CA2436241A1 - Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same - Google Patents
Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same Download PDFInfo
- Publication number
- CA2436241A1 CA2436241A1 CA002436241A CA2436241A CA2436241A1 CA 2436241 A1 CA2436241 A1 CA 2436241A1 CA 002436241 A CA002436241 A CA 002436241A CA 2436241 A CA2436241 A CA 2436241A CA 2436241 A1 CA2436241 A1 CA 2436241A1
- Authority
- CA
- Canada
- Prior art keywords
- channel
- stent
- biologically active
- active material
- covering
- 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.)
- Abandoned
Links
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
- 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
-
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
-
- 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
- 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
- A61F2/02—Prostheses implantable into the body
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/072—Encapsulated stents, e.g. wire or whole stent embedded in lining
-
- 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
- A61F2002/91533—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 characterised by the phase between adjacent bands
- A61F2002/91541—Adjacent bands are arranged out of phase
-
- 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
- A61F2002/9155—Adjacent bands being connected to each other
- A61F2002/91558—Adjacent bands being connected to each other connected peak to peak
-
- 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
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0002—Two-dimensional shapes, e.g. cross-sections
- A61F2230/0004—Rounded shapes, e.g. with rounded corners
- A61F2230/0013—Horseshoe-shaped, e.g. crescent-shaped, C-shaped, U-shaped
-
- 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into 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
- A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
- A61F2250/0067—Means for introducing or releasing pharmaceutical products into the body
- A61F2250/0068—Means for introducing or releasing pharmaceutical products into the body the pharmaceutical product being in a reservoir
Abstract
An implantable stent prosthesis comprises a sidewall and at least one channel for containing a biologically active material. A method for making such stent prosthesis is also disclosed. In the method, at least one tube or mandrel is placed in contact with a covering material on a stent and surrounded by the covering material to form a channel. Alternatively, a channel can be formed by covering tube or mandrel with a channel material and exposing the covered tube or mandrel to an appropriate treatment. The channel can be attached to a sidewall of a stent or attached to a strut material to form a stent wire. A
method of treating an afflicted area of a body lumen by implanting the stent prosthesis is also disclosed.
method of treating an afflicted area of a body lumen by implanting the stent prosthesis is also disclosed.
Description
STENT WITH CHANNELS) FOR CONTAINING
AND DELIVERING A BIOLOGICALLY ACTIVE MATERIAL
AND METHOD FOR MANUFACTURING THE SAME
FIELD OF THE INVENTION
This invention relates generally to an implantable medical device for delivering biologically active materials. More specifically, the invention relates to an implantable stmt prosthesis for delivering a biologically active material and a method for manufacturing the same. More particularly, the invention is directed to a stmt having one or more channels for containing and delivering a biologically active material.
BACKGROUND OF THE INVENTION
Balloon angioplasty has been very effective in treating stenosis, i.e., to open blocked vessels and restore normal levels of blood flow. However, although once a blocked vessel is opened, the treated vessel has a tendency to restenose, i.e., recluse, shortly after the procedure. Thus, patients have to repeatedly be treated with angioplasty or surgery.
Implantable stmt prosthesis or stems are used to reduce restenosis after balloon angioplasty or other procedures using catheters. A stmt in the form of a wire mesh tube props open an artery that has recently been cleared using angioplasty.
The stmt is collapsed to a.small diameter, placed over an angioplasty balloon catheter and moved into the area of the blockage. When the balloon is inflated, the stmt expands, locks in place and forms a scaffold to hold the artery open. Usually, the stmt stays in the artery permanently, holds it open, improves blood flow to the heart muscle and relieves symptoms.
The stmt procedure is fairly common, and various types of stems have been developed and actually used.
However, the metal surfaces of stems currently in use may trigger restenosis.
To prevent the stented arteries from reclosing, patients who receive stems must take one or more anticoagulating drugs, such as heparin, aspirin, coumadin, dextran, and/or persantine even though systemic application of anticoagulants has been known to cause bleeding complications.
To reduce the likelihood of restenosis caused by the metal surface of such stems, stems covered with polymers and a drug have been offered. However, those covered stems are still not completely satisfactory. Therefore, there is a need for additional devices or methods to reduce the necessity for systemic application of anticoagulants and alleviate restenosis.
Further, for certain diseases which are localized to a particular part of body, the systemic administration of a biologically active material for the treatment of these diseases may not be preferred because of the inefficiencies associated with the indirect delivery of the biologically active material to the afflicted area. Therefore, there is a need for a device or method to deliver the biologically active material directly to a particular part of the body.
SUMMARY OF THE INVENTION
These and other objects are accomplished by the present invention. To achieve the aforementioned objectives, we have invented an implantable stmt prosthesis with channels and methods for manufacturing the same.
The implantable stmt prosthesis of the present invention comprises a sidewall and at least one channel for containing a biologically active material, wherein the sidewall comprises at least in part a plurality of struts having an exterior surface.
The present invention also includes a method for making such implantable stmt prosthesis: In an embodiment, at least one tube or mandrel is placed in contact with a covering material on a stmt. The tube or mandrel is surrounded by the covering material, and then a channel is formed so that it is located within the covering material and wherein the channel has two open ends.
In another embodiment, a tube or mandrel is covered with a channel material. The covered tube or mandrel is exposed to either heat treatment, chemical treatment or treatment with an adhesive, to form a channel having two open ends. The channel is attached to a sidewall of a stmt.
Further, in another embodiment, a tube or mandrel is covered with a channel material. The covered tube or mandrel is exposed to either heat treatment, chemical treatment or treatment with an adhesive, to form a channel having two open ends. The channel is attached to a strut material to form a stmt wire. The stmt wire is woven to form 30 the sidewall of the stmt.
The present invention also includes a method of treating an afflicted area of a surface of a body lumen by implanting the stent prosthesis containing a biologically active material. The biologically active material is delivered to the afflicted area.
AND DELIVERING A BIOLOGICALLY ACTIVE MATERIAL
AND METHOD FOR MANUFACTURING THE SAME
FIELD OF THE INVENTION
This invention relates generally to an implantable medical device for delivering biologically active materials. More specifically, the invention relates to an implantable stmt prosthesis for delivering a biologically active material and a method for manufacturing the same. More particularly, the invention is directed to a stmt having one or more channels for containing and delivering a biologically active material.
BACKGROUND OF THE INVENTION
Balloon angioplasty has been very effective in treating stenosis, i.e., to open blocked vessels and restore normal levels of blood flow. However, although once a blocked vessel is opened, the treated vessel has a tendency to restenose, i.e., recluse, shortly after the procedure. Thus, patients have to repeatedly be treated with angioplasty or surgery.
Implantable stmt prosthesis or stems are used to reduce restenosis after balloon angioplasty or other procedures using catheters. A stmt in the form of a wire mesh tube props open an artery that has recently been cleared using angioplasty.
The stmt is collapsed to a.small diameter, placed over an angioplasty balloon catheter and moved into the area of the blockage. When the balloon is inflated, the stmt expands, locks in place and forms a scaffold to hold the artery open. Usually, the stmt stays in the artery permanently, holds it open, improves blood flow to the heart muscle and relieves symptoms.
The stmt procedure is fairly common, and various types of stems have been developed and actually used.
However, the metal surfaces of stems currently in use may trigger restenosis.
To prevent the stented arteries from reclosing, patients who receive stems must take one or more anticoagulating drugs, such as heparin, aspirin, coumadin, dextran, and/or persantine even though systemic application of anticoagulants has been known to cause bleeding complications.
To reduce the likelihood of restenosis caused by the metal surface of such stems, stems covered with polymers and a drug have been offered. However, those covered stems are still not completely satisfactory. Therefore, there is a need for additional devices or methods to reduce the necessity for systemic application of anticoagulants and alleviate restenosis.
Further, for certain diseases which are localized to a particular part of body, the systemic administration of a biologically active material for the treatment of these diseases may not be preferred because of the inefficiencies associated with the indirect delivery of the biologically active material to the afflicted area. Therefore, there is a need for a device or method to deliver the biologically active material directly to a particular part of the body.
SUMMARY OF THE INVENTION
These and other objects are accomplished by the present invention. To achieve the aforementioned objectives, we have invented an implantable stmt prosthesis with channels and methods for manufacturing the same.
The implantable stmt prosthesis of the present invention comprises a sidewall and at least one channel for containing a biologically active material, wherein the sidewall comprises at least in part a plurality of struts having an exterior surface.
The present invention also includes a method for making such implantable stmt prosthesis: In an embodiment, at least one tube or mandrel is placed in contact with a covering material on a stmt. The tube or mandrel is surrounded by the covering material, and then a channel is formed so that it is located within the covering material and wherein the channel has two open ends.
In another embodiment, a tube or mandrel is covered with a channel material. The covered tube or mandrel is exposed to either heat treatment, chemical treatment or treatment with an adhesive, to form a channel having two open ends. The channel is attached to a sidewall of a stmt.
Further, in another embodiment, a tube or mandrel is covered with a channel material. The covered tube or mandrel is exposed to either heat treatment, chemical treatment or treatment with an adhesive, to form a channel having two open ends. The channel is attached to a strut material to form a stmt wire. The stmt wire is woven to form 30 the sidewall of the stmt.
The present invention also includes a method of treating an afflicted area of a surface of a body lumen by implanting the stent prosthesis containing a biologically active material. The biologically active material is delivered to the afflicted area.
-2-DESCRIPTION OF THE DRAWINGS
Figures 1A, 1B, 1C and 1D show embodiments of a stmt with channel for containing a biologically active material where the stmt covering material forms the channel wall defining the channel. Figure 1A shows a cross-sectional view of such an embodiment. In the embodiment, an end of the outer (first) cover is folded to form the channel, i.e., the channel is formed between two layers of covering material.
Figure 1B
depicts a cross-sectional view of another embodiment of the invention where a middle portion of the outer stmt covering is used to form the channel wall. Figure 1C
depicts a cross-sectional view of an embodiment of the invention where an inner (second) covering is used to form the channel wall. Figure 1D depicts a cross-sectional view of an embodiment of the invention which is similar to that of Figure 1B. In Figure 1B, the channel wall is formed by the outer cover in its entirety. On the other hand, the channel wall in Figure 1D
is formed by the outer cover in part and by the stmt sidewall in part.
Figure 2 depicts a perspective view of another embodiment of a stmt with a channel positioned along a circumference of the stmt.
Figures 3A and 3B illustrate perspective views of embodiments of a stmt of the invention wherein a channel is woven with the struts or wires of a stmt.
Figure 4A illustrates a stmt wherein a channel is fused to the stmt struts.
Figure 4B is a cross-sectional view at the line D in Figure 4A of the stmt strut and the channel.
Figure 5 depicts a cross sectional view of a channel and positioned between two layers of a stmt covering.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
An embodiment of the present invention is illustrated in Figure 1A. Figure 1A shows a stmt 10 having a sidewall 16, made up of a plurality of struts 13.
In the embodiment, an exterior surface of the stmt sidewall 16 is covered with a first stmt covering 12, and an interior luminal surface of the stent sidewall 16 is covered with a second stmt covering 14. In this embodiment, the channel is formed by folding one end of the first stmt covering 12 to form a channel 15. In this case, the channel wall 15a, which encompasses the space in the channel 15, is formed of the covering material.
The term "channel" refers to a tube-like pocket along with the channel wall defining such pocket or space, i.e., the channel comprises both the channel wall and the pocket defined by the channel wall. In this embodiment, the channel 15 is positioned along the longitudinal axis
Figures 1A, 1B, 1C and 1D show embodiments of a stmt with channel for containing a biologically active material where the stmt covering material forms the channel wall defining the channel. Figure 1A shows a cross-sectional view of such an embodiment. In the embodiment, an end of the outer (first) cover is folded to form the channel, i.e., the channel is formed between two layers of covering material.
Figure 1B
depicts a cross-sectional view of another embodiment of the invention where a middle portion of the outer stmt covering is used to form the channel wall. Figure 1C
depicts a cross-sectional view of an embodiment of the invention where an inner (second) covering is used to form the channel wall. Figure 1D depicts a cross-sectional view of an embodiment of the invention which is similar to that of Figure 1B. In Figure 1B, the channel wall is formed by the outer cover in its entirety. On the other hand, the channel wall in Figure 1D
is formed by the outer cover in part and by the stmt sidewall in part.
Figure 2 depicts a perspective view of another embodiment of a stmt with a channel positioned along a circumference of the stmt.
Figures 3A and 3B illustrate perspective views of embodiments of a stmt of the invention wherein a channel is woven with the struts or wires of a stmt.
Figure 4A illustrates a stmt wherein a channel is fused to the stmt struts.
