CN106821457A - One kind carries medicine Cutting balloon - Google Patents
One kind carries medicine Cutting balloon Download PDFInfo
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- CN106821457A CN106821457A CN201710126716.XA CN201710126716A CN106821457A CN 106821457 A CN106821457 A CN 106821457A CN 201710126716 A CN201710126716 A CN 201710126716A CN 106821457 A CN106821457 A CN 106821457A
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- 238000005520 cutting process Methods 0.000 title claims abstract description 102
- 239000003814 drug Substances 0.000 title claims abstract description 91
- 229940079593 drug Drugs 0.000 claims abstract description 90
- 210000004204 blood vessel Anatomy 0.000 claims abstract description 30
- 239000011248 coating agent Substances 0.000 claims abstract description 17
- 238000000576 coating method Methods 0.000 claims abstract description 17
- 230000003902 lesion Effects 0.000 claims abstract description 8
- 230000000994 depressogenic effect Effects 0.000 claims description 3
- 238000002560 therapeutic procedure Methods 0.000 claims 1
- 230000002966 stenotic effect Effects 0.000 abstract description 4
- 239000002775 capsule Substances 0.000 abstract description 2
- 208000031481 Pathologic Constriction Diseases 0.000 abstract 1
- 230000036262 stenosis Effects 0.000 abstract 1
- 208000037804 stenosis Diseases 0.000 abstract 1
- 238000000034 method Methods 0.000 description 7
- 230000000916 dilatatory effect Effects 0.000 description 3
- 238000012377 drug delivery Methods 0.000 description 3
- 206010057469 Vascular stenosis Diseases 0.000 description 2
- 210000001367 artery Anatomy 0.000 description 2
- 239000008280 blood Substances 0.000 description 2
- 210000004369 blood Anatomy 0.000 description 2
- 230000008602 contraction Effects 0.000 description 2
- 230000010339 dilation Effects 0.000 description 2
- 230000000694 effects Effects 0.000 description 2
- 239000002861 polymer material Substances 0.000 description 2
- 239000004094 surface-active agent Substances 0.000 description 2
- 231100000216 vascular lesion Toxicity 0.000 description 2
- 201000001320 Atherosclerosis Diseases 0.000 description 1
- 239000004677 Nylon Substances 0.000 description 1
- 239000004952 Polyamide Substances 0.000 description 1
- 239000004698 Polyethylene Substances 0.000 description 1
- 239000002202 Polyethylene glycol Substances 0.000 description 1
- 208000001106 Takayasu Arteritis Diseases 0.000 description 1
- 230000015572 biosynthetic process Effects 0.000 description 1
- 210000001715 carotid artery Anatomy 0.000 description 1
- 210000001627 cerebral artery Anatomy 0.000 description 1
- 210000004351 coronary vessel Anatomy 0.000 description 1
- 238000001647 drug administration Methods 0.000 description 1
- 150000002148 esters Chemical class 0.000 description 1
- 239000003292 glue Substances 0.000 description 1
- 206010020718 hyperplasia Diseases 0.000 description 1
- 239000007788 liquid Substances 0.000 description 1
- 210000003141 lower extremity Anatomy 0.000 description 1
- 239000007769 metal material Substances 0.000 description 1
- 229920001778 nylon Polymers 0.000 description 1
- 229920002647 polyamide Polymers 0.000 description 1
- -1 polyethylene Polymers 0.000 description 1
- 229920000573 polyethylene Polymers 0.000 description 1
- 229920001223 polyethylene glycol Polymers 0.000 description 1
- 229920000223 polyglycerol Polymers 0.000 description 1
- 229950008882 polysorbate Drugs 0.000 description 1
- 229920000136 polysorbate Polymers 0.000 description 1
- 229920002635 polyurethane Polymers 0.000 description 1
- 239000004814 polyurethane Substances 0.000 description 1
- 229920000915 polyvinyl chloride Polymers 0.000 description 1
- 239000004800 polyvinyl chloride Substances 0.000 description 1
