System and method for precise prosthesis positioning in hip arthroplasty

• US 10,314,666 B2
• Filed: 02/17/2017
• Issued: 06/11/2019
• Est. Priority Date: 09/29/2011
• Status: Active Grant

• Current Assignee: Arthromeda, Inc.
• Original Assignee: Arthromeda, Inc.
• Inventors: Aghazadeh, Mehran S.
• Primary Examiner(s): Sevilla, Christian
• Application Number:
  US15/435,903
• Publication Number:
  US 20170172697A1
• Time in Patent Office: 844 Days
• CPC Class Codes: A61B 17/1659 Surgical rasps, files, planes, or scrapers
• CPC Class Codes: A61B 17/1668 for the upper femur A61B17/164 takes precedence
• CPC Class Codes: A61B 17/58 for osteosynthesis, e.g. bone plates, screws , setting implements or the like A61B17/14, A61B17/16 take precedence
• CPC Class Codes: A61B 17/60 for external osteosynthesis, e.g. distractors, contractors
• CPC Class Codes: A61B 2034/107 Visualisation of planned trajectories or target regions
• CPC Class Codes: A61B 2090/061 for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/067 for measuring angles
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• CPC Class Codes: A61B 90/36 Image-producing devices or illumination devices not otherwise provided for
• CPC Class Codes: A61B 90/37 Surgical systems with images on a monitor during operation
• CPC Class Codes: A61F 2/32 for the hip
• CPC Class Codes: A61F 2/34 Acetabular cups
• CPC Class Codes: A61F 2/36 Femoral heads ; Femoral endoprostheses
• 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 2/4607 of hip femoral endoprostheses
• CPC Class Codes: A61F 2/4609 of acetabular cups
• CPC Class Codes: A61F 2/4657 Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/30617 Visible markings for adjusting, locating or measuring
• CPC Class Codes: A61F 2002/4658 for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4668 for measuring angles

Abstract

Provided are systems and methods for precise intra-operative placement and positioning of components of hip prostheses, particularly with respect to avoiding acetabular prosthetic implant malpositioning in the human hip. In one embodiment the system includes at least a pair of electronic sensors as tilt and direction sensors, which are positioned on the patient'"'"'s native bone structure and the prosthesis, plus at least one of an electronic angle sensor and an electronic leg length measurement unit, plus a computer processor running application software that is capable of receiving and using information from the various electronic sensors to calculate relevant angular relationships and, optionally, distance relationships. The system electronically measures a living subject'"'"'s pelvic tilt and position while lying in the lateral decubitus position during the surgery. The systems and methods provide accurate and precise measurements of the subject'"'"'s pelvic tilt, angle of inclination, and angle of forward flexion to the surgeon during the procedure by which the hip prosthesis is surgically implanted into the subject.

Claims

1. A system for use in performing hip arthroplasty, comprising

a computer processor;

an axis guide, comprising a substantially linear rigid bar at least as long as a human subject'"'"'s pelvis is wide, constructed and arranged to have a slot at each end of the bar and at least two apertures adjacent and perpendicular to at least one of the slots, wherein each of the apertures is capable of receiving a pin guide and each pin guide is capable of receiving a securing pin;

a first electronic position sensor (ES1) capable of reporting information about its orientation in 3-dimensional space to the computer processor;

a second electronic position sensor (ES2) capable of reporting information about its orientation in 3-dimensional space to the computer processor; and

application software capable of (i) receiving information from the first electronic position sensor (ES1) and the second electronic position sensor (ES2) and (ii) calculating and causing to be displayed angular relationships derived from the first electronic position sensor and the second electronic position sensor.

2. The system of claim 1, further comprising an electronic visual display connected to the computer processor, wherein the visual display is capable of displaying the calculated angular relationships.

3. The system of claim 1, wherein at least one of the first electronic position sensor and the second electronic position sensor is capable of communicating wirelessly with the computer processor.

4. The system of claim 3, wherein each of the first electronic position sensor and the second electronic position sensor is capable of communicating wirelessly with the computer processor.

5. The system of claim 1, wherein the angular relationships comprise any one or more of:

(pelvic) axial tilt, (pelvic) anterior-posterior (AP) tilt, absolute angle of inclination, absolute angle of forward flexion, true angle of inclination, and true angle of forward flexion.

6. The system of claim 5, wherein the angular relationships comprise each of:

(pelvic) axial tilt, (pelvic) anterior-posterior (AP) tilt, absolute angle of inclination, absolute angle of forward flexion, true angle of inclination, and true angle of forward flexion.

7. The system of claim 1, wherein the calculating is performed on demand.

8. The system of claim 1, wherein the calculating is performed continuously in real time.

9. The system of claim 1, further comprising the at least two pin guides.

10. The system of claim 1, further comprising the at least two securing pins.

11. The system of claim 1, further comprising

a leg length measurement unit, comprising (i) a reflection pin configured to be attached to a human subject'"'"'s femur;

and (ii) an electronic distance sensor (DS) capable of being attached to the human subject'"'"'s pelvis and capable of reporting, to the computer processor, information about its distance from the reflection pin;

wherein the application software is further capable of (i) receiving information from the electronic distance sensor (DS); and

(ii) calculating and causing to be displayed leg length information derived from the distance sensor information.

