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WO2005097020A1 - Dispositif et procede pour le traitement d'oedeme - Google Patents

Dispositif et procede pour le traitement d'oedeme Download PDF

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Publication number
WO2005097020A1
WO2005097020A1 PCT/US2004/007523 US2004007523W WO2005097020A1 WO 2005097020 A1 WO2005097020 A1 WO 2005097020A1 US 2004007523 W US2004007523 W US 2004007523W WO 2005097020 A1 WO2005097020 A1 WO 2005097020A1
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WO
WIPO (PCT)
Prior art keywords
liquid
bladder
therapeutic pad
pad
flow
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/US2004/007523
Other languages
English (en)
Inventor
Richard Diana
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
PRO TRAINERS' CHOICE Co
Original Assignee
PRO TRAINERS' CHOICE Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by PRO TRAINERS' CHOICE Co filed Critical PRO TRAINERS' CHOICE Co
Priority to PCT/US2004/007523 priority Critical patent/WO2005097020A1/fr
Publication of WO2005097020A1 publication Critical patent/WO2005097020A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/05—Bandages or dressings; Absorbent pads specially adapted for use with sub-pressure or over-pressure therapy, wound drainage or wound irrigation, e.g. for use with negative-pressure wound therapy [NPWT]
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F13/00—Bandages or dressings; Absorbent pads
    • A61F13/02—Adhesive bandages or dressings
    • A61F13/0203—Adhesive bandages or dressings with fluid retention members
    • A61F13/0226—Adhesive bandages or dressings with fluid retention members characterised by the support layer

Definitions

  • lymphatic system includes lymph vessels, lymph nodes, and lymphoid tissues. Lymphatic fluid, or lymph, is collected from the interstitial spaces and is composed of fluids, organic and inorganic materials, and proteins too large for the venous system. In contrast to the closed-loop blood circulatory system, the lymphatic system works generally on a one-way flow principal. The lymph is first collected at the lymph capillaries that, in turn, drain into larger vessels.
  • the movement of the collected lymph is generally from the more distal portions of the body inwardly toward the various lymph nodes and lymphoid tissues.
  • the motive force for the lymph flow is generally associated with contractions of the adjacent muscles and walls of the larger vessels.
  • Foreign matter and bacteria are filtered at various lymph nodes, after which the fluid enters into the venous system, primarily through the thoracic duct. Approximately one to two liters of lymph fluid drain through this duct every day in a healthy individual.
  • Edema is defined as the accumulation of excess fluid in a body fluid compartment, which is generally apparent as swelling of the affected area. This fluid accumulation can occur in the cells (cellular edema), in intercellular spaces within tissues (interstitial edema), or in potential spaces or cavities within the body.
  • Edema can be caused by a variety of factors, including conditions that affect osmotic pressure, such as hypotonic fluid overload, which allows the movement of water into the intracellular space, or hypoproteinemia, which decreases the concentration of proteins and permits the passage of fluid out of the blood vessels into the tissue spaces. Edema also commonly results from surgery, injury, and other trauma or stress to the body. Vigorous exercise, for example, engaging in competitive sports, can produce stressors in the body and particularly in the joints, which result in edema or localized swelling. Other causes of edema include poor lymphatic drainage (lymphedema); conditions that cause increased capillary pressure, such as excessive retention of salt and water; heart failure; and conditions that increase capillary permeability, such as inflammation.
  • lymphatic drainage lymphatic drainage
  • capillary pressure such as excessive retention of salt and water
  • heart failure and conditions that increase capillary permeability, such as inflammation.
  • lymphedema causes pain and impede wound healing. If left untreated, fibrosis (a hardening of the tissue) may further complicate the drainage process.
  • causes of lymphedema include aplasia (lack of development) or hypoplasia (underdevelopment) of the lymphatic system; inflammatory diseases, such as bacterial infections; malignancies, where the lymphatics or lymph nodes can be blocked by tumor cells; surgical removal of various lymph nodes; radiation therapy; local trauma to a limb; and blockage of lymphatics by various parasites.
  • Various system diseases can cause lymphedema, including myxedema, renal disease (such as nephrosis or nephritis), and collagen diseases.
  • the lymphatic system is a primary system in the body for removal of the excess fluids that produce the edema or swelling.
  • a healthy lymphatic system is therefore necessary for preventing and reducing edema.
  • the body's muscle systems motivate or assist in the motivation of lymph through the body toward the lymph nodes.
