JP2020534988A - Medical pressure therapy equipment and its components - Google Patents

Abstract

The pressure therapy device (100) includes a pressure chamber (110), an inflatable pad (140), a seal (150), and a positioning mechanism (172). The pressure chamber (110) has an inflatable pad (140) and an opening (120) arranged to accommodate the user's limbs. The inflatable pad (140) is inflatable to enclose the limb and secure it in place. The seal (150) covers the opening (120), including the inflatable pad (140) and limbs, to seal the pressure chamber (110) from ambient atmospheric pressure. The pump unit (190) is a first valve system (210) and piston provided to generate non-atmospheric pressure in the pressure chamber (110) and has a safety release function to prevent unsafe pressure levels. (200) is included. [Selection diagram] Fig. 1

Description

[2] The present disclosure generally relates 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 pulsating pressure to the patient's body, such as by massage, to increase blood velocity in or adjacent areas where pulsating pressure is applied. This pressure therapy increases peripheral and / or lymphatic circulation, promotes blood flow, results in redistributing blood flow and diffusion, and heals tissues by increasing blood flow (eg, wound healing and new). By promoting blood vessel growth) and increasing the flow of material between blood vessels and cells through increased diffusion, several benefits can be provided.

[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, heart attack. , Or can be used as part of a treatment regimen (regimen) for patients suffering from conditions such as cancer.

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

[7] In other situations, it may be equally desirable to heat or cool the patient for therapeutic purposes. Such situations can be during chemotherapy, before, after, or during surgical intervention, and metabolism should be reduced, for example, during seizures or cardiac arrest. In other situations, it may be desirable to pre-warm the patient prior to anesthesia to prevent or reduce hypothermia.

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

[9] However, the use of pressure therapy equipment is relatively new in clinical practice, and some improvements or advances have been identified that go beyond the general application of pressure to parts of the limb. There remains a need to develop new features in pressure therapy devices to increase blood flow.

[10] To apply pressure to the patient's body, known pressure therapy equipment typically has a controlled pressure environment, such as a pressure chamber, around the area of the user where the pressure will be controlled. To establish. The pressure can then be adjusted within the closed environment of the pressure chamber by removing or adding air to the chamber.

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

[12] Users in need of medical pressure therapy often suffer from limited mobility and flexibility due to old age or other debilitating conditions such as those described above, and thus in the pressure chamber. Proper placement of the patient's limbs is often difficult. Known pressure systems are also often large, difficult to adjust, complex to operate, and require the assistance of trained medical professionals for safe and effective use.

[13] During the application of negative pressure in a known device, the negative pressure environment created inside the pressure chamber can pull the patient's limbs deeper into the pressure chamber and with respect to the inner edge or inner surface of the device. This can create pressure points on the patient's limbs, potentially restricting blood circulation through the patient's limbs, causing bruising, discomfort, necrosis, or other unwanted effects. There is.

[14] Patients suffering from the conditions listed above also often have fragile skin, which can be damaged unless adequately protected from the edges and protrusions. When the patient's limb is pulled into the closed end of the pressure chamber, the contact between the patient's limb and the wall of the pressure chamber can create high pressure contact points that can damage fragile skin. This may impose certain risks on patients with neuropathy and / or restricted cutaneous blood flow.

[15] In other devices, the limb is supported or protected by a pad structure that must be custom-fitted or custom-molded to the individual user to provide sufficient support and avoid pressure points on the limb. obtain. Individual fittings require additional time, materials, and the assistance of trained technicians. Alternative methods in the prior art may include constructing a pressure chamber on or to fit the limb, which is also expensive and difficult to construct.

[16] Sealing of the pressure chamber around the patient's limbs creates a large opening to allow irregular variations in the user's anatomy and insertion of the leg with limited ankle mobility. In combination with the need to have, it is similarly difficult. Conventional methods often require elastic sealing components under high tension, which are often unpleasant, often require assistance to apply, and pressure points on the skin. It can be difficult to induce and adjust for the user.

[17] From the above, known negative pressure systems are not configured for use by immature patients and generate adequate levels of pressure 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 exorbitant for consumer scale use.

[18] There is concern that the difficulty of using known pressure therapy equipment can discourage patients from receiving the treatment they need. There is also concern that pressure therapy equipment may be used incorrectly at ineffective and / or potentially harmful pressure levels or limb placement without intervention from trained technicians.

[19] To increase support for the patient's limbs, maximize exposure of the limbs to pressure therapy, minimize the need for customization, and provide only a few sized components for pressure therapy equipment. Is desirable. Medical care that allows for easy placement and adjustment of pressure chambers around the limb, including means of sealing the limb and applying pressure therapy to the limb, while improving the efficacy of pressure therapy actuated by equipment on the limb. Pressure therapy equipment is needed.

[20] Further, it is desirable to provide a pressure therapy device having a safety function that ensures that the device operates easily and safely both inside and outside the clinical environment and that can be produced inexpensively.

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

[23] According to the embodiments described herein, the pressure therapy device is arranged to perform pressure therapy on the limbs of the user, especially the patient. The pressure therapy device allows pressure to be applied to the limbs in an enclosed environment, while providing excellent comfortable fit, safety features, improved support, and easy placement of the limbs. ..

[24] Improvements to pressure therapy equipment over prior art equipment and methods may include new components with pressure chambers, seals, inflatable pads, and internal positioning mechanisms to support the patient's limbs. .. Pressure therapy equipment may also be equipped with new pump units and valve systems configured to improve the safety and usefulness of the equipment.

[25] Indications for pressure therapy equipment are open wounds, diabetic ulcers, conditions caused by inactivity, spinal cord injury, lymphedema, atherosclerosis, heat stroke, hypothermia, stroke, heart attack, fractures. , Inflammation, swelling, tendinitis, muscle damage, or cancer.

[26] Various embodiments of pressure therapy equipment provide significant improvements over known pressure therapy equipment in the wearing and fitting process. The wearing and fitting process is performed without measurement and may depend on the anatomical structure and physical ability of the user. In particular, the embodiments according to the present disclosure allow the patient to wear and fit the device without assistance.

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

[28] The embodiments of the present disclosure are streamlined including a large opening and an angled neck to facilitate insertion of the limb without joint flexion and to allow a relaxed position for the limb during use. It may include a pressure chamber having the characteristics of. The bottom surface of the pressure chamber is made of molding material and can be provided with a flat bottom with sloping ends.

[29] Pressure therapy devices can be arranged to be adjustable by the user in a sitting position by providing a means for lifting and rotating the device from a distance, as compared to known devices. Increases user ease and comfort during use. The pressure therapy device may be adapted to work with an external support mechanism to keep or reposition the device in a preferred position.

[30] These features reduce weight, size, and bulk over known pressure therapy equipment and allow the equipment to be worn without the need for excessive exertion or flexion and rotation of the limbs.

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

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

[33] The anterior and posterior outer surfaces of the pressure chamber increase the distance between the anterior and posterior surfaces at a predetermined rate along the height of the pressure chamber towards the second end of the pressure chamber. As such, a particular angle can be formed. This arrangement allows the wide opening to extend to a larger area within the chamber, especially in the anterior surface, without narrow angles.

