Patent Application
20050267491
The present invention relates generally to the field of medical devices. More specifically, the present invention pertains to embolectomy devices for removing foreign objects within a body lumen.
Embolectomy devices such as inflatable catheters and clot pullers are used in a variety of applications to remove blood clots or other foreign objects from a blood vessel. In applications involving the cerebrovasculature, for example, such devices may be used to remove a blood clot from an intracranial artery for the treatment of ischemic stroke. The formation of thrombus within the artery may partially block or totally occlude the flow of blood through the artery, preventing blood from reaching the brain or other vital organs. Such thrombolytic events may also be exacerbated by atherosclerosis, a vascular disease that causes the vessels to become tortuous and narrowed. The tortuosity or narrowness of the vessel may, in certain circumstances, lead to the formation of atherosclerotic plaque, which can cause further complications to the body if not treated.
In embolectomy procedures for removing blood clots, a delivery catheter or sheath is typically inserted percutaneously into the body (e.g. via the femoral, jugular or antecubital veins) and advanced to a target site within the body containing the clot. To ascertain the precise location of the clot within the body, a radiopaque die can be injected into the body to permit the occluded vessel to be radiographically visualized with the aid of a fluoroscope. A Fogarty catheter or other suitable delivery device can be used to transport the embolectomy device in a collapsed position distal the site of the blood clot. The embolectomy device is then deployed, causing the embolectomy device to expand in the vessel. The embolectomy device can then be urged in the proximal direction to remove the clot from the vessel wall, if necessary. A wire basket, coil, membrane or other collector element can be used to capture the clot as it is dislodged from the vessel wall. Once entrained within the collector element, the embolectomy device and captured blood clot are then loaded into a retrieval device and withdrawn from the patient's body.
The efficacy of the embolectomy device to dislodge the blood clot from the vessel wall depends in part on the mechanical strength of the collector element. In an embolectomy device employing basket-type filters, for example, the proximal section of the device must have sufficient strength to support the filter basket in an expanded position while the blood clot is dislodged from the vessel wall. An insufficient amount of strength at the proximal section of the device may, in certain circumstances, cause the filter basket to deflect away from the vessel wall at the site of the blood clot. As a result, the ability of the embolectomy device to dislodge and subsequently capture the clot may be compromised.
The present invention pertains to embolectomy devices for removing foreign objects within a body lumen. An embolectomy device in accordance with an exemplary embodiment of the present invention can include a support frame having a proximal hoop and at least one rail member configured to support a flexible filter basket within the blood vessel. A portion of the support frame may be attached to an elongated member that can be manipulated during an embolectomy procedure to dislodge the foreign object from the vessel wall.
The filter basket may be actuatable between a collapsed position and an expanded position. In certain embodiments, the filter basket can be biased to self-expand when deployed in the vessel, either by a mechanical force imparted to the device, or from the use of superelastic alloys treated to exhibit certain shape-memory properties. The filter basket can include a number of filter struts of reduced dimension. A proximal set of filter struts may be employed to attach a proximal section of the filter basket to the support frame. A distal set of filter struts can be employed to attach a distal section of the filter basket and the distal end of each rail member to a bushing disposed about the elongated member.
In certain embodiments, the filter basket can include a plurality of interconnected filter struts formed from a single workpiece such as a tube, foil or sheet. The filter struts can be arranged to form a number of filter cells configured circumferentially to surround the incoming foreign object. The filter cells can also be configured to displace in multiple directions, if desired. In certain embodiments, a polymeric web covering can be placed about all or a portion of the filter basket.
The filter struts forming the filter basket can vary in flexibility to impart a particular flexibility characteristic to the embolectomy device. In some embodiments, for example, a proximal section of the filter basket can include filter struts having a relatively large cross-sectional area to impart greater mechanical strength to the portion of the embolectomy device that dislodges the foreign object from the vessel wall. The distal section of the filter basket, in turn, can include one or more struts of reduced thickness for increased flexibility as the device is advanced through the body. One or more radiopaque features may be employed to visualize the positioning and deployment status of the embolectomy device within the blood vessel.
