An intracranial balloon dilatation catheter
By designing a high-flex end and detection unit in the balloon catheter, the problem of balancing the catheter between pushability and flexibility is solved, and real-time feedback is provided to improve operational safety.
Patent Information
- Application Number
- CN202411621759.1
- Authority / Receiving Office
- CN · China
- Patent Type
- Patents(China)
- Current Assignee / Owner
- Filing Date
- 2024-11-14
- Publication Date
- 2025-02-25
- Estimated Expiration
- 2044-11-14
AI Technical Summary
The existing balloon catheters are difficult to balance between pushability and flexibility, and lack feedback structures, making it difficult for users to sense the bending or over-squeezing of the ends of the catheter in a timely manner.
A intracranial balloon dilation catheter with a high flexible end is designed, using a special connection structure between a separate end tube and a distal balloon pin. The end of the inner tube has a bellows and a tube at the end tube. A detection unit is introduced, including side and end pressure sensors.
The high flexibility of the catheter end is achieved, the overall pushability of the catheter is enhanced, and real-time feedback is provided through the detection unit to avoid damage to the human body due to improper operation.
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Abstract
Description
Technical Field
[0001] The present application relates to the field of medical devices, and in particular to an intracranial balloon dilatation catheter, and in particular to an intracranial balloon dilatation catheter with a highly flexible end. Background Art
[0002] A balloon dilatation catheter is a medical device composed of an inner tube, an outer tube and a balloon, which can be inserted into a blood vessel to inflate the balloon, thereby expanding the blood vessel. When in use, it is generally used in conjunction with guide wires, sheaths and other components. Since it needs to be inserted into the blood vessels of the human body during use, it is hoped that it has good pushability. However, since the end of the catheter will touch the inner wall of the blood vessel, in order to avoid damage to the blood vessels in the human body, it is hoped that the end of the balloon catheter has good flexibility. Therefore, on the one hand, it is hoped that the balloon catheter has good pushability as a whole, and on the other hand, it is hoped that the end of the balloon catheter has good flexibility. However, the existing balloon catheters are sometimes difficult to balance and meet the requirements in these two aspects. In addition, when the existing balloon catheters are in use, due to the lack of feedback structure at the end of the balloon catheter, timely feedback cannot be obtained when the user uses too much force or the end of the balloon catheter is excessively bent. Summary of the invention
[0003] Purpose of the invention: The present application aims to overcome the defects of the prior art and provide an intracranial balloon dilatation catheter with a highly flexible end.
[0004] Technical solution: A balloon dilatation catheter, comprising an inner tube, an outer tube, a balloon and an end tube; the inner tube is located inside the outer tube, the balloon comprises a balloon body, a front end tube pin of the balloon connected to the balloon body and a rear end tube pin of the balloon connected to the balloon body, the rear end tube pin of the balloon is fixedly connected to the end of the outer tube, the front end tube pin of the balloon is folded, comprising a first tube pin, a second tube pin surrounded by the first tube pin, a third tube pin surrounded by the second tube pin, a first annular transition portion connecting the first tube pin and the second pin, and a tube pin connecting the second pin and the third tube pin. A third transition portion is an annular portion having three pins; the end tube comprises an end tube body, an outer tube connected to the end tube body and an inner tube connected to the end tube body, the outer tube surrounds the first pin and is fixedly connected to the first pin, the inner tube is located between the second pin and the third pin, and is fixedly connected to both the second pin and the third pin; the end of the inner tube is located between the first pin and the second pin, and is fixedly connected to both the first pin and the second pin; an injection tube for injecting gas into the balloon is installed between the inner tube and the outer tube.
[0005] Furthermore, the gas injection pipe has a plurality of gas outlet holes.
[0006] Furthermore, the end of the inner tube is connected to a corrugated tube, and the corrugated tube is located between the first tube pin and the second tube pin.
[0007] Furthermore, a first developing ring is fixed to one end of the bellows, and a second developing ring is fixed to the other end, and both the first developing ring and the second developing ring are located between the bellows and the first pin.
[0008] Thereby, the front end of the balloon catheter is conveniently positioned.
[0009] Furthermore, the inner tube is provided with a third developing ring, and the third developing ring faces the position where the rear end pin of the balloon is located.
[0010] Furthermore, the length of the first developing ring is greater than or equal to twice the length of the second developing ring.
[0011] Therefore, it is easy to identify the first developing ring and the second developing ring, and judge whether the front end of the balloon catheter is excessively bent according to the relative positions of the two developing rings.
[0012] Furthermore, the end of the end pipe body has a rounded chamfer.
[0013] Thereby increasing the pushability of the end tube.
[0014] Furthermore, the first pin and the external insert tube are fixed by adhesive or laser welding.