- 238000001959 radiotherapy Methods 0.000 description 1
- 208000037803 restenosis Diseases 0.000 description 1
- 230000009885 systemic effect Effects 0.000 description 1
- 230000001225 therapeutic effect Effects 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
Classifications
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/32—Surgical cutting instruments
- A61B17/3209—Incision instruments
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M29/00—Dilators with or without means for introducing media, e.g. remedies
- A61M29/02—Dilators made of swellable material
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22051—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation
- A61B2017/22061—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for with an inflatable part, e.g. balloon, for positioning, blocking, or immobilisation for spreading elements apart
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/22—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for
- A61B2017/22082—Implements for squeezing-off ulcers or the like on inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; for invasive removal or destruction of calculus using mechanical vibrations; for removing obstructions in blood vessels, not otherwise provided for after introduction of a substance
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- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- Engineering & Computer Science (AREA)
- Biomedical Technology (AREA)
- Heart & Thoracic Surgery (AREA)
- Public Health (AREA)
- General Health & Medical Sciences (AREA)
- Surgery (AREA)
- Molecular Biology (AREA)
- Medical Informatics (AREA)
- Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
- Vascular Medicine (AREA)
- Anesthesiology (AREA)
- Hematology (AREA)
- Orthopedic Medicine & Surgery (AREA)
- Media Introduction/Drainage Providing Device (AREA)
Abstract
本发明提供了一种载药切割球囊，用于在介入治疗中通过导管导入人体血管内从而对血管内壁上的病灶进行切割及给药，其特征在于，包括：球囊本体，呈空心椭圆球状；以及多组切割刀组，设置在球囊本体的表面上，每组切割刀组包括多个设置在同一圆周上的切割刀片，其中，切割刀片沿着球囊本体的圆周方向延伸，球囊本体上设置有多个载药区，用于涂布药物。本发明提供的载药切割球囊中，切割刀片沿球囊本体的圆周方向延伸，因此在收缩状态下球囊本体容易通过迂曲的血管到达血管狭窄部位，在球囊本体膨胀状态下进行切割时不容易发生受力不均匀的情况，能够更好地对具有钙化斑块血管狭窄部位进行切割和扩张。
The invention provides a drug-loaded cutting balloon, which is used for cutting and administering drugs to the lesions on the inner wall of the blood vessel by introducing it into the blood vessel of the human body through a catheter during interventional treatment. Spherical; and multiple groups of cutting knife groups, arranged on the surface of the balloon body, each group of cutting knife groups includes a plurality of cutting blades arranged on the same circumference, wherein the cutting blades extend along the circumferential direction of the balloon body, and the ball The capsule body is provided with a plurality of drug-loading regions for coating drugs. In the drug-loaded cutting balloon provided by the present invention, the cutting blade extends along the circumferential direction of the balloon body. Therefore, in the contracted state, the balloon body can easily reach the stenotic part of the blood vessel through the tortuous blood vessel. It is less prone to uneven stress, and can better cut and expand the stenosis of blood vessels with calcified plaques.
Description
技术领域technical field
本发明属于医疗器械领域，涉及一种切割球囊，具体涉及一种载药切割球囊。The invention belongs to the field of medical devices and relates to a cutting balloon, in particular to a drug-loaded cutting balloon.
背景技术Background technique
血管狭窄是一种血管病变，可能发生在冠状动脉、脑动脉、颈动脉以及下肢动脉等全身动脉中，其成因主要是动脉粥样硬化、多发性大动脉炎和放射治疗等。Vascular stenosis is a vascular lesion that may occur in systemic arteries such as coronary arteries, cerebral arteries, carotid arteries, and arteries of the lower extremities. Its main causes are atherosclerosis, Takayasu and radiation therapy.
