Apparatus and procedure for blind alignment of fasteners extended through transverse holes in an orthopedic locking nail

• US 4,848,327 A
• Filed: 05/23/1988
• Issued: 07/18/1989
• Est. Priority Date: 05/23/1988
• Status: Expired due to Fees

• Current Assignee: Kevin D. Perdue
• Original Assignee: Kevin D. Perdue
• Inventors: Perdue, Kevin D.
• Primary Examiner(s): Apley, Richard J.
• Assistant Examiner(s): Bender, David J.
• Application Number:
  US07/197,216
• Time in Patent Office: 421 Days
• Field of Search: 128/92 VD, 128/92 R, 128/92 Z, 128/92 Y, 128/92 YZ, 128/92 YE, 128/305.1, 128/310, 128/316, 378/162, 378/163, 378/205, 408/72 R, 408/72 B, 408/81, 408/83, 408/87, 408/91, 408/103, 408/108, 408/115 R, 408/115 B
• US Class Current: 606/54
• CPC Class Codes: A61B 17/1703 using imaging means, e.g. by X-rays
• CPC Class Codes: A61B 17/1725 for applying transverse screws or pins through intramedullary nails or pins
• CPC Class Codes: A61B 2017/00902 transparent or translucent
• CPC Class Codes: A61B 90/39 Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: Y10T 408/5617 Laterally adjustable surface
• CPC Class Codes: Y10T 408/5635 Oppositely moving lateral clamps
• CPC Class Codes: Y10T 408/568 Guide bushing

Abstract

A method for placing screws in an orthopedic nail used in setting fractures of the long bones of the body. A fluoroscope assembly is used initially to develop an image on a monitor. This image enables the physician to adjust the fluoroscope assembly until the x-rays from the fluoroscope are propagated along lines which are coaxially aligned with the nail screw holes. This status of alignment is then used to allow reference marks to be made on the skin located on one or more lines projected through the limb containing the fractured bone in coaxial alignment with the nail screw holes.

The limb is then incised at the location of one or more of these alignment marks allowing tubular drill guides of a jig to be set against the bone in a position of coaxial alignment with the screws holes through the nail. Before using the drill guides of the jig to drill holes in the bone, precise coaxial alignment of the drill guides with the screw holes through the nail is obtained by utilizing as a part of the jig, and in fixed relation to each drill guide, an arm which carries an x-ray opaque targeting pin mounted within a relatively larger x-ray transparent disc. The targeting pins are then used to precisely align the drill guides with the nail screw holes. The drill guides then facilitate drilling holes through the bone in precise coaxial alignment with the nail screw holes. Last, locking screws are extended through the nail and screwed into the bone by the use of the drilled screw holes.

Claims

1. A device for use in directing drill holes transversely through a fractured long bone of the body in alignment with a pair of spaced, transverse holes through an elongated orthopedic nail emplaced in the medulla of the fractured long bone comprising:

an elongated channel element having first and second end portions;

a first pair of indexing standards slidably secured to one end portion of said channel element for independent sliding movement in an axial direction therealong, each of said indexing standards in said first pair including;

means for releasably locking the indexing standard at a selected fixed position along said elongated channel element;

a foot portion spaced from said channel element;

a leg connecting said foot portion to said channel element, and spacing said foot portion from said channel element; and

an elongated tubular drill guide mounted on said foot portion and extending parallel to said elongated channel element, said elongated tubular drill guides of said indexing standards in said first pair extending parallel to each other;

a second pair of indexing standards slidably secured to the second end portion of said elongated channel element for independent sliding movement in an axial direction therealong, each of said indexing standards in said second pair including;

means for releasably locking the indexing standard of said second pair at a selected fixed position along said elongated channel element;

a foot portion spaced from said channel element;

a leg connecting said foot portion to said channel element;

a pin disc of x-ray transparent material mounted in said foot portion of each one of said indexing standards in said second pair of indexing standards; and

an elongated x-ray-opaque pin mounted in the center of said pin disc and having its longitudinal axis extending parallel to said channel element, and to said tubular drill guides on the foot portions of said first pair of indexing standards, the longitudinal axis of one of said elongated pins being aligned with the longitudinal axis of one of said tubular drill guides in a line extending parallel to a line colinear with the aligned longitudinal axis of the other of said elongated pins and the other of said tubular drill guides;

said legs of said indexing standards having a length such that said foot portions will be spaced from said channel element by a distance sufficient to allow said channel element to bridge across a leg in which the fractured bone is located when said elongated pins touch the skin on one side of the leg in which the fractured bone is located, and said tubular drill guides touch the leg in which the fractured bone is located on the opposite side thereof from the side upon which said pins are located and touch the leg.

