WO1999007296A1 - System and method of intra-operative myocardial revascularization using pulsed sonic energy - Google Patents
System and method of intra-operative myocardial revascularization using pulsed sonic energy Download PDFInfo
- Publication number
- WO1999007296A1 WO1999007296A1 PCT/US1998/016528 US9816528W WO9907296A1 WO 1999007296 A1 WO1999007296 A1 WO 1999007296A1 US 9816528 W US9816528 W US 9816528W WO 9907296 A1 WO9907296 A1 WO 9907296A1
- Authority
- WO
- WIPO (PCT)
- Prior art keywords
- heart
- sonic energy
- patient
- probe member
- pulsed sonic
- Prior art date
Links
Classifications
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/22—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for
- A61B17/22004—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves
- A61B17/22012—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement
- A61B17/2202—Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for using mechanical vibrations, e.g. ultrasonic shock waves in direct contact with, or very close to, the obstruction or concrement the ultrasound transducer being inside patient's body at the distal end of the catheter
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B18/04—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating
- A61B18/12—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by heating by passing a current through the tissue to be heated, e.g. high-frequency current
- A61B18/14—Probes or electrodes therefor
- A61B18/1492—Probes or electrodes therefor having a flexible, catheter-like structure, e.g. for heart ablation
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods, e.g. tourniquets
- A61B17/00234—Surgical instruments, devices or methods, e.g. tourniquets for minimally invasive surgery
- A61B2017/00238—Type of minimally invasive operation
- A61B2017/00243—Type of minimally invasive operation cardiac
- A61B2017/00247—Making holes in the wall of the heart, e.g. laser Myocardial revascularization
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
- A61B2018/00315—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body for treatment of particular body parts
- A61B2018/00345—Vascular system
- A61B2018/00351—Heart
- A61B2018/00392—Transmyocardial revascularisation
Definitions
- This invention generally relates to the field of heart tissue removal, and more particularly to the use of pulsed sonic energy for myocardial revascularization to improve the flow of blood to the heart muscle and cure angina.
- Myocardial revascularization typically involves formation of one or more channels in a patient's heart wall defining the heart chamber to treat a patient's ischemic myocardial tissue therein.
- the first trials of the revascularization process was made by Mirhoseini et al. See for example the discussions in Lasers in General Surgery (Williams & Wil ins; 1989), pp 216-223. Another early disclosure of this procedure is found in U.S. Patent 4,658,817 (Hardy). Both of these references describe laser myocardial revascularization (LMR) procedures in which a laser is used to form the revascularization channels through the epicardium, myocardium and endocardium.
- LMR laser myocardial revascularization
- LMR low cost yet reliable myocardial revascularization system
- the present invention generally involves use of a pulsed sonic energy apparatus for the removal of heart tissue, including both the ablation of the tissue and the formation of channels in the tissue.
- a pulsed sonic energy apparatus for the removal of heart tissue, including both the ablation of the tissue and the formation of channels in the tissue.
- One aspect of the invention provides a method for ablating tissue of a patient's heart comprising, providing a pulsed sonic energy apparatus with an elongated probe member. The probe member contacts the patient's heart tissue, and transmits bursts of pulsed sonic energy to the heart tissue.
- a system for forming a channel in a patient's heart wall comprising an elongated probe member connected to a source of bursts of pulsed sonic energy.
- the transverse dimension, or diameter, of the probe member is essentially the same as the size of the channel to be formed.
- the energy bursts are delivered in a timed sequence, which may be either dependent or independent of the patient's heart cycle. By providing the sonic energy bursts at a specific frequency and pulse duration, the removal of the heart tissue can be optimally controlled.
- Fig. 1 is a schematic section of a human heart showing revascularization of the myocardium according to the invention.
- Fig. 2 is a schematic block diagram of a pulsed sonic energy system synchronized to a heart beat according to the invention.
- a pulsed sonic energy generator 10 of the invention generally comprises a source of pulsed sonic energy 11 and a transmitting device 12 including an elongated probe member 13.
- the elongated probe member 13 is inserted into the chest cavity.
- Elongated probe member 13 is then placed in contact with an area of the heart 16, such as a ventricle 17, having an area 18 in need of increased blood circulation due to cardiovascular disease. Portions of the heart other than ventricles 17 might also be revascularized by this method. Pulsed sonic energy is transmitted in a plurality of bursts through the elongated probe member 13 of the transmitting device 12 to the patient's heart tissue in contact therewith. A number of channels 20 can then be formed by the elongated probe member 13 from the outer wall, or epicardium 21 , and extend through the myocardium 22. The channel can optionally perforate the interior of the heart wall, or endocardium 23.
- the elongated probe member 13 is shaped to facilitate contact with a region of the patient's heart, e.g. with a bend, into a desired configuration (not shown).
