TWI844468B - Fixing structure for fluid conduit and soft tissue phantom - Google Patents

Abstract

A fixing structure for a fluid conduit and a soft tissue phantom is disclosed. The fixing structure includes a first package part and a second package part. The first package part is configured for individually packaging a soft tissue phantom, which includes at least an inlet end and at least an outlet end. The second package part is configured for individually packaging a fluid conduit unit, which includes a flow-in duct and a flow-out duct, wherein two ends of the flow-in duct are respectively detachably connected to a pressure device and the inlet end, and two ends of the flow-out duct are respectively detachably connected to the outlet end and the pressure device, so that the soft tissue phantom and the fluid conduit unit are connected to each other. By packaging the soft tissue phantom and the fluid conduit unit separately within their respective package parts, it is easy to assemble, move, replace, and fix the soft tissue phantom and the fluid conduit unit; furthermore, this also enhances the visibility of various components of the fluid conduit unit and a digital display device.

Description

Fixation structure of fluid conduit and soft tissue prosthesis

The present invention relates to a fixing structure of a fluid pipeline and a soft tissue prosthesis, and in particular to a structure that uses different packaging parts to package the fluid pipeline and the soft tissue prosthesis respectively, so that the soft tissue prosthesis and the fluid pipeline unit are easy to assemble, move, replace and fix, and are not easy to deform, and the digital display is easy to observe.

After converting human body CT images into three-dimensional images, soft tissue prostheses such as liver prostheses, heart prostheses, and digestive tract prostheses are manufactured based on the three-dimensional images. Since the shapes are completely consistent with real organs and the hardness can be controlled to be the same as real organs, they can be provided to doctors as consumables for practicing surgery. This type of soft tissue prosthesis is soft, and the currently known packaging method is to use a film to seal it in a vacuum manner, and then remove the film when needed. This type of prosthesis has the following disadvantages:

1. In order for a soft tissue prosthesis to simulate fluid pressure such as blood pressure, it is usually necessary to connect external tubes and pumps to the soft tissue prosthesis. However, the current external tubes and pumps lack packaged as a set and are often assembled in a splicing manner. This is not only not conducive to the replacement of the soft tissue prosthesis, but also because the external tubes and pumps are too scattered and easily missed or lost, and are not conducive to collection and transportation.

2. The soft tissue prosthesis is wrapped in a plastic film, and the whole body is still soft. It may be squeezed and damaged by accidental collision during the process of moving, transporting and taking.

3. Soft tissue prostheses are not easy to fix. For example, if a liver prosthesis is placed directly on a platform for operation, the liver prosthesis will not be able to maintain its original shape due to its softness and lose its fidelity, resulting in poor surgical practice results.

Chinese invention patent publication number CN103268726B discloses an ultrasound-guided needle puncture surgery analog training system, including a cylinder, an infrared laser, a puncture needle, a handle, a double-axis two-ring frame, a connecting rod arm, a base with rollers, an ultrasound probe model, a prosthesis model, a six-degree-of-freedom magnetic locator, two magnetic locator sensors, a computer and a cylinder control unit; the handle is controlled by the user to push or pull back, the laser direction of the infrared laser points to the puncture surface target of the puncture needle, the pressure sensor is used to measure the pressure in the cylinder, and the displacement sensor is used to measure the displacement of the cylinder piston rod. The signals of the two enter the computer through the controller, and the controller controls the proportional valve outlet pressure according to the computer calculation results, thereby controlling the pressure in the cylinder. It can simulate the surgeon's control of the puncture needle during ultrasound-guided needle puncture surgery, providing an effective training tool for improving surgical skills.

In the above-mentioned Chinese invention patent publication number CN103268726B, it is not applied to surgical practice with a blood pressure environment. In addition, the training equipment includes a cylinder, an infrared laser, a puncture needle, a handle, a double-axis two-ring frame, a connecting rod arm, a base with rollers, an ultrasonic probe model, a prosthesis model, a six-degree-of-freedom magnetic locator, two magnetic locator sensors, a computer and a cylinder control unit, etc. There is no exclusive packaging. It can also be seen from its diagram that the prosthesis model does not reveal the packaging and fixing method, and all other matching components do not reveal the packaging and fixing method, and there is no application consideration that is conducive to storage, carrying, and combining prostheses.

In order to solve the problem that the soft tissue prosthesis and the fluid conduit unit are difficult to quickly combine, and to solve the problem that the soft tissue prosthesis is easily damaged during storage and transportation, and the problem that the fluid conduit unit lacks an integral package, the present invention provides a fixing structure of the fluid conduit and the soft tissue prosthesis, comprising: a soft tissue prosthesis, which is elastic, and comprises at least one inlet and at least one outlet; a first packaging member, which packages the soft tissue prosthesis; a fluid conduit unit, which comprises a pressure element, an inflow conduit and an outflow pipe; a second package, packaging the fluid pipe unit; a control unit, electrically connected and signal connected to the pressure element; the inflow pipe is detachably connected to the pressure element and the inlet, and the outflow pipe is detachably connected to the outlet and the pressure element, so that the soft tissue prosthesis in the first package and the fluid pipe unit in the second package are connected to each other; the control unit controls the pressure element to drive a fluid to circulate between the inflow pipe, the soft tissue prosthesis and the outflow pipe.

The first packaging part and the second packaging part are both transparent shells. The first packaging part includes a first upper shell and a first lower shell that can be closed to each other, and a first accommodation chamber is formed in the first upper shell and/or the first lower shell; the second packaging part includes a second upper shell and a second lower shell that can be closed to each other, and a second accommodation chamber is formed in the second upper shell and/or the second lower shell. The soft tissue prosthesis is disposed in a first accommodation chamber of the first packaging part, and the first packaging part is disposed in a second accommodation chamber of the second packaging part.

