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Method of delivering a medical device across a plurality of valves

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Title: Method of delivering a medical device across a plurality of valves.
Abstract: Devices and methods for treating veins and venous conditions, such as chronic cerebrospinal venous insufficiency, are provided. In one aspect, the disclosed subject matter provides an intraluminal scaffold having a generally tubular body with a lumen defined therethrough, the tubular body having a compressed condition for delivery and an expanded condition for implant within a vessel having a distended portion, at least a length of the tubular body configured to form an enlarged portion in the expanded condition to engage a wall of the distended portion of the vessel. Methods for fabricating and using the scaffold, methods for remodeling a vein, and methods of deploying a medical device in a vessel without negatively impacting the function of a valve of the vessel, are also provided. ...


Inventors: Randolf von Oepen, Kevin J. Ehrenreich, Kelly J. McCrystle
USPTO Applicaton #: #20120046739 - Class: 623 211 (USPTO) - 02/23/12 - Class 623 
Prosthesis (i.e., Artificial Body Members), Parts Thereof, Or Aids And Accessories Therefor > Heart Valve >Combined With Surgical Tool



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The Patent Description & Claims data below is from USPTO Patent Application 20120046739, Method of delivering a medical device across a plurality of valves.

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CROSS REFERENCES TO RELATED APPLICATIONS

The present application claims priority from U.S. Provisional Application Ser. No. 61/324,031, filed Apr. 14, 2010, which is incorporated by reference in its entirety.

BACKGROUND

1. Technical Field

This disclosed subject matter generally relates to devices and methods for treating veins and conditions related to veins. More particularly, the disclosed subject matter relates to devices and methods that are useful for treating venous anatomies to improve venous sufficiency.

2. Description of Background

Multiple Sclerosis (MS) is a debilitating disease in which the myelin surrounding the nerves is damaged, resulting in inhibition of nerve communication and impairment of physical and cognitive abilities. There is currently no cure for MS, but management of the disease has been advanced through the use of medical treatments, diet, and other non-surgical means. These treatments reflect the lack of a known cause of MS. MS sufferers apparently have a high prevalence of narrowing, twisting, or blockage of the veins that remove blood from the main extracranial cerebrospinal veins, the jugular, and the azygous venous systems. These abnormalities cause blood “refluxing”, or retrograde flow, which creates reflux in the central nervous system. As a result, pooling of non-oxygenated blood can occur along with pericapillary iron deposition. Since iron is known to create free radicals that are toxic to cells, it is hypothesized that the MS inflammations may be caused by these iron deposits as seen in CVD, mentioned above. The high iron content of MS patients' brains has been confirmed. The work led to the coining of the venous disorder Chronic Cerebrospinal Venous Insufficiency (CCSVI).

Veins are thin structures that lack some of the muscular features of arteries. Thus, distension of the veins is common. In the internal jugular vein, MS sufferers can develop distension and bulging as shown in FIG. 1. These bulbs can expand, or the entire length of vessel, or a substantial portion thereof, may expand, which causes blood accumulation and reflux as described above. Further, the venous system, and particularly the jugular portion of the venous system, includes valves that operate to allow blood to flow easily in one direction but resist the backflow of blood in the opposite direction. Veins can distend near the venous valves, and this distention can occur on either side of tile valve. For example, the vein may have a barbell shape with the valve in the handle area. Thus, the valve can act as a stenosis that restricts blood now in both directions and thereby inhibits now. Poor venous drainage and the resulting deposition of iron may be a primary or secondary cause of other diseases as well. For example, beyond MS, the treatment of CCSVI can also help prevent or treat dementia, Alzheimer's disease, or other diseases of the central nervous system.

There is a need for a method that can be used to reduce the bulbs or distensions within a vein in order to reduce reflux and blood accumulation and thereby treat an underlying disease. There is also a need to maintain a venous valve open since blood now through the jugular veins can be beneficial, particularly in preventing pooling of blood in the brain.

Stenting is one option for treating CCSVI because a stent placed in the anatomy would eliminate the narrowing, twisting, or blockage of the veins, and thus prevent refluxing by allowing normal drainage of blood from the brain. Traditionally, cylindrical stents have been used in the treatment of vascular disease. That is, stents in their as-cut configuration are traditionally cylindrical. The reason for this is essentially twofold. First, the cost of manufacturing a non-cylindrical stent is substantially higher using traditional processes, and second, there has not been a strong demand for non-cylindrical stents since most diseased vessels are essentially cylindrical, and any anatomical deviations can be compensated for through balloon deployment and touch-up. However, there are no stents available on the market that are sized or designed for treating the vessel conditions relevant to CCSVI and the use of cylindrical stents to do so may not be fruitful.

