CN1214766C - Flexible cold knife probe for human body cavity tumor cryotherapy - Google Patents

Flexible cold knife probe for human body cavity tumor cryotherapy Download PDF

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Publication number
CN1214766C
CN1214766C CNB021042462A CN02104246A CN1214766C CN 1214766 C CN1214766 C CN 1214766C CN B021042462 A CNB021042462 A CN B021042462A CN 02104246 A CN02104246 A CN 02104246A CN 1214766 C CN1214766 C CN 1214766C
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freezing
flexible
probe
main body
tumor
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CN1440727A (en
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刘静
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Hygea Medical Technology Co Ltd
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Technical Institute of Physics and Chemistry of CAS
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Abstract

The invention relates to a flexible cold knife probe for freezing treatment of human body cavity tumor, which comprises a probe main body made of flexible material, wherein an inner sleeve is communicated with a liquid nitrogen (helium) bottle, an electric heating element is covered on the outer surface of the outer sleeve, and an insulating material is covered on the outer surface of the electric heating element; a temperature sensor is arranged between the probe and the probe body, and a heat insulation sheath with a heat insulation handle is arranged on the outer surface of the probe body; the end part of the freezing metal head positioned at the front end of the probe main body is an arc spherical surface, and a porous metal wire is filled in the freezing metal head; the inner sleeve of the probe body extends into the inner cavity of the probe body, and the inner cavity is communicated with the inner sleeve and the outer sleeve of the probe body; the end part of the freezing metal head is provided with a temperature sensor, the output end wire of the temperature sensor is connected with a data acquisition unit, and the data acquisition unit is connected with a computer; the device has no vacuum structure, small size, low cost and no insertion damage; the temperature reduction and rise can be adjusted, the response speed is high, the continuity is good, and the method is particularly suitable for treating the cavity tumors of nasopharyngeal carcinoma, digestive tract cancer, lung cancer, rectal cancer and the like.

Description

The flexible cryoprobe probe that is used for the cold therapy of body cavities tumor
Technical field
The present invention relates to the fine cryoprobe probe that the cold therapy of body cavities tumor is used, particularly a kind of flexible stylet main body outer wall is coated with electric heating film and utilizes the flexible cryoprobe probe that is used for the cold therapy of body cavities tumor as refrigerant such as liquid nitrogen.
Background technology
For a long time, rational therapy body tumor tissue is the target that clinical medicine is pursued always, developed so far and radiotherapy, chemotherapy, approach such as thermotherapy and cold therapy, in all kinds of Therapeutic Method, cryosurgery is owing to can replace excision, need not sew up, and has the analgesia, the hemostasis and reduce hemorrhage, response light, safe and can prevent advantages such as tumor diffusion, noticeable aspect oncotherapy, at present, it has been widely used in many medical domains such as oral cavity, skin, rectum, urinary system, gynecological, tumor, aspect such as neurosurgery and veterinary, for example all cutaneous tumor all can be treated by the way of freezing, and its five-year cure is between 90-98%; In addition,, can think that cryosurgery is just becoming the important method of the very strong bulk tumor of treatment Drug resistance also having reported some challenging results aspect the oncotherapy at some human body deeps such as positions such as lung, mammary gland, prostate and brain.Yet, the curative effect of low temperature therapy tumor aspect also is subjected to certain limitation at present, this is mainly because of due to the difficulty of freezing control aspect: on the one hand, need that certain length cryoprobe is inserted the human body deep tumor and implement treatment, thereby requirement insertion damage should be as far as possible little, meanwhile, must guarantee that also cryoprobe can be to not causing cold injury along the journey health tissues; On the other hand, the cooling of human body deep tumor is not if carry out the strict quality assurance, and is rare to satisfied treatment yet; And, for some tract tumor such as pulmonary carcinoma, the esophageal carcinoma, rectal cancer, nasopharyngeal carcinoma, carcinoma of prostate etc., the cryoprobe probe that requires to be inserted should have flexibility, slips into the wound that in the process tissue is caused to reduce the cryoprobe probe as small as possible naturally what enter tract (as respiratory tract, alveolar, esophagus etc.).In this respect, traditional cryoprobe be difficult to be realized above-mentioned target because knife bar is made of metal, generally can only be to the destructive puncture of harvesting of tissue, and in case the tube wall of above-mentioned tract by break-through after, the result who is caused is fatal often.So flexible cryoprobe is especially significant aspect the tract tumor treatment.And so far, almost be not suggested based on the cryoprobe of this conception of species.
