CN102940543A - Combined medical instrument formed by drug coated balloon and stent - Google Patents

Abstract

The invention discloses a combined medical instrument formed by a drug coated balloon and a stent. The combined medical instrument comprises the balloon and the stent, a drug-containing coating is coated outside the balloon, the stent is pressed on the outer wall of the balloon in a held manner, a conduit communicated with the balloon is arranged at one end of the balloon, and the far end of the conduit is connected with a conduit base. By the structure, the novel medical instrument is formed by the drug coated balloon (DCB) carrying drugs and the bare metal stent (BMS), so that the therapeutic effect of low restenosis, similar to that of a drug eluting stent (DES), is achieved through a series of novel design of the balloon and the BMS; meanwhile, late stent thrombosis possibly appearing after the DES is used, the risks brought about by taking anticoagulants for a long period of time, and the financial burden caused by taking the anticoagulants can be avoided; and the novel instrument can be used in a way similar to that of the existing DES, so that the same convenience is achieved.

Description

A kind of medicine carrying sacculus and an assembled medical devices that is configured to

Technical field

The present invention relates to medical instruments field, particularly relate to the assembled medical devices of a kind of medicine carrying sacculus and coronary artery bracket, be used for the treatment of the myocardial ischemia heart disease that causes because of coronary atherosclerosis and the disease that causes because peripheral blood vessel is narrow.

Background technology

Coronary atherosclerotic heart disease (is called for short coronary heart disease, CHD) be that IC atherosclerotic lesion causes coronarius narrow or stop up the heart disease cause, it is a kind of disease comparatively general in the cardiovascular and cerebrovascular disease, statistics shows 2010 has the people above 40% to die from cardiovascular disease in the Chinese died, hold pride of place in all causes of death.Show according to World Health Organization's data in 2011, the coronary heart disease death number of China has been listed as the second place of the world.Treatment means for coronary heart disease comprises Drug therapy, percutaneous coronary artery intervention (Percutaneous Coronary Intervention at present, PCI), coronary artery bypass grafting (also is called the cardiovascular Coronary Artery Bypass, Coronary Artery Bypass Grafting, CABG) etc., the characteristics such as wherein, PCI is little because of its wound, misery is little, post-operative recovery is fast, evident in efficacy are subject to extensive concern.

PCI originates from first Application in 1977 in clinical percutaneous tranluminal coronary angioplasty (Percutaneous Transluminal Coronary Angioplasty, PTCA), method with puncture will be inserted blood vessel with the conduit of sacculus through skin, deliver to the coronary artery place of pathological changes always, balloon expandable is opened, utilize the mechanicalness squeezing action of sacculus, with pathological changes speckle compression or cracked, coronary endometrium or part middle level are torn, again make lumen of vessels moulding, thereby the expansion tube chamber is removed narrow.But simple PTCA is because the elastical retraction of blood vessel wall and the hypertrophy of vascular smooth muscle, can occur again narrow phenomenon of tube chamber after sacculus is withdrawn from, and is known as restenosis (Restenosis), and its restenosis rate has surpassed 30%.Entered for the 1980's, round the development of PTCA, support (Stent) is introduced gradually, and at present, the PCI of PTCA+Stent has become Main Means and the main contents of percutaneous coronary intervention.

The support that PCI implants is the 316L stainless steel at first, so-called bare mental stents (Bare Metal Stent without medicine, BMS), such support can be played a supporting role to blood vessel wall after the sacculus extruding forms official jargon, avoid the elastical retraction of blood vessel, thereby reach the purpose of rebuilding blood fortune system.In a single day but owing to the elastical retraction of support self, the factors such as vascular smooth muscle hypertrophy that blood vessel causes because of the support implantable stimulation, over time, restenosis rate has still reached 15-30%, and restenosis has occured, it is very thorny that its successive treatment becomes.

2003, utilize the bracket for eluting medicament (Drug Eluting Stent, DES) of Polymer-supported inhibition of cell proliferation medicine to obtain the U.S. FDA approval at metal support surface, the beginning clinical practice is also promoted rapidly, becomes the main flow in present PCI field.In China, 2007, the application percentage of DES only had 3% PCI still to adopt BMS up to 97%.The relatively pure physical support effect of BMS, DES is when playing the physical support effect, the medicine of load can discharge in several days to the time of some months gradually on the support, thereby effectively suppressed vascular smooth muscle cell curing and reduced the Restenosis rate, the restenosis rate of PCI has been reduced to approximately 3%, has greatly lowered the risk of PCI.

But DES does not solve all problems among the PCI.In DES, because the inflammatory reaction that the introducing of pharmaceutical carrier polymeric material causes, biocompatibility reduce, the problems such as the minimal residue of coating medicine so that the endothelialization process between vascular endothelial cell and the support slow down, thereby need to be behind PCI the long-term taking anticoagulant to avoid the formation of thrombosis.And most of DES adopted the polymeric material of non-degradable type, and these nondegradable polymer retain problems such as also having brought Delayed onset thrombosis, chronic inflammatory disease, endothelium cancerization in the body for a long time.Had in 2006 and report late period of adopting DES and utmost point advanced thrombus incidence rate and BMS relatively, have slightly but increase on the statistical significance is arranged.

