CN216570109U

CN216570109U - Silk knife and balloon device

Info

Publication number: CN216570109U
Application number: CN202123005524.4U
Authority: CN
Inventors: 古湖南; 季方秋; 王成
Original assignee: Shanghai Lanfan Boyuan Medical Technology Co ltd
Current assignee: Shanghai Lanfan Boyuan Medical Technology Co ltd
Priority date: 2021-12-02
Filing date: 2021-12-02
Publication date: 2022-05-24
Anticipated expiration: 2031-12-02

Abstract

The present disclosure provides a silk knife comprising more than 2 scoring wires, 2 end pieces and more than 2 connecting rods. More than 2 scoring wires are spirally wound to form a spiral structure. 2 end parts set up respectively at helical structure's both ends, and the end part includes the loop configuration, and the loop configuration includes a plurality of end to end's U-shaped pole. Connecting rods more than 2, 1 nick silk and 1U-shaped pole are connected respectively to the both ends of every connecting rod, and the axial extension of helical structure is followed and is parallel to each other to connecting rods more than 2. The disclosure also provides a balloon device, which comprises the above silk knife, the balloon and the outer tube. The balloon has an expanded state and a deflated state. The proximal end of the balloon is connected to the distal end of the outer tube. The far end of the silk knife is fixedly connected with the far end of the balloon, the scoring wire is spirally wound on the outer surface of the balloon along the axial direction of the balloon, and the cross section of the scoring wire is provided with at least one sharp angle in the radial outward direction of the spiral structure.

Description

Silk knife and balloon device

Technical Field

The present disclosure relates to balloons, and more particularly to a silk knife and balloon device.

Background

Coronary artery stenosis refers to a pathological change of thickening and hardening of the coronary artery wall, narrowing of the blood vessel cavity and even occlusion caused by lipid deposition, smooth muscle cell proliferation and collagen fiber increase in the coronary artery intima, and is also called coronary heart disease. When coronary heart disease develops to a certain degree, coronary artery stenosis gradually worsens, blood flow flowing into cardiac muscle is limited, and the heart cannot obtain enough oxygen supply, so that symptoms such as chest discomfort and the like can occur. With the increasing incidence of coronary heart disease and the development of Percutaneous Coronary Intervention (PCI) technology, the amount of PCI surgery in China has increased rapidly in recent years. Drug Eluting Stents (DES) are still the mainstay of angioplasty today. Drug-coated balloons (DCB) have been proven in clinical trials to be effective and safe and effective in-stent restenosis (ISR), coronary stenotic lesions, small vessel lesions, bifurcation lesions, etc., as a new, mature interventional therapy technique.

However, pretreatment is particularly important in both drug-coated balloon (DCB) therapy alone and drug-eluting stent (DES) therapy. The expansion of the common balloon causes the compression and rupture of plaque and the elastic expansion of blood vessels, the intimal laceration and even acute occlusion are easy to occur, and the elastic retraction and the proliferative response to injury which occur later are also important causes of the restenosis of the blood vessels.

SUMMERY OF THE UTILITY MODEL

The present disclosure provides a silk knife and a balloon device, which for example improve the trafficability characteristic and the compliance of the balloon device, and avoid the balloon device from scratching the inner wall of a normal blood vessel during the transportation process.

The present disclosure provides a silk knife, comprising more than 2 indented wires, 2 end pieces and more than 2 connecting rods. More than 2 scoring wires are spirally wound to form a spiral structure. 2 end pieces set up respectively at helical structure's both ends, and the end piece includes the loop configuration, and the loop configuration includes a plurality of end to end's U-shaped pole. Connecting rods more than 2, 1 nick silk and 1U-shaped pole are connected respectively to the both ends of every connecting rod, and the axial extension of helical structure is followed and is parallel to each other to connecting rods more than 2.

According to an embodiment of the present disclosure, a connecting rod is provided between the end pieces at both ends of the wire cutter and the score wire. The connecting rod is linear, and the connecting rod can elastically deform along with the expansion of the saccule in the expansion process of the nick wire. Therefore, the radial expansion diameter of the scored wire can be increased, the situation that the balloon cannot be completely opened due to the fact that one end of the balloon is locked in a spiral mode can be prevented, the constraint force of the scored wire to the balloon can be reduced, and the risk of damaging the balloon can be reduced; simultaneously, the linear type connecting rod has axial effort to middle spiral nick silk, can prevent that spiral nick silk both ends from shifting the dislocation at sacculus expansion in-process, leads to nick silk uneven distribution to appear nick silk even and lock the condition that the sacculus can not be opened to can ensure that the nick silk expands along with the sacculus inflation is even.

