# US 12,599,747 B2 · Medical device systems and methods including safety release, lumen fluid-providing mechanisms, or both

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- Number: US 12,599,747 B2
- Document ID: US12599747B2
- Status: Granted
- Kind: B2
- Application number: 17/474,149
- Filed: 2021-09-14
- Published: 2021-12-30
- Granted: 2026-04-14
- Earliest claimed: 2015-11-06
- Assignees: Kardium Inc.
- Applicants: Kardium Inc.
- Inventors: Saar Moisa; Julie Elizabeth O'Keane; Ian Garben; Peter Josiah Hawes
- Web page: https://patentgrep.com/patent/US12599747B2

## CPC

- A61M 25/0043: {characterised by structural features}
- A61B 5/0036: {including treatment, e.g., using an implantable medical device, ablating, ventilating}
- A61B 18/1492: {having a flexible, catheter-like structure, e.g. for heart ablation (A61B18/1477 takes precedence)}
- A61M 25/0026: {Multi-lumen catheters with stationary elements (catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175)}
- A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers}
- A61M 25/0147: {with movable mechanical means, e.g. pull wires}
- A61M 25/1018: {Balloon inflating or inflation-control devices}
- A61N 1/056: {Transvascular endocardial electrode systems}
- A61N 1/362: Heart stimulators (heart defibrillators A61N1/39)
- A61B 5/287: Holders for multiple electrodes, e.g. electrode catheters for electrophysiological study [EPS]
- A61B 5/4836: {Diagnosis combined with treatment in closed-loop systems or methods (A61B5/0036 takes precedence)}
- A61B 5/6858: {with a distal basket, e.g. expandable basket}
- A61B 18/02: by cooling, e.g. cryogenic techniques
- A61B 2017/00367: {Details of actuation of instruments, e.g. relations between pushing buttons, or the like, and activation of the tool, working tip, or the like}
- A61B 2018/0016: {Energy applicators arranged in a two- or three dimensional array}
- A61B 2018/00196: {reciprocating lengthwise}
- A61B 2018/00267: {having a basket shaped structure}
- A61B 2018/00351: {Heart}
- A61B 2018/00357: {Endocardium}
- A61B 2018/00577: {Ablation}
- A61B 2018/00791: {Temperature}
- A61B 2018/00839: {Bioelectrical parameters, e.g. ECG, EEG}
- A61B 2018/00875: {Resistance or impedance}
- A61B 2218/002: Irrigation
- A61M 2210/125: Heart
- 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)}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)

## Abstract

A medical device system may include a catheter sheath and a catheter shaft sized for delivery through a lumen of the catheter sheath. The catheter shaft may be coupled to an end effector at or adjacent a distal end of the catheter shaft. The catheter shaft may include a lumen and a control element. The control element may be coupled to the end effector and may reside within the lumen of the catheter shaft. Physical access may be provided to the control element, to allow the control element to be severed to facilitate removal of the end effector from a bodily cavity. The control element may include a lumen and a control cable therein. A liquid entry port may be provided in the lumen of the control element toward a distal end of the control element to allow expedited provision of fluid to a distal portion of the control element.

## Claims

### Claim 1

A method of operating a medical device system, the medical device system comprising an end effector, an enclosure, a catheter shaft extending between the end effector and the enclosure, and a control element operatively coupled to the end effector and at least one actuator to selectively enable a particular end effector function of the end effector, the control element spanning at least a portion of an interior of the catheter shaft between the end effector and a portion of the enclosure, the method comprising:
inhibiting the particular end effector function at least by severing the control element within a region of the control element located within the enclosure,
wherein the particular end effector function is a retracting, deploying, or otherwise manipulating a size or shape of the end effector.

### Claim 2 (depends on 1)

The method of claim 1, wherein the severing comprises severing the control element within the region of the control element while the region of the control element is submerged in a liquid in an interior cavity of the enclosure.

### Claim 3 (depends on 1)

The method of claim 1, wherein the severing comprises severing the control element within the region of the control element while a portion of the control element in an interior cavity of the enclosure is wetted by a liquid.

### Claim 4 (depends on 1)

The method of claim 1, wherein the control element comprises a flexible control cable, the control cable spanning at least the portion of the interior of the catheter shaft between the end effector and the portion of the enclosure.

### Claim 5 (depends on 4)

The method of claim 4, wherein, in a state of the medical device system, the control cable includes tension by way of at least the operative coupling of the control element to the end effector and the at least one actuator, and wherein the severing releases the tension in the control cable.

