US20140025048A1 - Single operator medical device handles and related methods of use - Google Patents

Abstract

The invention is directed to improved handles for medical devices. Embodiments of the invention include handles that allow for the device's introduction, positioning, and actuation with a single hand of an operator, handles that allow an operator to simultaneously position and manipulate two devices relative to each other as well as relative to an additional medical device, such as an endoscope, and handles that allow an operator to simultaneously manipulate an endoscope and an additional medical device without the help of an assistant.

Description

FIELD OF THE INVENTION
• This invention relates to handle assemblies for medical devices and related methods of use. More particularly, embodiments of the invention relate to improved handles for actuating and positioning medical implements by a single operator including, for example, positioning multiple medical implements relative to each other during a medical procedure.
BACKGROUND OF THE INVENTION
• Medical devices having elongated body portions can be introduced through a body opening, cavity, or tract and manipulated to remove material from within the body. Such medical devices can be positioned at a treatment site through an elongated endoscope or a laparoscope, which allows an operator to simultaneously view and operate at a remote surgical site. In the field of urology, medical retrieval devices, such as collapsible baskets, graspers and the like, are used to retrieve various foreign or biological materials (e.g., kidney stones, urinary calculi, choleliths, etc.) from within a body. In certain urological procedures, a retrieval device is used to immobilize kidney stones relative to a laser fiber, which is used to fragment stones into smaller pieces for retrieval and removal by the retrieval device, for example.
• Medical retrieval devices can include a sheath and an object-engaging unit, such as a basket, that is moveable relative to the sheath from a collapsed state within the sheath to another state in which the unit extends past the distal end of the sheath. The sheath typically extends from a handle, located at the proximal end (i.e., the end away from the patient) of the sheath to the object-engaging unit which is located at the distal end of the sheath (i.e., the end near the patient and that goes into the patient). The handle includes a mechanism for actuating the object-engaging unit in order to move the object-engaging unit between collapsed and extended, expanded states.
• During a urological procedure, a physician needs to be able to move the distal end of the medical retrieval device in relation to the distal end of a ureteroscope. This may be accomplished by the physician gripping the sheath just proximal to the point where the retriever sheath is introduced into an auxiliary channel within the ureteroscope. As the physician operates the ureteroscope and positions the sheath of the retrieval device, an assistant actuates the handle at the physician's direction to retrieve foreign material.
• In procedures that utilize a laser fiber and retrieval device, the physician must carefully hold and reposition both items relative to each other as well as relative to the ureteroscope. Currently, an operator must manipulate and actuate each device individually or with the assistance of another operator. Such procedures can become overly time consuming and cumbersome.
• In light of the foregoing, there is a need for an improved handle for a medical retrieval device that allows for the device's introduction, positioning, and actuation with a single hand of an operator. There is also a need for an improved handle that allows an operator to simultaneously position and manipulate two devices relative to, each other as well as relative to an endoscope. In addition, there is a need for an improved handle that allows an operator to simultaneously manipulate an endoscope and manipulate an additional medical device without the help of an assistant.
SUMMARY OF THE INVENTION
• Accordingly, the present invention is directed to improved handles for a medical device, and related methods of use that obviate one or more of the limitations and disadvantages of the prior art medical device handles.
• One embodiment of the invention is directed to a medical device including a sheath having a lumen, a distal end, and a proximal end. The device further includes an end effector unit and an elongate member connected to the end effector unit and extending proximally from the end effector unit within the lumen of the sheath. The end effector unit and sheath are movable relative to each other to achieve a first state of the end effector unit when the end effector unit is within the lumen of the sheath and a second state when the end effector unit extends from the distal end of the sheath. A handle is connected to the proximal end of the sheath and a proximal end of the elongate member. The handle comprises an actuating lever to selectively actuate the end effector unit between the first and second states. The handle is configured to allow a single hand of an operator to simultaneously be positioned to actuate the end effector unit via the actuating lever and grasp and manipulate the sheath.
• In various embodiments, the medical device may include one or more of the following additional features: an end effector unit comprising a basket having a plurality of legs where the basket is collapsed in the first state and expanded in the second state; the elongate member is a wire connected to a proximal end of the end effector unit; the actuating lever includes a first portion connected to the handle and a second portion formed at an angle to the first portion; upon actuation, the second portion of the actuating lever engages and moves an internal portion of the handle for movement of the end effector unit between the first and second states; the actuating lever includes a first end connected to the handle and a mid-portion resiliently bowed away from the handle; a ring disposed along an exterior surface of the handle and positioned to accommodate a first finger of an operator's hand; the ring is disposed along an exterior surface of the handle about 90° relative to the actuating lever; and the ring is positioned relative to the actuating lever to permit a second finger of the operator's hand to actuate the actuating lever when the first finger is within the ring; where the ring is positioned relative to the actuating lever to permit a third finger of the operator's hand to grasp and manipulate the sheath when the first finger in within the ring and the second finger actuates the actuating lever.