[34] According to one embodiment of the pressure chamber, the anterior surface may be configured to be straight and extend at a constant angle from the neck of the opening of the pressure chamber. A straight surface can advantageously be painful or cause difficulty in attaching and detaching the device, allowing the user to 90 ° the feet and lower legs without the user's toes touching the surface of the pressure chamber. Allows insertion at an angle.

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

[36] When inserting or removing a limb from the pressure chamber, the corner can be a heel rest to stabilize the pressure chamber in an upright position. With the pressure chamber in the upright position, the user can insert the limb without rotation or flexion of the limb. The user's legs and lower legs can be inserted from the sitting position by simply raising the legs and extending the knees without rotating the ankles.

[37] When the limb touches the underside of the pressure chamber, the pressure chamber can rotate forward to be located on a flat surface for a stable, comfortable and consistent treatment position.

[38] The support surface may be provided with a friction-enhancing material, such as a rubber-like material, on the 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 may include markings for proper positioning of the limb so that the user can clearly see it when it is positioned. Clearly visible limb positioning may lack the ability to feel pressure or contact with the limb and must be able to see the freely floating limb, use with neuropathy It is beneficial to the person.

[40] The front outer surface may include a first locking element arranged to engage the adjusting piece. The adjusting piece may extend towards the first end of the pressure chamber for user operation and may be removably secured to the pressure chamber in a position close to the opening to increase leverage. The adjustment piece may include a removable handle, allowing the user to increase control of the position of the pressure chamber during use.

[41] Embodiments of pressure therapy equipment may use inflatable pads and seals located at the first end of the pressure chamber to secure and position the user's limbs within the pressure chamber. The first end may include a second locking element for fixing the inflatable pad through the opening into the receiving area of the pressure chamber.

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

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

[44] In one embodiment, the inflatable pad engages a second locking element on the outer surface of the first end of the pressure chamber in place and extends into the opening and receiving area of the pressure chamber. Can exist. In an alternative 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 can be contracted to allow the user's limb to be inserted through the opening of the pressure chamber and can be configured to take a shape corresponding to the user's limb when inflated. In doing so, the inflatable pad can 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 for expansion and contraction 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 contracts only when the valve is opened by the user or at predetermined intervals. It can be a check valve, check valve, or one-way valve adapted to do so.

[47] The use of a one-way valve with negative pressure allows for automatic inflating of the inflatable pad during the operation of the pressure therapy device, and surprisingly, a further massage effect on the user's limbs during therapy. Was found to provide. The massage effect is caused by the inflatable pad being closed to ambient pressure, whereby an overpressure is generated in the inflatable pad following the release of negative pressure in the pressure chamber.

[48] When negative pressure draws blood into the user's limbs, overpressure occurs, for example, as the atmospheric pressure recovers, the user's limbs are released from the effects of negative pressure in the pressure chamber. Have the inflatable pad slightly compress or massage the user's limbs. This compression or massage effect helps accelerate the blood drawn into the user's limbs by negative pressure and increases blood flow through the limbs.

[49] The dual advantage of negative pressure around the limb combined with the positive pressure applied by the inflatable pad is achieved by simply utilizing 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 limbs without a complex pumping system.

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

[51] In an alternative embodiment, the inflatable pad may be configured to communicate with the pump unit, such as by using a three-way valve.

[52] The thickness of the inflatable pad material 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 elastic, the inflatable pad resists expansion, but vice versa for thin or flexible materials.

[53] In one embodiment, the inflatable pad comprises at least two air chambers so that the limbs can be properly positioned within the pressure chamber. Inflatable pads with only one air chamber are unevenly filled as the air in the pads will be redistributed according to the resistance provided by the limbs. If the inflatable pad has only one air chamber, the pad may not position the limb properly, but depending on the weight and position of the limb, the limb may be placed against the side or back of the pressure chamber. Can make it possible.

[54] The inflatable pad may comprise a seamless material, a single molding material, or a material having multiple welds. Thereby, the inflatable pad may exhibit a smooth inner surface without protrusions or recessed areas that may cause discomfort, indentation, or marks on the user's skin.

[55] The inflatable pad can be made of PVC or PUR and can have a flocked surface. PUR materials are advantageous due to the increased friction provided to PVC or flocked materials. Inflatable pads provide different surface types or treatments, such as sticky surfaces, smooth surfaces to better hold the user's limbs, or padded surfaces to increase user comfort. Can be.

[56] In some configurations, the inflatable pad may have a uniform length or grip the posterior portion of the limb better and better on the placement side, eg, the posterior side of the limb. It may have an anterior length shorter than the posterior length to support it. The inflatable pad can also extend proximally beyond the pressure chamber opening to better grip the limb and protect the limb from the edge 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 seal of the pressure therapy device surrounds the opening of the pressure chamber and the inflatable pad at the first end of the pressure chamber so that a portion of the user's limb is enclosed therein. It is composed. The seal is configured to firmly grip the user's limbs so that the interior of the pressure chamber can be separated from ambient pressure.

[59] The sealing portion may include a truncated cone-shaped fold or cone made of elastic material with first and second ends. The second end of the fold can be adapted to engage the second locking element at the first end of the pressure chamber as it expands away from the opening to the first end of the fold. It may have a decreasing diameter. The first end of the fold can be positioned eccentrically with respect to the second end and of the second end of the fold to naturally position the limb in a preferred position without user intervention. It has a central axis behind the central axis.

[60] The use of truncated cone-shaped folds with a first end that is eccentric with respect to the second end facilitates the closure due to the irregular shape of the user's anatomy. And it has been found that it allows for an intuitive fit. In particular, the described shape of the seal can close a small depression or groove in the user's anatomy, for example, which is common on the anterior surface of the lower leg where the tibia can narrowly project from the calf. ..

[61] The surface of the seal is a friction-enhancing material or smooth to improve the seal to the limb and facilitate rewinding and fixation of the seal around the opening of the pressure chamber during limb insertion. A surface can be provided. The second end of the sealing portion may further be provided with a protrusion for fixing the sealing portion in the open position or the winding position.

[62] The seal preferably has a length sufficient to engage the patient's limbs over a predetermined distance to ensure good seal and prevent the formation of pressure points. The outer surface of the sealing portion may be marked for trimming or cutting in order to adjust the length of the sealing portion or the diameter of the first end of the sealing portion.

[63] Since the sealing portion is configured to firmly grip the user's limbs, the outer surface of the sealing portion is a pull tab to facilitate the user's intuitive gripping and opening of the sealing portion. Can be provided.

[64] The sealing portion may comprise an elastic material and may be configured to have a variable thickness such that the second end of the folded portion is thicker than the first end. The thicker material at the second end allows for a more secure attachment to the pressure chamber, while the thinner material at the first end makes it easier for the user to open and rewind the seal. To. The sealing part can be manufactured by injection molding, where the injection point is the circumference of the second end of the folded part to avoid a single injection point that is prone to tearing after repeated use and an unpleasant weld seam. To be equipped.

