Anastomosis Devices
Implantable medical devices for connecting tissue layers, such as for connecting a gallbladder and a portion of a gastrointestinal tract to create an anastomosis, include a tubular structure having a plurality of apposition portions, a central region, and a covering material. The methods of using the devices include endoscopic deployment, and the devices may include self-expanding frameworks that facilitate a secure connection between the tissue structures.
1 . A medical device comprising:
an expandable frame having a first end, a second end, and a middle portion between said first end and said second end;
a first apposition portion comprising a plurality of first apposition members, each of said first apposition members extending toward said middle portion, a first portion of each said first apposition members being oriented at a first angle in relation to a surface of said middle portion, a second portion of each said first apposition member being oriented at a second angle in relation to said surface of said middle portion, wherein said first angle is acute and is less than said second angle; and
a second apposition portion comprising a plurality of second apposition members, each of said second apposition member extending toward said middle portion, a first portion of each said first apposition members being oriented at a third angle in relation to said surface of said middle portion, a second portion of each said second apposition members being oriented at a fourth angle in relation to said surface of said middle portion, wherein said third angle is acute and is less than said fourth angle.
2 . The device of claim 1 , further comprising a covering material on at least a portion of said frame.
3 . The device of claim 2 , wherein the covering material spans between adjacent first apposition members or between adjacent second apposition members.
4 . The device of claim 1 , wherein the middle portion defines at least one lumen extending between said first end and said second end.
5 . The device of claim 1 , wherein at least one said first apposition members is configured differently than one or more others of said first apposition members.
6 . The device of claim 5 , wherein at least one said first apposition members is longer than one or more others of said first apposition members.
7 . The device of claim 1 , wherein at least one of said first apposition members is longer than at least one of said second apposition members.
8 . The device of claim 7 , wherein all of said first apposition members are longer than all of said second apposition members.
9 . The device of claim 1 , wherein said plurality of first apposition members are in axial alignment with said plurality of second apposition members.
10 . The device of claim 1 , wherein said plurality of first apposition members are axially unaligned with said plurality of second apposition members.
11 . The device of claim 10 , wherein one or more of said plurality of first apposition members longitudinally overlap with one or more of said plurality of second apposition members.
12 . A medical device comprising:
a frame comprising an elongate member defining:
a first apposition portion comprising one or more first flange members configured to contact a first tissue surface and to provide an apposition force against said first tissue surface;
a second apposition portion comprising one or more second flange members configured to contact a second tissue surface and to provide an apposition force against said second tissue surface; and
a central portion having a first end and a second end, said central portion defining a longitudinal axis, said central portion being disposed between and interconnecting said first apposition portion and said second apposition portion,
wherein at least one of said one or more first flange members and at least one of said second flange members comprises a radius portion and a descending portion that extends longitudinally toward said central portion,
wherein at least one of said radius portions of said one or more first flange members extends longitudinally beyond said first end, and
wherein at least one of said radius portions of said one or more second flange members extends longitudinally beyond said second end.
13 . The medical device of claim 12 , wherein at least one of said one or more first flange members or at least one of said one or more second flange members further comprises a horizontal portion extending from said descending portion.
14 . The medical device of claim 12 , wherein each of said one or more first flange members and each of said second flange members comprises a radius portion and a descending portion that extends longitudinally toward said central portion,
15 . The medical device of claim 12 , wherein said radius portions extend from said first end or said second end of said central portion.
16 . The medical device of claim 12 , wherein said descending portion is a linearly descending portion.
17 . The medical device of claim 12 , wherein the central portion defines a lumen extending between said first end and said second end.
18 . The medical device of claim 12 , wherein the central portion is configured to longitudinally extend and retract to maintain contact, over a range of tissue thicknesses, of the first and second apposition portions with the first and second tissue surfaces respectively.
19 . A method of implanting an anastomosis device in a patient:
positioning a delivery sheath containing the anastomosis device at a target location within the patient, wherein the anastomosis device comprises:
an expandable frame having a first end, a second end, and a middle portion between said first end and said second end;
a first apposition portion comprising a plurality of first apposition members, each said first apposition member extending toward said middle portion, a first portion of each said first apposition member being oriented at a first angle in relation to a surface of said middle portion, a second portion of each said first apposition member being oriented at a second angle in relation to said surface of said middle portion, wherein said first angle is acute and is less than said second angle; and
a second apposition portion comprising a plurality of second apposition members, each said second apposition member extending toward said middle portion, a first portion of each said second apposition member being oriented at a third angle in relation to said surface of said middle portion, a second portion of each said second apposition member being oriented at a fourth angle in relation to said surface of said middle portion, wherein said third angle is acute and is less than said fourth angle; and
deploying the anastomosis device out from the delivery sheath such that at least one layer of tissue is between said first apposition portion and said second apposition portion.
20 . The method of claim 19 , wherein a tip portion of said plurality of first apposition members or said plurality of second apposition members is spaced apart from said tissue.
21 . The method of claim 19 , wherein two layers of tissue are between said first apposition portion and said second apposition portion.