CROSS REFERENCE TO RELATED APPLICATIONS The present application is a continuation of U.S. Non-Provisional application Ser. No. 10/616,707, filed Jul. 10, 2003, which claims priority from U.S. Provisional Application Ser. No. 60/395,234, filed Jul. 11, 2002. Both of these applications are hereby incorporated herein by reference.
TECHNICAL FIELD AND BACKGROUND ART The invention relates to surgical devices and methods, and in particular to devices and methods for vaginal and perineal surgery.
In present techniques for vaginal surgery, it is necessary for a surgeon to be assisted by other personnel during an operation in order to retract the vaginal walls. Typically, a weight retractor is used to retract the back wall of the vagina while the assisting personnel retract the other walls of the vagina. The presence of the other personnel to assist in retraction can make the surgery more difficult by crowding the surgeon's range of motion. It may also be more costly for the surgeon, and prevent the personnel who are assisting in retraction from performing other tasks to aid in the surgery.
SUMMARY OF THE INVENTION In an embodiment of the invention, a retraction device for gynecological procedures on a patient comprises a frame attached to a handle and at least one retractor adjustably mounted to the frame. The frame may have one or more fissures that hold suture material during a surgical procedure. The frame may be attached to the handle with a hinge. In a particular embodiment, the hinge includes a ratchet mechanism.
In another embodiment of the invention, the retraction device includes a jig for adjustably mounting the retractor to the frame. The frame of the retraction device may Alternatively, the frame may include a slot, which may be corrugated, in which the jig is positioned in the slot. Another alternative includes having a portion of the edges of the frame corrugated, the jig configured to contact the edge of the frame. The jigs used in embodiments of the invention may include locks.
In an alternate embodiment of the invention, a retraction device includes a support element that is attached to the handle for retaining the device in a position. The support element may include a sheet capable of retaining the device using the weight of the patient. Alternatively, the support element may include a sheet attached to at least one rod, the rod being configured to fit into a track. A support element may also comprise a bar which is attachable to a table. A bracket or a jig may be used to attach the support element to the handle of the retraction device.
In other embodiments of the invention, a retraction device includes one or more of the retractors having a curved blade, and a retractor-handle attached to the frame. The retractor-handle may have a groove along a portion of the length of the retractor-handle; the groove having differential width in varying portions of the groove. The retractor handle may be attached to the frame with a jig. A hinge may be used to attach the curved blade to the retractor-handle. The hinge may include a ratchet-type mechanism or be configured as a ball-type hinge. The curved blade of a retractor may be configured to form a groove capable of supporting another blade. The retraction device may include an anterior retractor, a posterior retractor, or a side retractor.
According to another embodiment of the invention, a method of retracting the walls of a patient comprises: providing a retraction device including a frame, and a plurality of retractors mounted on the frame; and retracting the vaginal walls with the retractors, such that the frame maintains a separation of the retractors and the vaginal walls. The method may provide for a retraction device that includes a handle for mounting the frame in a desired position. The method may also provide for a retraction device with means of adjustably mounting the retractors on the frame.
BRIEF DESCRIPTION OF THE DRAWINGS The foregoing features of the invention will be more readily understood by reference to the following detailed description, taken with reference to the accompanying drawings, in which:
FIG. 1 shows a handle and frame of a self-retaining retractor device according to an embodiment of the invention;
FIG. 2 shows a cross-sectional view of the frame of the self-retaining retractor of the embodiment ofFIG. 1;
FIG. 3 shows a frame with a groove through which a jig runs to support a retractor according to an embodiment of the invention;
FIG. 3A shows a cross-sectional view of the self-retaining retractor device of the embodiment ofFIG. 3;
FIG. 4 shows a frame with a corrugated groove through which a jig runs to support a retractor according to an embodiment of the invention;
FIGS. 4A and 4B show a jig which may be used with the frame ofFIG. 4;
FIG. 5 shows a frame with a corrugated edge to which a jig may attach, supporting a retractor, according to an embodiment of the invention;
FIGS. 5A-5C show a jig which may be used with the frame ofFIG. 5;
FIG. 6 shows a self-retaining retractor device with a support element to support the device using the weight of a patient according to an embodiment of the invention;
FIG. 7 shows a self-retaining retractor device with an anterior retractor having a blade supported by a curved blade and a table-mounted support element according to an embodiment of the invention;
FIG. 8 shows a side view of an anterior retractor for a self-retaining retractor device according to an embodiment of the invention;
FIG. 9 shows a perspective view of an anterior retractor for a self-retaining retractor according to an embodiment of the invention;
FIG. 10 shows a side view of a retractor for a self-retaining retractor device in which the blade and retractor-handle are attached with a ball-hinge according to an embodiment of the invention;
FIG. 11 shows a long blade for use with an anterior retractor according to an embodiment of the invention;
FIG. 12 shows a top view of a posterior retractor for a self-retaining retractor device according to an embodiment of the invention;
FIG. 13 shows a view of a side retractor for a self-retaining retractor device according to an embodiment of the invention;
FIG. 14 shows a side view of either a side or posterior retractor for a self-retaining retractor device according to an embodiment of the invention;
FIG. 15 shows a retractor without a slot for a self-retaining retractor device according to an embodiment of the invention;
FIG. 16 shows a jig that may be used with the retractor depicted inFIG. 15;
FIG. 17 shows a support element for a self-retaining retractor according to an embodiment of the invention;
FIG. 18 shows side view of a table-mounted support element configured to fit into a cylindrical track of a table for a self-retaining retractor according to an embodiment of the invention;
FIG. 18A shows a perspective view of the support element ofFIG. 18;
FIG. 19 shows another support element for a self-retaining retractor utilizing a bar as wide as an operating table according to an embodiment of the invention;
FIG. 20 shows a bracket to attach a support element to the handle of a self-retaining retractor device according to an embodiment of the invention;
FIGS. 21A and 21B show bottom and top views of a jig for a self-retaining retractor according to an embodiment of the invention; and
FIGS. 22A and 22B show bottom and top views of an alternative embodiment of a jig.
