JPH1147147A - Proximate branched trans-myocardial revasculization channel, method and device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide an improved method and device for laser-assisted trans- myocardial revasculization(TMR). SOLUTION: An improved method and device are provided for forming a branched TMR channel through a myocardium 104, the TMR channel being formed within the epicardial surface 102, together with a plurality of channel branches with a single opening having a predetermined shape extending up to the inside of the myocardium 104 and through the myocardium 104, the plurality of channel branches hanging from the opening. The method for forming the branched TMR channel comprises drilling the epicardial surface 102, either mechanically or by means of laser energy; orienting laser energy through the opening in a first predetermined angular direction with respect to the epicardial surface 102 in order to form a first channel; and transmitting the laser energy in a second predetermined angular direction in order to form the second branch.

Description

DETAILED DESCRIPTION OF THE INVENTION

[0001]

FIELD OF THE INVENTION This invention relates to a surgical procedure known as laser-assisted transmyocardial revascularization (TMR), and more particularly, to a single point above or below the epicardium, Proximal bifurcated TMR channels that extend along multiple radial, ultimately independent pathways, thereby allowing enhanced oxygenated blood, capillary trafficking of growth, healing and other factors and myocardial infusion Method and apparatus. These methods and devices may be used in surgical applications on whole humans or animals to accurately puncture, inject, angioplasty, or deliver laser energy, drugs or other therapeutic means to a predetermined location and depth. It can be applied to

[0002]

BACKGROUND OF THE INVENTION Heart disease is a common cause of death in developed countries. The leading cause of heart disease in developed countries is impaired blood supply. Atherosclerosis narrows the coronary arteries that supply blood to the heart, causing portions of the heart muscle to lose oxygen and other nutrients. The resulting ischemia or blockade inhibition may be due to angina as chest, arm or jaw pain due to lack of oxygen to the heart, or necrosis of the myocardium due to ischemia. May result in infarction. Techniques for replenishing oxygenated blood flow directly from the left ventricle into the myocardial tissue include needle acupuncture (see below) to create channels across the body cavity wall.
And there was implantation of a T-shaped tube into the myocardium.
Efforts to transplant omental, parietal pericardium or mediastinal fat to the surface of the heart have had limited success. Attempts have also been made to restore arterial blood flow by implanting the left internal mammary artery into the myocardium.

[0003] Recently, inhibition of coronary artery blockage can be treated by a number of methods. Pharmacotherapy, including nitrates, beta blockers and peripheral vasodilators (for arterial dilatation) or thrombolytics (for thrombolysis) can be very effective. Transluminal angiogenesis is often indicated-balloons are sent to the site and inflated to enlarge the opening or narrowed diameter of the artery filled with atherosclerotic plaque or other deposits can do. If pharmacotherapy is ineffective or if angiogenesis is too dangerous, a procedure known as coronary artery bypass grafting (CABG) can be indicated. This procedure requires the surgeon to make an incision below the center of the patient's chest and opening the pericardium exposes the heart. A long vein is removed from another part of the body, typically from a leg. The cut surface of the vein is first sutured to the aorta and then to the coronary artery where oxygenated blood can flow directly into the heart. CABG
Is a major surgical procedure that requires the installation of a cardiopulmonary device, and the sternum must be cut.

[0004] Another method of improving myocardial blood supply is called transmyocardial revascularization (TMR), which creates a channel from the epicardium to the endocardium of the heart. The use of needles in the form of "needle acupuncture" has been in clinical use since the 1960s. Deckelbaum, LI, Cardiovascular App
lications of Laser Technology, Lasers in Surgery and
Medicine 15 : 315-341 (1994). This procedure ischemic by allowing blood to flow directly from the ventricle through the channel, into other blood vessels perforated by the channel, or into the myocardial sinusoid, which leads to myocardial microcirculation. Was said to reduce. This procedure has been compared to turning the human heart into something similar to a reptile heart. In the reptile heart, perfusion occurs through a traffic channel between the left ventricle and the coronary arteries. Frazie
r, OH, Myocardial Revascularization with Laser-P
reliminaryFindings, Circulation , 1995; 92 [supplI
I] II-58-II-65. The growing human fetus has evidence of these traffic channels. In the human heart, myocardial microanatomy requires the presence of myocardial sinusoids. These sinusoidal traffics vary in size and structure, but constitute a network of direct connections between arteries and lumens, between arteries and arteries, between arteries and veins, and between veins and lumens. This vascular network forms an important source of myocardial blood in reptiles, but its role in humans is poorly understood.

[0005] Numerous studies have been conducted on TMR, which uses a laser to create channels in the myocardium. There is solid histological evidence that new blood vessels are formed adjacent to the collagen-occluded transmyocardial channel. In the case of myocardial needle acupuncture or perforation, which mechanically displaces or removes tissue, acute thrombosis followed by clot organization and fibrosis is the principle mechanism of channel closure. In contrast, histological evidence of a patent endothelial line inside the laser-forming channel indicates that the lumen of the laser channel is or can become haemocompatible, with thrombotic activation and And / or support the hypothesis of opposing the obstruction caused by fibrosis. The well-known thermal effect of optical radiation on valvular tissue creates a thin carbonized zone at the periphery of the laser-formed transmyocardial channel.

US Pat. No. 4,658,817, issued Apr. 21, 1987 to Hardy, discloses a T
A method and apparatus for MR are disclosed. Surgical CO
_{The two} lasers include a handpiece for directing the laser beam to a desired location. Attached to the front end of the handpiece is a hollow needle used in surgical applications, where the needle pierces a portion of the tissue to irradiate the laser beam directly to the distal tissue. June 1992 against Rudko et al.
U.S. Pat.No. 5,125,926 issued on the 30th is TM
A heart-synchronized pulsed laser system for R is disclosed. The device and method comprise a device for sensing the contraction and expansion of a beating heart. While monitoring the heart beats, the device triggers and transmits pulses of laser energy to the heart for a predetermined period of the beat cycle. The heart effect of the pulsed laser system is
This is a case where the energy and pulse repetition rate of certain types of lasers are potentially harmful to the beating heart.

US Pat. No. 5,380,316, issued Jan. 10, 1995 to Aita et al., And Feb. 1995
No. 5,389,096, issued on the 14th, discloses systems and devices for intraoperative and percutaneous myocardial revascularization, respectively. The '316 patent relates to TMR performed by inserting a portion of an elongated flexible lasing device into the patient's thoracic cavity and lasing the channel directly through the outer surface of the epicardium into the myocardium. . In the '096 patent, TMR is performed by guiding an elongated flexible lasing device into the patient's vasculature such that the firing end of the device is adjacent the endocardium. Channels are formed directly into the myocardium through the endocardium without perforation of the pericardium. TMR is most often used to treat the lower left ventricle. The lower or ventricle is supplied with blood from a more distal branch of the coronary artery. The distal coronary arteries are more susceptible to blockade inhibition and consequent myocardial damage.