Except coronary heart disease, the PCI technology is also promoted the use of the narrow disease that causes for the treatment of peripheral blood vessel gradually.But similar with the PCI that uses DES in the coronary heart disease, the PCI of the narrow disease of peripheral blood vessel and DES treatment exist restenosis, advanced thrombus, long-term anticoagulant etc. to make the undesirable problem of therapeutic effect too.

Although medicine carrying sacculus interventional procedure can effectively reduce vascellum endometrial hyperplasia, avoid as metal rack, staying in the body for a long time as an alloplasm, cause the drawbacks such as persistence mechanical stretch, foreign body inflammatory reaction, but owing to there not being the existence of effective support force, the elastical retraction of blood vessel wall and the hypertrophy of vascular smooth muscle, also the restenosis phenomenon can occur late period.

Summary of the invention

The technical problem that the present invention mainly solves provides a kind of medicine carrying sacculus and an assembled medical devices that is configured to, propose to utilize medicine carrying sacculus (the Drug Coated Balloon that carries medicine, DCB) constitute a kind of novel medical apparatus and instruments with BMS, and reach therapeutic effect with the similar low restenosis rate of DES by a series of new design to sacculus and BMS, simultaneously can avoid again using the Delayed onset thrombosis that may occur behind the DES and carry out the risk that the long-term taking anticoagulant brings and avoid taking the financial burden that anticoagulant brings, and the use of the use of this new instruments and existing DES is similar, has same convenience.

For solving the problems of the technologies described above, the technical scheme that the present invention adopts is: a kind of medicine carrying sacculus and an assembled medical devices that is configured to are provided, comprise sacculus and support, the sacculus outside is coated with and contains medicine coating, support pressure is held on the sacculus outer wall, sacculus one end is provided with the conduit that is communicated with it, and the far-end of conduit is connected with catheter block.

Preferably, described sacculus is single one and expansion pressure homogeneous, and sacculus one end is in series with the conduit that communicates with it, and catheter proximal end and catheter block are fixed, and described sacculus outside is coated with and contains medicine coating, and support pressure is held on the sacculus outer wall.

Preferably, described sacculus is single one and the stepped expansion of expansion pressure, the sacculus front portion has higher expansion pressure, the sacculus rear portion has lower expansion pressure, the sacculus front end is in series with the conduit that communicates with it, catheter proximal end and catheter block are fixed, and support pressure is held on the outer wall of the sacculus front portion with higher expansion pressure.

Preferably, the sacculus of the stepped expansion of described expansion pressure is coated with in the sacculus front portion with higher expansion pressure at least and contains medicine coating.

Preferably, described sacculus is provided with a plurality of, and by conduit a plurality of sacculus series connection is communicated with between a plurality of sacculus, and the outside of at least one sacculus is coated with and contains medicine coating in described a plurality of sacculus, and described support pressure is held on the sacculus outer wall of front end.

Preferably, when described a plurality of sacculus had identical expansion pressure, a plurality of sacculus and support were arranged in the conduit, can send to respectively diseased region by the mode that pushes.

Preferably, comprise the sacculus that a plurality of parallel connections and front and back are arranged, the front end of the described a plurality of sacculus conduit that is communicated with it of connecting respectively is connected with catheter block after the many conduit parallel connections.

Preferably, in the sacculus that described a plurality of parallel connections and front and back are arranged at least the outside of the sacculus of front end be coated with and contain medicine coating, support pressure is held on the sacculus outer wall of front end.

Preferably, the sacculus of described front end has higher expansion pressure sacculus, and the sacculus of rear end has the sacculus of low expansion pressure, and the sacculus with higher expansion pressure is not less than 1kgf/cm with the difference of the expansion pressure of the sacculus with low expansion pressure²

Preferably, described support is the bare mental stents of carrying medicament not, and the material of support is a kind of of rustless steel, cochrome, platinumiridio, platinum evanohm, Nitinol, magnesium alloy, ferrum and alloy thereof, and the length of support is not less than 5mm; The material of described sacculus is one or more the combination in polrvinyl chloride, latex, polyethylene, polyethylene terephthalate, nylon, Polyetherimide, polyurethane, the silicone rubber etc.; Sacculus is positioned at an end of conduit and is communicated with conduit, can inject air, normal saline or similar compressible fluid by conduit and expand, and expansion pressure is 0.1-20kgf/cm², the length of sacculus is not less than 5mm.