• Another embodiment of the invention is directed to a method for operating a medical device to perform an operation in a body. The method includes providing a medical device including a sheath including a lumen, a distal end, and a proximal end. The device further includes an end effector unit and an elongate member connected to the end effector unit and extending proximally from the end effector unit within the lumen of the sheath. The end effector unit and sheath are movable relative to each other to achieve a first state of the end effector unit when the end effector unit is within the lumen of the sheath and a second state when the end effector unit extends from the distal end of the sheath. A handle is connected to the proximal end of the sheath and includes an actuating lever. The method further comprises grasping the handle with a hand of an operator in a position to activate the lever; grasping the sheath with the hand grasping the handle; advancing the sheath with the hand grasping the handle to position the end effector unit near a treatment site; and actuating the actuating lever of the handle to selectively actuate the end effector unit between the first and second states.
• In various embodiments, the method may include one or more of the following additional features: manipulating material with the end effector unit at the treatment site; providing an end effector unit comprising a basket having a plurality of legs; a ring disposed along an exterior surface of the handle and, upon grasping the handle, the operator grasps the handle with a single hand and positions a first finger of the single hand within the ring; the operator grasps the handle and positions a second finger of the single hand for actuation of the actuating lever; the operator grasps the sheath with at least a third finger of the single hand in combination with another finger to grasp and manipulate the sheath; and the ring is disposed along an exterior surface of the handle about 90° relative to the actuating lever.
• Another embodiment of the invention is directed to a medical device comprising an elongated handle body defining a longitudinal axis and first and second ports extending along a side of the handle body. The first and second ports are configured to receive first and second elongated medical devices respectively. A movable internal grip is movable along the longitudinal axis of the handle body and the movable internal grip is disposed within the first port. The first port is configured to receive the first elongate medical device and move the first elongated medical device relative to the handle body. A stationary internal grip is disposed within the second port and is configured to receive the second elongated medical device and hold the second elongated medical device stationary relative to the handle body.
• In various embodiments, the medical device may include one or more of the following additional features: the first elongated medical device is a lithotriptor and the second elongated medical device is a tissue retrieval device; the first and second ports are recesses defined by the handle body and accessible along an external surface of the handle body; a finger slide disposed external to the handle body and connected to the movable internal grip; a biasing member inside the handle body between the movable internal grip and a forward end of the handle body for providing resistance to forward movement of the movable internal grip; multiple stationary internal grips disposed within the second recess port; an actuating mechanism to actuate an end effector unit of the second elongated medical device; and the actuating mechanism extends from the handle body in a direction perpendicular to the longitudinal axis of the handle body.
• In another embodiment, the invention is directed to a method for performing an operation in a body, comprising providing a handle including an elongated handle body defining a longitudinal axis and first and second ports extending along a side of the handle body. The handle includes a movable internal grip movable along the longitudinal axis of the handle body and disposed within the first recess port. A stationary internal grip is disposed within the second port. The method further comprises inserting a first medical device within the first port and engaging the first medical device with the movable internal grip; inserting a second medical device within the second port and engaging the second medical device with the stationary internal grip; and moving the first medical device relative to the handle body and the second medical device by longitudinal movement of the movable internal grip.
• In various embodiments, the method may include one or more of the following additional features: positioning the first and second medical devices at a treatment site relative to a distal end of an endoscope; inserting the first and second medical devices into a channel of the endoscope; the first medical device is a lithotriptor and the second elongated medical device is a tissue retrieval device; providing a biasing member inside the handle body between the movable internal grip and a forward end of the handle body for providing resistance to forward movement of the movable internal grip; providing an actuating mechanism to actuate an end effector unit of the second medical device; and providing the actuating mechanism to extend from the handle body in a direction perpendicular to the longitudinal axis of the handle body.
• In another embodiment, the invention is directed to a medical device, comprising a sheath including a lumen, a distal end, and a proximal end, an end effector unit and an elongate member connected to the end effector unit and extending proximally from the end effector unit within the lumen of the sheath, the end effector unit and sheath movable relative to each other to achieve a first state of the end effector unit when the end effector unit is within the lumen of the sheath and a second state of the end effector unit when the end effector unit extends from the distal end of the sheath. The medical device further includes a handle connected to the proximal end of the sheath and a proximal end of the elongate member. The handle comprises an actuator to selectively actuate the end effector unit between the first and second states, wherein the handle is configured for releasable engagement with an endoscope.
