This application claims the benefit, of U.S. Provisional Patent Application Ser. No. 60/691,141, filed Jun. 16, 2005, and U.S. Provisional Application Ser. No. ______ filed Dec. 2, 2005, the disclosures of which are incorporated herein by reference.
BACKGROUND OF THE INVENTION This invention relates generally to the field of devices utilized in surgery to retract and retain tissue, organs or the like to provide the surgeon with access or an unobstructed pathway to an organ, bone, tissue or point in the body. Such devices are typically referred to generically as retractors. More particularly, the invention relates to retractors utilized with minimally invasive surgical techniques, wherein minimally sized openings are created in the body rather than relatively large incisions. Tubular devices known as cannula retractors, or spreading retractors having finger-like extensions or blades, are inserted into the small opening and through or around the body tissues, muscles, tendons, ligaments, etc., thereby minimizing damage to the body. The surgeon then performs the necessary procedure through the retractor tube using specially designed tools and equipment.
A problem with known retractors used in minimally invasive surgery is that the distal end profile or configuration of the device is fixed. A typical tubular retractor has a circular or elliptical transverse cross-section with the distal end lying in the plane perpendicular or slanted relative to the longitudinal axis. Other tubular distractors may have non-planar ends of varying configurations, such as having a spatula-like extension. Spreading retractors likewise have varying end configurations. Because the distal end configurations of the devices are fixed, the devices often fail to prevent creep or herniation of tissue at or around the distal end of the device, and this tissue creep can interfere with the necessary physical or visual access. This is particularly true when the distal end of the retractor device is positioned adjacent or near a bone, such as a vertebra for example, that does not have a planar or smooth outer contour, or where the retractor device is disposed at a non-perpendicular angle to the bone. In these circumstances it often becomes necessary for the surgeon to cut away the interfering tissue, thereby creating additional tissue damage that needs to heal and increasing the possibility of detrimental results such as bleeding, increased pain, infection and the like.
One attempted solution that is found in certain retractors of the spreadable blade type is to provide shim members that are mounted in interior channels disposed in each of the blades. The shim can be extended beyond the distal end of the blade by sliding the shim relative to the blade. The shortcomings of this solution to the problem of tissue creep is that the location of the shims are determined by the location of the blades after they have been positioned and spread. Thus, the surgeon cannot address the problem of tissue creep that occurs between the blades.
The invention at hand addresses this tissue creep problem by providing a retractor device for minimally invasive surgery that incorporates extension members in the form of shields or barriers that are selectively attached at, adjacent or to the end of a tubular retractor, and to the ends or sides of blade-type spreadable retractors, so as to extend therefrom in order to fill any gaps between the distal end or side of the retractor and the bone, organ or other body component of concern, such that tissue is precluded from creeping or herniating into the gap. The extensions may be mounted to the retractor at any point about or adjacent the distal end utilizing various mechanical joining techniques, and the extensions may vary in shape, size, thickness and other characteristics. The extensions may be preformed with a fixed curvature so as to match the interior curvature of the retractor, or they may be composed of a flexible material such that they adapt to the interior curvature of the retractor upon affixation. The extensions may be provided with teeth, apertures, slits or the like to better prevent tissue creep.
Specialized applicator equipment or tools are preferably provided that allow the surgeon to grasp or secure a particular extension, to insert the extension into and down the retractor, and to affix the extension to the interior wall or distal end of the retractor. Such equipment may take the form of forceps that retain the extension member during insertion and placement within the tubular retractor or other retractor blade.
SUMMARY OF THE INVENTION The invention is a retractor device for minimally invasive surgery that incorporates independent, discrete, removable extension members in the form of shields or barriers that are selectively attached at, adjacent or to the end of a tubular retractor, or at, adjacent or to the ends or sides of blade retractors, so as to extend therefrom in order to fill any gaps between the distal end of the retractor and the bone, organ or other body component of concern, such that tissue is precluded from creeping or herniating into the gap. The extensions may be mounted to the retractor at multiple chosen locations utilizing various mechanical interlocking, clipping or similar joining techniques, and the extensions may vary in shape, size, thickness and other characteristics. The extensions may be preformed with a fixed curvature so as to match the interior curvature of the retractor, or they may be composed of a flexible material such that they adapt to the interior curvature of the retractor upon affixation. The extensions may be provided with teeth, apertures, slits or the like to better prevent tissue creep. The extensions are attached to the retractor after the retractor has been positioned in the patient.
