CN101516291A

CN101516291A - Bioabsorbable polymeric medical device

Info

Publication number: CN101516291A
Application number: CNA2007800346915A
Authority: CN
Inventors: R·J·科顿; S·叶; J·帕齐恩扎
Original assignee: Orbus Medical Technologies Inc
Current assignee: Orbus Medical Technologies Inc
Priority date: 2006-07-20
Filing date: 2007-07-20
Publication date: 2009-08-26
Anticipated expiration: 2027-07-20
Also published as: CN101516291B; CN101522754B; CN101522754A

Abstract

In embodiments there is described a cardiovascular tube-shaped lockable and expandable bioabsorbable scaffold having a low immunogenicity manufactured from a crystallizable bioabsorbable polymer composition or blend.

Description

But the polymeric medical device of bio-absorbable

The mutual reference of related application

The application requires to enjoy 60/807,932 the priority of submitting in 20,60/862,433 and 2006 on July that the U.S. Provisional Application submitted on April 20th, 2007 October 20 in 60/913,264,2006 submitted to.

List of references of being quoted in this description and their list of references, when be applicable to instruction other or when alternative details, feature and/or technical background, include in this description in full by the mode of quoting as proof.

Technical field

The polymeric medical device of cavity configuration the present invention relates to be used to implant.Particularly, this medical apparatus and instruments comprises a kind of like this polymer architecture, but this polymer is configured to coincide with intracoelomic cavity structure (for example blood vessel) is inner for bio-absorbable, biocompatible and its structure.This medical apparatus and instruments can be used for treating disease, for example the little pipe choking of atherosclerosis, restenosis and other type.

Background technology

A kind of new medical apparatus and instruments is disclosed in the embodiment of the present invention, for example a kind of expandable tubulose angiocarpy bracket with one or more curved structure entities.Described new medical apparatus and instruments can comprise that at its end a kind of closing means is in crimped position to guarantee this apparatus on carrier arrangement, to be used for expansion.This closing means provides guarantees that crimped stent is positioned at the constructional device on the carriage assembly, thereby makes described support remain in the fixed position in the process of inserting and send to the therapeutic goal zone.This apparatus is implanted or its expansion structure by this carrier module overcomes unless the locking of this support restriction can be maintained to.

Find to use metallic support pipe (stenting) to treat that a secular problem is to form scar tissue, promptly so-called restenosis process all around at this apparatus when inserting this apparatus in the vascular injury site after in (for example treating vascular occlusion).A lot of people think and have the lasting risk that forms the stay pipe thrombosis, and this is that this therapy is intended to avoid described infringement because lasting existence independent or that contain metal stay pipe in the blood vessel of drug coating compositions causes.In addition, metal or non-absorbable polymer stay pipe can stop vessel lumen to reinvent and expand.

Wound healing process is all experienced in known any damage to bodily tissue or organ, and described process comprises that for example 1 Collagen Type VI synthesizes and particularly, smooth muscle cell moves from blood vessel, and it has caused companion's row property sclerosis in healing zone and narrowing down again of blood vessel diameter.Therefore,, have enough plasticity in requisition for support and dampen or the blood capillary damage for example invasive operation carried out of support implantable intravascular of medical apparatus and instruments by operation to avoid the blood vessel wall during support expands and settle support in area for treatment.

Another long term object of avoiding restenosis is for there not being the operation that undergos surgery of the very low basically medical apparatus and instruments of immunogenicity or immunogenicity.

Implant the back because the lasting existence of metallic support pipe causes the lasting risk that forms stent thrombosis, this risk is not as yet by using the pharmaceutical composition bag for avoiding described problem to produce to be overcome by the means of metal structure.On the contrary, the mortality rate that these coatings caused is high.In addition, metal or polymer non-absorb stay pipe and can stop vessel lumen to reinvent and expand.Attempted that several different methods is avoided or callus and reduce immunoreactive complement activation or platelet aggregation.And, need to eliminate or be reduced in the inflammatory response at implantation site place and reduce implant and/or the possibility of its component material wound when decomposing.Find improving target and being used for implanting of the expectation shape of medical apparatus and instruments of---particularly implantable intravascular---and the flexibility of structure for needing to improve.

The reference document

The United States Patent (USP) 6 of reference mandate on August 19th, 2003,607,548 B2 (Inion), the document discloses uses a kind of polymer or copolymer and one or more copolymer additives blend and the biocompatibility biology that makes compositions of absorbing material again based on lactic acid or glycolic.But this list of references disclose the implant that makes by these materials for cold bend(ing) and flawless or break.EP 0401844 discloses the blend of a kind of poly-L-lactide and poly-D-DL-lactide.United States Patent (USP) 6,001,395 disclose the platy particle of biodegradable poly (L-lactide) or its copolymer or blend---to small part be crystal---medicine send.United States Patent (USP) 7,070,607 disclose a kind of aneurysm repair coil, but it comprises a kind of polymeric material that is loaded with the bio-absorbable of suppository, wherein thrombosis is controlled by polymers compositions.

Summary of the invention

The inventor especially has recognized that to be needed to improve the implant configuration, comprises support/stay pipe configuration of using in the body.The inventor also recognizes needs a kind of biocompatible polymer blend that is used for implant (for example stay pipe and blood vessel synthetic graft) of exploitation, thereby is providing a kind of Toughening Mechanism to matrix polymer when this medical apparatus and instruments is used in the body.They suppose that this Toughening Mechanism can make under the physiological condition to promote enough molecular motions by extra molecule free volume being given matrix polymer, and---especially when putting on other molecular force on the implant---the generation recrystallization is implemented.They have theorized and have thought, thereby the molecule free volume of raising also can improve speed increase plasticizing effect and raising bulk degradation kinetics that water absorbs.

For example, this medical apparatus and instruments can comprise a kind of like this polymer with low immunologic rejection performance, but for example a kind of polymer composition of bio-absorbable or blend, it has had balance elasticity, rigidity and flexible mixing machinery performance.But the host material that this polymer composition can be by bio-absorbable and a kind of copolymer or trimer additive produce low antigenicity, but the limiting examples of described host material is polymer, copolymer or the trimer of bio-absorbable.The polymer architecture of these types can advantageously carry out enzymatic degradation and absorption in vivo.Particularly, this new compositions can be carried out " soft " degradation mechanism in vivo, and catabolite or polymers compositions damage less to surrounding tissue and reduce the restenosis reaction or suppress restenosis fully thereby this mechanism is slowly carried out.

The present inventor also proposes so new design, but this design can use the biodegradable material of the biocompatibility of described bio-absorbable making favourable support, but described support usual practice after one's own heart the blood vessel system provide and be very suitable for flexibility and the extensibility in the motion of beating, contraction and diastole, implanted.

Embodiment disclosed herein comprises medical apparatus and instruments, for example stay pipe, synthetic graft and conduit, and it can comprise or can not comprise the intravital Bioabsorbable polymeric composition of a kind of implantation patient.

In one embodiment, a kind of angiocarpy bracket (for example a kind of stay pipe) of tubular expansile is provided, it has low rejection or immunogen effect after implantation, it is prepared from by Bioabsorbable polymeric composition or blend, said composition or blend have had balance elasticity, rigidity and flexible mixing machinery performance, these performances make that support tube is crooked and are crimped onto the inflatable delivery system that is used for the blood vessel implantation.This apparatus can be used for treating for example angiopathy (as atherosclerosis and restenosis), and can a kind ofly curl and/or expandable structure provides, and these structures can be used with balloon angioplasty.

In one embodiment, medical apparatus and instruments can a kind of expandable stent form provide, thereby this expandable stent comprises multiple tortuous pillar part or structure and forms a kind of firm structure, for example along the circulus of the circumference of the multiple apparatus of style (for example for support, without limitation for spread all over this structure, only opening or its in conjunction with).Thereby tortuous corbeling can be settled adjacent one another are and/or in the opposite direction and make them along this apparatus longitudinal axis overall radial and expansion equably on the length direction of this expandable stent.In one embodiment, this expandable stent can comprise choosing wantonly to have the branched particular style in side, for example has cell structure, the double-spiral structure of even framework.

In one embodiment, but the flexible support of bio-absorbable forms a kind of like this pipe with the circumference form around the longitudinal axis, and this pipe has nearly opening and opening far away, and can be expanded to a kind of expansion structure by expansion structure not, and flexible; Described support with the style shape that exists with expanded form comprises:

A) a plurality of first tortuous pillar cellular construction (pattern), each first tortuous pillar cellular construction is connected to each other, thereby forms a kind of interconnective screen design with the circumference form around the longitudinal axis; And

B) at least two second pillar cellular constructions that are inserted in interconnective screen design inside, each described second pillar cellular construction comprises the hoop that forms around the longitudinal axis with the circumference form, described hoop has near the inner surface of the longitudinal axis and is positioned at the outer surface of longitudinal axis far-end, and is vertical with the longitudinal axis and be positioned at same plane substantially along the hoop surfaces externally and internally of circumference.

In one embodiment, the first tortuous pillar cellular construction generally is parallel to the described longitudinal axis, general and described longitudinal axis oblique, generally vertical with the described longitudinal axis or generally coaxial with it around the described longitudinal axis.The second pillar cellular construction can be by a kind of material preparation, and it is crystallization basically when described pipe is in swelling state, but non-crystallizable basically when non-expansion state.The second pillar cellular construction can comprise that at least one has the hoop of flexible space (through-void), wherein said flexible space is configured to hold when described at least one hoop and is subjected to dilating effect power and radius when expanding, and this active force surpasses the swelling state of its nominal but do not cause binding round destroyed.

In one embodiment, each first tortuous pillar cellular construction of this support is sine curve substantially, and each second pillar cellular construction is non-sinusoidal cuve substantially.Each first tortuous pillar cellular construction of support can be extended to its opening far away by the nearly opening of pipe.In another embodiment, each second pillar cellular construction can be present in nearly opening and opening far away.In one embodiment, each second pillar cellular construction also is present between nearly opening and the opening far away.

In one embodiment, this support can comprise such structure, and wherein each second pillar cellular construction can be present between nearly opening and the opening far away but not be positioned at nearly opening and opening far away.In another embodiment, this support can comprise such structure, and wherein the second pillar cellular construction can be present in nearly opening or the opening far away at least one.