• In various embodiments, the medical device may include one or more of the following additional features: a device port defining an internal lumen extending through the handle along a longitudinal axis; wherein the actuator extends along an axis transverse to the longitudinal axis of the internal lumen; wherein upon engagement of the handle with an endoscope, the internal lumen of the device port communicates with an internal lumen of the endoscope; wherein movement of the actuator along the axis transverse to the longitudinal axis of the internal lumen actuates the end effector unit between the first and second states; wherein the actuator includes a plunger; wherein a spring biases the actuator toward a position corresponding to the first state of the end effector unit; wherein the sheath is within the internal lumen of the device port and beyond a distal end of the handle; a second device port defining a second internal lumen extending through the handle along a second longitudinal axis substantially parallel to the longitudinal axis of the internal lumen; a lithotriptor within the second internal lumen of the second device port beyond a distal end of the handle; wherein the handle includes a connector configured for threaded, snap fit, or a male/female connection engagement with an endoscope.
• In another embodiment, the invention is directed to a method for operating a medical device to perform an operation in a body comprising, providing a medical device comprising, a sheath including a lumen, a distal end, and a proximal end, an end effector unit within the lumen of and movable relative to the sheath, a handle connected to the proximal end of the sheath, the handle including an actuator to actuate the end effector unit. The device includes a device port defining an internal lumen extending through the handle and a connector configured for releasable engagement with an endoscope releasably connecting the handle to an endoscope such that the internal lumen of the device port communicates with an internal lumen of the endoscope. The method includes inserting the distal end of the sheath through the internal lumen of the device port and through the internal lumen of the endoscope, advancing the distal end of the sheath outside of the endoscope at a medical treatment site, and actuating the actuator of the handle to actuate the end effector unit.
• In various embodiments, the method may include one or more of the following additional features: wherein the internal lumen of the device port extends along a longitudinal axis substantially parallel to a longitudinal axis of the endoscope; wherein the handle includes a housing for the actuator, the housing and actuator extending along an axis substantially perpendicular to the longitudinal axis of the at least one device port; wherein actuating the actuator includes movement of the actuator along an axis traverse to the longitudinal axis of the internal lumen of the device port; manipulating material with the end effector unit at the treatment site; inserting a second medical device through an internal lumen of a second device port of the handle along a longitudinal axis substantially parallel to the longitudinal axis of the internal lumen of the device port and advancing the second medical device through the internal lumen of the endoscope and to a position outside of the endoscope at a medical treatment site; and wherein the second medical device is a lithotriptor and the method further comprises treating material with the lithotriptor at the treatment site.
• Additional objects and advantages of the invention will be set forth in part in the description which follows, and in part will be obvious from the description, or may be learned by practice of the invention. The objects and advantages of the invention will be realized and attained by means of the elements and combinations particularly pointed out in the appended claims.
• It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed.
BRIEF DESCRIPTION OF THE DRAWINGS
• The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and together with the description, serve to explain the principles of the invention.
• FIG. 1A illustrates a side partial cross-sectional view of a single operator retrieval device handle in an open position, according to an embodiment of the present invention.
• FIG. 1B illustrates the single operator retrieval device ofFIG. 1A in a closed position.
• FIG. 1C illustrates an alternative configuration for a single operator retrieval device handle, according to another embodiment of the present invention.
• FIG. 2A illustrates a side, partial cross-sectional view of a single operator retrieval device handle having a living hinge actuation mechanism in an open position, according to a further embodiment of the present invention.
• FIG. 2B illustrates the single operator retrieval device handle having a living hinge actuation mechanism ofFIG. 2A in an open position.
• FIG. 3 is a side, partial cross-sectional view of a single operator retrieval device handle having an alternative actuation mechanism, according to a still further embodiment of the present invention.
• FIG. 4A illustrates an operator positioning a retrieval device according to an embodiment of the present invention in an open position.
• FIG. 4B illustrates an operator positioning a retrieval device according to an embodiment of the present invention in a closed position.
• FIG. 5 illustrates an alternative handle, according to another embodiment of the present invention, for connection and movement relative to an endoscope.
• FIG. 6 illustrates a handle for moving multiple medical implements relative to each other during a procedure, according to an embodiment of the present invention.