2. A device for use in directing drill holes transversely through a fractured long bone as defined in claim 1 wherein said means for releasably locking the indexing standard comprises a set screw extended through a portion of said indexing standard and against said elongated channel element to prevent further axial sliding movement along said channel element by said indexing standard.

3. A medical procedure for determined the location of a transverse fastener hole in an end of an orthopedic nail placed within the medulla of a fractured long bone of a limb in order to fix the location of the nail in the bone prior to drilling through the bone and positioning a fastener through the drill hole and the fastener hole in the orthopedic nail, said procedure comprising:

maintaining the limb and fractured bone in a fixed position;

projecting x-ray radiation through the limb, through the fractured bone and through the fastener hole in the nail, and onto an x-ray monitor;

adjusting the path of projection of the x-ray radiation relative to the limb, the bone and the orthopedic nail and the fastener hole through the nail so that the ray-image produced on said x-ray monitor visually indicates to an observer of the monitor that the projected X-ray radiation is traveling in lines which are in colinear alignment with the axis of the fastener hole in the nail;

securing and fixing the source of x-ray radiation so that the described travel of the x-ray radiation in colinear alignment will be automatically resumed and precisely reinstated at any time when the x-ray radiation is re-developed and against projected through the limb, through the fastener hole in the nail and onto the x-ray monitor;

placing indicia on the surface of the skin on the fractured limb at locations on opposite sides of the limb where the x-ray monitor indicates x-rays traveling in the described colinear alignment are entering and exiting the fractured limb, and accomplishing such visible indicia placement concurrently with the projection of x-ray radiation through the fractured limb, and using such radiation to effect such placement;

terminating the x-ray radiation while maintaining the secured, fixed position of the source of x-rays relative to the limb, bone, orthopedic nail and x-ray monitor;

placing a tubular drill guide and an elongated x-ray opaque pin in a jig in which both said drill guide and said elongated x-ray opaque pin are carried slidably on an elongated channel for movement in a direction parallel to the longitudinal axis of said elongated channel and toward and away from each other, said drill guide and elongated pin being spaced from the channel by legs which slidably support the guide and pin on the channel, and permit the channel to bridge across the limb containing the fractured bone when said tubular drill guide contacts the fractured bone on one side thereof and the elongated pin contacts the fractured limb on the other side thereof;

while said radiation is terminated, incising the skin of the fractured limb at the precise location of the indicia placed on the surface of the skin on the side of the limb facing the source of x-ray radiation to a depth of incision sufficient to permit said tubular drill guide to be directed axially through the incision and along a line extending between the indicia placed on the skin on opposite sides of the fractured limb until one end of the tubular drill guide touches the fractured one;

placing the jig relative to the limb so that the point of said elongated x-ray opaque pin touches the indicia on the opposite side of the limb from the side which faces the source of x-ray radiation, and said tubular drill guide is extended through said incision along its projected axis to a location where the tubular drill guide is fixed against, and in contact with, the fractured bone and in said incision with its axis colinear with a line projected through the hole in the nail and to the point of the elongated x-ray opaque pin;

projecting x-ray radiation from said source through the tubular drill guide and through the fastener hole in the orthopedic nail to indicate the state of alignment of the axes of the tubular drill guide and the fastener hole while the drill guide extends through the incision and into contact with the bone; and

coaxially aligning the tubular drill guide axis and the fastener hole axis by adjusting the position of the tubular drill guide as needed to achieve such coaxial alignment and as indicated by said x-ray monitor;

then

after ceasing the projection of x-rays, placing a fastener through said drill guide along its axis and into the fastener hole in the orthopedic nail along said fastener hole axis.

4. A medical procedure for determining the location of a transversely extending, elongated fastener hole in the distal end of an orthopedic nail placed within the medulla of a fractured long bone of a limb in order to fix the location of the nail in the bone prior to drilling of the bone and positioning a fastener therethrough and through said fastener hole, said procedure comprising:

maintaining the limb and fractured bone in the same position through the procedure;

beaming x-ray radiation from a source of x-rays located on one side of the fractured bone-containing limb linearly and transversely through the limb, through the fractured bone and through the fastener hole in the orthopedic nail to the side of the limb which is opposite the source of the x-rays;

adjusting the position of the source of x-ray radiation relative to the limb, the bone and the nail so that an x-ray image produced on an x-ray monitor visually indicates that the projected x-ray radiation is traveling in colinear alignment with the axis of said elongated fastener hole in the nail;

