CN112472228B - Calcified plaque cutting balloon - Google Patents
Calcified plaque cutting balloon Download PDFInfo
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- CN112472228B CN112472228B CN202011395418.9A CN202011395418A CN112472228B CN 112472228 B CN112472228 B CN 112472228B CN 202011395418 A CN202011395418 A CN 202011395418A CN 112472228 B CN112472228 B CN 112472228B
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- Prior art keywords
- cutting
- balloon
- wire
- cutting wire
- elastic
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B17/320758—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions with a rotating cutting instrument, e.g. motor driven
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/32—Surgical cutting instruments
- A61B17/3205—Excision instruments
- A61B17/3207—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions
- A61B2017/320741—Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions for stripping the intima or the internal plaque from a blood vessel, e.g. for endarterectomy
Abstract
The invention discloses a calcified plaque cutting balloon, which comprises: the balloon main body, the cutting wire, the elastic telescopic parts and the cutting wire are fixed on the elastic telescopic parts at two ends of the balloon main body and are distributed on the outer surface of the balloon main body in parallel along the axial direction. The balloon catheter has the advantages that the cutting wires are distributed on the outer side of the balloon body in an axially parallel mode, the lesion part can be regularly cut under lower pressure, meanwhile, the balloon catheter has good capability of penetrating complex lesions, the balloon catheter connecting structure is a special-shaped multi-cavity elastic tube with good elasticity, the cutting part can perform axial elastic telescopic movement, and the banana effect is prevented; meanwhile, the shape design of the cutting wire greatly reduces the contact area with a lesion part, reduces the sliding risk of the balloon in the expansion process, and improves the cutting and expansion capabilities of the balloon on fibrotic lesions and plaques.
Description
Technical Field
The invention relates to the technical field of medical instruments, in particular to a calcified plaque cutting balloon for dilating and treating coronary vessel fibrocalcified lesion and in-stent restenosis (ISR) in PCI (peripheral component interconnect) operation.
Background
Vascular intervention therapy is an important treatment mode for revascularization treatment of stenotic lesions. In vascular interventional therapy, a balloon catheter is generally used as a main vascular interventional therapy instrument. For some intravascular stenoses, such as calcifications, plaques or fibrosis, the common balloon catheter cannot expand the stenoses. To solve this problem, some medical device companies have developed cutting balloons for expanding the stenotic lesion.
The balloons used at the present stage with a cutting action comprise: a blade cutting balloon, a single wire cutting balloon, a multi-wire cutting balloon.
Before the blade cutting saccule expands, the blade is tightly wrapped on the folding saccule, when reaching the pathological change expansion saccule, the blade extends out of the saccule to regularly cut the pathological changes of the blood vessel, the irregular tearing of the blood vessel caused by the mode is small, and the restenosis can be reduced. However, the stainless steel blade is hard, so that the blade balloon has the defects of poor penetrability and difficulty in reaching a lesion part through a complicated tortuous blood vessel, and the sharp edge easily causes excessive cutting on the inner membrane or the inner wall of the blood vessel to damage the blood vessel.
The guide wire cutting saccule is generally divided into a single guide wire saccule, a double guide wire saccule and a multi-guide wire saccule, and similar cutting operation is carried out on calcified, plaque or fibrotic lesion parts through the guide wires. Generally speaking, some single-guide-wire and double-guide-wire balloons in the market have better trafficability, but have poor cutting effect on calcified or fibrotic lesion parts, and balloon sliding and banana effect are easy to occur after expansion. The multi-guide-wire cutting saccule on the market has the defects of poor trafficability and difficulty in reaching a lesion part through a complex tortuous blood vessel, and the cutting assembly of the multi-guide-wire cutting saccule is generally a round wire or a flat wire, so that the cutting effect on calcified lesions cannot achieve an ideal effect.
Therefore, there is a need for a novel cutting balloon that can effectively cut and expand a complicated stenotic lesion while easily passing through the lesion.
Disclosure of Invention
Aiming at the defects in the prior art, the invention provides a calcified plaque cutting balloon which is used for solving the technical problems that the balloon has poor penetrability and avoids excessive cutting of a lesion part.
The invention provides a calcified plaque cutting balloon, aiming at improving the trafficability of the cutting balloon, enabling the cutting balloon to reach a lesion through a complex tortuous blood vessel, realizing effective cutting and simultaneously reducing the damage to the blood vessel.
