US20020091440A1 - Drug delivery graft - Google Patents
Drug delivery graft Download PDFInfo
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- US20020091440A1 US20020091440A1 US10/062,788 US6278802A US2002091440A1 US 20020091440 A1 US20020091440 A1 US 20020091440A1 US 6278802 A US6278802 A US 6278802A US 2002091440 A1 US2002091440 A1 US 2002091440A1
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- Prior art keywords
- graft
- drug delivery
- drug
- wall
- hollow tubing
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- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/14—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L31/16—Biologically active materials, e.g. therapeutic substances
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/14—Macromolecular materials
- A61L27/16—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L27/00—Materials for grafts or prostheses or for coating grafts or prostheses
- A61L27/50—Materials characterised by their function or physical properties, e.g. injectable or lubricating compositions, shape-memory materials, surface modified materials
- A61L27/54—Biologically active materials, e.g. therapeutic substances
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L31/00—Materials for other surgical articles, e.g. stents, stent-grafts, shunts, surgical drapes, guide wires, materials for adhesion prevention, occluding devices, surgical gloves, tissue fixation devices
- A61L31/04—Macromolecular materials
- A61L31/048—Macromolecular materials obtained by reactions only involving carbon-to-carbon unsaturated bonds
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61L—METHODS OR APPARATUS FOR STERILISING MATERIALS OR OBJECTS IN GENERAL; DISINFECTION, STERILISATION OR DEODORISATION OF AIR; CHEMICAL ASPECTS OF BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES; MATERIALS FOR BANDAGES, DRESSINGS, ABSORBENT PADS OR SURGICAL ARTICLES
- A61L2300/00—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices
- A61L2300/40—Biologically active materials used in bandages, wound dressings, absorbent pads or medical devices characterised by a specific therapeutic activity or mode of action
- A61L2300/416—Anti-neoplastic or anti-proliferative or anti-restenosis or anti-angiogenic agents, e.g. paclitaxel, sirolimus
Definitions
- the present invention relates to medical devices, and more particularly, to a graft for delivering an agent into a natural tissue conduit, e.g., a blood vessel.
- a natural tissue conduit e.g., a blood vessel.
- Stents and other existing devices are frequently coated with or impregnated with therapeutic agents for the treatment of diseases.
- a concern related to the use of stents and existing devices for drug delivery is that drug delivery may not be sustainable. Over time the concentration of drug on the stent or other similar delivery devices will diminish, through drug inactivation, degradation, or dilution. Thus, the therapeutic agent may need to be refreshed or even changed after implant of the device.
- these existing devices are not capable of delivering drugs to an internal lumen along the entire length of the graft.
- a drug delivery graft capable of delivering a drug or any other agent to the internal lumen along the entire length of the graft, or restrict delivery to a finite area on the graft such that the agent may be renewed or altered after implant of the graft.
- a desirable drug delivery graft could be implanted in the same fashion as regular vascular grafts.
- an improved drug delivery graft is provided.
- the invention can be used, for example, as a vascular graft providing sustained release of a selected bioactive or diagnostic agent directly into a blood or other fluid flow pathway.
- the graft is capable of delivering the bioactive or diagnostic agent to the internal lumen of a vascular graft along the entire length, or of restricting delivery to a finite area of the vascular graft.
- the graft is preferably made of expanded polytetrafluoroethylene (ePTFE), but could certainly be made of any other porous type graft.
- ePTFE expanded polytetrafluoroethylene
- Various ePTFE grafts that are reinforced by external beading are well known in the art.
- one embodiment of the present invention utilizes a hollow tubing as a drug conduit.
- the hollow tubing behaves much like the existing low profile solid beading in that it has a small diameter and can be readily implanted into the body, offering advantages as both a spiral support and drug conduit.
- a simple tubular ePTFE graft is used, which is well known to be extremely porous.
- a hollow tubing of non-porous PTFE, fluoroethylene polymer (FEP) or other implantable polymer is wrapped around the graft and laminated or adhered in place.
- the hollow tubing may be wrapped helically; alternatively other arrangements (e.g., end to end loops) can be used.
- one surface of the hollow tubing is cut away (for example, laser cut), punctured repeatedly or otherwise rendered porous.
- the drug When an agent such as a drug is injected into the hollow tubing, e.g., from an infusion pump or a subcutaneous access port, the drug flows through the hollow tubing and leaks through the cut or porous region and diffuses into the outer surface of the ePTFE graft.
- the drug diffuses into the graft where it mixes into the blood flowing therethrough and influences biological processes along the circulatory system.
- the dispensed material could have either systemic effect or have limited local effect.
- One particularly attractive use of the device is to dispense drugs to limit the restenosis that frequently occurs due to tissue proliferation at the site of anastimosis of an ePTFE graft to a blood vessel.
