None.
The present invention relates to the field of surgical tools, and particularly to the design and manufacture of surgical retractor systems. Surgical retractor systems are used during surgery to bias and hold tissue in a desired position. As one example, some surgical procedures require anterior access to the spine, through the patient's abdomen. Tissue such as skin, muscle, fatty tissue and interior organs needs to be held retracted to the side so the surgeon can obtain better access to the vertebrae structures of primary interest.
Surgical retraction may be performed by one or more aides using handheld tools, with the most basic retractor apparatus being a tongue depressor. More commonly now in sophisticated operating rooms during abdominal or chest surgery, a surgical retractor system or assembly is used. The retractor assembly may, for instance, include a ring or support frame which is rigidly supported from the patient's bed above and around the surgical incision location, with a number of clamps and retractor blades to hold back tissue proximate to the surgical incision. Other retraction systems, such as those disclosed in U.S. Pat. Nos. 6,315,718, 6,368,271 and 6,659,944 to Sharratt, incorporated herein by reference, may not include a ring and/or may be directed at other types of surgery. Clamps may also be used to attach the ring or support frame to a support post and/or part of the bed frame.
In devising a proper clamping structure, the clamp should give the surgeon flexibility in quickly assembling the retraction system and in placement of the various retractors. (The term “surgeon” is used herein as including the person operating the clamp, who may or may not be the person performing the actual surgery.) Once the various retractors are in place and oriented and pulled as desired, the retraction system clamps should allow quick and easy tightening so the entire retraction system is maintained fixedly in place. Once tightened the retraction system should be unobtrusive so neither the tissue held retracted nor the retraction system interfere in any way with the surgeon or the surgical procedure. After surgery is completed (or perhaps once or more during surgery), the retraction system should quickly loosen and/or disassemble so as relax the retracted tissue and minimize damage to the retracted tissue. Surgical retractor systems must be robust and strong, as even a slight possibility of failure during use is not tolerated. Surgical retractor assemblies should be readily reusable, including sterilizable, for use in multiple surgeries. Surgical retractor systems should maintain a relatively low cost. Improvements in surgical retractor clamps and systems can be made in keeping with these goals.
The present invention is a surgical clamp and clamping system having two clamp openings, one for a support frame and another for a retractor or tool shaft. Both of these openings permit transverse attachment. A handle tightens the clamp. The handle attaches to the clamp at a location lower than the shaft, while at the same time having a gripping portion which extends above the shaft axis. With this clamp and handle configuration, the clamp maintains a very low profile while still allowing easy access to the handle from above during the tightening and/or loosening motions. In one aspect, the handle maintains alignment with the shaft during pivoting of the shaft relative to the support frame, permitting a single handed “scissors action” tightening.
While the above-identified drawing figures set forth preferred embodiments, other embodiments of the present invention are also contemplated, some of which are noted in the discussion. In all cases, this disclosure presents the illustrated embodiments of the present invention by way of representation and not limitation. Numerous other minor modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of this invention.
As shown in
The clamp 22 of the present invention as shown in
The frame clamp 26 may be a fulcrum clamp as generally disclosed in U.S. Pat. No. 5,727,899 and in application Ser. No. 10/664,195 filed Sep. 17, 2003 and Ser. No. 11/330,625 filed Jan. 12, 2006, all incorporated by reference. The preferred fulcrum clamp 26 thus includes a fulcrum portion 30 extending between an upper leg portion 32 and a lower leg portion 34. The fulcrum portion 30 allows the size of the frame clamp opening 36 to change based upon biasing the upper leg portion 32 away from the lower leg portion 34. A wedge or cam 38 (shown in
A significant advantage of using a fulcrum clamp for the frame clamp 26 is that it includes a clamping opening 36 which is open from below. The clamping opening 36 therefore permits the frame clamp 26 to be placed on the retractor support frame 18 transversely, i.e., without requiring longitudinal threading of the clamp body onto the support frame 18 and without moving any other surgical equipment that has been previously disposed upon the retractor support frame 18. The frame clamp 26 may be lightly and quickly snapped onto the support frame 18 at any substantially straight location desired by the surgeon. The frame clamp opening 36 is sized to mate with the cross-sectional size and shape of the support frame 18, such as a ½″ diameter cylindrical shape. In the loosened position, the frame clamp 26 permits substantially unimpeded longitudinal movement of the clamp 22 on any linear portion of the support frame 18, as well as substantially free rotation of the clamp 22 about the support frame axis 40.
