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CN209137002U - A kind of medicinal balloon - Google Patents

A kind of medicinal balloon Download PDF

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Publication number
CN209137002U
CN209137002U CN201820640738.8U CN201820640738U CN209137002U CN 209137002 U CN209137002 U CN 209137002U CN 201820640738 U CN201820640738 U CN 201820640738U CN 209137002 U CN209137002 U CN 209137002U
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CN
China
Prior art keywords
balloon
coating
sacculus
middle section
proximal end
Prior art date
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Active
Application number
CN201820640738.8U
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Chinese (zh)
Inventor
祁勇翔
罗雷
霍勇
聂芳芳
唐乃杰
缪永生
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.)
Shanghai Pulse Medical Equipment Co Ltd
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Shanghai Pulse Medical Equipment Co Ltd
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Priority to CN201820640738.8U priority Critical patent/CN209137002U/en
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    • 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
    • A61M25/104Balloon catheters used for angioplasty
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L29/00Materials for catheters, medical tubing, cannulae, or endoscopes or for coating catheters
    • A61L29/14Materials characterised by their function or physical properties, e.g. lubricating compositions
    • A61L29/16Biologically active materials, e.g. therapeutic substances
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS 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
    • A61F2/00Filters 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
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/86Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
    • A61F2/90Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
    • A61L2300/00Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
    • A61L2300/40Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
    • A61L2300/416Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
    • 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
    • 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
    • A61M2025/1075Balloon catheters with special features or adapted for special applications having a balloon composed of several layers, e.g. by coating or embedding

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  • Health & Medical Sciences (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Veterinary Medicine (AREA)
  • Public Health (AREA)
  • Heart & Thoracic Surgery (AREA)
  • General Health & Medical Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • Engineering & Computer Science (AREA)
  • Hematology (AREA)
  • Anesthesiology (AREA)
  • Pulmonology (AREA)
  • Biophysics (AREA)
  • Child & Adolescent Psychology (AREA)
  • Vascular Medicine (AREA)
  • Chemical & Material Sciences (AREA)
  • Medicinal Chemistry (AREA)
  • Molecular Biology (AREA)
  • Epidemiology (AREA)
  • Media Introduction/Drainage Providing Device (AREA)

Abstract

The utility model discloses a kind of medicinal balloons, and including sacculus and positioned at the medication coat of the balloon surface, the medication coat includes drug and excipient;The medication coat includes proximal end coating, middle section coating and distal end coating, the load medicine density for carrying medicine density and being greater than the middle section coating of one in the proximal end coating and the distal end coating, the load medicine density for carrying medicine density and being not less than the middle section coating of another one.When treating stent restenosis lesion, pressurising is carried out for lesion characteristic selection medicinal balloon, medicinal balloon plays a supportive role, the big coating part for carrying medicine density is adjacent to the Serious Stenosis lesion of proximal end or distal end, selectivity improves medicament contg, the stenosis rate in serious change region is reduced, while reducing the total drug content of whole section of lesion, reduces body drug toxicity and adverse reaction.

Description

A kind of medicinal balloon
Technical field
The utility model relates to the field of medical instrument technology, narrow again in bracket for treating more specifically to one kind Narrow medicinal balloon.
Background technique
Cardiovascular and cerebrovascular disease has become the big cause of the death that beats the world.Currently, being directed to the treatment method of ischemic heart disease There are mainly three types of: using the Primary Care of drug, the operative treatment of progress coronary artery bypass grafting, by being placed in coronary artery bracket etc. to solve Except the interventional therapy of coronary stenosis.Above-mentioned several treatment methods all achieve apparent effect in terms for the treatment of coronary artery stenosis Fruit, but respectively there are still some significant problems.
