WO2005027759A1

WO2005027759A1 - Percutaneous scaphoid fixation method and guide wire alignment device

Info

Publication number: WO2005027759A1
Application number: PCT/US2003/026380
Authority: WO
Inventors: Frederic C. Feiler; Mitchell B. Rotman
Original assignee: Feiler Frederic C
Priority date: 2003-08-22
Filing date: 2003-08-22
Publication date: 2005-03-31
Also published as: AU2003260012A1

Abstract

A method and associated apparatus for percutaneous internal fixing of a fractured limb bone comprising, placing the limb in a stabilizing clamp (2) that is, transparent to x-ray radiation, demonstrating the fractured bone, resolving the course through the fractured bone of an intended fixation device, inserting a guide wire (32) along the resolved course and across the fracture faces of the bone through an alignment conduit (28) in the stabilizing clamp, drilling a pilot hole in the bone through the fracture faces by directing a cannulated drill (40) over the guide wire, and introducing a cannulated fastening screw (44) within the drilled pilot hole and across the bone fracture site.

Description

PERCUTANEOUS SCAPHOID FIXATION METHOD AND GUIDE WIRE ALIGNMENT DEVICE

[0001] This application is a continuation-in-part of U.S. Application No.

09/693,580, filed October 20, 2000. The present invention relates to surgical

methods and devices for fixation of broken bones and in particular to the

percutaneous fixation of a fractured scaphoid bone in the human wrist,

BACKGROUND

[0002] The boat shaped scaphoid bone in the human wrist is the largest bone

of the proximal row of the carpus on the lateral (radial) side, articulating with

the radius, lunate, capitate, trapezium, and trapezoid. The scaphoid is

surrounded on 80% of its surface by joint fluid containing fibrinolysin, a

substance that dissolves blood clots.

[0003] The scaphoid is frequently fractured in young adults through the mid-

portion, or "waist" of the bone. Because blood clots are necessary for the

healing of bone fractures, the substantial presence of fibrinolysin around the

scaphoid inhibits healing of a fracture of that bone unless the fracture fragments

are in sufficiently good apposition that joint fluid is prevented from entering the

fracture site. Failure to properly fix the bone fragments into apposition will

result in a non-union because of the presence in the fracture site of joint fluid.

[0004] In addition to an undesirable non-union, resulting from poor

apposition, a fracture of the scaphoid through its waist often leads to avascular

necrosis or death of the distal pole of the bone. This is because the blood

supply to the bone is chiefly through the proximal pole and an unhealed fracture at the bone waist cuts off the blood supply to the distal pole, resulting

eventually in severe arthritis and deformity of the wrist.

[0005] The traditional conservative treatment of a fractured scaphoid

includes the application of a cast to the hand and thumb with the hand in radial

deviation in an effort to oppose the fracture ends of the bone. Surgical

intervention to fix the scaphoid bone typically includes the use of a screw that

requires the expertise of a hand surgeon specialist and is a tedious and difficult

exposure of the scaphoid bone.

[0006] The percutaneous method and the device of the present invention will

allow a less experienced hand surgeon or an orthopedist to fix a scaphoid

fracture with a lag screw. Such simplification of the procedure lead's to good

apposition of the bone fragments and an overall improved result, including the

minimization of surgical exposure of the wrist.

SUMMARY OF THE INVENTION

[0007] The present invention provides a simple percutaneous method that

incorporates a novel appliance to promote the procedure. The essence of the

method is to accurately resolve the required course of a fixation device, such as

a lag screw, and to be able to implant the device along the desired course.

[0008] The scaphoid bone is disposed in the wrist at a compound angle that

is demonstrated only with an anterior-posterior x-ray and a lateral x-ray of the

wrist. Even with the assistance of these x-ray, it is difficult to insert a fixation

device that will follow the desired course into the scaphoid bone without substantial surgical intervention, accompanied by possible multiple attempts, or

without the aid of an alignment jig, such as the one of the present invention.

The apparatus of the present invention comprises a clamp or vise-like device

having a pair of opposed relatively movable jaws between which the wrist

containing the fractured scaphoid is inserted. Upon closing the jaws of the vise

over the dorsal and palmar sides of the wrist, it is held in position so that A-P

and lateral view x-rays may be taken. From these x-rays, the desired course of

a fixation device may be resolved, including visualization of the angle of the

scaphoid, as shown on the A-P view, and its vertical angulation, as shown on

the lateral view. Once the course is determined, the single one of a plurality of

bore holes in the lower jaw of the vice that is most closely aligned with the

desired course is chosen for aligning and positioning a guide wire. Using the

chosen bore to support and direct the guide wire, the wire is drilled through

skin and subcutaneous tissue into the scaphoid bone, along the direction and at

the angle imposed by the aligning bore.

