Method and apparatus for implanting a medical device in a coronary sinus
A system for delivery of a leadless pacemaker. The system includes a catheter with an elongate flexible tubular body with a proximal end and a distal end, wherein the distal end of the tubular body includes a delivery cup with an external surface having an inflatable compliant balloon; and a pacing capsule of the leadless pacemaker releasably retained in the delivery cup. The pacing capsule includes an arrangement of tines configured to deploy and pierce a target tissue at a desired pacing capsule implant site in a coronary sinus of a patient. The balloon, when at least partially inflated, is configured to urge the delivery cup against the target tissue during deployment of the pacing capsule.
1. A system for delivery of a leadless pacemaker, the system comprising:
a catheter comprising an elongate flexible tubular body with a proximal end and a distal end, wherein the distal end of the tubular body comprises a delivery cup with an external surface comprising an expandable member; and
a pacing capsule of the leadless pacemaker releasably retained in the delivery cup, wherein the pacing capsule comprises an arrangement of tines comprising memory material configured to deploy and pierce a target tissue at a desired pacing capsule implant site in a coronary sinus of a patient; and
wherein the expandable member, when at least partially expanded, is configured to apply a force against a first wall of the coronary sinus to urge the delivery cup against the target tissue during deployment of the pacing capsule, and the tines on the pacing capsule are configured to deploy laterally from the delivery cup into a second wall of the coronary sinus opposite the first wall thereof when the delivery cup is urged against the target tissue.
2. The system of claim 1 , wherein the expandable member resides on a first side of the delivery cup, and the tines on the pacing capsule are configured to deploy from the delivery cup toward a second side of the delivery cup opposite the first side thereof.
3. The system of claim 1 , wherein the arrangement of tines comprises at least one penetrator tine with a tip configured to pierce and penetrate the target tissue.
4. The system of claim 3 , wherein the arrangement of tines further comprises at least one fixation tine with a tip configured to pierce and penetrate the target tissue.
5. The system of claim 1 , wherein the delivery cup comprises a fluid egress port fluidly connected to the expandable member.
6. The system of claim 1 , wherein the expandable member comprises a balloon that comprises a polymeric material chosen from polyethylene (PE), ethylene vinyl alcohol (EVA), silicone, polyurethane, polyether block amide, and mixtures and combinations thereof.
7. The system of claim 1 , wherein the expandable member extends around a portion of a circumference of an external surface of the delivery cup, and wherein the portion of the circumference is less than the entire circumference.
8. The system of claim 1 , wherein the expandable member extends around a circumference of the external surface of the delivery cup.
9. The system of claim 1 , wherein the delivery cup comprises a plurality of expandable members.
10. The system of claim 1 , wherein the expandable member, when expanded, has a conical shape.
11. The system of claim 1 , wherein the expandable member has a length of about 1 centimeters (cm) to about 10 cm, and an expanded diameter of about 2 cm to about 4 cm.
12. The system of claim 1 , wherein the tubular body of the catheter comprises a polymeric material chosen from polyethylene (PE), nylon, silicone, polyurethane, polyether block amide, and combinations thereof.
13. The system of claim 1 , wherein the tubular body comprises a metal reinforcing material.
14. The system of claim 1 , wherein the tubular body further comprises a braid, a coil, or combinations thereof.
15. The system of claim 1 , wherein the tubular body further comprises a pull wire.
16. A method for implanting a leadless pacemaker in a target cardiac tissue, the method comprising:
inserting into a vasculature of a patient a system for delivery of the leadless pacemaker, the system comprising:
a catheter comprising an elongate flexible tubular body with a distal end having a delivery cup, and wherein an external surface of the delivery cup comprises an expandable member; and
a pacing capsule releasably retained in the delivery cup, wherein the pacing capsule comprises an electrode and an arrangement of tines configured to affix the pacing capsule to the target cardiac tissue, wherein the target cardiac tissue is a wall of a coronary sinus;
maneuvering the delivery cup in the vasculature of the patient to an implant location in the coronary sinus of the patient;
at least partially expanding the expandable member to urge the delivery cup against the target cardiac tissue and anchor the delivery cup at the implant location, wherein the expandable member, when expanded, applies a force against a first wall of the coronary sinus; and
deploying the pacing capsule from the delivery cup so that the tines deploy laterally from the delivery cup and pierce into the target tissue to embed the electrode in the target tissue and affix the pacing capsule in the target tissue at the implant location, wherein the target tissue is a second wall of the coronary sinus opposite the first wall thereof.
17. The method of claim 16 , further comprising:
contracting the expandable member; and
removing the catheter and the delivery cup from the vasculature of the patient.
18. The method of claim 16 , further comprising:
monitoring the location of the delivery cup with an ultrasonic imager to form a sonogram image; and
maneuvering the delivery cup in the vasculature of the patient into the coronary sinus based on the sonogram image.
19. The method of claim 16 , wherein the expandable member overlies at least a portion of the external surface of the delivery cup.
20. The method of claim 16 , wherein the expandable member extends around a circumference of the external surface of the delivery cup.
21. The method of claim 20 , wherein the expandable member extends around a portion of a circumference of the external surface of the delivery cup, and wherein the portion of the circumference is less than the entire circumference.
22. The method of claim 16 , wherein the distal end of the catheter comprises a plurality of expandable members.
23. The method of claim 16 , wherein the expandable member, when expanded, has a conical shape.
24. The method of claim 16 , wherein the expandable member urges the delivery cup against the second wall of the coronary sinus.
25. The method of claim 16 , wherein the expandable member is sufficiently compliant to avoid damage to a wall of the coronary sinus.
26. The method of claim 16 , wherein the expandable member comprises an inflatable balloon.
27. A method for implanting a leadless pacemaker in a target cardiac tissue in a coronary sinus of a patient, the method comprising:
inserting into a vasculature of a patient a system for delivery of the leadless pacemaker, the system comprising:
a catheter comprising an elongate flexible tubular body with a distal end having a delivery cup, and wherein an external surface of the delivery cup comprises an expandable member; and
a pacing capsule releasably retained in the delivery cup, wherein the pacing capsule comprises an electrode and an arrangement of tines configured to affix the pacing capsule to the target cardiac tissue;
maneuvering the delivery cup in the vasculature of the patient to an implant location in a first wall of the coronary sinus of the patient;
expanding the expandable member to urge the delivery cup against the first wall of the coronary sinus opposite a second wall and temporarily affix the delivery cup at the implant location, wherein the expandable member, when expanded, applies a force against the second wall of the coronary sinus; and
deploying the pacing capsule from the delivery cup so that the tines deploy laterally from the delivery cup into the first wall to pierce and embed in the first wall to implant the pacing capsule in the first wall, and the electrode embeds in the first wall.