Existing deep tumor treatment cryoprobe probe is based on the device form (hereinafter to be referred as Cooper-Lee type cryoprobe) of U.S. neurosurgeon I.Cooper in 1961 and A.S.Lee cooperation research and development mostly, its core is that the central passage by meticulous conduit is delivered to the cryoprobe head with liquid nitrogen and follows the ring passage and returns, outermost layer then is evacuated to reach heat insulation purpose, this structure can be sent to position to be treated with cold and can avoid to a certain extent cause cold injury along the journey health tissues, thereby its structure uses till today always, becomes one of topmost cold therapy device.Yet, this type of cryoprobe makes manufacturing process quite complicated because of the existence of vacuum structure, its heat-insulating property in fact be difficult to guarantee (because of vacuum volume too little), to such an extent as to can cause inevitably the low temperature cold injury along the journey health tissues, and cryoprobe need regularly be found time.In the recent period (Chinn, D.O. have the cryoprobe of thermal insulation and heating jacket, United States Patent (USP): No.5906612 to a United States Patent (USP) of report; Chinn; D.O.; Cryosurgical probe havinginsulating and heated sheaths; United States Patent:No.5906612) employing coating heating jacket on the cryoprobe outer wall reaches control cryoprobe head ice hockey size and cryoprobe is carried out the heat protection along the journey tissue; thereby improved the serviceability of cryoprobe; but this patent remains the improvement measure that proposes at traditional cryoprobe, can think do not have the scheme of flexible cryoprobe to be suggested so far always.
Summary of the invention
The objective of the invention is to: a kind of flexible cryoprobe probe that is used for the cold therapy of body cavities tumor that inserts mechanical damage that do not have is provided, its probe body is all made by flexible material except that cutter head, and probe body is divided into inside and outside two-layer concentric tubes, outer wall is provided with electrical heating elements, thereby can with cryogenic fluid when the body cavities of various complexity is transported to tumor locus to be treated, avoid being subjected to cold injury along the journey health tissues.
Technical scheme of the present invention is as follows:
The flexible cryoprobe probe that is used for the cold therapy of body cavities tumor provided by the invention, comprise: a flexible stylet main body, this flexible stylet main body comprises trocar sheath 1 and the inner sleeve 2 that the flexible material of concentric placement is manufactured, inner sleeve 2 be connected in order to liquid nitrogen bottle or the liquid helium bottle 9 that offers inner sleeve 2 freezing liquids, be covered with electrical heating elements 12 on the outer surface of trocar sheath 1, be covered with insulant 13 on the outer surface of electrical heating elements 12; The compartment of terrain is provided with temperature sensor 3 between electrical heating elements 12 and the insulant 13, and temperature sensor 3 wire of output terminal link to each other along drawing between electrical heating elements 12 and the insulant 13 with data acquisition unit 7 inputs, and data acquisition unit 7 connects computer 8; The outer surface of flexible stylet main body is provided with adiabatic sheath 5, and adiabatic sheath 5 is provided with the heat insulation bat-handle 6 of being convenient to medical worker's operation; The flexible cryoprobe probe that is used for the cold therapy of body cavities tumor provided by the invention comprises further that also one is positioned at flexible stylet main body freezing ferrule 4 foremost, and freezing ferrule 4 front end surface are circular arc spherical surface, filling porous tinsel 14 in it; The inner sleeve 2 of flexible stylet main body stretches into freezing ferrule 4 inner chambers, and the inner chamber of freezing ferrule 4 communicates with flexible stylet main body inner sleeve 2 and trocar sheath 1; Freezing ferrule 4 is provided with temperature sensor 3 foremost, and the wire of output terminal of temperature sensor 3 links to each other along drawing between electrical heating elements 12 and the insulant 13 with data acquisition unit 7 inputs, and data acquisition unit 7 connects computer 8; Described freezing ferrule 4 is done by the material copper or the aluminum of high heat conductance; Described freezing ferrule 4 is provided with groove with flexible stylet main body junction outer wall, and it goes up trocar sheath 1 suit of flexible stylet main body and freezing ferrule 4 links into an integrated entity; Described electrical heating elements 12 is controlled common metal resistance wire or a heating film of heating voltage; Be provided with electrical heating elements 10 in the described liquid nitrogen bottle 11; Described insulant 13 is a plastic tube; The diameter of described freezing ferrule 4 is the 2-20 millimeter; The surface of described freezing ferrule 4 is coated with silverskin; The resistance of described electrical heating elements 12 is 1-100 ohm, and voltage is 36 volts; The entire length of described flexible cryoprobe probe is 1-20 centimetre.
