RELATED APPLICATIONPriority for this application is hereby claimed under 35 U.S.C. §119(e) to commonly owned and co-pending U.S. Provisional Patent Application No. 60/830,035 which was filed on Jul. 11, 2006. The content of all of the aforementioned application is hereby incorporated by reference herein in its entirety.
TECHNICAL FIELDThe present invention relates in general to surgical instruments, and more particularly to manually-operated surgical instruments that are intended for use in minimally invasive surgery or other forms of surgical or medical procedures or techniques. The instrument described herein is primarily for a laparoscopic procedure, however, it is to be understood that the instrument of the present invention can be used for a wide variety of other procedures, including intraluminal procedures.
BACKGROUND OF THE INVENTIONEndoscopic and laparoscopic instruments currently available in the market are extremely difficult to learn to operate and use, mainly due to a lack of dexterity in their use. For instance, when using a typical laparoscopic instrument during surgery, the orientation of the tool of the instrument is solely dictated by the locations of the target and the incision. These instruments generally function with a fulcrum effect using the patients own incision area as the fulcrum. As a result, common tasks such as suturing, knotting and fine dissection have become challenging to master. Various laparoscopic instruments have been developed over the years to overcome this deficiency, usually by providing an extra articulation often controlled by a separately disposed control member for added control. However, even so these instruments still do not provide enough dexterity to allow the surgeon to perform common tasks such as suturing, particularly at any arbitrarily selected orientation. Also, existing instruments of this type do not provide an effective way to hold the instrument in a particular position. Moreover, existing instruments require the use of both hands in order to effectively control the instrument.
Accordingly, an object of the present invention is to provide an improved laparoscopic or endoscopic surgical instrument that allows the surgeon to manipulate the tool end of the surgical instrument with greater dexterity.
Another object of the present invention is to provide an improved surgical or medical instrument that has a wide variety of applications, through incisions, through natural body orifices or intraluminally.
A further object of the present invention is to provide an improved medical instrument that is characterized by the ability to lock the instrument in a pre-selected particular position.
Another object of the present invention is to provide a locking feature that is an important adjunct to the other controls of the instrument enabling the surgeon to lock the instrument once in the desired position. This makes it easier for the surgeon to thereafter perform surgical procedures without having to, at the same time, hold the instrument in a particular bent configuration.
Still another object of the present invention is to provide an improved medical instrument that can be effectively controlled with a single hand of the user.
Still a further object of the present invention is to provide an improved medical instrument in which both locking and rotation features of the instrument are controlled from a single control element.
SUMMARY OF THE INVENTIONTo accomplish the foregoing and other objects, features and advantages of the present invention there is provided a surgical instrument that includes an instrument shaft having proximal and distal ends; a tool disposed from the distal end of the instrument shaft; a control handle disposed from the proximal end of the instrument shaft; a distal motion member for coupling the distal end of said instrument shaft to said tool; a proximal motion member for coupling the proximal end of said instrument shaft to said handle; actuation means extending between said distal and proximal motion members for coupling motion of said proximal motion member to said distal motion member for controlling the positioning of said tool; a rotation knob disposed adjacent the control handle and rotatable relative to the control handle for causing a corresponding rotation of the instrument shaft and tool; and a locking mechanism for fixing the position of the tool at a selected position and having locked and unlocked states. The rotation knob has a first position in which the locking mechanism is controlled to be in its locked state and a second position in which the locking mechanism is released to its unlocked state so as to allow tool positioning.
In accordance with other aspects of the present invention at least the proximal motion member comprises a proximal bendable member and the rotation knob is adapted to rotate the tool about a distal tool roll axis; the control handle comprises a pistol grip handle having an engagement horn to assist in holding the handle; the rotation knob is disposed at the distal end of the handle and the horn is disposed proximally of the rotation knob and on the top of the pistol grip handle; including an actuation lever supported from the pistol grip handle at a pivot point at the proximal end of the handle; the actuation lever has a free end with a finger loop for receiving a users finger to control the lever; further including a release button on the handle in juxtaposition to the lever and for releasing the lever from an actuated to released position; the rotation knob is supported relative to the handle so as to rotate about a rotation knob axis, and wherein the rotation knob is moved axially from the first to second positions; the rotation knob is moved toward the handle to activate the locking mechanism and is moved away from the handle to release the locking mechanism; including a tool actuation cable that extends from the tool to the handle, a slider for capturing the proximal end of said tool actuation cable and an actuation lever supported at the handle for controlling the translation of the slider; including a slideway for receiving the slider, a pair of springs disposed in the slider and a rotational barrel disposed between the springs and for holding the proximal end of the tool actuation cable; the locking mechanism comprises a follower mechanism disposed proximally of the rotation knob, the proximal motion member comprising a proximal bendable member and a plurality of locking cables that intercouple between the follower mechanism and the proximal bendable member; the locking mechanism further comprises an expandable sphere for supporting the locking cables and a plunger engaging with a center passage of the expandable sphere, the plunger supported from the rotation knob.
In accordance with another embodiment of the present invention there is provided a surgical instrument comprising: an instrument shaft having proximal and distal ends; a tool disposed from the distal end of the instrument shaft; a control handle disposed from the proximal end of the instrument shaft; a distal motion member for coupling the distal end of the instrument shaft to the tool; a proximal motion member for coupling the proximal end of the instrument shaft to the handle; actuation means extending between the distal and proximal motion members for coupling motion of the proximal motion member to the distal motion member for controlling the positioning of the tool; said control handle including a pistol grip handle; and an actuation lever for controlling the tool and pivotally supported from the handle; said actuation lever having a free end with a recess for receiving a finger of the user to control the actuation lever.
