JP7203853B2 - Medical pressure therapy equipment and its components - Google Patents

Description

[2] The present disclosure relates generally to medical devices for applying pressure therapy.

[4] Many medical conditions can be treated by the controlled application of pressure to the patient's body. A medical professional or emergency medical professional may apply pulsatile pressure to the patient's body, such as by massage, to increase blood velocity at or adjacent to the area where the pulsatile pressure is applied. This pressure therapy increases peripheral and/or lymphatic circulation, promotes blood flow, provides redistribution of blood flow and diffusion, heals tissues by increasing blood flow (e.g., wound healing and new Promoting growth of blood vessels) as well as increasing the flow of substances between blood vessels and cells through increased diffusion can provide several benefits.

[5] These effects include open wounds, chronic ulcers, burns, skin grafts, diabetic ulcers, edema, pain, conditions caused by inactivity, spinal cord injury, lymphedema, atherosclerosis, stroke, and heart attack. , or as part of a treatment regimen for patients suffering from conditions such as cancer.

[6] Pressure therapy is also used in combination with external heating or cooling to help rapidly regulate a patient's body temperature to treat patients suffering from overheating or overcooling, such as heatstroke or hypothermia. Used often. Pulsatile pressure increases the rate at which temperature changes to the patient's limb are transmitted to the patient's core, and regulates the patient's core temperature more effectively than if the patient's limb were heated or cooled without pressure therapy. can be done.

[7] In other situations, it may be desirable to heat or cool the patient for therapeutic purposes as well. Such situations may be during chemotherapy, before, after, or during surgical intervention, and metabolism should be decreased, for example, during stroke or cardiac arrest. In other situations, it may be desirable to prewarm the patient prior to anesthesia in order to prevent or reduce hypothermia.

[8] In its most basic form, a trained medical professional can apply pressure therapy in the form of manual massage, but efforts have been made to improve and automate pressure therapy with pressure therapy devices. . These devices can apply more precise pressure levels than massage and can use both negative and positive pressure on the limb during treatment.

[9] However, the use of pressure therapy devices is relatively new in clinical practice and several improvements or advancements beyond the general application of pressure to a portion of the limb have been identified. There remains a need to develop new features in pressure therapy devices for increasing blood flow.

[10] To apply pressure to a patient's body, known pressure therapy devices typically place a controlled pressure environment, such as a pressure chamber, around the area of the user where the pressure is to be controlled. Establish The pressure can then be regulated within the closed environment of the pressure chamber by removing or adding air to the chamber.

[11] If pulsatile pressure is to be applied to a patient's leg, for example, a controlled pressure environment can be established around the patient's leg and from the calf to the thigh. This may involve positioning the patient's leg in a pressure chamber that isolates at least a portion of the leg from the surrounding environment.

[12] Because users requiring medical pressure therapy often suffer from limited mobility and flexibility due to advanced age or other debilitating conditions such as those described above, Proper placement of a patient's limb is often difficult. Known pressure systems are also often bulky, difficult to adjust, complicated to operate, and require the assistance of a trained medical professional to use safely and effectively.

[13] During the application of negative pressure in known devices, the negative pressure environment created inside the pressure chamber can draw the patient's limb deeper into the pressure chamber and against the inner edge or surface of the device. This can create pressure points on the patient's limb, potentially restricting blood circulation through the patient's limb, causing bruising, discomfort, necrosis, or other undesirable effects. There is

[14] Patients suffering from the conditions listed above also often have fragile skin, which can be damaged unless properly protected from edges and protrusions. As the patient's limb is drawn into the closed end of the pressure chamber, contact between the patient's limb and the walls of the pressure chamber can create high pressure points of contact that can damage fragile skin. This may pose a particular risk to patients with neuropathy and/or restricted cutaneous blood flow.

[15] In other devices, the limb is supported or protected by a padding structure that must be custom-fitted or custom-shaped to the individual user to provide adequate support and avoid pressure points on the limb. obtain. Individual fittings require additional time, materials, and the assistance of a trained technician. Alternative methods in the prior art may involve constructing pressure chambers on or to fit the limb, which are similarly expensive and difficult to construct.

[16] The sealing of the pressure chambers around the patient's limbs is associated with irregular variations in the user's anatomy and a large opening to allow leg insertion with limited ankle mobility. Combined with the need to have, it is equally difficult. Prior art methods often require sealing components that are resilient under high tension, which are often uncomfortable, often require assistance to apply, and create pressure points on the skin. It can be difficult to trigger and adjust for the user.

[17] From the above, known negative pressure systems are not configured for use by inexperienced patients, and adequate levels of pressure are generated without damaging the patient's fragile limbs, Special fittings, complex components and pressure generators may be required to ensure release. These complex systems are often expensive to manufacture and prohibitively expensive to use on a consumer scale.

[18] There are concerns that the difficulty of using known pressure therapy devices may discourage patients from receiving necessary treatment. There is also concern that pressure therapy equipment may be used incorrectly at ineffective and/or potentially harmful pressure levels or limb placements without intervention from a trained technician.

[19] To provide only a few size components for pressure therapy equipment, minimizing the need for customization while increasing support for the patient's limb and maximizing exposure of the limb to pressure therapy. is desirable. A medical treatment that allows easy placement and adjustment of pressure chambers around the limb, including means for sealing the limb and applying pressure therapy to the limb while improving the efficacy of pressure therapy actuated by devices on the limb. A pressure therapy device is needed.

[20] Furthermore, it is desirable to provide a pressure therapy device with safety features that ensure that the device operates simply and safely both within and outside the clinical environment and that is inexpensive to manufacture.

[21] Similarly, there is a need for pressure therapy devices capable of more sophisticated capabilities that do more than simply apply negative or positive pressure to a portion of the limb.

[23] According to embodiments described herein, a pressure therapy device is arranged to provide pressure therapy to a limb of a user, particularly a patient. Pressure therapy devices allow pressure to be applied to the limb within an enclosed environment while providing a superior comfortable fit, safety features, improved support, and easy placement of the limb. .

[24] Pressure therapy device improvements over prior art devices and methods may include novel components that include pressure chambers, seals, inflatable pads, and internal positioning mechanisms for supporting a patient's limb. . Pressure therapy devices can also be provided with novel pumping units and valve systems configured to improve the safety and usability of the device.

[25] Indications for pressure therapy devices include open wounds, diabetic ulcers, conditions caused by inactivity, spinal cord injury, lymphedema, atherosclerosis, heat stroke, hypothermia, stroke, heart attack, and bone fractures. , inflammation, swelling, tendonitis, muscle injury, or cancer.

[26] Various embodiments of pressure therapy devices provide significant improvements over known pressure therapy devices in the donning and fitting process. The wearing and fitting process can be done without measurements and depending on the user's anatomy and physical capabilities. In particular, embodiments according to the present disclosure allow the patient to apply and fit the device without assistance.

[27] The pressure therapy device is further configured to fit an individual patient's size and shape without intervention from a technician or other professional, whereby the device is designed for optimal fit and performance. Customized.

[28] Embodiments of the present disclosure are streamlined including large openings and angled necks to facilitate insertion of the limb without flexion of the joint and to allow a relaxed position for the limb during use. may include a pressure chamber having the characteristics of The bottom surface of the pressure chamber may be made of molded material and provided with a flat bottom with slanted edges.

[29] A pressure therapy device may be arranged to be adjustable by the user in a sitting position by providing a means to lift and rotate the device from a distance, and compared to known devices, Increases user ease and comfort during use. Pressure therapy devices may be adapted to cooperate with external support mechanisms to maintain or reposition the device in a preferred position.

[30] These features reduce the weight, size, and bulk of known pressure therapy devices and allow the device to be worn without requiring excessive exertion or flexion and rotation of the limb.

[31] According to one embodiment of the pressure therapy device, the pressure therapy device includes a pressure chamber having a first end and a second end, and an anterior exterior surface and a posterior exterior surface. The first end defines an opening configured to extend from a receiving area to a pressure area adapted to receive and enclose a limb.

[32] While prior art devices often have a distinct boot shape that narrows at the user's ankle or lower leg, embodiments of the present disclosure may include oversized openings and interior regions. The opening may be configured to be of a predetermined size that extends into the receiving area and forms a short "neck" before expanding into the interior of the pressure chamber so that the limb is difficult for the user to reach. Or it can be passed without rotation or flexion of the limb, which is often painful. The user's foot and lower leg can be inserted through the pressure chamber opening and neck at a 90° angle without rotation or flexion of the ankle.

[33] The front and rear exterior surfaces of the pressure chamber are such that the distance between the front and rear surfaces increases at a predetermined rate along the height of the pressure chamber toward the second end of the pressure chamber. , can form a certain angle. This arrangement allows the wide opening to extend over a wider area within the chamber without a tight angle, especially in the front face.

[34] According to an embodiment of the pressure chamber, the forward face may be configured to be straight and extend at an angle from the neck of the opening of the pressure chamber. The straight surface advantageously allows the user to move the foot and lower leg at a 90° angle without the user's toes contacting the surface of the pressure chamber, which can be painful or cause difficulty in donning and doffing the device. Allows you to insert at an angle.

