WO2015050940A1

WO2015050940A1 - Torqueable control handle with locking mechanism

Info

Publication number: WO2015050940A1
Application number: PCT/US2014/058549
Authority: WO
Inventors: Gary L. Graham; Blake E. IMMERFALL; James Alan KALTHOFF; Mark A. Mcmahan; Scott P. YOUNGSTROM
Original assignee: Dgimed Ortho, Inc.
Priority date: 2013-10-01
Filing date: 2014-10-01
Publication date: 2015-04-09

Abstract

A torqueable control handle is provided. The torqueable control handle may be used with, for example, a surgical drilling assembly. The torqueable control handle includes an outer housing, an inner housing slidingly received within the outer housing; an elongate shaft coupled to the outer housing; a retractable guide tube assembly received within the elongate shaft; a flexible cable drilling assembly; and an actuation mechanism operably coupled to the outer and inner housings and engageable with a surgical instrument such as a surgical drilling assembly.

Description

TORQUEABLE CONTROL HANDLE WITH LOCKING MECHANISM

FIELD OF THE INVENTION

[0001] The invention relates to a torqueable control handle for use with a surgical instrument. More particularly the invention relates to a torqueable control handle for use with a surgical instrument that includes a mechanism for locking said surgical instrument to prevent it from advancing.

BACKGROUND OF THE INVENTION

[0002] A wide variety of surgical instruments require a control handle to actuate the instrument. Control handles are typically an integral part of the instrument itself and located proximal to the shaft of the instrument. The intermediate shaft operably couples the proximal control handle and the distal instrument. An actuation member is typically located on the control handle and allows the user to manipulate and actuate the surgical instrument.

[0003] On exemplary surgical instrument that may require a control handle is a surgical drilling device. For example, there are surgical procedures that often require the cutting or drilling of holes or channels into bone, teeth, or soft tissue, such as can be used for securing components made of metal or other materials to the bone of a patient.

[0004] A number of different surgical drilling devices are available for this purpose, many of which include a motor and a drill bit that can provide a hole of the desired depth and diameter. An example of such a device is described in U.S. Pat. No. 5,695,513 to Johnson et al. and International Publication No. W097/32577 to Johnson et al., the disclosures of which are incorporated by reference herein for all purposes. The Johnson et al. references describe a flexible cutting instrument that is formed through the use of a helically wound cable made of a metal such as Nitinol or another superelastic alloy. In this device, the cable is bent to a predetermined bend radius and rotated in a direction that tends to tighten the helically wound fibers of the cable. Drilling with this device is performed while continuously maintaining the cutting means at least partially within the hole being drilled and advancing the cable through its holder. Devices of this type can provide sufficient drilling capabilities for many situations; however, there is a continued need for additional surgical drilling tools and methods for certain surgical procedures and situations.

[0005] Another such device is described in U.S. Pat. No. 8,337,499 to Sasing et al. the entirety of which is hereby incorporated by reference. Sasing describes a surgical drilling device having a flexible cable drill and a retractable arcuate guide tube. However, the surgical drilling device of Sasing et al. device is difficult to manipulate, requires a plurality of push and pull cables that are prone to breaking and does not provide a fail-safe, locking mechanism for controlling the retractable arcuate guide tube and drill cable therewithin.

[0006] Another shortcoming in conventional devices is that the control handle and actuation member typically require both hands to manipulate them, which is disadvantageous for surgeons who need at least one hand free.

[0007] Therefore, there is a need for control handles that are easy for the surgeon to manipulate by requiring only one hand to operate it thus allowing the surgeon's second hand free for other surgical tasks. There is also a need for control handles that advantageously include an actuation mechanism that restrains of "locks" the surgical instrument from advancing to reduce the chances of the surgical instrument, for example a drill cable, from exiting the device at an incorrect angle.

BRIEF SUMMARY OF THE INVENTION

[0008] The foregoing needs are addressed by the torqueable control handle in accordance with the invention.

[0009] In one aspect of the invention, a surgical drilling device having a flexible cable drill and a retractable arcuate guide tube with a torqueable control handle is provided. A retractable arcuate guide tube for a flexible cable drill allows the use of a large bend radius for the cable drill and allows the cable drill to be deployed inside the limited space of the inner cavity of an intramedullary nail during a surgical procedure. A large bend radius for the cable drill helps to maximize the lifetime of the cable drill. [0010] Surgical drilling in accordance with the present invention utilizes a flexible cable drill cable that is advanced axially through a retractable arcuate guide tube during the drilling process.