[0015] Furthermore, the second pin, the third pin and the inner tube are fixed by adhesive.
[0016] Furthermore, the first tube pin is fixed to the outer side of the inner tube by adhesive; the second tube pin is fixed to the inner side of the inner tube by adhesive; and the third tube pin is fixed to the annular limiting plate by adhesive.
[0017] Furthermore, during assembly, the wires of the detection unit are coated with sealant and pass through the wire channels and wire perforations, and the corresponding positions of the front end pins of the balloon are coated with a glue layer, and the inner tube, end tube, front end pins of the balloon and the detection unit are assembled and fixed accordingly.
[0018] Furthermore, it also includes a detection unit, which is installed between the second tube pin and the third tube pin; the inner side of the inner tube is connected to an annular limit plate through an annular connecting portion, and an annular slot is formed between the annular limit plate and the inner tube, and the second transition portion, an end of the second tube pin close to the second transition portion, and an end of the third tube pin close to the second transition portion are all located in the annular slot; the detection unit includes an annular abutment plate, a plurality of positioning rods connected to the annular abutment plate, a first mounting plate connected to the annular abutment plate, and a second mounting plate connected to and perpendicular to the first mounting plate, side pressure sensors are installed on both sides of the first mounting plate, and an end pressure sensor is installed on the second mounting plate, and the end of the inner tube has a plurality of positioning holes inserted by the positioning rods.
[0019] Furthermore, the side pressure sensor and the end pressure sensor are both strain gauge pressure sensors.
[0020] Thus, the side pressure sensor can sense the pressure generated when the end tube is excessively bent; and the end pressure sensor can sense the pressure generated when the end tube is excessively squeezed axially.
[0021] Furthermore, the inner tube has a wire channel, the second tube pin has a wire through-hole communicating with the wire channel, and the detection unit further includes a sensor wire passing through the wire through-hole and the wire channel.
[0022] Furthermore, sealant is filled between the wire channel and the sensor wire.
[0023] Furthermore, the number of the positioning rods and the number of the positioning holes are equal, and are both greater than or equal to 6.
[0024] Furthermore, the length of the corrugated tube is greater than or equal to 0.5 cm and less than or equal to 2 cm.
[0025] Furthermore, the hardness of the end tube is less than the hardness of the inner tube; the balloon body, the front end tube pin of the balloon and the rear end tube pin of the balloon are made of the same material.
[0026] Beneficial effect: The balloon dilatation catheter of the present application adopts a separate end tube, and a special connection structure is passed between the end tube and the distal end pin of the balloon, and the end of the inner tube has a corrugated tube, so that the end tube has better flexibility, thereby achieving better flexibility, and the balloon catheter as a whole has better pushing performance.
[0027] The balloon catheter of the present application has two developing rings at the bellows, so as to facilitate the development and positioning of the front end of the balloon catheter, and the deformation degree of the bellows can be judged by the relative positions of the two developing rings.
[0028] The balloon catheter of the present application has a detection unit, so that when a large bending or squeezing occurs between the terminal tube and the front end of the inner tube, it can be sensed in time, and the feedback is given to the operator in time to give feedback to the operator's operation. BRIEF DESCRIPTION OF THE DRAWINGS
[0029] Figure 1 This is a schematic diagram of a balloon dilatation catheter;
[0030] Figure 2 It is a cross-sectional schematic diagram of a balloon dilatation catheter;
[0031] Figure 3 for Figure 2 A1 area enlarged view;
[0032] Figure 4 for Figure 2 A2 area enlarged view;
[0033] Figure 5 This is a schematic diagram of the separation of balloon dilatation catheter components;
[0034] Figure 6 for Figure 5 Enlarged view of area B;
[0035] Figure 7 It is a cross-sectional schematic diagram of the separation of balloon dilatation catheter components;
[0036] Figure 8 for Figure 7 Enlarged view of the middle C1 area;
[0037] Fig. 9 for Figure 7 Enlarged view of the C2 area. DETAILED DESCRIPTION
[0038] Reference numerals:
[0039] 1 outer tube;
[0040] 2 inner tube; 2.1 annular connecting part; 2.2 annular limiting plate; 2.3 bellows; 2.4 first developing ring; 2.5 second developing ring; 2.6 wire channel;
[0041] 3 end tube; 3.1 outer insert tube; 3.2 inner insert tube; 3.3 end tube body; 3.2.1 positioning socket;
[0042] 4 Balloon; 4.1 Balloon front pin; 4.1.1 First pin; 4.1.2 Second pin; 4.1.3 Third pin; 4.1.4 First transition part; 4.1.5 Second transition part; 4.2 Balloon rear pin; 4.3 Balloon body; 4.4 Wire perforation;
[0043] 5. Injection pipe; 5.1 Air outlet;
[0044] 6 Detection unit; 6.1 annular abutment plate; 6.2 first mounting plate; 6.3 second mounting plate; 6.4 side pressure sensor; 6.5 end pressure sensor; 6.6 positioning rod.
