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EP0992230A2 - Medizinische Pumpenvorrichtung und zugehörigem Verfahren - Google Patents

Medizinische Pumpenvorrichtung und zugehörigem Verfahren Download PDF

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Publication number
EP0992230A2
EP0992230A2 EP99307963A EP99307963A EP0992230A2 EP 0992230 A2 EP0992230 A2 EP 0992230A2 EP 99307963 A EP99307963 A EP 99307963A EP 99307963 A EP99307963 A EP 99307963A EP 0992230 A2 EP0992230 A2 EP 0992230A2
Authority
EP
European Patent Office
Prior art keywords
fluid
reservoir
outlet
pressure
medical
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.)
Withdrawn
Application number
EP99307963A
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English (en)
French (fr)
Other versions
EP0992230A3 (de
Inventor
designation of the inventor has not yet been filed The
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.)
KCI Licensing Inc
Original Assignee
KCI Licensing Inc
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 KCI Licensing Inc filed Critical KCI Licensing Inc
Publication of EP0992230A2 publication Critical patent/EP0992230A2/de
Publication of EP0992230A3 publication Critical patent/EP0992230A3/de
Withdrawn legal-status Critical Current

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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

Definitions

  • the present invention relates to medical pumping apparatus. More particularly, the invention relates to medical pumping apparatus for use in supplying a compressive fluid a therapeutic wrap.
  • the auxiliary compressor unit comprises a fluid reservoir, filled with gas by an associated compressor, and a mechanism for controlling the delivery of pressurized gas from the fluid reservoir to the device, which typically comprises some sort of foot wrap or the like.
  • wraps are generally well known in the relevant arts, an exemplary wrap being commercially available from Kinetic Concepts, Inc. of San Antonio, Texas under the trade designation "PLEXIPULSE.”
  • the associated compressor is either continuously ran or is ran until sonic predetermined pressure (often near the maximum pressure achievable, as will be better understood further herein) is reached in the reservoir.
  • the compressor "dead-heads," i.e. continues to operate without effect on reservoir pressure, and in the latter case the compressor is shut off for only that time beyond which the reservoir is pumped to the predetermined pressure.
  • pressurized gas delivered from the reservoir to the foot (or other) wrap is generally controlled in one of two timing-based methods.
  • first control method generally known as same-cycle adjustment
  • a valve interposed in a fluid communication line between the reservoir and the wrap is opened to allow inflation of the wrap.
  • the pressure in the wrap is monitored while the valve is open to ensure that the wrap's internal pressure does not exceed some target pressure.
  • the valve Upon reaching the not to exceed pressure, the valve is closed. This operation is then repeated for each cycle of pressure application.
  • next-cycle adjustment the valve to the wrap is opened for some determinable time period after which the valve is again closed.
  • the pressure in The wrap is then measured. Based upon this measurement, the time period for which the valve is set to remain open is adjusted for subsequent cycles, i.e. the time period is enlarged if the measured pressure is less than desired and the time period is reduced if the measured pressure is greater than desired. Again, this operation is repeated for each cycle of pressure application.
  • the present invention for use with a therapeutic patient treatment system - generally comprises a reservoir for holding a compressed fluid, with a fluid outlet and a valve for controlling flow of fluid from the reservoir through the outlet; a compressor for supplying pressurized fluid to the reservoir; and a controller for controlling the supply of pressurized fluid to the reservoir and for controlling the flow of fluid from the reservoir through the outlet.
  • the controller has associated wherewith a sensor for measuring the internal pressure of the reservoir, and is adapted to provide the reservoir with an initial quantity of fluid on an initial cycle of operation; to operate the valve to release the initial quantity of fluid from the reservoir through the valve; to measure the internal pressure of the reservoir while the valve is operated; and to provide the reservoir with an additional quantity of fluid, less than the initial quantity of fluid based upon a comparison of the internal pressure of the reservoir, alter the release of the initial quantity of fluid, with a target pressure.
  • a sensor for measuring the internal pressure of the reservoir and is adapted to provide the reservoir with an initial quantity of fluid on an initial cycle of operation; to operate the valve to release the initial quantity of fluid from the reservoir through the valve; to measure the internal pressure of the reservoir while the valve is operated; and to provide the reservoir with an additional quantity of fluid, less than the initial quantity of fluid based upon a comparison of the internal pressure of the reservoir, alter the release of the initial quantity of fluid, with a target pressure.
  • the medical pumping system comprises a plurality of fluid outlets, wherein each fluid outlet has associated respectively therewith a valve for controlling flow of fluid from the reservoir therethrough. Further still, the controller may be adapted to release fluid from the reservoir alternately through each of the fluid outlets.
