A balloon biopsy catheter for pulmonary artery

Abstract

The present invention provides a pulmonary artery balloon biopsy catheter, which belongs to the technical field of balloon biopsy catheters. It comprises a catheter body, one side end of the catheter body is provided with a working channel port, one side end of the catheter body close to the working channel port is provided with an airbag ventilation connection port, a cryoprobe body is installed in the catheter body, and a needle core body is installed in the cryoprobe body. The present invention provides a limit storage mechanism, which not only allows the catheter body to pass through the tortuous path of the pulmonary artery, but also an inflatable airbag body and an inner balloon of the airbag installed at one side end of the catheter body are inflated after reaching the position of the space-occupying lesion, thereby quickly fixing the end of the catheter body, so that the end of the catheter body remains in a stable position during the operation, and the cryoprobe body and the needle core body are used in conjunction with the balloon catheter to perform biopsy after the airbag body and the inner balloon of the airbag are fixed.

Description

Technical Field

[0001] The present invention relates to the technical field of balloon biopsy catheters, in particular to an intrapulmonary artery balloon biopsy catheter. Background Art

[0002] Endocardial biopsy forceps have long been a commonly used biopsy tool in clinical practice, primarily used to sample lesions in the heart's endothelium. However, these traditional tools have significant limitations for lesions within the pulmonary arteries. With the advancement of interventional cardiology and intravascular interventional techniques, there is a growing demand for more accurate and safe pulmonary artery biopsy techniques. Furthermore, intravascular ultrasound (IVUS), a key technology in cardiovascular interventional therapy, uses a catheter to deliver a miniature ultrasound probe into the vascular lumen, displaying cross-sectional images of the vessels and providing in vivo intravascular imaging.

[0003] When using existing endocardial biopsy forceps, since the endocardial biopsy forceps are designed mainly for the endocardium, their rigid or semi-rigid clamp bodies are not suitable for operation in the curved pulmonary artery, making it difficult to reach the target location. In addition, the sampling window of the endocardial biopsy forceps is small, and the sampling volume is limited, which may lead to inaccurate pathological analysis. In addition, the endocardial biopsy forceps cannot be stably fixed in the pulmonary artery during sampling, which may lead to inaccurate sampling or damage to the blood vessel wall. Percutaneous lung biopsy needles also have some disadvantages when in use. First, they are difficult to operate and require precise positioning, which requires high technical skills from the doctor. In addition, their sampling volume is limited, and it may be difficult to accurately control the sampling position due to the linear movement of the needle tip. Moreover, since the sampling direction is difficult to control, the risk of vascular perforation and bleeding may increase. Therefore, the present application provides a pulmonary artery balloon biopsy catheter to meet the needs. Summary of the Invention

[0004] The technical problem to be solved by the present invention is to provide an intrapulmonary artery balloon biopsy catheter. By setting a limiting storage mechanism, not only can the catheter body pass through the tortuous path of the pulmonary artery, but an inflatable balloon body and an inner balloon installed at the end of one side of the catheter body are inflated after reaching the position of the space-occupying lesion, thereby quickly fixing the end of the catheter body, so that the end of the catheter body can maintain a stable position during the operation. The space for temporary storage of samples formed by the inflation of the balloon body and the inner balloon of the balloon is utilized to temporarily store the samples obtained by the needle core body. The above settings can solve the problems of limited sampling volume and poor sampling stability.

[0005] In order to solve the above technical problems, the present invention provides the following technical solutions:

[0006] A balloon biopsy catheter in the pulmonary artery includes a catheter body. One end of the catheter body is provided with a working channel opening. One end of the catheter body near the working channel opening is provided with a balloon ventilation connection port. A cryoprobe body is installed inside the catheter body, and a needle core body is installed inside the cryoprobe body; a limiting storage mechanism for limiting the end of the catheter body far from the working channel opening and temporarily storing the sample obtained at the end of the needle core body, and the limiting storage mechanism is connected to the catheter body.

[0007] Optionally, the limiting storage mechanism includes a catheter end installed on the catheter body. An airbag body is fixedly connected to the outer wall of the catheter end. Three airbag inner sacs are annularly and equidistantly arranged inside the airbag body. Three limiting skeletons are annularly and equidistantly installed on the outer wall of the catheter end. A first end piece is fixedly connected to the top of the airbag body, and a second end piece is fixedly connected to the bottom of the airbag body.

[0008] Optionally, the limiting skeletons and the airbag inner sacs are staggeredly distributed on the outer wall of the catheter end, and the airbag body, the first end piece and the second end piece are integrally formed.

[0009] Optionally, the airbag body and the airbag inner sacs are integrally formed. The cavities inside the airbag body and the airbag inner sacs are connected. One side of the airbag inner sac close to the catheter end is fixedly connected to the outer wall of the catheter end. The two end heads on the top and bottom sides of the airbag body are respectively fixedly connected to the two end heads of the catheter end.

[0010] Optionally, a first groove is opened on one side of the catheter body far from the working channel opening. Three first groove bodies are annularly and equidistantly opened on the catheter end. A second groove is provided in the middle of the catheter end. Five second groove bodies are annularly and equidistantly opened on the second end piece.