Wherein, percutaneous transluminal coronary stent implantation is that support system is transported to target area, sacculus by way of puncturing intervention Expansion release bracket, struts stenotic lesion blood vessel, restores blood supply, treat ischemic heart disease.However bracket is chronically at human body It is interior, body can be stimulated to generate immunological rejection, smooth muscle cell hyperplasia causes intimal thickening, causes lumen to be lost, drop Low lumen patency rate, and then blood supply is influenced, threaten the life and health safety of patient.For this purpose, being directed to intrastent restenotic lesions, need Secondary intervention being carried out to patient to perform the operation, supporting restenotic lesions blood vessel again, recovery blood flow is unimpeded, saves patient vitals.
At present clinically for stent restenosis lesion therapeutic modality mainly include traditional PTA sacculus, intravascular stent and The modes such as medicinal balloon.
Medicinal balloon covers the drug for inhibiting smooth muscle cell hyperplasia on the surface of traditional PTA sacculus, drop Low restenosis incidence, but current medicinal balloon is too low for intrastent restenotic lesions administration medicine content, then to smooth The inhibiting effect of myocyte is insufficient, lumen patency rate decline at a specified future date;Medicament contg is excessively high, then the drug total amount of body will cause poison Property reaction.
In conclusion when using medicinal balloon, how more effectively to inhibit bracket close for intrastent restenotic lesions End and/or distal end smooth muscle cell hyperplasia improve lumen patency rate at a specified future date, guarantee therapeutic effect, while reducing whole section of disease The total drug content of change, and then reduce body drug toxicity and adverse reaction, it is that current those skilled in the art are urgently to be solved Problem.
Utility model content
In view of this, the purpose of this utility model is to provide a kind of medicinal balloon for treating in-stent restenosis, the medicine After the structure design of object sacculus can efficiently solve existing medicinal balloon implantation human body, given for intrastent restenotic lesions Medicine, medicament contg is too low, insufficient to the inhibiting effect of smooth muscle cell, lumen patency rate decline at a specified future date;Medicament contg is excessively high, then The problem of drug total amount of body will cause toxic reaction.
In order to achieve the above object, the utility model provides the following technical solutions:
A kind of medicinal balloon, including sacculus and positioned at the medication coat of the balloon surface, the medication coat includes medicine Object and excipient;The medication coat includes proximal end coating, middle section coating and distal end coating, the proximal end coating and the distal end The load medicine density for carrying medicine density and being greater than the middle section coating of one, the load medicine density of another one are not less than the middle section in coating The load medicine density of coating.
Preferably, in said medicine sacculus, the proximal end coating, the middle section coating and the distal end coating order connect It connects, is distributed in the sacculus outer surface.
Preferably, in said medicine sacculus, the drug be taxol, Docetaxel, rapamycin, rapamycin and One or more of its azoles of its derivative, statins, aspirin, warfarin, heparin, low molecular weight heparin and Xi Luo.
Preferably, in said medicine sacculus, the excipient is Iohexol, magnesium stearate, Iopromide, urea, poly- second Glycol, polysorbate, D-sorbite, three hexyl citrate of bytyry, citroflex A-4, organic ester, shellac and One or more of lauric acid.
Preferably, in said medicine sacculus, the medication coat with a thickness of 1-100um.
Preferably, in said medicine sacculus, the medication coat with a thickness of 2-50um.
Preferably, in said medicine sacculus, the sacculus is using nylon, modification of nylon, nylon elastomer and linear low close Spend one or more of polyethylene different materials.
Preferably, in said medicine sacculus, the sacculus includes sequentially connected balloon proximal portion, sacculus middle portion and ball Capsule distal portion, the proximal end coating is located at balloon proximal portion surface, the middle section coating is located at the sacculus middle portion table Face, the distal end coating are located at balloon distal portion surface, and under pressurising state, the balloon proximal portion is remote with the sacculus The diameter of one is greater than the diameter of the sacculus middle portion in end, and the diameter of another one is straight not less than the sacculus middle portion Diameter.
Preferably, in said medicine sacculus, the balloon proximal portion includes sequentially connected balloon proximal portion proximal end, sacculus Close end middle section and balloon proximal portion distal end, the diameter of balloon proximal portion proximal end is by separate balloon proximal portion middle section One end is gradually increased to the other end.
