Patent Grant
7591796
The present invention relates to medical devices for applying pressure to a region of a body surface. More particularly, the present invention relates to medical devices that use a pressure sleeve and a pressure accumulator to apply pressure to a region of a body surface.
The present invention relates to systems for applying compressive pressures against a patient's limb, specifically to a miniaturized, automatic portable battery and/or main power supply operated ambulant system.
Various conventional compression devices are known for applying compressive pressure to a patient's limb. These types of devices are used to assist in a large number of medical indications, mainly the prevention of deep vein thrombosis (DVT), vascular disorders, reduction of edemas, and the healing of wounds. Prior art devices are typically divided into two main segments: 1) a hospital segment, in which the conventional compression devices are used mainly for the prevention of DVT and 2) a home segment, in which the conventional compression devices are mainly used to treat severe lymphedema. Although showing high clinical efficacy in clinical studies in treating the above clinical indications, the conventional compression devices share many disadvantages that severely hamper their clinical out come in real life situations
For example, the conventional compression devices use a conventional main power supply (wall outlet), and thus impose confinement upon the patient during the long periods of treatment e.g.: in DVT prevention after surgeries, the patients should be on therapy continuously from before the operation until discharge on a 24/7 basis. Confinement to the bed for receiving continuous treatment with a conventional device is impractical and is hardly ever achieved. Moreover the need to stay lying in bed for long periods of time delays recuperation, can lead to the development of pressure ulcers, and is contra-indicated to good medical practice.
The pump unit of the conventional compression device is heavy (5-15 pounds), which makes it hard to maneuver and place in the vicinity of the patients. The pump unit is also big and thus creates a storage problem, specifically in hospitals, in which tens and hundreds of units are stationed, usually in a special storage room.
The sleeve of the conventional compression device is big and ungainly, and thus restricts the movement of the limb it encompasses and imposes discomfort. In addition, the use of multiple cells demands the use of multiple conduits (usually one for each cell) making the whole system more cumbersome and harder to maneuver. Moreover, data corresponding to the pressure and compression cycles of the conventional compression systems has to be manually entered into the system by the clinical staff each time the system is turned ON. Furthermore, since the error detecting mechanism of the conventional systems shuts OFF the system each time an error is detected, the system needs to be manually restarted by the clinical staff, thereby requiring the clinical staff to manually re-enter the data corresponding to the pressure and compression cycles. In other words, in view of the need to manually enter the data corresponding to the pressure and compression cycles upon each start-up of the compression system and in view of the shutting down of the system upon error detection, with the accompanying re-entry of data, the conventional compression systems are overly dependent upon clinical staff for operation, thereby unduly imposing on the workload of the clinical staff.
All of the aforementioned disadvantages result in poor patient and therapist (mainly nurses) compliance and compliant. Clinical studies have proven that daily compliance of the systems is less then 50% resulting in far below expectation clinical outcomes compared to a continuous treatment (Prophylaxis against DVT after total knee arthroplasty, by Geoffrey H. Westrich, the Journal of bone and joint surgery vol. 78-A, June 1996. Why does prophylaxis with external pneumatic compression for DVT fail, by Anthony J. Comerota, the American journal of surgery vol. 164 September 1992 and others).
The conventional compression devices need to be as big and use the conventional electrical outlets for the power supply as conventional compression devices use the same basic shape of inflatable bladders in the sleeves. These conventional compression devices use substantial amounts of fluid (usually air) in order to inflate the sleeve and create the desired pressure at a timely manner (between 0.25-10 seconds per chamber). As a consequence, the conventional compression devices need large compressors that require high current supply, which forces the connection to the electrical outlets for power supply. The same follows with respect to the need for relatively large components in the conventional compression devices, such as solenoids, air conduits etc.
The need for a small ambulant/portable aesthetic device has long been recognized by the industry, as evident from prior patents of leading companies in this field; such as, U.S. Pat. Nos. 5,795,312; 5,626,556; 4,945,905; and 5,354,260, and 6,290,662 as well as EP 0861652, and others; are concerned with using less air to inflate the sleeves, easier handling, and all of the other disadvantages previously discussed.
One proposed solution introduced the use of foot pumps, another suggested an inelastic outer shell to limit the inflation of the cells and others proposed solutions focused upon improving the pumps (flow rate, power consumption, etc.) and not upon improving the use of the pumped air that would enable one to accomplish the same pressures in the same timely manner and the same therapeutic goals using about a fraction of the volume of air that the conventional compression devices need.
As noted above, in many medical conditions it is desirable to apply pressure to a region of the body surface. Conventionally, this is accomplished by fixing one or more individually inflatable cells to the body surface. When the cells are inflated, a pressure is applied to the body surface in contact with the cell. When the cell is deflated, the pressure is relieved. The cells are usually incorporated into a sleeve that is placed around a body limb to be treated. The limb may be, for example, a leg, an arm, a hand, a foot, or the trunk.
The cells may be toroidal in shape when inflated so as to completely surround the limb. A cell may be maintained in an inflated state for a prolonged period of time in order to apply prolonged pressure to the underlying body region. Alternatively, a cell may be inflated and deflated periodically so as to apply intermittent pressure to the underlying body region. A sleeve having one or more individually inflatable cells will be referred to herein as a pressure sleeve.
The console 615 further comprises a processor 619 that controls the state of each of the valves (605a, 605b, and 605c) so as to execute a predetermined temporo-spatial array of inflation of the cells. For example, in one application the cells are inflated peristaltically so that one cell is first inflated, while the other cells are deflated. As illustrated in
The console 615 has a housing 620 containing the processor 619, the conduit 607 and the valves (605a, 605b, and 605c). The compressor 602 may be located within the housing of the console 615 as shown in
In the conventional compression system as shown in
As illustrated in
The conventional compression system shown in
Systems of the type shown in
As illustrated in
Therefore, it is desirable to provide a compression system that is small, ambulant, and portable. It is also desirable to provide a compression system that provides patients with continuous 24/7 treatment and freedom of movement. Furthermore, it is desirable to provide a compression system that is suitable for home use and can be stored easily. Moreover, it is desirable to provide a compression system that allows a user to engage in social activities during treatment. Lastly, it is desirable to provide a compression system that is includes a pressure accumulator that is small, ambulant, and portable.
A first aspect of the present invention is a compression system for applying therapeutic pressure to a limb of a body. The compression system includes a pressure sleeve; a compression system console, pneumatically connected to the pressure sleeve, having a controller to provide controlled pressurized fluid to the pressure sleeve; and a pressure accumulator, flexibly tethered and pneumatically connected to the compression system console, to provide controlled pneumatic compression.
A second aspect of the present invention is a pressure sleeve. The pressure sleeve includes an integral pressure accumulator and an inflatable cell operatively pneumatically connected to the integral pressure accumulator.
A third aspect of the present invention is a compression system for applying therapeutic pressure to a limb of a body. The compression system includes a pressure sleeve; a compression system console, pneumatically connected to the pressure sleeve, having a controller to provide controlled pressurized fluid to the pressure sleeve; and a pressure accumulator integral to the pressure sleeve, pneumatically connected to the compression system console, to provide controlled pneumatic compression.
A fourth aspect of the present invention is a therapeutic foot device. The therapeutic foot device includes a pressure sleeve; a sole member; and a pressure accumulator provided in the sole member and operatively pneumatically connected to the pressure sleeve.
A fifth aspect of the present invention is a therapeutic foot system. The therapeutic foot system includes a pressure sleeve; a compression system console, pneumatically connected to the pressure sleeve, having a controller to provide controlled pressurized fluid to the pressure sleeve; a sole member; and a pressure accumulator provided in the sole member and operatively pneumatically connected to the pressure sleeve.
A sixth aspect of the invention is a therapeutic foot device. The therapeutic foot device includes a foot pressure sleeve and a pressure accumulator operatively pneumatically connected to the pressure sleeve. The pressure sleeve includes an inflatable cell. The inflatable cell includes at least two intra-cell compartments, the intra-cell compartments being confluent.
A seventh aspect of the present invention is a therapeutic foot system. The therapeutic foot system includes a pressure sleeve; a compression system console, pneumatically connected to the pressure sleeve, having a controller to provide controlled pressurized fluid to the pressure sleeve; and a pressure accumulator, operatively pneumatically connected to the pressure sleeve and flexibly tethered and pneumatically connected to the compression system console, to provide controlled pneumatic compression.
An eighth aspect of the present invention is a therapeutic pressure system. The therapeutic pressure system includes a pressure sleeve and a compression system console, pneumatically connected to the pressure sleeve, having a controller to provide controlled pressurized fluid to the pressure sleeve. The controller, upon entering a first mode, identifies a type of the pressure sleeve connected to the compression system console.
