WO2025235259A1

WO2025235259A1 - Catheter system for subcutaneous fluid infusion

Info

Publication number: WO2025235259A1
Application number: PCT/US2025/026899
Authority: WO
Inventors: Jonathan Karl Burkholz
Original assignee: Becton Dickinson and Co
Current assignee: Becton Dickinson and Co
Priority date: 2024-05-07
Filing date: 2025-04-29
Publication date: 2025-11-13
Anticipated expiration: 2026-11-07

Abstract

A catheter system (30) for subcutaneous infusion of fluid may include a catheter (32), which may include one or more fenestrations (72) disposed between a distal end (34) of the catheter and a proximal (36) end of the catheter. The catheter system may include an introducer needle (48) extending through the catheter. The catheter system may include a catheter adapter (38), which may include a stabilization platform (44) having an upper surface that is generally planar. The catheter system may include an adapter (62), which may include one or more ports (63), and an extension tube (64). The extension tube may be coupled to the catheter adapter and the adapter.

Description

CATHETER SYSTEM FOR SUBCUTANEOUS FLUID INFUSION

BACKGROUND

[0001] A common type of catheter assembly includes a peripheral intravenous catheter (“PIVC”) that is over-the-needle. As its name implies, the PIVC that is over-the-needle may be mounted over an introducer needle having a sharp distal tip. The catheter assembly may include a catheter adapter, the PIVC extending distally from the catheter adapter, and the introducer needle extending through the PIVC. The PIVC and the introducer needle may be assembled such that the distal tip of the introducer needle extends beyond the distal tip of the PIVC with the bevel of the introducer needle facing up away from skin of the patient immediately prior to insertion into the skin. The PIVC and the introducer needle are generally inserted at a shallow angle through the skin into a vein of the patient.

[0002] In order to verify proper placement of the introducer needle and/or the PIVC in the blood vessel, a clinician may confirm that there is flashback of blood in a flashback chamber of the catheter assembly or in a space between the introducer needle and the PIVC. Once placement of the introducer needle has been confirmed, the clinician may remove the introducer needle, leaving the PIVC in place in the vein for future blood withdrawal or fluid infusion.

[0003] In some clinical situations, subcutaneous infusion of fluids provides advantages over intravenous fluid infusion. Subcutaneous infusion is often suited for patients with dehydration and/or when vascular access is difficult to obtain. Further advantages of subcutaneous infusion may include ease of placement, low cost, and a reduced risk of serious complications such as infection, including catheter blood stream infection. [0004] 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 only provided to illustrate one example technology area where some implementations described herein may be practiced.

SUMMARY

[0005] The present disclosure relates generally to vascular access devices, systems, and methods. In particular, the present disclosure relates to a catheter system and methods for subcutaneous fluid infusion.

[0006] In some embodiments, a catheter system for subcutaneous infusion of fluid may include a catheter, which may include a distal end, a proximal end, and one or more fenestrations disposed between the distal end of the catheter and the proximal end of the catheter. In some embodiments, the catheter system may include an introducer needle extending through the catheter.

[0007] In some embodiments, the catheter system may include a catheter adapter, which may include a distal end, a proximal end, and a stabilization platform. In some embodiments, an upper surface of the stabilization platform may be planar or generally planar such that the stabilization platform is low-profile. In some embodiments, the catheter may extend distally from the distal end of the catheter adapter.

[0008] In some embodiments, the catheter system may include an adapter, which may include one or more ports. In some embodiments, the catheter system may include an extension tube, which may include a distal end and a proximal end. In some embodiments, the distal end of the extension tube may be coupled to the proximal end of the catheter adapter. In some embodiments, the proximal end of the extension tube may be coupled to the adapter. In some embodiments, the distal end of the extension tube may be integrated with the proximal end of the catheter adapter.

[0009] In some embodiments, the catheter system may include a needleless access connector coupled to the port. In some embodiments, the port may include a first port, and the adapter may include a second port. In some embodiments, the adapter may not be coupled to a vent plug.

[0010] In some embodiments, the introducer needle may include a sharp distal tip. In some embodiments, the introducer needle may not include a blood flashback notch. In some embodiments, the extension tube may not be coupled to a clamp.