The Shore hardness of the soft tissue prosthesis is between 30HOO and 50HOO; the material of the first packaging is one of the following: PET, PVC, PC, ABS, rubber, silicone or plastic, and the Shore hardness of the first packaging is between 40HA and 80HD; the material of the second packaging is one of the following: PET, PVC, PC, ABS, rubber, silicone or plastic, and the Shore hardness of the second packaging is between 80HA and 80HD. The Shore hardness of the inflow pipe and the outflow pipe is between 30HOO and 80HD.

The inner wall of the inflow pipe and/or the outflow pipe is provided with a protrusion.

The inflow pipe and/or the outflow pipe are further connected to an extension pipe, the free end of the extension pipe is closed, the second packaging piece is provided with an extension portion corresponding to the extension pipe, the extension portion is provided with a third accommodation chamber, and the extension pipe is placed in the third accommodation chamber.

The present invention further includes at least one sensing element, which is connected to the control unit by wire or wirelessly, and is disposed at any of the following positions: the inflow pipe, the outflow pipe, the extension pipe, and the soft tissue prosthesis. The sensing element is one of the following: a temperature sensor, a flow rate sensor, a sound sensor, an optical sensor, and a pressure sensor.

The aforementioned control unit is also connected to at least one display unit by wire or wirelessly. The control unit receives a sensing message output by the sensing element, and activates the display unit according to the sensing message.

The present invention further includes a seat having a seat fixing portion and a receiving space, the first packaging and/or the second packaging having a packaging fixing portion, the seat fixing portion is connected to fix the packaging fixing portion, so that the first packaging and the second packaging are positioned in the receiving space. The seat can be set to simulate the shape of the entire or partial human body trunk.

The aforementioned first packaging part is provided with a plurality of holes corresponding to the inlet and the outlet.

The first packaging of the present invention comprises a first upper fixing member and a first lower fixing member, and the soft tissue prosthesis is sandwiched between the first upper fixing member and the first lower fixing member in a semi-open manner; the first packaging member is selectively superimposed on the second packaging member.

The first packaging of the present invention may also include a first upper fixing member, a first covering member and a first lower fixing member, wherein the first upper fixing member is pre-set with a hollow portion, the first covering member is a single piece, the first covering member is provided with a raised portion corresponding to the soft tissue prosthesis, the soft tissue prosthesis is located in the raised portion, the first upper fixing member, the first covering member and the first lower fixing member jointly sandwich the soft tissue prosthesis, wherein the raised portion is exposed from the hollow portion. The aforementioned first packaging member and the second packaging member may be transparent or opaque.

The present invention further includes an electrode sheet, the first packaging piece packages the electrode sheet, and the electrode sheet contacts the soft tissue prosthesis.

According to the above technical features, the present invention has the following effects:

1. The soft tissue prosthesis and the fluid pipeline unit are each fixed with independent packaging, forming independent objects that are easy to store and transport. The assembly and separation between the two independent objects are extremely fast. The soft tissue prosthesis that is damaged during surgical practice can be easily replaced, which can greatly save the pre-operation time of procedural training.

2. The flowing liquid in the fluid pipeline unit has the effect of pressure expression, which can simulate the blood pressure of the human body and make the soft tissue prosthesis more realistic; the flowing liquid also has the effect of temperature change, which can make the soft tissue prosthesis simulate the temperature change of the thermal ablation surgery site, and use the surgical trainees to master the operating temperature of thermal ablation.

3. The packaging of the fluid pipeline unit can be configured with the path of the inflow pipeline, outflow pipeline or extension pipeline to improve the simulation effect. For example, a part of the packaging is shaped into an inverted Y shape to accommodate the extension pipeline, so that the extension pipeline accurately simulates the direction of the femoral artery and aorta in the human body, making it easier for doctors to practice cardiac catheterization through the femoral artery.

4. The soft tissue prosthesis packaged in an independent package can be packaged in another larger package that packages the fluid pipeline unit. At the same time, the electronic components and digital display in the control unit and fluid pipeline unit are also centrally configured, so that the soft tissue prosthesis and the fluid pipeline unit form a single object without taking up space, which is conducive to rapid fixation or removal from the seat that simulates the human trunk.

5. The first packaging is made of PET with a Shore hardness between 80HA and 80HD. The soft tissue prosthesis covered will not produce unreasonable displacement and deformation under any angle placement condition, and can also prevent damage caused by external force squeezing.

6. The first packaging and the second packaging can be transparent blister, silicone, rubber or plastic, etc. The transparent blister is conducive to observing the soft tissue prosthesis and the fluid channel unit. For example, the first packaging is made of silicone or rubber with a Shore hardness between 40HA and 60HA, which is used to package the soft tissue prosthesis. The soft tissue prosthesis can be scanned by touching the soft first packaging with an ultrasonic probe to obtain an ultrasonic image. In addition, the first packaging made of silicone or rubber with a Shore hardness between 40HA and 60HA can also present the beating feeling of the soft tissue prosthesis caused by the fluid pressure difference when the soft tissue prosthesis is covered. For another example, the soft tissue prosthesis is made transparent, and a transparent plastic (PET) of different materials or thicknesses is used to make the first packaging part to package the soft tissue prosthesis. Then, by visually viewing the soft tissue prosthesis through the first packaging part, a visual effect similar to an X-ray image can be obtained. Changing the material or thickness of the first packaging part can be used to control the transparency of the simulated X-ray image.