A ninth aspect of the present invention is a method of providing therapy with a pressure sleeve and a compression system console, pneumatically connected to the pressure sleeve, having a controller and a plurality of air conduit terminals to provide controlled pressurized fluid to the pressure sleeve. The method polls each air conduit terminal to determine a state thereof; determines automatically a type of pressure device connected to an air conduit terminal from the polling; determines automatically a treatment sequence and pressures based on the types of pressure devices connected to the air conduit terminals; and applies therapeutic pressure to a patient based on the determined treatment sequence.
A tenth aspect of the present invention is a method of providing therapy with a pressure sleeve and a compression system console, pneumatically connected to the pressure sleeve, having a controller and a plurality of air conduit terminals to provide controlled pressurized fluid to the pressure sleeve. The method polls each air conduit terminal to determine a state thereof; determines automatically a type of pressure device connected to an air conduit terminal from the polling; determines automatically a pressure to be applied based on the types of pressure devices connected to the air conduit terminals; and applies therapeutic pressure to a patient based on the determined pressure.
An eleventh aspect of the present invention is a method of providing therapy with a pressure sleeve and a compression system console, pneumatically connected to the pressure sleeve, having a controller and a plurality of air conduit terminals to provide controlled pressurized fluid to the pressure sleeve. The method polls each air conduit terminal to determine a state thereof; determines automatically a type of pressure device connected to an air conduit terminal from the polling; determines automatically a treatment sequence based on the types of pressure devices connected to the air conduit terminals; and applies therapeutic pressure to a patient based on the determined treatment sequence.
A twelfth aspect of the present invention is a device for applying pressure to a body limb having a primary axis. The device includes first and second inflatable cells, each of the first and second inflatable cells including at least three intra-cell compartments, the intra-cell compartments being confluent, each compartment being elongated along a longitudinal axis and being substantially rectangular in shape when deflated and substantially cylindrical in shape when inflated, the first and second inflatable cells being longitudinally adjacent each other and arranged coaxially with respect to the primary axis of the limb when engaged with a limb, the first and second inflatable cells each including inner and outer shells of durable flexible material, the inner and outer shells being bonded together to form a perimetric bond about a perimeter of the inflatable cell, the perimetric bond defining the inflatable cell as a volume between the inner and outer shells and within the perimetric bond, the inner and outer shells being further bonded together to form a plurality of compartmental bonds within the inflatable cell bond, the plurality of compartmental bonds defining at least three intra-cell compartments, the perimetric cell bond of an inflatable cell including first and second perimetric cell bond portions, the first and second perimetric cell bond portions being substantially parallel thereto, wherein a portion of the compartmental bonds partly extending between the first and second perimetric cell bond portions, the compartmental bonds extending between the first and second perimetric cell bond portions including perforations to allow for confluent air flow between adjacent intra-cell compartments within a cell, the adjacent intra-cell compartments within a cell being spatially fixed relative to each other such that upon inflation of the adjacent intra-cell compartments within the cell, the cell becomes circumferentially constricted, the first and second inflatable cells being non-confluent such that that the first and second inflatable cells are separately inflatable; means for laterally coupling outermost compartments so as to form a sleeve such that the sleeve has a first circumference value when the intra-cell compartments are deflated and a second circumference value when the intra-cell compartments are inflated, the second circumference value being less than the first circumference value so as to provide for circumferential constriction, the first circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and deflated, the second circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and inflated; and a compression system console including control means for determining the temporo-spatial regime of cell inflation.
Another aspect of the present invention is an automatic portable ambulant system for applying pressure to a body limb. The automatic portable ambulant system includes a sleeve including first and second inflatable cells, the first and second inflatable cells each including at least three intra-cell compartments, the intra-cell compartments being confluent, the intra-cell compartments being elongated along a longitudinal axis and being substantially rectangular in shape when deflated and substantially cylindrical in shape when inflated, the first and second inflatable cells being longitudinally adjacent to each other so as to be adapted to be arranged coaxially with respect to a primary axis of a body limb, the first and second inflatable cells each including inner and outer shells of durable flexible material, the inner and outer shells being bonded together to form a perimetric bond about a perimeter of the inflatable cell, the perimetric bond defining the inflatable cell as a volume between the inner and outer shells and within the perimetric bond, the inner and outer shells being further bonded together to form a plurality of compartmental bonds within the inflatable cell bond, the plurality of compartmental bonds defining at least three intra-cell compartments, the perimetric cell bond including first and second perimetric cell bond portions, the first and second perimetric cell bond portions being substantially parallel thereto, wherein a portion of the compartmental bonds partly extending between the first and second perimetric cell bond portions, the compartmental bonds extending between the first and second perimetric cell bond portions including perforations to allow for confluent air flow between adjacent intra-cell compartments within a cell, the first inflatable cell becoming circumferentially constricted when the intra-cell compartments of the first inflatable cell are inflated, the second inflatable cell becoming circumferentially constricted when the intra-cell compartments of the second inflatable cell are inflated, the first and second inflatable cells being non-confluent such that the first and second inflatable cells are separately inflatable; means for laterally coupling outermost compartments so as to form a sleeve such that the sleeve has a first circumference value when the intra-cell compartments are deflated and a second circumference value when the intra-cell compartments are inflated, the second circumference value being less than the first circumference value so as to provide for circumferential constriction, the first circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and deflated, the second circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and inflated; and a portable hand-held console unit for providing pressurized air to any one or more selected cells of the sleeve via a conduit, said console unit including a control unit for determining the sequence of cell inflation and deflation.
A further aspect of the present invention is a method for immobilizing a fractured bone in a limb. The method couples outermost intra-cell compartments of a sleeve around a limb, the sleeve comprising at least one inflatable cell, each including at least three intra-cell compartments, the intra-cell compartments being confluent and elongated along a longitudinal axis and being substantially rectangular in shape when deflated and being substantially cylindrical in shape when inflated, the longitudinal axes of the compartments substantially aligning with the primary axis of the limb, wherein the inflatable cells each comprise inner and outer shells of durable flexible material, the inner and outer shells being bonded together about a perimetric cell bond to define the inflatable cell therebetween, the inner and outer shells being further bonded together along compartmental bonds within the perimetric cell bond to define the plurality of intra-cell compartments, wherein the perimetric cell bond includes upper and lower perimetric cell bonds extending substantially in a lateral direction, and left and right perimetric cell bonds extending substantially in the longitudinal direction, and wherein the compartmental bonds partly extend between the upper and lower perimetric cell bonds, wherein the compartmental bonds include perforations to allow for confluent air flow between compartments within a cell, compartments within a cell being spatially fixed relative to each other such that upon inflation of a cell; and intermittently inflates one of the first or second inflatable cells to apply pressure to the limb by circumferentially constricting the intermittently inflated cell, the cell having a first circumference value when the intra-cell compartments are deflated and a second circumference value when the intra-cell compartments are inflated, the second circumference value being less than the first circumference value so as to provide for circumferential constriction, the first circumference value being a length between the outermost intra-cell compartments of the cell when laterally uncoupled and deflated, the second circumference value being a length between the outermost intra-cell compartments of the cell when laterally uncoupled and inflated.
Another aspect of the present invention is a device for applying pressure to a body limb having a primary axis. The device includes first and second inflatable cells, the first and second inflatable cells each including at least three intra-cell compartments, the intra-cell compartments being confluent, the intra-cell compartments being elongated along a longitudinal axis and being substantially rectangular in shape when deflated and substantially cylindrical in shape when inflated, the first and second inflatable cells being adjacent each other and arranged coaxially with respect to the primary axis of the limb, the first and second inflatable cells each including inner and outer shells of durable flexible material, the first and second inflatable cells each including inner and outer shells of durable flexible material, the inner and outer shells being bonded together to form a perimetric bond about a perimeter of the inflatable cell, the perimetric bond defining the inflatable cell as a volume between the inner and outer shells and within the perimetric bond, the inner and outer shells being further bonded together to form a plurality of compartmental bonds within the inflatable cell bond, the plurality of compartmental bonds defining at least three intra-cell compartments, the perimetric cell bond including first and second perimetric cell bond portions, the first and second perimetric cell bond portions being substantially parallel thereto, wherein a portion of the compartmental bonds partly extending between the first and second perimetric cell bond portions, the compartmental bonds extending between the first and second perimetric cell bond portions including perforations to allow for confluent air flow between adjacent intra-cell compartments within a cell, the first inflatable cell becoming circumferentially constricted when the intra-cell compartments of the first inflatable cell are inflated, the second inflatable cell becoming circumferentially constricted when the intra-cell compartments of the second inflatable cell are inflated, the first and second inflatable cells being non-confluent such that the first and second inflatable cells are separately inflatable; means for laterally coupling outermost compartments so as to form a sleeve such that the sleeve has a first circumference value when the intra-cell compartments are deflated and a second circumference value when the intra-cell compartments are inflated, the second circumference value being less than the first circumference value so as to provide for circumferential constriction, the first circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and deflated, the second circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and inflated; and a compression system console including control means for determining a temporo-spatial regime of cell inflation.