[35] The second end of the pressure chamber is closed by a support surface, the support surface having a flat portion and a corner at least at the rearward end. The corners and flats are adapted to allow angular adjustment and stable placement of the pressure chamber both during limb insertion and during device operation.

[36] The corner may be a heel rest to stabilize the pressure chamber in an upright position when the limb is inserted into or removed from the pressure chamber. With the pressure chamber in an upright position, the user can insert the limb without rotation or flexion of the limb. The user's feet and lower legs can be inserted from a sitting position by simply raising the leg and extending the knee, without rotating the ankle.

[37] When the limb contacts the underside of the pressure chamber, the pressure chamber may rotate forward to lie on the plateau for a stable, comfortable and consistent treatment position.

[38] The support surface may comprise a friction enhancing material, such as a rubber-like material, on its outer surface to prevent the pressure chamber from slipping during use.

[39] The outer surface of the pressure chamber may also be configured to be transparent and include markings for proper positioning of the limb so that the user may clearly see it when the limb is positioned. A clear view of limb positioning may lack the ability to feel pressure or contact on the limb and must be able to see a freely floating limb for use with neuropathies. It is beneficial for

[40] The forward outer surface may include a first locking element arranged to engage the adjustment piece. An adjustment piece may extend toward the first end of the pressure chamber for manipulation by a user and may be removably secured to the pressure chamber at a location near the opening to increase leverage. The adjustment piece could include a removable handle to allow the user increased control of the positioning of the pressure chamber during use.

[41] Embodiments of the pressure therapy device may secure and position the user's limb within the pressure chamber using an inflatable pad and seal positioned at a first end of the pressure chamber. The first end may include a second locking element for securing the inflatable pad through the opening and into the receiving area of the pressure chamber.

[42] The second locking element may be configured to engage a receiving element on the inflatable pad such that proper positioning of the inflatable pad is clear and repeatable to the user.

[43] A seal surrounds the opening of the pressure chamber and the inflatable pad and may be configured to engage the second locking element without an additional belt.

[44] In an embodiment, the inflatable pad engages a second locking element on the outer surface of the first end of the pressure chamber at a predetermined position and extends into the opening and receiving area of the pressure chamber. can exist. In an alternate embodiment, the inflatable pad may engage a second locking element on the inner surface of the first end of the pressure chamber.

[45] The inflatable pad may be deflated to allow insertion of a user's limb through the opening of the pressure chamber, and may be configured to assume a shape corresponding to the user's limb when inflated. In doing so, the inflatable pad may be further adapted to inflate and close the opening of the pressure chamber around the limb.

[46] The inflatable pad may be provided with a valve to inflate and deflate with limited intervention by the user. The valve inflates the inflatable pad in response to negative pressure in the pressure chamber by drawing air from the ambient environment into the inflatable pad, and deflates only when the valve is opened by the user or at predetermined intervals. It may be a check valve, check valve, or one-way valve adapted to do so.

[47] Using a one-way valve with negative pressure allows automatic inflation of the inflatable pad during operation of the pressure therapy device, surprisingly resulting in an additional massaging effect on the user's limb during therapy. was found to provide a The massaging effect is caused by the inflatable pad being closed against ambient pressure, whereby an overpressure is generated within the inflatable pad following the release of the negative pressure in the pressure chamber.

[48] If the negative pressure draws blood into the user's limb, the overpressure will e.g. , causing the inflatable pad to slightly compress or massage the user's limb. This compressing or massaging effect serves to accelerate the blood drawn into the user's limb by the negative pressure, increasing blood flow through the limb.

[49] The dual advantage of negative pressure around the limb combined with positive pressure applied by the inflatable pad is achieved simply by exploiting the existing dynamics between negative pressure and atmospheric pressure, That is, the introduction of negative pressure automatically inflates the inflatable pad. The massage effect is achieved without the need to generate positive pressure in the pressure chamber, allowing the pressure therapy device to apply both positive and negative pressure to the limb without complicated pumping systems.

[50] The valve of the inflatable pad may be configured as a lever-operated valve that opens when the seal is pulled away from the user's limb, as a timer valve, or as a manually-operated valve, thereby allowing the user to control the limb. The inflatable pad can be easily deflated to remove the from the pressure chamber.

[51] In alternative embodiments, the inflatable pad may be configured to communicate with the pump unit using a three-way valve or the like.

[52] The thickness of the material of the inflatable pad may be configured such that greater or lesser pressure or overpressure is applied to the limb. If the inflatable pad material is thicker or more resilient, the inflatable pad will resist expansion, while the opposite is true for thinner or flexible materials.

[53] In one embodiment, the inflatable pad comprises at least two air chambers so that the limb can be properly positioned in the pressure chamber. Using an inflatable pad with only one air chamber fills unevenly as the air in the pad will be redistributed according to the resistance provided by the limb. If the inflatable pad has only one air chamber, the pad may not properly position the limb, but the weight and position of the limb will cause the limb to rest against the side or back of the pressure chamber. can make it possible.

[54] The inflatable pad may comprise a seamless material, a single molded material, or a material having multiple welds. The inflatable pad may thereby present a smooth inner surface free of protrusions or recessed areas that may cause discomfort, dents, or marks on the user's skin.

[55] The inflatable pad may be made of PVC or PUR and may have a flocked surface. PUR materials are advantageous due to the increased friction offered against PVC or flocked materials. The inflatable pad provides different surface types or treatments, such as a sticky surface to better hold the user's limb, a smooth surface, or a padded surface to increase the user's comfort. can be

[56] In some configurations, the inflatable pad may have a uniform length or may better grip the posterior portion of the limb to better hold the limb on the resting side, e.g., the posterior side of the leg. It may have an anterior length that is shorter than the posterior length to support the body. The inflatable pad may also extend proximally beyond the pressure chamber opening to better grip the limb and protect the limb from the edges of the pressure chamber opening.

[57] In one embodiment, the inflatable pad has an extension of 5-20 mm beyond the upper edge of the pressure chamber to protect the limb from contact with the hard edge of the pressure chamber. obtain.

[58] The enclosure of the pressure therapy device surrounds the opening of the pressure chamber and the inflatable pad at the first end of the pressure chamber such that a portion of the user's limb is enclosed therein. Configured. The seal is configured to firmly grip the user's limb so that the interior of the pressure chamber can be isolated from ambient pressure.

[59] The closure may comprise a frusto-conical turn or cone made of a resilient material having first and second ends. A second end of the cuff may be adapted to engage the second locking element at the first end of the pressure chamber and as it expands away from the opening to the first end of the cuff. It can have a decreasing diameter. The first end of the cuff may be positioned eccentrically with respect to the second end such that the second end of the cuff is positioned eccentrically to naturally position the limb in a preferred position without user intervention. It has a central axis behind the central axis.

[60] Using a frusto-conical turn with a first end that is eccentric with respect to a second end allows the seal to easily conform to the irregular shapes of the user's anatomy. It has been found that it advantageously allows an intuitive adaptation. In particular, the described shape of the seal can close small depressions or grooves in the user's anatomy, such as are common on the anterior aspect of the lower leg, for example, where the tibia may protrude narrowly from the calf. .

[61] The surface of the seal may be a friction-enhancing material or a smooth surface to improve the seal on the limb and facilitate unrolling and securing of the seal around the opening of the pressure chamber during limb insertion. A surface can be provided. The second end of the closure may further be provided with a protrusion for securing the closure in an open or wrapped position.

[62] The seal preferably has a length sufficient to engage the patient's limb over a predetermined distance to ensure a good seal and prevent the formation of pressure points. The outer surface of the closure may be provided with markings for trimming or cutting to adjust the length of the closure or the diameter of the first end of the closure.

[63] Since the seal is configured to securely grip a user's limb, the outer surface of the seal includes pull tabs to facilitate intuitive grasping and opening of the seal by the user. can be provided.

[64] The closure may comprise a resilient material and may be configured to have a variable thickness such that the second end of the cuff is thicker than the first end. The thicker material on the second end allows for a more secure attachment to the pressure chamber, while the thinner material on the first end facilitates opening and unwinding of the closure by the user. to The closure may be manufactured by injection molding, where the injection point is the circumference of the second end of the cuff to avoid a single injection point and uncomfortable welded seams that are prone to tearing after repeated use. Prepare.

[65] Modular components may be added to certain embodiments of the medical pressure therapy device to allow the application of additional treatment options to the limb. Examples of modular components that may be coupled to pressure therapy equipment may include heating or cooling units, vibration units, electrical stimulation units, and the like. Modular components improve the efficacy of medical pressure therapy devices in treating certain conditions, including hypothermia, heat exhaustion, etc., and may be placed in modular spaces in the support surface of the pressure chamber. The module space can be configured to accept multiple interchangeable module components having different functions.

[66] In one embodiment of the pressure therapy device, the exterior of the pressure chamber is provided with a stabilizing structure to keep the pressure chamber in place, eg, to facilitate a seated position for the user. The stabilizing structure may be adjustable to different lengths and may comprise at least one stabilizing piece secured to the pressure chamber. The at least one stabilizing piece may be curved or straight and may cooperate with an adjustment mechanism provided on the pressure chamber.