  • externally applied compressive forces for example, as produced with a compressive wrap or bandage — can also assist the lymphatic system in reducing and/or preventing edema.
  • Such compressive therapies are often combined with the local application of ice or other cooling systems, which have also been found to prevent or reduce swelling. Alternatively, in some situations heating of the affected area may be beneficial to the treatment of edema.
  • Treatment modalities known in the art include compression sleeves or stockings, pneumatic compression devices, and manual lymph drainage apparatus.
  • U.S. Patents No. 5,904,145, No. 5,906,206, No. 5,916,183, No. 5,918,602, No. 6,196,231 , No. 6,254,554, and No. 6,338,723 disclose various designs for compressive sleeves and wraps for the treatment of lymphedema.
  • the devices generally include a plurality of straps used to tighten the sleeve about the limb of the patient.
  • a partially air-inflated pneumatic bladder is used to adjust the pressure applied by the straps.
  • U.S. Patents No. 5,025,781 and No. 6,315,745 disclose air inflatable/deflatable compression devices.
  • the compression device is used with a source of cyclical fluid pressure to provide alternating inflation and deflation cycles.
  • the garment disclosed in U.S. Patent No. 6,315,745 is formed through the patterned sealing of the layers of the garment at select locations to form air pockets that can selectively apply points of pressure to the affected area.
  • a therapeutic pad and system for treatment of edema wherein the therapeutic pad is secured about a portion of the user for applying a pressure that decreases generally from a relatively high pressure at the distal end to a relatively low pressure at the proximal end.
  • the therapeutic pad includes a bladder defining a flow space for a liquid, an inlet port to the bladder disposed at the distal end of the bladder, an outlet port disposed at the proximal end of the bladder, and securement for securing the therapeutic pad about a portion of the anatomy of a user.
  • the therapeutic pad system includes a pump that provides a liquid under pressure to the inlet port and receives the liquid from the outlet port, such that the liquid flows through the pad from the distal end toward the proximal end, thereby producing a pressure gradient between the distal end of the bladder and the proximal end of the bladder. This pressure gradient encourages the desired proximal flow of lymph in the user.
  • the bladder includes a plurality of seal lines that acts as flow directing blockages, the seal lines generally directing the flow of liquid through the pad in a desired direction. The seal lines may assist in dispersing liquid entering the pad through the inlet port or in directing the liquid toward the outlet port.
  • a plurality of spot welds are also provided, the spot welds holding the opposite sides of the bladder in relatively close proximity.
  • a thermal modulator such as a heat exchanger
  • the pump provides a periodic pressure pulse to the liquid such that the pressure pulse moves generally proximally through the therapeutic pad.
  • the duration of the pressure pulse may be, for example, approximately equal to the transit time of the pressure pulse through the therapeutic pad.
  • a control system controls the liquid flow rate through the therapeutic pad.
  • the control system may also control the periodicity of the pressure pulses and/or the temperature of the liquid.
  • the therapeutic pad includes a plurality of bladders, each bladder having a distal inlet port and a proximal outlet port, such that a more complicated pressure profile may be applied to the user.
  • the plurality of bladders may form a unitary pad or may be separately securable to the user.
  • the bladders may be separately engageable, and may be pressurized simultaneously, in series, or independently.
  • the therapeutic pad is adapted to be secured about a portion of the leg, knee, or shoulder of the user.
  • FIGURE 1 shows a schematic of a first embodiment of a therapeutic pad system according to the present invention
  • FIGURE 2 illustrates the therapeutic pad system of FIGURE 1 , applied to the limb of a user, and showing in general an idealized steady-state pressure profile applied by the pad to the user
  • FIGURE 3 illustrates the therapeutic pad system of FIGURE 1, applied to the limb of a user, and showing in general an idealized transient pressure profile applied to the user when a pulsed fluid pressure is applied
  • FIGURE 4 illustrates a schematic of a second embodiment of a therapeutic pad system according to the present invention
  • FIGURE 5 illustrates a general representation of a representative timing sequence of the solenoid valves for the system of FIGURE 4
  • FIGURE 6 illustrates a plan view of an embodiment of the flexible therapeutic pad for the system shown in FIG.
  • FIGURE 1 shows a schematic diagram of a first embodiment of a therapeutic pad system 50 in accordance with the present invention, and including a pad 70 having a securement system 72, for example, straps with hoops and hooks type fasteners, adapted to permit the pad 70 to be secured about a portion of the body of a user (not shown), and a bladder 74.
