SURGICAL SYSTEM, DEVICE, AND METHOD FOR IMPLANTING A SURGICAL DEVICE WTIHOUT THE USE OF A GUIDE WIRE

Abstract

The present invention relates to a system, method, device and kit which utilize a modular pedicle screw implant that does not require the use of a guide wire for implantation and can be assembled in situ. The system, method, device, and kit include a surgical instrument for implanting a modular pedicle screw comprising a cannula coaxially aligned with a modified trocar style instrument or surgical shaft. The surgical shaft contains a first member of a surgical shaft-inner pedicle bone screw member joint, illustrated herein as a locking taper, for securing an inner member of a pedicle screw thereto. The inner member of a pedicle screw is further adapted to couple to an outer pedicle sheath. In combination, the inner member of a pedicle screw and the outer pedicle sheath form a solid modular pedicle screw.

Claims

1-18. (canceled)

19. A surgical system for implanting a modular pedicle screw, comprising: a cannula having a first proximal end portion and a second opposing distal end portion; a surgical shaft having a first end portion and a second end portion, the surgical shaft including a modular bone screw implant frangibly coupled to the second end portion, the surgical shaft dimensioned to be received within the cannula thereby forming a coaxial relationship with the cannula; and an outer sheath including a proximal most end and a distal most end, the outer sheath defining a hollow interior extending between the proximal most end and the distal most end, the outer sheath positionable about the surgical shaft, wherein the outer sheath is securable to the modular bone screw implant such that an entire length of the hollow interior of the outer sheath is occupied by the modular bone screw implant, thereby forming a solid pedicle screw.

20. The surgical system according to claim 19, wherein the modular bone screw implant includes threads on an outer surface thereof and the outer sheath includes threads on an inner surface thereof that are complimentary to the threads of the modular bone screw implant.

21. The surgical system according to claim 19, wherein the cannula includes a handle secured to the first proximal end portion thereof.

22. The surgical system according to claim 21, wherein the handle includes an opening dimensioned to receive the surgical shaft therethrough.

23. The surgical system according to claim 22, further including a cap securable to the first end portion of the surgical shaft, the cap configured to remove the surgical shaft from the cannula through the opening of the handle.

24. The surgical system according to claim 19, wherein the modular bone screw implant includes a pointed distal end portion.

25. The surgical system according to claim 19, wherein the second end portion of the surgical shaft includes a mating feature and a proximal end portion of the modular bone screw implant includes a locking feature, the mating feature of the surgical shaft configured to engage the locking feature of the modular bone screw implant to couple the surgical shaft to the modular bone screw implant.

26. The surgical system according to claim 25, wherein the mating feature of the surgical shaft is a taper and the locking feature of the modular bone screw implant is a tapered socket.

27. The surgical system according to claim 21, wherein at least one of the outer cannula and the handle is formed from a material selected from the group consisting of: stainless steel, platinum, and polyetheretherketone.

28. A surgical instrument, comprising: a surgical shaft having a first end portion and a second end portion, the surgical shaft including an inner pedicle screw portion frangibly coupled to the second end portion thereof; and an outer pedicle screw portion including a proximal most end and a distal most end, the outer pedicle screw portion defining a hollow interior extending between the proximal most end and the distal most end, the outer pedicle screw portion positionable about the surgical shaft, wherein the outer pedicle screw portion is securable to the inner pedicle screw portion such that the inner pedicle screw portion and the outer pedicle screw portion are coterminous, thereby defining a modular pedicle screw that is solid along an entire length thereof.

29. The surgical instrument according to claim 28, wherein the inner pedicle screw portion includes threads on an outer surface thereof and the outer pedicle screw portion includes threads on an inner surface thereof that are complimentary to the threads of the inner pedicle screw portion.

30. The surgical instrument according to claim 28, wherein the inner pedicle screw portion includes a pointed distal end portion.

31. The surgical instrument according to claim 28, wherein the second end portion of the surgical shaft includes a mating feature and a proximal end portion of the inner pedicle screw portion includes a locking feature, the mating feature of the surgical shaft configured to engage the locking feature of the inner pedicle screw portion to couple the surgical shaft to the modular bone screw implant.

32. The surgical instrument according to claim 31, wherein the mating feature of the surgical shaft is a taper and the locking feature of the inner pedicle screw portion is a tapered socket.

33. The surgical instrument according to claim 32, wherein the taper defines at least a partial conical configuration.

34. The surgical instrument according to claim 28, further comprising a cannula having a first proximal end portion and a second opposing distal end portion, the cannula dimensioned to receive the surgical shaft therein thereby forming a coaxial relationship with the surgical shaft.

