Drug releasing anastomosis devices and methods for treating anastomotic sites

• US 7,108,701 B2
• Filed: 10/21/2002
• Issued: 09/19/2006
• Est. Priority Date: 09/28/2001
• Status: Expired due to Term

• Current Assignee: Wyeth (Pfizer Inc.)
• Original Assignee: Ethicon Incorporated (Johnson & Johnson)
• Inventors: Weedock, Kevin, Evens, Carl J.
• Primary Examiner(s): Jackson, Gary
• Application Number:
  US10/274,782
• Publication Number:
  US 20030065346A1
• Time in Patent Office: 1,429 Days
• Field of Search: 606153-155
• US Class Current: 606/153
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0469 Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/0644 penetrating the tissue, deformable to closed position
• CPC Class Codes: A61B 17/068 Surgical staplers , e.g. containing multiple staples or clampsstaplers containing only one staple A61B17/10; magazines or containers for staples A61B17/105; for performing anastomosis A61B17/115; staplers in general B25C5/00
• CPC Class Codes: A61B 17/0684 having a forming anvil staying above the tissue during stapling
• CPC Class Codes: A61B 17/0686 having a forming anvil staying below the tissue during stapling
• CPC Class Codes: A61B 17/11 for performing anastomosis; Buttons for anastomosis
• CPC Class Codes: A61B 17/115 Staplers for performing anastomosis in a single operation
• CPC Class Codes: A61B 2017/00508 using laser
• CPC Class Codes: A61B 2017/00517 using laser
• CPC Class Codes: A61B 2017/06028 by means of a cylindrical longitudinal blind bore machined at the suture-receiving end of the needle, e.g. opposite to needle tip
• CPC Class Codes: A61B 2017/0641 having at least three legs as part of one single body
• CPC Class Codes: A61B 2017/0648 threaded, e.g. tacks with a screw thread
• CPC Class Codes: A61B 2017/081 Tissue approximator A61B2017/1103, A61B17/8866 take precedence
• CPC Class Codes: A61B 2017/1107 for blood vessels
• CPC Class Codes: A61B 2017/1135 End-to-side connections, e.g. T- or Y-connections Y-shaped blood vessel prostheses A61F2002/065
• CPC Class Codes: A61F 2/064 with special features to facilitate anastomotic coupling anastomosis of natural blood vessels A61B17/11
• CPC Class Codes: A61F 2/07 Stent-grafts
• CPC Class Codes: A61F 2/89 the wire-like elements comprising two or more adjacent rings flexibly connected by separate members
• CPC Class Codes: A61F 2/91 : made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 : with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/958 : Inflatable balloons for placing stents or stent-grafts
• CPC Class Codes: A61F 2002/065 : Y-shaped blood vessels
• CPC Class Codes: A61F 2002/067 : modular
• CPC Class Codes: A61F 2002/075 : the stent being loosely attached to the graft material, e.g. by stitching
• CPC Class Codes: A61F 2230/0013 : Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
• CPC Class Codes: A61F 2230/005 : Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2250/0067 : Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61F 2310/0097 : Coating or prosthesis-covering structure made of pharmaceutical products, e.g. antibiotics
• CPC Class Codes: A61L 2300/41 : Anti-inflammatory agents, e.g. NSAIDs
• CPC Class Codes: A61L 2300/416 : Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
• CPC Class Codes: A61L 2300/42 : Anti-thrombotic agents, anticoagulants, anti-platelet agents
• CPC Class Codes: A61L 2300/45 : Mixtures of two or more drugs, e.g. synergistic mixtures
• CPC Class Codes: A61L 2300/606 : Coatings
• CPC Class Codes: A61L 27/34 : Macromolecular materials
• CPC Class Codes: A61L 27/54 : Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/0057 : Catheters delivering medicament other than through a conventional lumen, e.g. porous walls or hydrogel coatings
• CPC Class Codes: A61M 25/0045 : multi-layered, e.g. coated coating materials A61L29/08
• CPC Class Codes: A61P 37/06 : Immunosuppressants, e.g. drugs for graft rejection
• CPC Class Codes: A61P 7/02 : Antithrombotic agents; Anticoagulants; Platelet aggregation inhibitors
• CPC Class Codes: C08L 27/12 : containing fluorine atoms

