HK1133567B - Surgical instrument - Google Patents

Description

Surgical instrument

RELATED APPLICATIONS

In accordance with the provisions of 35u.s.c. § 119(e) (U.S. patent act 35, clause 119), the present application claims priority to commonly owned and co-pending U.S. provisional patent application No.60/844,130, filed 2006, 9, 13. The entire contents of the above-identified application are hereby incorporated by reference in their entirety.

Technical Field

The present invention relates generally to medical instruments and, more particularly, to manually operated surgical instruments intended for use in minimally invasive surgery or other forms of surgical or medical procedures. The instruments described herein are primarily intended for use in laparoscopic procedures, however, it should be understood that the instrument of the present invention can be used in a wide variety of other procedures, including intraluminal procedures.

Background

Endoscopic and laparoscopic instruments currently available on the market are extremely difficult to learn to operate and use, primarily because of their lack of dexterity in their use. For example, when using a typical laparoscopic instrument during surgery, the orientation of the tool of the instrument is dictated only by the location of the target and the incision. These instruments generally work by the fulcrum effect, using the patient's own incision area as a fulcrum. As a result, common tasks such as suturing, knotting and fine dissection become complicated for the physician. Various laparoscopic instruments have been developed over the years to overcome this drawback, typically by providing additional articulation means, which are typically controlled by separately provided control elements for additional control. However, even so, these instruments still do not provide sufficient dexterity to allow the surgeon to perform common tasks, such as suturing, particularly at arbitrarily selected orientations. At the same time, 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 to effectively control the instrument.

It is therefore an object of the present invention 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.

It is another object of the present invention to provide an improved surgical or medical instrument having a wide variety of applications through incisions, through natural body orifices, or through lumens.

It is a further object of the present invention to provide an improved medical instrument characterized by the ability to lock the instrument in a preselected specific position.

It is a further object of the present invention to provide a locking feature that is an important aid to other controls of the instrument so that the surgeon can lock the instrument once it is in the desired position. This allows the surgeon to more easily perform the surgical procedure thereafter without having to simultaneously hold the instrument in a particular curved configuration.

It is a further object of the present invention to provide an improved medical device which enables effective control by a user with a single hand.

Disclosure of Invention

To achieve the foregoing and other objects, features, and advantages of the invention, there is provided a surgical instrument comprising: an instrument shaft having a proximal end and a distal end; a tool disposed at a distal end of the instrument shaft; a control handle coupled to 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 control handle; an actuation device extending between the distal motion member and the proximal motion member for linking motion of the proximal motion member to the distal motion member for controlling positioning of the tool; and a locking mechanism for securing the position of the tool in a selected position and having a locked state and an unlocked state. Wherein the locking mechanism includes a ball and socket arrangement disposed about the proximal motion member and a strap member for locking the ball and socket arrangement, and wherein the ball and socket arrangement includes a ball member having a partially spherical portion that mates with a concave socket in the control handle.

According to another aspect of the invention, the surgical instrument may further comprise: a rotation device disposed adjacent to the control handle and rotatable relative to the control handle to cause corresponding rotation of the instrument shaft and the tool; at least the proximal motion member may comprise a proximal bendable member, wherein the rotation means comprises a knob adapted to rotate the tool about a distal tool roll axis and is disposed between the control handle and the proximal bendable member; the control handle may comprise a pistol grip handle having an engagement horn to assist in retaining the handle; the rotation means may comprise a knob disposed at a distal end of the handle and the horn is disposed proximal to the knob and above the pistol grip handle; preferably, the surgical instrument further comprises an actuation lever supported to the pistol grip handle at a pivot point at the proximal end of the handle; the actuating lever may have a free end with a finger loop for receiving a user finger to control the lever; preferably, the surgical instrument further comprises a tool actuation cable extending from the tool to the handle, a slider for grasping a proximal end of the tool actuation cable, and an actuation lever supported at the handle for controlling translation of the slider; preferably, the surgical instrument further comprises a slide for receiving the sled, a pair of springs disposed in the sled, and a rotary cylinder disposed between the springs for holding a proximal end of the tool actuation cable; the ball and socket arrangement may include a ball member having a partially spherical portion that mates with a concave socket in the handle; the handle may have a distal collar with the socket formed on an inner surface thereof, and the strap member may include an annular strap ring disposed about the distal collar; preferably, the surgical instrument further comprises a tongue and groove interconnection between the cinch ring and collar so as to allow rotation between the cinch ring and collar while preventing axial movement; preferably, the surgical instrument further comprises a pivot on the cinch ring having opposed locked and unlocked positions; and preferably the distal collar has one or more slots such that the socket can be retracted around the ball member when the band is locked.

According to another feature of the present invention, there is provided a surgical instrument comprising: an instrument shaft having a proximal end and a distal end; a tool disposed at a distal end of the instrument shaft; a control handle disposed at a 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; an actuation device extending between the distal motion member and the proximal motion member for linking motion of the proximal motion member to the distal motion member for controlling positioning of the tool; the control handle comprises a pistol grip type handle; an actuating lever for controlling the tool and pivotally supported to the handle; and an adjustment member mounted on the lever so as to adjust a posture or angle of the actuation lever with respect to a center plane of the handle.

According to yet another aspect of the present invention, there is provided a surgical instrument, wherein the adjustment member comprises an adjustment lever for changing the posture or angle between a positive value and a negative value; the adjustment member comprises a bevel washer arrangement; the adjusting lever is supported on the same pivoting support as the pivoting support for the actuating lever; and, the surgical instrument further includes an engagement horn to assist in retaining the handle and a knob disposed at a distal end of the handle, and the horn is disposed proximal to the knob and above the pistol grip handle.

According to another feature of the present invention, there is provided a medical device having: a proximal control handle and a distal tool coupled to each other by an elongated instrument shaft for passing through the interior of the anatomy; proximal and distal movable members that respectively interconnect the proximal control handle and the distal tool with the instrument shaft; a cable actuation device disposed between the movable members; the control handle has a proximal end and a distal end; an actuation lever for controlling the distal tool; means for pivotally supporting said actuating lever on one side thereof to the proximal end of said handle; a horn and means for fixedly supporting the horn on opposite sides thereof to the distal end of the handle.

