CA2497602C - Stent with rough surface and its manufacture - Google Patents
Stent with rough surface and its manufacture Download PDFInfo
- Publication number
- CA2497602C CA2497602C CA2497602A CA2497602A CA2497602C CA 2497602 C CA2497602 C CA 2497602C CA 2497602 A CA2497602 A CA 2497602A CA 2497602 A CA2497602 A CA 2497602A CA 2497602 C CA2497602 C CA 2497602C
- Authority
- CA
- Canada
- Prior art keywords
- stent
- roughened
- drug
- stmt
- imperfections
- 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.)
- Expired - Lifetime
Links
- 238000004519 manufacturing process Methods 0.000 title description 3
- 239000003814 drug Substances 0.000 claims abstract description 21
- 229940079593 drug Drugs 0.000 claims abstract description 15
- 238000000034 method Methods 0.000 claims description 11
- 238000005488 sandblasting Methods 0.000 claims description 8
- QJJXYPPXXYFBGM-LFZNUXCKSA-N Tacrolimus Chemical compound C1C[C@@H](O)[C@H](OC)C[C@@H]1\C=C(/C)[C@@H]1[C@H](C)[C@@H](O)CC(=O)[C@H](CC=C)/C=C(C)/C[C@H](C)C[C@H](OC)[C@H]([C@H](C[C@H]2C)OC)O[C@@]2(O)C(=O)C(=O)N2CCCC[C@H]2C(=O)O1 QJJXYPPXXYFBGM-LFZNUXCKSA-N 0.000 claims description 5
- 229960001967 tacrolimus Drugs 0.000 claims description 5
- QJJXYPPXXYFBGM-SHYZHZOCSA-N tacrolimus Natural products CO[C@H]1C[C@H](CC[C@@H]1O)C=C(C)[C@H]2OC(=O)[C@H]3CCCCN3C(=O)C(=O)[C@@]4(O)O[C@@H]([C@H](C[C@H]4C)OC)[C@@H](C[C@H](C)CC(=C[C@@H](CC=C)C(=O)C[C@H](O)[C@H]2C)C)OC QJJXYPPXXYFBGM-SHYZHZOCSA-N 0.000 claims description 5
- 239000011248 coating agent Substances 0.000 claims description 4
- 238000000576 coating method Methods 0.000 claims description 4
- 238000005422 blasting Methods 0.000 claims description 3
- 238000005507 spraying Methods 0.000 claims description 2
- 238000007788 roughening Methods 0.000 claims 1
- 229910001220 stainless steel Inorganic materials 0.000 claims 1
- 239000010935 stainless steel Substances 0.000 claims 1
- 208000007536 Thrombosis Diseases 0.000 abstract description 6
- 230000015572 biosynthetic process Effects 0.000 abstract description 6
- 229940124597 therapeutic agent Drugs 0.000 abstract description 5
- 208000031481 Pathologic Constriction Diseases 0.000 abstract description 3
- 208000037804 stenosis Diseases 0.000 abstract description 3
- 230000036262 stenosis Effects 0.000 abstract description 3
- 230000008901 benefit Effects 0.000 description 4
- 208000037803 restenosis Diseases 0.000 description 4
- 210000004027 cell Anatomy 0.000 description 2
- 229910052593 corundum Inorganic materials 0.000 description 2
- 239000010431 corundum Substances 0.000 description 2
- 210000002889 endothelial cell Anatomy 0.000 description 2
- 230000006872 improvement Effects 0.000 description 2
- 230000014759 maintenance of location Effects 0.000 description 2
- 229910052751 metal Inorganic materials 0.000 description 2
- 239000002184 metal Substances 0.000 description 2
- 229920000642 polymer Polymers 0.000 description 2
- 239000000126 substance Substances 0.000 description 2
- QDZRBIRIPNZRSG-UHFFFAOYSA-N titanium nitrate Chemical compound [O-][N+](=O)O[Ti](O[N+]([O-])=O)(O[N+]([O-])=O)O[N+]([O-])=O QDZRBIRIPNZRSG-UHFFFAOYSA-N 0.000 description 2
- 241000110717 Sclerolaena bicornis Species 0.000 description 1
- YJZATOSJMRIRIW-UHFFFAOYSA-N [Ir]=O Chemical compound [Ir]=O YJZATOSJMRIRIW-UHFFFAOYSA-N 0.000 description 1
- 239000000919 ceramic Substances 0.000 description 1
- 238000006243 chemical reaction Methods 0.000 description 1
- 238000010586 diagram Methods 0.000 description 1
- 230000003511 endothelial effect Effects 0.000 description 1
- 210000001035 gastrointestinal tract Anatomy 0.000 description 1
- 238000010348 incorporation Methods 0.000 description 1
- 208000014674 injury Diseases 0.000 description 1
- 239000000463 material Substances 0.000 description 1
- 239000002245 particle Substances 0.000 description 1
- 238000005498 polishing Methods 0.000 description 1
- 230000008569 process Effects 0.000 description 1
- 230000001737 promoting effect Effects 0.000 description 1
- 230000009467 reduction Effects 0.000 description 1
- 239000004576 sand Substances 0.000 description 1
- 229940126585 therapeutic drug Drugs 0.000 description 1
- 230000007704 transition Effects 0.000 description 1
- 230000008733 trauma Effects 0.000 description 1
- 210000001635 urinary tract Anatomy 0.000 description 1
- 230000002792 vascular Effects 0.000 description 1
- 210000005166 vasculature Anatomy 0.000 description 1
Classifications
-
- 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
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
-
- 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
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
- A61F2/915—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes with bands having a meander structure, adjacent bands being connected to each other
-
- 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
-
- 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
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B24—GRINDING; POLISHING
- B24C—ABRASIVE OR RELATED BLASTING WITH PARTICULATE MATERIAL
- B24C1/00—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods
- B24C1/06—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods for producing matt surfaces, e.g. on plastic materials, on glass
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B24—GRINDING; POLISHING
