CA1259104A - Method and apparatus for transmyocardial revascularization using a laser - Google Patents
Method and apparatus for transmyocardial revascularization using a laserInfo
- Publication number
- CA1259104A CA1259104A CA000504265A CA504265A CA1259104A CA 1259104 A CA1259104 A CA 1259104A CA 000504265 A CA000504265 A CA 000504265A CA 504265 A CA504265 A CA 504265A CA 1259104 A CA1259104 A CA 1259104A
- Authority
- CA
- Canada
- Prior art keywords
- needle
- laser
- laser beam
- surgical
- instrument
- Prior art date
- Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
- Expired
Links
Classifications
-
- 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
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/201—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser with beam delivery through a hollow tube, e.g. forming an articulated arm ; Hand-pieces therefor
-
- 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
- A61B18/18—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves
- A61B18/20—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser
- A61B18/22—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor
- A61B18/24—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter
- A61B18/245—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body by applying electromagnetic radiation, e.g. microwaves using laser the beam being directed along or through a flexible conduit, e.g. an optical fibre; Couplings or hand-pieces therefor with a catheter for removing obstructions in blood vessels or calculi
-
- 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
-
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B90/00—Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
- A61B90/03—Automatic limiting or abutting means, e.g. for safety
- A61B2090/033—Abutting means, stops, e.g. abutting on tissue or skin
- A61B2090/036—Abutting means, stops, e.g. abutting on tissue or skin abutting on tissue or skin
Abstract
Abstract of the Disclosure A surgical carbon dioxide laser is disclosed which includes a handpiece for directing a laser beam to a desired location. Mounted on the forward end of the handpiece is a hollow needle precisely aligned along the laser path. This permits the laser to be used in surgical applications where the needle perfo-rates a portion of tissue to provide the laser beam direct access to distal tissue. The needle is mounted to the handpiece in a manner which provides for forward and lateral adjustment of the needle relative to the laser beam path which insures co-axiality between the laser beam and the needle lumen. This is crucial for the safe use of the laser. The needle is adjusted such that the focal point of the laser beam is approximately at the tip of the needle. This provides maximum energy at the tip of the needle where it is required. This apparatus is particularly useful in transmyocardial devices utilized to provide ischemic endocardial tissue direct access to blood within the ventricular cavity. The device is inserted within the epicardium of the heart; the laser is then activated to vaporize a channel of tissue through the endocardium. This provides for perforation of the endocardium with minimal damage to the epicardium.
Description
~-z~
Method and Apparatus for Transmyocardial Revascularization Uslng a Laser Background of the Invention The laser has developed into a very useful tool in modern surgery. Because of pinpoint accuracy and minimal peripheral thermal damage, the laser has found wide use in many areas of medicine. With the introduction of laser units with 25 to 100 watts power output, the carbon dioxide laser has begun to be usPd for excision and vaporization of tissue in neuro-surgery and plastic surgery as well as gastro-enterology, urology, otolaryngology, gynecology and, most recently, in cardiac applications.
Lasers are particularly usefui in transmyo-cardial revascularlzation. Transmyocardial revascu-larization is a recently developed method for treating ischemic heart disease. Heart disease is the leading cause of disability and death in all industrialized nations~ accounting for nearly twice as many deaths as those resulting from cancer. The majority of these deaths are due to ischemic heart disease, a condition in ~hich the heart muscle or myocardium does not ~L~rz~9~
receive an adequate nutritive blood supply. Trans-myocardial revascularization is a technique used to supplement the blood supply delivered to the heart by providing the ischemic inner sur~ace ~endocardium) direct access to blood within the ventricular chamber.
Normally the endocardium does not have direct access to the ventricular chamber and receives its nutritive blood supply entirely from the coronary arteries branching through the heart wall from its outer surface (epicardium).
A carbon dioxide laser has been used in transmyocardial revascularization. In short, the laser was used to vaporize tissue from the epicardium through the endocardium to the ventricular chamber, thereby promoting the ischemic myocardium direc~
access to blood within the chamber.
Using the above technique creates several problems. The vaporized tissue at the heart's outer surface (epicardium) must be sutured to prevent copious blood loss due to the forceful pumping action of the ventricular cavity. This is time-consuming and clearly dangerous to the patient. Further, the focal point of the laser beam cannot be maintained as it proceeds from the epicardium through the endocardium.
