ES2806930T3 - Compression treatment system - Google Patents

Abstract

A compression treatment system (10) is provided that includes a first bladder (46a, 46b, 46c, 48a, 48b, 48c) supported about a limb. A second bladder is supported about the limb. The bladders are in fluid communication with a fluid source (50) and the bladders are inflated such that the first bladder is inflated for a first time period and the second bladder is inflated for a second time period. The second time period is initiated within the first time period. A single pressure sensor communicates with the first bladder and the second bladder.

Description

DESCRIPTION

Compression treatment system

Background

1. Technical field

The present invention relates generally to the field of vascular therapy for application to an extremity of a body and, more specifically, to a compression treatment system having a controller that regulates the flow of fluid.

2. Description of Related Art

A big problem for immobilized patients and people in similar condition are medical conditions that form blood clots, such as deep vein thrombosis (DVT) and peripheral edema. Such patients and individuals include those undergoing surgery, anesthesia, long periods of bed rest, etc. These blood clot-prone conditions generally occur in the deep veins of the lower extremities and / or the pelvis. These veins, such as the iliac, femoral, popiteal, and tibial, return deoxygenated blood to the heart. For example, when blood circulation in these veins slows down due to illness, injury, or inactivity, there is a tendency for blood to pool or stagnate. A static pool of blood is ideal for clots. A great risk associated with this condition is interference with cardiovascular circulation. More seriously, a piece of the blood clot can break off and migrate. A pulmonary thrombus can form, blocking a main pulmonary artery, which can be life-threatening.

The resulting conditions and risks associated with the patient's immobility can be controlled or alleviated by applying intermittent pressure to a patient's limb, such as, for example, a leg including the thigh, calf, and foot to aid blood circulation. . Known devices such as one-piece pads and compression boots have been used to aid blood circulation. See, for example, U.S. Patents Nos. 6,290,662 and 6,494,852.

For example, sequential compression devices have been used, which consist of an air pump connected to a disposable wrap pad via a series of air tubes. The wraparound pad is configured to be placed around a portion of a patient's leg, such as the thigh, calf, or foot. Multiple pads can be mounted on the leg to cover the different parts of the leg. Air is then sequentially blown into different parts of the pad or wrap pad, creating pressure around the thigh, calf, or foot, thereby enhancing venous return.

Document US 5575762 discloses a compression treatment system according to the preamble of claim 1. This discloses a gradient sequential compression system to prevent phlebothrombosis, which includes a pressure-based system controller to control air transfers from a source of pressurized air to the inflatable chambers of a limb sleeve so that prophylactic modality is provided to the limb. The system controller includes means for detecting low and high pressure failure states, which can occur due to disconnected or plugged lines and sleeves placed too loose or too tight around the limb.

GB 2295235 discloses an inflatable garment for applying compression to a patient's limb having two inflatable chambers for each limb. Both the lower and upper chambers are directly connected in succession to a common inflation source. A non-return valve prevents the first chamber from deflating when the second chamber begins to inflate. The pressure in the chambers is monitored by pressure transducers. A microprocessor is programmed to activate an alarm if the rate of pressure rise falls outside a predetermined threshold rate.

Document EP 1226804 (D3) discloses a pressure application apparatus comprising a compression sleeve with a plurality of inflatable annular cells, a control block with pneumatic valves, connected to said annular cells, and a source of pressurized fluid, connected to said control block, which is adapted to carry out, with said sleeve, a normal compression procedure. EP 1226804 discloses scanning of cells by applying little pressure to each cell. The scan detects the number of cells in the sleeve and adjusts the device's performance accordingly. The scan procedure is also used to detect malfunctioning cells.

These known devices can suffer various drawbacks due to their volume and the cumbersome nature of their use. These drawbacks reduce comfort, elasticity, and can disadvantageously impede patient mobility as recovery progresses after surgery.

In addition, these known sequential compression devices typically include a controller assembly that regulates air flow and pressure in the envelope pad (s). The controller assembly can be mounted on a bed and can be plugged into a wall outlet for power during use. However, this system can present challenges, for example, when the patient needs to perform certain tasks, for example, grooming, physical therapy, etc. In these situations, the pads are often removed, thus disadvantageously interrupting vascular therapy. Thus, these controller assemblies suffer from various drawbacks in that they do not facilitate patient transport or mobility and cannot normally be adapted for thigh, calf and foot pad inflation.

Therefore, it would be desirable to overcome the disadvantages and disadvantages of the prior art with a compression treatment system that has a controller that can be adapted to inflate thigh, calf, and foot sleeves and that facilitates transport or mobility of the patient to provide continuous vascular therapy. It would be desirable for the system to automatically detect the types of sleeves connected to it. It would be highly desirable for the system to include a pneumatic circuit that facilitates pressure monitoring with a single pressure transducer to achieve the advantages of the present invention. It is contemplated that the compression treatment system is easily and efficiently manufactured.

Summary

According to the invention, there is provided a compression treatment system according to claim 1.

Preferred embodiments of the present invention are defined in the dependent claims.

Brief description of the drawings

The present disclosure, in terms of its organization and its mode of operation, together with additional objectives and advantages, can be better understood by referring to the following description, taken in connection with the accompanying drawings, which are described below.

