Patent Application
20120330342
The field of intralumenal therapy for the treatment of vascular disease states has for many years focused on the use of many different types of therapeutic devices. While it is currently unforeseeable that one particular device will be suitable to treat all types of vascular disease states it may however be possible to reduce the number of devices used for some disease states while at the same time improve patient outcomes at a reduced cost. To identify potential opportunities to improve the efficiency and efficacy of the devices and procedures it is important for one to understand the state of the art relative to some of the more common disease states.
For instance, one aspect of cerebrovascular disease in which the wall of a blood vessel becomes weakened. Under cerebral flow conditions the weakened vessel wall forms a bulge or aneurysm which can lead to symptomatic neurological deficits or ultimately a hemorrhagic stroke when ruptured. Once diagnosed a small number of these aneurysms are treatable from an endovascular approach using various embolization devices. These embolization devices include detachable balloons, coils, polymerizing liquids, gels, foams, stents and combinations thereof
The most widely used embolization devices are detachable embolization coils. These coils are generally made from biologically inert platinum alloys. To treat an aneurysm, the coils are navigated to the treatment site under fluoroscopic visualization and carefully positioned within the dome of an aneurysm using sophisticated, expensive delivery systems. Typical procedures require the positioning and deployment of multiple embolization coils which are then packed to a sufficient density as to provide a mechanical impediment to flow impingement on the fragile diseased vessel wall. Some of these bare embolization coil systems have been describe in U.S. Pat. No. 5,108,407 to Geremia, et al., entitled, “Method And Apparatus For Placement Of An Embolic Coil” and U.S. Pat. No. 5,122,136 to Guglielmi, et al., entitled, “Endovascular Electrolytically Detachable Guidewire Tip For The Electroformation Of Thrombus In Arteries, Veins, Aneurysms, Vascular Malformations And Arteriovenous Fistulas.” These patents disclose devices for delivering embolic coils at predetermined positions within vessels of the human body in order to treat aneurysms, or alternatively, to occlude the blood vessel at a particular location. Many of these systems, depending on the particular location and geometry of the aneurysm, have been used to treat aneurysms with various levels of success. One drawback associated with the use of bare embolization coils relates to the inability to adequately pack or fill the aneurysm due to the geometry of the coils which can lead to long term recanalization of the aneurysm with increased risk of rupture.
Some improvements to bare embolization coils have included the incorporation of expandable foams, bioactive materials and hydrogel technology as described in the following U.S. Pat. No. 6,723,108 to Jones, et al., entitled, “Foam Matrix Embolization Device”, U.S. Pat. No. 6,423,085 to Murayama, et al., entitled, “Biodegradable Polymer Coils for Intraluminal Implants” and U.S. Pat. No. 6,238,403 to Greene, et al., entitled, “Filamentous Embolic Device with Expansible Elements.” While some of these improved embolization coils have been moderately successful in preventing or reducing the rupture and re-rupture rate of some aneurysms, the devices have their own drawbacks. For instance, in the case of bioactive coils, the materials eliciting the biological healing response are somewhat difficult to integrate with the coil structure or have mechanical properties incompatible with those of the coil making the devices difficult to accurately position within the aneurysm. In the case of some expandable foam and hydrogel technology, the expansion of the foam or hydrogel is accomplished due to an interaction of the foam or hydrogel with the surrounding blood environment. This expansion may be immediate or time delayed but is generally, at some point, out of the control of the physician. With a time delayed response the physician may find that coils which were initially placed accurately and detached become dislodged during the expansion process leading to subsequent complications.
For many aneurysms, such as wide necked or fusiform aneurysms the geometry is not suitable for coiling alone. To somewhat expand the use of embolization coils in treating some wide necked aneurysms, stent like scaffolds have been developed to provide support for coils. These types of stent like scaffolds for use in the treatment of aneurysms have been described in U.S. Pat. No. 6,605,111 to Bose et al., entitled, “Endovascular Thin Film Devices and Methods for Treating Strokes” and U.S. Pat. No. 6,673,106 to Mitelberg, et al., entitled, “Intravascular Stent Device”. While these stent like devices have broadened the types of aneurysms amenable to embolization therapy, utilization of these devices in conjunction with embolization devices is technically more complex for the physician, may involve more risk to the patient and have a substantial cost increase for the healthcare system.
To further expand the types of aneurysm suitable for interventional radiological treatment, improved stent like devices have been disclosed in U.S. Pat. No. 5,824,053 to Khosravi et al., entitled, “Helical Mesh Endoprosthesis and Method”, U.S. Pat. No. 5,951,599 to McCrory, entitled, “Occlusion System for the Endovascular Treatment of and Aneurysm” and U.S. Pat. No. 6,063,111 to Hieshima et al., entitled, “Stent Aneurysm Treatment System and Method.” When placed across the neck of an aneurysm the proposed stent like devices purport to have a sufficient density through the wall of the device to reduce flow in the aneurysm allowing the aneurysm to clot, while at the same time having a low enough density through the wall to allow small perforator vessels adjacent to the aneurysm to remain patent. Stent devices of this nature while having the potential to reduce treatment costs have not been realized commercially due to the difficulty in manufacturing, reliability in delivering the devices to the treatment site and an inability to properly position the denser portion of the stent device accurately over the neck of the aneurysm.