If the laser beam is focused at the epicardial sur-face, it will be unfocused mid-way through the heart wall. An unfocused CO2 laser beam does not precisely vaporize the tissue, but instead merely heats and ~2~9~ [)4 coagulates the tissue. This doe5 not allow for iaser perforation through a thick tissue wall. Prolonged durations of the laser beam are required to penetrate thP full thickness of the heart wall. This is especially pertinent to the hypertrophied heart.
Prolonged exposure to the high energy of the laser beam exposes peripheral tissue to dangerously exces-slve thermal damage. Furthermore, controlled perfor-ation in a rapidly beating heart may be impossible with prolonged durations of laser activation~ It is also difficult to create a straight channel from the epicardium to the endocardium using the above tech-nique in a beating heart.
Generally a large number of perforations are required. -The epicardium must be reperforated for each channel created. But channels within the epi-cardium are usually inappropriate. In most conditions of ischemic heart disease, it is the endocardium, not the epicardium, which is deprived of a nutritive blood supply. In the above technique, the vaporization of the epicardium is incidental to providing the laser beam access to the endocardial tissue.
Although there are many different types of instruments used to focus a laser for surgical uses to date none of these implements are adaptable for use in transmyocardial revascularization. Many different devices have been used to provide for precise applica-tion of a laser beam in surgical applications in-~2s9~
~4--cluding the combination of a laser beam with a laparo-scope or in combination with an endoscope. These devices focus the laser beam slightly beyond the distal end of the operating channel of either the endoscope or the laparoscope and provide an intense laser ~eam at a precise location.
Another device used to apply a laser beam to a particular location is described in Davi U.S. Patent 4,266,548. Davi discloses a surgical laser coupled with a hollow canula to direct a laser beam to tissue which is to be vaporized. This apparatus is used in the treatment of cardiac myopathies due to structural and functional abnormalities. In this application an incision is made in the heart to locate the area to be vaporized and provide access to the canula.
Clark U.S. Patent 4,336,809 discloses a - xenon ion laser which uses an optical needle to apply laser light to a desired area. The needle has a fiber optic core used to ~ransmit the light to the desired region. Such fiber optic systems are presently incom-patible with high intensity infrared lasers such as carbon dioxide lasers. Therefore, it is unsuitable for use when high intensity radiation is required.
Summar of the Invention The present invention is premised on the realization that a surgical instrument can be provided which includes a needle which is adapted to be mounted to a laser body with means to align the shaft of the ~ 5~0A~
needle along the path of the laser beam. The needle acts to cut or perforate tissue and provi~e a path for the laser beam.
Further, the invention is premised upon the realization that such a surgical instrument can be provided with means to axially adjust the needle to enable the tip of the needle to be positioned at the focal point o~ the laser beam. This permits use of different needles having different lengthsr yet maintaining the tip of the needle at the focal point of the laser beam.
A preferred embodiment of the in~ention incorporates a CO2 sur~ical laser. This instrument can be specially adapted for use in particular opera-tions such as transmyocardial revascularization wherein the shaft of the needle i5 specially adapted or sized for this end use.
The surgical laser can be provided with an injection port to permit forcing of saline through the needle to clean out the interior of the needle.
The present invention is further premised upon the reallzation that transmyocardial revascular-ization can be performed efficiently with minimal damage to the epicardium by focusins a carbon dioxide laser through a short needle, puncturing the epi-cardium with the needle and subse~uently cutting through the endocardium with the laser beam.
~s~
The technique of transmyocardial revascular-i~ation is significantly improved when aided b~ the present invention. By initially perforating the epicardium with the laser needle device, the needle's ~ip is then exposed to the endocardium for lasering and vaporization. The insertion of the device within the epicardium does not vaporize the tissue o~ the outer heart wall. Instead, it simply separates the ~issue which recoils to its native position after the needle's removal. With use of the disclosed apparatus, each of the above cited problems is remedied. There is no vapcrization of the heart's outer surface, thereby eliminating surface bleeding and the need for suture. Because the laser beam is focused not at the epicardial surface but at the needle's tip a sharp focus is provided at the endocardium. This invention pxovides for only vaporization of the endocardium, thereby significantly decreasing the duration of laser activation. Also, placement of the apparatus within the epicardium serves to, in effect, anchor the laser beam. The device moves in accordance with the heart-beat, thereby decreasing peripheral damage. The present invention permits formation of multiple channels within the endocardium with only one needle perforation of the epicardium. Once the apparatus is inserted within the epicardium, multiple pivots of the handpiece at different angles provide multiple endo-cardial channels. The vaporized channels are appro-priately created only within the endocardiumO
This invention as well as its advantages will be further appreciated in light of the following detailed description and drawings in which:
f Descri tion of the Drawinqs Brle p Fig. 1 is a schematic view of a surgical laser system for use with the present invention;
Fig. 2 is a cross-sectional view of the handpiece of the present invention;
Fig. 3 is a cross-sectional perspective view broken away Or the heart undergoing transmyocardial revascularization according to the method of the present invention; and Fig~ 4 is a view similar to Fig. 3 illus-trating the manner in which the laser may provide multiple perforations.