Stenting abnormal vessel segments with traditional cylindrical stents has at least two downfalls. First, such stents have a tendency to dislodge from the vein because the veins have low radial force and are relatively large compared to typical stent diameters. When this happens, the stent may flow downstream and cause risk to the patient if it enters the heart, another organ, or otherwise disrupts blood flow, for example. Second, a stent with a cylindrical profile may not conform fully to a bulbous vein, and there may therefore be poor scaffolding and opportunity for thrombus formation in the gaps between the vein wall and the stent. Thus, there is a need for a stent that can be deployed within non-cylindrical vessel segments that provides the advantages of good vessel conformity in unusual anatomies, and that can produce an anchoring effect within a vein to prevent stent loss.

For many of the devices that may be used for the treatment of CCSVI, access to and delivery within the jugular vein may be necessary. However, as shown in FIG. 2, even basic access to a jugular can be difficult to accomplish without damaging the venous valves. As shown, the venous valves are formed by valve leaflets which are very thin structures that tend to protrude and taper in the antegrade direction. However, since access to the patient anatomy during interventional procedures is commonly made in the radial or femoral region, a guidewire will normally be passed in the retrograde direction. Therefore, as the guidewire is passed into the vein, it may tend to catch the valve leaflets and press against them in a resistive manner. Due to the relative weakness of the leaflets, they may tear or be otherwise damages. If the leaflets tear, they may be unable to resist backflow and therefore their function will be destroyed. This same problem can occur when other devices, such as balloon catheters or other catheter devices, are passed in the same direction as the guidewire. Thus, there is a need for a method and system of accessing the jugular veins that will eliminate or minimize the risk of damaging the valve leaflets.

SUMMARY

The purpose and advantages of the disclosed subject matter will be described and apparent from the description that follows, and through the practice of the disclosed subject matter. This devices and methods disclosed herein can apply to treatment of various venous conditions, including CCSVI.

In accordance with one aspect of the present application, an intraluminal scaffold is provided. The intraluminal scaffold has a generally tubular body with a lumen defined therethrough, the tubular body having a compressed condition for delivery and an expanded condition for implant within a vessel having a distended portion. At least a length of the tubular body is configured to form an enlarged portion in the expanded condition to engage a wall of the distended portion of the vessel. As an example, the enlarged portion can have a non-cylindrical shape.

In some embodiments of the intraluminal scaffold, the enlarged portion has a barrel shape. In some embodiments, the enlarged portion of the tubular body includes a pattern of cells substantially uniform in size when the scaffold is in the expanded condition. The non-cylindrical shaped portion can be formed of a continuous curved strut. In other embodiments, the enlarged portion can have a shape selected from a buttercup shape, a bulbous shape, an hourglass shape, a dumbbell shape, a tapered shape, a flared shape, and a corrugated shape. In one particular embodiment, the enlarged portion includes a spiral-shaped wire. In certain embodiments, the enlarged portion of the tubular body in the expanded condition conforms to the wall of the distended portion of the vessel.

The intraluminal scaffold can be a conforming scaffold, a supporting scaffold, or include one or more portions that either conform or support a vessel in which it is implanted. The scaffold can be balloon expandable, self-expandable or a portion of the scaffold is balloon expandable and the other portion of the scaffold is self-expandable.

In some embodiments, the tubular body of the intraluminal scaffold further comprises a cylindrical portion in the expanded condition extending from at least one end of the enlarged portion of the tubular body. The enlarged portion in the expanded condition can have a profile larger than a diameter of the cylindrical portion in the expanded condition. The enlarged portion can be disposed at an end of the scaffold. The intraluminal scaffold can further include a second cylindrical portion extending from a second end of the enlarged portion.

In some embodiments, the enlarged portion of the intraluminal scaffold includes a bistable construction. The enlarged portion, including the bistable construction, in the expanded condition can have a profile larger than a diameter of the cylindrical portion in the expanded condition. The enlarged portion also can have sufficient flexibility to conform to the distended portion of the vessel without plastic deformation.