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

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

[67] In other embodiments, the stabilizing structure may be separate from the pressure chamber, adjusting to the position of the pressure chamber and keeping the pressure chamber in place with a bean bag, hanger, or inflatable pillow, etc. Can be configured.

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

[69] The use of positioning mechanisms has been shown to increase the usefulness of pressure therapy equipment by facilitating the consistent and correct positioning of the limbs within the pressure chamber, and surprisingly, the shadow. Achieve additional massage effects during the pressure cycle, pushing blood out of the vascular bed under the foot. The positioning mechanism may be configured to contact the user's limbs only at specific points, such as the arch of the foot, to avoid wounds commonly found on the heel or footpad of the foot.

[70] In an alternative embodiment, the positioning mechanism may be configured to extend from the pressure chamber in a releasable configuration so that when contacted by the user's limb, the mechanism separates from the limb. Is moved to prevent the mechanism from contacting the limb after the limb has been positioned. The use of an openable positioning mechanism allows for consistent placement of the limbs while leaving the limbs freely hanging in the pressure chamber. In another embodiment, the positioning mechanism can be folded in response to negative pressure.

[71] Such a free hanging configuration may be advantageous in the presence of a wound at the bottom of the user's limb.

[72] According to one 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 the first period of non-atmospheric pressure is followed by a second period of non-atmospheric or atmospheric pressure. Additional embodiments and descriptions are provided in US Pat. No. 7,833,179 issued on November 16, 2010, US Pat. No. 7,833,180, issued on November 16, 2010, 2011. US Pat. No. 8,021,314 issued on September 20, US Pat. No. 8,361,001 issued on January 29, 2013, US Patent No. 8,361,001 issued on September 2, 2014. It is provided in No. 8,821,422 and US Pat. No. 8,657,864 issued on February 25, 2014.

[73] The pump unit may include a first valve system configured to operate as a one-way valve with a safety release function. The first valve system may include a chamfer washer to close the pipe or line. The chamfer washer may be provided with a through hole and may be placed against an elastic coating that fits the tube and is configured to close the through hole in the chamfer washer.

[74] Chamfered washers and elastic coatings define a central opening and provide communication between the pressure region side of the pipe or valve and the atmosphere or pump side. A sealing unit, such as a sphere, is configured to fit the dimensions of the central opening and seal the closed first valve system. The chamfered edges and elastic coating allow the sealing unit to be designed with high tolerances while still preventing leakage.

[75] At a given pressure level, the sealing unit may be moved 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 dimensions of the central opening calibrate the first valve system to a predetermined pressure range to prevent misuse or damage due to high pressure.

[76] The chamfer washer may define additional openings that are not defined by the elastic coating. In this configuration, the elastic coating acts as a one-way valve, opening additional openings or through holes to allow air to be removed from the pressure region side during pump operation, and the pump is used. When not, seal the negative pressure on the pressure area side. The additional openings are closed by an elastic coating under negative pressure and an opening under positive overpressure.

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

[78] In one embodiment, the first valve system is configured to displace the sealing unit at a given time or in response to a given event in order to control the application and release of non-atmospheric pressure. It may include a lever arm. In one embodiment, the lever arm displaces the sealing unit during operation of the pump unit so that the pump unit can remove air from the pressure region side, and during non-operation of the pump unit so that the opening is sealed. Can be adapted to release the sealing 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 is slowly adjusted back to atmospheric pressure levels when the pump unit is not operating. The use of leak valves helps prevent misuse of unsafe pressure levels and / or pressure levels maintained over unsafe time periods.

[80] Similar leak holes may be provided in the inflatable pad and covered with tape to seal the hole, thereby allowing the user to tape the inflatable pad if the valve fails. The inflatable pad can be removed and emptied.

[81] The pump unit may include a piston configured to generate non-atmospheric pressure. The piston may include elastic extensions or blades to increase design tolerances and reduce friction between the piston and cylinder. The blades may also be constructed with predetermined elasticity so that the blades fold inward in response to a predetermined pressure and prevent the occurrence of unsafe pressure levels.

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

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

[84] The pressure therapy device may be provided as a kit that includes a combination of pressure chamber, inflatable pad, pump unit, control unit and / or seal. The pressure therapy device can be configured by the technician or user to suit the needs and anatomy of the particular user, depending on the advantageous configuration of each component.

[85] Methods using pressure therapy equipment may include inserting the user's limb through the opening of the pressure chamber such that the pressure chamber, seal, and inflatable pad surround the limb. The inflatable pad can be in a contracted state and the seal can be in a retracted or wrapped position so that upon insertion of the limb 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 so that the pressure chamber is in an upright position on the flat surface of the lower surface when the limb is inserted. The limb can then contact the positioning mechanism within the pressure chamber, which can rotate to be located on the flat surface of the lower surface.

[87] The seal can then be extended or deployed to fit the user's limb and cover the opening of the pressure chamber and the inflatable pad within it.

[88] During operation of the pump unit, the pump unit draws air from the pressure chamber through conduits in the pressure chamber. In response to negative pressure, the inflatable pad expands through the valve, away from the edges and inner surface of the pressure chamber and anchoring the limb into the opening of the pressure chamber. Negative pressure also pulls the seal against the user's limbs, separating the interior of the pressure chamber from atmospheric pressure.

[89] Negative pressure is applied pulsatilely to the limb, but the inflatable pad remains inflated, providing a good massage effect on the limb during the period of overpressure.

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

[92] FIG. 1 shows a perspective view of a pressure therapy device. [93] FIG. 2 shows a perspective view of a pressure chamber with and without an inflatable pad. [94] FIG. 3 shows a perspective view of the pressure therapy device in which the seal is in the extended and retracted positions. [95] FIG. 4 shows a perspective view of a pressure therapy device configured to have an adjustment piece and a method of attaching and detaching. [96] FIG. 5 shows a perspective view of the adjustment of the seal around the patient's limb. [97] FIG. 6 shows a perspective view of a pressure therapy device having a stabilized structure. [98] FIG. 7 is a plan view of the 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 stabilized structure. [102] FIG. 11 shows a perspective view of the sealed portion for use with the pressure therapy device according to the invention. [103] FIG. 12 shows a side perspective view of the sealed portion of FIG. [104] FIG. 13 shows a top perspective view of the sealed portion according to FIG. [105] FIG. 14 shows an enlarged perspective view of at least one second locking element above the interior of the pressure chamber. [106] FIG. 15 shows a plan view of an example of a hole corresponding to at least one second locking element. [107] FIG. 16 shows a plan view of a positioning mechanism having a foldable configuration. [108] FIG. 17 shows a perspective view of a pressure chamber having a positioning mechanism. [109] FIG. 18 shows 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 blades. [111] FIG. 20 shows a parallel plan view of the valves in open and closed configurations. [112] FIG. 21 shows a side perspective view of a pressure chamber having a lever actuating valve mechanism. [113] FIG. 22 shows a side perspective view of a pressure chamber having a timer valve mechanism. [114] FIG. 23 is a parallel detailed view of the timer valve mechanism including the operating spring and rotary damper. [115] FIG. 24 is a perspective view of a pressure chamber system containing a plurality of components. [116] FIG. 25 is a bottom perspective view of a pressure chamber having different angle portions on the rear and front sides. [117] FIG. 26 is a side view of the pressure chamber moved from an upright position to a lower surface by the user's limb. [118] FIG. 27 is a perspective view of the inflatable pad. [119] FIG. 28 is a perspective view of the positioning mechanism.