Another significant advantage of using a fulcrum clamp is that the clamping force is easily made to be self-sustaining by use of a wedge or cam member 38 placing equal and opposite forces on the upper and lower leg portions 32, 34. Once the frame clamp 26 is closed to a tightened position, it does not require further application of force or holding by the surgical staff to remain in the tightened position. The preferred frame clamp cam 38 includes two outer lobes 39 for pushing downward and a central lobe 41 for pushing upward so it can provide a balanced force and for ease of manufacture and assembly. Many other types of mechanical wedges could alternatively be used for providing and maintaining the clamping force.
A third significant advantage of using a fulcrum clamp is that the actuating mechanism can be positioned closely in to the support frame 18, and at the same elevation as the support frame 18. This is best shown with reference to
The shaft clamp 28 is preferably also open for side or top attachment of the retractor shaft 16, such as the side attachment clamp shown. As best shown in
The shaft clamp 28 is preferably activated by the same handle 24 as the frame clamp 26. To achieve the simultaneous tightening with a single handle 24, pivoting movement of the handle 24 not only causes the wedge 38 to increase separation between the upper and lower legs 32, 34, but also moves a pin 52 vertically upward to press the retractor shaft 16 against the top stanchion 44. The pin 52 translates or slides in a pin bore 54 in the bottom of the shaft clamp 28. The pin bore 54 intersects the shaft clamp opening 48, so the pin 52 can be biased against the outer profile of the shaft 16 by sliding the pin 52 in the pin bore 54.
A significant advantage of using a side snap clamp for the shaft clamp 28 is that it includes a clamping opening 48 which is open from above the support frame 18. The clamping opening 48 therefore permits the retractor shaft 16 to be placed into the side snap clamp 28 transversely, i.e., without requiring longitudinal threading of the shaft 16 through the shaft clamp opening 48. The handle 24 is preferably oriented to the side with a horizontal offset 53 providing a minimum clearance 55 (best shown in
In the preferred embodiment, the handle 24 includes a grasping portion 57 and an arm portion 59 extending from the cam 38. The grasping portion 57 is centered relative to the shaft axis 50, so biasing the handle 24 tighter or looser by the surgeon will result in no net rotational moment of the clamp 22 about the shaft axis 50. In the preferred embodiment as shown in
The shaft 16 may be lightly and quickly snapped into the shaft clamp 28 at any longitudinal location and angular orientation (i.e. either pivoted about the support frame 18 to a non-horizontal angle, or pivoted about a vertical axis 58 as described below) desired by the surgeon. The shaft clamp opening 48 is sized to mate with the cross-sectional size and shape of the shaft 16, such as a ⅜″ diameter cylindrical shape. In the loosened position, the shaft clamp 28 permits substantially unimpeded longitudinal movement of the shaft 16 in the shaft clamp opening 48, as well as substantially free rotation of the shaft 16 about its axis 50 in the shaft clamp opening 48.
The shaft clamp 28 is pivotable relative to the frame clamp 26 about the vertical axis 58. To achieve the pivoting feature, the shaft clamp 28 is attached to the frame clamp 26 through a rotatable attachment. After the clamp 22 is positioned on the support frame 18 and the shaft 16 is positioned in the shaft clamp 28 but before the handle 24 is moved from the loosened position to the tightened position, the shaft 16 is pivotable about the pivot axis 58. As shown in
As best shown in
In most surgical procedures and as depicted in the figures (particularly
As best shown in
The handle 24 is keyed to the shaft clamp 28 so the handle 24 moves with the shaft clamp 28 and controls the pivoting location of the shaft clamp 28 about the vertical axis 58. The preferred keying structure is through the tightening pin 52, best shown in
The preferred clamp 22 permits pivoting of the shaft 16 relative to the support frame 18 through angles θ1 and θ2 (best shown in
The clockwise pivoting angle θ2 is even greater, and in the preferred embodiment extends about 90° before the proximal end of the handle 24 (the end of the handle 24 beyond the cam 38) interferes with the frame clamp 26. If desired, the length of the proximal end of the handle 24 could be made shorter or the offset 63 increased slightly to permit an even greater clockwise pivoting angle θ2. With the full pivoting angle θ1+θ2 being greater than 180°, any desired angle of securement is possible. For instance, if the surgeon desires to secure the shaft 16 at a 60° counterclockwise angle to the frame 18, the handle 24 could be rotated 120° clockwise and the shaft could be snapped into the shaft clamp 28 in a “backwards” orientation, with the handle 24 tightening toward the surgical arena.