The invention aims to solve the technical problem of how to improve the passing performance of a balloon, so that the balloon can reach a lesion through a complex tortuous blood vessel, realize effective cutting and reduce the damage to the blood vessel.
In order to achieve the purpose, the invention adopts the technical scheme that: a calcified plaque cutting balloon, comprising: a catheter assembly provided with an inner tube; a balloon body through which the inner tube passes and forms a tip at a distal end; the n cutting wires are axially distributed on the periphery of the balloon main body in parallel and are axially parallel to the balloon main body, wherein n is an integer greater than or equal to 2; at least one of the proximal end and the distal end of the cutting wire is connected to the catheter assembly or the tip through an elastic telescopic component; the cutting wire comprises a cutting section positioned in the middle and non-cutting sections positioned at two ends, and the wire diameter of the non-cutting sections is smaller than that of the cutting section.
In the technical scheme, the elastic telescopic part is an elastic multi-cavity tube, the product of the length L of the elastic multi-cavity tube and the yield elongation A of the elastic multi-cavity tube is not less than the moving distance S of the cutting wire under the condition of no other external force when the balloon is expanded, namely L A is not less than S, the elastic multi-cavity tube comprises a central tube with elastic stretching property and m outer tubes uniformly distributed along the periphery of the central tube, the inner tubes penetrate through the central tube, m is an integer greater than or equal to 2, the number of the outer tubes is equal to that of the cutting wires, and the outer tubes are connected with the end parts of the cutting wires.
In the above technical scheme, the end of the cutting wire is inserted into the outer tube and fixed.
In the above technical scheme, the cross-sectional shape of the cutting wire with the two ends being thin in wire diameter is circular
In the technical scheme, the diameter range of the cutting wire is 0.05-0.5 mm.
In the technical scheme, the end part of the elastic telescopic part and the end part of the balloon main body have a relative axial moving range of 0.5-5 cm.
The invention has the beneficial effects that:
1. and a reducing cutting wire design is adopted.
a. Compared with the prior art, the balloon cutting device has the advantages that the size of the balloon passing through the cross section is reduced, the complex lesion throughput capacity is improved, better cutting and expansion effects are formed on calcified lesions and restenosis in a stent, and excessive cutting of a vessel wall cannot be caused.
b. The thin non-cutting sections at the two ends of the cutting wire are soft, so that the cutting sections can be better attached to the balloon wall, the cutting sections and the balloon are prevented from shifting in cutting, and the balloon is prevented from sliding in the expansion process.
2. Adopts the fixing mode of an elastic telescopic part.
The simple mode for fixing the cutting wire is provided, so that a sufficient axial relative movement space is formed between the cutting device consisting of the cutting wire and the elastic tube and the balloon body, and the cutting wire is prevented from being broken or falling off due to the banana effect of the balloon and the overlarge tension of the cutting wire after the balloon is expanded; after the balloon is decompressed, the elastic multi-cavity tube loses stress, and the cutting wire is pulled to be tightly attached to the balloon wall in the process of recovering the original size, so that the balloon catheter is withdrawn from the blood vessel after expansion.
Drawings
Fig. 1 is a schematic structural view of a calcified plaque cutting balloon provided in an embodiment of the present invention.
Fig. 2 is a schematic cross-sectional view of the elastically stretchable member of the present invention.
FIG. 3 is an axial structural view of the variable diameter cutting wire of the present invention.
FIG. 4 is a schematic view of the radial structure of the variable diameter cutting wire of the present invention.
Fig. 5 is a cross-sectional view of the cutting balloon of the present invention in a folded state.
Detailed Description
In order to make the objects, technical solutions and advantages of the present application more apparent, the present application will be described and illustrated below with reference to the accompanying drawings and embodiments. It should be understood that the specific embodiments described herein are merely illustrative of the present application and are not intended to limit the present application. All other embodiments obtained by a person of ordinary skill in the art based on the embodiments provided in the present application without any inventive step are within the scope of protection of the present application. Moreover, it should be appreciated that in the development of any such actual implementation, as in any engineering or design project, numerous implementation-specific decisions must be made to achieve the developers' specific goals, such as compliance with system-related and business-related constraints, which may vary from one implementation to another.
Reference in the specification to "an embodiment" means that a particular feature, structure, or characteristic described in connection with the embodiment can be included in at least one embodiment of the specification. The appearances of the phrase in various places in the specification are not necessarily all referring to the same embodiment, nor are separate or alternative embodiments mutually exclusive of other embodiments. It is to be expressly and implicitly understood by one of ordinary skill in the art that the embodiments described herein may be combined with other embodiments without conflict.