Preferably, in said medicine sacculus, the balloon distal portion includes sequentially connected balloon distal portion proximal end, sacculus Distal portion middle section and balloon distal portion distal end, the diameter of balloon distal portion distal end is by separate balloon distal portion middle section One end is gradually increased to the other end.
Medicinal balloon provided by the utility model includes sacculus and medication coat, and medication coat is coated on balloon surface, packet Include drug and excipient.Wherein, medication coat includes proximal end coating, the middle section coating positioned at sacculus middle section positioned at balloon proximal With the distal end coating for being located at balloon distal.The load medicine for carrying medicine density and being greater than middle section coating of one in proximal end coating and distal end coating Density, the load medicine density for carrying medicine density and being not less than middle section coating of another one.
In intrastent restenotic lesions, the vascular smooth muscle cell curing of mount proximal end and/or distal portions is the most serious, Radial load from blood vessel is maximum.The load of one in medicinal balloon provided by the utility model, proximal end coating and distal end coating Medicine density is greater than the load medicine density of middle section coating, the load medicine density for carrying medicine density and being not less than middle section coating of another one.Thus, root Fed back according to iconography, judge serious restenosis occur in lesion proximal end or distal end one at or two at, select the utility model In medicinal balloon carry out pressurising, emphasis regioselectivity is administered, at the serious change for guaranteeing mount proximal end and/or distal end Medicament contg is relatively higher, more effectively inhibits smooth muscle cell hyperplasia, improves lumen patency rate at a specified future date, guarantees treatment effect Fruit, while the total drug content of whole section of lesion is reduced, and then reduce body drug toxicity and adverse reaction.
Detailed description of the invention
In order to illustrate the embodiment of the utility model or the technical proposal in the existing technology more clearly, below will be to embodiment Or attached drawing needed to be used in the description of the prior art is briefly described, it should be apparent that, the accompanying drawings in the following description is only It is some embodiments of the utility model, for those of ordinary skill in the art, in the premise not made the creative labor Under, it is also possible to obtain other drawings based on these drawings.
Fig. 1 (a)-(b) is the structural schematic diagram of medicinal balloon in the utility model embodiment one and embodiment two respectively;
Fig. 2 (a)-(b) is the structural schematic diagram of medication coat in the utility model embodiment one and embodiment two respectively;
Fig. 3 is the structural schematic diagram of medicinal balloon cross section in the utility model embodiment one and embodiment two;
Fig. 4 (a)-(b) is the structure of intrastent restenotic lesions in the utility model embodiment one and embodiment two respectively Schematic diagram;
Fig. 5 (a)-(b) is in the utility model embodiment one and embodiment two respectively, and medicinal balloon is transported in bracket Structural schematic diagram at restenotic lesions;
Fig. 6 (a)-(b) is the utility model embodiment one and embodiment two respectively, and medicinal balloon is in in-stent restenosis disease Structural schematic diagram at change when pressurising.
It is marked in attached drawing as follows:
Medicinal balloon -1;Intrastent restenotic lesions -2;Sacculus -10;Medication coat -11;Proximal end coating -110;Middle section applies Layer -111;Distal end coating -112;Drug -113;Excipient -114;Intrastent restenotic lesions proximal end -20;In-stent restenosis Lesion middle section -21;Intrastent restenotic lesions distal end -22;The bracket -23 of original implantation.
Specific embodiment
The utility model embodiment discloses a kind of medicinal balloon, more effectively to inhibit mount proximal end and/or distal end flat Sliding myocyte's hyperplasia improves lumen patency rate at a specified future date, guarantees therapeutic effect, while the drug for reducing whole section of lesion always contains Amount, and then reduce body drug toxicity and adverse reaction.
The following will be combined with the drawings in the embodiments of the present invention, carries out the technical scheme in the embodiment of the utility model Clearly and completely describe, it is clear that the described embodiments are only a part of the embodiments of the utility model, rather than whole Embodiment.Based on the embodiments of the present invention, those of ordinary skill in the art are without making creative work Every other embodiment obtained, fall within the protection scope of the utility model.It should be noted that attached drawing be all made of it is very simple The form of change and use non-accurate ratio, only to it is convenient, lucidly aid in illustrating the purpose of the utility model embodiment.
