Detailed Description
The instrument of the present invention may be used to perform minimally invasive procedures. "minimally invasive procedure" herein refers to a surgical procedure in which a surgeon performs a procedure through a small incision or incision, which may be used to access a surgical site. In one embodiment, the length of the incision ranges from a diameter of 1mm to a diameter of 20mm, preferably from a diameter of 5mm to a diameter of 10 mm. This procedure is in contrast to those procedures that require a large incision to access the surgical site. Thus, flexible instruments are preferably used to be inserted through such small incisions and/or through body lumens or cavities to position the instrument at an internal target site for a particular surgical or medical procedure. The introduction of the surgical instrument into the anatomical tissue may also be percutaneous or surgical access to a lumen, vessel or cavity or through a body orifice in the anatomical tissue.
In addition to being used in laparoscopic procedures, the instruments of the present invention may also be used in a variety of other medical or surgical procedures, including but not limited to colonoscopic procedures, upper GI endoscopic procedures, arthroscopic procedures, sinus examination procedures, chest examination procedures, prostate examination procedures, transvaginal examination procedures, orthopedic surgical procedures, and cardiac examination 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 may also be applied to other medical instruments, not necessarily surgical, including, but not limited to, catheters, and other instruments such as diagnostic and therapeutic instruments and implements.
One of the main features of the present invention is the ability to reposition the control handle during a medical procedure. In this regard, there are at least two different ways in which this repositioning can be achieved. In a more simplified embodiment, a clutch member is provided that can be actuated at the proximal end of the instrument to either couple the proximal and distal members for consistent operation or to allow the handle to move freely for repositioning without substantially affecting the distal member. Another embodiment of the present invention uses the same clutch members, but further adds means for clamping the cable actuation means to maintain a specific position at the distal end of the instrument while performing proximal repositioning.
In the case of the clutch members described above, a number of different embodiments are disclosed herein and may be in the manner of followers, i.e., for terminating the proximal ends of the actuation cables rather than having them terminate at the proximal bendable members. The follower, when locked, defines a terminal end for the actuation cable, thereby enabling direct control between the proximal and distal bendable members. This enables repositioning of the proximal control handle without substantially affecting the position of the distal end of the instrument in one embodiment when the follower is unlocked.
Another feature that the instrument may include is a locking feature that maintains the proximal and distal bendable members in a particular bent state. This lockout control allows the surgeon to concentrate on performing a particular task with one of the reduced degrees of freedom. By locking the curvable portion in a particular position, this can make the surgeon's hand more free to control other degrees of freedom of the instrument, such as manipulating a rotation button to further control the orientation of the end effector.
There are a number of unique features implemented in the instrument of the present invention. For example, a locking mechanism is provided which is constructed using a ball and socket arrangement provided adjacent the proximal motion member which is compliant to the bending action and an annular gripping ring for holding the ball and socket arrangement in a particular position, and thus also the proximal and distal bendable members in a particular bent position-or in other words, locked in that position. The gripping ring may include a locking lever that is conveniently positioned adjacent the instrument handle and easily manipulated to lock and unlock the gripping ring, and further lock and unlock the position of the end effector. The grip ring is also preferably rotatable so that the locking bar can be conveniently positioned or switched (rotated) between left and right handed users. This lockout control allows the surgeon to concentrate on performing a particular task with one of the reduced degrees of freedom. By locking the curvable portion in a particular position, this allows the surgeon's hand more freedom to control other degrees of freedom of the instrument, such as manipulating a rotation button to further control the orientation of the end effector. In another embodiment shown herein, the locking feature may be implemented with a handle, socket and ball arrangement by means of a locking switch.
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 moving member or bendable member can be bent in any direction. They are interconnected by cables (preferably four cables) in such a way that the bending action at the proximal member provides the relevant bending at the distal member. Proximal bending is controlled by the user of the instrument through movement or deflection of the control handle. In other words, the surgeon grips the handle and any movement (deflection) at the handle immediately controls the proximal bendable member when the instrument is in place, which in turn controls a corresponding bending or deflection at the distal bendable member via the cable 100. This action in turn controls the positioning of the distal tool.
The proximal member is preferably generally larger than the distal member in order to provide better ergonomic control. In the illustrated embodiment, the ratio between the diameter of the proximal bendable member and the diameter of the distal bendable member may be on the order of 3 to 1. In one form according to the invention, a bending action may be performed in which the distal bendable member bends in the same direction as the proximal bendable member. In alternative embodiments, the rotatable or flexible member may be arranged to bend in opposite directions by rotating the actuation cable 180 degrees, or may be controlled to effectively bend in any other direction depending on the relationship between the distal and proximal support points for the cable.
It has been noted that the amount of bending motion that occurs at the distal bending member is determined by comparing the size of the proximal bending member with the size of the distal bending member. In the described embodiment, the proximal bendable member is generally larger than the distal bendable member, and thus the magnitude of the motion generated at the distal bendable member is greater than the magnitude of the motion generated at the proximal bendable member. The proximal bendable member is capable of bending in any direction (about 360 degrees) thereby controlling the bending of the distal bendable member in the same direction or in the opposite direction, but causing the distal bendable member to bend simultaneously in the same plane. Moreover, as shown in fig. 1 and 5, the surgeon can bend and roll the instrument tool to any orientation about its longitudinal axis T simply by rolling the axial rotation button 24 about the direction of rotation R1.
