Summary of the invention
It is a kind of from keeping the cold and hot knife system of the integrated oncotherapy of type that this utility model purpose is to provide, it can produce cryogenic fluid (as liquid nitrogen) and high temperature refrigerant voluntarily, thereby can freeze and heat up to melt requirement in the cooling that need not the external world and provide to satisfy under the situation of cryogenic fluid cold and hot cutter, realize the oncotherapy purpose.
The technical solution of the utility model is as follows:
The cold and hot knife system of the integrated oncotherapy of the type of keeping certainly that this utility model provides, as depicted in figs. 1 and 2, it comprises: cryogenic fluid container 10, probe tube 2, probe 3, computer and display; It is characterized in that, also comprise: the cryogenic refrigerating unit 66, high temperature refrigerant generator 1, cryogenic liquid working medium container 10 and the cabinet 68 that are used to produce cryogenic fluid;
Described cryogenic refrigerating unit 66 is connected with described cryogenic fluid container 10 by the first insulation connecting leg 77; Described cryogenic refrigerating unit 66 is by implementing liquefaction and separate to air, the cryogenic fluid (as liquid nitrogen) that the produces force feed mechanism by cryogenic refrigerating unit 66 inside is injected in the cryogenic fluid container 10 store, and cooling was used when cooling froze treatment; Described cryogenic fluid container 10 is fixed on described cabinet 68 1 side box walls by the second insulation connecting leg 88 and low-temperature solenoid valve 6; Described high temperature refrigerant generator 1 is fixed on described cabinet 68 1 side box walls by the 3rd insulation connecting leg 99 and high-temperature solenoid valve 61, be communicated in the insulation of being located within the described cabinet 68 after converging afterwards again and be total on the connecting leg 4, described insulation connecting leg 4 altogether is fixed on the described cabinet 68 opposite side tank walls by metal fixed mount 33; By opening, closing high-temperature solenoid valve 61 and low-temperature solenoid valve 6, can make high temperature fluid working medium or cryogen working medium be total to connecting leg 4 and be transported to probe 3 through probe tube 2 along insulation, thereby in these probe 3 realization cooling or intensifications rapidly;
The tape spool that extremely before is arranged in order after described probe tube 2 is served as reasons is to the annular tract 25 of centre bore and the integrative-structure of circular probe tube body 27 formations; Circular probe tube body 27 front ends are provided with screw thread, its axial centre is provided with circle and comes circulation road 24, circle is come circulation road 24 to establish successively with circle outside axially and is come circulation road 24 annular return flow line 23 concentric and that communicate with annular tract 25 and annular vacuum chambers 21, and described circle comes circulation road 24 to be connected with the axial center hole of described annular tract 25; Described circular probe tube body 27 tube walls are provided with the vacuum orifice 22 that communicates with annular vacuum chamber 21; Probe tube 2 rear portions are total to connecting leg 4 by rustless steel ripple connection tube 11 and insulation successively and are connected with high-temperature generator 1 and cryogenic fluid container 10; Probe tube 2 front threads linking probe heads 3, probe 3 is served as reasons the back to the annular backward channel 34 that before is arranged in order and the integrative-structure of probe precursor 35, probe precursor 35 front ends are circle or arc, the axial centre of probe 3 establish with circular probe tube body 27 in the circle circular probe head that comes circulation road 24 to communicate come circulation road 31; Probe precursor 35 is hollow cavity, is filled with Web materials 33 in it, and probe 3 is the metal probe head; Described computer and display thereof are arranged on described cabinet 68 top surfaces.
Described cryogenic refrigerating unit 66 is reined in the combination of Mil's circulating refrigerating device, Ji Fute-McMahon circulating refrigerating device, Sol literary composition circulating refrigerating device, Brayton cycle refrigerating plant, pulse tube circulating refrigerating device, adiabatic demagnetization circulating refrigerating device, solid coolant device or above-mentioned refrigerating plant for Joule-Thomson circulating with choke refrigerating plant, Stirling circulating refrigerating device, dimension.
The cryogenic fluid that described cryogenic refrigerating unit is made is liquid nitrogen, liquid helium, liquid neon, liquid CO
2, liquid hydrogen or its combination.
The high temperature refrigerant that described high temperature refrigerant generator 1 produces is in a liquid state at normal temperatures, gaseous state or solid-state; Described high temperature refrigerant temperature is not less than 50 ℃.
