Devices and methods for anchoring a sheath in a tissue cavity

• US 9,827,135 B2
• Filed: 09/15/2016
• Issued: 11/28/2017
• Est. Priority Date: 09/15/2015
• Status: Active Grant

• Current Assignee: Savage Medical Inc.
• Original Assignee: Savage Medical Inc.
• Inventors: Fong, Kenton D., Lee, Jan, Etter, Jeffrey W.
• Primary Examiner(s): Scherbel, Todd J
• Assistant Examiner(s): Townsend, Guy K
• Application Number:
  US15/266,976
• Publication Number:
  US 20170071780A1
• Time in Patent Office: 439 Days
• CPC Class Codes: A61F 2002/045 Stomach, intestines
• CPC Class Codes: A61F 5/4408 Means for securing receptacles or bags to the body otherwise than by adhesives, e.g. belts, straps or harnesses A61F5/449 takes precedence
• CPC Class Codes: A61F 5/449 Body securing means, e.g. belts, garments

Abstract

According to some embodiments of the invention, an anchoring system includes a sleeve having an inner surface defining a first lumen, a first annular sealing mechanism disposed at a proximal end of the sleeve, and a second annular sealing mechanism disposed at a distal end of the sleeve. The anchoring system further includes a pressure tube in fluid connection with an outer surface of the sleeve, a sheath in mechanical connection with the sleeve, the sheath forming a second lumen, the second lumen being in fluid connection with the first lumen, and open-cell foam disposed on the outer surface of the sleeve. Application of negative pressure to the pressure tube causes a seal to form between the first and second annular sealing mechanisms and an inner surface of a tissue cavity. Application of negative pressure to the pressure tube also creates a frictional force that resists displacement of the sleeve.

Claims

1. An anchoring system, comprising:

a sleeve having an inner surface defining a first lumen, wherein the sleeve is configured to be disposed in a tissue cavity proximal to a damaged area of tissue of the tissue cavity;

a first annular sealing mechanism disposed at a proximal end of the sleeve;

a second annular sealing mechanism disposed at a distal end of the sleeve;

a pressure tube in fluid connection with an outer surface of the sleeve;

a sheath in connection with the sleeve, the sheath forming a second lumen, the second lumen being in fluid connection with the first lumen of the sleeve, the sheath having a proximal end in sealed fluid communication with, and extending distal to, a distal end of the sleeve and the second annular sealing mechanism, wherein the proximal end of the sheath, extending distal to the distal end of the sleeve, is configured to cover and protect the damaged area of the tissue of the tissue cavity from content flowing through the second lumen of the sheath and the first lumen of the sleeve; and

open-cell foam disposed on the outer surface of the sleeve,

wherein the anchoring system is configured to apply negative pressure by an external negative pressure source to the pressure tube to form a sealed configuration of the sleeve that substantially prevents displacement of the sleeve in an axial direction due to friction forces between (i) the open-cell foam and the first and second annular sealing mechanisms of the sleeve; and

(ii) the tissue of the tissue cavity proximal to and at a different location from the damaged area of the tissue of the tissue cavity.

2. An anchoring system according to claim 1, wherein the application of negative pressure to the pressure tube brings the open-cell foam disposed on the outer surface of the sleeve into contact with the tissue of the tissue cavity thereby creating the frictional force that resists displacement of the sleeve.

3. An anchoring system according to claim 1, wherein the first and second annular sealing mechanisms form a substantially airtight and fluid-tight seal with the tissue of the tissue cavity.

4. An anchoring system according to claim 1, wherein the sheath protects the tissue of the tissue cavity from fecal flow distal to the sleeve.

5. An anchoring system according to claim 1, wherein the first lumen has a diameter between approximately 1 cm and approximately 6 cm, or wherein the outer surface of the sleeve has a diameter between approximately 1.1 cm and approximately 6.1 cm.

6. An anchoring system according to claim 1, wherein the open-cell foam comprises a material having an average pore size between about 50 microns and about 1000 microns.

7. An anchoring system according to claim 1, wherein the open-cell foam is compressible by peristaltic contractions of a patient'"'"'s bowel.

8. An anchoring system according to claim 1, wherein the sleeve comprises a flexible material having a Shore A hardness between about 20 A and about 70 A.

9. An anchoring system according to claim 1, wherein the open-cell foam comprises polyvinyl alcohol, polyurethane foam, or other synthetic polymer, or wherein the open-cell foam has a tensile strength of at least 50 kpa.

10. An anchoring system according to claim 1, wherein the open-cell foam has a thickness of between 2 mm and 150 mm.

11. An anchoring system according to claim 1, wherein the first and second annular sealing mechanisms comprise a flexible material having a Shore A hardness between about 20 A and about 70 A.

12. An anchoring system according to claim 1, wherein the first and second annular sealing mechanisms have an annular diameter that is greater than an annular diameter of the open-cell foam dispersed around the sleeve.

13. An anchoring system according to claim 1, wherein the first and second annular sealing mechanisms comprise two or more tapered fins placed in series on each end of the sleeve with an orientation directed away from a center of the sleeve so that the one or more tapered fins lie flat against the inner surface of the tissue cavity when negative pressure is delivered through the pressure tube.

14. An anchoring system according to claim 1, wherein the first and second annular sealing mechanisms comprise a rounded protrusion or multiple protrusions placed in series at each end of the sleeve that are compressible.

