US 20060212068 A1
An elongated core member and an expandable frame for an embolic filtering device used to capture embolic debris in a body lumen. The expandable frame also includes a filtering element. A nickel-titanium alloy is used to form the frame, the elongated core member, or both the frame and the elongated core member. The nickel-titanium alloy includes at least one ternary element, such as iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium, so that the frame and/or elongated core member is also radiopaque.
1. An embolic protection device comprising:
an elongated core member having a proximal core section and a distal core section, said elongated core member comprising a superelastic nickel-titanium alloy wherein said superelastic nickel-titanium alloy comprises at least one ternary element, such that at least a portion of said elongated core member exhibits radiopacity.
2. The embolic protection device of
3. The embolic protection device of
4. The embolic protection device of
5. The embolic protection device of
6. The embolic protection device of
7. The embolic protection device of
8. The embolic protection device of
9. The embolic protection device of
10. A medical device comprising:
an elongated core member having a proximal core section and a distal core section, said elongated core member comprising a superelastic nickel-titanium alloy, wherein said superelastic nickel-titanium alloy comprises at least one ternary element, such that at least a portion of said elongated core member exhibits radiopacity; and
a filter coupled to the distal core section of said elongated core member.
11. The device of
12. The device of
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18. A medical device comprising:
an elongated core member having a proximal core section and a distal core section, wherein said elongated core member comprises a superelastic nickel-titanium alloy having a radiopaque material coated thereon; and
a filter coupled to the distal core section of said elongated core member.
19. The device of
20. The device of
21. An embolic protection device comprising:
an elongated core member having a proximal core section and a distal core section, wherein said elongated core member comprises a ternary superelastic nickel-titanium-platinum alloy such that at least a portion of said elongated core member exhibits radiopacity; and
a filter coupled to the distal core section of said elongated core member, wherein said filter comprises an expandable assembly having an expandable frame and a filter element coupled to the expandable frame.
This application is a continuation-in-part of U.S. patent application Ser. No. 10/427,576, filed May 1, 2003, which is incorporated herein by reference.
The present invention relates generally to filtering devices, core members for medical devices, and systems which can be used, for example, when an interventional procedure is being performed in a stenosed or occluded region of a body vessel to capture embolic material that may be created and released into the body fluid during the procedure. The present invention is also directed to an embolic filtering device made with a self-expanding frame (also referred to as a basket or cage) having good flexibility and bendability that is also radiopaque. In addition, the present invention is directed to an embolic protection filter having an elongated superelastic, radiopaque core member.
Numerous procedures have been developed for treating occluded blood vessels to allow blood to flow without obstruction. Such procedures usually involve the percutaneous introduction of an interventional device into the lumen of the artery, usually by a catheter. One widely known and medically accepted procedure is balloon angioplasty in which an inflatable balloon is introduced within the stenosed region of the blood vessel to dilate the occluded vessel. The balloon dilatation catheter is initially inserted into the patient's arterial system and is advanced and manipulated into the area of stenosis in the artery. The balloon is inflated to compress the plaque and press the vessel wall radially outward to increase the diameter of the blood vessel, resulting in increased blood flow. The balloon is then deflated to a small profile so that the dilatation catheter can be withdrawn from the patient's vasculature and the blood flow resumed through the dilated artery. As should be appreciated by those skilled in the art, while the above-described procedure is typical, it is not the only method used in angioplasty.
Another procedure is laser angioplasty which uses a laser to ablate the stenosis by superheating and vaporizing the deposited plaque. Atherectomy is yet another method of treating a stenosed body vessel in which cutting blades are rotated to shave the deposited plaque from the arterial wall. A catheter is usually used to capture the shaved plaque or thrombus from the bloodstream during this procedure.
In procedures of the kind referenced above, abrupt reclosure may occur or restenosis of the artery may develop over time, which may require another angioplasty procedure, a surgical bypass operation, or some other method of repairing or strengthening the area. To reduce the likelihood of the occurrence of abrupt reclosure and to strengthen the area, a physician can implant an intravascular prosthesis for maintaining vascular patency, commonly known as a stent, inside the artery across the lesion. The stent can be crimped tightly onto the balloon portion of the catheter and transported in its delivery diameter through the patient's vasculature. At the deployment site, the stent is expanded to a larger diameter, often by inflating the balloon portion of the catheter.
The above non-surgical interventional procedures, when successful, avoid the necessity of major surgical operations. However, there is one common problem which can become associated with all of these non-surgical procedures, namely, the potential release of embolic debris into the bloodstream that can occlude distal vasculature and cause significant health problems to the patient. For example, during deployment of a stent, it is possible that the metal struts of the stent can cut into the stenosis and shear off pieces of frangible plaque that can travel downstream and lodge somewhere in the patient's vascular system. Pieces of plaque are sometimes generated during a balloon angioplasty procedure and released into the bloodstream. This is particularly true when the procedure is performed in a saphenous vein graft (SVG).
Additionally, while complete vaporization of plaque is the intended goal during laser angioplasty, sometimes particles are not fully vaporized and enter the bloodstream. Likewise, not all of the emboli created during an atherectomy procedure may be drawn into the catheter and, as a result, enter the bloodstream.
When any of the above-described procedures are performed in the carotid arteries, the release of emboli into the circulatory system can be extremely dangerous and sometimes fatal to the patient. Debris carried by the bloodstream to distal vessels of the brain can cause cerebral vessels to occlude, resulting in a stroke, and in some cases, death. Therefore, although cerebral percutaneous transluminal angioplasty has been performed in the past, the number of procedures performed has been somewhat limited due to the justifiable fear of an embolic stroke occurring should embolic debris enter the bloodstream and block vital downstream blood passages.