- the invention takes advantage of the well-known porosity of an ePTFE graft. Impregnation of ePTFE grafts with therapeutic agents has been previously disclosed. However, the present invention allows the therapeutic agents to be renewed or altered following implant of the graft, something that is not possible with simple drug-impregnated graft materials.
- FIG. 1 is a side view of a drug delivery graft according to an embodiment of the present invention
- FIG. 2 is a side view of a hollow tubing according to an embodiment of the present invention.
- FIG. 3 is a cross-sectional view of the drug delivery graft showing a cut portion of the hollow tubing according to an embodiment of the present invention.
- FIG. 4 is a cross-sectional view of the drug delivery graft showing a porous hollow tubing according to an embodiment of the present invention.
- FIG. 5 is a side view of an alternate embodiment of the drug delivery graft of the present invention.
- FIG. 6 is a side view of another alternate embodiment of the drug delivery graft of the present invention.
- the present invention satisfies the need for an improved drug delivery graft capable of delivering bioactive agents, including drugs, to an internal lumen of a graft, either along its entire length or in a localized area, through the use of hollow tubing on the outside of the graft.
- bioactive agents including drugs
- FIG. 1 a side view of a drug delivery graft 10 in accordance with an embodiment of the present invention is illustrated.
- the drug delivery graft 10 comprises a graft 2 , a hollow tubing 4 , and a drug source 6 .
- the hollow tubing 4 is wrapped (spiraled) in a helical fashion around an abluminal surface of the graft 2 .
- the drug source 6 is connected to one end 14 of the hollow tubing 4 .
- the graft 2 may be a standard clinical vascular graft of any shape or size comprised preferably of expanded polytetrafluoroethylene (ePTFE), which material consists of a porous network of nodes and fibrils created during the expansion process. This porous network provides a somewhat permeable wall for the graft 2 .
- ePTFE expanded polytetrafluoroethylene
- the graft 2 can be constructed in a variety of sizes to allow a surgeon to select the appropriate size to accommodate a particular vascular application. Likewise, the porosity (internodal distance) of the graft can be varied to affect the rate of drug or agent release.
- the drug delivery graft 10 injects a drug or other agent into the bore of the hollow tubing 4 from the drug source 6 .
- the drug source 6 can be any of a variety of commercially and technologically available systems that provide constant controlled rate delivery of an agent, such as a biologically activated mini pump that is either subcutaneously or extracorporeally located, an external mechanical pump, or an access port.
- an open end 14 of the hollow tubing 4 may be connected via a micro-catheter to a subcutaneous or other drug source.
- the agent delivered to the natural tissue conduit can be any substance, including any drug, and the device can be used for local or systemic delivery of such substances to prevent or treat a variety of disease syndromes or to promote or enhance desired activity within the body.
- a bioactive or diagnostic agent may include, for example, therapeutic or prophylactic agents, such as a drug, protein, enzyme, antibody or other agent, or cells that produce a drug, protein, enzyme, antibody, or other agent.
- the diagnostic material can include, for example, a radiolabeled antibody or antigen.
- the natural tissue conduit into which the agent is ultimately delivered may include any structure of a body that functions to transport substances and includes, but is not limited to, e.g., blood vessels of the cardiovascular system (arteries and veins), the lymphatic system, the intestinal tract (esophagus, stomach, the small and large intestines, and colon), the portal system of the liver, the gall bladder and bile duct, the urinary system (bladder, and urethra), the respiratory system (trachea, bronchi and bronchioles), and ducts and ductules connecting endocrine organs to other areas of the body.
- the device of the present invention can be used in any mammal or in any animal in which natural tissue conduits are found. Suitable dosage requirements and treatment regimens for any agent delivered can be determined and will vary depending upon the tissue targeted for therapy and upon the particular agent utilized.
- the hollow tubing 4 may be manufactured from a non-expanded or partially expanded small diameter PTFE tube or any other implantable polymer (e.g. FEP).
- the hollow tubing 4 may be manufactured in very small diameters (less than 1 mm) and long lengths (more than 10 feet) to accommodate all sizes of grafts.
- the prior art beading used solely for support purposes is a solid filament
- the hollow tubing 4 has a bore to provide fluid delivery to the graft 2 .
- the hollow tubing 4 has an uncut portion 16 and a partially cut portion 12 (or a porous and less or non-porous region arrange circumferentially) that allows communication between the lumen of the hollow tubing 4 and the outside surface of the graft 2 .
- communication between the lumen of the hollow tubing 4 and the outside surface of the graft 2 may be achieved by using a porous hollow tubing or a hollow tubing with mechanical or laser perforations.
