Therapeutic device and system

#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 useful in the treatment of diseases, disorders and injuries.

#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.

#FIGS. 1A to 1E illustrate the expansion and evacuation cycles of devices of the present invention.

#FIG. 2 is a thickness versus pressure graph of the open cell foam used in a preferred embodiment of this invention.

#FIG. 3 is an illustration of a multi-pressure device on a patient's leg.

#The devices of this invention comprise a body portion made of a material that is capable of being contracted from its relaxed or resting state to an evacuated or contracted state. “Relaxed state” refers to the condition of the material when no external forces are acting on it to cause the material to expand or contract. The evacuated or contracted state of the material is produced by removal of fluid contained within the material. The terms “evacuated” and “contracted” refer to the application of vacuum on the material resulting in a reduction of pressure within the material as compared to ambient pressure. Vacuum can be applied by means of various pumps, aspirators, and suction devices.

#Any material that is capable of being contracted from a relaxed state to an evacuated state may be used in the devices of this invention. Preferably, the material is an engineered open cell foam. A piece of the open cell foam in a relaxed state is larger than the same piece in an evacuated state. In its relaxed state, the open cell foam is at ambient pressure; that is, the pressure inside the foam is that same as that outside the foam. The open cell foam is in a relaxed state until application of vacuum (for example, due to suction from a water aspirator or from a syringe), resulting in an evacuated state. The foam is designed to apply a desired pressure to the tissue of a patient in its relaxed state. One such suitable foam is commercially available from New Dimension Industries, Inc., of Moonachie, N.J., under the designation “2000 YELLOW”.

#FIG. 1A illustrates the relaxed state of a material used for the medical devices of this invention. Foam 10 is covered with generally impermeable jacket or covering 12. This enables the body portion to assume and maintain a contracted, evacuated state when air is evacuated from the foam. Vacuum line 14 permits communication of air and vacuum with the foam. Vacuum line 14 is fitted with valve 16 which connects the foam to either vacuum source 15 or air/fluid source 17. Air/fluid source 17 may simply be open line 14 to the atmosphere or may be a line to a source of fluid, such as water. This may be a manual valve, such as a gate valve, controllable by a patient or physician, or it may be a solenoid valve that can be programmed to cycle the foam between the relaxed and evacuated states. FIG. 1B shows the valve open to vacuum resulting in evacuated state 10. FIG. 1C shows foam 10 positioned near tissue T that is to undergo treatment. FIG. 1D shows relaxed state foam 10 creating a pressure against the tissue. FIG. 1E shows the next step in the cycle, i.e., evacuation state of foam 10.