CN111148496A - Medical pressure treatment device and component of a medical pressure treatment device - Google Patents

Abstract

A pressure therapy device (100) includes a pressure chamber (110), an inflatable cushion (140), a seal (150), and a positioning mechanism (172). The pressure chamber (110) has an opening (120) arranged for receiving the inflatable cushion (140) and a limb of a user. The inflatable cushion (140) is inflatable to enclose and secure the limb in place. The seal (150) covers the opening (120), including the inflatable cushion (140) and the limb, so as to seal the pressure chamber (140) from ambient atmospheric pressure. A pump unit (190) is provided for generating a non-atmospheric pressure within the pressure chamber (110), and includes a first valve system (210) and a piston (200) having a safety release feature for preventing unsafe pressure levels.

Description

Medical pressure treatment device and component of a medical pressure treatment device

Technical Field

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

Background

Many medical conditions can be treated by applying pressure to the body of a patient in a controlled manner. A healthcare professional or emergency medical professional may apply pulsating pressure to the patient's body, such as by massaging, to increase the blood velocity at or in adjacent areas to the area where the pulsating pressure is applied. Such pressure therapy can provide a number of benefits by increasing peripheral circulation and/or lymphatic circulation, promoting blood flow, affecting redistribution and diffusion of blood flow, promoting healing of tissues (e.g., wound healing and new blood vessel growth) by increased blood flow, and increasing the flow of substances between blood vessels and cells by increased diffusion.

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

Pressure therapy is also commonly employed in conjunction with external heating or cooling to treat patients suffering from overheating or overcooling, such as heat stroke or hypothermia, to help quickly regulate the temperature of the patient. The pulsatile pressure may increase the rate at which temperature changes of the patient's limb are transferred to the core region of the patient, thereby enabling more effective regulation of the patient's core temperature than if the patient's limb were heated or cooled without pressure treatment.

In other cases, it may similarly be desirable to heat or cool the patient for therapeutic purposes. This may occur during chemotherapy, before, after or during surgery, and where metabolism should be reduced, for example during stroke or cardiac arrest. In other cases, it may be desirable to pre-warm the patient prior to performing anesthesia to prevent or reduce hypothermia.

In its most basic form, a trained medical professional may administer pressure therapy in the form of a manual massage, but some efforts have been made to improve and automate pressure therapy with pressure therapy devices. These devices can apply more precise pressure levels than massage, and can apply negative and positive pressures against the limb during treatment.

However, the use of pressure therapy devices in clinical practice is relatively new and has been identified with little improvement or advancement other than the conventional application of pressure to a portion of a limb. There remains a need to develop new features in pressure therapy devices to increase blood flow.

In order to apply pressure to the body of a patient, known pressure therapy devices typically establish a controlled pressure environment, such as a pressure chamber, around the area of the user where the pressure is to be controlled. The pressure may then be regulated within the closed environment of the pressure chamber by removing air from the pressure chamber or adding air to the pressure chamber.

For example, where pulsating pressure is to be applied to a patient's leg, a controlled pressure environment may be established around the patient's foot and with the lower leg directed upward toward the thigh. This may involve positioning the patient's leg in a pressure chamber that isolates at least a portion of the leg from the surrounding environment.

Proper placement of a patient's limb in a pressure chamber is often difficult because users requiring medical pressure treatment often suffer from mobility and mobility limitations due to age or other diseases that are increasingly debilitating in their condition as described above. Known pressure systems are also typically large and difficult to adjust, while also being complex to operate and requiring the assistance of a trained medical professional to be safely and effectively used.

During the application of negative pressure in known devices, the negative pressure environment created within the pressure chamber may pull the limb of the patient deeper into the pressure chamber and against the interior edges or surfaces of the device. This can cause pressure points on the patient's limb, potentially limiting blood circulation through the patient's limb, and cause contusions, discomfort, necrosis or other adverse effects.

Patients with the above-listed diseases also typically have fragile skin that may be damaged unless properly protected from edges and protrusions. If the patient's limb is pulled into the closed end of the pressure chamber, contact between the patient's limb and the walls of the pressure chamber may create high pressure contact points that can damage the delicate skin. This may pose a particular risk to patients with neuropathy and/or limited skin blood flow.

In other devices, the limb may be supported or protected by pad structures that must be custom fitted or shaped for the individual user to provide adequate support and avoid pressure points on the limb. Personal assembly requires additional time, materials, and assistance from trained technicians. Alternative approaches in the prior art may involve building pressure chambers on the limb or building pressure chambers to fit the limb, which as such are expensive and difficult to build.

Sealing the pressure chamber around the patient's limb is also difficult due to irregular changes in the user's anatomy, plus the need for a large opening to allow insertion of the leg with limited ankle mobility. Prior art methods typically require resilient sealing means under high tension, which are often uncomfortable to the user, prior art methods typically require assistance for application, and prior art methods can cause pressure points on the skin and are difficult for the user to adjust.

In view of the above, known negative pressure systems are not configured for use by non-specifically trained patients, and may require specific fittings, complex components, and pressure generators to ensure that the proper level of pressure is generated and released without damaging the patient's delicate limbs. These complex systems tend to be expensive to manufacture and are limited in consumer size by excessive cost of use.

It is noteworthy that the difficulty of using known pressure therapy devices may prevent the patient from receiving the desired therapy. It is also of concern that the pressure therapy device may be used incorrectly, without intervention by a trained technician, resulting in ineffective and/or potentially harmful pressure levels or limb positioning.

It is desirable to provide only a small number of size components for a pressure treatment device, thereby minimizing customization requirements while providing increased support to the limb of the patient and maximizing exposure of the limb to pressure treatment. There is a need for a medical pressure treatment device that allows for simple placement and adjustment of a pressure chamber around a limb, the device comprising means for sealing and applying pressure treatment to the limb while improving the efficacy of the pressure treatment actuated on the limb by the device.

It is also desirable to provide a pressure treatment apparatus with safety features that ensure that the apparatus is simple and safe to operate both inside and outside of a clinical environment, and that it can be produced inexpensively.

As such, there is a need for a pressure treatment device that has more advanced functionality than simply applying negative or positive pressure to a portion of a limb.

Disclosure of Invention

According to embodiments described herein, a pressure treatment device is provided for performing pressure treatment for a user, in particular on a limb of a patient. Pressure treatment devices enable the application of pressure to a limb within an enclosed environment while providing superior comfort fit, safety features, improved support of the limb, and simple placement of the limb.

The improvements to pressure therapy devices over prior art devices and methods may include novel components including pressure chambers, seals, inflatable cushions, and internal positioning mechanisms for supporting a patient's limb. The pressure therapy device may also be provided with a novel pump unit and valve system configured for improving the safety and usability of the device.

Indications for pressure therapy devices may include open wounds, diabetic ulcers, diseases caused by inactivity, spinal cord injury, lymphedema, atherosclerosis, heat stroke, hypothermia, stroke, heart disease, bone fractures, inflammation, swelling, tendonitis, muscle injury, or cancer.

Various embodiments of the present pressure treatment device provide significant improvements in donning and fitting procedures over known pressure treatment devices. The donning and fitting process can be performed without the need to make measurements and cater for the user's anatomy and physical abilities. In particular, embodiments according to the present disclosure enable a patient to perform the donning and fitting of the device without assistance.

The pressure therapy device is also configured to adapt to the size and shape of the individual patient without intervention of a technician or other professional such that the device is customized for optimal fit and performance.

Embodiments of the present disclosure may include a pressure chamber with streamlined features including a large opening and an angled neck to facilitate insertion of the limb without bending the joint and to allow the limb to be in a relaxed position during use. The bottom surface of the pressure chamber may be made of a molded material and provided with a flat base with inclined ends.

In comparison to known devices, the pressure therapy device may be arranged to be adjustable by a user in a seated position by providing means for lifting and rotating the device from a distance, thereby increasing the ease of use and comfort of the user during use. The pressure treatment device may be adapted to cooperate with external support features to hold or reposition the device in a preferred position.

These functions reduce weight, size, and bulk relative to known pressure treatment devices, and allow the device to be worn without the need to over-force or bend and turn the limb.