In some embodiments, at least a portion of the tubular member of the intraluminal scaffold is formed of a material selected from a polymeric material, a metallic material, and a shape-memory material. In certain embodiments, the cylindrical portion of the intraluminal scaffold is formed of a material different than the enlarged portion. For example, the cylindrical portion can be formed from a material that plastically deforms when expanded to the expanded condition. In certain embodiments, the scaffold is made of a degradable material, for example, a material that is capable of extravascular degradation.

In certain embodiments, the tubular body of the intraluminal scaffold includes a side opening defined therein. The tubular body can further include a side branch in communication with the side opening to accommodate a vessel bifurcation.

In one embodiment, the intraluminal scaffold includes a restraining band to induce formation of the non-cylindrical shape when expanded to the expanded condition. The restraining band can have recoil, and can be formed of a degradable material.

In some embodiments, the tubular body of the intraluminal scaffold conforms to the wall of the vessel during vessel relaxation due to adjustments in fluid flow.

In some embodiments, the tubular body of the intraluminal scaffold recoils from its initial expanded condition over a period of time greater than one day. For example, the recoil can from its initial expanded condition can result from degradation of the material of the scaffold, e.g., a degradable material.

The intraluminal scaffold can further include a therapeutic substance. The therapeutic substance can include any one or more of the therapeutic substances described in the Detailed Description below, and in particular, one or more of fondaparinux (Arixtra®), Enoxaparin, Bivaliruden, a factor Xa inhibitor, a collagenase (e.g., Xiaflex®), or endopeptidase.

The intraluminal scaffold can further include an integrated filter system.

In accordance with another aspect of the disclosed subject matter, a method of treating a condition of a vessel is provided. According to the method, an intraluminal scaffold is provided, which includes a generally tubular body with a lumen defined therethrough, the tubular body having a compressed condition for delivery and an expanded condition for implant within a vessel having a distended portion, at least a length of the tubular body configured to form an enlarged portion in the expanded condition. The intraluminal scaffold is deployed within a distended portion of a vessel with the enlarged portion of the scaffold engaging a wall of the distended portion of the vessel.

As disclosed, the scaffold is deployed in a vein, such as an internal jugular vein. The scaffold can have a length greater than the diameter of the brachiocephalic vein. The vein can have or is subject to a valve anomaly. The tubular body of the scaffold can conform to the wall of the vessel during vessel relaxation due to adjustments in fluid flow.

In some embodiments of the method, the deployed scaffold is allowed to migrate in or adhere to the wall of the vessel. Further, the tubular body of the scaffold recoils from its initial expanded condition after the scaffold migrate in or adheres to the wall of the vessel. The tubular member can be formed of a degradable material. In these embodiments, the tubular member can recoil from its initial expanded condition due to degradation of the degradable material.

In accordance with yet another aspect of the disclosed subject matter, a method of treating a condition of a vessel is provided. The method includes: providing an intraluminal scaffold comprising a generally tubular body with a lumen defined therethrough, the tubular body having a compressed condition for delivery and an expanded condition for implant within a vessel subject to a valve anomaly; deploying the scaffold within the vessel; and allowing the tubular body of the scaffold to conform to a wall of the vessel.

In some embodiments, the above method further includes allowing the scaffold to migrate in or adhere to the wall of the vessel, and can further include allowing the tubular body of the scaffold to recoil from its initial expanded condition after the scaffold migrates in or adheres to the wall of the vessel. The recoil can be resulting from degradation of the material of the scaffold if the material is degradable. Where the scaffold is made of a degradable material, the method can further include allowing the tubular body to migrate through the wall of vessel for extravascular degradation thereof.

In some embodiments of the above method, the scaffold is deployed in a vein, such as an internal jugular vein. The tubular body of the scaffold can conform to the wall of the vessel during vessel relaxation due to adjustments in fluid flow. Additionally or alternatively, the vessel can have a distended portion, and at least a length of the tubular body is configured to form an enlarged portion in the expanded condition. In these embodiments, deploying the scaffold can include engaging the enlarged portion of the scaffold with the wall of the distended portion of the vessel.

In accordance with a further aspect of the disclosed subject matter, a method of treating a condition of a vessel is provided selecting a patient demonstrating a symptom associated with a condition selected from fatigue, chronic fatigue, venous insufficiency of the leg, chronic venous insufficiency, deep vein thrombosis, Alzheimers, adult onset dementia, Parkinsons, May-Thumer, Budd-Chiari, CCSVI, and MS, and deploying an intraluminal scaffold in a vein having or subject to a valve anomaly believed to be associated with the symptom. For example, the scaffold can be deployed in a vein having one or more valves, such as veins having valves which are atypical or irregular in function or otherwise insufficient. Such valves can be associated with a neck (e.g., jugular), a leg, or a liver. As a particular example, the vein can be an internal jugular vein.

