US20200289183A1

US20200289183A1 - Driver for the insertion and removal of flexible fastening devices

Info

Publication number: US20200289183A1
Application number: US16/818,978
Authority: US
Inventors: William R. Krause; Daniel W. Christensen
Original assignee: Individual
Current assignee: FLEX TECHNOLOGY Inc
Priority date: 2019-03-13
Filing date: 2020-03-13
Publication date: 2020-09-17
Also published as: WO2020186239A1; US11253306B2; US20210282827A1; CA3094510A1

Abstract

A driver for inserting and removing flexible and non-flexible fastening devices. The driver has an attachment for interfacing with the proximal end of the device and a flexible driver rod for interfacing with the distal end of the device. Alternatively, the flexible driver rod can interface with both the distal and proximal ends of the fastening device. The driver further interfaces with a guide wire or other means that connect with the interior of the device.

Description

FIELD OF THE INVENTION

The present invention pertains to drivers for inserting and removing fastening devices and, more particularly, to a driver for inserting and removing flexible fastening devices.

BACKGROUND

The application of flexible fastening devices encompasses a broad spectrum of industries, included, but not limited to, manufacturing, construction, mining, transportation, agriculture, aviation, automotive, and medical. Flexible fastening devices, either tipped like screws and or flat end like bolts, have the characteristic of the cylindrical portion of the device being bendable about the longitudinal length. Flexible fastening devices are useable in many applications, from manufacturing to medical, to secure two curved, or misaligned, objects together.
In manufacturing and construction, fastening devices are used to join curved members together, to join misaligned holes, to absorb vibration between two components, and numerous other applications. Flexible devices are used to connect two or more members whereby a straight passage of the bolt or device is impossible due to a curved, crooked, or misaligned passage in one or both members. For example, two curved tubes can be connected by inserting a flexible bolt, or device, through the internal diameter of one to thread into the internal diameter of the other tube to join them together.
In the medical industry, flexible devices are particularly useful in the intramedullary fixation of fractured or severed bone fragments. Bone devices are typically used in internal fixation to anchor the fixation system to the relevant bone portions or to join two or more fragments of a fractured bone into close proximity for bone union. For example, devices can be used in plate or rod systems to treat complex fractures of long bones or conditions such as vertebral instability. In small bone fractures, such as the bones of the hands, feet, and wrist, the device is placed across the fracture site to bring the fracture surfaces in close proximity. In medium (clavicle, rib and others) and long (lower and upper extremities) bone fractures, devices can be inserted into the intramedullary canal for minimally invasive fracture reduction.
Various surgical procedures utilize devices to fixate anatomical tissue for healing. An example of a fixation device is a compression bone fixation device, commonly referred to throughout the present description as “compression device”, used to fixate two or more bone fragments or intramedullary fixation of a bone.
A surgical device driver is commonly used to insert bone devices; however, removal can be an issue, especially with flexible devices.

