1. Field of the Invention. The present invention relates to devices and methods for resecting and removing tissue from the interior of a patient's body, for example in a transurethral resection of prostate tissue to treat benign prostatic hyperplasia.
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 through a cutting window. Most such electrosurgical tissue cutting devices rely on manually engaging the cutting window 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 and field of view, the target tissue can be difficult to visualize prior to resection and, in particular, it can be difficult to assure that the optimum target site has been engaged by the cutting window. For these reasons, it would be desirable to provide improved electrosurgical cutting tools having improved visibility and ability to engage and immobilize tissue prior to cutting and to extract the tissue from tools after cutting.
US2017/0105748, commonly owned with the present application and incorporated herein by reference herein, describes an improved electrosurgical cutting device comprising an elongated shaft having a central axis, a distal end, and an outer surface. An offset housing is mounted on the distal of the shaft and has a tissue-receiving window. The tissue-receiving window is offset radially outwardly from the outer surface of the shaft, and a moveable electrode is configured to oscillate back and forth across the window to resect tissue which extends into the window. The offset housing improves visibility of the cutting window when viewed from endoscopes and other visualization apparatus.
While a substantial improvement over earlier electrosurgical cutting devices, the moveable electrode of the device of US2017/0105748 has a free distal end that is free-floating and which in rare instances can be caught by tissue and be lifted away from the ceramic housing. In other rare instances, the wire-like shaft of the devices of US2017/0105748 can potentially twist to an unwanted degree when the electrode engaged dense tissue.
For these reasons, it would be desirable to provide improved electrosurgical cutting devices, of the type generally taught in US2017/0105748, where the motion of the moveable electrode is more stabilized and the shaft is less prone to twisting. At least some of these objectives will be met by the inventions described below.
2. Description of the Background Art. US2017/0105748 has been discussed above. Other related patents and published applications include U.S. Pat. No. 8,221,404; U.S. Pat. No. 7,744,595; U.S. Pat. Publ. 2014/0336643; U.S. Pat. Publ. 2010/0305565; U.S. Pat. Publ. 2007/0213704; U.S. Pat. Publ. 2009/0270849; and U.S. Pat. Publ. 2013/0090642.
The present invention provides improved devices and methods for resecting tissue. Devices according to the present invention include an elongated member having a ceramic or other housing at its distal end. The elongated member typically has an axial lumen extending between distal and proximal ends, and the lumen typically receives a rotatable shaft having a distal end which terminates near the window in the housing and a proximal end which is configured to connect to a motor, typically located in a handle at a proximal end of the elongated member. A moveable electrode is coupled to a distal end of the rotatable shaft, and the electrode usually comprises an active portion which is radially offset from a central axis of the rotatable shaft so that rotational oscillation of the rotatable shaft causes the active portion to reciprocate, i.e. sweep back-and-forth, across the window in the housing.
In a first aspect of the present invention, the rotatable shaft comprises a tubular member having sufficient torsional strength or “stiffness” to resist twisting of the shaft while it is being rotationally oscillated or otherwise driven by the motor. In particular, the tubular member may comprise a rigid typically metal tube, usually having an insulative (electrically insulating) outer surface, often comprising a stainless steel tube covered by the insulated outer coating, sleeve, or the like. In more specific examples, the insultive outer surface may comprise a heat shrink polymer.
It has been found that a tubular member, typically a stainless steeled tubular member, having a wall thickness of at least about 0.005 in., more typically at least about 0.010 in., will be sufficient to provide torsional strength necessary to resist twisting of the shaft during motor driven movement.
In other specific aspects of this first example of the tissue resecting device of the present invention, the moveable electrode will have an active portion that extends across the tissue-receiving window with a profile that is substantially smaller than the window area. In this way, the active portion of the electrode will still leave a sufficient cross-sectional area of the window open to permit fluid aspiration around and past the active portion of the electrode even while the electrode is moving relative to the window.
In still further specific examples of this first example of the tissue resecting device, the motor may be configured to drive the active portion of the electrode at an oscillatory rate equal to or greater than 1 cycle per second (CPS) relative to the window. In many instances, the oscillatory rate will be equal to or great than 5 CPS relative to the window.
In still further specific aspects of this tissue resecting device, the active portion of the electrode may be offset outwardly from an axis of the rotatable electrode shaft by a distance of at least 2 mm, often by a length of at least 4 mm.
In a second aspect or example of the present invention, a tissue resecting device comprises an elongated member having a proximal end and a distal end. A housing is located at the distal end of the elongated member, and the housing has a tissue-receiving window through a side portion or wall thereof. Both the elongated member and the housing are typically hollow and have lumens therethrough where the lumen in the elongated member is aligned with the lumen in the housing. In this way, a continuous path is formed from the window in the housing to the proximal end of the elongated member. A rotatable shaft extends axially through the elongated member, typically through the lumen thereof, from the proximal end to the distal end of the housing. A movable electrode is coupled to a distal end of the rotatable shaft. A means for constraining the movable electrode is provided so that the electrode will move across the window in a fixed path as the rotatable shaft is rotated.
In a first specific embodiment, the means for constraining the movable electrode comprises a constraining channel located adjacent to a distal end of the window in the housing. A distal tip of the movable electrode travels in the constraining channel as the rotatable shaft is rotationally oscillated about its axis. Typically, at least an active of the movable electrode is radially offset from a rotational axis of the rotatable shaft. The constraining channel will usually have an arcuate path with a radius equal to the distance of the radial offset, and in this way the active portion of the electrode is able to track in the constraining channel as it is rotationally oscillated.