In accordance with other aspects of the present invention the surgical instrument includes a ball supported in a socket at the free end of the actuation lever, said ball having a hole therein that defines the finger recess; the ball is freely rotatable in the socket and the hole is a through hole; the ball is freely rotatable in the socket and the hole is a blind hole; a release button on the handle is in juxtaposition to the lever and for releasing the lever from an actuated to released position; a rotation knob is disposed adjacent the control handle and rotatable relative to the control handle for causing a corresponding rotation of the instrument shaft and tool, and a locking mechanism for fixing the position of the tool at a selected position and having locked and unlocked states, said rotation knob having a first position in which the locking mechanism is controlled to be in its locked state and a second position in which the locking mechanism is released to its unlocked state so as to allow tool positioning; the rotation knob is supported relative to the handle so as to rotate about a rotation knob axis, and wherein the rotation knob is moved axially from the first to second positions; an engagement horn to assist in holding the handle and wherein the rotation knob is disposed at the distal end of the handle and the horn is disposed proximally of the rotation knob and on the top of the pistol grip handle.
In accordance with still another embodiment there is provided a medical instrument having a proximal control handle and a distal tool that are intercoupled by an elongated instrument shaft that is meant to pass internally of an anatomic body, proximal and distal movable members that respectively intercouple the proximal control handle and the distal tool with the instrument shaft, cable actuation means disposed between the movable members, said control handle having proximal and distal ends, an actuation lever for controlling the distal tool, means for pivotally supporting the actuation lever from the proximal end of the handle at one side thereof, a horn and means for fixedly supporting the horn from the distal end of the handle at an opposite side thereof.
In accordance with still other aspects of the present invention the medical instrument includes a locking means that is manually operable by a user and that includes a follower the position of which is responsive to the position of the movable members; a rotation knob is disposed adjacent the control handle and rotatable relative to the control handle for causing a corresponding rotation of the instrument shaft and tool, and a locking mechanism for fixing the position of the tool at a selected position and having locked and unlocked states, said rotation knob having a first position in which the locking mechanism is controlled to be in its locked state and a second position in which the locking mechanism is released to its unlocked state so as to allow tool positioning; the rotation knob is supported relative to the handle so as to rotate about a rotation knob axis, and wherein the rotation knob is moved axially from the first to second positions; the control handle includes a pistol grip handle and the actuation lever has a free end with a recess for receiving a finger of the user to control the actuation lever; a ball is supported in a socket at the free end of the actuation lever, said ball having a hole therein that defines the finger recess; including a rotation control member at the distal end of the handle, said horn disposed adjacent to the rotation control member, said actuation lever supported for movement toward and away from the handle; including a release button on the handle in juxtaposition to the lever and for releasing the lever from an actuated to released position; including a slider in the handle for controlling a tool actuation cable, said lever including a pivot point attached to the handle and disposed between one end that defines a socket for a rotation gimbal for accommodating the user's finger and another end that engages the slider.
BRIEF DESCRIPTION OF THE DRAWINGSIt should be understood that the drawings are provided for the purpose of illustration only and are not intended to define the limits of the disclosure. The foregoing and other objects and advantages of the embodiments described herein will become apparent with reference to the following detailed description when taken in conjunction with the accompanying drawings in which:
FIG. 1 is a perspective view of a first embodiment of the surgical instrument of the present invention illustrating it being grasped by a surgeon;
FIG. 2 is a cross-sectional side view of a second embodiment of the instrument of the present invention with the instrument in its rest position and illustrating in phantom the surgeon's fingers;
FIG. 2A is a cross-sectional view of an alternate embodiment of the finger gimbal;
FIG. 3 is an enlarged cross-sectional side view of the instrument shown inFIG. 2 showing the end effector bent at an angle B2 in response to the handle being bent at an angle B1, and with the end effector in a closed position grasping an item;
FIGS. 4A-4C are illustrative cross-sectional side views at the distal end of the medical instrument, and with the movable jaw in different respective positions;
FIG. 4D is a cross-sectional view taken alongline4D-4D ofFIG. 4C;
FIG. 5 is a cross-sectional plan view of the handle portion of the instrument of the second embodiment as taken along line5-5 ofFIG. 2;
FIG. 6 is a cross-sectional end view taken along line6-6 ofFIG. 5;
FIG. 7 is a cross-sectional end view taken along line7-7 ofFIG. 5;
FIG. 8 is a cross-sectional end view taken along line8-8 ofFIG. 5;
FIG. 9 is a cross-sectional end view taken along line9-9 ofFIG. 5;
FIG. 10 is a cross-sectional end view taken along line10-10 ofFIG. 5;
FIG. 11 is a cross-sectional end view taken along line11-11 ofFIG. 5;
FIG. 12 is a cross-sectional end view taken along line12-12 ofFIG. 5;
FIG. 13 is a fragmentary enlarged cross-sectional plan view taken along line13-13 ofFIG. 5 showing the proximal bendable member and angled locking mechanism at rest;
FIG. 14 is a cross-sectional view similar to that shown inFIG. 13, but with the proximal bendable member locked in an angled relationship to the handle;
FIG. 15 is an exploded perspective view at the proximal bendable member and rotation knob, and illustrating further details of the angle locking member ofFIG. 13; and
FIG. 16 is a fragmentary perspective view of the assembled proximal bendable member, rotation knob and locking mechanism ofFIG. 15, but showing the proximal bendable member locked in a bent position relative to the instrument handle.
DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTThe instrument of the present invention may be used to perform minimally invasive procedures. “Minimally invasive procedure,” refers herein to a surgical procedure in which a surgeon operates through small cut or incision, the small incision being used to access the operative site. In one embodiment, the incision length ranges from 1 mm to 20 mm in diameter, preferably from 5 mm to 10 mm in diameter. This procedure contrasts those procedures requiring a large cut to access the operative site. Thus, the flexible instrument is preferably used for insertion through such small incisions and/or through a natural body lumen or cavity, so as to locate the instrument at an internal target site for a particular surgical or medical procedure. The introduction of the surgical instrument into the anatomy may also be by percutaneous or surgical access to a lumen or vessel, or by introduction through a natural orifice in the anatomy.
In addition to use in a laparoscopic procedure, the instrument of the present invention may be used in a variety of other medical or surgical procedures including, but not limited to, colonoscopic, upper GI, arthroscopic, sinus, thorasic, prostate, transvaginal and cardiac procedures. Depending upon the particular procedure, the instrument shaft may be rigid, semi-rigid or flexible.
Although reference is made herein to a “surgical instrument,” it is contemplated that the principles of this invention also apply to other medical instruments, not necessarily for surgery, and including, but not limited to, such other implements as catheters, as well as diagnostic and therapeutic instruments and implements.
FIG. 1 is a perspective view of one embodiment of thesurgical instrument10 of the present invention. In this surgical instrument both the tool and handle motion members or bendable members are capable of bending in any direction. They are interconnected via cables in such a way that a bending action at the proximal member provides a related bending at the distal member. The proximal bending is controlled by a motion or deflection of the control handle by a user of the instrument. In other words the surgeon grasps the handle and once the instrument is in position any motion at the handle (deflection) immediately controls the proximal bendable member which, in turn, via cabling controls a corresponding bending or deflection at the distal bendable member. This action, in turn, controls the positioning of the distal tool.
The proximal member is preferably generally larger than the distal member so as to provide enhanced ergonomic control. In one version in accordance with the invention there may be provided a bending action in which the distal bendable member bends in the same direction as the proximal bendable member. In an alternate embodiment the bendable, turnable or flexible members may be arranged to bend in opposite directions by rotating the actuation cables through 180 degrees, or could be controlled to bend in virtually any other direction depending upon the relationship between the distal and proximal support points for the cables.
It should be noted that the amount of bending motion produced at the distal bending member is determined by the dimension of the proximal bendable member in comparison to that of the distal bendable member. In the embodiment described the proximal bendable member is generally larger than the distal bendable member, and as a result, the magnitude of the motion produced at the distal bendable member is greater than the magnitude of the motion at the proximal bendable member. The proximal bendable member can be bent in any direction (about 360 degrees) controlling the distal bendable member to bend in either the same or an opposite direction, but in the same plane at the same time. Also, as depicted inFIG. 1, the surgeon is able to bend and roll the instrument's tool about its longitudinal axis at any orientation simply by rolling the axial rotation knob.
In this description reference is made to bendable members. These members may also be referred to as turnable members, bendable members or flexible members. In the descriptions set out herein, terms such as “bendable section,” “bendable segment,” “bendable motion member,” or “turnable member” refer to an element of the instrument that is controllably bendable in comparison to an element that is pivoted at a joint. The term “movable member” is considered as generic to bendable sections and joints. The bendable elements of the present invention enable the fabrication of an instrument that can bend in any direction without any singularity and that is further characterized by a ready capability to bend in any direction, all preferably with a single unitary or uni-body structure. A definition of a “unitary’ or “uni-body” structure is—a structure that is constructed only of a single integral member and not one that is formed of multiple assembled or mated components—.
A definition of these bendable motion members is—an instrument element, formed either as a controlling means or a controlled means, and that is capable of being constrained by tension or compression forces to deviate from a straight line to a curved configuration without any sharp breaks or angularity—. Bendable members may be in the form of unitary structures, such as shown herein inFIG. 2, may be constructed of engageable discs, or the like, may include bellows arrangements or may comprise a movable ring assembly. For other forms of bendable members refer to co-pending provisional application Ser. No. 60/802,885 filed on May 23, 2006 and 60/811,046 filed on Jun. 5, 2006, both of which are hereby incorporated by reference herein in their entirety.
FIG. 1 shows a first embodiment of the instrument of the present invention. A second preferred embodiment is illustrated inFIGS. 2-16.FIG. 1 depicts thesurgical instrument10 in position, as may occur during a surgical procedure. For example, the instrument may be used for laparoscopic surgery through the abdominal wall4. For this purpose there is provided aninsertion site6 at which there is disposed a cannula ortrocar8. Theshaft14 of theinstrument10 is adapted to pass through thecannula8 so as to dispose the distal end of the instrument at an operative site. Theend effector16 is depicted inFIG. 1 at such an operative site.FIG. 1 also depicts the rolling motion that can be carried out with the instrument of the present invention. This can occur by virtue of the rotation of therotation knob24 relative to thehandle12 about axis T (refer toFIG. 3). This is illustrated inFIG. 1 by the circular arrow R1. Also see inFIG. 1 the coordinate X-Y-Z system. The Z axis corresponds to the longitudinal axis of theinstrument shaft14. When therotation knob24 is rotated, in either direction, this causes a corresponding rotation of theinstrument shaft14. This is depicted inFIG. 1 by the rotational arrow R2. This same motion also causes a rotation of theend effector16 about axis P as illustrated by the rotational arrow R3.
Any rotation of therotation knob24 while the instrument is locked (or unlocked) maintains the instrument tip at the same angular position, but rotates the orientation of the tip (tool). For a further explanation of the rotational feature refer to co-pending application Ser. No. 11/302,654, filed on Dec. 14, 2005, particularly FIGS. 25-28, which is hereby incorporated by reference in its entirety.
