# US 2010/0168688 A1 · Manifolds, systems, and methods for administering reduced pressure to a subcutaneous tissue site

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- Number: US 2010/0168688 A1
- Document ID: US20100168688A1
- Status: Published application
- Kind: A1
- Application number: 12/647,146
- Filed: 2009-12-24
- Published: 2010-07-01
- Earliest claimed: 2006-03-14
- Assignees: KCI Licensing, Inc.
- Inventors: Carl Joseph Santora; Michael E. Manwaring; Douglas A. Cornet; Justin Alexander Long; Larry D. Swain
- Web page: https://patentgrep.com/patent/US20100168688A1

## CPC

- A61B 17/88: {Osteosynthesis instruments;} Methods or means for implanting or extracting internal {or external} fixation devices {(A61B17/7074 takes precedence)}
- A61F 2/3662: {Femoral shafts}
- 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 3/0295: {with inflatable balloon}
- A61M 25/003: {characterized by features relating to least one lumen located at the distal part of the catheter, e.g. filters, plugs or valves (catheter tips A61M25/0067)}
- A61M 25/0032: {characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts}
- A61M 25/0068: {Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure}
- A61M 25/0069: {Tip not integral with tube}
- A61M 25/0074: {Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable}
- A61M 25/0082: {Catheter tip comprising a tool}
- 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})
- 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 2002/30677: {Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body}
- 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
- A61M 1/77: {Suction-irrigation systems (aspiration tips supplying fluids A61M1/85; specific for negative pressure wound therapy A61M1/92; combined with tracheal tubes A61M16/0463)}
- A61M 1/92: {with liquid supply means}
- A61M 1/94: {with gas supply means}
- A61M 25/0009: {Making of catheters or other medical or surgical tubes}
- A61M 25/007: {Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked}
- A61M 25/0071: {Multiple separate lumens (multiple separate lumens throughout the catheter A61M25/0026)}
- A61M 2025/0003: {having an additional lumen transmitting fluid pressure to the outside for measurement}
- A61M 2025/0034: {characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores}
- A61M 2025/0036: {with more than four lumina}
- A61M 2025/0076: {Unidirectional valves}
- A61M 2207/00: Methods of manufacture, assembly or production
- A61M 2210/02: Bones
- 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)
- 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

Systems, methods, and apparatuses are provided for delivering reduced pressure to a subcutaneous tissue site, such as a bone tissue site. In one instance, a manifold for providing reduced pressure to a subcutaneous tissue includes a longitudinal manifold body formed with at least one purging lumen and a reduced-pressure lumen. The manifold further includes a plurality of manifolding surface features or slits formed on the second, tissue-facing side of the longitudinal manifold body and a plurality of apertures formed in the longitudinal manifold body on the second, tissue-facing side. The plurality of apertures fluidly couple the reduced-pressure lumen and the manifolding surface features or slits. The manifold further includes an end cap fluidly coupling the reduced-pressure lumen and the at least one purging lumen. Other systems, apparatuses, and methods are presented.

## Claims

### Claim 1

A system for applying reduced pressure to a subcutaneous tissue site on a patient, the system comprising:
a reduced-pressure source operable to supply reduced pressure;
a manifold adapted to be inserted in the patient and placed at the subcutaneous tissue site, the manifold comprising:
at least one purging lumen formed in the manifold and operable to deliver a purging fluid to a distal portion of the manifold,
at least one slit formed at the distal portion of the manifold, and
at least one reduced-pressure lumen formed in the manifold and in fluid communication with the at least one slit, wherein the at least one reduced-pressure lumen is operable to deliver reduced pressure supplied from the reduced-pressure source to the subcutaneous tissue site via the at least one slit; and
a delivery tube in fluid communication with the manifold, the delivery tube delivering reduced pressure to the at least one reduced-pressure lumen and the purging fluid to the at least one purging lumen.

### Claim 2 (depends on 1)

The system of claim 1, wherein the manifold further comprises at least one interlumen channel fluidly interconnecting at least two of the at least one purging lumen, the at least one reduced-pressure lumen, and the at least one slit at the distal portion of the manifold.

### Claim 3 (depends on 1)

The system of claim 1, wherein the at least one slit extends to the distal end of the manifold.

### Claim 4

An apparatus for applying reduced pressure to a subcutaneous tissue site on a patient, the apparatus comprising:
a manifold adapted to be inserted into the patient and for placement at the subcutaneous tissue site, the manifold comprising:
at least one purging lumen formed in the manifold and operable to deliver a purging fluid to a distal portion of the manifold,
at least one slit at the distal portion of the manifold, and
at least one reduced-pressure lumen formed in the manifold and in fluid communication with the at least one slit, wherein the at least one reduced-pressure lumen is operable to deliver reduced pressure to the subcutaneous tissue site via the at least one slit.

### Claim 5 (depends on 4)

The apparatus of claim 4, wherein the manifold further comprises at least one interlumen channel fluidly interconnecting at least two of the at least one purging lumen, the at least one reduced-pressure lumen, and the at least one slit at the distal portion of the manifold.

### Claim at position 6

-7. (canceled)

### Claim 8 (depends on 4)

The apparatus of claim 4, wherein the at least one reduced-pressure lumen terminates at the at least one slit.

