WO2008152465A2 - Biodegradable device for temporary angioplasty and repair of the vessels in general and of the coronary arteries in particular - Google Patents

Biodegradable device for temporary angioplasty and repair of the vessels in general and of the coronary arteries in particular Download PDF

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Publication number
WO2008152465A2
WO2008152465A2 PCT/IB2008/001441 IB2008001441W WO2008152465A2 WO 2008152465 A2 WO2008152465 A2 WO 2008152465A2 IB 2008001441 W IB2008001441 W IB 2008001441W WO 2008152465 A2 WO2008152465 A2 WO 2008152465A2
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WO
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Application
Patent type
Prior art keywords
characterized
device according
device
tube
bio
Prior art date
Application number
PCT/IB2008/001441
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French (fr)
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WO2008152465A3 (en )
Inventor
Raymond Andrieu
Martina Alberto Della
Goff Philippe Le
Original Assignee
Bioring Sa
Priority date (The priority date 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 date listed.)
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Publication date

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61LMETHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION, OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS, OR SURGICAL ARTICLES
    • A61L31/00Materials 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
    • A61L31/14Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
    • A61L31/148Materials at least partially resorbable by the body
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, E.G. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/82Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents

Abstract

The present invention relates to a biodegradable tubular device for angioplasty treatment of vascular sclerosis in general and of coronary disease in particular, without inducing the complications that may possibly be encountered when a permanent device of the stent type is fitted. The property of controlled biodegradability of the device according to the invention, combined with the characteristics of the material used, significantly reduces the post-surgical risks of recurrence of functional complications (restenosis, thrombosis and the like) or of infectious diseases originating near the angioplasty device. The shape and texture of the tubular device permit an adjustment of diameter by virtue of its property of elasticity.

Description

biodegradable device for temporary restorative anqioplastie and induction of vascular conduits in general and in particular coronary artery

STATE OF THE ART:

Coronary heart disease is a functional disease of the coronary arteries in a consecutive manner to a complex evolution of the intima, leading to curing and shrinkage. If the causes of the phenomenon are often difficult to identify because multiple or combined and can also shoot their cause injuries or old alterations, the result is always ultimately a weakening of heart function by a small and insufficient intake of oxygen the fact of the vascular stricture inducing an alteration of the blood flow. In developed countries, coronary heart disease affects 1

20 and represents a major cause of death worldwide.

The therapeutic approach based either available on the pharmaceutical component for the prevention or SCLE chronic treatment either on the interventional component by performing coronary bypass surgery or angioplasty.

Coronary bypass surgery is a surgical procedure of circumventing the blood injured area by placing a graft, taken from a patient's healthy vascular conduit, by bypassing the upstream flow to reinject the downstream of the damaged length. The angioplasty differs from the technique of bridging in that it aims to restore functionality of the artery damaged by reopening the passage forced by injury. In many cases, angioplasty is accompanied by the placement of an implant in the place of blood degradation. This implant or stent along its generic name, is generally in the form of a small cylindrical metal mesh adapted to hold open the damaged vascular conduit and to allow the continuity of blood flow through the device. Since their first marketed as certified medical devices, stents have undergone several changes without significant changes to the original principle.

After a promising start, the use has proved that if the stents are effective in preventing restenosis, they have also shown their limits by being responsible for cases of post-interventional thrombosis.

In response stent manufacturers have proposed devices coated pharmaceutical ingredients responsible for reducing the risk of thrombosis. However, faced with the proliferation of adverse ads up to the patient's death, the FDA warned several manufacturers since 2003 and reported on the risks of the new stents class.

CONTRIBUTION OF INVENTION:

The present invention relates to a bioerodible device for performing in humans the restoration of circulation in any type of vascular conduit having undergone harmful transformation of its shape or from its initial consistency. The device of the invention applies primarily to the restoration to a usable an injured coronary artery. This device is in the form of a tubular element made of the bioabsorbable material and capable of expansion or constriction to accommodate the diameter of the vascular duct to refonctionnaliser.

The functional performance of the device of the invention are improved in that the bioresorbable material is rendered weakly generator and fibrous reaction that the tubular element is composed of a succession of full and empty spaces arranged in a diagram significant variations in the radial dimension while the tube length remains that determined in advance.

Further resorbable material used is known to not 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 by a similar material to those used for the installation of a conventional metal stent.

