Patent Application
20060009785
1. Field of Endeavor
The present invention relates to medical devices and more particularly to a shape memory polymer medical device.
2. State of Technology
U.S. Pat. No. 5,836,868 for an expandable intravascular occlusion material removal devices and methods of use, by Ressemann, et al., patented Nov. 17, 1998, provides the following description: “The present invention generally relates to constructions for intravascular treatment devices useful for removing vascular occlusion material from a vascular occlusion or from a vascular lumen. The invention more specifically relates to expandable intravascular occlusion material removal devices, as well as to methods of using those devices to treat vascular diseases.
Vascular diseases, such as atherosclerosis and the like, have become quite prevalent in the modern day. These diseases may present themselves in a number of forms. Each form of vascular disease may require a different method of treatment to reduce or cure the harmful effects of the disease. Vascular diseases, for example, may take the form of deposits or growths in a patient's vasculature which may restrict, in the case of a partial occlusion, or stop, in the case of a total occlusion, blood flow to a certain portion of the patient's body. This can be particularly serious if, for example, such an occlusion occurs in a portion of the vasculature that supplies vital organs with blood or other necessary fluids.
To treat these diseases, a number of different therapies are being developed. While a number of invasive therapies are available, it is desirable to develop non-invasive therapies as well. Non-invasive therapies may be less risky than invasive ones, and may be more welcomed by the patient because of the possibility of decreased chances of infection, reduced post-operative pain, and less post-operative rehabilitation. One type of non-invasive therapy for vascular diseases is pharmaceutical in nature. Clot-busting drugs have been employed to help break up blood clots which may be blocking a particular vascular lumen. Other drug therapies are also available. Further non-invasive, intravascular treatments exist that are not only pharmaceutical, but also revascularize blood vessels or lumens by mechanical means. Two examples of such intravascular therapies are balloon angioplasty and atherectomy which physically revascularize a portion of a patient's vasculature.
Balloon angioplasty comprises a procedure wherein a balloon catheter is inserted intravascularly into a patient through a relatively small puncture, which may be located proximate the groin, and intravascularly navigated by a treating physician to the occluded vascular site. The balloon catheter includes a balloon or dilating member which is placed adjacent the vascular occlusion and then is inflated. Intravascular inflation of the dilating member by sufficient pressures, on the order of 5 to 12 atmospheres or so, causes the balloon to displace the occluding matter to revascularize the occluded lumen and thereby restore substantially normal blood flow through the revascularized portion of the vasculature. It is to be noted, however, that this procedure does not remove the occluding matter from the patient's vasculature, but displaces it.
While balloon angioplasty is quite successful in substantially revascularizing many vascular lumens by reforming the occluding material, other occlusions may be difficult to treat with angioplasty. Specifically, some intravascular occlusions may be composed of an irregular, loose or heavily calcified material which may extend relatively far along a vessel or may extend adjacent a side branching vessel, and thus are not prone or susceptible to angioplastic treatment. Even if angioplasty is successful, thereby revascularizing the vessel and substantially restoring normal blood flow therethrough, there is a chance that the occlusion may recur. Recurrence of an occlusion may require repeated or alternative treatments given at the same intravascular site.
Accordingly, attempts have been made to develop other alternative mechanical methods of non-invasive, intravascular treatment in an effort to provide another way of revascularizing an occluded vessel and of restoring blood flow through the relevant vasculature. These alternative treatments may have particular utility with certain vascular occlusions, or may provide added benefits to a patient when combined with balloon angioplasty and/or drug therapies.
One such alternative mechanical treatment method involves removal, not displacement, as is the case with balloon angioplasty, of the material occluding a vascular lumen. Such treatment devices, sometimes referred to as atherectomy devices, use a variety of means, such as lasers, and rotating cutters or ablaters, for example, to remove the occluding material. The rotating cutters may be particularly useful in removing certain vascular occlusions. Since vascular occlusions may have different compositions and morphology or shape, a given removal or cutting element may not be suitable for removal of a certain occlusion. Alternatively, if a patient has multiple occlusions in his vasculature, a given removal element may be suitable for removing only one of the occlusions. Suitability of a particular cutting element may be determined by, for example, its size or shape. Thus, a treating physician may have to use a plurality of different treatment devices to provide the patient with complete treatment. This type of procedure can be quite expensive because multiple pieces of equipment may need to be used (such intravascular devices are not reusable because they are inserted directly into the blood stream), and may be tedious to perform because multiple pieces of equipment must be navigated through an often-tortuous vascular path to the treatment site.”
U.S. Pat. No. 5,102,415, for an apparatus for removing blood clots from arteries and veins, by Guenther, et al., patented Apr. 7, 1992, provides the following description: “A triple catheter for removing of blood clots from arteries and veins is equipped with an outer catheter that can be inserted into a blood vessel and an inner catheter with an inflatable balloon at its distal end that can be inserted into the outer catheter. The inner catheter is surrounded by an intermediate catheter also inserted into the outer catheter. The intermediate catheter has a radially expandable distal end receptacle made of an elastic mesh structure of spring wires or plastic monofilaments covered by or embedded in an elastic plastic coating. A very small puncture channel is required for the insertion of such a triple catheter through the wall of a blood vessel.”
U.S. Pat. No. 5,645,564 for microfabricated therapeutic actuator mechanisms, by Northrup, et al., patented Jul. 8, 1997, provides the following description: “Electromechanical microstructures (microgrippers), either integrated circuit (IC) silicon-based or precision machined, to extend and improve the application of catheter-based interventional therapies for the repair of aneurysms in the brain or other interventional clinical therapies. These micromechanisms can be specifically applied to release platinum coils or other materials into bulging portions of the blood vessels also known as aneurysms. The “micro” size of the release mechanism is necessary since the brain vessels are the smallest in the body. Through a catheter more than one meter long, the micromechanism located at one end of the catheter can be manipulated from the other end thereof. The microgripper (micromechanism) of the invention will also find applications in non-medical areas where a remotely actuated microgripper or similar actuator would be useful or where micro-assembling is needed.”
U.S. Pat. No. 6,102,917 for a shape memory polymer (SMP) gripper with a release sensing system, by Maitland, et al., patented Aug. 15, 2000, provides the following description: “A system for releasing a target material, such as an embolic coil from an SMP located at the end of a catheter utilizing an optical arrangement for releasing the material. The system includes a laser, laser driver, display panel, photodetector, fiber optics coupler, fiber optics and connectors, a catheter, and an SMP-based gripper, and includes a release sensing and feedback arrangement. The SMP-based gripper is heated via laser light through an optic fiber causing the gripper to release a target material (e.g., embolic coil for therapeutic treatment of aneurysms). Various embodiments are provided for coupling the laser light into the SMP, which includes specific positioning of the coils, removal of the fiber cladding adjacent the coil, a metal coating on the SMP, doping the SMP with a gradient absorbing dye, tapering the fiber optic end, coating the SMP with low refractive index material, and locating an insert between the fiber optic and the coil.”
