CN106621003A - Drug balloon catheter and preparation method and application thereof - Google Patents
Drug balloon catheter and preparation method and application thereof Download PDFInfo
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- CN106621003A CN106621003A CN201610988119.3A CN201610988119A CN106621003A CN 106621003 A CN106621003 A CN 106621003A CN 201610988119 A CN201610988119 A CN 201610988119A CN 106621003 A CN106621003 A CN 106621003A
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- balloon catheter
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- QJJXYPPXXYFBGM-SHYZHZOCSA-N tacrolimus Natural products CO[C@H]1C[C@H](CC[C@@H]1O)C=C(C)[C@H]2OC(=O)[C@H]3CCCCN3C(=O)C(=O)[C@@]4(O)O[C@@H]([C@H](C[C@H]4C)OC)[C@@H](C[C@H](C)CC(=C[C@@H](CC=C)C(=O)C[C@H](O)[C@H]2C)C)OC QJJXYPPXXYFBGM-SHYZHZOCSA-N 0.000 description 1
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Classifications
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0009—Making of catheters or other medical or surgical tubes
-
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/0043—Catheters; Hollow probes characterised by structural features
- A61M25/0045—Catheters; Hollow probes characterised by structural features multi-layered, e.g. coated
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61M—DEVICES FOR INTRODUCING MEDIA INTO, OR ONTO, THE BODY; DEVICES FOR TRANSDUCING BODY MEDIA OR FOR TAKING MEDIA FROM THE BODY; DEVICES FOR PRODUCING OR ENDING SLEEP OR STUPOR
- A61M31/00—Devices for introducing or retaining media, e.g. remedies, in cavities of the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- 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
- A61M25/00—Catheters; Hollow probes
- A61M25/10—Balloon catheters
- A61M2025/1043—Balloon catheters with special features or adapted for special applications
- A61M2025/105—Balloon 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
Landscapes
- Health & Medical Sciences (AREA)
- Life Sciences & Earth Sciences (AREA)
- Heart & Thoracic Surgery (AREA)
- Hematology (AREA)
- Public Health (AREA)
- Anesthesiology (AREA)
- Biomedical Technology (AREA)
- Engineering & Computer Science (AREA)
- Veterinary Medicine (AREA)
- Animal Behavior & Ethology (AREA)
- General Health & Medical Sciences (AREA)
- Pulmonology (AREA)
- Biophysics (AREA)
- Child & Adolescent Psychology (AREA)
- Pharmaceuticals Containing Other Organic And Inorganic Compounds (AREA)
- Medicines That Contain Protein Lipid Enzymes And Other Medicines (AREA)
- Materials For Medical Uses (AREA)
Abstract
The invention provides a drug balloon catheter and a preparation method and application thereof. The drug balloon catheter comprises a balloon, a delivery catheter communicated with the balloon and a drug coating on the surface of the balloon, wherein the drug coating contains an anti-cytotoxic drug or an immunosuppressor drug for treating rheumatic and rheumatoid diseases. The drug coating is the anti-cytotoxic drug or the immunosuppressor drug for treating the rheumatic and rheumatoid diseases so that vascular inflammatory stenosis caused by parts of the rheumatic and rheumatoid diseases can be solved. The drug coating carried by the balloon centrally acts on the periphery of the lesion vessel after the balloon reaches the lesion vessel, accordingly the local drug concentration of a lesion is achieved, further an ideal treating effect is obtained, and meanwhile restenosis is prevented.
Description
Technical field
The invention belongs to technical field of medical instruments, is related to a kind of medicinal balloon catheter and its preparation method and application, especially
It is related to a kind of antirheumatic angiostenosiss medicinal balloon catheter and its preparation method and application.
