Surgical instrument and method of use for inserting an implant between two bones

• US 8,142,441 B2
• Filed: 10/16/2008
• Issued: 03/27/2012
• Est. Priority Date: 10/16/2008
• Status: Active Grant

• Current Assignee: Aesculap Implant Systems LLC (Sartorius AG)
• Original Assignee: Aesculap Implant Systems LLC (Sartorius AG)
• Inventors: Refai, Daniel, EBERSOLE, Jeffrey T., Farris, Jeffrey A.
• Primary Examiner(s): Stewart, Alvin J.
• Application Number:
  US12/252,552
• Publication Number:
  US 20100100100A1
• Time in Patent Office: 1,258 Days
• Field of Search: 623 1711- 1716, 606/86.R, 606 87- 99, 606/60, 606246-249, 606/279, 606/65, 606/280, 606/281, 606/287, 606/300
• US Class Current: 606/99
• CPC Class Codes: A61F 2/44 for the spine, e.g. vertebrae, spinal discs
• CPC Class Codes: A61F 2/4611 of spinal prostheses
• CPC Class Codes: A61F 2/4637 for connecting or disconnecting two parts of a prosthesis
• CPC Class Codes: A61F 2002/30471 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type
• CPC Class Codes: A61F 2002/30507 using a threaded locking member, e.g. a locking screw or a set screw
• CPC Class Codes: A61F 2002/30523 by means of meshing gear teeth
• CPC Class Codes: A61F 2002/3055 for adjusting length
• CPC Class Codes: A61F 2002/30616 Sets comprising a plurality of prosthetic parts of different sizes or orientations
• CPC Class Codes: A61F 2002/4622 having the shape of a forceps or a clamp
• CPC Class Codes: A61F 2002/4627 with linear motion along or rotating motion about the instrument axis or the implantation direction, e.g. telescopic, along a guiding rod, screwing inside the instrument
• CPC Class Codes: A61F 2002/4628 with linear motion along or rotating motion about an axis transverse to the instrument axis or to the implantation direction, e.g. clamping
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0091 connected by a hinged linkage mechanism, e.g. of the single-bar or multi-bar linkage type

Abstract

The surgical instrument includes a handle assembly and an elongate body that has first and second ends with the first end being located adjacent to the handle assembly and the second end being moveably connected to an implant engagement assembly. The surgical instrument also has a length control mechanism that includes a gripping portion, a drive shaft and a gear assembly. The surgical instrument further has a locking mechanism that includes a gripping portion, a connecting rod and a coupling end. The length control mechanism functions to adjust the overall length of an implant that is held by the implant engagement assembly before being implanted in vivo. The locking mechanism operates to secure the overall length of the implant following final length adjustment and implantation. A surgical method for using the surgical instrument, a method of fabrication and a spinal implant insertion kit is also disclosed.

Claims

1. A surgical instrument for inserting an implant between two bones, the surgical instrument comprising:

a handle assembly;

an elongate member having a first end and a second end, and a longitudinal axis extending there between, the elongate member being moveably connected to an implant engagement assembly, the implant engagement assembly being at a distal end of the surgical instrument and being configured to hold the implant; and

a length control mechanism for adjusting the overall length of the implant when the implant has been placed between the two bones, the length control mechanism comprising a gripping portion, a gear assembly and a drive shaft positioned intermediate the gripping portion and gear assembly, the drive shaft extending through an opening within the handle assembly and oriented substantially parallel to the longitudinal axis of the elongate member,

wherein upon movement of the elongate member relative to the implant engagement assembly, the implant engagement assembly adjusts the implant for insertion between the two bones.

2. The surgical instrument of claim 1, wherein the implant engagement assembly comprises an actuation body and a holding portion, the actuation body being operatively coupled to the second end of the elongate member, and the holding portion comprising a first arm and a second arm, the first arm and second arm being operatively coupled to the actuation body and configured to move and engage the implant upon actuation of the actuation body.

3. The surgical instrument of claim 2, wherein the first arm further comprises an engagement member and the second arm further comprises an engagement member, the engagement members being pivotally coupled to a distal position, the first arm and the second arm and are configured to operatively engage the implant upon activation of the actuation body.

4. The surgical instrument of claim 3, wherein the engagement member further comprises a distal surface, the distal surface having an engagement element disposed thereon, the engagement element being sized and configured to hold the implant in position after actuation of the actuation body.

5. The surgical instrument of claim 1, wherein the first end of the elongate member is configured as a gripping portion and the second end of the elongate member comprises external threads, the threads being sized and configured to threadingly engage the actuation body of the implant engagement assembly.

