Endocardiac lead having an active fastening means

• US 5,259,394 A
• Filed: 12/23/1991
• Issued: 11/09/1993
• Est. Priority Date: 12/27/1990
• Status: Expired due to Term

• Current Assignee: Ela Medical S.A. (LivaNova Plc)
• Original Assignee: Ela Medical S.A. (LivaNova Plc)
• Inventors: Bens, Jean-Luc
• Primary Examiner(s): Kamm, William E.
• Assistant Examiner(s): Getzow, Scott M.
• Application Number:
  US07/812,696
• Time in Patent Office: 687 Days
• Field of Search: 128/784, 128/785, 128/786, 128/642
• US Class Current: 607/127
• CPC Class Codes: A61N 1/0573 chacterised by means penetrating the heart tissue, e.g. helix needle or hook

Abstract

An endocardiac lead of the type including a conductive spiral winding 2 placed inside a sheath 1 made of a flexible material being insensitive to body fluids. This spiral winding 2 is electrically connected to an electrode 3 intended for being brought into contact with the inner wall of the heart. The electrode 3 is hollow and accommodates along its centerline a deformable helix 6 intended for fastening the lead into the heart muscle. The inner diameter of the electrode 3 is smaller than the outer diameter of the undeformed helix 6. The helix 6 presents a sufficient longitudinal elasticity modulus for being retractable inside the electrode 3 with a mechanical deformation, while the helix will substantially recover its initial shape during its extraction out of the electrode and secure the electrode to the tissue. The helix 6 may be made of a nickel-titanium based alloy. The inner wall of the electrode 3 presents a deformation having the shape of a notch 13 against which the helix 6 will abut during its extraction.

Claims

1. An endocardiac lead of the type comprising a sheath (1), an electrode (3), a helix (6), a conductive spiral winding (2) placed inside the sheath (1) made of a flexible insulating material which is insensitive to body fluids, the spiral winding (2) being electrically connected to the electrode (3) intended for being brought into contact with the inner wall of the heart, said electrode (3) being hollow and receiving along its centerline the helix (6) for fastening the lead into the heart muscle, characterized in that the internal diameter of the electrode (3) is smaller than the external diameter of the helix (6), and in that the helix (6) presents a sufficient modulus of longitudinal elasticity for being retractable within the electrode (3) with a mechanical deformation, and in that the helix (6) will substantially recover its initial shape when being extracted out of the electrode.

2. A lead according to claim 1, characterized in that the helix (6) is made of a metallic alloy.

3. A lead according to claim 2, characterized in that the alloy is a nickel-titanium based alloy.

4. A lead according to claim 1, characterized in that the helix (6) is covered, at least over its distal portion, with an electrically insulating coating.

5. A lead according to claim 4, characterized in that the coating consists of a fluorocarbon based material.

6. A lead according to claim 1, wherein the extraction of the helix (6) out of the electrode (3) is effected through a rotation controlled by a driving means (9, 12) inserted inside the lead, characterized in that the inner wall of the electrode (3) presents a deformation having the shape of a notch (13) against which the helix (6) will rest during its extraction.

7. A lead according to claim 2 wherein the extraction of the helix (6) out of the electrode (3) is effected through a rotation controlled by a driving means (9, 12) inserted inside the lead, characterized in that the inner wall of the electrode (3) presents a deformation having the shape of a notch (13) against which the helix (6) Will rest during its extraction.

8. A lead according to claim 2, characterized in that the helix (6) is covered, at least over its distal portion, with an electrically insulating coating.

9. A lead according to claim 3, characterized in that the helix (6) is covered, at least over its distal portion, with an electrically insulating coating.

10. Apparatus for securing a body to tissue comprising:

a first body having a distal end for contacting tissue and an elongated passageway having an inner dimension;

a deformable fastener means for penetrating tissue and securing the first body to the tissue comprising a second body having a distal tip, a proximal driving end, and an undeformed configuration including an outer dimension larger than the passageway inner dimension; and

a mount means for securing the second body in a deformed condition inside the elongated passageway for rotational movement therealong so that the second body can be rotated and advanced and recover its undeformed shape as it is advanced out of the passageway.

11. The apparatus of claim 10 wherein the second body further comprises a material having a Young'"'"'s modulus in the range of from 9,000 to 10,000 daN/mm.².

12. The apparatus of claim 10 wherein the second body further comprises an alloy including nickel and titanium.

13. The apparatus of claim 10 wherein the second body further comprises a deformable helix having an axis and wherein the mount means further comprises:

a protrusion extending from the passageway interior for engaging the deformable helix; and

a driving end piece connected to the proximal driving end for rotating the deformable helix about the axis thereby to move the deformable helix axially along the passageway relative to the protrusion.

14. The apparatus of claim 13 wherein the driving end piece further comprises an aperture for receiving a stylet tip.

15. The apparatus of claim 13 wherein the first body distal end further comprises a shaped opening for receiving the deformable helix distal tip in the passageway.

