|Número de publicación||US20060213527 A1|
|Tipo de publicación||Solicitud|
|Número de solicitud||US 11/440,758|
|Fecha de publicación||28 Sep 2006|
|Fecha de presentación||25 May 2006|
|Fecha de prioridad||14 Nov 1991|
|También publicado como||US7198046, US7216651, US20010029956|
|Número de publicación||11440758, 440758, US 2006/0213527 A1, US 2006/213527 A1, US 20060213527 A1, US 20060213527A1, US 2006213527 A1, US 2006213527A1, US-A1-20060213527, US-A1-2006213527, US2006/0213527A1, US2006/213527A1, US20060213527 A1, US20060213527A1, US2006213527 A1, US2006213527A1|
|Inventores||Louis Argenta, Michael Morykwas|
|Cesionario original||Argenta Louis C, Morykwas Michael J|
|Exportar cita||BiBTeX, EndNote, RefMan|
|Citada por (32), Clasificaciones (32)|
|Enlaces externos: USPTO, Cesión de USPTO, Espacenet|
The present invention relates to an apparatus and method for treating a wound by applying reduced pressure to the wound.
The treatment of open wounds that are too large to spontaneously close has long been a troublesome area of medical practice. Closure of an open wound requires inward migration of surrounding epithelial and subcutaneous tissue. Some wounds, however, are sufficiently large or infected that they are unable to heal spontaneously. In such instances, a zone of stasis in which localized edema restricts the flow of blood to the epithelial and subcutaneous tissue forms near the surface of the wound. Without sufficient blood flow, the wound is unable to successfully fight bacterial infection and is accordingly unable to close spontaneously.
An initial stage of wound healing is characterized by the formation of granulation tissue which is a matrix of collagen, fibronectin, and hyaluronic acid carrying macrophages, fibroblasts, and neovasculature that forms the basis for subsequent epithelialization of the wound. Infection and poor vascularization hinder the formation of granulation tissue within wounded tissue, thereby inhibiting wound healing. It therefore becomes desirable to provide a technique for increasing blood circulation within wounded tissue to promote spontaneous healing and to reduce infection.
Poor blood circulation and infection at the wound may also hinder attachment of skin grafts or flaps upon wounded tissue. Skin grafts and flaps will not attach to tissue that is poorly vascularized, infected or necrotic. However, grafts and flaps can be used with much greater success on tissue that, although wounded, is able to form granulation tissue. Accordingly, a technique for promoting blood circulation at the wounded tissue would also promote successful attachment, or “take,” of skin grafts or flaps to the wounded tissue as a consequence of increased blood circulation within the grafts or flaps.
Another problem encountered during the treatment of wounds is the selection of an appropriate technique for wound closure during the healing process. Sutures are often used to apply force to adjacent viable tissue in order to induce the edges of a wound to migrate together and heal. However, sutures apply a closure force to only a very small percentage of the area surrounding a wound. When there is scarring, edema, or insufficient tissue, the tension produced by the sutures can become great causing excessive pressure to be exerted by the sutures upon the tissue adjacent to each suture. As a result, the adjacent tissue often becomes ischemic thereby rendering suturing of large wounds counterproductive. If the quantity or size of the sutures is increased to reduce the tension required of any single suture, the quantity of foreign material within the wound is concomitantly increased and the wound is more apt to become infected. Additionally, the size or type of a particular wound may prevent the use of sutures to promote wound closure. It therefore becomes desirable to provide an apparatus and method for closing a large wound that distributes a closure force evenly about the periphery of the wound.
Wounds resulting from ischemia, or lack of blood flow, are also often difficult to heal since decreased blood flow to a wound may inhibit normal immune reaction to fight infection. Patients that are bedridden or otherwise non-ambulatory are susceptible to such ischemic wounds as decubitus ulcers or pressure sores. Decubitus ulcers form as a result of constant compression of the skin surface and underlying tissue thus restricting circulation. Since the patient is often unable to feel the wound or to move sufficiently to relieve the pressure, such wounds can become self-perpetuating. Although it is common to treat such wounds with flaps, the conditions that initially caused the wound may also work against successful flap attachment. Wheelchair-bound paraplegics, for example, must still remain seated after treatment of pelvic pressure sores. It therefore becomes desirable to provide a treatment procedure for ischemic wounds that can be conducted in situ upon an immobile or partially mobile patient.
