US 7,754,936 B2Grant
Wound treatment apparatus employing reduced pressure
Issue Date:2010-07-13
•11 Claims
•5 Drawing Sheets
Abstract
A method for stimulating new tissue growth is provided in which a limb is introduced into an interior portion of an outer cover. A porous component is applied to at least a portion of the limb within the outer cover. An opening through which the limb was introduced is sealed, and a negative pressure is applied to the interior portion to stimulate new tissue growth.
Metadata
Inventors
- Keith Patrick Heaton
- Kenneth William Hunt
Application Information
Application Number:US 11/973,227
Filing Date:2007-10-05
Priority Date:1999-04-22
Art Unit:3772
Classifications
IPC:
A61F13/00
Patent Drawings (5 sheets)
Description
Cross-Reference to Related Applications
[0001] This application is a divisional of U.S. patent application Ser. No. 10/009,294, filed Jun. 6, 2002 now U.S. Pat. No. 7,279,612, which was the National Stage of International Application No. PCT/GB00/01566, filed Apr. 20, 2000, which claims the benefit of United Kingdom Application No. 9909301.5, filed Apr. 22, 1999. Priority is claimed to all of the above-mentioned applications, and each application is hereby incorporated by reference.
Background of the Invention
[0002] 1. Field of the Invention
[0003] The present invention relates to an apparatus for the healing of wounds and more particularly to preventing progression of partial-thickness burns.
[0004] 2. Description of Related Art
[0005] Where a person suffers a burn, the dermal and epidermal layers in the region of the wound are damaged. Closure of the resulting wound is important to prevent loss of body fluids and invasion by micro-organisms. In the case of a partial-thickness burn, epithelial and subcutaneous tissue adjacent to the wound will migrate outwards and eventually grow new tissue over the wound. A wide array of wound coverings has been developed to expedite wound closure and allow the natural processes of repairing the damaged tissue to proceed.
[0006] The prognosis of a wound caused by a burn depends on the severity of the injury and particularly the depth of the burn. In general, a partial-thickness burn will heal more quickly and with less complications than a deeply penetrating burn. It has been observed that partial-thickness burns often deteriorate and become more serious, deeper burns, if not treated promptly after incurring the burn injury.
[0007] The hands more often suffer burn injuries than other parts of the body. Probably, this is due to the natural reaction of attempting to protect the face with the hands and, in many cases, the burn injury is to the back of the hands. Other parts of the body which more frequently suffer burns may be the arms, feet and legs.
[0008] The present invention seeks to provide apparatus for treating injuries to a part of the body, especially injuries caused by burns.
Brief Summary of the Invention
[0009] According to one aspect of the invention there is provided an apparatus for stimulating healing of wounds which comprises an envelope for receiving an affected part of the body, said envelope including a substantially air-tight cover and a porous pad within the cover, said cover being adapted to contact the wound surface, and connection means for connecting the interior of the envelope to a source of negative pressure.
[0010] By substantially “air-tight” cover is meant one which is sufficiently air-tight that by applying suction to the porous pad, a pressure below ambient can be maintained within the envelope. It is not, however, necessary for the material of the envelope to be totally air occlusive.
[0011] It has been found that when negative pressure therapy using the apparatus of the invention is applied to a burn within a relatively short time of incurring the injury (e.g. within about 12 hours), not only is the rate of healing improved but progression of a partial-thickness burn to a deeper injury is arrested.
[0012] In one embodiment, the apparatus of the invention, the envelope comprises a glove, sleeve or sock. For example, the apparatus may include a glove formed from a flexible plastics or rubber foam which is contained within a cover of low air-porosity. Typically, the flexible plastics foam is a polyurethane or polyvinyl alcohol (PVA) foam having intercommunicating cells or a combination of such foams, e.g. as a laminate. In such a laminate, the PVA layer may be adjacent the wound.
[0013] In another embodiment of the present invention, a method for stimulating new tissue growth is provided. A limb is introduced into an interior portion of an outer cover, and a porous component is applied to at least a portion of the limb within the outer cover. An opening through which the limb was introduced is sealed, and a negative pressure is applied to the interior portion to stimulate new tissue growth.