• FIG. 7 is a side cross-sectional view of the handle ofFIG. 6.
• FIG. 8 is an alternative view of the handle ofFIG. 6.
• FIG. 9 illustrates an alternative handle embodiment including an actuation mechanism.
• FIG. 10 illustrates an alternative handle, according to another embodiment of the present invention, for connection to an endoscope.
• FIG. 11A is a partial side cross-sectional view of the handle ofFIG. 10 in a non-actuated position.
• FIG. 11B is a partial side cross-sectional view of the handle ofFIG. 10 in an actuated position.
• FIG. 12 illustrates the handle ofFIG. 10 having an end effector unit in a deployed configuration.
DESCRIPTION OF THE EMBODIMENTS
• Reference will now be made in detail to the present exemplary embodiments of the invention illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
• Referring toFIGS. 1A and 1B, one embodiment of a medical device, according to the invention, includes ahandle10, asheath14, and anend effector unit12.Sheath14 may be flexible and includes an internal lumen for receiving the proximal end of theend effector unit12. As will be described more in detail below, theend effector unit12 andsheath14 are movable relative to each other in order to achieve a first collapsed state of the end effector unit12 (seen inFIG. 1B) in which theend effector unit12 is collapsed within the lumen of the distal end of thesheath14 and a second state in which theend effector unit12 extends from the distal end of thesheath14 and expands (seen inFIG. 1A).End effector unit12 may comprise a basket, grasper, snare, any other retrieval or grasping mechanism, or any other mechanism for performing an operation in a body and may be suitable for urological, endoscopic, or other like procedures.Unit12 is illustrated as a basket having a plurality of legs.
• FIG. 1A illustrates thathandle10 andsheath14 extend along the samelongitudinal axis20.Handle10 further includes anelongated handle body15 housing an actuation mechanism. Theend effector unit12 extends distally from an elongated member disposed within the lumen ofsheath14. The elongated member extends proximally from theend effector unit12 into thehandle body15 and may be in the form of a flexible shaft, coil, cable, or wire. In one configuration, the proximal end of the elongated member is connected to a movable internal portion of thehandle body15, such that movement of the movable internal portion will move theend effector unit12 relative tosheath14 between expanded and collapsed states. This configuration is shown inFIGS. 1A-1B. In another configuration not shown, the proximal end of thesheath14 may be connected to a movable internal portion of thehandle body15, such that movement of the movable internal portion will extend thesheath14 over theend effector unit12 and thereby collapse theend effector unit12.
• Handle10 is gripped in the palm of an operator and may include a finger ring16 (also shown inFIGS. 4A-4B) to assist in handling. Handlebody15 further includes anactuating lever18 attached near a distal end of thehandle body15 by means of ahinge spring22. The actuatinglever18 extends longitudinally along thehandle body15 and is biased, byhinge spring22, to a rest position extending at an angle above thehandle body15. The actuatinglever18 bends about anactuating lever pivot24 and extends proximally internal to the handle body through anopening27, as represented inFIGS. 1A-1B.
• The portion of actuatinglever18 proximal of theactuating lever pivot24 includes engagingteeth26 which cooperatively interfit with the teeth of apinion gear28 disposed internally within thehandle body15. The interior ofhandle body15 includes adrive block30 which is connected to the proximal end of the elongated member extending fromunit12. Thepinion gear28 engages thedrive block30 in order to impart movement to thedrive block30 upon actuation of the actuatinglever18. Movement ofblock30, as described below, actuatesunit12 between the expanded and collapsed states. Upon actuation, thedrive block30 advances and retracts along internal guide rails32.
• An operator actuates the actuatinglever18 by moving the actuatinglever18 abouthinge spring22 in a direction generally normal to thelongitudinal axis20 of thehandle10 andsheath14. As seen in the example ofFIG. 1B, upon actuation,drive block30 moves theend effector unit12 proximally toward the collapsed state withinsheath14.
• FIG. 1C illustrates analternative handle configuration10′ having afinger spool16′. InFIG.1C actuating lever18′ is attached near a proximal end of thehandle body15′ by means of a hinge spring (not shown). The actuatinglever18′ extends longitudinally along thehandle body15′ and is biased, by the hinge spring, to a rest position extending at an angle above thehandle body15′. In the configuration ofFIG. 1C, thedrive block30′ andpinion gear28′ are disposed near the distal end of thehandle body15′. Otherwise the embodiment shown inFIG. 1C has a similar construction and operation as the embodiment ofFIGS. 1A-1B.
