SURGICAL ALIGNMENT SYSTEM, APPARATUS AND METHOD OF USE

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 to FIG. 1 a radiolucent dimensioned grid plate 1 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 dimensioned grid plate 1 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 to FIG. 2, a radiolucent dimensioned grid plate 1 for hip arthroplasty is provided. The radiolucent dimensioned grid plate 1 is “sandwiched” between support plates 4 that have an extended aspect 6 in the caudal direction, to form the radiolucent dimensioned grid plate apparatus 19. This caudal aspect has a cutout 5 that matches and mates with an operating room table's peg for use in an anterior approach procedure. The outer layer of the support plates 4 are joined together at the corners 15 by a solid metal piece that will also serve as the attachment place for the clamps that will attach the a radiolucent dimensioned grid plate apparatus 19 to the operating room table 72 or to the hip positioning apparatus (not shown). For strength, support rods (not shown) can be added to the caudal aspect.

In this radiolucent dimensioned grid plate 1, two grid lines form a V and are angled at 45 degrees to the vertical and horizontal. In this dimensioned grid plate 1, these two lines represent a guide 3 for quantifying the abduction angle of an acetabular cup used during an arthroplasty procedure. However, the desired angle for the guide 3 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 dimensioned grid plate apparatus 19 is a mirror image of the right hand side. The radiolucent dimensioned grid plate 1 can have the following radio opaque markings (any and all methods of etching or marking): Two 45 degree angled radio opaque guide lines 3; two elliptical etchings which represent the proper version of the acetabular component 8 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 zero 10; 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 dimensioned grid plate 1 can be enclosed on either side in an epoxy resin that is both transparent and with a plurality of support plates 4 to form the radiolucent dimensioned grid plate apparatus 19. The epoxy creates a complete seal for the metal to prevent corrosion and support cleanability of the radiolucent dimensioned grid plate apparatus 19. 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 on support plates 4; 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 on support plates 4.

Now referring to FIGS. 3, 4A and 4B, a plurality of support plates 4 is shown surrounding the dimensioned grid plate 1. This central axis pin 11 is attached to the outer support plates 4 by conventional means such as a screw threaded through the support plate into the end of the central axis pin 11. The central axis pin 11 is captured on either end by a screw threaded through the support plates 4 and into the end of the axis pin—on both ends. A medial-lateral slot 13 allows a +/−5 cm medial-lateral translation of the dimensioned grid plate 1 relative to the support plates 4. The central axis pin 11 is oriented perpendicularly to the surface of the plurality of support plates 4 and the central axis pin 11 projects upwardly. This dimensioned grid plate 1 has a slot 13. The slot 13 allows the dimensioned grid plate 1 to be shifted from side to side or medially-laterally.

Now referring to FIGS. 4A and 4B, the dimensioned grid plate 1 articulates within the support plates 4 by a central axis pin 11. The medial-lateral slot 13 allows +/−5 cm medial-lateral translation of the dimensioned grid plate 1 relative to the support plates 4 and the patient 27. The radiolucent dimensioned grid plate 1 can also be rotated +/−40 degrees about the central axis pin 11 axis relative to the support plates 4 and the patient 27. The radiolucent dimensioned grid plate 1 is rotated or translated by using the handle 12 that is attached to the radiolucent dimensioned grid plate apparatus 19. The radiolucent dimensioned grid plate 1 rotates about the central axis pin 11.

The slot 13 is configured with scalloped sides or edges that allow the radiolucent dimensioned grid plate 1 to be indexed at a plurality of positions. The central axis pin 11 has a central axis pin groove 21 about which the radiolucent dimensioned grid plate 1 will rotate. The central axis pin groove 21 will further have a series of countersunk grooves 22 for engagement of spring-loaded ball 23 (for location of rotational position of the dimensioned grid plate 1 relative to the outer support plates. Furthermore, the radiolucent dimensioned grid plate 1 translates in a medial lateral direction along the central axis pin 11. This translational movement is achieved by utilizing countersunk grooves 26 with a spring-loaded device (SLD) 24 having a uniform groove and countersunk slot configuration. The indexing is accomplished by a translation/rotational mechanism 25. The central axis pin 11 has the ability to translate along the medial-lateral slot 13 and engage in any one of a series of positions in the medial lateral direction. This is accomplished by having a plurality of spring-loaded device 25 used in conjunction with a plurality of corresponding countersunk slots 26. This rotation is accomplished by the configuration of the medial lateral slot 13.