Other types of wounds in which ischemia leads to progressive deterioration include partial thickness burns. A partial thickness burn is a burn in which the cell death due to thermal trauma does not extend below the deepest epidermal structures such as hair follicles, sweat glands, or sebaceous glands. The progression of partial thickness burns to deeper burns is a major problem in burn therapy. The ability to control or diminish the depth of burns greatly enhances the prognosis for burn patients and decreases morbidity resulting from burns. Partial thickness burns are formed of a zone of coagulation, which encompasses tissue killed by thermal injury, and a zone of stasis. The zone of stasis is a layer of tissue immediately beneath the zone of coagulation. Cells within the zone of stasis are viable, but the blood flow is static because of collapse of vascular structures due to localized edema. Unless blood flow is re-established within the zone of stasis soon after injury, the tissue within the zone of stasis also dies. The death of tissue within the zone of stasis is caused by lack of oxygen and nutrients, reperfusion injury (re-establishment of blood flow after prolonged ischemia), and decreased migration of white blood cells to the zone resulting in bacterial proliferation. Again, it becomes desirable to provide a technique for treating burn wounds by enhancing blood-circulation to the wounded tissue to inhibit burn penetration.
In accordance with the present invention a wound treatment apparatus is provided for treating a wound by applying reduced pressure (i.e. pressure that is below ambient atmospheric pressure) to the wound in a controlled manner for a selected time period. The application of reduced pressure to a wound provides such benefits as faster healing, increased formation of granulation tissue, closure of chronic open wounds, reduction of bacterial density within wounds, inhibition of burn penetration, and enhancement of flap and graft attachment. Wounds that have exhibited positive response to treatment by the application of negative pressure include infected open wounds, decubitus ulcers, dehisced incisions, partial thickness burns, and various lesions to which flaps or grafts have been attached.
The wound treatment apparatus in accordance with the present invention includes a reduced pressure application appliance which is applied to a treatment site at which there is a wound and normal tissue surrounding the wound. The reduced pressure application appliance includes a fluid impermeable wound cover for covering and enclosing the wound. The appliance also includes sealing means for sealing the wound cover to the surrounding tissue of the wound in order to maintain reduced pressure in the vicinity of the wound during wound treatment. When the wound cover is sealed in position over the wound site, a generally fluid-tight or gas-tight sealed enclosure is formed over the wound site. The sealing means may be in the form of an adhesive applied to the underside of the wound cover for sealing the wound cover around the periphery of the wound. The sealing means may also include a separate sealing member such as an adhesive strip or a sealing ring in the form of a tubular pad or inflatable cuff secured to the wound cover for positioning around the periphery of the wound. In selected embodiments, the reduced pressure within the sealed enclosure under the wound cover may serve to seal the wound cover in position at the wound site. The reduced pressure appliance also includes a suction port for supplying reduced pressure within the sealed volume enclosed beneath the wound cover. The suction port may be in the form of a nipple on the wound cover. Alternatively, the suction port may be in the form of a tube attached to the wound cover or provided as a feedthrough beneath the wound cover. The appliance may also include a porous wound screen for placement in the wound or in position overlying the wound in order to prevent overgrowth of wound tissue during treatment. The wound screen is sufficiently porous to permit gas flow to the wound. The porous wound screen may be in the form of a sponge or open-cell foam material for placement in the wound. The porous screen may also include a rigid or semi-rigid screen for overlying the wound.
A vacuum system is connected with the reduced pressure appliance in order to provide suction or reduced pressure to the appliance. For this purpose, the vacuum system includes a suction pump or suction device for connection with the suction port of the appliance for producing the reduced pressure over the wound site. The vacuum system may include a section of hose or tube, such as a vacuum hose, that interconnects the suction device with the suction port of the appliance to provide the reduced pressure at the wound site. A collection device in the form of a fluid trap may be provided intermediate the vacuum hose of the suction device and the suction port of the appliance to trap any exudate which may be aspirated from the wound by the negative pressure appliance. A stop mechanism may also be provided for the vacuum system to halt production of the reduced pressure at the wound site in the event that an excessive quantity of exudate has been collected. The apparatus may also include a control device for controlling the pump and for providing intermittent or cyclic production of reduced pressure.
In a particular embodiment of the invention, the wound cover for the reduced pressure appliance may be in the form of a gas impermeable covering sheet of flexible polymer material, such as polyethylene, having an adhesive backing that provides the seal for securing the sheet over the wound site to provide an gas-tight or fluid-tight sealed enclosure over the wound site. The vacuum system of the wound treatment apparatus may include a suction pump having a vacuum hose that is connected with a suction tube serving as a suction port for the appliance. The suction tube for the appliance runs beneath the cover sheet that is sealed in position over the wound site and into the fluid-tight enclosure provided under the cover sheet. An adhesive backing on the cover sheet is used to provide a fluid-tight seal around the feedthrough for the suction tube at the wound site. Within the enclosure, the suction tube is connected with a piece of open-cell foam for placement in the wound. The open-cell foam functions to more uniformly apply reduced pressure or suction over the wound site while holding the cover sheet substantially out of the wound during the application of reduced pressure at the enclosed wound site.
In operation, a method of treating tissue damage is provided which comprises applying a negative or reduced pressure to a wound over an area sufficient to promote the migration of epithelial and subcutaneous tissue toward the wound and for a time period sufficient to facilitate closure of the wound. The method is useful for treating pressure sores.
