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
  • A61B18/22—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
• • 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
  • A61B17/00234—Surgical instruments, devices or methods 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
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/0046—Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable
  • A61B2017/00469—Surgical instruments, devices or methods with a releasable handle; with handle and operating part separable for insertion of instruments, e.g. guide wire, optical fibre
• • A—HUMAN NECESSITIES
  • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
  • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
  • A61B17/00—Surgical instruments, devices or methods
  • A61B2017/00477—Coupling
  • A61B2017/00482—Coupling with a code
• • 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
  • A61B18/00—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
  • A61B2018/00982—Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body combined with or comprising means for visual or photographic inspections inside the body, e.g. endoscopes

Definitions

• FIG. 3 is an enlarged cross-sectional view of the proximal end of the optical fiber coupler of
• FIG. 1 connected to a laser energy generator prior to movement of the optical fiber
• FIG. 12 is a side view of the optical fiber extending through the heart tissue to form a channel therein;
• FIG. 15 is a side cross-sectional view of the optical fiber ablating plaque within the vasculature
• FIG. 19 is an enlarged cross-sectional view of the proximal end of the optical fiber coupler of
• FIG. 20 is a side cross-sectional view of the plunger mechanism of the optical fiber coupler of FIG. 17;
• FIG. 28 is a top partial cut-away view of the encoded optical fiber coupler shown in FIG. 24 with the plunger mechanism being acted upon by a translation rod of the laser energy generator to advance the optical fiber beyond the distal end of the handpiece;
• FIG. 29 is a perspective view of a first alternate embodiment of the encoded optical fiber coupler having a magnetic stripe for storing information
• FIG. 30 is an exploded, perspective view of the encoded optical fiber coupler of FIG. 29;
• FIG. 33 is a partial, perspective view showing the encoded optical fiber coupler of FIG. 30 being optically connected to the control module of FIG. 32;
• FIG. 34 is a perspective view of a second alternate embodiment of the encoded optical fiber coupler having an integrated circuit (IC) chip for storing information;
• FIG. 35 is a bottom view of the encoded optical fiber coupler of FIG. 34 showing the IC chip;
• IC integrated circuit
• FIG. 40 is a perspective view of an alternate TMR laser ablation device
• FIG. 41 is a perspective view of an alternate embodiment of a handle portion of a TMR disposable lasing unit
• FIG. 44 is a side, cross-sectional view of the handle portion shown in FIG. 40 accessing a ventricle through the apex of the heart;
• FIG. 45 is a side, cross-sectional view of the apparatus of an optical fiber extending from a distal end of the handle portion shown in FIG. 40 positioned to ablate endocardial tissue;
• FIG. 47 is a side, cross-sectional view of the optical fiber creating a channel within the heart tissue extending from the endocardium towards an inner surface of the epicardium;
• FIG. 48 is a side, cross-sectional view of the optical fiber after having been withdrawn from the heart tissue
• FIG. 49 is a side, cross-sectional view of an alternative embodiment of the handle portion of FIG. 40 having structure for coring the apex of the heart;
• FIG. 50 is a side, cross-sectional view of the embodiment of FIG. 49 creating a channel within the heart tissue extending from the endocardium towards an inner surface of the epicardium;
• FIG. 51 is a perspective view of an alternate, preferred handpiece suitable for use in TMR procedures
• FIG. 52 is an exploded perspective view of the handpiece of FIG. 51;
• FIG. 53 is an elevated cross-sectional view of the handpiece of FIG. 51;
• FIG. 54 is a detailed drawing of the proximal end of FIG. 53;
• FIG. 55 is a detailed drawing of the articulation control mechanism and associated internal structures of the handpiece shown in FIG. 53;
• FIG. 56 is a detailed drawing if the distal end of FIG. 53;
• FIG. 57 is an elevated cross-sectional view of the handpiece of FIG. 51 showing movement of the articulation control mechanism;
• FIG. 58 is an elevated cross sectional view of the proximal end of the handpiece of FIG. 51 shown with a laser fiber passing therethrough and in a fully articulated position;
• FIG. 61 is a perspective view of the handpiece of FIG. 51 and a minimally invasive access device
• FIG. 62 is an elevational view in partial cross-section of the instrument of FIG. 51 inserted through a minimally invasive access device disposed in a patient's chest, wherein the distal end of the device is in contact with heart tissue;
• FIG. 63 is a detailed drawing of a laser fiber extending from the distal end of the handpiece of FIG. 51 , wherein the laser fiber is pressing against heart tissue;
• FIG. 64 is a detailed drawing of a laser fiber extending from the distal end of the handpiece of FIG. 51 , wherein the laser fiber has penetrated heart tissue;
• FIG. 65 is a perspective view of the handpiece of FIG. 51 being inserted into an incision in a patient's chest to access heart tissue.