In a specific embodiments, this support comprises such stay pipe, and it has unexpansive configuration and expanded configuration; An outer tubular surface and an inner tubular surface, described stay pipe comprises: in unexpansive configuration, have remarkable fluctuating style and in expanded configuration, do not have a plurality of biodegradable, paired, the isolating circumference band of fluctuating style substantially and stride each between the circumference band and with paired band in each with on a plurality of biodegradable interconnection structure that is connected of a plurality of points, the fluctuating of above-mentioned biodegradable, paired, isolating circumference band support be in exist under the non-expansion state and be in be included under the swelling state basic in the planar ring.

Fluctuating style when in one embodiment, this stay pipe interconnection structure comprises unexpansive and two kinds of configurations of expansion.In another embodiment, this interconnection structure comprises a kind of like this style, and wherein this style does not comprise the style that contains fluctuating when unexpansive and two kinds of configurations of expansion.The interconnecting structure and can between the fluctuating of paired circumference band, expand of this stay pipe.

In one embodiment, at least one in a plurality of paired biodegradable circumference bands comprise the radiopaque material along its outer tubular surface, and this radiopaque material can pass through radiography, MRI or spiral CT technology for detection.Perhaps, at least one interconnects structure and contains the radiopaque material along the outer surface of its pipe, and this radiopaque material can pass through radiography, MRI or spiral CT technology for detection.In the recess that this radiopaque material one of can be placed in each circumference band, perhaps place the recess that interconnects one of structure.In one embodiment, at least one that interconnects at least one and the circumference band in the structure comprises the radiopaque material along the outer tubular curved surface, and this radiopaque material can pass through radiography, MRI or spiral CT technology for detection.

In another embodiment, but the flexible support of bio-absorbable roughly forms a kind of like this pipe with the circumference form around the longitudinal axis, and this pipe has nearly opening and opening far away, and flexible and inflatable; And under expanded form, comprise:

A) be positioned at at least two rings of circumference form around the longitudinal axis, this ring has inner surface near the longitudinal axis, away from the outer surface of the longitudinal axis, the bottom surface of approaching the end face of nearly opening and approaching opening far away, it is vertical with the longitudinal axis and be positioned at same plane substantially to be positioned at ring surfaces externally and internally around circumference, and

B) between described at least two rings and around a plurality of tortuous pillar cellular construction of longitudinal axis circumference; Described a plurality of tortuous pillar cellular constructions and described ring are connected at least two junction points that respectively encircle on the circumference, and each junction point on this ring circumference is positioned on top surface of ring and the ring bottom surface; Wherein being positioned at the ring upper surface each point that is connected with any concrete ring above and that lower surface is following is symmetrical configuration.

In one embodiment, this support comprises a kind of like this structure, wherein is positioned at the above and junction point of the ring that the ring lower surface is following of ring upper surface, the alphabetical H configuration that tortuous pillar cellular construction forms a special format together.In another embodiment, this support can comprise a kind of like this structure, wherein is positioned at the sine curve that forms two adjacency more than the ring upper surface with the tortuous pillar cellular construction below the ring lower surface together at the junction point place of ring.In another embodiment, this support can comprise a kind of like this structure, wherein is positioned at more than the ring upper surface at the junction point place of ring and the tortuous pillar cellular construction that encircles below the lower surface forms two sine curves with the coherent structure that is connected this cellular construction and ring.In one embodiment, the junction point of this ring has 2 to 6 tortuous pillar cellular constructions connections in each junction.

In another embodiment, thus expandable biodegradable tubular bracket comprises a plurality of biodegradable first curved structures forms interconnective net.This net circumferentially extends around the longitudinal axis; Wherein each biodegradable first curved structure is by the raceme polymer manufacture, the crystallization under the expansion power of tubular bracket of this raceme polymer, and comprise a plurality of biodegradable second curved structures, each second curved structure circumferentially extends around the longitudinal axis in separated from one another and each comfortable plane, and this second curved structure is inserted in first curved structure and interconnects with it.In this embodiment, first curved structure of this support generally is parallel to the longitudinal axis, general and longitudinal axis oblique, generally vertical with the longitudinal axis or generally coaxial with it around the described longitudinal axis.Second curved structure is made by a kind of like this material, crystallization when this material is in its swelling state at pipe and non-crystallizable basically during at its non-expansion state; And at least one in second curved structure comprises at least one flexible space, and wherein said flexible space is configured to allow second parts to stretch and these parts are not destroyed.

In one embodiment, first curved structure forms a kind of like this pillar cellular construction, and it is sine curve when this pipe is expanded form; Second curved structure forms a kind of like this pillar cellular construction, and it is non-sinusoidal cuve when this pipe is expanded form.In this embodiment and other embodiment, first curved structure forms a kind of like this pillar cellular construction, and its nearly opening by pipe extends to opening far away; Second curved structure forms a kind of like this pillar cellular construction, and it is present in nearly opening and open end far away.Second curved structure also can form a kind of like this pillar cellular construction, and it also is present between nearly opening and the open end far away; Perhaps second curved structure forms a kind of like this cellular construction, and it is present between nearly opening and the opening far away but is not formed at nearly opening or opening far away.

In another embodiment, a kind of method for preparing tubular bracket comprises: prepare a kind of raceme and gather-the lactide mixture; Make a kind of raceme poly--the biodegradable polymer pipe of lactide mixture; This pipe of cut is to forming described support.In this embodiment, the manufacturing of support can use forming technique or expressing technique to carry out, and described forming technique is solvent-free substantially.

A kind of like this method of making tubular bracket also is provided, it comprises: a kind of like this polymer composition that contains crystallizable compositions of blend, described crystallizable compositions comprises the poly-L-lactide that is connected with modified copolymer or the matrix polymer of poly-D-lactide, described modified copolymer comprises poly-L (or D)-common-propylene carbonate or poly-L (or D)-common-6-caprolactone of block copolymer or block random copolymer form, and wherein lactide chain length long enough is so that the crosslink part crystallization takes place; Make this polymer composition molding so that described supporting structure is shaped; And cut this support to form required support style.In this embodiment, this blend composition comprises the racemic mixture of a kind of poly-L-lactide and poly-D-lactide.Therefore, the medical apparatus and instruments of being made by this method is stay pipe for example, is made up of the racemic mixture of a kind of poly-L and poly-D-lactide basically.In this embodiment, this stay pipe can comprise for example propylene carbonate of other polymeric material.Comprise that at apparatus in the embodiment of trimethyl carbonate, the amount of trimethyl carbonate is no more than more than 40% of weight support frame.

In another embodiment, provide a kind of so expandable tubular bracket, this support has near-end and the far-end that limits around the longitudinal axis.This support comprises:

(a) a plurality of first tortuous pillar part, these parts are interconnected with one another at least one point and sentence a kind of circumference tubular structure of formation, and this first tortuous pillar part forms flexible and expandable tubular reticulum;

(b) the second tortuous pillar part, thus it is shaped effectively and can curls and inflatable and be shaped to form the ring-type pillar of support after expansion; And

(c) make bracket locked in the locking device of crimped position;

Wherein but this support comprises expand crystallizable bio-absorbable raceme polymer composition or blend.

In a kind of embodiment of a lock, tubular bracket can comprise such structure, and wherein this locking device is two parts parts, and it is to be positioned at or near the near-end of this tubular bracket and or different tortuous pillar parts of far-end.In this embodiment, two parts parts of this locking device can for example be positioned at the snap engagement of the tortuous position of support, and wherein this locking tool expands by support and is separated.In another embodiment, tubular bracket can comprise such locking device, and this locking device comprises buckle spoon lock configuration, and wherein this design class is like dovetail head dummy interlocking instrument.This tubular bracket also can comprise these locking devices, and it comprises the buckle spoon lock configuration that is similar to ball joint type interlock; Hook the bracket etc. of end component of the reverse shaping of plastic stent.

Tubular bracket can be set at or be carried on the inflatable air bag carrier arrangement, and its size can be set to the diameter that can be extended to the interior intracavity that is enough to the implantable intravascular system by the crimp tube diameter.

In another embodiment, expandable stent comprises the tortuous pillar of one group of interlocking, the stable implant frame that expands or implant configuration that is in of this pillar, and molecule orientation and crystallization again take place in its medium-height trestle polymer during expansible radial strain.This support can be changed to taper shape or its combination by cylindrical.In each embodiment as herein described, the biodegradable polymers of this support shows enough slow degradation kinetics to avoid tissue overload or other inflammatory reaction.The polymer core material comprises at least a encapsulated medicine that is used for the topical therapeutic of blood vessel wall and inner chamber.

This tubular bracket also can comprise one or more drug substances, and it can be encapsulated in and be used for the local paradigmatic structure that discharges medicine and treatment and prevention tissue inflammation and platelet aggregation.This tubular bracket also can comprise at least a adhering to or the embedding recognition marks, and it can be and comprises a radiopaque or fill the air radiopaque adhering to or the identification tag of embedding.

This tubular bracket also can comprise like this some tortuous pillars, and it can be by comprising the ringlet adapter interlocking that is selected from one or more following configurations: H shape, X shape, perforation be circular, two adjacent H shapes, three connections of adhering to, two adjacent parallel connect, the sine of parallel strut connects.

In another embodiment, but the flexible support of bio-absorbable forms a kind of like this pipe with the circumference form around the longitudinal axis, and this pipe has nearly opening and opening far away, and flexible and inflatable; It comprises:

(b) the second tortuous pillar part, thereby it is shaped effectively and can curls and inflatable and be shaped to form the hoop shape pillar of support after expansion, wherein this hoop shape pillar have inner surface near the longitudinal axis, away from the outer surface of the longitudinal axis, the bottom surface of approaching the end face of nearly opening and approaching opening far away; The second tortuous pillar part and a plurality of first tortuous pillar part interconnect; And

(c) be positioned at the inner surface that approaches the second tortuous pillar part or at least one pair of locking mechanism of outer surface, this is shaped to effectively locking each other when support is in non-expansion state to locking mechanism, but separated from one another when support is in swelling state.

This support can comprise such pair of locking mechanism, and it comprises bracket connected to one another when support is in non-expansion state; The locking mechanism that comprises relative convex-concave adapter; Some locking mechanisms like this, it comprises the adapter that is adjacent to each other with frangible connection when this support is in non-expansion state, but isolating adapter when frangible connection is broken when this support is in swelling state; The latch-up structure that comprises dovetail head dummy interlocking adapter; Some locking mechanisms like this, it comprises the parts of bracket and the second tortuous pillar part when this support is in non-expansion state, and forms the bracket that extends since the second tortuous pillar part and the recess in these parts when this support is in non-expansion state.The locking mechanism of described pipe can lock in the time of can and being contained on the inflatable air bag carrier arrangement by suitable shaping and arrangement so that at non-expansion state.

