CATHETER DEVICE HAVING BENDABLE EXTENSION LEGS - Patent application

Abstract

The catheter device can have bendable extension legs. The extension legs can be designed to include armature wires that allow the extension legs to bend and hold a variety of orientations, so that the clinician can easily position the luers of the extension legs in a position appropriate for a particular patient and / or clinician.

Description

[Technical field]

[0001] SUMMARY The present disclosure relates generally to a catheter device having bendable extension legs. [Background technology]

[0002] Peripherally inserted central catheters (PICC) and dialysis catheters (commonly "catheter devices") typically have multiple lumens. These lumens are typically separated into separate "extension legs" at the proximal end of the catheter device. These catheter devices are often placed on or near the patient's neck, face, or chin area. If the extension legs are flexible, they may cause patient discomfort or the luers at the ends of the extension legs may reach locations that may be cumbersome for the clinician to access.

[0003] FIG. 1A provides an example of a catheter device 100a including flexible extension legs. The catheter device 100a includes a catheter 101, a hub 102 from which the catheter extends distally, two extension legs 103 extending proximally from the hub 102, a luer 104 at the proximal end of the extension legs 103, a clamp 105 on each extension leg 103, and a fixation platform 106 to facilitate fixation of the catheter device 100a to the skin of a patient. Each extension leg 103 forms a lumen that extends from the respective luer 104 through the distal end of the catheter 101. Because the extension legs 103 of the catheter device 100a are flexible, they are susceptible to the above problems.

[0004] To address such issues with flexible extension legs, some catheter devices include preformed rigid extension legs. In this context, "rigid" refers to the fact that the extension legs are configured to retain their shape. By preforming the rigid extension legs, the luers can be held in a fixed relative position to minimize patient discomfort and / or facilitate clinician access.

[0005] 1B provides an example of a catheter device 100b that includes extension legs 103 that are pre-formed to curve downward to position luers 104 on opposing sides of the hub 102. The extension legs 103 of the catheter device 100b may be formed of a relatively rigid material that allows them to retain this general shape. In other words, the extension legs 103 of the catheter device 100b are not configured to be repositioned from their pre-formed curved orientation.

[0006] Preformed, rigid extension legs present various problems. For example, the extension legs 103 may be purposefully designed to move the luer 104 away from the patient's neck, face, or chin. However, every patient is different, so a one-size-fits-all approach is insufficient. Also, preforming the extension legs requires complex machinery and additional manufacturing steps.

[0007] The subject matter claimed herein is not limited to embodiments that solve any shortcomings or that operate only in such environments. Rather, this background is only provided to illustrate one example technology area where some implementations described herein may be practiced. Summary of the Invention

[0008] The extension legs may be designed to include armature wires that allow the extension legs to bend and hold a variety of orientations, allowing the clinician to easily position the luers of the extension legs in a position appropriate for a particular patient and / or clinician.

[0009] In some embodiments of the present disclosure, a catheter device may include a catheter, a hub from which the catheter extends distally, and one or more extension legs extending proximally from the hub, each of the one or more extension legs including an armature wire.

[0010] In some embodiments, the one or more extension legs may include two or more extension legs.

[0011] In some embodiments, each of the one or more extension legs may include a first length of tubing and a second length of tubing. The armature wire may be included in the second length of tubing.

[0012] In some embodiments, the second length of tubing may be connected to the first length of tubing by a length of connecting material.

[0013] In some embodiments, the second length of tubing may be shorter than the first length of tubing.

[0014] In some embodiments, the distal end of the second length of tubing can be spaced from the hub and the proximal end of the second length of tubing can be spaced from a luer that is connected to the proximal end of the first length of tubing.

[0015] In some embodiments, the first length of tubing and the second length of tubing may be extruded together.

[0016] In some embodiments, each of the one or more extension legs may include a length of tubing including a first lumen and a second lumen. The armature wire may be contained in the second lumen.