The contribution of the device, object of the present invention, in the field of restorative cardiovascular surgery is therefore since it removes the risk of post-interventional thrombosis without requiring the addition of pharmaceutical active ingredients whose release kinetics is often problematic and can lead to accidents by over-dosing.

Furthermore the implementation mode of the invention device is similar to installing a traditional stent and therefore does not disturb the practitioner.

The particularly innovative feature of the present invention is the use of a biodegradable material and acting as a promoter for tissue reconstruction to achieve the entire device. This material is absorbed in a controlled manner and above all it induces tissue reconstruction by providing a favorable substrate having similar effects to the reconstruction matrices including those used for repairing bone tissue. This induction character of tissue repair can be further increased if the outside of the device has been specially modified to promote cellular reconstruction.

APPLICATION DOMAIN :

The present invention relates to a bioerodible device for performing in humans the restoration of circulation in any type of vascular conduit having undergone harmful transformation of its shape or from its initial consistency. The device of the invention applies primarily to restoration to a usable an injured coronary artery.

DISCLOSURE OF INVENTION:

The object of the present invention is a device, also called coronary tubular bioprosthesis (or bio-tube), studied in form and made of a suitable biodegradable material for use in reconstructive surgery conduits circulatory systems in humans .

In the following discussion of the description of the invention, the term "BioTube" shall mean the device, object of the present invention, regardless of the uses that will be made provided they are covered by the field of implementation given above.

The bio-tube is in the form of a tube of generally circular cross section or a cylindrical-conical hollowed element, wherein the thickness of the wall is controlled. To allow adaptation of the value of the outer diameter of the bio-tube to the value of the inner diameter of the vascular conduit to refonctionnaliser, the bioresorbable material is arranged in a pattern composed of solids and voids allowing compressions or expansions of the volume without varying the thickness of the wall of the device. In a first variant of the biodegradable device for refonctionalisation a vascular conduit, the wall of the bio-tube consists of a lattice of a biodegradable material of the type described in what follows.

In a second variant of the device the bio-tube is constituted by a helical spring provided in said biodegradable material. In yet another variant of the device, the bio-tube has therein a tubular continuous wall and outside a hollow network determined forms, cubic, triangular etc. in the wall of BioTube.

In all these embodiments of this particular structure of the wall of BioTube associated with the biodegradable material used provides a BioTube whose wall can be compressed to reduce the outer diameter for introduction into the vascular conduit and allows 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:

- D: large inner diameter (in mm unit) - d: small inner diameter (in mm unit)

- L: length (in mm unit)

- e: wall thickness (in mm unit)

By combining these parameters, the values ​​of Y (large outer diameter) and y (small outer diameter) are accessible considering that:

- Y = D + 2

- y = d + 2e

The combination of parameters (d, Y, y) gives access to an additional variable called "cone angle" connector. This quantity is marked with the letter A and in degrees of angles.

A is connected to the triplet (y, Y, L) by the equation:

- A = arctan [(Yy) / L]

When the values ​​of Y and y are identical, the said bio-tube is tubular. In this case, the value of the cone angle A is zero. When the values ​​of Y and y are different, the said bio-tube is cylindro-conical. In this case, the value of the cone angle A is nonzero.

The thickness "e" of bio-material tube may be unique over the entire length of the device or can take several values varying between the extreme "e m in" and "β max" - For example, the ends of the bio-tube may be tapered to allow liquid passage with minimal disruption. Such modification is achieved by increasing the value of the inner diameter without varying the value of the external diameter of the device.

In the main uses of bio-tube, the values ​​assigned to the above mentioned sizing parameters will depend on the application. For all areas in which preferably vary the dimensioning values ​​are: - 1.0 <Y <10.0 values ​​in mm

- y ≤ Y

- (Y - y) <1 0 value expressed in mm

- A <6 ° value expressed in degrees of angle - 5 <(L / Y) <15

- 5 <(y / e M ax) <20

One of the novel features of the invention is to use a biodegradable material for producing bio-tube. Indeed, if the biodegradable materials know several applications in the field of medical devices, such as 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 and has led to ensure, apart from its primary function of repairing element, an induction function of a curative and evolutive from the body itself.

Biodegradable materials with applications in the areas of health are obtained from tissue or proteins from the animal kingdom, such as collagen or catgut, or from polymers produced synthetically.