A better understanding of the different embodiments of the present disclosure can be obtained from the following description in which similar reference characters are read with accompanying drawings pointing to similar elements.

[122] A number of pressure therapy device embodiments and components for use with them are described herein with particular focus on devices and components intended for the limbs. The limb can be any part of the human or animal body that can be easily inserted into the device. The limbs can include two or more of the arms or legs, parts of the arms or legs (eg, forearms, hands, lower legs, or feet), or such parts of the body. Although pressure therapy devices are described in the context of preferred embodiments intended for the lower legs and feet, many features described herein are pressure therapy devices and components that secure other limbs and body parts. Can be extended to.

[123] Embodiments of pressure therapy equipment and components for use with it can be sized to accommodate human joints and appendages of different types, shapes, and sizes. In addition, embodiments can be modified to orient the major forces exerted by the pressure system of embodiments in any desired position. The embodiment can be further modified to secure the device on the limb in any desired position.

[124] For purposes of explanation, each pressure therapy device embodiment or component thereof described herein may be divided into sections indicated by common anatomical terms of the human body. Although such anatomical terms are provided to distinguish the various elements of the embodiment of the instrument from each other, they should not be considered to limit the scope of the present disclosure.

[125] Each of these terms is used, for example, with respect to the human leg, which is divided into similar sections using the 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" can be used in combination with "proximal" and "distal" to imply changes in "proximal" and "distal" positions.

[126] Embodiments of pressure therapy equipment can also be considered within the "anterior" and "posterior" sections of the anterior-posterior surface. The anterior-posterior plane generally corresponds to the coronal or frontal plane of the human limb located along the central longitudinal axis of the body. Thus, the posterior side or element is behind this anterior-rear surface, whereas the anterior side or element is in front of the anterior-rear surface.

[127] The terms "inside" or "inside" are commonly used herein to distinguish between sides of a device that may be particularly adjacent to the limbs of the user of the device. Conversely, the terms "outside" or "outside" are used to refer to the side of the device opposite to the inside.

[128] According to embodiments of the present disclosure, pressure therapy devices with advantageous configurations of pressure chambers, seals, inflatable pads, positioning mechanisms, pump units, and similar are disclosed. The advantages of these embodiments are that the pressure therapy device is easy to move on the limbs, easy and safe to operate even by an untrained user, and the efficacy of pressure therapy operated by the device. It 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. The anterior surface 116 may be provided with a first locking element 126, the first end 114 defining an opening 120 to a receiving area 122 inside the pressure chamber 110 that extends distally into the pressure area 124. To be done.

[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. The embodiment of the pressure therapy device 100 is not limited to a specific position of the conduit 188 as long as the conduit 188 communicates with the pressure region 124.

[131] The pump unit 190 can be any suitable device for generating non-atmospheric pressure within the pressure region 124, such as a vacuum pump. In a preferred embodiment, the pump unit 190 has additional safety and efficiency, 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. Functions can be provided.

[132] The inflatable pad 140 is fixed to the opening 120 of the pressure chamber 110 and extends through the opening 120 to the receiving area 122. The inflatable pad 140 is secured to the pressure chamber 110 by at least one second locking element 136, as shown in FIGS. 2 and 14. At least one second locking element 136 may be provided inside or above the pressure chamber 110 and is the outer surface of the pressure chamber 110 before the inflatable pad 140 extends through the opening 120 to the receiving area 122. A hook or extension is provided to pass through the corresponding hole in the inflatable pad 140 so that it may include an extension that overlaps 116, 118. The at least one second locking element 136 may include a wide top or knob having a total height of 1.5 mm and a height of 0.5 mm.

[133] A portion of the inflatable pad 140 with holes corresponding to at least one second locking element 136 is better anchored by the pressure chamber 110 to provide an audible confirmation or snap indicating proper mounting. In addition, it can be reinforced by increasing the material thickness. The increase in material thickness may be provided by a plastic or fabric band, such as a hosta fan band 240, that is fixed to or incorporated into the inflatable pad 140. In one embodiment, a portion of the 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 reinforced surface. The inflatable pad 140 can be made of a single mold or two welds to reduce the presence of seams that can create or leave pressure points on the user's limbs. The inflatable pad 140 may be provided with multiple chambers such that a portion of the inflatable pad 140 inflates separately around the user's limb.

[135] In one embodiment, the inflatable pad 140 may be formed from an inner and outer sheet, such as a TPU sheet, each of which forms a cylinder. The edges of those sheets are then welded together to form an air chamber therein. As illustrated in FIG. 27, the band 240 and knob 242 can also be incorporated or attached onto it. The band 240 and knob 242 allow the user to secure the inflatable pad 140 to the pressure chamber 110 only in the correct configuration and remove the inflatable pad 140 for cleaning or replacement.

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

[137] The inflatable pad 140 has a larger distal extension along the posterior side than along the anterior side of the user's limb because the wound is often more prevalent on the anterior side of the limb. Can be configured as The reduction of the distal extension on the anterior side relative to the posterior side also allows the user to adjust the limbs during treatment, increasing user comfort. The distal extension preferably has the distal portion of the limb in contact with the inflatable pad, as the wound is often more prevalent in the distal portion of the limb (eg, heel and ball of the foot). Restricted not to. This arrangement allows the inflatable pad 140 to effectively guide and support the user's limbs without exerting excessive pressure on sensitive or vulnerable areas.

[138] In one embodiment, the inflatable pad 140 may provide additional support and protection to the limb by extending proximally beyond the pressure chamber 110 up to 20 mm. The inflatable pad 140 has the distal extension of the inflatable pad 140 anterior to the posterior side in order to better grip the posterior side of the limb while exposing more of the limb to pressure within the pressure area 124. It can be configured to have a variable length so that it is shorter in. The inflatable pad 140 may also be provided with a piece of friction material for better gripping of the limb.

[139] The sealing portion 150 is fixed to the pressure chamber 110, surrounds the opening 120, and extends proximally beyond the pressure chamber 110. The seal 150 may be secured by at least one second locking element 136, or by friction such as friction against the limbs. The sealing portion 150 may be provided with a narrow opening 155 (shown in FIG. 12) to assist in fixing and positioning the sealing portion 150. The sealing portion 150 may be provided with an elastic material having enhanced frictional properties so that the sealing portion 150 fits tightly around the user's limb.

