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WO2015086570A1 - Appareil médical pour le traitement thermique de patients - Google Patents

Appareil médical pour le traitement thermique de patients Download PDF

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Publication number
WO2015086570A1
WO2015086570A1 PCT/EP2014/076993 EP2014076993W WO2015086570A1 WO 2015086570 A1 WO2015086570 A1 WO 2015086570A1 EP 2014076993 W EP2014076993 W EP 2014076993W WO 2015086570 A1 WO2015086570 A1 WO 2015086570A1
Authority
WO
WIPO (PCT)
Prior art keywords
heat exchanger
tubular support
thermal medium
outer shell
support element
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Ceased
Application number
PCT/EP2014/076993
Other languages
German (de)
English (en)
Inventor
Andreas Jacobus Louis Nijsen
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.)
HIRTZ & Co KG
Original Assignee
HIRTZ & Co KG
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 HIRTZ & Co KG filed Critical HIRTZ & Co KG
Publication of WO2015086570A1 publication Critical patent/WO2015086570A1/fr
Anticipated expiration legal-status Critical
Ceased legal-status Critical Current

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F7/12—Devices for heating or cooling internal body cavities
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0054—Heating or cooling appliances for medical or therapeutic treatment of the human body with a closed fluid circuit, e.g. hot water
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F7/00—Heating or cooling appliances for medical or therapeutic treatment of the human body
    • A61F2007/0091—Heating or cooling appliances for medical or therapeutic treatment of the human body inflatable
    • 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
    • A61M25/00—Catheters; Hollow probes
    • A61M25/10—Balloon catheters
    • A61M25/1002—Balloon catheters characterised by balloon shape
    • A61M2025/1004—Balloons with folds, e.g. folded or multifolded