In accordance with yet another aspect of the disclosed subject matter, an intraluminal scaffold is provided. The scaffold includes a first annular element radially expandable with respect to a longitudinal axis defined therethrough, a second annular element radially expandable with respect to the longitudinal axis, and at least one axial strut connecting the first annular element and the second annular element. The at least one axial strut has sufficient flexibility to conform to a wall of a distended portion of a vessel.

In some embodiments of the above scaffold, the at least one axial strut has sufficient flexibility to conform to the distended portion of the vessel without plastic deformation. In other embodiments, at least one of the first annular element and the second annular element is plastically deformed when radially expanded. In other embodiments, the at least one axial strut is self-expandable, and at least one of the first annular element and the second annular element is balloon-expandable. In other embodiments, the at least one axial strut and at least one of the first and second annular elements are each self-expandable. In certain embodiments, the at least one axial strut is made of a material in its austenitic phase and at least one of the first annular element and second annular element is made of a material in its martensitic phase. The at least one axial strut can be made of a polymer material. In other embodiments, the at least one axial strut is made of a linear elastic material.

In some embodiments, the first annular element has a different diameter than the second annular element when in the expanded condition. In some embodiments, the first annular element or the second annular element can include a meandering pattern, such as a sinusoidal ring.

In some embodiments, the at least one axial strut defines a radially outward strength lower than that of the first annular element or the second annular element.

In some embodiments, the at least one axial strut includes a plurality of axial struts. In these embodiments, the scaffold can further include at least one radial connector disposed between and connecting a selected pair of circumferentially adjacent axial struts. The plurality of axial struts can form a bulbous shape when expanded.

In accordance with another aspect of the disclosed subject matter, a method of fabricating an intraluminal scaffold is provided. The method includes providing a tubular body with a lumen defined therethrough, at least a length of the tubular body configured to form an enlarged portion, and defining a plurality of cells in the tubular body to form an intraluminal scaffold capable of having a compressed condition for delivery and an expanded condition for implant within a vessel, the at least a length of the tubular body having the enlarged portion when in the expanded condition.

In one embodiment of the fabrication method, providing the tubular body includes extruding a generally cylindrical tube and expanding at least a portion of the cylindrical tube to form the enlarged portion. In one embodiment, expanding at least the portion of the cylindrical tube includes blow molding to form the enlarged portion. In another embodiment, expanding at least the portion of the cylindrical tube includes hydroforming the enlarged portion.

In some embodiments, the tubular body is made of a polymeric material. Alternatively, the tubular body material can include a metal or a metal alloy.

In some embodiments, providing the tubular body includes depositing tubular body material on a mandrel having a surface defining the enlarged portion. In other embodiments, defining the plurality of cells in the tubular body includes depositing the tubular body material on select locations of the surface of the mandrel. In yet other embodiments, defining the plurality of cells in the tubular body includes removing material from the tubular body, e.g., laser cutting the tubular body.

In some embodiments, the plurality of cells are uniform in size and shape. In other embodiments, the plurality of cells are nonuniform in size or shape.

In accordance with another aspect of the disclosed subject matter, a method of deploying a medical device is provided. The method includes: establishing an open condition of a valve in a vessel of a patient; moving a medical device through the opened valve; and deploying the medical device at a target site, wherein establishing the open condition, moving the medical device and deploying the medical device are completed without negatively impacting the function of the valve.

In the above method of deploying the medical device, establishing the open condition of the valve can include altering fluid flow through the vessel in the vicinity of the valve. For example, a fluid can be introduced in an antegrade direction from a location upstream of the valve to induce opening of the valve. Before introducing the fluid, the vessel can be occluded at a location upstream of the valve. Alternatively, the fluid flow can be drawn in an antegrade direction, for example, by providing suction at a location downstream of the valve, to open the valve. In either case, the medical device can be moved from a retrograde direction through the opened valve from a location downstream of the valve. In other embodiments, altering fluid flow in the vicinity of the valve includes occluding at least one body lumen proximal to and fluidly coupled with the vessel to increase antegrade flow across the valve.