1,1A,1B,1C: Soft tissue prosthesis

10C: Elbow tube

11: Cavity

12: Entrance

13:Export

14B: Vascular prosthesis

15C: Cervical prosthesis

151C: Wings

16C:Thyroid prosthesis

17C: Tuberous prosthesis

18C: Arterial prosthesis

19C: Venous prosthesis

101C: Tracheal prosthesis

102C: Cervical cone prosthesis

2,2C: First packaging item

21: First upper shell part

211,211A: first recessed portion

212: First junction area

22: The first lower shell part

221: First recessed portion

222: First junction area

23: First storage room

24: Holes

25C: First upper fixing piece

251C: Hollow part

252C: Opening

26C: First covering piece

261C: bulge

2611C: Holes

27C: First lower fixing piece

270C: Groove

271C: Joint surface

272C: Opening

3,3B,3C: Fluid pipeline unit

31,31B,31C: Pressure element

32,32B,32C: Inflow pipe

321: protrusion

322C: Interface

33,33A,33B,33C: outflow pipe

331: protrusion

34,34A,34B,34C: Display unit

35: Storage space

36A: Extension pipe

361A: Fixed end

362A: Free end

4,4A,4C: Second packaging

40A: Extension

401A: The third storage room

41.41A: Second upper shell

411,411B: wide opening

412: Small opening

413,413A: Second junction area

42,42A: Second lower shell part

421: Second recessed portion

423: Second junction area

43: Second storage room

44A, 44B: Packaging fixing part

45C: Storage tank

5,5B,5C: Control unit

6,6B,6C: Sensing element

7A, 7B: Seat

70A: Column

T:Thickness

71A, 71B: Seat fixing part

72A: Accommodation space

8C: Electrode sheet

81C: Radio frequency needle

82C: Ultrasonic probe

9C: Base

A: First set

B: Second set

[Figure 1] is a three-dimensional exploded view of the first embodiment of the present invention.

[Figure 1A] is a schematic diagram of the cavity of the soft tissue prosthesis of the first embodiment of the present invention.

[Figure 1B] is a cross-sectional view of the inflow pipe and outflow pipe of the first embodiment of the present invention, showing the protrusions on the inner pipe wall of the inflow pipe and the outflow pipe.

[Figure 2] is an appearance diagram of the first kit of the first embodiment of the present invention.

[Figure 3] is a schematic diagram of the second set covering the first set in the first embodiment of the present invention.

[Figure 4] is a schematic diagram of the second kit of the first embodiment of the present invention covering the first kit, wherein the control unit is wirelessly connected to an external tablet computer.

[Fifth Figure] is a schematic diagram showing that the second set of the second embodiment of the present invention covers the first set, and the second set is fixed to the base.

[Figure 6] is a cross-sectional view of the second packaging part of the second embodiment of the present invention, where the packaging part fixing part is snapped onto the base fixing part of the base.

[Figure 6A] is a cross-sectional view of the extension portion and extension pipe of the second packaging component of the second embodiment of the present invention.

[Figure 7] is a schematic diagram of the second set covering the first set in the third embodiment of the present invention, and the second set is fixed to the base, wherein the soft tissue prosthesis is a liver prosthesis.

[Figure 8] is a three-dimensional exploded view of the fourth embodiment of the present invention, showing the present invention applied to a cervical prosthesis.

[Figure 8A] is a schematic diagram of the configuration of the fluid pipeline unit of the fourth embodiment of the present invention.

[Figure 9] is a schematic diagram of the fourth embodiment of the present invention performing ultrasonic ultrascanning and radio frequency ablation on a nodule prosthesis.

Combining the above technical features, the main features of the fixing structure of the fluid conduit and the soft tissue prosthesis of the present invention will be clearly presented in the following embodiments.

Please refer to the first figure, the first A figure, the first B figure and the second figure. The first embodiment of the present invention comprises a soft tissue prosthesis 1, a first packaging part 2, a fluid channel unit 3, a second packaging part 4 and a control unit 5, wherein:

In the first embodiment, the soft tissue prosthesis 1 is a heart prosthesis, which is elastic, has a Shore hardness between 30HOO and 50HOO, and contains 60 parts by weight of polyvinyl alcohol (PVA), 600 parts by weight of glycerol, and 1400 parts by weight of deionized water. During the shaping process of the heart prosthesis, freezing and thawing operations are performed to form an elastic colloid, and the freezing temperature is, for example, -20°C, and the freezing time is 24 hours. The heart prosthesis can be constructed into a three-dimensional image file based on the image of the computer tomography scan, and then the heart prosthesis is molded and manufactured based on the three-dimensional image file. The manufactured soft tissue prosthesis 1 includes at least one cavity 11, at least one inlet 12 and at least one outlet 13, wherein the plurality of cavities 11 correspond to the left atrium, right atrium, left ventricle and right ventricle of the human heart, the plurality of inlets 12 correspond to the positions of the human superior vena cava, inferior vena cava, right pulmonary vein and left pulmonary vein connected to the human heart, and the plurality of outlets 13 correspond to the positions of the human heart connected to the brachiocephalic artery, left common carotid artery, left subclavian artery, left pulmonary artery, right pulmonary artery and descending aorta. In addition to heart prostheses, the soft tissue prosthesis 1 of the present invention can also be a prosthesis of other human organs, such as a liver prosthesis, a neck prosthesis, a bladder prosthesis or a genital prosthesis, etc.

