Vascular access devices with fluid permeable structures and related devices

Abstract

A delivery device (12) for delivering a guidewire (48) through an intravenous catheter assembly includes a housing (50) having a distal end (52), a proximal end (54), and a slot (56). The delivery device includes a guidewire (48) having a proximal end (58) and a distal end (60). The delivery device includes a guidewire hub (62) disposed within the housing. The guidewire is secured to the guidewire hub, and the guidewire hub is configured to move along the slot to advance the guidewire distally. The distal end of the guidewire includes a fluid-permeable structure (64). For example, the fluid-permeable structure may include an elongated core (66) and a coil (68) extending around the elongated core, with the space between the elongated core and the coil configured to receive blood in response to insertion of the guidewire into the vasculature.

Description

TECHNICAL FIELD

[0001] Infusion therapy, which is a common medical practice, can be readily performed using a vascular access device. Hospitalized patients, patients receiving home care, and other patients receive fluids, medicaments, and blood products via a vascular access device inserted into the vascular system. Blood collection is another common medical procedure that can be facilitated by a vascular access device. BACKGROUND ART

[0002] Vascular access devices can access the peripheral or central blood vessels of a patient. Vascular access devices may be left in place for a short term (several days), a medium term (several weeks), or a long term (several months to several years). Vascular access devices can be used for continuous infusion therapy, or can be used for intermittent therapy.

[0003] A common vascular access device is an over-the-needle peripheral intravenous catheter (PIVC). As the name implies, an "over-the-needle" PIVC can be mounted over an introducer needle having a sharp distal tip. The sharp tip can be used to puncture the patient's skin and vascular system. Insertion of the PIVC into the vascular system can follow puncture of the vascular system by the needle. The needle and PIVC are generally inserted through the patient's skin into the blood vessel at a shallow angle, with the bevel of the needle facing away from the patient's skin. After confirming that the needle is placed within the blood vessel, the clinician can temporarily block the flow in the blood vessel, withdraw the needle, and leave the PIVC in place for future fluid infusion and blood collection.

[0004] Currently, there are several limitations to the use of PIVCs for fluid infusion or blood collection. PIVCs or veins can narrow, collapse, or become blocked over time, potentially leading to PIVC failure. Furthermore, blood extracted from PIVCs may often need to be discarded due to concerns about sample quality, resulting in unusable samples and the need for repeated blood collection. Additionally, collecting blood using PIVCs is time-consuming and somewhat inefficient, especially in patients with limited vein access or when the vein is not easily accessible to the clinician. The subject matter asserted herein is not limited to embodiments that resolve any shortcomings or embodiments that operate only in the environments described above. Rather, this background is provided merely to illustrate one exemplary technical field in which some of the implementations described herein may be put into practice. [Overview of the project]

[0005] This disclosure generally relates to vascular access systems, devices, and methods. More specifically, in some embodiments, this disclosure relates to systems, devices, and methods for positioning instruments through a catheter that may be implanted. In some embodiments, the instrument may include a guidewire. In some embodiments, the catheter may include a PIVC, a midline catheter, or a peripherally inserted central venous catheter (PICC).

[0006] In some embodiments, the instrument may extend beyond the distal end or tip of the catheter, thereby moving or displacing anything in the patient's vascular system that could occlude the catheter during blood collection. For example, the instrument may move or displace fibrin material, thrombi, or even venous walls. In some embodiments, the instrument may push open valves in the vascular system, allowing for backflow of blood into the catheter. In some embodiments, the instrument may open the distal tip of the catheter. In some embodiments, the instrument may reduce catheter twisting and the flow restriction caused by catheter twisting. In some embodiments, the instrument may extend beyond the distal tip of the catheter and the catheter insertion site, thereby facilitating bypass of local venous diameter limitations due to thrombi and / or venous structure. In some embodiments, the instrument may move the distal tip of the catheter away from the venous wall and toward the center of the vein, thereby reducing the chance of venous wall occlusion and / or damage due to shear stress from the flow.

[0007] In some embodiments, the device may include a fluid-permeable structure that can provide an elongated entry route or multiple entry routes to the distal tip of the catheter. In some embodiments, the fluid-permeable structure can prevent fibrin, thrombus, or other substances from occluding the distal tip of the catheter. In some embodiments, the device can increase the catheter's residence time. In some embodiments, the device may allow the catheter to be constructed from a softer and / or more flexible material, which may be gentler on blood vessels. In some embodiments, the device may allow blood to enter the catheter from a longer portion of the vein, which may reduce the blood collection filling time, especially for small gauge catheters.

[0008] In some embodiments, the guidewire may be delivered through the intravenous catheter assembly via any suitable delivery device. In some embodiments, the delivery device for delivering the guidewire through the intravenous catheter assembly may include a housing that may include a distal end, a proximal end, and a slot. In some embodiments, the delivery device may include a guidewire that may include a proximal end and a distal end. In some embodiments, the distal end of the guidewire may include a fluid-permeable structure.

[0009] In some embodiments, the delivery device may include a guidewire hub, which may be located within a housing. In some embodiments, the guidewire may be fixed to the guidewire hub. In some embodiments, the guidewire hub may be configured to move along a slot to advance the guidewire distally and to the distal end of the housing. In some embodiments, the guidewire may advance distally and / or retract proximal.

[0010] In some embodiments, the fluid-permeable structure may include an elongated core and a coil extending around the elongated core. In some embodiments, the coil may be coupled to the elongated core. In some embodiments, in response to the insertion of the guidewire into a blood vessel, blood may flow through the space between the elongated core and the coil. In some embodiments, the delivery device may include a gap between the outer diameter of the guidewire and the inner diameter of the catheter, which may allow blood to flow proximally from the vascular system through the gap.

[0011] In some embodiments, the guidewire may include a rounded distal tip, which may reduce the risk of damaging the vascular system when inserting the guidewire into the vascular system. In some embodiments, the rounded distal tip may reduce the risk of thrombosis or other complications. In some embodiments, the rounded distal tip may be formed by spot welding, adhesive, or other suitable means. In some embodiments, the rounded distal tip may be made of metal, plastic, elastomer, or other suitable material.

