Source: http://www.google.com/patents/US6056742?dq=U.S.+Patent+
Timestamp: 2017-04-23 09:01:26
Document Index: 775157666

Matched Legal Cases: ['art.\n3', 'art.\n4', 'art.\n16', 'art.\n19', 'art. 22', 'art. 23', 'art.\n31', 'art.\n32', 'Application No. 08', 'Application No. 08', 'art 98', 'art 98', 'application No. 4']

Patent US6056742 - Revascularization with laser outputs - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inPatentsApparatus for treating a patient's heart by stimulating revascularization of the heart or creating channels in the heart. The apparatus includes a catheter, a laser energy source coupled to the catheter, and a control circuit. The control circuit is configured to cause the laser energy source to deliver...http://www.google.com/patents/US6056742?utm_source=gb-gplus-sharePatent US6056742 - Revascularization with laser outputsAdvanced Patent SearchTry the new Google Patents, with machine-classified Google Scholar results, and Japanese and South Korean patents.Publication numberUS6056742 APublication typeGrantApplication numberUS 08/852,011Publication dateMay 2, 2000Filing dateMay 6, 1997Priority dateFeb 3, 1997Fee statusLapsedPublication number08852011, 852011, US 6056742 A, US 6056742A, US-A-6056742, US6056742 A, US6056742AInventorsDouglas R. Murphy-Chutorian, Richard L. Mueller, Michael J. RosinkoOriginal AssigneeEclipse Surgical Technologies, Inc.Export CitationBiBTeX, EndNote, RefManPatent Citations (41), Non-Patent Citations (94), Referenced by (65), Classifications (9), Legal Events (7) External Links: USPTO, USPTO Assignment, EspacenetRevascularization with laser outputs
US 6056742 AAbstract
Apparatus for treating a patient's heart by stimulating revascularization of the heart or creating channels in the heart. The apparatus includes a catheter, a laser energy source coupled to the catheter, and a control circuit. The control circuit is configured to cause the laser energy source to deliver an output of laser energy over a first time period shorter than a heart beat cycle.
1. An apparatus for treating a patient's heart, the apparatus comprising:a catheter; a laser energy source coupled to the catheter; a shutter positioned to block energy from the laser energy source when the shutter is closed; and a control circuit that is configured to close the shutter to block laser energy and to open the shutter to allow the laser energy source to deliver an output of energy to the patient's heart, wherein the control circuit is configured to deliver the output of laser energy over a first time period that is sufficiently short so that the output causes no more than one heartheat, and the laser energy source and catheter are adapted to cause heartbeats by the delivery of the laser energy. 2. The apparatus of claim 1, wherein the control circuit is configured to deliver the output of laser energy wherein the first time period is shorter than a second time period from a Q wave to a T wave of the heart.
3. The apparatus of claim 1, wherein the control circuit is configured to deliver a second output of laser energy after a second time period equal to or shorter than a third time period from a T wave to a Q wave of the heart.
4. The apparatus of claim 1, wherein the control circuit is configured to deliver outputs of laser energy at a rate equal to or faster than the patient's heart rate before revascularization.
5. The apparatus of claim 4, wherein the rate of outputs is 20 outputs per minute faster than the patient's heart rate before revascularization.
6. The apparatus of claim 1, wherein the control circuit is configured to deliver the output of laser energy wherein the output of laser energy comprises a set of pulses of laser energy.
7. The apparatus of claim 6, wherein the set of pulses comprises a number of laser pulses in the range 1 to 4.
8. The apparatus of claim 6, wherein the control circuit is configured to deliver laser pulses in the set of laser pulses at a rate greater than 15 laser pulses per second.
9. An apparatus for treating a patient's heart, the apparatus comprising:a catheter, a pacemaker; a laser energy source coupled to the catheter for delivering laser energy to the patient's heart; a shutter configured to block laser energy from the laser energy source; and a control circuit coupled to the pacemaker which is configured to cause the pacemaker to cause only one heartbeat per the output of laser energy and to control opening and closing of the shutter. 10. The apparatus of claim 9, wherein the control circuit is configured to deliver a pace signal to the heart before causing the laser energy source to deliver the output of laser energy.