InFIG. 3 thehandle12, via proximalbendable member18, is shown tilted along axis T at an angle B1 to the instrument shaft longitudinal center axis U. This tilting, deflecting or bending may be considered as in the plane of the paper. By means of the cabling this action causes a corresponding bend at the distalbendable member20 to a position wherein the tip is directed along axis P and at an angle B2 to the instrument shaft longitudinal center axis U. The bending at the proximalbendable member18 is controlled by the surgeon from thehandle12 by manipulating the handle in essentially any direction including in and out of the plane of the paper inFIG. 3. This manipulation directly controls the bending at the proximal bendable member.
Thus, the control at the handle is used to bend the instrument at the proximal motion member to, in turn, control the positioning of the distal motion member and tool. The “position” of the tool is determined primarily by this bending or motion action and may be considered as the coordinate location at the distal end of the distal motion member. Actually, one may consider a coordinate axis at both the proximal and distal motion members as well as at the instrument tip. This positioning is in three dimensions. The “orientation” of the tool, on the other hand, relates to the rotational positioning of the tool about the illustrated distal tip axis (see axis P inFIG. 3).
In the drawings a set of jaws is depicted, however, other tools or devices may be readily adapted for use with the instrument of the present invention. These include, but are not limited to, cameras, detectors, optics, scope, fluid delivery devices, syringes, etc. The tool may include a variety of articulated tools such as: jaws, scissors, graspers, needle holders, micro dissectors, staple appliers, tackers, suction irrigation tools and clip appliers. In addition, the tool may include a non-articulated tool such as: a cutting blade, probe, irrigator, catheter or suction orifice.
The surgical instrument ofFIG. 1 shows a first embodiment of asurgical instrument10 according to the invention in use and inserted through acannula8 at aninsertion site6 through a patient's skin. Many of the components shown in both embodiments described herein, such as theinstrument shaft14,end effector16, distal bendingmember20, and proximal bendingmember18 may be similar to and interact in the same manner as the instrument components described in the co-pending U.S. application Ser. No. 11/185,911 filed on Jul. 20, 2005 and hereby incorporated by reference herein in its entirety. Also incorporated by reference in their entirety are U.S. application Ser. No. 10/822,081 filed on Apr. 12, 2004; U.S. application Ser. No. 11/242,642 filed on Oct. 3, 2005 and U.S. application Ser. No. 11/302,654 filed on Dec. 14, 2005, all commonly owned by the present assignee.
The first embodiment of the instrument shown inFIG. 1 is typically used with asheath98 to keep bodily fluids from entering thedistal bending member20. Therotation knob24, proximal bendingmember18 andadapter26 accommodate preferably four bend control cables, as well as four lock control cables which are connected to a novel angle locking means orfollower140 which is supported adjacent the proximal end of therotation knob24, as depicted inFIG. 2. The locking means interacts with a portion of the proximalbendable member18 to lock and unlock the positioning of the bend control cables which in turn control the angle of the proximal bending member and thus the angle of the distal bendable member and end effector. This lock control allows the surgeon one less degree of control to concentrate on when performing certain tasks. By locking the bendable sections at a particular position, this enables the surgeon to be more hands-free for controlling other degrees of freedom of the instrument such as manipulation of therotation knob24 and, in turn, orientation of the end effector.
The instruments shown in respectiveFIGS. 1 and 2 are primarily of the same construction with the exception that the control lever for tool actuation is somewhat different in the two embodiments. In both of these embodiments the handle is of a pistol grip type. InFIG. 1 thelever22 has multiple indentations for one or more fingers and a release button on the handle disposed in facing relationship to the lever. In the embodiment ofFIG. 2 thelever22′ has a single finger hole for controlling the lever and also includes a similar release button. The release button is used to release the actuated or closed tool and is identified in both of the disclosed embodiments asbutton96.
In the first embodiment, the instrument is illustrated with the handle end of the instrument tipped downwardly in the direction of arrow V. This movement bends the instrument at the proximalbendable member18, as can be seen inFIG. 1. This action, in turn, bends the distal bendable member upwardly as also shown inFIG. 1. As mentioned before, opposite direction bending can be used by rotating or twisting the control cables through 180 degrees.
One feature of the present invention is the ability for both locking and rotating the instrument, controlled from a single control element, preferably controlled at therotation knob24. In a preferred embodiment of the present invention the angle locking means140 is engaged by axially displacing the rotation knob, such as by pulling on therotation knob24 in a proximal direction into the handle. The locking feature can be released or disengaged by pushing on theknob24 in a distal direction as described in further detail hereinafter.
In both embodiments described herein, thehandle12 is in the form of a pistol grip and includes ahorn13 to facilitate a comfortable interface between the action of the surgeon's hand and the instrument.FIG. 1 shows the hand position relative to the instrument handle. Ajaw clamping lever22 is shown inFIG. 1 pivotally attached at the base of the handle. Thelever22 actuates a slider (not shown inFIG. 1 but shown inFIG. 2) that controls a tool actuation cable that extends from the slider to the distal end of the instrument.FIG. 1 also shows ajaw release button96 that is located on the inside of thehandle12 just above the pivot for thejaw clamping lever22. As will be described in more detail hereinafter, thebutton96 engages the slider in a ratcheting action until released by pushing on it as indicated by the arrow M shown inFIG. 3.
