Eclipse Surgical Technologies, Inc.

Other

Stuart D Harman

Richard L Mueller

Douglas R Murphy-Chutorian

Bruce J Richardson

Steven A Daniel

Steve A Daniel

Rick Emerson

Larry Witham

Alexander K Khairkhahan

Michael J Horzewski

Richard Dean Phipps

Robert L Lathrop, Jr

Kenneth G Olson

Mark Roush

Timothy C Reynolds

Michael J Rosinko

Gabriele Bungardt

Jeffrey J Giba

Fred G Kinley

Richard L Mueller, Jr

Robert Lincoln Lathrop, Iii

Kevin L Moss

Henry N Padilla

A drug delivery apparatus for dispensing predetermined volumes of drug, drug solution or other substances into an opening, such as a TMR channel in the human heart, or other laser treated area within the human body, the apparatus consisting of a bifurcated needle with a laser inlet for guiding a laser delivery means, such as an optical fiber or fiber bundle, to adjacent a surface of the human heart or other body structure for creating an opening, such as a TMR channel, or other laser treated area thereon. A drug inlet is for receiving the drug and transmitting the drug to the TMR channel or other laser treated area. Optionally, a piercing tip and/or suction device assists in positioning the apparatus adjacent the tissue to be treated. Drug is dispensed by manually or automatically actuating a piston or syringe element. A method of use is also disclosed.

Laser assisted drug delivery

An apparatus for stimulating revascularization of myocardium tissue in the ventricular wall of a human heart is disclosed. The apparatus includes means for moving the distal end of an optical fiber element forwardly through the epicardium of the heart and into the myocardium and emitting relatively low power bursts of laser energy from the distal end to form stimulus injury zones that promote capillary growth and tissue revascularization. Each penetration of the optical fiber element may produce multiple stimulus zones spaced radially from or in line with the axis of the optical fiber element. Apparatus for moving the optical fiber element and controlling the laser emissions in a predetermined manner is also disclosed.

Intraoperative myocardial device and stimulation procedure

A steerable percutaneous catheter for guiding at least one functional device to selected surfaces of a body for treatment thereon, particularly adapted for laser-assisted Percutaneous Transmyocardial Revascularization (PTMR). The steerable catheter has a handle portion at its proximal end and a controllably deflectable end portion at its distal end. The distal end of the catheter and the distal end of the functional device maintain alignment automatically during deflection. The invention also includes a surface contact detection system to detect contact with an interior body surface, such as the heart wall.

Steerable catheter with tip alignment and surface contact detector

A viewing and treatment apparatus for performing minimally invasive surgery through an opening in a patient's chest, the apparatus includes a visualization scope with an elongated portion and a distal end, and a working device such as a tissue ablation energy delivery device. The working device is encompassed within a working channel that communicates with the distal end of the scope. In one embodiment, a bronchoscope is used whose catheter shafting includes an introducer sleeve at the distal section of the scope for providing stability during introduction to a patient's chest while stabilizing the treatment and visualization distal ends of the scope at a treatment site. This embodiment can include a needle piercing assembly that cooperatively works with the working device such as for drug delivery. In a second embodiment a rigid endoscope with a viewing channel has an introducer member that is slidably disposed and detachable from the viewing channel and has a transparent convex distal tip which provides non-articulation at the distal end. This introducer member can also be used in conjunction with the first embodiment where the catheter shaft requires non-articulation. Both types of visualization scopes include a working channel in which the working device can translationally egress from the scope's distal end. Additionally, the rigid introducer member can be modified to include a movable transparent rotatable member design for varying the direction which the working devices egresses the apparatus' distal end.

Viewing surgical scope for minimally invasive procedures

A steerable drug delivery catheter and method of use, particularly adapted for percutaneous use. The distal end of the drug delivery catheter is deflectable. The catheter has a relative movement compensation mechanism for maintaining positioning between the distal end of the drug delivery catheter and the distal end of the drug delivery device therein.

