Tissue-mimicking phantom material for needle insertion, and preparation method therefor and tissue-mimicking phantom for needle insertion

Abstract

Disclosed in the present application are a tissue-mimicking phantom material for needle insertion and a preparation method therefor. The tissue-mimicking phantom material is an aqueous gel, and comprises the following raw materials in percentages by mass: 0.2%-0.8% of sodium carboxymethyl cellulose, 0.05%-0.5% of xanthan gum, 0.2%-1.5% of carrageenans, 7%-12% of agar, and 0.2%-1% of a preservative, with the balance being purified water. The preparation method comprises: (1) uniformly mixing the raw materials; (2) heating the resulting mixture and maintaining same at 90-100°C for 30-60 min; and (3) cooling the mixture to obtain a tissue-mimicking phantom material for needle insertion. Further disclosed is a tissue-mimicking phantom for needle insertion, the phantom comprising an outer frame, simulated skin, a tissue-mimicking phantom material, a simulated lesion and a sound-absorbing material. The tissue-mimicking phantom for needle insertion has the advantages of being capable of simulating a lesion in a human body, providing clear imaging and having a sound velocity consistent with that of the human body; capable of allowing multiple needle insertions and realizing real-time observation of insertion paths and results; effectively improving the insertion proficiency of physicians, and shortening the learning path; etc.

Description

Materials for tissue puncture phantoms and their preparation methods, and tissue puncture phantoms Technical Field

[0001] This application relates to medical models, particularly to materials for tissue puncture phantoms, methods for their preparation, and tissue puncture phantoms. Background Technology

[0002] With the development of medicine, interventional therapy, as an emerging interdisciplinary science, has become a new clinical discipline situated between traditional internal medicine and surgery, and is known as the third major diagnostic and treatment system in modern clinical therapeutics. Simultaneously, surgical treatment is shifting from open surgery to image-guided interventional minimally invasive surgery. Minimally invasive surgery, characterized by less trauma, lower complication rates, and faster recovery, is increasingly favored by doctors and patients.

[0003] Interventional puncture surgery is one of the most common types of interventional minimally invasive surgery. It is generally performed under the guidance of imaging equipment such as CT, MRI, and ultrasound. Ultrasound-guided interventional puncture, in particular, involves using appropriate puncture instruments to puncture the lesion under the guidance of an ultrasound probe, followed by further procedures such as biopsy, aspiration catheterization, and drug injection.

[0004] Ultrasound-guided interventional puncture surgery requires the operator to have a thorough understanding of human anatomy, especially the ability to combine ultrasound images with anatomical structures to create a three-dimensional picture, in order to accurately complete the interventional puncture procedure. It demands a high level of skill in both ultrasound operation and puncture technique, requiring repeated practice and a long learning path.

[0005] Currently, there are many ultrasound tissue phantoms on the market, but most of them are only used for the confirmation and calibration of ultrasound image performance. There is a lack of tissue puncture phantoms that can simulate human tissue for ultrasound image display and also allow for puncture practice and observation confirmation. Summary of the Invention

[0006] To address the shortcomings of existing technologies, this application aims to provide a tissue puncture phantom to solve the problem that existing ultrasound tissue puncture phantoms can only be used for image scanning and not for interventional puncture practice. The tissue puncture phantom of this application has advantages such as allowing for repeated punctures, effectively improving the physician's puncture proficiency, and shortening the learning path.

[0007] To address the problems existing in the prior art, the technical solution of this application is as follows:

[0008] In a first aspect, this application provides a tissue puncture phantom material, wherein the tissue puncture phantom material is a hydrogel, and its raw materials, by mass percentage, include 0.2%-0.8% sodium carboxymethyl cellulose, 0.05%-0.5% xanthan gum, 0.2%-1.5% staghorn tartar gum, 7%-12% agar, 0.2%-1% preservative, and the remainder being purified water.

[0009] Preferably, the raw materials include 0.3%-0.6% sodium carboxymethyl cellulose, 0.1%-0.3% xanthan gum, 0.3%-1% staghorn gum, 7.6%-8.7% agar, 0.3%-0.6% preservative, and the remainder being purified water.

[0010] Preferably, the sound velocity of the simulated tissue puncture phantom material is 1530-1550 m / s.

