Balloon plugging device for ultrasonic 3D printing

Abstract

The invention provides a balloon plugging device for ultrasonic 3D printing, which comprises a multi-cavity catheter, the multi-cavity catheter comprises an outer layer protective sleeve, an inflation catheter and an ink delivery pipe, the inflation catheter and the ink delivery pipe are located in the outer layer protective sleeve, and the axes of the outer layer protective sleeve, the inflation catheter and the ink delivery pipe are parallel; the outer-layer protective sleeve is provided with a first sealing face and a second sealing face which are perpendicular to the axis, the first sealing face is the front end face of the outer-layer protective sleeve, the second sealing face is located at one end close to the front end face of the outer-layer protective sleeve, and the position, between the first sealing face and the second sealing face, of the outer-layer protective sleeve is connected with a pneumatic balloon. The pneumatic balloon is communicated with a cavity between the first sealing surface and the second sealing surface; the front end of the inflation catheter is communicated with the pneumatic balloon, and the front end of the ink conveying pipe extends out of the first sealing face. Blood flow and uncured acoustic ink can be physically isolated through the pneumatic balloon, the ink is prevented from being washed away by the blood flow, and meanwhile, hydrogel particles of the acoustic ink are prevented from entering blood to cause thrombus.

Description

Technical Field

[0001] This invention belongs to the field of ultrasonic 3D printing technology and relates to an ultrasonic 3D printing occlusion balloon device. Background Technology

[0002] Ultrasonic 3D printing technology is an emerging research direction in the fields of biomanufacturing and clinical tissue engineering in recent years. Its core principle is to use the acoustic radiation force of an ultrasonic field to drive functional ink materials to precisely deposit and shape in the target area, ultimately achieving in-situ construction of tissue, organ models, or implants. Acoustic ink is a hydrogel material used for ultrasonic 3D printing. Its main components are poly(N-isopropyl acrylamide) (PNIPAM), polyethylene glycol diacrylate (PEGDA), and agar. Among them, PNIPAM is a phase change material that changes from liquid to solid at temperatures above 32°C, causing the entire acoustic ink to change from a liquid to a viscous and difficult-to-flow state, which is used to suppress the acoustic flow effect.

[0003] In ultrasonic 3D printing, acoustic ink is delivered to the target printing area via a catheter. The target printing area for in-situ printing is often living tissue perfused with blood (such as the surface of damaged organs or the interior of blood vessels). Existing acoustic inks lack the ability to resist erosion in a blood-flow environment. On the one hand, uncured acoustic ink is easily washed away by the blood flow upon contact, failing to deposit and form properly in the target area, resulting in a significant decrease in printing efficiency and accuracy. On the other hand, the lost hydrogel particles, once in the bloodstream, become foreign bodies, activating the coagulation system and potentially causing thrombosis, posing a serious clinical safety hazard. Summary of the Invention

[0004] To address the problem of insufficient resistance to erosion in the blood flow environment during the delivery of existing acoustic inks, this invention provides an occlusion balloon device for ultrasonic 3D printing.

[0005] This invention is achieved through the following technical solution: An ultrasonic 3D printing occlusion balloon device includes: a multi-cavity conduit, the multi-cavity conduit including an outer protective sleeve and an inflation conduit and an ink delivery conduit located inside the outer protective sleeve, the axes of the outer protective sleeve, the inflation conduit and the ink delivery conduit being parallel; the outer protective sleeve has a first sealing surface and a second sealing surface perpendicular to the axis, the first sealing surface being the front end face of the outer protective sleeve, the second sealing surface being located at one end near the front end face of the outer protective sleeve, an air-operated balloon being connected to the outer protective sleeve between the first sealing surface and the second sealing surface, the air-operated balloon communicating with the cavity between the first sealing surface and the second sealing surface; the front end of the inflation conduit communicating with the air-operated balloon, and the front end of the ink delivery conduit extending beyond the first sealing surface.

