Syringe-based delivery device for vascular access instrument
By using a syringe-based delivery device and guiding features, needleless access to the patient's vascular system via peripheral IV catheters is achieved, solving the problem of difficult blood sample collection after prolonged catheter placement and reducing needle prick pain and costs.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2019-11-25
- Publication Date
- 2026-03-27
AI Technical Summary
Existing peripheral IV catheters are difficult to use conveniently for blood sample collection after prolonged indwelling, resulting in additional needle prick pain and increased material costs.
Using a syringe-based delivery device, the device enables needle-free access to the patient's vascular system via the cooperation of a guide feature and a plunger. It incorporates guidewire support to reduce venous trauma and utilizes fluid flushing and the fluid path of the catheter assembly.
It achieves needle-free access, reducing needle prick pain and material costs, and improving the convenience and safety of blood sample collection.
Smart Images

Figure CN115845222B_ABST
Abstract
Description
[0001] Divisional
[0002] This patent application is a divisional patent application.
[0003] The parent application of this divisional patent application, namely: Matter, Firm File No. IIM211329 , is an invention patent application with international application number PCT / US2019 / 063063, Chinese national application number 201980078454.1, and invention title “Syringe-based delivery device for vascular access instrument” having an international filing date of November 25, 2019. BACKGROUND
[0004] Catheters are commonly used for various infusion therapies. For example, catheters can be used to infuse fluids, such as saline solutions, various medications, and total parenteral nutrition, into a patient. Catheters can also be used to withdraw blood from a patient.
[0005] One common type of catheter is an over-the-needle peripheral intravenous (“IV”) catheter. As the name implies, an over-the-needle catheter can be installed over an introducer needle having a sharp distal tip. The catheter and introducer needle can 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 facing upward and away from the patient’s skin. The catheter and introducer needle are typically inserted into the patient’s vasculature at a small angle through the skin.
[0006] To verify proper placement of the introducer needle and / or catheter in the blood vessel, a clinician typically confirms the presence of a “flashback” of blood in a flashback chamber of the catheter assembly. Once the placement of the needle is confirmed, the clinician can temporarily occlude flow in the vasculature and remove the needle, leaving the catheter in place for future blood withdrawal or fluid infusion.
[0007] Blood withdrawal using a peripheral IV catheter can be difficult for several reasons, particularly when the catheter is left in place for more than one day. For example, as a catheter remains inserted into a patient for an extended period of time, the catheter or vein can become more susceptible to narrowing, collapse, kinking, occlusion by debris (e.g., fibrin or platelet clots), and adhesion of the catheter tip to the vasculature. As a result, catheters are typically used to collect blood samples at the time of catheter placement, but are used much less frequently to collect blood samples during the catheter’s dwell period. Thus, when a blood sample is needed, an additional needle stick is required to provide venous access for blood collection, which can be painful for the patient and result in higher material costs. Accordingly, there is a need for a catheter system and method that facilitates placement of a blood sample instrument, such as a catheter and a probe, in a patient’s vasculature without requiring an additional needle stick.
[0008] The subject matter claimed herein is not limited to implementations that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is provided only to illustrate one example technology area where some implementations described herein can be practiced. SUMMARY
[0009] The present disclosure generally relates to a syringe-based delivery device for delivering a vascular access instrument into a catheter assembly and / or a patient's vasculature, and related systems and methods. In some embodiments, the delivery device can include a syringe having a barrel and a plunger movable within the barrel. In some embodiments, the delivery device can include a guide feature that can be disposed within the barrel and / or coupled to the plunger. In some embodiments, the guide feature can move with the plunger. In some embodiments, the guide feature can include a channel that can be generally U-shaped. In some embodiments, the guide feature and the channel can be oriented in various ways within the barrel. For example, the channel can be oriented in a horizontal direction or a vertical direction within the barrel.
[0010] In some embodiments, the delivery device can include an instrument disposed within the barrel and extending through the guide feature. For example, the instrument can extend through the channel. In some embodiments, in response to the plunger being depressed or the plunger moving distally, the guide feature can move a first distance in a distal direction, the instrument can move through the channel, and a first end of the instrument can be advanced a second distance in the distal direction, which can be greater than the first distance. In some embodiments, the second distance can be at least twice the first distance.
[0011] In some embodiments, in response to the plunger being partially and / or fully depressed in the distal direction within the barrel, the first end of the instrument can be advanced beyond a distal end of the syringe in the distal direction. In some embodiments, a second end of the instrument can be fixed. In some embodiments, the second end of the instrument can be fixed within the barrel. In some embodiments, a catheter adapter of the catheter assembly can be coupled to the syringe.
[0012] In some embodiments, a needleless connector can be disposed between the syringe and the catheter adapter and can connect the syringe to the catheter adapter. More specifically, in some embodiments, a distal end of the needleless connector can be coupled to the catheter adapter of the catheter assembly, and a proximal end of the needleless connector can be coupled to the syringe. In some embodiments, a distal end of the syringe can include a connector that can be configured to be coupled to the catheter adapter and / or the proximal end of the needleless connector. In some embodiments, an interface adapter can be disposed between the syringe and the catheter adapter and can connect the syringe to the catheter adapter. In some embodiments, a second end of the instrument can be fixed within the interface adapter.
[0013] In some embodiments, the barrel can include a liquid, such as saline or another suitable flushing liquid. In some embodiments, the liquid can completely fill the barrel. In some embodiments, the liquid can be expelled out of the distal opening of the syringe in response to depression of the plunger. In some embodiments, the diameter of the distal opening of the syringe can be larger than the outer diameter of the instrument. In some embodiments, the liquid can flow around the instrument and into and / or through the catheter assembly in response to depression of the plunger.
[0014] In some embodiments, the barrel can not include a liquid, but the syringe can be used to deliver the instrument to the catheter assembly. In these and other embodiments, the distal opening of the syringe can include a septum to form a seal between the distal opening of the syringe and the instrument, and the barrel or stopper can include a vent for air to escape during advancement of the plunger.
[0015] In some embodiments, the instrument can include a probe (which can include a sensor), a light pipe for sterilization, or another suitable instrument. In some embodiments, the instrument can include a catheter. In these and other embodiments, the syringe can include an extension tube that can extend outwardly from the distal portion of the syringe. In some embodiments, the second end of the instrument can be coupled to the extension tube. In some embodiments, blood collected from the patient can flow from the second end of the instrument into the extension tube.
[0016] In some embodiments, a guidewire can be disposed within the instrument. In some embodiments, the guidewire and the instrument can move through the passage in response to the plunger being depressed in the distal direction within the barrel. In some embodiments, the first end of the guidewire can be advanced in the distal direction in response to the plunger being depressed in the distal direction within the barrel. In some embodiments, the guide feature can move in the distal direction a first distance and the first end of the guidewire can be advanced in the distal direction a second distance in response to depression of the plunger. In some embodiments, the second distance can be greater than the first distance. In some embodiments, the second distance can be at least twice the first distance.
