|Número de publicación||US20070055209 A1|
|Tipo de publicación||Solicitud|
|Número de solicitud||US 11/516,216|
|Fecha de publicación||8 Mar 2007|
|Fecha de presentación||6 Sep 2006|
|Fecha de prioridad||7 Sep 2005|
|También publicado como||CA2620401A1, CN101257876A, CN101257876B, EP1922044A2, EP1922044A4, EP1922044B1, EP2708216A1, EP2898908A1, US8444612, US20100331797, US20130331822, WO2007030599A2, WO2007030599A3|
|Número de publicación||11516216, 516216, US 2007/0055209 A1, US 2007/055209 A1, US 20070055209 A1, US 20070055209A1, US 2007055209 A1, US 2007055209A1, US-A1-20070055209, US-A1-2007055209, US2007/0055209A1, US2007/055209A1, US20070055209 A1, US20070055209A1, US2007055209 A1, US2007055209A1|
|Inventores||Harish Patel, Dianne Acheson|
|Cesionario original||Patel Harish A, Dianne Acheson|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citada por (64), Clasificaciones (27), Eventos legales (2)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
This patent application claims priority to and the benefit of U.S. Provisional Patent Application No. 60/714,912, filed in the U.S. Patent and Trademark Office on Sep. 7, 2006.
1. Technical Field
The present disclosure relates to an apparatus for treating an open wound, and, more specifically, relates to a self contained wound dressing with an external portable pump system which draws wound fluids into a collection canister supported by the patient.
2. Description of Related Art
Wound closure involves the migration of epithelial and subcutaneous tissue adjacent the wound towards the center of the wound until the wound closes. Unfortunately, closure is difficult with large wounds or wounds that have become infected. In such wounds, a zone of stasis (i.e. an area in which localized swelling of tissue restricts the flow of blood to the tissues) forms near the surface of the wound. Without sufficient blood flow, the epithelial and subcutaneous tissues surrounding the wound not only receive diminished oxygen and nutrients, but, are also less able to successfully fight microbial infection and, thus, are less able to close the wound naturally. Such wounds have presented difficulties to medical personnel for many years.
Wound dressings have been used in the medical industry to protect and/or facilitate healing of open wounds. One popular technique has been to use negative pressure therapy, which is also known as suction or vacuum therapy. A variety of negative pressure devices have been developed to allow excess wound fluids, i.e., exudates to be removed while at the same time isolating the wound to protect the wound and, consequently, effect recovery time. Various wound dressings have been modified to promote the healing of open wounds.
Issues that continually need to be addressed when using a wound dressing include ease of use, efficiency of healing a wound, portability and negative pressure control capabilities. Thus, there remains a need to constantly improve negative pressure wound dressings for open wounds.
In accordance with a preferred embodiment, a wound dressing apparatus includes a wound dressing member dimensioned for positioning relative to a wound bed, a portable vacuum pump in fluid communication with the wound dressing member for applying subatmospheric pressure to facilitate removal of fluid from the wound dressing member, and being be carried by the body of a patient, and a collection canister carried by the body of the patient and in fluid communication with the vacuum pump for collecting fluids removed from the wound dressing member. Preferably, the vacuum source includes a peristaltic vacuum pump and is adapted to produce subatmospheric pressure ranging between about 20 mmHg and about 500 mmHg, more preferably, about 75 mmHg to about 125 mmHg. The collection canister may include an absorbent material to contain the fluid removed from the wound dressing member. Preferably, the apparatus also include a body support bag which is adapted for mounting to the patient. The body support bag may have a pouch for retaining at least one of the collection canister and vacuum pump.
The vacuum pump preferably includes control means to control operation thereof. A pressure sensor may be incorporated with the control means to detect pressure at a predetermined location relative to the wound dressing member, and send a corresponding signal to the control means. The control means may include a controller adapted to control or vary the output of the vacuum source. The vacuum pump preferably includes a self-contained battery.
The preferred wound dressing member includes a lower member positionable adjacent the wound bed, an upper absorbent member positionable adjacent the lower member, and a top member. The upper absorbent member comprises a material selected from the group consisting of foams, nonwoven composite fabrics, cellulosic fabrics, super absorbent polymers, and combinations thereof. The upper absorbent member may also include at least one of a medicament, an anti-infective agent, an antimicrobial, polyhexamethylene biguanide (hereinafter, “PHMB”), antibiotics, debridement agents, analgesics, healing factors, vitamins, growth factors and nutrients.
In another preferred embodiment, a wound dressing apparatus, includes a wound dressing member dimensioned for positioning relative to a wound bed, a portable vacuum pump in fluid communication with the wound dressing member for applying subatmospheric pressure to facilitate removal of fluid from the wound dressing member, and having a self contained battery for operating the vacuum pump, a collection canister in fluid communication with the vacuum pump for collecting fluids removed from the wound dressing member and a body support bag attachable to the body of the patient and having a pouch for retaining at least one of the collection canister and the vacuum pump.