The shape of the handle allows for a comfortable substantially one-handed operation of the instrument as shown in eitherFIG. 1 orFIG. 2. As shown inFIG. 1, the surgeon may grip thehandle12 between his palm and middle finger with thehorn13 nestled in the crook between his thumb and forefinger. This frees up the forefinger and thumb to rotate therotation knob24 using thefinger indentions31 that are disposed on the peripheral surface of the rotation knob. This arrangement also makes it possible to be able to push and pull on therotation knob24 to engage or disengage the angle locking means.FIG. 13 shows the rotation knob in its released position with it in its more distal position separated from the handle.FIG. 14 shows the rotation knob in its locked position having been moved proximally toward the handle. In both locked and unlocked positions the rotation knob is capable of controlled rotation to control axial rotation at the tip of the instrument about axis P.
Thejaw clamping lever22 may be engaged by the ring and/or pinky fingers of the surgeon and has at least two indents to accommodate these fingers as shown inFIG. 1. When the surgeon wishes to release the clamped jaws, those two fingers are removed from thelever22 and one or both of them can then be used to depress thejaw release button96. Areturn spring82 in the handle (FIG. 2) opens the jaws and returns thelever22 to its relaxed position upon activating therelease button96.
A second preferred embodiment of the instrument is shown inFIG. 2. Further details of this instrument are shown inFIGS. 3-16. In this embodiment an alternatejaw clamping lever22′ is shown. In this version there is provided a fingertip engaging recess in agimbaled ball27 instead of two finger indentions. The free end of thelever22′ supports thegimbaled ball27 which has a through hole orrecess23 which receives one of the fingers of the user. Theball27 is free to at least partially rotate in the lever end. The surgeon may grip the handle between the palm, ring and pinky fingers with thehorn13 nestled in the crook between his thumb and forefinger and operate therotation knob24 as previously described. The surgeon may then operate thejaw clamping lever22′ with the forefinger or middle finger as shown in phantom outline inFIG. 2.
FIG. 2A illustrates an alternate preferred embodiment of the finger gimbal arrangement in a cross-sectional view. This is also in the form of a ball in a socket, in which the ball is free to be rotated in the socket, and in which the socket is defined in the lever free end. In this embodiment, rather than having the hole go completely through the ball there is provided ablind hole23′ in theball27′. The ball is free to rotate in the lever end and thus the ball can also be rotated to alternate positions corresponding to either a left-handed or right-handed user. The blind hole enables the user to have a firmer grip of the lever and thus enhanced control of the lever action.
In the first embodiment thelever22 can be controlled primarily by pressing inwardly on the lever. However, in the second embodiment as illustrated inFIG. 2, the surgeon can have greater control of thelever22′, as this arrangement allows the surgeon to push or pull the lever precisely rather than just a pull and release action. In the embodiment inFIG. 2 the surgeon can use the pinky or ring finger to squeeze thejaw release button96 to disengage the ratchet mechanism and thus release the tool. In another version of the invention thereturn spring82 may be eliminated in order that the jaws may be operated entirely under the control of, for example, the index or forefinger disposed in therecess23. This version of the invention is most advantageous when using an end effector such as scissors, whereas the embodiment shown inFIG. 1 would be best utilized with an end effector such as a needle driver or clamp.
Reference is now made toFIGS. 2-16 for further details of the second embodiment of the invention. In this embodiment thedistal bending member20 is shown without thesheath98 so as to provide the details of the distalbendable member20. The distal bendable member is shown as comprised of spaceddiscs110 that define therebetween the spacedslots112.Ribs111 connect betweenadjacent discs110 in a manner similar to that described in the afore-mentioned U.S. application Ser. No. 11/185,911.
As indicated previously, the end effector ortool16 is actuated by means of the jaw actuation means30 which is comprised primarily of theelongated lever22′. Thelever22′ is supported from the housing at thelever pivot pin72. Refer toFIGS. 2 and 3. The closing of thelever22′ against thehandle12 acts upon theslider28 which is used to capture the very proximal end of theactuation cable38. When theslider28 is in the position depicted inFIG. 2, it is noted that the end effector jaws are fully open. See alsoFIG. 4A. In that position theslider28 is disposed at the more distal end of theslideway84. Theslideway84 is part of the internal support in thehandle12. When theslider28 is moved proximally, as depicted inFIG. 3, then thejaws44 and46 are moved toward a closed position. InFIG. 3 the jaws are illustrated as closing so as to grasp aneedle45. See alsoFIG. 4B. In that position theslider28 has moved to the more proximal end of theslideway84.FIG. 3 shows the distal end of the slider spaced the dimension D1 from an end wall of theslideway84.FIG. 2, on the other hand, shows the slider contacting that same end wall.
Theinstrument shaft14 includes anouter shaft tube32 that may be constructed of a light weight metal material or may be a plastic material. The proximal end of thetube32 is received by theadaptor cover26. The distal end of thetube32 is secured to the distalbendable member20. Within theouter shaft tube32 there is provided asupport tube34 that is preferably constructed of a plastic material.Tube34 extends between the distal bendable orflexible member20 and the proximal bendable orflexible member18. Thejaw actuator cable38 extends within thissupport tube34. Thesupport tube34, as depicted inFIG. 3, supports along its length a plurality ofspacers36. There are preferably multiple spacers disposed along thesupport tube34. Each of thespacers36 is preferably evenly spaced and each may be provided with diametric guide slots (not shown). There may be four such guide slots disposed at 90 degree intervals about eachspacer36 for accommodating the respective cables.