A method of treating a burn wound is also provided which comprises applying a negative or reduced pressure to the burn over an area and for a time sufficient to inhibit progression in the depth of the burn. The method is useful on a partial thickness burn soon after its infliction.
A method of treating tissue damage is also provided which comprises applying a negative or reduced pressure to a wound for a time sufficient to reduce bacterial density in the wound. One use of this method is its application to a wound for a selected time period such as at least three days to reduce the bacterial density of an infected wound to the point at which surgical closure can be attempted.
Another aspect of the invention is a method of enhancing the attachment of adjacent tissue to a wound which comprises applying negative or reduced pressure to a joined complex of the adjacent living tissue and the wound at a sufficient magnitude of reduced pressure and for a sufficient time duration to promote the migration of epithelial and subcutaneous tissue toward the complex. This method enhances attachment of adjacent tissue to tissues of the wound edges. Another use of this method is to enhance attachment of an open skin graft to the wound tissue.
The foregoing summary, as well as the following detailed description of the preferred embodiments of the present invention, will be better understood when read in conjunction with the appended drawings, in which:
In accordance with the present invention, a wound treatment apparatus is provided for treating a wound by application of reduced pressure (i.e., below atmospheric pressure) so that suction may be applied to a wound site in a controlled manner for a selected time period. As schematically shown in
The appliance 600 includes a substantially flat section of open cell polyester foam section 610 (Fischer Scientific, Pittsburgh, Pa. 15219) sufficiently large to cover the wound and thus prevent wound overgrowth, a flexible hollow tube 611 (Fischer Scientific) inserted into the open cell foam section 610 and joined thereto with an adhesive and extending to attach at its opposite end with a Gast Vacuum pump (Fischer Scientific), and an Ioban adhesive sheet 612 (Minnesota Mining and Manufacturing, St. Paul, Minn. 55144) overlying the foam section 610 and tubing 611 and adhered to the skin surrounding the wound, thus forming a seal that allows creation of a vacuum when the suction pump operates. Such an appliance 600 would most preferably be packaged in a sterile condition to ameliorate the need for sterilization of the apparatus prior to use. The adhesive sheet 612 may be packaged separately from the foam-tube assembly 610 and 611. A particular advantage of this configuration is its use with pressure sores because the device can be placed in the depths of the wound and the patient can lie upon the device without either affecting the utility of the device or further damaging the wound. This becomes critical if the patient cannot be moved from this posture for medical or other reasons.
As shown in
The appliance 29 also includes a porous wound screen 10 which is placed within the wound 24. The wound screen 10 is placed over substantially the expanse of the wound to prevent its overgrowth. The size and configuration of the wound screen 10 can be adjusted to fit the individual wound. It can be formed from a variety of porous materials. The material should be sufficiently porous to allow oxygen to reach the wound. The wound screen 610 may be in the form of an open-cell polymer foam, such as a polyurethane foam, which is sufficiently porous to allow gas flow to and/or from the wound 24. Foams may be used that vary in thickness and rigidity, although it may be desirable to use a spongy material for the patient's comfort if the patient must lie upon the appliance during treatment. The foam may also be perforated to enhance gas flow and to reduce the weight of the appliance. As shown in
The appliance 29 also includes a suction port in the form of a hollow suction tube 12 that connects with the vacuum system 30 to provide suction within the sealed enclosure. The suction tubing 12 serves as a suction port for appliance 29. An end segment 12 a of the tubing 12 is embedded within the foam screen 10 for providing suction or reduced pressure within the enclosure provided under the wound cover 18. Embedding the open end of segment 12 a of tubing 12 within the interior of the foam screen 10 permits the foam screen 10 to function as a shield to help prevent the wound cover 18 from being inadvertently sucked into sealing engagement with the open end of the tube thereby plugging the tube 12 and restricting gas flow. The tube segment 12 a embedded within the foam screen 10 preferably has at least one side port 14 for positioning within the interior of the foam screen 10 to promote substantially uniform application of reduced pressure throughout the enclosure. Positioning the side port 14 of tube segment 12 a within the interior of the foam screen 10 permits the foam screen 10 to function as a shield for the side port to thereby prevent the wound cover 18 from being sucked into the side port 14 and thereby restricting gas flow. The open cells of the foam screen 10 facilitate gas flow throughout the enclosure. In addition, the foam screen 10 functions to prevent wound overgrowth and to hold the wound cover 18 generally out of contact with the wound 24 during the application of suction within the enclosure.