A further aspect of the present invention is an automatic portable ambulant system for applying pressure to a body limb. The system includes a sleeve including first and second inflatable cells, the first and second inflatable cells each including at least three intra-cell compartments, the intra-cell compartments being confluent, the intra-cell compartments being elongated along a longitudinal axis and being substantially rectangular in shape when deflated and substantially cylindrical in shape when inflated, the first and second inflatable cells being adjacent each other and arranged coaxially with respect to the primary axis of the limb, the first and second inflatable cells each including inner and outer shells of durable flexible material, the inner and outer shells being bonded together to form a perimetric bond about a perimeter of the inflatable cell, the perimetric bond defining the inflatable cell as a volume between the inner and outer shells and within the perimetric bond, the inner and outer shells being further bonded together to form a plurality of compartmental bonds within the inflatable cell bond, the plurality of compartmental bonds defining at least three intra-cell compartments, the perimetric cell bond including first and second perimetric cell bond portions, the first and second perimetric cell bond portions being substantially parallel thereto, wherein a portion of the compartmental bonds partly extending between the first and second perimetric cell bond portions, the compartmental bonds extending between the first and second perimetric cell bond portions including perforations to allow for confluent air flow between adjacent intra-cell compartments within a cell, the first inflatable cell becoming circumferentially constricted when the intra-cell compartments of the first inflatable cell are inflated, the second inflatable cell becoming circumferentially constricted when the intra-cell compartments of the second inflatable cell are inflated, the first and second inflatable cells being non-confluent such that the first and second inflatable cells are separately inflatable; means for laterally coupling the outermost intra-cell compartments within a cell so as to form a sleeve such that the sleeve has a first circumference value when the intra-cell compartments are deflated and a second circumference value when the intra-cell compartments are inflated, the second circumference value being less than the first circumference value so as to provide for circumferential constriction, the first circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and deflated, the second circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and inflated; and a portable hand-held compression system console for providing pressurized air to inflate selected cells of the sleeve via a conduit. The compression system console includes a control unit for determining the sequence of cell inflation and deflation.
A still further aspect of the present invention is a device for applying pressure to a body limb having a primary axis. The device includes an inflatable cell; the inflatable cell including at least two intra-cell compartments, the intra-cell compartments being confluent, each intra-cell compartment being elongated in a direction of the primary axis, the inflatable cell further including inner and outer shells of durable flexible material, the inner and outer shells being bonded together about a perimetric cell bond, the inner and outer shells being further bonded together along compartmental bonds within the perimetric cell bond to define each intra-cell compartment, the perimetric cell bond including upper and lower perimetric cell bonds, the compartmental bonds partly extending between the upper and lower perimetric cell bonds, the compartmental bonds including perforations to allow for confluent air flow between adjacent intra-cell compartments within the cell, adjacent intra-cell compartments being spatially fixed relative to each other, such that upon inflation, the cell becomes circumferentially constricted, the inflatable cell having a first circumference value when the intra-cell compartments are deflated and a second circumference value when the intra-cell compartments are inflated, the second circumference value being less than the first circumference value so as to provide for circumferential constriction, the first circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and deflated, the second circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and inflated.
Another aspect of the present invention is a device for applying pressure to a body limb having a primary axis. The device includes an inflatable cell, the inflatable cell including at least two intra-cell compartments, the intra-cell compartments being confluent to allow for confluent air flow between adjacent intra-cell compartments within the cell, adjacent intra-cell compartments being spatially fixed relative to each other, such that upon inflation, the cell becomes circumferentially constricted, the inflatable cell having a first circumference value when the intra-cell compartments are deflated and a second circumference value when the intra-cell compartments are inflated, the second circumference value being less than the first circumference value so as to provide for circumferential constriction, the first circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and deflated, the second circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and inflated.
A further aspect of the present invention is an automatic portable ambulant system for applying pressure to a body limb. The system includes an inflatable cell, the inflatable cell including at least two intra-cell compartments, the intra-cell compartments being confluent, each compartment being elongated in a direction of the primary axis, the inflatable cell further including inner and outer shells of durable flexible material, the inner and outer shells being bonded together about a perimetric cell bond, the inner and outer shells being further bonded together along compartmental bonds within the perimetric cell bond to define each intra-cell compartment, the perimetric cell bond including upper and lower perimetric cell bonds, the compartmental bonds partly extending between the upper and lower perimetric cell bonds, the compartmental bonds including perforations to allow for confluent air flow between adjacent intra-cell compartments within the cell, adjacent intra-cell compartments being spatially fixed relative to each other, such that upon inflation, the cell becomes circumferentially constricted, the inflatable cell having a first circumference value when the intra-cell compartments are deflated and a second circumference value when the intra-cell compartments are inflated, the second circumference value being less than the first circumference value so as to provide for circumferential constriction, the first circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and deflated, the second circumference value being a length between the outermost intra-cell compartments of the sleeve when laterally uncoupled and inflated; and a portable hand-held compression system console including a control unit for determining a sequence of cell inflation and deflation.
Another aspect of the present invention is a device for applying pressure to a body limb having a primary axis. The device includes first and second inflatable cells, each of the first and second inflatable cells including at least three intra-cell compartments, the intra-cell compartments being confluent, each compartment being elongated along a longitudinal axis and being substantially rectangular in shape when deflated and substantially cylindrical in shape when inflated, the first and second inflatable cells being longitudinally adjacent each other and arranged coaxially with respect to the primary axis of the limb when engaged with a limb, the first and second inflatable cells each including inner and outer shells of durable flexible material, the inner and outer shells being bonded together to form a perimetric bond about a perimeter of the inflatable cell, the perimetric bond defining the inflatable cell as a volume between the inner and outer shells and within the perimetric bond, the inner and outer shells being further bonded together to form a plurality of compartmental bonds within the inflatable cell bond, the plurality of compartmental bonds defining at least three intra-cell compartments, the perimetric cell bond of an inflatable cell including first and second perimetric cell bond portions, the first and second perimetric cell bond portions being substantially parallel thereto, wherein a portion of the compartmental bonds partly extending between the first and second perimetric cell bond portions, the compartmental bonds extending between the first and second perimetric cell bond portions including perforations to allow for confluent air flow between adjacent intra-cell compartments within a cell, the adjacent intra-cell compartments within a cell being spatially fixed relative to each other such that upon inflation of the adjacent intra-cell compartments within the cell, the cell becomes circumferentially constricted, the first and second inflatable cells being non-confluent such that that the first and second inflatable cells are separately inflatable, the intra-cell compartments, while being inflated, substantially simultaneously expanding in a direction substantially normal to a surface of the limb and contracting in a direction substantially coaxially to the surface of the limb; means for laterally coupling outermost compartments so as to form a sleeve; and a compression system console including control means for determining a temporo-spatial regime of cell inflation.
Another aspect of the present invention is an automatic portable ambulant system for applying pressure to a body limb. The automatic portable ambulant system includes a sleeve including first and second inflatable cells, the first and second inflatable cells each including at least three intra-cell compartments, the intra-cell compartments being confluent, the intra-cell compartments being elongated along a longitudinal axis and being substantially rectangular in shape when deflated and substantially cylindrical in shape when inflated, the first and second inflatable cells being longitudinally adjacent to each other so as to be adapted to be arranged coaxially with respect to a primary axis of a body limb, the first and second inflatable cells each including inner and outer shells of durable flexible material, the inner and outer shells being bonded together to form a perimetric bond about a perimeter of the inflatable cell, the perimetric bond defining the inflatable cell as a volume between the inner and outer shells and within the perimetric bond, the inner and outer shells being further bonded together to form a plurality of compartmental bonds within the inflatable cell bond, the plurality of compartmental bonds defining at least three intra-cell compartments, the perimetric cell bond including first and second perimetric cell bond portions, the first and second perimetric cell bond portions being substantially parallel thereto, wherein a portion of the compartmental bonds partly extending between the first and second perimetric cell bond portions, the compartmental bonds extending between the first and second perimetric cell bond portions including perforations to allow for confluent air flow between adjacent intra-cell compartments within a cell, the first inflatable cell becoming circumferentially constricted when the intra-cell compartments of the first inflatable cell are inflated, the second inflatable cell becoming circumferentially constricted when the intra-cell compartments of the second inflatable cell are inflated, the first and second inflatable cells being non-confluent such that the first and second inflatable cells are separately inflatable, the intra-cell compartments, while being inflated, substantially simultaneously expanding in a direction substantially normal to a surface of the limb and contracting in a direction substantially coaxially to the surface of the limb; means for laterally coupling outermost compartments so as to form a sleeve; and a portable hand-held compression system console including a control unit for determining the sequence of cell inflation and deflation.