Detailed Des_ription As shown in Fig. 1, a surgical laser ll suitable for use in transmyocardial revascularization includes a source of high energy laser light depicted diagrammatically as 12. Preferably this source of laser light will be a carbon dioxide laser which radiates a beam of high energy laser liqht through a series of arms 13 to a hand held manipulator or handpiece 14. ~he arms 13 include a series of mirrors (such as mirror 16, Fig. 2) which direct the generated laser beam to the handpiece 14 nd permit relatively ree movement of the handpiece independent the carbon ()4 dioxide laser 12. A remote foot switch (not shown) is also provided to activate the laser.
The handpiece 14 includes a tubular body 15 which provides a path for a laser beam directed from S the mirror 16 to the forward end 17 of body 15. Also within the body 15 is a focusing lens 20 which acts to focus the carbon dioxide laser beam at a fixed focal - point 21 forward of forward end 17. The lens directs the laser light reflected from mirror 16 along a laser beam path shown in dotted lines 19. The laser beam reaches its highest intensity at its focal point 21.
This focal point is determined by the location and shape of lens 20.
The laser beam path extends through a hollow needle 22. The needle 22 includes a pointed tip 23, shank 24 and an enlarged body portion or hub 25. The hub 25 has flared shoulders 26 which cooperate with external threads 33 of a needle mount or holder 27 to provide a means to attach the needle 22 and hold it stationary with respect to the handpiece. The interior of hub 25 is preferably hollowed out as much as possible to provide clearance for the laser beam.
The needle 22 mounts to the body 15 of handpiece 14 in a manner which enables the location of the needle to be adjusted relative to the body 15 and thus relati~e to the laser beam path. More specif-ically, the needle 22 threads into needle mount 27 which is adjustably positioned within a hollow ~2~9~
cylindrical holder 28. The holder 28 is fixed to the body 15 by a cap 29.
The needle mount includes a hollow cylindri-cal metal body 31 and a tubular extension 30 adapted to fit within the hub of needle 22. The externally threaded portion 33 lies between the tubular extension 30 and the body 31.
The needle mount 27 is spaced from the tubular holder 28. This spacing permits the needle mount to be moved forwardly, rearwardly and laterally relative to the holder 28 and thus relative to the handpiece 14 to insure that the laser path extends directly through the needle 22. The exact posikion of needle mounk 27 relative ko the holder 28 is fixed by a pair of opposed set screws 34 and 35 which pass through the holder 28 and impinge upon the surface of needle mount 27. Thus these provide for forwardj rearward and lateral adjustment of the needle mount and thus needle 22 relative to the body lS.
The holder 28 has a shoulder 36 which abu~s the end surface 37 of the body 15 of the handpiece 14.
Holder 28 is held in place by cap 29 which can be fixed to the body 15 by various means. As shown in Fig. 1, the cap is held in position by set screw 29a.
The handpiece is also provided with struc-ture which permits the flushing of the needle with saline should ik become plugged or fouled. The handpiece includes a port 46 which permits o~
introduction of saline into the handpiece between lens 20 and needle 2~. Saline forced into port 46 floods the area between lens 20 and needle 22. The saline is forced through the shank 24 of the needle cl~aning the needle.