According to a further aspect of the invention there is provided a medical instrument wherein the cable actuation means comprises a set of actuation cables, the cables being sufficiently stiff that each cable is capable of a pulling action or a pushing action in the control of the tool; the medical instrument further comprises a restraining means for each cable so as to substantially restrain each cable as it extends between the proximal and distal movable members; and, the control handle comprises a pistol grip handle and the actuation lever comprises an adjustment member mounted on the lever for adjusting the attitude of the actuation lever relative to a center plane of the handle.

According to a further feature of the present invention, there is provided a medical device, the device having: a proximal control handle and a distal tool coupled to each other by an elongated instrument shaft for passing through the interior of the anatomy; proximal and distal movable members that respectively interconnect the proximal control handle and the distal tool with the instrument shaft; a cable actuation device disposed between the movable members for controlling positioning of the distal tool; and means for constraining the cable means along its length to enable pulling and pushing actions.

According to a further aspect of the present invention there is provided a medical instrument, wherein the cable means is constrained along substantially its entire length; and, the constraining device includes a shaft filler disposed in the instrument shaft about the cable device.

According to another feature of the present invention, there is provided a medical device having: a proximal control handle and a distal tool coupled to each other by an elongated instrument shaft for passing through the interior of the anatomy; proximal and distal movable members that respectively interconnect the proximal control handle and the distal tool with the instrument shaft; a cable actuation device disposed between the movable members for controlling positioning of the distal tool; and a locking mechanism having a locked position and an unlocked position, disposed about said proximal movable member and manually controlled to fix the position of the proximal movable member relative to said handle in said locked position thereof.

According to other aspects of the present invention, a medical device is provided, wherein the locking mechanism includes a ball member and a compressible hub defining a socket member; the hub is a split hub and the locking mechanism further comprises a cinch ring disposed about the split hub and a locking lever mounted on the cinch ring for closing the cinch ring about the split hub to lock the hub to the ball member; the cinch ring interlocks with the hub but is rotatable relative to the hub when in the unlocked position; and, the medical instrument further comprises a rotational control member adjacent the proximal movable member for controlling the orientation of the distal movable member and the tool.

Drawings

It is to be understood that the drawings are provided for purposes of illustration only and are not intended to limit the scope of the disclosed invention. The foregoing and other objects and advantages of the embodiments described herein will be apparent from the following detailed description, taken in conjunction with the accompanying drawings, in which:

FIG. 1 is a perspective view of a preferred embodiment of the instrument of the present invention, showing the instrument held by a user and further schematically showing the instrument positioned at a surgical site;

FIG. 2 is a side cross-sectional view of the instrument of FIG. 1 itself, the cross-sectional view primarily showing the proximal or handle end of the instrument;

FIG. 3 is an enlarged side cross-sectional view of the instrument of FIG. 2 shown in an inclined relationship with the jaws closed on the needle;

4A-4C are exemplary side cross-sectional views of a distal end of a medical instrument with movable jaws in different respective positions;

FIG. 4D is a radial cross-sectional view taken along line 4D-4D of FIG. 4C;

FIG. 5 is a front cross-sectional view of the instrument of FIG. 1, taken along line 5-5 of FIG. 2, showing the locking lever in a locked position;

FIG. 6 is a front cross-sectional view of the instrument illustrated in FIG. 5, showing the locking lever in an unlocked position, and further showing the instrument with certain parts removed to illustrate certain adjustments that can be made to accommodate a user of the instrument;

FIG. 7 is a plan sectional view taken along line 7-7 of FIG. 2;

FIG. 8 is a partial cross-sectional view taken along line 8-8 of FIG. 5, but showing the instrument in an inclined relationship;

FIG. 9 is an enlarged cross-sectional view taken at line 9-9 of FIG. 8 at the instrument shaft;

FIG. 10 is a cross-sectional view at the adaptor of the instrument taken along line 10-10 of FIG. 8;

FIG. 11 is a cross-sectional view at the knob of the instrument taken along line 11-11 of FIG. 7;

12-14 are generally schematic enlarged fragmentary sectional views of the handle taken substantially along line 12-12 of FIG. 7, illustrating operation of the jaw clamping lever arrangement in its different positions;

fig. 15 is a schematic perspective view of the instrument illustrated herein.

Detailed Description

The instrument of the present invention may be used to perform minimally invasive procedures. As used herein, a "minimally invasive procedure" refers to a surgical procedure that is performed by a surgeon through a small incision or incision that is used to access a surgical site. In one embodiment, the length of the incision ranges from 1 mm to 20 mm in diameter, preferably from 5 mm to 10 mm in diameter. This procedure is in contrast to those procedures that require a large incision to access the surgical site. Therefore, flexible instruments are preferably used for insertion through such small incisions and/or through natural body lumens or cavities to position the instrument at an internal target site for a particular surgical or medical procedure. Introduction of the surgical instrument into the anatomy may also be performed by percutaneous or surgical access to a lumen, vessel or cavity, or by introduction through a natural orifice in the anatomy.

In addition to use in laparoscopic procedures, the instruments of the present invention may be used in a variety of other medical or surgical procedures including, but not limited to, colonoscopy, upper gastrointestinal tract, arthroscope, sinus, thoracic, prostate, transvaginal, orthopedic, and cardiac procedures. Depending on 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 the present invention are also applicable to other medical instruments, not necessarily for surgery, including, but not limited to, other instruments such as catheters, and diagnostic and therapeutic instruments and instruments.

There are a number of unique features included in the devices of the present invention. For example, there is provided a locking mechanism constructed using a ball and socket arrangement disposed about the proximal motion member which performs the bending action, wherein the ball and socket arrangement is clamped with an annular cinch ring in a fixed particular position, thereby also maintaining the proximal and distal bendable members in a particular bent state, or in other words, locked in that position. The cinch ring includes a locking lever that is conveniently located adjacent the instrument handle and is easily manipulated to lock and unlock the cinch ring and, in turn, the position of the end effector. The cinch ring is preferably also rotatable to enable the locking lever to be conveniently positioned or switched (rotated) between left and right handed users. This lockout control allows the surgeon to perform some tasks with one less degree of freedom. By locking the bendable section in a particular position, this allows the surgeon more freedom to control other degrees of freedom of the instrument, such as manipulating the knobs and thus the orientation of the end effector.