A further aspect of the present invention is a method for immobilizing a fractured bone in a limb. The method couples outermost intra-cell compartments of a first inflatable cell having a plurality of intra-cell compartments and outermost intra-cell compartments of a second inflatable cell having a plurality of intra-cell compartments, the coupling of the outermost intra-cell compartments of first and second inflatable cells forming a sleeve around a limb, the sleeve comprising, each including at least three intra-cell compartments, the intra-cell compartments being confluent and elongated along a longitudinal axis and being substantially rectangular in shape when deflated and being substantially cylindrical in shape when inflated, the longitudinal axes of the compartments substantially aligning with the primary axis of the limb, wherein the inflatable cells each comprise inner and outer shells of durable flexible material, the inner and outer shells being bonded together about a perimetric cell bond to define the inflatable cell therebetween, the inner and outer shells being further bonded together along compartmental bonds within the perimetric cell bond to define the plurality of intra-cell compartments, wherein the perimetric cell bond includes upper and lower perimetric cell bonds extending substantially in a lateral direction, and left and right perimetric cell bonds extending substantially in the longitudinal direction, and wherein the compartmental bonds partly extend between the upper and lower perimetric cell bonds, wherein the compartmental bonds include perforations to allow for confluent air flow between compartments within a cell, compartments within a cell being spatially fixed relative to each other such that upon inflation of a cell; and inflates one of the inflatable cells to apply pressure to the limb by circumferentially constricting the inflated cell, the intra-cell compartments of the inflated cell, while being inflated, substantially simultaneously expanding in a direction substantially normal to a surface of the limb and contracting in a direction substantially coaxially to the surface of the limb.
Another aspect of the present invention is a device for applying pressure to a body limb having a primary axis. The device includes first and second inflatable cells, the first and second inflatable cells each including at least three intra-cell compartments, the intra-cell compartments being confluent, the intra-cell compartments being elongated along a longitudinal axis and being substantially rectangular in shape when deflated and substantially cylindrical in shape when inflated, the first and second inflatable cells being adjacent each other and arranged coaxially with respect to the primary axis of the limb, the first and second inflatable cells each including inner and outer shells of durable flexible material, the first and second inflatable cells each including inner and outer shells of durable flexible material, the inner and outer shells being bonded together to form a perimetric bond about a perimeter of the inflatable cell, the perimetric bond defining the inflatable cell as a volume between the inner and outer shells and within the perimetric bond, the inner and outer shells being further bonded together to form a plurality of compartmental bonds within the inflatable cell bond, the plurality of compartmental bonds defining at least three intra-cell compartments, the perimetric cell bond including first and second perimetric cell bond portions, the first and second perimetric cell bond portions being substantially parallel thereto, wherein a portion of the compartmental bonds partly extending between the first and second perimetric cell bond portions, the compartmental bonds extending between the first and second perimetric cell bond portions including perforations to allow for confluent air flow between adjacent intra-cell compartments within a cell, the first inflatable cell becoming circumferentially constricted when the intra-cell compartments of the first inflatable cell are inflated, the second inflatable cell becoming circumferentially constricted when the intra-cell compartments of the second inflatable cell are inflated, the first and second inflatable cells being non-confluent such that the first and second inflatable cells are separately inflatable, the intra-cell compartments, while being inflated, substantially simultaneously expanding in a direction substantially normal to a surface of the limb and contracting in a direction substantially coaxially to the surface of the limb; means for laterally coupling outermost compartments so as to form a sleeve; and a compression system console including control means for determining a temporo-spatial regime of cell inflation.
A further aspect of the present invention is an automatic portable ambulant system for applying pressure to a body limb. The system includes a sleeve including first and second inflatable cells, the first and second inflatable cells each including at least three intra-cell compartments, the intra-cell compartments being confluent, the intra-cell compartments being elongated along a longitudinal axis and being substantially rectangular in shape when deflated and substantially cylindrical in shape when inflated, the first and second inflatable cells being adjacent each other and arranged coaxially with respect to the primary axis of the limb, the first and second inflatable cells each including inner and outer shells of durable flexible material, the inner and outer shells being bonded together to form a perimetric bond about a perimeter of the inflatable cell, the perimetric bond defining the inflatable cell as a volume between the inner and outer shells and within the perimetric bond, the inner and outer shells being further bonded together to form a plurality of compartmental bonds within the inflatable cell bond, the plurality of compartmental bonds defining at least three intra-cell compartments, the perimetric cell bond including first and second perimetric cell bond portions, the first and second perimetric cell bond portions being substantially parallel thereto, wherein a portion of the compartmental bonds partly extending between the first and second perimetric cell bond portions, the compartmental bonds extending between the first and second perimetric cell bond portions including perforations to allow for confluent air flow between adjacent intra-cell compartments within a cell, the first inflatable cell becoming circumferentially constricted when the intra-cell compartments of the first inflatable cell are inflated, the second inflatable cell becoming circumferentially constricted when the intra-cell compartments of the second inflatable cell are inflated, the first and second inflatable cells being non-confluent such that the first and second inflatable cells are separately inflatable, the intra-cell compartments, while being inflated, substantially simultaneously expanding in a direction substantially normal to a surface of the limb and contracting in a direction substantially coaxially to the surface of the limb; means for laterally coupling the outermost intra-cell compartments within a cell so as to form a sleeve; and a portable hand-held compression system console including a control unit for determining the sequence of cell inflation and deflation.
A still further aspect of the present invention is a device for applying pressure to a body limb having a primary axis. The device includes an inflatable cell; the inflatable cell including at least two intra-cell compartments, the intra-cell compartments being confluent, each intra-cell compartment being elongated in a direction of the primary axis, the inflatable cell further including inner and outer shells of durable flexible material, the inner and outer shells being bonded together about a perimetric cell bond, the inner and outer shells being further bonded together along compartmental bonds within the perimetric cell bond to define each intra-cell compartment, the perimetric cell bond including upper and lower perimetric cell bonds, the compartmental bonds partly extending between the upper and lower perimetric cell bonds, the compartmental bonds including perforations to allow for confluent air flow between adjacent intra-cell compartments within the cell, adjacent intra-cell compartments being spatially fixed relative to each other, such that upon inflation, the cell becomes circumferentially constricted. The intra-cell compartments, while being inflated, substantially simultaneously expand in a direction substantially normal to a surface of the limb and contract in a direction substantially coaxially to the surface of the limb.
Another aspect of the present invention is a device for applying pressure to a body limb having a primary axis. The device includes an inflatable cell, the inflatable cell including at least two intra-cell compartments, the intra-cell compartments being confluent to allow for confluent air flow between adjacent intra-cell compartments within the cell, adjacent intra-cell compartments being spatially fixed relative to each other, such that upon inflation, the cell becomes circumferentially constricted. The intra-cell compartments, while being inflated, substantially simultaneously expand in a direction substantially normal to a surface of the limb and contract in a direction substantially coaxially to the surface of the limb.
A further aspect of the present invention is an automatic portable ambulant system for applying pressure to a body limb. The system includes an inflatable cell, the inflatable cell including at least two intra-cell compartments, the intra-cell compartments being confluent, each compartment being elongated in a direction of the primary axis, the inflatable cell further including inner and outer shells of durable flexible material, the inner and outer shells being bonded together about a perimetric cell bond, the inner and outer shells being further bonded together along compartmental bonds within the perimetric cell bond to define each intra-cell compartment, the perimetric cell bond including upper and lower perimetric cell bonds, the compartmental bonds partly extending between the upper and lower perimetric cell bonds, the compartmental bonds including perforations to allow for confluent air flow between adjacent intra-cell compartments within the cell, adjacent intra-cell compartments being spatially fixed relative to each other, such that upon inflation, the cell becomes circumferentially constricted, the intra-cell compartments, while being inflated, substantially simultaneously expanding in a direction substantially normal to a surface of the limb and contracting in a direction substantially coaxially to the surface of the limb; and a portable hand-held compression system console including a control unit for determining a sequence of cell inflation and deflation.
The present invention may take form in various components and arrangements of components, and in various steps and arrangements of steps. The drawings are only for purposes of illustrating a preferred embodiment and are not to be construed as limiting the present invention, wherein:
The present invention will be described in connection with preferred embodiments; however, it will be understood that there is no intent to limit the present invention to the embodiments described herein. On the contrary, the intent is to cover all alternatives, modifications, and equivalents as may be included within the spirit and scope of the present invention as defined by the appended claims.
For a general understanding of the present invention, reference is made to the drawings. In the drawings, like reference have been used throughout to designate identical or equivalent elements. It is also noted that the various drawings illustrating the present invention are not drawn to scale and that certain regions have been purposely drawn disproportionately so that the features and concepts of the present invention could be properly illustrated.
In the following, an embodiment of the present invention will be described for use on the leg of an individual. However, it is to be understood that the present invention is also intended for use on any body limb such as an arm, a foot, a part of a leg, arm or foot, and may be used on two or more limbs simultaneously.
