# US 2022/0032071 A1 · Coronary sinus conduction system pacing and delivery

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- Number: US 2022/0032071 A1
- Document ID: US20220032071A1
- Status: Published application
- Kind: A1
- Application number: 17/360,643
- Filed: 2021-06-28
- Published: 2022-02-03
- Earliest claimed: 2020-07-31
- Assignees: Medtronic, Inc.
- Applicants: Medtronic, Inc.
- Inventors: Vinod Sharma
- Web page: https://patentgrep.com/patent/US20220032071A1

## CPC

- A61N 1/3706: {Pacemaker parameters (stimulation threshold A61N1/371)}
- A61N 1/0565: {Electrode heads}
- A61N 1/0573: {chacterised by means penetrating the heart tissue, e.g. helix needle or hook}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- A61N 2001/058: {Fixing tools}
- A61N 2001/0585: {Coronary sinus electrodes}
- 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)

## Abstract

An implantable medical system includes an implantable catheter advanceable into a coronary sinus of a patient's heart. A guide element and an implantable lead receivable in the side lumen is advanceable through an angled opening of the catheter to be deflected laterally away from the catheter at the deflection angle to position the at least one testing electrode or at least one pacing electrode, respectively, in a myocardium of the patient's heart when the distal portion of the catheter is positioned in the coronary sinus.

## Claims

### Claim 1

An implantable medical system comprising:
an implantable catheter advanceable into a coronary sinus of a patient's heart, the catheter comprising a sheath body extending between a proximal portion and a distal portion, the catheter comprising a side lumen and an angled opening proximal to the distal portion in fluid communication with the side lumen, wherein the side lumen and the angled opening define a deflection angle;
a guide element receivable in the side lumen, the guide element extending from a proximal portion to a distal portion, wherein the distal portion includes at least one testing electrode, wherein the guide element is advanceable through the angled opening to be deflected laterally away from the catheter at the deflection angle to position the at least one testing electrode in a myocardium of the patient's heart when the distal portion of the catheter is positioned in the coronary sinus; and
an implantable lead receivable in the side lumen, the lead comprising a lead body extending from a proximal portion to a distal portion, wherein the implantable lead comprises an anchoring element disposed along the lead body and at least one pacing electrode disposed along the distal portion, wherein the lead is advanceable through the angled opening to be deflected laterally away from the catheter at the deflection angle to implant the at least one pacing electrode in the myocardium to pace a conduction system of the patient's heart.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the anchoring element is positioned proximal to the at least one pacing electrode.

### Claim 3 (depends on 1)

The system according to claim 1, wherein the anchoring element is integrally formed with the at least one pacing electrode.

### Claim 4 (depends on 1)

The system according to claim 1, wherein the anchoring element comprises a helical structure configured to engage the coronary sinus vessel wall of the patient.

### Claim 5 (depends on 1)

The system according to claim 1, wherein the lead is a bipolar lead comprising two or more pacing electrodes including the at least one second electrode.

### Claim 6 (depends on 1)

The system according to claim 1, wherein the sheath body comprises a tapered tip portion distal to the angled opening.

### Claim 7 (depends on 6)

The system according to claim 6, wherein the sheath body comprises an ultrasound visible tip portion extending distal to the tapered tip portion.

### Claim 8 (depends on 1)

The system according to claim 1, wherein the guide element and the lead are separately advanceable or retractable relative to one another.

### Claim 9 (depends on 1)

The system according to claim 1, wherein the guide element is advanceable through a lead lumen of the lead to a potential implant location.