[0011] In some embodiments, the catheter may be 20G or 18G, and a length of the catheter may be 1.25 inches to 1.75 inches, inclusive. In some embodiments, the catheter may be 24G or 22G, and a length of the catheter may be greater than 0.75 inches and less than or equal to 1.0 inch. In some embodiments, the catheter may be 26G, and a length of the catheter may be 0.5 inches to 1.0 inches, inclusive. In some embodiments, a gauge and/or length of the catheter may vary.

[0012] In some embodiments, a method for subcutaneous infusion of fluid may include prepriming the catheter system with saline solution. In some embodiments, after pre-priming the catheter system with saline solution, the method may include placing the distal end of the catheter subcutaneously and infusing fluid subcutaneously through the catheter system.

[0013] It is to be understood that both the foregoing general description and the following detailed description are examples and explanatory and are not restrictive of the invention, as claimed. It should be understood that the various embodiments are not limited to the arrangements and instrumentality illustrated in the drawings. It should also be understood that the embodiments may be combined, or that other embodiments may be utilized and that structural changes, unless so claimed, may be made without departing from the scope of the various embodiments of the present disclosure. The following detailed description is, therefore, not to be taken in a limiting sense.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

[0014] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

[0015] Figure 1 is an upper perspective view of a prior art catheter system;

[0016] Figure 2A is an upper perspective view of an example catheter system for subcutaneous infusion of a fluid, according to some embodiments;

[0017] Figure 2B is a cross-sectional view of the catheter system, according to some embodiments;

[0018] Figure 3A is an upper perspective view of an example distal end of the catheter system, according to some embodiments;

[0019] Figure 3B is an upper perspective view of another example distal end of the catheter system, according to some embodiments; and

[0020] Figure 3C is an upper perspective view of an example catheter of the catheter system, according to some embodiments.

DESCRIPTION OF EMBODIMENTS

[0021] The present disclosure relates generally to vascular access devices, systems, and methods. In particular, the present disclosure relates to a catheter system and methods for subcutaneous fluid infusion. Referring now to Figure 1, a prior art catheter system 10 may include the BD SAF-T-INTIMA™ Safety System available from Becton, Dickinson & Company of Franklin Lakes, New Jersey. The prior art catheter system 10 is used for blood collection and/or infusion into a blood vessel of a patient. The prior art catheter system 10 provides several advantages such as having a catheter adapter 12 with a low-profde stabilization platform 14 to facilitate taping or adhering the catheter adapter 12 to skin of the patient. The prior art catheter system 10 also includes an integrated extension set 16 with a Y-adapter 18, which may facilitate blood collection and/or flushing. A catheter 20 extends distally from the catheter adapter 12. A needle assembly 22, including an introducer needle 24 extending through the catheter 20, is used to insert the catheter 20 into the blood vessel of the patient.

[0022] The prior art catheter system 10 includes a clamp 26 on the integrated extension set 16 and a vent plug 28 coupled to the Y-adapter 18. After the prior art catheter system 10 is inserted into the blood vessel of the patient and the introducer needle 24 is removed from the catheter 20, the clamp 26 is engaged and the vent plug 28 is removed. The clamp 26 is then released from the integrated extension set 16 and the catheter 20 is flushed prior to starting infusion into the blood vessel.

[0023] Referring now to Figures 2A-2B, in some embodiments, a catheter system 30 may be similar or identical to the prior art catheter system 10 in terms of one or more components and/or operation. In some embodiments, the catheter system 30 may include one or more features to adapt and improve the prior art catheter system 10 for subcutaneous fluid infusion.

[0024] In some embodiments, given the catheter system 30 is inserted into subcutaneous tissue of the patient, there is a preference for smaller gauge sized catheters to reduce insertion pain for the patient. In some embodiments, the one or more features of the catheter system 30 improve performance on smaller catheters to support a larger range of potential fluid delivery and absorption rates. In some embodiments, the one or more features may include one or more of the following: one or more fenestrations on a catheter, an introducer needle without a blood flashback notch, longer catheter length options, and one or more pre-attached needleless access connectors. [0025] In some embodiments, the one or more features support maintaining adequate flow rate and absorption uptake while reducing a size of the introducer needle and catheter to reduce patient discomfort and provide cost benefits and workflow efficiency. In some embodiments, the one or more features of the catheter system 30 increase a range of potential fluid delivery dates for a given catheter gauge size while maintaining benefits of the prior art catheter system 10 such as a low- profile stabilization platform and an integrated extension set. In some embodiments, the one or more features of the catheter system 30 may also reduce a gauge size of the catheter for a given fluid delivery rate, which may reduce patient discomfort.

