Patent Grant
10987208
The present disclosure relates to a medical device for insertion into a body vessel to treat vessel disease and malformations.
Vascular diseases include aneurysms causing hemorrhage, atherosclerosis causing the occlusion of blood vessels, vascular malformations and tumors. Vessel occlusion and rupture of an aneurysm within the brain are causes of stroke. Aneurysms fed by intracranial arteries can grow within the brain to a point where their mass and size alone, without rupture, can cause a stroke or the symptoms of stroke, requiring surgery for removal of the aneurysms or other clinical intervention. Additionally, these expanding vessels can exert pressure on surrounding nerves which can lead to conditions such as diplopia, ptosis, pounding headaches, delirium, and hemi-paresis, just to name a few.
Occlusion of coronary arteries, for example, is a common cause of heart attack. Diseased and obstructed coronary arteries can restrict the flow of blood in the heart and cause tissue ischemia and necrosis. While the exact etiology of sclerotic cardiovascular disease is still in question, the treatment of narrowed coronary arteries is more defined. Surgical construction of coronary artery bypass grafts (CABG) is often the method of choice when there are several diseased segments in one or multiple arteries. Conventional open-heart surgery is, of course, very invasive and traumatic for patients undergoing such treatment. Therefore, alternative, less traumatic methods are highly desirable.
One of the alternative methods is balloon angioplasty, a technique in which a folded balloon is inserted into a stenosis, which occludes or partially occludes an artery. The balloon is inflated to open the occluded artery, restoring or otherwise improving blood flow. Another alternative method is atherectomy that is a technique in which occlusive atheromas are cut from the inner surface of the arteries. Both methods suffer from reocclusion with a certain percentage of patients.
A recent preferred therapy for vascular occlusions is placement of an expandable metal wire-frame within the occluded region of blood vessel, to maintain patency after an occlusion treatment. The implant is delivered to the desired location within a vascular system by a delivery means, usually a catheter. These interventional procedures avoid the various complications of surgery, including heart-lung by-pass, opening the chest, and general anesthesia.
When inserted and deployed in a vessel, duct or tract (hereinafter “vessel”) of the body, for example, a coronary artery after dilatation of the artery by balloon angioplasty, an implant acts as a prosthesis to maintain the vessel open. The implant usually has an open-ended tubular form with interconnected struts as its sidewall to enable its expansion from a first outside diameter, which is sufficiently small to allow the implant to traverse the vessel to reach a site where it is to be deployed, to a second outside diameter sufficiently large enough to engage the inner lining of the vessel for retention at the site. An implant is typically delivered in an unexpanded state to a desired location in a body lumen and then expanded. The implant is expanded via the use of a mechanical device such as a balloon, or the implant may be self-expanding.
Usually a suitable implant for successful interventional placement should possess features of relatively non-allergenic reaction and other biocompatibility, sufficient radiopacity to be visualized with X-ray, freedom from distortion when using magnetic resonance imaging (MRI), sufficient flexibility to be intraluminally advanced to an implantation site, strong resistance to vessel recoil, and sufficient thinness to minimize obstruction to flow of blood (or other fluid or material in vessels other than the cardiovascular system).
Implantable medical devices have been utilized for delivery of drugs or other agents for different clinical applications. Typically, the agents are coated onto the surfaces of the implantable devices or mixed within polymeric materials that are coated onto the surfaces of the implants. Current devices experience uncontrolled release of agent, have limitations on types of agents used, and may comprise a bulky agent delivery mechanism.
There is a need for systems, methods and devices that provide improved treatment of blood vessels, including improved treatment of neurovascular aneurysms.
The subject technology is illustrated, for example, according to various aspects described below. These are provided as examples and do not limit the subject technology. It is noted that any of the aspects below may be combined in any combination.
According to an embodiment of the present disclosure, a system for treating a diseased vessel comprises an expandable device configured to radially expand from a first position to a second position; a membrane expandable in response to the expansion of the expandable device; and a delivery device configured to position the expandable device such that the exterior surface of the expandable device engages with the inner surface of the vessel and maintains a fluid pathway through said vessel. The system can be used to treat one or more diseased vessels with a diameter ranging between 1.25 mm and 30 mm.
The system may be used to treat various types of aneurysms, including but not limited to: intracranial; fusiform; berry; saccular; carotid-cavernous fistula; and combinations of these. Additionally, the system can be used to treat aneurysms of various sizes, including but not limited to: regular sized aneurysms; large or giant neck aneurysms; wideneck aneurysms; aneurysms arising from a parent vessel wherein the parent vessel comprises a diameter of approximately 2.0 mm to 5.0 mm; and combinations of these. Further, the system can be used to treat a bifurcation and/or trifurcation intracranial aneurysm.
The system is constructed and arranged to near immediately and near completely occlude an aneurysm while maintaining patency in crossed side branches. The system is constructed and arranged to achieve remodeling of a diseased vessel that results in improved hemodynamics within or proximate to the diseased vessel as well as correct the unfavorable hemodynamics that may have caused the aneurysm. The system is constructed and arranged to promote healing, avoid causing a significant inflammatory response, and avoid creating necrotic tissue. In some embodiments, the system achieves delivery of the expandable device in a one-step procedure. In some embodiments, the system may be disposed after a single use.
Embodiments of the system of the present disclosure can be used in other applications including but not limited to: to treat ischemia; to treat a neurovascular disease such as a hemorrhagic aneurysm, atherosclerosis, emboli such as ruptured vulnerable plaque emboli, carotid artery occlusion, and arterio-venous malformations; to treat peripheral aneurysms such as popliteal, renal, and abdominal aortic; to treat myocardial infarction; to treat an arterio-venous fistula; and combinations of these.
In some embodiments, the expandable device is configured to be plastically deformed during a radial expansion from the first position to the second position. In some embodiments, the delivery device comprises a retractable sheath configured to maintain the expandable device in the first position prior to retraction, and to release the expandable device to the second position after retraction, where the expandable device is resiliently biased in the second position. In some embodiments, the expandable device comprises at least two portions wherein the first portion is plastically deformable during the radial expansion from the first position to the second position, and the second portion is resiliently biased in the second position. In some embodiments, the expandable device may expand to a diameter of a vessel in its healthy state plus 0.5 mm, for example 2.0 mm to 5.0 mm.
The expandable device may be constructed and arranged to cover the surface of an aneurysm such that the aneurysm can be treated with a single expandable device, for example, the aneurysm coverage ranges from 65% to 95%.
The expandable device may comprise a frame with a generally tubular structure having an inner surface and an exterior surface, where the exterior surface comprises a plurality of interconnected struts having interstitial spaces therebetween. The frame may be inserted into a vessel and implanted therein. The frame may include at least six points, for example seven points. The frame may comprise a material selected from the group consisting of: stainless steel and/or Nitinol, such as 316L stainless steel; a polymer; and combinations of these. The frame may comprise a coating, for example a radiopaque coating, such as a gold radiopaque coating. The frame may comprise wires having welded ends that are arranged in a braid. The frame may comprise a rigidity sufficient to cause straightening of the diseased vessel as the expandable device is expanded. After expansion of the expandable device, the frame may be reshaped and/or further expanded via a post-dilatation balloon catheter to prevent leaks around the expandable device, for example when the frame comprises at least one plastically deformable portion. In some embodiments, the proximal portion of the expandable device is reshaped and/or further expanded by the post dilatation balloon prior to the distal portion of the expandable device.
The exterior surface of the frame may be encapsulated, completely or partially, for example, by a polymer material configured for atraumatic placement in a vessel. Typically, the polymer coating comprises a soft, super-elastic, biocompliant, ultra-thin material selected from the group consisting of: fluoropolymers; polyimide; silicone; polyurethanes; polyurethane ether; polyurethane ester; polyurethane polycarbonate; polyurethane urea; copolymers of these; and combinations of these. Additionally or alternatively, the frame may include a lubricous coating. The interior surface of the frame may comprise a smooth surface such that micro-turbulence is minimized.
The frame may include at least two wires, typically eight to thirty-eight wires, and more typically eight to fourteen wires. Wire diameter may range from 0.0005″ to 0.004″, for example 0.003″. Wire material may be selected from the group consisting of: metal; shape memory alloys such as Nitinol; shape memory polymers; and combinations of these. In some embodiments, the wires may comprise a composite material, for example, each wire includes an outer tube an inner core that are fused together, where the inner core comprises a radiopaque material, and the outer core comprises a deformation resistance material, or vice versa. Other inner and outer core materials include but are not limited to: metal; shape memory alloy; shape memory polymer; Platinum/Tungsten; Cobalt Chromium; and combinations of these.
The at least two wires may comprise a weave configuration, for example a braided configuration. The braid configuration can be achieved via a one-over-one-under method; a one-over-two-under method; and/or a two-over-two-under method. The braid configuration creates a frame with a diamond cell, where the diamond cell comprises a width ranging from 0.00 mm to 0.26 mm, or ranging from 0.15 mm to 0.053 mm, e.g. 0.13 mm.
