WO2008130689A1 - Dispositif et procédé de traitement des blessures chroniques - Google Patents
Dispositif et procédé de traitement des blessures chroniques Download PDFInfo
- Publication number
- WO2008130689A1 WO2008130689A1 PCT/US2008/005117 US2008005117W WO2008130689A1 WO 2008130689 A1 WO2008130689 A1 WO 2008130689A1 US 2008005117 W US2008005117 W US 2008005117W WO 2008130689 A1 WO2008130689 A1 WO 2008130689A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- pressure
- treatment head
- wound
- irrigating
- hypobaric
- Prior art date
Links
- 206010052428 Wound Diseases 0.000 title claims description 81
- 208000027418 Wounds and injury Diseases 0.000 title claims description 80
- 238000000034 method Methods 0.000 title claims description 18
- 230000001684 chronic effect Effects 0.000 title description 5
- 239000012530 fluid Substances 0.000 claims abstract description 50
- 230000007246 mechanism Effects 0.000 claims abstract description 8
- QVGXLLKOCUKJST-UHFFFAOYSA-N atomic oxygen Chemical compound [O] QVGXLLKOCUKJST-UHFFFAOYSA-N 0.000 claims description 42
- 239000001301 oxygen Substances 0.000 claims description 42
- 229910052760 oxygen Inorganic materials 0.000 claims description 42
- 230000002262 irrigation Effects 0.000 claims description 15
- 238000003973 irrigation Methods 0.000 claims description 15
- FAPWRFPIFSIZLT-UHFFFAOYSA-M Sodium chloride Chemical compound [Na+].[Cl-] FAPWRFPIFSIZLT-UHFFFAOYSA-M 0.000 claims description 11
- 239000011780 sodium chloride Substances 0.000 claims description 11
- 238000005406 washing Methods 0.000 claims description 7
- 230000009471 action Effects 0.000 claims description 6
- 230000017531 blood circulation Effects 0.000 claims description 5
- 239000003795 chemical substances by application Substances 0.000 claims description 5
- 239000000344 soap Substances 0.000 claims description 4
- 230000000844 anti-bacterial effect Effects 0.000 claims description 3
- 230000002421 anti-septic effect Effects 0.000 claims description 2
- 230000008878 coupling Effects 0.000 claims 1
- 238000010168 coupling process Methods 0.000 claims 1
- 238000005859 coupling reaction Methods 0.000 claims 1
- 238000012163 sequencing technique Methods 0.000 claims 1
- 239000003570 air Substances 0.000 description 20
- 210000003414 extremity Anatomy 0.000 description 11
- 210000002683 foot Anatomy 0.000 description 7
- 230000035876 healing Effects 0.000 description 4
- 239000010410 layer Substances 0.000 description 4
- 239000007921 spray Substances 0.000 description 4
- 230000008901 benefit Effects 0.000 description 3
- 210000002414 leg Anatomy 0.000 description 3
- 238000002560 therapeutic procedure Methods 0.000 description 3
- 210000001519 tissue Anatomy 0.000 description 3
- 210000000689 upper leg Anatomy 0.000 description 3
- 239000012080 ambient air Substances 0.000 description 2
- 230000003115 biocidal effect Effects 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 238000007906 compression Methods 0.000 description 2
- 230000006835 compression Effects 0.000 description 2
- 206010012601 diabetes mellitus Diseases 0.000 description 2
- 238000010586 diagram Methods 0.000 description 2
- 238000005108 dry cleaning Methods 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 230000008713 feedback mechanism Effects 0.000 description 2
- 239000006260 foam Substances 0.000 description 2
- 239000007789 gas Substances 0.000 description 2
- 238000010438 heat treatment Methods 0.000 description 2
- 230000006698 induction Effects 0.000 description 2
- 238000012986 modification Methods 0.000 description 2
- 230000004048 modification Effects 0.000 description 2
- 230000017074 necrotic cell death Effects 0.000 description 2
- 210000000056 organ Anatomy 0.000 description 2
- 238000007789 sealing Methods 0.000 description 2
- 230000004936 stimulating effect Effects 0.000 description 2
- 230000000638 stimulation Effects 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- 230000000699 topical effect Effects 0.000 description 2
- 239000002699 waste material Substances 0.000 description 2
- 206010063746 Accidental death Diseases 0.000 description 1
- 200000000007 Arterial disease Diseases 0.000 description 1
- 208000034656 Contusions Diseases 0.000 description 1
- 102000004127 Cytokines Human genes 0.000 description 1