[0014] Other objects, features, and advantages of the present invention will become apparent with reference to the drawings and detailed description that follow.
Brief Description of the Drawings
[0015] Additional features of the present application will become apparent from the following description and accompanying drawings, in which:
[0016] FIG. 1 is an exploded perspective view of the porous pad;
[0017] FIG. 2 is a perspective view when the porous pad is assembled together;
[0018] FIG. 3 is a perspective view of the porous pad within its cover;
[0019] FIG. 4 a to 4d show various views of a connector for pneumatically connecting the porous pad to a source of negative pressure; and
[0020] FIG. 5 is a plan view of a modified cover.
Detailed Description of the Preferred Embodiment
[0021] In the following detailed description of the preferred embodiments, reference is made to the accompanying drawings that form a part hereof, and in which is shown by way of illustration specific preferred embodiments in which the invention may be practiced. These embodiments are described in sufficient detail to enable those skilled in the art to practice the invention, and it is understood that other embodiments may be utilized and that logical structural, mechanical, electrical, and chemical changes may be made without departing from the spirit or scope of the invention. To avoid detail not necessary to enable those skilled in the art to practice the invention, the description may omit certain information known to those skilled in the art. The following detailed description is, therefore, not to be taken in a limiting sense, and the scope of the present invention is defined only by the appended claims.
[0022] The embodiment shown in the accompanying drawings is designed for use in treating burns to the hand, but it will be appreciated that various appropriate modifications are possible for treating burns to other parts of the body, such as feet and other extremities, within the scope of the invention.
[0023] FIGS. 1 , 2 and 3 show apparatus (10) for treating wounds to the hands comprising a porous pad having a lower base (22), a middle section (24) and an upper section (26) incorporated within a cover (12) of low air porosity. The porous pad is in the form of a glove or mitten and may be constructed by fixing the upper section (26) to the base (22) while retaining the middle section (24) within the cavity so formed. Typically, the porous pad is a reticulated plastics foam, and may be formed by gluing or welding the separate sections together. When placed inside the pad, the hand is held in place with fingers spread by finger-separators (25) and V-cut type grooves (14). As shown in FIGS. 2 and 3 , the foam may be shaped to provide for a separate supporting compartment (27) for the thumb to aid the attainment of the optimum positions of the fingers and thumb for healing. However, this is not essential. The pad is preferably made from a reticulated foam such as polyurethane as described in PCT application WO 96/05873, polyvinylalcohol foam or a combination thereof.
[0024] FIG. 3 shows the assembled pad after insertion into a cover (12). Cover (12) is an envelope formed from air-impermeable sheet material, e.g. polyurethane or polyolefin film, and is sized to encompass the glove-shaped porous pad. The distal end of the cover (12) has a large opening (not shown) which is closable by an easily re-sealable means (4) such as a zip-type seal used on food bags. The proximal end (8) includes a substantially impermeable pressure-sensitive acrylic resin adhesive (9), the underside of which is secured as an air-tight seal to the patient's skin. The proximal end (8) may be coated on its inner surface with a pressure-sensitive acrylic resin adhesive (9) in order to seal the cover to the patient's skin, e.g. at the wrist or lower arm. Alternatively, the proximal end (8) may be sealed to the patient's wrist with a separate piece of adhesive tape, such as a polyurethane film coated with a pressure-sensitive adhesive. The proximal end (8) is open and is tapered as shown. By providing a taper, the proximal end can be cut to a size such that the opening will fit snugly around the patient's wrist. Attached to the cover (12) in the region of a central part of the porous pad is a connector (100). Connector (100) may be attached to the cover by adhesive.
[0025] FIG. 5 is a plan view of a cover similar to cover (12) shown in FIG. 3 . The same reference numerals are used to indicate corresponding parts. The cover shown in FIG. 5 differs from that shown in FIG. 3 in that the end (8) for attachment at the patient's wrist has a somewhat larger taper and is designed so that the end can be trimmed to suit the patient. The connector (100) has a generally circular flange (101) whose underside face (i.e. the face which in use contacts the foam page 20) is formed with small projecting buttons. The construction of this aspect of the connector is as described in GB Patent Application No. 2,333,965. Instead of using a zip lock seal, a VELCRO®-type hook and loop fastener can be used. In this embodiment, a zip lock seal (4) is formed from polyethylene and this is joined to the rest of the cover, which is formed from polyurethane, by adhesive tape.
