# US 11,076,743 B2 · Method and apparatus for manipulating the side wall of a body lumen or body cavity so as to provide increased visualization of the same and/or increased access to the same, and/or for stabilizing instruments relative to the same

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- Number: US 11,076,743 B2
- Document ID: US11076743B2
- Status: Granted
- Kind: B2
- Application number: 16/215,843
- Filed: 2018-12-11
- Published: 2019-11-14
- Granted: 2021-08-03
- Earliest claimed: 2009-12-15
- Assignees: Lumendi Ltd.; Cornell University
- Applicants: Lumendi Ltd.
- Inventors: John Frederick Cornhill; Jeffrey Milsom; Sameer Sharma; Tuan Anh Nguyen; Christopher Dillon; Gabriel Greeley; Rahul Sathe; Matthew DeNardo; Ashley Whitney; Jeremy Van Hill; Anthony Assal; Stephen Evans; Timothy Robinson; Alan Fortunate; Audrey Bell; Richard Yazbeck; Brian David Chouinard; Phal Kun Chan; William Rebh
- Web page: https://patentgrep.com/patent/US11076743B2

## CPC

- A61B 1/00082: {Balloons}
- A61B 1/00135: {Oversleeves mounted on the endoscope prior to insertion}
- A61B 1/00154: {using guiding arrangements for insertion}
- A61B 1/31: for the rectum, e.g. proctoscopes or sigmoidoscopes
- A61M 25/1011: {Multiple balloon catheters}
- A61M 25/1018: {Balloon inflating or inflation-control devices}
- A61M 2025/0008: {having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type}
- A61M 2025/1015: {having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system}
- 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

Apparatus comprising: a sleeve adapted to be slid over the exterior of an endoscope; an aft balloon secured to the sleeve; an inflation/deflation tube carried by the sleeve and in fluid communication with the interior of the aft balloon; a pair of hollow push tubes slidably mounted to the sleeve, the pair of hollow push tubes being connected to one another at their distal ends with a raised push tube bridge, the raised push tube bridge being configured to nest an endoscope therein; and a fore balloon secured to the distal ends of the pair of hollow push tubes, the interior of the fore balloon being in fluid communication with the interiors of the pair of hollow push tubes, wherein the fore balloon is capable of assuming a deflated condition and an inflated condition, and further wherein (i) when the fore balloon is in its deflated condition, an axial opening extends therethrough, the axial opening being sized to receive the endoscope therein, and (ii) when the fore balloon is in its inflated condition, the axial opening is closed down.

## Claims

### Claim 1

Apparatus comprising:
a sleeve adapted to be slid over an exterior of an endoscope;
an aft balloon secured to the sleeve;
a pair of push tubes slidably mounted to the sleeve, the pair of push tubes being connected to one another at their distal ends by a raised push tube bridge, the raised push tube bridge being configured to nest an endoscope therein; and
a fore balloon secured to the distal ends of the pair of push tubes, wherein the fore balloon is capable of assuming a deflated condition and an inflated condition.

### Claim 2 (depends on 1)

Apparatus according to claim 1 wherein the endoscope comprises a proximal end and a distal end, wherein the proximal end of the endoscope comprises a handle, and further wherein the sleeve is sized so as to substantially cover the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope.

### Claim 3 (depends on 1)

Apparatus according to claim 1 wherein the sleeve is configured to make a close fit with the exterior of the endoscope such that the sleeve slides over the endoscope during mounting thereon but remains in place during use of the endoscope.

### Claim 4 (depends on 1)

Apparatus according to claim 1 wherein the sleeve comprises a proximal end and a distal end, the apparatus further comprising a base secured to the sleeve at the proximal end of the sleeve.

### Claim 5 (depends on 4)

Apparatus according to claim 4 further comprising a push tube handle secured to the proximal ends of the pair of push tubes, and further wherein the base is configured to support and guide the push tube handle as the push tube handle is used to move the pair of push tubes relative to the sleeve.

### Claim 6 (depends on 1)

Apparatus according to claim 1 further comprising an inflation/deflation tube formed integral with the sleeve.

### Claim 7 (depends on 1)

Apparatus according to claim 1 wherein the sleeve comprises a pair of passageways for receiving the pair of push tubes.

### Claim 8 (depends on 7)

Apparatus according to claim 7 wherein the pair of passageways are formed integral with the sleeve.

### Claim 9 (depends on 7)

Apparatus according to claim 7 wherein each of the pair of passageways receives a support tube which receives a push tube.

### Claim 10 (depends on 1)

Apparatus according to claim 1 wherein the sleeve comprises a lumen for receiving an instrument.

### Claim 11 (depends on 10)

Apparatus according to claim 10 wherein the lumen is formed integral with the sleeve.

### Claim 12 (depends on 10)

Apparatus according to claim 10 wherein the lumen receives an instrument guide tube which receives an instrument.

### Claim 13 (depends on 1)

Apparatus according to claim 1 wherein the endoscope is steerable, wherein the steerable endoscope comprises an articulating portion, and further wherein the aft balloon is secured to the sleeve proximal to the articulating portion of the steerable endoscope.

### Claim 14 (depends on 1)

Apparatus according to claim 1 wherein the aft balloon comprises a body having a proximal opening and a distal opening, a distal extension extending distally from the body, a proximal extension extending proximally from the body, and further wherein the aft balloon is formed by everting the distal extension into an interior of the body and into an interior of the proximal extension.

### Claim 15 (depends on 1)

Apparatus according to claim 1 wherein the raised push tube bridge comprises an atraumatic tip.

