Balloon dilatation catheter
By designing a balloon dilation catheter with both a dilation balloon and a diagnostic balloon, the problems of patient injury and prolonged operation time caused by switching between balloon dilation catheters and angiography catheters have been solved. This achieves the integration of vascular dilation and angiography, reducing the use of contrast agents and radiation exposure.
Patent Information
- Authority / Receiving Office
- CN · China
- Patent Type
- Utility models(China)
- Current Assignee / Owner
- SUZHOU TIANHONGSHENGJIE MEDICAL INSTR CO LTD
- Filing Date
- 2025-04-22
- Publication Date
- 2026-05-05
AI Technical Summary
The current technology of switching between balloon dilation catheters and angiography catheters can cause harm to patients, increase operation time and infection risk, and requires multiple injections of contrast agents and prolonged exposure to radiation.
Design a balloon dilation catheter with an expansion balloon and a diagnostic balloon, featuring an independent lumen system that allows for simultaneous vascular dilation and angiography, reducing instrument changes, shortening procedure time, and minimizing radiation exposure time.
The balloon dilation catheter, which integrates dilation and angiography functions, reduces patient injury and infection risks, shortens procedure time, and reduces the harm of contrast agents to patients with renal insufficiency.
Smart Images

Figure CN224193916U_ABST
Abstract
Description
Technical Field
[0001] This utility model relates to the field of medical device technology, specifically to a balloon dilation catheter. Background Technology
[0002] In modern life, people sometimes develop physiological diseases in their blood vessels. One major problem is vascular stenosis. When a blood vessel narrows, a balloon is used to dilate the narrowed area to reduce the narrowing. After balloon dilation, an angiography catheter is used to determine the degree of improvement in the narrowing. This requires removing the balloon dilation catheter and then using the angiography catheter. For long lesions, this device needs to be switched multiple times.
[0003] Switching back and forth between balloon dilation catheters and angiography catheters can be harmful to patients. This process requires multiple injections of contrast agent and multiple X-ray examinations, prolonging the procedure and exposing doctors to prolonged radiation exposure. Furthermore, this switching increases the risk of infection for patients and adds to their financial burden. Utility Model Content
[0004] The technical problem to be solved by this utility model is to provide a balloon dilation catheter with stenosis detection function.
[0005] To achieve the above objectives, the technical solution adopted by this utility model is as follows:
[0006] A balloon dilation catheter includes a catheter and further includes a dilation balloon and a diagnostic balloon spaced apart along the length of the catheter. The catheter has a first lumen, a second lumen, and a third lumen, which are mutually isolated and all extend along the length of the catheter. The proximal end of the first lumen extends through the proximal end of the catheter, and the distal end of the first lumen communicates with the cavity of the dilation balloon. The proximal end of the second lumen extends through the proximal end of the catheter, and the distal end of the second lumen communicates with the cavity of the diagnostic balloon. The two ends of the third lumen extend through the proximal and distal ends of the catheter, respectively.
[0007] In some embodiments, the dilation balloon and the diagnostic balloon are sequentially spaced apart on the catheter from proximal to distal.
[0008] In some embodiments, the dilation balloon and the diagnostic balloon are sequentially spaced apart on the catheter from distal to proximal.
[0009] In some embodiments, the catheter is provided with a first filling hole at a position corresponding to the dilation balloon, which communicates the first lumen with the cavity of the dilation balloon, and a plurality of the first filling holes are provided at intervals along the length direction and / or circumferential direction of the catheter.
[0010] In some embodiments, a second filling hole is provided on the catheter at a position corresponding to the diagnostic balloon, allowing the second lumen to communicate with the cavity of the diagnostic balloon, and a plurality of the second filling holes are provided at intervals along the length direction and / or circumferential direction of the catheter.
[0011] In some embodiments, the dilation catheter further includes a tip disposed at the distal end of the catheter, the tip having a gradually decreasing diameter from the proximal end to the distal end, the tip having a fourth lumen penetrating the proximal and distal ends of the tip, the fourth lumen communicating with the third lumen.
[0012] In some embodiments, the cross-sections of the first cavity, the second cavity, and the third cavity are all circular, and the diameter of the third cavity is larger than the diameters of the first cavity and the second cavity.
[0013] In some embodiments, the dilatation balloon is a semi-compliant or non-compliant balloon, and the diagnostic balloon is a compliant balloon.
[0014] In some embodiments, the catheter is provided with a plurality of contrast rings at intervals along the length of the catheter at positions corresponding to the positions of the dilation balloon and the diagnostic balloon, and the catheter is also provided with scale markings along its length.
[0015] In some embodiments, the dilation catheter further includes a catheter seat and a stress diffusion tube. The catheter seat is disposed at the proximal end of the catheter, and the stress diffusion tube is sleeved outside the proximal end of the catheter. The proximal end of the stress diffusion tube is connected to the catheter seat, and the material hardness of the stress diffusion tube is less than that of the catheter seat.