U.S. Pat. No. 5,843,118 for fibered micro vaso-occlusive devices, by Sepetka, et al., patented Dec. 1, 1998, provides the following description: “This is a vaso-occlusive device made up of at least one short retainer and a longer fiber bundle. The retainer may be radio-opaque. The fibers may be straight, looped, or tufted. The primary use of the device is in the very small vessels at the distal portion of the vasculature.”
U.S. Pat. No. 5,895,398 for a method of using a clot capture coil, by Wensel, et al., patented Apr. 20, 1999, provides the following description: “A clot and foreign body removal device is described which comprises a catheter with at least one lumen. Located within the catheter is a clot capture coil that is connected to an insertion mandrel. In one embodiment, the clot capture coil is made out of a solid elastic or superelastic material which has shape memory, preferably nitinol. The elasticity or superelasticity of the coil allows it to be deformed within the catheter and to then reform its original coil configuration when the coil is moved outside of the catheter lumen. In another embodiment the coil is a biphasic coil which changes shape upon heating or passing an electric current. Once the coil configuration has been established, the coil can be used to ensnare and corkscrew a clot in a vessel. A clot is extracted from the vessel by moving the clot capture coil and catheter proximally until the clot can be removed or released into a different vessel that does not perfuse a critical organ. Foreign bodies are similarly captured by deploying the coil distal to the foreign body and moving the clot capture coil proximally until the foreign body is trapped within the coil. By removing the device from the body, the foreign material is also removed.”
Patents and patent applications that provide additional background information include: U.S. Pat. No. 3,868,956 to Alfidi, Ralph J. and Cross, William B., “Vessel Implantable Appliance and Method of Implanting It,” Mar. 4, 1975; U.S. Pat. No. 3,996,938 to Clark, W. T., “Expanding Mesh Catheter,” Dec. 14, 1976; U.S. Pat. No. 4,140,126 to Choudhury, M. H., “Method for Performing Aneurysm Repair,” Feb. 20, 1979; U.S. Pat. No. 4,706,671 to Weinrib, H. P., “Catheter with Coiled Tip,” Nov. 17, 1987; U.S. Pat. No. 4,873,978 to Ginsburg, R., “Device and Method for Emboli Retrieval,” Oct. 17, 1989; U.S. Pat. No. 5,011,488 to Ginsburg, R., “Thrombus Extraction System,” Apr. 30, 1991; U.S. Pat. No. 5,049,591 to Hayashi, S. and Fujimori, H. “Shape Memory Polymer Foam,” Sep. 17, 1991; U.S. Pat. No. 5,102,415 to Guenther, R. W. and Vorwerk, D., “Apparatus for Removing Blood Clots from Aarteries and Veins,” Apr. 7, 1992; U.S. Pat. No. 5,330,483 to Heaven, M. D., and Schuler, M., “Specimen Reduction Device,” Jul. 9, 1994; U.S. Pat. No. 5,370,609 to Drasler, W. J., Dutcher, R. G., Jenson, M. L., Thielen, J. M., Protonotarios, E. I., “Thrombectomy Device,” Dec. 6, 1994; U.S. Pat. No. 5,411,509 to Hilal, S., “Embolectomy Catheter,” May 2, 1995; U.S. Pat. No. 5,490,859 to Mische, H. A., Ressemann, T. V., Vrba, A. C., and Hackett, S. S., “Expandable Intravascular Occlusion Materials Removal Devices and Methods of Use,” Feb. 13, 1996; U.S. Pat. No. 5,603,722 to Phan, L., Froix, M. and Stertzer, S., “Intravascular Stent,” Feb. 18, 1997; U.S. Pat. No. 5,674,242 to Phan, L., et al., “Endoprosthetic Device With Therapeutic Compound,” Oct. 7, 1997; U.S. Pat. No. 5,762,630 to Bley, R., and Kubacki, G., “Thermally Softening Stylet,” Jun. 9, 1998; U.S. Pat. No. 5,792,157 to Mische, H. A., Ressemann, T. V., Hoium, S. A., “Expandable Intravascular Occlusion Material Removal Devices and Methods of Use,” Aug. 11, 1998; U.S. Pat. No. 5,846,247 to Unsworth, J. D., and Waram, T. C., “Shape Memory Tubular Deployment System,” Dec. 8, 1998; U.S. Pat. No. 5,897,567 to Ressemann, T. V., Vrba, A. C., Hackett, S. S., Kugler, C. J., Mische, H. A., “Expandable Intravascular Occlusion Material Removal Devices and Methods of Use,” Apr. 27, 1999; U.S. Pat. No. 5,902,518 to Khazai, B. and Nichols, G. M., “Self-regulating Polymer Composite Heater,” May 11, 1999; U.S. Pat. No. 5,910,357 to Hachisuka, H., Kondo, Y., Ikeda, K., Takano, H., Mochisuki, H., “Separation Membrane and Method of Producing the Same, and Shape Memory Composition,” Jun. 8, 1999; U.S. Pat. No. 5,957,966 to Schroeppel, E. A., Spehr, P. R., and Machek, J. E., “Implantable Cardiac Lead with Multiple Shape Memory Polymer Structures,” Sep. 28, 1999; U.S. Pat. No. 5,964,744 to Balbierz, D. J. Walker, J. M., Thomas, J. R., Bley, R. S., Van Bladel, K., “Polymeric Medical Devices Having Shape Memory,” Oct. 12, 1999; U.S. Pat. No. 6,022,309 to Celliers, P., Da Silva, L., Glinsky, M., London, R., Maitland, D., Matthews, D., Fitch, P., “Optoacoustic Thrombolysis,” Feb. 8, 2000; U.S. Pat. No. 6,086,599 to Lee, A. P., Fitch, “Micro Devices Using Shape Memory Polymer Patches for Mated Connections,” Jul. 11, 2000; U.S. Pat. No. 6,090,072 to Kratoska, W. F., Tay, S.-W., Thome, S. P., Keith, P. T., “Expandable Introducer Shealth,” Jul. 18, 2000; U.S. Pat. No. 6,102,933 to Lee, A. P., Northrup, A., Ciarlo, D. R., Krulevitch, P. A., and Bennett, W. J., “Release Mechanism Utilizing Shape Memory Polymer material,” Aug. 15, 2000; U.S. Pat. No. 6,120,515 to Rogers, L., Buckley, J. T., Hundermark, R. R., Powell, F. T., Milo, C., and Castro, A. J., “Composite Atherectomy Cutter,” Sep. 19, 2000; EP0337918B1 to Monfort, M. Y, Molenauer, K. M., and Chin, A. K., “Endarectomy Apparatus,” Nov. 9, 1994; EP0472368B1: Fearnot, N. E., “Ablation Catheter,” Jun. 28, 1995; W00003643: Maitland, D. J., Lee, A. P., Schumann, D. L., and Da Silva, L., “Shape Memory Polymer Gripper with a Release Sensing System,” Jan. 27, 2000; U.S. Pat. No. 6,740,094 issued May 25, 2004 to Duncan J. Maitland, Abraham P. Lee, Daniel L. Schumann, Dennis Matthews, Derek Decker for a Shape Memory Polymer Actuator and Catheter; and U.S. Patent Application No. U.S. 2003/0236533 by Thomas S. Wilson, Duncan Maitland, Daniel L. Schumann, Steve L. Little, and Paul E. Ahre published Dec. 25, 2003 for a Shape Memory Polymer Actuator and Catheter.