[0026] In some embodiments, the catheter system 30 for subcutaneous infusion of fluid may include a catheter 32, which may include a distal end 34 and a proximal end 36. In some embodiments, the catheter system 30 may include a catheter adapter 38, which may include a distal end 40, a proximal end 42, and a stabilization platform 44. In some embodiments, the stabilization platform 44 may be low-profile to facilitate taping or adhering the catheter adapter 38 to the skin of the patient. In some embodiments, an upper surface of the stabilization platform 44 may be planar or generally planar to facilitate the stabilization platform 44 being low-profile. In some embodiments, the upper surface and/or a lower surface of the stabilization platform 44 opposite the upper surface and closest to the skin of the patient may be planar or generally planar to facilitate the stabilization platform 44 being low-profile.

[0027] In some embodiments, the catheter 32 may extend distally from the distal end 40 of the catheter adapter 38. In some embodiments, the catheter system 30 may include a needle assembly 46, which may include an introducer needle 48 extending through the catheter 32 in an insertion configuration ready for insertion into the patient. In some embodiments, the introducer needle 48 may include a sharp distal tip that may be used to insert the catheter 20 through skin of the patient and into the subcutaneous tissue such that the distal end 34 of the catheter 32 is positioned within the subcutaneous tissue for infusion therethrough.

[0028] In some embodiments, the needle assembly 46 may include a safety housing 50, which may include two or more telescoping members. In some embodiments, the telescoping members may include an inner telescoping member 52 and an outer telescoping member 54. In some embodiments, when the catheter system 30 is in the insertion configuration ready for insertion into a patient, as illustrated, for example, in Figures 2A-2B, the safety housing 50 may be collapsed. In some embodiments, a proximal end of the introducer needle 48 may be coupled to an outer grip 56. In some embodiments, the outer grip 56 housing the telescoping members in the insertion configuration may be proximally retracted to withdraw the introducer needle 48 until a feature 58 of the introducer needle 48 contacts an inner surface of the inner telescoping member 52 having a smaller diameter than the feature of the introducer needle 48. In some embodiments, the outer grip 56 may be further retracted to expand the safety housing 50 and passively encase the introducer needle 48 within the expanded safety housing 50.

[0029] In some embodiments, a lumen of the introducer needle 48 may extend from a distal opening 60 of the introducer needle 48 at the sharp distal tip in a proximal direction. In some embodiments, the introducer needle 48 may not include a blood flashback notch, which may not be needed for subcutaneous infusion. In these embodiments, a wall of the introducer needle 48 forming the lumen may be closed from the sharp distal tip to the proximal end of the introducer needle 48. In some embodiments, the blood flashback notch may not be needed because the catheter system 30 is typically pre-primed with saline solution to remove air from the catheter system 30 and ensure air does not enter a bloodstream of the patient. Moreover, in some embodiments, the blood flashback notch is not needed for subcutaneous placement, and an inner diameter of the catheter 32 at the distal end 34 may be increased for a given catheter outer diameter because a gap between an outer surface of the introducer needle and an inner surface of the catheter 32 forming a lumen is not needed for blood flashback. In some embodiments, the inner diameter of the catheter 32 that is increased may provide additional flow rate benefits for a given catheter gauge. In some embodiments, the blood flashback notch may be disposed within the introducer needle 48 to provide a visual indication that the catheter 32 is inserted within a blood vessel instead of subcutaneously.