[67] In other embodiments, the stabilizing structure may be separate from the pressure chamber, adjusted to the position of the pressure chamber, such as with a beanbag, sling, or inflatable pillow to keep the pressure chamber in place. can be configured.

[68] The pressure chamber may include a positioning mechanism within the pressure chamber to indicate and support proper positioning of the limb. The positioning mechanism can be configured to provide support to the arch of the foot without contacting the heel and ball of the foot.

[69] The use of a positioning mechanism has been shown to increase the utility of pressure therapy devices by facilitating consistent and correct positioning of the limb within the pressure chamber, and surprisingly, negative An additional massaging effect is achieved during the pressure cycle to push blood out of the vascular bed under the foot. The positioning mechanism may be configured to contact the user's limb only at certain points, such as the arch of the foot, to avoid wounds commonly found on the heel or sole of the foot.

[70] In an alternative embodiment, the positioning mechanism may be configured to extend from the pressure chamber in a releasable configuration such that when contacted by a user's limb, the mechanism moves away from the limb. to prevent the mechanism from contacting the limb after limb positioning is complete. Using a releasable positioning mechanism allows consistent placement of the limb while leaving the limb hanging freely within the pressure chamber. In another embodiment, the positioning mechanism may collapse in response to negative pressure.

[71] Such a free-hanging configuration may be advantageous when there is a wound on the bottom of the user's limb.

[72] According to an embodiment of the pressure therapy device, the pressure chamber is connected to a pump unit for providing non-atmospheric pressure within the pressure chamber. The pump unit may provide alternating pressures such that a first period of non-atmospheric pressure is followed by a second period of non-atmospheric or atmospheric pressure. Additional embodiments and descriptions can be found in U.S. Patent No. 7,833,179, issued Nov. 16, 2010; U.S. Patent No. 8,021,314 issued Sept. 20; U.S. Patent No. 8,361,001 issued Jan. 29, 2013; U.S. Patent issued Sept. 2, 2014 No. 8,821,422, and US Pat. No. 8,657,864, issued Feb. 25, 2014.

[73] The pump unit may include a first valve system configured to operate as a one-way valve with an arming feature. The first valve system may include a chamfered washer for closing the pipe or line. The chamfered washer may include a through hole and may be positioned against a resilient sheath configured to fit the tube and close the through hole of the chamfered washer.

[74] The chamfered washer and elastomeric sheath define a central opening to provide communication between the pressure area side of the tube or valve and the atmosphere or pump side. A sealing unit, such as a sphere, fits the dimensions of the central opening and is configured to seal the closed first valve system. Due to the chamfered edges and elastic covering, the closure unit can be designed with high tolerances while still preventing leakage.

[75] At a given pressure level, the sealing unit may be displaced from the central opening to allow communication to atmospheric pressure and prevent internal pressure from reaching unsafe levels. In the first valve system, the mass of the sealing unit and the size of the central opening calibrates the first valve system to a predetermined pressure range to prevent abuse or damage due to high pressure.

[76] The chamfered washer may define additional openings not defined by the elastic covering. In this configuration, the elastic covering acts as a one-way valve and opens additional openings or through-holes to allow air to be removed from the pressure area side during operation of the pump and the pump is in use. Seal the negative pressure on the pressure area side when not in use. Additional openings are closed by elastic coverings under negative pressure and openings under positive overpressure.

[77] The elasticity of the elastic covering may be configured to calibrate the first valve system to a predetermined pressure range. The elastic covering may also be pre-stretched to prevent movement or stretching of the covering into the central opening or additional holes.

[78] In one embodiment, the first valve system is configured to displace the sealing unit at predetermined times or in response to predetermined events to control the application and release of non-atmospheric pressure. A lever arm may be included. In one embodiment, the lever arm displaces the sealing unit when the pump unit is actuated so that the pump unit can remove air from the pressure area side, and when the pump unit is not actuated, the opening is sealed so that the opening is sealed. It can be adapted to release the closed unit.

[79] The first valve system or pressure chamber may also be provided with a permanent opening or leak valve. The leak valve is configured to provide a small opening to atmospheric pressure so that the pressure in the chamber will slowly adjust back to atmospheric pressure levels when the pump unit is not operating. The use of leak valves helps prevent abuse such as unsafe pressure levels and/or pressure levels maintained for unsafe periods of time.

[80] A similar leak hole may be provided in the inflatable pad and covered with tape to seal the hole so that in the event of a valve failure in the inflatable pad, the user may remove the tape. Remove and empty the inflatable pad.

[81] The pump unit may include a piston configured to generate a non-atmospheric pressure. The piston may include resilient extensions or vanes to increase design tolerances and reduce friction between the piston and cylinder. The wings may also be configured with a predetermined resilience such that the wings fold inward in response to a predetermined pressure, preventing unsafe pressure levels from occurring.

[82] The pressure therapy device may include a control unit including a processor and memory for operating the pump unit. The control unit may include sensors in pressure chambers or other components or on the user's limbs to monitor and record the results of therapy. The control unit may be programmed by the user or medical professional and provided with software to ensure compliance with the personalized treatment regimen.

[83] In one embodiment, the control unit may be configured to receive programming from removable memory, such as a flash drive, or to receive or communicate programming wirelessly. In this manner, a medical professional may access and update information stored by the control unit.

[84] A pressure therapy device may be provided as a kit including a combination of a pressure chamber, an inflatable pad, a pump unit, a control unit and/or a seal. The pressure therapy device can be configured by the technician or user to a particular user's needs and anatomy due to the advantageous configuration of each component.

[85] A method of using a pressure therapy device may comprise inserting a user's limb through an opening in a pressure chamber such that the pressure chamber, seal, and inflatable pad surround the limb. Upon insertion of the limb, the inflatable pad may be in a deflated state and the seal may be in a retracted or wrapped position so that there is space for the limb to pass through the opening of the pressure chamber without rotation of the limb.

[86] Inserting the limb may further include rotating the position of the pressure chamber such that the pressure chamber is in an upright position on the flat portion of the lower surface when the limb is inserted. The limb can then contact a positioning mechanism within the pressure chamber and the pressure chamber can be rotated to rest on the flat portion of the lower surface.

[87] The seal may then be expanded or deployed to fit against the limb of the user and cover the opening of the pressure chamber and the inflatable pad therein.

[88] Upon actuation of the pump unit, the pump unit draws air from the pressure chamber through a conduit in the pressure chamber. In response to negative pressure, the inflatable pad inflates through the valve and secures the limb in the opening of the pressure chamber, away from the rim and inner surface of the pressure chamber. Negative pressure also pulls the seal against the user's limb, isolating the interior of the pressure chamber from atmospheric pressure.

[89] Negative pressure is applied to the limb in a pulsatile manner, but the inflatable pad remains inflated, adding a good massaging effect to the limb during periods of overpressure.

[90] These and other features, aspects, and advantages of the present disclosure will become better understood with regard to the following description, appended claims, and accompanying drawings.

[92] Figure 1 shows a perspective view of a pressure therapy device. [93] Figure 2 shows a perspective view of a pressure chamber with and without an inflatable pad. [94] FIG. 3 shows a perspective view of a pressure therapy device with a seal in an extended position and a retracted position. [95] FIG. 4 shows a perspective view of a pressure therapy device configured with an adjustment piece and a method of attaching and detaching. [96] Figure 5 shows a perspective view of the adjustment of the seal around a patient's limb. [97] FIG. 6 shows a perspective view of a pressure therapy device having a stabilizing structure. [98] FIG. 7 is a plan view of a piston of the pump unit. [99] FIG. 8 is a plan view of the first valve system of the pump unit; [100] FIG. 9 is a plan view of a first valve system of a pump unit having a lever arm; [101] FIG. 10 is a perspective view of an image of a pressure therapy device having a stabilizing structure. [102] FIG. 11 depicts a perspective view of a seal for use with a pressure therapy device according to the present invention. [103] Figure 12 depicts a side perspective view of the closure of Figure 11; [104] Figure 13 depicts a top perspective view of the closure according to Figure 11; [105] FIG. 14 depicts an enlarged perspective view of at least one second locking element on the interior of the pressure chamber. [106] FIG. 15 depicts a plan view of an example of a hole corresponding to at least one second locking element. [107] FIG. 16 depicts a plan view of a positioning mechanism having a foldable configuration. [108] FIG. 17 depicts a perspective view of a pressure chamber having a positioning mechanism. [109] FIG. 18 depicts a side perspective view of a pressure chamber having a positioning mechanism. [110] FIG. 19 shows an enlarged perspective view of a piston having elastic vanes. [111] FIG. 20 depicts a side-by-side plan view of a valve in open and closed configurations. [112] FIG. 21 depicts a side perspective view of a pressure chamber having a lever-actuated valve mechanism. [113] FIG. 22 depicts a side perspective view of a pressure chamber having a timer valve mechanism. [114] FIG. 23 is a side-by-side detail view of a timer valve mechanism including a spring and rotary damper in an actuated state; [115] FIG. 24 is a perspective view of a pressure chamber system including a plurality of components. [116] FIG. 25 is a bottom perspective view of a pressure chamber having different angled portions on the rearward and forward sides. [117] FIG. 26 is a side view of the pressure chamber moved from an upright position by a user's limb to lie on the lower surface. [118] FIG. 27 is a perspective view of an inflatable pad. [119] FIG. 28 is a perspective view of a positioning mechanism.

