System and method for joint resurface repair

• US 20030120276A1
• Filed: 02/06/2003
• Published: 06/26/2003
• Est. Priority Date: 05/01/2000
• Status: Active Grant

• Current Assignee: Arthrosurface, Inc (Anika Therapeutics Incorporated)
• Original Assignee: Arthrosurface, Inc (Anika Therapeutics Incorporated)
• Inventors: Ek, Steven W., Tallarida, Steven J.
• Granted Patent: US 7,029,479 B2
• Time in Patent Office: Days
• US Class Current: 606/61
• CPC Class Codes: A61B 1/317 for bones or joints, e.g. osteoscopes, arthroscopes
• CPC Class Codes: A61B 17/0401 Suture anchors, buttons or pledgets, i.e. means for attaching sutures to bone, cartilage or soft tissue; Instruments for applying or removing suture anchors A61B17/0642 takes precedence; fixation devices for tendons or ligaments A61F2/0811
• CPC Class Codes: A61B 17/0487 Suture clamps, clips or locks, e.g. for replacing suture knots; Instruments for applying or removing suture clamps, clips or locks suture anchors A61B17/0401; wound clamps or clips A61B17/08; ligaturing clamps or clips A61B17/122
• CPC Class Codes: A61B 17/06166 Sutures suture materials A61L17/00; manufacture of artificial threads D01D; treatment of threads D06M
• CPC Class Codes: A61B 17/16 Bone cutting, breaking or removal means other than saws, e.g. Osteoclasts; Drills or chisels for bones; Trepans arthroscopic bone cutters A61B17/320016; dental implant drills potentially for other surgical use A61C8/0089; bone grinders A61F2/4644, A22C17/06; A61B17/1662 takes precedence over all other subgroups except A61B17/17
• CPC Class Codes: A61B 17/1615 Drill bits, i.e. rotating tools extending from a handpiece to contact the worked material
• CPC Class Codes: A61B 17/1635 for grafts, harvesting or transplants
• CPC Class Codes: A61B 17/1637 Hollow drills or saws producing a curved cut, e.g. cylindrical A61B10/025, A61B17/1695 take precedence
• CPC Class Codes: A61B 17/1675 for the knee
• CPC Class Codes: A61B 17/1764 for the knee
• CPC Class Codes: A61B 17/7098 wherein the implant is permeable or has openings, e.g. fenestrated screw hollow surgical screws A61B17/864
• CPC Class Codes: A61B 17/8615 at the central region of the screw head
• CPC Class Codes: A61B 17/8625 Shanks, i.e. parts contacting bone tissue
• CPC Class Codes: A61B 17/863 with thread interrupted or changing its form along shank, other than constant taper
• CPC Class Codes: A61B 17/8695 Washers surrounding screw head in plate hole A61B17/8047, between bone plate and bone A61B17/8028
• CPC Class Codes: A61B 17/8805 for introducing fluid filler into bone or extracting it A61B17/7097, A61B17/8833 take precedence
• CPC Class Codes: A61B 17/8827 with filtering, degassing, venting or pressure relief means
• CPC Class Codes: A61B 17/8875 Screwdrivers, spanners or wrenches
• CPC Class Codes: A61B 17/888 the driver bit acting on the central region of the screw head
• CPC Class Codes: A61B 17/8894 holding the implant into or through which the screw is to be inserted A61B17/7082, A61B17/7091 take precedence
• CPC Class Codes: A61B 2017/00238 : Type of minimally invasive operation A61B2017/00805 takes precedence
• CPC Class Codes: A61B 2017/00464 : for use with different instruments with hole for different instruments A61B2017/22072
• CPC Class Codes: A61B 2017/0404 : Buttons
• CPC Class Codes: A61B 2017/0409 : Instruments for applying suture anchors for applying suture clamps, clips or locks A61B2017/0488
• CPC Class Codes: A61B 2017/044 : with a threaded shaft, e.g. screws
• CPC Class Codes: A61B 2017/0445 : cannulated, e.g. with a longitudinal through-hole for passage of an instrument
• CPC Class Codes: A61B 2017/0448 : Additional elements on or within the anchor
• CPC Class Codes: A61B 2017/045 : snug fit within the anchor
• CPC Class Codes: A61B 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 5/1076 : for measuring dimensions inside body cavities, e.g. using catheters A61B3/1005 takes precedence
• CPC Class Codes: A61B 5/4528 : Joints A61B5/4533, A61B5/4538 take precedence
• CPC Class Codes: A61B 90/06 : Measuring instruments not otherwise provided for
• CPC Class Codes: A61F 2/30756 : Cartilage endoprostheses A61F2/3603 takes precedence
• CPC Class Codes: A61F 2/30767 : Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
• CPC Class Codes: A61F 2/30942 : for designing or making customized prostheses, e.g. using templates, CT or NMR scans, finite-element analysis or CAD-CAM techniques