Tubing 12 and tube segment 12 a are sufficiently flexible to permit movement of the tubing but are sufficiently rigid to resist constriction when reduced pressure is supplied to the appliance 29 or when the location of the wound is such that the patient must sit or lie upon the tubing 12 or upon the reduced pressure appliance 29. The screen-tube assembly comprising the foam screen 10 and the tube 12 may be fabricated by snaking the end of the tube segment 12 a through an internal passageway in the foam screen 10 such as by pulling the end of the tube segment 12 a through the passageway using forceps. Alternatively, fabrication of the screen-tube assembly may be accomplished by suspending the end of the tube segment 12 a into a suitable mold or form and then blowing foam into the mold or form to embed the tube end segment 12 a within the blow-molded foam screen. The screen-tube assembly 12 and 10 is preferably prepared prior to use under sterile conditions and then stored in an aseptic package.
In order to use the reduced pressure appliance 29 at the site of the wound 24, the flexible, gas-impermeable, adhesive wound cover sheet 18 is secured in position at the wound site overlying the foam screen 10 disposed within the wound 24. The wound cover sheet 18 is secured and sealed to the surrounding normal skin 22 by an adhesive layer 20 on the under surface of the wound cover 18 to form a gas-tight seal 19 around the periphery of the wound 24. The wound cover 18 also provides a gas-tight seal around the tubing 12 at the feedthrough location 22 a where the tubing 12 emerges from beneath the wound cover 18. The wound cover 18 is preferably formed of a fluid impermeable or gas impermeable flexible adhesive sheet such as Ioban, a product of the 3M corporation of Minneapolis, Minn.
The vacuum system 30 includes a suction pump 40 that produces a source of reduced pressure or suction which is supplied to the reduced pressure appliance 29 by suction tubing 12. As shown in
Predetermined amounts of suction or reduced pressure are produced by the vacuum pump 40. The vacuum pump 40 is preferably controlled by a control device 44 such as a switch or a timer which may be set to provide cyclic on/off operation of the vacuum pump 40 according to user-selected intervals. Alternatively, the vacuum pump 40 may be operated continuously without the use of a cyclical timer.
The vacuum system 30 preferably includes a shut-off mechanism for halting or inhibiting the supply of the reduced pressure to the appliance 29 in the event that the exudate aspirated from the wound 24 exceeds a predetermined quantity. Interrupting the application of suction to the appliance 29 is desirable to prevent exsanguination in the unlikely event a blood vessel ruptures under the wound cover 18 during treatment. If, for example, a blood vessel ruptures in the vicinity of the wound 24, a shut-off mechanism would be useful to prevent the vacuum system 30 from aspirating any significant quantity of blood from the patient. As a safety feature, various mechanical or electrical detection mechanisms may be employed to detect the level of exudate in the fluid trap 28.
As shown in
Other types of mechanisms may be employed to detect the liquid level within the fluid trap 28 in order to arrest operation of the vacuum source. An alternative vacuum system 30 a is shown in
Other types of detection devices may also be employed to detect a predetermined level of liquid collected in collection vessel 33. For example, collection of exudate in excess of a predetermined quantity may enable actuation of an electronic switch which turns off the vacuum pump or otherwise halts the supply of suction to the reduced pressure appliance 29. Referring to
For the purpose of protecting the site of a wound from impact or abrasion during treatment, a reduced pressure appliance employing a rigid or semi-rigid wound cover may be utilized over the site of the wound. As shown in
As shown in
For applications where a downward pressure of the appliance into a wound is not desired, a reduced pressure appliance 29 e, as shown in
Negative pressure appliances are useful for treating a variety of wounds. Treatment of a wound can be carried out by securing a negative pressure appliance to the treatment site as previously shown and described, and then maintaining a substantially continuous or cyclical reduced pressure within the appliance until the wound has reached a desired improved condition. A selected state of improved condition may include formation of granulation tissue sufficient for the attachment of a flap or graft, reduction of microbial infection in the wound, arrest or reversal of burn penetration, closure of the wound, integration of a flap or graft with the underlying wounded tissue, complete healing of the wound, or other stages of improvement or healing appropriate to a given type of wound or wound complex. It may be preferable to change the appliance periodically, such as at 48 hour intervals, during treatment, particularly when using appliances incorporating a screen on or in the wound. The method is preferably practiced using a negative or reduced pressure ranging from 0.01 to 0.99 atmospheres, and more preferably practiced using a negative or reduced pressure ranging between 0.5 to 0.8 atmospheres. The time period for use of the method on a wound may preferably be at least 12 hours, but can be, for example, extended for one or more days. There is no upper limit beyond which use of the method is no longer beneficial; the method increases the rate of closure up to the time the wound actually closes. Satisfactory treatment of various types of wounds has been obtained via the use of reduced pressures equivalent to about 2 to 7 in. Hg below atmospheric pressure.