Definitions

  • the invention relates to a medical device for thermal treatment of patients, which has a heat exchanger insertable into the body of a patient with an inner tubular support member and an outer shell surrounding this, which can be expanded under the action of a thermal medium and with a supply line and a drain is provided for the thermal medium.
  • a medical device for thermal treatment of patients which has a heat exchanger insertable into the body of a patient with an inner tubular support member and an outer shell surrounding this, which can be expanded under the action of a thermal medium and with a supply line and a drain is provided for the thermal medium.
  • Such devices serve to adjust the body temperature of the patient by heat transfer occurring within the body of the patient.
  • the heat exchanger can be placed in suitable body openings and cavities. This may, for example, be the esophagus without the applicability of the invention being limited thereto. Thus, the placement of the heat exchanger, for example, in the rectum or other body orifices or cavities possible.
  • US 2004/0210281 A1 discloses a heat exchanger insertable into the esophagus, the outer shell of which, which is in contact with the surface of the esophagus for the purpose of heat transfer, is designed as a balloon which under the pressure of the heat exchanger in the heat exchanger. expanded to the wall of the esophagus.
  • the invention is based on the object to reduce the disadvantages of known devices and thus their heat exchanger with the aim to improve the heat transfer between the hollow organ and the heat exchanger.
  • the invention proposes that the outer shell of the heat exchanger is formed as a thin tubular film, which at without noticeable elastic see deformation of the maximum expansion has a cross-section which is not smaller than the cross section of the hollow organ with therein arranged heat exchanger. This avoids that the tubular film undergoes an expansion, which would lead to an elastic stretching of its wall, which would have the disadvantageous effect described above, that the pressure exerted on the wall of the esophagus pressure would differ significantly from the effective pressure in the heat exchanger , In any case, the pressure difference caused thereby is reduced to a negligible level.
  • tubular casing it will generally be expedient to dimension the tubular casing so that it has a larger cross-section in the maximally expanded state than the hollow organ of the patient receiving the heat exchanger. This is also expedient because in many cases the receiving hollow organ has no internal diameter or open cross-section that is constant over its length.
  • the outer tube shell of the heat exchanger is not brought by an elastic expansion for abutment against the inner wall of the esophagus, but predetermined by unfolding and the maximum diameter or cross section of the shell, but not smaller, possibly larger than the smallest cross section of the hollow organ with inserted Heat exchanger corresponds, the possibility can not be excluded that the expansion process after intubation even smaller wrinkles in the flared, on the esophagus or the like outer shell are present such that at some, the outer envelope folded into a double wall is.
  • the invention provides for the use of a very thin film, the heat transfer, regardless of its direction, even in the region of a double wall only affected to a negligible extent.
  • the film may have a wall thickness of 0.03 to 0.3 mm. In the radial orientation of the fold, the impairment of the heat transfer by doubling the wall is even less significant.
  • the outer shell may be a plastic film or a metal foil.
  • the use of a composite film of suitable materials is possible.
  • the body orifices and cavities that are to be used for receiving the heat exchanger have different dimensions from one patient to another, it is expedient for practical use to dimension the outer sheath in each case in that the cross-section thereof is greater than the maximum possible cross-section of the body cavity with the heat exchanger with maximally expanded outer shell placed therein.
  • the pressure of the thermal medium should not exceed 25 mbar within the space bounded by the outer tubular shell.
  • a constant operating pressure of 20 mbar will normally lead to a sufficient heat transfer.
  • the small thickness of the wall of the outer shell favors such a pulsating treatment.
  • the outer diameter of the intubated heat exchanger in widened state depends on the particular circumstances, ie in particular also on the dimensions of the heat exchanger receiving hollow organ.
  • the diameter of the heat exchanger will normally be on the order of 14 to 17 mm.
  • the diameter or cross section of the tubular support element is also as small as possible, so that its outer diameter is for example 7 to 12 mm, preferably 8 to 10 mm.
  • the arrangement is such that the outer shell fits tightly against the support element, is suitably folded on this and / or connected to a vacuum source.
  • the heat exchanger can be made into a removable before intubating
  • Protective cover be housed, which is removed before intubating.
  • the sleeve resting against the supporting element can be externally be provided with a lubricant on the side to facilitate intubating.
  • the outer shell of the heat exchanger is widened by the thermal fluid until it rests against the inner wall of the respective body opening.
  • the direction in which the thermal fluid flows through the heat exchanger depends on whether the body temperature of the patient should be reduced or increased.
  • the distal end of the heat exchanger may extend into the patient's stomach. Since a sphincter muscle is present between the esophagus and stomach, this would mean that the outer sheath can be pressed in the region of the sphincter against the inner tubular holder made of a stronger material.
  • the thermal fluid emerging from the distal end region of the inner support tube would have to be supplied with a higher pressure in order to overcome the increased flow resistance in the area of the sphincter muscle .
  • the ability to regulate the pressure in the outer, bounded by the inner support tube and outer shell annular space would not be affected, since the pressure in the lying between the sphincter and the proximal end of the heat exchanger annulus can be measured and controlled in the desired manner.
  • the esophagus as the body cavity receiving the heat exchanger, has the advantage of being designed with predictable shapes and dimensions as an elongated body. This simplifies the insertion of the heat exchanger, but also the design and the adaptation of the shell of the same to the shapes of the esophagus. The latter is also located near the aorta, which is a fact for many treatments. is meaning.
  • FIG. 1 is a perspective view of a first embodiment of a flared heat exchanger in longitudinal section
  • Figure 2 is a perspective view of a heat exchanger in a possible output arrangement of the essential parts forming it
  • FIG. 3 shows a perspective view of the heat exchanger according to FIG. 2 in a state of the outer shell folded up to a smaller outer diameter
  • FIG. 4 shows a perspective view of the heat exchanger in a maximally expanded state
  • FIG. 5 shows a perspective view of a second embodiment of a flared heat exchanger according to the invention, partly in longitudinal section
  • FIG. 6 shows a perspective view of the heat exchanger according to FIG. 5 inserted into a gullet
  • FIG. 7 is a perspective view of a third embodiment of a flared heat exchanger
  • FIG. 8 shows a perspective view of a guidewire which can be inserted into a heat exchanger according to the invention.
  • the heat exchanger 10 shown in Figure 1 has an inner tubular support member 12 and a surrounding outer shell 14, which in the one shown in Figure 1 expanded state, a first annulus 16 bounded on the outside, which is bounded on the inside by the tubular support member 12.
  • the heat exchanger is flowed through by a thermal medium which serves to increase or reduce the body temperature of a patient.