SUMMARY OF THE INVENTION

A driver for insertion and removal of a fastening device is disclosed. The fastening device has a distal end and a proximal end, each having a cross-section configuration. The driver comprises a flexible drive rod with a proximal end, a distal end and a cross-section configuration along its length. The flexible drive rod is selected from the group consisting of Nitinol, spring steel, flexible polymers and flexible composites to provide durability and flexibility. A coupling mechanism with its proximal end part of an extension rod and a distal end a rod receiving area. An extension drive rod connects the handle and the coupling mechanism. The handle can be at right angles to the extension rod or the two can be inline to one another. The flexible rod is configured to interact with at least one of the distal end and proximal end of the fastening device to enable insertion into or removal of the fastening device from an element.
When the fastening device is hollow, the flexible drive rod can extend from the proximal end to the distal end of the fastening device to apply simultaneous rotation to the proximal and distal ends of the fastening device to prevent the fastening device from twisting. The distal and proximal ends of the fastening device of the fastening device have a cross section larger than the cross section of the flexible rod to create a gap between the flexible rod and the distal and proximal ends for torque transmission.
In one embodiment the rod receiving area has a cross section complimentary to the flexible drive rod of the driver to prevent rotation of the rod within the receiving area. In another embodiment the rod receiving area is circular and the flexible drive rod prevented from rotation by locking screws. The extension rod is provided with a hollow channel extend completely or part way through to the outside of the handle and dimensioned to receive the flexible drive rod. Threaded locking screw receiving areas extend from the outer surface of the extension rod to the hollow channel and are dimensioned to receive the locking screws. The locking screws contact the flexible drive rod to prevent its rotation within the rod receiving are and hollow channel.
When the fastening device is flexible it enables the connection of two curved or nonlinear elements. An example of this would be a bone screw where two curved bones are connected.
A method of inserting and removing a flexible fastening device, with a proximal end, a distal end and a channel along its length, comprises the steps of:
a. selecting a flexible drive rod having a cross-sectional configuration complimentary to the periphery of the proximal end and distal ends of the flexible fastening device;
b. inserting said flexible drive rod into the rod receiving area of a coupling mechanism extending from an extension rod affixed to a handle;
c. inserting said flexible rod into a flexible fastening device and engaging the distal end and proximal end of the flexible rod;
d. turning the handle to rotate the flexible fastening device from both said distal end and said proximal end and preventing the flexible fastening device from twisting during insertion and removal.
The flexible drive rod can be prevented from rotating within the rod receiving area by selecting a rod receiving area having a complimentary cross section with the flexible rod. Alternatively, the flexible drive rod can be prevented from rotating within the rod receiving area by selecting a circular rod receiving area and securing the flexible drive rod with locking screws placed within the extension rod.
Preferably the flexible drive rod has a cross section less than the periphery of the distal and proximal ends of the fastening device, creating a gap for torque transmission.

BRIEF DESCRIPTION OF THE DRAWINGS

The objects, features, advantages and aspects of the present invention can be better understood with reference to the following detailed description of the preferred embodiments when read in conjunction with the appended drawing figures. All of the figures are drawn on an oversized scale, and like structure in different figures bears like reference numerals.

FIG. 1 is a perspective view of the flexible rod driver in accordance with the disclosed invention;

FIG. 2 is a perspective view of the flexible rod driver flexed, in accordance with the disclosed invention;

FIG. 3 is an isometric view of a flexible fastening device type applicable for industrial use having a driving head, a threaded flexible body, and a leading tapered segment in accordance with the invention;

FIG. 4 illustrates a detailed view of the head of the flexible fastening device of FIG. 3 in accordance with the invention;

FIG. 5 illustrates a cut away view illustrating the hollow core of the flexible fastening device of FIG. 3 in accordance with the invention;

FIG. 6 shows a flexible fastening device of the type applicable for medical use with the driver of FIG. 1 in accordance with the disclosed invention;

FIG. 7A is a perspective view of the proximal end of the flexible fastening device of FIG. 6 in accordance with the invention;

FIG. 7B is a detailed, perspective view of the area indicated as D in FIG. 7A in accordance with the invention;

FIG. 8A is a perspective view of the distal end of the flexible fastening device of FIG. 6 in accordance with the invention;

FIG. 8B is a detailed, perspective view of the area indicated as E in FIG. 8A in accordance with the invention;

FIG. 9A is a view of the proximal end of the flexible fastening device of FIG. 6 in accordance with the invention;

FIG. 9B is a view of the distal end of the flexible fastening device in FIG. 6 in accordance with the invention;

FIG. 10 is a perspective view of the assembled flexible rod driver with the insertion rod mounted and the flexible fastening device positioned over the insertion rod in accordance with the invention;

FIG. 11A is a side view of the assembled driver of FIG. 10 in accordance with the invention;

FIG. 11B is a sectional view A-A of the assembled driver of FIG. 10 in accordance with the invention;

FIG. 12A illustrates an end view of the Section B-B of FIG. 11B in accordance with the invention;

FIG. 12B shows the cross-sectional view of Section C-C of FIG. 11B in accordance with the invention;

FIG. 13A illustrates the Detail D as indicated in FIG. 12A and shows the gap between the insertion rod and the proximal end of the screw in accordance with the invention;

FIG. 13B illustrates the Detail E as indicated in FIG. 12B and shows the gap between the insertion rod and the distal end of the flexible fastening device 150 in accordance with the invention;

FIG. 14 is a perspective view of an alternate driver with movable threaded locking screws in a hollow extension rod configured to receive a guide wire in accordance with the invention;