[0017] In some embodiments, the first lumen can have a crescent cross-sectional shape.

[0018] In some embodiments, the crescent cross-sectional shape of the first lumen may extend partially around the second lumen.

[0019] In some embodiments, a septum extends between and separates the first and second lumens.

[0020] In some embodiments of the present disclosure, a catheter device may include a catheter, a hub from which the catheter extends distally, and one or more extension legs extending proximally from the hub. Each of the one or more extension legs includes a first lumen and a second lumen. The second lumen is configured to maintain an orientation of the extension leg.

[0021] In some embodiments, each of the one or more extension legs can include an armature wire extending into the second lumen. The armature wire can maintain the orientation of the extension legs.

[0022] In some embodiments, a first lumen may be formed in a first length of tubing and a second lumen may be formed in a second length of tubing connected to the first length of tubing.

[0023] In some embodiments, the first and second lumens may be formed within a length of tubing.

[0024] In some embodiments, each of the one or more extension legs may include a luer.

[0025] In some embodiments of the present disclosure, a method for creating an extension leg of a catheter device may include forming a first lumen and a second lumen and placing an armature wire in the second lumen.

[0026] In some embodiments, a first lumen may be formed in a first length of tubing and a second lumen may be formed in a second length of tubing connected to the first length of tubing.

[0027] In some embodiments, the first and second lumens may be formed in a length of tubing.

[0028] In some embodiments, disposing the armature wire within the second lumen may include inserting the armature wire into the second lumen.

[0029] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are not restrictive of the claimed invention. It is to be understood that the various embodiments are not limited to the arrangements and instrumentalities shown in the drawings. It is also to be understood that the embodiments may be combined or other embodiments may be utilized, and that structural changes may be made without departing from the scope of the various embodiments of the present invention, unless so claimed. Therefore, the following detailed description is not to be taken in a limiting sense. [Brief description of the drawings]

[0030] Example embodiments will be described and explained with additional specificity and detail through the use of the accompanying drawings. [Figure 1A] FIG. 1A provides an example of a prior art catheter device that includes pre-formed rigid extension legs. [Figure 1B] FIG. 1B provides an example of a prior art catheter device that includes preformed rigid extension legs. [Figure 2A] FIG. 2A provides an example of a catheter device including an extension leg configured in accordance with one or more embodiments of the present disclosure. [Figure 2B] FIG. 2B is a cross-sectional view of an extension leg of the catheter device of FIG. 2A. [Figure 3A] FIG. 3A provides an example of another catheter device including an extension leg configured in accordance with one or more embodiments of the present disclosure. [Figure 3B] FIG. 3B is a cross-sectional view of an extension leg of the catheter device of FIG. 3A. [Figure 3C] FIG. 3C is a cross-sectional view of an extension leg of the catheter device of FIG. 3A. [Figure 3D] FIG. 3D is a cross-sectional view of the extension leg of the catheter device of FIG. 3A. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] A catheter device configured in accordance with one or more embodiments of the present disclosure may be in the form of a PICC, a dialysis catheter, or another catheter device that includes an extension leg. Also, a catheter device configured in accordance with one or more embodiments of the present disclosure may include two or more extension legs, any of which may be configured to be bendable in accordance with the techniques of the present disclosure.

[0032] 2A provides an example of a catheter device 200 configured in accordance with one or more embodiments of the present disclosure. The catheter device 200 includes a catheter 201, a hub 202, extension legs 210 each having a luer 204 at its proximal end, a clamp 205 on one or both of the extension legs 210, and a fixation platform 206. FIG. 2B is a cross-sectional view of the extension leg 210.

