JP2007522892A - Compression device - Google Patents

Abstract

  The compression device includes an expandable body configured to be positionable around the foot. The strap extends from the body. The strap is configured to be placed around the foot near the ankle. The strap has a first layer configured to engage the outer surface of the foot near the ankle, a second layer, and a third cushion layer disposed between the layers. The body may include a metatarsal portion. The first layer and the second layer can be configured to provide a protective layer for the third cushion layer. The first layer can be configured to prevent the third cushion layer from engaging the outer surface of the foot.

Description

Detailed Description of the Invention

Background 1. TECHNICAL FIELD The present disclosure relates generally to the field of vascular therapy for application to the limbs of the body and, more particularly, to a compression device configured to artificially stimulate limb blood vessels.

2. 2. Description of Related Art Conditions that form blood clots such as deep vein thrombosis (DVT) and peripheral edema are serious problems for immobile patients and similar people. Such patients and people include patients undergoing surgery, patients with numbness, long-term bed care patients and others. These clot symptoms typically occur in the deep veins of the lower limbs and / or pelvis. These veins such as the iliac, femoral, popliteal and tibia circulate oxygen-depleted blood to the heart. When these venous blood circulations are suppressed due to disease, injury or inactivity, blood tends to accumulate or become congested. Static congestion is good for dangerous clot formation. The major risk associated with this condition is cardiovascular circulatory disturbance. The most serious is that the clot fragments peel off and move. Pulmonary embolism forms a main pulmonary artery occlusion and is life threatening.

  Symptoms associated with the patient's immobility and the resulting risks can be suppressed or alleviated by applying intermittent pressure to the patient's limbs, such as the legs and portions of the feet, to assist in blood circulation. Well known devices such as one-piece pads and compression boots have been used to assist in blood circulation. See, for example, U.S. Pat. Nos. 4,696,289 and 5,989,204.

  Compression devices consisting of an air pump connected to a disposable wrap pad with one or more air tubes have been used. This wrapping pad is placed around the patient's leg or around the other limb. Air is then forced into the wrapping pad that creates pressure around the foot or other limb part.

  These known devices have various drawbacks due to their bulky and cumbersome use and limb contamination and inflammation during application and use. These disadvantages are disadvantageous in that they reduce comfort, adaptability, cause skin damage and hinder patient mobility during postoperative recovery.

  Accordingly, it is desirable to overcome the disadvantages and shortcomings of the prior art with a foot sleeve that prevents contamination, reduces skin damage accidents, and is easy to place on the limb. The intent is that the compression device including the foot sleeve is not bulky, is not cumbersome to use, and improves patient comfort and conformability. Furthermore, the compression device is intended to be easily and efficiently manufactured.

SUMMARY Accordingly, to overcome the disadvantages and drawbacks of the prior art, a compression device is provided that prevents contamination, reduces skin damage accidents, and is easy to place on the limb. Desirably, the compression device including the foot sleeve is not bulky and is not cumbersome to use so as to improve patient comfort and conformability. The compression device can be manufactured easily and efficiently.

  Embodiments of compression devices according to the present disclosure provide for the prevention of deep vein thrombosis (DVT), for example, by artificially stimulating blood vessels in the entire foot including the patient's toes and heels to increase the patient's blood circulation. Configured to provide a vascular treatment comprising: The compression device according to the present disclosure is an intermittent pneumatic compression device for applying slow compression to the foot. This pressure simulates blood flow that normally occurs during walking, for example, by utilizing a foot sleeve supported around the patient's foot.

  The compression device has an inflatable bladder designed to cover and engage the entire area of the bottom of the foot beyond the heel and thumb ball to a significant portion of the toe. The inflatable bladder wraps around the side of the foot through a hook-and-loop fastener (magic tape) flap that crosses the instep.

  The inflatable bladder may include an outer layer and an inner layer. The bladder can be formed by welding the outer and inner layers together. The bladder provides a uniform pressure application across the foot and then contracts. Further, the compression device can include a bladder section that can detect venous refill. The compression device according to the present disclosure includes various modifications and combinations as can be understood herein. Each of the various modifications and combinations can be manufactured in a variety of sizes to fit the object of varying size as well as the left and right foot models.