The material of the first packaging 2 can be PET, PVC, PC, ABS, rubber, silicone or plastic, etc., with a Shore hardness between 80HA and 80HD. The first packaging 2 of this embodiment is a PET transparent bubble shell. The first packaging 2 includes a first upper shell 21 and a first lower shell 22 that can be closed to each other. The first upper shell 21 and the first lower shell 22 both have a first recessed portion 211, 221. Preferably, the shape of the first recessed portion 211, 221 corresponds to the shape of the soft tissue prosthesis 1 and is set to be slightly larger than the soft tissue prosthesis 1. When the first upper shell 21 and the first lower shell 22 are closed to each other, the first recessed portions 211, 221 together form a first accommodation chamber 23, and the first accommodation chamber 23 is used to accommodate the aforementioned soft tissue prosthesis 1. The first upper shell 21 and the first lower shell 22 have planar first joint areas 212, 222 outside the first recessed portions 211, 221. The first upper shell 21 and the first lower shell 22 are closed to each other by hot melting, high frequency, gluing or snap fastening of the two first joint areas 212, 222. The snap fastening method is suitable for the situation where the soft tissue prosthesis 1 needs to be taken in and put in the first accommodation chamber 23 multiple times. The first recessed portions 211, 221 are provided with a plurality of holes 24 corresponding to the inlet 12 and outlet 13 of the soft tissue prosthesis 1, so that the soft tissue prosthesis 1 can be placed in the first receiving chamber 23, and then the inlet 12 and outlet 13 can pass through the holes 24. The first packaging 2 can also be non-transparent if there is no need for transparency.

The fluid pipeline unit 3 includes two pressure elements 31, a plurality of inflow pipelines 32 and a plurality of outflow pipelines 33. Each of the pressure elements 31 has a built-in pump, a motor, a battery and a water tank. The Shore hardness of the inflow pipeline 32 and the outflow pipeline 33 is between 30HOO and 80HD. The inflow pipeline 32 and the outflow pipeline 33 of this embodiment are elastic tubes, and part of the inflow pipeline 32 is provided with branches. The inflow pipeline 32 is used to simulate human veins, and the outflow pipeline 33 is used to simulate human arteries. The inflow pipeline 32 or the outflow pipeline 33 can be made of silicone, and protrusions 321, 331 are formed on part of the inner wall during molding to simulate the narrowed section of the human artery or vein. The fluid pipeline unit 3 is also provided with a display unit 34, which can be fixed on the inflow pipeline 32 or the outflow pipeline 33. The display unit 34 can be a digital display, such as a pressure gauge, a temperature gauge, a flow rate gauge, etc., or a light-emitting element or a sound-emitting element. The display unit 34 of this embodiment is a pressure gauge. All pressure elements 31, inflow pipelines 32 and outflow pipelines 33 are arranged around a horizontal plane as much as possible, and a storage space 35 is reserved in the middle. If the inflow pipeline 32 and the outflow pipeline 33 are not used to simulate human blood vessels, but only to transport liquids, the inflow pipeline 32 and the outflow pipeline 33 of the present invention can also be made of hard plastic.

The material of the second packaging part 4 can be PET, PVC, PC, ABS, rubber, silicone or plastic, with a Shore hardness between 80HA and 80HD. The second packaging part 4 of this embodiment is a transparent PET foam shell, but the second packaging part 4 of the present invention is not limited to transparent materials. The second packaging part 4 includes a second upper shell 41 and a second lower shell 42 that can be closed to each other, wherein the second lower shell 42 has a second recessed portion 421, preferably the shape of the second recessed portion 421 corresponds to and is slightly larger than the arrangement outline of the above-mentioned fluid pipeline unit 3 and the outline of the first recessed portion 221 of the above-mentioned first lower shell 22, for accommodating the above-mentioned fluid pipeline unit 3 and the closed first packaging part 2. The second upper shell 41 is in sheet form, with a large opening 411 and a small opening 412. The second upper shell 41 has a second joint area 413 at the periphery of the large opening 411 and the small opening 412, and the second lower shell 42 has a planar second joint area 423 outside the recessed portion 421. When the second upper shell 41 and the second lower shell 42 are closed to each other, a second receiving chamber 43 is formed between the second recessed portion 421 and the large opening 411. The second upper shell 41 and the second lower shell 42 are closed to each other by hot melting, high frequency, gluing, snapping, etc. of the two second joint areas 413 and 423.

The control unit 5 has a built-in battery, a computing unit, and a wireless module. The control unit 5 is electrically and signal-connected to the pressure element 31 to control the action of the pressure element 31, such as opening, closing, changing the pressure, etc.

The present invention further includes a sensing element 6, which is electrically and signal-connected to the control unit 5. The sensing element 6 is disposed at the aforementioned soft tissue prosthesis 1, the inflow pipe 32 or the outflow pipe 33, etc. The sensing element 6 is, for example, a temperature sensor, a flow rate sensor, a sound sensor, an optical sensor or a pressure sensor, etc., for sensing the information of the soft tissue prosthesis 1, the inflow pipe 32 or the outflow pipe 33. In this embodiment, the sensing element 6 is a pressure sensor. The sensing unit 3 and the aforementioned display unit 34 are both optional accessories. The present invention can be implemented without using the sensing unit 3 and the display unit 34.

As shown in the second figure, after the soft tissue prosthesis 1 is packaged in the first accommodation chamber 23, the inlet 12 and the outlet 13 pass through the hole 24 to form the first set A. By packaging in a transparent bubble shell, the soft tissue prosthesis 1 will not be deformed, and the soft tissue prosthesis 1 can also be directly visually observed. The first set A is convenient for storage, setting on a dummy model, putting into a suitcase, container, box or directly displaying, and can maintain the shape of the bionic prosthesis.