Another cerebrovascular disease state is ischemia resulting from reduced or blocked arterial blood flow. The arterial blockage may be due to thrombus, plaque, foreign objects or a combination thereof Generally, plaque buildup within the lumen of the vessel, known as atherosclerotic disease, is not generally responsive to thrombolytics or mechanical disruption using guidewires. The approach to the treatment of neurovascular atherosclerotic disease has been to use modified technology developed for the treatment of cardiovascular atherosclerotic disease, such as balloons and stents, to expand the vessel at the site of the lesion to re-establish blood flow. For instance, U.S. Pat. No. 4,768,507 to Fischell et al., entitled, “Intravascular Stent and Percutaneous Insertion Catheter System for the Dilation of an Arterial Stenosis and the Prevention of Arterial Restenosis” discloses a system used for placing a coil spring stent into a vessel for the purposes of enhancing luminal dilation, preventing arterial restenosis and preventing vessel blockage resulting from intimal dissection following balloon and other methods of angioplasty. The coil spring stent is placed into spiral grooves on an insertion catheter. A back groove of the insertion catheter contains the most proximal coil of the coil spring stent which is prevented from springing radially outward by a flange. The coil spring stent is deployed when an outer cylinder is moved proximally allowing the stent to expand. Other stent systems include those disclosed in U.S. Pat. No. 4,512,338 to Balko, et al., entitled, “Process for Restoring Patency to Body Vessels”, U.S. Pat. No. 5,354,309 to Schnepp Pesch et al., entitled, “Apparatus for Widening a Body Cavity” and U.S. Pat. No. 6,833,003 to Jones et al., entitled, “Expandable Stent and Delivery System”. While the aforementioned devices may have the ability to access the cerebrovasculature, they lack sufficient structural coverage of the lesion to achieve the desired patency of the vessel without the use of a balloon device.
In accordance with one aspect of the present invention there is provided a medical device deployment system for depositing a medical device within a body lumen of a mammal. The medical device deployment system includes a medical device, a delivery catheter and an inflation source member. The delivery catheter includes a longitudinally extending balloon member coupled to its distal end which is everted and positioned within the catheter lumen. The medical device is positioned at the distal end of the delivery catheter and disposed within the lumen of the catheter within the everted balloon member.
The balloon member of the delivery catheter is typically formed of a thin walled polymeric tube in which the distal end of the tube has been sealed and the proximal end of the balloon member is coupled to the distal end of the catheter in which the lumen of the catheter is in fluid communication with the interior surface of the balloon. The balloon member is preferably formed of a high strength non-compliant polymeric material such as nylon, polyester and others, however, metallic materials such as thin-film nitinol or other alloys may also be suitable.
The medical device takes the form of a self-expanding structure formed of a resilient material having a first constrained configuration in which the device is compressed and positioned within the lumen of the catheter and a second expanded configuration in which the device is deployed from the catheter lumen and positioned within a vessel adjacent a target site. The medical device may include proximal and distal markers to aid in positioning the device within the vasculature.
The inflation source member is coupled to the proximal end of the catheter and used to apply fluid pressure to the lumen of catheter at a level sufficient to cause the balloon member to extend longitudinally from the catheter lumen, thus deploying the stent. The preferred fluids include liquids such as saline although gases such as carbon dioxide gas may be suitable for some system configurations. The amount of fluid pressure required to inflate the balloon is in part related to the increased friction force between the balloon inner surface and the interior wall of the catheter lumen due to the outward force applied by the constrained stent device. The inflation source member preferably takes the form of a syringe (threaded or non-threaded), however other inflation sources such as a pressurized fluid sources having a valve assembly or a controllable fluid delivery pump are also suitable.