Features and advantages of the present invention will become apparent from the following description. Applicants are providing this description, which includes drawings and examples of specific embodiments, to give a broad representation of the invention. Various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this description and by practice of the invention. The scope of the invention is not intended to be limited to the particular forms disclosed and the invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the claims.
The present invention provides a system for removing matter from a conduit. The system includes the steps of passing a transport vehicle and a shape memory polymer material through the conduit, transmitting energy to the shape memory polymer material for moving the shape memory polymer material from a first shape to a second and different shape, and withdrawing the transport vehicle and the shape memory polymer material through the conduit carrying the matter. Access to the conduit may be gained using additional means, such as a catheter. The system utilizes a shape memory polymer device for acting upon a material in a conduit. A transport vehicle is adapted to move through the conduit. A shape memory material is operatively connected to the transport vehicle. The transport vehicle with the shape memory polymer material attached may be delivered into the conduit using a catheter or similar means. The shape memory material is adapted to move from a first shape to move through or around the material, to a second and different shape for acting upon the material. A heat transfer mechanism is operatively connected to the shape memory material and is adapted to transfer heat to the shape memory material to move the shape memory material from the first shape to the second shape. The transport vehicle and the shape memory polymer material are withdrawn through the conduit carrying the matter.
Uses of the present invention include, but are not limited to, the removal of obstructions from vascular or non-vascular passageways in the body. Such occlusions may include a thrombus (clot), plaque, fatty deposits, and other natural materials as well as fragments of man made devices. An example of an application is blood clot removal following ischemic stroke.
The invention is susceptible to modifications and alternative forms. Specific embodiments are shown by way of example. It is to be understood that the invention is not limited to the particular forms disclosed. The invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the claims.
The accompanying drawings, which are incorporated into and constitute a part of the specification, illustrate specific embodiments of the invention and, together with the general description of the invention given above, and the detailed description of the specific embodiments, serve to explain the principles of the invention.
Referring to the drawings, to the following detailed description, and to incorporated materials, detailed information about the invention is provided including the description of specific embodiments. The detailed description serves to explain the principles of the invention. The invention is susceptible to modifications and alternative forms. The invention is not limited to the particular forms disclosed. The invention covers all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the claims.
Thromboembolic disorders, such as stroke, pulmonary embolism, thrombosis, and arteriosclerosis are a major cause of morbidity and mortality in the United States. Such disorders are characterized by the partial or complete occlusion of a blood vessel by clots, fatty deposits, or plaque. The tissue downstream of the occluded artery becomes ischemic (oxygen and nutrient deprived). If the occlusion persists, the condition will gradually worsen with time until the cell death (infarction) occurs. The end result, if circulation is not restored, can be loss of limb, angina pectoris, myocardial infarction, stroke, or death.
There are several existing techniques to re-establish flow in occluded vascular passageways and these include balloon angioplasty, balloon embolectomy, and catheter based percutaneous methods such as treatment with thrombolytic drugs, various types of atherectomy, and removal of thromboembolic material with capture coils and like devices.
In balloon angioplasty, a balloon tipped catheter is non-surgically introduced into the vasculature and advanced to the point of occlusion. The balloon section of the catheter is advanced into the stenotic region and next inflated to dilate the blockage. Balloon angioplasty then does not remove the material causing the occlusion, which are subject to future complications such as restenosis or embolic events and is especially unsuitable for smaller vessels.
A common technique for treatment of clots is to place a microcatheter near the clot and infuse a thrombolytic material such as streptokinase, urokinase, or recombinant tissue plasminogen activator (rTPA) to dissolve the clot. However, thrombolysis typically takes hours to days to remove the clot and is typically ineffective unless administered within approximately 3 hours of the thromboembolic event. Thrombolytics also can cause severe hemorrhaging in patients, especially if used after the initial three hour use window, and cannot be used at all in some patients.
One of the first percutaneous methods for recanalization through vascular occlusions involved balloon embolectomy. A catheter with a balloon tip on the distal end is advanced to the site of occlusion through a guide catheter. The distal end is advanced past the site of the occlusion and the balloon is inflated to fill the vascular passageway. It is then pulled back toward the guide catheter, dislodging embolic material from the vascular lumen while doing so. The occluding material is then withdrawn into the guide catheter by the pushing action of the balloon. While devices for balloon embolectomy have improved over the years, there remain problems such as being able to effectively separate material from the vascular lumen and removing the occlusion without it breaking into fragments which can move downstream and lodge in a smaller vessel, causing another thromboembolic event. There are also size limitations on using balloons for expansion of the distal end, preventing this type of device from being usable in small vessels.
Various percutaneous techniques for atherectomy have been developed based on mechanical, hydrodynamic, and acoustic methods for breaking up the occlusion and removal of the resulting debris. For example, several devices have been developed using a high speed rotary abrasion tool comprising abrasive embedded wires or wire meshes which can be controllably expanded by balloon action or longitudinal compression of the wire mesh resulting in circumferential expansion. These devices mechanically grind the occluding material into small fragments which can be withdrawn back up through the catheter via suction. However, such devices are limited to larger size vessels due to limits in construction, being able to move the devices to a smaller tortuous lumen, and in being able to transmit torque once the device falls below a certain size.
Another atherectomy device is described in U.S. Pat. No. 5,370,609 which uses a high velocity jet of saline to create high local shear stresses at the catheter tip, in turn breaking the clot into small pieces. This device has advantages of not having any moving parts, of high speed, flexible for moderate vessels, and good removal of clot debris. However, current designs are unable to be used in vessels smaller than 3 mm, while most embolic strokes occur in vessels smaller than this.
