Prosthesis installation systems and methods

• US 10,172,722 B2
• Filed: 02/29/2016
• Issued: 01/08/2019
• Est. Priority Date: 12/29/2013
• Status: Active Grant

• Current Assignee: Kambiz Behzadi
• Original Assignee: Kambiz Behzadi
• Inventors: Behzadi, Kambiz, Leite, Alexandre Carvalho
• Primary Examiner(s): Yang, Andrew
• Application Number:
  US15/055,942
• Publication Number:
  US 20160175110A1
• Time in Patent Office: 1,044 Days
• CPC Class Codes: A61B 17/1666 for the acetabulum
• CPC Class Codes: A61F 2/4609 of acetabular cups
• 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 2002/4694 pneumatic

Abstract

A system and method for allowing any surgeon, including those surgeons who perform a fewer number of a replacement 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 replacement procedure.

Claims

1. An apparatus, comprising:

a prosthetic tool; and

a set of sensors mechanically coupled to said prosthetic tool, said set of sensors including one or more structures selected from the group consisting essentially of one or more accelerometers, one or more gyro meters, and combinations thereof wherein said prosthetic tool includes a housing, further comprising;

an alignment system mechanically coupled to said housing, wherein said alignment system incudes said set of sensors and a feedback system configured to provide an alignment variation indication during operation wherein said prosthetic tool includes a mounting system securing a prosthesis and wherein said housing contains an oscillation motor configured to vibrate said mounting system with a predetermined vibration profile.

2. An installation device for an acetabular cup disposed 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;

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;

an oscillator coupled to said controller and to said support, said oscillator configured to control a series of vibratory pulses having an oscillation frequency and an oscillation magnitude of said support with said oscillation frequency and said oscillation magnitude configured to install the acetabular cup at the installation depth with the desired abduction angle and the desired anteversion angle responsive to said series of vibratory pulses; and

an alignment system mechanically coupled to said support, wherein said alignment system includes a set of sensors and a feedback system configured to provide a direct real-time alignment variation indication during operation.

3. The installation device of claim 2 wherein said support includes one to six degrees of freedom relative to an X-axis, a Y-axis, and a Z-axis, 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.

4. The installation device of claim 2 wherein said series of vibratory pulses includes a vibratory motion having a frequency greater than or equal to about 20 kHz.

5. 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 series of pulses having a generation pattern, said generation pattern defining a first duty cycle of said original series of pulses;

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 series of pulses, responsive to said original series of pulses, to said secured prosthesis producing an applied series of ultrasonic pulses responsive to said installation series of pulses; and

an alignment system mechanically coupled to said support, wherein said alignment system includes a set of sensors and a feedback system configured to provide a direct real-time alignment variation indication during operation;

wherein said applied series 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.

6. The installation system of claim 5 wherein said pulse transfer assembly receives said original series of pulses from said oscillation engine and produces, responsive to said original series of pulses, an installation series of pulses having an installation pattern, said installation pattern defining a second duty cycle of said installation series 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 series of pulses to said secured prosthesis producing said applied series of ultrasonic pulses responsive to said installation series of pulses.

7. The installation system of claim 5 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.

8. 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.

9. 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 series of pulses from an oscillation engine included in a prosthetic tool;

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

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

(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; and

(e) monitoring directly a real-time alignment system coupled mechanically to said prosthetic tool to produce an installed alignment for the acetabular cup at a desired alignment with respect to the pelvic bone.

10. The method of claim 9 further comprising:

(f) orienting, responsive to a feedback system of said alignment system, 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.

11. A method for inserting an implant into a prepared location in a live bone of a patient at a desired insertion depth at a desired relative alignment 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;

(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; and

(c) aligning the vibrating implant to within a second threshold of the desired relative alignment using a direct view real-time alignment system mechanically coupled to said tool.

12. The method of claim 11 wherein said second range is less than first range.

13. The method of claim 11 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.

14. The method of claim 11 wherein the implant includes an acetabular cup prosthesis.

15. The method of claim 11 wherein said vibrating implants includes a vibration having an ultrasonic oscillation.