CN109621162B - Medicine balloon and application method thereof - Google Patents

Medicine balloon and application method thereof Download PDF

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Publication number
CN109621162B
CN109621162B CN201910040327.4A CN201910040327A CN109621162B CN 109621162 B CN109621162 B CN 109621162B CN 201910040327 A CN201910040327 A CN 201910040327A CN 109621162 B CN109621162 B CN 109621162B
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China
Prior art keywords
balloon
drug
medicine
catheter
conical
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CN201910040327.4A
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Chinese (zh)
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CN109621162A (en
Inventor
王君毅
肖国栋
韩巨
王怀明
张晨朝
黄嘉平
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Shanghai Xinwei Medical Technology Co ltd
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Shanghai Xinwei Medical Technology Co ltd
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Publication of CN109621162A publication Critical patent/CN109621162A/en
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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61MDEVICES 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
    • A61M25/00Catheters; Hollow probes
    • A61M25/10Balloon catheters
    • A61M2025/1043Balloon catheters with special features or adapted for special applications
    • A61M2025/105Balloon catheters with special features or adapted for special applications having a balloon suitable for drug delivery, e.g. by using holes for delivery, drug coating or membranes

Abstract

The invention discloses a medicine balloon and a use method thereof, and relates to the field of medical appliances, the medicine balloon comprises a passage system balloon and a medicine conveying balloon, the passage system balloon comprises a cylindrical catheter, a conical balloon and a connecting catheter, two ends of the cylindrical catheter are respectively connected with one conical balloon, the large end of the conical balloon is connected with the cylindrical catheter, and the small end of one conical balloon is connected with the connecting catheter; the access system balloon is of a multi-cavity structure and comprises a central main cavity and a peripheral small cavity, wherein the main cavity and the small cavity extend along the length direction of the access system balloon; the main lumen is used for filling of the access system balloon and the small lumen is used for passage of the drug delivery balloon. The use of the medicine saccule reduces the loss of medicine in the conveying process and improves the actual effective medicine action quantity; meanwhile, the medicine can be released in a targeted way, and the use amount of the medicine is reduced.