• FIG. 1 illustrates a preferred optical fiber coupler shown generally at 10 connected to handpiece 12 via laser fiber sheath 14.
• Coupler 10 includes a housing 16, a plunger mechanism 18, an optical connector 20, and an opening 22 at a distal end for passage of an optical fiber 24 therethrough.
• optical fiber 24 is disposed within housing 16 with the proximal end secured to nose module 26.
• Nose module 26 preferably includes a metallic portion 28 and a washer 30.
• Metallic portion 28 is preferably aluminum and includes conical section 32 and cylindrical section 34.
• Washer 30 is preferably rubber or a rubber-like material.
• Optical fiber 24 can protrude slightly from conical section 32 to become optically connected to a laser energy generator.
• plunger mechanism 18 preferably includes plunger 40, cylindrical drum 42, and spring 44.
• Optical fiber 24 enters cylindrical drum 42 through opening 46 (see FIG. 3).
• Optical fiber 24 exits the cylindrical drum 42 through a second opening 48 on distal face 50.
• Optical fiber 24 traverses spring 44 enters sheath 14.
• An internally threaded bushing 52 is disposed at opening 22 of coupler 10 and threadingly receives sheath 14 (see also FIG. 4). Bushing 52 can be rotated to increase or decrease the effective length of sheath 14 between coupler 10 and handpiece 12. By adjusting the length of sheath 14, the relative distance between coupler 10 .and handpiece 12 is adjustable.
• optical connector 20 is a female connector preferably having two backward "c" cut-outs 56 for matingly engaging an optical connector 58 of the laser as shown by FIGS. 6 and 7. It is contemplated that fastening mechanisms can be used to further secure coupler 10 with the laser, such as thumb screws.
• Preferred materials for coupler 10 and related parts include biocompatible plastics, polymers and metals.
• Optical fiber coupler 10 can also be provided with a transponder chip, designated as TC in FIGS. 2 and 3.
• Transponder chip TC is preferably a glass embedded chip having contact recognition capabilities.
• a sending and receiving antenna associated with the laser unit can read and process information contained within the chip.
• Information in the chip can include, for example, sterilization data, laser fiber and coupler information, including serial numbers associated with various parts and the like.
• laser energy transmission source engages the proximal end of optical fiber 24 to transmit laser energy to optical fiber 24 upon activation of the laser energy.
• a suitable laser energy generator is shown in FIG. 5 and designated by reference numeral 60.
• Laser generator 60 includes optical connection port 61 which includes optical connector 58 for connecting coupler 10 to the laser.
• Laser 60 further includes a foot operated actuator 62 that activates laser source 36 within the laser when it is depressed.
• Laser 60 is programmable to suspend energy transmission or movement of a laser fiber, if it is determined, for example, that the optical fiber 24 has sufficiently penetrated body tissue.
• laser 60 can be programmed to control the motors or similar advancing structure within the laser to control the advancement of optical fiber 24 upon actuation of foot operated actuator 62.
• Other suitable laser energy generators and fiber advancing mechanisms are disclosed herein and in commonly assigned U.S. patent application serial numbers 08/648,638 (filed May 13, 1996) and 08/720,934 (filed October 4, 1996).