[0006] Preferably, the ink delivery tube is fitted with an insulated conduit, and the distal end of the insulated conduit is connected to an inlet pipe and an outlet pipe.

[0007] Furthermore, the ultrasonic 3D printing occlusion balloon device also includes a cryogenic medium storage tank, which is used to hold sterile physiological saline at 4~10℃; the inlet end of the inlet pipe and the outlet end of the outlet pipe are both connected to the cryogenic medium storage tank.

[0008] Furthermore, a temperature monitor is installed on the liquid outlet pipeline.

[0009] Preferably, the outer protective sleeve has an X-ray imaging ring at the front end.

[0010] Furthermore, the X-ray imaging ring is made of a platinum-iridium alloy.

[0011] Preferably, the ultrasonic 3D printing occlusion balloon device further includes a gas path switching valve, a gas storage tank, and a vacuum pump; the distal end of the inflation conduit is connected to a gas pipeline, the other end of the gas pipeline is connected to the first port of the gas path switching valve, the second port of the gas path switching valve is connected to the gas storage tank, and the third port of the gas path switching valve is connected to the vacuum pump.

[0012] Furthermore, a gas filling / discharging valve is provided on the gas pipeline.

[0013] Furthermore, a pressure monitor is installed on the gas pipeline.

[0014] Furthermore, the ultrasonic 3D printing occlusion balloon device also includes an ink tank, the distal end of which is connected to the ink tank via an ink pipeline, and the ink pipeline is equipped with a flow regulating valve and an ink delivery pump.

[0015] Compared with the prior art, the present invention has the following beneficial effects: This invention relates to an occlusion balloon device for ultrasonic 3D printing. An inflation conduit and a pneumatic balloon are housed within a multi-lumen conduit. When the front end of the multi-lumen conduit is delivered to the target printing area within the body, the pneumatic balloon is inflated through the inflation conduit, causing it to rapidly expand and tightly adhere to the inner wall of the tissue (e.g., the inner wall of the left atrial appendage, blocking the opening of the left atrial appendage). This forms a closed printing chamber at the front end of the multi-lumen conduit. Acoustic ink is then delivered through an ink delivery tube. The pneumatic balloon physically isolates the blood flow from the uncured acoustic ink, preventing the ink from being washed away by the bloodstream. The acoustic ink retention rate is increased to over 95%, and the printing accuracy error is controlled within 5%. Simultaneously, it avoids the entry of hydrogel particles from the acoustic ink into the bloodstream, preventing thrombosis. Animal experiments have verified that the thrombosis incidence rate is reduced to below 1%. After printing, the pneumatic balloon rapidly deflates and contracts, leaving no foreign matter residue.

[0016] Furthermore, the present invention provides an insulated conduit over the ink delivery tube. By introducing a cooling medium into the interlayer between the insulated conduit and the ink delivery tube, the acoustic ink is kept below its corresponding phase change temperature. This significantly slows down the heating rate of the acoustic ink by human body temperature, ensuring that the acoustic ink maintains good liquid flow characteristics throughout its journey from the conduit inlet to the target printing area. This completely eliminates the problem of conduit blockage caused by phase change solidification of components in the acoustic ink induced by body temperature.

[0017] Furthermore, by setting an X-ray imaging ring at the front end of the outer protective sleeve, the present invention can detect the position of the front end of the multi-cavity catheter using X-rays, determine the position of the acoustic ink, and ensure accurate arrival at the target printing area. At the same time, the detected position is synchronized to the ultrasonic 3D printing equipment, guiding the ultrasonic 3D printing equipment to accurately focus on the front of the multi-cavity catheter and the target printing area, ensuring that the ultrasonic focus is always in the acoustic ink during printing. When applied to left atrial appendage printing, it can solve the problems of positioning ambiguity and ultrasonic energy focusing deviation caused by the complex anatomical structure of the left atrial appendage, and improve printing accuracy. Attached Figure Description

[0018] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the description of the embodiments or the prior art will be briefly introduced below. Obviously, the drawings described below are some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort.

