Vascular access devices and related devices having fluid permeable structures

Abstract

A delivery device (12) for delivering a guide wire (48) through an intravenous catheter assembly includes a housing (50) including a distal end (52), a proximal end (54) and a slot (56). The delivery device includes a guide wire (48), which includes a proximal end (58) and a distal end (60). The delivery device includes a guide wire seat (62) disposed in the housing. The guide wire is fixed to the guide wire seat, and the guide wire seat is configured to move along the slot to advance the guide wire in a distal direction. The distal end of the guide wire 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, wherein the space between the elongated core and the coil is configured to receive blood in response to the guide wire being inserted into the vascular system.

Description

Background Art

[0001] Infusion therapy is a common healthcare procedure that can be facilitated by a vascular access device. Hospitalized, home care, and other patients receive fluids, medications, and blood products through a vascular access device inserted into the vascular system. Blood draws are another common healthcare procedure that can be facilitated by a vascular access device.

[0002] A vascular access device can be placed into a patient's peripheral or central vascular system. A vascular access device can be left in place for a short period (a few days), medium period (a few weeks), or long period (a few months to a few years). A vascular access device can be used for continuous infusion therapy or intermittent therapy.

[0003] A common type of vascular access device is an over-the-needle peripheral venous catheter (PIVC). As the name implies, an "over-the-needle" PIVC can be mounted on an introducer needle with a sharp distal tip. The sharp distal tip can be used to pierce the patient's skin and vascular system. Insertion of the PIVC into the vascular system can be performed after the needle is inserted into the vascular system. The needle and PIVC are typically inserted through the skin into the patient's vascular system at a slight angle, with the bevel of the needle facing away from the patient's skin. Once placement of the needle in the vascular system has been confirmed, the clinician can temporarily occlude blood flow in the vascular system and withdraw the needle, leaving the PIVC in place for future infusions and / or blood draws.

[0004] Currently, there may be several limitations to using a PIVC for infusions or blood draws. Over time, the PIVC or vein may narrow, collapse, or become blocked, causing the PIVC to fail. Also, blood drawn from a PIVC may often need to be discarded due to concerns about sample quality, which can result in an unusable sample and the need for repeat blood draws. Additionally, drawing blood using a PIVC can be slow and somewhat inefficient, especially when the patient has difficult venous access or has a vein that is not easily accessible to the clinician.

[0005] The subject matter claimed herein is not limited to embodiments that solve any disadvantages or that operate only in environments such as those described above. Rather, this background is merely provided to illustrate one exemplary technology area where some embodiments described herein may be practiced. Summary of the invention

[0006] The present disclosure generally relates to vascular access systems, devices and methods. More particularly, in some embodiments, the present disclosure relates to systems, devices and methods for placing an instrument through a catheter, which can be indwelling. In some embodiments, the instrument can include a guidewire. In some embodiments, the catheter can include a PIVC, a midline catheter, or a peripherally inserted central catheter (PICC).

[0007] In some embodiments, the apparatus can extend beyond the distal end or distal tip of the catheter, which can move or push away anything in the patient's vascular system that may block the catheter during blood draw. For example, the apparatus can move or push away fibrin material, thrombus or even vein wall. In some embodiments, the apparatus can push away the valve in the vascular system, allowing blood to flow back into the catheter. In some embodiments, the apparatus can open the distal end of the catheter. In some embodiments, the apparatus can reduce the kink of the catheter and the flow restriction caused by the kink of the catheter. In some embodiments, the apparatus can extend beyond the distal end of the catheter and the insertion site of the catheter, which can help bypass the local vein diameter restriction caused by thrombus and / or vein structure. In some embodiments, the apparatus can move the distal end of the catheter away from the vein wall to the center of the vein, which can reduce the chance of causing the vein wall to be blocked and / or damaged due to the shear stress caused by the flow.

[0008] In some embodiments, the apparatus may include a fluid permeable structure that may provide a long and narrow entry path or multiple entry paths into the distal end of the catheter. In some embodiments, the fluid permeable structure may prevent fibrin material, thrombus or other material from blocking the distal end of the catheter. In some embodiments, the apparatus may increase the indwelling time of the catheter. In some embodiments, the apparatus may allow the catheter to be made of a softer and / or more flexible material, which may be gentler to the vascular system. In some embodiments, the apparatus may allow blood to enter the catheter from a longer portion of the vein and may reduce the blood sampling fill time, especially for small gauge catheters.

[0009] In certain embodiments, guide wire can be delivered by intravenous catheter assembly via any suitable delivery device.In certain embodiments, the delivery device in order to deliver the guide wire by intravenous catheter assembly can include housing, and housing can include distal end, proximal end and slot.In certain embodiments, delivery device can include guide wire, and guide wire can include proximal end and distal end.In certain embodiments, the distal end of guide wire can include described fluid permeable structure.

[0010] In some embodiments, the delivery device may include a guide wire seat that may be disposed in the housing. In some embodiments, the guide wire may be fixed to the guide wire seat. In some embodiments, the guide wire seat may be configured to move along the slot to advance the guide wire in a distal direction toward the distal end of the housing. In some embodiments, the guide wire may advance in a distal direction and / or be withdrawn in a proximal direction.

[0011] 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 guide wire being inserted into the vascular system, blood may flow in 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 guide wire and the inner diameter of the conduit, which may allow blood to flow through the gap from the vascular system to the proximal side.

[0012] In certain embodiments, guide wire can comprise the distal end of chamfering, and when guide wire is inserted into vascular system, the distal end of chamfering can reduce the risk of damaging vascular system.In certain embodiments, the distal end of chamfering can reduce the risk of thrombosis or other complications.In certain embodiments, the distal end of chamfering can be spot welded, bonding or formed by another suitable mode.In certain embodiments, the distal end of chamfering can be made of metal, plastic, elastomer or other suitable materials.

