Abstract:
Systems and devices for resecting and removing tissue or organs from the interior of a patient&#39;s body, in a minimally invasive laparoscopic procedure while preventing any dispersion of potentially malignant tissue during the resection process.

Description:
RELATED APPLICATIONS 
       [0001]    This application claims is a non-provisional of U.S. Provisional Patent Application No. 62/189,008, filed on Jul. 6, 2015, the content of which is incorporated herein by reference in its entirety. 
     
    
     FIELD OF THE INVENTION 
       [0002]    The present invention relates to systems and devices for resecting and removing tissue or organs from the interior of a patient&#39;s body, in a minimally invasive laparoscopic procedure while preventing any dispersion of potentially malignant tissue during the resection process. 
       BACKGROUND 
       [0003]    Several surgical procedures require removing a tissue mass or an organ from the body of a patient in an efficient manner preventing dispersion of potentially malignant tissue during the resection process. One such procedures is a hysterectomy where a woman&#39;s uterus is detached and removed from her body. Hysterectomy is typically performed in cases of severe endometriosis, presence of fibroids, cancer, cervical dysplasia, uterine prolapse and more. With the advent of minimally invasive surgery such as laparoscopic surgery large tissue masses such as the uterus are removed through small incisions, decreasing post operative pain and hospitalization time. 
         [0004]    Several types of hysterectomy are performed fully or partially laparoscopically and these include Total Laparoscopic Hysterectomy (TLH) where the uterus and cervix are removed through few small incisions made in the abdomen; Laparoscopic Supracervical Hysterectomy (LSH) where the uterus is removed, but the cervix is left intact. In both cases the uterus is removed through one of the small incisions using an instrument called a morcellator. Another approach is a Total Vaginal Hysterectomy (TVH) where the uterus and/or cervix are removed through the vagina. 
         [0005]    In laparoscopic hysterectomies for example, the uterus is removed using instruments inserted through small tubes into the abdomen, resulting in few small incisions in the abdomen. A laparoscopic approach offers surgeons better visualization of affected structures (e.g. by using an endoscope) than either vaginal or abdominal hysterectomy. 
         [0006]    There remains a need to resecting and/or removing tissue from the interior of an organ while maintaining a surface of the organ to prevent tissue being removed from spreading within the body. Such procedures and devices require an ability for the medical practitioner to be aware of the position of the cutting device relative to the surface of the tissue of the organ while the device is within the organ. This would allow the physician to remove a significant portion of the tissue within the organ and remove the organ from the body. Such devices and systems can be used in any part of the body with a hysterectomy being one example. 
       SUMMARY 
       [0007]    The present disclosure includes systems and methods for resecting and/or removing tissue from the interior of an organ and monitoring a proximity of the tissue removal device to a surface of the organ to prevent the surface of the organ from being cut or breached by the cutting device. In some variations, the cutting device advances through the outer surface of the organ when inserted into a cavity within the organ. In alternate variations, the device is introduced through an opening of the organ. The devices and methods described herein are explained with respect to performing a hysterectomy. However, the methods, devices and systems can be used in any body location unless otherwise specifically claimed. 
         [0008]    In one example, the prevent disclosure teaches a system for resecting tissue within an interior of an organ. Such a variation can include a probe having a proximal portion and a distal portion; a cutting member configured to remove tissue and located at the distal portion of the probe; at least one sensor located adjacent to the cutting member, the sensor configured to generate a signal comprising an environmental condition adjacent to the cutting member; and a controller configured to receive the signal of the environmental signal and use the signal to determine whether the cutting member is adjacent to an exterior surface of the organ. 
         [0009]    The sensor can comprise a mechanism selected from a group consisting of: a capacitance sensing mechanism, an impedance sensing mechanism, an optical sensing mechanism, and an ultrasound mechanism. 
         [0010]    In one variation of the system, the controller is configured to generate an alert signal upon detecting that the cutting member is adjacent to the exterior surface of the organ. Such an alert signal can comprise an aural alert, a visible alert, a tactile alert, and a combination thereof. 
         [0011]    The probe and cutting mechanism can comprise a mechanical or an electrosurgical based cutting mechanism. In certain variations, the sensor is located adjacent to the cutting mechanism or adjacent to a window or opening in the probe that exposes the cutting member. 
         [0012]    In variations where the cutting mechanism comprises an electrosurgical cutting mechanism, the cutter can comprise an electrode element, a resistively heated element, an inductively heated element, an ultrasound transmission element and a light energy transmission element. 
         [0013]    The controller of the present system can include an algorithm for de-activating the cutting member in response to the signal that the cutting member is within a pre-determined proximity to the organ surface. The algorithm can also modulate the speed that the cutting member removes tissue. 
         [0014]    The systems described herein can further comprise a negative pressure source in fluid communication with the probe and cutting mechanism, where the negative pressure source extracts resected tissue through a passageway in the probe. Alternatively, or in combination, the systems can comprise a positive pressure source in fluid communication with the probe. 
         [0015]    The present disclosure also includes methods for resecting tissue. In one such variation, the method can comprise introducing a probe into an interior of an organ, wherein a working end of the probe includes a cutter and sensor mechanism adjacent to the cutter, where the sensor mechanism is configured to detect a surface of the organ; resecting tissue with the cutter generating a signal with the sensor mechanism when the sensor mechanism detects the cutter approaching the organ surface from the interior of the organ; and removing a substantial volume of the organ from within the interior of the organ without the cutter perforating the organ surface from the interior thereby preventing dispersion of potentially malignant tissue. 
         [0016]    The method can further include variations where the sensor mechanism comprises at least one of a capacitance sensing mechanism, an impedance sensing mechanism, an optical sensing mechanism and an ultrasound mechanism. In an additional variation, the sensor mechanism is operatively coupled to a controller to provide signals consisting of at least one of aural, visible or tactile signals. 
         [0017]    The method can also include a controller that employs an algorithm for de-activating the cutter in response to a signal that the cutter is within a pre-determined proximity to the organ surface. The de-activating step can comprise stopping movement of the cutter or stopping energy delivery to the cutter. In additional variations, the controller includes an algorithm for modulating the speed of movement of the cutter in response to a the signal that the cutter is within a pre-determined proximity to the organ surface. 
         [0018]    Variations of the method can also include mobilizing mobilizing the organ with the intact organ surface after the substantial volume is removed and removing the organ from the patient&#39;s body. 
         [0019]    In an additional variation, a method of resecting tissue comprises introducing a probe into an interior of an organ, wherein a probe working end includes a first sensor component; disposing a second sensor component at an exterior surface of the organ; and activating the probe to resect tissue wherein the first and second sensor components cooperate to provide at least one signal indicating a proximity of the probe to the exterior surface of the organ. At least one of the sensor components comprises a component selected from the group consisting of a capacitance sensing mechanism, an impedance sensing mechanism, an optical sensing mechanism and an ultrasound mechanism and the other sensor component cooperates to enhance a sensitivity of said signals. 
         [0020]    The sensor component can include a gas, liquid or gel disposed at the exterior of the organ. Alternatively, or in combination the second sensor component comprises a sac disposed at the exterior of the organ. 
         [0021]    In an additional variation, the present disclosure include a method for laparoscopic hysterectomy. For example, the method can include introducing a probe into a uterine cavity, wherein a probe working end includes a sensor mechanism for sensing the proximity of the cutter to an exterior surface of a uterine wall; activating the probe to resect tissue from within the uterine cavity wherein the sensor mechanism provides signals indicating the proximity of the cutter to said exterior surface; and removing a substantial volume of the tissue from within the uterine cavity without perforating the uterine wall thereby preventing dispersion of potentially malignant uterine tissue  29 . The method of claim  28  preceded by the step of sealing and/or ligating blood vessels communicating with the uterus. 
         [0022]    The method can further comprise removing a substantial volume of the tissue within the uterine cavity without perforating the uterine wall from within the cavity such that the uterine wall forms an intact shell. The method can also include transecting the shell of the uterine wall away from the patient&#39;s body. 
         [0023]    The methods and/or devices described herein can be performed in a supracervical procedure, a trans-vaginal approach, an endoscopic approach, or in an open surgical approach. 
         [0024]    In an additional variation, a method of resecting at least a portion of an organ can include isolating the tissue mass or organ from its blood supply; introducing a resecting probe into the organ, wherein a probe working end includes a cutter and sensor mechanism for sensing the proximity of the cutter to a surface of the organ; activating the cutter to resect tissue wherein the sensor mechanism provides signals indicating the proximity of the cutter to the organ surface; and removing a substantial volume of the organ without perforating the organ surface thereby preventing dispersion of potentially malignant tissue. 
     
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         [0025]    The disclosed variations will next be described in greater detail by reference to exemplary embodiments that are illustrated in the drawings. 
           [0026]      FIG. 1  is a schematic view of a tissue resection device and block diagram of operating components corresponding to the invention for use in a laparoscopic resection procedure. 
           [0027]      FIG. 2  is a perspective view of the working end of a resection device of the type shown in  FIG. 1  showing a sensor mechanism carried by the working end. 
           [0028]      FIG. 3A  is a schematic view of the patient&#39;s uterus and abdominal region showing initial steps of a laparoscopic hysterectomy procedure with an ultrasound component de-coupled from a resection device. The ultrasound component can optionally a plurality of piezoelectric elements carried therein. 
           [0029]      FIG. 3B  is a sagittal view of the patient&#39;s uterus and abdominal cavity showing another step comprising introducing a trocar through the uterine wall from the abdominal cavity. 
           [0030]      FIG. 3C  is a sagittal view of a step comprising introducing the resecting device into the interior of the uterus, actuating the device to reset tissue and removing tissue through passageway in the resecting device. 
           [0031]      FIG. 3D  is a sagittal view of a further step comprising introducing utilizing the resecting device to reset and remove a substantial volume of the interior of the uterus while sensor mechanisms indicate and/or control when a cutting member comes into proximity to the wall of the uterus. 
           [0032]      FIG. 4  is a sagittal view of the patient&#39;s uterus and abdominal cavity showing the variation in the method wherein a sensor responsive media is applied around the exterior surface of the uterus. 
           [0033]      FIG. 5  is another sagittal view of the patient&#39;s uterus and abdominal cavity showing another variation in the method wherein a sensor responsive mesh sac is disposed around the exterior surface of the uterus. 
       
    
    
     DETAILED DESCRIPTION OF THE INVENTION 
       [0034]      FIGS. 1 and 2  illustrate a tissue resection system  100  that includes a hand-held single-use tissue cutting device or resection device  105 . The device  105  has a handle portion  106  that is coupled to a shaft portion  110  having an outer diameter ranging from about 3 mm to 20 mm. The shaft portion  110  extends along axis  111  and can have a length suitable for introducing directly into a body space or into an organ, for example introducing though a trocar in a laparoscopic procedure or for introducing through a working channel of an endoscope. 
         [0035]    In one variation, a hand-held resecting device  105  as depicted in  FIGS. 1 and 2  can be used to perform a laparoscopic hysterectomy procedure as depicted in  FIGS. 3A to 3D . Referring to  FIGS. 1 and 2 , the resection device  105  is a tubular cutter as is known in the art with a shaft portion  110  and working end  112 . The shaft  110  comprises an assembly of a first or outer sleeve  115  extending along axis  111  to a distal end  116  having a window  118  therein for receiving tissue. A second or inner sleeve  125  with a distal blade edge  126  and distal opening  128  is dimensioned to rotate in bore  132  of outer sleeve  115 . The outer and inner sleeves,  115  and  125 , can be fabricated of thin-wall stainless steel but any other suitable materials can be used. As can be understood from  FIGS. 1-2 , rotation of the inner sleeve  125  will cut tissue captured in the window  118  of the outer sleeve.  FIG. 2  shows the working end  112  of the assembly of outer sleeve  115  and inner sleeve  125  with the inner sleeve  125  rotating and in a partially window-open position. 
         [0036]    As can be seen in  FIG. 1-2 , the resection system  100  can include a controller  140  that is adapted for (i) controlling a motor drive in the resecting device  105  as will be described below; (ii) controlling at least one sensor system carried by the resection device  105  that will be described further below, (iii) controlling a negative pressure source or outflow pump  150  operatively coupled to a tissue extraction channel  152  in the resection device  105 , and (iv) controlling an optional fluid source  155  and inflow pump  160  for distending or flooding a treatment site with a fluid, such as saline. 
         [0037]    Referring  FIG. 1 , the controller  140  includes algorithms for driving a motor  162  in the handle  106  of the resecting device  105 . The motor can be a brushless DC motor and controller  140  can be configured to operate the motor at a preset RPM or a user-selected RPM between 100 and 2,000 RPM.  FIG. 1  shows an electrical cable  166  extending from connector  168  in the controller  140  to the resecting device handle  106 . The resecting device  105  can be operated by a switch  170  in the handle  106  or a footswitch indicated that  174  coupled to the controller  140 . 
         [0038]    Still referring to  FIG. 1 , the controller  140  includes a roller pump  150  that provides a negative pressure source for extracting tissue through the passageway  152  in the resecting device  105 . The roller pump  150  in combination with the flexible tubing  176  is configured to pump fluid and extracted tissue chips through the tubing into the collection reservoir  178 . 
         [0039]    Again referring to  FIG. 1 , controller  140  can have a second roller pump  160  adapted to provide fluid flows into a site targeted for resection. A fluid source  155  is coupled to a flexible fluid infusion tubing  182  that is engaged by the roller pump  160  and that further extends to a fitting  187  on cannula  190  which is adapted for access to the treatment site. The cannula  190  can inserted into the site and can be used as an access pathway for the resection device  105  or the cannula can be used for fluid infusion independent of the resection device. In another variation, the fluid infusion tubing  182  can be coupled to the resection device  105  so that fluid flows to the working end  112  and window  118  in a path in the annular space between the outer sleeve  115  and the inner sleeve  125 . 
         [0040]    Now turning to  FIG. 2 , the working end  112  of the resecting device  105  is shown in an enlarged perspective view. In one variation shown in  FIG. 2 , a sensor system is shown disposed around the cutting window  118  in the working end. This variation shows four capacitance sensors  210  disposed around the window  118  which comprise the distal termination of paired wire leads as is known in the art capacitance sensors. The capacitance sensors  210  are coupled to the controller  140  through cable  214  ( FIG. 1 ). The sensors  210  can be carried in a thin polymeric coating  220  on the outer sleeve  125 . In this embodiment, there are four capacitance sensors, but there could be from 1 to 20 sensors on the outer sleeve  125 . In another variation, one or more capacitance sensors could be carried on the inner sleeve surface opposing the sharp blade edges. As will be described below, capacitive sensors  210  can provide a signal to the user when the cutting blade  126  ( FIG. 2 ) approaches the periphery of an organ targeted for resection. While  FIG. 2  shows a variation of the resecting device  105  with capacitance sensors  210 , it should be appreciated that other types of sensors can be used to determine the proximity of the cutting blade to an organ periphery, such as optical sensors, impedance sensors, magnetic sensors and the like. 
         [0041]    Now turning to  FIGS. 3A to 3D , a method corresponding to the invention is described relating to the resection of a uterus in a new form of laparoscopic hysterectomy.  FIG. 3A  is a schematic view of the patient&#39;s abdominal cavity and a uterus  240  targeted for resection. In a first step of the method, a first sleeve or cannula  242  is introduced through the abdominal wall  244  and an endoscope  245  is inserted through the sleeve to provide a field of view  246  in the abdominal cavity  248 . 
         [0042]      FIG. 3A  further shows a second cannula  252  introduced through the abdominal wall  244  after which a cutting-sealing device  255 , such as electrosurgical cutting and sealing device, is introduced through the cannula  252  for use in sealing and transecting blood vessels communicating with the uterus  240 . As is known in the art or performing a laparoscopic hysterectomy, the uterine arteries are sealed and transected, and the broad ligaments, fallopian tubes and fascia are transected along lines A and B to mobilize the uterus  240 . Thereafter, the cutting-sealing device  255  is withdrawn from cannula  252 . 
         [0043]      FIG. 3B  depicts a subsequent step of the method wherein a sharp trocar sleeve  260  is introduced through the second cannula  252  by the physician and then, under laparoscopic vision, the distal tip  262  of the trocar sleeve  260  is advanced through the uterine wall  244  into the uterine cavity  268 . 
         [0044]      FIG. 3C  shows the next step in the method wherein the resection device  105  is introduced through the cannula  252  and trocar sleeve  260  into the interior of the uterus  240 , and thereafter the trocar sleeve  260  is withdrawn leaving the working end  112  of the resection device  105  within the interior of uterus  240 . In one variation of the method, the fluid source  155  and infusion tubing  182  are coupled to the resection device  105  to provide a fluid flow into the uterine cavity  268  through the annular space between the outer sleeve  115  and the inner sleeve  125  (see  FIGS. 1-2 ). By this means, the uterine cavity  268  can be distended to some extent, while the controlled fluid inflow assists in the resecting procedure and further assists in the extraction of tissue debris from the site. In another variation (not shown), a cervical seal member can be introduced trans-vaginally to seal the uterine cavity  268 , wherein the cervical seal can be a probe shaft, an inflatable member or other types of seals know in the art. In another variation, the fluid source  155  and infusion tubing  182  can be coupled to a trans-cervical probe and seal (not shown) to provide a fluid flow into the uterine cavity  268 . 
         [0045]    Still referring to  FIG. 3C , the physician then can actuate the resecting device  105  to resect tissue in a blind method while observing the exterior of the uterus  240  with the endoscope  245 . The physician can manipulate the working end  112  of the resecting device  105  to core out the interior of the uterus  240  while leaving the uterine wall  244  completely intact as it cores tissue from within and apart from any access openings. It can now be seen that the purpose of the capacitance sensors  210  is provide signals to indicate the proximity of the cutting blade  126  to the exterior of the uterine wall  244 . As indicated in  FIG. 3D , in one variation, the capacitance sensors  210  can sense a change in tissue capacitance when the window  118  and blade move close to the exterior of the uterine wall  244 . The plurality of capacitive sensors  210  as shown in  FIG. 2  allows for sensing proximity to the surface of the uterine wall no matter the orientation of the working end  112 . The resecting procedure can be considered complete when the physician has removed a substantial volume of tissue from the interior of uterus  240  and in effect leaves only a shell  288  of the uterus in place as shown in  FIG. 3D . By this means, it can be understood that no resected tissue, and thus no potentially malignant tissue, has been exposed outside of the interior of uterus  240 . Rather, all tissue has been resected and immediately extracted through passageway  152  in the inner sleeve  125  and then collected in the collection chamber  178  with no possibility of contaminating the abdominal cavity  248 . In one aspect of the method, at least 50%, at least 60%, at least 70%, at least 80% or at least 90% of the mass of the uterus  240  is resected and extracted to leave a reduced-volume shell  288  of the uterus ( FIG. 3D ). Following the resection and extraction of the bulk of the uterus  240 , the reduced-volume shell  288  of the uterus can be removed in methods known as in a conventional supracervical or other laparoscopic hysterectomy procedure. Typically, the reduced-volume uterine shell  288  can be removed intact in a trans-vaginal approach. 
         [0046]    During the resection steps described above, the controller  140  can modulate fluid inflows to and from the site by controlling the roller pumps. The flow rates into and out of the uterine cavity  268  can be from 10 mL/min to 1000 mL/min, and also can be modulated depending on a cutting speed selected by the physician. 
         [0047]    In another embodiment in another variation shown in  FIG. 4 , a sensor enhancing media may be sprayed, painted flooded or otherwise disposed around the exterior of uterus  240  to enhance the sensitivity of the capacitance sensors  210  or other sensing mechanism. For example,  FIG. 4  illustrates a conductive gel  290  that may be sprayed or painted onto the exterior of the mobilized uterus  240  which will increase the resolution of the capacitive sensors  210 . Such a media  290  can be a conductive gel, such as a hypertonic saline gel. A similar conductive gel would enhance the resolution impedance sensors. In another variation, a magnetic sensitive material could be disposed around the uterus  240  which could increase the resolution of a magnetic sensor carried by the working end  112  of the resecting device  105 . In another variation shown in  FIG. 5 , a mesh net  300  can be disposed around the uterus  240  for similar purposes. For example, a structure similar to that stretchable nylon stocking with conductive threads could be disposed around the uterus  240  to increase the sensitivity of a capacitance sensor  210 , an impedance sensor or a magnetic sensor. 
         [0048]    In another variation, a source of illumination or light emitters may be disposed in one or more locations around the window  118  of the exterior sleeve  125 . Such illumination or light emitters can added to the device of  FIG. 2 , or can be used instead of capacitance sensors  210  or other sensors. The light emitters can be, for example, a distal end of one or more optical fibers, an LED source, or other source of visible illumination. It can be understood that the physician then can see the brightness of the light through the translucent uterine wall and understand the proximity of the cutting blade  126  to the wall surface. 
         [0049]    In one variation, the controller  140  includes algorithms to modulate or terminate operation of the resecting device  105  when the capacitance sensors  126  or other sensor mechanism indicate the proximity of the cutting blade to the exterior of uterine wall  244 . In another variation, the sensor system can provide warning signals to the position of the cutting blade in the form of aural, visual or tactile signals. 
         [0050]    By using the system and method described above, it can be understood that the laparoscopic hysterectomy can be performed without risk of dispersing any potentially malignant tissue in the abdominal cavity  268 . All resected tissue chips are maintained within the interior of the uterus  240  with the uterine wall itself functioning as a containment sac. The system and method can be performed with any type of resecting device, such as a mechanical cutter as shown herein, in which a blade can cut by rotation, reciprocation or both. In other variations, the resecting device may be an RF device, ultrasound device, laser device, microwave device, resistive heat device or the like.