US20150351858A9 - Surgical alignment system, apparatus and method of use - Google Patents

Abstract

A surgical positioning system is provided that includes a radiolucent grid having a plurality of dimensioned radio-opaque lines corresponding to surgical variables and a substrate connect to or integral with the radiolucent grid. This system is used to obtain subject specific data from an image of a subject obtained during a surgical procedure by following the steps of: providing a radiolucent grid having a plurality of dimensioned radio-opaque lines relating to surgical variables; placing the subject on a substrate; and obtaining subject specific data from an image of said subject. This invention related to an apparatus made of a radiolucent grid having a plurality of dimensioned radio-opaque lines relating to surgical variables and a sealable radiolucent container sized to receive the grid.

Description

CROSS REFERENCE TO RELATED APPLICATION
• This continuation-in-patent application claims the benefit of U.S. provisional patent application Ser. No. 61/525,259 filed Aug. 19, 2011 and PCT/US12/51512 application filed Aug. 18, 2012 under 35 U.S.C. §111(a) (hereby specifically incorporated herein by reference).
STATEMENT REGARDING FEDERALLY SPONSORED RESEARCH OR DEVELOPMENT
• None.
REFERENCE TO SEQUENCE LISTING, A TABLE FOR A COMPUTER PROGRAM LISTING, COMPACT DISC APPENDIX
• None.
FIELD OF THE INVENTION
• The present invention relates to a fluoroscopic alignment apparatus and system and method to use this apparatus in various orthopedic applications, such as, an anterior total hip arthroplasty.
BACKGROUND OF THE INVENTION
• Many of the radiographic parameters essential to total hip arthroplasty (THA) component performance, such as wear, and stability, can be assessed intraoperatively with fluoroscopy. However even with intraoperative fluoroscopic guidance, the placement of an implant may still not be as close as desired by the surgeon. For example, malpositioning of the acetabular component during hip arthroplasty can lead to problems. For the acetabular implant to be inserted in the proper position relative to the pelvis during hip arthroplasty requires that the surgeon know the position of the patient's pelvis during surgery. Unfortunately, the position of the patient's pelvis varies widely during surgery and from patient to patient.
• Various devices have been suggested to reduce malpositioning of these surgical components. For example, a transverse acetabular ligament has been suggested as a qualitative marker of the orientation of the acetabulum. (Archbold H A, et al., The Transverse Acetabular Ligament; an Aid to Orientation of the Acetabular Component During Primary Total Hip Replacement: a Preliminary Study of 1000 Cases Investigating Postoperative Stability, J Bone Joint Surg BR. 1906 July; 88(7):883-7. However, it has been suggested that the acetabulum may be deteriorated due to arthritis. Others have proposed using a tripod device that uses the anatomy of the ipsilateral hemi pelvis as the guide to position the prosthetic acetabular component. U.S. Patent Publication Number 19090306679. This instrument has three points. The first leg is positioned in the area of the posterior inferior acetabulum, a second leg is positioned in the area of the anterior superior iliac spine and a third leg is positioned on the ileum of the subject. U.S. Patent Publication Number 19090306679. However, a need exists in the industry for a device that is not implantable or invasive and is adaptable to a variety of applications.
SUMMARY OF THE INVENTION
• A surgical positioning system is provided that includes a radiolucent grid having a plurality of dimensioned radio-opaque lines corresponding to surgical variables and a substrate connect to or integral with the radiolucent grid. This system is used to obtain subject specific data from an image of a subject obtained during a surgical procedure by following the steps of: providing a radiolucent grid having a plurality of dimensioned radio-opaque lines relating to surgical variables; placing the subject on a substrate; and obtaining subject specific data from an image of said subject. This invention also provides an apparatus made of a radiolucent grid having a plurality of dimensioned radio-opaque lines relating to surgical variables and a sealable radiolucent container sized to receive the grid. This embodiment simplifies the sterilization, if required of the grid plate between surgical applications.
• In another embodiment, the substrate is an operating room table mat and the grid is integrated into the operating room table mat to form a dimensioned grid mat. The dimensioned grid mat has at least one aperture in a top surface sized to accommodate a positioning device. The positioning device is sized to project through and above the top surface of the dimensioned grid mat, wherein the position of a subject on the mat can be maintained in a selected position with the at least one positioning device.
• In another embodiment, the grid is not a complete table or is not integrated into a complete table, but is an independent extension which adapts to any operating room table and/or integrates into, or adapts with, a mobile leg positioner.
• In another embodiment, disposable sterile, or non-sterile, fluoroscopic grid-drape for use intraoperatively, independent of, within, or as an integral part of C-arm drape/sleeve/cover, to determine angulation and alignment of implants and/or limbs is provided.
• In another embodiment, disposable sterile, or non-sterile, fluoroscopic grid having the ability to attach to the C-arm image intensifier by means of any method, such as magnets, suction cups/devices/tapes, clamps, and straps is provided. This includes method of grid attachment to the C-arm image intensifier or any other plate/sleeve/apparatus using adhesives of any type.
• In another embodiment, use of radiopaque ink methods and technology to print a grid pattern for use in any musculoskeletal surgical procedure are provided. The radiopaque ink printing can be applied to any suitable and appropriate substrate.
• All designs and embodiments include sterile/non-sterile, and disposable/non-disposable applications.
BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWING
• The drawing shows schematically a fluoroscopic alignment plate apparatus and method of use according to an example form of the present invention. The invention description refers to the accompanying drawings:
• FIG. 1 is a perspective view of an embodiment of the dimensioned grid plate of the present invention.
• FIG. 2 is a front view of an embodiment of the dimensioned grid plate apparatus of the present invention.
• FIG. 3 is a side view of an embodiment of the dimensioned grid plate apparatus of the present invention.
• FIG. 4A is a side view of the apparatus of the present invention.
• FIG. 4B is a top view of the translational/rotational mechanism of the present invention.
• FIG. 5 is a rear view of an embodiment of the dimensioned grid plate apparatus of the present invention.
• FIG. 6A is an illustrative sketch showing the relationship of the patient to the apparatus in an anterior approach.
• FIG. 6B is an illustrative sketch showing the relationship of the patient to the apparatus in a posterior approach.
• FIG. 7 is a front view of another embodiment of the dimensioned grid plate apparatus of the present invention.
• FIG. 8 is a sketch of X-ray view showing hip anatomy with or without implant and the grid overlay.
• FIG. 9 is a schematic of an X-ray view of the hip anatomy with implant grid overview.
• FIG. 10 is a perspective view of the grid of the present invention; and a view showing the pouch/bag/container.
• FIG. 11A is a front perspective view of the apparatus of the present invention used in a standard X-ray image technique where the grid is placed on top of the patient and images taken as needed.
• FIG. 11B is a top view of the apparatus of the present invention used in a standard X-ray image technique where the grid is placed on top of the patient and images taken as needed.
• FIG. 12 is an embodiment of the invention show a rear view of an embodiment of the dimensioned grid plate apparatus of the present invention.
• FIG. 13A is an embodiment of the invention showing an illustrative sketch showing the relationship of the patient to the apparatus in an anterior approach.
• FIG. 13B is an embodiment of the invention showing an illustrative sketch.
• FIG. 14 is a view of the apparatus of the present invention used externally and integrated into the table mat/support system.
• FIG. 15 is a view of the apparatus of the present invention integrated into the operating room table and patient positioning system.
• FIG. 16 is a top view of one embodiment of the grid apparatus and the use of positioning devices to position the subject.
• FIG. 17A is an embodiment of the invention showing the relationship of the grid and other associated intra-operative tables and patient positioning equipment.
• FIG. 17B is an embodiment of the invention showing the relationship of the grid and other associated intra-operative tables and patient positioning equipment.
• FIG. 17C is an embodiment of the invention showing the relationship of the grid and other associated intra-operative tables and patient positioning equipment.
• FIG. 18 is an embodiment of the invention showing a mobile leg positioner relative to a grid.
• FIG. 19 is an embodiment of the invention showing an example of grid geometry pattern wherein the grid can be a single line, a geometrical patter, number, letter or a complex pattern of multiple lines and geometries.
DETAILED DESCRIPTION OF THE INVENTION
• The present invention may be understood more readily by reference to the following detailed description of the invention. It is to be understood that this invention is not limited to the specific devices, methods, conditions or parameters described herein, and that the terminology used herein is for the purpose of describing particular embodiments by way of example only and is not intended to be limiting of the claimed invention. Also, as used in the specification including the appended claims, the singular forms “a,” “an,” and “the” include the plural, and reference to a particular numerical value includes at least that particular value, unless the context clearly dictates otherwise. Ranges may be expressed herein as from “about” or “approximately” one particular value and/or to “about” or “approximately” another particular value. When such a range is expressed, another embodiment includes from the one particular value and/or to the other particular value. Similarly, when values are expressed as approximations, by use of the antecedent “about,” it will be understood that the particular value forms another embodiment.
• These and other aspects, features and advantages of the invention will be understood with reference to the detailed description herein, and will be realized by means of the various elements and combinations particularly pointed out in the appended claims. It is to be understood that both the foregoing general description and the following detailed description of the invention are exemplary and explanatory of preferred embodiments of the inventions, and are not restrictive of the invention as claimed. Unless defined otherwise, all technical and scientific terms used herein have the same meaning as commonly understood by one of ordinary skill in the art to which this invention belongs.
• The present invention, provides an apparatus and method for determining and measuring leg length, offset, and cup position during arthroplasty surgery by using a radiolucent dimensioned grid plate positioned under the patient in conjunction with X-ray to measure surgical variables, such as, hip implant position to determine the relative leg length and offset measurements for the implant. Arthroplasty surgery includes, for example: hip (anterior approach), hip (posterior approach), knee, ankle, elbow, and shoulder. The present invention includes an embodiment for trauma applications. Trauma surgery includes any and all bone fractures.