The core concept of the application is to be improved by the structure to medicinal balloon, and different location medication coat is to lesion region Selectivity administration.In use, fed back according to iconography, judge serious restenosis occur in lesion proximal end or distal end one at or At two, select the utility model in medicinal balloon carry out pressurising, to emphasis regioselectivity be administered, guarantee mount proximal end and/ Or the medicament contg at the serious change of distal end is relatively higher, more effectively inhibits smooth muscle cell hyperplasia, improves at a specified future date Lumen patency rate guarantees therapeutic effect, while reducing the total drug content of whole section of lesion, and then reduces body drug toxicity and not Good reaction.
It is illustrated below with two specific embodiments.
Embodiment (one)
Please refer to Fig. 1 (a), 2 (a) and Fig. 3.Fig. 1 (a) is that the structure of medicinal balloon 1 in the utility model embodiment one is shown It is intended to;Fig. 2 (a) is the structural schematic diagram of medication coat 11;Fig. 3 is the structural schematic diagram of 1 cross section of medicinal balloon.The implementation In, medicinal balloon 1 includes sacculus 10 and medication coat 11.
Wherein, medication coat 11 is located at balloon surface, including drug 113 and excipient 114.Medication coat 11 includes proximal end Coating 110, middle section coating 111 and distal end coating 112, and proximal end coating 110, middle section coating 111 and distal end coating 112 are sequentially arranged Cloth connection, is distributed in the outer surface of sacculus 10.The load medicine that load medicine density in proximal end coating 110 is greater than in the coating of middle section 111 is close It spends, the load medicine density for carrying medicine density and being greater than in middle section coating 111 in distal end coating 112.It should be noted that proximal end coating 110 and distal end coating 112 be located at the both ends of middle section coating 111, specific proximal end and distal end only for distinguishing middle section coating 111 Opposite both ends have no the restriction of absolute distant relationships.In this embodiment, the load medicine of proximal end coating 110 and distal end coating 112 Density is all larger than the load medicine density of middle section coating 111, and both specific load medicine density can be equal.It as needed, also include close The load medicine density of end coating 110 and distal end coating 112 is all larger than the load medicine density of middle section coating 111, but the load medicine density of the two It is unequal, to be suitable for the different situation of intrastent restenotic lesions both ends smooth muscle cell proliferation degree.In other embodiments In, proximal end coating 110, middle section coating 111 and distal end coating 112 can also be in unconnected discontinuous structure.
Specifically, sacculus 10 uses nylon elastomer material.As needed, sacculus may be nylon, modification of nylon and One or more of linear low density of polyethylene different materials.
Specifically, drug 113 is rapamycin in medication coat 11.As needed, or taxol, polyenoid are purple In its azoles of China fir alcohol, rapamycin derivative, statins, aspirin, warfarin, heparin, low molecular weight heparin and Xi Luo It is one or more of.
Specifically, excipient 114 is polysorbate in medication coat 11.As needed, or Iohexol, tristearin Sour magnesium, Iopromide, urea, polyethylene glycol, D-sorbite, three hexyl citrate of bytyry, citroflex A-4, One or more of organic ester, shellac and lauric acid
Specifically, the load medicine density of medication coat 11 is 0.1-9.0ug/mm in medication coat 112, preferably 0.5- 5.0ug/mm2, most preferably 2.0-4.0ug/mm2.It should be noted that proximal end coating 110, middle section coating 111 and distal end coating 112 should all meet above-mentioned numberical range, and the load medicine density for carrying medicine density and being greater than in the coating of middle section 111 in proximal end coating 110, The load medicine density for carrying medicine density and being greater than in middle section coating 111 in distal end coating 112
Specifically, in medication coat 11, medication coat 11 with a thickness of 1-100um, preferably 2-50um, most preferably 5- 20um。
Said medicine sacculus 1, medication coat be by drug and one of excipient and tetrahydrofuran, ethyl alcohol and acetonitrile or It is several to be mixed, mixed liquor is coated in balloon surface by way of spraying, dipping, drop, brushing, is obtained by air-drying Medication coat.It can specifically be prepared by following manner.Drug 113 and excipient 114 are mixed with tetrahydrofuran, obtained Mixed liquor.Mixed liquor is coated uniformly on to the surface of sacculus 10 first by way of spraying, carries medicine density by air-drying to obtain Uniform medication coat.Then, one layer of mixed solution is sprayed again in uniform proximal end coating 110 and 112 surface of distal end coating, pass through It crosses to air-dry and obtains the load medicine density that the medicine density of the load in proximal end coating 110 is greater than in middle section coating 111, in distal end coating 112 Carry the medicinal balloon 1 for the load medicine density that medicine density is greater than in middle section coating 111.Finally medicinal balloon 1 fold pressing and be held, taken turns Wide state is in three wings.
