Self-expanding cannula and a method for applying and positioning a self-expanding cannula

• US 8,591,538 B2
• Filed: 01/31/2007
• Issued: 11/26/2013
• Est. Priority Date: 03/30/2006
• Status: Active Grant

• Current Assignee: Thoratec LLC
• Original Assignee: Thoratec LLC
• Inventors: Gellman, Barry N.
• Primary Examiner(s): Severson, Ryan
• Assistant Examiner(s): NGUYEN, TIN DUC
• Application Number:
  US11/701,149
• Publication Number:
  US 20070233041A1
• Time in Patent Office: 2,491 Days
• Field of Search: 606/184, 606/200, 606/198, 606/194, 606/185, 606/159, 606/127, 606/108, 606/1, 623/2.38, 623/2.37, 623/2.18, 623/2.11, 623/1.46, 623/1.42, 623/1.35, 623/1.24, 623/1.22, 623/1.2, 623/1.16, 623/1.15, 623/1.12, 623/1.11, 623/1.53, 623/1.13, 623/1.18, 623/1.19, 623/1.23, 623/1.52, 604/96.01, 604/93.01, 604/9, 604/7, 604/6.16, 604/6.11, 604/6.01, 604/532, 604/523, 604/509, 604/508, 604/506, 604/43, 604/264, 604/167.06, 604/164.03, 604/164.01, 604/103.09, 604/101.05, 604104-109, 600/36, 600/18, 600/121, 600/184, 294/47, 294/46
• US Class Current: 606/194
• CPC Class Codes: A61B 17/3439 with means for changing the inner diameter of the cannula, e.g. expandable A61B17/3423, A61B17/3431 take precedence; catheters A61M25/0662
• CPC Class Codes: A61M 1/3659 Cannulae pertaining to extracorporeal circulation
• CPC Class Codes: A61M 2025/0024 Expandable catheters or sheaths
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 60/113 in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/148 in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/20 Type thereof
• CPC Class Codes: A61M 60/857 Implantable blood tubes
• CPC Class Codes: A61M 60/861 Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body
• CPC Class Codes: A61M 60/867 using position detection during deployment, e.g. for blood pumps mounted on and driven through a catheter
• CPC Class Codes: A61M 60/894 Passive valves, i.e. valves actuated by the blood

Abstract

A self-expanding cannula providing a conduit through a skin between an inside of a corpus and an outside of the corpus is disclosed. The self-expanding cannula includes a body encompassing a lumen, and has a distal-end to be positioned outside of the corpus for attachment to an extracorporeal fluid handling system and having a proximal-end to be positioned inside of the corpus, for attachment to an organ of an human or an animal. The body of the self-expanding cannula is constructed from a braided-wire, so that the self-expanding cannula is capable of expanding from a closed diameter to an opened diameter. A catheter-sheath and a catheter-sheath-assembly as well as to a method for applying and positioning a self-expanding cannula, and a catheter-sheath-assembly are disclosed.

Claims

1. A method for positioning a self-expanding cannula within a human or an animal patient having a skin, the method comprising:

positioning a proximal end of the self-expanding cannula in or adjacent a wall of the patient,

the self-expanding cannula comprising a body encompassing a lumen, wherein the body of the self-expanding cannula is capable of passively expanding said lumen from a closed diameter to an opened diameter;

positioning a distal end of the self-expanding cannula through the skin of the patient to externally communicate the lumen of the self-expanding cannula with an external environment outside of the patient; and

securing the distal end of the self-expanding cannula to an extracorporeal fluid handling system located in the external environment outside of the patient;

thereby defining an operative position of the self-expanding cannula wherein, in the operative position, the proximal end is positioned in or adjacent the wall, and the distal end protrudes through the skin to provide communication of the lumen of the self-expanding cannula with the fluid handling system located in the external environment outside of the patient.