In the first figure, the remaining components of the first set A are not included, that is, the second set B is formed after the fluid pipeline unit 3 is packaged with the second packaging part 4.

The first set A and the second set B can be separately arranged and connected by appropriately extending the inflow pipe 32 and the outflow pipe 33. They can also be stacked and connected. The first embodiment is described in the form of a stacked configuration of the first set A and the second set B.

Please refer to the first, second and third figures. Open the second upper shell 41 of the second set B, place the first set A shown in the second figure in the accommodation space 35 at the middle part of the fluid pipeline unit 3, so that the two ends of the inflow pipeline 32 are detachably connected to the pressure element 31 and the aforementioned inlet 12, and the two ends of the outflow pipeline 33 are detachably connected to the aforementioned outlet 13 and the pressure element 31, so that the soft tissue prosthesis 1 and the fluid pipeline unit 3 are connected to each other to form a circulation system. Afterwards, the second upper shell 41 is covered so that the first recessed portion 211 of the first upper shell 41 is exposed from the large opening 411 of the second upper shell 41, and one of the display units 34 is exposed from the small opening 412 of the second upper shell 41, completing the overlapping configuration of the second set B covering the first set A.

The first packaging part 2 may also be made of a silicone material with a Shore hardness between 40HA and 60HA. The first packaging part 2 can tightly cover the soft tissue prosthesis 1 so as to allow the ultrasonic probe to practice scanning the soft tissue prosthesis 1. The aforementioned recessed portion 211 is directly exposed from the large opening 411 of the second upper shell 41, which is conducive to the ultrasonic probe directly contacting the recessed portion 211 to practice scanning the packaged soft tissue prosthesis 1. If the first packaging part 2 does not tightly cover the soft tissue prosthesis 1, and there is a gap between the two, during the practice, the gap can be eliminated by applying appropriate pressure to the recessed part 211 with the ultrasound probe, and the scanning can be performed smoothly. Alternatively, the gap can be filled with gel through the aforementioned inlet 12 and outlet 13, and the ultrasound scan can also be performed smoothly to obtain the ultrasound image of the soft tissue prosthesis 1. In addition, because the first packaging part 2 uses the above-mentioned soft and elastic silicone material, when the soft tissue prosthesis 1 is covered, when the fluid channel unit 3 simulates blood circulation, the soft tissue prosthesis 1 can still present the beating feeling formed by the high and low pressure difference of the simulated blood when being covered.

If the first packaging 2 is made of transparent PET and the soft tissue prosthesis 1 is also made transparent, the trainee can visually observe the transparent soft tissue prosthesis 1 and obtain a visual effect similar to an X-ray image, thereby practicing and observing the simulated operation process of the cardiac catheter. The transparency of the simulated X-ray image can be changed by using PET of different transparencies or PET of different thicknesses, for example, PET thickness ranging from 0.5 to 3 mm.

The aforementioned soft tissue prosthesis 1, first packaging 2, second packaging 4, inflow pipe 32 and outflow pipe 33, etc., can be controlled in transparency and color by adding dyes during the molding process.

The aforementioned recessed portion 211 is directly exposed from the large opening 411 of the second upper shell 41, which is only one of the embodiments of the present invention. If it is not necessary to perform ultrasonic scanning practice, the large opening 411 of the second upper shell 41 is changed to another recessed portion facing upwards, so that the second upper shell 41 is similar to a hat, which is also a feasible embodiment. In addition, the aforementioned display unit 34 is exposed from the small opening 412 of the second upper shell 41, which can facilitate a clearer visual observation of the specific display unit 34, but it is not necessary for the display unit 34 to be exposed from the small opening 412 of the second upper shell 41. Even if the second upper shell 41 does not have any small opening 412, all the display units 34 are covered by the second upper shell 41, and the display unit 34 can still be visually read through the transparent second upper shell 41.

Please refer to the fourth figure. The pressure element 31 is controlled by the control unit 5 to make the fluid simulating blood circulate between the inflow pipe 32, the soft tissue prosthesis 1, the outflow pipe 33 and the pressure element 31. The pressure of the fluid is controllable to simulate the cardiovascular system of the human body. The pressure of the fluid is sensed by the sensing unit 6, and the sensing result is transmitted to the control unit 5. After calculation, the control unit drives the display unit 34 to display the pressure values of different parts. The above-mentioned control unit 5 can also output the calculated result to an external display unit 34, such as a mobile phone, a tablet computer, a computer or a wearable device. The mobile phone, tablet computer, computer or wearable device can be connected to the control unit by wire or wirelessly. The control unit 5 can also be remotely controlled by a mobile phone, tablet, computer or wearable device.

The second set B shown in the fourth figure covers the first set A and is stacked as a whole. The whole is easy to carry, does not take up space, and is also convenient for installation on the human body model. The transparent bubble shell is convenient for visual observation and data reading, and the soft tissue prosthesis 1 is not easily deformed by external force.

