EP2152332A2 - Dispositif biodégradable pour angioplastie temporaire et induction réparatrice des conduits vasculaires en général et des artères coronaires en particulier - Google Patents
Dispositif biodégradable pour angioplastie temporaire et induction réparatrice des conduits vasculaires en général et des artères coronaires en particulierInfo
- Publication number
- EP2152332A2 EP2152332A2 EP08762782A EP08762782A EP2152332A2 EP 2152332 A2 EP2152332 A2 EP 2152332A2 EP 08762782 A EP08762782 A EP 08762782A EP 08762782 A EP08762782 A EP 08762782A EP 2152332 A2 EP2152332 A2 EP 2152332A2
- Authority
- EP
- European Patent Office
- Prior art keywords
- bio
- tube
- voids
- angioplasty
- tubular
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Withdrawn
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/148—Materials at least partially resorbable by the body
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
Definitions
- Biodegradable device for temporary ankoplasty and restorative induction of vascular ducts in general and coronary arteries in particular
- Coronary artery disease is a functional pathology affecting the coronary arteries following a complex evolution of the endarter leading to its hardening and narrowing. If the causes of the phenomenon are often difficult to specify because they are multiple or combined and may also have their origin in old lesions or alterations, the consequence is always a weakening of the cardiac function by a limited and insufficient oxygen supply by the fact of vascular narrowing inducing an alteration of the blood flow. In developed countries, coronary heart disease affects 1 person
- the available therapeutic approach is based either on the pharmaceutical component for the prevention or the chronic sub-acute treatment or on the interventional part by performing a coronary bypass or an angioplasty.
- Coronary artery bypass surgery is a surgical procedure that involves circumventing the damaged artery area by graft placement from a patient's vascular conduit, by deflecting the upstream flow for reinjection downstream of the damaged length.
- Angioplasty differs from the bypass technique in that it aims to restore the functionality of the damaged artery by reopening the passage constrained by the lesion.
- angioplasty is accompanied by the placement of an implant at the site of the arterial deterioration.
- This implant, or stent according to its generic name, is generally in the form of a small cylindrical metal mesh adapted to keep open the damaged vascular conduit and to allow the continuity of blood flow through the device. Since their first marketing as certified medical devices, the stents have undergone several evolutions without significant modifications of the original principle.
- the present invention relates to a bioabsorbable device for performing in humans the restoration of the circulation in any type of vascular conduit having undergone a damaging transformation of its shape or its initial consistency.
- the device of the invention applies primarily to the refunctionalization of an injured coronary artery.
- This device is in the form of a tubular element made of bioabsorbable material and capable of expansion or constriction to adapt to the diameter of the vascular conduit to be reconciled.
- the functional performance of the device of the invention is improved by the fact that the bioabsorbable material is rendered weakly generating a fibrous reaction and that the tubular form of the element is composed of a succession of solids and voids arranged according to a diagram permitting significant variations in the radial dimension while the length of the tube remains that determined in advance.
- the resorbable material used is known not to generate particles during its resorption and can therefore be placed in a vascular conduit.
- the device of the present invention is further designed to be implanted by a technique and a similar material to those used for the laying of a conventional metal stent.
- the contribution of the device, object of the present invention, in the field of cardiovascular repair surgery is consistent insofar as it eliminates the risk of post-interventional thrombosis without having to require the addition of active pharmaceutical ingredients whose release kinetics is often problematic and can lead to over-dosing accidents.
- the method of setting up the device of the invention is similar to that of the installation of a traditional stent and therefore does not disturb the practitioner.
- the particularly innovative nature of the present invention is the use of a biodegradable material and acting as a promoter of the tissue reconstruction to achieve the entire device.
- This material is resorbed in a controlled way and especially it induces a tissue reconstruction by proposing a favorable support having effects similar to the reconstruction matrices notably those used for the repair of the bone tissues.
- This inducing characteristic of tissue repair can be further enhanced if the outer surface of the device has been specially modified to promote cell reconstruction.
- the present invention relates to a bioabsorbable device for performing in humans the restoration of the circulation in any type of vascular conduit having undergone a damaging transformation of its shape or its initial consistency.
- the device of the invention applies firstly to refoncentralization of an injured coronary artery.