In this specification reference is made to bendable members. These members may also be referred to as rotatable members, bendable portions, or flexible members. In the description herein, terms such as "bendable portion," "bendable section," "bendable member," and "rotatable member" refer to an element of the instrument that is capable of controlled bending as compared to an element that pivots at a joint. The term "movable member" is considered to be a generic concept of bendable portions and joints. The bendable members of the present invention enable the manufacture of instruments that can be bent in any direction without any singularities and are further characterized by the ability to be easily bent in any direction, all of which have a single or unitary construction. The definition of "monolithic" or "one-piece" structures is: a structure constructed of only a single unitary member rather than a plurality of assembled or mated components.
These bendable members are defined as instrument elements that are formed either as control devices or as controlled devices and that can be constrained by tensile or compressive forces to deviate from a straight line into a bent configuration without any abrupt breaks or angulations. The bendable member may be a unitary structure such as that shown here in fig. 2 and 4, may be comprised of an engageable disc or the like, may include a bellows structure, or may include a movable ring assembly. For other forms of bendable members, see co-pending application serial No. 11/505,003 filed on 8/16 2006 and No. 11/523,103 filed on 9/19 2006, both of which are hereby incorporated by reference in their entirety.
FIG. 1 illustrates one embodiment of the instrument of the present invention. Figures 2 and 3 show more detail. Fig. 4-7 illustrate in sequence the manner in which the instrument can be repositioned. Fig. 1 illustrates a surgical instrument 10 in one manner in which a handle 12 is in an in-line configuration. In an alternative embodiment, such as shown in fig. 15 herein, the handle may be in the form of a pistol grip. For further details on the construction of a pistol grip instrument, see co-pending application serial No. 11/528,134 filed on 27.9.2006 and No. 11/649,352 filed on 2.1.2007, both of which are hereby incorporated by reference in their entirety.
By way of example, the instruments described herein may be used to perform laparoscopic surgery through the abdominal wall. For this purpose, an insertion site is provided, at which a cannula or trocar is provided. The shaft 14 of the instrument 10 is adapted to pass through a cannula or trocar in order to position the distal end of the instrument at a surgical site. An end effector 16 is shown in fig. 1. The embodiment of the instrument shown in fig. 1 may be used with a sheath 98 to prevent bodily fluids from entering distal bending member 20.
The apparatus of the present invention performs a rolling motion. This is done by rotating the rotary knob 24 about the axis P (see fig. 2) relative to the handle 12. This is indicated in fig. 1 by the rotation arrow R1. This causes rotation of the instrument shaft 14 when the rotation button 24 is rotated in either direction. This is illustrated in fig. 1 by the rotation arrow R2. This same motion also causes a rotation R3 of the distal bendable member and end effector 16 about an axis corresponding to the instrument tip, about the longitudinal tip or tool axis T shown in fig. 5.
Any rotation of the rotation button 24 when the instrument is locked (or unlocked) maintains the instrument tip in the same angular position, but turns the orientation of the tip (tool). For further explanation of the end rotation feature, see co-pending application serial No. 11/302,654 filed on 12/14/2005, particularly with reference to fig. 25-28, which is hereby incorporated by reference in its entirety.
The handle 12 may be tilted at an angle relative to the instrument shaft longitudinal central axis by the proximal bendable member 18. The tilting, deflecting or bending can be considered to be in the plane of the paper. By means of the cable, this action causes a corresponding bending of the distal bendable member 20 to a position where the tip is directed along the axis and at a corresponding angle relative to the instrument shaft longitudinal central axis. Fig. 5 illustrates this bending action. The bending at the proximal bendable member 18 is controlled by the surgeon from 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. 5, an axis U corresponding to the instrument shaft longitudinal axis is shown in fig. 5. Reference is also made to the proximal bend angle B1 between axes P and U and the corresponding distal bend angle B2 between axes U and T.
Thus, the control at the handle is used to bend the instrument at the proximal motion member, which in turn controls the positioning of the distal motion member and the tool. The "position" of the tool is primarily determined by this bending or motion effect and may be considered as the coordinate position at the distal end of the distal motion member. Indeed, one may consider coordinate axes at both the proximal and distal motion members and at the tip of the instrument. The positioning is three-dimensional. Of course, instrument positioning is also controlled to some extent by the surgeon's ability to pivot the instrument at the incision point. On the other hand, the "orientation" of the tool relates to the rotational positioning of the tool away from the proximal rotational control member about the distal tip or tool axis T as shown.
In the figures, a series of jaws are shown, but 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, displays, fluid delivery devices, syringes, and the like. The tool may include various articulating tools, such as: jaws, scissors, graspers, needle holders, mini dissectors, needle applicators, button tackers, suction irrigation tools, and clip applicators. Furthermore, the tool may comprise a non-articulated tool, such as: cutting blades, probes, irrigators, catheters, or aspiration orifices.
The surgical instrument illustrated in fig. 1 shows a preferred embodiment of a surgical instrument 10 for use in accordance with the present invention and may be inserted through a cannula at an incision site through the skin of a patient. Many of the components shown herein, such as the instrument shaft 14, end effector 16, distal bending member 20, and proximal bending member 18, may interact with and 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, the entire contents of which are hereby incorporated by reference. Various other components shown herein, particularly the components at the handle end of the instrument shown in fig. 15 herein, 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. The following applications, all of which are assigned to the present assignee, are also incorporated herein by reference in their entirety: U.S. application serial No. 10/822,081 filed on 12.4.2004; U.S. application serial No. 11/242,642 filed on 3.10.2005; U.S. application serial No. 11/302,654 filed on 12/14/2005; and U.S. application serial No. 605,694 filed on 28.11.2006.