- One aspect of the invention provides a system for forming a channel of desired transverse dimensions in a wall of a patient's heart.
- the system comprises an elongated probe member 13, a source of a plurality of bursts of pulsed sonic energy 11 , and means to connect the source 11 to the proximal extremity of the probe member 13.
- the elongated probe member 13 having a proximal end 14 and a distal end 15, when in contact with tissue, cuts a channel essentially equal to the transverse dimension of the probe member distal end 15.
- the means to connect the pulsed sonic energy source 11 has a handle means (not shown) to enable an operator to press the distal extremity of the probe member 13 into contact with the patient's heart wall to form a channel.
- the handle means facilitates pressing the probe member distal extremity perpendicularly against the patient's heart wall.
- the heart beat is preferably monitored, and the sonic energy source 11 is preferably gated to generate one or more pulses during contractions (systole) of the heart, and to generate no pulses during the rest of the heart cycle.
- the presently preferred pulse duration is no more than 100 milliseconds.
- a plurality of bursts of pulsed sonic energy may be required to complete the channel 20 in the heart wall.
- the presently preferred frequency of the pulsed sonic energy emitted from the pulsed sonic energy source is at least 15,000 Hz.
- the sonic energy includes, for example, ultrasound, and the presently preferred source of pulsed sonic energy is an ultrasonic generator.
- the ultrasound generator drives a transducer operating at resonance coupled to the elongated probe member 13.
- pulsed sonic energy is delivered to the heart tissue in a sequence dependent on the patient's heart beat cycle.
- the R wave is one of four distinct waveforms that exist in each heart beat cycle.
- Fig. 2 illustrates a schematic block diagram of a pulsed sonic energy system in which a +5 volt pulse is produced from an ECG monitor 31 for each R wave of a beating heart.
- the ECG +5 volt pulse is sent to a one shot trigger generator 32, where it triggers a variable width pulse.
- the variable width pulse is typically no greater than 100 msec, and is sent from the one shot 32 to a NAND gate 33. When the system is turned on, the NAND gate 33 switch will close, in response to the variable width pulse from the one shot.
- the closed NAND gate sends a signal to a NPN transistor 34, which in turn energizes a reed relay 36, which triggers an ultrasonic generator 38 for a time that approximates the pulse width of the one shot.
- a foot switch connector may be provided so that the physician may selectively energize the elongated probe member 13 with ultrasonic energy for the formation of channels 20.
- the ECG monitor 31 may be a standard model, such as is available from Hewlett-Packard Company.
- the one shot trigger generator 32 and NAND gate 33 may be readily obtainable models, such as National Semiconductor models CD4047 BM, and CD 4011 BM respectively.
- the ultrasound generator 38 may be, for example, the MISSONIX generator, or another readily obtainable generator.
- the distal end of the elongated probe member 13 may be maintained in position on the outer heart wall by a gentle pressure that advances the elongated probe member, to insure that the member 13 is not dislodged in the formation of the channel 20 between pulses of the sonic energy.
- a gentle pressure that advances the elongated probe member, to insure that the member 13 is not dislodged in the formation of the channel 20 between pulses of the sonic energy.
- as few as one pulse of sonic energy per heartbeat is transmitted to the heart tissue.
- an energized probe member 13 contacting the heart surface at a non-perpendicular angle has an increased risk of producing a heart arrhythmia.
- the elongated probe member 13 is held by the operator at an angle of approximately 90° to the heart surface.
- the elongated probe member is maintained in the perpendicular orientation relative to the surface of the beating heart by an orientation means (not shown).
- the orientation means comprises for example, a track in which the elongated probe member 13 proximal end 14 slides, wherein the probe member distal end 15 extends beyond the distal end of the tract and into the patient.