[0008] To date, TMR channels have been surgically created directly into the myocardium through the epicardial surface, or they have been radially excised by a catheter directly from the endocardium inside the ventricle. Orientation is formed through the blood vessels in the pericardium layer. In each case, an essentially single-ended channel is ultimately formed. In the prior art,
Maintaining the patency of TMR channels, increasing blood flow in closed or percutaneously formed channels at the epicardium, and trauma to the epicardial layer of the heart And the need to form multiple channels from a single opening, especially in areas where access and visibility are limited.

[0009]

In the prior art, maintaining the patency of the TMR channel and the blood in a closed or percutaneously formed channel at the epicardium are known. Increased flow, reduced trauma to the epicardial layer of the heart, and the need to create multiple channels from a single opening, especially in areas with limited access and visibility It is becoming. Therefore,
Broadly, it is an object of the present invention to provide an improved method and apparatus for laser assisted transmyocardial revascularization (TMR). It is another object of the present invention to form a branched channel in the myocardium from a single access opening, thereby reducing TMR outside the heart.
It is to provide a method for implementing the method.

Another object of the present invention is to implement a TMR that forms a branched channel in the myocardium and allows blood and other factors to flow from the myocardial capillaries through the channel branch. The purpose is to provide a method. It is another object of the present invention to provide an apparatus for performing TMR in which a branched channel is formed in the myocardium. Another object of the present invention is to provide a laser delivery means having a fiber advancement mechanism and a needle directing means, which is particularly suitable for use in areas where access and visibility are limited, thereby providing a bifurcation. The present invention provides an apparatus for performing TMR in which a defined channel is formed in a myocardium from a single access aperture.

Another object of the present invention is to provide a handheld device with a fiber advancement mechanism and a laser delivery means with needle directing means to implement a TMR to form a branched channel in the myocardium. To provide an apparatus for the same. Another object of the present invention is to provide a fingertip operating device having a fiber advance mechanism and a laser transmitting means with a needle directing means,
It is an object to provide an apparatus for performing TMR in which a branched channel is formed in the myocardium.

[0012]

SUMMARY OF THE INVENTION A trans-myocardial revascularization (TMR) channel structure forming a predetermined shape extends from an opening in the epicardium of a human heart and from a first opening into the myocardium. A first molecule present and at least one additional branch extending into the myocardium, wherein the first molecule and the at least one additional branch are in communication with each other. In a preferred embodiment of the TMR channel structure, at least one of the additional branches is non-adjacent to the first branch at all points except near the aperture. Further, a preferred embodiment of the TMR channel structure comprises a cavity located between the first branch and the at least one additional branch and communicating with those branches. Further, a preferred embodiment of the TMR channel structure comprises at least two additional branches extending from the first opening into the myocardium, thereby forming a plurality of traffic TMR channels in a given portion of the myocardium. . Further, the preferred embodiment of the TMR channel structure has at least one branch of the TMR channel that is arcuate in shape. Further, a preferred embodiment of the TMR channel structure has at least one branch of the TMR channel extending through the epicardium.

[0013] A method of forming a branched transmyocardial revascularization (TMR) channel in a predetermined portion of the myocardium comprises the steps of: (a) forming an opening in the epicardial layer of the ventricle;
Transmitting a first amount of laser energy through the aperture at an angle to the epicardial surface such that a bifurcation of the laser beam is formed in the myocardium; and (c) one or more points. First
A second amount of laser energy is passed through the aperture to a first predetermined angle with respect to the epicardial surface such that a second branch is formed in the myocardium in communication with the bifurcation. Transmitting at a different, second predetermined angle, thereby forming a close, branched TMR channel. In a preferred embodiment of the method, step (a) further comprises transmitting a sufficient amount of laser energy to the epicardial surface to form at least one through hole. A preferred embodiment of the method further comprises transmitting a sufficient amount of laser energy to the at least one branch to penetrate the endocardium. A preferred embodiment of the method further comprises: (d) applying an additional amount of laser energy through the aperture to the epicardium layer to form a plurality of branches in the myocardium. Transmitting at a predetermined angle, thereby forming a plurality of branches of the TMR channel which are communicating with each other, and forming a close branch TMR channel.

[0014] Proximal bifurcated myocardial revascularization (TM
R) A method of forming a channel in a predetermined portion of the myocardium comprises:
(A) forming an opening in the epicardium by mechanical perforation; (b) inserting a hollow guide needle into the opening; and (c) first branching the TMR channel into the myocardium. Transmitting a first amount of laser energy through the hollow guide needle at an angle to the epicardial surface as determined by the angular orientation of the hollow guide needle, as formed therein; (D) A second hollow guide needle is inserted inside the opening on the epicardial surface.
(E) passing a second amount of laser energy through the hollow guide needle so that a second branch of the TMR channel is formed in the myocardium. Transmitting at a second predetermined angle as determined by the second angular direction. A preferred embodiment of the method comprises the steps of: (f) transmitting the second amount of laser energy through the hollow guide needle at a second predetermined angle to the distal end of the laser transmitting means. Comprising the additional step of retracting the laser transmission means so that it does not extend beyond the opening at the distal end of the laser. In a preferred embodiment of the invention, at least one branch of the TMR channel extends through the endocardium.