The invention has the beneficial effects as follows: use a kind of medicine carrying sacculus of the present invention and an assembled medical devices that is configured to, the implantation of metal rack can be avoided the blood vessel elasticity retraction, obtains long-standing blood fortune tube chamber, rebuilds blood fortune system.In implant frame, utilize the medicine carrying sacculus to the diseased region administration, can suppress blood vessel inner cell hypertrophy, lower the generation of restenosis.And owing to the bare mental stents that only has that is retained in lesion locations does not have possibility to cause the polymer drug carrier of the ill effects such as inflammatory reaction, can avoid the formation of endothelialization difficulty and Delayed onset thrombosis, avoid postoperative long-term taking anticoagulant, have than existing bracket for eluting medicament and the simple better therapeutic effect of bare mental stents.

Description of drawings

Fig. 1 is the combinative structure schematic diagram of the single medicine carrying sacculus of the present invention load bare mental stents;

Fig. 2 is that the present invention has the series connection sacculus of identical expansion pressure and the combinative structure schematic diagram of bare mental stents;

Fig. 3 is the structural representation that the present invention has the another kind of state of combination of the series connection sacculus of identical expansion pressure and bare mental stents;

Fig. 4 is that the present invention has the series connection sacculus of different expansion pressures and the combinative structure schematic diagram of bare mental stents;

Fig. 5 is the combinative structure schematic diagram of the present invention's sacculus in parallel and bare mental stents;

Fig. 6 is the A-A cutaway view of conduit in parallel among Fig. 5 of the present invention;

Fig. 7 is the A-A cutaway view of the conduit in parallel of another kind of structure among Fig. 5 of the present invention;

Fig. 8 is that the present invention can stepped dilating sacculus and the combinative structure schematic diagram of bare mental stents;

Fig. 9 is that the present invention can stepped dilating sacculus and the structural representation of the state that is used in combination of bare mental stents;

Figure 10 is a kind of medicine carrying sacculus of the present invention and a structural representation of the assembled medical devices that is configured to.

The specific embodiment

Below in conjunction with accompanying drawing preferred embodiment of the present invention is described in detail, thereby so that advantages and features of the invention can be easier to be it will be appreciated by those skilled in the art that protection scope of the present invention is made more explicit defining.

See also Fig. 1-Figure 10, the embodiment of the invention comprises:

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, support wherein is the bare mental stents of carrying medicament not, the material of support is a kind of of rustless steel, cochrome, platinumiridio, platinum evanohm, Nitinol, magnesium alloy, ferrum and alloy thereof, and the length of support is not less than 5mm;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the material of sacculus is one or more the combination in polrvinyl chloride, latex, polyethylene, polyethylene terephthalate, nylon, Polyetherimide, polyurethane, the silicone rubber etc.;

A kind of medical apparatus and instruments that is made of sacculus and holder combination, sacculus wherein are positioned at an end of conduit and are communicated with conduit, can inject air, normal saline or similar compressible fluid by conduit and expand, and expansion pressure is 0.1-20kgf/cm², the length of sacculus is not less than 5mm;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein on all or part of sacculus load medicine, medicine can be one or more the mixture in rapamycin and derivant, paclitaxel and the derivant thereof, the load capacity of medicine is 1-10 μ g/mm²

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein on all or part of sacculus medicine of load be by be coated in balloon surface in the mode of coating after suitable binding agent mixes and carry out load, available binding agent includes but not limited to Polyethylene Glycol, macrogol ester, polyglycol ether, polysaccharide and all kinds of surfactants that share etc., and the percentage by weight of its Chinese medicine in coating is between 1-99%;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, the medicine coating that contains that wherein medicine of load and binding agent form on all or part of sacculus is that medicine and binding agent are dissolved in water, ethanol, methanol, acetonitrile, acetone, ethyl acetate, chloroform, dichloroethanes, dichloromethane, oxolane, N, in the mixed solvent of one or more in dinethylformamide, the dimethyl sulfoxide equal solvent, then be coated to balloon surface through modes such as spraying, dip-coatings, normal pressure or vacuum drying are removed the medicine coating that contains that obtains behind the solvent;

A kind of medical apparatus and instruments that is made of sacculus and holder combination, the compound mode of its medium-height trestle and sacculus are that support is held in whole medical apparatus and instruments of formation on the sacculus by pressure;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is to press on the single medicine carrying sacculus to hold bare mental stents;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is the sacculus of two arranged in series, connects by one section foley's tube between two sacculus, the sacculus of two arranged in series has identical expansion pressure;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is the sacculus of two arranged in series, connect by one section foley's tube between two sacculus, the sacculus of two arranged in series has different expansion pressures, the sacculus of rear end has lower expansion pressure and the sacculus of front end has higher expansion pressure (left is front end), and the difference of both expansion pressures is not less than 1kgf/cm²