目前，临床中多采用球囊扩张法或置入支架法这样的介入治疗方式来对发生血管狭窄的部位进行扩张，但这种方法容易对血管内膜产生刺激使内膜增生并导致血管再狭窄。另外，在一些钙化严重的血管狭窄病变中，球囊难以将血管进行充分扩张，支架在这样的血管中也难以释放完全，因而传统的球囊扩张法和置入支架法难以达到良好的治疗效果。At present, interventional treatment methods such as balloon dilation or stent placement are often used in clinical practice to dilate the stenotic part of the blood vessel, but this method is likely to stimulate the intima of the blood vessel, cause intima hyperplasia and lead to vascular restenosis . In addition, in some severely calcified vascular stenosis lesions, it is difficult for the balloon to fully expand the blood vessel, and it is also difficult for the stent to be fully released in such a blood vessel. Therefore, the traditional balloon dilation method and stent placement method are difficult to achieve a good therapeutic effect. .
为了解决上述技术问题，现有技术中出现了一些切割球囊。这些切割球囊的表面设有纵向延伸的刀片，在扩张的同时能够对钙化斑块进行切割，使血管能够被充分扩张。但是，这样的纵向刀片不仅使球囊收缩状态下难以顺利通过迂曲的血管，在球囊膨胀状态下对钙化斑块进行切割时还容易受力不均匀，导致切割不完全或切割过度。另外，在一些多发性大动脉炎的治疗过程中，血管狭窄的部位还需要给药，这样的切割球囊也无法在扩张血管的同时进行给药操作。In order to solve the above-mentioned technical problems, some cutting balloons have appeared in the prior art. The surface of these cutting balloons is provided with longitudinally extending blades, which can cut the calcified plaque while expanding, so that blood vessels can be fully expanded. However, such a longitudinal blade not only makes it difficult for the balloon to pass through the tortuous blood vessel smoothly when the balloon is inflated, but also tends to receive uneven force when cutting the calcified plaque when the balloon is inflated, resulting in incomplete or excessive cutting. In addition, during the treatment of some Takayasu arteritis, the narrowed part of the blood vessel needs to be administered, and such a cutting balloon cannot perform the operation of administering the drug while dilating the blood vessel.
发明内容Contents of the invention
为解决上述问题，提供一种容易通过迂曲的血管、在切割钙化斑块时受力均匀并且还能够实现给药的切割球囊，本发明采用了如下技术方案：In order to solve the above problems and provide a cutting balloon that is easy to pass through tortuous blood vessels, has a uniform force when cutting calcified plaques, and can also achieve drug delivery, the present invention adopts the following technical solutions:
本发明提供了一种载药切割球囊，用于在介入治疗中通过导管导入人体血管内从而对血管内壁上的病灶进行切割及给药，其特征在于，包括：球囊本体，呈空心椭圆球状；以及多组切割刀组，设置在球囊本体的表面上，每组切割刀组包括多个设置在同一圆周上的切割刀片，其中，切割刀片沿着球囊本体的圆周方向延伸，球囊本体上设置有多个载药区，用于涂布药物。The invention provides a drug-loaded cutting balloon, which is used for cutting and administering drugs to lesions on the inner wall of blood vessels by introducing a catheter into human blood vessels during interventional treatment. Spherical; and multiple groups of cutting knife groups, arranged on the surface of the balloon body, each group of cutting knife groups includes a plurality of cutting blades arranged on the same circumference, wherein the cutting blades extend along the circumferential direction of the balloon body, and the ball The capsule body is provided with multiple drug-loading regions for coating drugs.
本发明提供的载药切割球囊，还可以具有如下技术特征：其中，载药区的柔性大于球囊本体的其他区域，使球囊本体收缩时该载药区凹陷在球囊表面以下，球囊本体膨胀时该载药区凸出球囊本体表面。The drug-loaded cutting balloon provided by the present invention can also have the following technical features: wherein, the flexibility of the drug-loaded area is greater than that of other areas of the balloon body, so that the drug-loaded area is depressed below the surface of the balloon when the balloon body contracts, and the balloon When the balloon body is inflated, the drug-loaded area protrudes from the surface of the balloon body.
