WO2012017417A2 - Dispositif de thermorégulation pour la thermorégulation d'un fluide organique dans des appareils médicaux - Google Patents

Dispositif de thermorégulation pour la thermorégulation d'un fluide organique dans des appareils médicaux Download PDF

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Publication number
WO2012017417A2
WO2012017417A2 PCT/IB2011/053508 IB2011053508W WO2012017417A2 WO 2012017417 A2 WO2012017417 A2 WO 2012017417A2 IB 2011053508 W IB2011053508 W IB 2011053508W WO 2012017417 A2 WO2012017417 A2 WO 2012017417A2
Authority
WO
WIPO (PCT)
Prior art keywords
thermoregulation
thermoregulator
fluid
chamber
heat exchange
Prior art date
Application number
PCT/IB2011/053508
Other languages
English (en)
Other versions
WO2012017417A3 (fr
Inventor
Daniele Galavotti
Corrado Bellini
Original Assignee
Rand S.R.L.
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 Rand S.R.L. filed Critical Rand S.R.L.
Publication of WO2012017417A2 publication Critical patent/WO2012017417A2/fr
Publication of WO2012017417A3 publication Critical patent/WO2012017417A3/fr

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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
    • A61M5/00—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests
    • A61M5/44—Devices for bringing media into the body in a subcutaneous, intra-vascular or intramuscular way; Accessories therefor, e.g. filling or cleaning devices, arm-rests having means for cooling or heating the devices or media
    • 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
    • A61M1/14—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis
    • A61M1/16—Dialysis systems; Artificial kidneys; Blood oxygenators ; Reciprocating systems for treatment of body fluids, e.g. single needle systems for hemofiltration or pheresis with membranes
    • A61M1/1698—Blood oxygenators with or without heat-exchangers
    • 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
    • A61M1/36—Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
    • A61M1/3621—Extra-corporeal blood circuits
    • A61M1/3623—Means for actively controlling temperature of blood
    • 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
    • A61M2205/12—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit
    • A61M2205/127—General characteristics of the apparatus with interchangeable cassettes forming partially or totally the fluid circuit with provisions for heating or cooling
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3606—General characteristics of the apparatus related to heating or cooling cooled
    • 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
    • A61M2205/36—General characteristics of the apparatus related to heating or cooling
    • A61M2205/3673—General characteristics of the apparatus related to heating or cooling thermo-electric, e.g. Peltier effect, thermocouples, semi-conductors