[0017] In some embodiments, the first end of the guidewire can be advanced in the distal direction beyond the distal end of the syringe in response to the plunger being partially and / or fully depressed. In some embodiments, the second end of the guidewire can be fixed. For example, the second end of the guidewire can be fixed within the barrel or the interface adapter.
[0018] In some embodiments, the delivery device can include a support tube that can extend from and be coupled to the guide feature. In some embodiments, the guide feature can move in the distal direction a first distance, the instrument can move through the support tube, the first end of the instrument can be advanced in the distal direction a second distance, and the first end of the support tube can be advanced in the distal direction the first distance in response to depression of the plunger. In these embodiments, the second distance can be greater than the first distance.
[0019] In some embodiments, the delivery device can allow the instrument to access the vasculature of a patient through another vascular access device, such as a catheter assembly that can be inserted into the vasculature of a patient. In some embodiments, when the instrument is introduced into the catheter assembly through the delivery device, the instrument can access a fluid path of the catheter assembly and / or the instrument can extend through the catheter assembly and access the vasculature of the patient. In some embodiments, the catheter assembly can include a catheter adapter and another catheter that can extend distally from the catheter adapter. In some embodiments, a proximal end of the other catheter can be secured within the catheter adapter.
[0020] In some embodiments, the instrument can be coupled to the plunger and can be movable along the plunger to a deployed position. In some embodiments, the instrument can extend distally into the barrel. In some embodiments, a distal end of the instrument can be configured to be advanced distally of a distal end of the syringe.
[0021] In some embodiments, the plunger can include a rib. In some embodiments, the instrument can be coupled to the rib and can be movable along the rib. In some embodiments, the plunger can include a slot. In these and other embodiments, the instrument can be disposed within the barrel and coupled to an advancement tab movable along the slot. In some embodiments, the plunger can include a stopper. In some embodiments, in response to the plunger being moved to the deployed position, the instrument can be movable through the stopper.
[0022] In some embodiments, the syringe can include an outer barrel, an inner barrel, an elongated body movable within the inner barrel, and a plunger head disposed within the inner barrel. In some embodiments, a distal end of the elongated body can be coupled to the plunger head. In some embodiments, in response to the coupling of the elongated body to the plunger head, the elongated body and the plunger head can be configured to be advanced distally together to expel liquid from the inner barrel through a distal opening of the syringe.
[0023] In some embodiments, the instrument can extend from the distal end of the elongated body and through the plunger head. In some embodiments, in response to the advancement of the elongated body in a distal direction within the inner barrel, a distal end of the instrument can be advanced in the distal direction. In some embodiments, in response to the coupling of the elongated body to the plunger head, the elongated body and the plunger head can be configured to be retracted proximally together to expel liquid from the inner barrel into the outer barrel.
[0024] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the application as claimed. It should be understood that various embodiments are not limited to the arrangements and instrumentalities shown in the attached drawings. It should also be understood that the embodiments can be combined or other embodiments can be utilized and structural changes can be made without departing from the scope of the various embodiments of the present application unless otherwise specified. Accordingly, the following detailed description is not limiting. BRIEF DESCRIPTION OF DRAWINGS
[0025] Example embodiments will be described and explained with additional specificity and detail by the use of the accompanying drawings in which:
[0026] Figure 1A is a top view of an example delivery device coupled to an example catheter assembly according to some embodiments, showing an example plunger of the delivery device in a proximal position;
[0027] Figure 1B is a cross-sectional view of the delivery device of Figure 1A coupled to the catheter assembly of Figure 1A , showing the plunger in the proximal position;
[0028] Figure 1C is a cross-sectional view of the delivery device of Figure 1A along line 1C-1C of Figure 1A ;
[0029] Figure 1D is another cross-sectional view of the delivery device of Figure 1A along line 1C-1C of Figure 1A ;
[0030] Figure 1E is a cross-sectional view of a distal end of an example catheter of the catheter assembly of Figure 1A according to some embodiments;
[0031] Figure 1F is a side view of another example delivery device coupled to a catheter assembly according to some embodiments, showing an example channel oriented vertically within an example barrel;
[0032] Figure 1G is a cross-sectional view of the delivery device of Figure 1F , showing the channel oriented vertically within the barrel;
[0033] Figure 1H is a cross-sectional view of the delivery device of Figure 1F along 1H-1H line of Figure 1F ;
[0034] Figure 2Ais a delivery device coupled to a catheter assembly according to some embodiments Figure 1A is a delivery device coupled to a catheter assembly according to some embodiments Figure 1A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0035] is a delivery device coupled to a catheter assembly according to some embodiments Figure 2B is a delivery device coupled to a catheter assembly according to some embodiments Figure 1A is a delivery device coupled to a catheter assembly according to some embodiments Figure 1A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0036] is a delivery device coupled to a catheter assembly according to some embodiments Figure 3A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0037] is a delivery device coupled to a catheter assembly according to some embodiments Figure 3B is a delivery device coupled to a catheter assembly according to some embodiments Figure 3A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0038] is a delivery device coupled to a catheter assembly according to some embodiments Figure 4A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0039] is a delivery device coupled to a catheter assembly according to some embodiments Figure 4B is a delivery device coupled to a catheter assembly according to some embodiments Figure 4A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0040] is a delivery device coupled to a catheter assembly according to some embodiments Figure 5A is a delivery device coupled to a catheter assembly according to some embodiments Figure 4A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0041] is a delivery device coupled to a catheter assembly according to some embodiments Figure 5B is a delivery device coupled to a catheter assembly according to some embodiments Figure 5A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0042] is a delivery device coupled to a catheter assembly according to some embodiments Figure 6A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0043] is a delivery device coupled to a catheter assembly according to some embodiments Figure 6B is a delivery device coupled to a catheter assembly according to some embodiments Figure 6A is a delivery device coupled to a catheter assembly according to some embodiments is a delivery device coupled to a catheter assembly according to some embodiments
[0044] is a delivery device coupled to a catheter assembly according to some embodiments Figure 6C is a delivery device coupled to a catheter assembly according to some embodiments Figure 6A is a delivery device coupled to a catheter assembly according to some embodiments Figure 6A is a delivery device coupled to a catheter assembly according to some embodiments
[0045] Figure 6D is a top perspective view of a delivery device of Figure 6A
[0046] Figure 6E is a top perspective view of a delivery device of Figure 6A
[0047] Figure 7A is a top perspective view of a delivery device of Figure 6A
[0048] Figure 7B is a top perspective view of a delivery device of Figure 7A
[0049] Figure 7C is a top perspective view of a delivery device of Figure 7A
[0050] Figure 8A is a top perspective view of a delivery device of
[0051] Figure 8B is a top perspective view of a delivery device of Figure 8A
[0052] Figure 8C is a top perspective view of a delivery device of Figure 8A
[0053] Figure 8D is a top perspective view of a delivery device of Figure 8A
[0054] Figure 8E is a top perspective view of a delivery device of Figure 8A
[0055] Figure 9A is a top perspective view of a delivery device of
[0056] Figure 9B According to some embodiments Figure 9A A cross-sectional view of the conveying device, showing the plunger in the partially advanced position;
[0057] Figure 9C According to some embodiments Figure 9A A cross-sectional view of the conveying device, showing the plunger in a partially retracted position;
[0058] Figure 10A This is a cross-sectional view of another example delivery device according to some embodiments, showing an example plunger in a proximal position;
[0059] Figure 10B According to some embodiments Figure 10A A cross-sectional view of the conveying device, showing the plunger in the distal position;
[0060] Figure 10C According to some embodiments Figure 10A A cross-sectional view of the delivery device, showing an example extension tube integrated within the plunger;
[0061] Figure 11 This is a flowchart illustrating example methods according to some embodiments. Detailed Implementation
[0062] Now for reference Figures 1A-1B 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. Figures 1A-1B The barrel 14 of a syringe 12 in a proximal position is shown according to some embodiments. In some embodiments, the delivery device 10 may include a guide feature 18 disposed within the barrel 14 and / or coupled to a plunger 16. In some embodiments, the guide feature 18 may be movable with the plunger 16. In some embodiments, the guide feature 18 may include a channel 20, which may be generally U-shaped. In other embodiments, a portion 17 of the channel 20 may be removed, and the channel 20 may include a generally semi-circular shape.
