TISSUE RESECTING DEVICES AND METHODS
A tissue-resecting probe includes an elongated outer sleeve extending about an axis to a distal housing having a first window for receiving tissue. An edge of the first window has a dielectric surface. A rotatable inner sleeve has a second window, and at least a portion of an edge of the second window provides a first polarity electrode. Rotation of the inner sleeve within the outer sleeve moves the probe between window-open and window-closed configurations to resect tissue.
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This application is a continuation of U.S. patent application Ser. No. 14/275,603 (Attorney Docket No. 42005-704.201), filed May 12, 2014, now U.S. Pat. No. ______, which claims the benefit of U.S. Provisional Application No. 61/821,936 (Attorney Docket No. 42005-704.101), filed May 10, 2013, the entire content of which is incorporated herein by reference.
BACKGROUND OF THE INVENTION 1. Field of the InventionThe present invention relates to systems and methods for resecting and extracting tissue in arthroscopy and other fields.
Electrosurgical cutting devices often comprise a shaft or sleeve having a tissue extraction lumen with one or more radio frequency (RF) cutting blades arranged to resect tissue which may then be drawn into the extraction lumen, often via vacuum assistance. Most such electrosurgical tissue cutting devices rely on manually engaging the electrode or other tissue-cutting edge against the target tissue to be resected. While such manual engagement is often sufficient, in other cases, such as in laparoscopic procedures having limited access, the target tissue can be difficult to immobilize prior to resection. For these reasons, it would be desirable to provide improved electrosurgical cutting tools having the ability to engage and immobilize tissue prior to cutting.
2. Description of the Background ArtRelated patents and applications include U.S. Pat. No. 8,221,404; U.S. Pat. No. 7,744,595; U.S. 2010/0305565; U.S. 2007/0213704; U.S. 2009/0270849; and U.S. 2013/0090642.
SUMMARY OF THE INVENTIONIn a first aspect of the present invention, a tissue-resecting probe comprises an elongated outer sleeve extending about an axis to a distal housing having a first window for receiving tissue. An edge of the first window has a dielectric surface. A rotatable inner sleeve has a second window wherein at least a portion of an edge of the second window comprises a first polarity electrode and wherein rotation of the inner sleeve within the outer sleeve moves the probe between window-open and window-closed configurations to resect tissue.
The edge of the second window usually includes a plurality of openings and bridges between the first polarity electrode, and a portion of the inner sleeve that has dielectric surfaces. A proximal edge of the second window typically has a dielectric surface, and a lateral edge of the second window comprises the first polarity electrode. In some embodiments, both lateral edges of the second window comprise the first polarity electrode.
In other embodiments, a lateral edge of the second window has a dielectric surface, and a distal edge of the second window may at least partly comprise the first polarity electrode. In still other specific embodiments, the first polarity electrode is symmetric about the second window relative to said axis, and in still other embodiments, the first polarity electrode is asymmetric about the second window relative to said axis. In still further specific aspects, the edge of the second window includes a plurality of openings and bridges between the first polarity electrode and a portion of the inner sleeve having dielectric surfaces, wherein the cumulative length of the openings parallel to the edge of the second window is typically at least 50% of the length of said first polarity electrode about the edge of the second window.
Further optionally, a portion of the outer sleeve may comprise a second polarity electrode, and a negative pressure source may be placed in communication with an interior passageway in the inner sleeve.
In a second aspect of the present invention, a tissue-resecting probe comprises an elongated probe including a windowed outer sleeve and cooperating windowed inner sleeve that is rotatable to resect tissue. An edge of the inner sleeve window comprises a first polarity electrode and a portion of the outer sleeve comprises a second polarity electrode. A controller and electrical source are operatively connected to the first and second electrodes, and the controller is configured to activate the electrodes only during part of each 360° rotation of the inner sleeve.
The controller is usually configured to activate the electrodes during 90° to 180° rotation of each 360° rotation of the inner sleeve. Optionally, the controller is configured to activate the electrodes only when an advancing edge of the inner sleeve window is exposed in the outer sleeve window. In such embodiments, a microswitch is configured for actuation during each 360° rotation of the inner sleeve, wherein the controller activates and de-activates the electrodes in response to signals from the microswitch, and the controller optionally activates and de-activates the electrodes in response to a measured electrical parameter, typically impedance, relative to electrodes that varies during each 360° rotation of the inner sleeve.