[0011] Preferably, the acoustic attenuation coefficient slope of the simulated tissue puncture phantom material is 0.15dB / (cm·MHz)-0.25dB / (cm·MHz).

[0012] Secondly, this application provides a method for preparing the above-mentioned tissue puncture phantom material, comprising the following steps:

[0013] (1) Mix the raw materials evenly;

[0014] (2) Then heat at 90-100℃ for 30-60 minutes;

[0015] (3) Cooling, and the tissue puncture phantom material is obtained.

[0016] Thirdly, this application provides a tissue puncture phantom comprising:

[0017] The outer frame has a certain volume of storage space;

[0018] Simulated skin, which is disposed on the upper part of the receiving space within the outer frame, is used to simulate the hardness of human skin;

[0019] The above-mentioned tissue phantom material or the tissue puncture phantom material prepared by the above-mentioned preparation method is placed in the receiving space to simulate the surrounding tissues in the human body, and can simulate the imaging of the surrounding tissues in the human body under the processing of the imaging device.

[0020] The simulated lesion is set in the simulated tissue phantom material to simulate lesions in human organs and can be imaged under the processing of imaging equipment;

[0021] Sound-absorbing material, disposed in the lower part of the receiving space within the outer frame, is used to prevent the bottom from reflecting ultrasound.

[0022] Preferably, the simulated skin comprises two components, A and B, wherein component A comprises silicone and component B comprises a curing agent.

[0023] Preferably, the simulated skin has an air content of no more than 20 bubbles per square centimeter.

[0024] Preferably, the puncture force for puncturing the simulated skin is 1-5N.

[0025] Preferably, the thickness of the simulated skin is 3-6 mm.

[0026] The beneficial effects of this application include at least the following:

[0027] 1. It can simulate lesions in the human body, with clear imaging and sound speed consistent with the human body;

[0028] 2. It can be repeatedly punctured, and the puncture path and results can be observed in real time;

[0029] 3. It can effectively improve doctors' proficiency in puncture and shorten the learning path.

[0030] The features and advantages of this application will be described in detail in the following detailed description section. Attached Figure Description

[0031] Figure 1 is a schematic diagram of the structure of a tissue puncture phantom according to this application.

[0032] Figure 2 shows an ultrasound image of a tissue puncture phantom of this application.

[0033] Figure 3 shows a CT image of a tissue puncture phantom from this application.

[0034] Figure 4 shows an ultrasound-guided CT imaging of a tissue puncture phantom according to this application.

[0035] Figure 5 shows the gas content of components A and B of the simulated skin in the tissue puncture phantom of this application at different proportions.

[0036] Figure 6 shows the puncture force of simulated skin components A and B at different ratios in the tissue puncture phantom of this application.

[0037] Explanation of reference numerals in the attached diagram: 1. Outer frame; 11. Protective cover; 12. Top frame; 13. Transparent frame; 14. Handle; 15. Base; 2. Simulated skin; 3. Tissue-like phantom material; 4. Simulated lesion; 5. Sound-absorbing material. Detailed Implementation

[0038] To make the objectives, technical solutions, and beneficial effects of this application clearer, the application will be further described in detail below with reference to the accompanying drawings and specific embodiments. Examples of the embodiments are shown in the accompanying drawings. It should be understood that the specific embodiments described in the following embodiments of this application are merely illustrative examples of specific implementations of this application and are intended to explain this application, and do not constitute a limitation thereof.

[0039] The endpoints and any values ​​of the ranges disclosed herein are not limited to the precise ranges or values, and should be understood to include values ​​close to these ranges or values. For numerical ranges, the endpoint values ​​of the various ranges, the endpoint values ​​of the various ranges and individual point values, and individual point values ​​can be combined with each other to obtain one or more new numerical ranges, which should be considered as specifically disclosed herein. It should be noted that, as used in this application, in the numerical values ​​of specific embodiments, the value can vary by ±2% as the numerical protection range of this application.

[0040] In the description of this application, unless otherwise stated, the terms "multiple / areas" and similar terms mean two / a kind or more. Furthermore, the terms "comprising," "including," and any variations thereof are intended to cover non-exclusive inclusion.

[0041] In a first aspect, this application provides a tissue puncture phantom material, wherein the tissue puncture phantom material is a hydrogel, and its raw materials, by mass percentage, include 0.2%-0.8% sodium carboxymethyl cellulose, 0.05%-0.5% xanthan gum, 0.2%-1.5% staghorn tartar gum, 7%-12% agar, 0.2%-1% preservative, and the remainder being purified water.

