SURGICAL SYSTEM INCLUDING A SUPPORT FOR AN INSTRUMENT

A surgical system includes an instrument and a support. The instrument has a tapered handle attached to a head that is sized for insertion into a vagina. The support includes a flexible section connected between a post that is attachable to a surgical table and a cradle configured to removably receive the tapered handle of the instrument. The cradle includes a tapered trough that is sized to receive the tapered handle of the instrument and an engagement feature that secures the tapered handle into the tapered trough.

BACKGROUND

There is a trend to move toward minimally invasive surgical procedures that allow the patient to recover faster. Faster recoveries are associated with less time in post anesthesia and other care units, which can translate to a lower cost of patient care.

Many such minimally invasive surgical procedures are performed laparoscopically through multiple access ports formed in the abdomen. At least one access port is formed to provide access for a camera that allows visualization of the internal organs, and at least one access port is formed to provide access for surgical tools to the internal organs. However, it is often the case that the organ selected for surgical intervention will have a surface that is oriented away from the camera such that the surgeon has an imperfect view of the complete organ.

Surgeons would welcome a new system for manipulating the orientation of internal organs to provide a better view of all surfaces of the organ.

SUMMARY

One aspect provides a surgical system including an instrument and a support. The instrument has a tapered handle attached to a head, with the head sized for insertion into a vagina. The tapered handle has a distal end that is narrower than a proximal end of the tapered handle. The system includes a support having a flexible section that is connected between a post that is attachable to a surgical table and a cradle that is configured to removably receive the tapered handle of the instrument. The cradle includes a base connected to the support and opposed side walls connected to the base. The opposed side walls extend from the base and terminate at an open slot formed in the cradle opposite of the base. The open slot communicates with a tapered trough that is formed longitudinally in the cradle from a proximal end to a distal end of the cradle. The tapered trough has a first inside width between the opposed side walls at the distal end of the cradle that is less than a second inside width between the opposed side walls at the proximal end of the cradle such that the tapered trough is sized to receive the tapered handle of the instrument. The cradle includes an engagement feature that operates to pinch the tapered handle between the opposed side walls of the tapered trough when the tapered handle of the instrument is moved in a distal direction within the tapered trough.

One aspect provides a surgical system including an instrument having a tapered handle attached to a head that is sized for insertion into a vagina. The system includes a support having a flexible section that is connected between a post that is attachable to a surgical table and a cradle that is sized to receive the tapered handle of the instrument. The cradle includes a tapered trough that is formed longitudinally in the cradle from a proximal end to a distal end of the cradle. The tapered trough has taper angle that is substantially equal to a taper angle of the tapered handle such that the tapered trough is shaped to frictionally receive the tapered handle of the instrument. Both the proximal end of the tapered handle and the head of the instrument are wider than an inside width of the tapered trough. The cradle includes an open slot that allows the tapered handle to be inserted into the tapered trough of the cradle. The cradle includes an engagement feature that pinches the tapered handle between opposed side walls of the tapered trough.

DETAILED DESCRIPTION

Anterior means “forward” or “front,” and posterior means “rearward” or “back.” Relative to surfaces of an organ in the human body, an anterior surface of an instrument inserted into the organ will be oriented forward toward the belly and a posterior surface will be oriented rearward toward the spine.

Embodiments provide a surgical system including a support and an instrument that is useful in manipulating an internal pelvic organ. The surgical instrument includes a head attached to a handle, where the head is insertable into the vagina and the handle is useful in moving the head to manipulate the vagina for repair of the vaginal wall. The support is provided to hold the instrument at the location selected by the surgeon after the head of the instrument has been adjusted to manipulate a wall of the vagina. Typically, a surgical assistant hold an inserted instrument at its location within the vagina, which can lead to fatigue for the assistant. The system provides an improved surgical procedure that reduces fatigue the surgical staff and has the potential to improve surgical outcomes.

The system includes a cradle that secures the instrument to the support. The cradle is configured to allow the instrument to be removed by moving the instrument in a direction away from the patient, and advantageously, is also configured to prevent movement of the instrument in a direction closer (or further into) the patient.