  • a degassing tube 18 of smaller diameter is provided, which delimits a second annular space 20 on the inside, which is bounded on the outside by the inner lateral surface of the tubular support element.
  • the second annular space 20 which is bounded on the outside by the tubular support element 12 is subdivided by a web 28 carrying the degassing tube 18 into two segments 25, 26, which extend up to a connecting piece 30 attached to the distal end of the heat exchanger.
  • the thermal medium is introduced into the tubular support element at its proximal end in the first channel segment 25 of the annular space 20, from this near the distal end of the heat exchanger 10 through an opening 22 in the wall of the support element in the outside of the outer shell limited first annular space 16 to flow and then to flow through it in the direction of its proximal end 10.
  • the thermal medium flows into the second channel segment 26 of the tubular support element through a second opening 24 provided in its wall to be recirculated.
  • the degassing tube 18 is inserted at the distal end of the heat exchanger 10 with its end portion in the circular cross-section connector 30 provided with an axial passage 32 receiving the end portion of the degassing tube which is open at the distal end of the heat exchanger and thus the connection between the distal end of the degassing tube and the hollow body receiving the heat exchanger.
  • the heat exchanger is shown schematically in three states which successively result during its handling.
  • Figure 2 shows the heat exchanger after joining the essential parts forming it.
  • the outer sheath which may be made of two film sections, which are welded or glued together at their longitudinal and transverse edges 35 and 36 or connected in any other suitable manner, is also at the distal and at the proximal end of the heat exchanger 10 with the tubular support member 12 z. B. by welding or gluing tight, as Figure 1 shows.
  • the distal end of the outer shell 14 is also connected to the connecting piece 30 by means of gluing or welding or otherwise suitably.
  • the connector 30 is also sealed to the degassing tube 18.
  • the outer shell 14 is wrapped around the tubular support member 12 so that it forms close to the tubular support member 12 as shown in FIG.
  • the outer diameter or the cross section of the wound heat exchanger not much larger than the corresponding dimensions of the tubular support element.
  • the heat exchanger can be provided with a lubricant in the state in which the outer shell closely abuts the tubular support member, so as to facilitate the intubation.
  • the heat exchanger conditioned in this way can then be accommodated in a removable cover, in which it should remain until it is used on a patient to maintain the wound state and to protect an optionally applied lubricant.
  • FIGS. 5 and 6 in which with the embodiment of Figures 1 to 4 matching parts are provided with the same, but by 100 higher reference numerals.
  • the heat exchanger 110 is provided with a longer degassing tube 118 such that its distal portion 138 projects beyond the distal end of the heat exchanger 110, as shown in FIGS. 5 and 6.
  • this has the advantage that the free, open end 142 is located in the stomach, that is to say beyond the sphincter present on the stomach-side end of the esophagus, which is indicated by the arrow 140 in FIG. This has the consequence that any gases present in the stomach of the patient and possibly also
  • the free end 142 of the degassing tube 118 is provided with an external thickening 144 which is shaped to facilitate expansion of the sphincter as it passes.
  • FIG. 6 shows a special case of the arrangement of the heat exchanger 110 in the esophagus in such a way that the distal end section 146 of the heat exchanger is also located in the esophagus.
  • gene is with the result that the portion of the heat exchanger, which is located in the region of the sphincter 140, is pressed together, possibly until it rests against the inner tubular support member 112.
  • Such a positioning of the heat exchanger can not be excluded. However, it would have no negative impact on the patient.
  • the distal end portion 146 is not intended to be expanded until it abuts the stomach wall.
  • the thermal medium is guided through the tubular support member 12 and 112, respectively, into the distal end region of the heat exchanger to there in the manner already described by the first opening 22 and 122 in the wall of the tubular support member in the first of the outer shell 16 limited annulus to enter and to flow through it in the direction of the proximal end of the heat exchanger.
  • FIG. 6 of the drawing shows that the first opening 122 through which the thermal medium enters the first annulus is positioned in the section 146 of the heat exchanger located in the region of the stomach indicated by the bracket 148.
  • the substantially larger portion 150 of the heat exchanger 110 is located in the esophagus, the extension of which is indicated by the bracket 152.
  • FIGS. 5 and 6 also differs from the embodiment according to FIG. 1 in that the guidance of the thermal medium in the heat exchanger 110, in particular in its supply and discharge lines, is designed in such a way that the tubular support Mige support member 112 may have a smaller outer diameter. This is achieved in that the second annular space 120 of the tubular support element 112 is used only for the supply of the thermal medium, so that its open cross-section need not be divided.
  • the return of the medium flowing through the first annular space 116 takes place at the proximal end of the heat exchanger 110 by an additional pipe section 154 which surrounds the protruding tubular support element 112 at the proximal end of the heat exchanger 110 leaving a radial distance, so that a third annular space 156 is present which is connected at the proximal end of the heat exchanger 110 to the first annular space 116, so that the thermal medium, as indicated by the arrows 158 in Figure 5, leaving the first annulus 116 can flow into the third annular space 156.
  • the two lines for the supply and discharge of the thermal medium at the proximal end of the heat exchanger 210 are arranged side by side, wherein the supply line of the medium serving first pipe section 260 forms the proximal end portion of the tubular support member 212, with respect to the longitudinal axis and opposite the other, longer portion of the tubular support member is slightly angled.
  • the tubular support member 212 near the distal end of the heat exchanger is provided with an opening in its wall through which the thermal medium enters the first annulus 260 to flow therethrough to the proximal end of the heat exchanger and enter the second tube 262 therein , which merely forms a short section, which is provided at its distal end with an opening 264, through which the thermal medium can be derived from the first annular space 216.
  • the degassing tube 218 is optionally elastically deformable so that it can follow the non-linear course, which results from the angling of the first tube 260.
  • the tubular support element 212 can be reduced in terms of its outside diameter in relation to that of the embodiment according to FIG. 1, since it has only one channel for the supply of the medium. This reduction of a diameter of, for example
  • Knife of about 8 mm in the embodiments according to Figures 2 to 7 may be in long-term treatment of the patient of great importance.
  • FIG. 8 shows a wire section which can be introduced into the degassing tube 18 and which is adapted to the length of the degassing tube and serves to stabilize the heat exchanger during intubation.
  • the tubular support element 12 represents a compromise in terms of its flexibility, between the requirement of inherent rigidity sufficient for intubation and that of flexibility which avoids injuries to the patient during intubation.
  • the wire section allows the inherent rigidity of the heat exchanger to be adapted to the respective conditions. He will be taken out after finishing the intubation.