As shown in fig. 2-9, control between the proximal and distal bendable members 18, 20 is provided by means of a bend control cable 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. As shown, for example, in fig. 4 and 5, the bend control cables 100 extend through the instrument shaft 14 and through the proximal and distal bendable members. The bend control cables 100 are preferably constrained along substantially their entire length to prevent them from buckling when actuated.
The instrument shown in fig. 1 is in-line. However, the principles of the present invention may also be applied to other forms of handles, such as a pistol grip handle as shown in fig. 15 herein, for example. In fig. 1, a jaw gripping means or actuating means is also shown, which is mainly constituted by a rod 22. The lever 22 controls the main tool actuation cable 38. For further details of the various tool actuation mechanisms, please see any of the above co-pending applications.
The instrument shaft 14 includes an outer shaft tube 32 that may be constructed of a lightweight metal material or may be constructed of plastic. Reference is made to fig. 3, which is a cross-sectional view taken through the instrument shaft at the proximal end of the instrument shaft, along line 3-3 of fig. 2. As shown in fig. 2, the proximal end of tube 32 is received by adapter 26. The distal end of the tube 32 is fixed to the distal bendable member 20. A support tube 34, preferably made of plastic, is disposed 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 pawl actuation cable 38 extends within the support tube 34.
In the illustrated instrument, the handle end of the instrument may be inclined in any direction as 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 by bending the control cable 100. As previously mentioned, the opposite direction of bending can be utilized by rotating or twisting the control cable 180 degrees from one end to the other. Reference is made to the schematic perspective view of fig. 15. For an illustration of a cable scheme that can be used in the illustrated instrument, see fig. 15 of co-pending application serial No. 11/649,352 filed on 2.1.2007, which application is incorporated by reference herein in its entirety.
In the first embodiment described herein, the handle 12 has an in-line form, with an associated actuation lever 22 supported by the handle 12. A tool actuation lever 22 is shown in fig. 1 and is pivotally attached to the bottom of the handle. The lever 22 actuates a slide (not shown) that controls a tool actuation cable 38, the 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 rod control the force applied at the jaws. For more details on the handle and slider mechanism, see application serial No. 11/185,911, supra, filed on 7/20/2005.
Reference is now made to fig. 2-4. In this instrument, the distal bendable member 20 is shown without any shield to show some details of the distal bendable member 20. The distal bendable member is comprised of spaced apart discs defining spaced apart slots 112 therebetween. The ribs 111 may be connected between adjacent disks in a manner similar to that described in the above-mentioned U.S. application serial No. 11/185,911. For more details on the tool end of the instrument, see application serial No. 11/528,134, supra, filed on 27/9/2006.
The proximal bendable member 18, like the distal bendable member 20, may also be constructed as a unitary or one-piece slotted structure including a series of flexible disks 130 defining slots 132 therebetween. "monolithic" or "integral" can be defined as a structure that: that is, the structure is used as a single member, and does not require assembly of multiple parts. The ribs (not shown) involved may extend between adjacent discs 130. The two bendable members preferably have the form of ribs: that is, the ribs are arranged preferably 60 degrees apart from one rib to an adjacent rib. This has been found to provide improved bending action. It was found that the bending can be improved by providing the ribs with a space between the ribs of less than 90 degrees. The ribs may be arranged with a spacing of about 35 degrees to about 75 degrees from one rib to an adjacent rib. By using a spacing of less than 90 degrees, the ribs can be more evenly distributed. Thus, the bending motion is more uniform in any orientation. In the present invention, the two bendable members may be made of a highly elastic polymer, such as PEBAX (polyether Block amide), but may be made of other elastic and resilient materials.
The rotation button 24 is provided with a proximal hub 25, said proximal hub 25 supporting the proximal end of the proximal bendable member 18. Fig. 2 shows the cable 100 extending through the proximal bendable member 18 and the hub 25. Rather than terminating at the proximal bendable member or hub, the bend control cables terminate at a clutch member, also referred to herein as a follower mechanism 140.
According to the invention, a preferred cable solution uses a bend control cable that is relatively stiff and yet bendable. Stiffer cables allow not only "pull" but also "push" movement of them. This enables better control via the cable when providing control-not only when "pulling" the cable but also when "pushing" the cable. This allows for more uniform control through 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 channel to prevent buckling when pushed. This may be facilitated by the shaft filler described in co-pending application serial No. 11/649,352 filed on day 1, 2, 2007, among other applications. In particular, to allow a "pushing" action, the cables are configured so that they do not deform inside the instrument itself.
As indicated previously, one of the primary features of the present invention is the ability to reposition the control handle during a medical procedure. At this point, there are at least two different ways in which this repositioning can be made. In a simpler embodiment, as shown in fig. 8 and 9, a clutch or follower member is provided that can be actuated at the proximal end of the instrument to either couple the proximal and distal members for consistent operation or to allow free movement of the handle for repositioning without substantially affecting the distal member. Another embodiment of the present invention, as shown in fig. 1-7, uses the same clutch or follower member, but adds a gripping member for the cable actuation means to maintain a specific position at the distal end of the instrument while performing proximal repositioning.