Described cryogenic fluid container 10 is a cryogenic Dewar bottle, and heating arrangements is set in it; Heating or combustion mechanism are set in the described high temperature refrigerant generator 1.
Of the present utility model from keeping the cold and hot knife system of the integrated oncotherapy of type, also comprise a probe handle 42 and an insulating connector 41, establish axial center hole in the insulating connector 41, described insulation connecting leg 4 passes this centre bore and is connected with rustless steel ripple connection tube 11.
Described high temperature refrigerant generator 1 is laser instrument, microwave generator or radio-frequency signal generator.
Described cryogenic fluid container 10 and high temperature refrigerant generator 1 all are provided with 1-30 output channel branch, connect by the pipeline between the output channel branch, form 1-30 delivery outlet, this 1-30 delivery outlet is connected with 1-30 piece respectively in order to implement the probe tube and the probe of oncotherapy.
Described high temperature refrigerant generator 1 and cryogenic liquid working medium container 10 place described cabinet 68 inside or the outside.
Described probe tube 2 and probe 3 external diameters should as far as possible little (one be lower than 8mm) so that this utility model reaches Wicresoft.
It is of the present utility model that keeping the type oncotherapy can also increase a probe handle 42 and an insulating connector 41 with cold and hot cutter integrated apparatus certainly, establish axial center hole in the insulating connector 41, insulation connecting leg 4 passes this centre bore and is connected with rustless steel ripple connection tube 11.
Probe tube 2 and probe 3 structures as shown in Figure 2, probe tube 2 outermost layer annular vacuum chambers 21 are evacuated, purpose is for the heat transfer between high cryogen in the isolated as far as possible pipe and tube wall surrounding health tissue, thereby avoids scald or cold injury tissue; Probe tube 2 central circular are come circulation road 24, and cryogenic fluid or high temperature refrigerant fluid circle thus come circulation road 24 to flow to probe 3; Evacuated outermost layer annular vacuum chamber 21 becomes for cryogenic fluid liquid released cold quantities and returns after steam or high temperature refrigerant release heat become liquid; Because in the outermost layer annular vacuum chamber 21 is vacuum, liquid heat that returns or cold are unlikely to pass to outer wall significantly, thereby the probe insertion organizes the heat or the cold damage that are subjected to minimum on the way; Probe tube comprises that (circle is come circulation road 24 for annular vacuum chamber 21, annular return flow line 23 for container chamber 25 and three donut tracts before thereof; Circle comes circulation road 24 to be connected by insulation connecting leg 4 and rustless steel ripple connection tube 11 with high temperature refrigerant generator 1 that is provided with high-temperature solenoid valve 61 and the cryogenic fluid container 10 that is provided with low-temperature solenoid valve 6 simultaneously, can provide corresponding cryogenic fluid or high temperature refrigerant according to the requirement of treatment procedure thus.The fluid that container chamber 25 returns in order to storage, this fluid also can directly be discharged into the external world from here.The circle of probe tube comes circulation road 24, annular return flow line 23 to come circulation road 31 and netted heat-barrier material 33 to be communicated with probe 3 central circular probes respectively; Connect by internal and external threads between probe tube 2 and the probe 3, also can be weldingly fixed on together; Probe 3 comes circulation road 31 and netted heat-barrier material 33 on every side thereof to form by being positioned at the central circular probe; The probe outer wall is selected high heat conductivity metal, so that with tumor to be treated heat exchange preferably takes place, thereby improves thermotherapy effect; Circular probe head in the probe comes circulation road 31 to have fine voids (entrance is then for solid) at the certain position of distance inlet wall, after entering probe, the working medium of probe tube 2 can penetrate into netted heat-barrier material 33 on every side along these spaces, and undergo phase transition heat exchange, (for cryogenic fluid is released cold quantity to emit a large amount of colds or heat, for high temperature refrigerant then is release heat), because probe 3 has good heat exchange with surrounding tissue, but a large amount of colds or heat moment directly act on tumor tissues, thereby reach the purpose of rapid destroyed tumor; Thus, the high temperature refrigerant that cryogenic fluid that the integrated oncotherapy of the type of keeping certainly that this utility model provides can provide by cryogenic refrigeration equipment 66 with cold and hot knife system and high temperature refrigerant generator 1 produce, high-intensity cold and heat are transferred to the deep tumor place, reach the purpose of killing tumor cell.The probe head can be provided with thermocouple to measure the temperature of tumor locus in the therapeutic process, and it can serve as a kind of monitor message.