[0045] As shown in the figure, an intracranial balloon dilatation catheter with a highly flexible end portion comprises an inner tube 2, an outer tube 1, a balloon 4 and an end tube 3; the inner tube 2 is located inside the outer tube 1, the balloon 4 comprises a balloon body 4.3, a balloon front end pin 4.1 connected to the balloon body 4.3 and a balloon rear end pin 4.2 connected to the balloon body 4.3, the balloon rear end pin 4.2 being fixedly connected to the end of the outer tube 1, the balloon front end pin 4.1 is in a folded shape, comprising a first pin 4.1.1, a second pin 4.1.2 surrounded by the first pin 4.1.1, a third pin 4.1.3 surrounded by the second pin 4.1.2, an annular first transition portion 4.1.4 connecting the first pin 4.1.2 and the second pin 4.1.2, and a connecting portion 4.1.2 and the third pin 4.1.3; The annular second transition portion 4.1.5 of the tube pin 4.1.3; the end tube 3 includes an end tube body 3.3, an outer tube 3.1 connected to the end tube body 3.3 and an inner tube 3.2 connected to the end tube body 3.3, the outer tube 3.1 surrounds the first tube pin 4.1.1 and is fixedly connected to the first tube pin 4.1.1, the inner tube 3.2 is located between the second tube pin 4.1.2 and the third tube pin 4.1.3, and is fixedly connected to both the second tube pin 4.1.2 and the third tube pin 4.1.3; the end of the inner tube 2 is located between the first tube pin 4.1.1 and the second tube pin 4.1.2, and is fixedly connected to both the first tube pin 4.1.1 and the second pin 4.1.2; an injection tube 5 for injecting gas into the balloon 4 is installed between the inner tube 2 and the outer tube 1. The end of the inner tube 2 is connected with a bellows 2.3, and the bellows 2.3 is located between the first pin 4.1.1 and the second pin 4.1.2; a first developing ring 2.4 is fixed at one end of the bellows 2.3, and a second developing ring 2.5 is fixed at the other end, and the first developing ring 2.4 and the second developing ring 2.5 are both located between the bellows 2.3 and the first pin 4.1.1; the length of the first developing ring 2.4 is greater than or equal to twice the length of the second developing ring 2.5. The end of the end tube body 3.3 has a rounded chamfer.
[0046] The balloon dilatation catheter of the present application also includes a detection unit 6, which is installed between the second pin 4.1.2 and the third pin 4.1.3; the inner side of the inner tube 2 is connected to an annular limit plate 2.2 through an annular connecting portion 2.1, and an annular slot is formed between the annular limit plate 2.2 and the inner tube 2, and the second transition portion 4.1.5, the end of the second pin 4.1.2 close to the second transition portion 4.1.5, and the end of the third pin 4.1.3 close to the second transition portion 4.1.5 are all located in the annular slot. The detection unit includes an annular abutment plate 6.1, a plurality of positioning rods 6.6 connected to the annular abutment plate 6.1, a first mounting plate 6.2 connected to the annular abutment plate 6.1, and a second mounting plate 6.3 connected to and perpendicular to the first mounting plate 6.2. Side pressure sensors 6.4 are installed on both sides of the first mounting plate 6.2, and an end pressure sensor 6.5 is installed on the second mounting plate 6.3. The end of the inner tube 3.2 has a plurality of positioning holes 3.2.1 inserted by the positioning rods 6.6. The inner tube 2 has a wire channel 2.6, and the second tube pin 4.1.2 has a wire through-hole 4.4 connected to the wire channel 2.6. The detection unit also includes a sensor wire passing through the wire through-hole 4.4 and the wire channel 2.6; the wire channel 2.6 and the sensor wire are filled with sealant. The number of the positioning rods 6.6 and the positioning holes 3.2.1 is equal, and both are greater than or equal to 6. The length of the corrugated tube 2.3 is greater than or equal to 0.5 cm and less than or equal to 2 cm. The hardness of the end tube 3 is less than the hardness of the inner tube 2. The balloon body 4.3, the front end pin 4.1 and the rear end pin 4.2 are made of the same material.