According to one embodiment of the pressure therapy device, the pressure therapy device comprises a pressure chamber having a first end and a second end and an outer front surface and an outer rear surface. The first end defines an opening configured to widen from the receiving area to a pressure area adapted to receive and encircle a limb.

Where prior art devices typically have a unique boot shape that narrows at the user's ankle or lower leg, embodiments of the present disclosure may include a large opening and interior area. The opening may be configured to extend into the receiving area and form a predetermined size of a short "neck" prior to expansion into the interior of the pressure chamber so that the limb may pass through without rotating or bending the limb, which is often difficult or painful for the user. The user's foot and lower leg may be introduced through the opening and neck of the pressure chamber at a 90 angle without turning or bending the ankle.

The outer front surface and the outer rear surface of the pressure chamber may form an angle such that a distance between the front surface and the rear surface increases along a height of the pressure chamber at a predetermined rate toward the second end of the pressure chamber. This arrangement allows a wide opening to be spread into a wider area of the chamber, particularly in the front face, without tight angles.

According to an embodiment of the pressure chamber, the front surface may be configured to be straight and extend at a constant angle from a neck of the opening of the pressure chamber. The straight surface advantageously 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 may be painful or otherwise make it difficult to put on and take off the device.

The second end of the pressure chamber is closed by a support surface having a flat portion and an angled portion at least at the rear end. The angled and flat portions are adapted to allow angular adjustment and stable placement of the pressure chamber during insertion into the limb and during operation of the device.

The angled portion may be a heel support for stabilizing the pressure chamber in an upright position when inserting or removing the limb from the pressure chamber. With the pressure chamber in an upright position, the user can insert the limb without turning or bending the limb. The user's foot and lower leg may be inserted from the seated position without turning the ankle by simply lifting the leg and extending the knee.

Once the limb is in contact against the lower surface of the pressure chamber, the pressure chamber may be rotated forward to rest on the flat portion for obtaining a stable, comfortable and continuous treatment position.

The support surface may comprise a friction enhancing material, such as a rubber-like material, on the outer surface to prevent the pressure chamber from slipping when in use.

The outer surface of the pressure chamber may also be configured to be transparent and may include instructions for properly positioning the limb so that the user can clearly see the limb when positioning the limb. Clearly seeing the positioning of the limb is beneficial to a user with neuropathy who may lack the ability to feel pressure or feel on the limb and must be able to see a free-floating limb.

The outer front surface may include a first locking element configured to engage the adjustment member. The adjustment member may extend toward the first end of the pressure chamber for manipulation by a user and may be removably secured to the pressure chamber at a location proximate the opening to increase leverage. The adjustment member may comprise a detachable handle and the adjustment member will allow the user to increase control over the positioning of the pressure chamber during use.

Embodiments of the pressure treatment device may secure and position a limb of a user within the pressure chamber using an inflatable cushion and a seal at a first end of the pressure chamber. The first end may comprise a second locking element for securing the inflatable cushion through the opening and in the receiving area of the pressure chamber.

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

The seal may be configured to surround the opening of the pressure chamber and the inflatable cushion and engage the second locking element without additional straps.

In one embodiment, the inflatable cushion may engage with a second locking element on an exterior surface of the first end of the pressure chamber at a predetermined location and extend into the opening and receiving area of the pressure chamber. In an alternative embodiment, the inflatable cushion may engage with a second locking element on an interior surface of the first end of the pressure chamber.

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

The inflatable cushion may be provided with a valve for inflation and deflation with limited intervention by the user. The valve may be a check valve, a check valve or a one-way valve adapted to inflate the inflatable cushion by drawing air from the ambient environment into the inflatable cushion in response to a negative pressure in the pressure chamber and to deflate only when the valve is opened by a user or at predetermined time intervals.

The use of a one-way valve using negative pressure allows the inflatable cushion to be automatically inflated during operation of the pressure therapy device and it has been surprisingly found that an additional massaging effect is provided on the limb of the user during therapy. The massage effect is generated as a result of the proximity of the inflatable cushion to the ambient pressure, such that after releasing the negative pressure in the pressure chamber, an overpressure is generated within the inflatable cushion.

In the event that negative pressure draws blood into the user's limb, the overpressure causes the inflatable cushion to slightly squeeze or massage the user's limb while the user's limb is released from the effect of the negative pressure in the pressure chamber (e.g., when atmospheric pressure is restored). This squeezing or massaging action helps to accelerate blood drawn into the user's limb by negative pressure and increases blood flow through the limb.

By utilizing the existing dynamism between negative pressure and atmospheric pressure, the dual benefits of negative pressure around the limb in combination with positive pressure applied by the inflatable cushion are simply realized; that is, the introduction of negative pressure causes the inflatable cushion to automatically inflate. A massaging effect is achieved without the need to generate positive pressure in the pressure chamber and allows the pressure therapy device to apply positive and negative pressure to the limb without a complex pumping system.

The valve of the inflatable cushion may be configured as a lever actuated valve that opens when the seal is pulled away from the user's limb, as a timed valve, or as a manually actuated valve so that the user can easily deflate the inflatable cushion to remove the limb from the pressure chamber.

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

The thickness of the material of the inflatable cushion may be configured so that a greater or lesser pressure or overpressure is applied to the limb. In the case where the material of the inflatable cushion is thicker or more elastic, the inflatable cushion resists expansion, while the opposite occurs when the material of the inflatable cushion is a thin or flexible material.

In one embodiment, the inflatable cushion includes at least two air chambers so that the limb can be properly positioned in the pressure chamber. The use of an inflatable cushion with only one air chamber is not uniform in filling as the air in the cushion will redistribute according to the resistance provided by the limb. Where the inflatable cushion includes only one air chamber, the cushion may not properly position the limb, but may allow the limb to rest against the side or back of the pressure chamber due to its weight and position.

The inflatable cushion may comprise a seamless material, a single molded material, or a material having multiple welds. Thus, the inflatable cushion may present a smooth interior surface without protrusions or recessed areas that may cause discomfort, depressions, or marks on the user's skin.

The inflatable cushion may be made of PVC or PUR and may have a flocked surface. PUR materials are advantageous because they provide increased friction relative to PVC or flocked materials. The inflatable cushion may be provided with different surface types or treatments, such as an adhesive surface for better retention of the user's limb, a smooth surface, or a pad surface for increased comfort for the user.

In some configurations, the inflatable cushion may have a uniform length, or may have a shorter front length than a back length, to better grip the back portion of the limb and to better support the limb on the resting side (e.g., the back side of the leg). The inflatable cushion may also extend beyond the opening of the pressure chamber in the proximal direction in order to better grip the limb and protect the limb from the edges of the opening of the pressure chamber.

In one embodiment, the inflatable cushion may have an extension of 5mm to 20mm 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 therapy device is configured to surround the opening of the pressure chamber at the first end of the pressure chamber and the inflatable cushion such that a portion of the limb of the user is enclosed in the pressure chamber. The seal is configured to tightly grip the user's limb such that the interior of the pressure chamber may be isolated from ambient pressure.

The seal may comprise a frusto-conical sleeve or cone of resilient material having a first end and a second end. The first end of the cuff may be adapted to engage with a second locking element located at the first end of the pressure chamber and may have a reduced diameter as the first end extends away from the opening to the second end of the cuff. The second end of the sleeve may be positioned off-center relative to the first end with the central axis of the second end of the sleeve being behind the central axis of the first end of the sleeve to naturally position the limb in a preferred position without user intervention.

It has been found that the use of a frusto-conical sleeve with the second end eccentric relative to the first end advantageously allows the seal to readily and intuitively conform to irregular shapes of the user's anatomy. In particular, the shape of the described seal may close small depressions or furrows in the user's anatomy, such as are common on the anterior surface of the lower leg from which the tibia may protrude in a narrow and long manner.

The surface of the seal may be provided with a friction enhancing material or with a smooth surface to improve the seal against the limb and to facilitate rolling back and securing the seal around the opening of the pressure chamber during insertion into the limb. The first end of the seal may also be provided with a projection for securing the seal in an open or rolled position.