[0013] In some embodiments, the coil can be fixed to the elongated core at one or more positions along the length of the elongated core. For example, one or more bridges can 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 can be connected to the elongated core via a rounded distal tip. In more detail, in some embodiments, the distal end of the coil can be directly connected to the rounded distal tip, and the rounded distal tip can be directly connected to the elongated core.

[0014] In some embodiments, the coil can be tightly wound around the elongated core at one or more positions to connect the coil to the elongated core. In some embodiments, the coil can include a distal end and a proximal end. In some embodiments, the distal end of the coil and / or the proximal end of the coil can be tightly wound around the elongated core. In some embodiments, the elongated core can include a first portion and a second portion, the first portion can include a first outer diameter, and the second portion can include a second outer diameter. In some embodiments, the second outer diameter can be greater than the first outer diameter. In some embodiments, the coil can be tightly wound around the second portion.

[0015] In some embodiments, the spacing between the loops of the coil can be substantially uniform. In some embodiments, the spacing between the loops of the coil can be variable. In some embodiments, along one or more parts of the coil, the spacing of the loop can be compact. For example, the loops can contact each other or be close to each other. In some embodiments, along other parts of the coil, the spacing of the loop can be more separated than along this part of the coil. In some embodiments, the distal end of the coil can be arranged on the far side of the distal end of the elongated core. In these and other embodiments, the distal end of the coil can be open or closed.

[0016] In some embodiments, the delivery device may include a pipeline, and the pipeline may include a proximal end and a distal end. In some embodiments, a guide wire may be delivered through the catheter assembly via any suitable delivery device. In some embodiments, the pipeline may be configured to extend into the vascular system of the catheter and / or the patient. In some embodiments, the guide wire may be arranged in the pipeline. In some embodiments, the distal end of the pipeline may include a fluid permeable structure. In some embodiments, a guide wire and / or pipeline may reduce the number of acupunctures suffered by the patient, because the catheter may not be replaced so frequently. In some embodiments, when the catheter no longer works or is not too effective due to, for example, accumulation of debris on the distal end of the catheter or collapse of the catheter, the pipeline may allow the user to extract a blood sample or infuse fluid through the catheter.

[0017] In some embodiments, the delivery device may include a conduit seat disposed within the housing. In some embodiments, the conduit may be secured to the conduit seat. In some embodiments, the conduit seat may be configured to move along the slot to advance the conduit in a distal direction distal to the distal end of the housing. In some embodiments, the conduit may be advanced in the distal direction any number of times and / or withdrawn in the proximal direction any number of times.

[0018] In some embodiments, a catheter system may include a delivery device and a catheter assembly. In some embodiments, the catheter assembly may include a catheter adapter, and the catheter adapter may include a distal end, a proximal end, and an inner cavity extending between the distal end and the proximal end. 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 path for blood to enter the catheter.

[0019] In some embodiments, the catheter adapter may include a side port that may be angled relative to the distal end of the catheter adapter. In some embodiments, the catheter system may include an extension tube that may include 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, the fluid permeable structure may facilitate blood entry into the catheter in response to a negative pressure applied to the side port of the catheter adapter.

[0020] In some embodiments, the connector can be coupled to the proximal end of the extension tube. In some embodiments, the proximal end of the extension tube can be integral with the connector. In some embodiments, the connector can include a first port and a second port. In some embodiments, the connector can include more than two ports. In some embodiments, a delivery device can be coupled to the first port of the connector. In some embodiments, another extension tube can be coupled to the second port of the connector. In some embodiments, a blood collection device can be coupled to the proximal end of another extension tube.

[0021] In some embodiments, blood can be prevented from entering the delivery device. For example, the distal end of the housing may include a septum 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 following: a catheter, a catheter adapter, an extension tube, and another extension tube. In some embodiments, blood can be collected via a fluid pathway, which may not extend through the housing of the delivery device. In some embodiments, the fluid pathway may not include a large portion or the entirety of the housing, or may not be arranged within a large portion or the entirety of the housing. In some embodiments, blood may not flow within the housing of the delivery device, or may not flow through the housing of the delivery device. In some embodiments, the delivery device may not be a blood collection device; rather, the delivery device may facilitate blood flow through the catheter and allow blood to be collected through a fluid pathway, which may include a catheter assembly, and / or may not include the housing of the delivery device.

[0022] In some embodiments, the delivery device can be coupled to the proximal end of the catheter adapter. In these embodiments, the fluid pathway of the catheter system can include a catheter, a catheter adapter, and an extension tube. In some embodiments, the blood collection device can be coupled to the proximal end of the extension tube.

[0023] In some embodiments, an instrument of a catheter system may include an extension device, which may include an elongated body. In some embodiments, the extension device may be similar to an occluder, except that the extension device may not block the fluid passage through the catheter; instead, the extension device may facilitate fluid flow 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 extending 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 extending channels.