Supplying reduced pressure to the appliance in an intermittent or cyclic manner has also been demonstrated to be useful for treating wounds. Intermittent or cyclic supply of reduced pressure to an appliance may be achieved by manual or automatic control of the vacuum system. A cycle ratio, the ratio of “on” time to “off”1 time, in such an intermittent reduced pressure treatment may be as low as 1:10 or as high as 10:1. The preferred ratio is approximately 1:1 which is usually accomplished in alternating 5 minute intervals of reduced pressure supply and non-supply.
A suitable vacuum system includes any suction pump capable of providing at least 0.1 pounds of suction to the wound, and preferably up to three pounds suction, and most preferably up to fourteen (14) pounds suction. The pump can be any ordinary suction pump suitable for medical purposes that is capable of providing the necessary suction. The dimension of the tubing interconnecting the pump and the reduced pressure appliance is controlled by the pump's ability to provide the suction level needed for operation. A ¼ inch diameter tube may be suitable.
The present invention also includes a method of treating damaged tissue which comprises the steps of applying negative pressure to a wound for a selected time and at a selected magnitude sufficient to reduce bacterial density in the wound. Open wounds are almost always contaminated with harmful bacteria. Generally a bacterial density of 105 bacterial organisms per gram of tissue is regarded as infected. It is generally accepted that at this level of infection, grafted tissue will not adhere to a wound. These bacteria must be killed, either through the wound host's natural immune response or through some external method, before a wound will close. The application of negative pressure to a wound appears to reduce the bacterial density of the wound. It is believed that this effect is due to either the bacteria's incompatibility with a negative pressure environment or the increased blood flow to the wound area, as blood brings with it cells and enzymes to destroy the bacteria. The method can be used to reduce bacterial density in a wound by at least half. More preferably, it can be used to reduce bacterial density by at least 1,000 fold. Most preferably, the method can be used to reduce bacterial density by at least 1,000,000 fold.
The present invention also includes a method of treating a burn which comprises the steps of applying negative pressure to the burn over an area with predetermined reduced pressure and for a time sufficient to inhibit formation of a full thickness burn. A partial thickness burn, one which has a surface layer of dead tissue and an underlying zone of stasis, is often sufficiently infected so that it will transform within 24-48 hours into a full thickness burn, one in which all epidermal structures are destroyed. The application of negative pressure to the wound prevents the infection from becoming sufficiently severe to cause destruction of the underlying epidermal structures. The magnitude, pattern, and duration of pressure application can vary with the individual wound.
The present invention also provides a method for enhancing the attachment of living tissue to a wound which comprises the steps of first joining the living tissue to the wound to form a wound-tissue complex, then applying a negative or reduced pressure of selected magnitude to the wound-tissue complex over an area sufficient to promote migration of epithelia and subcutaneous tissue toward the complex, with the negative pressure being maintained for a selected time period sufficient to facilitate closure of the wound. Attachment of living tissue to a wound is a common procedure that can take many forms. For example, one common technique is the use of a “flap,” a technique in which skin tissue from an area adjacent to the wound is detached on three sides but remains attached on the fourth, then is moved onto the wound. Another frequently used technique is an open skin graft in which skin is fully detached from another skin surface and grafted onto the wound. The application of negative pressure to the wound-graft complex reduces bacterial density in the complex and improves blood flow to the wound, thereby improving the attachment of the grafted tissue. Further features of the apparatus and methods for the use thereof shall be made apparent in the following examples.
In order to demonstrate the use of a negative pressure appliance in the treatment of open wounds, an animal study was conducted using pigs as subjects. Pigs are frequently used as subjects in wound healing studies since they have essentially the same skin and subcutaneous tissue structure as humans.
Five 15 kg Chester pigs were obtained and acclimated for 1 week prior to use. The animals were sedated with an intramuscular injection of ketamine (25 mg/kg): xylazine (2.5 mg/kg): acepromazine (5 mg/kg). The backs and sides of the animals were shaved and scrubbed for surgery. One percent halothane was administered by endotracheal tube for maintenance of anesthesia. Two circular wounds were created on the midline of the animals. The wounds were 2.5 cm in diameter having a depth reaching, but not including, the deep fascia over the spine (approximately 1 cm). Wounds in pigs in this site do not contract during healing. Alginate impressions were made of each wound to determine the volumes of the wounds.
A reduced pressure appliance of the type discussed in connection with
The animals were sedated 48 hours after surgery as described above, and then daily thereafter, so that alginate impressions could be made of each wound. This routine was continued until the wounded areas were filled with granulation tissue until coplanar with the surrounding tissue. The results of this experiment, including time to complete filling of the wound space by granulation tissue and the rate of granulation tissue formation, are presented in Table 1. The data in the third column of Table 1 shows the number of days needed for the treated and non-treated wounds to heal. In order to allow comparisons between the healing rate of variously-sized wounds, the data in the fourth column is expressed as a healing rate in terms of cc granulation tissue per day. As can be seen, the treated wounds exhibited higher rates of healing than did the non-treated wounds. The wounds treated with reduced pressure filled with granulation tissue at an average rate that was 52.3% greater than the rate of granulation of the control wounds. Animals numbered 1 and 2 experienced intermittent loss of reduced pressure throughout the experiment, yet the treated wounds of these animals also healed significantly faster than their control wounds.