In one embodiment, the at least two wires comprise a first wire, a second wire, and a braid angle therebetween. The braid angle may range from 1° to 179°. In some embodiments, the braid angle ranges from 80° to 145°. In some embodiments, the braid angle approximates 90°. The braid angle may be uniform or it may vary about a circumference and a length of the expandable device.
The expandable device may comprise a length of 7.0 mm to 40.0 mm, and can be shortened via a cutting procedure. In some embodiments, the length of the expandable device can comprise a length of the aneurysm neck to be treated plus an additional 15 mm, for example a length ranging from 14 mm to 26 mm. When expanded, the expandable device may comprise an outer diameter ranging from 1.5 mm to 5.0 mm, and said device is constructed and arranged to maintain a relatively constant diameter under systolic pressures after expansion. In some cases, changes in vessel diameter may cause limited diameter changes to the expandable device.
The expandable device may comprise a polymer material, such as a polymer selected from the group consisting of: a polyurethane; a polyurethane ether; a polyurethane ester; a polyurethane polycarbonate; a polyurethane urea; copolymers of these; and combinations of these.
The expandable device may be pre-mounted onto the delivery device. The expandable device can be loaded onto a delivery device comprising a micro-catheter and a delivery wire. In some embodiments, the self-expandable device can be retracted into the micro-catheter after 90% or less of the self-expandable device is advanced from the distal end of the micro-catheter.
The expandable device may comprise a coating, for example, a hydrophilic coating. The system may further include a second expandable device configured to expand from a first position to a second position. In some embodiments, the first expandable device comprises a self-expandable device and the second expandable device comprises a balloon expandable device, for example where the first device provides adequate coverage in a vessel, and the second device provides adequate apposition between the first and second expandable devices and the vessel. The first and second expandable devices may be similar or dissimilar in construction, e.g. materials, braid configuration, coatings, radiopacity, size and the like. The first expandable device may be implanted, and the second expandable device may be implanted in approximately the same position. The first and second devices may be implanted such that they overlap one another, having any amount of overlap, for example where the overlapping portion is proximate an aneurysm. The first and second devices may be implanted in a tandem configuration.
The expandable device may include at least one marker, including but not limited to: radiopaque markers such as markers that can be viewed with X-ray or fluoroscopy; visible markers such as markers that can be viewed with a visible intraluminal camera; infrared markers such as markers that can be viewed with an infrared intraluminal camera; ultrasound markers such as markers that can be viewed with external ultrasound or intravascular ultrasound; magnetic markers such as markers that can be viewed with MRI; and combinations of these. In some embodiments, a first marker can be positioned on a distal portion of the frame, and a second marker can be positioned on a proximal portion of the frame. The proximal and/or distal portion of the frame may include at least one ring where the at least one ring includes at least two teeth constructed and arranged to secure at least one marker within the at least one ring. The at least one ring may be coated with a radiopaque material, for example a gold material.
The system can include a membrane. The membrane may include a polymer such as BioSpan®2F which can be described as a segmented polyurethane including a polytetramethyleneoxide-based aromatic polyurethane urea with mixed aliphatic and cycloaliphatic diamine chain extender. The membrane may include a polymer such as BioSpan® F which can be described as a segmented polyurethane with fluorocarbon as surface modifying endgroups. Alternatively or additionally, the membrane may comprise a polymer material selected from the group consisting of: a fluoropolymers; a polyimide; a silicone; an alkoxy-silicone; a polyurethane; a polyurethane ether; a polyurethane ester; a polyurethane polycarbonate; a polyurethane urea; copolymers of these; and combinations of these. Additional examples of a polymer material include: a biodegradable polylactide; a polyether; a polyethylene glycol (biostable); a poly(DL-lactide-co-caprolactone) (PLC); a poly(DL-lactide-co-glycolide) (PLGA) (typically biodegradable); a polyether of varying composition and molecular weight; a polyester; a polycarbonate diol; a copolymer of these; and combinations of these. In some embodiments, the polymer material has a molecular weight ranging from MW 100-2000. The polymer can comprise at least one chain extender comprising one or more diolsor multi-functional groups comprising one or more bioactive surface modifying groups. Non-limiting examples of chain extenders include: methylene diisocyanate; toluene diisocyanate; hexamethylenediisocyanate; diisocyanates; alkyl-triols such as glycerol and increasing molecular weight analogs; triamines; orthoformic acid; phosphates such as Inositol trisphosphate; Calcitriol; cyclic polyols (Cyclitols); Ciceritol; short chain functionalized amino acids; polyketides characterized by three hydroxyl groups such as Tautomycin; lipidoid C12-200; fluoroalkane; fluoroalkanols; and combinations of these. In some embodiments, the polymer can comprise at least one end group that can be functionalized prior to incorporation into the polymer. In some embodiments, the polymer can comprise a reactively functionalized polymer including: an allyl-alkyl hydroxide or amine; a siloxy-containing reactive functionality; a poly methyoxy or polyethyoxy low molecular weight complex; and combinations of these. The polymers described herein can be configured as nanoparticles; self encapsulating particles (e.g. for multiple drug delivery systems); coatings for stents, catheters, or other medical devices; and combinations of these.
The polymer can comprise one or more radio-lucent or radio-opaque materials selected from the group consisting of: a halogen such as bromine or iodine; a ceramic; a metal such as stainless steel, gold, silver or platinum; and combinations of these. The polymer can be embedded with a gel and/or gels-sol comprising the one or more radio-lucent or radio-opaque materials.
The membrane may include at least a biodegradable portion, for example a first portion of the membrane may biodegrade and a second portion may be relatively stable after implantation over time. Alternatively, the entire membrane may comprise a biodegradable material. The membrane may completely surround an exterior surface of the expandable device, or it may cover at least a portion of the device, for example a circumferential portion. The membrane may comprise a plurality of polymeric strips, such 0.075 mm wide strips positioned less than 100 microns apart. For example, the strips may be between about 0.050 mm and about 0.100 mm wide. By further example, the strips may be between about 50 microns and about 200 microns apart. The membrane may comprise a woven mesh.
In some embodiments, the expandable device can comprise one or more drugs, reagents and/or other agents. For example, one or more drugs and/or other agents can be coated onto a surface of the expandable device, mixed, embedded, or covalently bonded with polymeric materials that are coated onto the surfaces of the expandable device. In some embodiments, one or more drugs and/or other agents can be loaded into a suitable polymer vehicle that can then be bonded to the polymeric coating, e.g. a membrane, on the expandable device. In some embodiments, the membrane can comprise the polymer comprising one or more drugs and/or other agents. In some embodiments, the polymer comprises a dendrimer-type polymer which can be described as a macromolecule, where the dendrimer-type polymer can comprise one or more drugs and/or other agents configured to diffuse from the polymer over a period of time, for example a time period matching the time course of restenosis, such as at least four weeks and up to one year. As used herein, a “dendrimer-type polymer” comprises dendrimers and/or dendrons. As used herein, “dendrimer” means a repetitively branched molecule, including arborols and cascade molecules. A dendrimer may be symmetric around a core and may adopt a spherical three-dimensional morphology. As used herein, “dendron” means a molecule comprising branches from a single chemically addressable focal point.
Non-limiting examples of drugs and/or other agents include: anti-proliferative agents; anti-inflammatory agents; cell regeneration promoting agents; nanoparticles; drug-eluting nanoparticles; nanoparticle gels; and/or restenosis inhibiting agents. The polymer coating can be configured for controlled and long-term drug and/or other agent delivery to the vessel.
The membrane comprises a thickness such that turbulence into side branches in minimized, for example, the membrane may comprise a thickness ranging from 0.0005″ (10 um) to 0.005″, for example 0.001″. In some embodiments, the membrane thickness decreases post-expansion of the expandable device, for example to a thickness ranging from 0.0005″ (10 um) to 0.002″. The membrane thickness can vary along the length and/or along the circumference of the expandable device.
The membrane may comprise a non-porous and non-permeable material such that blood circulation to the aneurysm is prevented. Additionally or alternatively, the membrane may comprise at least a porous portion comprising pores. The pores may be uniform across the membrane or portion of the membrane, for example, the pores may uniformly sized and spaced. Preferably, the pores are sized and spaced such that blood is not throttled into the aneurysm. The pores may comprise a diameter between 20 microns and 200 microns. The pores may comprise a diameter between 50 microns and 120 microns. The pores may comprise a diameter between 80 microns and 100 microns. Conversely, the pores may be non-uniform across the membrane or portion of the membrane, where non-uniformity can be achieved by varying at least one of the pore size; distance between adjacent pores; or pore shape. For example, the pores may have a smaller diameter at a mid portion of the expandable device and a larger diameter at the proximal and distal portions of the expandable device.