16. The apparatus of claim 13 wherein the deformable helix is made of a material characterized by an elongation at breaking point in the range of 10 to 20%, an elastic elongation in the range of 6 to 8%;

a Young'"'"'s modulus in the range of 9,000 to 10,000 daN/mm² ;

an elastic limit in the range of 40 to 50 daN/mm² ;

a Poisson'"'"'s modulus in the range of 0.30 to 0.35; and

a breakdown point in the range of 80 to 90 daN/mm².

17. An endocardiac lead comprising:

a sheath having a distal end;

a member secured to the distal end of and interior to the sheath including a distal face for contacting tissue and an axial passageway having an inner diameter;

a deformable helix having an undeformed shape including an outer diameter that is greater than the inner diameter of the member passageway, an axis of rotation, a distal tip for penetrating tissue, and a proximal end for rotating the helix;

a mount means secured inside the sheath for receiving the deformable helix inside the member; and

a driving end piece connected to the helix proximal end for rotating the helix relative to the member so that the helix can be deformed as it is retracted in the member and restored to its natural shape as it is extended out the member.

18. The apparatus of claim 17 further comprising:

an electrical conductor interior to the sheath;

a coating on the helix for electrically insulating the helix from the tissue;

wherein the member further comprises an electrode in electrical contact with the electrical conductor.

19. The apparatus of claim 18 wherein the electrical conductor is spirally wound interior to the sheath.

20. The apparatus of claim 19 wherein the helix is made of a metallic alloy having a Young'"'"'s modulus of in the range of from 9,000 to 10,000 daN/mm².

21. The apparatus of claim 17 wherein the member further comprises a protrusion in the passageway for engaging the helix so that the helix moves relative to the protrusion as the helix is rotated.

22. The apparatus of claim 21 wherein the distal end of the sheath has an outer diameter of less than 2.0 mm, the helix has an undeformed outer diameter in the range of 1.2 to 1.4 mm, and the member inner diameter is in the range of 0.6 to 0.7 mm.

23. The apparatus of claim 17 wherein the member further comprises a shaped opening for receiving the deformable helix distal tip in the passageway so that the helix tip is deformed less than the helix when retracted in the member.

24. The apparatus of claim 23 wherein the material is a metallic alloy.

25. The apparatus of claim 24 wherein the metallic alloy is a nickel-titanium alloy.

26. The apparatus of claim 17 wherein the helix is made of a material characterized by an elongation at breaking point in the range of 10 to 20%, an elastic elongation in the range of 6 to 8%;

a Young'"'"'s modulus in the range of 9,000 to 10,000 daN/mm² ;

an elastic limit in the range of 40 to 50 daN/mm² ;

a Poisson'"'"'s modulus in the range of 0.30 to 0.35; and

a breakdown point in the range of 80 to 90 daN/mm².

27. The apparatus of claim 17 wherein the distal end of the sheath has an outer diameter of less than 2.0 mm, the helix has an undeformed outer diameter in the range of 1.2 to 1.4 mm, and the member inner diameter is in the range of 0.6 to 0.7 mm.

28. A method for securing a body having a tissue contacting surface to tissue comprising:

providing the body with an interior passageway having an inner dimension;

providing a deformable fastener having a tip for penetrating tissue and an undeformed shape including an outer dimension that is greater than the passageway inner dimension;

inserting the deformable fastener into the passageway so that it is deformed;

placing the tissue contacting surface of the body proximate to the tissue to which the body is to be secured; and

rotating the fastener relative to the body so that it extends out the passageway and penetrates into the tissue and as it extends out it recovers its undeformed shape.

29. The method of claim 28 wherein providing the deformable fastener further comprises providing an deformable helix, the method further comprising providing the passageway with a protrusion for engaging the helix inside the passageway so that the helix moves relative to the protrusion during rotation of the helix.

30. The method of claim 29 wherein rotating the helix further comprises:

securing a driving end piece to the end of the helix opposite the tip;

providing the driving end piece with a receptacle;

inserting a stylet having a tip into the body so that the stylet tip cooperates with the driving end piece receptacle; and

rotating the stylet.

31. The method of claim 29 wherein providing the deformable helix further comprises forming the helix from a material characterized by an elongation at breaking point in the range of 10 to 20%, accepted elongation in the range of 6 to 8%;

a Young'"'"'s modulus in the range of 9,000 to 10,000 daN/mm² ;

an elastic limit in the range of 40 to 50 daN/mm² ;

a Poisson'"'"'s modulus in the range of 0.30 to 0.35; and

a breakdown point in the range of 80 to 90 daN/mm².

32. The method of claim 28 wherein the fastener is made of a material having a Young'"'"'s modulus in the range of from 9,000 to 10,000 daN/mm².

33. The method of claim 28 wherein the fastener is made of a metallic alloy.

34. The method of claim 33 wherein the fastener is made of an alloy of nickel and titanium.

35. The method of claim 28 wherein providing the deformable fastener further comprises forming a fastener from a material characterized by an elongation at breaking point in the range of 10 to 20%, an elastic elongation in the range of 6 to 8%;

a Young'"'"'s modulus in the range of 9,000 to 10,000 daN/mm² ;

an elastic limit in the range of 40 to 50 daN/mm² ;

a Poisson'"'"'s modulus in the range of 0.30 to 0.35; and

a breakdown point in the range of 80 to 90 daN/mm².