Acoustic wave based thrombectomy devices have also been developed for recanalization of blocked vessels. Acoustic wave generating devices are used at the distal end of the catheter to break the occlusive material into very small pieces, which can then be either suctioned out or in some cases left for re-absoption by the body. Such devices are still experimental and not yet being used commercially.
Embolic coil and other clot capture devices have been developed for thrombectomy as shown by U.S. Pat. No. 4,706,671; U.S. Pat. No. 4,873,978 and U.S. Pat. No. 5,895,398. These devices operate in a manner similar to the balloon embolectomy, but using means for retrieving the clot.
Shape-memory materials have the useful ability of being formable into a primary shape, being reformable into a stable secondary shape, and then being controllably actuated to recover their primary shape. Both metal alloys and polymeric materials can have shape memory. In the case of metals, the shape-memory effect arises from thermally induced solid phase transformations in which the lattice structure of the atoms changes, resulting in macroscopic changes in modulus and dimensions. In the case of polymeric materials, the primary shape is obtained after processing and fixed by physical structures or chemical crosslinking. The secondary shape is obtained by deforming the material while in an elastomeric state and that shape is fixed in one of several ways including cooling the polymer below a crystalline, liquid crystalline, or glass transition temperature; by inducing additional covalent or ionic crosslinking, etc. While in the secondary shape some or all of the polymer chains are perturbed from their equilibrium random walk conformation, having a certain degree of bulk orientation. The oriented chains have a certain potential energy, due to their decreased entropy, which provides the driving force for the shape recovery. However, they do not spontaneously recover due to either kinetic effects (if below their lower glass transition temperature) or physical restraints (physical or chemical crosslinks). Actuation then occurs for the recovery to the primary shape by removing that restraint, e.g., heating the polymer above its glass transition or melting temperature, removing ionic or covalent crosslinks, etc.
The present invention provides a mechanical device to remove non-vascular or vascular occlusions (e.g., blood clot) from the body. The device dimensions depend on the size and location of the occlusion targeted for removal (e.g., a device used to remove a carotid artery occlusion may be larger than a device used to remove an occlusion located further up in the neurovasculature). The preferred embodiment of the device includes: (1) an expandable coil and (2) an expandable basket. Both of these components are constructed of shape memory polymer (SMP), a polymer that can be formed into a primary or equilibrium shape, re-formed into a stable secondary or stressed shape, and actuated by controlled heating to recover its primary shape.
Referring now to the drawings and in particular to
The structural components of the shape memory polymer coil 100 having been described and illustrated in
Various incarnations of the shape memory polymer coil 100 are possible depending on the actuation mechanism. Actuation mechanisms include laser heating, resistive heating, inductive heating, heated fluid injection and heating by ambient (physiological) temperature. Additionally, the shape memory polymer coil 100 may actuate at physiological temperature through a depression in the SMP glass transition temperature caused by exposure to physiological fluids or those injected through the catheter. Though the design and construction of the shape memory polymer coil 100 are specific to the actuation mechanism, the various incarnations of the devices are functionally identical.
Referring now to the drawings and in particular to
The structural components of the shape memory polymer basket 200 having been described and illustrated in
Various incarnations of the shape memory polymer basket 200 are possible depending on the actuation mechanism. Actuation mechanisms include laser heating, resistive heating, inductive heating, heated saline flush and heating by ambient (physiological) temperature. Additionally, the shape memory polymer basket 200 may actuate at physiological temperature through a depression in the SMP Tg caused by exposure to physiological fluids or those injected through the catheter. Though the design and construction of the shape memory polymer basket 200 are specific to the actuation mechanism, the various incarnations of the devices are functionally identical.
Referring now to the drawings and in particular to
Referring now to
Referring now to
Referring now to
Various designs of the system using either the SMP coil 100 or the SMP basket 200 or the SMP coil 100 and the SMP basket 200 are possible. For example, a coil design using inductive heating actuation will be described. Ferromagnetic particles are embedded in thermosetting SMP material by mixing the particles into the SMP material prior to curing or embedded in thermoplastic SMP material through melt compounding followed by extrusion of strand. The uncured thermosetting SMP is then injection-molded directly into the “corkscrew” shape (using a 3-dimensional mold) or straight rod shape, in which case it is subsequently wrapped around a conical mandrel and heated to set the primary “corkscrew” shape. The SMP coil is mounted on the distal end of a guide wire (transport vehicle) long enough to extend through the catheter up to the occlusion. Actuation into the expanded coil form is achieved by subjecting the device to an externally generated alternating magnetic field, resulting in inductive heating of the magnetic particles. The type, size, and concentration of magnetic particles and the strength of the external magnetic field govern the heating response. No physical connection between the device and energy source is required.
A coil design using actuation through SMP adsorption of plasticizing material will be described. In this embodiment the SMP coil is mounted on a guide wire which may be a standard guide wire. In this embodiment the SMP material, which may be thermoplastic or thermoset, has a glass transition temperature that is initially higher than physiological temperature, but is depressed below physiological temperature by the adsorption of a plasticizing material, which may either be injected into the vicinity of the SMP coil through the catheter or derived from the surrounding physiological fluid. Examples of potentially plasticizing compounds are water, ethanol, and dimethyl sulfoxide. The time period between the insertion of the device into the physiology and the device actuation can be controlled; this being done for example by the time at which it is exposed to externally injected plasticizer, the use of a coating on the surface of the coil which controls the diffusion rate of plasticizer into the coil geometry and initial barrier which provides for a lag time, or the coating of the device with a material which can be controllably removed by dissolution in turn allowing for the adsorption of the plasticizer.
A coil design using actuation of SMP by equilibration to physiological temperature will be described. In this embodiment the SMP coil is mounted on a guide wire which may be a standard guide wire. In this embodiment the SMP material, which may be thermoplastic or thermoset, has a glass transition temperature that is close to physiological temperature. The SMP glass transition temperature is chosen such that the SMP coil can be delivered to through the site of the occlusion prior to the SMP reaching physiological temperature and having time kinetically to recovery its primary shape. Once placed, the SMP coil will spontaneously actuate into the coil form over time and can then be used to remove the occlusion. The kinetic hindering of the SMP coil actuation is achieved by one or more of the following methods: kinetic slowing of the heating of the SMP coil device while it remains in the catheter, coating of the SMP coil device with an elastomer (e.g., PDMS) which acts as an insulating barrier, and/or use of an SMP which has a glass transition temperature slightly above physiological temperature but which is still low enough for actuation to occur at physiological temperature. It should be noted that this mechanism is easily combined with adsorption of plasticizing material described previously to further enhance control over actuation kinetics.
