Scored balloon device

Abstract

The present invention provides a scoring balloon device, which relates to the technical field of medical devices, and comprises a catheter, a balloon, a scoring piece and a scoring piece controller; the balloon is arranged on the catheter; the distal end of the scoring piece is fixed on the catheter, the fixed position is located on the distal end side of the balloon, and the proximal end of the scoring piece is movably arranged; the scoring piece controller is connected to the proximal end of the scoring piece, and the scoring piece controller can drive the scoring piece to be wound around the balloon; the present invention changes the winding form of the scoring piece on the balloon through the scoring piece controller, and can form different forms of scoring on the calcified plaque, which is beneficial to improving the plaque breaking effect, and can also avoid the problem of the scoring piece falling off the balloon during use.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a scored balloon device. Background Art

[0002] Vascular intervention is an important treatment modality for revascularization of vascular stenosis. The angioplasty procedure involves the use of an inflatable balloon to dilate the blocked blood vessel.

[0003] The scored balloon is a special type of balloon with several scored parts arranged axially on the outer circumferential surface of the balloon. When the balloon expands, the scored parts on the balloon surface squeeze the calcified plaques to form cracks, so that the calcified plaques are separated from the blood vessel wall and stop further proliferation, thereby improving the treatment effect of calcified plaques.

[0004] However, the scoring parts on traditional scoring balloons are usually fixed to the balloon surface by secondary molding methods such as physical or chemical adhesives. These fixing methods result in a low bonding strength between the scoring parts and the balloon, and such adhesives are sensitive to ethanol solvents, which may cause the scoring parts to fall off during balloon expansion and contraction. Moreover, all products on the market use directional scoring technology, that is, the scoring parts have a fixed structure and cannot provide more scoring textures, resulting in limited treatment effects on calcified plaques.

[0005] Therefore, it is necessary to design a new type of scored balloon device to solve the above technical problems. Summary of the invention

[0006] The object of the present invention is to provide a scored balloon device to solve the problems existing in the above-mentioned prior art. By changing the winding form of the scoring member on the balloon through the scoring member controller, different forms of scoring can be formed on the calcified plaque, which is beneficial to improve the plaque fragmentation effect. At the same time, it can also avoid the problem of the scoring member falling off the balloon during use.

[0007] To achieve the above object, the present invention provides the following solutions:

[0008] A scoring balloon device comprises a catheter, a balloon, a scoring piece and a scoring piece controller; the balloon is arranged on the catheter; the distal end of the scoring piece is fixed on the catheter, the fixed position is located on the distal end side of the balloon, and the proximal end of the scoring piece is movably arranged; the scoring piece controller is connected to the proximal end of the scoring piece, and the scoring piece controller can drive the scoring piece to be wound around the balloon.

[0009] As an embodiment, the catheter is provided with a notched member connecting block located at the distal end side of the balloon, and the notched member connecting block is fixedly connected to the distal end of the notched member.

[0010] As one embodiment, a limit tube is further provided at the distal end of the catheter, the axis of the limit tube is parallel to the axis of the catheter, the limit tube is located between the notch member connecting block and the balloon, and is arranged close to the balloon, and the notch member penetrates into the limit tube.

[0011] As one embodiment, a distal developing ring is provided on the catheter, and the distal developing ring is provided close to the distal end of the balloon.

[0012] As one embodiment, a proximal developing ring is provided on the catheter, and the proximal developing ring is provided close to the proximal end of the balloon.

[0013] As an embodiment, the proximal developing ring and the distal developing ring are both made of platinum-iridium alloy.

[0014] As an embodiment, the proximal developing ring and the distal developing ring are both fixed to the catheter in the form of forging.

[0015] As one embodiment, the distal end of the catheter is connected to a catheter seat, the notch member controller is disposed on the catheter seat, and the catheter seat is provided with an inflation port and a guide wire port, the inflation port is connected to the balloon and is used to inflate the balloon, and the guide wire port is used to insert a guide wire.

[0016] As an embodiment, the scoring member is a metal wire made of nickel-titanium alloy.

[0017] As an embodiment, it further includes a pull ring fixed at the proximal end of the scoring member.

