Incision wire and indented balloon catheter

Abstract

The invention provides a indented wire which is made of a high polymer material and has a hollow tubular structure, the indented wire can be axially folded in a natural state, the radial section width of the folded indented wire is 0.18-0.63 mm, and the thickness of the folded indented wire is 0.02-0.1 mm; the indentation wire is sealed from one end so that the indentation wire can form a filling inner cavity, the filling inner cavity is filled with pressure of 20 atm to 50 atm, the indentation wire can be filled until the inner diameter ranges from 0.1 mm to 0.3 mm, and the outer diameter ranges from 0.12 mm to 0.4 mm. The invention further provides a nicking balloon catheter comprising the nicking wire. The nick balloon catheter provided by the invention has a smaller radial size in a conveying process, so that the nick balloon catheter has better trafficability; when the balloon and the nick wire are filled with fluid, a better cutting effect can be generated on a diseased region through the filled nick wire.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and in particular to a scoring wire and a scoring balloon catheter. Background Technology

[0002] Percutaneous coronary intervention (PCI) is an important means of revascularization treatment for coronary heart disease. The number of patients undergoing PCI in my country is increasing year by year. Guiding catheters, cutting balloons, stents and other commonly used medical devices in PCI are one of the important factors that determine the outcome of the procedure.

[0003] In the treatment of vascular stenosis caused by intravascular calcification or plaque, pretreatment of the calcification or plaque is usually required before drug delivery or stent implantation. Using a cutting balloon to cut the lesion is a standard pretreatment method for vascular stenosis. There are various types of cutting balloons, such as blade cutting balloons with a blade structure on the outside and guidewire cutting balloons with a guidewire on the outside. However, due to the sharp structure of the blade, there is a risk of vascular rupture during lesion treatment. While guidewire cutting balloons are safer than blade-structured balloons, the high rigidity of the guidewire can lead to poor balloon flexibility, making it difficult to pass through tortuous lesions and adapt to different degrees of lesion treatment. Summary of the Invention

[0004] Therefore, it is necessary to provide a notched balloon catheter with good permeability and pushability, and the ability to adjust the cutting pressure for different lesion conditions.

[0005] One object of the present invention is to provide a scoring wire made of a polymer material, having a hollow tubular structure. In its natural state, the scoring wire can be folded in half along the axial direction. The radial cross-sectional width of the folded scoring wire is 0.18 to 0.63 mm, and the thickness is 0.02 to 0.1 mm. Closing the scoring wire from one end allows it to form a filled inner cavity. A pressure of 20 to 50 atm is applied to the filled inner cavity. The scoring wire can be filled to an inner diameter range of 0.1 to 0.3 mm and an outer diameter range of 0.12 to 0.4 mm.

[0006] Furthermore, the scoring filament is extruded / blow-molded from at least one of the following materials: nylon, polyethylene, polyurethane, and polyethylene terephthalate.

[0007] Furthermore, the radial cross-section of the filled scribe wire is circular, triangular, or irregular polygonal.

[0008] A second objective of the present invention is to provide a scoring balloon catheter, comprising a catheter assembly, a balloon, and at least one scoring wire as described in any of the preceding claims, wherein the balloon is positioned near the distal end of the catheter assembly, and the distal end of the at least one scoring wire is closed and positioned outside the balloon; during delivery, the scoring wire is folded axially, and the balloon is wrapped around the outside of the scoring wire; after the balloon is inflated, the scoring wire is attached to the outside of the balloon, and a pressure of 20 to 50 atm is applied to the inflation lumen of the scoring wire, and the height of the scoring wire along the radial direction of the balloon is 0.12 to 0.4 mm.

[0009] Furthermore, the number of the scoring wires is 1 to 4, and each scoring wire extends from the distal tube end of the balloon along the outer wall of the balloon to the proximal tube end.

[0010] Furthermore, the catheter assembly includes an outer tube and an inner tube, the inner tube passing through the lumen of the outer tube and its distal end exiting from the distal end of the outer tube, the balloon enclosing the outer tube exiting from the outer tube, and the proximal end of the balloon being sealed to the end wall of the outer tube, a fluid-filling channel for inflating the balloon being formed between the outer tube and the inner tube; the inner tube has a guidewire lumen for inserting a guidewire.

[0011] Furthermore, the scoring balloon catheter also includes at least one filling tube, the number of which corresponds one-to-one with the number of scoring wires. The filling tube is sealed to the proximal opening of the scoring wire, and fluid can be filled into the hollow cavity of the scoring wire through the filling tube.