In another embodiment, but the flexible support of the bio-absorbable that can curl forms a kind of like this pipe with the circumference form around the longitudinal axis, this pipe has nearly opening and opening far away, and can be expanded to a kind of expansion structure by expansion structure not, and contain locking mechanism and lock onto on another with parts with support, the support that has the style shape under the expanded form comprises:

(a) a plurality of first tortuous pillar cellular construction, thus each first tortuous pillar cellular construction is interconnected with one another with the circumference form and forms a kind of interconnective screen cloth style around the longitudinal axis; And

(b) at least two second pillar cellular constructions that are inserted in interconnective screen cloth style inside, each described second pillar cellular construction comprises the hoop that forms around the longitudinal axis with the circumference form, described hoop has near the inner surface of the longitudinal axis and is positioned at the outer surface of longitudinal axis far-end, is orthogonal to the longitudinal axis and is positioned at same plane substantially along the hoop surfaces externally and internally of circumference.

This expandable tubular support comprises one or more first curved structures, and this first curved structure comprises that storage (receptacle) structure holds to be used for the sealed of corresponding lock construction.This expandable tubular support comprises a kind of like this structure, this corresponding locking mechanism part that is one or more first curved structures wherein, and this first curved structure comprises silo arrangement thereon, and the corresponding locking mechanism of silo arrangement is locked.In one embodiment, the expandable tubular support also comprises one or more second curved structures, and this second curved structure comprises that silo arrangement holds to be used for the sealed of corresponding lock construction; This expandable tubular support also can comprise corresponding locking mechanism, and the corresponding locking mechanism of silo arrangement is locked.In one embodiment, the expandable tubular support comprises a kind of like this structure, and wherein the one or more silo arrangement that comprise in first curved structure are held to be used for the sealed of corresponding lock construction.

In another embodiment, the expandable tubular support comprises such structure, and wherein one or more in second curved structure comprise the corresponding locking mechanism that is used for silo arrangement, and the corresponding locking mechanism of silo arrangement is locked; Perhaps the one or more silo arrangement that comprise in second curved structure are held to be used for the sealed of corresponding lock construction.

In another embodiment, the expandable tubular support comprises such structure, and wherein one or more in first curved structure comprise corresponding lock construction, and the corresponding locking mechanism of silo arrangement is locked.

In another embodiment, but the flexible support of bio-absorbable forms a kind of like this pipe with the circumference form around the longitudinal axis, this pipe has nearly opening and opening far away, and can curl and inflatable, and having the style shape that exists with expanded form, this support comprises: by the nearly opening spiral extension of the pipe first multi-part pillar cellular construction to its opening far away; By the nearly opening spiral extension of pipe the second multi-part pillar cellular construction to its opening far away; Wherein, when each parts by the described near opening spiral extension of described pipe during to its described opening far away, the parts of each described multi-part pillar cellular construction with respect to another parts of another multi-part pillar cellular construction into about 120 ° to about 180 °.In one embodiment, support comprises a kind of like this structure, and wherein the configuration of each parts pillar cellular construction of the first multi-part pillar cellular construction is basic identical.This support also can comprise a kind of like this structure, and wherein the configuration of each parts pillar cellular construction of the second multi-part pillar cellular construction is basic identical.Perhaps, this support can comprise a kind of like this structure, and wherein each parts pillar cellular construction configuration of the first and second multi-part pillar cellular constructions is basic identical.In this embodiment, promptly wherein the configurations of components that respectively opposes of this parts pillar cellular construction between the first multi-part pillar cellular construction and the second multi-part pillar cellular construction is basic identical; And can form the alphabetical H configuration of special format, the X configuration of special format, the S configuration of special format, 8 configurations of special format or the I configuration of special format.

This support can comprise by the nearly opening spiral extension of pipe the 3rd multi-part pillar cellular construction to its opening far away.This support also can comprise by the nearly opening spiral extension of pipe the 4th multi-part pillar cellular construction to its opening far away, and by the nearly opening spiral extension of pipe the 5th multi-part pillar cellular construction to its opening far away.Each spiral of one-to-many parts pillar cellular construction can rotate along the left hand helix direction around pipe.Perhaps, this support can comprise a kind of like this structure, and wherein each spirally-wound tube of two multi-part pillar cellular constructions rotates along the right-handed helix direction.In another embodiment, at least one spirally-wound tube of two multi-part pillar cellular constructions rotates along the left hand helix direction, and another spiral rotates along the right-handed helix direction.In another embodiment, all spirally-wound tubes of multi-part pillar cellular construction rotate along equidirectional.

In another embodiment, but a kind of like this stay pipe of bio-absorbable is disclosed, it comprises the multi-part pillar cellular construction of a plurality of nearly opening spiral extensions by pipe to its opening far away, wherein when each parts by the described near opening spiral extension of described pipe during to its described opening far away, the parts of each described multi-part pillar cellular construction with respect to another parts of another multi-part pillar cellular construction into about 120 ° to about 180 °.In this embodiment, each spiral of multi-part pillar cellular construction rotates along the left hand helix direction around stay pipe; Each spiral of two multi-part pillar cellular constructions can rotate along the right-handed helix direction around stay pipe.Perhaps, this support can comprise a plurality of spirals, and wherein at least one spiral of multi-part pillar cellular construction rotates along the left hand helix direction around stay pipe, and another spiral rotates along the right-handed helix direction around stay pipe; Perhaps wherein all spirals of multi-part pillar cellular construction rotate along equidirectional around stay pipe.

A kind of flexible support also is provided, it forms a kind of like this pipe with the circumference form around the longitudinal axis, this pipe has nearly opening and opening far away, and it is also inflatable to curl, and under unexpanded form, has a style shape, this support comprises: the first sine curve formula pillar cellular construction, and it comprises a series of repetition sine curves of partly being determined by crest part and trough, described repetition sine curve extends to its opening far away by the nearly opening of pipe; And the second sine curve formula pillar cellular construction, it comprises a series of repetition sine curves of partly being determined by crest part and trough, and differing of the crest of the sine curve of the second sine curve formula pillar cellular construction and the first sine curve formula pillar cellular construction and trough is about 180 °; Wherein the second sine curve formula pillar cellular construction links to each other with first sine curve formula pillar cellular construction at two some places at least, and wherein the connection at each point place by the sinusoidal crest of the first sine curve cellular construction sinusoidal crest to the second sine curve cellular construction.

In one embodiment, this support can comprise such structure, wherein the first sine curve formula pillar cellular construction and the second sine curve formula pillar cellular construction repeat repeatedly, one by one to form support; Perhaps wherein the first sine curve formula pillar cellular construction is identical with the second sine curve formula pillar cellular construction; Perhaps wherein the first sine curve formula pillar cellular construction is different with the second sine curve formula pillar cellular construction.This support can be made as poly--lactide by Biodegradable material.In this embodiment, this support comprises such structure, and wherein the second sine curve formula pillar cellular construction is connected with first sine curve formula pillar cellular construction at three or four some places at least.

In another embodiment, but the flexible support of bio-absorbable forms a kind of like this pipe with the circumference form around the longitudinal axis, this pipe has nearly opening and opening far away, and can curl with inflatable, and has the style shape of unexpansive form, this support comprises: the first sine curve formula pillar cellular construction, and it comprises a series of repetition sine curves of partly being determined by crest part and trough, described repetition sine curve extends to its opening far away by the nearly opening of pipe; And the second sine curve formula pillar cellular construction, it comprises a series of repetition sine curves of partly being determined by crest part and trough, the crest and the trough homophase of the sine curve of the second sine curve formula pillar cellular construction and the first sine curve formula pillar cellular construction; Wherein the second sine curve formula pillar cellular construction links to each other with first sine curve formula pillar cellular construction at two some places at least, and wherein the connection at each point place by the sinusoidal crest of the first sine curve cellular construction sinusoidal crest to the second sine curve cellular construction.

In this embodiment, the first sine curve formula pillar cellular construction and the second sine curve formula pillar cellular construction repeat to form many times, one by one support; The first sine curve formula pillar cellular construction and the second sine curve formula pillar cellular construction are identical or different.This support can be made by Biodegradable material polymer for example---as poly--lactide polymer---; And comprise a kind of like this structure, wherein the second sine curve formula pillar cellular construction is connected with first sine curve formula pillar cellular construction at three or four some places at least.

One wherein tubular structure be in the embodiment of stay pipe, this stay pipe comprises a plurality of sine curve shape or zigzag pillar cellular constructions around the tubulose diameter of movement, and wherein each sine curve circulus can be continuous with adjacent sine curve circulus on one point.Adjacent sine curve/tortuous cellular construction can be more continuous.In one embodiment, the stay pipe support can be formed by two kinds of dissimilar tortuous parts, the described first tortuous parts comprise having the crest that may extend into the support whole circumference and the zigzag cellular construction/sine curve shape structure of trough, thereby even even should can keep a sine curve shape is in complete expansion when supporting structure configuration by the complications parts when supporting structure is in the configuration of complete expansion.The tortuous parts of second type also form the stay pipe support, and can insert or between the adjacent first tortuous parts, thereby when this supporting structure fully launches, the tortuous parts of second type form ring-type or cuff structure, and it can adapt to until matching with the spatial diameter of pipe that uses support fully.Ring-type (also being called ringlet) parts the tubular bracket that hoop strength improves is provided and can avoid launching after the disintegrating of support.More specifically, this embodiment provides ring or the hoop that is in swelling state, and it is in swelling state at an end of tubular device at least, is used in protection of organ space or anchor supports position.In addition, another embodiment can provide at least one other ring or hoop that is inserted in the support to be dislocated by its implantation position to avoid support.This embodiment also can provide at random a plurality of or with the ringlet of regular intervals style along the distribution of lengths of support.Under the situation of expanding stent, ringlet is designed to maximum swelling ring formation or hoop shape, perhaps is expanded to a degree to keep having more some sinusoidal shape of flexibility, littler rigid structure feature.Terminal or at support along the hoop of the existence Anywhere shape second tortuous pillar of support shaft, help avoid support by tightly pushing the organ space to, " displacement " taking place as the wall of cardiovascular." displacement " of the present invention is defined as implant and dislocated gradually by original position in the organ space.This change that can flow and be caused by the organ walls of beating and body inner fluid can be reversed by recrystallize hoop or ring entity, this entity across cavity space, press surrounding tissue and have enough elasticity and the compatibility to reduce local harmful collision.

