# US 8,771,253 B2 · System and method for percutaneously administering reduced pressure treatment using a flowable manifold

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- Number: US 8,771,253 B2
- Document ID: US8771253B2
- Status: Granted
- Kind: B2
- Application number: 13/572,348
- Filed: 2012-08-10
- Published: 2013-01-24
- Granted: 2014-07-08
- Earliest claimed: 2006-03-14
- Assignees: KCI Licensing, Inc.
- Applicants: Royce W. Johnson; Archel A. Ambrosio; Larry D. Swain; Joanna Payne
- Inventors: Royce W. Johnson; Archel A. Ambrosio; Larry D. Swain; Joanna Payne
- Web page: https://patentgrep.com/patent/US8771253B2

## CPC

- A61B 17/88: {Osteosynthesis instruments;} Methods or means for implanting or extracting internal {or external} fixation devices {(A61B17/7074 takes precedence)}
- A61F 2/0077: {Special surfaces of prostheses, e.g. for improving ingrowth (A61F2/30767 takes precedence)}
- A61F 2/3662: {Femoral shafts}
- A61H 9/005: {Pneumatic massage}
- A61L 31/146: {Porous materials, e.g. foams or sponges}
- A61M 1/85: {with gas or fluid supply means, e.g. for supplying rinsing fluids or anticoagulants (for negative pressure wound therapy A61M1/92, A61M1/94; combined with tracheal tubes A61M16/0463; dental instruments with combined rinsing and aspirating A61C17/0208)}
- A61M 1/915: {Constructional details of the pressure distribution manifold}
- A61M 1/916: {specially adapted for deep wounds}
- A61M 1/964: {having venting means on or near the dressing}
- A61M 5/14: Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor
- A61M 27/00: Drainage appliance for wounds or the like {, i.e. wound drains, implanted drains} ({negative pressure wound therapy devices A61M1/90;} implements for holding wound open A61B17/02 {; middle ear drainage A61F11/202})
- A61M 37/00: Other apparatus for introducing media into the body (for reproduction or fertilisation A61B17/425; apparatus for iontophoresis or cataphoresis A61N1/30); Percutany, i.e. introducing medicines into the body by diffusion through the skin (salt baths A61H33/04)
- A61B 17/12168: {having a mesh structure (A61B17/1214 takes precedence)}
- A61B 17/12181: {formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices}
- A61B 17/12186: {liquid materials adapted to be injected}
- A61B 17/1219: {expandable in contact with liquids}
- A61B 17/12195: {comprising a curable material}
- A61B 17/1355: {Automated control means therefor}
- A61B 17/80: Cortical plates {, i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates}
- A61F 2/30767: {Special external or bone-contacting surface, e.g. coating for improving bone ingrowth}
- A61F 2/36: Femoral heads {; Femoral endoprostheses}
- A61F 13/05: specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
- A61F 2002/0086: {for preferentially controlling or promoting the growth of specific types of cells or tissues}
- A61F 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- A61F 2002/3068: {the pharmaceutical product being in a reservoir}
- A61F 2002/30785: {parallel}
- A61F 2002/30787: {inclined obliquely with respect to each other}
- A61F 2002/30968: {Sintering}
- A61F 2002/3611: {Heads or epiphyseal parts of femur}
- A61F 2002/3625: {Necks}
- A61F 2002/368: {with lateral apertures, bores, holes or openings, e.g. for reducing the mass, for receiving fixation screws or for communicating with the inside of a hollow shaft}
- A61F 2002/3694: {with longitudinal bores}
- A61F 2310/00395: Coating or prosthesis-covering structure made of metals or of alloys
- A61F 2310/00592: Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
- A61F 2310/00928: Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass
- A61H 2201/0103: inflatable
- A61M 1/75: {Intermittent or pulsating suction (A61M1/63, A61M1/772 take precedence)}
- A61M 1/92: {with liquid supply means}
- A61M 1/96: {Suction control thereof}
- A61M 2025/1086: {having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves}
- A61B: DIAGNOSIS; SURGERY; IDENTIFICATION (usefulness limited to only animals A61D)
- 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)
- A61H: PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY (electrotherapy, magnetotherapy, radiation therapy or ultrasound therapy A61N)
- 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)}

## Abstract

A reduced pressure delivery system for applying a reduced pressure to a tissue site includes a manifold delivery tube having a passageway and a distal end, the distal end configured to be percutaneously inserted and placed adjacent the tissue site. A flowable material is provided and is percutaneously deliverable through the manifold delivery tube to the tissue site. The flowable material is capable of filling a void adjacent the tissue site to create a manifold having a plurality of flow channels in fluid communication with the tissue site. A reduced pressure delivery tube is provided that is capable of fluid communication with the flow channels of the manifold.

