Balloon dilatation catheter

Abstract

The invention discloses a balloon dilatation catheter, and relates to the technical field of interventional therapy instruments, the balloon dilatation catheter comprises a catheter, a bearing, an anchoring balloon and a nicked balloon, the bearing comprises a bearing inner ring connected with the catheter, and a bearing outer ring sleeving the periphery of the bearing inner ring and capable of circumferentially rotating relative to the bearing inner ring; the anchoring balloon is connected to the bearing outer ring and can expand in the radial direction relative to the catheter, and the anchoring balloon can be anchored in the blood vessel in the expansion state; the nicking balloon is located at the far end of the anchoring balloon and can expand in the radial direction relative to the catheter, and the nicking balloon can conduct extrusion nicking on plaques on the inner wall of the blood vessel in the expansion state. Due to the fact that the bearing outer ring and the bearing inner ring can relatively rotate in the circumferential direction, when the anchoring balloon is anchored, the catheter can rotate relative to the anchoring balloon, the deflection angle of the nicking balloon can be adjusted by rotating the catheter, the nicking balloon can conduct extrusion nicking on plaques at different positions in the circumferential direction of the inner wall of a blood vessel in the multiple nicking processes, and the nicking effect is improved. And the dilation effect of the balloon dilatation catheter on vascular stenosis is improved.

Description

Technical Field

[0001] This invention relates to the field of interventional therapy device technology, specifically to a balloon dilation catheter. Background Technology

[0002] In interventional treatment of arterial occlusion, an expandable scoring balloon is typically used to dilate the blocked artery. The protrusions on the periphery of the scoring balloon are used to compress the plaque on the inner wall of the artery, thereby restoring arterial patency and improving blood flow.

[0003] In existing scoring balloon dilation catheters, one or more scoring elements are fixedly disposed around the periphery of the scoring balloon. When the scoring balloon inflates, the externally protruding scoring elements can locally compress and score plaque on the vascular wall. Because the catheter is made of a relatively soft polymer material, it is difficult to rotate the scoring balloon to the corresponding angle by twisting the catheter externally. Therefore, existing scoring balloons have poor scoring effect on vascular wall plaque.

[0004] Therefore, how to improve the scoring effect of the scoring balloon is a technical problem that urgently needs to be solved by those skilled in the art. Summary of the Invention

[0005] In view of this, the present invention provides a balloon dilation catheter to solve the problems of existing balloon dilation catheters, such as difficulty in rotating the scoring balloon and poor scoring effect on plaque on the vascular wall.

[0006] To solve the above-mentioned technical problems, the technical solution of the present invention is as follows:

[0007] A balloon dilation catheter, comprising: catheter; The bearing includes an inner bearing ring fixedly connected to the conduit and an outer bearing ring sleeved and connected to the outer circumference of the inner bearing ring and capable of rotating circumferentially relative to the inner bearing ring. An anchoring balloon is connected to the outer ring of the bearing and can expand radially relative to the catheter. The anchoring balloon can be anchored in the blood vessel when expanded. A scoring balloon is connected to the catheter and located at the distal end of the anchoring balloon. The scoring balloon has scoring elements on its outer periphery. The scoring balloon can expand radially relative to the catheter, and in the expanded state, the scoring balloon can compress and score plaque on the inner wall of the blood vessel.

[0008] Furthermore, the bearing also includes a plurality of balls disposed between the inner ring and the outer ring of the bearing, the plurality of balls creating a gap between the inner ring and the outer ring of the bearing.

[0009] Furthermore, the outer periphery of the scoring balloon is provided with a plurality of scoring elements, which are arranged at intervals along the circumference of the scoring balloon, and the length direction of the plurality of scoring elements extends along the axial direction of the scoring balloon; when the scoring balloon is in an expanded state, the plurality of scoring elements can compress and score the plaque on the inner wall of the blood vessel.

[0010] Furthermore, the catheter has an independent anchoring balloon filling chamber and a notched balloon filling chamber inside. The notched balloon filling chamber is connected to the inner lumen of the notched balloon. An inflation tube is connected to the proximal end of the anchoring balloon. One end of the inflation tube is connected to the anchoring balloon filling chamber, and the other end is connected to the inner lumen of the anchoring balloon.

