Implantable medical electrical lead with light-activated adhesive fixation

• US 6,718,212 B2
• Filed: 10/12/2001
• Issued: 04/06/2004
• Est. Priority Date: 10/12/2001
• Status: Active Grant

• Current Assignee: Medtronic Incorporated (Medtronic Plc)
• Original Assignee: Andrew J Parry, Medtronic Incorporated (Medtronic Plc)
• Inventors: Williams, Terrell M., Parry, Andrew J.
• Primary Examiner(s): Schaetzle, Kennedy
• Application Number:
  US09/977,101
• Publication Number:
  US 20030074041A1
• Time in Patent Office: 907 Days
• Field of Search: 607/129, 607/130, 607/119, 600/375, 600/386, 600/391
• US Class Current: 607/130
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 2001/0578 having means for removal or extraction

Abstract

Medical electrical leads adapted to be implanted within the body, and particularly such leads having at least one distal electrode affixed at a site of a body organ, particularly the epicardium of the heart, employing a light-activated adhesive fixation, and methods and systems for accessing the site, applying the distal electrode to the site, and activating the light-activated adhesive. The lead is preferably implanted by performing a thoracoscopy of the thorax of the patient to visualize the site of the epicardium through a thoracoscope and to provide a pathway to the site of the epicardium. While viewing the site of the epicardium through the thoracoscope, the electrode head is inserted through the provided pathway to apply the plate against the site of the epicardium, and the light-activated adhesive is exposed to a predetermined bandwidth of light to adhere the plate to the epicardium. An elongated introduction tool is selectively operable to grasp and release the electrode head and to conduct light of the predetermined bandwidth to the electrode plate. The introduction tool preferably has an opaque sidewall enclosing a plurality of optical fibers distributed around the circumference of and within the sidewall of the introduction tool to extend lengthwise to the introduction tool distal end, whereby the plurality of optical fiber distal ends are capable of emitting light of the predetermined frequency in a substantially cylindrical emission pattern. The light-activated adhesive comprises one of a light-activated acrylic or cyanoacrylate adhesive that is activated by ultraviolet light that is activated by ultraviolet light. The lead body is formed with a strain relief proximal to the electrode head for absorbing strain placed on the lead body from being transmitted to the electrode head at the lead body distal end and absorbing the strain induced in the lead body by movement of the body organ, e.g., the contraction and expansion of the heart.

Claims

1. A medical electrical lead adapted to conduct electrical stimulation from an implantable or external electrical stimulator to a site of the epicardium and to conduct electrical signals of the heart from the site to the implantable or external electrical stimulator comprising:

an elongated lead body extending from a lead body proximal end to a lead body distal end;

an electrode head formed at the lead body distal end having a plate adapted to bear against the epicardium, the electrode head supporting a first distal electrode; and

a fixation mechanism comprising a light-activated adhesive disposed upon the plate that is sensitive to a predetermined bandwidth of light to adhere the plate to the epicardium while the plate is applied against the epicardium.

2. The medical electrical lead of claim 1, wherein the light-activated adhesive comprises one of a light-activated acrylic or cyanoacrylate adhesive that is activated by ultraviolet light.

3. The medical electrical lead of claim 2, wherein the plate of the electrode head is formed of a light transmissive fabric mesh upon which the light activated adhesive is disposed, whereby the ultraviolet light is transmitted through the light transmissive fabric mesh.

4. The medical electrical lead of claim 3, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

5. The medical electrical lead of claim 1, wherein the plate of the electrode head is formed of a light transmissive fabric mesh upon which the light activated adhesive is disposed, whereby light of the predetermined bandwidth is transmitted through the light transmissive fabric mesh.

6. The medical electrical lead of claim 5, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

7. The medical electrical lead of claim 1, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

8. The medical electrical lead of claim 1, wherein the elongated lead body is formed with a strain relief proximal to the electrode head for absorbing strain placed on the lead body at or adjacent to the lead body proximal end from being transmitted to the electrode head at the lead body distal end and absorbing the strain induced in the lead body by the contraction and expansion of the heart.

9. The medical electrical lead of claim 8, wherein strain relief comprises one or more loop of the lead body formed in a common plane that is parallel with the plane of the mesh plate, so that the loops lie against the epicardium adjacent to and extending from the site of attachment of the electrode head to the epicardium.

10. A method of implanting a medical electrical lead to conduct electrical stimulation from an implantable or external electrical stimulator to a site of the epicardium and to conduct electrical signals of the heart from the site to the implantable or external electrical stimulator comprising:

providing a medical electrical lead having;

an elongated lead body extending from a lead body proximal end to a lead body distal end;

an electrode head formed at the lead body distal end having a plate adapted to bear against the epicardium, the electrode head supporting a first distal electrode; and

a fixation mechanism comprising a light-activated adhesive disposed upon the plate;

forming a incision through the thorax of the patient to access the site of the epicardium;

inserting the electrode head through the incision to apply the plate against the site of the epicardium; and

exposing the light-activated adhesive to a predetermined bandwidth of light transmitted through the incision to adhere the plate to the epicardium.