[0009] Once the guide wire is drilled into the bone, the wrist is removed

from the clamping vise. A small longitudinal incision is made in the tissue on

either side of the guide wire and that tissue is then spread in order to

accommodate the bit of a drill and the lag screw that will be inserted into the

bone.

[0010] A cannulated drill bit is passed over the guide wire and a hole coaxial

with the wire is drilled to terminate near the proximal end of the scaphoid bone. Following removal of the drill, a cannulated lag screw of appropriate length is

passed over the guide wire and screwed into the bone, bringing the fracture

fragments snugly together in good apposition. The spread tissue is allowed to

retract, the guide wire is removed and the incision is closed with a few sutures.

[0011] The bone apposition achieved by the accurately placed and well

fitted lag screw prevents joint fluid from entering the fracture site and

dissolving the blood clots that are necessary for bone union.

DESCRIPTION OF THE DRAWINGS

[0012] Figure 1 is a perspective view of the clamping and guide wire

alignment apparatus of the present invention.

[0013] Figure 2 is an exploded view of apparatus shown in Figure 1.

[0014] Figure 3 is a perspective view of the apparatus as it would be viewed

with a human wrist clamped into the device.

[0015] Figure 4 is a side view of the clamping apparatus of Figure 3 with

portions of the wrist cut away to reveal the scaphoid and associated bone

structure of the wrist similarly to what would be shown with a lateral view X-

ray.

[0016] Figure 5 is a top view of the lower jaw plate of the clamping

apparatus.

[0017] Figure 5 A is a front view of the lower jaw plate of the clamping

apparatus. [0018] Figure 5B is a diagrammatic top view of the lower jaw plate with the

angles and sizes of the jig bores exaggerated to more clearly illustrate the

construction.

[0019] Figure 5C is an exaggerated diagrammatic side view of the lower jaw

plate of the clamping apparatus.

[0020] Figure 5D is a cross sectional view taken along lines 5D-5D of

Figure 5C

[0021] Figure 6 is a perspective view of a human hand and wrist showing

the approximate location on the palmar side of the hand where the guide wire

enters the tissue and the location of the incision that is made to permit the

drilling and placement of a fixation device.

[0022] Figure 7 is a posterior (dorsal) view of the human hand and wrist

with skin muscles and tendons broken away to reveal the bone structure as it

would appear in an anterior-posterior (AP) x-ray, illustrating a fractured

scaphoid and the necessary horizontal angular alignment of a pre-fixation guide

wire.

[0023] Figure 8 is a lateral view of the human hand and wrist with skin

muscles and tendons broken away to reveal the bone structure as it would

appear in a lateral x-ray, illustrating the fractured scaphoid and the necessary

vertical angular alignment of a pre-fixation guide wire. [0024] Figure 9 is a view similar to that of Figure 7, and illustrating a

portion of a cannulated drill bit being inserted over the guide wire that has

previously been inserted into the scaphoid bone.

[0025] Figure 10 is an enlarged detail of the tip end of the drill taken within

the circle in figure 9.

[0026] Figure 11 is a view similar to that of figure 9, showing the insertion

of a cannulated lag screw into the drilled hole in the scaphoid that was created

by the drill bit of figure 10.

[0027] Figure 12 is an enlarged view of the tip end of the cannulated lag

screw as it is passed over the guide wire.

[0028] Figure 13 is a view similar to that of Figure 11, but illustrating the

end result of the process, where the scaphoid bone fragments have been secured

in apposition by a lag screw type of final fixation device.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

[0029] The bone fracture fixation method and associated clamping and

guide wire alignment apparatus of the present invention are primarily directed

toward treatment of a fractured scaphoid bone in the human wrist. However,

the invention can be used in the treatment of fractures in other human or animal

bones that present the same challenge in determining and following the proper

course or angle for the implantation of a fixation device, such as a lag screw.

[0030] The vice and clamping apparatus of the present invention provides a

device to stabilize the limb having a broken bone while x-rays or MRI pictures are taken. Then, with the use of the x-rays or MRI, the vise provides alignment

means for the insertion of a guide wire that will thereafter pilot the course of

subsequent procedures, including drilling and the implantation of a fixation

device, such as a screw, across the fracture site of the bone.