  The compression device includes a strap that improves comfort by using a single layered structure where the inner layer is a cushion layer. The strap is sandwiched between separate layers of the foot sleeve body and integrated with the foot sleeve. Patient comfort is improved by segmenting the strap to follow the heel of the foot. The strap can also include one or more layers configured to provide protection of the cushion layer from the surrounding environment. The leg sleeve has a universal design with a metatarsal lock on a single flap, thereby improving ease of use.

  The strap can include a stack of various layers. The layer can include a central layer configured for comfort. An outer layer located around the center layer provides a protective layer between the surrounding environment and the outer surface of the foot. One of the outer layers can be a soft skin contact layer when touched. The strap may be sandwiched between separate layers of the foot sleeve body, integrated with the foot sleeve body, and permanently fixed. The foot sleeve body may be designed to fit a variety of foot sizes and shapes by utilizing a single metatarsal flap that facilitates use. The body may be configured to allow inspection of the upper part of the phalange of the foot.

  One advantage of the present disclosure is a cushion layer that does not directly engage the outer surface of the foot. The cushion layer has a soft skin contact layer. The foot sleeve can also include a lining configured to help prevent contamination and provide a physical protective layer to the cushion layer. The inner cushion layer provides comfort and reduced skin damage. Thus, this foot sleeve improves patient conformity and maintains hygiene by separating the cushion layer from the surrounding environment.

  The foot sleeve is easy to manufacture. For example, the stack material contained within the layer allows the strap and / or foot sleeve to be cut as one piece, ensuring a uniform stack of material.

  In one embodiment in accordance with the principles of the present disclosure, a compression device includes an expandable body configured to be placed around a foot. The strap extends from the body. The strap is configured to be placed around the foot near the ankle. The strap has a first layer configured to engage the outer surface of the foot near the ankle, a second layer, and a third cushion layer disposed between the layers.

  The strap can be connected integrally with the expandable body. Alternatively, the strap may be integrally formed with the expandable body. The expandable body can include a first upper layer and / or a second lower layer. Further, a part of the strap member may be disposed between the upper layer and the lower layer of the foot sleeve body. The strap may have a segment configuration that matches the outer shape of the foot. The third cushion layer can be disposed in the first layer and the second layer such that the first layer and the second layer are protective layers for the third cushion layer. The body can include a metatarsal strap.

  Alternatively, the first layer comprises a soft polyester material. The first layer may include a soft polyester material and vinyl chloride. The third cushion layer may include a foam material. The second layer can have an outer surface that includes a loop material disposed thereon. The second layer may include a vinyl chloride material and the outer surface has a loop material disposed thereon. Alternatively, to attach the compression device to the foot, the second layer has an outer surface that includes a loop material and the metatarsal strap includes a hook element that is engageable with the loop material. The body can include a hook element engageable with the loop material for attaching the compression device to the foot.

  In an alternative embodiment, the compression device has a foot sleeve that includes an inflatable body configured to be positionable around the foot. The foot sleeve includes a metatarsal portion. The strap is integrally connected to and extends from the foot sleeve. The strap is configured to be placed around the foot near the ankle. The strap has a first layer configured to engage the outer surface of the foot near the ankle, a second layer, and a third cushion layer disposed between the layers. The first layer and the second layer are configured to provide a protective layer for the third cushion layer. The first layer may be configured to prevent the third cushion layer from engaging the outer surface of the foot.

DETAILED DESCRIPTION OF EXEMPLARY EMBODIMENTS Illustrative embodiments of a compression device and method of operation including a disclosed leg sleeve will be described in terms of vascular treatment including a compression device for application to a body foot or other limb This will be described in more detail in terms of a compression device configured to artificially stimulate limb blood vessels including the patient's feet, heels, and toes. The compression device is intended to be used to prevent and overcome risks associated with patient immobility. Furthermore, it is also intended that the compression device relieves the medical condition resulting from the patient's immobility and prevents, for example, DVT, peripheral edema. The compression device according to the present disclosure is intended to be used in a variety of venous compression systems including, but not limited to, rapid inflation, slow compression, non-sequential, and sequential compression devices. However, the present disclosure provides for a wide range of immobilization of people and similar patients such as, for example, patients undergoing surgery, patients with numbness, long-term bed therapy, obese patients, elderly patients, malignant tumor patients, patients with early thromboembolism, etc. I am considering applying the condition to a medical condition.

  In the following detailed description, the term “subject” refers to a patient who receives vascular treatment using a compression device. The following detailed description includes a description of the compression device, followed by a description of an exemplary method of operating the compression device according to the principles of the present disclosure. Reference will now be made in detail to the exemplary embodiments and disclosure, which are illustrated in the accompanying figures.