[0011] In one exemplary embodiment of the present invention, the cable drill is preferably advanced at a rate wherein the cable drill spends less revolutions in the arcuate guide tube than the life of the cable drill for a particular bend radius (as measured in number of revolutions).

[0012] In one aspect of the invention, a torqueable control handle is provided. The torqueable control handle may be used with, for example, a surgical drilling assembly. The torqueable control handle comprises an outer housing, an inner housing slidingly received within the outer housing; an elongate shaft coupled to the outer housing; a retractable guide tube assembly received within the elongate shaft; a flexible cable drilling assembly; and an actuation mechanism operably coupled to the outer and inner housings and engageable with a surgical instrument such as a surgical drilling assembly.

[0013] The retractable guide tube assembly may comprise an arcuate guide tube comprising a shape-memory material slidingly positioned within an elongate shaft. The arcuate guide tube may be entirely comprised of a shape-memory material or may include a first portion comprising a shape-memory material and a second portion comprising a second biocompatible material, such as stainless steel. The arcuate guide tube assembly is operatively coupled to the inner housing, which controllably advances and retracts the arcuate guide tube upon actuation of an actuation mechanism. A surgical instrument, such as a surgical drilling assembly, includes a first portion slidingly positioned in the arcuate guide tube assembly and a second portion slidingly engageable with an actuation mechanism in the torqueable control handle. In other aspects of the invention, the retractable guide tube assembly may include a guide tube that comprises a single linear portion.

[0014] In another aspect of the present invention, the torqueable control handle comprises an outer housing, an inner housing and an elongate shaft coupled to the housing. The elongate shaft defines a first arcuate portion and a second linear portion in a lumen therewithin. A retractable guide tube assembly defining a channel therewithin includes a first deployable hook portion and a second linear rod operatively coupled thereto. The retractable guide tube assembly is concentrically received within the lumen of the elongate shaft. The first deployable hook portion is positioned within the first arcuate portion of the elongate shaft and the linear rod is positioned within the second linear portion of the elongate shaft. The linear rod is fixedly coupled at its proximal end to the distal end inner housing. A actuation mechanism is pivotably received within outer and inner housings and its operation advances inner housing in the distal direction to an actuated position, which in turn deploys the retractable guide tube assembly. A flexible cable drill is received within a slot in the actuation mechanism and is operably and concentrically received within the guide tube assembly channel. The flexible cable drill includes a first drilling portion slidingly and retractably positioned in the arcuate guide tube channel and a second linear actuating portion slidingly positioned within the linear rod channel.

[0015] In another aspect of the invention, the elongate shaft is operably coupled to the outer housing and defines a linear lumen therewithin. The retractable guide tube assembly includes a deployable hook portion and a linear rod operatively coupled thereto. The deployable hook portion is made of a shape-memory material, such as Nitinol, and has a first expanded or "remembered" shape and a second retained or linear shape. The deployable hook assumes a second shape when retracted into the linear lumen. Upon deployment from the linear lumen, the hook assumes its expanded or remembered shape eliminating the need for a first arcuate portion within the elongate shaft.

[0016] In other aspects of the invention the elongate shaft may include an exit aperture proximate a distal end thereof. Depending on the surgical instrument being used with the torqueable control handle in accordance with the invention, the exit aperture may be at the distal end of the elongate shaft or may be circumferentially positioned on the elongate shaft proximate the distal end.

[0017] In other aspects of the invention, a torqueable control handle is described in the numbered clauses that follow: 1. A torqueable control handle for a surgical instrument comprising:

an outer housing;

an inner housing slidably engageable with said outer housing, said inner housing including first and second inner housing cam surfaces;

an elongate shaft including distal and proximal ends, said elongate shaft operably coupled to said outer housing at the proximal end, said elongate shaft having a lumen therewithin and an exit aperture proximate said distal end;

an actuation mechanism operably received within said inner housing and actuatable between an actuated position and a non-actuated position, said actuation mechanism including first and second actuation mechanism cam surfaces in mating engagement with said first and second inner housing cam surfaces;

a retractable guide tube assembly received within said elongate shaft lumen; said retractable guide tube assembly including a distal end and a proximal end, said proximal end operably coupled to said inner housing;

wherein the distal end of said retractable guide tube assembly is structured to slidably exit said exit aperture when said actuation mechanism is in the actuated position and further wherein said retractable guide tube assembly is structured to slidably retract into said elongate shaft lumen when said actuation mechanism is in the non-actuated position.