A method for facilitating healing of a wound is also disclosed. The method includes the steps of positioning a wound dressing member relative to a wound bed, introducing a portable vacuum pump to be in fluid communication with the wound dressing member for applying subatmospheric pressure to facilitate removal of fluid from the wound dressing member, connecting a collection canister in fluid communication with the vacuum pump for collecting fluids removed from the wound dressing member, mounting a body support bag having a retaining pouch and positioning at least one of the collection canister and the vacuum pump into the retaining pouch of the body support bag.
Various embodiments of the subject wound dressing are described herein with reference to the drawings wherein:
The composite wound dressing apparatus of the present disclosure promotes healing of a wound via the use of an external peristaltic vacuum pump. The external peristaltic pump applies a vacuum pressure to the wound to effectively draw wound fluid or exudate away from the wound bed. The external peristaltic pump is tethered to the wound dressing and is portable, preferably, carried by the patient, which permits patient mobility. Moreover, the patient does not need to be constrained for any period of time during therapy and while exudates is being removed from the wound.
Referring now to
The base layer 106 is in direct contact with the wound bed “w”. The base layer 106 is typically porous and non-adherent. “Non-adherent” as used herein refers to a material that does not adhere to tissues in and around the wound bed. “Porous” as used herein refers to a material which contains numerous small perforations or pores which allow wound fluids of all kinds to pass through the material to the dressing layers above. The passage of wound fluid through the porous material is preferably unidirectional such that wound exudate does not flow back to the wound bed. This direction flow feature could be in the form of directional apertures imparted into the material layer, a lamination of materials of different absorption to the base layer 106 or specific material selection that encourages directional flow. Exemplary materials used as the base layer 106 include a contact layer sold under the trademark XEROFLO® by Kendall Corp, a division of TycoHealthcare.
In addition, agents such as hydrogels and medicaments could be bonded or coated to the base layer 106 to reduce bioburden in the wound, promote healing and reduce pain associated with dressing changes or removal. Medicaments include, for example, antimicrobial agents, growth factors, antibiotics, analgesics, and the like. Furthermore, when an analgesic is used, the analgesic could include a mechanism that would allow the release of that agent prior to dressing removal or change.
The layer proximal to the base layer 106 is the packing/absorbent layer 108. The packing/absorbent layer 108 is intended to absorb and capture wound fluid and exudates. Exemplary materials used as the packing/absorbent layer 108 include the antimicrobial dressing sold under the trademark KERLIX® by Kendall Corp., a division of TycoHealthcare. Those skilled in the art will recognize that the packing/absorbent layer 108 can be formed into any suitable shape. The only requirement as to shape is that the packing/absorbent layer 108 is suitable to conform to a particular shape of the wound.
A further use for the packing/absorbent layer 108 is to decrease the incidence of infection in the wound bed. Hence, the packing/absorbent layer 108 may be treated with medicaments. Medicaments include, for example, an anti-infective agent such as an antiseptic or other suitable antimicrobial or combination of antimicrobials, polyhexamethylene biguanide (hereinafter, “PHMB”), antibiotics, analgesics, healing factors such as vitamins, growth factors, nutrients and the like, as well as a simple flushing with isotonic saline solution.
With continued reference still to
The top layer 110 is preferably in the form of a sheet mounted proximal to the packing/absorbent layer 108. In a preferred embodiment, the peripheral portions 110P of the top layer 110 includes an adhesive and is secured to the tissue “t” about the wound bed “w”. The peripheral portions 110P may be secured to the periphery of base layer 102 if desired. It is anticipated that removable liners may also be used to protect the adhesive surface of the top layer 110 prior to use.
The top layer 110 may incorporate a flexible material, e.g., resilient or elastomeric, that seals the top of the wound dressing 102. In one embodiment, the top layer 110 includes the transparent dressing manufactured under the trademark Polyskin II® by Kendall Corp, a division of TycoHealthcare. POLYSKIN® II is a transparent, semi-permeable material which permits moisture and oxygen exchange with the wound site, and provides a barrier to microbes and fluid containment. In the alternative, the top layer 110 may be impermeable. The transparency of the top layer 110 provides a visual indication of the status of the wound dressing and more particularly, the status of the saturation level of the layers of the wound dressing. The top layer 110 further includes a vacuum port or connector 112 in fluid communication with the interior of the wound dressing 102. The vacuum port 112 may be a separate component attached to the top layer 110 and connected thereto by conventional means or integrally formed with the top layer 110. The vacuum port 112 may have a valve built therein, e.g., a one way valve, to permit exudates to flow in one direction only, i.e., away from the wound dressing 102 toward the pump system 104. Vacuum port 112 is adapted to be releasably connected to the pump system 104 as will be discussed and may or may not include structure for releasable connection to the pump system.
