JP5147004B2 - Balloon catheter used in a novel treatment method combining in vivo hyperthermia and arterial infusion chemotherapy under obstruction - Google Patents

Description

  The present invention relates to a balloon catheter used in a novel treatment method that combines in vivo hyperthermia and arterial infusion chemotherapy under obstruction.

  Cancer treatment methods include treatment methods such as surgery, chemotherapy, radiation therapy, and hyperthermia. Among them, the thermotherapy is a treatment method that damages or destroys cancer cells by heating cancer tissue to 43 ° C. or higher. However, a biological basis is clarified by a research started in the 1970s, and a heating device is used. It has spread rapidly with the development of In addition, hyperthermia has attracted attention in recent years because it has few side effects, can be effectively treated with a small amount of anticancer drugs when used in combination with chemotherapy or radiotherapy, and side effects are reduced.

  Hepatocellular carcinoma, a type of cancer, is increasing year by year, and the number of deaths from hepatocellular carcinoma is expected to continue to increase until around 2015. About 80% of hepatocellular carcinomas are caused by hepatitis C and 20% are caused by hepatitis B. Therefore, about 70% of patients with hepatocellular carcinoma are complicated by cirrhosis. Has fallen. Currently, hepatocellular carcinoma is treated with surgery, percutaneous ethanol infusion therapy, microwave coagulation therapy, radiofrequency ablation therapy, arterial embolization, chemotherapy (systemic chemotherapy, intraarterial infusion chemotherapy), radiation therapy, etc. Has been done.

  Moreover, although anticancer drug hepatic arterial infusion therapy has been carried out for frequently occurring hepatocellular carcinoma, it has been reported that the response rate is as low as about 40% (Non-patent Document 1). In addition to the hepatic arterial infusion therapy for anticancer drugs, there is a hepatic artery embolization treatment that obstructs a blood vessel that nourishes hepatocellular carcinoma and necroses, and thermotherapy with a thermotron (Patent Document 1). However, the above methods have problems that the effect is insufficient and the number of patients to be applied is limited due to a decrease in liver reserve capacity, the range of tumors, problems of side effects, and the like.

Higashihara et al., Hyperthermia for hepatocyte cellular carcinoma. Japanese clinical 59 (Suppl. 6): 650-653, 2001 Japanese Patent No. 3904241

  Therefore, development of a more effective treatment for hepatocellular carcinoma that can be applied to a wider range of patients with hepatocellular carcinoma is eagerly desired.

  The present invention has been made in view of the above circumstances, and an object of the present invention is to provide a treatment tool that enables a novel therapeutic method for hepatocellular carcinoma and to enhance the therapeutic effect and safety of hepatocellular carcinoma.

  It is believed that the most widely applied hepatocellular carcinoma treatment currently in use is the anticancer drug hepatic arterial infusion therapy. Anticancer drug hepatic arterial injection therapy is a method in which a catheter is inserted into the hepatic artery and an embolic substance such as jelly (gel part) or starch particles is administered. Up to now, it has been performed when the liver reserve ability is reduced or when tumors are frequently occurring in the liver. However, when the jelly is embolized, the jelly dissolves before the blood flow resumes. It took ~ 14 days. In that case, there is a problem that blood flow cannot be resumed even if the patient falls into liver failure after embolization, and the problem that the occlusion time cannot be adjusted and the side effects have not been solved yet. Therefore, in the present invention, a catheter having a balloon, a medicine discharge part and a heat generating part has been developed. The present invention overcomes the problems of the prior art because the occlusion time can be adjusted with a balloon, and thermotherapy can be performed with a heating part.

  That is, according to the present invention, the front end portion is provided with the heat generating portion, the drug releasing portion, and the balloon provided on the rear end side from the heat generating portion and the drug releasing portion, and the operator is provided at the rear end portion. An operation unit that receives an operation from the device, and a drug injection unit for injecting a drug released from the drug release unit. A balloon catheter is provided that includes an operation transmission unit that transmits an accepted operation to the heat generation unit and the balloon, and a liquid feeding unit that feeds the drug injected into the drug injection unit to the drug release unit. Since the present invention includes a balloon capable of adjusting expansion / contraction and a heat generating part capable of adjusting temperature, the degree of occlusion of the blood vessel can be adjusted, and the liver is locally heated at an arbitrary temperature, thereby causing cancer. Injures or necroses cells. In addition, since the arterial blood flow to hepatocellular carcinoma is reduced by blocking the blood flow of the balloon, the concentration of the anticancer drug injected from the front end side of the balloon increases dramatically, and further, the front end side of the balloon In addition, since it has a fever, it can be heated from the inside of hepatocellular carcinoma to enable efficient thermotherapy.

  According to the present invention, since it includes a balloon capable of adjusting expansion / contraction and a heat generating part capable of adjusting temperature, the occlusion time of the blood vessel can be adjusted, and the liver is locally heated at an arbitrary temperature, Cancer cells are damaged or necrotic. In addition, since the arterial blood flow to hepatocellular carcinoma is reduced by blocking the blood flow of the balloon, the concentration of the anticancer drug injected from the front end side of the balloon increases dramatically, and further, the front end side of the balloon In addition, since it has a fever, it can be heated from inside the tumor to enable efficient thermotherapy.

<Background of the invention>
In the past, anti-cancer drug intraarterial infusion therapy has been performed in the treatment of hepatocellular carcinoma such as when the liver reserve ability is reduced or when tumors are frequently occurring in the liver. Anticancer drug hepatic arterial infusion therapy is a treatment method in which a catheter is inserted into a hepatic artery, and the hepatic artery is embolized with lipiodol or an embolic substance and an anticancer drug is allowed to act. There are two types of inflow blood vessels in the liver: portal vein and hepatic artery. Since tumors in the liver do not have portal vein structure, most of the blood that feeds liver cancer comes from the hepatic artery. Therefore, if the hepatic artery is occluded, it is based on the idea that the tumor cells can be depleted and the anticancer agent can be effectively acted on and necrotic, but the occlusion time cannot be adjusted, When there is internal metastasis, there is a problem that it cannot be effectively treated. Accordingly, the present inventor has developed a catheter having a balloon with an adjustable expansion rate, a heat generating part with an adjustable temperature, and a drug releasing part. The present invention includes a balloon having an adjustable rate of expansion and a heat generating part having an adjustable temperature, whereby the degree of occlusion of the blood vessel can be adjusted, the liver is locally heated at an arbitrary temperature, and cancer The present invention has been completed which allows cells to be damaged or necrotic.

<Explanation of terms>
In this specification, the meaning of various terms shall be defined as follows.

(1) Balloon catheter “Balloon catheter” means a medical device having a balloon attached to the tip of an elongated tube (catheter). Here, a suitable structure can be selected for the catheter according to the situation, and may be, for example, a single lumen catheter, a double lumen catheter, a triple lumen catheter, or a quad lumen catheter. Moreover, the catheter can select the fineness suitable for the blood vessel made into the target, The diameter is 0.5 (tapering type)-4 mm, for example, Preferably it is 0.7-2 mm, More preferably, it is 1- It may be 1.7 mm. In addition, the balloon can be inflated and contracted to close the blood vessel, and those skilled in the art can select a suitable material and shape.
(2) Tip portion The “tip portion” means the tip portion of the catheter, and is a term that makes a pair with the rear end portion. In particular, it means a portion within 10 cm from the tip that is inserted into the hepatic artery. Here, “within 10 cm” means, for example, a length of 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, 9 cm, or 10 cm.

(3) Heat generating part The “heat generating part” means a part that generates heat. Here, in particular, those that can be adjusted to an arbitrary temperature by operation are preferable. For example, what can be heated to 43 to 45 ° C., 38 to 42 ° C., 46 to 59 ° C., 60 to 95 ° C., etc., for example, metal coils such as carbon steel and nichrome, carbon fiber, semiconductor, laser For example, light.

(4) Hyperthermia “Hyperthermia” is a therapy that warms the local area of a tumor, and its effect can be remarkably enhanced by using it together with radiation therapy or chemotherapy.
For thermotherapy, (1) hyperthermia: tumor can be heated to 43-45 ° C, (2) mild hyperthermia: tumor can be heated to 38-42 ° C, (3) super hyperthermia: tumor can be heated to 46-59 ° C (4) Ablative hyperthermia: heating the tumor to 60-95 ° C. The thermotherapy has the following advantages.
(I) Malignant tumor cells are more sensitive to heat than normal tissue cells.
In general, it is reported that the tumor has a lower pH than normal tissues, and cells at low pH are more sensitive to heat. Recently, it has become clear that cancer cells themselves are more sensitive to heat than normal cells.
(Ii) When a malignant tumor is heated, an increase in temperature is likely to be obtained.
In normal tissues, blood flow increases when heated, and the temperature is unlikely to rise due to the cooling effect.However, in blood flow, the blood flow does not increase or decreases in response to heating. The temperature tends to rise.
(Iii) Hyperthermia enhances the antitumor effect of radiation.
The antitumor effect is most noticeable when heat and radiation are applied simultaneously, but a certain degree of effect can be expected even when the administration time is not simultaneous. In general, radiation is effective in a portion having a high oxygen partial pressure around a capillary vessel, but the effect is reduced in a hypoxic portion far from the blood vessel. On the other hand, in hyperthermia, the farther away from the blood vessels, the easier the temperature rises and the effect of heat rises. Therefore, in addition to enhancing the antitumor effect by radiation, the effect of heat and radiation can be supplemented with each other . On the other hand, on the cell cycle, the radiation-resistant DNA synthesis phase (S phase) is conversely thermosensitive and the effect of the cell cycle using both of them may be almost eliminated.
(IV) Hyperthermia enhances the effects of anticancer drugs.
CDDP, MMC, bleomycin, adriamycin, 5-FU, ACNU, BCNO, cyclophosphamide, melphalan, Thio-TEPA, etc. are mentioned as those having an antitumor effect.
(V) Since once the tumor is heated, the tumor becomes heat resistant and the heat sensitivity is lowered. Therefore, it is desirable that the next thermotherapy is performed on and after the third day after the heat resistance disappears. Recently, once-weekly hyperthermia is mainly performed.
(Vi) There are few side effects.
Heating at 43 ° C. is in the physiological range for normal tissues and has fewer side effects on normal tissues than anticancer agents and the like.

