Portable system for the prophylaxis of deep vein thrombosis

Abstract

A kit is disclosed for facilitating the supply and return of a system for stimulating venous and arterial circulation in a patient to prevent deep vein thrombosis, which includes a left and right set of inflatable garment sleeves that are disposable, a pair a rechargeable battery powered pump assemblies for inflating the sleeves and that are reusable, a power supply adapter for recharging the pump assemblies and that is reusable, and a shipping carton for returning the pump assemblies and adapter to a supplier after the patient is ambulatory and the risks of deep vein thrombosis have ended.

Claims

1. A system for stimulating venous and arterial circulation in a patient to prevent deep vein thrombosis, comprising: a) a first disposable garment sleeve configured to be wrapped around a left calf of the patient and having a compartmented air chamber formed in an interior surface thereof; b) a second disposable garment sleeve configured to be wrapped around a right calf of the patient and having a compartmented air chamber formed in an interior surface thereof; c) a first reusable pump assembly for pressurizing the air chamber in the first garment sleeve, wherein the first pump assembly includes a housing adapted to be detachably secured to an exterior surface of the first garment sleeve; d) a second reusable pump assembly for pressurizing the air chamber in the second garment sleeve, wherein the second pump assembly includes a housing adapted to be detachably secured to an exterior surface of the second garment sleeve; e) a dual cord power supply adapter for recharging a first rechargeable battery in the first pump assembly and a second rechargeable battery in the second pump assembly at the same time; f) a tray having recesses for packaging the first and second pump assemblies and the dual cord power supply adapter together; g) a shipping carton for enclosing the tray containing the first and second pump assemblies and the power supply adapter together and for returning the first and second pump assemblies and the power supply adapter to a supplier after the patient is ambulatory; and h) a supply carton for initially delivering the first and second garment sleeves and the shipping carton enclosing the tray containing the first and second pump assemblies and the power supply adapter to the patient, wherein each of the pump assemblies includes an electronic compliance meter associated with a processor that stores and reports information on demand regarding a length of time each one of the pump assemblies was in use to allow the supplier to monitor and control an inventory of used pump assemblies that have been returned, wherein the compliance meter in each one of the pump assemblies generates an audible reporting code that includes successive series of sounds, wherein each of the successive series of sounds represents a corresponding ordinal place holder, which taken together indicates a number of hours that each one of the pump assemblies was used, so that a first one of the series of sounds represents a first numeral and a second one of the series of sounds represents a second numeral.

2. A system as recited in claim 1, wherein the interior surface of each garment sleeve is fabricated from a non-woven polyester material.

3. A system as recited in claim 1, wherein the exterior surface of each one of the garment sleeves is fabricated from a nylex fabric.

4. A system as recited in claim 1, wherein each one of the pump assemblies has an alarm feature to indicate a low battery power condition.

5. A system as recited in claim 4, wherein each one of the pump assemblies has a means to shut down the system at a critically low battery power to avoid battery damage.

6. A system as recited in claim 1, wherein the processor in each one of the pump assemblies is programmed to command each one of the pump assemblies to inflate the air chamber in a respective garment sleeve to a preset pressure and the air chamber will deflate after a predetermined period of time.

7. A system as recited in claim 6, wherein the processor in each one of the pump assemblies is programmed to command each one of the pump assemblies to inflate the air chamber in a respective garment sleeve to a preset pressure of 50 mm Hg+/−10 mm Hg and hold that pressure for 15 seconds, whereupon the solenoid valve will open to allow the air chamber to deflate and be without pressure for 45 seconds.

8. A system as recited in claim 6, wherein each one of the pump assemblies has an alarm feature to indicate a low inflation pressure condition.

9. A system as recited in claim 6, wherein each one of the pump assemblies has an alarm feature to indicate a high inflation pressure condition.

