SURGICAL SYSTEM AND METHOD OF USE

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

FIELD OF THE INVENTION

The present invention relates to systems and devices for resecting and removing tissue or organs from the interior of a patient's body, in a minimally invasive laparoscopic procedure while preventing any dispersion of potentially malignant tissue during the resection process.

BACKGROUND

The present invention relates to systems and devices for resecting and removing tissue or organs from the interior of a patient's body, in a minimally invasive laparoscopic procedure while preventing any dispersion of potentially malignant tissue during the resection process.

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'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.

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.

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.

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 from 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

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.

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.

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.

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.

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.

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.

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.

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.

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.

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.

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 the signal that the cutter is within a pre-determined proximity to the organ surface.

Variations of the method can also include mobilizing the organ with the intact organ surface after the substantial volume is removed and removing the organ from the patient's body.

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/

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.

In an additional variation, the present disclosure includes methods 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. The method can include sealing and/or ligating blood vessels communicating with the uterus.

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's body.

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.

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.

DETAILED DESCRIPTION OF THE INVENTION

FIGS. 1 and 2illustrate a tissue resection system100that includes a handheld single-use tissue cutting device or resection device105. The device105has a handle portion106that is coupled to a shaft portion110having an outer diameter ranging from about 3 mm to 20 mm. The shaft portion110extends along axis111and can have a length suitable for introducing directly into a body space or into an organ, for example, introducing through a trocar in a laparoscopic procedure or for introducing through a working channel of an endoscope.

In one variation, a handheld resecting device105as depicted inFIGS. 1 and 2can be used to perform a laparoscopic hysterectomy procedure as depicted inFIGS. 3A to 3D. Referring toFIGS. 1 and 2, the resection device105is a tubular cutter as is known in the art with a shaft portion110and working end112. The shaft110comprises an assembly of a first or outer sleeve115extending along axis111to a distal end116having a window118therein for receiving tissue. A second or inner sleeve125with a distal blade edge126and distal opening128is dimensioned to rotate in bore132of outer sleeve115. The outer and inner sleeves,115and125, are typically fabricated of thin-wall stainless steel but any other suitable materials can be used. As can be understood fromFIGS. 1-2, rotation of the inner sleeve125will cut tissue captured in the window118of the outer sleeve.FIG. 2shows the working end112of the assembly of outer sleeve115and inner sleeve125with the inner sleeve125rotating and in a partially window-open position.

As can be seen inFIG. 1-2, the resection system100includes a controller140that is adapted for (i) controlling a motor drive in the resecting device105as will be described below; (ii) controlling at least one sensor system carried by the resection device105that will be described further below, (iii) controlling a negative pressure source or outflow pump150operatively coupled to a tissue extraction channel152in the resection device105, and (iv) controlling an optional fluid source155and inflow pump160for distending or flooding a treatment site with a fluid, such as saline.

Referring toFIG. 1, the controller140includes algorithms for driving a motor162in the handle106of the resecting device105. The motor can be a brushless DC motor and controller140can be configured to operate the motor at a preset RPM or a user-selected RPM between 100 and 2,000 RPM.FIG. 1shows an electrical cable166extending from connector168in the controller140to the resecting device handle106. The resecting device105can be operated by a switch170in the handle106or a footswitch indicated that174coupled to the controller140.

Still referring toFIG. 1, the controller140includes a roller pump150that provides a negative pressure source for extracting tissue through the passageway152in the resecting device105. The roller pump150in combination with the flexible tubing176, is configured to pump fluid and extracted tissue chips through the tubing into the collection reservoir178.

Again, referring toFIG. 1, controller140has a second roller pump160adapted to provide fluid flows into a site targeted for resection. A fluid source155is coupled to a flexible fluid infusion tubing182that is engaged by the roller pump160and that further extends to a fitting on cannula190, which is adapted for access to the treatment site. The cannula190can be inserted into the site and can be used as an access pathway for the resection device105, or the cannula can be used for fluid infusion independent of the resection device. In another variation, the fluid infusion tubing182can be coupled to the resection device105so that fluid flows to the working end112and window118in a path in the annular space between the outer sleeve115and the inner sleeve125.

Now turning toFIG. 2, the working end112of the resecting device105is shown in an enlarged perspective view. In one variation shown inFIG. 2, a sensor system is shown disposed around the cutting window118in the working end. This variation shows four capacitance sensors210disposed around the window118, which comprise the distal termination of paired wire leads as is known in the art capacitance sensors. The capacitance sensors210are coupled to the controller140through cable214(FIG. 1). The sensors210can be carried in a thin polymeric coating220on the outer sleeve125. In this embodiment, there are four capacitance sensors, but there could be from 1 to 20 sensors on the outer sleeve125. 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 sensors210can provide a signal to the user when the cutting blade126(FIG. 2) approaches the periphery of an organ targeted for resection. WhileFIG. 2shows a variation of the resecting device105with capacitance sensors210, 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.

Now turning toFIGS. 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. 3Ais a schematic view of the patient's abdominal cavity and a uterus240targeted for resection. In a first step of the method, a first sleeve or cannula242is introduced through the abdominal wall244, and an endoscope245is inserted through the sleeve to provide a field of view246in the abdominal cavity248.

FIG. 3Afurther shows a second cannula252introduced through the abdominal wall244, after which a cutting-sealing device255, such as electrosurgical cutting and sealing device, is introduced through the cannula252for use in sealing and transecting blood vessels communicating with the uterus240. As is known in the art of 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 uterus240. Thereafter, the cutting-sealing device255is withdrawn from cannula252.

FIG. 3Bdepicts a subsequent step of the method wherein a sharp trocar sleeve260is introduced through the second cannula252by the physician, and then, under laparoscopic vision, the distal tip262of the trocar sleeve260is advanced through the uterine wall244into the uterine cavity268.

FIG. 3Cshows the next step in the method wherein the resection device105is introduced through the cannula252and trocar sleeve260into the interior of the uterus240, and thereafter the trocar sleeve260is withdrawn, leaving the working end112of the resection device105within the interior of uterus240. In one variation of the method, the fluid source155and infusion tubing182are coupled to the resection device105to provide a fluid flow into the uterine cavity268through the annular space between the outer sleeve115and the inner sleeve125(seeFIGS. 1-2). By this means, the uterine cavity268can be distended to some extent, while the controlled fluid inflow assists in the resecting procedure and further assists in the extraction of tissue chips from the site. In another variation (not shown), a cervical seal member can be introduced trans-vaginally to seal the uterine cavity268, wherein the cervical seal can be a probe shaft, an inflatable member, or other types of seals known in the art. In another variation, the fluid source155and infusion tubing182can be coupled to a trans-cervical probe and seal (not shown) to provide a fluid flow into the uterine cavity268.

Still referring toFIG. 3C, the physician then can actuate the resecting device105to resect tissue in a blind method while observing the exterior of the uterus240with the endoscope245. The physician can manipulate the working end112of the resecting device105to core out the interior of the uterus240while leaving the uterine wall244completely intact. It can now be seen that the purpose of the capacitance sensors210is to provide signals to indicate the proximity of the cutting blade126to the exterior of the uterine wall244. As indicated inFIG. 3D, in one variation, the capacitance sensors210can sense a change in tissue capacitance when the window118and blade move close to the exterior of the uterine wall244. The plurality of capacitive sensors210, as shown inFIG. 2allows for sensing proximity to the surface of the uterine wall no matter the orientation of the working end112. The resecting procedure can be considered complete when the physician has removed a substantial volume of tissue from the interior of the uterus240and, in effect, leaves only a shell288if the uterus is left in place, as shown inFIG. 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 the uterus240. Rather, all tissue has been resected and immediately extracted through passageway152in the inner sleeve125and then collected in the collection chamber178with no possibility of contaminating the abdominal cavity248. 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 uterus240is resected and extracted to leave a reduced-volume shell288of the uterus (FIG. 3D). Following the resection and extraction of the bulk of the uterus240, the reduced-volume shell288of the uterus can be removed in methods known as in a conventional supracervical or other laparoscopic hysterectomy procedure. Typically, the reduced-volume uterine shell288can be removed intact in a transvaginal approach.

During the resection steps described above, the controller140can modulate fluid inflows to and from the site by controlling the roller pumps. The flow rates into and out of the uterine cavity268can be from 10 mL/min to 1000 mL/min and can be modulated depending on a cutting speed selected by the physician.

In another embodiment in another variation shown inFIG. 4, a sensor enhancing media may be sprayed, painted, flooded, or otherwise disposed around the exterior of the uterus240to enhance the sensitivity of the capacitance sensors210or other sensing mechanisms. For example,FIG. 4illustrates a conductive gel290that may be sprayed or painted onto the exterior of the mobilized uterus240which will increase the resolution of the capacitive sensors210. Such a media290can 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 uterus240, which could increase the resolution of a magnetic sensor carried by the working end112of the resecting device105. In another variation shown inFIG. 5, a mesh net300can be disposed around the uterus240for similar purposes. For example, a structure similar to that stretchable nylon stocking with conductive threads could be disposed around the uterus240to increase the sensitivity of a capacitance sensor210, an impedance sensor, or a magnetic sensor.

In another variation, light emitters may be disposed in one or more locations around the window118of the exterior sleeve125. Such light emitters can be added to the device ofFIG. 2or can be used instead of capacitance sensors210or other sensors. The light emitters can be a distal end of one or more optical fibers, for example. It can be understood that the physician can then see the brightness of the light through the translucent uterine wall and understand the proximity of the cutting blade126to the wall surface.

In one variation, the controller140includes algorithms to modulate or terminate operation of the resecting device105when the capacitance sensors210or other sensor mechanisms indicate the proximity of the cutting blade to the exterior of uterine wall244. 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.

By using the system and method described above, it can be understood that the laparoscopic hysterectomy can be performed without the risk of dispersing any potentially malignant tissue in the abdominal cavity248. All resected tissue chips are maintained within the interior of the uterus240, 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.

Now turning toFIG. 6, another variation of the invention is shown, which again includes a handheld surgical resection device400with a handle404coupled to an elongated shaft410that extends about axis412to a distal end working end415that is configured with a tissue cutting mechanism or resecting component418.FIG. 7is an enlarged perspective view of working end415ofFIG. 6, which comprises an outer sleeve420with a tissue receiving window422and a rotating inner sleeve425with cutting window428therein that is rotated at high speed to resect tissue. A negative pressure source440is coupled to an interior lumen442in the inner sleeve425to suction tissue into the outer sleeve window422and inner sleeve window428to capture tissue for resection. A motor444in the handle404is operated by a controller445A and electrical source445B to rotate or oscillate the inner sleeve425at a high speed, for example, from 500 RPM to 15,000 RPM, as is known in the art. It should be appreciated that the tissue resecting component can comprise a mechanical resecting device, an electrosurgical resecting device, or an electrosurgical ablation device.

FIG. 7illustrates an ultrasound sensor450is carried on a surface of the shaft410located proximally from the proximal end452of window422in the outer sleeve420. In one variation, the sensor450can comprise a plurality of ultrasound transducers and is shown with two piezoelectric transducers455aand455bthat are oriented to propagate sound waves axially and angularly relative to axis412and outer and inner sleeve windows422and428. The ultrasound sensor typically uses a frequency ranging from 2 MHz to 10 MHz.

Now turning toFIGS. 8A and 8B, other similar variations of working ends415′ and415″ are shown, which function in a similar manner the working end415ofFIGS. 6 and 7.FIG. 8Aschematically illustrates the working end415′ with an ultrasound sensor assembly450′ comprising a series of piezoelectric transducers456positioned on each side of the outer sleeve window422. Any form of suitable housing (not shown) can be provided to house such transducers456. InFIG. 8B, the working end415″ illustrates an ultrasound sensor450″ comprising piezoelectric transducers458positioned both proximal and distal from the outer sleeve window422.

FIGS. 9A-9Dschematically illustrate a patient's uterus460and a method of using the resection device ofFIGS. 6 and 7in a form of supracervical hysterectomy procedure. InFIG. 9A, the shaft410of the resection device400is introduced through the patient's vagina462and endocervical canal464into a uterine cavity465. The shaft410includes an outer sleeve420with an articulating section468in which the inner sleeve is rotated by a flexible drive shaft as is known in the art.FIG. 9Ashows the angle of propagation470of ultrasound waves from the sensor450carried by the working end415. Now turning toFIG. 9B, it can be seen how the physician's movement of the shaft410axially, angularly, and rotationally415can be used to move cutting widows422,428across the fundus472of the uterine cavity465to resect and remove tissue. InFIGS. 9A and 9B, the dashed line indicates a calculated “resection limit”475where the ultrasound sensor450and controller440A determine that the exterior surface478of the uterus460is a selected distance from the working end415and wherein the controller delivers a warning or stops actuation of the resection device400.

FIG. 9Cillustrates another step of the method where the physician articulates the articulating section468and then again moves the shaft410and working end415axially, angularly, and rotationally415to orient the cutting widows422,428in a selected direction to resect tissue from a first lateral side484aof the uterine cavity465. At all times during such a resecting step, the ultrasound sensor450and controller440A are adapted to warn the physician or terminate actuation of the resection device when tissue cutting approaches the resection limit475.FIG. 9Dillustrates the articulated working end415being adjusted to resect tissue on the opposing or second lateral side484bof the uterine cavity465. Following the resection step illustrated inFIGS. 9A-9D, the bulk of the uterus will be resected, morcellated, and removed, leaving only the serosa488of the uterus intact. Thereafter, remaining serosa488can be resected and removed trans-vaginally or laparoscopically, and the tissue region around the endocervical canal464is sealed as is known in the art of performing a supracervical hysterectomy.

In another variation, the medical system includes a fluid source controlled by the controller for providing a controlled fluid inflow to the treatment site. In a variation, the controller is configured to maintain a selected set pressure in the treatment site. In another variation, the controller is configured to adjust the set pressure in response to an operating condition of the procedure, which can be at least one of (i) the volume of resected tissue, (ii) the number of times the controller de-activated the tissue resecting component, (iii) the change in sensed pressure in the site, (iv) the rate of change of sensed pressure in the site, and (v) total time of activation of the tissue resecting component.

In general, the medical system for resecting tissue in a body of a patient comprises a probe having an elongated shaft assembly extending about a longitudinal axis to a working end, where the working end is adapted for introduction into a site in an interior of an organ, a tissue resecting component within the working end, an ultrasound sensor carried by the working end, and a controller coupled to the tissue resecting component and the ultrasound sensor for sending imaging signals to the controller which locate the surface of the organ, and where the controller in response to the imaging signals, is configured to (i) determine a distance between the tissue resecting component and the surface of the organ; (ii) allow activation of the tissue resecting component when positioned at least a selected distance from said surface of the organ; and (iii) modulate activation of the tissue resecting component when positioned at less than said selected distance from said surface of the organ.

FIG. 10is a schematic view of another variation of the invention which depicts a robotic system490that includes a multi-joint robotic arm492that can move in multiple directions, where such a robotic system can carry the resection device400ofFIGS. 6 and 7, or at least a working end415as shown inFIGS. 7 and 11, to perform a surgical procedure, for example, a procedure of the type shown inFIGS. 9A-9D. InFIG. 11, the shaft410′ is shown with a robotically articulated joint495as well as a robotically-controlled articulating section68′ closer to the working end415. InFIGS. 10 and 11, it can be understood that a physician can move the multiple articulating elements of the robotic arm492to move the working end415axially, angularly, rotationally, as well as articulating the working end415, as shown inFIGS. 9C-9Dto robotically remove tissue in a hysterectomy procedure.

InFIG. 11, another optional component of the system490ofFIG. 10is shown, which comprises at least one additional ultrasound sensor500disposed outside the patient's body to image the targeted treatment site, which in this instance is the patient's uterus460. In the variation ofFIG. 10, two ultrasound sensors,500and502, are shown and are adapted to provide another layer of safety by detecting and displaying the outer surface of the uterus460and providing a second calculated “resection limit”505where the ultrasound sensors500,502and controller445A determine the location of the exterior surface478of the uterus460and define the resection limit as a selected distance inward from surface478. In this variation, the signals from ultrasound sensor450of the device400ofFIGS. 6-7and the first resection limit475can be integrated with, or compared to, the calculations provided by the external ultrasound sensors500,502for monitoring and managing the operation of the resection device relative to the exterior surface478of the uterus460.FIG. 12shows another variation of the invention where a second robotic system520with robotic arm522that is configured to carry the ultrasound sensor500ofFIG. 11. The controller445A can be programmed to move the robotic arm522and sensor500in coordination with the controlled movement of the first robotic arm492and resection device400. In addition, the second robotic arm522can carry a reservoir of ultrasound gel and a fluid delivery mechanism to apply the ultrasound gel to the patient's skin under and around the ultrasound sensor500.

FIGS. 13 and 14show another variation of a handheld treatment device550that in one variation has a working end552with jaws comprising a tissue sealing and cutting mechanism as is known in the art, for example, with an RF electrode arrangement555and a blade (not visible) that can be advanced in slot556in the jaws when closed (seeFIG. 14). The device550is coupled to RF source560A and controller560B. In this variation, an additional outer sleeve564is provided and carries a distal image sensor565. The outer sleeve564is adapted for positioning over the elongated the shaft568of the treatment tool550. In this variation, the image sensor565is coupled to controller560B, which includes an imaging processor that is adapted for displaying video images on a display (not shown). The outer sleeve564is moveable axially and rotationally to allow the physician to observe the treatment site as the working end552of the treatment tool550is moved.

FIG. 14is an enlarged view of the working end552of the device550ofFIG. 13, where it can be seen that the distal section572of the movable outer sleeve564carries the image sensor565, as well as an, LED575for illuminating the targeted site. In addition, the distal section572of the sleeve564carries an accelerometer576for sending the controller560B signals of the rotational and angular position of the working end552, which then is used to create a stable, “upright” image on the video display. In other words, the accelerometer576can rotate and maintain the images in an upright orientation on a display no matter the rotational movement of the outer sleeve564and image sensor565.

It should be appreciated that the treatment device550ofFIG. 13can consist of a grasper, a tissue sealer, a tissue cutter, a biopsy device, a morcellation device, an ablation device, and a stapler. In another variation, the treatment device550can further include a robotic mechanism as described above coupled to the outer sleeve564configured to move the sleeve rotationally relative to the shaft. In another variation, a robotic mechanism is coupled to the tissue treatment device550and the moveable outer sleeve564, where the robotic mechanism is configured to move the treatment device in at least one direction selected from rotationally, axially, angularly, or a combination thereof, and where the robotic mechanism is further configured to move the sleeve564rotationally relative to the shaft.