Alternatively, establishing the open condition of the valve includes temporarily expanding an expandable cuff within the valve without permanently impacting the function of the valve.

In some embodiments, deploying the medical device includes using a catheter, and the method further include removing the catheter after deploying the medical device. The medical device can be an intraluminal scaffold. Further, the intraluminal scaffold can have a generally tubular body with a lumen defined therethrough, the tubular body having a compressed condition for delivery and an expanded condition for implant within the vessel, at least a length of the tubular body configured to form an enlarged portion in the expanded condition.

In some embodiments, the valve is a venous valve. The venous valve can be located in one of an internal jugular vein and an external jugular vein.

In accordance with another aspect of the disclosed subject matter, a method of deploying a medical device across a plurality of valves of a vessel of a patient is provided. A catheter is provided which has an inner shaft member and an outer shaft member co-axially disposed and axially moveable relative to each other. The catheter is positioned in a vessel having a plurality of valves including a first valve and a second valve. A distal end of the outer shaft member is advanced across the first valve without permanently impacting the function of the first valve; moving the inner shaft member axially relative to the outer shaft member; and advancing a distal end of the inner shaft member across the second valve without permanently impacting the function of the second valve.

In some embodiments of the above method, the distal end of at least one of the inner shaft member and the outer shaft member is formed with an atraumatic configuration.

In some embodiments, the method further includes delivering a medical device through the inner shaft member to a target site. The medical device can be an intraluminal scaffold. The scaffold can have a generally tubular body with a lumen defined therethrough, the tubular body having a compressed condition for delivery and an expanded condition for implant within the vessel, at least a length of the tubular body configured to form an enlarged portion in the expanded condition. In some embodiments of the method, the plurality of valves are venous valves.

BRIEF DESCRIPTION OF THE DRAWINGS

For a further appreciation of the above and other advantages, reference is made to the following detailed description and to the drawings, in which:

FIG. 1 schematically illustrates the anatomy of the internal jugular vein.

FIG. 2 schematically illustrates a scenario as a catheter is as being introduced in a retrograde direction through a valve.

FIGS. 3-5 illustrate intraluminal scaffolds and methods of use thereof for treating a condition of a vein according to one aspect of the disclosed subject matter.

FIGS. 6 through 9 illustrate methods of treating a condition of a vein according to another aspect of the disclosed subject matter, wherein FIG. 8 depicts a vein demonstrating a vein sac.

FIGS. 10 through 17 illustrate methods of forming an intraluminal scaffold having an enlarged portion according to a further aspect of the disclosed subject matter.

FIGS. 18 through 22 illustrate a method of treating a condition of a vein according to another aspect of the disclosed subject matter.

FIG. 23 depicts an intraluminal scaffold having an enlarged non-cylindrincal portion according to the disclosed subject matter.

FIG. 24 depicts an exemplary balloon suitable for deploying the stent depicted in FIG. 23.

FIGS. 25 through 26 illustrate certain embodiments of an intraluminal scaffold having a bistable construction according to one aspect of the disclosed subject matter.

FIGS. 27 through 37 illustrate various embodiments of an intraluminal scaffold including an enlarged portion according to the disclosed subject matter.

FIGS. 38 through 41 illustrate various embodiments of an intraluminal scaffold having one or more generally axial struts according to another aspect of the disclosed subject matter.

FIGS. 42 through 44 schematically illustrate a catheter device and an associated method suitable for deploying a medical device across a valve according to one aspect of the disclosed subject matter.

FIGS. 45 through 47 illustrate a catheter device and an associated method suitable for deploying a medical device across a valve according to another aspect of the disclosed subject matter.

FIGS. 48 through 49 illustrate non-target vessel occlusion to dilate target vessel valves according to one embodiment of the disclosed subject matter.

FIGS. 50 through 51 illustrate a method of accessing veins through the neck according to one embodiment of the disclosed subject matter.

FIGS. 52 through 56 illustrate a telescoping catheter and a method of use thereof for deploying a medical device according to one aspect of the disclosed subject matter.

FIGS. 57 through 59 illustrate a catheter device having an expandable cuff and the associated method for opening a valve according to one aspect of the disclosed subject matter.

DETAILED DESCRIPTION

While the disclosed subject matter may be embodied in many different forms, reference will now be made in detail to specific embodiments of the disclosed subject, examples of which are illustrated in the accompanying drawings. This description is an exemplification of the principles of the disclosed subject matter and is not intended to limit the subject matter to the particular embodiments illustrated.

