CN111494785A - Micro-membrane balloon medicine perfusion system in coronary artery and control method - Google Patents

Micro-membrane balloon medicine perfusion system in coronary artery and control method Download PDF

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Publication number
CN111494785A
CN111494785A CN202010426240.3A CN202010426240A CN111494785A CN 111494785 A CN111494785 A CN 111494785A CN 202010426240 A CN202010426240 A CN 202010426240A CN 111494785 A CN111494785 A CN 111494785A
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balloon
drug
membrane
cavity
perfusion
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许丰强
安毅
路军
郭俊杰
胡龙刚
李姗
田惠
孟真
冷敏
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Affiliated Hospital of University of Qingdao
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    • 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
    • A61M31/002—Devices for releasing a drug at a continuous and controlled rate for a prolonged period of time
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02—Prostheses implantable into the body
    • A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
    • A61F2/06—Blood vessels
    • 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
    • A61M2210/00—Anatomical parts of the body
    • A61M2210/12—Blood circulatory system

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Abstract

The invention belongs to the technical field of drug perfusion, and discloses a micro-membrane balloon drug perfusion system in coronary artery and a control method thereof.A charging cavity is arranged between a balloon inner membrane and a balloon middle membrane, and the balloon middle membrane and the balloon outer membrane are drug perfusion cavities; the drug perfusion cavity is connected with a drug delivery rod pipe, and the drug delivery rod pipe is provided with a drug delivery valve; the balloon air cavity inflation hole is arranged on the inflation cavity and is connected with a balloon inflation tube, and a balloon inflation valve is arranged on the balloon inflation tube; the inner side of the balloon inner membrane is provided with a central hollow eccentric pipeline, the outer side of the central hollow eccentric pipeline is provided with a far-end of the central hollow eccentric pipeline, and the right end of the far-end of the central hollow eccentric pipeline is a near-end of the central hollow eccentric pipeline. The invention can ensure the forward blood flow in the coronary artery after the saccule is expanded, realize that the forward blood flow is not blocked, ensure the blood supply of the far segment of the coronary artery, and can realize the purpose of inhibiting the intimal hyperplasia of the blood vessel.