[0031] Figures 1-4 illustrate a preferred form of the limb vise 2. Referring

to Figures 1 and 2, the vise comprises a pair of substantially parallel spaced

apart jaw forming plates 4 and 6. The jaws are moved and positioned with

respect to one another by three spacing posts 7, 8 and 9, one end of which are

each fixed to the sides of the bottom jaw 4. The other ends of the posts are

adjustably secured to the top jaw 6 by wing nuts 10 that thread onto bolt shafts

12 that protrude from the top jaw 6 into grooves 13, 14 and 15 in the spacing

posts.

[0032] Although threaded rods and nuts are shown in the preferred

embodiment of the invention, other forms of adjustable connectors can be used.

Such alternative structures might include a traditional vise screw, a ratchet

device, or electrical, pneumatic or hydraulically driven adjustable

interconnecting linkages. The jaws are said to be substantially parallel because

in use they appear to be parallel when casually viewed in their clamping

positions on the dorsal and palmar sides of a human wrist 13 (See Figures 3 and

4). However, the adjustment mechanism provided by the spacing posts 1, 8 and

9, or its equivalent, permit the plates to be placed in a slightly non-parallel

configuration if such a position is necessary to properly secure the particular patient's limb. The jaws 4 and 6 are shown as being substantially similar in

their lateral and longitudinal extents, however such resemblance is not

necessary. If the particular limb being clamped makes it necessary or desirable

for the two jaw plates to have different shapes, those diverse shapes would still

be within the scope of the invention. The jaw plates 4 and 6 are constructed

from any rigid material that is transparent, or pervious, to x-ray radiation, such

as any number of plastics.

[0033] The jaw plate 4 that is contacted by the palmar side of the patient's

wrist when it is in the clamping position will be referred to herein as the palmar

jaw. The opposing jaw 6 will be referred to as the dorsal jaw. The dorsal jaw 6

is fitted on its lower side with a semi-cylindrical pressure pad 11 that makes

contact with the dorsal side of the patient's wrist to force the volar (palmer)

side of the wrist down against the upper surface 5 of the palmer jaw when the

dorsal and palmar jaw plates are brought together. Positioning the volar side of

the wrist against, or at least in close proximity, to the surface 5 of the lower

clamping jaw is important for taking of proper x-rays of the wrist and for firmly

holding the wrist in a properly fixed position for the insertion of a guide wire.

Following the taking of x-rays or MRI pictures, the first step in the fixation of

the scaphoid bone is to drill a guide wire into the bone across the fracture site.

This guide wire acts as the pilot for future drilling and fixing operations. To

effectively use the guide wire in subsequent operations, it must be inserted at a

point on the wrist and at a compound angle that substantially corresponds to that of the axis of the scaphoid bone. The axis of the scaphoid bone represents

a compound angle comprising a horizontal component, as visualized in the A-P

x-ray view (Figure 7), and a vertical component, as visualized in the lateral x-

ray view (Figure 8). The horizontal component angle is generally in the range

of 25° to 35° from a vertical sagittal plane through the arm, while the vertical

component angle is generally in the range of 40° to 50° from the palmar plane.

[0034] Serving as a selection of alignment jigs, a plurality of bores or

conduits 28 are disposed in the palmar jaw 4 at a variety of compound angles,

one of which will substantially correspond to the compound angle of the axis of

the scaphoid bone of the patient. Each of the bores extends from the inferior

lower surface 3 of the palmar jaw 4 to the superior surface 5 of the palmar jaw.

The bores 28 diverge from a common opening 10L on the superior, or upper,

surface 5 of the palmar plate 4 to spaced apart openings, each of which intersect

the inferior surface 3 of the palmar jaw 4. Divergence of the bores from the

common opening 10L provides a number of jigs in the form of bores, or

conduits, each with a distinct compound angle. Surrounding the inside

circumference of the opening 10L is a metal collar 17 which serves as a marker

on the x-ray views to establish the position of the common opening for the

plurality of jigs. It is necessary that this position be ascertained to insure that

the wrist is properly positioned to receive the guide wire, as will be later

explained. [0035] It has been found that nine guide wire jig bores 28 provide a

satisfactory number from which to chose a single one that substantially matches

the compound angle of the axis of the scaphoid bone in the patient, however

this number of bores is not critical, as there can be more Or less. As shown in

Figures 1 to 5 and 5 A, 5B and 5C, the nine bores comprise three sets of three

bores each. The front set, seen in the top view, Figure 5A and the cross

sectional view of Figure 5C, comprises three bores 28a, 28b and 28c having

horizontal angular components H, measured from a sagittal plane 30 passing

through the common opening 10L, of, for example, 25°, 30° and 35°. The

middle set, 28a', 28b' and 28c' and the rear set, 28a" and 28b" and 28c" have

the same horizontal component angles.