The apparatus of each embodiment can comprise a kind of like this polymer composition, and it is designed to have flexibility under non-expansion state and has rigidity and the intensity that expand into the ratio raising with it.More specifically, embodiment preferred is designed such that the end ring that comes from the second littler tortuous pillar part of tortuosity will be extended into the hoop structure, wherein obtain the necessary intensity of pressure that opposing is used for the favourable grappling in organ transplantation space at this hoop place support polymer.The basis of this support intensity difference is present in the polymer composition, it shows the amorphous parent of loose or curled configuration, it has caused rearranging of polymer matrix but be accompanied by enhanced crystallization when carrying out cold strain, expansion or stretching, thereby has caused having improved pro rata the mechanical strength of support.

In one embodiment, this tubular bracket can comprise that the tortuous parts and can being placed in of one or more second types have between the tortuous parts of the first kind in the tubular bracket of style alternately, forms repeat pattern with the length according to the tubular bracket that obtains of wanted.In another embodiment, provide a kind of like this stent configuration, it comprises the tortuous pillar part that is connected in the stable annular element that expands and is used to effectively guarantee that support is in the snap-lock instrument of crimped position on the carrier arrangement.

In one embodiment, tubular bracket can curl and expandable structure provides being used for and uses with balloon angioplasty.Described tubulose embodiment is optional can to comprise a kind of protection mechanism, and it can be placed in each end or approaching with it of tubular structure/support.In this embodiment; protection mechanism can be on different designs and the structure and to be shaped guaranteeing that the flexiplast support is positioned on the carrier body that send the system of passing, and wherein this support can be curled on the latched position to keep support fixing on blood vessel implant carrier.This protection mechanism can comprise for example mechanical caging instrument, and as button, hook, key shape structure, engaging structure and abutment structure etc., it can be engaged with each other and guarantee that support is positioned on the carrier with a kind of configuration that tightly curls.Protection mechanism can be avoided support shifting out or the transfer on the implantation carrier in expansion process.For example, but be shaped on the locking tool structure with for example, and can be placed in an end of support or approaching with it, perhaps at its two ends or approaching with it with the form work of snap-lock instrument.This snap-lock instrument can be finger-like and extends form to slip in the end pieces that is placed in tubular configuration or the bracket component of approaching with it adjacent similar bending.Support curling transferring position down can a blocked embodiment in, this support comprises that the buckle spoon lock that is similar to dovetail head dummy perforation structure designs.

In another embodiment, the transferring position of this support under curling can be locked, by comprising the protection instrument of the buckle spoon lock design that is similar to ball-and-socket combination and groove sample integrated structure.In another embodiment, provide a kind of like this buckle spoon lock configuration, wherein the hook-shaped pillar interlocking that can arrange with adjacent opposition at the structural a series of hook-shaped pillar extensions of labyrinth ring.In other embodiments, locking mechanism can comprise that frictional force improves parts and other non-skid property and is used in the crimped stent and locks.Therefore, in the present embodiment, the mechanical interlocking feature of crimped stent can improve by the frictional force characteristic of including in the plastics composite.These frictional force improve characteristics can be added into said composition itself, perhaps is attached in the surface elements at layer form or isolated or some quarter.Suitable reagent comprises ion-type or nonionisable substance.Nonionic interacts or weak captivation is divided in the frictional force that improves support and brought into play important effect in the vector.The ion-type additive preferably concentrates on the locking surface of crimped stent to avoid undesired plasma protein qualitative response with dissolved form.

In certain embodiments, the locking tool of unfolded support can separate by the expansion gear of delivery vectors.According to its position, the lock-in feature of support can be selected to send from thoroughly curling of entire bracket structure with different rates and pass configuration and expand into and have release the process that is enough to the intracavity diameter on the implantable intravascular wall.In one embodiment, this support can be processed more being inclined to conical structure by cylindrical being changed to of homogeneous, thereby can easily install, relocate and adjust implant.For example, this support implant can be a kind of like this configuration, it comprises that bladder-type is reversible and swells or bloat tool, and this instrument is loaded onto the stent configuration of locking in the body and is placed on the target area in the following manner: the support of the locking of curling by expanding is to break latched position and to encircle into hoop shape form and engage the inner chamber circumference firmly by stretching to adjust.The airbag inflation device comprises a kind of instrument that is used to heat and/or cool off this apparatus.

A kind of medical apparatus and instruments embodiment, for example a kind of stay pipe can be made by a kind of a kind of like this material of polymer that comprises, the degraded of this polymer part with bodily tissue and fluid---for example blood vessel wall---performance " close friend " when contacting.In a specific embodiments, this medical apparatus and instruments comprises a kind ofly having enough slow degradation kinetics to avoid the polymer of tissue overload or inflammatory reaction, wherein said inflammatory reaction can cause restenosis, and for example it provides the minimum 30 days reservation of support strength clinically.In one embodiment, this medical apparatus and instruments can reach 3-4 month and still keep in position after implantation, and does not have a large amount of bio-absorbable.

In one embodiment, this implant can be carried out transition and be changed after implantation, and the flexible implant of solid when implanting becomes " rubbery state " after the implantation, thereby the flexibility of showing, but has enough elasticity and adhesive force can carry out surgical operation.

In one embodiment, the selected polymer that is used to prepare apparatus has and is suitable for implant carries out flexibility and the elasticity that zerofriction force contacts with blood vessel wall between cardiovascular pulse contraction and relaxing period.In one embodiment, this medical apparatus and instruments comprises a kind of extensile elastic support, and it has the enough pressure cvd of rigidity intensity to be able to take to fluctuate in the blood vessel.For example, the polymer selection can be according to carrying out based on the mass loss, the maintenance of mechanical performance and the assessment benchmark of tissue reaction that reduce expression with molecular weight.

In one embodiment, but this implant is by a kind of like this polymer manufacturing of bio-absorbable, but the molecular moiety of polymer that wherein should bio-absorbable comprises poly-L-lactide or poly-D-lactide as matrix polymer, is used to connect matrix polymer comprising the modified copolymer of poly-L (or D)-lactide-altogether-propylene carbonate or poly-L (or D)-lactide-altogether-6-caprolactone.These copolymers can the block copolymer form or " block " random copolymer form synthetic, wherein crystallization to take place in lactide chain length long enough.

In another embodiment, said composition comprises a kind of like this substrate copolymer, one of them part long enough and do not have sterically hindered to carry out crystallization, for example have more the L-lactide or the D-lactide of fraction, as the PEG (PEG-MME) of Acetic acid, hydroxy-, bimol. cyclic ester or Polyethylene Glycol (PEG) or single methoxy end group.

In another embodiment, said composition also can contain polymer-modified or copolymer except the substrate copolymer, they also can have the degradation kinetics of raising, for example epsilon-caprolactone copolymer part, wherein 6-caprolactone keeps amorphous, thereby makes the fragment facile hydrolysis more of gained.

In another embodiment, said composition can comprise Polyethylene Glycol (PEG) copolymer, and for example peg moiety accounts for about 1% two blocks of AB or ABA three blocks.In this embodiment, the mechanical performance of lactide (seeing Enderlie and Buchholz SFB May 2006) is maintained.In this embodiment, the introducing of PEG or PEG-MME copolymer can be used for also promoting that medicine is attached on the polymer, for example uses with drug release (drug eluding) medical apparatus and instruments.

In another embodiment, this medical apparatus and instruments comprises a kind of polymer support that contains matrix polymer, this matrix polymer comprises the combination of the polymer of the low PEG content of high molecular weight copolymer (being the 2-3IV copolymer) less than 5%, and it can make the crystallization of lactide block also give matrix polymer with suitable intensity.

In one embodiment, this polymer composition makes polymer rearrange and makes and produces crystal habit.Plastic deformation is given polymer molecule with crystallinity.The polymer of crystalline state is bigger than its amorphous polymer intensity.In comprising the stay pipe embodiment of circulus, circulus or ringlet can be a kind of like this materials behavior, it is bigger than the segmental inherent strength of sine curve stay pipe, its can improve medical apparatus and instruments mechanical performance, improve processing conditions and the crosslink part crystallization be provided the possibility of---for example heat cross-linking---.

Other embodiment disclosed herein comprises the degradation time that shortens polymer in the compositions, but for example a kind of medical apparatus and instruments comprises a kind of polymer of bio-absorbable of the degradation kinetics with raising.In this embodiment, raw material can be lower molecular weight compositions and/or can use matrix polymer more hydrophilic or that hydrolytic chain is easy to decompose.

In another kind of apparatus embodiment, this medical apparatus and instruments comprises a polymeric blend that contains labelled molecule, for example a kind of radiopaque material of described labelled molecule, fluorescent material or luminescent substance, it can be used for after medical apparatus and instruments is implanted in patient's body it being detected or discerning.For example, the chemical compound that can be used as labelled molecule comprises iodine, phosphorus, fluorophor etc.Medical apparatus and instruments for example uses the medical apparatus and instruments of fluoroscopy, X ray, MRI, CT technology etc., can be used for detecting the radiopaque material.

In this embodiment and other embodiment of the present invention, this medical apparatus and instruments can comprise filler and one or more drug substances that are used for local application.This medical apparatus and instruments can comprise that for example a kind of biological preparation, medicament are as a kind of entrapped drug (it can be used for, and the part is sent and passed and treat---as vascular wall tissue and inner chamber---).

In another embodiment, provide a kind of supporting structure that comprises the core degradation plan, more specifically, this plan can slowly discharge the medicine that is used for the treatment of and prevents tissue inflammation and platelet aggregation simultaneously.This polymer composition or blend provide the degraded of original position homogeneous, thereby have avoided the bulk or the particle release of polymer.

In another embodiment, this polymer composition is used for making the intravital medical apparatus and instruments of implantation patient.But this medical apparatus and instruments comprises the support with biodegradable bio-absorbable and nontoxic performance, and includes but not limited to stay pipe, stay pipe graft, blood vessel synthetic graft, conduit, vascular shunt device, valve etc.But the support of biocompatible and bio-absorbable can be used in particular for treating coronary artery.For example, supporting structure can be by a kind of medicine that contains a kind of matrix polymeric material, at least a local delivery and at least a adhering to or the compositions manufacturing of embedding identification tag or extrude.

In another embodiment, disclose a kind of method for the treatment of angiopathy, this method comprises: use a kind of such medical stand or apparatus to the people who suffers from angiopathy, but it comprises a kind of structure of the polymer manufacture by the biocompatibility bio-absorbable.

Description of drawings

The figure that provides with this paper has described as the described embodiment of illustrative examples, does not think that these examples limit the present invention by any way.