Figure 4B is a cross-sectional view at the line D in Figure 4A of the stmt strut and the channel.
Figure 5 depicts a cross sectional view of a channel and positioned between two layers of a stmt covering.
DESCRIPTION OF THE PREFERRED EMBODIMENTS
An embodiment of the present invention is illustrated in Figure 1A. Figure 1A shows a stmt 10 having a sidewall 16, made up of a plurality of struts 13.
In the embodiment, an exterior surface of the stmt sidewall 16 is covered with a first stmt covering 12, and an interior luminal surface of the stent sidewall 16 is covered with a second stmt covering 14. In this embodiment, the channel is formed by folding one end of the first stmt covering 12 to form a channel 15. In this case, the channel wall 15a, which encompasses the space in the channel 15, is formed of the covering material.
The term "channel" refers to a tube-like pocket along with the channel wall defining such pocket or space, i.e., the channel comprises both the channel wall and the pocket defined by the channel wall. In this embodiment, the channel 15 is positioned along the longitudinal axis
-3-of the stmt. When the stmt is introduced into a body lumen, the channel 15 contains biologically active material, and both ends of the channel 15 are preferably sealed.
The stmt 10 may be prepared by the following steps:
(1) A stmt is manufactured by a method known in the art and a stmt covering 12 is disposed about the exterior surface of the stmt sidewall 16.
(2) A tube or tube-like object having the desired diameter or width or shape is placed on top of the exterior surface of the stmt covering near the end of the covering. The covering is then folded around or made to surround the tube, so that an end of the tube protrudes from a first end of the channel 15.
(3) The folded cover is treated by heat or chemical treatment or an adhesive or other method known in the art to form a channel 15 having a channel wall 15a made of the covering material. At this point, the second end of the channel 15 can be sealed by heat-fusing or adhesive or other method known in the art.
The stmt 10 may be prepared by the following steps:
(1) A stmt is manufactured by a method known in the art and a stmt covering 12 is disposed about the exterior surface of the stmt sidewall 16.
(2) A tube or tube-like object having the desired diameter or width or shape is placed on top of the exterior surface of the stmt covering near the end of the covering. The covering is then folded around or made to surround the tube, so that an end of the tube protrudes from a first end of the channel 15.
(3) The folded cover is treated by heat or chemical treatment or an adhesive or other method known in the art to form a channel 15 having a channel wall 15a made of the covering material. At this point, the second end of the channel 15 can be sealed by heat-fusing or adhesive or other method known in the art.
(4) A biologically active material can be placed into the channel 15 by injection or other appropriate means known to the skilled artisan. Preferably, the biologically active material is placed into the channel 15 at the first end of the channel as the tube is being removed. Then the first end of the channel 15 can also be sealed.
The last step, placement of a biologically active material into the channel, is not necessarily conducted'by a manufacturer but can be done by a user of the devices just prior to implantation. Thus, the stmt of the present invention includes a stmt with a channel, where only one end is sealed or both ends are open, without any biologically active material contained in the channel. The user would then place a biologically active material into the channel, right before insertion of the stmt into a body lumen.
A mandrel can be used to form the channel instead of a tube. Preferably, the mandrel is made of a material which is easily dissolvable in a solvent. When the mandrel is soluble in water or an organic solvent, it can be removed from the channel by dipping the channel containing the mandrel and dissolving the mandrel in water or solvent.
Also, the mandrel can contain the biologically active material, and in that case there is no need to remove the mandrel from the channel and no need to later fill the channel with a biologically active material. The mandrel can also be made of a material that is insoluble, such as a plastic or metal, and can be removed leaving the open channel.
Also the channel 15 need not be positioned near the end of the covering and can be positioned in the middle of the first covering 12 as shown in Figure 1B. In this case, a tube or mandrel is positioned between the stmt sidewall 16 and the first covering 12 as shown in Figure 1B. Also, as shown in Figure 1C, the channel 15 can be made from the second, inner, stmt covering 14 in the same way as explained above with respect to the first stmt covering 12. Moreover, the channel 15 can be formed by the coverings 12, 14 in part and the stmt sidewall 16 in part as shown in Figure 1D.
Another embodiment of the invention is illustrated in Figure 2. In this embodiment, the channel 26 is positioned along a circumference of the stmt 20.
Such channel 26 can be made in the same way as explained above, i.e., by inserting a tube or mandrel between the stmt sidewall 27 the first stmt covering 22 or between layers of the stmt covering and then placing the first stmt covering 22 material around the tube or mandrel, to form a channel 26. The covering surrounding the tube or mandrel can be treated by heat, chemical or adhesive to form the channel 26. One end of the tube or mandrel may be left protruding from a first open end of the channel 26 and second open end of the channel 26 is sealed by an appropriate means, such as by heat or chemical treatment or by adhesives. Then, a biologically active material is placed into the channel 26 at the first open end. The tube or mandrel is taleen out of the channel 26, and the first end of the channel 26 can be sealed. Lileewise, the channel 26 can be positioned about the outer surface or inner luminal surface of the stmt sidewall 27 in a spiral-lilee manner.
In addition, besides being formed of a stmt covering material, channels 15, 26 may be formed from a layer of a channel material. First, a channel 15, 26 is prepared by wrapping a tube or mandrel with a layer of channel material, i.e., the channel wall is formed of the channel material. More than one layer can be used. These layers need not be of the same type of material. The types of materials used for the layers can be selected to affect the release rate of the biologically active materials. The channel 15, 26 is positioned in the stmt covering material and attached or fused to the covering material by heat or chemical treatment or by using an adhesive. A material used for forming the channel can be the same as or different from the material for the stmt coverings 2, 14, 22, 24.
Also, channel 34 made from the channel material can be used to form the stmt sidewall 34. In Figures 3A and 3B, the channel 34 is produced separately, and then woven with the struts 32 to form the stmt sidewall. Alternatively, the channel 34 can be woven into a prefabricated stmt 30A, 30B comprising struts 32. In Figure 3A, the channel 34 is woven into the stmt 30A along the stems longitudinal axis. In Figure 3B, the channel 34 is woven into the stmt 30B along a circumference of the stmt 30. The channel can also be woven in other configurations, such as in a spiral manner. These stems having sidewalls comprising channels woven with the stmt struts can be covered with a covering material
The last step, placement of a biologically active material into the channel, is not necessarily conducted'by a manufacturer but can be done by a user of the devices just prior to implantation. Thus, the stmt of the present invention includes a stmt with a channel, where only one end is sealed or both ends are open, without any biologically active material contained in the channel. The user would then place a biologically active material into the channel, right before insertion of the stmt into a body lumen.
A mandrel can be used to form the channel instead of a tube. Preferably, the mandrel is made of a material which is easily dissolvable in a solvent. When the mandrel is soluble in water or an organic solvent, it can be removed from the channel by dipping the channel containing the mandrel and dissolving the mandrel in water or solvent.
Also, the mandrel can contain the biologically active material, and in that case there is no need to remove the mandrel from the channel and no need to later fill the channel with a biologically active material. The mandrel can also be made of a material that is insoluble, such as a plastic or metal, and can be removed leaving the open channel.
Also the channel 15 need not be positioned near the end of the covering and can be positioned in the middle of the first covering 12 as shown in Figure 1B. In this case, a tube or mandrel is positioned between the stmt sidewall 16 and the first covering 12 as shown in Figure 1B. Also, as shown in Figure 1C, the channel 15 can be made from the second, inner, stmt covering 14 in the same way as explained above with respect to the first stmt covering 12. Moreover, the channel 15 can be formed by the coverings 12, 14 in part and the stmt sidewall 16 in part as shown in Figure 1D.
Another embodiment of the invention is illustrated in Figure 2. In this embodiment, the channel 26 is positioned along a circumference of the stmt 20.
Such channel 26 can be made in the same way as explained above, i.e., by inserting a tube or mandrel between the stmt sidewall 27 the first stmt covering 22 or between layers of the stmt covering and then placing the first stmt covering 22 material around the tube or mandrel, to form a channel 26. The covering surrounding the tube or mandrel can be treated by heat, chemical or adhesive to form the channel 26. One end of the tube or mandrel may be left protruding from a first open end of the channel 26 and second open end of the channel 26 is sealed by an appropriate means, such as by heat or chemical treatment or by adhesives. Then, a biologically active material is placed into the channel 26 at the first open end. The tube or mandrel is taleen out of the channel 26, and the first end of the channel 26 can be sealed. Lileewise, the channel 26 can be positioned about the outer surface or inner luminal surface of the stmt sidewall 27 in a spiral-lilee manner.
In addition, besides being formed of a stmt covering material, channels 15, 26 may be formed from a layer of a channel material. First, a channel 15, 26 is prepared by wrapping a tube or mandrel with a layer of channel material, i.e., the channel wall is formed of the channel material. More than one layer can be used. These layers need not be of the same type of material. The types of materials used for the layers can be selected to affect the release rate of the biologically active materials. The channel 15, 26 is positioned in the stmt covering material and attached or fused to the covering material by heat or chemical treatment or by using an adhesive. A material used for forming the channel can be the same as or different from the material for the stmt coverings 2, 14, 22, 24.
Also, channel 34 made from the channel material can be used to form the stmt sidewall 34. In Figures 3A and 3B, the channel 34 is produced separately, and then woven with the struts 32 to form the stmt sidewall. Alternatively, the channel 34 can be woven into a prefabricated stmt 30A, 30B comprising struts 32. In Figure 3A, the channel 34 is woven into the stmt 30A along the stems longitudinal axis. In Figure 3B, the channel 34 is woven into the stmt 30B along a circumference of the stmt 30. The channel can also be woven in other configurations, such as in a spiral manner. These stems having sidewalls comprising channels woven with the stmt struts can be covered with a covering material
-5-(not shown). The biologically active material can be placed into the channel before or after the channel is woven into the stmt.
Figures 4A illustrates another embodiment of the invention wherein a piece stmt strut material 43 and a channel 46 are combined or fused together to form a stmt wire 42. These wires are used to form the sidewall of he stmt 40. The stent may also be coated with a covering material (not shown in Figure 4A). Figure 4B shows a cross-sectional view of such a stmt wire 42 comprising strut material 43 and a channel 46 coated together with a covering material 48. Either the entire stmt sidewall or a part thereof can be made up of such stmt wires 42. The covering material may be placed over the strut material 43 and channe1.46 before or after they are used to make the stmt sidewall.
One of the methods for producing the stmt 40 comprises the following steps:
forming a channel 46 by wrapping a tube or mandrel 47 with a channel wall material and fusing the channel 46 to the strut material 43. The channel 46 and strut material are coated with a covering material 48. As the tube or mandrel 47 is removed, a biologically active material is placed into the channel 46 and both ends of the channel can be sealed by an appropriate means, such as with chemical treatment or by heat. The coated stmt wire 42 is woven into the stmt 40. The order of the steps is totally interchangeable. For example, the coating step is not necessarily before the weaving step. Also, the step of placing the biologically active material can be done after the weaving step. The biologically active material can be introduced into the channel by diffusion in a solution/vapor or migration.
Also, in another embodiment, a channel made of a channel material can be fused to the struts of a prefabricated stmt.
In Figure 5, a channel 57 is inserted between two layers 52 and 53 of a stmt covering material. The channel 56 containing a tube or mandrel 57 may be separately prepared from a layer of channel material and inserted into the two covers 52 and 53 which are covering a stmt. Alternatively, a stmt cover 50 wherein two cover layers 52 and 53 are sandwiching a channel 56 is formed first, and then the cover 50 may be placed onto a stmt.
If the material for the channel cannot withstand the heat or other treatment used for processing the stmt covering, the channel may be formed separately from a channel material and then inserted into another channel which is formed with the stmt covering material as explained above.
In another embodiment of the present invention, the tent-like space formed between (a) stmt cover layers) and a stmt strut can be used as a channel for containing a biologically active material. The tent-like space can be enlarged by inserting a tube of desired diameter into it.
_6_ A stmt can have more than one channel. Each channel can be made of an identical material or different materials and also by an identical method or different methods.
The following is a more detailed description of suitable materials and method useful in producing a stent with channels) of the invention.