Background technology
Rheumatism and rheumatoid arthritis (RA) it is a kind of with articular synovitis systematicness rheumatoid vasculitises be characterized
Chronic generalized autoimmune disease, rheumatism is locally or systemically class disease, its pathological change, except relevant muscle is closed
Outside section pathological changes, the inflammation of blood vessel changes, angiostenosiss, and thrombosiss are so that vascular occlusion, blood flow reduction is also a kind of main
Case characteristic.Rheumatism and rheumatoid vasculitis (RV) are a serious complication, sickness rate 1%-5% clinically,
But postmortem research shows up to 25% ratio, is more common in pathomechanism of the course of disease compared with elder, rheumatism and rheumatoid vasculitis
Possibly anti-endotheliocyte body is combined rear activating complement with corresponding endotheliocyte or by mediating the mediation of body dependent cell
Cytotoxicity and cause endothelial cell injury, immune complex activation tube wall, inducing cell release multiple protein enzyme starts solidifying
Blood mechanism, forms thrombosis.Therefore have many rheumatoid factor with high concentration of vasculitic rheumatoid arthritis patients, low complement blood
There are a large amount of immune complexs in disease, cryoglobulinemia and serum.Speed with erythrocyte sedimentation rate with vasculitic patient is more, it is lean
The Novel presentation such as blood, thrombocytosiss and albumin, globulin concentration reduction, while the inflammatory cell leaching of rheumatoid vasculitis
Moisten around blood vessel, Ink vessel transfusing, crust hypertrophy or blood vessel holostrome inflammatory become, and cause luminal stenosis to block, and blood vessel wall cellulose sample becomes
Property even necrosis, Aneurysmformation, Rupture haemorrhag or fibrosiss etc..
Clinically there is patient RV in 10%-15% in Cardiac Involvemant, can invade coronal this sick First presentation more
Small artery, occasionally involves main coronary artery.Its characteristics of lesion is blood vessel wall and circumvascular inflammatory cell infiltration, immune globulin
The white calmness in blood vessel wall;There can be thrombosiss, but exist without atherosclerotic plaque, pathological changes severe patient can cause myocardium stalk
Extremely.It is generally acknowledged that clinically the concurrent angina pectoriss of rheumatoid coronaritises and (or) acute myocardial infarction person is rare.However, one
The Review literature of 169 patient's RA postmortems is disclosed, and coronaritises are with the direct cause of death that various myocardial infarctions are 10 patients
(5.9%).Therefore, coronary artery inflammation is not as expected so rare.The fatal complication of some other cardiovascular of RV
Also include aortitiss, aortic aneurysm and Acute Aortic lobe incompetence, the rupture of Visceral artery tumor is with hemoperitoneum etc..It is true
On, all rheumatic aortitis cases are that the aortic aneurysm in ascending aorta occurs, and with aortic incompetence.RA
Often involve blood vessel, but it is more with tremulous pulse, and there is phlebitis and the less report of venous thrombosis person.Zhang Suping etc. reports 1
RA patient merges Shuan Ce popliteal venous thrombosis, and patient is without operation, wound, long-term bed, varicosis and takes contraceptive etc.
The risk factor of induction venous thrombosis, thus it is speculated that its thrombotic possible cause is that immunoglobulin and complement are in blood vessel
Wall is deposited, and causes endothelial cell damage, causes phlebitis.
Rheumatism and rheumatoid vasculitic stricture disease, including heart and peripheral arterial are due to rheumatism and rheumatoid blood
Around the inflammatory cell infiltration blood vessel of Guan Yan, Ink vessel transfusing crust hypertrophy or blood vessel holostrome inflammatory become, and cause vessel lumen narrow stifled
Plug, such as coronary stricture, cerebrovascular stenosis, carotid artery stenosises, iliac artery be narrow and femoral artery stenosis.