[0026] FIGS. 4 a to 4d show various views of the connector (100) and it will be seen that it comprises a molded plastics flange portion (101) and suction port having a centrally positioned spout (102) and aperture (106). The connector (100) is firmly attached to the cover by an adhesive. The spout extends through a hole cut in the cover and the upper surface of the flange (101) is bonded with adhesive to the cover (12). The spout (102) is sized to accept as a closely sliding fit, the end of a single or multi-lumen tube (30) (FIG. 3 ) which emerges from beneath the wound cover (12). Tube (30) may be constructed as described in co-pending patent application WO 97/18007. Where a multi-lumen tube is used, one lumen can be used for measuring the pressure at the burn site. It is also within the scope of this invention to irrigate the burn or other wound through one of the lumens or via a separate connector to the foam pad. The connector or connectors can be used to introduce drugs, e.g. antibiotics, to the wound site. The cover drape (12) is preferably made from a flexible film of low air permeability such as polyurethane and may include a protective layer of polyethylene. Suitable materials are described in GB Patent Application No. 2,333,965.
[0027] In use, the hand of a patient having a burn injury is introduced into the outer cover (12) via the end (8). Re-sealable opening (4) may then be opened and folded back to expose the injured hand. The hand is then introduced into the porous pad which may be pre-assembled or assembled in situ around the injured hand. In the latter case, it may be convenient to fix the upper section (26) to the lower base (24) by suturing or stapling, rather than gluing or welding the foam. With the foam pad in place encompassing the injured hand, the cover (12) is drawn over the porous pad and the opening (4) re-sealed. Spout (102) is then connected by a tube to a suction pump, e.g. using the technique described in WO 97/108007. Pulsed, intermittent or continuous negative pressure may be applied to the patient's hand in accordance with a program which may be controlled automatically by a control device associated with the pump as described in our above patent application. Negative pressure therapy using the apparatus of the invention has been found to stimulate healing of burns and to reduce the progression of cell death beneath a burn injury. Also, by improving blood flow to the wound area, infection is controlled and granulation of the wound is stimulated.
[0028] One additional beneficial effect of therapy using the apparatus of this invention is that during therapy, the hand is held firmly in a half-closed position, which is the optimum position for promotion of healing. This can be further encouraged by the introduction of a rigid or semi-rigid splint, e.g. of plastics, which is formed or molded into the desired shape, the collapsed dressing being strapped to the splint during or after application of the suction, so that the desired healing position can be maintained after release of the suction.
[0029] The suction pump is perfectly controlled by control means including a pressure transducer for monitoring pressure at the wound site as described in our above PCT application. A timer device may also be associated with the pump to provide on/off operation if necessary at selected intervals. The apparatus may also include a canister located between the porous pad and the pump to collect wound exudate. Typically, the pump is a diaphragm pump but other types of pumps and equivalent components, such as vacuum bottles may be substituted. The apparatus may also be used with a wall suction source as described in GB Patent Application No. 2,342,584.
[0030] The terms and expressions which have been employed are used as terms of description and not of limitation. Although the present invention relates mainly to partial-thickness burns, it is understood that the present invention maybe used with open wounds as well as a possible treatment of pressure sores.
[0031] It should be apparent from the foregoing that an invention having significant advantages has been provided. While the invention is shown in only a few of its forms, it is not just limited but is susceptible to various changes and modifications without departing from the spirit thereof.
Claims
We claim:
1. A method for stimulating new tissue growth, comprising:
introducing a limb of a patient into an interior portion of an outer cover via an opening of the outer cover;
unsealing a second opening;
exposing the limb through the unsealed second opening to apply the porous component to the limb;
applying a porous component to at least a portion of the limb within the outer cover;
resealing the second opening;
sealing the opening; and
stimulating new tissue growth by applying a negative pressure to the interior portion of the outer cover.