placing indicia on the skin of the limb at locations on opposite sides of the limb, using said x-ray monitor in conjunction with projected x-rays from said source to indicate when said x-rays are traveling in colinear alignment between said indicia and the axis of the elongated fastener hole in the nail as the x-rays enter, pass through and exit from the fractured limb;

positioning adjacent the limb an x-ray opaque pin having a diametric size less than the size of the diameter of the nail fastener hole so that said pin is aligned with said indicia marked on the limb on opposite sides of the limb, with said pin contacting the indicia which has been marked on the limb opposite the source of said x-ray radiation;

prior to said positioning of said opaque pin, adjustably fixing the spacial and geometric relationship of said opaque pin to a tubular drill guide by placing both pin and drill guide in a jig usable to adjust and set the distance of the drill guide from the pin along the projected axis of the tubular drill guide;

incising the skin of the limb at the indicia positioned on the side of the limb facing the source of x-rays, and opposite the side upon which said pin is located with said incising being carried out in a direction and to a depth sufficient to permit the tubular drill guide to be directed axially through the incision and along a line between the indicia placed on the skin on opposite sides of the limb until one end of the tubular drill guide touches the fractured bone;

fixing said tubular drill guide against the fractured bone and in said incision while the drill guide axis is in substantially alignment with the axis of the fastener hole;

projecting x-ray radiation from said source through the tubular drill guide and through the fastener hole in the orthopedic nail and against the x-ray monitor to indicate on the monitor the state of alignment of the axes of the drill guide, fastener hole and opaque pin while the drill guide extends through the incision into contact with the bone; and

coaxially aligning the tubular drill guide axis, the fastener hole axis and said opaque pin by adjusting the position of the drill guide as needed and as indicated by said x-ray monitor;

then

using the described alignment to place the fastener through the fastener hole in the orthopedic nail and into the fractured bone on opposite sides of the orthopedic nail.

5. The medical procedure of claim 4 and further characterized as comprising:

fixing the source of the x-ray radiation prior to placing the indicia on the skin so that the x-ray radiation travels in colinear alignment with the axis of said fastener hole in the orthopedic nail and will repeatedly travel in such colinear alignment when the x-ray radiation is re-developed and re-projected after having once been terminated, as long as said source is so fixed; and

terminating the x-ray radiation after placing the indicia on the skin while maintaining the fixed position of the source relative to the limb, the bone and the orthopedic nail.

6. A device for use in directing drill holes transversely through a fractured long bone of a limb in directional alignment with a pair of spaced, transverse holes through an elongated orthopedic nail implaced in the medulla of the fractured long bone, said device comprising:

an elongated channel element having first and second end portions;

a first pair of indexing standards slidably secured to one end portion of said channel element for independent sliding movement in an axial direction therealong and each including drill guiding means carried thereon; and

second pair of indexing standards slidably secured to the second end portion of said elongated channel element for independent sliding movement in an axial direction therealong, said second pair of indexing standards including;

a pin disc of x-ray transparent material mounted on each one of said indexing standards in said second pair of indexing standards; and

an elongated x-ray opaque pin mounted in the center of each said pin discs and each having its longitudinal axis extending parallel to said channel element.

7. The device of claim 6 wherein each of said indexing standards in said first pair includes:

a foot portion spaced from said channel element;

a leg connecting said foot portion to said channel element, and spacing said foot portion from said channel element; and

an elongated tubular drill guide constituting said drill guiding means mounted on said foot portion and extending parallel to said elongated channel element, said elongated tubular drill guides of said indexing standards in said first pair of indexing standards extending parallel to each other;

and wherein each of said second pair of indexing standards includes;

a second pair of foot portions spaced from said channel element;

a second pair of legs connecting said second pair of foot portions to said channel element; and

each one of said elongated x-ray opaque pins having its longitudinal extending parallel to said channel element, and to said tubular drill guides on the foot portions of said first pair of indexing standards, the longitudinal axis of each one of said elongated pins being aligned with the longitudinal axes of said tubular drill guides; and

said legs of said indexing standards having a length such that said foot portions will be spaced along said channel element by a distance sufficient to allow said channel element to bridge across a fractured leg in which the fractured bone is located when said elongated pins touch the skin on one side of the fractured leg in which the fractured bone is located, and said tubular drill guides touch the fractured leg in which the fractured bone is located on the opposite side thereof from the side upon which said pins are located and touch the fractured leg.

8. The device of claim 7 wherein each of said first pair of indexing standards and each of the second pair of indexing standards further includes means for releasably and independently locking the indexing standards at selected fixed positions along said elongated channel element.