  In the figures, like elements are designated by like numerals throughout the several views. Reference is first made to FIGS. 1, 1A, and 2 showing a compression device 10 constructed in accordance with the principles of the present disclosure (eg, filed on Feb. 23, 2004, which is incorporated herein by reference in its entirety). (See compression sleeve described in US patent application Ser. No. 10 / 784,607, entitled “Compression Device”). The compression device 10 includes, for example, an expandable main body such as a foot sleeve 12 configured to be disposed around a foot F of a subject (not shown). The foot sleeve 12 can be placed on the subject's right foot or left foot. The foot sleeve 12 is in fluid communication with a source of pressurized fluid via a tube 16 and a valve connector 18 to apply pressure to the left foot and / or right foot to provide vascular treatment to the subject and increase venous perfusion ( For example, the valve connector described in US patent application Ser. No. 10 / 784,639, filed Feb. 23, 2004, entitled “Fluid Conduit Connector Device”, filed February 23, 2004, which is incorporated herein by reference in its entirety. reference). The compression device 10 utilizes a controller 20 that adjusts fluid pressure for vascular treatment. See, for example, the controller described in US patent application Ser. No. 10 / 784,323, filed Feb. 23, 2004, entitled “Pressure Treatment System,” which is incorporated herein by reference in its entirety. The pressurized fluid source 14 includes a pump and may be fixed or portable. The pressurized fluid source 14 is intended to include the necessary electronic circuitry and computer software to perform blood treatment according to the principles of the present disclosure.

  The foot sleeve 12 is configured to provide vascular treatment to the entire bottom area of the foot F beyond the heel H and thumb ball B to a substantial portion of the toe T. It is contemplated that the foot sleeve 12 and other parts of the compression device 10 can be placed, wrapped and attached to various limbs, limbs, etc. of the subject's body, such as the legs and arms, for example. Further, the sleeve 12 or portions thereof are intended to be disposable. Assuming sleeve 12 may include a flexible area, such as an elastic or spandex material that facilitates movement of the limb during use. The construction of the strap 22 can be made from materials suitable for compression vascular treatment, such as membranes, fabrics, such as PVC (polyvinyl chloride) and PE (polyethylene).

  The strap 22 is configured to be arranged around the foot F near the ankle. As will be described later, the strap 22 is integrally connected to the foot sleeve 12 and attached and fixed between the foot contact layer 26 and the outer layer 28 of the foot sleeve 12. The strap 22 may be formed integrally with the foot sleeve 12, in which case at least a portion of the strap 22 is formed of the same continuous material as a portion of the foot sleeve 12. While not limiting, the foot contact layer 26 can be formed from the same continuous material as the foot contact layer 32 of the foot sleeve 12. The strap 22 has a segment portion 24 configured to follow the heel H of the foot F. The segment portion 24 can vary in configuration and dimensions, such as rounded, and alternatively, the outer surface of the strap 22 can be uniform, such as smooth.

  The strap 22 has a first layer, such as a foot contact layer 26 configured to engage the outer surface of the foot F near the ankle, for example. The foot contact layer 26 includes a soft polyester material 26a for engaging the subject's skin. This soft skin contact layer 26 has the advantages of providing comfort to the subject, preventing contamination and reducing skin damage. The foot contact layer 26 may include a PVC portion 26b disposed adjacent to the soft polyester material 26a.

  For example, a second layer, such as outer layer 28, cooperates with foot contact layer 26 such that third layer 30 is disposed therebetween. The third layer 30 includes a foam material for providing a cushion effect to the subject. It is contemplated that layer 30 may include alternative materials that provide a cushion configuration. Outer layer 28 includes a loop material 28a disposed therein for engaging a corresponding hook element of foot sleeve 12 and a PVC portion 28b disposed adjacent to loop material 28a. The outer layer 28 has an advantage of preventing contamination of the third cushion layer 30 from the surrounding environment such as air, moisture, and dust.

  The foot contact layer 26 and the outer layer 28 are configured to form a physical protective layer to the third cushion layer 30. This configuration has advantages such as adaptability, providing comfort to the subject, and preventing contamination of the third cushion layer 30. In an alternative embodiment shown in FIG. 3, the strap 22 includes a laminated structure having a cushion layer 130 and a PVC portion 132 disposed adjacent thereto. The outer layer 134 is disposed adjacent to the PVC portion 132. Layer 134 may include a soft polyester material for engaging the outer surface of foot F, or alternatively may include a loop material that prevents contamination of cushion layer 130 by the surrounding environment.