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is the sacculus of two arranged in series, connect by one section foley's tube between two sacculus, the whole carrying medicaments of the sacculus of two series connection are held bare mental stents in a sacculus pressure of front end;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is the sacculus of two arranged in series, connect by one section foley's tube between two sacculus, the sacculus of rear end carrying medicament on the sacculus of carrying medicament and front end is not wherein pressed at a sacculus of front end and to be held bare mental stents;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is the sacculus of two arranged in series, connect by one section foley's tube between two sacculus, the sacculus of rear end carrying medicament on the sacculus of carrying medicament and front end is not wherein pressed at a sacculus of front end and to be held bare mental stents;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is the sacculus of two arranged in series, two sacculus can be all or on the sacculus of rear end load medicine is arranged, sacculus pressure at front end is possessed bare mental stents, if two sacculus have identical expansion pressure, then two sacculus and support all are placed in the outer catheter, and sacculus and support can break away from by the propelling movement of foley's tube outer catheter; If two sacculus have different expansion pressures, then need not outer catheter;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is that two conduits arranged side by side operate respectively but two sacculus in parallel of front and back layout, the sacculus of two front and back layouts has identical expansion pressure;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is that two conduits arranged side by side operate respectively but two sacculus in parallel (left is front) of front and back layout, the sacculus of arranging before and after two has different expansion pressures, wherein the rear end sacculus is the low pressure sacculus, has lower expansion pressure, and implanting saccule at front end is the high pressure sacculus, has higher expansion pressure, and the difference of the expansion pressure of two sacculus is not less than 1kgf/cm²

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is that two conduits arranged side by side operate respectively but two sacculus in parallel of front and back layout, whole carrying medicaments on two sacculus are held bare mental stents in the implanting saccule at front end pressure;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is that two conduits arranged side by side operate respectively but two sacculus in parallel of front and back layout, only have carrying medicament on the sacculus of rear end and carrying medicament not on the implanting saccule at front end, press at implanting saccule at front end and hold bare mental stents;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is that two conduits arranged side by side operate respectively but two sacculus in parallel of front and back layout, only have carrying medicament on the implanting saccule at front end and carrying medicament not on the sacculus of rear end, press at implanting saccule at front end and hold bare mental stents;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme be can stepped expansion sacculus, so-called staged expansion refers under certain expansion pressure, only have the part of sacculus to be expanded, stepped with the other parts formation of the sacculus that does not also expand.The form that consists of ladder is that the front portion of sacculus has higher expansion pressure and the sacculus rear portion has lower expansion pressure, and the difference of two-part expansion pressure is not less than 1kgf/cm²

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme be can stepped expansion sacculus, on whole sacculus load medicine, perhaps just on the rear portion of sacculus load medicine;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, wherein the sacculus in a kind of assembled scheme be can stepped expansion sacculus, bare mental stents is held in the front portion of sacculus that can stepped expansion by pressure.

A kind of medical apparatus and instruments that is made of sacculus and holder combination, wherein the sacculus in a kind of assembled scheme is to comprise single sacculus or two sacculus that series winding is arranged, also can be the sacculus of a plurality of tandem compounds.

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, its using method is to adopt Percutaneous Techniques, after determining lesion locations, make this apparatus or corresponding assistive device arrive the diseased region of intravascular space, predetermined expansion pressure is expanded and reached to external link by apparatus with normal saline or similar compressible fluid injection sacculus, make the metal rack in the combination be close to blood vessel, discharge simultaneously the medicine that loads on the sacculus, then sacculus shrinks after extracting normal saline or compressible fluid out, the sacculus that will not need to keep somewhere is in vivo afterwards withdrawn from external, and the metal rack in this medical apparatus and instruments is partly stayed predetermined diseased region, reach blood vessel dilating, rebuild the purpose of blood fortune, and the medicine that discharges is attached to the blood vessel endothelium tissue and is absorbed gradually, plays and suppresses the blood vessel endothelium hypertrophy, reduce the effect of restenosis.And according to the difference of compound mode among the present invention program, concrete using method is slightly different;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, to pressing the assembled scheme of holding bare mental stents on the single medicine carrying sacculus, after determining lesion locations, use first another one predilation sacculus that the diseased region of angiostenosis is expanded, withdraw from the medical apparatus and instruments of implanting behind this predilation sacculus in this assembled scheme, expand the sacculus in this assembled scheme, withdraw from sacculus after keeping somewhere support and discharging medicine;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, to pressing the assembled scheme of holding bare mental stents on the sacculus of two series connection, after determining lesion locations, if two sacculus of series connection have identical expansion pressure, should make then that the sacculus of rear end is at first pushed to be gone out outer catheter and arrive diseased region and expand and discharges medicine (if load has medicine), the pressure sacculus of possessing bare mental stents of front end was subject to outer catheter and limited and can not expand this moment.Extraction normal saline or similar compressible fluid after the balloon expandable of rear end is finished continue to push foley's tube and make pressure possess the also expansion of sacculus arrival diseased region of bare mental stents, withdraw from sacculus, outer catheter after keeping somewhere support and discharging medicine;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, to pressing the assembled scheme of holding bare mental stents on the sacculus of two series connection, after determining lesion locations, if two sacculus of series connection have different expansion pressures, then should make the sacculus that is positioned at the rear end at first arrive diseased region and expand and discharge medicine (if load has medicine), this moment, the pressure of front end was possessed the sacculus of bare mental stents because expansion pressure is higher can not expand.Extraction normal saline or similar compressible fluid after the balloon expandable of rear end is finished continue to push foley's tube and make and press the sacculus of possessing bare mental stents to arrive diseased region to expand and discharges medicine, the indwelling support and discharge medicine after withdraw from sacculus;

