Abstract:
A distal end of an introducer sheath into a patient&#39;s urethra is advanced into a patient&#39;s urethra while flowing an irrigation fluid through a lumen and out a distal end of the introducer sheath into the urethra. The irrigation fluid is simultaneously removed from the urethra through the distal end and lumen of the introducer sheath to establish a circulation of the irrigation fluid in the urethra as the introducer sheath is advanced. The urethra may then be viewed through an endoscope positioned in the lumen of the introducer sheath as the irrigation fluid circulation is continued. A unitary connector is detachably coupled to a proximal end of the elongated sleeve, and a fluid seal is disposed between the unitary connector and the proximal end of the elongated sleeve. The unitary connector is configured to connect the first and second channels to the inflow pump and the outflow pump, respectively.

Description:
CROSS-REFERENCE TO RELATED APPLICATIONS 
       [0001]    This application claims the benefit of Provisional No. 62/242,519 (Attorney Docket No. 42005-706.101), filed Oct. 16, 2015, the entire content of which is incorporated herein by reference. 
     
    
     BACKGROUND OF THE INVENTION 
     Field of the Invention 
       [0002]    The present invention relates to devices and methods for resecting and removing tissue from the interior of a patient&#39;s body, for example in a transurethral resection of prostate tissue to treat benign prostatic hyperplasia. 
         [0003]    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. 
         [0004]    For resection of remote tissue sites, such as the prostate, it is usually desireable to introduce the surgical cutter through a tubular introducer device. Which such tubular introducers can be advanced “blind,” i.e. without direct optical visualization, it is frequently desirable to prove such direct visualization. For example, it would be desirable to use an endoscope to observe the urethra while transurethrally advancing an introducer sheath for subsequent resection of the prostrate. Once the introducer sheath is in place, however, it will be necessary to advance the cutter through the introducer sheath which can require that fluid recirculation pumps be disconnected from the introducer sheath and reconnected to the surgical cutter. Such an exchange can be time consuming, and often the surgical cutter will require a different pumps and/or or pump interface than does the introducer sheath. 
         [0005]    For these reasons, it would be desirable to provide improved urethral and other introducers for use with electrosurgical cutting tools. It would be particularly desirable if the introducer sheaths were easily connectable to and disconnectable from a pumping and control system that can be used both for initial advancement of the introducer sheath and for subsequent connection of the surgical cutter or other surgical tool. At least some of these objectives will be met by the inventions described below. 
         [0006]    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. 
       SUMMARY OF THE INVENTION 
       [0007]    In a first aspect of the present invention, an optical introducer system comprises an elongated sleeve having an endoscope-receiving passageway and first and second channels extending therethrough. A unitary connector is detachably coupled to a proximal end of the elongated sleeve, and a fluid seal is disposed between the unitary connector and the proximal end of the elongated sleeve. The unitary connector is configured to connect the first and second channels to an inflow pump and an outflow pump, respectively. 
         [0008]    In specific embodiments, the unitary connector may include a first isolated flow channels for flowing irrigation fluid from the inflow pump to the elongated sleeve and a second isolated flow channel for removing irrigation fluid from the elongated sleeve. The unitary connecter typically further comprises a body and a detachable conduit having one end configured to be coupled to the inflow pump and the outflow pump and another end configured to be removably attached to the body. A third channel may be provided in the elongated sleeve for fluidic communication with a pressure sensor, and the optical introducer system may further comprise a controller operatively coupled to the inflow pump, the outflow pump and the pressure sensor. The controller may also house the inflow pump and the outflow pump, and the conduit may be extendable from the controller to the body, where the conduit includes a third isolated channel for connecting the third channel in the elongated sleeve to the controller. The elongated sleeve may have a fourth channel configured to removably receive a shaft of a diagnostic or therapeutic tool. The fourth channel is typically configured to removably receive a tissue resecting device, where the tissue resecting device may be a mechanical resecting device, an electrosurgical resecting device, or other device. The elongated sleeve may have a proximal end adapted for coupling to a tissue resecting device and may be dimensioned for trans-urethral access to a patient&#39;s prostate and/or bladder. The first, second and third channels typically have a mean diameter of at least 1 mm. 
         [0009]    In a first aspect of the present invention, a method for positioning an introducer sheath into a patient&#39;s urethra comprises advancing a distal end of the introducer sheath into the patient&#39;s urethra, flowing an irrigation fluid through a lumen and out a distal end of the introducer sheath into the urethra, and simultaneously removing the irrigation fluid from the urethra through the distal end and lumen of the introducer sheath to establish a circulation of the irrigation fluid in the urethra as the introducer sheath is advanced. The urethra may then be viewed through an endoscope positioned in the lumen of the introducer sheath as the irrigation fluid circulation is continued. 