  The foot contact layer 26 and the outer layer 28 are laminated to form the strap 22. The foot contact layer 26 and the outer layer 28 are joined and fixed at seams adjacent their corresponding perimeters to support the structure of the strap 22. The structure of the strap 22 may be fixed through welding, for example, RF welding, an adhesive, an industrial strength double-sided adhesive tape, or the like. Assuming only a portion of the foot contact layer 26 and the outer layer 28 are joined. As a further assumption, the strap 22 includes a plurality of seams around the periphery for joining the foot contact layer 26 and the outer layer 28 in various arrangements.

  In an alternative embodiment, reference is made to FIG. 1A, which shows an exaggerated partial enlarged cross-sectional view showing the coupling to the strap member 22 and foot sleeve 12. The strap member 22 is disposed between the foot contact layer 32 and the outer layer 42 of the foot sleeve 12 so that the connection between the strap 22 and the foot sleeve 12 is substantially uniform. This uniformity provides additional comfort to the user of the foot sleeve 12. More particularly, the foot contact layer 26 and the outer layer 28 of the strap 22 are joined to the inner portions of the foot contact layer 32 and the outer layer 42 of the foot sleeve 12. Alternatively, as intended, the cushion layer 30 may or may not be disposed between the foot contact layer 32 and the outer layer 42 of the foot sleeve 12.

  The strap 22 has a long projecting configuration extending from the foot sleeve 12 and is configured to be disposed around a portion of the foot F close to the ankle. The strap 22 forms part of a hook and loop type fastener. The hook element 33 is attached to the foot contact layer 26 of the strap 22. When the strap 22 is wrapped around the portion of the foot F near the ankle, the hook element 33 engages the loop material of the outer layer 42 of the foot sleeve 12 so that the foot sleeve 12 can be easily attached to the foot F. As an alternative to hook and loop type elements, clips, adhesives, and pins may be utilized.

  The foot sleeve 12 includes a foot contact layer 32 configured to engage the foot F to apply pressure. The foot contact layer 32 has a section 35 and is flexible to conform to the shape of the foot F. It is envisioned that the foot contact layer 32 can be made from a polyester fabric. As intended, the foot contact layer 32 may be configured to allow fluids such as moisture and sweat from the outer surface of the foot F to escape. The foot contact layer 32 may be chemically treated to enhance the effect of escaping such moisture. Alternatively, the foot contact layer 32 may be integrally formed with the foot contact layer 26 of the strap 22.

  The inflation bladder 34 of the foot sleeve 12 includes an upper bladder layer 36 and a lower bladder layer 38 that are laminated to form the inflation bladder 34. The upper bladder layer 36 engages with the foot contact layer 32 to easily apply pressure to the foot F for vascular treatment. The upper bladder layer 36 and the lower bladder layer 38 are joined and secured by welding at seams along their perimeter to define the expanded bladder 34. It is contemplated that the inflation bladder 34 may include a plurality of seam portions in various arrangements that join the upper bladder layer 36 and the lower bladder layer 38 together. Further, as intended, the seam can be formed by an adhesive, heat seal, or the like.

  The upper bladder layer 36 and the lower bladder layer 38 can be made of a laminated material, for example, a PVC material. As intended, the thickness of each bladder layer is approximately 6-15 mils. Further, as intended, PVC materials can be laminated to non-woven or woven materials and can be RF heat sealed. The upper bladder layer 36 and the lower bladder layer 38 may be made in two different thicknesses to provide directional expansion. The overall dimensions and materials described throughout this disclosure are not limited and other dimensions and materials may be used. Further, the expansion bladder 34 may define one or more expansion chambers.

  The inflatable bladder 34 extends along the foot F and provides vascular treatment to the entire area of the bottom of the foot F, over the heel H and the ball B, to a substantial portion of the toe T. As intended, the inflatable bladder 34 can be a variety of geometric shapes, such as circular, elliptical, and rectangular. The inflation bladder 34 includes an inlet port 40 that connects to the tube 16 and is in easy fluid communication with the pressurized fluid source 14.