Description

Medicine balloon and application method thereof
Technical Field
The invention relates to the field of medical instruments, in particular to a medicine balloon and a using method thereof.
Background
Cardiovascular diseases caused by atherosclerosis, arteritis, etc. are one of the main diseases which endanger human health nowadays. Minimally invasive interventional (implantation) instruments are one of the main means for treating cardiovascular diseases, and have the characteristics of small trauma, remarkable smelling effect, small side effect and the like, and the treatment means have been rapidly developed in recent years. The drug balloon is used as one of minimally invasive implantation technologies, drug is carried on the basis of a delivery system, and the drug is released when the balloon is expanded, so that the drug permeates into vascular tissues, and the effect of treating target lesion blood vessels is achieved. However, the drug balloon cannot release the drug for treating the diseased vessel as slowly as the drug stent for a long time, so the therapeutic effect of the drug balloon is closely related to the drug loading capacity and the drug permeation capacity, and the drug is required to permeate the vascular tissue to the maximum extent at the moment of balloon expansion, otherwise, the therapeutic effect cannot be necessarily achieved in the operation process.
At present, a medicine balloon containing a medicine coating, which is prepared by using an electrostatic self-assembly technology, is available on the market and in the prior patent technology. Chinese patent application CN201410712847.2 relates to a drug-infused balloon, wherein the balloon body has multiple layers of micropores to ensure that the drug is in contact with the vessel wall for a sufficient time; however, the medicine is released to the inner wall of the blood vessel by the way of infiltration, and can not be well adhered to the inner wall of the blood vessel because the medicine is in a solution state, and when the saccule is contracted, blood flow is scoured to take away most of the medicine, so that the actual effective medicine action amount is low. Chinese patent application CN201410289533.6 relates to a drug balloon with a uniform nano-scale microporous structure on the surface and a preparation method thereof, and although the drug loading on the surface of the balloon is improved due to the larger specific surface area, the drug coating is still dissolved in blood due to blood flow scouring during the delivery process.
Accordingly, those skilled in the art have focused their efforts on developing a novel drug balloon with little drug loss during delivery and high actual effective drug action and methods of use thereof.
Disclosure of Invention
In view of the above-mentioned drawbacks of the prior art, the present invention aims to solve the technical problems of large drug loss and low actual effective drug action amount in the conventional drug balloon during the delivery process.
In order to achieve the above purpose, the invention provides a drug balloon and a use method thereof. The drug balloon comprises a passage system balloon and a drug delivery balloon, wherein the passage system balloon comprises a cylindrical catheter, a conical balloon and a connecting catheter, two ends of the cylindrical catheter are respectively connected with one conical balloon, the large end of the conical balloon is connected with the cylindrical catheter, and the small end of one conical balloon is connected with the connecting catheter; the access system balloon is of a multi-cavity structure and comprises a central main cavity and a peripheral small cavity, wherein the main cavity and the small cavity extend along the length direction of the access system balloon; the main lumen is for inflation of the access system balloon and the small lumen is for passage of the drug delivery balloon.
Further, the diameter of the large end of the conical balloon is the same as the diameter of the cylindrical catheter.
Further, the number of small cavities is at least 1.
Further, the connecting catheter is also connected with a medicine pushing device.
Further, the small lumen has a pre-set guide wire therein for providing guidance for the passage of the drug delivery balloon.
Further, the small cavity is a semi-open drug release groove in the cylindrical catheter part, and the small cavity is a closed drug balloon delivery cavity in the conical balloon part and the connecting catheter part.
Further, the number of drug release grooves is equal to the number of drug balloon delivery lumens.
Further, the guide wire has elasticity and flexibility.
Further, the drug balloon is suitable for delivery of solid drugs.
Further, the surface of the drug delivery balloon is provided with a solid drug coating.
Further, the material of the access system balloon is one or more of nylon, polyethylene, polytetrafluoroethylene, polylactide, polyglycolide, polyesteramide or polyurethane.
Further, the use method of the medicine balloon comprises the following steps:
step 1, confirming a lesion position through angiography;
step 2, pre-expanding by using a common balloon to open the lesion position;
step 3, after the access system balloon enters the lesion position, the drug delivery balloon is delivered to the lesion position along the guide wire;
and 4, filling the access system balloon and the drug delivery balloon and tightly attaching the access system balloon and the drug delivery balloon to the blood vessel wall so as to release the drug on the blood vessel wall.
Further, in the step 3, part or all of the guide wires are selected to be used according to actual needs.
Compared with the prior art, the invention has the following advantages:
1. the loss of the drug during the delivery process is reduced. The medicine is adsorbed on the surface of the medicine conveying saccule in a solid form, and after all the medicine conveying saccule reaches the lesion position, the passage system saccule and the medicine conveying saccule are filled so as to be tightly attached to the vascular wall, and the medicine is ensured to be released to the vascular wall. Compared with the traditional medicine balloon, the small cavity of the balloon of the access system is used for conveying the medicine conveying balloon, so that the loss of medicine on the surface of the medicine balloon in the transportation process in the blood vessel is avoided, and the actual effective medicine action quantity is improved.
