# US 11,077,299 B2 · Implantation of an active medical device

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- Number: US 11,077,299 B2
- Document ID: US11077299B2
- Status: Granted
- Kind: B2
- Application number: 15/913,369
- Filed: 2018-03-06
- Published: 2018-09-13
- Granted: 2021-08-03
- Earliest claimed: 2017-03-07
- Assignees: Cardiac Pacemakers, Inc.
- Applicants: Cardiac Pacemakers, Inc.
- Inventors: Christopher Alan Fuhs; Andrew L. De Kock; G. Shantanu Reddy; Peter Hall; James K. Cawthra, Jr.; Daniel J. Foster
- Web page: https://patentgrep.com/patent/US11077299B2

## CPC

- A61N 1/056: {Transvascular endocardial electrode systems}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61M 25/0662: {Guide tubes}
- A61N 2001/0578: {having means for removal or extraction}
- A61N: ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY (measurement of bioelectric currents A61B; surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body A61B18/00; anaesthetic apparatus in general A61M; incandescent lamps H01K; infrared radiators for heating H05B)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61M: DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY (introducing media into or onto the bodies of animals A61D7/00; means for inserting tampons A61F13/26; devices for administering food or medicines orally A61J; containers for collecting, storing or administering blood or medical fluids A61J1/05); DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY (surgery A61B; chemical aspects of surgical articles A61L); DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR {(Electrotherapy, e.g. producing anaesthesia by the use of alternating or intermittent currents A61N1/36021)}

## Abstract

Implantation of a cardiac stimulus system using the ITV. Superior, intercostal, and inferior access methods are discussed and disclosed. Superior access may be performed using the brachiocephalic vein to access the ITV, with access to the brachiocephalic vein achieved using subclavian vein, using standard visualization techniques. A positioning mechanism may be advanced to the ITV, a location of the positioning mechanism may then be obtained, and an external access may then be established. Inferior external access may be accomplished inferior to the lower rib margin via the superior epigastric or musculophrenic vein. Intercostal external access may be accomplished via an intercostal vein between two ribs. A lead may then be attached to the positioning mechanism and drawn into the ITV.

## Claims

### Claim 1

A method of implanting a lead for use in a cardiac stimulus system in a patient, the method comprising:
establishing access to a brachiocephalic vein of the patient;
advancing a positioning mechanism from the brachiocephalic vein to and into an internal thoracic vein (ITV), wherein the positioning mechanism has a proximal end and a distal end, and the advancing step comprises advancing the distal end of the positioning mechanism into the ITV;
obtaining a location of the positioning mechanism in the ITV;
establishing an external access to the positioning mechanism at a position either in the ITV, the musculophrenic vein, or in the superior epigastric vein;
attaching the lead to the positioning mechanism; and
drawing the lead into the ITV by pulling on the positioning mechanism.

### Claim 2 (depends on 1)

The method of claim 1 wherein the lead has a proximal end configured for attachment to an implantable pulse generator, and a distal end having one or more electrodes associated therewith; the step of attaching the lead to the positioning mechanism comprises attaching the distal end of the lead to the distal end of the positioning mechanism, and the step of drawing the lead into the ITV is performed by pulling on the proximal end of the positioning mechanism.

### Claim 3 (depends on 1)

The method of claim 1 wherein the lead has a proximal end configured for attachment to an implantable pulse generator, and a distal end having one or more electrodes associated therewith; the step of attaching the lead to the positioning mechanism comprises attaching the proximal end of the lead to the proximal end of the positioning mechanism, and the step of drawing the lead into the ITV is performed by pulling on the distal end of the positioning mechanism at the location of the external access.

### Claim 4 (depends on 1)

The method of claim 1 wherein the positioning mechanism is a guidewire.

### Claim 5 (depends on 1)

The method of claim 1 wherein the distal end of the positioning mechanism has a shape controllable from the proximal end of the positioning mechanism.

### Claim 6 (depends on 1)

The method of claim 1 wherein the distal end of the positioning mechanism includes an eyelet or suture hole.

### Claim 7 (depends on 1)

The method of claim 1 wherein the lead has a distal end having a suture hole, and attaching the lead to the positing mechanism comprises using a suture to removeably secure the suture hole of the lead to the positioning mechanism.

### Claim 8 (depends on 1)

The method of claim 1 wherein the distal end of the positioning mechanism includes a hook.

### Claim 9 (depends on 1)

The method of claim 1 wherein establishing access to the brachiocephalic vein comprises accessing the subclavian vein and advancing the positioning mechanism from the access to the subclavian vein to the brachiocephalic vein.

### Claim 10 (depends on 1)

The method of claim 1 wherein the step of obtaining a location of the positioning mechanism in the ITV further comprises obtaining a visualization of the positioning mechanism.

### Claim 11

A method of implanting a lead for use in a cardiac stimulus system in a patient, the method comprising:
establishing access to a brachiocephalic vein of the patient;
advancing a positioning mechanism from the brachiocephalic vein to and into an internal thoracic vein (ITV), wherein the positioning mechanism has a proximal end and a distal end, and the advancing step comprises advancing the distal end of the positioning mechanism into the ITV;
advancing the distal end of the positioning mechanism from the ITV to and into a tributary vein of the ITV;
obtaining a visualization of the positioning mechanism in at least the tributary vein of the ITV;
establishing an external access to the positioning mechanism at a position in the tributary vein of the ITV;
attaching the lead to the positioning mechanism; and
drawing the lead into at least the ITV by pulling on the positioning mechanism.

### Claim 12 (depends on 11)

The method of claim 11 wherein the lead has a proximal end configured for attachment to an implantable pulse generator, and a distal end having one or more electrodes associated therewith; the step of attaching the lead to the positioning mechanism comprises attaching the distal end of the lead to the distal end of the positioning mechanism, and the step of drawing the lead into the ITV is performed by pulling on the proximal end of the positioning mechanism.

### Claim 13 (depends on 11)

The method of claim 11 wherein the lead has a proximal end configured for attachment to an implantable pulse generator, and a distal end having one or more electrodes associated therewith; the step of attaching the lead to the positioning mechanism comprises attaching the proximal end of the lead to the proximal end of the positioning mechanism, and the step of drawing the lead into the ITV is performed by pulling on the distal end of the positioning mechanism at the location of the external access.

### Claim 14 (depends on 11)

The method of claim 11 wherein the positioning mechanism is a guidewire.

### Claim 15 (depends on 11)

The method of claim 11 wherein the distal end of the positioning mechanism has a shape controllable from the proximal end of the positioning mechanism.

### Claim 16 (depends on 11)

The method of claim 11 wherein the distal end of the positioning mechanism includes an eyelet or suture hole.

### Claim 17 (depends on 11)

The method of claim 11 wherein the lead has a distal end having a suture hole, and attaching the lead to the positing mechanism comprises using a suture to removeably secure the suture hole of the lead to the positioning mechanism.

### Claim 18 (depends on 11)

The method of claim 11 further comprising detaching the lead from the positioning mechanism using electromagnetic (EM) energy to break a bond or link between the lead and the positioning mechanism.