[0018] Compared with the prior art, the present invention has the following technical effects:

[0019] 1. In the present invention, the scoring member and the balloon are separately arranged, and the winding form of the scoring member on the balloon is changed by the scoring member controller, so that different forms of scoring can be formed on the calcified plaque, which is beneficial to improve the plaque breaking effect;

[0020] 2. In the present invention, the scoring member and the balloon are separately arranged, so there will be no problem of the scoring member falling off during the balloon expansion or contraction process, the scoring process is safer and the service life is longer;

[0021] 3. When the scored balloon device of the present invention is placed in a blood vessel, the scored component may not be wrapped around the catheter or the balloon, and the scored component is located in a straight line on one side of the catheter, so that the scored balloon device has higher passability in the blood vessel. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] In order to more clearly illustrate the embodiments of the present invention or the technical solutions in the prior art, the drawings required for use in the embodiments will be briefly introduced below. Obviously, the drawings described below are only some embodiments of the present invention. For ordinary technicians in this field, other drawings can be obtained based on these drawings without paying creative labor.

[0023] Figure 1 A schematic diagram of the structure of a scored balloon device in one embodiment of the present invention;

[0024] Figure 2 This is a schematic structural diagram of the distal end of a catheter in one embodiment of the present invention;

[0025] Figure 3 This is a schematic structural diagram of a scoring member in one embodiment of the present invention, in which the scoring member is wound on the balloon in a straight line;

[0026] Figure 4 This is a schematic diagram of a structure in which a scoring element is wound on a balloon in an oblique line shape in one embodiment of the present invention;

[0027] Figure 5 This is a schematic diagram of a structure in which a scoring element is wound on a balloon in a spiral shape in one embodiment of the present invention;

[0028] Figure 6 It is a schematic diagram of the working of the scoring member in a narrow blood vessel when the scoring member is wound on the balloon in a spiral shape in one embodiment of the present invention;

[0029] Figure 7 It is a schematic diagram of the working state of the scoring member in a narrow blood vessel when the winding mode of the scoring member on the balloon is linear in one embodiment of the present invention;

[0030] Figure 8 It is a schematic diagram of the unfolding of the scoring on the plaque when the scoring member is wound on the balloon in a straight line in one embodiment of the present invention;

[0031] Fig. 9 It is a schematic diagram of the unfolding of the scoring on the plaque when the scoring member is wound on the balloon in an oblique line shape in one embodiment of the present invention;

[0032] Fig.10 It is a schematic diagram of the unfolding of the scoring on the plaque when the scoring member is wound on the balloon in a spiral shape in one embodiment of the present invention;

[0033] Fig.11 It is a schematic diagram of the unfolding of the scoring on the plaque when the scoring member is wound on the balloon in a straight line, an oblique line and a spiral shape in sequence in one embodiment of the present invention;

[0034] Fig.12A schematic diagram of the structure of a scoring member controller in one embodiment of the present invention;

[0035] Description of reference numerals:

[0036] 1. Catheter; 2. Balloon; 3. Notched part; 4. Notched part controller; 5. Notched part connecting block; 6. Limiting tube; 7. Proximal developing ring; 8. Distal developing ring; 9. Catheter seat; 10. Inflation port; 11. Guide wire port; 12. Pull ring; 13. Mounting hole; 14. Perforation. DETAILED DESCRIPTION

[0037] The following will be combined with the drawings in the embodiments of the present invention to clearly and completely describe the technical solutions in the embodiments of the present invention. Obviously, the described embodiments are only part of the embodiments of the present invention, not all of the embodiments. Based on the embodiments of the present invention, all other embodiments obtained by ordinary technicians in this field without creative work are within the scope of protection of the present invention.

[0038] The object of the present invention is to provide a scored balloon device to solve the problems existing in the above-mentioned prior art. By changing the winding form of the scoring member on the balloon through the scoring member controller, different forms of scoring can be formed on the calcified plaque, which is beneficial to improve the plaque fragmentation effect. At the same time, it can also avoid the problem of the scoring member falling off the balloon during use.

[0039] In order to make the above-mentioned objects, features and advantages of the present invention more obvious and easy to understand, the present invention is further described in detail below with reference to the accompanying drawings and specific embodiments.

[0040] like Figure 1 to Figure 12 As shown, this embodiment provides a scoring balloon device, including a catheter 1, a balloon 2, a scoring member 3 and a scoring member controller 4; the catheter 1 has a channel for a guide wire to pass through; the balloon 2 is arranged on the catheter 1; the distal end of the scoring member 3 is fixed on the catheter 1, and the fixed position is located on the distal side of the balloon 2, and the proximal end of the scoring member 3 is movably arranged so that the scoring member 3 can be wound on the balloon 2 or on both the balloon 2 and the catheter 1. The scoring member controller 4 is connected to the proximal end of the scoring member 3, and the scoring member controller 4 can drive the scoring member 3 to be wound on the balloon 2. The proximal end in this embodiment refers to the end close to the operator, and the distal end refers to the end away from the operator.