The flexible cryoprobe probe that is used for the cold therapy of body cavities tumor provided by the invention, kind, the depth and focus size according to tumor to be treated can be designed to different length, and electrical heating elements 12 power also can be adjusted in real time; The temperature sensor 3 that the certain position place is provided with on freezing ferrule 4 and the flexible stylet main body outer wall is in order to the relevant temperature in the monitor therapy process, and it can serve as and a kind ofly freezes or the monitor message of temperature-rise period in order to adjusting; This device core is that probe body is all made by flexible material, and is the concentric tubes structure, wherein, cryogenic fluid (as liquid nitrogen or liquid helium) can be transported to tumor locus to be treated along the inner sleeve 2 of inside, after heat exchange, liquid nitrogen undergoes phase transition becomes steam, returns along trocar sheath 1 more afterwards; Because the nitrogen vapor temperature of returning is still lower, very easily cause the cold injury of normal surrounding tissue, the present invention coats electrical heating elements 12 (electrical heating wire or electric heating film) in the flexible stylet main body apart from the first set a distance of cryoprobe place, exempt to guarantee the flexible stylet main body can generate heat when the transporting low temperature working medium in good time and to cause cold injury along the journey normal structure, and the good heat-insulating property of flexible material also helps the realization of this target inserting; In addition, electrical heating elements 12 (electrical heating wire or electric heating film) volume is less, thereby the probe body diameter can greatly reduce, thereby avoids inserting damage.And, owing to removed vacuum structure, the flexible stylet main body of cold therapy probe need not adopt the hard material of metal one class, and can make by flexible plastic etc., what realize thus is real flexible cryoprobe, it is very favourable aspect tract type tumor treatment, this is because probe can slide into tumor locus naturally along body cavities and treat, rigidity cryoprobe in the past then is difficult to accomplish this point, generally must be undertaken by puncture, thereby can before touching tumor, probe damage some normal structures even organ along journey, this is most important under some clinical settings, during as lung cancer therapy, if the impaired meeting of alveolar wall causes complication such as pneumothorax, have a strong impact on patients ' recovery, even serious consequence.
The present invention has overcome the processing technology of former Cooper-Lee type cryoprobe, the needing no vacuum structure, thereby made cryoprobe sizes is quite little, the mechanical damage degree that is caused is also just very low, this cryoprobe pipeline material is all made by flexible material, be traditional cryoprobe notion a kind of opened up wide, many cryoprobe structures that its thought is applicable to so far to be invented, thereby realize different flexible cryoprobes, significant for the cold therapy that promotes tract type tumor; The present invention is simple in structure, and cooling and cold injury protection are easy to realize particularly have unique flexibility function, are suitable for the body cavities oncotherapy at different sizes and position.
Description of drawings
Accompanying drawing 1 is a cryoprobe structural representation of the present invention;
Accompanying drawing 2 is the structural representation of flexible stylet main body;
Accompanying drawing 3 is the vertical profile sketch map of flexible stylet main body.