The chemical nature of the principal polymers known to be resorbable include polyesters, polyorthoesters, polyanhydrides, poly (ether) esters, polyaminoacids and polydepsipeptides (see for example: B. Buchholz; J. Mater Sci Mater Med... . 4 (1993) 381 - 388).

In a more schematic, but not limited to, absorbable polymers can be described by a structure corresponding to the general formula:

- [- X1 -C (O) -RI -Y1 -R2 -] - [- X2-C (O) -R3-Y2-R4 -] -

wherein: - C (O) denotes a group> C = O,

- X1; X2 designate an oxygen atom or an NH group,

- Y1 (respectively Y2) designates an oxygen atom or an NH group, or a chemical bond directly connecting R1 to R3 (respectively R2 to R4), - R1; R2; R3; R4 designate linear or branched carbon chains, saturated or partially unsaturated, bearing or not hetero atoms and containing 0 to 10 carbon atoms.

When in this general formula, X1 is equal to X2 and Y1 is equal to Y2 and R1 is equal to R3 and R2 is equal to R4, the obtained polymer is called homopolymer. Otherwise, the polymer is called copolymer.

Among these polymers, the inventors have paid special attention to the polymers can be described by a structure corresponding to the general formula:

- [- X1 -C (O) -RI -Y1 -R2 -] - [- X2-C (O) -R3-Y2-R4 -] - wherein:

- C (O) denotes a group> C = O, - X1; X2 designate an oxygen atom,

- Y1 (respectively Y2) designates an oxygen atom or a chemical bond directly connecting R1 to R3 (respectively R2 to R4),

- R1; R2; R3; R4 designate linear or branched carbon chains and containing 0 to 5 carbon atoms and preferably 0-3 atoms.

These types of polymers include for example polylactides, polyglycolides, polydioxanones, polyalkylènecarbonates and polylactones. To these homopolymers is compounded by copolymers obtained by combination of different monomers. These polymers are known for their ability to be resorbed in vivo according to known and predictable modes of resorption. Furthermore, among these polymers, some will have particularly interesting characteristics to enter the manufacturing object of the present invention device.

For example, polydioxanones are known to be absorbed more slowly than polylactides or polyglycolides or that catgut or collagen.

On the other hand, the flexibility of the material obtained also depends on the nature of the polymer used. The mechanical characteristics of the obtained material will vary for example with the chemical nature of the pattern, the molecular weight, the polymerization process, the implementation technique of the material ...

The optimization of the different parameters affecting the characteristics of the resulting material, and in particular mode resorption in vivo led to prefer polydioxanones to make the bio-tube. Polydioxanones are polymers obtained from cyclic monomers having the empirical formula C 4 H 6 Os and having a> C = O. They offer a kinetic and way of absorption in vivo compatible with applications of the invention.

An optional treatment device made to change the low to reduce the fibrotic nature of the bio-tube.

This modification can occur by:

- Mechanical treatment of the polymer surface,

- inclusion in the polymer of a material known to reduce inflammation.