Unless defined otherwise, technical or scientific terms referred to herein shall have the ordinary meaning as understood by those of ordinary skill in the art to which this application belongs. Reference to "a," "an," "the," and similar words throughout this application are not to be construed as limiting in number, and may refer to the singular or the plural. The present application is directed to the use of the terms "including," "comprising," "having," and any variations thereof, which are intended to cover non-exclusive inclusions; for example, a process, method, system, article, or apparatus that comprises a list of steps or modules (elements) is not limited to the listed steps or elements, but may include other steps or elements not expressly listed or inherent to such process, method, article, or apparatus. Reference to "connected," "coupled," and the like in this application is not intended to be limited to physical or mechanical connections, but may include electrical connections, whether direct or indirect. Reference herein to "a plurality" means greater than or equal to two. "and/or" describes an association relationship of associated objects, meaning that three relationships may exist, for example, "A and/or B" may mean: a exists alone, A and B exist simultaneously, and B exists alone. Reference herein to the terms "first," "second," "third," and the like, are merely to distinguish similar objects and do not denote a particular ordering for the objects.
As shown in fig. 1, a schematic structural view of the calcified plaque cutting balloon provided in this embodiment is shown, and the calcified plaque cutting balloon is composed of a tip 1, an elastic telescopic component 2, a diameter-variable cutting wire 3, a balloon body, a developing ring 5, an inner tube 6, and a catheter assembly 7. The inner tube 6 passes through the elastically telescoping member 2, balloon body 4, catheter assembly 7 and tip 1. The developing ring 5 is fixed to the inner tube 2.
The balloon body 4 is a semi-compliant or non-compliant balloon.
As shown in figure 1, the cutting wire is processed by n (n is more than or equal to 2) medical grade metal wires. The structure of the metal wire is shown in figure 3, and the diameter range of the metal wire is 0.05-0.50 mm. The thinner section, which is the non-cutting section 11, is circular and covers the thicker section of the balloon, which is the cutting section 10, and has a triangular or other geometric cross-section. The included angle of two adjacent cutting wires is 360 degrees/n. The cutting wire is made of stainless steel, nickel-titanium alloy, polymer and other materials. Due to the design of the reducing cutting wire, the sectional area of the metal wire at the non-cutting part is reduced, the diameter of the connecting part of the metal wire and the saccule is reduced, the cutting wire is more flexible, and the passing capacity of the cutting saccule under complex pathological changes is improved; make better laminating of wire and sacculus after the expansion, reduce the slip of wire and sacculus in the expansion process, play good sacculus antiskid function. Meanwhile, the cutting section of the metal wire is thick, so that the cutting effect on the plaque is ensured.
As shown in figure 1, the proximal part of the elastic telescopic component 2 is welded with a duct component 7, and a movable part of 0.5-5 cm is reserved at the distal end. Most advanced 1 is fixed with the distal end pin of sacculus main part 4, and the multicavity pipe (for elastic expansion part or non-elastic expansion part all can) of 1 afterbody in most advanced reserves 0.5~3 mm's length and does not weld with the distal end of sacculus main part, remains multicavity pore structure. The elastic expansion part 2 is made of high-elasticity medical polymer material, including but not limited to Pebax, polyurethane, silica gel, etc. The junction of the tip and the balloon body forms a smooth curve that allows the tip to better navigate stenotic lesions.
As shown in fig. 2, 3 and 4, two end non-cutting segments 11 of the three cutting wires 3 are fixed in the tip 1 and the outer tube 8 of the elastic telescopic component 2 (elastic multi-cavity tube) and are connected by glue, welding and other processes; while the central tube 9 is sleeved outside the inner tube 6. Through the design of the elastic multi-cavity tube of the elastic telescopic component, an enough axial relative movement space between the cutting wire and the balloon is provided, the balloon is prevented from being excessively extruded or the banana effect is avoided after expansion, and meanwhile, the elastic component pulls the metal wire to retract after pressure relief, so that the balloon is favorably withdrawn or expanded again.
As shown in fig. 5, the thicker portion 10 of the cutting wire is axially parallel to the balloon and is wrapped within the balloon-folded flap 12 without damaging the normal blood vessel that is routed during delivery. After the sacculus in the blood vessel is pressurized, the cutting wires are uniformly distributed on the surface of the sacculus, and the cutting effect on the plaque is achieved.