- In operation the laser light generated by the carbon dioxide laser 12 reflects ofi mirror 16 passes through the handpiece through lens 20 where it is focused at focal point 21. The focal point 21 should lie at the tip of needle 22 or at least within about 3 cm of the tip. Further the laser beam path 19 should pass directly through the hollow interior of ~he needle. To provide for this the needle is mounted on needle mount 27 and the needle mount 27 is adjusted relative to holder 28 and laser body 15 to align the hollow interior of the needle along the laser path with the tip 23 of the needle at about the focal point 21. The focal point for a laser with a certain lens should be known and thus the position of the needle point adjusted accordingly. The forward and rearward adjustment is made by removing cap 29, loosening the set screws 34 and 35 and moving the needle mount 27 orwardly or rearwardly relative to holder. This adjustment permits needles having various length shanks to be used and interchanged if desired. The lateral adjustment is established by relative movement of the set screws 34 and 35.
59~)4 This laser can be used in operations in which a laser beam is required at an unexposed portion of an organ. The point of the needle is sharp enough so that as it penetrates tissue it creates an opening by spreading the tissue apart providing a path for the laser beam. This causes only minimal tissue damage.
The length of the needle shank is chosen according to the desired depth of this needle puncture and will vary from operation to operation. The gaugs of the needle is also a variable according to the size of the generated laser beam. Typically an 18 gauge thin welled needle is suitable, although a different gauge needle may be desired or xe~uired with different carbon dioxide lasers.
One particular application for which this apparatus is particularly suited is transmyocardial revascularization. In this application it is desir-able to cut holes through the endocardium into one of the heart cavities to allow blood to pass from the cavity into the endocardium. Typically this method will be used to restore blood flow to an ischemic subendocardium perhaps associated with left ventricu-lar hypertrophy. Specifically this provides ven-tricular blood to the myocardial vasculature.
According to the present invention, trans-myocardial revascularization is conducted by surgi-cally exposiny the e~terior sur~ace of the heart. The left anterior free wall of the left ventricle near the ~s~
left anterior descending and left circumflex coro-naries are subjected to laser treatment. These are the areas which tend to be most ischemic. The ischemic areas are provided with as many perforations as possible without affecting the contractility of the heart. Generally in any area 10 to 20 perforations per square centimeter are created.
As shown in Fig. 3, to perforate the endo-cardial tissue of the left anterior free wall of the left ventricle the needle 22 is simply pressed into the epicardial portion 42 of the anterior free wall of the heart 39 until hub 25 abuts ayainst the epicardial surface 41 of the heart. Typically an ischemic heart can have a thickness of approximately 20 millimeters.
Preferably the shank of the needle is about 14 milli-meters providing a laser induced perforation o about 6 millimeters. Once the needle is forced into the heart the laser is activated for a period of time sufficient to penetrate through the remaining portion of the endocardium into the left ventricle cavity providing a perforation 43 through the endocardium 44.
Generally a period of one to two seconds is suf icient with a laser having 80 watts power. The handpiece is then pulled away to pull the needle from the heart.
The needle is reinserted at a separate location and the procedure is repeated until the desired density of perforations is obtained.
259~
-13~
As shown in Fig. 4 an alternate method of providing multiple perforations is to insert the needle through the epicardium 42 towards the endo-~ Gardium 44 and provide multiple perforations 45a, 45b and 45c in the endocardium 44. This is accomplished by pushing the needle into the epicardium 42, acti-vating the laser to create first perforation 45a, and subse~uently pivoting the handpiece, and again actu-ating the laser to form second perforation 45b. The handpiece can then be pivoted again about the laser tip and third perforation 45c can be made from the same point but at different angles to provide multiple perforations. This in effect increases the number of perforations through the endocardium without in-creasing the number of perforations through the epicardium~ This reduces the effect this surgical procedure has on the contractility of the heart.
These laser induced perforations provide a flow path for blood into the endocardium from the ventricular chamber.
The use of surgical laser of the present invention is not limited to transmyocardial revas-cularization. Those skilled in the art will readily appreciate the use of the laser in various applica-tions to obtain the benefits of the present invention~
Thus having described my invention I claim:
Method and Apparatus for Transmyocardial Revascularization Uslng a Laser Background of the Invention The laser has developed into a very useful tool in modern surgery. Because of pinpoint accuracy and minimal peripheral thermal damage, the laser has found wide use in many areas of medicine. With the introduction of laser units with 25 to 100 watts power output, the carbon dioxide laser has begun to be usPd for excision and vaporization of tissue in neuro-surgery and plastic surgery as well as gastro-enterology, urology, otolaryngology, gynecology and, most recently, in cardiac applications.