[0036] The bores of the first set 28a, 28b and 28c are all inclined at an angle

to the palmar plane of, for example, 25°, as shown diagrammatically in Figure

5B. The three bores of the middle set, 28a', 28b' and 28c' are all inclined at a

vertical component angle to the palmar plane of, for example 45° while the rear

set, 28a", 28b" and 28c" are inclined at an exemplary component angle of

50°. These angles and the number of bores are exemplary only, it being

apparent that other selections of compound angles, numbers of or grouping of

bores are within the teaching of this invention. The respective angles of the

bores 28 may be whatever is required to substantially align the guide wire with

the pertinent axis of the scaphoid bone, considering the bone's inclination with

respect to a palmar plane, as seen in a lateral X-ray view of the wrist, and the horizontal angle of the bone with respect to the sagittal plane, as seen in the A-

P view of the wrist.

[0037] It is apparent that a single group of bores, such as the three sets of

three described above will function for only one wrist, that is, the left or the

right. The bores 28 for the left wrist have been discussed above. Accordingly,

a second group of bores.29 may be placed in the palmar jaw 4 for use with the

other wrist. The bores 29 are configured similarly to the left wrist bores 28,

except they are at reverse horizontal component angles, diverging from a

common opening 10R in the upper surface of the lower jaw 4 to a plurality of

spaced apart openings in the bottom surface of the lower jaw.

[0038] The novel percutaneous fixation method of the present invention

makes use of the clamping device 2 of the present invention. The purpose of

the fixation method and the accessory device 2 is to ultimately implant a

fixation device, such as a lag screw 44, accurately across the faces of the

fracture fragments so as to achieve maximum apposition of the bone fragments.

Snug fitting bone fragments tend to resist the entry of joint fluid into the

fracture site, thus eliminating the destruction of the blood clots that are

necessary to the union of the bone.

[0039] Because the scaphoid bone is relatively small and is disposed in the

wrist at a compound angle, it is normally very difficult to visualize the position

of the bone with sufficient accuracy that a fixation device may be properly

implanted across the fracture site. According to the present invention, and assuming a fracture through the scaphoid bone, a guide wire is drilled into the

bone along the same course as that desired for the intended fixation device,

such as, for example, a lag screw or a bone graft. Once the guide wire is

properly in place, the remaining steps of the fixation procedure may proceed,

using the guide wire as the pathfinder for subsequent steps of the procedure.

[0040] With the patient's wrist 13 secured in the clamping device 2, as

shown in Figures 3 and 4, anterior-posterior (AP) and lateral X-ray are taken to

demonstrate the position of the scaphoid bone in two planes. On the AP X-ray,

a line may be drawn, or a line may just be visualized, along the desired course

of the fixation device from the scaphoid distal pole through the bone fracture

site at the point where the fixation device should pass.

[0041] The lateral view X-ray is used to determine the vertical angle from

the horizontal of the scaphoid bone, as shown in Figure 4. When the vertical

angle is known, the course of the guide wire in the vertical plane is established.

Next, using the measured angle of bone inclination and the AP alignment of the

scaphoid bone a particular one of the applicable group of bores is selected for

piloting the guide wire into the scaphoid bone 16.

[0042] When the bore selection is made, a guide wire 32 is inserted into the

chosen bore hole. The wire is then drilled into the wrist tissue, the volar distal

pole 20 of the scaphoid bone and across the fracture faces 25 and 26 to the

dorsal proximal pole 21 of the scaphoid, as shown in Figures 10 and 11. Once

the guide wire 32 is implanted into the scaphoid 16, the guide wire is severed. between the wrist and the superior surface 5 of the palmar jaw, allowing the

vise 2 to be loosened and the wrist removed therefrom for completion of the

fixation procedure.

[0043] A small longitudinal incision 34 is made proximally and distally on

either side of the guide wire 32, as illustrated in Figure 7. Next, as shown in

Figures 10 and 11 a cannulated drill bit 40 is passed over the guide wire 32 and

through the incision 34 prepared in the tissue. Following the guide wire 32, the

drill bit 40 creates a pilot hole 36 in the scaphoid along the desired course of the

fixation device of sufficient diameter and length to accommodate such a device

44. The drill bit 40 is withdrawn and the cannulated lag screw 44 is passed

over the guide wire 32 and screwed into the scaphoid bone 16, as shown in

Figures 12, 13 and 14. When the screw has been fully seated and the bone

fragments are pulled together in apposition (Figure 14), the guide wire 32 is

removed and the small incision 34 is closed with a few sutures.

