Soft tissue fixation devices
Remodeling of body tissue using a bioabsorbable implant that maintains or otherwise mechanically assists a more permanent implant or other treatment take, for example, by the treatment causing fibrosis. For example, the apparatus and methods can be used for hernia, organ prolapse and cosmetic purposes, such as breast and face lifts.
1. A method of treating vaginal prolapse of a patient, the method comprising:
a. providing a prosthesis comprising inflatable bioabsorbable implant and a permanent implant, wherein:
i. the inflatable bioabsorbable implant is a seamless balloon comprising two flattened surfaces facing in opposite directions, configured to regulate tissue adhesion and to separate tissues by inflation; and
ii. the permanent implant comprises a mesh and is attached to only a given one of the two flattened surfaces of the bioabsorbable implant so that only one of the two flattened surfaces faces the permanent implant, the permanent implant being adapted to cause a soft tissue reaction of adhesion to reinforce said adjacent tissue;
b. positioning the permanent implant between the vaginal tissue and other tissue of the patient;
c. inflating the bioabsorbable seamless balloon so that (i) during the inflation, the fluid enters into the seamless balloon via a tube that is parallel to the given one of the flattened surfaces; and (ii) the inflation drives separation of the vaginal tissue from the other tissue;
d. sealing the inflated bioabsorbable and seamless balloon;
e. allowing the inflated and sealed bioabsorbable balloon to biodegrade or bioabsorb after the permanent implant is fixed by fibrosis tissue.
2. The method of claim 1 wherein said flattened surfaces are flat when said inflatable bioabsorbable implant is inflated.
3. The method of claim 1 wherein the sealed and inflated bioabsorbable balloon is used to anchors the mesh in its place until the mesh sets to tissue.
4. The method of claim 3 wherein, in step (d), the inflated bioabsorbable and seamless balloon is sealed so that a pressure therewithin exceeds one atmosphere.
5. The method of claim 3 wherein the sealed and inflated bioabsorbable balloon remains inflated within the body for at least a few weeks.
6. The method of claim 3 wherein the sealed and inflated bioabsorbable balloon remains inflated within the body for few weeks to a few months.
7. The method of claim 1 wherein the sealed and inflated bioabsorbable balloon remains inflated within the body for at least a few weeks.
8. The method of claim 7 wherein, in step (d), the inflated bioabsorbable and seamless balloon is sealed so that a pressure therewithin exceeds one atmosphere.
9. The method of claim 1 wherein the sealed and inflated bioabsorbable balloon remains inflated within the body for few weeks to a few months until tissue ingrowth to the mesh occurs.
10. The method of claim 1 wherein, in step (d), the inflated bioabsorbable and seamless balloon is sealed so that a pressure therewithin exceeds one atmosphere.
11. The method of claim 10 wherein, in step (d), the inflated bioabsorbable and seamless balloon is sealed by a bioabsorbable plug.
12. The method of claim 1 wherein the balloon has only a single opening, and step (d) is performed by sealing the single opening of the balloon.
13. A method of treating vaginal prolapse of a patient, the method comprising:
a. providing a prosthesis comprising inflatable bioabsorbable implant and a permanent implant, wherein:
i. the inflatable bioabsorbable implant is a seamless balloon comprising two flattened surfaces facing in opposite directions, configured to regulate tissue adhesion and to separate tissues by inflation; and
ii. the permanent implant comprises a mesh and is attached to only a given one of the two flattened surfaces of the bioabsorbable implant so that only one of the two flattened surfaces faces the permanent implant, the permanent implant being adapted to cause a soft tissue reaction of adhesion to reinforce said adjacent tissue;
b. positioning the permanent implant between the vaginal tissue and other tissue of the patient;
c. inflating the bioabsorbable seamless balloon so that (i) during the inflation, the fluid enters into the seamless balloon via a tube that is parallel to the given one of the flattened surfaces; and (ii) the inflation drives separation of the vaginal tissue from the other tissue;
d. sealing the inflated bioabsorbable and seamless balloon;
e. allowing the inflated and sealed bioabsorbable balloon to biodegrade or bioabsorb after the permanent implant is fixed by fibrosis tissue, wherein the inflated and sealed bioabsorbable balloon remains attached to the mesh to maintain a shape of the mesh until the mesh sets to tissue.
14. The method of claim 13 wherein said flattened surfaces are flat when said inflatable bioabsorbable implant is inflated.
15. The method of claim 13 wherein the sealed and inflated bioabsorbable balloon is used to anchor the mesh in its place until the mesh sets to tissue.
16. The method of claim 15 wherein, in step (d), the inflated bioabsorbable and seamless balloon is sealed so that a pressure therewithin exceeds one atmosphere.
17. The method of claim 15 wherein the sealed and inflated bioabsorbable balloon remains inflated within the body for few weeks to a few months.
18. The method of claim 13 wherein the sealed and inflated bioabsorbable balloon remains inflated within the body for few weeks to a few months until tissue ingrowth to the mesh.
19. The method of claim 18 wherein, in step (d), the inflated bioabsorbable and seamless balloon is sealed by a bioabsorbable plug.
20. The method of claim 13 wherein the balloon has only a single opening, and step (d) is performed by sealing the single opening of the balloon.