10. A system for stimulating venous and arterial circulation in a patient to prevent deep vein thrombosis, comprising: a) a first garment sleeve configured to be wrapped around a left calf of the patient and having an air chamber formed in an interior surface thereof; b) a second garment sleeve configured to be wrapped around a right calf of the patient and having an air chamber formed in an interior surface thereof; c) a first pump assembly for pressurizing the air chamber in the first garment sleeve; and d) a second pump assembly for pressurizing the air chamber in the second garment sleeve, wherein each pump assembly includes an electronic compliance meter associated with a processor that stores and reports information on demand regarding a length of time each one of the pump assemblies was in use, wherein the compliance meter in each one of the pump assemblies generates an audible reporting code that includes successive series of sounds, wherein each of the successive series of sounds represents a corresponding ordinal place holder, which taken together indicates a number of hours each one of the pump assemblies was used, wherein a first series of sounds represents a first numeral in the number of hours the pump assembly was used and a second series of sounds represents a second numeral in the number of hours the pump assembly was used.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) So that those having ordinary skill in the art will readily understand how to make and use the system and kit of the subject invention without undue experimentation, preferred embodiments thereof will be described in detail herein below with reference to the figures wherein:

(2) FIG. 1 is an illustration of the portable system of the subject invention deployed for use on the legs of a patient, which includes right and left fragment sleeves, each having a portable pump attached thereto;

(3) FIG. 2 is a top plan view of the interior surface of the left garment sleeve shown in FIG. 1, in a flat unwrapped condition;

(4) FIG. 2A is an enlarged cross-sectional elevational view of the air input tube of the left garment sleeve taken along line 2A-2A of FIG. 2;

(5) FIG. 3 is a bottom plan view of a portion of the exterior surface of the left garment sleeve shown in FIG. 2, with a portable pump assembly attached thereto;

(6) FIG. 4 is a top plan view of the interior surface of the right garment sleeve shown in FIG. 1, in a flat unwrapped condition;

(7) FIG. 5 is a bottom plan view of a portion of the exterior surface of the right garment sleeve shown in FIG. 4, with a portable pump assembly shown attached thereto;

(8) FIG. 6 is an exploded perspective view of one of the portable pump assemblies of the subject invention with its parts separated for ease of illustration;

(9) FIG. 7 is an illustration of the kit of the subject invention, which includes a supply carton for initial delivery to a patient, which encloses a set of garment sleeves, and a shipping carton enclosing a tray containing two rechargeable pump assemblies and a power supply adapter;

(10) FIG. 8 is an illustration of the returnable components of the kit of the subject invention, which includes the shipping carton and the tray containing the two rechargeable pump assemblies and the power supply adapter;

(11) FIG. 9 is an illustration of two rechargeable pump assemblies connected to the dual corded power supply adapter which is plugged into an electrical outlet;

(12) FIG. 10 is an illustration of a patient with a set of left and right inflatable garment sleeves wrapped around their calves, and depicting the patient connecting the valve stem of a portable pump assembly to the air inlet tube of the right garment sleeve; and

(13) FIG. 11 is a localized illustration relating back to FIG. 1, showing the patient activating the portable pump assembly that is detachably secured to the exterior surface of the right inflatable garment sleeve.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(14) Referring now to the drawings wherein like reference numerals identify similar structural features or elements of the subject invention, there is illustrated in FIG. 1 a new and useful system designated generally by reference numeral 100 for stimulating venous and arterial circulation in a patient to prevent deep vein thrombosis (DVT) and a kit for facilitating the supply and return of the system to a supplier after the patient is ambulatory and the risks of deep vein thrombosis have ended. The system is intended for non-ambulatory patients both in the hospital setting and at home.

(15) Referring now to FIG. 1, the system 100 includes a first garment sleeve 10 that is adapted and configured to be wrapped around the left calf of the patient, and a second garment sleeve 20 that is adapted and configured to be wrapped around the right calf of a patient. A portable electromechanical pump assembly 30 is detachably secured to the first garment sleeve 10 and a second portable electromechanical pump assembly 40 is detachably secured to the second garment sleeve 20.