In accordance with one aspect of the present invention there is provided a medical device that takes the form of an occlusion device. The occlusion device is formed of resilient materials and preferably includes a tubular framework and an expandable polymeric material securely positioned within the tubular framework. The tubular framework may take the form of a self-expanding stent like device. The proximal and or distal ends may be flared to ensure good wall apposition and may include configurations such as barbs that aid in anchoring the device at a target site when deployed. The proximal and distal ends of the framework may include markers for visualization under fluoroscopy or MR imaging modalities. The expandable polymeric material preferably takes the form of an expandable foam plug. Alternatively the expandable material may be a swellable hydrogel that is dimensioned to occlude the lumen when deployed at a target site. As can be appreciated the swellable hydrogel may also be foamed. Suitable materials for the expandable polymeric material may include foams and or hydrogels of polyvinyl alcohol (PVA), polyacrylates, electroactive polymers, collagen, alginates, ePTFE, polymer blends or copolymers and shape memory polymers. Typically, the expandable polymeric material of this embodiment of an occlusion device is soft and compliant and generally unsuitable for remaining in position without being secured to the tubular framework. The expandable polymeric material may be secured to the framework using adhesives, thermoforming techniques or mechanical interlock. In one type of mechanical interlocking configuration, the diameter of the expandable polymeric material has a diameter equal to or greater than the diameter of the tubular framework at its distal and proximal ends, while the diameter of the mid portion of the tubular framework may be smaller than the diameter at the ends of the tubular framework. This stricture configuration ensures that the expandable polymeric material is secured within the framework unable to move distally or proximally. Another mechanical interlock configuration includes forming the expandable polymeric material within the tubular framework such the polymeric material encapsulates elements of the tubular framework thereby being secured to the framework.
In accordance with another aspect of the present invention there is provided a medical device deployment system. The medical device deployment system includes a medical device, a delivery catheter and an inflation source member. The delivery catheter includes a longitudinally extending balloon member coupled to its distal end which is everted and positioned within the catheter lumen. The medical device is positioned at the distal end of the delivery catheter and disposed within the lumen of the catheter within the everted balloon member. The delivery catheter further includes a flow restriction member positioned within the catheter lumen proximal to the everted balloon and medical device. The flow restriction member is preferably formed as tubular member having lumen substantially smaller than the lumen of the catheter. The flow restriction member may be formed of a metal, ceramic, polymer or any mixture thereof and have dimensional characteristics that do not significantly impact the ability of the catheter to access target sites within the vasculature. The flow restriction member performs the function of limiting the flow of fluid delivered from the proximal end of the catheter to the everted balloon member during deployment. This flow restriction member allows the balloon member to evert during inflation (while advancing the medical device) in a more controlled manner. As the fluid pressure applied to the lumen of the catheter reaches a sufficient level, the fluid pressure causes the balloon to begin to deploy, subsequently advancing the medical device. Once sufficient pressure is applied, the rate at which the balloon can deploy longitudinally from the catheter is dependent upon the volume of fluid available to inflate the balloon volume. The flow restriction member prevents the balloon member from inflating too rapidly (and uncontrollably deploying the medical device) by reducing the volume of fluid available for inflation thus providing more control over how the medical device is deployed.
In accordance with yet another aspect of the present invention there is provided a medical device that takes the form of a filter device. The filter device is formed of resilient materials and preferably includes a tubular framework body portion and an expandable filter assembly coupled to the body portion. The tubular framework body portion may take the form of a self-expanding stent like device. The proximal and or distal ends may be flared to ensure good wall apposition and may include configurations such as barbs that aid in anchoring the device at a target site when deployed. The proximal and distal ends of the framework body portion may include markers for visualization under fluoroscopy or MR imaging modalities. The expandable filter assembly preferably takes the form of plurality of collapsible filter arm elements coupled to the framework body portion and positioned to span the lumen diameter to capture and or break up emboli.
In accordance with still another aspect of the present invention there is provided a method of implanting a medical device in a body lumen according to an embodiment of the present invention. The method comprises the steps of: positioning a medical device deployment system within a vessel adjacent a target site; applying fluid pressure to the interior deployment lumen of the catheter; extending the balloon member from the catheter lumen longitudinally, thereby allowing a portion of the medical device to be deployed adjacent the target site; retracting the catheter relative to the deployed portion of the medical device; releasing the medical device from the delivery catheter deployment lumen; and releasing the medical device from the balloon member.
In accordance with yet still another aspect of the present invention there is provided a medical device comprising a biocompatible material. Suitable resilient materials include metal alloys such as Nitinol(NiTi), titanium, chromium alloy, stainless steel. Additional materials include polymers such as polyolefins, polyimides, polyamides, fluoropolymers, polyetheretherketone(PEEK), cross-linked PVA hydrogel, polytetrafluoroethylene (PTFE), expanded polytetrafluoroethylene (ePTFE), porous high density polyethylene (HDPE), polyurethane, and polyethylene terephthalate, or biodegradable materials such as polylactide polymers and polyglycolide polymers or copolymers thereof and shape memory polymers. The medical device may comprise numerous materials depending on the intended function of the device. These materials may be formed into desired shapes or attached to the device by a variety of methods which are appropriate to the materials being utilized such as laser cutting, injection molding, spray coating and casting.