The narrow method of traditional treatment rheumatism and rheumatoid vascular inflammatory is mainly using heavy dose of glucocorticoid
Use in conjunction immunosuppressive drug, including azathioprine (AZA) and cyclophosphamide (CTX).At present mainly by venoclysises or
Oral such medicine carries out systemic administration treatment, but therapeutic effect is undesirable, and the utilization rate of medicine is not high, has particularly been formed
Narrow blood vessel is poor to this systemic drug therapeutic response.The method of stenotic lesion blood vessel Stent Implantation, because of its active rheumatism
Continue to result in restenosis rate very high, long-term effect is not good, make to be faced a difficult selection during the Clinical practice technology.
Therefore, in the art, it is desired to be able to find a kind of rheumatism that can improve long-term effect and rheumatoid blood vessel
Struvite narrow effectively treatment method.
The content of the invention
For the deficiencies in the prior art, it is an object of the invention to provide a kind of medicinal balloon catheter and preparation method thereof and
Using.
It is that, up to this purpose, the present invention is employed the following technical solutions:
On the one hand, the present invention provides a kind of medicinal balloon catheter, and the medicinal balloon catheter is connected including sacculus with sacculus
Delivery conduit and balloon surface medication coat, the medication coat contains the anti-thin for the treatment of rheumatism and atrophic diseases
Cytotoxic drugs or immune suppressant drug.
The medication coat of the present invention is the anti-cell drug toxicity or immunosuppressant for treating rheumatism and atrophic diseases
Medicine, it is possible to resolve part rheumatism and atrophic diseases cause vascular inflammatory narrow, sacculus is reached after lesion vesselses, its carrying
Medication coat concentrate and act on around lesion vesselses, so as to reach pathological changes topical remedy high concentration, and then obtain Preferred effects,
Prevent restenosiss simultaneously.
In the present invention, the anti-cell drug toxicity or immune suppressant drug of the treatment rheumatism and atrophic diseases
In NSAID (non-steroidal anti-inflammatory drug), cyclophosphamide or glucocorticoid any one or at least two combination.
Cytotoxic drug is the medicine that can effectively kill immunocyte and suppress its propagation, and immunosuppressant is to body
The inhibited medicine of immunoreation, (such as T cell and B cell macrophage are thin to suppress cell relevant with immunoreation
Born of the same parents) propagation and function, reduce antibody mediated immunity reaction.This kind of medicine mainly include glucocorticoidss, microbial metabolic products,
Antimetabolite, polyclone and monoclonal anti lymphocyte antibody, the class of alkylating agents 5.Cytotoxic drug of the present invention includes
But it is not limited to cyclophosphamide or chlormethine.
Immunosuppressant of the present invention includes but is not limited to cortisone, prednisone, cyclosporin, fujimycin 506, anti-
Metabolite, such as azathioprine, Ismipur, antilymphocyte globulin, OKT3 (CD 3-resisting monoclonal antibody) or cyclophosphamide
In any one or at least two combination.
In the present invention, the anti-cell drug toxicity or immune suppressant drug of the treatment rheumatism and atrophic diseases
Can be used in combination with its pharmaceutically active auxiliary agent.
Preferably, the pharmaceutically active auxiliary agent selected from anti-proliferative drugs, promote again endothelialization medicine, anti-cell migration medicine or
Any one or at least two medicine activity components in intercellular matrix regulator are used in combination.Can be used for treat rheumatism and
Rheumatism and rheumatoid vasculitises that atrophic diseases cause and the vessel lumen stricture disease that causes, and prevent stenter to implant
The generation of restenosiss phenomenon afterwards.
In the present invention, the drug loading of the medication coat is 10~500 μ g/cm2, such as 12 μ g/cm2、15μg/cm2、
18μg/cm2、20μg/cm2、25μg/cm2、30μg/cm2、40μg/cm2、50μg/cm2、80μg/cm2、100μg/cm2、120μg/
cm2、150μg/cm2、180μg/cm2、200μg/cm2、250μg/cm2、280μg/cm2、300μg/cm2、350μg/cm2、400μg/
cm2、450μg/cm2Or 480 μ g/cm2, preferred 50-200 μ g/cm2, further preferred 80-150 μ g/cm2。
In the present invention, the medication coat includes biostable polymer material, it is preferable that the biological stability
Polymeric material is polylactic acid-polyglycol block polymer, polyethylene glycol caprolactone block polymer or polylactic acid-glycolic
In acetic acid copolymer any one or at least two combination.