  • a securement system 72 for example, straps with hoops and hooks type fasteners
  • the securement system 72 preferably permits the pad 70 to be secured in such a way that a base pressure, P 0 , may be mechanically provided when the pad 70 is secured to the user.
  • An inlet port 76 to the bladder 74 is provided at a distal end of the bladder 74, and an outlet port 78 is provided at the proximal end of the bladder 74.
  • proximal and distal refer in general to the portion of the referenced element that is directed toward the "proximal” or “distal” portion, respectively, of the user when the system is in use, and wherein the lymph is understood to generally flow from a relatively distal portion of the user's anatomy to a relatively proximal portion.
  • the therapeutic pads disclosed herein are intended to be applied to the user such that the direction from the distal end of the pad to the proximal end of the pad is generally in the direction of the lymph flow in the user.
  • the bladder 74 receives a fluid through the inlet port 76. The fluid flows proximally through the bladder 74 and exits through the outlet port 78.
  • a pump 58 provides a pressure or motive force for circulating the fluid through the bladder 74.
  • a thermal modulator such as a heat exchanger 68 is provided to cool or heat the circulating fluid, whereby the therapeutic pad 70 can apply a thermal therapy simultaneously with a pressure therapy, as discussed below.
  • a control 62 communicates with the pump 58 and optionally with the heat exchanger 68 to control the timing, duration, flow rate, applied force, and temperature of the circulating fluid.
  • a power supply 52 for example, a battery system, external power source, or the like — provides power to the pump 58, control 62, and heat exchanger 68.
  • the power supply 52, pump 58, control 62, and heat exchanger 68 may be conveniently provided in a single, portable console 55 (shown schematically in FIGURE 1), that is connected to the therapeutic pad 70 with appropriate tubing 65.
  • the bulk fluid flow through the bladder 74 is generally one way — that is, from the inlet port 76 at the distal end of the bladder 74 to the outlet port 78 at the proximal end of the bladder 74.
  • pumping fluid through the bladder will produce a hydraulic pressure in the bladder 74, thereby increasing the pressure that is applied by the therapeutic pad 70 to the user.
  • the hydraulic pressure will exhibit a pressure gradient across the bladder 74 from a relatively high pressure, PH (see FIGURE 2), at the inlet port 76, to a relatively low pressure, P , at the outlet port 78.
  • the pressure gradient results naturally from the fluid flow through the bladder 74.
  • the flow of a viscous fluid is generally described by the Navier-Stokes equations of fluid mechanics.
  • the momentum flux and flow rate are proportional to the pressure gradient between the inlet and outlet ports. It is a fundamental property of a fluid that in the presence of a pressure gradient, a fluid will flow in the direction from a relatively high pressure toward a relatively low pressure.
  • the pump 58 provides a motive pressure to drive the liquid through the bladder 74. Viscous and hydrodynamic forces in the bladder 74 will hinder the liquid flow resulting in a pressure drop across the bladder 74.
  • FIGURE 2 depicts the therapeutic pad system 50 of FIGURE 1 , applied to a limb 30 of a user, and showing a steady-state, or time- and transversely-averaged pressure profile 32 along the length of the pad 70, wherein the highest pressure, P H , is at the inlet port 76, and the lowest pressure, P L , is at the outlet port 78.
  • the details of the pressure profile 32 may vary based on a number of factors but will, in general, monotonically decrease along the length of the pad 70, along the direction of the fluid flow.
  • the pad 70 therefore produces a desired pressure profile 32 applied to the user along the length of the pad 70, wherein the pressure is greater at the distal end, and less at the proximal end, thereby providing a compressive force to the user that encourages a generally proximal lymph flow.
  • the pump 58 may provide a time- varying driving pressure to the liquid — for example, to provide a periodic pressure ramp or pulse t-hrough the pad 70.
  • FIGURE 3 depicts the therapeutic pad system 50 of FIGURE 1, applied to a limb 30 of a user and showing a transversely-averaged transient pressure pulse 34A, 34B, 34C, 34D passing through the bladder 74, where the arrow indicates the temporal direction.
  • FIGURE 4 shows a schematic of another embodiment of a therapeutic pad system 100 according to the present invention.
  • a motor 106 powered by a battery 102 through switch 104 drives pump 108.
  • the inlet of the pump 108 communicates with a reservoir 120.
  • a filter (not shown) may be positioned between the reservoir 120 and the pump 108.
  • the outlet of the pump 108 communicates with either a heat exchanger 118 or the reservoir 120, depending upon the status of valves 1 14 and 1 16.