### Claim 16 (depends on 1)

Apparatus according to claim 1 wherein the fore balloon comprises a body having a proximal opening and a distal opening, a proximal extension having a key-shaped cross-section comprising a pair of lobes, and a distal extension having a circular cross-section, and further wherein the fore balloon is formed by everting the distal extension into an interior of the body and into an interior of the proximal extension.

### Claim 17 (depends on 16)

Apparatus according to claim 16 wherein the pair of push tubes are disposed in the lobes before the distal extension is everted into the interior of the body.

### Claim 18 (depends on 16)

Apparatus according to claim 16 wherein at least one extruded insert is disposed adjacent to the lobes.

### Claim 19 (depends on 1)

Apparatus according to claim 1 wherein at least one of the sleeve, the aft balloon, the pair of push tubes and the fore balloon comprises a visualizable marker.

### Claim 20 (depends on 1)

Apparatus according to claim 1 further comprising an inflation mechanism for selectively inflating/deflating a selected one of the fore balloon and the aft balloon.

### Claim 21 (depends on 1)

Apparatus according to claim 1 wherein the raised push tube bridge is in the form of a ring.

### Claim 22

A method for performing a procedure in a body lumen and/or body cavity, said method comprising:
providing apparatus comprising:
a sleeve adapted to be slid over an exterior of an endoscope;
an aft balloon secured to the sleeve;
a pair of push tubes slidably mounted to the sleeve, the pair of push tubes being connected to one another at their distal ends by a raised push tube bridge, the raised push tube bridge being configured to nest an endoscope therein; and
a fore balloon secured to the distal ends of the pair of push tubes, wherein the fore balloon is capable of assuming a deflated condition and an inflated condition;
positioning the apparatus in the body lumen and/or body cavity;
inflating the aft balloon;
advancing the pair of push tubes distally;
inflating the fore balloon; and
performing the procedure.

### Claim 23 (depends on 22)

A method according to claim 22 wherein the endoscope comprises a proximal end and a distal end, wherein the proximal end of the endoscope comprises a handle, and further wherein the sleeve is sized so as to substantially cover the endoscope from a point adjacent to the distal end of the endoscope to a point adjacent to the handle of the endoscope.

### Claim 24 (depends on 22)

A method according to claim 22 wherein the sleeve is configured to make a close fit with the exterior of the endoscope such that the sleeve slides over the endoscope during mounting thereon but remains in place during use of the endoscope.

### Claim 25 (depends on 22)

A method according to claim 22 wherein the sleeve comprises a proximal end and a distal end, the apparatus further comprising a base secured to the sleeve at the proximal end of the sleeve.

### Claim 26 (depends on 25)

A method according to claim 25 further comprising a push tube handle secured to the proximal ends of the pair of push tubes, and further wherein the base is configured to support and guide the push tube handle as the push tube handle is used to move the pair of push tubes relative to the sleeve.

### Claim 27 (depends on 22)

A method according to claim 22 wherein the apparatus further comprises an inflation/deflation tube formed integral with the sleeve.

### Claim 28 (depends on 22)

A method according to claim 22 wherein the sleeve comprises a pair of passageways for receiving the pair of push tubes.

### Claim 29 (depends on 28)

A method according to claim 28 wherein the pair of passageways are formed integral with the sleeve.

### Claim 30 (depends on 28)

A method according to claim 28 wherein each of the pair of passageways receives a support tube which receives a push tube.

### Claim 31 (depends on 22)

A method according to claim 22 wherein the sleeve comprises a lumen for receiving an instrument.

### Claim 32 (depends on 31)

A method according to claim 31 wherein the lumen is formed integral with the sleeve.

### Claim 33 (depends on 31)

A method according to claim 31 wherein the lumen receives an instrument guide tube which receives an instrument.

### Claim 34 (depends on 22)

A method according to claim 22 wherein the endoscope is steerable, wherein the steerable endoscope comprises an articulating portion, and further wherein the aft balloon is secured to the sleeve proximal to the articulating portion of the steerable endoscope.

### Claim 35 (depends on 22)

A method according to claim 22 wherein the aft balloon comprises a body having a proximal opening and a distal opening, a distal extension extending distally from the body, a proximal extension extending proximally from the body, and further wherein the aft balloon is formed by everting the distal extension into an interior of the body and into an interior of the proximal extension.

### Claim 36 (depends on 22)

A method according to claim 22 wherein the raised push tube bridge comprises an atraumatic tip.

### Claim 37 (depends on 22)

A method according to claim 22 wherein the fore balloon comprises a body having a proximal opening and a distal opening, a proximal extension having a key-shaped cross-section comprising a pair of lobes, and a distal extension having a circular cross-section, and further wherein the fore balloon is formed by everting the distal extension into an interior of the body and into an interior of the proximal extension.

### Claim 38 (depends on 37)

A method according to claim 37 wherein the pair of push tubes are disposed in the lobes before the distal extension is everted into the interior of the body.

### Claim 39 (depends on 37)

A method according to claim 37 wherein at least one extruded insert is disposed adjacent to the lobes.

### Claim 40 (depends on 22)

A method according to claim 22 wherein at least one of the sleeve, the aft balloon, the pair of push tubes and the fore balloon comprises a visualizable marker.

### Claim 41 (depends on 22)

A method according to claim 22 further comprising an inflation mechanism for selectively inflating/deflating a selected one of the fore balloon and the aft balloon.

### Claim 42 (depends on 22)

A method according to claim 22 wherein the raised push tube bridge is in the form of a ring.
