Curved implantable sheath and method of making same

• US 6,685,625 B2
• Filed: 05/22/2001
• Issued: 02/03/2004
• Est. Priority Date: 09/26/2000
• Status: Expired due to Fees

• Current Assignee: Shlomo Gabbay
• Original Assignee: Shlomo Gabbay
• Inventors: Gabbay, Shlomo
• Primary Examiner(s): Chattopadhyay, Urmi
• Application Number:
  US09/862,955
• Publication Number:
  US 20020036221A1
• Time in Patent Office: 987 Days
• Field of Search: 623/1.1, 623/1.3, 623/1.31, 623/1.13, 623/11.11, 623/12, 623/66.1, 623/916, 623/921, 623/925, 623/23-4-, 623/901, 600/16, 600/36, 600/37, 606/151-158, 606/191, 606/194
• US Class Current: 600/36
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61F 2/0063 Implantable repair or support meshes, e.g. hernia meshes
• CPC Class Codes: A61F 2/04 Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts A61F2/18, A61F2/20 take precedence; devices, other than stent-grafts, providing patency to, or preventing collapsing of, tubular structures of the body other than stent-grafts, e.g. stents A61F2/82; instruments specially adapted for placement or removal of stents or stent-grafts A61F2/95
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2/062 Apparatus for the production of blood vessels made from natural tissue or with layers of living cells prostheses made from natural tissue or living cells A61L27/507
• CPC Class Codes: A61L 27/36 containing ingredients of undetermined constitution or reaction products thereof , e.g. transplant tissue, natural bone, extracellular matrix isolated natural compounds, e.g. collagen A61L27/24
• CPC Class Codes: A61L 27/3604 characterised by the human or animal origin of the biological material, e.g. hair, fascia, fish scales, silk, shellac, pericardium, pleura, renal tissue, amniotic membrane, parenchymal tissue, fetal tissue, muscle tissue, fat tissue, enamel
• CPC Class Codes: Y10S 623/901 Method of manufacturing prosthetic device

Abstract

A method for making a curved implantable sheath includes placing a sheet of flexible material into engagement with a member having a curved surface having a desired configuration. The sheet and member are placed in a fixation solution so that the sheet assumes the configuration of the surface engaged thereby.

Claims

1. A method for making a sheath having a curved contour, comprising:

providing a sheet of a biological tissue material, the sheet having ends spaced apart from each other by elongated side edges;

forming a generally tubular apparatus from the sheet of the biological tissue material, the forming comprising securing the side edges of the sheet of biological material relative to each other;

urging an elongated member having a curved exterior portion into the tubular apparatus, such that the relative spacing between the side edges of the sheet of biological material remains substantially unchanged;

placing the tubular apparatus and elongated member in a fixation solution so that at least part of the tubular apparatus is fixed to a configuration defined by the exterior portion of the elongated member engaged thereby;

separating the tubular apparatus from the elongated member to provide an elongated sheath of substantially biocompatible material having a curved contour corresponding to the curved exterior portion of the elongated member; and

removing a strip of tissue adjacent and coextensive at least one of the side edges of the sheet to form an elongated sheath having a curved contour that extends arcuately between opposite ends thereof and having a generally C-shaped cross section.

2. The method of claim 1, the elongated member having an outer diameter that approximates the diameter of the tubular apparatus.

3. The method of claim 1, the securing of the side edges further comprising suturing the side edges relative to each other to define a suture line that extends between the ends of the tubular apparatus.

4. The method of claim 1, wherein the biological tissue material comprises animal pericardium.

5. An elongated sheath produced according to claim 1, the elongated sheath having a curved contour extending arcuately between opposite ends thereof and having a generally C-shaped cross section.

6. A method for making a sheath having a curved contour, comprising:

providing a sheet of a biological tissue material, the sheet having ends spaced apart from each other by elongated side edges;

forming a generally tubular apparatus from the sheet of the biological tissue material, the forming further comprising securing the side edges of the sheet of biological material relative to each other by suturing to define a suture line that extends between the ends of the tubular apparatus;

urging an elongated member having a curved exterior portion into the tubular apparatus such that the relative spacing between the side edges of the sheet of biological material remains substantially unchanged;

placing the tubular apparatus and elongated member in a fixation solution so that at least part of the tubular apparatus is fixed to a configuration defined by the exterior portion of the elongated member engaged thereby;

separating the tubular apparatus from the elongated member to provide an elongated sheath of substantially biocompatible material having a curved contour corresponding to the curved exterior portion of the elongated member; and

removing the suture line to define an elongated sheath having a curved contour that extends arcuately between opposite ends thereof and having a generally C-shaped cross section.

7. An elongated sheath produced according to claim 6.

8. A method of making an implantable sheath having a curved contour, comprising:

providing a sheet of tissue, the sheet having ends spaced apart from each other by elongated side edges;

placing the sheet into engagement with a surface of an elongated member, the surface being curved along at least a portion of a long axis that extends between ends of the elongated member;

applying retaining elements to hold the sheet relative to the elongated member such that at least a substantial portion of the sheet engages the at least part of the curved surface of the elongated member during fixation;

fixing the sheet in a fixation solution while the sheet engages at least part of the curved surface of the elongated member so that at least part of the sheet assumes a contour defined by the at least part of the curved surface of the elongated member engaged by the sheet; and

separating the sheet relative from the elongated member to provide an elongated sheath of substantially biocompatible material having a curved contour corresponding to the at least part of the curved surface of the elongated member; and

removing the retaining elements after fixation to provide a curved sheath having a generally C-shaped cross-section.

9. The method of claim 8, the elongated member having a generally cylindrical sidewall portion that extends arcuately along its length between opposite ends thereof.

10. The method of claim 9, the sidewall portion of the elongated member having a radius of curvature extending between the opposite ends thereof that is greater than about forty-five degrees.

11. The method of claim 8, the retaining elements including sutures that connect the opposed side edges of the sheet.

12. The method of claim 8, the elongated member extending arcuately between spaced apart ends of the elongated member according to a radius of curvature, such that after fixation the sheath extends arcuately between the ends of the sheet according to the radius of curvature.

13. The method of claim 8, wherein the biological tissue material comprises animal pericardium.

14. An elongated sheath produced according to claim 8.

15. A method of making an implantable sheath having a curved contour, comprising:

providing a sheet of tissue, the sheet having ends spaced apart from each other by elongated side edges;

placing the sheet into engagement with a surface of an elongated member, the surface being curved along at least a portion of a long axis that extends between ends of the elongated member, the elongated member extending arcuately between spaced apart ends of the elongated member according to a radius of curvature;

applying retaining elements to hold the sheet relative to the elongated member such that at least a substantial portion of the sheet engages the at least part of the curved surface of the elongated member during fixation;

fixing the sheet in a fixation solution while the sheet engages at least part of the curved surface of the elongated member so that at least part of the sheet assumes a contour defined by the at least part of the curved surface of the elongated member engaged by the sheet; and

separating the sheet relative from the elongated member to provide an elongated sheath of substantially biocompatible material having a curved contour corresponding to the at least part of the curved surface of the elongated member; and

removing the retaining elements together with a strip of tissue from the sheet located adjacent and coextensive to at least one of the side edges of the sheet to form an elongated sheath having a curved contour that extends arcuately between opposite ends thereof and having generally C-shaped cross section.