Patent Application
20080039728
In certain aspects of the invention, the systems include a catheter with a lumen that extends within the catheter and an aperture that extends from an outer surface of the catheter to the lumen. A waveguide is disposed within the lumen of the catheter, and at least a portion of the waveguide is exposed via the aperture to environment exterior to the catheter. In some embodiments, the catheter is configured to limit (e.g., prevent) proximal movement, distal movement, and/or transverse movement of a distal end region of the waveguide (e.g., a portion of the waveguide located distal to the aperture) relative to the catheter.
Referring to
Referring to
In some embodiments, first and second transformer sections 118, 120 and flexible wire 122 are formed of 6Al-4V titanium alloy. Alternatively or additionally, first and second transformer sections 118, 120 and flexible wire 122 can include one or more other materials, such as titanium, other titanium alloys, stainless steel, and/or stainless steel alloys. First and second transformer sections 118, 120 and flexible wire 122 can be formed from a unitary rod that is ground to the desired dimensions. Alternatively, first transformer section 118, second transformer section 120, and/or flexible wire 122 can be discrete components that are secured (e.g., welded) to one another.
Distal tip 124 is formed of a highly radiopaque material, such as tantalum, platinum, iridium, and/or combinations of these materials. Distal tip 124 can be secured to the distal end of flexible wire 122 using any of various techniques, such as welding, thermally bonding, etc. During use, distal tip 124 can be used to help position waveguide 112 as desired within a blood vessel by, for example, using an imaging technique, such as fluoroscopy.
Due to the configuration and materials of waveguide 112, a longitudinal vibration applied to the proximal end of waveguide 112 (e.g., to the proximal end of first transformer section 118 of waveguide 112) can be amplified by first and second transformer sections 118, 120, and the amplified longitudinal vibration can be transferred to flexible wire 122, causing flexible wire 122 to buckle. As a result, a standing transverse wave can be created along flexible wire 122. The standing transverse wave can create multiple nodes and anti-nodes of transverse vibration along flexible wire 122.
A distal end region 134 of waveguide 112 is made up of distal tip 124 and the enlarged distal end of flexible wire 122. Distal end region 134 has a diameter mat is greater (e.g., about 0.006 inch greater) than the portion of waveguide 112 immediately proximal to distal end region 134.
Referring again to
A distal end 136 of aperture 110 is located in relatively close proximity to a distal end 138 of catheter 102 and to distal end region 134 of waveguide 112. In some embodiments, for example, distal end 136 of aperture 110 is located about five centimeters or less (e.g., about one centimeter to about five centimeters, about 2.5 centimeters) from distal end 138 of catheter 102. Locating distal end 136 of aperture 110 in close proximity to distal end 138 of catheter 102 and in close proximity to distal end region 134 of waveguide 112 can help to ensure that a substantial portion of flexible wire 122 of waveguide 112 is exposed to the environment exterior to catheter 102 via aperture 110. This can help to increase the amount of vibrational energy resulting from transverse vibration of flexible wire 122 that is emitted through aperture 110 during use.
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Referring to
The configuration of region 146 of waveguide lumen 104 can reduce (e.g., minimize) transverse movement of distal end region 134 of waveguide 112, while permitting distal end region 134 of waveguide 112 to slide axially within region 146 of waveguide lemon 104. The configuration of region 146 of waveguide lumen 104 can, for example, reduce transverse movement of distal end region 134 of waveguide 112 to about 0.020 inch or less (e.g., about 0.0005 inch to about 0.020 inch, about 0.0005 inch to about 0.002 inch, about 0.001 inch). Restricting transverse movement of distal end region 134 of waveguide 112 can help to maintain stress levels in waveguide 112 within a desirable or acceptable range. The stress levels can, for example, be maintained within a range in which the physical properties of waveguide 112 remain substantially unchanged during use. At the same time, allowing distal end region 134 of waveguide 112 to slide axially along the length of region 146 of waveguide lumen 104 can facilitate navigation of system 100 through a blood vessel by, for example, decreasing resistance experienced by system 100 when catheter 102 and waveguide 112 are navigated around bends within the blood vessel.