15. An anchoring system according to claim 1, further comprising the external negative pressure source, wherein negative pressure is applied to the pressure tube by the external negative pressure source to maintain constant negative pressure at a level between −

50 mmHg and −

200 mmHg.

16. An anchoring system according to claim 1, wherein the sheath has a length that allows it to extend outside the tissue cavity.

17. An anchoring system according to claim 1, wherein the first lumen, second lumen, and first and second annular sealing mechanisms are compressible by normal peristaltic forces of a patient'"'"'s bowel.

18. An anchoring system according to claim 1, wherein the sleeve has a length that is between about 3 cm and about 25 cm.

19. An anchoring system according to claim 1, wherein the sleeve, first and second sealing mechanisms, and sheath are comprised of one or more of silicone, polyurethane, thermoplastic elastomer, rubber, rubber-like material, or other polymer.

20. An anchoring system according to claim 1, further comprising a plurality of pressure tubes in fluid connection with the outer surface of the sleeve.

21. An anchoring system according to claim 1, wherein the sleeve, the first annular sealing mechanism, and second annular sealing mechanism form a first anchoring element, the anchoring system further comprising:

a second anchoring element in mechanical connection with the sheath, the second anchoring element disposed apart from and distal to the first anchoring element; and

a port disposed between the first anchoring element and the second anchoring element,

wherein the sheath, the first anchoring element, and the second anchoring element create a sealed off space between the first and second anchoring elements, the sheath, and the tissue of the tissue cavity, and

wherein the port is in communication with the sealed off space to allow access from outside a patient'"'"'s body for fluid delivery and withdrawal.

22. An anchoring system according to claim 1, wherein a diameter of the first annular sealing mechanism and the second annular sealing mechanism is less than or equal to a diameter of the tissue cavity in which the sheath is to be anchored.

23. A delivery system, comprising:

a flexible tubular membrane that encases the anchoring system according to claim 1; and

a semi-rigid tube pusher with a proximal end, a distal end, and a center,

wherein the anchoring system is configured to be pushed into position by advancing the semi-rigid tube pusher into a patient'"'"'s bowel; and

wherein the flexible tubular membrane invaginates down the proximal end and out the distal end of the semi-rigid tube pusher.

24. An anchoring system according to claim 1, wherein the tissue cavity is a bowel and the damaged area of the tissue of the tissue cavity is an anastomosis.

25. A temporary anchoring device for diverting fecal flow through a bowel lumen, comprising:

a sleeve having an inner surface defining a first lumen, wherein the sleeve is configured to be disposed in the bowel lumen proximal to a damaged area of tissue of the bowel lumen;

a first annular sealing mechanism disposed at a proximal end of the sleeve;

a second annular sealing mechanism disposed at a distal end of the sleeve;

a pressure tube in fluid connection with an outer surface of the sleeve;

a sheath in connection with the sleeve, the sheath forming a second lumen, the second lumen being in fluid connection with the first lumen of the sleeve, the sheath having a proximal end in sealed fluid communication with, and extending distal to, a distal end of the sleeve and the second annular sealing mechanism, wherein the proximal end of the sheath, extending distal to the distal end of the sleeve, is configured to cover and protect the damaged area of the tissue of the bowel lumen from fecal flow through the sheath; and

air conducting rough surface material disposed on the outer surface of the sleeve,

wherein the anchoring system is configured to apply negative pressure by an external negative pressure source to the pressure tube to form a sealed configuration of the sleeve that substantially prevents displacement of the sleeve in an axial direction due to friction forces between (i) the air conducting rough surface material and the first and second annular sealing mechanisms of the sleeve and (ii) an area of the tissue of the bowel lumen proximal to and at a different location from the damaged area of the tissue of the bowel lumen.

26. A temporary anchoring device for diverting fecal flow through a bowel lumen according to claim 25, where the air conducting rough material is a stacked mesh matrix, a honey-comb lattice of interconnected channels oriented in a radial fashion around the sleeve, gauze, fabric, or a three-dimensional woven material.

27. A method for anchoring a sheath in a tissue cavity, the sheath being in connection with a sleeve and extending distal to the sleeve, the sleeve having an outer surface comprising foam for contacting an area of tissue of the tissue cavity, an inner surface defining a first lumen, and a sealing mechanism for isolating a portion of the tissue of the tissue cavity adjacent to the sleeve from a remainder of the tissue cavity, the sheath forming a second lumen, the second lumen being in fluid connection with the first lumen of the sleeve, the sheath having a proximal end in sealed fluid communication with, and extending distal to, a distal end of the sleeve and the sealing mechanism, the method comprising:

inserting the sleeve in the tissue cavity such that the sleeve is proximal to a damaged area of tissue of the tissue cavity and the sheath covers and protects the damaged area of the tissue of the tissue cavity from content flowing through the sheath and the sleeve; and

applying a negative pressure to a region between an outer surface of the sleeve and the isolated portion of the tissue of the tissue cavity to form a sealed configuration of the sleeve that substantially prevents displacement of the sleeve in an axial direction due to friction forces between (i) the outer surface of the sleeve comprising foam and the sealing mechanism; and

(ii) an area of tissue of the tissue cavity proximal to and at a different location from the damaged area of the tissue of the tissue cavity.