[140] The sealing portion 150 may comprise a hot pressed silicone, TPE, or TBE having a thickness of about 1-2 mm. The sealing portion 150 may be composed of a material having a hardness in the range of 0 to 15 shore A, more preferably about 5 shore A, whereby the material is of the user's limb without leaving an indentation or mark. It adheres firmly to the surroundings.

[141] As shown in FIGS. 3 and 11, the sealing portion 150 may have a truncated cone shape that includes a proximal end 152 and a distal end 154. The proximal end 152 may have a central axis that is eccentric to the central axis of the distal end 154 so that the limb is positioned by the posterior portion P of the opening 120, as shown in FIG. ..

[142] Once secured around the user's limb, the pull tab 157 is set to the distal length of the seal 150 to allow the user to grip and open the seal 150 around the limb. It can be configured to extend along. The proximal end 152 of the seal 150 can be rewound distally to widen the opening of the seal 150 for limb placement or removal. The protrusion 156 may be positioned on the distal end 154 to frictionally hold the seal 150 in the winding position so that the user does not have to hold the seal 150 during limb placement. This feature allows the use of the pressure therapy device 100 by an individual who does not have sufficient physical strength, dexterity, or mobility to operate 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 anchored to the pressure chamber 110 has a thickness greater than the proximal end 152, eg 1 mm, eg 2 mm. Can be. An increase in the thickness of the distal end 154 ensures a more secure attachment to the pressure chamber 110, while a decrease in the thickness of the proximal end 152 makes it easier for the user to adjust the seal 150. And positioning (such as by simply wrapping or unfolding the sealing portion 150), as well as greater comfort to the user's limbs.

[144] After placement of the limb, as shown in FIG. 5, a sealing portion 150 can be wound proximally to surround the limb and seal the pressure chamber 110 from ambient pressure. The sealing portion 150 preferably has a length sufficient to contact the limb over a predetermined length to provide a strong pressure sealing portion. In embodiments of the pressure therapy device 100, the seal 150 may be interchangeable with different sizes to fit the anatomy of different users or limbs. The sealing portion 150 may be provided with a trimming mark 158 so that the sealing portion 150 can be cut to the size of the user.

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

[146] As illustrated in FIGS. 1-2 and 6, the pressure chamber 110 may include a support surface 130 at the second end 112. The support surface 130 may include a flat bottom 132 and corners 134 and may be molded as separate parts fixed to the pressure chamber 110. The flat bottom 132 allows the pressure chamber 110 to remain stable in place so that the user can comfortably sit during the use of the pressure therapy device 100. The corners 134 may be present on the front surface 116 and the rear surface 118 so that the pressure chamber 110 can be stably positioned in the tilted position. The corners 134 can be curved so that the pressure chamber 110 can be easily rotated, or can be flat to provide stability in place.

[147] According to the embodiment of FIG. 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 an upright position, the corner to stabilize the pressure chamber in an upright position. It can be used as a heel rest for the user, allowing the limb to be inserted into the pressure chamber without rotating or flexing the limb. The user's legs and lower legs can be inserted from the sitting position by simply raising the legs and extending the knees without rotating the ankles. The limb may then come into contact with the positioning mechanism 172 within the pressure chamber 110, which may rotate to be located on a flat portion of the lower surface 130.

[149] The support surface 130 may provide modular space for accommodating one or more module components 180. In one embodiment, the modular components may be replaceable and may include vibration components, heating components, cooling components, and the like.

[150] As shown in FIG. 4, the adjustment piece 128 may engage the first locking element 126 to allow operation of the pressure chamber 110 from a distance, eg, from a seating position. .. The pressure chamber 110 can then be lifted or rotated to allow the limb to pass through the 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 is comfortably placed without contacting the wall or surface of the pressure chamber 110. Along with the rewound sealing part 150, the adjusting piece 128, the first locking element 126, and the corresponding receiving element 138, the positioning mechanism 172 allows for easy and accurate placement of the limbs within the pressure chamber 110.

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

[153] In one embodiment, the positioning mechanism 172 may have a shape corresponding to the arch of the foot, as shown in FIGS. 17, 18, and 28, for user comfort and blood flow. A slight positive pressure massage can be provided to the feet to increase the amount of pressure. In one example, the inside and outside of the positioning mechanism may have different heights and angles to more comfortably secure the user's limbs in a preferred position. The positioning mechanism 172 may be provided with a cavity, for example, to accommodate the flexibility of the positioning mechanism under the limb and / or to receive the moisture removing element 174. The moisture removing element 174 may include, for example, a silica packet.

[154] In one embodiment, the positioning mechanism 172 may also provide a small amount of pressure during the negative pressure cycle to push blood from the vascular bed under the foot towards the heart. During the oscillating pressure cycle, a slight massage effect will be experienced under the feet.

[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 the ulcer is often located. obtain. Any residual suction of the limb not compensated by the inflatable pad 140 only bends the foot upwards (toes upwards) and the heel moves slightly downwards without touching the bottom of the pressure chamber 110. Will.

[156] To provide the described massage effect without allowing the limbs to contact the bottom of the pressure chamber 110, the positioning mechanism 170 may have, for example, a height of 7-10 cm. , May have a slightly elastic arch. The positioning mechanism is strong enough to prevent the user's limbs from folding the positioning mechanism and contacting the pressure chamber, while increasing the massage effect on the limbs to provide a comfortable placement. It may be equipped with polyurethane or other slightly elastic material which 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 ensures that the positioning mechanism 172 is folded or retracted after contact with the limb to ensure that the limb is freely positioned within the chamber, as shown in FIG. , Can be storable. In another embodiment, the positioning mechanism 172 may be configured to provide support to the user's limbs throughout the operation of the pressure therapy device 100.

[158] Preferably, the limb can be positioned within 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 are combined to facilitate limb entry, whereby the pressure chamber 110 provides adjustment piece 128 and support until the limb contacts the positioning mechanism 172. The advantageous use of the corners 134 of the surface can be manipulated to "pass" over the user's limbs. Positioning the limb in this way allows the user to position the limb without the need for significant exertion or difficulty, and pressure therapy on a larger portion of the limb while preventing pressure points or skin damage. Make sure you are exposed to.

[159] In one example according to FIG. 4, the pressure chamber 110 may be configured to have a shape similar to a boot for receiving a foot. In contrast to regular boots, the pressure chamber 110 has streamlined features including a wide opening, a short neck, and a sloping front. The pressure chamber 110 can be advantageously passed over the user's foot without the flexion or rotation of 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. The pressure chamber 110, which is 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 the production and sealing of the pressure chamber 110. Is more complicated. It is preferred to use a pressure chamber 110 with a preferred wide opening 120 and a short receiving area 122 for inserting the limbs.

[161] The 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 placement position. The stabilizing structure 170 may support the user's limbs in the reclining position or assist the user in first positioning the limbs within the pressure chamber 110 to provide comfort during use. Preferably, the stabilizing structure 170 can be adjusted to different lengths and positions.