As shown in
Projection 148 can be integrally formed with the side wall 108 of catheter 102. Projection 148 can, for example, be formed by pressing a hot knife radially against the outer surface of catheter 102. Such a technique forms a depression in the outer surface of catheter 102, causing projection 148 to extend radially into waveguide lumen 104. Alternatively or additionally, any of various other suitable techniques can be used to form projection 148. For example, a mandrel having a portion with an outer diameter that is smaller than the outer diameter of the distal tip 124 of waveguide 112 can be disposed within a lumen of a catheter tube and a heat shrink tube can be disposed around an outer surface of the catheter tube, and then the assembly can be heated such that the portion of the lumen surrounding small diameter portion of the madrel is reduced to a diameter that is less than the diameter of distal tip 124.
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Because distal end region 134 of waveguide 112 is prevented from extending into the portion of waveguide lumen 104 adjacent aperture 110 and is prevented from extending distally beyond distal end 138 of catheter 102, the distal end of waveguide 112 can be prevented from contacting a blood vessel wall during delivery of system 100 through a blood vessel and during treatment of the blood vessel using system 100.
Referring again to
Catheter 102 can be any of various different sizes, depending on its intended use. In general, catheter 102 can have an outer diameter of about 0.013 inch to about 0.260 inch and/or a length of about 25 centimeters to about 150 centimeters. In some embodiments, catheter 102 is sized for use in a femoral artery. In such embodiments, catheter 102 can have an outer diameter of about 0.052 inch to about 0.078 inch and a length of about 80 centimeters to about 100 centimeters. In certain embodiments, catheter 102 is sized for use in neuro blood vessels, in which case catheter 102 can have an outer diameter of about 0.026 inch to about 0.039 inch and a length of about 25 centimeters to about 60 centimeters.
In some embodiments, catheter 102 is termed of multiple different materials along its length. For example, catheter 102 can be formed of multiple different materials along its length so that the durometer of catheter 102 decreases from its proximal end to its distal, end such that catheter 102 is more flexible near its distal end than near its proximal end. In such embodiments, catheter 102 can be constructed of multiple longitudinal segments of differing durometer that are attached (e.g., bonded) to one another to form catheter 102. In some embodiments, for example, catheter 102 includes polyether block amides (e.g., PEBAX®) of differing durometers. Any of various manufacturing techniques, such as extrusion and/or injection molding, can be used to manufacture the longitudinal segments of catheter 102.
As an alternative to being formed of multiple segments, catheter 102 can be formed as a unitary member, for example, using coextrusion techniques. Moreover, while catheter 102 has been described has including multiple different materials of differing durometer, catheter 102 can alternatively be formed of a single, relatively flexible material, such as a polyether block amide of a desired durometer.
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Handpiece 114 includes a housing assembly 164 that includes a main body portion 166 and a nosecone portion 168. Nosecone portion 168 includes threads 170 that mate with threads 172 on a distal end region of main body portion 166 to secure nosecone potion 168 to main body portion 166. Nosecone portion 168 is tapered from its proximal end to its distal end. The distal end region of nosecone portion includes an annular, inwardly extending projection 174 that is disposed within annular recess 162 of adaptor 152. Nosecone portion 168 can be formed of a resilient material such that, when nosecone portion 168 is slid onto adaptor 152, the distal end region of nosecone portion 168 deflects outward and, upon reaching annular recess 162 of adaptor 152, annular projection 174 of nosecone portion 168 snaps into annular recess 162. Annular recess 162 of adaptor 152 and annular projection 174 of nosecone portion 168 cooperate to longitudinally fix handpiece 114 to adaptor 152 while allowing adaptor 152 to rotate relative to handpiece 114. Because adaptor 152 is fixed to catheter 102, catheter 102 is similarly longitudinally fixed relative to handpiece 114 and rotatable relative to handpiece 114.