[0063] In some embodiments, the distal end of the plunger 16 can include a stopper 21, which can include rubber or other suitable material. In some embodiments, the guide feature 18 can move with the plunger 16. For example, the guide feature 18 can be coupled to the stopper 21 and can move proximally and / or distally with the plunger 16. As another example, the stopper 21 can include the guide feature 18 and the guide feature 18 can move proximally and distally with the plunger 16. More specifically, in some embodiments, the channel 20 can be disposed within the stopper 21. In some embodiments, in response to proximal movement of the plunger 16, the guide feature 18 can move proximally and the instrument 22 can be proximally retracted or withdrawn.
[0064] In some embodiments, the delivery device 10 can include an instrument 22, which can be disposed within the barrel 14 and can extend through the guide feature 18. For example, the instrument can extend through the channel 20. In some embodiments, the instrument 22 can include a probe (which can include a sensor), a light pipe for sterilization, or other suitable instrument. In some embodiments, the instrument 22 can include a catheter. In these and other embodiments, the syringe 12 can include an extension tube 24, which can extend outwardly from a distal portion of the syringe 12, such as the barrel 14. In some embodiments, the distal end of the barrel 14 can be proximate to the distal connector 34. In some embodiments, the barrel 14 can include a uniform inner diameter.
[0065] In some embodiments, a blood collection device 23 can be coupled to the extension tube 24. In some embodiments, the blood collection device 23 can include a vacuum tube, a test tube, or a syringe. In some embodiments, the blood collection device can include an adapter, which can be configured to hold a test tube, for example, as shown in Figures 1A-1B
[0066] In some embodiments, in response to the plunger 16 being partially and / or fully depressed in the distal direction within the barrel 14, the first end 25 of the instrument 22 can be advanced in the distal direction beyond the distal opening 46 of the syringe 12. In some embodiments, the second end 28 of the instrument 22 can be fixed. In some embodiments, the second end 28 of the instrument 22 can be fixed within the barrel 14 or the distal connector 34. In some embodiments, the second end 28 of the instrument 22 can be coupled to the extension tube 24, such that blood collected from the patient via the catheter assembly 30 can flow from the second end 28 of the instrument 22 into the extension tube 24. In some embodiments, the first end 25 of the instrument 22 can be blunt and / or tapered.
[0067] In some embodiments, the catheter adapter 32 of the catheter assembly 30 can be coupled to the syringe 12. More specifically, in some embodiments, the distal end 26 of the syringe 12 can include a distal connector 34, which can be configured to couple to a proximal end of the catheter adapter 32. In some embodiments, the distal connector 34 can include a luer adapter, such as a slip or threaded male or female luer adapter, or another suitable connector.
[0068] In some embodiments, a needleless connector can connect the syringe 12 to the catheter adapter 32. More specifically, in some embodiments, the distal connector 34 can be configured to couple to a proximal end of the needleless connector. In some embodiments, a distal end of the needleless connector can couple to a proximal end of the catheter adapter 32. In some embodiments, the needleless connector can include a luer adapter, such as a male luer adapter or a female luer adapter, or any other suitable connector. In some embodiments, the needleless connector can include a pro re nata ("PRN") connector. In some embodiments, the needleless connector can include a SMARTSITE® needleless connector, available from Baxter Healthcare Corporation. TM In some embodiments, the needleless connector can include a Q-SYTE® needleless connector, available from Baxter Healthcare Corporation. TM In some embodiments, the needleless connector can include an INTERLINK® luer activated split septum, available from Baxter. TM In some embodiments, the needleless connector can include a SMARTSITE® needleless system or another suitable needleless connector.
[0069] In some embodiments, the catheter assembly 30 can include a catheter 36, which can be secured within the catheter adapter 32 and can extend distally from the catheter adapter 32. In some embodiments, the catheter 36 can include a peripheral intravenous catheter, which can be left in place within the vasculature of a patient. In some embodiments, the catheter adapter 32 can be integrated, have an integrated extension tube (not shown), or be non-integrated.
[0070] In some embodiments, the delivery device 10 can allow the instrument 22 to access the vasculature of a patient through the catheter 36, which can be inserted into the vasculature of a patient. In some embodiments, when the instrument 22 is introduced into the catheter assembly via the delivery device 10, the instrument can access the fluid path of the catheter assembly 30 and / or the instrument 22 can extend through the catheter assembly 30 and access the vasculature of a patient.
[0071] In some embodiments, the catheter assembly 30 may include a needle hub coupled to the proximal end of the catheter adapter 32 and an introduction needle (not shown) extending distally from the needle hub. In some embodiments, the needle hub and the introduction needle may be removed from the catheter assembly 30 in response to placement of the catheter 36 within the patient's vascular system, and after the needle hub and the introduction needle are removed, the delivery device 10 may be coupled to the proximal end of the catheter adapter 32.
[0072] In some embodiments, the guide feature 18 and the channel 20 may be oriented in various ways and at various angles within the tube 14. For example, when the delivery device 10 is coupled to a catheter adapter 32 positioned for insertion into a patient, the channel 20 may be oriented generally horizontally or vertically within the tube 14.
[0073] In some embodiments, the cylinder 14 may include a liquid 38, such as saline or other suitable flushing liquid. In some embodiments, the liquid 38 may completely fill the cylinder 14. In some embodiments, the liquid 38 may be used to flush all or part of the conduit assembly 30, as will be explained in further detail.
[0074] In some embodiments, the guidewire 40 may be disposed within the instrument 22. In some embodiments, in response to the plunger 16 being partially and / or fully depressed, the first end 42 of the guidewire 40 may be advanced distally beyond the distal end of the syringe 12. In some embodiments, the second end 44 of the guidewire 40 may be fixed. For example, the second end 44 of the guidewire 40 may be fixed within the barrel 14.