[0011] Furthermore, the filling tube and the conduit are welded and sealed at their contact points, and the filling tube and the anchoring balloon are welded and sealed at their contact points.

[0012] Furthermore, the catheter includes a multi-lumen tube, the interior of which is provided with a guidewire lumen for the guidewire to pass through. The guidewire lumen, the anchoring balloon filling lumen, and the notched balloon filling lumen are three independent cavities inside the catheter.

[0013] Furthermore, the anchoring balloon inflation chamber and the notched balloon inflation chamber are located in different regions on the outer periphery of the guidewire chamber.

[0014] Furthermore, the catheter also includes an inner core tube and an outer tube connected to the multi-lumen tube; the inner core tube is sealed to the multi-lumen tube, and the inner lumen of the inner core tube communicates with the guidewire lumen; the proximal end of the outer tube is sealed to the distal end of the multi-lumen tube and coaxially sleeved on the outer periphery of the inner core tube, the cavity between the outer tube and the inner core tube is the distal lumen, the scoring balloon is connected to the outer tube, the distal end of the multi-lumen tube has an opening communicating with the scoring balloon inflation chamber and the distal lumen, and the distal lumen communicates with the scoring balloon inflation chamber and the inner lumen of the scoring balloon.

[0015] Furthermore, the inner core tube includes a proximal portion extending into the guide wire cavity of the multi-lumen tube, and the proximal portion of the inner core tube is sealed to the cavity wall of the guide wire cavity; the bearing inner ring is sleeved and fixed on the outer periphery of the distal end of the multi-lumen tube, and the proximal portion of the inner core tube is supported inside the tube section of the multi-lumen tube in which the bearing inner ring is sleeved.

[0016] Furthermore, the proximal end of the catheter is connected to a catheter seat, which has an internal hollow structure. The catheter seat is provided with a scoring balloon inflation / deflation port communicating with the scoring balloon inflation chamber, an anchoring balloon inflation / deflation port communicating with the anchoring balloon inflation chamber, and a guidewire port communicating with the guidewire lumen.

[0017] The balloon dilation catheter provided by the present invention has an additional bearing located near the proximal end of the scored balloon on the catheter. The inner ring of the bearing is fixed to the outer circumference of the catheter, and the balloon is fixed to the outer ring of the bearing. Since the outer ring of the bearing can rotate freely in the circumferential direction relative to the inner ring of the bearing, when the anchoring balloon is dilated and anchored, the catheter and the scored balloon can move in the circumferential direction relative to the anchoring balloon. When the catheter reaches the plaque location within the blood vessel, the scoring balloon is first inflated to inflate it, causing it to compress and score the plaque on the vessel wall. Next, the anchoring balloon is inflated and anchored to the vessel wall. Then, the scoring balloon is depressurized, allowing the catheter to be rotated to adjust its deflection angle without significant change in its axial position. Finally, the scoring balloon is inflated again, enabling it to compress and score plaque at different circumferential locations on the vessel wall, greatly improving the dilation effect of the scoring balloon on vascular stenosis symptoms during balloon angioplasty. Attached Figure Description

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

[0019] Figure 1 This is a three-dimensional structural diagram of the balloon dilation catheter in an embodiment of the present invention; Figure 2 This is a front view of the balloon dilation catheter in an embodiment of the present invention, where both the anchor balloon and the notched balloon are in the dilated state. Figure 3 for Figure 2 A sectional view; Figure 4 for Figure 3 Enlarged view of point A in the middle; Figure 5 This is a front view of the balloon dilation catheter in an embodiment of the present invention, with the anchor balloon in a contracted state and the notched balloon in a dilated state. Figure 6 for Figure 5 A sectional view; Figure 7 This is a front view of the balloon dilation catheter in an embodiment of the present invention, with the anchor balloon in the dilated state and the notched balloon in the contracted state. Figure 8 for Figure 7 A sectional view.