Medical devices have been developed to address the problem created when debris or fragments enter the circulatory system following vessel treatment using any one of the above-identified procedures. One approach is to cut the debris into minute sizes which pose little chance of becoming occluded in major vessels within the patient's vasculature. However, it is often difficult to control the size of the fragments that are formed. So the potential risk of vessel occlusion still exists, making such a procedure in the carotid arteries a high-risk proposition.
Other techniques include the use of catheters with a vacuum source that provides temporary suction to remove embolic debris from the bloodstream. On the other hand, there can be complications associated with such systems if the vacuum catheter does not remove all of the embolic material from the bloodstream. Also, a powerful suction could cause trauma to the patient's vasculature.
Another technique which has had some success deploys a filter or trap downstream from the treatment site to capture embolic debris before they reach the smaller blood vessels downstream. The placement of a filter in the patient's vasculature during treatment of the vascular lesion can reduce the presence of the embolic debris in the bloodstream. Such embolic filters are usually delivered in a collapsed position through the patient's vasculature and then expanded to trap the embolic debris. Some of these embolic filters are self-expanding and rely on a restraining sheath that maintains the expandable filter in the collapsed position until it is ready to be expanded at the target site within the patient's vasculature. At the target site, the physician retracts the proximal end of the restraining sheath to expose the expandable filter, allowing the filter to self-expand at the desired location. Once the procedure is completed, the filter can be collapsed. The filter with the trapped embolic debris can then be removed from the vessel.
While a filter can be effective in capturing embolic material, the filter still needs to be collapsed and removed from the vessel. During these steps, there is a possibility that trapped embolic debris can backflow through the inlet opening of the filter and re-enter the bloodstream. Therefore, it is important that any captured embolic debris remain trapped within the filter so that particles are not inadvertently released back into the body vessel.
Some prior art expandable filters are attached to the distal end of a guide wire or guide wire-like member which allows the filtering device to be steered in the patient's vasculature as the guide wire is positioned by the physician. Once the guide wire is in proper position in the vasculature, the embolic filter is deployed to capture embolic debris. The guide wire can then be used by the physician to deliver interventional devices, such as a balloon angioplasty dilatation catheter or a stent delivery catheter, to perform the interventional procedure in the area of treatment. After the procedure is completed, a recovery sheath is delivered over the guide wire using over-the-wire techniques to collapse the expanded filter for removal from the patient's vasculature.
When a combination of an expandable filter and a guide wire is used, the expandable filter portion should be flexible in order to negotiate the often tortuous anatomy through which it is being delivered. An expandable filter that is too stiff could prevent the device from reaching the desired deployment position within the patient's vasculature. As a result, there is a need to increase the flexibility of the expandable filter without compromising its structural integrity once in position within the patient's body vessel. Also, while it is beneficial if the area of treatment is located in a substantially straight portion of the patient's vasculature, sometimes the area of treatment is at a curved portion of the body vessel which can be problematic to the physician when deploying the expandable filter. If the expandable filter portion is too stiff, it is possible that the filter may not fully deploy within the curved portion of the body vessel. As a result, gaps between the filter and vessel wall can form that may permit some embolic debris to pass therethrough.
Therefore, the filtering device should be sufficiently flexible to be deployed in, and to conform to, a tortuous section of the patient's vasculature when needed.
Expandable filters can be provided with some increased flexibility by forming the struts of the filter assembly from relatively thin material. The use of thin material, however, often reduces the radiopacity of the expandable filter. This often makes it difficult for the physician to visualize the filter during deployment.
Conversely, the use of thicker materials, which can promote radiopacity of the expandable filter, usually reduces its flexibility and may impair the deliverability of the expandable filter within the patient.
In addition, nickel-titanium alloys have been used to make embolic filters and elongated core members, such as guide wires. Visualization of these filters and elongated core members, however, is difficult during fluoroscopy, because the nickel-titanium alloys from which these devices are made exhibit relatively low radiopacity as compared to other metallic materials.
What is needed is an expandable filter assembly having high flexibility with sufficient strength and radiopacity to be successfully deployed within a patient's vasculature to collect embolic debris. In addition, an elongated core member having sufficient radiopacity to be visible during fluoroscopy would be beneficial. The present invention disclosed herein satisfies these and other needs.
The present disclosure provides an embolic protection device including an elongated core member having a proximal core section and a distal core section. The elongated core member is partially or totally formed from a superelastic nickel-titanium alloy. This superelastic nickel-titanium alloy further includes, by alloy addition, at least one ternary element, such that at least a portion of the elongated core member exhibits radiopacity. In lieu of or addition to the aforementioned alloys, all or a portion of the elongated core member may be coated, e.g. by plating, vapor deposition etc., with at least one ternary element, such that at least a portion of the elongated core member exhibits radiopacity. As used herein, the terms “radiopacity,” “radiopaque,” or radiopaque component”are defined as the ability to be visualized via fluoroscopy while in a body lumen.
Non-limiting examples of ternary elements which may be utilized according to the present disclosure include iridium, platinum, palladium, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, hafnium, and combinations thereof. In a non-limiting embodiment of the present disclosure, the at least one ternary element is chosen from platinum, palladium, tungsten, and combinations thereof. In a further non-limiting embodiment, the at least one ternary element is platinum.