Fig. 1 is a computer mould graphoid, but it illustrates the partial view of embodiment of the medical apparatus and instruments of a bio-absorbable, illustrates stent strut fragment, nested cuff structure, end ring, locking mechanism and interconnective " H " position.

Fig. 2 is the computer generation figure at a kind of embodiment, but this embodiment comprises a kind of bio-absorbable stay pipe design that has slightly under the expansible configuration states that is in, and shows nested hoop or ring structure, end ring, tortuous pillar cellular construction and locking mechanism.

Fig. 3 A has described a kind of computer mould graphoid, but it illustrates a kind of bio-absorbable stay pipe support of premature expansion, the figure shows alternative ring or cuff structure and a kind of tortuous pillar part cellular construction and locking mechanism.Fig. 3 B is the stay pipe support identical with Fig. 3 A, and it shows the ring plate section that is under the different stress.

But Fig. 4 A is the plane graph of an embodiment of a stay pipe carrier unit structure that shows a kind of bio-absorbable, but it has described to have the plane graph of the bio-absorbable support of multiple S shape pillar cellular construction feature, and other design shown in wherein S shape can be used replaces.Fig. 4 A also shows nested hoop/ring structure.Fig. 4 B is another embodiment of plane configuration, and its example has gone out nested ring component, and wherein this stay pipe corbeling can replace with the design that 8 places are contained.Fig. 4 C is the plane graph of one embodiment of the invention, and wherein this construction unit forms helicoidal structure.Fig. 4 D shows the hoop that has shown in the form of manufacturing or the part stay pipe structure of ring structure parts and bracket component.Fig. 4 E shows the stay pipe structure of Fig. 4 D that is in the demi-inflation configuration.Fig. 4 F shows the stay pipe structure of Fig. 4 D that is in expanded configuration.

But Fig. 5 has described the oblique view of bio-absorbable stay pipe embodiment, and it shows the tortuous pillar fragment of sine curve style.

Fig. 6 A has described expansion hoop in a kind of stay pipe embodiment or ring and complications or sine curve (6B) but the partial top view of the bio-absorbable pillar part of formula.But Fig. 6 C shows the hoop or the ring component of bio-absorbable stay pipe, and it shows radial/lateral load and how to be distributed on the whole ring structure.

Polymer fiber in the embodiment of bio-absorbable medical apparatus and instruments is arranged and this is arranged in how to carry out plastic deformation when being subjected to stress but Fig. 7 A-7C shows.Fig. 7 A shows the amorphous state of the polymer composition that is used to prepare this apparatus.The polymer fiber that Fig. 7 B shows in the demi-inflation configuration is arranged, but the embodiment of Fig. 7 C shows a kind of bio-absorbable stay pipe of embodiment when the expanding crystal state of fiber.

But Fig. 8 A shows the plane graph of bio-absorbable stay pipe support embodiment, and the stay pipe support of this embodiment comprises the zigzag pillar part of structure, nested hoop/ring component and has end ring at the opening part of stay pipe.Fig. 8 B is the plane graph of the stay pipe holder part of Fig. 8 A, and it shows the zigzag pillar part of structure that forms the stay pipe support, nested hoop/ring component and syndeton.The state of stay pipe support when making illustrates, and shows the nested ring structure of multiple configuration, and zigzag parts of structure and being connected with the alphabetical H shape of special format of binding round between the parts.Fig. 8 C shows Fig. 8 B fragment of expanded configuration.But Fig. 8 D, 8E and 8F are the plane graph of bio-absorbable stay pipe cradle wall, and it shows other design implementation schemes of link, and they can be replaced between tortuous pillar part.But Fig. 8 G is the plane graph of bio-absorbable stay pipe cradle wall, its show another design implementation scheme of support and hoop/ring element structure and this design how the change by replaceable link to change the flexibility of this stay pipe support.Fig. 8 H shows the stay pipe support of manufacturing, and it shows the nested hoop/ring structure that inserts between the tortuous pillar part.Fig. 8 I is Fig. 8 H under the demi-inflation configuration states, and Fig. 8 J is identical with the 8H that is in expanded configuration, and Fig. 8 K is in adequately expanded configuration.

But Fig. 9 A has described the plane graph of bio-absorbable stay pipe support, and it shows the pillar part, end ring parts of multiple parts, nested hoop/ring structure parts, complications/sine curve shape and join through after changing wherein each parts and is the cyclic syndeton of o-.Fig. 9 B shows the oblique view of stay pipe structure stand shown in Fig. 9 A of expanded configuration.

But Figure 10 A shows the link as the bio-absorbable support of being painted among Fig. 9 A, and it shows the connection status of manufacturing; Figure 10 B and 10C are in the demi-inflation state and Figure 10 D is in abundant swelling state.

But Figure 11 A has described the plane graph of another unexpansive bio-absorbable stay pipe support Design, and it shows another cellular construction that connects between the pillar part and comprises end ring structure.Figure 11 B is Figure 11 A of expanded configuration.But Figure 11 C example has gone out to be in the stay pipe structure that is placed in the bio-absorbable shown in Figure 11 A on the balloon catheter under the expanded configuration.

But Figure 12 A has described the plane graph of another embodiment of bio-absorbable stay pipe supporting structure, and it shows the pillar part that is under the expanded configuration and another design of hoop/ring component.But Figure 12 B is the bio-absorbable stay pipe structure that is placed in Figure 12 A on the balloon catheter that is in swelling state.

But Figure 13 A shows a kind of like this bio-absorbable stay pipe support embodiment, and it comprises the radiopaque mark structure on the link that places between end ring position and the pillar fragment support.Figure 13 B shows a kind of like this embodiment, and wherein the radiopaque material is settled with the diagonal style, is used for after this apparatus is implanted it being carried out radiography and discerning.

But Figure 14 A-14D shows the sectional view of another embodiment of the isolated labelling indicating structure of bio-absorbable stay pipe support.

But Figure 15 A and 15B also show the position that indication radiopaque label is placed in the stay pipe support embodiment of bio-absorbable, but and the radiography figure of Figure 15 C for the radiopaque labelling indicant in the bio-absorbable stay pipe pillar embodiment is carried out.

Figure 16 A shows the plane graph of an end of the stay pipe embodiment that is in expanded configuration, and described stay pipe embodiment comprises the tortuous parts of end ring parts, locking mechanism and stay pipe pillar.Figure 16 B is the curled configuration of stay pipe support shown in Figure 16 A.Figure 16 C shows expansion stay pipe support, wherein shows stress distribution.But Figure 16 D shows the fragment of bio-absorbable stay pipe support embodiment, and it shows nested hoop/ring structure, the tortuous fragment of stay pipe and locking mechanism or fixed part (retention feature), and it can carry out the change of design aspect at joint.

Figure 17 A and 17B have described the plane graph of other embodiments under swelling state of stay pipe support, and show the locking mechanism and the end ring structure of the disengagement of its end.

But Figure 18 A-18F shows another embodiment of the stay pipe support of bio-absorbable, its with plane graph and oblique view show the end ring position of this apparatus and be in and break away from and the locking mechanism of bonding station.Figure 18 G shows a kind of like this embodiment, and wherein the stay pipe support is placed on the balloon catheter and locking mechanism engages so that stay pipe is in the stay pipe main body plane with the homogeneous configuration and maintains on the conduit.Figure 18 H is the front view of the stay pipe support of Figure 18 G, and it shows circular conduit, end ring and air bag.

Figure 19 A has described the plane graph of stay pipe support embodiment, and it shows the alternative embodiment of locking mechanism of the stay pipe end of manufacturing.Figure 19 B has described to be in Figure 19 A of crimped position, and it shows the locking mechanism of joint.Figure 19 C shows the amplification view of the locking mechanism that is in crimped position, and Figure 19 D shows its demi-inflation configuration, and Figure 19 E shows the oblique view of the end ring that locking mechanism partly engages; Figure 19 F shows rolled state, and Figure 19 G shows the state that is placed on the balloon catheter.

But Figure 20 A has described to be in the plane graph of another design of locking mechanism in the embodiment of bio-absorbable stay pipe of expanded configuration; Figure 20 B has described its curled configuration.Figure 20 C is the plane graph of end fragment, and it shows snap lock fixed end when being in curled configuration, snap lock fixed end when Figure 20 D shows its expanded configuration.Figure 20 E and 20F represent to be in respectively the oblique view of stay pipe support of Figure 20 A-20F of expanded configuration and curled configuration.Figure 20 G shows the stay pipe support that is placed on the balloon catheter.

But Figure 21 has described to place the photo of the bio-absorbable stay pipe support of the manufacturing between people's thumb and the forefinger, and it shows the flexibility of this apparatus.

The specific embodiment

Herein disclosed is new structure member, and the new compositions that can be used for preparing described new construction parts.Embodiment of the present invention can be used for treating multiple disease and disorder.

In recent years, brought into use the metallic support pipe to remove the inner chamber of the obstruction of blood vessel system with help.Yet the usefulness of the metallic support pipe implant of implantable intravascular tremulous pulse is owing to some disadvantageous result reduces.For example, because described stay pipe has shown the tendency that stimulates wound scar tissue or restenosis to form, wherein said wound is to cause in angiosomes launches.This effect becomes more unfavorable in the treatment of using narrow tube.In addition, importantly during inserting, stay pipe to avoid the arterial wall damage.The target of these factors (although difficult slightly control in first kind of situation) is to attempt to be reduced in to cause too much grumeleuse and synulotic mechanical reason in the intravascular space.

The stay pipe structure generally includes a large amount of tortuous cellular constructions.The implication of " complications " is for to move along the collinear route of non-strictness.Owing to need have unexpansive form so that stay pipe is easily inserted its biotic environment (such as but not limited to vascular system), the tortuous cellular construction that constitutes stay pipe is actually sine curve usually, that is to say the arrangement with multiple crest and trough.Thereby common described sinusoidal configuration by standardization make each crest or trough apart from the range finding of center line from generally identical.The implication of " non-sinusoidal cuve " is a kind of like this style, and it does not have the sequence of multiple crest and trough and do not have a series of range findings apart from center line and does not have a series of range findings apart from center line from the identical sloping portion of cardinal principle from identical rising part substantially yet.The feature of stay pipe can be has following three kinds of different configurations: non-expansion state (being prepared into), rolled state (compressive state of comparing with non-expansion state) and swelling state (when implants in vivo launches).

