FIELD OF THE INVENTION

The present invention pertains to a pneumatic therapeutic device, and specifically to a vein thrombosis preventing and/or treating pneumatic device.

BACKGROUND OF THE INVENTION

For certain types of patient care, air support patient beds have been in use for a considerable period of time. For example air support beds have been found to provide considerable patient benefit. Beds of this character, however, have a number of significant drawbacks which, in many cases, have given hospitals, rest homes and other facilities cause for concern. For example, in many cases for patient comfort and safety, it is absolutely necessary that the air sac or air cell patient support devices remain inflated at all times. In most cases, it is quite necessary that the air sacs remain inflated within a preset pressure range to provide sufficient patient/air sac contact for even distribution of forces to the patient such that forces against any part of the patient's body remain sufficiently low that pressure lesions are unlikely.

In the event the air pressure in the air sacs of an air support bed is too low, the fabric material forming the air sacs tends to wrap around the patient to an excessive extent, thus preventing ambient air form reaching a good portion of the patient's body. In this case, there is a significant tendency for the patient to perspire heavily in areas where this wrap-around effect occurs. Continuous excessive perspiration can maintain excessive moisture present at the patient's skin for extended periods of time, thus adversely affecting the comfort and eventual recovery of the patient. This wrap-around effect also tends to force the shoulders of the patient toward one another, developing a condition which can be quite uncomfortable to the patient and causes spinal trauma. Obviously, the greater the contact between the patient and the material of the air sacs, the lower the mechanical pressure between the air sac material and the contact body surface area of the patient. Though softer air sacs effectively retard the development of pressure lesions, there is an optimum pressure range for each patient which establishes a balance between protection from pressure lesions and retarding excessive perspiration. It is known that this condition may be controlled or alleviated by applying intermittent pressure to a patient's legs to assist in blood circulation (venous return). Many devices have been proposed, including compression boots and other inflation tube devices, but heretofore all of the proposed solutions have been complex, or bulky, or both, and in each case, certainly not portable and self-contained.

US Patent 6290662 ('662) teaches an entirely self-contained, patient-worn apparatus for deep vein thrombosis (DVT) prophylaxis, and other conditions including an inflatable/deflatable bladder disposed against an extremity such as the upper calf, foot, or hand of a patient, or within a cast. An inelastic member is preferably used to fully enclose the bladder and body part, such that compressive forces are directed substantially entirely against the body part of the patient when the bladder expands, thereby conserving the power and reducing the volume of pneumatic compression required to operate the device. Given this conservation of energy, the invention may be battery operated from a source immediately proximate to the bladder arrangement, enabling the entire device to be self-contained and, in fact, worn by the patient. The reduced volume also allows the use of miniaturized components including the compressor motor and compressor.

The following disadvantages and drawbacks however are notable in '662. The aforesaid apparatus does not comprise a disposable member embracing patient's limb. In terms of hygiene it is preferable to use disposable members in most situations. According to the description of the invention inflatable bladder embraces the limb creating a non-concentrated pressure pattern. Being disposed inside the inelastic member, the inflatable bladder affects overall surface of the embraced limb.

A long felt and unmet need therefore exists to provide a pneumatic therapeutic system for preventing DVT with disposable members, made of hygienic materials.

The FlowMedic company (www.flowmedic.com) manufactures devices utilizing mechanical compression to improve blood flow in the lower limbs. The system tugs and releases a disposable sleeve placed around the calf muscle, thus exerting repetitive cycles of external pressure build-up on the tissue, and a subsequent release. The pressure exerted depends upon the Flowmedic device tugging and shortening the strap surrounding the calf and then releasing it. The pressure that can be exerted in this way is distributed over overall embraced surface of limb. Therefore, it is a long felt need is to provide a means for exerting pressure at the gastocnemius or calf surface to render compression methods for increasing blood flow more effective.

SUMMARY OF THE INVENTION

It is one object of the present invention to disclose a pneumatic therapeutic device (PTD) for preventing and/or treating deep vein thrombosis (DVT). The device comprises:

a. at least one inflatable bladder adapted to be inflated and deflated;

b. a controller adapted to vary a temporal profile of pressure provided to the bladder according to a predetermined protocol;

c. a sleeve adapted to embrace a calf portion of a limb, the at least one inflatable bladder is adapted to be mechanically connected to the sleeve via attaching means; and,

It is within the scope of the present invention that the sleeve consists of at least two portions: (i) a sufficiently elastic portion; and (ii) an inelastic portion; the inelastic portion comprises the at least one inflatable bladder, and the elastic portion is adapted to be stretched as a result of the inflation of the inflatable bladder on the calf portion, such that the a pushing force is actuated on the calf portion and the blood circulation is increased in the limb.