In one embodiment, the at least one ternary element may be present in the superelastic nickel-titanium alloy in an amount ranging from greater than 0 to about 20 atomic %. In a non-limiting embodiment of the present disclosure, the at least one ternary element is present in the superelastic nickel-titanium alloy in an amount ranging from greater than 0 to about 10 atomic %.
In addition, the elongated core member described herein may be formed such that it is partially or entirely radiopaque. For example, both the proximal portion and distal portion of the elongated core member may be formed so as to exhibit radiopacity. Alternatively, only a portion of the elongated core member, e.g. only the distal core section, may be formed so as to exhibit radiopacity. In a further non-limiting embodiment, the radiopacity of the superelastic-nickel titanium alloy that includes at least one ternary element as described above, is greater than that of binary nickel-titanium. An elongated core member comprising a superelastic-nickel titanium alloy may also be coated with such an element to increase the radiopacity of the core member to greater than an uncoated core member or a binary nickel-titanium.
The embolic protection device disclosed herein may comprise an expandable filter assembly having an expandable frame and a filter element coupled to the expandable frame. In a non-limiting embodiment of the present disclosure, the expandable frame of the filter assembly at least partially covers the elongated core member while in an unexpanded state. In another non-limiting embodiment of the present disclosure, the portion of the elongated core member that is at least partially covered by the filter assembly exhibits radiopacity. In a further non-limiting embodiment of the present disclosure, the portion of the elongated core member that is at least partially covered by the filter assembly comprises a superelastic nickel-titanium alloy that includes, by alloy addition, coating or otherwise, at least one element, as described above.
In a further non-limiting embodiment, the present disclosure provides an embolic protection device that includes an elongated core member having a proximal core section and a distal core section. The elongated core member comprises a ternary superelastic nickel-titanium-platinum alloy, such that at least a portion of the elongated core member exhibits radiopacity. In addition, a filter is coupled to the distal core section of the elongated core member. The filter includes an expandable assembly having an expandable frame and a filter element coupled to the expandable frame.
The present invention further provides a medical device that includes an elongated core member having a proximal core section and a distal core section. The elongated core member of this medical device includes, by alloy addition, coating, or otherwise, at least one ternary element, such that at least a portion of the elongated core member exhibits radiopacity. As used herein, the term “at least one ternary element” means that the medical device includes one or more additional elements other than nickel and titanium, such as 4 or 5 elements, by alloy addition, coating, or otherwise. Thus, “at lest one ternary element” is inclusive of ternary, quaternary, quintary, etc. additions.
Non-limiting examples of the at least one ternary element that may be utilized in the above described medical device include those ternary elements described above. In a non-limiting embodiment, the at least one ternary element is chosen from platinum, palladium, tungsten, and combinations thereof. In a further non-limiting embodiment, the at least one ternary element is platinum. If the at least one ternary element is added via alloy addition, it may be present in the superelastic nickel-titanium alloy in the amounts specified above. In a further non-limiting embodiment, the radiopacity of the superelastic-nickel titanium alloy that includes, by alloy addition, coating, or otherwise, at least one ternary element as described above, is greater then that of binary nickel-titanium.
In a non-limiting embodiment of the present disclosure, a filter is coupled to the distal core section of the elongated core member. This filter may include, for example, an expandable frame and a frame coupled to the expandable frame. In a further non-limiting embodiment, the expandable frame at least partially covers the elongated core member in an unexpanded state. In a further non-limiting embodiment of the present disclosure, the portion of the elongated core member that is at least partially covered by the expandable frame comprises a superelastic nickel-titanium alloy that further includes, by alloy addition, coating, or otherwise, at least one ternary element, as described above.
The elongated core member used in the above described medical device may be formed such that it is partially or entirely radiopaque. In a non-limiting embodiment, only the distal core section of the elongated core member exhibits radiopacity.
The present disclosure also provides a flexible self-expanding frame for use with an embolic filtering device designed to capture embolic debris created during the performance of a therapeutic interventional procedure, such as a balloon angioplasty or stenting procedure, in a body lumen. The present disclosure provides the physician with an embolic filtering device having the flexibility needed to be steered through tortuous anatomy, yet possessing sufficient strength to hold open a filtering element against the wall of the body lumen for trapping embolic debris. Also, the present disclosure provides sufficient flexibility without compromising the radiopacity characteristics of the filtering device. Thus, an embolic filtering device made in accordance with the present disclosure is radiopaque, relatively easy to deploy, and has good flexibility and conformability to the patient's anatomy.
In one embodiment, an embolic filter assembly of the present disclosure includes an expandable frame made from a self-expanding material, such as linear elastic nickel-titanium (NiTi or nitinol). The frame may be made, for example, from a pair of half frames capable of expanding from an unexpanded position having a first delivery diameter to an expanded or deployed position having a second expanded diameter. A filter element made from an embolic-capturing material is attached to the expandable frame to move between the unexpanded position and deployed position.
The half frames which cooperatively form the expandable frame can be set to remain in the expanded, deployed position until an external force is placed over the half frames to collapse and move the frames to the unexpanded position. One way of accomplishing this is through the use of a restraining sheath, for example, which can be placed over the filtering device in a coaxial fashion to contact the half frames and move the half frames into the unexpanded position.