  • the valves 1 14 and 1 16 may be any suitable valve type—for example, solenoid valves are currently a preferred valve type. When solenoid valve 114 is closed and solenoid valve 1 16 is open, the outlet of the pump 108 communicates with the heat exchanger 1 18, coupling 122, check valve 124, flexible therapeutic pad 300, flow restrictor 126, and reservoir 120.
  • solenoid valve 1 14 when solenoid valve 1 14 is open and solenoid valve 1 16 is closed, the pump 108 communicates directly with reservoir 120, which bypasses the heat exchanger 1 18 and the therapeutic flexible pad 300.
  • Microprocessor 1 10 controls the opening and closing of the solenoid valves 1 14 and 1 16.
  • the flow restrictor 126 cooperatively with the pump 108, creates a back pressure, thereby causing the inner and outer layers of the therapeutic pad to balloon outward.
  • the therapeutic pad 300 contains a plurality of weld spots. During use, the back pressure causes the regions of the therapeutic pad 300 between the weld spots to balloon inwardly, toward the user's skin, as well as outwardly toward the outer, elastic binder.
  • Pump 108 is operatively connected to a motor 106.
  • the pump 108 has inlet and outlet ports (not shown) that may be substantially identical.
  • the inlet port of pump 108 may be connected by means of a short section of PVC or similar tubing to a connector elbow of the reservoir 120 outlet.
  • the outlet port of pump 108 is connected using a short section of PVC or similar tubing to a connector elbow.
  • the tubing used has an internal diameter of 3/16 inch.
  • the pump is a 24-Volt DC pump, model number UGP-2010P, manufactured by B & D Pumps. This pump is generally capable of providing up to 16 gallons per hour of liquid flow at an applied voltage of 12-volt DC.
  • the power source for the motor may be a battery or 12-volt power supply.
  • the power supply may be connected to any conventional household outlet, and is provided with the appropriate transformer.
  • FIGURE 5 shows schematically a typical timing sequence for solenoid valves 1 14 and 1 16.
  • solenoid valve 1 14 is open when solenoid valve 116 is closed, and vice versa.
  • the open time for solenoid valve 114 is designated as ti
  • the open time for solenoid valve 116 is designated as t 2 . Open times ti and t 2 are not necessarily equal.
  • solenoid valve 114 During the cycle in which solenoid valve 114 is closed and solenoid valve 1 16 is open, the fluid travels through the heat exchanger 1 18 and then through the therapeutic pad 300 from the inlet port located in the distal aspect of the affected limb to the proximal outlet port, thereby moving interstitial fluid in a distal to proximal direction. It is possible to choose the open time of solenoid valve 116 to approximate the transit time of the fluid through therapeutic pad 300.
  • the pump communicates with the bypass circuit through reservoir 120. The backward flow of fluid from therapeutic pad 300 is prevented by check valve 124.
  • the closed time of solenoid valve 1 16 (equivalent to the open time of solenoid valve 1 14) may be selected to be approximately equal to the time for the majority of fluid to flush through the therapeutic pad 300.
  • the heat exchanger 118 regulates the temperature of the inlet fluid to the therapeutic pad 300.
  • the temperature of the circulating fluid can be regulated to produce either a cooling or heating effect upon the limb being treated, or can approximate ambient temperature, whereby the fluid will produce neither a significant cooling nor heating effect upon the limb.
  • cooling can be accomplished by immersing heat exchange coils containing the circulating liquid into a mixture of ice and water (not shown).
  • the coolant system can utilize a vapor- compression refrigeration system, thermoelectric cooling, or heat pipe technology.
  • the main working parts are the evaporator, condenser, and compressor.
  • Thermoelectric cooling also called the "Peltier Effect," is a solid-state method of heat transfer through dissimilar semiconductor materials. Heat pipes passively transfer heat from the heat source to a heat sink where the heat is dissipated. Alternatively, if heat therapy is to be utilized, the circulating fluid may be heated.
  • Heating a liquid may be accomplished, for example, using any of several types of electric heaters. Some heaters physically lend themselves to direct immersion in the liquid, while others are better suited for heating a pipe or vessel containing the liquid.
  • the circulating liquid may be deionized distilled water or a mixture of deionized distilled water and a liquid, such as isopropyl or rubbing alcohol or other suitable components, to lower the freezing point of the circulating liquid when such liquid is used for cooling.
  • the concentrations by volume of the components for example, may range from 60 to 90% deionized distilled water and 40 to 10% isopropyl alcohol.
  • the presently preferred embodiment uses a mixture of about 80% deionized distilled water and about 20% isopropyl alcohol.