Follower 140 is shown in fig. 2-7. The follower or clutch mechanism 140 includes, among other things, an anchor ring 142 that provides the primary support for the bend control cable 100 and a split ball 125 that supports a guide sleeve 148. Wedge member 180 is actuated to lock or unlock split ball 125. Anchoring ring 142 includes diametrically disposed pins 172 that are received in elongated slots of opposed rearwardly extending fingers 176. The fingers 176 extend from the rotary button hub 25. The individual cables 100 are attached to the anchoring ring by means of end lugs 102. A spring or resilient pad 104 is preferably disposed between the lug 102 and the anchor ring 142. Each cable 100 is also preferably supported in a stiffer tube 105 so that it is suitably constrained and does not buckle when actuated.
The clutch mechanism 140 is adapted to fixedly terminate the bend control cable 100 at the anchor ring 142, either in a locked position, in which the guide sleeve is free to pivot or rotate on the split ball to enable repositioning of the handle in a new position, or in what is referred to as an unlocked position. From that new position, the clutch mechanism is then engaged again to enable control of the distal end of the instrument from the proximal handle. In other words, when re-engaged, guide sleeve 148 is locked to split ball member 125.
When the instrument is shown in this embodiment in a straight in-line position as shown in fig. 4, then the clutch mechanism 140, and in particular the anchor ring 142, extends substantially transverse to the central axis P. When the handle 120 is flexed, such as in the position shown in fig. 5, it is noted that the follower or clutch mechanism 140 maintains its transverse position relative to the longitudinal axis P. When the clutch mechanism 140 is to be locked, then the wedge member 180 engages the split balls 125, forcing the balls against the guide sleeves, which locks the position of the anchoring ring 142 and thus also the position of the bend control cable 100. When the clutch mechanism 140 is to be unlocked, then the wedge member 180 disengages from the split ball 125, which enables repositioning of the control cable 100 because the ball member no longer engages the guide sleeve. In both the locked and unlocked positions of mechanism 140, anchor ring 142 is permitted to rotate relative to the guide sleeve in response to rotation of button 24.
The clutch or locking mechanism 140 includes a retaining ring 149 in addition to the anchor ring 142 and the guide sleeve 148. A set screw or the like may be used to secure the guide sleeve 148 and retaining ring 149 together about the spherical ball 125 as shown in fig. 2. The ball 125 is also supported at its center by means of a sleeve 152 which may have a flange at one end adjacent to the wall 151 and a fastening nut or flange at the opposite end. Wedge member 180 is adapted to slide over sleeve 152 into split 147 of spherical split ball 125. The cross-sectional view of fig. 2 shows the ball 125 with its split 147. Figure 2 also shows a wedge member 180.
The tapered wedge 180 may be moved by means of a button arrangement including a lock button 155. The button can be considered to have opposite ends 155A and 155B. This locks the clutch mechanism of the instrument when the button end 155B is moved in the direction of arrow 155C (see FIG. 7). Conversely, when the button end 155A is pressed toward the handle housing in the direction of arrow 155D (see fig. 6), this releases the clutch mechanism. The tapered wedge member 180 is moved by means of the wedge 154 supported by the button 155. For additional details of a mechanism similar to the clutch mechanism 140, see FIGS. 9-12 of application Ser. No. 11/523,103, filed on 9/19/2006, which is incorporated herein by reference.
The first embodiment shown in fig. 1-7 also includes means for clamping the bend control cables so that the distal instrument position can be maintained while repositioning the proximal instrument position. In this regard, it is worth noting that the second embodiment shown in fig. 8 and 9 herein does not use a clamping device, but rather only a proximal repositioning mechanism. The clamping device 133 shown comprises a clamping ring 134, a connecting rod 135, an annular wedge 136 and an elastic conical ring 137. Fig. 2 shows the clamping member in its non-clamped state. Fig. 3 is a cross-sectional view through the clamping device 133 showing further details of the clamping member. In this embodiment, the clamping member is disposed at the distal end of the adapter 26 or at the proximal end of the instrument shaft. This is a convenient location for the user of the instrument to actuate, but may be located elsewhere relative to the instrument shaft.
In the position of FIG. 2, the clamping mechanism is disengaged and the clamping ring 134 is disposed to the left of the slot 138. At that position, the wedge 136 is disengaged from the cable 100, and the cable is free to move in order to control instrument bending. On the other hand, FIG. 5 shows that the clamping ring 134 has been moved to the locked position, to the right of the groove 138. This action clamps the cable 100 between the wedge 136 and the elastic cone 137. This clamping action maintains the position at the distal end of the instrument (end effector) at the position when the clamping member is locked. Once this clamping is started, the handle is free to be repositioned (the clutch mechanism is released and then engaged at a new position).
Reference is now made to the schematic illustrations of the manner in which the clutch control of the present invention operates in FIGS. 2-7. Fig. 2 shows the clutch mechanism unlocked, wherein the wedge member 180 is not engaged with the split ball 125. Fig. 2 also shows the clamping member in an unclamped position. Fig. 4 shows the instrument in the in-line position with the clutch mechanism 140 locked and the clamping mechanism in its non-clamping position. In the position of fig. 4, the instrument is arranged such that it can easily bend in any direction. When the clutch mechanism is locked, the bend control cable is substantially in an operable state.