[0015] A guide block device for a surgical transmyocardial revascularization (TMR) procedure comprises a body for placement over the epicardium of the heart, the body comprising upper and lower surfaces, and upper and lower surfaces. Forming an opening disposed between the surfaces and a centering means surrounding the opening and extending through the body from the opening and angling the laser transmitting means to form a proximally branched TMR channel; And a supporting surface. In a preferred embodiment, the guide block device further comprises a guide needle having a proximal end, a central axis, and a distal end that is sharpened to mechanically pierce the epicardial surface. A hollow guide needle directs the laser transmission means to transmit laser energy to a predetermined portion of the myocardium. A housing having an upper surface and a lower surface, wherein a rotation guide device for forming a bifurcated transmyocardial revascularization (TMR) channel is positionable on an epicardial surface adjacent a predetermined portion of the myocardium; Rotating head means disposed within the housing and operatively coupled to the rotating head means, the central axis, the proximal end, and the distal end being sharpened to mechanically pierce the epicardial surface. A hollow guide needle means having an end, the first extending into the myocardium.
To transmit laser energy through the hollow guide needle means and the epicardial surface to a predetermined portion of the myocardium at a first predetermined angle relative to the epicardial surface such that a bifurcation is formed. The hollow guide needle means directs the laser transmission means, the laser transmission means is retractable through the hollow guide needle means, and transfers the laser energy to the hollow guide needle means and the epicardium so that a second branch is formed. The hollow guide needle means is rotatable for transmitting through the membrane surface to a predetermined portion of the myocardium at a second predetermined angle with respect to the epicardial surface, the first branch and the second branch. Is combined with the adjacent branched TMR
Form a channel. In a preferred embodiment,
The guide needle means of the rotating guide device further comprises a curvature of the distal end to deflect the distal end of the laser transmission device by an angle with respect to the central axis of the hollow guide needle device. In a preferred embodiment, the distal end of the guide needle is a predetermined number of times to enable the laser transmitting means to transmit laser energy into the myocardium at a predetermined angle to the epicardium. A predetermined number of angular positions are provided on the rotary head of the rotation guide device so as to be directed to the angular positions. In a preferred embodiment, the rotation guiding device further comprises a handle mounted on the housing. In a preferred embodiment, the rotation guide device further comprises a stabilizing means for forming a safe anchor point between the device and the epicardial surface. In a preferred embodiment, the stabilizing means is integrated with the housing part,
Thereby, a flexible bellows portion forming an evacuable chamber extending slightly below the housing portion when positioned adjacent the epicardial layer, and a rotation guide device adjacent the epicardial layer. It is in communication with a vacuum supply so that the evacuable chamber can be evacuated when placed, from a vacuum port that supplies a vacuum seal between the rotary guide and the epicardial layer. Become. In a preferred embodiment, the stabilizing means of the rotary guide further comprises a guide needle means. In a preferred embodiment,
The rotation guide further includes a laser transmission means advancing mechanism mounted inside the handle. In a preferred embodiment, the rotation guide device laser transmission hand comprises a laser transmission means holding means and an actuator, the laser transmission means holding means holding the laser transmission means in a safe position inside the handle, and the actuator transmitting the laser transmission means. The means is advanced and retracted a predetermined distance through the handle. In a preferred embodiment, the rotation guide device laser transmission means advancing mechanism comprises a motor for advancing the laser transmission device a predetermined distance. In a preferred embodiment, the rotary guide rotary head means comprises a worm gear assembly. In a preferred embodiment, the rotating guide handle portion is elongated in the form of a hand wand for the convenience of manual control, and the elongated handle is a distal end from which the laser transmission means can be inserted into the handle portion. The handpiece has an end and further comprises a manifold for guiding the laser transmission means from the handle portion to the head device and further into the hollow tubular opening of the guide needle means.

A guide needle for forming a bifurcated TMR channel comprises a hollow tubular body terminating at a distal tip which is curved to deflect a fiber optic laser transmission means mounted therein. Numerous other advantages and features of the present invention will be readily apparent from the following detailed description of the invention and its embodiments, the appended claims, and the accompanying drawings.

[0017]

DETAILED DESCRIPTION OF THE INVENTION As noted above, TMR is a method of forming holes, channels or small tunnels in and through the myocardium and portions of the epicardial and / or endocardial surfaces. It is. The present invention is for use with medical lasers. In particular, holmium lasers are particularly suitable for the present invention. However, any suitable laser source, whether pulsed or not, can supply laser energy to the laser delivery means of the present invention for implementing the method of the present invention. Similarly, catheters and surgical instruments, including laser delivery means, referred to herein and known and used in medicine and other fields now and in the future, are also within the scope of this disclosure. become. Such laser transmission means include, but are not limited to, individual optical fibers as well as fiber bundles, rods, mirrors, and other laser transmission means are well described and practice of the method of the present invention. It would be useful in that case. The preferred method of the present invention uses not only the new and unique apparatus described herein, but also conventional mechanisms that allow the tip of the optical fiber to be angled or rotated to form a branched channel. It will also be understood that this is implemented. Preferred Channel Shape Prior art channels are generally single, straight paths. The nearby divergent channel of the present invention is a traffic channel. The traffic channel may be straight, curved in one or the other direction, and may have internal corners of essentially any radius of curvature. Of course, the effectiveness,
The time required to perform the procedure, the complexity of the equipment required,
From the point of view of the surgeon's skill level, etc., a channel with a specific shape is more effective, but in fact, a channel with almost any shape can be formed in the heart. Although the channels described herein and methods for forming them are envisioned to start from or just below the epicardial surface, the channels terminate at some point within the myocardium, It will be understood that the channels generally continue through the myocardium and endocardium, despite being able to provide a "stimulus". Unless the specific limiting language clearly dictates otherwise, all such "channel" embodiments will be encompassed herein and the envisaged hole or channel will largely be Penetrate both the pericardial layer and the endocardium.

FIGS. 1, 2, 3, 4, 5, 6, 7, 8 and 9 are cross-sectional views of a channel through the pericardial layer embodying the principles of the present invention. It is the displayed channel shape diagram. FIG. 1 shows a conventional channel 100.
The channels extend into the myocardium 104 essentially along a direction or axis A perpendicular to the epicardial surface 102 of the heart. In FIG. 2, the "2D inverted Y" channel has one opening 110 in the epicardial surface. The channels are symmetric and are easily adaptable to 3D shapes. For example, extending the central branch 114 just below the junction 112 can create a large cavity at the junction, which gives the channel a relatively large void volume,
Eliminating sharp edges would increase the potential for enhancing once-through blood circulation. Furthermore, due to hydrodynamics, if the cavity becomes larger or the angle of the corner becomes smaller, from the inside of the ventricle, through the endocardium, along the channel through the first and second branches. The pressure drop of the flowing blood is small. Thus, the term "cavity" includes the entire area between the opening in the epicardial surface and the bottom of the central branch, including the junction of the central branch and two or more branches depending therefrom. It will be understood that.
In FIG. 3, the channel that is branched into a "curved inverted Y" also has a single opening in the epicardial surface 120 so that it can be symmetrical and adapted to a 3D shape. In addition, a larger cavity 122 can be provided near the junction of the main channel, thereby reducing the risk of thermal damage in the junction area.

It will be appreciated that the depth of penetration of the initial channel beneath the epicardial surface can be varied by the surgeon or by operating options of the device of the present invention. The initial portion of the channel can be very short so that the junction of the sagging branches is closer to the epicardial surface or deeper inside the myocardium. The provision of the depth stop means allows the operator to adjust the penetration depth of the guide needle or the laser transmission device. Such a depth stop means controls not only the distance over which the guide needle or the puncture needle can be advanced, but also the distance over which the laser transmission device can be advanced. Of course, as will become apparent, the degree of rotation of the guide needle or other piercing means is infinite,
Or it can be adjusted by a fixed preset indexed stop or indent.

The following table lists the names of various channel shapes. It will be understood that these names are for description of a particular embodiment and, therefore, are in no way limiting. ───────────────── Figure Preferred channel shape １ 1 Straight or conventional ─────── ────────── 2 2D inverted Y shape ───────────────── 3 2D curved inverted Y shape 字───── 4 2D or 3D inverted V-shape 5 3D squid ───────────────── 6 2D twig shape ───────────────── 7 3D twig shape ８ 8 3D curved inverted Y shape ── ９ 9 2D or 3D capillary channels 際 When forming multiple channels with multiple branches An important point to consider is the overall rise in temperature of surrounding tissue. You. Indeed, although it is possible to actually laze a large number of branches, all at different angles with respect to the axis perpendicular to the surface of origin, the heat created is particularly limited by cavities or individual perforations or lasing channels. In the area of the junction, the tissue surrounding the channel may be damaged. By increasing the delay between drilling of individual channels,
Of course, the excess heat will be extinguished.