[0012] Furthermore, the distal end of the scoring wire is fixedly connected to the distal pin of the balloon, and the scoring balloon catheter also includes a fixing element, through which the scoring wire is relatively fixed at the proximal pin of the balloon.

[0013] Furthermore, the fixing member has a ring-shaped structure, a first through hole in the middle, and a plurality of second through holes around the first through hole. The size of the first through hole is adapted to the outer diameter of the outer tube, and the size of the second through holes is adapted to the outer diameter of the scoring wire. By fitting the first through hole and the second through hole of the fixing ring onto the outer tube of the scoring balloon catheter and the outside of the scoring wire, respectively, the scoring wire can be fixed at the proximal end of the balloon.

[0014] Furthermore, the scoring wires on the outside of the balloon have different radial dimensions along the axial direction, with the radial dimension of the middle section of the scoring wires on the outside of the balloon being greater than that of the two ends.

[0015] The scoring balloon catheter provided by this invention, compared with the traditional scoring balloon catheter, has a scoring wire that is folded during delivery, resulting in a smaller radial dimension and better permeability during delivery within blood vessels. After implantation at the lesion site, fluid is filled into the balloon and scoring wire, and the filled scoring wire can produce a better cutting effect on the lesion site. Attached Figure Description

[0016] 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.

[0017] Figure 1 This is a schematic diagram of the structure of the notched balloon catheter in the first embodiment of the present invention.

[0018] Figure 2 for Figure 1 Cross-sectional view along the AA direction.

[0019] Figure 3 This is a schematic diagram of the radial cross-section when the scoring wire is filled in the first embodiment of the present invention.

[0020] Figure 4 This is a schematic diagram of the radial cross-section when the scoring wire is folded along the axial direction in the first embodiment of the present invention.

[0021] Figure 5 This is a schematic diagram of the radial cross-section of the fastener in the first embodiment of the present invention.

[0022] Figure 6 This is a schematic diagram of the radial cross-section of the balloon wrapped with folded scoring wire in the second embodiment of the present invention.

[0023] Figure 7 This is a schematic diagram of the radial cross-section when the scoring wire is filled in the second embodiment of the present invention. Detailed Implementation

[0024] The technical solution of the present invention will be clearly and completely described below with reference to the embodiments. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. 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.

[0025] In this instruction manual, the proximal end refers to the end closer to the operator during the procedure, and the distal end refers to the end further away from the operator during the procedure.

[0026] This invention provides a scoring wire made of a polymer material. The scoring wire has a hollow tubular structure and, in its natural state, exhibits a certain degree of flexibility, allowing it to be folded axially. After folding, the radial cross-sectional width of the scoring wire is 0.18 to 0.63 mm, and the thickness is 0.02 to 0.1 mm. By closing the inner cavity of the scoring wire from one end, a filled inner cavity with an opening at one end can be formed. Filling this filled inner cavity with a pressure of 20 to 50 atm can fill the scoring wire to an inner diameter of 0.1 to 0.3 mm and an outer diameter of 0.12 to 0.4 mm.

[0027] The scoring wire provided by this invention can be placed on the outside of the balloon in a balloon catheter. Compared with traditional blade balloon catheters or guidewire balloon catheters, the scoring wire is in a folded state during delivery and has a smaller radial dimension, which makes the balloon catheter have better passage in blood vessels. When implanted into the lesion site, fluid is filled into the balloon and the scoring wire to produce a better cutting effect on the lesion site.

[0028] In this invention, the scoring filament can be extruded / blow-molded from at least one material selected from nylon, polyethylene, polyurethane, and polyethylene terephthalate. The scoring filament prepared from the materials of this invention, once filled to a preset size, will not undergo structural changes due to pressure variations, thus ensuring a stable structure.

[0029] The present invention also provides a scoring balloon catheter, comprising a catheter assembly, a balloon, and at least one scoring wire. The balloon is positioned near the distal end of the catheter assembly, and the distal end of the at least one scoring wire is closed and positioned outside the balloon. During delivery, the scoring wire is folded axially, and the balloon is wrapped around the scoring wire. When the scoring balloon catheter is implanted into the designated lesion site and the balloon is inflated, the scoring wire adheres to the outer wall of the balloon. Inflating the inner cavity of the scoring wire with a pressure of 20 to 50 atm can make the radial height of the scoring wire along the balloon reach 0.12 to 0.4 mm.

