Ultrasonic developing medical material as well as preparation method and application thereof

Abstract

The invention discloses an ultrasonic developing medical material as well as a preparation method and application thereof. The ultrasonic developing medical material is prepared from the following raw material components: a medical polymer material, a hollow filler, a coupling agent and an auxiliary agent. According to the ultrasonic developing medical material, the raw materials are selected, so that the prepared ultrasonic developing medical material has an excellent acoustic impedance value, specifically, the acoustic impedance value of a medical high polymer material is generally small, the hollow filler is in a hollow microbead shape, ultrasonic waves can be effectively reflected due to the existence of micropores, and the ultrasonic developing effect is improved. After the material is added into a medical polymer material, the acoustic impedance value of the material can be remarkably improved, the ultrasonic development effect of the material is further improved, and the material can be applied to manufacturing interventional catheters and implanted devices with the ultrasonic development enhancing effect.

Description

Technical Field

[0001] This invention relates to the field of medical materials technology, specifically to an ultrasound imaging medical material, its preparation method, and its application. Background Technology

[0002] Interventional catheter placement is a common procedure in clinical treatment, and accurate catheter placement is crucial. In recent years, the application of ultrasound-guided catheter interventional procedures in clinical practice has gained increasing attention and expansion. Compared to traditional X-ray catheter placement methods, ultrasound imaging offers advantages such as speed, non-invasiveness, and no radiation. It provides real-time imaging, is simple to perform, and can be done at the bedside. Furthermore, ultrasound-guided catheter interventional procedures can significantly reduce the risk of catheter displacement, decrease the incidence of complications, and thus effectively improve the success rate of the procedure.

[0003] However, due to the difference in acoustic impedance between existing medical interventional catheter materials and human soft tissue (1.52 × 10⁻⁶), the acoustic impedance of these materials is significantly different from that of human soft tissue. 6 kg / m 2 The proximity of ultrasound reflection coefficients to the ultrasound image of existing interventional catheters within the human body makes the images blurry. Therefore, researchers have employed various methods to enhance the ultrasound reflection coefficient of interventional catheters, thereby improving the clarity of ultrasound images of these catheters within the human body.

[0004] Patent CN 104667411A discloses an ultrasonic imaging catheter. The catheter wall is lined with polymer fiber filaments, which overlap and interweave to form a woven mesh layer, creating ultrasonic imaging zones of varying densities between the catheter body and the mesh layer. While this method can enhance the reflection and scattering signals of the catheter wall, the catheter manufacturing process is complex. Furthermore, the woven mesh layer's ability to enhance the reflected and scattered signals is limited. Microbubbles need to be introduced at the fiber intersections to further enhance the ultrasonic echo signal. The introduction of these bubbles requires controlled processing, increasing the manufacturing difficulty.

[0005] Patent US2012 / 0283763A1 enhances the ultrasound imaging effect of interventional devices by coating the surface with an ultrasonic coating. This ultrasonic coating contains polymer particles, which increase the surface roughness of the coating, thereby enhancing the material's ability to scatter and reflect sound waves, thus improving ultrasound imaging. Patent US 2010 / 0239505A1 discloses an ultrasonic coating containing hollow polymer spheres filled with isobutane gas. This gas increases the difference in acoustic impedance between the coating and the surrounding medium, improving ultrasound imaging. However, improving the ultrasound imaging effect of interventional catheters by coating them carries the risk of coating detachment during the intervention process. Furthermore, increasing the surface roughness of the catheter increases the resistance during catheter insertion and removal, and the rough surface also increases the risk of thrombus adhesion.

[0006] Patent CN 107335099A discloses an ultrasonic imaging composite material, its preparation method, and its application. The composite material is mainly composed of a thermoplastic polymer, inorganic powder, dispersant, and antioxidant. The acoustic impedance of the inorganic powder is more than three times that of the thermoplastic polymer. The inorganic powder is selected from aluminum oxide, titanium dioxide, and silicon dioxide. However, the high density and high filling ratio of metal compounds significantly affect the physical properties of the material.