Lasers are particularly usefui in transmyo-cardial revascularlzation. Transmyocardial revascu-larization is a recently developed method for treating ischemic heart disease. Heart disease is the leading cause of disability and death in all industrialized nations~ accounting for nearly twice as many deaths as those resulting from cancer. The majority of these deaths are due to ischemic heart disease, a condition in ~hich the heart muscle or myocardium does not ~L~rz~9~
receive an adequate nutritive blood supply. Trans-myocardial revascularization is a technique used to supplement the blood supply delivered to the heart by providing the ischemic inner sur~ace ~endocardium) direct access to blood within the ventricular chamber.
Normally the endocardium does not have direct access to the ventricular chamber and receives its nutritive blood supply entirely from the coronary arteries branching through the heart wall from its outer surface (epicardium).
A carbon dioxide laser has been used in transmyocardial revascularization. In short, the laser was used to vaporize tissue from the epicardium through the endocardium to the ventricular chamber, thereby promoting the ischemic myocardium direc~
access to blood within the chamber.
Using the above technique creates several problems. The vaporized tissue at the heart's outer surface (epicardium) must be sutured to prevent copious blood loss due to the forceful pumping action of the ventricular cavity. This is time-consuming and clearly dangerous to the patient. Further, the focal point of the laser beam cannot be maintained as it proceeds from the epicardium through the endocardium.
If the laser beam is focused at the epicardial sur-face, it will be unfocused mid-way through the heart wall. An unfocused CO2 laser beam does not precisely vaporize the tissue, but instead merely heats and ~2~9~ [)4 coagulates the tissue. This doe5 not allow for iaser perforation through a thick tissue wall. Prolonged durations of the laser beam are required to penetrate thP full thickness of the heart wall. This is especially pertinent to the hypertrophied heart.
Prolonged exposure to the high energy of the laser beam exposes peripheral tissue to dangerously exces-slve thermal damage. Furthermore, controlled perfor-ation in a rapidly beating heart may be impossible with prolonged durations of laser activation~ It is also difficult to create a straight channel from the epicardium to the endocardium using the above tech-nique in a beating heart.
Generally a large number of perforations are required. -The epicardium must be reperforated for each channel created. But channels within the epi-cardium are usually inappropriate. In most conditions of ischemic heart disease, it is the endocardium, not the epicardium, which is deprived of a nutritive blood supply. In the above technique, the vaporization of the epicardium is incidental to providing the laser beam access to the endocardial tissue.
Although there are many different types of instruments used to focus a laser for surgical uses to date none of these implements are adaptable for use in transmyocardial revascularization. Many different devices have been used to provide for precise applica-tion of a laser beam in surgical applications in-~2s9~
~4--cluding the combination of a laser beam with a laparo-scope or in combination with an endoscope. These devices focus the laser beam slightly beyond the distal end of the operating channel of either the endoscope or the laparoscope and provide an intense laser ~eam at a precise location.
Another device used to apply a laser beam to a particular location is described in Davi U.S. Patent 4,266,548. Davi discloses a surgical laser coupled with a hollow canula to direct a laser beam to tissue which is to be vaporized. This apparatus is used in the treatment of cardiac myopathies due to structural and functional abnormalities. In this application an incision is made in the heart to locate the area to be vaporized and provide access to the canula.
Clark U.S. Patent 4,336,809 discloses a - xenon ion laser which uses an optical needle to apply laser light to a desired area. The needle has a fiber optic core used to ~ransmit the light to the desired region. Such fiber optic systems are presently incom-patible with high intensity infrared lasers such as carbon dioxide lasers. Therefore, it is unsuitable for use when high intensity radiation is required.
Summar of the Invention The present invention is premised on the realization that a surgical instrument can be provided which includes a needle which is adapted to be mounted to a laser body with means to align the shaft of the ~ 5~0A~
needle along the path of the laser beam. The needle acts to cut or perforate tissue and provi~e a path for the laser beam.
Further, the invention is premised upon the realization that such a surgical instrument can be provided with means to axially adjust the needle to enable the tip of the needle to be positioned at the focal point o~ the laser beam. This permits use of different needles having different lengthsr yet maintaining the tip of the needle at the focal point of the laser beam.
A preferred embodiment of the in~ention incorporates a CO2 sur~ical laser. This instrument can be specially adapted for use in particular opera-tions such as transmyocardial revascularization wherein the shaft of the needle i5 specially adapted or sized for this end use.