### Claim 10

A delivery system for an implantable medical device, the system comprising:
an implantable catheter advanceable into a coronary sinus of a patient's heart, the catheter comprising a sheath body extending between a proximal portion and a distal portion, the catheter comprising a side lumen and an angled opening proximal to the distal portion in fluid communication with the side lumen, wherein the side lumen and the angled opening define a deflection angle;
a guide element receivable in the side lumen, the guide element extending from a proximal portion to a distal portion, wherein the distal portion includes at least one testing electrode, wherein the guide element is advanceable through the angled opening to be deflected laterally away from the catheter at the deflection angle to position the at least one testing electrode in a myocardium of the patient's heart when the distal portion of the catheter is positioned in the coronary sinus;
an implantable lead receivable in the side lumen, the lead comprising a lead body extending from a proximal portion to a distal portion, wherein the implantable lead comprises an anchoring element disposed along the lead body and at least one pacing electrode disposed along the distal portion, wherein the lead is advanceable through the angled opening to be deflected laterally away from the catheter at the deflection angle to implant the at least one pacing electrode in the myocardium to pace a conduction system of the patient's heart; and
an electrical analyzer operably coupled to the at least one testing electrode, the electrical analyzer configured to provide pacing pulses to a potential implant location when the at least one testing electrode is positioned in the myocardium of the patient's heart and the distal portion of the catheter is positioned in the coronary sinus.

### Claim 11 (depends on 10)

The system according to claim 10, further comprising an electrode apparatus operably coupled to the patient, the electrode apparatus configured to monitor QRS duration in response pacing the potential implant location.

### Claim 12 (depends on 10)

The system according to claim 10, comprising an implantable controller operably coupled to the at least one second electrode, the anchoring element, or both, the implantable controller configured to provide pacing pulses to a selected implant location.

### Claim 13 (depends on 10)

The system according to claim 10, further comprising an interventricular ultrasound (IVUS) system configured to monitor the position of the distal portion of the catheter.

### Claim 14

A method comprising:
advancing a catheter into a coronary sinus of a patient's heart, the catheter comprising a sheath body extending between a proximal portion and a distal portion, the catheter comprising a side lumen and an angled opening proximal to the distal portion in fluid communication with the side lumen;
orienting the angled opening toward a wall of the coronary sinus proximate to a conduction system of the patient's heart;
advancing a guide element including at least one testing electrode through the side lumen and the angled opening, the guide element extending from a proximal portion to a distal portion, wherein the angled opening is configured to deflect the guide element laterally away from the catheter to position the at least one testing electrode in a myocardium of the patient's heart;
pacing one or more potential implant locations using the at least one testing electrode positioned in the myocardium;
monitoring QRS duration corresponding to each potential implant location in response to pacing the one or more potential implant locations; and
implanting at least one pacing electrode of an implantable lead at a selected implant location of the potential implant locations based on a corresponding QRS duration below a duration threshold.

### Claim 15 (depends on 14)

The method according to claim 14, further comprising retracting the guiding element from the side lumen after implanting the at least one pacing electrode.

### Claim 16 (depends on 14)

The method according to claim 14, further comprising determining the selected implant location based on a corresponding narrowest QRS duration.

### Claim 17 (depends on 14)

The method according to claim 14, wherein monitoring QRS duration comprises monitoring the QRS duration as the guide element is advanced to one or more depths in the myocardium.

### Claim 18 (depends on 14)

The method according to claim 14, further comprising:
advancing the guide element deeper into the myocardium until a wider QRS duration is detected at a particular potential implant location;
retracting the guide element proximally from the particular potential implant location; and
determining the selected implant location proximal to the potential implant location associated with a narrower QRS duration than detected at the particular potential implant location.

### Claim 19 (depends on 14)

The method according to claim 14, further comprising:
monitoring pacing threshold corresponding to each potential implant location in response to pacing the one or more potential implant locations using the at least one testing electrode; and
in response to identifying more than one of the potential implant locations having a corresponding QRS duration below the duration threshold, determining the selected implant location based on a corresponding pacing threshold below a below a target value.

### Claim 20 (depends on 14)

The method according to claim 14, further comprising monitoring advancement of the catheter using an intraventricular ultrasound (IVUS) system.