12. The system of claim 1, further comprising:

an electronic angle sensor comprising an electronic angle sensor device connected via a pivot point to each of two rotatable arms, the first arm constructed and arranged to be inserted into a femoral neck, attached to a broach handle, or attached to a femoral stem, and the second arm comprising a light pointer aligned parallel to the long axis of said second arm;

wherein the electronic angle sensor device is capable of reporting information about angular relationship between the arms to the computer processor and the application software is capable of (i) receiving information from the electronic angle sensor; and

(ii) incorporating such information into the calculated and displayed angular relationships.

13. The system of claim 11, wherein the leg length measurement unit further comprises a substantially planar bracket constructed and arranged to receive at least two securing pins spaced and oriented in accordance with the apertures of the axis guide;

and

wherein the electronic distance sensor is configured to be attached to the bracket.

14. The system of claim 13, wherein the substantially planar bracket of the leg length measurement unit is a diapason (tuning fork)-shaped bracket having two fork ends and one handle end, wherein each of the two fork ends comprises a hole constructed and arranged to accept an exposed end of a securing pin, and the handle end is constructed and arranged to attach to the electronic distance sensor.

15. The system of claim 11, further comprising:

an electronic angle sensor comprising an electronic angle sensor device connected via a pivot point to each of two rotatable arms, a first arm of the two rotatable arms constructed and arranged to be inserted into a femoral neck, attached to a broach handle, or attached to a femoral stem, and a second arm of the two rotatable arms comprising a light pointer aligned parallel to the long axis of said second arm, wherein the electronic angle sensor device is capable of reporting information about angular relationship between the two rotatable arms to the computer processor;

wherein the application software is further capable of (i) receiving information from the electronic angle sensor; and

(ii) incorporating such information into the calculated and displayed angular relationships.

16. The system of claim 1, wherein the axis guide is further constructed and arranged to lie parallel to a human subject'"'"'s pelvic axis that is (i) parallel to a common line between a human subject'"'"'s transverse and coronal planes, or (ii) perpendicular to a human subject'"'"'s sagittal plane.

17. The system of claim 1, wherein the first electronic position sensor is configured to be attached to a human subject'"'"'s pelvis at an anterior superior iliac spine (ASIS).

18. A system for use in performing hip arthroplasty, comprising

a computer processor;

an axis guide, comprising a substantially linear rigid bar at least as long as a human subject'"'"'s pelvis is wide, constructed and arranged to have a slot at each end of the rigid bar and at least two apertures adjacent and perpendicular to at least one of the slots, wherein each of the at least two apertures is capable of receiving a pin guide and each pin guide is capable of receiving a securing pin;

a first electronic position sensor capable of reporting information about its orientation in 3-dimensional space to the computer processor;

a second electronic position sensor capable of reporting information about its orientation in 3-dimensional space to the computer processor; and

application software capable of (i) receiving information from the first electronic position sensor and the second electronic position sensor; and

(ii) calculating and causing to be displayed angular relationships derived from the information from the first electronic position sensor and the second electronic position sensor;

wherein the first electronic position sensor is configured to be attached to a bony pelvis and the second electronic position sensor is attached to a cup impactor that is in contact with an acetabular prosthetic cup.

19. The system of claim 18, further comprising:

an electronic angle sensor comprising an electronic angle sensor device connected via a pivot point to each of two rotatable arms, the first arm constructed and arranged to be inserted into a femoral neck, attached to a broach handle, or attached to a femoral stem, and the second arm comprising a light pointer aligned parallel to the long axis of said second arm;

wherein the electronic angle sensor device is capable of reporting information about angular relationship between the arms to the computer processor and the application software is capable of (i) receiving information from the electronic angle sensor; and

(ii) incorporating such information into the calculated and displayed angular relationships.

20. The system of claim 18, further comprising:

a leg length measurement unit, comprising (i) a reflection pin configured to be attached to a femur; and

(ii) an electronic distance sensor capable of being attached to the bony pelvis and capable of reporting, to the computer processor, information about its distance from the reflection pin;

wherein the application software is further capable of (i) receiving information from the electronic distance sensor; and

(ii) calculating and causing to be displayed leg length information derived from the information from the electronic distance sensor.

21. The system of claim 20, wherein the leg length measurement unit further comprises a substantially planar bracket constructed and arranged to receive at least two securing pins spaced and oriented in accordance with the apertures of the axis guide;

and

wherein the electronic distance sensor is configured to be attached to the bracket.

22. The system of claim 21, wherein the substantially planar bracket of the leg length measurement unit is a diapason (tuning fork)-shaped bracket having two fork ends and one handle end, wherein each of the two fork ends comprises a hole constructed and arranged to accept an exposed end of a securing pin, and the handle end is constructed and arranged to attach to the electronic distance sensor.