本发明提供的载药切割球囊，还可以具有如下技术特征：其中，载药区分别位于切割刀组之间。The drug-loaded cutting balloon provided by the present invention may also have the following technical features: wherein, the drug-loaded regions are respectively located between the cutting knife groups.
本发明提供的载药切割球囊，还可以具有如下技术特征：其中，载药区表面具有载药涂层。The drug-loaded cutting balloon provided by the present invention may also have the following technical features: wherein, the surface of the drug-loaded area has a drug-loaded coating.
本发明提供的载药切割球囊，还可以具有如下技术特征：其中，切割刀片的长度小于1mm。The drug-loaded cutting balloon provided by the present invention may also have the following technical features: wherein, the length of the cutting blade is less than 1 mm.
本发明提供的载药切割球囊，还可以具有如下技术特征：其中，每组切割刀组包括三个以上切割刀片。The drug-loaded cutting balloon provided by the present invention may also have the following technical features: wherein, each group of cutting blades includes more than three cutting blades.
本发明提供的载药切割球囊，还可以具有如下技术特征：其中，切割刀片上设置有显影环。The drug-loaded cutting balloon provided by the present invention may also have the following technical features: wherein, the cutting blade is provided with a developing ring.
发明作用与效果Invention function and effect
根据本发明提供的载药切割球囊，由于球囊本体上设置有多组切割刀组，每组刀组中的切割刀片均位于同一圆周上并且沿着球囊本体的圆周方向延伸，因此在球囊收缩状态下容易通过迂曲的血管到达血管狭窄部位，在球囊膨胀状态下进行切割时还不容易发生受力不均匀的情况，能够更好地对具有钙化斑块血管狭窄部位进行切割和扩张。另外，球囊本体上还设置有载药区，该载药区能够用于涂布药物，因此能够在扩张血管的同时完成给药操作。According to the drug-loaded cutting balloon provided by the present invention, since the balloon body is provided with multiple groups of cutting knife groups, the cutting blades in each group of knife groups are all located on the same circumference and extend along the circumferential direction of the balloon body, so in In the state of balloon contraction, it is easy to reach the stenotic part of the blood vessel through the tortuous blood vessel. When the balloon is inflated, it is not easy to be unevenly stressed, and it can better cut and repair the stenotic part of the blood vessel with calcified plaque. expansion. In addition, the balloon body is also provided with a drug-loaded area, and the drug-loaded area can be used to coat drugs, so that the drug delivery operation can be completed while dilating blood vessels.
附图说明Description of drawings
图1是本发明的载药切割球囊膨胀状态下的结构示意图；Fig. 1 is a schematic structural view of a drug-loaded cutting balloon of the present invention in an inflated state;
图2是图1的载药切割球囊的A-A剖视图；Fig. 2 is an A-A sectional view of the drug-loaded cutting balloon of Fig. 1;
图3是本发明的载药切割球囊收缩状态下的侧视图。Fig. 3 is a side view of the drug-loaded cutting balloon of the present invention in a contracted state.
具体实施方式detailed description
以下结合附图以及实施例来说明本发明的具体实施方式。The specific implementation manners of the present invention will be described below in conjunction with the drawings and embodiments.
<实施例><Example>
图1是本发明的载药切割球囊膨胀状态下的结构示意图。Fig. 1 is a schematic structural view of the drug-loaded cutting balloon of the present invention in an inflated state.
如图1所示，本发明的载药切割球囊10包括：球囊本体11以及多组切割刀组12。在本实施例中，切割刀组12的数量为五组。As shown in FIG. 1 , the drug-loaded cutting balloon 10 of the present invention includes: a balloon body 11 and multiple sets of cutting knife sets 12 . In this embodiment, the number of cutting knife sets 12 is five.