In
As can be seen in
In accordance with the present invention, the cells are subdivided into a plurality of longitudinally extending intra-cell compartments 7. The intra-cell compartments 7 are formed, for example, by welding the inner and outer shells of the massaging sleeve along the boundaries of the intra-cell compartments. The intra-cell compartments 7 in a given cell are confluent due to perforations 8 in the seams between adjacent intra-cell compartments 7 so that all the intra-cell compartments 7 in the cell are inflated or deflated essentially simultaneously. Each intra-cell compartment 7, when inflated, assumes essentially the shape of a cylinder having its axis parallel to that of the limb.
As can be seen in
In accordance with the present invention, the cells of
A theoretical cross-section of a deflated cell is shown in
Due to various factors that will be discussed below in more detail, the length of the inner circumference 9″ of the inflated cell, in actuality, will be something less than 2Nr so that the fractional decrease in the inner circumference upon inflation is thus is less than or about 0.36.
N and r are chosen so that Nr (the circumference of the deflated cell) corresponds to the original circumference of the limb segment contained within the lumen of the cell. The fractional decrease in the circumference of the cell upon inflation causes a contraction of the cell whereby pressure is applied to the limb that, as follows from the equation above, is independent of N and r.
Thus, by choosing N sufficiently large, and r correspondingly small, a sleeve is obtained having an inflated outer circumference not substantially larger than the original circumference of the limb. This is in contrast to conventional pressure sleeves, which must have a circumference greater than the initial circumference of the limb in order to achieve the same applied pressure as that produced by the present invention.
Letting now L be the height of a cell and C=Nr+w wherein w is the length attributed by the widths of the compartmental welds between the intra-cell compartments, the initial circumference of the limb contained within the cell, it is readily appreciated from
Inflating the cell thus leads to a decrease in the volume of the limb contained within the cell of less than or about equal to 60%. This decrease in volume represents the volume of fluid squeezed out of the limb or the work performed by the sleeve. This is accomplished by inflating the intra-cell compartments of the cell to a total volume of VT=Nr2L=N(C/N)2L=(C2L)/N.
In contrast to this, obtaining the same decrease in the volume of the limb by conventional compression methods requires inflating a cell to a final volume of VF={(1.36C/2)2−(0.64C/2)2}L=(C2L)/(2.8).
Thus, when the number of intra-cell compartments in the cell of the present invention is at least 3, the volume to which the cell must be inflated is less than that of conventional compression devices. Moreover, choosing N to be sufficiently large can obtain a decrease of 59% in the volume of the limb by inflating the cell to an arbitrarily small total volume. For example, when N=30, the total volume of the inflated cell is theoretically less than one-tenth of the volume of the inflated cell of the conventional compression devices. This allows a much smaller compressor to be used than is possible with conventional sleeves, thus permitting the patient to be ambulatory while being treated by the present invention.
The three intra-cell compartments 3020, 3030, and 3040 are formed from perimetric welds or bonds (not shown) and compartmental welds or bonds 3025 and 3035. Between adjacent intra-cell compartments 3020 and 3030 is compartmental weld 3025, and between adjacent intra-cell compartments 3030 and 3040 is compartmental weld 3035.
When the pressure sleeve is deflated, as shown by pressure sleeve 3000, and is decoupled, the pressure sleeve realizes a first circumference value C1 as measured between points X and Y. On the other hand, as illustrated in
It is noted that the shortening value S is affected by many parameters of the sleeve, such as: (1) the chemical and physical properties of the material used in constructing the sleeve (elasticity, flexibility, etc.; (2) the thickness of the material layer; (3) as noted above, the width of the welding lines or compartmental bonds; (4) the number of layers that are welded together; (5) the specific parameters of the welding procedure that is used and how it affects the chemical and physical characteristics of the material; and (6) the inflation pressure.
The integrated effect of all these parameters is very difficult to predict and thus to practically handle their integrated effect an empirical factor f is utilized to define the shortening value S, or in other words, the amount of circumferential constriction realized by the pressure sleeve for a given pressure. Using the empirical factor f, S is defined as f((−2)/)(C1−((N−1)B)) wherein C1 is the actual length of the cell, as illustrated in
The empirical factor f can be calculated for a pressure sleeve when it is inflated to a specific pressure.
For example,
It is noted that pressures within the “clinical” or operational range (75 mmHg to ˜250 mmHg) are the pressures of real interest, and thus, within this range, it can be seen that the pressure within a pressure sleeve has a nearly linear relationship with the empirical factor f, namely, f=a+bp where b is the slope of the line passing through the measured data points between ˜75 mmHg and ˜250 mmHg, a is the f-axis intercept, and p is the specific pressure within the pressure sleeve. More specifically, using the illustrated example of
Therefore, using the above-described methodology of measuring the shortening value S of the pressure sleeve at various pressures with the clinical or operational range, the empirical factor f of the specific pressure sleeve can be determined.
In using the relationships discussed above, a pressure sleeve according to the concepts of the present invention, which has an actual length (C1) of 385 mm, a single weld width (B) of 1.7 mm, an empirical factor f of 0.53 at 85 mmHg, and contains 15 adjacent intra-cell compartments (N), would have a shortening value of about 68 mm. Such a shortening value would result in an about 33% reduction in the volume of the limb surrounded by the sleeve.
As can be seen from the discussion above and from
Another reason for the improved reduction is the present invention's utilization of the intra-cell compartments. The intra-cell compartments, through the compartment bonds or welds (3025 and 3035), enables the present invention to realize a greater volume reduction with respect to the limb with less air than the conventional devices.
More specifically, as illustrated in
The simultaneous expansion in one dimension and contraction in a substantial normal direction of the intra-cell compartments provides a circumferential constriction of the pressure sleeve and thus reducing the volume of the underlying limb and causing blood to flow from the area. Moreover, due to the simultaneous expansion in one dimension and contraction in a substantial normal direction of the intra-cell compartments, the present invention can also utilize less area and realize the same volume reduction, thus increasing the life of the air compressor and reducing the energy consumption of the device.
It is noted that a sleeve according to the present invention, e.g. such as sleeve 1 in
A source of compressed air, such as a compressor 64, is powered by the batteries or the main electrical outlet, and connected to the sleeve or sleeves 52 by pneumatic conduits 54. A control unit 68 is adapted to receive inputs from the operator and from pressure sensors 62 and 63. The control unit serves to read and control the operation of the compressor 64 and to control the cyclic inflating and deflating of the sleeve 53 (in
Alternatively both hardware and software of the current invention enables the operation of the device from an external pressurized air and power sources. In some hospitals the source of pressurized air can be the central source of pressure-regulated supply that has wall outlets adjacent to the power outlets or that both the external power and pump sources could be an integral part of the patient's bed.
The use of miniaturized components like the compressor 64 and solenoid valves 66, together with the miniature accessories, results in small power consumption that enables the operation of the pneumatic device on batteries, while maintaining small dimensions and lightweight of the operating unit. The use of a sleeve 53 with a small-inflated volume will improve the obtained results of the operation unit for better clinical operation and results.
The operation of the system of the present invention will now be described. Pneumatic devices apply cyclic sequential pressure on a body's legs or arms. The cyclic sequential pressure is applied on the treated parts of the body by inflating and deflating each cell 53 of the sleeve 52 at a predefined timing. While being inflated, the multi-chambered segmented sleeve 52 should be encircling the part of leg to be treated. While the sleeve is inflated, a local pressure is applied at the contact area between the sleeve and the body.
The control unit 68, which can be software based, controls the operation of the compressor 64 and solenoid valves 66. The control unit can be programmed to achieve any desired inflating and deflating sequence and timing including delay intervals, in accordance with clinical application. For example, in the case of two three-chambered sleeves (six solenoid valves), the controller can be programmed to operate in accordance with the table of parameters for the control unit shown in
Each time interval from the table (T1, T2 . . . T7), as illustrated in
In
A WAIT procedure starts at step (805A) where keys are checked. If keys are not pressed, the system blinks the program flags at the display (807). If more than 1 minute has passed without any key pressed (808), the system enters error mode 1 ((809) and (841-845)). Restarting the system is the only way to go back from this mode of operation.
If a program key is pressed, the system de-bounces for 0.5 sec and then checks the keys again (810). If no key is pressed after the de-bounce time, the system returns to the start of the WAIT procedure. If a key is pressed after the de-bounce time, the system turns on the selected program flag (on the display) (812), and after a 0.25 sec delay (813) resets the WDT and starts the sequencer procedure (815).
With reference now to
The sequence starts by moving data to the pump and the valves and continues with a short period delay before checking the pressure sensors (820). Until this delay is finished, the system waits (820-821). After that, the system checks the sensors (823). If the sensors do not react correctly until the max available time (823, 824, 822), a sequence step error is stored (825). Later on, those errors will be analyzed (830-836). If the sensors reacted correctly at the time window, a non-error flag is stored (826). The system branches to the error analyzing procedure (827 and 830). If the system returns (not enough errors to hold), the cycle step counter advances (828, 829) and the next step starts (819).