The seal preferably has a length sufficient to engage the limb of the patient around the predetermined distance to ensure a good seal and prevent the formation of pressure points. The outer surface of the seal may be provided with instructions for trimming or cutting to adjust the length of the seal or the diameter of the second end of the seal.

Because the seal is configured to tightly grip the limb of the user, the outer surface of the seal may be provided with a pull tab to facilitate intuitive grasping and opening of the seal by the user.

The seal may comprise an elastomeric material and the seal may be configured to have a variable thickness such that the first end of the cuff is thicker than the second end. The thicker material of the first end enables a safer attachment to the pressure chamber, while the thinner material of the second end facilitates the opening and the rolling back of the seal by the user. The seal may be manufactured by injection moulding, wherein the injection point comprises the periphery of the second end of the sleeve, to avoid a single injection point which is prone to tearing after repeated use, and an uncomfortable fused seam.

Modular components may be added to certain embodiments of the medical pressure treatment device to enable additional treatment options to be applied to the limb. Examples of modular components that may be coupled with the pressure therapy device may include heating or cooling units, vibration units, electrical stimulation units, and the like. The modular components improve the efficacy of the medical pressure treatment device in treating specific diseases (including hypothermia, heat failure, etc.), and the modular components can be placed in modular spaces in the support surface of the pressure chamber. The modular space may be configured to receive a plurality of replaceable modular components having different functions.

In one embodiment of the pressure therapy device, the exterior of the pressure chamber is provided with a stabilizing structure to maintain the pressure chamber in a predetermined position, such as to facilitate a seated position for a user. The stabilizing structure may be adjustable to different lengths, and the stabilizing structure may include at least one stabilizing member secured to the pressure chamber. The at least one stabilizer may be curved or straight and the at least one stabilizer may cooperate with an adjustment mechanism provided on the pressure chamber.

In other embodiments, the stabilizing structure may be separate from the pressure chamber, and the stabilizing structure may be configured to adjust according to the position of the pressure chamber and hold the pressure chamber in place with, for example, a beanbag, sling, or inflatable pillow.

The pressure chamber may include a positioning mechanism within the pressure chamber for indicating and supporting 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.

It has been demonstrated that the use of a positioning mechanism improves the usability of the pressure therapy device by facilitating continuous and correct positioning of the limb within the pressure chamber, and surprisingly achieves a further massaging effect during the negative pressure cycle to force blood out of the vascular bed beneath the foot. The positioning mechanism may be configured to contact the user's limb only at certain points, such as at certain points in the arch of the foot, to avoid wounds typically found on the heel or footpad.

In an alternative embodiment, the positioning mechanism may be configured to extend from the pressure chamber in a releasable configuration such that when a user's limb contacts the positioning mechanism, the mechanism moves away from the limb to prevent the mechanism from contacting the limb after positioning of the limb is completed. The use of a releasable positioning mechanism allows for continuous positioning of the limb while allowing the limb to freely drop within the pressure chamber. In another embodiment, the positioning mechanism may fall in response to the negative pressure.

This free-falling configuration may be advantageous when a wound is present on the bottom of the user's limb.

According to an embodiment of the pressure therapy device, the pressure chamber is connected to a pump unit for providing a non-atmospheric pressure within the pressure chamber. The pump unit may provide the alternating pressure such that the first period of non-atmospheric pressure is followed by a second period of non-atmospheric or atmospheric pressure. Other embodiments and descriptions are provided in U.S. patent No.7,833,179 issued on day 11/16 of 2010, U.S. patent No.7,833,180 issued on day 11/16 of 2010, U.S. patent No.8,021,314 issued on day 9/20 of 2011, U.S. patent No.8,361,001 issued on day 1/29 of 2013, U.S. patent No.8,821,422 issued on day 9/2 of 2014, and U.S. patent No.8,657,864 issued on day 2/25 of 2014.

The pump device may include a first valve system configured to operate as a one-way valve with a safety release feature. The first valve system may include a chamfered gasket for closing a pipe or line. The chamfered gasket may include a through hole, and the chamfered gasket is placed against an elastic cap configured to mate with the pipe and close the through hole of the chamfered gasket.

The chamfered gasket and the elastomeric cover define a central opening that provides communication between the atmosphere or pump side and the pressure area side of the pipe or valve. A sealing unit (such as a ball) is configured to fit the size of the central opening and seal the first valve system closed. Due to the chamfered edge and the elastic cover, the sealing unit can be designed with high tolerances while still preventing leakage.

At a predetermined pressure level, the sealing unit may be moved from the central opening to allow communication with atmospheric pressure, thereby preventing the internal pressure from reaching unsafe levels. In the first valve system, the mass of the sealing unit and the size 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 gasket may define additional openings not defined by the elastomeric cover. In this configuration, the resilient cover acts as a one-way valve, leaving the additional opening or through hole open to allow air to be removed from the pressure area side during pump operation and to seal the negative pressure on the pressure area side when the pump is idle. The additional opening is closed by an elastic cover under negative pressure and is opened under positive overpressure.

The resilience of the resilient cap may be configured to calibrate the first valve system to a predetermined pressure range. The elastic cover may also be pre-stretched to prevent the cover from moving or stretching into the central opening or additional holes.

In one embodiment, the first valve system may include a lever arm configured to displace the sealing unit at a predetermined time or in response to a predetermined event to control the application and release of non-atmospheric pressure. In an embodiment, the lever arm may be adapted to displace the sealing unit when the pump unit is activated, such that the pump unit may remove air from the pressure area side, and to release the sealing unit when the pump unit is deactivated, such that the opening is sealed.

The first valve system or pressure chamber may also be provided with a permanently open or leak valve. The leak valve is configured to provide a small opening to atmospheric pressure so that the pressure within the chamber is slowly adjusted back to atmospheric level when the pump unit is not operating. The use of a leak valve helps to prevent misuse such as unsafe pressure levels and/or pressure levels that remain during unsafe periods of time.

A similar leak hole may be provided on the inflatable cushion and covered with tape to seal the hole so that if the valve of the inflatable cushion fails, the user can remove the tape and empty the inflatable cushion.

The pump unit may include a piston configured to generate a non-atmospheric pressure. The piston may include elastic extensions or wings to increase engineering tolerances and reduce friction between the piston and the cylinder. The wings may also be configured with a predetermined elasticity such that the wings fold inwardly in response to a predetermined pressure and prevent unsafe pressure levels from developing.

The pressure therapy device may comprise a control unit for causing the pump unit to operate, the control unit comprising a processor and a memory. The control unit may include sensors provided in the pressure chamber or other components, or on the limb of the user, for monitoring and recording the treatment results. The control unit may be programmed by the user or a medical professional and may be provided with software to ensure compliance with the personalized treatment regimen.

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

The pressure therapy device may be provided as a kit comprising a combination of pressure chambers, inflatable cushions, pump units, control units and/or seals. Due to the advantageous configuration of the individual components, the pressure therapy device can be configured by a technician or by a user according to the needs and anatomy of the particular user.

A method of using the pressure therapy device may include inserting a limb of a user through an opening of a pressure chamber such that the pressure chamber, seal, and inflatable cushion enclose the limb. The inflatable cushion may be in a deflated state when inserted into the limb, and the seal may be in a retracted or rolled-up position so that the limb has room to pass through the opening of the pressure chamber without rotating the limb.

Inserting the limb may further comprise rotating the position of the pressure chamber such that the pressure chamber is in an upright position by the flat portion of the lower surface when the limb is inserted. The limb may then contact the positioning mechanism within the pressure chamber and the pressure chamber may be rotated to lie on the flat portion of the lower surface.

The seal can then be stretched or deployed to fit against the user's limb and cover the opening of the pressure chamber and the inflatable cushion in the pressure chamber.

Upon actuation of the pump unit, the pump unit draws air out of the pressure chamber through a conduit in the pressure chamber. In response to the negative pressure, the inflatable cushion inflates through the valve and immobilizes the limb in the opening of the pressure chamber, away from the edges and interior surfaces of the pressure chamber. The negative pressure likewise pulls the seal against the user's limb and separates the interior of the pressure chamber from atmospheric pressure.

