JP2008154751A - Cryotherapy equipment - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a new cryotherapy device capable of locally cooling only brain tissue in a short time.
A catheter (14) is inserted into a patient (P), and heat is exchanged between a refrigerant (M) flowing in the catheter (14) and blood flowing in a blood vessel (V) of the patient (P). This is a low-temperature treatment device that cools blood. This cryotherapy apparatus includes a catheter (14) having a refrigerant supply passage (52, 116) and a refrigerant recovery passage (54, 118) connected to each other, a refrigerant supply passage (52, 116), and a refrigerant recovery passage (54). , 118), a transport pipe (68, 128) constituting a closed circuit (70, 130) for circulating the refrigerant together with the refrigerant supply passage (52, 116) and the refrigerant recovery passage (54, 118), and a closed circuit (70, 130) and the cooling supply means (72, 132) for cooling the refrigerant (M) flowing through the closed circuit (70, 130) and supplying the refrigerant (M) to the refrigerant supply passage (52, 116). ).
[Selection] Figure 3

Description

  The present invention relates to a cryotherapy apparatus that can be used particularly for the treatment of ischemic cerebral infarction.

  Ischemic cerebral infarction is a disease caused by clogging of cerebral arterioles with blood clots, clots, fat masses, limestone fragments, tumor masses, etc., stopping blood flow and depriving the brain of oxygen. As a treatment method for the acute phase, thrombolytic therapy using a thrombolytic agent called tissue plasminogen activator (tPA) is known. However, if tissue plasminogen activator (tPA) is not administered within about 3 hours after the onset of cerebral infarction, it will not be effective, and if accidentally administered to a patient with hemorrhagic stroke, it will cause severe bleeding and death There is a problem that it is necessary to carefully judge whether to use because of the danger. Under such circumstances, in recent years, several cerebral cryotherapy has been proposed as a method for treating ischemic cerebral infarction, and its effectiveness has been demonstrated (Patent Document 1).

Conventionally proposed brain cryotherapy can be classified into a trunk cooling method that cools the whole body using a water-cooled blanket, a neck cooling method that cools the neck using a water-cooled muffler, and a head cooling method that uses a cooling helmet. However, although all of these cooling methods are preferable in that they are non-invasive, since they are intended to cool the brain from outside the body, the brain tissue temperature is set to an appropriate temperature (specifically, Celsius). It takes a long time to cool to 32 to 34 degrees. In particular, the trunk cooling method using a bracket has a problem that the apparatus is large and the place of use is limited, and the risk of infection and bleeding increases due to a decrease in body temperature.
JP 2002-119586 A

  Therefore, an object of the present invention is to provide a new cryotherapy apparatus that can cool only brain tissue locally in a short time instead of the conventionally proposed brain cryotherapy.

  In order to achieve this object, the cryotherapy apparatus of the present invention inserts the catheter (14) into the patient (P), the refrigerant (M) flowing through the catheter (14), and the blood vessels (V) of the patient (P). ) To cool the blood by exchanging heat with the blood flowing through it, and a catheter (5, 118) and a refrigerant recovery passage (54, 118) connected to each other ( 14), connected to the refrigerant supply passage (52, 116) and the refrigerant recovery passage (54, 118), and together with the refrigerant supply passage (52, 116) and the refrigerant recovery passage (54, 118), closed for circulating the refrigerant. A transport pipe (68, 128) constituting the circuit (70, 130), a refrigerant (M) accommodated in the closed circuit (70, 130), and a refrigerant (M) flowing through the closed circuit (70, 130). Cool the above refrigerant supply Characterized by comprising the road (52,116) cooling supply means for supplying (72,132).

  According to the cryotherapy apparatus employing such a configuration, the catheter is inserted into the carotid artery or placed adjacent to the carotid artery, for example. Since the blood supplied to the brain tissue through the artery can be cooled directly, brain damage can be treated without damaging the patient.

  Embodiments of a cryotherapy apparatus according to the present invention will be described below with reference to the accompanying drawings. In the following description, the terms “up”, “down”, “right”, and “left” are used as appropriate to describe the location and direction of each part shown in the drawings. It is for the purpose of facilitating the understanding of the invention, and should not be used to define other purposes, for example, the technical scope of the invention.