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  • Health & Medical Sciences (AREA)
  • Vascular Medicine (AREA)
  • Thermal Sciences (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Physics & Mathematics (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Heat-Exchange Devices With Radiators And Conduit Assemblies (AREA)
  • Prostheses (AREA)

Abstract

L'invention concerne un appareil médical pour le traitement thermique de patients, comportant un échangeur de chaleur (10) pouvant être introduit dans un organe creux du corps d'un patient, présentant un élément support (12) de forme tubulaire intérieure, et une enveloppe extérieure (14) entourant celui-ci, qui peut s'écarter sous l'effet d'un milieu thermique, et qui est pourvue d'une entrée et d'une sortie pour le milieu thermique. L'enveloppe extérieure (14), constituée de préférence par une feuille tubulaire est conçue de façon à présenter, pour un écartement maximal obtenu sans déformation élastique notable, une section qui n'est pas plus petite que la section de l'espace creux recevant l'échangeur de chaleur (10). Ceci permet d'éviter que la feuille tubulaire subisse un écartement qui entraînerait une extension élastique de sa paroi.
PCT/EP2014/076993 2013-12-09 2014-12-09 Appareil médical pour le traitement thermique de patients Ceased WO2015086570A1 (fr)

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
DE102013113706.7A DE102013113706A1 (de) 2013-12-09 2013-12-09 Medizinisches Gerät
DE102013113706.7 2013-12-09

Publications (1)

Publication Number Publication Date
WO2015086570A1 true WO2015086570A1 (fr) 2015-06-18

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/EP2014/076993 Ceased WO2015086570A1 (fr) 2013-12-09 2014-12-09 Appareil médical pour le traitement thermique de patients

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DE (1) DE102013113706A1 (fr)
WO (1) WO2015086570A1 (fr)

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002007628A2 (fr) * 2000-07-19 2002-01-31 Cryovascular Systems, Inc. Catheter de cryotherapie presentant une securite amelioree
US20040210281A1 (en) 2003-03-17 2004-10-21 Elizabeth Dzeng Transesophageal heat exchange catheter for cooling of the heart
US20060253095A1 (en) * 2002-01-16 2006-11-09 Radiant Medical, Inc. Method for gastric cooling using balloon catheter
US7144418B1 (en) * 2001-11-02 2006-12-05 Medcool, Inc. Method, and system for selective cerebral hypothermia
WO2012019156A1 (fr) * 2010-08-05 2012-02-09 Medtronic Ardian Luxembourg S.A.R.L. Appareils, systèmes et procédés de neuromodulation rénale par cryoablation

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2002007628A2 (fr) * 2000-07-19 2002-01-31 Cryovascular Systems, Inc. Catheter de cryotherapie presentant une securite amelioree
US7144418B1 (en) * 2001-11-02 2006-12-05 Medcool, Inc. Method, and system for selective cerebral hypothermia
US20060253095A1 (en) * 2002-01-16 2006-11-09 Radiant Medical, Inc. Method for gastric cooling using balloon catheter
US20040210281A1 (en) 2003-03-17 2004-10-21 Elizabeth Dzeng Transesophageal heat exchange catheter for cooling of the heart
WO2012019156A1 (fr) * 2010-08-05 2012-02-09 Medtronic Ardian Luxembourg S.A.R.L. Appareils, systèmes et procédés de neuromodulation rénale par cryoablation

Also Published As

Publication number Publication date
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