(5) Drug “Drug” means any drug that can be used to treat hepatocellular carcinoma. Examples include anticancer agents such as rapamycin, mitomycin C, CDDP, MMC, bleomycin, adriamycin, 5-FU, ACNU, BCNO, cyclophosphamide, melphalan, Thio-TEPA, sorafenib, It can also be used as a mixture with gelatin-like substances. In addition, ionized fine metal particles or a magnetic material can be mixed and used as a drug. Here, the “drug release part” means a part where a drug is administered, and is not particularly limited as long as an effective amount of the drug can be administered into the hepatic artery according to the operation. Further, the “medicine injecting portion” means a portion into which a medicine is injected, and is not particularly limited as long as an effective amount of the medicine can be delivered to the medicine releasing portion via the liquid feeding portion. Those skilled in the art will understand the above structure.

(6) Operation “Operation” means an operation received by the operation unit or performed by the control unit, and the “operation” is transmitted to the heat generation unit, the drug release unit, and / or the balloon via the operation transmission unit. As a result, heat generation in the heat generating portion, drug discharge in the drug discharge portion, and inflation / deflation of the balloon occur.

(7) Temperature measurement part "Temperature measurement part" means the part which can measure temperature, and if the temperature of a target can be measured, it will not specifically limit. Examples thereof include a contact temperature sensor and a non-contact temperature sensor, and more specifically, a platinum resistance temperature detector, a thermistor, an electric heating pair, and the like. The temperature measurement unit is not an essential component of the balloon catheter, and can measure the temperature using another means. For example, by installing it at the distal end of another catheter, it can be brought closer to hepatocellular carcinoma than when it is installed on a balloon catheter, and the temperature inside the hepatocellular carcinoma can be directly measured.

(8) Pressure measuring part “Pressure measuring part” means a part capable of measuring pressure, and is not particularly limited as long as the pressure applied to the balloon can be measured. Examples thereof include a semiconductor strain gauge pressure sensor, a thin gauge pressure sensor, a piezoelectric pressure sensor, and an optical fiber pressure sensor, but are not limited thereto.

(9) Data transmission and data output The “measurement data output part” is a part for outputting measured data, and the output data is displayed via the data display part, and the output data or the displayed data is displayed. Based on the data, it is possible to adjust the fever of the exothermic part, the drug administration of the drug releasing part, the inflation / deflation of the balloon, and the like. The output data may be displayed via a display such as a monitor, or may be displayed by printing on paper or the like. The measured data can be transmitted to the measurement data output unit via the data transmission unit.

(10) Gelatin-like substance "Gelatin-like substance" means a gelatin-like substance that can embolize a blood vessel by coagulating in a blood vessel. By using it in a mixture with an anticancer agent, A cancer cell can be effectively necrotized. Those that can be dissolved by heating to adjust the occlusion time of the blood vessel are preferable, and those that dissolve at 42 ° C. to 45 ° C. are more preferable.

(11) Ionized fine metal particles or magnetic substance “Ionized fine metal particles or magnetic substance” means fine particles that generate heat when irradiated with electromagnetic waves, and can heat cancer from the inside. For example, Fe ^<2+> , Mg ^<2+> , Al ^<3+> , Zn ^<2+> etc. are mentioned.

(12) Radioactive fine particles “Radioactive fine particles” means fine particles that emit radiation such as γ-rays, and can be irradiated with radiation from the inside of cancer. For example, iodine 125 (onco seed radiation source, Nippon Mediphysics Co., Ltd.), radioactive iridium fine particles, and the like are injected, and the antitumor effect is exhibited by the synergistic effect of the heating effect and radiation. In addition, the retention of the radioactive substance in the tumor (stagnation) can be extended by occlusion of the nutritional blood vessels with the balloon. The particle diameter of iodine 125 is set to be larger than the diameter of the capillary blood vessel, which is 8 μm, for example, 10 μm to 800 μm.

  Embodiments of the present invention will be described below.

<Embodiment 1: Balloon catheter for treatment of hepatocellular carcinoma>
The balloon catheter of this embodiment is shown in FIG.
The balloon catheter of the present embodiment is in the form of a normal balloon catheter, and the catheter includes a tubular body 101 having a distal end 102 and a rear end 103 opposite to the distal end 102, and the distal end is made of carbon steel. A heating unit 104 having a coil inside and a medicine discharge unit 105 (a hole is not shown) is included, and a balloon 106 is formed at a position 3 cm from the tip. In addition, the rear end includes a drug injection unit 107 and an operation unit (an automatic operation unit 108 including a keyboard and a foot switch and a manual operation unit (not shown) including a syringe piston for pushing into the drug injection unit 107). Yes. The automatic operation unit 108 is connected to the heat generating unit 104 via a conducting wire 109 and to the balloon 106 via a communication unit (not shown).

  In FIG. 1, the automatic operation unit 108 including a keyboard and a foot switch is illustrated as the operation unit, but the configuration of the operation unit 108 is not limited to these. For example, the operation unit is electrically connected to a syringe piston for operating a balloon for simply applying pressure to air sent into the balloon 106 and pushing it into a communication unit (not shown), and a heating unit 104 having a carbon steel coil therein. The lead wire (not shown) may be configured by a dial for adjusting a current or voltage input from a power source (not shown). In this way, when performing operations based on mechanical control / electrical control, regardless of electronic control / software control, it is possible to prevent the operation from becoming unstable due to software errors, semiconductor chip failures, etc. And stable operation becomes possible. On the other hand, as shown in the figure, when performing electronic control and software control with a keyboard and foot switch, precise numerical control is possible, so even if a clumsy surgeon operates, the original design range There is an advantage that it is possible to operate with the accuracy within the range.

  In the present embodiment, the syringe piston for manipulating the medicinal solution in the medicinal injection unit 107 that simply pressurizes the medicinal solution released from the drug ejecting unit 105 and pushes it into the liquid feeding unit (not shown) is used as the operation unit. Not included in the concept. However, in a broad sense, a manual operation unit (not shown) including a syringe piston for pushing into the drug injection unit 107 can also be regarded as an operation unit. If a manual operation unit (not shown) composed of a syringe piston for pushing into the drug injection unit 107 is replaced with a configuration that can be automatically operated, the syringe piston is not manually moved back and forth, and the syringe piston is a motor or the like. Then, an automatic operation system may be constructed in which the operation of the motor is controlled by the illustrated keyboard or foot switch.

  In the balloon catheter of this embodiment, the operation received by the operation unit 108 can heat the heat generating unit 104 having a carbon steel coil to a target temperature range, and can expand and contract the balloon 106. The drug injection unit 107 is connected to the drug release unit 105 via the liquid delivery unit 111, and an effective amount of rapamycin can be administered from the drug release unit 105 by injecting rapamycin into the drug injection unit 107. .

  FIG. 2 shows the distal end portion 102 of the balloon catheter of the present embodiment. The balloon catheter of this embodiment may further include a platinum resistance thermometer temperature sensor 111 on the side surface of the distal end portion of the heat generating portion 104 as shown in FIG. In this way, by providing the platinum resistance thermometer temperature sensor 111 at a position closer to the tip than the balloon 106, when the balloon 106 is inflated to block the blood vessel and the blood stays, the staying blood It becomes possible to measure the temperature. The platinum resistance thermometer temperature sensor 111 is connected to the operation unit 108 via a conducting wire (not shown) in the tubular main body 101 and an electric cable 109, and can measure temperature by an operation received by the operation unit 108. . However, the platinum resistance thermometer temperature sensor 111 may be configured to automatically measure the ambient temperature without receiving an operation from the operation unit 108. The measured data is connected to the measurement data output unit 115 via a data transmission unit (not shown), and is displayed via the liquid crystal monitor 116.