Description

Micro-membrane balloon medicine perfusion system in coronary artery and control method
Technical Field
The invention belongs to the technical field of drug infusion, and particularly relates to a micro-membrane balloon drug infusion system in coronary artery and a control method.
Background
With the change of dietary structure, coronary heart disease has become the most common cardiovascular disease, and becomes one of the first diseases threatening the life safety of people in China. The interventional treatment of coronary heart disease is the most common and effective means at present. The interventional technique is characterized in that the treatment effect and prognosis of coronary heart disease are obviously improved from the initial pure saccule expansion to the implantation of a metal bare stent to the saccule with a drug coating. However, the implantation of drug-coated stents still cannot avoid stenosis caused by intimal hyperplasia. Therefore, the drug coating balloon is derived, and compared with the traditional balloon, the drug carried by the drug balloon can effectively and continuously permeate into the inner wall of the blood vessel, and is used for the dilation treatment of the restenosis in the stent and the simple coronary lesion. However, the current drug-loaded balloon has limited drug loading and can only maintain the release time of about 60 seconds, so the effect of inhibiting hyperplasia of the intima of the blood vessel is limited, and a balloon device which can release the drug for a long time and inhibit the hyperplasia of the blood vessel wall is urgently needed clinically.
In summary, the problems of the prior art are as follows: the existing drug balloon has short drug release time and limited effect on inhibiting hyperplasia of the vascular intima because of limited drug loading.
The difficulty of solving the technical problems is as follows: therefore, the device which can stably cling to the intima of the inner wall of the vascular disease, continuously expand and continuously release the high-concentration medicament for inhibiting the hyperplasia of the intima of the blood vessel is designed at present, and the difficulty lies in that the device does not influence the forward blood flow in the blood vessel after being continuously expanded and attached, thereby ensuring that the far section myocardium of the vascular disease is effectively perfused and myocardial ischemia infarction does not occur.
The significance of solving the technical problems is as follows: the problems are effectively solved, namely the problem that the perfusion device is attached to coronary vessel for a long time to cause pathological changes is solved, so that the medicine for inhibiting the intimal hyperplasia of the blood vessel is effectively and continuously and stably released, and the problem that the long-term intravascular restenosis is caused by implanting the stent in the blood vessel is effectively solved.
Disclosure of Invention
Aiming at the problems in the prior art, the invention provides a drug perfusion system and a control method for a micro-membrane balloon in a coronary artery, aiming at overcoming ischemia caused by the drug balloon, releasing a drug for inhibiting intimal hyperplasia for a long time, expanding a blood vessel and providing a balloon device which has no obvious obstruction to the blood flow before the blood vessel; meanwhile, the method aims to keep high-concentration local drug perfusion for a long time and keep enough drug concentration in the intima region of a treatment part so as to improve the treatment effect and reduce the restenosis after the stent operation.
The invention is realized in this way, a method for controlling perfusion of a drug in a micro-membrane balloon in a coronary artery, which comprises the following steps:
(1) after the coronary stent is implanted into a coronary lesion, the stent is ensured to be fully expanded and attached to the wall;
(2) removing the coronary stent conveying device, reserving a coronary stent guide wire and simultaneously reserving a radial artery puncture sheath;
(3) delivering the balloon to the intravascular stent or the narrow plaque part in the blood vessel along a guide wire;
(4) the balloon inflation tube is externally connected with a pressure pump, and the inner balloon is inflated to fully expand the adherence;
(5) the drug balloon perfusion pipeline is externally connected with a micro pump and is used for continuously pumping the drugs for inhibiting the intimal hyperplasia.
Another objective of the present invention is to provide a coronary artery internal micro-membrane balloon drug infusion system, which is provided with a balloon outer membrane, a balloon middle membrane and a balloon inner membrane; an inflation cavity is arranged between the balloon inner membrane and the balloon middle membrane, the balloon middle membrane and the balloon outer membrane are drug perfusion cavities, and the balloon outer membrane is provided with drug releasing micropores; the drug perfusion cavity is connected with a drug delivery rod pipe, the drug delivery rod pipe is provided with a drug delivery valve, the electronic pressure feedback meter is linked, the electronic feedback meter is connected with a drug micro pump through a closed pipeline, the micro pump is always kept at a constant speed, and the drugs are pumped by the constant pressure pump to ensure effective support of the coronary artery stent and sufficient concentration and speed release of the drugs.
The balloon air cavity inflation hole is arranged on the inflation cavity and is connected with a balloon inflation tube, and a balloon inflation valve is arranged on the balloon inflation tube;
the inner side of the saccule inner membrane is provided with a central hollow eccentric pipeline, the far end of the central hollow eccentric pipeline is the far end of the central hollow eccentric pipeline, and the near end of the central hollow eccentric pipeline is the near end of the central hollow eccentric pipeline.
The innermost layer film and the middle layer film form an inflation cavity, so that gas can enter the inflation cavity, and the expansion of the saccule can be realized; the middle layer membrane and the outermost layer membrane form a drug perfusion cavity, and the outer membrane is provided with drug release micropores to ensure that the drugs are perfused by pressure; wherein, the outermost layer membrane is a microporous membrane to ensure the slow release of the drug. After the saccule is expanded, the air cavity and the medicine cavity are expanded, the central eccentric hollow pipeline is also expanded and the maximum diameter cavity diameter is kept, so that the central eccentric pipeline can still ensure the forward blood flow in the coronary artery after the saccule is expanded, the forward blood flow is not blocked, the blood supply of the far section of the coronary artery is ensured, myocardial ischemia and necrosis are avoided, the continuous extravascular membrane medicine perfusion through the saccule adventitia is realized, and the aim of inhibiting the proliferation of the vascular intima is fulfilled.
Furthermore, a guide wire far-end inlet hole is formed in the near end of the medicine perfusion cavity, and a guide wire near-end outlet is formed in the far end of the medicine perfusion cavity.
The balloon is sent to the intravascular stent or the plaque stenosis in the blood vessel by being provided with a guide wire.
Further, a balloon linear X-ray developing mark is arranged on the central hollow eccentric pipeline and used for displaying the entering depth of the balloon.