The embolic filtering device can be attached to the distal end of an elongated core member, such as a guide wire, for temporary placement in the vasculature. This elongated core member may be used in conjunction with the filtering device when embolic debris is to be filtered during, for example, an interventional procedure. In this manner, the elongated core member and filtering assembly, with the restraining sheath placed over the filter assembly, are introduced into the patient's vasculature. Once the physician manipulates the elongated core member into the target area, the restraining sheath is retracted to deploy the expandable frame into the expanded position. This can be easily performed by the physician by simply retracting the proximal end of the restraining sheath located outside of the patient. Once the restraining sheath is retracted, the self-expanding properties of the frame cause each half frame to move in an outward, radial fashion away from the elongated core member to contact the wall of the body vessel. As the half frames expand radially, so does the filter element, which is now maintained in place to collect embolic debris that may be released into the bloodstream as the physician performs the interventional procedure. The elongated core member is also used by the physician to deliver the necessary interventional device into the area of treatment.
The present disclosure also contemplates an embolic filter having a frame and/or an elongated core member made from a linear elastic alloy. In a non-limiting embodiment, the alloy is nickel-titanium, also known as Ni—Ti or nitinol. Linear elastic nitinol exploits a shape setting capability without eventually developing stress-induced martensite. This linear elastic alloy may be formed, for example, by cold forming the alloy to achieve its intended shape, with optional, limited heat treatment such that no stress plateau appears in the stress-strain curve of the alloy. Indeed, when positioned inside the body lumen, linear elastic NiTi is in the martensitic phase only, and does not undergo a phase change when stressed.
In another non-limiting embodiment of the present disclosure, either or both of the frame and elongated core member include a linear elastic NiTi alloy that is further alloyed with greater than 0 to 10 atomic % of at least one ternary element selected from the group of elements consisting of iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, hafnium, or combinations thereof. Addition of one or more of these elements to the binary nickel-titanium alloy enables the nickel-titanium alloy frame and/or elongated core member to become radiopaque. In a non-limiting embodiment of the present disclosure, the linear elastic nickel-titanium that further includes at least one of the aforementioned ternary elements produces a frame or elongated core member that is appreciably more radiopaque than an identical frame or elongated core member made only from binary nickel-titanium. Alternatively, either or both of the frame and the elongated core member may be made radiopaque by coating, e.g. by plating, vapor depositing, etc... at least one of the aforementioned ternary elements on the frame and/or elongated core member.
The addition or use of at least one ternary element improves radiopacity yet does not detract from the engineering qualities of the nickel-titanium alloy. Indeed, the nitinol described herein remains highly elastic as compared to steel.
The embolic filter according to the present disclosure is useful when an interventional procedure, such as balloon angioplasty, stenting procedure, laser angioplasty or atherectomy, is performed in a critical body lumen, such as the carotid arteries, where the release of embolic debris into the bloodstream can occlude the flow of oxygenated blood to the brain, resulting in grave consequences to the patient. Of course, the embolic filter may be used in conjunction with any vascular procedure in which embolic risk is present.
The present invention can be used in arteries, veins, and other body vessels. It is to be understood that the present invention is not limited by the embodiments described herein. Other features and advantages of the present invention will become more apparent from the following detailed description of the invention when taken in conjunction with the accompanying exemplary drawings.
Turning now to the drawings, in which like reference numerals represent like or corresponding elements in the drawings,
Elongated core member 28 has a proximal core section and a distal core section. In one non-limiting embodiment of the present disclosure, elongated core member 28 comprises a superelastic nickel-titanium alloy that is alloyed with greater than 0 to 20 atomic %, such as from greater than 0 to 10 atomic % of at least one ternary element such that at least a portion of elongated core member 28 exhibits radiopacity. In another non-limiting embodiment, elongated core member 28 may comprise a nickel titanium alloy that has been coated, e.g. by plating, vapor deposition etc., with at least one ternary element, such that at least a portion of elongated core member 28 exhibits radiopacity. For example, elongated core member 28, which has a proximal core section and a distal core section, may be alloyed or coated with at least one ternary element such that only the distal section exhibits radiopacity. Alternatively, both the proximal and distal core sections of elongated core member 28, or any other portion thereof, may be made radiopaque by alloy addition or coating as set forth above.
The expandable filter assembly 22 can be deployed by the physician by simply retracting the restraining sheath 30 proximally to expose the expandable filter assembly. Once the restraining sheath is retracted, the self-expanding wire frame 24 becomes uncovered and immediately begins to expand within the body vessel (see
An optional obturator 32 is affixed to the elongated core member 28 distal to the filter assembly 22 to prevent possible “snowplowing” of the embolic filtering device as it is being delivered through the vasculature. The obturator 32 can be made from a soft polymeric material, such as PEBAX 40D, and and may have a smooth surface to help the embolic filtering device 20 travel through the body vessels and cross lesions while preventing the distal end of the restraining sheath 30 from “digging” or “snowplowing” into the wall of the body vessel. The end of the delivery sheath 30 may partially extend over the obturator 32 (
The expandable frame 24 may include a pair of half frames 42 and 44 (also referred to as D-frames) which, upon release from the restraining sheath 30, expand the filter element 26 into its deployed position within the artery (
After the dilatation catheter is removed from the patient's vasculature, a stent (not shown) can be implanted in the area of treatment 36 using over-the-wire or rapid exchange techniques to help hold and maintain the patency of this portion of the artery 34. The stent also helps prevent restenosis from developing in the area of treatment. The stent could be delivered to the area of treatment on a stent delivery catheter (not shown) which is advanced from the proximal end of the guide wire to the area of treatment. Any embolic debris 41 created during this interventional procedure will be released into the bloodstream and will enter the filter element 26. Once the procedure is completed, the interventional device may be removed from the elongated core member. The filter assembly 22 thereafter can be collapsed and removed from the artery 34, taking with it any embolic debris trapped within the filter element 26. A recovery sheath (not shown) can be delivered over the elongated core member 28 to collapse the filter assembly 22 for removal from the patient's vasculature.