The term "biologically active material" encompasses therapeutic agents, such as drugs, and also genetic materials and biological materials. The genetic materials mean DNA or RNA, including, without limitation, of DNA/RNA encoding a useful protein stated below, intended to be inserted into a human body including viral vectors and non-viral vectors. Viral vectors include adenoviruses, gutted adenoviruses, adeno-associated virus, retroviruses, alpha virus (Semliki Forest, Sindbis, etc.), lentiviruses, herpes simplex virus, ex vivo modified cells (e.g., stem cells, fibroblasts, myoblasts, satellite cells, pericytes, cardiomyocytes, sketetal myocytes, macrophage), replication competent viruses (e.g., ONYK-015), and hybrid vectors. Non-viral vectors include artificial chromosomes and mini-chromosomes, plasmid DNA vectors (e.g., pCOR), cationic polymers (e.g., polyethyleneimine, polyethyleneimine (PEI)) graft copolymers (e.g., polyether-PEI and polyethylene oxide-PEI), neutral polymers PVP, SP1017 (SUPRATEK), lipids or lipoplexes, nanoparticles and microparticles with and without targeting sequences such as the protein transduction domain (PTD). The biological materials include cells, yeasts;
bacteria, proteins, peptides, cytokines and hormones. Examples for peptides and proteins include growth factors (FGF, FGF-1, FGF-2, VEGF, Endotherial Mitogenic Growth Factors, and epidermal growth factors, transforming growth factor a and (3, platelet derived endothelial growth factor, platelet derived growth factor, tumor necrosis factor a, hepatocyte growth factor and insulin like growth factor ), transcription factors, proteinkinases, CD inhibitors, thymidine kinase, and bone morphogenic proteins (BMP's), such as BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (Vgr-1), BMP-7 (OP-1), BMP-8. BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, B1VIP-15, and BMP-16. Currently preferred BMP's are BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7. These dimeric proteins can be provided as homodimers, heterodimers, or combinations thereof, alone or together with other molecules. Cells can be of human origin (autologous or allogeneic) or from an animal source (xenogeneic), genetically engineered, if desired, to deliver proteins of interest at the transplant site. The delivery media can be formulated as needed to maintain cell function and viability. Cells include whole bone marrow, bone marrow derived mono-nuclear cells, progenitor cells (e.g., endothelial progentitor cells) stem cells (e.g., mesenchymal, hematopoietic, neuronal), pluripotent stem cells, fibroblasts, macrophage, and satellite cells.
_7_ Biologically active material also includes non-genetic therapeutic agents, such as:
~ anti-thrombogenic agents such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone);
~ anti-proliferative agents such as enoxaprin, angiopeptin, or monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid, amlodipine and doxazosin;
~ anti-inflammatory agents such as glucocorticoids, betamethasone, dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine;
~ antineoplastic/antiproliferativelanti-miotic agents such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, methotrexate, azathioprine, adriamycin and mutamycin; endostatin, angiostatin and thymidine kinase inhibitors, taxol and its analogs or derivatives;
~ anesthetic agents such as lidocaine, bupivacaine, and ropivacaine;
~ anti-coagulants such as D-Phe-Pro-Arg chloromethyl keton, an RGD
peptide-containing compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-thrombin anticodies, anti-platelet receptor antibodies, aspirin (aspirin is also classified as an analgesic, antipyretic and anti-inflammatory drug), dipyridamole, protainine, hirudin, prostaglandin inhibitors platelet inhibitors and tick antiplatelet peptides;
vascular cell growth promotors such as growth factors, Vascular Endothelial Growth Factors (FEGF, all types including VEGF-2), growth factor receptors, transcriptional activators, and translational promotors;
~ vascular cell growth inhibitors such as antiproliferative agents, growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin;
~ cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vasoactive mechanisms;
~ anti-oxidants, such as probucol;
~ antibiotic agents, such as penicillin, cefoxitin, oxacillin, tobranycin ~ angiogenic substances, such as acidic and basic fibrobrast growth factors, estrogen including estradiol (E2), estriol (E3) and 17-Beta Estradiol; and ~ drugs for heart failure, such as digoxin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors including captopril and enalopril.
_g_ A biologically active material can be placed into the channel by various methods including injection as explained above. For instance, after the biologically active material is dissolved or suspended in water or an aqueous solution, it can be injected into the channel. Also, the biologically active material can be introduced into a channel by diffusion in the solution. For example, a stmt with an empty channel is dipped in a solution or suspensions of the biologically active material to allow the biologically active material to diffuse into the channel. Also, when the biologically active material is dissolved in an organic solvent, it can be introduced into a channel by diffusion in a vapor of the solvent solution. When the biologically active material is a biological material, such as tissue culture cells, yeast, and bacteria, it can be introduced into a channel by migration or by injection of a culture medium containing the biological material.
Stems suitable for the present invention include any stmt for medical purpose without limitation, which are known to the skilled artisan. Stems suitable for the present invention include vascular stems such as self-expanding stems and balloon expandable stems. Examples of self expanding stems useful in the present invention are illustrated in U.S. Patent Nos. 4,655,771 and 4,954,126 issued to Wallsten and 5,061,275 issued to Wallsten et al. Examples of appropriate balloon-expandable stems are shown in U.S. Patent No. 4,733,665 issued to Palmaz, U.S. Patent No. 4,800,882 issued to Gianturco and U.S. Patent No. 4,886,062 issued to Wiktor. Expandable stmt may be formed from polymeric, metallic and/or ceramic materials. Suitable materials include, without limitation, metals, such as tantalum, stainless steel, nitinol, titanium, and alloys, and polymeric materials, such as poly-L-lactic acid, polycarbonate, and polyethylene terephtalate. Also, stems made with biostable or bioabsorbable polymers such as polyethylene terephthalate), polyacetal, poly(lactic acid), polyethylene oxide)/poly(butylene terephthalate) copolymer could be used in the present invention.
Stent covering materials suitable for the present invention include any covering material for the stmt which are known to the skilled artisan. The covering can be a polymer, which is preferably selected from elastomeric polymers, e.g., silicones, polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, EPDM rubbers, polytetrafluoroethylene (PTFE) or expanded PTFE
(ePTFE).
Suitable thickness of the cover are known in the art and can be selected by artisans. The cover can be produced by any method suitable and known in the art. For example, by dipping a stmt in a polymer, spraying a polymer covering solution onto a stmt, wrapping the stmt with a material or encapsulating the stmt in a polymer tube.
Examples for suitable materials for making the channel, i.e., channel materials, are, without limitation, poly(L-lactic acid), poly(lactic acid-co-glycotic acid), polyether, polyurethane, and silicone. The material for the channel material can be selected to control release of the drug contained in the channel. For example, in the embodiment where the channel is located in the stmt covering, the channel material and covering materials used are selected so that the biologically active material can be released at a certain rate or in a certain manner.
Preferably, the channel has a cylindrical-like shape, where the channel has a circular cross-section as shown in the figures. However, the channel need not be cylindrical. Instead, the channel can have an oblong, square or star-like shaped cross-section, or any other type of shape.
The diameter of the channel of the present invention is not limited and should be selected depending on the type and amount of biologically active material to be deliver, the rate of the delivery, and the method for manufacture. For instance, when the biologically active material is injected into the channel by a syringe rather than by diffusion, migration or by inserting a mandrel containing the biologically active material, the channel diameter should be large enough to allow such injection. When the biologically active material is placed into the channel by migration, the channel should have opening(s), i.e., an open end or pores) which are large enough for such migration of the biologically active material into and out of the channel space. Alternatively, the biological material can be trapped in the channel and prevented from migration but allowed to produce a biological active material that can actively regulate biological function. For example, growth-factor producing cells are trapped in the channel, but the growth factor that these cells produce is gradually released from the channel while the cells stay in the channel.
Moreover, the ~5 present invention may include not only macro channels but also micro channels. The micro channels may be produced by micro-fabrication, by printing a pattern on the stmt or stmt cover, or using pre-printed sheets. The macro channels maybe preferable because of their larger capacity for containing biologically active material.
The suitable diameter of the channel depends on various factors, such as the 30 material to be used to make the channel, the manner to inject the biologically active material, the thickness of the material, the size and type of the stmt, the configuration of the channel, method of manufacture, amount of the biologically active material to be deliver and the rate of the delivery. The inner diameter of the channel is normally from about 10 ~Cm to about 1 mm, preferably from about 50 ~,m to about 500 ~.m.
The thickness of the channel wall is not limited and depends on the biologically active material to be deliver, the rate of the delivery, method for manufacture, and type of channel material used. For example, when the channel material is polyethylene terephthalate), the thickness is generally between 10 p,m and 2000 ~,m, preferably between 50 p,m and 600 p,m, more preferably 50 ~m and 450 ~Cm.
The release rate of the biologically active material depends on the degree of porosity of the channel material and covering material, hydrophobicity of the channel material and covering material, the thickness of the channel wall and covering, and the biologically active material's chemical and physical features. Thus, by selecting an appropriate covering material, channel material and a thickness of the covering and/or channel wall, the release rate of a biologically active material can be controlled.
Additionally, a further control can be possible by using wide variety of pharmaceutical forms of the drugs and Garners, such as bars, particles, gels, and fluids.
The release rate of the biologically active material is not necessarily uniform.
For example, by selecting a porous material for inner covering of stmt and a less porous material for the outer covering, the release rate of the biologically active material at the interior luminal surface of the stmt is greater than at the stmt's exterior surface.
Accordingly, there can be a lag time between the implantation of the stmt and the biologically active material is first released. Alternatively, there can be a gradient for a biologically active material contained in the channel. If the concentration of the biologically active material is high in the center of the channel and becomes lower at points further from the center, the release rate can increase with time. If the concentration of the biologically active material is low in the center of the channel and becomes higher as distant from the center, the releasing rate can gradually decrease with time.
In some embodiments, the channel wall has a plurality of ports which allow a biologically active material to pass through. The biologically active material, such as tissue culture cells, yeast, bacteria can migrate through the ports. Such channel may be substantially covered with a covering.
A stmt of the present invention can be implanted into a body lumen using any conventional method known in the art. The body lumen into which the stmt can be implanted includes blood vessels, urinary tract, coronary vasculature, esophagus, trachea, colon, and biliary tract. Once the stmt with the channels) is placed in a body lumen, the biologically active material in the channel can be released from the channel by diffusion through the channel wall. In another embodiment of the present invention, a biologically active material is released from the channel by application of pressure. For example, the stmt is inserted into a body lumen by a balloon catheter and the biologically active material is squeezed out from the channel when the stmt is pressed onto the body lumen surface by expanding balloon.
The description contained herein is for purposes of illustration and not for purposes of limitation. Changes and modifications may be made to the embodiments of the description and still be within the scope of the invention. Furthermore, obvious changes, modifications or variations will occur to those skilled in the art. Also, all references cited above are incorporated herein, in their entirety, for all purposes related to this disclosure.
Figures 4A illustrates another embodiment of the invention wherein a piece stmt strut material 43 and a channel 46 are combined or fused together to form a stmt wire 42. These wires are used to form the sidewall of he stmt 40. The stent may also be coated with a covering material (not shown in Figure 4A). Figure 4B shows a cross-sectional view of such a stmt wire 42 comprising strut material 43 and a channel 46 coated together with a covering material 48. Either the entire stmt sidewall or a part thereof can be made up of such stmt wires 42. The covering material may be placed over the strut material 43 and channe1.46 before or after they are used to make the stmt sidewall.
One of the methods for producing the stmt 40 comprises the following steps:
forming a channel 46 by wrapping a tube or mandrel 47 with a channel wall material and fusing the channel 46 to the strut material 43. The channel 46 and strut material are coated with a covering material 48. As the tube or mandrel 47 is removed, a biologically active material is placed into the channel 46 and both ends of the channel can be sealed by an appropriate means, such as with chemical treatment or by heat. The coated stmt wire 42 is woven into the stmt 40. The order of the steps is totally interchangeable. For example, the coating step is not necessarily before the weaving step. Also, the step of placing the biologically active material can be done after the weaving step. The biologically active material can be introduced into the channel by diffusion in a solution/vapor or migration.
Also, in another embodiment, a channel made of a channel material can be fused to the struts of a prefabricated stmt.
In Figure 5, a channel 57 is inserted between two layers 52 and 53 of a stmt covering material. The channel 56 containing a tube or mandrel 57 may be separately prepared from a layer of channel material and inserted into the two covers 52 and 53 which are covering a stmt. Alternatively, a stmt cover 50 wherein two cover layers 52 and 53 are sandwiching a channel 56 is formed first, and then the cover 50 may be placed onto a stmt.
If the material for the channel cannot withstand the heat or other treatment used for processing the stmt covering, the channel may be formed separately from a channel material and then inserted into another channel which is formed with the stmt covering material as explained above.
In another embodiment of the present invention, the tent-like space formed between (a) stmt cover layers) and a stmt strut can be used as a channel for containing a biologically active material. The tent-like space can be enlarged by inserting a tube of desired diameter into it.
_6_ A stmt can have more than one channel. Each channel can be made of an identical material or different materials and also by an identical method or different methods.
The following is a more detailed description of suitable materials and method useful in producing a stent with channels) of the invention.