  • a control panel 1 12 may include any number of suitable controls.
  • the control panel 1 12 may include an on/off switch, a control for controlling the on/off timing cycles of the solenoid valves, a control for setting the temperature of the circulating liquid, and a fluid temperature display.
  • the solenoid valve timing cycles may be pre-programmed— for example, such that the adjustment dial refers to specific therapeutic pads for the lower and upper extremities.
  • the on/off times of the solenoid valves may approximate the transit time through the therapeutic pad and the time to flush the fluid through the pad when the pump communicates with the bypass circuit.
  • FIGURE 6 shows one embodiment of the therapeutic pad 300.
  • the shape of the pad 300 is rectangular in this figure, other shapes for the therapeutic pad are also contemplated, including several specific examples that are discussed below.
  • the simple, rectangular design of FIGURE 6 may be suitable for use on portions of the anatomy that do not encompass a joint. Pads that are intended to be used over a joint will typically have more complex shapes in order to permit the pad to remain in contact with the limb during movement of the joint.
  • the circulating fluid enters therapeutic pad 300 through inlet port 318 and exits through outlet port 320 disposed generally opposite the inlet port 318, whereby the flow through the pad 300 is on average one way through the pad.
  • the inlet and outlet ports may be fabricated from any suitable flexible material — for example, plastic tubing or metal fittings.
  • Therapeutic pad 300 is preferably fabricated of two superposed sheets of a flexible, waterproof material, such as polyurethane, rubber, or a synthetic form of rubber.
  • the sheets may also be fabricated from a fabric coated with an elastomer, such as polyurethane-coated nylon.
  • the sheets are joined together at the edges by suitable means, such as RF welding, heat welding, or otherwise bonded as desired. Spaced-apart heat-sealed lines 312 and spot bonds or welds 308 are also formed during the heat sealing process.
  • the spot welds typically range in diameter from 1/8 inch to 1/4 inch, with the spacing between spot welds typically varying between 1/4 inch to 1/2 inch.
  • the spot welds may be uniformly or randomly distributed throughout the therapeutic pad.
  • the therapeutic pad 300 as shown in FIGURE 6, represents one preferred embodiment of the present invention and is generally intended for an area on the limb that does not encompass a joint. Other shapes are possible and contemplated by the present invention. For example, more complex shapes intended for use on the thigh, knee, and shoulder joints are disclosed later.
  • the therapeutic pad 300 includes a bladder defining three distinct sections — an inlet manifold 302, a center section 304, and an outlet manifold 306.
  • the inlet manifold 302 is in fluid communication with the inlet port 318 and center section 304.
  • the outlet manifold 306 is in fluid communication with the center section 304 and the outlet port 320.
  • Heat seal lines 314 in inlet manifold 302 are oriented to direct the circulating fluid from inlet port 318 toward each of the spaces 310 in the center section 304 of therapeutic pad 300 formed by the heat seal lines 312.
  • Heat seal lines 316 in outlet manifold 306 are oriented to direct the circulating fluid from each of the spaces 310 in the center section 304 of therapeutic pad 300 toward outlet port 320.
  • seal lines 312 are shown as individually continuous lines, intermittent seal lines 312 are also contemplated by the present invention, and may provide in advantages such as greater flexibility, and more even transverse pressure distribution.
  • seal lines may be wider than shown, and/or may be of more complex shape, to produce the desired flow pattern.
  • the seal lines 312 and spot bonds or welds 308 form the spaces 310 that direct the circulating fluid from inlet manifold 302 to outlet manifold 306 along generally parallel paths.
  • the seal lines 312 are shown with ripples to reduce eddy currents adjacent to the lines. Spot welds 308 are distributed generally throughout the therapeutic pad 300. Without the spot welds 308, the sections between adjacent heat lines 312 will undesirably balloon out in response to the fluid pressure since the inner and outer layers of the bladder are fabricated from expandable materials.
  • FIGURE 7 shows a representative region of the space 310 between two spot welds 308 of the pad 300.
  • the inner layer 402 and the outer layer 404 of the therapeutic pad are shown expanded in response to the fluid pressure.
  • the thickness of the space 310 may range from 1/16 to 1/2 inch. In a preferred embodiment, the thickness will range from 1/8 to 3/8 inch.
  • the outer wrap 406 may be fabricated from any suitable material, preferably an elastic woven fabric. Furthermore, it some applications it may be advantageous that the outer wrap 406 be anisotropic, i.e., having a greater elongation axially than radially.