Preferably, the thickness of the medication coat is 1~50 μm, such as 2 μm, 5 μm, 8 μm, 10 μm, 13 μm, 15 μm, 18 μ
M, 20 μm, 23 μm, 25 μm, 28 μm, 30 μm, 33 μm, 35 μm, 38 μm, 40 μm, 42 μm, 45 μm or 48 μm, preferred 5-20 μm.
Preferably, in the medication coat medicine percentage by weight be 1~50%, such as 2%, 5%, 8%, 10%,
13%th, 15%, 18%, 20%, 22%, 25%, 28%, 30%, 33%, 35%, 38%, 40%, 42%, 45% or 48%,
It is preferred that 10-20%.
In the present invention, a diameter of 0.8~7.0mm of the sacculus, such as 1mm, 1.5mm, 1.8mm, 2mm, 2.5mm,
2.8mm, 3mm, 3.3mm, 3.5mm, 3.8mm, 4mm, 4.5mm, 4.8mm, 5mm, 5.5mm, 5.8mm, 6mm, 6.3mm, 6.5mm or
6.8mm, the length of sacculus is 8~120mm, such as 9mm, 12mm, 15mm, 20mm, 30mm, 40mm, 50mm, 60mm, 70mm,
80mm, 90mm, 100mm or 110mm.
In the present invention, the sacculus is by selected from polyethylene (PE), polyethylene terephthalate (PET), nylon
(Nylon) any one or at least two material, in Pebax, polyurethane (PU), polypropylene (PP) or latex is made.
On the other hand, the invention provides the preparation method of the medicinal balloon catheter, methods described is:By medicine or medicine
Thing is combined and biostable polymer material mixing, and by spraying or dip-coating even spread to balloon surface the medicine is obtained
Foley's tube;Or first by biostable polymer material by spraying or dip-coating even spread to balloon surface, then will
Medicine or drug regimen adsorb in coating surface, obtain the medicinal balloon catheter.
The medicinal balloon catheter that the present invention is prepared can be used to treat rheumatism and rheumatoid vasculitic angiostenosiss,
Compared with the method for traditional treatment rheumatism and rheumatoid vasculitic angiostenosiss, the medicinal balloon catheter is formed for for it
Narrow vascular treatment effect is good, and administration targeting is good, and utilization ratio of drug is high, and persistence is strong, reduces continuing because of active rheumatism
The high risk of caused restenosis rate, medium-long term effect is good, with good clinical and commercial promise.
On the other hand, the invention provides described medicinal balloon catheter answering in antirheumatic angiostenosiss apparatus
With.The medicinal balloon catheter of the present invention can play it as the therapeutic device or medical material for antirheumatic angiostenosiss
Antirheumatic and prevent the dual function of angiostenosiss.
Relative to prior art, the invention has the advantages that:
The medication coat of the present invention is the anti-cell drug toxicity or immunosuppressant for treating rheumatism and atrophic diseases
Medicine, it is possible to resolve part rheumatism and atrophic diseases cause vascular inflammatory narrow, sacculus is reached after lesion vesselses, its carrying
Medication coat concentrate and act on around lesion vesselses, so as to reach pathological changes topical remedy high concentration, and then obtain Preferred effects,
Prevent restenosiss simultaneously.
Specific embodiment
Technical scheme is further illustrated below by specific embodiment.Those skilled in the art should be bright
, the embodiment be only to aid in understand the present invention, be not construed as to the present invention concrete restriction.