Fig. 4 (a) is please referred to, is the structural schematic diagram of intrastent restenotic lesions 2.In bracket caused by the bracket 23 of implantation Restenotic lesions 2 include: intrastent restenotic lesions proximal end 20, intrastent restenotic lesions middle section 21 and in-stent restenosis disease Become distal end 22.Wherein, the smooth muscle cell proliferation of restenotic lesions proximal end 20 and restenotic lesions distal end 22 is more serious, and lumen is logical Smooth rate is lower, and stenosis is bigger.
Fig. 5 (a) is please referred to, is transported to the structure in intrastent restenotic lesions 2 for the medicinal balloon 1 under contraction state Schematic diagram.In target site, it is ensured that under contraction state, proximal end coating 110 is corresponding with restenotic lesions proximal end 20, middle section coating 111 is corresponding with restenotic lesions middle section 21, and distal end coating 112 is corresponding with restenotic lesions distal end 22.
Fig. 6 (a) is please referred to, to make it support the structural representation of intrastent restenotic lesions 2 to 1 pressurising of medicinal balloon Figure.When to 1 pressurising of medicinal balloon, the amount for the drug 113 that proximal end coating 110 discharges when expanding to lesion proximal end 20 is bigger, Has the function of stronger inhibition smooth muscle cell proliferation.After the completion of supporting and discharging drug, to 1 pressure release of medicinal balloon, by it It withdraws from external.
Embodiment (two)
Please refer to Fig. 1 (b), 2 (b) and Fig. 3.Fig. 1 (b) is that the structure of medicinal balloon 1 in the utility model embodiment two is shown It is intended to;Fig. 2 (b) is the structural schematic diagram of medication coat 11;Fig. 3 is the structural schematic diagram of the cross section of medicinal balloon 1.The implementation In example, medicinal balloon 1 includes sacculus 10 and medication coat 11.
Wherein, medication coat 11 is located at balloon surface, including proximal end coating 110, middle section coating 111 and distal end coating 112, And proximal end coating 110, middle section coating 111 and distal end coating 112 are sequentially arranged connection.Medication coat 11 includes drug 113 and assigns Shape agent 114.Load medicine density of the medicine density greater than in the coating of middle section 111, the load in distal end coating 112 are carried in proximal end coating 110 Medicine density is equal to the load medicine density in middle section coating 111.In other embodiments, proximal end coating 110, middle section coating 111 and remote Holding coating 112 can also be in unconnected discontinuous structure.
Specifically, sacculus 10 uses nylon material.As needed, sacculus can also use modification of nylon, nylon elastomer One or more of with linear low density of polyethylene different materials.
Specifically, drug 113 is taxol in medication coat 11.As needed, drug may be Docetaxel, One in rapamycin and its derivative, statins, aspirin, warfarin, heparin, low molecular weight heparin and Xi Luo its azoles Kind is several.
Specifically, excipient 114 is polyethylene glycol in medication coat 11.As needed, excipient may be iodine sea Alcohol, magnesium stearate, Iopromide, urea, polysorbate, D-sorbite, three hexyl citrate of bytyry, acetyl citrate One or more of tributyl, organic ester, shellac and lauric acid.