[0012] In some embodiments, the coil may be fixed to the elongated core at one or more positions along the length of the elongated core. For example, one or more bridges may extend from the coil to the elongated core to fix the coil to the elongated core. In some embodiments, the distal end of the coil may be coupled to the elongated core via a rounded distal tip. More specifically, in some embodiments, the distal end of the coil may be directly coupled to a rounded distal tip that can be directly coupled to the elongated core.

[0013] In some embodiments, the coil may be tightly wound around an elongated core at one or more locations to bond the coil to the elongated core. In some embodiments, the coil may include a distal end and a proximal end. In some embodiments, the distal end and / or proximal end of the coil may be tightly wound around the elongated core. In some embodiments, the elongated core may include a first portion which may include a first outer diameter and a second portion which may include a second outer diameter. In some embodiments, the second outer diameter may be larger than the first outer diameter. In some embodiments, the coil may be tightly wound around the second portion.

[0014] In some embodiments, the spacing between the rings of a coil may be generally uniform. In some embodiments, the spacing between the rings of a coil may vary. In some embodiments, the spacing between the rings may be narrower along one or more portions of the coil. For example, the rings may be in contact with each other or close to each other. In some embodiments, the spacing between the rings may be wider along other portions of the coil than along portions of the coil. In some embodiments, the distal end of the coil may be positioned distal to the distal end of the elongated core. In these and other embodiments, the distal end of the coil may be open or closed.

[0015] In some embodiments, the delivery device may include a tube that may have a proximal and distal end. In some embodiments, the guidewire may be delivered through the catheter assembly via any suitable delivery device. In some embodiments, the tube may be configured to extend into the catheter and / or into the patient's vascular system. In some embodiments, the guidewire may be located within the tube. In some embodiments, the distal end of the tube may include a fluid-permeable structure. In some embodiments, the guidewire and / or tube may reduce the number of needle sticks experienced by the patient due to the reduced frequency of catheter replacement. In some embodiments, the tube may allow the user to take blood samples or inject fluids through the catheter when the catheter becomes non-functional or less effective, for example, due to debris accumulation at the distal end of the catheter or the catheter disintegrating.

[0016] In some embodiments, the delivery device may include a tube hub located within a housing. In some embodiments, the tube may be fixed to the tube hub. In some embodiments, the tube hub may be configured to move along a slot to advance the tube distally toward the distal end of the housing. In some embodiments, the tube may advance distally and / or retract proximal a number of times.

[0017] In some embodiments, the catheter system may include a delivery device and a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter which may include a distal end, a proximal end, and a lumen extending between the distal and proximal ends. In some embodiments, the catheter may be fixed to the catheter adapter and may extend distally from the catheter adapter. In some embodiments, the catheter may include one or more diffusion holes which may provide an additional pathway for blood to enter the catheter.

[0018] In some embodiments, the catheter adapter may include a side port that can be angled relative to the distal end of the catheter adapter. In some embodiments, the catheter system may include an extension tube that may have a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be coupled to the side port. In some embodiments, the distal end of the extension tube may be integrated with the side port. In some embodiments, a fluid-permeable structure may facilitate the entry of blood into the catheter in response to the application of negative pressure to the side port of the catheter adapter.

[0019] In some embodiments, the connector may be coupled to the proximal end of the extension tube. In some embodiments, the proximal end of the extension tube may be integrated with the connector. In some embodiments, the connector may include a first port and a second port. In some embodiments, the connector may include two or more ports. In some embodiments, a delivery device may be coupled to the first port of the connector. In some embodiments, another extension tube may be coupled to the second port of the connector. In some embodiments, a blood collection device may be coupled to the proximal end of another extension tube.

[0020] In some embodiments, blood may be prevented from entering the delivery device. For example, the distal end of the housing may include a partition to prevent fluid from flowing into the distal end of the housing. In some embodiments, the fluid pathway of the catheter system may include one or more of the catheter, catheter adapter, extension tube, and other extension tubes. In some embodiments, blood may be collected via a fluid pathway that cannot extend through the housing of the delivery device. In some embodiments, the fluid pathway may not include or be located within a large portion or all of the housing. In some embodiments, blood may not flow within or through the housing of the delivery device. In some embodiments, the delivery device may not be a blood collection device, and instead, the delivery device may facilitate the flow of blood through a catheter and enable blood collection through a fluid pathway, which may include a catheter assembly and / or may not include the housing of the delivery device.

[0021] In some embodiments, a delivery device may be coupled to the proximal end of the catheter adapter. In these embodiments, the fluid pathway of the catheter system may include a catheter, a catheter adapter, and an extension tube. In some embodiments, a blood collection device may be coupled to the proximal end of the extension tube.

[0022] In some embodiments, the catheter system instrument may include an extension device which may include an elongated body. In some embodiments, the extension device may be obturator-like, except that the extension device may not obstruct the fluid pathway through the catheter, and instead may facilitate the flow of fluid through the catheter. In some embodiments, the elongated body may include a fluid permeable structure which may be configured to allow fluid to enter the distal end of the catheter in response to the extension device being inserted through the catheter. In some embodiments, the fluid permeable structure of the extension device may include one or more grooves, one or more flat areas, one or more side holes, or one or more axially running channels. In some embodiments, the extension device may include a rod which includes one or more grooves, one or more flat areas, one or more side holes, or one or more axially running channels.

[0023] It should be understood that both the general description above and the detailed description below are illustrative and descriptive, and do not limit the invention as described in the claims. It should be understood that various embodiments are not limited to the arrangements and fixtures shown in the drawings. Furthermore, it should be understood that embodiments can be combined, other embodiments utilized, and structural modifications not described in the claims can be made without departing from the scope of the various embodiments of the invention. Therefore, the detailed description below should not be taken as restrictive. [Brief explanation of the drawing]

[0024] Exemplary embodiments will be described in more specific and detail with reference to the following attached drawings.