- B24C—ABRASIVE OR RELATED BLASTING WITH PARTICULATE MATERIAL
- B24C1/00—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods
- B24C1/08—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods for polishing surfaces, e.g. smoothing a surface by making use of liquid-borne abrasives
- B24C1/083—Deburring
-
- B—PERFORMING OPERATIONS; TRANSPORTING
- B24—GRINDING; POLISHING
- B24C—ABRASIVE OR RELATED BLASTING WITH PARTICULATE MATERIAL
- B24C1/00—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods
- B24C1/10—Methods for use of abrasive blasting for producing particular effects; Use of auxiliary equipment in connection with such methods for compacting surfaces, e.g. shot-peening
-
- 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
- A61F2210/00—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2210/0076—Particular material properties of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof multilayered, e.g. laminated structures
-
- 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
- A61L2400/00—Materials characterised by their function or physical properties
- A61L2400/18—Modification of implant surfaces in order to improve biocompatibility, cell growth, fixation of biomolecules, e.g. plasma treatment
Abstract
A stent is provided wherein at least an outer surface portion is roughened to a predetermined extent and wherein a drug or a therapeutic agent can be applied to said surface. This results in an improved stent, which can be manufactured at low costs and which can further avoid thrombus formation and a stenosis.
Description
Stent with rough surface and its manufacture The present invention relates generally to stems which are implantable or deployable in a vascular or endoluminal location within the body of a patient to maintain the lumen open and unoccluded at that location, and in particular to improvements in stems.
First of all, stents are widely used for numerous applications where the stmt is placed in the lumen of a patient and expanded. Said stems may be used in coronary or other vasculature as well as within the urinary tract, the bial tract and the intestinal tract among other body passageways and conduits.
Commonly, stents are cylindrical members which are expanded from reduced diameters to enlarged diameters. Frequently, such stems are placed on a balloon catheter with the stmt in a reduced diameter state. To prevent that the balloon is damaged because of sharp corners and burrs on the surface of the stem and further to avoid thrombus formation, stems are highly polished. This is done for example by sandblasting the surface to remove said imperfections and polishing the stmt afterwards to get a smooth surface.
Unfortunately, the balloon catheder mounted stmt can be dislodged from the uninflated balloon as a result of the navigation through the vessel of the body to the preselected site for deployment because of the highly polished surface. Furthermore, the polished and smooth surface used to avoid thrombus formation has the disadvantage, that endothelial cells have difficulties to ingrow the stmt which can result in that restenosis occurs.
In the prior art, some stems are sandblasted on their interior surface to improve stmt retention on the balloon.
In US-A-6 254 631 B 1 a stmt is disclosed, wherein the exterior surface of the stmt is polished such that a smooth surface finish is achieved. The interior surface having a rough surface finish is rougher than the surface finish of the exterior surface to enhance the friction between the stmt and the balloon.
Further in US-A-6 217 607 B 1 a stmt is disclosed which is provided with a first layer of nobel metal. Further a second outermost layer is provided which is composed of a ceramic like metal such as iridium oxid or titanium nitrate. The second layer is formed with a rough surface to provide an increased friction factor and retention on a balloon during advancement of the stmt delivery system through the vessel.
In WO 99/07308 a stmt is disclosed wherein a portion of a stmt supporting structure is encapsulated with a thin flexible coating made of a polymer which can be used as a carrier for supporting therapeutic agents and drugs. Furthermore, the supporting structure, preferably only the portion which is not encapsulated by the thin flexible coating, is further processed to form a porous exterior surface. Said porous exterior surface renders the exposed portions of the supporting structure, such as the proximal and distal ends more biocompatible by promoting tissue in-growth while reducing the formation of blood clots.
Said stents of the prior art have the disadvantage that they are complicated to manufacture and expensive.
The object of the present invention is therefore to provide an improved stmt, which can be manufactured at low costs and which can further avoid thrombus formation and a stenosis.
This object is achieved by the features of the claims.
According to the invention a stmt is provided comprising at least an outer surface portion which is roughened to a predetermined extent and wherein a drug or a therapeutic agent can be applied to said surface.
This has the advantage, that the stmt does not have to be provided with an additional drug deposit e.g. a polymer layer suitable to carry a drug or therapeutic agent.