[0024] It should be understood that the foregoing general description and the following detailed description are exemplary and explanatory and are not limitations of the claimed invention. It should be understood that the various embodiments are not limited to the arrangements and mechanisms shown in the accompanying drawings. It should also be understood that these 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 invention, unless so required. Therefore, the following detailed description should not be regarded as having a limiting meaning. BRIEF DESCRIPTION OF THE DRAWINGS

[0025] Example embodiments will be described and explained with additional particularity and detail through the use of the accompanying drawings, in which:

[0026] Figure 1A is an upper perspective view of an exemplary catheter system according to some embodiments;

[0027] Figure 1B According to some embodiments Figure 1A An upper perspective view of an exemplary delivery device of a catheter system of FIG. 1 , showing an exemplary guidewire in a retracted position;

[0028] Figure 1C According to some embodiments Figure 1A An upper perspective view of a delivery device of a catheter system of , showing a guidewire in an advanced position;

[0029] Figure 1D According to some embodiments Figure 1A A cross-sectional view of a delivery device of a catheter system of , showing a guidewire in a withdrawn position;

[0030] Figure 1E According to some embodiments Figure 1A A cross-sectional view of a delivery device of a catheter system of , showing a guidewire in an advanced position;

[0031] Figure 1F According to some embodiments Figure 1A An enlarged upper perspective view of a portion of a catheter system of , showing a guidewire in an advanced position;

[0032] Figure 1G According to some embodiments Figure 1A An upper perspective view of an exemplary distal end of a catheter system of , showing a guidewire in an advanced position;

[0033] Figure 1H According to some embodiments Figure 1A A cross-sectional view of an exemplary distal end of a catheter system of , showing a guidewire in an advanced position and disposed within a patient's vasculature;

[0034] Figure 2AAccording to some embodiments Figure 1A An upper perspective view of an exemplary distal end of a guidewire of a catheter system;

[0035] Figure 2B According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a guidewire of a catheter system;

[0036] Figure 2C According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a guidewire of a catheter system;

[0037] Figure 2D According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a guidewire of a catheter system;

[0038] Figure 2E According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a guidewire of a catheter system;

[0039] Figure 2F According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a guidewire of a catheter system;

[0040] Figure 2G According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a guidewire of a catheter system;

[0041] Figure 3A According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a catheter system of , showing an exemplary diffusion hole and a guidewire in an advanced position;

[0042] Figure 3B According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a catheter system of , showing a diffusion hole and a guidewire in an advanced position;

[0043] Figure 4A According to some embodiments Figure 1A An upper perspective view of another exemplary catheter assembly of a catheter system of FIG.

[0044] Figure 4B According to some embodiments Figure 1A An upper perspective view of a delivery device of a catheter system;

[0045] Figure 5A According to some embodiments Figure 1AAn upper perspective view of a catheter system of , showing an exemplary syringe;

[0046] Figure 5B According to some embodiments Figure 1A An upper perspective view of a catheter system of , showing replacement of a syringe with a blood collection tube;

[0047] Fig. 6A According to some embodiments, Figure 1A An upper perspective view of another delivery device for use with a catheter system;

[0048] Figure 6B According to some embodiments Fig. 6A A cross-sectional view of another delivery device;

[0049] Figure 6C According to some embodiments Fig. 6A A cross-sectional view of another delivery device coupled to another exemplary catheter assembly showing a partially advanced guidewire;

[0050] Fig. 7A According to some embodiments Figure 1A an upper perspective view of another delivery device coupled to the catheter system;

[0051] Figure 7B According to some embodiments Fig. 7A A cross-sectional view of a delivery device of , showing a guidewire and an exemplary conduit in an advanced position;

[0052] Figure 7C is connected to Figure 1A of the catheter system Fig. 7A An upper perspective view of a delivery device;

[0053] Fig.7D is connected to Figure 1A of the catheter system Fig. 7A A cross-sectional view of a delivery device;

[0054] Fig. 7E According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a catheter system;

[0055] Figure 7F According to some embodiments Fig. 7E an enlarged upper perspective view of the other distal end of

[0056] Figure 7G According to some embodiments Figure 1A An upper perspective view of another exemplary distal end of a catheter system;

[0057] Figure 7H According to some embodiments Figure 7G an enlarged upper perspective view of the other distal end of

[0058] Fig. 8A is an upper perspective view of an exemplary distal end of an exemplary extension device according to some embodiments;

[0059] Figure 8B According to some embodiments, Fig. 8A A cross-sectional view of the distal end portion taken along line 8B-8B;

[0060] Figure 8C According to some embodiments Fig. 8A An upper perspective view of another exemplary distal end of an extension device;

[0061] Fig.8D According to some embodiments, Figure 8C A cross-sectional view of the other distal end taken along line 8D-8D;

[0062] Fig. 8E According to some embodiments Fig. 8A An upper perspective view of another exemplary distal end of an extension device;

[0063] Fig.8F According to some embodiments, Fig. 8E A cross-sectional view of the other distal end taken along line 8F-8F;

[0064] Figure 8G According to some embodiments Fig. 8A An upper perspective view of another exemplary distal end of an extension device;

[0065] Figure 8H According to some embodiments Fig. 8A An upper perspective view of another exemplary distal end of an extension device;

[0066] Figure 8I According to some embodiments, Figure 8H A cross-sectional view of the other distal end taken along line 8I-8I;

[0067] Figure 8J is a cross-sectional view of an exemplary catheter assembly according to some embodiments, showing another exemplary extension device;

[0068] Fig.9A is an upper perspective view of another delivery device showing a guidewire in a withdrawn position according to some embodiments;

[0069] Fig. 9B According to some embodiments Fig.9AAn upper perspective view of a delivery device of , showing the guidewire in an advanced position;

[0070] Fig. 10A is an upper perspective view of another delivery device according to some embodiments, showing a guidewire and an exemplary conduit in a retracted position;

[0071] Fig. 10B According to some embodiments Fig. 10A An upper perspective view of a delivery device of , showing a guidewire and an exemplary conduit in an advanced position; and

[0072] Fig. 10C According to some embodiments Fig. 10A Cross-sectional view of an exemplary seat portion of a delivery device. DETAILED DESCRIPTION

[0073] As used in this disclosure, the term "distal" refers to the portion of the catheter system or its components that is farther from the user, and the term "proximal" refers to the portion 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, doctor, nurse, or any other care provider, and may include support personnel.