[0030] The scoring balloon catheter provided by this invention, compared with existing conventional scoring balloon catheters made of metal wire, has scoring wires made of polymer materials, which have better flexibility and thus can easily pass through tortuous lesions; the scoring wires can be folded during the delivery of the scoring balloon catheter, thereby effectively reducing the radial size of the balloon catheter in the contracted state, making the scoring balloon catheter easier to pass through narrow calcified lesion areas; when the scoring balloon catheter is implanted into the designated lesion site, the scoring wires can have a better cutting effect by filling the inner lumen of the scoring wires.

[0031] In this invention, the catheter assembly includes an outer tube, an inner tube, and a distal tube. The inner tube passes through the lumen of the outer tube, and its distal end extends from the distal end of the outer tube and passes through the distal tube. A balloon is wrapped around the outer tube located between the distal end of the outer tube and the proximal end of the distal tube, and both ends of the balloon are sealed to the distal end of the outer tube and the proximal end of the distal tube, respectively. The inner tube has a guidewire lumen for inserting a guidewire. An inflation channel is formed between the outer tube and the inner tube, communicating with the lumen of the balloon and used for inflating the balloon. The distal end of the distal tube has a tapered structure.

[0032] During implantation, the device provided by this invention guides the guidewire through the balloon, enabling the scored balloon catheter to have good pushability; fluid is filled into the balloon lumen through the filling channel between the inner and outer tubes, allowing the balloon to inflate from a coiled state to an expanded state, thereby expanding the lesion site; the distal end of the tube is designed with a tapered structure to facilitate the passage of the balloon catheter through narrow lesion sites.

[0033] It should be noted that the scoring wire in this invention can be filled with liquid.

[0034] In this invention, after the scribe wire is filled, its radial cross-sectional shape is circular, arched, triangular, or irregular polygonal.

[0035] Preferably, after the grooving wires are filled, the sidewalls that conform to the outer wall of the balloon have an arcuate structure that matches the outer wall of the balloon.

[0036] It should be noted that the scoring wire extends axially from the distal tube end of the balloon along the outer wall of the balloon to the proximal tube end.

[0037] In this invention, the distal end of the scoring wire can be fixed to the distal end of the balloon by bonding, laser welding or riveting; the scoring wire can be fixed to the proximal end of the balloon by a fastener.

[0038] Preferably, the number of scoring wires is 1 to 4, with multiple scoring wires spaced circumferentially on the outside of the balloon.

[0039] Preferably, the balloon includes a proximal portion, a middle portion, and a distal portion connected sequentially from proximal to distal, wherein the middle portion has the same radial dimension; the proximal portion is connected to the proximal portion of the middle portion and has a radial dimension that gradually decreases towards the proximal end; the distal portion is connected to the distal portion of the middle portion and has a radial dimension that gradually decreases towards the distal end; the scoring wire includes a middle segment, a distal segment connected to the distal end of the middle segment, and a proximal segment connected to the proximal end of the middle segment, wherein the middle segment of the scoring wire is attached to the outer side of the middle portion of the balloon, the distal segment is attached to the outer side of the distal end of the balloon, and the proximal segment is attached to the outer side of the proximal end of the balloon; when the scoring wire is inflated, the middle segment has the same radial dimension, the radial dimension of the distal segment gradually decreases from the middle segment to the distal end, and the radial dimension of the proximal segment gradually decreases from the middle segment to the proximal end.

[0040] In this invention, the notched balloon catheter also includes a fixing element, through which the notched wires can be fixed to the outer tube, thereby achieving fixation at the proximal foot of the balloon.

[0041] Furthermore, the fixation element has a ring-shaped structure with a first fixation hole and multiple second fixation holes extending along the axis. The first fixation hole is located in the middle of the fixation ring and is used to insert the outer tube; the multiple second fixation holes are located radially outside the first fixation hole and are used to insert the scoring wires respectively. This invention achieves relative fixation between the scoring wires and the balloon through the fixation element, thereby preventing the scoring wires from shifting outside the balloon and resulting in a more stable and reliable treatment effect.

[0042] Furthermore, the scoring balloon catheter also includes filling tubes extending axially along the inner or outer wall of the outer tube. The number of filling tubes is the same as the number of scoring wires. Each filling tube is connected to the proximal opening of the scoring wire, and fluid can be filled into the scoring wire through the filling tube.