- 108090000695 Cytokines Proteins 0.000 description 1
- 206010063560 Excessive granulation tissue Diseases 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 208000025865 Ulcer Diseases 0.000 description 1
- 239000012790 adhesive layer Substances 0.000 description 1
- 210000003423 ankle Anatomy 0.000 description 1
- 230000001580 bacterial effect Effects 0.000 description 1
- 210000004204 blood vessel Anatomy 0.000 description 1
- 230000036760 body temperature Effects 0.000 description 1
- 208000034526 bruise Diseases 0.000 description 1
- 230000001276 controlling effect Effects 0.000 description 1
- 239000003814 drug Substances 0.000 description 1
- 229940079593 drug Drugs 0.000 description 1
- 239000013536 elastomeric material Substances 0.000 description 1
- 230000002538 fungal effect Effects 0.000 description 1
- 210000001126 granulation tissue Anatomy 0.000 description 1
- 239000003102 growth factor Substances 0.000 description 1
- 230000036541 health Effects 0.000 description 1
- 230000001939 inductive effect Effects 0.000 description 1
- 239000004615 ingredient Substances 0.000 description 1
- 238000011542 limb amputation Methods 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 238000007726 management method Methods 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000000203 mixture Substances 0.000 description 1
- 230000002093 peripheral effect Effects 0.000 description 1
- 239000004033 plastic Substances 0.000 description 1
- 229920003023 plastic Polymers 0.000 description 1
- 239000002985 plastic film Substances 0.000 description 1
- 229920006255 plastic film Polymers 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 230000002035 prolonged effect Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 230000001105 regulatory effect Effects 0.000 description 1
- 239000007779 soft material Substances 0.000 description 1
- 238000011301 standard therapy Methods 0.000 description 1
- 210000003371 toe Anatomy 0.000 description 1
- 231100000397 ulcer Toxicity 0.000 description 1
- 201000002282 venous insufficiency Diseases 0.000 description 1
- 230000003612 virological effect Effects 0.000 description 1
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M35/00—Devices for applying media, e.g. remedies, on the human body
- A61M35/30—Gas therapy for therapeutic treatment of the skin
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/74—Suction control
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/71—Suction drainage systems
- A61M1/77—Suction-irrigation systems
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/94—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with gas supply means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M3/00—Medical syringes, e.g. enemata; Irrigators
- A61M3/02—Enemata; Irrigators
- A61M3/0233—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs
- A61M3/0254—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped
- A61M3/0258—Enemata; Irrigators characterised by liquid supply means, e.g. from pressurised reservoirs the liquid being pumped by means of electric pumps
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/92—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing with liquid supply means
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M1/00—Suction or pumping devices for medical purposes; Devices for carrying-off, for treatment of, or for carrying-over, body-liquids; Drainage systems
- A61M1/90—Negative pressure wound therapy devices, i.e. devices for applying suction to a wound to promote healing, e.g. including a vacuum dressing
- A61M1/98—Containers specifically adapted for negative pressure wound therapy
- A61M1/982—Containers specifically adapted for negative pressure wound therapy with means for detecting level of collected exudate
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M2205/00—General characteristics of the apparatus
- A61M2205/33—Controlling, regulating or measuring
- A61M2205/3331—Pressure; Flow
- A61M2205/3334—Measuring or controlling the flow rate
Definitions
- the present invention generally relates to the field of medical treatment devices, more specifically to the field of a device and method for promoting healing and possibly preventing necrosis of human chronic wounds.
