Implantable prosthesis and method and apparatus for loading and delivering an implantable prosthesis

• US 5,695,525 A
• Filed: 06/07/1995
• Issued: 12/09/1997
• Est. Priority Date: 05/20/1992
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Inventors: DiCesare, Paul C., Mulhauser, Paul J.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/485,714
• Time in Patent Office: 916 Days
• Field of Search: 623/11, 623/12, 623/66, 600/37, 606/151, 606/152, 606/200, 606/213, 606/110, 606/113, 606/114, 604/11-15
• US Class Current: 606/151
• CPC Class Codes: A61B 17/00234 for minimally invasive surgery A61B17/0218, A61B17/0469, A61B17/12013, A61B17/1285, A61B17/29, A61B17/320016 take precedence
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/02 Prostheses implantable into the body closure means for urethra or rectum or for artificial body openings therefor A61F2/0004
• CPC Class Codes: A61F 2002/0072 Delivery tools therefor
• CPC Class Codes: A61F 2002/009 for hindering or preventing attachment of biological tissue
• CPC Class Codes: B29C 2045/14885 by plasma treatment

Abstract

An implantable prosthesis and device and method for loading and delivering the implantable prosthesis to a trocar cannula. The implantable prosthesis includes a body portion sufficient to extend across and occlude a defect opening and a semi-rigid ring for supporting the body portion. The implantable prosthesis may be provided with a sufficient hoop strength to prevent the body portion from collapsing into the defect opening. A loading and delivery tool includes a main body with a lumen sized to collapse the implantable prosthesis. An elongated shaft is rotatable to wind the implant into a slender configuration and axially moveable to advance the rolled-up implant into the trocar cannula. A cartridge extends from the main body and holds the implant in a normal expanded configuration.

Claims

1. An implantable prosthesis for occluding the opening of a muscle or tissue defect, said implantable prosthesis comprising:

an implantable sheet of mesh fabric having a plurality of interstices constructed and arranged to allow tissue ingrowth, said implantable sheet of mesh fabric including a body portion constructed and arranged to cover the defect opening and at least one anchoring portion extending from said body portion and being securable to muscle or tissue adjacent the defect opening;

a pliable sheet of barrier material which does not substantially stimulate the formation of postoperative adhesions, said pliable sheet of barrier material being constructed and arranged to isolate said implantable sheet of mesh fabric from sensitive tissue to prevent adhesion of said implantable sheet of mesh fabric to the sensitive tissue; and

means for attaching said pliable sheet of barrier material to said implantable mesh fabric so that at least one portion of said pliable sheet of barrier material is moveable to reveal said at least one anchoring portion of said implantable sheet of mesh fabric but not said body portion to allow said at least one anchoring portion to be secured to the muscle or tissue adjacent the defect opening.

2. The implantable prosthesis recited in claim 1, further comprising:

an implantable hoop carried by said pliable implantable sheet of mesh fabric between said body portion and said at least one anchoring portion, said implantable hoop being constructed and arranged to circumscribe the defect opening and being stiffer than said body portion.

3. The implantable prosthesis recited in claim 2 wherein said implantable prosthesis has a sufficient hoop strength to limit the deflection of said body portion into the defect opening when said hoop is positioned relative to the tissue or muscle defining the defect opening.

4. The implantable prosthesis recited in claim 2, wherein said at least one anchoring portion is co-planar with said body portion.

5. The implantable prosthesis recited in claim 2, wherein said at least one portion of said pliable sheet of barrier material is pivotable relative to said implantable hoop to reveal said at least one anchoring portion.

6. The implantable prosthesis recited in claim 2, wherein said at least one anchoring portion includes a plurality of anchoring portions uniformly spaced about said implantable hoop.

7. The implantable prosthesis recited in claim 2, wherein said implantable sheet of mesh fabric includes a substantially square shape and said hoop includes a substantially round shape, said hoop inscribing said implantable sheet of mesh fabric so that a portion of said implantable mesh fabric outside said hoop forms said at least one anchoring portion.

8. The implantable prosthesis recited in claim 1, wherein said pliable sheet of barrier material is attached to said implantable sheet of mesh fabric in a face-to-face relationship and said at least one portion of said pliable barrier material is liftable relative to said implantable sheet of mesh fabric to reveal said at least one anchoring portion.

9. The implantable prosthesis recited in claim 8, wherein said implantable sheet of mesh fabric has a fabric perimeter and said pliable sheet of barrier material has a barrier perimeter that is larger than said fabric perimeter.

10. The implantable prosthesis recited in claim 2, wherein said implantable hoop is integrally attached to said pliable implantable sheet of mesh fabric.

11. The implantable prosthesis recited in claim 7, wherein said implantable sheet of mesh fabric has comers and said at least one anchoring portion includes a plurality of anchoring portions disposed at said comers.

12. The implantable prosthesis recited in claim 1 in combination with a cannula, wherein said implantable prosthesis is supported in said cannula in a collapsed configuration for delivery to a surgical site.

13. A method of occluding the opening of a muscle or tissue defect, the method comprising steps of:

A. providing an implantable prosthesis comprised of,

an implantable sheet of mesh fabric having a plurality of interstices constructed and arranged to allow tissue ingrowth, the implantable sheet of mesh fabric including a body portion constructed and arranged to cover the defect opening and at least one anchoring portion extending from the body portion and being securable to muscle or tissue adjacent the defect opening;

a pliable sheet of barrier material which does not substantially stimulate the formation of postoperative adhesions, said pliable sheet of barrier material being constructed and arranged to isolate said implantable sheet of mesh fabric from sensitive tissue to prevent adhesion of said implantable sheet of mesh fabric to the sensitive tissue; and

means for attaching the pliable sheet of barrier material to the implantable mesh fabric so that at least one portion of the pliable sheet of barrier material is moveable to reveal the at least one anchoring portion of the implantable sheet of mesh fabric but not the body portion to allow said at least one anchoring portion to be secured to the muscle or tissue adjacent the defect opening;

B. positioning the implantable prosthesis so that the body portion covers the defect opening;

C. moving the at least one portion of the pliable sheet of barrier material to reveal the at least one anchoring portion of the implantable sheet of mesh fabric;

D. securing the at least one anchoring portion of the implantable sheet of mesh fabric to the muscle or tissue; and

E. covering the at least one anchoring portion of the implantable sheet of mesh fabric with the at least one portion of the pliable sheet of barrier material.

14. An implantable prosthesis for occluding the opening of a muscle or tissue defect, said implantable prosthesis comprising:

an implantable sheet of mesh fabric having a plurality of interstices constructed and arranged to allow tissue ingrowth, said implantable sheet of mesh fabric including a body portion constructed and arranged to cover the defect opening and at least one anchoring portion extending from said body portion and being securable to muscle or tissue adjacent the defect opening; and

a pliable sheet of barrier material which does not substantially stimulate the formation of postoperative adhesions, said pliable sheet of barrier material being constructed and arranged to isolate said implantable sheet of mesh fabric from sensitive tissue to prevent adhesion of said implantable sheet of mesh fabric to the sensitive tissue;

wherein said pliable sheet of barrier material is attached to said implantable mesh fabric so that at least one portion of said pliable sheet of barrier material is moveable to reveal said at least one anchoring portion of said implantable sheet of mesh fabric but not said body portion to allow said at least one anchoring portion to be secured to the muscle or tissue adjacent the defect opening.