A basket design using inductive heating actuation will be described. Ferromagnetic particles are embedded in the thermosetting SMP material by mixing the particles into the uncured liquid SMP material prior to injection molding. The basket is mounted to the distal end of the catheter using epoxy or by other suitable means. Actuation into the “open basket” form is achieved by subjecting the device to an externally generated alternating magnetic field, resulting in inductive heating of the magnetic particles. The type, size, and concentration of magnetic particles and the strength of the external magnetic field govern the heating response. No physical connection between the device and energy source is required.
A basket design using resistive heating actuation (Hot Catheter Tip) will be described. An electrical heating element is placed at the distal end of the catheter to which the SMP basket is mounted. The element may serve as an extension of the catheter with the SMP basket attached directly to the element. Leads running from a power supply (external to the body) extend along the catheter (through lumens in the catheter wall) and are connected to the terminals of the resistive element. Actuation into the expanded coil form is achieved by applying a voltage to drive a current through the resistive element, causing it to heat the SMP above its transition temperature.
A basket design using actuation through glass transition temperature depression with exposure of the SMP basket to plasticizing fluid will be described. The SMP basket may be caused to expand by various mechanisms. For example, the SMP basket may be exposed to and allowed to absorb a plasticizing material which depresses the SMP glass transition and allows actuation, the SMP basket may be made of an SMP with a glass transition close to physiological temperature so that actuation will occur over time once the device has reached that temperature from its initial lower temperature, or the two preceding two methods may be used together to control the kinetics of the SMP basket opening. It should be noted that in this embodiment actuation can be achieved at a controlled time without application of energy to the device.
A basket design using resistive heating with direct resistive heating of the basket will be described. The SMP basket has a conductive element embedded within the SMP. The element may be a resistive wire or conductive polymer composite. Leads running from a power supply (external to the body) extend along the catheter (through lumens in the catheter wall) and are connected to the terminals of the resistive element. Actuation into the expanded basket form is achieved by applying a voltage to drive a current through the resistive element, causing it to heat the SMP above its transition temperature.
Referring now to
The structural components of a SMP-fiber socket joint 400 of one embodiment of an actuator for acting upon a material in a vessel of the present invention having been described and illustrated in
In addition to soaking in a solution of solvent and dye or doping the uncured SMP with dye, dye may be incorporated into the devices by dipcoating in a solution consisting of dye and SMP dissolved in a solvent and then vacuum dried to remove the solvent. This process yields a device in which the dye is localized in an outer layer. In the case of the SMP coil device, this process results in more uniform axial heating of the device due to increased laser light penetration depth. A dye concentration gradient may be imparted by varying the dipcoating speed to further enhance the uniformity of heating.
In one end of the rod 404, a socket 403 is created (by mechanical or laser drilling or other means) along the longitudinal axis of the rod 404. The hole is partially filled with an optically transparent epoxy 405 whose index of refraction is chosen to maximize transmission of laser light into the SMP. The cleaved end of a glass or plastic optical fiber 402 is inserted into the hole 403 and bonded in place, being careful that any space between the cleaved end of the optical fiber 402 and the SMP surface is filled with the index-matched epoxy 405. The other end of the optical fiber 402 is coupled to a laser. The optical fiber 402 must be long enough to extend from the laser (outside the body), through a catheter to the occlusion (inside the body).
Referring again to
The SMP rod 404, with the optical fiber 402 attached, is wrapped around a conical mandrel and heated above its highest glass transition temperature to set the primary “corkscrew” shape as illustrated in
Referring now to
The structural components of a mandrel system 500 of one embodiment of an actuator for acting upon a material in a vessel of the present invention having been described and illustrated in
Uncured thermosetting SMP material can be cast into the primary “corkscrew” shape by injection-molding using a 3-dimensional mold, consisting, for example, of flexible PTFE tubing held in the desired shape, or a complex metal mold. These methods automatically set the primary shape. If injection-molded into a straight rod shape, the SMP can be re-set into the primary shape (using the same methods as the thermoplastic SMP). Laser-absorbing dye may be incorporated into the SMP by doping the uncured material prior to molding, by soaking the cured material in a solvent in which the dye is dissolved followed by vacuum drying, or by dip-coating in a solution consisting of dye and SMP dissolved in a solvent and then vacuum dried to remove the solvent, as described above. The socket to receive the optical fiber may be created by drilling, as described above, or may be incorporated into the mold. Alternatively, the optical fiber may be inserted into the SMP as it cures in the mold. In this case, the application of index-matched epoxy in the socket is not necessary. However, epoxy may be used to reinforce the bond externally. The SMP coil is manually straightened while heated slightly above its soft phase glass transition temperature to set its secondary “rod” form prior to use.
The smooth “corkscrew” shape and circular cross-section of the SMP permit the laser light to propagate along the SMP coil while providing a means of capturing an occlusion. In order for the SMP rod to behave as a light guide, the conditions for total internal reflection must be satisfied. These conditions force the index of refraction of the SMP to exceed that of its surrounding medium (e.g., blood or other body fluid) and put a lower limit on the coil turn radius established by the mandrel. Departure from these conditions will result in excessive leakage of the laser light from the SMP rod and incomplete expansion of the SMP coil. The SMP coil may be thinly coated with a material with a sufficiently low index of refraction (e.g., PDMS) to ensure light transmission regardless of the surrounding medium. However, the mechanical properties of the coating must not impede expansion of the SMP coil during laser heating. Though some of the laser light is reflected back from the distal end of the SMP coil due to the index mismatch, this effect may be augmented by making the distal end of the SMP coil reflective (e.g., coated with silver or gold) to enhance the laser heating by recapturing laser light that would otherwise escape.
Referring now to
The structural components of a wire-wrapped optical fiber 601 with attached SMP expandable coil 604 of one embodiment of an actuator for acting upon a material in a vessel of the present invention having been described and illustrated in
Referring now to
The SMP expandable coil 701 is typically delivered to the desired location via a catheter. Wire windings will encompass the optical fiber, extending from the proximal (laser) end to the distal (coil) end, providing the strength and torqueability necessary to push the SMP expandable coil up to and through the occlusion and to retract the device. The stiffness of the windings may vary along the length of the fiber to enhance maneuverability (stiffer at proximal end, more flexible at distal end).
