Devices and methods for anchoring a sheath in a tissue cavity
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.
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 pressure tube in fluid connection with an outer surface of the sleeve; and
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 an end in sealed fluid communication with, and extending distal to, a distal end of the sleeve, wherein the 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;
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 between (i) the outer surface 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, that substantially prevents displacement of the sleeve in an axial direction.
2. The anchoring system of claim 1 , further comprising a first sealing mechanism disposed on a first end of the sleeve and a second sealing mechanism disposed on a second end of the sleeve.
3. The anchoring system of claim 2 , wherein at least one of the sleeve, the first sealing mechanism, or the second sealing mechanism are compressible by normal peristaltic forces of a patient's bowel.
4. The anchoring system of claim 2 , wherein the first and second sealing mechanisms form a substantially airtight and fluid-tight seal with an undamaged area of the tissue of the tissue cavity.
5. The anchoring system of claim 2 , wherein the first and second sealing mechanisms comprise one 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 an undamaged area of the tissue of the tissue cavity when negative pressure is delivered through the pressure tube.
6. The anchoring system of claim 2 , wherein the first and second sealing mechanisms comprise a rounded protrusion or multiple protrusions placed in series that are compressible.
7. The anchoring system of claim 2 , wherein a diameter of each of the first sealing mechanism and the second sealing mechanism is less than or equal to a diameter of the tissue cavity at an undamaged area of the tissue of the tissue cavity.
8. The anchoring system of claim 2 , further comprising a connector tube coupling the pressure tube to the sleeve, the connector tube extending through one of the first sealing mechanism and the second sealing mechanism and having an opening on the outer surface of the sleeve.
9. The anchoring system of claim 8 , wherein the connector tube includes a one-way valve therein.
10. The anchoring system of claim 2 , 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.
11. The anchoring system of claim 2 , wherein the sealed configuration of the sleeve that substantially prevents displacement of the sleeve in an axial direction is due to friction forces between (i) the outer surface of the sleeve and the first and second 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.
12. The anchoring system of claim 1 , further comprising a surface material disposed on the outer surface of the sleeve, wherein the surface material is a stacked mesh matrix, a honey-comb lattice of interconnected channels oriented in a radial fashion around the sleeve, a gauze, a fabric, a three-dimensional woven material, or open-cell foam.
13. The anchoring system of claim 1 , wherein the first lumen of the sleeve has a diameter between approximately 1 cm and approximately 6 cm.
14. The anchoring system of claim 1 , wherein the sleeve comprises a flexible material having a Shore A hardness between about 20A and about 70A.
15. The anchoring system of claim 1 , further comprising the negative pressure source, wherein negative pressure is applied to the pressure tube by the negative pressure source to maintain a negative pressure at a level between −50 mmHg and −200 mmHg.
16. The anchoring system of claim 1 , wherein the sheath has a length that allows it to extend outside the tissue cavity.
17. The anchoring system of claim 1 , wherein the sleeve has a length that is between about 3 cm and about 25 cm.
18. The anchoring system of claim 1 , further comprising a plurality of pressure tubes in fluid connection with the outer surface of the sleeve.
19. The anchoring system of claim 2 , wherein the sleeve, the first sealing mechanism, and the second sealing mechanism form a first anchoring element, with 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 damaged area of the tissue of the tissue cavity, and
wherein the port is in communication with the sealed off space to allow access from outside the tissue cavity for fluid delivery and withdrawal.
20. A delivery system comprising:
the anchoring system of claim 1 ; and
an endoscope configured to place the anchoring system into position in a tissue cavity.
21. The delivery system of claim 20 , wherein the anchoring system is releasably attached to the endoscope.
22. The delivery system of claim 21 , wherein the anchoring system is attached to an end of the endoscope via a releasable clip.