Shockwave balloon catheter system

Information

  • Patent Grant
  • 10039561
  • Patent Number
    10,039,561
  • Date Filed
    Tuesday, March 17, 2015
    9 years ago
  • Date Issued
    Tuesday, August 7, 2018
    6 years ago
Abstract
A system for breaking obstructions in body lumens includes a catheter including an elongated carrier, a balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The system further includes a power source that provides electrical energy to the arc generator.
Description
BACKGROUND OF THE INVENTION

The present invention relates to a treatment system for percutaneous coronary angioplasty or peripheral angioplasty in which a dilation catheter is used to cross a lesion in order to dilate the lesion and restore normal blood flow in the artery. It is particularly useful when the lesion is a calcified lesion in the wall of the artery. Calcified lesions require high pressures (sometimes as high as 10-15 or even 30 atmospheres) to break the calcified plaque and push it back into the vessel wall. With such pressures comes trauma to the vessel wall which can contribute to vessel rebound, dissection, thrombus formation, and a high level of restenosis. Non-concentric calcified lesions can result in undue stress to the free wall of the vessel when exposed to nigh pressures. An angioplasty balloon when inflated to high pressures can have a specific maximum diameter to which it will expand but the opening in the vessel, under a concentric lesion will typically be much smaller. As the pressure is increased to open the passage way for blood the balloon will be confined to the size of the open in the calcified lesion (before it is broken open). As the pressure builds a tremendous amount of energy is stored in the balloon until the calcified lesion breaks or cracks. That energy is than released and results in the rapid expansion of the balloon to its maximum dimension and may stress and injure the vessel walls.


SUMMARY OF THE INVENTION

The invention provides a catheter that comprises an elongated, carrier, a dilating balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an are generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon.


The at least one electrode may include a single metallic electrode of a pair of metallic electrodes. The electrodes may be radially displaced from each other or longitudinally displaced from each other. The at least one electrode may be formed of stainless steel.


The balloon may be formed of non-compliant material or of compliant material. The dilating balloon may have at least one stress riser carried on its surface.


The catheter may further comprise a sensor that senses reflected energy. The sensor may be distal, to the at least one electrode. The sensor may be disposed on the carrier.


The catheter may further comprise a reflector within, the dilating balloon that focuses the shock waves. The reflector may form one of the at least one electrodes. The catheter has a center line and the reflector may be arranged to focus the shock waves off of the catheter center line.


The fluid may be saline. The fluid may include an x-ray contrast.


The catheter may further include a lumen for receiving a guide wire. The lumen may be defined by the carrier.


The invention further provides a system comprising a catheter including an elongated carrier, a dilating balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The system further comprises a power source that provides electrical energy to the arc generator.


The power source is preferably arranged to provide pulsed high voltage. The power source may be arranged to provide high voltage pulses having selectable pulse durations, selectable voltage amplitudes, and/or selectable pulse repetition rates.


The system may further comprise an R wave detector that synchronizes the mechanical shock waves with cardiac R waves.


The at least one electrode may include a single metallic electrode of a pair of metallic electrodes. The electrodes may be radially displaced from each other or longitudinally displaced from each other. The at least one electrode may be formed of stainless steel.


The balloon may be formed of non-compliant material or of compliant material. The dilating balloon may have at least one stress riser carried on its surface.


The catheter may further comprise a censor that senses reflected energy. The sensor may be distal to the at least one electrode. The sensor may be disposed on the carrier.


The catheter may further comprise a reflector within the dilating balloon that focuses the shock waves. The reflector may form one of the at least one electrodes. The catheter has a center line and the reflector may be arranged to focus the shock waves off of the catheter center line.


The fluid may be saline. The fluid may include an x-ray contrast.


The catheter may further include a lumen for receiving a guide wire. The lumen may be defined by the carrier.


The invention further provides a method comprising the step of providing a catheter including an elongated carrier, a dilating balloon about the carrier in sealed relation thereto, the balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including at least one electrode within the balloon that forms a mechanical shock wave within the balloon. The method further comprises the steps of inserting the catheter into a body lumen of a patient adjacent an obstruction of the body lumen, admitting fluid into the balloon, and applying high voltage pulses to the axe generator to form a series of mechanical shocks within the balloon.


The method may include the further step of detecting cardiac R waves of the patient's heart, and synchronizing the mechanical shocks with the detected R waves.


The method may further include the step of varying one of the repetition rate, amplitude and duration of the high voltage pulses to vary the intensity of the mechanical shock waves.


The method may include the further step of sensing reflected energy within the catheter.


The method may include the further step of placing a guide wire into the body lumen and guiding the catheter into the body lumen along the guide wire.


The method may include the further step of focusing the mechanical shockwaves. The mechanical shockwaves may be focused away from the catheter center axis.


The method may include the further steps of adding an x-ray contrast to the fluid and visualizing the catheter under fluoroscopy.





BRIEF DESCRIPTION OF THE DRAWINGS

For illustration and not limitation, some of the features of the present invention are set forth in the appended claims. The various embodiments of the invention, together with representative features and advantages thereof, may best be understood by making reference to the following description taken in conjunction with the accompanying drawings, in the several figures of which like reference numerals identify identical elements, and wherein:



FIG. 1 is a view of the therapeutic end of a typical prior art over-the-wire angioplasty balloon catheter.



FIG. 2 is a side view of a dilating angioplasty balloon catheter with two electrodes within the balloon attached to a source of high voltage pulses according to one embodiment of the invention.



FIG. 3 is a schematic of a high voltage pulse generator.



FIG. 3A shows voltage pulses that may be obtained with the generator of FIG. 3.



FIG. 4 is a side view of the catheter of FIG. 2 showing an arc between the electrodes and simulations of the shock wave flow.



FIG. 5 is a side view of a dilating catheter with insulated electrodes within the balloon and displaced along the length of the balloon according to another embodiment of the invention.