In accordance with one aspect of the disclosed matter, an intraluminal scaffold is provided which is suitable to be implanted in a body lumen, such as a blood vessel or the like, e.g., a vein, of a patient. In general, the construction of the intraluminal scaffold can be selected such that the scaffold, or a portion thereof, can either support or conform to a body lumen. By “conforming,” when the term relates to a scaffold of a portion thereof, it is intended that the overall geometry and stiffness of the scaffold, or relevant portion thereof, are such that the scaffold (or the portion thereof) can engage the lumen wall to inhibit movement of the scaffold within the lumen under the normal use conditions without substantially altering the diameter of the lumen from its undisturbed or natural state prior to implanting the scaffold. However, the conforming scaffold can be suitably sized and flexible to maintain engagement with the vessel wall in response to a change in the diameter of the vessel between its smallest diameter to its maximum anticipated diameter corresponding to different physiological states of the patient. The conforming scaffold does not urge or otherwise support the lumen wall in a predetermined diameter, but rather dynamically changes its shape to adapt to the varying size of the lumen (e.g., a blood vessel) at different anatomical sites and in different physiological conditions, and this allows for easy deployment, retrieval, and repositioning of the conforming scaffold within the blood vessel. In contrast, a supporting scaffold is usually configured for maintaining the patency of a vessel, such as an artery, and is greater in radial strength and stiffness. The scaffolds disclosed herein can be either a supporting scaffold or conforming scaffold, or include portions that have the characteristics of either a supporting scaffold or a conforming scaffold. Thus, the term “scaffold” encompasses “stent,” and the two terms are used interchangeably herein. The scaffolds or stents described herein can include structural patterns used for conventional stents such as those formed by a series of longitudinally arranged rings formed by interconnected struts and connected with longitudinal connectors. However, the structural elements of the scaffolds or stents of the disclosed matter are not restricted to the struts or connectors or traditional stents, but likewise include flexible or pliant filaments, wire, and the like.

Accordingly, one aspect of the disclosed subject matter provides an intraluminal scaffold is provided. The intraluminal scaffold has a generally tubular body with a lumen defined therethrough, the tubular body having a compressed condition for delivery and an expanded condition for implant within a vessel having a distended portion. At least a length of the tubular body configured to form an enlarged portion in the expanded condition to engage a wall of the distended portion of the vessel. In another aspect, the disclosed subject matter provides a method of treating a condition of a vessel, such as a vein, which includes deploying such a scaffold within a distended portion of a vessel such that upon the deployment the enlarged portion engages a wall of the distended portion of the vessel. The enlarged portion can have a non-cylindrical shape. The vessel can be a vein, e.g., an internal jugular vein, wherein the vessel can have or is subject to a valve anomaly (e.g., one or more valves in the vein are malformed or malfunctional). This method will be described in conjunction with the intraluminal scaffold below, and it is understood the method is generally applicable for any of the various embodiments of the intraluminal scaffold described herein.

For illustration and not limitation, various embodiments of the intraluminal scaffold and related delivery systems of the disclosed subject matter are described below in connection with the drawings. It is noted that the figures are not to scale and certain dimensions have been exaggerated for clarity. Referring to FIG. 3, a stent 100 has a distal end enlarged portion 102 with an increased profile in an expanded condition (a bulbous portion is depicted for illustration purpose). This enlarged non-cylindrical portion can prevent the stent 100 from dislodging from the vein that it is deployed within. For example, the stent can be positioned within one of the internal jugular veins, wherein bulbous segment of the stent 100 will act to retain the stent within the veins. Veins are typically more elastic than arteries and thus may require additional anchoring to keep the stent 100 in place. The closely conforming feature of the stent in accordance with the disclosed subject matter may reduce thrombus formation within the vein, which may otherwise occur if a gap left between the stent and the vessel wall. The non-cylindrical portion as described herein can be embodied in many different geometrical configurations, for example the non-cylindrical portion may be embodied as a flared portion as shown in FIG. 4. Other geometrical configurations contemplated herein may have a conical or tapered appearance, or take other shapes as further described below.