[0033] The extension leg 210 includes a first length of tubing 211 forming a first lumen 211a. The luer 204 is connected to the first length of tubing 211. The extension leg 210 also includes a second length of tubing 212 forming a second lumen 212a. The second length of tubing 212 may extend along and be connected to a portion of the first length of tubing 211 via a length of connecting material 213 such that the cross-sectional shape of the extension leg 210 resembles FIG. 8. The first length of tubing 211, the second length of tubing 212, and the connecting material 213 may be formed of a flexible material, and in some embodiments, may be the same material. In some embodiments, the distal end 212d of the second length of tubing 212 may be spaced from the hub 202, and the proximal end 212p of the second length of tubing 212 may be spaced from the luer 204 so as not to interfere with these components.

[0034] The armature wire 214 may extend into the second lumen 212a between a distal end 212d and a proximal end 212p. In some embodiments, the distal end 212d and the proximal end 212p may be configured to hold the armature wire 214 within the second lumen 212a. For example, the distal end 212d and the proximal end 212p may be crimped, heated, or otherwise configured to prevent the armature wire 214 from extending from the second lumen 212a. In some embodiments, the armature wire 214 may be 14 gauge, although any suitable diameter may be used.

[0035] The armature wires 214 allow the second length of tube 212 to be bent and held in various orientations. Because the second length of tube 212 is connected to the first length of tube 211 via the connecting material 213, this bending of the second length of tube 212 also allows the first length of tube 211 to be bent and held in various orientations. For example, FIG. 2A depicts a use case in which a clinician bends one extension leg 210 in a curved orientation while holding the other extension leg 210 in a straight orientation. The respective armature wires 214 can hold the extension legs 210 in these orientations unless and until the clinician or patient wishes to reorient them. Notably, in these embodiments, because the armature wires 214 are contained in the second lumen 212a, the first lumen 211a can have a typical circular cross-sectional shape and size.

[0036] In some embodiments, the extension leg 210 can be formed by extruding the first length of tubing 211, the second length of tubing 212, and the connecting material 213 as a single component. The second length of tubing 212 can then be trimmed to a desired length. The armature wire 214 can then be inserted into the second lumen 212a, and the distal end 212d and proximal end 212p can be crimped, heated, or otherwise configured to maintain the armature wire 214 within the second length of tubing 212. The luer 204 can be coupled to the first length of tubing 211 either before or after the armature wire 214 is inserted into the second length of tubing 212.

[0037] Figure 3A provides another example of a catheter device 300 configured in accordance with one or more embodiments of the present disclosure. Catheter device 300 includes a catheter 301, a hub 302, extension legs 310 each having a luer 304 at its proximal end, a clamp 305 on one or both of extension legs 310, and a fixation platform 306. Figures 3B-3D are cross-sectional views of extension leg 310.

[0038] The extension leg 310 includes a single length of tubing that forms a first lumen 311 and a second lumen 312. In some embodiments, including the depicted embodiment, the first lumen 311 may have a crescent cross-sectional shape and the second lumen 312 may have a circular cross-sectional shape. In some embodiments, the crescent shape of the first lumen 311 may extend around a portion of the second lumen 312 such that a bulkhead 313 extends between the first lumen 311 and the second lumen 312 and the bulkhead 313 separates the first lumen 311 and the second lumen 312. An armature wire 314 may be inserted into the second lumen 312, allowing the extension leg 310 to bend and hold various orientations. In some embodiments, the luer 304 may be molded onto the extension leg 310 after inserting the armature wire 314 into the second lumen 312. In some embodiments, the luer 304 can include a protrusion that inserts slightly into the second lumen 312 , thereby retaining the armature wire 314 within the second lumen 312 .