In one embodiment, the diameter of the ring structure is smaller than the diameter of the helix structure. Therefore, the end piece can be more firmly fixed at the near end of the balloon and the far end of the elastic tube, and the overall outer diameter of the balloon device can be smaller while the cutting and expanding amplitude of the notch wire is ensured, so that the passing performance and the flexibility of a product are improved.

In one embodiment, the cross-section of the U-shaped bar and/or the connecting bar is rectangular-like and the cross-sectional area of the connecting bar is smaller than the cross-sectional area of the U-shaped bar. Since the cross-sectional area of the connecting rod is smaller than the cross-sectional area of the U-shaped rod, the rigidity of the U-shaped rod is greater than that of the connecting rod. This has guaranteed on the one hand that the U-shaped pole can maintain the whole cyclic annular shape of the nick silk of silk sword in the inflation process of sacculus, improves the overall stability of structure, and on the other hand still is favorable to the elastic deformation of connecting rod, is favorable to increasing the radial inflation diameter of nick silk and prevents that the spiral pins the condition that sacculus one end leads to can not open completely and appears.

In one embodiment, the cross-section of the scored wire is rectangular-like or triangular-like.

In one embodiment, the cross-section of the scored line is isosceles-like or equilateral-like. The scored line with the triangular-like cross section has good stability and sharp corners, can provide higher cutting force under the same balloon expansion pressure, and can cut the plaque more easily to finish treatment.

In one embodiment, more than 2 scored wires are uniformly distributed along the circumference and arranged in a mutually parallel manner and spirally wound in the same direction.

The present disclosure also provides a balloon apparatus comprising the wirecutter, the balloon, and the outer tube of any of the above embodiments. The balloon has an expanded state and a contracted state. The proximal end of the balloon is connected to the distal end of the outer tube. The far end of the silk knife is fixedly connected with the far end of the balloon, the scoring wire is spirally wound on the outer surface of the balloon along the axial direction of the balloon, and the cross section of the scoring wire is provided with at least one sharp angle in the radial outward direction of the spiral structure.

In one embodiment, the balloon apparatus further comprises an elastic tube disposed on an outer surface of the distal end of the outer tube, the distal end of the elastic tube being connected to the proximal end of the wire cutter.

In one embodiment, the side of the connecting rod and/or the score wire near the outer surface of the balloon is a curved surface, and the curved surface is matched with the shape of the outer surface of the balloon. Thus, when the wire cutter is arranged on the surface of the balloon, the wire cutter can be better attached to the surface of the balloon, and meanwhile, the damage of each part, particularly the scoring wire with sharp corners, to the balloon is reduced.

In one embodiment, each scored wire has a winding length in the circumferential direction of more than one circumference.

In one embodiment, when the saccule is in a contraction state, more than 2 grooves are spirally arranged on the outer surface of the saccule, the depth of each groove is equal to or greater than the radial height of the score line, and each score line is embedded in 1 groove; when the balloon is in an expanded state, the outer surface of the balloon extends so that the sharp corners of the scoring wires protrude outward from the outer surface of the balloon.

According to the embodiment of the disclosure, the scoring wire is spirally wound on the outer surface of the balloon along the axial direction of the balloon and is embedded in the groove of the balloon. The score wire is spirally wound to form a helix, the overall diameter of which can be adjusted as the helix is unwound and tightened. In the conveying process of the sacculus, the sacculus is in a contraction state, so that the outer diameter of the nicking wire is at least hidden or shielded by the page flaps of the sacculus on the two sides of the groove, the nicking wire with a sharp angle can not directly contact the inner wall of the blood vessel, and the situation that the nicking wire scratches the blood vessel in the conveying process of the sacculus to cause complications is avoided. And when the saccule reaches the lesion part, the scoring wire can expand the outer diameter of the saccule along with the expansion of the saccule and is exposed out of the groove of the saccule, so that the scoring wire directly contacts the lesion part of the blood vessel and the cutting efficiency of the wire knife is ensured. Therefore, according to the technical scheme of the disclosure, the safety factor of the balloon device can be obviously improved, and the risk is reduced.

