Prosthesis installation systems and methods

• US 10,610,379 B2
• Filed: 04/05/2017
• Issued: 04/07/2020
• Est. Priority Date: 12/29/2013
• Status: Active Grant

• Current Assignee: Kambiz Behzadi
• Original Assignee: Kambiz Behzadi
• Inventors: Behzadi, Kambiz
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US15/479,716
• Publication Number:
  US 20170202683A1
• Time in Patent Office: 1,098 Days
• CPC Class Codes: A61F 2/46 Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
• CPC Class Codes: A61F 2/4603 for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4609 of acetabular cups
• CPC Class Codes: A61F 2/4637 for connecting or disconnecting two parts of a prosthesis
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2/481 Acoustic or audible means
• CPC Class Codes: A61F 2002/4619 for extraction
• CPC Class Codes: A61F 2002/4632 using computer-controlled surgery, e.g. robotic surgery
• CPC Class Codes: A61F 2002/4666 for measuring force, pressure or mechanical tension
• CPC Class Codes: A61F 2002/4668 for measuring angles
• CPC Class Codes: A61F 2002/4681 by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2002/4683 by applying ultrasonic vibrations
• CPC Class Codes: A61F 2002/4694 pneumatic

Abstract

A system and method for allowing any surgeon, including those surgeons who perform a fewer number of a revision procedure as compared to a more experienced surgeon who performs a greater number of procedures, to provide an improved likelihood of a favorable outcome approaching, if not exceeding, a likelihood of a favorable outcome as performed by a very experienced surgeon with the revision procedure. An engine is operable in two distinctive selectable modes including a unidirectional mode providing only extractive forces and a bidirectional mode providing both extractive and insertional forces.

Claims

1. An installation device for an acetabular cup for installation in a pelvic bone, the acetabular cup including an outer shell having a sidewall defining an inner cavity and an opening with the sidewall having a periphery around the opening and with the acetabular cup having a desired installation depth relative to the bone, a desired abduction angle relative to the bone, and a desired anteversion angle relative to the bone, comprising:

a controller including a trigger initiating an actuation event;

a support having a proximal end and a distal end opposite of said proximal end, said support further having a longitudinal axis extending from said proximal end to said distal end with said proximal end coupled to said controller, said support further having an adapter coupled to said distal end with said adapter configured to secure the acetabular cup to said support; and

a pulse generator coupled to said controller and to said support, said pulse generator configured to control a set of vibratory pulses including a pulse profile of said support with said pulse profile configured to install the acetabular cup at the installation depth with the desired abduction angle and the desired anteversion angle responsive to said set of vibratory pulses wherein said set of vibratory pulses includes a series of two or more vibratory pulses responsive applied responsive to each said actuation event.

2. The installation device of claim 1 wherein said support includes any of one to six degrees of freedom, and combinations thereof, relative to an X-axis, a Y-axis, and a Z-axis, wherein said set of vibratory pulses includes a subset of vibratory pulses having an oscillation frequency and an oscillation magnitude, wherein said pulse generator includes an oscillator producing said subset of vibratory pulses and wherein said oscillation magnitude includes one or more oscillation directions selected from the group consisting of a translation direction, a rotation direction, an X-axis translation direction, a Y-axis translation, a Z-axis translation, a pitch direction about said X-axis, a yaw direction about said Y-axis, a roll direction about said Z-axis, and combinations thereof.

3. The installation device of claim 1 wherein said set of vibratory pulses includes a vibratory motion having a frequency greater than or equal to about 20 kHz.

4. The installation device of claim 1 wherein said controller includes a processor coupled to a memory storing program instructions that when executed by said processor select a triggering set of one or more of said longitudinal actuators and trigger said triggering set of longitudinal actuators according to an adjustment profile that produces the desired abduction angle relative to the bone and the desired anteversion angle relative to the bone.

5. The installation device of claim 1 wherein said set of vibratory pulses are configured to produce a float of the acetabular cup during installation of the acetabular cup, said float including an alignment adjustment concurrent with an insertion depth adjustment of the acetabular cup.