  • the present invention does not rely solely on radial compression from the outer wrap 406 to reduce the degree of edema. Rather, the present invention provides a directional pressure gradient that may be time-varying, to promote a distal to proximal lymph flow.
  • the ability of the outer wrap 406 to elongate in an axial direction provides improved form and fit when the limb is moved while the therapeutic pad is in place, particularly when the therapeutic pad spans a joint, such as the knee or elbow.
  • the outer wrap 406 may be fashioned to secure the therapeutic pad about the desired portion of the user's anatomy. It will be appreciated that the properties of the outer wrap 406 may be selected by using fabrics having the desired properties.
  • the seal lines 312 are shown to be generally parallel to each other in FIGURE 6. In the preferred embodiment, the seal lines 312 are oriented to approximately follow the direction of physiologic lymph flow when the pad 300 is in use. It should be appreciated that by locating the inlet and outlet ports 318, 320 generally at opposite ends of the pad 300, the substantially unidirectional flow in the pad 300 may be directed to flow along the user's natural lymphatic pathways, as discussed below, thereby generating a desired pressure profile that directs flow generally toward the lymphatic nodes. As shown in FIGURES 8A and 8B, a fluid return channel 522 may be incorporated into a therapeutic pad 500, 501 such that the circulating fluid may be collected near the fluid inlet port 518.
  • the inlet port 518 is disposed at the distal end of the therapeutic pad 500, and the outlet port 520 is disposed internally at the proximal end of the therapeutic pad 500, 501.
  • the fluid flow within the pad 500, 501 is still distal-to-proximal, as indicated by the arrows, producing the desired pressure profile qualitatively as shown in FIGURE 2.
  • Appropriate heat seal lines 512 and or spot welds (not shown) define flow channels within the pad 500, 501 as discussed above.
  • the inlet port may be disposed internally, with a supply line disposed internally to the pad, as long as the fluid flow through the pad is effectively distal to proximal when the pad is properly applied to the user.
  • FIGURES 9A and 9B show the general features of the therapeutic pad 700 for the upper arm and shoulder.
  • FIGURE 9A shows a palmar view of pad 700
  • FIGURE 9B shows a dorsal view of pad 700.
  • the therapeutic pad 700 includes inlet ports 704 and 722, inlet manifolds 706 and 724, upper arm sections 708 and 726, anterior shoulder flap 710, and posterior shoulder flap 728.
  • a pair of slits 740 and 742 extends from the axilla toward the shoulder in both the anterior and posterior shoulder flaps to facilitate conformity of the flaps with the shoulder and upper chest. The slits may extend further from the axilla toward the shoulders than is shown in FIGURES 9A and 9B.
  • the anterior shoulder flap 710 crosses the clavicle at approximately the midpoint and extends over the antero-lateral chest toward the axilla
  • the posterior shoulder flap 728 crosses the outer third of the clavicle and extends over the region of the scapula toward the axilla.
  • the shapes of both the anterior and posterior flaps can vary.
  • the anterior flap 710 may extend further anteriorly to encompass a greater portion of the anterior chest wall.
  • the posterior flap can extend further toward the midline, encompassing a greater portion of the scapular region.
  • the circulating fluid enters the therapeutic pad 700 through inlet ports 704 and 722.
  • the circulating fluid is introduced through two inlet ports 704 and 722 and two manifolds 706 and 724 to provide more uniform distribution of the circulating fluid over the palmar and dorsal aspects of the arm and shoulder.
  • the inlet ports 704 and 722 may be fluidly interconnected with a Y-connector (not shown) which, in turn, communicates with the fluid circuit shown in FIGURE 4.
  • the manifolds 706 and 724 distribute the circulating fluid uniformly from the inlet ports 704 and 722 to the upper arm sections 708 and 726 of the therapeutic pad 700.
  • only a single inlet port and manifold may be used, or more than two inlet ports and/or manifolds may be used.
  • the heat seal lines 718 and 736 direct the flow of the circulating fluid generally along the lymph territories of the upper arm and shoulder. It is known in human physiology that the radial and ulnar lymph trunks of the forearm largely join to form the medial lymph trunks of the upper arm, which primarily drain into the axillary nodes. Some of the radial lymph trunks join the lateral trunks of the upper arm, which drain into the supra- and sub-clavicular nodes.
  • the heat seal lines 718, 736 of the disclosed embodiment are generally arranged to be uniformly spaced and parallel to one another in the upper arm. The fluid flow over the medial aspect of the upper arm is directed toward the axilla.