  In addition, the balloon catheter of this embodiment may further include a semiconductor strain gauge pressure sensor (not shown) at the rear end portion 103. Since the balloon 106 and the semiconductor strain gauge pressure sensor (not shown) are connected via a communication portion (not shown) filled with air, the semiconductor strain gauge pressure sensor (not shown) is connected to the rear end. Even in the case of being installed in the portion 103, the pressure in the balloon 106 at the distal end portion can be measured. A semiconductor strain gauge pressure sensor (not shown) is connected to the operation unit 108 via an electric cable 109, and can measure pressure by an operation received by the operation unit 108. However, the semiconductor strain gauge type pressure sensor (not shown) may be configured to automatically measure the pressure of the air inside the communication unit without receiving any operation from the operation unit 108. The measured data is connected to the measurement data output unit 115 via the data transmission unit 114 and displayed via the liquid crystal monitor 116.

  FIG. 3 shows a modification of the distal end portion 102 of the balloon catheter of the present embodiment. As shown in FIG. 3, the balloon catheter of the present embodiment may include a platinum resistance thermometer temperature sensor 112 provided in a shape protruding to the distal end side of the heat generating portion 104. By adopting the structure shown in FIG. 3, the temperature of blood in the vicinity of hepatocellular carcinoma can be measured more. In addition, since the platinum resistance thermometer temperature sensor 112 having such a shape is provided so as to protrude toward the front end side of the heat generating portion 104, the influence of heat directly transmitted from the heat generating portion 104 can be reduced. This makes it possible to measure the temperature of the surrounding blood with higher accuracy.

  As shown in FIG. 4, a carbon steel coil 117 is provided inside the heat generating portion 104 of the balloon catheter of this embodiment, and this carbon steel coil 117 is dense at the front end portion, but extends toward the rear end side. It is sparse. By adopting such a structure, heat is generated only in the vicinity of hepatocellular carcinoma, and damage to the hepatic artery endothelial cells on the rear end side can be reduced. However, the carbon steel coil 117 is dense at the front end, but is not limited to a configuration that is sparse toward the rear end side, for example, it is not necessary to be coiled toward the rear end side, The conducting wire simply wired in a straight line may be used.

  Since the balloon catheter of this embodiment includes the heat generating part 104 whose temperature is adjustable, the liver is locally heated at an arbitrary temperature to damage or necrotize cancer cells. In addition, since the arterial blood flow to the hepatocellular carcinoma is reduced by the blockage of blood flow caused in the hepatic artery due to the expansion of the balloon 106, the concentration of the anticancer agent released from the distal end side of the balloon 106 is remarkably increased. To rise. In addition, since the heating part 104 is provided on the distal end side of the balloon 106, hepatic arterial blood staying in the liver is heated to a high temperature due to the expansion of the balloon 106, and efficient thermotherapy by heating from inside the tumor is possible. To. In addition, it has been shown that rapamycin, which inhibits angiogenesis, is further enhanced in hypoxia, so that the balloon 106 of the present embodiment retains the hepatic artery and stops supplying new oxygen. As a result, the area around hepatocellular carcinoma becomes hypoxic. Then, by injecting rapamycin from the drug releasing part 105 around the hepatocellular carcinoma in a hypoxic state, the antitumor effect is synergistically improved.

  The heat generating portion 104 in the present embodiment may be a metal coil such as carbon steel or nichrome. Here, although the carbon steel coil 117 is used, a nichrome coil, a Kanthal coil, etc. can also be used besides this. Moreover, although the heat generating part 104 in this embodiment is located 3 cm tip side from the balloon, it is not limited to this, 1 cm, 2 cm, 3 cm, 4 cm, 5 cm, 6 cm, 7 cm, 8 cm, It may be located 9 cm or 10 cm on the tip side. The position of the heat generating part 104 can be selected in consideration of the position of the hepatic artery to be blocked and the position of hepatocellular carcinoma.

  As described above, one or more platinum resistance thermometer temperature sensors 111 are installed as one or more temperature measuring units in the balloon catheter in the present embodiment. By installing one or more platinum resistance thermometer temperature sensors 111, it is possible to adjust the amount of heat generated by the heat generating unit 104 based on the measured temperature data, and the balloon 106 is inflated to retain hepatic arterial blood. In this case, the blood staying in the heat generating part 104 can be heated and maintained in the temperature range (43 to 45 ° C.) targeting the inside of the tumor.

  In the present embodiment, the temperature measuring unit 112 uses a platinum resistance thermometer, but a thermistor, an electric heating pair, or the like can also be used. Here, the platinum resistance thermometer 112 uses the property that the electric resistance of the metal changes with respect to the temperature change. Needless to say, other than platinum, a metal such as gold, titanium, copper, etc. is used. Can do.

  In addition, as described above, a semiconductor strain gauge type pressure sensor (not shown) is installed in the balloon catheter in the present embodiment as one or a plurality of pressure measuring units. Since the installed pressure measuring unit 113 is connected to the inside of the balloon 106 through the air in the communication unit (not shown), the pressure in the balloon 106 can be measured, and the balloon can be measured based on the measured pressure data. By adjusting the expansion / contraction of 106, hepatic artery blood vessels can be closed / opened, and blood flow can be blocked / resumed.

  The pressure measurement unit in this embodiment uses a semiconductor strain gauge pressure sensor (not shown), but in addition to this, a thin gauge pressure sensor, a piezoelectric pressure sensor, an optical fiber pressure sensor, or the like can be used. .

  Although the data display unit 116 in this embodiment uses a liquid crystal monitor, a CRT display, a plasma monitor, or the like can also be used.

Hereinafter, the effect of the balloon catheter of this embodiment is demonstrated.
As described above, the balloon catheter according to the present embodiment includes the heat generating portion 104, the drug releasing portion 105, and the balloon 106 provided on the rear end side of the heat generating portion 104 and the drug releasing portion 105 at the distal end portion 102. It is equipped with. In addition, the rear end portion 103 includes an operation unit 108 that receives an operation, and a drug injection unit 107 for injecting a drug released by the drug release unit 105. In addition, operation transmitting units 109 and 110 that transmit the operation received by the operation unit 108 to the heat generating unit 104 and the balloon 106 are provided in an intermediate portion provided between the distal end portion 102 and the rear end portion 103, and the drug injection unit 107. And a liquid delivery part 111 for delivering the medicine injected into the medicine release part 105.

  As described above, the balloon catheter of the present embodiment includes the balloon 106 capable of adjusting the expansion and contraction and the heat generating unit 104 capable of adjusting the temperature. Therefore, the degree of occlusion of the blood vessel can be adjusted, and the liver can be locally treated. The cancer cells can be damaged or necrotized by heating at any temperature. Moreover, since the arterial blood flow to the hepatocellular carcinoma is reduced by blocking the blood flow due to the inflation of the balloon 106, the concentration of the anticancer agent injected from the distal end side of the balloon can be dramatically increased. Furthermore, since the heat generating part 104 is provided on the distal end side of the balloon 106, the blood staying in the liver is heated by blocking the blood flow due to the expansion of the balloon 106, and the hepatocellular carcinoma is heated from the inside efficiently. Allows hyperthermia. In addition, since the occlusion time of the blood vessel by the balloon 106 can be adjusted, the embolization may be interrupted by reducing the balloon 106 when liver failure such as jaundice or hepatic encephalopathy occurs after the embolization. It becomes possible. In addition, by intermittently expanding and contracting the balloon 106, planned and continuous intermittent hepatic artery embolization can be performed.

  In the balloon catheter of the present embodiment, a power input unit (not shown) for inputting power to be supplied to the heat generating unit 104 and a gas or liquid for introduction into the balloon 106 are input to the rear end 103. And a gas-liquid input unit 107. Further, the operation transmission unit includes a power input unit (not shown) and a conductive wire (not shown) that electrically connects the heat generating unit 104, and a communication unit (not shown) that communicates between the gas-liquid input unit 107 and the balloon 106. ,have. The heating unit 104 includes a carbon steel coil 117 that is an electrothermal conversion unit that generates heat by converting electric power supplied from a power input unit (not shown) via a conductor (not shown) into heat. In addition, the operation unit 108 receives the operation content received from the operator as a current value or a voltage value transmitted from the power input unit (not shown) to the carbon steel coil 117 serving as the electrothermal conversion unit via a lead (not shown). And a gas-liquid amount or a gas-liquid pressure value transmitted from the gas-liquid input unit 107 to the inside of the balloon 106 via the communication unit 1 (not shown). Therefore, electric power is supplied from a power input unit (not shown) to the carbon steel coil 117 that is an electrothermal conversion unit via a conductive wire (not shown), and the carbon steel coil 117 that is an electrothermal conversion unit can generate heat. In addition, gas / liquid is supplied from the gas / liquid input unit 107 to the balloon 106 via a communication unit (not shown), and the balloon 106 can be inflated / deflated. Furthermore, since the received operation content is converted and transmitted as a current value, a voltage value, or a gas-liquid pressure value, the electrothermal conversion unit 104 can generate heat, and the balloon 106 can expand and contract. it can.

  Further, the electrothermal conversion unit 104 of the present embodiment is a heating coil. By using the heating coil, there is an advantage that the amount of generated heat can be easily adjusted.

  Further, the intermediate portion of the present embodiment is configured to have three or more lumens for isolating a liquid feeding portion (not shown), a conducting wire (not shown), and a communication portion (not shown). ing. By separating the liquid feeding part (not shown), the conducting wire (not shown), and the communication part (not shown), the medicine, the conducting wire, and the gas / liquid are not mixed, and corrosion of the conducting wire can be prevented.