Referring now to
The structural components of the shape memory polymer coil mounted on a radially diffusing optical fiber 800 having been described and illustrated in
Referring now to
The structural components of the extruded strand of thermoplastic SMP 900 having been described and illustrated in
Referring now to
The structural components of the coil design having resistive heating actuation 1000 having been described and illustrated in
A flexible, resistive element 1003 (e.g., loop of NiCr wire or flexible graphite) is coated with or embedded in the thermosetting or thermoplastic SMP 1001. The resistive element 1003 may be coated with the SMP 1001 using various techniques (e.g., dip-coating or powder deposition) or embedded into the SMP 1001 during an injection-molding process or by co-extrusion. The thickness of the overlying SMP 1001 must be sufficient to coerce the encompassed resistive element 1003 into the expanded coil form upon actuation. The SMP 1001 containing the resistive element 1003 is wrapped around a conical mandrel and heated to set the primary “corkscrew” shape. The SMP coil 1001 is mounted on the distal end of a guide wire 1002 long enough to extend through the catheter up to the occlusion. Leads 1004 running from a power supply 1005 (external to the body) extend through the guidewire 1002 and are connected to the exposed terminals of the resistive element 1003 at the proximal end of the SMP 1001. Actuation into the expanded coil form is achieved by applying a voltage to drive a current through the resistive element 1003, causing it to heat the SMP 1001 above its transition temperature.
Referring now to
The structural components of the SMP basket 1100 having been described and illustrated in
The SMP basket is designed in a way that allows it to be heated and reformed or consolidated from its primary “open basket” shape shown in
Referring now to
The structural components of the SMP basket 1200 having been described and illustrated in
The SMP basket is designed in a way that allows it to be heated and reformed or consolidated from its primary “open basket” shape into a secondary tubular shape shown in
The first step in the fabrication of the SMP basket is to mold the basket structure as a two-dimensional part. The mold is fabricated by chemically etching or machining the grooves that will form the structure into a flat plate. This mold plate is then clamped between two ridged plates to form the completed mold. There is a port in the center of one of the outside plates to allow the injection of the uncured thermosetting SMP. The filled mold is allowed to rest at room temperature temporarily and then heated to accelerate curing of the SMP. Injection molding a thermoplastic SMP is also feasible.
Referring now to
The structural components of the SMP basket 1300 having been described and illustrated in
The fabrication process involves forming the two-dimensional (as molded) part 1300 into the three-dimensional primary “open basket” shape 1102 using a mandrel (male) and die (female) in the shape of the desired structure. The two-dimensional part 1300 is placed into the die and heated to soften the SMP. The mandrel is heated separately and then placed into the heated die, capturing the two-dimensional part between the die and the mandrel and forcing it into the “open basket” shape. The assembled mold is then heated above the highest glass transition temperature of the SMP and cooled to set the primary shape. The last step in the fabrication process is to form the SMP basket 1102 into the secondary tube shape 1200 that will act as an extension of the catheter prior to actuation. The part is placed on a mandrel that is heated slightly above the soft phase glass transition temperature of the SMP (to soften the SMP) and pulled through a series of heated tubes. This process is repeated as the size of the mandrel and tubes are reduced until the final, fully collapsed tube shape 1200 is formed.
Referring now to
The structural components of the embodiment 1400 having been described and illustrated in
Referring now to the drawings and in particular to
The structural components of the shape memory polymer basket 1500 having been described and illustrated in
Alternatively, saline could be injected through the catheter 1501 which would be heated by the resistive element 1503 and in turn would heat the SMP basket 1502 as it passes out of the catheter 1501, causing it to expand into the “open basket” shape. In the SMP basket with a heated saline flush system 1500, the electrical heating element 1503 (or series of heating elements) is placed inside the distal end of the catheter 1501 to which the SMP basket is mounted. The element(s) 1503 is positioned to allow delivery of the SMP coil device through the catheter 1501. A saline bolus is slowly pushed through the catheter 1501 and heated by the heating element(s) 1503 as it exits the catheter 1501 and passes by the attached SMP basket in its tube form. The heated saline actuates the basket into its “open basket” form.
Referring now to the drawings and in particular to
The structural components of the hollow-core SMP coil with a heated saline flush system 1600 having been described and illustrated in
Referring now to the drawings and in particular to
The structural components of the shape memory polymer coil 1700 having been described and illustrated in
Referring now to
The structural components of the SMP basket with a removable diffusing optical fiber 1800 having been described and illustrated in
Referring now to the drawings and in particular to
The structural components of the shape memory polymer basket 1901 and the shape memory polymer expandable coil 1902 having been described and illustrated in
Alone, the SMP coil 1902 and basket 1901 are capable of one-way actuation; that is, upon heating, they change from the stable secondary shape to the primary shape. The coil 1902 will change from a straight rod shape into the “corkscrew” shape and the basket 1901 will change from the “closed” tube form to the “open” basket form. However, both of these devices can be reset into their original secondary shapes and re-deployed if necessary, without the need to withdraw the devices from the body. This is accomplished by using the catheter 1903 and guide catheter 1904 as a sheath to constrain the SMP coil and basket devices, respectively, while they are being heated (independent of the type of heating mechanism). For example, the coil device may be re-heated after previous actuation and retracted back into the catheter. Because the SMP softens when heated, it will straighten as it is pulled back into the catheter. Once it is fully constrained, the heating source is turned off, causing the device to resume its straight form. Likewise, the “open” SMP basket may be retracted back into the guide catheter while it is heated, causing it to resume its “closed” tube form. Conceivably, separate “sheathing devices” could be incorporated rather than using the catheters themselves to act as the sheaths.
Referring now to the drawings and in particular to
In order to increase the shape recovery force of an SMP actuator/device, a material 2001 (e.g., metal wire, elastic or superelastic metal wire, shape memory alloy, or other non-metal material) configured such that when deformed it tends to resume its original shape is incorporated into the SMP device. The recovery enhancing material can be inside (e.g., embedded in) or outside (e.g., attached to or encasing) the SMP portion of the device 2002. The preferred shape of this recovery enhancing material corresponds to the desired recovered shape of the SMP device.
As illustrated in
Referring again to the drawings and in particular to
Due to the narrow (3-hour) treatment window for effective use of the thrombolytic drug recombinant tissue-type plasminogen activator (rt-PA), there is a need to develop alternative treatments for ischemic stroke. The shape memory polymer expandable coil 2100 system provides an intravascular device for mechanical thrombus removal using shape memory polymer (SMP). The shape memory polymer expandable coil 2100 system makes it possible to deliver the SMP microactuator 2101 in its secondary straight rod form (length=4 cm, diameter=350 μm) illustrated in
The only approved treatment for acute ischemic stroke is intravenous administration of recombinant tissue-type plasminogen activator (rt-PA). This thrombolytic drug, which is infused over a 1 hour period, restores blood flow by chemically dissolving the thrombus following ischemic stroke. A Phase III multicenter clinical trial demonstrated beneficial outcomes when rt-PA was administered within 3 hours of the onset of stroke symptoms, though patients treated within 90 minutes showed the most benefit. In a separate Phase III trial, patients treated 3-5 hours after symptom onset showed no benefit, confirming that rt-PA should only be administered within 3 hours. However, the majority of patients are not eligible to receive intravenous rt-PA, mainly due to delays in obtaining treatment. Additional drawbacks of rt-PA include the relatively high risk of intracranial hemorrhage, the numerous contraindicafions prohibiting treatment, and the extensive patient follow-up monitoring and care associated with systemic thrombolytic drug exposure. A potential alternative to rt-PA is mechanical removal of the thrombus using the microdevice 2100 deployed endovascularly. The microdevice 2100 provides a catheter-based SMP device to capture and remove the thrombus 2102 and restore blood flow following ischemic stroke.