Please refer to FIG. 5, FIG. 6 and FIG. 6A, the second embodiment of the present invention further comprises a seat 7A, and the seat 7A is used to install the aforementioned first set A and/or second set B. The seat 7A of the present embodiment is made of plastic, preferably hard plastic, and the seat 7A simulates the back shell of the human body trunk, and the shell has a thickness T. The shell defines a receiving space 72A, and a plurality of columns 70A are disposed in the receiving space 72A. The free end of the column 70A is provided with a seat fixing portion 71A, and the seat fixing portion 71A of the present embodiment is a groove. A relatively symmetrical human trunk front shell (not shown in the fifth figure) can be used to cover and close the seat 7A, and the above-mentioned accommodating space 72A can be closed to form a closed human trunk model. In the fifth figure, an elastic inverted Y-shaped extension pipe 36A is also provided. The fixed end 361A of the extension pipe 36A is connected to the outflow pipe 33A, and the two free ends 362A of the extension pipe 36A are closed. The extension pipe 36A is used to simulate the femoral artery and aorta of the human body. The second packaging component 4A further includes an inverted Y-shaped extension portion 40A, which is formed by the second upper shell component 41A and the second lower shell component 42A covering each other. A third accommodating chamber 401A is pre-set in the extension portion 40A. The third accommodating chamber 401A is an inverted Y-shaped circular groove for accommodating the aforementioned extension pipe 36A. Preferably, the shape of the third accommodating chamber 401A corresponds to the paths of the femoral artery and the aorta of the human body. The second joint area 413A of the second packaging part 4A is provided with a plurality of packaging part fixing parts 44A, which are formed by the mutual engagement of an upper groove 414A of the second upper shell 41A and a lower groove 424A of the second lower shell 42A. The shape of the packaging part fixing part 44A corresponds to the aforementioned seat fixing part 71A, so that the packaging part fixing part 44A can be fastened and fixed to the seat fixing part 71A. The aforementioned seat 7A is used for the installation of the first set A and the second set B. The shape of the seat 7A is not limited to simulating the human body trunk, and can also be rectangular, square or circular, etc. The material can also be selected from rubber or silicone, etc.

Doctors can use a catheter to penetrate the free end 362A of the extension tube 36A and enter the soft tissue prosthesis 1A along the extension tube 36A to practice related operations of cardiac catheterization. The elasticity of the free end 362A can properly tighten the catheter to prevent a large amount of liquid in the extension tube 36A from flowing out. The inverted Y-shaped extension tube 36A correctly simulates the path of the femoral artery and the aorta of the human body, making the practice operation more realistic. The inverted Y-shaped third accommodation chamber 401A preset in the extension part 40A of the second package 4A effectively restricts the extension tube 36A so that the extension tube 36A will not shift. In addition, the package fixing part 44A is snapped into the seat fixing part 71A, so that the second package 4A is fixed in the seat, and the second package 4A covers the first package 2A, so that the first package 2A is also fixed. If the front shell of the human trunk is not covered, during the practice of cardiac catheterization surgery, the first recessed part 211A can be contacted with an ultrasonic probe to scan the soft tissue prosthesis 1A. The display unit 34A can display relevant data during the practice process, such as simulated blood pressure.

Please refer to Figure 7. In the third embodiment, the soft tissue prosthesis 1B covered by the first set A is an elastic liver prosthesis, which includes many branched vascular prostheses 14B. The second set B partially covers the first set A, and the second set B also reserves a large opening 411B for the first set A to be partially exposed. The second kit B also includes a fluid pipeline unit 3B, wherein the inflow pipeline 32B connects the pressure element 31B and the vascular prosthesis 14B, and the outflow pipeline 33B connects the vascular prosthesis 14B and the pressure element 31B. A circulation system is formed among the inflow pipeline 32B, the vascular prosthesis 14B and the outflow pipeline 33B. The circulation system is also filled with liquid, wherein the inflow pipeline 32B simulates the human portal vein, and the outflow pipeline 33B simulates the human hepatic vein. The second set B is also provided with a plurality of display units 34B, a control unit 5B and a sensing unit 6B, wherein the control unit 5B is electrically connected and signal-connected to the pressure element 31B, the display unit 34B and the sensing unit 6B. The second set B is fixed to the base fixing portion 71B preset by the base 7B through the packaging fixing portion 44B in the same manner as the above embodiment.

Please refer to FIG. 8, FIG. 8A and FIG. 9. In the fourth embodiment, the soft tissue prosthesis 1C includes a cervical prosthesis 15C, a thyroid prosthesis 16C, a tubercle prosthesis 17C, an arterial prosthesis 18C and a venous prosthesis 19C, wherein the cervical prosthesis 15C is provided with a receiving space corresponding to the shape of the thyroid prosthesis 16C and the shape of the tracheal prosthesis 101C described later, and the receiving space is not shown in FIG. 8, and the receiving space is used to receive the thyroid prosthesis 16C and the tracheal prosthesis 101C. The thyroid prosthesis 16C mentioned above also covers the tubercle prosthesis 17C. The neck prosthesis 15C, the thyroid prosthesis 16C and the nodule prosthesis 17C are made of hydrogel materials with different hardness. The soft tissue prosthesis 1C can be used to simulate thermal ablation surgery of thyroid nodules, such as microwave ablation or radio frequency ablation. The arterial prosthesis 18C passes through the edge of the thyroid prosthesis 16C. The arterial prosthesis 18C is used to simulate the common carotid artery of the human body. The venous prosthesis 19C is used to simulate the internal carotid artery of the human body. The arterial prosthesis 18C of this embodiment has two inlets 181C, and the venous prosthesis 19C has two outlets 191C. The arterial prosthesis 18C and the venous prosthesis 19C are connected by two loop tubes 10C. The neck prosthesis 15C is assembled with other hard prostheses, that is, the neck prosthesis 15C covers a hard tracheal prosthesis 101C, and the tracheal prosthesis 101C and a segmented cervical cone prosthesis 102C are stacked on each other, wherein the cervical cone prosthesis 102C is not covered by the neck prosthesis 15C. The first packaging member 2C of this embodiment includes a first upper fixing member 25C, a first covering member 26C and a first lower fixing member 27C, wherein the first upper fixing member 25C is pre-set with a hollow portion 251C and two openings 252C, and the two openings 272C are for the inflow pipe 32C and the outflow pipe 33C in the fluid pipe unit 3C described later to pass through. The first covering member 26C is a single piece and has a raised portion 261C corresponding to the cervical prosthesis 15C. The cervical prosthesis 15C is located in the raised portion 261C. The raised portion 261C is pre-set with a plurality of holes 2611C for the arterial prosthesis 18C and the venous prosthesis 19C to pass through. The first lower fixing member 27C has a joint surface 271C and a groove 270C, wherein the joint surface 271C can be used to place two electrode sheets 8C, and the electrode sheets 8C serve as negative electrode patches during the radio frequency ablation operation. The joint surface 271C also has two openings 272C reserved for the inflow pipe 32C and the outflow pipe 33C in the fluid pipe unit 3C described later to pass through. The above-mentioned groove 270C is used to accommodate the aforementioned cervical cone prosthesis 102C. When performing thermal ablation, if microwave ablation is used, the aforementioned electrode sheet 8C can be omitted.

