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;
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; and
a negative pressure system having a source of negative pressure coupled to the sleeve via the pressure tube, the negative pressure system configured to create a vacuum to cause the sleeve to remain in place in the tissue cavity at an anchor site proximal to the damaged area of tissue of the tissue cavity,
wherein the sleeve is configured to stay in place at the anchor site proximal to the damaged area of tissue of the tissue cavity during peristalsis of a patient's bowel.
2 . The anchoring system according to claim 1 , further comprising an indicator configured to indicate when sufficient negative pressure has been achieved and/or is being maintained by the negative pressure system.
3 . The anchoring system according to claim 2 , wherein the indicator is a pressure gauge.
4 . The anchoring system according to claim 1 , wherein the negative pressure system comprises one of an electric pump mechanism or a mechanical pump mechanism.
5 . The anchoring system according to claim 1 , wherein the negative pressure system is further configured to apply a positive pressure to cause the sleeve to be released from the anchor site proximal to the damaged area of tissue of the tissue cavity.
6 . The anchoring system according to claim 1 , wherein the negative pressure system is configured to apply negative pressure to the pressure tube to maintain a negative pressure at a level between −50 mmHg and −200 mmHg.
7 . The anchoring system according to claim 1 , wherein the sleeve further comprises:
(a) a first sealing mechanism disposed at a proximal end of the sleeve; and
(b) a second sealing mechanism disposed at a distal end of the sleeve.
8 . The anchoring system according to claim 7 , 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 applied to the pressure tube.
9 . The anchoring system according to claim 7 , 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.
10 . The anchoring system according to claim 7 , 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.
11 . The anchoring system according to claim 10 , wherein the connector tube includes a one-way valve therein.
12 . The anchoring system according to claim 7 , 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.
13 . The anchoring system according to claim 1 , further comprising an irrigation system in fluid connection with the pressure tube, wherein the irrigation system is configured to introduce a fluid into the pressure tube for irrigation.
14 . The anchoring system according to claim 1 , further comprising a plurality of pressure tubes in fluid connection with the outer surface of the sleeve.
15 . The anchoring system according to claim 1 , further comprising a flexible membrane that encases at least the sleeve of the anchoring system.
16 . The anchoring system according to 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.
17 . The anchoring system according to claim 1 , wherein the sheath has a length that allows it to extend outside the tissue cavity.
18 . The anchoring system according to claim 1 , wherein the sleeve has a length that is between about 3 cm and about 25 cm.
19 . The anchoring system according to claim 1 , further comprising a collection bag in fluid connection with the sheath, wherein the collection bag is configured to receive GI content flowing through the sheath.
20 . The anchoring system according to claim 1 , wherein the sleeve is configured to be introduced into the tissue cavity through an anal canal of a patient using an endoscope.
21 . The anchoring system according to claim 20 , wherein the anchoring system is releasably attached to the endoscope.
22 . The anchoring system according to claim 21 , wherein the anchoring system is attached to an end of the endoscope via a releasable clip.
23 . The anchoring system according to claim 1 , wherein the sleeve is configured to stay in place in the tissue cavity at the anchor site proximal to the damaged area of tissue for an extended period of time until the sleeve is removed by a doctor.