- Chronic wounds are a major health challenge especially patients with venous insufficiency, diabetes and arterial disease. Such wound can lead to limb amputation. While underlying causes of chronic wounds vary from patient to patient, they tend to occur in patients with conditions associated with poor blood circulation such as diabetes, or for other reasons related to a patient's condition.
- TNP Topical Negative Pressure therapy
- U.S. Patent No. 4,474,571 discloses a portable topical hyperbaric chamber assembly for covering a surface portion of a patient's body for treatment with pressurized oxygen.
- the assembly comprises a circular base with a plurality of support and positioning rods extending downwardly from the peripheral portion of the base.
- a resilient circular gasket open at its top and bottom, is fitted into the circular area defined by the rods depending from the base so that its top engages the bottom surface of the base for sealing purposes and the bottom engages the skin of the patient for sealing. This assembly can not adjust nor control the flow of the pressurized oxygen.
- U.S. Patent No. 4,969,881 discloses disposable hyperbaric oxygen dressing adapted to treatment of a body sore on the skin of a patient.
- a thin flexible oxygen impermeable plastic film has upper and lower surfaces.
- a rigid flat open cell plastic member is oxygen permeable.
- the member has a central opening, a flat upper surface and a flat lower surface.
- the upper member surface is sealed to the lower surface of the film, the film-member seal being oxygen impermeable.
- a first self-adhesive layer is secured to the lower surface of the member.
- a second layer of release paper is removably secured to the first layer.
- the first layer after the second layer has been removed, is adapted to be removably sealed in an oxygen impermeable manner to the skin of the patient with the sore being disposed in the opening.
- An oxygen feed tube extends through the member into the central opening.
- the tube is oxygen impermeable and sealed to the member.
- the tube-member seal is also oxygen impermeable.
- U.S. Patent No. 5,478,310 discloses a disposable hyperbaric oxygen chamber including a polyethylene bag which is substantially the length of a patient's leg. The bag is placed around the entire leg and thigh with the excess bag at the top thereof being folded over the thigh in order to fit snugly thereon without compression. This configuration is intended to stimulate growth of new blood vessels, but does not use the pressurized oxygen for stimulating the wound or stimulate blood flow into the wound.
- U.S. Patent No. 6,135,116 discloses a method and apparatus for providing concurrent applications of intermittent pneumatic compression therapy and vacuum assisted closure therapy.
- the apparatus comprises a wound dressing for introduction of a negative pressure into a wound on a patient's foot and a foot wrap for application of positive, compressive forces to substantially all of the patients foot.
- a suction pump having an associated vacuum sensor and first feedback mechanism supplies negative pressure to the wound dressing.
- a source of pressurized gas having an associated pressure transducer and second feedback mechanism supplies positive force to the foot wrap.
- At least one control system is operably associated with the suction pump.
- a source of pressurized gas, capable of being vented, is provided for controlling the negative and positive applications of pressure to the patient's foot.
- an irrigating fluid such as saline and/or gentle soap and/or antibacterial, and/or any biological, chemical or a therapeutically effective agent or agents and/or dry cleaning air spray.
- an extracorporeal device for the treatment of body wounds and tubular limbs adapted to emit a predetermined sequence of hyperbaric and/or hypobaric pressure thus facilitating blood flow along the limb while facilitating measurable oxygen flow, and irrigating the wound to remove wound debris.