[162] Although shown as a single straight piece in FIGS. 6 and 10, the stabilizing structure 170 can be curved, can include multiple pieces, can be divided into fishtail configurations, and pressure chambers. It may be storable within 110 or separable from it. In one embodiment, the stabilizing structure 170 may include at least one elastic curvature extending from the pressure chamber 110 and may be adjustable to different positions or curvatures. The stabilizing structure 170 facilitates the use and positioning of the pressure therapy device 100 by the user and assists in avoiding pressure points or discomfort by helping the pressure therapy device 100 to be properly supported.

[163] As shown in FIG. 24, the pressure chamber 110 may be provided with a stabilizing structure 170, a positioning mechanism 172, and an adjusting piece 128.

[164] As shown in FIG. 1, the pressure chamber 110 is configured such that the front side 116 and the rear side 118 of the pressure chamber 110 extend at a predetermined angle to provide a wide opening 120. Will be done. The anterior side 116 of the pressure chamber 110 may be configured to be largely straight to facilitate the limb through the opening 120 and the receiving space without bending or rotating the limb. In certain embodiments, the posterior 118 of the pressure chamber 110 may extend beyond the extension of the anterior 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. The embodiment of the device is not limited to a particular location of the conduit as long as the conduit 188 communicates with the pressure region 124.

[166] As shown in FIGS. 7 and 19, the piston 200 of the pump unit 190 may include blades 202 for contacting the cylinder 204. As the piston 200 moves within the cylinder 204, non-atmospheric pressure is generated within the pressure chamber 110. The vane 202 reduces the friction between the piston 200 and the cylinder 204 so that the resistance of the cylinder 204 to the movement of the piston 200 is reduced, thereby moving the piston 200 to generate non-atmospheric pressure. Reduce the mechanical requirements to make it.

[167] Since the piston 200 is not in direct contact with the cylinder 204, design tolerances are increased and the piston 200 and / or the cylinder removes the part from the mold rather than a "perfect" cylinder shape. Can be manufactured by injection molding, which requires a slightly conical shape to enable. The sides of the molded part can have a tilt angle of 0.2 degrees, forming a slightly conical shape.

[168] Conventional methods for making the described wing 202-less piston 200 typically require more precise components and more expensive materials such as metal. The use of injection molded parts according to the present disclosure allows the piston 200 and / or cylinder 204 to be produced as a single injection molded part, respectively, resulting in a reduction in material cost and accuracy required in manufacturing. This is especially advantageous for the cost of producing components that require precise fit, and the use of blades 202 increases tolerances for components of different sizes, which increases the cost of the manufacturing process and It simplifies complexity and reduces the cost of piston 200 and cylinder 204.

[169] In one embodiment, the blade 202 may include an elastic material to be adjusted to the dimensions of the piston 200 and cylinder 204. The use of elastic blades 202 allows the piston 200 to be adjusted to various dimensions of the cylinder 204. The adjustable properties of the piston 200 and elastic blades 202 allow the manufacture of low cost cylinders 204, in particular molded cylinders in which the first end of the cylinder can have a diameter larger 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 elastic blade portion 202 is configured to have a sufficient length and elasticity to seal the cylinder 204 along its entire length.

[170] With reference to FIG. 8, a first valve system 210 for opening and closing the communication between the pressure region 124 and the ambient atmospheric pressure is illustrated. The first valve system 210 may include a pressure region 124 and an enclosed passage 212 communicating with ambient atmospheric pressure. As shown, the passage 212 may include an elastic coating 216 on the ambient atmospheric pressure side and a chamfer washer 214 on the pressure region side, and both the elastic coating 216 and the chamfer washer 214 are elastic in the chamfer washer 214. A central opening 218 wider than the covering 216 is defined. The sealing unit 220 is arranged in the passage 212 on the pressure region side of the chamfer washer 214.

[171] According to one embodiment, the sealing unit 220 may include a sphere having dimensions configured to close the central opening 218 upon contact with the chamfer washer 214 and the elastic coating 216. Since the elastic coating portion 216 comes into contact with the sealing unit 220, the design tolerance of the sealing unit 220 is increased and the sealing of the central opening 218 is improved.

[172] When generating negative pressure within the pressure region 124, the sealing unit 220 lifts the sealing unit 220 from the central opening 218 to allow communication between the pressure region 124 and the ambient atmospheric pressure. Keep the central opening 218 closed until you reach. The pressure region 124 may be configured to have maximum safety pressure by adjusting the mass of the sealing unit 220, the elasticity of the elastic coating 216, and the dimensions of the central opening 218. In a preferred embodiment, the sealing unit 220 is removed from the central opening 218 at a pressure of 60-150 mmHg, more specifically 60-75 mmHg.

[173] The chamfer washer 214 may include an additional opening 215 located on the side of the chamfer washer 214 to open the elastic coating 216 in response to overpressure. The first valve system 210 operates as a safety valve.

[174] The elastic coating 216 may be pre-stretched and secured in the passage 212 by the chamfer washers 214 and the walls of the passage 212. As illustrated in FIG. 8, the elastic coating 216 is fixed in place and cannot move or be pulled out 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 given time or in response to a given pressure. .. When the lever arm 222 displaces the sealing unit 220, the pressure chamber 110 communicates with the ambient pressure and the internal pressure of the pressure chamber can be adjusted to the ambient pressure.

[176] A preferred method of use of the pressure therapy device 100 is pressure therapy on the user's limbs. Pressure therapy can include the application of pulsating pressure, or the repeated alternating introduction of two or more different pressures over a continuous period of time. In one example, the pulsating pressure can be provided to alternate between the introduction of the applied pressure and the release of the applied pressure to return it to near atmospheric pressure. The applied pressure can be positive or negative. In embodiments that use negative pressure, the period during which negative pressure is introduced and present is the negative pressure period. Similarly, in a system that utilizes positive pressure, the period during which positive pressure is introduced and exists is the positive pressure period. In either case, the period during which the applied pressure is released and the atmospheric pressure is returned and exists is the atmospheric pressure period.

[177] The embodiments discussed herein are discussed with reference to the applied negative pressure. Generally, negative pressure systems can be easily replaced by positive pressure systems by reversing the operation of 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 to positive pressure systems as well, unless otherwise noted. In such cases, the term "negative pressure" as used herein should be replaced with the term "positive pressure" and the pressure value should be replaced as well. This disclosure should not be construed as excluding devices and methods that use positive pressure rather than negative pressure.

[178] In some embodiments, a plurality of consecutive alternating negative and atmospheric pressure periods are applied to the limbs within the chamber without removing the limbs from the pressure chamber. Negative and atmospheric pressure periods can be the same period or different durations. In some embodiments, the negative and atmospheric pressure periods follow a known method as described in Co-owned U.S. Patent Application Publication No. 2005/0027218 published February 3, 2005. Can be selected.