DETAILED DESCRIPTION OF SPECIFIC EMBODIMENTSFIG. 1 shows a handle and frame of a self-retaining retractor device, according to an embodiment of the invention, that removes the need for personnel to assist a surgeon in keeping the vaginal walls or perineal incision retracted, and allows for smooth, complete retraction of the side walls, with the best possible surgical field; the device may be set up by a surgeon without assistance. A racket-shapedrigid frame1 contains atrack2 along which a surgeon may smoothly adjust the location of a set of retractors, without the need for assisting personnel. Ahandle4 is connected to theframe1 by ahinge3, so that theframe1 may be moved to firmly contact the patient. Aratchet mechanism6 near the hinge allows the angle between theframe1 and handle4 to be adjusted, while holding theframe1 in place against the patient. In one embodiment according to the invention, the major axis of the frame is, for example, 14 cm. in length, while the minor axis is 12 cm. in length.
FIG. 2 shows a cross-sectional view of the frame of the self-retaining retractor device of the embodiment ofFIG. 1. A raisedportion101 of the frame's cross-section functions as a rail, along which the surgeon may slide a set of jigs (depicted inFIG. 21) that are attached to the retractors (also discussed below). Thereverse side102 of the frame contacts the patient, and is smooth, so that the jigs for the retractor may be moved around the raisedportion101 on the reverse side of the frame without directly touching the patient.
The embodiment ofFIG. 1 depicts one mechanism for mounting one or more retractors to the frame of the device. However, embodiments of the invention include any means by which a retractor may be adjustably mounted to the frame of the device, and are not limited to the use of a track or rail or jig. Several non-limiting examples are discussed herein.
FIG. 3 shows thetrack2 could be substituted by agroove35 that runs along the length of the frame. Through the groove runs a jig36 (shown inFIG. 3A) comprised of a screw with a flat circularlower end37 and a spring-loaded sheet ofmetal38 to support its place on the groove, the upper end will be a screw and a flange-nut combination39 to hold the different retractors.
FIG. 4 shows thetrack2 could be substituted by acorrugated groove40 that runs along the frame. Through the groove a jig41 (shown inFIGS. 4A and 4B) comprised of a body with acavity42. Apin43 at its open end holds twoarms44 in a scissors manner to engage to the dents in the groovedtrack40. These arms are kept in the open position by the help ofspring metals45. A screw and flange-nut combination attached to the body may be used to hold the different retractors.
FIG. 5 shows the frame with smooth front and back surfaces, and outer and inner edges which are corrugated46 and along which a jig may be run. The jig (shown inFIGS. 5A-5C) is comprised of abody47 with acavity48 in which twoparallel arms49 held by twodeferent pins50. The two arms are kept in the retracted position by the help ofmetal spring51. A screw and flange-nut combination attached to the body to hold the deferent retractors.
Persons skilled in the art will readily realize that the frame of the retraction device may take on a variety of shapes that are convenient for holding retractors during gynecological procedures; the frame is not limited to the shape shown inFIG. 1. As an example, an embodiment of the invention may include a frame, as shown inFIG. 5, that alters the frame shape to include a lower portion curved55 into the space enclosed by the frame in order to allow retractors to be attached closer to one another.