[0020] Explanation of reference numerals in the attached diagram: 1. Catheter; 11. Multi-lumen tube; 11a. Anchoring balloon filling chamber; 11b. Scored balloon filling chamber; 11c. Guidewire lumen; 12. Inner core tube; 121. Proximal portion of the inner core tube; 13. Outer tube; 14. Distal lumen; 2. Bearing; 21. Inner ring of bearing; 22. Outer ring of bearing; 23. Ball bearing; 3. Anchoring balloon; 4. Scored balloon; 41. Scored element; 5. Inflation tube; 6. Catheter hub; 6a. Anchoring balloon inflation / deflation port; 6b. Scored balloon inflation / deflation port; 6c. Guidewire port. Detailed Implementation

[0021] The technical solution of the present invention 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 the present invention. Based on the embodiments of the present invention, all other embodiments obtained by those skilled in the art without creative effort are within the scope of protection of the present invention.

[0022] In the description of this application, it should be understood that the terms "proximal" and "distal" throughout refer to near and far relative to the operator. In use, the end closer to the doctor or operator is the "proximal" end, i.e., the end where the operator is located, and the end farther from the doctor or operator is the "distal" end, i.e., the end where the balloon is located. The above descriptions of orientation are for ease of description and simplification only, and do not indicate or imply that the device or element 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 application.

[0023] In the description of this application, it should be noted that the terms "installation," "connection," and "linking" should be interpreted broadly, referring to direct connection, indirect connection through an intermediate medium, or internal connection between two components. Those skilled in the art can understand the specific meaning of these terms in the invention based on the specific circumstances.

[0024] like Figure 1 and Figure 2 The illustrated balloon dilation catheter includes a catheter 1, a bearing 2, an anchoring balloon 3, a scoring balloon 4, an inflation tube 5, and a catheter seat 6. The bearing 2 is connected to the outer periphery of the distal end of the catheter 1. The anchoring balloon 3 is fixedly connected to the outer periphery of the bearing 2. The scoring balloon 4 is fixedly connected to the outer periphery of the distal end of the catheter 1, with the scoring balloon 4 located distal to the anchoring balloon 3. The catheter seat 6 is connected to the proximal end of the catheter 1. The anchoring balloon 3 and the scoring balloon 4 can independently expand radially relative to the catheter 1. In the expanded state, the anchoring balloon 3 can anchor within the blood vessel, and the scoring balloon 4 can compress and score plaque on the inner wall of the blood vessel in the expanded state.

[0025] like Figure 1 and Figure 2As shown, the scoring balloon 4 is spindle-shaped in its inflated state. Three scoring elements 41 are provided on the outer periphery of the middle portion of the scoring balloon 4. These three scoring elements 41 are arranged circumferentially and spaced apart, with their length extending along the axial direction of the scoring balloon 4. Specifically, each scoring element 41 is a blunt, hard protrusion extending outward from the outer wall of the scoring balloon 4. When the scoring balloon 4 is inflated, the blunt, hard protrusion, through a cohesive effect, compresses and reshapes plaques and calcified lesions outward, resulting in more thorough compression of the plaques and calcified lesions on the vascular wall. Compared to a cutting balloon with a cutting blade on its periphery, this reduces excessive stretching and damage to normal vascular wall tissue. It is understood that the number of scoring elements 41 on the outer periphery of the scoring balloon 4 is not limited to three; other numbers are also possible. The scoring elements 41 can also be sharp, hard protrusions that can both compress and cut plaques.

[0026] like Figure 2 , Figure 3 and Figure 4 As shown, the proximal end of the anchoring balloon 3 is connected to an inflation tube 5, which is a hollow tube. One end of the inflation tube 5 communicates with the inflation cavity 11a of the anchoring balloon inside the catheter 1, and the other end of the inflation tube 5 communicates with the inner lumen of the anchoring balloon 3. The inflation medium can enter the inner lumen of the anchoring balloon 3 through the inflation cavity 11a of the anchoring balloon inside the catheter 1 and the inflation tube 5, causing the anchoring balloon 3 to expand. Specifically, the proximal end of the inflation tube 5 is welded and sealed to the catheter 1 at the connection point, and the distal end of the inflation tube 5 is welded and sealed to the anchoring balloon 3 at the connection point to ensure a seal at the connection points of the two ends of the inflation tube 5.