The slot 13 is made of a plurality countersunk grooves 26 that are configured to retain the central axis pin 11. Additionally, the surface opposite 30 one of the plurality of countersunk grooves 26 is configured to retain a spring-loaded device 24. A plurality of spring-loaded devices 24 mediate the movement of the radiolucent dimensioned grid plate 1. The spring-loaded device 25 releasably holds the central axis pin 11 in the selected scalloped or notched position. The engagement/disengagement position and force will be determined based upon spring-loaded device holding capacity. The central axis pin 11 can be fluted longitudinally 22 which allows a rotational detent action as the patient (on the radiolucent dimensioned grid plate apparatus 19) is rotated in the horizontal plane about the central axis pin 11.

Now referring to FIG. 5, on the underside of the radiolucent dimensioned grid plate apparatus 19 there are strips of an adhesive material such as VELCRO (Velcro Industries B.V.) 17 to further secure the plate to the operating room table 72. This prevents the radiolucent dimensioned grid plate apparatus 19 from moving relative to the operating room table or patient during the surgical procedure. In another embodiment, the radiolucent dimensioned grid plate apparatus 19 can include posts 18 to attach to an operating room table 72. The dimensioned grid plate 1 does not need to be secured and can be used in a “free-hand” technique where the radiolucent dimensioned grid plate apparatus 19 is simply held in position—this includes holding the radiolucent dimensioned grid plate apparatus 19 above the patients pelvis or holding a radiolucent dimensioned grid plate apparatus 19 up in front of the fluoro image on the X-ray machine. It should be noted that the radiolucent dimensioned grid plate apparatus 19 is disposable or resterilizable.

Now referring to FIGS. 6A and 6B, this embodiment allows for use in all surgical approaches to the hip. For the anterior approach, the dimensioned grid plate apparatus 19 is used as shown in FIG. 6A, the patient is in a supine position with the radiolucent dimensioned grid plate apparatus 19 placed beneath the patient's pelvis. For the posterior approach as shown in FIG. 6B. The added benefit is having the ability to rotate, translate ML, and ideally position the grid to the anatomy of the patient. The dimensioned grid plate 1 has the ability to rotate +/−40 degrees from the vertical and translate in the medial lateral direction +/−5 cm. The radiolucent dimensioned grid plate 1 can translate cephalad/caudad by adjusting the clamps which fix the radiolucent dimensioned grid plate apparatus 19 to the bed or the hip positioning device.

The dimensioned grid plate apparatus 19 can also be used for an anterior approach procedure. The Hilgenreiner's line 31 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 dimensioned grid plate apparatus 19 has an extension in the caudad direction that has enough distance to allow the grid to lock onto the operating room table 72 and then also ensure that the radiolucent dimensioned grid plate apparatus 19 is directly behind (posterior) the patient's 27 pelvis. The extension piece has a slot or cut out 5 that matches the diameter of the peg (not shown) on the operating room table 72 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 dimensioned grid plate apparatus 19 relative to the patient 27 during the surgery. In testing that was performed, tables that are conducive to the direct anterior approach were used. The radiolucent dimensioned grid plate apparatus 19 and method can be used on any radiolucent operating room table.

For a posterior surgical approach, FIG. 6B, the patient 27 is placed in the appropriate position for hip replacement surgery. The surgeon places the patient 27 in a Lateral Decubitus position; the surgeon positions the radiolucent dimensioned grid plate apparatus 19 directly behind the pelvis of the patient 27. 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 patient 27 can be placed on the patient's 27 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 dimensioned grid plate apparatus 19 as an alignment and measurement device. The radiolucent dimensioned grid plate apparatus 19 has a 45 degree angled metal line 3. The radiographic image will display the trial or final implanted acetabular cup positioned in the acetabulum relative to the 45 degree guide line 3 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 to FIGS. 7 and 8, a radiolucent dimensioned grid plate apparatus 19 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 at 40 is determined. Next the distal femoral angle is determined at 42 Next the proximal tibial angle 46 is determined Next the distal tibial angle 43 is determined to form the “X” axis relative to the “Y” axis 35 of the dimensioned grid plate apparatus 19.

The Y axis 35 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 a right leg application 49 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 the femoral head point 49. These same lines can also be used to quantify femoral neck angle 51. The knee section 48 is made of a grid pattern matching that of radiolucent dimensioned grid plate apparatus 19. Similarly, the ankle section 47 is made of a grid pattern matching that of radiolucent dimensioned grid plate apparatus 19. The knee section has a central x-axis 42. Similarly, the ankle section 47 has central x-axis 43. The knee grid section 48 has two 3 degree lines 46 for use in quantifying alignment as needed.