[0016] The catheter hub has multiple fifth lumens extending through its proximal and distal ends, and each of the fifth lumens is respectively connected to the first lumen, the second lumen, and the third lumen;
[0017] Alternatively, multiple catheter hubs may be provided, each of which has a fifth lumen extending through its proximal and distal ends, and each fifth lumen is respectively connected to the first lumen, the second lumen, and the third lumen.
[0018] Due to the application of the above technical solution, this utility model has the following advantages compared with the prior art: The balloon dilation catheter of this utility model combines balloon dilation and angiography functions. When dilating a narrowed blood vessel, the first lumen is used to fill the balloon cavity with a filling medium. When it is necessary to diagnose the stenosis of the blood vessel before and after treatment, the second lumen is used to fill the balloon cavity with a contrast agent. Unlike the prior art, there is no need to replace the dilation catheter and the angiography catheter. This reduces the harm to the patient caused by replacing the dilation catheter and the angiography catheter, and also shortens the operation time and the doctor's exposure time to radiation. Moreover, the filled contrast agent does not enter the blood vessel, which reduces the harm of the contrast agent to the patient and is more suitable for patients with renal insufficiency. Attached Figure Description
[0019] Appendix Figure 1 This is a schematic diagram of the balloon dilation catheter in this embodiment;
[0020] Appendix Figure 2 This is a schematic cross-sectional view of the catheter in the balloon dilation catheter of this embodiment. Detailed Implementation
[0021] The technical solution of this utility model will now be clearly and completely described with reference to the accompanying drawings. Obviously, the described embodiments are only some, not all, of the embodiments of this utility model. Based on the embodiments of this utility model, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of this utility model.
[0022] In the description of this utility model, it should be noted that the terms "center," "upper," "lower," "left," "right," "vertical," "horizontal," "inner," and "outer," etc., indicate the orientation or positional relationship based on the orientation or positional relationship shown in the accompanying drawings, or the orientation or positional relationship commonly used when the product of this utility model is in use. They are used only for the convenience of describing this utility model and simplifying the description, and do not indicate or imply that the device or component referred to must have a specific orientation, or be constructed and operated in a specific orientation. Therefore, they should not be construed as limitations on this utility model. Furthermore, the terms "first," "second," and "third," etc., are only used to distinguish descriptions and should not be construed as indicating or implying relative importance.
[0023] Unless otherwise specified, the terms "proximal" and "distal" mentioned in this invention have the same meaning in terms of orientation. That is, in the state of use, the distal end is the end away from the operator, and the proximal end is the end closer to the operator. The operator operates the balloon dilation catheter at the proximal end.
[0024] like Figure 1As shown, the balloon dilation catheter of this utility model includes a catheter 1, a dilation balloon 2, a diagnostic balloon 3, a tip 4, and a catheter seat 5.
[0025] The dilatation balloon 2 is used to dilate the narrowed area of the blood vessel. The primary material of the dilatation balloon 2 is a semi-compliant or non-compliant balloon. The dilatation balloon 2 is not limited to a single balloon; it can be a cutting balloon, a pressure balloon, or other types of balloons. The diagnostic balloon 3 is used to diagnose the degree of vascular stenosis before and after treatment. Its primary material is a compliant balloon.
[0026] The catheter 1 has a first lumen 11, a second lumen 12, and a third lumen 13, which are mutually isolated and all extend along the length of the catheter 1. Figure 2 As shown, the dilation balloon 2 and the diagnostic balloon 3 are spaced apart on the catheter 1 along the length of the catheter 1.
[0027] The proximal end of the first lumen 11 extends through the proximal end of the catheter 1, and the distal end of the first lumen 11 communicates with the cavity of the dilating balloon 2. When dilating a narrowed blood vessel, a filling medium is introduced into the cavity of the dilating balloon 2 through the first lumen 11.
[0028] Specifically, such as Figure 1 As shown, a first filling hole 14 is provided at the distal end of the catheter 1 corresponding to the position of the dilatation balloon 2, connecting the first lumen 11 with the balloon cavity of the dilatation balloon 2. Multiple first filling holes 14 are provided at intervals along the length direction and / or circumferential direction of the catheter 1. The filling medium located in the first lumen 11 flows into the balloon cavity of the dilatation balloon 2 through each first filling hole 14 for inflating.
[0029] The proximal end of the second lumen 12 is connected to the proximal end of the catheter 1, and the distal end of the second lumen 12 is connected to the cavity of the diagnostic balloon 3. Contrast agent is injected into the cavity of the diagnostic balloon 3 through the second lumen 12 to diagnose vascular stenosis before or after treatment.