It is another object of the present invention to disclose a pneumatic therapeutic device (PTD) as defined above, wherein the sleeve is furnished with a fastener adapted to tightly attach a lower portion of the sleeve to the calf portion.

It is another object of the present invention to disclose a pneumatic therapeutic device (PTD) as defined above, wherein the sleeve is furnished with a fastener adapted to tightly attach an upper portion of the sleeve to the calf portion.

It is another object of the present invention to disclose a pneumatic therapeutic device (PTD) as defined above, wherein the device further comprises a sleeve adapted for releasably embracing patient's plantar surface of foot and a second bladder attachable to a portion of the sleeve adjacent to the plantar surface; the bladder is pneumatically connected to the inflating means.

It is another object of the present invention to disclose a pneumatic therapeutic device (PTD) as defined above, wherein the sleeve is a single use article. It is another object of the present invention to disclose a pneumatic therapeutic device (PTD) as defined above, wherein the sleeve is disposable and single-use.

It is another object of the present invention to disclose a pneumatic therapeutic device (PTD) as defined above, wherein the bladder is disposable.

It is another object of the present invention to disclose a pneumatic therapeutic device (PTD) as defined above, wherein the sleeve and the bladder are uniquely secured and attached to complete the system in situ.

It is another object of the present invention to disclose a pneumatic therapeutic device (PTD) as defined above, wherein detaching the sleeve from the bladder results in destruction of the sleeve to the extent that the sleeve is rendered unusable a second time.

It is another object of the present invention to disclose a method for preventing and/or treating DVT, the method comprising the step of:

a. providing the pneumatic therapeutic device according to claim 1 , preprogrammed to an effective therapeutic regime;

b. fastening the sleeve onto the calf, the sleeve comprising the bladder;

c. inflating and deflating the bladder by the inflating means in accordance with preprogrammed temporal pressure profile for effective period of time;

d. unfastening the bladder from the sleeve; and

e. unfastening the sleeve from the calf;

It is within the scope of the present invention that the sleeve consists of at least two portions: (i) a sufficiently elastic portion; and (ii) an inelastic portion; the inelastic portion comprises the at least one inflatable bladder, and the elastic portion is adapted to be stretched as a result of the inflation of the inflatable bladder on the calf portion, such that the a pushing force is actuated on the calf portion and the blood circulation is increased in the limb.

It is another object of the present invention to disclose the method for preventing and/or treating DVT as defined above, wherein the fastening the sleeve is performed by the lower fastener.

It is another object of the present invention to disclose the method for preventing and/or treating DVT as defined above, wherein the fastening the sleeve is performed by the upper fastener.

It is another object of the present invention to disclose the method for preventing and/or treating DVT as defined above, wherein the fastening the sleeve is performed by the lower and upper fasteners. It is another object of the present invention to disclose the method for preventing and/or treating DVT as defined above, wherein the fastening the sleeve further comprises fastening the sleeve to the plantar area of the foot.

It is another object of the present invention to disclose the method for preventing and/or treating DVT as defined above, wherein the fastening the bladder further comprises fastening the second bladder to the plantar area of the foot.

BRIEF DESCRIPTION OF THE DRAWINGS

In order to understand the invention and to see how it may be implemented in practice, a plurality of embodiments is adapted to now be described, by way of non-limiting example only, with reference to the accompanying drawings, in which

Fig. la is a schematic view of the calf DVT therapeutic device in the inflated state;

Fig. lb is a schematic view of the calf DVT therapeutic device in the deflated state;

Fig. 2a is a schematic diagram of a DVT therapeutic device in an active phase;

Fig. 2b is an exploded schematic diagram of a DVT therapeutic device in an active phase;

Fig. 2c is a schematic diagram of a DVT therapeutic device in a passive phase;

Fig. 2d is an exploded schematic diagram of a DVT therapeutic device in a passive phase;

Fig. 3 is a graph of the influence the pneumatic stimulation on the rate of blood circulation.

Fig. 4a is a schematic cross-section view the calf DVT therapeutic device according to some embodiments;

Fig. 4a is a schematic illustration of the calf DVT therapeutic device according to some embodiments;

Fig. 4b is a schematic illustration of the calf DVT therapeutic device according to some embodiments;

Fig. 4c is a schematic illustration of the calf DVT therapeutic device according to some embodiments;

Fig. 4d is a schematic illustration of the calf DVT therapeutic device according to some embodiments; Fig. 4e is a schematic illustration of view the calf DVT therapeutic device according to some embodiments;

Fig. 4f is a schematic illustration of the calf DVT therapeutic device according to some embodiments;

Fig. 5 is a schematic of the autonomous calf DVT therapeutic device;

DETAILED DESCRIPTION OF THE INVENTION

The following description is provided, alongside all chapters of the present invention, so as to enable any person skilled in the art to make use of said invention and sets forth the best modes contemplated by the inventor of carrying out this invention. Various modifications, however, is adapted to remain apparent to those skilled in the art, since the generic principles of the present invention have been defined specifically to provide a pneumatic therapeutic system for preventing and treating bedsores and stimulating patient's blood cycling.