Of the present utility model have following advantage from keeping the integrated oncotherapy of type with cold and hot knife system:
Because required cryogenic fluid and the high temperature refrigerant of this utility model, realize by cryogenic refrigerating unit that self was equipped with and high temperature refrigerant generator, thereby use more conveniently, not limit by the region, be easy to apply, can satisfy the demand of the growing cold and hot treatment of tumor patient.
The specific embodiment
Further describe this utility model below in conjunction with the drawings and specific embodiments:
Embodiment 1:
As shown in Figure 1, the cold and hot knife system of the integrated oncotherapy of the type of keeping certainly that this utility model provides comprises: cryogenic refrigerating unit 66, high temperature refrigerant generator 1, cryogenic fluid container (liquid nitrogen container) 10, probe tube 2, computer 100 and the probe 3 etc. that are used to produce cryogenic fluid such as liquid nitrogen; Wherein: cryogenic refrigerating unit 66 is connected by insulation connecting leg 77 with cryogenic fluid container 10, like this, cryogenic refrigerating unit 66 can be by implementing liquefaction, separating to air, and the cryogenic fluid of generation some such as liquid nitrogen etc., the liquid nitrogen that is generated is injected in the cryogenic fluid container 10 by the cryogenic refrigerating unit 66 inner force feed mechanisms that are provided with and stores, and cooling was used when cooling froze treatment; High temperature refrigerant generator 1 and cryogenic fluid container 10 can place cabinet 68 inside, also can be shelved on cabinet 68 outsides; High temperature refrigerant generator 1 and cryogenic liquid working medium container 10 are respectively by insulation connecting leg (88,99) and electromagnetic valve (61,6) be fixed on cabinet 68 shells one sidewall, be connected to after converging afterwards on the insulation connecting leg 4, insulation connecting leg 4 is fixed on another sidewall of casing by metal fixed mount 33; By opening, closing high-temperature solenoid valve 61 or low-temperature solenoid valve 6, can make high temperature refrigerant or cryogenic fluid be transported to end of probe 3 along insulation connecting leg 4, thereby in this end of probe realization cooling or intensification rapidly; Used computer of the present invention and display 100 thereof are arranged on cabinet 68 tops;
In this utility model, the cryogenic refrigerating unit 66 that is used to obtain cryogenic fluid is by to producing the cryogenic fluid liquid nitrogen after the air liquefaction, and its technology path is sophisticated, but thereby self manufacture or directly buy from market obtain; High temperature refrigerant generator 1 can be bought, and also can be made by conventional method, as resistive heater is set in canister, can pass through heating liquid water generates high temperature refrigerant steam; And cryogenic fluid container 10 has the standardized product of different series, chooses from the market to get final product; The tape spool that extremely before is arranged in order after probe tube 2 is served as reasons is to the annular tract 25 of centre bore and the integrative-structure of circular probe tube body 27 formations; Circular probe tube body 27 front ends are provided with screw thread, circular probe tube body 27 axial centre are provided with circle and come circulation road 24, circle is come circulation road 24 to establish successively with circle outside axially and is come circulation road 24 annular return flow line 23 concentric and that communicate with annular tract 25 and annular vacuum chambers 21, and described circle comes circulation road 24 to be connected with the axial center hole of described annular tract 25; Described circular probe tube body 27 tube walls are provided with the vacuum orifice 22 that communicates with annular vacuum chamber 21; Probe tube 2 rear portions are connected with high-temperature generator 1 and cryogenic fluid container 10 by being incubated common connecting leg 4; Probe tube 2 front threads linking probe heads 3, probe 3 is served as reasons the back to the annular backward channel 34 that before is arranged in order and the integrative-structure of probe precursor 35, probe precursor 35 front ends are circle or arc, the axial centre of probe 3 establish with circular probe tube body 27 in the circle circular probe head center of coming circulation road 24 to communicate come circulation road 31; Probe precursor 35 is hollow cavity, is filled with Web materials 33 in it, and probe 3 is the metal probe head; The probe outer wall is selected with metal material such as copper or rustless steel.