[0011] Optionally, a limiting piece is installed on the catheter body in the direction close to the first groove. A limiting ring is fixedly connected to the bottom of the limiting piece. The inner diameter of the limiting ring is equal to the outer diameter of the catheter end.

[0012] Optionally, second lightening grooves are annularly and equidistantly opened on the limiting piece. The limiting piece and the limiting ring are integrally formed. The limiting piece is made of plastic material.

[0013] Optionally, the outer wall of the limiting piece is wrapped with a transparent rubber film, and the outer wall edges of the limiting piece and the limiting ring are both arc-shaped.

[0014] Optionally, a third slot is provided on the limiting frame, the third slot is narrow at the top and wide at the bottom, the limiting frame is fixedly connected with a guide plate close to the third slot, and the guide plate is equidistantly provided with a first lightweight slot.

[0015] Optionally, a first weakening groove is provided on the top of the limiting piece, a second weakening groove is provided on the top of the limiting piece, and a third weakening groove is provided on the top of the limiting frame.

[0016] Compared with the prior art, the present invention has at least the following beneficial effects:

[0017] In the above scheme, by setting a limit storage mechanism, not only can the catheter body pass through the tortuous path of the pulmonary artery, but also an inflatable balloon body and an inner balloon installed at the end of one side of the catheter body are inflated after reaching the position of the space-occupying lesion, so that the end of the catheter body can be quickly fixed, so that the end of the catheter body can maintain a stable position during the operation, and the freezing probe body and the needle core body are used in conjunction with the balloon catheter to perform biopsy after the balloon body and the inner balloon are fixed. The needle core body can take samples while freezing tissue, reducing the risk of bleeding and improving the quality of the samples. After the samples are taken using the freezing probe body and the needle core body, the temporary sample space formed by the inflation of the airbag body and the inner balloon of the airbag is used to temporarily store the samples taken by the needle core body. The freezing probe body and the needle core body are repeatedly operated to take samples, and multiple samples can be taken at one time. Finally, multiple samples are taken out and tested together with the catheter body and the airbag body. The coordinated use of the structures enables the device to achieve sufficient space-occupying and multiple sampling in the pulmonary blood vessels. The device combines the medical device field of intravascular ultrasound technology, intracavitary imaging technology and frozen biopsy technology. It can establish a tunnel in the pulmonary artery space-occupying lesion. The device can also be used in conjunction with an intravascular ultrasound probe and a protective brush for accurate diagnosis of space-occupying lesions in the pulmonary artery and real-time tissue evaluation.

[0018] By arranging an airbag body and an inner airbag bag in the position limiting storage mechanism, since the airbag body, the inner airbag bag and the catheter body are made of a flexible rubber material, it is ensured that they can pass smoothly through the tortuosity of the blood vessel, and the airbag body and the inner airbag bag have sufficient strength, thereby ensuring that they can expand evenly after inflation to adapt to different blood vessel diameters. The expanded airbag body and the inner airbag bag after inflation can well limit the end of the catheter body, so that the end of the catheter body close to the sampling point has better stability during the biopsy operation. The coordinated use of the structures effectively makes the use effect of the position limiting storage mechanism better, and the structure is simple and easy to use.

[0019] By providing a limiting framework and guiding pieces inside the limiting storage mechanism, after the catheter body is placed in the desired position and the balloon body and the balloon inner sac are inflated, the limiting framework expands as the balloon inner sac expands. Then, the cryoprobe body and the needle core body inside the catheter body are operated to perform a sampling operation at the end of the needle core body. After one sampling is completed, the obtained sample is temporarily stored between the cavity formed by the limiting framework, the balloon inner sacs on both sides of it, and the outer wall of the catheter end. There are three such temporary storage cavities in total. After repeatedly operating the cryoprobe body and the needle core body to perform three samplings, the end of the needle core body passes through the third groove body and moves along the guidance of the guiding piece towards the wider side of the limiting framework away from the third groove body. When the needle core body reaches the end of the narrower side of the third groove body, the guiding pieces on both sides of the needle core body slightly squeeze the needle core body. Then, the needle core body is pulled, and the sample obtained at the end of the needle core body is scraped off from its end, so that the sample is temporarily stored between the cavity formed by the inner wall of the limiting framework and the outer walls of the balloon inner sacs on both sides. The third groove body is in a non-through shape on the limiting framework, so that a temporarily storage cavity with three-sided closure can be formed between the limiting framework, the side of the balloon inner sac away from the third groove body, and the outer wall of the catheter end. The guiding piece is fixedly connected to the limiting framework in the direction close to the third groove body, and the guiding piece is an arc-shaped structure recessed towards the center position of the catheter end. The cooperation of the third groove body and the guiding piece further enables the sample to be quickly placed in the temporarily storage space formed by the inner wall of the limiting framework and the outer wall of the balloon inner sac. The first lightweight grooves are equidistantly arranged on the guiding piece, which enhances the deformability of the guiding piece and at the same time reduces the mass of the guiding piece. Then, the air in the balloon body and the balloon inner sac is released, and the balloon inner sac and the limiting framework move closer to the catheter end, so that the obtained sample is stably placed between the balloon inner sac and the limiting framework. The device can obtain multiple samples at one time during sampling, and then by using the detection of multiple samples, the accuracy of sample detection is further ensured. The cooperation between the structures effectively makes the use effect of the limiting storage mechanism better, and the structure is simple and convenient to use.

