CN113018660A - Microneedle balloon for interventional drug delivery - Google Patents

Microneedle balloon for interventional drug delivery Download PDF

Info

Publication number
CN113018660A
CN113018660A CN202110279738.6A CN202110279738A CN113018660A CN 113018660 A CN113018660 A CN 113018660A CN 202110279738 A CN202110279738 A CN 202110279738A CN 113018660 A CN113018660 A CN 113018660A
Authority
CN
China
Prior art keywords
balloon
drug
micro
interventional
needle
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Pending
Application number
CN202110279738.6A
Other languages
Chinese (zh)
Inventor
申书伟
李丹
郑致远
靳文
邵鹏飞
姚鹏
马礼坤
张志宏
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
University of Science and Technology of China USTC
Original Assignee
University of Science and Technology of China USTC
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by University of Science and Technology of China USTC filed Critical University of Science and Technology of China USTC
Priority to CN202110279738.6A priority Critical patent/CN113018660A/en
Publication of CN113018660A publication Critical patent/CN113018660A/en
Pending legal-status Critical Current

Links

Images

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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/002Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • 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
    • A61M31/00Devices for introducing or retaining media, e.g. remedies, in cavities of the body
    • A61M31/007Injectors for solid bodies, e.g. suppositories
    • 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 relates to a micro-needle balloon for interventional drug delivery, which comprises a guide wire cavity, a balloon dilatation catheter, an dilatation balloon fixed with the balloon dilatation catheter through a balloon connecting neck, a drug-carrying micro-needle and a substrate, wherein the drug-carrying micro-needle is positioned in the substrate and connected with the substrate, and the substrate is connected with the dilatation balloon. The expanded expansion balloon can enable the drug-loaded micro-needle to rapidly penetrate through the wall of a lesion plaque, complete accurate slow-release drug delivery in tissues of the lesion part, shorten the operation time, reduce the damage to blood vessels and further reduce the potential side effect of interventional therapy. The invention realizes the novel micro-needle balloon for interventional drug delivery, and the drug loss is small before the micro-needle balloon is delivered to a target lesion balloon to be expanded through the balloon dilatation catheter; the puncture patch that is used for interveneeing the micropin sacculus of dosing in the inflation process reaches the target of accurate treatment, and the medicine in the medicine carrying micropin can reach the effect of slowly-releasing, and local drug concentration is stable, and long-term effect is raised more.

