Pelvic implants and methods of making and using thereof
Pelvic implant having a frame with two arms and a sheet are disclosed. The sheet may be held under tension in the assembled implant. The implant may be planar (flat) or may be non-planar. The implant may be contoured laterally. A curved non-planar implant may be convex or concave in a rostro-caudal direction. The implants may (optionally) include two additional arms and a second sheet for supporting a urethra and/or a bladder neck. Methods for constructing and assembling the implants are disclosed. A method ultrasonically welding the frame of the implant without thermally damaging the sheet is disclosed. Methods of implantation of the implants are disclosed.
1 . A device for implantation in a pelvis, the device comprising:
a frame comprising an elastic member having a first arm and a second arm; and
a sheet having a perimeter, said sheet being fixedly attached to said frame, wherein:
I. said elastic member has a compressed state and a relaxed state;
II. a restoring force of said elastic member serves to bias said elastic member from the compressed state towards the relaxed state so as to urge an increase in a distance between said first arm and said second arm, thereby holding said sheet at a portion of said perimeter under tension; and
III. a presence of the under-tension sheet between the first and second arms counteracts said restoring force so as to prevent the elastic member from reaching its relaxed state.
2 . The device according to claim 1 , wherein said frame has contoured lateral edges.
3 . The device according to claim 1 , wherein said device is a flat device and wherein said frame is a flat frame.
4 . The device according to claim 1 , wherein said device is a curved non-planar device, said frame is a non-planar frame, wherein said first arm and said second arm are curved to fit a curved pelvic region defined between a vagina and an organ of said pelvis.
5 . The device according to claim 4 , wherein at least one of the following is true: (A) said organ is a bladder and said first arm and second arm are curved to fit a curved pelvic region defined between said vagina and said bladder and (B) wherein said organ is a rectum and said first arm and second arm are curved to fit a curved pelvic region defined between said vagina and said rectum.
6 . The device according to claim 1 , wherein said frame has a proximal portion and a distal portion, said first arm and said second arm each have a proximal portion and a distal portion, and wherein the proximal portions of said first arm and said second arm are bent towards each other at an angle.
7 . The device according to claim 1 , wherein said sheet is selected from the group consisting of a mesh, a sheath, a diaphragm, a membrane, a multi-layered sheet and a divider.
8 . The device according to claim 1 , wherein said sheet has a substantially flat configuration.
9 . The device according to claim 1 , wherein said sheet is a biocompatible sheet comprising a material selected from the group consisting of a synthetic material, a polymer based material, a biological material, a collagen, a biodegradable material, and any combinations thereof.
10 . The device according to claim 1 , wherein in said assembled device a restoring force applied by said first arm and said second arm to said sheet to hold said sheet under tension is in the range of 0.001-2 Newton.
11 . The device of claim 1 wherein said sheet is permanently attached to said frame.
12 . The device according to claim 1 , wherein said frame is substantially flat to define (i) first and second lateral directions that are perpendicular to each other and (ii) a thickness direction which is perpendicular to both of the first and second lateral directions.
13 . The device according to claim 12 wherein the frame comprises first and second half-frames which are attached to each other along the thickness direction, said fixedly attached sheet sandwiched therebetween.
14 . The device according to claim 13 wherein said sheet is frictionally held between said first and second half-frames.
15 . The device of claim 1 wherein neither the first arm nor the second arm is part of a closed loop.
16 . The device of claim 15 wherein the frame comprises a U-shaped region, and said first and second arms are disposed on opposite sides of the U-shaped region of said frame.
17 . The device of claim 16 , wherein the sheet includes at least one frame-absent edge where no portion of said frame is present, said frame-absent edge being held under tension by said restoring force.
18 . The device of claim 16 , wherein the sheet includes at least one frame-absent edge where no portion of said frame is present, said frame-absent edge being held under tension by said restoring force.
19 . The device of claim 1 wherein the frame comprises a U-shaped region, and said first and second arms are disposed on opposite sides of the U-shaped region of said frame.
20 . The device of claim 19 , wherein the sheet includes at least one frame-absent edge where no portion of said frame is present, said frame-absent edge being held under tension by said restoring force.