FIG. 6 is a side view of a dilating catheter with insulated electrodes within the balloon displaced with a single pole in the balloon and a second being the ionic fluid inside the balloon according to a further embodiment of the invention.



FIG. 7 is a side view of a dilating catheter with insulated electrodes within the balloon and studs to reach the calcification according to a still further embodiment of the invention.



FIG. 8 is a side view of a dilating catheter with insulated electrodes within the balloon with raised ribs on the balloon according to still another embodiment of the invention.



FIG. 8A is a front view of the catheter of FIG. 8.



FIG. 9 is a side view of a dilating catheter with insulated electrodes within the balloon and a sensor to detect reflected signals according to a further embodiment of the invention.



FIG. 10 is a pressure volume curve of a prior art balloon breaking a calcified lesion.



FIG. 10A is a sectional view of a balloon expanding freely within a vessel.



FIG. 10B is a sectional view of a balloon constrained to the point of breaking in a vessel.



FIG. 10C is a sectional view of a balloon after breaking within the vessel.



FIG. 11 is a pressure volume curve showing the various stages in the breaking of a calcified lesion with shock waves according to an embodiment of the invention.



FIG. 11A is a sectional view showing a compliant balloon within a vessel.



FIG. 11B is a sectional view showing pulverized calcification on a vessel wall.



FIG. 12 illustrates shock waves delivered through the balloon wall and endothelium to a calcified lesion.



FIG. 13 shows calcified plague pulverized and smooth a endothelium restored by the expanded balloon after pulverization.



FIG. 14 is a schematic of a circuit that uses a surface EKG to synchronize the shock wave to the “R” wave for treating vessels near the heart.



FIG. 15 is a side view, partly cut away, of a dilating catheter with a parabolic reflector acting as one electrode and provides a focused shock wave inside a fluid filled compliant balloon.





DETAILED DESCRIPTION OF THE INVENTION


FIG. 1 is a view of the therapeutic end of a typical prior art over-the-wire angioplasty balloon catheter 10. Such catheters are usually non-complaint with a fixed maximum dimension when expanded with a fluid such as saline.



FIG. 2 is a view of a dilating angioplasty balloon catheter 20 according to an embodiment of the invention. The catheter 20 includes an elongated carrier, such as a hollow sheath. 21, and a dilating balloon 26 formed about the sheath 21 in sealed relation thereto at a seal 23. The balloon 26 forms an annular channel 27 about the sheath 21 through which fluid, such as saline, may be admitted into the balloon to inflate the balloon. The channel 27 further permits the balloon 26 to be provided with two electrodes 22 and 24 within the fluid filled balloon 26. The electrodes 22 and 24 are attached to a source of high voltage pulses 30. The electrodes 22 and 24 are formed of metal, such as stainless steel, and are placed a controlled distance apart to allow a reproducible arc for a given voltage and current. The electrical arcs between electrodes 22 and 24 in the fluid are used to generate shock waves in the fluid. The variable high voltage pulse generator 30 is used to deliver a stream of pulses to the electrodes 22 and 24 to create a stream of shock waves within the balloon 26 and within the artery being treated (not shown). The magnitude of the shock waves can be controlled by controlling the magnitude of the pulsed voltage, the current, the duration and repetition rate. The insulating nature of the balloon 26 protects the patient from electrical shocks.


The balloon 26 may be filled with water or saline in order to gently fix the balloon in the walls of the artery in the direct proximity with the calcified lesion. The fluid may also contain an x-ray contrast to permit fluoroscopic viewing of the catheter during use. The carrier 21 includes a lumen 29 through which a guidewire (not shown) may be inserted to guide the catheter into position. Once positioned the physician or operator can start with low energy shock waves and increase the energy as needed to crack the calcified plaque. Such Shockwaves will be conducted through the fluid, through the balloon, through the blood and vessel wall to the calcified lesion where the energy will break the hardened plaque without the application of excessive pressure by the balloon on the walls of the artery.



FIG. 3 is a schematic of the high voltage pulse generator 30. FIG. 3A shows a resulting waveform. The voltage needed will depend on the gap between the electrodes and generally 100 to 3000 volts. The high voltage switch 32 can be set to control the duration of the pulse. The pulse duration will depend on the surface area of the electrodes 22 and 24 and needs to be sufficient to generate a gas bubble at the surface of the electrode causing a plasma arc of electric current to jump the bubble and create a rapidly expanding and collapsing bubble, which creates the mechanical shock wave in the balloon. Such shock waves can be as short as a few microseconds.



FIG. 4 is a cross sectional view of the shockwave catheter 20 showing an arc 25 between the electrodes 22 and 24 and simulations of the shock wave flow 28. The shock wave 28 will radiate out from the electrodes 22 and 24 in all directions and will travel through the balloon 26 to the vessel where it will break the calcified lesion into smaller pieces.



FIG. 5 shows another dilating catheter 40. It has insulated electrodes 42 and 44 within the balloon 46 displaced along the length of the balloon 46.



FIG. 6 shows a dilating catheter 50 with an insulated electrode 52 within the balloon 56. The electrode is a single electrode pole in the balloon, a second pole being the ionic fluid 54 inside the balloon. This unipolar configuration uses the ionic fluid as the other electrical pole and permits a smaller balloon and catheter design for low profile balloons. The ionic fluid is connected electrically to the HV pulse generator 30.



FIG. 7 is another dilating 60 catheter with electrodes 62 and 64 within the balloon 66 and studs 65 to reach the calcification. The studs 65 form mechanical stress risers on the balloon surface 67 and are designed to mechanically conduct the shock wave through the intimal layer of tissue of the vessel and deliver it directly to the calcified lesion.



FIG. 8 is another dilating catheter 70 with electrodes 72 and 74 within the balloon 76 and with raised ribs 75 on the surface 77 of the balloon 76. The raised ribs 75 (best seen in FIG. 8A) form stress risers that will focus the shockwave energy to linear regions of the calcified plaque.



