Subcutaneous lead with tined fixation

• US 7,493,175 B2
• Filed: 12/18/2003
• Issued: 02/17/2009
• Est. Priority Date: 04/11/2003
• Status: Active Grant

• Current Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Original Assignee: Cardiac Pacemakers Incorporated (Boston Scientific Corporation)
• Inventors: Shiroff, Jason Alan, Cates, Adam W., Heil, Ron, Lindstrom, Curtis Charles
• Primary Examiner(s): Manuel; George
• Application Number:
  US10/739,877
• Publication Number:
  US 20040230279A1
• Time in Patent Office: 1,888 Days
• Field of Search: 607/126, 607/119, 607/5, 607/8, 607/127, 607/122, 600/119, 600/508
• US Class Current: 607/126
• CPC Class Codes: A61B 17/3203 Fluid jet cutting instruments
• CPC Class Codes: A61B 17/3415 for introducing tubes or catheters, e.g. gastrostomy tubes, drain catheters A61B17/3417 takes precedence; body piercing catheter guide needles A61M25/06
• CPC Class Codes: A61B 17/3417 Details of tips or shafts, e.g. grooves, expandable, bendable; Multiple coaxial sliding cannulas, e.g. for dilating syringe needles A61M5/32; dilators A61M29/00
• CPC Class Codes: A61B 2017/00243 cardiac
• CPC Class Codes: A61B 2017/00247 Making holes in the wall of the heart, e.g. laser Myocardial revascularization
• CPC Class Codes: A61B 2017/320044 Blunt dissectors
• CPC Class Codes: A61B 2017/320084 Irrigation sleeves
• CPC Class Codes: A61B 2018/00392 Transmyocardial revascularisation
• CPC Class Codes: A61B 2090/3945 Active visible markers, e.g. light emitting diodes
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61B 2217/007 with irrigation system
• CPC Class Codes: A61B 90/30 Devices for illuminating a surgical field, the devices having an interrelation with other surgical devices or with a surgical procedure
• CPC Class Codes: A61N 1/05 for implantation or insertion into the body, e.g. heart electrode A61N1/06 takes precedence
• CPC Class Codes: A61N 1/056 Transvascular endocardial electrode systems
• CPC Class Codes: A61N 1/0568 with drug delivery
• CPC Class Codes: A61N 1/0587 Epicardial electrode systems; Endocardial electrodes piercing the pericardium
• CPC Class Codes: A61N 1/36542 controlled by body motion, e.g. acceleration
• CPC Class Codes: A61N 1/36585 controlled by two or more physical parameters
• CPC Class Codes: A61N 1/3956 Implantable devices for applying electric shocks to the heart, e.g. for cardioversion

Abstract

Implantable subcutaneous devices and methods employ a lead and/or electrode for cardiac monitoring and/or intervention. The devices and methods may employ one or more fixation elements including, for example, tines, tines with barbs, spring-loaded tines, flexible or collapsible tines, and other tined fixation mechanisms configured to passively secure one or both of the electrode or body of the lead in subcutaneous non-intrathoracic tissue. A method of implanting subcutaneous leads according to the present invention involves providing a lead comprising a lead body, an electrode, and one or more fixation elements, and passively securing one or both of the lead body and the electrode to subcutaneous non-intrathoracic tissue at one or more fixation sites using the fixation elements. The method may involve use of a delivery device, such as a sheath, for lead delivery to a subcutaneous non-intrathoracic implant site.

Claims

1. An implantable lead configured for placement within a tunnel formed in subcutaneous non-intrathoracic tissue, comprising:

a lead body;

a cardiac electrode supported by the lead body, the cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel; and

a plurality of fixation elements disposed longitudinally along at least an electrically insulative portion of the lead body in a spaced relationship, the fixation elements configured to passively secure one or both of the cardiac electrode and the lead body in subcutaneous non-intrathoracic tissue at a plurality of longitudinally spaced fixation sites of the tunnel, the plurality of fixation elements comprising;

a first set of curved tines, each curved tine of the first set comprising a first end attached to the lead body on the electrically insulative portion and a free end opposite the first end, each curved tine of the first set biased out of plane with respect to a longitudinal axis of the lead body in a first orientation to curve around some of the circumference of the lead body such that the free end points in a clockwise direction with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the clockwise direction; and

a second set of curved tines, each curved tine of the second set comprising a first end attached to the leady body on the electrically insulative portion and a free end opposite the first end, each curved tine of the second set biased out of plane with respect to the longitudinal axis of the lead body in a second orientation to curve around some of the circumference of the lead body such that the free end points in a counterclockwise direction with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the counterclockwise direction.