Description

Microneedle balloon for interventional drug delivery
Technical Field
The invention belongs to the technical field of clinical interventional therapy, and particularly relates to a microneedle balloon for vascular wall drug delivery.
Background
Interventional therapy is a new minimally invasive treatment method for exposing focus without operation between traditional surgical and internal medical treatment, and is a method for treating local disease focus by using special instruments under the guidance of dynamic images (angiography, CT, MR, B-ultrasound) through minimally invasive holes on skin or through original channels of human bodies including blood vessels, intestines and the like by utilizing respiratory and excretory orifices of the human bodies.
Over 30 years, different interventional treatment methods have been developed, and most typically, a balloon dilatation catheter is used to assist in placement of a stent, administration of a local lesion in a blood vessel, and the like.
The only balloons currently available for drug delivery are drug-eluting balloons (DEBs) used in interventional procedures for coronary atherosclerotic heart disease.
The surface of the balloon is coated with the antiproliferative medicine, and the balloon is expanded when the balloon is conveyed to a lesion part, so that the medicine is uniformly adhered to the wall of a blood vessel, neointimal hyperplasia is inhibited, and the aims of relieving angiostenosis and reducing the risk of restenosis are achieved.
However, since the drug of the drug eluting balloon is attached to the surface of the balloon, once the drug comes into contact with blood or other liquid during the operation, the attached drug is dissolved, so that the amount of the drug reaching the lesion site is insufficient.
If the target lesion is located in a twisted or narrow blood vessel, the friction effect during the balloon delivery process can cause large drug unloading loss.
Due to the blocking effect of the blood vessel wall, in order to realize effective release of the medicine into the diseased tissue, the balloon inflation time is generally required to be 60 seconds, which causes a certain degree of ischemia on a far-end blood vessel bed, and if the target blood vessel is large, the blood supply range is wide, and adverse events such as myocardial ischemia and arrhythmia can be induced.
Disclosure of Invention
The invention aims to overcome the defects in the prior art, and provides a novel microneedle balloon for interventional drug delivery.
In order to achieve the purpose, the invention provides a microneedle balloon for interventional drug delivery, which comprises a guide wire cavity, a balloon dilatation catheter, an dilatation balloon fixed with the balloon dilatation catheter through a balloon connecting neck, a drug-carrying microneedle and a substrate, wherein the drug-carrying microneedle is positioned in the substrate and connected with the substrate, and the substrate is connected with the dilatation balloon.
The invention has the beneficial effects that:
the invention aims to provide a novel micro-needle balloon for interventional administration, and the expanded balloon can enable drug-loaded micro-needles to quickly penetrate through the wall of a lesion plaque, complete accurate slow-release administration in tissues of a lesion part, shorten the operation time, reduce the damage to blood vessels and further reduce the potential side effect of interventional treatment.
1. The invention realizes the novel micro-needle balloon for interventional drug delivery, and the drug loss is small before the micro-needle balloon is delivered to a target lesion balloon to be expanded through the balloon dilatation catheter;
2. the patch is penetrated by the micro-needle balloon for intervention administration in the expansion process, so that the aim of accurate treatment is achieved, the medicament in the medicament-carrying micro-needle can achieve the effect of slow release, the local medicament concentration is stable, and the long-term effect is better;
3. compared with the blunt expansion of the saccule in the prior art, the saccule can reduce irregular tearing of the inner membrane and reduce damage;
4. the micro-needle balloon for interventional drug delivery is prepared from biodegradable or compatible materials, the drug loading can be quickly adjusted, the operation time can be shortened in an auxiliary manner, and complications are reduced.
Drawings
FIG. 1 is a schematic structural view of a micro-needle balloon expansion state for interventional drug delivery according to the present invention;
fig. 2 is a schematic view of a drug-loaded microneedle structure of a microneedle balloon for interventional drug delivery according to the present invention;
fig. 3 is a structural schematic diagram of a folded state of a microneedle balloon for interventional drug delivery according to the present invention.
Detailed Description
The present invention will be further described by the following examples, however, the scope of the present invention is not limited to the following examples. Those skilled in the art will appreciate that various changes and modifications may be made to the invention without departing from the spirit and scope of the invention.
Referring to fig. 1, a schematic structural diagram of a microneedle balloon expansion state for interventional drug delivery according to the present invention is shown, wherein:
preferably, including seal wire cavity 1, sacculus expansion pipe 2 and through sacculus connecting neck 3 with the fixed expansion sacculus 4 of sacculus expansion pipe 2, still include medicine carrying micropin 5 and base plate 6, medicine carrying micropin 5 is located in base plate 6 and connect, base plate 6 with expansion sacculus 4 is connected.
Preferably, there are multiple rows of drug-loaded microneedles 5 and multiple substrates 6, and each row of drug-loaded microneedles 5 is distributed in a corresponding substrate 6.
Preferably, please refer to fig. 2 for a schematic structural diagram of a drug-loaded microneedle of a microneedle balloon for interventional drug delivery, and fig. 3 for a schematic structural diagram of a folded state of a microneedle balloon for interventional drug delivery, in which a specific technical scheme of the drug-loaded microneedle 5 with mixed drugs is shown and includes: medicine carrying micropin 5 comprises a cone 5a, a cylinder 5b, cone 5a is located cylinder 5b above and connect, cylinder 5b with base plate 6 is connected. The drug-loaded microneedle 5 is a mixture and mixed in the drug-loaded microneedle 5.
Specifically, each row of drug-loaded microneedles 5 is bonded with a corresponding substrate 6 or is made into an integral structure.
Specifically, each row of drug-loaded microneedles 5 and a corresponding substrate 6 are cast to prepare an integral structure with the help of a template.
Specifically, the bottom of the cone 5a is bonded with the upper part of the cylinder 5b or is made into an integral structure.
Specifically, the cylinder 5b is bonded to the substrate 6 or is made into an integral structure.
Specifically, the drug-loading rate of the drug-loading microneedle 5 is adjusted according to the individual condition of the patient.
Specifically, the bottom surface of the base plate 6 and the surface of the expansion balloon 4 are bonded or cast to prepare an integral structure.
The following is only a specific embodiment in which two rows of drug-loaded microneedles 5 are arranged on the substrate 6:
the micro-needle balloon for interventional drug delivery is fixedly poured with the expansion balloon 5 through a biocompatible bonding material.
The process of interventional drug delivery based on the microneedle balloon for interventional drug delivery of the invention is specifically described as follows:
1. bonding a substrate 6 containing a drug-loaded microneedle 5 of the microneedle balloon for interventional drug delivery and a traditional expansion balloon 4, and folding the substrate to protect the microneedle and reduce the overall diameter;
2. selecting a suitable blood vessel, and puncturing the blood vessel by using a conventional percutaneous puncture (Seldinger) technology;
3. after the puncture is successful, the puncture needle is conveyed into the guide wire cavity 1, the arterial sheath is implanted, and medicines such as heparin and the like are injected through the sheath;
4. selecting proper coronary artery angiography balloon dilatation catheter 2, sending the coronary artery dilatation catheter to the left coronary artery opening and the right coronary artery opening, and selectively injecting contrast agents (iodixanol, iohexol and the like) to enable the coronary arteries to be developed under X-rays;
5. determining the position of a lesion according to the result of radiography, replacing a corresponding guide balloon dilatation catheter 2, sending the guide balloon dilatation catheter into a guide wire cavity 1 to the far section of a target blood vessel, and conveying the micro needle balloon dilatation catheter for interventional administration of the invention to the position of the lesion along the guide wire cavity 1;
6. the micro-needle balloon for interventional drug delivery is expanded by moderate pressure, wherein the balloon connecting neck 3 can limit the expansion range of the balloon, the drug-loaded micro-needle 5 is expanded and punctures the vascular wall of a lesion part, after the drug-loaded micro-needle 5 is inserted into a tissue, the non-sustained-release part of the drug loaded in the drug-loaded micro-needle 5 is quickly dissolved and absorbed, and the sustained-release part of the drug loaded in the drug-loaded micro-needle 5 is remained in the tissue after a period of time;
7. the micro-needle saccule for interventional administration is withdrawn to the outside of the body under the negative pressure state, the coronary angiography is rechecked, if no obvious rupture or damage exists, the operation can be ended, the guide saccule dilating catheter 2 is withdrawn, the arterial sheath is pulled out, the puncture part is packed by sterile gauze in a pressurizing way, if damage such as an obvious interlayer exists after the dilatation, and the stent is implanted as appropriate.
Referring to fig. 3, a schematic diagram of a folded state structure of a microneedle balloon for interventional drug delivery according to the present invention is shown, wherein the microneedle balloon for interventional drug delivery according to the present invention is in a folded shape completed by a folding tool after being fixed, so as to be subsequently delivered to a specific position through a balloon-guiding dilatation catheter 2. After administration is finished, the micro-needle balloon for interventional administration is pulled out, has no sharp objects and toxicity, can be treated as common medical waste, and cannot cause pollution to the environment.
The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the spirit or scope of the invention. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.