FIG. 9 is a further dilating catheter 80 with electrodes 82 and 84 within the balloon 86. The catheter 80 further includes a sensor 85 to detect reflected signals. Reflected signals from the calcified plaque can be processed by a processor 88 to determine quality of the calcification and quality of pulverization of the lesion.



FIG. 10 is a pressure volume curve of a prior art balloon breaking a calcified lesion. FIG. 10B shows the build up of energy within the balloon (region A to B) and FIG. 10C shows the release of the energy (region B to C) when the calcification breaks. At region C the artery is expanded to the maximum dimension of the balloon. Such a dimension can lead to injury to the vessel walls. FIG. 10A shows the initial inflation of the balloon.



FIG. 11 is a pressure volume curve showing the various stages in the breaking of a calcified lesion with shock waves according to the embodiment. The balloon is expanded with a saline fluid and can be expanded to fit snugly to the vessel wall (Region A) (FIG. 11A) hut this is not a requirement. As the High Voltage pulses generate shock waves (Region B and C) extremely high pressures, extremely short in duration will chip away the calcified lesion slowly and controllably expanding the opening in the vessel to allow blood to flow un-obstructed (FIG. 11B).



FIG. 12 shows, in a cutaway view, shock waves 98 delivered in all directions through the wall 92 of a saline filled balloon 90 and intima 94 to a calcified lesion 96. The shook waves 98 pulverize the lesion 96. The balloon wall 92 may be formed of non-compliant or compliant material to contact the intima 94.



FIG. 13 shows calcified plaque 96 pulverized by the shock waves. The intima 94 is smoothed and restored after the expanded balloon (not shown) has pulverized and reshaped the plaque into the vessel wall.



FIG. 14 is a schematic of a circuit 100 that uses the generator circuit 30 of FIG. 3 and a surface EKG 102 to synchronize the shook wave to the “R” wave for treating vessels near the heart. The circuit 200 includes an R-wave detector 205 and a controller 104 to control the high voltage switch 32. Mechanical shocks can stimulate heart muscle and could lead to an arrhythmia. While it is unlikely that shockwaves of such short duration as contemplated herein would stimulate the heart, by synchronizing the pulses (or bursts of pulses) with the R-wave, an additional degree of safety is provided when used on vessels of the heart or near the heart. While the balloon in the current drawings will provide an electrical isolation of the patient from the current, a device could be made in a non-balloon or non-isolated, manner using blood as the fluid. In such a device, synchronization to the R-wave would significantly improve the safety against unwanted arrhythmias.



FIG. 15 shows a still further dilation catheter 110 wherein a shock wave is focused with a parabolic reflector 114 acting as one electrode inside a fluid filled compliant balloon 116. The other electrode 112 is located at the coaxial center of the reflector 114. By using the reflector as one electrode, the shock wave can, be focused and therefore pointed at an angle (45 degrees, for example) off the center line 111 of the catheter artery. In this configuration, the other electrode 112 will be designed to be at the coaxial center of the reflector and designed to arc to the reflector 114 through the fluid. The catheter can be rotated if needed to break hard plaque as it rotates and delivers shockwaves.


While particular embodiments of the present invention have been shown and described, modifications may be made. For example, instead of manual actuation and spring loaded return of the valves used herein, constructions are possible which perform in a reversed manner by being spring actuated and manually returned. It is therefore intended, in the appended claims to cover ail such changes and modifications which fall within the true spirit and scope of the invention as defined by those claims.

Claims
  • 1. An angioplasty catheter comprising: an elongated carrier sized to fit within a blood vessel, said carrier having a guide wire lumen extending therethrough;an angioplasty balloon located near a distal end of the carrier with a distal end of the balloon being sealed to the carrier in a manner so a distal end of the guide wire lumen is positioned distally of the distal end of the balloon, and with the balloon being arranged to receive a fluid therein that inflates the balloon; andan arc generator including a pair of electrodes, said electrodes being positioned within and in non-touching relation to the balloon, said arc generator generating a high voltage pulse sufficient to create a plasma arc within the fluid resulting in a mechanical shock wave within the balloon that is conducted through the fluid and through the balloon and wherein the balloon is arranged to remain intact during the formation of the shock wave.
  • 2. A catheter as recited in claim 1 wherein a central portion of the balloon is radially symmetric about a center line and wherein the electrodes are located between the inner surface of the balloon and the center line of the balloon.
  • 3. A catheter as recited in claim 1 wherein one electrode in the pair is larger than the other electrode in the pair.
  • 4. An angioplasty catheter comprising: an elongated carrier sized to fit within a blood vessel, said carrier having a guide wire lumen extending therethrough; an angioplasty balloon located near a distal end of the carrier with a distal end of the balloon being sealed to the carrier and with the balloon being arranged to receive a fluid therein that inflates the balloon;a high voltage generator for generating high voltage pulses; anda first electrode connected to the high voltage generator, said first electrode being positioned within and in non-touching relation to the balloon, and with the fluid within the balloon being coupled to the high voltage generator via a second electrode positioned outside the balloon and within a channel coupled to the balloon, said fluid in the balloon functioning as an electrical pole, said high voltage generator generating a high voltage pulse sufficient to create a plasma arc within the fluid resulting in a mechanical shock wave within the balloon that is conducted through the fluid and through the balloon and wherein the balloon is arranged to remain intact during the formation of the shock wave.
  • 5. A system comprising: an angioplasty catheter including an elongated carrier sized to fit within a blood vessel, said carrier having a guide wire lumen extending therethrough, an angioplasty balloon located near a distal end of the carrier with a distal end of the balloon being sealed to the carrier near the distal end of the carrier in a manner so a distal end of the guide wire lumen is positioned distally of the distal end of the balloon, said balloon being arranged to receive a fluid therein that inflates the balloon, and an arc generator including a pair of electrodes being positioned within and in non-touching relation to the balloon; anda power source configured to provide a high voltage pulse to the arc generator, said high voltage pulse sufficient to create a plasma arc resulting in a mechanical shock wave within the balloon that is conducted through the fluid and through the balloon and wherein the balloon is arranged to remain intact during the formation of the shock wave.
  • 6. A catheter as recited in claim 5 wherein a central portion of the balloon is radially symmetric about a center line and wherein the electrodes are located between the inner surface of the balloon and the center line of the balloon.
  • 7. A catheter as recited in claim 5 wherein one electrode in the pair is larger than the other electrode in the pair.
  • 8. An angioplasty catheter comprising: an elongated carrier, the carrier defining a guide wire sheath having a guide wire lumen;a balloon about the carrier in sealed relation thereto, the balloon having an inner wall and an outer wall, being arranged to receive a fluid therein that inflates the balloon, and having a symmetrical configuration with a center line and a central portion with a constant diameter, the guide wire sheath being centered along the center line of the balloon; anda shock wave generator including a pair of electrodes within the balloon wherein both of said electrodes are located external to the guide wire sheath and are radially offset from the center line of the balloon, said shock wave generator forming a mechanical shock wave within the balloon that is conducted through the fluid and through the balloon and wherein the balloon is arranged to remain intact during the formation of the shock wave.
  • 9. A catheter as recited in claim 8 wherein one electrode in the pair is larger than the other electrode in the pair.
  • 10. A catheter as recited in claim 8 wherein one of the electrodes is laterally displaced along the length of the balloon with respect to the other electrode.
PRIORITY CLAIM