6. An installation system for a prosthesis configured to be installed into a portion of bone at a desired installation depth, the prosthesis including an attachment system, comprising:

an oscillation engine including a controller coupled to a vibratory machine generating an original set of pulses having a generation pattern, said generation pattern defining a first duty cycle of said original set of pulses; and

a pulse transfer assembly having a proximal end coupled to said oscillation engine and a distal end, spaced from said proximal end, coupled to the prosthesis with said pulse transfer assembly including a connector system at said proximal end, said connector system complementary to the attachment system and configured to secure and rigidly hold the prosthesis producing a secured prosthesis with said pulse transfer assembly communicating an installation set of pulses, responsive to said original set of pulses, to said secured prosthesis producing an applied set of ultrasonic pulses responsive to said installation set of pulses;

wherein said applied set of ultrasonic pulses are configured to impart a vibratory motion to said secured prosthesis enabling an installation of said secured prosthesis into the portion of bone to within 95% of the desired implantation depth.

7. The installation system of claim 6 wherein said pulse transfer assembly receives said original set of pulses from said oscillation engine and produces, responsive to said original set of pulses, an installation set of pulses having an installation pattern, said installation pattern defining a second duty cycle of said installation set of pulses including a second pulse amplitude, a second pulse direction, a second pulse duration, and a second pulse time window with said pulse transfer assembly communicating said installation set of pulses to said secured prosthesis producing said applied set of ultrasonic pulses responsive to said installation set of pulses.

8. The installation system of claim 7 wherein said pulse transfer assembly includes a body and an elongate vibration assembly having a proximal end and a distal end opposite of said proximal end, said proximal disposed within said body and coupled to said oscillation engine with said distal end extending outside said body and including said connector system;

said elongate vibration assembly configured to move relative to said body and having one or more degrees of freedom.

9. The installation system of claim 6 wherein said pulse transfer assembly includes a body and an elongate vibration assembly having a proximal end and a distal end opposite of said proximal end, said proximal disposed within said body and coupled to said oscillation engine with said distal end extending outside said body and including said connector system;

said elongate vibration assembly configured to move relative to said body and having one or more degrees of freedom.

10. A method for installing an acetabular cup into a prepared socket in a pelvic bone, the acetabular cup including an outer shell having a sidewall defining an inner cavity and an opening with the sidewall having a periphery around the opening and with the acetabular cup having a desired installation depth relative to the bone, a desired abduction angle relative to the bone, and a desired anteversion angle relative to the bone, comprising:

(a) generating an original set of pulses from an oscillation engine;

(b) communicating said original set of pulses to the acetabular cup producing a communicated set of pulses at said acetabular cup;

(c) vibrating, responsive to said communicated set of pulses, the acetabular cup to produce a vibrating acetabular cup having a predetermined vibration pattern; and

(d) inserting the vibrating acetabular cup into the prepared socket within a first predefined threshold of the installation depth with the desired abduction angle and the desired anteversion angle.

11. The method of claim 10 further comprising:

(e) orienting the vibrating acetabular cup within the prepared socket within a second predetermined threshold of the desired abduction angle and within third predetermined threshold of the desired anteversion angle.

12. A method for inserting an implant into a prepared location in a bone of a patient at a desired insertion depth wherein non-vibratory insertion forces for inserting the prosthesis to the desired insertion depth are in a first range, the method comprising:

(a) vibrating the implant using a tool to produce a vibrating implant having a predetermined vibration pattern including an oscillation; and

(b) inserting the vibrating implant into the prepared location to within a first predetermined threshold of the desired insertion depth using vibratory insertion forces in a second range, said second range including a set of values less than a lowest value of the first range.

13. The method of claim 12 wherein said second range is less than first range.

14. The method of claim 12 wherein the implant includes a desired orientation relative to the bone, further comprising:

(c) orienting the vibrating implant to within a second predetermined threshold of the desired orientation using the tool.

15. The method of claim 14 wherein said inserting step (b) includes:

(b1) determining automatically, using an automated depth determining tool, a current insertion depth of said vibrating implant; and

(b2) increasing automatically, using an intraoperative robotic tool, said current insertion depth until said current depth is within said first predetermined threshold.