球囊本体11呈空心的椭圆球状，其主要采用具有一定弹性的医用高分子材料制成(例如聚乙烯、聚氨酯、聚酰胺和尼龙等)。该球囊本体11的一个端部为盲端，另一个端部上具有导管连接部111，该导管连接部111呈管状并且与球囊本体11的内部连通，用于连接导管。导管与外部设备连接，将球囊本体11送往病变部位后即可通过该导管向球囊本体11内部通入液体，使球囊本体11呈现如图1所示的膨胀状态。The balloon body 11 is in the shape of a hollow ellipse, and is mainly made of medical polymer materials with certain elasticity (such as polyethylene, polyurethane, polyamide and nylon, etc.). One end of the balloon body 11 is a blind end, and the other end has a catheter connection portion 111 , which is tubular and communicates with the interior of the balloon body 11 for connecting a catheter. The catheter is connected with external equipment, and after the balloon body 11 is sent to the lesion, liquid can be passed into the inside of the balloon body 11 through the catheter, so that the balloon body 11 presents an inflated state as shown in FIG. 1 .
图2是图1的载药切割球囊的A-A剖视图。Fig. 2 is an A-A sectional view of the drug-loaded cutting balloon of Fig. 1 .
如图1及图2所示，球囊本体11上具有多个载药区112。这些载药区112采用比球囊本体11的其他区域弹性更好的医用高分子材料(例如聚氯乙烯)制成，使得载药区域112的柔性大于球囊本体11的其他区域，因而在球囊本体11膨胀时，这些载药区112均凸出球囊本体11表面。在本实施例中，载药区112一共有五组，每组包括三个载药区112，同一组的载药区112位于同一圆周上。As shown in FIG. 1 and FIG. 2 , the balloon body 11 has a plurality of drug-loaded regions 112 . These drug-loaded areas 112 are made of medical polymer materials (such as polyvinyl chloride) with better elasticity than other areas of the balloon body 11, so that the flexibility of the drug-loaded area 112 is greater than that of other areas of the balloon body 11. When the balloon body 11 is inflated, these drug-loaded areas 112 protrude from the surface of the balloon body 11 . In this embodiment, there are five groups of drug-loaded regions 112, each group includes three drug-loaded regions 112, and the drug-loaded regions 112 of the same group are located on the same circumference.
载药区112的表面均具有载药涂层，该载药涂层采用生物相容性良好的表面活性剂(例如聚山梨醇酯、聚乙二醇、聚甘油酯、聚硬脂酸酯)涂布形成。由于治疗血管病变的药物多为亲脂性药物，因此这种由表面活性剂形成的载药涂层能够在涂布药物时对药物进行吸附，到达病变部位后又能够对药物进行释放。另外，载药涂层的厚度及药物涂布量均根据实际给药需求确定，在本实施例中该载药涂层的厚度为15μm。The surface of the drug-loaded area 112 has a drug-loaded coating, and the drug-loaded coating adopts a biocompatible surfactant (such as polysorbate, polyethylene glycol, polyglycerol ester, polystearate) coating formation. Since the drugs for treating vascular lesions are mostly lipophilic drugs, the drug-loaded coating formed by the surfactant can absorb the drugs when coating the drugs, and release the drugs after reaching the lesion site. In addition, the thickness of the drug-loaded coating and the coating amount of the drug are determined according to the actual drug administration requirements. In this embodiment, the thickness of the drug-loaded coating is 15 μm.
图3是本发明的载药切割球囊收缩状态下的侧视图。Fig. 3 is a side view of the drug-loaded cutting balloon of the present invention in a contracted state.
如图3所示，在球囊本体11收缩时，载药区112凹陷在球囊本体11的内部，这样就使球囊本体11在血管中移动时载药区112不会暴露在表面，因此载药区112上的载药涂层及药物不会被血液冲走。As shown in Figure 3, when the balloon body 11 contracts, the drug-loaded region 112 is recessed inside the balloon body 11, so that the drug-loaded region 112 will not be exposed on the surface when the balloon body 11 moves in the blood vessel, so the drug-loaded The drug-loaded coating and drug on the drug zone 112 will not be washed away by blood.