The negative pressure is applied to the limb in a pulsating manner, while the inflatable cushion remains inflated during periods of overpressure and exerts a positive massaging effect on the limb.

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

Drawings

Fig. 1 shows a perspective view of a pressure therapy device.

FIG. 2 shows a perspective view of a pressure chamber with and without an inflatable cushion.

Fig. 3 shows a perspective view of a pressure treatment device with a seal in an extended position and a retracted position.

Fig. 4 illustrates a perspective view of a pressure treatment device configured with an adjustment member and a method of donning and doffing.

Figure 5 shows a perspective view of the adjustment of the seal around the limb of the patient.

Fig. 6 shows a perspective view of a pressure treatment device with a stabilizing structure.

Fig. 7 is a plan view of the piston of the pump unit.

Fig. 8 is a plan view of a first valve system of the pump unit.

Fig. 9 is a plan view of a first valve system of the pump unit with lever arm.

Fig. 10 is a perspective view of an image of a pressure treatment device having a stable structure.

Figure 11 shows a perspective view of a seal for use with a pressure therapy device according to the present invention.

Fig. 12 shows a side perspective view of the seal of fig. 11.

Fig. 13 shows a top perspective view of the seal according to fig. 11.

Fig. 14 shows an enlarged perspective view of at least one second locking element on the interior of the pressure chamber.

Fig. 15 shows a plan view of an example of an aperture corresponding to at least one second locking element.

Fig. 16 shows a plan view of a positioning mechanism having a collapsible configuration.

Fig. 17 shows a perspective view of a pressure chamber with a positioning mechanism.

FIG. 18 illustrates a side perspective view of a pressure chamber having a positioning mechanism.

Fig. 19 shows an enlarged perspective view of the piston with resilient wings.

Fig. 20 shows side-by-side plan views of the valve in the on and off configurations.

FIG. 21 illustrates a side perspective view of a pressure chamber having a rod actuated valve mechanism.

FIG. 22 shows a side perspective view of a pressure chamber with a timing valve mechanism.

FIG. 23 is a side-by-side detailed view of the timing valve mechanism including a spring and a rotational damper in an actuated state.

FIG. 24 is a perspective view of a pressure chamber system including multiple components.

FIG. 25 is a bottom perspective view of a pressure chamber having differently angled portions on the rear and front sides.

Figure 26 is a side view of the pressure chamber moved from an upright position to a position where a user's limb is on the lower surface.

FIG. 27 is a perspective view of an inflatable cushion.

Fig. 28 is a perspective view of the positioning mechanism.

Detailed Description

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

A number of pressure treatment device embodiments and components for use with pressure treatment devices are described herein, with particular attention directed to devices and components directed to the limb. The limb may be any part of the human or animal body that can be easily introduced into the device. A limb may comprise an arm or leg, a portion of an arm or leg (e.g., a forearm, hand, calf or foot), or more than one such body part. Although the pressure treatment device is described in the context of a preferred embodiment for the lower leg and foot, many of the features described herein may extend to components for immobilizing other limbs and body parts as well as pressure treatment devices.

Pressure treatment device embodiments and components for use with pressure treatment devices may be sized to accommodate different types, shapes, and sizes of human joints and limbs. Additionally, the embodiments may be modified to determine the direction of the principle force applied by the pressure system of an embodiment at any desired location. The embodiments may be further modified to secure the device to the limb at any desired location.

For purposes of illustration, various pressure treatment device embodiments or components of pressure treatment devices described herein may be divided into portions that are represented by general anatomical terms of the human body. Such anatomical terms are provided to distinguish various elements of the device embodiments from one another, but should not be construed to limit the scope of the present disclosure.

By way of example, each of these terms is used with reference to a human leg that is divided into similar sections by a proximal-distal plane. The terms "proximal" and "distal" generally refer to a position of the device that corresponds to a position of the leg relative to a point at which the leg is attached to the body. The terms "upper" and "lower" may be used in conjunction with "proximal" and "distal" to denote a hierarchy in the "proximal" and "distal" positions.

Embodiments of the pressure treatment apparatus may also be considered to fall within the "anterior" and "posterior" portions of the anterior-posterior plane. The anterior-posterior plane generally corresponds to the coronal or frontal plane of a human limb located along the central longitudinal axis of the body. Thus, the posterior side or element is located posterior to the anterior-posterior plane, while the anterior side or element is located anterior to the anterior-posterior plane.

The term "inwardly" or "inner" is used generally herein to distinguish one side of the device that may be specifically adjacent to a limb of a user of the device. Conversely, the terms "outward" or "outer" are used to refer to the side of the device opposite the side that is inward.

According to embodiments of the present disclosure, pressure therapy devices having advantageous configurations of pressure chambers, seals, inflatable cushions, positioning mechanisms, pump units, and the like are disclosed. These embodiments have the advantage that the pressure treatment device is easy to manoeuvre onto a limb, simple and safe to operate even by untrained users, and comfortable to use while improving the efficacy of the pressure treatment actuated by the device.

Fig. 1 shows an embodiment of a pressure therapy device 100 having a pressure chamber 110, the pressure chamber 110 having a first end 112 and a second end 114 and a front surface 116 and a rear surface 118. The front surface 116 may be provided with a first locking element 126 and the second end 114 defines an opening 120, which opening 120 opens into a receiving region 122 within the pressure chamber 110, which receiving region 122 widens in the distal direction to a pressure region 124.

The pressure area 124 of the pressure chamber 110 may communicate with the pump unit 190 via a conduit 188 located at the rear side 118 of the pressure chamber 110. Embodiments of the pressure treatment apparatus 100 are not limited to a particular location of the conduit 188, so long as the conduit 188 is in communication with the pressure region 124.

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

The inflatable cushion 140 is secured to the opening 120 of the pressure chamber 110 and extends through the opening 120 and into the receiving area 122. The inflatable cushion 140 is secured to the pressure chamber 110 by at least one second locking element 136, as shown in fig. 2 and 14. The at least one second locking element 136 may be disposed inside or outside of the pressure chamber 110, and the at least one second locking element 136 comprises a hook or extension for passing through a corresponding hole in the inflatable cushion 140, such that the inflatable cushion 140 may comprise an extension that overlaps the outer surfaces 116, 118 of the pressure chamber 110 before extending through the opening 120 and into the receiving area 122. The at least one second locking element 136 may have a total height of 1.5mm and comprise a widened top or protrusion having a height of 0.5 mm.

A portion of the inflatable cushion 140 provided with an aperture corresponding to the at least one second locking element 136 may be reinforced with an increased material thickness for better securing to the pressure chamber 110 and providing an audible confirmation or click indicating proper attachment. The increased material thickness may be provided by a plastic or fabric strip (such as hostaphan strip 240) secured to the inflatable cushion 140 or incorporated into the inflatable cushion 140. In one embodiment, the portion of the inflatable cushion 140 has a thickness of 0.35 mm. As shown by way of example in fig. 15, the aperture may be configured to have a shape corresponding to the second locking element 136.

The inflatable cushion 140 may comprise a stretchable or non-stretchable material, such as thin polyurethane or PVC having a thickness of less than about 1mm, and the inflatable cushion 140 may comprise a mattress mat or friction enhancing surface. The inflatable cushion 140 may be manufactured in a single mold or in two welds to reduce the presence of seams that may create pressure points or mark the user's limb. The inflatable cushion 140 may be provided with a plurality of chambers such that portions of the inflatable cushion 140 are individually inflated around the user's limb.

In one embodiment, the inflatable cushion 140 may be formed from an inner sheet and an outer sheet (such as a TPU sheet) that each form a cylindrical member. The ends of the sheet are then welded together to form an air chamber therein. As shown in FIG. 27, the strap 240 and the protrusion 242 may also be bonded or otherwise secured to the inflatable cushion. The straps 240 and protrusions 242 allow a user to only secure the inflatable cushion 140 to the pressure chamber 110 in the correct configuration and remove the inflatable cushion 140 for cleaning or replacement.