         [0010]    In specific embodiments, the irrigation fluid may be pumped with at least one pump to flow into the urethra and to simultaneously removing the irrigation fluid from the urethra. More typically, however, the irrigation fluid will be pumped into the urethra with an inflow pump and will be aspirated from the urethra with an outflow pump. The inflow pump typically communicates with an inflow channel in the sheath and the outflow pump typically communicates with an outflow channel in the sheath. The inflow and outflow pumps may be connected to the introducer sheath by a unitary connector which is detachably attached to a proximal end of the introducer sheath. The methods may further comprise detaching the unitary connector from the introducer sheath and attaching a resection device to a proximal end of the introducer sheath. The resection device is typically inserted through the introducer sheath while said sheath remains in the patient&#39;s urethra. Fluid pressure in the urethra may be measured with a pressure sensor operatively coupled to the sheath where the pressure sensor may communicate through an independent flow channel in the sheath. Typically, the inflow pump and outflow pump are controlled to control pressure in the urethra. 
     
    
     
       BRIEF DESCRIPTION OF DRAWINGS 
         [0011]      FIG. 1  is a view of a tissue resecting device and a block diagram of systems and operating components corresponding to the invention. 
           [0012]      FIG. 2  is a perspective view of the working end of the resecting device of  FIG. 1  showing an asymmetric ceramic housing and moving electrode that is adapted to sweep across a tissue-receiving window. 
           [0013]      FIG. 3  is another perspective view of the working end of  FIG. 2  from a different angle. 
           [0014]      FIG. 4A  is a schematic view of the working end of  FIGS. 2-3  interfacing with tissue targeted for resection under endoscopic vision. 
           [0015]      FIG. 4B  is a schematic view of a working end of a prior art tubular cutting device used in a hypothetical resection procedure. 
           [0016]      FIG. 5  is another schematic view of the working end of  FIGS. 2-3  being used to resect targeted tissue to a significant depth from the organ surface. 
           [0017]      FIG. 6  is a perspective view of a distal dielectric housing of a working end similar to that of  FIGS. 2-3  showing window sides with ledges for receiving the electrode at the ends of its movement in a sweeping arc. 
           [0018]      FIG. 7A  is a schematic view of a method of the invention wherein an endoscope is inserted into the introducer assembly and a conduit is coupled to the introducer assembly to couple flow channels therein to a controller with an inflow pump and an outflow pump, wherein  FIG. 7A  then illustrates the step of introducing the introducer assembly into a patient&#39;s urethra to access the prostate under endoscopic vision and continuous flow irrigation. 
           [0019]      FIG. 7B  illustrates a subsequent step wherein the endoscope is withdrawn from the introducer assembly and then handle of the introducer assembly is detached from a sleeve portion and the sleeve portion remains in place to access a site in the patient&#39;s prostate. 
           [0020]      FIG. 7C  illustrates a further subsequent step wherein the endoscope inserted into the resecting device, which then is inserted into sleeve portion remaining in the patient to access the treatment site in the prostate or bladder, and the conduit can be coupled to the resecting device either before or after its insertion through the sleeve portion. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0021]      FIG. 1  illustrates an electrosurgical tissue resecting system  100  for use in urological procedures to resect tissue that includes an introducer sleeve or sheath  102  and a hand-held single-use tissue resecting device or probe  105 . The resecting device  105  has a handle portion  108  that is coupled to an elongated shaft or extension portion  110  that has an outer diameter ranging from about 2 mm to 7 mm, and in one variation is 5 mm in diameter. The shaft  110  extends about longitudinal axis  112  to a working end  115  that is radially asymmetric relative the shaft  110  and its axis  112  as further described below. In one variation, the device is adapted for performing a TURP procedure (transurethral resection of prostate) or a bladder tumor resection procedure and thus the shaft portion  110  extends about axis  112  with a length suitable for introducing in a transurethral approach to reach the targeted prostate tissue or bladder tissue. 
         [0022]    As will be described below and shown in  FIG. 1 , the resecting device  105  is adapted for introduction through the introducer sleeve  102 . Such an introducer sleeve  102  is adapted to receive a commercially available endoscope  130  as can be understood from  FIG. 1 . 
         [0023]    Referring to  FIGS. 1-3 , in general, it can be seen the resecting device  105  has an elongated shaft  110  that extends to a distal shaft portion  132  that is coupled to an offset resecting housing  140  that has an offset tissue-receiving window  144 . A moveable electrode  145  is adapted to be driven by a motor drive unit  148  in handle  108  (see  FIG. 1 ) so that the longitudinal portion  149  of the electrode  145  sweeps across the window  144  from side to side to electrosurgically resect tissue that is captured in the window  144 . The targeted tissue can be suctioned into and captured in window  144  by means of a negative pressure source or outflow pump  150  in controller  155  that communicates with a tissue extraction channel  158  extending through the device  105  and terminating in the window  144 . 
