Sheath

• US 10,507,305 B2
• Filed: 01/27/2017
• Issued: 12/17/2019
• Est. Priority Date: 12/15/2009
• Status: Active Grant

• Current Assignee: Board of Regents of the University of Nebraska
• Original Assignee: Board of Regents of the University of Nebraska
• Inventors: Gordon, Gregory
• Primary Examiner(s): Marcetich, Adam
• Application Number:
  US15/417,395
• Publication Number:
  US 20170136218A1
• Time in Patent Office: 1,054 Days
• CPC Class Codes: A61B 17/34 Trocars; Puncturing needles pointed biopsy instruments A61B10/0233; devices for piercing the ear-lobes A44C7/001; seals or hemostasis valves A61M39/06
• CPC Class Codes: A61B 17/3462 with means for changing the diameter or the orientation of the entrance port of the cannula, e.g. for use with different-sized instruments, reduction ports, adapter seals expandable cannulas A61B17/3417
• CPC Class Codes: A61B 17/3478 Endoscopic needles, e.g. for infusion biopsy needles A61B10/0233; catheters with injection needles A61M25/0067
• CPC Class Codes: A61B 17/3498 Valves therefor, e.g. flapper valves, slide valves haemostasis valves A61M39/06; check valves A61M39/24
• CPC Class Codes: A61B 2017/3419 Sealing means between cannula and body
• CPC Class Codes: A61M 1/3655 Arterio-venous shunts or fistulae
• CPC Class Codes: A61M 1/3661 for haemodialysis
• CPC Class Codes: A61M 2025/028 having a mainly rigid support structure
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2039/0009 Assemblies therefor designed for particular applications, e.g. contrast or saline injection, suction or irrigation
• CPC Class Codes: A61M 25/0097 characterised by the hub connectors A61M39/10
• CPC Class Codes: A61M 25/01 Introducing, guiding, advancing, emplacing or holding catheters A61M25/10 takes precedence
• CPC Class Codes: A61M 25/02 Holding devices, e.g. on the body
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/08 Tubes; Storage means specially adapted therefor

Abstract

The present application includes a sheath that is suitable for use in a variety of medical procedures. In one or more implementations, the sheath includes a shunt member, and a curvable portion. The curvable portion may be configured in various orientations to facilitate an intervention, such as a hemodialysis intervention, or the like, by an operator. The curvable portion may be configured to bend between a substantially straight configuration and a curved configuration. In implementations, the sheath may be configured to have detachable and/or interchangeable components (e.g., shunt member, curvable portion, etc.).

Claims

1. A system configured to receive an interventional tool, the system comprising:

a shunt member portion positionable through a perforation in a side wall of an anatomical vessel of a patient, the shunt member portion including;

a distal opening configured to reside in the anatomical vessel, and

a member that resides external to the anatomical vessel and external to the patient;

a sheath tube portion mated to the external member of the shunt member portion, the sheath tube portion including;

a proximal end opposite from the shunt member portion, and

a tube wall retainable in a curved configuration in which a proximal portion of the sheath tube portion is transverse to the shunt member portion, the proximal end of the sheath tube portion configured to receive the interventional tool; and

a location of increased thickness that prevents migration of the sheath tube portion into the patient, the location of increased thickness located between a portion of the shunt member portion residing internal to the patient and the sheath tube portion;

wherein an internal access path defined through the sheath tube portion, the shunt member portion, and the anatomical vessel is configured to movably receive an interventional tool while the sheath tube portion resides entirely external to the patient and the shunt member portion resides partially internal to the patient and partially external to the patient; and

a clasp device configured to retain the sheath tube portion in the curved configuration.

2. The system of claim 1, comprising a septum hub located at the proximal end of the sheath tube portion, the septum hub configured to receive the interventional tool.

3. The system of claim 2, wherein the septum hub comprises an introducer portion at a proximal end of the septum hub and a secondary tube for injecting or suctioning fluids.

4. The system of claim 1, wherein the sheath tube portion is kink resistant.

5. The system of claim 4, wherein in the curved configuration the tube wall can form a 180°

curve without kinking.

6. The system of claim 1, wherein the sheath tube portion retains the curved configuration when curved by a user.

7. The system of claim 1, comprising a stabilization device configured to retain the sheath tube portion in a fixed position relative to the perforation in a side wall of an anatomical vessel when the interventional tool is movably received.