Embodiment 1
In the present embodiment, medicinal balloon catheter includes the delivery conduit that connects with sacculus of sacculus and balloon surface
Medication coat, medication coat contains cortisone and biostable polymer Poly(D,L-lactide-co-glycolide, its preparation method
For:Medicine and biostable polymer material Poly(D,L-lactide-co-glycolide are dissolved in solvent, mixing is mixed to get
Thing, by the mixture by spraying or dip-coating even spread to balloon surface, after solvent volatilization, medicine stays in balloon surface,
So as to obtain the medicinal balloon catheter.The medication coat gross thickness of the medicinal balloon is 10 μm, total wherein shared by active medicine
Percentage by weight is 10%, a diameter of 2mm of the sacculus, and the length of sacculus is 10mm.
Embodiment 2
In the present embodiment, medicinal balloon catheter includes the delivery conduit that connects with sacculus of sacculus and balloon surface
Medication coat, medication coat contains cyclophosphamide and biostable polymer polylactic acid-polyglycol block polymer, its system
Preparation Method is:Medicine and biostable polymer material are dissolved in solvent, mixture is mixed to get, the mixture is passed through
, to balloon surface, after solvent volatilization, medicine stays in balloon surface, so as to obtain the medicine ball for spraying or dip-coating even spread
Ductus bursae.The medication coat gross thickness of the medicinal balloon is 5 μm, and wherein total weight percent shared by active medicine is 5%, wherein
Total weight percent shared by active medicine is 10%, a diameter of 7mm of the sacculus, and the length of sacculus is 100mm.
Embodiment 3
In the present embodiment, medicinal balloon catheter includes the delivery conduit that connects with sacculus of sacculus and balloon surface
Medication coat, medication coat contains the mixture and biostable polymer polylactic acid of cyclophosphamide and prednisone-poly- second
Diol block polymer, its preparation method is:Pharmaceutical composition and biostable polymer material are dissolved in solvent, are mixed
Mixture is obtained, by the mixture by spraying or dip-coating even spread to balloon surface, after solvent volatilization, medicine stays in ball
Capsule surface, so as to obtain the medicinal balloon catheter.The medication coat gross thickness of the medicinal balloon is 20 μm, wherein active medicine
Shared total weight percent be 1%, wherein total weight percent shared by active medicine be 10%, the sacculus it is a diameter of
0.8mm, the length of sacculus is 8mm.
Embodiment 4
In the present embodiment, medicinal balloon catheter includes the delivery conduit that connects with sacculus of sacculus and balloon surface
Medication coat, medication coat contains azathioprine and biostable polymer polyethylene glycol caprolactone block polymer,
Its preparation method is:Medicine and biostable polymer material are dissolved in solvent, mixture are mixed to get, by the mixture
By spraying or dip-coating even spread to balloon surface, after solvent volatilization, medicine stays in balloon surface, so as to obtain the medicine
Thing foley's tube.The medication coat gross thickness of the medicinal balloon is 30 μm, and wherein total weight percent shared by active medicine is
50%, wherein total weight percent shared by active medicine is 10%, a diameter of 4mm of the sacculus, and the length of sacculus is
120mm。
Embodiment 5
In the present embodiment, medicinal balloon catheter includes the delivery conduit that connects with sacculus of sacculus and balloon surface
Medication coat, medication coat contains the mixture and biostable polymer polyethylene glycol of cyclophosphamide and prednisone
Caprolactone block polymer, its preparation method is:By pharmaceutical composition and biostable polymer material polyethylene glycol
Lactone block polymer is dissolved in solvent, is mixed to get mixture, by the mixture by spraying or dip-coating even spread to ball
Capsule surface, after solvent volatilization, medicine stays in balloon surface, so as to obtain the medicinal balloon catheter.The medicine of the medicinal balloon
Thing total coating thickness is 10 μm, and wherein total weight percent shared by active medicine is 10%, wherein gross weight shared by active medicine
Percentage ratio is 20%, a diameter of 2mm of the sacculus, and the length of sacculus is 20mm.