Another feature of the invention relates to the manner in which the bending is performed. In the past, smaller diameter flexible cables have been used to control bending between the proximal and distal bendable members. However, this results in a slightly uneven control, since there is only a "pulling" action by one cable, while the opposite cable is slack. The present invention uses a more rigid cable means that allows bending to occur in both a "pulling" action and a reverse "pushing" action. To do this, the cables are large in diameter and somewhat rigid, but must also be sufficiently flexible that they are easily bendable. At the same time, the cable is constrained along its length to prevent cable deflection or buckling, especially during the "pushing" stage of the cable.

Still another feature is a pistol grip handle arrangement and a control lever having an end gimbal structure that more precisely controls the actuation lever and provides corresponding actuation of the end effector. At the same time the control stick according to the invention is provided with means for controlling the posture of the control stick to compensate for different hand configurations, in particular to compensate for different lengths of the user's fingers.

FIG. 1 is a perspective view of one embodiment of a surgical instrument 10 of the present invention. In this surgical instrument, both the tool and the handle movement member or bendable member can be bent in any direction. They are interconnected via cables, preferably four cables, such that a bending action at the proximal member provides a relative bending at the distal member. Proximal bending is controlled by the motion or deflection of the control handle by the instrument user. In other words, the surgeon grips the handle and once the instrument is in place, any movement (deflection) at the handle directly controls the proximal bendable member, which in turn controls a corresponding bending or deflection at the distal bendable member via the cables. This action in turn controls the positioning of the distal tool.

The proximal member is preferably generally larger than the distal member to provide enhanced ergonomic control. In the illustrated embodiment, the ratio of the diameter of the proximal bendable member to the distal bendable member may be on the order of three to one. In one version according to the invention, a bending action may be provided in which the distal bendable member bends in the same direction as the proximal bendable member. In alternative embodiments, the bendable, rotatable or flexible member may be arranged to bend in opposite directions by rotating the actuation cable up to 180 degrees, or may be controlled to bend in virtually any other direction, depending on the relationship between the distal and proximal support points of the cable.

As noted, the amount of bending motion produced at the distal bending member is determined by the size of the proximal bendable member in comparison to the size of the distal bendable member. In such embodiments, the proximal bendable member is generally larger than the distal bendable member, and as a result, the magnitude of motion produced at the distal bendable member is greater than the magnitude of motion at the proximal bendable member. The proximal bendable member is capable of bending in any direction (about 360 degrees) and thus the distal bendable member is controlled to bend in the same or opposite direction but in the same plane at the same time. Moreover, as shown in fig. 1, the surgeon is able to bend and roll the tool of the instrument about its longitudinal axis T to any orientation simply by rolling the axial knob about the direction of rotation R1.

Reference is made in this description to bendable members. These members may also be referred to as rotatable members, bendable portions, or flexible members. In this description given herein, terms such as "bendable portion," "bendable section," "bendable member," or "rotatable member" refer to an instrument element that is controllably bendable in contrast to an element that pivots at a joint. The term "movable member" is taken as a general term for the bendable portion and the joint. The bendable elements of the present invention enable the manufacture of instruments that can be bent in any direction without any singularity, and that are also characterized by ready capability to bend in any direction, all preferably in a single unitary or monolithic structure. "integral" or "monolithic" structures are defined as structures that are constructed of only a single, unitary member, and not as structures formed of multiple assembled or mated parts.

These bendable members are defined as an instrument element that is formed as a control device or controlled device, i.e., capable of being constrained by tensile or compressive forces to deflect from a straight line to a curved configuration without any sharp or singular points. The bendable members may take the form of a unitary structure as shown in fig. 1 and 2 herein, may be formed of engageable discs or the like, may comprise corrugating means or may comprise movable ring assemblies. For other forms of bendable members reference is made to co-pending application No.11/505,003 filed on 16.8.2006 and No.11/505,003 filed on 19.9.2006, both of which are hereby incorporated by reference in their entirety.

Fig. 1 shows a preferred embodiment of the instrument of the present invention. Further details are shown in fig. 2 to 15. Fig. 1 shows the surgical instrument 10 in place, as would occur during a surgical procedure. For example, the instrument may be used for laparoscopic surgery through the abdominal wall, as shown at 4 in fig. 1. For this purpose, an insertion site is provided, at which a cannula or trocar 6 is provided. The shaft 14 of the instrument 10 is adapted to pass through the cannula or trocar 6 in order to position the distal end of the instrument at the surgical site. In fig. 1, the end effector 16 is shown at such a surgical site with the cannula or trocar 6 at the incision point in the skin 4. The embodiment of the instrument shown in FIG. 1 is generally used with a sheath 98 to prevent bodily fluids from entering the distal bending member 20.

A rolling motion is possible with the instrument of the invention. This can occur by virtue of the knob 24 being rotated about axis T (see fig. 3) relative to the handle 12. This is indicated in fig. 1 by the rotation arrow R1. When the knob 24 is rotated in either direction, this results in a corresponding rotation of the instrument shaft 14. This is illustrated in fig. 1 by the rotation arrow R2. This same motion also causes the distal bendable member and the end effector 16 to rotate about an axis corresponding to the instrument tip, shown in fig. 1 and 3 as about the longitudinal tip or tool axis P.

Any rotation of knob 24 while the instrument is locked (or unlocked) maintains the instrument tip in the same angular position, but rotates the orientation of the tip (tool). For further explanation of the tip rotation feature, reference is made to co-pending application serial No.11/302,654 filed on 12/14/2005, particularly fig. 25-28, which is hereby incorporated by reference in its entirety.

The handle 12 may be angled relative to the instrument shaft longitudinal central axis via the proximal bendable member 18. Such tilting, deflecting or bending can be considered to be in the plane of the paper. With the cable means, this action causes the distal bendable member 20 to correspondingly bend to a position in which the tip is oriented along the axis and at a corresponding angle to the instrument shaft longitudinal central axis. The bending at the proximal bendable member 18 is controlled by the surgeon via the handle 12 by manipulating the handle in substantially any direction, including in and out of the plane of the paper in FIG. 1. This manipulation directly controls the bending at the proximal bendable member. Referring to FIG. 3, an axis U corresponding to the instrument shaft longitudinal axis is shown. In addition, reference is made to a proximal bend angle B1 between axes T and U and a corresponding distal bend angle B2 between axes U and P.