2. The torqueable control handle of clause 1 wherein said actuation mechanism is pivotably engageable with said outer housing.

3. The torqueable control handle of clause 1 wherein said elongate shaft defines a first arcuate portion and a second linear portion.

4. The torqueable control handle of clause 1 wherein said elongate shaft defines a single linear portion.

5. The torqueable control handle of clause 1 wherein said exit aperture is circumferentially positioned on said elongate shaft.

6. The torqueable control handle of clause 5 wherein the distal end of said retractable guide tube assembly includes a hook portion that has a first expanded shape and a second retained shape.

7. The torqueable control handle of clause 6 wherein said hook portion is structured to exit said exit aperture and assume the first expanded shape when said actuation mechanism is in said actuated position. 8. The torqueable control handle of clause 1 wherein said exit aperture is at the distal end of said elongate shaft.

9. The torqueable control handle of clause 8 wherein the distal end of said retractable guide tube assembly includes a linear portion structured to exit said exit aperture when said actuation mechanism is in the actuated position.

10. The torqueable control handle of clause 1 further including a surgical instrument concentrically receivable within said inner housing and said retractable guide assembly, said surgical instrument engageable with said actuation mechanism.

1 1. The torqueable control handle of clause 10 wherein said actuation mechanism is structured to lock said surgical instrument when said actuation mechanism is in said non-actuated position. While multiple embodiments, objects, features and advantages are disclosed, still other embodiments of the invention will become apparent to those of ordinary skill in the art from the following detailed description taken together with the accompanying figures, the foregoing being illustrative and not restrictive.

BRIEF DESCRIPTION OF THE DRAWINGS

[0018] For a better understanding of the invention, and to show how the same may be carried into effect, reference will now be made, by way of example, to the accompanying drawings, in which:

[0019] FIG. 1 is a perspective view of the torqueable control handle in accordance with the invention for use with a surgical drilling device.

[0020] FIG. 2 is a side cut away view of the torqueable control handle in accordance with the invention shown with a surgical drilling device.

[0021] FIG. 3 is a top plan view of the torqueable control handle in accordance with the invention with an actuation mechanism shown in the actuated position.

[0022] FIG. 4 is a side view of the torqueable control handle in accordance with the invention with the actuation mechanism shown in the actuated position and showing the retractable arcuate channel in the deployed or actuated position. [0023] FIG. 5 is a perspective view of the actuation mechanism in accordance with the invention.

[0024] FIG. 6 is a perspective view of the inner housing showing detail of the drill cable channel in accordance with the invention.

[0025] FIG. 7 is a perspective view of various aspects of the inner and outer housings of the control handle in accordance with the invention.

DETAILED DESCRIPTION OF THE INVENTION

[0026] The torqueable control handle with locking actuation mechanism in accordance with the invention is suitable for use with a variety of surgical instruments. However, for ease of explanation the present invention will be described as used with a surgical drilling device for use with intramedullary rods.

[0027] Intramedullary rods are commonly used in orthopedic surgery for breaks in the long bones of the extremities, such as the tibia and femur. These rods are used to align and stabilize fractures or breaks of bones and to maintain the bone fragments in their proper alignment relative to each other during the healing process. In addition, intramedullary rods can provide strength to the bone during the convalescence of the patient. One common surgical rod implantation procedure involves drilling the bone marrow canal of the fractured bone from a proximal to a distal end of the bone and inserting an intramedullary rod into this evacuated space. In order to maintain the intramedullary rod in the proper relationship relative to the bone fragments, it is often desirable to insert bone screws or other fasteners through the distal and proximal portions of the intramedullary rod and one or both fragments of the bone. Such a fixation of the rod can make the construct more stable, prevent rotation of the rod within the bone, and prevent longitudinal movement of the bone relative to the intramedullary rod.

[0028] In order to fix the rod to the bone, intramedullary rods are commonly provided with at least one and frequently several apertures through each of the proximal and distal ends. The apertures are configured for receiving screws or fasteners of various types. To insert such screws, the objective is to drill holes through the tissue and bone in proper alignment with the holes in the intramedullary rod, and to insert the screws through the holes to lock the intramedullary rod in place.