- an extracorporeal device for the treatment of a body wound comprising: a treatment head adapted to be secured to a patient's body in an area of the wound, the treatment head including a chamber with at least one pressure input to receive and apply to the wound a sequence of hyperbaric and hypobaric pressures, the treatment head further including an irrigating mechanism to receive an irrigating fluid and apply the irrigating fluid to the wound; the treatment head further including a drainage output; and a control system arranged to apply the sequence of hyperbaric and hypobaric pressures to the at least one input of the treatment head, to regulate the application of the irrigating fluid input to the irrigating mechanism of the treatment head and to control the drainage output to drain irrigating fluid and wound debris from the treatment head.
- an extracorporeal device for the treatment of a body wound comprising: a treatment head adapted to be secured to a patient's body in an area of the wound; a first pump having an input for being coupled to a source of oxygen enriched air and an output coupled to the treatment head; a second pump arranged to be coupled to a source of irrigation fluid and an output coupled to the treatment head; and a controller arranged to control the first pump to produce a pressure sequence applied to the treatment head, the pressure sequence including alternating hyperbaric air pressure enriched with oxygen and hypobaric air pressure, and to control the output of the second pump to selectively apply irrigation fluid to the treatment head to wash the wound.
- a method of treating a body wound comprises: securing a treatment head to an area of the wound so that the treatment head is sealed around the area of the wound; washing the wound with a fluid through the treatment head; and applying an alternating pressure sequence on the wound through the treatment head, the pressure sequence including periods of hyperbaric pressure enriched with oxygen alternating with periods of hypobaric pressure.
- FIG. 1 schematically shows a block diagram of one embodiment of the device according to the present invention
- FIG. 2 illustrates a schematic of an embodiment implementing the principles of the invention.
- FIG. 3 shows a flow diagram of a method according an embodiment of the invention.
- FIG. 4A shows a side view of an embodiment A and cross-sections of embodiments B and C of treatment heads which can be used for implementing the invention.
- FIG. 4B shows a cross-section of another embodiment of a treatment head according to the invention.
- Fig. 5 is a cross section of another embodiment of a treatment head that can be used to implement the invention.
- wound refers hereinafter to any hit or damage of tissue caused by either an internal or external factor, and includes an ulcer, cut, bruise, incision, rift, rapture, burn or the like.
- necsis refers to accidental death of cells and living tissue.
- the term 'pressure' refers hereinafter to materials forced or a flown or pushed towards or into or adjacent to an object.
- the term also refers to a flow of fluid such as air and/or oxygen and/or a saline composition which hits at least a portion of an object in such way that may cause stimulation or movement of at least a portion of that object.
- the object is tissues of a wounded organ or limb which, cause stimulation and even simulates blood flowing in that limb.
- the pressure can either be perpendicular to the limb, or have a direction of 20°-90° from the surface of the limb or organ.
- the term 'pressure sequence' refers hereinafter to more than one act of inducing pressure for a predetermined period of time.
- Each object to which the pressure sequence is applied has its own parameters selected, among other things, from duration, amplitude, frequency, temperature, time elapsing previous and/or after the pressure induction or any combination thereof. For example, for example one object may require a sequence of 2.5 seconds of 1.2 PSI induced on a limb, followed 5 seconds of a lower pressure.
- the method of the invention may be carried out by an apparatus that automatically performs the following steps, not necessarily in the order listed:
- FIG. 1 there is shown an embodiment of the invention in which a main chamber 1 is secured to a limb 5 of a body.
- a foam or air cushion (not shown) is located in the opening of the main chamber 1 and seals the area surrounding a wound on the limb 5.
- Chamber 1 is coupled to a source of fluid, for example saline or other irrigating fluid as mentioned above, under the control of a pump 3 to pump the fluid into chamber 1 to wash the wound under the automatic control of a computing device or controller 8.
- a pump 4 is then regulated by the computing device 8 to create a hyperbaric pressure in chamber 1, enriched with oxygen (O 2 ) from a pressurized source 2 of oxygen followed by a period of hypobaric pressure.
- Computing device 8 regulates air pressure in chamber 1 according to a predetermined pressure sequence of hyperbaric and hypobaric pressures as determined by a physician taking into account the particulars of the wound being treated.