The pores may be drilled, for example via a laser, such that the pores expand from an initial diameter to a final diameter upon expansion of the expandable device. For example, the initial diameter of the pores can range form 20 microns to 50 microns, and the final diameter can range from 50 microns to 120 microns, or 80 microns to 100 microns. Additionally or alternatively, the pores may be drilled to a final diameter, i.e. diameter remains relatively constant upon expansion of the expandable device. For example, the diameter of the pores can range from 50 microns to 120 microns, or 80 microns to 100 microns. In some embodiments, pore size can vary, for example, the pores may have a smaller diameter at a mid portion of the expandable device and a larger diameter at the proximal and distal portions of the expandable device. The pores may be drilled in a geometric shape selected from the group consisting of: circular; elliptical; rectangular; trapezoidal; and combinations of these. The various geometric shapes comprise a major axis, and the length of the major axis may be approximately 50 microns to 120 microns, or 80 microns to 100 microns. Similar to the size of the pores, the shape of the pores may transition from a first shape to a second shape upon expansion of the expandable device, for example a pore may be drilled to comprise a circular shape and expand to comprise an elliptical shape. One or more membrane pores can be drilled so there is little to no contact with the struts of the expandable device.
The membrane comprises an inner surface, where the inner surface may comprise a smooth surface such that micro-turbulence is prevented.
The membrane may be expandable up to 1000%. The membrane may be expandable up to 140%.
The system includes a delivery device comprising a catheter comprising at least one shaft, a guidewire lumen and an inflation lumen, where the catheter includes a distal portion with a profile, for example a profile between 0.045″ to 0.060″. The guidewire lumen may comprise an entry port positioned 5.5 mm to 6.5 mm from the distal tip of the catheter, and said lumen may be positioned at the geometric center of the catheter shaft. The inflation lumen can be used for inflating a balloon and/or transporting a fluid. The delivery device may comprise two shafts, a first shaft and a second shaft. The first shaft may surround the guidewire lumen and may comprise at least two layers, for example a co-extrusion of Pebax™ 55D and HDPE, or a co-extrusion of Pebax™ 55D and PTFE, typically materials with a durometer ranging from 35D to 72D, more typically 55D. The second shaft may surround the inflation lumen.
The first and second shafts may each comprise a coil, a first and a second coil, that surrounds the guidewire and inflation lumens, respectively. The first coil may reside between the two co-extruded layers of the first shaft. Including the first coil, the first shaft may comprise a durometer ranging from 35D to 72D, typically 55D. Including the second coil, the second shaft may comprise a durometer ranging from 40D to 72D, typically 62D. The first and/or second coil may comprise stainless steel and/or Nitinol, for example 304V stainless steel. The first and second coils comprise a width, a thickness and a pitch. Coil width typically ranges from 0.001″ to 0.004″, more typically 0.00225″. Coil thickness typical ranges from 0.0005″ to 0.002″, more typically 0.008″. Coil pitch typically ranges from 0.004″ to 0.012″, more typically 0.0058″.
The second shaft, having a distal end and a proximal end, can comprise a length such that the second shaft distal end terminates proximal to an inflatable element. For example, where a proximal end of the inflatable element is bonded to the first shaft via a proximal balloon bond, the second shaft distal end is flush with the proximal balloon bond. In another embodiment, the second shaft distal end can extend distal to the inflatable element. For example, where a distal end of the inflatable element is bonded to the first shaft via a distal balloon bond, the second shaft distal end is flush with the distal balloon bond. In this embodiment, the second shaft distal end can be bonded or not bonded to the distal balloon bond. In yet another embodiment, the second shaft distal end can terminate proximal to the distal balloon bond, for example approximately 1 mm proximal to the distal balloon bond. In the cases where the second shaft extends through the inflatable element, the second shaft can comprise at least one hole to assist in inflation and deflation of the inflatable element. The at least one hole can comprise a diameter ranging from approximately 0.005″ to 0.025″, or ranging from approximately 0.010″ to 0.015″. In some embodiments the shaft comprises one to twenty holes. In some embodiments, the second shaft comprises five to ten holes. The second shaft can comprise two or more holes that can be arranged uniformly or non-uniformly along the second shaft, for example holes can comprise similar or dissimilar size and spacing.
The delivery device may comprise a working length of at least 140 cm, for example greater than or equal to 145 cm.
The delivery device may comprise a coating, including but not limited to: a hydrophilic coating; a lubricous coating; and combinations of these.
The delivery device may comprise a guidewire rapid exchange device. The delivery device may comprise a co-axial design, comprising co-axial shafts.
The delivery device comprises a distal segment and a proximal portion, and the distal segment may be more flexible than said proximal portion. The distal segment may be approximately 9 mm in length.
The delivery device may include at least one marker, for example a marker positioned on a distal portion of the delivery device. The at least one marker comprises a marker selected from the group consisting of: radiopaque markers such as markers that can be viewed with X-ray or fluoroscopy; visible markers such as markers that can be viewed with a visible intraluminal camera; infrared markers such as markers that can be viewed with an infrared intraluminal camera; ultrasound markers such as markers that can be viewed with external ultrasound or intravascular ultrasound; magnetic markers such as markers that can be viewed with MRI; and combinations of these.
The delivery device may include an inflatable element configured to expand the expandable device from the first position to the second position. The inflatable element may be attached to the distal end of the shaft such that the inflatable element extends approximately 1 mm to 3 mm past the distal end of the shaft. The inflatable element may expand from a first position to a second position at an opening pressure and a rated burst pressure such that the second position comprises a controlled diameter, for example a diameter of 2.0 mm to 0.0 mm. The opening pressure may range from 3.5 atm to 6 atm, and the rated burst pressure may range from 10 atm to 14 atm.
The inflatable element may comprise at least one marker, for example a distal marker and a proximal marker. The spacing between the distal and proximal marker may depend on the size on the expandable device. The marker spacing for a short expandable device, e.g. 15 mm long, may be approximately 18 mm, and at least approximately 17.5 mm. The marker spacing for a moderate expandable device, e.g. 20 mm long, may be approximately 23.5 mm, and at least approximately 23 mm. The marker spacing for a long expandable device, e.g. 25 mm long, may be approximately 28.5 mm, and at least approximately 28 mm. The marker spacing for an extra-long expandable device, e.g. 30 mm long, may be approximately 33.5 mm, and at least approximately 33 mm.
The inflatable element may comprise a proximal portion, a mid portion, and a distal portion, where the proximal and distal portions are configured to be expanded such that the outer diameter of the proximal and distal portions is greater than that of the mid portion. A tubular conduit, e.g. a Polyimide conduit, a reinforced PTFE conduit, or a polished stainless steel conduit, can be placed around the proximal and/or distal portions such as to define the desired outer diameter of said portions. Alternatively or additionally, a similarly constructed tubular conduit can be placed around the expandable device to prevent expansion of said device during the expansion of the proximal and/or distal portions of the inflatable element.
The inflatable element may comprise a balloon, for example a balloon having at least one fold where the at least one fold is oriented such that the balloon refolds by torqueing the delivery device in a particular direction. The balloon can be configured as a 6-fold balloon; a 5-fold balloon; a 3-fold balloon; or a spiral-fold balloon. The balloon can comprise a material selected from the group consisting of: irradiated polyethylene; polyethylene terephthalate; polyvinylchloride; nylon such as Nylon 12, L2140, L25, L2125, and L2101; copolymer nylon such as Pebax™; and combinations of these. The balloon can comprise a distal taper length and/or a proximal taper length, e.g. 1.5 mm to 5 mm.
The system may further comprise a post-dilatation balloon configured to eliminate a false lumen between a vessel wall and the expandable device. In some embodiments, the post-dilatation balloon comprises a shaft comprising an inflation lumen constructed and arranged similarly to the second shaft of the delivery device, as has been described herein.
The system may further comprise a catheter configured to introduce the delivery device including the expandable device in a vessel, for example a 6F guide catheter.
The system may further comprise a guidewire, for example a 0.014″ guidewire.
The system may further comprise a tubular member, for example a shaped mandrel having a curved portion and a looped proximal end. The curved portion may comprise a 45° bend. The shaped mandrel may comprise a radius ranging from 0.29″ to 0.33″, e.g. 0.315″. The shaped mandrel may comprise an outer diameter ranging from 0.01″ to 0.02″, e.g. 0.015″. The shaped mandrel may comprise a length ranging from 19.0″ to 20.0″, e.g. 19.5″.
According to another aspect of the present disclosure, a method for treating a diseased vessel comprises accessing a target vessel via a delivery device and expanding an expandable device from a first position to a second position radially outward such that an exterior surface of the expandable device engages with an inner surface of the vessel so as to maintain a fluid pathway though the vessel, where the delivery device is configured to position the expandable device, and where the expandable device comprises a membrane expandable from a first position to a second position in response to the expansion of the expandable device.
The expandable device may be expanded via an inflatable element. The inflatable element may be attached to the distal end of the shaft such that the inflatable element extends approximately 1 mm to 3 mm past the distal end of the shaft. The inflatable element may expand from a first position to a second position at an opening pressure and a rated burst pressure such that the second position comprises a controlled diameter, for example a diameter of 2.0 mm to 5.0 mm. The opening pressures may range from 3.5 atm to 6 atm, and the rated burst pressure may range from 10 atm to 14 atm.