The microdevice 2100 was fabricated using a commercially available thermoplastic SMP (MM5520, DIAPLEX Company, Ltd., a subsidiary of Mitsubishi Heavy Industries, Ltd., Tokyo, Japan). Recovery of the stable primary shape is achieved by controlled heating of the SMP in its stable secondary shape. While heated above its highest glass transition temperature (Tg≈130° C.), the SMP is formed into the primary shape and cooled to stabilize the shape. At a temperature above its soft phase glass transition temperature (Tgs=55° C.), the SMP is deformed into a secondary shape and then cooled. The primary shape is recovered by heating again to Tgs.
The present invention provides an endovascular thrombus removal system using a SMP micoroactuator. The endovascular thrombus removal system comprises a transport vehicle, a shape memory material operatively connected to said transport vehicle, said shape memory material adapted to move from a first shape that can be moved through said vessel, to a second and different shape for acting upon said thrombus, and a heat transfer mechanism operatively connected to said shape memory material, adapted to transfer heat to said shape memory material to move said shape memory material from said first shape to said second shape. The figures of drawings 1-21, and in particular FIGS. 3A-C and FIGS. 21A-C, provide embodiments illustrating principles of operation of the endovascular thrombus removal system. For example, as illustrated in FIGS. 21A-C, the microactuator 2100 is delivered through a catheter distal to the vascular occlusion 2102. The distal end of the microactuator 2100 penetrates the occlusion 2102. The rod 2101 is transformed into its primary corkscrew shape by laser heating as shown in
Individual embodiments of the microactuator were constructed and tested. In the microactuator fabrication, raw SMP material was extruded into a strand with circular cross-section approximately 350 μm in diameter. A cylindrical rod segment approximately 4 cm in length was obtained. In one end of the segment, a hole (diameter=127 μm, depth=1 mm) was drilled coaxial with the longitudinal axis of the rod. A multimode ultra low-OH 100 μm core diameter (125 μm diameter including the polyimide buffer) step-index silica core/silica clad optical fiber (FIP100110125, Polymicro Technologies, Phoenix, Ariz.) was cleaved on one end (numerical aperture=0.22). The other end (terminated with an ST connector) was coupled to a pigtailed 800 nm diode laser (H01-A001-800-FC/100, Opto Power Corporation, Tucson, Ariz.). The cleaved end of the fiber was inserted into the drilled socket in the SMP rod and secured with a fast-setting epoxy (Double-Bubble Red #04001, Hardman, Inc., Belleville, N.J.) around the joint. The tip of the drill bit used to create the socket was slightly convex, resulting in a small air gap between the cleaved fiber tip and the SMP.
An illustration of the fiber-SMP joint is illustrated in
After the epoxy was fully cured, the SMP rod was wrapped around a cone-shaped aluminum mandrel illustrated in
The circular cross-section of the SMP microactuator enhances its waveguiding ability, enabling light to propagate along its entire length with minimal loss due to leakage. In order to increase absorption of the 800 nm diode laser light and enhance heating, the SMP rods were doped with indocyanine green (ICG) dye (Sigma Chemical Co., St. Louis, Mo.) which has a strong absorption peak near 800 nm. Prior to drilling the hole in the SMP rod, the rod was soaked in a solution of ICG dye and methanol, allowing the ICG dye to diffuse into the SMP, and then vacuum dried to remove the methanol. The concentration of ICG in the SMP rod was estimated based on the ICG concentration in the methanol and amount of methanol that diffused into the SMP; the ICG concentration in the SMP was assumed to be uniform. Rods with ICG concentrations from approximately 0.08 to 4.7 μM were made.
The absorption coefficient of the ICG-doped SMP was calculated for various ICG concentrations. Using a spectrophotometer (Cary 300, Varian Instruments, Walnut Creek, Calif.), the spectral absorbance of thin samples of thermoset SMP (MP5510, DIAPLEX Company, Ltd.) with various ICG dye concentrations (0-40.6 μM) was measured. The thermoset material, which is easily molded into thin films unlike the thermoplastic material used for the device, was used to facilitate fabrication of the samples. Also, because it is in a liquid state prior to curing, the ICG dye was added directly to the uncured material, allowing uniform distribution of the dye and accurate control of the concentration. After removing the contribution from reflective losses inherent in the measurement, the absorbance data were used to calculate the absorption coefficient, μa, at the laser wavelength (800 nm) as a function of ICG dye concentration:
where A is the absorbance, d is the sample thickness, and In is the natural logarithm (ln 10=2.303). The absorption coefficient varies linearly with absorbance.
In order to estimate the absorption of ICG-doped thermoplastic, the absorbance of a thin sample of thermoplastic SMP without dye was measured. Because the absorbance value at 800 nm was within the noise level of the measurement (i.e., reflective losses exceeded actual absorption), it was estimated to be zero. In contrast, the thermoset material without dye had measurable (nonzero) absorbance at 800 nm. Assuming the dependence of absorbance on dye concentration is the same for thermoplastic and thermoset SMP, the thermoset absorption coefficient versus dye concentration curve was simply shifted down to intercept the origin to estimate the thermoplastic absorption.
Because the photon mean free path (i.e., the average distance a photon will travel before being absorbed, ignoring scattering) is simply the reciprocal of the absorption coefficient, the absorption coefficient provides information regarding the penetration depth of the light in ICG-doped SMP. Ignoring loss mechanisms other than absorption, the amount of light decreases exponentially with distance into the SMP:
i. T=exp(−μad) (2)
where T is the fraction of light transmitted and d is the distance traveled. At a distance equal to the photon mean free path (d=1/μa), the amount of light drops to 37% (T=0.37).
An infrared camera (Thermacam PM250, Inframetrics, Billerica, Mass.) with a close-up lens was used to measure the temperature of the SMP rod upon laser heating. For these experiments, the corkscrew shape was not set and the rod was left in its straight form to eliminate movement during heating and facilitate temperature measurement along its length. Temperature distributions were observed for various ICG dye concentrations and laser powers.