The second package 4C of this embodiment has a receiving groove 45C, and the contour shape of the second package 4C corresponds to the first package 2C, so that the first package 2C can be stacked on the second package 4C. The receiving groove 45C can accommodate components such as the pressure element 31C, the inflow pipe 32C, the outflow pipe 33C and the display unit 34C in the control unit 5C and the fluid pipeline unit 3C. The first package 2C and the second package 4C are also placed together in a base 9C, which is convenient for storage and carrying, but the base 9C is not a necessary component of the present invention. For example, the first package 2C and the second package 4C are separately configured, or the first package 2C and the second package 4C are fixed to each other by other means, such as screw locking, gluing, snap-fitting, etc., which are all feasible embodiments of the present invention. In this embodiment, the first packaging part 2C and the second packaging part 4C are both transparent.

The first packaging part 2C of this embodiment covers the soft tissue prosthesis 1C, the tracheal prosthesis 101C and the cervical cone prosthesis 102C to form a first set A, and the second packaging part 4C covers the control unit 5C and the fluid pipeline unit 3C to form a second set B.

The above-mentioned fluid pipeline unit 3C further includes a cooling element 37C and an instant heating module 38C. The pressure element 31C delivers the liquid, which is heated by the instant heating module 38C to keep the temperature of the liquid between 36°C and 37°C. The liquid flows into the arterial prosthesis 18C through the two interfaces 322C of the inflow pipeline 32C, and then flows back to the venous prosthesis 19C, returns to the outflow pipeline 33C, and then returns to the pressure element 31C through the cooling element 37C to form a cycle. The relevant temperature control can be achieved by sensing the temperature of the fluid through the sensing element 6C, and then the operation of the cooling element 37C and the instant heating module 38C can be further controlled by the control unit 5C.

The first covering member 26C can be a bubble shell or a silicone sheet. In this embodiment, it is a silicone sheet. The first covering member 26C covers the cervical prosthesis 15C. The first upper fixing member 25C and the first lower fixing member 27C jointly cover the first covering member 26C, the cervical prosthesis 15C, the tracheal prosthesis 101C and the cervical cone prosthesis 102C. The inflow pipe 32C and the outflow pipe 33C packaged by the second packaging member 4C are connected to the aforementioned arterial prosthesis 18C and venous prosthesis 19C. The pressure element 31C provides a pressure source to make the liquid circulate between the arterial prosthesis 18C and the venous prosthesis 19C. As for the power required by the pressure element 31C and the control unit 5C, a battery or an external AC power supply can be configured in the second package 4C.

When practicing radio frequency ablation, the ultrasonic probe 82C contacts the raised portion 261C of the first cover 26C to perform an ultrasonic scan on the cervical prosthesis 15C, and obtains the ultrasonic images of the thyroid prosthesis 16C and the nodule prosthesis 17C. With the aid of the ultrasonic image, the radio frequency needle 81C is passed through the cervical prosthesis 15C to the position of the nodule prosthesis 17C. By grounding the electrode piece 8C, the current of the radio frequency needle 81C can thermally ablate the nodule prosthesis 17C. During the thermal ablation process, the liquid flowing through the arterial prosthesis 18C simulates human blood, and its liquid temperature is between 36℃ and 37℃. When the liquid passes near the thyroid prosthesis 16C, since the temperature of thermal ablation is approximately between 60℃ and 80℃, the flowing liquid will take away part of the heat energy in the thermal ablation operation, which is the same as the situation in which blood takes away part of the heat energy of thermal ablation in real surgery. Through the above simulation operation, the practitioner can more accurately grasp the temperature changes during the thermal ablation process and increase or decrease the operating temperature of thermal ablation in a timely manner. Since both the first package 2C and the second package 4C are transparent, the display unit 34C in the second package 4C can be visually viewed during the training process. The display unit 34C is used to display information such as the temperature of the liquid, the flow rate of the liquid, the operating temperature of thermal ablation, the pressure of the arterial prosthesis 18C, and the pressure of the venous prosthesis 19C. If the first upper fixing member 25C and the first lower fixing member 27C are pre-set with openings to allow the display unit 34C to be exposed, it is also a feasible embodiment of the present invention.

In the fourth embodiment, wings 151C extend from both sides of the bottom of the neck prosthesis 15C, and the two wings 151C can be sandwiched by the first upper fixing member 25C and the first lower fixing member 27C to fix the neck prosthesis 15C. The first covering member 26C of the fourth embodiment is made of silicone material, and the neck prosthesis 15C, the thyroid prosthesis 16C, and the tubercle prosthesis 17C are made of hydrogel material, so that ultrasonic images of the neck prosthesis 15C, the thyroid prosthesis 16C, and the tubercle prosthesis 17C can be obtained by ultrasonic scanning. However, if the first covering member 26C is omitted, and only the first upper fixing member 25C and the first lower fixing member 27C are used to sandwich the two wings 151C, so that the neck prosthesis 15C is directly exposed from the hollow portion 251C of the first upper fixing member 25C, forming a semi-open package, the neck prosthesis 15C can also be stably fixed, which is also a feasible embodiment of the present invention.

