Systems and methods for creating permanent drainage fistula
The present disclosure relates generally to the field of medical devices and establishing fluid communication between body lumens. In particular, the present disclosure relates to devices and methods for placing the muscularis layers of first and second body lumens in contact to establish a long term or permanent open flow or access passage therebetween.
1 . A medical device, comprising:
an elongate body forming a lumen and comprising a proximal portion and a distal portion;
the elongate body having an unexpanded configuration, and an expanded configuration, wherein the proximal portion self-expands into a proximal retention member and the distal portion self-expands into a distal retention member leaving a saddle region therebetween; and
a filament threaded through a portion of the elongate body, wherein the filament comprises one end affixed to the elongate body and another free end, and wherein the filament is configured to urge the expanded proximal and distal retention members toward each other.
2 . The medical device of claim 1 , wherein proximally retracting the free end of the filament urges the proximal and distal retention members toward each other.
3 . The medical device of claim 1 , wherein a surface of the proximal retention member is configured to contact an inner surface of a tissue wall of a first body lumen, and a surface of the distal retention member is configured to contact an inner surface of a tissue wall of a second body lumen.
4 . The medical device of claim 3 , wherein the surfaces of the proximal and distal retention members are configured to bring into apposition the tissue walls of the first and second body lumens between the proximal and distal retention members along the saddle region.
5 . The medical device of claim 4 , wherein the proximal retention member is configured to contact the inner surface of the tissue wall of the first body lumen at a substantially planar surface of the proximal retention member, wherein the distal retention member is configured to contact the inner surface of the tissue wall of the second body lumen at a substantially planar surface of the distal retention member, or wherein both the proximal and distal retention members are configured to contact the respective inners surfaces of the tissue walls of the first and second body lumens at the substantially planar surfaces of the proximal and distal retention members.
6 . The medical device of claim 4 , wherein the proximal retention member and the distal retention member are configured to apply a substantially consistent pressure to the tissue walls of the first and second body lumens apposed therebetween.
7 . The medical device of claim 6 , wherein the substantially consistent pressure is applied by the proximal and distal retention members about a full circumference of the saddle region.
8 . The medical device of claim 1 , wherein the affixed end of the filament is attached to the distal portion of the elongate body at a first location, and the free end of the filament is threaded from the first location along the saddle region to the proximal portion and back along the saddle region, terminating in the distal portion of the elongate body at a second location different from the first location.
9 . The medical device of claim 1 , further comprising a locking member attached to the elongate body adjacent to the free end of the filament.
10 . The medical device of claim 9 , wherein the locking member is configured to releasably secure or engage a first portion of the free end of the filament.
11 . The medical device of claim 10 , wherein the locking member is configured to releasably secure or engage a second portion of the free end of the filament, such that a distance, force, or both, between the proximal and distal retention members is adjustable.
12 . The medical device of claim 1 , wherein the affixed end of the filament is attached to the elongate body using one or more of a knot, glue, adhesive, resin, or other bonding technique.
13 . The medical device of claim 1 , wherein the elongate body is formed of a woven, knitted, or braided material.
14 . The medical device of claim 13 , wherein the filament is configured to slide through the woven, knitted, or braided material.
15 . The medical device of claim 1 , wherein the proximal and distal retention members extend approximately perpendicular from a longitudinal axis along the saddle region about a circumference of the elongate body.
16 . A method of delivering a medical device, comprising:
advancing a tissue-penetrating element from a first body lumen through to a second body lumen, wherein the tissue-penetrating element comprises a lumen and the medical device is disposed within the lumen for delivery, and wherein the medical device comprises an elongate body comprising a proximal portion, a distal portion, and a cylindrical saddle region therebetween;
expanding the distal portion of the medical device into a distal retention member within the second body lumen;
expanding the proximal portion of the medical device into a proximal retention member within the first body lumen; and
pulling on a filament affixed to the elongate body to urge the expanded proximal and distal retention members toward each other.
17 . The method of claim 16 , wherein a surface of the proximal retention member is configured to contact an inner surface of a tissue wall of the first body lumen, and a surface of the distal retention member is configured to contact an inner surface of a tissue wall of the second body lumen.
18 . The method of claim 17 , wherein pulling on the filament urges the tissue walls of the first and second body lumens into apposition between the proximal and distal retention members along the saddle region.
19 . The method of claim 16 , wherein the proximal retention member and the distal retention member are configured such that pulling on the filament applies a substantially consistent pressure to the tissue walls of the first and second body lumens apposed therebetween.
20 . The method of claim 16 , further comprising locking a locking member attached to the elongate body adjacent to the filament to establish a desired distance between the proximal and distal retention members.