[0074] Now refer 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 delivery device, which may include any suitable housing. In some embodiments, the housing may include a collapsible tube or a flexible tube or any other suitable element that generally surrounds the instrument to promote a sterile environment. For example, the delivery device 12 may include a linear or rotary mechanism or any other suitable mechanism. In some embodiments, the delivery device 12 can be described in, for example, U.S. patent application No. 62 / 660,661, filed on April 20, 2018, entitled “INSTRUMENT DELIVERY DEVICE HAVING A ROTARY ELEMENT,” U.S. patent application No. 62 / 773,029, filed on November 29, 2018, entitled “SYRINGE-BASED DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT,” and U.S. patent application No. 62 / 696,229, filed on July 10, 2018, entitled “DELIVERY DEVICE FOR A VASCULAR ACCESS INSTRUMENT,” the entire contents of each of which are incorporated herein by reference.

[0075] 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, a catheter 24 may be secured 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 catheter (PICC).

[0076] In some embodiments, the delivery device 12 can be coupled to any suitable catheter assembly. In these and other embodiments, the catheter assembly 14 can include a straight or non-integrated catheter assembly. In some embodiments, the catheter assembly 14 can include an integral catheter assembly. In more detail, in some embodiments, the catheter adapter 16 of the catheter assembly 14 can include an integral extension tube, such as a BD NEXIVA TM Closed IV catheter system, BD NEXIVA TM DIFFUSICS TM Closed IV catheter system, or Becton Dickinson PEGASUS TM Safety closed IV catheter system.

[0077] like Figure 1A As shown, in some embodiments, the catheter adapter 16 can include a side port 26, which can be angled relative to the distal end 18 of the catheter adapter 16. In some embodiments, the catheter assembly 14 can include an extension tube 28, which can include a distal end 30 and a proximal end 32. In some embodiments, the extension tube 28 can be short to provide near-patient access. However, in some embodiments, the length of the extension tube 28 can vary. In some embodiments, the distal end 30 of the extension tube 28 can be coupled to the side port 26. In some embodiments, the distal end of the extension tube 28 can be integrated with the side port 26.

[0078] In some embodiments, connector 34 can be coupled to proximal end 32 of extension tube 28. In some embodiments, proximal end 32 of extension tube 28 can be integral with connector 34. In some embodiments, connector 34 can include a Y-adapter, a T-port, or other suitable connector. In some embodiments, connector 34 can include a male or female Luer connector with a Luer slip or Luer lock feature. In some embodiments, connector 34 can include more than two ports.

[0079] 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 disposed between the delivery device 12 and the connector 34. In some embodiments, the connector 34 and the needleless connector 39 may be integrally formed. In some embodiments, the needleless connector 39 may include any suitable needleless connector.

[0080] In some embodiments, the proximal end 42 of another extension tube 40 may include a connector 44, which can be connected to any suitable blood collection device, such as a syringe, a vacuum tube, a blood collection tube, a retainer, etc. 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 with a Luer slip or Luer lock feature. In some embodiments, the connector 44 may be connected to a retainer 46, which may be configured to receive another blood collection device. In some embodiments, the retainer 46 may include a cannula configured to pierce the seal of a specific blood collection device. In some embodiments, the connector 44 may be connected to a needleless connector 39, which may be connected to the retainer 46 or another blood collection device.

[0081] In some embodiments, the device can be delivered through the catheter assembly 14 by any suitable delivery device, which can include a guidewire 48. In some embodiments, the delivery device 12 can include a housing 50, which can include a distal end 52, a proximal end 54, and a slot 56, which can extend between the distal end 52 and the proximal end 54. In some embodiments, the delivery device 12 can include a guidewire 48, which can include a proximal end 58 and a distal end 60.

[0082] In some embodiments, the delivery device 12 can include a guidewire seat 62 that can be disposed within the housing 50. In some embodiments, the guidewire 48 can be secured to the guidewire seat 62. In some embodiments, the guidewire seat 62 can be configured to move along the slot 56 to advance the guidewire 48 in a distal direction distal to the distal end 52 of the housing 50. In some embodiments, the guidewire 48 can be advanced in a distal direction and / or withdrawn in a proximal direction. In some embodiments, the guidewire seat 62 and one or more other components of the delivery device 12 can be further described in U.S. Patent Application No. 62 / 660,646, filed on April 20, 2018, entitled “MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS,” the entire contents of which are incorporated herein by reference.

[0083] In some embodiments, blood can flow proximally from the catheter 24 to the catheter adapter 16, to the extension tube 28, and then to the other extension tube 40. In some embodiments, blood can be prevented from entering the delivery device 12. For example, the distal end 52 of the housing 50 may include a septum 65 to prevent fluid, such as blood, from flowing into the distal end 52 of the housing 50. In other embodiments, blood can be allowed to flow proximally through the housing 50, and the housing 50 may include a conduit connected to the blood collection device. In some embodiments, the distal end 52 of the housing 50 can be connected to a connector, which can include a male or female Luer connector with a Luer slip or Luer lock feature, or other suitable connector. In some embodiments, the septum 65 can be disposed within a connector connected to the distal end 52 of the housing 50, such as Figure 1D shown.

[0084] Now refer to Figures 1F-1H In some embodiments, the distal end 60 of the guidewire 48 can include a fluid permeable structure 64. In some embodiments, the fluid permeable structure 64 can include an elongated core 66 and a coil 68 extending around the elongated core 66. In some embodiments, in response to the guidewire 48 being inserted into the patient's vascular system, blood can flow in the space between the elongated core 66 and the coil 68.