[0030] Specifically, such as Figure 1 As shown, a second filling port 15 is provided at the distal end of the catheter 1 corresponding to the position of the diagnostic balloon 3, connecting the second lumen 12 with the cavity of the diagnostic balloon 3. Multiple second filling ports 15 are spaced apart along the length and / or circumferential direction of the catheter 1. Contrast agent located in the second lumen 12 flows into the cavity of the diagnostic balloon 3 through each second filling port 15 to inflate it.
[0031] The third lumen 13 extends through the proximal and distal ends of catheter 1, respectively. The third lumen 13 is used to guide the guidewire during balloon dilation catheter delivery.
[0032] In this embodiment, the cross-sections of the first cavity 11, the second cavity 12, and the third cavity 13 are all circular, and the diameter of the third cavity 13 is larger than the diameters of the first cavity 11 and the second cavity 12.
[0033] On catheter 1, the dilation balloon 2 and the diagnostic balloon 3 are sequentially spaced alternately from proximal to distal. Alternatively, on catheter 1, the dilation balloon 2 and the diagnostic balloon 3 are sequentially spaced alternately from distal to proximal. That is, the positions of the dilation balloon 2 and the diagnostic balloon 3 on catheter 1 can be interchanged as needed. For example, if dilation of the stenotic area is required before diagnosis, the dilation balloon 2 is located distal to the diagnostic balloon 3. Conversely, if the degree of vascular stenosis needs to be diagnosed before dilation, the diagnostic balloon 3 is located distal to the dilation balloon 2.
[0034] The dilation catheter 2 also includes a tip 4 disposed at the distal end of the catheter 1. The tip 4 gradually decreases in diameter from the proximal end to the distal end, and the diameter of the proximal end of the tip 4 is the same as the diameter of the catheter 1. The tip 4 has a fourth lumen penetrating both the proximal and distal ends of the tip 4. The fourth lumen communicates with the third lumen 13 and is also used to deliver the guidewire during balloon dilation catheter delivery.
[0035] The catheter seat 5 is located at the proximal end of the catheter 1 and is used to provide an inlet for guidewire delivery and fluid filling. The catheter seat 5 can take several structural forms.
[0036] The catheter hub 5 has multiple fifth lumens extending through its proximal and distal ends, and each fifth lumen is connected to the first lumen 11, the second lumen 12 and the third lumen 13 respectively.
[0037] Alternatively, multiple catheter hubs 5 may be provided, each catheter hub 5 having a fifth lumen penetrating its proximal and distal ends, and each fifth lumen corresponding to and communicating with the first lumen 11, the second lumen 12 and the third lumen 13 respectively.
[0038] The balloon dilation catheter also includes a stress diffusion tube 6, which is sleeved on the outside of the proximal end of the catheter 1. The proximal end of the stress diffusion tube 6 is connected to the catheter seat 5, and its diameter gradually decreases from the proximal end to the distal end. The material hardness of the stress diffusion tube 6 is less than that of the catheter seat 1. By setting the stress diffusion tube 6, the catheter 1 can be prevented from kinking during the surgical procedure.
[0039] The distal end of catheter 1 is provided with a contrast ring 7, which is located on catheter 1 at the positions corresponding to dilation balloon 2 and diagnostic balloon 3. Multiple contrast rings 7 are spaced apart along the length of catheter 1. Catheter 1 is also provided with scale markings along its length, which are located outside the patient's body for observation by the physician during surgical procedures.
[0040] The main uses of this balloon dilation catheter fall into three categories: First, it is used when a narrowing has been diagnosed, but the patient has renal insufficiency or is allergic to contrast agents; second, it is used when the patient's renal function is impaired and the dosage of contrast agents needs to be strictly controlled; and third, it is used when the patient's renal function is intact, but it is necessary to further reduce the dosage of contrast agents and radiation to mitigate potential harm and damage to the patient.
[0041] There are two ways to use this balloon dilation catheter:
[0042] The first scenario involves patients with completely unknown stenosis and its degree. In this case, a balloon dilation catheter is used for diagnosis and dilation. The diagnostic balloon 3 is positioned distal to the dilation balloon 2 on catheter 1. The catheter is inserted into the patient's blood vessel via puncture. Contrast medium is sequentially inflated into the cavity of the diagnostic balloon 3 through the fifth and second lumen 12. The morphology of the diagnostic balloon 3 is then observed under CT scan to determine the degree of vascular stenosis. Afterward, the contrast medium is aspirated, and the dilation balloon 3 is moved to the location of the stenosis using the contrast ring 7 and the markings on catheter 1. The filling medium is then sequentially inflated into the cavity of the dilation balloon 2 through the fifth and first lumen 11 for dilation. After dilation, the filling medium is aspirated, catheter 1 is withdrawn to the initial diagnostic position, and contrast medium is again sequentially inflated into the cavity of the diagnostic balloon 3 through the fifth and second lumen 12 to assess the dilation effect. If satisfactory, the next stage of diagnosis and dilation is performed; if unsatisfactory, a second dilation is performed. After completing one dilation, the patient's blood vessels are diagnosed sequentially, and dilation is completed at all locations of vascular stenosis.
