Patent Application
20210275386
The subject invention is directed generally to a device for applying compression to a limb, and more particularly, to a therapeutic apparatus for applying compression to the leg of an individual in conjunction with the treatment of conditions such as chronic venous insufficiency and lymphedema. The apparatus includes a wrap having a bladder and an inflation means for the bladder with the apparatus capable of applying compression to a limb such as the lower leg and foot of a patient.
Normally, a healthy leg muscle, for example, squeezes the deep veins of the legs and feet to help move blood back to the heart. One-way valves in the deep leg veins keep blood flowing back towards the heart. However, prolonged periods of standing or sitting can cause the walls of the deep leg veins to stretch. Over time, in susceptible individuals, this can weaken the vein walls and damage the valves, causing blood to pool in the veins and increase venous blood pressure. This may result in a condition known as chronic venous insufficiency (CVI).
Treatment of CVI typically involves the use of compression stockings or medical hosiery to decrease chronic swelling. Compression stockings are elastic stockings that squeeze the veins to improve venous circulation and prevent excess blood from flowing backward. Compression stockings can also help to heal skin sores or stasis ulcers that often present in conjunction with CVI. It is also common to employ compression bandages to apply pressure to the leg. In this regard, a bandage is applied with constant tension so as to produce graduated compression with the highest pressure at the ankle. However, the technique is difficult and is often done by highly skilled caregivers.
Highly effective mechanical compression devices have also been developed for treating CVI, which are disclosed, for example, in U.S. Pat. Nos. 7,276,037 and 7,559,908, the disclosures of which are incorporated by reference herein in their entireties. These devices include a flexible wrap that carries a manually inflatable air bladder and is adapted to be securely positioned around the leg of an individual to apply localized pressure to a treatment site. The device also includes a fluid-filled wound dressing that can be applied directly to the skin for applying localized pressure and even a medicament to a venous ulcer when it is enveloped by the flexible wrap. While this device is effective for applying localized compression to the leg, it is not configured to apply localized compression to the foot to prevent swelling and further improve venous circulation.
Lymphedema, also known as lymphatic obstruction, is another condition of localized fluid retention and tissue swelling, and is caused by a compromised lymphatic system. Treatment for lymphedema varies depending on the severity of the edema and the degree of fibrosis of the affected limb. The most common treatments for lymphedema are manual compression lymphatic massage, compression garments or bandaging. Elastic compression garments are typically worn by persons with lymphedema on the affected limb following complete decongestive therapy to maintain edema reduction.
Compression bandaging, also called wrapping, involves the application of several layers of padding and short-stretch bandages to the involved areas. Short-stretch bandages are preferred over long-stretch bandages (such as those normally used to treat sprains), as the long-stretch bandages cannot produce the proper therapeutic tension necessary to safely reduce lymphedema and may in fact end up producing a tourniquet effect. During activity, whether exercise or daily activities, the short-stretch bandages enhance the pumping action of the lymph vessels by providing increased resistance for them to push against. This encourages lymphatic flow and helps to soften fluid-swollen areas.
Known methods for CVI and lymphedema treatment, like compression bandaging, have several disadvantages. The bandaging is time consuming and the effectiveness is limited to the skill of the provider. In some instances, bandages can be applied too tightly or too loosely and may slip from their intended position, decreasing their effectiveness. When this occurs, bandages must be taken off and reapplied, further increasing the time of application and decreasing the consistency of application of the therapy.
The effectiveness of many of the current compression therapies is limited by the application of current products. Because current compression therapy is done either with manual wraps or electromechanical systems, they require either a skilled medical processional to apply and/or the need for the patient to be stationary for extended periods of time. Although stockings and/or bandages can be worn by patients and self-administered, they are very difficult for the patient to put on and pose a challenge for unskilled medical professionals to apply consistently and effectively.
Further, many of the current treatment options for CVI and lymphedema cause venous ulcers including the use of current known devices, apparatus, bandages, stocking, hosiery and the like. A venous ulcer is damage and loss of skin above the ankle that is the result of a problem with the veins in the leg. Venous ulcers typically develop on either side of the lower leg, above the ankle and below the calf. They are difficult to heal and often recur.
The veins of the leg are divided into the superficial and deep systems according to their position relative to the fascia. The deep veins, which come together to form the popliteal and femoral veins lie within the fascia and are responsible for the venous return from the leg muscles. Dilated valveless sinusoids also lie within the fascia (more particularly in the soleus and gastrocnemius muscles). The sinusoids fill with blood when the leg is at rest.
The long saphenous vein which runs along the medial side of the leg from foot to groin and the short saphenous vein which runs at the back of the calf from foot to knee are the major vessels of the superficial venous system. These vessels lie outside the fascia and are responsible for the venous return from the skin and subcutaneous fat.
Communicating veins, sometimes called perforators because they perforate the deep fascia, join the two systems. The perforators, like the other veins in the leg, contain valves that permit the flow of blood in one direction only, from the outer or superficial system inwards to the deep veins.
The venous pressure at the ankle of a subject who is lying supine is around 10 mmHg, but on standing this will rise considerably due to an increase in hydrostatic pressure (equivalent to the weight of a vertical column of blood stretching from the point of measurement to the right auricle of the heart).
During walking, as the foot is dorsally flexed, the contraction of the calf muscle compresses the deep veins and soleal sinuses thereby emptying them of blood. As the foot is plantarly flexed, the pressure in the veins falls, the proximal valves close, and the veins are refilled by blood passing through the perforators from the superficial system. During this cycle, in a normal leg, the distal valves of the deep veins and the valves of the perforators will ensure that the expelled blood can go in only one direction—upwards, back to the heart.
Blockage or damage to the venous system will cause disruption to normal blood flow, which may manifest itself in a number of different ways according to the site and extent of the damage. If the valves in the superficial system are affected, venous return will be impaired and blood may accumulate in the veins causing them to become distended, leading to the formation of varicosities (varicose veins).
If the function of the perforator valves is impaired, the action of the calf muscle pump will tend to cause blood to flow in the reverse direction into the superficial system increasing the possibility of damage to the superficial vessels.
Following a deep vein thrombosis that results in complete or partial obstruction of a deep vein, the unrelieved pressure produced by the calf muscle pump on the perforator valves may cause these to become incompetent. If this occurs, there will be a large rise in the pressure in the superficial system, which may force proteins and red cells out of the capillaries and into the surrounding tissue. Here, the red cells break down releasing a red pigment that causes staining of the skin, an early indicator of possible ulcer formation.
Venous leg ulcers are generally shallow and red in color. The skin surrounding the ulcer is frequently discolored due to the staining described previously. Incompetent perforating vein valves can also cause malleolar venules to become dilated and appear as line red threads around the ankle. This condition, called ankle flair, is also diagnostic of a venous ulcer.
Arteries transport oxygen replenished blood from the heart to the rest of the body. Veins return oxygen depleted blood back to the heart. When the veins in the lower extremities of the body have difficulty transporting blood back to the heart, a condition develops called chronic venous insufficiency (CVI), also known as chronic venous disease (CVD). CVI most commonly occurs as the result of a blood clot in the deep veins of the legs, a disease known as deep vein thrombosis (DVT). CVI also results from pelvic tumors and vascular malformations, and sometimes occurs for unknown reasons. When a person is standing or sitting, blood in the veins of the legs flows in an upward direction. When the person walks, the calf muscles and muscles in the feet contract to squeeze the veins and push the blood upward. To keep the blood flowing upward and prevent it from flowing downward, the veins contain one-way valves. CVI occurs when these valves become damaged and allow the blood to leak back downward in the opposite direction. Such valve damage may occur as the result of aging, extended sitting or standing, or a combination of aging and reduced mobility. When the veins and valves become weakened and the blood does not properly flow up to the heart, blood pressure in the veins of the lower extremities can stay elevated for long periods of time, leading to CVI. This condition is more common in older individuals, and if not properly treated, can lead to burst capillaries, local tissue inflammation, internal tissue damage, varicose veins, ulcers, and open sores on the skin's surface.
CVI can diminish the capacity of the venous system and increase the workload of the lymphatic system in the affected area. The lymphatic system must then transport larger volumes of water and protein to reduce the fluid load in the affected tissues of the legs, a situation which is especially difficult for patients with Lymphedema, varicose veins, and other lower extremity pathology.
One non-surgical option often used to help prevent or treat the lower extremity pathologies discussed above is the use of compression stockings. Compression stockings help prevent leg fatigue, ankle and foot swelling, spider veins, and varicose veins. They improve circulation in the legs, especially when used in conjunction with frequent exercise and leg elevation. Compression stockings maintain pressure on the legs while allowing for normal ambulation. Increasing pressure in the tissues beneath the skin reduces excess leakage of fluid from the capillaries and increases absorption of tissue fluid by the capillaries and lymphatic vessels. In addition, the increased pressure decreases the size of the veins, which causes the blood to flow faster and help prevent it from pooling.
Compression stocking tightness typically varies between 15-50 mm HG. The tightness of a given stocking depends on its particular configuration and class. For example, stockings having a compression pressure of 15-20 mm HG are considered light compression stockings. Class I stockings are 20-30 mm Hg, class II stockings are 30-40 mm Hg, and class III stockings are 40-50 mm Hg.