In
If the number of errors does not exceed 2, the system initializes the WDT and returns to step (827) and continues. The termination procedure is as follows. The termination procedure starts at step (837) by operating the buzzer (838), and waits 10 seconds (839, 840) before re-operating the buzzer.
In
The WDT procedure starts at step (846), by resetting and reprogramming the WDT counter to a 1 second interval. If, within this time interval (847) no WDT initialization pulse arrives (848), the WDT will reset the whole system (850).
Battery check procedure (855-859) uses hardware mechanisms that operate independently, without the software. External supply check procedure (860 to 863) uses hardware mechanisms that operate independently, without the software.
With reference to
The procedure starts at step (864), then the system checks the presence of an intelligent sleeve (865). If one exists, the sequence is loaded from the intelligent sleeve (867). If no intelligent sleeve is detected, then the pre-loaded sequence is loaded (866). Finishing loading the system causes the program to return to the next step (817).
Additional miniaturization and mechanical simplification of the portable ambulant pneumatic pressure system of the present invention can be achieved by introducing self-operated relief valves replacing the controlled operated solenoid valves. Another embodiment of a portable pneumatic pressure system 90 of the present invention is illustrated in
An independent source of energy, for example rechargeable batteries, is provided which enables the pneumatic operation without a fixed connection to a main electrical power outlet, The batteries can be bypassed and thus system can operate for longer time periods while it is connected to the main power, and the batteries can be recharged at the same time.
A source of compressed air, such as a compressor 104, powered by the batteries or by the main power, is connected to the sleeve 92 or sleeves by one single pneumatic conduit 94, which enables inflating and deflating the cells 93. The compressor in this embodiment can enable the inverted flow to deflate the cells of the sleeve. It is possible to use a rotary compressor or to enable the inverted deflating flow by means of a valve, which may be solenoid operated and which is actuated by a control unit 108, or alternatively a pneumatic operated normally open valve can be used. The valve will be kept closed using the pressure of the compressor while the compressor is energized, and will open by itself when the compressor is stopped.
The control unit 108 is adapted to receive the operator's commands and control the operation of the compressor to control the cyclic inflating and deflating of the sleeve. Solenoid valves are replaced, in this embodiment, by self-operated relief valves 95, one with each chamber. The compressor is directly connected to the first cell. Each cell is connected to the next, one through a relief valve to regulate the pressure and maintain a pressure gradient. Each relief valve (except the last one) is bypassed with a conduit section including a check valve 96 to allow deflating of the cell. The last relief valve is open to the atmosphere, thus limiting the maximal pressure in the cells.
The control unit 108 controls the operation of the compressor 104 to inflate the first cell 93. The pressure in the first cell is built-up, and when it gets higher than the first relief valve 95 opening pressure, the second cell starts to be inflated. The third cell is inflated while the pressure in the second cell reaches the burst pressure of the second relief valve. The inflating process will continue in the same manner until the last cell is inflated. When the pressure in the last cell bursts the last relief valve, air will commence to flow out to the atmosphere preventing an uncontrolled pressure build-up inside the sleeve. When the operating interval of the compressor terminates, the controller de-energizes the compressor and enables all of the cells to be deflated simultaneously.
By using self-operated relief valves instead of the controlled solenoid valves, the system in accordance with the present invention will be smaller, lighter, have longer independent operation (as power consumption is reduced), and will be more cost effective. There will be a decrease in the operational flexibility because the relief valves are self-operated, and the controller is not able to control the inflating sequence of the cells.
The automatic portable ambulant pneumatic pressure system of the present invention is capable of treating more than one part of the body by connecting more than one sleeve to the pump unit. Sometimes, for medical reasons, the treatment is not symmetric on the body, i.e., treatment applied on the left calf and the right foot, and a different treatment is required in each sleeve. The sleeves used for the different treatments differ from each other by appearance because they are designed to operate on a different part of the body. They can also differ with the number of chambers and the connected conduits. The pump unit has the capability to operate each one of the sleeves with the appropriate medical treatment cycle.
The pump unit of the present invention can automatically identify the appropriate combination of treatments and/or pressures without requesting information from the operator. The operator selects the right sleeves and connects them to the pump unit. That will be sufficient for the system to identify the required treatment cycles and/or pressures and will prevent the possibility of mismatched input to the system by selecting a treatment and/or pressure, which is not suitable to the connected sleeves or vice versa.
To make a proper identification of the required treatment and or pressures, the present invention includes an identification system or process within the processor, which enables the present invention to correctly identify the combination of sleeves attached to it and automatically activates the appropriate operation algorithm. This capability is crucial if the device has to be kept as a user friendly “On/Off” device, in spite of its outstandingly high versatility depicted in its ability to operate foot/foot and calf/foot and thigh/calf/thigh sleeves and used on one or two legs with/with out pressure accumulator(s), and/or any proper combination thereof.
The identification system will now be briefly described. The present invention contains X solenoid operated valves, and each one of them is capable of connecting a pressure device, such as an air cell in a pressure sleeve or pressure accumulator, to a pressurized air source. The pressurized air source can be a central reservoir of pressurized air, internal or external air accumulator, or (usually) the air pump of the device itself. For each specific solenoid, two inflation time constants were determined: Tmax and Tmin.
A proper inflation time (Tn) of a pressure device has to be between Tmin and Tmax (Tmin<Tn<Tmax).
When Tn>Tmax in a normally functioning device, it means that either no pressure device was connected to the specific solenoid, that the pressure device that was connected is leaking, or the connected pressure device is not an authorized pressure device.
When Tn<Tmin in a normally functioning device, it means that the outflow tract of the specific solenoid is partially or completely blocked.
The above three described conditions are used by the present invention to correctly identify the pressure device or combination of pressure devices (wherein the pressure devices may be specialized pressure sleeves; such as foot pressure sleeves, calf pressure sleeves, thigh pressure sleeves or any combination thereof; pressure accumulators, or combinations thereof) attached to the present invention and automatically activates the appropriate operation algorithm
A more detailed description of this identification process will be provided below in connection with the description of
After the present invention is turned ON, the present invention first runs a “checking program” that tests the inflation time (Tn) of each one of the X available solenoids. The test is done under “standard” pressure and pump flow conditions, and the solenoids are tested in sequence (1×). For each solenoid, the inflation time Tn can be or Normal (“A”) or >Tmax (“B”) or <Tmin (“C”), as illustrated in
As illustrated in
The sequence of the results in all X solenoids creates a specific code that is representative of the state of the pressure device and/or the type of the pressure device connected to each solenoid. If this code is recognized by the microprocessor as a valid one (one that appears in its lookup table), the microprocessor will switch the device from the “checking program” into the specific operation process or algorithm. If the created code does not appear in the lookup table, the created code will be identified as invalid, and the microprocessor will deactivate the device. In a preferred embodiment, an audiovisual alarm will be activated. Examples of the possible code generation are illustrated in
In
In
In
In
In
It is noted that the code “A” can be further modified to be “A”, “A1”, “A2” . . . “An”, to provide a more specific identification of the sleeve of combination of sleeves attached to the pump device of the present invention. For example, code “A” could be associated with a foot sleeve wherein T1>Tn>Tmin. Moreover, code “A1” could be associated with a one cell of a calf sleeve wherein T2>Tn>T1. Lastly, code “An” could be associated with a pressure accumulator wherein Tmax>Tn>Tn-1. By providing more flexibility with the generation of code “A”, the present invention could be enable to operate with an air conduit connector 1111 that has three air conduits or flow tracts 1112, which are connected to a double cell calf sleeve 1150 and a pressure accumulator 1110, as illustrated in
This “identification system” is very simple to apply and no special hardware changes are necessary. It enables the device to remain an “On-Off” device in spite of its high versatility. It prevents the use of defective sleeves, undesired sleeve combinations, or unauthorized sleeves.
Alternatively the control unit, within the pump unit, can read the input information about the required treatment by reading the coding of the sleeves connectors. While starting any new treatment cycle, the control unit will start the treatment by a quick identification of the type of sleeves connected and will apply the appropriate operating cycle. The coding of the sleeve connectors can be made by state of the art mechanical or electro-mechanical components wherein each air conduit connector has a mechanical tag, an electronic tag, an optical tag, or an electromechanical tag, all which could be read by the pump unit. This would replace the pressure generation measurement identification process. It is also possible to store the required treatment parameters on the sleeve's connector as part of the mechanical tag, an electronic tag, an optical tag, or an electromechanical tag according to the sleeve's projected treatment. On start-up of the system, the data will be transferred to the pump unit through either mechanical, electrical, optical means, or a combination thereof, and the treatment cycle will be compatible to the selected sleeve. Moreover, it contemplated that the therapist will be able to program the sleeve's parameters through manipulation of the mechanical tag, the electronic tag, the optical tag, the electromechanical tag, or combination thereof to fit the treatment to the specific patient.