As previously described, veins are more elastic than arteries. Even with the use of the anchoring techniques, it is possible that the stent could still dislodge when used in the venous system. Accordingly, stent 100 can be sized and configured to have an expansion profile that approximates the average diameter of the target vein and a total length that is sufficient to prevent the stent from being dislodged into the brachiocephalic veins, in the event of stent dislodgment. The stent length (L) can be at least as long as the diameter (D) of the brachiocephalic vein at the ostium of the target vein. Alternatively, the stent length can be 2-4 times that diameter. This feature is illustrated further in FIG. 5. For example and not limitation, stent 100 can have radial strength tuned to the properties of the target vein. Since the elasticity of the vein is greater, the stent 100 can be a conforming stent rather than a supporting stent.

Access to the target veins that include the most anatomical abnormalities can be accomplished in a number of manners. In order to access the right internal jugular with a larger profile stent, a catheter can be delivered through and tracked the inferior vena cava. Once near the jugular, the catheter can be advanced directly into the right internal jugular vein from the superior vena cava, or it can be advanced into the left internal jugular via the brachiocephalic vein. Alternatively, when using a small profile stent delivery system, e.g. with a balloon expandable stent, access can be made through the subclavian vein in the wrist. A delivery catheter can then be tracked to the right internal jugular vein, or it can be advanced into the left internal jugular vein via the brachiocephalic vein.

The stent 100 can be formed from various materials. For example, the stent 100 can be formed of a balloon expandable material such as stainless steel, silver, platinum, tantalum, palladium, cobalt-chromium alloys such as L605, MP35N, or MP20N, niobium, iridium, any equivalents thereof, alloys thereof, and combinations thereof. Alternatively, it can be a self-expandable stent material such as nickel-titanium, copper-zinc-aluminum, or copper-aluminum-nickel. In addition, the material can be a shape memory material, a polymeric material, a degradable material, e.g., a biodegradable material, a resorbable material, and the like. Further, different portions of the stent can be formed of different material.

The material can be selected according to target anatomy. If the target anatomy has a large diameter, it may be preferable to use a self-expanding stent that can accommodate large vessels. However, smaller veins may benefit more from balloon expandable stents. Also, considerations such as the target vessel elasticity can be taken into account. In cases where the vessel is more elastic, it may be preferable to use a self expanding stent, and vice versa.

In an alternative embodiment, the stent may have an integrated filter system. For example, a parachute basket can be attached to one or more stent rings such that deployment of the stent within a vein will cause the basket to canopy across the vein. Therefore, any thrombotic material that is dislodged during placement would travel into the basket and be captured, thereby preventing a thrombotic event. Alternatively, an embolic protection device may be used during stent deployment to capture any acute thrombus and remove it from the body following stent placement.

As described above, the enlarged portion of the stent can be use as an anchor to retain the stent within a body lumen, e.g., a vein. As illustrated in FIG. 27, the desired anchor point when treating CCSVI can be near the bulbous segment in the proximal area of the internal jugular vein. It will be appreciated that this location is selected for illustrative purpose only, and the stent can be positioned elsewhere.

As illustrated in FIG. 28, the enlarged portion can include a spiral-shaped element 172 used as an anchor to stabilize a stent 170 within a vein. An advantage of a spiral anchor is its ability to conform to a wide range of vessels without exerting excessive radial load to the vessel wall. The stent embodiment may include one portion 174 that comprises one or more typical stent rings 176. That is, the portion 174 can include a generally meandering stent ring pattern connected with adjacent stent rings. This portion 174 of the stent 170 can be positioned within the distal segment of the vein beyond the desired anchor point. The stent 170 will then be anchored in place by the spiral anchor 172 segment that is intended to be positioned within the bulbous segment of the vein. The spiral anchor 172 can be formed by one or more spiral elements 178 that extend in a proximal direction from the normal stent segment 174. The spiral segment(s) 178 may gradually increase in diameter, thereby ensuring that they will remain in contact with the distended vessel and anchor the stent 170 within the vessel.

In an alternative embodiment, multiple spiral anchor segments 172 can be used to provide greater apposition with the vessel and therefore better anchoring. The multiple spiral anchors 172 can be connected with one another, for example by attaching the spirals at their ends. Alternatively, they can be completely independent from one another. The spirals can be formed from the same tubing as the normal stent segment, or they can be formed separately and then added to the stent segment 174 through the use of welding or other bonding processes.

As shown in FIG. 36, a spiral anchor 240 having a bulbous profile can be used to anchor the stent 242 more particularly within a bulbous vein segment. One or more spiral anchors 240 can extend from the end 244 of the stent 242 and be formed in a spiral or curvilinear manner that first expands in diameter and then reduces in diameter. Thus, the spiral anchor 240 will conform to a bulbous segment of a vein.