Embodiment 1
FIG. 1 shows the appearance of a cryotherapy apparatus according to the present invention. As shown in the figure, a low-temperature treatment device (brain temperature control device) 10 includes a main unit (main body) 12, a cooling unit 14 inserted into a patient's body that requires brain low-temperature therapy, a main unit 12, and a cooling unit. 14 has a tube unit 16 connected thereto.

  The main unit 12 has a box-shaped housing 18 in the embodiment. The housing 18 preferably includes an operation unit 20 and a display unit 22. The operation unit 20 includes a plurality of input buttons or input switches, and the display unit 22 includes one or a plurality of display screens (for example, a liquid crystal display).

  Referring to FIG. 2, the cooling unit 14 includes a cooling catheter (cooling tube) 24 that is inserted into the blood vessel of a patient in need of cerebral cryotherapy (eg, an ischemic encephalopathy patient). The catheter 24 has an outer tube 26. In the embodiment, the outer tube 26 has a size and a shape that can be inserted into the carotid artery (the common carotid artery, the external carotid artery, or the internal carotid artery) (see FIG. 3). Specifically, the outer tube 26 of the embodiment has an outer diameter φ of about 6 to 9 mm and a length L of about 10 to 15 cm. Actually, various sizes (outer diameters, lengths) corresponding to the insertion site (the common carotid artery, the external carotid artery, the internal carotid artery, etc.) of the catheter 24 are prepared. Depending on the insertion site, an appropriate size is selected.

  In order to reduce resistance when the outer tube 26 is inserted into the carotid artery and prevent damage to the carotid artery, the closed end portion 28 has a spherical shape (semispherical, warhead-shaped) having a smooth curve. A connector 32 detachably connected to the tube unit 16 is fixed to the open base end portion 30 of the outer tube 26.

  The outer tube 26 can be formed of a biocompatible metal (for example, stainless steel or an alloy thereof, titanium or an alloy thereof) or a resin (for example, polytetrafluoroethylene). In order to prevent blood from coagulating on the outer surface of the outer tube 26 and blocking the blood vessel, titanium or an alloy thereof is preferably used as the metal. In the case of an outer tube made of either metal or resin, it is preferable to apply a material that inhibits blood coagulation (anticoagulant: for example, heparin) to the outer peripheral surface of the outer tube.

  An inner tube 34 is accommodated in the outer tube 26. As shown in FIG. 4, the outer diameter of the inner tube 34 is smaller than the inner diameter of the outer tube 26, and a fluid (actually the refrigerant M) is interposed between the inner peripheral surface of the outer tube 26 and the outer peripheral surface of the inner tube 34. ) Through which an outer passage 36 flows. In the embodiment, as shown in the figure, the open end portion 38 of the inner tube 34 is retreated to the right side in the drawing from the end portion 28 of the outer tube 26, and the refrigerant is injected in front of the open end portion 38 (left side in the drawing). A space 40 is formed.

  In order to stably form the outer passage 36, it is preferable to mount and fix a ring-shaped spacer 40 on the outer side of the inner tube 34 at a predetermined interval in the axial direction as shown in FIGS. . As a matter of course, the spacer 40 has a plurality of openings 42 so that the refrigerant M can move in the outer passage 36.

  The end portion 38 of the inner tube 34 is processed into a hemispherical shape, for example, like the outer tube end portion 28, and a refrigerant injection hole (nozzle) 46 is formed at the center thereof. Although only one refrigerant injection hole is shown in the drawing, a plurality of refrigerant injection holes may be formed in axial symmetry. As shown in the drawing, the inner diameter of the refrigerant injection hole 46 is smaller than the inner diameter of the inner passage 48 formed inside the inner tube 34, and the inner passage 48 is supplied from the right side to the left side in FIG. The refrigerant M is ejected vigorously from the refrigerant injection hole 46 into the refrigerant injection space 40.

  As shown in FIG. 2, the proximal end portion 50 of the inner tube 34 is connected to and fixed to the connector 32. Inside the connector 32, two passages extending in the axial direction—a refrigerant supply passage 52 and a refrigerant recovery passage 54—are formed, and the refrigerant supply passage 52 is connected to the proximal end portion of the inner pipe 34 (inner passage 48). The refrigerant recovery passage 54 is connected to the base end portion of the outer passage 36.