Instead the drug can be applied directly to the rough surface and released over a predetermined time after the stent has been placed in a desired location of a lumen. Furthermore a roughened exterior J
surface decrease in-stmt restenosis, since cells can attach more easily to said surface than to a smooth one which results in that endothelial ingrowth is accelerated. Intima cells can grow on the rough surface and attach themselves, wherein the endothelialization of the vessel or lumen is promoted. The endothelial cell layer is very smooth and therefore thrombus formation and a stenosis can be avoided.
In a prefen-ed embodiment the drug e.g. Tacrolimus is applied to the rough surface by spraying. This has the advantage, that the application of the drug is effective, simple and inexpensive.
In .a further preferred embodiment of the invention imperfections such as e.g.
burrs are removed before at least a portion of the surface of the stmt is roughened.
This has the advantage that the surface can be roughened more uniform which leads to better flow dynamics. Thus less turbulences can occur on the surface which results in a reduction of restenosis.
In a preferred embodiment of the invention the surface is roughened to a predetermined extent by sandblasting. Moreover, sandblasting results in an improvement of the fatigue behaviour. Further the durability of the stmt and the surface bonding can be improved. The rough surface also provides an increased surface area for an attachment of a drug or therapeutic agent. Further a stent with a thinner wall with higher radial force and therefore less material can be achieved which also leads to a decrease of restenosis.
With sandblasting the surface can be better controlled and produced and further a more uniform and trauma less surface can be achieved.
Furthermore, the use of corundum for sandblasting results in a surface which is technically different from a normal sandblasted surface. It has the advantage that less energy has to be used and/or less time for this finishing sandblasting than for a sandblasting process to remove burrs. Further the sandblasted surface has less depth with regard to the "cavities".
Furthermore the chemical behaviour of such a stmt is different from commonly known electropolished stents. The surface chemistry is different due to the incorporation of sand particles into the surface. An immediately repassivated surface leads to more chemically stable passive layers than surfaces which have been passivated in equilibrium.
When blasting the surface the resulting lattice imperfections (e.g. vacancy, dislocation) and further possible phase transitions lead to an increased surface energy and thus to a surface which is chemically more reactive. This can lead to a faster chemical running and/or to additional chemical reactions than in the equilibrium.
In a further preferred embodiment the scent is annealed after the surface has been roughened to a predetermined extent to make. him more flexible.
The invention will now be described with reference to the figures, in which figures 1 to 7 show sandblasted exterior and side surfaces of a stent in different resolutions, figures 8 to 14 show sandblasted interior and side surfaces of a stmt in different resolutions, figure 15 shows a table 1, including a list of samples of stents which are used for studying content and release of a drug applied on their surface, figure 16 show tables 2 and 3 wherein the results of several samples regarding their content are listed, figure 17 show tables 4 and 5, wherein samples are studied regarding release of the drug Tacrolimus, and figure 18 shows a diagram, wherein the release of Tacrolimus of samples with respect to time is shown.
In an embodiment of a stmt according to the invention, as shown in figures 1 to 14, the complete surface, i.e. exterior surface, interior surface and side surfaces, is sandblasted by using corundum. It is obvious that the invention is not limited to said embodiment and that also only portions of the surface can be roughened.
In figures 15 to 18 content and release of samples of stems are studied. In this connection normal manufactured stents are compared with stems which are further processed according S
to the invention. Based on the examples shown in the figures the improved properties of stems according to the invention can be demonstrated.
First of all, stents are widely used for numerous applications where the stmt is placed in the lumen of a patient and expanded. Said stems may be used in coronary or other vasculature as well as within the urinary tract, the bial tract and the intestinal tract among other body passageways and conduits.
Commonly, stents are cylindrical members which are expanded from reduced diameters to enlarged diameters. Frequently, such stems are placed on a balloon catheter with the stmt in a reduced diameter state. To prevent that the balloon is damaged because of sharp corners and burrs on the surface of the stem and further to avoid thrombus formation, stems are highly polished. This is done for example by sandblasting the surface to remove said imperfections and polishing the stmt afterwards to get a smooth surface.
Unfortunately, the balloon catheder mounted stmt can be dislodged from the uninflated balloon as a result of the navigation through the vessel of the body to the preselected site for deployment because of the highly polished surface. Furthermore, the polished and smooth surface used to avoid thrombus formation has the disadvantage, that endothelial cells have difficulties to ingrow the stmt which can result in that restenosis occurs.
In the prior art, some stems are sandblasted on their interior surface to improve stmt retention on the balloon.
In US-A-6 254 631 B 1 a stmt is disclosed, wherein the exterior surface of the stmt is polished such that a smooth surface finish is achieved. The interior surface having a rough surface finish is rougher than the surface finish of the exterior surface to enhance the friction between the stmt and the balloon.
Further in US-A-6 217 607 B 1 a stmt is disclosed which is provided with a first layer of nobel metal. Further a second outermost layer is provided which is composed of a ceramic like metal such as iridium oxid or titanium nitrate. The second layer is formed with a rough surface to provide an increased friction factor and retention on a balloon during advancement of the stmt delivery system through the vessel.
In WO 99/07308 a stmt is disclosed wherein a portion of a stmt supporting structure is encapsulated with a thin flexible coating made of a polymer which can be used as a carrier for supporting therapeutic agents and drugs. Furthermore, the supporting structure, preferably only the portion which is not encapsulated by the thin flexible coating, is further processed to form a porous exterior surface. Said porous exterior surface renders the exposed portions of the supporting structure, such as the proximal and distal ends more biocompatible by promoting tissue in-growth while reducing the formation of blood clots.