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The filtering assembly 22 is optionally rotatably mounted onto the elongated core member 28 via a filter support structure 58. This filter support structure 58 may be a filter coil 60, and provides a suitable amount of flexibility and bendability to the composite filter assembly as the device is being delivered through the sometimes tortuous paths leading to the area of treatment. As can be seen in
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In order to maintain a small crossing profile, the delivery sheath 30 should have a small diameter to create the small crossing profile, yet must be large enough to house the collapsed filtering assembly 22 therein. As can be seen in
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The D-shaped partial loops 50, 56 in this embodiment also include an optional radiopaque wire coil 74 that wraps around each partial loop to enhance the radiopacity of the device under fluoroscopy. Since nickel-titanium is used in some embodiments to create the frame 24 of the present invention, there may be a desire to increase the radiopacity of the device under fluoroscopy. Hence, a very small diameter wire 74 is wrapped around the partial loops forming the half frames to increase visualization of the device during fluoroscopy. One suitable material for this radiopaque wire is gold-plated tungsten wire having about 5-7% gold plating. The wire can have a diameter of about 0.0010±0.0002 inch, although the diameter can vary depending on the size of the expandable frame 24. It should be appreciated that other radiopaque markers and marking systems known in the art may be added to the filter assembly 22 in order to enhance visibility during fluoroscopy.
Although the various embodiments of the embolic filtering apparatus have been shown as being mounted between fittings attached to an elongated core member, the embodiments shown can be also deployed in an over-the-wire fashion as well. For example, an elongated core member, such as a steerable guide wire can be first initially steered into the target location by the physician. Thereafter, the embolic filtering assembly, which includes the expandable frame and filter element, can then be delivered to the target area in an over-the-wire fashion via the elongated core member.
The delivery sheath can extend over the embolic filtering assembly and be moved with the filter assembly over the elongated core member to the distal end of the elongated core member, where the filter assembly can then be deployed. Using this technique, it may be easier to first steer the elongated core member into the target area and thereafter deliver the filtering assembly into the target area using an over-the-wire technique. It should be appreciated that a fitting may be required on the elongated core member to hold and maintain the filtering assembly to the core member once the filtering assembly has been delivered to the distal end section of the elongated core member. Alternatively, the filter coil used in conjunction with the filter assembly may be connected with the distal coil wire of the elongated core member as a means for holding the filter assembly in place. The filter coil could have a coil which is wound opposite the coil of the elongated core member to allow some intermeshing of the components in order to maintain the filtering assembly stationary on the elongated core member. Thereafter, once the interventional procedure has been performed, a recovery sheath recovers the filter assembly.
The expandable frames of the present invention can be made in many ways. One way is to use a single wire made from a material possessing highly elastic or shape memory properties. The wire can be fashioned then preset to deploy into a desired three-dimensional size and shape. The deployment would be triggered by the material's elasticity or shape memory.
Another method of making the frame is to cut a tubular-shape pattern from a self-expanding material, such as nickel-titanium. The cutting process removes portions of the tubing in the desired pattern for each half frame or full frame, leaving relatively untouched the portions of the tubing that are to form the control arms and partial loop(s). The tubing may be cut into the desired pattern by means of a machine-controlled laser. Prior to laser cutting the pattern, the tubular member could be formed with varying wall thicknesses which can be used to create flexing portions on the half frames. The frame can also be fashioned from braided filaments similar in construction to rope.
The tubing, wire, or filaments used to make the frames may be made of biocompatible material such as nickel-titanium, spring steel, or the like. Elgiloy is another material which could possibly be used to fabricate the frames. Also, highly elastic polymers can be used to form the frames.
The filter size is often very small, so the wire, tubing, or braid from which the half frames are made typically have a small diameter. For example, the tubing has an outer diameter on the order of about 0.020-0.5 inch in the deployed condition. The wall thickness of the tubing is usually about 0.076 mm (0.003-0.006 inch). The diameter of a wire that can be used to form the expandable frame can be as small as about 0.0036 inch. Of course, large diameter wire could be used as well.
When multiple stranded or braided wire is used, the diameter of the composite wire can be about 0.006 inch. In a non-limiting embodiment of the present disclosure, the width and/or thickness at the strain distributing strut is small.. For frames implanted in body lumens, such as PTA applications, the dimensions of the tubing may be correspondingly larger.
Generally, when the frame or half frame is laser cut, the tubing is put in a rotatable collet fixture of a machine-controlled apparatus for positioning the tubing relative to a laser. According to machine-encoded instructions, the tubing is then rotated and moved longitudinally relative to the laser which is also machine-controlled. The laser selectively removes the material from the tubing by ablation and a pattern is cut into the tube. The tube is therefore cut into the discrete pattern of the finished frame. The frame can be laser cut much like a stent is laser cut. Details on how a tubing can be cut by a laser are found in, for example, U.S. Pat. No. 5,759,192 (Saunders), U.S. Pat. No. 5,780,807 (Saunders) and U.S. Pat. No. 6,131,266 (Saunders), which have been assigned to Advanced Cardiovascular Systems, Inc.