35. The surgical instrument according to claim 34, wherein the cannula includes a handle secured to the first proximal end portion thereof.

36. The surgical instrument according to claim 35, wherein the handle includes an opening dimensioned to receive the surgical shaft therethrough.

37. The surgical instrument according to claim 36, further comprising a cap securable to the first end portion of the surgical shaft, the cap configured to remove the surgical shaft from the cannula through the opening of the handle.

38. The surgical instrument according to claim 35, wherein at least one of the cannula and the handle is formed from a material selected from the group consisting of: stainless steel, platinum, and polyetheretherketone.

Description

BRIEF DESCRIPTION OF THE FIGURES

[0022] FIG. 1 is a perspective view of a surgical instrument for implanting a modular pedicle screw in accordance with the present invention illustrating a surgical shaft inserted within a cannula;

[0023] FIG. 2 is a perspective view of the surgical shaft in accordance with the present invention;

[0024] FIG. 3 is a partial view of the surgical shaft in accordance with the present invention;

[0025] FIG. 4 is a perspective view of the inner member of the modular pedicle bone screw;

[0026] FIG. 5A is a perspective view of the outer sheath of the modular pedicle bone screw;

[0027] FIG. 5B is a perspective view of the modular pedicle bone screw;

[0028] FIG. 6 is a cross sectional view of the main body of the outer sheath of the modular pedicle bone screw;

[0029] FIG. 7 illustrates the insertion of the surgical instrument for implanting a modular pedicle screw into the pedicle of the vertebra;

[0030] FIG. 8 illustrates the removal of the cannula, exposing the surgical shaft;

[0031] FIG. 9 illustrates the insertion of the bone screw shaft, using the surgical shaft as a guide;

[0032] FIG. 10 illustrates the formation of the modular pedicle screw and removal of the surgical shaft from the patient;

[0033] FIG. 11 is an illustrative embodiment of a kit in accordance with the present invention;

[0034] FIG. 12 is an alternative embodiment of a kit in accordance with the present invention;

[0035] FIG. 13 is an alternative embodiment of a kit in accordance with the present invention.

DETAILED DESCRIPTION OF THE INVENTION

[0036] While the present invention is susceptible of embodiment in various forms, there is shown in the drawings and will hereinafter be described a presently preferred, albeit not limiting, embodiment with the understanding that the present disclosure is to be considered an exemplification of the present invention and is not intended to limit the invention to the specific embodiments illustrated.

[0037] Referring to FIGS. 1-6, a surgical instrument for implanting a modular pedicle screw, referred to generally as 10, is illustrated. The surgical instrument for implanting a modular pedicle screw 10 is preferably modeled after a standard Jamshidi style needle. Accordingly, the surgical instrument for implanting a modular pedicle screw 10 contains a first outer member, illustrated herein as a cannula 12 and a second inner member, illustrated herein as a modified trocar style surgical instrument shaft, referred to generally as trocar or surgical shaft 14. The cannula 12 contains a proximal end 16, a distal end 18, and an elongated main body 20. The elongated main body 20 is preferably rod shaped, having a generally hollow interior sized and shaped to receive the trocar or surgical shaft 14. In this orientation, the cannula 12 is co-axially aligned with the surgical shaft 14 to allow for the surgical shaft 14 to slide within the hollow interior.

[0038] A handle 24 attaches to the proximal end 16 via any means known to one of skill in the art, such as, but not limited to, threading or chemical fastening. The handle 24 may be ergonomically designed to provide a gripping means for the user. To allow for the surgical shaft 14 to be inserted into and removed or separated from the cannula 12, the handle 24 contains an opening 26 and a corresponding lumen (not illustrated). A detachable cap 28 allows the surgical shaft 14 to be easy removed from the cannula 12. The cannula 12 and the handle 24 may be made of any suitable materials for use in surgical procedures, including but not limited to stainless steel, platinum, or plastics such as thermoplastics such as polyether ether ketone (PEEK), or combinations thereof.

[0039] Referring to FIG. 2, an illustrative example of the modified surgical shaft 14 is shown. The surgical shaft 14 contains a first proximal end 30, an opposing second distal end 32, and an elongated main body 34. The elongated main body 34 is preferably rod shaped and solid, and sized to fit and slide within the hollow interior of the cannula 12. The distal end 32 of the surgical shaft 14 secures to an inner member of a modular pedicle bone screw 36A. The inner member of a modular pedicle bone screw 36A is designed to secure to an outer bone screw sheath 36B to form the modular pedicle bone screw, referred to in combination as 36, see FIG. 5B. As illustrated, the inner member of a modular pedicle bone screw 36A is a solid elongated body, preferably cylindrical shape, with a sharp or pointed end.