Definitions

  • thermoregulator device for fluids, in particular in medical apparatuses, which has a substantially planar body that defines, at its interior, a space for the passage of corporeal fluids.
  • Such passage is along a path configured in a manner so as to generate a tortuous and sufficiently turbulent fluid-dynamic motion in the fluids, such to exchange heat exclusively via contact with an exchange member that defines one side of the container body, eliminating the use of a thermo-conditioned fluid.
  • Disposable heat exchangers have been known for some time in the medical device field. They are used for thermally conditioning an organic fluid, typically the blood which flows in extracorporeal circuits during cardiopulmonary bypass treatments, or generally in all therapies wherein a considerable amount of patient blood during the execution of these treatments must be controlled by circulatory assistance systems, e.g. in order to compensate for the loss of heat due to the difference between the temperature of the patient, normally 37°C, and the ambient temperature, which is normally around 20 °C.
  • the prior art comprises heat exchangers which use a heated or cooled fluid for the thermal conditioning, according to treatment requirements.
  • a blood flow is made to flow in an exchanger, very often connected to an oxygenator device.
  • the exchanger is in contact with a bundle of ducts which have impermeable perimeter walls, inside of which the heated or cooled fluid (normally water) is made to flow.
  • the contact with these ducts determines the thermal conditioning of the blood, both for heating and cooling it.
  • the blood flows in a narrow path in contact with the heat-conducting surface, such that the entire blood volume assumes the temperature of the heat- conducting surface.
  • thermoregulated fluids for heating or cooling blood
  • thermoregulator devices In known thermoregulator devices, this implies construction difficulties, since suitable passage ducts of this thermoregulated fluid must be provided, along with specific chambers for heat exchange with the blood that must be thermoregulated; in the end, there are overall size problems for these thermoregulator devices.
  • a second drawback is that accidents can occur, due to which the barriers are damaged that are provided for separating the ducts in which the thermoregulated fluid flows from the exchange chamber in which the blood flows, or the ducts themselves are damaged. Such damage causes an undesired mixing, dangerous for the safety of the patient since the biological integrity of the blood to be re-sent would be irreparably compromised by the mixing with the thermoregulated fluid.
  • thermoregulated fluid A further drawback, still typical of the exchangers which employ a thermoregulated fluid, is that specific external tubes are necessary for feeding and recirculating the fluid, and these tubes, added to those in which the blood flows to/from the patient, can overall hinder the efforts of the doctors and auxiliary personnel, as they become tangled up with the equipment.
  • thermo-regulated fluid as described in US 6,045,752
  • One of such walls belongs to a non-disposable heater/cooler and is therefore designed to be hit by the blood of many patients during its use.
  • One object of the invention is to improve the state of the prior art.
  • a further object of the invention is to obtain a thermoregulator device for fluids in medical apparatuses which allows freeing the machines which use it from fixed connections for feeding and discharging a thermoregulator fluid, making them independent and transportable also for use in emergency operations outside hospitals, directly where the patient to be aided is situated.
  • thermoregulator device for fluids in medical apparatuses is provided, in accordance with claim 1 .
  • the invention therefore allows to :
  • thermoregulator device free the medical equipment that uses the thermoregulator device from fixed connections, in a manner such that it can be transported wherever an emergency operation is required;
  • thermoregulator device makes the constructive structure and the assembly of the thermoregulator device substantially simplified with respect to the state of the prior art, and therefore considerably more economical; - prevent any possible contamination of the treated fluid, being able to use completely disposable components;
  • thermoregulator device for fluids in medical apparatuses according to the invention, illustrated as a non-limiting example in the drawing set, in which:
  • FIG. 1 is a perspective and exploded view of a passage unit for an organic fluid, which is part of a thermoregulator device for thermoregulating an organic fluid in medical apparatuses, according to the invention
  • FIG. 2 is a front view of the passage unit of Figure 1 , without a heat exchange surface in order to be able to observe the interior;
  • FIG. 3 is a perspective and very schematic view of a thermoregulator unit to which the passage unit of Figure 1 is coupled;
