KR20200066622A - Medical pressure treatment device and its components - Google Patents

Abstract

The pressure treatment device 100 includes a pressure chamber 110, an inflatable padding 140, a seal 150 and a positioning mechanism 172. The pressure chamber 110 has an inflatable padding 140 and an opening 120 arranged to accommodate the user's limbs. The inflatable padding 140 is expandable to surround and secure the limb at a predetermined position. To seal the pressure chamber 140 from ambient atmospheric pressure, the seal 150 covers the limbs and openings 120 that include inflatable padding 140. The pump unit 190 is provided to generate non-atmospheric pressure in the pressure chamber 110, and includes a first valve system 210 and a piston 200 equipped with a safety release function to prevent unsafe pressure levels. do.

Description

Medical pressure treatment device and its components

This disclosure relates generally to medical devices for applying pressure therapy.

Many medical conditions can be treated by controlling the application of pressure to the patient's body. Health care or emergency medical personnel can apply pulsation pressure to the patient's body by massage or the like, thereby increasing the blood flow rate in the area where the pulsation pressure is applied or in the surrounding area. This pressure treatment increases peripheral circulation and/or lymph circulation, promotes blood flow, affects redistribution and spread of blood flow, and increases blood flow to heal tissues (eg, wound healing and growth of new blood vessels) It can provide many advantages by promoting and increasing the flow of substances between blood vessels and cells by increasing diffusion.

These effects include diseases such as open wounds, chronic ulcers, burns, skin grafts, diabetic ulcers, edema, pain, inactivity, spinal cord injury, lymphedema, atherosclerosis, stroke, heart attack, or cancer. And can be employed as part of a treatment regimen for patients.

In addition, pressure treatment is sometimes employed to treat patients suffering from overheating and supercooling, such as heat stroke or hypothermia, in combination with external heating or cooling to help quickly regulate the patient's body temperature. The pulsating pressure can increase the rate at which changes in the body temperature of the patient's limbs are delivered to the patient's core, and can more effectively control the patient's deep body temperature than when the patient's limbs are heated or cooled without pressure treatment.

In other situations, it may likewise be desirable to heat or cool the patient for therapeutic purposes. This may be during chemotherapy, before, after, or during surgical procedures, for example when metabolism needs to be reduced during a stroke or cardiac arrest. In other situations, it may be advisable to preheat the patient's body prior to anesthesia to prevent or reduce hypothermia.

In the most basic form, skilled medical professionals 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 a more precise pressure level than massage, and can employ both negative and positive pressure on the limbs during treatment.

However, the use of pressure therapy devices is relatively new in clinical practice, and beyond the general application of pressure on a portion of the limb, slight improvement or progress has been identified. In order to increase blood flow, there remains a need to develop new functional parts in pressure treatment devices.

To apply pressure to a patient's body, known pressure treatment devices generally establish a controlled pressure environment, such as a pressure chamber, around the user area where the pressure is controlled. Pressure can be regulated within the closed environment of the pressure chamber by removing or adding air to the chamber.

When pulsating pressure is applied to the patient's leg, for example, a regulated pressure environment can be established around the patient's feet and from above the calf toward the thigh. This may include placing the patient's leg in a pressure chamber that isolates at least a portion of the leg from the surrounding environment.

Users who require medical pressure treatment often suffer from limited mobility and flexibility due to old age or other debilitating conditions, as mentioned above, making it difficult to properly place the patient's limbs in the pressure chamber. In addition, known pressure systems are large, difficult to adjust, and complex to operate, requiring the help of skilled medical professionals to use them safely and effectively.

When applying negative pressure to a known device, the negative pressure environment created inside the pressure chamber can cause the patient's limbs to be pulled deeper into the pressure chamber and against the device's inner edge or surface. This can create pressure points on the patient's limbs and potentially limit blood circulation through the patient's limbs, resulting in bruising, discomfort, necrosis, or other undesirable effects.

In addition, patients suffering from the symptoms listed above often have weak skin and can be damaged if not adequately protected from edge protrusions. When the patient's limb is pulled to the closed end of the pressure chamber, contact between the patient's limb and the wall of the pressure chamber can create a high-pressure contact point that can damage weak skin. This can be particularly dangerous for patients with neuropathy and/or limited skin blood flow.

In other devices, the limbs may be supported or protected by padding structures that must be custom-fitted or custom-shaped to individual users to provide sufficient support and avoid pressure points on the limbs. Individual fittings require additional time, materials and the help of skilled technicians. Alternative methods of the prior art may include configuring the pressure chamber to fit the limb or the limb, which is likewise expensive and difficult to configure.

In addition to requiring large openings to allow the insertion of legs with limited ankle mobility, it is difficult to seal the pressure chamber against the patient's limbs due to irregular changes in the user's anatomical structure. Prior art methods often require elastic sealing components in high tension conditions, which are often inconvenient, require assistance in application, cause pressure on the skin and can be difficult for the user to adjust.

From above, known negative pressure systems are not configured for use by untrained patients, and special fittings, complex components and pressure generators to ensure that appropriate levels of pressure are created and released without damaging the patient's weak limbs. May be needed. These complex systems are expensive to manufacture and expensive to use on a consumer scale.

It is feared that the difficulty in using known pressure treatment devices may result in patients not receiving the necessary treatment. It is also of concern that pressure treatment devices may be misused by ineffective and/or potentially harmful pressure levels or limb placement without the intervention of skilled technicians.

It is desirable to minimize the need for customization while increasing support for the patient's limbs and maximizing the limb's exposure to pressure treatment by providing only a few sizes to the pressure treatment device. There is a need for a medical pressure treatment device that includes a simple placement and adjustment of the pressure chamber to the limb, and includes a means of sealing and applying pressure treatment to the limb while enhancing the efficacy of the pressure treatment acting on the limb by the device. .

It is also desirable to provide a pressure treatment device that allows the device to operate simply and safely in and out of a clinical environment, and has a safety function that can be manufactured at low cost.

Likewise, there is a need for a pressure therapy device that can have more advanced functionality that performs more than simply applying negative or positive pressure to a portion of the limb.

According to the embodiments described herein, the pressure treatment device is configured to create pressure treatments for the user, particularly for the patient's limbs. The pressure treatment device enables pressure application to the limbs in a closed environment, and provides comfortable fittings, safety features, improved support of the limbs and simple placement of the limbs.

Improvements in pressure treatment devices to prior art devices and methods may include new components including pressure chambers, seals, inflatable padding, and internal positioning mechanisms to support the patient's limbs. The pressure treatment device may further be provided with a new pump unit and valve system configured to improve the safety and usefulness of the device.

Indications for pressure treatment devices include open wounds, diabetic ulcers, inactivity, spinal cord injury, lymphedema, atherosclerosis, heatstroke, hypothermia, stroke, heart attack, bone fracture, inflammation, swelling, tendinitis, muscle damage or Cancer.

Various embodiments of pressure treatment devices provide significant improvements over known pressure treatment devices in the wearing and fitting process. The wearing and fitting process can be done without measurement and can be provided in accordance with the user's anatomical structure and physical capabilities. In particular, embodiments according to the invention enable the patient to perform wearing and fitting of the device without assistance.

The pressure treatment device is further configured to be adapted to the size and shape of the individual patient without the intervention of a technician or other expert so that the device is customized for optimal fit and performance.

Embodiments of the present invention may include a pressure chamber having a streamlined function including a large opening and an angled neck to facilitate insertion of the limb without bending the joint and allow comfortable positioning of the limb during use. The bottom surface of the pressure chamber can be made of a molding material and a flat base with an inclined end can be provided.

The pressure therapy device is arranged to be adjustable by the user in a seated position by providing a means for lifting and rotating the device from a distance, and can increase the user's comfort and comfort during use as compared to known devices. The pressure treatment device can be configured to cooperate with an external support function for holding or repositioning the device in a desired position.

These functionalities reduce weight, size and volume compared to known pressure treatment devices and allow the device to be worn without requiring excessive movement or bending and rotation of the limbs.