  The outer layer 42 of the foot sleeve 12 is disposed near the lower bladder layer 38. The outer layer 42 can be made from a woven material and a loop material, for example a laminate comprising a loop / nonwoven laminate. The outer layer 42 provides a mounting surface for the hook elements. Alternatively, the outer layer 42 may be integrally formed with the outer layer 28 of the strap 22.

  Outer layer 42 may include a hole drilled in the mold to provide a through fluid inlet, such as inlet port 40. The outer layer 42 and other portions of the foot sleeve 12 include exhaust openings that are variously arranged around it so as to provide a cooling effect to the subject and increase mobility during use. Also good.

  The foot contact layer 32 and the outer layer 42 are laminated to form the foot sleeve 12. The foot contact layer 32 and the outer layer 42 are joined and fixed at seams adjacent to the corresponding periphery to support the component of the foot sleeve 12. The structure of the foot sleeve 12 may be fixed through welding, for example, RF welding, adhesive, industrial strength double-sided adhesive tape, and the like. It is also contemplated that only a portion of the periphery of the foot contact layer 32 and the outer layer 42 is joined. The foot sleeve 12 is also intended to include a plurality of variously arranged seam portions that join the foot contact layer 32 and the outer layer 42 around the foot sleeve 12.

  The construction of the foot sleeve 12 is a compressed blood vessel, such as a membrane, fabric, etc., such as PVC (polyvinyl chloride) or PE (polyethylene), depending on the particular vascular treatment application and / or preference. Can be made from materials suitable for treatment. Semi-flexible and flexible fabrics such as urethane and silicon may be used. Further, the foot sleeve 12 can be made from synthetic, natural, and non-woven materials that vary in the degree of softness and flexibility. However, it will be appreciated by those skilled in the art that other materials and fabrication methods suitable for assembly and manufacturing may be used in accordance with the present disclosure.

  The foot sleeve 12 is configured to support the inflation bladder 34. The foot sleeve 12 extends in the lateral direction, and can be arranged around the foot F and can be attached to the foot F. The foot sleeve 12 is placed on the foot F so that the top of the toe T is visible for observation and examination. The metatarsal flap 44 of the foot sleeve 12 wraps around the side portion of the foot F and crosses the instep of the foot F during vascular treatment. Metatarsal flap 44 forms part of a hook and loop fastener. The hook element 46 is attached to the foot contact layer 32 of the foot sleeve 12. When the metatarsal flap 44 is wrapped around the foot F, the hook element 46 engages with the loop material of the outer layer 42 so that the foot sleeve 12 is easily attached to the foot F. That is, in this way, the expansion bladder 34 is disposed around the foot F for vascular treatment. This configuration of the foot sleeve 12 has the advantage of engaging the foot F to increase the circulation of the limb blood vessels. It is contemplated that the foot sleeve 12 may be various geometric shapes, such as circular, oval, and rectangular. As an alternative to hook and loop type elements, clips, adhesives, and pins may be utilized.

  A compression device 10 similar to that described above is assembled and packaged for use. In use, as described above, the foot sleeve 12 of the compression device 10 is disposed around the foot F and is in fluid communication with the pressurized fluid source 14. The controller 20 adjusts the vascular treatment of the compression device 10 to the subject. The foot sleeve 12 applies pressure to the foot F to give the subject vascular treatment and increase venous perfusion. The compression device 10 can include, for example, an inflatable sleeve that can be placed around various parts of the subject's limbs, such as the thigh, calf, and ankle, and another limb to another sleeve. Can be treated with alternating compression cycles.

  For example, during the compression cycle selected for the controller 20, the inflation bladder 34 is slowly inflated with air over a period of 5 seconds to a pressure on the order of 130 mmHg. This configuration provides vascular therapy to the foot F and increases venous perfusion. When the inflation and holding is complete, the foot sleeve 12 is evacuated and the inflation bladder 34 contracts. Other compression cycles and pressures are also contemplated.

  In an alternative embodiment, the compression device 10 performs a venous refill time measurement. Venous refill time (VRT) measurement is an air plethysmographic technique that determines the time during which a limb vein is completely refilled with blood under a compression cycle. See, for example, venous refill time measurement as described in Watson et al., US Pat. No. 6,231,352, which is incorporated herein by reference in its entirety. VRT minimizes the time that blood is stagnant in a vein. Replace the default pause time between compression cycles with VRT. As intended, VRT techniques and algorithms can be used to compress leg and foot sleeves.