6. The surgical instrument of claim 1, wherein the elongate member is a cylindrical body.

7. The surgical instrument of claim 1, wherein the gear assembly is positioned proximate to the distal end of the surgical instrument and is configured to mate with a length adjustment mechanism in the implant, wherein when the gear assembly mates with the length adjustment mechanism and is rotated, the overall length of the implant is changed.

8. The surgical instrument of claim 1, further comprising a locking mechanism for fixing the overall length the implant after the implant has been placed between the two bones.

9. The surgical instrument of claim 8, wherein the locking mechanism comprises a gripping portion proximate to the proximal end of the surgical instrument, a coupling end and a connecting rod positioned intermediate the gripping portion and the coupling end, the connecting rod extends through an opening in the handle assembly and is oriented substantially parallel to the longitudinal axis of the elongate member.

10. The surgical instrument of claim 9, wherein the coupling end is configured to detachably couple a locking pin, the locking pin being sized and configured to be inserted into and secure the overall length of the implant after the implant has been placed between the two bones.

11. The surgical instrument of claim 9, wherein the coupling end is fabricated from a flexible material.

12. The surgical instrument of claim 8, wherein the locking mechanism is rotatable and moveable in a proximal to distal direction.

13. The surgical instrument of claim 1, wherein the surgical instrument further comprises a first locking mechanism and a second locking mechanism, wherein the first locking mechanism and second locking mechanism are substantially parallel to each other and to the longitudinal axis of the elongate member.

14. A surgical instrument for inserting a spinal implant between two vertebrae, the surgical instrument comprising:

a handle assembly;

an elongate member having a first end and a second end, and a longitudinal axis extending therebetween, the first end being adjacent to the handle assembly and the second end being rotationably connected to a spinal implant engagement assembly, the spinal implant engagement assembly being at a distal end of the surgical instrument;

a length control mechanism for adjusting the overall length of the spinal implant when the spinal implant has been placed between two vertebrae, the length control mechanism comprising a gripping portion, a gear assembly and a drive shaft positioned intermediate the gripping portion and gear assembly, the drive shaft extends through a first opening within the handle assembly and is oriented substantially parallel to the longitudinal axis of the elongate member; and

a first locking mechanism for securing the overall length of the spinal implant after the spinal implant has been placed between the two vertebrae, the first locking mechanism comprises a gripping portion proximate to the proximal end of the surgical instrument, a coupling end and a connecting rod positioned intermediate the gripping portion and the coupling end, the connecting rod extends through a second opening in the handle assembly and is oriented substantially parallel to the longitudinal axis of the elongate member.

15. The surgical instrument of claim 14, wherein the spinal implant engagement assembly further comprises an actuation body and a holding portion, the actuation body being operatively coupled to the second end of the elongate member, and the holding portion comprising a first arm and a second arm, the first arm and second arm being operatively coupled to the actuation body and configured to move and engage the spinal implant upon actuation of the actuation body.

16. The surgical instrument of claim 15, wherein the first arm further comprise an engagement member and the second arm further comprises an engagement member, the engagement members being pivotally coupled to a distal portion of the first arm and the second arm and are configured to operatively engage the spinal implant upon activation of the actuation body.

17. The surgical instrument of claim 16, wherein the engagement member further comprises a distal surface, the distal surface having an engagement element disposed thereon, the engagement element being sized and configured to hold the spinal implant in position after actuation of the actuation body.

18. The surgical instrument of claim 14, wherein the first end of the elongate member is configured as a gripping portion and the second end of the elongate member comprises external threads, the threads being sized and configured to threadingly engage the actuation body of the spinal implant engagement assembly.

19. The surgical instrument of claim 14, wherein the elongate member is a cylindrical body.

20. The surgical instrument of claim 14, wherein the gear assembly of the length control mechanism is positioned proximate to the distal end of the surgical instrument and is configured to mate with a length adjustment mechanism in the spinal implant, wherein when where the gear assembly mates with the length adjustment mechanism and is rotated, the overall length of the implant is changed.

21. The surgical instrument of claim 14, wherein the coupling end of the first locking mechanism is positioned proximate the distal end of the surgical instrument and is configured to detachably couple a locking pin, the locking pin being sized and configured to be inserted into and secure the overall length of the spinal implant after the spinal implant has been placed between the two vertebrae.

22. The surgical instrument of claim 14, wherein the surgical instrument further comprises a second locking mechanism, wherein the second locking mechanism is substantially parallel to the first locking mechanism and to the longitudinal axis of the elongate member.