Drawings

To more clearly illustrate the technical solutions of the embodiments of the present disclosure, the drawings of the embodiments will be briefly introduced below, and it is apparent that the drawings in the following description relate only to some embodiments of the present disclosure and are not limiting to the present disclosure.

Fig. 1 is a perspective view of a balloon device according to one embodiment of the present disclosure.

Fig. 2A is a cross-sectional view of the balloon apparatus of fig. 1, showing the balloon in a deflated state.

Fig. 2B is a cross-sectional view of the balloon apparatus of fig. 1, showing the balloon in an expanded state.

Fig. 3A-3D are cross-sectional schematic views of a method of using a balloon device according to one embodiment of the present disclosure.

Fig. 4 is a schematic structural view of a wire cutter according to one embodiment of the present disclosure.

Detailed Description

The technical solutions in the embodiments of the present disclosure will be clearly and completely described below with reference to the drawings in the embodiments of the present disclosure, and it is obvious that the described embodiments are only a part of the embodiments of the present disclosure, and not all of the embodiments. All other embodiments, which can be derived by a person skilled in the art from the embodiments disclosed herein without making any creative effort, shall fall within the protection scope of the present disclosure.

Unless otherwise defined, all terms (including technical and scientific terms) used in the embodiments of the present disclosure have the same meaning as commonly understood by one of ordinary skill in the art to which this disclosure belongs. It will be further understood that terms, such as those defined in commonly used dictionaries, should be interpreted as having a meaning that is consistent with their meaning in the context of the relevant art and will not be interpreted in an idealized or overly formal sense unless expressly so defined herein.

The use of "first," "second," and similar terms in the embodiments of the disclosure is not intended to indicate any order, quantity, or importance, but rather to distinguish one element from another. The use of the terms "a" and "an" or "the" and similar referents do not denote a limitation of quantity, but rather denote the presence of at least one. Likewise, the word "comprising" or "comprises", and the like, means that the element or item listed before the word covers the element or item listed after the word and its equivalents, but does not exclude other elements or items. The terms "connected" or "coupled" and the like are not restricted to physical or mechanical connections, but may include electrical or communication connections, whether direct or indirect.

The "distal end" and "proximal end" as defined in this disclosure are described below. The balloon device penetrates through the human skin and then enters the blood vessel of the human body, and enters the diseased region along the direction of the blood vessel of the human body. The entrance where the human skin is inserted is used as a reference point, and along the advancing direction of the saccule, one end far away from the reference point is a far end, and one end close to the reference point is a near end.

At present, when the expansion balloon used for common vascular stenosis is expanded, plaque compression, rupture and vascular elastic expansion are caused, intimal tear and even acute occlusion are easy to occur, and then elastic retraction and proliferative response to injury and other adverse reactions of vascular restenosis and the like also occur.

The inventors of the present disclosure have found that, in some prior art solutions, a cutting balloon catheter is disclosed. The cutting balloon catheter includes a catheter shaft and an inflatable balloon secured to a distal portion of the catheter shaft. One or more cutting blades are secured to the inflatable balloon. Because the cutting blades are fixed on the balloon, the balloon is hard and has a larger outer diameter, so that the passing performance of the balloon is poor, and the capability of the balloon to enter a bent blood vessel or a smaller blood vessel is limited. In addition, cutting blades are more prone to vascular injury during retraction, causing surgical complications, leading to risks and possible life hazards.

The inventor of the present disclosure also finds that, in other prior art solutions, a metal mesh is coated on the surface of the balloon, although the metal mesh is directly coated on the surface of the balloon, the metal mesh and the balloon can be relatively attached together in a linear blood vessel without falling off, when the blood vessel is bent too much, the inner wall of the blood vessel is easily scratched because the cutting unit metal wire is exposed on the outer surface, and the inner wall of a normal blood vessel is easily scratched, which brings a new risk.

Therefore, the inventors of the present disclosure found that the balloon devices in the above prior art have various disadvantages, and have many limitations in clinical application. Thus, the balloon device provided by the embodiments of the present disclosure solves some of the technical problems described above to some extent.

Embodiments of the present disclosure and examples thereof are described in detail below with reference to the accompanying drawings.

Fig. 1 is a schematic perspective view of a balloon device according to one embodiment of the present disclosure, and fig. 2A and 2B are cross-sectional views of the balloon in a deflated state and an inflated state, respectively.