Furthermore, when the micro pump pumps the medicine into the medicine saccule, the constant speed of the micro pump is always kept through the electronic pressure feedback meter, and the medicine is pumped by the constant pressure pump for ensuring the effective support of the coronary stent and the sufficient concentration and speed release of the medicine. (the syringe is linked with the input end of the medicine perfusion saccule through a pressure gauge to ensure that the pressure is unchanged, if the pressure is reduced, the micro pump is accelerated through a pressure feedback system to automatically supplement the pressure, so that the constant speed and the constant pressure are realized, the pressure is stabilized at 8kpa, and the effective permeation of the medicine is ensured).
In summary, the advantages and positive effects of the invention are: the invention effectively solves the problem that the perfusion device in the coronary artery is attached to the coronary artery for a long time, and the device does not influence the forward blood flow in the blood vessel after being continuously expanded and attached, thereby ensuring that the far-section myocardium with vascular lesion is effectively perfused and myocardial ischemia infarction does not occur. Thereby effectively, continuously and stably releasing the medicine for inhibiting the intimal hyperplasia of the blood vessel and effectively solving the problem of restenosis in the blood vessel caused by implanting the stent in the blood vessel in a long term. The balloon perfusion system is suitable for coronary vessels with the lumen diameter of more than 2.75 mm. Namely the diameter of the coronary stent is more than 2.75 mm.
Figure BDA0002498770670000031
Drawings
FIG. 1 is a schematic structural diagram of a drug infusion system for a micro-membrane balloon in a coronary artery provided by an embodiment of the invention;
fig. 2 is a schematic diagram of the connection of the electronic pressure feedback meter according to the embodiment of the invention.
In the figure: 1. a drug delivery valve; 2. a balloon inflation valve; 3. a drug delivery rod tube; 4. a balloon inflation tube; 5. a central hollow eccentric conduit proximal end; 6. a balloon outer membrane; 7. nano micropores of the balloon outer membrane; 8. a balloon air cavity inflation hole; 9. an inner balloon membrane; 10. a central hollow eccentric pipe distal end; 11. a distal exit of the guide wire; 12. a balloon middle layer membrane; 13. balloon linear marking; 14. guiding a guide wire to enter the proximal end of the guide wire; 15. An electronic pressure feedback meter; 16. a balloon drug lumen linking end; 17. and a micro pump access end.
Detailed Description
In order to further understand the contents, features and effects of the present invention, the following embodiments are illustrated and described in detail with reference to the accompanying drawings.
In order to solve the problems in the prior art, the invention provides a drug perfusion system for an intra-coronary artery microfilm balloon, which is described in detail below with reference to the accompanying drawings.
As shown in fig. 1 and 2, the intra-coronary artery micro-membrane balloon drug infusion system provided by the embodiment of the invention is provided with a balloon outer membrane 6, a balloon middle membrane 12 and a balloon inner membrane 9; an inflation cavity is arranged between the balloon inner membrane 9 and the balloon middle membrane 12, and the balloon middle membrane 12 and the balloon outer membrane 6 are drug perfusion cavities; the drug perfusion cavity is connected with a drug delivery rod pipe 3, and the drug delivery rod pipe 3 is provided with a drug delivery valve 1.
A balloon air cavity inflation hole 8 is formed in the inflation cavity, the balloon air cavity inflation hole 8 is connected with a balloon inflation tube 4, and a balloon inflation valve 2 is arranged on the balloon inflation tube 4; the left end of the medicine perfusion cavity is provided with a guide wire, the outer side of the guide wire is a guide wire far-end outlet 11, the inner side of the guide wire is a guide wire near-end inlet 14, and the nano micropores 7 of the balloon outer membrane are arranged between the guide wires.
The inner side of the balloon inner membrane 9 is a central hollow eccentric pipeline, the outer side of the central hollow eccentric pipeline is a central hollow eccentric pipeline far-end 10, and the right end of the central hollow eccentric pipeline far-end 10 is a central hollow eccentric pipeline near-end 5.
Preferably, the central hollow eccentric conduit is provided with a balloon linear marker 13.
Preferably, the balloon outer membrane 6 is a nanopore membrane, so that the slow release of the drug is ensured.
The balloon drug cavity link end 16 is linked with the drug delivery rod 3 through the drug delivery valve 1, the micro pump access end 17 is linked with the drug micro pump, and the micro pump is a current clinical conventional application device and does not need to be redesigned. An electronic pressure feedback meter 15 is connected with the balloon drug cavity link 16 and the micro pump access 17.
The working principle of the invention is as follows: after the coronary stent is implanted, a radial artery puncture sheath and a coronary artery internal guide wire are reserved; delivering the balloon to the intravascular stent or the narrow plaque part in the blood vessel along a guide wire; the trachea is externally connected with a pressure pump and is used for the expansion of the inner saccule. The balloon inflation tube 4 is externally connected with a pressure pump and is used for expanding the inner balloon; the drug balloon perfusion pipeline is externally connected with a micro pump and is used for continuously pumping the drugs for inhibiting the intimal hyperplasia.
In the invention, the method for controlling the perfusion of the micro-membrane balloon medicine in the coronary artery comprises the following steps:
(1) after the coronary stent is implanted into a coronary lesion, the stent is ensured to be fully expanded and attached to the wall;
(2) removing the coronary stent conveying device, reserving a coronary stent guide wire and simultaneously reserving a radial artery puncture sheath;
(3) delivering the balloon to the intravascular stent or the narrow plaque part in the blood vessel along a guide wire;
(4) the balloon inflation tube is externally connected with a pressure pump, and the inner balloon is inflated to fully expand the adherence;
(5) the drug balloon perfusion pipeline is externally connected with a micro pump and is used for continuously pumping the drugs for inhibiting the intimal hyperplasia.
The innermost layer film and the middle layer film of the coronary artery inner micro-membrane balloon drug perfusion control method form an inflation cavity to realize balloon expansion; the middle layer membrane and the outermost layer membrane form a drug perfusion cavity, and the outer membrane is provided with drug release micropores.
The outermost membrane is a microporous membrane.
When the micro pump pumps the medicine into the medicine saccule, the constant speed of the micro pump is always kept through the electronic pressure feedback meter, and the medicine is pressed by the constant pressure pump for ensuring the effective support of the coronary stent and the sufficient concentration and speed release of the medicine. (the injector is linked with the input end of the medicine perfusion saccule through the pressure gauge to ensure that the pressure is unchanged, if the pressure is reduced, the micro pump is accelerated through the pressure feedback system to automatically supplement the pressure, the constant speed and the constant pressure are realized, the pressure is stabilized at 8kpa, and the effective permeation of the medicine is ensured.
The above description is only for the preferred embodiment of the present invention, and is not intended to limit the present invention in any way, and all simple modifications, equivalent changes and modifications made to the above embodiment according to the technical spirit of the present invention are within the scope of the technical solution of the present invention.