Said stents of the prior art have the disadvantage that they are complicated to manufacture and expensive.
The object of the present invention is therefore to provide an improved stmt, which can be manufactured at low costs and which can further avoid thrombus formation and a stenosis.
This object is achieved by the features of the claims.
According to the invention a stmt is provided comprising at least an outer surface portion which is roughened to a predetermined extent and wherein a drug or a therapeutic agent can be applied to said surface.
This has the advantage, that the stmt does not have to be provided with an additional drug deposit e.g. a polymer layer suitable to carry a drug or therapeutic agent.
Instead the drug can be applied directly to the rough surface and released over a predetermined time after the stent has been placed in a desired location of a lumen. Furthermore a roughened exterior J
surface decrease in-stmt restenosis, since cells can attach more easily to said surface than to a smooth one which results in that endothelial ingrowth is accelerated. Intima cells can grow on the rough surface and attach themselves, wherein the endothelialization of the vessel or lumen is promoted. The endothelial cell layer is very smooth and therefore thrombus formation and a stenosis can be avoided.
In a prefen-ed embodiment the drug e.g. Tacrolimus is applied to the rough surface by spraying. This has the advantage, that the application of the drug is effective, simple and inexpensive.
In .a further preferred embodiment of the invention imperfections such as e.g.
burrs are removed before at least a portion of the surface of the stmt is roughened.
This has the advantage that the surface can be roughened more uniform which leads to better flow dynamics. Thus less turbulences can occur on the surface which results in a reduction of restenosis.
In a preferred embodiment of the invention the surface is roughened to a predetermined extent by sandblasting. Moreover, sandblasting results in an improvement of the fatigue behaviour. Further the durability of the stmt and the surface bonding can be improved. The rough surface also provides an increased surface area for an attachment of a drug or therapeutic agent. Further a stent with a thinner wall with higher radial force and therefore less material can be achieved which also leads to a decrease of restenosis.
With sandblasting the surface can be better controlled and produced and further a more uniform and trauma less surface can be achieved.
Furthermore, the use of corundum for sandblasting results in a surface which is technically different from a normal sandblasted surface. It has the advantage that less energy has to be used and/or less time for this finishing sandblasting than for a sandblasting process to remove burrs. Further the sandblasted surface has less depth with regard to the "cavities".
Furthermore the chemical behaviour of such a stmt is different from commonly known electropolished stents. The surface chemistry is different due to the incorporation of sand particles into the surface. An immediately repassivated surface leads to more chemically stable passive layers than surfaces which have been passivated in equilibrium.
When blasting the surface the resulting lattice imperfections (e.g. vacancy, dislocation) and further possible phase transitions lead to an increased surface energy and thus to a surface which is chemically more reactive. This can lead to a faster chemical running and/or to additional chemical reactions than in the equilibrium.
In a further preferred embodiment the scent is annealed after the surface has been roughened to a predetermined extent to make. him more flexible.
The invention will now be described with reference to the figures, in which figures 1 to 7 show sandblasted exterior and side surfaces of a stent in different resolutions, figures 8 to 14 show sandblasted interior and side surfaces of a stmt in different resolutions, figure 15 shows a table 1, including a list of samples of stents which are used for studying content and release of a drug applied on their surface, figure 16 show tables 2 and 3 wherein the results of several samples regarding their content are listed, figure 17 show tables 4 and 5, wherein samples are studied regarding release of the drug Tacrolimus, and figure 18 shows a diagram, wherein the release of Tacrolimus of samples with respect to time is shown.
In an embodiment of a stmt according to the invention, as shown in figures 1 to 14, the complete surface, i.e. exterior surface, interior surface and side surfaces, is sandblasted by using corundum. It is obvious that the invention is not limited to said embodiment and that also only portions of the surface can be roughened.
In figures 15 to 18 content and release of samples of stems are studied. In this connection normal manufactured stents are compared with stems which are further processed according S
to the invention. Based on the examples shown in the figures the improved properties of stems according to the invention can be demonstrated.
Claims (14)
1. A stent for placement in a body lumen, said stent being expandable from a contracted state to an expanded state and comprising:
a) an exterior surface, an interior surface and side surfaces, b) wherein at least a portion of the exterior surface and the interior surface is roughened for direct coating with a drug, wherein the surfaces are roughened by corundum-blasting.
a) an exterior surface, an interior surface and side surfaces, b) wherein at least a portion of the exterior surface and the interior surface is roughened for direct coating with a drug, wherein the surfaces are roughened by corundum-blasting.