Claims (9)

1. A micropin sacculus for intervene is dosed, includes seal wire cavity (1), sacculus expansion pipe (2) and expansion sacculus (4) fixed with sacculus expansion pipe (2) through sacculus connective neck (3), its characterized in that: still include medicine carrying micropin (5) and base plate (6), medicine carrying micropin (5) are located base plate (6) and are connected, base plate (6) with expansion sacculus (4) are connected.
2. A microneedle balloon for interventional drug delivery according to claim 1, characterized in that: the drug-loaded micro-needle has a plurality of rows of drug-loaded micro-needles (5) and a plurality of substrates (6), and each row of drug-loaded micro-needles (5) is distributed in one corresponding substrate (6).
3. A microneedle balloon for interventional drug delivery according to claim 2, characterized in that: each row of drug-loaded micro-needles (5) is bonded with a corresponding substrate (6) or is made into an integral structure.
4. A microneedle balloon for interventional drug delivery according to claim 3, characterized in that: each row of drug-loaded micro-needles (5) and a corresponding substrate (6) are cast with the help of a template to prepare an integrated structure.
5. A microneedle balloon for interventional drug delivery according to claim 1, characterized in that: medicine carrying micro-needle (5) with mix medicine comprises a cone (5a), a cylinder (5b), cone (5a) are located cylinder (5b) above and connect, cylinder (5b) with base plate (6) are connected.
6. A microneedle balloon for interventional drug delivery according to claim 5, characterized in that: the bottom of the cone (5a) and the upper part of the cylinder (5b) are bonded or made into an integral structure.
7. A microneedle balloon for interventional drug delivery according to claim 5, characterized in that: the cylinder (5b) and the substrate (6) are bonded or made into an integral structure.
8. A microneedle balloon for interventional drug delivery according to claim 1, characterized in that: the drug-loading quantity of the drug-loading micro-needle (5) is adjusted according to the individual condition of the patient.
9. A microneedle balloon for interventional drug delivery according to claim 1, characterized in that: the bottom surface of the base plate (6) is bonded with the surface of the expansion balloon (4) or cast to prepare an integral structure.
CN202110279738.6A 2021-03-16 2021-03-16 Microneedle balloon for interventional drug delivery Pending CN113018660A (en)