[0020] By providing a limiting piece and a limiting ring inside the limiting storage mechanism, when the airbag body and the inner airbag expand, the limiting ring slides along the outer wall of the airbag body towards the limiting piece along the outer wall of the first end piece. Affected by the extrusion force, the limiting piece completely forms an arc structure. After separating from the airbag body, the inner airbag and the airbag body can be fully unfolded. Moreover, the limiting framework inside the airbag body is unfolded together with the inner airbag for use. The bent limiting piece contacts and presses against the inner wall of the blood vessel, enabling the bent arc-shaped limiting piece to cooperate with the airbag body and the inner airbag to more stably limit the end of the catheter body at a specific working position. After use, the airbag body and the inner airbag are retracted on the outer wall of the catheter head. The limiting piece rebounds, causing the limiting ring to be sleeved on the airbag body to limit the airbag body, the inner airbag, and the limiting framework, so that the airbag body, the inner airbag, and the limiting framework are more stably retracted on the catheter head, facilitating the movement of the side end of the catheter body near the catheter head in the tortuous blood vessel. The combined use of the structures effectively improves the use effect of the limiting storage mechanism, and the structure is simple and convenient to use.

[0021] By providing a first groove body and a second groove body inside the limiting storage mechanism, not only can the combined use of the first groove body and the second groove body be utilized, but the end of the needle core body passing through different first groove bodies and second groove bodies can obtain different sampling angles. Furthermore, the needle core body can be sampled more flexibly according to the specific on-site use conditions. The combined use of the structures effectively improves the use effect of the limiting storage mechanism, and the structure is simple and convenient to use.

[0022] In summary, this device can not only anchor the biopsy tool at the location of the space-occupying lesion in the pulmonary artery more accurately through the combined use of the limiting storage mechanism and its various components, and cooperate with the catheter body with the existing intravascular ultrasound technology and intravascular imaging technology to establish a sampling tunnel and improve the accuracy of sampling. By cooperating with the use of a 1.1.mm cryoprobe body, sampling can be performed while freezing the tissue, reducing tissue elasticity and movement, and further improving the quality and accuracy of the biopsy sample. And multiple samplings are performed after the tunnel is established to obtain a more sufficient tissue sample to meet the needs of pathological analysis. During the sampling process, the airbag body and the inner airbag fix the end of the catheter body, effectively reducing the movement of the catheter in the blood vessel and reducing the risks of vascular injury and postoperative complications. The use of the cryoprobe in the catheter tunnel reduces the bleeding risk. Moreover, the structure of this device is simple, convenient and fast to use, the production cost of the device is low, and the practicability is good, facilitating promotion and use. Brief Description of the Drawings

[0023] The accompanying drawings incorporated herein and constituting a part of the specification illustrate embodiments of the present invention and, together with the specification, are further used to explain the principles of the present invention and enable those skilled in the relevant art to implement and use the present invention.

[0024] Figure 1 It is a schematic three-dimensional structure diagram of a balloon biopsy catheter in the pulmonary artery;

[0025] Figure 2 It is a schematic enlarged structure diagram of the catheter end;

[0026] Figure 3 It is a schematic three-dimensional enlarged sectional structure diagram of the balloon body;

[0027] Figure 4 It is Figure 3 a schematic enlarged structure diagram of the place A in

[0028] Figure 5 It is a schematic three-dimensional enlarged structure diagram of the cooperation between the balloon body and the limiting piece;

[0029] Figure 6 It is a schematic three-dimensional enlarged structure diagram of the cooperation between the limiting piece and the limiting framework from the first perspective;

[0030] Figure 7 It is Figure 6 a schematic enlarged structure diagram of the place B in

[0031] Figure 8 It is Figure 6 a schematic enlarged structure diagram of the place C in

[0032] Figure 9 It is a schematic three-dimensional enlarged structure diagram of the cooperation between the limiting piece and the limiting framework from the second perspective;

[0033] Figure 10 It is a schematic three-dimensional enlarged sectional structure diagram of the cooperation between the balloon body and the inner balloon of the balloon.

[0034] Reference numerals:

[0035] 1. Catheter body; 2. Working channel opening; 3. Balloon ventilation connection port; 4. Cryoprobe body; 5. Core body; 6. First groove; 7. Catheter end; 8. First groove body; 9. Second groove; 10. Balloon body; 11. Inner balloon of the balloon; 12. Limiting framework; 13. First end piece; 14. Second end piece; 15. Second groove body; 16. Third groove body; 17. Guide piece; 18. First lightweight groove; 19. Limiting ring; 20. Limiting piece; 21. Second lightweight groove; 22. First weakening groove; 23. Second weakening groove; 24. Third weakening groove.