In a preferred embodiment, the extension members are clipped to the end or exposed edge of a tubular retractor, or to the ends, sides or exposed edges of a blade retractor, using a generally J- or U-shaped clip member located on the extension member. In an alternative embodiment the extension member comprises a compressible slotted annular band whereby the extension member is retained against the inner wall of the tubular retractor by biasing forces.
Specialized equipment or tools allow the surgeon to grasp or secure one or more chosen extensions, to insert the extension into and down the retractor, and to affix the extension to the interior wall or distal end of the retractor. In a preferred embodiment, the applicator or insertion tool comprises a forceps-type device having a means to temporarily retain one or two extension members on a pair of extended L-shaped arms, wherein squeezing a pair of handles results in separation of the L-shaped arms.
It is contemplated that the invention may be provided to surgeons in the form of a kit, such kit comprising a plurality of extension members of varying shapes and sizes, an applicator tool, and possibly a depth gauge.
BRIEF DESCRIPTION OF THE DRAWINGSFIG. 1 is an exploded view of the invention showing a tubular retractor and an extension member having a mounting post.
FIG. 2 is a perspective view showing the distal end of the tubular retractor with the extension member affixed.
FIG. 3 is a partial cross-sectional view of the distal end of the tubular retractor with a pair of extension members mounted thereto, with one being shown in cross-section.
FIG. 4 is a perspective view of an alternative embodiment of the extension member having a mounting clip.
FIG. 5 is a perspective view of the distal end of an alternative embodiment tubular retractor having a pair of the extension members ofFIG. 4 mounted thereto.
FIG. 6 is an end view of the distal end of the tubular retractor ofFIG. 5.
FIG. 7 is a side view of an applicator tool for positioning the expansion members.
FIG. 8 is a partial view of the end of the applicator tool, having a single extension member shown in cross-section and retained thereby.
FIG. 9 is a top view showing a pair of extension members positioned within a tubular retractor prior to connection to the retractor.
FIG. 10 is a front view of another alternative embodiment of the extension member having a pair of mounting clips, teeth and slots.
FIG. 11 is a side view of another alternative embodiment of the extension member having a grasping protrusion and a lip member.
FIG. 12 is a front view of another alternative embodiment of the extension member having extended lateral members.
FIG. 13 is a view of an alternative embodiment for the tubular retractor having a plurality of grid apertures to receive the extension members.
FIG. 14 is a view similar toFIG. 3 of an alternative embodiment for the extension member and mounting means, where a separate U-clip member is employed.
FIG. 15 is a cross-sectional view of the embodiment ofFIG. 13, showing attachment of an extension member and an additional accessory to a fenestrated retractor.
FIG. 16 is a perspective view of an alternative embodiment of the extension member, where the extension member is maintained within a tubular retractor by friction or biasing forces.
FIG. 17 is a partial cross-sectional view of the extension member ofFIG. 16 shown positioned within a tubular retractor.
FIG. 18 is a top view of the extension member ofFIG. 16 shown positioned within a tubular retractor.
FIG. 19 is a view of an insertion or applicator tool for the extension member ofFIG. 16.