[0025] [Figure 1A] Figure 1A is a top perspective view of an exemplary catheter system according to several embodiments. [Figure 1B]FIG. 1B is a top perspective view of an exemplary delivery device of the catheter system of FIG. 1A, illustrating an exemplary guidewire in a retracted position, according to some embodiments. [Figure 1C] FIG. 1C is a top perspective view of the delivery device of the catheter system of FIG. 1A, illustrating the guidewire in an advanced position, according to some embodiments. [Figure 1D] FIG. 1D is a cross-sectional view of the delivery device of the catheter system of FIG. 1A, illustrating the guidewire in a retracted position, according to some embodiments. [Figure 1E] FIG. 1E is a cross-sectional view of the delivery device of the catheter system of FIG. 1A, illustrating the guidewire in an advanced position, according to some embodiments. [Figure 1F] FIG. 1F is an enlarged top perspective view of a portion of the catheter system of FIG. 1A, illustrating the guidewire in an advanced position, according to some embodiments. [Figure 1G] FIG. 1G is a top perspective view of an exemplary distal end of the catheter system of FIG. 1A, illustrating the guidewire in an advanced position, according to some embodiments. [Figure 1H] FIG. 1H is a cross-sectional view of an exemplary distal end of the catheter system of FIG. 1A, illustrating the guidewire in an advanced position positioned within the vasculature of a patient, according to some embodiments. [Figure 2A] FIG. 2A is a top perspective view of an exemplary distal end of the guidewire of the catheter system of FIG. 1A, according to some embodiments. [Figure 2B] FIG. 2B is a top perspective view of another exemplary distal end of the guidewire of the catheter system of FIG. 1A, according to some embodiments. [Figure 2C] FIG. 2C is a top perspective view of another exemplary distal end of the guidewire of the catheter system of FIG. 1A, according to some embodiments. [Figure 2D] FIG. 2D is a top perspective view of another exemplary distal end of the guidewire of the catheter system of FIG. 1A, according to some embodiments. [Figure 2E]Figure 2E is a top perspective view of another exemplary distal end of the guidewire of the catheter system of Figure 1A, according to several embodiments. [Figure 2F] Figure 2F is a top perspective view of another exemplary distal end of the guidewire of the catheter system of Figure 1A, according to several embodiments. [Figure 2G] Figure 2G is a top perspective view of another exemplary distal end of the guidewire of the catheter system of Figure 1A, according to several embodiments. [Figure 3A] Figure 3A is a top perspective view of another exemplary distal end of the catheter system of Figure 1A, illustrating the guidewire and exemplary diffusion hole in the advanced position according to several embodiments. [Figure 3B] Figure 3B is a top perspective view of the distal end of another exemplary catheter system of Figure 1A, illustrating the guidewire and diffusion hole in the advanced position according to several embodiments. [Figure 4A] Figure 4A is a top perspective view of another exemplary catheter assembly of the catheter system of Figure 1A, according to several embodiments. [Figure 4B] Figure 4B is a top perspective view of a delivery device of the catheter system shown in Figure 1A, according to several embodiments. [Figure 5A] Figure 5A is a top perspective view of the catheter system of Figure 1A, illustrating exemplary syringes according to several embodiments. [Figure 5B] Figure 5B is a top perspective view of the catheter system in Figure 1A, illustrating a syringe replaced with a blood collection tube in several embodiments. [Figure 6A] Figure 6A is a top perspective view of another delivery device that may be used with the catheter system of Figure 1A, according to several embodiments. [Figure 6B] Figure 6B is a cross-sectional view of another delivery device shown in Figure 6A, according to several embodiments. [Figure 6C]Figure 6C is a cross-sectional view of another delivery device in Figure 6A coupled to another exemplary catheter assembly, illustrating a partially advanced guidewire according to several embodiments. [Figure 7A] Figure 7A is a top perspective view of another delivery device coupled with the catheter system of Figure 1A, according to several embodiments. [Figure 7B] Figure 7B is a cross-sectional view of the delivery device of Figure 7A, illustrating a guide wire and exemplary tube in the forward position according to several embodiments. [Figure 7C] Figure 7C is a top perspective view of the delivery device of Figure 7A coupled to the catheter system of Figure 1A, according to several embodiments. [Figure 7D] Figure 7D is a cross-sectional view of the delivery device of Figure 7A coupled to the catheter system of Figure 1A, according to several embodiments. [Figure 7E] Figure 7E is a top perspective view of the distal end of another exemplary catheter system of Figure 1A, according to several embodiments. [Figure 7F] Figure 7F is an enlarged top perspective view of the other distal end of Figure 7E, according to several embodiments. [Figure 7G] Figure 7G is a top perspective view of the distal end of another exemplary catheter system of Figure 1A, according to several embodiments. [Figure 7H] Figure 7H is an enlarged top perspective view of the other distal end of Figure 7G, according to several embodiments. [Figure 8A] Figure 8A is a top perspective view of the exemplary distal end of an exemplary extension device according to several embodiments. [Figure 8B] Figure 8B is a cross-sectional view of the distal end along line 8B–8B in Figure 8A, according to several embodiments. [Figure 8C] Figure 8C is a top perspective view of another exemplary distal end of the extension device shown in Figure 8A, according to several embodiments. [Figure 8D] Figure 8D is a cross-sectional view of the other distal end along line 8D-8D in Figure 8C, according to several embodiments. [Figure 8E] Figure 8E is a top perspective view of another exemplary distal end of the extension device of Figure 8A, according to several embodiments. [Figure 8F] Figure 8F is a cross-sectional view of the other distal end along the line 8F-8F in Figure 8E, according to several embodiments. [Figure 8G] Figure 8G is a top perspective view of another exemplary distal end of the extension device of Figure 8A, according to several embodiments. [Figure 8H] Figure 8H is a top perspective view of another exemplary distal end of the extension device shown in Figure 8A, according to several embodiments. [Figure 8I] Figure 8I is a cross-sectional view of the other distal end along line 8I-8I in Figure 8H, according to several embodiments. [Figure 8J] Figure 8J is a cross-sectional view of an exemplary catheter assembly illustrating another exemplary extension device according to several embodiments. [Figure 9A] Figure 9A is a top perspective view of another delivery device illustrating a guide wire in a retracted position according to several embodiments. [Figure 9B] Figure 9B is a top perspective view of the delivery device of Figure 9A, illustrating the guide wire in the forward position according to several embodiments. [Figure 10A] Figure 10A is a top perspective view of another delivery device illustrating a guide wire and exemplary tube in a retracted position according to several embodiments. [Figure 10B] Figure 10B is an upper perspective view of the delivery device of Figure 10A, illustrating a guide wire and exemplary tube in the forward position according to several embodiments. [Figure 10C] Figure 10C is a cross-sectional view illustrating an exemplary hub of the delivery device shown in Figure 10A, according to several embodiments. [Modes for carrying out the invention]

[0026] In this disclosure, the term “distal” refers to the part of the catheter system or its components that is farther from the user, and the term “proximal” refers to the part of the catheter system or its components that is closer to the user. As used in this disclosure, the term “user” may refer to a clinician, physician, nurse, or other care provider, and may include support personnel.