The present application is a continuation of U.S. patent application Ser. No. 13/646,570, filed Oct. 5, 2012, which is a continuation of U.S. patent application Ser. No. 12/482,995, filed Jun. 11, 2009, now issued as U.S. Pat. No. 8,956,371 on Feb. 17, 2015, which claims the benefit of U.S. Provisional Patent Application Ser. No. 61/061,170, filed Jun. 13, 2008, each of which is incorporated herein by reference in its entirety.

US Referenced Citations (166)
Number Name Date Kind
3413976 Roze Dec 1968 A
3785382 Schmidt et al. Jan 1974 A
3902499 Shene Sep 1975 A
4027674 Tessler et al. Jun 1977 A
4030505 Tessler Jun 1977 A
4662126 Malcolm May 1987 A
4671254 Fair Jun 1987 A
4685458 Leckrone Aug 1987 A
4809682 Forssmann et al. Mar 1989 A
4813934 Engelson Mar 1989 A
4878495 Grayzel Nov 1989 A
4900303 Lemelson Feb 1990 A
4994032 Sugiyama Feb 1991 A
5009232 Hassler et al. Apr 1991 A
5046503 Schneiderman Sep 1991 A
5057103 Davis Oct 1991 A
5057106 Kasevich et al. Oct 1991 A
5061240 Cherian Oct 1991 A
5078717 Parins et al. Jan 1992 A
5103804 Abele et al. Apr 1992 A
5152767 Sypal et al. Oct 1992 A
5152768 Bhatta Oct 1992 A
5154722 Filip et al. Oct 1992 A
5176675 Watson et al. Jan 1993 A
5195508 Muller et al. Mar 1993 A
5245988 Einars et al. Sep 1993 A
5246447 Rosen et al. Sep 1993 A
5281231 Rosen et al. Jan 1994 A
5295958 Shturman Mar 1994 A
5321715 Trost Jun 1994 A
5324255 Passafaro et al. Jun 1994 A
5336234 Vigil et al. Aug 1994 A
5362309 Carter Nov 1994 A
5364393 Auth et al. Nov 1994 A
5368591 Lennox et al. Nov 1994 A
5395335 Jang Mar 1995 A
5417208 Winkler May 1995 A
5425735 Rosen et al. Jun 1995 A
5472406 De et al. Dec 1995 A
5582578 Zhong et al. Dec 1996 A
5603731 Whitney Feb 1997 A
5609606 O'Boyle Mar 1997 A
5662590 De et al. Sep 1997 A
5846218 Brisken et al. Dec 1998 A
5931805 Brisken Aug 1999 A
6007530 Doernhoefer et al. Dec 1999 A
6033371 Torre et al. Mar 2000 A
6080119 Schwarze et al. Jun 2000 A
6083232 Cox Jul 2000 A
6113560 Simnacher Sep 2000 A
6186963 Schwarze et al. Feb 2001 B1
6210408 Chandrasekaran Apr 2001 B1
6217531 Reitmajer Apr 2001 B1
6267747 Samson et al. Jul 2001 B1
6277138 Levinson et al. Aug 2001 B1
6287272 Brisken et al. Sep 2001 B1
6352535 Lewis et al. Mar 2002 B1
6367203 Graham et al. Apr 2002 B1
6371971 Tsugita et al. Apr 2002 B1
6398792 O'Connor Jun 2002 B1
6406486 De La Torre et al. Jun 2002 B1
6514203 Bukshpan Feb 2003 B2
6524251 Rabiner et al. Feb 2003 B2
6589253 Cornish et al. Jul 2003 B1
6607003 Wilson Aug 2003 B1
6638246 Naimark et al. Oct 2003 B1
6652547 Rabiner et al. Nov 2003 B2
6689089 Tiedtke et al. Feb 2004 B1
6736784 Menne et al. May 2004 B1
6740081 Hilal May 2004 B2
6755821 Fry Jun 2004 B1
6989009 Lafontaine Jan 2006 B2
7241295 Maguire Jul 2007 B2
7505812 Eggers et al. Mar 2009 B1
7569032 Naimark et al. Aug 2009 B2
7873404 Patton Jan 2011 B1
7951111 Drasler et al. May 2011 B2
8162859 Schultheiss et al. Apr 2012 B2
8556813 Cioanta et al. Oct 2013 B2
8574247 Adams et al. Nov 2013 B2
8728091 Hakala et al. May 2014 B2
8747416 Hakala et al. Jun 2014 B2
8888788 Hakala et al. Nov 2014 B2
8956371 Hawkins Feb 2015 B2
8956374 Hawkins Feb 2015 B2
9005216 Hakala et al. Apr 2015 B2
9011462 Adams Apr 2015 B2
9011463 Adams Apr 2015 B2
9044618 Hawkins et al. Jun 2015 B2
9044619 Hawkins et al. Jun 2015 B2
9333000 Hakala et al. May 2016 B2
9421025 Hawkins et al. Aug 2016 B2
20010044596 Jaafar Nov 2001 A1
20020045890 Celliers et al. Apr 2002 A1
20020177889 Brisken et al. Nov 2002 A1
20030004434 Greco et al. Jan 2003 A1
20030176873 Chernenko et al. Sep 2003 A1
20030229370 Miller Dec 2003 A1
20040044308 Naimark et al. Mar 2004 A1
20040097963 Seddon et al. May 2004 A1
20040097996 Rabiner et al. May 2004 A1
20040162508 Uebelacker et al. Aug 2004 A1
20040254570 Hadjicostis et al. Dec 2004 A1
20050015953 Keidar Jan 2005 A1
20050021013 Visuri et al. Jan 2005 A1
20050059965 Eberl et al. Mar 2005 A1
20050075662 Pedersen et al. Apr 2005 A1
20050090888 Hines Apr 2005 A1
20050113722 Schultheiss et al. May 2005 A1
20050113822 Fuimaono et al. May 2005 A1
20050171527 Bhola Aug 2005 A1
20050228372 Truckai et al. Oct 2005 A1
20050245866 Azizi Nov 2005 A1
20050251131 Lesh Nov 2005 A1
20060004286 Chang et al. Jan 2006 A1
20060074484 Huber Apr 2006 A1
20060184076 Gill et al. Aug 2006 A1
20060190022 Beyar et al. Aug 2006 A1
20070016112 Schultheiss et al. Jan 2007 A1
20070088380 Hirszowicz et al. Apr 2007 A1
20070129667 Tiedtke et al. Jun 2007 A1
20070239082 Schultheiss et al. Oct 2007 A1
20070239253 Jagger et al. Oct 2007 A1
20070244423 Zumeris et al. Oct 2007 A1
20072055270 Carney Nov 2007