Abstract

Medical devices, and in particular implantable medical devices, may be coated to minimize or substantially eliminate a biological organism'"'"'s reaction to the introduction of the medical device to the organism. The medical devices may be coated with any number of biocompatible materials. Therapeutic drugs, agents or compounds may be mixed with the biocompatible materials and affixed to at least a portion of the medical device. These therapeutic drugs, agents or compounds may also further reduce a biological organism'"'"'s reaction to the introduction of the medical device to the organism. Various materials and coating methodologies may be utilized to maintain the drugs, agents or compounds on the medical device until delivered and positioned.

Claims

1. An apparatus for joining substantially tubular organs in a living organism, comprising:

a graft vessel;

an anastomosis device for connecting the graft vessel to a target vessel such that the two vessels are in fluid communication, the graft vessel having a first end and a second end, the first end being everted to form a cuff; and

at least one agent in therapeutic dosages affixed to the cuff for the treatment of reactions by the living organism caused by the device or the implantation thereof, the cuff comprising a biocompatible coating affixed thereto, the biocompatible coating includes a polymeric matrix comprising a polyfluoro copolymer comprising polymerized residue of a first moiety selected from the group consisting of vinylidenefluoride and tetrafluoroethylene, and polymerized residue of a second moiety other than the first moiety and which is copolymerized with the first moiety, thereby producing the polyfluoro copolymer, wherein the relative amounts of the polymerized residue of the first moiety and the polymerized residue of the second moiety are effective to produce the biocompatible coating with properties effective for use in coating implantable medical devices when the coated medical device is subjected to a predetermined maximum temperature, and a solvent in which the polyfluoro copolymer is substantially soluble.

2. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the anastomosis device comprises a flange and a plurality of fastener members.

3. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the anastomosis device comprises a surgical clip for sealingly connecting the graft vessel to the target vessel.

4. The apparatus for joining substantially tubular organs in a living organism according to claim 3, wherein the surgical clip comprises a holding device which penetrates the graft and target vessel walls and sealingly joins them when crimped.

5. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the graft vessel comprises an autograft.

6. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the graft vessel comprises a homograft.

7. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the graft vessel comprises a xenograft.

8. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the graft vessel comprises a synthetic material.

9. The apparatus for joining substantially tubular organs in a living organism according to claim 8, wherein the synthetic material comprises a polymer.

10. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the cuff contains the at least one agent in therapeutic dosages.

11. The apparatus for joining substantially tubular organs in a living organism according to claim 10, wherein the cuff facilitates elution of the at least one agent in therapeutic dosage amounts.

12. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the polyfluoro copolymer comprises from about 50 to about 92 weight percent of the polymerized residue of the first moiety copolymerized with from about 50 to about 8 weight percent of the polymerized residue of the second moiety.

13. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein said polyfluoro copolymer comprises from about 50 to about 85 weight percent of the polymerized residue of vinylidenefluoride copolymerized with from about 50 to about 15 weight percent of the polymerized residue of the second moiety.

14. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein said copolymer comprises from about 55 to about 65 weight percent of the polymerized residue of the vinylidenefluoride copolymerized with from about 45 to about 35 weight percent of the polymerized residue of the second moiety.

15. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the second moiety is selected from the group consisting of hexafluoropropylene, tetrafluoroethylene, vinylidenefluoride, 1-hydropentafluoropropylene, perfluoro (methyl vinyl ether), chlorotrifluoroethylene, pentafluoropropene, trifluoroethylene, hexafluoroacetone and hexafluoroisobutylene.

16. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the second moiety is hexafluoropropylene.

17. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the at least one agent comprises an anti-proliferative.

18. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the at least one agent comprises an anti-inflammatory.

19. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the at least one agent comprises an anti-coagulant.

20. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the at least one agent comprises rapamycin.

21. The apparatus for joining substantially tubular organs in a living organism according to claim 1, wherein the at least one agent comprises heparin.