The system is useful in gynecological, colorectal and other procedures. The instrument may be manually deployed into an organ during an open procedure, or the head of the instrument may be employed in a laparoscopic procedure or robotically manipulated in a robotically-assisted surgical procedure.

For example, in a laparoscopic procedure a camera system is inserted into a camera port formed through the wall of the abdomen to allow visualization of the internal organs. Other ports are formed in the abdomen to allow tools and devices to access a selected organ. The selected organ will have a surface oriented toward the camera (an anterior surface) and a surface away from the camera (a posterior surface). The head of the instrument is provided with a hinged movable plate that operates to present or displace the posterior surface of the selected organ in a direction for improved visualization by the camera. This feature is particularly useful when manipulating a posterior wall of the vagina that is typically oriented to face away from the abdomen and away from a camera that is inserted into the abdomen laparoscopically.

FIG. 1is a perspective view of one embodiment of a surgical system20. The surgical system20(system20) includes an instrument22removably attached to a support24. The instrument22includes a tapered handle30that converges to a distal end32that is attached to a head34. The support24includes a flexible section40that is connected between a post42that is attachable to a surgical table and a cradle44that is configured to removably receive the tapered handle30of the instrument22.

The instrument22is securely held within the cradle44during the surgical procedure. The flexible section40is configured to allow the instrument to be moved to a desired location, and thereafter maintain the instrument at the desired location. The flexible section40is movable relative to3major axes to provide a pitch movement (up-and-down) for the instrument22, a yaw movement (left and right) for the instrument22, and a roll movement (around a longitudinal axis of the handle30) for the instrument22. The flexible section40is suitably fabricated from a set of nested components, where each nested component is movable relative to its neighbor. One such suitable flexible section is available from JOBY, San Francisco, Calif.

The post42is sized and configured to be attached to a surgical table. In one embodiment, the post42is provided as a stainless steel rod or peg having a diameter of about ⅝ inch, although other diameter sizes are also acceptable. The post42may be suitably fabricated from other materials, such as plastics or resins.

During use, for example when assisting in a laparoscopic surgical procedure to repair a prolapsed vagina, the surgeon will secure the instrument22to the cradle44and insert the head34into the vagina. The cradle44holds the instrument22securely, but is configured to allow the instrument22to be released from the cradle44. The head34is operable to maneuver the walls of the vagina to a desired position that orients the vagina in its natural location and allows the subsequent attachment of support material to the vagina. The support24is provided to hold the instrument22at the position selected by the surgeon, and this relieves the surgeon's assistant from the task of holding the instrument22. The flexible section40provides multiple degrees of motion so as to allow the surgeon to freely maneuver the instrument22.

FIG. 2is a perspective view of one embodiment of the instrument22. The instrument22includes a control knob50(or actuator50) located at a proximal end52of the tapered handle30. The control knob50is attached by a suitable driving mechanism to a hinged plate60that is attached to head34. Rotating the control knob50moves the hinged plate60away from the head34, and alternatively, toward the head34.

The handle30is tapered to converge from the proximal end52toward the distal end32. The handle30is wider at the proximal end52as compared to the distal end32. For example, a first diameter D1 at the distal end32is sized to be less than a second diameter D2 at the proximal end52. An approximate mid-portion53of the handle30is narrower than the proximal end52but wider than the distal end32.

The tapered handle30includes a planar indentation54provided on each lateral side of the handle30. The planar indentation54is formed as a relief that is carved out of the tapered handle30. The indentation54may be molded into the handle30or milled out of the handle30. The planar indentation54provides an engagement surface for the cradle44(FIG. 1) to pinch or impinge against, which operates to couple the tapered handle30securely to the cradle44. The planar indentation54has a length L that extends the longitudinal length of the relief portion that is carved from the tapered handle30.

The handle30is rigid and provided so that the handle30does not bend as the surgeon is manipulating the organ inside the patient. In this regard, the surgeon might apply a force to the handle30between1-10pounds and the handle30is fabricated to be rigid to exhibit substantially zero strain in response to this level of stress applied to the handle30during tissue manipulation.