To provide the desired base position for the outer cam lobes 39, the bearing surface between the cam lobes 39 and the lower leg 34 of the frame clamp 26 is provided by a variable height assembly with an adjustable base height, which includes a C-bearing 68, a plunger base 74, a spring 84 and an adjustment plug 82. The plunger base 74 and C-bearing 68 ride on the spring 84, which maintains a loosened compressive force (typically only a few pounds) biasing the assembly upwards. Transverse insertion of a properly-sized retractor shaft 16 into the shaft clamp 28 moves the pin 52 slightly downward, which in turn moves the C-bearing 68 and plunger base 74 slightly downward, against this spring force. During tightening of the clamp 22, first the cam action absorbs the spring deflection until the spring 84 bottoms out. After the spring 84 bottoms out, the remainder of the cam action causes a force loop which: a) forces the pin 52 upward to clamp the shaft 16 against the top stanchion 44, transferring the cam force through the shaft 16 to the stanchion 42, which in turn b) forces the bottom flange 60 upward to clamp the shaft clamp 28 against rotation against the recess 62 of the upper leg portion 32, transferring the cam force to the upper leg portion 32, which in turn c) forces the frame clamp 26 closed by bending at the fulcrum portion 30, to clamp the frame 18 against the lower leg portion 34. The C-bearing 68 follows the outer cam lobes 39, in an arc relative to the yoke 66 and frame clamp 26, during the entire throw of the handle 24.
In the preferred embodiment, the yoke 66 and the C-bearing 68, which bear against the cam 38 during tightening and loosening of the clamp 22, are formed of a strong bearing-grade metal, such as NITRONIC 60 super alloy. The remaining components may be formed of an appropriately strong sterilizable metal, such as surgical stainless steel.
During assembly of the preferred clamp 22 as best understood with reference to
The plunger base 74 is positioned into the lower leg portion 34 from above the lower leg portion 34. The handle 24 is then assembled in place from the side. The handle 24 is first positioned in the C-bearing 68, and retained in position in the C-bearing 68 with two captivation pins 72. Side ears 77 on the cam 38 maintain the cam 38 centered side to side in the C-bearing 68. Once in position, the C-bearing 68 provides stops which limit the throw of the cam 38 in both loosening and tightening to the desired 95° throw angle φ. The keyed yoke 66 is placed over the central lobe 41 of the cam 38 as the handle 24 and C-bearing 68 are slid in from the side. Side ears 77 may include flats 75 so side ears 77 do not interfere with the upper arm 32 in the loosened position.
Assembly is completed by placing a spring 84 and screwing an adjustment plug 82 in from below to bias the plunger base 74 upward. Spring 84 preferably has a low spring constant (such as 24 pounds per inch), so it will be fully compressed with a relatively small compression force (such as 4 pounds). The elevation of the adjustment plug 82 is selected by screwing an appropriate amount to provide the desired loosened and tightened (with spring 84 fully compressed) spacing for the clamp 22. For instance, the elevation of the adjustment plug 82 may be set such that a throw force on the handle 24 of 20 pounds will complete the tightening action about an appropriately sized shaft 16 and frame 18. Once the desired elevation for the adjustment plug 82 is achieved, the adjustment plug 82 is set at this elevation by upsetting the threads of the adjustment plug 82 by using an orbital riveting machine through the holes in the bottom arm 34.
Because the final seated position of the adjustment plug 82 is not set until after all the component parts are fully manufactured and assembled, the tightening force on the handle 24 is not changed by differing dimensions of the component parts within tolerance. That is, all the clamps 22 manufactured can be set to have the same tightening force, even if, for instance, the cam 38 on one clamp 22 is a mil or two larger than the cam 38 of a different clamp 22. The spring 84 places a vertically oriented force on the assembly and, together with proper tightening of the adjustment plug 82, prevents any separation or rattling of parts which might otherwise occur if the dimensional tolerances on any of these parts are not strictly met.
The preferred clamp 22 accordingly permits a loosened attachment to both the support frame 18 and the retractor shaft 16 which has five degrees of freedom: the clamp 22 can be slid longitudinally on the support frame 18; the clamp 22 can be rotated about the longitudinal axis 40 of the support frame attachment portion; the shaft 16 can be pivoted about the vertical axis 58; the shaft 16 can be slid longitudinally in the shaft clamp 28; and the shaft 16 can be rotated about the longitudinal axis 50 of the shaft attachment portion. When the handle 24 is “thrown” or pivoted from the loosened position to its tightened position, all five of these degrees of freedom are secured. During tightening, both the shaft opening and the frame opening dimensions are slightly decreased to eliminate any rotation or translation of the shaft 16 and frame 18 relative to the clamp 22. At the same time, the frictional engagement of the mating frustroconical surfaces 60, 62 after tightening prevent further pivoting of the shaft clamp 28 relative to the frame clamp 26.