[0030] In some embodiments, the catheter system 30 may include an adapter 62, which may include one or more ports 63. In some embodiments, the catheter system 30 may include an extension tube 64, which may include a distal end 66 and a proximal end 68. In some embodiments, the distal end 66 of the extension tube 64 may be coupled to or integrated with the proximal end 36 of the catheter adapter 38. In some embodiments, the proximal end 68 of the extension tube 64 may be coupled to the adapter 62. In some embodiments, the distal end 66 of the extension tube 64 may be integrated with the proximal end 68 of the catheter adapter 38. In some embodiments, the extension tube 64 and the adapter 62 may facilitate infusion at a distance from an insertion site of the catheter system, which may decrease a risk of disturbing the catheter 34 at the insertion site. [0031] In some embodiments, the catheter system 30 may include a needleless access connector 70 coupled to a particular one of the ports 63 that may be angled with respect to a longitudinal axis of the catheter system 30. As an example, the needleless access connector 70 may include the MAXPLUS™ and MAXZERO™ Needle-free Connector available from Becton Dickinson and Company of Franklin Lakes, New lersey. In some embodiments, the needleless access connector 70 may be pre-attached to the particular one of the ports 63, and the adapter 62 may not be coupled to a vent plug which may not be needed because the catheter system 30 is typically pre-primed with saline solution to remove air from the catheter system 30. In some embodiments, a vent plug, such as, for example, the vent plug 28 of Figure 1, may be coupled to the adapter 62 in case visualization of blood flashback is desired to indicate placement of the catheter 32 within a blood vessel instead of subcutaneously.

[0032] In some embodiments, the extension tube 64 may not be coupled to a clamp. In these embodiments, the clamp may be eliminated because blood exposure risk is low due to subcutaneous rather than vascular placement. In some embodiments, the clamp, such as, for example, the clamp 26 of Figure 1, may be used on the extension tube 64 to further reduce the low risk of blood exposure during subcutaneous placement of the catheter 32.

[0033] Referring back to Figure 1, the prior art catheter system 10, illustrated in Figure 1, includes the catheter 20 having a length of 0.75 inches for 24G and 22G configurations, and 1.0 inches for 20 G and 18 G configurations. Referring again to Figures 2A-2B, in some embodiments, the catheter may be 20G or 18G, and a length of the catheter 32 may be 1.25 inches to 1.75 inches, inclusive. In some embodiments, the catheter 32 may be 24G or 22G, and a length of the catheter 32 may be greater than 0.75 inches and less than or equal to 1.0 inch. In some embodiments, the catheter 32 may be 26G, and a length of the catheter 32 may be 0.5 inches to 1.0 inches, inclusive. Thus, in some embodiments, a length of the catheter 32 may be increased compared to the prior art to allow additional axial spacing between the distal end 34 and the fenestrations 72. In some embodiments, because the catheter 32 includes the fenestrations 72, a 26G size catheter may also be viable to provide sufficient flow rates during subcutaneous infusion, further reducing a size of the introducer needle 48 and reducing discomfort to the patient. [0034] In some embodiments, a method for subcutaneous infusion of fluid may include prepriming the catheter system 30 with saline solution. In some embodiments, after pre-priming the catheter system 30 with saline solution, the method may include placing the distal end 34 of the catheter 32 in subcutaneous tissue and infusing fluid subcutaneously through the catheter system 30.

[0035] In some embodiments, one or more of the following may be included in a kit: the catheter system 30, a site disinfection device (e.g. an alcohol pad or CHLORAPREP™ skin preparation), a stabilization device, a securement dressing, an extension set, an additional needleless connector to replace a pre-attached needleless connector of the catheter system 30, a skin adhesive for securement, tape, an identification label, and a disinfection cap.

[0036] Referring now to Figures 3A-3C, in some embodiments, the catheter system 30 may include one or more fenestrations 72 disposed between the distal end 34 of the catheter 32 and the proximal end 36 of the catheter 32. In some embodiments, the fenestrations 72 may be disposed on a tapered distal tip of the catheter 32. Additionally or alternatively, the fenestrations 72 may be disposed along a length of the catheter 32 proximal to the tapered distal tip. In some embodiments, a distribution or placement of the fenestrations 72 along the length of the catheter 32 may include a variety of patterns to facilitate subcutaneous delivery and promote efficient absorption. In some embodiments, shapes of the fenestrations 72 may also include a variety of geometries to facilitate subcutaneous delivery and promote efficient absorption. As an example, the shapes of the fenestrations 72 may be oval.