• Now referring toFIG. 1 a radiolucent dimensionedgrid plate1 is designed to be sufficiently large to ensure that the body part in questions, such as the entire pelvis and proximal femurs (left and right), is captured in a fluoro image. The radio-opaque grid (any and all metals, ceramics, plastics, complex materials such as carbon fiber) has a (1 cm) quantifiable pattern or indicator (other quantifiable patterns, English) with each individual “block” having a square geometry. These grid lines align parallel to each other in two directions—vertical (cephalad/caudad)14 and horizontal (medial/lateral)2. However, it should be understood that the geometry of the grid lines can vary depending upon the surgical procedure and surgical requirements. For example,FIG. 18 shows a radiolucent dimensionedgrid plate1 with a complex design used for both a hip and a trauma application. The design can also be as simple as one (1) 40 degree line (for cup abduction angle) or one horizontal line (for leg length).
• Now referring toFIG. 2, a radiolucent dimensionedgrid plate1 for hip arthroplasty is provided. The radiolucent dimensionedgrid plate1 is “sandwiched” betweensupport plates4 that have anextended aspect6 in the caudal direction, to form the radiolucent dimensionedgrid plate apparatus19. This caudal aspect has acutout5 that matches and mates with an operating room table's peg for use in an anterior approach procedure. The outer layer of thesupport plates4 are joined together at thecorners15 by a solid metal piece that will also serve as the attachment place for the clamps that will attach the a radiolucent dimensionedgrid plate apparatus19 to the operating room table72 or to the hip positioning apparatus (not shown). For strength, support rods (not shown) can be added to the caudal aspect.
• In this radiolucent dimensionedgrid plate1, two grid lines form a V and are angled at 45 degrees to the vertical and horizontal. In this dimensionedgrid plate1, these two lines represent aguide3 for quantifying the abduction angle of an acetabular cup used during an arthroplasty procedure. However, the desired angle for theguide3 relates to the type of implant. Metal on metal implants use a 40 degree angle of abduction, while polyethylene based articular surfaces use a 45 degree angle. The left half side of the radiolucent dimensionedgrid plate apparatus19 is a mirror image of the right hand side. The radiolucent dimensionedgrid plate1 can have the following radio opaque markings (any and all methods of etching or marking): Two 45 degree angled radioopaque guide lines3; two elliptical etchings which represent the proper version of theacetabular component8 adjacent and cephalad to the 45 degree lines with a distance of approximately 19 cm from the apex of the two 45 degree lines (correlates to average standardized measurements of human pelvis between the radiolucent lines representing the quadrilateral surface, the roof of the obturator foramen, and the fossa acetabulae (the “teardrop”)); numbers representing the vertical lines with zero being the midline and the numbers counted off in both medial and lateral directions from zero10; letters of the alphabet on both sides of the grid representing the horizontal (x-axis)9; and an image of an anatomical feature, such as a pelvis outline. All these grid lines and markings guide the physician in defining the orientation for insertion of the implants and specifically determining and measuring leg length, offset, cup placement, and femoral head center of rotation and mechanical axis of lower limb.
• The radiolucent dimensionedgrid plate1 can be enclosed on either side in an epoxy resin that is both transparent and with a plurality ofsupport plates4 to form the radiolucent dimensionedgrid plate apparatus19. The epoxy creates a complete seal for the metal to prevent corrosion and support cleanability of the radiolucent dimensionedgrid plate apparatus19. Other manufacturing processes known to those skilled in the art include: laser etched: etched, then filled with radio-opaque marker in etched negative areas, then sandwiched; molded: with metal onsupport plates4; using tungsten as the radio-opaque material for use in grid lines and numbers; sandwich deposition: printing process (like circuit boards); CNC Machined: back filled and radio-opaque decal: use of radio-opaque ink placed onsupport plates4.
• Now referring toFIGS. 3,4A and4B, a plurality ofsupport plates4 is shown surrounding the dimensionedgrid plate1. Thiscentral axis pin11 is attached to theouter support plates4 by conventional means such as a screw threaded through the support plate into the end of thecentral axis pin11. Thecentral axis pin11 is captured on either end by a screw threaded through thesupport plates4 and into the end of the axis pin—on both ends. A medial-lateral slot13 allows a +/−5 cm medial-lateral translation of the dimensionedgrid plate1 relative to thesupport plates4. Thecentral axis pin11 is oriented perpendicularly to the surface of the plurality ofsupport plates4 and thecentral axis pin11 projects upwardly. This dimensionedgrid plate1 has aslot13. Theslot13 allows the dimensionedgrid plate1 to be shifted from side to side or medially-laterally.
• Now referring toFIGS. 4A and 4B, the dimensionedgrid plate1 articulates within thesupport plates4 by acentral axis pin11. The medial-lateral slot13 allows +/−5 cm medial-lateral translation of the dimensionedgrid plate1 relative to thesupport plates4 and thepatient27. The radiolucent dimensionedgrid plate1 can also be rotated +/−40 degrees about thecentral axis pin11 axis relative to thesupport plates4 and thepatient27. The radiolucent dimensionedgrid plate1 is rotated or translated by using thehandle12 that is attached to the radiolucent dimensionedgrid plate apparatus19. The radiolucent dimensionedgrid plate1 rotates about thecentral axis pin11.
• Theslot13 is configured with scalloped sides or edges that allow the radiolucent dimensionedgrid plate1 to be indexed at a plurality of positions. Thecentral axis pin11 has a centralaxis pin groove21 about which the radiolucent dimensionedgrid plate1 will rotate. The centralaxis pin groove21 will further have a series of countersunkgrooves22 for engagement of spring-loaded ball23 (for location of rotational position of the dimensionedgrid plate1 relative to the outer support plates. Furthermore, the radiolucent dimensionedgrid plate1 translates in a medial lateral direction along thecentral axis pin11. This translational movement is achieved by utilizing countersunkgrooves26 with a spring-loaded device (SLD)24 having a uniform groove and countersunk slot configuration. The indexing is accomplished by a translation/rotational mechanism25. Thecentral axis pin11 has the ability to translate along the medial-lateral slot13 and engage in any one of a series of positions in the medial lateral direction. This is accomplished by having a plurality of spring-loadeddevice25 used in conjunction with a plurality of corresponding countersunkslots26. This rotation is accomplished by the configuration of the mediallateral slot13.