Priority Applications (1)

Application Number Priority Date Filing Date Title
CN202110279738.6A CN113018660A (en) 2021-03-16 2021-03-16 Microneedle balloon for interventional drug delivery

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
CN202110279738.6A CN113018660A (en) 2021-03-16 2021-03-16 Microneedle balloon for interventional drug delivery

Publications (1)

Publication Number Publication Date
CN113018660A true CN113018660A (en) 2021-06-25

Family

ID=76470829

Family Applications (1)

Application Number Title Priority Date Filing Date
CN202110279738.6A Pending CN113018660A (en) 2021-03-16 2021-03-16 Microneedle balloon for interventional drug delivery

Country Status (1)

Country Link
CN (1) CN113018660A (en)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114010917A (en) * 2021-11-05 2022-02-08 广东博迈医疗科技股份有限公司 Double-medicine administration balloon
CN114225185A (en) * 2021-11-05 2022-03-25 广东博迈医疗科技股份有限公司 Drug delivery balloon and drug delivery device
CN115569294A (en) * 2022-09-02 2023-01-06 杭州矩正医疗科技有限公司 Drug-loaded micro-needle balloon dilatation catheter and preparation method thereof
WO2024045982A1 (en) * 2022-09-02 2024-03-07 杭州矩正医疗科技有限公司 Drug carrier balloon catheter and method for preparing same, balloon catheter system, and method for intravascular in-situ stent generation

Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030065303A1 (en) * 2001-09-28 2003-04-03 Wellman Parris S. Methods and devices for treating diseased blood vessels
US20100228333A1 (en) * 2009-03-04 2010-09-09 William Joseph Drasler Drug eluting surface covering
KR20120019362A (en) * 2010-08-25 2012-03-06 (주)이화바이오메딕스 Balloon catheter provided with film containing and delivering medicine
CN102740800A (en) * 2010-01-29 2012-10-17 爱尔康医药有限公司 Biodegradable protrusions on inflatable device
CN103341231A (en) * 2013-07-17 2013-10-09 成都金赛特生物科技有限公司 Dosing device of visualization intracavity tissue and method of dosing device
CN105451723A (en) * 2013-06-26 2016-03-30 爱荷华大学研究基金会 Oral drug delivery device and methods of using same
CN105873529A (en) * 2013-10-25 2016-08-17 墨卡托医疗***公司 Maintenance of bronchial patency by local delivery of cytotoxic, cytostatic, or anti-neoplastic agent
CN107303406A (en) * 2016-04-21 2017-10-31 青岛智辰生物科技有限公司 A kind of sacculus dilating catheter
CN209790103U (en) * 2018-04-21 2019-12-17 李皇德 Drug release device for blood vessel saccule and saccule support
CN111437005A (en) * 2020-04-24 2020-07-24 中国医学科学院北京协和医院 Guide sheath
CN112336500A (en) * 2020-11-13 2021-02-09 山东瑞安泰医疗技术有限公司 Soluble multi-microneedle drug stent

