# US 11,678,788 B2 · Systems and methods for use of a variable stiffness flexible elongate device

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- Number: US 11,678,788 B2
- Document ID: US11678788B2
- Status: Granted
- Kind: B2
- Application number: 16/522,569
- Filed: 2019-07-25
- Published: 2020-01-30
- Granted: 2023-06-20
- Earliest claimed: 2018-07-25
- Assignees: Intuitive Surgical Operations, Inc.
- Applicants: Intuitive Surgical Operations, Inc.
- Inventors: Joseph D. Bogusky; Kyle R. Miller; Randall L. Schlesinger; Serena H. Wong
- Web page: https://patentgrep.com/patent/US11678788B2

## CPC

- A61B 1/00078: {with stiffening means}
- A61B 1/00147: {Holding or positioning arrangements}
- A61B 1/00154: {using guiding arrangements for insertion}
- A61B 1/0052: {Constructional details of control elements, e.g. handles}
- A61B 1/008: Articulations
- A61B 1/009: {with bending or curvature detection of the insertion part}
- A61B 1/267: for the respiratory tract, e.g. laryngoscopes or bronchoscopes
- A61B 1/307: for the urinary organs, e.g. urethroscopes or cystoscopes
- A61B 5/064: {using markers (A61B5/062 takes precedence)}
- A61B 5/065: {Determining position of the probe employing exclusively positioning means located on or in the probe, e.g. using position sensors arranged on the probe}
- A61B 5/4238: {stomach}
- A61B 5/4255: {Intestines, colon or appendix}
- A61M 16/0488: {Mouthpieces; Means for guiding, securing or introducing the tubes (guiding or introducing with laryngoscopes A61B1/267; holding devices on the body A61M25/02)}
- A61M 25/0113: {Mechanical advancing means, e.g. catheter dispensers}
- A61M 25/0116: {self-propelled, e.g. autonomous robots (A61M25/0122 takes precedence)}
- A61M 25/0133: {Tip steering devices}
- A61B 2505/05: Surgical care
- A61M 31/00: Devices for introducing or retaining media, e.g. remedies, in cavities of the body (A61M25/00 takes precedence {; introducing or retaining ophthalmic products into the ocular cavities A61F9/0008})
- A61M 2025/0166: {Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided}
- A61M 2025/0681: {Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube}
- A61M 2210/005: used as an access side to the body
- A61M 2210/0625: Mouth
- A61M 2210/1032: Trachea
- A61M 2210/1053: Stomach
- A61M 2210/1057: Duodenum
- 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

The following describes various applications and uses for a controllably rigidizable flexible device or sheath. Such rigidizing mechanisms can allow for a transition between a rigid state and a flexible state of a sheath. Rigidization can be applied along an entire length of a flexible sheath or along select portions of the sheath, and the rigidization can be of varying stiffness. Rigidization can be user controlled or automatically controlled using computer processes.

## Claims

### Claim 1

A system, comprising:
an elongate device having a proximal end, a distal end, a plurality of segments positioned along a length of the elongate device between the proximal end and the distal end, and stiffening mechanisms to alter rigidity of the plurality of segments; and
a processor configured to:
monitor insertion of the elongate device relative to a reference location;
maintain, via control of the stiffening mechanisms, each of the plurality of segments that are proximal to the reference location in a first rigidity state to provide anti-buckling support of the elongate device at the plurality of segments that are proximal to the reference location; and
transition, via control of the stiffening mechanisms, each of the plurality of segments that are distal to the reference location to a second rigidity state as the elongate device is inserted, wherein the second rigidity state is less rigid than the first rigidity state.

### Claim 2 (depends on 1)

The system of claim 1, wherein the elongate device is steerable.

### Claim 3 (depends on 1)

The system of claim 1, wherein each of the plurality of segments includes at least one of the stiffening mechanisms to alter rigidity of a corresponding one of the plurality of segments.

### Claim 4 (depends on 1)

The system of claim 1, wherein the reference location is near an entry point to patient anatomy.

### Claim 5 (depends on 4)

The system of claim 4, wherein the entry point is at a natural opening of the patient anatomy or an incision in the patient anatomy.

### Claim 6 (depends on 1)

The system of claim 1, further comprising a sensor for monitoring the insertion of the elongate device.

### Claim 7 (depends on 1)

The system of claim 1, further comprising a first insertion device movable along an insertion direction and coupled to the elongate device.

