Expandable conduit-guide and a method for applying and positioning an expandable conduit-guide

• US 8,591,539 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:
  US11/701,277
• Publication Number:
  US 20070233172A1
• Time in Patent Office: 2,491 Days
• Field of Search: 600/184, 600/463, 600/469, 600/18, 600/36, 623/2.38, 623/2.37, 623/2.18, 623/2.11, 623/1.46, 623/1.42, 623/1.35, 623/1.24, 623/1.16, 623/1.15, 623/1.13, 623/1.11, 623/1.2, 623/1.12, 623/1.53, 623/1.18, 623/1.19, 623/1.23, 623/1.52, 623/23.64, 606/200, 606/198, 606/194, 606/185, 606/159, 606/127, 606/108, 606/184, 604/9, 604/7, 604/6.16, 604/6.11, 604/532, 604/509, 604/508, 604/43, 604/167.06, 604/101.05, 604/506, 604104-109, 128/898, 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: A61B 2017/3488 Fixation to inner organ or inner body tissue
• CPC Class Codes: A61M 2039/0673 comprising means actively pressing on the device passing through the seal, e.g. inflatable seals, diaphragms, clamps
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0662 Guide tubes
• CPC Class Codes: A61M 39/06 Haemostasis valves, i.e. gaskets sealing around a needle, catheter or the like, closing on removal thereof

Abstract

An expandable conduit-guide providing a leak-tight conduit through a skin between an inside of a corpus and an outside of the corpus is disclosed. The conduit-guide includes a body encompassing a lumen extending essentially axially along a center-line, and has a distal-end to be positioned outside of the corpus, and a proximal-end to be positioned inside of the corpus. The body of the conduit-guide is constructed from a braided-wire so that the conduit-guide is capable of actively expanding from a closed diameter to an opened diameter with the placement of the medical device positioned within the lumen (110) and passively collapsing from the opened diameter to the closed diameter upon withdrawal of the medical device under a spring load of the braided-wire. A catheter-sheath and a catheter-sheath-assembly, as well as to a method for applying and positioning an expandable conduit-guide (1), catheter-sheath (8) and a catheter-sheath-assembly (800) are disclosed.

Claims

1. A combination of an expandable conduit-guide and a medical device,

the conduit-guide providing a leak-tight conduit through a skin between an inside of a corpus and an outside of the corpus, said conduit-guide including a body encompassing a lumen, and having a distal end to be positioned outside of the corpus, and having a proximal end to be positioned inside of the corpus,

the conduit-guide and the medical device being configured and dimensioned relative to one another so that the medical device can be placed in and passed through the lumen between the distal end and the proximal end of the conduit-guide,

wherein the body of the conduit-guide is constructed from a braided wire having a spring load, wherein the body of the conduit-guide is capable of actively expanding the lumen from a closed diameter to an opened diameter and passively collapsing from the opened diameter to the closed 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, wherein the flexible membrane seals an interstitial space resultant between the braid openings, wherein the proximal end of the conduit-guide includes a bare section which does not contain the flexible membrane in order to permit tissue in-growth about the braided wire to provide for anchoring the conduit-guide,

wherein the conduit-guide and the medical device are further configured and dimensioned relative to one another so that when the medical device is placed in the lumen, the lumen actively expands, and when the medical device is withdrawn from the lumen, the body of the conduit-guide passively collapses the lumen under the spring load of the braided wire.

2. The combination of claim 1, wherein the conduit-guide further comprises a velour portion configured to emerge through the skin of the corpus when the conduit-guide is positioned with the proximal end inside of the corpus and the distal end outside of the corpus, wherein the velour portion is contained within a velour-like tube.

3. The combination of claim 1, wherein a distal wire end of the conduit-guide is closed-ended by at least one member of the group consisting of:

a fold of the wire, a welded joint end, and a coating.

4. The combination of claim 1, wherein the flexible membrane comprises at least one member of the group consisting of polyurethane, vinyl, a thermoplastic rubber, a natural rubber, a thermoset material, and silicone.

5. The combination of claim 1, wherein the closed diameter is between 0.1″

and 1″

.

6. The combination of claim 1, wherein the number of wires utilized in the over-under braid ranges from 5 to 100 wire.

7. The combination of claim 1, further comprising a sheath configured and dimensioned for the conduit-guide to be inserted therein, wherein an interior diameter of the sheath does not exceed an exterior diameter of the conduit-guide when the lumen is at the closed diameter.

8. The combination of claim 7, wherein the sheath comprises a pusher for removal of the conduit-guide after positioning the conduit-guide within the corpus.

9. The combination of claim 1, wherein passively collapsing comprises automatic collapsing of the lumen upon removal of the medical device from the lumen.

10. The combination of claim 1, wherein the bare section ranges from 0″

to 0.5″

from a proximal tip of the conduit-guide.

11. The combination of claim 1, wherein the spring load is inwardly directed to collapse the lumen from the opened diameter to the closed diameter.

12. The combination of claim 1, wherein individual wires of the braided wire of the bare section are individually coated.

13. The combination of claim 1, wherein the medical device comprises a cannula.

14. The combination of claim 1, wherein the medical device comprises at least one member of the group consisting of a scope, a light, and a camera.

15. A method for positioning a medical device within a human or an animal patient having a skin, the method comprising:

positioning a proximal end of a conduit-guide in or adjacent a wall of the patient,

the conduit-guide comprising a body encompassing a lumen, wherein the body of the conduit-guide is capable of actively expanding the lumen from a closed diameter to an opened diameter and passively collapsing the lumen from the opened diameter to the closed diameter;

positioning a distal end of the conduit-guide through the skin of the patient to externally communicate the lumen of the conduit-guide with an external environment outside of the patient, to thus define an operative position of the conduit-guide, 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 conduit-guide with the external environment outside of the patient; and

when the conduit-guide is in the operative position, introducing the medical device into the conduit-guide, thereby actively expanding the lumen from the closed diameter to the opened diameter.

16. The method of claim 15, further comprising removing the medical device from the conduit-guide, whereby the conduit-guide is collapsed.

17. The method of claim 15, wherein prior to the positioning steps, the conduit-guide is part of an assembly of the conduit-guide encased in a sheath.

18. The method of claim 17, wherein the sheath comprises a pusher-device, the method further comprising removing the sheath by the pusher-device when the conduit-guide is in the operative position.

19. The method of claim 15, further comprising fixing the proximal end of the conduit-guide by a suture to the wall.

20. The method of claim 15, wherein the medical device comprises a cannula.

21. The method of claim 15, wherein the medical device comprises at least one member of the group consisting of a scope, a light, and a camera.

22. The method of claim 15, wherein the wall of the patient is a wall of an organ or a vessel of the patient.

23. The method of claim 22, wherein the organ or the vessel of the patient is the patient'"'"'s heart.