WO2011070567A1 - Système thérapeutique pneumatique de stimulation de la circulation sanguine - Google Patents

Système thérapeutique pneumatique de stimulation de la circulation sanguine Download PDF

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Publication number
WO2011070567A1
WO2011070567A1 PCT/IL2010/001015 IL2010001015W WO2011070567A1 WO 2011070567 A1 WO2011070567 A1 WO 2011070567A1 IL 2010001015 W IL2010001015 W IL 2010001015W WO 2011070567 A1 WO2011070567 A1 WO 2011070567A1
Authority
WO
WIPO (PCT)
Prior art keywords
sleeve
bladder
therapeutic device
calf
fastening
Prior art date
Application number
PCT/IL2010/001015
Other languages
English (en)
Inventor
Yuval Avni
Original Assignee
Ads & B Investment Fund L.P.
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 Ads & B Investment Fund L.P. filed Critical Ads & B Investment Fund L.P.
Publication of WO2011070567A1 publication Critical patent/WO2011070567A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H9/00—Pneumatic or hydraulic massage
    • A61H9/005—Pneumatic massage
    • A61H9/0078—Pneumatic massage with intermittent or alternately inflated bladders or cuffs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/16—Physical interface with patient
    • A61H2201/1602—Physical interface with patient kind of interface, e.g. head rest, knee support or lumbar support
    • A61H2201/165—Wearable interfaces
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5023—Interfaces to the user
    • A61H2201/5035—Several programs selectable
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2201/00—Characteristics of apparatus not provided for in the preceding codes
    • A61H2201/50—Control means thereof
    • A61H2201/5058—Sensors or detectors
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2205/00—Devices for specific parts of the body
    • A61H2205/10—Leg
    • A61H2205/106—Leg for the lower legs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H2209/00—Devices for avoiding blood stagnation, e.g. Deep Vein Thrombosis [DVT] devices
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61H—PHYSICAL THERAPY APPARATUS, e.g. DEVICES FOR LOCATING OR STIMULATING REFLEX POINTS IN THE BODY; ARTIFICIAL RESPIRATION; MASSAGE; BATHING DEVICES FOR SPECIAL THERAPEUTIC OR HYGIENIC PURPOSES OR SPECIFIC PARTS OF THE BODY
    • A61H23/00—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms
    • A61H23/02—Percussion or vibration massage, e.g. using supersonic vibration; Suction-vibration massage; Massage with moving diaphragms with electric or magnetic drive