16. The method of claim 14 wherein said orienting step (c) includes:

(c1) determining automatically, using an automated orientation determining tool, a current insertion orientation of said vibrating implant; and

(c2) adjusting automatically, using an intraoperative robotic tool, said current insertion orientation until said current insertion orientation is within said second predetermined threshold.

17. The method of claim 16 wherein said orienting step (c) includes:

(c1) determining automatically, using an automated orientation determining tool, a current insertion orientation of said vibrating implant; and

(c2) adjusting automatically, using an intraoperative robotic tool, said current insertion orientation until said current insertion orientation is within said second predetermined threshold.

18. The method of claim 17 wherein the implant includes an acetabular cup prosthesis.

19. The method of claim 12 wherein said inserting step (b) includes:

(b1) determining automatically, using an automated depth determining tool, a current insertion depth of said vibrating prosthesis; and

(b2) increasing automatically, using an intraoperative robotic tool, said current insertion depth until said current depth is within said first predetermined threshold.

20. The method of claim 12 wherein said vibrating implants includes a vibration having an ultrasonic oscillation.

21. An apparatus for inserting an implant into a prepared location in a bone of a patient at a desired insertion depth wherein non-vibratory insertion forces for inserting the prosthesis to the desired insertion depth are in a first range, the apparatus comprising:

means for vibrating the implant to produce a vibrating implant having a predetermined vibration pattern including an oscillation; and

means for inserting the vibrating implant into the prepared location to within a first predetermined threshold of the desired insertion depth using vibratory insertion forces in a second range, said second range including a set of values less than a lowest value of the first range.

22. A device for assisting with an installation of an acetabular cup into a pelvic bone, the acetabular cup including an outer shell having a sidewall defining an inner cavity and an opening with the sidewall having a periphery around the opening and with the acetabular cup having a desired installation depth relative to the bone, a desired abduction angle relative to the bone, and a desired anteversion angle relative to the bone, comprising:

a controller including an initiation control; and

a pulse transfer mechanism, coupled to said controller and responsive to said initiation control, said pulse transfer mechanism configured to;

generate a first series of pulses having a first pulse profile;

produce a second series of pulses from said first series of pulses, said second series of pulses having a second pulse profile different from said first pulse profile including a set of vibratory pulses; and

apply said second series of pulses to the acetabular cup.

23. The device of claim 22 wherein said first pulse profile includes a first pulse application frequency, and wherein said second pulse profile includes a second pulse application frequency desynchronized from said first application frequency.

24. The device of claim 23 wherein said first pulse profile includes a first pulse application magnitude, and wherein said second pulse profile includes a second pulse application magnitude mechanically buffered from said first application magnitude.

25. The device of claim 22 wherein said first pulse profile includes a first pulse application magnitude, and wherein said second pulse profile includes a second pulse application magnitude mechanically buffered from said first application magnitude.

26. An installation device for an acetabular cup for installation in a pelvic bone, the acetabular cup including an outer shell having a sidewall defining an inner cavity and an opening with the sidewall having a periphery around the opening, comprising:

a controller including a trigger initiating an actuation event;

a support having a proximal end and a distal end opposite of said proximal end, said support further having a longitudinal axis extending from said proximal end to said distal end with said proximal end coupled to said controller, said support further having an adapter coupled to said distal end with said adapter configured to secure the acetabular cup to said support; and

a pulse generator coupled to said controller and to said support, said pulse generator configured to control a set of vibratory pulses including a pulse profile of said support with said pulse profile configured to install the acetabular cup at an installation depth with a desired abduction angle and a desired anteversion angle responsive to said set of vibratory pulses;

wherein said support includes any of one to six degrees of freedom, and combinations thereof, relative to an X-axis, a Y-axis, and a Z-axis, wherein said set of vibratory pulses includes a subset of vibratory pulses having an oscillation frequency and an oscillation magnitude, wherein said pulse generator includes an oscillator producing said subset of vibratory pulses and wherein said oscillation magnitude includes one or more oscillation directions selected from the group consisting of a translation direction, a rotation direction, an X-axis translation direction, a Y-axis translation, a Z-axis translation, a pitch direction about said X-axis, a yaw direction about said Y-axis, a roll direction about said Z-axis, and combinations thereof.