Another point to consider is the direction of blood flow inside the heart and coronary arteries, and the placement of channels. At least at various stages of the cardiac cycle,
Because there is blood flow through the heart and coronary arteries, pressure gradients can be found throughout the heart and individual ventricles. By providing a channel in the endocardium having a plurality of openings aligned with or oriented in the direction of blood flow, blood flow through the patient's channel is increased. It will be appreciated that the preferred embodiment of the present invention is particularly suitable for open heart surgery as well as for the more recently preferred minimally invasive surgery (MIS) technique. In MIS procedures, one goal is to reduce the size of the opening in the thoracic cavity, so the device allows for maximum control while minimizing the size of the access path to the heart. Appropriate design must be done to become.

FIGS. 10 (A), (B), (C) and (D)
1 is a diagram of a preferred embodiment of an apparatus and method using the present invention to use a needle for the purpose of perforating the myocardium. In FIG. 10 (A), the needle 150 is optionally moved through a guide block 154, a mandrel or other safety means.
It has been inserted through the epicardial surface 152. The curved needle has an opening 156 that can be oriented in a predetermined direction relative to the myocardium 158 to be angioplasty. In FIG. 10B, a laser delivery means 160, such as a fiber or fiber bundle, has been inserted through the lumen of the needle. The curvature starting from the distal tip of the needle is maintained by the optical fiber or fiber bundle, resulting in the formation of a first curved channel 164 along a first axis B that forms an angle C with the normal to the epicardial surface. Is done. As shown in FIG. 10C, the laser delivery device is retracted into the needle and the needle is rotated so that the aperture is directed away from the first branch and the second curve The laser delivery device is again advanced to form channel 170. FIG. 10 (D)
In, both the laser delivery means and the needle have been removed, leaving a branched channel 172 formed. The method of forming the channel can be modified according to surgeon preference, but generally consists of a combination of fiber advancement and laser transmission. It will be appreciated that by directing one or two extra pulses of laser energy to the junction of the branches, a cavity below the epicardial surface can be created. This cavity will increase the patency of the channel and the ability of blood to flow through. In addition, a single optical fiber or fiber bundle can be used, and the fiber or fiber bundle preferably includes a biasing member to increase flexibility to help pass through the curved needle It will be appreciated. The biasing member may include, for example, a piece of nitrol or other malleable or memory wire inside the fiber bundle, or may include a piece of heat-treated plastic material around the fiber bundle preset in an arc. it can. Pre-curved needles also reduce friction as the fiber is advanced and improve the feel. Rotary Guide Needles FIGS. 11, 12, 13 and 14 are cross-sectional and light isometric views of a guide needle used in a preferred embodiment of the apparatus and method of the present invention. FIG. 11 is a cross-sectional view of a needle with a straight cut end opening 200 opposite the distal tip curve 202. FIG. 12 is a light isometric view of the same embodiment. FIG.
Is a cross-sectional view of the needle with the conical cut end opening 204 opposite the curve 206. FIG. FIG. 14 is a light isometric view of the same embodiment. The distal end of the needle is formed as the end where the laser delivery device begins to stretch to form a channel in the myocardium, deflecting the conical or flat cut piercing point and the distal end of the laser delivery device It will be understood that the curve comprises It will be appreciated that the proximal end of the guide needle is the end where the laser delivery device enters the guide needle. Typically, the needle is cut from a suitable holding material or otherwise manufactured. The radius of the end that deflects the laser transmission means at an angle can also be formed by wrapping the material around a 3/8 or 1/2 inch mandrel or other form. In general, the angle D formed between the straight cut end face and the needle axis, and the formed angle E between the conical cut end face and the needle axis, in a preferred embodiment, is about 3 to 10 °. The conical cut tip initially forms a flat cut tip, then bends the end of the needle using a mandrel, rotates the needle about its center axis, and forms an arcuate surface 208 having a radius of curvature F. By turning the end cut surface by the radius of curvature. The formation of this conical cut tip can be made with a dramel tool or other mill, lathe, or the like. The internal shoulder of the needle opening near the laser transmission means is sufficiently rounded or otherwise smoothed so that the fiber or fiber bundle is not damaged or wrapped during insertion or removal. It will be understood that Another method of forming an efficient piercing tip is to bend the tip of the needle, rotate the needle about an axis slightly offset from the center axis of the needle by about 6-8 °, and then apply the conical surface This is to polish the end cut surface. This results in a more durable and efficient perforation needle tip. In a preferred embodiment, the theoretical fiber optic deflection by the needle tip is about a factor, since the outer diameter of the optical fiber or fiber bundle must be smaller than the inner diameter of the needle tip for efficient stretching and retraction. 25-30 °, and therefore the actual bending of the resulting laser transmission device is smaller.

In a preferred embodiment, the guide needle of the present invention provides a needle tip when piercing the epicardial surface to reduce or eliminate bleeding by cauterizing the tissue opening of the punctured channel. Has a heating means so as to become hot. Thereafter, when the laser delivery means is advanced through the needle and used to laze the channel into the myocardium, excessive bleeding will not obstruct the view of the area. The heater means may also include a small resistance heater to heat the needle tip by passing an electric current. Another embodiment is an absorbing element, such as a stainless steel tip, preferably at or near the optical fiber deflection curve, such that a portion of the transmitted laser energy is absorbed to sufficiently heat the tip. Is used for the needle. Other heater means will be known to those skilled in the art. Centering Guide Block FIGS. 15A, 15B, 15C and 15D are illustrations of a centering guide block and a method of using the preferred embodiment of the present invention. The guide block 220 is placed over the epicardium and advanced until the needle 222 pierces the epicardial surface 224. The guide block has a frustoconical inner support surface 226. When tilted to one side, as shown in FIG. 15 (B), the needle and optical fiber mounted inside are leaned against the support surface, and the angle with respect to the perpendicular to the epicardium in the direction G of H Enters the myocardium 228 downward. In this embodiment, a needle that does not deflect the transmission end of the laser transmission means can be used. Fig. 15
In (C), the optical fiber 229 or other transmission device is in a retracted state and is tilted in another direction deflected with respect to the support surface. In this position, the optical fiber can be advanced again to form a second channel in the direction of J with respect to the first branch 230. The result is a multi-branched channel 232 that begins just below the epicardial surface. This "centering" concept can be used with the rotating needle device described below to form a two-dimensional or three-dimensional branch channel. Alternatively, a guide block can be used as a support for the laser drilling device, in which case the laser tip is formed so that the block forms a dual channel by acting as a flexure or swivel joint. Rotated.