[0029] The procedure entails selecting the proper length of an intramedullary rod or nail to repair a broken bone. A jig or nail insertion handle is coupled to the proximal end of the intramedullary rod and locked into place. An appropriate sized adaptor is coupled to the jig insertion handle with bolt means. The adaptor is sized for the particular nail being used and includes a variety of indexing slots thereon that correspond to the location of the proximal and distal apertures in the nail. A drill can then be passed through the bone and the drill cable tunneled through the bone at the proper distance to locate the distal and proximal holes.

[0030] The present invention may also be used with an indexing adaptor as described in U.S. Prov. Appln. Ser. No. 61/862,761, incorporated herein in its entirety, which solves the problem of eliminating the numerous adaptors that are required for the surgical repair of long bones.

[0031] Referring now to FIG. 1, the torqueable control handle with locking actuation mechanism in accordance with the invention broadly includes outer housing 12, inner housing 14, actuation mechanism 16, elongate shaft 18 and arcuate guide tube assembly 20. The torqueable control handle in accordance with the invention optionally includes extension tube 22 and drill cable or wire 24 when the control handle 10 is used in conjunction with a surgical drilling device. Elongate shaft 18 defines a lumen (not shown) therewithin and is operatively coupled at its proximal end 26 to the distal end 28 of outer housing 12 and at its proximal end 27 to shaft tip 34. Shaft tip 34 includes an aperture 100 therein to accommodate the exit of arcuate portion 30 from the lumen of elongate shaft 18 in operation. [0032] Arcuate guide tube assembly 20 includes a first arcuate portion 30 operatively coupled to a second linear portion 32. The distal tip 31 of first arcuate portion 30 may advantageously include a beveled tip to facilitate the exit of retractable guide tube assembly 20. In some embodiments, such as inside out drilling, retractable guide tube assembly 20 must be fully retracted to avoid interference with the inside of, for example, an intramedullary nail. If the distal tip 31 of the first arcuate portion 30 is constructed as a bevel, it minimizes how far retractable guide tube assembly 20 needs to be retracted inside housing 12 to avoid interference with the inside of the nail. Those of skill in the art will appreciate that depending on the surgical procedure and instrumentation being used, the distal tip of arcuate guide tube assembly 20 may be entirely circumferential.

[0033] A drive mechanism (not shown) may be operably coupled to drilling mechanism 21. Drilling mechanism including extension tube 22 and wire 24 Those of skill in the art will appreciate that wire 24 may be a wire, cable, filament, rod or the like and may be flexible or semi-flexible so long as it can slidingly and/or rotatably advance through elongate shaft 18 and retractable guide tube assembly 20 in the retractable guide tube's extended configuration. Drilling mechanism 21 is slidingly and rotatably received within retractable guide tube assembly 20 and elongate shaft 18. Optionally, the lumen wall of elongate shaft 18 and retractable guide tube assembly 20 may include a lubricious coating thereon to facilitate the slidability and/or rotatability of drilling mechanism 21. Drilling mechanism 21 is operably coupled to a drive mechanism (not shown), which is structured to axially and/or rotatably advance the drilling mechanism 21 through bone and soft issue of a patient. Drive mechanism 20 may comprise a manually driven actuating plunger or pusher element that can be axially or rotatably advanced to through elongate shaft 18 and retractable guide tube assembly 20 or may be an automated system comprising drill means known to those of skill in the art and as disclosed in U.S. 8,337,499 to Sasing et al.

[0034] Referring now to FIGS. 1-7 inner housing 14 is concentrically and slidably received within outer housing 12. Inner housing 14 includes a guide rail 40 that is mattingly and slidably received by guide rail groove 42 in outer housing 12. Inner housing 14 includes a drill cable channel 44 extending along a longitudinal axis thereof. Drill cable channel 44 operably receives drilling mechanism 21.

[0035] Outer housing 12 and inner housing 14 include mating outer housing slot 46 and inner housing slot 48, respectively, that operably and pivotably receive actuation mechanism 16. Outer housing includes first and second receiving openings 67, 68 that receive first and second side engagement knobs 58, 59 of actuation mechanism 16. Correspondingly, inner housing slot 48 includes a pair of elongate bottom openings 49 on either side that allows first and second side engagement knobs 58, 59 to move distally and proximally as actuation mechanism moves to and from the actuated and non-actuated positions.