The head34includes an anterior surface62opposite a posterior surface64. The hinged plate60has a distal side66(a front side) that is attached to a distal portion68(or a front portion) of the head34by a hinge70. The hinged plate60is referred to as a kick out door and operates to displace the posterior wall of the vagina for better visualization during a laparoscopic procedure. In particular, the posterior surface64of the head34will be oriented toward the patient's sacrum during use, and the hinged plate60moves to push the posterior wall of the vagina into the surgeon's line of sight during the laparoscopic procedure.

The hinged plate60swings or moves relative to the hinge70. The hinge70attaches the distal, front side66of the plate60to the distal, front portion68of the posterior surface64of the head34. The cantilevered motion of the door60relative to the head34is controlled by the control knob50at the opposite end of the instrument22. The actuator knob50is connected to a movable arm72that is attached between the hinged plate60and the head34. The rotation of the control knob50is converted into translational movement of the movable arm72by the driving mechanism (SeeFIG. 9), which results in the hinged plate60moving away from (or toward) the posterior surface64of the head34.

FIG. 3is a side view,FIG. 4is a perspective view, andFIG. 5is a cross-sectional view of one embodiment of the cradle44. The cradle44includes a base73that connects with the support24and opposed side walls74,75connected to the base73. The opposed side walls74,75extend from the base73and terminate at an open slot76formed in the cradle44opposite of the base73. The open slot76communicates with a tapered trough80that is formed longitudinally in the cradle44.

The trough80extends from a proximal end82to a distal end84of the cradle44. The trough80is tapered and converges toward the distal end84such that the trough80provides a complementary shape to receive the tapered handle30(FIG. 2).

The converging trough80has an interior surface86that narrows from a wider dimension D3 at the proximal end82down to a narrower dimension D4 at the distal end84. The interior surface86has a first distal pad90and a second distal pad91that each project away from an interior lateral wall of the interior surface86. The distal pads90,91are located in a front portion of the trough80. Adjacent to the proximal end82, the interior surface86has a first proximal pad94and a second proximal pad95that each project away from an interior lateral wall of the interior surface86. The distal pads90,91and the proximal pads94,95each have a height projecting from the interior surface86that configures the tapered trough80to clasp the planar indentation on each lateral side of the tapered handle30. The distal pads90,91and the proximal pads94,95provide an engagement feature for the cradle44and are adapted to engage with a respective one of the planar indentations54(FIG. 2) that is formed in the tapered handle30.

The trough80is tapered to converge toward the distal end84. In one embodiment, the exterior surface of the cradle44is provided in a cylindrical shape having parallel opposed exterior walls. In one embodiment, an exterior surface96of the cradle44also converges from the proximal end82toward the distal end84as illustrated inFIG. 5. The tapered and converging nature of the exterior surface96is represented by the angle of taper A1, where the angle of taper A1 is in a range between 2-10 degrees. In one embodiment, the angle of taper A is about 6 degrees. The tapered and converging nature of the trough80is represented by the angle of taper A2, where the angle of taper A2 is in a range between 7-20 degrees. In one embodiment, the angle of taper A is about 11 degrees.

The converging tapered trough80is fabricated to have a complementary shape to receive the tapered handle30of the instrument22(FIG. 2). The tapered trough80is formed longitudinally in the cradle44from the proximal end82to the distal end84, and the tapered trough80has taper angle A that is substantially equal to a taper angle of the tapered handle30at the mid-potion53(FIG. 2) such that the tapered trough80is shaped to frictionally receive the tapered handle30of the instrument22.

With reference toFIG. 5, the pads90,91are spaced a distance apart from the pads94,95to configure the pads to engage with the planar indentation54(FIG. 2) provided on the handle30. For example, in one embodiment a distal most end of the distal pads90,91is spaced a distance L2 apart from a proximal most end of the proximal pads94,95, and the distance L2 is selected to be approximately equal to the length L of the planar indentation54(FIG. 2). With this configuration, movement of the tapered handle30in a distal direction within the trough80secures the instrument22to the cradle44by seating the distal pads90,91to a front location of the planar indentation54and seating the proximal pads94,95to a rear location of the planar indentation54. The pads90,91and94,95are sized to frictionally engage with the planar indentation54such that the instrument22will snap-fit within the cradle44.