- the hollow tubing 4 is shown generally cylindrical in shape, it should be appreciated that alternative designs are possible including a hollow tubing that is tapered along its length as well as one that has a stepped configuration or has other, non-circular cross-sections.
- the graft may be tapered or stepped or of a special shape, such as cuffed, as is known in the art.
- a specified length of a tube made of PTFE, FEP or other any other implantable polymer may be loaded on a mandrel to secure the tube in a rigid fashion.
- the loaded tube may be placed in a cutting device where a defined portion of the tube is cut in the longitudinal direction.
- a semi-circular “half-tube” C-shaped section 12 may be created in the middle of the tube to create the hollow tubing 4 .
- the cutting device may comprise a LASER cutting device.
- the tube may be punctured repeatedly or otherwise rendered porous to allow release of the agent into the ePTFE of the graft.
- One end 18 of the hollow tubing 4 may be sealed mechanically, for example by a crimp, or by a heating process to terminate the lumen.
- the terminated end 18 may also be sealed with a silicon or other self-sealing material that can advantageously serve as a primer port for infusing an agent through, for example, a syringe.
- FIG. 3 a cross-sectional view of the drug delivery graft showing a cut portion of hollow tubing according to an embodiment of the present invention is illustrated.
- Hollow tubing 4 is wound spirally around the graft 2 .
- a cutaway portion 12 of the hollow tubing 4 is laminated and secured against the outer surface of the graft 2 , creating a drug outflow surface that communicates with the outer lumen of the graft 2 .
- FIG. 4 shows a cross-sectional view of the drug delivery graft showing a porous hollow tubing 24 according to an alternative embodiment of the present invention.
- the porous hollow tubing 24 comprises perforations or pores 22 through which an agent or drug is dispensed onto and into the graft 2 .
- the agent or drug is evenly distributed and diffuses into the graft 2 through the interstices of an agent infusion area 8 .
- the rate at which the drug or other agent penetrates the porous wall of the graft 2 is determined by several factors, including the size and number of the pores and the size of the drug molecule.
- the graft 2 is capable of delivering drugs or any other agents to the internal lumen along the entire length of the graft 2 , or of restricting delivery to a finite area on the graft 2 .
- the spacing of the hollow tubing 4 along the graft 2 can be varied to concentrate dosages in certain areas of need.
- the spiraling of the hollow tubing 4 around the graft 2 could be combined with a traditional support beading spiraled around the graft 2 for additional support.
- Drug delivery graft 30 includes graft 32 and hollow tubing 34 .
- the hollow tubing 34 is arranged longitudinally along the graft 32 , rather than wrapped around spirally as in FIG. 1.
- the hollow tubing 34 is arranged in a snake-like fashion, longitudinally along the outside of the graft 32 , and is connected to the drug source 6 at one end.
- the longitudinally arranged strips of hollow tubing 34 loop back at the ends of the graft so that a single continuous piece of hollow tubing is employed.
- hollow tubing 44 is arranged longitudinally along a graft 42 in a slightly different configuration to make up a drug delivery graft 40 .
- the longitudinally arranged hollow tubing 44 is connected to manifolds 46 and 48 at each end.
- the manifold 46 located at a proximal end of the graft 42 , is circumferentially arranged around the graft 42 and is also connected to the drug source 6 .
- the manifold 48 located at a distal end of the graft 42 is circumferentially arranged around the graft 42 in a closed loop.
- the drug provided from the drug source 6 flows into the manifold 46 where it is distributed to the longitudinally placed hollow tubing 44 , flowing through the hollow tubing 44 and along the manifold 48 , being distributed to the graft 42 in one of the above-mentioned methods shown in FIGS. 2 - 4 .
- the hollow tubing can be spaced equidistant or varied depending on the required application.
- the spiraled or longitudinally-placed hollow tubing is sintered to the graft to adhere the hollow tubing to the graft in the same manner as existing standard grafts, adhering the cut (C-shaped) portion 12 and uncut hollow tubing portion 16 as shown in FIG. 3, or the porous hollow tubing 24 as shown in FIG. 4, along the length of the graft 2 .
- any of a number of known adhesive agents can be used to attach the hollow tubing.
- the hollow tubing may be produced from a plastic material such as polypropylene, which can be adhered to the graft through a partial melting process.
- the design may use the existing low profile hollow tubing on existing grafts, for example IMPRAFlex® grafts, manufactured by IMPRA (Tempe, Ariz.), a Division of C. R. Bard, Inc., and can be implanted in the same fashion as regularly used existing vascular grafts.
- existing grafts for example IMPRAFlex® grafts, manufactured by IMPRA (Tempe, Ariz.), a Division of C. R. Bard, Inc.