Wherein, the surfaces of the tip 1, the balloon body 4 and the elastic telescopic part 2 are coated with hydrophilic coatings, so that the permeability of the balloon is improved.
Wherein, two developing rings 5 are fixed on the inner tube 6 and used for positioning in operation. The inner cavity of the inner tube 6 is of a hollow structure, and the head opening of the inner cavity is communicated with the central tube 9 of the elastic telescopic part 2.
In addition, in other embodiments, the metal cutting member may be welded and fixed by sandwiching the metal cutting member between two layers of elastic tubes, one end of which is welded and fixed to the duct assembly, after the cutting wire is wound, bent, cut, etc. at both ends. The cutting wire component and the balloon can move relatively to each other by fixing a mechanical structure or a device with elasticity at the near end and the far end or one end of the balloon to be connected with the cutting wire.
In the embodiment of the application, the cutting guide wire in the prior art is usually a metal flat wire or a metal/polymer material round wire, and the cutting effect is poor; adopt reducing cutting wire in this application, can reduce cutting wire and pathological change area of contact, improve cutting effect under the equal pressure.
The cutting wire is hard, the cutting wire cannot be well attached to the balloon wall after expansion, the contact area of the cutting wire and the balloon is small, and the cutting wire and the balloon easily slide relatively. This application adopts axially parallel's reducing wire design, reduces the diameter of non-cutting position wire, makes it softer, and the expansion back wire laminates with the sacculus outer wall more, reduces the problem that cutting wire and sacculus take place relative aversion in the sacculus expansion, improves the holistic non-skid property of sacculus.
The fixing mode of the cutting wire in the prior technical scheme can not provide enough axial relative motion space between the cutting wire and the balloon body, the balloon is easy to extrude or the banana effect occurs after expansion, and the risk that the cutting wire and the connecting part fall off due to overlarge rigid tension exists. Cutting silk and the connection that has the elasticity and can stretch the flexible part in this application provide cutting silk and sacculus relative motion space, improve "banana effect" and reduce the risk of droing.
The working principle of the invention is as follows: when the cutting saccule is used, the saccule flap in a folded state tightly wraps the cutting wire and is conveyed through the conveying sheath tube and the guide catheter, and when the cutting wire passes through the blood vessel part, the normal blood vessel of the passing path can not be damaged. After reaching the lesion, the cutting wire extends out of the outer surface of the balloon along with the expansion of the balloon main body to regularly cut the plaque; the irregular tear of the intima of the blood vessel is small, the interlayer and the plaque falling off are avoided, and the incidence rate of restenosis is reduced. Meanwhile, the cutting wire plays a role in anchoring, and the interlayer generated due to sliding of the saccule in the expansion process is prevented.
The above examples are intended to illustrate rather than to limit the invention, and all equivalent changes and modifications made by the methods described in the claims of the present invention are intended to be included within the scope of the present invention.
Claims (4)
1. A calcified plaque cutting balloon, comprising:
a catheter assembly provided with an inner tube;
a balloon body through which the inner tube passes and forms a tip at a distal end; and
n cutting wires are axially distributed on the periphery of the balloon main body in parallel and are axially parallel to the balloon main body, wherein n is an integer greater than or equal to 2; at least one of the proximal end and the distal end of the cutting wire is connected to the catheter component or the tip through an elastic telescopic component;
the cutting wire comprises a cutting section positioned in the middle and non-cutting sections positioned at two ends, and the wire diameter of the non-cutting sections is smaller than that of the cutting section; the elastic telescopic component is an elastic multi-cavity tube, and the joint of the tip and the balloon main body forms a smooth radian; the product of the length L of the elastic multi-cavity tube and the yield elongation A thereof is not less than the moving distance S of the cutting wire under the condition of no other external force when the balloon is expanded, namely L A is not less than S, the elastic multi-cavity tube comprises a central tube with elastic and stretchable characteristics and m outer tubes uniformly distributed along the periphery of the central tube, the inner tubes penetrate through the central tube, wherein m is an integer greater than or equal to 2, the number of the outer tubes is equal to that of the cutting wire, and the outer tubes are connected with the end parts of the cutting wire; the diameter range of the cutting wire is 0.05-0.5 mm.