While such compression stockings are a commonly utilized non-invasive treatment of lower leg pathology, the issues they present are numerous. Wearing a tightly fitting stocking can be tedious or time consuming to put on, and may require help from another person if the wearer is injured, elderly, or has some form of disability. In addition, the pressure applied by the stocking generally stays relatively constant during use without any option of increasing or decreasing the tightness level. As compression stockings are repeatedly worn, they lose elasticity and thus tightness over time. Once such prescribed elasticity and tightness is lost, the socking is of little or no value, and needs to be replaced on account of its looseness, which requires buying a new pair to obtain the desired pressure.
Medical hosiery represents a useful and convenient method of applying compression to normal shaped legs in order to prevent the development or recurrence of leg ulcers. However, these stockings are of limited value in the treatment of active ulceration, being difficult to apply over dressings. In such situations compression bandages currently represent the treatment of choice. Compression bandages apply a pressure to the limb that is directly proportional to bandage tension but inversely proportional to the radius of curvature of the limb to which it is applied. This means, therefore, that a bandage applied with constant tension to a limb of normal proportions will automatically produce graduated compression with the highest pressure at the ankle. This pressure will gradually reduce up the leg as the circumference increases.
As can be readily appreciated, it is cumbersome and difficult to apply uniform tension to the compression bandage as it is applied to the treated limb, and thus this is accomplished only by highly skilled caregivers. Moreover, once secured to the treated limb, care and attention must be given to ensure that the bandage does not slip or become displaced as this will lead to multiple layers forming, which in turn may lead to localized areas of high pressure, which can place the patient in direct risk of skin necrosis.
Mechanical compression treatments have also been proposed. An exemplary compression device is described in U.S. Pat. No. 5,031,604 to Dye. As generally described at col. 2, lines 33 et seq., an arrangement of chambers are provided that circumscribe the leg. An active pneumatic control system controls the pressure in the chambers to squeeze the leg near the ankle and then squeeze sequentially upward toward the knee in order to move blood from the extremity toward the heart. As noted in col. 4, lines 20-59 of U.S. Pat. No. 6,488,643 to Tumey et al., the mechanically produced compression levels may produce ischaemic (i.e., localized tissue anemia) not noted at similar compression levels obtained through bandaging. It may also produce cuffing (i.e., a reduction in leg pulsatile blood flow). The pneumatic control system is also bulky and heavy, which severely limits the mobility of the patient during treatment. Moreover, the pneumatic control system fails to provide a mechanism to ensure that excessive pressure, which can cause necrosis, is not applied to the treated limb. These limitations have resulted in most mechanical compression devices being contraindicated for patients exhibiting deep-vein thrombosis. Consequently, those skilled in the art have to date avoided such mechanical compression devices for the treatment of venous ulcers or edema of the extremities.
Co-owned U.S. Publication No. 2004/0193084, which is hereby incorporated by reference herein in its entirety, discloses a device for applying pressure to the human leg for use in conjunction with treatment of varicose veins. The device includes a flexible member and at least one air bladder chamber integral thereto that are adapted to securely wrap around the human leg. A tube in fluid communication with the air bladder chamber(s) extends to an air pumping mechanism that operates to inflate the air bladder chamber(s) to a pressurized state. The flexible member preferably includes an opening at the knee joint level to enable a patella to protrude therethrough. In addition, the flexible member preferably extends below knee joint level and is adapted to securely wrap around a lower portion of a leg to provide stability to the leg. Preferably, the air bladder chamber of the device is substantially longer in a first dimension than in a second dimension orthogonal thereto such that the air bladder chamber can be positioned to cover a portion of the human leg that is relatively long in the vertical dimension and narrow in the horizontal dimension.
Co-owned U.S. Pat. No. 7,276,037, which is hereby incorporated by reference herein in its entirety, discloses an apparatus for applying compression therapy to an extremity of the human body, such as a portion of the human leg. The device includes a flexible member and an air bladder chamber. The flexible member is adapted to wrap around the extremity to secure the air bladder chamber to the extremity. An air pumping mechanism is operated to inflate the air bladder chamber to a pressurized state. One or more fluid-filled pressurized members are provided, each separate and distinct from the flexible member and the air bladder chamber and thus readily moveable relative to the flexible member and the air bladder chamber. The pressurized member(s) is operably disposed between the extremity and the flexible member whereby it applies increased localized pressure to the extremity during use. Preferably, the air bladder chamber is substantially longer in a first dimension than in a second dimension orthogonal thereto such that it can extend longitudinally along the extremity to cover a relatively long and narrow portion of the extremity. The position of the air chamber can be readily adapted to apply local pressure to desired body parts (such as a certain venous channel). The pressurized member(s) can be positioned during use such that it covers a venous ulcer (or other treatment sites) and applies increased localized pressure to the treatment site in order to promote healing.
All current known treatment apparatus, devices, bandages, stockings and hosiery have the problems of stability, maintaining sufficient effective pressure without overpressure complications, maintaining compression and the like. Further all known apparatus, devices, bandages, stockings and hosiery, though especially the current treatment apparatus and devices, are only capable of connecting to one source of compression or inflation means and no universal inflation port of connector is known—wherein a patient could vary treatment through varying the inflation source and inflation means for the treatment apparatus or device.
Other known problems with the current treatment apparatus and devices, bandages, stockings and hosiery is the requirement that a skilled care-giver apply the current treatment apparatus and devices, bandages, stockings and hosiery. Such a skilled care-giver may not be available to all patients, notably those without long-term care insurance or provided a skilled home-health aid. Yet another known problem is leakage of set compression within the treatment apparatus and devices, bandages, stockings and hosiery resulting in an ineffective treatment and ineffective apparatus or device and the like which may be rendered useless to the patient and user. A further problem with the current treatment apparatus and devices, bandages, stockings and hosiery is that the inflation means or source of compression is set up as either manual or mechanical or electrical and cannot be interchanged in that the inflation port or inflation means is not universal and interchangeable. Yet another problem with the current treatment apparatus and devices, bandages, stockings and hosiery is that the inflation means or source is either static or intermittent and again cannot be changed during the treatment with such apparatus or device.
The apparatuses, methods, assemblies and systems of the subject invention provide benefits and advantages that may overcome a number of problems with respect to known compression technologies, particularly the problems that arise due to the difficulty of applying current compression wrap technologies. The subject invention provides an alternative to known technologies that employ tight-fitting therapeutic elastic garments, which cause patients discomfort, and lose their elasticity and therefore their effectiveness over time. Those skilled in the art will readily appreciate that it would be beneficial to provide a therapeutic compression device for treating CVI, DVT and lymphedema that is adapted and configured to apply localized compression to the leg and foot to prevent swelling and further improve venous circulation, that may also be self-administered by a patient effectively.
The subject invention is directed to a therapeutic compression apparatus. The therapeutic compression apparatus comprises: a primary wrap and a secondary wrap and optionally a stirrup. The primary wrap encircles at least a first portion of a limb such as a leg and applies compression thereto. The primary wrap has a horizontal proximal edge for positioning towards for instance a knee of the leg, a horizontal distal edge for positioning towards for instance an ankle of the leg, and first and second peripheral edges perpendicular to the horizontal proximal edge and the horizontal distal edge. The secondary wrap encircles at least a portion of a limb such as a foot of the leg to apply compression thereto. The stirrup is integrated with the primary wrap along the horizontal distal edges for securing the primary wrap to the limb such as a leg, the stirrup being positioned between the primary wrap and the secondary wrap.
The therapeutic compression apparatus may further comprise at least one bladder operatively associated with the primary wrap for applying pressure to a treatment site on the limb such as a leg. The primary wrap may include at least one interior pocket for accommodating the at least one bladder. Alternatively, the at least one bladder may be integral with the primary wrap. One or more means for attaching the primary wrap may be operatively associated along the first and second peripheral edges of the primary wrap for securing the primary wrap around the limb.
The at least one bladder may be adapted and configured to form a predetermined gradient pressure profile when the at least one bladder is filled. The at least one bladder may be one of a wedge-shaped bladder, a cone-shaped bladder, a disk-shaped bladder or a rectangular-shaped bladder. The at least one bladder may also include a plurality of fluid chambers. The therapeutic compression apparatus may further comprise at least one means for adjusting pressure coupled to the at least one bladder for controlling an amount of pressure supplied to the treatment site by the primary wrap.
The secondary wrap may be attached to the stirrup. The secondary wrap may be configured to envelope a limb such as the toes of the foot and/or configured to envelope a heel of the foot. The secondary wrap may also be configured as an adjustable strap around the foot.
The therapeutic compression apparatus may further comprises an adjustable belt along a proximal horizontal edge of the primary wrap for securing the primary wrap around the limb such as for instance the leg. The primary wrap may be formed at least in part of a non-elastic composite material comprising a plurality of distinct layers. In one embodiment, the composite material may comprises three distinct layers: an inner laminate layer, an outer hook-compatible layer, and a middle non-elastic layer provided between the inner and outer layers. The composite material may also be provided with a plurality of stitched darts and gathers for contouring the primary wrap to the limb such as for instance the leg.