[0007] In summary, existing methods for enhancing the ultrasonic imaging effect of catheter materials often require complex processing techniques, are costly, significantly impact material properties, and pose a risk of coating peeling. Therefore, there is an urgent need to prepare materials with good ultrasonic imaging effects at a reasonable cost and with simple processing techniques to meet the manufacturing and usage requirements of medical interventional catheters and implantable devices. Summary of the Invention

[0008] The purpose of this invention is to provide an ultrasound-enhancing medical material, its preparation method, and its application. This invention obtains a medical material with excellent ultrasound imaging effect by using a hollow filler blending method. This material can be used to manufacture interventional catheters and implantable devices with enhanced ultrasound imaging effect.

[0009] In order to achieve the above-mentioned objectives of the present invention, the following technical solution is adopted:

[0010] The first aspect of this invention provides an ultrasonic imaging medical material, the ultrasonic imaging medical material comprising the following raw material components:

[0011] Medical polymer materials, hollow fillers, coupling agents and additives.

[0012] Preferably, the ultrasound imaging medical material comprises the following raw material components in parts by weight:

[0013] The composition includes 90-110 parts of medical polymer material, 2-50 parts of hollow filler, 0.01-0.25 parts of coupling agent, and 0.01-0.05 parts of auxiliary agent.

[0014] Preferably, the medical polymer material is selected from at least one of polyethylene, polypropylene, polycarbonate, polyvinyl chloride, polyurethane, polyamide, silicone rubber, polyester, polyoxymethylene, polyphenylene ether and polyetheretherketone.

[0015] Preferably, the hollow filler is silicate hollow microspheres; the silicate hollow microspheres include aluminosilicate hollow glass microspheres and borosilicate glass hollow microspheres.

[0016] Preferably, the hollow filler has a particle size of 2–130 μm and a wall thickness of 1–10 μm.

[0017] Preferably, the coupling agent is selected from at least one of silane coupling agents, titanate coupling agents, aluminate coupling agents, and zirconate coupling agents.

[0018] Preferably, the adjuvant includes an antioxidant; the antioxidant is antioxidant 1010 and / or antioxidant 168.

[0019] Preferably, the additives also include lubricants.

[0020] A second aspect of the present invention provides a method for preparing the above-mentioned ultrasound-enhancing medical material, the method comprising the following steps:

[0021] (a) A surface modification of a hollow filler is performed using a coupling agent to obtain a modified hollow filler;

[0022] (b) The medical polymer, auxiliaries and modified hollow filler are mixed and melt-blended, extruded, cooled and pelletized to obtain the ultrasonic imaging medical material.

[0023] Preferably, the melt blending temperature is 145–165°C.

[0024] A third aspect of the present invention provides the application of the aforementioned ultrasound-detectable medical material in the preparation of medical interventional catheters or implantable devices with ultrasound-detectable effects.

[0025] Compared with the prior art, the beneficial effects of the present invention include at least the following:

[0026] The ultrasonic imaging medical material of this invention, through the selection of various raw materials, produces an ultrasonic imaging medical material with excellent acoustic impedance value. Specifically, the acoustic impedance value of medical polymer materials is generally low, while the hollow filler is in the form of hollow microspheres. Due to the presence of micropores, it can effectively reflect ultrasonic waves. Adding it to the medical polymer material can significantly increase the acoustic impedance value of the material, thereby improving its ultrasonic imaging effect. The coupling agent added in this invention is to improve the compatibility between the medical polymer material and the hollow filler. The auxiliary agents include lubricants, antioxidants, etc., where the lubricant improves the processing performance of the material, and the antioxidant prevents the aging of the material during processing and use. Attached Figure Description

[0027] To more clearly illustrate the specific embodiments of the present invention or the technical solutions in the prior art, the accompanying drawings used in the description of the specific embodiments or the prior art will be briefly introduced below. In all the drawings, similar elements or parts are generally identified by similar reference numerals. In the drawings, the elements or parts are not necessarily drawn to scale.

[0028] Figure 1The image shows an ultrasound image of a common medical catheter in pork used in Comparative Example 1 of this invention.

