Claims for Patent: 8,152,796

Summary for Patent: 8,152,796

Title:	Method and apparatus for performing percutaneous laser disc decompression with vaporization monitoring by fluid displacement
Abstract:	Apparatus and method of performing percutaneous laser spinal disc decompression with the patient retaining consciousness. The clear plastic hub of a discectomy needle has a translucent hub with a chamber which is filled with a saline solution prior to insertion of an optical fiber of a laser apparatus through the needle. Gas production from the vaporization of the nucleus of the disc by the optical fiber of the laser apparatus forms bubbles in the water or saline fluid interface thereby providing the physician with an indication of the rate of vaporization of the disc nucleus. In addition, the detection of gas bubbles in an awake, responsive patent facilitates (a) determining the appropriate amount of laser energy required, (b) confirmation of disc vaporization, (c) following the course of laser surgery, and (d) minimizing the potential for laser associated patient injury.
Inventor(s):	McMillan; Marion R. (Seneca, SC)
Assignee:
Application Number:	11/699,527
Patent Claims:	1. Apparatus for performing lumbar and cervical disc nucleus vaporization using laser energy, comprising: a needle assembly including an elongated hollow needle of predetermined interior diameter having an open proximal end and an open distal end and a translucent needle hub to which said proximal end of said needle is rigidly secured including a chamber in fluid communication with said open proximal end of said needle and having an opening adapted for communication with the atmosphere, a needle stylette removable from said needle, a variable intensity and variable duration laser delivery system including an optical fiber having a exterior diameter smaller than the interior diameter of said hollow needle so as to be insertable through the interior of said hollow needle, and so as to allow for vapor passage, and an adjustable optical fiber depth limiting device operable to select the length of optical fiber extending from said distal end of said needle and a saline solution in said chamber of said needle hub through which bubbles of vapor created by laser vaporization of said nucleus pass and are visibly observable by an attendant physician. 2. The apparatus of claim 1 wherein said needle is not larger than a 20 gauge needle. 3. The apparatus of claim 1 wherein said distal end of said needle is bent 10 degrees to provide a one centimeter long curved tip. 4. The apparatus of claim 3 including a visible marker on a radial side of said needle hub corresponding to the radial direction in which the distal end of said needle is bent. 5. The apparatus of claim 1 wherein said optical fiber is a 0.400 millimeter diameter quartz rod with a plastic coating having a 0.500 millimeter outside diameter. 6. A method of performing percutaneous laser spinal disc decompression comprising the steps of: providing a laser energy source, providing a styletted needle which has transparent hub with an open chamber at its proximal end, providing a variable intensity and variable duration laser delivery apparatus including a laser fiber with an adjustable compression nut, said laser fiber having a diameter smaller than the inside diameter of said styletted needle, providing an optical laser fiber, calibrating the optical laser fiber preoperatively to determine its optical transmission characteristics, with the stylette removed from the needle, placing the laser fiber in the needle and adjust the compression nut on the fiber so that the fiber extends between 1 mm and 5 mm from the distal end of the needle when the nut abuts the hub, using fluoroscopic guidance, placing the distal end of the styletted needle into the nucleus of a herniated or degenerated spinal disc of a patient under local anesthesia with conscious patent sedation permitting continuous verbal communication, removing stylette from the needle, placing a transparent fluid in the cavity of the hub of the needle, inserting the optical fiber of the laser delivery apparatus through the proximal end of the needle, adjusting the compression nut so that the optical fiber extends from 1 mm to 5 mm from the distal end of the needle when the nut rests on the hub of the needle, operating the laser apparatus to apply sufficient laser energy to the nucleus of the spinal disc to cause tissue vaporization, regulating the intensity and duration of the application of laser energy by observing bubble formation in the fluid filled chamber of the transparent needle hub and by verbal communication with the conscious patient. 7. A method of performing percutaneous laser spinal disc decompression, comprising the steps of providing a laser energy source, providing a variable intensity laser delivery apparatus including an optical fiber with a locking nut, providing a styletted needle having a tip at its distal end and a transparent hub with an open chamber at its proximal end, adjusting the locking nut so that the optical fiber projects between 1 mm and 5 mm from the distal end of the needle when the optical fiber is inserted herein with the locking nut abutting the transparent hub, preparing a human patient for a surgical procedure during which the patient retains consciousness, locating the disc to be treated using at least two fluoroscopic images, calibrating the optical laser fiber to verify its optical transmission characteristics prior to the start of the laser procedure, inserting the distal end of the styletted needle into the located disc with the distal end lying in the disc nucleus in a plane parallel to the long axis of the disc, removing the stylette, filling the hollow chamber of the transparent hub with a sterile water or saline liquid solution inserting the optical fiber through the needle projecting the end of said fiber 1 mm to 5 mm beyond the opening in the tip of the needle, delivering laser energy through the optical fiber to the disc nucleus, monitor the rate of vaporization of the nucleus by visibly observing vapor bubbles passing through the saline solution in the hollow chamber of the hub, and adjusting the laser energy delivery responsive to the observed rate of passage of the vapor bubbles passing through the saline solution and in response to patients verbal communication of experienced pain, delivering 30 to 70 vaporizing pulses producing 600 to 1600 total joules of laser energy to the disc nucleus by pulsed technique.

Details for Patent 8,152,796

Applicant	Tradename	Biologic Ingredient	Dosage Form	BLA	Approval Date	Patent No.	Expiredate
Merck Sharp & Dohme Corp.	ZOSTAVAX	zoster vaccine live	For Injection	125123	05/25/2006		2039-09-22