[0075] In some embodiments, the guidewire 40 can be used to facilitate the placement of the device 22 within the patient's vascular system, which can result in less venous-related trauma. In some embodiments, the guidewire 40 can support the device 22, such as a catheter, during advancement to prevent it from being damaged when passing through a second catheter (e.g., catheter 36, as shown in the image). Figures 1A-1B (As shown) Collapse or buckling during advancement. In some embodiments, the guidewire 40 may support all or part of the instrument 22 to improve structural reliability, provide sufficient blood collection filling time performance, maintain an acceptable risk of hemolysis, and minimize the risk of kinking of the instrument 22. In some embodiments, after blood sampling is completed, the guidewire 40 and instrument 22 may be enclosed within the delivery device 10. It should be understood that in some embodiments, the delivery device 10 may not include the guidewire 40.
[0076] Now for reference Figure 1CIn some embodiments, the channel 20 can contact and support the instrument 22. In some embodiments, the shape of the channel 20 can be configured to reduce the risk of kinking or bending of the instrument 22 as the instrument 22 is moved through the channel. In some embodiments, the outer diameter of the guide wire 40 can be less than the inner diameter of the instrument 22, such that fluid can readily flow through the instrument 22. In some embodiments, the curvature of the U-shape can vary depending on, for example, the bend radius of the material that makes up the instrument 22. In some embodiments, the curvature of the U-shape can be configured to prevent kinking or damage to the instrument 22. In some embodiments, the channel 20 can include one or more protrusions 27, such as lips or detents, which can help secure the instrument 22 within the channel 20.
[0077] Referring now to Figure 1D , as an alternative to the guide feature configuration shown in Figure 1C , in which the guide feature 18 spans only partially across the lumen of the barrel 14, in some embodiments the guide feature 18 can span the entire lumen of the barrel 14. More specifically, in some embodiments the guide feature 18 can contact the entire inner surface of the barrel at a cross-section of the barrel, for example as shown in Figure 1D .
[0078] Referring now to Figures 1F-1H , in some embodiments the channel 20 can be oriented vertically within the syringe 12, as opposed to horizontally, for example as shown in Figures 1A-1B . In some embodiments the guide feature 18 can span the entire lumen of the barrel 14 and contact the entire inner surface of the barrel at a cross-section of the barrel, for example as shown in Figures 1F-1G . In other embodiments the guide feature 18 can span only partially across the lumen of the barrel 14. Figure 1H
[0079] Referring now to Figures 2A-2B , in some embodiments the plunger 16 can be depressed or moved in a distal direction from a proximal position. In some embodiments, in response to the depression of the plunger 16, the guide feature 18 can be moved in a distal direction a first distance, the instrument 22 can be moved through the channel 20, and the first end 25 of the instrument 22 can be advanced in the distal direction a second distance, which can be greater than the first distance. In some embodiments, due to the U-shape of the channel 20, the second distance can be at least twice the first distance ("1 :2 advancement ratio"). In some embodiments, the 1 :2 advancement ratio (or another advancement ratio in which the second distance is greater than the first distance) between the guide feature 18 and the first end 25 of the instrument 22 as the instrument 22 is advanced distally can provide reliability and structural support while also providing an instrument 22 with a long reach.
[0080] In some embodiments, liquid 38 can exit distal opening 46 of syringe 12 in response to depression of plunger 16. In some embodiments, a diameter of distal opening 46 of syringe 12 can be greater than an outer diameter of instrument 22. In some embodiments, liquid 38 can flow around instrument 22 and into and / or through catheter assembly 30 in response to depression of plunger 16.
[0081] In some embodiments, instrument 22 can include a guidewire 40 and / or a multi-diameter catheter, such as described in U.S. Patent Application No. 62 / 660,646, filed April 20, 2018, entitled “MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS,” which is incorporated by reference herein. In some embodiments, a multi-diameter catheter can allow for increased blood flow rate during blood collection. In some embodiments, a distal end of guidewire 40 can be disposed proximal to a transition of the multi-diameter catheter to allow fluid to flow in an annular space between an outer surface of guidewire 40 and an inner surface of the multi-diameter catheter.
[0082] In some embodiments, in response to plunger 16 being depressed in a distal direction within barrel 14, guidewire 40 can move through passage 20 within instrument 22 and first end 42 of guidewire 40 can be advanced in a distal direction. In some embodiments, in response to plunger 16 being depressed, guide feature 18 can move a first distance in a distal direction and first end 42 of guidewire 40 can be advanced a second distance in a distal direction. In some embodiments, the second distance can be greater than the first distance. In some embodiments, the second distance can be at least twice the first distance.
[0083] Referring back to Figure 1E In some embodiments, distal end 48 of catheter 36 can include one or more flow holes 50 extending through a wall of catheter 36. In some embodiments, liquid 38 can flow out of flow holes 50 in response to plunger 16 being depressed.
[0084] Referring now to Figures 3A-3B In some embodiments, delivery device 10 can include a support tube 54 that can extend from guide feature 18. In some embodiments, support tube 54 can be fixed to guide feature 18. In some embodiments, in response to plunger 16 being depressed, guide feature 18 can move a first distance in a distal direction, instrument 22 can move through support tube 54, and first end 56 of support tube 54 can be advanced a first distance in a distal direction. In some embodiments, support tube 54 can include a uniform inner diameter and / or a uniform outer diameter along all or a portion of a length of support tube 54.
[0085] In some embodiments, when the delivery device 10 includes the support tube 54, the instrument 22 can include a catheter constructed of a material that is softer than polyimide, which is less damaging to the walls of a vein. In these and other embodiments, the instrument 22 can include a tube constructed of one or more of polyurethane, silicone, thermoplastic elastomer ("TPE"), thermoplastic polyurethane ("TPU"), and another suitable compliant material.
[0086] In some embodiments, the support tube 54 can include an inner diameter that is larger than the outer diameter of the instrument 22, such that the instrument 22 can be easily moved through the support tube 54. In some embodiments, the support tube 54 can provide support to the first end 25 or free end of the instrument 22. In some embodiments, in response to the depression of the plunger 16 and the movement of the guide feature 18 a first distance, the first end 56 of the support tube 54 can be advanced in the distal direction a distance equal to the first distance ("1 : 1 advancement ratio"), while the first end 25 of the instrument 22 can be advanced a distance greater than the first distance, such as twice the first distance ("1 :2 advancement ratio"). In some embodiments, the different advancement ratios of the guide feature 18 relative to the first end 25 and the guide feature 18 relative to the support tube 54 can result in the support tube 54 not being advanced distally beyond a portion of the instrument 22, and the portion of the instrument 22 being advanced distally through the catheter assembly 30 and into the vasculature. In these and other embodiments, the portion of the instrument 22 can have a reduced outer diameter, or the instrument 22 can include a uniform diameter along all or a portion of the length of the instrument 22.