Figure 1 is a front view of a particular embodiment of a compression treatment system in accordance with the principles of the present invention;

Figure 2 is a side view of the compression treatment system shown in Figure 1;

Figure 3 is a plan view of the compression treatment system shown in Figure 1;

Figure 4 is a rear view of the compression treatment system shown in Figure 1;

Figure 5 is a schematic representation of a pneumatic circuit of the compression treatment system shown in Figure 1;

Figure 6 is a plan view of a sleeve of the compression treatment system shown in Figure 1 that is positioned around a limb;

Figure 7 is an alternative embodiment of the sleeve shown in Figure 6; Y

Figure 8 is an alternative example of the sleeve shown in Figure 6 not covered by the claims.

Detailed description of the example embodiments

The exemplary embodiments of the compression treatment system and the methods of operation presented are explained in terms of vascular therapy including a compression apparatus with prophylaxis for application to a limb of a body and, more specifically, in terms of a system. compression treatment that has a controller that can be adapted to inflate thigh, calf, ankle and foot sleeves and that facilitates the transport and mobility of the patient. It is contemplated that the compression treatment system may be employed to avoid and overcome the risks associated with immobility of the patient. It is further contemplated that the compression treatment system alleviates the conditions resulting from the immobility of the patient to prevent, for example, DVT, peripheral edema, etc. It is contemplated that the compression treatment system according to the present invention can be attributed to all types of venous compression systems, including an apparatus for sequential compression with prophylaxis, but not limited to such apparatus. The term "sequential with prophylaxis" should not be considered limiting to the general venous compression treatment system described herein. However, it is envisioned that the present invention will find application with a wide variety of immobility conditions of people and similar patients, such as, for example, those who are subjected to surgery, anesthesia, long periods of bed rest, who suffer obesity, old age, cancer, previous thromboembolism, etc.

In the discussion that follows, the term "proximal" refers to a portion of a structure that is closer to the trunk of a subject and the term "distal" refers to a portion that is further from the trunk. As used herein, the term "subject" refers to a patient who undergoes vascular therapy using the compression treatment system. In accordance with the present invention, the term "healthcare personnel" refers to an individual who administers the compression treatment system and may include support personnel.

The following explanation includes a description of the compression treatment system, followed by a Description of an exemplary method of actuation of the compression treatment system in accordance with the principles of the present invention. Reference will now be made in detail to the exemplary embodiments and the invention, which are illustrated with the accompanying figures.

Reference will now be made to the figures, in which throughout the different views like components are designated by like reference numerals. Referring initially to Figures 1-5, there is illustrated a compression treatment system 10 constructed in accordance with the principles of the present invention. The compression treatment system 10 includes a housing 12. The housing 12 contains the components of a controller 14 (shown schematically in Figure 5) located within it.

The housing 12 is semi-circular in configuration and has a handle cutout 16 along its top 18 to facilitate transportation and mobility of the subject. It is envisaged that the housing 12 can be configured and dimensioned in different ways such as, for example, rectangular, spherical, etc. It is further envisioned that the housing 12 can be assembled by any appropriate process such as, for example, snap fit, adhesive bonding, solvent welding, heat welding, ultrasonic welding, screws, rivets, etc. Alternatively, housing 12 can be formed in one piece or integrally assembled from multiple housing sections and can be substantially transparent, opaque, etc. The housing 12 can include ribs, ridges, etc. to facilitate handling of the compression treatment system 10.

The components of the housing 12 may be made of a material suitable for medical applications, such as, for example, polymers or metals, such as stainless steel, depending on the particular medical application and / or the preference of a physician. Semi-rigid and rigid polymers, as well as elastic materials, such as molded medical-grade polypropylene, are contemplated for fabrication. However, one of ordinary skill in the art will realize that other materials and other suitable fabrication methods for assembly and fabrication would also be appropriate in accordance with the present invention.

Housing 12 is portable to facilitate continuous vascular therapy to a subject (not shown). Housing 12 includes a bracket 20 that facilitates non-permanent mounting of housing 12 in, for example, a hospital bed, table, etc. Bracket 20 extends from a rear portion 22 of casing 12 and provides a hooked configuration for hanging casing 12 from a subject's bed, etc. It is contemplated that the bracket 20 can be hung from different structures for non-permanent mounting of the housing 12 or, alternatively, that the housing 12 does not include a bracket and can be placed on the floor or other supporting surface. Alternatively, the housing 12 includes a shoulder strap 24, as shown in Figure 2, which allows the housing 12 to be carried by the subject or by healthcare personnel during transportation. Shoulder strap 24 can be used with or without bracket 20 and can be attached to, for example, any part of housing 12, including handle 16.

The compression treatment system 10 uses an AC / DC switching electrical power source for the operation of its components. A power cord 26 is connected to the housing 12 to carry power to the components of the controller 14. The power cord 26 accesses an AC power source through a wall outlet, etc. Controller 14 may include a transformer or other electronic components to connect to the power source. It is envisaged that the power cord 26 can be wrapped around the holder 20 for storage and during transportation and mobility of the subject. It is further envisioned that the compression treatment system 10 may include a storage capture mechanism that retains the power cord 26 with the housing 12. The storage capture mechanism may include a bungee cord, pulley, and the like.