FIG. 15 is a side view of the driver of FIG. 14 and indicating section A-A, in accordance with the invention;

FIG. 16A illustrates a bottom view of the driver of FIG. 15 and illustrates section A-A and the location of Detail B in accordance with the invention;

FIG. 16B is a cutaway bottom view of the Detail B in accordance with the invention;

FIG. 17 illustrates an exploded view of the assembly showing the driver, screw, and guide wire in accordance with the invention;

In FIG. 18 is a perspective view of the assembly of FIG. 17 with the flexible fastening device inserted over the guide wire and connected to the driver in accordance with the invention;

FIG. 19 is a bottom view of the driver having a hexagonal flexible fastening device coupling mechanism, the ends of which is identified as Detail F-F, in accordance with the invention;

FIG. 20A illustrates a bottom view of the driver showing the locking devices in the open position to permit movement of the guide wire as well as additional detail on Section F-F and the general location of Detail G in accordance with the invention;

FIG. 20B illustrates the area of Detail G from FIG. 20A in accordance with the invention;

FIG. 21A illustrates a bottom view of the driver showing the locking devices in the gripping position as well as the location of Section F-F and the general location of Detail G in accordance with the invention;

FIG. 21B illustrates the area of Detail G from FIG. 21A in accordance with the invention;

FIG. 22 illustrates the guide wire inserted into the interior of the fastening device in accordance with the invention;

FIG. 23 is a detailed perspective illustration of the interaction between the coupling mechanism and the flexible fastening device in accordance with the invention;

FIG. 24A is a perspective view of an alternate driver with a hollow extension cavity configured to receive a guide wire in accordance with the invention;

FIG. 24B illustrates the area of Detail B from FIG. 24A in accordance with the invention;

FIG. 25 illustrates a top view of the alternative driver showing location of Section A-A;

FIG. 26 illustrates the section A-A in FIG. 25 in accordance with the invention;

FIG. 27 is a perspective view of the alternative driver through which a guide rod has been inserted in accordance with the invention;

FIG. 28A illustrates a chart of flexible fastening device drive potential heads that can be incorporated into the drive head of the disclosed driver in accordance with the invention;

FIG. 28B illustrates a chart of internal flexible fastening device drives as listed by Wikipedia that can be incorporated into the drive head of the disclosed driver in accordance with the invention;

FIG. 29A is a top view of a flexible fastening device connecting two elements;

FIG. 29B is a side view of the elements of FIG. 29A;

FIG. 30 is a perspective view of the elements of FIG. 29A; and

FIG. 31 illustrated the flexible rod and coupling configured to receive a powered driver.