The term "bedsores, also known as pressure ulcers or decubitus, hereinafter refers to lesions caused by unrelieved pressure to any part of the body, especially portions over bony or cartilaginous areas. Although completely treatable if found early, without medical attention, bedsores can become life-threatening.

The following stages of disease; are defined:

Stage I is the most superficial, indicated by redness that does not subside after pressure is relieved. This stage is visually similar to reactive hyperemia (a technical term for excessive redness) seen in skin after prolonged application of pressure. Stage I pressure ulcers can be distinguished from reactive hyperemia in two ways: a) reactive hyperemia resolves itself within 3/4 of the time pressure was applied, and b) reactive hyperemia blanches when pressure is applied, whereas a Stage 1 pressure ulcer does not. The skirt may be hotter or cooler than normal, have an odd texture, or perhaps be painful to the patient. Although easy to identify on a light-skinned patient, ulcers on darker-skinned individuals may show up as shades of purple or blue in comparison to lighter skin tones.

Stage II is damage to the epidermis extending into, but no deeper than, the dermis. In this stage, the ulcer may be referred to as a blister or abrasion. Stage III involves the full thickness of the skin, extending into, but not through, the subcutaneous tissue layer. This layer has a relatively poor blood supply and can be difficult to heal. At this stage, there may be undermining : that makes the wound much larger than it may seem on the surface.

Stage IV pressure ulcer is the deepest, extending into the muscle, tendon or even bone.

Unstageable pressure ulcers are covered with dead cells, or eschar and wound exudate, so the depth cannot be determined.

The term "Deep-vein thrombosis, also known as deep-venous thrombosis or DVT and colloquially as economy class syndrome) hereinafter refers to the formation of a blood clot ("thrombus") in a deep vein. It commonly . affects the leg veins, such as the femoral vein or the popliteal vein or the deep veins of the pelvis. Occasionally the veins of the arm are affected (known as Paget-Schrotter disease). Thrombophlebitis is the more general class of pathologies of this kind. There is a significant risk of the thrombus embolizing and traveling to the lungs causing a pulmonary embolism.

The term "degradably performed" hereinafter refers to an action wherein two elements o the invention, such as the bladder and sleeve are seperated after fastening in such a way as to damage either or both of the elements such that at least one element is unusable.

It is acknowledged that a core feature of the invention is to provide a device and method for preventing and treating Deep Vein Thrombosis by providing slow peristaltic pressure pulsations to the lower limbs in order to prevent pooling of blood in the lower extremities. Λ protocol is provided which is both effective for the aforementioned purpose, but also minimally disturbing to the patient. The protocol is so designed as to enable ease of habituation by the patient, thereby enabling the patient to sleep during treatment. Patient compliance is thereby encouraged.

The present invention discloses a pneumatic therapeutic device (PTD) for preventing and/or treating deep vein thrombosis (DVT). The device comprises the following components:

a. at least one inflatable bladder adapted to be inflated and deflated;

b. a controller adapted to vary a temporal profile of pressure provided to the bladder according to a predetermined protocol;

c. a sleeve adapted to embrace a calf portion of a limb, the at least one inflatable bladder is adapted to be mechanically connected to the sleeve via attaching means; and, It is within the scope of the present invention that the sleeve consists of at least two portions: (i) a sufficiently elastic portion; and (ii) an inelastic portion; the inelastic portion comprises the at least one inflatable bladder, and the elastic portion is adapted to be stretched as a result of the inflation of the inflatable bladder on the calf portion, such that the a pushing force is actuated on the calf portion and the blood circulation is increased in the limb.

Reference is now made to Figs la and lb, illustrating blood circulation in the lower limbs as facilitated by embodiments of the invention. The DVT device 16 comprises a single-use sleeve 42 embracing a human leg 40 and an inflatable bladder 44 connected to inflating device 22 (not shown) by means of pipe 26 attachable to the sleeve 42. Sleeve 42 embraces an anticnemion (anterior border of tibia) of the patient's leg 40. An inflated bladder 44 being attached to the sleeve 42 is periodically inflated and deflated. In inflated state the bladder 44 presses to a back surface of the anticnemion and stimulates blood to move upward along to a vein, and the elastic portion of the sleeve is stretched as a result of the inflation of the, such that the a pushing force is actuated on the calf portion and the blood circulation is increased in the limb.

It is acknowledged that the embodiments of the invention disclosed herein comprise disposable sleeves and disposable bladders. It is further acknowledged that embodiments of the invention are disclosed wherein neither aforementioned sleeves nor aforementioned bladders can be attached to the target limb, but are rendered attachable by uniquely fastening to each other in a configuration providing appropriate enclosure of the device on the target limb. It is further acknowledged that the embodiments of the invention disclosed herein comprise arrangements such that the sleeve and bladder are uniquely secured to complete the system in situ.