[0039] FIG. 3C depicts an embodiment in which the extension leg 310 has an outer diameter of 0.177 inches (4.496 mm), which is a typical outer diameter of an extension leg, and a wall thickness of 0.0285 inches (0.724 mm), which is a typical wall thickness of an extension leg. In such an embodiment, the second lumen 312 may have a diameter of 0.069 inches (1.753 mm) and the septum 313 may have a thickness of 0.008 inches (0.203 mm), such that the cross-sectional area of ​​the first lumen 311 may be approximately 0.0075 inches2 (4.839 mm2). By comparison, a typical extension leg lumen has a diameter of approximately 0.0113 square inches (7.29 mm2). 2 )

[0040] 3D depicts an embodiment in which extension leg 310 has a larger outer diameter of 0.0195 inches (12.581 mm) and a wall thickness of 0.0260 inches (16.774 mm). In such an embodiment, second lumen 312 may have the same 0.069 inch diameter and septum 313 may have the same 0.008 inch thickness, which allows first lumen 311 to have a 0.0119 square inch (7.677 mm) thickness to support a higher fluid flow rate. 2 ) allowing the tube to have a larger cross-sectional area.

[0041] Extension legs configured to be bendable in accordance with embodiments of the present disclosure allow a clinician to position the extension legs in an optimal orientation for the patient and / or clinician. These bendable extension legs can be manufactured without the need for special machinery and with minimal additional steps.

[0042] All examples and conditional language described herein are intended for educational purposes to aid in understanding the invention and concepts provided by the inventor to advance the art, and should be construed as not being limited to the specifically recited examples and conditions. Although the embodiments of the present invention have been described in detail, it should be understood that various changes, substitutions, and alterations can be made herein without departing from the spirit and scope of the present invention.

Claims

1. 1. A catheter device comprising: A catheter; a hub from which the catheter extends distally; one or more extension legs extending proximally from the hub, each of the one or more extension legs including an armature wire; A catheter device comprising:

2. The catheter device of claim 1 , wherein the one or more extension legs comprise two or more extension legs.

3. The catheter device of claim 1 , wherein each of the one or more extension legs includes a first length of tubing and a second length of tubing, and the armature wire is included in the second length of tubing.

4. The catheter device of claim 3 , wherein the second length of tubing is connected to the first length of tubing by a length of connecting material.

5. The catheter device of claim 3 , wherein the second length of tubing is shorter than the first length of tubing.

6. 4. The catheter device of claim 3, wherein a distal end of the second length of tubing is spaced from the hub and a proximal end of the second length of tubing is spaced from a luer connected to a proximal end of the first length of tubing.

7. The catheter device of claim 3 , wherein the first length of tubing and the second length of tubing are extruded together.

8. The catheter device of claim 1 , wherein each of the one or more extension legs comprises a length of tubing including a first lumen and a second lumen, the armature wire being contained in the second lumen.

9. The catheter device of claim 8 , wherein the first lumen has a crescent cross-sectional shape.

10. The catheter device of claim 9 , wherein the crescent cross-sectional shape of the first lumen extends partially around the second lumen.

11. The catheter device of claim 10 , wherein a septum extends between and separates the first and second lumens.

12. 1. A catheter device comprising: A catheter; a hub from which the catheter extends distally; one or more extension legs extending proximally from the hub, each of the one or more extension legs including a first lumen and a second lumen, the second lumen configured to maintain an orientation of the extension leg; A catheter device comprising:

13. The catheter device of claim 12 , wherein each of the one or more extension legs includes an armature wire extending into the second lumen, the armature wire maintaining the orientation of the extension legs.

14. 13. The catheter device of claim 12, wherein the first lumen is formed in a first length of tubing and the second lumen is formed in a second length of tubing connected to the first length of tubing.

15. The catheter device of claim 12 , wherein the first and second lumens are formed within a length of tubing.

16. The catheter device of claim 12 , wherein each of the one or more extension legs includes a luer.

17. 1. A method for creating an extension leg of a catheter device, comprising: forming a first lumen and a second lumen; disposing an armature wire within the second lumen; A method comprising:

18. 20. The method of claim 17, wherein the first lumen is formed in a first length of tubing and the second lumen is formed in a second length of tubing connected to the first length of tubing.

19. The method of claim 17 , wherein the first and second lumens are formed in a length of tubing.

20. The method of claim 17 , wherein disposing the armature wire within the second lumen comprises inserting the armature wire within the second lumen.

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