The term "biologically active material" encompasses therapeutic agents, such as drugs, and also genetic materials and biological materials. The genetic materials mean DNA or RNA, including, without limitation, of DNA/RNA encoding a useful protein stated below, intended to be inserted into a human body including viral vectors and non-viral vectors. Viral vectors include adenoviruses, gutted adenoviruses, adeno-associated virus, retroviruses, alpha virus (Semliki Forest, Sindbis, etc.), lentiviruses, herpes simplex virus, ex vivo modified cells (e.g., stem cells, fibroblasts, myoblasts, satellite cells, pericytes, cardiomyocytes, sketetal myocytes, macrophage), replication competent viruses (e.g., ONYK-015), and hybrid vectors. Non-viral vectors include artificial chromosomes and mini-chromosomes, plasmid DNA vectors (e.g., pCOR), cationic polymers (e.g., polyethyleneimine, polyethyleneimine (PEI)) graft copolymers (e.g., polyether-PEI and polyethylene oxide-PEI), neutral polymers PVP, SP1017 (SUPRATEK), lipids or lipoplexes, nanoparticles and microparticles with and without targeting sequences such as the protein transduction domain (PTD). The biological materials include cells, yeasts;
bacteria, proteins, peptides, cytokines and hormones. Examples for peptides and proteins include growth factors (FGF, FGF-1, FGF-2, VEGF, Endotherial Mitogenic Growth Factors, and epidermal growth factors, transforming growth factor a and (3, platelet derived endothelial growth factor, platelet derived growth factor, tumor necrosis factor a, hepatocyte growth factor and insulin like growth factor ), transcription factors, proteinkinases, CD inhibitors, thymidine kinase, and bone morphogenic proteins (BMP's), such as BMP-2, BMP-3, BMP-4, BMP-5, BMP-6 (Vgr-1), BMP-7 (OP-1), BMP-8. BMP-9, BMP-10, BMP-11, BMP-12, BMP-13, BMP-14, B1VIP-15, and BMP-16. Currently preferred BMP's are BMP-2, BMP-3, BMP-4, BMP-5, BMP-6, BMP-7. These dimeric proteins can be provided as homodimers, heterodimers, or combinations thereof, alone or together with other molecules. Cells can be of human origin (autologous or allogeneic) or from an animal source (xenogeneic), genetically engineered, if desired, to deliver proteins of interest at the transplant site. The delivery media can be formulated as needed to maintain cell function and viability. Cells include whole bone marrow, bone marrow derived mono-nuclear cells, progenitor cells (e.g., endothelial progentitor cells) stem cells (e.g., mesenchymal, hematopoietic, neuronal), pluripotent stem cells, fibroblasts, macrophage, and satellite cells.
_7_ Biologically active material also includes non-genetic therapeutic agents, such as:
~ anti-thrombogenic agents such as heparin, heparin derivatives, urokinase, and PPack (dextrophenylalanine proline arginine chloromethylketone);
~ anti-proliferative agents such as enoxaprin, angiopeptin, or monoclonal antibodies capable of blocking smooth muscle cell proliferation, hirudin, and acetylsalicylic acid, amlodipine and doxazosin;
~ anti-inflammatory agents such as glucocorticoids, betamethasone, dexamethasone, prednisolone, corticosterone, budesonide, estrogen, sulfasalazine, and mesalamine;
~ antineoplastic/antiproliferativelanti-miotic agents such as paclitaxel, 5-fluorouracil, cisplatin, vinblastine, vincristine, epothilones, methotrexate, azathioprine, adriamycin and mutamycin; endostatin, angiostatin and thymidine kinase inhibitors, taxol and its analogs or derivatives;
~ anesthetic agents such as lidocaine, bupivacaine, and ropivacaine;
~ anti-coagulants such as D-Phe-Pro-Arg chloromethyl keton, an RGD
peptide-containing compound, heparin, antithrombin compounds, platelet receptor antagonists, anti-thrombin anticodies, anti-platelet receptor antibodies, aspirin (aspirin is also classified as an analgesic, antipyretic and anti-inflammatory drug), dipyridamole, protainine, hirudin, prostaglandin inhibitors platelet inhibitors and tick antiplatelet peptides;
vascular cell growth promotors such as growth factors, Vascular Endothelial Growth Factors (FEGF, all types including VEGF-2), growth factor receptors, transcriptional activators, and translational promotors;
~ vascular cell growth inhibitors such as antiproliferative agents, growth factor inhibitors, growth factor receptor antagonists, transcriptional repressors, translational repressors, replication inhibitors, inhibitory antibodies, antibodies directed against growth factors, bifunctional molecules consisting of a growth factor and a cytotoxin, bifunctional molecules consisting of an antibody and a cytotoxin;
~ cholesterol-lowering agents; vasodilating agents; and agents which interfere with endogenous vasoactive mechanisms;
~ anti-oxidants, such as probucol;
~ antibiotic agents, such as penicillin, cefoxitin, oxacillin, tobranycin ~ angiogenic substances, such as acidic and basic fibrobrast growth factors, estrogen including estradiol (E2), estriol (E3) and 17-Beta Estradiol; and ~ drugs for heart failure, such as digoxin, beta-blockers, angiotensin-converting enzyme (ACE) inhibitors including captopril and enalopril.
_g_ A biologically active material can be placed into the channel by various methods including injection as explained above. For instance, after the biologically active material is dissolved or suspended in water or an aqueous solution, it can be injected into the channel. Also, the biologically active material can be introduced into a channel by diffusion in the solution. For example, a stmt with an empty channel is dipped in a solution or suspensions of the biologically active material to allow the biologically active material to diffuse into the channel. Also, when the biologically active material is dissolved in an organic solvent, it can be introduced into a channel by diffusion in a vapor of the solvent solution. When the biologically active material is a biological material, such as tissue culture cells, yeast, and bacteria, it can be introduced into a channel by migration or by injection of a culture medium containing the biological material.
Stems suitable for the present invention include any stmt for medical purpose without limitation, which are known to the skilled artisan. Stems suitable for the present invention include vascular stems such as self-expanding stems and balloon expandable stems. Examples of self expanding stems useful in the present invention are illustrated in U.S. Patent Nos. 4,655,771 and 4,954,126 issued to Wallsten and 5,061,275 issued to Wallsten et al. Examples of appropriate balloon-expandable stems are shown in U.S. Patent No. 4,733,665 issued to Palmaz, U.S. Patent No. 4,800,882 issued to Gianturco and U.S. Patent No. 4,886,062 issued to Wiktor. Expandable stmt may be formed from polymeric, metallic and/or ceramic materials. Suitable materials include, without limitation, metals, such as tantalum, stainless steel, nitinol, titanium, and alloys, and polymeric materials, such as poly-L-lactic acid, polycarbonate, and polyethylene terephtalate. Also, stems made with biostable or bioabsorbable polymers such as polyethylene terephthalate), polyacetal, poly(lactic acid), polyethylene oxide)/poly(butylene terephthalate) copolymer could be used in the present invention.
Stent covering materials suitable for the present invention include any covering material for the stmt which are known to the skilled artisan. The covering can be a polymer, which is preferably selected from elastomeric polymers, e.g., silicones, polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, EPDM rubbers, polytetrafluoroethylene (PTFE) or expanded PTFE
(ePTFE).
Suitable thickness of the cover are known in the art and can be selected by artisans. The cover can be produced by any method suitable and known in the art. For example, by dipping a stmt in a polymer, spraying a polymer covering solution onto a stmt, wrapping the stmt with a material or encapsulating the stmt in a polymer tube.
Examples for suitable materials for making the channel, i.e., channel materials, are, without limitation, poly(L-lactic acid), poly(lactic acid-co-glycotic acid), polyether, polyurethane, and silicone. The material for the channel material can be selected to control release of the drug contained in the channel. For example, in the embodiment where the channel is located in the stmt covering, the channel material and covering materials used are selected so that the biologically active material can be released at a certain rate or in a certain manner.
Preferably, the channel has a cylindrical-like shape, where the channel has a circular cross-section as shown in the figures. However, the channel need not be cylindrical. Instead, the channel can have an oblong, square or star-like shaped cross-section, or any other type of shape.
The diameter of the channel of the present invention is not limited and should be selected depending on the type and amount of biologically active material to be deliver, the rate of the delivery, and the method for manufacture. For instance, when the biologically active material is injected into the channel by a syringe rather than by diffusion, migration or by inserting a mandrel containing the biologically active material, the channel diameter should be large enough to allow such injection. When the biologically active material is placed into the channel by migration, the channel should have opening(s), i.e., an open end or pores) which are large enough for such migration of the biologically active material into and out of the channel space. Alternatively, the biological material can be trapped in the channel and prevented from migration but allowed to produce a biological active material that can actively regulate biological function. For example, growth-factor producing cells are trapped in the channel, but the growth factor that these cells produce is gradually released from the channel while the cells stay in the channel.
Moreover, the ~5 present invention may include not only macro channels but also micro channels. The micro channels may be produced by micro-fabrication, by printing a pattern on the stmt or stmt cover, or using pre-printed sheets. The macro channels maybe preferable because of their larger capacity for containing biologically active material.
The suitable diameter of the channel depends on various factors, such as the 30 material to be used to make the channel, the manner to inject the biologically active material, the thickness of the material, the size and type of the stmt, the configuration of the channel, method of manufacture, amount of the biologically active material to be deliver and the rate of the delivery. The inner diameter of the channel is normally from about 10 ~Cm to about 1 mm, preferably from about 50 ~,m to about 500 ~.m.
The thickness of the channel wall is not limited and depends on the biologically active material to be deliver, the rate of the delivery, method for manufacture, and type of channel material used. For example, when the channel material is polyethylene terephthalate), the thickness is generally between 10 p,m and 2000 ~,m, preferably between 50 p,m and 600 p,m, more preferably 50 ~m and 450 ~Cm.
The release rate of the biologically active material depends on the degree of porosity of the channel material and covering material, hydrophobicity of the channel material and covering material, the thickness of the channel wall and covering, and the biologically active material's chemical and physical features. Thus, by selecting an appropriate covering material, channel material and a thickness of the covering and/or channel wall, the release rate of a biologically active material can be controlled.
Additionally, a further control can be possible by using wide variety of pharmaceutical forms of the drugs and Garners, such as bars, particles, gels, and fluids.
The release rate of the biologically active material is not necessarily uniform.
For example, by selecting a porous material for inner covering of stmt and a less porous material for the outer covering, the release rate of the biologically active material at the interior luminal surface of the stmt is greater than at the stmt's exterior surface.
Accordingly, there can be a lag time between the implantation of the stmt and the biologically active material is first released. Alternatively, there can be a gradient for a biologically active material contained in the channel. If the concentration of the biologically active material is high in the center of the channel and becomes lower at points further from the center, the release rate can increase with time. If the concentration of the biologically active material is low in the center of the channel and becomes higher as distant from the center, the releasing rate can gradually decrease with time.
In some embodiments, the channel wall has a plurality of ports which allow a biologically active material to pass through. The biologically active material, such as tissue culture cells, yeast, bacteria can migrate through the ports. Such channel may be substantially covered with a covering.
A stmt of the present invention can be implanted into a body lumen using any conventional method known in the art. The body lumen into which the stmt can be implanted includes blood vessels, urinary tract, coronary vasculature, esophagus, trachea, colon, and biliary tract. Once the stmt with the channels) is placed in a body lumen, the biologically active material in the channel can be released from the channel by diffusion through the channel wall. In another embodiment of the present invention, a biologically active material is released from the channel by application of pressure. For example, the stmt is inserted into a body lumen by a balloon catheter and the biologically active material is squeezed out from the channel when the stmt is pressed onto the body lumen surface by expanding balloon.
The description contained herein is for purposes of illustration and not for purposes of limitation. Changes and modifications may be made to the embodiments of the description and still be within the scope of the invention. Furthermore, obvious changes, modifications or variations will occur to those skilled in the art. Also, all references cited above are incorporated herein, in their entirety, for all purposes related to this disclosure.
Claims (57)
We claim:
1. An implantable stent prosthesis for delivery of a biologically active material to a body lumen of a patient, wherein the stent comprises a sidewall and at least one channel for containing the biologically active material, wherein the sidewall comprises at least in part a plurality of struts having an exterior surface, and the channel comprises a channel wall defining a channel space.
2. The stent of claim 1, wherein the stent sidewall has an interior luminal surface and an opposed exterior surface extending along a longitudinal stent axis;
and wherein the stent further comprises a stent covering made of a covering material disposed over at least the interior luminal surface or the exterior surface of the stent sidewall.
and wherein the stent further comprises a stent covering made of a covering material disposed over at least the interior luminal surface or the exterior surface of the stent sidewall.