The surgical laser can be provided with an injection port to permit forcing of saline through the needle to clean out the interior of the needle.
The present invention is further premised upon the reallzation that transmyocardial revascular-ization can be performed efficiently with minimal damage to the epicardium by focusins a carbon dioxide laser through a short needle, puncturing the epi-cardium with the needle and subse~uently cutting through the endocardium with the laser beam.
~s~
The technique of transmyocardial revascular-i~ation is significantly improved when aided b~ the present invention. By initially perforating the epicardium with the laser needle device, the needle's ~ip is then exposed to the endocardium for lasering and vaporization. The insertion of the device within the epicardium does not vaporize the tissue o~ the outer heart wall. Instead, it simply separates the ~issue which recoils to its native position after the needle's removal. With use of the disclosed apparatus, each of the above cited problems is remedied. There is no vapcrization of the heart's outer surface, thereby eliminating surface bleeding and the need for suture. Because the laser beam is focused not at the epicardial surface but at the needle's tip a sharp focus is provided at the endocardium. This invention pxovides for only vaporization of the endocardium, thereby significantly decreasing the duration of laser activation. Also, placement of the apparatus within the epicardium serves to, in effect, anchor the laser beam. The device moves in accordance with the heart-beat, thereby decreasing peripheral damage. The present invention permits formation of multiple channels within the endocardium with only one needle perforation of the epicardium. Once the apparatus is inserted within the epicardium, multiple pivots of the handpiece at different angles provide multiple endo-cardial channels. The vaporized channels are appro-priately created only within the endocardiumO
This invention as well as its advantages will be further appreciated in light of the following detailed description and drawings in which:
f Descri tion of the Drawinqs Brle p Fig. 1 is a schematic view of a surgical laser system for use with the present invention;
Fig. 2 is a cross-sectional view of the handpiece of the present invention;
Fig. 3 is a cross-sectional perspective view broken away Or the heart undergoing transmyocardial revascularization according to the method of the present invention; and Fig~ 4 is a view similar to Fig. 3 illus-trating the manner in which the laser may provide multiple perforations.
Detailed Des_ription As shown in Fig. 1, a surgical laser ll suitable for use in transmyocardial revascularization includes a source of high energy laser light depicted diagrammatically as 12. Preferably this source of laser light will be a carbon dioxide laser which radiates a beam of high energy laser liqht through a series of arms 13 to a hand held manipulator or handpiece 14. ~he arms 13 include a series of mirrors (such as mirror 16, Fig. 2) which direct the generated laser beam to the handpiece 14 nd permit relatively ree movement of the handpiece independent the carbon ()4 dioxide laser 12. A remote foot switch (not shown) is also provided to activate the laser.
The handpiece 14 includes a tubular body 15 which provides a path for a laser beam directed from S the mirror 16 to the forward end 17 of body 15. Also within the body 15 is a focusing lens 20 which acts to focus the carbon dioxide laser beam at a fixed focal - point 21 forward of forward end 17. The lens directs the laser light reflected from mirror 16 along a laser beam path shown in dotted lines 19. The laser beam reaches its highest intensity at its focal point 21.
This focal point is determined by the location and shape of lens 20.
The laser beam path extends through a hollow needle 22. The needle 22 includes a pointed tip 23, shank 24 and an enlarged body portion or hub 25. The hub 25 has flared shoulders 26 which cooperate with external threads 33 of a needle mount or holder 27 to provide a means to attach the needle 22 and hold it stationary with respect to the handpiece. The interior of hub 25 is preferably hollowed out as much as possible to provide clearance for the laser beam.
The needle 22 mounts to the body 15 of handpiece 14 in a manner which enables the location of the needle to be adjusted relative to the body 15 and thus relati~e to the laser beam path. More specif-ically, the needle 22 threads into needle mount 27 which is adjustably positioned within a hollow ~2~9~
cylindrical holder 28. The holder 28 is fixed to the body 15 by a cap 29.
The needle mount includes a hollow cylindri-cal metal body 31 and a tubular extension 30 adapted to fit within the hub of needle 22. The externally threaded portion 33 lies between the tubular extension 30 and the body 31.