The compression treatment system 10 also uses a battery 28 to power the components of the controller 14 to facilitate transportation and mobility of the subject. Battery 28 is located within a battery compartment 30 of housing 12. It is contemplated that battery 28 may include one or a plurality of cells. Battery cells can be lithium-ion type, etc. It is further contemplated that the battery 28 is rechargeable and can be used for different ranges of operating time, such as, for example, 6 hours, 8 hours, 10 hours, etc. For example, power cord 26 can be unplugged and captured by the casing storage capture mechanism 12. Compression treatment system 10 is then powered by battery 28 and the subject can be moved.

It is envisaged that the battery 28 can be mounted on or independent of an outer surface of the housing 12. It is further envisioned that the compression treatment system 10 may include alternative energy sources, such as, for example, solar energy, non-electric energy, etc., or alternatively may not include battery power.

The housing 12 has a control panel 32 located on a front surface 34 thereof. Control panel 32 includes controls and indicators for operating the compression treatment system 10. Control panel 32 has an LED display 36 that provides status data, messages, and the like. of the different components of the system 10, such as, for example, power, battery, identification and connection of the sleeve, inflation, air outlet, venous filling, errors, etc. Control panel 32 also includes manual override switches to power the system 10, etc. Such switches are contemplated to be of the membrane type actuated by finger pressure, etc.

Rear portion 22 of housing 12 defines holes 38, 40 (Figure 4). Ports 38, 40 include outlet ports 38a, 38b, 38c and outlet ports 40a, 40b, 40c, respectively. Outlet ports 38a, 38b, 38c and outlet ports 40a, 40b, 40c are in fluid communication with inflatable chambers 46a, 46b, 46c of a compression sleeve 46 and with inflatable chambers 48a, 48b, 48c of a sleeve 48 compression braces, respectively, which are configured to fit around a subject's legs, by means of a female connector 42 and a set 44 of tubes, as will be explained. The outlet ports 38a, 38b, 38c, 40a, 40b, 40c are configured for connection to the tube assembly 44. Each of the holes 38, 40 can be connected to a particular compression sleeve, for example, a leg sleeve, a foot sleeve, etc.

Ports 38, 40 are also connected to components of controller 14 located within casing 12 to facilitate inflation of selected compression sleeves, as illustrated in the pneumatic circuitry shown in Figure 5. Controller 14 includes a pressurized fluid source, such as, for example, a pump 50 fluidly communicating with a valve block 52 for connection to ports 38, 40, as will be explained. Pump 50 includes a motor that compresses air and sends it to valve block 52 through pipes or the like. The speed of the pump motor is electronically controlled to provide a corresponding compressor speed for the respective desired outlet pressures. It is contemplated that a power supply board, including the electronics, circuitry, software, etc. necessary known to a person skilled in the art, is connected to the pump motor and other components of the controller 14 to regulate the energy transmitted thereto. It is envisioned that the pump 50 could be a membrane pump.

Controller 14 also includes a non-return valve 54 that prevents return of air through pump 50 when bag pressure is monitored during detection of venous filling, as will be explained. An overpressure valve 56 is provided with the pneumatic circuit to protect against overpressure in the compression sleeves. The overpressure valve 56 is configured to release air pressure if necessary. It is contemplated that different types of valves may be employed such as, for example, spring loaded tappet valves, etc.

Valve block 52 includes solenoid valves 58a, 58b, 58c, 60a, 60b, 60c that are coupled to ports 38a, 38b, 38c, 40a, 40b, 40c, respectively. Each of the solenoid valves 58a, 58b, 58c, 60a, 60b, 60c has an associated solenoid that is electrically actuated by means of a controller control processor 14. The solenoid is coupled to a valve seat of each valve. solenoid 58a, 58b, 58c, 60a, 60b, 60c such that the seat acts to open and close the respective solenoid valve when the solenoid is actuated. See, for example, the solenoid valves described in U.S. Pat. No. 5,876,359 issued to Bock et al. Controller control processor 14 is contemplated to include electronics, circuitry, software, etc. necessary, known to a person skilled in the art, to actuate solenoid valves 58a, 58b, 58c, 60a, 60b, 60c in response to varying conditions of the compression treatment system 10 and in response to other prompts and measurements captured by the components of the controller 14. It is envisioned that one or a plurality of solenoid valves may be employed or, alternatively, that other types of valves may be used.

Solenoid valves 58a, 58b, 58c, 60a, 60b, 60c and associated valve components are mounted in ports 38, 40 inside housing 12. Solenoid valves 58a, 58b, 58c, 60a, 60b, 60c are two position three-way normally closed valves, which have openings 62a, 62b, 62c, 64a, 64b, 64c, respectively. In the open position, air flows through openings 62a, 62b, 62c, 64a, 64b, 64c into associated outlet orifice 38a, 38b, 38c, 40a, 40b, 40c and into chambers 46a, 46b, 46c of the compression sleeve 46 and into the inflatable chambers 48a, 48b, 48c of the compression sleeve 48. In the closed position, the openings 62a, 62b, 62c, 64a, 64b, 64c are blocked and the air from the compression sleeves 46, 48 returns through the outlet port 38a, 38b, 38c, 40a, 40b, 40c and through the air outlet ports 66a, 66b, 66c, 68a, 68b, 68c of the associated valve to deflate the inflatable chambers 46a, 46b, 46c, 48a, 48b, 48c.