Definitions

  • the present invention pertains to a pneumatic therapeutic device, and specifically to a vein thrombosis preventing and/or treating pneumatic device.
  • air support patient beds have been in use for a considerable period of time.
  • air support beds have been found to provide considerable patient benefit.
  • Beds of this character have a number of significant drawbacks which, in many cases, have given hospitals, rest homes and other facilities cause for concern.
  • it is quite necessary that the air sacs remain inflated within a preset pressure range to provide sufficient patient/air sac contact for even distribution of forces to the patient such that forces against any part of the patient's body remain sufficiently low that pressure lesions are unlikely.
  • US Patent 6290662 ('662) teaches an entirely self-contained, patient-worn apparatus for deep vein thrombosis (DVT) prophylaxis, and other conditions including an inflatable/deflatable bladder disposed against an extremity such as the upper calf, foot, or hand of a patient, or within a cast.
  • An inelastic member is preferably used to fully enclose the bladder and body part, such that compressive forces are directed substantially entirely against the body part of the patient when the bladder expands, thereby conserving the power and reducing the volume of pneumatic compression required to operate the device.
  • the invention may be battery operated from a source immediately proximate to the bladder arrangement, enabling the entire device to be self-contained and, in fact, worn by the patient.
  • the reduced volume also allows the use of miniaturized components including the compressor motor and compressor.
  • the aforesaid apparatus does not comprise a disposable member embracing patient's limb. In terms of hygiene it is preferable to use disposable members in most situations.
  • inflatable bladder embraces the limb creating a non-concentrated pressure pattern. Being disposed inside the inelastic member, the inflatable bladder affects overall surface of the embraced limb.
  • the FlowMedic company manufactures devices utilizing mechanical compression to improve blood flow in the lower limbs.
  • the system tugs and releases a disposable sleeve placed around the calf muscle, thus exerting repetitive cycles of external pressure build-up on the tissue, and a subsequent release.
  • the pressure exerted depends upon the Flowmedic device tugging and shortening the strap surrounding the calf and then releasing it.
  • the pressure that can be exerted in this way is distributed over overall embraced surface of limb. Therefore, it is a long felt need is to provide a means for exerting pressure at the gastocnemius or calf surface to render compression methods for increasing blood flow more effective.
  • the device comprises:
  • At least one inflatable bladder adapted to be inflated and deflated
  • a controller adapted to vary a temporal profile of pressure provided to the bladder according to a predetermined protocol
  • a sleeve adapted to embrace a calf portion of a limb, the at least one inflatable bladder is adapted to be mechanically connected to the sleeve via attaching means;
  • the sleeve consists of at least two portions: (i) a sufficiently elastic portion; and (ii) an inelastic portion; the inelastic portion comprises the at least one inflatable bladder, and the elastic portion is adapted to be stretched as a result of the inflation of the inflatable bladder on the calf portion, such that the a pushing force is actuated on the calf portion and the blood circulation is increased in the limb.
  • PTD pneumatic therapeutic device
  • PTD pneumatic therapeutic device
  • PTD pneumatic therapeutic device
  • PTD pneumatic therapeutic device
  • PTD pneumatic therapeutic device
  • the sleeve consists of at least two portions: (i) a sufficiently elastic portion; and (ii) an inelastic portion; the inelastic portion comprises the at least one inflatable bladder, and the elastic portion is adapted to be stretched as a result of the inflation of the inflatable bladder on the calf portion, such that the a pushing force is actuated on the calf portion and the blood circulation is increased in the limb.
  • Fig. la is a schematic view of the calf DVT therapeutic device in the inflated state
  • Fig. lb is a schematic view of the calf DVT therapeutic device in the deflated state
  • Fig. 2a is a schematic diagram of a DVT therapeutic device in an active phase
  • Fig. 2b is an exploded schematic diagram of a DVT therapeutic device in an active phase
  • Fig. 2c is a schematic diagram of a DVT therapeutic device in a passive phase
  • Fig. 2d is an exploded schematic diagram of a DVT therapeutic device in a passive phase
  • Fig. 3 is a graph of the influence the pneumatic stimulation on the rate of blood circulation.
  • Fig. 4a is a schematic cross-section view the calf DVT therapeutic device according to some embodiments.
  • Fig. 4a is a schematic illustration of the calf DVT therapeutic device according to some embodiments.
  • Fig. 4b is a schematic illustration of the calf DVT therapeutic device according to some embodiments.
  • Fig. 4c is a schematic illustration of the calf DVT therapeutic device according to some embodiments.
  • Fig. 4d is a schematic illustration of the calf DVT therapeutic device according to some embodiments
  • Fig. 4e is a schematic illustration of view the calf DVT therapeutic device according to some embodiments
  • Fig. 4f is a schematic illustration of the calf DVT therapeutic device according to some embodiments.
  • Fig. 5 is a schematic of the autonomous calf DVT therapeutic device
  • bedsores also known as pressure ulcers or decubitus, hereinafter refers to lesions caused by unrelieved pressure to any part of the body, especially portions over bony or cartilaginous areas. Although completely treatable if found early, without medical attention, bedsores can become life-threatening.
  • Stage I is the most superficial, indicated by redness that does not subside after pressure is relieved. This stage is visually similar to reactive hyperemia (a technical term for excessive redness) seen in skin after prolonged application of pressure.
  • Stage I pressure ulcers can be distinguished from reactive hyperemia in two ways: a) reactive hyperemia resolves itself within 3/4 of the time pressure was applied, and b) reactive hyperemia blanches when pressure is applied, whereas a Stage 1 pressure ulcer does not.
  • the skirt may be hotter or cooler than normal, have an odd texture, or perhaps be painful to the patient. Although easy to identify on a light-skinned patient, ulcers on darker-skinned individuals may show up as shades of purple or blue in comparison to lighter skin tones.
  • Stage II is damage to the epidermis extending into, but no deeper than, the dermis.
  • the ulcer may be referred to as a blister or abrasion.
  • Stage III involves the full thickness of the skin, extending into, but not through, the subcutaneous tissue layer. This layer has a relatively poor blood supply and can be difficult to heal. At this stage, there may be undermining : that makes the wound much larger than it may seem on the surface.
  • Stage IV pressure ulcer is the deepest, extending into the muscle, tendon or even bone.
  • Unstageable pressure ulcers are covered with dead cells, or eschar and wound exudate, so the depth cannot be determined.
  • DVT Deep-venous thrombosis
  • economy class syndrome a blood clot
  • leg veins such as the femoral vein or the popliteal vein or the deep veins of the pelvis.