TABLE 1 Initial Days % Rate Wound to Fill Increase Volume Full Rate Due to Animal Wound (cm3) Granulation (cm3/day) Treatment #1 Control 4.9 13 0.38 26.3 Treated 5.3 11 0.48 #2 Control 7.2 8 0.90 28.9 Treated 9.3 8 1.16 #3 Control 4.0 12 0.33 75.8 Treated 3.5 6 0.58 #4 Control 4.7 11 0.43 65.1 Treated 5.0 7 0.71 #5 Control 4.7 11 0.43 65.1 Treated 5.1 7 0.71 Average — — — — 52.3
During the course of the experiment described as Example 1 above, it was observed that the reduced pressure-treated wounds were much cleaner and bled more spontaneously than non-treated wounds. It was therefore undertaken to determine the relative rates of clearance of a known bacterial inoculum from treated and non-treated wounds.
Five 15 kg pigs were obtained and wounds created as set forth in Example 1. Two 2.5 cm diameter defects were created on the dorsum of each pig using a sterile technique, with a 7.5 cm interval retained between the edges of the defects. Hemostasis was obtained by electrocautery. Prior to placement of the reduced pressure appliances, 10 8 organisms of Staphylococcus aureus in 1 ml saline solution were injected into each wound. The reduced pressure appliances of the type shown in
The biopsy samples were weighed and sterile saline (99X biopsy weight) added. The tissue samples were homogenized in a tissue grinder and serial dilutions were made in triplicate. 100 microliters of each dilution was plated on a blood agar plate and incubated overnight. The number of colonies were counted on each plate and thus the number of organisms per gram of tissue was calculated. The data was recorded as the common logarithm of the number of organisms/gram tissue and is shown in Table 2.
TABLE 2 Average Log14 (organisms/gm) Day Day Day Day Day Day Day 0 1 2 3 4 5 7 Control 8.44 8.04 8.17 7.13 7.13 8.82 7.08 Treated 7.69 7.36 7.37 6.79 6.43 3.98 4.32
As can be seen in Table 2, the common logarithm of the average number of organisms per gram of tissue present in the treated and non-treated wounds decreased slightly for all five animals over the first 4 days. In the treated wounds, the mean log of organisms/gm decreased dramatically between days 4 and 5. The mean log of organisms/gm within the non-treated wounds increased during the same period. Using the traditional baseline of 105 organisms/gm to define infection, the data of Table 2 shows that the average treated wound was disinfected after four days of treatment while the average non-treated wound was still infected after 7 days.
Use of reduced pressure appliances upon burns has been found to retard the progression of partial thickness burns into full thickness burns. A partial thickness burn is a burn in which the depth of cell death due to thermal trauma does not extend below the level of the deepest epidermal structures (i.e., the base of hair follicles, sweat glands, sebaceous glands, etc.). A burn that is initially a partial thickness burn will often deepen and progress into a full thickness burn due to insufficient blood circulation to the epidermal cells beneath the partial burn.
The backs of five 15 kg pigs were shaved and scrubbed for surgery. A 1.5 inch diameter brass rod was heated to 190° C. in an oil bath. The rod was pressed onto the pig's skin for 15 seconds following a well-known technique of relating depth of burn to time and temperature. Three burns were created over the spine of each pig, separated by 5 cm intervals. Suction apparatus cups of the configuration shown in
Biopsies were analyzed by a dermatopathologist who was not told the nature of the study. It was concluded that the suctioned tissue specimens were healthier and healing more quickly than non-suctioned specimens.
A set of 2 cm diameter standardized depth partial thickness burns were created by pressing a heated metal rod to each side of five anesthetized pigs to create 16 burns on each side of each pig. Reduced pressure appliances of the type shown in
The Breslow Level (maximum total depth) for the burns treated by reduced pressure was 0.095 mm. The maximum depth of the burns which were not treated by reduced pressure was 0.885 mm. The use of reduced pressure appliances thus resulted in a 112% reduction in the maximum depth of burn progression.
Patient B. is admitted with second and third degree burns over the face and upper extremities, including both hands, as a result of a house fire. A large mitten-shaped reduced pressure appliance of the general type shown in
In order to determine the effect of reduced pressure application upon skin flap survival, five 15 kg Chester pigs were obtained and acclimated for 1 week as described previously. Two dorsally-based 3 cm by 12 cm flap outlines were drawn using indelible ink on each side of the pigs, leaving 6 cm between each flap. The flaps were assigned to one of four groups as follows:
(1) Dual-treated flaps are flaps that were exposed to reduced pressure both prior to and following surgery;
(2) Pre-treated flaps are flaps that were exposed to reduced pressure prior to surgery, but were not exposed to reduced pressure after surgery;
(3) Post-treated flaps are flaps that were exposed to reduced pressure following surgery; and
(4) Control flaps are flaps that were not exposed to reduced pressure either pre- or post-surgery.