[0019] Figure 1 This is a schematic diagram of the radial cross-section of the multi-cavity catheter in the ultrasonic 3D printing occlusion balloon device of the present invention (pneumatic balloon inflated state). Figure 2 This is a front view of the multi-lumen catheter in the ultrasonic 3D printing occlusion balloon device of the present invention (pneumatic balloon inflated state). Figure 3This is a schematic diagram of the tubing connection of the occlusion balloon device for ultrasonic 3D printing of the present invention.

[0020] In the diagram: 1 is the outer protective sleeve, 2 is the inflation conduit, 3 is the ink delivery conduit, 4 is the X-ray imaging ring, 5 is the heat preservation conduit, 6 is the pneumatic balloon, 7 is the cryogenic medium storage tank, 8 is the circulation pump, 9 is the temperature monitor, 10 is the gas path switching valve, 11 is the gas storage tank, 12 is the vacuum pump, 13 is the pressure monitor, 14 is the inflation / deflation valve, 15 is the ink storage tank, 16 is the flow regulating valve, and 17 is the ink delivery pump. Detailed Implementation

[0021] The following specific examples illustrate the implementation of the present invention. Those skilled in the art can easily understand other advantages and effects of the present invention from the content disclosed in this specification. The present invention can also be implemented or applied through other different specific embodiments, and various details in this specification can also be modified or changed based on different viewpoints and applications without departing from the spirit of the present invention.

[0022] It should be noted that the process equipment or apparatus not specifically mentioned in the following embodiments are all conventional equipment or apparatus in the art.

[0023] It should be noted that the terms "comprising" and "having," and any variations thereof, are intended to cover non-exclusive inclusion. For example, a process, method, system, product, or apparatus that includes a series of steps or units is not necessarily limited to those steps or units explicitly listed, but may include other steps or units not explicitly listed or inherent to these processes, methods, products, or apparatuses. Furthermore, unless otherwise stated, the numbering of each method step is merely a convenient tool for identifying each method step, and not intended to limit the order of the method steps or define the scope of the invention. Changes or adjustments to their relative relationships, without substantially altering the technical content, should also be considered within the scope of the invention.

[0024] In addition, it should be noted that the terms "front end" and "rear end" in this invention are determined with reference to the direction of travel when the multi-lumen catheter is inserted into the body.

[0025] refer to Figure 1 and Figure 2The occlusion balloon device for ultrasonic 3D printing of the present invention includes: a multi-cavity conduit; the multi-cavity conduit includes an outer protective sleeve 1 and an inflation conduit 2 and an ink delivery tube 3 located inside the outer protective sleeve 1, the axes of the outer protective sleeve 1, the inflation conduit 2 and the ink delivery tube 3 are parallel; the outer protective sleeve 1 has a first sealing surface and a second sealing surface perpendicular to the axis, the first sealing surface is the front end face of the outer protective sleeve 1, the second sealing surface is located at one end close to the front end face of the outer protective sleeve 1, a pneumatic balloon 6 is connected to the outer protective sleeve 1 between the first sealing surface and the second sealing surface, the pneumatic balloon 6 communicates with the cavity between the first sealing surface and the second sealing surface; the front end of the inflation conduit 2 communicates with the pneumatic balloon 6, and the front end of the ink delivery tube 3 extends out of the first sealing surface.

[0026] The multi-lumen catheter of this invention is provided with an inflation catheter 2 and a pneumatic balloon 6. When the front end of the multi-lumen catheter is delivered to the target printing area in the body, the pneumatic balloon 6 is inflated through the inflation catheter 2, driving the pneumatic balloon 6 to expand rapidly and closely fit the inner wall of the tissue (e.g., the inner wall of the left atrial appendage, blocking the opening of the left atrial appendage), forming a closed printing chamber at the front end of the multi-lumen catheter. At this time, acoustic ink is delivered through the ink delivery tube 3, so that the pneumatic balloon 6 can physically isolate the blood flow from the uncured acoustic ink. After printing, the pneumatic balloon 6 is quickly deflated and contracted, leaving no foreign matter residue, which not only prevents the ink from being washed away by the blood flow, but also prevents hydrogel particles from entering the blood and causing thrombosis.