  • the valve comprises a solenoid operated valve.
  • the valve may have a vent, the vent preferably being adapted to release the pressure downstream the reservoir to the atmosphere.
  • the system may also comprise a check valve, interposed between the compressor and the reservoir, to prevent back flow of pressurised fluid from the reservoir to the compressor.
  • the sensor preferably comprises a solid state pressure transducer. Most preferably the transducer forms a component of the controller and may be integrated with the controller.
  • the medical pumping system further comprises a detector associated with the fluid outlet to provide the controller with information indicative of the connection of a medical wrap device.
  • the information may be indicative of the connection of a particular medical wrap device.
  • the detector comprises a magnetic polarity sensor.
  • the controller further comprises a pressure feedback system, whereby the controller is adapted to determine the proper connection of a medical wrap device based upon the internal reservoir pressure following a release of fluid from the reservoir through the outlet. Either embodiment, or their substantial equivalent, may be utilised to monitor patient compliance, which, with the provision of a communications port, may be by remote interface with the pumping system.
  • pressurised fluid is preferably supplied to a medical wrap by supplying a reservoir with an initial quantity of fluid; releasing the initial quantity of fluid through an outlet, adapted for fluid communication with the medical wrap, from the reservoir; measuring the outlet pressure after releasing the fluid; and then supplying the reservoir with an additional quantity of fluid being based upon a comparison of the measured outlet pressure with a target pressure.
  • the additional quantity of fluid is estimated to produce the target pressure at the outlet after a subsequent release of fluid from the reservoir through the outlet.
  • the method of operation further comprises the step of determining the proper connection of a medical wrap device based upon a comparison of the measured outlet pressure with an expected pressure value.
  • the determining of the proper connection of a medical wrap device step may be adapted for use in determining patient compliance data.
  • the additional quantity of fluid may be a quantity less than said initial quantity of fluid.
  • the pumping unit 10 of the present invention generally comprises a compressor 11; a fluid reservoir 12 in fluid communication with one or more outlets 13, 14 through a corresponding number of valves 15, 16; and a controller 17 for controlling the pressurization of the fluid reservoir 12 and the subsequent release of fluid therefrom to the fluid outlets 13, 14.
  • the pumping unit 10 is specifically adapted to operate with one or wore medical wrap devices 18, 19, such as those shown in Figure 2.
  • Figure 2 there is depicted a right foot wrap 18 and a left foot wrap 19, each adapted to provide wound healing therapy to patients exhibiting diabetic ulcers and like wounds of the feet.
  • the depicted wraps 18, 19 are described in detail in Applicant's co-pending U.S.
  • the compressor 11, reservoir 12, valves 15, 16, 26, controller 17 and other associated components of the medical pumping unit are preferably housed in an easy to handle enclosure 20 of hardened or molded plastic, which may have a user control panel 21 mounted directly thereto.
  • the pumping unit 10 includes a single push-button ON-OFF 22 switch and a display panel 21 to indicate proper operation or an alarm condition.
  • an alarm condition may include, for example, the disconnection of a medical wrap device 18, 19 from one or more of the fluid outlets 13,14 , an opened or damaged wrap device 18, 19 or a kink in a wrap supply hose 23.
  • the pumping unit 10 of the present invention is shown to comprise a conventional compressor 11, as is well know to those of ordinary skill in the art, in fluid communication with a fluid reservoir 12.
  • the fluid reservoir 12 is simply implemented with a plastic bottle.
  • the reservoir 12 is also preferably supplied with pressurized fluid from the compressor 11 through a one-way check valve 24.
  • the controller board 17 includes a pressure sensor 25 in the form of a solid state pressure transducer.
  • the sensor 25 is in fluid communication with the reservoir 12, whereby the reservoir's internal pressure may be known to the controller board 17 at any given time.
  • the reservoir 12 is shown to be in fluid communication with at least one, but preferably two, front panel air outlets 13, 14 through a plurality of solenoid actuated valves 15, 16.
  • one outlet is designated as the left outlet 13 and the other outlet is designated as the right outlet 14.
  • one solenoid valve is designated as the left valve 15 and one other as the right valve 16.
  • a third valve - the initialization and safety valve 26 - is provided for reasons detailed further herein.
  • Each valve 15, 16, 26 comprises a vent 27, 28, 29 in addition to a pneumatic flow control valve, whereby each may be used to release pressure to atmosphere.
  • the reservoir 12 is initially filled to some predetermined pressure P 1 , whereafter the compressor 11 is shut off 30.
