Implantable pressure transducer system optimized for anchoring and positioning

• US 7,509,169 B2
• Filed: 04/27/2005
• Issued: 03/24/2009
• Est. Priority Date: 09/26/2002
• Status: Expired due to Fees

• Current Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Original Assignee: Pacesetter Incorporated (Abbott Laboratories)
• Inventors: Mann, Brian M., Eigler, Neal L., Whiting, James S., Hafelfinger, Werner
• Primary Examiner(s): MANUEL, GEORGE C
• Application Number:
  US11/115,991
• Publication Number:
  US 20050288722A1
• Time in Patent Office: 1,427 Days
• Field of Search: 607126-128, 607130-132, 607/119, 607/120, 607/122, 600/375
• US Class Current: 607/27
• CPC Class Codes: A61B 17/3468 for implanting or removing devices, e.g. prostheses, implants, seeds, wires devices for implanting seeds A61M37/0069
• CPC Class Codes: A61B 5/0215 by means inserted into the body catheters A61M25/00
• CPC Class Codes: A61B 5/6869 Heart
• CPC Class Codes: A61B 5/6882 Anchoring means
• CPC Class Codes: A61B 8/12 in body cavities or body tracts, e.g. by using catheters catheters per se A61M25/00
• CPC Class Codes: A61M 2025/0233 specifically adapted for attaching to a body wall by means which are on both sides of the wall, e.g. for attaching to an abdominal wall
• CPC Class Codes: A61M 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• CPC Class Codes: A61M 31/002 Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time artificial gland structures or devices A61F2/022; intra-uterine contraceptive devices A61F6/14; tampons for introducing into the vagina A61F13/20, A61L15/00; suppositories or bougies for intra-vaginal or intra-uterine application A61K9/02; physical forms of medicinal preparations for sustained or differential drug release A61K9/20, A61K9/50
• CPC Class Codes: A61N 1/3629 in combination with non-electric therapy
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

This invention relates generally to systems and methods for optimizing the performance and minimizing complications related to implanted sensors, such as pressure sensors, for the purposes of detecting, diagnosing and treating cardiovascular disease in a medical patient. Systems and methods for anchoring implanted sensors to various body structures is also provided.

Claims

1. A physiological lead system, comprising:

an elongate member having a proximal end and a distal end;

a lead located generally at the distal end of said elongate member; and

a distal anchor assembly engaged to said elongate member, said distal anchor assembly comprising at least one protruding member, said distal anchor assembly configured to change shape from a first state to a second state,

wherein the at least one protruding member is substantially parallel to a longitudinal axis of the distal anchor assembly in the first state and bent at an angle with respect to the longitudinal axis of the distal anchor assembly in the second state, and

wherein the at least one protruding member further comprises at least one non-linear tissue ingrowth path.

2. The physiological lead system of claim 1, wherein at least one said non-linear tissue ingrowth path comprises a hole in said protruding member.

3. The physiological lead system of claim 2, wherein said protruding member comprises a plurality of holes of similar diameters.

4. The physiological lead system of claim 2, wherein said protruding member comprises a plurality of holes of different diameters.

5. The physiological lead system of claim 1, wherein at least one said non-linear tissue ingrowth path comprises a curved slit or variable width slit.

6. The physiological lead system of claim 1, wherein at least one said tissue ingrowth path comprises a groove.

7. The physiological lead system of claim 1, wherein at least one said protruding member has a curved or angled configuration.

8. The physiological lead system of claim 7, wherein the curved or angled configuration of said protruding member is curved or angled radially about a longitudinal axis of said elongate member.

9. The physiological lead system of claim 7, wherein the curved or angled configuration of said protruding member lies in the same plane as a perpendicular radial cross section of said elongate member.

10. The physiological lead system of claim 1, wherein said distal anchor assembly is engaged to said elongate member at a separation distance from said lead such that said lead is substantially unaffected by forces acting on said distal anchor assembly.

11. The physiological lead system of claim 1, further comprising a proximal anchor assembly engaged to said elongate member generally between said distal anchor assembly and the proximal end of said elongate member.

12. The physiological lead system of claim 1, wherein at least a portion of said distal anchor assembly has a biocompatible coating.

13. The physiological lead system of claim 12, wherein at least a portion of one said tissue ingrowth path has a biocompatible coating.

14. The physiological lead system of claim 12, wherein said biocompatible coating is bio-stable.

15. The physiological lead system of claim 12, wherein said biocompatible coating is bio-erodable.

16. The physiological lead system of claim 12, wherein said biocompatible coating is resistant to thrombus formation.

17. The physiological lead system of claim 12, wherein said biocompatible coating is configured to control tissue ingrowth.

18. The physiological lead system of claim 12, wherein said biocompatible coating is resistant to corrosion.

19. The physiological lead system of claim 12, wherein said biocompatible coating is configured to reduce formation of fibrous tissue.

20. The physiological lead system of claim 19, wherein said biocompatible coating does not prevent growth of endothelial tissue.

21. The physiological lead system of claim 1, further comprising a drug-eluting system.

22. The physiological lead system of claim 21, wherein said drug-eluting system comprises a coating on said distal anchor assembly.

23. The physiological lead system of claim 22, wherein the drug-eluting coating is configured for a particular elution rate or elution duration.

24. The physiological lead system of claim 22, wherein said drug-eluting system further comprises a drug for controlling neointimal thickness.

25. The physiological lead system of claim 1, wherein said elongate member further comprises a removable stylet and a stylet lumen.

26. The physiological lead system of claim 1, wherein at least one ingrowth path is non-linear when the distal anchor assembly is in the second state.

27. The physiological lead system of claim 1, wherein the at least one protruding member comprises a substantially planar tissue-contacting surface.

28. The physiological lead system of claim 1, wherein the at least one protruding member comprises a tissue-contacting surface configured to contact a tissue surface at an implant site without puncturing the tissue surface.

29. A physiological lead system, comprising:

an elongate member having a proximal end and a distal end;

a lead located generally at the distal end of said elongate member; and

means for anchoring said lead system to an organ wall in a body, wherein said means for anchoring is configured to change shape from a first state to a second state, and wherein the means for anchoring comprises at least one non-linear tissue ingrowth path.

30. A physiological sensor system, comprising:

an elongate member having a proximal end and a distal end;

a sensor located generally at the distal end of said elongate member; and

a distal anchor assembly engaged to said elongate member, said distal anchor assembly comprising at least one protruding member, said distal anchor assembly configured to change shape from a first state to an second state,

wherein the at least one protruding member is substantially parallel to a longitudinal axis of the distal anchor assembly in the first state and bent at an angle with respect to the longitudinal axis of the distal anchor assembly in the second state, and

wherein the at least one protruding member further comprises at least one non-linear tissue ingrowth path.