[0027] Referring here to Figures 1A–1E, in some embodiments, the catheter system 10 may include a delivery device 12 and a catheter assembly 14. In some embodiments, the delivery device 12 may include any suitable housing. In some embodiments, the housing may include a foldable tube or flexible tube or any other suitable element that generally surrounds the instrument to facilitate a sterile environment. For example, the delivery device 12 may include a linear or rotating mechanism or any other suitable mechanism. In some embodiments, the delivery device 12 is described, for example, in U.S. Patent Application No. 62 / 660,661 filed April 20, 2018, entitled “Instrument Delivery Device Having a Rotating Body,” U.S. Patent Application No. 62 / 773,029 filed November 29, 2018, entitled “Syringe-Type Delivery Device for Vascular Access Instruments,” and U.S. Patent Application No. 62 / 696,229 filed July 10, 2018, entitled “Delivery Device for Vascular Access Instruments,” each of which is incorporated in whole by reference.

[0028] In some embodiments, the catheter assembly 14 may include a catheter adapter 16, which may include a distal end 18, a proximal end 20, and a lumen 22 extending between the distal end 18 and the proximal end 20. In some embodiments, the catheter 24 may be fixed to the catheter adapter 16 and may extend distally from the catheter adapter 16. In some embodiments, the catheter 24 may include a PIVC, a midline catheter, or a peripherally inserted central venous catheter (PICC).

[0029] In some embodiments, the delivery device 12 may be coupled to any suitable catheter assembly. In these and other embodiments, the catheter assembly 14 may include a linear or non-integrated catheter assembly. In some embodiments, the catheter assembly 14 may include an integrated catheter assembly. More specifically, in some embodiments, the catheter adapter 16 of the catheter assembly 14 may include an integrated extension tube, such as the BD NEXIVA® Closed IV Catheter System, the BD NEXIVA® DIFFUSICS® Closed IV Catheter System, or the Becton Dickinson PEGASUS® Safety Closed IV Catheter System.

[0030] As shown in Figure 1A, in some embodiments, the catheter adapter 16 may include a side port 26, which may be angled relative to the distal end 18 of the catheter adapter 16. In some embodiments, the catheter assembly 14 may include an extension tube 28 which may include a distal end 30 and a proximal end 32. In some embodiments, the extension tube 28 may be short to provide closer access to the patient. However, in some embodiments, the length of the extension tube 28 may vary. In some embodiments, the distal end 30 of the extension tube 28 may be coupled to the side port 26. In some embodiments, the distal end of the extension tube 28 may be integrated with the side port 26.

[0031] In some embodiments, the connector 34 may be coupled to the proximal end 32 of the extension tube 28. In some embodiments, the proximal end 32 of the extension tube 28 may be integrated with the connector 34. In some embodiments, the connector 34 may include a Y-adapter, a T-port, or other suitable connector. In some embodiments, the connector 34 may include a male or female Luer connector having Luer slip or Luer lock functionality. In some embodiments, the connector 34 may include two or more ports.

[0032] In some embodiments, the connector 34 may include a first port 36 and a second port 38. In some embodiments, the delivery device 12 may be coupled to the first port 36 of the connector 34. In some embodiments, another extension tube 40 may be coupled to the second port 38 of the connector 34. In some embodiments, the catheter assembly 14 may include a needleless connector 39, and the delivery device 12 may be coupled to the first port 36 of the connector 34 via the needleless connector 39 which may be positioned between the delivery device 12 and the connector 34. In some embodiments, the connector 34 and the needleless connector 39 may be formed integrally. In some embodiments, the needleless connector 39 may include any suitable needleless connector.

[0033] In some embodiments, the proximal end 42 of the other extension tube 40 may include a connector 44, which can be coupled to any suitable blood collection device such as a syringe, vacuum tube, blood collection tube, or holder. In some embodiments, the blood collection device may include or correspond to a fluid reservoir. In some embodiments, the connector 44 may include a male or female Luer connector having Luer slip or Luer lock functionality. In some embodiments, the connector 44 may be coupled to a holder 46 which can be configured to accept another blood collection device. In some embodiments, the holder 46 may include a cannula configured to puncture the seal of a particular blood collection device. In some embodiments, the connector 44 may be coupled to a needleless connector 39, which can be coupled to the holder 46 or another blood collection device.

[0034] In some embodiments, the instrument, which may include a guidewire 48, can be delivered through the catheter assembly 14 via any suitable delivery device. In some embodiments, the delivery device 12 may include a housing 50, which may include a distal end 52, a proximal end 54, and a slot 56 that may extend between the distal end 52 and the proximal end 54. In some embodiments, the delivery device 12 may include a guidewire 48 which may include a proximal end 58 and a distal end 60.

[0035] In some embodiments, the delivery device 12 may include a guidewire hub 62 which may be located within the housing 50. In some embodiments, a guidewire 48 may be fixed to the guidewire hub 62. In some embodiments, the guidewire hub 62 may be configured to move along a slot 56 to advance the guidewire 48 distally and distal to the distal end 52 of the housing 50. In some embodiments, the guidewire 48 may be advanced distally and / or retracted proximal. In some embodiments, the guidewire hub 62 and one or more other components of the delivery device 12 may be further described in U.S. Patent Application No. 62 / 660,646, filed April 20, 2018, entitled “Multi-diameter Catheters and Related Devices and Methods,” which is incorporated herein by reference in its entirety.