20070282301 Segalescu et al. Dec 2007 A1
20070299481 Syed et al. Dec 2007 A1
20080097251 Babaev Apr 2008 A1
20080188913 Stone et al. Aug 2008 A1
20090041833 Bettinger et al. Feb 2009 A1
20090247945 Levit et al. Oct 2009 A1
20090254114 Hirszowicz et al. Oct 2009 A1
20090312768 Hawkins et al. Dec 2009 A1
20100016862 Hawkins et al. Jan 2010 A1
20100036294 Mantell Feb 2010 A1
20100094209 Drasler et al. Apr 2010 A1
20100114020 Hawkins et al. May 2010 A1
20100114065 Hawkins et al. May 2010 A1
20100121322 Swanson May 2010 A1
20100305565 Truckai et al. Dec 2010 A1
20110034832 Cioanta et al. Feb 2011 A1
20110118634 Golan May 2011 A1
20110166570 Hawkins et al. Jul 2011 A1
20110208185 Diamant et al. Aug 2011 A1
20110295227 Hawkins et al. Dec 2011 A1
20120071889 Mantell et al. Mar 2012 A1
20120095461 Herscher et al. Apr 2012 A1
20120203255 Hawkins et al. Aug 2012 A1
20120221013 Hawkins et al. Aug 2012 A1
20130030431 Adams Jan 2013 A1
20130030447 Adams Jan 2013 A1
20140005576 Adams et al. Jan 2014 A1
20140039513 Hakala et al. Feb 2014 A1
20140052145 Adams et al. Feb 2014 A1
20140052147 Hakala et al. Feb 2014 A1
20140074111 Hakala et al. Mar 2014 A1
20140074113 Hakala et al. Mar 2014 A1
20140243820 Adams et al. Aug 2014 A1
20140243847 Hakala et al. Aug 2014 A1
20140288570 Adams Sep 2014 A1
20150073430 Adams et al. Mar 2015 A1
20150238209 Hawkins et al. Aug 2015 A1
20150320432 Adams Nov 2015 A1
20160151081 Adams et al. Jun 2016 A1
20160183957 Hakala et al. Jun 2016 A1
20160324534 Hawkins et al. Nov 2016 A1
Foreign Referenced Citations (54)
Number Date Country
2009313507 Nov 2014 AU
1269708 Oct 2000 CN
101043914 Sep 2007 CN
102057422 May 2011 CN
102271748 Dec 2011 CN
102765785 Nov 2012 CN
3038445 May 1982 DE
442199 Aug 1991 EP
571306 Nov 1993 EP
0623360 Nov 1994 EP
2253884 Nov 2010 EP
2362798 Apr 2014 EP
60-191353 Dec 1985 JP
62-99210 Jun 1987 JP
62-275446 Nov 1987 JP
3-63059 Mar 1991 JP
6-125915 May 1994 JP
7-47135 Feb 1995 JP
8-89511 Apr 1996 JP
10-99444 Apr 1998 JP
10-314177 Dec 1998 JP
10-513379 Dec 1998 JP
2002-538932 Nov 2002 JP
2004-081374 Mar 2004 JP
2004-357792 Dec 2004 JP
2005-095410 Apr 2005 JP
2005-515825 Jun 2005 JP
2006-516465 Jul 2006 JP
2007-532182 Nov 2007 JP
2008-506447 Mar 2008 JP
2011-513694 Apr 2011 JP
2011-520248 Jul 2011 JP
2011-524203 Sep 2011 JP
2011-528963 Dec 2011 JP
2012-505050 Mar 2012 JP
2012-508042 Apr 2012 JP
6029828 Nov 2016 JP
6081510 Feb 2017 JP
1996024297 Aug 1996 WO
199902096 Jan 1999 WO
2004069072 Aug 2004 WO
2005099594 Oct 2005 WO
2006006169 Jan 2006 WO
2006127158 Nov 2006 WO
2007088546 Aug 2007 WO
2007149905 Dec 2007 WO
2009121017 Oct 2009 WO
2009126544 Oct 2009 WO
2009152352 Dec 2009 WO
2010014515 Feb 2010 WO
2010014515 Aug 2010 WO
2010054048 Sep 2010 WO
2011143468 Nov 2011 WO
2012025833 Mar 2012 WO
Non-Patent Literature Citations (141)
Entry
Japanese Patent Application Publication S62-275446 to Uchiyama, published Nov. 30, 1987.
Notice of Allowance received for U.S. Appl. No. 12/581,295, dated Jul. 10, 2015, 15 pages.
Notice of Allowance received for U.S. Appl. No. 12/581,295, dated Jul. 29, 2015, 7 pages.
Notice of Allowance received for U.S. Appl. No. 13/049,199, dated Jan. 13, 2015, 4 pages.
Final Office Action received for U.S. Appl. No. 13/615,107 dated Sep. 1, 2015, 9 pages.
Notice of Allowance received for U.S. Appl. No. 13/957,276, dated Aug. 28, 2015, 9 pages.
Final Office Action received for U.S. Appl. No. 14/229,735, dated Aug. 27, 2015, 7 pages.
Office Action received for Canadian Patent Application No. 2,727,429, dated May 26, 2015, 1 page.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2015/029088 dated Jul. 16, 2015, 13 pages.
International Written Opinion received for PCT Patent Application No. PCT/US2012/023172, dated Sep. 28, 2012, 4 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2013/031805, dated Feb. 19, 2015, 11 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2013/039987, dated Nov. 20, 2014, 11 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2013/048277, dated Jan. 8, 2015, 9 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2013/055431, dated Feb. 26, 2015, 7 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2013/059533, dated Mar. 26, 2015, 10 pages.
Office Action received for Canadian Patent Application No. 2,727,429, dated Apr. 14, 2015, 4 pages.
Decision to Grant received for Japanese Patent Application No. 2011-513694, dated Oct. 7, 2014, 3 pages of official copy only. (See Communication under 37 CFR § 1.98(a) (3)).
Advisory Action Received for U.S. Appl. No. 13/049,199, dated Jun. 7, 2012, 3 pages.