[0044] Employment of the apparatus 2 and the method of the present

invention result in good apposition of the bone fragments with reasonable

assurance that a union of the fragments will take place, since joint fluid has thus

been isolated from the fracture site.

Claims

I CLAIM:

1. A surgical tool for aligning fixation apparatus incident to the repair or

fusion of human limb bones, comprising, a vise, having relatively movable x-ray pervious first and second spaced

apart jaws for retaining a portion of a limb there between, means interconnecting the jaws and operable to fix the spacing there

between, at least one conduit extending through the second jaw and directed

toward the limb for receiving a guide wire.

2. The tool of claim 1 where the second jaw has upper and lower spaced

apart surfaces and where the at least one conduit is a plurality of conduits that

diverge from a common intersection with the said upper surface to spaced apart

intersections with the lower surface of the second jaw.

3. The appliance of claim 2 and further including an x-ray impervious ring

around the common opening on the upper surface of the second jaw.

4. A surgical appliance for repairing fractures of the scaphoid bone in a

human wrist, comprising, vise means, having upper and lower spaced apart jaws that are

transparent to x-ray radiation and are relatively movable toward and away from one another for retaining there between at least a portion of a human wrist, the

lower jaw having spaced apart inferior and superior surfaces, means interconnecting the upper and lower jaws for fixing the spacing

between the jaws, « a plurality of bores through the lower jaw that diverge from a common

intersection with the said superior surface to spaced apart intersections with the

inferior surface of the second jaw.

5. The appliance of claim 4 and further including a second plurality of

bores through the lower jaw that diverge from a common intersection "With the

said superior surface to spaced apart intersections with the inferior surface of

the second jaw.

6. An appliance for aligning a wire guide preparatory to insertion of a

fixation device for repairing limb bone fractures, comprising, first and second substantially parallel jaws for clamping there between a

limb containing a fractured bone, at least one adjustable connector for interconnecting and selectively

spacing the plates apart, one from the other, at least one straight wire guide passageway having a longitudinal axis

and carried by the second jaw, where the longitudinal axis of the passageway is aligned so that an extension thereof crosses the fracture site in the bone of the

limb being clamped between the jaws.

1. A method for percutaneously internally fixing a fractured limb bone

including, placing the limb in a stabilizing clamp, demonstrating the fractured bone to be fixed, resolving the course through the fractured bone of an intended fixation

device, placing a guide wire through exterior and interior tissue adjacent the

fractured bone along the resolved course and across the fracture faces of the

bone, incising the tissue around the guide wire; drilling a pilot hole in the bone through the fracture faces by directing a

cannulated drill over the guide wire; installing a cannulated fastening screw within the drilled hole and across

the bone fracture site to achieve apposition of the fracture fragments of the

bone.

8. The method of claim 7 where the step of demonstrating the fractured

bone to be fixed includes, demonstrating the anterior-posterior view of the fractured bone, and demonstrating the lateral view of the fractured bone.

9. The method of claim 8 and further including the step of extracting the

guide wire and closing the tissue incision.

10. A method for percutaneous fixing of a fracture of a human scaphoid

bone having volar and dorsal extents, including, placing the wrist in a stabilizing clamp, demonstrating the fractured scaphoid bone with anterior-posterior and

lateral X-rays, resolving the course through the scaphoid bone of a guide wire and the

intended fixation device, inserting a guide wire through a selected guide wire alignment device in

the stabilizing clamp that is substantially coincident with the resolved course

and into the scaphoid bone for a distance sufficient to cross the fracture site. drilling the scaphoid coaxially with the guide wire and through the

fracture faces therein; installing a cannulated fastening screw over the guide wire within the

drilled bone and across the fracture site to acquire apposition of the fracture

fragments of the bone.

11. The method of claim 10 and further including the step of extracting the

guide wire.

12. A method of installing a pre-fixation guide wire in <a fractured limb

bone, including, stabilizing the limb in a clamping vice, visualizing the required course of a pre-fixation guide wire that^' is to

span the fracture site in the limb bone, inserting a guide wire across the fracture site in the bone following

insertion of the guide wire into a conduit or bore in the clamping vice that

aligns the guide, wire with the visualized course.