[0085] In some embodiments, the guidewire 48 can be advanced beyond the distal tip 70 of the catheter 24, which can move or push away anything within the patient's vascular system that could obstruct the catheter 24 during a blood draw. For example, the guidewire 48 can move, push away, or move beyond fibrin material or a thrombus, or move the distal tip 70 of the catheter 24 away from a vein wall or valve. Figure 1HAs shown, in some embodiments, the guidewire 48 can push open a valve within the vascular system, allowing blood to flow back into the catheter 24. In some embodiments, the guidewire 48 can remain within the catheter 24 and extend beyond the distal tip 70 of the catheter during blood draws and / or infusions.

[0086] In some embodiments, the fluid permeable structure 64 may include a long, narrow entry path or multiple entry paths into the distal end 70 of the catheter 24. In some embodiments, the fluid permeable structure 64 may prevent fibrin material, thrombus, or another material from blocking the distal end 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 gap 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 end 70 of the catheter 24, which gap may allow blood to flow proximally from the vascular system through the gap.

[0087] In some embodiments, the catheter 24 and / or the catheter adapter 16 can be made of FEP, TEFLON, silicone, TPE, TPU, fluorinated polymers or other suitable materials. In some embodiments, the catheter 24 can be hydrophilic or hydrophobic. In some embodiments, the distal end of the catheter 70 can be asymmetric. In some embodiments, the catheter 24 can include an anti-thrombotic coating and / or an anti-fouling material.

[0088] Now refer to Figure 2A-2G In some embodiments, the coil 68 may include a metal wire arranged in a spiral shape around the elongated core 66. In some embodiments, the elongated core 66 may be solid and / or made of metal or other suitable materials. 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.

[0089] In some embodiments, the guide wire 48 may include a rounded distal end 72 that may reduce the risk of damaging the vascular system when the guide wire 48 (which may be flexible) is inserted into the vascular system. In some embodiments, the rounded distal end 72 may reduce the risk of thrombosis or other complications. In some embodiments, the rounded distal end 72 may be spot welded or formed by another suitable means and / or material.

[0090] 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 the elongated core 66 via a rounded distal tip 72. In more detail, in some embodiments, the distal end of the coil 68 may be directly coupled to the rounded distal tip 72, which may be directly coupled to the elongated core 66.

[0091] In some embodiments, the coil 68 can be tightly wound around the elongated core 66 at one or more locations to couple the coil 68 to the elongated core 66. In some embodiments, the distal end 74 of the coil 68 can be tightly wound around the elongated core 66. In some embodiments, the proximal end 76 of the coil 68 can be tightly wound around the elongated core 66, e.g. Figure 2A shown.

[0092] In some embodiments, the elongated core 66 may include a first portion 78 and a second portion 80, the first portion may include a first outer diameter, and the second portion may include a second outer diameter. In some embodiments, the second outer diameter may be greater than the first outer diameter. In some embodiments, the coil 68 may be tightly wound around the second portion 80, for example, as Figure 2F In some embodiments, the elongated core 66 can be tapered or stepped between the first portion 78 and the second portion 80. In some embodiments, the guidewire 48 can include multiple diameters along its length, depending on, for example, the corresponding inner diameter of the catheter assembly 14. In some embodiments, the elongated core 66 can include a uniform outer diameter along its entire length, for example, Figure 2G shown.

[0093] In some embodiments, the spacing between the loops 82 of the coil 68 may be substantially uniform, e.g. Figure 2A-2B In some embodiments, the spacing between the loops 82 of the coil 68 may be varied. For example, Figure 2D As shown, in some embodiments, along one or more portions of the coil, the spacing of the loops 82 may be dense or close (e.g., the loops 82 may be touching or close to each other), while along other portions of the coil 68, the spacing of the loops may be further apart than along the one or more portions of the coil 68.

[0094] For example, Figure 2EAs shown, in some embodiments, the distal end 74 of the coil 68 can be disposed on the far side of the distal end 84 of the elongated core 66. In these and other embodiments, the distal end 74 of the coil 68 can be open or closed. In some embodiments, the distal end 74 of the coil 68 can be closed by, for example, a rounded distal end 72. In some embodiments, the distal end 74 of the coil 68 can be closed by spot welding, adhesives, overmolding, coupling with plastic or elastomer ends, or other suitable methods. In some embodiments, the distal end 84 of the elongated core 66 can be blunt or rounded.

[0095] For example, Figure 2F As shown, in some embodiments, the coil 68 can be secured to the elongated core 66 at one or more locations along the length of the elongated core 66. For example, one or more bridges 86 can extend from the coil 68 to the elongated core 66 to secure the coil 68 to the elongated core 66 at one or more locations along the length of the coil 68. In these and other embodiments, the elongated core 66 can extend along the central axis of the coil 68. In some embodiments, the delivery device 12 can include any suitable elongated core and / or any suitable coil. In some embodiments, the bridge 86 can be formed by welding, an adhesive, or another suitable manner.

[0096] 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 a plurality of contact locations along the length of the coil 68, and / or may be coupled to the coil 68 at one or more of the plurality of contact locations. In some embodiments, the elongated core 66 may be coupled to the coil 68 by welding, adhesive, or other suitable means.

[0097] Now refer to Figure 3A-3B In some embodiments, the catheter 24 may include one or more diffusion holes 88 that may provide an additional path 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 a portion of the catheter 24. In some embodiments, the coil 68 may extend proximally beyond the diffusion holes 88. In some embodiments, the coil 68 may not extend proximally beyond the diffusion holes 88.

[0098] In some embodiments, the second portion 80 can be disposed proximal to the distal opening 90 of the catheter 24. In some embodiments, the delivery device 12 can include a gap 93 between the outer diameter of the guidewire 48 and the distal opening 90 of the catheter 24, which can allow blood to flow proximally from the vasculature through the gap 93. In some embodiments, the size of the elongated core 66 can be sized according to the specific catheter gauge size with which it can be used.