According to one embodiment of the pressure treatment device, the pressure treatment device includes a pressure chamber having a first end and a second end, and front and rear outer surfaces. The first end defines an opening configured to widen from the receiving region to a pressure region receiving and surrounding the limb.

Often prior art devices have distinct boot shapes that narrow at the user's ankle or thigh, while embodiments of the present disclosure can include large openings and interior areas. The opening can be configured to 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 can pass without rotation or bending of the limb. This is often difficult or painful for the user. The user's foot and lower leg can be introduced through the opening and neck portion of the pressure chamber at an angle of 90° without rotation or bending of the ankle.

The front and rear outer surfaces of the pressure chamber can be formed at an angle such that the distance between the front surface and the rear surface increases along a height of the pressure chamber toward the second end of the pressure chamber at a predetermined rate. The arrangement allows the wide opening to extend to a wider area within the chamber, especially on the front surface, without sharpening the angle. .

According to one embodiment of the pressure chamber, the front surface can be configured to extend in a straight line at an angle from the neck of the opening of the pressure chamber. Advantageously, the straight surface allows the user to insert the foot and lower leg at a 90° angle without the user's toes touching the surface of the pressure chamber, which is painful or causes difficulty in wearing and removing the device. can do.

The second end of the pressure chamber is closed by a support surface, the support surface having a flat portion and an angled portion at least at the rear end. The angled and flat portions are configured to allow for angular adjustment and stable placement of the pressure chamber when the limb is inserted and the device is in operation.

When inserting or removing a limb from the pressure chamber, the angled portion can be a heel rest to stabilize the pressure chamber in an upright position. When the pressure chamber is in the upright position, the user can insert the limb without rotating or bending the limb. The user's foot and lower leg can be inserted from a seated position by simply lifting the leg and extending the knee without rotating the ankle.

When the limb is in contact with the lower surface of the pressure chamber, the pressure chamber can be rotated forward and placed on a flat surface for a stable, comfortable and consistent treatment position.

The support surface can include a friction-enhancing material, such as a rubber-like material, on the outer surface to prevent the pressure chamber from slipping during use.

In addition, the outer surface of the pressure chamber can be configured transparently so that the user can clearly see the limb when the limb is positioned, and can include an indication for proper positioning of the limb. Clearly viewing the location of the limbs is advantageous for a user with neuropathy who must be able to see the limbs moving freely because they cannot feel the pressure or touch on the limbs.

The front outer surface can include a first locking element positioned to engage the adjustment piece. The adjustment piece can extend toward the first end of the pressure chamber for manipulation by the user, and can be removably secured to the pressure chamber at a location near the opening to increase leverage. The adjustment piece may include a detachable handle, and during use, the user can improve control of the positioning of the pressure chamber.

Embodiments of the pressure treatment device may secure and position the user's limb within the pressure chamber using inflatable padding and a seal located at the first end of the pressure chamber. The first end can include a second locking element to secure the inflatable padding through the opening to the receiving area of the pressure chamber.

The second locking element can be configured to engage the receiving element on the inflatable padding such that proper positioning of the inflatable padding is clear and repeatable to the user.

The seal is configured to surround the opening of the pressure chamber and the inflatable padding, and can be configured to engage the second locking element without an additional belt.

In one embodiment, the inflatable padding engages the second locking element on the outer surface of the first end of the pressure chamber at a location and extends into the opening and receiving areas of the pressure chamber. In an alternative embodiment, the inflatable padding can engage a second locking element on the inner surface of the first end of the pressure chamber.

The inflatable padding can be retracted to allow insertion of the user's limb through the opening of the pressure chamber, and when inflated can be configured to take a shape corresponding to the user's limb. By doing so, the inflatable padding can be further adapted to expand and close the opening of the pressure chamber relative to the limb.

The inflatable padding may be provided with a valve for expansion and contraction with limited user intervention. The valve is a check valve adapted to inflate the expandable padding in response to a negative pressure in the pressure chamber by drawing air from the surrounding environment into the expandable padding, and to contract only when the valve is opened by the user or at predetermined intervals, logic It can be a turn valve or a one-way valve.

It has been surprisingly found that the use of a one-way valve with negative pressure allows for automatic expansion of the inflatable padding while the pressure treatment device is operating, and provides additional massaging effect to the user's limbs during treatment. The massaging effect occurs because the inflatable padding is closed relative to the ambient pressure so that the release of negative pressure in the pressure chamber is followed by an overpressure in the inflatable padding.

When negative pressure causes blood to enter the user's limbs, overpressure causes the inflatable padding to lightly press the user's limbs at the moment the user's limbs are released from the effects of the negative pressure in the pressure chamber, for example, at the time atmospheric pressure recovers. Let or massage. This compression or massaging effect helps accelerate blood entering the user's limbs by negative pressure and increases blood flow through the limbs.

The dual advantage of negative pressure on the limb combined with the static pressure applied by the inflatable padding is achieved by simply employing the existing dynamics between negative pressure and atmospheric pressure, i.e. the introduction of negative pressure by automatically expanding the inflatable padding. The massaging effect is achieved without the need to generate a static pressure in the pressure chamber, and allows the pressure treatment device to apply both positive and negative pressure to the limb without a complicated pumping system.

The valve of the inflatable padding is a lever operated valve, a timed valve or a manually operated valve that opens when the seal is pulled from the user's limb, so that the user can easily contract the inflatable padding to remove the limb from the pressure chamber. Can be configured.

In an alternative embodiment, the inflatable padding can be configured to communicate with a pump unit such as a three-way valve.

The thickness of the material of the inflatable padding can be configured such that greater or less pressure or overpressure is applied to the limb. When the material of the expandable padding is thicker or more elastic, the expandable padding resists expansion, while the vice versa for thin or flexible materials.

In one embodiment, the inflatable padding includes at least two air chambers so that the limbs can be properly positioned within the pressure chamber. Because the air in the padding is redistributed according to the resistance provided by the limbs, the use of inflatable padding with only one air chamber fills unevenly. If the inflatable padding includes only one air chamber, the padding may not properly position the limb, but the weight and position of the limb may cause the limb to lean against the side or back of the pressure chamber.

The inflatable padding may include seamless material, single mold material, or material having multiple welds. The inflatable padding can provide a smooth inner surface free of protrusions or concave areas that can cause discomfort, indentation or marks on the user's skin.

The inflatable padding can be made of PVC or PUR, and can have a flocked surface. PUR materials are advantageous because of the increased friction compared to PVC or flocked materials. The inflatable padding can be provided with different surface types or treatments, such as a sticky surface to better maintain the user's limbs, a smooth surface, or a fluffy surface to increase user comfort.

In some configurations, the inflatable padding may have a uniform length to better grasp the posterior portion of the limb and better support the limb on the pedestal side, eg, the back side of the leg, or a front length shorter than the posterior length Can have In addition, the inflatable padding can also extend beyond the opening of the pressure chamber in the proximal direction to better grip the limb and protect the limb from the edge of the opening of the pressure chamber.

In one embodiment, the inflatable padding may extend 5-20 mm beyond the upper edge of the pressure chamber to protect the limb from contacting the hard edge of the pressure chamber.

The seal of the pressure treatment device is configured to surround the opening of the pressure chamber and the inflatable padding of the first end of the pressure chamber, such that a portion of the user's limb is enclosed therein. The seal is configured to hold the user's limbs tightly, so that the interior of the pressure chamber can be separated from the ambient pressure.

The seal can include a truncated conical cuff or a cone made of an elastic material having first and second ends. The first end of the cuff may be adapted to engage the second locking element at the first end of the pressure chamber, and the diameter may decrease as it moves from the opening to the second end of the cuff. The second end of the cuff can be disposed eccentrically to the first end, and the central axis is behind the central axis of the first end of the cuff to naturally position the limb in a desired position without user intervention.