[0036] In some embodiments, blood may flow proximal to the catheter adapter 16, extension tube 28, and other extension tubes 40 from the catheter 24. In some embodiments, blood may be prevented from entering the delivery device 12. For example, the distal end 52 of the housing 50 may include a partition 65 to prevent fluids such as blood from flowing into the distal end 52 of the housing 50. In other embodiments, blood may be allowed to flow proximal through the housing 50, and the housing 50 may include a tube coupled to the blood collection device. In some embodiments, the distal end 52 of the housing 50 may be coupled to a connector, which may include a male or female Luer connector with Luer slip or Luer lock functionality, or another suitable connector. In some embodiments, the partition 65 may be located within the connector coupled to the distal end 52 of the housing 50, for example, as shown in Figure 1D.

[0037] Referring here to Figure 1F-1H, in some embodiments, the distal end 60 of the guidewire 48 may include a fluid permeable structure 64. In some embodiments, the fluid permeable structure 64 may include an elongated core 66 and a coil 68 extending around the elongated core 66. In some embodiments, as the guidewire 48 is inserted into the patient's vascular system, blood may flow into the space between the elongated core 66 and the coil 68.

[0038] In some embodiments, the guidewire 48 may be advanced beyond the distal tip 70 of the catheter 24, which may move or push anything in the patient's vascular system that could occlude the catheter 24 during blood collection. For example, the guidewire 48 may move over, push aside, or move over fibrin material or a thrombus, or move the distal tip 70 of the catheter 24 away from a vein wall or valve. As shown in Figure 1H, in some embodiments, the guidewire 48 may push open a valve in the vascular system, allowing backflow of blood into the catheter 24. In some embodiments, the guidewire 48 may remain inside the catheter 24 and extend beyond the distal tip 70 of the catheter during blood collection and / or fluid infusion.

[0039] In some embodiments, the fluid-permeable structure 64 may include an elongated inlet path or multiple inlet paths to the distal tip 70 of the catheter 24. In some embodiments, the fluid-permeable structure 64 may prevent fibrin, thrombus, or other material from occluding the distal tip 70 of the catheter 24. In some embodiments, the delivery device 12 may include a gap between the outer diameter of the guidewire 48 and the catheter 24, which may allow blood to flow proximally from the vascular system through the gap. In some embodiments, the delivery device 12 may include a gap between the outer diameter of the guidewire 48 and the distal tip 70 of the catheter 24, which may allow blood to flow proximally from the vascular system through the gap.

[0040] In some embodiments, the catheter 24 and / or catheter adapter 16 may be composed of FEP, TEFLON, silicone, TPE, TPU, fluoropolymer, or other suitable material. In some embodiments, the catheter 24 may be hydrophilic or hydrophobic. In some embodiments, the distal tip of the catheter 70 may be asymmetrical. In some embodiments, the catheter 24 may include an antithrombotic coating and / or antifouling material.

[0041] Referring here to Figure 2A-2G, in some embodiments, the coil 68 may include metal wires arranged spirally around an elongated core 66. In some embodiments, the elongated core 66 may be made of a solid and / or metal or other suitable material. In some embodiments, the elongated core 66 may be thin to provide some flexibility. In some embodiments, the elongated core 66 may be made of nitinol. In some embodiments, the coil 68 may be coupled to the elongated core 66.

[0042] In some embodiments, the guidewire 48 may include a rounded distal tip 72, which may reduce the risk of damaging the vascular system when the potentially flexible guidewire 48 is inserted into the vascular system. In some embodiments, the rounded distal tip 72 may reduce the risk of thrombosis or other complications. In some embodiments, the rounded distal tip 72 may be spot-welded or formed via other suitable means and / or material.

[0043] In some embodiments, the coil 68 may include a distal end 74 and a proximal end 76. In some embodiments, the distal end 74 of the coil 68 may be coupled to an elongated core 66 via a rounded distal tip 72. More specifically, in some embodiments, the distal end of the coil 68 may be directly coupled to a rounded distal tip 72, which may be directly coupled to the elongated core 66.

[0044] In some embodiments, the coil 68 may be tightly wound around the elongated core 66 at one or more positions to bond the coil 68 to the elongated core 66. In some embodiments, the distal end 74 of the coil 68 may be tightly wound around the elongated core 66. In some embodiments, the proximal end 76 of the coil 68 may be tightly wound around the elongated core 66, as shown, for example, in Figure 2A.

[0045] In some embodiments, the elongated core 66 may include a first portion 78 which may include a first outer diameter and a second portion 80 which may include a second outer diameter. In some embodiments, the second outer diameter may be larger than the first outer diameter. In some embodiments, the coil 68 may be tightly wound around the second portion 80, for example, as shown in Figure 2F. In some embodiments, the elongated core 66 may be tapered or stepped between the first portion 78 and the second portion 80. In some embodiments, the guidewire 48 may include multiple diameters along its length, for example, depending on the corresponding inner diameter of the catheter assembly 14. In some embodiments, the elongated core 66 may have a uniform outer diameter along its entire length, for example, as shown in Figure 2G.

[0046] In some embodiments, the spacing between the rings 82 of the coil 68 may be generally uniform, as shown, for example, in Figures 2A-2B. In some embodiments, the spacing between the rings 82 of the coil 68 may vary. For example, as shown in Figure 2D, in some embodiments, the spacing between the rings 82 may be close or dense along one or more portions of the coil (e.g., the rings 82 may be in contact with or close to each other), while along other portions of the coil 68, the spacing between the rings may be wider than along portions of the coil 68.

[0047] For example, as shown in Figure 2E, in some embodiments, the distal end 74 of the coil 68 may be positioned distal to the distal end 84 of the elongated core 66. In these and other embodiments, the distal end 74 of the coil 68 may be open or closed. In some embodiments, the distal end 74 of the coil 68 may be closed, for example, by a rounded distal tip 72. In some embodiments, the distal end 74 of the coil 68 may be closed by spot welding, adhesive, overmolding, bonding with a plastic or elastomer tip, or by another suitable method. In some embodiments, the distal end 84 of the elongated core 66 may be blunt or rounded.

[0048] For example, as shown in Figure 2F, in some embodiments, the coil 68 may be fixed to the elongated core 66 at one or more positions along the length of the elongated core 66. For example, one or more bridges 86 may extend from the coil 68 to the elongated core 66, fixing the coil 68 to the elongated core 66 at one or more points along the length of the coil 68. In these and other embodiments, the elongated core 66 may extend along the central axis of the coil 68. In some embodiments, the delivery device 12 may include any suitable elongated core and / or any suitable coil. In some embodiments, the bridges 86 may be formed by welding, adhesive, or other suitable means.