3. The stent of claim 2, wherein the channel is positioned within the covering.
4. The stent of claim 3, wherein the channel is positioned entirely within the covering.
5. The stent of claim 3, wherein the stent sidewall comprises at least in part a plurality of struts, and wherein the channel wall comprises in part a portion of the exterior surface of a strut.
6. The stent of claim 3, wherein the covering is disposed over the exterior surface of the stent sidewall.
7. The stent of claim 3, wherein the covering is disposed over the interior luminal surface of the stent sidewall.
8. The stent of claim 3, wherein the covering is comprised of two or more layers of covering material and wherein the channel is positioned between two layers.
9. The stent of claim 2, wherein the covering material is selected from the group consisting of silicones, polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, EPDM rubbers, polytetrafluoroethylene and expanded polytetrafluoroethylene.
10. The stent of claim 2, wherein the channel wall is comprised of at lease one layer of a channel material and wherein the channel is positioned within the covering.
11. The stent of claim 10, wherein the channel material allows controlled release of the biologically active material.
12. The stent of claim 10, wherein the channel material is selected from the group consisting of poly(L-lactic acid), poly(lactic acid-co-glycotic acid), polyether, polyurethane, and silicone.
13. The stent of claim 1, wherein the .stent sidewall is formed at least in part by the channel, and wherein the channel wall is comprised of at least one layer of a channel material.
14. The stent of claim 13, wherein at least one of the struts is fused to the channel wall.
15. The stent of claim 13, wherein at least one of the struts is woven with the channel.
16. The stent of claim 13, wherein the struts and channel are covered with a covering material.
17. The stent of claim 13, wherein the channel material is selected from the group consisting of poly(L-lactic acid), poly(lactic acid-co-glycotic acid), polyether, polyurethane, and silicone.
18. The stent of claim 1, wherein the channel is positioned parallel to a longitudinal axis of the stent.
19. The stent of claim 1, wherein the channel is positioned along a circumference of the stent.
20. The stent of claim 1, wherein the channel has a cylindrical-like shape.
21. The scent of claim 1, wherein the channel has an oblong-shaped cross section.
22. The stent of claim 1, wherein the channel has a square-shaped cross section.
23. The stent of claim 1, wherein the channel has a star-shaped cross section.
24. The stent of claim 1, wherein the inner diameter of the channel is between about 10 µm and about 1 µm.
25. The stent of claim 24, wherein the inner diameter of the channel is between about 50 µm and about 500 µm.
26. The stent of claim 1, wherein the channel has at least one opened end.
27. The stent of claim 26, wherein a tube having an end, is positioned in the channel, and wherein the end of the tube protrudes from the opened end of the channel.
28. A method for making an implantable stent prosthesis having a sidewall and at least one channel for containing a biologically active material, wherein the sidewall comprises at least in part a plurality of struts having an exterior surface and the channel comprises a channel wall defining a channel space, the method comprises the steps of:
(a) obtaining the stent covered by a layer of a stent covering material;
(b) placing at least one tube or mandrel in contact with the covering material, (c) surrounding the tube or mandrel with the covering material, and (d) forming the channel so that it is located within the covering material and wherein the channel has two open ends.
(a) obtaining the stent covered by a layer of a stent covering material;
(b) placing at least one tube or mandrel in contact with the covering material, (c) surrounding the tube or mandrel with the covering material, and (d) forming the channel so that it is located within the covering material and wherein the channel has two open ends.
29. The method of claim 28, wherein the channel is formed by exposing the covering material to a treatment selected from the group consisting of heat treatment, chemical treatment or treatment with an adhesive.
30. The method of claim 28, wherein the channel is located entirely within the covering material.
31. The method of claim 28, which further comprises sealing one of the open ends of the channel by exposing the end to a treatment selected from the group consisting of heat treatment, chemical treatment or treatment with an adhesive.
32. The method of claim 28, which further comprises the steps of:
(e) removing the tube or mandrel from the channel; and (f) introducing a biologically active material into the channel
(e) removing the tube or mandrel from the channel; and (f) introducing a biologically active material into the channel
33. The method of claim 32, which further comprises the step of sealing at least open end of the channel by exposing the end to a treatment selected from the group consisting of heat treatment, chemical treatment or treatment with an adhesive.
34. The method of claim 32, wherein the tube is hollow and is placed in contact with the covering material in a matter such that an end of the tube protrudes from one of the open ends of the channel, and the biologically active material is introduced into the channel by injection of the biologically active material into the protruding end of the hollow tube.
35. The method of claim 32, wherein the biologically active material is introduced into the channel by diffusion of the biologically active material.
36. The method of claim 29, wherein the biologically active material is introduced into the channel by migration of the biologically active material.
37. The method of claim 28, which further comprises covering the tube or mandrel with a channel material before placing the tube or mandrel in contact with the covering material.
38. The method of claim 28 wherein the covering material is selected from the group consisting of silicones, polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, EPDM rubbers, polytetrafluoroethylene and expanded polytetrafluoroethylene.
39. The method of claim 28, wherein the mandrel is comprised of a biologically active material.
40. A method for making an implantable stent prosthesis having a sidewall comprised of a plurality of struts and at least one channel comprising a channel wall defining a channel space for containing a biologically active material, the method comprises the steps of:
(a) covering a tube or mandrel with a channel material;
(b) forming the channel, having two open ends, by exposing the covered tube or mandrel to a treatment selected from the group consisting of heat treatment, chemical treatment or treatment with an adhesive; and (c) attaching the channel to the sidewall.
(a) covering a tube or mandrel with a channel material;
(b) forming the channel, having two open ends, by exposing the covered tube or mandrel to a treatment selected from the group consisting of heat treatment, chemical treatment or treatment with an adhesive; and (c) attaching the channel to the sidewall.
41. The method of claim 40 wherein the channel is attached to the sidewall by attaching the channel to a strut.
42. The method of claim 41 wherein the channel is attached to the strut by fusing the channel to the strut.
43. The method of claim 41 wherein the channel is attached to the sidewall by weaving the channel with a strut.
44. The method of claim 41 which further comprises covering the channel and strut with a covering material
45. The method of claim 40 which further comprises removing the tube or mandrel and introducing the biologically active material into the channel.
46. The method of claim 45, wherein the tube or mandrel is removed before the channel is attached to the sidewall.
47. The method of claim 45 wherein the biologically active material is introduced into the channel before the channel is attached to the sidewall.
48. The method of claim 45 wherein the biologically active material is introduced into the channel using a technique selected from the group consisting of injecting the biologically active material into the channel, allowing the biologically active material to diffuse into the channel and allowing the biologically active material to migrate into the channel.
49. The method of claim 40 wherein the channel material is selected from the group consisting of poly(L-lactic acid), poly(lactic acid-co-glycotic acid), polyether, polyurethane, and silicone.
50. A method for making an implantable stent prosthesis having a sidewall comprised of (1) a plurality of struts formed from a strut material and (2) at least one channel comprising a channel wall defining a channel space for containing a biologically active material, the method comprises the steps of:
(a) covering a tube or mandrel with a channel material;
(b) forming the channel by exposing the covered tube or mandrel to a treatment selected from the group consisting of heat treatment, chemical treatment or treatment with an adhesive;
(c) attaching the channel to strut material to form a stent wire; and (d) weaving the stent wire to form the sidewall of the stent.
(a) covering a tube or mandrel with a channel material;
(b) forming the channel by exposing the covered tube or mandrel to a treatment selected from the group consisting of heat treatment, chemical treatment or treatment with an adhesive;
(c) attaching the channel to strut material to form a stent wire; and (d) weaving the stent wire to form the sidewall of the stent.
51. The method of claim 50 wherein the stent wire is covered with a covering material.
52. The method of claim 51 wherein the covering material is selected from the group consisting of silicones, polyurethanes, thermoplastic elastomers, ethylene vinyl acetate copolymers, polyolefin elastomers, EPDM rubbers, polytetrafluoroethylene and expanded polytetrafluoroethylene.
50. The method of claim 51 wherein the stent wire is covered with the covering material before the stent wire is woven.
54. A method of treating an afflicted area of a surface of a body lumen comprising:
(a) implanting into the body lumen a stent prosthesis having a sidewall comprising in part a plurality of struts having an exterior surface and at least one channel comprising a channel wall defining a channel space containing a biologically active material;
(b) delivering the biologically active material to the afflicted area.
(a) implanting into the body lumen a stent prosthesis having a sidewall comprising in part a plurality of struts having an exterior surface and at least one channel comprising a channel wall defining a channel space containing a biologically active material;
(b) delivering the biologically active material to the afflicted area.
55. The method of claim 54 wherein the biologically active material is delivered by squeezing the biologically active material out of the channel.
56. The method of claim 54 wherein the biologically active material is delivered by allowing the biologically active material to diffuse out of the channel.
57. The method of claim 54 wherein the biologically active material is delivered by allowing the biologically active material to migrate out of the channel.