In an exemplary method of manufacture, a workpiece of uniform thickness tubing, foil or flat sheet can be laser-cut or photo-chemically etched to form the various filter struts and support hoop of the filter basket. Selective portions of the filter basket may be masked, and a suitable reduction process such as microblasting or electropolishing may be performed to reduce the wall thickness at the unmasked areas of the filter basket. In certain embodiments, the filter struts forming the distal section of the filter basket can be reduced in thickness to impart flexibility to the distal section of the embolectomy device to aid in the advancement of the device through tortuous or narrowed vessels. Selective filter struts forming the proximal section of the filter basket can be masked to maintain their original thickness, thereby imparting greater mechanical strength to the proximal section of the embolectomy device.
The following description should be read with reference to the drawings, in which like elements in different drawings are numbered in like fashion. The drawings, which are not necessarily to scale, depict selected embodiments and are not intended to limit the scope of the invention. Although examples of construction, dimensions, and materials are illustrated for the various elements, those skilled in the art will recognize that many of the examples provided have suitable alternatives that may be utilized.
The pusher wire 22 can include a distal section 24 configured to support the support frame 12 and filter basket 20 within a blood vessel, and a proximal section (not shown) configured to lie outside of the patient's body. The pusher wire 22 can be configured similar to other guiding members used in the art (e.g. guidewires), having the ability to transmit axial and rotational motion from the proximal section of the wire to the distal section. The pusher wire 22 may be tapered slightly such that the distal section 24 of the pusher wire 22 has a smaller profile than the proximal section. A radiopaque spring coil 26 disposed about the distal section 24 of the pusher wire 22 may provide additional stiffness to the pusher wire 22 while providing a visual reference point when used in conjunction with a fluoroscope. An atraumatic distal tip 28 having a bulbous shape may also be employed, if desired, to reduce trauma to the body.
The filter basket 20 can include a number of filter struts 30 that form a cage-like structure configured to capture the incoming foreign object. A proximal set of filter struts 32 can be used to attach the filter basket 20 to the rail members 16,18 of the wire frame 12. In addition, a distal set of struts 34 can be used to couple the filter basket 20 to the distal section 24 of the pusher wire 22.
The proximal hoop 14 can be secured to the distal section 24 of the pusher wire 22 via a joint 36 located adjacent to a proximal section 38 of the embolectomy device 10. In certain embodiments, joint 36 may be formed by soldering, brazing, welding, crimping, adhering, or otherwise bonding the ends 40,42 of the proximal hoop 14 to a tubular segment 44 secured to the pusher wire 22. In an alternative embodiment (not shown), the ends 40,42 of the proximal hoop 14 can be attached directly to the pusher wire 22.
A bushing 46 disposed about the pusher wire 22 at or near a distal section 47 of the embolectomy device 10 connects the distal set of struts 34 and rail members 16,18 to the pusher wire 22. Bushing 46 may have an inner lumen configured to slidably receive the pusher wire 22, allowing the support frame 12 and filter basket 20 to move back and forth along the pusher wire 22 as the embolectomy device 10 is actuated between the collapsed and expanded positions. The bushing 46 can be attached to the distal set of struts 34 and rail members 16,18 with an epoxy or other suitable bonding agent.