Drug delivery catheter with tip alignment

A viewing and treatment apparatus for performing minimally invasive surgery through an opening in a patient's chest, the apparatus includes a visualization scope with an elongated portion and a distal end, and a working device such as a tissue ablation energy delivery device. The working device is encompassed within a working channel that communicates with the distal end of the scope. In one embodiment, a bronchoscope is used whose catheter shafting includes an introducer sleeve at the distal section of the scope for providing stability during introduction to a patient's chest while stabilizing the treatment and visualization distal ends of the scope at a treatment site. This embodiment can include a needle piercing assembly that cooperatively works with the work device such as for drug delivery. In a second embodiment a rigid endoscope with a viewing channel has an introducer member that is slidably disposed and detachable from the viewing channel and has a transparent convex distal tip which provides non-articulation at the distal end. This introducer member can also be used in conjunction with the first embodiment where the catheter shaft requires non-articulation. Both types of visualization scopes include a working channel in which the working device can translationally egress from the scope's distal end. Additionally, the rigid introducer member can be modified to include a movable transparent rotatable member design for varying the direction which the working devices egresses the apparatus' distal end. The preferred surgical procedure is transmyocardial revascularization and the preferred working device is an optical fiber element that is translatable from the distal end of the apparatus during the procedure. The working device can optionally include a flexible piercing needle with an internal lumen which allows translation of a working device such as an optical fiber or act as a conduit for drug delivery.

The apparatus for combined mechanical/laser myocardial revascularization of a human heart includes: inserting a mechanical piercing device and an elongated flexible lasing apparatus into the chest cavity of a patient; mechanically auto-piercing, micro-tearing or spreading the epicardium of the heart; and then lasing from beneath the epicardium through the myocardium. The apparatus is guided to an area exterior to a ventricle of the patient's heart, and the distal end of the energy delivery device such as an optical fiber apparatus is placed internal to the exterior wall of the heart through an opening which has been created by mechanically piercing, micro-tearing or spreading the epicardium, so that the myocardium and not the epicardium is irradiated with laser energy to allow passage of said energy delivery device such as an optical fiber distal end or said laser energy into the left ventricular cavity without causing a laser irradiation of the epicardium which might be a cause of operative bleeding and for better allowing the sealing of the epicardium after the apparatus is removed. The apparatus includes a hand-held device controllable by the physician having a removable distal head portion with an auto-piercing mechanism and can use a vacuum source to provide a suction force at the head portion. The auto-piercing mechanism is implemented by various ways such as a spring-biased actuating member in the TMR hand-held device and an electro-mechanical operated piercing mechanism. The hand-held TMR device with handle assembly can also be controlled by a computer to provide auto- sequencing of the auto-piercing needle mechanism and the laser firing with auto-fiber advancement.

Laser device with auto-piercing tip for myocardial revascularization

Improved methods and devices related to laser-assisted transmyocardial revascularization (TMR), and more particularly, to improved methods and devices for creating branched TMR channels through myocardium in which a single opening is made in an epicardial surface with a plurality of channel branches, having predetermined geometries extending into and through myocardium, depending therefrom. A method of creating branched TMR channels comprises piercing an epicardial surface mechanically or with laser energy, directing laser energy through the opening in a first predetermined angular orientation with respect to the epicardial surface to create a first channel and delivering laser energy in a second predetermined angular orientation to create a second branch. A plurality of branches can thus be created in a single channel structure. A guide block device allows an opening to be made in an epicardial surface mechanically or with laser energy and provides a structure for directing laser energy into myocardium in a plurality of channels depending from the opening. Rotating guide devices and finger held devices with rotating head means include a hand held device with an elongated wand-like handle portion, a rotating head portion and a hollow guide needle means. Preferred embodiments further comprise a laser delivery means advancing mechanism and guide needle rotating means.