• a mechanism and method for automatically controlling the longitudinal advancement of a laser fiber is disclosed in commonly assigned U.S. patent application serial number 60/053,309 (filed July 22, 1997).
• Laser 60 is shown with a programmable computer 64 having a terminal 66 for storing instructions required to operate an advancing mechanism 68 within the laser for activating plunger mechanism 18 of coupler 10.
• a toggle button 70 may be provided to switch from an operation mode to a test mode. In a particular test mode, when foot operated actuator 62 is acted upon, optical fiber 24 is moved sequentially from a retracted position, to a predetermined extended position, and back to the retracted position.
• the advancing mechanism 68 of the laser includes translation rod 72 with proximal end 74 capable of engaging plunger 40 of optical fiber coupler 10 for advancing optical fiber 24 upon activation of the laser.
• rod 72 has a slot configured to receive the proximal end of plunger 40 as coupler 10 is rotated into engagement with the laser.
• optical fiber 24 can be a single fiber or an optical fiber bundle or other laser energy transmission mechanism. Most preferably, optical fiber 24 is a bundle of fibers having a collective diameter of about 1.2mm to about 1.6mm.
• Controlled longitudinal motion of the optical fiber 24 can be provided by one or more motors and preferably by one or more D.C. motors within the laser to cause translation rod 72, thereby pushing plunger 40 distally to advance optical fiber 24 as further described below.
• stepper motors or other suitable drive mechanisms can be used.
• the laser can be either a continuous wave laser or a pulsed, high energy laser; such as, for example, an excimer, Yag, or an alexandrite laser.
• a pulsed high energy xenon chloride excimer laser is used, such as those available from Spectranetics of Colorado Springs, Colorado, or Medolas of Germany.
• Optical fiber 24 is preferably advanced at a rate that is coordinated with the power level and the frequency of pulsing of the laser.
• optical fiber 24 can be advanced at a rate of between about 0.125mm/sec (0.005 in/sec) to about 12.7mm/sec (0.5 in/sec) with a laser power level of about 10 mJ/mm 2 to about 60 mJ/mm 2 and a pulsing frequency of about 5 Hz to about 400 Hz.
• the optical fiber is advanced at a rate of about 0.75mm/sec to about 2.0mm/sec with a laser power level of between about 20mJ/mm 2 to about 40 mJ/mm 2 and a pulse frequency of about 30 to about 50Hz.
• the rate of advancement of the optical fiber is no greater than the rate of ablation of tissue in order to minimize mechanical tearing of body tissue by the fiber.
• advancing mechanism 68 can be set to advance optical fiber 24 at a rate greater than the ablation rate.
• optical fiber 24 is retracted back into handpiece 12 to reveal channel 80 formed within heart tissue 82 extending from epicardium 78 to myocardium 84.
• This step entails reversing the operation of advancing mechanism 68 to retract translation rod 72 to cause plunger mechanism 18 to return to its original position as shown by FIG. 8. This will cause optical fiber 24 to move proximally, thereby revealing channel 80 formed within heart tissue 82.
• coupler 10 can be removed laser generator 60 and discarded. The laser and the translation rod 72 are then cleaned and inspected for the next patient.
• Optical fiber coupler 10 in combination with the relatively quick and easy to use connection to the laser, provides a convenient and safe method of performing laser surgery.
• optical fiber 24 is inserted into a blood vessel 86 such that optical fiber 24 is positioned adjacent plaque obstruction 88 (FIG. 14), as is known in the art.
• Foot operated actuator 62 is actuated to initiate operation of the laser and the fiber advancing mechanism 68 to move fiber 24, in the direction indicated by arrow "A".
• optical fiber 24 ablates plaque 88 to produce channel 90 through the plaque obstruction 88.
• the rate of advancement of optical fiber 24 and the power level and frequency of pulsing of laser energy are coordinated, to form channel 80 through plaque 88.