The engagement feature pads90,91and planar section54combine to lock the tapered handle30into the tapered trough80to prevent forward proximal motion of the head34of the instrument into the vagina. The instrument22is removable from the cradle44without having to push the instrument22closer to the patient. In other words, the cradle44is advantageously designed to allow for removal of the instrument22from the cradle44with movement in the proximal direction (toward the surgeon) that moves the instrument22away from the patient.

Suitable materials for fabricating the cradle44include metal such as stainless steel, plastics such as nylon or acrylonitrile butadiene styrene (ABS) or the like, or resins. The instrument22is sterilizable and configured for use as a disposable surgical instrument. Fabricating the instrument from stainless steel configures the instrument to be sterilizable and reusable.

FIG. 6is a schematic view of the system20coupled to a surgical table T. The post42is secured to a holder provided that is usually provided on a surgical table T and the tapered handle30of the instrument22is secured into the cradle44. The flexible section40is movable relative to the table and allows the cradle44to move in all of the cardinal directions in three-dimensional space including. The freedom of motion of the cradle44allows the instrument22to translate in space, to pitch P up/down on its longitudinal axis, or yaw Y left/right on its longitudinal axis, or roll R about on its longitudinal axis.

Both the proximal end52of the tapered handle30and the head34of the instrument22are wider than the widest inside width (D3) of the tapered trough80(FIG. 5). The open slot76is sized to allow the mid-portion53of the tapered handle30to be inserted into the tapered trough80of the cradle44. The narrower distal portion of the tapered handle30is inserted into the open slot76of the cradle44, and the instrument22is pushed toward the table T until the mid-portion53of the tapered handle30is engaged or pinched or secured or locked into the cradle44. The forward or distal movement of the instrument22relative to the table T operates to lock the tapered handle30into the cradle. The rearward or proximal movement of the instrument22toward the surgeon operates to unlock the instrument22from the cradle44. The system20is adapted to allow the instrument22to disengage from the cradle44when the instrument22is moved rearward, for example in response to movement of the patient. In this manner, the instrument22is adapted to release and give way so that undue force or discomfort is not delivered to the patient.

FIGS. 7-8are schematic views of the system20employed to internally manipulate an orientation of the vagina V of the patient during a laparoscopic procedure.FIGS. 7-8represent the related anatomy but are not drawn to scale. The laparoscopic procedure may be of the robotically-assisted type of laparoscopic procedure. The instrument22is suited for manual use in dissecting tissues off of the vagina V and in manipulating the orientation of the vagina V. Although features of a laparoscopic vaginal procedure are described below, it is to be understood that the system20is suitable for manually manipulating the vagina or other pelvic organs in other surgical procedures, including other robotic procedures and the like.

FIGS. 7-8are schematic views of internal organs of a supine patient with the head34of the instrument22in position for insertion into the vagina V. A natural vagina has an entrance and terminates at the cervix, which communicates with the uterus. Some women have their uteruses removed through a hysterectomy, and some of these procedures result in the presence of a cervical stump CS connected to the vagina V as illustrated. The bladder B communicates with the urethra U and is located anterior to the vagina V and posterior to the pubic bone PB. The digestive tract and the rectum are located posterior to the vagina V. The sacrum S and the coccyx C are located posterior to the digestive tract (rectum). The abdominal wall AB protects and supports the internal organs.

During a laparoscopic surgical procedure, one or more access ports are formed through the abdominal wall AB (usually supported by a trocar) to allow a visualization camera and tools to access the internal organs. In the illustrated embodiment, a first trocar110provides an access port for surgical tools and a second trocar112provides an access port for an optical camera114. One or more additional ports (for example a nitrogen inflation port) may be provided through the abdominal wall AB in what is traditionally described as a trans-abdominal approach to the vagina V.