Accompanying drawing 4 is the structural representation of freezing ferrule;
Accompanying drawing 5 is the vertical profile sketch map of metal cryoprobe head;
Accompanying drawing 6 is the connection diagram of flexible stylet main body and freezing ferrule;
Wherein: 2 temperature sensors 3 of trocar sheath 1 inner sleeve
Freezing ferrule 4 adiabatic sheath 5 heat insulation bat-handles 6
Data acquisition unit 7 computers, 8 liquid nitrogen or liquid helium bottle 9
Electrical heating elements 10 liquid nitrogen or liquid helium 11 electrical heating elements 12
Insulant 13 tinsels 14
Embodiment
Further describe the present invention below in conjunction with the drawings and specific embodiments:
As seen from the figure, the flexible cryoprobe probe that is used for the cold therapy of body cavities tumor provided by the invention, comprise: a flexible stylet main body, this flexible stylet main body comprises trocar sheath 1 and the inner sleeve 2 that the flexible material of concentric placement is manufactured, inner sleeve 2 be connected in order to liquid nitrogen bottle or the liquid helium bottle 9 that offers inner sleeve 2 freezing liquids, be covered with electrical heating elements 12 on the outer surface of trocar sheath 1, be covered with insulant 13 on the outer surface of electrical heating elements 12; The compartment of terrain is provided with temperature sensor 3 between electrical heating elements 12 and the insulant 13, and the wire of output terminal of temperature sensor 3 links to each other along drawing between electrical heating elements 12 and the insulant 13 with the input of data acquisition unit 7, and data acquisition unit 7 connects computer 8; The outer surface of flexible stylet main body is provided with adiabatic sheath 5, and adiabatic sheath 5 is provided with the heat insulation bat-handle 6 of being convenient to medical worker's operation; The flexible cryoprobe probe that is used for the cold therapy of body cavities tumor provided by the invention comprises further that also one is positioned at flexible stylet main body freezing ferrule 4 foremost, and freezing ferrule 4 front end surface are circular arc spherical surface shape, filling porous tinsel 14 in it; The inner sleeve 2 of flexible stylet main body stretches into freezing ferrule 4 inner chambers, and freezing ferrule 4 inner chambers communicate with flexible stylet main body inner sleeve 2 and trocar sheath 1; Freezing ferrule 4 is provided with temperature sensor 3 foremost, and the wire of output terminal of temperature sensor 3 links to each other along drawing between electrical heating elements 12 and the insulant 13 with the input of data acquisition unit 7, and data acquisition unit 7 connects computer 8; Described freezing ferrule 4 is done by the material copper or the aluminum of high heat conductance; Described freezing ferrule 4 is provided with groove with flexible stylet main body junction outer wall, and it goes up trocar sheath 1 suit of flexible stylet main body and freezing ferrule 4 links into an integrated entity; Described electrical heating elements 12 is controlled common metal resistance wire or a heating film of heating voltage; Be provided with electrical heating elements 10 in the described liquid nitrogen bottle 11; Described insulant 13 is a plastic tube.