如图1及图2所示，每组切割刀组12均含有三个切割刀片121，每个切割刀片121均沿球囊本体11的圆周方向延伸，呈略带弧形的形状。每组切割刀组12中的切割刀片121均设置在同一圆周上，该圆周上还设置有一组载药区112。其中，每个载药区112分别位于该切割刀组12的三个切割刀片121之间，也就是说，在该圆周上，三个载药区112和三个切割刀片121依次交替设置。As shown in FIG. 1 and FIG. 2 , each cutting knife set 12 includes three cutting blades 121 , and each cutting blade 121 extends along the circumferential direction of the balloon body 11 in a slightly arc shape. The cutting blades 121 in each group of cutting blade sets 12 are arranged on the same circumference, and a group of drug-loading regions 112 is also arranged on the circumference. Wherein, each drug-loaded area 112 is respectively located between the three cutting blades 121 of the cutting knife set 12 , that is, on the circumference, three drug-loaded areas 112 and three cutting blades 121 are arranged alternately in sequence.
在本实施例中，每个切割刀片121上均设置有显影环，并且每个切割刀片121的长度均为0.5mm。另外，切割刀片121为金属材料制成，通过胶黏的方式固定在球囊本体11的表面相应位置处。In this embodiment, each cutting blade 121 is provided with a developing ring, and the length of each cutting blade 121 is 0.5 mm. In addition, the cutting blade 121 is made of metal material, and is fixed at a corresponding position on the surface of the balloon body 11 by means of glue.
实施例作用与效果Function and effect of embodiment
根据本实施例提供的载药切割球囊，由于球囊本体上设置有多组切割刀组，每组刀组中的切割刀片均位于同一圆周上并且沿着球囊本体的圆周方向延伸，因此在球囊收缩状态下容易通过迂曲的血管到达血管狭窄部位，在球囊膨胀状态下进行切割时还不容易发生受力不均匀的情况，能够更好地对具有钙化斑块血管狭窄部位进行切割和扩张。According to the drug-loaded cutting balloon provided in this embodiment, since the balloon body is provided with multiple sets of cutting knife sets, the cutting blades in each set of knife sets are located on the same circumference and extend along the circumferential direction of the balloon body. In the state of balloon contraction, it is easy to reach the narrowed part of the blood vessel through the tortuous blood vessel, and it is not easy to experience uneven force when cutting under the state of balloon expansion, which can better cut the narrowed part of the blood vessel with calcified plaque and expansion.
本实施例中，球囊本体上还设置有载药区，该载药区能够用于涂布药物，因此能够在扩张血管的同时完成给药操作。进一步，该载药区的柔性大于球囊本体的其他区域，因而这些载药区在球囊本体收缩时凹陷在球囊本体表面以下，并且在球囊本体膨胀时凸出球囊本体表面，既能够保证移动过程中载药区上的药物不会被血液冲走，又能够在球囊本体膨胀时充分接触病变部位从而进行给药。In this embodiment, the balloon body is also provided with a drug-loaded area, which can be used to coat drugs, so that the drug delivery operation can be completed while dilating blood vessels. Further, the drug-loaded area is more flexible than other areas of the balloon body, so these drug-loaded areas are recessed below the surface of the balloon body when the balloon body is deflated, and protrude from the surface of the balloon body when the balloon body is inflated. It can ensure that the drug on the drug-loading area will not be washed away by the blood during the moving process, and can fully contact the lesion when the balloon body is inflated so as to administer the drug.
本实施例中，每组切割刀组的切割刀片均位于同一圆周上，载药区位于切割刀片之间并且和切割刀片同样位于同一圆周上，使得球囊本体膨胀后，切割刀片切割病变部位的同时载药区能够对切割后的部位准确地进行给药，使药物充分作用于病变部位。In this embodiment, the cutting blades of each group of cutting blades are located on the same circumference, and the drug-loaded area is located between the cutting blades and is also located on the same circumference as the cutting blades, so that after the balloon body is inflated, the cutting blades cut the lesion. At the same time, the drug-loading area can accurately administer the drug to the cut part, so that the drug can fully act on the diseased part.