FIG. 5 shows the cable and clutch arrangement as the instrument handle is moved to bend the proximal bendable member which in turn bends the distal bendable member and the tool. The handle is bent at an angle B1 and the tool is correspondingly bent at the angle B2 shown. In fig. 5, with the clutch mechanism still locked, there is no movement of the guide sleeve 148 relative to the ball 125, and thus the anchor ring 142 is maintained in its lateral position relative to the handle axis P. Fig. 5 shows the proximal bendable member 18 bent to cause a corresponding bending of the distal bendable member 20. In fig. 5, the clamping member 133 is then locked, thereby obstructing the bend control cables. This action holds the distal end of the instrument in the position shown in fig. 5 whatever happens at the proximal end of the instrument. Fig. 5 shows the clutch mechanism still locked.
The present fig. 6 illustrates the next possible step in the operation of the instrument in which the clamping member 133 remains locked to maintain the distal position while the proximal clutch mechanism has been unlocked or released to allow the instrument handle to be repositioned to the straight position shown in fig. 6. Thus, in fig. 6, the distal bend (B2) is maintained even though the proximal handle position has been repositioned to a straight position. It is also worth noting that in the position of fig. 6, the repositioning causes the clutch mechanism to tilt relative to the longitudinal axis of the handle to compensate for the change in position to the flat position. Although a straight position has been shown here, it will be appreciated that the handle and proximal bendable member may be repositioned to virtually any desired position before the clutch mechanism is engaged again.
After the handle has been repositioned, the proximal end of the instrument is then engaged again. In other words, the clutch mechanism 140 starts to engage again at the position of fig. 6. This is controlled by a button or switch 155 in its locked position shown in fig. 7. In addition, FIG. 7 shows the handle 12 and the proximal bendable member 18 moved downward to further position the distal bendable member 20 and the end effector 16. As can be noted from fig. 7, this action further deflects the end effector 16 at a greater angle B3. This allows the surgeon greater control over the distal portion of the instrument by selectively repositioning the handle while maintaining the distal portion of the instrument. In fig. 7, it is noted that before the control is performed, the clamping member is released by having the clamping ring 134 already moved distally, as shown in fig. 7.
With respect to another embodiment of the present invention, reference is now made to fig. 8 and 9, which is substantially the same as that shown in the first embodiment already described herein, except that only the clutch mechanism 140 is used, without the clamping mechanism. In fig. 8 and 9, the use cases of the same reference numerals are the same as those in the first embodiment as appropriate. In this embodiment of the invention, the proximal end of the instrument can be repositioned at virtually any time during use of the instrument, but specifically starting from an initial position such as the position of fig. 8. Fig. 8 shows the instrument in the in-line position with the clutch mechanism 140 disengaged. For example, from that position, the handle 12 can be moved downwardly to the position of fig. 9. Because the clutch mechanism is initially released, the handle can be moved without any substantial movement of the distal end of the instrument. Fig. 9 shows the handle bent downward but without the distal end bent. Fig. 9 also shows the clutch mechanism 140 subsequently engaged or locked to enable the onset of bend control. Starting from the position of fig. 9, the surgeon is able to move the handle in any direction, including a full 360 degree motion.
Fig. 10 and 11 show yet another embodiment of the present invention that includes both a clamping mechanism for restraining the cable and a clutch mechanism. In the embodiment shown in fig. 10 and 11, some of the same reference numerals are used to identify similar components to those described in the previous embodiments already described herein. Thus, fig. 10 and 11 illustrate a portion of the handle 12, a portion of the instrument shaft 14, the proximal bendable member 18, the rotation button 24, and the adapter 26. The clamping member 133 depicted in fig. 10 and 11 is substantially the same as the clamping member depicted in fig. 1-3. Thus, the clamping members comprise a clamping ring 134, a connecting rod 135, an annular wedge 136 and an elastic conical ring 137. The components of the clamping member are disposed at substantially the same positions as shown in the first embodiment shown in cross-section in fig. 2. In both cross-sectional views of fig. 10 and 11, the clutch mechanism is different from and actuated in a slightly different manner than the clutch mechanism described in the previous embodiment. This actuation is made by means of moving the rotary button 24 axially with respect to the handle, for example between the two positions shown in fig. 10 and 11, respectively.
In the embodiment of fig. 10 and 11, the follower or clutch mechanism 240 includes, among other things, an anchor ring 242 that provides the primary support for the bend control cable 200 and a split ball 225 that supports a guide sleeve 248. The split ball 225 is fixedly secured to the rotary button 24 and moves with axial displacement of the rotary button 24. The wedge member 280 is supported from the handle wall 281 and is capable of engaging and disengaging with the split ball 225. Wedge member 280 is fixed in position as the split balls are translated toward wedge member 280 and away from wedge member 280 to provide respective locking and unlocking of clutch mechanism 240. The anchoring ring 242 includes diametrically disposed pins 272 that are received in elongated slots of opposed rearwardly extending fingers 276. Fingers 276 extend from the rotary button hub.
The individual cables 200 are attached to the anchor ring 242 by means of the end lugs 202. A spring or resilient pad 204 is preferably disposed between the lug 202 and the anchor ring 242. Each cable 200 is also preferably supported in a relatively stiff tube (not shown in fig. 10 and 11) so that it is suitably restrained and does not buckle when the cable is actuated. 4 control cables may be used, or a fewer or greater number of control cables may be used.