Turning now to
At location 54, the left and right members 48,50 both bend and orient in a direction towards the distal section 47 of the embolectomy device 10, forming the rail members 16,18. As can be seen in
The left and right members 48,50 may each be formed of wire or ribbon having a size and shape configured to provide a desired amount of stiffness to the embolectomy device 10. In certain embodiments, for example, the left and right members 48,50 can have a circular transverse cross-sectional area having a diameter in the range of about 0.003 to 0.004 inches, although other sizes and shapes may be employed, if desired. The left and right members 48,50 can be formed from a metal, polymer, or metal-polymer blend selected to exhibit certain mechanical characteristics such as torsional rigidity and stiffness. In certain embodiments, the left and right members 48,50 can be formed from a superelastic material such as a nickel-titanium alloy (Nitinol), allowing the embolectomy device 10 to be collapsed into relatively small delivery devices such as a microcatheter or the like. The superelastic material can be treated to exhibit certain shape-memory properties when deployed in the body. For example, the members 48,50 can be heat-treated to revert from a collapsed position having a relatively small profile to an expanded position such as that depicted in
Although the four struts 56,58,60,62 depicted in
The distal set of struts 34 can include four struts 66,68,70,72 which together connect the distal end of the filter basket 20 to the pusher wire 22. The four struts 66,68,70,72 can be oriented to converge in symmetrical fashion at the bushing 46, thereby closing the distal section 47 of the embolectomy device 10 to prevent the escape of the foreign object. When assembled, the filter basket 20 has a generally conical shape with its apex located adjacent to the proximal hoop 14 of the support frame 12. As with the proximal set of struts 32, the number of struts employed may vary to alter the filtering characteristics of the filter basket 20.
As can be further seen in
In certain embodiments, the thickness of the various struts used in forming the filter basket 20 can be made thinner than the thickness of the rail members 16,18 to impart greater flexibility to the filter basket 20. For example, at least one of the filter struts forming the filter basket 20 can have a diameter of about 0.002 inches whereas the members 48,50 used to form the proximal hoop 14 and rail members 16,18 can have a larger diameter of about 0.003 to 0.004 inches.
The embolectomy device 10 can include one or more radiopaque features which allow the device to be visualized within the body using a fluoroscope. For example, one or more radiopaque coils or marker bands placed on selective locations of the embolectomy device 10 may be used to identify the location of the device 10 in the body. In certain embodiments, for example, a radiopaque coil formed of platinum can be placed about the proximal hoop 14 and/or rail members 16,18 which, when viewed with a fluoroscopic monitor, allow the operator to determine the location and status (i.e. deployed or collapsed) of the embolectomy device 10.
The manufacturing of the filter basket 20 as well as other components of the embolectomy device 10 can be accomplished by a number of different methods and techniques. In certain techniques, for example, a tubular workpiece may be cut and/or etched to form the various struts of the filter basket 20. Alternatively, a foil or flat sheet of material can be cut and/or etched, and then rolled into a tubular shape and bonded along a seam or attached to a wire to form the filter basket 20. An electropolishing process or other suitable technique may be used to provide a smooth finish to the final, cut filter basket 20. In some embodiments, a hydrophilic, hydrophobic or other suitable coating can be placed on the filter basket 20 and/or other components of the embolectomy device 10 to reduce friction or other restrictive force as the device is advanced through the body or placed into contact with the delivery device.
The support frame 82 and pusher wire 92 can be configured similar to the support frame 12 and pusher wire 22 described above with respect to
The filter basket 90 can include a proximal set of struts 114 that attach the filter basket 90 to the rail members 86,88, and a distal set of struts 116 that couple the filter basket 90 to the distal section 94 of the pusher wire 92. As shown in
The distal set of struts 116 can include six struts 122 that converge and attach to the bushing 112 in symmetrical fashion, thus closing the distal section 113 of the embolectomy device 80. As with the proximal set of struts 114, the number and relative orientation of each of the distal set of struts 116 can vary to alter the containment characteristics of the filter basket 90, if desired.
In addition to the proximal and distal set of struts 114,116, filter basket 90 can include a number of other filtering struts 124 forming a cage-like structure configured to capture emboli while maintaining the perfusion of blood through the vessel. The filtering struts 124 can be oriented in a generally longitudinal direction along the length of the filter basket 90, and can have an undulating shape that grips the foreign object as it is captured. In certain embodiments, greater flexibility can be imparted to the filter basket 90 by reducing the thickness of the filter struts 124 as well as the proximal and distal sets of struts 114,116. Such flexibility allows the various filter struts to easily bend or flex when the incoming clot is received, allowing the device 80 to capture the foreign object without severing or breaking the object into smaller fragments.