Abstract
Description
Claims
Priority Applications (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
EP98940826A EP1001708A1 (en) | 1997-08-07 | 1998-08-07 | System and method of intra-operative myocardial revascularization using pulsed sonic energy |
AU89015/98A AU8901598A (en) | 1997-08-07 | 1998-08-07 | System and method of intra-operative myocardial revascularization using pulsed sonic energy |
Applications Claiming Priority (2)
Application Number | Priority Date | Filing Date | Title |
---|---|---|---|
US90824697A | 1997-08-07 | 1997-08-07 | |
US08/908,246 | 1997-08-07 |
Publications (2)
Publication Number | Publication Date |
---|---|
WO1999007296A1 true WO1999007296A1 (en) | 1999-02-18 |
WO1999007296A9 WO1999007296A9 (en) | 1999-04-29 |
Family
ID=25425439
Family Applications (1)
Application Number | Title | Priority Date | Filing Date |
---|---|---|---|
PCT/US1998/016528 WO1999007296A1 (en) | 1997-08-07 | 1998-08-07 | System and method of intra-operative myocardial revascularization using pulsed sonic energy |
Country Status (3)
Country | Link |
---|---|
EP (1) | EP1001708A1 (en) |
AU (1) | AU8901598A (en) |
WO (1) | WO1999007296A1 (en) |
Cited By (15)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US6217575B1 (en) | 1999-02-24 | 2001-04-17 | Scimed Life Systems, Inc. | PMR catheter |
US6468271B1 (en) | 1999-02-24 | 2002-10-22 | Scimed Life Systems, Inc. | Device and method for percutaneous myocardial revascularization |
US6508783B2 (en) | 2001-03-14 | 2003-01-21 | Scimed Life Systems, Inc. | Ultrasound method for revascularization and drug delivery |
US6533779B2 (en) | 2001-01-16 | 2003-03-18 | Scimed Life Systems, Inc. | PMR catheter and associated methods |
US6544220B2 (en) | 2001-02-14 | 2003-04-08 | Scimed Life Systems, Inc. | Fluid jet PMR |
US6669691B1 (en) | 2000-07-18 | 2003-12-30 | Scimed Life Systems, Inc. | Epicardial myocardial revascularization and denervation methods and apparatus |
US7704222B2 (en) | 1998-09-10 | 2010-04-27 | Jenavalve Technology, Inc. | Methods and conduits for flowing blood from a heart chamber to a blood vessel |
US10993805B2 (en) | 2008-02-26 | 2021-05-04 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US11065138B2 (en) | 2016-05-13 | 2021-07-20 | Jenavalve Technology, Inc. | Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system |
US11185405B2 (en) | 2013-08-30 | 2021-11-30 | Jenavalve Technology, Inc. | Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame |
US11337800B2 (en) | 2015-05-01 | 2022-05-24 | Jenavalve Technology, Inc. | Device and method with reduced pacemaker rate in heart valve replacement |
US11357624B2 (en) | 2007-04-13 | 2022-06-14 | Jenavalve Technology, Inc. | Medical device for treating a heart valve insufficiency |
US11517431B2 (en) | 2005-01-20 | 2022-12-06 | Jenavalve Technology, Inc. | Catheter system for implantation of prosthetic heart valves |
US11564794B2 (en) | 2008-02-26 | 2023-01-31 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US11589981B2 (en) | 2010-05-25 | 2023-02-28 | Jenavalve Technology, Inc. | Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent |
Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4658817A (en) | 1985-04-01 | 1987-04-21 | Children's Hospital Medical Center | Method and apparatus for transmyocardial revascularization using a laser |
WO1987005793A1 (en) * | 1986-04-02 | 1987-10-08 | Cooper Lasersonics, Inc. | Method and apparatus for ultrasonic surgical fragmentation |
EP0310431A2 (en) * | 1987-09-30 | 1989-04-05 | Valleylab, Inc. | Apparatus for providing enhanced tissue fragmentation and/or hemostasis |
US4936281A (en) * | 1989-04-13 | 1990-06-26 | Everest Medical Corporation | Ultrasonically enhanced RF ablation catheter |
WO1992011815A2 (en) * | 1991-01-11 | 1992-07-23 | Baxter International Inc. | Ultrasonic angioplasty device incorporating transmission member and ablation probe |
WO1994006355A1 (en) * | 1992-09-14 | 1994-03-31 | Coraje, Inc. | Apparatus and method for enhanced intravascular phonophoresis including dissolution of intravascular blockage and concomitant inhibition of restenosis |
WO1996029935A1 (en) * | 1995-03-31 | 1996-10-03 | Boston Scientific Corporation | Acoustic ablation |
US5827203A (en) * | 1997-04-21 | 1998-10-27 | Nita; Henry | Ultrasound system and method for myocardial revascularization |
-
1998
- 1998-08-07 EP EP98940826A patent/EP1001708A1/en not_active Withdrawn
- 1998-08-07 AU AU89015/98A patent/AU8901598A/en not_active Abandoned
- 1998-08-07 WO PCT/US1998/016528 patent/WO1999007296A1/en not_active Application Discontinuation