(16) Referring to FIGS. 2 and 3, the first garment sleeve 10 has a compartmented air chamber 12 embossed or otherwise formed in an interior surface 14 thereof. Air chamber 12 communicates with an air input tube 16 that is located on an exterior surface 18 of the garment sleeve 10 (see FIG. 2A). Garment sleeve 10 further includes an interior surface portion 23 that has three spaced apart fingers 25a-25c, each of which includes a respective hook type fastener pad 27a-27c for detachably engaging the exterior surface 18 of the garment sleeve 10 when it is wrapped around the left calf of the patient, as illustrated in FIG. 1.

(17) The first portable pump assembly 30 is adapted to be detachably secured to the exterior surface 18 of the first garment sleeve 10 and it includes a valve stem 32 configured to detachably engage with the air input tube 16 on the exterior surface 18 of the first garment sleeve 10 for pressurizing the air chamber 12 of the first garment sleeve 10.

(18) Referring to FIGS. 4 and 5, the system further includes a second garment sleeve 20 that is adapted and configured to be wrapped around the right calf of the patient. Garment sleeve 20 has a compartmented air chamber 22 embossed or otherwise formed in an interior surface 24 thereof. Air chamber 22 which communicates with an air input tube 26 that is located on an exterior surface 28 of the garment sleeve 20.

(19) Garment sleeve 20 further includes an interior surface portion 33 that has three spaced apart fingers 35a-35c, each of which includes a respective hook type fastener pad 37a-37c for detachably engaging the exterior surface 18 of the garment sleeve 10 when it is wrapped around the right calf of the patient, as illustrated in FIG. 1.

(20) The second portable pump assembly 40 is adapted to be detachably secured to the exterior surface 28 of the second garment sleeve 20 and it includes a valve stem 42 configured to detachably engage the right-angled air input tube 26 on the exterior surface 28 of the second garment sleeve 20 for pressurizing the air chamber 22 in the second garment sleeve 20.

(21) Preferably, the interior surface 14, 24 of each garment sleeve 10, 20 is fabricated from a non-woven polyester material, the exterior surface 18, 28 of each garment sleeve 10, 20 is fabricated from a Nylex fabric, and a plurality of hook type fasteners are provided on an interior surface portion of each garment sleeve for detachably engaging the exterior surface of the garment sleeve. The garment sleeves are designed for one-size fits all use. They are washable and disposable.

(22) Referring now to FIG. 6, each portable pump assembly 30, 40 has a generally rectangular housing 50 defining an interior cavity that encloses a rechargeable battery 52 (e.g., a lithium ion battery) that supplies over 20 hours of treatment on a single charge, ensuring patients can be transported easily from the hospital to their homes. Battery charging is conducted through a charging port 59, which has an associated plug 69 attached to the housing 50 by a tether for sealing the charging port 59 when it is not in use.

(23) Each pump assembly 30, 40 includes an actuation button 55 for selectively turning the pump on and off. An LED indicator lamp 57 is connected to the actuation button 55 to provide information to the user. In addition, each pump assembly 30, 40 has an alarm feature to indicate a low battery power condition, and the system is designed to sound an alarm when the battery is at a critically low power state and shut down completely before battery damage occurs. The system is also designed to conserve battery power consumption.

(24) The housing 50 further encloses a pump 54, which is acoustically isolated within the housing 50 by an acoustic foam material 56. The housing 50 also encloses a control valve 58, which extends between the pump 54 and the valve stem 32, 42. Valve 58 is in communication with the manifold 68, and it closes at the start of each inflation cycle, and after a predetermined time period (e.g., 15 seconds of hold time), the valve 58 opens to exhaust the air from the garment sleeves 10, 20. The valve 58 will also act as a safety feature in the vent that the pressure in the garment sleeves 10, 20 exceeds a preset limit. At such a time, the pump 54 will be commanded to shut off and the solenoid valve 58 will open to relieve the over-pressure condition.