• CPC Class Codes: A61F 2/38 : for elbows or knees
• CPC Class Codes: A61F 2/3859 : Femoral components
• CPC Class Codes: A61F 2/4603 : for insertion or extraction of endoprosthetic joints or of accessories thereof
• CPC Class Codes: A61F 2/4618 : of cartilage
• CPC Class Codes: A61F 2/4657 : Measuring instruments used for implanting artificial joints for surgical instruments A61B90/06
• CPC Class Codes: A61F 2002/30065 : thermoplastic, i.e. softening or fusing when heated, and hardening and becoming rigid again when cooled
• CPC Class Codes: A61F 2002/30069 : elastomeric
• CPC Class Codes: A61F 2002/30113 : circular
• CPC Class Codes: A61F 2002/30143 : hexagonal
• CPC Class Codes: A61F 2002/30225 : Flat cylinders, i.e. discs
• CPC Class Codes: A61F 2002/30299 : umbrella-shaped or mushroom-shaped
• CPC Class Codes: A61F 2002/30324 : differing in thickness
• CPC Class Codes: A61F 2002/30332 : Conically- or frustoconically-shaped protrusion and recess
• CPC Class Codes: A61F 2002/30354 : Cylindrically-shaped protrusion and recess, e.g. cylinder of circular basis
• CPC Class Codes: A61F 2002/30433 : using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
• CPC Class Codes: A61F 2002/30448 : using adhesives
• CPC Class Codes: A61F 2002/30451 : soldered or brazed or welded
• CPC Class Codes: A61F 2002/30604 : modular
• CPC Class Codes: A61F 2002/30772 : Apertures or holes, e.g. of circular cross section
• CPC Class Codes: A61F 2002/30831 : perpendicular with respect to each other
• CPC Class Codes: A61F 2002/30858 : Threads interrupted by grooves or sidewalls, e.g. flat sidewalls
• CPC Class Codes: A61F 2002/30871 : Trapezoidal threads
• CPC Class Codes: A61F 2002/30873 : Threadings machined on non-cylindrical external surfaces
• CPC Class Codes: A61F 2002/30878 : with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts
• CPC Class Codes: A61F 2002/30879 : Ribs
• CPC Class Codes: A61F 2002/30892 : parallel
• CPC Class Codes: A61F 2002/30896 : perpendicular with respect to each other
• CPC Class Codes: A61F 2002/30943 : using mathematical models
• CPC Class Codes: A61F 2002/30948 : using computerized tomography, i.e. CT scans
• CPC Class Codes: A61F 2002/30952 : using CAD-CAM techniques or NC-techniques
• CPC Class Codes: A61F 2002/30957 : using a positive or a negative model, e.g. moulds
• CPC Class Codes: A61F 2002/4635 : using minimally invasive surgery
• CPC Class Codes: A61F 2002/4658 : for measuring dimensions, e.g. length
• CPC Class Codes: A61F 2002/4661 : for measuring thickness
• CPC Class Codes: A61F 2002/4663 : for measuring volumes or other three-dimensional shapes
• CPC Class Codes: A61F 2002/4681 : by applying mechanical shocks, e.g. by hammering
• CPC Class Codes: A61F 2210/0071 : thermoplastic
• CPC Class Codes: A61F 2220/0033 : made by longitudinally pushing a protrusion into a complementary-shaped recess, e.g. held by friction fit
• CPC Class Codes: A61F 2220/0041 : using additional screws, bolts, dowels or rivets, e.g. connecting screws
• CPC Class Codes: A61F 2220/005 : using adhesives
• CPC Class Codes: A61F 2220/0058 : soldered or brazed or welded
• CPC Class Codes: A61F 2230/0006 : circular
• CPC Class Codes: A61F 2230/0017 : Angular shapes
• CPC Class Codes: A61F 2230/0069 : cylindrical
• CPC Class Codes: A61F 2230/0093 : Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61F 2250/0036 : differing in thickness
• CPC Class Codes: A61F 2310/00017 : Iron- or Fe-based alloys, e.g. stainless steel
• CPC Class Codes: A61F 2310/00023 : Titanium or titanium-based alloys, e.g. Ti-Ni alloys
• CPC Class Codes: A61F 2310/00029 : Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium
• CPC Class Codes: A61F 2310/00059 : Chromium or Cr-based alloys
• CPC Class Codes: A61F 2310/00089 : Zirconium or Zr-based alloys
• CPC Class Codes: A61F 2310/00095 : Niobium or Nb-based alloys
• CPC Class Codes: A61F 2310/00203 : containing alumina or aluminium oxide
• CPC Class Codes: A61F 2310/00239 : containing zirconia or zirconium oxide ZrO2
• CPC Class Codes: A61F 2310/00796 : Coating or prosthesis-covering structure made of a phosphorus-containing compound, e.g. hydroxy(l)apatite
• CPC Class Codes: Y10S 606/902 : Cortical plate specifically adapted for a particular bone
• CPC Class Codes: Y10S 606/907 : Composed of particular material or coated
• CPC Class Codes: Y10S 606/91 : Polymer