Probe tube 2 outermost annular vacuum chambers 21 are evacuated, and with the heat transfer between high cryogenic fluid and tube wall surrounding health tissue in the isolated as far as possible pipe, thereby avoid burning or the cold injury health tissues; Probe tube central circular passage 24, high cryogenic fluid flows to its working position--probe thus.Coming the passage between circulation road 24 and the outside annular vacuum chamber 21 in the probe tube central circular is annular return flow line 23, this annular return flow line 23 is returned behind probe 3 release heat or cold for high cryogenic fluid, also come the working medium of circulation road 24 to form a kind of heat protection thus to circle, to avoid the significantly variation of incoming flow working medium temperature, and be annular vacuum chamber 21 because of exocoel simultaneously, the unlikely outer wall that passes to of the heat of high cryogenic fluid or cold; The circle of probe tube 2 comes circulation road 24 to be communicated with high temperature refrigerant generator 1 (steam generator) or cryogenic fluid container 10 (liquid nitrogen container), the working medium that annular tract 25 returns in order to storage, and its inner fluid is reusable, also can discharge on the spot; Probe tube 2 and probe 3 can be with being threaded or welding together;
It is of the present utility model that keeping the type oncotherapy can also increase a probe handle 42 and an insulating connector 41 with cold and hot cutter integrated apparatus certainly, establish axial center hole in the insulating connector 41, insulation connecting leg 4 passes this centre bore and is connected with rustless steel ripple connection tube 11.
For the cryogenic fluid fluid, initial temperature all can be selected for use near the fluid the absolute zero at subzero 10 ℃ in principle, except that liquid nitrogen, also can be liquid helium, liquid oxygen, liquid air (combination of liquid nitrogen and liquid oxygen), also can be liquid N
2O, liquid CO
2Deng; Aforesaid liquid working medium can be gaseous state; When they are in a liquid state or during gaseous state, the cooling-down effect difference that is realized, thus satisfy different medical need; In addition, above-mentioned all kinds of working medium also can be mixed use according to a certain ratio, such as liquid nitrogen, liquid oxygen and the liquid N of different component
2O is mixed etc.;
Above working medium (cryogenic fluid and high temperature refrigerant) is gaseous state at normal temperatures, through becoming liquid behind the cryogenic liquefaction in advance, and be stored in the cryogenic fluid container 10, when probe 3 (cold and hot jet blade) needs cooling, by pressure the cryogenic fluid of above-mentioned cryogenic fluid container 10 is transported to probe 3 (cold and hot jet blade) through probe tube 2, reach the cooling purpose by released cold quantity to surrounding tissue, return and put by the return flow line afterwards to atmosphere;
For the high temperature refrigerant fluid, can realize in principle initial temperature fluidic working medium more than 50 ℃ all can, such working medium dewater or water vapour outside, also comprise avirulence, free of contamination other high temperature fluids; These high temperature fluids are liquid at normal temperatures, also can be gaseous state or solid-state, such as the high-temperature gas that produces by burning in elevated temperature vessel 1 when leading to the probe tube head, also can realize quickish heating, this part high-temperature medium comprises: as be stored in fuel gas in the high temperature refrigerant container (with environmental friendliness be good) as acetylene after burning, generate by high-temperature water vapor and high temperature CO
2The gas that mixes also can be realized quick and strong heat effect at cutter head, thereby causes the high temperature of tumor tissues that probe touches to be killed.In addition, in high temperature refrigerant generator 1,, make solid kind fuel (as wooden carbon), or liquid type fuel (as oil) waits burning generation high temperature CO by the rich long-pending oxygen of supply
2Gas also can be realized the rapid intensification of tumor locus; In addition, high temperature refrigerant generator 1 also can adopt replacements such as laser instrument, microwave generator or radio-frequency signal generator, thus along the energy that is arranged at the passages output various ways in the probe 2, and is transferred to probe 3 and sentences and implement to heat to treat;
Cryogenic fluid that this utility model provides or high temperature refrigerant and as Fig. 1, device shown in 2 is used, when using the different solutions proportioning or adopting different working medium, can realize cooling, the intensification effect of relative broad range, it is easy to obtain, cost is low, thereby can reduce cold and hot cutter operating cost greatly, and reach better therapeutic effect.