• Theslot13 is made of a plurality countersunkgrooves26 that are configured to retain thecentral axis pin11. Additionally, the surface opposite30 one of the plurality of countersunkgrooves26 is configured to retain a spring-loadeddevice24. A plurality of spring-loadeddevices24 mediate the movement of the radiolucent dimensionedgrid plate1. The spring-loadeddevice25 releasably holds thecentral axis pin11 in the selected scalloped or notched position. The engagement/disengagement position and force will be determined based upon spring-loaded device holding capacity. Thecentral axis pin11 can be fluted longitudinally22 which allows a rotational detent action as the patient (on the radiolucent dimensioned grid plate apparatus19) is rotated in the horizontal plane about thecentral axis pin11.
• Now referring toFIG. 5, on the underside of the radiolucent dimensionedgrid plate apparatus19 there are strips of an adhesive material such as VELCRO (Velcro Industries B.V.)17 to further secure the plate to the operating room table72. This prevents the radiolucent dimensionedgrid plate apparatus19 from moving relative to the operating room table or patient during the surgical procedure. In another embodiment, the radiolucent dimensionedgrid plate apparatus19 can includeposts18 to attach to an operating room table72. The dimensionedgrid plate1 does not need to be secured and can be used in a “free-hand” technique where the radiolucent dimensionedgrid plate apparatus19 is simply held in position—this includes holding the radiolucent dimensionedgrid plate apparatus19 above the patients pelvis or holding a radiolucent dimensionedgrid plate apparatus19 up in front of the fluoro image on the X-ray machine. It should be noted that the radiolucent dimensionedgrid plate apparatus19 is disposable or resterilizable.
• Now referring toFIGS. 6A and 6B, this embodiment allows for use in all surgical approaches to the hip. For the anterior approach, the dimensionedgrid plate apparatus19 is used as shown inFIG. 6A, the patient is in a supine position with the radiolucent dimensionedgrid plate apparatus19 placed beneath the patient's pelvis. For the posterior approach as shown inFIG. 6B. The added benefit is having the ability to rotate, translate ML, and ideally position the grid to the anatomy of the patient. The dimensionedgrid plate1 has the ability to rotate +/−40 degrees from the vertical and translate in the medial lateral direction +/−5 cm. The radiolucent dimensionedgrid plate1 can translate cephalad/caudad by adjusting the clamps which fix the radiolucent dimensionedgrid plate apparatus19 to the bed or the hip positioning device.
• The dimensionedgrid plate apparatus19 can also be used for an anterior approach procedure. The Hilgenreiner'sline31 is a line drawn horizontally through the superior aspect of both triradiate cartilages. It should be horizontal, but is mainly used as a reference for Perkin's line and measurement of the acetabular angle.
• The radiolucent dimensionedgrid plate apparatus19 has an extension in the caudad direction that has enough distance to allow the grid to lock onto the operating room table72 and then also ensure that the radiolucent dimensionedgrid plate apparatus19 is directly behind (posterior) the patient's27 pelvis. The extension piece has a slot or cut out5 that matches the diameter of the peg (not shown) on the operating room table72 that is being used. The peg (not shown) is fixed to the table and so by locking the peg to the plate there will be no motion of the radiolucent dimensionedgrid plate apparatus19 relative to the patient27 during the surgery. In testing that was performed, tables that are conducive to the direct anterior approach were used. The radiolucent dimensionedgrid plate apparatus19 and method can be used on any radiolucent operating room table.
• For a posterior surgical approach,FIG. 6B, thepatient27 is placed in the appropriate position for hip replacement surgery. The surgeon places the patient27 in a Lateral Decubitus position; the surgeon positions the radiolucent dimensionedgrid plate apparatus19 directly behind the pelvis of thepatient27. Once the surgeon has the trial implants or final implants inserted in the correct position inside the body, the surgeon will bring in the mobile X-ray machine (C-arm) and align the C-arm beam with the pelvis and grid plate in the anterior posterior plane. The image generated by the C-arm will provide a fluoro view of the anterior posterior pelvis and a grid pattern overlay. For the use in a posterior surgical approach, the patient27 can be placed on the patient's27 side in an appropriate and traditional manner. The surgeon will examine the X-ray image to determine subject specific data. Three parameters will be measured and determined at this point: 1) leg length, 2) offset, and 3) cup position.
• Leg length: In quantifying leg length discrepancy, the patient's anatomical landmark(s) can be geometrically dimensioned relative to the grid lines. For example, points on the grid line drawn through the bottom of the ischium may be viewed as points on the grid marked along the H grid line. The proximal aspect of the left and right lesser trochanters may be viewed as points on the grid marked as G3 and F3 respectively.
• The distance measured counting or using the grid squares between the ischial axis grid line and the respective two lesser trochanter points (G3 and F3 for example) is the leg length discrepancy. Alternatively, a surgeon's preference may be to use points on the grid marking the greater trochanter in conjunction with the grid lines through the obturator foramina.