[0036] As shown in the figure, in order to clearly implement the structure of the embodiments of the present invention, specific structures and devices are marked in the figure. However, this is only for illustrative purposes and is not intended to limit the present invention to this specific structure, device, and environment. Those of ordinary skill in the art can adjust or modify these devices and environments according to specific needs. Detailed implementation manners

[0037] The following will describe in detail a balloon biopsy catheter in the pulmonary artery provided by the present invention with reference to the accompanying drawings and specific embodiments. At the same time, it should be noted here that in order to make the embodiments more detailed, the following embodiments are the best and preferred embodiments. For some well-known technologies, those skilled in the art can also adopt other alternative methods for implementation; moreover, the accompanying drawings are only for more specifically describing the embodiments and are not intended to specifically limit the present invention.

[0038] It should be pointed out that in the specification, the mention of "one embodiment", "embodiment", "exemplary embodiment", "some embodiments", etc. indicates that the described embodiment may include specific features, structures or characteristics, but not necessarily every embodiment includes such specific features, structures or characteristics. Additionally, when combining embodiments to describe specific features, structures or characteristics, it should be within the knowledge of those skilled in the relevant art whether other embodiments are explicitly described to achieve such features, structures or characteristics.

[0039] Generally, terms can be understood at least in part from their use in context. For example, at least in part depending on the context, the term "one or more" used herein can be used to describe any feature, structure or characteristic in a singular sense, or can be used to describe a combination of features, structures or characteristics in a plural sense. Additionally, the term "based on" can be understood as not necessarily intended to convey a set of exclusive factors, but instead, at least in part depending on the context, allowing for the existence of other factors that may not be explicitly described.

[0040] It can be understood that the meanings of "on...", "above...", and "overhead of..." in the present invention should be interpreted in the broadest manner, so that "on..." not only means "directly on" something, but also includes the meaning of being "on" something with intermediate features or layers therebetween, and "above..." or "overhead of..." not only means "above" or "overhead of" something, but also can include the meaning of being "above" or "overhead of" something with no intermediate features or layers therebetween.

[0041] Additionally, spatially relative terms such as "below," "beneath," "lower," "above," and "upper" may be used herein for descriptive convenience to describe the relationship of one element or feature to another element or features, as illustrated in the accompanying drawings. Spatially relative terms are intended to encompass different orientations of the device in use or operation in addition to the orientation depicted in the accompanying drawings. The device may be oriented in other ways, and the spatially relative descriptors used herein should be similarly interpreted accordingly.

[0042] like Figure 1 and Figure 2 As shown, an embodiment of the present invention provides a pulmonary artery balloon biopsy catheter, comprising a catheter body 1, one side end of the catheter body 1 is provided with a working channel port 2, the side end of the catheter body 1 close to the working channel port 2 is provided with an airbag ventilation connection port 3, a cryoprobe body 4 is installed in the catheter body 1, and a needle core body 5 is installed in the cryoprobe body 4; a position limiting storage mechanism, the position limiting storage mechanism is used to limit the side end of the catheter body 1 away from the working channel port 2 and temporarily store the sample obtained from the end of the needle core body 5, the position limiting storage mechanism is connected to the catheter body 1, the position limiting storage mechanism includes a catheter tip 7 installed on the catheter body 1, the catheter tip 7 is installed on the catheter body 1, and the catheter tip 7 is installed on the catheter body 1. The outer wall of 7 is fixedly connected to the airbag body 10, and three airbag inner balloons 11 are equidistantly arranged in a ring inside the airbag body 10. The cryoprobe body 4 is a 1.1mm cryoprobe. The catheter body 1 can pass through the tortuous path of the pulmonary artery through the limit storage mechanism. Then, an inflatable airbag body 10 and an airbag inner balloon 11 installed at the end of one side of the catheter body 1 reach the position of the space-occupying lesion and are inflated, so that the end of the catheter body 1 can be quickly fixed, so that the end of the catheter body 1 can maintain a stable position during the operation, and the cryoprobe body 4 and the needle core body 5 are used in conjunction with the balloon catheter, and biopsy is performed after the airbag body 10 and the airbag inner balloon 11 are fixed.

[0043] The needle core body 5 can obtain samples while freezing tissues, reducing the risk of bleeding and improving the quality of sample acquisition. After the freezing probe body 4 and the needle core body 5 are used to obtain samples, the components in the limit storage mechanism form a space for temporarily storing samples due to the inflation and expansion of the airbag body 10 and the inner airbag 11, and the samples obtained by the needle core body 5 are temporarily stored. The freezing probe body 4 and the needle core body 5 can be operated repeatedly for sampling, enabling multiple samplings at one time. Finally, multiple samples are taken out and detected together with the catheter body 1 and the airbag body 10. The coordinated use of the structures enables the device to achieve sufficient and multiple samplings of intrapulmonary vascular space-occupying lesions. When used in conjunction with an intravascular ultrasound probe, morphological evaluation of the space-occupying lesion is performed before and after biopsy through ultrasound imaging technology, providing a more accurate description of the lesion. At the same time, a protective brush is used in combination with the bedside ROSE technology to perform rapid and real-time diagnosis of intrapulmonary vascular space-occupying lesions. The above-mentioned ultrasound probe, protective brush, freezing probe body 4, and needle core body 5 are all existing mature technologies, so their working principles and specific structures will not be elaborated here. The specific working principle of the above-mentioned limit storage mechanism is described in detail below.