The needle mount 27 is spaced from the tubular holder 28. This spacing permits the needle mount to be moved forwardly, rearwardly and laterally relative to the holder 28 and thus relative to the handpiece 14 to insure that the laser path extends directly through the needle 22. The exact posikion of needle mounk 27 relative ko the holder 28 is fixed by a pair of opposed set screws 34 and 35 which pass through the holder 28 and impinge upon the surface of needle mount 27. Thus these provide for forwardj rearward and lateral adjustment of the needle mount and thus needle 22 relative to the body lS.
The holder 28 has a shoulder 36 which abu~s the end surface 37 of the body 15 of the handpiece 14.
Holder 28 is held in place by cap 29 which can be fixed to the body 15 by various means. As shown in Fig. 1, the cap is held in position by set screw 29a.
The handpiece is also provided with struc-ture which permits the flushing of the needle with saline should ik become plugged or fouled. The handpiece includes a port 46 which permits o~
introduction of saline into the handpiece between lens 20 and needle 2~. Saline forced into port 46 floods the area between lens 20 and needle 22. The saline is forced through the shank 24 of the needle cl~aning the needle.
- In operation the laser light generated by the carbon dioxide laser 12 reflects ofi mirror 16 passes through the handpiece through lens 20 where it is focused at focal point 21. The focal point 21 should lie at the tip of needle 22 or at least within about 3 cm of the tip. Further the laser beam path 19 should pass directly through the hollow interior of ~he needle. To provide for this the needle is mounted on needle mount 27 and the needle mount 27 is adjusted relative to holder 28 and laser body 15 to align the hollow interior of the needle along the laser path with the tip 23 of the needle at about the focal point 21. The focal point for a laser with a certain lens should be known and thus the position of the needle point adjusted accordingly. The forward and rearward adjustment is made by removing cap 29, loosening the set screws 34 and 35 and moving the needle mount 27 orwardly or rearwardly relative to holder. This adjustment permits needles having various length shanks to be used and interchanged if desired. The lateral adjustment is established by relative movement of the set screws 34 and 35.
59~)4 This laser can be used in operations in which a laser beam is required at an unexposed portion of an organ. The point of the needle is sharp enough so that as it penetrates tissue it creates an opening by spreading the tissue apart providing a path for the laser beam. This causes only minimal tissue damage.
The length of the needle shank is chosen according to the desired depth of this needle puncture and will vary from operation to operation. The gaugs of the needle is also a variable according to the size of the generated laser beam. Typically an 18 gauge thin welled needle is suitable, although a different gauge needle may be desired or xe~uired with different carbon dioxide lasers.
One particular application for which this apparatus is particularly suited is transmyocardial revascularization. In this application it is desir-able to cut holes through the endocardium into one of the heart cavities to allow blood to pass from the cavity into the endocardium. Typically this method will be used to restore blood flow to an ischemic subendocardium perhaps associated with left ventricu-lar hypertrophy. Specifically this provides ven-tricular blood to the myocardial vasculature.
According to the present invention, trans-myocardial revascularization is conducted by surgi-cally exposiny the e~terior sur~ace of the heart. The left anterior free wall of the left ventricle near the ~s~
left anterior descending and left circumflex coro-naries are subjected to laser treatment. These are the areas which tend to be most ischemic. The ischemic areas are provided with as many perforations as possible without affecting the contractility of the heart. Generally in any area 10 to 20 perforations per square centimeter are created.
As shown in Fig. 3, to perforate the endo-cardial tissue of the left anterior free wall of the left ventricle the needle 22 is simply pressed into the epicardial portion 42 of the anterior free wall of the heart 39 until hub 25 abuts ayainst the epicardial surface 41 of the heart. Typically an ischemic heart can have a thickness of approximately 20 millimeters.
Preferably the shank of the needle is about 14 milli-meters providing a laser induced perforation o about 6 millimeters. Once the needle is forced into the heart the laser is activated for a period of time sufficient to penetrate through the remaining portion of the endocardium into the left ventricle cavity providing a perforation 43 through the endocardium 44.
Generally a period of one to two seconds is suf icient with a laser having 80 watts power. The handpiece is then pulled away to pull the needle from the heart.
The needle is reinserted at a separate location and the procedure is repeated until the desired density of perforations is obtained.
