Method for percutaneously administering reduced pressure treatment using balloon dissection

• US 9,050,402 B2
• Filed: 03/13/2007
• Issued: 06/09/2015
• 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: Johnson, Royce W., Swain, Larry D., Cornet, Douglas A., Manwaring, Michael, Kagan, Jonathan
• Primary Examiner(s): Berdichevsky, Aarti B
• Assistant Examiner(s): SCHELL, LAURA C
• Application Number:
  US11/717,854
• Publication Number:
  US 20070219489A1
• Time in Patent Office: 3,010 Days
• Field of Search: 604/96.01, 606/198
• US Class Current: 1/1
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12181 formed by fluidized, gelatinous or cellular remodelable materials, e.g. embolic liquids, foams or extracellular matrices
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 17/12195 comprising a curable material
• 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 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]
• CPC Class Codes: A61F 2/0077 Special surfaces of prostheses, e.g. for improving ingrowth A61F2/30767 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 2002/0086 for preferentially controlling or promoting the growth of specific types of cells or tissues
• CPC Class Codes: A61F 2002/30677 Means for introducing or releasing pharmaceutical products, e.g. antibiotics, into the body
• CPC Class Codes: A61F 2002/3068 the pharmaceutical product being in a reservoir
• 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: A61H 2201/0103 : inflatable
• CPC Class Codes: A61H 9/005 : Pneumatic massage
• CPC Class Codes: A61L 31/146 : Porous materials, e.g. foams or sponges
• CPC Class Codes: A61M 1/75 : Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• 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 1/916 : specially adapted for deep wounds
• CPC Class Codes: A61M 1/92 : with liquid supply means
• CPC Class Codes: A61M 1/96 : Suction control thereof
• CPC Class Codes: A61M 1/964 : having venting means on or near the dressing
• CPC Class Codes: A61M 2025/1086 : having a special balloon surface topography, e.g. pores, protuberances, spikes or grooves
• 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 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
• CPC Class Codes: A61M 5/14 : Infusion devices, e.g. infusing by gravity; Blood infusion; Accessories therefor

Abstract

A method of administering a reduced pressure tissue treatment to a tissue site includes percutaneously inserting a tube through a skin tissue of a patient to place a distal end of the tube adjacent the tissue site, the tube having at least one passageway. A balloon associated with the tube is positioned adjacent the tissue site, and the balloon is inflated to dissect and form a void adjacent the tissue site. A manifold having a plurality of flow channels is delivered through the passageway to the tissue site. The manifold is positioned such that at least one of the flow channels is in contact with the tissue site, and a reduced pressure is applied to the tissue site through the flow channels of the manifold.

Claims

1. A method of administering a reduced pressure tissue treatment to a tissue site comprising:

percutaneously inserting a tube through a skin tissue of a patient to place a distal end of the tube adjacent the tissue site, the tube having at least one passageway;

positioning a balloon extending from the distal end of the tube adjacent the tissue site;

inflating the balloon to dissect and form a void adjacent the tissue site for receiving a manifold comprising a cellular material having a plurality of flow channels adapted to distribute reduced pressure to the tissue site and a flexible, impermeable barrier to prevent transmission of reduced pressure away from the tissue site;

rupturing or deflating the balloon after forming the void;

delivering the manifold through the passageway into the void adjacent the tissue site;

positioning the manifold such that at least one of the flow channels of the cellular material is in fluid communication with the tissue site; and

applying a reduced pressure through a fluid-delivery tube in fluid communication with the flow channels of the cellular material for providing reduced pressure to the tissue site.

2. The method according to claim 1, wherein the tube is a catheter.

3. The method according to claim 1, wherein the tube is a cannula.

4. The method according to claim 1, wherein inflating the balloon further comprises injecting a fluid into an inner space of the balloon.

5. The method according to claim 1, wherein the manifold is in a folded or compressed position as the manifold is delivered through the passageway.

6. The method according to claim 1, wherein the manifold is compressed within an impermeable membrane as the manifold is delivered through the passageway.