Solenoid valves 58a, 58b, 58c, 60a, 60b, 60c are actuated sequentially to pressurize inflatable chambers 46a, 46b, 46c, 48a, 48b, 48c and to provide sequential pressurization thereof and air venting. chambers under the control of the controller control processor 14. It is contemplated that solenoid valves 58a, 58b, 58c, 60a, 60b, 60c may be selectively actuated when sleeve cooling operation is desired, see for example US Patent No. 5,876,359 issued to Bock et al.

Solenoid valves 58a, 58b, 58c, 60a, 60b, 60c are actuated by pulse width modulated signals sent by controller control processor 14. Solenoid actuation signals initially have a high energy level for a fast and safe actuation of solenoid valves. After initial actuation, actuation signals can be reduced, for example, by about 70% to maintain actuation of the valves, thereby reducing energy consumption. It is envisioned that solenoid valves 58a, 58b, 58c, 60a, 60b, 60c can be deactivated when desired. It is further envisioned that the controller control processor 14 includes the ability to verify the status of valves 58a, 58b, 58c, 60a, 60b, 60c solenoid. As the condition of the solenoid valves 58a, 58b, 58c, 60a, 60b, 60c changes, the control processor verifies their condition. For example, if a particular valve is detected to be shorted or open, the compression treatment system 10 will enter a particular error mode, as will be explained.

Controller 14 also includes a pressure transducer 66 located within housing 12. Pressure transducer 66 is coupled to the pneumatic circuit and located between pump 50 and valves 58a, 58b, 58c, 60a, 60b, 60c of solenoid through pipes or similar. Pressure transducer 66 is in fluid communication with inflatable chambers 46a, 46b, 46c, 48a, 48b, 48c to monitor the pressure in each of these inflatable chambers 46a, 46b, 46c, 48a, 48b, 48c. Controller control processor 14 instructs pressure transducer 66 to measure any of the inflatable chambers 46a, 46b, 46c, 48a, 48b, 48c that are connected to their respective solenoid valve and therefore in communication. fluent with her. Positioning the pressure transducer 66 before the solenoid valves, on the manifold side of the pneumatic circuit, advantageously facilitates the use of a single pressure transducer to measure the pressure in the inflatable chambers. This configuration facilitates the inflation of one of the inflatable chambers or of the plurality of them. Advantageously, this configuration also reduces the bulk of the controller 14 to contribute to a compact and lightweight design of the compression treatment system 10, facilitates patient transport and mobility, and reduces manufacturing costs.

For example, during a selected compression cycle, solenoid valves 58a, 58b, 58c, 60a, 60b, 60c are selectively energized to their open position to sequentially pressurize chambers 46a, 46b, 46c, 48a, 48b, 48c inflatable. In the open position, solenoid valves 58a, 58b, 58c, 60a, 60b, 60c allow air from pump 50 to pass through respective outlet ports 38a, 38b, 38c, 40a, 40b, 40c to inflatable chambers. Pressure transducer 66 monitors the pressures in each of the inflatable chambers 46a, 46b, 46c, 48a, 48b, 48c of the pneumatic circuit and provides the controller control processor 14 with an electrical signal input for feedback control.

At the end of the selected compression cycle, solenoid valves 58a, 58b, 58c, 60a, 60b, 60c are simultaneously de-energized by moving to the closed position to disconnect pump 50 from hoses 46, 48. In the closed position, air of pump 50 is blocked and solenoid valves 58a, 58b, 58c, 60a, 60b, 60c release pressure from the hose to atmosphere through ports 66a, 66b, 66c, 68a, 68b, 68c of the block 52 of valves. It is contemplated that the compression treatment system 10 may alternate the inflation of the chambers between a first end and a second end. It is further contemplated that the compression treatment system 10 can individually inflate each of the bags.

Referring to Figure 6, compression treatment system 10, similar to that described above, is assembled and ready for use. During operation, the compression treatment system 10 includes a controller 14 provided with the housing 12, described above, and a sleeve 112. The sleeve 112 includes a thigh bag 114, a calf bag 116, and a bag 118 for the ankle. Sleeve 112 includes a connector 120 that mates with female connector 42, which is connected to port 38 through tubing 44. Connector 120 fluidly communicates with the chambers of sleeve 112 through tubing assembly 122 . Thus, this configuration facilitates fluid communication between bags 114, 1166, 118 and pump 50. It is contemplated in this invention that connector 120 may further include a valve mechanism to control fluid flow.

Sleeve 112 is provided and manipulated for placement around the subject's leg L (not shown). Connector 120 mates with female connector 42 to establish fluid communication between sleeve 112 and the pneumatic circuit. The sleeve 112 wraps around the leg L and is attached to it by means of velcro straps 124, 126. It is contemplated that the compression treatment system 10 may treat a second leg of a subject with a compression sleeve, similar to sleeve 112, through connection to port 40. The second leg is treated in alternate compression cycles to the compression cycles described below for the treatment of leg L, as described below in the alternative embodiment.