Another feature is that a pressure sensors array 1104 measures the pressure at the end of each pressure line 1106. The data collected at this stage is transmitted, via the processor unit 1102, to the processor in the pump unit, in order to evaluate the status of the system. The sleeve 1105 has several cells that can be independently inflated by the pump unit. The number of cells in the sleeve can vary, according to desired treatments.
In
The cells 115a, 115b, and 115c are formed from a flexible, fluid imperious material such as cloth-lined rubber or canvas. The pressure sleeve 105 may be formed for example from an inner cylindrical shell 150 and an outer cylindrical shell 155 formed from a flexible fluid impervious material. Seams 160 at the boundaries of cells 115a, 115b, and 115c are formed by welding the inner cylindrical shell 150 and outer cylindrical shell 155 together at the seams.
The flow of a pressurized fluid through conduits 120a, 120b, and 120c into the associated cell 115a, 115b, and 115c, respectively, inflates the cell so as to exert a pressure on a limb contained in a lumen 125 of the pressure sleeve 105, as explained above. One or more of the cells 115a, 115b, and 115c may optionally be divided into two or more intra-cell compartments 130, as shown, for example, for the cell 115c. The intra-cell compartments 130 are formed by seams 135 extending in a longitudinal direction of the pressure sleeve 105. The seams 135 are incomplete at perforations 136 so that the intra-cell compartments 130 are inflated essentially simultaneously when pressurized fluid enters the cell 115c. As explained above, this decreases the volume of the cell 115c so that a predetermined pressure on a limb positioned in the lumen 125 of the pressure sleeve 105 is realized.
The pressure accumulator 110 comprises a container 140 formed from a fluid impervious material. The container 140 may be made from a flexible material such as cloth-lined rubber or canvas. Alternatively, the container 140 may be made from a rigid material such as plastic or metal. The accumulator 110 further comprises a tubular conduit 145 that serves both as an inlet for pressurized fluid into the container 140 as well as an outlet for fluid out of the container 140.
The pressure accumulator 110 enables the compression system to provide intermittent pneumatic compression, fast intermittent pneumatic compression, fast inflation, less complexity, lower costs, and greater patient comfort. Moreover, the pressure accumulator 110 enables the compression system to provide effective therapeutic venous flow acceleration.
It is noted, according to the concepts of the present invention, that the pressure accumulator 110, as illustrated in the embodiment of
This is by way of example only, and the pressure sleeve 205 may comprise any number of cells. As with the sleeve shown in
The pressure accumulator 210 comprises a container 240 formed from a fluid impervious material. The accumulator 210 further comprises a tubular conduit 245 that serves both as an inlet for pressurized fluid into the container 240 as well as an outlet for fluid out of the container 240. The outside part of the container 240 may be made from a flexible material such as cloth-lined rubber or canvas; however, the inside part of the container 240 should be made from a rigid material, such as a hard plastic or metal, to prevent any pressure from the pressure accumulator from being incorrectly transmitted to the patient. Alternatively, the entire container 240 may be made from a rigid material, such as a hard plastic or metal. The container 240 may partially surround the lumen 225 of the pressure sleeve 205 as shown in
In a preferred embodiment, the pressure sleeve 205 is formed from an inner cylindrical shell 250 and an outer cylindrical shell 255 formed from a flexible fluid impervious material. Seams (260a, 260b, 260c, 260d, and 260e) at the boundaries of the cells, at the boundaries of the container 240 or at the boundary between the container 240 and the cell 215a are formed by welding the inner and outer sleeves together at the seams.
This is by way of example only, and the pressure sleeve 1150 may comprise any number of cells. As with the sleeve shown in
The pressure accumulator 1110 comprises a container 240 formed from a fluid impervious material. The accumulator 210 further comprises a tubular conduit 245 that serves both as an inlet for pressurized fluid into the container 240 as well as an outlet for fluid out of the container 240. The container 240 may be made from a flexible material such as cloth-lined rubber or canvas. Alternatively, the container 240 may be made from a rigid material such as plastic or metal.
In a preferred embodiment, the pressure sleeve 1150 is formed from an inner cylindrical shell 250 and an outer cylindrical shell 255 formed from a flexible fluid impervious material. Seams (260a, 260b, 260c, and 260d) at the boundaries of the cells are formed by welding the inner and outer sleeves together at the seams.
As noted above, the pressure sleeve-pressure accumulator combination 1120 is connected via tubular conduit (220a, 220b, and 245) to air conduit connector 1111 that has three air conduits or flow tracts 1112.
The combination 300 further comprises a pressure accumulator 310. The pressure accumulator 310 has been incorporated into the sole of the slipper 307. The pressure accumulator 310 comprises a container 340 formed from a fluid impervious material that is sufficiently flexible so as to allow it to bend for comfortable walking while being sufficiently rigid so that it does not collapse under the weight of the user. The container 340 may be formed, for example, from reinforced rubber. The pressure accumulator 310 further comprises a tubular conduit 345 that serves both as an inlet for pressurized fluid into the container 340 as well as an outlet for fluid out of the container 340.
The combination 300 lastly comprises a foot fastener 303 that causes the pressure sleeve 305 to be snug around the foot 301. This foot fastener 303 may be a Velcro™ strap or other device that enables the pressure sleeve 305 to be formed around the foot 301. An ankle strap 304 is provided to prevent the pressure sleeve 305 and slipper 307 from shifting or coming disengaged from the foot 301. The ankle strap 306 may be a Velcro™ strap or other device that prevents the pressure sleeve 305 and slipper 307 from shifting or coming disengaged from the foot 301. The ankle strap 304 is provided with a heel support 306 that prevents the foot from sliding out of the back of the slipper 304. The heel support 306 may be of a rigid material, such as a plastic, or a flexible material, such as cloth.
The pressure sleeve-pressure accumulator combination further comprises a pressure accumulator 410. The pressure accumulator 410 is separate from the pressure sleeve 2000. The pressure accumulator 410 comprises a container formed from a fluid impervious material. The container may be formed, for example, from a flexible material such as cloth-lined rubber or canvas or from a rigid material such as plastic or metal. The pressure accumulator 410 further comprises a tubular conduit 2015 that serves both as an inlet for pressurized fluid into the container as well as an outlet for fluid out of the container.
The combination lastly comprises foot fasteners 2009 that cause the pressure sleeve 2000 to be snug around the foot 301. The foot fasteners 2009 may be Velcro™ straps or other devices that enable the pressure sleeve 2000 to be formed around the foot 301. An ankle strap 2007 is provided to prevent the pressure sleeve 2000 from shifting or coming disengaged from the foot 301. The ankle strap 2007 may be a Velcro™ strap or other device that prevents the pressure sleeve 2000 from shifting or coming disengaged from the foot 301.
A more detail illustration of the pressure sleeve of
The foot pressure sleeve 2000 comprises foot fasteners 2009 and 2010 that causes the pressure sleeve 2000 to be snug around the foot. The foot fasteners 2009 and 2010 may be Velcro™ straps or other devices that enable the pressure sleeve 2000 to be formed around the foot. An ankle strap 2007 is provided to prevent the pressure sleeve 2000 from shifting or coming disengaged from the foot. The ankle strap 2007 may be a Velcro™ strap or other device that prevents the pressure sleeve 2000 from shifting or coming disengaged from the foot.
The pressure device further comprises a pressure accumulator 4200 that is located in a pressure accumulator flexible housing 4100. The pressure accumulator 4200 is separate from the foot pressure sleeve 4300. The pressure accumulator 4200 comprises a container formed from a fluid impervious material. The container may be formed, for example, from a flexible material such as cloth-lined rubber or canvas or from a rigid material such as plastic or metal. The pressure accumulator 4200 further comprises a tubular conduit 4020 that serves both as an inlet for pressurized fluid into the container as well as an outlet for fluid out of the container.
Lastly, as illustrated in
The pressure sleeve-pressure accumulator combination further comprises a pressure accumulator 410. The pressure accumulator 410 is separate from the pressure sleeve 2000. The pressure accumulator 410 comprises a container formed from a fluid impervious material. The container may be formed, for example, from a flexible material such as cloth-lined rubber or canvas or from a rigid material such as plastic or metal. The pressure accumulator 410 further comprises a tubular conduit 2015 that serves both as an inlet for pressurized fluid into the container as well as an outlet for fluid out of the container.