  As shown in FIG. 1, the tube unit 16 has a flexible protective tube 56 made of resin or metal. As shown in FIG. 2, a flexible refrigerant supply tube 58 and a refrigerant recovery tube 60 made of resin or metal are accommodated in the protective tube 56. A connector 62 is fixed to the end of the protective tube 56. Inside the connector 62, two passages extending in the axial direction—the refrigerant supply passage 64 and the refrigerant recovery passage 66 — are formed. The end of the refrigerant supply tube 58 is connected to the refrigerant supply passage 64, and the refrigerant recovery tube 60. Is connected to the refrigerant recovery passage 66.

  The connectors 32 and 62 can be connected and disconnected with a single touch, such as a connector used for connecting a hydraulic device or a hydraulic hose. When the connectors 32 and 62 are separated, the refrigerant supply passages 52 and 62 are connected to each other. 64 and the refrigerant recovery passages 54 and 66 are preferably closed, and the refrigerant supply passages 52 and 64 and the refrigerant recovery passages 54 and 66 are connected to each other in a state where the connectors 32 and 62 are connected.

  As shown in FIG. 6, the proximal ends of the refrigerant supply tube 58 and the refrigerant recovery tube 60 are connected to both ends of the refrigerant transport pipe 68 disposed in the main unit 12, and the refrigerant supply tube 58 and the inner side described above are connected. The passage 48, the outer passage 36, and the refrigerant recovery tube 60 form a refrigerant circulation circuit (closed circuit) 70 together with the refrigerant transport pipe 68. In order to allow the tube unit 16 to be attached to and detached from the main unit 12, it is preferable to use a connector similar to the connectors 32 and 62 for connection between the base end portion of the tube unit 16 and the corresponding connection portion of the main unit 12. .

  Referring to FIG. 6, a compressor 72 and a condenser 74 are accommodated in the housing 18 of the main unit 12, and these are connected to the refrigerant circulation circuit 70 described above. The compressor 72 is electrically connected to the control unit 76 so that the compressor 72 can be adjusted based on a control signal output from the control unit 76. The control unit 76 is also connected to the operation unit 20 and the display unit 22. The control unit 76 is further connected to a thermometer 78 that detects the temperature of the patient. For example, an ear thermometer is preferably used as the thermometer.

  As other means for confirming and controlling the cooling effect of the brain, as shown in FIGS. It is preferable to detect the output of these temperature sensors 80 by the control unit 76. In this case, the electrical wiring 82 (not shown in FIG. 4) that electrically connects the temperature sensor 80 and the control unit 76 is disposed in an electrically insulated state on the outer surface or the inner surface of the outer tube 26, for example. The Further, the connectors 32 and 62 are provided with electrical connection portions or contacts (not shown), and the electrical wiring 82 is electrically connected to the control portion 76 by connecting the connectors 32 and 62. ing.

  The operation of the cryotherapy apparatus 10 having the above configuration will be described. First, as shown in FIG. 3, the catheter 24 is inserted into the carotid artery V of the ischemic cerebral disorder patient P in the same manner as the intravascular operation. At this time, the patient's P neck is percutaneously punctured, a sheath (tube) is inserted into the carotid artery, and the catheter 24 is inserted into the carotid artery via the sheath. Next, hemostasis is performed at the catheter insertion port of the blood vessel, and the catheter 24 is fixed to the neck using an appropriate indwelling means. A thermometer 78 is attached to the patient. Furthermore, according to the conventional Seldinger method, a catheter with a thermometer may be inserted from the femoral artery or the brachial artery, and the output from this thermometer may be input to the controller 76.