DETAILED DESCRIPTION OF THE INVENTION With reference to the drawings, the invention will now be described in detail with regard for the best mode and the preferred embodiments. The invention is a surgical retractor apparatus or assembly and its method of use, the surgical retractor assembly having selectable extension members that are mounted or affixed at, on, to or adjacent the distal end of a tubular retractor member, or the ends or sides of a spreadable blade retractor, such that the distal profile or configuration can be altered to better match the contour of the bone, organ or other body component or better still the shape of a portion of the open area between the distal end of the retractor and the bone, organ or other body component, so as to preclude or minimize intrusion of tissue or other matter by creep or herniation into the access passageway defined by the retractor. The extension members are independent, discrete and removable members, and are attached to the retractor after the retractor has been inserted into the patient. The illustrations show a tubular retractor member that is circular in transverse cross-section, but it is to be understood that it is contemplated that a tubular retractor of elliptical or other cross-sectional configuration may also be utilized. Likewise, it is also to be understood that it is contemplated that the retractor may also comprise one of the type having one or more spreadable blades or finger-like sections, each of the blades or sections having a distal end of fixed configuration, in which case the extension members may be positioned on the sides of the blades as well as on the ends.
The apparatus comprises aretractor member10 comprising a generally elongated main body11 of relatively small transverse dimension having aproximal end12 and adistal end13, wherein thedistal end13 is adapted to be inserted into the body through a relatively small incision or opening, whereby an access pathway is created that enables the surgeon to visualize and perform procedures in the interior of the patient. The length of the main body11 is chosen such that theproximal end12 remains disposed externally to the body during the procedure. As shown inFIG. 1, theretractor member10 may comprise a tubular main body11 that is circular in transverse cross-section, with thedistal end13 andproximal end12 lying in planes perpendicular to the longitudinal axis. Alternatively, the main body11 may be elliptical or otherwise non-circular in cross-section, and thedistal end13 andproximal end12 may be disposed in non-perpendicular planes or may have non-planar configurations, such as for example when a spatula-like configuration is provided on thedistal end13.
Theextension members20 are independent, discrete, removable members distinct from theretractor member10 and may be composed of varying materials and comprise a shieldingmain body28 having varying shapes and sizes. Preferably, theextension members20 are relatively thin so as to only minimally diminish the size of the access opening provided by theretractor member10. In a preferred embodiment, theextension members20 are composed of a plastic material such that themain body28 is able to flex so as to conform to the interior curvature of theretractor member10 when mounted thereon. For example, as shown inFIGS. 1 through 5, the extension membermain bodies28 may be relatively planar prior to connection to theretractor member10, becoming curved upon being forced against theretractor member10 for attachment. Alternatively, themains bodies28 of theextension members28 may be formed with a relatively rigidcentral portion41 acting in the form of a “backbone”, with relatively flexiblelateral portions42 extending to either side of thecentral portion41, as shown in FIG.10. Thecentral portion41 may be formed as a thicker region, may be composed of a different material possessing more rigidity than the material composing thelateral portions42, or may comprise ridges or similar reinforcing structures. Furthermore, themain bodies28 of theextension members20 may be preformed with a fixed curvature matching that of the interior of theretractor member10. The particular shapes of theextension members20 may vary, such that they may be symmetrical or asymmetrical, thereby allowing a surgeon to choose the shape that best fills the gap between thedistal end13 of theretractor member10 and the bone, organ or body component in any given procedure. Examples of differing configurations, not to be taken as limiting, are shown inFIGS. 1, 4,10,11 and12. The dimensions of theextension members20 may vary in height or width, such that for example oneextension member20 may extend a short distance axially but cover a large distance circumferentially, or vice versa. As shown inFIG. 10, theextension members20 may be provided with teeth24,slots25 or other surface or body elements to better secure the tissue at thedistal end13 of theretractor member10 to prevent creep, herniation or intrusion. As shown inFIG. 11, theextension members20 may be provided with adistal lip member26 for this same purpose.
Mounting means30 are provided to affix or attach one ormore extension members20 in a fixed, non-moving, manner at or adjacent thedistal end13 of theretractor member10, while theretractor member10 is positioned within the patient, such that theextension members20 extend beyond thedistal end13.Multiple extension members20 may be abutted or overlapped if necessary. Mounting means30 may comprise any suitable affixation mechanism, although a mechanical interlock is preferred over adhesive bonding or the like. One embodiment for mountingmeans30 is shown inFIGS. 1 through 3, where mounting means30 comprises in combination a plurality of mechanical interlocking members comprising mountingapertures31 and mountingposts32, with theapertures31 disposed in the main body11 near thedistal end13 ofretractor member10 and theposts32 disposed on the exterior side of theextension members20. To attach theextension member20 to theretractor member10, the mountingpost32 is pressed into the mountingaperture31, theelements32 and33 being sized such that thepost32 is retained by theaperture31 by friction or by expansion of acompressed post32 to create a mechanical interlocking. The mounting means30 should secure theextension member20 with sufficient retention such that theextension member20 will not be dislodged during the surgical procedure or upon removal of theretractor member10.