• FIGS. 2A-2B illustrate anotherhandle10″ having an actuation mechanism alternative to the configurations ofFIGS. 1A-1B andFIG. 1C. In the embodiment ofFIGS. 2A-2B, the portion of actuatinglever18″ proximal of theactuating lever pivot24″, includes anactuating lever pin34, which moves within agroove36 formed in a side of the proximal portion ofhandle body15″. In this embodiment, handle10″ may include adrive hub31 which is connected to the proximal end of the elongated member extending fromunit12.
• Upon actuation, the proximal or rearward movement of actuatinglever pin34 is resisted by aninternal spring38. The resistance provided byspring38 provides tactile feedback to the operator for better control of the end effector expansion.FIG. 2A shows the actuatinglever18″ at a rest position extending along the longitudinal axis of thehandle body15″ and extending above thehandle body15″ at an angle. This position corresponds to the extended, expanded position forend effector unit12.FIG. 2B shows actuation of the actuatinglever18″ in a direction generally normal to the longitudinal axis of thehandle10″ andsheath14. As seen in the example ofFIG. 2B, upon actuation, drivehub31 moves theend effector unit12 proximally toward the retracted, collapsed state withinsheath14.
• FIG. 3 illustrates anotherhandle10″′ having an actuation mechanism according to a further embodiment of the present invention. The actuation mechanism includes a bowed actuatinglever40. Bowed actuatinglever40 may be resiliently biased in the bowed state illustrated inFIG. 3. The interior ofhandle body15″′ inFIG. 3 includes aslide block member42 attached to the proximal portion of bowed actuatinglever40.Slide block member42 is connected to the proximal end of the elongated member extending from unit12 (not shown) similar to driveblock30 ofFIGS. 1A-1B.
• Theslide block42 is guided through movement byguide bars44 in the interior of thehandle body15. Because the force imparted to slideblock42 upon actuation of the bowed actuatinglever40 is directed both linearly and longitudinally, guide bars44 formed on opposing sides of theslide block42 guide the slide block through longitudinal motion. Theslide block member42 may be attached directly to the bowed actuatinglever40 or connected by ahinge spring22″′. Theslide block member42 may alternatively be attached to the proximal end ofsheath14 for movement between expanded and collapsed states of theend effector unit12, as explained above. The dashedlines45 at the proximal end of thehandle15″′ ofFIG. 3 represent the position ofslide block42 upon actuation of bowed actuatinglever40.
• FIGS. 4A-4B illustrate the actuation of any of the previously described handles by an operator. For purposes of the present specification and claims, the term “finger” is intended to include in its scope each of the five digits of the hand, including the thumb. As seen inFIGS. 4A-4B, the operator may insert a finger infinger ring16 to add stability and control for the operator as the handle is gripped. Thefinger ring16 is disposed on an exterior surface of the handle body and positioned approximately 90° relative to theactuation lever18. This design allows an operator to grip thehandle10 by inserting a finger into thefinger ring16 and leaving the remaining fingers of the handle comfortably positioned for actuation of theactuation lever18. This design also allows an operator to simultaneously grasp the sheath14 (as seen inFIG. 4A-4B) of the device between two or more fingers for forward advancement of the sheath toward a treatment site.
• InFIG. 4A, the actuation mechanism is shown in the rest position with the actuatinglever18 disposed under the operator's middle, ring, and end fingers. The operator's index finger and thumb may be used to holdsheath14 for movement relative to a scope, for example through a scope channel. InFIG. 4B, the actuation mechanism is closed with the actuatinglever18 moved toward a direction essentially normal to the main longitudinal axis of thehandle10 andsheath14. As represented inFIGS. 4A-4B, the configuration ofhandle10 within an operator's grip as well as the direction of actuation allow an operator to grip andadvance sheath14 with the same hand that performs the actuation ofunit12.
• FIG. 5 Illustrates a further embodiment of a medical device including ahandle10, asheath14, and anend effector unit12 according to any of the embodiments described above. The medical device ofFIG. 5 further includes a proximal adapter hub47 connected to handle10, adistal adapter hub48, and anadapter shaft50, which receives thesheath14 and the elongate member. The elongate member is connected to and extends proximally fromunit12. The medical device also includes anadapter spring52 providing resistance to movement between the handle10 (connected proximal adapter hub47) anddistal adapter hub48.