  The VRT measurement uses an air plethysmographic technique that applies a low pressure to the expansion bladder 34. As the vein fills with blood, the pressure in the inflation bladder 34 increases until it reaches a steady state. The time taken to reach steady state pressure is VRT. When connecting two sleeves to the controller 20, the VRT is determined separately for each limb being compressed and the larger of the two measurements is used as the new exhaust time for the compression cycle. The VRT measurement for each sleeve is made independently when each particular sleeve reaches a set pressure. However, the exhaust time is not updated until VRT measurements are calculated for both sleeves.

  For example, the compression device 10 can perform VRT measurements after the system begins vascular treatment. After 30 minutes, VRT measurements are taken during the entire period of the next expansion cycle. After the foot sleeve 12 is inflated, the inflation bladder 34 is evacuated to zero.

  As intended, the selected bladder pressure is monitored and when the pressure drops to 5-7 mmHg, the exhaust opening leading to the bladder is closed. When the bladder pressure reaches 5-7 mmHg in the current cycle, VRT measurement is performed. If the bladder pressure does not drop to 5-7 mmHg after evacuation, leave the evacuation time at the current value and make another measurement within 30 minutes.

  The VRT measurement algorithm determines the time after which the pressure of the inflation bladder 34 is in a steady state after compression. The VRT measurement algorithm starts when the inflation bladder 34 reaches 5-7 mmHg (pressure sufficient to keep the bladder in contact with the foot surface) and the inflation cycle is completed after the exhaust stops. It starts with the time counter. The VRT measurement begins with a time counter starting from the end of the expansion cycle.

  The pressure in the inflation bladder 34 is then monitored with a 10 second moving sample window. The window moves at 1 second intervals. If the difference between the first and last value in the window is less than about 0.05-0.5 mmHg, the curve has reached a steady state. The VRT measurement is considered complete and the time interval is determined. The end of the window is considered to be when the foot venous system is refilled.

  If at any time during the measurement, the pressure in the expansion bladder 34 falls below 2 mmHg, the VRT measurement is considered an error and the calculation is discarded and the old value of VRT is used. This happens when there is a leak in the system. It is also contemplated that if the pressure exceeds 20 mmHg at any time during the VRT measurement, the old value of VRT is used.

  Reference is made to FIG. 4 showing an alternative embodiment of the compression device 10. The compression device 10 includes a foot sleeve 212 configured to be disposed about a foot F, similar to the foot sleeve 12 described above with respect to FIGS. Extending from the foot sleeve 212 is a pair of straps 222 similar to the straps 22 described above with respect to FIGS. The strap 222 is configured to be arranged around the foot F near the ankle. One or more straps 222 can be utilized.

  The strap 222 has a long projecting configuration extending from the foot sleeve 212 and can be arranged around a portion of the foot F near the ankle. As described herein, it is contemplated that the strap 222 can be formed separately or integral with the foot sleeve 212. The strap 222 forms part of a hook and loop type fastener. A hook element 232 and a loop element 232 a are attached to the strap 222. As each of the straps 222 is wrapped around a portion of the foot F near the ankle, the hook element 232 engages the loop element 232a and the foot sleeve 212 is easily attached to the foot F. It is also contemplated that the hook elements 232, 232 a can engage a loop material disposed on the outer surface of the foot sleeve 212 to easily attach the foot sleeve 212 to the foot F.

  An inflatable bladder 234 similar to the bladder 34 described above with respect to FIGS. 1 and 2 extends long along the foot F and extends beyond the heel H and thumb ball B to a substantial portion of the toe T to the full area of the bottom of the foot F. Give vascular treatment. The inflation bladder 234 includes an inlet port 240 connected to the tube 16 to facilitate fluid communication with the pressurized fluid source 14.

  The foot sleeve 212 is configured to support the inflation bladder 234. The foot sleeve 212 extends in the lateral direction, is configured to be disposed around the foot F, and is attached to the foot. The foot sleeve 212 is placed on the foot F so that the top of the toe T is visible for observation and inspection. A pair of metatarsal flaps 244 wrap around the side of the foot F during vascular treatment and extend laterally from the foot sleeve 212 to cross the instep of the foot F. Metatarsal flap 244 forms a hook and loop fastener. The hook element 246 and the loop element 246a are attached to the foot sleeve 212. When wrapping around the foot F with the metatarsal flap 244, the hook element 246 engages with the loop element 246a to engage the foot sleeve 212, and the foot sleeve 212 is easily attached to the foot F. Thus, the expansion bladder 234 is disposed around the foot F for vascular treatment. This configuration of the foot sleeve 212 has the advantage of engaging the foot F and increasing the circulation of the limb blood vessels. The foot sleeve 212 includes an exhaust opening 250 arranged to provide a cooling effect to the subject and increase mobility during use.