- the hyperbaric pressure may be held for a period of time, for example 0.1-30 seconds, and more preferably 2-10 seconds, after which oxygen flow from source 2 is stopped and the fluid is sucked by pump 3, and pump 4 is controlled to create hypobaric or low pressure in chamber 1.
- Low pressure is maintained in the main chamber 1 for 1-600 seconds, more preferably 10-15 seconds. After a predetermined period of time, the cycle starts again, under the automatic control of the controller 8.
- the treatment head may be configured in dependence of a particular wound that is treated.
- the main chamber 1 may be located in the bottom or top of the treatment head that is provided with an appropriately positioned opening to fit around the wound.
- Fig. 4A shows three different embodiments for treatment heads. Embodiment A is for the thigh; embodiment B is for toes; and embodiment C is for the heal and/or ankle.
- Fig. 4B shows another embodiment D for the treatment head that may be used for the full foot.
- Figure 5 shows a treatment head 50 disposed for treating a wound 53 on an extremity of a person's body, such as a leg 51.
- the treatment head 50 is sealed to around wound 53 by a soft material 55, such as a foam or suitable elastomeric material.
- Treatment head 50 includes a main chamber 1 'provided with a spray head 57 that may be structured as a shower or sprinkler head to produce an irrigating pulsating spray to wash wound 53.
- the oxygen source 2 may be a commercially available, high- pressure oxygen tank, or any other device that could be used for oxygen.
- Main chamber 1 may include provision for vigorous flow from the saline pump 3 to create a whirlpool like effect or gentle flow of irrigating fluid.
- the saline in the saline pump is disposable and should be replaced with each treatment.
- the wash or irrigating fluid may serve as a vehicle for delivery of ingredients aimed to heal or disinfect the wound. Local antiseptic, antibiotic, growth factors cytokines or the like may be added to improve or accelerate the healing process or improve bacterial/fungal/ viral control.
- Fig. 2 there is shown an embodiment in greater detail for implementing the principles of the invention.
- the illustrated system includes provisions to wash a wound, apply a vacuum and remove wound debris following the wash and to stimulate a strong blood flow by applying hypobaric (lower than atmospheric) pressure, followed by an increase of oxygen at a slightly higher than atmospheric pressure, i.e. hyperbaric pressure, around the wound. All the above phases, and not necessarily in the order described, are exerted on the wound via a treatment head that is configured as discussed above, in dependence on the location and wound size.
- hypobaric lower than atmospheric
- hyperbaric pressure i.e. hyperbaric pressure
- Fig. 2 shows a treatment head 10 sealed to a wound as discussed above and arranged with three continuously working pumps Pl, P2 and P3, eight controllable valves V-I to V-8 coupled to a controller 20 to deliver washing fluid to the wound and remove wound debris, while producing a pressure sequence in the treatment head 10.
- the pressure sequence comprises hyperbaric pressure enriched with oxygen alternating with hypobaric pressure.
- Pump Pl is employed to deliver the hyperbaric pressure enriched with oxygen from an oxygen tank 22 to the treatment head 10 via valves V-I and V-4, and to deliver the hypobaric pressure by opening valves V-3, V-5 and V-6.
- Pump P2 communicates with irrigation fluid in an irrigation fluid container 24, which may be heated by a heater 26, to deliver the heated irrigation fluid to the treatment head 10 via a valve V-2.
- the heating 26 in irrigation fluid container 24 assures the saline is at body temperature of 37 0 C.
- the heating system may have a temperature sensing device (not shown) connected to the controller 20 to sense and assure the proper temperature.
- valve V-2 is closed and valve V- 7 is opened to return the irrigation fluid back to the container 24.
- Pump P3 is employed to drain the irrigation fluid and wound waste from the treatment head 10 via a three way valve V-8 to a debris collection bottle 40 via a three way valve V-8 that has one input couple to air.