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US09/774,218 | 2001-01-30 | ||
US09/774,218 US6752829B2 (en) | 2001-01-30 | 2001-01-30 | Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same |
PCT/US2002/002635 WO2002060351A1 (en) | 2001-01-30 | 2002-01-30 | Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same |
Publications (1)
Publication Number | Publication Date |
---|---|
CA2436241A1 true CA2436241A1 (en) | 2002-08-08 |
Family
ID=25100582
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
CA002436241A Abandoned CA2436241A1 (en) | 2001-01-30 | 2002-01-30 | Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same |
Country Status (7)
Country | Link |
---|---|
US (3) | US6752829B2 (en) |
EP (1) | EP1355589B1 (en) |
JP (1) | JP4271938B2 (en) |
AU (1) | AU2002237975B2 (en) |
CA (1) | CA2436241A1 (en) |
DE (2) | DE02704283T1 (en) |
WO (1) | WO2002060351A1 (en) |
Cited By (27)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7931683B2 (en) | 2007-07-27 | 2011-04-26 | Boston Scientific Scimed, Inc. | Articles having ceramic coated surfaces |
US7938855B2 (en) | 2007-11-02 | 2011-05-10 | Boston Scientific Scimed, Inc. | Deformable underlayer for stent |
US7942926B2 (en) | 2007-07-11 | 2011-05-17 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
US7976915B2 (en) | 2007-05-23 | 2011-07-12 | Boston Scientific Scimed, Inc. | Endoprosthesis with select ceramic morphology |
US7981150B2 (en) | 2006-11-09 | 2011-07-19 | Boston Scientific Scimed, Inc. | Endoprosthesis with coatings |
US8002823B2 (en) | 2007-07-11 | 2011-08-23 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
US8029554B2 (en) | 2007-11-02 | 2011-10-04 | Boston Scientific Scimed, Inc. | Stent with embedded material |
US8066763B2 (en) | 1998-04-11 | 2011-11-29 | Boston Scientific Scimed, Inc. | Drug-releasing stent with ceramic-containing layer |
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 |
US8071156B2 (en) | 2009-03-04 | 2011-12-06 | Boston Scientific Scimed, Inc. | Endoprostheses |
US8070797B2 (en) | 2007-03-01 | 2011-12-06 | Boston Scientific Scimed, Inc. | Medical device with a porous surface for delivery of a therapeutic agent |
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 |
US8216632B2 (en) | 2007-11-02 | 2012-07-10 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
US8221822B2 (en) | 2007-07-31 | 2012-07-17 | Boston Scientific Scimed, Inc. | Medical device coating by laser cladding |
US8231980B2 (en) | 2008-12-03 | 2012-07-31 | Boston Scientific Scimed, Inc. | Medical implants including iridium oxide |
US8287937B2 (en) | 2009-04-24 | 2012-10-16 | Boston Scientific Scimed, Inc. | Endoprosthese |
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 |
US8815275B2 (en) | 2006-06-28 | 2014-08-26 | Boston Scientific Scimed, Inc. | Coatings for medical devices comprising a therapeutic agent and a metallic material |
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 |
US9284409B2 (en) | 2007-07-19 | 2016-03-15 | Boston Scientific Scimed, Inc. | Endoprosthesis having a non-fouling surface |
Families Citing this family (177)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
AU716005B2 (en) | 1995-06-07 | 2000-02-17 | Cook Medical Technologies Llc | Implantable medical device |
US7341598B2 (en) | 1999-01-13 | 2008-03-11 | Boston Scientific Scimed, Inc. | Stent with protruding branch portion for bifurcated vessels |
US6890546B2 (en) | 1998-09-24 | 2005-05-10 | Abbott Laboratories | Medical devices containing rapamycin analogs |
US20030129215A1 (en) * | 1998-09-24 | 2003-07-10 | T-Ram, Inc. | Medical devices containing rapamycin analogs |
US7208010B2 (en) | 2000-10-16 | 2007-04-24 | Conor Medsystems, Inc. | Expandable medical device for delivery of beneficial agent |
US20040254635A1 (en) * | 1998-03-30 | 2004-12-16 | Shanley John F. | Expandable medical device for delivery of beneficial agent |
US7179289B2 (en) * | 1998-03-30 | 2007-02-20 | Conor Medsystems, Inc. | Expandable medical device for delivery of beneficial agent |
US7208011B2 (en) * | 2001-08-20 | 2007-04-24 | Conor Medsystems, Inc. | Implantable medical device with drug filled holes |
US20160287708A9 (en) * | 2000-03-15 | 2016-10-06 | Orbusneich Medical, Inc. | Progenitor Endothelial Cell Capturing with a Drug Eluting Implantable Medical Device |
US9522217B2 (en) | 2000-03-15 | 2016-12-20 | Orbusneich Medical, Inc. | Medical device with coating for capturing genetically-altered cells and methods for using same |
US8088060B2 (en) | 2000-03-15 | 2012-01-03 | Orbusneich Medical, Inc. | Progenitor endothelial cell capturing with a drug eluting implantable medical device |
US20050271701A1 (en) * | 2000-03-15 | 2005-12-08 | Orbus Medical Technologies, Inc. | Progenitor endothelial cell capturing with a drug eluting implantable medical device |
US7419678B2 (en) * | 2000-05-12 | 2008-09-02 | Cordis Corporation | Coated medical devices for the prevention and treatment of vascular disease |
AU9463401A (en) * | 2000-10-16 | 2002-04-29 | Conor Medsystems Inc | Expandable medical device for delivery of beneficial agent |
US6752829B2 (en) * | 2001-01-30 | 2004-06-22 | Scimed Life Systems, Inc. | Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same |
US20040204756A1 (en) * | 2004-02-11 | 2004-10-14 | Diaz Stephen Hunter | Absorbent article with improved liquid acquisition capacity |
US20040073294A1 (en) * | 2002-09-20 | 2004-04-15 | Conor Medsystems, Inc. | Method and apparatus for loading a beneficial agent into an expandable medical device |
US20040220660A1 (en) * | 2001-02-05 | 2004-11-04 | Shanley John F. | Bioresorbable stent with beneficial agent reservoirs |
CA2435306C (en) | 2001-02-16 | 2010-12-21 | Stephan Wnendt | Implants with fk506 |
NL1017672C2 (en) * | 2001-03-22 | 2002-09-24 | Hendrik Glastra | Implantable assembly with therapeutic effect. |
US7727221B2 (en) | 2001-06-27 | 2010-06-01 | Cardiac Pacemakers Inc. | Method and device for electrochemical formation of therapeutic species in vivo |
US7842083B2 (en) | 2001-08-20 | 2010-11-30 | Innovational Holdings, Llc. | Expandable medical device with improved spatial distribution |
US7445629B2 (en) * | 2002-01-31 | 2008-11-04 | Boston Scientific Scimed, Inc. | Medical device for delivering biologically active material |
US7326245B2 (en) * | 2002-01-31 | 2008-02-05 | Boston Scientific Scimed, Inc. | Medical device for delivering biologically active material |
US7122048B2 (en) * | 2002-05-03 | 2006-10-17 | Scimed Life Systems, Inc. | Hypotube endoluminal device |
AU2003250913A1 (en) * | 2002-07-08 | 2004-01-23 | Abbott Laboratories Vascular Enterprises Limited | Drug eluting stent and methods of manufacture |
US20040034407A1 (en) * | 2002-08-16 | 2004-02-19 | John Sherry | Covered stents with degradable barbs |
JP5445649B2 (en) * | 2002-08-23 | 2014-03-19 | 独立行政法人国立循環器病研究センター | Stent |
JP5463513B2 (en) * | 2002-08-23 | 2014-04-09 | 株式会社日本ステントテクノロジー | Stent |
EP1550477B1 (en) * | 2002-08-23 | 2015-11-04 | National Cerebral and Cardiovascular Center | Stent and process for producing the same |
US8246673B2 (en) * | 2002-09-19 | 2012-08-21 | Exstent Limited | External support for a blood vessel |
US20060129228A1 (en) * | 2002-09-19 | 2006-06-15 | Golesworthy Taliesin J | Stents |
US7758636B2 (en) * | 2002-09-20 | 2010-07-20 | Innovational Holdings Llc | Expandable medical device with openings for delivery of multiple beneficial agents |
EP2668933A1 (en) * | 2002-09-20 | 2013-12-04 | Innovational Holdings, LLC | Expandable medical device with openings for delivery of multiple beneficial agents |
US20040093056A1 (en) | 2002-10-26 | 2004-05-13 | Johnson Lianw M. | Medical appliance delivery apparatus and method of use |
US7875068B2 (en) | 2002-11-05 | 2011-01-25 | Merit Medical Systems, Inc. | Removable biliary stent |
US7637942B2 (en) | 2002-11-05 | 2009-12-29 | Merit Medical Systems, Inc. | Coated stent with geometry determinated functionality and method of making the same |
US7959671B2 (en) | 2002-11-05 | 2011-06-14 | Merit Medical Systems, Inc. | Differential covering and coating methods |
US6926735B2 (en) * | 2002-12-23 | 2005-08-09 | Scimed Life Systems, Inc. | Multi-lumen vascular grafts having improved self-sealing properties |
AU2004226327A1 (en) * | 2003-03-28 | 2004-10-14 | Innovational Holdings, Llc | Implantable medical device with beneficial agent concentration gradient |
US20050010170A1 (en) * | 2004-02-11 | 2005-01-13 | Shanley John F | Implantable medical device with beneficial agent concentration gradient |
US7637934B2 (en) | 2003-03-31 | 2009-12-29 | Merit Medical Systems, Inc. | Medical appliance optical delivery and deployment apparatus and method |
US7344559B2 (en) * | 2003-08-25 | 2008-03-18 | Biophan Technologies, Inc. | Electromagnetic radiation transparent device and method of making thereof |
US7785653B2 (en) | 2003-09-22 | 2010-08-31 | Innovational Holdings Llc | Method and apparatus for loading a beneficial agent into an expandable medical device |
US20050075713A1 (en) * | 2003-10-06 | 2005-04-07 | Brian Biancucci | Minimally invasive valve replacement system |
US8435285B2 (en) * | 2003-11-25 | 2013-05-07 | Boston Scientific Scimed, Inc. | Composite stent with inner and outer stent elements and method of using the same |
US20050113904A1 (en) * | 2003-11-25 | 2005-05-26 | Shank Peter J. | Composite stent with inner and outer stent elements and method of using the same |
EP1699527A1 (en) | 2004-01-02 | 2006-09-13 | Advanced Cardiovascular Systems, Inc. | High-density lipoprotein coated medical devices |
US7803178B2 (en) | 2004-01-30 | 2010-09-28 | Trivascular, Inc. | Inflatable porous implants and methods for drug delivery |
CA2556212C (en) * | 2004-02-13 | 2013-05-28 | Conor Medsystems, Inc. | Implantable drug delivery device including wire filaments |
US8349001B2 (en) * | 2004-04-07 | 2013-01-08 | Medtronic, Inc. | Pharmacological delivery implement for use with cardiac repair devices |
CA2559540A1 (en) | 2004-06-08 | 2005-12-29 | Advanced Stent Technologies, Inc. | Stent with protruding branch portion for bifurcated vessels |
EP2111881A1 (en) | 2004-07-05 | 2009-10-28 | Ziscoat N.V. | Biocompatible coating of medical devices comprising molecular sieves |
US7601382B2 (en) * | 2004-08-05 | 2009-10-13 | Boston Scientific Scimed, Inc. | Method of making a coated medical device |
US20060125144A1 (en) * | 2004-12-14 | 2006-06-15 | Jan Weber | Stent and stent manufacturing methods |
EP1903999B1 (en) | 2005-04-25 | 2018-11-21 | Covidien LP | Controlled fracture connections for stents |
US8002730B2 (en) | 2005-04-29 | 2011-08-23 | Medtronic, Inc. | Anti-thrombogenic venous shunt system and method |
US7963988B2 (en) * | 2005-06-23 | 2011-06-21 | Boston Scientific Scimed, Inc. | ePTFE lamination—resizing ePTFE tubing |
US7658880B2 (en) * | 2005-07-29 | 2010-02-09 | Advanced Cardiovascular Systems, Inc. | Polymeric stent polishing method and apparatus |
US20070043423A1 (en) * | 2005-08-10 | 2007-02-22 | Med Institute Inc. | Intraluminal device with a hollow structure |
US20070055352A1 (en) * | 2005-09-07 | 2007-03-08 | Wendy Naimark | Stent with pockets for containing a therapeutic agent |
US20070112421A1 (en) * | 2005-11-14 | 2007-05-17 | O'brien Barry | Medical device with a grooved surface |
US20070196423A1 (en) * | 2005-11-21 | 2007-08-23 | Med Institute, Inc. | Implantable medical device coatings with biodegradable elastomer and releasable therapeutic agent |
US9446226B2 (en) * | 2005-12-07 | 2016-09-20 | Ramot At Tel-Aviv University Ltd. | Drug-delivering composite structures |
US7540881B2 (en) | 2005-12-22 | 2009-06-02 | Boston Scientific Scimed, Inc. | Bifurcation stent pattern |
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 |
US20070203564A1 (en) * | 2006-02-28 | 2007-08-30 | Boston Scientific Scimed, Inc. | Biodegradable implants having accelerated biodegradation properties in vivo |
US8003388B2 (en) * | 2006-03-24 | 2011-08-23 | Nortis, Inc. | Method for creating perfusable microvessel systems |
US8445280B2 (en) * | 2006-03-24 | 2013-05-21 | Nortis, Inc. | Method for creating perfusable microvessel systems |