  • FIG. 4 is a perspective view of the thermoregulator unit of Figure 3, in which thermoregulator means were removed, in order to be able to more easily observe the thermoregulation position of the passage unit;
  • FIG. 5 shows a step of coupling or uncoupling between a passage unit and a thermoregulator unit
  • FIG. 6 schematically shows a passage unit coupled to an oxygenator for oxygenating an organic fluid
  • FIG. 7 is a perspective view of the thermoregulator device according to the invention of Fig. 5, from a different observation point;
  • FIG. 8 is an exploded and perspective view of the members which constitute a thermoregulation device, with which the thermoregulator device Fig. 7 is equipped. Detailed description of a preferred embodiment
  • thermoregulator unit 20 forming a thermoregulator device for thermoregulating an organic fluid in medical apparatuses, according to the invention.
  • the passage unit 1 comprises a box-like body 2 with highly flattened form, inside of which a thermoregulation chamber 3 is defined in which a thermoregulation path is identified for the organic fluid that must be thermoregulated, indicated with the arrows "P1 " in Figure 2.
  • the path “P” starts from an entry port 4, which in the specific case is equipped with a derived opening 4' for executing the "priming” steps of the unit 1 and of the entire extracorporeal circuit connected to the latter, and finishes at an exit port 5. Both ports are obtained in the body 2 and place the thermoregulation chamber 3 in communication with the body 2 exterior
  • thermoregulation chamber 3 Inside the thermoregulation chamber 3, projecting members 6 are arranged that are designed to divert the blood flows during the passage. Such members 6 are arranged according to a pre- established geometric arrangement, creating a dense network composed of a plurality of passage channels 9 that intersect each other and divert the organic fluid in all the zones of the thermoregulation chamber 3, in order to better distribute it in contact with an inner face of a heat exchange surface 10. When the passage unit 1 is assembled, such surface 10 forms a closure wall of the thermoregulation chamber 3.
  • the heat exchange surface 10 is intended to be abutted against a sealing gasket 1 1 which is engageable on a rib 12 obtained in the body 2, and which is perimetrically projected from the thermoregulation chamber 3.
  • the heat exchange surface 10 is fixed to the body 2 by means of a frame 13 arranged for being fit under pressure in a groove 1 1 a that is perimetrically obtained between the thermoregulation chamber 3 exterior and the perimeter edge 2a of the body 2, in which the frame 13 can also be glued, hermetically closing the thermoregulation chamber 3 from the outside.
  • the heat exchange surface 10 is obtained with every known material that has high thermal conductivity properties, such as a steel plate; nevertheless, the man skilled in the art is capable of providing other materials for obtaining the heat exchange surface 10 which have the same high thermal conductivity characteristic.
  • thermoregulation chamber 3 in the thermoregulation chamber 3, a separating diaphragm 14 is provided which divides the chamber into two separate sections, i.e. an entry section "S1 " and a subsequent exit section "S2".
  • the separating diaphragm or ribbing 14 is integral or is subsequently made integral with the rib 12 and forms a single body therewith.
  • a corresponding segment 13a is designed to be inserted on the separating diaphragm or ribbing 14, such segment 13a preferably continuously derived from the gasket 1 1 .
  • a third discharge port 16 is also obtained, which is connected with the thermoregulation chamber 3 and which is intended to evacuate from such chamber possible air bubbles present in the organic fluid to be thermoregulated. Such bubbles are collected in a space 16a, in order to prevent that they are sent to the patient.
  • a connection of "luer” type is obtained, i.e. which has standardized conicity, while in figures 2, 6, 7 and 8, a version is illustrated obtained with a protected opening, with membrane member only permeable to gases and mounted at the base of the opening.
  • the body 2 also has a projecting rib 17, which is outwardly directed and arranged in order to function as a connection for coupling with an oxygenator 18, as seen in Figure 6, in a manner so as to form an oxygenation and thermoregulation group with the latter that is substantially a single piece, with reduced size with respect to the prior art.
  • the body 2 is also equipped with flexible connection members 19 that can be coupled to the thermoregulator unit 20, or uncoupled, as described below, part of the thermoregulator device according to the invention.
  • thermoregulator unit 20 comprises a hollow seat 21 , inside of which the passage unit 1 is intended to be precisely inserted, as is visible in Figures 3 and 4, in a thermoregulation configuration.