11. The method of claim 10, wherein:

the inserting step further comprises;

providing an elongated introduction tool having proximal and distal tool ends that is selectively operable to grasp and release the electrode head and conducts light of the predetermined bandwidth to the electrode plate;

grasping the electrode head with the introduction tool at the introduction tool distal end; and

manipulating the introduction tool at or adjacent the introduction tool proximal end to inserting the introduction tool and electrode head through the incision and apply the plate against the site of the epicardium; and

the exposing step comprises conducting light of the predetermined bandwidth through the introduction tool to the electrode plate.

12. The method of claim 11, wherein the plate of the electrode head is formed of a light transmissive fabric mesh upon which the light activated adhesive is disposed, whereby light of the predetermined bandwidth is transmitted through the light transmissive fabric mesh.

13. The method of claim 12, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

14. The method of claim 11, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

15. The method of claim 11, wherein the elongated lead body is formed with a strain relief proximal to the electrode head for absorbing strain placed on the lead body at or adjacent to the lead body proximal end from being transmitted to the electrode head at the lead body distal end and absorbing the strain induced in the lead body by the contraction and expansion of the heart.

16. The method of claim 15, wherein strain relief comprises one or more loop of the lead body formed in a common plane that is parallel with the plane of the mesh plate, so that the loops lie against the epicardium adjacent to and extending from the site of attachment of the electrode head to the epicardium.

17. The method of claim 10, wherein the light-activated adhesive comprises one of a light-activated acrylic or cyanoacrylate adhesive that is activated by ultraviolet light.

18. The method of claim 17, wherein the plate of the electrode head is formed of a light transmissive fabric mesh upon which the light activated adhesive is disposed, whereby the ultraviolet light is transmitted through the light transmissive fabric mesh.

19. The method of claim 18, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

20. A method of implanting a medical electrical lead to conduct electrical stimulation from an implantable or external electrical stimulator to a site of the epicardium and to conduct electrical signals of the heart from the site to the implantable or external electrical stimulator comprising:

providing a medical electrical lead having;

an elongated lead body extending from a lead body proximal end to a lead body distal end;

an electrode head formed at the lead body distal end having a plate adapted to bear against the epicardium, the electrode head supporting a first distal electrode; and

a fixation mechanism comprising a light-activated adhesive disposed upon the plate;

performing a thoracoscopy of the thorax of the patient to visualize the site of the epicardium through a thoracoscope and to provide a pathway to the site of the epicardium; and

while viewing the site of the epicardium through the thoracoscope,

inserting the electrode head through the provided pathway to apply the plate against the site of the epicardium; and

exposing the light-activated adhesive to a predetermined bandwidth of light to adhere the plate to the epicardium.

21. The method of claim 20, wherein:

the inserting step further comprises;

providing an elongated introduction tool having proximal and distal tool ends that is selectively operable to grasp and release the electrode head and conducts light of the predetermined bandwidth to the electrode plate;

grasping the electrode head with the introduction tool at the introduction tool distal end; and

manipulating the introduction tool at or adjacent the introduction tool proximal end to inserting the introduction tool and electrode head through the pathway and apply the plate against the site of the epicardium; and

the exposing step comprises conducting light of the predetermined bandwidth through the introduction tool to the electrode plate.

22. The method of claim 21, wherein the plate of the electrode head is formed of a light transmissive fabric mesh upon which the light activated adhesive is disposed, whereby light of the predetermined bandwidth is transmitted through the light transmissive fabric mesh.

23. The method of claim 22, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

24. The method of claim 21, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

25. The method of claim 21, wherein the elongated lead body is formed with a strain relief proximal to the electrode head for absorbing strain placed on the lead body at or adjacent to the lead body proximal end from being transmitted to the electrode head at the lead body distal end and absorbing the strain induced in the lead body by the contraction and expansion of the heart.

26. The method of claim 25, wherein strain relief comprises one or more loop of the lead body formed in a common plane that is parallel with the plane of the mesh plate, so that the loops lie against the epicardium adjacent to and extending from the site of attachment of the electrode head to the epicardium.

27. The method of claim 20, wherein the light-activated adhesive comprises one of a light-activated acrylic or cyanoacrylate adhesive that is activated by ultraviolet light.

28. The method of claim 27, wherein the plate of the electrode head is formed of a light transmissive fabric mesh upon which the light activated adhesive is disposed, whereby the ultraviolet light is transmitted through the light transmissive fabric mesh.

29. The method of claim 28, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

30. The method of claim 20, wherein:

the step of performing a thoracoscopy further comprises;

forming first and second pathways through a patient'"'"'s thoracic wall to access the site of the epicardium; and

inserting a thoracoscope through the first pathway surgically made through the patient'"'"'s thoracic wall to visualize the site of the epicardium; and

the inserting step comprises inserting the electrode head through the second pathway to apply the plate against the site of the epicardium.