2. The stent according to claim 1, wherein at least a portion of the side surfaces is roughened.
3. The stent according to claim 1, wherein the drug is Tacrolimus.
4. The stent according to any one of claims 1 to 3, wherein said stent comprises a stainless steel.
5. A balloon catheter device for inserting a tubular stent, comprising a stent as defined in any one of claims 1 to 4.
6. A method for fabricating a stent for placement in a body lumen, said method comprising the following steps:
a) forming a stent which can be employed from a contracted state to an expanded state, said stent having an exterior surface, an interior surface and side surfaces;
b) roughening of at least a portion of the exterior surface and the interior surface to a predetermined extent, wherein the surfaces are roughened by corundum-blasting;
and c) coating of said surface directly with a drug.
a) forming a stent which can be employed from a contracted state to an expanded state, said stent having an exterior surface, an interior surface and side surfaces;
b) roughening of at least a portion of the exterior surface and the interior surface to a predetermined extent, wherein the surfaces are roughened by corundum-blasting;
and c) coating of said surface directly with a drug.
7. The method according to claim 6, wherein at least a portion of the side surfaces is roughened to a predetermined extent.
8. The method according to claim 6 or claim 7, including an additional step d) after step a) wherein imperfections such as sharp edges and burrs are removed from the surface of the stent.
9. The method according to claim 8, wherein the imperfections are removed by burring.
10. The method according to claim 8 or claim 9, wherein the imperfections are removed by electropolishing.
11. The method according to any one of claims 8 to 10, wherein the imperfections are removed by sandblasting.
12. The method according to any one of claims 6 to 11, wherein the drug is Tacrolimus.
13. The method according to any one of claims 6 to 12, wherein the drug is applied by spraying on the roughened surfaces.
14. The method according to any one of claims 6 to 13, wherein the stent is annealed.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP02021067A EP1402849B2 (en) | 2002-09-20 | 2002-09-20 | Stent with rough surface and its manufacturing method |
EP02021067.0 | 2002-09-20 | ||
PCT/EP2003/010542 WO2004026177A1 (en) | 2002-09-20 | 2003-09-22 | Stent with rough surface and its manufacture |
Publications (2)
Publication Number | Publication Date |
---|---|
CA2497602A1 CA2497602A1 (en) | 2004-04-01 |
CA2497602C true CA2497602C (en) | 2012-11-20 |
Family
ID=31970283
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA2497602A Expired - Lifetime CA2497602C (en) | 2002-09-20 | 2003-09-22 | Stent with rough surface and its manufacture |
Country Status (8)
Country | Link |
---|---|
US (2) | US20060155361A1 (en) |
EP (1) | EP1402849B2 (en) |
JP (1) | JP2005538790A (en) |
AT (1) | ATE392864T1 (en) |
AU (1) | AU2003271633A1 (en) |
CA (1) | CA2497602C (en) |
DE (1) | DE60226236T3 (en) |
WO (1) | WO2004026177A1 (en) |
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8353949B2 (en) | 2006-09-14 | 2013-01-15 | Boston Scientific Scimed, Inc. | Medical devices with drug-eluting coating |
US8431149B2 (en) | 2007-03-01 | 2013-04-30 | Boston Scientific Scimed, Inc. | Coated medical devices for abluminal drug delivery |
US8449603B2 (en) | 2008-06-18 | 2013-05-28 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
US8574615B2 (en) | 2006-03-24 | 2013-11-05 | Boston Scientific Scimed, Inc. | Medical devices having nanoporous coatings for controlled therapeutic agent delivery |
US8771343B2 (en) | 2006-06-29 | 2014-07-08 | Boston Scientific Scimed, Inc. | Medical devices with selective titanium oxide coatings |
US8815273B2 (en) | 2007-07-27 | 2014-08-26 | Boston Scientific Scimed, Inc. | Drug eluting medical devices having porous layers |
US8815275B2 (en) | 2006-06-28 | 2014-08-26 | Boston Scientific Scimed, Inc. | Coatings for medical devices comprising a therapeutic agent and a metallic material |
US8900292B2 (en) | 2007-08-03 | 2014-12-02 | Boston Scientific Scimed, Inc. | Coating for medical device having increased surface area |
US8920491B2 (en) | 2008-04-22 | 2014-12-30 | Boston Scientific Scimed, Inc. | Medical devices having a coating of inorganic material |
US8932346B2 (en) | 2008-04-24 | 2015-01-13 | Boston Scientific Scimed, Inc. | Medical devices having inorganic particle layers |
US9284409B2 (en) | 2007-07-19 | 2016-03-15 | Boston Scientific Scimed, Inc. | Endoprosthesis having a non-fouling surface |