A kind of medical apparatus and instruments that is consisted of by sacculus and holder combination, to pressing the assembled scheme of holding bare mental stents on the sacculus of stepped expansion, after determining lesion locations, medical apparatus and instruments in this assembled scheme is implanted diseased region, medicine (if load has medicine) is expanded and discharged to a part with the sacculus of rear end under lower expansion pressure, extraction normal saline or similar compressible fluid after the part expansion of the sacculus of rear end is finished, continue to push sacculus and make the part arrival diseased region of the sacculus of pressing the front end of possessing bare mental stents expand and discharge medicine, withdraw from sacculus after keeping somewhere support and discharging medicine.

Embodiment 1:

The combination of single sacculus load rapamycin and 316L stainless steel stent.As shown in Figure 1, connecting material at the end with the foley'stube 2 ofcatheter block 1 of having made is thesacculus 3 of nylon 12, sacculus is not carried out convolution press hold before, sacculus is immersed in rapamycin-poloxamer alcoholic solution, make the balloon surface deposition of medicament, take out dryly, and then immerse this solution, repeated multiple timesly makeload 5 μ g/mm on the sacculus²Rapamycin-poloxamer coating 4, behind the vacuum drying sacculus is carried out convolution, afterwards thesupport 5 of a 316L stainless steel is pressed and be held in the medical apparatus and instruments that obtains single sacculus load rapamycin and the combination of 316L stainless steel stent on the sacculus, can be used for the PTCA operation;

Embodiment 2:

The paclitaxel loaded combination with L605 cochrome support of single sacculus.As shown in Figure 1, connecting material at the end with the foley'stube 2 ofcatheter block 1 of having made is thesacculus 3 of polyetheramides, sacculus is not carried out convolution press hold before, the alcoholic solution that will be on the sacculus adopts ultrasonic spraying process spraying paclitaxel-poloxamer repeated multiple timesly makesload 5 μ g/mm on the sacculus²Paclitaxel-poloxamer coating 4, behind the vacuum drying sacculus is carried out convolution, afterwards thesupport 5 of a L605 cochrome material is pressed to be held in to obtain the paclitaxel loaded medical apparatus and instruments with L605 cochrome holder combination of single sacculus on the sacculus, can be used for the PTCA operation;

Embodiment 3:

The combination with platinum evanohm support is not taken charge of in single sacculus load Yiluo.As shown in Figure 1, connecting material at the end with the foley'stube 2 ofcatheter block 1 of having made is thesacculus 3 of polyetheramides, sacculus is not carried out convolution press hold before, sacculus is immersed the rapamycin derivative Yiluo not to be taken charge of in the acetonitrile solution with poloxamer, make the balloon surface deposition of medicament, take out dryly, and then immerse this solution, repeated multiple timesly makeload 6 μ g/mm on the sacculus²Yiluo Mo Si-poloxamer coating 4, behind the vacuum drying sacculus is carried out convolution, afterwards thesupport 5 of a platinum evanohm material is pressed to be held in to obtain single sacculus load Yiluo on the sacculus and do not take charge of medical apparatus and instruments with platinum evanohm holder combination, can be used for the PTCA operation;

Embodiment 4:

Have identical expansion pressure and two sacculus all the series connection sacculus of load rapamycin and the combination of platinumiridio support.As shown in Figure 2, connecting material at the end with the foley'stube 2 ofcatheter block 1 of having made issacculus 3 and thesacculus 7 of polyetheramides, two sacculus connect with onesection conduit 6 and have an identical expansion pressure, sacculus is not carried out convolution press hold before, the alcoholic solution that will be on two sacculus adopts ultrasonic spraying process spraying rapamycin-poloxamer repeated multiple timesly makesload 3 μ g/mm on the sacculus²The containingmedicine coating 4 and containmedicine coating 8 of rapamycin, behind the vacuum drying sacculus is carried out convolution, afterwards thesupport 5 of a platinumiridio material is pressed and be held on thesacculus 3 of front end, whole foley's tube is placed anouter catheter 5, thereby obtain the medical apparatus and instruments of series connection sacculus load rapamycin and platinumiridio holder combination, can be used for the PTCA operation.