Of the present utility model from keeping the cold and hot knife system of the integrated oncotherapy of type, the probe precursor 35 of its probe 3 is hollow cavity, be filled with netted heat-barrier material 33 in it, probe precursor 35 is selected high heat conductivity metal (as copper or rustless steel) for use, so that heat exchange preferably takes place, thereby improve therapeutic effect with tumor tissues to be treated; Circular probe heads in the probe 3 come to have fine voids on circulation road 31 one section channel wall forward, netted heat-barrier material 33 around can penetrate into along these spaces after the working medium of probe tube 2 enters probe 3, this moment, working medium underwent phase transition heat exchange, emit a large amount of heats or cold, because probe 3 has good heat exchange with surrounding tissue, a large amount of heats or cold directly act on tumor tissues, thereby reach a high temperature or low temperature is killed the purpose of tumor; Fluid in the netted heat-barrier material 33 that probe 3 is loaded after heat release or heat absorption returns along the annular return flow line 23 of probe tube 2; Thus, of the present utility modelly heat or cold can be transferred in the body deep tumor place or tract (as positions such as digestive tract, rectum) necessarily with the lossless manner of minimum with cold and hot knife system, reach the purpose of destroyed tumor tissue from keeping the integrated oncotherapy of type; The head of probe 3 can be circle or arcuation, in order to entering deep tissue, avoiding scratching along the journey tissue, and the diameter of probe tube 2 and probe 3 one should as far as possible little (as being lower than 8mm), so that reduce mechanical damage when being punctured in the human body as far as possible to tissue, probe tube 2 and probe 3 can be made into the counterpart of different length, therefore, the present invention is applicable to different depth, different size tumor thermotherapy usefulness; Probe 3 tops also can be provided with thermocouple to measure the temperature of tumor locus in the therapeutic process, so that the treatment of device is monitored;
The cryogenic fluid that is generated by cryogenic refrigerating unit 66 is contained in the cryogenic fluid container (Dewar flask) 10, the resistance heating wire is housed in the Dewar flask, once energising, can heat cryogenic fluid, make it progressively to vaporize, because gas expansion makes the increased pressure in the whole Dewar flask confined space, when pressure arrives certain value, just open low-temperature solenoid valve 6, liquid nitrogen in the Dewar flask is sent to the corrugated conduit 11 that communicates with Dewar flask, enter probe tube 2 subsequently; The driving of liquid nitrogen also can be adopted and sophisticatedly realize from boosting mode in this Dewar flask.
High temperature refrigerant outlet and cryogenic fluid outlet are connected with utilidor 4 by high-temperature solenoid valve 61 and low-temperature solenoid valve 6 respectively, in case close electromagnetic valve, can stop transferring working medium; After opening Subzero valve 6, then the cryogenic fluid of Dewar flask output leads to syringe needle 3 along probe tube 2, the sharp freezing that can organize; High temperature refrigerant is then produced by generator, so opening high-temperature solenoid valve 61 and feeding high temperature refrigerant or during energy, what then exercised is the high temperature thermotherapy, probe 3 is provided with temperature sensor (as thermocouple), and be connected to the input of data collecting instrument, and data collecting instrument is communicated with computer 100, during the treatment beginning, open data collecting instrument and computer, can monitor each point for measuring temperature temperature; Certainly, temperature sensor also can be attached to the temperature-responsive of probe outer surface with monitoring skin; Store certain high low temperature therapy (promptly lower the temperature and heat up) program in the computer, for selecting for use.
It is of the present utility model that keeping the integrated oncotherapy of type can implement cryosurgery separately with cold and hot knife system certainly, also can carry out the high temperature thermotherapy separately, can also be that the two therapeutic combination hockets, and switching between low temperature and high temperature refrigerant and retention time can arbitrarily be adjusted, and promptly realize different freezing or thermotherapy effects thus.Promptly finish treatment after closing all electromagnetic valves;
Of the present utility model keeping the integrated oncotherapy of type all can be provided with alarm with cold and hot knife system in Dewar flask and steam generator certainly, specifically can adopt buzzer to serve as alarm device, when container internal pressure is too high, is pointed out.