[0037] Figures 3B-3C illustrate the catheter 32 with the introducer needle 48 removed and a fenestration distribution to provide fluid delivery at the distal end 34 of the catheter 32 and at additional locations proximal to the distal end 34 to allow more efficient absorption of the fluid being delivered. In some embodiments, although the fenestrations 72 may add cost to manufacturing the catheter system 30, this may be offset by elimination of one or more of the blood flashback notch, the vent plug, and having the needleless connector on the adapter.

[0038] All examples and conditional language recited herein are intended for pedagogical objects to aid the reader in understanding the present disclosure and the concepts contributed by the inventor to furthering the art and are to be construed as being without limitation to such specifically recited examples and conditions. Although embodiments of the present inventions have been described in detail, it should be understood that the various changes, substitutions, and alterations could be made hereto without departing from the spirit and scope of the present disclosure.

Claims

CLAIMS What is claimed:

1. A catheter system for subcutaneous infusion of fluid, comprising: a catheter, comprising a distal end, a proximal end, and a fenestration disposed between the distal end of the catheter and the proximal end of the catheter; an introducer needle extending through the catheter; a catheter adapter, comprising a distal end, a proximal end, and a stabilization platform, wherein an upper surface of the stabilization platform is generally planar, wherein the catheter extends distally from the distal end of the catheter adapter; an adapter comprising a port; and an extension tube, comprising a distal end and a proximal end, wherein the distal end of the extension tube is coupled to the proximal end of the catheter adapter, wherein the proximal end of the extension tube is coupled to the adapter.

2. The catheter system of claim 1, wherein the distal end of the extension tube is integrated with the proximal end of the catheter adapter.

3. The catheter system of claim 1, further comprising a needleless access connector coupled to the port.

4. The catheter system of claim 1, wherein the port is a first port, wherein the adapter comprises a second port.

5. The catheter system of claim 1 , wherein the adapter is not coupled to a vent plug.

6. The catheter system of claim 1, wherein the introducer needle comprises a sharp distal tip, wherein the introducer needle does not include a blood flashback notch.

7. The catheter system of claim 1, wherein the extension tube is not coupled to a clamp.

8. The catheter system of claim 1, wherein the catheter comprises a fenestration disposed between the distal end of the catheter and the proximal end of the catheter.

9. The catheter system of claim 1, wherein the catheter is 20G or 18G, wherein a length of the catheter is 1.25 inches to 1.75 inches, inclusive.

10. The catheter system of claim 1, wherein the catheter is 24G or 22G, wherein a length of the catheter is greater than 0.75 inches and less than or equal to 1.0 inch.

11. The catheter system of claim 1 , wherein the catheter is 26G, wherein a length of the catheter is 0.5 inches to 1.0 inches, inclusive.

12. A method for subcutaneous infusion of fluid, comprising: pre-priming a catheter system with saline solution, wherein the catheter system comprises: a catheter, comprising a distal end, a proximal end, and a fenestration disposed between the distal end of the catheter and the proximal end of the catheter; an introducer needle extending through the catheter; a catheter adapter, comprising a distal end, a proximal end, and a stabilization platform, wherein an upper surface of the stabilization platform is generally planar, wherein the catheter extends distally from the distal end of the catheter adapter; an adapter comprising a port; and an extension tube, comprising a distal end and a proximal end, wherein the distal end of the extension tube is coupled to the proximal end of the catheter adapter, wherein the proximal end of the extension tube is coupled to the adapter.

13. The method of claim 12, further comprising after pre-priming the catheter system with saline solution, placing the distal end of the catheter subcutaneously and infusing fluid subcutaneously through the catheter system.

14. The method of claim 12, wherein the distal end of the extension tube is integrated with the proximal end of the catheter adapter.

15. The method of claim 12, further comprising a needleless access connector coupled to the port.

16. The method of claim 12, wherein the introducer needle comprises a sharp distal tip, wherein the introducer needle does not include a blood flashback notch.

17. The method of claim 12, wherein the catheter is 20G or 18G, wherein a length of the catheter is 1.25 inches to 1.75 inches, inclusive.

18. The method of claim 12, wherein the catheter is 24G or 22G, wherein a length of the catheter is greater than 0.75 inches and less than or equal to 1.0 inch.

19. The method of claim 12, wherein the catheter is 26G, wherein a length of the catheter is

0.5 inches to 1.0 inches, inclusive.