The system20is secured to the table T and is used to dissect vesico-vaginal tissue away from a wall of the vagina V. One or more surgical tools are inserted through the trocar110toward the vagina V. The surgeon moves the head34of the instrument22to a desired location to position the vagina V for surgery and the support24holds the instrument22in the selected location. The head34is sized to manipulate the vagina V and to displace portions of the wall of the vagina, which allows the surgeon to progressively dissect the vesico-vaginal tissue122between the bladder B and the anterior wall120of the vagina V. It is desirable to expose the anterior wall120of the vagina V to allow the surgeon to optimally orient the vagina V when addressing prolapse and in improving support provided to the vagina V, for example during a sacrocolpopexy procedure.

The plate60of the head34is movable to dissect recto-vaginal tissue away from a wall of the vagina V. The surgeon employs the handle30to provide a slight lifting force to the vagina V and the support24maintains this force and the location of the instrument22. Suitable other tools are employed to dissect the recto-vaginal tissue from between a posterior wall124of the vagina V and a sheath or other tissue layers attached to the rectum. Although not shown, the instrument22is also useful for manipulating the vagina V to allow the surgeon to relieve the uterosacral ligament and to access and relieve other connective tissues attached between the vagina V and other organs.

After appropriate dissection the anterior wall120and the posterior wall124of the vagina V will be separated from the bladder/rectal connective tissue, respectively. Organs and tissue inside of the abdomen can obstruct the surgeon's view of the vagina V. The head34of the instrument22advantageously provides a backboard or surface that supports the anterior wall120of the vagina to allow the surgeon to suture or otherwise surgically intervene in repairing the vagina V.

FIG. 8is a schematic view of the vagina after the anterior wall120and the posterior wall124of the vagina V have been separated from the bladder/rectal connective tissue, respectively.

The posterior wall124of the vagina V, and in particular, the distal posterior wall of the vagina V in the direction of the vaginal opening, is typically impeded by other tissues and hidden from the view of the surgeon during laparoscopic surgery. The hinged plate60has been pivoted away from the posterior surface64of the head34to move (or “kick out”) the posterior wall124of the vagina V into the line of sight130of the camera114that is positioned trans-abdominally.

FIGS. 9-10are cross-sectional views of one embodiment of a system200. The system200includes the instrument22and a support204with a locking mechanism206securing the support204to the handle30of the instrument22.

FIG. 9illustrates the locking mechanism206engaged in a locked state that operates to lock the support204in place.

The instrument22is as described above and includes the tapered handle extending between the control knob50and the head34. The driving mechanism210is connected between the control knob50and the hinged plate60and operates to translate the rotational movement of the control knob50(FIG. 2) into movement of the hinged plate60.

The support204includes a flexible section220that extends between a rod222that is attachable to a surgical table and a cradle224that receives the tapered handle30of the instrument22. The dimensions of the cradle224are similar to the cradle44described above. In this regard, the cradle224is a tapered configuration that is complementary to the tapered shape of the handle30.

The locking mechanism206includes a keeper230connected between the rod222and the cradle224, and a release lever232that is secured to a lower portion of the cradle224by a pivot234. The keeper230is one of a flexible rod or a braided cable. The keeper230projects through the rod222to a base flange240on one end and extends to an opposite end that is attached to flanges241and242. The flange241is a movable flange and the flange242is a fixed flange that is fixed to the walls of the flexible section220. The movable flange241is biased relative to the fixed flange242by a spring244.

The locking mechanism206is provided as a spring applied pressure release locking mechanism. The locking mechanism206is illustrated inFIG. 9in the closed or locked state with the lever232in a down position. In the closed or locked state the flexible section220is maintained in a rigidly stiff configuration that locks or holds the support204in a position selected by the surgical staff. The handle232pivots about pivot234and the spring244forces the movable flange241upwards toward the cradle224to create tension in the keeper230. In this manner, the flexible section220is placed under tension between the rod222and the cradle224, which locks the segments of the flexible section220and reduces its flexibility.

FIG. 10illustrates the locking mechanism206in an open or unlocked position. The lever232has been moved to the up position which moves the movable flange241and the keeper230downward, which allows the keeper230to become slackened. The slack in the keeper230allows the segments of the flexible section220to move relative to each other, which allows the surgical staff to selectively position the instrument22held in the cradle224.