In a third aspect of the present invention, a tissue-resecting probe comprises an elongated probe having a windowed outer sleeve and a cooperating windowed inner sleeve that is rotatable to resect tissue. An edge of the inner sleeve window comprises a first polarity electrode and a portion of the outer sleeve comprises a second polarity electrode. A controller and electrical source are operatively connected to the first and second electrodes, and the controller is configured to receive user inputs to stop the inner sleeve rotationally relative to the outer sleeve in at least first and second positions.
In said first position, the tissue-resecting probe aligns the outer and inner sleeve windows to provide an open window configuration. In said second position, the outer and inner sleeve windows are not aligned, providing a partly open window configuration.
A microswitch is configured for actuation during each 360° rotation of the inner sleeve, and the controller includes an algorithm to stop the inner sleeve rotationally in the first or second positions in response to a signal from the microswitch. The controller includes an algorithm to stop the inner sleeve rotationally in the first or second positions in response to a measured electrical parameter, typically impedance, relative to electrodes that varies during each 360° rotation of the inner sleeve.
In a fourth aspect of the present invention, a tissue-resecting probe comprises an elongated probe including a windowed outer sleeve and a cooperating windowed inner sleeve that is rotatable to resect tissue, wherein an edge of the inner sleeve window comprises a first polarity electrode and a portion of the outer sleeve comprises a second polarity electrode. A motor probe for rotating the inner sleeve is disposed within a handle, and a slip couples between a motor shaft and the inner sleeve. The slip may comprise at least one belt and acts as a clutch which slips if resistance to rotation of the inner sleeve exceeds a predetermined level. A controller and electrical source may be provided for operating the motor and for energizing the electrodes. An exemplary controller operates with an algorithm for detecting electrical parameters of the motor indicative of slipping of the slip coupling.
The algorithm may be further configured to de-energize the electrodes upon detection of slipping of the slip coupling.
In a fifth aspect, a method for fabricating an electrosurgical component including an electrically conductive core covered by thin polymeric insulating coating comprises providing a metal core having an external metal surface. A plurality of adherence features are created over at least a portion of the external metal surface, wherein the adherence features include undercuts. A polymeric insulating layer is formed over the external surface wherein the polymer extends beneath the undercuts to enhance adherence of the polymeric insulating layer to the external metal surface.
The creating step typically includes at least one of metal or ceramic sputtering, metal spraying, and electroless plating under conditions selected to apply discrete metal features and not apply a continuous metal film. Optionally, the creating step may also include drilling, e.g. laser drilling, to provide the undercut features. Alternatively, the creating step may include at least one of sandblasting and burnishing. Usually, the metal core is formed at least partially from stainless steel, and the polymeric insulating layer is composed at least partially of a FEP (fluorinated ethylene propylene) or a PFA (perfluoroalkoxy). The polymeric insulating layer is often formed to have a thickness in the range of 0.001 inch to 0.05 inch.
In a sixth aspect of the present invention, a tissue-resecting probe comprises an elongated probe comprising a windowed outer sleeve and cooperating windowed inner sleeve that is rotatable to resect tissue, wherein an edge of the inner sleeve window comprises a first polarity electrode and a portion of the outer sleeve comprises a second polarity electrode. A controller is configured to control a negative pressure source in communication with a passageway in the inner sleeve, wherein the controller is configured to activate the negative pressure source only during part of each 360° rotation of the inner sleeve.
The controller is typically configured to activate the negative pressure source during 30° to 180° rotation of each 360° rotation of the inner sleeve.
In a seventh aspect of the present invention, a tissue-resecting probe comprises an elongated probe having a working end with a windowed outer sleeve and cooperating windowed inner sleeve that is rotatable to resect tissue, wherein an edge of the inner sleeve window comprises a first polarity electrode and a portion of the outer sleeve comprises a second polarity electrode. At least one port is formed in the outer sleeve of the working end, and a moveable member has a first position that permits fluid flow through the at least one port and a second position that prevents fluid flow through the at least one port.
The outer sleeve usually has a plurality of ports and the moveable member is moveable between a plurality of positions to permit fluid flow through one or more ports.