Families Citing this family (46)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7713297B2 (en) | 1998-04-11 | 2010-05-11 | Boston Scientific Scimed, Inc. | Drug-releasing stent with ceramic-containing layer |
US7727221B2 (en) | 2001-06-27 | 2010-06-01 | Cardiac Pacemakers Inc. | Method and device for electrochemical formation of therapeutic species in vivo |
US7901451B2 (en) | 2004-09-24 | 2011-03-08 | Biosensors International Group, Ltd. | Drug-delivery endovascular stent and method for treating restenosis |
US8840660B2 (en) | 2006-01-05 | 2014-09-23 | Boston Scientific Scimed, Inc. | Bioerodible endoprostheses and methods of making the same |
US8089029B2 (en) | 2006-02-01 | 2012-01-03 | Boston Scientific Scimed, Inc. | Bioabsorbable metal medical device and method of manufacture |
US8187620B2 (en) | 2006-03-27 | 2012-05-29 | Boston Scientific Scimed, Inc. | Medical devices comprising a porous metal oxide or metal material and a polymer coating for delivering therapeutic agents |
US8048150B2 (en) | 2006-04-12 | 2011-11-01 | Boston Scientific Scimed, Inc. | Endoprosthesis having a fiber meshwork disposed thereon |
JP2009545407A (en) | 2006-08-02 | 2009-12-24 | ボストン サイエンティフィック サイムド,インコーポレイテッド | End prosthesis with 3D decomposition control |
DE602007011114D1 (en) | 2006-09-15 | 2011-01-20 | Boston Scient Scimed Inc | BIODEGRADABLE ENDOPROTHESIS WITH BIOSTABILES INORGANIC LAYERS |
WO2008034066A1 (en) | 2006-09-15 | 2008-03-20 | Boston Scientific Limited | Bioerodible endoprostheses and methods of making the same |
WO2008034013A2 (en) | 2006-09-15 | 2008-03-20 | Boston Scientific Limited | Medical devices and methods of making the same |
JP2010503489A (en) | 2006-09-15 | 2010-02-04 | ボストン サイエンティフィック リミテッド | Biodegradable endoprosthesis and method for producing the same |
WO2008036548A2 (en) | 2006-09-18 | 2008-03-27 | Boston Scientific Limited | Endoprostheses |
US20080097591A1 (en) | 2006-10-20 | 2008-04-24 | Biosensors International Group | Drug-delivery endovascular stent and method of use |
US8067055B2 (en) * | 2006-10-20 | 2011-11-29 | Biosensors International Group, Ltd. | Drug-delivery endovascular stent and method of use |
US20080103584A1 (en) * | 2006-10-25 | 2008-05-01 | Biosensors International Group | Temporal Intraluminal Stent, Methods of Making and Using |
US7981150B2 (en) | 2006-11-09 | 2011-07-19 | Boston Scientific Scimed, Inc. | Endoprosthesis with coatings |
ES2506144T3 (en) | 2006-12-28 | 2014-10-13 | Boston Scientific Limited | Bioerodible endoprosthesis and their manufacturing procedure |
US8070797B2 (en) | 2007-03-01 | 2011-12-06 | Boston Scientific Scimed, Inc. | Medical device with a porous surface for delivery of a therapeutic agent |
US8067054B2 (en) | 2007-04-05 | 2011-11-29 | Boston Scientific Scimed, Inc. | Stents with ceramic drug reservoir layer and methods of making and using the same |
US7976915B2 (en) | 2007-05-23 | 2011-07-12 | Boston Scientific Scimed, Inc. | Endoprosthesis with select ceramic morphology |
US7942926B2 (en) | 2007-07-11 | 2011-05-17 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
US8002823B2 (en) | 2007-07-11 | 2011-08-23 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
US7931683B2 (en) | 2007-07-27 | 2011-04-26 | Boston Scientific Scimed, Inc. | Articles having ceramic coated surfaces |
WO2009018340A2 (en) | 2007-07-31 | 2009-02-05 | Boston Scientific Scimed, Inc. | Medical device coating by laser cladding |
US8052745B2 (en) | 2007-09-13 | 2011-11-08 | Boston Scientific Scimed, Inc. | Endoprosthesis |
KR100930167B1 (en) * | 2007-09-19 | 2009-12-07 | 삼성전기주식회사 | Ultra wide angle optical system |
US8216632B2 (en) | 2007-11-02 | 2012-07-10 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
US7938855B2 (en) | 2007-11-02 | 2011-05-10 | Boston Scientific Scimed, Inc. | Deformable underlayer for stent |
US8029554B2 (en) | 2007-11-02 | 2011-10-04 | Boston Scientific Scimed, Inc. | Stent with embedded material |
LT2252340T (en) * | 2007-11-06 | 2016-11-25 | Alexander Rübben | Method for producing a bioactive surface on an endoprosthesis or on the balloon of a balloon catheter |
US7833266B2 (en) | 2007-11-28 | 2010-11-16 | Boston Scientific Scimed, Inc. | Bifurcated stent with drug wells for specific ostial, carina, and side branch treatment |
EP2265299B1 (en) | 2008-04-08 | 2013-03-13 | Cook Medical Technologies LLC | Surface structure of a component of a medical device and a method of forming the surface structure |
US7998192B2 (en) | 2008-05-09 | 2011-08-16 | Boston Scientific Scimed, Inc. | Endoprostheses |