11. The apparatus of claim 9, wherein the laser energy source comprises a CO2 laser.
12. The apparatus of claim 7, wherein the control circuit is configured to deliver between two and four pace signals to the heart before causing the laser energy source to deliver the output of laser energy.
13. The apparatus of claim 9, wherein the control circuit is configured to deliver a pace signal to the heart after causing the laser energy source to deliver the output of laser energy.
14. The apparatus of claim 3, wherein the control circuit is configured to deliver between two and four pace signals to the heart after causing the laser energy source to deliver the output of laser energy.
15. The apparatus of claim 13, wherein the control circuit is configured to deliver the output of laser energy over a first time period that is shorter than a second time period from a Q wave to a T wave of the heart and wherein the control circuit is configured to deliver a second output of laser energy after a third time period shorter than a fourth time period from a T wave to a Q wave of the heart.
16. The apparatus of claim 9, wherein the laser energy source comprises a medical laser having a wavelength in the range of 308 nanometers to 10.6 micrometers.
17. The apparatus of claim 9, wherein the laser energy source comprises a holmium laser.
18. The apparatus of claim 10, wherein the control circuit is configured to deliver the output of laser energy the first time period that is shorter than a second time period from a Q wave to a T wave of the heart and wherein the control circuit is configured to deliver a second output of laser energy after a third time period shorter than a fourth time period from a T wave to a Q wave of the heart.
19. The apparatus of claim 9, wherein the laser energy source comprises an excimer laser.
20. A method of treating a heart, the method comprising:providing a laser energy source; introducing a laser energy delivery device coupled to the laser energy source to the heart; using the laser energy delivery device to deliver energy source to the heart cause a revascularization event in the heart; and causing the laser energy delivery device to deliver from the laser energy source an output of laser energy sufficient to cause only one heartbeat per the output of laser energy. 21. The method of claim 20 comprising:delivering the output of laser energy for a first time period shorter than a second time period from a Q wave to a T wave of the heart. 22. The method of claim 20 comprising:delivering a second output of laser energy after a second time period shorter than a third time period from a T wave to a Q wave of the heart. 23. The method of claim 20 comprising:repeatedly delivering outputs of laser energy at a rate faster than the patient's heart rate before revascularization. 24. The method of claim 23, wherein the rate is faster than the patient's heart rate before revascularization by fewer than 20 outputs per minute.
25. The method of claim 20, wherein the output of laser energy comprises a set of pulses of laser energy.
26. The method of claim 20, comprising:introducing a catheter coupled to the laser energy source into the heart in a minimally invasive surgery (MIS) procedure. 27. The method of claim 20 comprising:pacing the heart before delivering the output. 28. The method of claim 20 comprising:pacing the heart after repeatedly delivering outputs of laser energy. 29. An apparatus for treating a patient's heart, the apparatus comprising:a catheter; a laser energy source coupled to the catheter; a shutter positioned to block energy from the laser energy source when the shutter is closed; and a control circuit that is configured to close the shutter to block laser energy and to open the shutter to allow the laser energy source to deliver an output of energy to the patient's heart, wherein the control circuit is configured to deliver the output of laser energy over a first time period wherein the output of laser energy is sufficient to cause one heartbeat, and the laser energy source and catheter are adapted to cause heartbeats by the delivery of the laser energy. 30. The apparatus of claim 29, wherein the control circuit is configured to deliver the output of laser energy wherein the first time period is shorter than a second time period from a Q wave to a T wave of the heart.
31. The apparatus of claim 29, wherein the control circuit is configured to deliver a second output of laser energy after a second time period equal to or shorter than a third time period from a T wave to a Q wave of the heart.
32. The apparatus of claim 29, wherein the control circuit is configured to deliver outputs of laser energy at a rate equal to or faster than the patient's heart rate before revascularization.
33. The apparatus of claim 32, wherein the rate of outputs is 20 outputs per minute faster than the patient's heart rate before revascularization.
