handle, the biasing member expanding in response to retraction of the handle in the proximal direction.
17. 1. A delivery device for delivering a guidewire into a catheter assembly, the delivery device comprising: a first syringe comprising a first barrel and a first plunger movable within the first barrel, the first plunger comprising a first handle and a first stopper coupled to a distal end of the first handle, the first stopper comprising a channel, air disposed within the first barrel, the first barrel comprising a plurality of vent holes, the air exiting the vent holes in response to the pressing of the first plunger; a guidewire disposed within the first barrel and extending through the channel, wherein in response to the first plunger being depressed, the guidewire moves through the channel such that a first end of the guidewire is advanced in the distal direction and a second end of the guidewire is secured within the delivery device; and a second syringe comprising a second barrel and a second plunger movable within the second barrel, the second plunger comprising a second handle and a second stopper coupled to a distal end of the second handle, the second barrel containing a liquid, the liquid exiting a distal opening of the second syringe in response to the depression of the second plunger; an adapter having a first port, a second port, and a third port, the first port configured to couple to a distal end of the first syringe, the second port configured to couple to a distal end of the second syringe, and the third port configured to couple to the catheter assembly; A delivery device comprising:
18. 20. The delivery device of claim 17, wherein the first barrel and the second barrel are integrally formed.
19. The delivery device of claim 17 , wherein the first plunger is coupled to the second plunger.
20. 20. The delivery device of claim 17, wherein the first port is integrally formed with the first syringe or the second port is integrally formed with the second syringe.
Citation Information
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