另外，本实施例的切割刀片上还设置有显影环，在介入过程中能够通过显影手段直接确切割刀片的位置，使切割操作的定位更加精确。In addition, the cutting blade in this embodiment is also provided with a developing ring, which can directly determine the position of the cutting blade through developing means during the intervention process, making the positioning of the cutting operation more accurate.
上述实施例仅用于说明本发明的具体实施方式，但本发明的载药切割球囊不仅限于上述实施例描述的范围。The above examples are only used to illustrate the specific implementation of the present invention, but the drug-loaded cutting balloon of the present invention is not limited to the scope described in the above examples.
在上述实施例中，球囊本体上具有五组切割刀组，每组切割刀组包括三个切割刀片，但在本发明中该切割刀组的数量也可以根据病变血管的长度不同而设置，每组切割刀组也可以包括更多的切割刀片。例如，针对短病变血管设置三组切割刀组，或者针对长病变血管设置六组及更多的切割刀组。In the above-mentioned embodiment, there are five groups of cutting blades on the balloon body, and each group of cutting blades includes three cutting blades, but in the present invention, the number of the cutting blades can also be set according to the length of diseased blood vessels. Each set of cutting blades can also include more cutting blades. For example, three sets of cutting knife groups are set for short diseased blood vessels, or six or more cutting knife sets are set for long diseased blood vessels.
在上述实施例中，载药区位于切割刀片之间并且和切割刀片同样位于同一圆周上，但在本发明中，该载药区也可以不设置在切割刀片之间，例如在轴向方向上交替设置。In the above-mentioned embodiments, the drug-loaded area is located between the cutting blades and is located on the same circumference as the cutting blades, but in the present invention, the drug-loaded area may not be arranged between the cutting blades, for example, in the axial direction Alternate settings.
另外，在上述实施例中，切割刀片的长度为0.5mm，载药涂层的厚度为15μm，但在本发明中，切割刀片也可以采用不超过1mm的其他长度，载药涂层的厚度可以为1μm～30μm之间的任意厚度。In addition, in the above-mentioned embodiment, the length of the cutting blade is 0.5 mm, and the thickness of the drug-loaded coating is 15 μm, but in the present invention, the cutting blade can also adopt other lengths not exceeding 1 mm, and the thickness of the drug-loaded coating can be Any thickness between 1 μm and 30 μm.
Claims (7)
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| CN110115610A (en) * | 2019-02-02 | 2019-08-13 | 张嘉 | A kind of orthopaedics sacculus and orthopaedics balloon apparatus with spinous process |
| CN110507385A (en) * | 2019-09-04 | 2019-11-29 | 肖平喜 | A mosaic dilation balloon |
| CN112263773A (en) * | 2020-11-18 | 2021-01-26 | 上海翰凌医疗器械有限公司 | Cutting type balloon dilatation device |
| CN115153712A (en) * | 2022-06-27 | 2022-10-11 | 苏州贝莱弗医疗科技有限公司 | High-safety blood vessel saccule blocking first-aid instrument |
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| WO2023087455A1 (en) * | 2021-11-17 | 2023-05-25 | 上海腾复医疗科技有限公司 | Vascular recanalization device |
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| CN112263773A (en) * | 2020-11-18 | 2021-01-26 | 上海翰凌医疗器械有限公司 | Cutting type balloon dilatation device |
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| CN115153712A (en) * | 2022-06-27 | 2022-10-11 | 苏州贝莱弗医疗科技有限公司 | High-safety blood vessel saccule blocking first-aid instrument |
| CN118078382A (en) * | 2024-04-26 | 2024-05-28 | 鼎科医疗技术（苏州）有限公司 | Drug-loaded scored balloon and balloon catheter |
| CN118078382B (en) * | 2024-04-26 | 2024-06-21 | 鼎科医疗技术（苏州）有限公司 | Drug-loaded scored balloon and balloon catheter |
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