  Reference is made to FIG. 5 showing another alternative embodiment of the compression device 10. The compression device 10 includes a foot sleeve 312 similar to the above-described foot sleeve configured to be disposed around the foot F. Extending from the foot sleeve 312 is a strap 322 similar to the strap described above. An inflatable bladder 334, similar to the inflated bladder described above, extends long along the foot F and provides vascular treatment to the entire area of the bottom of the foot F beyond the heel H and the ball B to a substantial portion of the toe T. . The inflation bladder 334 includes a side portion 336 that extends laterally therefrom to engage the side portion of the foot F during application of the foot sleeve 312 to the foot F.

  The foot sleeve 312 is configured to support the inflation bladder 334. The foot sleeve 312 extends in the lateral direction, is configured to be disposed around the foot F, and is attached to the foot. The foot sleeve 312 is placed on the foot F so that the top of the toe T is visible for observation and inspection. A pair of metatarsal flaps 344 extend laterally from one side of the foot sleeve 312 so as to wrap around the side of the foot F and cross the instep of the foot F during vascular treatment. Metatarsal flap 344 forms part of a hook and loop fastener. The hook elements 346, 346 a are attached to the foot sleeve 312. When wrapping around the foot F with the metatarsal flap 344, the hook elements 346, 346a engage with the loop material of the foot sleeve 312 so that the foot sleeve 312 is easily attached to the foot F. An inflatable bladder 334 including a side portion 336 that engages a side portion of the foot F for vascular treatment is now disposed around the foot F. This configuration of the foot sleeve 312 has the advantage of engaging the foot F and increasing the circulation of the limb blood vessels.

  Reference is made to FIG. 6 showing another alternative embodiment of the compression device 10. The compression device 10 includes a foot sleeve 412 similar to the above-described foot sleeve configured to be disposed around the foot F. Extending from the foot sleeve 412 is a strap 422 similar to the strap described above. An inflatable bladder 434, similar to that described above, extends long along the foot F and provides vascular treatment to the bottom of the foot F beyond the heel H and the ball B to a substantial portion of the toe T.

  The foot sleeve 412 has wings 444 (similar to the metatarsal flap described above) and is configured to support the inflation bladder 434. The foot sleeve 412 extends in the lateral direction via the wing portion 444, is configured to be disposed around the foot F, and is attached to the foot. The foot sleeve 412 is placed on the foot F so that the top of the toe T is visible for observation and inspection. The wing portion 444 wraps around the side portion of the foot F and crosses the instep of the foot F during vascular treatment. The wing 444 forms part of a hook and loop fastener. Hook element 446 and loop element 446 a are attached to wing 444. When the wing portion 444 wraps around the foot F, the hook element 446 engages with the loop element 446a, and the foot sleeve 412 is easily attached to the foot F. Thus, the expansion bladder 434 is disposed around the foot F for vascular treatment. This configuration of the foot sleeve 412 has the advantage of engaging the foot F and increasing the circulation of the limb blood vessels.

  Reference is made to FIG. 7 showing another alternative embodiment of the compression device 10. The compression device 10 includes a foot sleeve 512 similar to the above-described foot sleeve configured to be disposed around the foot F. Extending from the foot sleeve 512 is a strap 522 similar to the strap described above. An inflatable bladder 534, similar to the inflated bladder described above, extends long along the foot F and provides vascular treatment to the bottom of the foot F beyond the heel H and the ball B to a substantial portion of the toe T. The inflation bladder 534 includes a longitudinal portion 536 extending longitudinally therefrom to engage a desired portion of the bottom of the foot F while the foot sleeve 512 is applied to the foot F. The foot sleeve 512 is configured to support the inflation bladder 534. This configuration of the foot sleeve 512 has the advantage of engaging the foot F and increasing the circulation of the limb blood vessels.

  Needless to say, various modifications can be made to the embodiments disclosed herein. Therefore, the above description should not be construed as limiting, but merely as exemplifications of various embodiments. Those skilled in the art will envision other modifications within the scope and spirit of the claims appended hereto.