[121] A better understanding of the different embodiments of the present disclosure may be obtained from the following description read in conjunction with the accompanying drawings, in which like reference characters refer to like elements.

[122] Numerous pressure therapy device embodiments and components for use therewith are described herein, with particular focus on devices and components directed to the limb. A limb can be any part of the human or animal body that can be easily plugged into the device. A limb may comprise an arm or leg, a portion of an arm or leg (eg, a forearm, hand, lower leg, or foot), or two or more of such portions of the body. Although pressure therapy devices are described within the context of preferred embodiments directed to the lower leg and foot, many of the features described herein are applicable to pressure therapy devices and components that immobilize other limbs and body parts. can be extended to

[123] Embodiments of pressure therapy devices and components for use therewith may be sized to accommodate different types, shapes, and sizes of human joints and appendages. Additionally, embodiments may be modified to direct the primary force exerted by the embodiment pressure system to any desired location. Embodiments can be further modified to secure the device on the limb at any desired location.

[124] For purposes of explanation, each pressure therapy device embodiment or component thereof described herein may be divided into sections denoted by general anatomical terms of the human body. Such anatomical terminology is provided to distinguish various elements of the device embodiments from each other, but they should not be considered limiting the scope of the present disclosure.

[125] Each of these terms is used, by way of example, with respect to the human leg divided into similar sections using a proximal-distal plane. The terms "proximal" and "distal" generally refer to the position of the device corresponding to the position of the leg relative to the point of attachment of the leg to the body. The terms "upper" and "lower" may be used in conjunction with "proximal" and "distal" to imply changes in position of "proximal" and "distal."

[126] Pressure therapy device embodiments can also be considered to be included within the "anterior" and "posterior" sections of the anterior-posterior plane. The anterior-posterior plane generally corresponds to the coronal or frontal plane of the human limb, which lies along the central longitudinal axis of the body. Thus, the posterior side or element is behind this anterior-posterior plane, whereas the anterior side or element is in front of the anterior-posterior plane.

[127] The terms "inwardly" or "medial" are used generally herein to distinguish the sides of the device that may be particularly adjacent to the limbs of the user of the device. Conversely, the terms "outer" or "outer" are used to indicate the side of the device as opposed to the inner side.

[128] According to embodiments of the present disclosure, pressure therapy devices are disclosed having advantageous configurations of pressure chambers, seals, inflatable pads, positioning mechanisms, pump units, and the like. Advantages of these embodiments are that the pressure therapy device is easy to move on the limb, simple and safe to operate by untrained users, and the efficacy of pressure therapy actuated by the device is high. is comfortable to use while improving

[129] FIG. 1 illustrates an embodiment of a pressure therapy device 100 having a pressure chamber 110 having a first end 114 and a second end 112 and an anterior surface 116 and a posterior surface 118. As shown in FIG. The front surface 116 may be provided with a first locking element 126 and the first end 114 defines an opening 120 to a receiving area 122 within the pressure chamber 110 that extends distally into the pressure area 124 . form.

[130] The pressure region 124 of the pressure chamber 110 may communicate with the pump unit 190 using a conduit 188 on the rear side 118 of the pressure chamber 110 . Embodiments of pressure therapy device 100 are not limited to any particular location of conduit 188 as long as conduit 188 communicates with pressure region 124 .

[131] The pump unit 190 may be any suitable device for generating a non-atmospheric pressure within the pressure region 124, such as a vacuum pump. In a preferred embodiment, the pump unit 190 includes additional safety and efficiency features such as a piston 200 for generating non-atmospheric pressure and a first valve system 210 for opening and closing the pressure chamber 110 from communication with ambient atmospheric pressure. function is provided.

[132] The inflatable pad 140 is secured to the opening 120 of the pressure chamber 110 and extends through the opening 120 into the receiving area 122 . Inflatable pad 140 is secured to pressure chamber 110 by at least one second locking element 136, as shown in FIGS. At least one second locking element 136 may be provided on the interior or exterior of pressure chamber 110 to lock the exterior surface of pressure chamber 110 before inflatable pad 140 extends through opening 120 into receiving area 122 . Hooks or extensions are provided for passing through corresponding holes in the inflatable pad 140 such that extensions overlapping 116, 118 may be included. The at least one second locking element 136 has an overall height of 1.5mm and may include a wide top or knob with a height of 0.5mm.

[133] A portion of the inflatable pad 140 provided with holes corresponding to the at least one second locking element 136 to better secure the pressure chamber 110 and provide an audible confirmation or snap to indicate proper attachment. Additionally, it can be reinforced by increasing the material thickness. Increased material thickness may be provided by a plastic or fabric band, such as Hostafan band 240 , secured to or incorporated into inflatable pad 140 . In one embodiment, a portion of inflatable pad 140 has a thickness of 0.35 mm. The hole may be configured in a shape corresponding to the second locking element 136, as demonstrated by the example of FIG.

[134] The inflatable pad 140 may comprise a stretchable or non-stretchable material such as thin polyurethane or PVC having a thickness of less than about 1 mm, and may include a padded felt or friction enhancing surface. The inflatable pad 140 can be made with a single mold or two welds to reduce the presence of seams that can cause pressure points or leave marks on the user's limb. The inflatable pad 140 may be provided with multiple chambers such that portions of the inflatable pad 140 are separately inflated around the user's limb.

[135] In one embodiment, the inflatable pad 140 may be formed from inner and outer sheets, such as TPU sheets, each forming a cylinder. The ends of the sheets are then welded together to form an air chamber therein. A band 240 and knob 242 may also be incorporated or attached thereon, as illustrated in FIG. Band 240 and knob 242 allow the user to secure inflatable pad 140 to pressure chamber 110 only in the correct configuration and remove inflatable pad 140 for cleaning or replacement.

[136] In the embodiment illustrated in FIG. 1, the inflatable pad 140 is inflated to grasp the limb of the user and narrow the opening 120 to a sealable dimension. The inflatable pad 140 allows the use of an exceptionally wide opening 120, without requiring excessive rotation or flexion of the limb, and while still allowing effective sealing of the pressure chamber 110, different Facilitate limb placement with size. Inflatable pad 140 is configured to inflate and adjust the size of opening 120 to the user's anatomy and compress around the limb.

[137] The inflatable pad 140 has a greater distal extension along the posterior side of the user's limb than along the anterior side because wounds are often more prevalent on the anterior side of the limb. can be configured as The reduced anterior to posterior distal extension also allows the user to adjust the limb during treatment, increasing user comfort. Since wounds are often more prevalent in the distal portions of the limb (e.g., the heel and ball of the foot), the distal extension is preferably designed so that the distal portion of the limb contacts the inflatable pad. restricted not to This arrangement allows the inflatable pad 140 to effectively guide and support the user's limb without putting undue pressure on sensitive or vulnerable areas.

[138] In one embodiment, the inflatable pad 140 may extend up to 20 mm proximally beyond the pressure chamber 110 to provide additional support and protection to the limb. Inflatable pad 140 has a distal extension more anterior than posterior to better grip the posterior side of the limb while exposing more of the limb to pressure within pressure area 124 . , can be configured to have variable lengths. The inflatable pad 140 may also be provided with strips of friction material to better grip the limb.

[139] Seal 150 is secured to pressure chamber 110, surrounds opening 120, and extends beyond pressure chamber 110 in a proximal direction. Seal 150 may be secured by at least one second locking element 136 or by friction, such as friction against the limb. Seal 150 may be provided with a narrow opening 155 (shown in FIG. 12) to aid in securing and positioning seal 150 . Seal 150 may comprise an elastic material with enhanced frictional properties such that seal 150 fits tightly around a user's limb.

[140] The seal 150 may comprise hot pressed silicon, TPE, or TBE having a thickness of about 1-2 mm. Seal 150 may be constructed of a material having a hardness within the range of 0-15 Shore A, more preferably about 5 Shore A, such that the material adheres to the user's limb without leaving an impression or mark. Stick firmly around it.

[141] As shown in FIGS. The proximal end 152 can have a central axis that is off-center relative to the central axis of the distal end 154 such that the limb is positioned by the posterior portion P of the opening 120, as shown in FIG. .

[142] When secured around a user's limb, the pull tab 157 extends along the distal length of the seal 150 to allow the user to grasp and open the seal 150 around the limb. may be configured to extend along. The proximal end 152 of the seal 150 can be unwound distally to widen the opening of the seal 150 for placement or removal of the limb. A protrusion 156 may be positioned on the distal end 154 to frictionally retain the seal 150 in the wrapped position so that the user does not have to hold the seal 150 down during placement of the limb. This feature allows use of pressure therapy device 100 by individuals who do not have sufficient strength, dexterity, or mobility to manipulate the seal while also moving the limb or pressure chamber 110 .