### Claim 8 (depends on 1)

The system of claim 1, wherein the elongate device includes a lumen that extends from the proximal end of the elongate device to the distal end of the elongate device and through each of the plurality of segments.

### Claim 9 (depends on 8)

The system of claim 8, further comprising a flexible elongate instrument having a proximal portion and a steerable distal end, wherein the flexible elongate instrument is slidably disposed within the lumen.

### Claim 10 (depends on 9)

The system of claim 9, further comprising:
a first insertion device movable along an insertion direction and coupled to the elongate device; and
a second insertion device movable along the insertion direction and coupled to the flexible elongate instrument,
wherein the first insertion device provides independent insertion movement from insertion movement of the second insertion device.

### Claim 11

A method of using an elongate, variable stiffness device having a proximal end, a distal end, a plurality of segments positioned along a length of the variable stiffness device, and stiffening mechanisms to alter rigidity of the plurality of segments such that each of the plurality of segments is individually configurable between a rigid state and a flexible state, the method comprising:
monitoring insertion of the variable stiffness device relative to a first reference location;
maintaining, via control of the stiffening mechanisms, a first set of the plurality of segments in a first state, wherein the first set of the plurality of segments are proximal to the first reference location, wherein the first state is a rigidity state to provide anti-buckling support of the first set of the plurality of segments proximal to the first reference location; and
transitioning, via control of the stiffening mechanisms, a second set of the plurality of segments to a second state, wherein the second set of the plurality of segments are distal to the first reference location,
wherein the first state is a rigid state and the second state is a less rigid state than the first state.

### Claim 12 (depends on 11)

The method of claim 11, wherein the first reference location is near an entry point to a patient anatomy and the entry point is at a natural opening of the patient anatomy or at an incision in the patient anatomy.

### Claim 13 (depends on 11)

The method of claim 11, further comprising:
monitoring insertion of the variable stiffness device relative to a second reference location, wherein the second reference location is distal to the first reference location; and
transitioning a third set of the plurality of segments to a third state, wherein the third set of the plurality of segments are between the first reference location and the second reference location.

### Claim 14 (depends on 13)

The method of claim 13, further comprising compressing the third set of the plurality of segments.

### Claim 15 (depends on 13)

The method of claim 13, wherein the first state is a rigid state, the second state is a less rigid state than the first state, and the third state is a less rigid state than the second state.

### Claim 16 (depends on 13)

The method of claim 13, wherein the second reference location is at an entry point to a patient anatomy and the first reference location is outside of patient anatomy.

### Claim 17 (depends on 13)

The method of claim 13, wherein the first reference location is at an entry point to a patient anatomy, and the second reference location is within the patient anatomy.

### Claim 18 (depends on 17)

The method of claim 17, wherein the first reference is near a mouth of a patient and the second location is within a trachea of the patient.

### Claim 19 (depends on 11)

The method of claim 11, further comprising:
moving the elongate, variable stiffness device relative to the reference location with a first insertion device movable along an insertion direction, wherein the first set of the plurality of segments are between the first insertion device and the reference location and are unsupported.

### Claim 20 (depends on 11)

The method of claim 11, wherein the elongate, variable stiffness device includes a lumen that extends from the proximal end to the distal end and through each of the plurality of segments, the method further comprising:
moving the elongate, variable stiffness device along an insertion direction with a first insertion device coupled to the elongate, variable stiffness device; and
slidably moving a flexible elongate instrument within the lumen along the insertion direction with a second insertion device coupled to the flexible elongate instrument,
wherein movement of the elongate, variable stiffness device with the first insertion device is independent from movement of the flexible elongate instrument with the second insertion device.

### Claim 21

A system comprising:
an elongate device having a proximal end, a distal end, and a plurality of segments positioned along a length of the elongate device between the proximal end and the distal end;
a first insertion device movable along an insertion direction and coupled to the elongate device; and
a processor configured to:
monitor insertion of the elongate device relative to a reference location;
maintain each of the plurality of segments that are proximal to the reference location in a first rigidity state to provide anti-buckling support of the elongate device at the plurality of segments that are proximal to the reference location; and
transition each of the plurality of segments that are distal to the reference location to a second rigidity state as the elongate device is inserted, wherein the second rigidity state is less rigid than the first rigidity state,
wherein each of the plurality of segments that are between the first insertion device and the reference location are unsupported.