Referring still to
The inlet and outlet tubings 116,120 may be any suitable flexible tubing fabricated from elastomeric and/or polymeric materials. The inlet tubing 116 is preferably releasably connected to the vacuum port 112 through conventional means including a friction fit, bayonet coupling, snap fit or the like. The collection canister 118 may be any flexible disposable pouch or the like. The collection canister 118 may include a super absorbent material such as superabsorbent polymers (SAP), silica gel, sodium polyacrylate, potassium polyacrylamide and related compounds to consolidate or contain wound drainage or debris. The collection canister 118 is preferably transparent to permit viewing into the interior of the canister 118 to assist the patient in determining the remaining capacity of the collection canister 118 and quality of exudates.
With reference now to
In use, the wound dressing apparatus 100 is positioned within the wound bed “w” as shown in
Once the wound is fully healed, the wound closure apparatus and pump system may be disposed. The body support bag may also be disposed or cleaned for subsequent use. The pump may be sterilized and reused as well.
Absorbent layer 204 is preferably a foam filled dressing which is transparent. The foam may be a resilient, liquid absorbent, porous, polymer-based foam. The foam may be a dispensable liquid which at least partially solidifies to a crystal-like arrangement defining hollow tubes to allow exudates drainage. The foam is dispensed within the wound bed and is potentially collapsible to expel air from the foam channels. The foam may be an expandable hydrophilic foam which is capable of absorbing fluid from a wound and maintain the wound bed moist. The hollow tubes or voids defined by the foam also provide a means to conduct electricity, heat, cold, and ultrasound. The hollow tubes or voids also provide a bioactive scaffold for tissue growth. A thin film transparent top layer 205 is secured about the wound area to enclose the wound.
The self contained battery source and control circuitry may be mounted within housing 206 which is connected to belt 208. Belt 208 is adapted for mounting to the body of a patient, e.g., around the waist area and may include VELCRO® means for securing about the patient. Belt 208 may further support canister 210 which receives the fluid exudates from pump 202 through tube 212. Tube 214 extends from housing 206 to pump 202 and may incorporate electronic wires etc. for operating the pump. In the alternative, tube 212 may incorporate the electrical wires within, e.g., a lumen, and extend from the housing to pump 202 and canister 210.
It is further contemplated that the wound dressing apparatus may incorporate external means or applications to stimulate tissue growth and/or healing. For example, an auxiliary treatment apparatus may be incorporated into the wound dressing apparatus to impart electrical or mechanical energy for the treatment of the tissue such as, for instance, directing electrical, thermal or vibratory energy on the wound area and/or introducing various drugs into the human body through the skin. The auxiliary treatment apparatus may be incorporated into the housing of the pump 202 as shown schematically as reference numeral 216 and operated via a control means discussed hereinabove. One suitable auxiliary treatment apparatus may include an ultrasonic transducer. Other sensor types are also contemplated for incorporation into the wound dressing apparatus including oxygen, chemical, microbial and/or temperature sensors. The detection of oxygen adjacent the wound area would assist the clinician in determining the status of wound healing. The presence of an elevated temperature may be indicative of an infection. The pump system may incorporate circuitry to communicate with a computer, e.g., a hand-held PALM® device through wireless means.
While the disclosure has been illustrated and described, it is not intended to be limited to the details shown, since various modifications and substitutions can be made without departing in any way from the spirit of the present disclosure. For example, it is envisioned the subject matter of the commonly assigned patent application filed concurrently herewith under Express Mail Certificate No. EL 985194511 US, and which claims priority to provisional application No. 60/714,812, filed on Sep. 6, 2006, and the subject matter of the commonly assigned patent application filed concurrently herewith under Express Mail Certificate No. EL 985194499, and which claims priority to provisional application No. 60/714,805, filed on Sep. 7, 2006, (the entire contents of each application being incorporated herein) may be incorporated into the present disclosure. As such, further modifications and equivalents of the invention herein disclosed can occur to persons skilled in the art using no more than routine experimentation, and all such modifications and equivalents are believed to be within the spirit and scope of the disclosure as defined by the following claims.
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|Clasificación de EE.UU.||604/315, 604/319|
|Clasificación cooperativa||A61M1/0096, A61F13/00063, A61F2013/0074, A61M2205/15, A61F2013/0054, A61F2013/00536, A61M1/0066, A61M1/0031, A61F2013/00748, A61F2013/00412, A61F2013/0091, A61M2209/08, A61M2205/3344, A61M2205/8206, A61F2013/00174, A61F13/00068, A61M1/0088, A61M27/00, A61M1/0072|
|Clasificación europea||A61F13/00B8, A61M1/00P, A61M1/00T6, A61M27/00, A61F13/00B6|
|15 Nov 2006||AS||Assignment|
Owner name: TYCO HEALTHCARE GROUP LP, MASSACHUSETTS
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:PATEL, HARISH A.;ACHESON, DIANNE;REEL/FRAME:018729/0084;SIGNING DATES FROM 20061012 TO 20061109
|18 Abr 2013||AS||Assignment|
Owner name: COVIDIEN LP, MASSACHUSETTS
Free format text: CHANGE OF NAME;ASSIGNOR:TYCO HEALTHCARE GROUP LP;REEL/FRAME:030248/0692
Effective date: 20120928