[0027] Because some components in commonly used acoustic inks, such as PNIPAM, have a phase transition critical temperature (approximately 32°C) that is significantly lower than normal human body temperature (36.5~37.5°C), the acoustic ink is rapidly heated by the human body temperature during delivery through the conduit. When the temperature of the acoustic ink rises above 32°C, PNIPAM undergoes a phase transition and solidifies, causing the viscosity of the entire hydrogel system to increase sharply. This results in blockage within the conduit and loss of flowability, preventing the ink from reaching the target printing area and directly causing the printing operation to fail.

[0028] To prevent the acoustic ink temperature from exceeding the corresponding phase transition temperature, in some preferred embodiments of the present invention, the ink delivery pipe 3 is fitted with an insulated conduit 5, the distal end of which is connected to an inlet pipe and an outlet pipe. Specifically, a cryogenic medium storage tank 7 can be provided, which is used to hold sterile physiological saline at 4~10℃ as a cooling medium; the inlet end of the inlet pipe and the outlet end of the outlet pipe are both connected to the cryogenic medium storage tank 7, and a circulation pump 8 is provided on the inlet pipe to realize the circulation of the cooling medium. In some embodiments of the present invention, a temperature monitor 9 can also be provided on the outlet pipe to detect the temperature of the circulating cooling medium in real time, so as to ensure that the temperature of the acoustic ink is maintained below the phase transition temperature.

[0029] This invention introduces a cooling medium into the interlayer between the heat-insulating conduit 5 and the ink delivery conduit 3, keeping the acoustic ink below its corresponding phase change temperature. This significantly slows down the heating rate of the acoustic ink by human body temperature, ensuring that the acoustic ink maintains good liquid flow characteristics throughout its journey from the conduit inlet to the target printing area. It completely eliminates the problem of conduit blockage caused by phase change and solidification of components in the acoustic ink induced by body temperature, effectively overcoming the technical defects of existing external heat preservation solutions, which are complex to operate, only treat the symptoms, and cannot fundamentally solve the problem of premature phase change.

[0030] In practice, the temperature of the cooling medium can be adjusted according to the composition of the acoustic ink used. For example, for PNIPAM-PEGDA-agar-based acoustic ink, the temperature of the acoustic ink is maintained at 25-30℃, which is lower than the phase transition critical temperature of PNIPAM (32℃).

[0031] The ultrasonic 3D printing process relies on the focus of the ultrasonic field to rapidly heat the acoustic ink material, and it is crucial to keep the focus within the acoustic ink material. However, acoustic ink is a hydrogel material, and its acoustic / X-ray imaging properties are similar to those of the human body, making it impossible to observe the location of the acoustic ink in the body using conventional digital subtraction angiography (DSA) and ultrasound equipment in the interventional operating room.

[0032] To accurately observe the position of the acoustic ink within the body, in some preferred embodiments of the present invention, the front end of the outer protective sleeve 1 is provided with an X-ray imaging ring 4, the material of which is preferably a platinum-iridium alloy.

[0033] This invention, by setting an X-ray imaging ring 4 at the front end of the outer protective sleeve 1, can detect the position of the front end of the multi-cavity catheter using X-rays, determine the position of the acoustic ink, and ensure accurate arrival at the target printing area. At the same time, the detected position is synchronized to the ultrasonic 3D printing equipment, guiding the ultrasonic 3D printing equipment to accurately focus on the front of the multi-cavity catheter and the target printing area, ensuring that the ultrasonic focus is always in the acoustic ink during printing. When applied to printing the left atrial appendage, it can solve the problems of positioning ambiguity and ultrasonic energy focusing deviation caused by the complex anatomical structure of the left atrial appendage, and improve printing accuracy.