The pre-treated flaps were initially treated by covering an area surrounding one of the flap outlines on the left side of each animal with a reduced pressure appliance of the type shown in
On the day of surgery, each pig was sedated as previously described and anesthesia was maintained by 1% halothane. Two 3 cm by 12 cm dorsally based flaps were created on each side of the pig following the flap outlines. The flaps were created at a depth immediately below the panniculus carnosus (a subcutaneous muscle layer). The flaps were raised and then sutured back in place with single, interrupted sutures of 3-0 nylon. The reduced pressure appliances were then placed over the anterior flaps on each side of the animal. A reduced pressure of 5-7 pounds was continuously applied to the anterior flaps. Each suction tube ran from the appliances on the animals upward through a pulley suspended over the pens and down to a vacuum trap bottle to collect any liquid exudate. A hose was connected from each vacuum trap bottle to a vacuum pump to supply the reduced pressure to the appliances. The animals had free access to all areas of the pen.
The animals were anesthetized 72 hours after surgery and the appliances were removed. Photographs of each side of the animals were taken, and tracings of the flaps (and encompassing any discolored areas) were made on acetate to allow for planimetric calculation of percent survival. The appliances were then replaced and reduced pressure re-applied. This routine was continued at 48 hour intervals until no further necrosis or healing of the flaps was observed.
The distal portions of all flaps were discolored 72 hours post surgery, with the flaps exposed to reduced pressure being lighter in color. The distal ends of all flaps appeared to necrose and an eschar formed over the distal portion of each flap. Over time the eschar spontaneously desquamated, exposing the outline of the original flap. The eschar over the control and pre-treated flaps consistently desquamated sooner than the post-treated and the dual-treated flaps. The control flaps had contracted to a Y shape which was evident after the eschar had desquamated. The dual-treated flaps had contracted slightly and appeared as long, thin rectangles after dislodgement of the eschar. The pre-treated flaps and post-treated flaps were intermediate between the control and dual-treated flaps in regard to flap contraction.
Dual-treated flaps exhibited the greatest survival in terms of percent retention (72.2%) of the original flap size. The post-treated flaps had the second greatest survival (67.4%). The pretreated flaps had the third most flap survival (64.8%). The control flaps had the least flap survival (51.2%). All treated flaps (dual-treated; pre-treated; and post-treated) exhibited significantly greater surface area survival than the control flaps. The dual-treated flaps had significantly greater surface area survival than either the pre-treated or post-treated flaps. The pre-treated flaps were not significantly different than post-treated flaps in regard to flap survival.
Application of reduced pressure was tested upon chronic decubitus ulcers and was found to be effective in the treatment thereof. Necrotic soft tissue was removed from the ulcers prior to placement upon the treatment site of a reduced pressure appliance of the type described in connection with
Case 1—A 39 year-old male T4 paraplegic had suffered from multiple recurrent pressure sores over a period of 8 years. He had been treated for a trochanteric decubitus with a tensor fascia lata flap which had developed a recurrent ulcer in the center of the flap 4 months prior to presentation. The ulcer was debrided of necrotic tissue to non-involved periosteum resulting in a wound measuring 12 cm by 5 cm with a depth of 5 cm. During the course of 4 weeks of cyclic reduced pressure application, the wound progressively closed and spontaneously re-epithelialized. Reduced pressure of 5 in. Hg below atmospheric pressure was applied cyclically with 5 minute intervals of applied pressure followed by 5 minute intervals with no applied pressure. The wound remained healed more than 5 months after treatment.
Case 2—A 45 year old male paraplegic suffered from a recurrent right ischial fossa pressure sore and abscess prior to treatment. Debridement of the wound was carried out with partial ischial resection. A week later, a re-advancement of the V-Y biceps femoris flap and rotation gluteus flap was performed. Six days later, the wound dehisced and the patient developed bilateral pneumonia requiring ventilatory support. The flap became progressively edematous and firm and resisted all efforts at mobilization. At this point, reduced pressure treatment providing continuous, non-cyclic suction or a vacuum at approximately five 5 in. Hg below atmospheric pressure was initiated. A total of 2 liters of fluid was removed by the reduced pressure appliance during the first 72 hours of treatment. Intravenous fluids were administered to replace the fluid removed from the wound. The appliance was replaced and the wound was examined three times each week. Treatment was continued for a total of six weeks during which the flap became progressively less indurated, granulation tissue formation rapidly progressed, the edges of the wound came into approximation, and the wound was healed completely.