The subject invention is also directed to a bladder assembly for a compression apparatus for providing pressure to a limb. The bladder assembly comprises: at least one bladder having first and second flexible walls secured to one another about a peripheral edge thereof to form an air pocket; and at least one spot weld provided in a predetermined location inward of the peripheral edge connecting the first and second walls to one another to define a plurality of chambers within the bladder. The geometric placement of the at least one spot weld determines a pressure profile of the at least one bladder.
An inflation means for inflating the bladder such as the air pocket, through at least one inflation port may be provided in the first wall of the bladder assembly. The inflation means may be detachable from the at least one inflation port. At least one pressure valve may be operatively associated with the inflation means for controlling an amount of pressure within the bladder and the air pocket within the bladder. The inflation port includes a check vale so as to maintain a given pressure within the bladder of the therapeutic compression apparatus. The inflation port may be universal in that it is configured to be capable of connecting to and accepting a plurality of inflation sources and inflation means such as a manual pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, pneumatic pump, negative pressure source and other variations.
A method of the invention includes the therapeutic treatment apparatus used to treat CVI, DVT and/or lymphedema by applying the primary and secondary wraps around a limb by a patient and inserting an inflation means into an inflation port and inflating the bladders within the primary and secondary wraps and maintaining a certain pressure to treat the CVI, DVT and/or lymphedema.
Another embodiment of the present invention includes an assembly according to the invention includes a pressure mechanism having a flexible member for attachment to a limb and an air chamber which may be pumped up into a desired pressurized state, a separate relatively small pre-filled air bladder, an absorbent foam, sponge or dressing coupled to the pre-filled air bladder, and a suction conduit coupled to a source of negative pressure (suction) and in fluid communication with the absorbent foam, sponge or dressing. In a preferred embodiment, the pre-filled air bladder, the absorbent foam, sponge or dressing and the suction conduit are formed together as a unit.
According to one aspect of the invention, the flexible member of the pressure mechanism is adapted to wrap around a leg or arm and over the pre-filled air bladder in order to secure the pre-filled air bladder and the foam, sponge or dressing to a wound or ulcer in the extremity. Thus, the flexible member is provided with some fixation structure such as a hook and loop closure mechanism. An air pumping mechanism is preferably coupled to the air chamber of the pressure mechanism in order to inflate the air chamber to a pressurized state. The air chamber of the pressure mechanism is preferably designed to apply pressure along a predefined area (e.g., the saphenous vein of a leg) as opposed to around an entire limb.
According to another aspect of the invention, the suction conduit is located either between the pre-filled air bladder and the absorbent foam, sponge or dressing which is adhered to the small air bladder, or the pre-filled air bladder is formed as a donut with a central opening and the suction conduit extends through the central opening. By coupling the suction conduit to a source of negative pressure, exudate from the wound or ulcer is sucked through the foam, sponge or dressing into the suction conduit.
One of the methods of the invention include locating the pre-filled air bladder and foam, sponge or dressing over a wound or ulcer on a limb, wrapping the flexible member of the pressure mechanism around a limb with the air chamber located over the pre-filled air bladder/absorbent foam, sponge or dressing, and fastening the pneumatic pressure mechanism in place with the fixation structure. When the apparatus is properly located and affixed to the limb, the air chamber is inflated, preferably to 30-40 mm Hg, thereby applying pressure to the limb and more specifically via the pre-filled air bladder to the wound. The suction apparatus is activated by turning on the source of negative pressure, and exudate from the wound or ulcer is pulled through the absorbent foam, sponge-or dressing into the suction conduit.
Another embodiment of the present invention includes an apparatus for applying intermittent pressure to a portion of the human body, such as an area of the human leg, which assists with the healing and treatment of various conditions such as venous ulcers or wounds by promoting blood flow into and out of the area and by increasing drainage. The apparatus includes a foot bladder and a leg bladder, each having inflatable chambers that accommodate an entering fluid by inflating. The bladders are fluidly coupled by a fluid conduit, and each is preferably equipped with a means for locating it on a portion of the body. In a preferred embodiment, the foot bladder is positioned on a bottom of a foot and the leg bladder is positioned on a lower portion of a leg. As a person walks while wearing the apparatus, a portion of the foot bladder deflates as the person's foot (heel) strikes the ground due to the external pressure placed on the foot bladder, thereby forcing fluid out of the foot bladder, through the fluid conduit, and into the leg bladder, which raises the pressure therein. As the person's foot rolls from heel to toe in the standard walking motion, the external pressure from the person's weight is removed from the foot bladder, resulting in the pressure of the leg bladder being higher than the pressure in the foot bladder. Fluid thus flows back through the fluid conduit and into the foot bladder, which then inflates again to its original state, such that the pressures of the foot bladder and leg bladder are equalized. This process repeats as a person walks, thereby creating a pumping or kneading force on the leg as the pressure in the leg bladder intermittently increases and decreases, thereby promoting blood flow, fluid drainage, treatment, and healing to various parts of the leg.
These and other aspects of the contacts of the subject invention will become more readily apparent from the following description taken in conjunction with the drawings.
So that those having ordinary skill in the art to which the subject invention pertains will more readily understand how to make and use the apparatuses of the subject invention, preferred embodiments thereof will be described in detail herein below with reference to the drawings, wherein:
Preferred embodiments of the subject invention are described below with reference to the accompanying drawings, in which like reference numerals represent the same or similar elements. One of ordinary skill in the art would appreciate that while the apparatuses discussed herein relate to compression therapy of the leg and foot, the scope of the invention is not limited to those exemplary applications and may be sized and shaped for the anatomical portion for which compression therapy is needed.
The subject invention provides compression to a patient's limbs, including the extremities, including for example, the lower leg and foot or an arm and a hand, in a manner that is simpler and more convenient than current systems. Any limb or body part may be compressed by the instant therapeutic compression apparatus such as for instance a foot, calf, thigh, knee, leg, hip, buttocks, waist, torso, ribs, shoulder, arm, hand, fingers, neck, head or the like.
The subject invention provides system for providing compression and preventing swelling of a limb such as for instance the foot using a non-elastic binder and bladder which can be used for compression. The bladder is provided within a non-elastic wrap and creates compression in a manner that allows far consistent measuring of the pressure supplied, as well as safe, comfortable, convenient, effective, self-application by the patient.
Where a range of values is provided, it is understood that each intervening value, to the tenth of the unit of the lower limit unless the context clearly dictates otherwise, between the upper and lower limit of that range and any other stated or intervening value in that stated range is encompassed within the invention. The upper and lower limits of these smaller ranges may independently be included in the smaller ranges and are also encompassed within the invention, subject to any specifically excluded limit in the stated range. Where the stated range includes one or both of the limits, ranges excluding either both of those included limits are also included in the invention.
Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can also be used in the practice or testing of the present invention, exemplary methods and materials are now described. All publications mentioned herein are incorporated herein by reference to disclose and describe the methods and/or materials in connection with which the publications are cited.
It must be noted that as used herein and in the appended claims, the singular forms “a”, “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a stimulus” would include a plurality of such stimuli and reference to “the signal” would include reference to one or more signals and equivalents thereof known to those skilled in the art, and so forth.
The publications discussed herein are provided solely for their disclosure prior to the filing date of the present application. Nothing herein is to be construed as an admission that the present invention is not entitled to antedate such publication by virtue of prior invention. Further, the dates of publication provided may differ from the actual publication dates which may need to be independently confirmed.
Referring now to
The primary wrap 12 may be attached to a patient's limb such as a lower leg 2, for example, by encircling the wrap about the lower leg 2 and attaching it at the peripheral edges 5 and 7 with any number of connecting structures. Hook and loop fastening tabs, such as connecting tabs 32a, 32b, 32c, 32d illustrated in
At a horizontal proximal end 1 of the primary wrap 12 in this instance towards the knee 8, an optional garter or adjustable belt 18 may be provided to further secure the primary wrap 12 about the lower leg 2. The adjustable belt 18 may be connected around the leg 2 using a connecting tab, buckle or other known connecting structures. As shown in
The primary wrap 12 is preferably made of a composite material that is non-elastic and has one or more wicking layers. Because the material is non-elastic, the primary wrap 12 remains stiff and does not stretch when the bladder 22 is filled, or inflated, for example. Referring to
Referring to
The secondary wrap 14 of the therapeutic compression apparatus 10 encircles the limb in this instance the foot 6 and, like the primary wrap 12, may be similarly utilized for both applying compression to the limb such as foot 6 or alternatively as a protective garment for wound care dressings. The secondary wrap 14 helps to prevent swelling of the limb such as the foot 6. The swelling may occur on its own, or as a result of compression of the lower leg 2. The secondary wrap 14 may be optionally made of a continuous piece of material with the stirrup 16, as shown in
The secondary wrap 14 is typically formed of an elastic material, but may also be formed of a non-elastic material or a combination of the two. The secondary wrap 14 may be a single piece of connected material. Alternatively, the secondary wrap 14 may also be secured about the foot 6 or another limb or body part by any number of mechanical securing devices such as one or more hook and loop fastening tabs as shown in
The secondary wrap 14 may have a number of configurations depending on the therapeutic needs of the patient. The secondary wrap 14 may be open-toed to expose the toes of the patient's foot 6 as shown in
The primary wrap 12 supplies compression to a patients limb by non-elastically holding at least one bladder 22 around the treatment site. In one embodiment, for example, localized pressure is provided by the therapeutic compression apparatus 10 near the saphenous vein of the lower leg 2. As shown in
The bladder 22 may be inserted into one or more pockets 20 provided within the primary wrap 12 for storing the bladder 22 at a location where compression will be primarily applied. In this embodiment, the bladder 22 is detachable from the therapeutic compression apparatus 10. In another embodiment, the bladder 22 is permanently integrated within the primary wrap 12 and not detachable (not shown).
