Manifolds, systems, and methods for administering reduced pressure to a subcutaneous tissue site

• US 8,939,933 B2
• Filed: 12/24/2009
• Issued: 01/27/2015
• Est. Priority Date: 03/14/2006
• Status: Active Grant

• Current Assignee: Solventum Intellectual Properties Company (Solventum Corp.)
• Original Assignee: KCI Licensing Incorporated (3M Company)
• Inventors: Santora, Carl Joseph, Manwaring, Michael E., Cornet, Douglas A., Long, Justin Alexander, Swain, Larry D.
• Primary Examiner(s): Bosques, Edelmira
• Application Number:
  US12/647,146
• Publication Number:
  US 20100168688A1
• Time in Patent Office: 1,860 Days
• Field of Search: 604/93.01, 604/131, 604/43
• US Class Current: 604/131
• CPC Class Codes: A61B 17/1355 Automated control means therefor
• CPC Class Codes: A61B 17/80 Cortical plates , i.e. bone plates; Instruments for holding or positioning cortical plates, or for compressing bones attached to cortical plates
• CPC Class Codes: A61B 17/88 Osteosynthesis instruments; Methods or means for implanting or extracting internal or external fixation devices A61B17/7074 takes precedence
• CPC Class Codes: A61F 2/30767 Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• CPC Class Codes: A61F 2/3662 Femoral shafts
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/30785 parallel
• CPC Class Codes: A61F 2002/30787 inclined obliquely with respect to each other
• CPC Class Codes: A61F 2002/30968 Sintering
• CPC Class Codes: A61F 2002/3611 Heads or epiphyseal parts of femur
• CPC Class Codes: A61F 2002/3625 Necks
• CPC Class Codes: 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
• CPC Class Codes: A61F 2002/3694 with longitudinal bores
• CPC Class Codes: A61F 2310/00395 Coating or prosthesis-covering structure made of metals or of alloys
• CPC Class Codes: A61F 2310/00592 Coating or prosthesis-covering structure made of ceramics or of ceramic-like compounds
• CPC Class Codes: A61F 2310/00928 Coating or prosthesis-covering structure made of glass or of glass-containing compounds, e.g. of bioglass
• CPC Class Codes: 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
• CPC Class Codes: 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
• CPC Class Codes: A61M 1/915 Constructional details of the pressure distribution manifold
• CPC Class Codes: A61M 1/92 : with liquid supply means
• CPC Class Codes: A61M 1/94 : with gas supply means
• CPC Class Codes: A61M 2025/0003 : having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0034 : characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores
• CPC Class Codes: A61M 2025/0036 : with more than four lumina
• CPC Class Codes: A61M 2025/0076 : Unidirectional valves
• CPC Class Codes: A61M 2207/00 : Methods of manufacture, assembly or production
• CPC Class Codes: A61M 2210/02 : Bones
• CPC Class Codes: A61M 25/0009 : Making of catheters or other medical or surgical tubes
• CPC Class Codes: 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
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/0069 : Tip not integral with tube
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0071 : Multiple separate lumens multiple separate lumens throughout the catheter A61M25/0026
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: 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
• CPC Class Codes: A61M 3/0295 : with inflatable balloon

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

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 fluid source operable to supply a purging fluid;

a manifold having a flattened shape including a flat side and an opposing side opposite the flat side, a width defined by the width of the flat side and a height defined by the distance between the flat side and the opposing side wherein the width is greater than the height, and a distal portion 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 in fluid communication with the fluid source to deliver the purging fluid to the distal portion of the manifold,

at least one slit formed in the flat side only at the distal portion of the manifold and adapted to be facing the subcutaneous tissue site, and

at least one reduced-pressure lumen formed in the manifold, the at least one reduced-pressure lumen extending toward the distal end of the manifold and opening toward the flat side of the manifold to become 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 having at least one reduced-pressure delivery lumen adapted to deliver reduced pressure to the at least one reduced-pressure lumen and having at least one fluid delivery lumen adapted to deliver the purging fluid to the at least one purging lumen.

2. 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, and the at least one reduced-pressure lumen.

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

4. An apparatus for applying reduced pressure to a subcutaneous tissue site on a patient, the apparatus comprising:

a manifold having a flattened shape including a flat side and an opposing side opposite the flat side, a width defined by the width of the flat side and a height defined by the distance between the flat side and the opposing side wherein the width is greater than the height, and a distal portion 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 the distal portion of the manifold,

at least one slit formed in the flat side only at the distal portion of the manifold and adapted to be facing the subcutaneous tissue site,

at least one reduced-pressure lumen formed in the manifold, the at least one reduced-pressure lumen extending toward the distal end of the manifold and opening toward the flat side of the manifold to become 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; and

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.

5. 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, and the at least one reduced-pressure lumen.

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

7. 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.

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

9. A method for applying reduced pressure to a subcutaneous tissue site, the method comprising:

applying a manifold having a flattened shape including a flat side and an opposing side opposite the flat side, a width defined by the width of the flat side and a height defined by the distance between the flat side and the opposing side wherein the width is greater than the height, and a distal portion to the subcutaneous tissue site, the manifold comprising;

at least one purging lumen operable to deliver a fluid to the distal portion of the manifold,

at least one slit formed in the flat side only at the distal portion of the manifold and adapted to be facing the subcutaneous tissue site, and

at least one reduced-pressure lumen extending toward the distal end of the manifold and opening toward the flat side of the manifold to become the at least one slit, the at least one reduced-pressure lumen operable to deliver reduced pressure to the subcutaneous tissue site via the at least one slit;

supplying a reduced pressure to the manifold via a reduced-pressure delivery lumen in a delivery tube; and

supplying the fluid to the manifold via a fluid delivery lumen in the delivery tube.