Refer also now toFIGS. 4A-4D for further details of the tool end of the instrument. Theend effector16 is comprised of a pair ofjaws44 and46. As indicated previously these jaws may be used to grasp aneedle45 or other item. Theupper jaw44 fits within achannel47 in thelower jaw46. Apivot pin48 is used between the jaws to enable rotation therebetween. Atranslation pin42 extends through theslot50 ofjaw46 and theslot52 ofjaw44 and engages with the hole in the distalcable end connector40. Theconnector40 is secured to the very distal end of thejaw actuator cable38 and is positioned within a channel of thejaw44. When thelever22′ is in its rest position, as depicted inFIG. 2, the jaws are fully open. In that position thepin42 is at a more distal location maintaining the jaws in an open position. As thecable38 is pulled, such as proximally inFIG. 3, then thepin42 moves to the right in theslots50 and52 causing thejaws44 and46 to pivot toward a closed position.
FIGS. 4A-4D also depicts an end wall or plate54 of thejaw46. One end of the distalbendable member20 is urged against this end wall54. Themember20 may be secured to the wall54 by an appropriate means. In one embodiment, the cabling tension itself of the instrument holds the members together. On the end wall54 there are disposed a pair ofanchors56 and58 for theflex control cables100.FIG. 4D illustrates foursuch cables100. The distal end of the distalbendable member20 may be provided with pockets for receiving theanchors56 and58. Theanchors56 and58 are firmly attached to the end wall54.
Thejaw actuator cable38 terminates at its respective ends at the end effector and the rotation barrel66 (seeFIG. 3). Within each of the bendable sections orbendable members18 and20 there is provided a plastic tube. This includes adistal tube60 and aproximal tube62. Both of these tubes may be constructed of a plastic such as polyethyletherkeytone (PEEK). The material of thetubes60 and62 is sufficiently rigid to retain thecable38 and yet is flexible enough so that it can readily bend with the bending of thebendable members18 and20. The tubes have a sufficient strength to receive and guide the cable, yet are flexible enough so that they will not kink or distort, and thus keep the cable in a proper state for activation, and also defines a fixed length for the cable. Thetubes60 and62 are longitudinally stiff, but laterally flexible.
FIG. 4A depicts the jaws in a fully open position.FIG. 4B depicts the jaws grasping a needle.FIG. 4C depicts the jaws fully closed.FIG. 4D is a cross-sectional view taken alongline4D-4D ofFIG. 4C.
The proximalbendable member18 may also be constructed as a unitary or uni-body slotted structure including a series offlexible discs130 that definetherebetween slots132. A “unitary” or “uni-body” structure may be defined as one that is constructed for use in a single piece and does not require assembly of parts. Connectingribs131 may extend between adjacent discs. Clearance holes are provided in the discs and/or ribs for accommodating the fourbend control cables100. Theproximal bending member18 also has four additional passages for the lockingcables160 and a conicaldistal end portion19. Theconical portion19 is provided with four recesses163 (FIGS. 13 and 15) for cable anchors162 forcables160. Theconical portion19 also has fourguide grooves107 that match up with fourguide grooves106 in the adapter26 (FIG. 15) to channel the bendingcables100 to theouter shaft32. Therotation knob24 houses aninsert collar104 which in turn seats the proximal end of the proximal bending member.
Both of the bendable members preferably have a rib pattern in which the ribs (111,131) are disposed at a preferred 60 degree variance from one rib to an adjacent rib. This has been found to provide an improved bending action. It was found that by having the ribs disposed at intervals of less than 90 degrees therebetween improved bending was possible. The ribs may be disposed at intervals of from about 35 degrees to about 75 degrees from one rib to an adjacent one. By using an interval of less than 90 degrees the ribs are more evenly distributed. Refer toFIG. 7 for an illustration of ribs at 60 degrees to each other. As a result the bending motion is more uniform at any orientation. In the present invention both of the bendable members may be made of a highly elastic polymer such as PEBAX (Polyether Block Amide), but could also be made from other elastic and resilient materials.
Thehandle22′ inFIG. 2 is shown in the lowermost position which is considered as the “at rest” position. This would be achieved by either action of thereturn spring82 in thebore80 of theslide28 in certain instruments or by the surgeon manually moving the lever to that position in other embodiments of the instrument where a return spring is not desired.
FIG. 3 illustrates thelever22′ passing through aslot73 in the handle and being mounted to apivot pin72. Anarm70 of thelever22′ has acylindrical head71 which mates with arecess74 in aboss75 at the proximal end of theslider28. Theslider28 sits in theslideway84 and moves proximally and distally in response to the lever position and/or return spring action. Theslider28 carries arotatable barrel66 clamped to the push/pull cable38 by means of a set screws67. Thebarrel66 is rotatable in response to the rotation of the instrument shaft and end effector. Refer also toFIG. 5 for further details of the slider mechanism. Thebarrel66 sits in aslot68 which is open tocontiguous slot78 at one end and is closed by awall69 at its other end. Thewall69 has a through hole which acts as a guide for the push/pull cable38 that protrudes from the proximal end of thebarrel66, and thus guides the barrel action itself. Thebarrel66 is urged against thewall69 by acompression spring76 that is disposed in theslot78. The position of the lever, as depicted inFIGS. 2 and 5 has the jaws fully open as also shown inFIG. 4A.
As the lever is squeezed toward the handle, theslider28 is urged proximally against the pressure of thereturn spring82 which is a compression spring; that is if one is used. Thelever22′ is shown in three different positions inFIG. 3. The position ofFIG. 2 is shown inFIG. 3 by the lowermost phantom lines. The middle position, also shown in phantom lines, is approximately the position where theslider28 has traveled a distance D1 (inFIG. 3) and that themoveable jaw44 has contacted an item such as theneedle45. This is the position of theslider28 shown inFIG. 5 and with the jaws shown in the position inFIG. 4B grasping the item. From that position, further movement of theslider28 proximally results in thebarrel66 sliding distally relative to the slider, thus lifting off theend wall69 defined by theslot68. See the dimension D2 inFIG. 3. This action causes thespring76 to apply jaw clamping pressure on the needle, by further tensioning thecable38. When that position is reached, thebarrel66 andcable38 substantially cease linear movement but thelever22′ can be fully squeezed until the position shown in full line inFIG. 3 is reached. At that position, as depicted inFIG. 3, thestop29 on thelever22′ contacts thehandle12 and theslider28 stops just short of the end wall of theslideway84, imposing a maximum pressure on the needle.