  • an autonomous thermoregulator group 22 is mounted (see Figure 3) which uses Peltier cells, which transmit heat or cold to the passage unit 1 via contact with the exchange surface 10 of the latter when it is inserted in the hollow seat 21 , in which it is retained with the engagement between the connection members 19 and a corresponding edge or tooth projecting from the hollow seat 21 (such edge or tooth provided for such purpose).
  • thermoregulator unit 20 comprises a ventilator group 55, which in an assembled configuration is associated with a box-like body 56 through which air flows of thermal conditioning flow.
  • box-like body 56 is in contact with a lateral face of a plurality of modular fin units 57, which in Figure 3 are indicated with 22 overall and which facilitate the heat exchange.
  • the box-like body 56 has an opposite face that is maintained in contact with thermo-electric members 58, typically comprising a plurality of Peltier cells 59.
  • the Peltier 59 cells are intended to be placed in contact, on the opposite side with respect to the box-like body 56, with a face of a heat/cold transfer plate 80 that is directed towards the cells, while the opposite face of this transfer plate 80 is intended to be placed in contact with the heat exchange surface 10 of the passage unit 1 in which, according to the preceding description, the organic fluid flows.
  • the hollow seat 21 is obtained in a frame 60 whose sides are respectively constituted by an open wall 60a, provided to the left with respect to the observer in order to allow the contact between the heat exchange surface 10 and the transfer plate 80, and by a box-like member 61 which has a thrust face 62 activated via a presence sensor that identifies the presence of the passage unit 1 in the hollow seat 21 .
  • a thrust face 62 activated via a presence sensor that identifies the presence of the passage unit 1 in the hollow seat 21 .
  • thermoregulator device for thermoregulating an organic fluid in medical apparatuses.
  • the fluid to be thermoregulated is drained from a patient "PT" and, through a first extracorporeal circuit section schematically and summarily indicated with 30 in Figure 6 and a pump 31 , commanded by a suitable motor, the fluid reaches the entry port 4 of the passage unit 1 , which is previously inserted in the hollow seat 21 of the thermoregulator unit 20, in a thermoregulation configuration.
  • thermoregulation chamber 3 The fluid enters into the thermoregulation chamber 3 and is spread completely therein, diverted by the projecting members 8 and following the channels 9 defined between these; it is diffused over all of the inner surfaces of the thermoregulation chamber 3.
  • the liquid follows the thermoregulation path by first flowing into the entry section "S1 " and subsequently passing through the exit section "S2", obliged by the diaphragm 14 to complete a substantially helical trajectory.
  • thermoregulator group 22 Shortly before the start of the flow of the fluid in the thermoregulation chamber 3, the thermoregulator group 22 is activated which has the plate 80 in direct contact with the exchange surface 10 of the passage unit 1 .
  • thermoregulator group 22 transmits heat or cold to the exchange surface 10 and from this, the heat or cold is transmitted, once again via contact, to the organic fluid which flows in the thermoregulation chamber 3.
  • thermoregulation path When the organic fluid has completed the thermoregulation path, it exits from the thermoregulation chamber 3 already thermoregulated, through the exit port 5. From the latter, in case of coupling for example with an oxygenator 18, it enters directly into such oxygenator in order to be subjected to an oxygenation treatment.
  • the blood is re-sent to the patient "PT" through a second return section 31 of the extracorporeal circuit.
  • thermoregulation configuration of the thermoregulator device according to the invention is obtained by inserting the passage unit 1 in the relative seat 21 provided in the thermoregulator unit 20.
  • the seat 21 is also obtained in slit form, and one side wall thereof is substantially constituted by the thermoregulator group 22, such that when the passage unit 1 is inserted, the heat exchange surface 10 results in contact with the thermoregulator group 22, receiving its heating or cooling according to the treatments to be executed on the patient "PT"; the surface 10 is thrust against such group 22 by the box-like member 61 associated with the frame 60.
  • the entire passage unit 1 i.e. the disposable heat exchanger, is extracted from the hollow seat 21 and disposed of together with the tubes, including the devices which make up the extracorporeal circuit of connection with the patient "PT".
  • thermoregulator unit 20 With regard to fixed sources of thermoregulation fluids makes medical assistance possible to patients who have urgent need, directly at the site where they are situated.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Engineering & Computer Science (AREA)
  • Anesthesiology (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Hematology (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • External Artificial Organs (AREA)
  • Endoscopes (AREA)
  • Infusion, Injection, And Reservoir Apparatuses (AREA)