- the collection bottle 40 may have a level sensor (not shown) connected to the controller 20 to alarm the operator if the fluid level is too high so that the bottle can be removed and/or replaced.
- the pumps Pl to P3 are connected by a set of tubing in a known manner for delivery of the irrigation fluid, removal of the waste from the treatment head and delivery of the pressure sequence to the treatment head 10.
- a two-pump design is also conceivable whereby pump Pl can remove the debris and create the vacuum, if an air/liquid pump is used for pump Pl.
- the pumps may be of the rotary type. Alternatively, piston pumps may be used.
- the treatment head 10 is secured to a patient's body.
- the controller 20 starts the pumps and goes through a fast system check, during which, among other things, the treatment head 10 is checked for leaks by a pressure sensor 28 between pump Pl and valve V-I and/or a vacuum sensor 30 between valves V-3 and V-5.
- Oxygen may be delivered to the treatment head 10, increasing the pressure from about 1.0 PSI to about 3 PSI and preferably up to a value of about 1.4 to 1.6 PSI.
- the flow is stopped and the controller 20 checks the reduction in pressure via the pressure manometer 28. Then a leakage test is performed for the low pressure by applying the vacuum to the treatment head and sensing the vacuum with vacuum sensor 30.
- An exemplary sequence of valve openings and closings to achieve the described operations is set forth in Table 1 below.
- the controller 20 operates the sequence of valve openings and closings, according to the required length of time for each phase in the treatment.
- the controller 20 controls the illustrated eight valves, but can be programmed to control a smaller number of valves in a different design, to achieve a similar result as the sequence in Table 1.
- Controller 20 is used to measure and control the pressure and the vacuum. Controller 20 may have built in safety algorithms that will assure the pressure will not exceed, for example, 1.4 PSI within the range of 1.01 to 3 PSI, and that the vacuum will not be below, for example, -.0.7 PSI within the range of -0.01 to -3 PSI.
- valve V-I In case an excessively high pressure is detected by pressure sensor 28 during a hyperbaric cycle, valve V-I will close and valves V-3 and V-5 will open to reduce the pressure. Alternatively, valve V-I may remain open, but valve V-6 may open to relieve the pressure. If the vacuum is greater then -0.7 PSI, valve V-3 will close, valve V-5 will open to air, valve V-I will open and Valve V-6 will open to Air. Alternatively, valve V-8 may open to air to relieve the vacuum. [0044]
- the irrigation fluid container 24 stores the irrigation fluid for the treatment that may be saline, but may also include medication as needed and decided by a treating physician's prescription.
- valves used may be solenoid operated valves and the commands to open and close the valves are controlled by the controller 20.
- valves V- 5 and V-8 are three way valves that can let air into the tubing system according to sequence in the Table 1 below; the remaining valves are one way.
- Valves 5 and 8 are three way valves; when they are open to the air they close the other opening. Further, although valve V-6 is a one-way valve, it too is coupled to air via a filter 29. It should be apparent that because the pumps Pl to P3 run continuously, it is necessary that valves V-5, V-6 and V-8 be open to air during various ones of the listed actions. For example, valve V-8 must be open to air during all portions of the cycle except during the wash and suction action, during which the pump is coupled to the treatment head via valve V-8 to draw off irrigation fluid and wound debris. And, both valve V-5 and V-6 must be open to air during the wash and suction action so as not to strain continuously running pump P3, which creates neither high nor low pressure in the treatment head during such action.
- Fig. 3 schematically illustrates the steps taken in one embodiment of the method according to the present invention.
- the first step 11 is washing the wound using a combination of saline and soap.
- the high pressure is activated.
- the high pressure is alternated with low pressure on the wound.
- the low pressure may be in the range -O.Olto -3 PSI, and is preferably -0.1 to -1.0 PSI; the high pressure may be in the range 1.01-3.0 PSI, and is preferably between 1.05- 2.0 PSI.