FIG. 16 is a cross-sectional view of a guide block with flexible joint tips and bellows for vacuum assisted stabilization of the device. The guide block has a housing portion 290 having a flexible bellows 292 extending downwardly and outwardly from the outer periphery thereof. Above the guide block is a flex joint 293. This joint, e.g., a ball joint, provides laser delivery at an angle for access to areas where the laser delivery device cannot be placed upright prior to formation of a channel through the myocardium. It is possible to arrange means. Bellow thin section 294 is made of rubber or other flexible material. A bellowed guide block is placed over the epicardial surface 295. In a preferred embodiment, when a vacuum is applied to the interior of the bellows through the vacuum port 298, the thin portion of the bellows collapses, maintaining the bellows securely attached to the epicardial surface. A flex joint tip 300 is provided at the distal end of the laser transmission path. An optical fiber 302, fiber bundle or other laser delivery means can be extended from the flexure joint tip and used to lasing the branch of the channel into the myocardium. Such a vacuum assisted device and procedure is described more fully in US Ser. No. 08 / 628,849, filed Apr. 5, 1996.

Based on the above description of the rotary guide block and the pivot guide block, the guide block with bellows reorients the flexure joint tip to form a second branch of the original channel. It will be appreciated that it may have internal rotating parts or other means. Further, when a vacuum force is applied, the guide needle is lasered so that the collapsing bellows penetrates the tip of the guide needle through the epicardial surface at a predetermined angle to the epicardial surface and other channels. It can also be located at the distal end of the means. Bellows with suction accessories to hold the laser delivery device (or guide block or pivot block or other rotating means) provide a single stabilization for mounting the device in place on the heart during the lasing procedure of the individual channels It will be understood that it is a device. As the heart beats, the suction device or other stabilizer means helps the surgeon offset the heartbeat of the heart. The individual clinician may be advised that the ballast means will place the device exactly adjacent to a particular site on the epicardium and that open heart surgery may be otherwise difficult to maintain its position during the procedure Conversely, one may find it particularly beneficial in minimally invasive surgical procedures. The ballast means will also include an external retractor or clamp-type feature to allow the target mass to be held in place, but allow the mass or most of the heart to move freely.

FIG. 17 is a cross-sectional view of a guide block with flexible joints and bellows for vacuum assisted stabilization of the device. In this embodiment, flexible joint 303 is located inside flexible bellows 304. In this alternative embodiment, the flexible joint for rotating the handle is located closer to the heart surface and the flexible tip is omitted. Needle 305 or guide tube is epicardial 30
6 to a position just above. In this manner, the laser delivery means, such as an optical fiber, approaches the epicardium and has a predetermined angular range L
The epicardium can be pierced at an angle within. Rotating Needle TMR Handpiece FIGS. 18, 19, 20, 21, 22, and 23 illustrate a preferred embodiment of the rotating needle TMR handpiece of the present invention used to facilitate the formation of a traffic channel. FIG. FIG. 18 illustrates how to use the handpiece of the present invention. The handpiece 310 can be held by the surgeon with one hand. An opening is formed in the thoracic cavity by conventional means, and the head 312 is positioned at the desired location above the heart 314. The head serves the purpose of a guide block in that the head can be positioned and attached to the heart with or without a vacuum. The head may include a guide needle. A thumbwheel 316 is used by the surgeon to advance an optical fiber or fiber bundle into the channel being formed.
A preferred embodiment further comprises the following internal rotation holder that rotates after the optical fiber is advanced, the channel is formed, and the optical fiber and / or the needle is retracted.

FIG. 19 is an isometric view of a preferred rotary needle handpiece of the present invention. Handpiece is handle part 320
And 322 tails. A thumbwheel 316 is used to advance an optical fiber, fiber bundle or other laser delivery means. A neck portion 324 is coupled to the handle portion and may include a pivot joint 326. As the optical fiber extends from the tail, through the handle, and into the neck, the optical fiber is inserted into the manifold 328 to make the necessary change in direction to guide the optical fiber or fiber bundle from the head. Be guided.
It will be appreciated that the manifold structure can be manufactured in one piece with the neck and head, for example by extrusion or injection molding methods. Such a J-grip TMR device is described more fully in US Ser. No. 08 / 607,782, filed Feb. 27, 1996. Fig. 20
FIG. 4 is an isometric view of a preferred rotating needle handpiece of the present invention with optical fiber depth adjustment means. As in the previously disclosed embodiments, a thumbwheel 330 is used to advance a laser delivery device, such as an optical fiber, through the handpiece. The advancing distance of the optical fiber is controlled by the depth adjusting means 332 of the slider type on the side of the laser transmitting means. The maximum depth of the channel to be formed by the handpiece can be precisely and easily set by placing the side slider at the appropriate axial position as indicated by graduations or other reference means 334. In a preferred embodiment, a slider mechanism controls the depth at which the optical fiber can be advanced, visually displays, and adjusts the depth stop control. It will be appreciated that the handpiece can have a one-sided or two-sided slider depth adjustment means. Further, other means for adjusting the advancement depth of an optical fiber or other laser transmitting means through the handpiece will be apparent to those skilled in the art.

FIG. 21 is a side view of the preferred rotary needle handpiece of the present invention, and FIG. 22 is a plan cross-sectional view of the preferred rotary needle handpiece of the present invention taken along section 20. Optical fiber 338 or other laser delivery means is at the proximal end of the device
It will be understood that it enters through 340, passes through guide tube 342, and emerges from guide needle 344 at the distal end of the device. In the preferred embodiment, a small battery 346 mounted in a battery cradle 348 and operated by a microswitch 350 is mounted on a circuit board 35.
2 and the needle rotation motor 354. Thumbwheel
By manual operation of 356, the optical fiber or other laser transmitting means coupled to rack portion 358 advances and retracts-the individual gears of the thumbwheel engage the geared rack portion. Alternatively, the advancement of the optical fiber can be automated using a motor. The proximally located bulkhead 360 is used to mount the internally located fiber optic advancement and head rotation mechanisms into the TMR handpiece or wand.
And a distal placement septum 362 is used. In a preferred embodiment, the head of the TMR wand is positioned over the myocardium such that the guide needle pierces the intended channel site in the epicardium. As the laser delivery optical fiber is advanced using the thumbwheel, the channel is lazed into the myocardium. The thumbwheel is moved in the direction indicated by the double arrow K. The thumbwheel portion can be manufactured to advance the optical fiber directly without a drive reduction gear, or to utilize a conventional gear reduction to advance the optical fiber according to a predetermined degree of angular rotation. It will be understood that it is possible. In an automated embodiment, the thumbwheel is an electrical actuator with contacts that complete an electrical circuit for moving the optical fiber in a desired direction. The precise relationship between the degree of longitudinal movement and the degree of angular rotation can be selected as desired by precision techniques well known to those skilled in the art. Once the first branch of the channel is formed, the thumbwheel will be used to retract the optical fiber.
Thereafter, the direction of the guide needle can be determined again. In response to the movement of the thumbwheel to its most retracted position, the control needle can rotate the guide needle, in which case the needle rotation motor is in the circuit with the thumbball. Alternatively, a separate switch can be mounted on the handle or other part of the TMR wand to control the angular rotation of the TMR head and guide needle. In the preferred embodiment, the guide needle rotation motor is coupled to gear head 364. A shaft 366 extends through the neck of the handpiece from the gear head to the rotating section 368.