[0044] Among them, the airbag body 10 and the inner airbag 11 are made of rubber materials with good flexibility to ensure smooth passage through the tortuous blood vessels. The airbag body 10 and the inner airbag 11 have sufficient strength to ensure uniform expansion after inflation to adapt to different blood vessel diameters. The above-mentioned freezing probe body 4 and needle core body 5 are comprehensively disinfected and cleaned before use to ensure hygiene and reduce the risk of cross-infection.

[0045] As Figures 2 to 10 shown, the limit storage mechanism includes a catheter end 7 installed on the catheter body 1. The catheter body 1 and the catheter end 7 are integrally formed. The outer wall of the catheter end 7 is fixedly connected to an airbag body 10. Three inner airbags 11 are annularly and equidistantly arranged inside the airbag body 10. The airbag body 10 and the inner airbag 11 are integrally formed. The cavities inside the airbag body 10 and the inner airbag 11 are connected as Figure 10 shown. The side of the inner airbag 11 close to the catheter end 7 is fixedly connected to the outer wall of the catheter end 7. The top and bottom sides of the airbag body 10 are fixedly connected to the two sides of the catheter end 7 respectively. Three limit skeletons 12 are annularly and equidistantly installed on the outer wall of the catheter end 7. One side end of the limit skeleton 12 is fixedly connected to the outer wall of the catheter end 7. The two outer walls of the limit skeleton 12 are fixedly connected to the side walls of the inner airbag 11. The limit skeleton 12 and the inner airbag 11 are staggeredly distributed on the outer wall of the catheter end 7 as Figure 10 shown.

[0046] After placing the catheter body 1 in the desired position and inflating the balloon body 10 and the balloon inner sac 11, the limiting framework 12 expands along with the inflation of the balloon inner sac 11. Then, operate the cryoprobe body 4 and the stylet body 5 inside the catheter body 1 to perform a sampling operation at the end of the stylet body 5. After one sampling is completed, place the obtained sample temporarily between the cavity formed by the limiting framework 12, the balloon inner sac 11 on both sides of it, and the outer wall of the catheter tip 7 as Figure 4 and Figure 10 shown. There are a total of three such temporary storage cavities. After repeatedly operating the cryoprobe body 4 and the stylet body 5 to perform three samplings, deflate the balloon body 10 and the balloon inner sac 11. The balloon inner sac 11 and the limiting framework 12 move closer to the catheter tip 7. At this time, the taken samples are stably placed between the balloon inner sac 11 and the limiting framework 12. Then, take out the catheter body 1, inflate the balloon body 10 and the balloon inner sac 11 again, and use tweezers to take out the multiple samples temporarily stored between the balloon inner sac 11 and the limiting framework 12 for detection. By using the cooperation between the structures, this device can not only quickly limit the position during sampling, making the device have better stability during sampling, but also obtain multiple samples at one time. Then, through the detection of multiple samples, the accuracy of sample detection is further ensured. Moreover, the structure of the device is simple, it is more convenient and fast to use, and the practicability of the device is good, which is convenient for popularization and use.

[0047] Among them, a first end piece 13 is fixedly connected to the top of the balloon body 10, and a second end piece 14 is fixedly connected to the bottom of the balloon body 10. The balloon body 10, the first end piece 13, and the second end piece 14 are integrally formed. The integrated structure formed by the balloon body 10, the first end piece 13, and the second end piece 14 has an elliptical cross-section in the inflated state of the balloon body 10 and the balloon inner sac 11, so that the overall shape of the device is more smooth during use. Three first grooves 8 are annularly and equally spaced on the catheter tip 7, and five second grooves 15 are annularly and equally spaced on the second end piece 14. By using the cooperation of the first grooves 8 and the second grooves 15, the end of the stylet body 5 passing through different first grooves 8 and second grooves 15 can obtain different sampling angles, so that the stylet body 5 can sample more flexibly according to the specific on-site use situation. And through the cooperation between the structures, the use effect of the limiting storage mechanism is further improved, and the structure is simple, and it is more convenient and fast to use.

[0048] As Figures 3 to 10 shown, a limiting piece 20 is installed on the catheter body 1 close to the direction of the first groove 6. A limiting ring 19 is fixedly connected to the bottom of the limiting piece 20. The inner diameter of the limiting ring 19 is equal to the outer diameter of the catheter tip 7. When the balloon body 10 and the balloon inner sac 11 are inflated, the limiting piece 20 is bent and located at the top of the balloon body 10, and the limiting ring 19 is located at the tip of the top of the balloon body 10 asFigure 3 As shown. In the non-inflated state of the airbag body 10 and the inner airbag 11, the inner airbag 11 and the limiting framework 12 are folded on the outer wall of the catheter end 7. The limiting piece 20 approaches a straight line, and the limiting ring 19 is sleeved on the outer wall of the airbag body 10. This is the natural state of the limiting piece 20 and the limiting ring 19 without external force.

[0049] Therefore, during use, by utilizing the inflation of the airbag body 10 and the inner airbag 11, the limiting ring 19 can slide from the outer wall of the airbag body 10 along the outer wall of the first end piece 13 towards the limiting piece 20. Affected by the extrusion force, the limiting piece 20 completely forms an arc structure, so that the inner airbag 11 and the airbag body 10 can be fully unfolded, and the limiting framework 12 is unfolded and used together. Moreover, the bent limiting piece 20 contacts and presses against the inner wall of the blood vessel. The use of the limiting piece 20 bent into an arc structure in cooperation with the airbag body 10 and the inner airbag 11 can make the end of the catheter body 1 more stably limited in a specific working position.