In the embodiment of fig. 10 and 11, the clutch mechanism 240 is adapted to either in a locked position, in which the bend control cable 200 is fixedly terminated at the anchor ring 242, or in a so-called unlocked or released position, in which the guide sleeve is free to pivot or rotate on the split ball to enable repositioning of the handle in a new position. From that new position, the clutch mechanism is then engaged again to enable control of the distal end of the instrument from the proximal handle. In fig. 10, the cross-sectional view shows the clutch mechanism in its clutched or locked position. The rotary button 24 has been moved to the right for engagement between the split ball 225 and the wedge member 280. This causes the split balls to expand and contact the guide sleeve 248, thus remaining in a fixed position between the guide sleeve and the split balls.
On the other hand, the cross-sectional view of FIG. 11 shows the rotation button located at a more distal position, thus releasing the engagement between the wedge member 280 and the split ball 225, with the guide sleeve free to pivot or rotate on the split ball to enable repositioning of the handle. The same sequence previously described in connection with fig. 1-7 may also be applied to the embodiment of fig. 10 and 11, whereby the clamping members can be engaged to maintain a preselected position at the distal end of the instrument while the clutch mechanism is either locked or unlocked to enable either further control of the distal end of the instrument or repositioning of the handle. In the embodiment shown in fig. 10 and 11, the anchoring ring 242 is rotatable relative to the guide sleeve 248, for example upon rotation of the rotary button 24. In the locked position of the clutch mechanism 240, the wedge member 280 forces the split balls apart, thus substantially maintaining the guide sleeve in a fixed position on the split balls 225. On the other hand, when the rotary button 24 is moved to the position shown in FIG. 11, the split balls are no longer expanded and the guide sleeve is free to move over the split balls 225.
Reference is now made to a further embodiment of the invention illustrated in fig. 12-14. Fig. 12 is a partial cross-sectional view showing the instrument. Fig. 14 is an exploded perspective view of the components of the instrument. The instrument shown in fig. 12-14 also includes a clutch mechanism and a clamping mechanism and means for locking a particular position between the handle and the tool. The instrument shown in the cross-sectional view of fig. 12 includes a separate locking mechanism for locking a particular position of the instrument. For instrument configurations including the same components as shown in fig. 12-14, see co-pending application serial No. 11/605,694 filed on 11/28/2006, which is incorporated herein by reference.
Fig. 12 is a partial cross-sectional view of the instrument of this embodiment, showing only a portion of the handle 12 and instrument shaft 14. FIG. 12 also shows the distal bendable member 20, which may be a unitary construction, and the end effector 16. In FIG. 12, a cable 800 is shown extending through the instrument shaft and coupled to the end effector 16. Only the configuration of the handle at the junction with the proximal bendable member 818 is shown in partial view. The handle includes a lever (not shown) for actuating a tool actuation cable that extends to the end effector.
In the embodiment of FIG. 12, it is the tilting of the handle relative to the adapter 826 that controls the distal bending at the distal bendable member 20. Alternatively, one may consider the inclination of the shaft relative to the handle. A rotation button 824 is integrally formed with the adapter 826 and provides for rotation of the instrument shaft, particularly of the outer tube 832 of the instrument shaft relative to the inner tube of the instrument shaft. Rotation of the outer tube 832 of the instrument shaft rotates the distal bendable member and the end effector supported at the distal end of the distal bendable member. This provides rotation of the instrument tip about a distal tip axis, such as axis P in fig. 12.
Outer shaft tube 832 is secured within adapter 826. The inner tube 834 is supported relative to the outer tube 832. The cross-sectional views of fig. 12 and 13 show four bend control cables 800. A spacer (not shown) with a guide slot may also be provided within the instrument shaft to accommodate the cable 800. Although four control cables 800 are shown in the cross-sectional view of fig. 13, a fewer or greater number of cables may be provided in other embodiments.
The proximal end 836 of the inner tube 834 supports the ball 815. The ball 815 is fixedly mounted on the end of the inner member that does not rotate. The tool actuation cable passes through the ball 815. To this end, the ball 815 is provided with a slightly conical cavity 817.
In the embodiment of fig. 12-14, three-dimensional tilting of the end effector is performed by a handle having the ability to similarly bend or tilt in three dimensions relative to the adapter 826. To this end, the handle may be provided in two halves defining a spherical socket 825 therebetween. The exploded perspective view of fig. 14 shows the spherical ball 815 and the receiving spherical socket 825 as part of the handle 12. The ball 815 is provided with a diametrically disposed pin 827 that is received in a diametrically disposed slot 828 in the handle of the spherical socket 825. The pin and slot arrangement allows the handle to move in three dimensions relative to the ball 815. The pin 827 can shift in the slot 828 as the handle moves in the plane of the paper of fig. 12. Also, the handle may pivot relative to the pin 827 as the handle moves in and out of the plane of the paper in FIG. 12. This provides three-dimensional positioning.
Fig. 12 also shows a rotating anchor ring 840, which rotating anchor ring 840 is supported relative to the handle and carries the very proximal end of each cable 800. To this end, anchoring ring 840 includes four holes disposed 90 degrees apart from each other and receiving the proximal end (lugs 841) of each cable 800. A spring or resilient member, indicated at 842, may be disposed between each cable termination and the rotating anchor ring 840. In the position shown in fig. 12, it is noted that the handle is tilted downward. This tilting of the handle causes a corresponding upward movement of the end effector via the distal bendable member 20 as long as the cable 800 is not twisted within the instrument shaft. The anchoring ring 840 is free to rotate relative to the guide sleeve 880 in order to rotate the distal tip of the instrument.