[0043] The second scenario involves angiography to pinpoint the location of the vascular stenosis. In this case, the dilation balloon 2 is positioned distal to the diagnostic balloon 3 on catheter 1. After the dilation catheter is advanced to the designated location, the filling medium is sequentially inflated into the balloon cavity of dilation balloon 2 through the fifth lumen and the first lumen 11 to dilate the stenosis. After dilation, the filling medium is aspirated, and the diagnostic balloon 3 is advanced to the stenosis location via the contrast ring 7 and the graduations on catheter 1. Contrast agent is sequentially inflated into the balloon cavity of diagnostic balloon 3 through the fifth lumen and the second lumen 12 to assess the improvement in stenosis. If satisfactory, the next dilation and diagnosis are performed; if unsatisfactory, a second dilation is performed.
[0044] The above embodiments are only for illustrating the technical concept and features of this utility model, and are intended to enable those skilled in the art to understand the content of this utility model and implement it accordingly. They should not be construed as limiting the scope of protection of this utility model. All equivalent changes or modifications made in accordance with the spirit and essence of this utility model should be included within the scope of protection of this utility model.
Claims
1. A balloon dilation catheter, comprising a catheter, characterized in that: The device also includes an expansion balloon and a diagnostic balloon spaced apart along the length of the catheter. The catheter has a first lumen, a second lumen, and a third lumen, which are isolated from each other and all extend along the length of the catheter. The proximal end of the first lumen extends through the proximal end of the catheter, and the distal end of the first lumen communicates with the cavity of the expansion balloon. The proximal end of the second lumen extends through the proximal end of the catheter, and the distal end of the second lumen communicates with the cavity of the diagnostic balloon. The two ends of the third lumen extend through the proximal and distal ends of the catheter, respectively.
2. The balloon dilation catheter according to claim 1, characterized in that: On the catheter, the dilation balloon and the diagnostic balloon are arranged sequentially and alternately from proximal to distal.
3. The balloon dilation catheter according to claim 1, characterized in that: On the catheter, the dilation balloon and the diagnostic balloon are arranged sequentially and alternately from distal to proximal.
4. The balloon dilation catheter according to claim 1, characterized in that: The catheter is provided with a first filling hole at the position corresponding to the dilatation balloon, so that the first lumen is connected to the cavity of the dilatation balloon. Multiple first filling holes are provided at intervals along the length direction and / or circumferential direction of the catheter.
5. The balloon dilation catheter according to claim 1, characterized in that: The catheter is provided with a second filling hole at a position corresponding to the diagnostic balloon, which enables the second lumen to communicate with the cavity of the diagnostic balloon. Multiple second filling holes are provided at intervals along the length direction and / or circumferential direction of the catheter.
6. The balloon dilation catheter according to claim 1, characterized in that: The dilation catheter further includes a tip disposed at the distal end of the catheter, the tip having a gradually decreasing diameter from the proximal end to the distal end, the tip having a fourth lumen penetrating the proximal and distal ends of the tip, the fourth lumen communicating with the third lumen.
7. The balloon dilation catheter according to claim 1, characterized in that: The first cavity, the second cavity, and the third cavity all have circular cross-sections, and the diameter of the third cavity is larger than the diameters of the first cavity and the second cavity.
8. The balloon dilation catheter according to claim 1, characterized in that: The dilatation balloon is a semi-compliant or non-compliant balloon, and the diagnostic balloon is a compliant balloon.
9. The balloon dilation catheter according to claim 1, characterized in that: The catheter has multiple contrast rings spaced apart along its length at positions corresponding to the dilation balloon and the diagnostic balloon. The catheter also has scale markings along its length.
10. The balloon dilation catheter according to claim 1, characterized in that: The dilation catheter also includes a catheter seat and a stress diffusion tube. The catheter seat is disposed at the proximal end of the catheter, and the stress diffusion tube is sleeved on the outside of the proximal end of the catheter. The proximal end of the stress diffusion tube is connected to the catheter seat, and the material hardness of the stress diffusion tube is less than that of the catheter seat. The catheter hub has multiple fifth lumens extending through its proximal and distal ends, and each of the fifth lumens is respectively connected to the first lumen, the second lumen, and the third lumen; Alternatively, multiple catheter hubs may be provided, each of which has a fifth lumen extending through its proximal and distal ends, and each fifth lumen is respectively connected to the first lumen, the second lumen, and the third lumen.