The portable features of the housing 12 and controller 14, described above, provide a compression treatment system 10 that facilitates transportation and mobility of the subject. This advantageous configuration provides uninterrupted DVT prophylaxis when the system is used throughout an entire treatment facility, and can be carried and used continuously by the subject throughout the risk period. The compression treatment system 10 advantageously facilitates continuous vascular therapy during the subject's activity and tasks such as, for example, transportation for testing, grooming, physical therapy, etc. The compression treatment system 10 avoids therapy interruptions by providing a controller 14 that will operate on battery 28 when power cord 26 is not plugged in, and will also be comfortable, compact, and light enough to move with the subject. when necessary.

The manual override switches on the control panel 32 of the controller 14 turn on the compression treatment system 10 for operation. When the compression treatment system 10 is initially turned on, the controller control processor 14 performs a series of self-diagnostics. The LED indicators on the display 36 are illuminated and acoustic signals are sounded to verify the operability of the visual and audible indicators. The display 36 is illuminated to verify the operability of the display. Controller 14 also verifies the operability of the control processor software. If any of the checks fail, error codes provide audible and / or visual signals.

It is contemplated that if the controller control processor 14 cannot continue with normal software execution, an error code will be triggered. This causes the compression treatment system 10 to reset and resume normal operation. The sleeve 112 would let air out during a reset procedure. Audible and visual signals can also be activated to represent the condition.

Upon completion of the compression of the treatment system 10 self-diagnostic sequence, the controller 14 begins a sleeve detection procedure to determine the type or types of sleeves attached to the holes 38, 40. The sleeve detection is performed. during a first inflation (detection) cycle after the controller is initially powered up. During the detection cycle, air is alternately supplied through ports 38, 40 by operating pump 50 for two seconds, or until pressure reaches a default threshold. One second later, pressure transducer 66 takes a pressure measurement to determine whether or not a bag is connected to a particular outlet port 38a, 38b, 38c, 40a, 40b, 40c upon which detection of pressure is being performed. the sleeve.

For example, the detection procedure for bags 114, 116, 118 is performed for each of the holes 38, 40 in the sleeve. If there is no back pressure at a particular outlet port for connection to a bag, then the controller's control processor 14 determines that a bag with that particular outlet port is not being used. The control processor adjusts the compression therapy for the sensed sleeve configuration accordingly. For the 3-bag sleeve, back pressure is detected in bags 114, 116, 118 when connected to controller 14. It is contemplated that, if sleeves are not detected by this procedure in either port 38 or 40, or if not the detected configuration is recognized, then a low pressure error is triggered with corresponding acoustic signals. It is further contemplated that different timing periods may be used for inflation detection and pressure measurement, according to the needs of a particular application.

Alternatively, thigh bag 114 can be detached from calf bag 116. For example, calf bag 116 is non-permanently connected to thigh bag 114 by means of a perforated attachment, see, for example, the sleeve described in U.S. Patent Application. Serial No. 10 / 784,607, filed February 23, 2004 and entitled "Compression Apparatus." For the removable thigh bag 114, the controller control processor 14 performs a sleeve detection procedure similar to that described above. The control processor will detect a 3-bag sleeve due to a flow restriction valve (not shown) coupled to connector 120. See, for example, the flow restriction valve described in U.S. Patent Application Serial No. Serial No. 10 / 784,639, filed February 23, 2004, entitled "Fluid Conduit Connector Apparatus." The flow restriction valve simulates the back pressure created by thigh bag 114 when no bag is actually connected. In this way, converting a 3-bag thigh-length sleeve to a 2-bag knee length sleeve does not have a significant impact on compression parameters, and controller 14 continues vascular therapy as if bag 114 for the thigh was still intact.

In an alternative embodiment, as shown in Figure 7, the sleeve 112 includes a thigh bag 114 and a second unitary bag 218. The second bag 218 has a calf portion 220 and an ankle portion 222. The pump 50 communicates fluidly with the sleeve 112 through a separate valve connector 224 and tubing 226, 228, for use similar to that described above, including the optional removal of the thigh bag 114 via of perforations or similar.

In a particular compression cycle for the compression treatment system 10, the compression parameters include an inflation period of 11 seconds to inflate the bags 114, 116, 118 followed by 60 seconds of air release to deflate the bags 114, 116, 118. The 11-second inflation period is sequential:

1) Initially, the ankle bag 118 is inflated for a first period of time beginning at 0 seconds;

2) after that and during the first period of time, the inflation of the calf bag 116 is started for a second period of time, the start of the second period of time coinciding with approximately 2.67 seconds of duration of the first period of time;

3) thereafter and during the second period of time, inflation of the thigh bag 114 is initiated for a third period of time, with the third period of time beginning after approximately 3.0 seconds duration of the second period of time and after about 5.67 seconds of the first time period; Y

4) After 11 seconds of the first time period, the bags 114, 116, 118 let out air for a minimum of 20 seconds and a maximum of 60 seconds. An example is illustrated in Table 1 below.

Table 1

It is contemplated that the period of air release is measured from the end of one inflation cycle to the beginning of the next inflation cycle in leg L. It is further contemplated that both extremities of the subject may be treated and that the treatment system for compression 10 alternate vascular therapy from leg L to second leg. It is envisaged that the period of time from the end of the inflation cycle for leg L to the start of the inflation cycle for the second leg may range, for example, from 4.5 to 24.5 seconds.