Because laser light is used to actuate the device, its success depends on the ability of the SMP to behave as a waveguide. In its straight form, the cylindrical SMP rod suffers no leakage, much like an optical fiber. However, because laser heating must continue as the SMP changes shape, ZEMAX optical design software (ZEMAX Development Corporation, San Diego, Calif.) was used to model the light transmission from the optical fiber through the SMP microactuator in its corkscrew form. Light loss due to leakage out of the SMP was estimated for device actuation in air and in blood. Because the actuation occurs as the SMP transforms, modeling the light propagation in its corkscrew form represents a worst-case scenario (i.e., the microactuator is initially straight when laser actuation begins).
In order to assess the feasibility of using the 100 μm core optical fiber in the tortuous paths encountered in the neurovasculature, the transmission of 800 nm laser light through a single 360° loop of the optical fiber was measured for various loop radii down to 1 mm. The amount of light exiting the looped fiber relative to the amount of light exiting the straight (no loop) fiber was measured using a power meter (LabMaster-E, Coherent, Inc., Santa Clara, Calif.) with a thermal sensor (LM-10, Coherent, Inc.).
The spectral absorption of the thermoset SMP doped with ICG dye at concentrations from 0 to 40.6 μM is shown in
Referring now to
Referring now to
Observation of the straight SMP rod during laser heating with the thermal camera showed that the axial heat distribution depended on the ICG dye concentration. Lower dye concentrations resulted in more uniform axial laser heating along the straight SMP rod. However, the temperature at the fiber-SMP joint was sometimes independent of the dye concentration, reaching unexpectedly high temperatures even at the lowest dye concentration. In some cases, the elevated temperature at the joint approached or exceeded Tg, causing irreversible deformation and/or thermal damage of the SMP, which resulted in light leakage. It is likely that laser light back-reflected from the air-SMP boundary at the end of the drilled socket (Fresnel reflection due to index mismatch) was absorbed by the epoxy, causing the temperature in the vicinity of the joint to rise excessively. To test this hypothesis, several joints were created using an index-matched optically transparent epoxy (EPOTEK 301-2, Epoxy Technology, Inc., Billerica, Mass.) applied in the socket, eliminating the air gap between the cleaved tip of the optical fiber and the SMP. Excessive heating at the joint was not evident in these samples, suggesting that the combination of the air gap and highly absorbing epoxy was responsible for the elevated temperature at the joint.
To elicit the dependence of temperature on ICG dye concentration and laser power, the temperature was measured at a point approximately 1 cm from the proximal (joint) end of the straight SMP rod for various dye concentrations as the laser power was slowly ramped up as shown in
where P0 is the laser power output from the optical fiber, a is the fraction of light transmitted into the SMP (α<1 due to Fresnel reflection and light leakage at the air gap in the socket), and Acs is the cross-sectional area of the SMP rod; the exponential accounts for the attenuation of the fluence due to absorption given by equation (2). Due to the inconsistent coupling of the laser light into the SMP (i.e., the value of α potentially varied from one experiment to the next), the slopes of the curves in
Referring now to
The optimal dye concentration which minimizes the amount of laser power required to heat the SMP to a given temperature can be derived theoretically. Rearranging equation (3), noting that the temperature increase is directly proportional to the absorbed photon energy, and using the linear relationship between the absorption coefficient and the dye concentration shown in
Referring now to
Because more laser power is needed to achieve actuation of the SMP distally (farther from the fiber-SMP joint) versus proximally, a laser power must be chosen to achieve sufficient heating distally. As a result, proximal temperatures are higher than necessary. A non-uniform dye concentration in which the concentration gradually increased with distance from the joint would require less laser power and result in a more uniform axial temperature distribution. The optimal axial concentration profile is determined by rearranging equation (3) and using the linear relationship in
where Pmin0=3.37 is the minimum value of P 0 at d=4 cm, obtained by evaluating the expression in equation (4) at C=1/(0.31d), where d=4.
Referring now to
Successful laser actuation of the SMP device (i.e., complete recovery of the primary corkscrew shape) was achieved in air at ICG dye concentrations from 0.08 to 1.56 μM using laser powers from approximately 900 to 1100 mW. Higher and lower dye concentrations were not tested. Due to the excessive heating at the fiber-SMP joint, intermittent failures (partial or no actuation due to thermal deformation or damage of the SMP) also occurred at these dye concentrations.
A three-dimensional ray trace diagram illustrating light propagation through the SMP corkscrew was made. An air gap of 0.01 mm in the drilled socket between the cleaved tip of the optical fiber and the SMP was modeled, but the convex nature of the socket was not (it was assumed to be flat). Most of the 20 randomly selected light rays emitted by the optical fiber (numerical aperture=0.22) exit the SMP at the distal end, though some leak out early. Virtual detectors were placed along the SMP to monitor the amount of light at each location on the corkscrew.
A ZEMAX three-dimensional ray trace diagram of laser light propagation through the SMP microactuator in its corkscrew shape was made. The optical fiber entered the SMP at the end of the corkscrew. This ray trace was generated for a 0.01 mm air gap in the drilled socket between the cleaved tip of the optical fiber and the SMP, assuming the SMP device is in air. Virtual detectors placed along the corkscrew monitored the amount of light at each location to determine the effect of filling the air gap with a material with the same index of refraction as the SMP. As shown in
The transmission of 800 nm laser light through the optical fiber with a single 360° loop versus loop curvature is shown in
Referring now to
While the invention may be susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and have been described in detail herein. However, it should be understood that the invention is not intended to be limited to the particular forms disclosed. Rather, the invention is to cover all modifications, equivalents, and alternatives falling within the spirit and scope of the invention as defined by the following appended claims.
This application is a Continuation-in-Part of co-pending U.S. patent application Ser. No. 10/713,622 filed Nov. 13, 2003, titled, “Shape Memory Polymer Actuator and Catheter” published as United States Patent Application No. 2004/0133231 Jul. 8, 2004. U.S. patent application Ser. No. 10/713,622 is incorporated herein in its entirety by this reference. This application claims the benefit of U.S. Provisional Patent Application No. 60/641,961 filed Jan. 6, 2005 and titled “Shape Memory Polymer Device for Occlusion Removal.” U.S. Provisional Patent Application No. 60/641,961 filed Jan. 6, 2005 and titled “Shape Memory Polymer Device for Occlusion Removal” is incorporated herein by this reference.
The United States Government has rights in this invention pursuant to Contract No. W-7405-ENG-48 between the United States Department of Energy and the University of California for the operation of Lawrence Livermore National Laboratory.
| Number | Date | Country | |
|---|---|---|---|
| 60641961 | Jan 2005 | US |
| Number | Date | Country | |
|---|---|---|---|
| Parent | 10713622 | Nov 2003 | US |
| Child | 11172668 | Jun 2005 | US |