US8236046B2 (en) | 2008-06-10 | 2012-08-07 | Boston Scientific Scimed, Inc. | Bioerodible endoprosthesis |
US7951193B2 (en) | 2008-07-23 | 2011-05-31 | Boston Scientific Scimed, Inc. | Drug-eluting stent |
US7985252B2 (en) | 2008-07-30 | 2011-07-26 | Boston Scientific Scimed, Inc. | Bioerodible endoprosthesis |
US8382824B2 (en) | 2008-10-03 | 2013-02-26 | Boston Scientific Scimed, Inc. | Medical implant having NANO-crystal grains with barrier layers of metal nitrides or fluorides |
US8231980B2 (en) | 2008-12-03 | 2012-07-31 | Boston Scientific Scimed, Inc. | Medical implants including iridium oxide |
EP2403546A2 (en) | 2009-03-02 | 2012-01-11 | Boston Scientific Scimed, Inc. | Self-buffering medical implants |
US8071156B2 (en) | 2009-03-04 | 2011-12-06 | Boston Scientific Scimed, Inc. | Endoprostheses |
US8287937B2 (en) | 2009-04-24 | 2012-10-16 | Boston Scientific Scimed, Inc. | Endoprosthese |
EP2272547B1 (en) * | 2009-06-23 | 2017-01-11 | Biotronik VI Patent AG | Implant and method for manufacturing same |
US20110146361A1 (en) | 2009-12-22 | 2011-06-23 | Edwards Lifesciences Corporation | Method of Peening Metal Heart Valve Stents |
US8668732B2 (en) | 2010-03-23 | 2014-03-11 | Boston Scientific Scimed, Inc. | Surface treated bioerodible metal endoprostheses |
WO2014087414A1 (en) | 2012-12-03 | 2014-06-12 | Amrita Vishwa Vidya Peetham University | Metallic titanium -based cardiovascular stent with nano - structured surface and method of manufacturing thereof |
Family Cites Families (26)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US3969195A (en) * | 1971-05-07 | 1976-07-13 | Siemens Aktiengesellschaft | Methods of coating and surface finishing articles made of metals and their alloys |
CA2087132A1 (en) * | 1992-01-31 | 1993-08-01 | Michael S. Williams | Stent capable of attachment within a body lumen |
US6174329B1 (en) * | 1996-08-22 | 2001-01-16 | Advanced Cardiovascular Systems, Inc. | Protective coating for a stent with intermediate radiopaque coating |
US6099561A (en) * | 1996-10-21 | 2000-08-08 | Inflow Dynamics, Inc. | Vascular and endoluminal stents with improved coatings |
IT1289815B1 (en) * | 1996-12-30 | 1998-10-16 | Sorin Biomedica Cardio Spa | ANGIOPLASTIC STENT AND RELATED PRODUCTION PROCESS |
US6240616B1 (en) † | 1997-04-15 | 2001-06-05 | Advanced Cardiovascular Systems, Inc. | Method of manufacturing a medicated porous metal prosthesis |
US5843172A (en) * | 1997-04-15 | 1998-12-01 | Advanced Cardiovascular Systems, Inc. | Porous medicated stent |
US6273913B1 (en) * | 1997-04-18 | 2001-08-14 | Cordis Corporation | Modified stent useful for delivery of drugs along stent strut |
US5891507A (en) † | 1997-07-28 | 1999-04-06 | Iowa-India Investments Company Limited | Process for coating a surface of a metallic stent |
WO1999007308A1 (en) | 1997-08-08 | 1999-02-18 | Sunscope International, Inc. | Microporous stent and implantation device |
US5972027A (en) † | 1997-09-30 | 1999-10-26 | Scimed Life Systems, Inc | Porous stent drug delivery system |
FR2775919B1 (en) * | 1998-03-13 | 2000-06-02 | Virsol | PROCESS OF "MECANO-CHEMICAL" TREATMENT OF A MATERIAL |
DE19916086B4 (en) * | 1998-04-11 | 2004-11-11 | Inflow Dynamics Inc. | Implantable prosthesis, especially vascular prosthesis (stent) |
US6217607B1 (en) | 1998-10-20 | 2001-04-17 | Inflow Dynamics Inc. | Premounted stent delivery system for small vessels |
US6254631B1 (en) | 1999-09-23 | 2001-07-03 | Intratherapeutics, Inc. | Stent with enhanced friction |
US6387123B1 (en) * | 1999-10-13 | 2002-05-14 | Advanced Cardiovascular Systems, Inc. | Stent with radiopaque core |
US6254632B1 (en) * | 2000-09-28 | 2001-07-03 | Advanced Cardiovascular Systems, Inc. | Implantable medical device having protruding surface structures for drug delivery and cover attachment |
US6805898B1 (en) * | 2000-09-28 | 2004-10-19 | Advanced Cardiovascular Systems, Inc. | Surface features of an implantable medical device |
JP4583756B2 (en) † | 2000-10-31 | 2010-11-17 | クック インコーポレイテッド | Medical instruments |
US20020103526A1 (en) * | 2000-12-15 | 2002-08-01 | Tom Steinke | Protective coating for stent |
US20020082679A1 (en) * | 2000-12-22 | 2002-06-27 | Avantec Vascular Corporation | Delivery or therapeutic capable agents |
DE10107339A1 (en) † | 2001-02-16 | 2002-09-05 | Jomed Gmbh | Implant used for treating vascular narrowing or occlusion, especially for controlling restenosis contains FK506 in chemically bound or physically fixed form |
CA2435306C (en) * | 2001-02-16 | 2010-12-21 | Stephan Wnendt | Implants with fk506 |
US6764505B1 (en) * | 2001-04-12 | 2004-07-20 | Advanced Cardiovascular Systems, Inc. | Variable surface area stent |