[0087] In some embodiments, given a 1 :2 advancement ratio between the guide feature 18 and the first end 25 of the instrument 22 (or another advancement ratio in which the second distance is greater than the first distance) and a 1 : 1 advancement ratio between the guide feature 18 and the first end 56 of the support tube 54, the first end 25 of the instrument 22 can exit the first end 56 of the support tube 54. In some embodiments, the first end 25 of the instrument 22 can exit the first end 56 of the support tube 54 to facilitate entry of the instrument 22 into a portion of the catheter assembly 30 that can be too narrow for the support tube 54 to enter.
[0088] In some embodiments, the delivery device 10 can facilitate timed or delayed exit of the instrument 22 from the support tube 54. More specifically, in some embodiments, the first end 25 of the instrument 22 can be shortened such that, when the guide feature 18 is fully retracted, the first end 25 of the instrument 22 is positioned flush with or proximal to the first end 56 of the support tube 54, e.g., as shown in Figure 3A
[0089] Reference is now made to Figures 4A-4B According to some embodiments, another delivery device 58 is shown. In some embodiments, the delivery device 58 can include or correspond to the delivery device 10 discussed with respect to FIGS. 1-3. More specifically, in some embodiments, the delivery device 58 can include one or more features of the delivery device 10, and / or the delivery device 10 can include one or more features of the delivery device 58.
[0090] In some embodiments, the second end 28 of the instrument 22 can be secured within an interface adapter 60, which can connect the delivery device 58 to a proximal end of a needleless connector or a proximal end of a catheter adapter (e.g., the catheter adapter 32 discussed with respect to FIGS. 1-3). In some embodiments, a needleless connector can be disposed between the interface adapter 60 and the catheter adapter and can connect the interface adapter 60 to the catheter adapter. In some embodiments, a proximal end 62 of the interface adapter 60 can be configured to couple with the distal connector 34 of the delivery device 58. In some embodiments, the proximal end 62 can include a luer adapter, such as a slip or threaded male or female luer adapter, or another suitable connector. In some embodiments, the proximal end 62 of the interface adapter 60 can be removably or non-removably coupled to the distal connector 34. In some embodiments, a distal end 63 of the interface adapter 60 can include a luer adapter, such as a slip or threaded male or female luer adapter, or another suitable connector, which can be configured to couple a proximal end of a needleless connector or a proximal end of a catheter adapter.
[0091] In some embodiments, the interface adapter 60 can include a side port 64, which can include a luer adapter, such as a slip or threaded male or female luer adapter, or another suitable connector. In some embodiments, the delivery device 58 can include a first cap and / or a second cap (not shown). In some embodiments in which the instrument 22 is entirely contained within the syringe 12 when the plunger 16 is in the proximal position, the first cap can be coupled to and seal the distal opening 46 of the syringe 12. In some embodiments in which the first end of the instrument 22 is secured within the interface adapter 60, the first cap can be coupled to and seal the distal end of the interface adapter 60. In some embodiments, the second cap can seal the side port 64. In some embodiments, for example, the first cap can be removable to allow the delivery device 58 to be connected to the interface adapter 60, and / or the second cap can be removable to allow a blood collection device to be coupled to the side port 64.
[0092] In some embodiments, a blood collection device, such as a needleless connector or a catheter adapter, can be coupled to the side port 64 of the interface adapter 60. In some embodiments, the blood collection device can include a luer adapter, such as a slip or threaded male or female luer adapter, or another suitable connector. In some embodiments, the blood collection device can be removably or non-removably coupled to the side port 64. Figures 1A-1BAnd 2A-2B, a blood collection device 23 can be coupled to the side port 64 to collect blood from the patient. In some embodiments, the blood collection device can include a syringe, a blood collection tube, or another suitable device. In some embodiments, an extension tube 24 can be coupled to the side port 64 and can extend from the side port 64. In some embodiments, a proximal end of the extension tube 24 can be coupled to the blood collection device.
[0093] In some embodiments, the side port 64 can include a lumen 66 that can be sealed from a lumen 68 of the interface adapter 60, which can prevent blood or other fluids from leaking into the lumen 68. In some embodiments, the lumen 66 can be sealed from the lumen 68 by way of a wall 70 through which the second end 28 of the instrument 22 and / or the second end 44 of the guidewire 40 (not shown in Figures 4A-4B In some embodiments, the guidewire 40 can be disposed within the instrument 22 and can operate in a manner similar to that discussed with respect to Figures 1A-1C and 2A-2B. Figures 1A-1C
[0094] Referring now to Figures 5A-5B In some embodiments, the delivery device 58 can include a support tube 54 that can extend from the guide feature 18. In some embodiments, the support tube 54 can be fixed to the guide feature 18. In some embodiments, in response to depression of the plunger 16, for example as shown in Figure 5B , the guide feature 18 can move a first distance in a distal direction, the instrument 22 can move through the support tube 54, and a first end 56 of the support tube 54 can be advanced a first distance in the distal direction. In some embodiments, the support tube 54 can include a uniform inner diameter and / or a uniform outer diameter along an entire length portion of the support tube 54.
[0095] Referring now to Figures 6A-6E , another example delivery device 72 is shown, in accordance with some embodiments. In some embodiments, the delivery device 72 can include or correspond to the delivery device 10 discussed with respect to FIGS. 1-3 and / or the delivery device 58 discussed with respect to FIGS. 4-5. More particularly, in some embodiments, the delivery device 72 can include one or more features of the delivery device 10 and / or the delivery device 58. In some embodiments, the delivery device 10 and / or the delivery device 58 can include one or more features of the delivery device 72.
[0096] In some embodiments, the instrument 22 can be coupled to the plunger 16 and can be moved along the plunger 16 in a distal direction to a deployed position. In some embodiments, the instrument 22 can also be moved proximally along the plunger 16 to retract the instrument 22. In these and other embodiments, the instrument 22 can be moved independently of the plunger. In some embodiments, the instrument 22 can extend distally into the barrel 14. In some embodiments, a distal end 74 of the instrument 22 can be configured to be advanced distally of a distal opening 46 of the syringe 12, for example as shown in Figures 6D-6E
[0097] In some embodiments, the plunger 16 can include at least one rib 76. In some embodiments, the instrument 22 can be coupled to and movable along the rib 76. In some embodiments, the instrument 22 can be coupled to the rib 76 via a deployment tab 81, which can extend over the rib 76, for example as shown in Figure 6C In some embodiments, the plunger 16 can include a stopper 78, which can include rubber or other suitable material. In some embodiments, the instrument 22 can be moved through the stopper 78 in response to the plunger 16 being moved to the deployed position.
[0098] As shown in Figure 6B In some embodiments, the positioning feature 80 can include a proximal end coupled to the deployment tab 81, which can be coupled to the instrument 22 and configured to move the instrument 22 proximally and / or distally. In some embodiments, the positioning feature 80 can be rigid. In some embodiments, a distal end 82 of the positioning feature 80 can contact an upper surface of the syringe 12 to prevent the deployment tab 81 and the instrument 22 from moving distally. In some embodiments, the distal end 82 of the positioning feature 80 can be free-floating and can contact the upper surface of the syringe 12 in response to movement of the deployment tab 81 and the instrument 22 in a distal direction. In some embodiments, the distal end 82 of the positioning feature 80 can be affixed or selectively affixed to the syringe 12. In some embodiments, the positioning feature 80 can fix the position of the instrument 22 when the delivery device 72 is packaged and / or prior to use.
