# US 9,517,083 B2 · Apparatus for treating an organ and related methods of use

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- Number: US 9,517,083 B2
- Document ID: US9517083B2
- Status: Granted
- Kind: B2
- Application number: 13/599,916
- Filed: 2012-08-30
- Published: 2013-03-21
- Granted: 2016-12-13
- Earliest claimed: 2011-09-16
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: John Sherry; Sandra Nagale
- Inventors: John Sherry; Sandra Nagale
- Web page: https://patentgrep.com/patent/US9517083B2

## CPC

- A61B 17/3478: {Endoscopic needles, e.g. for infusion (biopsy needles A61B10/0233; catheters with injection needles A61M25/0067)}
- A61B 2017/00743: {Type of operation; Specification of treatment sites (A61B2017/00238 takes precedence)}
- A61B 2017/00805: {Treatment of female stress urinary incontinence}
- A61B 2017/320044: {Blunt dissectors}
- A61B 2090/3933: {Liquid markers}
- A61M 2210/1078: Urinary tract
- A61M 2210/1085: Bladder
- A61M 2210/1089: Urethra
- 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 method of treatment may include advancing a medical device to a wall of an organ having a plurality of layers of tissue. The medical device may include an elongate tube having a proximal end and a distal end, a lumen extending therebetween, and an injector disposed within the lumen. The injector may be configured to deliver a substance to a location between first and second layers of tissue of the plurality of layers of tissue within the organ wall. In addition, the method may further include delivering the substance to the location, wherein, when delivered, the substance is configured to spatially separate a portion of the first and second layers of the tissue.

## Claims

### Claim 1

A method of treatment, comprising:
advancing a medical device to a wall of an organ of a patient, the wall having a plurality of layers of tissue including, from inside out, a first layer, a second layer, and a third layer containing a muscle, wherein the medical device comprises:
an elongate tube having a proximal end and a distal end and a lumen extending therebetween; and
an injector disposed within the lumen of the elongate tube, the injector being configured to deliver a substance to one of a plurality of locations within the wall,
wherein each of the plurality of locations is disposed between an innermost surface of the first layer and an outermost surface of the second layer, the first layer being a mucosal layer of the organ, the second layer being a submucosal layer of the organ; and
delivering the substance to the plurality of locations to maintain a spatial separation between the first and second layers that modifies contraction of the muscle by inhibiting signal transduction for at least one month,
wherein at least two of the plurality locations are discontinuous with one another.

### Claim 2 (depends on 1)

The method of claim 1, further including:
resecting a portion of at least one of the first and second layers of tissue with a resection tool.

### Claim 3 (depends on 1)

The method of claim 1, further including:
extending the injector out of the lumen of the elongate tube, wherein the injector is configured to pierce the organ wall.

### Claim 4 (depends on 1)

The method of claim 1, further including:
applying suction to one of the first and second layers of tissue.

### Claim 5 (depends on 1)

The method of claim 1, wherein the organ is a bladder and the muscle is a detrusor muscle.

### Claim 6 (depends on 1)

The method of claim 1, wherein the first and second layers include nerves, the second layer including a greater number of nerves than the first layer, and the first layer further includes one of a muscarinic and cholinergic receptor.

### Claim 7 (depends on 1)

The method of claim 1, wherein the method further includes identifying a location of abnormality on the organ wall.

### Claim 8 (depends on 1)

The method of claim 1, wherein the substance is a fluid configured to cure into a solid.

### Claim 9 (depends on 8)

The method of claim 8, wherein the substance includes a hydrogel.

### Claim 10 (depends on 1)

The method of claim 1, wherein the substance is configured to deliver a drug over a period of time.

### Claim 11

A method of treating a wall of a bladder, the wall having plurality of layers including, from inside out, a first layer, a second layer, and a third layer containing a muscle, the method comprising:
positioning a distal end of a medical device adjacent to the wall of the bladder, the medical device comprising:
an elongate tube having a proximal end, a distal end, and a lumen extending therebetween; and
an injector disposed within the lumen of the elongate tube, the injector including a needle configured to pierce the wall;
advancing the injector to a plurality of locations within the wall; and
delivering a substance between an innermost surface of the first layer and an outermost surface of the second layer at each of the plurality of locations,
wherein the first layer is a mucosal layer of the bladder and the second layer is a submucosal layer of the bladder,
wherein, when delivered, the substance is configured to semi-permanently maintain a spatial separation between the first and second layers that modifies contraction of the muscle by inhibiting signal transduction for at least one month,
wherein at least two of the plurality locations are discrete from one another.

### Claim 12 (depends on 11)

The method of claim 11, further including:
resecting a portion of at least one of the first and second layers of the wall of the bladder with a resection tool.

### Claim 13 (depends on 12)

The method of claim 12, wherein the resection tool includes at least one of a hook, a snare, and a surgical blade.

### Claim 14 (depends on 11)

The method of claim 11, further including:
applying suction to one of the first and second layers.

### Claim 15

A method of treating a wall of a bladder, the wall having a plurality of layers of tissue including, from inside out, a first layer, a second layer, and a third layer containing a detrusor muscle, the method comprising:
positioning a distal end of a medical device adjacent to an anatomical area of the wall, the medical device comprising:
an elongate tube having a proximal end and a distal end and a lumen extending therebetween; and
an injector disposed within the lumen of the elongate tube, the injector including a needle configured to pierce the wall; and
advancing the injector to a plurality of locations within the wall at the anatomical area and delivering a substance to each of the plurality of locations,
wherein each of the plurality of locations is between an innermost surface of the first layer and an outermost surface of the second layer,
wherein the first layer is a urothelium and, the second layer is a lamina propria, and the anatomical area includes one of a dome, an internal sphincter, or a trigone,
wherein, when delivered, the substance is configured to maintain a spatial separation between the first and second layers that modifies contraction of the detrusor muscle by inhibiting signal transduction for at least one month, and
wherein at least two of the plurality locations are discontinuous with one another.

### Claim 16 (depends on 15)

The method of claim 15, wherein the substance includes a hydrogel.

### Claim 17 (depends on 15)

The method of claim 15, wherein each of the plurality locations is discontinuous with one another, further including:
repositioning the distal end of the medical device before delivering the substance to each of the plurality of locations.