[0050] After use, the airbag body 10 and the inner airbag 11 are folded on the outer wall of the catheter end 7. The limiting piece 20 rebounds, causing the limiting ring 19 to be sleeved on the airbag body 10 to limit the airbag body 10, the inner airbag 11 and the limiting framework 12, so that the airbag body 10, the inner airbag 11 and the limiting framework 12 are more stably folded on the catheter end 7. And in the initial state, that is, in the non-inflated state of the airbag body 10 and the inner airbag 11, the limiting framework 12 approaches a straight line, making it more convenient for the limiting piece 20 to be sleeved on the airbag body 10 in the natural state, thus facilitating the movement of the end of the catheter body 1 on the side close to the catheter end 7 in a tortuous blood vessel. Through the cooperative use of the structures, the use effect of the limiting storage mechanism is further improved, and the structure is simple and convenient to use.

[0051] Among them, a second groove 9 is provided in the middle of the catheter end 7, and a first groove 6 is formed on one side of the catheter body 1 away from the working channel opening 2, which can enable the airbag body 10 and the airbag inner bladder 11 to be retracted therein when not in use, and enable the limiting piece 20 to be retracted therein when not in use, so that the outer wall of the catheter body 1 is overall smoother, facilitating the use and operation of the catheter body 1. The limiting piece 20 is annularly and equidistantly provided with second lightening grooves 21, which makes the deformation ability of the limiting piece 20 better and at the same time makes the mass of the limiting piece 20 lighter. The limiting piece 20 and the limiting ring 19 are integrally formed, and the connection stability of the integral structure is better. The limiting piece 20 is made of plastic material, and the cost of the plastic material is lower, and the plastic material itself has good deformation ability. The outer wall of the limiting piece 20 is wrapped with a transparent rubber film. The outer wall edges of the limiting piece 20 and the limiting ring 19 are both arc-shaped, so that the limiting piece 20 does not contact the inner wall of the blood vessel. The relatively smooth and soft rubber film is used to contact the blood vessel, preventing the limiting piece 20 from scratching the inner wall of the blood vessel when squeezing the blood vessel, and the arc shape has no obvious edges and corners, further preventing the problem that the limiting piece 20 scratches the inner wall of the blood vessel when contacting the inner wall of the blood vessel.

[0052] The top of the limiting piece 20 is provided with a first weakening groove 22, and the top of the limiting piece 20 is provided with a second weakening groove 23. The setting of the first weakening groove 22 and the second weakening groove 23 makes it easier for the limiting piece 20 to bend and deform from these two points when subjected to external force, thereby further enhancing the deformation ability of the limiting piece 20. The top of the limiting frame 12 is provided with a third weakening groove 24, so that the limiting frame 12 can first deform from the third weakening groove 24 when subjected to external force, so that the airbag inner bag 11 can drive the limiting frame 12 to unfold faster when it expands. A third groove body 16 is provided on the limiting frame 12, and the third groove body 16 is narrow at the top and wide at the bottom. The third groove body 16 is a non-through limiting frame 12 shape on the limiting frame 12, so that the limiting frame 12 and the side of the airbag inner bag 11 away from the third groove body 16 and the outer wall of the catheter end 7 can form a temporary storage cavity closed on three sides, and the third groove body 16 The design is convenient for limiting and guiding the end of the needle core body 5, and its narrow top and wide bottom shape further enhances the guiding effect of the third groove body 16 on the end of the needle core body 5, so that the sample obtained at the end of the needle core body 5 is quickly placed in the temporary storage space formed by the inner wall of the limiting skeleton 12 and the outer wall of the inner bag 11 of the airbag. The limiting skeleton 12 is fixedly connected with a guide piece 17 near the direction of the third groove body 16. The guide piece 17 is an arc-shaped structure recessed toward the center position of the catheter end 7. The third groove body 16 cooperates with the use of the guide piece 17 to further enable the sample to be quickly placed in the temporary storage space formed by the inner wall of the limiting skeleton 12 and the outer wall of the inner bag 11 of the airbag. The first lightweight grooves 18 are equidistantly provided on the guide piece 17, which enhances the deformability of the guide piece 17 and reduces the weight of the guide piece 17. The device further makes the use effect of the limiting storage mechanism better through the coordinated use of the structures, and has a simple structure and is relatively convenient and quick to use.

[0053] The workflow of the technical solution provided by the present invention is as follows:

[0054] First, the limiting ring 19 is sleeved on the airbag body 10, so that the limiting plate 20 is close to a straight line and retracted in the first groove 6, so that the airbag body 10 and the airbag inner balloon 11 as well as the limiting frame 12 and the various components therein are retracted in the second groove 9. At this time, the entire outer wall structure of the device is relatively smooth; then the catheter body 1 is passed through the tortuous path of the pulmonary artery, and then an inflatable airbag body 10 and the airbag inner balloon 11 installed at the end of one side of the catheter body 1 reach the position of the space-occupying lesion and are inflated to quickly fix the end of the catheter body 1, so that the end of the catheter body 1 remains in a stable position during the operation, and the limiting frame 12 is expanded as the airbag inner balloon 11 expands and then the freezing probe body 4 and the needle core body 5 are used in conjunction with the balloon catheter, and a biopsy is performed after the airbag body 10 and the airbag inner balloon 11 are fixed.