Notice of Allowance received for U.S. Appl. No. 13/049,199, dated Dec. 15, 2014, 7 pages.
Non-Final Office Action received for U.S. Appl. No. 12/581,295, dated Jan. 15, 2015, 14 pages.
Non-Final Office Action received for U.S. Appl. No. 13/267,383, dated Feb. 25, 2015, 9 pages.
Non-Final Office Action received for U.S. Appl. No. 13/465,264, dated Dec. 23, 2014, 13 pages.
Notice of Allowance received for U.S. Appl. No. 13/465,264, dated May 8, 2015, 7 pages.
Non-Final Office Action received for U.S. Appl. No. 13/615,107, dated Apr. 24, 2015, 9 pages.
Notice of Allowance received for U.S. Appl. No. 14/271,276, dated Feb. 25, 2015, 8 pages.
Final Office Action received for U.S. Appl. No. 14/271,342 dated Feb. 27, 2015, 7 pages.
Notice of Allowance received for U.S. Appl. No. 14/271,342, dated Mar. 13, 2015, 5 pages.
Final Office Action Received for U.S. Appl. No. 13/267,383, dated May 28, 2015, 12 pages.
Notice of Allowance received for U.S. Appl. No. 13/777,807, dated May 19, 2015, 13 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2009/047070, dated Dec. 23, 2010, 7 pages.
International Search Report received for PCT Patent Application No. PCT/US2009/047070, dated Jan. 19, 2010, 4 pages.
Written Opinion received for PCT Patent Application No. PCT/US2009/047070, dated Jan. 19, 2010, 5 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2011/047070, dated Feb. 21, 2013, 7 pages.
International Written Opinion received for PCT Patent Application No. PCT/US2011/047070, dated May 1, 2012, 5 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2012/023172, dated Aug. 15, 2013, 6 pages.
International Search Report received for PCT Patent Application No. PCT/US2012/023172, dated Sep. 28, 2012, 3 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2013/031805 dated May 20, 2013, 13 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2013/039987, dated Sep. 23, 2013, 15 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2013/048277, dated Oct. 2, 2013, 14 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2013/055431, dated Nov. 12, 2013, 9 pages.
International Search Report and Written Opinion received for PCT Patent Application No. PCT/US2013/059533, dated Nov. 7, 2013, 14 pages.
Extended European Search Report (includes Supplementary European Search Report and Search Opinion) received for European Patent Application No. 097636401, dated Oct. 10, 2013, 5 pages.
Notice of Acceptance Received for Australian Patent Application No. 2009257368, dated Aug. 28, 2014, 2 pages.
Office Action received for Australian Patent Application No. 2009257368, dated Apr. 28, 2014, 4 pages.
Office Action received for Australian Patent Application No. 2009257368, dated Jul. 31, 2013, 4 pages.
Office Action received for Japanese Patent Application No. 2011-513694, dated Aug. 27, 2013, 6 pages.
Office Action Received for Japanese Patent Application No. 2011-513694, dated Jun. 10, 2014, 2 pages.
Advisory Action Received for U.S. Appl. No. 12/482,995, dated Jun. 2, 2014, 3 pages.
Advisory Action Received for U.S. Appl. No. 12/482,995, dated Sep. 29, 2011, 2 pages.
Final Office Action received for U.S. Appl. No. 12/482,995, dated Feb. 20, 2014, 11 pages.
Non Final Office Action received for U. S. Appl. No. 12/482,995, dated Aug. 13, 2014, 10 pages.
Non Final Office Action received for U.S. Appl. No. 12/482,995, dated Jul. 12, 2013, 11 pages.
Notice of Allowance received for U.S. Appl. No. 12/482,995, dated Dec. 24, 2014, 6 pages.
Non-Final Office Action received for U.S. Appl. No. 12/501,619, dated Jan. 28, 2014, 10 pages.
Advisory Action Received for U.S. Appl. No. 12/581,295, dated Jul. 3, 2014, 3 pages.
Final Office Action received for U.S. Appl. No. 12/581,295, dated Jun. 5, 2014, 14 pages.
Non-Final Office Action received for U.S. Appl. No. 12/581,295, dated Mar. 10, 2014, 11 pages.
Final Office Action received for U.S. Appl. No. 13/049,199 dated Aug. 11, 2014, 8 pages.
Non-Final Office Action received for U.S. Appl. No. 13/049,199, dated Feb. 4, 2014, 8 pages.
Advisory Action received for U.S. Appl. No. 13/267,383, dated Jan. 6, 2014, 4 pages.
Final Office Action received for U.S. Appl. No. 13/267,383, dated Oct. 25, 2013, 8 pages.
Non Final Office Action received for U.S. Appl. No. 13/465,264, dated Oct. 29, 2014, 13 pages.
Final Office Action received for U.S. Appl. No. 13/646,570, dated Dec. 23, 2014, 10 pages.
Non Final Office Action received for U.S. Appl. No. 13/646,570, dated Oct. 29, 2014, 10 pages.
Notice of Allowance received for U.S. Appl. No. 13/646,570, dated Mar. 11, 2015, 7 pages.