## Claims

### Claim 1

A method of administering a reduced pressure therapy to a tissue site comprising:
percutaneously positioning a distal end of a manifold delivery tube adjacent a tissue site;
percutaneously delivering a flowable material through the manifold delivery tube to the tissue site, the flowable material being capable of filling a void adjacent the tissue site to create a manifold having a plurality of flow channels in fluid communication with the tissue site;
applying a reduced pressure to the tissue site through the manifold delivery tube and the flow channels of the manifold.

### Claim 2 (depends on 1)

The method according to claim 1, wherein the manifold is bioresorbable.

### Claim 3 (depends on 1)

The method according to claim 1, wherein the manifold serves as a scaffold for tissue growth.

### Claim 4 (depends on 1)

The method according to claim 1, wherein the manifold foams and undergoes a phase change in the presence of at least one of a bodily fluid and a bodily temperature.

### Claim 5 (depends on 4)

The method according to claim 4, wherein the manifold is a gel.

### Claim 6 (depends on 1)

The method according to claim 1, wherein the manifold further comprises a bioresorbable polymer dissolved in a solvent and mixed with sodium bicarbonate and citric acid.

### Claim 7 (depends on 6)

The method according to claim 6, wherein the bioresorbable polymer is one of a polylactide-co-glycolide (PLAGA) polymer and a polyethylene glycol-PLAGA copolymer.

### Claim 8 (depends on 6)

The method according to claim 6, wherein the solvent is methylene chloride.

### Claim 9 (depends on 1)

The method according to claim 1, wherein the flowable material is selected from the group consisting of a liquid, a slurry, a suspension, a viscous gel, a paste, a putty, and particulate solids.

### Claim 10 (depends on 1)

The method according to claim 1, wherein:
the flowable material undergoes a phase change in the presence of at least one of a bodily fluid and a bodily temperature; and
the flowable material includes a poragen that dissolves following curing of the flowable material, the dissolution of the poragen creating the plurality of flow channels.

### Claim 11 (depends on 1)

The method according to claim 1, wherein the flowable material includes microspheres having a coating that is capable of being selectively crosslinked following delivery of the flowable material to the tissue site.

### Claim 12 (depends on 11)

The method according to claim 11, wherein the coating is selectively crosslinked in response to at least one of heat, light, and a chemical.

### Claim 13 (depends on 11)

The method according to claim 11, wherein the microspheres following crosslinking create the plurality of flow channels.

### Claim 14 (depends on 1)

The method according to claim 1, wherein:
the flowable material is selected from the group consisting of a paste and a putty having an initial viscosity;
the viscosity of the flowable material decreases below the initial viscosity in the presence of shear forces during delivery to the tissue site; and
the viscosity of the flowable material reverts to the initial viscosity following delivery of the flowable material to the tissue site.

### Claim 15

A method of delivering reduced pressure to a tissue site comprising:
inserting a delivery tube percutaneously to a void in the tissue site;
delivering a material through the delivery tube to the void;
forming flow channels in situ in the material; and
delivering a reduced pressure to the tissue site through the delivery tube and the flow channels.

### Claim 16 (depends on 15)

The method of claim 15, wherein forming the flow channels comprises hardening the material in the void into a solid state.

### Claim 17 (depends on 15)

The method of claim 15, wherein forming the flow channels comprises forming a foam from the material in the void.

### Claim 18 (depends on 15)

The method of claim 15, wherein forming the flow channels comprises dissolving poragens in the material.

### Claim 19 (depends on 15)

The method of claim 15, wherein forming the flow channels comprises dissolving sodium chloride in the material.

### Claim 20

A method of delivering reduced pressure to a tissue site, the method comprising:
percutaneously inserting a delivery tube adjacent a tissue site;
percutaneously delivering a flowable material through the delivery tube to a void adjacent to the tissue site, the flowable material adapted to create a manifold in the void having a plurality of flow channels in fluid communication with the tissue site;
applying a reduced pressure to the tissue site through the delivery tube and the flow channels of the manifold.