As previously noted, anchoring ring 840 represents a means for holding the very proximal end of cable 800. Also, the rotating anchor ring 840 is an interface between the rotating button 824 and the handle. For this purpose, a diametrically arranged pin 849 is provided on the ring 840, said pin 849 being received in an arcuate groove 850 on the rotary button 824. The pin and slot arrangement enables the rotation button to rotate to in turn rotate the outer tube of the instrument shaft and the end effector. When the rotation knob 824 rotates the end effector, the pin 849 moves in the slot 850 to enable such rotational movement, regardless of the position of the handle. With the additional pin and slot arrangement 827, 828, the pin 849 and slot 850 are able to rotate the rotation button 824 regardless of the position of the handle relative to the instrument shaft.
The cross-sectional view of FIG. 12 also shows two independent button controls at the handle. One of these controls is used to control the locking of the instrument shaft in a particular bending state. This is controlled by a button device identified as a. Another button device, identified as B in the cross-sectional view of fig. 12, controls the clutch according to this embodiment which enables repositioning of the handle.
In fig. 12, the locking mechanism associated with the button device a includes a sleeve 852 supporting a flange 853 at one end and a cup 854 at the other end. The cup 854 is supported to slide toward and away from the ball 815. The sleeve 852 is adapted to translate linearly toward and away from the ball 815. In one position, the sleeve is disposed away from the ball and the cup 854 is moved in the opposite direction into contact with the ball to lock the position of the handle relative to the ball 815. Once in this locked position, the entire instrument is locked in place by the proximal and distal bendable members, except that the tip may be rotated via the rotation button 824.
The translation of the sleeve 852 is controlled by the wedge 856. The wedge 856 has a flat surface that abuts the flange 853 and has a tapered surface that engages the tapered wall of the handle. The wedge 856 also includes an elongated slot that provides sufficient clearance for the tool actuation cable to not come into contact with a shroud associated with the tool actuation cable as the wedge member 856 moves between the locked and unlocked positions.
The wedge member 856 is controlled by means of a pair of buttons. This includes a lock button 860 supported at the end of the shaft 861. On the opposite side of the wedge member 856 a release button 862 is supported from the wedge member by means of a shaft 863. When the lock button 860 is pushed inward toward the handle, this causes the wedge member 856 to move against the tapered surface, thereby longitudinally moving the sleeve 852 such that the cup 854 exerts a tightening pressure or force on the ball 815. When this occurs, the handle remains in a fixed position relative to the ball 815. In other words, regardless of the position of the instrument, at any time the button 860 is depressed, the instrument remains in that position with the end effector in a particular relative position. The locking member may be released by pushing on the release button 862, thereby causing the wedge member 856 to move longitudinally in the opposite direction. This releases the tension on the sleeve 852 so that the cup 854 is no longer in intimate contact with the ball 815. This enables the handle to be moved to any three-dimensional position relative to the adapter 826. Biasing means or detent means may be used in connection with the locking mechanism.
Another button arrangement B shown in fig. 12 is used for repositioning of the control handle. This action controls the engagement between the guide sleeve 880 supporting the anchoring ring 840 and the outer surface 881 forming the handle end of the socket for the ball 815. This outer surface 881 supports four arcuate panels 882 in receiving recesses on the surface 881. The plate 882 is adapted to move outwardly in the direction of arrow 883 to brace against the guide sleeve 880. In the locked position of the clutch mechanism, the plates bear against the guide sleeve 880. In the release position of the clutch mechanism, the plate 882 is released and no longer provides any bearing force against the guide sleeve 880.
The plates 882 are actuated by means of four conical wires 885, one end of which 885 extends below the respective plate 882 and the opposite end is held at the button device B, more particularly at the bottom 887. The bottom portion 887 is supported by an end pin 888 extending through a chute 889 of the frame 890. As shown in the exploded perspective view of fig. 14, there is a push button 892, which is part of a push button arrangement B that can be pushed downward to retract the tapered wire 885. At the other end of the button device B there is a button 894, said button 894 being connected to the frame 890. When the button 894 is pushed upwardly in fig. 14, this forces the tapered wire forward into engagement with the corresponding plate 882 to lock the clutch mechanism. When the push button 892 is pushed downward in fig. 14, this retracts the tapered wires out of engagement with the respective plate 882 to unlock or release the clutch mechanism.
Reference is now made to a further embodiment of the present invention illustrated in fig. 15, wherein the clutching concept is applied to a pistol-grip type instrument, such as the type described in the above-identified co-pending application serial No. 11/649,352. In this embodiment, the locking mechanism or angle locking means 440 used comprises a ball and socket arrangement disposed substantially above the proximal bendable member 418 and following the bending at the proximal bendable member. The locking mechanism has a locked position and an unlocked position, is disposed adjacent the proximal movable or bendable member and is manually controlled to fix the position of the proximal bendable member relative to the handle in its locked position. The locking mechanism includes a ball member and a compressible hub defining a ball and socket member. The hub may be a split hub and the locking mechanism is shown to include a locking bar 421 and a gripping ring 420 disposed around the split hub, the locking bar 421 being mounted on the gripping ring to close the gripping ring around the hub to lock the hub against the spherical ball member 422. The grip ring 420 interlocks with the hub, but is able to rotate relative to the hub when in the unlocked position.
