Surgery – Means for introducing or removing material from body for... – Treating material introduced into or removed from body...
Reexamination Certificate
2000-06-30
2003-04-22
Walberg, Teresa (Department: 3742)
Surgery
Means for introducing or removing material from body for...
Treating material introduced into or removed from body...
C601S152000
Reexamination Certificate
active
06551280
ABSTRACT:
FIELD OF THE INVENTION
The present invention relates to therapeutic devices and medical appliances that provide support or pressure to tissue. In particular, the invention relates to devices and appliances comprising open cell foam usefull in the treatment of diseases, disorders and injuries.
BACKGROUND OF THE INVENTION
Patients suffering from injury or disease or recovering from surgery may be treated by the application of constant or intermittent pressure. Pressure is used to control swelling, increase blood flow, and immobilize tissue.
In cases of acute injuries, such as acute joint injury, three treatments are employed simultaneously. First, the injured region is chilled (such as with ice); second, pressure is applied using an elastic bandage; and third, immobilization is achieved using a splint. For example, an athletic trainer applies elastic wrap to an injured ankle or knee and then immobilizes the joint with a splint or bulky bandage. However, the application of elastic wrap may produce a wide range of pressures on the injured limb. The incorrect pressure may retard venous or arterial circulation and may contribute to thromboembolism; pressure that is too high can induce tissue ischemia that further injures the tissue.
More complex pressure devices are available to patients suffering from various venous, circulatory and peripheral vascular diseases. These devices typically consist of an inflatable bladder in the form of a sleeve that can be placed around all or a portion of a patient's arm or leg. The bladder is connected to a pump that alternately inflates and deflates the bladder. In some such devices, the sleeve placed around the extremity includes a number of sequential bladders along the axial length of the sleeve to allow the sleeve to be inflated and deflated in a peristaltic manner along its length. By alternately inflating and deflating the bladder or bladders contained within the sleeve, circumferential pressure is applied to the patient's extremity, thus aiding in the circulation of blood there through. Such systems are currently used to treat venous insufficiency, prevent deep venous thrombus and control lymphedema and improve tissue perfusion in patients with peripheral arterial disease.
Other medical devices such as catheters and tracheotomy tubes are placed into a body lumen and then held in place with an inflatable balloon at the distal end of the device. The balloon is subject to over-inflation, however, again resulting in possible damage to treated tissue.
In addition, current systems tend to be expensive and complex, frequently being coupled to feedback circuits to control changes in pressure. Compression systems have been known to malfunction and cause undesirable variability in or increase in the applied pressure. Even when such systems are controlled by the patient, they may be subject to incorrect operation resulting in over-inflation of the sleeve. For such a system used to correct venous insufficiency in a limb, for example, incorrect operation is at best painful and at worst results in loss of the limb. Finally, most patients complain of some level of pain during inflation due to the rapid increase in pressure against the extremity.
In view of the above, the need exists for therapeutic devices that are capable of applying pressure but which are unable to produce over-pressure at the site of damage or disease. Such devices should be simple to use, allow peristaltic pumping at a variety of pressures, and have the ability to apply heat or cold.
SUMMARY OF THE INVENTION
The present invention relates to therapeutic devices that provide support or pressure to tissue. In particular, the invention relates to such devices comprising open cell foam useful in the treatment of diseases and injuries. The open cell foam is in a relaxed or relaxed state until application of vacuum resulting in an evacuated state. The foam is engineered to produce a device that has characteristics that provide a maximum desirable pressure and that will avoid the possibility of over-pressure which can result in tissue damage or necrosis.
In a first aspect, this invention is a medical device for applying pressure to tissue comprising a body portion having a relaxed state and a contracted state, the body portion being configured to apply pressure to tissue in the relaxed state, the body portion adapted to contain a fluid; and a fluid controller fluidly connected to the body portion for removing fluid contained in the body portion, the body portion being configured to contract from the relaxed state to the contracted state upon removal of fluid from the body portion. The body portion may comprise foam and preferably comprises open cell foam. The body portion also may include a fluid impermeable outer coating. The medical device may also comprise a fluid source and a valve, the valve being connected between the body portion and the fluid source and fluid controller, the valve having a first position for connecting the body portion to the fluid controller and a second position for connecting the body portion to the fluid source. The fluid controller may be a vacuum source. The valve preferably is programmable and the valve may be programmed to switch between the first position and the second position. The medical device may comprise a bladder fluidly connected to a liquid wherein the liquid is hot or cold.
In a second aspect, this invention is a medical device for applying pressure to a human or animal limb comprising a body portion having a substantially cylindrical shape sized to fit over the limb, the body portion being adapted to contain a fluid and further having a relaxed state and a contracted state, the body portion being configured to apply pressure to the limb in the relaxed state, and a fluid controller fluidly connected to the body portion for removing fluid contained in the body portion, the body portion being configured to contract from the relaxed state to the contracted state upon removal of fluid from the body portion. The body portion may comprise open cell foam and may include a fluid impermeable outer coating.
In a third aspect, this invention is a medical device for applying pressure to tissue comprising a body portion having at least two separate compartments, each compartment having a relaxed state and a contracted state and being configured to apply pressure to tissue in the relaxed state, the compartments being adapted to contain a fluid, and a fluid controller fluidly connected to each compartment of the body portion for removing fluid contained in the body portion, each compartment being configured to contract from a relaxed state to a contracted state upon removal of fluid from the compartment. The device may include valves, the valves being connected between each compartment and the fluid source and fluid controller and having a first position for connecting the compartment to the fluid controller and a second position for connecting the compartment to the fluid source. Each compartment may be separately cycled between the first and second position of the at least one valve in a sequence so as to apply pressure to tissue in a peristaltic manner.
In a fourth aspect, this invention is a medical device for applying pressure to tissue comprising a body portion having a first region configured to apply a first pressure to tissue and a second region configured to apply a second pressure to tissue, each region having a relaxed state and a contracted state and capable of applying pressure to tissue in the relaxed state, the regions being adapted to contain a fluid, a fluid controller fluidly connected to the body portion for removing fluid contained in the body portion, each region being configured to contract from a relaxed state to a contracted state upon removal of fluid from the compartment, wherein the first pressure is not equal to the second pressure. The pressure of the first and second regions may form a gradient.
In a fifth aspect, this invention is a method of applying pressure to tissue comprising supplying, adjacent to the tissue, a devi
Fiegel Vance D.
Knighton David R.
Embro Corporation
Fastovsky Leonid
Popovich & Wiles, P.A.
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