  • the fluid flow over the anterior and lateral aspects of the upper arm is directed toward the sub-clavicular and supra-clavicular regions, corresponding to the pattern of lymph flow. Posteriorly, the fluid flow is largely directed toward the axilla, again corresponding to the pattern of lymph flow.
  • Spot welds 716, 734 are provided throughout the therapeutic pad. As discussed above, the heat seal lines 718, 736 and spot welds 716, 734 operate to distributed the circulating fluid from inlet ports 704 and 722 through manifolds 706 and 724 relatively uniformly through the upper arm sections 708 and 726, and through anterior shoulder flap 710 and posterior shoulder flap 728.
  • FIGURE 10 shows an embodiment of a therapeutic pad 800 for the treatment of edema affecting the thigh, specifically the right thigh, according to the present invention. The general features are similar to those of FIGURE 6 and will not be reiterated in detail here. Lymph drainage from the anterior thigh drains generally into the inguinal nodes.
  • Lymph drainage from the medial and lateral thigh converges toward the anterior thigh and also drains into the inguinal nodes.
  • the inlet port 818 of pad 800 is located such that in use it is on the distal aspect of the thigh, and the outlet port 820 is located proximally.
  • the inlet manifold 802 is designed to distribute the flow throughout the center section 804 of the pad 800.
  • Seal lines 814 are provided in the inlet manifold 802 to distribute the inlet flow, and seal lines 816 in the outlet manifold 806 direct the flow toward the outlet port 820.
  • Seal lines 812 and spot bonds 808 similarly define flow channels 810 in the center section 804 of the therapeutic pad 800.
  • the therapeutic pad 800 is designed to direct the flow of circulating fluid toward the inguinal nodes.
  • the outlet port 820 is off center, since the flow of circulating fluid is directed toward the medial aspect of the affected thigh.
  • the therapeutic pad 800 shown in FIGURE 10, may be applied to the treatment of edema affecting the right thigh.
  • the pad 800 may be constructed such that the pad 800 can be turned over and used to treat the left thigh — for example, by using a bladder portion of the pad that is detachable from the outer wrap.
  • FIGURE 11 shows an embodiment of a therapeutic pad 900 according to the present invention that is intended to treat edema affecting the knee, and extend to portions of the user's calf and thigh (not shown).
  • the pad 900 includes an inner bladder 920 and an outer wrap 916 attached to the bladder 920.
  • the configuration as shown in FIGURE 1 1 is intended to be used on the user's right knee. However, it will be readily appreciated that the pad 900 may be designed such that the bladder 920 can be turned over, to allow the same pad 900 to be used for the left knee.
  • the inlet manifold 902 includes seal lines 924 that generally disperse or distribute flow entering the pad 900 through the inlet port 928. In the distal center section 904 and the proximal center section 908, the seal lines 914, 922 are positioned to generally direct the flow parallel to the flow paths of lymph fluid in the portion of the user's calf and thigh that is covered or wrapped by the pad 900.
  • Oppositely-disposed tapered slits 918 and 934 are provided on both sides of cut-out 932 to allow the pad to remain in proximate contact to the skin as the knee joint is moved from flexion to extension, and vice versa.
  • the taper helps to direct the circulating fluid toward the inner aspect of the pad as it flows from the calf toward the patella, and then distributing the fluid along the various flow paths over that portion of the therapeutic pad covering the thigh.
  • single pads have been disclosed for the treatment of edema affecting a specific area of the body. It is also contemplated that two or more pads may be placed in series, such that the pads can be activated in any desired sequence, simultaneously, continuously, and or in overlapping sequence.
  • FIGURE 12 shows a schematic of one possible configuration of the present invention utilizing multiple pads arranged in series.
  • a pair of pads 300, 300' is shown in two generally separate but overlapping fluid circuits.
  • the present invention may include more than two pads.
  • the two fluid circuits share a heat exchanger 118', power supply 102', and control system 1 10'.
  • a single motor and/or pump may be used, particularly if the pads 300, 300' are to receive flow sequentially, rather than simultaneously, or if a reduced flow is desired for simultaneous operation.
  • the control system 1 10' controls the valves 1 14, 1 14', 1 16, 116', and motors 106, 106' to achieve the desired flow pattern through the pads 300, 300'.
  • FIGURE 13 depicts a system utilizing three pads 300, 300', and 300", shown wrapped about a user's leg 30, wherein pad 300 is placed distally about the user's calf 32, pad 300' is placed generally about the user's knee 34 and pad 300" is place proximally about the user's lower thigh 36.