[0029] Figure 2 The image shows an ultrasound image of a medical catheter in pork from Example 3 of the present invention.

[0030] Figure 3 This is an ultrasound image of a medical catheter used in Example 4 of the present invention, which is made from pork. Detailed Implementation

[0031] The embodiments of the technical solution of the present invention will be described in detail below with reference to the examples. The following embodiments are only used to illustrate the technical solution of the present invention more clearly, and are therefore only examples, and should not be used to limit the scope of protection of the present invention.

[0032] It should be noted that, unless otherwise stated, the technical or scientific terms used in this application should have the ordinary meaning as understood by one of ordinary skill in the art to which this invention pertains.

[0033] The first aspect of this invention provides an ultrasonic imaging medical material, the ultrasonic imaging medical material comprising the following raw material components:

[0034] Medical polymer materials, hollow fillers, coupling agents and additives.

[0035] Preferably, the ultrasound imaging medical material comprises the following raw material components in parts by weight:

[0036] The composition includes 90-110 parts of medical polymer material, 2-50 parts of hollow filler, 0.01-0.25 parts of coupling agent, and 0.01-0.05 parts of auxiliary agent.

[0037] The ultrasonic imaging medical material of this invention, through the selection of various raw materials, produces an ultrasonic imaging medical material with excellent acoustic impedance value. Specifically, the acoustic impedance value of medical polymer materials is generally low, while the hollow filler is in the form of hollow microspheres. Due to the presence of micropores, it can effectively reflect ultrasonic waves. Adding it to the medical polymer material can significantly increase the acoustic impedance value of the material, thereby improving its ultrasonic imaging effect. The coupling agent added in this invention is to improve the compatibility between the medical polymer material and the hollow filler. The auxiliary agents include lubricants, antioxidants, etc., where the lubricant improves the processing performance of the material, and the antioxidant prevents the aging of the material during processing and use.

[0038] In some embodiments, the medical polymer material is selected from at least one of polyethylene, polypropylene, polycarbonate, polyvinyl chloride, polyurethane, polyamide, silicone rubber, polyester, polyoxymethylene, polyphenylene ether, and polyetheretherketone.

[0039] In some embodiments, the medical polymer material is selected from at least one of polyethylene, polyvinyl chloride, polyurethane, polyamide, and silicone rubber;

[0040] In one embodiment, the medical polymer material is polyurethane, specifically an aromatic polyether polyurethane.

[0041] In some embodiments, the hollow filler is silicate hollow microspheres; the silicate hollow microspheres include aluminosilicate hollow glass microspheres and borosilicate glass hollow microspheres.

[0042] In some embodiments, the particle size of the hollow filler can be 2 to 130 μm, and the wall thickness can be 1 to 10 μm.

[0043] In some embodiments, the coupling agent is selected from at least one of silane coupling agents, titanate coupling agents, aluminate coupling agents, and zirconate coupling agents.

[0044] In some embodiments, the adjuvant includes an antioxidant; the antioxidant is antioxidant 1010 and / or antioxidant 168.

[0045] In some embodiments, the additives also include lubricants.

[0046] Another embodiment of the present invention provides a method for preparing the above-mentioned ultrasound-enhancing medical material, the method comprising the following steps:

[0047] (a) A surface modification of a hollow filler is performed using a coupling agent to obtain a modified hollow filler;

[0048] (b) The medical polymer, auxiliaries and modified hollow filler are mixed and melt-blended, extruded, cooled and pelletized to obtain the ultrasonic imaging medical material.

[0049] In one embodiment, the melt blending temperature is 145–165°C.

[0050] Another embodiment of the present invention provides the application of the ultrasound-detectable medical material in the preparation of medical interventional catheters or implantable devices with ultrasound-detectable effects.

[0051] The technical solution of the present invention will be further described in detail below through specific embodiments.