It has been found to be advantageous to use a truncated conical cuff with a second end eccentric to the first end to allow the seal to be easily and intuitively adjusted to the irregular shape of the user's anatomical structure. In particular, the shape of the described seal can close a small dip or groove in the user's anatomical structure, such as is commonly seen on the anterior surface of the lower thigh where the tibia can protrude from the calf, for example.

The surface of the seal can be provided with a friction-enhancing material or a smooth surface to improve sealing to the limb and to facilitate rolling back and securing the seal against the opening of the pressure chamber when inserting the limb. The first end of the seal may further be provided with a protrusion for fixing the seal in an open or rolled position.

To ensure good sealing and prevent the occurrence of pressure points, the seal is preferably of sufficient length to engage the patient's limbs at a distance. To adjust the length of the seal or the diameter of the second end of the seal, the outer surface of the seal can be provided with an indication for trimming or cutting.

As the seal is configured to grip the user's limbs tightly, the outer surface of the seal may be provided with a pull tab that facilitates intuitive gripping and opening of the seal by the user.

The seal can include an elastic material and can be configured to have a variable thickness such that the first end of the cuff is thicker than the second end. The thick material at the first end allows for a safer attachment to the pressure chamber, while the thin material at the second end facilitates opening and rollback of the seal by the user. The seal can be made by injection molding, where the injection point includes a single injection point that is prone to tear after repeated use and the circumference of the second end of the cuff to avoid uncomfortable fused saem.

Modular components can be added to certain embodiments of the medical pressure treatment device to enable the application of additional treatment options to the limbs. Examples of modular components that may be combined with a pressure treatment device may include heating or cooling units, vibration units, electrical stimulation units, and the like. The modular component enhances the efficacy of the medical pressure treatment device in treating certain conditions, including hypothermia, sunstroke, and the like, and can be disposed in a modular space on the support surface of the pressure chamber. The modular space can be configured to accommodate a plurality of replaceable modular components having different functions.

In one embodiment of the pressure treatment device, a stabilizing structure is provided outside the pressure chamber to maintain the pressure chamber in a predetermined position to facilitate the user's sitting position. The stabilizing structure can be adjustable in different lengths and can include at least one stabilizing member secured to the pressure chamber. The at least one stabilizing member can be curved or straight, and can cooperate with an adjustment mechanism provided on the pressure chamber.

In other embodiments, the stabilizing structure can be detached from the pressure chamber, adapted to the position of the pressure chamber, and configured to hold the pressure chamber in place, such as an bean bag, sling or inflatable pillow. Can be.

The pressure chamber can include a positioning mechanism inside the pressure chamber to indicate and support the proper position of the limb. The positioning mechanism can be configured to support the arch of the foot without contacting the heel and ball of the foot.

The use of a positioning device increases the usefulness of the pressure treatment device by facilitating consistent and correct positioning of the limb within the pressure chamber, surprisingly achieving additional massaging effects during the negative pressure cycle, pushing blood out of the foot vessels Appeared. The positioning mechanism can 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 pad of the foot.

In an alternative embodiment, the positioning mechanism can be configured to extend from the pressure chamber in a detachable configuration, such that when the user's limb is contacted to prevent the instrument from contacting the limb after positioning of the limb is completed. , The appliance is away from the limb. The use of a detachable positioning mechanism allows for consistent placement of the limbs, leaving the limbs freely hanging in the pressure chamber. In other embodiments, the positioning mechanism may collapse in response to negative pressure.

This free hanging configuration can be advantageous if the wound is at the bottom of the user's limb.

According to an embodiment of the pressure treatment device, the pressure chamber is connected to the pump unit to provide non-atmospheric pressure in the pressure chamber. The pump unit may provide alternating pressure such that a second period of non-atmospheric pressure or atmospheric pressure follows the first period of non-atmospheric pressure. Additional embodiments and descriptions are described in US Pat. No. 7,833,179, issued November 16, 2010; United States Patent No. 7,833,180, issued on November 16, 2010; United States Patent No. 8,021,314, issued on September 20, 2011; United States Patent No. 8,361,001, issued January 29, 2013; United States Patent No. 8,821,422, issued on September 2, 2014; And US Patent No. 8,657,864, issued on February 25, 2014.

The pump unit can include a first valve system configured to operate as a one-way valve having a safety release function. The first valve system can include a chamfered washer to close the tube or line. The chamfered washer may include a through hole, and may be disposed in an elastic covering fitted to the tube and configured to close the through hole of the chamfered washer.

The chamfered washer and elastic covering define a central opening that provides communication between the pressure zone side and the atmospheric or pump side of the tube or valve. A sealing unit such as a ball is fitted to the dimensions of the central opening and is configured to seal the closed first valve system. The sealing unit can be designed with high tolerances while preventing leakage due to the chamfered edge and elastic covering.

At a given pressure level, the seal unit moves from the central opening to allow communication with atmospheric pressure, thereby preventing the internal pressure from reaching an unsafe level. 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 and prevent misuse or injury due to high pressure.

The chamfered washer can define additional openings that are not defined by the elastic covering. In this configuration, the elastic covering acts as a one-way valve, and air is removed from the pressure region side when the pump is operating, and an additional opening or opening to allow sealing the negative pressure on the pressure region side when the pump is not operating. Open the through hole. The additional opening is closed by an elastic covering under negative pressure and an opening under positive overpressure.

The elasticity of the elastic covering can be configured to calibrate the first valve system to a predetermined pressure range. In addition, the elastic covering can be pre-stretched to prevent the cover from moving or stretching into the central opening or additional hole.

In one embodiment, the first valve system can include a lever arm configured to displace the seal unit at a predetermined time or in response to a predetermined event to control the application and release of non-atmospheric pressure. In one embodiment, the lever arm displaces the sealing unit during operation of the pump unit so that the pump unit removes air from the pressure region side, and when the pump unit is inactive, releases the sealing unit to seal the opening. It can be adapted as much as possible.

Further, the first valve system or pressure chamber may be provided with a permanent opening or a leak valve. The leak valve is configured to provide a small opening for atmospheric pressure so that when the pump unit is not in operation, the pressure in the chamber is gradually adjusted back to the atmospheric pressure level. The use of leak valves helps prevent misuse, such as unsafe pressure levels and/or pressure levels maintained during unsafe periods.

Similar leakage holes can be provided in the inflatable padding and covered with tape to seal the holes so that the user can remove the tape and empty the inflatable padding when the valve of the inflatable padding is not working.

The pump unit can include a piston configured to generate non-atmospheric pressure. The piston may include an elastic extension or wing to increase geometric tolerances and reduce friction between the piston and cylinder. The wing can be configured with a predetermined elasticity, so that it can be folded inward in response to a predetermined pressure to prevent the occurrence of an unsafe pressure level.

The pressure treatment device may include a control unit comprising a processor and a memory for operating the pump unit. The control unit may include a pressure chamber or other component, or a sensor provided at the user's limb, to monitor and record treatment results. The control unit can be programmed by the user or medical professional, and software can be provided to ensure compliance with the individual treatment regimen.

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 medical professional can access and update the information stored by the control unit.

The pressure treatment device may be provided as a kit comprising a combination of a pressure chamber, inflatable padding, pump unit, control unit and/or seal. The pressure treatment device can be configured to the needs of a particular user and the anatomical structure by a technician or user due to the advantageous configuration of each part.

A method of using a pressure treatment device may include inserting a user's limb through an opening in the pressure chamber such that the pressure chamber, seal and inflatable padding surround the limb. Upon insertion of the limb, the expandable padding can be in a retracted state so that the limb has space to pass through the opening of the pressure chamber without the limb rotating, and the seal can be in a retracted or rolled position.

The step of inserting the limb may further include rotating the position of the pressure chamber such that when the limb is inserted, the pressure chamber is in an upright position on a flat portion of the lower surface. The limb can then contact the positioning mechanism in the pressure chamber, and the pressure chamber can rotate to lie on a flat portion of the lower surface.

The seal can then be expanded or unrolled to fit the user's limbs and cover the opening of the pressure chamber and the inflatable padding therein.