Configuration disclosed in this invention is not limited to by any certain material manufacturing, but but described in certain embodiments configuration by plasticity Framework construction flexible, elastic bio-absorbable.But the disclosed embodiments of the present invention example gone out multiple shape, style and the feature made by Bioabsorbable polymeric and polymer composition bio-absorbable and expandable stent.Support balance in advantageous embodiment elasticity, rigidity and flexible performance, have more biocompatibility, more difficult formation thrombosis and immunogenicity than polymeric medical device of the prior art simultaneously.Described embodiment can be provided for placing on the carrier when curling and avoid the apparatus displacement or the instrument of change position when expansion places organ space alive.The stay pipe implant can be used the inflatable medical apparatus and instruments of gasbag-type, and it comprises steam capsule or non-steam capsule.

Referring now to accompanying drawing, Fig. 1 is a computer mould graphoid, but it illustrates the partial view of embodiment of the medical apparatus and instruments of a bio-absorbable that is in unexpansive form, illustrate stent strut fragment 17, nested cuff structure 14 and end ring 16, both include the not structure in same plane, locking mechanism 18 is connected on another locking mechanism (not shown), and interconnects " H " position 15 and have ring expansion through hole 11 at nested cuff structure 14 places.

Fig. 2 is the computer generation figure at a kind of embodiment, but this embodiment comprises a kind of bio-absorbable stay pipe design that has slightly under the expansible configuration states that is in, show the nested cuff structure 14 (or ring structure) and the end ring 16 that are positioned at same plane on the present at present roughly body, tortuous pillar cellular construction 17, and and with isolating another locking mechanism 18 of another locking mechanism.Shown in expansion through hole 11 in this expanded configuration, be drawn into an oblong hole.

Fig. 3 A has described a kind of computer mould graphoid, but illustrates a kind of bio-absorbable stay pipe support of premature expansion, the figure shows alternative ring or cuff structure and a kind of tortuous pillar part cellular construction 17 and locking mechanism 18.Fig. 3 B be with Fig. 3 A in identical stay pipe support, it shows the ring plate section that is under the different stress.Under both arbitrary situations, comprise that the structure of each ring or hoop roughly is positioned at same plane.

But Fig. 4 A is the plane graph of an embodiment of a S shape stay pipe carrier unit structure 15 that shows a kind of bio-absorbable, and other design shown in wherein S shape can be used replaces.Fig. 4 A also shows nested hoop/ring structure 14.Fig. 4 B is another embodiment of plane configuration, and its example has gone out nested ring component 14, and wherein this stay pipe corbeling can replace with any design that 8 places comprise.Fig. 4 C is the plane graph of the unexpansive support embodiment of anticipatory remark invention, and wherein structure sine curve cellular construction 17 is forming helical form style structure 9 (shown in diagonal styles in the plane graph) in the total.Fig. 4 D shows that Fig. 4 C support forms has the unexpansive stay pipe structure 16 of part with hoop or the ring structure parts 14 and the bracket component of manufacturing form.Fig. 4 E shows the stay pipe structure of Fig. 4 D that is in the demi-inflation configuration.Fig. 4 E show be in having of expanded configuration be positioned at substantially same plane the stay pipe structure of Fig. 4 D of extended loop.

But Fig. 5 has described the oblique view of the stay pipe embodiment of the bio-absorbable that do not expand, and it shows the tortuous pillar fragment 22 and the end ring 23 of sine curve style.

Fig. 6 A has described the expansion hoop of stay pipe embodiment or the partial top view of ring, and Fig. 6 B shows described hoop or ring when unexpansive, shows in the drawings by zigzag sine curve (6B) but the stay pipe embodiment that the bio-absorbable pillar part of shape constitutes.But Fig. 6 C shows the hoop or the ring component of bio-absorbable stay pipe, and it shows radial/lateral load and how to be distributed on the whole ring structure.Go out as shown, this structure provides better power to distribute, thereby makes described stay pipe be in open state under the active force that alternate manner may cause this stay pipe to be out of shape.

Polymer fiber in the embodiment of bio-absorbable medical apparatus and instruments is arranged and this is arranged in how to carry out plastic deformation when being subjected to stress but Fig. 7 A-7C shows.Fig. 7 A shows the amorphous state of the polymer composition that is used to prepare this apparatus.The polymer fiber that Fig. 7 B shows in the demi-inflation configuration is arranged, but Fig. 7 C shows the crystal state of bio-absorbable stay pipe fiber when expanding of an embodiment, and the stay pipe of this embodiment is made up of raceme or three-dimensional complex polymeric compositions.

But Fig. 8 A shows the plane graph of unexpanded bio-absorbable stay pipe support embodiment, and this embodiment comprises the zigzag pillar part 17 of structure, nested hoop/ring component 14, and has end ring 16 at the opening part of stay pipe.Fig. 8 B is the plane graph of a part of the stay pipe support of Fig. 8 A, and it shows the zigzag pillar part 17 of structure that forms the stay pipe support, nested hoop/ring component 28,30 and syndeton.The stay pipe support illustrates with the state of making, and shows the nested ring structure 28,30 of multiple configuration.With regard to the tortuous parts of structure with regard to being connected between the hoop parts, the visible alphabetical H shape of special format.Fig. 8 C shows Fig. 8 B fragment of expanded configuration.But Fig. 8 D, 8E and 8F are the plane graph of bio-absorbable stay pipe cradle wall, and it shows other designs 17 of junction point between tortuous pillar part 17 and the ring structure 15 (nested) and 16 (end-rings structure).But Fig. 8 G is the plane graph of bio-absorbable stay pipe cradle wall, the flexibility that it shows the change that another design implementation scheme of pillar and hoop/ring element structure and this design how can be by other links and then changes this stay pipe support.Fig. 8 H shows the stay pipe support of manufacturing, and it shows the nested hoop/ring structure that inserts between the tortuous pillar part.Fig. 8 I is Fig. 8 H that is in the demi-inflation configuration, and Fig. 8 J is identical with the 8H that is in expanded configuration, and Fig. 8 K is in adequately expanded configuration.

But Fig. 9 A has described the plane graph of bio-absorbable stay pipe support, its show multiple parts, nested hoop/ring structure parts 28, complications/sine curve shape pillar part 38, end ring parts 16 and through after changing be the cyclic syndeton 6 of o-in each parts joint.Fig. 9 B show as among Fig. 9 A with the oblique view of the stay pipe structure stand shown in the expanded configuration.

But Figure 10 A shows the syndeton 6 as the bio-absorbable support of being painted among Fig. 9 A, and it shows the connection status of manufacturing; Figure 10 B and 10C are in the state of demi-inflation, and Figure 10 D is in abundant swelling state.Go out as shown, flexible void shape changes when support expands.

But Figure 11 A has described the plane graph of another unexpansive bio-absorbable stay pipe support Design, and it shows another cellular construction that connects between the pillar part and comprises end ring structure.Figure 11 B is Figure 11 A of expanded configuration.Figure 11 C shows the unfolded Figure 11 A on swelling gasbag formula conduit that is under the swelling state.

But Figure 12 A has described the plane graph of another embodiment of bio-absorbable stay pipe supporting structure, and it shows another design that being used under the expanded configuration comprises the pillar part of hoop/ring component 14 and 16.But Figure 12 B can be the bio-absorbable stay pipe structure that is placed in Figure 12 A on the balloon catheter that is under the expanded configuration.

But Figure 13 A shows a kind of like this bio-absorbable stay pipe support embodiment, and it comprises the radiopaque mark structure 65 of the link that places between end ring position and the pillar fragment.Figure 13 B shows such embodiment, and wherein the radiopaque material is settled with diagonal style 65 ', is used for after this apparatus is implanted it being carried out radiography and discerning.

But Figure 14 A-14D shows the sectional view of other embodiments of the isolated labelling indicating structure of bio-absorbable stay pipe support.Go out as shown, separation marking can be placed in that stay pipe (14D) is gone up or recess (14B) in or in a plurality of through hole (14A and 14C).

But Figure 15 A and 15B also show the position of indication radiopaque label 65 in the stay pipe support embodiment of bio-absorbable.The nearly radiography of Figure 15 C for but the radiopaque labelling indicant in the bio-absorbable stay pipe pillar embodiment is carried out.

Figure 16 A shows the plane graph of an end of the stay pipe embodiment that is in expanded configuration, and described stay pipe embodiment comprises the tortuous parts 17 of end ring parts 16, locking mechanism 75 and stay pipe pillar.Figure 16 B is the curled configuration that has the stay pipe support of interlocking locking mechanism 75 shown in Figure 16 A.Figure 16 C shows expansion stay pipe support, and it shows stress distribution, and shows the separation of locking mechanism 75 when stay pipe is in expanded configuration.But Figure 16 D shows the fragment of bio-absorbable stay pipe support embodiment, and it shows nested hoop/ring structure 14, the tortuous fragment 17 of stay pipe and locking mechanism 11 or fixed part, and it can carry out the change of design aspect at joint.

Figure 17 A and 17B have described the plane graph of other embodiment under swelling state of stay pipe support, and show in the locking mechanism 75 and the end ring structure 16 of the disengagement of its each end.Go out as shown, locking mechanism 75 is that the buckle of convexconcave part connects.

But Figure 18 A-18F shows the plane graph and the oblique view of another embodiment of the stay pipe support of bio-absorbable, its show the end ring position of this apparatus and be in and break away from and the locking mechanism 75 of bonding station.Locking mechanism 75 in the described embodiment comprises the buckle ball joint.Figure 18 A, 18D and 18E show disjunct locking mechanism 75.Figure 18 B, 18C and 18F show the locking mechanism 75 that is in the lock state.Figure 18 G shows a kind of like this embodiment, and wherein the stay pipe support is placed on the balloon catheter 60 and locking mechanism engages so that stay pipe is in the stay pipe main body plane with the homogeneous configuration and maintains on the conduit.Figure 18 H is the front view of the stay pipe support 16 of Figure 18 G, and it shows circular conduit 60, end ring 16 and air bag 70.

Figure 19 A has described the plane graph of stay pipe support embodiment, and it shows another embodiment of each locking mechanism of holding 80 of stay pipe of manufacturing.Figure 19 B has described to be in Figure 19 A of crimped position, and it shows the locking mechanism 80 of joint.Figure 19 C shows the amplification view of the locking mechanism that is in crimped position, and Figure 19 D shows the not lock-out state of its demi-inflation configuration.Figure 19 E shows the oblique view of the end ring of locking mechanism 80 parts joint; Figure 19 F shows the state and Figure 19 G that are in crimped position and shows the state that is placed on the balloon catheter.