In the embodiment depicted in FIG. 1, the inflatable cushion 140 is inflated to grip the user's limb and narrow the opening 120 to a sealable size. The inflatable cushion 140 enables the use of very wide openings 120 and facilitates the placement of limbs having different sizes without requiring over-rotation or bending of the limbs and while still enabling effective sealing of the pressure chamber 110. The inflatable cushion 140 is configured to inflate and resize the opening 120 according to the anatomy of the user and compress around the limb.

The inflatable cushion 140 may be configured to have a greater distal extension along the posterior side of the user's limb than along the anterior side, as wounds are generally more prevalent on the anterior side of the limb. The reduced distal extension on the anterior side relative to the posterior side also allows the user to adjust the limb during treatment, thereby increasing the comfort of the user. Preferably the distal extension is constrained such that the distal portion of the limb is not in contact with the inflatable cushion, as wounds are generally more prevalent in the distal portion of the limb (e.g. heel and ball of the foot). This arrangement allows the inflatable cushion 140 to effectively guide and support the user's limb without applying undue pressure to sensitive or vulnerable areas.

In one embodiment, the inflatable cushion 140 may provide additional support and protection to the limb by extending 20mm beyond the pressure chamber 110 in the proximal direction. The inflatable cushion 140 may be configured to have a variable length such that the distal extension of the inflatable cushion 140 is shorter on the anterior side than on 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 region 124. The inflatable cushion 140 may also be provided with a striped friction material to better grip the limb.

The seal 150 is fixed to the pressure chamber 110, surrounds the opening 120 and extends beyond the pressure chamber 110 in the proximal direction. The seal 150 may be secured by the at least one second locking element 136 or by friction, such as friction against a limb. The seal 150 may be provided with a narrow opening 155 (as shown in fig. 12) to help secure and position the seal 150. The seal 150 may comprise an elastomeric material having enhanced frictional properties such that the seal 150 fits tightly around the limb of the user.

The seal 150 may comprise hot pressed silicon, TPE or TBE having a thickness of about 1mm-2 mm. Seal 150 may be constructed with a material having a hardness in the range of 0 shore a (shore a) -15 shore a, and more preferably a material having a hardness of about 5 shore a, such that the material is securely fixed around the limb of the user without leaving a depression or imprint.

As shown in fig. 3 and 11, the seal 150 may have a frustoconical shape including 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 more in the posterior portion P of the opening 120, as shown in fig. 12.

When secured around a user's limb, the pull tab 157 may be configured to extend along the distal length of the seal 150 to enable the user to grip and open the seal 150 around the limb. The proximal end 152 of the seal 150 may be rolled back in a distal direction to widen the opening of the seal 150 for placement or removal of the limb. A tab 156 may be positioned on the distal end 154 for frictionally retaining the seal 150 in the rolled position so that the user does not have to hold the seal 150 during placement of the limb. This feature enables the pressure therapy device to be used by individuals without sufficient strength, dexterity, or mobility to manipulate the seal while also manipulating the limb or pressure chamber 110.

In one embodiment, the seal 150 may have a variable thickness such that the distal end 154 secured to the pressure chamber 110 has a thickness (e.g., 2mm thickness) that is thicker than the proximal end 152 (e.g., 1mm thickness). The increased thickness of the distal end 154 ensures a safer attachment to the pressure chamber 110, while the reduced thickness of the proximal end 152 enables easier adjustment and positioning of the seal 150 by the user (such as by simply rolling or unrolling the seal 150), and a more comfortable abutment against the user's limb.

After placement of the limb, the seal 150 may be rolled in a proximal direction to encompass the limb and seal the pressure chamber 110 from ambient pressure, as shown in fig. 5. The seal 150 preferably has a length sufficient to contact the limb within a predetermined length to provide a strong pressure seal. In one embodiment of the pressure treatment apparatus 100, the seal 150 may be replaced with a different sized seal to fit the anatomy of a different user or limb. The seal 150 may be provided with a trim indication 158 so that the seal 150 may be cut to the size of the user.

In one embodiment, the inflatable cushion 140 may provide additional support and protection to the limb by extending 20mm beyond the pressure chamber 110 in the proximal direction.

As depicted in fig. 1-2 and 6, the pressure chamber 110 may include a support surface 130 at the second end 114. The support surface 130 may include a flat bottom portion 132 and an angled portion 134, and the support surface 130 may be molded as a separate piece secured to the pressure chamber 110. The flat bottom portion 132 allows the pressure chamber 110 to remain stable in a predetermined position so that a user may be comfortably seated during use of the pressure therapy device 100. The angled portion 134 may be present at the front surface 116 and the rear surface 118 such that the pressure chamber 110 may be stably positioned in an inclined position. Angled portion 134 may be curved such that pressure chamber 110 may easily rotate, or may be flat to provide stability in a predetermined position.

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

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

Support surface 130 may include modular space 180 for receiving one or more modular components. In one embodiment, the modular components may be replaceable, and the modular components may include vibrating components, heating components, cooling components, and the like.

As shown in fig. 4, an adjuster 128 may be engaged with the first locking element 126 to allow manipulation of the pressure chamber 110 from a remote location (e.g., from a seated position). The pressure chamber 110 may then be lifted or rotated to allow the limb to pass through the opening 120 without any flexion or rotation of the limb.

The positioning mechanism 172 may indicate to the user that the limb is properly positioned within the pressure chamber 110 so that the limb is comfortably held without contacting the walls or surfaces of the pressure chamber 110. The positioning mechanism 172, together with the rolled back seal 150, the adjuster 128, the third locking element 162, and the corresponding receiving element 138, allow for easy and accurate placement of the limb within the pressure chamber 110.

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

In one embodiment, the positioning mechanism 172 may have a shape that corresponds to the arch of the foot, as shown in fig. 17, 18, and 28, and the positioning mechanism 172 may provide a slight positive pressure massage to the foot, which increases the comfort and blood flow of the user. In one example, the medial and lateral sides of the positioning mechanism may have different heights and angles to more comfortably secure the user's limb in a preferred position. The positioning mechanism 172 may be provided with a hollow space, such as for accommodating flexibility of the positioning mechanism under the limb and/or for receiving a dampness removing element 174. For example, the dampness removing element 174 may comprise a silica pack.

In one embodiment, the positioning mechanism 172 may also provide slight pressure during the negative pressure cycle to force blood from the vascular bed under the feet up to the heart. During the oscillating pressure cycle, a slight massage effect will be experienced under the foot.

The positioning mechanism 172 may be configured with a predetermined shape, such as a narrow arch having a predetermined height, designed to avoid pressure under the toes, forefoot, and heel where ulcers are typically located. Any remaining suction of the limb not compensated by the inflatable cushion 140 will only cause the foot to flex upwards (toe up) while the heel will move slightly downwards without contacting the bottom of the pressure chamber 110.

To provide the described massage effect without allowing the limb to contact the bottom of the pressure chamber 110, the positioning mechanism 170 may comprise a slightly elastic bow, such as one having a height of 7cm to 10 cm. The positioning mechanism may comprise polyurethane, or other slightly resilient material as follows: these materials are strong enough to prevent the user's limb from collapsing the positioning mechanism and contacting the pressure chamber, while also being slightly resilient to increase the massaging effect on the limb and provide a comfortable rest. The positioning mechanism may have a hardness of 30 shore a to 50 shore a, in particular 45 shore a.

The positioning mechanism 172 may be retractable such that after contact with the limb, the positioning mechanism 172 collapses or retracts to ensure the limb is positioned freely within the chamber, as shown in fig. 16. In another embodiment, the positioning mechanism 172 may be configured to provide support to the limb of the user throughout the operation of the pressure treatment device 100.

Preferably, the limb may be positioned in the pressure chamber 110 without contacting the pressure chamber 110, as shown in fig. 6. The wide opening 120 and the short "neck" or receiving area 122 combine to facilitate limb access so that the pressure chamber 110 can be manipulated to "wear" onto the limb of the user by advantageously using the adjustment member 128 and the angled portion 134 of the support surface until the limb contacts the positioning mechanism 172. Positioning the limb in this manner enables the user to position the limb without significant effort or difficulty and ensures that a large portion of the limb is exposed to pressure treatment while preventing pressure points or skin damage.