According to the subject invention, the bladder 22 may have a number of additional features for monitoring, setting and adjusting the pressure required for a desired therapeutic regimen. In an exemplary embodiment illustrated in
The pressure gauge 28 works in conjunction with the fluid or air pump 30 which pumps air into the bladder 22 through an inflation tube 26 at the inflation inlet 24a. The pump 30 may be a manual pump or an electronic pump for providing air to the bladder 22. An overflow valve 46 may also be provided and limits the amount of air capable of entering the bladder 22, along with a one-way valve 48 for releasing air from within the bladder 22, thereby lowering the pressure within the bladder 22. As shown in
In another embodiment, the bladder 22, itself, may serve as its own pressure gauge, in which the distention of the bladder 22 as it inflates indicates an amount of pressure within the bladder 22. In this instance, the pressure within the bladder 22 is pre-calibrated. Alternatively, more than one bladder 22 can be used, or a bladder 22 having multiple chambers can be used such that the distention of one or more of the bladders 22 or bladder chambers signifies the internal pressure. The subject invention provides pressure within the bladder 22 typically within the range of 20-50 mm Hg.
A number of different embodiments of a bladder 22 can be used in the therapeutic compression apparatus 10 of the subject invention.
In addition to the bladder 22 having spot welds 36 illustrated in
Turning to
Referring to
In this embodiment, hook and loop fasteners 124 are provided along the edge of inner and outer sheets in order to ease adjustment and secure therapeutic compression apparatus 100 on a patient's limb such as for example a lower leg and foot. It is envisioned that the therapeutic compression apparatus 100 can also be secured to a patients lower leg by other means, such as zippered, buttoned, or be cuff shaped by other such suitable means. Further, it is also envisioned that hook and loop closures 124 can be replaced by material similar to that of ankle strap 122 described below and be welded/sewn/attached to bladder 102 for improved comfort.
In this embodiment inflation means is a device 130 which is a hand pump capable of attaching to inflation port 112 to inflate bladder 102. It can be appreciated that a mechanical or automatic inflation puny (not shown) can also be attached to inflation port 112 to inflate and deflate bladder 102 to provide pulsating pressure to a user's lower leg. A number or variety of inflation means can be employed such as a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient. A vent valve (not shown) can also be incorporated into therapeutic compression apparatus 100 or with inflation means 130 to allow a user to selectively deflate bladder 102. Further, a check valve or relief valve is incorporated with either inflation means 130 or bladder 102 to prevent over-inflation once a maximum pressure is detected. Examples of relief valves are described in U.S. Pat. Nos. 7,276,037 and 7,850,629, the disclosures of which are incorporated by reference in their entirety.
Referring now to
It can be appreciated that depending on the location of the therapeutic compression apparatus, different pressure gradients may be utilized. Examples of other bladder pressure gradient profiles are described in U.S. patent application Ser. Nos. 12/911,563 and 12/855,185, the disclosures of which are incorporated by reference in their entirety.
Referring now to
In accordance with an exemplary embodiment, inner sheet 106 further includes a layer (not shown) that has a first elastic modulus, inner sheet 106 has a second elastic modulus. The first elastic modulus is less than the second elastic modulus in a transverse direction relative to the proximal and distal end portions of therapeutic compression apparatus 100 to wrap therapeutic compression apparatus 100 around the leg when the leg compression bladder is inflated. In an exemplary embodiment, inner sheet 106 includes a secondary sheet (not shown) disposed on an inner surface thereof, to directly contact the lower leg in use. The secondary sheet can be a fabric layer, which is elastic in a first direction and inelastic in a second direction to curl the wrap member around the leg when the leg compression bladder is inflated.
In another exemplary embodiment, upper leg strap 128 is configured and adapted to improve wearability of therapeutic compression apparatus 100 by locating a portion of bladder 102 above the widest portion of the calf of a patient and provides stability of therapeutic compression apparatus 100 by preventing therapeutic compression apparatus 100 from slipping down the lower leg of a patient which would make therapeutic compression apparatus 100 ineffective in providing calf compression.
Turning to
Turning to
The air chamber 214 is substantially longer in a first dimension (e.g., the vertical dimension of
The flexible member 212 may include a strap (not shown) that extends around the heal (and/or other parts) of the foot when in use. This strap limits the upward travel of the flexible member 212 when in use. It may also have suspender hooks or slots (not shown) that allow for suspenders to be mated thereto which support the mechanism 210 by a band that wraps around the knee or thigh. The suspenders limit downward travel of the flexible member 212 when in use. These features reduce the travel of the flexible member 212 along the length of the leg such that its desired position is maintained during use. The flexible member 212 may be positioned not only on the foot but also on other limbs or body parts such as the calf, thigh, hip, buttocks, torso, ribs, arm hands, fingers, shoulder, neck, head or the like.
In alternative embodiments, the flexible member 212 and air chamber 214 may be adapted such that they are disposed along a portion of the upper leg (e.g., a portion of the thigh), which enables the air chamber 214 to apply local pressure to such portion of the upper leg when inflated. For treatment of the upper leg, the flexible member 212 may define an opening (not shown) at the knee joint level to enable the patella (knee cap) to protrude therethrough. In this configuration, the flexible member 212 may extend below the knee joint level and securely wraps around portions of the lower leg to provide stability to the leg. It may also have suspender hooks or slots (not shown) that allow for suspenders to be mated thereto in order to support the mechanism 210 by a waist hand when in use. The suspenders limit downward travel of the flexible member 212 when in use such that the flexible member 212 maintains its desired position.
Preferably, the flexible member 212 includes multiple hook and loop closure mechanisms 226A, 226B (e.g., VELCRO™ members). In the preferred embodiment, the flexible member includes four hook and loop closure mechanisms as shown in
Preferably, pressure in the air chamber(s) is reduced/removed (e.g., the air chamber(s) are deflated) by user manipulation of the manual relief valve 224 or check valve, and the pneumatic compression mechanism is removed from the leg by manually detaching the hook and loop closures and unwrapping the flexible member 212 from around the leg.
Turning now to
Preferably, the flexible member 212′ includes multiple hook and loop closure mechanisms (e.g., VELCRO™ members) which enable the flexible member 212′ (and the air chamber(s) 214′ secured thereto) to be securely wrapped around a portion of the human leg. In the exemplary embodiment of
During use, air is pumped into the air chamber(s) 214′ by actuation of the pumping bulb (or other inflation mechanism). The air chamber 214′ is substantially longer in a first dimension (e.g., the vertical dimension of
In the exemplary embodiment shown, the air chamber 214′ has a length of 13.00 inches (Vertical dimension) and width of 3.77 inches and 3.51 inches (horizontal dimension) at its top and bottom ends, respectively, as shown. The width of the chamber 214′ tapers as it extends away from the top and bottom ends to a minimal width, which is located relatively closer to the bottom end as shown. It will be appreciated that the air chamber 214′ may take other shapes and sizes.
In another alternative embodiment as shown in
In the exemplary embodiment shown, the flexible member 212″ is contoured to conform to the upper leg when wrapped around it. The air bladder chamber 214″ has a length of 11.75 inches (Vertical dimension) and maximum width of 6.00 inches (Horizontal dimension) at its bottom end as shown. The width of the chamber 214″ tapers as it extends away from the bottom end to the top end as shown. It will be appreciated that the air chamber 214″ may take other shapes and sizes.
It will be appreciated that the chambers of either of the embodiments of
Other embodiments of the compression mechanism are possible such as a combination of a scaled fluid-filled bladder, an absorbent foam, sponge or dressing, and a suction conduit such as for example corresponding to bladder B, foam, sponge or dressing C and at least a portion of suction conduit D of
The fluid-filled member 238 may be formed in many of numerous ways. In one arrangement, the fluid-filled member includes two walls 242A, 242B that are bonded together, preferably by heat sealing, about a flange portion (not shown). The two walls define a chamber 246 therebetween that is filled with fluid. The fluid held in the chamber 246 can be a gas (such as air), a liquid (such as water), or a gel. The fluid inside the chamber 246 may be loaded with one or more therapeutic agents, such as antibiotics, growth factor, absorbents. In such configurations, the bottom wall 242B is realized from a semi-permeable material that allows the therapeutic agents retained in the chamber 246 to migrate through to the treatment site while maintaining the desired internal pressure in chamber 246. Such fluid might also be a gel compound that retains heat and/or cold such that is useful for hot and/or cold therapy of the treatment site.
The fluid-filled member 238 preferably has an oval shape with a length on the order of four to six inches, a width on the order of two to four inches, and a height on the order of one-quarter to three-quarters of an inch. Enough fluid is preferably provided to prevent the walls of the member 238 from sagging and touching each other, although some sagging can be tolerated. The walls of fluid-filled member 238 may be formed from polyurethane, polyvinylchloride, nylon, or other plastic(s) known in the art and are of sufficient thickness (i.e., are sufficiently strong) such that the fluid-tilled member 238 will not burst when 40 mm Hg is applied to it by the compression mechanism. It will be appreciated that the fluid-filled member 238 may take other shapes and sizes, and may be formed from other materials.