Case 3—A 51 year-old T1 paraplegic had multiple previous pressure sores culminating in bilateral asynchronous hip disarticulations and bilateral total thigh flaps. Seven months prior to admission, he developed a 7 cm by 23 cm pressure sore over the remnants of both ischia. Bone was exposed and no tissue was available for wound closure. Dressing changes over a period of three months had failed to improve the wound. A reduced pressure appliance was then secured to the wound. During the first 3 weeks of treatment, reduced pressure of 5 in. Hg below atmospheric pressure was continuously applied. For the following 9 weeks, reduced pressure was applied cyclically in 5 minute intervals. The appliance was replaced every three days during treatment. In the course of the treatment, the wound first granulated to cover the bone completely and then the wound re-epithelialized from the margins. After 12 weeks of the treatment, a 2 cm by 5 cm scrotal flap was used to cover the midline area of the wound. The wound has remained stable beyond 6 months after treatment.
A 50 year old debilitated white male who had undergone a colostomy through a midline laparotomy was re-admitted to the hospital for wound dehiscence and evisceration following an upper respiratory infection. He was taken immediately to the operating room and the abdominal wall was closed with Prolene mesh. Six weeks after placement of the Prolene mesh, the wound was still open and measured 28 cm by 23 cm. Only sparse granulation tissue had grown through the Prolene mesh during the six weeks. At this time a large reduced pressure appliance of the type shown in
Infected wounds have been successfully treated via application of reduced pressure as described in the following cases:
Case 1—A 39 year old white male sustained severe avulsive trauma to his left lower extremity in a motor vehicle accident 10 years prior to presentation. He presented with a ten year history of chronic osteomyelitis and a 3 cm diameter open ulcer with exposure of bone of his left lateral malleolus. He had previously undergone 7 local surgical procedures to attempt closure of the wound. An arteriogram demonstrated a one vessel foot with diffuse atherosclerosis and post traumatic changes. The extremity was debrided of necrotic soft tissue and all involved bone saucerized. The patient was placed on a five week course of antibiotics. The day after debridement, a reduced pressure device of the type shown in
Case 2—A 51 year old white male T8 paraplegic was admitted to the hospital for an infected left trochanteric pressure sore which had been present for one year and measured 4 cm by 6 cm. The patient had previously undergone multiple procedures for treatment of this condition including a V-Y advancement flap 4 months prior to presentation. A scan revealed possible chronic osteomyelitis of the left femur. It was decided to treat the potential osteomyelitis with a five week course of IV antibiotics. The wound was debrided, then treated using a reduced pressure appliance of the type shown in
A 45 year old black female patient with a 10 year history of bilateral stasis ulcers of the pretibial area was presented with bilateral 10 cm by 15 cm infected ulcers with exposed fascia. Two previous attempts at skin grafting in the previous year had failed. The patient was treated using a reduced pressure appliance of the type shown in
It is believed that the efficacy of reduced pressure appliances in such treatments as have been described is due at least in part to enhancement of blood circulation within the treated wounds. In order to determine the effect of pressure application upon blood flow, a laser doppler needle probe was inserted into tissue adjacent to a pressure sore. A baseline flow level was recorded for thirty minutes. Then, the relative blood flow level was measured while a reduced pressure corresponding to 5 in. Hg below atmospheric pressure was continuously applied to the wound for 30 minutes using a reduced pressure appliance of the type shown in
Then the supply of reduced pressure to the appliance was cycled on and off at equal 5 minute intervals. During the “off” portions of the cycle, the relative blood flow level was twice as high as the baseline level. It is postulated that the increased blood flow during the off cycle is likely due to a “rebound” phenomenon. During the “on” cycle, blood is drawn toward the wounded tissue from both the venous and arterial branches of the vascular network in the vicinity of the wound. During the “off” cycle, this blood is transported toward the venous branch of the vascular network at a rate that is greater than would have been observed in the absence of the preceding “on” cycle.
The terms and expressions which have been employed are used as terms of description and not of limitation and there is no intention in the use of such terms and expressions of excluding any equivalents of the features shown and described, or portions thereof, but it is recognized that various modifications are possible within the scope of the claimed invention.
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|Clasificación de EE.UU.||128/898|
|Clasificación internacional||A61M27/00, A61B17/00, A61M1/08, A61M16/06, A61B17/30, A61B17/08, A61F13/00, A61B19/00, A61F13/02, A61M1/00|
|Clasificación cooperativa||A61M27/00, A61M1/0088, A61M1/0023, A61M1/08, A61M2205/3379, A61M16/06, A61F13/02, A61F2013/00919, A61B2017/306, A61M1/008, A61M1/0056, A61M1/0037, A61B17/085, A61M1/005, A61B2017/00557, A61B19/00, A61B17/08|
|Clasificación europea||A61M1/00T6, A61F13/02, A61M27/00, A61B19/00|