• the rate of advancement of optical fiber 24 the user can ensure that plaque 88 is truly ablated by the laser energy and not just pushed aside. Ablation/removal of plaque 88 may reduce the likelihood of or delay restenosis as compared to mere mechanical manipulation of plaque 88.
• FIG. 17 illustrates the alternative optical fiber coupler shown generally at 100 connected to handpiece 102 via laser fiber sheath 104.
• Coupler 100 includes a housing 106, a plunger mechanism 108, an optical connector 110, and an opening 112 at a distal end for passage of an optical fiber 114 therethrough.
• optical fiber 114 is disposed within housing 106 with the proximal end traversing a first opening 116, a locking ring 118 disposed within compartment 120, and a second opening 122.
• Locking ring 118 firmly holds the proximal end of optical fiber 114 in the center of optical connector 110.
• Locking ring 118 is preferably made from rubber or a rubber-like material.
• Optical fiber 114 protrudes slightly from a cone 123 to become optically connected to a laser.
• plunger mechanism 108 preferably includes plunger 124, cylindrical drum 126, and spring 128.
• Optical fiber 114 enters cylindrical drum 126 through opening 130 (see also FIG. 20).
• Optical fiber 114 exits the cylindrical drum 126 through another opening 132 on distal face 134.
• Optical fiber 114 traverses spring 128 and enters sheath 104.
• An internally threaded bushing 136 is disposed at opening 112 of coupler 100 and threadingly receives sheath 104.
• Bushing 136 can be rotated to increase or decrease the effective length of sheath 104 between coupler 100 and handpiece 102. By adjusting the length of sheath 104, the relative distance between coupler 100 and handpiece 102 is adjustable.
• Optical connector 110 is a female connector similar to optical connector 20 shown by FIGS. 6 and 7 for optical fiber coupler 10.
• Optical connector 110 includes two backward "c" cut-outs 140 for matingly engaging an optical connector 142 of the laser as shown by FIG. 19. It is contemplated that fastening mechanisms can be used to further secure coupler 100 with the laser, such as thumb screws.
• Optical connector 110 and locking ring 118 prevent torque forces from adversely misaligning the optical fiber 114 and the laser output.
• Preferred materials for coupler 100 and related parts include biocompatible plastics, polymers and metals.
• Optical fiber coupler 100 can also be provided with a transponder chip, designated as TC in FIG. 18.
• transponder chip TC is preferably a glass embedded chip having contact recognition capabilities.
• a sending and receiving antenna may be associated with the laser unit to read and process information contained within the chip TC.
• information in the chip TC can include, for example, sterilization data, laser fiber and coupler information, including serial numbers associated with various parts and the like.
• Laser 150 is shown with a programmable computer 154 having a terminal 156 for storing instructions required to operate an advancing mechanism 158 within the laser for activating the plunger mechanism 108 of coupler 100.
• a toggle button 160 may be provided to switch from an operation mode to a test mode. In a particular test mode, when foot operated actuator is acted upon, optical fiber 114 is moved sequentially from a retracted position, to a predetermined extended position, and back to the retracted position.
• the advancing mechanism 158 of the laser includes translation rod 162 with proximal end 164 capable of engaging plunger 124 of optical fiber coupler 100 for advancing optical fiber 114 upon activation of the laser.
• rod 162 has a slot configured to receive the proximal end of plunger 124 as coupler 100 is rotated into engagement with the laser.
• optical fiber 114 can be a single fiber or an optical fiber bundle or other laser energy transmission mechanism. Most preferably, optical fiber 114 is a bundle of fibers having a collective diameter of about 1.2mm to about 1.6mm.
• Controlled longitudinal motion of the optical fiber 114 can be provided by one or more motors and preferably by one or more D.C. motors within the laser to distally move translation rod 162, thereby pushing plunger 124 distally to advance optical fiber 114 as further described below.
• stepper motors or other suitable drive mechanisms can be used.
• the laser can be either a continuous wave laser or a pulsed, high energy laser, such as, for example, an excimer, Yag, or an alexandrite laser.