8. The system of claim 7, wherein the stabilization device comprises an adhesive patch.

9. The system of claim 7, wherein the stabilization device comprises a strap.

10. The system of claim 1, wherein the sheath tube portion is detachably mated to the external member of the shunt member portion.

11. The system of claim 1, wherein the sheath tube portion has a distal end, and the distal end is detachably mated to the external member of the shunt member.

12. The system of claim 11, wherein the sheath tube portion has a longitudinal length extending between a distal end of the sheath tube portion and the proximal end of the sheath tube portion that is greater than the maximum longitudinal length of the shunt member portion.

13. The system of claim 12, wherein the shunt member portion includes a connection member configured to detachably mate with the sheath tube portion.

14. The system of claim 1, wherein the sheath tube portion has a longitudinal length sufficient to maintain a user outside of a radiation field when using the radiation field on a patient for visualizing vascular structures.

15. A system configured to receive an interventional tool, the system comprising:

a shunt member portion positionable through a perforation in a side wall of an anatomical vessel of a patient, the shunt member portion including;

a distal opening configured to reside in the anatomical vessel, and

a member that resides external to the anatomical vessel and external to the patient;

a sheath tube portion mated to the external member of the shunt member portion, the sheath tube portion including;

a proximal end opposite from the shunt member portion, and

a tube wall retainable in a curved configuration in which a proximal portion of the sheath tube portion is transverse to the shunt member portion, the proximal end of the sheath tube portion configured to receive the interventional tool;

a location of increased thickness that prevents migration of the sheath tube portion into the patient, the location of increased thickness located between a portion of the shunt member portion residing internal to the patient and the sheath tube portion; and

a stabilization device configured to retain the sheath tube portion in the curved configuration relative to the perforation in a side wall of an anatomical vessel when the interventional tool is movably received;

wherein an internal access path defined through the sheath tube portion, the shunt member portion, and the anatomical vessel is configured to movably receive an interventional tool while the sheath tube portion resides entirely external to the patient and the shunt member portion resides partially internal to the patient and partially external to the patient.

16. The system of claim 15, wherein the sheath tube portion is detachably mated to the external member of the shunt member portion.

17. The system of claim 16, wherein the sheath tube portion is configured to bend between a curved configuration and a substantially straight configuration.

18. The system of claim 17, wherein in the curved configuration the sheath tube portion can form a 180°

curve without kinking.

19. The system of claim 15, the stabilization device couplable to the sheath tube portion proximate a distal end of the sheath tube portion.

20. The system of claim 15, wherein the stabilization device is further couplable to the sheath tube portion proximate a proximal end of the sheath tube device such that the stabilization device is coupleable at a first position proximate the proximal end of the sheath tube portion and at a second position proximate a distal end of the sheath tube portion to retain the sheath tube portion in the curved configuration while the interventional tool is movably received within the internal access path.

21. A system configured to receive an interventional tool, the system comprising:

a shunt member portion positionable through a perforation in a side wall of an anatomical vessel, the shunt member portion including;

a distal opening configured to reside in the anatomical vessel, and

a member that resides external to the anatomical vessel; and

a sheath tube portion mated to the external member of the shunt member portion, the sheath tube portion including;

a proximal end opposite from the shunt member portion, and

a tube wall retainable in a curved configuration in which a proximal portion of the sheath tube portion is transverse to the shunt member portion, the proximal end of the sheath tube portion configured to receive the interventional tool;

wherein an internal access path defined through the sheath tube portion, the shunt member portion, and the anatomical vessel is configured to movably receive an interventional tool; and

comprising a clasp device configured to retain the sheath tube portion in the curved configuration.

22. The system of claim 21, wherein the clasp device is coupleable at a first position proximate the proximal end of the sheath tube portion and at a second position proximate a distal end of the sheath tube portion to retain the sheath tube portion in the curved configuration while the interventional tool is movably received within the internal access path.

23. The system of claim 21, wherein the clasp is configured to be received in a notch such that the sheath tube portion is maintained in the curved configuration while the interventional tool is movably received within the internal access path.

24. The system of claim 21, comprising a dilator engaged with the shunt member portion, wherein an internal access path defined through the sheath tube portion, the shunt member portion, and the anatomical vessel is configured to movably receive an interventional tool while the sheath tube portion resides entirely external to the patient, the shunt member portion resides partially internal to the patient and partially external to the patient, and the dilator has been removed from engagement with the shunt member portion.