In operation of the pump unit, the pump unit draws air from the pressure chamber through the conduit of the pressure chamber. In response to the negative pressure, the expandable padding extends through the valve away from the edge and inner surface of the pressure chamber and secures the limb to the opening of the pressure chamber. Similarly, the negative pressure separates the interior of the pressure chamber from atmospheric pressure by pulling the seal against the user's limb.

The negative pressure is applied to the limbs in a pulsating manner, while the inflatable padding remains inflated and gives a positive massage effect to the limbs during the overpressure period.

These and other features, aspects and advantages of the present disclosure will be better understood in conjunction with the following description, appended claims and accompanying drawings.

1 shows a perspective view of a pressure treatment device.
2 shows a perspective view of a pressure chamber with and without inflatable padding.
3 shows a perspective view of a pressure treatment device with seals in the extended and retracted positions.
4 shows a perspective view of a pressure treatment device consisting of an adjustment piece and a method of wearing and removing.
5 shows a perspective view of the seal adjustment to the patient's limbs.
6 shows a perspective view of a pressure treatment device with a stabilizing structure.
7 is a plan view of the piston of the pump unit.
8 is a plan view of the first valve system of the pump unit.
9 is a plan view of a first valve system of a pump unit with a lever arm.
10 is a perspective view of an image of a pressure treatment device with a stabilizing structure.
11 shows a perspective view of a seal used in a pressure treatment device according to the invention.
12 shows a side perspective view of the seal of FIG. 11.
13 shows a top perspective view of the seal according to FIG. 11;
14 shows an enlarged perspective view of at least one second locking element inside the pressure chamber.
15 shows a top view of an example of a hole corresponding to at least one second locking element.
16 shows a top view of a positioning mechanism having a collapsed configuration.
17 shows a perspective view of a pressure chamber with a positioning mechanism.
18 shows a side perspective view of a pressure chamber with a positioning mechanism.
19 shows an enlarged perspective view of a piston with an elastic wing.
20 shows a side-by-side top view of a valve in an open and closed configuration.
21 shows a side perspective view of a pressure chamber with a lever operated valve mechanism.
22 shows a side perspective view of a pressure chamber with a timer valve mechanism.
23 is a side-by-side detail view of a timer valve mechanism including a spring and a rotary damper in an operating state.
24 is a perspective view of a pressure chamber system including a plurality of components.
25 is a bottom perspective view of a pressure chamber with different angled portions on the rear and front sides.
26 is a side view of the pressure chamber moved from the upright position so that the user's limb is on the lower surface.
27 is a perspective view of inflatable padding.
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 read with the accompanying drawings in which the same reference numbers refer to the same elements.

A number of pressure treatment device embodiments and components for use with them are described herein, with particular emphasis on devices and components related to the limbs. The limb can be any part of the human or animal body that can be easily introduced into the device. Limbs may include one or more of the arms or legs, parts of the arms or legs (eg, forearms, hands, thighs or feet) or those parts of the body. Pressure treatment devices are described in the context of preferred embodiments of the lower leg and foot, but many of the ridges described herein can be extended to pressure treatment devices and components that secure other limbs and body parts.

The pressure treatment device embodiments and components for use with them can be sized to accommodate different types, shapes and sizes of human joints and appendages. In addition, the embodiments can be modified to counteract the main force exerted by the pressure system of the embodiments in any desired position. Embodiments can be modified to secure the device to the limb in any desired position.

For purposes of illustration, each pressure treatment device embodiment described herein or component thereof may be divided into sections indicated in general anatomical terms for the human body. These anatomical terms are provided to distinguish various elements of device embodiments from others, but should not be considered as limiting the scope of the present disclosure.

Each of these terms is used in relation to the human leg and is divided into sections, for example similar to 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 denote a stepwise change in the position of “proximal” and “distal”.

In addition, embodiments of the pressure treatment device can also be considered to be within the “front” and “rear” sections of the anterior-rear plane. The anterior-posterior plane generally corresponds to the coronal or frontal surface of a person's limb lying along the central longitudinal axis of the body. Thus, the rear side or rear element is behind this front-rear plane, and the front side or front element is before the front-rear plane.

The terms “inward” or “internal” are generally used herein to distinguish aspects of the device that may be particularly proximal to the user's limbs of the device. Conversely, the term "outward" or "outside" is used to denote the side of the device opposite the inward side.

According to embodiments of the present invention, a pressure treatment device having an advantageous configuration of a pressure chamber, seal, inflatable padding, positioning mechanism, pump unit, etc. is disclosed. The advantage of these embodiments is that the pressure treatment device is easy to maneuver on the extremities, simple and safe to operate even by an inexperienced user, and convenient to use while improving the efficacy of the pressure treatment operated by the device.

1 shows one embodiment of a pressure treatment device 100 having a pressure chamber 110 with first and second ends 112, 114 and front and rear surfaces 116, 118. The front surface 116 can be provided with a first locking element 126, the second end 114 being in a receiving area 122 inside the pressure chamber 110 that extends into the distal pressure area 124. The opening 120 is defined.

The pressure region 124 of the pressure chamber 110 can communicate with a pump unit 190 having a conduit 188 on the rear side 118 of the pressure chamber 110. Embodiments of the pressure treatment device 100 are not limited to a specific location of the conduit 188 as long as the conduit 188 communicates with the pressure region 124.

The pump unit 190 can be any suitable device for generating non-atmospheric pressure in a pressure region 124, such as a vacuum pump. In a preferred embodiment, the pump unit 190 is further added with 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, etc. Safety and efficiency functions are provided.

The inflatable padding 140 is fixed to the opening 120 of the pressure chamber 110 and extends through the opening 120 to the receiving area 122. 2 and 14, the inflatable padding 140 is secured to the pressure chamber 110 by at least one second locking element 136. The at least one second locking element 136 can be provided inside or outside the pressure chamber 110, before the expandable padding 140 extends through the opening 120 into the receiving area 122, the pressure chamber The outer surface 116, 118 of 110 and the superimposition may include hooks or protrusions for passing through corresponding holes in the inflatable padding 140, so as to include extensions. The at least one second locking element 136 may have an overall height of 1.5 mm and may include an extended top or knob with a height of 0.5 mm.

A portion of the inflatable padding 140 provided with a hole corresponding to at least one second locking element 136 is better secured to the pressure chamber 110 and provides an audible confirmation, or snap, indicating proper attachment It can be strengthened by increasing the material thickness. The increase in material thickness can be provided by a plastic or fabric band, such as a hosta plate band 240 fixed or integrated in the inflatable padding 140. In one embodiment, the portion of the inflatable padding 140 has a thickness of 0.35 mm. As illustrated by the example of FIG. 15, the hole can be configured in a shape corresponding to the second locking element 136.

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

In one embodiment, the inflatable padding 140 may be formed of inner and outer sheets, such as TPU sheets, each forming a cylinder. Subsequently, the ends of the sheets are welded together to form an air chamber therein. Further, as shown in FIG. 27, the band 240 and the knob 242 may be integrated or attached thereon. The band 240 and knob 242 allow the user to secure the inflatable padding 140 to the pressure chamber 110 only in the correct configuration and remove the inflatable padding 140 for cleaning or replacement.

In the illustrated embodiment of FIG. 1, the inflatable padding 140 is inflated to grip the user's limbs and narrow the opening 120 to a sealable dimension. The expandable padding 140 enables the use of very wide openings 120 and limbs of different sizes while still allowing effective sealing of the pressure chamber 110 without requiring excessive rotation or bending of the limb. To facilitate the placement of. The inflatable padding 140 is configured to inflate and adjust the dimensions of the opening 120 to fit the user's anatomical structure and press against the limbs.

The inflatable padding 140 may be configured to have a larger distal extension along the posterior side of the user's limb than along the anterior side because wounds are often more common on the anterior side of the limb. In addition, the reduced distal extension on the front side compared to the rear side allows the user to adjust the limbs during treatment and increases the user's comfort. It is preferred that the distal extension is restricted so that the distal portion of the limb does not contact the inflatable padding, as there are cases where the wound is more common in the distal portion of the limb (eg, the heel and ball of the foot). This arrangement allows the inflatable padding 140 to effectively guide and support the user's limbs without applying excessive pressure to sensitive or weak areas. .