2. The method according to claim 1, wherein applying the negative pressure further comprises applying an intermittent negative pressure to the limb sealed in the outer cover.
3. The method according to claim 1, wherein applying the negative pressure further comprises applying a continuous negative pressure to the limb sealed in the outer cover.
4. The method according to claim 1, further comprising automatically controlling the application of negative pressure using a control device operably associated with a pump.
5. The method according to claim 1, wherein unsealing further comprises unsealing a zip seal.
6. The method according to claim 1, wherein applying a porous component further comprises applying a glove-shaped porous component.
7. The method according to claim 1, wherein:
the limb includes a hand and wrist of the patient; and
sealing the opening includes sealing the opening to the wrist of the patient.
8. The method according to claim 1, wherein introducing the limb of the patient to the outer cover further comprises introducing the limb to a substantially air-tight outer cover.
9. The method according to claim 1, wherein applying the porous component to the limb includes applying the porous component to a hand of the limb while the hand is in at least a partially-closed position.
10. The method according to claim 1, wherein applying a porous component includes applying a porous component formed of a reticulated foam.
11. The method according to claim 1, further comprising collecting wound exudates within a canister located between the porous component and a pump used to apply the negative pressure.
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- Davydov, Yu. A., et al; “Bacteriological and Cytological Assessment of Vacuum Therapy for Purulent Wounds”; Vestnik Khirurgi, Oct. 1988, pp. 48-52, and 8 page English translation thereof.Applicant
- Davydov, Yu. A., et al; “Concepts for the Clinical-Biological Management of the Wound Process in the Treatment of Purulent Wounds by Means of Vacuum Therapy”; Vestnik Khirurqi, Jul. 7, 1980, pp. 132-136, and 8 page English translation thereof.Applicant
- Chariker, Mark E., M.D., et al; “Effective Management of incisional and cutaneous fistulae with closed suction wound drainage ”; Contemporary Surgery, vol. 34, Jun. 1989, pp. 59-63.Applicant
- Egnell Minor, Instruction Book, First Edition, 300 7502, Feb. 1975, pp. 24.Applicant
- Egnell Minor: Addition to the Users Manual Concerning Overflow Protection—Concerns all Egnell Pumps, Feb. 3, 1983, pp. 2.Applicant
- Svedman, P.: “Irrigation Treatment of Leg Ulcers”, The Lancet, Sep. 3, 1983, pp. 532-534.Applicant
- Chinn, Steven D. et al.: “Closed Wound Suction Drainage”, The Journal of Foot Surgery, vol. 24, No. 1, 1985, pp. 76-81.Applicant
- Arnljots, Björn et al.: “Irrigation Treatment in Split-Thickness Skin Grafting of Intractable Leg Ulcers”, Scand J. Plast Reconstr. Surg., No. 19, 1985, pp. 211-213.Applicant
- Svedman, P.: “A Dressing Allowing Continuous Treatment of a Biosurface”, IRCS Medical Science: Biomedical Technology, Clinical Medicine, Surgery and Transplantation, vol. 7, 1979, p. 221.Applicant
- Svedman, P. et al.: “A Dressing System Providing Fluid Supply and Suction Drainage Used for Continuous or Intermittent Irrigation”, Annals of Plastic Surgery, vol. 17, No. 2, Aug. 1986, pp. 125-133.Applicant
- N.A. Bagautdinov, “Variant of External Vacuum Aspiration in the Treatment of Purulent Diseases of the Soft Tissues,” Current Problems in Modern Clinical Surgery: Interdepartmental Collection, edited by V. Ye Volkov et al. (Chuvashia State University, Cheboksary, U.S.S.R. 1986);pp. 94-96.Applicant