FIG. 23 is a detailed front sectional view of the rotary needle handpiece of the present invention with respect to section 21. As mentioned above, the device comprises both a fiber optic advancement mechanism and a guide needle rotating means, optionally in various embodiments, and preferably, including associated electronics, sensors, stop devices, actuators, power supplies, etc. Have. Needle holder 370 is integral with pinion gear 372 which is actuated by worm gear 374. When the worm gear is advanced in the direction L, the pinion gear 372 rotates together with the needle holder 370 and the needle 344 in the direction M. as mentioned above,
The preferred embodiment has an automatic needle rotation and angle extension synchronization electronics system so that the thumbwheel consists of an actuator and a sensor for detecting the advance length of the optical fiber. The controller rotates the needle by a predetermined angle.

FIG. 24 is a block diagram of an electronic device of the rotary needle handpiece of the present invention. For display purposes, an optical fiber or fiber bundle 600 is shown attached to an optical fiber advancement mechanism 602 in a forward position.
The switch can also be moved to the rear position 604. Before the mechanical or other linkage of the fiber optic advancement mechanism reaches the mechanical depth stop 610, the sensor
Block 606 so that the user issues an audible alarm 614.
Has been adjusted. This audible alert informs the surgeon about the penetration depth of the optical fiber in order to make the penetration depth and accuracy of channel formation uniform throughout the procedure. The alarm can be a visual or sensory alarm, or can be integrated with other intelligent jet controls. Related control electronics are the controller 61
Consists of six. The controller includes a printed circuit board,
A pre-programmed, programmable or semi-programmable microcontroller and other inputs or outputs;
And other related electronic devices. A power supply 618, such as a battery, is attached to the controller and powers the alarm and miniature DC motor 620. The miniature motor toggles in forward and reverse directions in response to signals generated by the motor start and toggle direction select switch 622. This switch is activated when the depth adjustment mechanism is in the rearward position. The preferred embodiment uses a small motor rotation indicator LED 624, or other visual, sensory or audible indicator. The switches of the device are mechanical, Hall effect, optical or other, and the motor current and voltage are predetermined or variable. Various types of alerts will be known to those skilled in the art, including small lights, audible alerts, vibrating components, diodes, other electronic means, and the like. Although the preferred embodiment includes mechanical linkages, it will be appreciated that these mechanical components could be replaced by electronic or other systems for fiber optic advancement and needle rotation. . To let you know the rotation of the needle,
Additional audible alerts may be provided at different frequencies.

Various embodiments for rotating the needle in a rotary drive will be known to those skilled in the art. For example,
Any mechanical head rotation means, such as a rack and pinion assembly, a worm gear, an actuator rod, a torsion spring, etc., would be applicable to the present invention. Fingertip operation TMR device FIG. 25, FIG. 26, FIG. 27, FIG. 28, FIG.
FIG. 3 is an illustration of a preferred embodiment of the rotary drive of the present invention designed to be held by one finger, with the remaining fingers and devices used to approach the inaccessible posterior side of the heart. In some cases, it acts as a heart retractor. FIG. 25 is a plan perspective view of the fingertip operation TMR device. The optical fiber 500 can be fed into and through the device, particularly from the horn 502 for TMR, the other side of the heart, other handles or support means, or directly from the opening 504 in the upper portion 506 of the device. The aperture 504 is particularly beneficial for high access sites, allowing for a straight advance of the optical fiber, thereby reducing drag. In another embodiment of the invention, the TMR device is held by one hand and the laser transmission means is inserted through the TMR device by the opposite hand or assistant. The hand used for insertion activates a laser advance mechanism trigger, such as a thumbball 508. The manual feed system also uses a fingertip operated button 510 to rotate the needle. The low profile of the rotating handpiece is a key point for use in confined spaces. FIG. 26 is a plan perspective view of the wrist holding fingertip operation TMR device. While the fingertip is used in the above manner to control the push button, the device
A strap portion 520 is used for stabilization and to keep the remaining fingers free to retract the heart for access to the posterior wall.

FIGS. 27, 28 and 29 are top, bottom and exploded isometric views of two preferred embodiments of the fingertip operated TMR device of the present invention. FIGS. 28 and 29 show a suitable lightweight autoclavable or otherwise sterilizable having a suitable surface texture that allows the surgeon to grasp the device during a procedure in the presence of blood or other liquids A housing 530 or other protective cover made from various materials is shown. A horn 532 or other hollow opening or extension serves as a first path for feeding the optical fiber through the insertion port 533 and penetrating through the device. An optical fiber or other laser transmitting means can also be inserted into the device from the conical section 534 at the top of the housing. The conical portion has a small hole inside through which the optical fiber can be advanced. In a preferred embodiment, the conical portion has a flange 53 which serves to hold the device securely in the surgeon's hand when the surgeon's finger slides between the housing and the flange.
Contains 6 A fingertip control push button 540 is mounted inside the housing and includes a rack 542 and a spring 544.
Engage with. When desired, pressing the push button causes the two pins 54 extending through slot 548 to be
The rack, held in place above 6, is moved axially. The teeth of the rack engage a reduction gear 550 mounted on pins 556. Reduction gear teeth are pinion gears 5
Engage with 52. The stationary rotary head 554 is pressed against or otherwise against a pinion gear and rotates synchronously with the gear assembly and guide needle 557 held therein. The rotating head rests on the center 558 of the chassis section 559 of the device. It will be appreciated that the chassis portion serves primarily to maintain the integrity of the assembly as needed. The maximum dimensions of the preferred embodiment of the present invention are about 3 inches in diameter, about 41/2 inches in length to the end of the horn, and only 1 inch high, but do not include a slightly extended needle. . A first opening 560 through the hollow tubular portion 562 of the horn or other handle serves as a path for advancing the optical fiber through the device.

The preferred single-entry embodiment shown in FIG. 27 also employs a finger or thumb-actuated needle rotation button or bar 510 mounted in the lower portion 664 of the housing 530 to provide the posterior surface of the heart. It is particularly suitable for minimally invasive surgical (MIS) procedures such as TMR from US. Such posterior or lateral treatment is described in more detail in US Ser. No. 08 / 627,704, filed Mar. 29, 1996. Transparent or translucent tube 650 with graduated markings 652
Extend from the top. In a preferred embodiment, the tube is twisted to form an open side port.
The device is held between the index and middle fingers, and the remaining fingers of the same hand can be used for retracting and stabilizing. A depth stop 654 is attached to the optical fiber or fiber bundle 500, such as a threaded clamp mechanism above the fiber so that the maximum penetration depth of the laser transmission means can be controlled. It can be adjusted by various positioning means. The depth stop is located at a predetermined position on the optical fiber. In addition, with detents such as one-piece beads or other fixed components,
The optical fiber is prevented from being completely retracted from the device. Graded markings on the flexible or semi-flexible tube serve to provide the surgeon with a visual indication of the penetration depth during channel formation. Lower housing without limitations caused by the surgeon's predetermined orientation of the laser delivery device
So that the 664 can be positioned efficiently
660 pivots around joint 662. The rotatable needle is retractable, and scallop can be provided in the housing and on the button for ease of gripping and other design purposes. further,
The lower surface of the TMR device can also be made of a non-slip material such as textured metal or rubber, and have dimples or embossments on it to facilitate safe placement of the device during operation It will be understood that it can also be.