In accordance with another aspect of the present invention there is provided a medical device having a coating formed of a biocompatible, bioerodible and biodegradable synthetic material. The coating may further comprise one or more pharmaceutical substances or drug compositions for delivering to the tissues adjacent to the site of implantation, and one or more ligands, such as peptides which bind to cell surface receptors, small and/or large molecules, and/or antibodies or combinations thereof for capturing and immobilizing, in particular progenitor endothelial cells on the blood contacting surface of the medical device.
Methods and systems for implanting a medical device in a desired area of the body are herein described.
Preferably, support framework 120 comprises a biocompatible resilient material. Suitable resilient materials include metal alloys such as nitinol, titanium, stainless steel. Additional suitable materials include polymers such as polyimides, polyamides, fluoropolymers, polyetheretherketone(PEEK) and shape memory polymers. As can be appreciated, embodiments of support framework 120 may comprise bioabsorbable and or bioerodible materials such as polycaprolactone (PCL), polyglycolic acid (PGA), polydioxanone (PDO) and combinations thereof to allow the framework to illicit a biological healing response and or to deliver pharmacological or therapeutic compounds over time. These materials may be formed into desired shapes by a variety of methods which are appropriate to the materials being utilized such as laser cutting, thermal heat treating, vacuum deposition, electro-deposition, vapor deposition, chemical etching, photo-chemical etching, electro etching, stamping, injection molding, casting, coating or any combination thereof.
Occlusion member 125 of occlusion device 80 preferably takes the form of an expandable foam plug dimensioned to occlude a desired lumen. Alternatively, occlusion member 125 may take the form of an un-foamed swellable hydrogel that is dimensioned to occlude the lumen when deployed at a target site. Suitable materials for occlusion member 125 include foams and or hydrogels of polyvinyl alcohol (PVA), polyacrylates, electroactive polymers, collagen, alginates, extracellular matrices, ePTFE, polymer blends or copolymers and shape memory polymers. Occlusion member 125 is generally soft and compliant and does not exert enough outward force to remain positioned at target site within the vasculature under flow conditions without being secured to framework 120. Occlusion member 125 may be secured to framework 120 using adhesives, thermoforming techniques or mechanical interlock configurations.
Typically, occlusion device 80 has as many markers as needed to accurately position the device depending on the particular anatomical location desired. As illustrated in
Preferably, support body 310 and filter portion 315 comprise biocompatible resilient materials. Suitable resilient materials include metal alloys such as nitinol, titanium, stainless steel. Additional suitable materials include polymers such as polyimides, polyamides, fluoropolymers, polyetheretherketone(PEEK) and shape memory polymers. As can be appreciated, embodiments of support framework 120 may comprise bioabsorbable and or bioerodible materials such as polycaprolactone (PCL), polyglycolic acid (PGA), polydioxanone (PDO) and combinations thereof to allow the support body to elicit a biological healing response and or deliver pharmacological or therapeutic compounds over time. These materials may be formed into desired shapes by a variety of methods which are appropriate to the materials being utilized such as laser cutting, thermal heat treating, vacuum deposition, electro -deposition, vapor deposition, chemical etching, photo-chemical etching, electro etching, stamping, injection molding, casting, coating or any combination thereof.
A specific filter device design is heavily dependant upon the clinical application for the device and may include materials or coatings to improve the biocompatibility of the device such as coatings that include ligands adapted to capture endothelial progenitor cells within the vasculature. Additionally, the filter device may include a filter portion formed of bio-erodible or bio-absorbable materials and or materials suitable for the delivery of pharmacological or therapeutic agents adapted to reduce the formation of clots and or encourage the dissolution of thrombus or clots encountered during the intravascular flow of blood. Materials and coating process technology suitable for application to the present invention are described in U.S. Patent Application Publication No: 20070128723 A1 to Cottone et al., entitled, “Progenitor Endothelial Cell Capturing with a Drug Eluting Implantable Medical Device” herein incorporated by reference in its entirety.
Typically, filter device 300 has as many markers as needed to accurately position the device depending on the particular anatomical location desired. As illustrated in
Novel devices, systems and methods have been disclosed to deploy medical devices within body lumens of a mammal. Although preferred embodiments of the invention have been described, it should be understood that various modifications including the substitution of elements or components which perform substantially the same function in the same way to achieve substantially the same result may be made by those skilled in the art without departing from the scope of the claims which follow.
This application claims the benefit of U.S. Provisional Application No. 61/501,742 filed Jun. 27, 2011, U.S. Provisional Application No. 61/501,745 filed Jun. 27, 2011 U.S. Provisional Application No. 61/501,746 filed Jun. 27, 2011 and U.S. Provisional Application No. 61/501,747 filed Jun. 27, 2011 all of which are hereby incorporated by reference herein in their entireties.
| Number | Date | Country | |
|---|---|---|---|
| 61501742 | Jun 2011 | US | |
| 61501745 | Jun 2011 | US | |
| 61501746 | Jun 2011 | US | |
| 61501747 | Jun 2011 | US |