In another embodiment, and now referring to FIG. 8, a radiolucent dimensioned grid plate apparatus 19 for use with a trauma procedure on a lower extremity is disclosed. The trauma implications go beyond the pelvis and acetabulum. A larger radiolucent dimensioned grid plate apparatus 19 that runs from the patient's pelvis to beyond the ankle allows a surgeon to confirm length using the contralateral side. Additionally, the radiolucent dimensioned grid plate apparatus 19 allows the surgeon to confirm alignment prior to and after placement of an implant. The y-axis 35 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-axis 40 (depending upon fracture location) could be: proximal femoral angle; lateral distal femoral angle; medial proximal tibial angle; distal tibial angle.

Now referring to FIG. 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 the H grid line 91. 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 G6.5 93 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 axis grid line H 91 and the respective two lesser trochanter points (G6.5 and G5.5 for example) is the leg length discrepancy, relating to the inserted cup 90.

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 dimensioned grid plate apparatus 19 is used to ensure that the bone length and alignment correlate to the contralateral side. The radiolucent dimensioned grid plate apparatus 19 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 to FIGS. 10, 11A, and 11B, a radiolucent grid 100 is shown. The radiolucent grid 100 has a plurality of dimensioned radio-opaque lines relating to surgical variables. The portion of the grid that is not opaque is radiolucent. The radiolucent grid 100 can be referred to as a radiolucent grid having a plurality of dimensioned radio-opaque lines. The radiolucent grid 100 can include any shape or pattern of geometric nature or text to reference angles, length positioning or targeting. The radiolucent grid 100 is formed of a material that can be sterilized, if desired, such as plastic or carbon fibers. The radiolucent grid 100, in one embodiment, can be placed in a sealable container 104, 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, the radiolucent grid 100 is placed inside a sterile pouch, bag, or container 104. The sterile pouch, bag, or container 104 can be manufactured of any suitable material. A standard X-ray container can be sealed with the radiolucent grid 100 in sterile pouch, bag 104 within.

The same protocol can be followed in a non-sterile environment before, during, and/or after any surgical event. The combination of the radiolucent grid 100 within a sterile pouch, bag, or container 104 is referred to as the grid plate assembly 106. The radiolucent dimensioned grid plate assembly 106, in one embodiment, is positioned on top of a patient 27. The surgeon can move the radiolucent dimensioned grid plate assembly 106 as fluoroscopic images are taken. The radiolucent dimensioned grid plate assembly 106 can be adjusted intraoperatively.

Now referring to FIG. 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 the radiolucent grid 100 as a disposable item.

More specifically, in a sterile environment during any surgical procedure, a radiolucent grid 100 is incorporated into a sterile disposable C-arm sleeve, pouch, bag, cover, or container 104. The sterile sleeve, pouch, bag, cover, or container 104 can be manufactured of any suitable material, such as high density polyethylene or low density polyethylene. The sleeve, pouch, bag, container 104 can be sealed with the radiolucent grid 100 enclosed within to form a radiolucent grid assembly 106. The radiolucent grid assembly 106 can be integrated into the sleeve, pouch, bag, cover, or container 104 and placed over the C-arm image intensifier 162 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 to FIGS. 13A and 13B: disposable, or non-disposable sterile, or non-sterile, radiolucent grid 100 for use as an attachment to the C-arm image intensifier 162 (or any X-ray receiver) or the tube 171 is shown. The radiolucent grid 100 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 the radiolucent grid 100 in place against either the X-ray image intensifier/receiver or the X-ray tube. The radiolucent grid 100 having a plurality of dimensioned radio-opaque lines relating to surgical variables is placed in a sealable radiolucent container sized to receive the radiolucent grid 100 to form a radiolucent grid assembly 106; and the radiolucent grid assembly 106 is positioned over the C arm intensifier 162 of an X-ray machine.

Now referring to FIG. 14, a surgical positioning system made of: a radiolucent grid 100 having a plurality of dimensioned radio-opaque lines corresponding to surgical variables and a substrate 127 connect to or integral with the radiolucent grid 100 is shown. The substrate 127 can be for example an operating room table mat, operating room table, a mobile positioning device and a surgical drape. There is a central post 135 of the operating table. In one embodiment, the radiolucent grid 100 is integrated into and/or manufactured within the operating room table mat or cover to from a dimensioned grid mat 122. The radiolucent grid 100 can be attached to a substrate, such as an operating room table 127 or a moving table 170.