259~
-13~
As shown in Fig. 4 an alternate method of providing multiple perforations is to insert the needle through the epicardium 42 towards the endo-~ Gardium 44 and provide multiple perforations 45a, 45b and 45c in the endocardium 44. This is accomplished by pushing the needle into the epicardium 42, acti-vating the laser to create first perforation 45a, and subse~uently pivoting the handpiece, and again actu-ating the laser to form second perforation 45b. The handpiece can then be pivoted again about the laser tip and third perforation 45c can be made from the same point but at different angles to provide multiple perforations. This in effect increases the number of perforations through the endocardium without in-creasing the number of perforations through the epicardium~ This reduces the effect this surgical procedure has on the contractility of the heart.
These laser induced perforations provide a flow path for blood into the endocardium from the ventricular chamber.
The use of surgical laser of the present invention is not limited to transmyocardial revas-cularization. Those skilled in the art will readily appreciate the use of the laser in various applica-tions to obtain the benefits of the present invention~
Thus having described my invention I claim:
Claims (10)
PROPERTY OR PRIVILEGE IS CLAIMED ARE DEFINED AS FOLLOWS:
1. A surgical instrument comprising a surgical needle having an elongated hollow shaft and an end for cutting through tissue, said shaft adapted for the passage of a laser beam therethrough, and means for axially adjusting said needle with respect to a body providing said laser beam to align said needle with said laser beam.
2. The surgical instrument claimed in claim 1 wherein said instrument is adapted for mounting to said body.
3. The surgical instrument claimed in claim 2 further comprising means to adjust said needle axially to position said end of said needle at about a focal point of said laser beam.
4. A surgical laser instrument comprising a laser body establishing a path for the passage of a laser beam therethrough, a surgical needle having an end for cutting through tissue and an elongated hollow shaft, means for mounting said needle with respect to said body, and means for axially adjusting said hollow shaft with respect to the path of said laser beam to align said shaft with said laser beam.
5. The surgical instrument claimed in claim 4 further comprising means to adjust said hollow shaft axially relative to said laser body to position said end of the needle at about a focal point of said laser beam, said focal point established by said laser body.
6. The instrument claimed in claim 5 further comprising a CO2 laser source adapted to generate said laser beam.
7. The instrument claimed in claim 5 wherein said instrument is adapted for use in transmyocardial revascularization.
8. The instrument claimed in claim 5 wherein said laser body includes a port adapted to permit introduction of a washing fluid into said body thereby permitting the shaft of said needle to be flushed with said washing solution.
9. A surgical laser instrument comprising:
a laser body having a path for the passage of a laser beam therethrough, a surgical needle having an end for cutting through tissue and an elongated hollow shaft for passage of the beam, and means to mount said needle to said body comprising a cap fixed to said body, said cap including means to adjust said needle axially and laterally relative to said body for focusing the laser beam at the end of said needle.
a laser body having a path for the passage of a laser beam therethrough, a surgical needle having an end for cutting through tissue and an elongated hollow shaft for passage of the beam, and means to mount said needle to said body comprising a cap fixed to said body, said cap including means to adjust said needle axially and laterally relative to said body for focusing the laser beam at the end of said needle.
10. The apparatus claimed in claim 9 wherein said cap includes a cylindrical holder and a needle mount positioned axially within said holder and fixed in place by at least one set screw extending through said holder against said needle mount.
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US718,069 | 1985-04-01 | ||
| US06/718,069 US4658817A (en) | 1985-04-01 | 1985-04-01 | Method and apparatus for transmyocardial revascularization using a laser |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| CA1259104A true CA1259104A (en) | 1989-09-05 |
Family
ID=24884700
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| CA000504265A Expired CA1259104A (en) | 1985-04-01 | 1986-03-17 | Method and apparatus for transmyocardial revascularization using a laser |
Country Status (4)
| Country | Link |
|---|---|
| US (1) | US4658817A (en) |
| EP (1) | EP0196519A3 (en) |
| JP (1) | JPS61268246A (en) |
| CA (1) | CA1259104A (en) |
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- 1985-04-01 US US06/718,069 patent/US4658817A/en not_active Expired - Fee Related
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- 1986-03-17 CA CA000504265A patent/CA1259104A/en not_active Expired
- 1986-03-28 JP JP61070645A patent/JPS61268246A/en active Pending
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| US4658817A (en) | 1987-04-21 |
| JPS61268246A (en) | 1986-11-27 |
| EP0196519A3 (en) | 1987-07-01 |
| EP0196519A2 (en) | 1986-10-08 |
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