Attached to the fluid-filled member 238 is the absorbent foam, sponge or dressing 245 (hereinafter referred to as “the sponge”). The sponge 245 has the ability to absorb exudate from the wound or ulcer. In addition, the sponge preferably has an open-cell structure which aids in wicking the exudate from the wound or ulcer. The sponge 245 is preferably of a similar size and shape as the fluid-filled member. The sponge 245 is preferably fixed by adhesive to the bottom wall 242B of the fluid-filled member such that that the sponge 245 and the fluid-filled member 238 cannot be easily separated from each other. Alternatively, the sponge may be lightly affixed to the fluid-filled member 242B by an adhesive film such that the sponge may be peeled off and replaced. As another alternative, the fluid-filled member 238 may be provided with a circumferential holding flap for the sponge 245 which may be inserted and into and removed from the flap as desired. If desired, the circumference of the sponge may be sealed either by injecting sealant into the sponge or by collapsing the open-cell structure of the sponge. Sealing the circumference of the sponge can help reduce air from entering the sponge when suction is applied to the unit as described below.
Some embodiments in the unit 230 may include a suction conduit 247 for example provided in between the fluid-filled member 238 and the sponge 245. More particularly, suction conduit 247 may be a tube having a bifurcated distal end 249 which defines a series of holes 251. The holes 251 may be oriented downwardly (towards the sponge 245 so that when a source of negative pressure is applied to the suction conduit 247, that negative pressure is applied to the wound or ulcer via the sponge 245. As a result, exudate can be wicked and suctioned away from the wound or ulcer via the sponge 245 and into the conduit 247. In another embodiment, the bifurcated distal end 249 of the suction conduit 247 extends only partially around the periphery of the unit 230. The proximal end of the conduit may couple to a bottle or other reservoir (not shown) which is also coupled to a source of negative pressure S (shown in
The suction conduit 247 may be held between the fluid-filled member 238 and the sponge 245 preferably by an adhesive (not shown) which is applied to the top and bottom of the distal end 249 of the conduit 247, and which binds the distal end 249 to the sponge 245 on its bottom and to the fluid-filled member 238 on its top. Alternatively, the suction conduit 247 may be heat sealed or laser-sealed to the fluid-filled member 238 and/or the sponge 245. In embodiments where the sponge 245 is removable from the fluid-filled member 238, the conduit 247 is preferably adhered only to the bottom of the fluid-filled member 238.
Another embodiment of a unit incorporating a pre-filled air bladder, a sponge and a suction conduit (corresponding to bladder B, foam, sponge or dressing C and suction conduit D of
A third embodiment of a unit including a pre filled air bladder, a sponge, and a suction conduit (corresponding to bladder B, foam, sponge or dressing C and suction conduit D of
In accord with one aspect of the invention, the units 230, 230′ and 230″ may be provided with additional means for holding the unit in place over the wound or ulcer. Thus, the periphery of the unit might be provided with a biocompatible adhesive. The adhesive could be provided on the sponge, or the fluid-filled member might be provided with a flange (not shown) having a biocompatible adhesive. Alternatively, and as shown in
In use, a patient or practitioner will select a unit 230, 230′, 230″, and locate the unit sponge face down over, a wound or ulcer. If the unit includes straps, the unit can be strapped in place on the limb. Alternatively, if the unit includes an adhesive ring, the unit is located such that the adhesive ring is preferably located on healthy skin as opposed to the wound or ulcer. Once the unit is located, an appropriate compression mechanism 10, 110, 210, 210′, 210′, 210″ or other embodiments is wrapped over the limb with the air chamber 14, 214, 214′, 214″, 114 or other embodiments located over the unit 230, 230′, 230″. When desired, the air chamber is pressurized (or pressure is applied by fixation of the wrap) so that pressure is applied by the compression mechanism to the limb and to the unit. Application of pressure to the unit applies specific pressure to the wound or ulcer and aids in the healing process. Also, when desired, suction is applied to the wound or ulcer by applying a source of negative pressure via the suction tube 247, 247′, 247″ to the unit. Where the sponge is circumferentially sealed, the amount of suction required to move exudates is lessened. The suction and pressure may be applied together or alone (alternatingly), or one or the other may be constantly applied and the other turned on and off as needed. When applied together, positive mechanical pressure is applied to the wound or ulcer by the compression mechanism and the unit, while negative air pressure is applied to the wound or ulcer via the sponge by the source of negative pressure, thereby removing exudates and further aiding in the healing process. In addition, if desired, a pressure sensor (not shown) may be incorporated with unit 230, 230′, 230″ and electrically coupled to the suction source S (typically via a wire—not shown—running along suction tube 247, 247′, 247″), where the suction source S has an on/off control (not shown). In this manner, the source S of negative pressure can be turned on and off as a function of the mechanical pressure applied by the compression mechanism and the unit as sensed by the sensor (not shown). Thus, if the pressure is above a desired threshold, the suction can be turned on, and if the pressure is below that or a lower threshold the suction can be turned off or if desired, if the pressure is above a desired threshold the suction can be turned off, and if the pressure is below that or a lower threshold the suction can be turned on. The pressure sensor (not shown) can be located between the fluid-filled member 238, 238′, 238″ and the sponge 245, 245′, 245″, or in the sponge, or on a surface of the fluid-filled member. Alternatively, the pressure sensor (not shown) can be associated with the air chamber 14, 114, 214, 214′, 214″ or other embodiments of the flexible member 12, 112, 212, 212, 212′, 212″ or other embodiments.
Where the sponge is separable from the fluid-filled chamber, the sponge may be replaced at desired intervals. If not separable, the entire unit may be replaced as desired. Where the unit has a fluid coupling, the suction tube may be detached prior to replacement of the unit. This unit can be placed under the therapeutic compression apparatus 10, 100, 200, 300, 400 and assembly 310 so that the negative pressure is coupled with the compression for treatment of CVI, DVT and/or lymphedema.
For purposes of explanation and illustration, and not limitation, another exemplary embodiment of the present invention is shown in
Turning to
The primary bladder 312 is best seen with reference to
In one embodiment, the primary bladder 312 has a nozzle or connector element 318 extending through the upper wall 322 with a first end 318a inside the inflatable chamber 312a and a second end 318b outside of the inflatable chamber 312a. The nozzle 318 receives the fluid conduit 316 at the first end 316a of the fluid conduit 316 (
In another embodiment (not shown) the primary bladder 312 does not contain a nozzle 318. Instead, the first end 316a of the fluid conduit 316 is integrally formed with the primary bladder 312 such that the fluid conduit 316 is inseparable from the primary bladder 312, An optional one-way valve 68 is provided as described below. If not provided, then the system is a closed system that is pressurized during a manufacturing process, and thus does not require the primary bladder 312 or any other component of the apparatus 10 to be pressurized prior to its operation.
Referring to
The lower wall 320, upper wall 322, and bottom layer 330 of the fluid primary bladder 312 may be formed in a variety of shapes and from a variety of materials, but flexible plastic or rubber is preferred so that the fluid primary bladder 312 may bend to accommodate the specific contour and curves of a given leg. The size of the primary bladder 312 may be varied, and different sizes may be chosen depending on the size and location of the wound. The upper wall 322 of the fluid primary bladder 312 is preferably made from a material such as a flexible and resilient plastic (e.g., polyurethane, polyvinylchloride (PVC), or polypropylene) that changes shape in order to permit the volume of the inflatable chamber 312a to increase as additional fluid enters therein. The material of the upper wall 322 should be non-rigid so that as pressure increases inside the inflatable chamber 312a, the pressure is not absorbed by the upper wall 322, but rather, is transmitted through the wall to the leg. The operation of the primary bladder 312 as part of the overall apparatus 10 is discussed in more detail below.
The fluid secondary bladder 314 is best seen with reference to
In one embodiment as shown in
In one embodiment, the secondary bladder 314 may have a nozzle or connector element 346 extending through the upper wall 336 with a first end 346a inside the inflatable chamber 314a, and a second end 346b outside of the inflatable chamber 314a. The nozzle 346 receives the fluid conduit 316 at the second end 316b of the fluid conduit 316 (
In another embodiment the secondary bladder 314 does not contain a nozzle 346. Instead, the second end 316b of the fluid conduit 316 is integrally formed with the secondary bladder 314 such that the fluid conduit 315 is inseparable from the secondary bladder 312. As described above, an optional one-way valve 368 is provided as described below. If not provided, then the system is a closed system that is pressurized during a manufacturing process, and thus does not require the secondary bladder 314 or any other component of the apparatus 10 to be pressurized prior to its operation.