Vibration-generation assembly 116 includes an ultrasonic horn 176 having a front portion 182 and a back mass. Two piezeoceramic rings 178, 180 are disposed between front portion 182 and back mass 184 of horn 176. Piezeoceramic rings 178, 180 are held tightly together between front portion 182 and back mass 184 of horn 176 by a bolt 186 extending through central apertures of piezeoceramic rings 178, 180. Front portion 182 of born 176 includes a threaded region 183 that is used to secure front portion 182 of horn 176 to waveguide 112. Back mass 184 of horn 176 is secured (e.g., bonded) to the proximal end of main body portion 166 of housing assembly 164. As a result, horn 176 is axially fixed relative to housing assembly 164 of handpiece 114.
During use, piezeoceramic rings 178, 180 are electrically connected to an electrical power supply (not shown). Piezeoceramic rings 178, 180 are configured so that, when electrical energy is received from the power supply, piezeoceramic rings 178, 180 vibrate (e.g., ultrasonically vibrate) in a longitudinal direction. The vibrational energy emitted by piezeoceramic rings 178, 180 causes horn 176 to similarly vibrate in a longitudinal direction.
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Waveguide 112 is axially fixed to handpiece 114 by vibration-generating assembly 116. As noted above, catheter 102 is also axially fixed to handpiece 114 by adaptor 152. As a result, waveguide 112 and catheter 102 can be axially secured relative to one another in a predetermined configuration. For example, catheter 102 and waveguide 112 can be configured so that the active region of waveguide 112 (e.g., flexible wire 122, which vibrates transversely during use) is located adjacent aperture 110 and transformer sections 118, 120 are located proximal to aperture 110. The configuration of catheter 102 allows waveguide 112 and catheter 102 to remain substantially axially fixed relative to one another throughout use. Because aperture 110 permits vibrational energy transmitted by waveguide 112 to pass through side wall 108 of catheter 102, waveguide 112 can be positioned in substantially the same position relative to catheter 102 when delivered through a patient's blood vessel and when vibrated to treat the patient's blood vessel. For example, waveguide 112 need not be extended distally beyond the distal end of catheter 102 while treating the blood vessel and waveguide 112 need not be retracted proximally relative to catheter 102 prior to being delivered through the blood vessel.
Referring to
Referring to
Because distal end region 134 of waveguide 112 is enclosed within distal portion 142 of catheter 102, distal end region 134 of waveguide 112 is prevented from contacting the wall of blood vessel 198 during treatment. Similarly, during treatment, waveguide 112 is prevented from contacting guide wire 196 by a wall 109 of catheter 102 that physically separates waveguide lumen 104 from guide wire lumen. Thus, the physician does not typically need to retract or remove guide wire 196 prior to activating waveguide 112.
Due to the size of aperture 110 relative to the size of flexible wire 122 of waveguide 112, as waveguide 112 is vibrated, a portion of flexible wire 122 can bow radially outward through aperture 110. The proximity of flexible wire 122 relative to the wall of blood vessel when flexible wire 122 bows outward through aperture 110 can result in occluded region 199 being treated with vibrational energy of increased intensity, as compared to treatments in which a waveguide remains entirely within a catheter during treatment. Thus, this arrangement can increase speed and efficiency of the treatment performed to remove occluded region 199.
While vibrating waveguide 112, catheter 102 is rotated to expose the portion of waveguide 112 adjacent aperture 110 (e.g., flexible wire 122 of waveguide 112) to various different regions (e.g., circumferentially spaced regions) of blood vessel 198, allowing the various different regions within blood vessel 198 to be treated. In some embodiments, for example, catheter 102 is rotated 360 degrees. This can help to ensure that occluded region 199 of blood vessel 198 is removed from substantially the entire inner circumference of blood vessel 198. The physician can also move system 100 back and form (forward and backward) through occluded region 199 during use.
In some embodiments, during use, a cooling and/or lubricating fluid is passed through waveguide lumen 104. The fluid can, for example, be injected into waveguide lumen 104 via luer lock fitting 158 of adaptor 152. The fluid can help to maintain the temperature of waveguide 112 within a desired or acceptable temperature range during treatment. Alternatively or additionally, a radiopaque contrast fluid can be passed through waveguide lumen 104 dining use.