• Offset. The offset of the femoral component is the distance from the center of rotation of the femoral head to a line bisecting the long axis of the stem: In a similar technique to leg length, offset can be quantified. Corresponding radiographic points identified on the patient's left and right pelvis and proximal femur can be measured with the grid lines and blocks. The difference between the left and right measurements will quantify the offset mismatch and provide the surgeon with a numerical number to allow restoration of proper offset.
• Pelvic Acetabular Implant commonly referred to as the “cup”: The optimal position of the acetabular component can be determined using the radiolucent dimensionedgrid plate apparatus19 as an alignment and measurement device. The radiolucent dimensionedgrid plate apparatus19 has a 45 degree angledmetal line3. The radiographic image will display the trial or final implanted acetabular cup positioned in the acetabulum relative to the 45degree guide line3 that will be superimposed on the image. The cup position can then be adjusted based upon image feedback until correct positioning of the final implant is determined.
• Now referring toFIGS. 7 and 8, a radiolucent dimensionedgrid plate apparatus19 can be adapted for a variety of end-uses such as to facilitate the placement of an implant in arthroplasty or trauma procedure; for fracture reduction/correction during a trauma procedure or for deformity correction planning. In operation, the proximal femoral angle at40 is determined. Next the distal femoral angle is determined at42 Next theproximal tibial angle46 is determined Next thedistal tibial angle43 is determined to form the “X” axis relative to the “Y”axis35 of the dimensionedgrid plate apparatus19.
• TheY axis35 is the center line that creates a mirror image of grid and reference lines on either side of it, thus allowing use for either a left or aright leg application49 marks the center of the femoral head location. The proximal pelvic section of the device also has two 45 degree lines that intersect at the center of thefemoral head point49. These same lines can also be used to quantifyfemoral neck angle51. Theknee section48 is made of a grid pattern matching that of radiolucent dimensionedgrid plate apparatus19. Similarly, theankle section47 is made of a grid pattern matching that of radiolucent dimensionedgrid plate apparatus19. The knee section has acentral x-axis42. Similarly, theankle section47 hascentral x-axis43. Theknee grid section48 has two 3degree lines46 for use in quantifying alignment as needed.
• In another embodiment, and now referring toFIG. 8, a radiolucent dimensionedgrid plate apparatus19 for use with a trauma procedure on a lower extremity is disclosed. The trauma implications go beyond the pelvis and acetabulum. A larger radiolucent dimensionedgrid plate apparatus19 that runs from the patient's pelvis to beyond the ankle allows a surgeon to confirm length using the contralateral side. Additionally, the radiolucent dimensionedgrid plate apparatus19 allows the surgeon to confirm alignment prior to and after placement of an implant. The y-axis35 correlates with the mechanical axis that runs from the head of the femur through bony landmarks in the tibial plateau through to the distal tibia. Angles that may create the x-axis40 (depending upon fracture location) could be: proximal femoral angle; lateral distal femoral angle; medial proximal tibial angle; distal tibial angle.
• Now referring toFIG. 9, an X-ray view of hip anatomy within implant and grid overview is shown. In quantifying leg length discrepancy, the patient's anatomical landmark(s) can be geometrically dimensioned relative to the grid lines. For example, points on the grid line drawn through the bottom of the ischium may be viewed as points on the grid marked along theH grid line91. For example, the proximal aspect of the left lesser trochanters of the affected hip may be viewed as a point on the grid marked as G6.593 on the unaffected hip it can be determined that this same point is G5.5. For example, the distance measured counting or using the grid squares between the ischial axisgrid line H91 and the respective two lesser trochanter points (G6.5 and G5.5 for example) is the leg length discrepancy, relating to the insertedcup90.
• In another embodiment, deformity correction works much the same as the trauma description above. An existing deformity is evaluated against the patient's contralateral side. The radiolucent dimensionedgrid plate apparatus19 is used to ensure that the bone length and alignment correlate to the contralateral side. The radiolucent dimensionedgrid plate apparatus19 allows the surgeon to evaluate whether the osteotomy is sufficient to correct alignment and/or length intraoperatively, as well as making it visually easier to plan a correction procedure by using the grid to obtain pre-operative radiographs (i.e., surgeon does not have to draw his own lines and angles on plain radiographs to try to determine the appropriate amount of bone to remove and/or cut and re-angle).
• Now referring toFIGS. 10,11A, and11B, aradiolucent grid100 is shown. Theradiolucent grid100 has a plurality of dimensioned radio-opaque lines relating to surgical variables. The portion of the grid that is not opaque is radiolucent. Theradiolucent grid100 can be referred to as a radiolucent grid having a plurality of dimensioned radio-opaque lines. Theradiolucent grid100 can include any shape or pattern of geometric nature or text to reference angles, length positioning or targeting. Theradiolucent grid100 is formed of a material that can be sterilized, if desired, such as plastic or carbon fibers. Theradiolucent grid100, in one embodiment, can be placed in asealable container104, such as a bag or pouch that can be allowed to be used in a sterile field. This step can occur within a sterile environment during any surgical procedure. For example, theradiolucent grid100 is placed inside a sterile pouch, bag, orcontainer104. The sterile pouch, bag, orcontainer104 can be manufactured of any suitable material. A standard X-ray container can be sealed with theradiolucent grid100 in sterile pouch,bag104 within.