Fig. 1-5 provides core scheme of the present invention, and its flexible stylet main body is all made by flexible material such as plastics etc.; Freezing ferrule 4 diameters generally can be between 2mm-20mm, and entire length then can be in the 1-20cm scope; Cryogenic fluid (as liquid nitrogen or liquid helium) can be transported to tumor locus to be treated along inner sleeve 2, and after heat exchange, liquid nitrogen undergoes phase transition and becomes steam, returns along trocar sheath 1 more afterwards; Cause tissue is on the way caused cold injury for preventing to return cryogenic nitrogen steam, the present invention has the electrical heating elements 12 (resistive heater or heating film) of certain power in the coating of span probe a distance outside the flexible stylet main body, when being resistive heater, can be on the trocar sheath 1 of flexible stylet main body with resistance wire, the also heating film of purchasing on the available markets, with heating element heater 12 is one or more groups, can change the voltage swing of electrical heating elements 12 as required and realize different heating process, because heater strip is near tissue, in case energized, heat will produce rapidly, thereby can avoid the interior liquid nitrogen steam cold of probe that tissue is damaged preferably; Heating element heater 12 peripheries are coated with insulant 13, with further reinforcement to frosted protective action and prevent the electric leakage human body is damaged, heater strip adopts materials such as Ni-Cr alloy, and this type of integrated heating element heater 12 is buied on market easily, only needs to be selected to get final product according to power demand.In addition, for further guaranteeing safety, heating voltage generally should lie prostrate scope at 1-36, and heating wire resistance can be chosen between 1-100 ohm, thus obtained heating power satisfies the needs avoid cold to reach tissue fully, even and it leaks electricity, can not damage human body yet.Moreover the safety and the reliability of this therapy equipment further guaranteed in the use of insulant 13.In sum, owing to adopt heating element heater 12 protection cold injury, can exempt the making of vacuum heat-insulating layer, thereby probe size is less, and probe body just can adopt also flexible material to make, the cryoprobe of Shi Xianing is real flexible cryoprobe thus.The proposition that the cryoprobe bar is designed to flexible this notion will promote tract tumor cold therapy Progress in technique.
Described freezing ferrule 4 front ends are processed with the groove (see figure 6), so that, see Fig. 6 with flexible stylet main body trocar sheath 1 suit thereon, for guaranteeing to connect reliably between the two, can tighten bonding jumper at groove; Freezing ferrule 4 inside are hollow, and are filled with tinsel 14 to strengthen the liquid nitrogen heat exchange, and it is inner that flexible stylet main body inner sleeve 2 stretches into freezing head, thereby cryogenic fluid is carried enforcement cooling herein; Because cold therapy is by the conduction of heat at cutter head place touching position to be lowered the temperature rapidly to freeze, so, be to improve cooling-down effect, freezing ferrule 4 should be selected the higher metal of thermal conductivity such as copper, aluminum or silver etc.; In addition, freezing head surface can plate silverskin etc., contacts and toxigenicity with tissue with the flexible stylet main body of avoiding some kind; Freezing ferrule 4 can make different sizes and shape as required, but is generally the circular arc spherical surface shape.
For ease of operation in the operation, the present invention is coated with adiabatic sheath 5 in the flexible stylet main body, and has heat insulation bat-handle 6 on it, and the two can be made by timber or plastics etc., can avoid cold or heat in the cryoprobe to reach doctor's hand thus, and therefore operation is safe.
The temperature sensor 3 (as thermocouple) of this device is welded on some selected positions and freezing ferrule 4 ends on the flexible stylet main body, thereby freeze or resistance wire heating process with its temperature regime control tumor cooling of The real time measure, the wire harness of temperature sensor 3 (as thermocouple) is then along drawing in the intravital hollow of the flexible stylet master duct, and the signal input part of connection data acquisition unit 7, and data acquisition unit 7 connects on the computers 8; Like this, the temperature signal that is collected just transfers in the computer 8, whether changes the heating voltage size by the control sequence decision of being worked out; According to measured flexible stylet main body outside wall temperature, adjust heating voltage, so that the quantity of heat given up of different sizes to be provided, finish different treatment procedures.According to tumor kind to be treated, the position depth and focus size, the invention provides device and can be designed to different length and shape.
In sum, heat sink provided by the present invention does not have labyrinth, is easy to realize, data acquisition and processing are convenient, relatively are suitable for the cold therapy of tract tumor.
When implementing oncotherapy, follow certain therapeutic scheme; As at deep digestive tract tumor, can determine patient's tumor position and area size by CT, under ultrasonic guidance, one piece of device of the present invention is slipped into this tumor locus along digestive tract to be implemented to freeze, the temperature information that monitors according to data acquisition unit 7 and computer 8 simultaneously, adjust heater circuit, digestive tract wall normal structure is subjected to cold injury to avoid on the way.This operation can be inserted into position to be treated exactly with cryoprobe under ultrasonic or other medical device guide, can avoid big operation process, is one of preferable therapeutic scheme.For tract tumor treatment such as nasopharyngeal carcinoma, rectal cancer, also can adopt similar above-mentioned program to carry out.The most important of the present invention is a notion of having introduced flexible stylet, make complex-shaped tract oncotherapy become safety and make things convenient for.