- the devices of the present invention can function as improved vascular grafts such that the agent or drug to be delivered prevents or treats complications associated with conventional vascular graft placement, including but not limited to platelet deposition, coagulation, thrombosis, neointimal hyperplasia and fibrosis.
- complications associated with conventional vascular graft placement including but not limited to platelet deposition, coagulation, thrombosis, neointimal hyperplasia and fibrosis.
- One particularly attractive use of the drug delivery graft would be to dispense drugs or any other agent to limit the stenosis that frequently occurs at the site of anastimosis of an ePTFE graft to a blood vessel.
- agents that prevent restenosis of a blood vessel include, but are not limited to, a growth factor, a growth factor inhibitor, growth factor receptor antagonist, transcriptional repressor, translational repressor, antisense DNA, antisense RNA, replication inhibitor, anti-microtubule agents, inhibitory antibodies, antibodies directed against growth factors or their receptors, bifunctional molecules comprising a growth factor and a cytotoxin, and bifunctional molecules comprising an antibody and a cytotoxin.
Abstract
An improved drug delivery graft comprises a drug delivery device coupled to an outer wall of a porous graft. An agent is conducted by the drug delivery device from a source to the outer wall of the graft where it is released to diffuse into the lumen of the graft through porous interstices of the outer wall.
Description
- The present invention relates to medical devices, and more particularly, to a graft for delivering an agent into a natural tissue conduit, e.g., a blood vessel.
- Providing frequent, direct delivery of bioactive agents to a natural tissue conduit has become a necessity for many medical treatments such as those requiring frequent intravenous administration of drugs. To meet this need, many types of devices including stents and vascular grafts have been used to deliver agents into natural tissue conduits.
- Local delivery is advantageous in that the effective local concentration of a delivered drug can be much higher than can normally be achieved by systemic administration. Delivery of agents to vascular tissue to prevent restenosis is especially useful. U.S. Pat. No. 5,399,352 to Hanson discloses a device for delivering an effective concentration of a therapeutic agent locally at a target site within the body without producing unwanted systemic side effects. However, the device described in this reference differs considerably from existing vascular grafts. It would be especially advantageous to deliver drugs with a device more similar to currently used vascular grafts.
- Stents and other existing devices are frequently coated with or impregnated with therapeutic agents for the treatment of diseases. A concern related to the use of stents and existing devices for drug delivery is that drug delivery may not be sustainable. Over time the concentration of drug on the stent or other similar delivery devices will diminish, through drug inactivation, degradation, or dilution. Thus, the therapeutic agent may need to be refreshed or even changed after implant of the device. Moreover, these existing devices are not capable of delivering drugs to an internal lumen along the entire length of the graft.
- Accordingly, it would be desirable to provide a drug delivery graft capable of delivering a drug or any other agent to the internal lumen along the entire length of the graft, or restrict delivery to a finite area on the graft such that the agent may be renewed or altered after implant of the graft. Furthermore, a desirable drug delivery graft could be implanted in the same fashion as regular vascular grafts.
- In accordance with the teachings of the present invention, an improved drug delivery graft is provided. The invention can be used, for example, as a vascular graft providing sustained release of a selected bioactive or diagnostic agent directly into a blood or other fluid flow pathway. The graft is capable of delivering the bioactive or diagnostic agent to the internal lumen of a vascular graft along the entire length, or of restricting delivery to a finite area of the vascular graft. The graft is preferably made of expanded polytetrafluoroethylene (ePTFE), but could certainly be made of any other porous type graft. Various ePTFE grafts that are reinforced by external beading are well known in the art. However, unlike previous designs that utilize a solid beading for reinforcing purposes, one embodiment of the present invention utilizes a hollow tubing as a drug conduit. The hollow tubing behaves much like the existing low profile solid beading in that it has a small diameter and can be readily implanted into the body, offering advantages as both a spiral support and drug conduit.
- In a preferred embodiment of the present invention, a simple tubular ePTFE graft is used, which is well known to be extremely porous. A hollow tubing of non-porous PTFE, fluoroethylene polymer (FEP) or other implantable polymer is wrapped around the graft and laminated or adhered in place. The hollow tubing may be wrapped helically; alternatively other arrangements (e.g., end to end loops) can be used. Before the wrapping occurs, one surface of the hollow tubing is cut away (for example, laser cut), punctured repeatedly or otherwise rendered porous. When an agent such as a drug is injected into the hollow tubing, e.g., from an infusion pump or a subcutaneous access port, the drug flows through the hollow tubing and leaks through the cut or porous region and diffuses into the outer surface of the ePTFE graft. The drug diffuses into the graft where it mixes into the blood flowing therethrough and influences biological processes along the circulatory system. Depending on the drug used and the precise configuration of the device the dispensed material could have either systemic effect or have limited local effect. One particularly attractive use of the device is to dispense drugs to limit the restenosis that frequently occurs due to tissue proliferation at the site of anastimosis of an ePTFE graft to a blood vessel.