Combined with the description of the above embodiments, the operation, use and effects of the present invention can be fully understood. However, the above embodiments are only preferred embodiments of the present invention and cannot be used to limit the scope of implementation of the present invention. In other words, simple equivalent changes and modifications made according to the scope of the patent application and the content of the invention description are all within the scope of the present invention.

1: Soft tissue prosthesis

12: Entrance

13:Export

2: First packaging piece

21: First upper shell part

211: First recessed portion

212: First junction area

22: The first lower shell part

221: First recessed portion

222: First junction area

23: First storage room

24: Holes

3: Fluid pipeline unit

31: Pressure element

32: Inflow pipe

33: Outflow pipe

34: Display unit

4: Second packaging

41: Second upper shell

411: Wide Open

412: Small opening

413: Second junction area

42: Second lower shell part

421: Second recessed portion

43: Second storage room

5: Control unit

6: Sensing element

A: First set

B: Second set

Claims (16)

A fixing structure of a fluid pipeline and a soft tissue prosthesis comprises: a soft tissue prosthesis having elasticity and comprising at least one inlet and at least one outlet; a first packaging component packaging the soft tissue prosthesis; a fluid pipeline unit comprising a pressure element, an inflow pipeline and an outflow pipeline; a second packaging component packaging the fluid pipeline unit; a control unit electrically connected to the pressure element and connected to the pressure element by a signal; The pressure element is provided with a pressure pipe; the inlet is detachably connected to the pressure element, and the outlet is detachably connected to the pressure element, so that the soft tissue prosthesis in the first package and the fluid pipe unit in the second package are connected to each other; the control unit controls the pressure element to drive a fluid to circulate between the inlet pipe, the soft tissue prosthesis and the outlet pipe. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1, wherein the first packaging part and the second packaging part are both transparent shells, the first packaging part comprises a first upper shell part and a first lower shell part that can be closed to each other, and a first accommodation chamber is formed in the first upper shell part and/or the first lower shell part; the second packaging part comprises a second upper shell part and a second lower shell part that can be closed to each other, and a second accommodation chamber is formed in the second upper shell part and/or the second lower shell part. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 2, wherein the soft tissue prosthesis is disposed in a first receiving chamber of the first packaging component, and the first packaging component is disposed in a second receiving chamber of the second packaging component. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1, wherein the Shore hardness of the soft tissue prosthesis is between 30HOO and 50HOO; the material of the first packaging is one of the following: PET, PVC, PC, ABS, rubber, silicone or plastic, and the Shore hardness of the first packaging is between 40HA and 80HD; the material of the second packaging is one of the following: PET, PVC, PC, ABS, rubber, silicone or plastic, and the Shore hardness of the second packaging is between 80HA and 80HD. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1, wherein the Shore hardness of the inflow conduit and the outflow conduit is between 30HOO and 80HD. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1, wherein the inner tube wall of the inflow conduit and/or the outflow conduit is provided with a protrusion. As described in claim 1, the fixing structure of the fluid conduit and the soft tissue prosthesis, wherein the inflow conduit and/or the outflow conduit is further connected to an extension conduit, the free end of the extension conduit is closed, the second packaging piece is provided with an extension portion corresponding to the extension conduit, the extension portion is provided with a third accommodation chamber, and the extension conduit is placed in the third accommodation chamber. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1 further includes at least one sensing element, which is connected to the control unit by wire or wirelessly, and is arranged at any of the following positions: the inflow conduit, the outflow conduit and the soft tissue prosthesis. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 8, wherein the sensing element is one of the following: a temperature sensor, a flow rate sensor, a sound sensor, an optical sensor, and a pressure sensor. As described in claim 8, the fixing structure of the fluid conduit and the soft tissue prosthesis, wherein the control unit is also connected to at least one display unit by wire or wirelessly, and the control unit receives a sensing message output by the sensing element, and the control unit activates the display unit according to the sensing message. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1 further comprises a seat having a seat fixing portion and a receiving space, the first packaging and/or the second packaging having a packaging fixing portion, the seat fixing portion is connected to and fixed to the packaging fixing portion, so that the first packaging and the second packaging are positioned in the receiving space. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1, wherein the first packaging part is provided with a plurality of holes corresponding to the inlet and the outlet. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1, wherein the first packaging part comprises a first upper fixing part and a first lower fixing part, and the soft tissue prosthesis is sandwiched between the first upper fixing part and the first lower fixing part in a semi-open manner; the first packaging part is selectively superimposed on the second packaging part. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1, wherein the first packaging part comprises a first upper fixing part, a first covering part and a first lower fixing part, wherein the first upper fixing part is pre-set with a hollow part, the first covering part is a single piece, the first covering part is provided with a raised part corresponding to the soft tissue prosthesis, the soft tissue prosthesis is located in the raised part, the first upper fixing part, the first covering part and the first lower fixing part jointly sandwich the soft tissue prosthesis, wherein the raised part is exposed from the hollow part. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 13 or claim 14, wherein the first packaging and the second packaging are both transparent. The fixing structure of the fluid conduit and the soft tissue prosthesis as described in claim 1 further comprises an electrode sheet, the first packaging piece packages the electrode sheet, and the electrode sheet contacts the soft tissue prosthesis.

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