[0042] In this application, the tissue puncture phantom material may also be referred to as TM material.

[0043] In some preferred embodiments, the raw materials of the tissue puncture phantom material include 0.3%-0.6% sodium carboxymethyl cellulose, 0.1%-0.3% xanthan gum, 0.3%-1% staghorn tartar gum, 7.6%-8.7% agar, 0.3%-0.6% preservative, and the remainder being purified water.

[0044] In this application, the type of preservative can be selected from a wide range, as long as it is a preservative component that can be used in hydrogels, so that the tissue puncture phantom material is easy to preserve and has a long storage time. Preferably, the preservative includes potassium sorbate.

[0045] In this application, the purified water has low gas content, low impurities, and low bacteria content, which enables the prepared tissue puncture phantom material to be a transparent hydrogel with uniform texture, few air bubbles, easy preservation, and long storage or use time.

[0046] In this application, the sound velocity of the tissue puncture phantom material can be measured using the insertion substitution method in GB / T15261-2008. In some preferred embodiments, the sound velocity of the tissue puncture phantom material is 1530-1550 m / s.

[0047] In this application, the acoustic attenuation coefficient slope of the tissue puncture phantom material can be measured using the insertion substitution method in GB / T15261-2008. In some preferred embodiments, the acoustic attenuation coefficient slope of the tissue puncture phantom material is 0.15 dB / (cm·MHz) - 0.25 dB / (cm·MHz).

[0048] Secondly, this application provides a method for preparing the above-mentioned tissue puncture phantom material, comprising the following steps:

[0049] (1) Mix the raw materials evenly;

[0050] (2) Then heat at 90-100℃ for 30-60 minutes;

[0051] (3) Cooling, and the tissue puncture phantom material is obtained.

[0052] In this application, the temperature is heated to 90-100℃ and maintained for 30-60 minutes. The inventors of this application have found through research that if the heating temperature is too high and the time is too long, the color of the tissue puncture phantom will darken, the amount of flocculent material will increase, and the transparency will be poor, affecting the observation of the puncture path and puncture results under ultrasound. If the heating temperature is too low and the time is too short, the material of the tissue puncture phantom will not be fully melted and mixed, resulting in poor transparency.

[0053] In some preferred embodiments, in step (2), the temperature is maintained at 95°C for 45 minutes.

[0054] The tissue puncture phantom material of this application is transparent and has a certain degree of toughness, good visibility, and can be repeatedly punctured, making it suitable for puncture training.

[0055] Thirdly, this application provides a tissue puncture phantom comprising:

[0056] The outer frame 1 has a certain volume of storage space;

[0057] Simulated skin 2, which is disposed on the upper part of the receiving space within the outer frame 1, is used to simulate the hardness of human skin;

[0058] The tissue puncture phantom material 3 is disposed in the receiving space to simulate the surrounding tissues in the human body and to simulate the imaging of the surrounding tissues in the human body under the processing of the imaging device.

[0059] The simulated lesion 4 is set in the simulated tissue phantom material to simulate lesions in human organs and can be imaged under the processing of imaging equipment.

[0060] Sound-absorbing material 5, which is disposed in the lower part of the receiving space within the outer frame 1, is used to prevent the bottom from reflecting ultrasound.

[0061] In this application, the imaging device can be any imaging device used in the medical field, including but not limited to MRI equipment, ultrasound equipment, and CT equipment.

[0062] In some preferred embodiments, this application provides a tissue puncture phantom comprising:

[0063] The outer frame 1 has a certain volume of storage space;

[0064] Simulated skin 2, which is disposed on the upper part of the receiving space within the outer frame 1, is used to simulate the hardness of human skin;

[0065] The tissue puncture phantom material 3 is placed in the receiving space to simulate the surrounding tissues in the human body, and can simulate the imaging of the surrounding tissues in the human body under the processing of nuclear magnetic resonance and ultrasound equipment.

[0066] The simulated lesion 4 is set in the simulated tissue phantom material to simulate lesions in human organs and can be imaged under ultrasound equipment.

[0067] Sound-absorbing material 5, which is disposed in the lower part of the receiving space within the outer frame 1, is used to prevent the bottom from reflecting ultrasound.