The linkage between the handle 24 and the frame clamp 26 and the shaft clamp 28 is fully operated between the fully loosened position and the fully tightened position by a pivoting of the handle 24 through a tightening throw range φ shown in
In the fully tightened position, the grasping portion 57 of the handle 24 extends at a slight angle α to the shaft axis 50. This grasping angle σ, though not critical, assists in application of a greater squeeze force by the surgeon's normal grip, and also assists in providing clearance for releasing the clamp 22. In the preferred embodiment, the tightened grasping angle σ is about 5°. The bottom side of the grasping portion 57 of the handle 24 provides a spacing 96 of about ¾ of an inch over the top 88 of the shaft 16 for loosening access to the handle 24.
At this size, amount of pivoting and location of the handle pivot axis 43, the grasping surface 57 of the handle 24 is 4 inches away from the bottom biasing surface 86 of the shaft 16 while in the loosened position, and is about ½ inch away from the bottom biasing surface 86 of the shaft 16 when in the tightened position. The handle/shaft combination thus act in conjunction to ergonomically fit the grasp of most surgeons' hands for a single handed, intuitive tightening operation. The surgeon is most commonly standing roughly in line and behind the retractor shaft 16. Just as when cutting a wide cloth a seamstress will lean over a flatly laid cloth and cut away from his or her body, so too the surgeon tightens the clamp 22 with a natural “cutting” orientation, fingers down and thumb up, similar to a handshake position. While the clamp 22 can be readily tightened with a wide variety of single handed orientations, the most common hand orientation naturally coincides with the most common clamp orientation and strongest grip orientation relative to the person tightening the clamp 22.
As best shown in
As commonly desired, the clamp 22 is capable of being used with a vertical plane containing the shaft axis 50 being oriented perpendicular to the support frame axis 40. For instance, with the shaft/handle of the clamp 22 as shown in the solid lined plan view of
Whether in the tightened position or in the loosened position, the grip portion 57 of the handle 24 always resides vertically above the shaft 16. The shaft 16 is accordingly always in place below the handle 24 for the surgeon's hand to provide equal and opposite squeeze forces on the clamp 22 and hold the clamp 22 from rotating about the support frame 18 during tightening. Orienting the grip portion 57 of the handle 24 and the shaft 16 always in alignment is particularly important when the shaft 16 is at a non-perpendicular angle to the support frame 18, so the tightening forces can be carefully and easily controlled, via single-handed operation, without causing the frame clamp 26 to twist off the support frame 18. To provide this desired orientation of the grip portion 57 of the handle 24, the arm portion 59 of the handle 24 has a vertical S-curve offset 90 (shown in
The “over the top and downward” throw of the handle 24 of the preferred clamp 22 assists in avoiding any interference between the handle 24 and the patient's body or garments. Even if the support frame 18 is positioned very close or in contact with a patient's body or garments, the handle 24 will be accessible from above for its complete throw without interference in any way from the support frame 18 or the patient. In the loosened position (shown in
In the tightened position of the preferred clamp 22 with the most common orientation of the handle/shaft (in the six o'clock position shown in solid lines in
a) the distal end of the handle 24 has a tightened elevation 92 over the shaft 16 of only about 1 inch, and this highest elevation is spaced distally outward from the frame by a spacing 100 of about 4 inches;
b) the stanchion head 42 projects an elevation 94 of less than ¼ of an inch over the shaft 16, such as a profile elevation 94 of about 0.1 inches; and
c) the bottom surface 86 of the shaft 16 is a distance 98 of only about ¾ of an inch over the support frame 18.
With this configuration, the tightened clamp 22 virtually never interferes with the surgeon's line of sight or access to the surgical arena.
Thus it can be seen that the location and orientation of the handle 24 relative to the frame clamp 26 and relative to the shaft clamp 28 provide many advantages during the surgical procedure which are not provided by prior art clamps. While many linkage mechanisms can be used to translate tightening and loosening forces between the handle 24 and the frame clamp 26 and shaft clamp 28, the preferred linkage is cost effective, simple to manufacture and provides a very robust and easy to use clamp in an elegant design. The preferred linkage also uses the same cam 38 to transmit both the tightening force and a pivoting moment about axis 58 which keeps the handle 24 aligned with the shaft 16.
Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention. For instance, while the preferred embodiment includes two clamping members, certain aspects of the invention could be practiced with a single clamping member, such as integral with and/or permanently attached to either the support frame 18 or the retractor shaft 16. While a particular linkage is described which enables the handle 24 to simultaneously control both clamping members, it is recognized that many other types of linkages could be used while still obtaining the handle orientation benefits of the present invention.