  When preparation is completed as described above, a treatment start switch (not shown) of the operation unit 20 is turned on. Upon receiving the treatment start switch ON signal, the control unit 76 activates the compressor 72 based on a brain temperature management program (not shown) stored in the control unit 76 (storage unit). As a result, the refrigerant M filled in the refrigerant circulation circuit 70 is compressed. The compressed refrigerant M is condensed by the condenser 74. The condensed refrigerant M is supplied to the inner passage 48 of the catheter 24 through the refrigerant supply tube 58 of the tube unit 16 and then injected into the refrigerant injection space 40 through the refrigerant injection hole 46 at the end of the inner tube 34. . At this time, the refrigerant M injected from the refrigerant injection hole 46 adiabatically expands to become a low-temperature refrigerant. Then, the low-temperature refrigerant M flowing from the refrigerant injection space 40 and from there to the outer passage 36 absorbs heat from the blood flowing around the catheter 24. The refrigerant M that has absorbed heat is recovered from the outer passage 36 of the catheter 24 to the compressor 72 via the refrigerant recovery tube 60 and the refrigerant transport pipe 68. In this way, the refrigerant is repeatedly circulated through the refrigerant circulation circuit 70, so that only the blood flowing toward the brain in the carotid artery, particularly the internal carotid artery, is directly cooled while maintaining a normal body temperature in parts other than the brain. It is possible to stop the progression of ischemic brain damage and prevent the brain tissue from being seriously damaged.

  The management of the brain temperature is based on an output from a temperature sensor 80 that detects the temperature of blood flowing through the carotid artery, a thermometer (ear thermometer) 78, and a thermometer of a catheter inserted from the femoral artery or brachial artery. Further, the control unit 76 controls the drive of the compressor 72. The brain temperature and the change (graph) are displayed on the liquid crystal display of the display unit 22.

<Modification>
In the above-described embodiment, in order to facilitate insertion of the catheter 24 into the blood vessel, an axial guide hole extending from the vicinity of the proximal end of the catheter 24 to the distal end is formed in the peripheral wall of the catheter outer tube 26 as shown in FIGS. 82, and the catheter 24 is preferably inserted into the carotid artery by the guide wire 84 inserted into the guide hole 82. In this case, for example, as shown in the figure, the outer tube 26 may be coated with a biocompatible resin (for example, polytetrafluoroethylene), and the guide hole 82 may be formed directly in the coating 86. Alternatively, as shown in FIG. 9, a sheath tube 88 may be disposed in the covering 86 and the inside of the sheath tube 88 may be used as the guide hole 82.

  In the above-described embodiment, the outer tube 26 is a straight tube, but a necessary portion (for example, a proximal end portion) may be slightly curved.

  Furthermore, in the above-described embodiment, the outer tube 26 is a straight tube having a uniform cross section. However, as shown in FIG. 10, when a metal tube is used for the outer tube 26, the outer tube 26 is almost entirely formed. Or you may form the deformable part 92 which connected the peak part 88 and the trough part 90 alternately. On the other hand, when a resin tube such as polytetrafluoroethylene is used for the outer tube 26, as shown in FIG. 11, a predetermined interval is provided on the outer peripheral surface of the outer tube 26 almost entirely or partially. The peak portion 94 may be formed, and thereby the deformable portion 94 may be formed. In these cases, the contact area between the outer tube 26 and the blood is significantly increased, heat transfer from the outer tube 26 to the blood is performed efficiently, and the brain tissue can be cooled in a shorter time.

  Furthermore, a plurality of grooves 96 extending in the axial direction may be formed on the outer peripheral surface of the outer tube 26 at regular intervals in the circumferential direction. In this case, the contact area between the outer tube 26 and blood is remarkably increased, heat transfer from the outer tube 26 to the blood is performed efficiently, and the brain tissue can be cooled in a shorter time.

  In the above embodiment, the catheter is inserted into the blood vessel. However, the blood in the blood vessel can be cooled from the outside of the blood vessel by bringing it into contact with the outer peripheral surface of the blood vessel. In this case, in order to increase the contact area between the blood vessel and the catheter as much as possible, as shown in FIG. 13, the cross-sectional shape of the catheter outer tube 26 may be arched, arcuate, semicircular, or U-shaped. .

  Further, in order to detect the leakage of the refrigerant from the refrigerant circulation circuit, a pressure sensor may be attached as a pressure detection means at an appropriate location of the refrigerant circulation circuit.

  Further, in the above description, FIG. 3 shows a state where the catheter is inserted into the internal carotid artery V2, but the catheter may be inserted into the common carotid artery V1. In this case, a catheter can be inserted (retrograde insertion) from the external carotid artery V3 toward the common carotid artery V1.