The inflatable element may comprise a balloon, for example a balloon having at least one fold where the at least one fold is oriented such that the balloon refolds by torqueing the delivery device in a particular direction. The balloon can be configured as a 6-fold balloon; a 5-fold balloon; a 3-fold balloon; or a spiral-fold balloon. The balloon can comprise a material selected from the group consisting of: irradiated polyethylene; polyethylene terephthalate; polyvinylchloride; nylon such as Nylon 12, L2140, L25, L2125, and L2101; copolymer nylon such as Pebax™; and combinations of these.
To prevent deployment of the expandable device prior to reaching the target vessel, the method may further comprise expanding a proximal portion and a distal portion of the inflatable element, where the proximal and distal portions are configured to be expanded such that the outer diameter of the proximal and distal portions is greater than that of the mid portion. A tubular conduit, e.g. a Polyimide conduit, a reinforced PTFE conduit, or a polished stainless steel conduit, can be placed around the proximal and/or distal portions such as to define the desired outer diameter of said portions. Alternatively or additionally, a similarly constructed tubular conduit can be placed around the expandable device to prevent expansion of said device during the expansion of the proximal and/or distal portions of the inflatable element.
The expansion of the proximal and/or distal portion of the inflatable element may be via thermal energy. In some embodiments, the expansion occurs via a cold process, for example, via the introduction of pressurized Nitrogen. In some embodiments, the expansion occurs via the introduction of heat for a duration of time. For example, the inflatable element can be placed in an over set to 50° C. to 70° C. for a duration of 30 seconds to 15 minutes, or the inflatable element can be placed an over set to 55° C. to 65° C. for a duration of 5 minutes to 10 minutes. In the heat induced method, pressurized Nitrogen may be added to the oven, for example at a pressure ranging from 5 psi to 60 psi, or at a pressure ranging from 10 psi to 50 psi. Upon reaching the desired location within the vessel, the inflatable element may be further inflated such that the outer diameter of the inflatable element approximately matches an inner diameter of the expandable element in preparation for deployment of the expandable device.
The expandable device may be self-expandable. In some embodiments, the self-expandable device is expanded via a delivery device comprising a retractable sheath. In some embodiments, the self-expandable device is expanded by movement of a wire, such that the device is deployed from a micro-catheter.
The expandable device may comprise both balloon expandable and self-expanding portions.
The method further comprises inserting the expandable device into the vessel, where the expandable device comprises an exterior surface and an inner surface. The exterior surface may be smooth such that insertion into the vessel is atraumatic and micro-turbulence is prevented or minimized. This can be achieved via a coating, for example a membrane. The membrane may be comprised of a polymer and/or lubricous materials. Similarly, the inner surface may be smooth such that frictional surface micro-turbulence is prevented or minimized. The expandable device may straighten the vessel after said device is expanded from the first position to the second position.
The method may further comprise expanding the expandable device such that the expanded diameter matches that of a healthy vessel plus 0.5 mm, for example 2.0 mm to 5.0 mm. In some embodiments, the expandable device can be over-expanded such that the device inner diameter matches that of the vessel inner diameter.
The method may further comprise maintaining a relatively constant diameter of the expandable device under systolic pressures after expansion.
The method may further comprise visualizing the delivery device and/or the expandable device, for example using a marker such as a radiopaque marker. Various imaging means can include MRI, Dyna CT, Angio CT, angiography or fluoroscopy. Said visualization can be used to confirm the position of the delivery deice and/or the expandable device before, during and/or after the expansion of the expandable device.
The method may further comprise delivering one or more drugs, reagents and/or other agents to the vessel. For example, one or more drugs and/or other agents can be coated onto a surface of the expandable device, mixed, embedded, or covalently bonded with polymeric materials that are coated onto the surfaces of the expandable device. In some embodiments, one or more drugs and/or other agents can be loaded into a suitable polymer vehicle that can then be bonded to the polymeric coating, e.g. a membrane, on the expandable device. In some embodiments, the membrane can comprise the polymer comprising one or more drugs and/or other agents. In some embodiments, the polymer comprises a dendrimer-type polymer which can be described as a macromolecule, where the dendrimer-type polymer can comprise one or more drugs and/or other agents configured to diffuse from the polymer over a period of time, for example a time period matching the time course of restenosis, such as at least four weeks and up to one year. Non-limiting examples of drugs and/or other agents include: anti-proliferative agents; anti-inflammatory agents; cell regeneration promoting agents; nanoparticles; drug-eluting nanoparticles; nanoparticle gels; and/or restenosis inhibiting agents. The polymer coating can be configured for controlled and long-term drug and/or other agent delivery to the vessel.
The method may further comprise molding the expandable device via a post-dilatation balloon post-expansion from the first position to the second position such that no leak is observed, i.e. space between the expandable device and the vessel is reduced or eliminated.
Multiple steps may be performed prior to the delivery of the implantable device, for example air may be purged from the delivery device. An access site may be prepared, where the access site can be selected from the group consisting of: femoral artery; radial artery; and brachial artery. An inflatable element may be attached to the delivery device. The delivery device may be tracked over a tubular member, for example a shaped mandrel such as to improve tracking of the delivery device. A guidewire may be positioned in a target vessel such that the delivery device can be loaded onto a proximal end of the guidewire and advanced over the guidewire to a vessel.
Subsequent to implantation of the expandable device, the inflatable element can be deflated, and the delivery device can be removed from the vessel.
Additional features and advantages of the subject technology will be set forth in the description below, and in part will be apparent from the description, or may be learned by practice of the subject technology. The advantages of the subject technology will be realized and attained by the structure particularly pointed out in the written description and claims hereof as well as the appended drawings.
It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory and are intended to provide further explanation of the subject technology as claimed.
The accompanying drawings, which are included to provide further understanding of the subject technology and are incorporated in and constitute a part of this specification, illustrate aspects of the subject technology and together with the description serve to explain the principles of the subject technology.
In the following detailed description, numerous specific details are set forth to provide a full understanding of the subject technology. It will be apparent, however, to one ordinarily skilled in the art that the subject technology may be practiced without some of these specific details. In other instances, well-known structures and techniques have not been shown in detail so as not to obscure the subject technology.
A phrase such as “an aspect” does not imply that such aspect is essential to the subject technology or that such aspect applies to all configurations of the subject technology. A disclosure relating to an aspect may apply to all configurations, or one or more configurations. An aspect may provide one or more examples of the disclosure. A phrase such as “an aspect” may refer to one or more aspects and vice versa. A phrase such as “an embodiment” does not imply that such embodiment is essential to the subject technology or that such embodiment applies to all configurations of the subject technology. A disclosure relating to an embodiment may apply to all embodiments, or one or more embodiments. An embodiment may provide one or more examples of the disclosure. A phrase such “an embodiment” may refer to one or more embodiments and vice versa. A phrase such as “a configuration” does not imply that such configuration is essential to the subject technology or that such configuration applies to all configurations of the subject technology. A disclosure relating to a configuration may apply to all configurations, or one or more configurations. A configuration may provide one or more examples of the disclosure. A phrase such as “a configuration” may refer to one or more configurations and vice versa.
Reference will now be made in detail to embodiments of the present disclosure, examples of which are illustrated in the accompanying drawings. The same reference numbers will be used throughout the drawings to refer to the same or like parts.
System 10 may be used in a variety of applications such as for implantation in one or more vessels, typically vessels between 2.5 mm and 5.0 mm in diameter. System 10 may be used to treat ischemia, such as oxygen depravation due to atherosclerotic stenosis or an embolic event such as the rupture or potential rupture of vulnerable plaque. System 10 may be used to treat a vascular malformation, such as an aneurysm, an arteriovenous malformation, or an arterio-venous fistula. Implant locations include but are not limited to: neurovascular sites, such as to treat a hemorrhagic or other intracranial brain aneurysms; in-situ vessels of the heart, such as to treat an occluded coronary artery; grafts proximate the heart, such as to treat a saphenous vein graft previously placed in a coronary artery bypass procedure; central vascular locations, such as to treat an abdominal aortic aneurysm; and peripheral sites, such as to treat an aneurysm in a popliteal or renal artery.
System 10 includes delivery device 100 configured to position a mechanically expandable device, implant 150, in a vessel such that the exterior surface of implant 150 is expanded to engage the inner surface of the vessel so as to maintain the flow of fluid, e,g. blood, through the vessel. Implant 150 typically includes membrane 160 which may expand in response to the expansion of implant 150. Membrane 160 or another portion of device 100 may include a coating, such as a hydrophilic coating and/or a coating configured to release one or more drugs or other agents, described further below. One or more drugs, reagents or other agents can be coated onto one or more surfaces of device 100. Alternatively or additionally, one or more agents can be mixed, embedded, or covalently bonded with polymeric materials that are coated onto one or more surfaces of device 100. Alternatively or additionally, one or more agents can be loaded into a suitable vehicle (e.g. a polymer solution) that can subsequently be bonded to device 100. Membrane 160 is typically a porous membrane, such as the porous membrane described in reference to
Implant 150, having a generally tubular structure, includes frame 158 where frame 158 includes a plurality of struts 151 and spaces therebetween. Implant 150 can be self-expandable (e.g. resiliently biased in the expanded state), implant 150 can be balloon expandable (e.g. plastically deformable via an inserted balloon), or implant 150 may include at least a first portion that is self-expandable and at least a second portion that is balloon expandable, as is described in detail herebelow. In a typical embodiment, implant 150 can expand to the “healthy” (e.g. non diseased) diameter of a vessel, plus an additional 0.5 mm. In vessels with healthy diameters between 2.75 mm and 4.0 mm, implant 150 can be expanded to approximately 3.25 mm to 4.5 mm, respectively. In some embodiments, implant 150 can expand to a diameter of a healthy vessel plus a value less than 0.5 mm, or less than 0.25 mm. In some embodiments, implant 150 can be expanded such implant 150 inner diameter approximates the inner diameter of the vessel.