In the bent configuration described above as shown in
The secondary bladder 314 is preferably equipped with at least two front and/or rear straps 352, 354 which wrap around the foot to secure the fluid secondary bladder 314 to a bottom portion of the foot. The straps 352, 354 preferably include Velcro sections 360 that overlap and attach to each other after wrapping around the foot. The front straps 352 extend from a front flap 358 that is attached to the lower wall 334 or flange 342 of the secondary bladder 336 by heat seal, glue, stitching, or other equivalent means. The front straps 352 extend away from the front flap 358. The rear straps 354 connect directly to either the flange 342 or the lower wall 334 of the secondary bladder 314 by heat sealing, glue, stitching, or other equivalent means. The rear straps 354 start at a rear portion of the secondary bladder 314 and may be pulled up towards the top of the foot in front of the leg, and wrapped over the top of the foot. The rear straps 354 also have VELCRO™ sections (not shown) that overlap and attach to each other on the top of the foot. In one embodiment, the front and rear straps 352, 354 are wrapped with tension over the top of the foot such that a continuous compressive force is exerted on the inflatable chamber 314a as it is positioned securely to the heel. The rear straps 354 should not be pulled so tightly that the nozzle 346 extending upward from the connecting section 350 is compressed.
Different embodiments of a secondary bladder may include a crescent-shaped with inflatable chamber 314a′ and nozzle 346, or a rectangularly shaped with inflatable chamber 314a″ and nozzle 346″. The secondary bladders 314′ and 314″ attach to the heel such that the bulk of each inflatable chamber 314a′, 314a″ is operably disposed underneath the heel and bottom of the foot. In such embodiments, the inflatable chamber is not divided into a compression section 348 and a connecting section 350 because most if not all of the inflatable chamber is compressed when the heel strikes the ground.
In all embodiments, the amount of fluid in the secondary bladder is chosen so that the primary bladder can accommodate all of the fluid of the secondary bladder when that fluid is forced out of the secondary bladder by the walking motion. Preferably, the system is arranged such that the primary bladder generally applies a constant pressure of 30-40 mm Hg to a wound site, and when fluid is forced out of the secondary bladder due to the walking motion, the pressure in the primary bladder is increased by an additional 10-20 mm Hg. While it is possible to tolerate higher intermittent pressures (e.g., 80 mm Hg), a maximum pressure of 50-60 mm Hg is preferred.
In the configuration of
As shown in
In the embodiments of the present invention in which the fluid conduit 316 is integrally formed with and permanently connected to the bladders 312, 314, the apparatus 10 is a closed system. Such embodiments do not require the pressurization of either of the bladders 312, 314 or of the fluid conduit 316 prior to their use. Rather, during the manufacturing process of apparatus 10, the ends 316a, 316b of the fluid conduit 316 are fluidly coupled to and form airtight seals with the inflatable chambers 312a, 314a. During the heat sealing of one or both of the inflatable chambers 312a, 314a, the amount of fluid trapped in the system is controlled. Alternatively, if a one-way valve/nozzle 368 is provided, then after the fluid conduit 316 is permanently attached to the, bladders 312, 314, pressurization of the therapeutic compression apparatus 300 and assembly 310 may take place by means of the one-way valve/nozzle 368 such as a check valve or relief valve. The one-way valve/nozzle 368 is used to pressurize the therapeutic compression apparatus 300 and assembly 310 to a desired pressure by connection to a fluid source such as an air pump. Once the desired pressure is reached (which may be below the ambient air pressure), the fluid source is removed from the one way valve 368, which closes. In such embodiments, nozzles 318, 346 are not necessary because the therapeutic compression apparatus 300 and assembly 310 are a closed system. Fluid flows freely between the bladders 312, 314 through the fluid conduit 316 (with the pressure in each of the bladders 312, 314 varying as the therapeutic compression apparatus 300 and assembly 310 is operated in the manner discussed below), but no additional fluid is allowed into the apparatus 10. The apparatus 10 is secured to the body by attaching the foot and primary bladders 314, 312 to the foot and leg as discussed herein. The one way valve 368 such as a check valve or relief valve may alternatively be located on either of the inflatable chambers 312a, 314a of the bladders 312, 314 rather than on the fluid conduit 316.
In other embodiments, the fluid conduit 316 is detachably connected to the nozzles 318, 346 of the primary bladder 312 and secondary bladder 314. In such embodiments, the ends 316a, 316b of the fluid conduit may be inserted through the nozzles 318, 346 to fluidly couple the primary bladder 312 with the secondary bladder 314 in an airtight manner. The air-tight connection between the fluid conduit 316 and the nozzles 318, 346 may be accomplished by male and female threaded surfaces, bayonet locks, or other equivalent means known in the art. The nozzles 318, 346 may contain two way valves (not shown) for pressurizing either or both of the inflatable chambers 312a, 314a prior or subsequent to attaching the fluid conduit 316. The fluid conduit 316 is preferably made from rubber or plastic and by way of example and not by way of limitation has a diameter in the range of ¼ to ½ inch, a length in the range of two to twelve inches, and walls having a thickness in the range of ⅛ to ½ inch. This wall thickness is recommended to prevent or minimize expansion of the fluid conduit 316 as the pressure varies therein throughout the operation of the therapeutic compression apparatus 300 and assembly 310 (i.e., the tube preferably can withstand pressures of 60 mm Hg and above without expanding).
In embodiments in which the fluid conduit 316 is permanently attached to the bladders 312, 314, the therapeutic compression apparatus 300 and assembly 310 are assembled by simply attaching the foot and primary bladders 314, 312 to the foot and leg as described herein. No additional set-up is necessary.
In embodiments in which the fluid conduit 316 is detachably connected to the bladders 312, 314, the apparatus may be assembled by either first attaching the foot and primary bladders 314, 312 to the foot and leg, and then connecting the fluid conduit 316 to the nozzles 318, 346, or by first connecting the fluid conduit 316 to the foot and primary bladders 314, 312, and then connecting the foot and primary bladders 314, 312 to the foot and leg. In such embodiments, a fluid is supplied into either the inflatable chamber 312a of the primary bladder 312 or the inflatable chamber 314a of the secondary bladder 314 (or both) through the nozzles 318, 346 from a fluid source such as an air pump. As fluid is supplied, the bladder(s) 312, 314 will inflate and pressurize. When the fluid source is removed from the nozzles 318, 346, the valves in the nozzles will maintain the pressure in each of the bladders 312, 314. The fluid conduit 316 may then be pinched at one of the two ends 316a, 316b while the other of the two ends 316a, 316b is coupled to one of the nozzles 318, 346. The fluid conduit 316 opens the valve within the nozzle as it enters therein. The pinched end of the fluid conduit 316 is then coupled to the other nozzle, which opens that nozzle's valve, and the apparatus 10 is then ready for operation. The fluid, used inside of the therapeutic compression apparatus 300 and assembly 310 may be air, liquid, or a combination of both depending on the fluid source desired, the pressure desired, and the specific materials used.
In yet another embodiment of the present invention, the primary bladder 312 is positioned on the leg by means of a flexible leg wrap apparatus 370 such as the one disclosed in the commonly owned U.S. Pat. No. 7,276,037, which has been incorporated by reference in its entirety. The leg wrap apparatus 370, shown in
In one embodiment, the inflatable chambers 312a, 314a of the leg and secondary bladders 312, 314 are prefilled such that when they are secured to the leg and foot and used in conjunction with the leg wrap apparatus 370, the leg wrap apparatus causes the primary bladder 312 to substantially deflate when a patient is lying down or has the foot elevated while walking (i.e. when the foot is not compressing the secondary bladder 314). In such embodiments, it is preferred that the fluid displaced from the primary bladder 314 to the secondary bladder 312 cause the inflatable chamber 312a of the secondary bladder 312 to inflate to approximately one-half to three-quarters of its maximum volume. In these embodiments, the leg wrap apparatus 370 alone puts pressure on the saphenous vein of the patient while the patient is lying down or has his or her foot elevated. When, the secondary bladder 314 is compressed during the standard walking motion, fluid is displaced from the secondary bladder 314 back to the primary bladder 312, increasing the pressure therein. This intermittent on and off compression will help to promote circulation to an ulcer bed disposed on the patient's leg underneath the primary bladder 112 and leg wrap apparatus 370.
The inflatable air bladder 372 is optionally provided with a pressure gauge and an automatic pressure relief valve coupled to the inflatable air bladder chamber 372 to vent air from the chamber 372 to the ambient environment when the internal pressure reaches a threshold maximum pressure. For example, the therapeutic compression apparatus 300 and assembly 310 may be attached to the leg and foot as described above in any of the embodiments. The flexible member 373 is then wrapped with tension around the leg and over the primary bladder 312 with the air bladder chamber 372 touching the inflatable chamber 312a and exerting a pressure thereon (
Once the therapeutic compression apparatus 300 and assembly 310 is assembled and fastened to a person as discussed above, the therapeutic compression apparatus 300 and assembly 310 operates as a person walks. During the standard heel to toe motion of walking, the compression section 348 of the secondary bladder inflatable chamber 314a is squeezed between the heel and the ground, which puts external pressure on the compression section 348 forcing all or most of the fluid out thereof, (i.e. the compression section 348 of the inflatable chamber 314a of the secondary bladder 314 deflates as a heel strikes the ground). Fluid is thus pushed Up through the connecting section 350 of the inflatable chamber 314a, into and through the fluid conduit 316, and up into the primary bladder 312. The inflatable chamber 312a of the primary bladder 312 inflates to accommodate the entering fluid. As the inflatable chamber 312a inflates, the sidewall 326 of the inflatable chamber 312a presses against the straps 332 of the primary bladder and/or the flexible member 373 of the leg wrap apparatus 370. The straps 332 and/or flexible member 373, which are securely fastened to the leg with tension and preferably extend over the top of the inflatable chamber 312a, provide resistance to the sidewall 126 flexing or bowing outward, which limits the volume increase of the inflatable chamber 312a. The additional fluid entering the inflatable chamber 312a thus causes an increase in the pressure therein. This increased pressure is transmitted through the lower wall 320 and/or bottom layer 330 to the leg.
