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Method of delivering a medical device across a plurality of valves




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. ...


USPTO Applicaton #: #20120046739
Inventors: Randolf Von Oepen, Kevin J. Ehrenreich, Kelly J. Mccrystle


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

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

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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

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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.




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stats Patent Info
Application #
US 20120046739 A1
Publish Date
02/23/2012
Document #
File Date
12/31/1969
USPTO Class
Other USPTO Classes
International Class
/
Drawings
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20120223|20120046739|delivering a medical device across a plurality of valves|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 |