- The invention takes advantage of the well-known porosity of an ePTFE graft. Impregnation of ePTFE grafts with therapeutic agents has been previously disclosed. However, the present invention allows the therapeutic agents to be renewed or altered following implant of the graft, something that is not possible with simple drug-impregnated graft materials.
- A more complete understanding of the ePTFE drug delivery graft will be afforded to those skilled in the art, as well as a realization of additional advantages and objects thereof, by a consideration of the following detailed description of the preferred embodiment. Reference will be made to the appended sheets of drawings that will first be described briefly.
- FIG. 1 is a side view of a drug delivery graft according to an embodiment of the present invention;
- FIG. 2 is a side view of a hollow tubing according to an embodiment of the present invention;
- FIG. 3 is a cross-sectional view of the drug delivery graft showing a cut portion of the hollow tubing according to an embodiment of the present invention.
- FIG. 4 is a cross-sectional view of the drug delivery graft showing a porous hollow tubing according to an embodiment of the present invention.
- FIG. 5 is a side view of an alternate embodiment of the drug delivery graft of the present invention.
- FIG. 6 is a side view of another alternate embodiment of the drug delivery graft of the present invention.
- The following detailed description illustrates the invention by way of example, not by way of limitation, the principles of the invention. This description will clearly enable one skilled in the art to make and use the invention, and describes several embodiments, adaptations, variations, alternatives and uses of the invention, including what we presently believe is the best mode of carrying out the invention.
- The present invention satisfies the need for an improved drug delivery graft capable of delivering bioactive agents, including drugs, to an internal lumen of a graft, either along its entire length or in a localized area, through the use of hollow tubing on the outside of the graft. In the detailed description that follows, it should be appreciated that like reference numerals are used to identify like elements illustrated in one or more of the figures.
- Referring first to FIG. 1, a side view of a
drug delivery graft 10 in accordance with an embodiment of the present invention is illustrated. Thedrug delivery graft 10 comprises agraft 2, ahollow tubing 4, and adrug source 6. Thehollow tubing 4 is wrapped (spiraled) in a helical fashion around an abluminal surface of thegraft 2. Thedrug source 6 is connected to oneend 14 of thehollow tubing 4. - The
graft 2 may be a standard clinical vascular graft of any shape or size comprised preferably of expanded polytetrafluoroethylene (ePTFE), which material consists of a porous network of nodes and fibrils created during the expansion process. This porous network provides a somewhat permeable wall for thegraft 2. Thegraft 2 can be constructed in a variety of sizes to allow a surgeon to select the appropriate size to accommodate a particular vascular application. Likewise, the porosity (internodal distance) of the graft can be varied to affect the rate of drug or agent release. - The
drug delivery graft 10 injects a drug or other agent into the bore of thehollow tubing 4 from thedrug source 6. Thedrug source 6 can be any of a variety of commercially and technologically available systems that provide constant controlled rate delivery of an agent, such as a biologically activated mini pump that is either subcutaneously or extracorporeally located, an external mechanical pump, or an access port. For example, anopen end 14 of thehollow tubing 4 may be connected via a micro-catheter to a subcutaneous or other drug source. - The agent delivered to the natural tissue conduit can be any substance, including any drug, and the device can be used for local or systemic delivery of such substances to prevent or treat a variety of disease syndromes or to promote or enhance desired activity within the body. A bioactive or diagnostic agent may include, for example, therapeutic or prophylactic agents, such as a drug, protein, enzyme, antibody or other agent, or cells that produce a drug, protein, enzyme, antibody, or other agent. The diagnostic material can include, for example, a radiolabeled antibody or antigen.
- The natural tissue conduit into which the agent is ultimately delivered may include any structure of a body that functions to transport substances and includes, but is not limited to, e.g., blood vessels of the cardiovascular system (arteries and veins), the lymphatic system, the intestinal tract (esophagus, stomach, the small and large intestines, and colon), the portal system of the liver, the gall bladder and bile duct, the urinary system (bladder, and urethra), the respiratory system (trachea, bronchi and bronchioles), and ducts and ductules connecting endocrine organs to other areas of the body. The device of the present invention can be used in any mammal or in any animal in which natural tissue conduits are found. Suitable dosage requirements and treatment regimens for any agent delivered can be determined and will vary depending upon the tissue targeted for therapy and upon the particular agent utilized.