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 conventional boots, the pressure chamber 110 has streamlined features, including a wide opening, a short neck, and a ramped front portion. Pressure chamber 110 may advantageously be worn on the user's foot without bending or rolling the ankle or other joint, which may be difficult or painful for the user.

The pressure chamber 110 may be configured to be assembled or enclosed around a limb. While pressure chambers 110 configured to be assembled or enclosed around a limb provide the same advantages of limited flexion or rotation of the limb, implementation is more difficult and manufacturing and sealing of pressure chambers 110 is more complex. Preferably, the limb is inserted using a pressure chamber 110 having a preferably wide opening 120 and a short receiving area 122.

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, such as a resting position. The stabilizing structure 170 may support the limb of the user in a reclined position to provide comfort during use, or may assist the user in initially positioning the limb within the pressure chamber 110. Preferably, the stabilizing structure 170 is adjustable to different lengths and positions.

Although shown as a single straight piece in fig. 6 and 10, the stabilizing structure 170 may be curved, may include multiple pieces, may be split in a fishtail configuration, and may be telescoping within the pressure chamber 110 or separate from the pressure chamber 110. In one embodiment, the stabilizing structure 170 may include at least one resilient bow extending from the pressure chamber 110, and the stabilizing structure 170 may also be adjustable to different positions or curvatures. The stabilizing structure 170 facilitates use and positioning of the pressure treatment apparatus 100 by a user and helps avoid pressure points or discomfort by assisting the pressure treatment apparatus 100 to be properly supported.

As shown in fig. 24, the pressure chamber 110 may be provided with a stabilizing structure 170, a positioning mechanism 172, and an adjuster 128.

As shown in fig. 1, the pressure chamber 110 is configured such that a front side 116 and a rear side 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 may be configured to be predominantly straight to facilitate passage of the limb through the opening 120 and receiving space without bending or rotating the limb. In some embodiments, the rear side 118 of the pressure chamber 110 may extend beyond the extension of the front side 116.

The pressure region of the pressure chamber 110 may be in communication with a pump unit 190 using a conduit 188 located at the rear side 118 of the pressure chamber. Embodiments of the apparatus are not limited to a particular location of the conduit 188, so long as the conduit is in communication with the pressure region 124.

As shown in fig. 7 and 19, the piston 200 of the pump unit 190 may include a wing 202 for contacting a cylinder 204. As the piston 200 moves within the cylinder 204, a non-atmospheric pressure is created within the pressure chamber 110. The wings 202 reduce friction between the piston 200 and the cylinder 204, such that the cylinder 204 has a reduced resistance to movement of the piston 200, thereby reducing the mechanical requirements for moving the piston 200 to generate non-atmospheric pressure.

Because the piston 200 is not in direct contact with the cylinder 204, engineering tolerances are increased and the piston 200 and/or cylinder may be manufactured by injection molding, which requires a slight conical shape to allow removal of the molded part from the mold, rather than a "perfect" cylindrical shape. The sides of the molded part may have an angle of inclination of 0.2 degrees, forming a slightly tapered shape.

The prior art methods for creating a piston 200 without the described wings 202 generally 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 each be produced as a single injection molded part, thereby reducing material costs and required manufacturing accuracy. This is particularly advantageous because of the following: the cost of producing parts requiring precise consistency; by using the wings 202, the tolerances for the different sized components are increased, which simplifies the cost and complexity of the manufacturing process, reducing the cost of the piston 200 and cylinder 204.

In one embodiment, the wings 202 may comprise an elastic material to adjust to the size of the piston 200 and cylinder 204. The use of resilient wings 202 allows the piston 200 to adjust to varying sizes of the cylinder 204. The adjustable nature of the piston 200 and the resilient wings 202 allows for the manufacture of low cost cylinders 204, particularly molded cylinders, where the first end of the cylinder may have a larger diameter than the second end. In one embodiment, the first end of the cylinder 204 may form an angle of up to 3 degrees with the second end. The resilient wings 202 are configured to have a length and resiliency sufficient to seal the cylinder 204 along the entire length of the cylinder 204.

Referring to fig. 8, a first valve system 210 is depicted, the first valve system 210 being used to turn on and off communication between the pressure region 124 and ambient atmospheric pressure. The first valve system 210 may include a closed passage 212 in communication with the pressure region 124 and ambient atmospheric pressure. As depicted, the channel 212 may include an elastomeric cap 216 on the ambient atmospheric pressure side and a chamfered gasket 214 on the pressure zone side, the elastomeric cap 216 and the chamfered gasket 214 together defining a central opening 218 that is wider at the chamfered gasket 214 than at the elastomeric cap 216. A sealing unit 220 is disposed within the channel 212 on the pressure zone side of the chamfer washer 214.

According to one embodiment, the sealing unit 220 may comprise a ball having a size configured to close the central opening 218 by making contact with the chamfered gasket 214 and the elastic cap 216. Because the elastomeric cover 216 contacts the sealing unit 220, engineering tolerances of the sealing unit 220 are increased and sealing to the central opening 218 is improved.

When a negative pressure is created within the pressure region 124, the sealing unit 220 maintains the central opening 218 closed until a predetermined pressure is reached that causes the sealing unit 220 to lift from the central opening 218 and allows communication between the pressure region 124 and the ambient atmospheric pressure. The pressure area 124 may be configured to have a maximum safe pressure by adjusting the mass of the sealing unit 220, the elasticity of the elastic cap 216, and the size of the central opening 218. In a preferred embodiment, the sealing unit 220 is removed from the central opening 218 at a pressure of 60mmHg to 150mmHg, more particularly at a pressure of 60mmHg to 75 mmHg.

The chamfered gasket 214 may include additional openings 215 positioned at the sides of the chamfered gasket 214 for opening the resilient cover 216 in response to an overpressure. The first valve system 210 operates as a relief valve.

The elastomeric cover 216 may be pre-stretched and secured within the channel 212 by the chamfered gasket 214 and the walls of the channel 212. As depicted in fig. 8, the resilient cover 216 is fixed in place and cannot move or be 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, the 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 is in communication with the ambient pressure and the internal pressure of the pressure chamber may be adjusted to the ambient pressure.

The preferred method of use of the pressure treatment apparatus 100 is to apply pressure treatment to a limb of a user. Pressure therapy may include applying a pulsating pressure during successive time periods or repeatedly, alternately introducing two or more different pressures. In one example, the pulsating pressure may include alternately introducing the applied pressure and releasing the applied pressure to return to near atmospheric pressure. The applied pressure may be a positive pressure, or a negative pressure. In embodiments that use negative pressure, the period during which negative pressure is introduced and present is a negative pressure period. Likewise, in systems utilizing positive pressure, the period during which positive pressure is introduced and present is the positive pressure period. In each case, the period in which the applied pressure is released and returned to atmospheric pressure and atmospheric pressure is present is an atmospheric pressure period.

The embodiments discussed herein are discussed with reference to negative pressure being applied. In general, the negative pressure system can be easily replaced with a positive pressure system by reversing the pump and valve operation or by other adjustments as would be apparent to one of ordinary skill in the art. It should be appreciated that any discussion of negative pressure systems applies equally to positive pressure systems, unless otherwise noted. In this case, the term "negative pressure" as used herein should be replaced with the term "positive pressure", and the pressure values should be replaced as such. The present disclosure should not be construed to exclude apparatus and methods that use positive pressure rather than negative pressure.

In some embodiments, multiple, consecutive, alternating periods of negative pressure and atmospheric pressure are applied to the limb within the pressure chamber without removing the limb from the chamber. The negative pressure period and the atmospheric pressure period may have the same duration, or have different durations. In some embodiments, the negative pressure period and the atmospheric pressure period may be selected according to known methods, such as those described in commonly owned U.S. patent application publication No.2005/0027218, published on 3/2/2005.

In some embodiments, the negative pressure period is between 1 and 20 seconds in duration, and the atmospheric pressure period is between 2 and 15 seconds in duration. Further, in some embodiments, the negative pressure period is between 5 seconds and 15 seconds in duration, and the atmospheric pressure period is between 5 seconds and 10 seconds in duration. Also, in some preferred embodiments, the duration of the negative pressure period is about 10 seconds, and the duration of the atmospheric pressure period is about 7 seconds.