• a pulsed high energy xenon chloride excimer laser is used, such as those available from Spectranetics of Colorado Springs, Colorado or Medolas of Germany.
• Optical fiber 114 is preferably advanced at a rate that is coordinated with the power level and the frequency of pulsing of the laser.
• optical fiber 114 can be advanced at a rate of between about 0.5mm/sec (0.02 in/sec) to about 12.7mm sec (0.5 in/sec) with a laser power level of about 10 mJ/mm 2 to about 60 mJ/mm 2 .and a pulsing frequency of about 5 Hz to about 400 Hz.
• the optical fiber 114 is advanced at a rate of about 0.75mm sec to about 2.0mm sec with a laser power level of between about 20mJ/mm 2 to about 40mJ/mm 2 and a pulse frequency of about 30 to about 50Hz.
• the rate of advancement of the optical fiber 114 is no greater than the rate of ablation of tissue in order to minimize mechanical tearing of body tissue by the fiber.
• the advancing mechanism 158 can be set to advance the optical fiber 114 at a rate greater than the ablation rate.
• optical fiber coupler 100 for understanding the operation of optical fiber coupler 100 in performing a TMR procedure.
• TMR magnetic resonance
• controlled advancement of the optical fiber 114 can be achieved as described above.
• the optical fiber 114 preferably will not penetrate the epicardium.
• optical fiber coupler 10 in conjunction with FIGS. 14-16 for understanding the operation of optical fiber coupler 100 in performing laser angioplasty.
• optical connector 110 and locking ring 118 prevent pull and torque forces from adversely misaligning the optical fiber 114 and the laser output to maintain approximately 100% transmission of the laser energy outputted from laser generator 150 through optical fiber 114.
• Locking ring 118 embedded and tightly secured within the molding of housing 106 functions to firmly hold optical fiber 114 in position and prevents pull and/or torque forces from misaligning fiber 114 from laser source 153. It is contemplated that other kinds of locking structure, besides a locking ring, can be used to prevent pull and/or torque forces from misaligning fiber 114 from laser source 153.
• the encoded optical fiber coupler designated generally by reference numeral 200 in FIG. 24 is similar to the optical fiber coupler described above with reference to FIGS. 1-16. Therefore, the same reference numerals are used to describe the various components of encoded optical fiber coupler 200 and its corresponding control module (FIG. 26). In addition, it is contemplated that the optical fiber coupler described above in conjunction with FIGS. 17-23 can be modified to include the encoding mechanisms described hereinbelow.
• coupler 200 is connected to a handpiece 12 via a sheath 14.
• Encoded optical fiber coupler 200 includes a housing 16, a plunger mechanism 18, an optical connector 20, and a magnetic stripe 202 at a top surface 23 of the housing 16 for storing information relating to an optical fiber 24 housed within the housing 16.
• coupler 200 With reference to FIG. 25, the components of coupler 200 are shown. Reference is to be made to the description provided above with respect to coupler 10 in conjunction with FIG. 2, for an understanding of how the components are assembled and interconnected.
• Transponder chip TC is preferably a glass embedded chip having contact recognition capabilities.
• a sending and receiving antenna may be associated with the laser unit to read and process information contained within the chip TC.
• Information in the chip TC can include, for example, sterilization data, laser fiber and coupler information, including serial numbers associated with various parts and the like. It is also contemplated to include the information in the chip TC to the magnetic stripe, such that the chip TC can function as a backup source for the information stored in the magnetic stripe, and vice versa.
• magnetic stripe 202 aligns with a magnetic stripe read/write assembly 206 having a read head (not shown) and a write head (not shown) for reading information stored within stripe 202 and writing information to the stripe 202 relating to the optical fiber 24 (FIG. 27).
• stripe read/write assembly 206 is capable of recording magnetic data onto magnetic stripe 202 and of converting magnetic data previously recorded on magnetic stripe 202 into digital information that can be operated upon by internal circuitry to display data on a terminal or to control the operation of coupler 200.