The objects and features of the disclosure believed to be novel are set forth with particularity in the appended claims. The present disclosure, both in terms of operation schemes and techniques in conjunction with further objects and advantages, may be best understood by reference to the following description, taken in conjunction with the accompanying drawings, described below.
FIG. 1 is a plan view of one particular embodiment of a compression device according to the principles of the present disclosure, showing an inflatable bladder and a foot in broken lines. 1A is a partial cross-sectional view of the compression device shown in FIG. FIG. 2 is a cut-away sectional view of the strap of the compression device shown in FIG. 3 is a cut-away cross-sectional view of an alternate embodiment of the strap of the compression device shown in FIG. FIG. 4 is a plan view of an alternative embodiment of the compression device shown in FIG. 1, with the inflating bladder shown in broken lines. FIG. 5 is a plan view of another alternative embodiment of the compression device shown in FIG. 1, with the inflation bladder shown in broken lines. FIG. 6 is a plan view of another alternative embodiment of the compression device shown in FIG. 1, with the inflating bladder shown in broken lines. FIG. 7 is a plan view of another alternative embodiment of the compression device shown in FIG. 1, with the inflating bladder shown in broken lines.

Claims (23)

Compression device:
An expandable body that can be placed around the foot;
A strap extending from the main body and configured to be disposed around the foot near the ankle;
The compression device has a first layer, a second layer configured to engage an outer surface of the foot near the ankle, and a third cushion layer disposed between the two layers. The strap is integrally connected to the body;
The compression device of claim 1. The strap is formed integrally with the body;
The compression device of claim 1. The body includes the first layer;
The compression device of claim 1. The body includes the second layer;
The compression device of claim 4. The strap has a segment configuration that follows the foot,
The compression device of claim 1. The third cushion layer is disposed within the first layer and the second layer such that the first layer and the second layer are configured to provide a protective layer to the third cushion layer. ,
The compression device of claim 1. The body includes a metatarsal strap;
The compression device of claim 1. The first layer comprises a soft material;
The compression device of claim 1. The first layer comprises a soft material and a flexible membrane;
The compression device of claim 1. The third cushion layer includes a foam material;
The compression device of claim 1. The second layer has an outer surface on which a loop material is disposed;
The compression device of claim 1. The second layer includes an outer surface on which a flexible membrane and a loop material are arranged.
The compression device of claim 1. The second layer has an outer surface comprising a loop material, and the metatarsal strap includes a hook element engageable with the loop material to attach the expandable body to the foot;
The compression device of claim 8. The body includes a hook element engageable with the loop material for attaching the expandable body to the foot;
The compression device of claim 12. Compression device:
A foot sleeve including an inflatable body configured to be positioned around the foot and including a metatarsal bone portion;
A strap that is integrally connected to and extends from the ankle sleeve and is configured to be disposed around the ankle near the ankle;
The strap has a first layer configured to engage an outer surface of the foot near the ankle, a second layer, and a third cushion layer disposed between the two layers, thereby A compression device, wherein the first layer and the second layer are configured to provide a protective layer to the third cushion layer. The first layer is configured to prevent the third cushion layer from engaging the outer surface of the foot;
The compression device of claim 16. The third cushion layer includes a foam material;
The compression device of claim 16. The strap has a segment configuration that follows the foot,
The compression device of claim 16. Compression device:
A foot sleeve including an inflatable bladder configured to be positioned around the foot and including a metatarsal portion lying on the foot;
A strap that is integrally connected to and extends from the ankle sleeve and is configured to be disposed around the ankle near the ankle;
The strap has a foot contact layer comprising a soft material configured to engage the outer surface of the foot near the ankle, an outer layer, and a cushion layer comprising a foam material disposed between the two layers; Thereby, the foot contact layer and the outer layer are configured to provide a protective layer to the cushion layer, the outer layer having an outer surface including a loop material, whereby the metatarsal bone portion is A compression device comprising a hook element engageable with the loop material for attaching a foot sleeve to the foot. The compression device includes a plurality of straps extending from the body;
The compression device of claim 1. Compression device:
An expandable body configured for placement around the foot and including an upper layer and a lower layer; and
A strap member extending from the expandable body, a portion of the strap member being disposed between the upper layer and the lower layer of the expandable body; The strap member includes a plurality of layers, and the plurality of layers includes a cushion layer disposed therein.
23. The compression device of claim 22.

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