[0049] In some embodiments, the elongated core 66 may not extend along the central axis of the coil 68. In these embodiments, the elongated core 66 may be offset from the central axis of the coil 68. In these and other embodiments, the elongated core 66 may contact the coil 68 at multiple contact points along the length of the coil 68 and / or be coupled to the coil 68 at one or more contact points. In some embodiments, the elongated core 66 may be coupled to the coil 68 by welding, adhesive, or other suitable means.

[0050] Referring here to Figures 3A-3B, in some embodiments, the catheter 24 may include one or more diffusion holes 88, which may provide an additional pathway for blood to enter the catheter 24. In some embodiments, the coil 68 may extend into the catheter 24. In some embodiments, the coil 68 may extend through all or part of the catheter 24. In some embodiments, the coil 68 may extend proximal beyond the diffusion holes 88. In some embodiments, the coil 68 may not extend proximal beyond the diffusion holes 88.

[0051] In some embodiments, the second portion 80 may be positioned proximal to the distal opening 90 of the catheter 24. In some embodiments, the delivery device 12 may include a gap 93 between the outer diameter of the guidewire 48 and the distal opening 90 of the catheter 24, which may allow blood to flow proximal from the vascular system through the gap 93. In some embodiments, the elongated core 66 may be sized according to a specific catheter gauge size with which it may be used.

[0052] In some embodiments, the outer diameter of the coil 68 and / or the elongated core 66 may be variable, tapered, or straight. In some embodiments, the outer diameter of the coil 68 may be larger than the diameter of the distal opening 90 of the catheter 24, and the coil 68 may be compressible.

[0053] Referring here to Figure 4A, in some embodiments, the delivery device 12 may be coupled to the proximal port of a T-connector 91, which may include a needleless connector. In some embodiments, the distal port of the T-connector 91 may be coupled to the proximal end 20 of a catheter adapter 16. In these and other embodiments, the catheter adapter 16 may not include a side port 26 and / or an integrated extension tube. In some embodiments, an extension tube 28 may be coupled to a side port of the T-connector, which may be angled relative to the proximal and distal ports.

[0054] In some embodiments, the fluid pathway of the catheter system 10 may include a catheter 24, a catheter adapter 16, a T-connector, and an extension tube 28. In some embodiments, the proximal end 32 of the extension tube 28 may be connected to a connector 92 which can be connected to any suitable blood collection device. In some embodiments, the connector 92 may include a male or female Luer connector having Luer slip or Luer lock functionality. In some embodiments, the connector 92 may be connected to a needleless connector 39 which can be connected to a holder 46 or other blood collection device.

[0055] In some embodiments, the connector 92 may be coupled to a holder 46 configured to receive a specific blood collection device, such as a blood collection tube, vacuum tube, or syringe. In some embodiments, the holder 46 may include a cannula configured to puncture the seal of the specific blood collection device.

[0056] Referring here to Figure 4B, in some embodiments, the extension tube 40 may extend from the delivery device 12. For example, a connector coupled to the distal end 52 of the housing 50 may include a port, or the housing 50 which may include a port. In some embodiments, the extension tube 40 may be coupled to a port and / or integrated with a port. In some embodiments, the delivery device 12 may include a partition at the distal end of the housing 20 or within the connector. In some embodiments, the partition may be proximal to the port, which may prevent blood from moving proximal to the partition and passing through most of the housing 50.

[0057] Referring to Figure 5A, a holder 46 is shown coupled to an exemplary flush syringe 94 which may be pre-filled with saline solution. Referring to Figure 5B, a holder 46 is shown coupled to an exemplary blood collection tube 96. In some embodiments, the flush syringe 94 is used to flush the catheter 24 to ensure patency and to draw in an initial waste sample into the flush syringe 94. After this, the flush syringe 94 may be detached from the connector 34 (or the connector 92 as described in Figure 4), and the blood collection tube 96 or another suitable blood collection device may be coupled to the connector 92.

[0058] Referring here to Figures 6A-6C, several embodiments of the delivery device 100 are illustrated. In some embodiments, the delivery device 100 may be similar to or identical to the delivery device 12 disclosed in Figures 1-5 of this disclosure in terms of one or more included components and / or operation. In some embodiments, the delivery device 100 may include a tube 102 which may include a proximal end 104 and a distal end 106.

[0059] In some embodiments, the tube 102 may be configured to extend into and / or through the catheter 24 into the patient's vascular system. In some embodiments, the guidewire 48 may be positioned inside the tube 102 and / or extend distally through the tube 102 when the guidewire 48 is advanced. In some embodiments, the guidewire 48 may be fully retracted when the tube 102 is advanced, as shown, for example, in Figures 6A-6B. In some embodiments, the guidewire 48 and the tube 102 may advance and / or retract simultaneously.

[0060] In some embodiments, the guidewire and / or tube 102 may reduce the number of needle sticks experienced by the patient, as catheter replacement may be less frequent. In some embodiments, the tube 102 may allow the user to take blood samples or inject fluids through the catheter 24 when the catheter 24 becomes non-functional or less effective, for example, due to debris accumulation at the distal end of the catheter 24 or the catheter 24 disintegrating.

[0061] In some embodiments, the delivery device 100 may include a tube hub 107 located within a housing 50. In some embodiments, a tube 102 may be fixed to the tube hub 107. In some embodiments, the tube hub 107 may be configured to move along a slot 56 to advance the tube 102 distally to the distal end 52 of the housing 50. In some embodiments, the tube 102 may advance distally and / or retract proximal. In some embodiments, the tube 102, the guidewire hub 62, the tube hub 107, and one or more other components of the delivery device 100 may be further 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 herein by reference in its entirety.

[0062] Referring here to Figures 7A-7D, delivery devices 108 in several embodiments are illustrated. In some embodiments, the delivery device 108 may be similar to or identical to the delivery device 12 disclosed in Figures 1-5 and / or the delivery device 100 disclosed in Figure 6 of this disclosure in terms of one or more included components and / or operation.