[0068] In some preferred embodiments, as shown in Figure 1, the outer frame 1 consists of a protective cover 11, an upper frame 12, a transparent frame 13, a handle 14, and a base 15. The protective cover 11 needs to be removed from the upper frame 12 during use, and is only placed on the upper frame 12 when not in use or during transportation. The transparent frame 13 is made of transparent PMMA material and is transparent on all four sides, used to observe the internal condition of the phantom and to observe the needle insertion path and the final puncture result during puncture practice. The handle 14 is used for handling, improving the convenience of handling. The base 15 is used to prevent the simulated tissue puncture phantom from tipping over.

[0069] In this application, the simulated skin 2 is used to simulate the real skin of the human body, especially to simulate the hardness of the real skin. The simulated skin includes two components, A and B, wherein component A includes silicone and component B includes a curing agent.

[0070] In this application, the components in the simulated skin are typically mixed and molded at room temperature for 5-16 hours.

[0071] In this application, the main component of the silicone is a mixture of vinyl silicate, the viscosity of the silicone is 8000mPa·s-12000mPa·s, the tear strength is ≥20N / mm, and the elongation is ≥500%.

[0072] In this application, the curing agent may be selected from silane coupling agents or hydrogen-containing polymethylsiloxanes.

[0073] In some preferred embodiments, the mass ratio of components A and B is 1:1 to 1:2. Different ratios result in different molding times and gas content, with 1:1.5 being the most preferred. The applicant has found that when the mass ratio of components A and B is close to 1:1, the molding time is relatively long and the gas content is relatively low; when the mass ratio of components A and B is approximately 1:1.5, the molding time and gas content are optimal; when the mass ratio of components A and B is close to 1:2, the molding time is relatively short, but the gas content is relatively high.

[0074] The applicant also found that when the mass ratio of components A and B is less than 1:2, excessive gas content will affect the sound velocity and observation, and the ultrasonic penetration effect will be poor; when the mass ratio of components A and B is greater than 1:1, the molding time is too long, which will affect the production efficiency.

[0075] In this application, the gas content can be detected by microscopic observation, expressed as the number of bubbles observable per square centimeter. In some preferred embodiments, the gas content of the simulated skin is defined as no more than 20 bubbles per square centimeter (i.e., bubble count ≤ 20 / cm²). 2 In some preferred embodiments, the simulated skin has an air content of no more than 10 bubbles per square centimeter (i.e., bubble count ≤ 10 / cm). 2 ).

[0076] In some preferred embodiments, the thickness of the simulated skin 2 is 3-6 mm. In some more preferred embodiments, the thickness of the simulated skin 2 is 4-5 mm.

[0077] In this application, materials with different components can be used to form different hardnesses. With different hardnesses, the puncture insertion force will vary. The higher the hardness, the greater the initial puncture force. The Shore hardness of the composite of A and B is no greater than 20.

[0078] In this application, the puncture force can be measured by using a three-bladed puncture needle (e.g., a 16G three-bladed puncture needle, purchased from Beijing Medis Medical Technology Co., Ltd.) for puncture and recording the force using a puncture force tester.

[0079] In some preferred embodiments, the puncture force for puncturing the simulated skin is 1-5 N. In some more preferred embodiments, the puncture force for puncturing the simulated skin is 2-4 N.

[0080] In this application, the simulated skin 2 protects the hydrogel in the tissue phantom material 3. The hydrogel has a certain toughness but is relatively brittle, while the simulated skin 2 is relatively tougher and provides some support for the puncture needle. This prevents the hydrogel from being carried out after the needle is inserted into and withdrawn from the simulated skin 2. The simulated skin 2 can recover quickly after the needle is withdrawn, and it has a sealing effect on the hydrogel in the tissue phantom material 3 to prevent excessive hydrogel from being carried out by repeated punctures, which could lead to pores or even needle tracts, negatively affecting ultrasound observation. This also prevents the lifespan of the tissue phantom from being reduced.

[0081] The material of the simulated lesion 4 can be selected from a wide range, as long as the imaging effect is good (such as under imaging equipment such as ultrasound) and the edge image is clear. Silicone is preferred. It is used to simulate lesions in human organs and is suspended in the phantom material. The spacing and size can be adjusted at will. The color and diameter are related to each other, which makes it easy to determine the accuracy of puncture.