- the controller 20 may have an operator interface including one or more buttons, or a touch screen.
- the device may be connected to a displays or the display may be incorporated in the device.
- the display may show data on the time elapsed since the start of pressure induction, the level of pressure, or any other parameter.
- the display may be digital, and may include one or more graphs.
- the device can also be attached to at least one sensor to provide an alert in case the level of any parameter exceeds a predetermined threshold.
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- Health & Medical Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Engineering & Computer Science (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Public Health (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Pulmonology (AREA)
- Devices For Medical Bathing And Washing (AREA)
Abstract
L'invention concerne un dispositif extracorporel pour le traitement d'une blessure du corps. Le dispositif selon l'invention comprend une tête de traitement conçue pour être attachée au corps d'un patient dans la zone de la blessure. La tête de traitement comprend une chambre munie d'au moins une entrée de pression, destinée à recevoir et appliquer à la blessure une séquence de pressions hyperbares et hypobares, et un mécanisme d'irrigation destiné à recevoir un fluide d'irrigation et à appliquer le fluide d'irrigation sur la blessure. La tête de traitement comprend également une sortie de drainage. Un système de commande est prévu pour appliquer la séquence de pressions hyperbares et hypobares à la ou les entrées de la tête de traitement, pour réguler l'application du fluide d'irrigation au mécanisme d'irrigation et pour contrôler la sortie de drainage pour drainer le fluide d'irrigation et les débris de la blessure de la tête de traitement.
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US90788607P | 2007-04-20 | 2007-04-20 | |
US60/907,886 | 2007-04-20 |
Publications (1)
Publication Number | Publication Date |
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WO2008130689A1 true WO2008130689A1 (fr) | 2008-10-30 |
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PCT/US2008/005117 WO2008130689A1 (fr) | 2007-04-20 | 2008-04-21 | Dispositif et procédé de traitement des blessures chroniques |
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WO2011153261A1 (fr) * | 2010-06-01 | 2011-12-08 | Capnia, Inc. | Distributeur de gaz pour l'administration de doses précises de gaz thérapeutique à partir d'un réservoir contenant un gaz thérapeutique fortement comprimé |
CN102283771A (zh) * | 2011-07-26 | 2011-12-21 | 惠州市华阳多媒体电子有限公司 | 一种高压氧供应装置及负压伤口治疗系统 |
WO2012166428A1 (fr) * | 2011-05-27 | 2012-12-06 | Kci Licensing, Inc. | Systèmes et procédés pour distribuer un fluide à un pansement de thérapie de plaie |
US8708981B2 (en) | 2011-05-26 | 2014-04-29 | Kci Licensing, Inc. | Systems and methods of stimulation and activation of fluids for use with instillation therapy |
US8758291B2 (en) | 2009-08-07 | 2014-06-24 | Acute Ideas, Inc. | Wound ventilation system |
US8939961B2 (en) | 2007-05-31 | 2015-01-27 | Aoti, Inc. | Controller for an extremity hyperbaric device |
EP2814532A4 (fr) * | 2012-02-13 | 2015-10-14 | Integrated Healing Technologies | Appareil à multiples modes de traitement des plaies |
US9174034B2 (en) | 2007-11-06 | 2015-11-03 | Aoti, Inc. | Adaptable topical hyperbaric device |