[143] In one embodiment, the seal 150 has a variable thickness such that the distal end 154 that secures to the pressure chamber 110 has a greater thickness, eg, 2 mm, than the proximal end 152, eg, 1 mm. can. The increased thickness of the distal end 154 ensures a more secure attachment to the pressure chamber 110, while the decreased thickness of the proximal end 152 allows easier adjustment of the seal 150 by the user. and positioning (such as by simply wrapping or unfolding the closure 150) and greater comfort for the user's limb.

[144] After placement of the limb, a seal 150 may be wrapped proximally around the limb to seal the pressure chamber 110 from ambient pressure, as shown in FIG. Seal 150 preferably has a length sufficient to contact the limb over a predetermined length to provide a strong pressure seal. In embodiments of pressure therapy device 100, seal 150 may be interchangeable with different sizes to fit different user or limb anatomy. The closure 150 may be provided with trimming marks 158 so that the closure 150 may be cut to the user's size.

[145] In one embodiment, the inflatable pad 140 may extend up to 20 mm proximally beyond the pressure chamber 110 to provide additional support and protection to the limb.

[146] As illustrated in FIGS. Support surface 130 may include a flat bottom 132 and corners 134 and may be molded as a separate piece secured to pressure chamber 110 . The flat bottom 132 allows the pressure chamber 110 to remain stable in place so that the user can sit comfortably while using the pressure therapy device 100 . Corners 134 may be present on front face 116 and rear face 118 so that pressure chamber 110 can be stably positioned in an inclined position. Corners 134 may be curved so that pressure chamber 110 may be easily rotated, or may be flat to provide stability in place.

[147] According to the embodiment of Figure 25, the rear corner 135 is flat and the front corner 133 is curved.

[148] As shown in FIG. 26, the pressure chamber 110 may be positioned to rest on the rear corner 135 in the upright position, the corners for stabilizing the pressure chamber in the upright position. heel rest, whereby the user can insert the limb into the pressure chamber without rotating or flexing the limb. The user's feet and lower legs can be inserted from a sitting position by simply raising the leg and extending the knee, without rotating the ankle. The limb can then contact the positioning mechanism 172 within the pressure chamber 110 and the pressure chamber 110 can be rotated to rest on the flat portion of the lower surface 130 .

[149] The support surface 130 may comprise a modular space for receiving one or more modular components 180. As shown in FIG. In one embodiment, module components may be replaceable and may include vibration components, heating components, cooling components, and the like.

[150] As shown in Figure 4, the adjustment piece 128 may engage the first locking element 126 to allow manipulation of the pressure chamber 110 from a distance, for example, from a seated position. . Pressure chamber 110 can then be lifted or rotated to allow the limb to pass through opening 120 without requiring any flexion or rotation of the limb.

[151] The positioning mechanism 172 may indicate to the user the correct positioning of the limb within the pressure chamber 110 so that the limb rests comfortably without contacting the walls or surfaces of the pressure chamber 110. FIG. Positioning mechanism 172 along with unrolled closure 150 , adjustment piece 128 , first locking element 126 , and corresponding receiving element 138 allow easy and precise placement of the limb within pressure chamber 110 .

[152] The positioning mechanism 172 is preferably positioned in the pressure chamber 110 such that contact with sensitive areas of the user's limb is avoided. As shown in Figure 28, the positioning mechanism 172 may be provided with a receiving element 175 such as a groove for locking to the bottom surface 130 of the pressure chamber. The bottom surface 130 of the pressure chamber 110 may have corresponding protrusions or locking elements. In one embodiment, the positioning mechanism 172 has a plurality of receiving elements corresponding to a plurality of projections on the bottom surface 130 of the pressure chamber such that the positioning mechanism 172 can be adjustable and secured to the pressure chamber at many positions. 175 is provided. A positioning mechanism 172 may be secured to the bottom surface 130 of the pressure chamber 110 .

[153] In one embodiment, the positioning feature 172 may have a shape that corresponds to the arch of the foot, as shown in Figures 17, 18, and 28, to improve user comfort and blood flow. A slight positive pressure massage can be provided to the feet to increase the In one example, the inner and outer sides of the positioning mechanism can have different heights and angles to more comfortably secure the user's limb in a preferred position. The positioning mechanism 172 may be provided with cavities, for example, to accommodate the flexibility of the positioning mechanism under the limb and/or to receive the water removal element 174 . Moisture removal elements 174 may include, for example, silica packets.

[154] In one embodiment, the positioning mechanism 172 may also provide a slight pressure during negative pressure cycles to push blood from the vascular bed under the legs toward the heart. A slight massaging effect will be experienced under the feet during the oscillating pressure cycle.

[155] The positioning mechanism 172 is configured in a predetermined shape, such as a narrow arch with a predetermined height, designed to avoid pressure under the toes, forefoot and heel where ulcers are often located. obtain. Any residual suction in the limb not compensated by the inflatable pad 140 will only cause the foot to flex upward (toes upward) and the heel will move slightly downward without contacting the bottom of the pressure chamber 110. Will.

[156] To provide the described massaging effect without allowing the limb to contact the bottom of the pressure chamber 110, the positioning mechanism 170 has a height of, for example, 7-10 cm. , may have slightly elastic arches. The positioning mechanism is strong enough to prevent the user's limbs from collapsing the positioning mechanism and contacting the pressure chambers, while increasing the massaging effect on the limbs to provide a comfortable rest. It may comprise polyurethane or other slightly elastic material that is also slightly elastic. The positioning mechanism may have a hardness of 30-50 Shore A, more specifically 45 Shore A.

[157] The positioning mechanism 172 is configured such that after contact with the limb, the positioning mechanism 172 is folded or retracted to ensure that the limb is freely positioned within the chamber, as shown in FIG. , may be storable. In another embodiment, positioning mechanism 172 may be configured to provide support to the user's limb throughout operation of pressure therapy device 100 .

[158] Preferably, the limb can be positioned in the pressure chamber 110 without contacting the pressure chamber 110, as shown in FIG. A wide opening 120 and a short “neck” or receiving area 122 combine to facilitate entry of the limb so that the pressure chamber 110 is positioned between the adjustment piece 128 and the support until the limb contacts the positioning mechanism 172 . Advantageous use of face corners 134 may be manipulated to "pass" over the user's limb. Positioning the limb in this manner allows the user to position the limb without requiring significant exertion or difficulty, preventing pressure points or skin injuries while allowing a larger portion of the limb to undergo pressure therapy. ensure exposure to

[159] In one example according to Figure 4, the pressure chamber 110 may be configured to have a shape similar to a boot for receiving the foot. In contrast to a normal boot, the pressure chamber 110 has streamlined features including a wide opening, a short neck and a sloped front. The pressure chamber 110 can advantageously be passed over the user's foot without flexing or rotating the ankle or other joint, which can be difficult or painful for the user.

[160] The pressure chamber 110 may be configured to be assembled or closed around the limb. A pressure chamber 110 configured to be assembled or closed around the limb offers the same advantages of limited flexion or rotation of the limb, but is more difficult to implement and requires less effort to manufacture and seal the pressure chamber 110. is more complicated. A pressure chamber 110 having a preferably wide opening 120 and a short receiving area 122 is preferably used for inserting the limb.

[161] A stabilizing structure 170 may extend from the pressure chamber 110 to position the pressure chamber 110 and support the limb in a particular position, eg, a resting position. The stabilizing structure 170 may support the user's limb in a reclining position or assist the user in initially positioning the limb within the pressure chamber 110 to provide comfort during use. Preferably, the stabilizing structure 170 is adjustable to different lengths and positions.

[162] Although shown as a single straight piece in FIGS. It may be storable within 110 or separable therefrom. In one embodiment, stabilizing structure 170 may comprise at least one elastic curve extending from pressure chamber 110 and may be adjustable to different positions or curvatures. The stabilizing structure 170 facilitates use and positioning of the pressure therapy device 100 by the user and helps avoid pressure points or discomfort by helping the pressure therapy device 100 to be properly supported.

[163] As shown in FIG.

[164] As shown in FIG. be done. Anterior side 116 of pressure chamber 110 may be configured to be largely straight to facilitate passage of the limb through opening 120 and the receiving space without bending or rotating the limb. In certain embodiments, the rearward side 118 of the pressure chamber 110 may extend beyond the extension of the forward side 116 .

[165] The pressure region of the pressure chamber 110 may communicate with the pump unit 190 using a conduit 188 on the rear side 118 of the pressure chamber. Device embodiments are not limited to any particular location of conduit 188 as long as conduit 188 communicates with pressure region 124 .

[166] As shown in FIGS. As piston 200 moves within cylinder 204 , non-atmospheric pressure is generated within pressure chamber 110 . The vanes 202 reduce friction between the piston 200 and the cylinder 204 such that the resistance of the cylinder 204 to movement of the piston 200 is reduced, thereby moving the piston 200 to generate non-atmospheric pressure. reduce the mechanical requirements for

[167] Because the piston 200 is not in direct contact with the cylinder 204, design tolerances are increased and the piston 200 and/or cylinder may be shaped to remove the molded part from the mold rather than being a "perfect" cylinder shape. can be manufactured by injection molding, which requires a slightly conical shape to allow for The sides of the molded part may have an inclination angle of 0.2 degrees, forming a slightly conical shape.

