Source: https://patents.google.com/patent/US10039561B2/en
Timestamp: 2019-04-21 04:43:20+00:00

Document:
2015-05-13 Assigned to DJT, LLC reassignment DJT, LLC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HAWKINS, DANIEL, ADAMS, JOHN M., ALFERNESS, CLIFTON A.
2018-12-07 First worldwide family litigation filed litigation Critical https://patents.darts-ip.com/?family=41415460&utm_source=google_patent&utm_medium=platform_link&utm_campaign=public_patent_search&patent=US10039561(B2) "Global patent litigation dataset” by Darts-ip is licensed under a Creative Commons Attribution 4.0 International License.
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.
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.
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 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 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 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.
FIG. 13 shows calcified plague pulverized and smooth a endothelium restored by the expanded balloon after pulverization.
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.
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. 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.
an 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.
a 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.
a 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.
a 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.
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)).
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Hakala Doug, U.S. Appl. No. 15/220,999, filed Jul. 27, 2016, titled "Low Profile Electrode for an Angioplasty Shock Wave Catheter".
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References: Application No. 2011
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 Application No. 097636401
 Application No. 2
 Application No. 200980153687
 § 1
 Application No. 200980153687
 § 1
 Application No. 201380041656
 Application No. 201380042887
 Application No. 2011
 Application No. 2011
 Application No. 2011
 Application No. 2014
 § 1
 Application No. 2014
 § 1
 Application No. 2016
 Application No. 2016