[0041] When in use, a guide wire is first inserted into the blood vessel, and then the catheter 1 is inserted into the blood vessel along the guide wire, and the balloon 2 is located at the calcified part of the blood vessel. Then, the scoring member 3 is driven by the scoring member controller 4 to rotate around the catheter 1, so that the scoring member 3 is wrapped around the balloon 2 and the catheter 1. Finally, the balloon 2 is pressurized to expand the balloon 2, as shown in FIG. Figure 6 , Figure 7As shown, during the expansion of the balloon 2, the balloon 2 concentrates the pressure on the scoring member 3. During the squeezing of the inner wall of the blood vessel by the balloon 2, the scoring member 3 can score the calcified plaque, so that the calcified plaque will have cracks, stop proliferation, and even make the calcified plaque fall off the blood vessel wall, thereby improving the therapeutic effect of vascular calcification. After one scoring, the balloon 2 can be decompressed to shrink, and the winding method of the scoring member 3 on the catheter 1 and the balloon 2 can be changed again. For example, the number of windings of the scoring member 3 on the balloon 2 can be changed, or the scoring member 3 is not wound and is arranged in a straight line on one side of the balloon 2. After changing the winding method of the scoring member 3 on the balloon 2 and re-pressurizing the balloon 2, the scoring member 3 will produce new scorings on the calcified plaque, increase the number of scorings on the calcified plaque, and thus improve the plaque fragmentation effect. During use, the surgeon can also wrap the scoring member 3 in a targeted manner according to the shape of the plaque. For example, if the calcified plaque is only gathered on one side of the blood vessel, the scoring member 3 can be wrapped in an oblique line shape (such as Figure 4 as shown) or straight (without winding, as Figure 3 As shown in FIG. 1 ), the plaque is scored using the portion of the balloon 2 wrapped around the scoring member 3 to prevent the scoring member 3 from being spiral (as shown in FIG. 1 ). Figure 5 When the scoring piece 3 is wrapped around the catheter 1 or the balloon 2, the inner wall of the blood vessel is damaged. Moreover, in this embodiment, the scoring piece 3 is separately arranged from the balloon 2, so there will be no problem of the scoring piece 3 falling off during the expansion or contraction of the balloon 2, and the scoring process is safer and the service life is longer. In addition, when the scoring balloon device in this embodiment is placed in a blood vessel, the scoring piece 3 is not wrapped around the catheter 1 or the balloon 2, and the scoring piece 3 is located on one side of the catheter 1 in a straight line, so that the scoring balloon device has higher passability in the blood vessel.

[0042] In this embodiment, the notch member 3 is a metal wire made of nickel-titanium alloy. In this embodiment, the notch member controller 4 is a conventional device, which may include a mounting hole 13 for mounting the notch member controller 4 itself and a through hole 14 for passing the notch member 3, such as Fig.12 As shown, after the scoring member 3 passes through the perforation 14, the proximal end is connected to the pull ring 12. When the scoring member controller 4 drives the scoring member 3 to rotate and wrap around the balloon 2 and the catheter 1, the pull ring 12 can be used to apply a force toward the distal end to the scoring member 3, so that the scoring member 3 can be wrapped around the balloon 2 at a distant position. After the wrapping is completed, the scoring member 3 is tightened by the pull ring 12, so that the scoring member 3 can be tightly attached to the surface of the balloon 2 during the expansion of the balloon 2.

[0043] like Figure 2 As shown, the catheter 1 is provided with a notched member connecting block 5 located at the distal end side of the balloon 2, and the notched member connecting block 5 is fixedly connected to the distal end of the notched member 3, and the connection method can be bonding.

[0044] As an embodiment, a limiting tube 6 is further provided at the distal end of the catheter 1, the axis of the limiting tube 6 is parallel to the axis of the catheter 1, the limiting tube 6 is located between the notched member connecting block 5 and the balloon 2, and is provided close to the balloon 2, and the notched member 3 penetrates into the limiting tube 6. The limiting tube 6 has a small diameter, and its inner diameter can pass through the notched member 3. By providing the limiting tube 6, the notched member 3 can be more closely attached to the balloon 2 and the catheter 1.