[0099] In some embodiments, in response to depression of the plunger 16, the liquid 38 can flow out of the distal opening 46 of the syringe 12. In some embodiments, the distal end 26 of the syringe 12 can include a luer adapter, such as a sliding or threaded male or female luer adapter, or another suitable connector. In some embodiments, the syringe 12 can be coupled to a proximal end of the catheter adapter 32 of the catheter assembly 30 (e.g., as shown in Figures 1A-1B and 2A-2B), and the instrument 22 can be advanced in a distal direction such that the instrument 22 is disposed in a fluid path of the catheter assembly 30 and / or advanced beyond a distal end 48 of the catheter 36.
[0100] In some embodiments, the method of operating the delivery device 72 can include coupling the delivery device 72 to the proximal end of the catheter adapter 32, which can include the indwelling catheter 36. In some embodiments, the instrument 22 can then be advanced in the distal direction. In some embodiments, the plunger 16 can be depressed, causing the liquid 38 to flow around the instrument 22 and through the catheter 36 to flush the catheter 36 and the catheter assembly 30.
[0101] In some embodiments, the barrel 14 and / or the plunger 16 can include one or more indicia 19, which can provide a visual and / or tactile indication of instrument position to a user. More specifically, in some embodiments, the indicia 19 can indicate a distance of instrument 22 advancement and / or retraction. In some embodiments, the barrel 14 and / or the plunger 16 can be transparent. It will be appreciated that the barrel 14 and / or the plunger 16 of other embodiments can include indicia.
[0102] Referring now to Figures 7A-7C In some embodiments, the plunger 16 of the delivery device 72 can include a slot 84. In these and other embodiments, the instrument 22 can be disposed within the barrel 14 and coupled to an advancement tab 86 that is movable along the slot 84. In some embodiments, the advancement tab 86 can be coupled to the instrument 22 and configured to move the instrument 22 proximally and / or distally.
[0103] Referring now to Figures 8A-8E In accordance with some embodiments, another example delivery device 88 is shown. In some embodiments, the delivery device 88 can include or correspond to one or more of the following: the delivery device 10 discussed with respect to FIGS. 1-3; the delivery device 58 discussed with respect to FIGS. 4-5; and the delivery device 72 discussed with respect to FIGS. 6-7. More specifically, in some embodiments, the delivery device 88 can include one or more features of one or more of the following devices: the delivery device 10, the delivery device 58, and the delivery device 72. In some embodiments, one or more of the following devices can include one or more features of the delivery device 88: the delivery device 10, the delivery device 58, and the delivery device 72.
[0104] In some embodiments, the syringe 12 can include an outer barrel 90, an inner barrel 92, an elongate body 94 movable within the inner barrel 92, and a plunger head 96 disposed within the inner barrel 92. In some embodiments, the elongate body 94 can be advanced in the distal direction from a proximal position, such as that shown in Figure 8A and a distal end 98 of the elongate body 94 can be coupled to the plunger head 96, such as that shown in Figure 8Bshown. In some embodiments, in response to the elongated body 94 being advanced in the distal direction from the proximal position to couple to the plunger head 96, some of the liquid 38 can be expelled from the inner barrel 92. In some embodiments, in response to the coupling of the elongated body 94 and the plunger head 96, the elongated body 94 and the plunger head 96 can be configured to be advanced distally together to expel the liquid 38 from the inner barrel 92 through the distal opening 46 of the syringe 12, for example, as Figure 8C shown. In some embodiments, when the elongated body 94 and the plunger head 96 are coupled together, they can form a unitary plunger 16.
[0105] In some embodiments, the instrument 22 can extend from the distal end 98 of the elongated body 94 and through the plunger head 96. In some embodiments, in response to the elongated body 94 being advanced in the distal direction within the inner barrel 92, the distal end 74 of the instrument 22 can be advanced in the distal direction. In some embodiments, in response to the coupling of the elongated body 94 and the plunger head 96, the elongated body 94 and the plunger head 96 can be configured to be retracted proximally together to expel the liquid 38 from the inner barrel 92 into the outer barrel 90, for example, as Figure 8D shown. In some embodiments, the elongated body 94 can be coupled to the plunger head 96 in various ways, such as a snap fit, an interference fit, threads, a barb fit, etc. For example, Figures 8A-8D a barb fit is shown.
[0106] In some embodiments, one or more one-way valves 100 can be disposed between the inner barrel 92 and the outer barrel 90, and in response to the retraction of the elongated body 94 and the plunger head 96 coupled together, the liquid 38 can flow from the inner barrel 92 to the outer barrel 90 through the one-way valves. In some embodiments, the distal end of the inner barrel 92 and / or the distal end of the outer barrel 90 can include a septum 93. In some embodiments, the delivery device 88 can include a vent element to prevent a vacuum from being formed when the plunger is retracted proximally. In some embodiments, the vent element can provide venting to a portion of the inner barrel 92 distal of the plunger head 96, and can prevent a vacuum from being formed when the elongated body 94 and the plunger head 96 are retracted proximally.
[0107] In some embodiments, the proximal end of the outer barrel 90 can include a seal 97 proximate to an opening in the outer barrel 90 through which the elongated body 94 can extend. In some embodiments, the seal 97 can prevent fluid from leaking from the proximal end of the outer barrel 90.
[0108] In some embodiments, the outer barrel 90 can include multiple pieces that can be coupled together. More specifically, in some embodiments, the outer barrel 90 can include a first piece and a second piece that can be coupled together via welding, adhesive, pins, a press fit, or other suitable means. In some embodiments, the outer barrel 90 can be integrally formed as a single unit.
[0109] In some embodiments, the inner barrel 92 can be secured within the outer barrel 90 via one or more retention features. More specifically, in some embodiments, one or more retention features of the inner barrel 92 can mechanically mate (e.g., snap fit, press fit, or other suitable fit) with one or more retention features of the outer barrel 90. In some embodiments, the retention features can include ribs 99 extending from the inner barrel 92 to the outer barrel 90. An example rib 99 is shown in Figures 8A-8D some embodiments, the ribs 99 can be rigid or semi-rigid. In some embodiments, the retention features can be annular and can extend around a circumference of the inner barrel 92. In these and other embodiments, the retention features can include apertures and / or valves that can open in response to fluid pressure, allowing fluid to pass. In some embodiments, fluid can flow around the retention features.