Referring to FIG. 29A, the enlarged portion of the stent can be a bulbous anchor 180 to secure the stent 182 within a vein. The bulbous anchor can have a generally barrel shaped profile as depicted. The barrel shape can be the result of a shape memory effect introduced during stent manufacturing, or it can be the result of expansion by a barrel-shaped balloon. In either case, the stent design can provide that upon expansion, the individual cell area is approximately equivalent or uniform throughout the stent structure. In other words, even though individual rings across the stent structure have varying diameters, the intracellular area remains unaffected and therefore the vascular scaffolding is more consistent than would be the case if a typical stent design were deployed into a barrel shape. Further more, use of a barrel-shaped stent with more uniform cellular structure will provide more consistent radial strength over the stent length.

As shown in FIG. 29B, the stent can be particularly useful in the treatment of veins that are bulged or distended. This distension can occur, for example, near a venous valve. This is particularly true when the patient presents with venous insufficiency. It is notable that the bulging of the veins can be immediately adjacent to the valve, or the valve can be within the bulbous region. Often, the valve is stenosed and closed under these circumstances. Thus, in a method of using the stent (or any of the other stents described herein), the stent can be placed across the valve, wherein the stent may be placed across the valve where the stent is placed in only the distended region, or, in both the distended region and the valve segment.

Referring to FIG. 29C, in an alternative embodiment the stent can include only one, or very few, stent rings 290. In addition, the stent ring itself can be formed with a barrel shape. Therefore, each individual strut can be curved in a way that creates annulus having a barrel shape. The length of the struts can be varied depending on the design to produce a stent that is longer or shorter, for example. Deployment of a stent structure such as the one illustrated in FIG. 29C within a vessel can conform to or support a distended region with lower risk of dislodgment.

As shown in FIG. 30, the enlarged portion can include buttercup anchor for securing the stent 190 within a vein. The buttercup design contemplates that a segment 192 of the stent will be tapered outward. This flared portion 192 will have a larger profile or diameter (D) as compared to the diameter (d) of the normal stent segment 194. This structure creates an anchor that resists movement in at least two ways. First, the larger diameter D formed by the outwardly extending struts of the stent 190 is intended to provide some frictional load against the vein wall that resists dislodgment. Second, since the flared portion projects in a certain direction, it will preferentially resist motion because the flares will engage the tissue wall and expand even further if moved in the direction of the flare expansion.

FIGS. 31 and 32 illustrate a stent where the non-cylindrical shaped portion can include a branched portion. The branched portion can be formed by one or more annular rings of the stent protruding outward from the branch location forming a surface irregularity, or by a side branch in communication with a side opening of the stent. The branched portion can engage a vessel bifurcation in order to prevent stent dislodgment. FIG. 31 indicates an exemplary anatomy in the region of the internal jugular vein. There can be one or more collaterals or side branch veins that parallel the internal jugular vein. As shown in FIG. 32, these branches allow a stent 200 to be used with side branch segments 202 that can engage the collaterals. Once these collaterals are engaged, it is more difficult for the stent to dislodge because the dislodgment force exerted on the stent by the blood flow is resisted by the reaction force that the side branch vessels apply to the stent. Thus, the stent 202 is substantially more secure within the vein.

FIG. 33 shows a stent 210 showing a braided stent design that utilizes a restraining band 212 to produce a compressive load on the stent structure following deployment. This compressive load induces the formation of a bulging of the stent that creates an anchor point in the vessel. The restraining band 212 can be fabricated from an elastomeric material and bonded to the ends 214 and 216 of the stent 210 using a thermal or chemical bond. Alternatively, the band 212 can be mechanically restrained by inserting it and heat staking it within a groove or hole (not shown on FIG. 33) within the stent 210. In order to prevent the stent 210 from expanding prior to deployment, the stent can be delivered from a constraining tube, such as those used for self-expandable stents. Once deployed from the tube, the band 212 can be released and allowed to recoil and compress the stent to form the desired non-cylindrical shape. The band can also be made of a degradable or resorbable material, which can weaken over time to allow the stent to recoil to a smaller profile.



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Valve prosthesis fixation techniques using sandwiching
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stats Patent Info
Application #
US 20120046739 A1
Publish Date
02/23/2012
Document #
13087347
File Date
04/14/2011
USPTO Class
623/211
Other USPTO Classes
International Class
61F2/24
Drawings
27


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