Alternatively, mounting means30 may comprise recessed mechanisms, spring-biased mechanisms, clip mechanisms or any other suitable means for mounting theextension members20 to theretractor member10. A preferred mounting means30 comprising one or more generally J- or U-shaped clip orhook members33 is shown inFIGS. 4 through 12, where theclip member33 is sized and spaced a selected distance from themain body28 of theextension member20 so as to securely receive the edge of thedistal end13 of theretractor member10, theclip member33 preferably being either biased outwardly when theextension member20 is brought upward onto the edge of thedistal end13 of theretractor member10 or being pulled against theretractor member10 when theextension member20 is flexed to adopt the curve of theretractor member10. The provision ofplural clip members33 on asingle extension member20, as shown inFIG. 10, acts to prevent undesired pivoting or translation of theextension member20 relative to theretractor tube10 after affixation.
Still another embodiment for theextension member20 and mounting means30 is shown inFIG. 14, where theextension member20 is provided with a slot oraperture36 that receives a separate U-shaped clip member35 that is mounted onto thedistal end13 of theretractor tube10. With this embodiment, as with the embodiment ofFIGS. 1 through 3, theextension member20 can be positioned without first over-advancing theextension member20 beyond thedistal end13 and then retracting to seat theclip member33.
Another embodiment for theextension member20 is shown inFIG. 12, where theextension member20 is provided withlateral wing members27 that greatly extend the lateral dimension of theextension member20. With this configuration it is easy to overlapmultiple extension members20. Furthermore, such a configuration is useful for application to retractors of the spreadable blade type, since by their nature axially oriented gaps are created between the arms or blades of the retractor when such arms are expanded.
Grasping forceps may be utilized to position theextension members20 within theretractors members10, but preferably specially adapted extended tools, forceps or similar grasping instruments are provided to attach theextension member20 to theretractor member10 after theretractor member10 has been inserted into the body. Arepresentative applicator tool90 is illustrated inFIGS. 7 through 9, wherein thetool90 is designed such that theextension member20 is pressed against the interior wall of theretractor member10 by squeezing thehandles91, theapplicator tool90 being spring biased so as to remain in the closed position until force is applied to thehandles91. Thehandles91 are pivotally joined by pivot means92 to L-shapedarm members93, the length of the L-shapedarms93 being greater than the length of theretractor member10. Extension member retention means94 are disposed adjacent or near thedistal end96 of thearms93. The extension member retention means94 as shown comprisepin members95 that are received withintool apertures22 disposed in theextension members20. To apply theextension members20 of the embodiment shown inFIGS. 1 through 3, one or twoextension members20 are temporarily affixed to thepin members95, theextension member20 is properly positioned at thedistal end13 of theretractor member10, and thehandles91 are closed to expand the L-shapedarms93, thereby forcing thepost member32 of theextension member20 into the mountingaperture31. For the embodiment of theextension member20 shown inFIGS. 4 through 10 and12, theextension member20 is inserted through the distal end13 a sufficient distance for theclip member33 to clear thedistal end13, then theextension member20 is retracted to seat theclip member33 on thedistal end13 of theretractor member10.
Alternatively, the tool connector means21 of theextension members20 may comprise internally extending grasping projections ornubs23, as shown inFIG. 11, such that conventional forceps or the like may be utilized to grasp and place theextension member20. In a different embodiment, a bayonet-type applicator tool may be utilized to position theextension member20, the bayonet-type applicator tool having an axially offset handle portion to allow visualization within theretractor member10.
