Conductive and degradable implant for pelvic tissue treatment
Described is a pelvic implant comprising a biodegradable conductive mesh. The mesh can include biodegradable and electrically conductive polymer, and can be stimulated with a current to generate an electric field to promote an improved tissue response following placement of the implant. The invention also describes methods and systems including the pelvic implant comprising a biodegradable conductive mesh for the treatment of pelvic floor conditions. Implants of the invention provide benefits relating to improved tissue integration into the mesh, resulting in pelvic tissue reconstruction. Tissue reconstruction and elimination of the mesh materials can lead to a better clinical outcome for the patient.
1. A medical device:
a mesh implant having a plurality of biodegradable conductive fibers, the plurality of biodegradable conductive fibers including a first type filament and a second type filament, the first type filament being a conductive polymer and the second type filament being a mixture of a coated biodegradable conductive fiber including a core constructed from a biodegradable polymer and a conductive coating constructed from an electrically conductive polymer, the conductive coating covering less than 50% of an outer surface of the core,
the mesh implant having a first end portion including a first end and a second end portion including a second end, the mesh implant including a first portion, a second portion, and a third portion, the first portion being disposed on the first end portion and defining a first electrode segment having first coated biodegradable conductive fiber portions, the second portion being disposed on the second end portion and defining a second electrode segment having second coated biodegradable conductive fiber portions, the third portion being disposed between the first end portion and the second end portion and having third coated biodegradable conductive fiber portions, the first electrode segment and the second electrode segment having greater concentrations of the conductive polymer than the third portion of the mesh implant;
a first lead configured to be coupled to the first electrode segment; and
a second lead configured to be coupled to the second electrode segment.
2. The medical device of claim 1 , wherein the biodegradable polymer is selected from the group consisting of polyesters, polyhydroxyalkanoates, polyorthoesters, polyalkeneanhydrides, and polyanhydrides.
3. The medical device of claim 1 , wherein the coated biodegradable conductive fiber is in the form of a monofilament.
4. The medical device of claim 1 , wherein the conductive coating has a thickness in a range of about 0.5 μm to about 25 μm.
5. The medical device of claim 1 , wherein the mesh implant includes a woven structure.
6. The medical device of claim 1 , wherein the conductive coating has a thickness in a range of about 1 μm to about 10 μm.
7. The medical device of claim 1 , wherein the conductive coating includes a concentration of polyaniline in a range of 0.5 to about 10%.
8. The medical device of claim 1 , wherein the electrically conductive polymer is selected from the group consisting of polyaniline, polypyrrole and polythiophene.
9. The medical device of claim 1 , wherein the electrically conductive polymer comprises polypyrrole.
10. The medical device of claim 1 , wherein the electrically conductive polymer comprises polyaniline.
11. The medical device of claim 1 , wherein the electrically conductive polymer covers less than 10% of the outer surface of the core.
12. The medical device of claim 1 , wherein the electrically conductive polymer covers less than 5% of the outer surface of the core.
13. The medical device of claim 1 , wherein the electrically conductive polymer covers only one side of the outer surface of the core.
14. The medical device of claim 13 , wherein the covered electrically conductive polymer is continuous from one electrode attachment to another electrode attachment point.
15. A system comprising:
a mesh implant configured for placement at a pelvic floor tissue, the mesh implant including a plurality of biodegradable conductive fibers, the plurality of biodegradable conductive fibers including a first type filament and a second type filament, the first type filament being a conductive polymer and the second type filament being a mixture of a coated biodegradable conductive fiber including a core constructed from a biodegradable polymer and a conductive coating constructed from an electrically conductive polymer, the electrically conductive polymer being disposed around an outer surface of the core,
the mesh implant having a first end portion including a first end and a second end portion including a second end, the mesh implant including a first portion, a second portion, and a third portion, the first portion being disposed on the first end portion and defining a first electrode segment having first coated biodegradable conductive fiber portions, the second portion being disposed on the second end portion and defining a second electrode segment having second coated biodegradable conductive fiber portions, the third portion being disposed between the first end portion and the second end portion and having third coated biodegradable conductive fiber portions, the first electrode segment and the second electrode segment having greater concentrations of the conductive polymer than the third portion of the mesh implant;
a first lead configured to be coupled to the first electrode segment;
a second lead configured to be coupled to the second electrode segment; and
an electrical stimulator unit coupled to the first lead and the second lead, the electrical stimulator unit configured to generate a current through the mesh implant.
16. The system of claim 15 , wherein the monofilament includes at least one groove along a length of the monofilament.
17. A method for treating pelvic floor tissues, the method comprising:
(a) placing a mesh implant at a pelvic floor tissue, the mesh implant including a plurality of biodegradable conductive fibers, the plurality of biodegradable conductive fibers including a first type filament and a second type filament, the first type filament being a conductive polymer and the second type filament being a mixture of a coated biodegradable conductive fiber including a core constructed from a biodegradable polymer and a conductive coating constructed from an electrically conductive polymer, the conductive coating covering less than 50% of an outer surface of the core,
the mesh implant having a first end portion and a second end portion, the mesh implant consisting of a first portion, a second portion, and a third portion, the first portion being disposed on the first end portion and defining a first electrode segment having first coated biodegradable conductive fiber portions, the second portion being disposed on the second end portion and defining a second electrode segment having second coated biodegradable conductive fiber portions, the third portion being disposed between the first end portion and the second end portion and having third coated biodegradable conductive fiber portions, the first electrode segment and the second electrode segment having greater concentrations of the conductive polymer than the third portion of the mesh implant, wherein a first lead is coupled to the first electrode segment, and a second lead is coupled to the second electrode segment;
(b) generating a current through the mesh implant to promote a tissue healing response; and
(c) allowing the mesh implant to degrade at the site of placement.