[0052] Example 1

[0053] This embodiment is an ultrasonic imaging medical material, which comprises the following raw material components in parts by weight:

[0054] 95 parts of medical polymer material, 5 parts of hollow filler, 0.025 parts of coupling agent and 0.03 parts of additives;

[0055] Among them, the medical polymer material is polyurethane 85A and PE wax with a mass ratio of 93:2;

[0056] The hollow filler is borosilicate glass hollow microspheres, 3M hollow glass microspheres iM16K (standard median particle size 20μm, compressive strength 110.32MPa, wall thickness 0.5~1.5μm, standard density 0.46g / mL);

[0057] The coupling agent is KH-560;

[0058] The additives are antioxidants; the antioxidants are antioxidant 1010 and antioxidant 168 in a mass ratio of 1:2.

[0059] The preparation method of the above-mentioned ultrasound-enhancing medical material includes the following steps:

[0060] (a) 50μm hollow glass microspheres were put into a high-speed mixer, coupling agent KH-560 was added, and the mixture was stirred at a speed of 3000rpm for 5min to obtain a modified hollow filler.

[0061] (b) The medical polymer, additives and modified hollow filler are mixed and fed into the granulation unit of a φ26 twin-screw extruder. The operating parameters are: first stage heating 145°C, second stage heating 150°C, third stage heating 155°C, fourth stage heating 160°C, die head heating 165°C, screw speed 450 rpm, and cooling water temperature 16°C for melt blending, extrusion molding, cooling and pelletizing to obtain the ultrasonic imaging medical material.

[0062] Example 2

[0063] This embodiment is an ultrasonic imaging medical material, which comprises the following raw material components in parts by weight:

[0064] 90 parts of medical polymer material, 10 parts of hollow filler, 0.05 parts of coupling agent and 0.03 parts of auxiliary agent;

[0065] Among them, the medical polymer material is polyurethane 85A and PE wax in a mass ratio of 87:3;

[0066] The hollow filler is borosilicate glass hollow microspheres, 3M hollow glass microspheres iM16K (standard median particle size 20μm, compressive strength 110.32MPa, wall thickness 0.5~1.5μm, standard density 0.46g / mL);

[0067] The coupling agent is KH-560;

[0068] The additives are antioxidants; the antioxidants are antioxidant 1010 and antioxidant 168 in a mass ratio of 1:2.

[0069] The preparation method of the above-mentioned ultrasound-enhancing medical material includes the following steps:

[0070] (a) 50μm hollow glass microspheres were put into a high-speed mixer, coupling agent KH-560 was added, and the mixture was stirred at a speed of 3000rpm for 5min to obtain a modified hollow filler.

[0071] (b) The medical polymer, additives and modified hollow filler are mixed and fed into the granulation unit of a φ26 twin-screw extruder. The operating parameters are: first stage heating 145°C, second stage heating 150°C, third stage heating 155°C, fourth stage heating 160°C, die head heating 165°C, screw speed 450 rpm, and cooling water temperature 16°C for melt blending, extrusion molding, cooling and pelletizing to obtain the ultrasonic imaging medical material.

[0072] Example 3

[0073] This embodiment describes a method for preparing an ultrasound-detectable medical catheter, which includes the following steps:

[0074] The ultrasonic imaging medical material prepared in Example 1 was fed into a single-screw medical catheter extruder. The operating parameters were as follows: first stage heating 155°C, second stage heating 165°C, third stage heating 175°C, fourth stage heating 175°C, die head heating 170°C, die heating 165°C, screw speed 35 rpm, and cooling water temperature 16°C. After melting and plasticizing, extrusion, die shaping, cooling and cutting, the ultrasonic imaging medical catheter was finally obtained.

[0075] Example 4

[0076] This embodiment describes a method for preparing an ultrasound-detectable medical catheter, which includes the following steps:

[0077] The ultrasonic imaging medical material prepared in Example 2 was fed into a single-screw medical catheter extruder. The operating parameters were as follows: first stage heating 155°C, second stage heating 165°C, third stage heating 175°C, fourth stage heating 175°C, die head heating 170°C, die heating 165°C, screw speed 35 rpm, and cooling water temperature 16°C. After melting and plasticizing, extrusion, die shaping, cooling and cutting, the ultrasonic imaging medical catheter was finally obtained.