As shown in fig. 1, the balloon device includes a wire cutter 130, a balloon 120, an outer tube 110, and an elastic tube 140. The balloon 120 has an expanded state and a contracted state. The proximal end of the balloon 120 is connected to the distal end of the outer tube 110, and the distal end of the balloon 120 is fixedly connected to the distal end of the wire cutter 110. The elastic tube 140 is disposed on the outer surface of the distal end of the outer tube 110, and the distal end of the elastic tube 140 is connected to the proximal end of the wire cutter 130. When the balloon 120 and the silk knife 130 are expanded, the silk knife 130 can be expanded by the aid of the elastic function of the elastic tube 140, so that the compression on the balloon 120 is reduced, and the catheter can return to a pre-expansion state after pressure relief, and is favorable for withdrawing the catheter from a blood vessel.

In one embodiment, the balloon 120 may be made of nylon (PA) or polyether block amide (PEBAX) or polyester based polymer materials. The outer diameter of the balloon 120 can be adjusted accordingly as desired, and the present disclosure is not limited thereto and may be contingent upon practice. For example, the outer diameter of the balloon 120 may be preferably 1 to 30mm, more preferably 2 to 20mm, still more preferably 2 to 10mm, and most preferably 3 to 8 mm. The length of the balloon 120 can be adjusted accordingly, which is not limited in the present disclosure, and the length of the balloon 120 can be preferably 5-180 mm, more preferably 10-150 mm, and still more preferably 20-100 mm, depending on the actual situation.

Referring to fig. 1, a silk knife 130 according to one embodiment of the present disclosure includes more than 2 scored wires 132. Each score wire 132 is spirally wound to form a spiral structure, and specifically, each score wire 132 is spirally wound on the outer surface of the balloon 120 in the axial direction of the balloon 120. In one embodiment, more than 2 scored wires 132 are evenly distributed along the circumference and arranged in a parallel manner and spirally wound in the same direction. Each score line 132 may be equally spaced along the circumference of the helical structure. For example, in the embodiment shown in fig. 1, the wire cutter 130 includes three scored wires 132, each scored wire 132 being arranged trisected along the circumferential direction of the overall helical structure. The cross-section of score line 132 has at least one sharp angle in the radially outward direction of the helix. The number of sharp corners is practical and the present disclosure is not limited thereto and in one embodiment the number of sharp corners is 1. This pointed design of scoring wire 132 facilitates cutting of the vascular lesion by wire knife 130 upon expansion of balloon 120. Score wire 132 may be made of a memory alloy, for example.

In one embodiment, the side of score wire 132 adjacent the outer surface of balloon 120 is curved, which conforms to the shape of the outer surface of balloon 120. The curved surface design can make the scored line 132 better fit the balloon 120, thereby being more beneficial to uncoiling and tightening the scored line 132 when the balloon 120 is expanded or contracted, and reducing the damage of the scored line 132 with a sharp angle to the balloon 120.

In one embodiment, the number of the score lines 132 may be plural, which is not limited in the present disclosure, and is preferably 1 to 10, more preferably 3 to 8, and still more preferably 3 to 5, depending on the actual situation. Adjacent score lines 132 are not in contact with each other and are arranged equidistantly in the circumferential direction of the spiral structure. Such a design can improve the cutting efficiency of the balloon device on the vascular lesion, and ensure the structural stability of the silk knife 130 and the safe operation of each scoring wire 132.

In one embodiment, the cross-section of the score line 132 is polygonal-like, including rectangular-like, triangular-like. The cross section of the score line 132 is preferably isosceles-like or equilateral-like triangle, as shown in fig. 2A, one side of the score line 132 close to the outer surface of the balloon 120 is a curved surface, the curved surface is adapted to the shape of the outer surface of the balloon 120, and the equilateral triangle is designed in such a way that three sharp corners of the triangle are rounded off. The score line 132, which has a triangular-like cross-section, can cut into the plaque quickly to prevent migration or slippage, ensuring that the expanded position is accurate. Compared with other shape structures, the triangular structure has better stability, and can provide higher cutting force under the same balloon expansion pressure because of sharp-angled stress concentration, so that plaques are cut more easily, and the treatment is completed. In another embodiment, the cross section of the scored line 132 may be a polygon, which is not limited by the present disclosure, and may be determined according to the actual situation, for example, the polygon is preferably a polygon with 3-10 sides, more preferably a polygon with 3-8 sides, and most preferably a polygon with 3-5 sides. The cross section is trapezoidal, so that the cutting width can be improved; the cross section is pentagonal, so that the cutting width can be increased; the hexagonal cross-section increases the cutting speed of score wire 132. Therefore, different cross-sectional shapes of the score line 132 can be selected according to the surgical needs to obtain the corresponding surgical effect.