Thus, the control at the handle is used to bend the instrument at the proximal motion member, thereby controlling the positioning of the distal motion member and the tool. The "position" of the tool is primarily determined by this bending or motion action and can be considered as a coordinate position at the distal end of the distal motion member. Indeed, one may consider coordinate axes at the proximal and distal motion members and at the instrument tip. The positioning is in three-dimensional space. Of course, instrument positioning is also controlled to some extent by the surgeon's ability to pivot the instrument at the incision point (cannula 6). On the other hand, the "orientation" of the tool relates to the rotational positioning of the tool about the illustrated distal tip or tool axis P by means of the proximal rotational control member.

In the drawings, a set of jaws is shown, however, other tools or devices may be readily adapted for use with the instrument of the present invention. Such other tools or devices include, but are not limited to, cameras, detectors, optics, scopes, fluid delivery devices, syringes, and the like. The tools may include a variety of articulating tools such as jaws, scissors, holders, needle holders, micro-dissectors, staple applicators, suture devices, suction irrigation tools, and clip applicators. Further, the tool may include a non-articulating tool such as a cutting blade, a stylet, an irrigator, a catheter, or a suction port.

The surgical instrument of fig. 1 shows a preferred embodiment of a surgical instrument 10 according to the invention in use, which can be inserted through a cannula through the skin of a patient at an insertion site. Many of the components shown herein, such as the instrument shaft 14, end effector 16, distal bending member 20, and proximal bending member 18, etc., may be similar to, and interact in the same manner as, the instrument components described in co-pending U.S. application serial No.11/185,911, filed on 7/20/2005, which is hereby incorporated by reference in its entirety. Many of the other components shown herein, particularly at the end of the instrument handle, may be similar to those described in co-pending U.S. application serial No.11/528,134 filed on 27.9.2006, which is hereby incorporated by reference in its entirety. Also incorporated by reference in its entirety is U.S. application No.10/822,081 filed on 12.4.2004; U.S. application serial No.11/242,642 filed on 3/10/2005 and U.S. application serial No.11/302,654 filed on 14/12/2005, all of which are commonly owned by the present assignee.

As shown in fig. 3-8, control between the proximal and distal bendable members 18, 20 is provided by means of bend control cables 100. In the illustrated embodiment, four such control cables 100 are provided to provide the desired omni-directional bending. However, in other embodiments of the invention, a lesser or smaller number of bend control cables may be used. The bend control cables 100 extend through the instrument shaft 14 and through the proximal and distal bendable members, as shown in fig. 3 and 4. The bend control cable 100 is constrained along substantially its entire length to facilitate "pushing" and "pulling" actions as described in one aspect of the invention, as described in further detail below. The cable 100 is also constrained as it passes through the tapered cable guide portion 19 of the proximal bendable member and through the proximal bendable member. See, for example, fig. 7 and 8.

The locking device of the present invention interacts with a novel ball and socket arrangement to lock and unlock the positioning of the cables, which in turn control the angle of the proximal bending member and the angle of the distal bending member and end effector. This locking control allows the surgeon one less degree of freedom to focus on when performing certain tasks. By locking the bendable section in a particular position, this allows the surgeon more hands to control other degrees of freedom of the instrument, such as manipulation of the knob 24 and thus the orientation of the end effector, etc.

The instrument shown in fig. 1 is of the pistol grip type. However, the principles of the present invention are also applicable to other forms of handles, such as linear handles and the like. In fig. 3, the jaw clamping device 30 is shown to generally include a lever 22, the lever 22 having a single finger hole for controlling the lever, and an associated release function that is directly controlled by the lever 22 rather than by a separate release button. The release function is used to release the actuated or closed tool and will be discussed in further detail below.

In the illustrated instrument, the handle end of the instrument can be deflected in any direction because the proximal bendable member is constructed and arranged to enable a full 360 degree bend. This movement of the handle relative to the instrument shaft bends the instrument at the proximal bendable member 18. This action in turn causes the distal bendable member to bend in the same direction via the bend control cables 100. As previously mentioned, by rotating or twisting the control cable up to 180 degrees from one end to the other, opposite direction bending can be utilized. Referring to the schematic perspective view of fig. 15, an illustration of a linear cable device for use in the illustrated instrument can be seen.

In the embodiments described herein, the handle 12 takes the form of a pistol grip and includes a horn 13 that facilitates comfortable contact between the action of the surgeon's hand and the instrument. The tool actuation lever 22 is shown pivotally attached to the handle base in fig. 1-3. The lever 22 actuates a slide 28, which slide 28 controls a tool actuation cable 38 extending from the slide to the distal end of the instrument. The cable 38 controls the opening and closing of the jaws, and the different positions of the lever control the force applied to the jaws.

The shape of the handle allows comfortable and substantially one-handed operation of the instrument as shown in fig. 1. As shown in FIG. 1, the surgeon may grasp the handle 12 between his palm and middle finger while the horn 13 rests at the web between his thumb and index finger. This allows the index finger and thumb to be released and positioned to rotate the knob 24 with the finger serrations 31 provided on the outer peripheral surface of the knob as shown in fig. 11. In both the locked and unlocked positions of the instrument, the knob is capable of controlled rotation to control axial rotation at the instrument tip about the distal tool tip axis P, as shown by rotation arrow R3 in fig. 1.

In the disclosed embodiment, a fingertip engaging recess 23 is provided in the gimbaled ball 27 at the tool closure lever 22. The free end of the stem 22 supports a gimbaled ball 27 having a through hole or recess 23, which through hole or recess 23 receives one of the user's fingers. The ball 27 is free to rotate at least partially in the three-dimensional space of the rod end. The surgeon may grasp the handle between the palm, ring finger and little finger with the horn 13 resting at the web between his thumb and forefinger, and may then operate the knob 24 as previously described. The surgeon may then operate the jaw clamping lever 22 with the index or middle finger.