[0063] In some embodiments, the delivery device 108 may include a tube 110 which may have a proximal end 112 and a distal end 114. In some embodiments, the proximal end 112 of the tube 110 may be coupled to a connector 116 which may include a male or female Luer connector having Luer slip or Luer lock functionality. In some embodiments, the connector 116 may be coupled to any suitable blood collection device. In some embodiments, the connector 116 may be coupled to a holder 46 which may be configured to accept another blood collection device. In some embodiments, the proximal end 58 of a guidewire 48 and / or the distal end 114 of the tube 110 may be fixed within a hub 115.

[0064] In some embodiments, the proximal end of the tube 102 may be fixed within the hub 115. In some embodiments, the guide wire 48 may be longer than the tube 102 and extend distally beyond the distal end 52 of the housing 50.

[0065] In some embodiments, the hub 115 may include an advance tab 119 within the slot 56. In some embodiments, the hub 115 can be moved distally within the slot 56 to advance the guidewire 48 and tube 102 distally simultaneously. Figures 7B-7D illustrate the state in which the guidewire 48 and tube 102 have been fully advanced distally according to some embodiments. In some embodiments, the hub 115 can be moved proximal to retract the guidewire 48 and tube 102. In some embodiments, corresponding to the tube 102 being fully advanced distally, the distal end 106 of the tube 102 may be positioned or terminated proximal to the distal end 70 of the catheter 24, which may allow the tube 102 to include a larger outer diameter and / or improve the visualization of the distal end 114 in the fully advanced position.

[0066] In some embodiments, in response to the tube 102 being fully advanced distally, the distal end 106 of the tube 102 may be positioned or terminated distal to the distal tip 70 of the catheter 24, or proximal to the distal tip 70, proximal to the catheter wedge, or proximal to the catheter wedge within the catheter adapter 16. In some embodiments, the outer diameter of the distal end 106 may provide a seal wherever it is terminated, which may reduce mixing of the fluid in the catheter assembly 14 with the collected blood and reduce waste. In some embodiments, in response to the tube 102 being fully advanced distally, the distal end 106 of the tube 102 may be positioned anywhere in the fluid path. In some embodiments, the coil 68 may be positioned inside the tube 102.

[0067] Referring here to Figures 7E-7H, in some embodiments, the guidewire 48 may include a tube 118 in addition to, or instead of, the coil 68. In some embodiments, the tube 118 may include a fluid-permeable structure 64. For example, in some embodiments, the tube 118 may be porous. As shown in Figure 7E, in some embodiments, the tube 118 may include a plurality of holes 120, which may be arranged in various patterns and numbers and may include various sizes. In some embodiments, the holes 120 may be located at the distal end 122 of the tube 118. In some embodiments, the holes 120 may be arranged in a staggered pattern.

[0068] In some embodiments, the distal end 122 of the tube 118 may be open or closed. In some embodiments, the distal end 122 of the tube 118 may be coupled to a rounded distal tip 72. In some embodiments, the proximal end 123 of the tube 118 may be located within the catheter 24 and / or be tapered. In some embodiments, the proximal end 123 of the tube 118 may include one or more holes 125, which may be larger and / or smaller than the hole 120. In some embodiments, the proximal end 123 of the tube 118 may be coupled to an elongated core 66.

[0069] As shown in Figure 7G, in some embodiments, the tube 118 may include a plurality of slits 124, which may be arranged in various patterns and numbers and may include various sizes. In some embodiments, the slits 124 may be located at the distal end 122 of the tube 118. In some embodiments, the slits 124 may be arranged in a staggered pattern. In some embodiments, the slits 124 may be cut perpendicular to the longitudinal axis of the catheter 24, although in some embodiments, the angle of the slits 124 may vary. In some embodiments, an elongated core 66 may extend through the tube 118 partially or completely.

[0070] Referring here to Figures 8A-8J, the catheter system 10 may include an extension device 126 which may include an elongated body 128. In some embodiments, the elongated body 128 may include a fluid permeable structure 130 which may be configured to allow fluid to enter the distal end 18 of the catheter 24 in response to the extension device 126 being inserted through the catheter 24.

[0071] In some embodiments, the fluid permeable structure 130 of the extension device 126 may include grooves, as shown, for example, in Figures 8A-8D. In some embodiments, the fluid permeable structure 130 of the extension device 126 may include a flat region, as shown, for example, in Figures 8E-8F. In some embodiments, the flat region may include a generally planar upper surface 132 facing a generally planar lower surface 134. In some embodiments, the flat region may provide two inlets into the catheter 24. In some embodiments, the fluid permeable structure 130 of the extension device 126 may include a plurality of side holes 136 that can be connected by the lumen of the elongated body 128.

[0072] In some embodiments, the extension device 126 may be rigid. In some embodiments, the elongated body 128 may have a shape having a plurality of arms 138 that extend apart from each other and are angled to each other, as shown, for example, in Figure 8H-8I. In some embodiments, the shape of the elongated body 128 may vary. In some embodiments, a gap 140 may be located between the outer diameter of the extension device 126 and the distal opening 90 of the catheter 24, which may allow blood to flow from the vascular system proximal through the gap 140. In some embodiments, a blood collection device may be coupled to the proximal end of the extension tube 40.

[0073] Referring here to Figure 9-10, the delivery device 146 may include a hub 115 located within the housing 50, which may include guide features. In some embodiments, the delivery device 146 may be similar to, or identical to, the delivery device 12 disclosed in Figure 1-5, the delivery device 100 disclosed in Figure 6, and the delivery device 108 disclosed in Figure 7 in terms of one or more included components and / or operation.

[0074] In some embodiments, the hub 115 may extend through the slot 56. In some embodiments, the guide feature may include a channel, which may generally be U-shaped. In some embodiments, the guide feature, the hub 115, the channel, and other features of the delivery device 146 may be further illustrated, for example, in U.S. Patent Application No. 62 / 696,229, filed July 10, 2018, entitled “Delivery Device for Vascular Access Instruments,” which is incorporated herein by reference in its entirety. In some embodiments, the guide feature may include a forward tab 119 configured to be moved by the user’s hand.

[0075] In some embodiments, the delivery device 146 may include a guidewire 48 located within the housing 50 and extending through a guide feature. For example, in some embodiments, the guidewire 48 may extend through a channel. In some embodiments, in response to a first distance distal movement of the guide feature along the slot 56, the distal end 60 of the guidewire 48 may advance distally by a second distance, which may be greater than the first distance. In some embodiments, the second distance may be twice the first distance.