[0034] like Figure 3As shown, in some preferred embodiments of the present invention, the ultrasonic 3D printing occlusion balloon device further includes a gas path switching valve 10, a gas storage tank 11, and a vacuum pump 12; the distal end of the inflation conduit 2 is connected to a gas pipeline, the other end of the gas pipeline is connected to the first port of the gas path switching valve 10, the second port of the gas path switching valve 10 is connected to the gas storage tank 11, and the third port of the gas path switching valve 10 is connected to the vacuum pump 12. Furthermore, an inflation / deflation valve 14 and / or a pressure monitor 13 may also be installed on the gas pipeline.

[0035] This invention allows for convenient switching of the connection between the inflation conduit 2, the gas storage tank 11, and the vacuum pump 12 via the gas path switching valve 10. When printing is required, the inflation conduit 2 is switched to connect with the gas storage tank 11 via the gas path switching valve 10, and the inflation / deflation valve 14 is opened, allowing the gas in the gas storage tank 11 to enter the pneumatic balloon 6 through the inflation conduit 2, causing the pneumatic balloon 6 to expand and form a sealed printing environment. After printing is completed, the inflation conduit 2 is switched to connect with the vacuum pump 12 via the gas path switching valve 10, and the vacuum pump 12 deflates the gas, causing the pneumatic balloon 6 to quickly deflate and contract, facilitating the removal of the device from the body.

[0036] The left atrial appendage is an ear-shaped protrusion on the outer side of the left atrium. Its surface is uneven, and blood flow is slow, making it a high-risk area for thrombosis. When used in the left atrial appendage, the expansion pressure of the pneumatic balloon 6 in this invention must be adapted to the tolerance of the left atrial appendage tissue (generally not exceeding 20 mmHg). Therefore, this invention uses a pressure monitor 13 to monitor the expansion pressure of the pneumatic balloon 6 in real time (ensuring it does not exceed the tolerance threshold of the left atrial appendage tissue) to avoid tissue damage.

[0037] like Figure 3 As shown, in some preferred embodiments of the present invention, the ultrasonic 3D printing occlusion balloon device further includes an ink tank 15. The distal end of the ink delivery pipe 3 is connected to the ink tank 15 via an ink pipeline. The ink pipeline is provided with a flow regulating valve 16 and an ink delivery pump 17, and the flow rate of the ink is regulated by the flow regulating valve 16.

[0038] In some embodiments of the present invention, the outer protective sleeve 1 may be made of medical-grade silicone with a thickness of 0.2-0.3 mm; the inflatable conduit 2 may be made of polyetheretherketone (PEEK) with a diameter of 0.5-0.6 mm; the ink delivery tube 3 may be made of polytetrafluoroethylene (PTFE) with a diameter of 1-1.2 mm; the X-ray imaging ring may be 0.1-0.2 mm thick and 1-2 mm wide; the interlayer width between the heat-insulating conduit 5 and the ink delivery tube 3 may be 0.3-0.4 mm; the pneumatic balloon 6 may be made of medical-grade polyurethane (PU), which is spindle-shaped in the contracted state with a diameter of 2-3 mm, and the diameter in the expanded state is designed to be 15-25 mm according to the compatibility with the left atrial appendage; the gas storage tank 11 is preferably a sterile gas storage tank 11.

[0039] Example In this embodiment, the occlusion balloon device for ultrasonic 3D printing includes: a multi-cavity conduit, the multi-cavity conduit including an outer protective sleeve 1 and an inflation conduit 2 and an ink delivery tube 3 located inside the outer protective sleeve 1, the axes of the outer protective sleeve 1, the inflation conduit 2 and the ink delivery tube 3 are parallel; the outer protective sleeve 1 has a first sealing surface and a second sealing surface perpendicular to the axis, the first sealing surface is the front end face of the outer protective sleeve 1, the second sealing surface is located at one end close to the front end face of the outer protective sleeve 1, a pneumatic balloon 6 is connected to the outer protective sleeve 1 between the first sealing surface and the second sealing surface, the pneumatic balloon 6 communicates with the cavity between the first sealing surface and the second sealing surface; the front end of the inflation conduit 2 communicates with the pneumatic balloon 6, and the front end of the ink delivery tube 3 extends out of the first sealing surface.