  In addition, the balloon catheter of the present embodiment includes a platinum resistance thermometer temperature sensor 111 that is a temperature measuring unit for measuring an external temperature in the vicinity of the distal end portion 102 at the distal end portion 102. The rear end portion 103 includes a pressure measurement unit (not shown) for measuring the gas-liquid pressure inside the balloon 106 via the gas-liquid present in the communication unit (not shown), and a pressure measurement unit (not shown). And a measurement data output unit 115 for outputting measurement data of pressure and temperature measured by a platinum resistance thermometer temperature sensor 111 which is a temperature measurement unit. Furthermore, a transmission unit (not shown) that transmits measurement data of the temperature measured by the platinum resistance thermometer temperature sensor 111 that is a temperature measurement unit to the measurement data output unit 115 is provided in the intermediate unit. Thus, by using the measurement data of temperature and / or pressure, it is possible to perform hyperthermia at a more suitable temperature and occlusion of the blood vessel with a balloon.

  Further, the intermediate part of the present embodiment has four or more parts for isolating a liquid feeding part (not shown), a conducting wire (not shown), a communication part (not shown), and a transmitting part (not shown). It may be configured to have a lumen. By separating the liquid feeding (not shown), the conducting wire (not shown), the communicating part (not shown), and the transmitting part (not shown) from each other, the medicine, the conducting wire, the gas liquid, etc. are not mixed, and the conducting wire Corrosion can be prevented.

  FIG. 11 is a conceptual diagram for explaining a novel treatment method using in-vivo hyperthermia and arterial infusion chemotherapy using the balloon catheter of Embodiment 1 in combination. Here, as a problem in the conventional embolization treatment method, generally, when one main feeding blood vessel of hepatocellular carcinoma is crushed, more than 90% of hepatocellular carcinomas are necrotized temporarily due to the embolic effect. However, when the surviving hepatocellular carcinoma cells create countless (plural) new (nutrient) blood vessels by the action of angiogenic factors and try to re-treat, it is not clear which blood vessels should be embolized (number of nutrient blood vessels) This is technically impossible due to too much, or a new (nutrient) blood vessel such as the inferior phrenic artery or right adrenal artery is formed and becomes impossible to treat). On the other hand, blood flow in the inferior phrenic artery or right adrenal artery reduces the efficiency of anticancer drug perfusion into the tumor, even when trying to inject anticancer drugs for a long time with a catheter placed. The effect is insufficient. Uses Sponsels (dissolving in 10 days even after embolizing an artery) and starch particles (dissolving in a few hours after embolizing an artery), which is a conventional method of embolization, and using a platinum coil, which is a permanent embolic material The reason is not for the same reason.

  In general, a catheter is usually placed through a puncture site and placed in the abdominal aorta, celiac artery, intrinsic hepatic artery, etc. When the entire catheter is heated, the middle part of the catheter is Excessive heating and vascular injury can affect the celiac and aortic arteries. When the celiac artery is damaged due to the vascular injury caused by such heating and the stenosis is narrowed, the blood vessel at the branch also becomes ischemic, so that there is a risk of causing ischemic erosion or ulceration in the stomach or duodenum. Therefore, when the catheter is heated, 37 ° C., which is substantially the same as the body temperature, is ideal at the rear end portion and the intermediate portion of the catheter.

On the other hand, since the balloon catheter of the present embodiment employs the unique configuration as described above, the following problems that are difficult to be realized by the conventional treatment methods can be realized.
(1) The embolization time can be adjusted freely.
(2) It is possible to freely occlude / open a blood vessel by inflating / deflating the balloon (for example, expansion / contraction = 20 seconds / 10 seconds) at a certain interval.
(3) Since the pressure of the air inside the balloon can be adjusted, the degree of inflation of the balloon is selected as the degree of inflation suitable for the cross-sectional area of the blood vessel in which the balloon is placed, and the degree necessary and sufficient for occlusion / opening of the blood vessel Can be controlled.

  In addition, in the case of normal conventional embolization, hepatic artery embolization is a procedure that must be performed in a sterile condition in a laboratory after being hospitalized, and currently commonly performed embolization is performed intermittently. In some cases, embolization is performed three to six times while repeating the entrance and exit once a month at the earliest. However, in the balloon catheter of the present embodiment, it is possible to embolize the desired time zone for any time due to the effect (2) described above.

  Here, if the blood flow is blocked or partially occluded (50 to 95% of the blood vessel cross-sectional area) with a balloon, there is a risk that blood coagulation or thrombosis may occur due to blood flow stagnation or turbulence. Therefore, as a modification of the present embodiment, in addition to a lumen for drug solution, a lumen for balloon control, and a lumen for passing a heating wire so that an anticoagulant such as heparin can be filled in a blood vessel where blood flow is stagnant. In addition, a catheter having a plurality of lumens including a lumen for passing an anticoagulant such as heparin is used, and heparin is injected before the balloon is inflated to block blood flow. The above risk can be avoided by using a computer-controlled system.

  <Embodiment 2: Subcutaneous implantable balloon catheter>

  The subcutaneous implantable balloon catheter of this embodiment is shown in FIG. The basic structure of the balloon catheter of the present embodiment is the same as that described in the first embodiment, but it can also be used by being implanted subcutaneously by adopting the following unique structure.

  The subcutaneous implantable balloon catheter of the present embodiment includes a drug storage unit (not shown) connected to a drug injection unit (not shown) at the rear end 203, and a drug injection unit (not shown) from the drug storage unit (not shown). And a liquid injection adjusting unit (not shown) for adjusting the rate of injection of the medicine into the not shown. Note that both the drug storage unit (not shown) and the liquid injection adjusting unit (not shown) are stored in the subcutaneous implantation unit 208. The subcutaneous embedding unit 208 also stores an IC chip (not shown) on which a control unit 1100, which will be described later, is mounted, and a battery for driving the IC chip (not shown) and the liquid injection adjusting unit (not shown). Has been.

  That is, the control unit of the subcutaneous implantable balloon catheter according to the present embodiment is mounted on an IC chip, and stores a drug storage unit (not shown), a liquid injection adjusting unit (not shown), an operation unit (not shown), and a power source (not shown). ), A pump (not shown), and the like. Therefore, the patient's behavior is not limited, and QOL (Quality of Life) is improved. In addition, as the subcutaneous implantation portion 208, for example, a P-U cell site port (Toray Industries, Inc.), a vital port (Medicoshirata Corporation), or the like can be used.

  In another embodiment, only the drug storage unit (not shown) is stored in the subcutaneous implant unit 208, and a control unit (not shown), a liquid injection adjusting unit (not shown), an operation unit (not shown), which will be described later, A power source (not shown), a pump (not shown), etc. are arranged outside the body.

  Here, the liquid injection adjusting unit (not shown) is an ultra-small rotary pump (not shown), acquires a control signal from the control unit 1100, and adjusts its rotation speed. As a result, the rotary pump Since the flow rate of the drug solution flowing in the tube sandwiched between the two is adjusted, the drug injection speed can be adjusted with high accuracy. But this liquid injection adjustment part (not shown) is not necessarily limited to a micro rotary pump (not shown), For example, the micromotor provided with a piezoelectric element as a drive part may be sufficient. Also in this case, the drug injection rate can be adjusted with high accuracy although there are some pulsations. Alternatively, the liquid injection adjusting unit (not shown) may be a simple on-off valve, and the chemical solution inside the medicine storage unit (not shown) is naturally sucked out by capillary action when the on-off valve is opened. It may be in a format.

  Moreover, the functional block for demonstrating the structure of the control part 1100 of the subcutaneous implantable balloon catheter of this embodiment is shown in FIG. The control unit 1100 of this embodiment includes a time calculation unit 1102, a control data storage unit 1104, a data reading unit 1108, an operation determination unit 1110, and an operation signal input unit 1112. The time calculation unit 1102 calculates time data. The control data storage unit 1104 stores time-series control data set in advance to control the temperature of the heat generating unit 204, the amount of drug released from the drug discharge unit 205, and the pressure of the balloon 206 in time series. ing. The data reading unit 1108 reads measurement data from the measurement data output unit 215 and reads time-series control data 1106 from the control data storage unit 1104. The operation determination unit 1110 compares the time data calculated by the time calculation unit 1102, the measurement data read by the data reading unit, and the time-series control data 1106 read by the data reading unit, and compares the temperature of the heat generating unit 104. And the operation content for controlling the amount of medicine released from the medicine release unit 205 and the pressure of the balloon in time series. The operation signal input unit 1112 inputs the operation content determined by the operation determination unit to the time calculation unit 1102, the operation unit 214, and the liquid injection adjustment unit 1114 as an operation signal.

  FIG. 10 is a flowchart of the control method of the implantable balloon catheter according to the second embodiment. In the control unit 1100 of this embodiment, when the power is turned on and a series of control starts, first, the time calculation unit 1102 calculates time data (S102). On the other hand, the data reading unit 1108 reads measurement data from the measurement data output unit 215 and reads time-series control data 1106 from the control data storage unit 1104 (S104). Next, the operation determination unit 1110 compares the time data calculated by the time calculation unit 1102, the measurement data read by the data reading unit, and the time-series control data 1106 read by the data reading unit (S106).

