Surgery – Instruments – Electrical application
Reexamination Certificate
2002-09-30
2004-12-07
Peffley, Michael (Department: 3739)
Surgery
Instruments
Electrical application
C606S027000, C607S099000, C607S101000, C607S116000
Reexamination Certificate
active
06827716
ABSTRACT:
BACKGROUND OF THE INVENTION
U.S. Pat. No. 6,277,112, assigned to Arthrocare (“Underwood”), discloses methods for therapeutically applying electrical energy to tissue within a patient's spine, including introducing an active electrode into the patient's spine, positioning an active electrode near a target tissue, and applying a high voltage across the electrode to produce a plasma to volumetrically remove, ablate or coagulate the target tissue.
Underwood also discloses methods for therapeutically treating a patient's knee, and discloses that the insertion of the probe is usually guided by an arthroscope that includes a light source and a video camera to allow the surgeon to selectively visualize a zone within the knee joint. See Underwood at col. 31, lines 6-9.
U.S. Pat. No. 6,264,650, also assigned to Arthrocare (“Hovda”), discloses methods for therapeutically applying electrical energy to tissue within a patient's spine, including introducing an active electrode into the patient's spine, positioning an active electrode near a target tissue, and applying a high voltage across the electrode to produce a plasma to volumetrically remove, ablate or coagulate the target tissue.
Hovda further discloses that “the system may include an endoscope with a fiber optic headlight for viewing the surgical site, and that the endoscope may be intergral with the therapeutic probe or part of a separate instrument. See Hovda at col. 21, lines 22-25. Hovda does not teach how this headlight is used. Hovda appears to distinguish between the surgical site (i.e., the entire disc) and the target site (i.e., the tissue to be treated). Therefore, Hovda does not specifically disclose using the headlight to identify a pathologic region within a target tissue.
In sum, Hovda discloses therapeutic devices and optical devices, but does not teach that the optical device can be used to identity a pathologic region within a target tissue.
U.S. Pat. No. 6,095,149 (“Sharkey”) discloses a method of treating interverterbal discs by using a flexible catheter to position a functional element within the disc. Sharkey discloses functional elements including any element capable of aiding diagnosis, delivering energy, or delivering or removing a material from a location adjacent the element's location in the catheter, such as an opening in the catheter for delivery of a fluid or for suction, a thermal energy delivery device (heat source), a mechanical grasping tool for removing or depositing a solid, a cutting tool (which includes all similar operations, such as puncturing), a sensor for measurement of a function (such as electrical resistance, temperature or mechanical strength), or a functional element having a combination of these elements. See Sharkey at col. 14, lines 43-54.
Sharkey further discloses that a variety of different materials can also be delivered to the disc, including electrolyte solutions via the catheter and/or introducer to the disc. Sharkey discloses that the electrolyte solution helps the physician view the disc. See Sharkey at col. 21-22.
Sharkey discloses that the catheter is positionable to selected sites near the annulus fibrosus for the delivery of therapeutic and/or diagnostic agents including but not limited to electromagnetic energy, electrolyte solutions, and contrast media and thermal energy. See Sharkey at col. 15, lines 45-52.
The only elements capable of aiding diagnosis actually specified by Sharkey are contrast agents. These contrast agents are typically detected by fluoroscopy. Sharkey does not disclose diagnostic elements upon the probe that actively detect a pathologic region within a target tissue.
Moreover, although Sharkey discloses diagnostic elements, energy delivery elements, and six other functional elements, and combinations thereof, Sharkey does not disclose the specific combination of a diagnostic element and an energy delivery element, nor an optical diagnostic element.
U.S. Pat. No. 6,015,406 (“Goble”) discloses an electrode-containing electrosurgical instrument for treating tissue in the presence of an electrically-conductive fluid (“ECF”) medium. Goble discloses that the procedure may be used for thermal shrinkage of joint capsules, for discectomy either in the treatment of disc prolapse or as part of a spinal fusion via a posterior or anterior approach to the spine. Goble at col. 4, lines 52-57. Goble further discloses that the procedures may include simultaneous viewing of the site via an endoscope or using an indirect visualization means. See Goble at col. 5, lines 24-26.
Goble does not teach using the endoscope to identify pathologic tissue.
In sum, conventional methods for therapeutically treating interveterbral discs do not also teach using a probe having an element that actively senses the pathologic region of the disc prior to treatment.
U.S. Pat. No. 5,941,834 (“Skladnev”) discloses a probe for identifying different tissue types within body canals such as the endocervical canal. The probe comprises optical and electrode measuring systems disposed on opposite sides of a cylinder, wherein the systems are designed for taking optical and electrical measurements simultaneously on the same area of tissue. Sladnev discloses that probes using optical fibers are temperature sensitive.
Skladnev does not discloses a probe having a therapeutic functional element, nor a probe suitable for entering an intervertebral disc.
U.S. Pat. No. 5,976,076 discloses a stereo laparoscope for producing a stereoscopic optical image of an intracorporal region to be viewed through a small incision. Kolff does not disclose a probe having a therapeutic functional element.
U.S. Pat. No. 6,004,262 (“Putz”) discloses a surgical device comprising a probe having a fiber optic strand disposed at its distal end, and electrode wires. In one method of using the device, the “seeing eye” optical strand visually guides the assembly to the epidural space of the spinal column, and the electrode wires either monitor electrical activity at the site or stimulate tissue at the site.
Neither Skladnev, nor Kollf, nor Putz discloses a probe having a therapeutic functional element, nor a probe suitable for entering an intervertebral disc.
SUMMARY OF THE INVENTION
The present invention relates to using a “see and treat” system to better assess and treat a pathologic region within an intervertebral disc. In particular, the present invention relates to a method of treatment comprising a first step wherein a diagnostic element is positioned adjacent or within the disc and provides information to the clinician that allows the clinician to identify a pathologic region of the disc. In a second step, a therapeutic element treats the identified pathologic region.
By improving localization of the pathologic regions with the diagnostic element, the therapy may be more accurately delivered, and so should have a higher chance of success.
Because the present invention provides for localized treatment, the clinician disrupts the target tissue only where necessary, thereby preserving healthy tissue. Because the present invention allows diagnosis and treatment to be coupled, the treatment is done immediately after diagnosis, thereby saving time.
Therefore, in accordance with the present invention, there is provided a method of therapeutically treating an intervertebral disc having a pathologic region, the method comprising the steps of:
a) positioning a probe having a diagnostic element within or adjacent to the disc,
b) activating the diagnostic element to identify the pathologic region, and
c) therapeutically treating the identified pathologic region.
Also in accordance with the present invention, there is provided a method of therapeutically treating an intervertebral disc having a pathologic region, the method comprising the steps of:
a) positioning a probe having a diagnostic element and a therapeutic element within or adjacent to the disc, the diagnostic element comprising a sensor and an active element,
b) transmitting energy through the active element to target tissue to produce a signal fr
Reynolds Martin A.
Ryan Thomas P.
Serhan Hassan
Depuy Spine, Inc.
DiMauro Thomas M.
Peffley Michael
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