Specifically, the load medicine density of medication coat 11 is 0.1-9.0ug/mm in medication coat 112, preferably 0.5- 5.0ug/mm2, most preferably 2.0-4.0ug/mm2
Specifically, in medication coat 11, medication coat 11 with a thickness of 1-100um, preferably 2-50um, most preferably 5- 20um。
Said medicine sacculus 1 can specifically be prepared by following manner.By drug 113 and excipient 114 and tetrahydrofuran It is mixed, obtains two kinds of different mixed liquors of medicament contg.Low concentration mixed liquor is uniformly applied first by way of spraying Middle section and the distal surface of sacculus 10 are overlayed on, middle section coating 111 and distal end coating 112 are obtained.It then, will by way of spraying High drug concentration mixed liquor is coated uniformly on the proximal end face of sacculus 10, obtains proximal end coating 110.Next, by medicinal balloon 1 It carries out air-drying processing, obtains the load medicine density that medicine density is greater than in middle section coating 111 of carrying in proximal end coating 110 and applied equal to distal end The medicinal balloon 1 of the load medicine density of 112 kinds of layer.Finally medicinal balloon 1 fold pressing and be held, profile state is in six wings.
Fig. 4 (b) is please referred to, is the structural schematic diagram of intrastent restenotic lesions 2.In bracket caused by the bracket 23 of implantation Restenotic lesions 2 include: intrastent restenotic lesions proximal end 20, intrastent restenotic lesions middle section 21 and in-stent restenosis disease Become distal end 22.Wherein, the smooth muscle cell proliferation of restenotic lesions proximal end 20 is more serious, and lumen patency rate is lower, stenosis It is bigger.
Fig. 5 (b) is please referred to, is transported to the structure in intrastent restenotic lesions 2 for the medicinal balloon 1 under contraction state Schematic diagram.In target site, it is ensured that under contraction state, proximal end coating 110 is corresponding with restenotic lesions proximal end 20, middle section coating 111 is corresponding with restenotic lesions middle section 21, and distal end coating 112 is corresponding with restenotic lesions distal end 22.
Fig. 6 (b) is please referred to, to make it support the structural representation of intrastent restenotic lesions 2 to 1 pressurising of medicinal balloon Figure.When to 1 pressurising of medicinal balloon, the amount for the drug 113 that proximal end coating 110 discharges when expanding to lesion proximal end 20 is bigger, Has the function of stronger inhibition smooth muscle cell proliferation.After the completion of supporting and discharging drug, to 1 pressure release of medicinal balloon, by it It withdraws from external.
In the above embodiments, sacculus includes sequentially connected balloon proximal portion, sacculus middle portion and balloon distal portion, Sacculus includes sequentially connected balloon proximal portion, sacculus middle portion and balloon distal portion, and proximal end coating is located at balloon proximal portion table Face, middle section coating are located at sacculus middle portion surface, distal end coating is located at balloon distal portion surface, and under pressurising state, sacculus is close The diameter of one is greater than the diameter of sacculus middle portion in end and balloon distal portion, and the diameter of another one is not less than in the sacculus The diameter in section portion.Diameter namely both including balloon proximal portion and balloon distal portion is all larger than the diameter of sacculus middle portion, and The diameter of the two is equal;In other implementations, the diameter also including balloon proximal portion and balloon distal portion is all larger than sacculus middle section The diameter in portion, but the diameter of the two is unequal;It further include that the diameter in balloon proximal portion is greater than the diameter of sacculus middle portion, sacculus is remote The diameter of end is equal to the diameter of sacculus middle portion or the diameter in balloon proximal portion is equal to the diameter of sacculus middle portion, sacculus The diameter of distal portion is greater than the diameter of sacculus middle portion, and then can be suitable for intrastent restenotic lesions both ends smooth muscle cell The different situation of hyperplasia degree.According to balloon proximal portion, the difference of sacculus middle portion and balloon distal portion shape, if balloon proximal The diameter in portion, sacculus middle portion or balloon distal portion changes, then the maximum gauge in balloon proximal portion and balloon distal portion is greater than The maximum gauge of sacculus middle portion.Preferably, the company of smooth transition between balloon proximal portion, sacculus middle portion and balloon distal portion It connects.