2. The lead according to claim 1, wherein the tines comprise barbs.

3. The lead according to claim 1, wherein the fixation elements comprise tines formed from a metal.

4. The lead according to claim 1, wherein the fixation elements comprise tines formed from a material having a spring memory, the tines situated on the lead to permit axial displacement of the lead in a distal direction and to be set in the subcutaneous non-intrathoracic tissue in response to axial displacement of the lead in a proximal direction.

5. The lead according to claim 1, wherein the fixation elements comprise collapsible tines.

6. The lead according to claim 1, wherein the fixation elements comprise a plurality of continuous wires, each tine of the first set and each tine of the second set are formed by the plurality of continuous wires, and each continuous wire forms one of the tines of the first set and one of the tines of the second set.

7. An implantable lead system configured for placement within a tunnel formed in subcutaneous non-intrathoracic tissue, comprising:

a lead comprising a lead body and a cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel, the lead configured for placement within the tunnel;

a plurality of fixation elements comprising a plurality of tines disposed longitudinally along at least an electrically insulative portion of the lead body in a spaced relationship, the plurality of tines comprising;

at least one first type of tine having a first end attached to the electrically insulative portion of the lead body and a free end distal with respect to the first end, each of the first type of tine orientated along the lead body to extend from the lead body in a distal direction to passively secure one or both of the cardiac electrode and the lead body in subcutaneous non-intrathoracic tissue of the tunnel and resist axial displacement of the lead in the distal direction; and

at least one second type of tine having a first end attached to the electrically insulative portion of the lead body and a free end proximal with respect to the first end, each of the second type of tine orientated along the lead body to extend from the lead body in a proximal direction to passively secure one or both of the cardiac electrode and the lead body in subcutaneous non-intrathoracic tissue of the tunnel and resist axial displacement of the lead in the proximal direction; and

a delivery apparatus configured to introduce the lead to a desired location within the tunnel, the delivery apparatus comprising a sheath, a lumen of the sheath dimensioned to at least partially collapse the tines while permitting axial displacement of the lead within the lumen, wherein removal of the sheath from the lead body allows the tines to engage the subcutaneous non-intrathoracic tissue.

8. The lead system according to claim 7, wherein at least one type of the first and second type of tines are curved tines that curve around some of the lead body circumference such that the free end points in a clockwise or counterclockwise direction with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the clockwise or counterclockwise direction.

9. The lead system according to claim 7, wherein the sheath comprises a longitudinal pre-stress line arrangement to facilitate sheath separation during retraction of the sheath from the patient.

10. A method of stabilizing a lead within a tunnel formed in subcutaneous non-intrathoracic tissue, comprising:

providing a lead comprising a lead body, a cardiac electrode, and a plurality of fixation elements comprising a plurality of tines disposed longitudinally along at least an electrically insulative portion of the lead body in a spaced relationship, the cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel; and

passively securing one or both of the lead body and the cardiac electrode to subcutaneous non-intrathoracic tissue defining the tunnel at a plurality of longitudinally spaced fixation sites using the fixation elements to resist rotation of the lead body in at least one of clockwise and counter-clockwise directions using a first set of curved tines of the plurality of tines, each curved tine of the first set comprising a first end attached to the lead body on the electrically insulative portion and a free end opposite the first end, each curved tine of the first set biased out of plane with respect to a longitudinal axis of the lead body in a first orientation to curve around some of the lead body circumference such that the free end points in a clockwise or counterclockwise direction with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the clockwise or counterclockwise direction.

11. The method according to claim 10, wherein passively securing one or both of the lead body and the cardiac electrode to subcutaneous non-intrathoracic tissue defining the tunnel further comprises using a second set of curved tines of the plurality of tines, each curved tine of the second set comprising a first end attached to the lead body on the electrically insulative portion and a free end opposite the first end, each curved tine of the second set biased out of plane with respect to the longitudinal axis of the lead body in a second orientation to curve around some of the lead body circumference such that the free end points in a rotational direction opposite that of the first set of curved tines with respect to the circumference of the lead body at which the first end is attached to the lead body to resist rotation of the lead in the rotational direction.

12. The method according to claim 10, wherein passively securing the one or both of the lead body and the cardiac electrode comprises:

modifying, during lead delivery, a position or an orientation of the fixation elements to facilitate axial displacement of the lead in a distal direction into the subcutaneous non-intrathoracic tissue; and

after lead delivery, using the fixation elements to resist axial displacement of the lead in a proximal direction.

13. The method according to claim 10, wherein passively securing the one or both of the lead body and the cardiac electrode comprises:

modifying, during lead delivery, a position or an orientation of the fixation elements to facilitate axial displacement of the lead in a distal direction into the subcutaneous non-intrathoracic tissue; and

after lead delivery, using the fixation elements to resist rotational displacement of the lead in both clockwise and counterclockwise directions.