[0027] like Figure 2 , Figure 3 and Figure 4 As shown, catheter 1 includes a multi-lumen tube 11, inside which are independently located an anchoring balloon inflation chamber 11a, a notched balloon inflation chamber 11b, and a guidewire chamber 11c. The guidewire chamber 11c is centrally located within the multi-lumen tube 11, allowing the guidewire to pass through. The anchoring balloon inflation chamber 11a and the notched balloon inflation chamber 11b are located in different areas around the guidewire chamber 11c. The distal end of the anchoring balloon inflation chamber 11a is closed, while the distal end of the notched balloon inflation chamber 11b is open. The notched balloon inflation chamber 11b communicates with the inner lumen of the notched balloon 4, and the anchoring balloon inflation chamber 11a communicates with the inner lumen of the anchoring balloon 3 via an inflation tube 5. Because the anchoring balloon inflation chambers 11a and 11b are independently located, the anchoring balloon 3 and the notched balloon 4 can be independently inflated and deflated.

[0028] like Figure 2 , Figure 3 and Figure 4As shown, the bearing 2 includes an inner bearing ring 21 and an outer bearing ring 22. The inner bearing ring 21 is fixedly connected to the outer periphery of the distal end of the multi-cavity tube 11. The outer bearing ring 22 is sleeved and connected to the outer periphery of the inner bearing ring 21. The outer bearing ring 22 can maintain relative axial fixation and relative circumferential rotation with the inner bearing ring 21. The anchoring ball 3 is fixedly connected to the outer periphery of the outer bearing ring 22. In some embodiments, the bearing 2 further includes a plurality of balls 23 disposed between the inner ring 21 and the outer ring 22. These balls 23 allow the outer ring 22 to rotate circumferentially relative to the inner ring 21 without disengaging from it. Simultaneously, the balls 23 create a gap between the inner and outer rings, allowing blood flow between the ends of the balloon 3 when it is inflated and anchored to the vessel wall. This prevents complete vascular occlusion during balloon dilation, providing sufficient surgical time for the balloon angioplasty procedure. This allows subsequent manipulation of the catheter 1 and re-inflation of the scored balloon 4 to be performed within a safe surgical timeframe. In alternative embodiments, the bearing 2 can be a sliding bearing without balls, in which case the inner ring 21 is the sliding bearing, and the outer ring 22 is a sleeve fitted around the outer circumference of the sliding bearing.

[0029] like Figure 2 , Figure 3 and Figure 4 As shown, catheter 1 also includes an inner core tube 12 and an outer tube 13 connected to a multi-lumen tube 11. The inner core tube 12 is sealed to the distal end of the multi-lumen tube 11, and the inner lumen of the inner core tube 12 communicates with the guidewire lumen 11c of the multi-lumen tube 11. The proximal end of the outer tube 13 is sealed to the distal end of the multi-lumen tube 11, and the outer tube 13 is coaxially sleeved on the outer periphery of the inner core tube 12. The cavity between the outer tube 13 and the inner core tube 12 is the distal lumen 14. A notched balloon 4 is connected to the outer tube 13. The distal end of the multi-lumen tube 11 has an opening communicating with the notched balloon inflation chamber 11b and the distal lumen 14. The distal lumen 14 communicates with the notched balloon inflation chamber 11b and the inner lumen of the notched balloon 4. The filling medium can enter the inner cavity of the scarified balloon 4 through the distal lumen 14 between the scarified balloon filling cavity 11b in the multi-lumen tube 11, the outer tube 13 and the inner core tube 12, causing the scarified balloon 4 to expand.

[0030] like Figure 3 and Figure 4 As shown, the inner core tube 12 includes a proximal portion extending into the guide wire cavity 11c of the multi-lumen tube 11, and the proximal portion of the inner core tube is sealed to the cavity wall of the guide wire cavity 11c. The bearing inner ring 21 is sleeved and fixed on the outer periphery of the distal end of the multi-lumen tube 11, and the proximal portion of the inner core tube is supported inside the section of the multi-lumen tube 11 in which the bearing inner ring 21 is sleeved. This arrangement allows for a greater contact length between the proximal portion of the inner core tube and the multi-lumen tube 11, which is beneficial for achieving a reliable seal between the inner core tube 12 and the multi-lumen tube 11.