Claims

1. A device for the restoration of circulatory function in vascular conduits stenoses, characterized in that it is constituted by a tubular element made of a biodegradable material or bio-tube.
2. Device according to Claim 1, characterized in that it serves to restore the subsequent circulatory function in coronary artery disease by angioplasty.
3. Device according to claim 1 or claim 2, characterized in that it has an inherent elasticity allowing it to be compressed to reduce the outer diameter to its implementation and its expansion to its outer wall is applied against the inner wall of the vascular conduit.
4. Device according to one of the preceding claims, characterized in that the bio-tube has a cylindrical tubular shape.
5. Device according to one of claims 1 to 3, characterized in that the bio-tube has a cylindro-conical tubular shape.
6. Device according to claims 1 to 5, characterized in that it has a succession of full and empty spaces on its outer surface.
7. Device according to claim 6, characterized in that the succession of full and empty spaces are organized so as to enable expansion or constriction of the interior volume of the bio-tube.
8. Device according to Claims 6 and 7, characterized in that the voids are less than 50% of the developed surface.
9. Device according to one of claims 6 to 8, characterized in that the voids are arranged in a discontinuous organization of mesh type.
10. Device according to one of claims 6 to 8, characterized in that the voids are arranged in a continuous spring-like organization.
11. Device according to one of claims 6 to 10, characterized in that its dimensions, length and inner and outer diameters are adapted to the repair of the coronary arteries.
12. Device according to one of claims 6 to 11, characterized in that its length is preferably between 5 mm and 30 mm.
13. Device according to one of claims 6 to 12, characterized in that its outer diameter is preferably between 1 mm and 10 mm.
14. Device according to one of the preceding claims, characterized in that the thickness of the material constituting the tubular casing is constant over the entire length of the device.
15. Device according to one of the preceding claims, characterized in that a mechanical treatment of the surface reduces the fibrous reaction.
16. Device according to one of the preceding claims, characterized in that a chemical surface treatment is performed to reduce the fibrotic reaction.
17. Device according to one of the preceding claims, characterized in that the device is made of a polymer can be described by the general pattern - [- XC (O) -RI -Y-R2 -] - in which C ( O) denotes a group> C = O; X denotes an oxygen atom; Y denotes an oxygen atom or a chemical bond linking R1 to R2; R1 and R2 denote linear or branched carbon chains and containing 0 to 5 carbon atoms and preferably 0-3 atoms.
18. Device according to claim 17, characterized in that the polymer used is polylactide or polyglycolide or polylactone or polyalkylènecarbonate, or, preferably, polydioxanone type or any other type of polymer as long as it latter is obtained from a cyclic compound having the empirical formula C 4 H 6 O 3 and having a> C = O.
19. Device according to one of claims 1 to 15, characterized in that the polymer used to constitute the device is a copolymer obtained by combination of different monomers leading to the polymers claimed in claims 16-18.
20. Device according to one of the preceding claims, characterized in that a biocompatible material known for its anti-inflammatory effect is incorporated into the biodegradable material at maximum 5% weight competition.
PCT/IB2008/001441 2007-06-12 2008-06-05 Biodegradable device for temporary angioplasty and repair of the vessels in general and of the coronary arteries in particular WO2008152465A3 (en)

Priority Applications (2)

Application Number Priority Date Filing Date Title
CH00936/07 2007-06-12
CH9362007 2007-06-12

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
EP20080762782 EP2152332A2 (en) 2007-06-12 2008-06-05 Biodegradable device for temporary angioplasty and repair of the vessels in general and of the coronary arteries in particular

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WO2008152465A2 true true WO2008152465A2 (en) 2008-12-18
WO2008152465A3 true WO2008152465A3 (en) 2009-12-10

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Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001089426A1 (en) * 2000-05-25 2001-11-29 Bioring S.A. Device for shrinking or reinforcing the heart valvular orifices
WO2003005910A1 (en) * 2001-07-09 2003-01-23 Bioring Sa Device for vascular anastomosis, retention and protection
WO2004110315A1 (en) * 2003-06-16 2004-12-23 Nanyang Technological University Polymeric stent and method of manufacture

Family Cites Families (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
JPH0576603A (en) * 1991-09-20 1993-03-30 Olympus Optical Co Ltd Organic duct expander

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
WO2001089426A1 (en) * 2000-05-25 2001-11-29 Bioring S.A. Device for shrinking or reinforcing the heart valvular orifices
WO2003005910A1 (en) * 2001-07-09 2003-01-23 Bioring Sa Device for vascular anastomosis, retention and protection
WO2004110315A1 (en) * 2003-06-16 2004-12-23 Nanyang Technological University Polymeric stent and method of manufacture

Non-Patent Citations (3)

* Cited by examiner, † Cited by third party
Title
AGRAWAL C M ET AL: "Evaluation of poly(L-lactic acid) as a material for intravascular polymeric stents" BIOMATERIALS, ELSEVIER SCIENCE PUBLISHERS BV., BARKING, GB, vol. 13, no. 3, 1 janvier 1992 (1992-01-01), pages 176-182, XP024142158 ISSN: 0142-9612 [extrait le 1992-01-01] *
DATABASE WPI Week 199317 Thomson Scientific, London, GB; AN 1993-139633 XP002550047 & JP 05 076603 A (OLYMPUS OPTICAL CO LTD) 30 mars 1993 (1993-03-30) *
TAMAI H ET AL: "Initial and 6-month Results of Biodegradable Poly-l-Lactic acid Coronary Stents in Humans" CIRCULATION, vol. 102, 2000, pages 399-409, XP002550046 *

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Publication number Publication date Type
EP2152332A2 (en) 2010-02-17 application
WO2008152465A3 (en) 2009-12-10 application

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