US7622298B2 (en) * | 2006-03-24 | 2009-11-24 | Norits, Inc. | Method for creating perfusable microvessel systems |
US8048150B2 (en) | 2006-04-12 | 2011-11-01 | Boston Scientific Scimed, Inc. | Endoprosthesis having a fiber meshwork disposed thereon |
US20080082036A1 (en) * | 2006-04-25 | 2008-04-03 | Medtronic, Inc. | Cerebrospinal fluid shunt having long term anti-occlusion agent delivery |
US9101505B2 (en) * | 2006-04-27 | 2015-08-11 | Brs Holdings, Llc | Composite stent |
US9155646B2 (en) * | 2006-04-27 | 2015-10-13 | Brs Holdings, Llc | Composite stent with bioremovable ceramic flakes |
US20080051335A1 (en) * | 2006-05-02 | 2008-02-28 | Kleiner Lothar W | Methods, compositions and devices for treating lesioned sites using bioabsorbable carriers |
EP2020956A2 (en) | 2006-05-26 | 2009-02-11 | Nanyang Technological University | Implantable article, method of forming same and method for reducing thrombogenicity |
DE112007001360B4 (en) * | 2006-06-05 | 2013-04-18 | Visicon Inspection Technologies Llc | Stent Inspection System |
US8603530B2 (en) | 2006-06-14 | 2013-12-10 | Abbott Cardiovascular Systems Inc. | Nanoshell therapy |
WO2008013803A2 (en) * | 2006-07-24 | 2008-01-31 | Massachusetts Institute Of Technology | Endovascular devices with axial perturbations |
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 |
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 |
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 |
DE602007011114D1 (en) | 2006-09-15 | 2011-01-20 | Boston Scient Scimed Inc | BIODEGRADABLE ENDOPROTHESIS WITH BIOSTABILES INORGANIC LAYERS |
WO2008036548A2 (en) | 2006-09-18 | 2008-03-27 | Boston Scientific Limited | Endoprostheses |
US7951191B2 (en) | 2006-10-10 | 2011-05-31 | Boston Scientific Scimed, Inc. | Bifurcated stent with entire circumferential petal |
DE602007011822D1 (en) * | 2006-11-16 | 2011-02-17 | Boston Scient Ltd | STENT WITH FUNCTION FOR DIFFERENT TIMES OF ABLUMINAL AND LUMINOUS RELEASE OF A TREATMENT |
US7842082B2 (en) | 2006-11-16 | 2010-11-30 | Boston Scientific Scimed, Inc. | Bifurcated stent |
US20080152784A1 (en) * | 2006-12-22 | 2008-06-26 | Boston Scientific Scimed, Inc. | Methods of manufacturing coatings and coated medical devices |
ES2506144T3 (en) | 2006-12-28 | 2014-10-13 | Boston Scientific Limited | Bioerodible endoprosthesis and their manufacturing procedure |
WO2008095052A2 (en) | 2007-01-30 | 2008-08-07 | Loma Vista Medical, Inc., | Biological navigation device |
EP2120807A2 (en) * | 2007-02-13 | 2009-11-25 | Cinvention Ag | Degradable reservoir implants |
US20080234809A1 (en) * | 2007-03-23 | 2008-09-25 | Medtronic Vascular, Inc. | Stent Graft System With Injection Tube |
US20080275543A1 (en) * | 2007-05-02 | 2008-11-06 | Boston Scientific Scimed, Inc. | Stent |
US8328867B2 (en) | 2007-06-08 | 2012-12-11 | Medtronic Vascular, Inc. | Drug loaded implantable medical device |
US9358037B2 (en) | 2007-06-26 | 2016-06-07 | Roxwood Medical, Inc. | Method and apparatus for centering a microcatheter within a vasculature |
US9125683B2 (en) | 2007-06-26 | 2015-09-08 | Roxwood Medical Inc. | Method and apparatus for placing a catheter within a vasculature |
ES2547490T3 (en) | 2007-06-26 | 2015-10-06 | Roxwood Medical, Inc. | Catheter apparatus and procedures to treat blood vessels |
US9126020B2 (en) | 2007-06-26 | 2015-09-08 | Roxwood Medical, Inc. | Catheter apparatus with telescoping lumen catheters and its use in methods for treating vasculatures |
US20090030504A1 (en) * | 2007-07-27 | 2009-01-29 | Boston Scientific Scimed, Inc. | Medical devices comprising porous inorganic fibers for the release of therapeutic agents |
US7959669B2 (en) | 2007-09-12 | 2011-06-14 | Boston Scientific Scimed, Inc. | Bifurcated stent with open ended side branch support |
US8052745B2 (en) | 2007-09-13 | 2011-11-08 | Boston Scientific Scimed, Inc. | Endoprosthesis |
US20090076591A1 (en) * | 2007-09-19 | 2009-03-19 | Boston Scientific Scimed, Inc. | Stent Design Allowing Extended Release of Drug and/or Enhanced Adhesion of Polymer to OD Surface |
US8663309B2 (en) | 2007-09-26 | 2014-03-04 | Trivascular, Inc. | Asymmetric stent apparatus and method |
US8226701B2 (en) | 2007-09-26 | 2012-07-24 | Trivascular, Inc. | Stent and delivery system for deployment thereof |
US8066755B2 (en) | 2007-09-26 | 2011-11-29 | Trivascular, Inc. | System and method of pivoted stent deployment |
US20090093871A1 (en) * | 2007-10-08 | 2009-04-09 | Medtronic Vascular, Inc. | Medical Implant With Internal Drug Delivery System |
EP3135247B1 (en) * | 2007-10-11 | 2023-07-26 | Implantica Patent Ltd. | Implantable tissue connector |
EP3025676B1 (en) * | 2007-10-11 | 2019-12-25 | Implantica Patent Ltd. | Implantable tissue connector |
US8083789B2 (en) | 2007-11-16 | 2011-12-27 | Trivascular, Inc. | Securement assembly and method for expandable endovascular device |
US8328861B2 (en) | 2007-11-16 | 2012-12-11 | Trivascular, Inc. | Delivery system and method for bifurcated graft |
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 |
JP5560200B2 (en) * | 2007-12-11 | 2014-07-23 | マサチューセッツ インスチテュート オブ テクノロジー | Implantable drug delivery device for treating bladder and other body vesicles or lumens |
US20090187254A1 (en) * | 2007-12-19 | 2009-07-23 | Boston Scientific Scimed, Inc. | Urological medical devices for release of urologically beneficial agents |
US8277501B2 (en) | 2007-12-21 | 2012-10-02 | Boston Scientific Scimed, Inc. | Bi-stable bifurcated stent petal geometry |
US8070720B2 (en) * | 2008-01-11 | 2011-12-06 | Medtronic Vascular, Inc | Methods for incorporating a drug into an elastomeric medical device |
US20110106120A1 (en) * | 2008-01-18 | 2011-05-05 | Med Institute, Inc. | Intravascular device attachment system having tubular expandable body |
ES2371380T3 (en) * | 2008-01-24 | 2011-12-30 | Boston Scientific Scimed, Inc. | STENT TO SUPPLY A THERAPEUTIC AGENT FROM A SIDE SURFACE OF A STENT STEM. |
US20090198321A1 (en) * | 2008-02-01 | 2009-08-06 | Boston Scientific Scimed, Inc. | Drug-Coated Medical Devices for Differential Drug Release |
US7998192B2 (en) | 2008-05-09 | 2011-08-16 | Boston Scientific Scimed, Inc. | Endoprostheses |
US8932340B2 (en) | 2008-05-29 | 2015-01-13 | Boston Scientific Scimed, Inc. | Bifurcated stent and delivery system |
EP2644225B1 (en) * | 2008-06-02 | 2020-12-23 | Loma Vista Medical, Inc. | Inflatable medical devices |
US8236046B2 (en) | 2008-06-10 | 2012-08-07 | Boston Scientific Scimed, Inc. | Bioerodible endoprosthesis |
US11207199B2 (en) | 2008-06-11 | 2021-12-28 | Q3 Medical Devices Limited | Stent with anti-migration devices |
US10022164B2 (en) | 2008-06-11 | 2018-07-17 | Eventions, Llc | Orthopedic fastener device |
US10245165B2 (en) | 2009-04-02 | 2019-04-02 | Q3 Medical Devices Limited | Stent |
US10117760B2 (en) | 2009-04-02 | 2018-11-06 | Q3 Medical Devices Limited | Stent |
US20100256731A1 (en) | 2009-04-02 | 2010-10-07 | Mangiardi Eric K | Stent |
US10898620B2 (en) | 2008-06-20 | 2021-01-26 | Razmodics Llc | Composite stent having multi-axial flexibility and method of manufacture thereof |
US8206635B2 (en) | 2008-06-20 | 2012-06-26 | Amaranth Medical Pte. | Stent fabrication via tubular casting processes |
US8206636B2 (en) | 2008-06-20 | 2012-06-26 | Amaranth Medical Pte. | Stent fabrication via tubular casting processes |
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 |
WO2010014703A2 (en) * | 2008-07-31 | 2010-02-04 | Boston Scientific Scimed, Inc. | Medical articles comprising biodegradable block copolymers |
US8642063B2 (en) | 2008-08-22 | 2014-02-04 | Cook Medical Technologies Llc | Implantable medical device coatings with biodegradable elastomer and releasable taxane agent |
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 |
CN102341062B (en) * | 2009-01-23 | 2016-05-04 | 安多拉米诺科学公司 | Endovascular device and related system and method |
EP2403546A2 (en) | 2009-03-02 | 2012-01-11 | Boston Scientific Scimed, Inc. | Self-buffering medical implants |
EA023156B1 (en) | 2009-06-26 | 2016-04-29 | ТАРИС Биомедикал ЛЛК | Drug delivery device |
US9283305B2 (en) | 2009-07-09 | 2016-03-15 | Medtronic Vascular, Inc. | Hollow tubular drug eluting medical devices |
US9017312B2 (en) | 2009-09-10 | 2015-04-28 | Taris Biomedical Llc | Implantable device for controlled drug delivery |
EP2477558B1 (en) | 2009-09-14 | 2016-08-10 | CircuLite, Inc. | Endovascular anastomotic connector device and delivery system |
US8828474B2 (en) | 2009-09-20 | 2014-09-09 | Medtronic Vascular, Inc. | Apparatus and methods for loading a drug eluting medical device |
US8678046B2 (en) | 2009-09-20 | 2014-03-25 | Medtronic Vascular, Inc. | Apparatus and methods for loading a drug eluting medical device |
US20110070358A1 (en) * | 2009-09-20 | 2011-03-24 | Medtronic Vascular, Inc. | Method of forming hollow tubular drug eluting medical devices |
US8381774B2 (en) * | 2009-09-20 | 2013-02-26 | Medtronic Vascular, Inc. | Methods for loading a drug eluting medical device |
US8333727B2 (en) * | 2009-10-08 | 2012-12-18 | Circulite, Inc. | Two piece endovascular anastomotic connector |
US8474120B2 (en) * | 2009-10-09 | 2013-07-02 | W. L. Gore & Associates, Inc. | Bifurcated highly conformable medical device branch access |
US9750866B2 (en) | 2010-02-11 | 2017-09-05 | Circulite, Inc. | Cannula lined with tissue in-growth material |
EP2533824B1 (en) | 2010-02-11 | 2019-01-02 | CircuLite, Inc. | Devices for establishing supplemental blood flow in the circulatory system |
US8668732B2 (en) | 2010-03-23 | 2014-03-11 | Boston Scientific Scimed, Inc. | Surface treated bioerodible metal endoprostheses |
US9615948B2 (en) * | 2010-04-26 | 2017-04-11 | Medtronic Vascular, Inc. | Drug eluting folded stent and stent delivery system |
EP2593171B1 (en) | 2010-07-13 | 2019-08-28 | Loma Vista Medical, Inc. | Inflatable medical devices |
US20120059337A1 (en) * | 2010-09-01 | 2012-03-08 | Eran Eilat | Catheter with asymmetric or collapsible-expandable cross-section |
US8333801B2 (en) | 2010-09-17 | 2012-12-18 | Medtronic Vascular, Inc. | Method of Forming a Drug-Eluting Medical Device |
US8632846B2 (en) | 2010-09-17 | 2014-01-21 | Medtronic Vascular, Inc. | Apparatus and methods for loading a drug eluting medical device |
US8616040B2 (en) | 2010-09-17 | 2013-12-31 | Medtronic Vascular, Inc. | Method of forming a drug-eluting medical device |
US10188436B2 (en) | 2010-11-09 | 2019-01-29 | Loma Vista Medical, Inc. | Inflatable medical devices |
CA3051684C (en) | 2011-12-06 | 2020-06-16 | Aortic Innovations Llc | Device for endovascular aortic repair and method of using the same |
US8992595B2 (en) | 2012-04-04 | 2015-03-31 | Trivascular, Inc. | Durable stent graft with tapered struts and stable delivery methods and devices |
US9498363B2 (en) | 2012-04-06 | 2016-11-22 | Trivascular, Inc. | Delivery catheter for endovascular device |
EP2908783B1 (en) | 2012-10-22 | 2020-08-05 | Roxwood Medical, Inc. | Apparatus for centering a microcatheter within a vasculature |
US20140120324A1 (en) * | 2012-10-30 | 2014-05-01 | W. L. Gore & Associates, Inc. | Implantable devices with corrodible materials and method of making same |
US9486340B2 (en) | 2013-03-14 | 2016-11-08 | Medtronic Vascular, Inc. | Method for manufacturing a stent and stent manufactured thereby |
US10271975B2 (en) * | 2013-03-15 | 2019-04-30 | Atrium Medical Corporation | Stent device having reduced foreshortening and recoil and method of making same |
CN105163794B (en) | 2013-03-15 | 2020-03-27 | 塔里斯生物医药公司 | Drug delivery device and method with drug permeable member |
EP3003230B1 (en) | 2013-06-05 | 2018-07-25 | Aortic Innovations Surena, LLC | Variable depression stents (vds) and billowing graft assemblies |
EP4234036A3 (en) | 2013-08-19 | 2023-11-01 | TARIS Biomedical LLC | Multi-unit drug delivery devices |
KR102486216B1 (en) | 2014-06-26 | 2023-01-09 | 타리스 바이오메디컬 엘엘씨 | Intravesical drug delivery devices and methods including elastic polymer-drug matrix systems |