  Subsequently, based on the above comparison result, the operation determination unit 1110 selects an operation content for controlling the temperature of the heat generation unit 104, the drug release amount from the drug release unit 205, and the balloon pressure in time series. It is determined whether it is A, B, C, or D (S108). Based on the determination result, the operation determination unit 1110 reads the operation content of the determined Option from among the options A, B, C, and D from the control data storage unit 1104 (S110, S112, S114, and S116). Next, the operation signal input unit 1112 inputs the operation content determined by the operation determination unit 1110 as an operation signal to the time calculation unit 1102, the operation unit 214, and the liquid injection adjustment unit 1114 (S118). Further, the operation signal input unit 1112 initializes the time count of the time calculation unit 1102. When the time count is initialized, the control unit 1100 receives a command to end a series of controls, such as when an instruction to turn off the power is input. Exit. On the other hand, when such an instruction has not been received yet, the time calculation unit 1102 repeats a series of controls starting from calculating time data (S102).

  In the subcutaneous implantable balloon catheter of this embodiment, the operation determination unit 1110 determines the operation content based on the measurement data and the time-series control data 1106, and transmits the operation signal from the operation signal input unit 1112. Since the balloon 206 is inflated and deflated, heated by the heat generating unit 204, and the amount of drug released from the drug releasing unit 205 is adjusted, heat generation, drug discharging, and blood vessel occlusion can be performed efficiently, and effective hepatocellular carcinoma Can be treated. In addition, the number of patient visits to be used is reduced and the patient's QOL (Quality of Life) is improved.

  <Embodiment 3: Control method of balloon catheter>

The method for controlling the balloon catheter according to this embodiment will be described below.
In this embodiment, the subcutaneously implantable balloon catheter shown in the second embodiment can be used.

(Embodiment 3-1) Treatment with a drug containing a mixture of an anticancer drug and a gelatin-like substance FIG. 6 shows that the drug stored in the drug reservoir of the balloon catheter of this embodiment is an anticancer drug and a gelatin-like drug. FIG. 6 shows a time span for control of a balloon catheter in the case of containing a mixture of substances. In this control method, the time calculation unit 1102 first calculates time data, and the data reading unit 1108 reads the measurement data from the measurement data output unit and reads the time-series control data 1106 from the control data storage unit 1104. Next, the operation determination unit 1110 compares the time data calculated by the time calculation unit 1102 with the measurement data read by the data reading unit 1108 and the time-series control data 1106 read by the data reading unit 1108.

  In the present embodiment, the liquid injection adjusting unit (not shown) is an ultra-small rotary pump (not shown), acquires a control signal from the control unit 1100, and adjusts its rotation speed. The flow rate of the chemical flowing through the tube sandwiched between the rotary pumps is adjusted. However, for the sake of simplicity, the rotation speed is constant when no control signal is received. And

  The operation determination unit 1110 determines the temperature of the heat generation unit 204 and the pressure inside the balloon 206 in advance if the first time (for example, 10 minutes from the start) in which the time data is set in advance has not elapsed. It is determined that the operation content (temperature: low temperature, balloon: deflation) for maintaining the value below the threshold value set in is to be performed. At this time, the mixture of the anticancer agent and gelatin-like substance already released from the drug releasing part 205 reaches hepatocellular carcinoma via the hepatic artery, and the blood vessel is embolized by the gelatin-like substance. Cell carcinoma will be necrotic.

  The operation determination unit 1110 has passed the first time in which the time data is set in advance, and if the second time (for example, 15 minutes from the start) has not elapsed, the operation determination unit 1110 It is determined that the operation content (temperature: high temperature, balloon: expansion) for changing the temperature and the pressure inside the balloon 206 to a predetermined threshold value or more should be performed. At this time, the blood vessel is occluded by the balloon 206, and the staying blood becomes hot due to the heat generated by the heat generating part 204, so that thermotherapy is performed and hepatocellular carcinoma is necrotic, and the gelatin-like substance is dissolved. Start.

  The operation determination unit 1110 determines that the time data has passed the second time set in advance and the third time (for example, 25 minutes from the start) has not elapsed, The operation content (temperature: high temperature, balloon: deflation) for changing the temperature above the preset threshold value and changing the pressure inside the balloon 206 below the preset threshold value should be performed. judge. At this time, the thermotherapy is continued, and the gelatin-like substance that has already occluded the blood vessels dissolved due to the high temperature flows out of the hepatic artery. Sufficient blood can be supplied to normal cells, avoiding the risk of patients suffering from liver failure.

  The operation determination unit 1110 has passed the third time in which the time data is set in advance, and has passed a predetermined time interval (for example, 30 minutes from the start) in which the time data is set in advance. If not, it is determined that drug injection from the drug storage unit to the drug injection unit should be started. As a result, the mixture of the anticancer agent and the gelatin-like substance is released from the drug releasing unit 205 and reaches hepatocellular carcinoma via the hepatic artery.

  Then, the operation determination unit 1110 stops the drug injection from the drug storage unit to the drug injection unit and initializes the count of the time calculation unit when the time data has reached a predetermined time zone. It is determined that it should be returned to. Next, the operation signal input unit 1112 inputs the operation content determined by the operation determination unit 1110 as an operation signal to the operation unit 214 and the liquid injection adjustment unit 1114, and then the above cycle is repeated. Hepatocellular carcinoma can be treated at predetermined intervals.

Here, the gelatin-like substance of the present embodiment may be any substance that occludes blood vessels, but is preferably one that dissolves by heating and can adjust the occlusion time of blood vessels, and dissolves at 42 ° C. to 45 ° C. Is more preferable. For example, DSM-TAE, Sponzel, or those whose melting temperature is improved may be mentioned. Any gelatin-like substance that satisfies such characteristics can be used to more effectively occlude blood vessels when used in combination with the balloon catheter of this embodiment.

(Embodiment 3-2) Treatment with Drug Containing Ionized Fine Metal Particles FIG. 7 shows the balloon catheter in the case where the drug stored in the drug reservoir of the balloon catheter of this embodiment contains ionized fine metal particles. It is a figure which shows the time span about control. In this control method, first, the time calculation unit 1102 calculates time data. Next, the data reading unit 1108 reads measurement data from the measurement data output unit, and reads time-series control data 1106 from the control data storage unit 1104. Next, the operation determination unit 1110 compares the time data calculated by the time calculation unit 1108, the measurement data read by the data reading unit 1108, and the time-series control data 1106 read by the data reading unit 1108.

  Also in the present embodiment, the liquid injection adjusting unit (not shown) is an ultra-small rotary pump (not shown), acquires a control signal from the control unit 1100, and its rotational speed is adjusted. As a result, the flow rate of the chemical liquid flowing in the tube sandwiched between the rotary pumps is adjusted. However, for the sake of simplification of explanation, the rotation speed is constant when no control signal is received. Shall.

  The operation determination unit 1110 determines the temperature of the heat generation unit 204 and the pressure inside the balloon 206 in advance when the first time (for example, 10 minutes from the start) in which the time data is set in advance has not elapsed. It is determined that the operation content (temperature: high temperature, balloon: inflated) to maintain the threshold value or higher should be performed. At this time, since the balloon 206 occludes the blood vessel, the ionized fine metal particles that have already been released from the drug releasing portion 205 have a high concentration in the hepatic artery, and further, by applying electromagnetic waves from the outside, thermotherapy is effective. Is effectively performed, and hepatocellular carcinoma is effectively necrotic.

  When the first time set in advance for the time data has passed and the second time (for example, 20 minutes from the start) has not passed, the operation determining unit 1110 It is determined that the operation content (temperature: low temperature, balloon: deflation) for changing the temperature and the pressure inside the balloon below a preset threshold should be performed. At this time, the balloon 206 is deflated, the blood flow is resumed, the temperature of the blood in the hepatic artery is lowered, the ionized fine metal particles have a low concentration in the hepatic artery, and the application of electromagnetic waves from the outside is stopped. Therefore, sufficient blood can be supplied to normal cells of the liver, and the risk of the patient falling into liver failure can be avoided.

  The operation determination unit 1110 generates a heat generation unit when the time data has passed the second time set in advance and has not reached a predetermined time interval (for example, 25 minutes from the start). The temperature of 204 and the pressure inside the balloon 206 should be fluctuated above a preset threshold (temperature: high temperature, balloon: inflated), and drug injection from the drug reservoir to the drug injection part should be started. judge. At this time, since the balloon 206 occludes the blood vessel, the concentration of the ionized fine metal particles released from the drug release unit 205 starts to increase in the hepatic artery.

  When the time data reaches a predetermined interval, the operation determination unit 1110 should stop the drug injection from the drug storage unit to the drug injection unit and return the count of the time calculation unit 1108 to the initial setting. It is determined that When the operation signal input unit 1112 inputs the operation content determined by the operation determination unit 1110 as an operation signal to the operation unit 214 and the liquid injection adjustment unit 1114, the above cycle is repeated thereafter, and a predetermined interval is obtained. Can treat hepatocellular carcinoma.