Embodiment 2:
Present embodiment is that with embodiment 1 unique different place the fluid of main frame output is not only the single cold-hot probe of supply, and many pieces of probes such as 2-30 root probe in fact also can be provided as required, so that be used for simultaneously the cold and hot treatment of bulk tumor tissues is used.What accompanying drawing 3 provided is the structural representation that this utility model is used to drive 3 pieces of probe tubes and probe.Here, on the runner of pipeline after valve from cryogenic fluid container 10 or high temperature refrigerant generator 1, can branch into three runners separately, like this, between three low temperature runners and the high temperature runner, can be connected respectively together again, form three high low temperature outfans thus, be fixed in cabinet 68 outsides; So, when cold-hot probe inserts these corresponding delivery outlets, can under handling, computer open or close the electromagnetic valve on each runner respectively, carry out corresponding cold and hot therapeutic scheme thus.Different therewith is, can only finish the support to single cold-hot probe among the embodiment 1, and present embodiment then provides multiprobe cold and hot therapeutic scheme, uses more flexible.Remaining part is then identical with embodiment 1, no longer is repeated in this description herein.
From the above mentioned, high temperature refrigerant of the present utility model or cryogenic fluid provide by equipment of itself, need not purchase in advance, thereby very convenient to use.These features all make the promotion prospect that the utlity model has relative broad range.
The tumor therapeutic procedure that uses this utility model to realize is as follows:
(1) before the clinical cryosurgery treatment of enforcement, estimate required cryogenic fluid such as liquid nitrogen population size, prepare enough liquid nitrogen by cryogenic refrigerating unit 66 in advance, and be stored in the cryogenic fluid container 10 standby according to the size of focus tumor;
When (2) treating, open heater circuit or burner in cryogenic fluid container 10 and the high temperature refrigerant generator 1, carry out the pressurization of working medium;
(3) select required number of probes, connect in cabinet 68; Under ultrasonic guidance, every piece of probe 3 is inserted position to be treated, open cryogenic fluid electric valve 6, then cryogenic fluid will flow to probe 3 (also being tumor locus to be treated), because the evaporation heat absorption takes place in the cryogenic fluid liquid at probe 3, a large amount of colds is supplied to tissue by moment, so can rapidly tumor tissues be freezed and be destroyed, and along the protective effect of journey owing to vacuum passage, health tissues is not subjected to very big cooling effect, afterwards, the cryogenic fluid steam of generation returns along the return flow line; When tumor tissues is frozen into to a certain degree, close the cryogenic fluid valve; And open the electromagnetic valve 61 of high temperature refrigerant generator 1 rapidly, established a large amount of steam will flow to position to be treated this moment, and at end of probe generation condensation heat transfer, moment is emitted a large amount of heats, tissue was heated owing to moment, take place to expand suddenly, burst, aggravate killing and wounding then greatly tumor thereby can cause.
Core of the present utility model has been to realize to keep certainly the cold and hot cutter treatment of type, thereby can finish the cold and hot treatment of corresponding tumor anywhere; This utility model can be easily by high cryogenic fluid alternately transport realization significantly and cold and hot fast amount discharge and reach the heating and cooling process that changes deep tumor, cooling and intensification degree are very remarkable.And population structure is compact simple, and temperature regulating range is wide.
By appropriate design, cryogenic refrigerating unit 66 of the present utility model (small-sized) can be used for obtaining multiple cryogenic fluid, as liquid helium, liquid oxygen, liquid air (combination of liquid nitrogen and liquid oxygen), or the chemical compound of above-mentioned medium such as liquid N
2O or liquid CO
2Deng, and other NM herein cryogen working medium.During treatment, by changing operation working medium and parameter thereof, then the temperature in the tumor tissues promptly changes thereupon, response speed is fast, seriality is good, can realize complicated cooling and heating schedule, be suitable for each large, medium and small type hospital and use, significant for the progress that promotes the low-temperature biological Medical Technology.The most significant characteristics of this utility model are, the general medical science unit of any region and research institution all can purchase use, and this makes it be easy to promote and can produce society and economic benefit widely.
It should be noted that at last above embodiment is only unrestricted in order to the explanation the technical solution of the utility model.Although this utility model is had been described in detail with reference to embodiment, those of ordinary skill in the art is to be understood that, the technical solution of the utility model is made amendment or is equal to replacement, the spirit and scope that do not break away from technical solutions of the utility model, it all should be encompassed in the middle of the claim scope of the present utility model.