In intrastent restenotic lesions, the vascular smooth muscle cell curing of mount proximal end and/or distal portions is the most serious, Radial load from blood vessel is maximum.The load of one in medicinal balloon provided by the utility model, proximal end coating and distal end coating Medicine density is greater than the load medicine density of middle section coating, the load medicine density for carrying medicine density and being not less than middle section coating of another one.For right Under the setting pressurising state answered, the diameter of one is greater than the diameter of sacculus middle portion in balloon proximal portion and balloon distal portion, separately The diameter of one is not less than the diameter of the sacculus middle portion.Such as: in proximal end, the medicine density that carries of coating is greater than middle section coating Medicine density is carried, when carrying load medicine density of the medicine density not less than middle section coating of distal end coating, the diameter in balloon proximal portion is greater than ball The diameter of capsule middle portion, the diameter in balloon distal portion are not less than the diameter of sacculus middle portion.And then it on the one hand can be to emphasis area Field selectivity administration guarantees that the medicament contg at the serious change of mount proximal end and/or distal end is relatively higher.On the other hand, it fills Under pressure condition, sacculus is more powerful to the supporting role at proximal end or distal end Serious Stenosis, has stronger inhibition smooth muscle thin The effect of born of the same parents' hyperplasia.
Specifically, balloon proximal portion includes that sequentially connected balloon proximal portion proximal end, balloon proximal portion middle section and sacculus are close The diameter of end distal end, balloon proximal portion proximal end is gradually increased from one end far from balloon proximal portion middle section to the other end.Sacculus The diameter of close end proximal end is from one end far from balloon proximal portion middle section to the other end (namely close to balloon proximal portion middle section One end) it is gradually increased, it is preferred that it is gradually increased to equal with the diameter in balloon proximal portion middle section.Namely balloon proximal portion End diameter is transition, consequently facilitating the movement of intervention sacculus.
Further, the profile of balloon proximal portion proximal end in skew lines shape, sine and cosine is linear, hyperbola, index are linear Or logarithm is one of linear;Balloon proximal portion middle section is cylindrical or conical;The profile of balloon proximal portion distal end is in level One of linear, skew lines shape, sine and cosine be linear, hyperbola, index are linear or logarithm is linear.
Further, sacculus middle portion is cylindrical or conical.
Specifically, balloon distal portion includes that sequentially connected balloon distal portion proximal end, balloon distal portion middle section and sacculus are remote The diameter of end distal end, balloon distal portion distal end is gradually increased from one end far from balloon distal portion middle section to the other end.Also The end diameter for being balloon distal portion 12 is transition, consequently facilitating the movement of intervention sacculus.
Further, balloon distal portion proximal end profile is linear in level, skew lines shape, sine and cosine is linear, hyperbola, refers to The linear or logarithms of number are one of linear;Balloon distal portion middle section is cylindrical or conical;Balloon distal portion distal end profile is in One of skew lines shape, sine and cosine be linear, hyperbola, index are linear or logarithm is linear.
To sum up, the medicinal balloon 1 for the treatment of in-stent restenosis is provided in the utility model including sacculus 10 and is located at ball The medication coat 11 on capsule surface, medication coat 11 include proximal end coating 110, middle section coating 111 and distal end coating 112, all medicines Object coating 11 includes drug 113 and excipient 114, during the load medicine density of one is greater than in proximal end coating 110 and distal end coating 112 Load medicine density in section coating 111, the load medicine density for carrying medicine density and being not less than middle section coating 111 of another one.
The technical solution of the application is designed by structure, processing and the application method to medicinal balloon, anti-according to iconography Feedback, judge serious restenosis occur in lesion proximal end or distal end one at or two at, select the drug ball in the utility model Capsule carries out pressurising, and emphasis regioselectivity is administered, and guarantees the medicament contg phase at the serious change of mount proximal end and/or distal end To higher, more effectively inhibit smooth muscle cell hyperplasia, improves lumen patency rate at a specified future date, guarantee therapeutic effect, drop simultaneously The total drug content of low whole section of lesion, and then reduce body drug toxicity and adverse reaction.