FIG. 30 is an alternative exploded view of the gear box of the needle rotating mechanism of the fingertip operation TMR device of the present invention. Gear retainer 700
House a plurality of gears 702 that rotate about a plurality of shafts 704. Button 706 is located inside button holder 708 so as to lean against rack gear 710. The mechanical stop element 712 also serves as a spring screw retainer. Set screw 714 and spring tension adjusting screw 71
6 acts on the mechanical stop element and the spring 720. A plurality of fasteners 718 hold the assembly. Various embodiments for achieving rotation of the needle in the rotary drive will be known to those skilled in the art. For example, any mechanical head rotating means such as a rack and pinion assembly, a worm gear, an actuator rod, a torsion spring and the like are applicable to the present invention.

In any of the embodiments described herein where the laser delivery means follows the guide needle or other piercing means, the provision of a rotary interlock system is an optional feature. Such an interlock system is
Prevent the needle from rotating before the optical fiber is retracted or otherwise removed from the aperture.
This interlock reliably prevents the guide needle from rotating while the laser transmission means is not at least housed within the guide needle shaft. While the principles of the invention have been illustrated by illustrated embodiments, the structures, arrangements, proportions, elements, materials and components used in the practice of the invention may be modified without departing from these principles without departing from the spirit and scope of the invention. It will be readily apparent to those skilled in the art that many modifications are possible which are particularly suited to the conditions. It is intended that the appended claims cover the full scope of all such changes, with limitations limited to the true spirit and scope of the invention.

[Brief description of the drawings]

FIG. 1 is a channel shape diagram showing a cross-sectional view of a channel through a pericardial layer embodying the principles of the present invention.

FIG. 2 is a channel shape diagram showing a cross-sectional view of a channel through the pericardium layer embodying the principles of the present invention.

FIG. 3 is a channel shape diagram showing a cross-sectional view of a channel through the pericardium layer embodying the principles of the present invention.

FIG. 4 is a channel shape diagram showing a cross-sectional view of a channel through the pericardium layer embodying the principles of the present invention.

FIG. 5 is a channel shape diagram showing a cross-sectional view of a channel through the pericardium layer embodying the principles of the present invention.

FIG. 6 is a channel shape diagram showing a cross-sectional view of a channel through the pericardium layer embodying the principles of the present invention.

FIG. 7 is a channel shape diagram showing a cross-sectional view of a channel through the pericardium layer embodying the principles of the present invention.

FIG. 8 is a channel shape diagram showing a cross-sectional view of a channel through the pericardium layer embodying the principles of the present invention.

FIG. 9 is a channel shape diagram showing a cross-sectional view of a channel through the pericardium layer embodying the principles of the present invention.

FIG. 10A is a diagram of a preferred embodiment of an apparatus and method using the present invention. (B) is a diagram of a preferred embodiment of an apparatus and method using the present invention. (C) is a diagram of a preferred embodiment of an apparatus and method using the present invention. (D) Preferred embodiment of an apparatus and method using the present invention.

FIG. 11 is a cross-sectional and light isometric view of a guide needle used in a preferred embodiment of the apparatus and method of the present invention.

FIG. 12 is a cross-sectional view and a light isometric view of a guide needle used in a preferred embodiment of the apparatus and method of the present invention.

FIG. 13 is a cross-sectional view and a light isometric view of a guide needle used in a preferred embodiment of the apparatus and method of the present invention.

FIG. 14 is a cross-sectional and light isometric view of a guide needle used in a preferred embodiment of the apparatus and method of the present invention.

FIG. 15A is an illustration of a method of using a preferred embodiment of the present invention. (B) Schematic illustration of the method of using the preferred embodiment of the present invention. (C) An illustration of a centering and flexing joint guide block device and method of using a preferred embodiment of the present invention. (D) Schematic illustration of a method for using the preferred embodiment of the present invention.

FIG. 16 is an illustration of a pivot and flex joint guide block device and method of using a preferred embodiment of the present invention.

FIG. 17 is an illustration of a pivot and flex joint guide block device and method of using a preferred embodiment of the present invention.

FIG. 18 is a diagram of a preferred embodiment of the rotating needle TMR handpiece of the present invention used to facilitate the formation of a traffic channel.

FIG. 19 is an illustration of a preferred embodiment of the rotating needle TMR handpiece of the present invention used to facilitate the formation of a traffic channel.

FIG. 20 is a diagram of a preferred embodiment of the rotating needle TMR handpiece of the present invention used to facilitate the formation of a traffic channel.

FIG. 21 is a diagram of a preferred embodiment of the rotating needle TMR handpiece of the present invention used to facilitate the formation of a traffic channel.

FIG. 22 is a diagram of a preferred embodiment of the rotating needle TMR handpiece of the present invention used to facilitate the formation of a traffic channel.

FIG. 23 is a diagram of a preferred embodiment of the rotating needle TMR handpiece of the present invention used to facilitate the formation of a traffic channel.

FIG. 24 is an electronic device block diagram of the rotary needle handpiece of the present invention.

FIG. 25 is an illustration of a preferred embodiment of the rotary drive device of the present invention.

FIG. 26 is an illustration of a preferred embodiment of the rotary drive device of the present invention.

FIG. 27 is an illustration of a preferred embodiment of the rotary drive device of the present invention.

FIG. 28 is an illustration of a preferred embodiment of the rotary drive device of the present invention.

FIG. 29 is an illustration of a preferred embodiment of the rotary drive device of the present invention.

FIG. 30 is an illustration of a preferred embodiment of the rotary drive device of the present invention.