The embodiments of the extension members shown inFIGS. 4 through 12 and inFIG. 14 are advantageous in thatstandard retractor members10 currently in production do not need to be altered, since theextension members20 are clipped onto thedistal end13 of the tubular retractor. For the embodiment shown inFIGS. 1 through 3, theretractor tubes10 must be provided withcorresponding apertures31 to receive the extension member posts32. This design somewhat limits the location of theextension member20 on theretractor member10, but the provision of a relatively large number ofapertures31 addresses this issue. In an alternative embodiment of theretractor member10, as shown inFIG. 13, afenestrated retractor member10 comprises a large number ofgrid apertures34, which may comprise various shapes, patterns and concentrations, such that theclip members33 of theextension members20 can be positioned at multiple locations. Theclip members33 may extend in any direction, including the distal, proximal or lateral directions. At least some of thegrid apertures34 are axially spaced along theretractor member10, such that thegrid apertures34 are not equidistant from thedistal end13. Thesegrid apertures34 may extend the entire length of theretractor member10. With this configuration theextension members20 can be inverted such that theclip members33 extend distally, which may enable better placement of the extension members in certain circumstances, as shown inFIG. 15. Additionally,other accessories99 such as light sources, scopes, suctions, irrigators, etc. may be mounted into thegrid apertures34 in similar manner usingclip members98, with theclip members98 extending in any direction, including the distal, proximal or lateral directions. Theclip members98 may be removable attachments to theaccessories99 or manufactured to be an integral member. Both of these embodiments may be incorporated into either tubular or blade retractors.
Another alternative embodiment for theextension member20 is shown inFIGS. 16 through 18. In this embodiment, theextension member20 is retained within thetubular retractor member10 by frictional or biasing forces. Theextension member20 comprises a shieldingmain body28 depending from a slotted annular collar orring member29. The shape of themain body28 may vary. Thecollar member29 is sized such that its outer diameter matches that of the inner diameter of thetubular retractor member10 within a small tolerance, such that theextension member20 can be advanced down the interior of theretractor member20 and is retained in the desired location at thedistal end13 by frictional forces, or preferably is sized and configured such that the ends of the slottedcollar member29 must be compressed slightly in order for theextension member20 to be inserted into theretractor member10, whereby biasing forces retain theextension member20 at the desired location. Theextension member20 may be shaped much less circular than shown in the drawings in the neutral state, depending on the range of flexation inherent in the material of construction. In the case of a pure frictional fit, thecollar member29 may be non-slotted, i.e., comprising a full 360 degree circle. An alternative insertion orapplicator tool90 is shown inFIG. 19, thetool90 comprising anelongated handle91 connected to aram member97, which is annular as shown but may comprise a cylinder or other shape.
Preferably, the invention is provided as a kit comprisingmultiple extension members20 of varying sizes and configurations, along with theapplicator tool90 and a depth gauge, such that the configuration of thedistal end13 of anystandard retractor member10 can be reconfigured as needed to prevent tissue creep.
The methodology of the invention comprises the steps of inserting aretractor member10 into the body of a patient, this step being performed in standard manner. The surgeon then accesses the situation at thedistal end13 of theretractor member10 to determine whether undesirable tissue creep is occurring or is likely to occur during the procedure. To preclude or minimize such tissue creep, the surgeon selects an appropriately sized and shapedextension member20, inserts it into interior of theretractor member10 using an appropriate applicator orinsertion tool90, and secures it to or adjacent thedistal end13 of theretractor member10 in any of the manners discussed above. If necessary,multiple extension members20 can be positioned at different points about thedistal end13, with theextension members20 abutting, overlapping or separated. Theextension members20 may be repositioned or removed as necessary during the surgical procedure. Upon completion of the procedure, theextension members20 may be detached and removed prior to removal of theretractor member10, or may be left in place and removed in combination with theretractor member10.
It is contemplated that equivalents and substitutions to certain elements set forth above may be obvious to those skilled in the art, and thus the true scope and definition of the invention is to be as set forth in the following claims. It is further expressed that the above examples and illustrations are meant to be representational rather than limiting in nature.