- Referring now to FIG. 2, a side view of the
hollow tubing 4 used in an embodiment of the present invention is illustrated. Thehollow tubing 4 may be manufactured from a non-expanded or partially expanded small diameter PTFE tube or any other implantable polymer (e.g. FEP). Thehollow tubing 4 may be manufactured in very small diameters (less than 1 mm) and long lengths (more than 10 feet) to accommodate all sizes of grafts. Whereas the prior art beading used solely for support purposes is a solid filament, thehollow tubing 4 has a bore to provide fluid delivery to thegraft 2. Preferably, thehollow tubing 4 has anuncut portion 16 and a partially cut portion 12 (or a porous and less or non-porous region arrange circumferentially) that allows communication between the lumen of thehollow tubing 4 and the outside surface of thegraft 2. Alternatively, communication between the lumen of thehollow tubing 4 and the outside surface of thegraft 2 may be achieved by using a porous hollow tubing or a hollow tubing with mechanical or laser perforations. While thehollow tubing 4, is shown generally cylindrical in shape, it should be appreciated that alternative designs are possible including a hollow tubing that is tapered along its length as well as one that has a stepped configuration or has other, non-circular cross-sections. Similarly the graft may be tapered or stepped or of a special shape, such as cuffed, as is known in the art. - In a preferred embodiment, to manufacture the
hollow tubing 4, a specified length of a tube made of PTFE, FEP or other any other implantable polymer may be loaded on a mandrel to secure the tube in a rigid fashion. The loaded tube may be placed in a cutting device where a defined portion of the tube is cut in the longitudinal direction. A semi-circular “half-tube” C-shapedsection 12 may be created in the middle of the tube to create thehollow tubing 4. The cutting device may comprise a LASER cutting device. Alternatively, the tube may be punctured repeatedly or otherwise rendered porous to allow release of the agent into the ePTFE of the graft. Oneend 18 of thehollow tubing 4 may be sealed mechanically, for example by a crimp, or by a heating process to terminate the lumen. The terminatedend 18 may also be sealed with a silicon or other self-sealing material that can advantageously serve as a primer port for infusing an agent through, for example, a syringe. - Referring now to FIG. 3, a cross-sectional view of the drug delivery graft showing a cut portion of hollow tubing according to an embodiment of the present invention is illustrated.
Hollow tubing 4 is wound spirally around thegraft 2. During the spiraling process, acutaway portion 12 of thehollow tubing 4 is laminated and secured against the outer surface of thegraft 2, creating a drug outflow surface that communicates with the outer lumen of thegraft 2. Alternatively, FIG. 4 shows a cross-sectional view of the drug delivery graft showing a poroushollow tubing 24 according to an alternative embodiment of the present invention. The poroushollow tubing 24 comprises perforations or pores 22 through which an agent or drug is dispensed onto and into thegraft 2. The agent or drug is evenly distributed and diffuses into thegraft 2 through the interstices of anagent infusion area 8. The rate at which the drug or other agent penetrates the porous wall of thegraft 2 is determined by several factors, including the size and number of the pores and the size of the drug molecule. - The
graft 2 is capable of delivering drugs or any other agents to the internal lumen along the entire length of thegraft 2, or of restricting delivery to a finite area on thegraft 2. In addition, it should be appreciated that the spacing of thehollow tubing 4 along thegraft 2 can be varied to concentrate dosages in certain areas of need. Moreover, the spiraling of thehollow tubing 4 around thegraft 2, as shown in FIG. 1, could be combined with a traditional support beading spiraled around thegraft 2 for additional support. - Turning now to FIG. 5, an alternate embodiment of the present invention is shown.