During the initial inflation cycle for the L-leg treatment, as described above, the pump 50 starts with a low default voltage so as not to over-inflate the bags 114, 116, 118 in the initial cycle. Solenoid valves 58a, 58b, 58c are energized to the open position, as described, such that the valves open to send air to ankle bags 118, then to bag 116 for delivery. calf, then to thigh bag 114 of sleeve 112 using a desired cycle timing sequence. Pressure transducer 66 monitors the pressure in each of the bags 114, 116, 118 throughout the 11 second compression cycle. When the inflation cycle is complete, pump 50 is stopped and solenoid valves 58a, 58b, 58c are de-energized to the closed position to allow bags 114, 116, 118 to deflate through ports 66a, 66b, 66c air outlet.

It is envisaged that, if a second leg of the subject is treated with vascular therapy, the solenoid valves 60a, 60b, 60c will be energized by moving to the open position, as described, such that the valves are opened to supply air to corresponding bags of a sleeve located around the second leg, similar to sleeve 112, using a desired cycle timing sequence. Pressure transducer 66 monitors the pressure in each of the corresponding bags throughout the 11 second compression cycle. Upon completion of the inflation cycle, pump 50 is stopped and solenoid valves 60a, 60b, 60c are de-energized to the closed position to allow the corresponding bags to deflate through outlet ports 68a, 68b, 68c. air. It is further envisaged that the inflation cycle for the treatment of the second leg can be started approximately 24.5 seconds after the completion of the inflation cycle for the treatment of leg L. This process can be repeated for cycles belonging to both legs. . Other cycle times are contemplated.

In this embodiment, the pressures measured by the pressure transducer 66 and the corresponding signal transmitted to the control processor of the controller 14, of the bags 114, 116, 118 during the inflation cycle remain staggered with the pressure of the bag 118 being for the ankle greater than the pressure of calf bag 116, and the pressure of calf bag 116 being greater than the pressure of thigh bag 114. End-of-cycle pressures, for example, include 45 mmHg in ankle bag 118, 40 mmHg in calf bag 116, and 30 mmHg in thigh bag 114. An example is illustrated in Table 2 below. Compression is contemplated to continue in this cyclical pattern until compression treatment system 10 is turned off or controller 14 indicates an error code via acoustic or visual signals. Other cycle pressures are contemplated.

For inflation cycles subsequent to the initial inflation cycle for leg L, already described, a pressure feedback adjustment can be made according to the pressure measurement taken by the pressure transducer 66. At the end of the initial inflation cycle for leg L, the end-of-cycle pressure in ankle bag 118 is measured by pressure transducer 66 and compared by controller control processor 14 to the set pressure of 45 mmHg. If the pressure of the ankle bag 118 is greater or less than the set pressure, then a corresponding increase or decrease in the speed of the pump 50 is necessary to reduce or increase the pressure delivery. The pump speed setting is based on the following calculation:

Fit = | 45 - P |, where P = pressure at the ankle

If the pressure is less than the set pressure, then the pump speed for the next cycle is increased by the amount of adjustment. If the pressure is higher than the set pressure, then the pump speed for the next cycle is reduced by the amount of adjustment. It is contemplated that the adjustment process will continue even after the set pressure range has been reached. It is further contemplated that compression treatment system 10 may be adjusted to provide different pump speeds for each hose connected to controller 14. Other sequential compression cycles are also contemplated.

In an alternative example the compression treatment system 10 performs a measurement of the venous fill time. Venous fill time (VRT) measurement is an air plethysmographic technique that determines when the veins in a limb have completely filled with blood after a compression cycle. See, for example, the measurement of venous filling time described in U.S. Pat. No. 6,231,532 issued to Watson et al. VRT minimizes the amount of time that blood remains stagnant within the veins. The VRT will be replaced by the default rest time (60 seconds) whenever said VRT is between 20 and 60 seconds. If the VRT is less than 20 seconds then the default value of 20 seconds is used. If the VRT is greater than 60 seconds then the maximum of 60 seconds is used. The VRT measurement is performed when the system first reaches the set pressure and once every 30 minutes thereafter. It is contemplated that the VRT algorithm and technique can be used for both sleeve compression and foot compression.

The VRT measurement uses an air plethysmographic technique in which little pressure is applied to the calf bags. As the veins fill with blood, the pressures in the calf bags increase until a plateau is reached. The time it takes for pressure to plateau is the VRT. If two sleeves are connected to the controller 14, then the VRT for each limb being compressed is determined separately and the larger of the two measurements is used as the new air outlet time of the compression cycle. The VRT measurement for each sleeve is carried out according to each specific sleeve independently reaching the established pressure. However, the air release time is not updated until the VRT measurements for both runs have been calculated.

For example, compression treatment system 10 can use the VRT measurement after the system has initiated vascular therapy. Subsequently, after 30 minutes have passed, a VRT measurement will be taken at the next full inflation cycle. After any of the above-described sleeves is inflated, all air is released from the bag (s) of the particular sleeve as in the default inflation cycle.

It is contemplated that the pressure of a selected bag is monitored and that the air outlet of the bag closes when the pressure drops to 5-7 mmHg. If the pressure in the bag is 5-7 mmHg in a more recent cycle then a VRT measurement is taken. If the pressure in the bag does not drop to 5-7 mmHg then the vent time will remain at its most recent value and another measurement will be taken in 30 minutes. If an error occurs, a corresponding alarm provides acoustic and / or visual signals.