Contiguous, branched transmyocardial revascularization (TMR) channel,

A laser surgery device for performing laser myocardial revascularization procedures on a human heart comprises a hand-held body portion with a forwardly extending probe member with an enlarged head end assembly including a piercing tip. A movable fiber bundle connected to a laser source extends through the body portion and the probe member with its distal tip at the head end assembly. A control button on the body portion enables the device to move the distal tip forwardly from the head end, and selectable stop members are provided on the body portion to provide different travel distances for the optical fiber bundle during a procedure. The body portion has a rotatable nose-piece with an internal ratchet mechanism which enables the device user to rotate the probe member and its head end to a selected optimum position before commencing a procedure. The head end assembly includes an easily replaceable piercing member in combination with a concave disk having a yieldable liner for cushioning the head assembly contact with the patient's heart. The device is used with a TMR procedure wherein the epicardium is initially pierced to provide access to the myocardium for the distal tip of the fiber bundle which then emits laser pulses as it is moved through the myocardium.

Laser device for transmyocardial revascularization procedures

A heart stabilizer and suture control device for stabilizing the heart and for occluding a preselected portion of coronary artery by developing a downward force on the heart and simultaneously developing an upward force across a coronary artery in a predetermined position. The device has at least two stabilization pads, the stabilization pads each having an operative size and shape, and each having a first end and a second end and a lower contacting surface. The second ends have suture retaining grooves, and the stabilization pad has a suture locking means for securing the distal end of a suture means thereto. The device also comprises a linking member locking the two stabilization pads an operative distance apart. The device has suture means with a proximal end coupled to the linking member and extending from the first end to the suture retaining groove of the second end, the suture means having a distal end which can be locked to the stabilization pad with the suture locking means thereon. The device also has means for rotating the linking member such that when operatively positioned adjacent a coronary artery to be occluded with the suture threaded between the coronary artery and the remaining portion of the heart muscle, rotating the linking member will cause the proximal end of the suture means to be wound onto the linking member and thus tighten the suture between the first end and the second end of each stabilization pad and urge the coronary artery against the contacting surface, thereby causing occlusion of the coronary artery as desired.

Heart stabilizer with controllable stay suture and cutting element

A drug delivery apparatus for dispensing a predetermined amount of one or more drugs into a laser created opening in the human body, the apparatus consisting of a laser delivery means such as an optical fiber or fiber bundle, a drug conduit which transfers the one or more drugs, drug solutions or other substances to the distal end of the laser delivery means, and the laser delivery means disposed essentially coaxially with the drug conduit. Laser delivery means is used to create a TMR channel or other opening in the body. Dispensed drug or other substance travels through the drug conduit and emanates from the drug conduit to be delivered into the TMR channel or other laser created opening. Drug is dispensed by manually or automatically activating an electric motor which actuates a piston element. A method of use is also disclosed.

Laser delivery means adapted for drug delivery

A method of selecting laser parameters for performing laser-assisted myocardial revascularization to avoid inducing undesired cardiac arrhythmia without synchronization of delivery of laser energy and the patient's cardiac cycle, the method comprising the steps of minimizing the power level of laser energy used, thereby decreasing the overall trauma to the heart, selecting a pulse frequency as great as possible while avoiding adverse summation effects, selecting a pulse width as wide as possible to prevent excessively high peak powers per pulse and not so wide as to cause undesired thermal damage, selecting an energy flux rate, shaping the front end of each pulse of laser energy to provide efficient, non-explosive TMR channeling, and correcting the selected power level, pulse width, pulse frequency and energy flux rate for mechanical events, including method of access to the heart, position of selected portions of myocardium in the heart, temporal duration of the procedure, natural movement of the heart, specific heart geometry, pre-existing heart arrhythmia and other factors causing a predisposition to heart arrhythmia. A method for performing laser-assisted transmyocardial revascularization (TMR) and percutaneous transluminal myocardial revascularization (PTMR) using such laser energy with parameters selected to avoid inducing undesired cardiac arrhythmia, the method comprising the steps of generating laser energy having a predetermined non-square wave shape, a predetermined wavelength, a predetermined energy flux and a predetermined power level, and delivering the laser energy in a plurality of pulses, the plurality of pulses having a predetermined pulse frequency and a predetermined pulse width, to selected portions of myocardium to form TMR and PTMR channels without synchronizing delivery of the laser beam with the cardiac cycle.

Growing community of inventors

San Jose, CA, United States of America

Stuart D Harman