Drug delivery graft 30 includesgraft 32 andhollow tubing 34. In this embodiment, thehollow tubing 34 is arranged longitudinally along thegraft 32, rather than wrapped around spirally as in FIG. 1. Thehollow tubing 34 is arranged in a snake-like fashion, longitudinally along the outside of thegraft 32, and is connected to thedrug source 6 at one end. The longitudinally arranged strips ofhollow tubing 34 loop back at the ends of the graft so that a single continuous piece of hollow tubing is employed. In a second alternate embodiment illustrated in FIG. 6,hollow tubing 44 is arranged longitudinally along agraft 42 in a slightly different configuration to make up adrug delivery graft 40. In this embodiment, the longitudinally arrangedhollow tubing 44 is connected to manifolds 46 and 48 at each end. The manifold 46, located at a proximal end of thegraft 42, is circumferentially arranged around thegraft 42 and is also connected to thedrug source 6. The manifold 48, located at a distal end of thegraft 42 is circumferentially arranged around thegraft 42 in a closed loop. The drug provided from thedrug source 6 flows into the manifold 46 where it is distributed to the longitudinally placedhollow tubing 44, flowing through thehollow tubing 44 and along the manifold 48, being distributed to thegraft 42 in one of the above-mentioned methods shown in FIGS. 2-4. It should be appreciated that in both embodiments shown in FIGS. 5 and 6, the hollow tubing can be spaced equidistant or varied depending on the required application. - The spiraled or longitudinally-placed hollow tubing is sintered to the graft to adhere the hollow tubing to the graft in the same manner as existing standard grafts, adhering the cut (C-shaped)
portion 12 and uncuthollow tubing portion 16 as shown in FIG. 3, or the poroushollow tubing 24 as shown in FIG. 4, along the length of thegraft 2. Alternatively, any of a number of known adhesive agents can be used to attach the hollow tubing. Further, the hollow tubing may be produced from a plastic material such as polypropylene, which can be adhered to the graft through a partial melting process. Thus, the design may use the existing low profile hollow tubing on existing grafts, for example IMPRAFlex® grafts, manufactured by IMPRA (Tempe, Ariz.), a Division of C. R. Bard, Inc., and can be implanted in the same fashion as regularly used existing vascular grafts. - The devices of the present invention can function as improved vascular grafts such that the agent or drug to be delivered prevents or treats complications associated with conventional vascular graft placement, including but not limited to platelet deposition, coagulation, thrombosis, neointimal hyperplasia and fibrosis. One particularly attractive use of the drug delivery graft would be to dispense drugs or any other agent to limit the stenosis that frequently occurs at the site of anastimosis of an ePTFE graft to a blood vessel. Examples of agents that prevent restenosis of a blood vessel include, but are not limited to, a growth factor, a growth factor inhibitor, growth factor receptor antagonist, transcriptional repressor, translational repressor, antisense DNA, antisense RNA, replication inhibitor, anti-microtubule agents, inhibitory antibodies, antibodies directed against growth factors or their receptors, bifunctional molecules comprising a growth factor and a cytotoxin, and bifunctional molecules comprising an antibody and a cytotoxin.
- The present invention has been described above in terms of a presently preferred embodiment so that an understanding of the present invention can be conveyed. However, there are many alternative arrangements for an expanded PTFE drug delivery graft not specifically described herein but with which the present invention is applicable. The scope of the present invention should therefore not be limited by the embodiments illustrated, but rather it should be understood that the present invention has wide applicability with respect to drug delivery grafts generally. All modifications, variations, or equivalent elements and implementations that are within the scope of the appended claims should therefore be considered within the scope of the invention.
Claims (9)
1. A drug delivery graft, comprising:
a graft comprising a lumen defined by an outer wall, wherein the outer wall is characterized by a microstructure having nodes interconnected by fibrils; and
drug delivery means coupled to the outer wall for delivering a drug thereto, wherein the drug diffuses into the lumen through the outer wall.
2. The drug delivery graft according to claim 1 , further comprising a drug source coupled to the drug delivery means.
3. The drug delivery graft according to claim 1 , wherein the drug delivery means comprises a hollow tube.
4. The drug delivery graft according to claim 3 , wherein the hollow tube is arranged substantially parallel to a longitudinal axis of the graft.
5. The drug delivery graft according to claim 3 , wherein the hollow tube comprises a cutaway portion in communication with the outer wall.
6. The drug delivery graft according to claim 3 , wherein the hollow tube comprises perforations in communication with the outer wall.
7. The drug delivery graft according to claim 3 , wherein the hollow tube comprises a porous wall in communication with the outer wall.