[0031] like Figure 3 and Figure 4 As shown, the proximal end of catheter 1 is connected to catheter hub 6. Catheter hub 6 has an internally hollow structure and is equipped with an anchoring balloon inflation / deflation interface 6a, a notched balloon inflation / deflation interface 6b, and a guidewire port 6c. The anchoring balloon inflation / deflation interface 6a communicates with the proximal end of the anchoring balloon inflation chamber 11a, the notched balloon inflation / deflation interface 6b communicates with the proximal end of the notched balloon inflation chamber 11b, and the guidewire port 6c communicates with the proximal end of the guidewire lumen 11c. In use, the notched balloon 4 at the distal end of the balloon dilation catheter is guided by the guidewire and delivered to the location of the narrowed plaque within the blood vessel.

[0032] The procedure for using this type of balloon dilation catheter in balloon angioplasty is as follows: Before catheter 1 is inserted into the blood vessel, both anchoring balloon 3 and notched balloon 4 are in a depressurized and contracted state.

[0033] When the scoring balloon 4 at the distal end of catheter 1 reaches the location of plaque and calcified lesions on the vessel wall, the scoring balloon 4 is first inflated to put it into an inflated state. The inflated scoring balloon 4 then compresses and scores the plaque on the vessel wall. At this time, the balloon dilates the catheter as follows: Figure 5 and Figure 6 As shown.

[0034] Next, the anchoring balloon 3 is inflated. After inflation and expansion, the anchoring balloon 3 is anchored to the inner wall of the blood vessel. At this time, the balloon dilation catheter is in the following state: Figure 2 and Figure 3 As shown.

[0035] Next, depressurize the notched balloon 4 to bring it to a depressurized state. At this point, the balloon dilation catheter is in the following state: Figure 7 and Figure 8 As shown. In this state, rotating catheter 1 allows adjustment of the deflection angle of the scoring balloon 4 without significant change in its axial position. Then, the scoring balloon 4 is inflated again, allowing it to compress and score plaques at different circumferential locations on the vessel wall.

[0036] Finally, depressurize the notched balloon 4 and the anchoring balloon 3, and the balloon dilation catheter can be removed from the body.

[0037] The balloon dilation catheter provided in this embodiment of the invention has an additional bearing 2 located proximal to the scoring balloon 4 at the distal end of the catheter 1. The inner ring 21 of the bearing is fixed to the outer periphery of the catheter 1, and the outer ring 22 of the bearing is fixed to the anchor balloon 3. Since the outer ring 22 of the bearing can rotate freely in the circumferential direction relative to the inner ring 21 of the bearing, when the anchor balloon 3 is inflated and anchored to the inner wall of the blood vessel, the catheter 1 and the depressurized scoring balloon 4 can rotate relatively in the circumferential direction relative to the anchor balloon 3. At this time, rotating the catheter 1 can adjust the deflection angle of the scoring balloon 4 without significantly changing the axial position of the scoring balloon 4. This allows the scoring element 41 on the outer periphery of the scoring balloon 4 to squeeze and score plaques at different circumferential positions on the inner wall of the blood vessel during multiple scoring processes, thereby greatly improving the dilation effect of the scoring balloon 4 on the symptoms of vascular stenosis during the balloon dilation and angioplasty procedure.

[0038] Obviously, the above embodiments are merely illustrative examples for clear explanation and are not intended to limit the implementation. Those skilled in the art will recognize that other variations or modifications can be made based on the above description. It is neither necessary nor possible to exhaustively list all possible implementations here. However, obvious variations or modifications derived therefrom are still within the scope of protection of this invention.

Claims

1. A balloon dilation catheter, characterized in that, include: Catheter (1); The bearing (2) includes an inner bearing ring (21) fixedly connected to the conduit (1) and an outer bearing ring (22) sleeved and connected to the outer circumference of the inner bearing ring (21) and capable of rotating circumferentially relative to the inner bearing ring (21); An anchoring balloon (3) is connected to the outer ring (22) of the bearing and can expand radially relative to the catheter (1). The anchoring balloon (3) can be anchored in the blood vessel when expanded. A scoring balloon (4) is connected to the catheter (1) and located at the distal end of the anchoring balloon (3). The scoring balloon (4) is radially expandable relative to the catheter (1). When expanded, the scoring balloon (4) can compress and score plaques on the inner wall of the blood vessel.