In one embodiment, the inflatable padding 140 extends up to 20 mm in the proximal direction beyond the pressure chamber 110 to provide additional support and protection to the limb. The inflatable padding 140 has a variable length such that the distal extension of the inflatable padding is shorter on the front side than on the rear side to better grip the rear side of the limb while exposing the limb more to the pressure in the pressure region 124. Can be configured. In addition, the inflatable padding 140 may also be provided with a streaked friction material to better grip the limbs.

The seal 150 is fixed to the pressure chamber 110 surrounding the opening 120 and extending in the proximal direction beyond the pressure chamber 110. Seal 150 may be secured by at least one second locking element 136 or by a frictional force such as friction against a limb. The seal 150 may be provided with a narrow opening 155 (shown in FIG. 12) to help fix and position the seal 150. The seal 150 may include an elastic material with improved friction properties, such that the seal 150 is securely fitted to the user's limbs.

The seal 150 may include heat-pressed silicone, TPE or TBE having a thickness of about 1-2 mm. The seal 150 may be made of a material having a hardness within the range of 0-15 Shore A, more preferably about 5 Shore A, such that the material is securely attached to the user's limbs without leaving indentations or marks.

3 and 11, the seal 150 can have a truncated conical shape including a proximal end 152 and a distal end 154. As shown in FIG. 12, the proximal end 152 may have a central axis eccentric to the central axis of the distal end 154 such that the limb is further positioned at the rear portion P of the opening 120.

When secured to the user's limb, the pull tab 157 may be configured to extend along the distal length of the seal 150 so that the user can grip and open the seal 150 relative to the limb. The proximal end 152 of the seal 150 can be rolled back distally to widen the opening of the seal 150 for placement or removal of the limb. The protrusion 156 can be positioned at the distal end 154 so that the seal 150 in the rolled position is maintained by friction so that the user does not need to hold the seal 150 behind while placing the limb. This function enables a person who does not have sufficient force, agility, or mobility to maneuver the seal while also maneuvering the limb or pressure chamber 110 to use the pressure treatment device 100.

In one embodiment, the seal 150 has a distal end 154 secured to the pressure chamber 110 having a thickness greater than the proximal end 152, for example 2 mm greater than the proximal end 152, such as 1 mm greater. It may have a variable thickness to have a thickness. 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 is performed by the user (eg, simply rolling the seal 150). Or by unrolling) to allow easier adjustment and placement of the seal 150, and to improve comfort for the user's limbs.

As shown in FIG. 5, after placement of the limb, the seal 150 may be rolled proximally to surround the limb and seal the pressure chamber 110 from atmospheric pressure. The seal 150 is preferably of sufficient length to contact the limb over a predetermined length to provide a strong pressure seal. In one embodiment of the pressure treatment device 100, the seal 150 can be replaced with different sizes to fit the anatomical structure of another user or limb. The seal 150 is provided with a trimming mark 158 to cut the seal 150 to the user's dimensions.

In one embodiment, the inflatable padding 140 extends up to 20 mm in the proximal direction beyond the pressure chamber 110 to provide additional support and protection to the limb.

1 to 2 and 6, the pressure chamber 110 may include a support surface 130 at the second end 114. The support surface 130 can include a flat bottom portion 132 and an angled portion 134 and can be molded as separate portions secured to the pressure chamber 110. The flat bottom portion 132 allows the pressure chamber 110 to be held stable at a predetermined position so that the user can sit comfortably while using the pressure treatment device 100. The angled portion 134 can be present on the front and rear surfaces 116 and 118 so that the pressure chamber 110 can be stably positioned in an inclined position. The angled portion 134 can be bent so that the pressure chamber 110 can rotate easily, or can be flat to provide stability in a predetermined position.

According to the embodiment of Fig. 25, the rear angled portion 135 is flat, and the front angled portion 133 is curved.

26, the pressure chamber 110 may be positioned to lie in the rear angled portion 135 in an upright position so that the user can insert the limb into the pressure chamber without rotating or bending the limb, where the angle is angled. The portion can be used as a heel rest to stabilize the pressure chamber in an upright position. The user's foot and lower leg can be inserted from a seated position by simply lifting the leg and extending the knee without rotating the ankle. The limb can then contact the positioning mechanism 172 in the pressure chamber 110, and the pressure chamber 110 can rotate to lie on a flat portion of the lower surface 130.

The support surface 130 can include a modular space 180 for receiving one or more modular components. In one embodiment, the modular component can be replaceable and can include vibration components, heating components, cooling components, and the like.

As shown in FIG. 4, the adjustment piece 128 may engage the first locking element 126 to allow, for example, manipulation of the pressure chamber 110 away from a seated position. The pressure chamber 110 can then be lifted or rotated to allow passage of the limb through the opening 120 without requiring bending or rotation of the limb.

The positioning mechanism 172 can indicate to the user the correct position of the limb in the pressure chamber 110 so that the limb rests comfortably without contacting a wall or surface within the pressure chamber 110. With the rolled seal 150, the adjusting piece 128, the third locking element 162 and the corresponding receiving element 138, the positioning mechanism 172 easily and accurately positions the limb within the pressure chamber 110. Allow.

The positioning mechanism 172 is preferably located within the pressure chamber 110 to avoid contact with sensitive areas of the user's limbs. 28, the positioning mechanism 172 may be provided with a receiving element 175, such as a groove, for securing to the lower surface 130 of the pressure chamber. The lower surface 130 of the pressure chamber 110 can have a corresponding projection or locking element. In one embodiment, the positioning mechanism 172 includes a plurality of receiving elements (corresponding to a plurality of protrusions on the lower surface 130 of the pressure chamber such that the positioning mechanism is adjustable and can be secured to the pressure chamber in various positions) 175) is provided. The positioning mechanism 172 can be secured to the lower surface 130 of the pressure chamber 110.

In one embodiment, as shown in FIGS. 17, 18, and 28, the positioning mechanism 172 may have a shape corresponding to the arch of the foot, and provide a slight static pressure massage to the foot for user comfort and It can increase blood flow. In one example, the inside and outside of the positioning mechanism can have different heights and angles, and can more securely fix the user's limbs in a desired position. The positioning mechanism 172 can be provided with a hollow space for adjusting the flexibility of the positioning mechanism under the limb and/or for receiving the moisture removal element 174. The moisture removal element 174 can include, for example, a silica packet.

In one embodiment, the positioning mechanism 172 also provides some pressure during the negative pressure cycle to push blood from the blood vessels under the foot toward the heart. During the oscillating pressure cycle, a slight massaging effect appears under the feet.

The positioning mechanism 172 can be configured in a predetermined shape, such as a narrow arch with a predetermined height designed to avoid compression under the toe, forefoot and heel where ulcers are often located. Any residual suction of the limbs not compensated by the inflatable padding 140 will only cause the foot to bend upward (toe upward), and the heel will move slightly downwards without touching the bottom of the pressure chamber 110. .

In order to provide the described massaging effect without allowing the limb to contact the bottom of the pressure chamber 110, the positioning mechanism 170 may include some elastic arch, such as having a height of 7-10 cm. Can be. The positioning mechanism can include polyurethane or some other elastic material that is strong enough to prevent the user's limbs from collapsing and contacting the pressure chamber, and the massaging effect on the limbs is high and comfortable. It also has some elasticity to provide relaxation. The positioning mechanism may have a hardness of 30 to 50 shore A, more specifically 45 shore A.

As shown in FIG. 16, the positioning mechanism 172 can be retracted such that the positioning mechanism 172 collapses or withdraws to ensure that the limb is freely positioned within the chamber after contact with the limb. In other embodiments, the positioning mechanism 172 may be configured to support the user's limbs while the pressure treatment device 100 is operating.