         [0024]    More in particular, referring to  FIGS. 2 and 3 , the configuration of the offset housing  140  is adapted to perform multiple functions. First, the offset housing  140  positions the window surface WS (within curved plane P indicated in  FIG. 2 ) outwardly from the outer surface  160  of shaft  110  which then allows the window surface WS to be fully visible through a endoscope  130  or other viewing means that would be introduced parallel to the device shaft  110  (see  FIG. 4A ). For example,  FIG. 4A  is a schematic view of the working end  115  with working surface WS in contact with targeted tissue T. As can be seen in  FIG. 4A , the endoscope  130  is positioned with the field of view FV directly aligned with the working surface WS thus allowing optimal viewing of the tissue resection process. 
         [0025]    In contrast,  FIG. 4B  shows a working end  115 ′ of a conventional dual sleeve tubular cutter having a window surface WS′ which when pressed against an organ prevents endoscopic vision of the interface between the tubular cutting edge and the tissue T during a resection procedure. 
         [0026]    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  FIG. 5 , the offset portion  170  of housing  140  can be pushed into tissue perpendicular to axis  112  of the probe shaft  110 . Thus, as shown in  FIG. 5 , the offset housing  140  can be used to resect tissue deep into in a localized region that would not be possible with a resecting device having the configuration shown in  FIG. 4B . 
         [0027]      FIGS. 2 and 3  illustrate the asymmetric or offset dielectric housing  140  that can comprise a ceramic material such as zirconium oxide, aluminum oxide or similar materials as is known in the art. In  FIGS. 2-3 , it can be seen that window surface WS is offset from the shaft surface  160  by a predetermined dimension D which can be from 2 mm to 8 mm and in one embodiment comprises a 5 mm offset. 
         [0028]    As can be further be seen in  FIGS. 2-3 , the width W of the window surface WS around at least portions of the perimeter of the window  144  is a limited dimension, for example less than 3 mm, or less than 2 mm or less than 1 mm. which allows the offset portion  170  of housing  140  to be pushed into tissue perpendicular to the device axis  112  as the electrode  145  sweeps across the window  144 . 
         [0029]    Referring to  FIGS. 2-3 , one variation of resecting device  105  has an electrode  145  that can be tungsten or stainless steel wire that with electrode portion  149  adapted to sweep across the window  144  at any suitable rate, for example from 1 Hz to 500 Hz. In  FIG. 3 , it can be understood that the electrode  145  has an elongated proximal shaft portion  176  that extends into handle  108  of the device ( FIG. 1 ). The proximal end of electrode  145  is operatively coupled to a motor drive unit  148  and a suitable mechanism or controller is provided to rotate the elongated electrode shaft portion  176  in an arc to resect tissue. 
         [0030]    As can be understood from  FIGS. 2-3 , the electrode portion  149  moves back and forth akin to a windshield wiper across window  144  in the offset housing  140 . A number of mechanisms can be used to effectuate the desired movements of the electrode, or the motor drive  148  simply can be controlled by software to move in intermittent clockwise and counter-clockwise directions. In one variation, the elongated proximal portion  176  of the electrode  145  will twist over its length and thus the motor drive  148  can be adapted to rotate the electrode shaft in an arc with radial angle which is greater than the window&#39;s comparable radial angle or arc. Thus, the electrode portion  149  can be expected to move back and forth entirely across the window even when meeting some tissue resistance by compensating for some twisting that is allowed in the proximal electrode shaft portion  176 . In one variation, the motor drive unit can be adapted to over-rotate the electrode shaft portion  176  at its proximal end by a selected amount which can be from 10° radial motion to 90° radial motion to compensate for twisting of the electrode shaft portion to insure that electrode portion  149  sweeps entirely across the surface of window  144 . 
         [0031]    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  FIG. 6 , it can be seen that the electrode portion  149  has a range of motion that extends across the radial dimension of the window  144  to ensure that any tissue captured in the window is resected as the electrode portion  149  passes the window edges  182   a  and  182   b  to function like a shear or in a scissor-like manner. The electrode portion  149  moves over ledges  186   a  and  186   b  on either side of the housing  140 ′ and can bump into surfaces  190   a  and  190   b.  By bumping into the surfaces  190   a  and  190   b,  any over rotation in the electrode shaft  176  to accommodate twisting as described above can limit the rotation of the electrode portion in the housing  140 ′. Further, in  FIG. 6 , it can be seen that the distal tip  192  of electrode portion  149  extends distally beyond window  144  and onto distal ledge  194  in the housing  140 ′ to ensure tissue is resected by the electrode in the distal window region. 