In such specific embodiments where the distal tip follows in a constraining channel, the movable electrode is usually a continuous element with a “dogleg” shape with one end attached to the elongated member and a free end (the distal tip) traveling in the constraining channel. By “dogleg” shape, it is meant that the movable electrode will have a first straight portion disposed along an axis and an active portion radially offset from the first straight portion. The active portion will usually be aligned with the first straight portion along a parallel axis. The active portion will usually also be straight, but in other instances could be slightly curve or have irregular profiles. A lateral portion or segment of the movable electrode joins the first straight portion and the active portion so that the movable electrode is an integrated structure capable of conducing electricity, typically being an electrically conductive metal. At least the active portion of the movable electrode will be exposed to engage or contact tissue and deliver electrosurgical current, usually a cutting current, while other portions not intended to contact tissue may be covered with an insulating sleeve or other material.
In a second specific embodiment, the constraining means may comprise a fixed pivot in a distal end of the housing where the pivot is axially aligned with an axis of the rotatable shaft. A distal tip of the movable electrode is axially aligned with the axis of the rotatable shaft and is rotatably coupled to the fixed pivot, and the active portion of the movable electrode is radially offset from the axis of the rotatable shaft, usually being formed with U-shaped deflection in a continuous metal element. A forward or free end of such the rotatable shaft can be rotatably coupled to the fixed pivot in order to constrain movement of the active portion of the movable electrode as the rotatable shaft is rotated. In particular, the active portion of the movable electrode will circumscribe an arcuate path with a center of rotation defined by the axis of the rotatable member. The arcuate path will usually span the entire width of the window and in some instances will extend beyond the sides or lateral edges of the window. The span of arcuate travel will usually be at least 5°, more usually being at least 10°, and frequently being in the range from 5° to 60°, often from 10° to 40°.
Such tissue resecting devices will usually further comprise a motor configured to rotationally oscillate the rotatable shaft in order to move the electrode. The motor will typically be located in a handle permanently or removable attached to a proximal end of the elongated member. For example, the movable electrode may be adapted to move or reciprocate from side-to-side across the window. The motor drive may be further configured to oscillate the active portion of the electrode at a rate greater than or equal to 1 CPS and the window on the housing may be radially offset outwardly from the outer surface of the elongate member by at least 2 mm, frequently by at least 4 mm.
The window in the ceramic or the housing may have two laterally spaced-apart edges or sides, where the movable electrode may further have a range of movement that extends the active portion thereof past these sides of the windows. Such sides of the windows may alternatively or additionally include ledges for receiving the electrode.
All embodiments of the present invention will usually be configured to be attached to a negative pressure or vacuum source to in order to extract resected tissue through tissue extraction lumens in the elongated member and the housing. Usually but not necessarily, the rotatable shaft will also be located at least partially in such tissue extraction lumens, but in other instances the rotatable shaft may be located in separate lumen(s) in the elongated member and the housing.
As will be described below and shown in
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More in particular, referring to
In contrast,
Second, the offset housing 140 is adapted for resecting tissue to a greater depth in a localized region of an organ, rather than resecting surface tissues over a broad area. More in particular as shown in
As can be further be seen in
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In general, the window 144 in housing 140 can be configured to have a radial arc relative to the electrode shaft 176 ranging between 30° and 180°. In one variation of housing 140′ shown in
Now turning back to
After the introducer sleeve assembly 102 is used for an initial diagnostic procedure, the endoscope 130 can be removed from the assembly 102 and connector 205 can be disconnected from handle body 205. Thereafter, the sleeve portion 240 (see
Now turning to
In another aspect of the invention shown in
In general, a tissue resecting device corresponding to the invention comprises an elongated member extending along a longitudinal axis to a distal portion having a window communicating with an aspiration source, an electrode having an electrode shaft with a central axis extending within the elongated member to an electrode working end wherein a portion of the electrode working end is offset from said central axis, and a motor configured to rotate the electrode shaft to cause the electrode working end to move relative to the window wherein the electrode shaft comprises a tubular member adapted to resist twisting of said shaft during motor driven movement thereof. Further, the tubular member can comprise a metal tube with an insulative outer surface layer 282. The tissue tubular member can be a stainless steel tube with the insulative outer surface layer comprising a heat shrink polymer.
In one variation, the electrode's working end has a profile that is substantially smaller than the area of the window to thereby permit fluid aspiration around the electrode working end at all times through the window as the electrode is moving relative to the window. This allows the negative pressure source to draw the tissue into the window interface, and maintains the tissue in the interface as the electrode cuts and extracts the resected tissue. In one variation, the electrode working end is motor driven and moves at a rate of equal to or greater than 1 CPS relative to the window, or equal to or greater than 5 CPS relative to the window. As described previously, the electrode working end can be offset radially outward from the shaft assembly by at least 2 mm or by at least 4 mm.
In another aspect of the invention, the tissue resecting device comprises an elongated member extending to a distal housing having a tissue-receiving window, a moveable electrode configured to move across the window, and a motor configured to move the electrode wherein a distal tip of the electrode moves in a constraining channel in the housing. In another variation, the tissue resecting device comprises an elongated member extending to a distal housing having a tissue- receiving window, a moveable electrode configured to move across the window; and a motor configured to move the electrode wherein a distal end of the electrode is non-free floating or pivots in a pivot channel.
This application claims the benefit of provisional application No. 62/340,445 (Attorney Docket No. 42005-707.101), filed on May 23, 2016, the full disclosure of which is incorporated herein by reference.
Number | Date | Country | |
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62340445 | May 2016 | US |