Returning toFIG. 1, agroove5 in thehandle4 of the retraction device allows a support element (discussed further below) to attach to thehandle4; circularly widened portions of thegroove5 allow room for a screw and flange-nut combination (shown elsewhere) to attach the support element to thehandle4. The vertical position of the retraction device during surgery may be adjusted by moving the position of the screw and flange-nut combination to different positions in thegroove5. As shown further below, a screw and flange-nut combination7 holds the posterior retractor to the frame, while screw and flange-nut combination9 holds the anterior retractor to the frame. As is apparent to those skilled in the art, the adjustment of the support element relative to the handle may be carried out by a variety of mechanisms, not limited to the specific embodiment described here.
Small fissures8 in the raisedportion101 of the frame, shown inFIG. 2, may be used to allow holding of suture material for tagging or retraction, during surgery. Such fissures may, for example, contain projections that hold the suture material in position once the suture is pulled through the fissure in one direction, and from which the suture may be released when desired.
FIG. 6 shows an assembled view of a self-retaining retractor device, according to an embodiment of the invention. In the embodiment shown inFIG. 6, fourmovable retractors10,17,21 (one on each side) are used, including ananterior retractor10, aposterior retractor17, and twoside wall retractors21; typically, from two to four retractors may be used, but other numbers may also be used in accordance with embodiments of the invention. Threealternative versions25,31, and34 of a support element are shown inFIGS. 6, 7,17,18, and19. Thefirst version25 of the support element allows the device to be retained in position for surgery by the patient's weight, by havingsupport element25 held between the patient's buttocks and the operating table. The second andthird versions31 and34 (described later) of a support element allow thehandle4 to be attached to the operating table using the support element.
FIG. 7 shows an oblique view of fully assembled self-retaining retractor device when utilized on patient. The view shows theretractors10,17,21 fully extended and the angle of the anterior retractor open to its greatest extent. Further reference numerals indicated inFIGS. 6 and 7 are discussed in each of the detailed component views of the remaining figures.
FIGS. 8 and 9 show a side view and a perspective view, respectively, of ananterior retractor10 for a self-retaining retractor device according to an embodiment of the invention. A paddle orblade11 of the anterior retractor has curved sides (seeFIG. 3B) that allow a longer blade to be slid into thecurved blade11 as necessary during surgery. Blades of varying lengths may be utilized with the curved blade as desired. Theblade11 is attached to the anterior retractor'shandle12 by ahinge14, which allows gentle widening of the angle of retraction according to the desire of the surgeon. Aratchet mechanism15 allows the angle of theblade11 with respect to thehandle12 to be adjusted, while holding theblade11 at the chosen angle. Similar hinge and ratchet mechanisms may be used on other retractors (such as a posterior retractor or side retractor) in accordance with embodiments of the invention. Other mechanisms may also be used to hold a particular angle of the blade with respect to the handle. As another example, shown inFIG. 10, a screw andnut combination56 may be used to attach a retractor blade to the frame with aball type hinge57 that allows adjustment of the angle of the retractor blade.
In a particular embodiment, agroove13 in thehandle12 allows attachment of theanterior retractor10 to theframe1 using a jig (as shown inFIGS. 6 and 7), and contains an area of circular widening to allow room for a flange-nut of the jig (shown further below). The vertical position of theanterior retractor10 may also be adjusted by moving the position of the flange-nut in thegroove13.
FIG. 11 shows along blade16 for use with an anterior retractor, in accordance with an embodiment of the invention. Thelong blade16 may be inserted into the groove of the anterior retractor'sblade11 in order to give a deeper view of the surgical field. Similar blades of varying lengths may be fitted into other retractors (such as theposterior retractor17 or side retractors21) in accordance with embodiments of the invention.
FIG. 12 shows a top view of aposterior retractor17 for a self-retaining retractor device according to an embodiment of the invention. Theposterior retractor17 has a curved paddle orblade18 and ahandle19. As with the anterior retractor, agroove20 in thehandle19 has areas of circular widening to allow room for a flange-nut of a jig (shown further below) that attaches theposterior retractor17 to frame1 (as shown inFIGS. 6 and 7).Groove20 also allows for adjustment of the vertical position ofposterior retractor17.FIG. 13 shows a view of aside retractor21 in accordance with an embodiment of the invention, which similarly features a curved paddle orblade22, ahandle23, and agroove24 in the handle for attachment of the retractor (as shown inFIG. 7).Groove24 allows for adjustment of the lateral position of theside retractor21.FIG. 14 shows a side view corresponding to either a posterior or side retractor, according to embodiments of the invention.
Thegrooves13,20,24 in theretractors10,17,21 exemplify one embodiment of the invention that enables the retractors to the attached to the frame. As is apparent to those skilled in the art, other retractor designs may be used to attach the retractors to the frame in accord with embodiments of the invention. Another example, shown inFIGS. 15 and 16, depicts the retractor-handles being made ofsolid metal52. Each retractor is held in place by a jig made of two sheets ofmetal53. The lower sheet will have anotch54 for attaching to the retractor. The jig described above may be used to replace any of the jigs utilized herein (e.g. jigs used with the retractor-handle, the frame handle, or support structure); a slot or groove need not be utilized when this type of jig is substituted.