The "ball" portion is formed substantially by the ball member 422, while the "socket" portion is formed substantially by an extension of the handle. The locking mechanism locks the proximal bendable member in the desired position and by doing so also locks the position of the distal bendable member and the tool. The proximal bendable member 418, while enclosed by a ball and socket arrangement, still allows the instrument shaft 414 and proximal bendable member 418 to rotate freely (rotate the button 424) with the cable 400, while also allowing the axis of the instrument shaft to be angled relative to the axis of the handle in the free or alternately locked mode.
For this purpose, reference is made to the ball member 422 shown in fig. 12. The ball member 422 includes a distal neck 406, the distal neck 406 abutting a partially spherical ball end having a spherical outer surface 404. The neck portion 406 is disposed substantially over the adapter 426 and the tapered portion 419 of the proximal bendable member 418, while the ball portion is disposed substantially over a substantial portion of the proximal bendable member 418. The ball member 422 is adapted to sit within a socket formed in the handle in the form of the hub 402, and the hub 402 can be collapsed about the ball member 422 by compressing the clamping ring 420 in a radial direction. For further details of this locking configuration, see additional details found in co-pending application serial No. 11/649,352, which is incorporated herein by reference.
The rotation button 424 is provided with a proximal hub 425 that supports the proximal end of the proximal bendable member 418. Fig. 15 shows the cable 400 extending through the proximal bendable member 418 and the hub 425. Rather than having the bend control cables terminate at the proximal bendable member or hub, these cables terminate at clutch members, also referred to herein as follower mechanisms 540.
The follower or clutch mechanism 540 includes, among other things, an anchor ring 542 that provides the primary support for the bend control cable 400 and a split ball 525 that supports a guide sleeve 548. Wedge member 580 is actuated to lock or unlock split ball 525. The individual cables 400 are attached to the anchoring ring by means of end lugs 502. A spring or elastomeric pad 504 is preferably disposed between the lug 502 and the anchor ring 542. Each cable 400 is also preferably supported in a stiffer tube 505 so that it is suitably constrained and does not buckle when actuated. The stiffer tube 505 shown in fig. 15 is disposed between the hub 425 and the anchoring ring 542.
The clutch mechanism 540 is adapted to fixedly terminate the bend control cable 400 at the anchor ring 542, either in a locked position, in which the guide sleeve is free to pivot or rotate on the split ball to enable repositioning of the handle in a new position, or in what may be referred to as an unlocked position. From that new position, the clutch mechanism is then engaged again to enable control of the distal end of the instrument from the proximal handle. In other words, when re-engaged, guide sleeve 548 is locked to split ball member 525. In both the locked and unlocked positions of mechanism 540, anchor ring 542 is permitted to rotate relative to the guide sleeve in response to rotation of button 424. When clutch mechanism 540 is to be locked, then wedge member 580 engages split ball 525, forcing the ball against the guide sleeve, which locks the position of anchor ring 542 and thus also the position of bend control cable 400. When the clutch mechanism 540 is to be unlocked, then the wedge member 580 disengages from the split balls 525, which enables repositioning of the handle 412 and the control cable 400 because the ball member no longer engages the guide sleeve. The mechanism shown in fig. 15 may be substantially the same as the mechanism shown in fig. 2 herein.
The tapered wedge 580 may be moved by means of a button arrangement (not shown in fig. 15) as the button arrangement depicted in fig. 2 herein. The button may be considered to have opposite ends and be movable in opposite directions to lock or unlock the clutch mechanism. The tapered wedge member 580 is moved by means of a wedge 554 supported by the button arrangement.
The embodiment shown in FIG. 15 also includes means for clamping the bend control cables so that the distal instrument position can be maintained while repositioning the proximal instrument position. The illustrated clamping device 133 includes a clamping ring 134, a connecting rod 135, an annular wedge 136, and a resilient tapered ring 137, substantially as previously shown and discussed in fig. 2. Fig. 15 shows the clamping member in its non-clamped state. In this embodiment, the clamping member is disposed at the distal end of the adapter 426 or at the proximal end of the instrument shaft. This is a convenient location for the user of the instrument to actuate, but may be located elsewhere relative to the instrument shaft.
In the position of FIG. 15, the clamping mechanism is disengaged and the clamping ring 134 is disposed to the left of the slot. At that position, the wedge 136 is disengaged from the cable 400, and the cable is free to move in order to control instrument bending. This action clamps the cable 400 between the wedge 136 and the resilient cone 137 when the clamping ring 134 is moved to the locked position-to the right of the slot. This clamping action maintains the position at the distal end of the instrument (end effector) at the position when the clamping member is locked. Once this clamping is started, the handle is free to be repositioned (the clutch mechanism is released and then engaged at a new position).
Having now described a limited number of embodiments of the present invention, it will now be appreciated by those of ordinary skill 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. For example, in another form of the invention, different forms of instrument tip rotation means, such as a sliding mechanism, may be used to control distal rotation about the tool tip axis. Even with such alternative arrangements, the instrument may still have an associated locking function in order to provide the locking function. Also, in the instruments described herein, the movable member is shown as a bendable portion, and more specifically, as a unitary bendable portion. However, the movable member may alternatively be other configurations including, but not limited to, an engageable disk, a bellows arrangement, a movable ring member or a ball and socket member. For other forms of bendable members, see co-pending application serial No. 11/505,003 filed on 16/8/2006 and No. 11/523,103 filed on 19/9/2006, both of which are hereby incorporated by reference in their entirety.