The VRT measurement algorithm determines when pressures in selected bags plateau after compression. The VRT will be determined independently for the two legs. The greater of the two fill times will be used as the new air outlet time. If compression is applied to only one leg, the VRT for that leg is used as the new air outlet time. The VRT measurement algorithm is started by starting a timer from the end of the inflation cycle, which occurs after the selected bag reaches 5-7 mmHg (enough pressure to make the bag stay in contact with the surface). leg) and the air outlet stops. The VRT measurement is started by starting the timer from the end of the inflation cycle.

The pressure in the selected bag is then monitored. By way of example, pressure is monitored with a moving 10-second sampling window. The window moves in 1 second intervals. The curve has reached its plateau when the difference between the first and last values in the window is less than approximately 0.3 mmHg. The VRT measurement is considered done, and the time interval is determined. The end of the window is considered to be the point at which the venous system of the extremities has filled.

Regardless of the VRT measurement, the air is released from the selected bag for 15 seconds before starting the next compression cycle on that same limb. As a safety factor, 5 seconds are added to the measured fill time so that the limb is not compressed too soon. The air outlet time is contemplated to be equivalent to the measured fill time plus 5 seconds. For example, as a result of patient movement, the standard deviation in the sampling window may be too large, making the measurement wrong. At this point, the calculation is discarded and the old VRT value is used. The VRT measurement is considered erroneous if at any time during the measurement, the pressure in the selected bag is less than 2 mmHg, the calculation is discarded, and the old VRT value is used. This can happen if there is a leak in the system. It is contemplated that the old VRT value will be used if the pressure is greater than 20 mmHg at any time during the VRT measurement. It is further contemplated that, if the VRT calculation is performed for both legs, the higher VRT of the two legs is used. It is expected that if the VRT is calculated to be greater than 60 seconds, a value of 60 seconds will be used. If the VRT is calculated to be less than 20 seconds, a value of 20 seconds is used.

Alternatively, compression processing system 10 may use one, a plurality, or all of the following error codes to provide acoustic and / or visual signals of system error or failure. Advantageously, these features increase safety for the subject during vascular therapy. Various error conditions can cause the compression treatment system 10 to alarm and stop a particular compression cycle. It is contemplated that the compression treatment system 10 can do flash error indicators, generate continuous audible signals, etc., causing a user to reset the compression treatment system 10. Controller 14 may provide an error alarm for one, for a plurality, or for all of the following error conditions: high pressure error, which includes those pressures detected above the set pressure; low pressure error, which includes those pressures detected below the set pressure and if no sleeves are detected; system pressure error, including pressure determined within an inflation cycle outside of desired parameters; valve error, software error; pump error; air outlet and deflation error, battery error; and temperature error, which includes sensed temperatures outside of specified ambient conditions.

In an alternative example not covered by the claims, such as that shown in Figure 8, the compression treatment system 10, similar to that described above, includes a foot sleeve 312 configured to provide vascular therapy to the subject's foot. The foot sleeve 312 includes a bag 314 that is inflated with air to provide an application of pressure to the foot and then deflated. See, for example, the sleeve described in U.S. Patent Application Serial No. No. 10 / 784,604, filed on February 23, 2004 and entitled "Compression Apparatus".

The pump 50 communicates fluidly with the foot sleeve 312. Sleeve 312 includes a connector 316 that mates with female connector 42, which is connected to port 40 through tube 44. Valve connector 316 communicates fluidly with bag 314 of sleeve 312 through tube 318. Thus, this configuration facilitates fluid communication between bag 314 and pump 50. Foot sleeve 312 wraps around the lateral portions of the foot by means of a Velcro-type connecting flap 320 that crosses the instep. of the foot and an ankle strap 322 with a velcro connection.

Upon completion of the compression of the self-diagnostic sequence for the treatment system 10, similar to that described, the controller 14 begins the sleeve detection procedure to determine the type or types of sleeves attached to the holes 38, 40. Regarding the foot sleeve 312, the back pressure is detected by the control processor of the controller 14 corresponding to the bag 314, which is connected to the outlet port 40b. It is contemplated that the compression treatment system 10 can treat a subject's second leg foot with the foot sleeve 312 and also treat the L leg, as described above, in alternate inflation cycles.

In a particular example compression cycle for foot sleeve 312, compression parameters include a 5 second inflation period followed by 60 seconds of air release. An example is illustrated in Table 3 below.

T l

It is contemplated that the period of air release from the end of one inflation cycle to the beginning of the next inflation cycle is measured on the subject's foot. It is further contemplated that both extremities of the subject may be treated and that the compression treatment system 10 alternates vascular therapy from leg L to second leg. The time period from the end of the inflation cycle for leg L to the start of the inflation cycle for the second leg is expected to be 7.5-27.5 seconds.

During the initial inflation cycle for treatment of the subject's foot, as described above, the pump 50 starts with a low default voltage so as not to over-inflate the bag 314 in the initial cycle. Solenoid valve 60b is energized to the open position, as described, such that the valve opens to send air to bag 314 using a desired cycle timing sequence. Pressure transducer 66 monitors the pressure in bag 314 throughout the 5 second compression cycle. Upon completion of the inflation cycle, pump 50 is stopped and solenoid valve 60b is de-energized to the closed position to allow bag 314 to deflate through air outlet port 68b.