         [0032]    Now turning back to  FIG. 1 , it can be understood that the resecting device  105  and endoscope  130  can be used with introducer sleeve assembly or sheath  102 . As shown in  FIG. 1 , the introducer assembly  102  has a proximal handle body  202  with a connector  204  that is adapted to couple to connector member  205 . The connector  205  is adapted to couple a conduit  206  to controller  155  and provide within a single cable the following: (i) a first lumen communicating with the fluid outflow pump  150 , (ii) a second lumen communicating with a fluid inflow pump  225 , and (iii) a third lumen communicating with a pressure sensor positioned in the controller  155  or in or near the connector  205 . As can be seen in  FIG. 1 , the introducer sleeve  102  can also accommodate an endoscope  130 . Thus, the introducer sleeve  120  can be assembled with the endoscope  130  (and without the resection device  105 ) and coupled by connector  205  to the controller  155  to provide an inflow of irrigation fluid from fluid source  226 , and outflow of irrigation fluid to collection reservoir  228  together with pressure sensing to allow the assembly to be used in a diagnostic procedure prior to a tissue resection procedure. In other words, the introducer sleeve  102  can function as a ‘continuous flow’ optical introducer for use in trans-urethral access to a targeted sire in the prostate or bladder. 
         [0033]    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  FIG. 1 ) of introducer assembly  102  can be detached from proximal handle body  204  with the sleeve portion  240  remaining in the patient. Next, the endoscope  130  and connector  205  can be assembled with the resecting device  105  and the physician can insert the resecting device  105  through the sleeve portion  240  remaining in the patient to access the targeted site. The resecting device  105  and sleeve portion  204  in combination then provide lumens as described above for fluid inflows, fluid outflows and direct pressure sensing through lumens in connector  205 . 
         [0034]    The method of using the introducer assembly is shown in more detail in  FIGS. 7A-7C . More in particular,  FIG. 7A  illustrates the endoscope  130  inserted into the introducer assembly  102  and conduit  206  being coupled to the introducer assembly  102  to couple the inflow and outflow channels to controller  155  to provide a continuous inflow and outflow at the distal end  252  of sleeve portion  240 .  FIG. 7A  further illustrates the step of introducing the introducer assembly  102  into a patient&#39;s urethra  255  to access the prostate  260  or bladder  275  under endoscopic vision and continuous flow irrigation. 
         [0035]      FIG. 7B  illustrates a subsequent step wherein the endoscope  130  is withdrawn from the introducer assembly  102  and then the handle  202  of introducer assembly  102  is detached from a sleeve portion  240  and the sleeve portion  240  remains in place to access a site in the patient&#39;s prostate  260 . As can be seen in  FIG. 7B , the proximal end  264  of sleeve portion  240  is configured with a body  265  and at least one seal member  270  such as an o-ring to provide a fluidic seal when mated with receiving connector portion  272  in handle  202 . 
         [0036]      FIG. 7C  illustrates a further subsequent step wherein the endoscope  130  inserted into the resecting device  105 , and thereafter the assembly of the resecting device  105  and endoscope are inserted into sleeve portion  240  remaining in the patient to access the treatment site in the prostate  206  or bladder  275 . The proximal body  265  of sleeve portion with it seal member  270  then mates with a receiving channel in the resecting device handle to provide a fluidic seal. The conduit  206  can be coupled to the resecting device  105  which has a receiving connector  204  similar to that of introducer assembly handle  202 . In use, the system then provides for continuous flow irrigation and extraction of fluid and tissue chips through the resecting device. 
         [0037]    In another variation, the introducer sleeve assembly  102  can include a removable blunt tip obturator that can assist in atraumatic insertion into a patient&#39;s urethra. 
         [0038]    Referring to  FIGS. 2-3 , one variation of the resecting device as described above has an electrode  145  with a resecting portion  149  that moves radially in an arc relative to axis  112  and a distal window  144 . Another variation can provide an electrode  145  that reciprocates axially to move across the window  144  and would have similar effectiveness. 
         [0039]    Referring back to  FIG. 1 , the electrode  145  comprises a first polarity electrode or active electrode and the shaft portion indicated that  245  comprises the return electrode. 
         [0040]    Referring to  FIG. 1 , the resecting device  105  can be actuated by moveable finger grip  260  which is adapted to be squeezed toward fixed finger grip  262  to thus move the working end  115  and window surface WS axially back and forth to resect tissue. The physician can activate the electrosurgical function with a foot switch  265  ( FIG. 1 ) and then reciprocate the working end  115  back and forth from about 5 mm to 25 mm to resect tissue in a path. At the same time, the physician can slightly rotate the shaft of the resecting device  105  so that the window surface WS engages a wider path in the targeted tissue surface. 
         [0041]    In typical use, the physician would stabilize the sleeve portion  240  and endoscope  130 , and then reciprocate and slightly rotate the resecting device  105  during a tissue resection procedure. During such a procedure, the physician can also slightly rotate the sleeve  240  and endoscope  130  to optimize viewing of the targeted tissue.