[0076] In some embodiments, the proximal end 58 of the guidewire 48 may be stationary relative to the housing 50. In some embodiments, the proximal end 58 may be fixed within the housing 50. In some embodiments, the distal end 60 may advance distally beyond the distal end of the housing 50 in response to the guide feature being partially and / or completely advanced distally along the slot 56. In these and other embodiments, the housing 50 may include an extension tube 40 that extends outward from the distal portion of the housing 50 and can be coupled to a blood collection device.

[0077] As illustrated in Figures 10A-10B, in some embodiments, the delivery device 146 may include a tube 102 that may extend from and be coupled to the hub 115. In some embodiments, in response to distal movement of the guide feature along the slot 56, the guidewire 48 may move through the tube 102. In some embodiments, in response to distal movement of the guide feature along the slot 56 by a first distance, the distal end 106 of the tube 102 may advance distally by a distance equal to the first distance ("1:1 advance ratio"), while the distal end 60 of the guidewire 48 may advance a distance greater than the first distance, for example, twice the first distance ("1:2 advance ratio"). In some embodiments, when the guidewire 48 and the tube 102 have fully advanced, the distal end 60 of the guidewire 48 may be distal to the distal tip 70 of the catheter 24. In these and other embodiments, the distal end 60 of the tube 102 may be positioned distal to the distal tip 70 of the catheter 24, at the same angle as the distal tip 70 of the catheter 24, or proximal to the distal tip 70 of the catheter 24.

[0078] In some embodiments, the partition wall 65 may be located at various positions within the distal end of the delivery device 146. For example, as shown in Figures 9A-9B, the partition wall 65 may be located proximal to the coupling point of the extension tube 40 and / or distal to the distal end of the slot 56. For example, as shown in Figures 10A-10B, the partition wall 65 may be located within the distal end of the housing 50 or within a connector coupled to the distal end of the housing 50. In some embodiments, the partition wall 65 may be located within the hub 115, as shown in Figure 10C. As shown in Figure 10C, in some embodiments, the extension tube 40 may extend proximal from the hub 115 and / or through the proximal end of the housing 50.

[0079] All examples and conditional language described herein are for educational purposes only to help the reader understand the present invention and the concepts to which the inventors have contributed to advance the art, and are construed as not being limited to such specifically described examples and conditions. While embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and modifications can be made herein without departing from the spirit and scope of the invention. It should be understood that any delivery device and / or one or more included components may be combined with one or more components of a catheter assembly described herein. It should be understood that one or more components of a particular delivery device may be combined with one or more components of another particular delivery device. For example, any fluid permeable structure described with respect to a particular delivery device may be combined with one or more components of another particular delivery device.

Claims

1. A delivery device for delivering instruments through an intravenous catheter assembly, Housing and An instrument configured to advance distally from the housing, Includes, The device comprises a guidewire and a tube, the guidewire being positioned within the tube, the guidewire having a proximal and distal end, the distal end of the guidewire having a fluid-permeable structure comprising an elongated core and a coil extending around the elongated core and coupled to the elongated core, the delivery device being configured such that, when coupled with the intravenous catheter assembly, the tube extends through the catheter into the patient's vascular system, and the fluid-permeable structure extends beyond the distal end of the catheter of the intravenous catheter assembly, the guidewire being movable within the tube, and the fluid-permeable structure being configurable to extend distally beyond the tube, A delivery device equipped with the following features.

2. The housing is equipped with a slot, The delivery device according to claim 1, further comprising a guide wire hub disposed within the housing, wherein the guide wire is fixed to the guide wire hub, and the guide wire hub is configured to move along the slot to advance the guide wire distally and distal to the distal end of the housing.

3. The delivery device according to claim 1, wherein the instrument has a rounded distal tip.

4. The delivery device according to claim 1, wherein the coil is fixed to the elongated core at a plurality of positions along the length of the elongated core.

5. The delivery device according to claim 1, wherein the spacing between the rings of the coil is generally uniform.

6. The delivery device according to claim 1, wherein the spacing between the rings of the coil changes.

7. The elongated core comprises a first portion having a first outer diameter and a second portion having a second outer diameter. The delivery device according to claim 1, wherein the second outer diameter is larger than the first outer diameter, and the second portion is positioned proximal to the catheter.

8. The delivery device according to claim 1, wherein the coil has a distal end and a proximal end, and the distal end of the coil is positioned distal to the distal end of the elongated core.

9. The delivery device according to claim 8, wherein the distal end of the coil is open.

10. The delivery device according to claim 8, wherein the distal end of the coil is closed.

11. The delivery device according to claim 2, wherein the distal end of the housing is provided with a connector, and the distal end of the housing or the connector is provided with a partition wall to prevent fluid from flowing into the distal end of the housing.

12. It is a catheter system, An apparatus comprising a guide wire and a tube, wherein the guide wire is disposed within the tube, and the guide wire has a proximal end and a distal end, and the distal end of the guide wire has a fluid-permeable structure comprising an elongated core and a coil extending around the elongated core and coupled to the elongated core, A catheter assembly comprising a catheter adapter having a distal end and a proximal end, and a lumen extending between the distal end and the proximal end, A catheter comprising: a catheter fixed to the catheter adapter and extending distally from the catheter adapter, having a distal end and a proximal end; The distal end of the instrument is configured to be positioned distal to the distal end of the catheter. A catheter system in which the tube extends into the patient's vascular system through the catheter, the guidewire is movable within the tube, and the fluid permeable structure can be positioned to extend distally beyond the tube.

13. The catheter system according to claim 12, further comprising a delivery device coupled to the catheter assembly, wherein the delivery device comprises the instrument and delivers the instrument into the catheter, the delivery device comprises a housing, and the blood collection path of the catheter system passes outside the housing.

14. The catheter system according to claim 12, wherein the coil of the fluid-permeable structure has a distal end and a proximal end, and the elongated core has a distal end and a proximal end, and the distal end of the coil and the distal end of the elongated core are configured to be positioned distal to the distal end of the catheter.

15. The catheter system according to claim 12, further comprising a gap between the outer diameter of the guide wire and the inner diameter of the catheter.

Images