• The same protocol can be followed in a non-sterile environment before, during, and/or after any surgical event. The combination of theradiolucent grid100 within a sterile pouch, bag, orcontainer104 is referred to as thegrid plate assembly106. The radiolucent dimensionedgrid plate assembly106, in one embodiment, is positioned on top of apatient27. The surgeon can move the radiolucent dimensionedgrid plate assembly106 as fluoroscopic images are taken. The radiolucent dimensionedgrid plate assembly106 can be adjusted intraoperatively.
• Now referring toFIG. 12, disposable sterile, or non-sterile, fluoroscopic grid-drape for use intraoperatively, independent of, within, or as an integral part of C-arm drape/sleeve/cover, to determine angulation and alignment of implants and/or limbs is disclosed. This embodiment to include uses for any and all musculoskeletal surgical procedures (to include: hip replacement, knee replacement, shoulder replacement, trauma fracture repair, etc.) All embodiments include any use of theradiolucent grid100 as a disposable item.
• More specifically, in a sterile environment during any surgical procedure, aradiolucent grid100 is incorporated into a sterile disposable C-arm sleeve, pouch, bag, cover, orcontainer104. The sterile sleeve, pouch, bag, cover, orcontainer104 can be manufactured of any suitable material, such as high density polyethylene or low density polyethylene. The sleeve, pouch, bag,container104 can be sealed with theradiolucent grid100 enclosed within to form aradiolucent grid assembly106. Theradiolucent grid assembly106 can be integrated into the sleeve, pouch, bag, cover, orcontainer104 and placed over the C-arm image intensifier162 in a standard sterile manner in preparation for C-arm use. The same protocol can be followed in a non-sterile environment before, during, and/or after any surgical event.
• Now referring toFIGS. 13A and 13B: disposable, or non-disposable sterile, or non-sterile,radiolucent grid100 for use as an attachment to the C-arm image intensifier162 (or any X-ray receiver) or thetube171 is shown. Theradiolucent grid100 is attached with the use of magnets (standard or Niobium) suction cup technology (standard, Gecko, Nano suction technology)173, or any other means such as straps or clamps, and adhesives (glue, tape) or manually holding theradiolucent grid100 in place against either the X-ray image intensifier/receiver or the X-ray tube. Theradiolucent grid100 having a plurality of dimensioned radio-opaque lines relating to surgical variables is placed in a sealable radiolucent container sized to receive theradiolucent grid100 to form aradiolucent grid assembly106; and theradiolucent grid assembly106 is positioned over theC arm intensifier162 of an X-ray machine.
• Now referring toFIG. 14, a surgical positioning system made of: aradiolucent grid100 having a plurality of dimensioned radio-opaque lines corresponding to surgical variables and asubstrate127 connect to or integral with theradiolucent grid100 is shown. Thesubstrate127 can be for example an operating room table mat, operating room table, a mobile positioning device and a surgical drape. There is acentral post135 of the operating table. In one embodiment, theradiolucent grid100 is integrated into and/or manufactured within the operating room table mat or cover to from a dimensionedgrid mat122. Theradiolucent grid100 can be attached to a substrate, such as an operating room table127 or a moving table170.
• The dimensionedgrid mat122 is manufactured of foam or any operating room table material that adheres to patient comfort and safety standards. The dimensionedgrid mat122 may be fixed or connected to the substrate such as operating room table127, by any method and device to ensure secure fastening and locking of the dimensionedgrid mat122 to the operating room table127. This may include straps, VELCRO (Velcro Industries B.V.) screws, tie-downs, clamps, and any other fixation or holding jig. Further, this dimensionedgrid mat122 includes any and all geometries of operating room table designs. The dimensionedgrid mat122 may be perforated with a plurality ofapertures123 in any pattern that is conducive to allow positioning of the patient by usingpositioning devices124 of any geometry. In this embodiment, at least oneaperture123 in thegrid122 is sized to receive or accommodate apositioning device124. Thepositioning device124 projects above thetop surface128 of the mat and is configured to maintain the position of the subject relative to theradiolucent grid100 orgrid mat122. There is acentral post135 of the operating table
• The plurality ofpositioning devices124 can be used to facilitate the positioning of theradiolucent grid100 relative to thepatient27. Thepositioning device124 are rods or tubes that allow for appropriately positioning and holding the patient27 securely to allow for accurate imaging and visualization of the patient27 anatomy relative to the operating room table127 and dimensionedgrid mat122.
• Thepositioning device124 can be added to anaperture123 configured to receive thepositioning device124 or in an alternative embodiment theaperture123 is configured to accommodate thepositioning device124 and thepositioning device124 is attached to the grid and telescopes out of theaperture123.
• Now referring toFIG. 15, theradiolucent grid100 has a plurality of dimensioned radio-opaque lines integrated into and/or manufactured within the operating room table127. In this embodiment, the dimensionedgrid mat122 is connected to the operating room table127 surface by positioningdevice124 that can be manufactured with and include any and all suitable materials. In this embodiment, the operating room table127 is manufactured of any operating room table material that adheres to safety standards. The dimensionedgrid mat122 is integrated into the operating room table127 to form a grid-table assembly140. In addition, the grid-table assembly140 may be perforated in any pattern that is conducive to allow appropriate positioning of the patient27 by using positioning devices of any geometry. The operating room table127 with integratedradiolucent grid100 and positioning device can be manufactured with and include any and all suitable materials.