Non-Final Office Action received for U.S. Appl. No. 13/646,583, dated Oct. 31, 2014, 8 pages.
Notice of Allowance received for U.S. Appl. No. 13/831,543, dated Oct. 8, 2014, 14 pages.
Non-Final Office Action received for U.S. Appl. No. 14/061,554, dated Mar. 12, 2014, 14 pages.
Notice of Allowance received for U.S. Appl. No. 14/061,554, dated Apr. 25, 2014, 8 pages.
Non Final Office Action received for U.S. Appl. No. 14/079,463, dated Mar. 4, 2014, 9 pages.
Notice of Allowance received for U.S. Appl. No. 14/079,463, dated Apr. 1, 2014, 5 pages.
Non-Final Office Action received for U.S. Appl. No. 14/271,276, dated Aug. 4, 2014, 7 pages.
Non-Final Office Action received for U.S. Appl. No. 14/271,342, dated Sep. 2, 2014, 6 pages.
Rosenschein et al., “Shock-Wave Thrombus Ablation, a New Method for Noninvasive Mechanical Thrombolysis”, The American Journal of Cardiology, vol. 70, Nov. 15, 1992, pp. 1358-1361.
Zhong et al., “Transient Oscillation of Cavitation Bubbles Near Stone Surface During Electohydraulic Lithotripsy”, Journal of Endourology, vol. 11, No. 1, Feb. 1997, pp. 55-61.
Office Action Received for Japanese Patent Application No. 2014-158517, dated May 19, 2015, 3 pages of Official Copy Only (see communication under 37 CFR § 1.98(a) (3)).
Advisory Action received for U.S. Appl. No. 13/615,107, dated Nov. 6, 2015, 3 pages.
Extended European Search Report received for European Patent Application No. 13827971.6, dated Apr. 12, 2016, 8 pages.
Non Final Office Action received for U.S. Appl. No. 13/534,658, dated Mar. 11, 2016, 12 pages.
Non Final Office Action received for U.S. Appl. No. 14/218,858, dated Mar. 30, 2016, 13 pages.
Non Final Office Action received for U.S. Appl. No. 14/515,130, dated Jan. 14, 2016, 16 pages.
Non-Final Office Action received for U.S. Appl. No. 14/273,063, dated Jun. 3, 2016, 9 pages.
Notice of Allowance received for U.S. Appl. No. 14/515,130, dated May 2, 2016, 8 pages.
Notice of Allowance received for U.S. Appl. No. 14/515,130, dated May 25, 2016, 3 pages.
Notice of Allowance received for U.S. Appl. No. 13/615,107, dated Dec. 31, 2015, 10 pages.
Decision to Grant received for European Patent Application No. 13756766.5, dated May 27, 2016, 2 pages.
Final Office Action received for U.S. Appl. No. 13/534,658, dated Aug. 23, 2016, 11 pages.
Hakala Doug, U.S. Appl. No. 15/220,999, filed Jul. 27, 2016, titled “Low Profile Electrode for an Angioplasty Shock Wave Catheter”.
Intention to Grant received for European Patent Application No. 13756766.5, dated Jan. 8, 2016, 5 pages.
Notice of Allowance received for U.S. Appl. No. 14/218,858, dated Aug. 26, 2016, 8 pages.
Office Action received for Chinese Patent Application No. 201380033808.3, dated Jul. 5, 2016, 9 pages (3 pages of English Translation and 6 pages of Official Copy).
Office Action received for Chinese Patent Application No. 201380041656.1, dated Jul. 5, 2016, 9 pages (4 pages of English Translation and 6 pages of Official Copy).
Office Action received for Chinese Patent Application No. 201380042887.4, dated Aug. 8, 2016, 9 pages (4 pages of English Translation 5 pages of Official Copy).
Notice of Allowance received for Japanese Patent Application No. 2015-036444, dated Jan. 13, 2017, 3 pages (Official Copy Only) (See Communication under 37 CFR § 1.98(a) (3)).
Office Action received for Canadian Patent Application No. 2,779,600, dated Oct. 19, 2016, 3 pages.
Office Action received for European Patent Application No. 09763640.1, dated Dec. 2, 2016, 4 pages.
Office Action received for Japanese Patent Application No. 2014-158517, dated Feb. 15, 2017, 8 pages (5 pages of English Translation and 3 pages of Official Copy Only).
Office Action received for Japanese Patent Application No. 2016-094326, dated Dec. 2, 2016, 4 pages (2 pages of English Translation and 2 pages Official Copy Only).
Decision to Grant received for European Patent Application No. 09825393.3, dated Mar. 13, 2014, 2 pages.
Extended European Search Report and Search Opinion received for European Patent Application No. 09825393.3, dated Feb. 28, 2013, 6 pages.
Final Office Action received for U.S. Appl. No. 12/482,995, dated Jul. 22, 2011, 14 pages.
Final Office Action received for U.S. Appl. No. 12/611,997, dated Dec. 11, 2012, 9 pages.
Final Office Action received for U.S. Appl. No. 12/611,997, dated Nov. 10, 2011, 15 pages.
Final Office Action received for U.S. Appl. No. 13/049,199, dated Apr. 4, 2012, 10 pages.
Final Office Action received for U.S. Appl. No. 13/207,381, dated Nov. 2, 2012, 7 pages.
Final Office Action received for U.S. Appl. No. 12/611,997, dated Oct. 24, 2013, 10 pages.