US10363399B2 (en) | 2014-09-30 | 2019-07-30 | Boston Scientific Scimed, Inc. | Dual-layer balloon design and method of making the same |
WO2016054536A1 (en) * | 2014-10-02 | 2016-04-07 | Boston Scientific Scimed, Inc. | Controlled ingrowth feature for antimigration |
EP3285850A1 (en) | 2015-04-23 | 2018-02-28 | TARIS Biomedical LLC | Drug delivery devices with drug-permeable component and methods |
EP3325079B1 (en) | 2015-07-23 | 2023-09-06 | Novaflux, Inc. | Implants and constructs including hollow fibers |
US10596354B2 (en) | 2015-09-25 | 2020-03-24 | Mark Taber | Guide wires, catheters, and guide wire catheter systems and methods |
EP3503852B1 (en) * | 2016-08-24 | 2020-06-03 | W. L. Gore & Associates, Inc. | Sleeves for expandable medical devices |
US20230293774A1 (en) * | 2022-03-15 | 2023-09-21 | Merit Medical Systems, Inc. | Stent graft with elastomeric impermeable layer |
Family Cites Families (50)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
SE445884B (en) | 1982-04-30 | 1986-07-28 | Medinvent Sa | DEVICE FOR IMPLANTATION OF A RODFORM PROTECTION |
US4733665C2 (en) | 1985-11-07 | 2002-01-29 | Expandable Grafts Partnership | Expandable intraluminal graft and method and apparatus for implanting an expandable intraluminal graft |
SE453258B (en) | 1986-04-21 | 1988-01-25 | Medinvent Sa | ELASTIC, SELF-EXPANDING PROTEST AND PROCEDURE FOR ITS MANUFACTURING |
US4800882A (en) | 1987-03-13 | 1989-01-31 | Cook Incorporated | Endovascular stent and delivery system |
US4886062A (en) | 1987-10-19 | 1989-12-12 | Medtronic, Inc. | Intravascular radially expandable stent and method of implant |
DE8904026U1 (en) | 1988-04-20 | 1989-05-24 | Schneider (Europe) Ag, Zuerich, Ch | |
US5545208A (en) | 1990-02-28 | 1996-08-13 | Medtronic, Inc. | Intralumenal drug eluting prosthesis |
US5411550A (en) | 1991-09-16 | 1995-05-02 | Atrium Medical Corporation | Implantable prosthetic device for the delivery of a bioactive material |
US5500013A (en) | 1991-10-04 | 1996-03-19 | Scimed Life Systems, Inc. | Biodegradable drug delivery vascular stent |
US5254089A (en) | 1992-04-02 | 1993-10-19 | Boston Scientific Corp. | Medication dispensing balloon catheter |
US5342348A (en) * | 1992-12-04 | 1994-08-30 | Kaplan Aaron V | Method and device for treating and enlarging body lumens |
US5981568A (en) | 1993-01-28 | 1999-11-09 | Neorx Corporation | Therapeutic inhibitor of vascular smooth muscle cells |
US5411549A (en) * | 1993-07-13 | 1995-05-02 | Scimed Life Systems, Inc. | Selectively expandable, retractable and removable stent |
US5735892A (en) * | 1993-08-18 | 1998-04-07 | W. L. Gore & Associates, Inc. | Intraluminal stent graft |
US5409012A (en) | 1993-12-30 | 1995-04-25 | Boston Scientific Corporation | Sample collection using catheter with expandable member |
US5486191A (en) | 1994-02-02 | 1996-01-23 | John Hopkins University | Winged biliary stent |
US5609627A (en) * | 1994-02-09 | 1997-03-11 | Boston Scientific Technology, Inc. | Method for delivering a bifurcated endoluminal prosthesis |
US5810767A (en) | 1994-05-11 | 1998-09-22 | Localmed, Inc. | Method and apparatus for pressurized intraluminal drug delivery |
US5857998A (en) | 1994-06-30 | 1999-01-12 | Boston Scientific Corporation | Stent and therapeutic delivery system |
US5891108A (en) | 1994-09-12 | 1999-04-06 | Cordis Corporation | Drug delivery stent |
US5755722A (en) | 1994-12-22 | 1998-05-26 | Boston Scientific Corporation | Stent placement device with medication dispenser and method |
NL9500147A (en) * | 1995-01-26 | 1996-09-02 | Industrial Res Bv | A method of manufacturing a sheath-shaped stent from foil material and a stent obtained using this method. |
EP0814729B1 (en) * | 1995-03-10 | 2000-08-09 | Impra, Inc. | Endoluminal encapsulated stent and methods of manufacture |
US6124523A (en) * | 1995-03-10 | 2000-09-26 | Impra, Inc. | Encapsulated stent |
DE69626635T2 (en) | 1995-03-31 | 2003-12-18 | Boston Scient Corp | BALLOON CATHETER WITH SEVERAL HOLES FOR DISPOSAL OF MEDICINAL PRODUCTS |
US5609629A (en) * | 1995-06-07 | 1997-03-11 | Med Institute, Inc. | Coated implantable medical device |
US5603694A (en) | 1995-10-17 | 1997-02-18 | Brown; Joe E. | Infusion coil apparatus and method for delivering fluid-based agents intravascularly |
US5824046A (en) | 1996-09-27 | 1998-10-20 | Scimed Life Systems, Inc. | Covered stent |
ZA9710342B (en) | 1996-11-25 | 1998-06-10 | Alza Corp | Directional drug delivery stent and method of use. |
IT1289815B1 (en) * | 1996-12-30 | 1998-10-16 | Sorin Biomedica Cardio Spa | ANGIOPLASTIC STENT AND RELATED PRODUCTION PROCESS |
WO1998038947A1 (en) * | 1997-03-05 | 1998-09-11 | Scimed Life Systems, Inc. | Conformal laminate stent device |
US6048360A (en) * | 1997-03-18 | 2000-04-11 | Endotex Interventional Systems, Inc. | Methods of making and using coiled sheet graft for single and bifurcated lumens |
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 |
IL121882A0 (en) | 1997-10-05 | 1998-03-10 | Voinov Valerian | Expandable stent with bioabsorbable local drug delivery and technology for its manufacture |
US6273908B1 (en) * | 1997-10-24 | 2001-08-14 | Robert Ndondo-Lay | Stents |
AU749980B2 (en) * | 1997-11-07 | 2002-07-04 | Advanced Bio Prosthetic Surfaces, Ltd. | Metallic Intravascular Stent and Method of Manufacturing a Metallic Intravascular Stent |
US8029561B1 (en) | 2000-05-12 | 2011-10-04 | Cordis Corporation | Drug combination useful for prevention of restenosis |
US20020038146A1 (en) * | 1998-07-29 | 2002-03-28 | Ulf Harry | Expandable stent with relief cuts for carrying medicines and other materials |
US6547814B2 (en) | 1998-09-30 | 2003-04-15 | Impra, Inc. | Selective adherence of stent-graft coverings |
DE19855421C2 (en) * | 1998-11-02 | 2001-09-20 | Alcove Surfaces Gmbh | Implant |
US6558422B1 (en) * | 1999-03-26 | 2003-05-06 | University Of Washington | Structures having coated indentations |
US6287628B1 (en) * | 1999-09-03 | 2001-09-11 | Advanced Cardiovascular Systems, Inc. | Porous prosthesis and a method of depositing substances into the pores |
US6491666B1 (en) * | 1999-11-17 | 2002-12-10 | Microchips, Inc. | Microfabricated devices for the delivery of molecules into a carrier fluid |
US6379382B1 (en) * | 2000-03-13 | 2002-04-30 | Jun Yang | Stent having cover with drug delivery capability |
US6395326B1 (en) * | 2000-05-31 | 2002-05-28 | Advanced Cardiovascular Systems, Inc. | Apparatus and method for depositing a coating onto a surface of a prosthesis |
US6709451B1 (en) * | 2000-07-14 | 2004-03-23 | Norman Noble, Inc. | Channeled vascular stent apparatus and method |
US20020115986A1 (en) * | 2000-09-11 | 2002-08-22 | Shadduck John H. | Endovascular medical devices and techniques for delivering therapeutic agents |
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 |
US6752829B2 (en) * | 2001-01-30 | 2004-06-22 | Scimed Life Systems, Inc. | Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same |
-
2001
- 2001-01-30 US US09/774,218 patent/US6752829B2/en not_active Expired - Fee Related
-
2002
- 2002-01-30 CA CA002436241A patent/CA2436241A1/en not_active Abandoned
- 2002-01-30 WO PCT/US2002/002635 patent/WO2002060351A1/en active IP Right Grant
- 2002-01-30 EP EP02704283A patent/EP1355589B1/en not_active Expired - Lifetime
- 2002-01-30 AU AU2002237975A patent/AU2002237975B2/en not_active Ceased
- 2002-01-30 JP JP2002560548A patent/JP4271938B2/en not_active Expired - Fee Related
- 2002-01-30 DE DE0001355589T patent/DE02704283T1/en active Pending
- 2002-01-30 DE DE60221637T patent/DE60221637T2/en not_active Expired - Lifetime
-
2003
- 2003-08-04 US US10/633,864 patent/US6989071B2/en not_active Expired - Fee Related
-
2006
- 2006-01-20 US US11/337,235 patent/US20060122689A1/en not_active Abandoned
Cited By (27)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US8066763B2 (en) | 1998-04-11 | 2011-11-29 | Boston Scientific Scimed, Inc. | Drug-releasing stent with ceramic-containing layer |
US8574615B2 (en) | 2006-03-24 | 2013-11-05 | Boston Scientific Scimed, Inc. | Medical devices having nanoporous coatings for controlled therapeutic agent delivery |
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 |
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 |
US7981150B2 (en) | 2006-11-09 | 2011-07-19 | Boston Scientific Scimed, Inc. | Endoprosthesis with coatings |
US8070797B2 (en) | 2007-03-01 | 2011-12-06 | Boston Scientific Scimed, Inc. | Medical device with a porous surface for delivery of a therapeutic agent |
US8431149B2 (en) | 2007-03-01 | 2013-04-30 | Boston Scientific Scimed, Inc. | Coated medical devices for abluminal drug delivery |
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 |
US8002823B2 (en) | 2007-07-11 | 2011-08-23 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
US7942926B2 (en) | 2007-07-11 | 2011-05-17 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
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 |
US7931683B2 (en) | 2007-07-27 | 2011-04-26 | Boston Scientific Scimed, Inc. | Articles having ceramic coated surfaces |
US8221822B2 (en) | 2007-07-31 | 2012-07-17 | Boston Scientific Scimed, Inc. | Medical device coating by laser cladding |
US8900292B2 (en) | 2007-08-03 | 2014-12-02 | Boston Scientific Scimed, Inc. | Coating for medical device having increased surface area |
US8216632B2 (en) | 2007-11-02 | 2012-07-10 | Boston Scientific Scimed, Inc. | Endoprosthesis coating |
US8029554B2 (en) | 2007-11-02 | 2011-10-04 | Boston Scientific Scimed, Inc. | Stent with embedded material |
US7938855B2 (en) | 2007-11-02 | 2011-05-10 | Boston Scientific Scimed, Inc. | Deformable underlayer for stent |
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 |
US8231980B2 (en) | 2008-12-03 | 2012-07-31 | Boston Scientific Scimed, Inc. | Medical implants including iridium oxide |
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 |
Also Published As
Publication number | Publication date |
---|---|
US20060122689A1 (en) | 2006-06-08 |
WO2002060351A1 (en) | 2002-08-08 |
US20020103527A1 (en) | 2002-08-01 |
DE02704283T1 (en) | 2004-04-22 |
US6752829B2 (en) | 2004-06-22 |
AU2002237975B2 (en) | 2006-08-17 |
DE60221637T2 (en) | 2008-05-21 |
US6989071B2 (en) | 2006-01-24 |
EP1355589A1 (en) | 2003-10-29 |
JP2005503184A (en) | 2005-02-03 |
JP4271938B2 (en) | 2009-06-03 |
DE60221637D1 (en) | 2007-09-20 |
US20040030218A1 (en) | 2004-02-12 |
EP1355589B1 (en) | 2007-08-08 |
Similar Documents
Publication | Publication Date | Title |
---|---|---|
US6752829B2 (en) | Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same | |
AU2002237975A1 (en) | Stent with channel(s) for containing and delivering a biologically active material and method for manufacturing the same | |
US7326245B2 (en) | Medical device for delivering biologically active material | |
AU2003219687B2 (en) | Medical device for delivering biologically active material | |
US6758859B1 (en) | Increased drug-loading and reduced stress drug delivery device | |
EP2173400B1 (en) | Implantable medical devices having adjustable pore volume and methods for making the same | |
US20040059409A1 (en) | Method of applying coatings to a medical device | |
US20050203606A1 (en) | Stent system for preventing restenosis | |
US20050266040A1 (en) | Medical devices composed of porous metallic materials for delivering biologically active materials | |
US20070239253A1 (en) | Oscillation assisted drug elution apparatus and method | |
US20060025848A1 (en) | Medical device having a coating layer with structural elements therein and method of making the same | |
US20090319026A1 (en) | Composite Stent with Reservoirs for Drug Delivery and Methods of Manufacturing | |
AU2003219687A1 (en) | Medical device for delivering biologically active material | |
WO2003039768A1 (en) | Method for coating a medical device using uv laserto ablate exce ss coating | |
US20070224239A1 (en) | Method of making a coated medical device |
Legal Events
Date | Code | Title | Description |
---|---|---|---|
EEER | Examination request | ||
FZDE | Discontinued | ||
FZDE | Discontinued |
Effective date: 20120130 |