In general, the process of cutting a pattern for the frame out of the tubing is automated except for loading and unloading the length of tubing. For example, a pattern can be cut in tubing using a CNC-opposing collet fixture for axial rotation of the length of tubing in conjunction with CNC X/Y table to move the length of tubing axially relative to a machine-controlled laser as described. The entire space between collets can be patterned using the CO2 or Nd:YAG laser set-up. The program for control of the apparatus is dependent on the particular configuration desired and the pattern to be ablated in the coding.
In one example, the frame of the present invention can be laser cut from a tube of nickel-titanium whose transformation temperature is below body temperature. After the pattern of each frame is cut into the hypotube, the tubing is expanded and heat treated to be stable at the desired final diameter. Alternatively, the frames can be made from nitinol wire with the shape of the frames being set via techniques known in the art. The heat treatment also can control the transformation temperature of the frame such that it is superelastic at body temperature if so desired.
The frame is made to an expanded diameter size that is larger than the inside diameter of the target vessel. In this way the self-expanding control arms apply an outward radial force to the vessel wall. The nickel-titanium can be processed so that it exhibits non-linear pseudoelasticity (i.e., superelasticity) and self-expands upon deployment as described above. Specifically, the frame is heat set to self-expand to this larger diameter.
The frame of the present disclosure remains in its open position while at body temperature and can be manipulated into its unexpanded position upon application of a low temperature. One method allows the frame to undergo a phase change which would facilitate the frame and filter element being inserted into the restraining sheath. Lowering the temperature is accomplished by chilling the filter assembly in a cooling chamber maintained at a temperature such as below the martensite finish temperature by exposure to liquid nitrogen. Once the frame, or more precisely, the control arms, are manipulated into their collapsed state, the restraining sheath can be placed over the frame to prevent the arms from expanding once the temperature is brought up to room temperature, which is usually above the austenite start temperature (As).
Alternatively, the present invention frame is fabricated by laser cutting a large diameter tubing of nickel-titanium. The large diameter tubing creates a frame already in its expanded state. The frame is manipulated into its unexpanded position by squeezing and then backloading the frame into a restraining sheath, which keeps the frame in the unexpanded position until it is ready for use. If the frame is formed in this manner, there is no need to heat set the tubing to the final expanded diameter. This process of forming the frame can be applied to either superelastic or shape-memory nickel-titanium.
The present disclosure further seeks to preserve the engineering qualities of nickel-titanium alloys just described above yet improve upon the material's radiopacity by addition of a ternary element. In a non-limiting embodiment, this may be accomplished by forming a composition comprising about 30 to about 52 atomic percent titanium, up to 20 percent of one or more additional ternary alloying elements, and the balance nickel. Such ternary alloying elements may be chosen from iridium, platinum, gold, rhenium, tungsten, palladium, rhodium, tantalum, silver, ruthenium, or hafnium. In a non-limiting embodiment, the atomic percentage of platinum is greater than or equal to 2.5 and less than or equal to 15. In a further non-limiting embodiment, the atomic percentage of palladium is greater than or equal to 2.5 and less than or equal to 20.
In another non-limiting embodiment of the present disclosure, a frame or elongated core member is made from an alloy having approximately 42.8 atomic percent nickel, 49.7 atomic percent titanium, and 7.5 atomic percent platinum. Through empirical studies, the aforementioned composition can produce a tubular structure having a level of radiopacity that is comparable to the same size and pattern of a tubular structure made from 316 L stainless steel with a 2.7 to 6.5 μm gold coating.
In various alternative embodiments, the present disclosure contemplates the minor addition of a quaternary element, for example, iron, to further enhance the alloy's formability or its thermomechanical properties. The presence of impurities such as carbon or oxygen or the like in the present invention alloy is also possible. Further, instead of or in addition to alloy addition, as described above, the frame or elongated core member according to the present disclosure may be constructed of a nickel titanium alloy that has been coated, e.g. by plating, vapor deposition etc. with at least one of the aforementioned ternary elements.
One method of fabricating a linear elastic, radiopaque metallic frame according to the present disclosure entails first fashioning nickel-titanium tubing. Similar steps may be used to fashion wire as well. In this example, the tubing is made from vacuum induction melting nickel and titanium with the ternary element according to the compositions suggested above. The ingot is then remelted for consistency. The ingot is next hot rolled into bar stock, then straightened and sized, and hot or cold formed into a cylinder. The cylinder is gun drilled to form the tubing.
Instead of gun drilling, other methods of material removal known in the art may be used, including electric discharge machining (EDM), laser beam machining, and the like. Next, the tubing is cold drawn and annealed repeatedly to achieve the finished dimensions. The final reduction sequence should be between 20 to 50 percent cold work followed by no subsequent heat treatment. The cold drawing process involves reducing the diameter by drawing through a sequence of smaller diameter dies. The tube reduction process may include a mandrel over which the tube can be drawn. Of course, those skilled in the art understand that other methods of cold drawing small diameter tubing can be employed.
The following are additional processing guide posts for the present disclosure to achieve a sufficiently radiopaque frame yet maintain the engineering stress-strain characteristics of the alloy. Empirical evidence suggests that, in various embodiments, a Ni—Ti—Pd or Ni—Ti—Pt ingot should have the following austenite finish temperature (Af): 0 degrees C.≦Af≦40 degrees C. The Ni—Ti—Pd or Ni—Ti—Pt tubing or wire should exhibit an austenite start temperature of: −15 degrees C.≦As≦15 degrees C. In an exemplary embodiment, the final laser cut Ni—Ti—Pd or Ni—Ti—Pt frame should exhibit an austenite finish temperature of: 0 degrees C.≦Af≦37 degrees C. Of course, the Af of the finished laser cut frame can be set as needed by limited heat treating processes known in the art.