[0040] As shown on FIG. 3, the distal end 32 of the surgical shaft 14 contains a first member of a surgical shaft-inner pedicle bone screw member joint, illustrated herein as a locking taper 38 having tapered surfaces 40. Preferably, the first member of a surgical shaft-inner pedicle bone screw member joint is frangibly attached to the distal end 32 of the modified surgical shaft 14. The locking taper is designed to provide accurate alignment with and mate to a corresponding surface so that when mated, frictional forces are sufficient to prevent rotation with respect to one another and require considerable force to separate. The locking taper 38 may include, but is not limited to a Morse locking taper or a Jarno locking taper, and may be designed to have a partial cone configuration or have a general cone shape having various angles of tapering. The locking taper 38 is inserted into a second member of a surgical shaft-inner pedicle bone screw member joint, illustrated herein as a matching tapered socket 42 positioned within the surface 44 at the proximal end 45 of the inner member of a pedicle bone screw 36A, see FIG. 4. While the present invention describes the use of a locking taper and corresponding locking taper socket, other mechanisms to secure the surgical shaft to a portion of the screw may be used, including the threading and grooves or the use of male/female connectors.

[0041] The distal end 46 of the inner member of a modular pedicle bone screw 36A preferably contains a pointed tip end 48. As such, when the cannula 12 is placed over the surgical shaft 14, the tip end 48 of the inner member of a modular pedicle bone screw 36A forms the pointed end of the surgical instrument for implanting a modular pedicle screw 10, thus providing for the pointed tip to be useful in targeting an implant site, thereby forming a part of the actual implant. The pointed tip end 48 forms the center of the pedicle bone screw 36. The outer surface 50 of the inner member of a modular pedicle bone screw 36A contains a plurality of finely machined grooves 52 sized and shaped to interlock with a bone screw shaft 36B, see FIG. 3.

[0042] Referring to FIG. 5A, an illustrative example of the bone screw shaft 36B of the pedicle bone screw 36 is shown. The bone screw shaft 36B comprises a proximal end 54, a distal end 56, and a bone screw shaft main body 58. The bone screw shaft main body 58 is illustrated having a generally elongated, tubular shape sized to fit over the inner member of the modular pedicle bone screw 36A. Accordingly, the bone screw shaft main body 58 has a hollow or partially hollow interior 59 to allow for the inner member of the modular pedicle bone screw 36A to slidably engage therein. The distal end 56 has an opening 60 allowing the pointed end 48 of the inner member of the modular pedicle bone screw 36A to extend upwardly.

[0043] The interior surface 62 contains threading 64 which engages with and secures to the grooves 52 of the inner member of the modular pedicle bone screw 36A. Sliding the bone screw shaft 36B over the inner member of the modular pedicle bone screw 36A forms the solid bone screw 36. At the proximal end 54 of the bone screw shaft 36B is a connector member 66 which may be adapted to retain a screw set, locking cap, or spinal implant rod. The outer surface 68 contains a plurality of threading 70 to secure the modular pedicle bone screw 36 to the portion of the body inserted therein.

[0044] The present invention will further be defined by describing an illustrative example of method of use, see FIGS. 7-10. While the surgical instrument for implanting a modular pedicle screw is described for use in spinal implantation, such use is not intended to be limiting. As such, the surgical instrument for implanting a modular pedicle screw in accordance with the present invention can be adapted and used in any surgical procedure requiring screw implantation.

[0045] Referring to FIG. 7, the surgical instrument for implanting a modular pedicle screw 10 is shown inserted through the skin 72 of patient 74. To insert the surgical instrument for implanting a modular pedicle screw 10, the patient 74 is placed in a prone position according to standard surgical procedures. To aid in insertion of the surgical instrument for implanting a modular pedicle screw 10, imaging or guidance technology such as fluoroscopy, is utilized and positioned in according to standard surgical procedures. After the surgical site has undergone sterile preparation, the skin 72 is marked and an incision 76 is made. The surgical instrument for implanting a modular pedicle screw 10 is used under guidance to target and cannulate the target area, illustrated herein as the vertebral body 78. The surgical instrument for implanting a modular pedicle screw 10 is tapped to the desired depth within the vertebral body 78. Once securely in position to the desired depth, the cannula 12 of the surgical instrument for implanting a modular pedicle screw 10 is removed. To perform such procedure, the cap 28 is removed from the handle 24. The surgeon lifts the cannula 12 in a direction away from the patient 74, see arrows 80, FIG. 8. Once the cannula 12 is removed, the surgical shaft 14 with the inner member of the modular pedicle bone screw 36A remains embedded in the pedicle.