  • the left or right valve 15, 16 is then opened for the entire compression cycle, typically on the order of two to three seconds, allowing the reservoir pressure to equilibrate with the corresponding wrap pressure, in effect causing the properly applied wrap to exert a therapeutic force upon the desired region of a patient's body 31.
  • the resultant equilibrium pressure P eq is then measured 32 by the pressure sensor 25 and compared with the desired target pressure P targ (determined on the basis of the therapy to which the patient is to be subjected) 33 in order to determine the pressure P 2 at which the reservoir 12 should be filled for the next cycle 34, 35.
  • P 2 is set to a pressure x greater than P 1 36.
  • P eq as found to be greater than P targ
  • P 2 is set to a pressure x less than P 1 37.
  • many formulations may be contrived in order to adjust the magnitude of the difference between P 2 and P 1 ( x ) according to the magnitude of the difference between P eq and P targ .
  • a large variation between the measured equilibrium pressure P eq and the desired target pressure P targ will generally dictate a greater adjustment in pressure from P 1 to P 2 than would a lesser variation between the measured equilibrium pressure P eq and the desired target pressure P targ .
  • the implementing engineer will readily see many more sophisticated formulations that will allow the equilibrium pressure P eq to be quickly brought, and thereafter maintained, within the realm of the target pressure P targ .
  • the resulting reservoir and wrap pressures for several typical cycles of this process are depicted in the plot of Figure 5.
  • the initial reservoir pressure 38 turns out to be too low to achieve the desired wrap pressure 39.
  • the controller 17 instructs the compressor 11 to fill the reservoir 12 to a slightly higher pressure 40 for the subsequent cycle.
  • the wrap pressure 41 is found to be above the desired target pressure 39 and the controller 17 adjusts the set pressure for the reservoir 12 to a slightly less pressure 42.
  • the controller 17 instructs the compressor 11 to fill the reservoir 12 to the same pressure 42 for subsequent cycles.
  • a specific object of the present invention to provide a medical pumping unit 10 of this type that is simple to operate, thereby facilitating home care for those of most varied ability.
  • the pumping unit be of one-button 22 type operation.
  • pumping units 10 have required significant adjustment by a physician or highly trained technician in order to ensure delivery of the desired therapy. Further, it is necessary to tell the prior art devices whether to pump the right side, left side or both. As a result of this need to program a desired pumping protocol, such one-button type operation has not been previously realized.
  • FIG. 6 there is shown the setup feature of the preferred embodiment of the present invention.
  • This setup feature eliminates the need to program a desired pumping protocol, allowing the pumping unit 10 to very robustly determine which side to pump and even, if desired, what type of therapeutic function to provide.
  • the reservoir 12 is at power-up first vented 44 through the initialization and safety valve vent port 29. This ensures a known reference pressure in the reservoir 12 with respect to atmosphere. After venting, two cycles of air are blown through the right side outlet 45 (or left) without venting to atmosphere therebetween. After the second cycle, the equilibrium pressure is measured 46. If a pressure is present, a wrap is indicated and the pumping unit automatically configures to pump to the right (or left) side 47.
  • the reservoir is then vented again 48 through the initialization and safety valve vent port 29 and the process is repeated for the remaining side to wit two cycles of air are blown through the left side outlet 49 (or right) without venting to atmosphere therebetween.
  • the equilibrium pressure is measured 50. If a pressure is present, a wrap is indicated and the pumping unit automatically configures to pump to the left (or right) side 51.
  • the system is then vented a final time, after which is commenced 52 the normal pumping routine as depicted in Figure 4.
  • the preferred embodiment of the present invention is also provided with a communications interface 53, such as an RS-232 standard communication port.
  • a communications interface 53 such as an RS-232 standard communication port. This feature allows remote programming of the pumping unit 10 for such purposes as providing software upgrades.
  • the communications port 53 also allows built in test type diagnostic data to be downloaded for checkout and maintenance of the pumping unit 10. Patient compliance data, which is available through the system's ability to distinguish between a properly and improperly applied wrap, may also be monitored through the communication port 53. Finally, warning indicators, such as the need for service or physician intervention, may be automatically transmitted.
  • a sensor 54 may be inserted within the wrap's hose connector 55 in order to identify the type of wrap.
  • One such sensor could be a simple magnet, presenting either a North pole or South pole. While the detection of no magnetic field at a corresponding sensor 56 on the pumping unit would indicate the absence of any wrap, detection of a North pole might indicate a foot wrap and detection of a South pole could indicate a calf wrap.
  • the foregoing detailed description should not be construed as a limitation of the scope of the present invention, which is limited only by the claims appended hereto.