9. A device for use in directing a drill hole transversely through a fractured long bone of a limb so that such drill hole is in alignment with a transverse hole through an elongated orthopedic nail implaced in the medulla of the fractured long bone, said device comprising:

an elongated guide element having a first end portion and a second end portion;

at least one first indexing standard supported on one end portion of said guide element for sliding movement in an axial direction therealong, said first indexing standard projecting normal to the longitudinal axis of said elongated guide element and comprising;

a first foot portion supported by the elongated guide element in a position spaced from said guide element; and

an elongated tubular drill guide mounted on said foot portion and extending parallel to said elongated guide element;

at least one additional indexing standard supported on an opposed second end portion of said elongated guide element for sliding movement in an axial direction therealong, said additional indexing standard extending normal to said elongated guide element and comprising;

a second foot portion supported in a position spaced from said elongated guide element;

a pin disc of x-ray transparent material mounted on said foot portion of said additional indexing standard; and

an elongated x-ray opaque pin mounted in the center of said pin disc and having its longitudinal axis extending parallel to said elongated guide element, and to said tubular drill guide on the first foot portion on said first indexing standard, the longitudinal axis of said elongated pin being aligned with the longitudinal axis of said tubular drill guide.

10. The device of claim 9 wherein said first indexing standard further comprises:

means for releasably locking said first indexing standard at a selected fixed position along said elongated guide element;

a first leg disposed between said first foot portion and said guide element for spacing said first foot portion from said guide element; and

wherein said additional indexing standard further comprises;

means for releasably locking the additional indexing standard at a selected fixed position along said elongated guide element; and

a second leg disposed between said second foot portion and said guide element for spacing said second foot portion from said guide element.

11. A device for use in directing drill holes transversely through a fractured long bone of the body in alignment with a spaced, transverse hole extending through an elongated orthopedic nail placed in the medulla of the fractured long one, said device comprising:

an elongated guide element having a first end portion and a second end portion;

a first indexing standard movably secured to said first end portion of said guide element for movement in an axial direction therealong, said first indexing standard including;

means for locking the first indexing standard at a selected position along the elongated guide element;

first spacing means secured to said elongated guide element and extending normal to said elongated guide element; and

an elongated tubular drill guide mounted on said first spacing means and extending parallel to said elongated guide element, said elongated tubular drill guide being positioned at a location spaced from said elongated guide element;

a second indexing standard movably secured to the second end portion of said elongated guide element for movement in an axial direction therealong, said second indexing standard including;

means for locking the second indexing standard at a fixed position along said elongated guide element;

second spacing means secured to said elongated guide element and extending normal to said elongated guide element;

a pin disc of x-ray transparent material mounted on said second spacing means; and

an elongated x-ray opaque pin mounted in the center of said pin disc and having its longitudinal axis extending parallel to said guide element and in alignment with the longitudinal axis of said tubular drill guide carried on said first spacer means of said first indexing standard;

said first and second spacing means of said first and second indexing standards each having a length such that the tubular drill guide and the pin disc and elongated x-ray opaque pin will be spaced from said guide element by a distance sufficient to allow said guide element to bridge across a leg in which the fractured bone is located when said elongated pin touches the skin on one side of the leg in which the fractured bone is located, and said tubular drill guide touches the leg in which the fractured bone is located on the opposite side thereof from the side upon which said pin is located and touches the leg.

12. A medical procedure for extending a fastening element through a transverse fastener hole in the distal end of an orthopedic nail placed within the medulla of a fractured long bone of the body to fix the location of the nail in the bone, said procedure comprising:

projecting x-ray radiation from a source on one side of the fractured bone-containing limb linearly transversely through the fractured bone and through the fastener hole in the nail and through the limb to the side thereof opposite the source of the x-rays while maintaining the fractured limb and fractured bone immobilized and in a fixed position;

adjusting the position of the source of x-ray radiation relative to the limb, bone and nail so that the x-ray image produced on an x-ray monitor visually indicated that the projected x-ray radiation is traveling in colinear alignment with the axis of said fastener hole in the nail;

fixing the source of x-ray radiation so that said travel in colinear alignment is maintained as long as the x-ray radiation is developed and projected;

placing visible indicia on the skin of the fractured limb at locations on opposite sides of the limbs where the x-ray monitor indicates x-rays traveling in said colinear alignment are entering and exiting from the fractured limb after passing through the fastener hole, and accomplishing such visible indicia placement concurrently with the projection of x-ray radiation through the fractured limb;

terminating the x-ray radiation while maintaining the fixed position of the source relative to the limb, bone and nail;