### Claim 6 (depends on 4)

The method of claim 4, wherein the severing comprises severing a portion of the control cable while the portion of the control cable is submerged in a liquid in an interior cavity of the enclosure.

### Claim 7 (depends on 1)

The method of claim 1, wherein the control element comprises a control cable and an elongate member, the elongate member comprising a first end, a second end, and an elongated portion extending between the first end and the second end, the elongate member providing at least a control cable lumen extending between the first end and the second end, the control cable lumen including the control cable therein, each of the control cable lumen and the control cable spanning at least the portion of the interior of the catheter shaft between the end effector and the portion of the enclosure.

### Claim 8 (depends on 7)

The method of claim 7, wherein, in a state of the medical device system, the control cable includes tension by way of at least the operative coupling of the control element to the end effector and the at least one actuator, and wherein the severing releases the tension in the control cable.

### Claim 9 (depends on 7)

The method of claim 7, wherein the severing comprises severing a portion of the control cable while the portion of the control cable is submerged in a liquid in an interior cavity of the enclosure.

### Claim 10 (depends on 9)

The method of claim 9, wherein the severing comprises severing a portion of the elongate member while the portion of the elongate member is submerged in the liquid in the interior cavity of the enclosure.

### Claim 11 (depends on 7)

The method of claim 7, wherein a portion of the control cable and a portion of the elongate member are located in an interior cavity of the enclosure, at least the portion of the elongate member submerged in a liquid in the interior cavity of the enclosure.

### Claim 12 (depends on 11)

The method of claim 11, wherein the control cable lumen and the control cable each extends outwardly from the interior cavity of the enclosure through each of at least two spaced-apart openings provided in at least one wall of the enclosure.

### Claim 13 (depends on 12)

The method of claim 12, wherein the elongate member is sealed to at least a particular wall of the at least one wall of the enclosure at each of at least one of the at least two spaced-apart openings to restrict an egress of the liquid from the enclosure at the at least one of the at least two spaced-apart openings.

### Claim 14 (depends on 11)

The method of claim 11, wherein each particular part of the elongate member that is submerged in the liquid in the interior cavity of the enclosure lacks an inlet in the interior cavity of the enclosure, the inlet suitable to allow an ingress of the liquid from the interior cavity of the enclosure into the control cable lumen.

### Claim 15 (depends on 11)

The method of claim 11, comprising wetting the portion of the control cable with the liquid prior to the severing.

### Claim 16 (depends on 2)

The method of claim 2, wherein the enclosure comprises an inlet port, and the method comprises directing a first portion of the liquid from the inlet port into the interior cavity of the enclosure during the severing.

### Claim 17 (depends on 2)

The method of claim 2, wherein the enclosure comprises an inlet port and an outlet port, and the method comprises directing a first portion of the liquid from the inlet port into the interior cavity of the enclosure while expelling a fluid other than the liquid from the outlet port.

### Claim 18 (depends on 7)

The method of claim 7, wherein the first end of the elongate member is arranged to be delivered ahead of the second end of the elongate member during percutaneous delivery of at least a portion of the catheter shaft, and the method comprises providing a flow of liquid through a portion of the control cable lumen while a portion of the control cable is located in the portion of the control cable lumen, the flow of liquid flowing through the portion of the control cable lumen toward the first end.

### Claim 19 (depends on 7)

The method of claim 7, wherein the first end of the elongate member is arranged to be delivered ahead of the second end of the elongate member during percutaneous delivery of at least a portion of the catheter shaft, and the method comprises providing a flow of liquid through a portion of the control cable lumen while a portion of the control cable is located in the portion of the control cable lumen, an inlet of the flow of liquid into the portion of the control cable lumen located along the elongate member at a location spaced from each of the first end and the second end of the elongate member.

### Claim 20 (depends on 1)

The method of claim 1, comprising opening an enclosure lid providing access to an interior cavity of the enclosure via an access port made accessible by the opening of the enclosure lid, and wherein the severing comprises severing the control element within the region of the control element located within the enclosure with at least a first tool, the severing occurring at least by passing at least a portion of the at least the first tool through the access port made accessible by the opening of the enclosure lid.

### Claim 21 (depends on 1)

The method of claim 1, comprising opening an enclosure lid providing access to an interior cavity of the enclosure via an access port made accessible by the opening of the enclosure lid, and wherein the severing comprises severing the control element within the region of the control element with at least a first tool while the region of the control element is submerged in a liquid in the interior cavity of the enclosure.

### Claim 22 (depends on 1)

The method of claim 1, comprising detecting a failure condition, wherein the severing occurs in response to the detected failure condition.