US9211227B2 (en) | 2007-11-07 | 2015-12-15 | Aoti, Inc. | Pressure compensating seal with positive feedback |
US9907888B2 (en) | 2011-04-20 | 2018-03-06 | Kci Licensing, Inc. | System for purging negative pressure wound therapy system |
CN113925732A (zh) * | 2021-10-13 | 2022-01-14 | 陈友山 | 一种皮肤科用的创面清理装置及方法 |
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US10420699B2 (en) | 2007-05-31 | 2019-09-24 | Aoti, Inc. | Controller for an extremity hyperbaric device |
US9174034B2 (en) | 2007-11-06 | 2015-11-03 | Aoti, Inc. | Adaptable topical hyperbaric device |
US9211227B2 (en) | 2007-11-07 | 2015-12-15 | Aoti, Inc. | Pressure compensating seal with positive feedback |
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US8758291B2 (en) | 2009-08-07 | 2014-06-24 | Acute Ideas, Inc. | Wound ventilation system |
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WO2011153261A1 (fr) * | 2010-06-01 | 2011-12-08 | Capnia, Inc. | Distributeur de gaz pour l'administration de doses précises de gaz thérapeutique à partir d'un réservoir contenant un gaz thérapeutique fortement comprimé |
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US9364620B2 (en) | 2010-06-01 | 2016-06-14 | Capnia, Inc. | Gas dispenser for dispensing accurate doses of therapeutic gas from a reservoir containing highly compressed therapeutic gas |
US9907888B2 (en) | 2011-04-20 | 2018-03-06 | Kci Licensing, Inc. | System for purging negative pressure wound therapy system |
US11305046B2 (en) | 2011-04-20 | 2022-04-19 | Kcl Licensing, Inc. | System for purging negative pressure wound therapy system |
US8708981B2 (en) | 2011-05-26 | 2014-04-29 | Kci Licensing, Inc. | Systems and methods of stimulation and activation of fluids for use with instillation therapy |
US9050208B2 (en) | 2011-05-27 | 2015-06-09 | Kci Licensing, Inc. | Systems and methods for delivering fluid to a wound therapy dressing |
CN106730060B (zh) * | 2011-05-27 | 2020-12-04 | 凯希特许有限公司 | 用于向伤口治疗敷件递送流体的系统和方法 |
CN106730060A (zh) * | 2011-05-27 | 2017-05-31 | 凯希特许有限公司 | 用于向伤口治疗敷件递送流体的系统和方法 |
EP3888720A1 (fr) * | 2011-05-27 | 2021-10-06 | 3M Innovative Properties Co. | Procédés et systèmes d'administration de fluide à un pansement de plaies |
EP3299041A1 (fr) * | 2011-05-27 | 2018-03-28 | KCI Licensing, Inc. | Systèmes et procédés pour distribuer un fluide à un pansement de thérapie de plaie |
US10933177B2 (en) | 2011-05-27 | 2021-03-02 | Kci Licensing, Inc. | Systems and methods for delivering fluid to a wound therapy dressing |
WO2012166428A1 (fr) * | 2011-05-27 | 2012-12-06 | Kci Licensing, Inc. | Systèmes et procédés pour distribuer un fluide à un pansement de thérapie de plaie |
CN102283771A (zh) * | 2011-07-26 | 2011-12-21 | 惠州市华阳多媒体电子有限公司 | 一种高压氧供应装置及负压伤口治疗系统 |
EP2814532B1 (fr) | 2012-02-13 | 2017-04-05 | Integrated Healing Technologies | Appareil à multiples modes de traitement des plaies |
US10117975B2 (en) | 2012-02-13 | 2018-11-06 | Integrated Healing Technologies, LLC | Multi-modal wound treatment apparatus |
EP2814532A4 (fr) * | 2012-02-13 | 2015-10-14 | Integrated Healing Technologies | Appareil à multiples modes de traitement des plaies |
CN113925732A (zh) * | 2021-10-13 | 2022-01-14 | 陈友山 | 一种皮肤科用的创面清理装置及方法 |
CN113925732B (zh) * | 2021-10-13 | 2024-06-11 | 周美丽 | 一种皮肤科用的创面清理装置及方法 |
CN114272462A (zh) * | 2021-12-31 | 2022-04-05 | 武汉智为康来生物科技有限公司 | 一种伤口的消毒冲洗方法和装置 |
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