[0110] As described above, in some embodiments, the elongated body 94 can be coupled to the plunger head 96 in various ways, such as a snap fit, interference fit, threads, barb fit, etc. Figure 8E Each of the elongated body 94 and the plunger head 96 are shown including one or more threads, in accordance with some embodiments. In some embodiments, the elongated body 94 is threaded to the plunger head 96. In some embodiments, after a user threads the elongated body 94 to the plunger head 96, the elongated body 94 and the plunger head 96 can be advanced together distally to expel the liquid 38 from the inner barrel 92 through the distal opening 46 of the syringe 12 and advance the instrument 22. In some embodiments, in response to the elongated body 94 being threaded to the plunger head 96, the elongated body 94 and the plunger head 96 can be configured to be retracted together proximally to expel the liquid 38 from the inner barrel 92 into the outer barrel 90 and retract the instrument 22. In some embodiments, in response to the elongated body 94 and the plunger head 96 being partially or fully retracted in the proximal direction, the user can unscrew the elongated body 94 from the plunger head 96, such that the elongated body 94 and the instrument 22 can be removed from the delivery device 88.
[0111] Reference is now made to Figures 9A-9CAccording to some embodiments, another delivery device 102 is shown. In some embodiments, the delivery device 102 can include or correspond to one or more of the following devices: the delivery device 10 discussed with respect to Figures 1-3; the delivery device 58 discussed with respect to Figures 4-5; the delivery device 72 discussed with respect to Figures 6-7; and the delivery device 88 discussed with respect to Figure 8. More specifically, in some embodiments, the delivery device 102 can include one or more features of one or more of the following devices: the delivery device 10, the delivery device 58, the delivery device 72, and the delivery device 88. In some embodiments, one or more of the following devices: the delivery device 10, the delivery device 58, the delivery device 72, and the delivery device 88 can include one or more features of the delivery device 102.
[0112] In some embodiments, the syringe 12 of the delivery device 102 can include an outer barrel 104, an inner barrel 106 containing the liquid 38 and movable within the outer barrel 104 between a proximal position and a distal position, a plunger 16 depressible within the inner barrel 106, and a first valve 108 disposed between the outer barrel 104 and the inner barrel 106. In some embodiments, the inner barrel 106 can be pre-filled with the liquid 38, for example, as shown in Figure 9A Figure 9A A delivery device 102 in an initial position or removed from packaging according to some embodiments is shown.
[0113] In some embodiments, the plunger 16 can include a second valve 110 configured to allow the liquid 38 to flow from the inner barrel 106 to the outer barrel 104 in a distal direction in response to depression of the plunger 16 within the inner barrel 106, for example, as shown in Figure 9B In some embodiments, the first valve 108 can close when the inner barrel 106 is in the distal position and during depression of the plunger 16, for example, as shown in Figure 9B In some embodiments, the first valve 108 can open in response to retraction of the plunger 16 in a proximal direction, and the liquid 38 can flow through a distal opening 46 of the syringe 12, for example, as shown in Figure 9C In some embodiments, the delivery device 102 can include a plurality of first valves 108 and / or a plurality of second valves 110, for example, as shown in Figure 9A
[0114] In some embodiments, the instrument 22 can extend through the plunger 16. In some embodiments, in response to depression of the plunger 16, the distal end 74 of the instrument 22 can be advanced in the distal direction. In some embodiments, the distal end 26 of the syringe 12 can include a distal connector 34, such as a sliding or threaded male or female luer adapter, or another suitable connector. In some embodiments, the distal end 74 of the instrument 22 can be blunt and / or tapered. In some embodiments, the distal connector 34 can be configured to couple to a proximal end of a catheter adapter. In some embodiments, the syringe 12 can be coupled to a proximal end of the catheter adapter 32 of the catheter assembly 30 (e.g., with the distal connector 34 of the syringe 12 coupled to the proximal end of the catheter adapter 32), and the plunger 16 can be depressed to advance the instrument 22 in the distal direction such that the instrument 22 is disposed in the fluid path of the catheter assembly 30 and / or advanced beyond the distal end 48 of the catheter 36. Figures 1A-1B and 2A-2B), and the plunger 16 can be depressed to advance the instrument 22 in the distal direction such that the instrument 22 is disposed in the fluid path of the catheter assembly 30 and / or advanced beyond the distal end 48 of the catheter 36.
[0115] In some embodiments, a method of operating the delivery device 102 can include coupling the delivery device 102 to a proximal end of the catheter adapter 32. In some embodiments, the plunger 16 can be depressed to advance the instrument 22 in the distal direction, which can also cause the liquid 38 to flow from the inner barrel 106 through the first valve 108 into the outer barrel 104. In some embodiments, depression of the plunger 16 can also cause the inner barrel 106 to move to the distal position, closing the second valve 110. In some embodiments, the plunger 16 can then be retracted or moved proximally, causing the instrument 22 to retract at least partially in the proximal direction. In some embodiments, proximal movement of the plunger 16 can also cause the inner barrel 106 to move proximally, thereby opening the second valve 110. In some embodiments, when the plunger is moved proximally, the liquid 38 disposed within the outer barrel 104 can exit the distal opening 46 of the syringe 12, and can flush the catheter assembly 30.
[0116] In some embodiments, an inner surface of the outer barrel 104 can include a stop or catch that can prevent the inner barrel 106 from moving proximally beyond the proximal position. In some embodiments, a proximal end of the outer barrel 104 can include a seal 97 proximate an opening in the outer barrel 104 through which the plunger 16 can extend. In some embodiments, the seal 97 can prevent leakage of fluid from the proximal end of the outer barrel 104.
[0117] In some embodiments, the inner barrel 106 can be secured within the outer barrel 104 via one or more retention features. More specifically, in some embodiments, one or more retention features of the inner barrel 106 can mechanically mate (e.g., snap fit, press fit, or other suitable mating) with one or more retention features of the outer barrel 104. In some embodiments, the retention features can include one or more ribs 99 (e.g., as shown in Figures 8A-8DA rib 99 can extend from the inner barrel 106 to the outer barrel 104 (as shown in FIG. 1). In some embodiments, the rib 99 can be rigid or semi-rigid. In some embodiments, the retention feature can be annular and can extend around the circumference of the inner barrel 106. In these and other embodiments, the retention feature can include holes and / or valves that can open in response to fluid pressure, allowing fluid to pass. In some embodiments, fluid can flow around the retention feature.
[0118] In some embodiments, the proximal end of the inner barrel 106 can include one or more retention features 111. In some embodiments, the proximal end of the inner barrel 106 can include a single annular retention feature 111. In some embodiments, the retention feature 111 can contact the plunger 16 to prevent proximal movement of the plunger 16. In some embodiments, the distal opening 46 can include an anti-backflow valve that can prevent blood from flowing back into the delivery device 102.
[0119] Referring now to Figures 10A-10B In accordance with some embodiments, another example delivery device 112 is shown. In some embodiments, the delivery device 112 can include or correspond to one or more of the following devices: the delivery device 10 discussed with respect to FIGS. 1-3; the delivery device 58 discussed with respect to FIGS. 4-5; the delivery device 72 discussed with respect to FIGS. 6-7; the delivery device 88 discussed with respect to FIG. 8; and the delivery device 102 discussed with respect to FIG. 9. More particularly, in some embodiments, the delivery device 112 can include one or more features of one or more of the following devices: the delivery device 10, the delivery device 58, the delivery device 72, the delivery device 88, and the delivery device 102. In some embodiments, one or more of the following devices: the delivery device 10, the delivery device 58, the delivery device 72, the delivery device 88, and the delivery device 102 can include one or more features of the delivery device 112.