[0047] As shown in the figure, the balloon dilatation catheter of the present application has a connection method between the end tube and the balloon front end pin of the balloon and the front end of the inner tube, which makes the connection between the end tube, the balloon front end pin and the end of the inner tube more stable through the folding of the balloon front end pin. In addition, the outer insert is in the outermost layer, which avoids the problem of a step portion with a small front end and a large rear end at the connection between the end tube and the balloon (a step portion with a small front end and a large rear end is likely to have an adverse effect on the inner wall of the blood vessel when pushing, so the structure of this step portion will affect the pushing performance of the balloon catheter), and the outer insert of the end tube is in the outermost layer, thereby increasing the pushing performance of the balloon catheter.
[0048] In addition, the front end pins of the balloon are folded on both sides to form a space that can accommodate the bellows and the detection unit. By arranging the bellows at the front end, the bellows has a certain bendable shape and a certain scalability in the axial direction, so that the terminal tube, the bellows and the front end of the inner tube have better flexibility. In addition, there is a detection unit in the slot, so that when the detection unit is excessively bent to the side or excessively squeezed in the axial direction, the pressure sensor can detect it and give feedback to the operator, so that the operator can be reminded to avoid damage to the human body caused by improper operation.
[0049] Although the present invention has been illustrated and described with respect to the preferred embodiments, it will be appreciated by those skilled in the art that various changes and modifications may be made to the present invention without departing from the scope of the present invention as defined by the claims.
Claims
1. An intracranial balloon dilatation catheter with a highly flexible end, characterized in that: The balloon comprises an inner tube, an outer tube, a balloon and an end tube; the inner tube is located inside the outer tube, the balloon comprises a balloon body, a front end pin connected to the balloon body and a rear end pin connected to the balloon body, the rear end pin is fixedly connected to the end of the outer tube, the front end pin is folded, and comprises a first pin, a second pin surrounded by the first pin, a third pin surrounded by the second pin, a first annular transition portion connecting the first pin and the second pin, and a second annular transition portion connecting the second pin and the third pin; The end tube comprises an end tube body, an outer insert tube connected to the end tube body, and an inner insert tube connected to the end tube body, the outer insert tube surrounds the first tube pin and is fixedly connected to the first tube pin, the inner insert tube is located between the second tube pin and the third tube pin, and is fixedly connected to both the second tube pin and the third tube pin; the end of the inner tube is located between the first tube pin and the second tube pin, and is fixedly connected to both the first tube pin and the second pin; an injection tube for injecting gas into the balloon is installed between the inner tube and the outer tube; The end of the inner tube is connected to a bellows, which is located between the first pin and the second pin; a first developing ring is fixed to one end of the bellows, and a second developing ring is fixed to the other end, and both the first developing ring and the second developing ring are located between the bellows and the first pin; the length of the first developing ring is greater than or equal to twice the length of the second developing ring.
2. The intracranial balloon dilatation catheter with a highly flexible end portion according to claim 1, characterized in that: The end of the end tube body has a rounded chamfer.
3. The intracranial balloon dilatation catheter with a highly flexible end portion according to claim 1, characterized in that: It also includes a detection unit, which is installed between the second tube pin and the third tube pin; the inner side of the inner tube is connected to an annular limit plate through an annular connecting portion, and an annular slot is formed between the annular limit plate and the inner tube, and the second transition portion, an end of the second tube pin close to the second transition portion, and an end of the third tube pin close to the second transition portion are all located in the annular slot; the detection unit includes an annular abutment plate, a plurality of positioning rods connected to the annular abutment plate, a first mounting plate connected to the annular abutment plate, and a second mounting plate connected to and perpendicular to the first mounting plate, side pressure sensors are installed on both sides of the first mounting plate, and an end pressure sensor is installed on the second mounting plate, and the end of the inner tube has a plurality of positioning holes inserted by the positioning rods.
4. The intracranial balloon dilatation catheter with a highly flexible end portion according to claim 3, characterized in that: The inner tube has a wire channel, the second tube pin has a wire through-hole communicating with the wire channel, and the detection unit further includes a sensor wire passing through the wire through-hole and the wire channel; The space between the wire channel and the sensor wire is filled with sealant.
5. The intracranial balloon dilatation catheter with a highly flexible end portion according to claim 3, characterized in that: The number of the positioning rods and the number of the positioning holes are equal, and are both greater than or equal to 6.
6. The intracranial balloon dilatation catheter with a highly flexible end portion according to claim 1, characterized in that: The length of the corrugated tube is greater than or equal to 0.5 cm and less than or equal to 2 cm.
7. The intracranial balloon dilatation catheter with a highly flexible end portion according to claim 1, characterized in that: The hardness of the end tube is less than that of the inner tube; the balloon body, the front end tube pin of the balloon and the rear end tube pin of the balloon are made of the same material.
Citation Information
Patent Citations
Balloon catheter and manufacturing method thereof
CN110420375A