[0099] In some embodiments, the outer diameter of the coil 68 and / or the elongated core 66 can be variable, tapered, or straight. In some embodiments, the outer diameter of the coil 68 can be greater than the diameter of the distal opening 90 of the catheter 24, and the coil 68 can be compressible.

[0100] Now refer to Figure 4A In some embodiments, the delivery device 12 can be coupled to a proximal port of a T-connector 91, which can include a needleless connector. In some embodiments, the distal port of the T-connector 91 can be coupled to the proximal end 20 of the catheter adapter 16. In these and other embodiments, the catheter adapter 16 can include no side port 26 and / or an integral extension tube. In some embodiments, the extension tube 28 can be coupled to a side port of the T-connector, which can be angled relative to the proximal and distal ports.

[0101] 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 coupled to a connector 92, which may be coupled to any suitable blood collection device. In some embodiments, the connector 92 may include a male or female Luer connector having a Luer slip or Luer lock feature. In some embodiments, the connector 92 may be coupled to a needleless connector 39, which may be coupled to a retainer 46 or another blood collection device.

[0102] In some embodiments, connector 92 can be coupled to holder 46, which can be configured to receive a specific blood collection device, such as a blood collection tube, vacuum tube, or syringe. In some embodiments, holder 46 can include a cannula configured to pierce the seal of a specific blood collection device.

[0103] Now refer to Figure 4BIn some embodiments, the extension tube 40 can extend from the delivery device 12. For example, a connector coupled to the distal end 52 of the housing 50 can include a port, or the housing 50 can include a port. In some embodiments, the extension tube 40 can be coupled to the port and / or be integral with the port. In some embodiments, the delivery device 12 can include a septum at the distal end of the housing 20 or within the connector. In some embodiments, the septum can be located proximal to the port, which can prevent blood from moving proximal to the septum and preventing blood from traveling through a majority of the housing 50.

[0104] Now refer to Figure 5A , the holder 46 is shown coupled to an exemplary flushing syringe 94, which may be pre-filled with saline. Referring now to Figure 5B , the holder 46 is shown coupled to an exemplary blood collection tube 96. In some embodiments, after using the flushing syringe 94 to flush the conduit 24 to ensure patency and draw the initial waste sample into the flushing syringe, the flushing syringe 94 can be connected to the connector 34 (or related Figure 4A The connector 92 discussed above is disconnected and a blood collection tube 96 or other suitable blood collection device can be connected to the connector 92.

[0105] Now refer to Figures 6A-6C , in some embodiments, a delivery device 100 according to some embodiments is shown. In some embodiments, the delivery device 100 can be similar or identical to the delivery device 12 disclosed in FIGS. 1-5 of the present disclosure in terms of one or more included components and / or operation. In some embodiments, the delivery device 100 can include a conduit 102, which can include a proximal end 104 and a distal end 106.

[0106] In some embodiments, conduit 102 can be configured to extend into and / or through conduit 24 into the patient's vascular system. In some embodiments, guidewire 48 can be disposed within conduit 102 and / or can extend distally through conduit 102 as guidewire 48 is advanced. In some embodiments, guidewire 48 can be fully retracted as conduit 102 is advanced, e.g. Figure 6A-6B In some embodiments, the guidewire 48 and the tube 102 can be advanced and / or withdrawn simultaneously.

[0107] In some embodiments, the guidewire and / or tubing 102 can reduce the number of needle sticks suffered by the patient because the catheter can be replaced less frequently. In some embodiments, tubing 102 can allow a user to draw a blood sample or infuse fluid through catheter 24 when catheter 24 is no longer functioning or is less effective due to, for example, debris accumulated on the distal end of catheter 24 or due to catheter 24 collapse.

[0108] In some embodiments, the delivery device 100 may include a conduit seat 107 disposed within the housing 50. In some embodiments, the conduit 102 may be secured to the conduit seat 107. In some embodiments, the conduit seat 107 may be configured to move along the slot 56 to advance the conduit 102 in a distal direction distal to the distal end 52 of the housing 50. In some embodiments, the conduit 102 may be advanced in a distal direction and / or withdrawn in a proximal direction. In some embodiments, the conduit 102, the guidewire seat 62, the conduit seat 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 on April 20, 2018, entitled “MULTI-DIAMETER CATHETER AND RELATED DEVICES AND METHODS,” the entire contents of which are incorporated herein by reference.

[0109] Now refer to Figures 7A-7D , in some embodiments, a delivery device 108 according to some embodiments is shown. In some embodiments, the delivery device 108 can be similar to the delivery device 12 and / or the delivery device 12 disclosed in FIGS. 1-5 of the present disclosure in terms of one or more of the included components and / or operations. Figures 6A-6C The delivery device 100 disclosed in is similar or identical to that disclosed in .

[0110] In some embodiments, the delivery device 108 may include a conduit 110, which may include a proximal end 112 and a distal end 114. In some embodiments, the proximal end 112 of the conduit 110 may be coupled to a connector 116, which may include a male or female Luer connector having a Luer slip or Luer lock feature. 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 retainer 46, which may be configured to receive another blood collection device. In some embodiments, the proximal end 58 of the guidewire 48 and / or the distal end 114 of the conduit 110 may be fixed in a seat 115.

[0111] In some embodiments, the proximal end of the tubing 102 can be secured within the seat 115. In some embodiments, the guidewire 48 can be longer than the tubing 102 and can extend distally beyond the distal end 52 of the housing 50.

[0112] In some embodiments, the seat 115 can include an advancement tab 119 positioned within the slot 56. In some embodiments, the seat 115 can be moved distally within the slot 56 to advance the guidewire 48 and the tubing 102 simultaneously in the distal direction. Figures 7B-7DThe guidewire 48 and tubing 102 are shown fully advanced in the distal direction according to some embodiments. In some embodiments, the seat 115 can be moved proximally to withdraw the guidewire 48 and tubing 102. In some embodiments, in response to the tubing 102 being fully advanced in the distal direction, the distal end 106 of the tubing 102 can be positioned proximal to the distal tip 70 of the catheter 24 or terminate proximal to the distal tip of the catheter, which can allow the tubing 102 to include a larger outer diameter in the fully advanced position and / or provide improved visualization of the distal end 114.