  • a pressure profile 80 shows an idealized steady state, transversely averaged pressure profile for each of the three pads.
  • the therapeutic pads 300, 300', and 300" may be pressurized sequentially, to provide a transient pressure pulse that travels generally up the user's limb.
  • it may be preferably to pressurize the pads one at a time — for example, pressurizing the most proximal pad 300" for a period of time, to reduce the proximal swelling, then to pressurize the middle pad 300' for a period to reduce swelling in the middle region, and finally to pressurize the most distal pad 300 for a period.
  • pressurization of the individual pads may include pulsing the flow through the pad to produce a transient pressure pulse, as discussed above.
  • the sequencing and operation of the pads 300, 300', 300" is controlled by the control system 1 10", and may provide any or all of the described modalities.
  • the multiple pads 300, 300', and 300" may be constructed either as physically separate pads as shown schematically in FIGURE 12, providing greater flexibility, for example by permitting the pads to be spaced apart or overlapped.
  • the multiple pads may be made as a unitary assembly having multiple fluid flow compartments with individual inlet ports and outlet ports as indicated in FIGURE 13, such that a single assembly is wrapped about the user.
  • the unitary assembly construction would be easier to apply, and provide a predetermined relative positioning of the multiple pads. While the preferred embodiment of the invention has been illustrated and described, it will be appreciated that various changes can be made therein without departing from the spirit and scope of the invention.

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  • Health & Medical Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Thermotherapy And Cooling Therapy Devices (AREA)

Abstract

La présente invention a trait à une compresse (300) et un système (100) thérapeutique pour le traitement d'oedème, dans lequel la pression appliquée à l'utilisateur par la compresse favorise l'écoulement proximal de lymphe. Un liquide est alimenté à une ou des vessies (74) dans la compresse à travers un orifice d'entrée (76) à une extrémité distale de la compresse, et est évacuée de la vessie par un orifice de sortie (78) à l'extrémité proximale de la compresse, produisant ainsi un gradient de pression sur toute la largeur de la compresse. La pression du liquide peut être soumise à une impulsion périodique, de sorte qu'une pression pulsée traverse la compresse en une direction proximale. Une pluralité de vessies peut être utilisée pour réaliser le traitement à la pression souhaitée. Un modulateur thermique tel qu'un échangeur thermique (118) peut être prévu pour assurer un traitement thermique simultanée.
PCT/US2004/007523 2004-03-11 2004-03-11 Dispositif et procede pour le traitement d'oedeme Ceased WO2005097020A1 (fr)

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Application Number Priority Date Filing Date Title
PCT/US2004/007523 WO2005097020A1 (fr) 2004-03-11 2004-03-11 Dispositif et procede pour le traitement d'oedeme

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PCT/US2004/007523 WO2005097020A1 (fr) 2004-03-11 2004-03-11 Dispositif et procede pour le traitement d'oedeme

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Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014005170A1 (fr) * 2012-07-06 2014-01-09 Chezleon Pty Limited Dispositif thérapeutique de support destiné à être porté par un sujet
US20200188054A1 (en) * 2017-06-15 2020-06-18 Avent, Inc. Device to Reduce Steam Pops and Increase Tissue Stability During Radiofrequency Ablation

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4338944A (en) * 1980-06-16 1982-07-13 The Kendall Company Therapeutic device
US5411541A (en) * 1993-08-05 1995-05-02 Oansh Designs Ltd. Portable fluid therapy device

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4338944A (en) * 1980-06-16 1982-07-13 The Kendall Company Therapeutic device
US5411541A (en) * 1993-08-05 1995-05-02 Oansh Designs Ltd. Portable fluid therapy device

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2014005170A1 (fr) * 2012-07-06 2014-01-09 Chezleon Pty Limited Dispositif thérapeutique de support destiné à être porté par un sujet
AU2012324014B2 (en) * 2012-07-06 2016-01-21 Chezleon Pty Limited Therapeutic support for being worn by a subject
US10918556B2 (en) 2012-07-06 2021-02-16 Chezleon Pty Limited Therapeutic support for being worn by a subject
US20200188054A1 (en) * 2017-06-15 2020-06-18 Avent, Inc. Device to Reduce Steam Pops and Increase Tissue Stability During Radiofrequency Ablation
US12029617B2 (en) * 2017-06-15 2024-07-09 Avent, Inc. Device to reduce steam pops and increase tissue stability during radiofrequency ablation

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