7. The method according to claim 6, wherein the impermeable membrane is the balloon.

8. The method according to claim 1, wherein the balloon is dissolvable in the presence of bodily tissue or bodily fluids.

9. The method according to claim 1 further comprising:

percutaneously removing the manifold following completion of the reduced pressure tissue treatment.

10. The method according to claim 1, wherein the manifold is formed from a bioresorbable material that does not require removal from the tissue site following completion of the reduced pressure tissue treatment.

11. The method according to claim 1, wherein applying a reduced pressure further comprises:

creating fluid flow through the flow channels of the manifold.

12. The method according to claim 11, wherein a fluid flowing through the flow channels is air.

13. The method according to claim 1, wherein the reduced pressure is less than a hydrostatic pressure of tissue at the tissue site.

14. The method according to claim 1, wherein the reduced pressure is less than atmospheric pressure.

15. The method according to claim 1, wherein the reduced pressure is applied cyclically.

16. The method according to claim 1, wherein the tissue site is comprised primarily of bone tissue.

17. The method according to claim 16, wherein the tissue site is located at a bone defect or fracture.

18. The method according to claim 1, wherein the tissue site is comprised of tissue selected from the group of adipose tissue, muscle tissue, neural tissue, dermal tissue, vascular tissue, connective tissue, cartilage, tendons, or ligaments.

19. The method according to claim 1, wherein the tissue site includes hard tissue.

20. The method according to claim 1, wherein the tissue site includes soft tissue.

21. The method according to claim 1 further comprising:

guiding the manifold to the tissue site using a localization technique chosen from the group of endoscopy, ultrasound, fluoroscopy, auscultation, and palpation.

22. The method according to claim 1, wherein the manifold further comprises:

a flexible wall surrounding a primary flow passage and adapted to be placed in proximity to the tissue site, the flexible wall including a plurality of apertures through the flexible wall and communicating with the primary flow passage;

a blockage prevention member positioned within the primary flow passage;

a first conduit having at least one outlet fluidly connected to the primary flow passage to deliver reduced pressure to the primary flow passage;

a second conduit having at least one outlet proximate the primary flow passage or the at least one outlet of the first conduit to purge at least one of the flow passage and the outlet of the first conduit with a gaseous fluid during the application of reduced pressure.

23. The method according to claim 22, wherein the blockage prevention member is a plurality of projections disposed on an inner surface of the flexible wall and extending into the primary flow passage.

24. The method according to claim 22, wherein the blockage prevention member is a cellular material positioned within the primary flow passage.

25. The method according to claim 1, wherein the flexible barrier and the cellular material are integral.

26. The method according to claim 1, further comprising:

delivering the balloon to the tissue site through the passageway.

27. A method of preparing a tissue site to receive a reduced pressure tissue treatment comprising:

positioning an impermeable membrane having an inner space adjacent the tissue site;

inflating the impermeable membrane to dissect and form a void adjacent the tissue site for receiving a manifold comprising a cellular material adapted to distribute reduced pressure to the tissue site and a flexible, impermeable barrier to prevent transmission of reduced pressure away from the tissue site;

rupturing or deflating the balloon after forming the void;

percutaneously delivering the manifold into the void adjacent the tissue site such that at least one of the flow channels of the cellular material is in fluid communication with the tissue site; and

applying a reduced pressure through a fluid-delivery tube in fluid communication with the flow channels of the cellular material for delivering reduced pressure to the tissue site.

28. The method according to claim 27 further comprising:

positioning the manifold such that at least one of the flow channels is in contact with the tissue site.

29. The method according to claim 27, wherein inflating the impermeable membrane further comprises:

injecting a fluid into the inner space of the impermeable membrane.

30. The method according to claim 27, wherein the manifold is delivered to the tissue site within the inner space of the impermeable membrane.

31. The method according to claim 30, wherein a reduced pressure is applied to the inner space of the impermeable membrane to compress the manifold during delivery to the tissue site.