- K.F. Jeter, T.E. Tintle, and M. Chariker, Managing Draining Wounds and Fistulae: “New and Established Methods,” Chronic Wound Care, edited by D. Krasner (Health Management Publications, Inc., King of Prussia, PA 1990), pp. 240-246.Applicant
- G. {hacek over (Z)}ivadinović, V. Dukić, {hacek over (Z)}. Maksimović, D. Radak, and P. Pe{hacek over (s)}ka, “Vacuum Therapy in the Treatment of Peripheral Blood Vessels,” Timok Medical Journal 11 (1986), pp. 161-164.Applicant
- F.E. Johnson, “An Improved Technique for Skin Graft Placement Using a Suction Drain,” Surgery, Gynecology, and Obstetrics 159 (1984), pp. 584-585.Applicant
- A.A. Safronov, Dissertation Abstract, Vacuum Therapy of Trophic Ulcers of the Lower Leg with Simultaneous Autoplasty of the Skin (Central Scientific Research Institute of Traumatology and Orthopedics, Moscow, U.S.S.R. 1967).Applicant
- M. Schein, R. Saadia, J.R. Jamieson, and G.A.G. Decker, “The ‘Sandwich Technique’ in the Management of the Open Abdomen,” British Journal of Surgery 73 (1986), pp. 369-370.Applicant
- D.E. Tribble, An Improved Sump Drain-Irrigation Device of Simple Construction, Archives of Surgery 105 (1972) pp. 511-513.Applicant
- M.J. Morykwas, L.C. Argenta, E.I. Shelton-Brown, and W. McGuirt, “Vacuum-Assisted Closure: A New Method for Wound Control and Treatment: Animal Studies and Basic Foundation,” Annals of Plastic Surgery 38 (1997), pp. 553-562 (Morykwas I).Applicant
- C.E. Tennants, “The Use of Hypermia in the Postoperative Treatment of Lesions of the Extremities and Thorax,” Journal of the American Medical Association 64 (1915), pp. 1548-1549.Applicant
- Selections from W. Meyer and V. Schmieden, Bier's Hyperemic Treatment in Surgery, Medicine, and the Specialties: A Manual of Its Practical Application, (W.B. Saunders Co., Philadelphia, PA 1909), pp. 17-25, 44-64, 90-96, 167-170, and 210-211.Applicant
- Non-Final Office Action date mailed Oct. 3, 2003 for U.S. Appl. No. 10/009,294.Applicant
- Response filed Mar. 2, 2004 to Non-Final Office Action date mailed Oct. 3, 2003 for U.S. Appl. No. 10/009,294.Applicant
- Non-Final Office Action date mailed Aug. 25, 2005 for U.S. Appl. No. 10/009,294.Applicant
- Response filed Nov. 25, 2005 to Non-Final Office Action date mailed Aug. 25, 2005 for U.S. Appl. No. 10/009,294.Applicant
- Final Office Action date mailed Feb. 22, 2006 for U.S. Appl. No. 10/009,294.Applicant
- Response filed Aug. 22, 2006 to Final Office Action date mailed Feb. 22, 2006 for U.S. Appl. No. 10/009,294.Applicant
- Non-Final Office Action date mailed Nov. 1, 2006 for U.S. Appl. No. 10/009,294.Applicant
- Response filed Jan. 18, 2007 to Non-Final Office Action date mailed Nov. 1, 2006 for U.S. Appl. No. 10/009,294.Applicant
- Notice of Allowance date mailed Mar. 7, 2007.Applicant
- Notice of Allowance date mailed Jun. 5, 2007.Applicant
- V.A. Solovev et al., Guidelines, The Method of Treatment of Immature External Fistulas in the Upper Gastrointestinal Tract, editor-in-chief Prov. V.I. Parahonyak (S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R. 1987) (“Solovev Guidelines”).Applicant
- V.A. Kuznetsov & N.A. Bagautdinov, “Vacuum and Vacuum-Sorption Treatment of Open Septic Wounds,” in II All-Union Conference on Wounds and Wound Infections: Presentation Abstracts, edited by B.M. Kostyuchenok et al. (Moscow, U.S.S.R. Oct. 28-29, 1986) pp. 91-92 (“Bagautdinov II”).Applicant
- V.A. Solovev, Dissertation Abstract, Treatment and Prevention of Suture Failures after Gastric Resection (S.M. Kirov Gorky State Medical Institute, Gorky, U.S.S.R. 1988) (“Solovev Abstract”).Applicant