[0040] The distal end of the inflation conduit 2 is connected to a gas pipeline, the other end of which is connected to the first port of a gas switching valve 10. The second port of the gas switching valve 10 is connected to a gas storage tank 11, and the third port of the gas switching valve 10 is connected to a vacuum pump 12. An inflation / deflation valve 14 and a pressure monitor 13 are installed on the gas pipeline. The distal end of the ink delivery pipe 3 is connected to an ink storage tank 15 via an ink pipeline, which is equipped with a flow regulating valve 16 and an ink delivery pump 17.

[0041] The ink delivery pipe 3 is fitted with an insulated conduit 5, and the distal end of the insulated conduit 5 is connected to an inlet pipe and an outlet pipe. The inlet end of the inlet pipe and the outlet end of the outlet pipe are both connected to a cryogenic medium storage tank 7. A circulation pump 8 and a temperature monitor 9 are installed on the inlet pipe.

[0042] The outer protective sleeve 1 has an X-ray imaging ring 4 at its front end, and the X-ray imaging ring 4 is made of platinum-iridium alloy.

[0043] This embodiment forms a synergistic closed loop of "imaging and positioning → balloon sealing → warm delivery → ultrasonic printing" through X-ray imaging ring 4, pneumatic balloon 6, and warm conduit 5. Combined with the uniform delivery function of ink delivery tube, it comprehensively solves the core problems of in vivo delivery and printing of acoustic ink, and is suitable for clinical scenarios of left atrial appendage occlusion.

[0044] The usage process of the ultrasonic 3D printing occlusion balloon device described in this embodiment is as follows: (1) Preoperative preparation: PNIPAM-PEGDA-agar-based acoustic ink is loaded into ink tank 15, and the insulated catheter 5 is pre-filled with sterile low-temperature saline at 4-10℃ and circulation is started. The temperature is calibrated by temperature monitor 9 to ensure that the temperature inside the ink delivery tube is stable at 25-30℃; the front pneumatic balloon 6 is in a contracted state to reduce tissue trauma during multi-lumen catheter implantation.

[0045] (2) Catheter positioning and pneumatic balloon 6 dilation: The platinum-iridium alloy imaging ring at the front end of the multi-lumen catheter is identified by X-ray imaging, the position of the front end of the multi-lumen catheter is accurately located and synchronized to the ultrasonic 3D printing equipment, and the ultrasonic 3D printing equipment is guided to focus on the front of the multi-lumen catheter; under the dual guidance of X-ray and ultrasound, the front end of the multi-lumen catheter is sent to the target printing area in the body; the inflation and deflation valve 14 is operated to introduce sterile gas into the pneumatic balloon 6, so that the pneumatic balloon 6 expands rapidly and fits tightly against the surrounding tissue, forming a closed local printing chamber without blood flow interference. At the same time, the balloon dilation pressure is monitored by the pressure monitor 13 to avoid excessive pressure that could damage the surrounding tissue.

[0046] (3) Ink delivery and printing: Turn on the ink delivery pump 17, set the appropriate delivery rate through the flow regulating valve 16, and inject the liquid acoustic ink in the heat preservation state into the printing space formed by the pneumatic balloon 6 through the ink delivery pipe 3; start the ultrasonic 3D printing equipment and use the acoustic radiation force to drive the acoustic ink to deposit and form; during the process, the heat preservation conduit 5 continuously introduces the cooling medium to slow down the heating rate of the acoustic ink and ensure that the acoustic ink remains liquid before forming; the pneumatic balloon 6 continuously maintains the expanded state to physically isolate the blood flow from the acoustic ink and avoid material loss and particle entry into the blood.