The pressure applied within the pressure chamber may be fixed or selected at the point of use. Embodiments of the apparatus and methods according to the present disclosure provide for applying a negative pressure of-150 mmHg or less, more particularly-80 mmHg (-10.7kPa) or less. The corresponding pressure chamber is configured to withstand a negative pressure of at least-80 mmHg (-10.7kPa), and preferably to withstand even much greater negative pressures. In some embodiments, the negative pressure may be-60 mmHg (-8.0kPa) or less. Some embodiments utilize a negative pressure of about-40 mmHg (-5.3 kPa). The preferred negative pressure has been selected to reduce complications that may result from applying a higher negative pressure. In some embodiments, the negative pressure has been selected to promote local vasodilation of the surface of the limb, while minimizing the risk of possible complications. It has been found that pulsing the negative pressure can facilitate blood flow, and preferably produces a pulsed negative pressure in the pressure chamber of 0mmHg to-40 mmHg (0kPa to-5.3 kPa).

According to the embodiment of the device in fig. 20 and 27, the inflatable cushion 140 is configured with a valve 192, preferably a one-way or non-return valve, to provide communication with ambient atmospheric pressure. Valve 192 may be positioned to extend through a side of pressure chamber 110 that secures protrusion 242, around an opening in the pneumatic seal and extending through an opening in pressure chamber 110.

In such an embodiment, inflatable cushion 140 is inflated by applying a negative pressure within pressure chamber 110, and does not require the use of any additional vacuum or pressure generating mechanism. Advantageously, when the inflatable cushion 140 is provided with a valve 192, the inflatable cushion 140 will inflate in response to negative pressure and secure the limb in a predetermined position within the pressure chamber 110. In the case where the inflatable cushion 140 is provided with a plurality of chambers, each chamber is provided with a valve or a three-way valve for independently inflating and deflating.

The lever arm 222 may be positioned to displace the sealing unit 220 during periods of atmospheric pressure and retract the sealing unit 220 during periods of negative pressure. According to one embodiment of the pressure treatment apparatus 100, the lever arm 222 may be fixed to the motor of the pump unit 190 such that when the motor is activated to drive the piston 200 and generate a non-atmospheric pressure, the torque of the motor moves the lever arm 222 away from the central opening 218 and displaces the sealing unit 220 only when the motor is not in use.

At the end of the negative pressure period and during the period of atmospheric pressure within the pressure chamber 110, the inflatable cushion 140 may provide an overpressure against the limb of the user. The overpressure is caused by pressure variations within the pressure chamber 110 that cannot be accommodated by the inflatable cushion 140 due to the closing of the valve 192. An overpressure against the user's limb may result in a positive pressure of about 10mmHg being applied against the user's limb during the period of atmospheric pressure, further increasing the flow of blood through the user's limb by direct mechanical force.

The inflatable cushion 140 may be constructed with a greater thickness or a lesser thickness of material to regulate and control the magnitude of the overpressure applied to the limb. The inflatable cushion 140 may have a variable thickness to distribute pressure or overpressure unevenly to the limb. The areas of greater thickness may be arranged to contact areas requiring less pressure or compaction, while the areas of lesser thickness may be arranged to contact areas requiring more pressure. The thickness may also be set based on desired heat transfer characteristics or comfort requirements.

When in use, the inflatable cushion 140 inflates during periods of negative pressure and secures the limb of the user within the pressure chamber 110. To enable the user to remove the limb after use, the inflatable cushion 140 is adapted to deflate to release the pressure generated during the negative pressure period of the pressure therapy device 100.

To deflate the inflatable cushion 140 and enlarge the opening of the pressure chamber 110 for insertion or removal from the user's limb, the valve 192 may include a lever actuated valve 194, a timed valve 196, or a manually actuated valve (not shown). According to fig. 21, a rod actuation valve 194 may be provided on the exterior of the pressure chamber 110 such that the seal 150 in the rolled back position actuates the rod and opens the valve 192. When the seal 150 rolls up on the user's limb, the valve 192 returns to the closed position and may inflate in response to a negative pressure. According to fig. 22, a timing valve 196 may be provided on the exterior of pressure chamber 110 such that a user may actuate the valve by depressing a switch 198.

As shown in fig. 23, the switch 198 actuates the valve 192 in a depressed position but connected to the spring 206 and rotational damper 208, causing the switch 198 to slowly return to its original position and close the valve 192. The spring 206 and rotational damper 208 may be configured to actuate the valve 192 for a predetermined amount of time such that the predetermined amount of time will cause the inflatable cushion 140 to deflate and move out of the user's limb. In a manually actuated valve, a button may be provided that a user may depress to actuate the valve 192. The valve remains open only for the period of time that the user depresses the button. In embodiments having, for example, a three-way valve, valve 192 may also be connected to pump unit 190 to deflate inflatable cushion 140 in a rapid manner.

By providing a medical pressure treatment device according to an embodiment of the present disclosure, the following problems are solved: pressure treatment devices are difficult to customize for an individual user, pressure treatment techniques are limited, users with limited dexterity or strength are difficult to wear, discomfort due to pressure points and contact between the pressure chamber and a wound or ulcer on the user's limb, and hazards due to the accumulation of unhealthy durations or levels of non-atmospheric pressure. The pressure therapy device of the present disclosure advantageously allows a user to intuitively and accurately wear the device without the assistance of a clinician. Thanks to the operation of the seal and the inflatable cushion, the device conforms to the size of the user and prevents the device from contacting a wound on the surface of the user's limb. The device also has a unique valve arrangement that automatically mitigates harmful pressure levels or durations while providing a favorable negative pressure profile around the limb and an intermittent massage effect.

Case studies have been employed to demonstrate the efficacy of pressure treatment devices according to the present disclosure, and positive initial results have been produced.

In one such study, the effect of different pressure levels on the user's limb was analyzed by treating a sample population of 16 individuals with peripheral arterial disease with the pressure treatment device of the present disclosure. More than 90% of the sample population in the study had mild claudication and was classified as stage II of the fontaine phase of chronic limb ischemia.

Pairwise comparisons were made for the effects of pressure levels of-10 mmHg, -20mmHg, -40mmHg and-60 mmHg on leg and foot flow and laser doppler fluence measurements, and demonstrated statistically significant increases in flow and doppler fluence, as shown in table I below.

TABLE I

As demonstrated, embodiments of the pressure treatment device utilizing a negative pressure of about-40 mmHg (-5.3kPa) demonstrate: blood flow through the limb of a patient suffering from peripheral artery disease is significantly improved and thus healing may be improved.

Another study examined the effect of the pressure treatment device of the present disclosure on individuals with severe lower limb ischemia. These individuals suffer from a number of symptoms including chronic pain and open wounds or ulcers in the lower extremities. In particular, the treatment of individuals who are not suitable for undergoing, or have elected not to undergo, a revascularization procedure (i.e., angioplasty, vascular bypass surgery, or other surgical procedure) is selected.

Initial data from the study showed that: when there is no revascularization option available, the chronic wound tends to worsen with 5/7 size of the original wound in the point-of-care group increasing on average 275% (SD 514%) and two new wounds formed. When using the pressure therapy device of the present disclosure, 6/9 wound healing was observed for the wound present at the beginning of the treatment, with an average reduction in wound size of 19% (SD 78%).

In addition to changes in wound size, changes in the care and management of wounds are seen. The number of dressing changes per week was varied in the control group to manage an increase in wounds from an average of 1.67 to 3.67, while a reduction in the number of dressing changes from 2.75 to 1.75 times per week was observed in the group treated with the pressure treatment device of the present disclosure. This demonstrates the potential cost savings advantage of the pressure therapy apparatus of the present disclosure over prior art methods, as each wound change requires the physical cost of each change and assistance from a specialized vascular nurse or podiatrist.

The participants' foot pain was recorded on a visual analog scale, where 0 represents no pain and 100 represents the most severe pain that was imaginable. Foot pain increased slightly from 46 to 58 in the control group, but foot pain was shown to decrease from 48.75 to 45.25 in the group treated with the pressure treatment device of the present disclosure. Pain management with drugs also showed differences between the two groups, the treatment group and the control group, with a reduction in opioid analgesics in the treatment group relative to the control group.