2. The calcified plaque cutting balloon of claim 1, wherein: the fixing mode of the end part of the cutting wire and the outer pipe comprises one of adhesive bonding, welding and mechanical structure riveting.
3. The calcified plaque cutting balloon of claim 1, wherein: the section of the cutting wire with the two ends being thin is circular.
4. The calcified plaque cutting balloon of claim 1, wherein: the end part of the elastic telescopic part and the end part of the balloon main body have a relative axial moving range of 0.5-5 cm.
Priority Applications (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011395418.9A CN112472228B (en) | 2020-12-03 | 2020-12-03 | Calcified plaque cutting balloon |
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| CN202011395418.9A CN112472228B (en) | 2020-12-03 | 2020-12-03 | Calcified plaque cutting balloon |
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| Publication Number | Publication Date |
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| CN112472228A CN112472228A (en) | 2021-03-12 |
| CN112472228B true CN112472228B (en) | 2022-05-06 |
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| Application Number | Title | Priority Date | Filing Date |
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| CN202011395418.9A Active CN112472228B (en) | 2020-12-03 | 2020-12-03 | Calcified plaque cutting balloon |
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Families Citing this family (9)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN113208702A (en) * | 2021-04-29 | 2021-08-06 | 广东博迈医疗科技股份有限公司 | Cutting wire fixing structure and cutting balloon catheter |
| CN113425380A (en) * | 2021-06-01 | 2021-09-24 | 青岛博泰医疗器械有限责任公司 | Balloon catheter for linear segmentation of glandular tissue |
| CN113413197B (en) * | 2021-06-30 | 2022-04-29 | 哈尔滨医科大学 | Rotary-cut seal wire and calcified lesion tearing device |
| CN113648023B (en) * | 2021-07-05 | 2023-06-16 | 科凯(南通)生命科学有限公司 | Repairing saccule for treating thrombus and calcified lesion |
| CN113877045B (en) * | 2021-11-18 | 2023-03-10 | 科塞尔医疗科技（苏州）有限公司 | Balloon catheter |
| CN114098902B (en) * | 2021-12-02 | 2023-12-15 | 山东吉威医疗制品有限公司 | Silk knife and sacculus device |
| CN114469322B (en) * | 2022-01-25 | 2022-08-23 | 广东博迈医疗科技股份有限公司 | Cutting actuating mechanism and cutting balloon catheter |
| CN115317766B (en) * | 2022-08-18 | 2023-03-28 | 广东博迈医疗科技股份有限公司 | Cutting balloon catheter with hidden blades |
| CN116271455B (en) * | 2023-05-22 | 2023-08-01 | 杭州亿科医疗科技有限公司 | Force-gathering expansion saccule for directional breaking vascular calcification lesion |
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| CN103949002A (en) * | 2014-05-04 | 2014-07-30 | 广东博迈医疗器械有限公司 | Single-guide wire cutting balloon catheter |
| CN209107491U (en) * | 2017-11-07 | 2019-07-16 | 上海形状记忆合金材料有限公司 | A kind of Cutting balloon |
| CN111135433A (en) * | 2020-03-06 | 2020-05-12 | 广东博迈医疗器械有限公司 | Balloon catheter |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| WO2006122573A1 (en) * | 2005-05-17 | 2006-11-23 | Syntach Ag | A device a kit for treatment of disorders in the heart rhythm regulation system |
| CN107496009B (en) * | 2017-10-16 | 2023-11-28 | 广东博迈医疗科技股份有限公司 | Vascular plaque cutting device |
| CN109893215B (en) * | 2017-12-11 | 2022-10-04 | 先健科技(深圳)有限公司 | Cutting balloon catheter |
| CN108577937B (en) * | 2018-05-18 | 2020-09-18 | 鼎科医疗技术（苏州）有限公司 | Cutting balloon and balloon catheter |
| CN111821016A (en) * | 2019-04-23 | 2020-10-27 | 广州医科大学附属第一医院（广州呼吸中心） | Electrotome, treatment equipment with electrotome, control method and control device |
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Patent Citations (3)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN103949002A (en) * | 2014-05-04 | 2014-07-30 | 广东博迈医疗器械有限公司 | Single-guide wire cutting balloon catheter |
| CN209107491U (en) * | 2017-11-07 | 2019-07-16 | 上海形状记忆合金材料有限公司 | A kind of Cutting balloon |
| CN111135433A (en) * | 2020-03-06 | 2020-05-12 | 广东博迈医疗器械有限公司 | Balloon catheter |
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