Implantable prosthetic device having integral patency diagnostic indicia

• US 5,320,100 A
• Filed: 03/12/1993
• Issued: 06/14/1994
• Est. Priority Date: 09/16/1991
• Status: Expired due to Fees

• Current Assignee: Atrium Medical Corporation (Getinge AB)
• Original Assignee: Atrium Medical Corporation (Getinge AB)
• Inventors: Martakos, Paul, Karwoski, Theodore, Herweck, Steve A.
• Primary Examiner(s): Isabella, David
• Assistant Examiner(s): NOT, DEFINED
• Application Number:
  US08/029,982
• Time in Patent Office: 459 Days
• Field of Search: 623/1, 623/11, 623/12, 128/654, 128/899
• US Class Current: 600/431
• CPC Class Codes: A61F 2/06 Blood vessels
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body
• CPC Class Codes: A61L 2300/44 Radioisotopes, radionuclides
• CPC Class Codes: A61L 27/16 obtained by reactions only involving carbon-to-carbon unsaturated bonds
• CPC Class Codes: A61L 27/54 Biologically active materials, e.g. therapeutic substances A61L27/227 takes precedence
• CPC Class Codes: A61L 27/56 Porous materials, e.g. foams or sponges
• CPC Class Codes: C08L 27/18 Homopolymers or copolymers or tetrafluoroethene
• CPC Class Codes: Y10S 623/912 Method or apparatus for measuring or testing prosthetic

Abstract

An implantable prosthetic device comprises a remotely detectible component disposed in the body forming the device for allowing the device to be detected by x-ray, ultrasonic, or MRI imaging. By disposing at least two remotely detectible components in the body of the device, the effective flow diameter provided by the device can be monitored. A method for monitoring a patient having a damaged or dysfunctional vascular pathway includes the steps of implanting in the patient the disclosed prosthetic device and monitoring the patency of the device by x-ray, ultrasonic, MRI, or other form of remote imaging.

Claims

1. An implantable prosthetic device for connection to a fluid flow pathway of a patient, the device comprising:

a biocompatible microporous wall that surrounds an interior space which constitutes a lumen that extends along a longitudinal axis and is adapted for accommodating fluid flow therethrough, and

plural remotely detectable components formed integrally within secondary lumina in said wall to move therewith said secondary lumens formed by extrusion and each extending in a line parallel to said longitudinal axis, such that said plural remotely detectable components are remotely detectable as liens that move relative to each other with pulsatile motion of the wall as blood flows through the lumen for indicating patency of the lumen.

2. A device as set forth in claim 1, wherein said remotely detectable components are formed of a material comprising a radiopaque polymer.

3. A device as set forth in claim 1, wherein said remotely detectable components comprise metallic strips.

4. A device as set forth in claim 1, wherein said remotely detectable components are formed of a material which has a density different from that of said tubular body.

5. A device as set forth in claim 1, wherein said wall consists of polytetrafluoroethylene.

6. A device as set forth in claim 5, wherein said polytetrafluoroethylene is selected from the group consisting of stretched polytetrafluoroethylene, expanded polytetrafluoroethylene, and stretched and expanded polytetrafluoroethylene.

7. A device as set forth in claim 1, wherein said wall consists of a material including copolymers.

8. A device as set forth in claim 1, wherein said remotely detectable components are arranged substantially equidistant about the circumference of said lumen.

9. A device according to claim 1, wherein the secondary lumina include at least two lumina with a length coextensive with the primary lumen, forming remotely detectable lines that indicate openness at all portions along the primary lumen.

10. A device according to claim 8, wherein the secondary lumina include at least two lumina with a length coextensive with the primary lumen, forming remotely detectable lines that indicate openness at all portions along the primary lumen.

11. An implantable prosthetic device comprising a biocompatible microporous tubular body defining

a primary lumen enclosed by said body and adapted for accommodating fluid flow therethrough, and

at least two secondary lumina formed integrally extending by extrusing with said body in respective lines parallel to the primary lumen and arranged equidistant about said primary lumen, and a remotely detectable material disposed in each of said secondary lumina for forming remotely detectable lines that move relative to each other as the body moves for visibly indicating patency of the primary lumen.

12. A device as set forth in claim 11, wherein said remotely detectible material is a radiopaque polymer.

13. A device as set forth in claim 11, wherein said remotely detectible material is a metallic strip.

14. A device as set forth in claim 11, wherein said remotely detectible material has a density different from that of said tubular body.

15. A device as set forth in claim 11, wherein said tubular body consists of polytetrafluoroethylene.

16. A device as set forth in claim 15, wherein said polytetrafluoroethylene is selected from the group consisting of stretched polytetrafluoroethylene, expanded polytetrafluoroethylene, and stretched and expanded polytetrafluoroethylene.

17. A device as set forth in claim 11, wherein said tubular body consist of a material including a copolymer.

18. A device according to claim 11, wherein the secondary lumina include at least two lumina with a length coextensive with the primary lumen, forming remotely detectable lines that indicate openness at all portions along the primary lumen.

19. A method for monitoring the position of patency of a vascular graft in a patient, the method comprising the steps of

a. providing a vascular graft comprising a biocompatible microporous tubular body defining a primary lumen extending along an axis and at least two secondary lumina formed integrally each extending with said body in a line parallel to said axis and containing remotely detectable material, the secondary lumina moving relative to each other with motion of the body,

b. implanting the vascular graft in the patent under conditions sufficient to establish blood flow through the primary lumen, and

c. monitoring the graft by a remote imaging technique to image the remotely detectable material as lines, motion of the lies indicating patency of the primary lumen.

20. A method as set forth in claim 19, wherein said remote imaging technique is selected form the group consisting of x-ray imaging, ultrasonic imaging and magnetic resonance imaging.

21. A method as set forth in claim 19, wherein the step of monitoring the vascular graft is carried out substantially simultaneously with the step of implanting the vascular graft.

22. A method as set forth in claim 19, wherein the step of monitoring the vascular graft is carried out after the step of implanting the vascular graft.