(25) Each portable pump assembly 30, 40 also has a processor circuit board 60 having a RISC-based microcontroller with ISP flash memory that is programmed to control battery usage and to command the pump 54 to inflate the air chamber 12, 22 in a respective garment sleeve 10, 20 to a preset pressure. The pump 54 will be commanded to shut off after the preset pressure is reached, and then after the predetermined period of hold time (e.g., 15 seconds) has ended, the solenoid valve 58 will be commanded to open and permit the air chamber 12, 22 to deflate.

(26) A pressure sensor 65 is operatively associated with the circuit board 60 for measuring pressure within the air chamber and for maintaining that pressure within specified limits. The pressure sensor 65 communicates with the air chamber 12, 22 by way of a sensing tube 67 that communicates with the valve stem 32, 34 by way of a manifold 68. If the pressure in the air chamber 12, 22 decreases below a preset limit during the predetermined hold time period, the pump 54 will be commanded to deliver air into the air chamber 12, 22 to increase the pressure therein back up to the preset value for the remainder of the hold time period. The inflation of the sleeves 10, 20 exert pressure on the calf muscles, which is the motive force enhancing the return of venous blood from the lower extremity to the heart, thereby preventing stasis in non-ambulatory people.

(27) The processor circuit board 60 in each portable pump assembly 30, 40 has a battery connector 51 that is electronically wired to the battery 52 and a pump connector 53 that is electronically wired to the pump 54. The microcontroller associated with the circuit board 60 is programmed to monitor battery state and command the functions of the pump 54. More particularly, the microcontroller is configured to command the pump 54 to inflate the air chamber 12, 22 in a respective garment sleeve 10, 20 to a pressure of 50 mm Hg+/−10 mm Hg and hold that pressure for approximately 15 seconds, after which the solenoid valve 58 will open to allow the air chamber 12, 22 to deflate and be without pressure for a dwell period of approximately 45 seconds.

(28) The electronic pressure sensing capabilities of the system also includes a low pressure alert feature, whereby a visual and/or auditory alert is provided and treatment will be stopped if an air leak occurs or other low pressure condition arises and the specified pressure (e.g., 30 mmHg) is not reached. The electronic pressure sensing capabilities of the system further includes a high pressure alert feature which prevents excessive pressure (e.g., greater than 75 mm Hg) in the inflatable garment sleeves. As noted above, in the event of an excessive pressure condition, the solenoid valve 58 will open to relieve the pressure.

(29) Each portable pump assembly 30, 40 includes a back cover plate 62 that is secured to the housing 50 by way of a plurality of threaded fasteners 63a-63c. The rear surface of the back cover plate 62 has a plurality of hook type fasteners disc 64a-64d for detachably securing the pump assembly housing 50 to the exterior surface 18, 28 of a garment sleeve 10, 20. Preferably, the air input tube 16, 26 on the exterior surface 18, 28 of each garment sleeve 10, 20 is mounted for rotational positioning with respect to the valve stem 32, 42 of a portable pump assembly 30, 40 associated therewith, to ease connectivity.

(30) The air input tube 16, 26 on the exterior surface 18, 28 of each garment sleeve 10, 20 is configured as a right angled tubular connector, as best seen in section 2A-2A of FIG. 2, and it is mounted to a flange 16a, 26a retained within the air chamber 12, 22 of the garment sleeve 10, 20 (see FIGS. 3 and 5). The air inlet tube 16, 26 is mounted to swivel or rotate relative to the flange 16a, 26a for ease of connectivity and it provides the ability to connect the garment sleeve 10, 20 to a bed mounted pump (not shown).

(31) As described and illustrated in further detail below, the system further comprises a power supply adapter for recharging the battery 52 enclosed within the housing 50 of each portable pump assembly 30, 40, and the garment sleeves 10, 20 are intended to be disposable while the portable pump assemblies 30, 40 are intended to be reusable. In this regard, the subject invention is also directed to a kit for facilitating the supply and return of the portable DVT treatment system described above.