### Claim at position 8

-10. (canceled)

### Claim 11 (depends on 4)

The apparatus of claim 4, further comprising:
a delivery tube in fluid communication with the manifold, the delivery tube delivering reduced pressure to the at least one reduced-pressure lumen and the purging fluid to the at least one purging lumen,
wherein the delivery tube has at least one fluid delivery lumen and at least one reduced-pressure delivery lumen,
wherein the at least one fluid delivery lumen delivers the fluid to the at least one purging lumen, and
wherein the at least one reduced-pressure delivery lumen delivers reduced pressure to the at least one reduced-pressure lumen.

### Claim 12 (depends on 4)

The apparatus of claim 4, wherein the manifold further comprises an end cap that is attachable to an end of the manifold to form a head space, and wherein the head space is adapted to accumulate fluid from the at least one purging lumen prior to the fluid being drawn via the at least one reduced-pressure lumen.

### Claim at position 11

-17. (canceled)

### Claim 18 (depends on 4)

The apparatus of claim 4, wherein the at least one purging lumen is a plurality of purging lumens that are spaced at equal intervals around a central longitudinal axis of the manifold, and wherein each of the plurality of purging lumens is substantially pie-shaped in cross section.

### Claim at position 13

-20. (canceled)

### Claim 21 (depends on 4)

The apparatus of claim 4, wherein the manifold comprises a first sheet and a second sheet, wherein a perimeter of the first sheet is attached to a perimeter of the second sheet to form a pouch, and wherein the at least one reduced-pressure lumen is a reduced-pressure cavity at least partially enclosed by the pouch.

### Claim at position 15

-29. (canceled)

### Claim 30 (depends on 4)

The apparatus of claim 4, wherein the manifold is coated with at least one of heparin and parylene.

### Claim 31

An method for applying reduced pressure to a subcutaneous tissue site, the method comprising:
applying a manifold to the subcutaneous tissue site, the manifold comprising:
at least one purging lumen operable to deliver a fluid to a distal portion of the manifold,
at least one slit at the distal portion of the manifold, and
at least one reduced-pressure lumen operable to deliver reduced pressure to the subcutaneous tissue site via the at least one slit; and
supplying a reduced pressure to the manifold via a delivery tube.

### Claim at position 18

-33. (canceled)

### Claim 34

A manifold for providing reduced pressure to a subcutaneous tissue site on a patient, the manifold comprising:
a longitudinal manifold body formed with at least one purging lumen and a reduced-pressure lumen, the longitudinal manifold body having a first side and a second, tissue-facing side;
a plurality of manifolding surface features formed on the second, tissue-facing side of the longitudinal manifold body;
a plurality of apertures formed in the longitudinal manifold body on the second, tissue-facing side, wherein the plurality of apertures fluidly couple the reduced-pressure lumen and the plurality of manifolding surface features; and
an end cap fluidly coupling the reduced-pressure lumen and the at least one purging lumen.

### Claim 35 (depends on 34)

The manifold of claim 34, wherein the plurality of manifolding surface features comprise a plurality of recesses.

### Claim 36 (depends on 34)

The manifold of claim 34, wherein the plurality of manifolding surface features comprise a plurality of offsets.

### Claim 37 (depends on 34)

The manifold of claim 34, wherein the end cap is formed integrally with the longitudinal manifold body.

### Claim 38 (depends on 34)

The manifold of claim 34, wherein the longitudinal manifold body has an aspect ratio greater than 10.

### Claim 39 (depends on 34)

The manifold of claim 34, wherein the manifold body and surface features comprise a bioreaborbable material.

### Claim 40 (depends on 34)

The manifold of claim 34, wherein the surface features are bioreaborbable.

### Claim 41 (depends on 34)

The manifold of claim 34, wherein the surface features are detachable and are operable to detach when percutaneously removed from the patient.

### Claim 42

A system for treating a subcutaneous tissue site on a patient with reduced pressure, the system comprising:
a reduced-pressure source;
a manifold comprising:
a longitudinal manifold body formed with at least one purging lumen and a reduced-pressure lumen, the longitudinal manifold body having a first side and a second, tissue-facing side,
a plurality of manifolding surface features formed on the second, tissue-facing side of the longitudinal manifold body,
a plurality of apertures formed in the longitudinal manifold body on the second, tissue-facing side, wherein the plurality of apertures fluidly couple the reduced-pressure lumen and the plurality of manifolding surface features, and
an end cap fluidly coupling the reduced-pressure lumen and the at least one purging lumen; and
a reduced pressure delivery tube coupling the reduced-pressure source and the manifold.

### Claim 43 (depends on 42)

The system of claim 42, wherein the plurality of manifolding surface features comprise a plurality of recesses.

### Claim 44 (depends on 42)

The system of claim 42, wherein the plurality of manifolding surface features comprise a plurality of offsets.

### Claim 45 (depends on 42)

The system of claim 42, wherein the end cap is formed integrally with the longitudinal manifold body.

### Claim 46 (depends on 42)

The system of claim 42, wherein the longitudinal manifold body has an aspect ratio greater than 10.

### Claim 47 (depends on 42)

The system of claim 42, wherein the manifold body and surface features comprise a bioreaborbable material.

### Claim 48 (depends on 42)

The system of claim 42, wherein the surface features are bioreaborbable.

### Claim 49 (depends on 42)

The system of claim 42, wherein the surface features are detachable and are operable to detach when percutaneously removed from the patient.

### Claim at position 35

-53. (canceled)