34. The apparatus of claim 29, wherein the control circuit is configured to deliver the output of laser energy wherein the output of laser energy comprises a set of pulses of laser energy.
35. The apparatus of claim 34, wherein the set of pulses comprises a number of laser pulses in the range 1 to 4.
This application is a continuation in part application of U.S. patent application entitled REVASCULARIZATION WITH HEART PACING, application Ser. No. 08/793,000, Filed on Feb. 3, 1997, inventors: Murphy-Chutorian, Mueller.
The following applications are hereby incorporated herein by reference: U.S. patent application Ser. No. 08/852,977 Entitled ULTRASOUND DEVICE FOR AXIAL RANGING, Inventor(s): Zanelli, et. al. U.S. patent application Entitled METHOD AND APPARATUS FOR CREATION OF DRUG DELIVERY AND/OR STIMULATION POCKETS IN THE MYOCARDIUM, application Ser. No. 08/773,778, Filed on Dec. 23, 1996, inventor(s): Mueller; U.S. patent application Entitled METHOD AND APPARATUS FOR MECHANICAL TRANSMYOCARDIAL REVASCULARIZATION OF THE HEART, U.S. Pat. No. 5,871,495, Filed on Sep. 13, 1996, inventor(s): Mueller; U.S. patent application Entitled METHOD FOR NON-SYNCHRONOUS LASER ASSISTED TRANSMYOCARDIAL REVASCULARIZATION, U.S. Pat. No. 5,785,702, filed on Oct. 15, 1996, inventor(s): Murphy-Chutorian; and U.S. Patent Application Entitled MINIMALLY INVASIVE METHOD FOR FORMING REVASCULARIZATION CHANNELS, Application No. 08/794,733, inventor(s) Daniel et. al.
This invention relates generally to a method and apparatus for revascularization of a heart, and more particularly to a method and apparatus for revascularization using laser outputs.
An electrocardiogram signal may not always provide the most accurate indication of heart function. Further, the electrocardiogram signal is a passive indication of heart rate. It is not a method to control the rate at which the heart beats.
There is a need for an apparatus for stimulating revascularization of the heart or creating channels in the heart where the revascularization event caused by the revascularization device can occur at a selected time in relation to the heartbeat. There is a further need for an apparatus for treating a heart by stimulating revascularization of the heart or creating channels in the heart where the device can control the heartbeat rate. There is further need to reduce the number of cycles over which a laser must be fired to achieve the desired depth of channels in the heart.
Accordingly, an object of the invention is to provide an apparatus for stimulating revascularization of the beating heart or creating channels in the heart.
In one embodiment, the set of laser pulses comprises a number of laser pulses sufficient to cause one heartbeat per set of laser pulses. In one embodiment the set of laser pulses comprises a number of laser pulses to cause no more than one heartbeat per set of laser pulses.
FIG. 1 is a block diagram of a system for performing transmyocardial revascularization.
FIGS. 12a-12d are timing diagrams showing laser outputs and heart waves.
The apparatus and method of the present invention create channels or stimulation zones or both in the heart through a series of revascularization events. A revascularization device is used to create channels or stimulation zones in the heart. A revascularization device is one or more laser energy delivery devices (fired alone, simultaneously, or sequentially), a mechanical cutter, an ultrasound energy delivery device, or other device or devices for creating channels in heart tissue. A revascularization event is an action of the revascularization device as the device cuts, burns, lases, or otherwise creates or lengthens channels in the heart tissue. The channels or stimulation zones allow for improved bloodflow in heart tissue and/or help to stimulate regrowth of capillaries.
In an alternative embodiment signals from foot switch 22 or from sensor 32 or both could be input into microcomputer based timing controller 40 instead of into laser controller 42. In such a configuration, microcomputer based timing controller 40 would then provide appropriate signals to laser controller 42 partially in response to signals from foot switch 22 or from sensor 32. Also, instead of providing control to pulse generator 38, microcomputer based timing controller 40 could receive information from pulse generator 38 regarding the timing of pulses and then microcomputer based timing controller 40 would provide control to laser controller 42 in response to the timing of pulses. Microcomputer based timing controller 40 is a microcomputer that runs a set of software instructions recorded in a memory. Alternatively, integrated circuit logic may be used to perform the function of microcomputer based timing controller 40.