Each embodiment in this specification is described in a progressive manner, the highlights of each of the examples are with other The difference of embodiment, the same or similar parts in each embodiment may refer to each other.
The foregoing description of the disclosed embodiments can be realized professional and technical personnel in the field or using originally practical new Type.Various modifications to these embodiments will be readily apparent to those skilled in the art, and determine herein The General Principle of justice can be realized in other embodiments without departing from the spirit or scope of the present utility model.Cause This, the present invention will not be limited to the embodiments shown herein, and is to fit to and principles disclosed herein The widest scope consistent with features of novelty.

Claims (7)

1. a kind of medicinal balloon, including sacculus and positioned at the medication coat of the balloon surface, the medication coat includes drug And excipient;It is characterized in that, the medication coat includes proximal end coating, middle section coating and distal end coating, the proximal end coating It is greater than the load medicine density of the middle section coating with the load medicine density of one in the distal end coating, the load medicine density of another one is not small In the load medicine density of the middle section coating.
2. medicinal balloon according to claim 1, which is characterized in that the proximal end coating, the middle section coating and described The connection of distal end coating order, is distributed in the sacculus outer surface.
3. medicinal balloon according to claim 2, which is characterized in that the medication coat with a thickness of 1-100um.
4. medicinal balloon according to claim 2, which is characterized in that the medication coat with a thickness of 2-50um.
5. medicinal balloon according to claim 1-4, which is characterized in that the sacculus includes sequentially connected ball Capsule close end, sacculus middle portion and balloon distal portion, the proximal end coating are located at balloon proximal portion surface, the middle section and apply Layer is located at sacculus middle portion surface, the distal end coating is located at balloon distal portion surface, and under pressurising state, described The diameter of one is greater than the diameter of the sacculus middle portion in balloon proximal portion and the balloon distal portion, and the diameter of another one is not Less than the diameter of the sacculus middle portion.
6. medicinal balloon according to claim 5, which is characterized in that the balloon proximal portion includes sequentially connected sacculus Close end proximal end, balloon proximal portion middle section and balloon proximal portion distal end, the diameter of balloon proximal portion proximal end is by far from described The one end in balloon proximal portion middle section is gradually increased to the other end.
7. medicinal balloon according to claim 5, which is characterized in that the balloon distal portion includes sequentially connected sacculus Distal portion proximal end, balloon distal portion middle section and balloon distal portion distal end, the diameter of balloon distal portion distal end is by far from described The one end in balloon distal portion middle section is gradually increased to the other end.
CN201820640738.8U 2018-04-28 2018-04-28 A kind of medicinal balloon Active CN209137002U (en)

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Cited By (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108378964A (en) * 2018-04-28 2018-08-10 上海脉全医疗器械有限公司 A kind of medicinal balloon
CN110882473A (en) * 2019-12-26 2020-03-17 科睿驰(深圳)医疗科技发展有限公司 Medicinal balloon catheter and preparation method thereof
EP4066878A4 (en) * 2019-11-25 2024-01-10 Qiwei Medical Technology (Shenzhen) Co., Ltd Balloon assembly and medical device comprising same

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
CN108378964A (en) * 2018-04-28 2018-08-10 上海脉全医疗器械有限公司 A kind of medicinal balloon
EP4066878A4 (en) * 2019-11-25 2024-01-10 Qiwei Medical Technology (Shenzhen) Co., Ltd Balloon assembly and medical device comprising same
CN110882473A (en) * 2019-12-26 2020-03-17 科睿驰(深圳)医疗科技发展有限公司 Medicinal balloon catheter and preparation method thereof
CN110882473B (en) * 2019-12-26 2022-04-15 科睿驰(深圳)医疗科技发展有限公司 Medicinal balloon catheter and preparation method thereof

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