It is envisaged that, if a second foot of the subject is treated with vascular therapy, the solenoid valve 58b 58b will be energized to the open position, as described, such that the valve opens to send air to a corresponding bag. of a foot sleeve wrapped around the other leg, similar to foot sleeve 312, using a desired cycle timing sequence. For example, pressure transducer 66 monitors the pressure in the corresponding bag throughout the 5 second compression cycle. Upon completion of the inflation cycle, the pump 50 is stopped and the solenoid valve 58b is de-energized to the closed position to allow the corresponding bag to deflate through the air outlet port 66b. It is further envisioned that the inflation cycle for treating the second foot can be started approximately 27.5 seconds after the completion of the inflation cycle for treating the foot treated by the foot sleeve 312. This process can be repeated for cycles pertaining to both feet or, alternatively, for a sleeve for the foot of a first leg and a sleeve for the leg of a second leg. It is contemplated that the compression treatment system 10 can provide alternating compression to any combination of a sleeve and a foot cover and that, If this combination is used, then, for example, add an additional 6 second airflow margin or time to all airflow periods after the inflation cycle for the foot, such that the total time is consistent with the default sleeve compression parameters. Other cycle times are contemplated.

In this embodiment, the target pressure, measured by pressure transducer 66 and the corresponding signal transmitted to controller control processor 14, of bag 314 is, for example, 130mmHg. Compression is contemplated to continue in this cyclical pattern until compression processing system 10 is turned off or controller 14 indicates an error code via acoustic or visual signals.

For inflation cycles subsequent to the initial inflation cycle for the foot sleeve 312 described, a pressure feedback adjustment can be made in accordance with the pressure measurement taken by the pressure transducer 66. After completion of the inflation cycle initial for foot sleeve 312, pressure transducer 66 measures end-of-cycle pressure in bag 314 and controller control processor 14 compares it to the set pressure of 130 mmHg. If the pressure of the bag 314 is greater or less than the set pressure, then a corresponding increase or decrease in the speed of the pump 50 is necessary to increase or decrease the pressure delivery. The setting of the pump speed is based on the following calculation:

Setting = | 1130 - P |,

where P = pressure in the foot

If the pressure is less than the set pressure, then the pump speed for the next cycle is increased by the amount of adjustment. If the pressure is higher than the set pressure, then the pump speed for the next cycle is reduced by the amount of adjustment. It is contemplated that the adjustment process will continue even after the set pressure range has been reached. It is further contemplated that compression treatment system 10 can be adjusted for independent pump speeds for each hose connected to controller 14. Other sequential compression cycles are also contemplated.

It will be understood that various modifications can be made to the embodiments presented herein. Therefore, the above description should not be considered as limiting, but only an example of the different embodiments. Those skilled in the art will envision other modifications within the scope of the claims appended to this patent.

Claims (3)

1. A compression treatment system (10) comprising: a pump (50) as a source of fluid; a sleeve (46, 48) including several bags (46a, 46b, 46c, 48a, 48b, 48c) adapted to be clamped around an end and in fluid communication with the fluid source; a housing (12) including a control panel (32), ports (38, 40) and said pump, solenoid valves (58, 60) (58, 60) in fluid communication with the pump (50) to selectively pass or block a flow of fluid from the pump (50) to the bags; a pressure transducer (66); a pneumatic circuit to allow the inflation of the bags (46a, 46b, 46c, 48a, 48b, 48c) and the pressure monitoring using the pressure transducer (66), where: the pressure transducer (66) is coupled to the pneumatic circuit and is arranged between the pump (50) and the solenoid valves (58a, 58b, 58c, 60a, 60b, 60c) through tubes; characterized by a control processor in the housing (12) in communication with the control panel (32), the pump (50) and the solenoid valves (58, 60) to control the operation of the pump (50) and the valves (58, 60), the control processor being programmed to execute a sleeve detection procedure during a first inflation cycle, after the control processor (14) has initially been turned on and after the sequence of self-diagnosis, including the sleeve detection procedure the following stages: a) supplying air through the orifices (38, 40) with the pump (50) until the pressure reaches a default threshold; b) taking a pressure measurement with the pressure transducer (66) to determine whether or not a bag (46, 48) is connected to an orifice (38a, 38b, 38c, 40a, 40b, 40c) in particular after detection of the sleeve; c) determining that a bag (46a, 46b, 46c, 48a, 48b, 48c) is not connecting to an orifice (38a, 38b, 38c, 40a, 40b, 40c) in particular if there is no back pressure; d) detecting which ports are connected and determining what type of sleeve (46, 48) is connected, and e) adjusting the appropriate compression therapy accordingly. 2. The compression treatment system according to claim 1, characterized by what the sleeve type (46, 48) is a leg sleeve or a footwear. 3. The compression treatment system according to claims 1 or 2, characterized by what the control processor executes an additional stage in which a low pressure error is triggered with the corresponding acoustic signals if no sleeves (46, 48) are detected in the orifices (38, 40) or if the detected type is not recognized.