A ratcheting action between therelease button96 and theslideway84 prevents theslider28 from any return motion until the release lever orbutton96 is pushed. Therelease button96 is mounted on apivot pin90 and has apawl94 that engages theteeth86 on underside of theslider28. Thepawl94 is urged into contact with the teeth on theslider28 by means of anintegral leaf spring92. The thickness t (FIG. 4B) of an item grasped by the jaws is adjusted for by the sliding action ofbarrel66. The distance D2 shown inFIG. 3 is determined by the thickness t or in other words is a direct function of the thickness t. This dimension also accommodates any proximal movement of thecable38 when theknob24 is pulled back to lock in the angle of the bendable members.
FIG. 3 shows the surgical tool grasping an item such as a needle and shows the end effector being bent at an angle B2 in response to the handle being bent at angle B1 to the instrument shaft. The resulting tilt of theuniversal ring142 of the angle locking means140 is also shown but thecables160 that control the tilt are not shown for simplicity as they lie in a plane behind thecables100 illustrated inFIG. 3. Thecables160 and their connections are shown in detail inFIGS. 13-16.
Theproximal bending member18 hasdiscs130,slots132 and connectingribs131 similar to the previous instrument but has four additional passages forrespective cables160 and a conicaldistal end portion19 with fourrecesses163 for cable anchors forcables160. The conical portion has fourelongated guide grooves107 that match up with four likeguide grooves106 in theadapter26. These matching grooves form a channel for capturing the bendingcables100 as they extend from the proximal bendable member into theouter shaft32.
Therotation knob24 houses aninsert collar104 which in turn seats the proximal end of the proximal bendingmember18. Therotation knob24 andcollar104 have mating features for engagement therebetween so that they rotate together. Therotation knob24 has diametrically disposed internally facingridges25 which engage matchingmating channels105 ininsert collar104, as most clearly shown inFIG. 15. During assembly, thecables100 which protrude from the proximal end of the proximal bendingmember18, after the assembly of theend effector16, inner andouter shafts32,34,adapter26 and proximal bendingmember18, are passed through the four terminal wire crimps or lugs102 which are keyed into passages in theinsert collar104. The cables are tensioned and crimped and excess cable material is trimmed off. This arrangement holds all the elements together between theend effector16 andinsert collar104 and, in turn, therotation knob24.
The lockingcables160 are anchored distally at162 at the distal end of the proximal bending member and pass through passages in the proximal bending member and theinsert collar104, as shown in the cross-sectional view ofFIG. 13. The cables then pass through passages in therotation knob24 and terminate at164 at theuniversal ring142. Theinsert collar104 androtation knob24 are mated together by means of theridges25 andchannels105. The lockingcables160 are tensioned and anchored proximally at terminatingend164 and excess cable material is trimmed off.
Therotation knob24 has a central aperture into which acone plunger180 passes. Thecone plunger180 has ahub184 at its distal end which is captured between therotation knob24 andinsert collar104. The retainingring186 holds theplunger180 relative to therotation knob24. Refer toFIGS. 5,8 and13. Mounted over thecone plunger180 is anexpansion sphere144 which in turn carries therider148 anduniversal ring142. Theuniversal ring142 is held on therider148 by a retainingring150 as best seen inFIGS. 13-16. It is the relative axial movement between thecone plunger180 and theexpansion sphere144 that provides the basic locking action and it is the axial transition of therotation knob24 that initiates this action.
Theexpansion sphere144 has preferably eight partiallyspherical petals146 at the end of amain shank152. Refer also to the cross-sectional view ofFIG. 9 for an illustration of thepetals146. The eightpetals146 form an expandable sphere with a conical cavity in the center shaped to accommodate thecone plunger180. Theexpansion sphere144 is adapted for limited axial sliding within the handle housing upon engagement with thecone plunger180, but with no rotation between theexpansion sphere144 and the handle. Theexpansion sphere144 is adapted to move only a slight distance axially, and in another embodiment may be supported so that it is axially fixed in position. Theexpansion sphere144 is provided with interlock means with thehandle12. Theshank152 of theexpansion sphere144 has two mating means in the form ofkeys156 that align withmating keyways157 on the sides of apassage168 throughwall166 ofhandle12. This interlocking allows theexpansion sphere144 to slide in and out of thehandle12 axially, but without rotating.
At theproximal end154 of theshank152 there are two opposedflexible fingers158 that interact with retention means194 on the handle to effect the locking and releasing of the conical rampedsurface182 within the conical cavity of the sphere. Basically, pulling on theknob24 toward the handle pushes thecone plunger180 into theexpansion sphere144. This action in turn causes theproximal end154 of theshank152 to contact thewall196. Retainingring150 may act as a thrust washer in this respect. Thespring arms190 of thefingers158 are urged outwardly by the cone shaped rampedsurface188, as seen inFIG. 14. This causes a ratcheting action at194. There is anelastic band192 to help retract thefingers158 when theknob24 is pushed forward (distally) once thefingers158 move off of theramp surface188.