The filter basket 130 can include several filter struts 140 and connecting junctures 142 that form a number of basket cells 144 configured circumferentially to surround and capture the foreign object therein. The filter basket 130 can include an opening 146 in a proximal section 148 of the embolectomy device 128, which receives the incoming foreign object as it is dislodged from the vessel wall. The basket opening 146 can be configured to grip or pinch the foreign object when the embolectomy device 128 is withdrawn slightly into the distal end of the delivery device. The basket cells 144 located on the proximal section 148 of the embolectomy device 128 can be arranged in a circumferential manner, forming an inner lumen 150 within the filter basket 130 that receives the incoming foreign object. Several basket cells 152 located at a distal section 154 of the filter basket 130 can have a closed configuration, preventing the foreign object or other emboli from escaping from the filter basket 130 once captured therein.
The basket opening 146 may have a scoop-like shape that, when engaged along the vessel wall, dislodges the clot without slipping. The size of the opening 146 can be selected to engage foreign objects at various locations within the vasculature, such as at bifurcated locations. The profile of the filter basket 130 can be generally cylindrical, conical, or other desired shape.
The filter struts 140 forming the basket cells 144 can be configured to move and expand in multiple directions. In a first direction, the filter struts 140 can be configured to act in a radial direction, providing an outward force to aid in expansion of the device 128 within the vessel. In a second direction, strut 140 compression can be reduced when an axial load is asserted along the longitudinal axis of the device 128. In a third direction, the filter struts 140 along the top portion of the device 128 located furthest away from the pusher wire 132 may be configured to move more in the longitudinal direction than the filter struts 140 located immediately adjacent to the pusher wire 132, thereby imparting a bending or folding movement to the embolectomy device 128. In use, this bending or folding movement allows the junctures 142 of the filter basket 130 to be more evenly dispersed, imparting greater flexibility, a lower profile, and reduced friction to the embolectomy device 128. As with previous embodiments, the filter struts 140 can be electro-polished and/or can include a hydrophilic or hydrophobic coating, further improving the deliverability of the device 128.
In certain embodiments, the filter struts 140 can include a superelastic material such as a nickel-titanium alloy (Nitinol) having certain shape-memory properties that permit the embolectomy device 128 to revert to a particular shape when exposed to a certain temperature within the body. In certain embodiments, for example, the filter struts 140 may be made from a superelastic material having an As-Af transition temperature set above body temperature (e.g. at 40-50° C.). The material can be heat-set such that the filter basket 130 remains collapsed at temperatures below the final austenitic temperature Af of the material, thus imparting less radial force on the inner wall of the delivery device during delivery. The embolectomy device 128 can be loaded into the distal end of the delivery device in its unexpanded form, and delivered to a target site within a vessel. An infusion of warm saline or other suitable fluid can then be injected into the lumen of the delivery device, transforming the filter basket 130 from a collapsed position to an expanded position within the vessel.
The filter basket 130 may further include a polymeric web covering to further capture the foreign object or any other emboli therein. As shown in
Referring now to
After being positioned at the target site, the embolectomy device 10 can then be deployed from within the delivery device 10, causing the device 10 to expand within the blood vessel V, as shown in
Once deployed in the blood vessel V, the embolectomy device 10 can then be pulled proximally a distance to dislodge the blood clot C from the vessel V, as shown in
In the exemplary embodiment of
The proximal hoop 182 may include a wire 184 coupled to the distal section 172 of elongated member 168. In the embodiment illustrated in
Examples of suitable materials used to form the proximal hoop 182 include metals such as nickel-titanium alloy (Nitinol), Beta III Titanium and stainless steel, or polymeric materials such as polyvinyl chloride (PVC). The proximal hoop 182 can also be formed from metal/metal or metal/polymer composites, and can include an anti-thrombogenic layer or coating such as heparin (or its derivatives), urokinase or PPack (dextrophenylalanine proline arginine chloromethylketone) to reduce insertion site thrombosis from occurring. Moreover, the embolectomy device 164 can include a hydrophobic or hydrophilic coating to reduce friction of the device through the vasculature. One or more articulation regions 188 on the proximal hoop 182 may be employed to facilitate the collapse of the filter basket 166 as it is loaded into the delivery device.