[0055] During the biopsy sampling process, the end of the needle core body 5 performs a sampling operation. After one sampling is completed, the end of the needle core body 5 passes through the third groove body 16 and moves along the guidance of the guiding piece 17 towards the wider side of the limiting framework 12 away from the third groove body 16. When the needle core body 5 reaches the end of the narrower side of the third groove body 16, the guiding pieces 17 on both sides of the needle core body 5 slightly squeeze the needle core body 5. Then, the needle core body 5 is pulled, and the sample obtained at the end of the needle core body 5 is scraped off from its end and temporarily stored between the inner wall of the limiting framework 12 and the outer wall of the inner air sac 11 on both sides thereof as Figure 4 and Figure 10 shown. There are a total of three cavities formed between the inner wall of the limiting framework 12 and the outer wall of the inner air sac 11 on both sides thereof. After the medical staff repeatedly operate the cryoprobe body 4 and the needle core body 5 to perform three samplings and place the samples in the three temporarily stored cavities respectively, the air in the air sac body 10 and the inner air sac 11 is released. The inner air sac 11 and the limiting framework 12 move closer to the catheter end 7. At this time, the taken samples are stably placed between the inner air sac 11 and the limiting framework 12. Then, the catheter body 1 is taken out, the air sac body 10 and the inner air sac 11 are inflated again, and the multiple samples temporarily stored between the inner air sac 11 and the limiting framework 12 are taken out by using tweezers for detection. By using the cooperation between the structures, this device can not only quickly limit the position during sampling, making the device have better stability during sampling, but also obtain multiple samples at one time. Then, by using the detection of multiple samples, the accuracy of sample detection is further ensured.

[0056] Moreover, during the process of sampling at the end of the needle core body 5, by using the cooperation of the first groove body 8 and the second groove body 15, different sampling angles can be obtained when the end of the needle core body 5 passes through different first groove bodies 8 and second groove bodies 15. Furthermore, the needle core body 5 can sample more flexibly according to the specific on-site usage situation. And when the air sac body 10 and the inner air sac 11 are inflated and expanded, the limiting piece 20 is bent and located at the top of the air sac body 10, and the limiting ring 19 is located at the end of the top of the air sac body 10 as Figure 3 shown.

[0057] When the airbag body 10 and the inner airbag 11 are in a non-inflated state, the inner airbag 11 and the limiting framework 12 are folded on the outer wall of the catheter tip 7. The limiting piece 20 is close to a straight line, and the limiting ring 19 is sleeved on the outer wall of the airbag body 10. During use, by utilizing the inflation of the airbag body 10 and the inner airbag 11, the limiting ring 19 can slide from the outer wall of the airbag body 10 along the outer wall of the first end piece 13 towards the limiting piece 20. Affected by the extrusion force, the limiting piece 20 completely forms an arc structure, so that the inner airbag 11 and the airbag body 10 can be fully deployed, and the limiting framework 12 is deployed for use together. Moreover, the bent limiting piece 20 contacts and presses against the inner wall of the blood vessel, and the limiting piece 20 bent into an arc structure can cooperate with the airbag body 10 and the inner airbag 11 to more stably limit the end of the catheter body 1 at a specific working position. After use, the airbag body 10 and the inner airbag 11 are folded on the outer wall of the catheter tip 7, and the limiting piece 20 rebounds, causing the limiting ring 19 to be sleeved on the airbag body 10 to limit the airbag body 10, the inner airbag 11 and the limiting framework 12, so that the airbag body 10, the inner airbag 11 and the limiting framework 12 are more stably folded on the catheter tip 7, facilitating the movement of the end of the catheter body 1 near the catheter tip 7 in the tortuous blood vessel.

[0058] Among them, the second lightweight grooves 21 are annularly and equidistantly arranged on the limiting piece 20, making the deformation ability of the limiting piece 20 better and the mass of the limiting piece 20 lighter at the same time. The limiting piece 20 and the limiting ring 19 are integrally formed, and the connection stability of the integral structure is better. The limiting piece 20 is made of plastic material, and the cost of the plastic material is lower. Moreover, the plastic material itself has good deformation ability. The outer wall of the limiting piece 20 is wrapped with a transparent rubber film. The outer wall edges of the limiting piece 20 and the limiting ring 19 are both arc-shaped, so that the limiting piece 20 does not contact the inner wall of the blood vessel, and the relatively smooth and soft rubber film is used to contact the blood vessel to prevent the limiting piece 20 from scratching the inner wall of the blood vessel when squeezing the blood vessel. Moreover, the arc shape has no obvious edges and corners, further preventing the problem that the limiting piece 20 scratches the inner wall of the blood vessel when contacting the inner wall of the blood vessel. The first weakened groove 22 is opened at the top of the limiting piece 20, and the second weakened groove 23 is opened at the top of the limiting piece 20. The arrangement of the first weakened groove 22 and the second weakened groove 23 makes the limiting piece 20 more likely to bend and deform from these two points under the action of external force, further enhancing the deformation ability of the limiting piece 20. The third weakened groove 24 is opened at the top of the limiting framework 12, so that the limiting framework 12 can deform first from the third weakened groove 24 under the action of external force, so that the limiting framework 12 can be more quickly driven to deploy when the inner airbag 11 expands.