• The device ofFIG. 5 may access a surgical site through an auxiliary access channel of an endoscope. The distal portion ofsheath14 andend effector unit12 may be inserted through a medical viewing instrument, such as an ureteroscope for viewing a surgical site during urologic surgery. The sheath andend effector unit12 may be received within an access channel of an endoscope such that the distal end of the sheath14 (and end effector unit12) extends beyond the distal end of the endoscope. Therefore, actuation of theend effector unit12 can be viewed through the endoscope during a treatment procedure. The distal end of thedistal adapter hub48 may connect to the proximal end of an auxiliary access channel of an endoscope. This connection can take place, for example, by means of a conventional luer fitting formed at the distal end ofhub48.
• Upon insertion through an access channel of an endoscope, the medical device ofFIG. 5 can be moved relative to the endoscope against the force ofadapter spring52. Thesheath14 may correspond in length to the length of the ureteroscope such that the distal ends of the two devices will be substantially aligned during use. When both medical devices are joined viadistal adapter hub48,sheath14 andend effector unit12 can be advanced relative to thedistal adapter hub48, and therefore relative to the ureteroscope. As thesheath14 andend effector unit12 are advanced by forward movement ofhandle10 with respect todistal adapter hub48, theadapter spring52 provides tactile feedback resistance to the operator for better control of relative movement between the devices.
• Theend effector unit12 ofFIG. 5 is actuated by the use of afinger trigger53 which engages aninternal gear57 in order to impart motion to aproximal drive55.Proximal drive55 can be connected to either the elongated member connected to theend effector unit12 or to a proximal end ofsheath14. In either case, the actuation offinger trigger53 imparts motion to theproximal drive55 thereby actuating theend effector unit12. The dashed lines at the right hand side ofFIG. 5, represent the actuated position ofproximal drive55.
• FIG. 6 illustrates an additional embodiment of the present invention directed to a medical device handle60 for the relative movement of multiple medical devices.Handle60, as shown inFIG. 6, houses multiple medical devices, such as adevice61 for manipulating material within a patient's body as described above, in addition to a device for breaking up material, such as alithotriptor62. During urological medical procedures,device61 having an end effector unit for manipulating material will be positioned to grasp material to be removed from a surgical treatment site. Often, material grasped, such as a kidney stone, is too large to be removed from the site without breaking down the material first. Alithotriptor62, which can include a laser fiber for directing energy and breaking down the subject material, is concurrently introduced with the end effector instrument, which may also be used as a backstop during lithotripsy. Proper alignment and relative movement of the devices is necessary for the safe and efficient breakdown and removal of the unwanted material.
• As seen inFIG. 6, medical device handle60 includes a moldedfinger grip64 for enhanced handling, afinger slide66, andside recess ports68 and70.FIG. 7 is a side cross-sectional view ofhandle60.Handle60 may include at least twoside recess ports68 and70, each configured to receive an elongated medical device shaft therein. As seen inFIG. 8,side recess ports68 and70 are externally accessible for enhanced insertion and removal of medical devices therein.
• Afirst recess port68 may receive alithotriptor62 for engagement with a movableinternal grip72.Internal grip72 may be rubber, polymer, or any other suitable material sized to, for example, receivelithotriptor62 through a friction fit.Internal grip72 engages multiple sides oflithotriptor62 received therein.Internal grip72 is integrally formed withfinger slide64, which extends to the exterior of thehandle60. Longitudinal movement of thefinger slide64 will move thelithotriptor62 relative to thedevice handle60.FIG. 7 also illustrates aspring74 disposed inport68 between theinternal grip72 and a forward end of thehandle60. The resistance provided byspring72 provides tactile feedback to the operator for enhanced control of longitudinal movement of the device inrecess port68.
• Asecond recess port70 may receive adevice61 for manipulating material within a patient's body for engagement with at least one stationaryinternal grip76.Grip76 may be rubber, polymer or any other suitable material sized to, for example, receivedevice61 through a friction fit.Grip76 may be manufactured integral with the body ofhandle60. As shown inFIG. 7,second recess port70 may include multiple stationaryinternal grips76. Stationaryinternal grip members76 prevent any relative longitudinal movement betweenhandle60 and any medical device received therein.FIG. 7 illustrates thatmedical devices61 and62 may be inserted into an auxiliary access channel of aureteroscope78. Accordingly, handle60 allows for movement of bothdevices61 and62 relative to the viewing area observed byureteroscope78. In addition, movement offinger slide66 allows for relative movement between the devices housed withinrecess ports68 and70.