23. The surgical instrument of claim 14, wherein the first locking mechanism is rotatable and moveable in a proximal to distal direction.

24. The surgical instrument of claim 14, wherein the coupling end of the first locking mechanism is fabricated from a flexible material.

25. A surgical method of inserting an implant between two bones, the method comprising:

surgically creating an opening on the skin of a patient, wherein the opening is proximate the location of the two bones;

obtaining a surgical instrument comprising;

a handle assembly;

an elongate member having a first end and a second end, and a longitudinal axis extending therebetween, the first end being adjacent to the handle assembly and the second end being moveably connected to an implant engagement assembly, the implant engagement assembly being at a distal end of the surgical instrument;

a length control mechanism for adjusting the length of the implant when the implant has been placed between two bones, the length control mechanism comprising a gripping portion, a gear assembly and a drive shaft positioned intermediate the gripping portion and gear assembly, the drive shaft extends through a first opening within the handle assembly and is oriented substantially parallel to the longitudinal axis of the elongate member; and

at least one locking mechanism for securing the overall length of the implant after the implant has been placed between the two bones, the at least one locking mechanism having a gripping portion proximate to the proximal end of the surgical instrument, a coupling end and a connecting rod positioned intermediate the gripping portion and the coupling end, the connecting rod extending through a second opening in the handle assembly and is oriented substantially parallel to the longitudinal axis of the elongate member, coupling the implant to the implant engagement assembly;

inserting the surgical instrument and coupled implant into the opening;

positioning the implant into a space between the two bones;

extending the implant to an overall length and causing the implant to contact and apply a force to the two bones to maintain the space between the two bones; and

fixing the overall length of the inserted implant.

26. The method of claim 25, wherein the extending the implant further comprises employing the length control mechanism by mating the gear assembly with a length adjustment mechanism in the implant and changing the overall length of the implant by rotating the mated gear assembly.

27. The method of claim 25, wherein the fixing the overall length of the inserted implant further comprises employing the at least one locking mechanism and inserting the locking pin into the implant, thereby securing the overall length of the implant between the two bones.

28. A method of fabricating a surgical instrument for inserting an implant between two bones, the method comprising:

providing a handle assembly;

providing an elongate member having a first end and a second end, and a longitudinal axis extending there between, the first end being positioned adjacent handle assembly and the second end being moveably connected to an implant engagement assembly, the implant engagement assembly being at a distal end of the surgical instrument; and

providing a length control mechanism for adjusting the overall length of the implant when the implant has been placed between two bones, the length control mechanism comprising a gripping portion, a gear assembly and a drive shaft positioned intermediate the gripping portion and gear assembly, the drive shaft extending through a first opening within the handle assembly and oriented substantially parallel to the longitudinal axis of the elongate member,

wherein upon movement of the elongate member relative to the handle assembly and implant engagement assembly, the implant engagement assembly couples the implant for insertion between the two bones.

29. The method of claim 28, further comprising providing at least one locking mechanism for securing the overall length of the implant after the implant has been placed between the two bones, the at least one locking mechanism having a gripping portion proximate to the proximal end of the surgical instrument, a coupling end and a connecting rod positioned intermediate the gripping portion and the coupling end, the connecting rod extending through a second opening in the handle assembly and is oriented substantially parallel to the longitudinal axis of the elongate member.

30. The method of claim 29, wherein providing at least one locking mechanism further comprises fabricating the coupling end from at least one of a flexible metal and polymer.

31. A spinal implant insertion kit, the kit comprising:

a spinal implant for placement between two vertebrae; and

a surgical instrument comprising;

a handle assembly;

an elongate member having a first end and a second end, and a longitudinal axis extending therebetween, the first end being adjacent to the handle assembly and the second end being moveably connected to a spinal implant engagement assembly, the spinal implant engagement assembly being at a distal end of the surgical instrument;

a length control mechanism for adjusting the length of the spinal implant when the spinal implant has been placed between the two vertebrae, the length control mechanism comprising a gripping portion, a gear assembly and a drive shaft positioned intermediate the gripping portion and gear assembly, the drive shaft extends through a first opening within the handle assembly and is oriented substantially parallel to the longitudinal axis of the elongate member; and

at least one locking mechanism for securing the overall length of the spinal implant after the spinal implant has been placed between the two bones, the at least one locking mechanism having a gripping portion proximate to the proximal end of the surgical instrument, a coupling end and a connecting rod positioned intermediate the gripping portion and the coupling end, the connecting rod extending through a second opening in the handle assembly and is oriented substantially parallel to the longitudinal axis of the elongate member.