DETAILED DESCRIPTION OF THE INVENTION

Definitions

For the purposes herein the term “flexible fastening device” or “device” can be used interchangeably and shall refer to an externally threaded fastener having at least one threaded segment and at least one slotted, flexible segment that may be threaded or unthreaded.
For the purposes herein the term “screw” or “bolt” can be used interchangeably and shall refer to any externally threaded fastener having at least one threaded segment and at least one slotted, flexible segment that may be threaded or unthreaded.
For the purposes herein the term “flexible guide rod” and “flexible guide wire” can be used interchangeably and shall refer to a flexible rod or wire manufactured from a flexible, bio-compatible material.
The present invention addresses the insertion of a flexible fastening device into a curved channel or to secure two unaligned elements. The flexible driver can also be used to insert and remove flexible fastening devices that would twist when driven by only the proximal end through the engagement of both the proximal and distal ends of the fastening device. In addition, the disclosed provides a mechanism or tool to remove a proximal portion of a broken fastening device.
When the interior cavity of the distal end of a broken flexible fastening device has a shape complimentary to the disclosed flexible rod that can be inserted into the cavity from the proximal end, the device can be driven from the distal end. Since the cavity through which the rod must pass to enter the distal end of the broken device, the insertion rod is required to be flexible. The ideal choice of material for this application is Nitinol, a nickel-titanium alloy, although other metallic alloys, such as spring steel, or flexible polymers and composites that meet the criteria set forth herein are applicable. When inserted into the distal cavity, the complimentary rod can be used to rotate the device in a manner that it would back itself out.
In addition to flexibility, the material of manufacture must have the strength to be under high torque without snapping. This is especially applicable when used in industrial applications, and the selection of the appropriate material for the end use will be known to those skilled in the art based on the teachings herein.
Similarly, the drive rod can also be used to insert a flexible fastening device required to connect two elements having a non-linear connection channel, or cavity. Thus, when coupled with a driving attachment to the proximal end of the device, the driver is applying the driving torque to both the distal and proximal ends of the device thus relieving the twisting of the central flexible segment of the device. For exemplary purposes, the cross section of the drive rod and internal complimentary shaped internal cavity are shown as hexagonal, but any complimentary shapes that do not allow rotation relative to one another would be sufficient.
The disclosed driver has a flexible drive rod for rotating the flexible fastening device and advancing it along the longitudinal axis of the driver. The driver cooperatively engages with a drive recess, within the proximal end of the device, to achieve axial alignment of the device with the drive rod of the driver. When use in medical applications where a guide wire is required, the driver prevents rotation of the guide wire over which the device is placed.
Although a T-shaped handle is illustrated herein, the handle can be of any design convenient and that provides sufficient grip for the user. Alternatively, the extension rod and handle can be eliminated, such as illustrated in FIG. 31, and replaced with a powered driver as known in the art.
The T-handle driver 100, illustrated in FIG. 1, is used for the insertion and removal of flexible fastening devices, enabling the removal of flexible, as well as inflexible, fasteners, such screws and compatibly configured bolts. The driver 100 has a handle 110, an extension shaft 120, a coupling mechanism 130, and a flexible rod 140 with a tip 142. In the embodiment of FIG. 1, the flexible rod 140 is an integral part of the device; in later embodiments the rod is a separate element affixed to the handle. The coupling mechanism 130 has an external configuration to interact with the proximal end of the intended device and an internal receiving area 132 configured to receive the flexible rod 140. The coupling mechanism 130 can be used with or without the flexible rod 140. In situations where the flexible fastening device proximal connection point is readily available and the flexible rod of the device short, the flexible rod 140 may not be required. In this embodiment the flexible rod 140 is permanently secured within the internal receiving area 132 of the coupling mechanism 130. Embodiments disclosed herein after provide a removable flexible rod, or guide wire, that is removable from the handle.
In FIG. 2 the driver 100 is illustrated as it would appear when inserted into a flexed flexible fastening device. As noted above, the flexible rod 140 is manufactured from a flexible material such as Nitinol. As the flexible rod 140 is being inserted into a channel for insertion or removal of a flexible screw, it is preferable that the rod 140 be smooth along its length.
In most situations the flexible rod 140 is connected to the coupling mechanism 130 to penetrate the intended fastening device's internal opening to couple with at least the internal distal end of the intended flexible fastening device. This is illustrated and described in more detail hereinafter in conjunction with FIG. 10. Optimally the flexible rod 140 connects with both the distal end and proximal end of the flexible fastening device to facilitate insertion and/or removal without twisting the fastening device.