locating in a jig in adjustable spacial and geometric relationship to each other, (a) an x-ray opaque pin of smaller diametric size than the diameter of the fastener hole in the nail, with said pin being located in the center of an x-ray transparent disc, and (b) a tubular drill guide having its longitudinal axis aligned by the jig with said x-ray opaque pin and adjustable toward and away from said pin along said axis as both are mounted in said jig;

incising the skin of the fractured limb at one of the visible indicia made thereon on one side of the limb to a depth sufficient to permit a tubular drill guide to be directed axially through the incision, and along a line between the visible indicia placed on the skin on opposite sides of the fractured limb until one end of the tubular drill guide touches the fractured bone;

located said x-ray opaque pin at the precise location where said visible indicia has been marked on the opposite side of said limb from said incision;

fixing said tubular drill guide in said incision and against the fractured bone;

fixing the drill guide and opaque pin in their relationship to each other;

projecting x-ray radiation from said source through the tubular drill guide and through the fastener hole to indicate the state of alignment of the axes of the tubular drill guide and the fastener hole while the drill guide extends through the incision into contact with the bone;

coaxially aligning the tubular drill guide axis and the fastener hole axis by adjusting the position of the drill guide relative to the bone as needed, and as indicated by said x-ray monitor;

drilling into the bone through the tubular drill guide so that the hole drilled in the bone is coaxially aligned with the axes of the tubular drill guide and the fastener hole; and

extending a fastener through the drill hole in the bone and through the fastener hole in the orthopedic nail to fasten the nail at a fixed location in the bone.

13. A medical procedure as defined in claim 12 including the preliminary step of including said drill guide and elongated pin in a jig in which both the drill guide and the elongated pin are carried slidably on an elongated channel for movement in a direction parallel to the longitudinal axis of said elongated channel and toward and away from each other, said drill guide and elongated pin being spaced from the channel by legs which slidably support the drill guide and pin on the channel, and permit the channel to bridge across the limb containing the fractured bone when said tubular drill guide contacts the fractured bone on one side thereof and the elongated pin contacts the limb on the other side thereof.

14. A medical procedure for extending a fastening element through a transverse fastener hole in the distal end of an orthopedic nail placed within the medulla of a fractured long bone of the body to fix the location of the nail in the bone, said procedure comprising:

projecting x-ray radiation from a source on one side of the fractured bone-containing limb linearly transversely through the fractured bone and through the fastener hole in the nail and through the limb to the side thereof opposite the source of the x-rays while maintaining the limb and fractured bone immobilized in a fixed position;

adjusting the position of the source of x-ray radiation relative to the limb, bone and nail so that the x-ray image produced on an x-ray monitor visually indicates that the projected x-ray radiation is traveling in colinear alignment with the axis of said fastener hole in the nail;

fixing the source of x-ray radiation so that said travel in colinear alignment continues when the x-ray radiation is developed and projected;

placing visible indicia on the skin of the fractured limb at locations on opposite sides of the limb where the x-ray monitor indicates x-rays traveling in said colinear alignment are entering and exiting from the fractured limb, and accomplishing such visible indicia placement concurrently with the projection of x-ray radiation through the fractured limb;

terminating the x-ray radiation while maintaining the fixed position of the source relative to the limb, bone and nail;

locating in a jig in adjustable spacial and geometric relationship to each other, (a) an x-ray opaque pin of smaller diametric size than the diameter of the fastener hole in the nail, with said pin being located in the center of an x-ray transparent disc, and (b) a tubular drill guide having its longitudinal axis aligned by the jig with said x-ray opaque pin, and adjustable toward and away from said pin along said axis as both are mounted in said jig;

incising the skin of the fractured limb at one of the indicia made thereon on one side of the limb to a depth sufficient to permit a tubular drill guide to be directed axially through the incision, and along a line between the visible indicia placed on the skin on opposite sides of the fractured limb until one end of the tubular drill guide touches the fractured bone;

locating said x-ray opaque pin at the precise location where said visible indicia has been marked on the opposite side of said limb from said incision;

fixing said tubular drill guide against the fractured bone in said incision;

setting the drill guide and opaque pin in their relationship to each other;

drilling into the bone through the tubular drill guide so that the hole drilled into the bone is coaxially aligned with the axes of the tubular drill guide and fastener hole by reason of the tubular drill guide being set colinearly along a line between the visible indicia on one side of the limb, and the location of the point of the x-ray opaque pin against the visible indicia on the opposite side of the limb; and

extending a fastener through the drill hole in the bone and through the fastener hole in the orthopedic nail to fasten the nail at a fixed location in the bone.