EP1254673B1 (en) * | 2001-05-02 | 2005-11-09 | InFlow Dynamics, Inc. | Immuno-tolerant stent with surface microstructure |
DE20200220U1 (en) † | 2002-01-08 | 2002-03-21 | Translumina Gmbh | stent |
-
2002
- 2002-09-20 AT AT02021067T patent/ATE392864T1/en not_active IP Right Cessation
- 2002-09-20 EP EP02021067A patent/EP1402849B2/en not_active Expired - Lifetime
- 2002-09-20 DE DE60226236T patent/DE60226236T3/en not_active Expired - Lifetime
-
2003
- 2003-09-22 JP JP2004537145A patent/JP2005538790A/en active Pending
- 2003-09-22 CA CA2497602A patent/CA2497602C/en not_active Expired - Lifetime
- 2003-09-22 WO PCT/EP2003/010542 patent/WO2004026177A1/en active Application Filing
- 2003-09-22 US US10/528,352 patent/US20060155361A1/en not_active Abandoned
- 2003-09-22 AU AU2003271633A patent/AU2003271633A1/en not_active Abandoned
-
2013
- 2013-12-19 US US14/135,257 patent/US20140180433A1/en not_active Abandoned
Cited By (11)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8574615B2 (en) | 2006-03-24 | 2013-11-05 | Boston Scientific Scimed, Inc. | Medical devices having nanoporous coatings for controlled therapeutic agent delivery |
US8815275B2 (en) | 2006-06-28 | 2014-08-26 | Boston Scientific Scimed, Inc. | Coatings for medical devices comprising a therapeutic agent and a metallic material |
US8771343B2 (en) | 2006-06-29 | 2014-07-08 | Boston Scientific Scimed, Inc. | Medical devices with selective titanium oxide coatings |
US8353949B2 (en) | 2006-09-14 | 2013-01-15 | Boston Scientific Scimed, Inc. | Medical devices with drug-eluting coating |
US8431149B2 (en) | 2007-03-01 | 2013-04-30 | Boston Scientific Scimed, Inc. | Coated medical devices for abluminal drug delivery |
US9284409B2 (en) | 2007-07-19 | 2016-03-15 | Boston Scientific Scimed, Inc. | Endoprosthesis having a non-fouling surface |
US8815273B2 (en) | 2007-07-27 | 2014-08-26 | Boston Scientific Scimed, Inc. | Drug eluting medical devices having porous layers |
US8900292B2 (en) | 2007-08-03 | 2014-12-02 | Boston Scientific Scimed, Inc. | Coating for medical device having increased surface area |
US8920491B2 (en) | 2008-04-22 | 2014-12-30 | Boston Scientific Scimed, Inc. | Medical devices having a coating of inorganic material |
US8932346B2 (en) | 2008-04-24 | 2015-01-13 | Boston Scientific Scimed, Inc. | Medical devices having inorganic particle layers |
US8449603B2 (en) | 2008-06-18 | 2013-05-28 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
Also Published As
Publication number | Publication date |
---|---|
AU2003271633A1 (en) | 2004-04-08 |
DE60226236T2 (en) | 2009-07-23 |
ATE392864T1 (en) | 2008-05-15 |
DE60226236T3 (en) | 2011-12-15 |
JP2005538790A (en) | 2005-12-22 |
US20060155361A1 (en) | 2006-07-13 |
EP1402849B2 (en) | 2011-03-16 |
EP1402849A1 (en) | 2004-03-31 |
WO2004026177A1 (en) | 2004-04-01 |
CA2497602A1 (en) | 2004-04-01 |
DE60226236D1 (en) | 2008-06-05 |
US20140180433A1 (en) | 2014-06-26 |
EP1402849B1 (en) | 2008-04-23 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
CA2497602C (en) | Stent with rough surface and its manufacture | |
US7803181B2 (en) | Ostial stent | |
CA2657682C (en) | Stent | |
US7713297B2 (en) | Drug-releasing stent with ceramic-containing layer | |
EP2324866B1 (en) | Angioplasty balloons drug-coated in an expanded condition | |
EP1981578B1 (en) | Biodegradable device | |
US8100963B2 (en) | Biodegradable device | |
JP4894519B2 (en) | Indwelling stent | |
US8769794B2 (en) | Specially configured and surface modified medical device with certain design features that utilize the intrinsic properties of tungsten, zirconium, tantalum and/or niobium | |
US20040088038A1 (en) | Porous metal for drug-loaded stents | |
US20090287301A1 (en) | Coating for medical implants | |
WO2005011796A1 (en) | Stent to be placed in vivo | |
WO2008094504A1 (en) | Medical prosthesis and method of production | |
EP1586346A1 (en) | Indwelling stent | |
CA2680229A1 (en) | Bioabsorbable coatings for medical devices | |
JP2004261567A (en) | Stent | |
WO2002013883A2 (en) | Drug-eluting membrane for coronary artery stent | |
JP2010503468A (en) | Medical device with a porous surface | |
EP1611920A1 (en) | Stent | |
WO2006027994A1 (en) | Indwelling stent | |
JP2005328893A (en) | Strut and stent | |
US20070239268A1 (en) | Adhesion resistant implantable device | |
JP2005160600A (en) | Liquid impregnating stent and liquid medication impregnating stent | |
JP2004313322A (en) | Method of manufacturing stent |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
MKEX | Expiry |
Effective date: 20230922 |