  • Thrombophlebitis is the more general class of pathologies of this kind. There is a significant risk of the thrombus embolizing and traveling to the lungs causing a pulmonary embolism.
  • degradably performed hereinafter refers to an action wherein two elements o the invention, such as the bladder and sleeve are seperated after fastening in such a way as to damage either or both of the elements such that at least one element is unusable.
  • a core feature of the invention is to provide a device and method for preventing and treating Deep Vein Thrombosis by providing slow peristaltic pressure pulsations to the lower limbs in order to prevent pooling of blood in the lower extremities.
  • ⁇ protocol is provided which is both effective for the aforementioned purpose, but also minimally disturbing to the patient.
  • the protocol is so designed as to enable ease of habituation by the patient, thereby enabling the patient to sleep during treatment. Patient compliance is thereby encouraged.
  • the present invention discloses a pneumatic therapeutic device (PTD) for preventing and/or treating deep vein thrombosis (DVT).
  • the device comprises the following components:
  • At least one inflatable bladder adapted to be inflated and deflated
  • a controller adapted to vary a temporal profile of pressure provided to the bladder according to a predetermined protocol
  • a sleeve adapted to embrace a calf portion of a limb, the at least one inflatable bladder is adapted to be mechanically connected to the sleeve via attaching means; and, It is within the scope of the present invention that the sleeve consists of at least two portions: (i) a sufficiently elastic portion; and (ii) an inelastic portion; the inelastic portion comprises the at least one inflatable bladder, and the elastic portion is adapted to be stretched as a result of the inflation of the inflatable bladder on the calf portion, such that the a pushing force is actuated on the calf portion and the blood circulation is increased in the limb.
  • the DVT device 16 comprises a single-use sleeve 42 embracing a human leg 40 and an inflatable bladder 44 connected to inflating device 22 (not shown) by means of pipe 26 attachable to the sleeve 42.
  • Sleeve 42 embraces an anticnemion (anterior border of tibia) of the patient's leg 40.
  • An inflated bladder 44 being attached to the sleeve 42 is periodically inflated and deflated.
  • the bladder 44 presses to a back surface of the anticnemion and stimulates blood to move upward along to a vein, and the elastic portion of the sleeve is stretched as a result of the inflation of the, such that the a pushing force is actuated on the calf portion and the blood circulation is increased in the limb.
  • embodiments of the invention disclosed herein comprise disposable sleeves and disposable bladders. It is further acknowledged that embodiments of the invention are disclosed wherein neither aforementioned sleeves nor aforementioned bladders can be attached to the target limb, but are rendered attachable by uniquely fastening to each other in a configuration providing appropriate enclosure of the device on the target limb. It is further acknowledged that the embodiments of the invention disclosed herein comprise arrangements such that the sleeve and bladder are uniquely secured to complete the system in situ.
  • the sleeve only circumscribes a portion of the target limb.
  • a unit comprising the inflatable bladder is required to complete the correct disposition of the system on the target limb.
  • Unique single use fasteners are provided to attach the aforementioned elements.
  • the fasteners and the material of the sleeve are so designed such that detachment of the bladder unit after a session results in the destruction of the sleeve, rendering the sleeve unusable a second time. This is a useful feature for the sake of hygiene.
  • Means of attachment may comprise Velcro, poppers, straps, adhesive tapes and other means.
  • the sleeve 42 consists of two portions: a sufficiently elastic portion and an inelastic portions. It will be shown below, that an elastic material bladder is inelastically attached to the elastic portion of the sleeve 42. The elastic bladder exerting the calf 40 is undoubtedly more effective therapy in comparison with any known in the art elastic bladder.
  • Figs 2a and 2b show an inflated state of the bladder, Figs 2c and 2d - deflated state.
  • the inflatable bladder is held tightly against the calf and is inflated in a manner so as to exert high pressure against the calf. Intermittent slow peristaltic pressure pulsations and compressions are provided by this device thereby providing increased blood circulation through the limbs useful in preventing Deep Vein Thrombosis.
  • the protocols for the aforementioned slow peristaltic pressure pulsations and compressions allow ease of habituation, and the device can be worn and used while the patient is walking as well as stationary and even while asleep.
  • the device of the present invention may be combined with a vibrator which may be attached an enforcing strap vibrator may provide an additional stimulation of blood circulation in a human leg.
  • Fig. 3 schematically illustrates the pneumatic stimulation of the blood circulation which increases the velocity of the blood flow up to three times.
  • points 505 and 510 of a curve 500 corresponds to a rate of blood amounts before and after the pneumatic stimulation.
  • a curve 530 shows dynamics of the blood circulation in the limb.
  • a time period 520 is a pause between stimulation cycles.
  • Figs 4a and 4b illustrate the single-use sleeve 42 in inflated and deflated state, respectively.
  • Figs 4a and 4b illustrate an assembly in inflated and deflated state, respectively.
  • Figs 4a-h a specific embodiment of the present invention is shown.
  • the single-use sleeve 42 is shown in open ended manner before use (Fig. 4c), in close ended manner (Fig. 4a-b), and with torn fabric hook-and-loop fastener 82 (Fig. 4f).
  • the sleeve 42 is furnished with a tearable fabric hook-and-loop fastener 82 releasably attached to sleeve 42 by means of an adhesive layer 80.
  • the fastener 82 fixates the sleeve 42 on the leg 40.
  • a force necessary for opening the sleeve 42 after use is greater than a force needed to embracing the leg 40.
  • the inflating device 22 is autonomous and is attached to the bladder 44. Attaching the bladder 44 to the sleeve 42 is provided by grip pawls 90 attached to the bladder and mortises 92 disposed on the sleeve 42. The grip pawls 90 fit into the mortises 92 and secure the bladder 44 to the sleeve 42.
  • the sleeve 42 additionally comprises an elastic area 94 enabling more effective impact of the bladder 44 on the leg 40.
  • the aforementioned controller is adapted to vary the pressure profile in a preprogrammed manner in accordance with sensor signals such that the therapeutic system prevents and/or treats bedsores and stimulates patient's blood cycling, according to a preprogrammed and effective therapeutic regime.
  • the method further comprises attaching a plurality of the bladders to the hospital bed; placing a patient onto the bladders; inflating and deflating the plurality of the bladders by the inflating means in accordance with a preprogrammed temporal pressure profile for effective period of time; moving said patient off said bladders; further wherein the inflating and deflating of the bladders are varied according to patient's body load applied to the bladders.