[0045] As an embodiment, on the catheter 1, a proximal developing ring 7 and a distal developing ring 8 are respectively arranged on both sides of the balloon 2, the proximal developing ring 7 is arranged close to the proximal end of the balloon 2, and the distal developing ring 8 is arranged close to the distal end of the balloon 2. The proximal developing ring 7 and the distal developing ring 8 are both made of platinum-iridium alloy and are fixed on the catheter 1 in the form of forging. The proximal developing ring 7 and the distal developing ring 8 can be developed under the action of radiation, which is convenient for the operator to identify the position of the proximal end and the distal end of the balloon 2.

[0046] As an implementation mode, in this embodiment, the distal end of the catheter 1 is connected to a catheter seat 9, and the notch member controller 4 is rotatably set on the catheter seat 9 through the mounting hole 13. The catheter seat 9 is provided with an inflation port 10 and a guide wire port 11. The inflation port 10 is connected to the balloon 2 and is used to inflate the balloon 2. The guide wire port 11 is connected to a channel in the catheter 1 for the guide wire to pass through and is used to insert the guide wire.

[0047] Adaptive changes made according to actual needs are all within the protection scope of the present invention.

[0048] The present invention uses specific examples to illustrate the principles and implementation methods of the present invention. The above examples are only used to help understand the method and core ideas of the present invention. At the same time, for those skilled in the art, according to the ideas of the present invention, there will be changes in the specific implementation methods and application scope. In summary, the content of this specification should not be understood as limiting the present invention.

Claims

1. A scored balloon device, characterized in that: include: catheter; a balloon, wherein the balloon is disposed on the catheter; A scoring member, wherein the distal end of the scoring member is fixed on the catheter, the fixing position is located at the distal end side of the balloon, the proximal end of the scoring member is movably arranged, and the scoring member is located outside the catheter and the balloon; and a notch member controller, the notch member controller is connected to the proximal end of the notch member, the distal end of the catheter is connected to a catheter seat, the notch member controller comprises a mounting hole and a through hole for penetrating the notch member, after the notch member passes through the through hole, the proximal end is connected to a pull ring; the notch member controller is rotatably arranged on the catheter seat through the mounting hole; the notch member controller can drive the notch member to be wound around the balloon; A guidewire is first inserted into the blood vessel, and then the catheter is inserted into the blood vessel along the guidewire, and the balloon is located at the calcified part of the blood vessel; the scoring part is then driven by the scoring part controller to rotate around the catheter, so that the scoring part is wound around the balloon and the catheter; finally, the balloon is pressurized to expand the balloon, and during the expansion of the balloon, the balloon concentrates pressure on the scoring part, and the balloon can score the calcified plaque through the scoring part during the squeezing of the inner wall of the blood vessel; after one scoring, the balloon is decompressed to shrink it, and the winding method of the scoring part on the catheter and the balloon is changed again. After the balloon is re-pressurized, the scoring part will produce new scores on the calcified plaque.

2. The scored balloon device according to claim 1, characterized in that: The catheter is provided with a notched member connecting block located at the distal end side of the balloon, and the notched member connecting block is fixedly connected to the distal end of the notched member.

3. The scored balloon device according to claim 2, characterized in that: A limiting tube is also provided at the distal end of the catheter, the axis of which is parallel to the axis of the catheter, the limiting tube is located between the notched member connecting block and the balloon, and is arranged close to the balloon, and the notched member penetrates into the limiting tube.

4. The scored balloon device according to claim 1, characterized in that: The catheter is provided with a distal developing ring, and the distal developing ring is arranged close to the distal end of the balloon.

5. The scored balloon device according to claim 4, characterized in that: The catheter is provided with a proximal developing ring, and the proximal developing ring is arranged close to the proximal end of the balloon.

6. The scored balloon device according to claim 5, characterized in that: The proximal developing ring and the distal developing ring are both made of platinum-iridium alloy.

7. The scored balloon device according to claim 6, characterized in that: The proximal developing ring and the distal developing ring are both fixed on the catheter in the form of forging.

8. The scored balloon device according to claim 1, characterized in that: The catheter seat is provided with an inflation port and a guide wire port. The inflation port is communicated with the balloon and is used for inflating the balloon to expand it, and the guide wire port is used for inserting a guide wire.

9. The scored balloon device according to claim 1, characterized in that: The notching piece is a metal wire made of nickel-titanium alloy.

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