Here, the ionized fine metal particles of the present embodiment are preferably fine particles that generate heat when irradiated with electromagnetic waves such as iron (Fe ²⁺ ). Further, any material can be used as long as it can efficiently generate heat by electromagnetic waves and heat the cancer from the inside. In addition to iron (Fe ²⁺ ), magnesium (Mg ²⁺ ), aluminum (Al ³⁺ ), zinc (Zn ²⁺ ) Etc. can be used. The electromagnetic wave is not particularly limited, but can be applied from outside the body by using Thermotron-RF8 (Yamamoto Vinita Co., Ltd.) or the like. Since the ionized fine metal particles can be closer to hepatocellular carcinoma, it is possible to effectively perform thermotherapy.

(Embodiment 3-3) In the case where a rapamycin sustained-release stent is separately placed in the hepatic artery FIG. 8 shows that the drug stored in the drug reservoir of the balloon catheter of this embodiment is rapamycin, It is a figure which shows the time span about the control of a balloon catheter when the rapamycin sustained release stent is indwelling separately in the artery. In this control method, first, the time calculation unit 1102 calculates time data. Next, the data reading unit 1108 reads measurement data from the measurement data output unit, and reads time-series control data 1106 from the control data storage unit 1104. Next, the operation determination unit 1110 compares the time data calculated by the time calculation unit 1108, the measurement data read by the data reading unit 1108, and the time-series control data 1106 read by the data reading unit 1108.

  Also in the present embodiment, the liquid injection adjusting unit (not shown) is an ultra-small rotary pump (not shown), acquires a control signal from the control unit 1100, and its rotational speed is adjusted. As a result, the flow rate of the chemical liquid flowing in the tube sandwiched between the rotary pumps is adjusted. However, for the sake of simplification of explanation, the rotation speed is constant when no control signal is received. Shall.

  The operation determination unit 1110 determines the temperature of the heat generation unit 204 and the pressure inside the balloon 206 in advance when the first time (for example, 10 minutes from the start) in which the time data is set in advance has not elapsed. It is determined that the operation content (temperature: high temperature, balloon: inflated) to maintain the threshold value or higher should be performed. At this time, since the balloon 206 occludes the blood vessel, the rapamycin already released from the drug releasing portion 205 becomes a high concentration in the hepatic artery, and the sustained release amount from the rapamycin sustained release stent is increased by the heat generated by the heat generating portion 204. Therefore, hyperthermia and treatment with rapamycin are effectively performed, and hepatocellular carcinoma is effectively necrotized.

  When the first time set in advance for the time data has passed and the second time (for example, 20 minutes from the start) has not passed, the operation determining unit 1110 It is determined that the operation content (temperature: low temperature, balloon: deflation) for changing the temperature and the pressure inside the balloon below a preset threshold should be performed. At this time, since the blood flow is resumed by deflating the balloon 206, rapamycin flows out from the hepatic artery to lower the concentration, and the blood temperature also decreases to decrease the sustained release amount from the rapamycin sustained release stent. . Therefore, sufficient blood can be supplied to normal cells of the liver, and the risk of the patient falling into liver failure can be avoided.

  The operation determination unit 1110 generates a heat generation unit when the time data has passed the second time set in advance and has not reached a predetermined time interval (for example, 25 minutes from the start). The temperature of 204 and the pressure inside the balloon 206 should be fluctuated above a preset threshold (temperature: high temperature, balloon: inflated), and drug injection from the drug reservoir to the drug injection part should be started. judge. At this time, since the balloon 206 occludes the blood vessel, the concentration of rapamycin released from the drug releasing unit 205 in the hepatic artery begins to increase. Moreover, since the temperature of the blood in which the heat generating part 104 stays increases, the sustained release amount from the rapamycin sustained release stent increases. Therefore, hepatocellular carcinoma begins to die.

  When the time data reaches a predetermined interval, the operation determination unit 1110 should stop the drug injection from the drug storage unit to the drug injection unit and return the count of the time calculation unit 1108 to the initial setting. It is determined that When the operation signal input unit 1112 inputs the operation content determined by the operation determination unit 1110 as an operation signal to the operation unit 214 and the liquid injection adjustment unit 1114, the above cycle is repeated thereafter, and a predetermined interval is obtained. Can treat hepatocellular carcinoma.

  Here, the rapamycin sustained-release stent of the present embodiment is made of a biocompatible material such as titanium, but is formed so that rapamycin elutes gradually, such as by applying rapamycin. In addition, a stent made of a material whose rapamycin sustained release amount varies depending on the temperature may be used, and in that case, the rapamycin sustained release amount can be adjusted using the heat generating portion 204.

  In the balloon catheter control method according to the present embodiment, the operation determination unit 1110 determines the operation content based on the measurement data and the time-series control data 1106 and transmits the operation signal from the operation signal input unit 1112. Since the balloon 206 is inflated and deflated, heated by the heat generating unit 204, and the amount of drug released from the drug releasing unit 205 is adjusted, the risk of the patient falling into liver failure after embolization can be avoided, and the treatment used by the patient to be used The number of times decreases and the patient's QOL (Quality of Life) improves.

  Although the present invention has been described above, this embodiment is merely an example, and it will be understood by those skilled in the art that various modifications are possible and that such modifications are also within the scope of the present invention.

For example, as shown in FIG. 12, the tip 302 of the balloon catheter of the first embodiment can be formed into a needle shape, and a plurality of holes 301 for releasing a drug can be arranged on the side surface. Although arrangement | positioning of the hole 301 can be selected according to the magnitude | size of the hepatocellular carcinoma to treat, for example, it can install in the range of 5 mm-50 mm from a front-end | tip. Moreover, the carbon steel coil 303 is arrange | positioned helically so that it may not overlap with an opening part, For example, the range of 0 mm-55 mm from a catheter front-end | tip can be heated to arbitrary temperature. By making the tip into a needle shape and arranging a plurality of holes 301 on the side surface, it is possible to insert a balloon catheter into the hepatocellular carcinoma and heat it internally from the central axis of the tumor, and release the drug at the center of the tumor. Can be done from. In addition, the proximally installed balloon (not shown) can block the blood flow that flows into the liver tumor, allowing the anticancer drug to stay in the tumor for a long time.

In the first embodiment, the conducting wire 109, the communication cable (110), and the data transmission unit 114 are wired. However, wireless communication is achieved by using a set of wireless transmission / reception units arranged separately. You can also In the second embodiment, it can be wireless as well.

It is a figure which shows the balloon catheter of Embodiment 1. FIG. FIG. 3 is an enlarged view of a distal end portion of the balloon catheter according to the first embodiment. 6 is a modification of the distal end portion of the balloon catheter according to the first embodiment. It is a figure which shows the heat generating part of Embodiment 1 balloon catheter. 6 is a view showing an implantable balloon catheter according to Embodiment 2. FIG. It is a figure which shows the time span about control of the balloon catheter of Embodiment 3-1. It is a figure which shows the time span of the modification about control of the balloon catheter of Embodiment 3-2. It is a figure which shows the time span of the modification about control of the balloon catheter of Embodiment 3-3. FIG. 6 is a functional block diagram for explaining a control unit of the implantable balloon catheter according to the second embodiment. FIG. 6 is a flowchart illustrating a method for controlling an implantable balloon catheter according to a second embodiment. It is a conceptual diagram for demonstrating the novel treatment method which used together the in-vivo thermotherapy using the balloon catheter of Embodiment 1, and an arterial injection chemotherapy under obstruction | occlusion. 6 is a view showing a modification of the tip structure of the balloon catheter of Embodiment 1. FIG.

Explanation of symbols

DESCRIPTION OF SYMBOLS 101 ... Tubular main body 102 ... Front-end | tip part 103 ... Rear-end part 104 ... Heat-emitting part 105 ... Drug release part 106 ... Balloon 107 ... Drug injection part 108 ... Operation part 109 ... Conductor 110 ... Signal cable 111 ... Liquid sending part 112 ... Platinum measurement Thermal resistor 113 ... Semiconductor strain gauge pressure sensor 114 ... Data transmission unit 115 ... Data output unit 116 ... Liquid crystal monitor 117 ... Carbon steel coil 201 ... Tubular body 202 ... Front end 203 ... Rear end 204 ... Heat generation unit 205 ... Drug Release part 206 ... balloon 208 ... subcutaneous implant part 209 ... conducting wire 210 ... communication part 211 ... liquid sending part 212 ... data transmission part 213 ... platinum resistance thermometer 214 ... operation part 301 ... hole 302 ... tip part 303 ... carbon steel coil 1100 ... Control unit 1102 ... Time calculation unit 1104 ... Control data storage unit 1106 ... Time-series control data 1108 ... Data reading unit 1110 ... operation determining unit 1112 ... operation signal input unit 1114 ... instilling adjusting unit

Claims (21)