[0043] It should be noted that the filling tube and the scoring wire can be made of different materials and then sealed together; or they can be integrally formed from the same material, but the shape of the filling tube will not change when the scoring wire is filled with a pressure of 20 to 50 atm.

[0044] The inner diameter of the filling tube is 0.12 to 0.4 mm; the outer diameter is 0.22 to 0.5 mm.

[0045] When there are multiple scoring wires, they can be inflated simultaneously using the same inflation device, or they can be inflated separately using different inflation devices.

[0046] Furthermore, the scored balloon catheter is equipped with a contrast ring, which is located on the inner tube inside the balloon. The contrast ring can serve as a contrast marker for the distal working area during interventional treatment.

[0047] refer to Figures 1 to 4The first embodiment of the present invention provides a notched balloon catheter 100, including an outer tube 110, an inner tube 120, a distal tube 130, a balloon 140, and two notched wires 150. The distal end of the inner tube 120 extends from the distal end of the outer tube 110 and passes through the distal tube 130. The balloon 140 is wrapped around the inner tube 120, and its two ends are sealed to the distal end of the outer tube 110 and the proximal end of the distal tube 130, respectively. A fluid-filling channel is formed between the outer tube 110 and the inner tube 120, communicating with the inner cavity of the balloon 140. Fluid can be filled into the balloon through the fluid-filling channel to inflate the balloon. The inner tube 120 has a through guidewire lumen for inserting a guidewire. The distal end of the distal tube 130 has a tapered structure; both scoring wires 150 are hollow tubular structures, and their distal ends are sealed and fixedly connected to the distal end of the balloon 140. The two scoring wires 150 extend axially from the distal end of the balloon 140 along the outer wall of the balloon 140 to the proximal end, and the two scoring wires 150 are arranged opposite each other along the outer wall of the balloon; the scoring balloon catheter 100 also includes two inflation tubes 160, the distal ends of the two inflation tubes 160 are sealed and connected to the proximal ends of the scoring wires 150, and extend along the outer wall of the outer tube to the proximal end of the scoring balloon catheter 100; fluid can be filled into the inflation lumen of the scoring wires 150 through the proximal end of the inflation tubes 160.

[0048] In this embodiment, after the distal end of the scoring wire 150 is closed, an inflatable lumen 151 is formed. The scoring wire 150 can be folded axially. The scoring balloon catheter 100 provided in this embodiment is in a contracted state before being implanted into the lesion site. At this time, the scoring wire 150 is folded axially to a radial cross-sectional width of 0.18 mm and a thickness of 0.02 mm. The balloon 140 is wound and wrapped around the inner tube 120 and the scoring wire 150. A pressure of 30 atm is injected into the inflatable lumen 151 of the scoring wire 150 through the filling tube 160. The inner diameter of the scoring wire is 0.1 mm and the height along the radial direction of the balloon is 0.2 mm.

[0049] In this embodiment, the inner tube 120 has an axially extending inner lumen with a guidewire inlet 120a and a guidewire outlet 120b. The guidewire inlet 120a is located at the distal end of the inner tube 120 and the distal end tube 130, and the guidewire outlet 120b is located at the proximal end of the balloon 140. The notched balloon catheter provided in this embodiment has good pushability.

[0050] In this embodiment, both the scoring wire 150 and the filling tube 160 are made of nylon material. The scoring wire is blow-molded from nylon material, and the filling tube is extruded from nylon material. The scoring wire 150 has a wall thickness of 0.03 mm and an inner diameter of 0.2 mm. The filling tube 160 has a wall thickness of 0.08 mm and an inner diameter of 0.15 mm.

[0051] refer to Figure 5The scoring balloon catheter 100 provided in this embodiment also includes a fixing member 170. The fixing member 170 has an annular structure, with a first through hole 171 located at the central axis position and a plurality of second through holes 172 located around the first through hole. The outer tube 110 passes through the first through hole, and the scoring wire 150 passes through the second through holes 172, thereby achieving relative fixation between the scoring wire 150 and the balloon.

[0052] The scoring balloon catheter 100 also includes an inflation device 180, the proximal ends of two inflation tubes 160 are connected to the inflation device 180, and the two scoring wires 150 can be inflated simultaneously through the inflation device 180.

[0053] The notched balloon catheter 100 also includes two radiopaque rings 190, both of which are fitted onto the inner tube 120 inside the balloon 140.

[0054] In this embodiment, the radial cross-section of the scribe wire 150 after being filled is annular.