The universal joint takes the form of a ball in a socket in which the ball 27 is free to rotate and the socket is defined in the free end of the rod. In this embodiment, rather than having a hole or recess 23 that extends completely through the ball, a blind hole is preferably provided in the ball. This blind hole is shown in fig. 5 and 6. The ball is free to rotate in the rod end, so the ball can also rotate to alternate positions corresponding to a right-handed user (fig. 5) or a left-handed user (fig. 6). The blind hole (as opposed to the through hole) enables the user to grip the lever more firmly, thus enabling enhanced control of the lever action.

Reference is now made to fig. 2-4. In this instrument, the distal bendable member 20 is shown without a protective sleeve to show some details of the distal bendable member 20. The distal bendable member includes a spacer disc 110 defining a spacer slot 112 therebetween. Ribs 111 may be attached between adjacent discs in a manner similar to that described in the aforementioned U.S. application serial No.11/185,911.

Referring also to fig. 4A-4D, further details of the tool end of the instrument can be seen. FIG. 4A shows the jaws in a fully open position. Fig. 4B shows the jaws holding the needle. Fig. 4C shows the jaws fully closed. Fig. 4D is a cross-sectional view taken along line 4D-4D of fig. 4C. The end effector 16 includes a pair of jaws 44 and 46. Jaws 44 and 46 may be used to hold a needle 45 or other object as shown in fig. 3. The upper jaw 44 fits within a channel 47 in the lower jaw 46. A pivot pin 48 is used between the jaws to effect rotation therebetween. The translation pin 42 extends through the slot 50 of the jaw 46 and the slot 52 of the jaw 44 and engages with a hole in the distal cable end connector 40. A connector 40 is secured to the distal extremity of the jaw actuation cable 38 and is positioned within the channel of the jaw 44. When the lever 22 is in the rest position, as shown in fig. 2, the jaws are fully open. In this position, the pin 42 is in a distal position that maintains the jaws in an open position. When the cable 38 is pulled, as shown proximally in FIG. 3, the pin 42 moves to the right of the slots 50 and 52, causing the jaws 44 and 46 to pivot toward the closed position.

Fig. 4A-4D also illustrate an end wall or plate 54 of jaw 46. One end of the distal bendable member 20 bears against the end wall 54. The member 20 may be secured to the wall 54 by suitable means. In one embodiment, the cable means tension of the instrument itself holds the members together. A pair of anchors 56 and 58 for the flexible control cable 100 are provided on the end wall 54. Fig. 4D shows four such cables 100. The distal end of the distal bendable member 20 may be provided with a pocket for receiving the anchors 56 and 58. Anchors 56 and 58 are rigidly attached to end wall 54. Referring also to fig. 15, a depiction of the cable connections and cable routing at opposite ends of each cable 100 can be seen.

Knob 24 is provided with a proximal hub 25, which proximal hub 25 supports the proximal end of proximal bending member 18. During assembly, cable 100 extending from the proximal end of proximal bending member 18 passes through four terminal coils or ears 102 after assembly of end effector 16, inner and outer shafts 34, 32, adaptor 26, and proximal bending member 18, with these coils or ears 102 being embedded in passages in hub 25. The cable is tensioned and crimped and excess cable material is trimmed. This configuration holds all of the elements together between the end effector 16 and the knob hub 25 and thus the knob 24.

As previously indicated, the knob 24 is formed with a hub 25 on its proximal side, the hub 25 being supported on a central new conduit 64 extending rearwardly from the knob 24 to the slide 28. The e-ring 65 retains the hub 25 in a rotational relationship relative to the conduit 64. The catheter 64 is supported in a fixed position by internal means of the handle 12. The knob 24 is easily accessible through the gap 232 between the split hub 202 and the distal end of the handle. The gap 232 can be seen in fig. 7. Knob 24 has four keyhole-shaped slots 103 (fig. 11), said slots 103 matching terminal coils 102A-102D, said terminal coils 102A-102D being capable of producing a "push-pull" action on cable 100 when the handle is bent relative to the shaft, in contrast to previous solutions where the cable is in a spring-loaded "pull" relationship relative to the knob. Due to this "push-pull" action, no biasing springs associated with each cable are used.

As previously indicated, the end effector or tool 16 is actuated by means of a jaw actuation mechanism or jaw clamping device 30, the jaw actuation mechanism or jaw clamping device 30 generally comprising an elongated rod 22. The lever 22 is supported to the housing at a lever pivot pin 72. Referring to fig. 2 and 3, closure of the lever 22 relative to the handle 12 acts on the slider 28, which slider 28 serves to grip the very proximal end of the actuation cable 38. When the slide 28 is in the position shown in fig. 2, the jaws of the end effector can be seen fully open. In this position, the slider 28 is disposed at the distal end of the slideway 84. The slide 84 is part of an internal support means in the handle 12. When the slider 28 is moved proximally, as shown in FIG. 3, the jaws are moved toward a closed position where the needle 45 is grasped.

The instrument shaft 14 includes an outer shaft tube 32 which may be constructed of a lightweight metal material or may be a plastic material. See fig. 9 for a cross-sectional view taken through the instrument shaft. The proximal end of the tube 32 is received by the adaptor 26 as shown in fig. 7 and 8. The distal end of the tube 32 is secured to the distal bendable member 20. A support tube 34, preferably made of a plastic material, is provided within the outer shaft tube 32. A tube 34 extends between the distal bendable or flexible member 20 and the proximal bendable or flexible member 18. A jaw actuation cable 38 extends within the support tube 34.

One feature of the present invention is a cable design that uses bend control cables that are relatively stiff and yet capable of bending. The stiffer cable allows not only a "pulling" action but also a "pushing" action. This enables enhanced control via the cable arrangement, as control is provided not only when "pulling" the cable but also when "pushing" the cable. This allows for more consistent control via the cable. To enable not only a "pulling" action but also a "pushing" action, the cable 100 is supported in a relatively narrow lumen or passageway to prevent buckling when pushed. This is facilitated by, among other things, the provision of the shaft filler 36. To enable a particularly "pushing" action, the cable is constrained so that it does not twist within the instrument itself.