  Furthermore, the flow of blood flowing from the internal carotid artery toward the brain may be confirmed by detecting the catheter inserted into the carotid artery and the blood flow around it with an ultrasonic diagnostic apparatus. Further, in order to reliably insert the catheter into the carotid artery, the puncture state can be confirmed with an ultrasonic diagnostic apparatus.

<< Embodiment 2 >>
14 to 16 show the cryotherapy apparatus 100 according to the second embodiment. The cryotherapy apparatus 100 has a cooling catheter 112. The main body 114 of the catheter 112 is composed of a rod made of biocompatible metal or resin, and includes a plurality of refrigerant circulation passages-refrigerant supply passages 116 and refrigerant recovery passages 118- extending in the axial direction. A distal end portion 120 of the catheter 112 has a chamber (inner lumen) 122 formed therein, and a plurality of refrigerant supply passages 116 and a refrigerant recovery passage 118 formed in the main body 114 are connected thereto.

  A refrigerant cooling unit 124 is connected to the distal end portion of the catheter body 114. The cooling unit 124 has a housing 126 fixed to the distal end of the catheter body 114. Inside the housing 126, a refrigerant supply passage 116 and a refrigerant transport pipe 128 connected to the end of the refrigerant recovery passage 118 are connected, whereby the refrigerant supply passage 116, the chamber, the refrigerant recovery passage 118, and the refrigerant transport pipe. A refrigerant circulation path (closed loop) 130 connecting 128 is formed. The refrigerant transport pipe 128 is connected to a refrigerant transport pump 132, and the refrigerant M (see FIG. 16) is circulated and transported through the refrigerant circulation path 134 based on the driving of the pump 132. The pump 132 is preferably a small micro pump.

  The cooling unit 124 also includes a cooler or cooling coil 134. In the embodiment, the cooling coil 134 is wound around the refrigerant transport pipe 128, and heat exchange is efficiently performed between the refrigerant flowing in the cooling coil 132 and the refrigerant M flowing in the refrigerant transport pipe 128. It is preferable to do so.

  The cooling coil 134 is connected to the main unit 136 having the same configuration as that of the main unit 12 of the low-temperature treatment apparatus 10 according to the first embodiment described above, and the temperature of the refrigerant transported to the cooling coil 134 based on a command from the control unit. The amount is controlled.

  Although not shown, a plurality of temperature (brain temperature) detection means (same as the thermometer 78, the temperature sensor 80, and the thermometer) are prepared as in the first embodiment. The pump 132 is electrically connected to the control unit and is driven based on a command from the control unit.

  According to the cryotherapy apparatus 100 of the second embodiment configured as described above, as in the first embodiment, the refrigerant M in the refrigerant circulation path 130 drives the pump 132 while the catheter 112 is inserted into the carotid artery. Circulates through the refrigerant circulation path 130 based on the above. At this time, the refrigerant M in the refrigerant circuit 130 is cooled by the refrigerant supplied from the main unit 136 to the cooling coil 134. The cooled refrigerant M moves through the refrigerant supply passage 116, the end chamber 122, and the refrigerant recovery passage 118, and cools the blood flowing through the carotid artery as in the first embodiment. Further, based on the blood flow temperature detected by the temperature detection sensor, the body temperature measured by the thermometer, and the like, the control unit controls the driving of the pump 132 and the compressor according to the brain temperature management program.

  Note that all the various modifications described in connection with the first embodiment are also applicable to the cryotherapy apparatus of the second embodiment.

  The present invention also includes a low-temperature treatment method using the above-described low-temperature treatment device. In this treatment method, the catheter (14) is inserted into the carotid artery or other artery of the patient (P), and the catheter (14) The blood is cooled by exchanging heat between the refrigerant (M) flowing in the blood and the blood flowing in the blood vessel (V) of the patient (P).