The length of implant 150 may be selected to be the length of an aneurysm neck plus 15 mm. For example, a first end of implant 150 can be positioned 5 mm proximal to a proximal end of the aneurysm neck, and a second end of implant 150 can be positioned 10 mm distal to the distal end of the aneurysm neck. Once radially expanded, implant 150 may be configured to maintain a relatively constant diameter under systolic pressures. In some embodiments, changes in vessel diameter may cause limited diameter changes to implant 150. In some instances, an aneurysm may have a small neck, e.g. 1.5 mm to 2.0 mm, and in this case, device 100 can have a length of approximately 12 mm to 17 mm, typically 14 mm. Implant 150 length and material characteristics may be chosen such that a vessel in which implant 150 is to be implanted does not straighten more than would be well tolerated by the vessel.
While implant 150 may have a variety of forms and configurations,
Frame 158 includes an interior surface which is smooth and continuous, thus eliminating or minimizing frictional surface micro-turbulence. Also, frame 158 may include an exterior surface completely encapsulated with a polymer coating, not shown, but configured to minimize vessel wall injury, such as injury caused during delivery and when compressed during cardiac cycles. The polymer coating may further protect from an undesired frame 158 material effects, such as a heavy metal ion response, for example, a Nickel allergic reaction. The polymer coating is preferably a soft, super-elastic, bio-compliant, ultra thin polymer selected from the group consisting of: fluoropolymers, polyimides, silicones, polyurethanes, polyurethanes ethers, polyurethane esters, polyurethane polycarbonate, polyurethane ureas, mixtures and copolymers thereof, and combinations of these. Additionally, the polymer coating may ensure that the exterior surface does not include any acute points or sharp edges such that frame 158 is atraumatic to the vessel wall, e.g. does not cut the endothelium. In some embodiments, a polymer coating is not included on proximal rings 165a and/or distal rings 165b, such as to allow distal and/or proximal ends of implant 150 to expand further (e.g. not be constrained by a polymer coating), ensuring better adaptation to the vessel wall. In addition, the removal (or not including) of the polymer coating from rings 165a and 165b and/or the struts 151 proximate to rings 165a and/or 165b can allow blood to flow through struts 151 without disturbing flow. Further, uncoated struts 151 and/or proximal rings 165a and/or distal rings 165b may help anchor implant 150 to the vessel wall. In some embodiments, the polymer coating may take the form of a membrane, for example, membrane 160. In other embodiments, a polymer coating surrounding all or a portion of frame 158 is included in addition to membrane 160. In some embodiments, rings 165a and/or 165b may be coated with a radiopaque material, for example a gold material.
Membrane 160 may comprise a polymer material. Polymers may be selected from the group consisting of: fluoropolymers, polyimides, silicones, polyurethanes, polyurethanes ethers, polyurethane esters, polyurethane polycarbonate, polyurethane ureas, mixtures and copolymers thereof, and combinations of these. Membrane 160 may be biodegradable, or it may include portions that are biodegradable and portions that remain relatively stable after implantation. In one embodiment, membrane 160 may completely surround the exterior surface (i.e. full length and circumference) of implant 150. In another embodiment, membrane 160 surrounds a portion of the full length of implant 150, around the full or partial circumference of implant 150. In yet another embodiment, membrane 160 covers a portion of the circumference of implant 150, along a partial or full length of implant 150. In yet another embodiment, membrane 160 may be in the form of strips; such as in the configurations shown in
In a typical embodiment, membrane 160 has a thickness such that turbulence into side branches is minimized. For example, membrane 160 thickness may range from 0.0005″ to 0.005″, typically 0.001″. In some embodiments, membrane 160 thickness decreases post-expansion of implant 150. For example, membrane 160 thickness can range from 0.001″ to 0.002″ pre-expansion and range from 0.0005″ to 0.002″ post-expansion. Membrane 160 thickness can vary along the length and/or along the circumference of implant 150. Membrane 160 may be a non-porous, solid polymer. Conversely, membrane 160 may be porous, and the pore size may be relatively fixed or variable. It may be desirable to include pores with a size such that blood is not “throttled” into the aneurysm, but rather flows in a “mist” or “cloud” like flow, as shown in reference to
In some embodiments, frame 158 and membrane 160 comprise a single, self-supporting structure, such as a polymer tube (e.g. without including a metal frame). The tubular structure may comprise a polymer selected from the group consisting of: fluoropolymers, polyimides, silicones, polyurethanes, polyurethanes ethers, polyurethane esters, polyurethane polycarbonate, polyurethane ureas, mixtures and copolymers thereof, and combinations of these.
In some embodiments, membrane 160 comprises a polymer or group of polymers, such as the material BioSpan® 2F, developed by Polymer Technology Group of Berkeley, Calif., USA. BioSpan® 2F Segmented Polyurethane is a polytetramethyleneoxide-based aromatic polyurethaneurea with mixed aliphatic and cycloaliphatic diamine chain extender. BioSpan® 2F includes Surface-Modifying End Groups (SME™), which are surface-active oligomers covalently bonded to the base polymer during synthesis. In some embodiments, membrane 160 may comprise BioSpan® F, also developed by Polymer Technology Group of Berkeley, Calif., USA. BioSpan® F is a segmented polyurethane with fluorocarbon as surface modifying endgroups. Additional examples of a polymer material includes: a biodegradable polylactide; a polyether; a polyethylene glycol (biostable); a poly(DL-lactide-co-caprolactone) (PLC); a poly(DL-lactide-co-glycolide) (PLGA) (typically biodegradable); a polyether of varying composition and molecular weight; a polyester; a polycarbonate diol; a copolymer of these; and combinations of these. In some embodiments, the polymer material has a molecular weight ranging from MW 100-2000. The polymer can comprise at least one chain extender comprising one or more diols or multi-functional group comprising one or more bioactive surface modifying groups. Non-limiting examples of chain extenders include: methylene diisocyanate; toluene diisocyanate; hexamethylenediisocyanate; diisocyanates; alkyl-triols such as glycerol and increasing molecular weight analogs; triamines; orthoformic acid; phosphates such as Inositol trisphosphate; Calcitriol; cyclic polyols (Cyclitols); Ciceritol; short chain functionalized amino acids; polyketides characterized by three hydroxyl groups such as Tautomycin; lipidoid C12-200; fluoroalkane; fluoroalkanols; and combinations of these. In some embodiments, the polymer can comprise at least one end group that can be functionalized prior to incorporation into the polymer. In some embodiments, the polymer can comprise a reactively functionalized polymer including: an allyl-alkyl hydroxide and amine; a siloxy-containing reactive functionalities; a poly methyoxy and polyethyoxy low molecular weight complex; and combinations of these. The polymers described herein can be configured as nanoparticles; self encapsulating particles (e.g. for multiple drug delivery systems); coatings for stents such as stent 150, 150′ and/or 250 described herein, catheters, or other medical devices; and combinations of these. The inclusion of drugs and/or other agents in polymers as described herein is known to those of skill in the art.
The polymers described herein can be made to include radio-lucent or radio-opaque properties by various methods including the addition of a halogen such as bromine or iodine; a ceramic; a metal such as stainless steel, gold, silver or platinum as non-limiting examples; and combinations of these. In some embodiments, gels and/or gel-sols containing these materials, e.g. as nanoparticles, can be embedded in the polymer and/or combined onto the surface in sufficient concentration. Additionally or alternatively, one or more markers can be placed along implant 150 and/or delivery device 100 as described herein.
System 10 includes delivery device 100. Delivery device 100 comprises an interventional catheter construction including shaft 101 and shaft 102. Shaft 101 includes lumen 103, and shaft 102 includes lumen 104. Lumen 104 exits through a side wall of shaft 101 at port 118. Lumen 103 is in fluid communication with an inflatable element, balloon 114. Port 117, typically a luer connector, provides fluid communication to lumen 103, such as to inflate balloon 114 with gas or liquid, typically a 50/50% saline/contrast mixture. Port 118 is positioned in a distal portion of device 100, and is sized and constructed to allow a guidewire, not shown but typically a 0.014″ guidewire, to enter the side of shaft 101, and travel through lumen 104 of shaft 102, exiting the distal tip 105 of device 100 (i.e. a rapid exchange guidewire configuration). In an alternate embodiment, device 100 is an over-the-wire system, such that a guidewire can be introduced through port 117 on the proximal end of device 100 and exit distal tip 105. All or a portion of shaft 101, shaft 102 and balloon 114 may be lubricous and/or include a lubricious coating such as a hydrophilic coating. In one embodiment, the distal portion of device 100 is formed of more flexible materials than that of the mid and proximal portions of device 100. The more flexible distal portion may comprise a length sufficient to navigate through particular vessel tortuousity, such as the tortuousity in vessels proximate the brain, while the stiffer mid and proximal portions of device 100 provide column support sufficient for advancement of device 100 to the desired locations. For example, the length of a more flexible distal portion of device 100 may range from 32 cm to 38 cm, typically 36 cm.