The combination lastly comprises a foot fastener 2009 that causes the pressure sleeve 2000 to be snug around the foot 301. The foot fastener 2009 may be a Velcro™ strap or another device that enables the pressure sleeve 2000 to be formed around the foot 301. An ankle strap comprising an ankle portion 304 and a heel portion 306 is provided to prevent the pressure sleeve 2000 from shifting or coming disengaged from the foot 301. The ankle strap comprising ankle portion 304 and heel portion 306 may include a Velcro™ strap or other device that prevents the pressure sleeve 2000 from shifting or coming disengaged from the foot 301.
A more detail illustration of the pressure sleeve of
The foot pressure sleeve 2000 comprises foot fasteners 2009 and 2010 that causes the pressure sleeve 2000 to be snug around the foot. The foot fasteners 2009 and 2010 may be Velcro™ straps or other devices that enable the pressure sleeve 2000 to be formed around the foot. An ankle strap 2008 comprising an ankle portion 304 and a heel portion 306 is provided to prevent the pressure sleeve 2000 from shifting or coming disengaged from the foot. The ankle strap 2008 comprising an ankle portion 304 and a heel portion 306 may include a Velcro™ strap or other device that prevents the pressure sleeve 2000 from shifting or coming disengaged from the foot.
The foot pressure sleeve 2000 has a forward section 2012 that can extend from an arch portion of a patient's foot to under either the ball of a patient's foot or the toes of a patient's foot. The forward section 2012, as illustrated in
The foot pressure sleeve 2000 also has a rearward section 2011 that substantially extends under the heel of a patient's foot. The cell has an associated tubular conduit 2014.
The foot pressure sleeve 2000 comprises foot fasteners 2009 and 2010 that causes the pressure sleeve 2000 to be snug around the foot. The foot fasteners 2009 and 2010 may be Velcro™ straps or other devices that enable the pressure sleeve 2000 to be formed around the foot. An ankle strap 2007 is provided to prevent the pressure sleeve 2000 from shifting or coming disengaged from the foot. The ankle strap 2007 may be a Velcro™ strap or other device that prevents the pressure sleeve 2000 from shifting or coming disengaged from the foot.
The foot pressure sleeve 2000 has a forward section 2012 that can extend from an arch portion of a patient's foot to under the ball of a patient's foot. The forward section 2012, as illustrated in
The foot pressure sleeve 2000 also has a rearward section 2011 that substantially extends under the heel of a patient's foot. The cell has an associated tubular conduit 2014 connected through port 2013.
The foot pressure sleeve 2000 comprises foot fasteners 2009 and 2010 that causes the pressure sleeve 2000 to be snug around the foot. The foot fasteners 2009 and 2010 may be Velcro™ straps or other devices that enable the pressure sleeve 2000 to be formed around the foot. An ankle strap 2008 comprising an ankle portion 304 and a heel portion 306 is provided to prevent the pressure sleeve 2000 from shifting or coming disengaged from the foot. The ankle strap 2008 comprising an ankle portion 304 and a heel portion 306 may include a Velcro™ strap or other device that prevents the pressure sleeve 2000 from shifting or coming disengaged from the foot.
The pressure sleeve used in conjunction with the console 515 preferably contains one or more cells divided into longitudinally extending compartments that are inflated and deflated essentially simultaneously. The console 515 is preferably portable and battery operated and includes an air compressor 502.
It is noted that air compressor 502 may be bypassed with pressurized air from an external source. The pressurized air would be introduced into the console 515 through pressurized air inlet 501.
The console 515 is also preferably configured to be carried on a user's body. For example, the console 515 may have clips (not shown) that allow the console 515 to be attached to the user's belt.
The console system shown in
The flow of air in the conduit 507 from the pressure accumulator towards the compressor 502 is prevented by the one-way valve 525. The pressure in the cell will rise rapidly to a pressure PC. PA and PC satisfy the relationship PAVA=PC(VA+VC) where VA is the volume of the container of the pressure accumulator and VC is the volume of the cell when inflated. Next, another cell, such as cell 115b of
The console system shown in
It is noted that air compressor 502 may be bypassed with pressurized air from an external source. The pressurized air would be introduced into the console 515 through pressurized air inlet 501.
In this application, the valve 505b is opened (in
In summary, the present invention is directed to a compression system for applying therapeutic pressure to a limb of a body that includes a pressure sleeve; a compression system console, pneumatically connected to the pressure sleeve, having a controller and compressor to provide controlled pressurized fluid to the pressure sleeve; and a pressure accumulator, flexibly tethered and pneumatically connected to the compression system console, to provide controlled pneumatic compression.
The pressure sleeve may include an inflatable cell. The inflatable cell may include at least two intra-cell compartments, the intra-cell compartments being confluent and each compartment being elongated in a direction of the primary axis. The inflatable cell may further include inner and outer shells of durable flexible material, the inner and outer shells being bonded together about a perimetric cell bond ands being further bonded together along compartmental bonds within the perimetric cell bond to define each intra-cell compartment. The perimetric cell bond includes upper and lower perimetric cell bonds. The compartmental bonds partly extend between the upper and lower perimetric cell bonds and include perforations to allow for confluent airflow between adjacent intra-cell compartments within the cell. Adjacent intra-cell compartments are spatially fixed relative to each other, such that upon inflation of the cell, the cell becomes circumferentially constricted.
The bonds include welds. The adjacent intra-cell compartments are contiguous, and the perforations are located adjacent the perimetric cell bond. The perforations are also located between compartmental bonds extending from the upper and lower perimetric bonds.
The pressure accumulator includes a fastener device to fasten the pressure accumulator to a user of the compression system. The compression console system is portable, battery operated with a rechargeable battery. The compression system indicates an appropriate inflation and deflation sequence.
The pressure sleeve of the present invention may include an integral pressure accumulator and an inflatable cell operatively pneumatically connected to the integral pressure accumulator. The pressure sleeve of the present invention may also be a therapeutic foot device that includes a pressure sleeve; a sole member; and a pressure accumulator provided in the sole member and operatively pneumatically connected to the pressure sleeve.
As described above, the present invention also contemplates a therapeutic pressure system that includes a pressure sleeve and a compression system console, pneumatically connected to the pressure sleeve, having a controller and compressor to provide controlled pressurized fluid to the pressure sleeve. The controller, upon entering a first mode, identifies a type of the pressure sleeve connected to the compression system console. The therapeutic pressure system further includes a plurality of solenoids to convey pressurized air from the compressor to air conduits. The controller causes individual solenoids to activate so that the compressor supplies pressurized air through the activated solenoid to determine if a proper pressure device is connected thereto through an associated air conduit.
Although the various embodiments of the pressure sleeves of the present invention have been described in conjunction with a portable compression system console or small compression system console wherein the source of the pressurized air was within the console, the pressure sleeves of the present invention can be used with any compression system wherein the source of pressurized air may be without the console.
For example, it is contemplated by the present invention that the source of the air pressure for inflation of the pressure sleeves can be located in the patient's bed or be built into the wall of a room. This source of pressurized air can be directly connected to the pressure sleeves via proper air conduits (assuming that a pressure control device that regulates or control the delivery of pressurized air to the pressure sleeves is associated with the pressurized air source) or can be connected to the pressure sleeves of the present invention through a control device or system that regulates or control the delivery of pressurized air to the pressure sleeves of the present invention.
In other words, the present invention contemplates a system where the source of pressurized air is integral with the pressure control device or a system where the source of pressurized air is not integral with the pressure control device.
While various examples and embodiments of the present invention have been shown and described, it will be appreciated by those skilled in the art that the spirit and scope of the present invention are not limited to the specific description and drawings herein, but extend to various modifications and changes all as set forth in the following claims.
This application is a continuation-in-part of U.S. patent application Ser. No. 09/941,909, filed on Aug. 29, 2001 now U.S. Pat. No. 7,063,676; which is a continuation application of U.S. patent application Ser. No. 09/413,968, filed Oct. 7, 1999 now U.S. Pat. No. 6,494,852; which is a continuation-in-part of U.S. patent application Ser. No. 09/038,157, filed on Mar. 11, 1998 now U.S. Pat. No. 6,478,757 and a continuation-in-part of U.S. patent application Ser. No. 09/375,083, filed on Aug. 16, 1999 now U.S. Pat. No. 6,447,467. The entire contents of U.S. patent application Ser. Nos. 09/941,909; 09/413,968; 09/038,157; and 09/375,083 are hereby incorporated by reference. This application claims priority under 35 U.S.C. §119 to U.S. Provisional Patent Application Ser. No. 60/424,288, which was filed on Nov. 6, 2002. The entire contents of U.S. Provisional Patent Application Ser. No. 60/424,288 are hereby incorporated by reference.
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| Number | Date | Country | |
|---|---|---|---|
| 60424288 | Nov 2002 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 09413968 | Oct 1999 | US |
| Child | 09941909 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 09941909 | Aug 2001 | US |
| Child | 10370283 | US | |
| Parent | 09375083 | Aug 1999 | US |
| Child | 09413968 | US | |
| Parent | 09038157 | Mar 1998 | US |
| Child | 09375083 | US |