Claims (10)

1. The coronary artery inner micro-membrane balloon medicine perfusion system is characterized by being provided with a balloon outer membrane, a balloon middle membrane and a balloon inner membrane;
an inflation cavity is arranged between the balloon inner membrane and the balloon middle membrane, the balloon middle membrane and the balloon outer membrane are drug perfusion cavities, and the balloon outer membrane is provided with drug releasing micropores; the drug perfusion cavity is connected with a drug delivery rod pipe, and the drug delivery rod pipe is provided with a drug delivery valve and is connected with the micro pump through the drug delivery valve;
the balloon air cavity inflation hole is arranged on the inflation cavity and is connected with a balloon inflation tube, and a balloon inflation valve is arranged on the balloon inflation tube;
the inner side of the saccule inner membrane is provided with a central hollow eccentric pipeline, the far end of the central hollow eccentric pipeline is the far end of the central hollow eccentric pipeline, and the near end of the central hollow eccentric pipeline is the near end of the central hollow eccentric pipeline.
2. The intracoronary microfilm balloon drug infusion system of claim 1, wherein said drug infusion lumen proximal end is provided with a guidewire proximal end access hole and said drug infusion lumen distal end is a guidewire proximal end exit hole.
3. The intracoronary microfilm balloon drug infusion system of claim 1, wherein a guide wire is provided to deliver the balloon to the stent.
4. The intracoronary microfilm balloon drug infusion system of claim 1, wherein the central hollow eccentric conduit is provided with a balloon linear X-ray visualization marker to indicate the depth of balloon penetration.
5. The intracoronary microfilm balloon drug infusion system of claim 1, wherein the micropump pumps drug into the drug balloon at a constant rate through an electronic pressure feedback gauge.
6. The intracoronary microfilm balloon drug infusion system of claim 1, wherein the balloon drug lumen link is linked to the drug delivery rod through a drug delivery valve, the micropump access is linked to a drug micropump, and the electronic pressure feedback meter is connected to the balloon drug lumen link and the micropump access.
7. A coronary artery inner microfilm balloon drug perfusion control method for operating the coronary artery inner microfilm balloon drug perfusion system according to any one of claims 1-6, characterized in that the coronary artery inner microfilm balloon drug perfusion control method comprises the following steps:
(1) removing the coronary stent conveying device, reserving a coronary stent guide wire and simultaneously reserving a radial artery puncture sheath;
(2) sending the saccule to the bracket along the guide wire;
(3) the balloon inflation tube is externally connected with a pressure pump, and the inner balloon is inflated to fully expand the adherence;
(4) the drug saccule perfusion pipeline is externally connected with a micro pump, and drugs for inhibiting intimal hyperplasia are continuously pumped in.
8. The method for controlling drug infusion into a micro-membranous balloon in a coronary artery according to claim 7, wherein an innermost membrane and a middle membrane of the method for controlling drug infusion into a micro-membranous balloon in a coronary artery form an inflation cavity to realize balloon expansion; the middle layer membrane and the outermost layer membrane form a drug perfusion cavity, and the outer membrane is provided with drug release micropores.
9. The method for intracoronary drug infusion control by a microfilm balloon of claim 7, wherein said outermost membrane is a microporous membrane.
10. The method for controlling drug infusion into a coronary artery by using a microfilm balloon as claimed in claim 7, wherein after said balloon is expanded, the air cavity and the drug cavity are expanded, the central eccentric hollow conduit is also expanded and maintains the maximum diameter of the cavity, thereby achieving the intra-coronary forward blood flow of the central eccentric conduit after the balloon is expanded.
CN202010426240.3A 2020-05-19 2020-05-19 Micro-membrane balloon medicine perfusion system in coronary artery and control method Pending CN111494785A (en)

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