[0055] refer to Figure 6 , Figure 7 The second embodiment of the present invention provides another scoring balloon catheter, which differs from the first embodiment in that there are three scoring wires 250 and three inflatable tubes, arranged circumferentially at 120-degree intervals outside the balloon. When the scoring balloon catheter is in the contracted state, the balloon 240 is wrapped around the inner tube and the three folded scoring wires 250. In this embodiment, the sidewall 251 of the scoring wire in contact with the balloon has an arc-shaped structure adapted to the balloon. This design makes the structure between the scoring wire and the balloon more stable.

[0056] The above embodiments are only used to illustrate the technical solutions of the present invention, and are not intended to limit it. Although the present invention has been described in detail with reference to the foregoing embodiments, those skilled in the art should understand that modifications can still be made to the technical solutions described in the foregoing embodiments, or equivalent substitutions can be made to some or all of the technical features therein. Such modifications or substitutions do not cause the essence of the corresponding technical solutions to deviate from the scope of the technical solutions of the embodiments of the present invention.

Claims

1. A scoring filament, made of a polymer material, characterized in that, It has a hollow tubular structure. In its natural state, the scoring wire can be folded in half along the axial direction. The cross-sectional width of the scored wire after folding is 0.18 to 0.63 mm and the thickness is 0.02 to 0.1 mm. Closing the scoring wire from one end can make the scoring wire form a filled inner cavity. The scoring wire can be filled with a pressure of 20 to 50 atm to fill the filled inner cavity. The scoring wire can be filled to an inner diameter range of 0.1 to 0.3 mm and an outer diameter range of 0.12 to 0.4 mm.

2. The scoring wire according to claim 1, characterized in that, The scoring filament is extruded / blow-molded from at least one of the following materials: nylon, polyethylene, polyurethane, and polyethylene terephthalate.

3. The scoring wire according to claim 1, characterized in that, The radial cross-section of the etched wire after it is filled is circular, triangular, or irregular polygonal.

4. A notched balloon catheter, characterized in that, The device includes a catheter assembly, a balloon, and at least one scoring wire as described in any one of claims 1 to 3. The balloon is positioned near the distal end of the catheter assembly, and the distal end of the at least one scoring wire is closed and positioned outside the balloon. During delivery, the scoring wire is folded axially and wrapped inside the balloon. After the balloon is inflated, the scoring wire is attached to the outside of the balloon, and the inner cavity of the scoring wire is inflated with a pressure of 20 to 50 atm. The radial height of the scoring wire along the balloon is 0.12 to 0.4 mm.

5. The notched balloon catheter according to claim 4, characterized in that, The number of the scoring wires is 1 to 4, and each scoring wire extends from the distal tube end of the balloon along the outer wall of the balloon to the proximal tube end.

6. The notched balloon catheter according to claim 4, characterized in that, The catheter assembly includes an outer tube and an inner tube. The inner tube passes through the lumen of the outer tube and its distal end extends from the distal end of the outer tube. The balloon surrounds the outside of the inner tube, and the proximal end of the balloon is sealed to the end wall of the outer tube. An inflation channel for inflating the balloon is formed between the outer tube and the inner tube. The inner tube has a guidewire lumen for inserting a guidewire.

7. The notched balloon catheter according to claim 4, characterized in that, The scoring balloon catheter also includes at least one filling tube, the number of which corresponds one-to-one with the number of scoring wires. The filling tube is sealed to the proximal opening of the scoring wire, and fluid can be filled into the hollow cavity of the scoring wire through the filling tube.

8. The notched balloon catheter according to claim 4, characterized in that, The distal end of the scoring wire is fixedly connected to the distal pin of the balloon. The scoring balloon catheter also includes a fixing element, through which the scoring wire is relatively fixed at the proximal pin of the balloon.

9. The notched balloon catheter according to claim 8, characterized in that, The fixing member has a ring-shaped structure, a first through hole in the middle, and a plurality of second through holes around the first through hole. The size of the first through hole is adapted to the outer diameter of the outer tube, and the size of the second through holes is adapted to the outer diameter of the scoring wire. By fitting the first through hole and the second through hole of the fixing ring onto the outer tube of the scoring balloon catheter and the outside of the scoring wire, the scoring wire can be fixed at the proximal end of the balloon.

10. The notched balloon catheter according to claim 4, characterized in that, The scoring wires on the outside of the balloon have different radial dimensions along the axial direction, and the radial dimension of the middle section of the scoring wires on the outside of the balloon is greater than that of the two ends.

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