[0113] In some embodiments, in response to the tubing 102 being fully advanced in the distal direction, the distal end 106 of the tubing 102 can be positioned or terminated distal to the distal tip 70 of the catheter 24, or even together with the distal tip 70, proximal to the distal tip 70, near the catheter wedge, or near the catheter wedge in the catheter adapter 16. In some embodiments, the outer diameter of the distal end 106 can provide a seal wherever it terminates, which can reduce mixing of the drawn blood with the fluid in the catheter assembly 14, reducing waste volume. In some embodiments, in response to the tubing 102 being fully advanced in the distal direction, the distal end 106 of the tubing 102 can be positioned anywhere within the fluid pathway. In some embodiments, the coil 68 can be disposed within the tubing 102.

[0114] Now refer to Figure 7E-7H In some embodiments, in addition to or as an alternative to the coil 68, the guidewire 48 may include a tube 118. In some embodiments, the tube 118 may include the fluid permeable structure 64. For example, in some embodiments, the tube 118 may be porous. Fig. 7E As shown, in some embodiments, the tube 118 can include a plurality of holes 120, which can be arranged in various patterns and quantities and can include various sizes. In some embodiments, the holes 120 can be disposed on the distal end 122 of the tube 118. In some embodiments, the holes 120 can be arranged in staggered rows.

[0115] In some embodiments, the distal end 122 of the tube 118 can be open or closed. In some embodiments, the distal end 122 of the tube 118 can be coupled to the rounded distal tip 72. In some embodiments, the proximal end 123 of the tube 118 can be disposed within the catheter 24 and / or can be tapered. In some embodiments, the proximal end 123 of the tube 118 can include one or more holes 125 that can be larger and / or smaller than the hole 120. In some embodiments, the proximal end 123 of the tube 118 can be coupled to the elongated core 66.

[0116] like Figure 7GAs shown, in some embodiments, the tube 118 can include a plurality of slits 124, which can be arranged in various patterns and quantities and can include various sizes. In some embodiments, the slits 124 can be disposed on the distal end 122 of the tube 118. In some embodiments, the slits 124 can be arranged in staggered rows. In some embodiments, the slits 124 can be cut substantially perpendicular to the longitudinal axis of the catheter 24, but in some embodiments, the angles of the slits 124 can vary. In some embodiments, the elongated core 66 can extend partially or completely through the tube 118.

[0117] Now refer to Figures 8A-8J , catheter system 10 can include extension device 126, which can include elongated body 128. In some embodiments, elongated body 128 can include a fluid permeable structure 130 that can be configured to allow fluid to enter distal end 18 of catheter 24 in response to extension device 126 being inserted through catheter 24.

[0118] In some embodiments, the fluid permeable structure 130 of the extension device 126 may include grooves, such as Figures 8A-8D In some embodiments, the fluid permeable structure 130 of the extension device 126 may include a flat area, such as Figures 8E-8F In some embodiments, the flat region can include a generally flat upper surface 132 opposite a generally flat lower surface 134. In some embodiments, the flat region can provide two entrances into the catheter 24. In some embodiments, the fluid permeable structure 130 of the extension device 126 can include a plurality of side holes 136 that can be connected through the lumen of the elongated body 128.

[0119] In some embodiments, the extension device 126 can be solid. In some embodiments, the elongated body 128 can include a shape having a plurality of arms 138 extending away from each other and at an angle relative to each other, such as Figures 8H-8I In some embodiments, the shape of the elongated body 128 can vary. In some embodiments, a gap 140 can be provided between the outer diameter of the extension device 126 and the distal opening 90 of the catheter 24, which can allow blood to flow proximally from the vascular system through the gap 140. In some embodiments, a blood collection device can be coupled to the proximal end of the extension tube 40.

[0120] Now refer to Figures 9A-10C , the delivery device 146 may include a seat 115 disposed within the housing 50, which may include a guide feature. In some embodiments, the delivery device 146 may be similar to the delivery devices 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 28, 29, 30, 31, 32, 33, 34, 35, 36, 37, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54, 55, 56, 57, 58, 59, 60, 61, 62, Figures 6A-6C The delivery device 100 disclosed in Figures 7A-7H The delivery device 108 disclosed in is similar or identical to that disclosed in .

[0121] In some embodiments, the seat 115 can extend through the slot 56. In some embodiments, the guide feature can include a channel, which can be generally U-shaped. In some embodiments, the guide feature, the seat 115, the channel, and other features of the delivery device 146 can be further shown, for example, in U.S. Patent Application No. 62 / 696,229, entitled “DELIVERY DEVICE FOR AVASCULAR ACCESS INSTRUMENT,” filed on July 10, 2018, the entire contents of which are incorporated herein by reference. In some embodiments, the guide feature can include an advancement tab 119, which can be configured to be moved by a user's hand.

[0122] In some embodiments, the delivery device 146 can include a guidewire 48 disposed within the housing 50 and extending through the guide feature. For example, in some embodiments, the guidewire 48 can extend through the passage. In some embodiments, in response to the guide feature moving a first distance in the distal direction along the slot 56, the distal end 60 of the guidewire 48 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 twice the first distance.