It is understood that the austenite finish temperature (Af) is defined to mean the temperature at which the material completely reverts to austenite. In technical terms, the Af (and other transformation temperatures As, Ms, Mf) as it applies to an ingot made of Ni—Ti—Pd or Ni—Ti—Pt, for example, is determined by a Differential Scanning Calorimeter (DSC) test, known in the art. The DSC test method to determine transformation temperatures for the ingot is guided by ASTM standard no. F 2004-00, titled “Standard Test Method For Transformation Temperature Of Nickel-Titanium Alloys By Thermal Analysis.”
The “active Af for the tubing or wire and the finished device is determined by a bend and free recovery test, also known in the art. In such a test, the tubing or wire is cooled to under the Mf temperature, deformed, and warmed up. While monitoring the increasing temperature, the point of final recovery of the deformation in the tubing approximates the Af of the material. The active Af testing technique is guided by a second ASTM standard titled “Standard Test Method For Determination Of Transformation Temperature Of Nickel-Titanium Shape Memory Alloys By Bend And Free Recovery,” or by equivalent test methods known in the art.
Samples of wire made in accordance with the foregoing exemplary embodiments were tested. Specifically, the stress-strain relationship based on empirical data for nickel-titanium-palladium and nickel-titanium-platinum are plotted against binary nitinol in
As is apparent from the plot of
The present disclosure further provides a nitinol wire or tube having improved radiopacity without reliance on increasing the wall thickness or strut thickness of the filter frame. Increasing wall or strut thicknesses detracts from the flexibility of the filtering device, which is detrimental to deliverability. Rather, the present invention radiopaque filter has a thin wall/strut thickness and/or strut cross-sectional area akin to a conventional stainless steel tube, and has comparable radiopacity to a stainless steel tube with a thin coating of gold. The wall/strut thickness is defined by the difference between the inside diameter and the outside diameter of the tube.
Moreover, conventional embolic filters and elongated core members rely on nickel-titanium alloy frames. Nickel-titanium is not known as a radiopaque material. The frame and/or elongated core member of the present disclosure includes a nickel-titanium alloy that includes, by alloy addition of a ternary element or coating, e.g. by plating or otherwise, at least one radiopaque element. The addition of the at least one ternary renders the device radiopaque. This benefits the physician by enabling him or her to clearly visually locate the filter assembly downstream from the site of the ongoing interventional procedure.
In another non-limiting embodiment, the frame and/or elongated core member of the present disclosure includes the radiopaque nitinol alloy described above, wherein the alloy is fashioned such that it behaves linear elastically inside a patient's body lumen. For example the laser cut nitinol tubing may be cold formed and/or cold worked with no heat treatment, such that it remains in a fully martensitic state in the body lumen. The cold working proceeds only at temperatures below the recrystallization temperature of the nitinol alloy. Next, the laser-cut nitinol tubing is cold worked to its desired expanded size. The desired expanded size is thus imparted or set into the laser cut tube.
When a linear elastic NiTi alloy is desired, the laser-cut nitinol tubing is not heat treated to prevent generation of any loading or unloading plateaus in the stress-strain curve. In an alternative embodiment, the nitinol tubing may undergo limited heat treating for only very short durations at low temperatures. The present disclosure recognizes that a significant difference between linear elasticity and non-linear pseudoelasticity is the absence or presence, respectively, of stress-induced martensite. It also recognizes that in order to set a particular shape in nitinol, the nitinol must be heat treated at a relatively high temperature for a short period of time. Under normal circumstances, this material would then exhibit non-linear pseudoelasticity and therefore would undergo a reversible phase transformation from austenite to martensite. When setting a shape under standard conditions, for example, 550 degrees C. for 5 minutes, the nitinol exhibits essentially no springback; that is, its unconstrained shape after heat treatment is nearly identical to its constrained shape during heat treatment. The nitinol does not spring back to its original shape prior to heat treatment. At the other extreme, linear elastic nitinol with no heat treatment has 100 percent springback and always returns to its original, cold worked shape.
Springback is a continuous function between no heat treatment (100 percent springback) and ideal shape setting heat treatment (approximately zero percent springback). From an engineering perspective for design of nitinol based pseudoelastic devices, less springback is sometimes more favorable than more springback. However, in some circumstances, linear elasticity may be preferable to non-linear pseudoelasticity. Therefore, the present invention, in addition to contemplating cold-worked only nitinol, addresses that regime of heat treatment temperatures and times within which springback is adequately minimized to successfully impart a desired shape to the nitinol structure and within which the nitinol does not develop a stable and reversible martensitic phase.
In a non-limiting embodiment of the present disclosure, to achieve the linear elastic behavior, the binary nickel-titanium tubing has approximately 55.8 atomic percent nickel. The tubing may contain approximately 38 percent cold working when measured by the reduction in cross-sectional area, and there is not to be any heat treatment following final cold reduction. As to the alternative embodiment, the present invention contemplates accumulated heat treatment of the tubing of up to 300 degrees C. for up to 5 minutes. Under ideal conditions, these process parameters should adequately ensure that the nitinol remains martensitic without a phase change under stress.