In the embodiment illustrated in FIGS. 3-5 the fastening device 205 has a conventional screw configuration with the leading end segment 210 having a tapered edge 222. The threads 224 run the length of the center segment 213 from the chambered leading end segment 210 to the driving head 212. A serpentine slot 228 (FIG. 3) runs in a helical fashion within the root diameter 225 of the threads 224 to provide flexibility.
FIG. 4 is a sectional view the fastening device 205 of FIG. 3 showing the serpentine, helical slot 228 within the root diameter 225 of the center segment 213 to provide the flexibility to the fastening device 205. In FIG. 5 a portion of the central cavity 216 extends from the leading tapered edge 222 to the driving head 212. The driving end 212 of the fastening device 205 is furnished with an example hexagonal cross section or similar receiving recess 227 to receive the coupling mechanism 130, or other rotational force device. The rod receiving notch 229 engages the flexible rod 140 in the rotation of the fastening device 205. To incorporate the hollow flexible segment 213 into the fastening device 200, the flexible segment 213, the leading tapered end 210, and driving head 212 all can be made separately in parts and joined together using traditional joining techniques such as precision welding.
FIG. 6 shows a fastening device for medical use, in this example a bone screw 150 such as disclosed in U.S. Pat. No. 10,136,930 B2, into which the driver rod 140 of the driver 100 is inserted in order to insert or remove the screw 150. The screw 150 is composed of three sections: an attachment end 154, a central section 152, and a leading end 156. The attachment end 154 of the screw 150 and at least the tip 142 of the driver rod 140 are configured to interact to facilitate insertion and removal of the screw 150. It is preferable that the length of the driver rod 140 have a cross-section configuration compatible with the of both the attachment end 154 and leading end 156 of this example, as well as any other fastening devices.
FIGS. 7A and 7B illustrate the screw 150 and the proximal end 154 illustrating the internal cavity 155 for receiving the coupling mechanism 130 of the driver 100. For the sake of clarity and convenience, the internal cavity 155 is depicted as a hexagonal shape to receive a hexagonally shaped driving coupling mechanism 130 on the driver 100. Other internal drive shapes are portrayed in FIG. 28B. Preferably the cavity 155 and coupling mechanism 130 are of the same shape and complimentary to ensure an adequate transmission of torque for screw 150 insertion or withdrawal.
FIGS. 8A and 8B illustrate the bone screw 150 and the distal end 156 with the interior cavity 157 for receiving the flexible rod 140 or the guide wire 190 (FIG. 17). Preferably the cavity 157 and flexible rod 140 are of the same shape and complimentary to ensure an adequate transmission of torque for screw 150 insertion or withdrawal.
FIG. 9B illustrates the proximal end 154 and FIG. 9A the distal end 156 of the screw 150 to show the internal channel 151 of the screw 150. Although it is preferable that the internal channel 151 have the same configuration at the proximal end 154 and distal end 156, these can differ as the proximal end 154 is engaged with the coupling mechanism 130 and the distal end 156 with the flexible rod 140.
FIG. 10 shows the driver 100 coupled to the screw 150 in preparation for insertion or after removal. As illustrated the flexible driver rod 140 is positioned within the coupling mechanism 130, either permanently or as a friction fit. The flexible driver rod 140 is inserted through the channel 151 of the screw 150 and the coupling mechanism 130 inserted in the internal cavity 155 of the proximal receiving end 154 of the screw 150. The distal end 142 of the flexible rod 140 is then inserted in the internal distal receiving end 156 of the screw 150. The coupling mechanism 130 is complimentary to the internal cavity 155 of the proximal receiving end 154 of the screw 150 such that when torque is applied to the handle 110 of the driver 100, the torque is transmitted to the screw 150. Likewise, the distal end 142 of the flexible drive rod 140 coupled to the driver 100 is complimentary to the internal distal receiving end 156 such that when the applied torque of the driver 100 is applied, the torque is simultaneously transmitted to the distal end 156 of the screw 150. Thus, the screw is driven at both the distal and proximal ends.
FIG. 11A shows the side view of the driver-assembly 175 which, for description purposes, consists of driver 100 inserted into the screw 150 as well as the location of section A-A. Customary break lines are use used to provide a more compact illustration. FIG. 11B shows the cut away view of Section A-A and identifies the locations of Sections B-B and C-C.
FIG. 12A shows an end view of the Section B-B (FIG. 11B) with the coupling mechanism 130 located inside the proximal end 154 of the device 150 and the location of Detail D of FIG. 13A. FIG. 12B shows the cross sectional view of Section C-C (FIG. 11B) with the flexible drive rod 140 inside the distal end 156 of the flexible fastening device 150 and the location of Detail E illustrated in FIG. 12B.
FIGS. 13A and 13B illustrate Detail D (FIG. 11A) and Detail E (FIG. 11B) to show the gap 176 between the coupling mechanism 130 and the proximal end of the device 154 and gap 178 located between the flexible drive rod 140 and the distal end 156 of the device 150. Having a small gap between the complimentary shape of the respective parts allows for torque transmission from the driver to the device in both the proximal and distal regions of the device. As will be obvious to those skilled in the art, the gap can vary depending upon the diameter of the flexible fastening device. In the example illustrated, a flexible rod for use in a bone screw having a 3-6 mm (0.118-0.236 in) diameter flexible driver rod has an optimal gap 176 of about 0.050-0.34 mm (0.002-0.014 inch). The smaller the screw, the smaller the maximum gap allowance will be as it is dependent upon the cross-sectional shape of the flexible driver rod 140 and the internal channel 151 as well as final manufactured tolerances.