• Analternative handle configuration80 is illustrated inFIG. 9.Handle configuration80 is similar to handle60 ofFIGS. 6-8, except that handle80 includes an actuation mechanism including atrigger82. As described above with reference to the embodiments ofFIGS. 1A-5, handle80 may include an actuation mechanism for anend effector unit12 corresponding to a medical device associated with one of the recess ports.Handle80 allows for relative movement between the medical devices (such as alithotriptor62 and a retrieval device61) as well as actuation of a device (such asunit12 of retrieval device61) through the same handle. Any of the handle configurations described above may be substituted and incorporated within the alternative configuration ofFIG. 9.
• As mentioned above, during some medical procedures, an endoscope is used to provide an operator with access for a medical device (through an internal lumen or working channel of the endoscope) and a view of the internal treatment site. The endoscope is often repositioned to access different treatment sites, to obtain proper placement for performing an operation at a treatment of the site (for example, by providing irrigation through a working channel of the endoscope), or in order to maintain a clear view of a desired treatment site beyond the distal end of the endoscope. In procedures where a retrieval device or a laser fiber is concurrently positioned with an endoscope, the operator must manipulate the endoscope with one hand and position the additional device with the other hand.
• FIG. 10 illustrates an additional embodiment of the present invention directed to a medical device handle90 adapted for releasable engagement with an endoscope (not shown) for access to an internal lumen of the endoscope. Handle90 ofFIG. 10 includes a medical device including asheath14 and anend effector unit12. As in the embodiments disclosed above,sheath14 may be flexible and includes an internal lumen for receiving theend effector unit12. As in the previous embodiments, theend effector unit12 andsheath14 are movable relative to each other in order to achieve a first collapsed state of theend effector unit12 in which theend effector unit12 is collapsed within the lumen of the distal end of thesheath14 and a second state in which theend effector unit12 extends from the distal end of thesheath14 and expands (seen inFIG. 12).End effector unit12 may comprise a basket, grasper, snare, any other retrieval or grasping mechanism, or any other mechanism for performing an operation in a body and may be suitable for urological, endoscopic, or other like procedures.End effector unit12 is illustrated inFIGS. 10 and 12 as a basket having a plurality of legs.
• FIG. 10 shows two states of the medical device (sheath14 and unit12). The device has a first state (represented by letter “A”) in which the device is not inserted into a port of thehandle90. This first state may represent a position of the device when it is packaged and subsequently opened for use. The device has a second state (represented by letter “B”) in which the device is inserted into a port ofhandle90 and is ready for use.
• Similar to the previous embodiments, theend effector unit12 extends distally from an elongated member disposed within the lumen ofsheath14. The elongated member extends proximally from theend effector unit12 into the body ofhandle90 and may be in the form of a flexible shaft, coil, cable, or wire. In the embodiment illustrated inFIGS. 10-12, the proximal end of the elongated member is connected to a movable internal portion of thehandle90, such that movement of the movable internal portion will move theend effector unit12 relative tosheath14 between expanded and collapsed states. Alternatively, the proximal end of thesheath14 may be connected to a movable internal portion of thehandle90 such that movement of the movable internal portion will extend thesheath14 over theend effector unit12 and thereby collapse theend effector unit12.
• Referring toFIG. 10, handle90 includes anactuator92, anactuator housing94, aconnector96 for engagement with an endoscope, anozzle98, and first andsecond device ports100 and102 respectively. Astrain relief portion104 is positioned to provide support between theactuator housing94 and a proximal end of thesheath14. As seen inFIG. 10,sheath14 extends from theactuator housing94 such that the distal end of thesheath14 can be redirected and inserted along the longitudinal axis of and into thefirst device port100. Thefirst device port100 includes an internal lumen that extends through the body ofhandle90 and continues throughnozzle98. The internal lumen of thefirst device port100 is adapted to receive the distal end of thesheath14 and guide thesheath14 through the lumen to a point where it exits distally from the body ofhandle90 at a distal end ofnozzle98. In addition,second device port102 may include an internal lumen that extends through the body ofhandle90 and terminates at the distal end ofnozzle98.
• In operation, handle90 may be releasably operatively engaged with an endoscope in order to enable access with an internal lumen of the endoscope, for example, an auxiliary access channel of an endoscope. The engagement may be achieved by linkingconnector96 to the proximal end of an auxiliary access channel (or any internal working lumen of an endoscope) through a threaded engagement, a snap fit connection, a male/female connection, a press fit engagement, or by similar alternative connections. Upon engagement,sheath14 may access an internal lumen of the endoscope through insertion into thefirst device port100 orsecond device port102 and beyond the distal end ofnozzle98. Also upon engagement, the first andsecond device ports100 and102 extend along an axis substantially parallel to the longitudinal axis of the endoscope.