14. The method according to claim 10, further comprising:

providing a removable sheath having a lumen; and

modifying a position or an orientation of at least some of the fixation elements when the lead is advanced within the lumen.

15. The method according to claim 14, wherein modifying the position or orientation comprises compressing the at least some of the fixation elements when the lead is advanced within the lumen.

16. The method according to claim 14, wherein modifying the position or orientation comprises resiliently displacing the at least some of the fixation elements when the lead is advanced within the lumen.

17. The method according to claim 14, further comprising returning the at least some of the fixation elements to an initial position or orientation when the at least some of the fixation elements are advanced beyond, or retracted from, the lumen of the sheath.

18. An implantable lead configured for placement within a tunnel formed in subcutaneous non-intrathoracic tissue, comprising:

a lead body;

a cardiac electrode supported by the lead body, the cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel; and

means, disposed longitudinally along at least an electrically insulative portion of the lead body in a spaced relationship, for passively fixing one or both of the lead body and cardiac electrode at a plurality of longitudinally spaced fixation sites of the tunnel using a plurality of tines to resist rotation of the lead body in both clockwise and counter-clockwise directions using a first set of curved tines of the plurality of tines curved around some of the circumference of the lead body in a clockwise orientation and a second set of curved tines of the plurality of tines curved around some of the circumference of the lead body in a counterclockwise orientation.

19. The lead according to claim 18, wherein the fixing means comprises means for acutely fixing the one or both of the lead body and cardiac electrode within the subcutaneous non-intrathoracic tissue.

20. The lead according to claim 18, further comprising means for modifying a position or an orientation of the fixing means.

21. The lead according to claim 18, further comprising a sheath, wherein a lumen of the sheath is dimensioned to at least partially collapse the fixing means while permitting axial displacement of the lead body within the lumen.

22. A method of lead delivery, comprising:

introducing a sheath into a tunnel formed in subcutaneous non-intrathoracic tissue;

providing a lead comprising a lead body and a cardiac electrode, the lead body comprising a plurality of tines and the cardiac electrode configured for one or both of sensing cardiac activity and delivering cardiac stimulation energy from a location within the tunnel;

advancing the lead through the sheath and to a location within the tunnel, the sheath at least partially collapsing the plurality of tines;

passively fixing the lead body to subcutaneous non-intrathoracic tissue defining the tunnel at a plurality of longitudinally spaced fixation sites located along at least an electrically insulative portion of the lead body using the plurality of tines distributed at the plurality of fixation sites, the plurality of tines comprising;

at least one first type of tine having a first end attached to the lead body and a free end distal with respect to the first end, each of the first type of tine orientated along the lead body to extend from the lead body in a distal direction to resist axial displacement of the lead in the distal direction; and

at least one second type of tine having a first end attached to the lead body and a free end proximal with respect to the first end, each of the second type of tine orientated along the lead body to extend from the lead body in a proximal direction to resist axial displacement of the lead body in the proximal direction; and

removing the sheath from the patient to allow the plurality of tines to engage subcutaneous non-intrathoracic tissue.

23. The method according to claim 22, wherein removing the sheath comprises longitudinally splitting the sheath when retracting the sheath from the patient.

24. The method according to claim 22, wherein removing the sheath comprises enabling a plurality of fixation elements for passive engagement with the subcutaneous non-intrathoracic tissue.

25. The method according to claim 22, wherein the plurality of tines comprises a plurality of resilient tines.

26. The method according to claim 22, wherein the tines comprise barbs.

27. The method according to claim 22, wherein passively fixing the lead comprises rotating the lead in a first direction to engage a plurality of fixation elements in the subcutaneous non-intrathoracic tissue, further wherein the fixation elements resist disengagement with the subcutaneous non-intrathoracic tissue in response to rotation of the lead in a second direction by use of one or more barbs.

28. The method according to claim 22, wherein passively fixing the lead body comprises longitudinally advancing the lead within the sheath in a distal direction to place the lead in the subcutaneous non-intrathoracic tissue, and pulling the lead in a proximal direction to set at least some of the plurality of tines in the subcutaneous non-intrathoracic tissue after removal of the sheath to resist further proximal movement of the lead body.

29. The method according to claim 22, wherein passively fixing the lead body comprises:

modifying, during lead delivery, a position or an orientation of a passive fixation element to facilitate axial displacement of the lead in a distal direction into the subcutaneous non-intrathoracic tissue; and

after lead delivery, using the passive fixation element to resist one or both of rotation and axial displacement of the lead.