• Stripe read write assembly 206 is designed to encode data onto magnetic stripe 202 in straight line data paths using the edge of housing 16 as a guide so that the data paths are parallel to one edge of the housing 16.
• Assembly 206 may use f ⁇ ction type, motor driven rollers to drive housing 16 into and out of housing intake enclosure 208 and includes an edge guide 210 (FIG. 28) to maintain the proper orientation of stripe 202 within assembly 206.
• the reading and writing operations are performed in assembly 206 by driving stripe 202 along the stationary magnetic heads or by driving the heads over stripe 202 by means of a screw shaft once housing 16 is properly inserted within laser energy generator 204.
• laser energy source engages the proximal end of optical fiber 24 to transmit laser energy to optical fiber 24.
• Laser energy is transmitted upon activation of laser energy generator 204 as described above with respect to laser generator 60 shown by FIG. 3.
• Laser generator 204 is shown in FIGS. 26 and 27 with a programmable computer 64 having a terminal 66 for storing instructions required to operate advancing mechanism 68 within laser energy generator 204 for activating plunger mechanism 18 of coupler 200. Terminal 66 can also be used to display information read from stripe 202 or information to be written to stripe 202.
• terminal 66 may display recommendations to the surgeon regarding the specific optical fiber 24 housed within coupler 200, such as the number of additional times laser energy generator 204 can be fired with the specific encoded optical fiber coupler 200 connected thereto.
• translation rod 72 is advanced distally to engage and push plunger 40.
• Plunger 40 thus moves cylindrical drum 42 distally thereby advancing optical fiber 24 through the distal end of handpiece 12.
• the surgeon or operator can use a depth selector 76 on laser generator 204 to select the desired depth optical fiber 24 will feed into the body tissue.
• a first alternate embodiment of the encoded optical fiber coupler will now be described with reference to FIGS. 29-33.
• Encoded optical fiber coupler is designated generally by reference numeral 220 and includes a housing 222 having three elongated plates 224, 226 and 228 which are held together by screws 230.
• Plate 226 includes a cut-out portion 232 in alignment with a major bore 234 and a minor bore 236.
• Optical fiber 238 traverses cut-out portion 232, the major bore 234 and the minor bore 236 and exits housing 222.
• a magnetic stripe 240 is included on a bottom surface 242 (FIG. 31) of housing 222 for storing and writing information thereto relating to the optical fiber 238.
• a laser generator is shown designated generally by reference numeral 244.
• Generator 244 includes a foot operated actuator 246, a laser source 248, and an optical fiber advancement mechanism 250.
• Foot operated actuator 246 activates fiber advancement mechanism 250 and laser source 248 when it is depressed.
• laser generator 244 operates substantially similar to laser generator 60 other than having a different optical fiber advancement mechanism.
• laser generator 244 is capable of suspending operation of foot operated actuator 246, if it is determined, for example, by generator 244 that optical fiber 238 has sufficiently penetrated body tissue.
• laser generator 244 can be programmed to control the motors or similar advancing structure of optical fiber advancement mechanism 250 to control the advancement of optical fiber 238 upon actuation of foot operated actuator 246.
• Laser generator 244 is shown with a programmable computer 252 having a terminal 254 for storing instructions required to operate advancement mechanism 250. Terminal 254 can also be used to display information read from stripe 240 or information to be written to stripe 240. Additionally, terminal 254 may display recommendations to the surgeon regarding the specific optical fiber 238 housed within coupler 220, such as the number of additional times laser energy generator 244 can be fired with the specific encoded optical fiber coupler 220 connected thereto.
• Stripe read write assembly 260 is designed to encode data onto magnetic stripe 240 in straight line data paths using the edge of housing 222 as a guide so that the data paths are parallel to one edge of housing 222.
• Assembly 260 may use friction type, motor driven rollers to drive housing 222 into and out of slot 256 and includes edge guides 262 to maintain the proper orientation of stripe 240 within assembly 260.