[0078] Comparative Example 1

[0079] This comparative example illustrates a method for preparing a common medical catheter, which includes the following steps:

[0080] Ordinary TPU 85A granules are fed into a single-screw medical catheter extruder with the following operating parameters: first stage heating 155℃, second stage heating 165℃, third stage heating 175℃, fourth stage heating 175℃, die head heating 170℃, die heating 165℃, screw speed 35 rpm, and cooling water temperature 16℃. After melting and plasticizing, extrusion, die shaping, cooling and cutting, ordinary medical catheters are finally obtained.

[0081] Experimental Example

[0082] Use pork belly with skin, with a thickness of 60mm; use a low frequency of 3.5–5.0 GHz;

[0083] The specific experimental method involved placing a medical catheter under the pork and performing an ultrasound scan to obtain an ultrasound image.

[0084] An ultrasound scan was performed on a conventional medical catheter prepared in Comparative Example 1. The ultrasound images are as follows: Figure 1 As shown;

[0085] The ultrasound-enhancing medical catheter prepared in Example 3 was subjected to ultrasound scanning, and the ultrasound images are as follows: Figure 2 As shown;

[0086] The ultrasound-enhancing medical catheter prepared in Example 4 was subjected to ultrasound scanning, and the ultrasound images are as follows: Figure 3 As shown;

[0087] Depend on Figures 1-3 It can be known that:

[0088] Compared to the comparative example, the ultrasound-enhanced medical catheter of this application has better imaging effect and clearer images.

[0089] Finally, it should be noted that the above embodiments are only used to illustrate the technical solutions of the present invention, and not to limit them. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention, and they should all be covered within the scope of the claims and specification of the present invention.

Claims

1. A medical material for ultrasound imaging, characterized in that, The ultrasound-enhancing medical material comprises the following raw material components: Medical polymer materials, hollow fillers, coupling agents and additives.

2. The ultrasonic imaging medical material according to claim 1, characterized in that, The ultrasound imaging medical material comprises the following raw material components in parts by weight: The composition includes 90-110 parts of medical polymer material, 2-50 parts of hollow filler, 0.01-0.25 parts of coupling agent, and 0.01-0.05 parts of auxiliary agent.

3. The ultrasonic imaging medical material according to claim 1 or 2, characterized in that, The medical polymer material is selected from at least one of polyethylene, polypropylene, polycarbonate, polyvinyl chloride, polyurethane, polyamide, silicone rubber, polyester, polyoxymethylene, polyphenylene ether, and polyetheretherketone.

4. The ultrasonic imaging medical material according to claim 1 or 2, characterized in that, The hollow filler is silicate hollow microspheres; the silicate hollow microspheres include aluminosilicate hollow glass microspheres and borosilicate glass hollow microspheres.

5. The ultrasonic imaging medical material according to claim 1 or 2, characterized in that, The hollow filler has a particle size of 2–130 μm and a wall thickness of 1–10 μm.

6. The ultrasonic imaging medical material according to claim 1 or 2, characterized in that, The coupling agent is selected from at least one of silane coupling agents, titanate coupling agents, aluminate coupling agents, and zirconate coupling agents.

7. The ultrasonic imaging medical material according to claim 1 or 2, characterized in that, The adjuvant includes an antioxidant; the antioxidant is antioxidant 1010 and / or antioxidant 168.

8. The method for preparing the ultrasonic imaging medical material according to any one of claims 1 to 7, characterized in that, The preparation method includes the following steps: (a) A surface modification of a hollow filler is performed using a coupling agent to obtain a modified hollow filler; (b) The medical polymer, auxiliaries and modified hollow filler are mixed and melt-blended, extruded, cooled and pelletized to obtain the ultrasonic imaging medical material.

9. The preparation method according to claim 8, characterized in that, The melt blending temperature is 145–165°C.

10. The use of the ultrasound-detectable medical material according to any one of claims 1 to 7 in the preparation of medical interventional catheters or implantable devices with ultrasound-detectable effects.

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