2. Realizing the targeted release of the medicine. The drug delivery passage can be selectively used, and partial passages are used for lesions with different shapes so as to realize the purpose of targeted drug release, and meanwhile, the use amount of the drug is reduced.
The conception, specific structure, and technical effects of the present invention will be further described with reference to the accompanying drawings to fully understand the objects, features, and effects of the present invention.
Drawings
FIG. 1 is a perspective view of a preferred embodiment of the present invention;
FIG. 2 is a front view of a preferred embodiment of the present invention;
FIG. 3 is a cross-sectional view taken along line A-A of FIG. 2;
FIG. 4 is a right side view of a preferred embodiment of the present invention;
FIG. 5 is a schematic view of the filling state of a preferred embodiment of the present invention;
fig. 6 is a schematic diagram of the targeted release of filling status in accordance with a preferred embodiment of the present invention.
1-cylindrical catheter, 2-conical balloon, 3-connecting catheter, 4-main cavity, 5-drug release slot, 6-drug balloon delivery lumen, 7-guide wire, 8-drug delivery balloon.
Detailed Description
The following description of the preferred embodiments of the present invention refers to the accompanying drawings, which make the technical contents thereof more clear and easy to understand. The present invention may be embodied in many different forms of embodiments and the scope of the present invention is not limited to only the embodiments described herein.
In the drawings, like structural elements are referred to by like reference numerals and components having similar structure or function are referred to by like reference numerals. The dimensions and thickness of each component shown in the drawings are arbitrarily shown, and the present invention is not limited to the dimensions and thickness of each component. The thickness of the components is exaggerated in some places in the drawings for clarity of illustration.
The drug balloon includes a pathway system balloon and a drug delivery balloon.
As shown in fig. 1, the access system balloon comprises a cylindrical catheter 1, a conical balloon 2 and a connecting catheter 3. The diameter of the large end of the conical balloon 2 is the same as that of the cylindrical catheter 1, two ends of the cylindrical catheter 1 are respectively connected with the conical balloon 2, the large end of the conical balloon 2 is connected with the cylindrical catheter 1, and the small end of one conical balloon 2 is connected with the connecting catheter 3. The connecting catheter 3 is also connected to a drug delivery device for applying pressure to deliver the drug to the lesion.
As shown in fig. 3 and 4, the access system balloon is a large balloon catheter having a plurality of drug release grooves 5 or drug balloon delivery lumens 6. The passageway system balloon is of a multi-cavity structure and comprises a central main cavity 4 and a peripheral small cavity, wherein the main cavity 4 and the small cavity extend along the length direction of the passageway system balloon; the small cavity is a semi-open drug release groove 5 at the cylindrical catheter 1 part, and is a closed drug balloon conveying cavity 6 at the conical balloon 2 part and the connecting catheter 3 part. Wherein the main lumen 4 is used for filling of the access system balloon and the small lumen is used for passage of the drug delivery balloon 8.
As shown in fig. 3 and 4, the number of the drug release grooves 5 and the drug balloon delivery cavities 6 is the same, and the number of the drug release grooves 5 or the drug balloon delivery cavities 6 is at least 1.
As shown in fig. 2, the drug delivery slot 5 or the drug balloon delivery lumen 6 has a preset guide wire 7 therein, the guide wire 7 being used to provide guidance for the passage of the drug delivery balloon 8. The guide wire 7 has good elasticity and flexibility.
The drug balloon is suitable for the delivery of solid drugs, which are adsorbed on the surface of the drug delivery balloon 8.
The using method of the medicine saccule comprises the following steps:
step 1, confirming a lesion position through angiography;
step 2, pre-expanding by using a common balloon to open a lesion position;
step 3, after the passage system balloon of the drug balloon enters the lesion position, the drug delivery balloon 8 is delivered to the lesion position along the guide wire 7, and the operation is repeated to guide all the needed drug delivery balloons 8 to reach the lesion position;
step 4, filling and adhering the access system balloon and the drug delivery balloon 8 to the vessel wall (as shown in fig. 5) to release the drug to the vessel wall (as shown in fig. 6).
In the step 3, part or all of the guide wires 7 are selected according to actual needs.
In addition, after confirming the lesion shape, the guide wire 7 preset in the drug delivery channel (namely the drug release groove 5 and the drug balloon delivery cavity 6) can be selectively used, and the part of the guide wire 7 is used for lesions with different shapes, so that the purpose of targeted drug release is realized, and the use amount of the drug is reduced.
The foregoing describes in detail preferred embodiments of the present invention. It should be understood that numerous modifications and variations can be made in accordance with the concepts of the invention without requiring creative effort by one of ordinary skill in the art. Therefore, all technical solutions which can be obtained by logic analysis, reasoning or limited experiments based on the prior art by the person skilled in the art according to the inventive concept shall be within the scope of protection defined by the claims.