2. The method of claim 1, wherein the organ or vessel wall of the patient comprises a wall of a heart or a blood vessel.

3. The method of claim 1, wherein the fluid handling system comprises a blood handling system.

4. The method of claim 1, wherein prior to the positioning steps, the self-expanding cannula is a part of an assembly comprising the self-expanding cannula, in the closed diameter, encased in a sheath.

5. The method of claim 4, wherein the sheath comprises a pusher device, and wherein the method further comprises removing the sheath from the self-expanding cannula by the pusher-device, such that the self-expanding cannula expands.

6. The method of claim 1, wherein the operative position further comprises an intermediate portion of the self-expanding cannula intermediate the proximal end and the distal end being disposed within a lumen of an additional vessel of the patient.

7. The method of claim 6, wherein the opened diameter of the self-expanding cannula is larger than a diameter of the lumen of the additional vessel, and wherein a rigidity of the self-expanding cannula is low enough that, in the operative position, the intermediate portion of the self-expanding cannula expands to an intermediate diameter intermediate the closed diameter and the opened diameter, wherein the intermediate diameter is substantially the same as the diameter of the lumen of the additional vessel.

8. The method of claim 1, wherein the organ or vessel wall of the patient is a wall of a heart, and wherein a rigidity of the self-expanding cannula is low enough that, in the operative position, the proximal end of the self-expanding cannula expands to an intermediate diameter intermediate the closed diameter and the opened diameter.

9. A self-expanding cannula, configured to provide a conduit through a skin between an inside of a corpus and an outside of the corpus, said self-expanding cannula comprising:

a body encompassing a lumen, wherein the body comprises braided wire, and wherein the body is configured to passively expand from a closed diameter to an opened diameter, wherein a portion of the braided wire is covered by a flexible membrane, enabling the braided wire to articulate from the closed diameter to the opened diameter, the flexible membrane sealing an interstitial space resultant between the braid openings;

a distal end of the body configured to be positioned outside of the corpus and configured for attachment to an extracorporeal fluid handling system; and

a proximal end of the body configured to be positioned inside of the corpus, configured for attachment to an organ or a vessel of the corpus, wherein the proximal end of the self-expanding cannula comprises a bare section which does not contain the flexible membrane, in order to provide a flow of a fluid through said interstitial space resultant between the braid openings of said bare section.

10. The self-expanding cannula of claim 9, further comprising the fluid handling system, configured to be attached to the distal end of the self-expanding cannula.

11. The self-expanding cannula of claim 10, wherein the fluid handling system comprises a blood handling system.

12. The self-expanding cannula of claim 9, wherein a rigidity of the self-expanding cannula is low enough that, when the self-expanding cannula is placed within a blood vessel or through a wall of a heart in the closed position and allowed to expand, the self-expanding cannula expands to an intermediate diameter intermediate the closed diameter and the opened diameter.

13. The self-expanding cannula of claim 9, wherein the flexible membrane is positioned inside of the braided wire.

14. The self-expanding cannula of claim 9, wherein the flexible membrane is positioned outside of the braided wire.

15. The self-expanding cannula of claim 9, wherein the flexible membrane is positioned inside and outside of the braided wire.

16. The self-expanding cannula of claim 9, wherein individual wires of the braided wire of the bare section are individually coated.

17. The self-expanding cannula of claim 9, further comprising a sheath configured to house the self-expanding cannula in the closed diameter of the self-expanding cannula.

18. The self-expanding cannula of claim 9, further comprising a velour portion of the self-expanding cannula, contained within a velour-like tube.

19. The self-expanding cannula of claim 9, wherein the flexible membrane comprises at least one member of the group consisting of polyurethane, vinyl, a thermoplastic rubber, a natural rubber, and a thermoset material.

20. The self-expanding cannula of claim 9, wherein the wire is braided to a loose pitch ranging from 0.5″

to 4″

.

21. The self-expanding cannula of claim 9, wherein the wire comprises at least one member of the group consisting of plastic, a composite material, and a metal.