# US 11,110,286 B2 · Delivery system for an implantable medical device

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- Number: US 11,110,286 B2
- Document ID: US11110286B2
- Status: Granted
- Kind: B2
- Application number: 16/384,214
- Filed: 2019-04-15
- Published: 2019-08-08
- Granted: 2021-09-07
- Earliest claimed: 2014-06-10
- Assignees: BIOTRONIK SE & Co. KG
- Applicants: BIOTRONIK SE & Co. KG
- Inventors: Dirk Muessig; Larry Stotts
- Web page: https://patentgrep.com/patent/US11110286B2

## CPC

- A61N 1/3756: {Casings with electrodes thereon, e.g. leadless stimulators}
- A61B 17/3468: {for implanting or removing devices, e.g. prostheses, implants, seeds, wires (devices for implanting seeds A61M37/0069)}
- A61N 1/37205: {Microstimulators, e.g. implantable through a cannula}
- A61N 1/37512: {Pacemakers}
- A61N 1/37518: {Anchoring of the implants, e.g. fixation}
- A61M 25/0668: {splittable, tear apart}
- A61M 2025/0675: {Introducing-sheath slitters}
- A61N 1/362: Heart stimulators (heart defibrillators A61N1/39)
- 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

A delivery tool for an implantable medical device to be introduced into a human or animal body, in particular, an implantable leadless pacemaker, the delivery tool having an outer sheath and an inner sheath, wherein the inner sheath is configured to be retractable into a lumen of the outer sheath, wherein a distal side of the inner sheath is configured to provide regions which are reversibly collapsible and non-collapsible in diameter, wherein a non-collapsible region is arranged at the distal end of the inner sheath. A system including a delivery tool and an implantable medical device is also provided.

## Claims

### Claim 1

A system comprising:
a delivery tool; and
an implantable medical device, the implantable medical device having a distal end and an opposing proximal end with a fastener provided for interaction with a coupling element of the delivery tool,
wherein the delivery tool comprises an outer sheath and an inner sheath, wherein the inner sheath is configured to be retractable into a lumen of the outer sheath, wherein a distal portion of the inner sheath is configured to provide regions which are reversibly collapsible and non-collapsible in diameter, wherein a non-collapsible region is arranged at the distal end of the inner sheath, and wherein an outer diameter of the non-collapsible region is greater than an inner diameter of the outer sheath such that the non-collapsible region remains outside of the outer sheath with the inner sheath in a retracted position and the collapsible region collapsed within the lumen of the outer sheath, and wherein the distal end of the inner sheath is configured to receive the implantable medical device.

### Claim 2 (depends on 1)

The system according to claim 1, wherein the non-collapsible region comprises a soft material configured to protect tissue while applying pressure when placing the implantable medical device.

### Claim 3 (depends on 1)

The system according to claim 1, wherein the collapsible region comprises a metal structure having a memory effect, wherein the metal structure elongates and reduces its diameter by applying a pulling force and which unfolds the metal structure into its non-collapsed form when pushed out of the inner sheath.

### Claim 4 (depends on 3)

The system according to claim 3, wherein the metal structure comprises Nitinol.

### Claim 5 (depends on 1)

The system according to claim 1, wherein the collapsible region comprises longitudinal sections of differing thicknesses and/or durability.

### Claim 6 (depends on 5)

The system according to claim 5, wherein in a circumferential direction of the inner sheath sections of thicker material are spaced apart by sections of thinner material.

### Claim 7 (depends on 5)

The system according to claim 5, wherein the sections comprise polymer material.

### Claim 8 (depends on 1)

The system according to claim 1, wherein the collapsible and non-collapsible regions form a protective cup covering the implantable medical device during an implant procedure.