[0120] In some embodiments, the plunger 16 can include a connector 114. In some embodiments, the connector 114 can include a luer adapter, such as a slip or threaded male or female luer adapter, or another suitable connector. In some embodiments, a channel 115 can extend from the connector 114 through the distal end of the plunger 16. In some embodiments, the connector 114 can be disposed within the plunger 16. In some embodiments, the connector 114 can be disposed distal to the proximal end 116 of the plunger 16.
[0121] In some embodiments, the instrument 22 can extend from the distal end 118 of the plunger 16. In some embodiments, the channel 115 can provide a fluid path for fluid infusion and / or blood withdrawal. In some embodiments, a blood collection device or fluid infusion device can be coupled to the connector 114. In some embodiments, a distal end of an extension tube can be coupled to the connector 114. In some embodiments, a proximal end of an extension tube 120 can be coupled to a blood collection device or infusion device. In some embodiments, the extension tube 120 can be in fluid communication with the channel 115 to provide a fluid path for fluid infusion and / or blood withdrawal.
[0122] In some embodiments, the distal end 26 of the syringe 12 can include a distal connector 34, such as a sliding or threaded male or female luer adapter, or another suitable connector. In some embodiments, the distal connector 34 can be configured to be coupled to a proximal end of a catheter adapter. In some embodiments, the syringe 12 can be coupled to a proximal end of the catheter adapter 32 of the catheter assembly 30 (e.g., at the distal connector 34), and the plunger 16 can be depressed to advance the instrument 22 in the distal direction such that the instrument 22 is disposed in the fluid path of the catheter assembly 30 and / or is advanced beyond the distal end 48 of the catheter 36. Figures 1A-1B and 2A-2B), and the plunger 16 can be depressed to advance the instrument 22 in the distal direction such that the instrument 22 is disposed in the fluid path of the catheter assembly 30 and / or is advanced beyond the distal end 48 of the catheter 36.
[0123] Referring now to Figure 10C In some embodiments, a distal end of the extension tube 120 can be integrated into the plunger 16. In some embodiments, a proximal end of the extension tube 120 can be coupled to a blood collection device or infusion device. In some embodiments, the extension tube 120 can be in fluid communication with the channel 115 to provide a fluid path for fluid infusion and / or blood withdrawal.
[0124] Referring now to Figure 11 According to some embodiments, an example method 100 is shown. In some embodiments, the method 100 can begin at block 102. In block 102, a delivery device can be coupled to a catheter adapter. The delivery device can include or correspond to the delivery device of one or more of the figures 1-10. In some embodiments, the delivery device can be coupled to the catheter adapter via a needleless connector and / or interface connector (e.g., the interface adapter 60 of Figures 4A-4B FIG. 6).
[0125] In some embodiments, block 102 can be followed by block 104. At block 104, the catheter adapter can be flushed with a liquid, such as saline or another suitable flushing liquid, while the instrument of the delivery device is advanced distally. In some embodiments, the instrument of the delivery device can be advanced distally into the vasculature of the patient. The instrument can include or correspond to the instrument 22 of one or more of FIGS. 1-10. In some embodiments, the catheter adapter can be flushed with a liquid, and the instrument can be advanced distally by depressing a plunger of the delivery device.
[0126] In some embodiments, block 104 can be followed by block 106. At block 106, a blood sample can be collected using the delivery device. In some embodiments, the blood sample can be collected in a blood collection device coupled to the delivery device.
[0127] In some embodiments, block 106 can be followed by block 108. At block 108, the instrument can be retracted proximally. In some embodiments, the distal end of the instrument can be disposed within the delivery device or the interface adapter when the instrument is retracted proximally.
[0128] In some embodiments, block 108 can be followed by block 110. At block 110, the delivery device can be decoupled from the catheter adapter. Although shown as discrete blocks, various blocks of the method 100 can be split into additional blocks, combined into fewer blocks, or eliminated, depending on the desired implementation. For example, in some embodiments, block 108 can be eliminated.
[0129] All examples and conditional language recited herein are intended to be construed to cover all permutations of features that are combinable under the principles of the present application and are not limited to the specific examples and conditions described. Although the present application has been described in some detail to provide a thorough understanding thereof, it will be apparent to one skilled in the art that various changes in form and details can be made without departing from the spirit and scope of the present application.
Claims
1. A delivery device for delivering instruments into a catheter assembly, comprising: A syringe includes an outer barrel, an inner barrel, an elongated body movable within the inner barrel, and a plunger head disposed within the inner barrel. The inner cylinder is fixed inside the outer cylinder via one or more retaining features; The syringe includes a distal opening and a distal connector at its distal end, the distal connector being configured to connect to the proximal end of a catheter adapter. In response to distal advancement of the elongated body within the inner barrel, the distal end of the elongated body is connected to the plunger head. In response to this connection, the elongated body and the plunger head are configured to advance distally together to expel liquid from the inner barrel through the opening. An instrument extending from the distal end of the elongated body and through the plunger head, wherein the distal end of the instrument is advanced in a distal direction in response to advancement of the elongated body within the inner cylinder.
2. The conveying device according to claim 1, wherein, The device includes a catheter or probe.
3. The conveying device according to claim 1, wherein, In response to the connection between the elongated body and the plunger head, the elongated body and the plunger head are also configured to retract together proximally to discharge liquid from the inner cylinder into the outer cylinder.
4. The conveying device according to claim 1, wherein, The retaining feature includes ribs extending from the inner cylinder to the outer cylinder, the ribs being rigid or semi-rigid.
5. The conveying device according to claim 1, wherein, The retaining feature is annular and extends around the circumference of the inner cylinder.
6. The conveying device according to any one of claims 1 to 5, wherein The retaining feature includes an orifice and / or a valve configured to open in response to fluid pressure to allow fluid to pass through; or The retaining feature is configured such that fluid can flow around the retaining feature.
7. The conveying device according to any one of claims 1 to 5, wherein, The conveying device includes one or more one-way valves disposed between the inner cylinder and the outer cylinder, wherein the one or more one-way valves are configured such that, in response to the retraction of the elongated body and the plunger head connected together, liquid can flow from the inner cylinder to the outer cylinder through the one or more one-way valves.
8. The conveying device according to any one of claims 1 to 5, wherein, The conveying device further includes a diaphragm disposed at the distal end of the inner cylinder and / or the distal end of the outer cylinder.
9. The conveying device according to any one of claims 1 to 5, wherein, The conveying device also includes a venting element configured to provide ventilation to the portion of the inner cylinder distal to the plunger head and to prevent a vacuum from forming when the elongated body and the plunger head retract proximally.
Citation Information
Patent Citations
Syringe Having a Collapsible Plunger Rod
US20110046569A1