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

[180] The pressure applied in the pressure chamber can be fixed or selected during use. Embodiments of the devices and methods according to the present disclosure provide 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 at least −80 mmHg (-10.7 kPa), preferably more negative pressure. In some embodiments, the negative pressure can be less than or equal to −60 mmHg (−8.0 kPa). Some embodiments utilize a negative pressure of about −40 mmHg (−5.3 kPa). Preferred negative pressures have been selected to reduce the complications that may result from applying higher negative pressures. In some embodiments, negative pressure has been selected to promote local vasodilation on the surface of the limbs while minimizing the risk of possible complications. Pulsating negative pressure has been found to promote blood flow, with pulsating negative pressure of 0-40 mmHg (0-5.3 kPa) preferably generated in the pressure chamber.

[181] According to one embodiment of the equipment of FIGS. 20 and 27, the inflatable pad 140 is configured to have a valve 192, preferably a one-way or check valve, to provide communication with ambient atmospheric pressure. Will be done. The valve 192 may be positioned so as to surround an opening in the inflatable pad 140 and extend through the side surface of the pressure chamber 110 in the fixation knob 242 which extends through the opening in the pressure chamber 110.

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

[183] The lever arm 222 may be positioned to displace the sealing unit 220 during the atmospheric pressure period and retract it during the negative pressure period. 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, whereby the torque of the motor is actuated for 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 the motor is used, and the sealing unit 220 is displaced only when the motor is not in use.

[184] At the end of the negative pressure period and during the atmospheric pressure period in the pressure chamber 110, the inflatable pad 140 may provide overpressure to the user's limbs. The overpressure results from varying pressures in the pressure chamber 110 where the inflatable pad 140 cannot be adjusted due to the closure of the valve 192. Overpressure on the user's limbs can cause the application of a positive pressure of about 10 mmHg to the user's limbs during the period of atmospheric pressure, further increasing blood flow through the user's limbs by direct mechanical force. ..

[185] The inflatable pad 140 may be constructed of a thicker or thinner material to adjust and control the magnitude of the overpressure applied to the limb. The inflatable pad 140 may have a variable thickness in order to distribute the pressure or overpressure unevenly to the limbs. Areas of thicker thickness can be arranged to contact areas that require less pressure or compression, while areas of thinner thickness contact areas that require more pressure. Can be arranged as such. The thickness can also be arranged based on the required heat transfer properties or comfort needs.

[186] When used, the inflatable pad 140 is inflated during the negative pressure period to secure the user's limbs within the pressure chamber 110. To allow the user to remove the limb after use, the inflatable pad 140 is adapted to contract to release the pressure generated during the negative pressure period of the pressure therapy device 100.

[187] To contract the inflatable pad 140 and expand the opening 120 of the pressure chamber 110 for insertion or removal of the user's limb, the valve 192 is a lever actuated valve 194, timer valve 196, or manually. A working valve (not shown) may be provided. According to FIG. 21, the lever actuating valve 194 may be provided on the outside of the pressure chamber 110 such that the sealing portion 150 at the unwinding position actuates the lever to open the valve 192. When the seal 150 is wrapped around the user's limb, the valve 192 returns to the closed position and can be inflated in response to negative pressure. According to FIG. 22, the timer valve 196 may be provided above the outside of the pressure chamber 110 so that the user can activate the valve by pressing the switch 198.

[188] As shown in FIG. 23, the switch 198 activates the valve 192 in the depressed position, but the spring 206 and so that the switch 198 slowly returns to its original position and closes the valve 192. It is connected to the rotary damper 208. The spring 206 and the rotary damper 208 may be configured to actuate the valve 192 over a predetermined amount of time such that the inflatable pad 140 is contracted for a predetermined amount of time to remove the user's limb. it can. The manually actuated valve may be provided with a button that the user can press to actuate the valve 192. The valve remains open for as long as the user presses the button. For example, in an embodiment having a three-way valve, the valve 192 can also be connected to the pump unit 190 to contract the inflatable pad 140 in a rapid manner.

[189] By providing a medical pressure therapy device according to an embodiment of the present disclosure, it is difficult to customize for an individual user, pressure therapy techniques are limited, and dexterity or physical strength is limited. Difficult to wear for a person, uncomfortable due to contact between pressure points and pressure chambers and wounds or rashes on the user's limbs, accumulation of unhealthy levels or duration of non-atmospheric pressure The problem of pressure therapy equipment that is dangerous due to is addressed. The pressure therapy device of the present disclosure advantageously allows the user to intuitively and accurately wear the device without the help of a clinician. The device adapts to the user's dimensions by the action of the seal and the inflatable pad, preventing the device from contacting the wound on the surface of the user's limb. The device also has a unique valve arrangement that provides a favorable distribution of negative pressure around the limbs and an intermittent massage effect, while automatically reducing harmful pressure levels or durations.

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

[191] In one such study, different pressure levels on the user's limbs by using the pressure therapy equipment of the present disclosure to treat a sample group of 16 individuals suffering from peripheral arterial disease. The effect of was analyzed. Over 90% of the samples in the study suffered from mild lameness and were classified as Stage II of the Fontaine stage of chronic limb ischemia.

[192] A paired 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 made, as shown in Table I below. And a statistically significant increase in Doppler flux was demonstrated.

[193] As demonstrated, embodiments of pressure therapy devices that utilize negative pressure of approximately -40 mmHg (-5.3 kPa) provide a significant improvement in blood flow through the limbs of patients suffering from peripheral arterial disease. It can be shown and thereby improve healing.

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

[195] Initial data from the study show that chronic wounds tend to worsen when revascularization options are not available, with 5/7 of the original wounds in the standard care group averaging only 275% (SD 514%). It has been shown to increase in size and develop two new wounds. Wound healing was observed in 6/9 wounds present at the start of treatment when the pressure therapy equipment of the present disclosure was used, with an average reduction in wound size of 19% (SD 78%).

[196] Along with changes in wound size, there were also changes in wound care and management. The number of dressings replaced to manage the wound increased on average from 1.67 to 3.67 in the control group, whereas in the group treated with the pressure therapy device of the present disclosure. A decrease was observed from 2.75 times per week to 1.75 times. This is a pressure of the present disclosure that goes beyond the prior art method, as each wound dressing requires both a physical cost per dressing and a professional vascular nurse or podiatrist to assist. Show the potential cost-saving benefits of therapeutic devices.

[197] Foot pain was recorded for participants on a visual analog scale where 0 represents no pain and 100 represents the worst possible pain. Podalgia 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 devices of the present disclosure. Pain management with medication was also shown to be different between the two groups, with a reduction in opioid analgesics in the treated group compared to the control group.

[198] The above case studies underscore the benefits of treatment using the pressure therapy devices of the present disclosure, including increased wound healing, reduced treatment costs, reduced pain, and reduced need for opioid use. doing. The prior art does not appear to have achieved similar benefits.

[199] As is readily apparent from the discussion above, the size, number, composition, and location of medical pressure therapy equipment and its components are custom-made by many different users with different sized joints and body parts. And it is understood that it can be adjusted to benefit from this design without design. It is also understood that the arrangement of inflatable pads, seals, positioning mechanisms, and other components can be replaced with those shown to favor users of different dimensions and medical conditions.