A balloon catheter,
At the needle-shaped tip,
A heating part;
A drug release part;
A balloon provided on the rear end side of the heat generating part and the drug releasing part;
With
At the rear end,
An operation unit for receiving an operation;
A drug injection part for injecting a drug released in the drug release part;
With
In an intermediate portion provided between the front end portion and the rear end portion,
An operation transmission unit that transmits the operation received by the operation unit to the heat generation unit and the balloon;
A liquid feeding section for feeding the drug injected into the drug injection section to the drug release section;
With
The drug release part is a plurality of holes arranged on a side surface of the needle-like tip part.
Balloon catheter. The balloon catheter according to claim 1,
The plurality of holes are installed in a range of 5 mm to 50 mm from the tip of the needle-like tip.
Balloon catheter. The balloon catheter according to claim 1 or 2,
The heat generating portion is arranged in a spiral shape so as not to overlap the openings of the plurality of holes,
Balloon catheter. The balloon catheter according to any one of claims 1 to 3 ,
Used for hepatocellular carcinoma treatment,
Balloon catheter. The balloon catheter according to any one of claims 1 to 4 ,
At the rear end,
A power input unit for inputting power to be supplied to the heat generating unit;
A gas-liquid input unit for inputting gas or liquid to be introduced into the balloon;
Further comprising
The operation transmission unit is
A conducting wire electrically connecting the power input unit and the heat generating unit;
A communication part communicating the gas-liquid input part and the inside of the balloon;
Have
The heating part is
An electric heat conversion unit that converts electric power supplied from the power input unit through the conductive unit into heat and generates heat;
The operation unit is
The received operation details
A current value or a voltage value transmitted from the power input unit to the electrothermal conversion unit and the communication unit via the conductive wire;
A gas-liquid amount or a gas-liquid pressure value transmitted from the gas-liquid input unit to the inside of the balloon through the communication unit;
Configured to convert to,
Balloon catheter. The balloon catheter according to claim 5 ,
The electrothermal converter is a heating coil.
Balloon catheter. The balloon catheter according to claim 5 or 6 ,
The intermediate portion is configured to have three or more lumens for isolating the liquid feeding portion, the conducting wire, and the communication portion from each other.
Balloon catheter. The balloon catheter according to any one of claims 5 to 7 ,
further,
The tip portion includes a temperature measuring unit for measuring an external temperature near the tip portion,
At the rear end,
A pressure measurement unit for measuring the gas-liquid pressure inside the balloon via the gas-liquid present in the communication unit;
A measurement data output unit that outputs measurement data of pressure and temperature measured by the pressure measurement unit and the temperature measurement unit;
With
The intermediate unit includes a transmission unit that transmits measurement data of the temperature measured by the temperature measurement unit to the measurement data output unit,
Balloon catheter. The balloon catheter according to claim 8 ,
The intermediate portion is configured to have four or more lumens for isolating the liquid feeding portion, the conducting wire, the communication portion, and the transmitting portion from each other.
Balloon catheter. The balloon catheter according to claim 8 or 9 ,
At the rear end,
A drug reservoir connected to the drug injection part;
An infusion adjustment unit that adjusts a drug injection rate from the drug storage unit to the drug injection unit;
A balloon catheter. The balloon catheter according to claim 10 ,
A time calculation unit for calculating time data;
A control data storage unit for storing time-series control data set in advance to control the temperature of the heat generation unit, the amount of drug released from the drug release unit, and the pressure of the balloon in time series; ,
A data reading unit for reading the measurement data from the measurement data output unit and reading the time-series control data from the control data storage unit;
By comparing the time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time-series control data read by the data reading unit, the temperature of the heating unit and the medicine An operation determination unit for determining the operation content for controlling the amount of medicine released from the discharge unit and the pressure of the balloon in time series;
An operation signal input unit that inputs the operation content determined by the operation determination unit to the time calculation unit, the operation unit, and the liquid injection adjustment unit as an operation signal,
Having
Balloon catheter. A balloon catheter,
At the tip,
A heating part;
A drug release part;
A balloon provided on the rear end side of the heat generating part and the drug releasing part;
A temperature measurement unit for measuring an external temperature near the tip, and
With
At the rear end,
An operation unit for receiving an operation;
A drug injection part for injecting a drug released in the drug release part;
A power input unit for inputting power to be supplied to the heat generating unit;
A gas-liquid input unit for inputting gas or liquid to be introduced into the balloon;
A pressure measurement unit for measuring the gas-liquid pressure inside the balloon via the gas-liquid present in the communication unit;
A measurement data output unit that outputs measurement data of pressure and temperature measured by the pressure measurement unit and the temperature measurement unit;
A drug reservoir connected to the drug injector, for storing a drug comprising a mixture of an anticancer agent and a gelatin-like substance;
An infusion adjustment unit that adjusts a drug injection rate from the drug storage unit to the drug injection unit;
With
In an intermediate portion provided between the front end portion and the rear end portion,
An operation transmission unit that transmits the operation received by the operation unit to the heat generation unit and the balloon;
A liquid feeding section for feeding the drug injected into the drug injection section to the drug release section;
A transmission unit for transmitting measurement data of the temperature measured by the temperature measurement unit to the measurement data output unit;
With
The operation transmission unit is
A conducting wire electrically connecting the power input unit and the heat generating unit;
A communication part communicating the gas-liquid input part and the inside of the balloon;
Have
The heating part is
An electric heat conversion unit that converts electric power supplied from the power input unit through the conductive unit into heat and generates heat;
The operation unit is
The received operation details
A current value or a voltage value transmitted from the power input unit to the electrothermal conversion unit and the communication unit via the conductive wire;
A gas-liquid amount or a gas-liquid pressure value transmitted from the gas-liquid input unit to the inside of the balloon through the communication unit;
Is configured to convert to
further,
A time calculation unit for calculating time data;
A control data storage unit for storing time-series control data set in advance to control the temperature of the heat generation unit, the amount of drug released from the drug release unit, and the pressure of the balloon in time series; ,
A data reading unit for reading the measurement data from the measurement data output unit and reading the time-series control data from the control data storage unit;
By comparing the time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time-series control data read by the data reading unit, the temperature of the heating unit and the medicine An operation determination unit for determining the operation content for controlling the amount of medicine released from the discharge unit and the pressure of the balloon in time series;
An operation signal input unit that inputs the operation content determined by the operation determination unit to the time calculation unit, the operation unit, and the liquid injection adjustment unit as an operation signal,
With
The operation determination unit compares the time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time-series control data read by the data reading unit,
In the time interval of the predetermined interval
When the time data has not passed the preset first time, the operation content for maintaining the temperature of the heat generating portion and the pressure inside the balloon below a preset threshold value Is determined to be
If the time data has passed the first time set in advance and the second time has not passed, the temperature of the heat generating part and the pressure inside the balloon are set in advance. It is determined that the operation content to be changed beyond the threshold value should be performed,
When the second time set in advance has passed and the third time has not passed, the temperature of the heat generating portion is changed to a preset threshold value or more. , It is determined that the operation content for changing the pressure inside the balloon to less than a preset threshold should be performed,
When the third time set in advance has elapsed and the predetermined time zone has not elapsed, the injection of the drug from the drug storage unit to the drug injection unit should be started. It is determined that
When the time data reaches the time interval of the predetermined interval, the medicine injection from the medicine storage part to the medicine injection part should be stopped, and the count of the time calculation part should be returned to the initial setting. Is configured to determine,
Balloon catheter. The balloon catheter according to claim 12 ,
Used for hepatocellular carcinoma treatment,
Balloon catheter. The balloon catheter according to claim 12 or 13 ,
The electrothermal converter is a heating coil.
Balloon catheter. The balloon catheter according to any one of claims 12 to 14 ,
The intermediate portion is configured to have three or more lumens for isolating the liquid feeding portion, the conducting wire, and the communication portion from each other.
Balloon catheter. The balloon catheter according to any one of claims 12 to 15 ,
The intermediate portion is configured to have four or more lumens for isolating the liquid feeding portion, the conducting wire, the communication portion, and the transmitting portion from each other.
Balloon catheter. The method for controlling a balloon catheter according to any one of claims 12 to 16 , wherein the drug stored in the drug storage unit includes a mixture of an anticancer drug and a gelatin-like substance.
The time calculation unit calculating the time data;
The data reading unit reads the measurement data from the measurement data output unit, and reads the time-series control data from the control data storage unit;
The operation determination unit compares the time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time-series control data read by the data reading unit,
In the time interval of the predetermined interval
When the time data has not passed the preset first time, the operation content for maintaining the temperature of the heat generating portion and the pressure inside the balloon below a preset threshold value Is determined to be
If the time data has passed the first time set in advance and the second time has not passed, the temperature of the heat generating part and the pressure inside the balloon are set in advance. It is determined that the operation content to be changed beyond the threshold value should be performed,
When the second time set in advance has passed and the third time has not passed, the temperature of the heat generating portion is changed to a preset threshold value or more. , It is determined that the operation content for changing the pressure inside the balloon to less than a preset threshold should be performed,
When the third time set in advance has elapsed and the predetermined time zone has not elapsed, the injection of the drug from the drug storage unit to the drug injection unit should be started. It is determined that
When the time data reaches the time interval of the predetermined interval, the medicine injection from the medicine storage part to the medicine injection part should be stopped, and the count of the time calculation part should be returned to the initial setting. A step of determining
The operation signal input unit inputs the operation content determined by the operation determination unit to the time calculation unit, the operation unit, and the injection adjustment unit as an operation signal;
including,
Control method of balloon catheter. A balloon catheter,
At the tip,
A heating part;
A drug release part;
A balloon provided on the rear end side of the heat generating part and the drug releasing part;
A temperature measurement unit for measuring an external temperature near the tip, and
With
At the rear end,
An operation unit for receiving an operation;
A drug injection part for injecting a drug released in the drug release part;
