# US 10,765,702 B2 · Vaginal laxity therapy utilizing cell-based bulking compositions

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- Number: US 10,765,702 B2
- Document ID: US10765702B2
- Status: Granted
- Kind: B2
- Application number: 15/692,823
- Filed: 2017-08-31
- Published: 2018-01-11
- Granted: 2020-09-08
- Earliest claimed: 2013-01-31
- Assignees: Boston Scientific Scimed, Inc.
- Applicants: Boston Scientific Scimed, Inc.
- Inventors: David J. Yonce
- Web page: https://patentgrep.com/patent/US10765702B2

## CPC

- A61K 35/35: Fat tissue; Adipocytes; Stromal cells; Connective tissues (adipose-derived stem cells A61K35/28; collagen A61K38/39)
- A61B 17/00: Surgical instruments, devices or methods (A61B18/00 takes precedence; dental tools A61C3/00; eye surgery A61F9/007; ear surgery A61F11/20)
- A61B 17/42: Gynaecological or obstetrical instruments or methods {(ligaturing clamps or clips for the umbilical cord A61B17/122; curettage A61B17/320708)}
- A61K 9/0034: {Urogenital system, e.g. vagina, uterus, cervix, penis, scrotum, urethra, bladder; Personal lubricants}
- A61L 27/3834: {Cells able to produce different cell types, e.g. hematopoietic stem cells, mesenchymal stem cells, marrow stromal cells, embryonic stem cells}
- A61L 27/3882: {Hollow organs, e.g. bladder, esophagus, urether, uterus}
- A61L 27/54: Biologically active materials, e.g. therapeutic substances {(A61L27/227 takes precedence)}
- A61L 29/16: Biologically active materials, e.g. therapeutic substances {(A61L29/048 takes precedence)}
- 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})
- A61F 6/08: Pessaries, i.e. devices worn in the vagina to support the uterus, remedy a malposition or prevent conception {, e.g. combined with devices protecting against contagion}
- A61K 9/0036: {Devices retained in the vagina or cervix for a prolonged period, e.g. intravaginal rings, medicated tampons, medicated diaphragms}
- A61L 2300/414: Growth factors
- A61L 2300/64: Animal cells
- A61L 2400/06: Flowable or injectable implant compositions
- A61L 2430/22: for reconstruction of hollow organs, e.g. bladder, esophagus, urether, uterus
- A61M 2025/105: {having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes}
- A61M 2037/0023: {Drug applicators using microneedles}
- A61K: PREPARATIONS FOR MEDICAL, DENTAL OR TOILETRY PURPOSES (devices or methods specially adapted for bringing pharmaceutical products into particular physical or administering forms A61J3/00; chemical aspects of, or use of materials for deodorisation of air, for disinfection or sterilisation, or for bandages, dressings, absorbent pads or surgical articles A61L; soap compositions C11D)
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- A61L: METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES (preservation of bodies or disinfecting characterised by the agents employed A01N; preserving, e.g. sterilising, food or foodstuffs A23; preparations for medical, dental or toiletry purposes A61K)
- 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)}
- A61F: FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS (dental prosthetics A61C)

## Abstract

The invention provides methods for the treatment of vaginal laxity which include delivering a cell-containing composition to the vagina. The composition can include fat tissue to provide a bulking effect to reduce the size of the vaginal opening. The cells can provide healing and revascularization of the vaginal treatment area to sustain the bulking provided by the fat. The invention also provides systems and compositions useful for performing the method, and can include instruments and devices for removal of autologous adipose tissue from a patient (e.g., by liposuction), equipment for the enrichment of cells from adipose tissue, mechanical processing of adipose tissue, and the mixing of cells and processed adipose tissue. Devices for the delivery of the cell compositions to the vagina can also be included in the system.

## Claims

### Claim 1

A system for treating vaginal laxity, comprising:
an injection system configured to deliver a composition including adipose tissue cells to a vaginal cavity, the injection system including a balloon that includes an inner wall and an outer wall defining a space therebetween to contain the composition, the balloon including a first end portion and a second end portion and a middle portion between the first end portion and the second end portion, each of the first end portion, the middle portion, and the second end portion includes a plurality of openings to deliver the composition to the vaginal cavity, the injection system configured to reduce a size of the vaginal cavity in response to the delivery of the composition into the vaginal cavity,
the injection system including a tube connected to the balloon to supply the space of the balloon with the composition, a portion of the balloon including a hub member connected to a distal end of the tube.

### Claim 2 (depends on 1)

The system of claim 1, wherein the balloon comprises micro-needles.

### Claim 3 (depends on 1)

The system of claim 1, further comprising a member for providing the composition including adipose tissue cells of a patient.

### Claim 4 (depends on 3)

The system of claim 3, wherein the member comprises a device for enriching cells from the tissue sample.

### Claim 5 (depends on 3)

The system of claim 3, wherein the member comprises a device mechanically processing adipose tissue.

### Claim 6 (depends on 3)

The system of claim 3, wherein the member comprises a liposuction instrument.

### Claim 7 (depends on 1)

The system of claim 1, wherein the inner wall is void of a plurality of openings.

### Claim 8 (depends on 1)

The system of claim 1, wherein the space of the balloon is filled with at least one of a liquid or a gas to provide pressure to expand the outer wall of the balloon to a surface of the vaginal cavity.

### Claim 9 (depends on 1)

The system of claim 1, wherein the outer wall is constructed from a biocompatible material.

### Claim 10 (depends on 1)

The system of claim 1, wherein the outer wall is constructed from a non-absorbable material.

### Claim 11 (depends on 1)

The system of claim 1, wherein the outer wall is constructed from at least one of silicone rubber, nylon, polytetrafluoroethylene (PTFE), polyamide resin, polyesters, or organosiloxanes.