Patent Citations (8)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US4658817A (en) | 1985-04-01 | 1987-04-21 | Children's Hospital Medical Center | Method and apparatus for transmyocardial revascularization using a laser |
WO1987005793A1 (en) * | 1986-04-02 | 1987-10-08 | Cooper Lasersonics, Inc. | Method and apparatus for ultrasonic surgical fragmentation |
EP0310431A2 (en) * | 1987-09-30 | 1989-04-05 | Valleylab, Inc. | Apparatus for providing enhanced tissue fragmentation and/or hemostasis |
US4936281A (en) * | 1989-04-13 | 1990-06-26 | Everest Medical Corporation | Ultrasonically enhanced RF ablation catheter |
WO1992011815A2 (en) * | 1991-01-11 | 1992-07-23 | Baxter International Inc. | Ultrasonic angioplasty device incorporating transmission member and ablation probe |
WO1994006355A1 (en) * | 1992-09-14 | 1994-03-31 | Coraje, Inc. | Apparatus and method for enhanced intravascular phonophoresis including dissolution of intravascular blockage and concomitant inhibition of restenosis |
WO1996029935A1 (en) * | 1995-03-31 | 1996-10-03 | Boston Scientific Corporation | Acoustic ablation |
US5827203A (en) * | 1997-04-21 | 1998-10-27 | Nita; Henry | Ultrasound system and method for myocardial revascularization |
Non-Patent Citations (1)
Title |
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WILLIAMS & WILKINS: "LASERS IN GENERAL SURGERY", 1989, pages: 216-223 |
Cited By (21)
Publication number | Priority date | Publication date | Assignee | Title |
---|---|---|---|---|
US7704222B2 (en) | 1998-09-10 | 2010-04-27 | Jenavalve Technology, Inc. | Methods and conduits for flowing blood from a heart chamber to a blood vessel |
US8597226B2 (en) | 1998-09-10 | 2013-12-03 | Jenavalve Technology, Inc. | Methods and conduits for flowing blood from a heart chamber to a blood vessel |
US8216174B2 (en) | 1998-09-10 | 2012-07-10 | Jenavalve Technology, Inc. | Methods and conduits for flowing blood from a heart chamber to a blood vessel |
US7736327B2 (en) | 1998-09-10 | 2010-06-15 | Jenavalve Technology, Inc. | Methods and conduits for flowing blood from a heart chamber to a blood vessel |
US6468271B1 (en) | 1999-02-24 | 2002-10-22 | Scimed Life Systems, Inc. | Device and method for percutaneous myocardial revascularization |
US6217575B1 (en) | 1999-02-24 | 2001-04-17 | Scimed Life Systems, Inc. | PMR catheter |
US6669691B1 (en) | 2000-07-18 | 2003-12-30 | Scimed Life Systems, Inc. | Epicardial myocardial revascularization and denervation methods and apparatus |
US7063696B2 (en) | 2000-07-18 | 2006-06-20 | Boston Scientific Scimed, Inc. | Epicardial myocardial revascularization and denervation methods and apparatus |
US6533779B2 (en) | 2001-01-16 | 2003-03-18 | Scimed Life Systems, Inc. | PMR catheter and associated methods |
US6544220B2 (en) | 2001-02-14 | 2003-04-08 | Scimed Life Systems, Inc. | Fluid jet PMR |
US6702775B2 (en) | 2001-03-14 | 2004-03-09 | Scimed Life Systems, Inc. | Ultrasound method for revascularization and drug delivery |
US6508783B2 (en) | 2001-03-14 | 2003-01-21 | Scimed Life Systems, Inc. | Ultrasound method for revascularization and drug delivery |
US11517431B2 (en) | 2005-01-20 | 2022-12-06 | Jenavalve Technology, Inc. | Catheter system for implantation of prosthetic heart valves |
US11357624B2 (en) | 2007-04-13 | 2022-06-14 | Jenavalve Technology, Inc. | Medical device for treating a heart valve insufficiency |
US11564794B2 (en) | 2008-02-26 | 2023-01-31 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US10993805B2 (en) | 2008-02-26 | 2021-05-04 | Jenavalve Technology, Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US11154398B2 (en) | 2008-02-26 | 2021-10-26 | JenaValve Technology. Inc. | Stent for the positioning and anchoring of a valvular prosthesis in an implantation site in the heart of a patient |
US11589981B2 (en) | 2010-05-25 | 2023-02-28 | Jenavalve Technology, Inc. | Prosthetic heart valve and transcatheter delivered endoprosthesis comprising a prosthetic heart valve and a stent |
US11185405B2 (en) | 2013-08-30 | 2021-11-30 | Jenavalve Technology, Inc. | Radially collapsible frame for a prosthetic valve and method for manufacturing such a frame |
US11337800B2 (en) | 2015-05-01 | 2022-05-24 | Jenavalve Technology, Inc. | Device and method with reduced pacemaker rate in heart valve replacement |
US11065138B2 (en) | 2016-05-13 | 2021-07-20 | Jenavalve Technology, Inc. | Heart valve prosthesis delivery system and method for delivery of heart valve prosthesis with introducer sheath and loading system |
Also Published As
Publication number | Publication date |
---|---|
EP1001708A1 (en) | 2000-05-24 |
WO1999007296A9 (en) | 1999-04-29 |
AU8901598A (en) | 1999-03-01 |
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