But Figure 20 A has described to be in the plane graph of another design of locking mechanism in the embodiment of bio-absorbable stay pipe of expanded configuration.Figure 20 B has described the same level figure under the curled configuration.Figure 20 C is the plane graph of end fragment, and it shows the snap lock fixed end that is in curled configuration.Figure 20 D shows the end fragment of Figure 20 C when expansion causes locking mechanism 80 to unlock.Figure 20 E and 20F have described to be in the oblique view of stay pipe support of Figure 20 C of the locking mechanism with non-locking 90 under the expanded configuration respectively, and the oblique view of stay pipe support of Figure 20 C that is in the locking mechanism with locking 90 of curled configuration.Figure 20 G shows the stay pipe support of Figure 20 A-20F that is placed on the balloon catheter.

But Figure 21 has described to place the photo of the bio-absorbable stay pipe support of the manufacturing between people's thumb and the forefinger, and it shows the flexibility of apparatus.As can be seen, can there be sizable flexibility.

Because lack mass density or do not have signal, the polymeric implant of embodiment can detect hardly.Therefore, described embodiment can comprise the radiopaque labelling, as radiopaque point.Described point can by paste radiopaque material is applied among these stent strut parts or on riveting shape recess or storage produce.As directed, the regular style that is deposited on the radiopaque point on this support will advantageously help to make the lonizing radiation of described implant position to detect easily.

In a support embodiment, this support comprises a polymer support pipe that can curl, and it can be inserted into by the air bag delivery system that is used for the blood vessel implantation.Yet the flexible plasticity of this stay pipe support can cause being used for the blood vessel insertion or sending the curled configuration on the carrier system of passing to loosen.Therefore, this crimped stent is easy to take place " displacement ", removes or becomes loose fully from gasbag-type carrier destination locations.Therefore; in preferred embodiments; provide a kind of protection mechanism to such polymer apparatus such as stay pipe, be used for protecting to avoid the support opening that when being placed in or being installed on the delivery system and during the apparatus that curls is expanded to the position that pipe wants, meets accident.Herein disclosed is the kinds of protect mechanism that can use with medical apparatus and instruments.Protection mechanism can be designed to far away adjacent with proximal loop pillar (the second tortuous pillar part) with circumference.In specific embodiments, this support has now equipped locking tool so that curved structure remains on the position that safety clamps, thereby avoids structural distortion and be used for launching safely of this apparatus.In addition, locking device can avoid the curled configuration of plasticity support to unclamp from carrier system during operation.Locking mechanism is influenced by relevant design of structure and/or the frictional behavior that is added, and locking mechanism can be activated by mutual pressure fitted.According to a kind of embodiment, the frictional force of locking mechanism can be influenced by the plastic composition of selectivity modification, and wherein ion-type or nonionic additive materials can be used for guaranteeing the curled configuration of support.

In specific embodiments, this support uses multiple design---comprise be positioned at or near the snap part of far-end and near-end---is locked in the support that is in crimped position on the carrier body of delivery system.In this embodiment and other embodiment, can design one or more buckle structures, place tortuous pillar part terminal of supporting structure or also can place some repeatable position in the supporting structure.As wanting in the zigzag configuration, locking mechanism has improved the retentivity of stay pipe.Adjacent snap-lock parts are designed to successive, perhaps are attached on second complications or the ring/cuff structure or on its part; And be shaped effectively engaging and to lock each end of this support apparatus that is in crimped position, thereby provide enough retentivitys to make support remain on and keep its diameter homogeneous along the position of the longitudinal axis of apparatus.In certain embodiments, after apparatus expanded, terminal tortuous parts can be formed for improving---for example stay pipe---hoop strength stretch ring fully.

As previously discussed, can provide a kind of structure locking tool of key configuration component form to this apparatus, wherein this design class is similar to buckle ball cover maqting type interlocking instrument; The nested tortuous modular construction of one or more hoops that are used to form expanded configuration or ring-type style is provided in one embodiment.

This support embodiment can constitute in many ways.For example, the ring-like latched position in end that a kind of support embodiment can be used the buckle form, wherein bracket shape or finger strut parts are when cooperating tightly on adjacent counter-pressure pillar surface when the zigzag configuration of stay pipe is locked.In another embodiment, locking tool comprises that a kind of like this finger-like bracket extends, and it slides against in the buckle mode on the curvature match surface parts of adjacent part of plasticity stent strut parts with engaging.In this embodiment, detent mechanism breaks or rubbing device works as a kind of, and it has produced enough frictional force so that bracket end remains on crimped position.Another alternative locking tool illustrates with the snap-lock instrument of the ball joint under the lock-out state.

Another kind of alternate mechanism is a kind of like this snap lock means, and wherein the otch acceptance division that forms on the adjacent struts parts of this bracket embodiment utilization holds the tip member of bracket.

In one embodiment, the structure locking tool of this medical apparatus and instruments can be designed to key or ball joint configuration, and wherein the bracket hook interlocking instrument of relative orientation is in locking and latched position not.

In another embodiment, can provide the structure locking tool that is shaped with the key configuration to this medical apparatus and instruments, wherein this design class is like buckle dovetail head dummy interlocking instrument.

This locking tool can with near or the form of snap features that is positioned at the one or both ends parts of support entity provide, thereby make it during being delivered to the therapeutic goal zone, can remain on the original position on the carrier instrument, unless up to or expansion when implanting during the expansion carrier system stimulated to break away from this apparatus.During launching, locking mechanism can break away from each other uniformly.In one embodiment, thus this locking mechanism can fully stretch and makes and implanting---for example the chamber wall of blood vessel or other target area---that the back is at the connection regulator ring formation at the place, one or both ends of vertical tortuous bracket component.

In an embodiment structure, tortuous pillar replaces each other.The position that the special connector of the first tortuous pillar and second complications or the pillar part both of micro state multiple shapes by being positioned at the cross point place between adjacent struts remains in curled configuration each other and expansion or implants configuration.Each described cross-connect or its selected number are reusable.These links can keep the tortuous pillar of support embodiment to be in regular interval location.These adapters are intended to stand passed round/insertion apparatus and tighten tight crimped position again to the variation of spreading configuration to being positioned to send by initial tubular.The stretching, extension compressing of described stay pipe support and crystallization pillar part and hoop/ring, forming ring-type and integral body is cylindrical or taper.Pillar link or adapter can be arranged to stablize and to be connected adjacent tortuous pillar part by repeat pattern.This design is intended to make the tortuous pillar of resilient flexibility to remain in the tubular bracket structure.

In another embodiment, provide a kind of cooling of tool or condition, be used for the curling carrier system that locks is fixed and be stabilized in to the plasticity support, thereby the reliability of system is delivered in raising.

In another embodiment, this medical apparatus and instruments comprises a kind of like this polymer scaffold, and it can be upon deployment---for example when airbag inflation---effects of strain under orientation and/or crystallization, to improve its mechanical performance.These mechanical performances include but not limited to resistance, retroaction, the elasticity to compression.

In another embodiment, this medical apparatus and instruments is by degradable polymer or polymer composition preparation in vivo, the fluorinated polymer that is obtained by described degraded comprises having that the host is had utmost point reduced immunogenicity or essentially no immunogenic " close friend's " or biocompatible chemical compound, and for example not having remarkable granulation tissue can be stimulated to grow in blood vessel wall.

In another embodiment, this medical apparatus and instruments comprises the polymer with slow degradation kinetics, and this can be avoided tissue overload or other inflammatory reaction at the implantation site place.

In one embodiment, the I of medical apparatus and instruments has is enough to resist displacement or the degraded after the implantation clinically and causes 30 days original positions of endothelialization to keep.

But exemplary medical apparatus and instruments structure formation changes implant site and consistent with it ability to provide, and the normal restorative ability that makes local organization is provided.For example, this medical apparatus and instruments can be become " rubber-like " by the solid polymer status transition, and makes surgical operation easier with respect to for example metallic support pipe such as rustless steel stay pipe.Deformation state is high more, and the intensity of giving these apparatus structure parts is high more.

In certain embodiments, this polymer composition can comprise the matrix polymer of the amount existence that can account for the about 70 weight %-95 weight % of compositions or about 70 weight %-80 weight %.

In one embodiment, this polymer formulations can comprise the poly-L-lactide (about 2.5-3IV) and poly-L-lactide-common-TMC (70/30w/w) (1.4 to 1.6IV) of about 70 weight %.

In another embodiment, this polymer formulations comprise the poly-L-lactide of three blocks of 70 weight %-altogether-PEG (99/01) (2.5-3IV) with poly-L-lactide-altogether-TMC (70/30w/w) (1.4 to 1.6IV).

In one embodiment, this polymer composition can comprise the poly-L-lactide of diblock of a kind of about 70 weight %-altogether-PEG-MME (95/05) (2.5-3IV) with the preparation of poly-L-lactide-altogether-TMC (70/30w/w) (1.4 to 1.6IV).

An embodiment of a biodegradable medical apparatus and instruments comprises a kind of like this matrix polymer, and it for example comprises poly-L-lactide or poly-D-lactide, modified copolymer poly-L (or D)-lactide as indicated above-altogether-propylene carbonate or poly-L (or D)-lactide-altogether-6-caprolactone.

Polymerization is preferably undertaken by the block polymerization of D and L isomeric forms, thereby obtains a kind of like this polymer raceme part, and it has strengthened by the transformation of general amorphous configuration to the polymer moieties crystal rearrangement that causes with expand relevant stretching, extension or strain.Mechanical performance correspondingly changes to the rigidity that hoop shape is extended by the flexibility of can curling, and occurs in the ring of settling with end of most particularly above-mentioned change nested arrangement on the second tortuous pillar or the expansion process of hoop.

In one embodiment, pharmaceutical composition can be sneaked into polymer by for example following mode: said composition was mixed before the apparatus extrusion molding with polymer, or said composition is grafted on the polymer active site, or said composition is coated on the apparatus.

Medical apparatus and instruments can comprise any polymeric medical device that can be used for implanting, and comprises stay pipe, graft, stay pipe graft, synthetic vessel graft, diverter, conduit etc.

Exemplary medical apparatus and instruments can be a stay pipe, and it is shaped with first complications/sine curve modular construction and has nested second parts that comprise the circulus parts in a large number when expanding.This stay pipe also can comprise connected structure, is used for help curling and keeps rolled state entering for example tremulous pulse or vein, and can original position expand and adapt to intravascular space, to rebuild the seriality of blood vessel in impaired site.In another embodiment, this stay pipe can be shaped having different arrangements, cellular construction or design, thereby it can be curled when packing into, and under physiological condition in case launch inflatable, have flexibility, but also have compression resistance force or resilience force.In addition, the expansion implant can show mechanical performance, for example rigidity to a certain degree and flexibility accordingly, thus avoid dislocation or displacement.