[0082] The material of the sound-absorbing material 5 can be selected from a wide range, as long as it can effectively prevent the bottom from reflecting ultrasound and ensure the quality of the simulated lesion imaging. Rubber is preferred. In some preferred embodiments, the surface of the sound-absorbing material 5 is provided with strip-shaped grooves, which can more effectively prevent the bottom from reflecting ultrasound and better ensure the quality of the simulated lesion imaging.

[0083] The present application will be described in detail below through examples. In the following examples, all chemicals are commercially available products.

[0084] In the following embodiments, the air content and puncture force of the simulated skin, the sound velocity and the slope of the sound attenuation coefficient of the TM material were all detected according to the aforementioned method.

[0085] Example 1

[0086] A tissue puncture phantom includes:

[0087] The outer frame 1 has a certain volume of storage space;

[0088] Simulated skin 2, which is disposed on the upper part of the receiving space within the outer frame 1, is used to simulate the hardness of human skin;

[0089] The tissue puncture phantom material 3 is placed in the receiving space to simulate the surrounding tissues in the human body and can simulate the imaging of the surrounding tissues in the human body under MRI and ultrasound.

[0090] The simulated lesion 4 is set in the simulated tissue phantom material to simulate lesions in human organs and can be imaged under ultrasound; the simulated lesion 4 is made of silicone.

[0091] The sound-absorbing material 5 is disposed in the lower part of the receiving space within the outer frame 1 to prevent the bottom from reflecting ultrasound. The sound-absorbing material 5 is made of rubber and has strip-shaped grooves on its surface.

[0092] The outer frame 1 consists of a protective cover 11, an upper frame 12, a transparent frame 13, a handle 14, and a base 15. The protective cover 11 needs to be removed from the upper frame 12 during use, and is only placed on the upper frame 12 when not in use or during transportation. The transparent frame 13 is made of transparent PMMA material, transparent on all four sides, used to observe the internal structure of the phantom and the needle insertion path and final puncture result during puncture practice. The handle 14 is used for handling, improving ease of transport. The base 15 is used to prevent the simulated tissue puncture phantom from tipping over. (See Figure 1.)

[0093] The raw material ratio for simulated skin 2 is as follows: Component A 50.0g, Component B 100.0g.

[0094] Component A is an organosilicone compound, the main component of which is a mixture of vinyl silicate, with a viscosity of 10000 mPa·s, a tear strength of 23 N / mm, and an elongation of 550%; Component B is a silane coupling agent.

[0095] Under this group ratio, the molding time of simulated skin 2 is 6 hours, with a high air content and a bubble count of 14 per cm. 2 See Figure 5; the puncture force is relatively small, at 2.33 N, as shown in Figure 6.

[0096] The raw material ratio of TM material 3 is as follows:

[0097] The preparation methods of TM material 3 include:

[0098] (1) Mix the above ingredients evenly;

[0099] (2) Then heat at 95°C for 30 minutes;

[0100] (3) Cooling, i.e., obtaining TM material.

[0101] The sound velocity of TM material 3 prepared under this ratio is 1530 m / s, and the slope of the sound attenuation coefficient is 0.23 dB / (cm·MHz).

[0102] Example 2

[0103] A tissue puncture phantom is identical to that in Example 1, except for the raw material ratios and preparation methods of the simulated skin 2 and TM material 3.

[0104] The raw material ratio for simulated skin 2 is as follows: Component A 60.0g, Component B 90.0g.

[0105] Component A is an organosilicone compound, the main component of which is a mixture of vinyl silicate, with a viscosity of 8000 mPa·s, a tear strength of 32 N / mm, and an elongation of 500%; Component B is a silane coupling agent.

[0106] Under this group ratio, the molding time of simulated skin 2 is 12 hours, the air content is moderate, and the number of air bubbles is 6 / cm. 2 See Figure 5; the puncture force is moderate, at 3.18 N, as shown in Figure 6.

[0107] Raw material ratio of TM material:

[0108] The preparation methods of TM material 3 include:

[0109] (1) Mix the above ingredients evenly;

[0110] (2) Then heat at 95°C for 45 min;

[0111] (3) Cooling, i.e., obtaining TM material.