In one embodiment, each scored wire 132 may be wrapped circumferentially for more than one circumference. In a preferred embodiment, the circumferential length of each scored wire is more than one circumference when the balloon is in the expanded state. According to the balloon device disclosed by the invention, when the balloon is in an expanded state, the single scored wire is wound on the outer surface of the balloon in the circumferential direction for at least one week, so that the cutting effect is ensured to meet the expected requirement.

When the balloon 120 is in a contracted state, more than 2 grooves 122 are spirally arranged on the outer surface of the balloon 120, the depth of each groove 122 is equal to or greater than the radial height of the score line 132, and each score line 132 is embedded in 1 groove 122. In an embodiment of the present disclosure, the surface of balloon 120 is evenly divided into a plurality of leaflet-shaped balloon regions, referred to as leaflets 124. Grooves 122 are formed between lobes 124 such that score wires 132 disposed on the surface of balloon 120 are embedded in grooves 122. The number of the grooves 122 corresponds to the number of the score lines 132, so that the number of the grooves is preferably 1 to 10, more preferably 3 to 8, and still more preferably 3 to 5. When balloon 120 is in the expanded state, the outer surface of balloon 120 is stretched such that the sharp corners of score wires 132 are convex to the outer surface of balloon 120.

As shown in fig. 1 and 2A, when balloon 120 is in the deflated state, scoring wires 132 are embedded in grooves 122, and completely wrapped by lobes 124 without being exposed to the outside. However, embodiments of the present disclosure are not limited thereto, and score wire 132 may also be partially embedded in groove 122, i.e., score wire 132 may still be visible from the surface of balloon device 120. The depth of groove 122 is equal to or greater than the radial height of score wire 132 when balloon 120 is in the deflated state. That is, the sharp corners of each score wire 132 do not protrude from the outer surface of balloon 120 due to the obstruction and blockage by lobes 124. During delivery of the balloon device, the balloon 120 is in a deflated state. Therefore, in the embodiment of the present disclosure, the sharp angle of the score line 132 is at least covered or shielded by the leaves 124 of the balloon 120 on both sides of the groove 122, so that the score line 132 with the sharp angle does not directly contact the inner wall of the blood vessel, thereby avoiding the score line 132 from scratching the blood vessel during the delivery process of the balloon 120 and causing complications.

As shown in fig. 2B, when the balloon 120 is in the expanded state, as the volume of the balloon 120 expands, the leaves 124 of the surface expand, and the outer surface of the balloon 120 expands such that the sharp corners of the score lines 132 protrude beyond the outer surface of the balloon 120. Fig. 2B shows the bladder 120 with the leaves 124 fully expanded so that the score wires 132 are entirely convex to the outer surface of the bladder 120. While embodiments of the present disclosure are not so limited, the lobes 124 of the balloon 120 may also be partially open such that the sharp corners of the score wires 132 protrude from the surface of the balloon 120. In other words, when balloon 120 is in the expanded state, the diameter of the helical structure of score wire 132 exceeds the diameter of the outer surface of balloon 120, i.e., the sharp corners of score wire 132 protrude beyond the outer surface of balloon 120. The balloon 120 is in an expanded state when the balloon device is delivered to the lesion and begins to operate. Therefore, the score line 132 expands the outer diameter thereof with the expansion of the balloon 120 and is exposed from the groove 122 of the balloon 120, so that the score line can directly contact and cut the lesion site of the blood vessel, and the surgical cutting efficiency of the silk knife 130 is fully ensured.

Methods of using balloon devices according to embodiments of the present disclosure are further described below with reference to fig. 3A-3D.

As shown in fig. 3A, during the delivery of the balloon device, the balloon 120 is in a contracted state, the diameter of the spiral structure of the score wire 132 does not exceed the diameter of the outer surface of the balloon 120, and the score wire 132 is embedded in the groove 122. Therefore, the sharp corners of score line 132 are hidden or shielded by at least the lobes 124 of balloon 120 on both sides of groove 122, so that score line 132 with sharp corners does not directly contact the inner wall of the blood vessel, thereby avoiding the score line 132 from scratching the blood vessel during the delivery of the balloon device and causing complications.