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  • Health & Medical Sciences (AREA)
  • Epidemiology (AREA)
  • Pain & Pain Management (AREA)
  • Physical Education & Sports Medicine (AREA)
  • Rehabilitation Therapy (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Massaging Devices (AREA)

Abstract

La présente invention porte sur un dispositif thérapeutique pneumatique (PTD) destiné à prévenir et/ou traiter une thrombose veineuse profonde (TVP). Le dispositif comprend : au moins une vessie gonflable conçue pour être gonflée et dégonflée, un dispositif de commande, et un manchon conçu pour embrasser une demi-partie d'un membre, la vessie gonflable étant conçue pour être mécaniquement reliée au manchon par des moyens de fixation. Le manchon est composé d'au moins deux parties : (i) une partie suffisamment élastique et (ii) une partie non élastique.
PCT/IL2010/001015 2009-12-08 2010-12-02 Système thérapeutique pneumatique de stimulation de la circulation sanguine WO2011070567A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US26744809P 2009-12-08 2009-12-08
US61/267,448 2009-12-08

Publications (1)

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WO2011070567A1 true WO2011070567A1 (fr) 2011-06-16

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103845197A (zh) * 2012-12-07 2014-06-11 陈汝霖 一种便置式神经调节装置
US10507158B2 (en) 2016-02-18 2019-12-17 Hill-Rom Services, Inc. Patient support apparatus having an integrated limb compression device
US11638675B2 (en) 2018-11-07 2023-05-02 Zenith Technical Innovations, Llc System and method for heat or cold therapy and compression therapy

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010000262A1 (en) * 1998-08-12 2001-04-12 Mcewen James A. Apparatus and method for applying an adaptable pressure waveform to a limb
US20040039317A1 (en) * 2002-08-23 2004-02-26 Souney Sean J. Separable compression sleeve with barrier protection device and reusable coupler
US20060020236A1 (en) * 2004-07-21 2006-01-26 Asher Ben-Nun Disposable compression sleeve
US20080306420A1 (en) * 2007-06-08 2008-12-11 Tyco Healthcare Group Lp Compression device with independently moveable inflatable member
US20090299239A1 (en) * 2005-09-23 2009-12-03 Walter Meyer Apparatus for Preventing Deep Vein Thrombosis

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20010000262A1 (en) * 1998-08-12 2001-04-12 Mcewen James A. Apparatus and method for applying an adaptable pressure waveform to a limb
US20040039317A1 (en) * 2002-08-23 2004-02-26 Souney Sean J. Separable compression sleeve with barrier protection device and reusable coupler
US20060020236A1 (en) * 2004-07-21 2006-01-26 Asher Ben-Nun Disposable compression sleeve
US20090299239A1 (en) * 2005-09-23 2009-12-03 Walter Meyer Apparatus for Preventing Deep Vein Thrombosis
US20080306420A1 (en) * 2007-06-08 2008-12-11 Tyco Healthcare Group Lp Compression device with independently moveable inflatable member

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN103845197A (zh) * 2012-12-07 2014-06-11 陈汝霖 一种便置式神经调节装置
US10507158B2 (en) 2016-02-18 2019-12-17 Hill-Rom Services, Inc. Patient support apparatus having an integrated limb compression device
US10952920B2 (en) 2016-02-18 2021-03-23 Hill-Rom Services, Inc. Patient support apparatus having an integrated limb compression device
US11638675B2 (en) 2018-11-07 2023-05-02 Zenith Technical Innovations, Llc System and method for heat or cold therapy and compression therapy

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