[0046] With the surgical shaft 14 firmly in place, the main body 34 of the surgical shaft 14 is used as a guide for placing the bone screw shaft 36B onto the inner member of the modular pedicle bone screw 36A, thereby forming the modular pedicle bone screw 36. The bone screw shaft 36B is cannulated to fit over and coaxially align with the already implanted inner member of the modular pedicle bone screw 36A. The inner threading 64 positioned within the interior surface 62 of the bone screw shaft 36B secures to and locks onto the finely machined grooves on the outer surface of the inner member of the modular pedicle bone screw 36A. Preferably, all components with threading have the same thread pitch to allow for the inner and outer components to move as a single unit. Once secured to each other, a solid pedicle screw 36 is formed and is comparable in strength to single, non-cannulated screws. The threading 70 on the outer surface 68 of the bone screw shaft 36B is screwed into place over the solid center thereby tapping the pedicle and allowing for removal as necessary as a standard screw.

[0047] The implanted main body 34 of the surgical shaft 14 may serve additional functions. The implanted main body 34 of the surgical shaft 14 may be utilized as a guide through which a cannulated screw head may be placed, either uni-planar or multi-planar. The implanted main body 34 of the surgical shaft 14 may also function as continued soft tissue retraction for visualization. Finally, the implanted main body 34 of the surgical shaft 14 may be used as a guide through which standard instruments are used to distract or compress the space according to surgical indications. Once the procedures are completed, the implanted main body 34 of the surgical shaft 14 is detached (such as through use of perforation within and around the surgical shaft perimeter, not shown or for example, constructing the detachable portion to have thinner diameter that breaks apart after a predetermined force, such as a predetermined bending force, is applied), leaving the pedicle screw implant 36 intact and in the proper, desired place.

[0048] The present invention further contemplates the use of a kit including one or more of the following: pre-assembled surgical instrument for implanting a modular pedicle screw and/or a plurality of individual components. FIG. 11 illustrates a first example of a kit in accordance with the present invention. The kit 82 includes a sterilizable case having the contents of at least one cannula 12, at least one surgical shaft with a locking member 38 unattached to an inner member of the pedicle screw 36A, a plurality of different sized inner member of the pedicle screws 36A, including 35 mm length 36A.sup.1, 40 mm length 36A.sup.2, 45 mm length 36A.sup.3, and correspondingly sized bone screw shafts 36B.sup.1, 36B.sup.2, and 36B.sup.3. In this arrangement, the surgeon secures the inner member of the modular pedicle bone screws 36A to the appropriately sized surgical shaft with a locking member 38 and cannula 12. FIG. 12 illustrates a kit 86 having a sterilizable case 84 having the contents of at least one cannula 12, a plurality of surgical shaft 14.sup.1, 14.sup.2, 14.sup.3 with differently sized inner members of the pedicle screw 36, and a plurality of and correspondingly sized bone screw shafts 36B.sup.1 36B.sup.2, and 36B.sup.3. FIG. 13 illustrates a kit 88 having a sterilizable case 84 having the contents of a plurality of surgical instrument for implanting a modular pedicle screw 10.sup.1, 10.sup.2, 10.sup.3, each pre-assembled and having differently sized inner members of the pedicle screw 36A, and a plurality of and correspondingly sized bone screw shafts 36B.sup.1 36B.sup.2, and 36B.sup.3.

[0049] All patents and publications mentioned in this specification are indicative of the levels of those skilled in the art to which the invention pertains. All patents and publications are herein incorporated by reference to the same extent as if each individual publication was specifically and individually indicated to be incorporated by reference.

[0050] It is to be understood that while a certain form of the invention is illustrated, it is not to be limited to the specific form or arrangement herein described and shown. It will be apparent to those skilled in the art that various changes may be made without departing from the scope of the invention and the invention is not to be considered limited to what is shown and described in the specification and any drawings/figures included herein.

[0051] One skilled in the art will readily appreciate that the present invention is well adapted to carry out the objectives and obtain the ends and advantages mentioned, as well as those inherent therein. The embodiments, methods, procedures and techniques described herein are presently representative of the preferred embodiments, are intended to be exemplary and are not intended as limitations on the scope. Changes therein and other uses will occur to those skilled in the art which are encompassed within the spirit of the invention and are defined by the scope of the appended claims. Although the invention has been described in connection with specific preferred embodiments, it should be understood that the invention as claimed should not be unduly limited to such specific embodiments. Indeed, various modifications of the described modes for carrying out the invention which are obvious to those skilled in the art are intended to be within the scope of the following claims.