Medicinal balloon catheter prepared by embodiment of the present invention 1-5 is used to treat rheumatism and rheumatoid vasculitic is narrow
When, its therapeutic effect is good, and administration targeting is good, and utilization ratio of drug is high, and persistence is strong, can reduce continuing to result in because of active rheumatism
The high risk of restenosis rate, medium-long term effect is good, with good clinical and commercial promise.
Applicant states that the present invention illustrates medicinal balloon catheter of the present invention and preparation method thereof by above-described embodiment
And application, but the invention is not limited in above-described embodiment, that is, do not mean that the present invention has to rely on above-described embodiment ability real
Apply.Person of ordinary skill in the field it will be clearly understood that any improvement in the present invention, to the equivalent of each raw material of product of the present invention
Replacement and addition, the selection of concrete mode of auxiliary element etc., within the scope of all falling within protection scope of the present invention and disclosure.
Claims (10)
1. a kind of medicinal balloon catheter, it is characterised in that the medicinal balloon catheter includes that the conveying that sacculus is connected with sacculus is led
The medication coat of pipe and balloon surface, the medication coat contains the anti-cell toxicity medicine for the treatment of rheumatism and atrophic diseases
Thing or immune suppressant drug.
2. medicinal balloon catheter according to claim 1, it is characterised in that the treatment rheumatism and atrophic diseases
Anti-cell drug toxicity or immune suppressant drug are any one in NSAID (non-steroidal anti-inflammatory drug), cyclophosphamide or glucocorticoid
Kind or at least two combination.
3. medicinal balloon catheter according to claim 1 and 2, it is characterised in that the treatment rheumatism and rheumatoid disease
The anti-cell drug toxicity or immune suppressant drug of disease is used in combination with its pharmaceutically active auxiliary agent;
Preferably, the pharmaceutically active auxiliary agent is selected from anti-proliferative drugs, promotees endothelialization medicine, anti-cell migration medicine or cell again
Between any one or at least two medicine activity components in substrate regulator.
4. the medicinal balloon catheter according to any one of claim 1-3, it is characterised in that the load medicine of the medication coat
Measure as 10~500 μ g/cm2, preferred 50-200 μ g/cm2, further preferred 80-150 μ g/cm2。
5. the medicinal balloon catheter according to any one of claim 1-4, it is characterised in that the medication coat includes life
Thing stable polymers material;
Preferably, the biostable polymer material be polylactic acid-polyglycol block polymer, polyethylene glycol
In lactone block polymer or Poly(D,L-lactide-co-glycolide any one or at least two combination.
6. the medicinal balloon catheter according to any one of claim 1-5, it is characterised in that the thickness of the medication coat
For 1~50 μm, preferred 5-20 μm;
Preferably, the percentage by weight of medicine is 1~50% in the medication coat, preferred 10-20%.
7. the medicinal balloon catheter according to any one of claim 1-6, it is characterised in that the sacculus it is a diameter of
0.8~7.0mm, the length of sacculus is 8~120mm.
8. the medicinal balloon catheter according to any one of claim 1-7, it is characterised in that the sacculus is by selected from poly- second
Any one in alkene, polyethylene terephthalate, nylon, Pebax, polyurethane, polypropylene or latex or at least two
Material make.
9. the preparation method of the medicinal balloon catheter according to any one of claim 1-6, it is characterised in that methods described
For:By medicine or drug regimen and biostable polymer material mixing, by spraying or dip-coating even spread to sacculus table
Face obtains the medicinal balloon catheter;Or first by biostable polymer material by spraying or dip-coating even spread to ball
Capsule surface, then adsorbs medicine or drug regimen in coating surface, obtains the medicinal balloon catheter.
10. the medicinal balloon catheter according to any one of claim 1-7 in antirheumatic angiostenosiss apparatus should
With.
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