[0036] Actuation mechanism 16 includes fmger-moveable lever 50, base 52, first and second protrusions 54, 56 and first and second side engagement knobs 58, 59. First and second side engagement knobs 58, 59 mate with first and second receiving openings 67, 68 in outer housing 12 which allows actuation mechanism to pivot between an actuated and non-actuated position during operation. First and second side engagement knobs 58, 59 are also received within engagement opening Pivot base 52 includes a pivot base aperture (not shown) therewithin for receiving drilling assembly 21. Pivot base 52 includes first and second cam surfaces 60, 62 that meet at point 64. Actuation mechanism also includes first and second slots 64, 66 that accommodate extension tube 22 of drilling assembly 21 when actuation mechanism 16 pivots between the actuated and non-actuated positions.

[0037] In operation, a user places extension tube 21 of drilling assembly through channel 44 of inner housing 14, and channels 64, 66 of actuation mechanism 16, through the second linear portion 32 of arcuate guide tube assembly 20 and the first arcuate portion 30 while the first arcuate portion is in the retracted or non- actuated position. Lever 50 is in the non-actuated position. The user actuates the device by moving lever 50 distally toward the actuated position. First cam surface 62 exerts force on a mating surface of inner housing 14 causing inner housing 14 to move distally. As inner housing 14 moves distally first arcuate portion 30 exits elongate shaft 18. The user then engages the drilling assembly 21 with a drive mechanism which rotates cable wire 24 to drill through bone and tissue. After completion of the procedure (or during a pause in the surgical procedure) the user may retract the cable drill assembly 21 inwardly into linear portion 32, channels 64, 66 and 44 manually or with external drive mechanism. Loving lever 50 proximally will pull 32 and 30 back to retract 30. Drill cable assembly 21 is not moved by actuator mechanism, but rather, slides freely except in the non-actuated position when it is "pinched" as described hereinbelow. Second cam surface 60 exerts a force on a second mating surface of inner housing 14 causing inner housing 14 to move proximally and retracting first arcuate portion 30 into elongate shaft 18. In the non-actuated position, channel 64 engages or "pinches" and "locks" the drill assembly 21 advantageously preventing it from exiting the arcuate portion 30 and aperture 100 of elongate shaft 18. Protrusion 54 snaps the actuating mechanism in the actuated and non-actuated positions. There is a small bump on the inside of channel 64 that exerts force or impinges on drill assembly 21 from the top surface when in the non-actuated position. Those of skill in the art will appreciate that given sufficient applied force the drill assembly may be advanced. However, the "locking" of the drill assembly referred to herein is a restraining of the drill assembly such that if a user advances the drill assembly when the retractable guide tube assembly is in the retracted position, wire 24 would not exit a intramedullary nail at a 90 degree position, but rather closer to 45 degrees. Thus, the wire 24 may drill into the knee in an exemplary femoral nail procedure and may drill into the ankle in an exemplary tibia procedure.

[0038] Those of skill in the art will appreciate that the torqueable control handle 10 in accordance with the invention may be used with the clip-on indexing adaptor disclosed in U.S. Prov. Appln. Ser. No. 61/862,761, the entirety of which is incorporated herein by reference.

[0039] Although the present invention has been described with reference to preferred embodiments, workers skilled in the art will recognize that changes may be made in form and detail without departing from the spirit and scope of the invention.

Claims

What is claimed is:

1. A torqueable control handle for a surgical instrument comprising:

an outer housing;

2. The torqueable control handle of claim 1 wherein said actuation mechanism is pivotably engageable with said outer housing.

3. The torqueable control handle of claim 1 wherein said elongate shaft defines a first arcuate portion and a second linear portion.

4. The torqueable control handle of claim 1 wherein said elongate shaft defines a single linear portion.

5. The torqueable control handle of claim 1 wherein said exit aperture is circumferentially positioned on said elongate shaft.

6. The torqueable control handle of claim 5 wherein the distal end of said retractable guide tube assembly includes a hook portion that has a first expanded shape and a second retained shape.

7. The torqueable control handle of claim 6 wherein said hook portion is structured to exit said exit aperture and assume the first expanded shape when said actuation mechanism is in said actuated position.

8. The torqueable control handle of claim 1 wherein said exit aperture is at the distal end of said elongate shaft.

9. The torqueable control handle of claim 8 wherein the distal end of said retractable guide tube assembly includes a linear portion structured to exit said exit aperture when said actuation mechanism is in the actuated position.

10. The torqueable control handle of claim 1 further including a surgical instrument concentrically receivable within said inner housing and said retractable guide assembly, said surgical instrument engageable with said actuation mechanism.

1 1. The torqueable control handle of claim 10 wherein said actuation mechanism is structured to lock said surgical instrument when said actuation mechanism is in said non-actuated position.