Delivery device 100 may include one or more markers, such as a marker selected from the group consisting of: radiopaque markers such as markers that can be viewed with X-ray or fluoroscopy; visible markers such as markers that can be viewed with a visible intraluminal camera; infrared markers such as markers that can be viewed with an infrared intraluminal camera; ultrasound markers such as markers that can be viewed with external ultrasound or intravascular ultrasound; magnetic markers such as markers that can be viewed with MRI; and combinations of these. In the illustrated embodiment, shaft 102 includes two markers 159a and 159b where marker 159a is positioned on shaft 102 correlating to a proximal portion of balloon 114 and/or implant 150 and marker 159b is positioned on shaft 102 correlating to a distal portion of balloon 114 and/or implant 150.
Shaft 101 may comprise multiple layers, such as two layers comprising a co-extrusion of Pebax™ 55D and HDPE. Shaft 102 may comprise multiple layers as well, such as two equally thick layers of nylon, for example Grilamid nylon. Shafts 101 and/or 102 may comprise a ribbon coil, such as is described in reference to
System 10 can further include a guide catheter, not shown, but typically a 6F (0.070″ ID) guide catheter employed to introduce delivery device 100 into a vessel.
System 10 may include a shaped mandrel, shown and described in reference to
Balloon 114 is configured to expand implant 150 radially outward from a first radially compact position to a second, expanded position, where the expanded position is shown in
Balloon 114 can include at least one fold. In one embodiment, balloon 114 can be a 3-fold balloon. In another embodiment, balloon 114 can be a 5-fold balloon. In yet another embodiment, balloon 114 can be a 6-fold balloon. By increasing the amount of folds in balloon 114, it will decrease the profile and assist in the removal of balloon 114 from implant 150 after deployment, especially in tortuous anatomy. In yet another embodiment, balloon 114 can be a spiral-fold balloon, also decreasing the balloon profile. Specifically, when a spiral is pulled, it reduces in diameter, thus assisting in the removal from implant 150 when in tortuous anatomy. Exemplary balloon 114 configurations are shown in detail in
Balloon 114 may be formed of suitable materials such as: irradiated polyethylene; polyethylene terephthalate; polyvinylchloride; nylon such as Nylon-12 L2140, L25, L2125, and L2101; and copolymer nylons, such as Pebax™; and combinations of these.
Balloon 114 can include at least one marker, not shown, but for example, a distal marker and a proximal marker selected from the group consisting of: radiopaque markers such as markers that can be viewed with X-ray or fluoroscopy; visible markers such as markers that can be viewed with a visible intraluminal camera; infrared markers such as markers that can be viewed with an infrared intraluminal camera; ultrasound markers such as markers that can be viewed with external ultrasound or intravascular ultrasound; magnetic markers such as markers that can be viewed with MRI; and combinations of these. In one embodiment, balloon 114 includes two markers where the distance between the first marker and a distal end of implant 150 and the distance between the second marker and a proximal end of the implant 150 ranges from 0.5 mm to 1.5 mm, and preferably 0.5 mm. System 10 may be provided with a choice of lengths of implant 150. In one embodiment, system 10 is provided with four lengths of implant 150, termed herein as short, moderate, long and extra-long. In the case of the short implant, implant 150 is approximately 15.0 mm long and the space between the inside edges of the first and second marker of delivery system 100, i.e. balloon 114 marker spacing, is approximately 18 mm, with a minimum of approximately 17.5 mm. In the case of the moderate implant, implant 150 is approximately 20.0 mm long and the balloon 114 marker spacing is approximately 23.5 mm, with a minimum of 23.0 mm. In the case of the long implant, implant 150 is approximately 25.0 mm long and the balloon 114 marker spacing is approximately 28.5 mm, with a minimum of approximately 28.0 mm. In the case of the extra-long implant, implant 150 is approximately 30.0 mm long and the balloon 114 marker spacing is approximately 33.5 mm with a minimum of approximately 33.0 mm. One exemplary purpose of the balloon markers is to identify the working length of balloon 114, where the marker spacing is selected based upon the size of implant 150 to prevent the ends of implant 150 from flaring, thus minimizing the risk of implant 150 being delivered prior to the desired placement in a vessel.
In one embodiment, system 10 includes a distal portion with a cross-sectional profile that ranges from 0.045″ to 0.060″, such as to be inserted into a guide catheter, not shown, but typically a 6F guide catheter having an inner diameter of 0.070″.
Various design attributes can be selected such that self-expanding implant 250 demonstrates the desired flexibility and compliance, for example attributes including but not limited to: the number of wires; braiding angle; weave configuration; and combinations of these. By selecting the appropriate design attribute ranges and combinations, implant 250 resists ovalization and kinking in tortuous body lumens, provides the desired radial force when deployed, and provides the proper support to a polymer coating and/or membrane.
In the embodiment illustrated in
Also illustrated in
Weave configuration also contributes to the flexibility and deformation resistance of implant 250. In the embodiment illustrated in
Typically, implant 250 outer diameter 259 ranges from 1.5 mm to 5.0 mm, and implant 250 length ranges from 7.0 mm to 40.0 mm. However, the braided design of frame 258 enables implant 250 to be cut to any desired length, such as when 258 is cut by a clinician, in a sterile setting, during a clinical implant procedure.
The design parameters and materials discussed above may be selected and combined such that the resulting implant displays the desired flexibility and deformation resistance.
The polymer used to create the coverings illustrated in
In the illustrated embodiment, frame 158 is covered by permeable membrane 160 which includes pores 161 and spaces 162. Typically, pore 161 sizes ranges from 20 microns to 200 microns (e.g. a 20 micron to 200 micron diameter or equivalent diameter). Further, pores 161 can be uniformly spaced throughout membrane 160 with a pore spacing 162, i.e. distance between the edges of adjacent pores, typically ranging from 20 microns to 200 microns. Pores 161 may be created by drilling or otherwise forming holes into a solid film. In some embodiments, pores 161 have an initial diameter that expands to a final diameter, for example, pores 161 can be drilled such that pore size is approximately 20 microns and expand to a final diameter of 100 microns. In alternate embodiments, pore size does not expand from the initial size, in other words, pores 161 are manufactured to a final diameter. Pores 161 may be various geometric shapes, for example, circular; elliptical; rectangular; triangular; trapezoidal, and combinations of these.
Subsequent to covering frame 158 with membrane 160, membrane 160 can be trimmed, for example, manually, along trim line 166. In one embodiment, the distance between trim line 166 and frame 158 ranges from 10 microns to 15 microns, typically approximately 12 microns. In some embodiments, proximal rings 165a and distal rings 165b do not include membrane 160, allowing distal and proximal ends of implant 150 to expand further, such as to ensure better adaptation to a vessel wall. Additionally, rings 165a and 165b, without polymer, can provide anchoring or other retention forces between implant 150 and the vessel wall. In the illustrated embodiment, rings 165a and 165b can include teeth 156 configured to secure a marker in place, marker not shown but typically a radiopaque marker.
As shown in
Implant 150 can be balloon expandable, self-expanding, or include both balloon expandable and self-expanding portions, as described herein. Further, implant 150 can be implanted and expanded via delivery device, for example delivery device 100 described herein. A secondary expansion device, such as a second balloon device, may be used to modify the placement of (e.g. to further expand) implant 150.
In some embodiments, balloon 114 can include optimized balloon folds, not shown, but result in better refolding of balloon 114 after the associated implant, such as implant 150 of
Balloon 114 diameter can range from 3.25 mm to 4.5 mm. In some embodiments, balloon 114 includes tapered proximal and distal ends. In some embodiments, the distal and/proximal taper length is approximately 1.5 mm to 5.0 mm. Balloon 114 taper angle can range from 14° to 67°. Balloon 114 may be formed of suitable materials such as: irradiated polyethylene; polyethylene terephthalate; polyvinylchloride; nylon; and copolymer nylons, such as Pebax™; and combinations thereof. In some embodiments, balloon 114 includes Nylon 12, L2140 which has a high tensile strength, high rated burst pressure and maintains a heat set fold under high inflation pressures, such as 12 atmospheres of pressure. Balloon 114 properties can vary along the length of the balloon. Non-limiting examples of balloon 114 properties include: taper angle, taper length, and wall thickness. Balloon 114 may include more than one taper angle, causing the taper length to shorten, such that balloon 114 is more easily withdrawn after implant placement and balloon 114 deflation. Additionally or alternatively, balloon 114 wall thickness can be greater along the tapered length of balloon 114.