Claims (7)

1. The drug balloon is characterized by comprising a passage system balloon and a drug delivery balloon, wherein the passage system balloon comprises a cylindrical catheter, a conical balloon and a connecting catheter, two ends of the cylindrical catheter are respectively connected with one conical balloon, the large end of the conical balloon is connected with the cylindrical catheter, and the small end of one conical balloon is connected with the connecting catheter; the access system balloon is of a multi-cavity structure and comprises a central main cavity and a peripheral small cavity, wherein the main cavity and the small cavity extend along the length direction of the access system balloon; the main lumen is for inflation of the access system balloon and the small lumen is for passage of the drug delivery balloon; the small cavity is a semi-open drug release groove at the cylindrical catheter part, and is a closed drug balloon conveying cavity at the conical balloon part and the connecting catheter part; the drug balloon is suitable for conveying solid drugs, and the solid drugs are adsorbed on the surface of the drug conveying balloon.
2. The drug balloon of claim 1, wherein the diameter of the large end of the conical balloon is the same as the diameter of the cylindrical catheter.
3. The drug balloon of claim 1, wherein the number of small lumens is at least 1.
4. The drug balloon of claim 1, wherein the connecting catheter is further coupled to a drug pushing device.
5. The drug balloon of claim 1, wherein the small lumen has a pre-set guide wire therein for providing guidance for the passage of the drug delivery balloon.
6. The drug balloon of claim 5, wherein the guidewire is elastic and flexible.
7. Use of a drug balloon according to any one of claims 1 to 6 for the manufacture of a drug delivery device.
CN201910040327.4A 2019-01-16 2019-01-16 Medicine balloon and application method thereof Active CN109621162B (en)

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CN109621162B true CN109621162B (en) 2024-01-05

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Families Citing this family (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN110811762A (en) * 2019-08-08 2020-02-21 谱创医疗科技(上海)有限公司 Shock wave enhanced drug delivery catheter
CN111481813B (en) * 2020-06-23 2020-09-29 上海明悦医疗科技有限公司 Drug delivery device, method of manufacturing the same and drug delivery system

Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0551184A1 (en) * 1992-01-08 1993-07-14 Danforth Biomedical, Inc. Guidewire with reversible contact seal for releasable securement to catheter
EP0714640A1 (en) * 1994-11-28 1996-06-05 Advanced Cardiovascular Systems, Inc. System and method for delivering multiple stents
US6027510A (en) * 1997-12-08 2000-02-22 Inflow Dynamics Inc. Stent delivery system
CN106994204A (en) * 2017-03-28 2017-08-01 杭州唯强医疗科技有限公司 Double sacculus medicine-coated balloon dilating catheters
CN209679262U (en) * 2019-01-16 2019-11-26 上海心玮医疗科技有限公司 A kind of medicinal balloon

Patent Citations (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP0551184A1 (en) * 1992-01-08 1993-07-14 Danforth Biomedical, Inc. Guidewire with reversible contact seal for releasable securement to catheter
EP0714640A1 (en) * 1994-11-28 1996-06-05 Advanced Cardiovascular Systems, Inc. System and method for delivering multiple stents
US6027510A (en) * 1997-12-08 2000-02-22 Inflow Dynamics Inc. Stent delivery system
CN106994204A (en) * 2017-03-28 2017-08-01 杭州唯强医疗科技有限公司 Double sacculus medicine-coated balloon dilating catheters
CN209679262U (en) * 2019-01-16 2019-11-26 上海心玮医疗科技有限公司 A kind of medicinal balloon

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Address after: 201201 Room 201, building 4, No. 590, Ruiqing Road, Zhangjiang High Tech Industry East District, Pudong New Area, Shanghai

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Address before: 201201 Room 201, building 4, No. 590, Ruiqing Road, Zhangjiang High Tech Industry East District, Pudong New Area, Shanghai

Applicant before: SHANGHAI HEARTCARE MEDICAL TECHNOLOGY Co.,Ltd.

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