As shown in Figure 3, in this compositions, medical instrumentation process, at first foley's tube is sent to the lesion locations front end together with outer tube, pushing foley's tube makessacculus 7 arrive lesion locations, obtain tube chamber and discharge the medicine that contains in themedicine coating 8 with the normal saline expansion, taking out afterwards normal saline shrinkssacculus 7, again pushing foley's tube makessacculus 3 arrive diseased region together withsupport 5, again with normal saline injection thissacculus 3 of expansion andsupport 5, and discharge the medicine that contains in themedicine coating 4, after taking out normal saline, withdraw from sacculus, foley's tube and outer tube are retained in diseased region withsupport 5;

Embodiment 5:

Have identical expansion pressure and only have the paclitaxel loaded series connection sacculus of the sacculus of front end and the combination of nick-eltitanium alloy stent.Identical withembodiment 4, just the medicine in the combination is paclitaxel, and load capacity is 6 μ g/mm², support is the Nitinol material, and does not containmedicine coating 8 onsacculus 7;

Embodiment 6:

Have different expansion pressures and two sacculus all the series connection sacculus of load rapamycin and the combination of L605 cochrome support.Shown in 4, connecting material at the end with the foley'stube 2 ofcatheter block 1 of having made is thatsacculus 3 and the material of polyetheramides is nylon 12sacculus 7, two sacculus connect with onesection conduit 6 and have different expansion pressures, whereinsacculus 7 is low pressure sacculus, can under lower expansion pressure, open, andsacculus 3 is high pressure sacculus, need to open under higher expansion pressure.Sacculus is not carried out convolution press hold before, adopt the alcoholic solution of ultrasonic spraying processes spraying rapamycin-poloxamers at two sacculus, repeated multiple times making contained 3 μ g/mm in the load on the sacculus²The containingmedicine coating 4 and containmedicine coating 8 of rapamycin, behind the vacuum drying sacculus is carried out convolution, afterwards thesupport 5 of a L605 cochrome material is pressed and be held on thesacculus 3 of front end, thereby obtain the medical apparatus and instruments of series connection sacculus load rapamycin and L605 cochrome holder combination, can be used for the PTCA operation.

In this compositions, medical instrumentation process, at first foley's tube is sent to the lesion locations front end, pushing foley's tube makessacculus 7 arrive lesion locations, obtain tube chamber and discharge the medicine that contains in themedicine coating 8 with the normal saline expansion, taking out afterwards normal saline shrinkssacculus 7, again pushing foley's tube makessacculus 3 arrive diseased region together withsupport 5, again with normal saline injection thissacculus 3 of expansion andsupport 5, and discharge the medicine that contains in themedicine coating 4, after taking out normal saline, withdraw from sacculus, foley's tube,support 5 is retained in diseased region;

Embodiment 7:

Have different expansion pressures and only have the paclitaxel loaded series connection sacculus of the sacculus of front end and the combination of 316L stainless steel stent.As shown in Figure 4, similar toembodiment 6, just the medicine in the combination is paclitaxel, and load capacity is 5 μ g/mm², support is the 316L stainless steel, and does not containmedicine coating 8 onsacculus 7;

Embodiment 8:

Have different expansion pressures and only have the paclitaxel loaded series connection sacculus of the sacculus of rear end and the combination of L605 cochrome support.As shown in Figure 4, similar toembodiment 6, just the medicine in the combination is paclitaxel, and load capacity is 5 μ g/mm², and onsacculus 3, do not containmedicine coating 4;

Embodiment 9:

Have identical expansion pressure and two sacculus all sacculus in parallel of load rapamycin and the combination of L605 cochrome support.As shown in Figure 5, connecting material at the end with the foley's tube 2 of catheter block 1 of having made is the sacculus 3 of polyetheramides, connecting 6, two sacculus of sacculus that material is polyetheramides at another end with the foley's tube 8 of catheter block 9 arranges because the difference of foley's tube length forms front and back.Foley's tube 2 and foley's tube 8 parallel connections also link together, more specifically both connected modes can be any one in the cross-sectional view of Fig. 6 and foley's tube 2 shown in Figure 7 and foley's tube 8, the unitary catheter that can be a diplopore also can be two independently conduit be bonded together.Sacculus 3 has identical expansion pressure with sacculus 6, but can be by two foley's tube seats and the independent enlargement and contraction of foley's tube difference.Sacculus is not carried out convolution press hold before, adopt the alcoholic solution of ultrasonic spraying processes spraying rapamycin-poloxamers at two sacculus, repeated multiple times making contained 3 μ g/mm in the load on the sacculus²The containing medicine coating 4 and contain medicine coating 7 of rapamycin, behind the vacuum drying sacculus is carried out convolution, afterwards the support 5 of a L605 cochrome material is pressed and be held on the sacculus 3 of front end, thereby obtain the medical apparatus and instruments of sacculus load rapamycin in parallel and L605 cochrome holder combination, can be used for the PTCA operation.