- the object of the present invention is a device, also called coronary tubular bioprosthesis (or bio-tube), studied in its form and made of a biodegradable material suitable for use in the repair surgery of ducts of circulatory systems in humans.
- biotube designate the device object of the present invention, whatever the uses that will be made provided that they remain covered by the field of application given above.
- the bio-tube is in the form of a tube generally of circular section or a hollow cylindro-conical element, for which the thickness of the wall is controlled.
- the bioabsorbable material is arranged in a pattern composed of solids and voids allowing compressions or expansions of the volume. without variation of the thickness of the wall of the device.
- the wall of the bio-tube is constituted by a mesh made of a biodegradable material of the type described in what follows.
- the bio-tube is constituted by a coil spring made of said biodegradable material.
- the bio-tube comprises inside a tubular continuous wall and outside a hollow network of determined shapes, cubic, triangular, etc. practiced in the wall of the biotube.
- this particular structure of the wall of the bio-tube associated with the biodegradable material used makes it possible to obtain a biotube whose wall can be compressed in order to reduce the external diameter for its introduction into the vascular conduit and then allows an expansion, by its own elasticity, of the vascular conduit and a perfect application of the outer wall of the bio-tube against the inner wall of the vascular conduit.
- the main dimensioning parameters of the bio-tube are:
- the bio-tube When the values of Y and y are identical, the bio-tube is called tubular. In this case, the value of the cone angle A is equal to zero. When the values of Y and y are different, the bio-tube is called cylindro-conical. In this case, the value of the cone angle A is non-zero.
- the thickness "e" of the bio-tube material may be unique over the entire length of the device or may take several values varying between the extremes "e m in” and " ⁇ Max " -
- the ends of the bio-tube may be tapered to allow passage of the liquid with a minimum of disturbance. Such a modification is obtained by increasing the value of the inner diameter without varying the value of the external diameter of the device.
- the values assigned to the sizing parameters mentioned above will depend on the application.
- the areas in which the dimensioning magnitudes preferably vary are: - 1.0 ⁇ Y ⁇ 10.0 values expressed in mm
- biodegradable material for producing the bio-tube.
- biodegradable materials have several applications in the field of medical devices, for example as a suture, or as a prosthesis, or as a device for the controlled release of drugs in the body, there is no application in which a biodegradable material is directly and integrally placed in a circulatory duct and has to ensure, in addition to its primary function of repairing element, a function of inducing a curative and evolutionary action coming from the organism itself.
- Biodegradable materials having applications in the health field are obtained from tissues or proteins derived from the animal kingdom, such as collagen or catgut, or from polymers produced by synthesis.
- the chemical natures of the main polymers known to be resorbable include polyesters, polyorthoesters, polyanhydrides, poly (ether) esters, polyamino acids and polydepsipeptides (see for example: B. Buchholz, J. Mater Sci, Mater Med 4 (1993) 381-388).
- the resorbable polymers may be described by a unit corresponding to the general formula:
- X1 denote an oxygen atom or an NH group
- Y1 denotes an oxygen atom, or an NH group, or a chemical bond directly connecting R1 to R3 (respectively R2 to R4), - R1; R2; R3; R4 denote linear or branched carbon chains, saturated or partially unsaturated, bearing or not containing heteroatoms and containing from 0 to 10 carbon atoms.
- Y1 denotes an oxygen atom or a chemical bond directly connecting R1 to R3 (respectively R2 to R4),
- R1; R2; R3; R4 denote linear or branched carbon chains containing from 0 to 5 carbon atoms and preferably from 0 to 3 atoms.
- polymers include, for example, polylactides, polyglycolides, polydioxanones, polyalkylenecarbonates and polylactones. To these homopolymers are added the copolymers obtained by combining the different monomers. These polymers are known for their ability to resorb in vivo according to known and predictable resorption modes. In addition, among these polymers, some will have characteristics of particular interest to enter into the manufacture of the device object of the present invention.
- polydioxanones are known to resorb more slowly than polylactides, or polyglycolides, or even catgut or collagen.
- the flexibility of the obtained material also depends on the nature of the polymer used.
- the mechanical characteristics of the material obtained will vary for example with the chemical nature of the pattern, the molecular weight, the polymerization process, the material processing technique, etc.
- An optional treatment of the device manufactured makes it possible to modify it slightly to reduce the fibrogenic character of the bio-tube.
