Close vascularization implant material

• US 5,800,529 A
• Filed: 06/07/1995
• Issued: 09/01/1998
• Est. Priority Date: 10/31/1990
• Status: Expired due to Term

• Current Assignee: Baxalta GmbH (Shire plc), Baxalta Incorporated (Shire plc)
• Original Assignee: Baxter International Inc.
• Inventors: Johnson, Robert C., Brauker, James H., Martinson, Laura A., Hill, Ronald S.
• Primary Examiner(s): ISABELLA, DAVID J
• Application Number:
  US08/481,886
• Time in Patent Office: 1,182 Days
• Field of Search: 623/1, 623/11, 623/12, 623/66, 424/11, 424/15, 424/19, 424/45, 424/422, 424/423, 424/424, 604/93, 604/96, 604/890.1, 604/891.1, 604/175, 435/297.1, 435/240.22
• US Class Current: 623/2.38
• CPC Class Codes: A61B 5/14532 for measuring glucose, e.g. by tissue impedance measurement
• CPC Class Codes: A61B 5/413 Monitoring transplanted tissue or organ, e.g. for possible rejection reactions after a transplant
• CPC Class Codes: A61F 2/022 Artificial gland structures using bioreactors hemodialysis A61M1/16; hemofiltration A61M1/34; other extracorporeal blood treatment A61M1/36
• CPC Class Codes: A61L 27/38 containing added animal cells organs or tissue containing native cells A61L27/36
• CPC Class Codes: A61L 27/3839 characterised by the site of application in the body materials for artificial blood vessels A61L27/507; materials for use in artificial skin A61L27/60
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: A61L 29/005 Ingredients of undetermined constitution or reaction products thereof
• CPC Class Codes: A61L 29/085 Macromolecular materials
• CPC Class Codes: A61L 29/146 Porous materials, e.g. foams or sponges
• CPC Class Codes: Y10S 623/92 Method or apparatus for preparing or treating prosthetic
• CPC Class Codes: Y10S 623/925 Natural

Abstract

A device for implantation in a host having a material at an interface between the host and the device, said material having a conformation which results in growth of vascular structures by the host close to the interface.

Claims

1. A device for implantation in a host having a material at an interface between the host and the device, said material having (a) a nominal pore size from about 0.6 to about 20 microns which comprise frames of elongated strands of material that are less than 5 microns in all but the longest dimension wherein said frames define apertures which interconnect to form three-dimensional cavities which permit substantially all host inflammatory cells migrating into the cavities to maintain a rounded morphology;

and (b) a conformation which results in growth of vascular structures by the host close to but not substantially into the interface.

2. The device of claim 1 where the conformation of the material includes three dimensional cavities and irregularities so that host inflammatory cells in contact with the cavities and irregularities can conform to and enter the cavities and irregularities, and do not flatten.

3. The device of claim 1 where said vascular structures grow to within about one cell layer of the material.

4. The device of claim 1 where the material is selected from the group consisting of:

1) Millipore®

Mixed Esters Cellulose, membrane pore size 1.2;

2) Millipore®

Mixed Esters Cellulose, membrane pore size 8.0;

3) Satorious®

, Cellulose Acetate, membrane pore size 0.8;

4) Satorious®

, Cellulose Acetate, membrane pore size 1.2;

4) Satorious®

, Cellulose Acetate, membrane pore size 3.0;

6) Satorious®

, Cellulose Acetate, membrane pore size 5.0;

7) Satorious®

, Cellulose Acetate, membrane pore size 8.0;

8) Gore®

, PTFE/Polyester, membrane pore size 1.0;

9) Gore®

, PTFE/Polyester, membrane pore size 3.0;

10) Gore®

, PTFE/Polyester, membrane pore size 5.0;

11) Gore®

, PTFE/Polyester, membrane pore size 10-15;

12) Gore®

, PTFE/Polypropylene, membrane pore size 3.0;

13) Gelman®

, Versapore®

, membrane pore size 0.8;

14) Gelman®

, Versapore®

, membrane pore size 1.2;

15) Gelman®

, Versapore®

, membrane pore size 3.0; and

16) Gelman®

, Versapore®

, membrane pore size 5.0.

5. The device of claim 1 where the material is impermeable to immune factors.

7. The device of claim 1 where the device is an indwelling catheter.

8. The device of claim 1 where the device is an indwelling sensor and where the material is permeable to an analyte in the host detectable by the sensor.

9. The device of claim 1 where the device is a breast prosthesis.

10. The device of claim 1 where the device is a container for cellular implantation.

11. The device of claim 1 where the material is selected from the group consisting of polyethylene, polypropylene, polytetrafluoroethylene (PTFE), cellulose acetate, cellulose nitrate, polycarbonate, polyester, nylon, polysulfone, mixed esters of cellulose, polyvinylidene difluoride, silicone, and polyacrylonitrile.

6. A device for implantation in a host having a first material at an interface between the host and the device, said first material having (a) a nominal pore size ranging from about 0.6 to about 20 microns which comprise frames of elongated strands of material that are less than 5 microns in all but the longest dimension wherein said frames define apertures which interconnect to form three-dimensional cavities which permit substantially all host inflammatory cells migrating into the cavities to maintain a rounded morphology;

and (b) a conformation which results in growth of vascular structures by the host close to but not substantially into the interface, the device further having a second material underlying the first material, the second material being impermeable to immune factors.