In this compositions, medical instrumentation process, at first foley's tube is sent to the lesion locations front end, pushing foley's tube makessacculus 6 arrive lesion locations, obtain tube chamber and discharge the medicine that contains in themedicine coating 7 by foley'stube seat 9 and the expansion of foley'stube 8 usefulness normal saline, taking out afterwards normal saline shrinkssacculus 6, again pushing foley's tube makessacculus 3 arrive diseased region together withsupport 5, again expand thissacculus 3 andsupport 5 with the normal saline injection by foley'stube seat 1 and foley'stube 2, and discharge the medicine that contains in themedicine coating 4, after taking out normal saline, withdraw from sacculus, foley's tube is retained in diseased region withsupport 5;

Embodiment 10:

Have different expansion pressures and two sacculus all paclitaxel loaded sacculus in parallel and the combination of 316L stainless steel stent.Such as Fig. 5, Fig. 6, shown in Figure 7, similar toembodiment 9, just sacculus 3 andsacculus 6 are to use respectively polyetheramides and polyurethane manufacturing, have different expansion pressures, and the medicine of load is paclitaxel, and the support material is the 316L rustless steel;

Embodiment 11:

Have different expansion pressures and only have the combination of the paclitaxel loaded sacculus in parallel of implanting saccule at front end and L605 cochrome support.Such as Fig. 5, Fig. 6, shown in Figure 7, similar toembodiment 9, just sacculus 3 andsacculus 6 are to use respectively polyetheramides and polyurethane manufacturing, have different expansion pressures, and the 6 μ g/mm that only had on thesacculus 3 load²Paclitaxel contain medicine coating, carrying medicament not on thesacculus 6;

Embodiment 12:

Have different expansion pressures and only have the combination of the paclitaxel loaded sacculus in parallel of rear end sacculus and platinum evanohm support.Such as figure Fig. 5, Fig. 6, shown in Figure 7, similar toembodiment 9, just sacculus 3 andsacculus 6 are to use respectively nylon 12 and silicone rubber manufacturing, have different expansion pressures, and the 6 μ g/mm that only had on thesacculus 6 load²Paclitaxel contain medicine coating, carrying medicament not on thesacculus 3, and the support material is the platinum evanohm;

Embodiment 13:

Can stepped expansion and whole paclitaxel loaded sacculus and the combination of L605 cochrome support.As shown in Figure 8, connecting material at the end with the foley'stube 2 ofcatheter block 1 of having made is thesacculus 3 of nylon 12, whereinsacculus 3 be one can stepped expansion sacculus, the expansion pressure of the sacculusfront end 7 of close foley's tube end is lower, and higher away from the expansion pressure of the sacculusrear end 4 of catheter tip, sacculus is not carried out convolution press hold before, sacculus is immersed in paclitaxel-poloxamer alcoholic solution, make the balloon surface deposition of medicament, take out dry, and then immerse this solution, repeated multiple timesly makeload 5 μ g/mm on the sacculus²Paclitaxel-poloxamer coating 5 andcoating 8, behind the vacuum drying sacculus is carried out convolution, afterwards thesupport 6 of a L605 cochrome material is pressed to be held in to obtain medical apparatus and instruments can stepped dilating sacculus paclitaxel loaded and L605 cochrome holder combination on the sacculusrear end 4, can be used for the PTCA operation;

In this compositions, medical instrumentation process, at first foley's tube is sent to the lesion locations front end, pushing foley's tube makes the sacculusfront end 7 of low pressure expansion arrive lesion locations, obtain tube chamber and discharge the medicine that contains in themedicine coating 8 by foley'stube seat 1 and the expansion of foley'stube 2 usefulness normal saline, as shown in Figure 9, taking out afterwards normal saline shrinks sacculusfront end 7, again pushing foley's tube makes sacculusrear end 4 arrive diseased region together withsupport 6, again expand this sacculusrear end 4 andsupport 6 with the normal saline injection by foley'stube seat 1 and foley'stube 2, and discharge the medicine that contains in themedicine coating 5, after taking out normal saline, withdraw from sacculus, foley's tube is retained in diseased region withsupport 6;

Embodiment 14:

Can stepped expansion and only have the sacculus of a part of load rapamycin of sacculus of front end and combination such as Fig. 8, shown in Figure 9 of platinumiridio support, similar to embodiment 13, just wherein medicine is rapamycin, load capacity is 8 μ g/mm², and only on sacculusrear end 4load medication coat 5, do not containmedicine coating 8, and the support material is platinumiridio;

Embodiment 15:

Can stepped expansion and only have the paclitaxel loaded sacculus of the part of sacculus of rear end and combination such as Fig. 8, shown in Figure 9 of magnesium alloy bracket, similar to embodiment 13, just wherein the load capacity of drug taxol is 8 μ g/mm²And only on sacculusfront end 7load medication coat 8, do not containmedicine coating 5, and the support material is magnesium alloy, the purpose that adopts magnesium alloy is that this support can be degraded gradually after implanting diseased region, absorption, metabolism and final the disappearance, in the needs support force, there is implantation instrument to exist thereby reach, and recovers the natural attribute of blood vessel when finishing vascular repair and need not support force fully;

Embodiment 16:

Be used for the peripheral blood vessel pathological changes the long ball capsule can stepped dilating sacculus and the combination of L605 cochrome support.Similar to embodiment 13, just wherein sacculus is the sacculus that is applicable to the peripheral blood vessel pathological changes, has larger length and diameter, and corresponding support also has larger diameter.