Referring to
Blood vessel 198 can be any of various different types of blood vessels. For example, blood vessel 198 can be a femoral blood vessel (e.g., a femoral artery) or a neuro blood vessel.
While certain embodiments have been described, other embodiments are possible.
As an example, while catheter 102 has been described as including a discrete projection configured to limit proximal movement of waveguide 112 relative to catheter 102, any of various other retention features can be used to limit proximal movement of waveguide 112 relative to the catheter. As shown in
As shown in
As an alternative to or in addition to disposing a tube within waveguide lumen 304 to limit proximal movement of waveguide 112 relative to catheter 302, a ring can be disposed within waveguide lumen 304 to achieve a similar result.
In certain embodiments, a proximal region of the distal portion of the catheter is configured so that a portion of the waveguide lumen proximal to distal end region 134 of waveguide 112 has a smaller diameter than distal end region 134 of waveguide 112. In such embodiments, the catheter can be molded using a molding mandrel having a region of decreased outer diameter for molding the portion of the catheter to be positioned proximal to distal end region 134 of waveguide 112 and a region of increased diameter for molding the portion of the catheter in which distal end region 134 of waveguide 112 is to be disposed. To assemble the system, distal end region 134 of waveguide 112 can be forced distally through the smaller diameter portion of the waveguide lumen and into the larger diameter portion of the waveguide lumen. The smaller diameter portion of the waveguide lumen can be sized so that the force required to pull waveguide 112 proximally through the smaller diameter portion is greater than forces likely to be encountered by the system. As a result, this arrangement can limit proximal movement of distal end region 134 of waveguide 112 during use.
As an additional example, while embodiments discussed above include retention features (e.g., projection 148, annular projection 248, tube 348) as extending inwardly from a distal portion of the catheter (e.g., a portion of the catheter that is located distal to the aperture), the retention features can alternatively or additionally extend from a different region of the catheter. In some embodiments, for example, the retention feature extends radially inward from a region of the catheter adjacent the aperture. In such embodiments, the retention feature can be axially spaced from the distal end of the aperture by less than the length of distal end region 134 of waveguide 112 to prevent distal end region 134 of waveguide 112 from exiting radially through the aperture during use.
As shown in
As another example, while catheters of certain embodiments discussed above have been described as including a waveguide lumen with a reduced diameter portion distal to distal end region 134 of waveguide 112 to limit (e.g., prevent) distal movement of waveguide 112 relative to the catheter during use, any of various other techniques can be used to limit distal movement of waveguide 112 relative to the catheter. For example, any of the various retention features (e.g., projections, tubes, rings, sleeves, etc.) described above for limiting proximal movement of waveguide 112 relative to the catheter, can be positioned within a portion of the waveguide lumen distal to waveguide 112 to limit distal movement of waveguide 112 relative to the catheter.
Other techniques can alternatively or additionally be used to limit proximal and/or distal movement of waveguide 112 relative to the catheter. As shown in
As an additional example, while the waveguide lumens of catheters of certain embodiments discussed above have been described as extending through the entire length of the catheter, the waveguide lumen can alternatively be a blind lumen that terminates proximal to the distal end of the catheter. Such an arrangement can prevent waveguide 112 from extending distally beyond the distal end of the catheter during use.
As another example, while catheters of certain embodiments discussed above have been described as being configured to limit both proximal and distal movement of waveguide 112 relative to the catheter, in some embodiments, the catheter is configured to limit only proximal movement of waveguide 112 relative to the catheter or only distal movement of waveguide 112 relative to the catheter.
As an additional example, while the catheters of the embodiments discussed above are configured to limit proximal movement of distal end region 134 of waveguide 112 relative to the catheter, the catheters can alternatively be configured to allow distal end region 134 of waveguide 112 to move proximally relative to the catheter without limitation. Referring to
As a further example, while catheters of certain embodiments discussed, herein are described as including a guide wire lumen extending along side only a distal portion of a waveguide lumen, the guide wire lumen can alternatively or additionally extend along side other regions of the waveguide lumen. For example, the guide wire lumen can extend along side proximal and/or central regions of the waveguide lumen. In some embodiments, the guide wire lumen extends along side substantially the entire length of the waveguide lumen.