The perspective view which shows the whole cryotherapy apparatus concerning this invention. The front view which shows the catheter which concerns on Embodiment 1 of the cryotherapy apparatus shown in FIG. The figure which shows the state which inserted the catheter shown in FIG. 2 in the patient's carotid artery. The partial expanded sectional view of the catheter shown in FIG. VV sectional view taken on the line of the catheter of FIG. The block diagram of the cryotherapy apparatus shown in FIG. The front view of the catheter of another form. VIII-VIII sectional view of the catheter shown in FIG. VIII-VIII sectional view of the catheter shown in FIG. The partial expanded side view of the catheter outer tube | pipe which concerns on another form. The partial expanded side view of the catheter outer tube | pipe which concerns on another form. The partial expanded sectional view of the catheter outer tube | pipe which concerns on another form. The partial expanded sectional view of the catheter which concerns on another form. FIG. 6 is a front view of a cryotherapy apparatus according to a second embodiment. The XV-XV line cross-sectional view of the catheter shown in FIG. FIG. 15 is an enlarged longitudinal sectional view of the catheter shown in FIG. 14.

Explanation of symbols

10: Cryogenic treatment device, 12: Main unit, 14: Cooling unit, 16: Tube unit, 18: Housing, 20: Operation part, 22: Display part, 24: Cooling catheter, 26: Outer tube, 28: Terminal part, 30: Base end part, 32: Connector, 34: Inner pipe, 36: Outer passage, 38: Terminal part, 40: Refrigerant injection space, 42: Spacer, 44: Opening part, 46: Refrigerant injection hole (nozzle), 48 : Inner passage, 50: base end, 52: refrigerant supply passage, 54: refrigerant recovery passage,
56: protection tube, 58: refrigerant supply tube, 60: refrigerant recovery tube, 62: connector, 64: refrigerant supply passage, 66: refrigerant recovery passage, 68: refrigerant transport tube, 70: refrigerant circulation circuit (closed circuit), 72 : Compressor, 74: condenser, 76: control unit, 78: thermometer, 80: temperature sensor, 82: guide hole, 84: guide wire, 86: coating, 88: mountain part, 90: valley part, 92: deformation Possible part, 94: deformable part, 100: cryotherapy device, 112: catheter, 114: body, 116: refrigerant supply passage, 118: refrigerant recovery passage, 120: end part, 122: chamber, 124: cooling unit, 126 : Housing, 128: Refrigerant transport pipe, 130: Refrigerant circuit, 132: Pump, 134: Cooling coil, 136: Main unit, P: Patient, V: Carotid artery, M: Refrigerant.

Claims (6)

By inserting the catheter (14) into the patient (P) and exchanging heat between the refrigerant (M) flowing in the catheter (14) and the blood flowing in the blood vessel (V) of the patient (P). A cryotherapy device for cooling the blood,
A catheter (14) having a refrigerant supply passage (52, 116) and a refrigerant recovery passage (54, 118) connected to each other;
The refrigerant supply passage (52, 116) and the refrigerant recovery passage (54, 118) are connected, and together with the refrigerant supply passage (52, 116) and the refrigerant recovery passage (54, 118), a closed circuit (70, 130) constituting the transport pipe (68, 128);
The refrigerant (M) contained in the closed circuit (70, 130);
A cryotherapy apparatus comprising cooling supply means (72, 132) for cooling the refrigerant (M) flowing through the closed circuit (70, 130) and supplying the refrigerant (M) to the refrigerant supply passage (52, 116).   The cryotherapy apparatus according to claim 1, characterized in that the catheter (14) has a cross section of a size and shape that can be inserted into a human blood vessel.   The cryotherapy apparatus according to claim 1 or 2, wherein the catheter (14) includes a temperature detector (80) for detecting the temperature of blood in the blood vessel. The cooling supply means includes a compressor (72), and includes a control unit (76) for controlling the compressor (72) based on the temperature detected by the temperature detector (80). The cryotherapy apparatus according to claim 3 The cooling supply means includes a pump (132), and includes a control unit (76) for controlling the pump (132) based on the temperature detected by the temperature detector (80). The cryotherapy apparatus according to claim 3. The cooling supply means includes a cooling coil (134) disposed in the vicinity of the transport pipe (128), and a compressor (72) for supplying a second refrigerant to the cooling coil (134). The cryotherapy apparatus according to claim 3, further comprising a control unit (76) for controlling the compressor (72) based on the temperature detected by the temperature detector (80).

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