The dimensioned grid mat 122 is manufactured of foam or any operating room table material that adheres to patient comfort and safety standards. The dimensioned grid mat 122 may be fixed or connected to the substrate such as operating room table 127, by any method and device to ensure secure fastening and locking of the dimensioned grid mat 122 to the operating room table 127. This may include straps, VELCRO (Velcro Industries B.V.) screws, tie-downs, clamps, and any other fixation or holding jig. Further, this dimensioned grid mat 122 includes any and all geometries of operating room table designs. The dimensioned grid mat 122 may be perforated with a plurality of apertures 123 in any pattern that is conducive to allow positioning of the patient by using positioning devices 124 of any geometry. In this embodiment, at least one aperture 123 in the grid 122 is sized to receive or accommodate a positioning device 124. The positioning device 124 projects above the top surface 128 of the mat and is configured to maintain the position of the subject relative to the radiolucent grid 100 or grid mat 122. There is a central post 135 of the operating table

The plurality of positioning devices 124 can be used to facilitate the positioning of the radiolucent grid 100 relative to the patient 27. The positioning device 124 are rods or tubes that allow for appropriately positioning and holding the patient 27 securely to allow for accurate imaging and visualization of the patient 27 anatomy relative to the operating room table 127 and dimensioned grid mat 122.

The positioning device 124 can be added to an aperture 123 configured to receive the positioning device 124 or in an alternative embodiment the aperture 123 is configured to accommodate the positioning device 124 and the positioning device 124 is attached to the grid and telescopes out of the aperture 123.

Now referring to FIG. 15, the radiolucent grid 100 has a plurality of dimensioned radio-opaque lines integrated into and/or manufactured within the operating room table 127. In this embodiment, the dimensioned grid mat 122 is connected to the operating room table 127 surface by positioning device 124 that can be manufactured with and include any and all suitable materials. In this embodiment, the operating room table 127 is manufactured of any operating room table material that adheres to safety standards. The dimensioned grid mat 122 is integrated into the operating room table 127 to form a grid-table assembly 140. In addition, the grid-table assembly 140 may be perforated in any pattern that is conducive to allow appropriate positioning of the patient 27 by using positioning devices of any geometry. The operating room table 127 with integrated radiolucent grid 100 and positioning device can be manufactured with and include any and all suitable materials.

As shown in FIG. 16, the patient 27 is placed on the dimensioned grid mat 122. The positioning devices 124 are strategically placed at selected locations alongside the patient's 27 body areas according to patient's 27 anatomy and then secured in position within the perforations 123. The plurality of positioning devices 124 can be secured to either the radiolucent grid 100 with a depression in the grid surface or by the use of a clamp or rail.

Now referring to FIGS. 17A-C, further, this grid-table assembly 140 includes any and all geometries of operating room table designs. In this embodiment, a plurality of pegs 145 can be used to facilitate a pelvic tilt or elevated mat 147 that can be used for an anterior approach in order to maintain the correct pelvic orientation. Further, the grid-table assembly 140 can be integrated into the design of the central peg of the operating room table 127 or any extension of the operating room table used for an anterior or posterior hip approach or trauma procedure. For example, an internal positioning peg 145 can be used for adapting the basic design for other types of surgery. The peg 145 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 of pegs 145 can be used to prevent a pelvic collapse during surgery and to maintain pelvic area centered on the operating room table 127, while non-supported parts allow for collapse to help with the stability and comfort. The plurality of pegs 145 can be adjusted to accommodate width and the height of a patient's pelvis. A plurality of pegs 145 can be used to position a flap 147 configures to form a raised area that can stabilize or immobilize a body part during surgery.

Now referring to FIG. 18 the radiolucent grid 100 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 table 127 and/or integrates into, or adapts with, a mobile leg positioner 170 for use in anterior or posterior hip replacement surgery. In this embodiment, a central post apparatus 155 is attached to the operating room table 127 top and can be used to accommodate supplemental extensions and external apparatus with leg holding and moving functions, namely a mobile leg positioner 170. The central post apparatus 155 is part of the mobile leg positioner 170 and is part of the mobile leg positioner 170. The central post apparatus 155 has a cylindrical geometry strategically placed between the patient's 27 legs to support the subject during surgery. The leg holder 156 is configured to hold the leg during surgery. The mobile leg positioner 170 is made of a frame 173 to which a plurality of wheels 171 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 to FIG. 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 dimensioned grid plate apparatus 19. The study group was 54 total hip athroplasties performed with the use of the radiolucent dimensioned grid plate apparatus 19 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 dimensioned grid plate apparatus 19 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

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

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