8. The drug delivery graft according to claim 1 , wherein the graft comprises expanded polytetrafluoroethylene.
9. The drug delivery graft according to claim 1 , wherein the drug is selected from the group consisting of a growth factor, a growth factor inhibitor, growth factor receptor antagonist, a transcriptional repressor, a translational repressor, an antisense nucleic acid, a replication inhibitor, an anti-microtubule agent, an inhibitory antibody, an antibody directed against a growth factor, a bifunctional molecules comprising a growth factor and a cytotoxin, and a bifunctional molecule comprising an antibody and a cytotoxin.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US10/062,788 US20020091440A1 (en) | 2000-01-20 | 2002-01-31 | Drug delivery graft |
Applications Claiming Priority (2)
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US09/488,625 US6355063B1 (en) | 2000-01-20 | 2000-01-20 | Expanded PTFE drug delivery graft |
US10/062,788 US20020091440A1 (en) | 2000-01-20 | 2002-01-31 | Drug delivery graft |
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US09/488,625 Continuation US6355063B1 (en) | 2000-01-20 | 2000-01-20 | Expanded PTFE drug delivery graft |
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EP (3) | EP1121945B1 (en) |
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2001
- 2001-01-18 JP JP2001552961A patent/JP4969752B2/en not_active Expired - Lifetime
- 2001-01-18 MX MXPA02007107A patent/MXPA02007107A/en not_active Application Discontinuation
- 2001-01-18 WO PCT/US2001/002061 patent/WO2001052914A1/en active Application Filing
- 2001-01-18 CA CA2397654A patent/CA2397654C/en not_active Expired - Lifetime
-
2002
- 2002-01-31 US US10/062,788 patent/US20020091440A1/en not_active Abandoned
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US8361136B2 (en) | 1998-02-09 | 2013-01-29 | Trivascular, Inc. | Endovascular graft |
US10548750B2 (en) | 1998-02-09 | 2020-02-04 | Trivascular, Inc. | Endovascular graft |
US9867727B2 (en) | 1998-02-09 | 2018-01-16 | Trivascular, Inc. | Endovascular graft |
US8801769B2 (en) | 1998-02-09 | 2014-08-12 | Trivascular, Inc. | Endovascular graft |
US20050186241A1 (en) * | 2000-11-17 | 2005-08-25 | Boyle Christopher T. | Device for in vivo delivery of bioactive agents and method of manufacture thereof |
US10398830B2 (en) | 2000-11-17 | 2019-09-03 | Vactronix Scientific, Llc | Device for in vivo delivery of bioactive agents and method of manufacture thereof |
US9107605B2 (en) | 2000-11-17 | 2015-08-18 | Advanced Bio Prosthetic Surfaces, Ltd., A Wholly Owned Subsidiary Of Palmaz Scientific, Inc. | Device for in vivo delivery of bioactive agents and method of manufacture thereof |
US7678217B2 (en) | 2001-12-20 | 2010-03-16 | Trivascular2, Inc. | Method for manufacturing an endovascular graft section |
US6926735B2 (en) * | 2002-12-23 | 2005-08-09 | Scimed Life Systems, Inc. | Multi-lumen vascular grafts having improved self-sealing properties |
US20040122507A1 (en) * | 2002-12-23 | 2004-06-24 | Scimed Life Systems, Inc. | Multi-lumen vascular grafts having improved self-sealing properties |
EP2332493A1 (en) | 2004-01-30 | 2011-06-15 | TriVascular, Inc. | Inflatable porous implants and methods for drug delivery |
US8267989B2 (en) | 2004-01-30 | 2012-09-18 | Trivascular, Inc. | Inflatable porous implants and methods for drug delivery |
US7803178B2 (en) | 2004-01-30 | 2010-09-28 | Trivascular, Inc. | Inflatable porous implants and methods for drug delivery |
WO2005074547A3 (en) * | 2004-01-30 | 2005-10-13 | Trivascular Inc | Inflatable porous implants and methods for drug delivery |
WO2005074547A2 (en) | 2004-01-30 | 2005-08-18 | Boston Scientific Santa Rosa Corporation | Inflatable porous implants and methods for drug delivery |
US20080234809A1 (en) * | 2007-03-23 | 2008-09-25 | Medtronic Vascular, Inc. | Stent Graft System With Injection Tube |
WO2015031789A1 (en) * | 2013-08-30 | 2015-03-05 | Novasentis, Inc. | Electromechanical polymer pumps |
US9507468B2 (en) | 2013-08-30 | 2016-11-29 | Novasentis, Inc. | Electromechanical polymer-based sensor |
US10125758B2 (en) | 2013-08-30 | 2018-11-13 | Novasentis, Inc. | Electromechanical polymer pumps |
Also Published As
Publication number | Publication date |
---|---|
WO2001052914A1 (en) | 2001-07-26 |
JP4969752B2 (en) | 2012-07-04 |
MXPA02007107A (en) | 2003-01-28 |
CA2397654A1 (en) | 2001-07-26 |
ES2642111T3 (en) | 2017-11-15 |
EP1121945B1 (en) | 2007-07-04 |
US6355063B1 (en) | 2002-03-12 |
EP1767229B1 (en) | 2017-08-16 |
EP1121945A1 (en) | 2001-08-08 |
CA2397654C (en) | 2010-03-16 |
EP2301592A1 (en) | 2011-03-30 |
EP2301592B1 (en) | 2015-10-14 |
DE60035404D1 (en) | 2007-08-16 |
DE60035404T2 (en) | 2008-03-06 |
JP2003520106A (en) | 2003-07-02 |
ES2288462T3 (en) | 2008-01-16 |
EP1767229A2 (en) | 2007-03-28 |
ES2550807T3 (en) | 2015-11-12 |
EP1767229A3 (en) | 2011-03-30 |
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Legal Events
Date | Code | Title | Description |
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STCB | Information on status: application discontinuation |
Free format text: ABANDONED -- FAILURE TO RESPOND TO AN OFFICE ACTION |