A power input unit for inputting power to be supplied to the heat generating unit;
A gas-liquid input unit for inputting gas or liquid to be introduced into the balloon;
A pressure measurement unit for measuring the gas-liquid pressure inside the balloon via the gas-liquid present in the communication unit;
A measurement data output unit that outputs measurement data of pressure and temperature measured by the pressure measurement unit and the temperature measurement unit;
A drug reservoir connected to the drug injector and for storing a drug containing ionized fine metal particles;
An infusion adjustment unit that adjusts a drug injection rate from the drug storage unit to the drug injection unit;
With
In an intermediate portion provided between the front end portion and the rear end portion,
An operation transmission unit that transmits the operation received by the operation unit to the heat generation unit and the balloon;
A liquid feeding section for feeding the drug injected into the drug injection section to the drug release section;
A transmission unit for transmitting measurement data of the temperature measured by the temperature measurement unit to the measurement data output unit;
With
The operation transmission unit is
A conducting wire electrically connecting the power input unit and the heat generating unit;
A communication part communicating the gas-liquid input part and the inside of the balloon;
Have
The heating part is
An electric heat conversion unit that converts electric power supplied from the power input unit through the conductive unit into heat and generates heat;
The operation unit is
The received operation details
A current value or a voltage value transmitted from the power input unit to the electrothermal conversion unit and the communication unit via the conductive wire;
A gas-liquid amount or a gas-liquid pressure value transmitted from the gas-liquid input unit to the inside of the balloon through the communication unit;
Is configured to convert to
further,
A time calculation unit for calculating time data;
A control data storage unit for storing time-series control data set in advance to control the temperature of the heat generation unit, the amount of drug released from the drug release unit, and the pressure of the balloon in time series; ,
A data reading unit for reading the measurement data from the measurement data output unit and reading the time-series control data from the control data storage unit;
By comparing the time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time-series control data read by the data reading unit, the temperature of the heating unit and the medicine An operation determination unit for determining the operation content for controlling the amount of medicine released from the discharge unit and the pressure of the balloon in time series;
An operation signal input unit that inputs the operation content determined by the operation determination unit to the time calculation unit, the operation unit, and the liquid injection adjustment unit as an operation signal,
With
The operation determination unit compares the time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time-series control data read by the data reading unit,
In the time interval of the predetermined interval
When the time data has not passed the preset first time, the operation content for maintaining the temperature of the heat generating portion and the pressure inside the balloon at or above a preset threshold value Is determined to be
If the time data has passed the first time set in advance and the second time has not passed, the temperature of the heat generating part and the pressure inside the balloon are set in advance. It is determined that the operation content for changing below the threshold value should be performed,
When the second time set in advance has passed and the time interval of the predetermined interval has not been reached, the temperature of the heat generating portion and the pressure inside the balloon are set in advance. Fluctuate more than a set threshold, determine that the drug injection from the drug storage unit to the drug injection unit should be started,
When the time data has reached the predetermined time interval, the medicine injection from the medicine storage part to the medicine injection part should be stopped and the count of the time calculation part should be returned to the initial setting Is configured to determine that
Balloon catheter. The method for controlling a balloon catheter according to claim 18 , wherein the drug stored in the drug storage unit includes ionized fine metal particles.
The time calculation unit of the balloon catheter calculates the time data;
The data reading unit reads the measurement data from the measurement data output unit, and reads the time-series control data from the control data storage unit;
The operation determination unit compares the time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time-series control data read by the data reading unit,
In the time interval of the predetermined interval
When the time data has not passed the preset first time, the operation content for maintaining the temperature of the heat generating portion and the pressure inside the balloon at or above a preset threshold value Is determined to be
If the time data has passed the first time set in advance and the second time has not passed, the temperature of the heat generating part and the pressure inside the balloon are set in advance. It is determined that the operation content for changing below the threshold value should be performed,
When the second time set in advance has passed and the time interval of the predetermined interval has not been reached, the temperature of the heat generating portion and the pressure inside the balloon are set in advance. Fluctuate more than a set threshold, determine that the drug injection from the drug storage unit to the drug injection unit should be started,
When the time data has reached the predetermined time interval, the medicine injection from the medicine storage part to the medicine injection part should be stopped and the count of the time calculation part should be returned to the initial setting Determining that
The operation signal input unit inputs the operation content determined by the operation determination unit to the time calculation unit, the operation unit, and the injection adjustment unit as an operation signal;
including,
Control method of balloon catheter. A balloon catheter for use when a rapamycin sustained release stent is separately placed in the hepatic artery ,
At the tip,
A heating part;
A drug release part;
A balloon provided on the rear end side of the heat generating part and the drug releasing part;
A temperature measurement unit for measuring an external temperature near the tip, and
With
At the rear end,
An operation unit for receiving an operation;
A drug injection part for injecting a drug released in the drug release part;
A power input unit for inputting power to be supplied to the heat generating unit;
A gas-liquid input unit for inputting gas or liquid to be introduced into the balloon;
A pressure measurement unit for measuring the gas-liquid pressure inside the balloon via the gas-liquid present in the communication unit;
A measurement data output unit that outputs measurement data of pressure and temperature measured by the pressure measurement unit and the temperature measurement unit;
A drug storage unit connected to the drug injection unit for storing a drug containing rapamycin;
An infusion adjustment unit that adjusts a drug injection rate from the drug storage unit to the drug injection unit;
With
In an intermediate portion provided between the front end portion and the rear end portion,
An operation transmission unit that transmits the operation received by the operation unit to the heat generation unit and the balloon;
A liquid feeding section for feeding the drug injected into the drug injection section to the drug release section;
A transmission unit for transmitting measurement data of the temperature measured by the temperature measurement unit to the measurement data output unit;
With
The operation transmission unit is
A conducting wire electrically connecting the power input unit and the heat generating unit;
A communication part communicating the gas-liquid input part and the inside of the balloon;
Have
The heating part is
An electric heat conversion unit that converts electric power supplied from the power input unit through the conductive unit into heat and generates heat;
The operation unit is
The received operation details
A current value or a voltage value transmitted from the power input unit to the electrothermal conversion unit and the communication unit via the conductive wire;
A gas-liquid amount or a gas-liquid pressure value transmitted from the gas-liquid input unit to the inside of the balloon through the communication unit;
Is configured to convert to
further,
A time calculation unit for calculating time data;
A control data storage unit for storing time-series control data set in advance to control the temperature of the heat generation unit, the amount of drug released from the drug release unit, and the pressure of the balloon in time series; ,
A data reading unit for reading the measurement data from the measurement data output unit and reading the time-series control data from the control data storage unit;
By comparing the time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time-series control data read by the data reading unit, the temperature of the heating unit and the medicine An operation determination unit for determining the operation content for controlling the amount of medicine released from the discharge unit and the pressure of the balloon in time series;
An operation signal input unit that inputs the operation content determined by the operation determination unit to the time calculation unit, the operation unit, and the liquid injection adjustment unit as an operation signal,
With
The time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time series control data read by the data reading unit are compared,
In the time interval of the predetermined interval
When the time data has not passed the preset first time, the operation content for maintaining the temperature of the heat generating portion and the pressure inside the balloon at or above a preset threshold value Is determined to be
If the time data has passed the first time set in advance and the second time has not passed, the temperature of the heat generating part and the pressure inside the balloon are set in advance. It is determined that the operation content for changing below the threshold value should be performed,
When the second time set in advance has passed and the time interval of the predetermined interval has not been reached, the temperature of the heat generating portion and the pressure inside the balloon are set in advance. Fluctuate more than a set threshold, determine that the drug injection from the drug storage unit to the drug injection unit should be started,
When the time data has reached the predetermined time interval, the medicine injection from the medicine storage part to the medicine injection part should be stopped and the count of the time calculation part should be returned to the initial setting Is configured to determine that
Balloon catheter. The method of controlling a balloon catheter according to claim 20 , wherein the drug stored in the drug storage unit is rapamycin, and a rapamycin sustained-release stent is separately placed in the hepatic artery,
The time calculation unit of the balloon catheter calculates the time data;
The data reading unit reads the measurement data from the measurement data output unit, and reads the time-series control data from the control data storage unit;
The operation determination unit compares the time data calculated by the time calculation unit, the measurement data read by the data reading unit, and the time-series control data read by the data reading unit,
In the time interval of the predetermined interval
When the time data has not passed the preset first time, the operation content for maintaining the temperature of the heat generating portion and the pressure inside the balloon at or above a preset threshold value Is determined to be
If the time data has passed the first time set in advance and the second time has not passed, the temperature of the heat generating part and the pressure inside the balloon are set in advance. It is determined that the operation content for changing below the threshold value should be performed,
When the second time set in advance has passed and the time interval of the predetermined interval has not been reached, the temperature of the heat generating portion and the pressure inside the balloon are set in advance. Fluctuate more than a set threshold, determine that the drug injection from the drug storage unit to the drug injection unit should be started,
When the time data has reached the predetermined time interval, the medicine injection from the medicine storage part to the medicine injection part should be stopped and the count of the time calculation part should be returned to the initial setting Determining that
The operation signal input unit inputs the operation content determined by the operation determination unit to the time calculation unit, the operation unit, and the injection adjustment unit as an operation signal;
including,
Control method of balloon catheter.