Pulse generator 38 provides the pacing signal to the patient's heart or to another location on the patients body in order to pace the patient's heart via pacing leads 24. Pulse generator 38 may be a heart pacemaker such a modified model 540 External Pulse Generator, SeaMED Corp., Redmond, Wash. The pacemaker is modified such that it generates a pulse to the pacing leads when it receives an external logic signal. Alternatively, pulse generator 38 is any artificial energy source capable of causing the heart to beat. For example, the same revascularization device used to create channels, such as a laser, may be used to pace the heart as channels are created by timing the revascularization events to match the natural heart rate or to synchronize with the heart rate. In such a case where a laser or other revascularization device is used to pace the heart, the artificial energy source and the revascularization are the same device.
In a preferred embodiment laser 28 is a holmium laser available as an Eclipse 40001 holmium laser from Eclipse Surgical Technologies, Inc., Sunnyvale, Calif. Other types of medical lasers may also be used, for example, an excimer laser, a CO. laser, an Argon laser, a Nd-yag laser, an erbium laser, or a diode laser. A medical laser having a wavelength in the range of 308 milimeters to 10.6 micrometers may be used. A single laser may be used, or multiple lasers or multiple fibers from a single laser can be used in order to cause more revascularization to occur at one time. For a discussion of tuning of a laser for revascularization, see U.S. Patent Application entitled Method for Non-Synchronous Laser Assisted Transmyocardial Revascularization, Application No. 08/729325, filed on Oct. 15, 1996, which is incorporated herein by reference. As an alternative to a laser revascularization device, another revascularization device such as a mechanical cutter or an ultrasound energy delivery device may be used in order to create channels in the heart or to revascularize the heart. The revascularization device can be coupled to a catheter for percutaneous and minimally invasive surgery (MIS) approaches. Alternatively, the revascularization device can be used directly in open heart surgery. If the revascularization device is coupled to a catheter, it can be introduced percutaneously and moved into the heart through the vasculature.
In an alternative embodiment, microcomputer based timing controller 40 is configured to cause laser 28 to deliver multiple laser pulses for each pace signal which are used to help create a greater depth of revascularization per heartbeat or to create a series of stimulation pockets connected by narrow channels. If multiple lasers or multiple fibers from one laser are used, then multiple channels can also be created simultaneously. In another embodiment, microcomputer based timing controller 40 can be configured to cause laser 28 to deliver revascularization events to the patient's heart at a time in the heartbeat cycle so that the revascularization event also causes a heartbeat. After a beat is created by a laser pulse, another laser pulse is delivered to create a revascularization event. In this mode of operation when footswitch 22 is activated, the pulse generator 38 is disabled and one or more revascularization events are delivered to patient's 26 heart during a time that the pacemaker signal would have been delivered. In this manner the laser can be used to pace the patients heart.
FIG. 3a includes pace signal 46a, footswitch signal 50a, and a laser burst signal 54a. Signal 55a occurs after pace signal 46a is active at 47a. Thus, a revascularization occurs after the heart is paced. As shown, laser bursts 55a and 55a' occur only when foot switch signal 50a is active. Laser burst signals 55a and 55a' occur after pace signal 47a but before pace signal 47a'. Laser burst signals 55a " and 55a"' occur after the pace signal 47a'.
FIG. 3d is a timing diagram for revascularization with heart pacing including laser pulses that cause heartbeats. Electrocardiogram signal 56d is not used to control the laser burst or the periods at which they occur. As seen in the FIG. 3d, the heart rate before pace signal 47d is slower than the heart rate after pace signal 47d. Between the pace signal 47d and 47d' the heart beats in response to the laser bursts 55d, 55d', 55d", and 55d"'. As shown in FIG. 3d the revascularization events or the laser bursts occur at a time at which they cause the heart to beat.