Final Office Action received for U.S. Appl. No. 13/207,381, dated Nov. 7, 2013, 7 pages.
International Preliminary Report on Patentability received for PCT Patent Application No. PCT/US2009/063354, dated May 19, 2011, 6 pages.
International Search Report received for PCT Patent Application No. PCT/US2009/063354, dated Jun. 11, 2010, 3 pages.
International Written Opinion received for PCT Patent Application No. PCT/US2009/063354, dated Jun. 11, 2010, 4 pages.
Non Final Office Action received for U.S. Appl. No. 12/611,997, dated Nov. 26, 2014, 8 pages.
Non Final Office Action received for U.S. Appl. No. 13/207,381, dated Nov. 25, 2014, 5 pages.
Non Final Office Action received for U.S. Appl. No. 12/482,995, dated Feb. 11, 2011, 27 pages.
Non Final Office Action received for U.S. Appl. No. 12/611,997, dated Apr. 8, 2013, 9 pages.
Non Final Office Action received for U.S. Appl. No. 12/611,997, dated Aug. 24, 2012, 11 pages.
Non Final Office Action received for U.S. Appl. No. 12/611,997, dated Jun. 21, 2011, 13 pages.
Non Final Office Action received for U.S. Appl. No. 13/049,199, dated Dec. 12, 2011, 10 pages.
Non Final Office Action received for U.S. Appl. No. 13/207,381, dated Feb. 22, 2013, 7 pages.
Non Final Office Action received for U.S. Appl. No. 13/207,381, dated Jun. 12, 2012, 6 pages.
Non Final Office Action received for U.S. Appl. No. 12/611,997, dated Feb. 13, 2014, 9 pages.
Non Final Office Action received for U.S. Appl. No. 13/207,381, dated Feb. 25, 2014, 8 pages.
Non Final Office Action received for U.S. Appl. No. 14/693,155, dated Jan. 15, 2016, 6 pages.
Notice of Acceptance received for Australian Patent Application No. 2009313507, dated Nov. 17, 2014, 2 pages.
Notice of Allowance received for Canadian Patent Application No. 2,779,600, dated Jul. 7, 2017, 1 page.
Notice of Allowance received for U.S. Appl. No. 12/611,997, dated Apr. 15, 2015, 7 pages.
Notice of Allowance received for U.S. Appl. No. 13/207,381, dated Apr. 14, 2015, 7 pages.
Notice of Allowance received for U.S. Appl. No. 14/693,155, dated Apr. 26, 2016, 9 pages.
Office Action received for Australian Patent Application No. 2009313507, dated Nov. 13, 2013, 3 pages.
Office Action received for Canadian Patent Application No. 2,779,600, dated Jan. 4, 2016, 6 pages.
Office Action received for Chinese Patent Application No. 200980153687.X, dated Dec. 26, 2012, 11 pages (Official Copy Only) (See Communication under 37 CFR § 1.98(a) (3)).
Office Action received for Chinese Patent Application No. 200980153687.X, dated Jul. 11, 2013, 11 pages (Official Copy Only) (See Communication under 37 CFR § 1.98(a) (3)).
Office Action Received for Japanese Patent Application No. 2011-534914, dated Jan. 13, 2015, 9 pages (7 pages of English Translation and 2 pages of Official Copy).
Office Action Received for Japanese Patent Application No. 2011-534914, dated Jul. 15, 2014, 3 pages (1 page of English Translation and 2 pages of Official Copy).
Decision of Appeals Notice received for Japanese Patent Application No. 2011-534914, dated Oct. 17, 2016, 2 pages (Official Copy Only) (See Communication under 37 CFR § 1.98(a) (3)).
Office Action received for Japanese Patent Application No. 2011-534914, dated May 10, 2016, 10 pages (6 pages of English Translation and 4 pages of Official Copy).
Office Action received for Japanese Patent Application No. 2011-534914, dated Oct. 1, 2013, 5 pages (2 pages of English Translation and 3 pages of Official Copy).
Office Action received for Japanese Patent Application No. 2014-158517, dated Jun. 22, 2017, 14 pages (Official Copy Only) (See Communication under 37 CFR § 1.98(a) (3)).
Office Action received for Japanese Patent Application No. 2015-036444, dated Feb. 23, 2016, 3 pages (English Translation Only).
Office Action received for Japanese Patent Application No. 2016-143049, dated Apr. 24, 2017, 5 pages (3 pages of English Translation and 2 pages of Official Copy).
Office Action received for Japanese Patent Application No. 2015-036444, dated Sep. 14, 2016, 5 pages (3 Pages of English Translation and 2 pages of Official Copy).
Office Action received for Japanese Patent Application No. 2016-094326, dated Jul. 6, 2017, 2 pages (Official Copy Only) (See Communication under 37 CFR § 1.98(a) (3)).
Related Publications (1)
Number Date Country
20150238208 A1 Aug 2015 US
Provisional Applications (1)
Number Date Country
61061170 Jun 2008 US
Continuations (2)
Number Date Country
Parent 13646570 Oct 2012 US
Child 14660539 US
Parent 12482995 Jun 2009 US
Child 13646570 US