• the reading and writing operations are performed in assembly 260 by driving stripe 240 along stationary magnetic heads (not shown) or by driving the heads over stripe 240 by means of a screw shaft once housing 222 is properly inserted within slot 256 and optically connected to laser energy generator 244.
• Coupler 300 includes an integrated circuit (IC) chip 302 on a bottom surface 304 (FIG. 35) of housing 306 for storing information relating to optical fiber 308.
• Housing 306 is similar to housing 222 of coupler 220 and further includes lateral edge guides 310 for guiding housing 306 along insertion tabs 312 within slot 314 of laser generator 316 (FIG. 36).
• a conductive surface 318 is included between insertion tabs 312 which engages IC chip 302 to electronically couple IC chip 302 to the inner circuitry of laser generator 316.
• the memory segment may include a ROM portion and a RAM portion.
• the ROM portion may store descriptive data of the optical fiber 308, such as fiber size and lot number.
• the RAM portion may store information which changes according to use, such as how many times the optical fiber 308 was used to transmit laser energy therethrough and the cumulative amount of time that laser energy was transmitted therethrough.
• Laser generator 316 operates substantially the same as laser generator 244.
• FIGS. 37-39 illustrate a third alternate embodiment of an encoded optical fiber coupler designated generally by reference numeral 350 having a bar code 352 (FIG. 38) for storing information indicative of an optical fiber (not shown) traversing sheath 14. It is noted that bar code 352 can be used to represent data which is descriptive of the optical fiber, such as lot number and fiber size. Bar code 352 is included on a bottom surface 356 of housing 358. Bar code 352 encodes data relating to the optical fiber in either or both of the relative widths of the bars 360 and spaces 362, and the relative heights of the bars 360.
• bar code 352 faces a bar code reading device 366 for reading the pre-printed bar code 352.
• Bar code reading device 366 captures .an electronic image of bar code 352 and forms a digital representation of the relative widths of the bars 360 and spaces 362 which can be displayed on a terminal and/or provided to a processor within laser generator 364 for subsequent processing.
• Charge coupled devices or laser based systems are generally used to capture a digital representation of the visual image of the entire bar code 352 and to perform a decode by analyzing the relative heights of the bars 360 and widths of the bars 360 and spaces 362 within the digitized representation as is known in the art.
• Encoded optical fiber couplers disclosed and described with reference to FIGS. 24-39 can be used to perform a TMR procedure as discussed above with respect to optical fiber coupler 10 in conjunction with FIGS. 10-13. Additionally, the encoded optical fiber couplers can be used to perform other cardiovascular procedures, for example, laser angioplasty as discussed above with respect to optical fiber coupler 10 in conjunction with FIGS. 14-16. It will be understood that various modifications can be made to the encoded optical fiber coupler embodiments disclosed herein. For example, additional devices may be used for storing information relating to the optical fiber besides a magnetic stripe, IC chip or bar code, such as a computer disk or a PCMCIA card which may store data relating to the coupler and not necessarily be attached to the coupler. It is also contemplated to have more than one information storage device and a combination of two or more storage devices for a particular coupler as indicated and shown by FIG. 25.
• Optical fiber advancing assembly 404 is of the type capable of precisely transmitting longitudinal motion to an optical fiber, optical fiber bundle or other laser energy transmission mechanism as described above with reference to FIG. 32.
• the controlled longitudinal motion can be provided by one or more motors and preferably by one or more stepper motors.
• Laser generator 402 may be either a continuous wave laser or a pulsed, high energy laser; such as, for example, an excimer, C02, Yag, or an alexandrite laser.
• TMR device 400 is designed to form channels from the endocardium towards an inner surface of the epicardium as discussed below.
• a difference between advancing assembly 404 and advancing mechanism 68, described above, is that the structure for advancing the fiber is external to the laser generator.
• lasers such as the Spectranetics CVX-300 excimer laser can be used with advancing assembly 404.
• Optical fiber advancing assembly 404 and laser source 405 are operably connected to function simultaneously.