Patent Citations (11)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US20030065303A1 (en) * 2001-09-28 2003-04-03 Wellman Parris S. Methods and devices for treating diseased blood vessels
US20100228333A1 (en) * 2009-03-04 2010-09-09 William Joseph Drasler Drug eluting surface covering
CN102740800A (en) * 2010-01-29 2012-10-17 爱尔康医药有限公司 Biodegradable protrusions on inflatable device
KR20120019362A (en) * 2010-08-25 2012-03-06 (주)이화바이오메딕스 Balloon catheter provided with film containing and delivering medicine
CN105451723A (en) * 2013-06-26 2016-03-30 爱荷华大学研究基金会 Oral drug delivery device and methods of using same
CN103341231A (en) * 2013-07-17 2013-10-09 成都金赛特生物科技有限公司 Dosing device of visualization intracavity tissue and method of dosing device
CN105873529A (en) * 2013-10-25 2016-08-17 墨卡托医疗***公司 Maintenance of bronchial patency by local delivery of cytotoxic, cytostatic, or anti-neoplastic agent
CN107303406A (en) * 2016-04-21 2017-10-31 青岛智辰生物科技有限公司 A kind of sacculus dilating catheter
CN209790103U (en) * 2018-04-21 2019-12-17 李皇德 Drug release device for blood vessel saccule and saccule support
CN111437005A (en) * 2020-04-24 2020-07-24 中国医学科学院北京协和医院 Guide sheath
CN112336500A (en) * 2020-11-13 2021-02-09 山东瑞安泰医疗技术有限公司 Soluble multi-microneedle drug stent

Cited By (5)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN114010917A (en) * 2021-11-05 2022-02-08 广东博迈医疗科技股份有限公司 Double-medicine administration balloon
CN114225185A (en) * 2021-11-05 2022-03-25 广东博迈医疗科技股份有限公司 Drug delivery balloon and drug delivery device
CN114225185B (en) * 2021-11-05 2024-01-02 广东博迈医疗科技股份有限公司 Administration balloon and administration device
CN115569294A (en) * 2022-09-02 2023-01-06 杭州矩正医疗科技有限公司 Drug-loaded micro-needle balloon dilatation catheter and preparation method thereof
WO2024045982A1 (en) * 2022-09-02 2024-03-07 杭州矩正医疗科技有限公司 Drug carrier balloon catheter and method for preparing same, balloon catheter system, and method for intravascular in-situ stent generation

Similar Documents

Publication Publication Date Title
CN113018660A (en) Microneedle balloon for interventional drug delivery
JP2935522B2 (en) Drug delivery catheter
US6547767B1 (en) Syringe assembly for a catheter
US7150738B2 (en) Substance delivery apparatus and a method of delivering a therapeutic substance to an anatomical passageway
JP4436761B2 (en) Device with expandable potion for drug release
EP1765220B1 (en) Implantable device for drug delivery and improved visibility
ES2300604T3 (en) MEDICINAL DEVICE FOR THE SUPPLY OF MEDICINAL PRODUCT.
US8162880B2 (en) Delivery of therapeutic and marking substance through intra lumen expansion of a delivery device
US7621895B2 (en) Needle array devices and methods
JP2000509623A (en) Combination of coronary stent placement and partial drug administration
KR101230657B1 (en) Balloon catheter provided with film containing and delivering medicine
US20030198798A1 (en) Delivery source of oxygen
CN110548212B (en) Double-balloon catheter with self-perfusion function
CN112401975A (en) Ultrasonic balloon with function of directionally breaking calcified plaque in cavity and preparation method thereof
CN211434679U (en) Medicine-feeding balloon assembly and medical instrument comprising same
US9242005B1 (en) Pro-healing agent formulation compositions, methods and treatments
CN211584834U (en) Double-balloon catheter
CN219517553U (en) Medicine carrying saccule with surface covered with degradable microneedle array
CN219579688U (en) Balloon catheter and conveying pipe for balloon catheter
CN213031623U (en) Balloon component
CN214050144U (en) End medicine coating balloon component and medical instrument comprising same
US20220323725A1 (en) A balloon device and a medical device comprising it
CN117731920A (en) Microneedle balloon interventional device and system
CN117224281A (en) Vascular stent for promoting drug absorption
CN112827055A (en) Medicine-feeding balloon assembly and medical instrument comprising same

Legal Events

Date Code Title Description
PB01 Publication
PB01 Publication
SE01 Entry into force of request for substantive examination
SE01 Entry into force of request for substantive examination
RJ01 Rejection of invention patent application after publication

Application publication date: 20210625

RJ01 Rejection of invention patent application after publication