FIGS. 13 & 14 illustrate the locking action.FIG. 13 shows the “at rest” position of the angle locking means140 andFIG. 14 shows how thecables160 push and pull the universal disc in response to the bending of the proximal bending member and also shows theknob24 pulled back, as illustrated by the arrow S. The resulting expansion by the plunger is illustrated by the arrows E that exerts a force that bears upon the inside of therider148 and hold it tightly in place while allowing theuniversal disc142 to rotate freely around the raceway formed by therider148 and the retainingring150.
The locking mechanism that is described herein is in the form of afollower mechanism140 that is disposed proximally of the rotation knob. The proximal motion member comprises a proximal bendable member and a plurality of lockingcables160 that intercouple between the follower mechanism and the proximal bendable member. In the present invention the locking occurs by means of the use of a separate follower member illustrated as lockingmechanism140. This follower mechanism operates in conjunction withlock cables160 to lock a particular position of the proximal bendable member, and by doing so also locking the position of the distal bendable member, as the proximal and distal bendable members are interconnected byactuation cables100.
Thelocking mechanism140 includes, inter alia, theanchor ring142 that provides the primary support for the lockingcables160, as well as the support of the locking mechanism from the rotation knob structure. In this regard, theanchor ring142 includes diametrically disposed pins172 that are accommodated in elongated slots174 of the opposed rearwardly extending fingers or arms170. Refer in particular toFIGS. 15 and 16. The fingers170 extend from the rotation knob barrel. This pin and slot arrangement enables thelocking mechanism140 to move with the bending and rotation action.
When the instrument illustrated in this embodiment is in a straight in-line position then the locking mechanism, and particularly theanchor ring142 extends substantially transverse to the center axis, as shown inFIG. 13. When thehandle12 is bent, such as in the positions shown inFIG. 14 then it is noted that thefollower locking mechanism140 tilts relative to the longitudinal axis T. When it is desired to lock the mechanism in a particular bent condition then the rotation knob is moved proximally (position ofFIG. 14), thecone plunger180 engages theexpansion sphere144 and this locks the position of theanchor ring142 and thus also locks the position of the locking oranchor cables160. This, in turn, locks the position of the proximalbendable member18 and via thecables100 also locks the position of the distalbendable member20. The rigidity of the lockingcables160 maintains the proximalbendable member18 in the locked position. Thecables160 are preferably substantially larger in diameter than theactuation cables100 and are thus more rigid than the actuation cables.
Each of thecables160 are disposed 90 degrees apart, as are thebent cables100. Refer toFIG. 7 for an illustration of the placement of these cables. It is noted that thecables160 are disposed 45 degrees to thecables100. This 45 degree different position is illustrated inFIGS. 7,8 and16. The distal end of eachcable160 terminates atlug end162. As indicated previously, the proximal end of eachcable160 terminates atlug164. A spring or resilient member may be associated with eachtermination164, but is not preferred. Rotation of therotation knob24 causes rotation of the entire proximal bendable member and thelocking mechanism140.
Thelocking mechanism140 includes, in addition to theanchor ring142, therider148 and the retainingring150. Fastening screws or the like may be used for securing together therider148 and the retainingring150 about theexpansion sphere144 as illustrated inFIGS. 13 and 14.FIG. 3 is a cross-sectional view of the instrument of this embodiment with the handle bent at an angle B1 which causes a corresponding bending at the distal end of the instrument at an angle B2 to the longitudinal shaft axis. In this embodiment the instrument can also be controlled in any direction including directions in and out of the plane of the paper. It is noted that the handle is bent downwardly causing a corresponding bending upwardly of the distal end of the instrument. As indicated previously the cable lengths of thecables160 are the same and thus when the handle is bent in the manner illustrated inFIG. 3 thelocking mechanism140 tilts relative to axis T and essentially follows the positioning of the proximal bendable member. Thelocking mechanism140 has the ability to tilt at any angle, can be controlled to lock thecables160 and thus the end effector position, but is able to rotate with rotation of theknob24.
FIG. 14 illustrates the same instrument illustrated inFIG. 13 but with the handle now tilted upwardly so as to provide a corresponding downward tilting at the distal end of the instrument. It is also to be noted that, with this direction of position of the handle, thefollower mechanism140 tilts in the opposite direction to that illustrated inFIG. 3. In the illustrative position ofFIG. 14 with the instrument locked the distal part of the instrument can be rotated via therotation knob24. This is because, even though therider148 is essentially locked with theexpansion sphere144, theuniversal ring142 is free to rotate upon rotation of therotation knob24. In this locked position theuniversal ring142 rotates in its own plane. The rotation causes the distal end of the instrument to rotate the tip (end effector) about a distal tip axis such as shown by the axis P inFIG. 3. The rotation occurs effectively even though the instrument is locked as to its position. In other words the orientation of the instrument can be changed by rotating theknob24, even though its position is fixed.
The instrument of the present invention provides an improved instrument, particularly from the standpoint of ease of use by the surgeon. The lever arrangement permits fine control by the user, particularly the embodiment that has the recess gimbal arrangement where the finger of the user can be engaged with the lever. Another feature is the combination of use of the rotation knob so that it functions, not only for rotation of the distal tip of the instrument, but also functions as the means by which the instrument can be locked in a particular position. This includes the preferred axial displacement of the rotation knob to perform the locking function. In an alternate embodiment of the present invention the rotation knob may move distally to lock rather than proximally by rearranging the plunger and expansion sphere. In another version of the present invention another form of rotation mechanism may be used such as a slide mechanism to control distal rotation about the tool tip axis. A locking function is still associated with such an arrangement, such as by depressing the slide mechanism to provide the lock function.
Having now described a limited number of embodiments of the present invention it should now be apparent to one skilled in the art that numerous other embodiments and modifications are contemplated as falling within the scope of the present invention as defined by the appended claims.