As another example, while certain embodiments have been described in which the catheter includes a waveguide lumen and a guide wire lumen, the catheter can include fewer or greater lumens. In some embodiments, for example, the catheter includes only a waveguide lumen. In certain embodiments, in addition to the waveguide lumen and the guide wire lumen, the catheter includes an aspiration lumen and/or a flushing lumen.
As an additional example, while waveguide 112 has been described as including an active section that vibrates in the transverse direction, waveguide 112 can alternatively or additionally be configured so that the active region vibrates in a longitudinal and/or torsional direction.
As another example, while waveguide 112 has been described as having certain dimensions, waveguide can have any of various different dimensions that allow waveguide to vibrate in a desired manner. Flexible wire can, for example, have a diameter of about 0.002 inch to about 0.040 inch (e.g., about 0.004 inch to about 0.017 inch) and a length of about ten centimeters to about 200 centimeters (e.g., about 60 centimeters to about 110 centimeters). Distal end region 134 of waveguide 112 can have a diameter of about 0.002 inch to about: 0.020 inch (e.g., about 0.004 inch to about 0.010 inch) and a length of about 0.5 centimeter to about 20 centimeters (e.g., about one centimeter to about ten centimeters). Any of the various other parts of waveguide 112 can similarly have different dimensions depending, for example, on the intended use of waveguide 112.
While distal end region 134 of waveguide 112 has been described as being composed of distal tip 124 and the enlarged distal end of flexible wire 122, in some embodiments, the waveguide is configured so that the distal end region of the waveguide is made up entirely of the distal tip. In such embodiments, the flexible wire can include a distal end portion that has a diameter that is substantially equal to the diameter of the remainder of the flexible member, and the distal tip can have a diameter that is greater than the diameter of the distal end portion of the flexible member.
As another example, while the distal end region of the waveguide in embodiments discussed above is substantially cylindrical, the distal end region of the waveguide can alternatively or additionally be any of various other shapes. As shown in
While the catheter of certain embodiments discussed above has been described as being rotatable relative to the handpiece, in some embodiments, the catheter is rotationally fixed relative to the handpiece. In certain embodiments, for example, the adaptor that secures the handpiece to the catheter is rotationally fixed relative to both the catheter and the handpiece. The adaptor can, for example, be welded (e.g., ultrasonically welded) to both the catheter and the handpiece.
While adaptor 152 and catheter 102 have been described as being axially fixed to nosecone portion 168 of housing assembly 164 of handpiece 114 using a snap fitting technique, other coupling techniques can alternatively or additionally be used. In some embodiments, for example, nosecone portion 168 is welded (e.g., ultrasonically welded) to adaptor 152. Other examples of coupling techniques include telescopic connections, threaded connections, etc.
While vibration-generating assembly 116 has been described as including piezoceramic rings 178, 180, other types of transducers can alternatively or additionally be used. For example, transducers including one or more other types of materials, such as magnetostrictive materials, can be used. As another example, transducers of other shapes, such as cylindrical transducers and disk-shaped transducers can alternatively or additionally be used.
While system 100 has been described as being used to remove an occluded region of a vessel (e.g., a region occluded with plaque), system 100 can alternatively or additionally be used to perform other types of treatment. For example, system 100 can alternatively or additionally be used to treat (e.g., remove) other types of biological material, such as tissue, cysts, tumors, etc.
While system 100 has been described as being used to perform treatments in various different types of blood vessels, system 100 can alternatively or additionally be used to perform treatments in other types of body vessels or body parts, such as biliary vessels, urethras, uterus, prostates, esophagus, intestines, lymph system, pleural space, sinus. System 100 can similarly be use to perform treatments in other natural orifices, such as ear canals, eye sockets, and the like.
Other embodiments are in the claims.
This application claims priority to U.S. Application Ser. No. 60/780,638, filed Mar. 9, 2006, which is incorporated by reference herein.
| Number | Date | Country | |
|---|---|---|---|
| 60780638 | Mar 2006 | US |