As shown in fig. 3B and 3C, as the balloon device is delivered to the lesion, the balloon 120 is gradually expanded, and thus the petals 124 on its surface are gradually opened. The score wire 132 in the groove 122 between the leaves is then gradually pushed out by the inflated balloon, the diameter of the helix also gradually expands as the helical shape of the score wire unwinds, and the outer surface of the balloon 120 stretches so that the sharp corners of the score wire 132 are convex to the outer surface of the balloon 120. So that the score line 132 directly contacts the lesion site of the blood vessel, ensuring the cutting efficiency of the silk knife 130. The cutting depth of score wire 132 on the surface of balloon 120 can be adjusted by fine adjustment of the degree of expansion of balloon 120 during use of the balloon apparatus.

When the balloon device is complete for use, balloon 120 is deflated, as shown in fig. 3D. Depending on the material properties of the memory alloy of scoring wire 132, scoring wire 132 again tightens the helix, with the diameter of the helix decreasing as balloon 120 contracts, causing scoring wire 132 to again re-inlay within groove 122. In this state, the sharp corners of score wire 132 are again hidden or obscured by lobes 124 of balloon 120 on either side of groove 122. In this state, during the withdrawal delivery process of the balloon device, the sharp corners of the score line 132 are shielded and do not directly contact the inner wall of the blood vessel, thereby avoiding the score line 132 scratching the blood vessel during the withdrawal delivery process to cause complications.

According to embodiments of the present disclosure, the bonding force between score wire 132 and balloon 120 is increased by: firstly, uniformly dividing a balloon into 3 leaf-shaped balloon areas (hereinafter referred to as 'leaves') under a vacuum condition by flap equipment, then winding and pressing the 3 leaves to form a similar cylinder, forming a groove area between the adjacent balloon areas, then sleeving a processed silk knife on the surface of the balloon, filling pressure into a catheter by the silk knife and the balloon through the pressing and holding equipment in the later process, and extruding the balloon leaves into gaps of the silk knife through the pressure; then, the bound outer diameter is reduced continuously, and the balloon flap which protrudes out of the silk knife is flattened to cover the score line in the silk knife, so that the score line is embedded in the groove of the balloon, and the outer diameter of the tubular shape of the score line does not exceed the outer diameter of the surface of the balloon.

In conclusion, according to the balloon device disclosed by the embodiment of the disclosure, the score wires are spirally wound on the outer surface of the balloon along the axial direction of the balloon, so that the overall flexibility of the balloon device provided with the silk knife is improved, the score wires of the silk knife are shielded in the balloon conveying process, the flexibility and the trafficability of the balloon device are further improved, and the inner wall of a normal blood vessel is prevented from being scratched by the balloon device in the conveying process. Moreover, the cutting efficiency of the score line on the surface of the balloon is improved through the expansion and expansion effects of the balloon. Therefore, the balloon device of the embodiment of the disclosure obviously improves the safety factor of the balloon device and reduces the operation risk.

The wire cutter 130 according to an embodiment of the present disclosure will be described in more detail below with reference to fig. 1 and 4. As shown in fig. 1 and 4, the silk knife 130 includes more than 2 scoring wires 132. Score wire 132 is helically wound to form a helical structure. The wire cutter 130 further includes 2 end pieces 134 disposed at either end of the helix, and the end piece 314 includes a ring structure comprising a plurality of U-shaped rods connected end to end. The number of U-shaped rods at either end of end piece 134 corresponds to the number of score wires 132. In fig. 4, the number of U-shaped bars and score wires 132 at either end of the end piece 134 is three. The present disclosure is not so limited and the number of U-shaped bars and score wires 132 at either end of the end piece 134 may be adjusted as desired. The number of the U-shaped rods at any end of the end piece 134 is preferably 1-10, more preferably 3-8, and still more preferably 3-5. The U-shaped rods at either end of end piece 134 may allow end piece 134 to fit tightly over the balloon device, helping to maintain the overall helical configuration of scoring wires 132 in wire cutter 130 in the delivery and operational state, and allowing wire cutter 130 to more securely connect to the distal ends of elastomeric tube 140 and balloon 120. The material of the elastic tube 140 is an elastomer polymer, including silicone rubber, nylon elastomer, and polyurethane. When the balloon 120 is expanded, the silk knifes 130 can radially expand and axially shrink along with the expansion of the balloon 120, and meanwhile, the elastic tubes 140 are axially stretched, so that the expansion of the silk knifes 130 can be assisted by the elastic function of the elastic tubes 140, and the connection between the silk knifes 130 and the catheter is ensured not to be broken or separated; when the balloon 120 is expanded and returns to the compressed state, the silk knife 130 returns to the initial state by virtue of the memory function and the elastic function of the elastic tube 140, so that the catheter can be withdrawn from the blood vessel.