In an eighth aspect of the present invention, a tissue-resecting probe comprises an elongated probe including a windowed outer sleeve and a cooperating windowed inner sleeve that is rotatable to resect tissue. An edge of the inner sleeve window comprises a first polarity electrode and a portion of the outer sleeve comprises a second polarity electrode. A motor is attached to move the inner sleeve, and an electrical source is operatively connected to the first and second electrodes. A pressure source is in communication with a passageway in the inner sleeve, and a controller controls the motor, the electrical source and the pressure source, and the controller is configured to selectively provide negative pressure or positive pressure to the interior passageway.
The controller is usually configured to receive user input to select negative pressure or positive pressure. For example, the controller may be configured to receive a signal of an operational parameter of the motor to select negative pressure or positive pressure. Alternatively, the controller may be configured to receive a pressure signal from a pressure sensor to select negative pressure or positive pressure. The controller could also be configured to de-activate the first and second electrodes in response to a signal of an operational parameter of the motor or be configured to de-activate the first and second electrodes in response to a pressure signal from a pressure sensor. As another option, the controller may be configured to de-activate the first and second electrodes in response to selection of a negative pressure or positive pressure applied to the interior passageway.
In a ninth aspect of the present invention, a tissue-resecting probe comprises an elongated outer sleeve extending about an axis to a distal housing having a first window for receiving tissue. An edge of the first window has a dielectric surface, and a rotatable inner sleeve has a second window wherein at least a portion of an edge of the second window comprises a first polarity electrode having a surface area of less than 0.02 sq. in., less than 0.01 sq. in. or less than 0.005 sq. in.
Referring to
The tissue resecting probe 100 of
Referring now to
Now turning to
In
An electric DC motor 142 is housed with the handle with motor shaft 186 having a pulley 188 that carries at least one flexible belt 190 for rotating the inner sleeve 122. The inner sleeve 122 has pulley 192 that engages the belts 190 which can be fabricated of rubber, Viton® or the like. The DC motor can be geared (together with pulleys 188 and 192) to drive the inner sleeve 122 at from 500 to 5000 rpm and in one embodiment is 900 rpm. The motor 142 an has electrical cable 194 extending therefrom to the controller 145 and a DC electrical source 195.
In one aspect of the invention, the at least one flexible belt 190 is adapted to slip in the event that rotation of inner sleeve 122 is met with excessive resistance during a procedure, for example which could occur when the inner sleeve 122 is resecting very dense tissue or when the inner sleeve 122 comes into contact with bone. In another variation, the controller 145 also can have an algorithm that continuously receives signals from a sensor mechanism that signals the controller of the actual rpm of the inner sleeve 122 during use, and the algorithm further can de-energize the electrode arrangement if rotation of the inner sleeve 122 stalls or slows to a predetermined low cut-off speed, such as below 100 rpm, 200 rpm, or 300 rpm. The algorithm can further provide for re-energizing the electrode arrangement if the inner sleeve 122 regains a predetermined rpm above the cut-off speed, which could occur when the physician moves or re-adjusts the working end relative to dense tissue or bone that had impeded rotation. In one embodiment, the sensor mechanism for determining rpm of the inner sleeve 122 comprises a microswitch 196 shown in
As can be seen in
Now turning to another aspect of the invention,
In another variation and method similar to that described with reference to
Now turning to
In another variation, the controller 145 can have an algorithm adapted to energize and de-energize the electrodes (150, 175) on each revolution of the inner sleeve 122 in bore 168 of outer sleeve 112. More in particular, in the working end embodiment of
In another embodiment, a tissue resecting probe can use signals from the microswitch 196 (
In another variation, the controller 145 can have an algorithm adapted to modulate negative pressure in the tissue extraction channel 146 upon each revolution of the inner sleeve 122 in bore 168 of outer sleeve 112. In one method, the negative pressure source 135 is actuated for the interval in which leading edge 160a of inner sleeve 122 is exposed and energized as the electrode 150 advances past the edge of window 120 in outer sleeve 112 and for the following 180° of rotation until leading edge 160a advances to a window-closed position. During the following 180° of rotation, the negative pressure source 135 can be turned off or can operate at a lower setting. This aspect of the invention allows for a high level of negative pressure for suctioning tissue into the window and a lower level of negative pressure at other times. In another variation, the higher level of negative pressure for suctioning tissue into the window can occur for an interval, for example 10° to 90° of rotation before the leading edge 160a of inner sleeve 122 is exposed and advances past the edge of window 120 in outer sleeve 112, again to suction tissue into the window.