[0123] In some embodiments, the proximal end 58 of the guidewire 48 can be fixed relative to the housing 50. In some embodiments, the proximal end 58 can be fixed within the housing 50. In some embodiments, the distal end 60 can be advanced in the distal direction beyond the distal end of the housing 50 in response to the guide feature being partially and / or completely advanced in the distal direction along the slot 56. In these and other embodiments, the housing 50 can include an extension tube 40 that can extend outward from the distal portion of the housing 50 and can be coupled to a blood collection device.

[0124] like Figures 10A-10BAs shown, in some embodiments, the delivery device 146 can include a conduit 102 that extends from and is coupled to the seat 115. In some embodiments, in response to the guide feature moving in the distal direction along the slot 56, the guidewire 48 can move through the conduit 102. In some embodiments, in response to the guide feature moving in the distal direction along the slot 56 a first distance, the distal end 106 of the conduit 102 can be advanced in the distal direction a distance equal to the first distance (a "1:1 advancement ratio"), and the distal end 60 of the guidewire 48 can be advanced a distance greater than the first distance, such as twice the first distance (a "1:2 advancement ratio"). In some embodiments, when the guidewire 48 and the conduit 102 are fully advanced, the distal end 60 of the guidewire 48 can be located distal to the distal tip 70 of the catheter 24. In these and other embodiments, the distal end 60 of the tube 102 can be disposed distal to, even along with, or proximal to the distal tip 70 of the catheter 24 .

[0125] In some embodiments, the septum 65 can be disposed at various locations within the distal end of the delivery device 146. For example, Figures 9A-9B As shown, the diaphragm 65 can be disposed proximal to the coupling location of the extension tube 40 and / or distal to the distal end of the slot 56. For example, as shown in FIG. Figures 10A-10B As shown, the diaphragm 65 can be disposed at the distal end of the housing 50 or can be disposed within a connector coupled to the housing 50. In some embodiments, the diaphragm 65 can be disposed within the seat 115, for example, as Fig. 10C As shown. Fig. 10C As shown, in some embodiments, the extension tube 40 can extend proximally from the seat 115 and / or extend through the proximal end of the housing 50 .

[0126] All examples and conditional language recorded herein are intended to be used for teaching purposes, to help the reader understand the present invention and the inventor to further develop the conception contributed by this area, and should be interpreted as not being limited to the examples and conditions of these specific records. Although embodiments of the present invention have been described in detail, it should be understood that various changes, replacements and variations can be made to it without departing from the spirit and scope of the present invention. It should be understood that any delivery device and / or one or more included parts can be combined with one or more components of one or more catheter assemblies in the catheter assembly described in the present disclosure. It should be understood that one or more components of a specific delivery device can be combined with one or more components of another specific delivery device. For example, any fluid permeable structure described about a specific delivery device can be combined with one or more components of another specific delivery device.

Claims

1. A delivery device for delivering a device through an intravenous catheter assembly, the delivery device comprising: a housing (50) having a distal end and a proximal end, wherein the distal end of the housing comprises a connector, wherein the distal end of the housing or the connector comprises a septum for preventing fluid from flowing into the distal end of the housing; and an instrument configured to be advanced distally from the housing, the instrument comprising a guidewire, wherein the instrument comprises a proximal end and a distal end, wherein the distal end of the instrument comprises a fluid permeable structure, the fluid permeable structure comprising an elongated core and a coil extending around and coupled to the elongated core, wherein the fluid permeable structure is configured to extend beyond a distal end of a catheter (24) of an intravenous catheter assembly; wherein the device further comprises a conduit (102, 110), the guide wire being disposed within the conduit, the conduit comprising a proximal end, a distal end, and another connector (116) disposed at the proximal end of the conduit, the proximal end of the conduit being disposed at the proximal end of the housing, wherein the distal end of the conduit comprises the fluid permeable structure, and The coil comprises a distal end and a proximal end, wherein the distal end of the coil is disposed distal to the distal end of the elongated core.

2. The delivery device according to claim 1, wherein: The housing comprises a slot, wherein the delivery device further comprises: A guidewire seat is disposed within the housing, wherein the guidewire is fixed to the guidewire seat, wherein the guidewire seat is configured to move along the slot to advance the guidewire in a distal direction distal to the distal end of the housing.

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

4. The delivery device according to claim 1, wherein: The coils are secured to the elongated core at a plurality of locations along the length of the elongated core.

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

6. The delivery device of claim 1, wherein: The spacing between the loops of the coil varies.

7. The delivery device of claim 1, wherein: The elongated core includes a first portion having a first outer diameter and a second portion having a second outer diameter.

8. The delivery device of claim 1, wherein: The distal end of the coil is open.

9. The delivery device of claim 1, wherein: The distal end of the coil is closed.

10. The delivery device of claim 1, wherein: The other connector (116) is configured to be coupled to the retainer (46).

11. A catheter system, comprising: The delivery device according to any one of claims 1 to 10; and a catheter assembly coupled to the delivery device, the catheter assembly comprising: a catheter adapter comprising a distal end, a proximal end, a lumen extending between the distal and proximal ends of the catheter adapter; and a catheter secured to the catheter adapter and extending distally from the catheter adapter, wherein the catheter includes a distal end and a proximal end, Wherein, the distal end of the instrument is configured to be disposed distally of the distal end of the catheter.

12. The catheter system of claim 11, wherein the blood sampling passage of the catheter system does not extend through the housing of the delivery device.

13. The catheter system of claim 11, wherein: The fluid permeable structure of the conduit (102) includes grooves, flat areas, a plurality of side holes, or a plurality of channels extending parallel to the longitudinal axis of the elongated core.

14. The catheter system of claim 11, wherein: The elongated core includes a distal end and a proximal end, wherein the distal end of the coil and the distal end of the elongated core are configured to be disposed distally of the distal end of the catheter.

15. The catheter system of claim 11, further comprising a gap between an outer diameter of the instrument and an inner diameter of the catheter.

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