In another embodiment shown in FIG. 14, the driver 180 has a handle 181, an extension rod 189 with movable threaded locking screws 182, 184 and a device coupling mechanism 186. As with the driver 100 a coupling mechanism 186 connects with the flexible fastening device to be removed or inserted, however in this embodiment, the coupling mechanism 186 is configured to receive a guide wire 190 (FIG. 17) which is held in position by threaded locking screws 182 and 184, permitting removability of the guide wire, or flexible guide rod, 190. Other mechanisms of holding the guide rod 190 within the driver can be substituted for the threaded locking screws as would be known in the art.
FIG. 15 is a side view of the driver 180 showing the location for Section A-A which is illustrated in more detail in FIG. 16A from a bottom view. Also illustrated in FIG. 16A is the location of Detail B which is illustrated in detail in FIG. 16B. The extension rod 189 of the driver 180 has a hollow opening 188, or channel, through the length of the extension rod 189 for the passage of a guide wire 190 that is inserted through the screw 150 for engagement with the screw's 150 distal end 156 during insertion or removal.
In this embodiment the interior receiving area 188 of the coupling mechanism 186 is circular rather than complimentary with the guide wire 190. To prevent rotation of the guide wire 190, the locking screws 182 and 184 are secured against the guide wire 190.
FIG. 17 illustrates the exploded assembly 200 consisting of the guidewire 190, screw 150 and driver 180. In this figure the screw 150 is attached to the driver 180 to be placed over the guide wire 190 after the wire has been inserted in a channel, such as a bone, as described herein.
Removal of the screw 150 would involve placing the guide wire 190 into the screw 150 and then connecting the proximal end of the screw 150 to the extension rod 189. Conversely, to insert the screw 150, or flexible fastening device, into the bone, or other channel, the guide wire 190 would be threaded through the reamed bone, or channel. The screw 150, with the driver 180 attached, would then be inserted along the guide wire 190 and secured by the flexible fastening device threads.
In FIG. 18 the assembly 200 has been configured for use with the screw 150 inserted over the guide wire 190 and connected to the driver 180.
FIG. 19 shows end view of assembly 200 and the location of Section F-F.
FIG. 20A shows Section F-F and the general location of Detail G. In FIG. 20B, illustrating Detail G, the screw 150 has been inserted over the guide wire 190 which is free to move and rotate for insertion and removal as the locking screws 182, 184 have been withdrawn, leaving gaps 182A and 184A.
In FIG. 21A the locking screws are illustrated in the gripping position to prevent rotation of the guidewire 190. FIG. 21B shows the Detail G with the locking screws 182, 184 screwed down and clamping the hexagonal guide wire 190 to prevent rotation. As the guide wire 190 needs to lock to enable rotation, the configuration of the guide wire 190 must be such that locking, using the flat surface of the locking screws 182 and 184, is possible. If, in some embodiments, it is preferable to use locking screws having different configuration, the guide wire will need to have a complimentary shape.
FIG. 22 shows the location for Detail E in FIG. 23 where detail of the coupling mechanism 186 engaged in the proximal end 154 of the screw 150 is illustrated.
In another embodiment illustrated in FIG. 24A, the driver 160 has a handle 161, an extension rod 169 and a coupling mechanism 163. Detail B is shown in FIG. 24B to illustrate a cavity 165 within the coupling mechanism 163 which has a shape complimentary to the guide rod 190 to prevent rotation about the guide wire 190. The guide rod 190 is maintained within the cavity 165 through a friction fit between the complimentary cross-section configurations.
It can be beneficial in some applications to have the configurations of the coupling mechanism, extension rod and/or flexible rod changed. In these embodiments, additional locking screws can be used within the extension rod to change out the coupling mechanism and/or flexible rod. In applications where the extension rod needs to be changed, the driver would need to be manufactured in two parts and the extension rod extended into, and secured, within the handle using methods known in the art.
FIG. 25 shows the side view of the driver 200 for the location of Section A-A.
FIG. 26 shows the sectional view A-A with the cavity 202 through the length of the driver 200
FIG. 27 shows the driver 200 over the guide wire 190 which can slide axially through the cavity 202 while allowing torque transmission by using complimentary cross section configurations between the cavity 202 and the guide wire 190.
FIGS. 28A and 28B illustrate examples of various attachment drive configurations possible for the flexible fastening device and drive shapes for a driver.
FIGS. 29A and 29B and FIG. 30 illustrate the disclosed fastening device used to secure two elements together. Figure A illustrates, from a top view, the empty channel 400 and the insertion of a fastening device 420. As seen in the side view of FIG. 29B and FIG. 30 the fastening device 420 extends through the channel 400 and into the adjoining element.