Claims (8)

1, a kind of flexible cryoprobe probe that is used for the cold therapy of body cavities tumor, comprise: a flexible stylet main body, this flexible stylet main body comprises trocar sheath (1) and the inner sleeve (2) that the flexible material of concentric placement is manufactured, inner sleeve (2) be connected in order to liquid nitrogen bottle or the liquid helium bottle (9) that offers inner sleeve (2) freezing liquid, be covered with electrical heating elements (12) on the outer surface of trocar sheath (1), be covered with insulant (13) on the outer surface of electrical heating elements (12); The compartment of terrain is provided with temperature sensor (3) between electrical heating elements (12) and the insulant (13), the wire of output terminal of temperature sensor (3) links to each other along drawing between electrical heating elements (12) and the insulant (13) with the input of data acquisition unit (7), and data acquisition unit (7) connects computer (8); The outer surface of flexible stylet main body is provided with adiabatic sheath (5); Comprise further that also one is positioned at flexible stylet main body freezing ferrule (4) foremost, freezing ferrule (4) front end surface is a circular arc spherical surface shape, filling porous tinsel (14) in it; The inner sleeve of flexible stylet main body (2) stretches into freezing ferrule (4) inner chamber, and freezing ferrule (4) inner chamber communicates with flexible stylet main body inner sleeve (2) and trocar sheath (1); Freezing ferrule (4) is provided with temperature sensor (3) foremost, the wire of output terminal of temperature sensor (3) links to each other along drawing between electrical heating elements (12) and the insulant (13) with the input of data acquisition unit (7), and data acquisition unit (7) connects computer (8).
By the described flexible cryoprobe probe that is used for the cold therapy of body cavities tumor of claim 1, it is characterized in that 2, described adiabatic sheath (5) is provided with the heat insulation bat-handle (6) of being convenient to medical worker's operation.
3. by the described flexible cryoprobe probe that is used for the cold therapy of body cavities tumor of claim 1, it is characterized in that described freezing ferrule (4) is done by the material copper or the aluminum of high heat conductance.
4. by the described flexible cryoprobe probe that is used for the cold therapy of body cavities tumor of claim 1, it is characterized in that, described freezing ferrule (4) and flexible stylet main body junction outer wall are provided with groove, and it goes up the trocar sheath of flexible stylet main body (1) suit and freezing ferrule (4) links into an integrated entity.
5. by the described flexible cryoprobe probe that is used for the cold therapy of body cavities tumor of claim 1, it is characterized in that described electrical heating elements (12) is controlled common metal resistance wire or a heating film of heating voltage.
6. by the described flexible cryoprobe probe that is used for the cold therapy of body cavities tumor of claim 1, it is characterized in that, be provided with electrical heating elements (10) in the described liquid nitrogen bottle (9).
7. by the described flexible cryoprobe probe that is used for the cold therapy of body cavities tumor of claim 1, it is characterized in that described insulant (13) is a plastic tube.
8. by the described flexible cryoprobe probe that is used for the cold therapy of body cavities tumor of claim 1, it is characterized in that the diameter of described freezing ferrule (4) is the 2-20 millimeter.
CNB021042462A 2002-02-25 2002-02-25 Flexible cold knife probe for human body cavity tumor cryotherapy Expired - Lifetime CN1214766C (en)

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US20150126987A1 (en) * 2012-01-26 2015-05-07 Vyacheslav Yuryevich Semenov Method for feeding a cryogenic agent to a cryogenic instrument and cryosurgical apparatus for implementing same
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US10610279B2 (en) * 2014-04-10 2020-04-07 Channel Medsystems, Inc. Apparatus and methods for regulating cryogenic treatment
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CN106725825B (en) * 2017-01-10 2019-09-27 重庆大学 The minimally invasive cryoprobe system of high pressure gas expansion refrigeration
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