When the person's foot rolls from heel to toe, the external pressure from the person's weight is removed from the heel. At that point, the pressure in the fluid conduit 316 and the inflatable chamber 312a of the primary bladder 312 is greater than the pressure in the inflatable chamber 314a of the secondary bladder 314. Because in equilibrium the pressures will be equal, a portion of the fluid in the primary bladder 312 flows back through the fluid conduit 316 into the inflation chamber 314a of the secondary bladder 314, which expands back to its original state, until the pressure therein equals the pressure in the primary bladder 312 and the fluid conduit 316. This process repeats as the person walks, which creates a pumping or kneading force on the wound area of the leg over which the primary bladder 312 is placed as the pressure in the primary bladder 312 increases and decreases, thereby promoting blood flow, drainage, treatment, and healing to various parts of the leg.
The pressure in the inflatable chamber 312a of the primary bladder 312 is impacted by a number of factors. It should be noted that if the primary bladder 312 is pressurized before placing it on the leg, then the pressure inside the inflatable chamber 312a will increase when it is placed on the leg prior to the straps 332 being secured because the volume of the inflatable chamber 312a decreases slightly as the lower wall 3320 curves to conform to the shape of the leg. The straps 332 further increase the pressure on the inflatable chamber 312a as they are secured thereto. In addition, in embodiments in which the fluid conduit 316 is detachable, the pressure in the apparatus 10 may be varied by pressurizing one or both of the primary bladder 312 and secondary bladder 314, or by using a longer or wider fluid conduit 316, which increases the internal volume of the apparatus 10. The pressure may also vary as a function of the tightness with which the straps 332 are wrapped around the, leg and/or placed over the inflatable chamber 312a, and the tension with which the straps 352, 354 are wrapped around the foot and/or placed over the inflatable chamber 314a. For example, a greater tension of the straps around the leg and/or inflatable chamber 312a of the primary bladder 312 produces a greater inwardly directed (minimum) compressive force on the leg. The operation of the apparatus 10 to inflate the inflatable chamber 312a will produce additional pressure on the leg as the inflatable chamber 312a inflates, encounters resistance from the straps and continues to fill with fluid without a corresponding increase in volume.
Yet another embodiment of the present invention is shown in
Hook and loop fasteners 424 are provided along the edge of inner and outer sheets in order to ease adjustment and secure therapeutic compression apparatus 400 on a patient's lower leg and foot. It is envisioned that therapeutic compression apparatus 400 can also be secured to a patient's lower leg by other means, such as zippered, buttoned, or be cuff shaped by other such suitable means. Further, it is also envisioned that hook and loop closures 424 can be replaced by material similar to that of ankle strap 422 described below and be welded/sewn/attached to bladder 402 for improved comfort.
In one embodiment of the present invention inflation means 700 is a hand pump which can attach to inflation port 500 to inflate bladder 402. It can be appreciated that a mechanical or automatic inflation pump (not shown) can also be attached to inflation port 500 to inflate and deflate bladder 402 to provide pulsating pressure to a user's lower leg. A number or variety of inflation means can be employed not limited to a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation as to provide a certain pressure within the bladder so to provide compression in use by the patient. A vent valve is also be incorporated into therapeutic compression apparatus 400 or with inflation means 700 to allow a user to selectively deflate bladder 402. Further, a relief valve is also incorporated with either inflation means 700 or bladder 402 to prevent overinflation once a maximum pressure is detected. Examples of relief valves are described in U.S. Pat. Nos. 7,276,037 and 7,850,629, the disclosures of which are incorporated by reference in their entirety. Further examples are shown in
In another embodiment of the present invention the therapeutic compression apparatus 400 can be formed by first forming bladder 402 to be integral within inner sheet 406 and outer sheet 408, the location and desired preconfigured compression gradient profile can be obtained cost-effectively. A number of different embodiments of bladder configurations can be used in the therapeutic compression apparatus of the subject invention such as those configurations described above. In another embodiment therapeutic compression apparatus 400 may have a bladder 402 with a plurality of spot welds 414 therein. Spot welds 414 may be strategically placed within bladder 402 in a predetermined pattern based on the desired gradient profile relative to the compression needed at the patient's treatment site. Spot welds 414 enable bladder 402 to define the gradient profile when inflated through inflation port 500. The geometric placement of spot welds 414 within bladder 402 allows increased inflation of certain portions of bladder 402, and can create one or more fluid chambers within bladder 402. This configuration is particularly useful when compression is needed to improve fluid movement (e.g., blood, lymph, etc.) within the body. Further, linear weld lines 416 allow for better compression along the back of a patient's calf by increasing tension applied to the back of the calf of a patient. This increased tension can generate a more effective calf compression in order to increase venous flow. Linear weld lines 416 located laterally along the back of the calf create a ribbed portion, which keeps the inflated profile of therapeutic compression apparatus 400 compact which can further increase ambulation and reduce interference with a patient's clothes. Secondary wrap 404 can also be made from an elastic garment without bladder 402.
It can be appreciated that depending on the location of the therapeutic compression apparatus being placed on the patient's body part or limb, different pressure gradients may be utilized. Examples of other bladder pressure gradient profiles are described in U.S. patent application Ser. Nos. 12/911,563 and 12/855,185, the disclosures of which are incorporated by reference in their entirety.
Once therapeutic compression apparatus 400 is secured around a patient's limb such as for instance a lower leg, bladder 402 is not able to shift out of place, thus increasing comfort and reducing fitting issues on the patient. In order to increase the ease of ambulation by a patient, in an exemplary embodiment, ankle cushion 426 can be attached adjacent heel port 420 to prevent the occurrence of a pinch point and reduce pressure on a patient's Achilles tendon. In combination with ankle cushion 426, ankle strap 422 can be used in an exemplary embodiment, ankle strap 422 can include non-elastic foam which prevents a pinch point at the bottom of lower leg wrap 403 and the upper part of secondary wrap 404. A further advantage to providing ankle strap 422 is that bladder 402 proximate ankle strap 422 is pulled tight against a patient's leg and improves compression near the heel of a patient. Ankle strap 422 is advantageously wrapped around the patient's ankle and foot prior to affixing hook and loop fasteners 424. In order to improve comfort, through-holes 418, as seen in
In accordance with an exemplary embodiment, inner sheet 406 further includes a layer (not shown) that has a first elastic modulus, inner sheet 406 has a second elastic modulus. The first elastic modulus is less than the second elastic modulus in a transverse direction relative to the proximal and distal end portions of therapeutic compression apparatus 400 to wrap therapeutic compression apparatus 400 around the leg when the leg compression bladder is inflated. In an exemplary embodiment, inner sheet 406 includes a secondary sheet (not shown) disposed on an inner surface thereof, to directly contact the lower leg in use. The secondary sheet can be a fabric layer, which is elastic in a first direction and inelastic in a second direction to curl the wrap member around the leg when the leg compression bladder is inflated.
In another exemplary embodiment, upper leg, strap 428 is configured and adapted to improve wearability of therapeutic compression apparatus 400 by locating a portion of bladder 402 above the widest portion of the calf of a patient and provides stability of therapeutic compression apparatus 400 by preventing therapeutic compression apparatus 400 from slipping down the lower leg of a patient which would make therapeutic compression apparatus 400 ineffective in providing calf compression.
The inflation means or mechanism for each of the various embodiments or the present invention may include a hand pump, electric pump, battery-operated pump, remote controlled pump, air pump, gas pump, or any other known inflation means. A number or variety of inflation means can be employed such as a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient.
Further, the therapeutic compression apparatus may be deflated by the valve cap or in another embodiment has a button or a switch to deflate the primary and/or secondary bladder and thus release the pressure. In any embodiment where there is one bladder running the length of both the primary wrap and secondary wrap, the term “primary and/or secondary bladder” shall mean the sole primary bladder or compression bladder (402). In another embodiment as shown in
The inflation means and valves shown in
The inflation means 700 shown in
Another embodiment of the inflation means is shown in
Another embodiment of the inflation means (not shown) is includes a plunger assembly. The plunger assembly includes an umbrella valve (similar to the umbrella valves 616 shown in
Another embodiment of the inflation means 1000 is shown in
Another embodiment of the inflation means 1100 is shown in
In another embodiment of the present invention the compression apparatus may be a stand-alone thigh compression or thigh compression portion added to the leg and foot compression apparatus of the various other disclosed embodiments. The thigh compression apparatus includes an inner layer and an outer layer. The outer layer has joined to it an inflation port which is capable of connecting or joining to an inflation means. The inner layer includes a plurality of fasteners. In one embodiment the thigh compression apparatus includes, by way of example only, hook and loop fasteners along the edge to ease adjustment and secure therapeutic compression apparatus on a patient's thigh. Other uses of the thigh compression apparatus may be used such as on the back, calf, arm, stomach, torso, shoulder and other body parts, such that the designation as the “thigh” compression apparatus is not limited to only use of such apparatus on the thigh of a patient. It is envisioned that compression apparatus can also be secured to a patient's thigh or other body part by other means, such as zippered, buttoned, or be cuff shaped by other such suitable means.