The above case studies clearly demonstrate the advantages 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. It appears that similar advantages have not been achieved by the prior art.

As will be readily apparent from the foregoing discussion, it will be appreciated that the size, number, configuration, and location of the medical pressure treatment device and its components may be adjusted, and thus many different users having different sized joints and body parts may benefit from the present design without the need for customized manufacturing and design. It should also be understood that the arrangement of the inflatable cushion, seals, positioning mechanism and other components may be substituted according to those shown to facilitate users having different sizes and pathologies.

Claims (36)

1. A pressure therapy device (100), the pressure therapy device (100) comprising:

a pressure chamber (110) having a first end (112) and a second end (114), the first end (112) defining an opening (120);

an inflatable cushion (140) positioned in the opening (120) and including a valve (192) in communication with ambient pressure;

a seal (150) secured to the first end (112) of the pressure chamber (110) for sealing the opening (120); and

a pump unit (190) connected to the pressure chamber (110) and configured to generate a negative pressure within the pressure chamber (110);

wherein the inflatable cushion (140) is configured to: inflating in response to the negative pressure being generated within the pressure chamber by the pump unit (190) to narrow the opening (120) and fixate around a limb of a user.

2. The pressure therapy device (100) of claim 1, wherein the inflatable cushion (140) is configured to: when the generation of the negative pressure by the pump unit (190) is finished, the inflatable cushion is inflated due to the overpressure.

3. The pressure therapy device (100) according to any one of the preceding claims, wherein the inflatable cushion (140) comprises at least an anterior air chamber and a posterior air chamber, the posterior air chamber having a longer length than the anterior air chamber of the inflatable cushion (140).

4. Pressure therapy device (100) according to any one of the preceding claims, wherein the pump unit (190) comprises a first valve system (210) comprising a chamfered gasket (214) and a resilient cover (216) defining a central opening (218) in a channel (212), wherein a sealing unit (220) is positioned on the chamfered gasket (214) for closing the central opening (218).

5. The pressure therapy device (100) according to any one of the preceding claims, wherein the seal (150) comprises a frusto-conical sleeve having a first end (152) and a second end (154), a central axis of the first end (152) of the frusto-conical sleeve being eccentric with respect to a central axis of the second end (154) of the frusto-conical sleeve.

6. Pressure therapy device (100) according to any of the preceding claims, wherein the pump unit (190) comprises a piston (200) and a cylinder (204), the piston (200) comprising a wing (202) extending from the piston (200) to the cylinder (204).

7. Pressure therapy device (100) according to any of the preceding claims, wherein an outer surface of the pressure chamber (110) is provided with a first locking element (126) for fixing to an adjustment member (128).

8. Pressure therapy device (100) according to any of the preceding claims, wherein the second end of the pressure chamber (114) comprises a support surface (130) having a flat portion (132) and an angled portion (134).

9. The pressure therapy apparatus (100) of claim 8, wherein an interior of the support surface (130) includes a positioning mechanism (172) for receiving a foot of the limb.

10. The pressure therapy apparatus (100) of claim 9, wherein the positioning mechanism (172) includes a narrow arcuate shape corresponding to an arch of the foot.

11. Pressure therapy device (100) according to any of the preceding claims, wherein the first end (112) of the pressure chamber (110) is provided with at least one second locking element (136) for fixing to the inflatable cushion (140) on an outer surface of the pressure chamber (110).

12. Pressure therapy device (100) according to any of the preceding claims, wherein the pressure chamber (110) is provided with an adjustable stabilizing structure (170) extending from the second end (114) of the pressure chamber.

13. Pressure therapy device (100) according to any of the preceding claims, wherein the second end (114) of the pressure chamber (110) comprises a support surface (130) having a modular space (182) configured for receiving a plurality of modular components (180).

14. The pressure therapy device (100) of claim 13, wherein the plurality of modular components (180) comprises a heating unit, a cooling unit, a vibration unit, and/or an electrical stimulation unit.

15. Pressure therapy device (100) according to any of the preceding claims, wherein the pressure chamber is provided with a conduit (188) communicating with the pump unit (190).

16. Pressure therapy device (100) according to any of the preceding claims, wherein an outer front surface and an outer rear surface of the pressure chamber (110) form an angle such that a distance between the outer front surface and the outer rear surface increases along a height of the pressure chamber (110) towards the second end (114) of the pressure chamber (110).

17. Pressure therapy device (100) according to any of the preceding claims, wherein the outer front surface is configured to be straight and to extend at a constant angle from the opening (120) of the pressure chamber (110).

18. The pressure therapy device (100) according to any one of the preceding claims, wherein the inflatable cushion (140) extends beyond the first end (112) of the pressure chamber (110) by a distance of 5mm to 20 mm.

19. Pressure therapy device (100) according to any of the preceding claims, wherein the seal (150) comprises a first end (152) and a second end (154), the second end (154) of the seal having at least one protrusion (156) for fixing the second end (154) of the seal to the first end (152) of the seal in a stretched configuration.

20. Pressure therapy device (100) according to any of the preceding claims, wherein the seal (150) comprises a first end (152) and a second end (154), the first end (152) of the seal having a thickness that is thicker than the thickness of the second end (154) of the seal.

21. Pressure therapy device (100) according to any of the preceding claims, wherein the seal (150) comprises thermo-compression silicon, TPE or TBE.

22. Pressure therapy device (100) according to any of the preceding claims, wherein the seal (150) has a thickness of 1-2 mm.

23. Pressure therapy device (100) according to any one of the preceding claims, wherein the seal (150) comprises a material having a shore a number in the range of 0-15.

24. The pressure therapy apparatus (100) of claim 23, wherein the seal (150) comprises a material having a shore a number of 5.

25. Pressure therapy device (100) according to any of the preceding claims, wherein the valve (192) comprises a stem (194) for opening the valve to ambient pressure.

26. Pressure therapy device (100) according to claim 6, wherein the wing (202) of the piston (200) comprises an elastic material.

27. The pressure therapy apparatus (100) of claim 6, wherein the wings (202) of the piston (200) are configured to flex in response to a pressure of 20-150 mmHg.

28. Pressure treatment device according to claim 4, wherein the sealing unit (220) is configured to have a predetermined mass such that the sealing unit (220) is removed from the central opening (218) at a pressure of 20-150 mmHg.

29. Pressure therapy apparatus according to claim 4, wherein the sealing unit (220) comprises a steel ball.

30. The pressure therapy apparatus according to claim 4, wherein the first valve system (210) is provided with a lever arm (222) configured to: the lever arm displaces the sealing unit (220) when the pump unit (190) is operated to generate a non-atmospheric pressure.

31. The pressure therapy apparatus of claim 4, wherein the chamfer washer (214) is configured to define an additional opening (215) therethrough.

32. Pressure therapy device according to claim 32, wherein the elastic cover (216) is configured as a valve located on the additional opening (215).

33. A method of using a pressure therapy device (100), the method comprising:

obtaining a pressure chamber (110) having a first end (112) and a second end (114), the first end (112) defining an opening (120);

providing an inflatable cushion (140) located in the opening (120) of the pressure chamber (110), the inflatable cushion comprising a valve (192) in communication with ambient pressure;

providing a seal (150) secured to the first end (112) of the pressure chamber (110) for sealing the opening (120) and surrounding the inflatable cushion (140), the seal (150) being in an open configuration;

inserting a limb through the seal (150), the inflatable cushion (140), and the opening (120) of the pressure chamber (110);

closing the seal (150) around the limb in the opening (120); and

creating a negative pressure in the pressure chamber (110) to inflate the inflatable cushion (140) and secure the limb in the opening (120).

34. The method of claim 34, wherein the method further comprises:

releasing the negative pressure in the pressure chamber (110) and creating an overpressure in the inflatable cushion (140) for massaging the limb.

35. The method of claim 34, wherein the inflatable cushion (140) is provided with at least two air chambers.

36. The method of claim 36, wherein the method further comprises:

actuating a lever mechanism (194) of the valve to deflate the inflatable cushion (140).

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