FIG. 17 shows asupport element25 for a self-retaining retractor device according to an embodiment of the invention, which allows the device to be retained in position for surgery by the patient's weight, by havingsupport element25 held between the patient's buttocks and the operating table.Support element25 attaches to the handle4 (seeFIG. 6).Support element25 may be made, for example, of a stainless steel sheet, with aright angle bend26 at its outer end. A jig, which may use a screw and flange nut combination in a similar fashion to the jigs described below inFIG. 21, allows attachment of thesupport element25 to thehandle4, as shown inFIG. 17. Abracket28 may replace the jig, as shown inFIG. 20. Thebracket28 may be made of a stainless steel metal sheet that is folded over approximately one-third of its length. Thebracket28 may be placed over theright angle bend26. Thebracket28 may be attached to thesupport element25 by screws. Thebracket28 will have ascrew29, to attach thebracket28 to thesupport element25, and flange-nut combination27 on its front to which thehandle4 may be attached, as shown inFIGS. 6 and 20. Sterile drapes may be used to cover the right angle bend to prevent patient contact with the jig,bracket28 orhandle4.
FIGS. 7, 18, and18A show an alternative table-mountedsupport element31 for a self-retaining retractor device according to an embodiment of the invention.Support element31 includes two cylindrical rods32 (with spring type sheet on one side), attached to a sheet ofmetal33. Therods32 are configured to fit into a cylindrical track that most operating tables possess.Bracket28 may be placed over the metal sheet after being covered by sterile drapes to secure thesupport element31 to ahandle4, as described above. Alternatively, a jig may be used instead of abracket28, also described earlier.
FIG. 19 shows another table-mountedsupport element34 for a self-retaining retractor device according to an embodiment of the invention.Support element34 includes a bar that is as wide as the operating table, and contains notches in its side members to hook to the operating table.Bracket28 may be placed over thesupport element34 after being covered by sterile drapes to secure thesupport element31 to ahandle4, as described above. Alternatively, a jig may be used instead of abracket28, also described earlier.
FIGS. 21A and 21B show bottom and top views of ajig60 for a self-retaining retractor device according to an embodiment of the invention.Jig60 may be used, for example, to movably attachretractors10,17, and21 to the frame1 (as shown inFIGS. 6 and 7), so that the retractors may be smoothly moved aroundframe1 to achieve the best retraction for the surgical field. Abody61 ofjig60 contains agroove62 that fits around the raised portion101 (seeFIG. 2) of the frame's cross-section, so that thejig60 may slide around theframe1. Alock63, which may use an out-of-center wheel64, may be used to lock thejig60 in position on theframe1. The lock may be used by turning the lock's handle to tighten the jig's grip on the track once the desired location for the retractor on the frame is reached. Ascrew65 extends from thebody61 of thejig60. After placing the handle groove of a retractor (such asretractor10,17, or21), or groove in another component to be attached, over thescrew65, a flange-nut66 secures the component to thejig60. As shown inFIGS. 22A and 22B, the out-of-center wheel64 may be replaced by twocurved spring metals67, which are attached to the lower part of thejig60 that is in contact with theframe body1; thespring metals67 keeping thejig60 in tight contact with the track, and holding thejig60 in a desired position.
The following description provides a non-limiting example of how the self-retaining retractor device may be used. The desiredsupport element25,31,34 is placed under the patient or attached to the operating table. Sterile drapes are used to cover the patient and support element. Thehandle4 is firmly attached to the supportingelement25,31,34 using either a jig orbracket28, which is placed on top of the supportingelement25,31,34, and a screw and flange-nut combination. The position of thehandle4 is chosen to obtain the correct vertical height for theframe1. The blade of theposterior retractor17 may be inserted into the patient first, and then secured to theframe1 by a screw and flange-nut combination. Then the blade of theanterior retractor10 may be inserted, and secured to the frame; its vertical position and position ontrack2 may be adjusted; and its angle may be adjusted usingratchet mechanism15. Then theside retractors21 may be inserted, and their lateral position and position ontrack2 adjusted. However, the particular order of insertion of the retractors, as well as their positioning and angling, may be adjusted according to the nature and progress of the surgery, as will be recognized by those of skill in the art in accordance with the disclosure herein.
Although various exemplary embodiments of the invention have been disclosed, it should be apparent to those skilled in the art that various changes and modifications can be made which will achieve some of the advantages of the invention without departing from the true scope of the invention.