In one embodiment, shaft 102 comprises a multi-layer construction, such as two layers comprising a co-extrusion of Pebax™ 55D and PTFE. In another embodiment, the two layers comprise a co-extrusion of Pebax™ 55D and HDPE. Shaft 102 includes ribbon coil 180 configured to provide one or more functions including but not limited to: preventing collapse of shaft 102 (e.g. occluding lumen 104); preventing undesired bending such as to provide better guidewire movement within lumen 104 when shaft 102 is placed in tortuous vessel anatomy; providing improved pushability of (e.g. ability to smoothly advance) device 100; reducing the risk of kinking such as when implant 150 is deployed in an acute curve or other vessel tortuousity commonly experienced in neurovasculature; and providing improved uniformity of deployment of implant 150. Coil 180 may include one or more markers, e.g. radiopaque or other visualizable markers, thus increasing visibility of shaft 102. In this embodiment, shaft 102 durometer may be softer than shaft 102 without the reinforcement provided by coil 180. For example, with coil 180, shaft 102 durometer may range from 35D to 72D, preferably 55D. The width of coil 180 may range from 0.001″ to 0.004″; coil 180 thickness may range from 0.0005″ to 0.002″; and coil pitch may range from 0.004 to 0.012″. Coil 180 material may be stainless steel 304V and may include dimensions of 0.00225″ wide by 0.0008″ thick, with a 0.0058″ pitch. Coil 180 may be wrapped within lumen 104 of shaft 102, or be placed between two layers of shaft 102, such as between a PTFE layer and a Pebax™ 55D nylon outer jacket. In another embodiment, shaft 102 can include a HDPE layer and a Pebax™ 55D nylon outer jacket. In yet another embodiment, shaft 102 includes three layers in addition to coil 180. For example, the three layers of shaft 102 may include a PTFE layer, a Pebax™ layer, and a bonding layer of urethane positioned therebetween.
Space 107 is typically in fluid communication with a lumen of a proximal shaft, such as lumen 104 of shaft 102 of
Distal navigation segment 200 is positioned as shown, on a distal portion of device 100. Distal navigation segment 200 is constructed and arranged such that at least a portion of tip 201 can advance around a tight turn, then providing a smooth transition of the remaining more proximal components of delivery device 100. Distal navigation segment 200 can be created by extending shaft 102 a length of approximately 6.0 mm+/−0.5 mm beyond a bonded portion of the distal end of balloon 114, distal bond 203. The segment of shaft 102 extending beyond distal bond 203 is segment 202, which may include a reinforcing layer, e.g. a third layer when shaft 102 proximal portion comprises two layers. In the illustrated embodiment, the third layer includes a 5 mm length segment of Pebax™ 2533 and a 5 mm segment of Pebax™ 3533, bulking shaft 102 from an initial outer diameter to larger final outer diameter, for example, from an initial diameter of 0.022″ to a final diameter of 0.027″. Therefore, in the multilayer construction of shaft 102 described above, distal navigation segment 200 may include an inner layer of HDPE, a middle layer of Pebax™ 55D, and an outer layer of Pebax™ 2533/3533, such as to result in a 0.027″ outer diameter and a total length of 12 mm. Additionally or alternatively, the inner layer may include PTFE. In an alternate embodiment, distal navigation segment 200 may be 6 mm in length and include a single polymer with a durometer ranging from 25D to 55D, preferably 35D. As described above, distal navigation segment 200 further includes a distal tip, typically, a relatively flexible, floppy tip 201. In one embodiment, floppy tip 201 includes Pebax™ 63D, is approximately 3 mm in length, and provides a less traumatic cushion tip while maintaining sufficient durability. The final dimensions also account for a 0.25 mm to 1.5 mm overlap for shaft 102 to mate with the outer layer of Pebax™ 2533. In this configuration, the total distance beyond distal bond 203 is approximately 9 mm, which includes 6 mm for extension 202 and 3 mm for tip 201, including overlaps. Delivery device 100 may include one or more markers 191, typically radiopaque markers configured to enhance visibility or other visualizable markers as are described herein. Similarly, balloon 114 may include one or more markers 190, typically radiopaque markers configured to enhance visibility or other visualizable markers.
In another embodiment, distal navigation segment 200 may include a softer material, such as Pebax™ 40D, enabling the diameter of the segment 200 to be larger, typically similar to the distal end of shaft 106, while providing sufficient flexibility. Distal navigation segment 200, such as when comprising Pebax™ 40D, may be fused with tip 201 and shaft 102, with segment 200 remaining sufficiently flexible.
STEP 1110 further includes preparing an access site, where the access site may be selected from the group consisting of: femoral artery; brachial artery and radial artery. Also in this step, a distal portion of a guidewire, typically a 0.014″ guidewire, is positioned in the target vessel. While maintaining the position of the guidewire in the vessel, the delivery device is loaded onto a proximal end of the guidewire. The implant may be pre-mounted on the delivery device, or the implant may be applied to the delivery device in the clinical setting. Angiography and/or fluoroscopy can be performed to confirm proper placement of the guidewire. The delivery device is advanced over the guidewire to the target vessel. Angiography and/or fluoroscopy may be performed to confirm positioning of the distal portion of the delivery device and/or the pre-deployed location of the implant. In some embodiments, the implant is advanced to a location distal to the target deployment location for the implant, followed by gently retracting the delivery device to position the implant at the target location. This technique can be employed to ensure any potential slack is relieved, thus reducing the possibility of movement during inflation of a deploying balloon and/or retraction of a sheath (e.g. a sheath surrounding a self-expanding implant). In a next step, an inflatable element, e.g. a balloon integral to the delivery device, may be inflated. Prior to inflation, the balloon and its inflation lumen may be purged of air, such as with a small 4-cc snub-nose flushing syringe.
STEP 1120 may include inflating balloon such that the implant reaches the desired diameter, i.e. diameter of the vessel, typically, 2.0 mm to 5.0 mm, such as when the implant is a plastically deformable device. In some embodiments, the implant can be expanded such that the implant inner diameter matches that of the vessel inner diameter (e.g. expanded with a balloon with a diameter slightly greater than the vessel inner diameter). The opening pressure, i.e. pressure at which the implant is fully open, may be approximately 5 atm. In an alternative embodiment, the implant comprises a self-expanding implant, and the implant is deployed by pulling back a retractable sheath, as is described in reference to
Contact between the implant and the vessel wall is desired and can be confirmed via MRI, Dyna CT, Angio CT, angiography and/or fluoroscopy. After the implant is expanded to the desired diameter, the balloon can be deflated completely. A vacuum can be applied with the inflation device and held until most of the contrast solution is removed from the system and the balloon folds are folded. In a next step, the delivery device may be removed over the guidewire.
In STEP 1130, the implant can optionally be further plastically deformed and/or otherwise radially expanded post-deployment, such as by using a post-dilatation balloon configured to increase the diameter of a specific portion of the implant. One or more expansion steps may be performed until the correct mating with the vessel walls is achieved, e.g. to eliminate false lumens, such that no leak is observed. In some embodiments, the post dilatation balloon can be positioned and operated to expand a proximal portion of the implant prior to expanding a distal portion of the implant. In one embodiment, STEP 1130 is performed immediately after STEPs 1110 and 1120 are performed, i.e. during the same procedure. Additionally or alternatively, STEP 1130 can be performed during a second procedure, for example a procedure performed one day, one week, one month, or six months later, and any combinations of these. Finally, the guidewire is removed after all access to the deployed implant is complete.
Other components of delivery device 100′ are typically similar to and described in detail in reference to the same numbered components of delivery device 100 of
In the illustrated embodiment, frame 158 includes four portions, portions 167a-d, where portions 167a-d comprise properties that can be similar from portion to portion, or can vary from portion to portion. In one non-limiting embodiment, portions 167a and 167b can be plastically deformed during the radial expansion of implant 150 while portions 167b and 167c can be resiliently biased when implant 150 is in an expanded state. Other properties than can be varied from portion 167a through portion 167d include but are not limited to: flexibility; rigidity; biodegradability; and combinations of these. These properties can be achieved via the materials used and/or coatings. For example, portions 167a and 167d can comprise a more rigid material to achieve more rigid ends of implant 150, and portions 167b and 167c can include a more flexible material. Additionally or alternatively, portions 167a and 167d can include a coating, for example a lubricious coating, while portions 167b and 167c do not include a coating. These properties or any other physical, chemical, or mechanical property can be combined in any way so as to achieve the desired implant 150.