In a further non-limiting embodiment of the present disclosure, the elongated core member may be manufactured such that it exhibits non-linear pseudoelasticity. That is, the elongated core member may be manufactured such that it exhibits a hysteresis curve approximating that of the idealized curve shown in
To illustrate the foregoing points,
In curve A, when stress is applied to a specimen of a metal such as nitinol exhibiting non-linear pseudoelastic characteristics at a temperature at or above that which the transformation of the martensitic phase to the austenitic phase is complete, the specimen deforms elastically until it reaches a particular stress level where the alloy then undergoes a stress-induced phase transformation from the austenitic phase to the martensitic phase (i.e., the stress-induced martensite phase). As the phase transformation progresses, the alloy undergoes significant increases in strain with little or no corresponding increases in stress. On curve A this is represented by upper, nearly flat stress plateau at approximately 70 to 80 ksi. The strain increases while the stress remains essentially constant until the transformation of the austenitic phase to the martensitic phase is complete. Thereafter, further increase in stress is necessary to cause further deformation. The martensitic metal first yields elastically upon the application of additional stress and then plastically with permanent residual deformation (not shown).
If the load on the specimen is removed before any permanent deformation has occurred, the martensite specimen elastically recovers and transforms back to the austenitic phase. The reduction in stress first causes a decrease in strain. As stress reduction reaches the level at which the martensitic phase transforms back into the austenitic phase, the stress level in the specimen remains essentially constant (but less than the constant stress level at which the austenitic crystalline structure transforms to the martensitic crystalline structure until the transformation back to the austenitic phase is complete); i.e., there is significant recovery in strain with only negligible corresponding stress reduction. This is represented in curve A by the lower stress plateau at about 20 ksi.
After the transformation back to austenite is complete, further stress reduction results in elastic strain reduction. This ability to incur significant strain at relatively constant stress upon the application of a load and to recover from the deformation upon the removal of the load is commonly referred to as non-linear pseudoelasticity (or superelasticity).
As apparent from comparing curve B to curve A in
The material employed to manufacture the filtering element 26 can be modified thermoplastic polyurethane elastomer. Such elastomers can be prepared by reacting polyester or polyester diol, a short-chain diol, a diisocyanate, and a substituted diol. The isocyanate portion is commonly referred to as the hard segment and the diol as the soft segment. It has been found that such a material offers excellent flexibility along with resistance to broad temperature ranges or tough end-use environments. Moreover, the presence of substituted diol makes the urethane non-blocking (non-sticking) and thus desirable in many medical applications including filtering and embolic protection systems use.
The filter element can be made from thermoplastic polyurethane elastomers (TPU) made with substituted “diol.” TPUs have both the mechanical as well as physical properties that are highly desirable in medical device applications. Filter element made with substituted “diol” TPU is non-blocking (non-sticking) and thus self adherence or undesirable adherence to other structures is minimized. Such a characteristic is a key to the effectiveness of a filter or other medical device as repeated manipulation and expansion and compression is common in the use of a filter. Thus, a filter made with modified TPUs (for example, modified PELLATHANE™), can consistently provide a surface or cavity for receiving matter and can be moved and expanded or contracted in vasculature to effectively accomplish its filtering function.
A combination of high tensile strength and high elongation of modified thermoplastic polyurethane elastomers contemplated makes the material well-suited for dip forming or molding applications. Notably, conventional methods such as blow molding inherently creates stresses and tensions in the element being blow molded.
In certain applications, it may be desirable to apply a biocompatible lubricous coating to the filtering device. Such a lubricous coating can be Dow Corning 360 or other known biocompatible coatings. The coating can aid in the use of the filtering device, for example, by facilitating deployment and manipulation. The filter element itself can be coated as well as the frame or cage to which it is attached.
The materials used for the restraining sheath 30 can be made from polymeric material such as cross-linked HDPE. This sheath can alternatively be made from a material such as polyolifin which has sufficient strength to hold the compressed filter assembly and has relatively low frictional characteristics to minimize any friction between the filtering assembly and the sheath. Friction can be further reduced by applying a coat of silicone lubricant, such as M1CROGLIDE®, to the inside surface of the restraining sheath before the sheaths are placed over the filtering assembly.
It should be appreciated that the embodiments of the embolic filtering device described herein are by way of example only and not by way of limitation. Also, while the present invention is described in detail as applied to an artery of the patient, those skilled in the art appreciate that it can also be used in a variety of arteries or other body lumens, such as the coronary arteries, carotid arteries, renal arteries, saphenous vein grafts and other peripheral arteries. Additionally, the present invention can be used when a physician performs any one of a number of interventional procedures, such as balloon angioplasty, laser angioplasty or atherectomy, including those which generally require an embolic filtering device to capture embolic debris created during the procedure.
Other than in the operating example, or where otherwise indicated, all numbers expressing quantities of ingredients, reaction conditions, and so forth used in the specification and claims are to be understood as being modified in all instances by the term “about.” Accordingly, unless indicated to the contrary, the numerical parameters set forth in the following specification and attached claims are approximations that may vary depending upon the desired properties sought to be obtained by the present invention. At the very least, and not as an attempt to limit the application of the doctrine of equivalents to the scope of the claims, each numerical parameter should be construed in light of the number of significant digits and ordinary rounding approaches.
Further modifications and improvements may additionally be made to the device and method disclosed herein without departing from the scope of the present invention. Accordingly, it is not intended that the invention be limited, except as by the appended claims.