[0059] The limiting framework 12 is provided with a third groove 16. The third groove 16 is narrow at the top and wide at the bottom. The design of the third groove 16 facilitates the limiting and guiding of the end of the needle core body 5. Moreover, its shape of being narrow at the top and wide at the bottom further enhances the guiding effect of the third groove 16 on the end of the needle core body 5, so that the sample obtained at the end of the needle core body 5 can be quickly placed in the temporary storage space formed by the inner wall of the limiting framework 12 and the outer wall of the inner bladder 11 of the airbag. The limiting framework 12 is fixedly connected with a guiding piece 17 in the direction close to the third groove 16. The guiding piece 17 is an arc-shaped structure sunken towards the center position of the catheter end 7. The cooperation of the third groove 16 and the guiding piece 17 further enables the sample to be quickly placed in the temporary storage space formed by the inner wall of the limiting framework 12 and the outer wall of the inner bladder 11 of the airbag. Equally spaced first lightweight grooves 18 are formed in the guiding piece 17, which enhances the deformability of the guiding piece 17 and at the same time reduces the mass of the guiding piece 17. Through the cooperative use of the structures, the use effect of the limiting storage mechanism of the present device is further improved, and the structure is simple, convenient and fast to use, and the practicability of the device is good.

[0060] The present invention covers any substitutions, modifications, equivalent methods and solutions made on the essence and scope of the present invention. In order to enable the public to have a thorough understanding of the present invention, specific details are described in detail in the following preferred embodiments of the present invention. However, those skilled in the art can also fully understand the present invention without the description of these details. In addition, well-known methods, processes, procedures, components and circuits are not described in detail to avoid unnecessary confusion to the essence of the present invention.

[0061] The above are only the preferred embodiments of the present invention. It should be noted that for those of ordinary skill in the art, without departing from the principle of the present invention, several improvements and refinements can be made, and these improvements and refinements should also be regarded as the protection scope of the present invention.

Claims

1. A pulmonary artery balloon biopsy catheter, characterized in that: The catheter body comprises a catheter body, one end of which is provided with a working channel opening, an end of which is close to the working channel opening and an airbag ventilation connection port, a cryoprobe body installed in the catheter body, and a needle core body installed in the cryoprobe body; A position limiting storage mechanism, the position limiting storage mechanism is used to limit the end portion of the catheter body away from the working channel opening and temporarily store the sample obtained by the end of the needle core body, and the position limiting storage mechanism is connected to the catheter body; The position limiting storage mechanism includes a catheter tip mounted on a catheter body, an outer wall of the catheter tip is fixedly connected to an airbag body, three airbag inner bags are equidistantly arranged in an annular manner in the airbag body, three position limiting frames are equidistantly arranged in an annular manner on the outer wall of the catheter tip, a first end piece is fixedly connected to the top of the airbag body, and a second end piece is fixedly connected to the bottom of the airbag body; The limiting frame and the inner balloon are staggeredly distributed on the outer wall of the catheter tip, and the balloon body, the first end piece and the second end piece are integrally formed; The airbag body and the airbag inner bag are integrally formed, the cavities of the airbag body and the airbag inner bag are connected, the side of the airbag inner bag close to the catheter end is fixedly connected to the outer wall of the catheter end, and the top and bottom ends of the airbag body are fixedly connected to the two side ends of the catheter end respectively; A first groove is formed on a side of the catheter body away from the working channel opening, three first grooves are formed in an annular pattern at equal intervals on the catheter tip, a second groove is formed in the middle of the catheter tip, and five second grooves are formed in an annular pattern at equal intervals on the second end piece; A limiting plate is installed on the catheter body close to the first groove, and the bottom of the limiting plate is fixedly connected to a limiting ring, and the inner diameter of the limiting ring is equal to the outer diameter of the catheter end.

2. The pulmonary artery balloon biopsy catheter according to claim 1, characterized in that: The limiting plate is provided with second lightweight grooves at equal intervals in a ring shape. The limiting plate and the limiting ring are integrally formed, and the limiting plate is made of plastic material.

3. The pulmonary artery balloon biopsy catheter according to claim 1, characterized in that: The outer wall of the limiting piece is wrapped with a transparent rubber film, and the outer wall edges of the limiting piece and the limiting ring are both arc-shaped.

4. The pulmonary artery balloon biopsy catheter according to claim 1, characterized in that: A third slot is provided on the limiting frame, and the third slot is narrow at the top and wide at the bottom. A guide piece is fixedly connected to the limiting frame near the third slot, and the first lightweight slots are equidistantly provided on the guide piece.

5. The pulmonary artery balloon biopsy catheter according to claim 1, characterized in that: A first weakening groove is formed on the top of the limiting piece, a second weakening groove is formed on the top of the limiting piece, and a third weakening groove is formed on the top of the limiting frame.

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