A shaft filler 36 is provided between the tubes 32 and 34, the shaft filler 36 serving to hold the cables in place within the instrument shaft itself. As can be seen in fig. 9, the shaft filler has a central lumen 36A for the inner shaft support tube 34 and four longitudinal grooves 36B that house the cables 10 and allow the cables 100 to be a tight sliding fit. The tapered portion 19 of the proximal bending member 18 has cable guide grooves 106 disposed at 90 degree intervals around its outer surface, the guide grooves 106 gripping respective cables in sliding relationship with the hub 26. Each guide groove is formed in a separate radially disposed wing 108 of the cone 19. The adaptor 26 may also be provided with a receiving channel for the cable 100. Referring also to the cross-sectional view of fig. 10, an illustration of the cable guiding and restraining device can be seen. Thus, the cable is constrained in the groove or channel along its length. The individual cables are preferably unsupported for only a short distance, such as the distance of slots 132 shown in fig. 2 and 3, or as slots at the distal bendable member.

The jaw actuation cable 38 terminates at its respective ends at the end effector (link 40) and the rotation cylinder 66 (see fig. 3). Plastic tubing is provided within each of the bendable portions or bendable members 18 and 20. This includes a distal tube 60 and a proximal tube 62. These tubes may each be constructed of a plastic such as Polyetheretherketone (PEEK). The material of the tube is sufficiently stiff to grip the cable 38, yet flexible enough that it can be easily bent along with the bending of the bendable members 18 and 20. The tube is of sufficient strength to receive and guide the cable, yet flexible enough so that it does not kink or twist, thereby maintaining the cable in the correct state for actuation, while also defining a fixed length for the cable. The tube is rigid in the longitudinal direction and flexible in the lateral direction.

The proximal bendable member 18, like the distal bendable member 20, may also be constructed as a unitary or monolithic slotted structure including a set of flexible disks 130 with slots 132 defined between the flexible disks 130, as shown in FIG. 2. An "integral" or "monolithic" structure may be defined as a structure that is constructed to be used in a single piece and without the need for assembly of parts. Connecting ribs 131 are shown extending between adjacent disks 130. Both bendable members preferably have a rib pattern in which the ribs are arranged offset from one rib to an adjacent rib by preferably 60 degrees. This has been found to provide an improved bending action. It has also been found that bending can be improved by providing the ribs at a spacing therebetween of less than 90 degrees. The ribs may be disposed at a spacing of between about 35 degrees and about 75 degrees from one rib to an adjacent rib. By using a spacing of less than 90 degrees, the distribution of the ribs will be more uniform. As a result, the bending motion is more consistent in any orientation. In the present invention, both bendable members may be made of a highly elastic polymer such as PEBAX (block polyether amide), but may also be made of other elastic and resilient materials.

In fig. 2 the lever 22 is shown in a lowermost position which can be considered to be a "rest" position. This position is also approximately the same position as shown in fig. 7 and 12. This position may be achieved in some instruments by the action of a return spring 82 in a bore 80 of the slider 28, or in other embodiments of the instrument where a return spring is not used, by the surgeon manually moving the rod to this position.

Figures 2 and 3 show the lever 22 passing through a slot 73 in the handle and mounted to a pivot pin 72. The arm 70 of the lever 22 has a cylindrical head 71, the head 71 mating with a recess 74 in a boss 75 at the proximal end of the slide 28. The slider 28 sits in the slide 84 and moves proximally and distally in response to the lever position and/or return spring action. The slider 28 carries a rotatable cylinder 66, which cylinder 66 is clamped to the push/pull cable 38 by means of an adjusting screw 67 or the like. The barrel 66 is rotatable in response to rotation of the instrument shaft and end effector. Referring also to fig. 7, further details of the slider mechanism can be seen. The cylinder 66 is seated in a slot 68 which slot 68 is open at one end to an adjacent slot 78 and closed at its other end by a wall 69. The wall 69 has a through hole that serves as a guide for the push/pull cable 38, which cable 38 extends from the proximal end of the barrel 66, thus guiding the barrel action itself. The cylinder 66 is urged against the wall by a compression spring 76, the compression spring 76 being disposed in a slot 78. As shown in FIG. 2, the position of the lever causes the jaws to be fully opened as also shown in FIG. 4A. Further details of the operation of the lever and slider are known with reference to co-pending application serial No.11/528,134 filed on 27.9.2006.

The jaw clamping lever 22 is also adjustable for left and right hand operation and ranges from angle C in fig. 5 to angle D in fig. 6. This is accomplished by means of a cam lever 240 at the base of the handle that rotates approximately 180 degrees about the shaft 72, which shaft 72 also supports the jaw clamping lever 22. Control by the lever 240 may also be by rotation through other angles. The cam lever 240 substantially adjusts the attitude of the clamping lever 22 relative to a centerline or center plane of the handle, which is represented by the line or plane W in fig. 5 and 6, which illustrate the attitude in the opposite direction depending on the position of the lever 240. This adjustment can be made based on whether the user is right or left handed, or can be made based on some other characteristic of the user's hand, such as finger length, etc.

The cam lever 240 includes a wedge-shaped washer 242 with a truncated ball 244, the truncated ball 244 being formed on an inner inclined surface of the washer portion. The ball and washer have a through hole 246, the through hole 246 fitting over the shaft 72 and allowing the lever to pivot up or down about the shaft 72 from a forward position relative to the base of the handle to a rearward position, as seen in fig. 5 and 6. The ball 244 has a mating feature shown at 248 in fig. 6, and preferably takes the form of two slots that mate with two lugs on a cam plate 250. These mating features synchronize the rotation of the lever 240 and the cam plate 250. The cam plate 250 is also basically a wedge washer with a through bore 252, the through bore 252 allowing the cam plate 250 to pivot about the shaft 72 in response to rotation of the cam lever 240. The cam plate 250 is shown in fig. 6 as having two detent recesses 254 on its outer face that interact with two projections (not shown) on the sides of the slot 73 to preferably retain it in either of the two positions shown in fig. 5 and 6. The ball 244 sits in a bore 256 of the lever 22 and allows the lever 22 to change angle in response to rotation of the cam lever 240 and the relative positions of the inclined surfaces of the disks 242 and 250.