The inventive therapeutic compression apparatus may be included in a kit having various wound dressings and/or bandages. The wound dressings and/or bandages may be disposed of on a more frequent basis and the inventive therapeutic compression apparatus is applied in conjunction or combination with the wound dressings and/or bandages. In one embodiment the therapeutic compression apparatus is used over or on top of the wound dressing applied to the skin.
Another embodiment of the present invention includes a method of applying a measured compression amount with feedback. As shown in
Another embedment of the present invention includes a Sequential Gradient Compression with Single Chamber. As shown in
Another embodiment of the present invention include an electric or other automated inflation means such that the bladder is inflated to a set volume or by reading the back pressure of which is being filled in. A pressure cycling function may be included. Further, an embodiment may have an inflation means such that the inflation maintains in the bladder(s) even after the inflation means is removed. Such inflation means may be integral to the compression apparatus itself or may be removable. Such inflation means may include an integrated circuit and/or wireless capability for tracking of usage, pressure, compliance by the patient in regard to maintaining certain pressures recommend by a physician or part of such patient's treatment plan, and other health data such as standing pressure and moving or working pressure, pedometer (number of steps), heartbeat, blood pressure and any other possible monitoring of the patient. Depending on the feedback obtained the inflation means may be programmed to increase or decrease the pressure without manual changing by the patient. Further, the inflation means may be configured so that the physician or other treatment professional may increase or decrease the pressure remotely based on the feedback. Other combinations may be included such as manual changing of the dial or inflation means in combination with automated means or electric means or digital means.
The dials shown are non-digital by way of non-limiting example only but a digital means may also be employed. A motorized pump and digital display may be used. The valve may include digital or electric means to change or modify pressure at a set rate or intervals or based on feedback from the monitoring means. The apparatus may include various sensors and monitors.
In use the therapeutic compression apparatus 10, 100, 200, 300 or 400 may be placed by the patient, practioner or care-giver on the chosen limb, such as for instance the lower leg on the calf and foot and the secondary wrap, or the foot wrap is fastened around the foot of the patient. The opening aperture for the ankle is set by the patient for comfort. Moving in an up yard position from the foot then the patient, practioner or care-giver fastens or secures the fastening tabs (such as 32a, 32b, 32c, 32d, and 424, etc.) up to the knee. If there are additional straps located on the proximal end of the primary bladder or calf or leg bladder (near the knee) the first strap should be closed or secured in a tight fashion so that the therapeutic compression apparatus fits snugly but not too tight and the second strap near the distal end of the secondary wrap (near the foot) should be closed or secured in a tight fashion so that the therapeutic compression apparatus fits snugly but not too tight. The patient, practioner or care-giver then removes the valve cap from the valve located on the therapeutic compression apparatus such as for instance on the primary wrap. The patient, practioner or care-giver then selects as pressure amount of value on the dial of the inflation means depending on the treatment and whether the patient will be walking, sitting, lying down or traveling in a vehicle, train or airplane. Once the pressure amount or value is chosen on the dial (such as a given pressure amount such as “35” mm-Hg or a text such as “Walk” or “Air” or “Travel” or “Low” or “Medium” or “High”), the corresponding umbrella valve or switch is activated such that the pressure is thereafter maintained (closed position) or modified so as to maintain the pressure as it changes with the activity or altitude when in use). The patient, practioner or care-giver then inserts an end of the inflation means into the valve on the therapeutic compression apparatus and the air or fluid is increased to inflate the primary and/or secondary bladder and thus achieve a desired pressure amount or valve. Again this, inflation means may be a hand pump, electric pump, battery-operated pump, remote controlled pump, air pump, gas pump, or any other known inflation means. A number or variety of inflation means can be employed such as a manual pump, hand pump, foot pump, mechanical pump, electrical pump, battery-operated pump, static pump, intermittent pump, varying pump, automatic pump, pneumatic pump, negative pressure pump, suction pump or vacuum, pulsing pump, or any other known or developed source of inflation so as to provide a certain pressure within the bladder so to provide compression in use by the patient. Depending on the inflation means employed such inflation means may be removed and the valve cap replaced and the pressure will not decrease except as noted in the “Air” or “Walk” position. At any point in use the patient, practioner or care-giver can deflate the primary and/or secondary bladders by either inserting the valve cap so it depresses the valve spring and thus release the air or fluid in the primary and/or secondary bladder and decrease the pressure, or the patient, practioner or care-giver can reinsert the inflation means and select the “Deflate” or “Release” and the corresponding umbrella valve will be in the open position so as to release the air or fluid in the primary and/or secondary bladder and decrease the pressure until a deflated state is achieved for the bladder and the therapeutic compression apparatus. The therapeutic compression apparatus can be reinflated and deflated over and over again when in use.
The present invention has been illustrated and described with respect to specific embodiments thereof, which embodiments are exemplary and illustrative of the principles of the invention and are not intended to be exclusive or otherwise limiting embodiments. For instance, while in the foregoing embodiments the therapeutic compression apparatus are described as having inflatable bladders, the therapeutic compression apparatus may additionally include integrally formed or attached (e.g., by adhesive, radio-frequency welding, etc.) compression members that are not configured for inflation and/or deflation. For instance, additional compression members may be implemented using any of a variety of preformed and/or prefilled cushioning materials such as foam cushions and/or air, gel, or other fluid filled non-inflatable cushions, provided such compression members generate sufficient compression in combination with integral compression bladders. Further, while particular shapes, sizes, and materials have been described for purposes of illustration, it will be recognized that any of a variety of shape or size can be used, and the materials described are not exclusive but merely illustrative. Also, as noted above, while the bladder shown is inflated with air, it will be appreciated that any other fluid or medium such as liquid or gel can be used. Moreover, as also noted, it will be understood that bladders may be configured to have multiple pneumatically independent and/or pneumatically coupled bladder sections, and may also be configured to have various contours or lobulations.
The therapeutic compression apparatus described herein can be used for any suitable condition treatable by compression therapy and the like. For example, therapeutic compression apparatus in accordance with the present invention can be used for compression of the venous system for the treatment of venous ulcers, CVI, DVT, for the treatment of lymphedema (where it is circulation of fluids in the lymph system rather than in the venous system that is promoted), and the like.
The therapeutic compression apparatus of the instant invention described herein solves many problems with the prior art and in the industry and treatment of patients. The therapeutic compression apparatus may be applied on the patient's body part by the patient without the need or requirement of a skilled care-giver as required by current devices and apparatus. It further is capable of maintaining sufficient effective pressure without overpressure complications, maintaining compression and the like.
The therapeutic compression apparatus of the instant invention includes a universal inflation port which is configured to be capable of connecting to more than one source of compression or inflation means such that the patient could vary treatment through varying the inflation source and inflation means for the treatment apparatus or device. For instance, a patient using The therapeutic compression apparatus of the instant invention can alternate between a manual or mechanical or electrical inflation means or source of inflation and pressure. Further, the patient can alternate between static or intermittent inflation and pressure when using the inventive therapeutic compression apparatus
The therapeutic compression apparatus of the instant invention also reduces the problem is leakage of set compression within the treatment apparatus and devices, bandages, stockings and hosiery and instead promotes a more effective treatment for CVI, DVT and/or lymphedema and other treatments.
While the subject invention of the present disclosure has been described with respect to preferred and exemplary embodiments, those skilled in the art will readily appreciate that various changes and/or modifications can be made to the invention without departing from the spirit or scope of the invention as described herein. There have been described and illustrated herein several embodiments of an intermittent pressure apparatus and a method of installing and operating same. While particular embodiments of the invention have been described, it is not intended that the invention be limited thereto, as it is intended that the invention be as broad in scope as the art will allow and that the specification be read likewise. Thus, while particular shapes and sizes of inflatable bladders and straps have been disclosed, it will be appreciated that other shapes, sizes, and attachment means may be used as well, It will also be understood that while Velcro and adhesive means have been disclosed for helping to secure the bladders to the leg and foot, other types of attachments such as hooks, snaps, or wraps may be used. In addition, it will be appreciated that while the fluid conduit may be detachably connected to the bladders using mating threaded portions or bayonet locks, other means of attachment known in the art may be used. It will therefore be appreciated by those skilled in the art that yet other modifications could be made to the provided invention without deviating from its spirit and scope as claimed.
The present application claim priority from provisional application Serial No. 62/378,581 filed Aug. 23, 2016, and priority from co-pending application and this PCT application is a continuation-in-part of U.S. patent application Ser. No. 13/444,600 which is a divisional of U.S. patent application Ser. No. 12/855,185 entitled “Therapeutic Compression Apparatus” filed on Aug. 12, 2010 and issued as U.S. Pat. No. 9,033,906, the entire contents of which are hereby incorporated herein by reference for all purposes.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2017/048241 | 8/23/2017 | WO | 00 |
| Number | Date | Country | |
|---|---|---|---|
| 62378581 | Aug 2016 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 12855185 | Aug 2010 | US |
| Child | 13444600 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 13444600 | Apr 2012 | US |
| Child | 16328718 | US |