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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)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)
  • External Artificial Organs (AREA)
EP99307963A 1998-10-08 1999-10-08 Medizinische Pumpenvorrichtung und zugehörigem Verfahren Withdrawn EP0992230A3 (de)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
US16859798A 1998-10-08 1998-10-08
US168597 1998-10-08

Publications (2)

Publication Number Publication Date
EP0992230A2 true EP0992230A2 (de) 2000-04-12
EP0992230A3 EP0992230A3 (de) 2001-08-22

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EP99307963A Withdrawn EP0992230A3 (de) 1998-10-08 1999-10-08 Medizinische Pumpenvorrichtung und zugehörigem Verfahren

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001097747A1 (en) * 2000-06-17 2001-12-27 Novamedix Distribution Limited Leakage detection method for a pressurised medical appliance
US7076993B2 (en) 2000-06-17 2006-07-18 Novamedix Distribution Limited Leakage detection method for a pressurised medical appliance
US7641623B2 (en) 2003-04-11 2010-01-05 Hill-Rom Services, Inc. System for compression therapy with patient support
US9737454B2 (en) 2012-03-02 2017-08-22 Hill-Rom Services, Inc. Sequential compression therapy compliance monitoring systems and methods
CN109498391A (zh) * 2018-12-12 2019-03-22 江苏美德愈医疗科技有限公司 负高压糖尿病足创面治疗装置的双向密封部
US10507158B2 (en) 2016-02-18 2019-12-17 Hill-Rom Services, Inc. Patient support apparatus having an integrated limb compression device

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3957493A (en) 1972-12-26 1976-05-18 Fuji Photo Film Co., Ltd. Thermodevelopable photographic material with N-haloacetamide
US10391098B2 (en) 2014-05-19 2019-08-27 Board Of Regents, The University Of Texas System Antisense antibacterial compounds and methods

Family Cites Families (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JP3017569B2 (ja) * 1991-05-30 2000-03-13 松下電工株式会社 エアマッサージ制御方式
CA2071379C (en) * 1991-11-12 1998-11-10 John F. Dye Compression device
US5769801A (en) * 1993-06-11 1998-06-23 Ndm Acquisition Corp. Medical pumping apparatus
US5443440A (en) * 1993-06-11 1995-08-22 Ndm Acquisition Corp. Medical pumping apparatus
US5840049A (en) * 1995-09-07 1998-11-24 Kinetic Concepts, Inc. Medical pumping apparatus
US5843007A (en) * 1996-04-29 1998-12-01 Mcewen; James Allen Apparatus and method for periodically applying a pressure waveform to a limb

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US3957493A (en) 1972-12-26 1976-05-18 Fuji Photo Film Co., Ltd. Thermodevelopable photographic material with N-haloacetamide
US10391098B2 (en) 2014-05-19 2019-08-27 Board Of Regents, The University Of Texas System Antisense antibacterial compounds and methods

Cited By (10)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001097747A1 (en) * 2000-06-17 2001-12-27 Novamedix Distribution Limited Leakage detection method for a pressurised medical appliance
US7076993B2 (en) 2000-06-17 2006-07-18 Novamedix Distribution Limited Leakage detection method for a pressurised medical appliance
US7641623B2 (en) 2003-04-11 2010-01-05 Hill-Rom Services, Inc. System for compression therapy with patient support
US9220655B2 (en) 2003-04-11 2015-12-29 Hill-Rom Services, Inc. System for compression therapy
US9737454B2 (en) 2012-03-02 2017-08-22 Hill-Rom Services, Inc. Sequential compression therapy compliance monitoring systems and methods
US10943678B2 (en) 2012-03-02 2021-03-09 Hill-Rom Services, Inc. Sequential compression therapy compliance monitoring systems and methods
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
CN109498391A (zh) * 2018-12-12 2019-03-22 江苏美德愈医疗科技有限公司 负高压糖尿病足创面治疗装置的双向密封部
CN109498391B (zh) * 2018-12-12 2023-09-08 江苏美德愈医疗科技有限公司 负高压糖尿病足创面治疗装置的双向密封部

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