The thickness of the filter struts 176 may vary from the proximal section 178 of filter basket 166 towards the distal section 180 of filter basket 166 to alter the stiffness along the length of the embolectomy device 164. For example, as shown in
The thickness of the filter struts 176 can be reduced gradually from the proximal section 178 towards the distal section 180 of the filter basket 166, producing a gradual transition in stiffness and rigidity along the length of the embolectomy device 164. For example, the thickness of each filter strut 176 can be reduced along the length of the filter basket 166 such that the proximal end of the filter basket 166 has the greatest stiffness, whereas the distal end of the filter basket 166 has the greatest flexibility. The thickness of the filter struts 176 can also be selectively reduced such that only some of the struts in a particular section (e.g. the distal section 180) are reduced in dimension.
Although the structural properties of the embolectomy device 164 may be controlled via the use of filter struts of varying thickness, it should be understood that other factors could be altered to affect the characteristics of the device. For instance, the number of filter struts forming each section may be selected to impart a particular stiffness characteristic to the filter basket. The geometry and material composition of the filter struts, and the number of junctures interconnecting each strut, may also be selected to alter the mechanical properties of the device. For example, although the particular filter struts 176 illustrated in
Embolectomy device 164 can further include one or more features to enhance the radiopacity of the device within the body. For example, as shown in
Although the use of radiopaque markers is specifically illustrated in
Formation of the filter basket 166 may be accomplished by a laser machining process or other suitable manufacturing method. In one exemplary method of manufacture, a workpiece of metallic tubing having a uniform wall thickness can be cut with the aid of a laser to form the various filter struts and junctures forming the filter basket. In an alternative method, a foil or flat sheet of uniform thickness material can be cut with a laser to form the filter struts and junctures, and then rolled into a tubular shape and joined to form the filter basket. The metallic tubing, foil, or flat sheet can be reduced in width from one end to the opposite end such that, when formed, the filter basket has a tapered shape from the proximal end towards the distal end.
Once cut, selective portions of the filter basket are then masked, and a process such as microblasting, chemical etching, or electropolishing can be used to reduce the wall thickness of the unmasked filter struts. In a microblasting process, for example, selective filter struts may be temporarily masked to preserve their shape, and a dry abrasive powder can be ejected through a nozzle and impinged upon the unmasked struts to reduce their thickness. The amount of thickness reduction can be controlled by varying the volume, pressure and duration the abrasive powder is placed into contact with the unmasked filter struts. Once the filter struts have been reduced to the desired dimension, the temporary masks can be removed. The filter basket can then be attached to the elongated member by using solder, crimping, brazing, adhesive, or other suitable bonding technique. In use, the reduction in dimension at the unmasked areas imparts flexibility to the filter basket, allowing the basket to bend or flex more easily as the embolectomy device is advanced through the vasculature.
Referring now to
In a second position illustrated in
Although the exemplary method illustrated in
Having thus described the several embodiments of the present invention, those of skill in the art will readily appreciate that other embodiments may be made and used which fall within the scope of the claims attached hereto. Numerous advantages of the invention covered by this document have been set forth in the foregoing description. Changes may be made in details, particular in matters of size, shape, and arrangement of parts without exceeding the scope of the invention. It will be understood that this disclosure is, in many respects, only illustrative.
This application is a continuation application of U.S. application Ser. No. 10/698,760, filed on Oct. 30, 2003, which in turn claims benefit to provisional U.S. Patent Application Nos. 60/460,586 and 60/460,630, both filed on Apr. 2, 2003.
| Number | Date | Country | |
|---|---|---|---|
| 60460586 | Apr 2003 | US | |
| 60460630 | Apr 2003 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10698760 | Oct 2003 | US |
| Child | 11184497 | Jul 2005 | US |