31. A system for implanting a medical electrical lead to conduct electrical stimulation from an implantable or external electrical stimulator to a site of the epicardium and to conduct electrical signals of the heart from the site to the implantable or external electrical stimulator comprising:

A medical electrical lead having;

an elongated lead body extending from a lead body proximal end to a lead body distal end;

an electrode head formed at the lead body distal end having a plate adapted to bear against the epicardium, the electrode head supporting a first distal electrode; and

a fixation mechanism comprising a light-activated adhesive disposed upon the plate;

means for forming first and second pathways through a patient'"'"'s thoracic wall to access the site of the epicardium;

a thoracoscope adapted to be inserted through the first pathway surgically made through the patient'"'"'s thoracic wall to visualize the site of the epicardium; and

means for inserting the electrode head through the second pathway to apply the plate against the site of the epicardium and to expose the light-activated adhesive to a predetermined bandwidth of light to adhere the plate to the epicardium.

32. The method of claim 31, wherein the inserting means further comprises an elongated introduction tool having proximal and distal tool ends that is selectively operable to grasp and release the electrode head and to conduct light of the predetermined bandwidth to the electrode plate and further comprising:

means for grasping the electrode head with the introduction tool at the introduction tool distal end to enable manipulation of the introduction tool at or adjacent the introduction tool proximal end to insert the introduction tool and electrode head through the second pathway and apply the plate against the site of the epicardium;

light conducting means for conducting light of the predetermined bandwidth through the introduction tool to the electrode plate; and

means for releasing the electrode head from the grasping means.

33. The system of claim 32, wherein the introduction tool has an opaque sidewall, and the light conducting means comprises a plurality of optical fibers having optical fiber proximal and distal ends distributed around the circumference of and within the sidewall of the introduction tool to extend lengthwise to the introduction tool distal end, whereby the plurality of optical fiber distal ends are capable of emitting light of the predetermined frequency in a substantially cylindrical emission pattern from the introduction tool distal end.

34. The system of claim 31, wherein the inserting means further comprises an elongated introduction tool that is selectively operable to grasp and release the electrode head and to conduct light of the predetermined bandwidth to the electrode plate and further comprising:

an elongated tubular handle extending from handle proximal and distal ends and having a handle lumen extending from the handle proximal end to the handle distal end, a notched distal end that is shaped to frictionally grip the electrode head, and an elongated slot extending to the handle proximal end that loosely receives the lead body;

an elongated ejection rod extending between an ejection rod proximal end to an ejection rod distal end fitted into the handle lumen so that the ejection rod distal end can be advanced through the handle lumen against the electrode head to release the electrode head from the notched distal end when adhesion is accomplished; and

an outer tubular sheath extending from a sheath proximal end to a sheath distal end and formed with a sheath lumen through which the tubular handle and the rod within the handle lumen are inserted to retain the lead body within the elongated slot, the outer tubular sheath further enclosing a light conductor having a light conductor proximal end and a light conductor distal end that conducts light of the predetermined bandwidth through the outer tubular sheath to the sheath distal end, whereby the light is emitted in a light beam from the light conductor distal end upon the light-activated adhesive.

35. The system of claim 34, wherein the tubular sheath has an opaque cylindrical sidewall, and the light conductor comprises a plurality of optical fibers having optical fiber proximal and distal ends distributed around the circumference of and within the sidewall to extend lengthwise to the sheath distal end, whereby the light conductor distal end comprises a like plurality of optical fiber distal ends capable of emitting light of the predetermined frequency in a substantially cylindrical emission pattern from the tubular sheath distal end.

36. The system of claim 31, wherein the light-activated adhesive comprises one of a light-activated acrylic or cyanoacrylate adhesive that is activated by ultraviolet light.

37. The system of claim 36, wherein the plate of the electrode head is formed of a light transmissive fabric mesh upon which the light activated adhesive is disposed, whereby the ultraviolet light is transmitted through the light transmissive fabric mesh.

38. The system of claim 37, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

39. The system of claim 31, wherein the plate of the electrode head is formed of a light transmissive fabric mesh upon which the light activated adhesive is disposed, whereby light of the predetermined bandwidth is transmitted through the light transmissive fabric mesh.

40. The system of claim 39, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

41. The system of claim 31, wherein the light activated adhesive is disposed in a band substantially surrounding said first distal electrode.

42. The system of claim 31, wherein the elongated lead body is formed with a strain relief proximal to the electrode head for absorbing strain placed on the lead body at or adjacent to the lead body proximal end from being transmitted to the electrode head at the lead body distal end and absorbing the strain induced in the lead body by the contraction and expansion of the heart.

43. The system of claim 42, wherein strain relief comprises one or more loop of the lead body formed in a common plane that is parallel with the plane of the mesh plate, so that the loops lie against the epicardium adjacent to and extending from the site of attachment of the electrode head to the epicardium.