[168] Prior art methods for making the vaned 202-less piston 200 described typically require more precise components and more expensive materials such as metal. The use of injection molded parts according to the present disclosure allows piston 200 and/or cylinder 204 to each be produced as a single injection molded part, resulting in reduced cost of materials and precision required in manufacturing. This is particularly advantageous due to the cost of producing components that require a precise fit, and the use of vanes 202 increases tolerances for different sized components, which reduces manufacturing process costs and Simplify complexity and reduce cost of piston 200 and cylinder 204 .

[169] In one embodiment, the vanes 202 may comprise a resilient material to adjust to the dimensions of the piston 200 and the cylinder 204. As shown in FIG. Using resilient vanes 202 allows piston 200 to be adjusted to different dimensions of cylinder 204 . The adjustable nature of the piston 200 and resilient vanes 202 allows for the manufacture of low cost cylinders 204, particularly molded cylinders where the first end of the cylinder can have a larger diameter than the second end. . In one embodiment, the first end of cylinder 204 may form an angle of up to 3 degrees with the second end. The resilient vanes 202 are configured to have sufficient length and resilience to seal the cylinder 204 along its entire length.

[170] Referring to Figure 8, a first valve system 210 for opening and closing communication between the pressure region 124 and ambient atmospheric pressure is illustrated. A first valve system 210 may include an enclosed passageway 212 that communicates with pressure region 124 and ambient atmospheric pressure. As shown, the passageway 212 may include an ambient atmospheric pressure side elastic covering 216 and a pressure area side chamfered washer 214 , wherein both the elastic covering 216 and the chamfered washer 214 are elastic at the chamfered washer 214 . A central opening 218 is defined that is wider than the covering portion 216 . A sealing unit 220 is positioned within the passageway 212 on the pressure area side of the chamfered washer 214 .

[171] According to one embodiment, the sealing unit 220 may include a sphere having dimensions configured to close the central opening 218 by contact with the chamfer washer 214 and the resilient covering 216. As shown in FIG. The contact of the elastic covering 216 with the sealing unit 220 increases the design tolerances of the sealing unit 220 and improves the sealing of the central opening 218 .

[172] When creating a negative pressure in the pressure area 124, the sealing unit 220 lifts the sealing unit 220 out of the central opening 218 to a predetermined pressure that allows communication between the pressure area 124 and the ambient atmospheric pressure. Keep central opening 218 closed until . The pressure area 124 can be configured to have a maximum safe pressure by adjusting the mass of the sealing unit 220, the elasticity of the elastic covering 216, and the dimensions of the central opening 218. In a preferred embodiment, the sealing unit 220 is removed from the central opening 218 with a pressure of 60-150 mmHg, more specifically 60-75 mmHg.

[173] The chamfered washer 214 may include additional openings 215 positioned in the sides of the chamfered washer 214 to open the elastic covering 216 in response to overpressure. The first valve system 210 operates as a safety valve.

[174] The elastic covering 216 may be pre-stretched and fixed in the passageway 212 by the chamfered washer 214 and the wall of the passageway 212 . As illustrated in FIG. 8, the elastic covering 216 is fixed in place and cannot be moved or withdrawn through the central opening 218 in response to negative pressure. .

[175] As shown in FIG. 9, the first valve system 210 may include a lever arm 222 configured to displace the sealing unit 220 at a predetermined time or in response to a predetermined pressure. . When the lever arm 222 displaces the sealing unit 220, the pressure chamber 110 communicates with ambient pressure and the internal pressure of the pressure chamber can be regulated to the ambient pressure.

[176] A preferred method of use of the pressure therapy device 100 is pressure therapy on a user's limb. Pressure therapy may involve the application of pulsatile pressure or the repeated, alternating introduction of two or more different pressures for successive periods of time. In one example, the pulsating pressure can comprise alternating introduction of applied pressure and release of applied pressure to return to approximately atmospheric pressure. The applied pressure can be positive or negative. In embodiments using negative pressure, the period during which negative pressure is introduced and present is the negative pressure period. Similarly, in systems utilizing positive pressure, the period during which positive pressure is introduced and present is the positive pressure period. In either case, the period during which the applied pressure is released and atmospheric pressure is returned and present is the atmospheric pressure period.

[177] The embodiments discussed herein are discussed with reference to an applied negative pressure. Typically, a negative pressure system can be easily replaced with a positive pressure system by reversing the operation of the pumps and valves or by other adjustments apparent to those skilled in the art. It should be understood that any discussion of negative pressure systems applies equally to positive pressure systems unless otherwise stated. In such cases, the term "negative pressure" as used herein should be replaced with the term "positive pressure", and pressure values should likewise be replaced. The present disclosure should not be construed to exclude devices and methods that use positive rather than negative pressure.

[178] In some embodiments, multiple successive alternating periods of negative pressure and atmospheric pressure are applied to the limb within the chamber without removing the limb from the pressure chamber. The negative pressure period and the atmospheric pressure period can be of the same duration or different durations. In some embodiments, the negative pressure period and the atmospheric pressure period are according to known methods, such as those described in commonly owned U.S. Patent Application Publication No. 2005/0027218, published Feb. 3, 2005. can be selected.

[179] In some embodiments, the negative pressure period is from 1 second to 20 seconds in duration and the atmospheric pressure period is from 2 seconds to 15 seconds in duration. Further, in some embodiments, the negative pressure period is 5 seconds to 15 seconds in duration and the atmospheric pressure period is 5 seconds to 10 seconds in duration. And, in some preferred embodiments, the negative pressure period is about 10 seconds in duration and the atmospheric pressure period is about 7 seconds in duration.

[180] The pressure applied within the pressure chamber can be fixed or selected at the time of use. Embodiments of devices and methods according to the present disclosure provide for applying a negative pressure of -150 mmHg or less, more specifically -80 mmHg (-10.7 kPa) or less. The corresponding pressure chamber is configured to withstand a further negative pressure of at least -80 mmHg (-10.7 kPa), preferably more. In some embodiments, the negative pressure can be -60 mmHg (-8.0 kPa) or less. Some embodiments utilize a negative pressure of approximately -40 mmHg (-5.3 kPa). The preferred negative pressure is selected to reduce possible complications from applying higher negative pressure. In some embodiments, the negative pressure is selected to promote local vasodilation at the surface of the limb while minimizing the risk of possible complications. Pulsating negative pressure has been found to promote blood flow, and a pulsating negative pressure of 0 to -40 mmHg (0 to -5.3 kPa) is preferably generated in the pressure chamber.

[181] According to one embodiment of the device of Figures 20 and 27, the inflatable pad 140 is configured with a valve 192, preferably a one-way or check valve, for providing communication with ambient atmospheric pressure. be done. A valve 192 may be positioned to surround an opening in inflatable pad 140 and extend through the side of pressure chamber 110 in a locking knob 242 that extends through an opening in pressure chamber 110 .

[182] In such embodiments, the inflatable pad 140 is inflated by applying a negative pressure within the pressure chamber 110 and does not require the use of any additional vacuum or pressure generating mechanism. Advantageously, when inflatable pad 140 is provided with valve 192 , inflatable pad 140 will inflate in response to negative pressure to secure the limb in place within pressure chamber 110 . Where the inflatable pad 140 is provided with multiple chambers, each chamber is provided with a valve or a three-way valve for independent inflation and deflation.

[183] Lever arm 222 may be positioned to displace sealing unit 220 during periods of atmospheric pressure and to retract during periods of negative pressure. According to one embodiment of the pressure therapy device 100, the lever arm 222 may be fixed to the motor of the pump unit 190 such that the motor's torque acts to cause the motor to drive the piston 200 to generate non-atmospheric pressure. The lever arm 222 is moved away from the central opening 218 when it is turned on, displacing the sealing unit 220 only when the motor is not in use.

[184] At the end of the negative pressure period and during the atmospheric pressure period within the pressure chamber 110, the inflatable pad 140 may provide overpressure to the user's limb. Overpressure results from the changing pressure within pressure chamber 110 that inflatable pad 140 cannot regulate due to closure of valve 192 . Overpressure on the user's limb can cause the application of a positive pressure of about 10 mmHg to the user's limb during atmospheric pressure periods, further increasing blood flow through the user's limb by direct mechanical force. .

[185] The inflatable pad 140 may be constructed of a thicker or thinner material to adjust and control the amount of overpressure applied to the limb. Inflatable pad 140 may have variable thickness to distribute pressure or overpressure unevenly to the limb. Areas of greater thickness may be arranged to contact areas requiring less pressure or compression, while areas of lesser thickness contact areas requiring more pressure. can be arranged as follows: Thickness can also be arranged based on required heat transfer properties or comfort needs.

[186] When in use, the inflatable pad 140 is inflated during periods of negative pressure to secure the user's limb within the pressure chamber 110 . To allow the user to remove the limb after use, the inflatable pad 140 is adapted to be deflated to relieve the pressure created during negative pressure periods of the pressure therapy device 100.