Abstract

La présente invention concerne un dispositif thermorégulateur pour thermoréguler un fluide organique dans un appareil médical qui comprend une unité thermorégulatrice (20) ; une unité de passage (1) pour ledit fluide organique, agencée pour être thermorégulée par ladite unité thermorégulatrice (20) ; ladite unité thermorégulatrice (20) comprend un siège de thermorégulation (21), et ladite unité de passage (1) peut être couplée de façon amovible audit siège de thermorégulation (21) dans une configuration de thermorégulation.
PCT/IB2011/053508 2010-08-05 2011-08-05 Dispositif de thermorégulation pour la thermorégulation d'un fluide organique dans des appareils médicaux WO2012017417A2 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
ITMO2010A000231 2010-08-05
ITMO2010A000231A IT1401332B1 (it) 2010-08-05 2010-08-05 Dispositivo termoregolatore per fluidi in apparati medicali

Publications (2)

Publication Number Publication Date
WO2012017417A2 true WO2012017417A2 (fr) 2012-02-09
WO2012017417A3 WO2012017417A3 (fr) 2012-04-26

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PCT/IB2011/053508 WO2012017417A2 (fr) 2010-08-05 2011-08-05 Dispositif de thermorégulation pour la thermorégulation d'un fluide organique dans des appareils médicaux

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IT (1) IT1401332B1 (fr)
WO (1) WO2012017417A2 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015128306A1 (fr) * 2014-02-26 2015-09-03 Fresenius Medical Care Deutschland Gmbh Cassette de fluide médical et jeu de tuyaux médicaux comprenant une cassette de fluide médical
US10551330B2 (en) * 2014-04-22 2020-02-04 The Board Of Trustees Of The Leland Stanford Junior University Nanoscale optical tomography with cathodoluminescence spectroscopy
WO2021191340A1 (fr) 2020-03-27 2021-09-30 Quickcool Ab Élément d'échange de chaleur liquide amovible destiné à être utilisé dans un dispositif destiné au traitement de régulation de température
US11925738B2 (en) 2017-10-06 2024-03-12 Livanova Deutschland Gmbh Heater/cooler for an oxygenator

Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6045752A (en) 1996-03-18 2000-04-04 Medtronic, Inc. Blood oxygenator with waterless heat exchanger

Family Cites Families (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB8910966D0 (en) * 1989-05-12 1989-06-28 Du Pont Canada Panel heat exchangers formed from thermoplastic polymers
US5125069A (en) * 1989-12-22 1992-06-23 Netherlands Health Sciences Blood warmer
PT1970080E (pt) * 2005-12-15 2014-01-07 Cair Espana Sl Lab Dispositivo para ajustar a temperatura de um fluido fisiológico
EP2147690B1 (fr) * 2008-07-25 2011-11-09 WWT Technischer Gerätebau GmbH Récipient de chauffage de liquide et dispositif de chauffage de récipient

Patent Citations (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6045752A (en) 1996-03-18 2000-04-04 Medtronic, Inc. Blood oxygenator with waterless heat exchanger

Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2015128306A1 (fr) * 2014-02-26 2015-09-03 Fresenius Medical Care Deutschland Gmbh Cassette de fluide médical et jeu de tuyaux médicaux comprenant une cassette de fluide médical
US10702646B2 (en) 2014-02-26 2020-07-07 Presenius Medical Care Deutschland Gmbh Medical fluid cassette and medical hose set with a medical fluid cassette
US10551330B2 (en) * 2014-04-22 2020-02-04 The Board Of Trustees Of The Leland Stanford Junior University Nanoscale optical tomography with cathodoluminescence spectroscopy
US11925738B2 (en) 2017-10-06 2024-03-12 Livanova Deutschland Gmbh Heater/cooler for an oxygenator
WO2021191340A1 (fr) 2020-03-27 2021-09-30 Quickcool Ab Élément d'échange de chaleur liquide amovible destiné à être utilisé dans un dispositif destiné au traitement de régulation de température
EP4252723A1 (fr) * 2020-03-27 2023-10-04 Quickcool AB Élément échangeur de chaleur liquide amovible destiné à être utilisé dans un dispositif de traitement de régulation de température

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Publication number Publication date
ITMO20100231A1 (it) 2012-02-06
IT1401332B1 (it) 2013-07-18
WO2012017417A3 (fr) 2012-04-26

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