In one embodiment, the diameter of the ring-like structure of end piece 134 is smaller than the diameter of the helical structure of score wire 132. Thus, the end piece 134 can ensure the cutting expansion amplitude of the scoring wire 132, and simultaneously, the overall outer diameter of the balloon device is smaller, and the passing performance and the flexibility of the product are improved.

The silk knife 130 also comprises more than 2 connecting rods 136. The two ends of each connecting rod 136 are respectively connected with 1 scoring wire and 1U-shaped rod, more than 2 connecting rods extend along the axial direction of the spiral structure and are parallel to each other, so that each scoring wire 132 is connected with the U-shaped rod at any end of the end piece 134. The number of tie bars 136 at either end of score line 132 corresponds to the number of score lines 132. For example, the number of the connecting rods 136 at any end of the scoring wire 132 is preferably 1 to 10, more preferably 3 to 8, and still more preferably 3 to 5. The number of connecting rods 136 is not limited by the present disclosure and may be determined as the case may be. According to an embodiment of the present disclosure, the connecting rod 136 may be elastically deformed during the uncoiling expansion of the score wire 132 as the balloon 120 is inflated. Thus, the radial expansion diameter of the scored line 132 can be increased, the situation that the balloon 120 cannot be completely opened due to the fact that one end of the balloon 120 is locked by the screw can be prevented, the constraint force of the scored line 132 on the balloon 120 can be reduced, and the risk of damaging the balloon 120 can be reduced.

In one embodiment, the cross-section of the U-shaped bar and/or the connecting bar 136 is rectangular-like, with the four corners of the rectangular-like being rounded. The cross-sectional area of the connecting rod 136 is less than the cross-sectional area of the U-shaped rod. The substantially rectangular cross-section of the U-shaped bar and/or the connecting bar 136 may improve the support of the end piece 134 and the connecting bar 136. Since the cross-sectional area of the connecting rod 136 is smaller than the cross-sectional area of the U-shaped rod, the rigidity of the U-shaped rod is greater than the rigidity of the connecting rod 136. This ensures that the end piece 134 can maintain the overall spiral structure of the score wire 132 of the wire knife 130 during the inflation of the balloon 120, improving the overall stability of the structure, and also facilitates the elastic deformation of the connecting rod 136, which is beneficial to increase the radial expansion diameter of the score wire 132 and prevent the occurrence of incomplete opening caused by the spiral locking of one end of the balloon 120.

In one embodiment, the side of score wire 132 adjacent the outer surface of balloon 120 is curved, which conforms to the shape of the outer surface of balloon 120. The curved surface design can make the scored line 132 better fit the balloon 120, thereby being more beneficial to uncoiling and tightening the scored line 132 when the balloon 120 is expanded or contracted, and reducing the damage of the scored line 132 with a sharp angle to the balloon 120. In one embodiment, the side of the U-shaped rod near the outer surface of the balloon 120 is curved, which conforms to the shape of the outer surface of the balloon 120. In one embodiment, the side of the connecting rod 136 adjacent to the outer surface of the balloon 120 is curved, which conforms to the shape of the outer surface of the balloon 120. As an example, the side of each component of the silk knife 130 of the present disclosure close to the outer surface of the balloon 120 is curved, so that when the silk knife 130 is mounted on the surface of the balloon 120, the surface of the balloon 120 can be better fitted, and the damage of each component, especially the scored line 132 with sharp corners, to the balloon 120 can be reduced.