The sleeve only circumscribes a portion of the target limb. A unit comprising the inflatable bladder is required to complete the correct disposition of the system on the target limb. Unique single use fasteners are provided to attach the aforementioned elements. The fasteners and the material of the sleeve are so designed such that detachment of the bladder unit after a session results in the destruction of the sleeve, rendering the sleeve unusable a second time. This is a useful feature for the sake of hygiene. Means of attachment may comprise Velcro, poppers, straps, adhesive tapes and other means.

Reference is now made to Figs 2a - 2d, demonstrating an operating principle of the DVT- device in accordance with current invention. The sleeve 42 consists of two portions: a sufficiently elastic portion and an inelastic portions. It will be shown below, that an elastic material bladder is inelastically attached to the elastic portion of the sleeve 42. The elastic bladder exerting the calf 40 is undoubtedly more effective therapy in comparison with any known in the art elastic bladder. Figs 2a and 2b show an inflated state of the bladder, Figs 2c and 2d - deflated state.

The inflatable bladder is held tightly against the calf and is inflated in a manner so as to exert high pressure against the calf. Intermittent slow peristaltic pressure pulsations and compressions are provided by this device thereby providing increased blood circulation through the limbs useful in preventing Deep Vein Thrombosis. The protocols for the aforementioned slow peristaltic pressure pulsations and compressions allow ease of habituation, and the device can be worn and used while the patient is walking as well as stationary and even while asleep.

According to some embodiments of the present invention, the device of the present invention may be combined with a vibrator which may be attached an enforcing strap vibrator may provide an additional stimulation of blood circulation in a human leg.

Reference is now made to Fig. 3 which schematically illustrates the pneumatic stimulation of the blood circulation which increases the velocity of the blood flow up to three times. In Fig. 3 points 505 and 510 of a curve 500 corresponds to a rate of blood amounts before and after the pneumatic stimulation. A curve 530 shows dynamics of the blood circulation in the limb. A time period 520 is a pause between stimulation cycles.

Reference is now made to Figs 4a and 4b, the single-use sleeve 42 is furnished with a single- use fabric hook-and-loop fastener 72. Similar, the inflatable bladder 44 is attached to sleeve 42 by means single-use fabric hook-and-loop fastener 70. Figs 4a and 4b illustrate the MPT- DVT 16 in inflated and deflated state, respectively.

Reference is now made to Figs 4a and 4b, the inflatable bladder 44 can be releasably attached on an internal surface of sleeve 42 by means of a single-use fabric hook-and-loop fastener 76. Figs 4a and 4b illustrate an assembly in inflated and deflated state, respectively.

Reference is now made to Figs 4a-h in which a specific embodiment of the present invention is shown. According to this figure, the single-use sleeve 42 is shown in open ended manner before use (Fig. 4c), in close ended manner (Fig. 4a-b), and with torn fabric hook-and-loop fastener 82 (Fig. 4f). The sleeve 42 is furnished with a tearable fabric hook-and-loop fastener 82 releasably attached to sleeve 42 by means of an adhesive layer 80. The fastener 82 fixates the sleeve 42 on the leg 40. A force necessary for opening the sleeve 42 after use is greater than a force needed to embracing the leg 40. The use of commonly available appropriate adhesives renders the sleeve 42 inapplicable for second use. As seen in Fig. l ie, after opening the sleeve 42 the fastener layer 82 is left at the opposite end portion of the sleeve 42.

Reference is now made to 5, showing the sleeve 42 and the bladder 44 adapted for releasably attaching to the sleeve 42. In accordance with one of the embodiments of the current invention the inflating device 22 is autonomous and is attached to the bladder 44. Attaching the bladder 44 to the sleeve 42 is provided by grip pawls 90 attached to the bladder and mortises 92 disposed on the sleeve 42. The grip pawls 90 fit into the mortises 92 and secure the bladder 44 to the sleeve 42. The sleeve 42 additionally comprises an elastic area 94 enabling more effective impact of the bladder 44 on the leg 40.

The aforementioned controller is adapted to vary the pressure profile in a preprogrammed manner in accordance with sensor signals such that the therapeutic system prevents and/or treats bedsores and stimulates patient's blood cycling, according to a preprogrammed and effective therapeutic regime. The method further comprises attaching a plurality of the bladders to the hospital bed; placing a patient onto the bladders; inflating and deflating the plurality of the bladders by the inflating means in accordance with a preprogrammed temporal pressure profile for effective period of time; moving said patient off said bladders; further wherein the inflating and deflating of the bladders are varied according to patient's body load applied to the bladders.