[0047] (4) Postoperative withdrawal and treatment: After confirming the effect of acoustic ink molding by ultrasound imaging, turn off the ink delivery pump 17, operate the inflation and deflation valve 14 to deflate and contract the pneumatic balloon 6; slowly withdraw the multi-lumen catheter, perform routine hemostasis and disinfection on the printing area, and complete the operation.

[0048] This embodiment features an integrated design that adapts to clinical needs and reduces translation costs. The three core functions are integrated into a multi-lumen catheter, requiring no modification to the existing PNIPAM-PEGDA-agar-based acoustic ink formula. It is compatible with minimally invasive clinical interventional procedures, is easy to operate, requires no additional equipment, reduces R&D and clinical translation costs, and can be directly connected to existing ultrasound 3D printing equipment and left atrial appendage occlusion surgery standards.

[0049] The above content is only for illustrating the technical concept of the present invention and should not be construed as limiting the scope of protection of the present invention. Any modifications made to the technical solution based on the technical concept proposed in this invention shall fall within the scope of protection of this invention.

Claims

1. An occlusion balloon device for use in ultrasonic 3D printing, characterized in that, include: A multi-cavity conduit includes an outer protective sleeve (1) and an inflation conduit (2) and an ink delivery tube (3) located inside the outer protective sleeve (1). The axes of the outer protective sleeve (1), the inflation conduit (2), and the ink delivery tube (3) are parallel. The outer protective sleeve (1) has a first sealing surface and a second sealing surface perpendicular to the axis. The first sealing surface is the front end face of the outer protective sleeve (1), and the second sealing surface is located at one end close to the front end face of the outer protective sleeve (1). A pneumatic balloon (6) is connected to the outer protective sleeve (1) between the first sealing surface and the second sealing surface. The pneumatic balloon (6) communicates with the cavity between the first sealing surface and the second sealing surface. The front end of the inflation conduit (2) communicates with the pneumatic balloon (6), and the front end of the ink delivery tube (3) extends out of the first sealing surface.

2. The occlusion balloon device for ultrasonic 3D printing according to claim 1, characterized in that, The ink delivery tube (3) is covered with an insulated conduit (5), and the distal end of the insulated conduit (5) is connected to an inlet pipe and an outlet pipe.

3. The occlusion balloon device for ultrasonic 3D printing according to claim 2, characterized in that, It also includes a cryogenic medium storage tank (7), which is used to hold sterile saline at 4~10℃; the inlet end of the inlet pipe and the outlet end of the outlet pipe are both connected to the cryogenic medium storage tank (7).

4. The occlusion balloon device for ultrasonic 3D printing according to claim 2, characterized in that, A temperature monitor (9) is installed on the liquid outlet pipeline.

5. The occlusion balloon device for ultrasonic 3D printing according to claim 1, characterized in that, The outer protective sleeve (1) has an X-ray imaging ring (4) at the front end.

6. The occlusion balloon device for ultrasonic 3D printing according to claim 5, characterized in that, The X-ray imaging ring (4) is made of platinum-iridium alloy.

7. The occlusion balloon device for ultrasonic 3D printing according to claim 1, characterized in that, It also includes a gas path switching valve (10), a gas storage tank (11) and a vacuum pump (12); the far end of the gas filling conduit (2) is connected to a gas pipeline, the other end of the gas pipeline is connected to the first port of the gas path switching valve (10), the second port of the gas path switching valve (10) is connected to the gas storage tank (11), and the third port of the gas path switching valve (10) is connected to the vacuum pump (12).

8. The occlusion balloon device for ultrasonic 3D printing according to claim 7, characterized in that, The gas pipeline is equipped with a filling / discharging valve (14).

9. The occlusion balloon device for ultrasonic 3D printing according to claim 7, characterized in that, A pressure monitor (13) is installed on the gas pipeline.

10. The occlusion balloon device for ultrasonic 3D printing according to claim 7, characterized in that, It also includes an ink tank (15), the far end of which is connected to the ink tank (15) via an ink pipeline, and the ink pipeline is equipped with a flow regulating valve (16) and an ink delivery pump (17).

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