In the illustrated embodiment, frame 158 is covered by permeable membrane 160 which includes pores 161 and spaces 162. Similar to frame 158, membrane 160 can include portions, for example portions 168a-c. In one embodiment, membrane 160 has a uniform porosity, for example, portions 168a-c include pores 161 comprising approximately the same diameter as well as approximately the same distance between adjacent pores 161. In an alternative embodiment, membrane 160 has a non-uniform porosity, for example pore size and/or distance between adjacent pores 161 varies from portion 168a to portion 168b to portion 168c. Alternatively or additionally, pore geometry can vary across membrane portions 168a-c. For example, portion 168a can include round pores, portion 168b can include elliptical pores, and portion 168c can include pores in a rectangular, slit shape. In another non-limiting example, portion 168a and portion 168c includes round holes, while portion 168b includes elliptical pores. In this embodiment, a first porosity can be achieved at the ends of implant 150 and a second, different porosity can be achieved at the mid portion of implant 150. In some embodiments, membrane 160 is configured to deliver a drug(s), reagent(s) and/or other agent(s) to a vessel simultaneous with or after implantation of implant 150. Portions 168a-c can include the same or different drugs or agents configured to be released simultaneously or sequentially. For example, membrane portion 168a can include a first drug configured to be released immediately after implantation of implant 150, and portion 168b includes a second drug configured to be released one day after implantation, and portion 168c includes a third drug configured to be released one month after implantation. In an alternative embodiment, the entire membrane can include a drug(s) and/or agent(s). Alternatively or additionally, membrane 160 can include a coating, for example a lubricous coating included in portion 168a, b, and/or c, or the coating can cover the entire implant 150.
The cold process comprises wrapping and crimping implant 150 onto balloon 114, followed by inflating balloon 114 with pressurized nitrogen into a die. Typically, balloon 114 is inflated so that its inner diameter is approximately 0.070″-0.073″. Subsequently, implant 150 is crimped onto balloon 114.
The heat induced process comprises crimping implant 150 onto balloon 114, followed by placing a tubular conduit around implant 150 to prevent implant 150 from expanding during the expansion of shoulders 115a and 115b, the tubular conduit not shown but can comprise at least one of Polyimide, reinforced PTFE, or polished stainless steel. Optionally, an additional tubular conduit, also not shown but can be placed over at least one of the distal end or proximal end of balloon 114 to define the final outer diameter of balloon shoulders 115b and 115a, respectively. Subsequently, balloon 114 including implant 150 is placed in an oven and pressurized with Nitrogen where balloon 114 is molded into the “dogbone” shape. In one embodiment, oven temperature ranges from 50° to 70° C., typically from 55° to 65°; bake time ranges from 30 seconds to 15 minutes, typically from 5 minutes to 10 minutes; and Nitrogen pressure ranges from 5 psi to 60 psi, typically from 10 psi to 50 psi. After the pressurization and heat set process, the tubular conduit is removed from implant 150, as well as any optional tubular conduits placed around balloon distal and proximal ends.
Upon reaching the desired implantation location, balloon 114 can be further expanded such that the outer diameter of balloon 114 approximately matches the inner diameter of implant 150, and implant 150 can be implanted at the vessel location, as shown in
In the embodiments shown in
A post-dilatation balloon as has been described herein, can comprise an extended inflation shaft and lumen, constructed and arranged similar to shaft 101 of delivery device 100 of
System 10 includes implant 150′, delivery wire 501 and micro-catheter 500. System 10 can be configured for treatment of an aneurysm located in a blood vessel. such as a blood vessel in the brain of a patient. Implant 150′ can comprise a self-expanding implant, or comprise one or more self-expanding portions as have been described herein. Implant 150′ can be delivered to a vessel via micro-catheter 500 and delivery wire 501. Delivery wire 501 can be operably attached to implant 150′ and configured to advance and/or retract implant 150′ to and from micro-catheter 500. Implant 150′ can be loaded into micro-catheter 500 by manually compacting implant 150′ and inserting it into micro-catheter 500, and advancing delivery wire 501 and implant 150′ to the position shown in
In some embodiments, delivery wire 501 and micro-catheter 500 are constructed and arranged similar to the transport wire and micro-catheter included in the Asperio Thrombectomy System provided by Acandis Aperio GMBH & Co. KG of Pforzheim, Germany. Alternatively or additionally, delivery wire 501 and micro-catheter 500 are constructed arranged as described in U.S. patent application Ser. No. 13/320,148, entitled “Medical Device for Releasing in a Hollow Organ and Insertion System for Medical Devices” and filed Dec. 1, 2011, incorporated herein by reference in its entirety.
In some embodiments, implant 150′ may be implanted, and implant 150″ may be implanted in approximately the same position (e.g. the mid-portion of each is aligned at the same location in the vessel). In the illustrated embodiment, implant 150″ is longer than implant 150′ and implanted such that implant 150 extends past both the proximal and distal ends of implant 150′. In some embodiments, implant 150′ and implant 150″ may be implanted such that they overlap one another, having any amount of overlap, for example where the overlapping portion is proximate an aneurysm. In some embodiments, implant 150′ and implant 150″ may be implanted in a tandem configuration.
As stated above, implant 150′ and implant 150″ may be similar or dissimilar in construction, e.g. similar or dissimilar materials, braid configuration, size, coatings, radiopacity, inclusion of radiopaque markers, and the like. Implant 150 and implant 150′ can embody any of the configurations described herein.
The present application incorporates by reference the entirety of U.S. Non-Provisional application Ser. No. 10/580,139, filed Dec. 13, 2004 and published on May 3, 2007 as U.S. Pub. No. 2007/0100430; U.S. Non-Provisional application Ser. No. 11/586,899, filed Oct. 25, 2006 and published on May 3, 2007 as U.S. Pub. No. 2007/0100426; U.S. Non-Provisional application Ser. No. 11/786,023, filed Apr. 9, 2007 and published on Nov. 1, 2007 as U.S. Pub. No. 2007/0255388; and U.S. Non-Provisional application Ser. No. 12/279,335, filed Feb. 13, 2006 and published on Feb. 26, 2009 as U.S. Pub. No. 2009/0054966.
The foregoing description is provided to enable a person skilled in the art to practice the various configurations described herein. While the subject technology has been particularly described with reference to the various figures and configurations, it should be understood that these are for illustration purposes only and should not be taken as limiting the scope of the subject technology.
There may be many other ways to implement the subject technology. Various functions and elements described herein may be partitioned differently from those shown without departing from the scope of the subject technology. Various modifications to these configurations will be readily apparent to those skilled in the art, and generic principles defined herein may be applied to other configurations. Thus, many changes and modifications may be made to the subject technology, by one having ordinary skill in the art, without departing from the scope of the subject technology.
It is understood that the specific order or hierarchy of steps in the processes disclosed is an illustration of exemplary approaches. Based upon design preferences, it is understood that the specific order or hierarchy of steps in the processes may be rearranged. Some of the steps may be performed simultaneously. The accompanying method claims present elements of the various steps in a sample order, and are not meant to be limited to the specific order or hierarchy presented.
As used herein, the phrase “at least one of” preceding a series of items, with the terms “and” or “or” to separate any of the items, modifies the list as a whole, rather than each member of the list (i.e., each item). The phrase “at least one of” does not require selection of at least one item; rather, the phrase allows a meaning that includes at least one of any one of the items, and/or at least one of any combination of the items, and/or at least one of each of the items. By way of example, the phrases “at least one of A, B, and C” or “at least one of A, B, or C” each refer to only A, only B, or only C; any combination of A, B, and C; and/or at least one of each of A, B, and C.
Terms such as “top,” “bottom,” “front,” “rear” and the like as used in this disclosure should be understood as referring to an arbitrary frame of reference, rather than to the ordinary gravitational frame of reference. Thus, a top surface, a bottom surface, a front surface, and a rear surface may extend upwardly, downwardly, diagonally, or horizontally in a gravitational frame of reference.
Furthermore, to the extent that the term “include,” “have,” or the like is used in the description or the claims, such term is intended to be inclusive in a manner similar to the term “comprise” as “comprise” is interpreted when employed as a transitional word in a claim.
The word “exemplary” is used herein to mean “serving as an example, instance, or illustration.” Any embodiment described herein as “exemplary” is not necessarily to be construed as preferred or advantageous over other embodiments.
A reference to an element in the singular is not intended to mean “one and only one” unless specifically stated, but rather “one or more.” Pronouns in the masculine (e.g., his) include the feminine and neuter gender (e.g., her and its) and vice versa. The term “some” refers to one or more. Underlined and/or italicized headings and subheadings are used for convenience only, do not limit the subject technology, and are not referred to in connection with the interpretation of the description of the subject technology. All structural and functional equivalents to the elements of the various configurations described throughout this disclosure that are known or later come to be known to those of ordinary skill in the art are expressly incorporated herein by reference and intended to be encompassed by the subject technology. Moreover, nothing disclosed herein is intended to be dedicated to the public regardless of whether such disclosure is explicitly recited in the above description.
While certain aspects and embodiments of the invention have been described, these have been presented by way of example only, and are not intended to limit the scope of the invention. Indeed, the novel methods and systems described herein may be embodied in a variety of other forms without departing from the spirit thereof. The accompanying claims and their equivalents are intended to cover such forms or modifications as would fall within the scope and spirit of the invention.
This application is the U.S. National Phase under 35 U.S.C. § 371 of International Application No. PCT/US2013/035517, filed Apr. 5, 2013, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/621,434, filed on Apr. 6, 2012. The entirety of which is incorporated by reference, as if fully set forth herein.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/US2013/035517 | 4/5/2013 | WO | 00 |
| Publishing Document | Publishing Date | Country | Kind |
|---|---|---|---|
| WO2013/152327 | 10/10/2013 | WO | A |
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