A kind of medicine carrying sacculus of the present invention can be avoided the blood vessel elasticity retraction with an assembled medical devices that is configured to, the implantation of metal rack, obtains long-standing blood fortune tube chamber, rebuilds blood fortune system.In implant frame, utilize the medicine carrying sacculus to the diseased region administration, can suppress blood vessel inner cell hypertrophy, lower the generation of restenosis.And owing to the bare mental stents that only has that is retained in lesion locations does not have possibility to cause the polymer drug carrier of the ill effects such as inflammatory reaction, can avoid the formation of endothelialization difficulty and Delayed onset thrombosis, avoid postoperative long-term taking anticoagulant, have than existing bracket for eluting medicament and the simple better therapeutic effect of bare mental stents.

The above only is embodiments of the invention; be not so limit claim of the present invention; every equivalent structure or equivalent flow process conversion that utilizes description of the present invention and accompanying drawing content to do; or directly or indirectly be used in other relevant technical fields, all in like manner be included in the scope of patent protection of the present invention.

Claims (10)

1. a medicine carrying sacculus and an assembled medical devices that is configured to, it is characterized in that: comprise sacculus and support, the sacculus outside is coated with and contains medicine coating, and support pressure is held on the sacculus outer wall, sacculus one end is provided with the conduit that is communicated with it, and the far-end of conduit is connected with catheter block.

2. a kind of medicine carrying sacculus according to claim 1 and an assembled medical devices that is configured to, it is characterized in that: described sacculus is single one and expansion pressure homogeneous, sacculus one end is in series with the conduit that communicates with it, catheter proximal end and catheter block are fixed, described sacculus outside is coated with and contains medicine coating, and support pressure is held on the sacculus outer wall.

3. a kind of medicine carrying sacculus according to claim 1 and an assembled medical devices that is configured to, it is characterized in that: described sacculus is single one and the stepped expansion of expansion pressure, the sacculus front portion has higher expansion pressure, the sacculus rear portion has lower expansion pressure, the sacculus front end is in series with the conduit that communicates with it, catheter proximal end and catheter block are fixed, and support pressure is held on the outer wall of the sacculus front portion with higher expansion pressure.

4. a kind of medicine carrying sacculus according to claim 3 and an assembled medical devices that is configured to, it is characterized in that: the sacculus of the stepped expansion of described expansion pressure is coated with in the sacculus front portion with higher expansion pressure at least and contains medicine coating.

5. according to claim 1 and 2 or 3 or 4 described a kind of medicine carrying sacculus and an assembled medical devices that is configured to, it is characterized in that: described sacculus is provided with a plurality of, and by conduit a plurality of sacculus series connection are communicated with between a plurality of sacculus, the outside of at least one sacculus is coated with and contains medicine coating in described a plurality of sacculus, and described support pressure is held on the sacculus outer wall of front end.

6. a kind of medicine carrying sacculus according to claim 5 and an assembled medical devices that is configured to, it is characterized in that: when described a plurality of sacculus have identical expansion pressure, a plurality of sacculus and support are arranged in the conduit, can send to respectively diseased region by the mode that pushes.

7. a kind of medicine carrying sacculus according to claim 1 and an assembled medical devices that is configured to, it is characterized in that: comprise the sacculus that a plurality of parallel connections and front and back are arranged, the front end of the described a plurality of sacculus conduit that is communicated with it of connecting respectively is connected with catheter block after the many conduit parallel connections.

8. a kind of medicine carrying sacculus according to claim 7 and an assembled medical devices that is configured to, it is characterized in that: in the sacculus that described a plurality of parallel connections and front and back are arranged at least the outside of the sacculus of front end be coated with and contain medicine coating, support pressure is held on the sacculus outer wall of front end.

9. a kind of medicine carrying sacculus according to claim 8 and an assembled medical devices that is configured to, it is characterized in that: the sacculus of described front end has higher expansion pressure sacculus, the sacculus of rear end has the sacculus of low expansion pressure, and the sacculus with higher expansion pressure is not less than 1kgf/cm with the difference of the expansion pressure of the sacculus with low expansion pressure²

10. a kind of medicine carrying sacculus according to claim 1 and an assembled medical devices that is configured to, it is characterized in that: described support is the bare mental stents of carrying medicament not, the material of support is rustless steel, cochrome, platinumiridio, the platinum evanohm, Nitinol, magnesium alloy, ferrum and alloy thereof a kind of, the length of support is not less than 5mm, the material of sacculus is polrvinyl chloride, latex, polyethylene, polyethylene terephthalate, nylon, Polyetherimide, polyurethane, the combination of one or more in the silicone rubber etc., sacculus is positioned at an end of conduit and is communicated with conduit, can inject air by conduit, normal saline or similar compressible fluid are expanded, and expansion pressure is 0.1-20kgf/cm², the length of sacculus is not less than 5mm..

Images