[187] To deflate the inflatable pad 140 and enlarge the opening 120 of the pressure chamber 110 for insertion or removal of a user's limb, the valve 192 may be a lever-operated valve 194, a timer valve 196, or a manual valve. An actuated valve (not shown) may be provided. According to FIG. 21, a lever actuated valve 194 may be provided on the exterior of the pressure chamber 110 such that the seal 150 in the unwound position actuates the lever to open the valve 192 . When the seal 150 is wrapped over the user's limb, the valve 192 returns to its closed position and can be inflated in response to negative pressure. According to FIG. 22, timer valve 196 may be provided on the exterior of pressure chamber 110 so that the user may activate the valve by pressing switch 198 .

[188] As shown in FIG. It is connected to the rotary damper 208 . Spring 206 and rotary damper 208 may be configured to actuate valve 192 for a predetermined amount of time to deflate inflatable pad 140 and remove the user's limb for a predetermined amount of time. can. A manually actuated valve may be provided with a button that the user can press to activate the valve 192 . The valve remains open as long as the user is pressing the button. For example, in embodiments having a three-way valve, valve 192 may also be connected to pump unit 190 to deflate inflatable pad 140 in a rapid manner.

[189] By providing a medical pressure therapy device according to embodiments of the present disclosure, it is difficult to customize for an individual user, has limited pressure therapy techniques, and is used with limited dexterity or physical strength. difficult for the patient to put on, uncomfortable due to contact between pressure points and pressure chambers and wounds or sores on the user's limbs, and build up of unhealthy levels or durations of non-atmospheric pressure The problem of pressure therapy equipment being dangerous due to is addressed. The pressure therapy device of the present disclosure advantageously allows the user to intuitively and accurately apply the device without clinician assistance. The device conforms to the user's dimensions through the action of the seal and the inflatable pad and prevents the device from contacting wounds on the surface of the user's limb. The device further has a unique valving arrangement that provides beneficial distribution of negative pressure around the limb and intermittent massage effect while automatically relieving harmful pressure levels or durations.

[190] A case study was used to demonstrate the efficacy of a pressure therapy device according to the present disclosure with positive initial results.

[191] In one such study, a pressure therapy device of the present disclosure was used to treat a sample group of 16 individuals with peripheral arterial disease, varying pressure levels on a user's limb. was analyzed. More than 90% of the sample group in the study suffered from mild claudication and were classified as stage II in the Fontaine stage of chronic limb ischemia.

[192] A pairwise comparison of the effects of pressure levels -10 mmHg, -20 mmHg, -40 mmHg, and -60 mmHg on leg and foot flow and laser Doppler flux measurements was performed and, as shown in Table I below, flow and statistically significant increases in Doppler flux were demonstrated.

[193] As demonstrated, an embodiment of a pressure therapy device utilizing a negative pressure of approximately -40 mmHg (-5.3 kPa) significantly improved blood flow through the extremities of patients with peripheral arterial disease. can be shown, thereby improving healing.

[194] An additional study examined the effects of pressure therapy devices of the present disclosure on individuals with severe lower extremity ischemia. These individuals suffer from a number of conditions including chronic pain and open wounds or ulcers in the lower extremities. In particular, individuals unsuitable or choosing not to undergo revascularization procedures, ie, angioplasty, vascular bypass, or other surgical intervention, were selected for treatment.

[195] Initial data from studies indicate that chronic wounds tend to worsen when revascularization options are not available, with 5/7 of the original wounds in the standard care group only 275% (SD 514%) on average. It increases in size, indicating the development of two new wounds. When the pressure therapy device of the present disclosure was used, wound healing was observed in 6/9 wounds present at the start of treatment, with a mean reduction in wound size of 19% (SD 78%).

[196] Along with changes in wound size, changes in wound care and management were also seen. The number of dressing changes per week to manage wounds increased from an average of 1.67 to 3.67 in the control group, whereas in the group treated with the pressure therapy device of the present disclosure: A reduction from 2.75 to 1.75 times per week was observed. Since each wound dressing requires both a physical cost per dressing and a dedicated vascular nurse or podiatrist to assist, this puts the pressure of the present disclosure over prior art methods. Demonstrate potential cost-saving benefits of therapeutic devices.

[197] Paw pain was recorded for participants on a visual analogue scale, with 0 representing no pain and 100 representing the worst possible pain. Paw pain was shown to increase slightly from 46 to 58 in the control group, but decreased from 48.75 to 45.25 in the group treated with the pressure therapy device of the present disclosure. Medication pain control was also shown to differ between the two groups, with a decrease in opioid analgesics in the treatment group versus the control group.

[198] The above case studies clearly demonstrate the benefits of treatment using pressure therapy devices of the present disclosure, including increased wound healing, reduced treatment costs, reduced pain, and reduced need for opioid use. are doing. Similar advantages do not appear to be achieved in the prior art.

[199] As is readily apparent from the foregoing discussion, the size, number, configuration, and location of medical pressure therapy devices and their components are custom manufactured for many different users with different sized joints and body parts. and the design can be adjusted to benefit from the present design. It is also understood that the arrangement of inflatable pads, seals, positioning mechanisms, and other components may be alternated from that shown to benefit users of different sizes and medical conditions.

Below, the invention described in the scope of claims before the amendment of the present application will be added.
[1] A pressure therapy device (100) comprising:
a pressure chamber (110) having a first end (114) and a second end (112), said first end (114) defining an opening (120);
an inflatable pad (140) including a valve (192) positioned in said opening (120) and in communication with ambient pressure;
a seal (150) secured to the first end (114) of the pressure chamber (110) for sealing the opening (120);
a pump unit (190) connected to said pressure chamber (110) and configured to generate a negative pressure within said pressure chamber (110);
wherein said inflatable pad (140) expands to narrow said opening (120) in response to said negative pressure generated within said pressure chamber by said pump unit (190); and A pressure therapy device (100) configured to be immobilized around a user's limb.
[2] The pressure therapy of [1], wherein the inflatable pad (140) is configured to expand due to overpressure upon completion of the negative pressure generation by the pump unit (190). Equipment (100).
[3] The inflatable pad (140) includes at least a front air chamber and a rear air chamber, the rear air chamber having a length greater than the front air chamber of the inflatable pad (140) [1 ] or [2].
[4] The pump unit (190) includes a first valve system (210) comprising a chamfered washer (214) and a resilient sheath (216) defining a central opening (218) in a passageway (212). The method of any one of [1] to [3], comprising a sealing unit (220) positioned on the chamfered washer (214) to close the central opening (218). pressure therapy device (100).
[5] The closure (150) comprises a frusto-conical turn having a first end (152) and a second end (154), the first end (152) comprising: The pressure therapy device (100) of any one of [1]-[4] having a central axis that is eccentric with respect to the central axis of the second end (154).
[6] The pump unit (190) includes a piston (200) and a cylinder (204), and the piston (200) has vanes (202) extending from the piston (200) to the cylinder (204). The pressure therapy device (100) of any one of [1]-[5], comprising:
[7] A method according to any one of [1] to [6], wherein the outer surface of said pressure chamber (110) is provided with a first locking element (126) for fixing to an adjustment piece (128) A pressure therapy device (100) as described.
[8] any of [1] to [7], wherein the second end (112) of the pressure chamber comprises a support surface (130) having a flat portion (132) and a corner portion (134); Pressure therapy device (100) according to claim 1.
[9] The pressure therapy device (100) of [8], wherein the interior of said support surface (130) comprises a positioning mechanism (172) for receiving a foot of said limb.
[10] The pressure therapy device (100) of [9], wherein the positioning mechanism (172) comprises a narrow arch shape corresponding to the arch of the foot.
[11] The first end (114) of the pressure chamber (110) has at least one second end (114) on the outer surface of the pressure chamber (110) for securing to the inflatable pad (140). A pressure therapy device (100) according to any one of [1] to [10], provided with a locking element (136).
[12] any one of [1] to [11], wherein the pressure chamber (110) is provided with an adjustable stabilizing structure (170) extending from the second end (112); A pressure therapy device (100) according to any preceding claim.
[13] said second end (112) of said pressure chamber (110) comprises a support surface (130) having a modular space configured to receive a plurality of modular components (180); [1] A pressure therapy device (100) according to any one of paragraphs -[12].
[14] The pressure therapy device (100) of [13], wherein the plurality of modular components (180) includes a heating unit, a cooling unit, a vibration unit, and/or an electrical stimulation unit.
[15] The pressure therapy device (100) of any one of [1]-[14], wherein the pressure chamber is provided with a conduit (188) in communication with the pump unit (190). .
[16] The front and rear exterior surfaces of said pressure chamber (110) are such that the distance between said front and rear exterior surfaces of said pressure chamber (110) is along the height of said pressure chamber (110). A pressure therapy device (100) according to any one of [1] to [15] forming a certain angle so as to continuously increase towards the second end (112). .
[17] of [1] to [16], wherein the forward outer surface is configured to be straight and extend at an angle from the opening (120) of the pressure chamber (110); A pressure therapy device (100) according to any one of the preceding paragraphs.
[18] of [1] to [17], wherein said inflatable pad (140) extends beyond said first end (114) of said pressure chamber (110) by a distance of 5 to 20 mm; A pressure therapy device (100) according to any one of the preceding claims.
[19] Said closure (150) comprises a first end (152) and a second end (154), said second end (154) extending in an extended configuration to said second end. The pressure therapy device of any one of [1] to [18], having at least one protrusion (156) for securing a portion (154) to said first end (152) ( 100).
[20] The closure (150) comprises a first end (152) and a second end (154), the second end (154) being connected to the first end (152). ), the pressure therapy device (100) of any one of [1]-[19].
[21] The pressure therapy device (100) of any one of [1]-[20], wherein the seal (150) comprises heat pressed silicone, TPE or TBE.
[22] The pressure therapy device (100) of any one of [1]-[21], wherein the seal (150) has a thickness of 1-2 mm.
[23] The pressure therapy device (100) of any one of [1]-[22], wherein the seal (150) comprises a material having a Shore A number within the range of 0-15. .
[24] The pressure therapy device (100) of [23], wherein the seal (150) comprises a material having a Shore A number of 5.
[25] The pressure therapy device (100) of any one of [1]-[24], wherein the valve (192) comprises a lever (194) for opening the valve to ambient pressure. .
[26] The pressure therapy device (100) of [6], wherein the vanes (202) of the piston (200) comprise an elastic material.
[27] The pressure therapy device (100) of [6], wherein the vanes (202) of the piston (200) are configured to flex in response to a pressure of 20-150 mmHg.
[28] The sealing unit (220) is configured to have a predetermined mass such that the sealing unit (220) is removed from the central opening (218) with a pressure of 20-150 mmHg; [4 10. The pressure therapy device (100) according to .
[29] The pressure therapy device (100) of [4], wherein the enclosure unit (220) comprises a steel ball.
[30] said first valve system (210) is a lever arm configured to displace said sealing unit (220) when said pump unit (190) is operated to generate non-atmospheric pressure; The pressure therapy device (100) of [4], provided with (222).
[31] The pressure therapy device (100) of [4], wherein the chamfered washer (214) is configured to define an additional opening (215) therethrough.
[32] The pressure therapy device (100) of [31], wherein the elastic covering (216) is configured as a valve over the additional opening (215).
[33] A method of using a pressure therapy device (100), the method comprising:
obtaining a pressure chamber (110) having a first end (114) and a second end (112), said first end (114) defining an opening (120); ,
providing an inflatable pad (140) in said opening (120) of said pressure chamber (110) containing a valve (192) in communication with ambient pressure;
a seal (150) secured to the first end (114) of the pressure chamber (110) for sealing the opening (120) and enclosing the inflatable pad (140); providing and said enclosure (150) is in an open configuration;
inserting a limb through the seal (150), the inflatable pad (140) and the opening (120) of the pressure chamber (110);
closing the seal (150) around the limb in the opening (120);
creating a negative pressure in the pressure chamber (110) to inflate the inflatable pad (140) and immobilize the limb in the opening (120);
A method.
[34] The method comprises:
releasing the negative pressure in the pressure chamber (110) and generating overpressure in the inflatable pad (140) for massaging the limb;
The method of [33], further comprising:
[35] The method of [33], wherein the inflatable pad (140) is provided with at least two air chambers.
[36] The method comprises:
actuating a lever mechanism (194) of the valve to deflate the inflatable pad (140);
The method of [35], further comprising:

Claims (31)

A pressure therapy device (100) comprising:
a pressure chamber (110) having a first end (114) and a second end (112), said first end (114) defining an opening (120);
an inflatable pad (140) including a valve (192) positioned in said opening (120) and in communication with ambient pressure;
a seal (150) secured to the first end (114) of the pressure chamber (110) for sealing the opening (120);
a pump unit (190) connected to said pressure chamber (110) and configured to generate a negative pressure within said pressure chamber (110), wherein said inflatable pad (140) is connected to said pump unit; configured to expand to narrow said opening (120) and to secure around a user's limb in response to said negative pressure generated in said pressure chamber by (190); A pressure therapy device (100). The inflatable pad (140) of claim 1 , wherein the inflatable pad (140) includes at least a front air chamber and a rear air chamber, the rear air chamber having a greater length than the front air chamber of the inflatable pad (140). pressure therapy device (100). Said pump unit (190) includes a first valve system (210) comprising a chamfered washer (214) and a resilient covering (216) defining a central opening (218) in a passageway (212) for sealing 3. The pressure therapy device (100) of claim 1 or 2 , wherein a unit (220) is positioned on the chamfered washer (214) to close the central opening (218). Said closure (150) comprises a frusto-conical turn having a first end (152) and a second end (154), said first end (152) being connected to said second end (152). A pressure therapy device (100) according to any one of claims 1 to 3 , having a central axis that is eccentric with respect to the central axis of the end (154) of the. Said pump unit (190) comprises a piston (200) and a cylinder (204), said piston (200) comprising vanes (202) extending from said piston (200) to said cylinder (204); Pressure therapy device (100) according to any one of claims 1-4 . Pressure therapy apparatus according to any one of claims 1 to 5 , wherein the outer surface of the pressure chamber (110) is provided with a first locking element (126) for fixing to the adjustment piece (128). (100). The second end (112) of the pressure chamber according to any one of the preceding claims, wherein the second end (112) of the pressure chamber comprises a support surface (130) having flats (132) and corners (134). pressure therapy device (100). 8. A pressure therapy device (100) according to claim 7 , wherein the interior of said support surface (130) comprises a positioning mechanism (172) for receiving a foot of said limb. 9. A pressure therapy device (100) according to claim 8 , wherein the positioning mechanism (172) comprises a narrow arch shape corresponding to the arch of the foot. Said first end (114) of said pressure chamber (110) is provided on the outer surface of said pressure chamber (110) with at least one second locking element ( 136), the pressure therapy device (100) according to any one of the preceding claims. The pressure of any one of claims 1 to 10 , wherein said pressure chamber (110) is provided with an adjustable stabilizing structure (170) extending from said second end (112). A therapy device (100). 12. The method of any of claims 1-11 , wherein the second end (112) of the pressure chamber (110) comprises a support surface (130) having a modular space configured to receive a plurality of modular components (180). A pressure therapy device (100) according to any one of the preceding claims. 13. A pressure therapy device (100) according to claim 12 , wherein said plurality of modular components (180) comprises a heating unit, a cooling unit, a vibration unit and/or an electrical stimulation unit. A pressure therapy device (100) according to any one of the preceding claims, wherein said pressure chamber is provided with a conduit (188) communicating with said pump unit (190). The front and rear exterior surfaces of said pressure chamber (110) are such that the distance between said front and rear exterior surfaces is said second distance of said pressure chamber (110) along the height of said pressure chamber (110). Pressure therapy device (100) according to any one of the preceding claims, forming a certain angle so as to continuously increase towards the end (112). 16. The method of any one of claims 1 to 15 , wherein said forward outer surface is configured to be straight and extend at an angle from said opening (120) of said pressure chamber (110). A pressure therapy device (100) as described. 17. Any one of claims 1 to 16 , wherein the inflatable pad (140) extends beyond the first end (114) of the pressure chamber (110) by a distance of 5-20 mm. A pressure therapy device (100) according to . Said closure (150) comprises a first end (152) and a second end (154), wherein said second end (154) extends to said second end (154) in an extended configuration. ) to said first end ( 152). Said closure (150) comprises a first end (152) and a second end (154), said second end (154) being the thickness of said first end (152). A pressure therapy device ( 100) according to any preceding claim, having a thickness greater than a thickness. A pressure therapy device (100) according to any preceding claim, wherein the seal (150) comprises heat pressed silicone, TPE or TBE. A pressure therapy device (100) according to any one of the preceding claims, wherein said seal (150) has a thickness of 1-2 mm. A pressure therapy device ( 100) according to any preceding claim, wherein said seal (150) comprises a material having a Shore A number in the range of 0-15. 23. The pressure therapy device (100) of claim 22 , wherein the seal (150) comprises a material having a Shore A number of 5. A pressure therapy device (100) according to any preceding claim, wherein said valve (192) comprises a lever (194) for opening said valve to ambient pressure. 6. The pressure therapy device (100) of claim 5 , wherein the vanes (202) of the piston (200) comprise an elastic material. A pressure therapy device (100) according to claim 5 , wherein the vane portion (202) of the piston (200) is configured to bend in response to a pressure of 20-150 mmHg. 4. The sealing unit (220) of claim 3 , wherein the sealing unit (220) is configured to have a predetermined mass such that the sealing unit (220) is removed from the central opening (218) with a pressure of 20-150 mmHg. pressure therapy device (100). 4. The pressure therapy device (100) of claim 3 , wherein the sealing unit (220) comprises a steel ball. The first valve system (210) includes a lever arm (222) configured to displace the sealing unit (220) when the pump unit (190) is operated to generate non-atmospheric pressure. 4. The pressure therapy device (100) of claim 3 , provided with a . 4. A pressure therapy device (100) according to claim 3 , wherein the chamfered washer (214) is configured to define an additional opening (215) therethrough. 31. Pressure therapy device (100) according to claim 30 , wherein the elastic covering (216) is configured as a valve over the additional opening (215).

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