Preferably, as shown in FIG. 6, the limb may be positioned within the pressure chamber 110 without contacting the pressure chamber 110. The wide opening 120 and the short “neck” or receiving area 122 engage to facilitate entry of the limb, so that the adjustment piece 128 and the supporting surface of the limb until the limb contacts the positioning mechanism 172. By using the angled portion 134 advantageously, the pressure chamber can be manipulated to “thread” on the user's limb. Placing the limbs in this way allows the user to position the limbs without significant effort or difficulty and ensures that various parts of the limb are exposed to pressure treatment while preventing pressure points or skin damage.

In the example according to FIG. 4, the pressure chamber 110 may be configured to have a shape similar to a boot for receiving a foot. Unlike ordinary boots, the pressure chamber 110 has a streamlined function that includes a wide opening, a short neck, and an inclined front portion. The pressure chamber 110 can be advantageously threaded on the user's foot without bending or rotating the ankle or other joint, which can be difficult or painful for the user.

The pressure chamber 110 can be configured to be assembled or closed relative to the limb. The pressure chamber 110 configured to be assembled or closed relative to the limb provides the same advantages as limited bending or rotation of the limb, but is more difficult to implement and more complicated to manufacture and seal the pressure chamber 110. It is preferred to use a pressure chamber 110 having a wide opening 120 and a short receiving area 122, which are preferred for the insertion of the limb.

The stabilizing structure 170 can extend from the pressure chamber 110 to position the pressure chamber 110 and support the limbs in a particular position, for example, a stable position. The stabilizing structure 170 can support the user's limb in a lying position to provide comfort in use, or can assist the user in initial positioning of the limb in the pressure chamber 110. Preferably, the stabilizing structure 170 is adjustable to different lengths and positions.

Although shown as a single straight member in FIGS. 6 and 10, the stabilizing structure 170 can be curved, can include multiple members, can be divided into a fishtail configuration, and within the pressure chamber 110. It can be shrinkable or can be separated from the pressure chamber 110. In one embodiment, the stabilizing structure 170 can include at least one elastic bow extending from the pressure chamber 110 and can be further adjusted to different positions or curvatures. The stabilization structure 170 facilitates the use and positioning of the pressure treatment device 100 by the user, and helps to avoid pressure points or discomfort by assisting the pressure treatment device 100 to be properly supported.

24, the pressure chamber 110 may be provided with a stabilizing structure 170, a positioning mechanism 172 and an adjustment piece 128.

As shown in FIG. 1, the pressure chamber 110 is configured such that the front and rear sides 116 and 118 of the pressure chamber 110 extend at a predetermined angle to provide a wide opening 120. The front side 116 of the pressure chamber 110 can be configured to be primarily straight to facilitate passage of the limb through the opening 120 and the receiving space without bending or rotating the limb. In certain embodiments, the back side 118 of the pressure chamber 110 can extend beyond the extension of the front side 116.

The pressure region of the pressure chamber 110 can communicate with the pump unit 190 having a conduit 188 on the rear side 118 of the pressure chamber. As long as the conduit communicates with the pressure region 124, embodiments of the device are not limited to a specific location of the conduit 188.

7 and 19, the piston 200 of the pump unit 190 may include a wing 202 for contacting the cylinder 204. As the piston 200 moves within the cylinder 204, non-atmospheric pressure is generated in the pressure chamber 110. The wing 202 reduces the friction between the piston 200 and the cylinder 204, thereby reducing the resistance of the cylinder 204 to the movement of the piston 200, thereby reducing the mechanical requirements to move the piston 200. To generate non-atmospheric pressure.

Since the piston 200 does not directly contact the cylinder 204, the geometric tolerance is increased and the piston 200 and/or cylinder can be manufactured by injection molding, which is molded from a mold, rather than a "perfect" cylinder shape. It needs to be slightly conical to allow removal of the part. The side of the molded part may have an inclination angle of 0.2°, forming a slightly conical shape.

Prior art methods of operating the piston 200 without the described wing 202 generally require more precise components such as metal and more expensive materials. The use of the injection molded parts according to the present application allows the piston 200 and/or cylinder 204 to be manufactured respectively as a single injection molded part, thereby reducing material cost and precision required for manufacturing. This is particularly advantageous because of the cost of manufacturing components that require precise fit; By using the wing 202, tolerances for different sized components are increased, which simplifies the cost and complexity of the manufacturing process, thereby reducing the cost of the piston 200 and cylinder 204.

In one embodiment, wing 202 may include an elastic material to adjust to the dimensions of piston 200 and cylinder 204. The use of an elastic wing 202 allows the piston 200 to be adjusted to the various dimensions of the cylinder 204. The adjustable properties of the piston 200 and the elastic wing 202 allow the manufacture of a low cost cylinder 204, in particular a shaped cylinder in which the first end of the cylinder can have a larger diameter than the second end. In one embodiment, the first end of the cylinder 204 can form an angle of up to 3° with the second end. The elastic wing 202 is configured to have a length and elasticity sufficient to seal the cylinder 204 along its entire length.

Referring to FIG. 8, a first valve system 210 is shown for opening and closing communication between the pressure region 124 and ambient atmospheric pressure. The first valve system 210 can include a pressure zone 124 and a closed passage 212 in communication with ambient atmospheric pressure. As shown, the passage 212 may include an elastic covering 216 on the ambient atmospheric pressure side and a chamfered washer 214 on the pressure region side, and an elastic covering 216 and a chamfered washer 214 Work together to define a wider central opening 218 in the chamfered washer 214 than the elastic covering 216. The sealing unit 220 is disposed in the passage 212 on the pressure region side of the chamfered washer 214.

According to one embodiment, the sealing unit 220 may include a ball having dimensions configured to close the central opening 218 by contacting the chamfered washer 214 and the elastic covering 216. Since the elastic covering 216 contacts the sealing unit 220, the geometric tolerance for the sealing unit 220 is increased and the sealing of the central opening 218 is improved.

When a negative pressure is generated in the pressure region 124, the sealing unit 220 is lifted from the central opening 218, and the sealing unit 220 is lifted and predetermined to allow communication between the pressure region 124 and the ambient atmospheric pressure. The central opening 218 remains closed until pressure is reached. The pressure region 124 may be configured to 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 at a pressure of 60-150 mmHg, more specifically 60-75 mmHg.

The chamfered washer 214 may include an additional opening 215 located on the side of the chamfered washer 214 so that the elastic covering 216 is opened in response to overpressure. The first valve system 210 operates as a safety valve.

The elastic covering 216 may be pre-stretched and secured to the passage 212 by the chamfered washer 214 and the walls of the passage 212. As shown in Fig. 8, the elastic covering 216 is fixed at a predetermined position and cannot be moved or pulled through the central opening 218 in response to negative pressure.

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 the ambient pressure, and the internal pressure of the pressure chamber can be adjusted to the ambient pressure.

A preferred method of using the pressure treatment device 100 is pressure treatment on the user's limbs. Pressure treatment may include the application of pulsating pressure or repeated alternating introduction of two or more different pressures over a continuous period of time. In one example, the pulsating pressure may include an operative introduction of the applied pressure and release of the applied pressure to return to approximately atmospheric pressure. The applied pressure can be positive pressure or negative pressure. In the embodiment using the negative pressure, the period in which the negative pressure is introduced and exists is the negative pressure period. Similarly, in a system using static pressure, the period during which static pressure is introduced and exists is a static pressure period. In each case, the period during which the applied pressure is released to return atmospheric pressure and is present is the atmospheric pressure period.

The embodiments discussed herein are discussed with respect to the applied negative pressure. In general, the negative pressure system can be easily replaced by a positive pressure system by reversing pump and valve operation or by other adjustments apparent to those skilled in the art. It should be understood that any discussion of the negative pressure system applies to the static pressure system as well, unless stated otherwise. In this case, the term "negative pressure" as used herein should be replaced by the term "static pressure" and the pressure value should be replaced as well. This disclosure should not be interpreted to exclude apparatus and methods that use static pressure rather than negative pressure.

