# US 11,166,625 B2 · Sheath with detectable leader

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- Number: US 11,166,625 B2
- Document ID: US11166625B2
- Status: Granted
- Kind: B2
- Application number: 15/936,092
- Filed: 2018-03-26
- Published: 2019-09-26
- Granted: 2021-11-09
- Earliest claimed: 2018-03-26
- Assignees: Spiration, Inc.
- Applicants: Spiration, Inc.
- Inventors: Christopher R. Ralph
- Web page: https://patentgrep.com/patent/US11166625B2

## CPC

- A61B 1/00135: {Oversleeves mounted on the endoscope prior to insertion}
- A61B 1/00098: {Deflecting means for inserted tools}
- A61B 1/018: for receiving instruments
- A61B 5/064: {using markers (A61B5/062 takes precedence)}
- A61B 5/6886: {Monitoring or controlling distance between sensor and tissue}
- A61B 8/12: in body cavities or body tracts, e.g. by using catheters
- A61B 5/6852: {Catheters}
- A61B 2505/05: Surgical care
- A61B 2560/066: catheters therefor
- A61M 2025/0687: {having means for atraumatic insertion in the body or protection of the tip of the sheath during insertion, e.g. special designs of dilators, needles or sheaths}
- A61M 2205/0216: Materials providing elastic properties, e.g. for facilitating deformation and avoid breaking
- 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

Disclosed embodiments include apparatuses, systems, and methods for providing a sheath tip with an angled distal face to conform the sheath to a surface of tissue toward which the sheath is being extended to potentially help reduce or avoid tissue damage upon extending a sheath to convey an elongated instrument for sampling or treatment. In an illustrative embodiment, an apparatus includes a sheath tip positionable at an end of a sheath configured to convey an elongated medical instrument to a location adjacent a detection range of a detecting device. The sheath tip includes a distal member that extends a finite distance beyond the end of the sheath. The distal member is detectable by the detecting device when the end of the sheath is within the finite distance of the detection range of the detecting device.

## Claims

### Claim 1

An apparatus comprising:
a sheath tip positionable at a distal end of a sheath configured to convey an elongated medical instrument that is movable independently of the sheath to a location adjacent a detection range of a detecting device, the sheath tip including an elongated distal member formed of a plastic and that is one of integrally formed with and fixedly attached to the sheath tip and that extends a fixed distance beyond a lip of the distal end that surrounds an opening through which the elongated medical instrument exits the distal end of the sheath, the elongated distal member being detectable by the detecting device with neither of the distal end of the sheath and the elongated medical instrument being extended within the detection range of the detecting device.

### Claim 2 (depends on 1)

The apparatus of claim 1, wherein the sheath tip is an integral section of the sheath, the sheath tip being disposed at the distal end of the sheath.

### Claim 3 (depends on 1)

The apparatus of claim 1, wherein the sheath tip is a separate structure configured to be attached to the distal end of the sheath.

### Claim 4 (depends on 3)

The apparatus of claim 3, wherein the sheath tip is configured to be physically coupled to the distal end of the sheath at a sheath insert that is configured to be received within the lumen of the sheath.

### Claim 5 (depends on 1)

The apparatus of claim 1, wherein the detecting device is one of at and adjacent to an end of an insertion device, the insertion device having a first side from which the sheath is configured to be extended along an axis toward a surface.

### Claim 6 (depends on 5)

The apparatus of claim 5, wherein the elongated distal member is deformable and configured to be deflected by the surface away from the axis into the detection range of the detecting device.

### Claim 7 (depends on 6)

The apparatus of claim 6, wherein the sheath defines a lumen configured to extend the elongated medical instrument toward the surface and the sheath tip is configured to extend the lumen to the distal end of the sheath tip.

### Claim 8 (depends on 7)

The apparatus of claim 7, wherein the sheath tip defines an opening through which the elongated medical instrument extends along the axis toward the surface when the distal member is deflected by the surface.

### Claim 9 (depends on 5)

The apparatus of claim 5, wherein the elongated distal member extends from a proximal side of the sheath tip adjacent the first side of the insertion device from which the sheath is configured to be extended.

### Claim 10 (depends on 1)

The apparatus of claim 1, wherein the elongated distal member includes at least one longitudinal tongue extending the finite distance beyond the distal end of the sheath.

### Claim 11 (depends on 1)

The apparatus of claim 1, wherein the tip is configured to be deformable.

### Claim 12 (depends on 1)

The apparatus of claim 1, wherein the sheath tip has at least one characteristic chosen from a first thickness that is less than a second thickness of the sheath and a first rigidity that is less than a second rigidity of the sheath.

### Claim 13

A system comprising:
a sheath defining therein a lumen and configured with a distal end extendable toward a surface;
an elongated medical instrument configured to be conveyed through the lumen in the sheath and that is movable independently of the sheath;
an insertion control system configured to convey the sheath along an axis to a desired location, wherein the insertion control system includes:
a detecting device disposed one of at and adjacent to an end of the insertion control system and having a detection range, and
a first side from which the sheath is configured to be extended along an axis toward a surface;
an instrument control system configured to direct operation of the elongated medical instrument when the elongated medical instrument reaches a desired position; and
a sheath tip positionable at the distal end of the sheath, the sheath tip including an elongated distal member formed of a plastic and that is one of integrally formed with and fixedly attached to the sheath tip and that extends a fixed distance beyond a lip of the distal end that surrounds an opening through which the elongated medical instrument exits the distal end of the sheath, the elongated distal member being detectable by a detecting device with neither of the distal end of the sheath and the elongated medical instrument being extended within the detection range of the detecting device.

### Claim 14 (depends on 13)

The system of claim 13, wherein the sheath tip is one of:
an integral section of the sheath disposed at the distal end of the sheath; and
a separate structure configured to be attached to the distal end of the sheath.

### Claim 15 (depends on 13)

The system of claim 13, wherein the elongated distal member is deformable and configured to be deflected by the surface away from the axis into the detection range of the detecting device.

### Claim 16 (depends on 13)

The system of claim 13, wherein the sheath defines a lumen configured to extend the elongated medical instrument toward the surface and the sheath tip is configured to extend the lumen to the distal end of the sheath tip, and wherein the sheath tip defines an opening through which the elongated medical instrument extends along the axis toward the surface when the distal member is deflected by the surface.

### Claim 17 (depends on 13)

The system of claim 13, wherein the elongated distal member extends from a proximal side of the sheath tip adjacent the first side of the insertion device from which the sheath is configured to be extended.

### Claim 18 (depends on 13)

The system of claim 13, wherein the elongated distal member includes at least one longitudinal tongue extending the finite distance beyond the distal end of the sheath.

### Claim 19

A method comprising:
preparing elongated medical instrument for being conveyed into a body through a lumen in a sheath, wherein the sheath is to be extended toward a desired location adjacent a detection range of a detecting device, wherein the sheath includes a sheath tip at a distal end of the sheath, the sheath tip including an elongated distal member formed of a plastic and that is one of integrally formed with and fixedly attached to the sheath tip and that extends a fixed distance beyond a lip of the distal end that surrounds an opening through which the elongated medical instrument exits the distal end of the sheath, the elongated distal member being detectable by the detecting device with neither of the distal end of the sheath and the elongated medical instrument being extended within the detection range of the detecting device; and
inserting the sheath conveying the elongated medical instrument into the body.

### Claim 20 (depends on 19)

The method of claim 19, further comprising extending the sheath until the elongated distal member of the sheath tip is detected by the detecting device.