• As shown inFIG. 16, thepatient27 is placed on the dimensionedgrid mat122. Thepositioning devices124 are strategically placed at selected locations alongside the patient's27 body areas according to patient's27 anatomy and then secured in position within theperforations123. The plurality ofpositioning devices124 can be secured to either theradiolucent grid100 with a depression in the grid surface or by the use of a clamp or rail.
• Now referring toFIGS. 17A-C, further, this grid-table assembly140 includes any and all geometries of operating room table designs. In this embodiment, a plurality ofpegs145 can be used to facilitate a pelvic tilt orelevated mat147 that can be used for an anterior approach in order to maintain the correct pelvic orientation. Further, the grid-table assembly140 can be integrated into the design of the central peg of the operating room table127 or any extension of the operating room table used for an anterior or posterior hip approach or trauma procedure. For example, aninternal positioning peg145 can be used for adapting the basic design for other types of surgery. Thepeg145 is formed of upwardly projecting member on a base and is made of a suitable material such as plastic. The material must not be deformable.
• In another embodiment, a plurality ofpegs145 can be used to prevent a pelvic collapse during surgery and to maintain pelvic area centered on the operating room table127, while non-supported parts allow for collapse to help with the stability and comfort. The plurality ofpegs145 can be adjusted to accommodate width and the height of a patient's pelvis. A plurality ofpegs145 can be used to position aflap147 configures to form a raised area that can stabilize or immobilize a body part during surgery.
• Now referring toFIG. 18 theradiolucent grid100 may not be a complete table or is not integrated into a complete table, but is an independent extension which adapts to any operating room table127 and/or integrates into, or adapts with, amobile leg positioner170 for use in anterior or posterior hip replacement surgery. In this embodiment, acentral post apparatus155 is attached to the operating room table127 top and can be used to accommodate supplemental extensions and external apparatus with leg holding and moving functions, namely amobile leg positioner170. Thecentral post apparatus155 is part of themobile leg positioner170 and is part of themobile leg positioner170. Thecentral post apparatus155 has a cylindrical geometry strategically placed between the patient's27 legs to support the subject during surgery. Theleg holder156 is configured to hold the leg during surgery. Themobile leg positioner170 is made of aframe173 to which a plurality ofwheels171 are attached and can structurally have any design configuration that function as an adjunct, mobile, add-on, accessory, to an existing surgical table.
• Now referring toFIG. 19, is an embodiment of the invention showing an example of grid geometry pattern wherein the radio-opaque portion of the grid can be a single line, a geometrical patter, number, letter or a complex pattern of multiple lines and geometries that correspond to surgical variables. The grid patterns are predesigned based upon the surgeons knowledge of anatomy and clinical experience including interpretation of morphometric literature and studies identifying key relationships and dimensions between anatomical landmarks and its application in supporting good surgical technique as it relates to specific procedures.
• Use of radiopaque ink methods (pad, sheet printing) and technology (medical inks, metal inks, tungsten inks), or templating and stenciling methods, to print a grid pattern with surgical variables for use in any musculoskeletal surgical procedure-particularly, hip replacement, shoulder replacement, knee replacement, and all bone fracture reductions for example a tibial plateau fracture is shown. The radiopaque ink printing is applied to any suitable and appropriate substrate such as acrylic, polycarbonate, polypropylene, or polyethylene materials.
• Clinical Study Example: This retrospective cohort study reviews postoperative radiographic findings of 160 consecutive primary total hip athroplasties performed through an anterior supine approach with the aid of intraoperative fluoroscopy. The control group was 100 total hip athroplasties performed without the radiolucent dimensionedgrid plate apparatus19. The study group was 54 total hip athroplasties performed with the use of the radiolucent dimensionedgrid plate apparatus19 to aid in assessing acetabular component inclination, femoral offset, and leg length. Femoral offset, component abduction and leg length differences were measured by two readers blinded to the group status. Surgeon aims included an inclination angle of 40-45 degrees and a leg length and offset equal to the contralateral side. Additionally, the two groups were assessed for differences in demographics and clinical outcomes including complications such as dislocation and symptomatic leg length discrepancy.
• Results: Inclination angle averaged 42 degrees (SD 1.5 degrees) for the grid group compared to 45 degrees (SD 4 degrees). Femoral offset averaged +1.5 mm (SD 1 mm) compared to the contralateral side for the grid group compared to −1 mm (SD 3 mm) for the control group. Leg length differences averaged +1.5 mm (SD 1 mm) compared to the contralateral side for the grid group compared to −1 mm (SD 3 mm) for the control group.
• There were no statistically significant differences in age, gender, BMI or dislocation rate between groups. However, the group using the dimensionedgrid plate apparatus19 had a lower rate of symptomatic leg length discrepancy than the control group.
• Conclusions. While intra-operative use of fluoroscopy to guide femoral offset, leg length and acetabular inclination is helpful, a radiopaque guide with abduction angle references can be helpful to improve precision and accuracy in accomplishing the orthopedic surgeon's goals.
• While the invention has been described with reference to preferred and example embodiments, it will be understood by those skilled in the art that a variety of modifications, additions and deletions are within the scope of the invention, as defined by the following claims.