The jaw gripping device 30 utilizes a ratchet and release mechanism, one set of positions of which is shown in FIGS. 12-14. The ratchet mechanism is illustrated by a leaf spring 92 with a beveled end 94, the beveled end 94 engaging the teeth 86 on the slider 28 when the lever 22 is pressed. FIG. 12 illustrates the mechanism in an initial position, such as the position shown in FIG. 2 corresponding to the open jaw position. Fig. 13 shows the clamping lever in the raised position with the end 94 of the spring 92 engaging one of the teeth 86 on the slide 28. To release the jaws, lever 22 is squeezed all the way to the position of FIG. 14 where wall 69 contacts latch 96 and rotates latch 96 counterclockwise about pivot 90 until spring 92 is lifted out of engagement with teeth 86 by latch face 96B engaging the underside of spring 92. Fig. 14 shows the leaf spring 92 lifted out of engagement with the ratchet teeth 86. This action frees the slide 28 to move to the left as viewed in figure 14 until the wall 79 contacts the latch 96 and rotates it clockwise about the pivot 90 until the surface 96A is aligned with the underside of the spring, allowing it to drop into engagement with the end of the slide 28, just to the rear of the teeth 86, as in the position shown in figure 12.

Spring 92 and teeth 86 form a ratchet arrangement in which lever 22 can be snapped through several locations in closing the end effector and causing the jaws of the end effector to grip around an object, such as a needle. As the lever 22 is pressed inwardly towards the handle, the free end 94 of the leaf spring 92 engages with the various teeth on the slider. The jaws are gripped by each successive clip until the article being gripped is fully engaged. To release the actuation sequence, rather than using a separate release button, the lever 22 is simply moved to its innermost position, as shown in FIG. 14, in which the latch 96 engages the wall 79. This pivots the latch to a position where it lifts the spring 92, thus disengaging the spring from the teeth on the slider and allowing the slider to move to its release position under the bias of the spring.

The locking mechanism or angle locking means 140 of the present invention comprises a ball and socket arrangement which is provided substantially over the proximal bendable member and follows the bending at the proximal bendable member. The locking mechanism has a locked position and an unlocked position, is disposed about the proximal movable or bendable member and is manually controlled such that the position of the proximal movable member relative to the handle is fixed in its locked position. The locking mechanism includes a ball member and a compressible hub defining a socket member. In a disclosed embodiment, the hub is a split hub and the locking mechanism further includes a cinch ring disposed about the split hub and a locking lever mounted on the cinch ring for closing the cinch ring about the hub to lock the hub relative to the spherical ball member. The cinch ring interlocks with the hub, but is rotatable relative to the hub when in the unlocked position.

The "ball" portion is formed substantially by the ball member 120, while the "socket" portion is formed substantially by the handle extension, namely split hub 202. The locking mechanism locks the proximal bendable member in the desired position and by doing so the locking mechanism also locks the position of the distal bendable member and the tool. Although the proximal bending member 18 is surrounded by a ball and socket arrangement, it still allows the instrument shaft 14 and the proximal bending member 18 to rotate freely along with the cable 100, while also allowing the axis of the instrument shaft to tilt in a free or alternative locking mode relative to the axis of the handle.

Reference is made to ball member 120 for this purpose, which is shown in further detail in fig. 5-8. The ball member 120 includes a distal neck 206, the distal neck 206 abutting a partially spherical ball end having a spherical outer surface 204. The neck 206 is disposed substantially over the tapered section 19 and the adaptor 26 of the proximal bendable member 18, while the ball section is disposed primarily over a major portion of the proximal bendable member 18. The ball member 120 is adapted to be seated in a socket formed in the handle in the form of a hub 202, which hub 202 is collapsible about the ball member 120 by radially compressing the cinch ring 200.

The ball member 120 is gimballed engaged in a split hub 202, the split hub 202 comprising four segments 202A-202D, which segments 202A-202D can be clamped on a spherical surface 204 of the ball member 120 by means of a cinch ring 200. Refer to fig. 8. The split hub 202 is supported at the distal end of the handle by means of three struts 230, the three struts 230 being approximately 120 degrees apart (see FIG. 11). The ball member 120 has a neck 206 that provides support for the distal end of the proximal bendable member 18. In this regard, a bearing surface 208 is provided between the proximal end of the neck 206 and the adaptor 26, as shown in fig. 7 and 8. This enables the proximal bendable member, along with the adaptor 26, to rotate freely relative to the ball member 120. Fig. 7 and 8 also show a bearing surface 210 between the extreme distal end of the neck 206 and the outer tube 32. These bearing surfaces 208, 210 may be formed by actual bearings at these locations.

Fig. 5-8 illustrate a cinch ring 200. Reference is also made to fig. 2 and 3 to see an illustration of the cinch ring 200. The cinch ring 200 is an annular member having internal ridges or splines 201, the internal ridges or splines 201 adapted to mate with channels or grooves 203 on the outer surface of the split hub 202. This combination of channels and ridges restricts the annular strap member from rotating only about the hub 202. FIG. 8 also shows that each portion 200A-200B of the split hub is connected to the instrument handle via a respective strut 230 (see also FIG. 11). When the cinch ring 200 is closed, this in turn closes the slotted hub and essentially compresses the socket (hub 202) against the spherical surface 204 of the ball member 120. The locking of the ball member thus fixes the position of the proximal bendable member and thus the distal bendable member and the tool.

The cinch ring 200 is operated by means of an eccentric locking lever 220, which locking lever 220 is connected to the ends 200A and 200B of the cinch ring 200 by means of pins 222 and 224, respectively. Fig. 5 shows the locking lever 220 in a locked position, while fig. 6 shows the locking lever in a released or unlocked position. The end 200A of the cinch ring 200 takes the form of a removable hook that snap fits over the pin 222 and seats in the slot 226 of the lever 220 when the ring is locked. The other end 200B of the cinch ring 200 takes the form of two snap-fits over pins 224 formed on the sides of the lever 220. When the lever 220 is released by means of the spline 201, the cinch ring 200 is free to rotate around the split hub 202, the spline 201 riding in a groove 203 in the circumference of the split hub 202. This allows left or right handed operation of the instrument. Fig. 5 shows a set state for a right-hand operation, in which the angular locking lever 220 is shown in a locked position, and fig. 6 shows a set state for a left-hand operation, in which the angular locking lever 220 is shown in an unlocked position.