2. The balloon dilation catheter according to claim 1, characterized in that, The bearing (2) further includes a plurality of balls (23) disposed between the inner ring (21) and the outer ring (22) of the bearing, the plurality of balls (23) causing a gap between the inner ring (21) and the outer ring (22).

3. The balloon dilation catheter according to claim 1, characterized in that, The outer periphery of the scoring balloon (4) is provided with a plurality of scoring elements (41), which are arranged at intervals along the circumference of the scoring balloon (4) and the length direction of the plurality of scoring elements (41) extends along the axial direction of the scoring balloon (4); when the scoring balloon (4) is in an expanded state, the plurality of scoring elements (41) can squeeze and score the plaque on the inner wall of the blood vessel.

4. The balloon dilation catheter according to claim 1, characterized in that, The catheter (1) has an independent anchoring balloon filling chamber (11a) and a notched balloon filling chamber (11b) inside. The notched balloon filling chamber (11b) is connected to the inner lumen of the notched balloon (4). The proximal end of the anchoring balloon (3) is connected to an inflating tube (5). One end of the inflating tube (5) is connected to the anchoring balloon filling chamber (11a), and the other end is connected to the inner lumen of the anchoring balloon (3).

5. The balloon dilation catheter according to claim 4, characterized in that, The filling tube (5) and the conduit (1) are welded and sealed at the contact position, and the filling tube (5) and the anchoring balloon (3) are welded and sealed at the contact position.

6. The balloon dilation catheter according to claim 4, characterized in that, The catheter (1) includes a multi-lumen tube (11), and the interior of the multi-lumen tube (11) is provided with a guidewire lumen (11c) through which a guidewire can pass. The guidewire lumen (11c), the anchoring balloon filling lumen (11a), and the notched balloon filling lumen (11b) are three independent cavities inside the catheter (1).

7. The balloon dilation catheter according to claim 6, characterized in that, The anchoring balloon inflation chamber (11a) and the notched balloon inflation chamber (11b) are located in different regions on the outer periphery of the guidewire chamber (11c).

8. The balloon dilation catheter according to claim 7, characterized in that, The catheter (1) further includes an inner core tube (12) and an outer tube (13) connected to the multi-lumen tube (11); the inner core tube (12) is sealed to the multi-lumen tube (11), and the inner lumen of the inner core tube (12) is connected to the guidewire lumen (11c); the proximal end of the outer tube (13) is sealed to the distal end of the multi-lumen tube (11) and coaxially sleeved on the outer periphery of the inner core tube (12); the cavity between the outer tube (13) and the inner core tube (12) is the distal lumen (14); the punctured balloon (4) is connected to the outer tube (13); the distal end of the multi-lumen tube (11) is provided with an opening connecting the punctured balloon filling chamber (11b) and the distal lumen (14); the distal lumen (14) connects the punctured balloon filling chamber (11b) and the inner lumen of the punctured balloon (4).

9. The balloon dilation catheter according to claim 8, characterized in that, The inner core tube (12) includes a proximal portion of the inner core tube extending into the guide wire cavity (11c) of the multi-cavity tube (11), and the proximal portion of the inner core tube is sealed to the cavity wall of the guide wire cavity (11c); the bearing inner ring (21) is sleeved and fixed on the outer periphery of the distal end of the multi-cavity tube (11), and the proximal portion of the inner core tube is supported inside the tube section of the multi-cavity tube (11) on which the bearing inner ring (21) is sleeved.

10. The balloon dilation catheter according to claim 6, characterized in that, The proximal end of the catheter (1) is connected to a catheter seat (6), which has an internal hollow structure. The catheter seat (6) is provided with an anchoring balloon inflation / deflation port (6a) communicating with the anchoring balloon inflation chamber (11a), a scoring balloon inflation / deflation port (6b) communicating with the scoring balloon inflation chamber (11b), and a guidewire port (6c) communicating with the guidewire chamber (11c).

Images