In one embodiment, the wire cutter 130 may cut the raw metal pipe according to a design drawing by laser cutting or machining to form a wire cutter, and then perform post-treatment processes such as acid washing, sand blasting, polishing, and the like on the cut wire cutter to finally form the required wire cutter. The material of the wire cutter 130 is preferably nitinol or other memory-related material. Therefore, when the balloon device is used, the initial state of the scoring wire is quickly restored by virtue of the memory function of the material of the silk knife 130, so that the outer diameter of the scoring wire 132 is hidden or shielded by the leaf flaps 124 of the balloon 120 on both sides of the groove 122 again, and the scoring wire 132 with a sharp angle cannot directly contact the inner wall of the blood vessel, thereby avoiding the scoring wire 132 scratching the blood vessel during the retraction process of the balloon 120 to cause complications.

The embodiment of the disclosure provides a sacculus device and a silk knife that is used for the sacculus device, through the nick silk that shields the silk knife in sacculus transportation process, has further improved sacculus device compliance and trafficability characteristic, has avoided among the transportation process sacculus device to normal vascular inner wall fish tail, has improved sacculus device's factor of safety, reduces the operation risk. The embodiment of the disclosure adopts a triangle-like nicking wire structure, and the sharp angle design of the nicking wire structure is beneficial to cutting of a wire cutter on a blood vessel pathological change part during balloon expansion, and on the other hand, because of the sharp angle stress concentration, a higher cutting force can be provided under the same balloon expansion pressure, and the wire cutter can cut a plaque more easily, thereby effectively treating a hardened plaque blood vessel stenosis disease.

The following points need to be explained:

(1) the drawings of the embodiments of the disclosure only relate to the structures related to the embodiments of the disclosure, and other structures can refer to common designs.

(2) Without conflict, embodiments of the present disclosure and features of the embodiments may be combined with each other to arrive at new embodiments.

The above description is only a specific embodiment of the present disclosure, but the scope of the present disclosure is not limited thereto, and the scope of the present disclosure should be subject to the scope of the claims.

Claims

1. A wire cutter, comprising:

more than 2 indented wires are spirally wound to form a spiral structure;

the end pieces are respectively arranged at two ends of the spiral structure and comprise an annular structure, and the annular structure comprises a plurality of U-shaped rods which are connected end to end; and

connecting rod more than 2, every 1 is connected respectively at the both ends of connecting rod nick silk and 1 the U-shaped pole, connecting rod edge more than 2 helical structure's axial extension and parallel to each other.

2. The wire cutter of claim 1, wherein the diameter of the ring structure is less than the diameter of the helix structure.

3. The silk knife of claim 1, wherein the cross-section of the U-shaped bar and/or the connecting bar is rectangular-like and the cross-sectional area of the connecting bar is less than the cross-sectional area of the U-shaped bar.

4. The wire knife of claim 1, wherein the cross-section of the scored wire is rectangular-like or triangular-like.

5. The wire knife of claim 1 wherein the cross-section of the scored wire is isosceles or equilateral-like.

6. The wire knife of claim 1 wherein said 2 or more scored wires are evenly distributed in the circumferential direction and are arranged in parallel to each other and spirally wound in the same direction.

7. A balloon apparatus, comprising:

a wire cutter according to any one of claims 1-6;

a balloon having an expanded state and a contracted state; and

an outer tube, a proximal end of the balloon being connected to a distal end of the outer tube,

the far end of the silk knife is fixedly connected with the far end of the balloon, the scoring wire is spirally wound on the outer surface of the balloon along the axial direction of the balloon, and the cross section of the scoring wire has at least one sharp angle in the radial outward direction of the spiral structure.

8. The balloon apparatus according to claim 7, further comprising an elastic tube disposed on an outer surface of the outer tube distal end, the distal end of the elastic tube being connected to the proximal end of the wire cutter.

9. The balloon apparatus according to claim 7, wherein a side of the connecting rod and/or the score wire adjacent to the outer surface of the balloon is a curved surface that matches the shape of the outer surface of the balloon.

10. The balloon apparatus according to claim 7, wherein each of the scored wires has a winding length in a circumferential direction of more than one circumference.

11. The balloon device according to claim 7, wherein when the balloon is in the contracted state, the outer surface of the balloon is spirally provided with more than 2 grooves, the depth of each groove is equal to or greater than the radial height of the score line, and each score line is embedded in 1 groove; when the balloon is in the expanded state, an outer surface of the balloon is extended such that the sharp corners of the score wires are convex to the outer surface of the balloon.