- This modification can intervene by:
Landscapes
- Health & Medical Sciences (AREA)
- Veterinary Medicine (AREA)
- Vascular Medicine (AREA)
- Engineering & Computer Science (AREA)
- Public Health (AREA)
- Animal Behavior & Ethology (AREA)
- Heart & Thoracic Surgery (AREA)
- Biomedical Technology (AREA)
- Life Sciences & Earth Sciences (AREA)
- General Health & Medical Sciences (AREA)
- Transplantation (AREA)
- Oral & Maxillofacial Surgery (AREA)
- Cardiology (AREA)
- Surgery (AREA)
- Epidemiology (AREA)
- Materials For Medical Uses (AREA)
- Prostheses (AREA)
Abstract
Description
Claims
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
CH9362007 | 2007-06-12 | ||
PCT/IB2008/001441 WO2008152465A2 (fr) | 2007-06-12 | 2008-06-05 | Dispositif biodégradable pour angioplastie temporaire et induction réparatrice des conduits vasculaires en général et des artères coronaires en particulier |
Publications (1)
Publication Number | Publication Date |
---|---|
EP2152332A2 true EP2152332A2 (fr) | 2010-02-17 |
Family
ID=39768493
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
EP08762782A Withdrawn EP2152332A2 (fr) | 2007-06-12 | 2008-06-05 | Dispositif biodégradable pour angioplastie temporaire et induction réparatrice des conduits vasculaires en général et des artères coronaires en particulier |
Country Status (2)
Country | Link |
---|---|
EP (1) | EP2152332A2 (fr) |
WO (1) | WO2008152465A2 (fr) |
Family Cites Families (4)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
JPH0576603A (ja) * | 1991-09-20 | 1993-03-30 | Olympus Optical Co Ltd | 生体管路拡張具 |
EP1284688B1 (fr) * | 2000-05-25 | 2005-10-26 | Bioring SA | Dispositif pour retrecir et/ou renforcer les orifices valvulaires du coeur |
EP1275344A1 (fr) * | 2001-07-09 | 2003-01-15 | Bioring SA | Dispositif pour l'anastomose, la maintenance et la protection vasculaire |
KR20060028695A (ko) * | 2003-06-16 | 2006-03-31 | 난양 테크놀러지컬 유니버시티 | 고분자 스텐트 및 이의 제조 방법 |
-
2008
- 2008-06-05 WO PCT/IB2008/001441 patent/WO2008152465A2/fr active Application Filing
- 2008-06-05 EP EP08762782A patent/EP2152332A2/fr not_active Withdrawn
Non-Patent Citations (1)
Title |
---|
See references of WO2008152465A2 * |
Also Published As
Publication number | Publication date |
---|---|
WO2008152465A2 (fr) | 2008-12-18 |
WO2008152465A3 (fr) | 2009-12-10 |
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Legal Events
Date | Code | Title | Description |
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PUAI | Public reference made under article 153(3) epc to a published international application that has entered the european phase |
Free format text: ORIGINAL CODE: 0009012 |
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17P | Request for examination filed |
Effective date: 20091019 |
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AK | Designated contracting states |
Kind code of ref document: A2 Designated state(s): AT BE BG CH CY CZ DE DK EE ES FI FR GB GR HR HU IE IS IT LI LT LU LV MC MT NL NO PL PT RO SE SI SK TR |
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AX | Request for extension of the european patent |
Extension state: AL BA MK RS |
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RIC1 | Information provided on ipc code assigned before grant |
Ipc: A61L 31/14 20060101ALI20100119BHEP Ipc: A61L 31/06 20060101AFI20100119BHEP |
|
RIN1 | Information on inventor provided before grant (corrected) |
Inventor name: LE GOFF, PHILIPPE Inventor name: DELLA MARTINA, ALBERTO Inventor name: ANDRIEU, RAYMOND |
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17Q | First examination report despatched |
Effective date: 20100316 |
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STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: EXAMINATION IS IN PROGRESS |
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DAX | Request for extension of the european patent (deleted) | ||
STAA | Information on the status of an ep patent application or granted ep patent |
Free format text: STATUS: THE APPLICATION IS DEEMED TO BE WITHDRAWN |
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18D | Application deemed to be withdrawn |
Effective date: 20100928 |