Continued on the front page (72) Inventor Stuart Dee Harman United States of America 94089 Sunnyvale Keel Court 1049 (72) Inventor Robert El Lathrop Jr. United States of America 95128 San Jose South Winchester Boulevard 1101 (72) Inventor Bruce Jay Richardson United States of America California 95128 San Jose South Winchester Boulevard 1101

Claims (28)

[Claims] 1. A trans-myocardial revascularization (TMR) channel forming a predetermined shape, comprising: an opening in the epicardium of a human heart; and a first extending from the first opening into the myocardium. A transmyocardial revascularization (TMR) channel, comprising: a branch; and an additional branch into at least one myocardium in communication with the first branch. 2. The TMR channel of claim 1, wherein at least one of the additional branches is non-adjacent to the first branch at all points except near the aperture. 3. The TM according to claim 1, further comprising a cavity located between the first branch and the at least one additional branch and communicating with those branches.
R channel. 4. The method of claim 1, further comprising at least two additional branches extending from the first opening into the myocardium, thereby forming a plurality of traffic TMR channels in a predetermined portion of the myocardium. The TMR channel according to claim 1. 5. The TMR channel according to claim 1, wherein the shape of at least one branch of the TMR channel is arcuate. 6. The TMR channel of claim 1, wherein at least one branch of the TMR channel extends through the epicardium. 7. A method of forming a branched transmyocardial revascularization (TMR) channel in a predetermined portion of the myocardium, comprising: (a) forming an opening in the epicardial layer of the ventricle; Transmitting a first amount of laser energy through the aperture at an angle to the epicardial surface such that a first branch is formed in the myocardium; and (c) one or more. A second amount of laser energy is passed through the opening to the epicardial surface so that a second branch is formed in the myocardium in communication with the first branch at the point Transmitting at a second predetermined angle different from the predetermined angle. 8. The method of claim 7, wherein step (a) further comprises transmitting a sufficient amount of laser energy to the epicardial surface to form at least one through hole. the method of. 9. The method of claim 7, further comprising transmitting a sufficient amount of laser energy to the at least one branch to penetrate the endocardium. 10. The method of claim 10, further comprising: (d) applying an additional amount of laser energy through the aperture at an additional predetermined angle to the epicardial layer to form a plurality of branches in the myocardium. Communicating, thereby forming multiple branches of a TMR channel that are communicating with each other;
8. The method of claim 7, comprising forming a nearby forked TMR channel. 11. Proximal bifurcated myocardial revascularization (T
MR) forming a channel in a predetermined portion of the myocardium, comprising: (a) forming an opening in the epicardium by mechanical perforation; and (b) inserting a hollow guide needle into the opening. (C) passing a first amount of laser energy through the hollow guide needle and determined by the angular orientation of the hollow guide needle, such that a first branch of the TMR channel is formed in the myocardium. Transmitting at a predetermined angle to the epicardial surface; (d) rotating the hollow guide needle in a second predetermined angular direction within the opening in the epicardial surface; and (e) TMR channel. A second amount of laser energy through the hollow guide needle, as determined by the second angular orientation of the hollow guide needle, such that a second branch of the second is formed in the myocardium. Transmitting at an angle. 12. The distal end of the laser transmitting means may include the distal end of the guide needle prior to the step of transmitting the second amount of laser energy through the hollow guide needle at a second predetermined angle. 12. The method according to claim 11, comprising the additional step of retracting the laser transmission means so that it does not extend beyond the opening of the laser transmission means. 13. The method according to claim 11, wherein at least one branch of the TMR channel extends through the endocardium. 14. A guide block device for a surgical transmyocardial revascularization (TMR) procedure, comprising a body for placement over an epicardium of a heart, the body comprising upper and lower surfaces, and an upper surface. An opening disposed between the opening and the lower surface; and a centering means for surrounding the opening, extending through the body from the opening, and angling the laser transmission means to form an adjacent branched TMR channel. And a support surface for forming the guide block. 15. The guide block device further comprising a hollow guide needle, wherein the guide needle has a proximal end, a central axis, and a distal end that is sharpened to mechanically pierce the epicardial surface. 15. The guide block device according to claim 14, wherein the hollow guide needle orients the laser transmission means to transmit laser energy to a predetermined portion of the myocardium. 16. Bifurcated myocardial revascularization (TMR)
A rotation guide device for forming a channel, the housing having an upper surface, a lower surface, and a housing disposed on the epicardial surface adjacent to a predetermined portion of the myocardium; A hollow guide operably connected to the rotating head means, the hollow guide having a central axis, a proximal end, and a distal end sharpened to mechanically pierce the epicardial surface. The laser energy through the hollow guide needle means and the epicardial surface to a predetermined portion of the myocardium such that a first branch is formed that extends into the myocardium. The hollow guide needle means orienting the laser transmission means for transmitting at a first predetermined angle relative to the adventitia surface; and the laser transmission means being retractable through the hollow guide needle means. The second branch is formed Wherein the hollow guide needle means is rotatable to transmit laser energy through the hollow guide needle means and the epicardial surface to a predetermined portion of the myocardium at a second predetermined angle relative to the epicardial surface. And a first branch and a second branch are combined to form an adjacent branched TMR channel. 17. To deflect the distal end of the laser delivery device by an angle with respect to the central axis of the hollow guide needle device,
17. The rotary guide device according to claim 16, wherein the hollow guide needle device further comprises a distal end curvature. 18. The distal end of the guide needle is positioned at a predetermined number of angular positions to enable the laser transmitting means to transmit laser energy into the myocardium at a predetermined angle to the epicardium. 17. The rotation guide device according to claim 16, wherein the rotation head is provided with a predetermined number of angular positions so as to be directed toward the rotation head. 19. The rotation guide device according to claim 16, further comprising a handle attached to the housing. 20. The device according to claim 16, further comprising stabilizing means for forming a secure anchor point between the device and the epicardial surface. 21. The stabilizing means is integral with the housing portion, thereby forming an evacuable chamber extending slightly below the housing portion when positioned adjacent the epicardial layer. A flexible bellows portion, in communication with the vacuum supply so that the rotation guide device can be evacuated when the rotation guide device is positioned adjacent to the epicardial layer, thereby rotating the rotation guide device. 21. The rotation guide device according to claim 20, comprising a vacuum port for supplying a vacuum seal between the device and the epicardial layer. 22. The rotation guide device according to claim 20, wherein the stabilizing means comprises a guide needle means. 23. The rotation guide device according to claim 19, further comprising a laser transmission means advancing mechanism mounted inside the handle. 24. A laser transmission means advancing mechanism comprising a laser transmission means holding means and an actuator; a laser transmission means holding means for holding the laser transmission means in a safe position inside a handle; 24. The rotation guide device according to claim 23, wherein the transmission means is moved forward and backward by a predetermined distance through the inside of the handle. 25. The rotation guide device according to claim 23, wherein the laser transmission means advancing mechanism comprises a motor for advancing the laser transmission device by a predetermined distance. 26. The apparatus according to claim 16, wherein the rotating head means comprises a worm gear assembly. 27. The handle portion is elongated in the form of a hand wand for the convenience of manual control, and the elongated handle has a distal end from which laser transmission means can be inserted into the handle portion. Wherein the handpiece further comprises a manifold for guiding the laser transmission means from the handle portion to the head device and further into the hollow tubular opening of the guide needle means. The rotation guide device as described in the above. 28. A guide needle for forming a bifurcated TMR channel, comprising a hollow tubular body terminating at a distal tip that is curved to deflect a fiber optic laser transmission means mounted therein. A guide needle, characterized in that: