STAPLER APPARATUS AND METHODS FOR USE

Apparatus and methods are provided for performing a medical procedure, such as a laparoscopic appendectomy using a stapler apparatus including a reusable handle portion including a shaft include proximal and distal ends, a disposable end effector attached to the distal end of the shaft of the reusable handle carrying one or more staples. For example, the end effector may include first and second jaws movable relative to one another between open and closed positions, the first jaw carrying a cartridge which includes the one or more staples. A Doppler sensor, a cutting element, and, optionally, a thermal element are also provided on the end effector. The end effector is introduced into a patient's body, tissue is positioned/locked between the jaws, and a plurality of staples are deployed into the tissue. The Doppler sensor is used to confirm that blood flow has discontinued in the stapled tissue, and the cutting element is actuated to sever the stapled tissue.

FIELD OF THE INVENTION

The present invention relates generally to apparatus, systems, and methods for performing medical procedures, and, more particularly, to stapler apparatus for performing laparoscopic or other surgery, e.g., to remove an appendix of a subject, and systems and methods for using such apparatus.

BACKGROUND

Appendicitis is seen in approximately 5-10% of the population in their life time. Since 1983, laparoscopic appendix surgery is the mainstay for treatment. In an example of conventional surgery to remove an appendix, the following steps may be performed. First, the appendix and its vessel may be initially identified e.g., lying within a fold of tissue called the mesoappendix. A window or surgical field may be created within the subject's body, and a stapler apparatus is then used, e.g., to initially staple and divide the structure closest to the operator, and then to staple and divide the remaining structure.

For example,FIG. 1shows exemplary anatomy of an appendix, which may have one of a variety of orientations relative to the intestine, most commonly retrocecal (64%) or pelvic (32%), although less common positions may also be encountered, as shown. An appendicular artery and other blood vessels (not shown) deliver blood to the appendix, whose location relative to the intestine may also vary depending on the orientation of the appendix. The appendix and artery may be separated by fat and/or other tissue. Thus, during a procedure, upon accessing the abdominal cavity, the operator must identify the relative locations of the appendix and vessels before removing the appendix. For example, after identification, the operator may identify the intra-operative manifestation or positioning of the appendix and its vessel, i.e., to identify whether the appendix is closer to the operator and the vessel is positioned further away or vice-versa, and then sequentially staple and divide the closer structure, and then the more distant structure.

To perform laparoscopic or open surgery, a device may be introduced carrying a camera that is independent from the stapler, e.g., to enable visualization of the surgical space and anatomy from the side, e.g., when the stapler is introduced and used to remove the appendix. Existing laparoscopic staplers generally include a cartridge having multiple rows of staples equally distributed on either side of a knife.

One of the most common complications from such surgery is post-operative bleeding. The bleeding is generally sub-clinical in approximately 15%, and clinical in approximately 5% patients, i.e., requiring further intervention. The majority of bleeding occurs from the staple line on individual vessels or vessels within the wall of intestine. For example, “B” shaped clips may create a lumen between the tines that may allow blood or other fluid to escape. Other complication include leaking of intestinal fluid from the intestinal lumen.

Accordingly, apparatus and methods that facilitate laparoscopic surgery, e.g., to remove an appendix would be useful.

SUMMARY

The present invention is directed to apparatus, systems, and methods for performing medical procedures, and, more particularly, to stapler apparatus for performing surgery, such as laparoscopic surgery, e.g., to remove an appendix of a subject or to perform other intestinal procedures, vascular surgery, lung surgery, and the like, and to systems and methods for using such apparatus.

In accordance with an exemplary embodiment, an apparatus is provided for performing a medical procedure that includes a shaft including a proximal end and a distal end sized for introduction into a patient's body; first and second jaws on the distal end of the shaft that are movable relative to one another between open and closed positions, thereby directing first and contact surfaces of the first and second jaws away from and towards one another, respectively, the first jaw carrying one or more staples deployable from the first contact surface; a Doppler radar or other sensor on one of the first and second contact surfaces; and a handle on the proximal end of the shaft comprising a first actuator for opening and closing the jaws, e.g., a trigger to close the second jaw adjacent the first jaw to capture tissue between the contact surfaces, a second actuator for deploying one or more staples from the first jaw into tissue between the first and second contact surfaces, e.g., after locking the jaws closed using the trigger or a separate locking mechanism, and a third actuator for activating the Doppler or other sensor to detect blood flow in the tissue.

In an exemplary embodiment, the first and second jaws may be carried on an end effector removably coupled to the distal end of the shaft. The first jaw may carry first and second sets of staples, e.g., each set arranged in rows adjacent one another, optionally arranged within a replaceable cartridge. A cutting element may be disposed on the distal end, e.g., movable between the first and second sets of staples, e.g., using a fourth actuator on the handle to advance the cutting element to sever the stapled tissue. In addition or alternatively, a thermal element or other hemostasis element may also be provided on one of the first and second jaws, e.g., opposite the Doppler sensor, and the handle may include a fifth actuator for activating the hemostasis element to deliver thermal energy to the stapled tissue. Optionally, the handle may include one or more additional actuators, e.g., one or more controls for positioning and/or activating a light and/or camera carried on the distal end of the shaft or the end effector.

In accordance with another embodiment, an end effector is provided for a stapler apparatus including a shaft including a proximal end including a handle and a distal end sized for introduction into a patient's body. The end effector may include one or more connectors for removably connecting the end effector to the distal end of the shaft and, optionally, a cartridge insertable into a recess of one of the jaws. The first and second jaws are movable relative to one another between open and closed positions, thereby directing contact surfaces of the first and second jaws away from and towards one another, respectively. For example, the first jaw may be fixed and the second jaw may be pivotally mounted to open and close relative to the first jaw, e.g., to capture tissue between the contact surfaces. One or more staples are carried by the first jaw, e.g., in a replaceable cartridge, such that actuation of a staple actuator on the handle deploys one or more staples from the first jaw into tissue between the contact surfaces and towards the second jaw to deform the one or more staples. Optionally, a Doppler radar sensor and/or hemostasis element may be provided on one of the contact surfaces to detect blood flow in the tissue.

In accordance with still another embodiment, a method is provided for performing a surgical procedure within a patient's body that includes introducing first and second jaws on a distal end of a shaft into a region within the patient's body; with the jaws in an open position, placing tissue within the region between contact surfaces of the first and second jaws; closing the jaws to engage the tissue; actuating a staple actuator to deploy one or more staples from the first jaw into the tissue towards the second jaw to deform the one or more staples and secure the tissue. For example, the second jaw may be closed to squeeze the tissue between the contact surfaces and, optionally, may be locked in the closed position. The staple(s) may be then be deployed from the first jaw using the staple actuator such that they are directed through the tissue and engage anvils or shaping surfaces on the second jaw to deform tines of the staple(s). A Doppler or other sensor on one of the contact surfaces may be activated to detect blood flow in the stapled tissue; and after confirming that blood flow has discontinued in the stapled tissue, a cutting element may be actuated to sever the stapled tissue from adjacent tissue at the region.

In accordance with yet another embodiment, a method is provided for performing an appendectomy within a patient's body that includes introducing first and second jaws on a distal end of a shaft into an abdominal cavity of the patient's body; placing an appendix and appendicular artery within the abdominal cavity between contact surfaces of the first and second jaws; actuating one or both of the first and second jaws to secure the appendix and artery between the contact surfaces; and deploying one or more staples from the first jaw through the appendix and artery to staple the appendix and artery. Thereafter, a Doppler sensor on one of the contact surfaces may be activated to detect blood flow in the stapled appendix and artery, and, if blood flow is detected, a thermal element may be activated to deliver thermal energy to stop blood flow, e.g., alternately to detect and cauterize the tissue. Once blood flow ash stooped, a cutting element may be actuated to simultaneously sever the appendix and artery.

In accordance with another embodiment, an apparatus is provided for performing a medical procedure that includes a shaft including a proximal end, a distal end sized for introduction into a patient's body, and a longitudinal axis extending between the proximal and distal ends; first and second jaws on the distal end of the shaft that are movable relative to one another between open and closed positions, thereby directing first and contact surfaces of the first and second jaws away from and towards one another, respectively, the first jaw carrying first and second sets of staples positioned on opposite sides of a cutting element, wherein at least some of the staples are a different size than other staples; and a handle on the proximal end of the shaft. For example, each set of staples may include one to five rows of staples aligned along the longitudinal axis, with two to fifty staples in each row. The staples in each set and/or each row may have different sizes depending on the anatomy encountered. For example, the apparatus may include a plurality of available cartridges, each including different arrangements of staples, that may be selected and inserted into a cavity of the first jaw. The handle includes a first actuator for driving the staples from the first jaw into tissue between the first and second contact surfaces and towards the second jaw to deform the staples; and a second actuator for advancing the cutting element from a retracted position to an advanced position aligned with the longitudinal axis to sever the stapled tissue.

In accordance with yet another embodiment, an end effector is provided for a stapler apparatus including a shaft comprising a proximal end including a handle, a distal end sized for introduction into a patient's body, and a longitudinal axis extending between the proximal and distal ends. The end effector may include one or more connectors for removably connecting the end effector to the distal end of the shaft; first and second jaws that are movable relative to one another between open and closed positions using a first actuator on the handle, thereby directing first and contact surfaces of the first and second jaws away from and towards one another, respectively; and a cartridge carried by the first jaw comprising first and second sets of staples arranged in rows on opposite sides of a cutting element such that actuation of a second actuator on the handle deploys the staples into tissue between the first and second contact surfaces and drives the staples against the second jaw to deform the one or more staples, wherein at least some of the staples are a different size than other staples.

In accordance with still another embodiment, a staple is provided for delivery into tissue that includes a substantially straight base element including first and second ends; a first tine extending from the first end substantially perpendicular to the base, the first tine having a first length and including one or more notches adjacent a tip of the first tine; and a second tine extending from the second end substantially perpendicular to the base to a second tip, the second tine having a second length longer than the first length and longer than the length of the straight base such that, when the second tine is bent adjacent the base, the second tip of the second tine is engaged in the one or more notches located on the first tine.

In accordance with another embodiment, a port is provided for introducing one or more instruments into a patient's body that includes an elongate tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, and a lumen extending between the proximal and distal ends, thereby defining a longitudinal axis there between; a display; and one or more deployment arms on the tubular member adjacent the distal end carrying an imaging device, each deployment arm comprising a first end pivotably coupled to the tubular member and a second free end that is movable from a retracted position wherein the second end is aligned with a wall of the tubular member and a deployed position wherein the second end moves outwardly relative to the longitudinal axis for presenting images on the display.

In accordance with still another embodiment, a port is provided for introducing one or more instruments into a patient's body that includes an elongate tubular member comprising a proximal end, a distal end sized for introduction into a patient's body, and a primary lumen extending between the proximal and distal ends for receiving an instrument therethrough, and a plurality of secondary lumens positioned around the primary lumen and extending between the proximal and distal ends; and a video module. The video module may include a hub; a display; and a plurality of elongate imaging elements mounted to the hub and sized for introduction simultaneously into respective secondary lumens of the tubular member such that distal tips of the imaging elements are positioned adjacent the distal end of the tubular member for acquiring images beyond the distal end.

DETAILED DESCRIPTION OF THE EXEMPLARY EMBODIMENTS

Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. Although any methods and materials similar or equivalent to those described herein can be used in the practice or testing of the present invention, some potential and exemplary methods and materials are now described.

It must be noted that as used herein and in the appended claims, the singular forms “a,” “an,” and “the” include plural referents unless the context clearly dictates otherwise. Thus, for example, reference to “a compound” includes a plurality of such compounds and reference to “the polymer” includes reference to one or more polymers and equivalents thereof known to those skilled in the art, and so forth.

Turning to the drawings,FIG. 2Ashows an exemplary embodiment of a stapler apparatus8that may be used during a medical procedure, e.g., during laparoscopic surgery to remove a patient's appendix (not shown). Generally, the apparatus8includes a reusable shaft/handle portion or handpiece10including a shaft20and a handle30, and a disposable, single-use portion or end effector40, e.g., configured to receive a single-use cartridge (not shown), which may be removably coupled to the shaft20before or during a procedure, as described further below. Alternatively, at least some of the components of the end effector40may be permanently incorporated into the reusable portion10, e.g., such that the entire apparatus8may be single-use or may be cleaned between procedures and reused.

As shown, the shaft20is an elongate member, e.g., a substantially rigid tubular body, including a proximal end22and a distal end24, defining a longitudinal axis26extending there between. The shaft20may include one or more lumens or passages (not shown) extending between the proximal and distal ends22,24, e.g., for receiving actuator elements, wires, and/or other components, as described elsewhere herein. At least the distal end24of the shaft20is sized for introduction into a patient's body, e.g., having a diameter sufficiently small enough to be received through a port or cannula to allow introduction into a laparoscopic surgical space within a patient's body.

Optionally, at least a portion of the shaft20may be malleable, e.g., such that at least a distal region of the shaft20may be deformed into a desired shape outside the patient's body, which the shaft20may maintain during introduction. Alternatively, at least a distal region of the shaft20and/or the end effector40may be flexible, e.g., for introduction into body passages, such as blood vessels, GI passages, and the like, such that the distal region follows the passages during introduction. Optionally, in this alternative, the shaft20may include one or more steering wires or other elements therein (not shown) that may be actuated to change the shape of the shaft20, e.g., to facilitate introduction into a desired location and/or manipulation within the patient's body.

The handle30may include a handgrip32, e.g., shaped and/or otherwise configured to facilitate holding and/or manipulating the apparatus8during use. In addition, the handle30may include one or more actuators, e.g., for operating mechanical and/or electrical components on the stapler assembly40. For example, a trigger or other jaw actuator34may be provided, e.g., adjacent the handgrip32, that may be pulled or otherwise actuated to jaws46,47and a separate actuator (not shown) may be provided to subsequently deploy one or more staples (not shown) from the stapler assembly40. For example, the trigger34may be pulled to close the second jaw48immediately adjacent the first jaw46to engage tissue between contact surfaces46a,48a, e.g., as described further elsewhere herein. Optionally, the trigger34may include a ratchet mechanism to allow the second jaw48to move towards the first jaw46while preventing opening, e.g., to squeeze tissue between the jaws46,48, e.g., until a release mechanism is actuated. Alternatively, a separate locking mechanism may be provided on the handle30, which may be selectively activated to lock and release the second jaw48, as described elsewhere herein, In addition or alternatively, several other actuators may be included on the handle30or shaft2010to achieve independent actuation of various functions/parts of the end effector, such as a staple actuator that be advanced to deploy one or more staples and/or retracted, a cutting actuator for blade actuation (forward and backward), a Doppler sensor trigger, an electrical cautery power switch, and/or an actuator for controlling end effector orientation.

Optionally, as shown inFIGS. 2B and 2C, a display or other output device38may be provided on the handle30, e.g., to facilitate observing or otherwise monitoring the procedure. For example, a camera, light, and/or other imaging device (not shown) may be provided on the stapler assembly40and/or the distal end24of the shaft20that may be used to acquire images of a surgical space into which the stapler assembly40is introduced, as described further elsewhere herein. In one embodiment, a display38may be removably mounted on the handle30, which may include one or more connectors or cables (not shown) that may be coupled to corresponding connectors on the handle30, which are, in turn, coupled to one or more wires extending to the imaging device on the stapler assembly40. Alternatively, the display38may be permanently mounted to the handle30and one or more wires or other elements may communicate with the imaging device. In another alternative, a display (not shown) may be provided that is separate from the apparatus8, and the apparatus8may include a communications interface, e.g., a wireless transmitter, that may transmit signals from the imaging device wirelessly, e.g., using Bluetooth or other communications protocols, to allow images to be presented on the display.

For example, a CMOS, CCD, or other imaging element (not shown) may be provided on the distal end24of the shaft20(or alternatively on the end effector40) that is oriented to acquire images of the region beyond the stapler assembly40and/or between jaws46,48of the end effector40. One or more wires and/or optical fiber may transmit signals to the display38, which may include a processor to process the signals and present the images on a screen of the display38. In addition or alternatively, one or more LEDs or other light sources may be provided on the distal end24of the shaft20(or alternatively on the end effector40), e.g., adjacent the imaging element to provide illumination for the images. For example, one or more lights may be arranged circumferentially on the distal end24of the shaft20, such as a circular Xenon LED lamp (not shown), e.g., operating at 200-2500 W, that may provide dispersed illumination (due to internal reflections in the lamp) without generating thermal energy that may damage nearby tissue. Alternatively, one or more LEDs or other light sources (not shown) may be provided in the handle30, and light may be transmitted using light conductive material such as optical fiber or transparent plastic to provide illumination to the distal end24. The handle30and/or display38may include one or more controls (not shown), e.g., to turn the illumination source(s) and/or imaging element(s) off and on, as desired. Optionally, the imaging element(s) and/or illumination source(s) may be movable relative to the end effector40, e.g., rotated about the longitudinal axis26and, if so, one or more actuators (not shown) may be provided on the handle30to rotate or otherwise adjust their position during a procedure.

Returning toFIG. 2A, generally, the end effector40on the distal end24of the shaft20includes first and second jaws46,48carrying one or more staples (not shown) and, optionally, one or more additional components for use during a procedure. For example, as shown inFIGS. 3A-3C, the end effector40may include a removable cartridge50receivable within a recess, track, or other cavity46cwithin the first jaw46. The end effector40may also include a tubular housing42from which the first jaw46extends that includes a proximal end44that may be connected to the distal end24of the shaft20, e.g., using one or more detents, latches, sockets, threads and/or other connectors (not shown) on the proximal end44of the housing40and/or the distal end24of the shaft20. When the end effector40is mechanically connected to the shaft20by the connector(s), additional connectors may automatically engage, e.g., to mechanically couple actuatable components on the end effector40with actuator elements in the shaft20and/or electrically couple electrical components on the end effector40with corresponding wires in the shaft20(not shown), as will be appreciated by those skilled in the art. For example, a wedge mechanism (not shown, see, e.g.,FIGS. 15A-15D) may be provided within the housing42adjacent the first jaw46that may be coupled to an actuator shaft (also not shown) within the shaft20such that actuation of a staple actuator on the handle30may be activated to advance and retract the actuator shaft and wedge to deliver the staples, as described elsewhere herein.

As shown, the first jaw46may be integrally formed with or otherwise fixed relative to the housing42, e.g., such that the first jaw46remains aligned with the axis26of the shaft20during use. The second jaw48may be movably mounted to the housing42, e.g., by one or more hinges or other features (not shown) such that the second jaw48may be pivotable between an open position, e.g., as shown inFIG. 3A, and a closed position, e.g., as shown inFIG. 3B. In the open position, contact surfaces46a,48aof the jaws46,48may be spaced apart from one another, e.g., to allow a tissue structure to be positioned between the jaws46,48, e.g., on the first contact surface46a, while in the closed position, the contact surfaces461,48bmay be immediately adjacent one another, e.g., substantially parallel to one another, as shown inFIG. 3B. For example, in the closed position, the contact surfaces46a,48amay have sufficient clearance between them to squeeze, secure, and/or otherwise engage tissue positioned between the jaws46,48.

The jaws46,48may be biased to one of the open and closed positions or may be actuatable between the open and closed positions. For example, the jaws46,48may be provided initially in a closed position, e.g., to facilitate introduction into a patient's body, whereupon a lock or other mechanism may be released, whereupon the second jaw48may automatically move to the open position, and the actuator34on the handle30may become active to deploy staples and/or close the second jaw48, as described further elsewhere herein. Alternatively, the trigger34on the handle30may be pulled or released to close and open the second jaw48without deploying staples to facilitate introduction and/or manipulation of the cartridge40, e.g., until a switch or other control is actuated to activate deployment of the staples. A locking mechanism, e.g., a ratchet or other lock (not shown), may be provided to prevent the second jaw48from opening until released.

With particular reference toFIG. 3A, the first jaw46may receive a disposable cartridge50which may be received in cavity46cof the first the jaw46such that an exposed surface50aof the cartridge50defines the first contact surface46a. The cartridge50may carry a plurality of staples (not shown), e.g., in arranged in a plurality of rows aligned with the axis26of the shaft20. For example, in the embodiment shown, the contact surface50aof the cartridge50includes recesses or receptacles52arranged in three rows52a,52b,52cfrom which staples may be deployed simultaneously and/or in rapid succession.

Optionally, the cartridge50or first jaw46may include a thermal element56on the first surface46aadjacent the rows of staples. For example, the cartridge50may include sets of staples disposed on opposite sides of the thermal element56, e.g., with the sets aligned with the axis26of the shaft20. Alternatively, as shown inFIGS. 5A-5C, the thermal element may be omitted from the jaws/cartridge, if desired. If the staples are carried by a cartridge50that is removable from the first jaw46, the thermal element56may be mounted on an exposed surface of the cartridge50, e.g., if the cartridge50provide the first contact surface46a. Alternatively, the thermal element56may be permanently mounted on the first jaw46and the cartridge50may define the portions of the first contact surface46aon either side of the thermal element56(not shown).

In the example shown inFIGS. 3A and 4A, a first row or set of staple receptacles52amay be located on the right side of the thermal element56(from the perspective of a user holding the handle30of the apparatus8), and second and third rows or sets of staple receptacles52b,52cmay be located on the left side of the thermal element56. For example, in this configuration, the first set of staples may be delivered into the appendix being removed, while the second set of staples may be delivered into the intestine and remain within the patient's body after the appendix is removed. Alternatively, the arrangement of the receptacles52may be reversed if desired, e.g., with the first set on the left and the second set on the right for approaches where the appendix is on the left (from the perspective of the operator of the apparatus8) and the intact intestine is on the right. As shown, the second set of receptacles52b,52cmay include two rows of staples that are staggered relative to one another along the axis26, e.g., to enhance stapling a tissue structure captured in the jaws46,48, as described elsewhere herein.

In the embodiment shown inFIGS. 3A and 4A, the receptacles52have similar dimensions, e.g., having the same length aligned with the axis26, and the staples deployable from the receptacles52may have the same dimensions. Alternatively, the dimensions of the receptacles and, consequently, the staples, may be varied along each row and/or in different rows, as described further elsewhere herein.

For example,FIG. 4Bshows an alternative embodiment of a first jaw146(generally similar to jaw46) except that the rows of staple receptacles152include a first or proximal set of receptacles153aand a second or distal set of receptacles153bthat have different sizes. For example, as shown, the first two receptacles in each row152(in the proximal set153a) are larger than the remaining five receptacles (in the distal set153b). In this alternative, when the staples are deployed, the larger, proximal staples will be deployed first followed by the smaller, distal staples, e.g., as the staple actuator (e.g., a piston and/or sledge, not shown) advances and the pushes the staples against the second jaw48(also not shown) to deform the deployed staples.

Alternatively, as shown inFIG. 4C, different size staples may be provided in one or more of the rows on the first jaw246. For example, as shown, the first row may include receptacles252athat are larger than the second and third rows of receptacles252b,252c. Consequently, larger staples may be deployed from the first row of receptacles252athan the others. For example, it may be desirable to use larger staples to staple an appendix while smaller staples may be used to staple the blood vessel delivering blood to the appendix. Many smaller staples may enhance cutting off blood flow to the vessel, which may reduce risk of subsequent bleeding when the appendix is severed and removed. Thus, cartridges may be provided with multiple rows on either the left or right side of the cutting element60and with larger staples on the other side such that an appropriate cartridge may be selected and connected to the handpiece30based on the actual anatomy encountered. Optionally, one or more additional rows or sets of staples may be provided adjacent the first, second, and/or third rows. For example, multiple sets of staples (e.g., 1-5) may be delivered into the appendix being removed and/or into the intestine.

Returning toFIG. 3A, the contact surface48aof the second jaw48may include corresponding recesses54, e.g., arranged in rows opposite the receptacles52, e.g., such that the recesses54are disposed directly above respective receptacles52in the closed position, e.g., to deform and/or otherwise close staples deployed from the receptacles52, as described further elsewhere herein. For example, the recesses54may include ramped surfaces, anvils, and/or other features to deform one or both of the tines of the staples as they are deployed, as described further elsewhere herein.

Optionally, the second jaw48may include a Doppler radar or other sensor58, e.g., located on the second contact surface48agenerally opposite the thermal element56. For example, the Doppler sensor58may be an elongate crystal element mounted on the second contact surface56and aligned along the axis26(when the second jaw48is closed). The Doppler sensor58may be configured to transmit radar signals and receive reflections from the tissue captured between the jaws46,48to identify whether blood is flowing within the tissue, e.g., using systems and methods known in the art.

As can be seen inFIG. 3C, the thermal element56and Doppler sensor58may be located opposite one another on the first and second jaws46,48, respectively, between the rows of staple receptacles52and recesses54. This configuration may facilitate identifying blood flow within tissue captured between the jaws46,48and then delivering thermal energy to cauterize, ablate, or necrose the tissue, e.g., to stop subsequent blood flow, as described elsewhere herein.

In an exemplary embodiment, the thermal element may include one or more electrodes, e.g., a single elongate electrode56, e.g., extending axially along the first contact surface46a, which may be coupled to a source of electrical energy, e.g., a generator (not shown), in the handle30and/or connected to the handle30, as described further elsewhere herein. For example, as shown inFIG. 3C, the electrode56may include a thermal insulator block56a, e.g., formed from ceramic and/or other material that is not electrically conductive, and an electrode element56bsupported by the block56a, e.g., to prevent conduction from the electrode56to other components of the end effector40and/or delivering energy to tissue that is not directly contacted by the electrode element56b. In the embodiment shown, a single electrode56may be provided for delivering radiofrequency energy in a mono-polar configuration to cauterize the contacted tissue, e.g., similar to Bovie® devices, as described elsewhere herein. Alternatively, multiple electrodes may be provided that are spaced apart from one another on the first contact surface46a, which may be used to deliver RF energy in a bi-polar configuration. In a further alternative, other elements may be provided for delivering other forms of energy, e.g., laser, energy to cauterize contacted tissue.

Alternatively, the location of the thermal element56and Doppler sensor58may be reversed, if desired, e.g., with the thermal element on the second contact surface and the Doppler sensor on the first contact surface (not shown). In a further alternative, the thermal sensor may be omitted entirely and only a Doppler sensor58may be provided on one of the jaws, e.g., on the second jaw48, as shown inFIG. 5A. Thus, in this alternative, the first jaw46′ does not include a thermal element.

In yet another alternative, the Doppler sensor may be provided at other locations on the second contact surface on any of these embodiments. For example, as shown inFIG. 5B, a Doppler sensor58may be provided along one side of the second jaw48, i.e., adjacent the third row of recesses54copposite the third row of staple receptacles52c.

In the embodiments shown inFIGS. 3C, 5A, and 5B, the Doppler sensor is oriented substantially perpendicular to the second contact surface. In this configuration, the centerline of the radar signals transmitted will also be perpendicular to the second contact surface. Alternatively, it may be desirable to orient the Doppler sensor at a non-perpendicular angle relative to the contact surface. For example, as shown inFIG. 5C, another example is shown in which a Doppler sensor58′″ is mounted on the second jaw48′″ such that the sensor defines an angle relative to the second contact surface58a′″. Thus, in this alternative, the centerline of transmitted radar signals may directed diagonally from the second contact surface58a′″. Such a configuration may be useful, e.g., to direct the radar signals towards a tissue structure of particular interest, e.g., towards the blood vessel of the appendix, e.g., defining an angle relative to the direction of blood flow rather than perpendicular to the direction of blood flow.

Returning toFIGS. 3A-3C, the end effector40may also include a blade or other cutting element60slidably disposed relative to the jaws46,48. For example, the first and second jaws46,48may include respective slots or grooves62,64aligned with the axis26that receive the blade60, e.g., when the blade is advanced from a retracted position (not shown), e.g., received within the housing42immediately adjacent the contact surfaces46a,48a, to an advanced position, i.e., where a sharpened edge60aof the blade60is advanced distally along the slots62,64towards distal tips46b,48bof the jaws46,48(the blade60is shown partially advanced inFIG. 3A). As can be seen inFIG. 3B, the blade60may extend between the contact surfaces46a,48aof the jaws46,48, such that the edge60acuts through or otherwise severs tissue (not shown) positioned between the jaws46,48in the closed position, as described further elsewhere herein.

Optionally, the cartridge40may include one or more additional components for use during a procedure. For example, an illumination source and/or imaging element may be mounted on the housing42, e.g., to facilitate imaging and/or monitoring use of the apparatus8during a procedure. In an exemplary embodiment, a CMOS, CCD, or other imaging element and/or one or more LEDs or other light sources (not shown) may be provided on the end effector40, e.g., adjacent the proximal end of the first jaw46where the second jaw48pivots, that may be oriented distally to acquire images of the region beyond the stapler assembly40. For example, the field of view of the imaging element may include the first contact surface46aof the first jaw46such that an operator may use the images to position and/or orient a desired tissue structure on the contact surface46abefore actuating the second jaw48to close.

The apparatus8may be used to deliver staples into tissue during a medical procedure, e.g., during a laparoscopic surgical procedure, such as an appendectomy. Initially, a surgical space may be created, e.g., by introducing a trocar and/or cannula device (not shown) through the patient's skin and intervening tissue to a target region, e.g., the patient's abdominal cavity, and insufflating or otherwise opening the space to access a desired tissue structure, such as an appendix indicated for removal.

An end effector40and cartridge50may be selected and connected to the distal end24of the shaft20before introduction into the patient's body. For example, based on the anatomy encountered, the operator may select a cartridge50including a particular arrangement of staples, e.g., including uniform-size staples or different size staples, such as those described elsewhere herein, insert the cartridge50into the cavity46cof the first jaw46, e.g., before or after connecting the end effector40the shaft20. Once the apparatus8is ready, the distal end24of the shaft20carrying the end effector40may be introduced into the surgical space, e.g., through a cannula or other port (not shown), until the jaws46,48are located the surgical space. For example, the surgical space may be initially accessed using a needle, trocar, and/or dilator device, e.g., punctured through the patient's skin and intervening tissue into the abdominal cavity to approach the appendix, and a cannula may be positioned through the puncture. Gas may be delivered through the cannula or other device to insufflate and create a surgical cavity or space.

The distal end24of the shaft40, carrying the selected end effector40and/or cartridge50, may then be introduced through the cannula into the surgical space. For example, the jaws46,48may be initially locked in the closed position to facilitate introduction through the cannula and then may be released once located within the surgical space, whereupon the second jaw48may open. Alternatively, the second jaw48may be biased to open but may be manually or otherwise closed to allow insertion through the cannula.

With the jaws46,48in the open position within the surgical space, tissue within the region, e.g., the patient's appendix, may be placed on the contact surface46aof the first jaw46and/or otherwise positioned between the jaws46,48. For example, both the appendix and the appendicular artery may be positioned between the jaws46,48, e.g., with one distal to the other depending on the orientation of the appendix.

Once the tissue is positioned as desired, the trigger actuator34may be manipulated to close the second jaw48and lock the tissue in place between the contact surfaces46a,48a. For example, the trigger34may include a ratchet mechanism that allows the second jaw48to close while preventing it from reopening, or a separate locking mechanism (not shown) may activated once the second jaw48is closed to engage the tissue. A separate staple actuator (not shown) may then be used to deploy one or more staples from the first jaw46into and through the tissue and towards the second jaw48to deform the staples(s) and engage the tissue.

For example, as the stapler actuator is pushed, an actuation shaft (not shown) within the shaft20may advance a wedge or other staple actuation element (not shown) within the cartridge50or end effector40to begin deploying staples from the receptacles52out of the first contact surface50a/46aof the first jaw46upwardly towards the second jaw48, thereby causing one or more tines of the staples to contact the corresponding recesses54in the second contact surface48aand deform to staple the tissue.FIGS. 15A-15Dshow an exemplary embodiment of a wedge actuator66slidable within a passage53within a cartridge50that includes an angled or ramped distal surface66athat may push corresponding ramped surfaces68aof pistons (one piston68shown) within respective receptacles52upwardly to push the corresponding staples90towards the second jaw48(not shown inFIGS. 15A-15D), where tines of the staples90are deformed within the corresponding recesses54, as described elsewhere herein. For example, the wedge66may be coupled to a stapler actuator shaft (not shown) that may be advanced and retracted within the passage53, e.g., to advance the wedge66, thereby slidably engaging the ramped surface66aof the wedge66with ramped surfaces68aof the pistons68and directing the pistons68upwardly in the respective receptacles52, as shown inFIGS. 15B-15D. The wedge66may then be retracted back to the position shown inFIG. 15A. It will be appreciated that other stapler mechanisms may be used instead, such as those disclosed in U.S. Pat. Nos. 4,608,981, 4,633,874, 5,104,025, 5,307,976, 5,709,680, and European Patent No. 1,157,666, the entire disclosures of which are expressly incorporated by reference herein.

The deployment of the staples may be sequential within each set, e.g., simultaneously delivering first staples from each of the sets52a-52cat the proximal end of the first jaw46and, as the trigger34continues to be pulled, additional staples are deployed until the desired length of stapling, whereupon actuation may be discontinued, which may leave one or more staples closest to the distal tip46aof the first jaw46undeployed. In this manner, the operator may control how many staples are deployed based on the extent to which the staple actuator is pulled. Alternatively, the actuator34may be binary, i.e., wherein, when the trigger34is initially pulled, all of the staples in the first jaw are deployed in rapid succession.

If the apparatus8includes a Doppler sensor58, e.g., on the second jaw48, the Doppler sensor58may be activated, e.g., using a radar actuator (not shown) on the handle30, to detect blood flow in the stapled tissue. For example, signals from the sensor58may be transmitted, e.g., via one or more wires (not shown) in the shaft20to a processor in the handle30, which may analyze the signals to confirm whether blood flow has discontinued in the stapled tissue. The apparatus8may include an output device, e.g., an indicator light, speaker, and the like (not shown), e.g., on the handle30that may provide a positive indication that blood flow has stopped. The operator may then manipulate another actuator, e.g., a slider, dial, and the like (not shown) on the handle30to advance the blade60to sever the stapled tissue from adjacent tissue.

If the output device indicates that blood is still flowing in the stapled tissue, additional actions may be taken to cauterize the tissue and/or stop blood flow. For example, if the apparatus8includes the thermal element56, the operator may activate the thermal element to deliver thermal energy to the stapled tissue. For example, a button or switch (not shown) on the handle30may be activated to deliver RF energy from a power source coupled to the handle30via one or more wires (not shown) in the shaft20to the electrode(s)56aon the first jaw46to cauterize the stapled tissue. Energy may be delivered until the output device/Doppler sensor58provides a confirmation that blood flow has stopped, whereupon the blade60may be advanced to sever the tissue, e.g., to simultaneously sever the appendix and the appendicular artery.

Optionally, before severing the tissue, the second jaw48may be released and opened and the jaws46,48repositioned relative to the stapled tissue and then closed and locked at one or more subsequent positions, e.g., to use the Doppler sensor58to confirm blood flow has stopped and/or deliver further thermal energy to cauterize the tissue. Once desired, the blade60may be used to sever the tissue.

The apparatus8may then be removed from the surgical space and the procedure completed using conventional methods. For example, the blade60may be retracted, and the Doppler sensor58and/or hemostasis element56may be deactivated (if not already). The end effector40may be removed from the patient's body with the second jaw48remaining locked to remove the excised tissue.

Optionally, the procedure may be illuminated and/or monitored using an illumination source and/or imaging element on the end effector40and/or shaft20, as described elsewhere herein. In addition or alternatively, other light sources and/or imaging devices may be provided to monitor the procedure. For example, a separate endoscope may be introduced into the surgical space, e.g., via a different cannula or port (not shown) than the cannula used to introduce the apparatus8.

In another alternative, a cannula or access port may be provided that includes one or more illumination and/or imaging elements, and the apparatus8may be introduced using the access port. For example, turning toFIGS. 6A-6E, an exemplary embodiment of an access port70is shown that generally includes an elongate tubular body72including a proximal end74, a distal end76sized for introduction into a patient's body, and one or more lumens or passages78extending at least partially between the proximal and distal ends74,76. For example, the tubular body72may include a primary lumen78asized to receive one or more instruments therethrough that extends from an outlet in the proximal end74to an outlet in the distal end76, such as any of the stapler apparatus described elsewhere herein. In addition, the tubular body72may include one or more secondary lumens (not shown), e.g., extending at least partially from the proximal end74towards the distal76, e.g., for receiving actuator elements, wires, and/or other components, as described elsewhere herein. The tubular body72may be substantially rigid or alternatively at least a portion of the tubular body72, e.g., a distal portion, may be malleable or flexible (not shown).

A handle or hub80may be provided on the proximal end74, e.g., to facilitate manipulation of the access port70during use. The hub80may include one or more valves or seals (not shown), which may seal the primary lumen78ayet facilitate inserting an instrument into the primary lumen78a, e.g., providing a substantially fluid-tight seal around the instrument. In this manner, the seal(s) may prevent insufflation gas or other fluid to escape through the primary lumen78a, e.g., when the access port is introduced into a patient's body, as described elsewhere herein.

In addition, a display or other output device82may be provided on the hub80, e.g., to facilitate observing or otherwise monitoring the procedure using one or more imaging devices on the access port80. For example, a distal portion of the tubular body72may include a pair of deployable arms84including first ends84apivotally coupled to the tubular body72and second or free ends84bthat may carry one or more cameras, light sources, and/or other imaging device, as described further below.

In one embodiment, the display82may be removably mountable on the hub80, which may include one or more connectors or cables (not shown) that may be coupled to corresponding connectors on the hub80, which are, in turn, coupled to one or more wires extending to the imaging device(s) on the arms84. Thus, in this alternative, the display82may be reusable and the tubular body72may be disposable/single-use. Alternatively, the display82may be permanently mounted to the hub80and one or more wires or other elements may communicate with the imaging device(s). Thus, in this alternative, the entire access port80may cleaned and reused or may be single-use. In a further alternative, the access port80may include a communications interface that may transmit signals from the imaging device wirelessly, e.g., using Bluetooth or other communications protocols, to allow images to be presented on a remote display.

In an exemplary embodiment, a CMOS, CCD, or other imaging element (not shown) may be provided on the free end84bof one of the arms84and one or more LEDs or other light sources may be provided on the free end84bof the other arm84. Alternatively, separate light sources and imaging elements may be provided on both arms, e.g., to provide multiple images simultaneously on the display82. In a further alternative, only one arm may be provided, if desired, including one or more light sources and/or imaging elements on its free end.

In any of these embodiments, one or more wires may transmit signals from the imaging element(s) to the display82, which may include a processor to process the signals and present the images on a screen of the display82. The imaging element(s) may include a field of view oriented distally beyond the distal end76of the tubular body72, e.g., to illuminate and/or image an instrument deployed within a region beyond the distal end76.

The arms84are movable between a retracted configuration, e.g., as shown inFIGS. 6A and 6D, which may facilitate introduction into a patient's body, and a deployed configuration, e.g., as shown inFIGS. 6B, 6C, and 6E, where the imaging device may be used to acquire images during a procedure. In one embodiment, the arms84may be biased to the retracted configuration, but may be directed to the deployed configuration when an instrument is inserted into the primary lumen78a, as described further below. Alternatively, the arms84may be actuated (or moved) by a user selectively between the retracted and deployed configurations, if desired.

For example, with particular reference toFIGS. 6D and 6E, the first ends84aof the arms84may include ramps or other features84cthat extend partially into the primary lumen78a. Consequently, when an instrument is inserted into the lumen78a, the instrument may contact the ramps84c, thereby deflecting the arms84outwardly to the deployed configuration. As can be seen inFIG. 6E, in the deployed configuration, the ramps84cmay be substantially flush with the wall of the tubular body72such that the ramps84cdo not interfere with manipulation of the instrument. When the instrument is removed, the arms84may return automatically back towards the retracted configuration. Alternatively, the arms84may remain deployed until actuated or until the access port70is removed, e.g., whereupon the arms may be collapsed inwardly as they contact tissue along the exit path. In another alternative, a circumferential light source, such as a circular Xenon LED lamp (not shown) may be provided on the distal end of the access port instead of the arms.

Turning toFIGS. 7A-7D, an exemplary embodiment of a staple or clip90is shown that may be delivered using any of the stapler apparatus herein. Generally, the staple90includes a base92, e.g., a substantially straight segment, from which first and second tines94,96extend, e.g., substantially perpendicular to the base92. The tines94,96may be substantially straight terminating in respective tips95,97. Thus, for example, the base92and tines94,96may define a substantially rectangular “U” shape, e.g., with rounded transitions between the base92and the tines94,96. As shown, the first tine94has a length that is substantially shorter than the second tine96. In addition, the second tine96has a length from the base92to its tip97that is longer than the length of the base92. Consequently, the second tine96may be bent or otherwise deformed towards the first tine94, e.g., as shown inFIG. 7D.

In the example shown, the staple90has a cross section that is substantially uniform along the length of the staple90, e.g., along a length of the first tine94, along the base92, and along the second tine96. For example, the staple may have a substantially rectangular (with or without sharp corners), oblong, or other generally flattened cross-section, e.g., having a width “w” that is thicker than a thickness “t,” as indicted inFIGS. 7A-7D.

In addition, the first tine94includes a notch98adjacent its tip95configured to receive the tip97of the second tine96when it is deformed. For example, as shown, the tip97of the second tine97may be beveled such that the tip97tapers towards the first tine94, which may enhance the tip97being locked into the notch98. Alternatively, as shown inFIG. 8A, the tip97aof the second tine96amay be beveled in the opposite direction, i.e., away from the first tine92a. In addition, or alternatively, the staple may include different ridges for different thickness compression.

Optionally, as shown inFIG. 8C, the first tine94cmay include a plurality of notches98cspaced apart from one another along the length of the first tine94c. Thus, in this embodiment, the tip97cof the second tine96cmay be ratcheted sequentially into the notches98c, e.g., simply locked into the top notch98cor down into one of the notches further down on the first tine94c. Although three notches98care shown inFIG. 8C, it will be appreciated that any desired number of notches (two or more) may be provided on the first tine94c. Alternatively, the first tine may be provided without any notches (not shown), and the stapler actuator may be configured to bend or otherwise deform the tip of the first tine over the second tine (after the second tine has been bent).

In another option, shown inFIG. 8B, a radius of the transition between the base92band the second tine96emay be increased, e.g., compared to the staple90shown inFIG. 7C, which may reduce the force to bend the second tine96eduring use. In yet another option, shown inFIG. 8D, the tip95dof the first tine94dmay include a bevel that is oriented towards the second tine96d(as opposed to being oriented away from the second tine96, as in the staple90shown inFIG. 7C). In still another option, shown inFIG. 8E, a staple90emay be provided that includes a bump93ein the base92e, which may be configured to enhance the pinching/closure of the tissues entrapped within the staples. It will be appreciated that any of these options may be included in one or more of the staples included in any of the stapler apparatus described elsewhere herein.

With additional reference toFIGS. 3A-3C, a plurality of staples, such as staple90shown inFIGS. 7A-7D(or any of the alternatives) may be provided in each of the receptacles52in the first jaw46. With the receptacles52aligned along the axis26of the shaft20, the base92of each staple90may be seated at the bottom of the respective receptacle with the first tine94closer to the distal tip46bof the first jaw46and the second tine96closer to the proximal housing42(or reverse). Consequently, as the staples are deployed upwardly from the receptacles52, both tines94,96may be driven through the tissue adjacent the contact surface46aof the first jaw46, and the second tines96may then be received in the respective recesses54in the second jaw48as the staples are pushed upward toward the second jaw48. This action may facilitate bending the second tines96distally towards the first tines94. Thus, the second tines96may be bent or otherwise deformed above the tissue towards the tips93of the first tines94until the tips97of the second tines96are received in the respective notches98, thereby locking the staples90and compressing the captured tissue.

Turning toFIGS. 9-12, another exemplary embodiment of an access port170is shown that includes an elongate tubular body172and a video module180that may be coupled to the tubular body172, e.g., to allow introduction of one or more instruments through the port170into a surgical space within a patient's body while acquiring images within the surgical space, generally similar to other embodiments herein. As shown inFIG. 10, the tubular body172includes a proximal end174, a distal end176sized for introduction into a patient's body, and one or more lumens or passages178extending between the proximal and distal ends174,176. For example, the tubular body172may include a primary lumen178asized to receive one or more instruments therethrough, such as the stapler apparatus8shown inFIGS. 13A and 13Band/or described elsewhere herein. In addition, the tubular body172includes one or more secondary lumens178b, e.g., positioned within a sidewall of the tubular body172around the primary lumen178a. For example, as best seen inFIGS. 12A and 12B, three secondary lumens178bmay be positioned together on one side of the primary lumen178aand a fourth secondary lumen178bmay be provided on an opposite side of the primary lumen178ato acquire two sets of images simultaneously, as described further elsewhere herein. Outlets179bof the secondary lumens178bat the distal end176may be open or may include a transparent cover, membrane, and the like (not shown) to prevent bodily fluids or other materials from entering the secondary lumens178bfrom the distal end176. The tubular body172may be substantially rigid or alternatively at least a portion of the tubular body172, e.g., a distal portion, may be malleable or flexible (not shown).

The video module180generally includes an annular hub182from which a plurality of elongate sleeves, tubes, or other imaging elements184extend, e.g., provided in an arrangement corresponding to the secondary lumens178bin the tubular body172. The imaging sleeves184may be sized to be inserted into the secondary lumens178bsimultaneously from the proximal end174of the tubular body172such that distal tips184bthereof are disposed adjacent the distal end176of the tubular body172, e.g., extending slightly from the outlets184bfor acquiring images beyond the distal end176.

Optionally, the proximal end174of the tubular body172and the hub182may include cooperating connectors (not shown) to removably couple the hub182to the tubular body172, e.g., such that the access port170may be manipulated as a unitary device.

In addition, one or both of the proximal end174of the tubular body172and the hub182may include one or more valves or seals (not shown), e.g., to seal the primary lumen178ayet facilitate inserting an instrument into the primary lumen178a, e.g., providing a substantially fluid-tight seal around the instrument. In this manner, the seal(s) may prevent insufflation gas or other fluid to escape through the primary lumen178a, e.g., when the access port170is introduced into a patient's body, as described elsewhere herein.

In addition, a display or other output device186may be provided on the hub182, e.g., to facilitate observing or otherwise monitoring the procedure using one or more imaging devices on the access port170. In one embodiment, the display186may be removably mountable on the hub182, which may include one or more connectors or cables (not shown) that may be coupled to corresponding connectors on the hub182. Alternatively, the display186may be permanently mounted to the hub182. In a further alternative, a display may be provided separate from the access port170and images may be transmitted wirelessly or via wired connection from the access port170, similar to other embodiments herein.

Each sleeve184may include an elongate tubular body, e.g., formed from stainless steel or other metal, plastic, and/or composite material including a lumen for carrying one or more imaging components. The sleeves184may be substantially rigid or, alternatively, may be sufficiently flexible to follow the shape of the lumens178b, e.g., if the tubular body172is malleable or flexible and directed to a nonlinear shape.

In an exemplary embodiment, at least one of the imaging sleeves184may carry a CMOS, CCD, or other camera (not shown) on its distal tip184bto acquire the images. Alternatively, a lens may be provided on the distal tip184band a fiberoptic cable or other optical conductor (also not shown) may extend through the imaging sleeve184to the proximal end184a, where the conductor may be coupled to a camera to acquire the images.

Similarly, at least one of the imaging sleeves184may carry an illumination source, e.g., an LED or other light source, on its distal tip184bfor transmitting light beyond the distal end176of the tubular body172. Alternatively, the LED or other light source may be provided within the hub180, and an optical conductor may extend from the proximal end184aof the imaging sleeve184to its display tip184b. In the example shown, the video module180includes a pair of sleeves184on opposite sides of the primary lumen178acarrying cameras on distal tips184(1), and a pair of sleeves184on opposite sides of one of the camera sleeves carrying an LED or other illumination source on the distal tips184(2) (or may carry lenses coupled to cameras or LEDs), e.g., providing a field of view as shown inFIG. 9C. In this configuration, images may be acquired substantially simultaneously from opposite distal tips184b(1) to provide binocular imaging on either side of the end effector40(as shown inFIG. 13B), with the distal tips184b(2) providing off-axis illumination to minimize shadows or otherwise enhance illumination within a surgical space.

During use, the imaging elements184may be inserted into inlets175bfrom the proximal end174of the tubular body172into the corresponding secondary lumens178buntil the distal tips184bare positioned adjacent the distal end176of the tubular body172, e.g., extending a desired distance from the outlets179bto allow acquisition of images. Optionally, when the imaging elements184are fully inserted, connectors on the hub182and/or proximal end174may engage to secure the video module180relative to the tubular body172. The assembled access port170may then be introduced into a patient's body to allow introduction of one or more instruments to be introduced to perform a surgical procedure while acquiring images of the procedure, similar to other embodiments herein. For example, as shown inFIGS. 13A and 13B, an end effector40of a stapler apparatus8may be inserted through the primary lumen178ato staple and/or remove tissue, as described elsewhere herein.

Upon completing the procedure, any instruments may be removed from the primary lumen178a, and the port170may be removed from the patient's body using conventional methods. The video module180may be removed from the tubular body172and then cleaned, sterilized, and/or otherwise prepared for use again in a subsequent procedure. The tubular body172may be single-use, and may be discarded after the procedure. Alternatively, the tubular body172may also be cleaned, sterilized, and/or otherwise prepared for reuse.

Turning toFIG. 14, another exemplary embodiment of a stapler apparatus208is shown that includes a video module280integrated into a reusable shaft/handle portion210. Generally, the handle portion210includes a shaft220extending from a handle230including actuation components (not shown), e.g., such that a disposable end effector (not shown) may be coupled to a distal end224of the shaft220, similar to other embodiments herein.

Unlike the previous embodiments, a plurality of elongate imaging sleeves284also extend from the handle portion210, e.g., from a hub282from which the shaft220also extends. As shown, the imaging sleeves284may be positioned radially around the shaft220and may have a length longer than the shaft220such that distal tips284bof the imaging sleeves284extend distally beyond the distal end224of the shaft220. The video module280may also include a display286mounted on the hub282(or elsewhere on the handle portion210and/or remote from the apparatus280, as desired) coupled to one or more cameras and/or illumination sources (not shown) that may be used to acquire images beyond the distal tips184b.

An end effector (not shown) may be coupled to the distal end224of the shaft220generally similar to other embodiments, e.g., to staple, cauterize, and/or remove tissue. In addition, the housing of the end effector may include a plurality of secondary lumens (also not shown) that may receive the imaging sleeves284such that the distal tips284bare disposed adjacent jaws of the end effector, e.g., similar to the configuration shown inFIG. 13B.

During use, a desired end effector may be received over the imaging sleeves284and coupled to the distal end224of the shaft. Optionally, a cartridge (not shown) may be loaded into one of the jaws of the end effector and then the end effector may be introduced into a patient's body to perform a surgical or other medical procedure, similar to other embodiments herein. IN this manner, the video module280may be used to acquire images during the procedure. Upon completing the procedure, the apparatus208may be removed, the end effector may be removed and, optionally discarded, and the handle portion210may be cleaned and/or otherwise prepared for use in another procedure, also similar to other embodiments herein.

Alternatively, it will be appreciated that other staples or clips may be delivered using any of the stapler apparatus herein, such as those described in the provisional application incorporated by reference herein.

It will be appreciated that elements or components shown with any embodiment herein are exemplary for the specific embodiment and may be used on or in combination with other embodiments disclosed herein. In addition, although the apparatus herein have been described for particular use during an appendectomy procedure. It will be appreciated that the apparatus and methods herein may be used in a variety of surgical procedures, e.g., including open, minimally invasive, laparoscopic, and other procedures, where it is desired to staple and remove target tissues, e.g., within a patient's intestine, lungs, vasculature, and other locations.