In some embodiments, multiple consecutive alternating negative pressure periods and atmospheric pressure periods are applied to the limbs in the pressure chamber without removing the limbs from the chamber. The duration of the negative pressure and atmospheric pressure may be the same or different duration. In some embodiments, the negative pressure period and the atmospheric pressure period can be selected according to known methods, such as those described in co-owned US Patent Application Publication No. 2005/0027218 published Feb. 3, 2005.

In some embodiments, the negative pressure period has a duration of 1 second to 20 seconds and the atmospheric pressure period has a duration of 2 seconds to 15 seconds. In addition, in some embodiments, the duration of the negative pressure period is 5 seconds to 15 seconds, and the duration of the atmospheric pressure period is 5 seconds 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.

The pressure applied in the pressure chamber can be fixed or selected at the point of use. Embodiments of the apparatus and method according to the present disclosure enable application of 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 negative pressure of at least -80 mmHg (-10.7 kPa), preferably a much greater negative pressure. In some embodiments, the negative pressure can be -60 mmHg (-8.0 kPa) or less. Some embodiments employ a negative pressure of about -40 mmHg (-5.3 kPa). Preferred negative pressure is selected to reduce the problems that may occur by applying a higher negative pressure. In some embodiments, negative pressure is selected to promote localized vasodilation of the limb surface while minimizing the risk of possible problems. It has been found that pulsation of negative pressure promotes blood flow, preferably pulsating negative pressure of 0-40 mmHg (0-5.3 kPa) occurs in the pressure chamber.

According to one embodiment of the apparatus of FIGS. 20 and 27, the inflatable padding 140 is configured as a valve 192 to provide communication with ambient atmospheric pressure, and is preferably a one-way valve or check valve. The valve 192 may be positioned to surround the opening of the expandable seal and extend through the side of the pressure chamber 110 at a fixed knob 242 that extends through the opening of the pressure chamber 110.

In this embodiment, the inflatable padding 140 is expanded by applying a negative pressure in the pressure chamber 110, and there is no need to use any additional vacuum or pressure generating mechanism. Advantageously, if the inflatable padding 140 is provided with a valve 192, the inflatable padding 140 will expand in response to negative pressure and will secure the limb to a desired position within the pressure chamber 110. When multiple chambers are provided in the inflatable padding 140, each chamber is provided with a valve, or a three-way valve is provided for independent expansion and contraction.

The lever arm 222 may be positioned to displace the sealing unit 220 during the atmospheric pressure period and to contract during the negative pressure period. According to one embodiment of the pressure treatment device 100, when the piston 200 is driven and the motor is operated to generate non-atmospheric pressure, the torque of the motor is the lever arm 222 away from the central opening 218, the motor The lever arm 222 can be secured to the motor of the pump unit 190 to displace the sealing unit 220 only when is not used.

At the end of the negative pressure period and during the atmospheric pressure period in the pressure chamber 110, the inflatable padding 140 may provide overpressure to the user's limbs. By closing the valve 192, overpressure results from pressure changes in the pressure chamber 110 that the inflatable padding 140 cannot control. The overpressure on the user's limb applies a static pressure of about 10 mmHg to the user's limb during the atmospheric pressure period, and can increase blood flow through the user's limb by direct mechanical force.

The inflatable padding 140 may be constructed of a larger or smaller thickness material to adjust and control the amount of overpressure applied to the limb. The inflatable padding 140 may have a variable thickness to localize pressure or overpressure on the limb. Areas of greater thickness can be arranged to contact areas that require less pressure or pressure, while areas of less thickness can be arranged to contact areas that require more pressure. The thickness may be arranged based on required heat transfer characteristics or convenience needs.

In use, the inflatable padding 140 expands during the negative pressure period to secure the user's limb within the pressure chamber 110. After use, to enable the user to remove the limbs, the inflatable padding 140 is adapted to contract to release the pressure created during the negative pressure period of the pressure treatment device 100.

To contract the expandable padding 140 and expand the opening 120 of the pressure chamber 110 for insertion or removal of the user's limbs, the valve 192 is a lever operated valve 194, a timer valve ( 196) or a manually operated valve (not shown). According to FIG. 21, a lever-operated valve 194 may be provided outside of the pressure chamber 110 such that the seal 150 in the rolled back position actuates the lever and opens the valve 192. When the seal 150 is rolled to the user's limb, the valve 192 returns to the closed position and can expand in response to negative pressure. According to FIG. 22, a timer valve 196 may be provided outside the pressure chamber 110 so that the user operates the valve by pressing the switch 198.

As shown in FIG. 23, the switch 198 operates the valve 192 in the depressed position, but the spring 206 and the switch 198 slowly return to its original position to close the valve 192 and It is connected to the rotary damper 208. Spring 206 and rotary damper 208 can be configured to operate valve 192 for a period of time, which will cause the inflatable padding 140 to contract and remove the user's limbs. For a manually operated valve, a button may be provided that the user can press to activate the valve 192. The valve remains open only while the user presses the button. For example, in an embodiment with a three-way valve, the valve 192 can also be connected to the pump unit 190 to quickly retract the inflatable padding 140.

Difficult to customize for individual users, limited to pressure treatment technology, difficult to wear for users with limited agility or strength, uncomfortable and unhealthy due to pressure and contact between the pressure chamber and the wound or lancet of the user's limb The problem of a pressure treatment device that is dangerous due to an increase in degree or duration of non-atmospheric pressure is solved by providing a medical pressure treatment device according to embodiments of the present disclosure. The pressure treatment device of the present disclosure advantageously allows the user to wear the device intuitively and accurately without the help of a clinician. Due to the operation of the seal and inflatable pad, the device conforms to the user's dimensions and prevents the device from contacting the wound on the user's limb surface. The device further has a unique valve arrangement that provides an advantageous distribution of negative pressure to the limbs and an intermittent massaging effect while automatically alleviating the duration of harmful levels or pressures.

Case studies were adopted to demonstrate the efficacy of the pressure treatment device according to the present disclosure, and positive initial results were obtained.

In any of these studies, the effect of various pressure levels on the user's limbs was analyzed by employing the pressure treatment device of the present disclosure to treat a population of 16 samples suffering from peripheral arterial disease. More than 90% of the sample population in this study suffered mild claudication and was classified as stage 2 of the Fontaine stage for chronic limb ischemia.

A pairwise comparison of the effects of pressure levels of -10 mmHg, -20 mmHg, -40 mmHg, and -60 mmHg on flow and laser Doppler flux measurements of the legs and feet was performed, and statistically significant increases in flow and Doppler flux were shown in Table I and It looked like.

Table I

As demonstrated, embodiments of a pressure treatment device employing a negative pressure of about -40 mmHg (-5.3 kPa) show a significant improvement in blood flow through the limbs of patients suffering from peripheral arterial disease, thereby improving healing. Can be.

Further studies examined the effect of the pressure treatment device of the present disclosure on a person suffering from severe lower extremity ischemia. These people suffer from numerous symptoms, including chronic pain in the lower extremities and open sores or ulcers. In particular, a person who was unsuitable or unwilling to undergo angioplasty, that is, angioplasty, vascular bypass or other surgical procedures, was selected for treatment.

According to initial data from the study, chronic wounds worsened when an angiosurgery option was not available due to an increase in size of an average of 275% (SD 514%) of 5/7 of the original wounds in the standard treatment group and the occurrence of two new wounds. It has been found that there is a tendency to become. When the pressure treatment device of the present disclosure was used, wound healing was observed in 6/9 of the wounds present at the start of treatment, and the wound size was reduced by an average of 19% (SD 78%).

Along with changes in wound size, changes in the treatment and care of wounds have also been observed. In the control group, the number of dressings for managing wounds increased from an average of 1.67 to 3.67 times per week, while in the group treated with the pressure treatment device of the present disclosure, a decrease from 2.75 times per week to 1.75 times was observed. Since each wound dressing requires a physical cost for the dressing and a professional vascular nurse or podiatrist to assist, this represents an advantage of potential cost savings for the pressure treatment device of the present invention over prior art methods. .