Claims (19)

1. A surgical positioning system comprising:

a radiolucent grid having a plurality of dimensioned radio-opaque lines corresponding to surgical variables and a substrate connect to or integral with the radiolucent grid.

2. The system ofclaim 1 wherein the substrate is selected from the group of: an operating room table mat, operating room table, a mobile positioning device and a surgical drape.

3. The system ofclaim 1 wherein the substrate is an operating room table mat and said grid is integrated into said operating room table mat to form a dimensioned grid mat, said dimensioned grid mat having at least one aperture in a top surface sized to accommodate a positioning device, said positioning device sized to project through and above said top surface of the dimensioned grid mat, wherein the position of a subject on said mat can be maintained in a selected position with said at least one positioning device.

4. The system ofclaim 3 further comprising an operating room table with a top surface, wherein said grid is adjacent to said operating room table top surface.

5. The system ofclaim 1 wherein the substrate is an operating room table and said grid is integrated into said operating room table to form a grid table assembly.

6. The system ofclaim 5, wherein the said operating room table mat includes at least one aperture in a top surface sized to accommodate a positioning device, said positioning device sized to project through and above said top surface of the operating room table mat, wherein the position of a subject on said surface of the grid table assembly can be maintained in a selected position with said at least one positioning device.

7. The system ofclaim 5, wherein the assembly further comprises at least one internal positioning peg contacting the operating room table and the operating room table mat to from a raised area configured to stabilize a body part of the subject.

8. The system ofclaim 1 wherein the substrate is a mobile positioning device and further comprises a leg holder device configured to hold a subject's leg in place during surgery.

9. The system ofclaim 1 further comprising an apparatus to facilitate the positioning of said grid relative to a subject, wherein said grid comprises a plurality of support plates configured to retain said grid, and wherein the apparatus to facilitate the positioning of said grid is a medial-lateral slot in said plate; and a central axis pin connected to at least one of said plurality of support plates, wherein said medial-lateral slot is configured to retain a central axis pin and to allow medial-lateral translation of the grid plate relative to a horizontal line of said support plates and to rotate around the axis of said central axis pin wherein the medial-lateral slot is comprised of a plurality countersunk grooves that are configured to retain said central axis pin.

10. An apparatus comprising:

a radiolucent grid having a plurality of dimensioned radio-opaque lines relating to surgical variables and a sealable radiolucent container sized to receive the grid.

11. The apparatus ofclaim 10 wherein said container is a C-arm cover.

12. A method to obtain subject specific data from an image of a subject obtained during a surgical procedure comprising:

providing a radiolucent grid having a plurality of dimensioned radio-opaque lines corresponding to surgical variables and a substrate connect to or integral with the radiolucent grid;

placing the subject on a substrate; and

obtaining subject specific data from an image of said subject.

13. The method ofclaim 12 wherein said wherein the data consists of: a leg length, an off-set and a cup position; and further comprising the step of adjusting the placement of a prosthetic device during an arthroplasty based on the subject specific data.

14. The method ofclaim 12 further comprising the steps of placing the radiolucent grid having a plurality of dimensioned radio-opaque lines relating to surgical variables in a sealable radiolucent container sized to receive the grid to form a grid assembly; and positioning said grid assembly over the C arm intensifier of an X-ray machine.

15. The method ofclaim 12 wherein the data consists of: obtaining of a “Y” axis corresponding to an anatomical axis of said subject and an “X” axis corresponding to an angle related to an abnormality, and further comprises the step of adjusting the orthopedic abnormality based on the subject specific data.

16. The method ofclaim 12 wherein said “x” axis is selected from the group consisting of: a proximal femoral angle, a lateral distal femoral angle, a medial proximal fibular angle and a distal tibial angle.

17. A method to print a radio-opaque grid pattern on a radiolucent substrate comprising:

printing a radio-opaque dimensioned grid corresponding to surgical variables on a radiolucent substrate.

18. The method ofclaim 17 wherein the surgical variables are selected for the group consisting of: specific reference angles, length, positioning or targeting.

19. The method ofclaim 17 wherein said substrate is a surgical drape.

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