• foot actuator see FIG. 32
• laser energy is transmitted through optical fiber 408 by laser source 405 while fiber advancing assembly 404 advances optical fiber 408 relative to handle portion 406.
• handle portion 406 includes housing 412 formed from molded housing half-sections 412a and 412b.
• Housing 412 includes a proximal, flexible sheath 414 for entry of optical fiber 408, an elongated body 416 preferably having a conical section 418 at one end, and an angled distal section 420 having approximately a 30-45° angle of curvature with respect to the longitudinal axis x-x of housing 412 extending from conical section 418.
• Housing half-sections 412a and 412b define a central bore 422, a proximal recess 424, and a distal recess 426.
• Proximal recess 424 is configured to receive a swivel connector 428 which is fastened to sheath 410.
• Locator ring 434 is provided at the distal end of angled section 420 for placement against a ventricle wall during a TMR procedure to facilitate proper orientation of handle portion 406 with respect to the heart tissue as shown by FIG. 46.
• Locator ring 434 can be formed integrally with housing half-sections 412a and 412b or can be removably fastened to angled section 420.
• a ridged surface 436 is formed on an outer wall of housing half-sections 412a and 412b to facilitate grasping of handle portion 406.
• the objective is to have the angled distal section 420 enter a ventricle 450 through the heart apex 452 to form one or more channels from the endocardium 454 to an inner surface of the epicardium 456. Entry through the apex can be achieved by incising the apex or through the use of a coring device, a preferred embodiment of which is described below.
• Advancement of fiber 408 may occur either continuously as laser energy is outputted, or in discrete steps. Once fiber 408 reaches the inner wall of the epicardium 456, it is withdrawn from the heart tissue, resulting in the channel 460 as shown in FIG. 48.
• Angled distal section 470 includes structure for penetrating the apex of the heart as well as providing a channel for the laser fiber.
• Angled distal section 470 includes a mechanical coring assembly 472 and a channel creating member 474, preferably an optical fiber.
• Tip member 514 is preferably made from stainless steel and functions to increase the surface area of the distal tip of flexible guide tube 510 when it comes in contact with tissue, thereby distributing forces .and reducing the likelihood of inadvertent tissue damage.
• Flexible guide tube is preferably fabricated from a shape memory alloy having an unrestricted curvature of about 90°. Suitable shape memory alloys include those fabricated from nickel and titanium and are available through Raychem Corporation, Menlo Park, California.
• the length of distal guiding portion 507, when straight and measured from the distal end of handle portion 502, is preferably from about 2 to about 6 inches, and most preferably about 4 inches, for open procedures, and from about 5 to about 10 inches, and most preferably about 7.5 inches, for thorascopic procedures.
• distal end 507 of handpiece 500 can be passed through an access port, such as cannula assembly 560 in FIGS. 61 and 62.
• Suitable cannula assemblies are known in the art and generally include a housing 562, an elongate tube extending distally from the housing 564, an insufflation port 566 and a seal 568.
• Cannula assembly 560 is placed in the body to provide access to a desired location.
• the distal tip of handpiece 500 is brought into contact with the heart, preferably against the epicardium 600 in the vicinity of the left ventricle 602. Manipulation of control knob 512 can help achieve the desired placement.
• FIG. 65 An open TMR procedure using handpiece 500 is generally shown in FIG. 65.
• the working end of the instrument is manipulated, as described above, within an open incision to facilitate placement of a laser fiber against the patient's heart.
• TMR channels are formed as previously described.

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• 1998
  • 1998-09-24 AU AU10626/99A patent/AU1062699A/en not_active Abandoned
  • 1998-09-24 CA CA002304188A patent/CA2304188A1/en not_active Abandoned
  • 1998-09-24 WO PCT/US1998/020204 patent/WO1999015237A1/en not_active Application Discontinuation
  • 1998-09-24 JP JP2000512603A patent/JP2001517508A/ja active Pending
  • 1998-09-24 EP EP98953194A patent/EP1017451A1/de not_active Withdrawn

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