• The configuration ofhandle90 and itsactuator92 permits a single user to operate as endoscope with one hand and activate the medical device inhandle90 with the other hand in a natural, comfortable position of the user's hands and arms. For example, operation of an endoscope is often preformed by grasping the proximal end of the scope with one hand such that the longitudinal axis of the scope runs relatively perpendicular to the length of the operator's forearm. Because thedevice ports100 and102 extend along an axis substantially parallel to that of the endoscope, handle90 can be gripped with the other hand in a manner substantially similar to that used to manipulate the endoscope. In addition, due to the positioning and configuration of both actuatorhousing94 and theactuator92, for example extending substantially perpendicular to the longitudinal axis of the first andsecond device ports100 and102, Actuation of actuator92 (as described below) is accomplished by a natural movement of the operator's hand. In this configuration, actuation of theactuator92 is not unlike the movement performed by a musician to depress the valve of a trumpet.
• FIGS. 11A and 11B illustrate partial side cross-sectional views of the actuation mechanism ofhandle90. The actuation mechanism includes anactuator housing94, anactuator92, acompression spring106, and aninternal cannula108.Housing94 includes a top95 defining ahole97.Housing94 further defines aninternal cavity99 defined by the walls ofhousing94. Theactuator92 may include, for example, aplunger112 having anactuation platform114 and abase116.Plunge92 is received within and movable relative to hole97.Base116 may be connected to theinternal cannula108 which receives the proximal end of theelongate member110. Theelongate member110, in turn, is fastened to thebase116 ofplunger112 such that actuation of theplunger112 displacesinternal cannula108 andelongated member110.Sheath14 is fixedly attached to a distal end ofhandle90, for example to strainrelief104.
• As seen inFIG. 11A, thecompression spring106 contacts base116 in order to bias theplunger112 toward an extended non-actuated position. Upon actuation of theplunger112 against the biasing force ofcompression spring106,base116,internal cannula108, andelongated member110 are all displaced relative tosheath14, as seen inFIG. 11B. As noted above, because theend effector unit12 extends distally from theelongated member110, actuation ofplunger112 will move theend effector unit12 relative tosheath14 between collapsed and expanded states. The resistance provided bycompression spring106 provides tactile feedback to the operator for better control of the end effector expansion.
• Referring toFIG. 12, actuation ofplunger112 is depicted. During a medical procedure, handle90 may be operatively engaged with an auxiliary access channel of an endoscope in order to facilitate manipulation of both the endoscope and theend effector unit12 by an operator. In use, the distal end ofsheath14 can be advanced through and beyond the access channel of an endoscope and positioned relative to the distal end of an endoscope for viewing at a desired treatment site. Once the distal end ofsheath14 is properly positioned at a treatment site within an anatomical lumen of a patient, the same operator of the endoscopic viewing device may deploy theend effector unit12 as desired upon actuation of theplunger112.
• In addition, a lithotriptor, as described above with reference toFIG. 6, or other desired medical device, may be introduced through thesecond device port102 ofhandle90 whilesheath14 andunit12 are used throughfirst device port100. Accordingly, an operator may control the relative movement between theend effector unit12 and the distal end of a lithotriptor relative to the viewing area observed by an endoscope at a treatment site. Furthermore, the engagement betweenhandle90 and the endoscope positions the actuation portions of all three devices (i.e. a retrieval device, a lithotriptor, and an endoscope) in close proximity to a single operator thereby reducing the need for an assistant during medical procedures.
• Though shown with a retrieval device (and particularly a basket) and a lithotriptor device, the handles described above can be used with any other medical devices which require actuation or longitudinal positioning of medical devices at a treatment site. The reference to the use of a retrieval device and lithotriptor are used as examples and are not intended to limit the scope of the invention.
• Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only, with a true scope and spirit of the invention being indicated by the following claims.

Claims (2)

1. A medical device, comprising:

a sheath including a lumen, a distal end, and a proximal end;

an end effector unit and an elongate member connected to the end effector unit and extending proximally from the end effector unit within the lumen of the sheath, the end effector unit and sheath movable relative to each other to achieve a first state of the end effector unit when the end effector unit is within the lumen of the sheath and a second state of the end effector unit when the end effector unit extends from the distal end of the sheath; and

a handle connected to the proximal end of the sheath and a proximal end of the elongate member, the handle comprising an actuator to selectively actuate the end effector unit between the first and second states,

wherein the handle is configured to allow a single hand of an operator to simultaneously be positioned to actuate the end effector unit via the actuator and grasp and manipulate the sheath.

2-54. (canceled)

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