When the locking lever 220 is moved to its locking position, this compresses the cinch ring 200, closing the hub against the spherical outer surface 204 of the ball member 120. This locks the handle to the ball member 120, thereby holding the ball member in whatever position it is in when the locking occurs. By maintaining the ball member in a fixed position, this likewise maintains and fixes the proximal bendable member in a particular position. This in turn maintains the distal bendable member and tool in a fixed position, but enables control of the orientation of the instrument via control of a knob that controls the orientation of the instrument tip by rotating the distal bendable member and tool about the tip axis P (see fig. 3).

The instrument of the present invention provides an improved instrument, particularly from the standpoint of ease of use by the surgeon. The tool actuated lever arrangement allows a user to make precise controls, particularly using an instrument arrangement with a recessed gimbal where the user's fingers can easily engage the lever. Such a device also enables the instrument to be easily adapted for either right-handed or left-handed control by simply rotating the universal joint between opposite positions in the socket. It is also preferred that the recess in the universal joint is formed by a blind bore (with a bottom wall) as this has been found to provide enhanced manual control of the positioning of the stem.

Another improvement to the instrument of the present invention relates to the ability to easily control the tool, including convenient placement of the rotating member and convenient placement of the locking means, wherein the user's thumb and forefinger can be easily used to control tip rotation and locking. These functions can be performed with a single hand without the user moving the position of the hand.

Having now described a limited number of embodiments of the invention, it will be apparent to those skilled in the art that numerous other embodiments and modifications can be devised which fall within the scope of the present invention as defined by the appended claims. For example, in another variation of the present invention, a different form of instrument tip rotation device may be used, such as a sliding mechanism to control distal rotation about the tool tip axis. Even with such an alternative arrangement, a locking tool may still be associated with the instrument to provide the locking function. The locking device described herein is described as using a pistol grip handle, however, it could also be provided with an in-line instrument of the type described in application serial No.11/185,911 filed on 7/20/2005, for example. Also, in the instruments described herein, the movable members have been described as bendable portions, and more particularly, as integral bendable portions. Alternatively, however, the movable member may be other structures including, but not limited to, an engageable disc, a bellows arrangement, a movable ring arrangement, or a ball and socket member. Other forms of bendable members refer to copending provisional application No.60/802,885 filed on 23/5/2006 and copending provisional application No.60/811,046 filed on 5/6/2006, both of which are incorporated by reference herein in their entirety. Also, in the instruments described herein, the ball and socket arrangement has a ball portion that is a separate member that mates with a socket attached to the handle. In yet another embodiment of the invention, the ball and socket arrangement may comprise a separate socket member that mates with the protruding ball of the handle.

Claims (18)

1. A surgical instrument, comprising:

an instrument shaft having a proximal end and a distal end;

a tool disposed at a distal end of the instrument shaft;

a control handle coupled to 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 control handle;

an actuation device extending between the distal motion member and the proximal motion member for linking motion of the proximal motion member to the distal motion member for controlling positioning of the tool;

and a locking mechanism for securing the position of the tool in a selected position and having a locked state and an unlocked state,

wherein the locking mechanism includes a ball and socket arrangement disposed about the proximal motion member and a strap member for locking the ball and socket arrangement, and wherein the ball and socket arrangement includes a ball member having a partially spherical portion that mates with a concave socket in the control handle.

2. The surgical instrument of claim 1, further comprising a rotation device disposed adjacent to the control handle and rotatable relative to the control handle to cause corresponding rotation of the instrument shaft and the tool.

3. The surgical instrument of claim 2 wherein at least said proximal motion member comprises a proximal bendable member, said rotation means comprises a knob adapted to rotate said tool about a distal tool roll axis, and said knob is disposed between said control handle and said proximal bendable member.

4. The surgical instrument of claim 2 wherein the control handle comprises a pistol grip handle having an engagement horn to assist in retaining the control handle.

5. The surgical instrument of claim 4, wherein the rotation device comprises a knob disposed at a distal end of the control handle, and the engagement horn is disposed proximal to and above the knob.

6. The surgical instrument of claim 4, comprising an actuation lever supported to the control handle at a pivot point at a proximal end of the control handle.

7. The surgical instrument of claim 6, wherein the actuation lever has a free end with a finger loop for receiving a user's finger to control the actuation lever.

8. The surgical instrument of claim 1, comprising a tool actuation cable extending from the tool to the control handle, a slider for grasping a proximal end of the tool actuation cable, and an actuation lever supported at the control handle for controlling translation of the slider.

9. The surgical instrument of claim 8, comprising a slideway for receiving the sled, a pair of springs disposed in the sled, and a rotating cylinder disposed between the springs for holding a proximal end of the tool actuation cable.

10. The surgical instrument of claim 1, wherein the control handle has a distal collar with the female socket formed on an inner surface thereof, and the strap member comprises an annular strap ring disposed about the distal collar.

11. The surgical instrument of claim 10, comprising a tab and groove interconnection between said annular cinch ring and said distal collar to allow rotation between said annular cinch ring and said distal collar while preventing axial movement.

12. The surgical instrument of claim 11, comprising a pivot on the endless cinch ring having opposing locked and unlocked positions.

13. The surgical instrument of claim 10, wherein the distal collar has one or more slots such that the female socket is retractable about the ball member when the annular band is locked.

14. The surgical instrument of claim 6, comprising an adjustment member mounted on the actuation lever for adjusting the attitude of the actuation lever relative to a center plane of the control handle.

15. The surgical instrument of claim 6, wherein the actuation device is a cable actuation device.

16. The surgical instrument of claim 15 wherein said cable actuation means comprises a set of actuation cables that are sufficiently stiff that each actuation cable is capable of either a pulling action or a pushing action in controlling the tool.

17. The surgical instrument of claim 16 including constraining means for each actuation cable to substantially constrain each actuation cable as it extends between the proximal and distal motion members.

18. The surgical instrument of claim 17, wherein the constraining means comprises a shaft filler disposed in the instrument shaft about the actuation cable.