The participant's foot pain was recorded on a visual analog scale, 0 was painless and 100 was the worst pain imaginable, in the control the foot pain increased slightly from 46 to 58, but treated with the pressure treatment device of the present disclosure. The group showed a decrease from 48.75 to 45.25. In addition, pain management through drug treatment was found to be different between the two groups due to a decrease in opioid analgesics in the treatment group versus the control group.

The case study clearly demonstrates the benefits of treatment with the pressure treatment device of the present disclosure, including increased wound healing, reduced treatment costs, reduced pain, and reduced need for opioid use. Similar advantages have not been achieved in the prior art.

As can be readily seen from the discussion above, the size, number, configuration and location of the medical pressure treatment device and its components can be determined by many different users with different sizes of joints and body parts from this design without custom fabrication and design. It is understood that it can be adjusted to obtain an advantage. It is understood that the placement of the inflatable pad, seal, positioning mechanism and other components can be replaced with what is shown to be advantageous to the user in terms of different dimensions and pathology.

Claims (36)

A pressure chamber 110 having a first end 112 and a second end 114, the first end 112 comprising: a pressure chamber 110 defining an opening 120;
An inflatable padding 140 located within the opening 120 and comprising a valve 192 in communication with ambient pressure;
A seal 150 fixed to the first end 112 of the pressure chamber 110 to seal the opening 120; And
A pressure treatment device (100) comprising a pump unit (190) connected to the pressure chamber (110) and configured to generate a negative pressure in the pressure chamber (110),
The inflatable padding 140 is a pressure treatment device 100 configured to narrow the opening 120 and fix it against the user's limbs in response to negative pressure generated in the pressure chamber by the pump unit 190. According to claim 1,
The expandable padding 140 is a pressure treatment device 100 configured to expand due to overpressure when the generation of negative pressure by the pump unit 190 ends. The method of claim 1 or 2,
The inflatable padding 140 includes at least a front air chamber and a rear air chamber, the rear air chamber having a longer length than the front air chamber of the inflatable pad 140. The method according to any one of claims 1 to 3,
The pump unit 190 includes a first valve system 210 including a chamfered washer 214 and an elastic covering 216 that define a central opening 218 of the passage 212, a sealing unit 220 is a pressure treatment device 100 positioned on a chamfered washer 214 for closing the central opening 218. The method according to any one of claims 1 to 4,
The seal 150 includes a truncated conical cuff having a first end 152 and a second end 154, the first end 152 eccentric to the central axis of the second end 154 Pressure treatment device 100 having a central axis. The method according to any one of claims 1 to 5,
The pump unit 190 includes a piston 200 and a cylinder 204, and the piston 200 includes a wing 202 extending from the piston 200 to the cylinder 204. (100). The method according to any one of claims 1 to 6,
A pressure treatment device (100) is provided on the outer surface of the pressure chamber (110) with a first locking element (126) for fastening to the adjustment piece (128). The method according to any one of claims 1 to 7,
The second end 114 of the pressure chamber is a pressure treatment device 100 comprising a support surface 130 having a flat portion 132 and an angled portion 134. The method of claim 8,
The interior of the support surface 130 is a pressure treatment device 100 comprising a positioning mechanism 172 for receiving a foot of the limb. The method of claim 9,
The positioning device 172 is a pressure treatment device 100 including a narrow arch shape corresponding to the arch of the foot. The method according to any one of claims 1 to 10,
The first end 112 of the pressure chamber 110 is provided with at least one second locking element 136 for fastening to an inflatable padding 140 on the outer surface of the pressure chamber 110. Device 100. The method according to any one of claims 1 to 11,
The pressure chamber 110 is provided with an adjustable stabilizing structure 170 extending from the second end 114, the pressure treatment device 100. The method according to any one of claims 1 to 12,
The second end 114 of the pressure chamber 110 is a pressure treatment device 100 comprising a support surface 130 having a modular space 182 configured to receive a plurality of modular components 180. The method of claim 13,
The plurality of modular components 180 are pressure treatment devices 100 that include heating units, cooling units, vibration units, and/or electrical stimulation units. The method according to any one of claims 1 to 14,
The pressure chamber is provided with a conduit 188 in communication with the pump unit 190, the pressure treatment device 100. The method according to any one of claims 1 to 15,
The front outer surface and the rear outer surface of the pressure chamber 110 include the second end of the pressure chamber 110 in which a distance between the front outer surface and the rear outer surface follows the height of the pressure chamber 110 ( 114) pressure treatment device 100 forming a certain angle to continuously increase toward. The method according to any one of claims 1 to 16,
The front outer surface is straight and the pressure treatment device 100 is configured to extend at an angle from the opening 120 of the pressure chamber 110. The method according to any one of claims 1 to 17,
The expandable padding 140 is a pressure treatment device 100 extending beyond the first end 112 of the pressure chamber 110 at a distance of 5-20 mm. The method according to any one of claims 1 to 18,
The seal 150 includes a first end 152 and a second end 154, and the second end 154 is the second end 154 to the first end 152 in an elongated configuration. Pressure treatment device 100 having at least one projection 156 for fixing the. The method according to any one of claims 1 to 19,
The seal 150 includes a first end 152 and a second end 154, and the first end 152 is a pressure treatment device 100 having a thicker thickness than the second end 154. The method according to any one of claims 1 to 20,
The seal 150 is a pressure treatment device 100 comprising heat-pressed silicone, TPE or TBE. The method according to any one of claims 1 to 21,
The seal 150 is a pressure treatment device 100 having a thickness of 1 to 2 mm. The method according to any one of claims 1 to 22,
The seal 150 is a pressure treatment device 100 comprising a material having a Shore A value in the range 0-15. The method of claim 23,
The seal 150 is a pressure treatment device 100 comprising a material having a Shore A value of 5. The method according to any one of claims 1 to 24,
The valve 192 is a pressure treatment device 100 comprising a lever 194 for opening the valve against ambient pressure. The method of claim 6,
The wing 202 of the piston 200 comprises a pressure treatment device 100 comprising an elastic material. The method of claim 6,
The wing 202 of the piston 200 is a pressure treatment device 100 that is configured to bend in response to a pressure of 20 ~ 150mmHg. The method of claim 4,
The sealing unit 220, the pressure treatment device 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 ~ 150mmHg. The method of claim 4,
The sealing unit 220 is a pressure treatment device comprising a steel ball. The method of claim 4,
The first valve system 210 is provided with a leverage arm 222 configured to displace the sealing unit 220 when the pump unit 190 is operated to generate non-atmospheric pressure. . The method of claim 4,
The chamfered washer 214 is configured to define an additional opening 215 therethrough. The method of claim 31,
The elastic covering 216 is a pressure treatment device configured as a valve on the additional opening 215. A pressure chamber (110) having a first end (112) and a second end (114), wherein the first end (112) obtains a pressure chamber (110) defining an opening (120);
Providing an inflatable padding (140) in the opening (120) of the pressure chamber (110) comprising a valve (192) in communication with ambient pressure;
Providing a seal (150) secured to the first end (112) of the pressure chamber (110) to seal the opening (120) and surround the expandable padding (140 ), wherein the seal ( 150) is an open configuration;
Inserting a limb through the seal 150, the inflatable padding 140, and the opening 120 of the pressure chamber 110;
Closing the seal 150 with respect to the limb in the opening 120; And
A method of using a pressure treatment device (100) comprising inflating the inflatable padding (140) and generating a negative pressure in the pressure chamber (110) to secure the limb within the opening (120). The method of claim 33,
Releasing a negative pressure in the pressure chamber 110 and massaging the inflatable padding 140 to massage the limb. The method of claim 33,
The inflatable padding 140 is provided with at least two air chambers. The method of claim 35,
And operating the lever mechanism (194) of the valve to retract the inflatable padding (140).

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