Claims

What is claimed is:

1. A driver for insertion and removal of a fastening device, said fastening device having a distal end, a length, and a proximal end, each of said distal end and proximal end having a cross-section configuration, said driver comprising:

a. a flexible drive rod, said flexible drive rod having a proximal end, a distal end, and a cross-section configuration along a length;

b. a coupling mechanism having a proximal end and a rod receiving area;

c. a handle; and

d. an extension rod, said extension rod connecting said handle and said coupling mechanism

wherein said cross-section configuration of said flexible drive rod is configured to interact with said cross-section configuration of said at least one of said distal end and said proximal end of said fastening device to enable said fastening device to be inserted into or removed from at least one element.

2. The driver of claim 1 wherein said fastening device is flexible to enable connection of two of said at least one element having non-linear connection channels.

3. The driver of claim 1 wherein said fastening device has a channel along its length for receiving said flexible drive rod, wherein said flexible drive rod extends from said proximal end to said distal end of said fastening device to apply simultaneous rotation to said proximal end and said distal end of said fastening device.

4. The driver of claim 1 wherein said flexible drive rod is dimensioned to be received within and extend through said proximal end of said fastening device.

5. The driver of claim 1 wherein said coupling mechanism rod receiving area has a cross section complementary to said proximal end of said fastening device.

6. The driver of claim 3 wherein said fastening device is a bone screw.

7. The driver of claim 3 wherein said distal end of said fastening device and said proximal end of said fastening device have a cross section larger than said cross section of said flexible drive rod to create a gap for torque transmission.

8. The driver of claim 1 wherein said rod receiving area is configured to compliment said flexible drive rod cross-section configuration to prevent rotation of said flexible rod.

9. The driver of claim 1 wherein said rod receiving area is circular.

10. The driver of claim 1 wherein said extension rod further comprises a hollow channel and threaded locking screw receiving areas extending from an outer surface of said extension rod to said hollow channel, said hollow channel dimensioned to receive said flexible drive rod and said locking screw receiving areas dimensioned to receive locking screws to secure said guide rod within rod receiving area and said extension rod.

11. The driver of claim 10 wherein said hollow channel extends through said handle to an outer surface of said handle.

12. The driver of claim 10 wherein said rod receiving area is circular and said locking screws prevent rotation of said flexible rod.

13. The driver of claim 1 wherein said flexible drive rod is selected from the group consisting of Nitinol, spring steel, flexible polymers and flexible composites.

14. The driver of claim 1 wherein said extension rod is connected to said handle at right angles.

15. A method of inserting and removing a flexible fastening device having a proximal end, a distal end and a channel along a length comprising the steps of:

a. selecting a flexible drive rod having a cross-sectional configuration complimentary to a periphery of said proximal end and a periphery of said distal end of said flexible fastening device;

b. inserting said flexible drive rod into rod receiving area of a coupling mechanism extending from an extension rod affixed to a handle;

c. inserting said flexible drive rod into said flexible fastening device and engaging said distal end and said proximal end of said flexible rod;

d. turning said handle to rotate said flexible fastening device from both said distal end and said proximal end;

wherein rotating said flexible fastening device from said distal end and said proximal end prevents said flexible fastening device from twisting during insertion and removal.

16. The method of claim 15 further comprising the step of preventing said flexible drive rod from rotating within said rod receiving area by selecting a rod receiving area having a complimentary cross section with said flexible drive rod.

17. The method of claim 15 further comprising the step of selecting a flexible drive rod having a cross section less than said periphery of said distal end of said fastening device and said periphery of said proximal end of said fastening device, creating a gap for torque transmission.

18. The method of claim 15 further comprising the step of preventing said flexible drive rod from rotating within said rod receiving area by selecting a circular rod receiving area and securing said flexible drive rod with locking screws placed within said extension rod.