Different biodegradable polymer support pipes and/or support tube wall embodiment have different configurations.For example, this stay pipe is a kind of tubular structure that comprises a kind of like this support, and wherein pillar part is designed to make blood flow to cross open space between each parts.Especially, thus this complications pillar is made the major part in the adjacent tissue surface still can keep in touch with blood so at interval., specific stay pipe design part comprises the different radially and vertically parameters that depend on the size for the treatment of unfolded stay pipe.Can change the stay pipe structure, for example bifurcated or shaping are so that further be deployed into other blood vessel away from initial implant site.

Stay pipe can contain the flexible support of the homogeneous of useful lateral branching modification.Therefore, after this stay pipe launched in position at first, second stay pipe can be inserted into by the internal chamber wall of first stay pipe.

In one embodiment, can modify this medical apparatus and instruments, perhaps be better than the effect of definite life-time service (6 months or 2 years) so that it comprises that a kind of material radiopaque or semi-transparent ray is used for surveying its position after expansion.Can use dissimilar modifications, for example support scatters or the some labelling.Therefore, this radiopaque material can directly be blended in the initial plastic composition with the form of mixture or with the form of covalent bonding component.Perhaps, this radiopaque material can be positioned on the support or within a plurality of concrete some storage of regular distribution in.Perhaps the material of radiopaque or semi-transparent ray can be used as the part use of the shallow layer on the support.

Therefore, the comparison and detection enhancing of anatomic implants matter being carried out by electron-dense or X-ray refraction label institute is favourable.Described label can be present in the biodegradable some storage that is full of the radiopaque compositions that is prepared by known materials, with the refraction X ray, thereby becomes as seen in photographs.Suitable material includes but not limited in the radiopaque chemical compound or microgranule that are embedded in biodegradable part of 10-90%, particularly places the form of the paste composition of the multiple cup-shaped storage that is arranged in preformed polymer support pillar part.

The radiopaque chemical compound can be selected from the chemical compound of roentgenopaque chemical compound or refraction X ray, as metallic particles or salt.Suitable metal marker thing can comprise ferrum, gold, collargol, zinc, the magnesium of pure form or organic compound form.Other radiopaque material is tantalum, tungsten, platinum/iridium or platinum.The radiopaque label can be made up of the bonding agent of one or more above-mentioned biodegradable polymers, and described polymer is PLLA, PDLA, PLGA, PEG etc. for example.In order to obtain suitable marker material blend, dicyandiamide solution comprises two or more among acetone, toluene, the DMSO etc.In addition, the label storage can be used for placing the anti-inflammatory agent that is selected from families such as PPAR agonist, steroid, mTOR inhibitor, neurocalcin inhibitor.In an embodiment that contains the radiopaque label, iron containing compounds or to seal the granule and the PLA polymer matrix of ferrum crosslinked is to produce injectable or otherwise to place the pasty masses of the contained suitable hollow storage of polymer pillar part.Even it is positioned at the width of stent strut parts to make described cup-shaped storage form such size.Heavy metal and heavy rare earth element are used for multiple chemical compound, for example ferrous salt, organic iodine material, bismuth or barium salt etc.Other embodiments can be utilized natural ferrum granule such as the ferritin of sealing, and it can be also further crosslinked by cross-linking agent.In addition, the ferritin colloid can constitute by the glutaraldehyde cross-linking with low concentration (0.1-2%).The radiopaque label can be used and remain in the polymer in many ways.For example, the fluid of this label or cream mixture can be filled in the syringe and slowly be injected into the preformed hole or the cupping place of biodegradable stay pipe support by needle point.Solvent contained in the fluid mixture can be attached to marker material on the cavity walls.The stay pipe that contains the radiopaque gauge point can be dry under heating/vacuum.After the implantation, the simple molecules of biodegradable bonding agent degradable for being absorbed by health/discharge.Therefore, the radiopaque material is near the dispersion that will become in the at first implanted zone.

Periodically in-site detecting rack mechanical performance is measured the maintenance of recoil strength and the existence of restenosis tissue.Similarly, degraded of support polymer biological and metabolism can be assessed by the quantitative change that the generation and the tissue of measurement echo are formed.The local mechanical performance can be learned (palpography) (6 months by vibrations; 2 years) assess.The decline in time of quality in the polymer degradation processes can be passed through OCT (6 months; 2 years) assessment.The binary restenosis can be used MSCT (18m) quantitative assay.Experimental evidence has shown biodegradable advantage when absorbing support and being used for stay pipe for example.Find, acute send and adaptability aspect, the effect metalloid medicament elution stay pipe (DES) of this support.Yet, found that localized support is absorbed and fully metabolism naturally.Therefore, but the support of bio-absorbable that can be the tubular support form of tubes is not stayed nonvolatil implant and stays natural vascular or the tissue that has healed by fully metabolism.Support of the present invention can be compatible with the CT imaging.

A kind of method that is used to prepare exemplary medical apparatus and instruments comprises: prepare a kind of suitable polymeric compositions that contains or do not contain one or more drug substances; Molding or extrude this polymer composition so that be shaped on the implantation instrument structure.If stay pipe then forms tubular structure and---for example under the help of laser---it is cut the style of being wanted to form subsequently.

In one embodiment, a kind of method of making this medical apparatus and instruments comprises: prepare a kind of biodegradable polymer architecture; Designing described polymer architecture implants in patient's body to be shaped; With laser described structure cuts is become such shaping style, promptly make and to cross apparatus and to be convenient to curling of this apparatus by opening.Preferably, become the structure of sample to contain and above-mentionedly be used for the stable apparatus that curls to make it the being retained in locking tool that carrier/implanted object is fastened safely.

In another embodiment, be used to help to curl and the closed manners of the locking device of the stent configuration of packing into, also can be by biocompatible nonionic or ion-type reagent being joined in support or the groups of holders compound or adding and by chemical modification or enhancing with layer or graft form.That these aniones through modification, cation or nonionic layer can be homogeneous or can be engraved on the interlocking surfaces by utmost point minutia.The dosage level scope that also can be the cationic of surfactant or anionic reagent can be 0.01-10 weight %.The easy dissolving that the external application of described ion-type reagent is preferred for after original position expands is shifted out.The low dosage level of non-ion reagent is suitable for improving friction and interacts, and particularly the friction between the locking mechanism parts interacts.Preferred such nonionic reagent, its by the FDA approval can 0.05-2.5% dosage level use.The support that frictional force improves or be in particular the embodiment on reciprocal interlocking surface provides the nonionic of modified layer to mix.Suitable nonionic reagent can be selected from chemicals, for example ethoxylated fatty amine, fatty acid ester and monoglyceride and diglyceride.

Although the present invention is illustrated especially and describes with reference to specific embodiments, will be appreciated that above disclosed and other feature and the modification of function or their alternative, can be incorporated into multiple other different system or application as required.Multiple equally, the herein present unforeseen or unexpected alternative that can make subsequently by those of ordinary skills, variation, modification or improve and also will be intended to be contained in the claims.

Claims

1. but the flexible support of a bio-absorbable forms a kind of like this pipe with the circumference form around the longitudinal axis, and described pipe has nearly opening and opening far away, and can curl and inflatable, and has the style shape of expanded form, and this support comprises:

By the described near opening spiral extension of described pipe the first multi-part pillar cellular construction to its described opening far away;

By the described near opening spiral extension of described pipe the second multi-part pillar cellular construction to its described opening far away;

Wherein, each parts is by the described near opening spiral extension of described pipe during to its described opening far away, the parts of the described first multi-part pillar cellular construction with respect to the parts of the second multi-part pillar cellular construction into about 120 ° to about 180 °.

2. the support of claim 1, the configuration of each parts pillar cellular construction of the wherein said first multi-part pillar cellular construction is basic identical.

3. the support of claim 1, the configuration of each parts pillar cellular construction of the wherein said second multi-part pillar cellular construction is basic identical.

4. the support of claim 1, the configuration of each parts pillar cellular construction of the wherein said first and second multi-part pillar cellular constructions is basic identical.

5. the support of claim 1, wherein the configuration of each relative parts of the described parts pillar cellular construction between the described first multi-part pillar cellular construction and the second multi-part pillar cellular construction is basic identical.

6. the support of claim 2, wherein each parts forms the H configuration of special format.

7. the support of claim 2, wherein each parts forms the X configuration of special format.

8. the support of claim 2, wherein each parts forms the S configuration of special format.

9. the support of claim 2, wherein each parts forms 8 configurations of special format.

10. the support of claim 2, wherein each parts forms the I configuration of special format.

11. the support of claim 2 also comprises by the described near opening spiral extension of described pipe the 3rd multi-part pillar cellular construction to its described opening far away.

12. the support of claim 11 also comprises by the described near opening spiral extension of described pipe the 4th multi-part pillar cellular construction to its described opening far away.

13. the support of claim 11 also comprises by the described near opening spiral extension of described pipe the 5th multi-part pillar cellular construction to its described opening far away.

14. the support of claim 2, wherein each spiral of two multi-part pillar cellular constructions rotates along the left hand helix direction around described pipe.

15. the support of claim 2, wherein each spiral of two multi-part pillar cellular constructions rotates along the right-handed helix direction around described pipe.

16. the support of claim 2, wherein at least one spiral of two multi-part pillar cellular constructions rotates along the left hand helix direction around described pipe, and another spiral rotates along the right-handed helix direction.

17. the support of claim 11, wherein all spirals of multi-part pillar cellular construction rotate along identical direction around described pipe.

18. but the stay pipe of a bio-absorbable, it comprises the multi-part pillar cellular construction of a plurality of described near opening spiral extensions by described pipe to its described opening far away, wherein, when each parts by the described near opening spiral extension of described pipe during to its described opening far away, the parts of each described multi-part pillar cellular construction with respect to another parts of another multi-part pillar cellular construction into about 120 ° to about 180 °.

19. the support of claim 18, wherein each spiral of multi-part pillar cellular construction rotates along the left hand helix direction around described stay pipe.

20. the support of claim 18, wherein each spiral of two multi-part pillar cellular constructions rotates along the right-handed helix direction around described stay pipe.

21. the support of claim 18, wherein at least one spiral of multi-part pillar cellular construction rotates along the left hand helix direction, and another spiral rotates along the right-handed helix direction around described stay pipe.

22. the support of claim 11, wherein all spirals of multi-part pillar cellular construction rotate along identical direction around described stay pipe.