In
As a further optional feature, the variation of
In another aspect of the invention relating to
Claims
1. A tissue-resecting probe comprising:
- an elongated outer sleeve extending about an axis to a distal housing having a first window for receiving tissue, wherein an edge of the first window has a dielectric surface; and
- a rotatable inner sleeve having a second window wherein the inner sleeve carries a first polarity electrode and wherein rotation of the inner sleeve within the outer sleeve moves the probe between window-open and window-closed configurations to resect tissue;
- a motor for rotating the inner sleeve;
- a controller for controlling the motor, wherein the controller is configured to de-activate the first electrodes in response to a signal of an operational parameter of the motor.
2. The tissue-resecting probe of claim wherein an edge of the second window comprises the first polarity electrode.
3. The tissue-resecting probe of claim 2 wherein a lateral edge of the second window comprises the first polarity electrode.
4. The tissue-resecting probe of claim 2 wherein both lateral edges of the second window comprise the first polarity electrode.
5. The tissue-resecting probe of claim 1 further comprising a negative pressure source in communication with an interior passageway in the inner sleeve.
6. The tissue-resecting probe of claim 5 wherein the controller is operatively connected to the negative pressure source
7. A tissue-resecting probe comprising:
- an elongated probe comprising a windowed outer sleeve and cooperating windowed inner sleeve that is rotatable to resect tissue, wherein an edge of the inner sleeve window comprises a first polarity electrode and a portion of the outer sleeve comprises a second polarity electrode;
- a motor for rotating the inner sleeve; and
- a controller and electrical source operatively connected to the first and second electrodes, wherein the controller is configured to de-activate the first and second electrodes in response to a signal of an operational parameter of the motor.
8. The tissue-resecting probe of claim 7 wherein the controller is configured to activate the electrodes during 90° to 180° rotation of each 360° rotation of the inner sleeve.
9. The tissue-resecting probe of claim 7 wherein the controller is configured to activate the electrodes only when an advancing edge of the inner sleeve window is exposed in the outer sleeve window.
10. The tissue-resecting probe of claim 7 further comprising a microswitch configured for actuation during each 360° rotation of the inner sleeve, wherein the controller activates and de-activates the electrodes in response to signals from the microswitch.
11. The tissue-resecting probe of claim 7 wherein the controller activates and de-activates the electrodes in response to measured electrical parameter relative to electrodes that varies during each 360° rotation of the inner sleeve.
12. The tissue-resecting probe of claim 11 wherein the electrical parameter is impedance.
13. A tissue-resecting probe comprising:
- an elongated probe comprising a windowed outer sleeve and cooperating windowed inner sleeve that is rotatable to resect tissue, wherein an edge of the inner sleeve window comprises a first polarity electrode and a portion of the outer sleeve comprises a second polarity electrode;
- a motor for moving the inner sleeve; and
- a controller and electrical source operatively connected to the motor and to the first and second electrodes, wherein the controller is configured to receive stop rotation of the motor and the inner sleeve relative to the outer sleeve in at least a first position.
14. The tissue-resecting probe of claim 13 wherein said first position comprises alignment of the outer and inner sleeve windows to provide a window-open configuration.
15. The tissue-resecting probe of claim 14 wherein the controller is configured to receive to stop rotation of the motor and the inner sleeve in a second position comprising non-alignment of the outer and inner sleeve windows to provide a partly window-open configuration.
16. The tissue-resecting probe of claim 15 wherein the controller includes an algorithm to stop the inner sleeve rotationally in the first or second positions in response to a signal from a mechanism configured to monitor rotation of the inner sleeve.
17. The tissue-resecting probe of claim 13 wherein the controller includes an algorithm to stop the inner sleeve rotationally in the first or second positions in response to a measured electrical parameter relative to electrodes that varies during each 360° rotation of the inner sleeve.
18. The tissue-resecting probe of claim 17 wherein the electrical parameter is impedance.
Type: Application
Filed: Jun 5, 2018
Publication Date: Oct 4, 2018
Applicant: Corinth MedTech, Inc. (Cupertino, CA)
Inventors: Benedek Orczy-Timko (Budapest), Csaba Truckai (Saratoga, CA), Aaron Germain (San Jose, CA)
Application Number: 16/000,127