FIG. 3f illustrates revascularization with heart pacing including multiple laser pulses per heartbeat cycle. FIG. 3f includes electrocardiogram signal 56f, pace signal 46f, and laser burst signal 54f. Electrocardiogram signal 56f or signal from another type of sensor (e.g. pressure sensor) can be used to observe whether the heart is beating efficiently and to disable the laser if the heart is not beating. Laser bursts 55f and 55f' occur after pace signal 47f and after R wave 57f and before T wave 57f'. Multiple laser bursts 55f and 55f' are provided in order to allow for possibly greater depth of revascularization per heartbeat cycle or to create stimulation zones with or without connecting channels. The rate at which the heart is paced is faster than the unpaced rate of the heart. As seen in FIG. 3f; the time between heartbeat signals on the electrocardiogram signal 56f is greater before first pace signal 47f than the time between heartbeat signals after pace signal 47f. It may be desirable to cause a revascularization event to occur after a depolarization of the heart and before a repolarization of the heart.
As shown in FIG. 3g, first pulse 55g is stronger than subsequent pulses 55g, 55g', 55g", and 55g"' in order to allow the first pulse to pace the heart and subsequent pulses to be used to revascularize or create a channel into the heart. The heart beats in response to first laser pulse 55g. Alternatively, first laser pulse 55g can be smaller than the subsequent ones so that the first pulse is large enough to pace and subsequent ones are larger for greater revascularization.
FIG. 4b is a perspective view of a fiber optic laser energy delivery device handpiece 62 with pacing leads as could be used for surgical paced revascularization or, with modifications, in MIS applications. Handpiece 62 is for controllably advancing a fiber. Such a handpiece is available under the name Sologrip i' from Eclipse Surgical Technologies, Sunnyvale, Calif. FIG. 4b shows electrode end 64c, electrode 64e, electrode 64d, and fiber optic fibers 65. The electrode 64d and electrode 64e are located at the distal end of the laser energy delivery device handpiece 62 and extend though the laser energy delivery device handpiece 62. The location of the electrodes 64d and 64e provides the pacing signal close to the location of revascularization.
Referring now to FIGS. 5a to 5d, embodiments of a catheter with fiber optics 86 are illustrated. The FIGS. 5a to 5d show fiber bundles; however, it is appreciated that single fibers, waveguides, lenses used with fibers, or lenses in articulated arms could also be used. In FIG. 5a the fibers 86 are surrounded by handle 80. A slot 82 is configured to receive a control knob. FIG. 5b shows a handle 80' and a slot 84 through handle 80'. Slot 84 may be used for a control knob or control block to slide fibers 86 through the body of handle 80. FIG. 5c shows glass fibers 86 in a bundle of fibers. Alternatively, a single fiber, wave guide, or CO2 laser handpiece may be used. FIG. 5d shows a protective sheath 90 over a bundle of fibers including fibers 86. A marker 88 is positioned around fibers 86. Marker 88 is comprised of tantalum or similar material. Epoxy 92 holds fibers 86 together.
As shown in FIG. 6, paced revascularization can be performed percutaneously. A revascularization device 94 is introduced percutaneously into the vasculature and moved into the heart 98. Revascularization device 94 is used to create channels 108', 108", and 108"' in heart 98. Here the channels are shown in the left ventricle 108. The revascularization channels 108', 108", and 108"' help to improve blood flow to the heart and help to stimulate the regrowth of capillaries. Channels extend from the ventricle partway through the myocardium.
Laser output is performed using a laser such as a C02 laser, an excimer laser, or a holmium laser. Other lasers may also be used. The holmium laser is a solid state laser requiring some settle down time. In order to allow the holmium laser to settle down three or four laser pulses of the holmium laser are fired but are not delivered to the patient. These pulses are shuttered from the catheter 150 using the shutter 132 as controlled by shutter control code 142. Not all lasers require the settle down time and thus not all lasers require a shutter.
The foregoing description of a preferred embodiment of the invention has been presented for purposes of illustration and description. It is not intended to be exhaustive or to limit the invention to the precise forms disclosed. Obviously, many modifications and variations will be apparent to practitioners skilled in this art. It is intended that the scope of the invention be defined by the following claim and their equivalents.
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