Claims (36)

Pressure therapy device (100)
A pressure chamber (110) having a first end (114) and a second end (112) and the first end (114) define an opening (120).
An inflatable pad (140), including a valve (192), located in the opening (120) and communicating with ambient pressure.
A sealing portion (150) fixed to the first end (114) of the pressure chamber (110) for sealing the opening (120).
The inflatable pad (140) comprises a pump unit (190) connected to the pressure chamber (110) and configured to generate negative pressure within the pressure chamber (110). In response to the negative pressure generated in the pressure chamber by (190), the opening (120) is configured to narrow and inflate and to immobilize around the user's limbs. Pressure therapy device (100). The pressure therapy device (100) according to claim 1, wherein the inflatable pad (140) is configured to expand due to overpressure when the negative pressure generated by the pump unit (190) is completed. ). The inflatable pad (140) includes at least a front air chamber and a rear air chamber, wherein the rear air chamber has a length larger than the front air chamber of the inflatable pad (140), claim 1 or 2. The pressure therapy device (100) according to. The pump unit (190) includes a first valve system (210) including a chamfer washer (214) and an elastic coating (216) defining a central opening (218) in the passage (212) and is sealed. The pressure therapy device according to any one of claims 1 to 3, wherein the unit (220) is positioned on the chamfer washer (214) in order to close the central opening (218). 100). The sealed portion (150) includes a truncated cone-shaped folded portion having a first end portion (152) and a second end portion (154), and the first end portion (152) is the second end portion (152). The pressure therapy device (100) according to any one of claims 1 to 4, which has a central axis that is eccentric with respect to the central axis of the end portion (154). The pump unit (190) includes a piston (200) and a cylinder (204), the piston (200) comprising blades (202) extending from the piston (200) to the cylinder (204). The pressure therapy device (100) according to any one of claims 1 to 5. The pressure therapy device according to any one of claims 1 to 6, wherein the outer surface of the pressure chamber (110) is provided with a first locking element (126) for fixing to the adjusting piece (128). (100). The second end (112) of the pressure chamber is provided with a support surface (130) having a flat portion (132) and a corner portion (134), according to any one of claims 1 to 7. Pressure therapy device (100). The pressure therapy device (100) according to claim 8, wherein the inside of the support surface (130) is provided with a positioning mechanism (172) for receiving a foot among the limbs. The pressure therapy device (100) according to claim 9, wherein the positioning mechanism (172) has a narrow arch shape corresponding to the arch of the foot. The first end (114) of the pressure chamber (110) is on the outer surface of the pressure chamber (110) at least one second locking element (140) for fixing to the inflatable pad (140). The pressure therapy device (100) according to any one of claims 1 to 10, wherein 136) is provided. The pressure according to any one of claims 1 to 11, wherein the pressure chamber (110) is provided with an adjustable stabilizing structure (170) extending from the second end (112). Therapeutic device (100). The second end (112) of the pressure chamber (110) comprises a support surface (130) having a modular space configured to accommodate a plurality of modular components (180), claims 1-12. The pressure therapy device (100) according to any one of the items. The pressure therapy device (100) according to claim 13, wherein the plurality of module components (180) include a heating unit, a cooling unit, a vibration unit, and / or an electrical stimulation unit. The pressure therapy device (100) according to any one of claims 1 to 14, wherein the pressure chamber is provided with a conduit (188) communicating with the pump unit (190). The front outer surface and the rear outer surface of the pressure chamber (110) are such that the distance between the front outer surface and the rear outer surface is the height of the pressure chamber (110) and the second of the pressure chamber (110). The pressure therapy device (100) according to any one of claims 1 to 15, which forms a certain angle so as to continuously increase toward the end (112). The front outer surface is straight and is configured to extend at a constant angle from the opening (120) of the pressure chamber (110), according to any one of claims 1-16. The pressure therapy device (100) described. One of claims 1-17, wherein the inflatable pad (140) extends beyond the first end (114) of the pressure chamber (110) at a distance of 5-20 mm. The pressure therapy device (100) according to. The sealed portion (150) includes a first end portion (152) and a second end portion (154), and the second end portion (154) is in an extended configuration and the second end portion (154). The pressure therapy device (100) according to any one of claims 1 to 18, which has at least one protrusion (156) for fixing the) to the first end (152). The sealing portion (150) includes a first end portion (152) and a second end portion (154), and the second end portion (154) is the thickness of the first end portion (152). The pressure therapy device (100) according to any one of claims 1 to 19, which has a thickness larger than that of halfbeak. The pressure therapy device (100) according to any one of claims 1 to 20, wherein the sealing portion (150) comprises hot-pressed silicon, TPE or TBE. The pressure therapy device (100) according to any one of claims 1 to 21, wherein the sealed portion (150) has a thickness of 1 to 2 mm. The pressure therapy device (100) according to any one of claims 1 to 22, wherein the sealing portion (150) comprises a material having a Shore A number in the range of 0 to 15. The pressure therapy device (100) according to claim 23, wherein the sealing portion (150) comprises a material having a Shore A number of 5. The pressure therapy device (100) according to any one of claims 1 to 24, wherein the valve (192) comprises a lever (194) for opening the valve to ambient pressure. The pressure therapy device (100) according to claim 6, wherein the blade portion (202) of the piston (200) is provided with an elastic material. The pressure therapy device (100) according to claim 6, wherein the blade portion (202) of the piston (200) is configured to bend in response to a pressure of 20 to 150 mmHg. 4. The sealing unit (220) is configured to have a predetermined mass so that the sealing unit (220) is removed from the central opening (218) at a pressure of 20-150 mmHg. Pressure therapy device (100). The pressure therapy device (100) according to claim 4, wherein the sealing unit (220) includes a steel ball. The first valve system (210) is a lever arm (222) configured to displace the sealing unit (220) when the pump unit (190) is operated to generate non-atmospheric pressure. The pressure therapy device (100) according to claim 4. The pressure therapy device (100) of claim 4, wherein the chamfer washer (214) is configured to define an additional opening (215) through it. 31. The pressure therapy device (100) of claim 31, wherein the elastic coating (216) is configured as a valve over the additional opening (215). A method using a pressure therapy device (100), wherein the method is
Acquiring a pressure chamber (110) having a first end (114) and a second end (112), the first end (114) defines an opening (120). ,
An inflatable pad (140) is provided in the opening (120) of the pressure chamber (110) including a valve (192) that communicates with ambient pressure.
A sealing portion (150) fixed to the first end (114) of the pressure chamber (110) for sealing the opening (120) and enclosing the inflatable pad (140). The sealing portion (150) is provided and has 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)
A method comprising inflating the inflatable pad (140) and generating negative pressure in the pressure chamber (110) to secure the limb in the opening (120). The method is
34. The method of claim 34, further comprising releasing the negative pressure in the pressure chamber (110) and generating an overpressure in the inflatable pad (140) to massage the limb. 34. The method of claim 34, wherein the inflatable pad (140) is provided with at least two air chambers. The method is
36. The method of claim 36, further comprising activating the lever mechanism (194) of the valve to contract the inflatable pad (140).