[0112] The sound velocity of TM material 3 prepared under this ratio is 1539 m / s, and the slope of the sound attenuation coefficient is 0.19 dB / (cm·MHz). Figures 2 to 4 show the results of measuring the TM material of Example 2.

[0113] Example 3:

[0114] A tissue puncture phantom is identical to that in Example 1, except for the raw material ratios and preparation methods of the simulated skin 2 and TM material 3.

[0115] The raw material ratio for simulated skin 2: Component A 75.0g, Component B 75.0g

[0116] Component A is an organosilicon, whose main component is a mixture of vinyl silicate, with a viscosity of 12000 mPa·s, a tear strength of 42 N / mm, and an elongation of 600%; Component B is a hydrogen-containing polymethylsiloxane.

[0117] Under this group ratio, the molding time for simulated skin 2 was 15 hours, the air content was low, and the number of air bubbles was 1 / cm. 2 See Figure 5; the puncture force was too large, at 3.96 N, as shown in Figure 6.

[0118] Raw material ratio of TM material 3:

[0119] The preparation methods of TM material 3 include:

[0120] (1) Mix the above ingredients evenly;

[0121] (2) Then heat at 100°C for 60 min;

[0122] (3) Cooling, i.e., obtaining TM material.

[0123] The sound velocity of TM material 3 prepared under this ratio is 1550 m / s, and the slope of the sound attenuation coefficient is 0.16 dB / (cm·MHz).

[0124] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of this application and do not constitute a limitation on the content of this application. Although the present application has been described in detail through the above embodiments, those skilled in the art can still make various changes in form and detail based on the technical content described in the content of the invention and the embodiments, without departing from the spirit and scope of this application as defined by the appended claims.

Claims

1. A tissue puncture phantom material, characterized in that, The tissue-mimicking phantom material is a hydrogel, and by mass percentage, its raw materials include 0.2%-0.8% sodium carboxymethyl cellulose, 0.05%-0.5% xanthan gum, 0.2%-1.5% staghorn tartar gum, 7%-12% agar, 0.2%-1% preservative, and the remainder is purified water.

2. The tissue puncture phantom material according to claim 1, characterized in that, The raw materials, by mass percentage, include 0.3%-0.6% sodium carboxymethyl cellulose, 0.1%-0.3% xanthan gum, 0.3%-1% staghorn gum, 7.6%-8.7% agar, 0.3%-0.6% preservatives, and the remainder being purified water.

3. The tissue puncture phantom material according to claim 1, characterized in that, The sound velocity of the simulated tissue puncture phantom material is 1530-1550 m / s.

4. The tissue puncture phantom material according to claim 1, characterized in that, The acoustic attenuation coefficient slope of the simulated tissue puncture phantom material is 0.15dB / (cm·MHz)-0.25dB / (cm·MHz).

5. A method for preparing a tissue puncture phantom material according to any one of claims 1-4, characterized in that, Includes the following steps: (1) Mix the raw materials evenly; (2) Then heat at 90-100℃ for 30-60 minutes; (3) Cooling, and the tissue puncture phantom material is obtained.

6. A tissue puncture phantom, characterized in that, include: The outer frame has a certain volume of storage space; Simulated skin, which is disposed on the upper part of the receiving space within the outer frame, is used to simulate the hardness of human skin; The tissue-simulating phantom material according to any one of claims 1-4 or the tissue-simulating puncture phantom material prepared by the preparation method according to claim 5 is disposed in the receiving space to simulate the surrounding tissues in the human body and to simulate the imaging of the surrounding tissues in the human body under the processing of an imaging device. The simulated lesion is set in the simulated tissue phantom material to simulate lesions in human organs and can be imaged under the processing of imaging equipment; Sound-absorbing material, disposed in the lower part of the receiving space within the outer frame, is used to prevent the bottom from reflecting ultrasound.

7. The tissue puncture phantom according to claim 6, characterized in that, The simulated skin comprises two components, A and B, wherein component A comprises silicone and component B comprises a curing agent.

8. The tissue puncture phantom according to claim 6, characterized in that, The simulated skin has an air content of no more than 20 air bubbles per square centimeter.

9. The tissue puncture phantom according to claim 6, characterized in that, The puncture force for puncturing the simulated skin is 1-5N.

10. The tissue puncture phantom according to claim 6, characterized in that, The thickness of the simulated skin is 3-6 mm.

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