(32) Referring now to FIG. 7, the kit 70 includes a left and right set of inflatable garment sleeves 10, 20 that are disposable, a pair a rechargeable battery powered pump assemblies 30, 40 for inflating the sleeves 10, 20 and that are reusable, a dual cord power supply adapter 72 for recharging the pump assemblies 30, 40 and that is reusable. The kit 70 also includes shipping carton 74 for returning the pump assemblies 30, 40 and the adapter 72 to a supplier after the patient is ambulatory and the risks of deep vein thrombosis have ended.

(33) The kit 70 further includes a tray 76 for packaging the pump assemblies 30, 40 and power supply adapter 72 in the shipping carton 74, and a supply carton 78 for initially delivering to the patient the set of garment sleeves 10, 20 and the shipping carton 78 enclosing the tray 76 containing the pump assemblies 30, 40 and the power supply adapter 72, together with a user manual (not shown).

(34) Referring now to FIGS. 8 through 11, to use the DVT treatment system of the subject invention, the patient will open the kit 70, as shown in FIG. 8, remove the two pump assemblies 30, 40 from the tray 76, and connect them to the dual cord power supply adapter 72 for charging, as shown in FIG. 9. Thereafter, the patient will wrap the right and left garment sleeves 10, 20 around their lower legs, as shown in FIG. 10, and connect the valve stems 32, 42 of each pump assembly 30, 40 to the respective air input tube 16, 26 of the inflatable garment sleeves 10, 20. Then, each pump assembly 30, 40 is detachably connected to the exterior surface of the garment sleeve 10, 20 using the fasteners pads 64a-64d on the rear surface of the pump housing 50, as depicted in FIG. 11. At such a time, each pump assembly 20, 40 can be activated by depressing actuation button 55.

(35) Each pump assembly 30, 40 of the DVT treatment system of the subject invention also includes an electronic compliance meter that stores and reports information on demand regarding a length of time that each pump assembly was in use. This allows the supplier to monitor and control its inventory of used pumps that have been returned in a reliable manner. The compliance meter is an audible reporting code that is incorporated into the processor circuit board 60 in each pump assembly 30, 40. The system is configured to store hours of usage for a significant period of time, such as, for example, up to 1000 hours.

(36) To determine the length of time the pump assembly was used, the user presses and holds the power button on the pump assembly for 10 seconds until they hear an audible beeping signal. The power button is then released, at which time the user would hear a long beep followed by a series of short beeps. Each series of short beeps represents a numeric or ordinal place holder.

(37) For example, if there is a long beep to indicate the start of the report, then 3 short beeps, a quick pause, followed by 5 short beeps, and then a long beep to indicate the end of the report, the user would determine that the pump assembly was used for 35 hours. The report can then be erased by pressing and holding the power button on the pump assembly for a longer period of time.

(38) Each pump assembly 30, 40 of the DVT treatment system of the subject invention is also adapted and configured to electronically sense the pressure in the air chamber 12, 22 of the respective garment sleeve 10, 20 with which it is associated electronically, which in turn activates the internal pump 54 to bring the sleeve to a correct pressure. Then, the system will hold the sleeve pressure for the full preset time (i.e., 15 seconds) before relieving the pressure for a period of 45 seconds.

(39) The electronic pressure sensing feature of the subject invention, which is provided by pressure sensor 65 on circuit board 60, differs from other products known in the art, which employ a spring loaded relief valve. In such devices, when the sleeve pressure reaches a preset limit, the relief valve opens to release the air in the sleeve bladder. Here, the pressure sensor 65 provides the control. Furthermore, the cycle time could be as short as 7-9 seconds, instead of a full 15 seconds, which is preferred. That is, the preferred cycle time for DVT prophylaxis devices is 15 seconds of pressure followed by 45 seconds of relief, which may be unmet by prior art devices with spring loaded relief valves.

(40) While the DVT treatment system of the subject disclosure has been shown and described with reference to a preferred embodiment, those skilled in the art will readily appreciate that changes and/or modifications may be made thereto without departing from the scope of the subject disclosure.