Abstract

The present invention provides tools and methods for mapping and measuring the articular surface of a joint (or of any bony surface) and for fabricating a prosthetic device based on this recorded data. In one embodiment, once the defect of the chondral surface has been identified, a guide pin is inserted arthroscopically. A fixation screw is driven into the subchondral bone in relation to a reference axis that is approximately central to the defect, the fixation device also serving to define a tangent point to the surrounding articular surface. A further cylindrical proximal extension of the screw that eventually serves as a fixation element for the surface prosthetic is concealed with a cover or plug. The depth positioning of the cover or plug establishes an origin or reference point for all future measuring, cutting, and prosthetic machining operations. A measuring tool having a static post that establishes the axial location of origin is inserted on the reference axis. By rotating the outer arm or outrigger of the measuring tool relative to the static post while also maintaining contact with the articular surface, an axial displacement or Z dimension is established relative to the origin for any point along the known radial sweep of the outrigger to determine the final geometry of the prosthetic surface which fits within the defect. Data recorded during the mapping procedure is entered into parametric engineering design software or similar algorithm to define a three dimensional surface matched to the bearing surface geometry to be implanted and reproduce the anatomic contours mapped.

Claims

1. A method for fabricating an implant for installation into an articular surface, said method comprising:

mapping the contours of said articular surface; and

fabricating an implant based on said contours.

2. A method as claimed in claim 1, wherein said mapping step further comprises:

establishing a working axis with respect to said articular surface; and

recording, at a fixed or variable distance from said working axis, the location of a plurality of points along the articular surface with respect to said working axis.

3. A fixation element for an implant for installation into an articular or bony surface, said fixation element comprising:

a surface to engage said fixation element into an articular or bony surface; and

a surface to engage said fixation element into an implant.

4. A fixation element as claimed in claim 3, further comprising a rotational key for radial alignment with respect to said articular surface.

5. A fixation element as claimed in claim 3, wherein said fixation element is a screw.

6. A method for mapping the contours of an articular surface, said method comprising:

establishing a working axis with respect to said articular surface; and

recording, at a fixed or variable distance from said working axis, the location of a plurality of points along the articular surface with respect to said working axis.

7. A method for mapping the contours of an articular surface, said method comprising:

establishing a working axis with respect to said articular surface; and

recording the axial travel of an element contacting said articular surface as said element rotates about said working axis.

8. A method as claimed in claim 7, wherein said recording step is performed by making one or more depressions into a spool coaxial with said working axis, whereby said axial travel of said element is translated to said spool.

9. An implant for installation into an articular surface, said implant comprising:

a bone-contacting or bone-facing surface; and

a surface having a contour substantially matching or based on the contour of said articular surface.

10. A method for determining the minimum thickness for an implant for installation into an articular surface, said method comprising:

assigning a first data point as the maximum value;

comparing said maximum value to other data points; and

reassigning said maximum value for other data points that are greater than the existing maximum value.

11. A method for replacing a portion of an articular surface of bone with an artificial implant, said method comprising:

establishing a working axis with respect to an articular surface of bone;

measuring the location of a plurality of points on said articular surface in relation to said working axis;

removing only a portion of said articular surface, thereby creating an implant site; and

at least one step selected from the group consisting of;

(a) fabricating an artificial implant corresponding to said plurality of points and adapted for installation into said implant site;

(b) selecting from a set of artificial implants an artificial implant corresponding to said plurality of points and adapted for installation into said implant site; and

(c) installing an artificial implant corresponding to said plurality of points and adapted for installation into said implant site.

12. A method as claimed in claim 11, wherein said measuring step and/or said removing step further comprises mating, positioning, or aligning the distal end of a tool with respect to a fixation element or a guide pin or wire having a central longitudinal axis substantially coaxial with said working axis, and rotating at least a portion of said tool about said working axis.

13. A method as claimed in claim 11, further comprising creating one or more depressions into or marks on a recording element, at least one of said depressions or marks corresponding to at least one of said plurality of points.

14. A method as claimed in claim 11, further comprising recording data corresponding to at least one of said plurality of points on an optical, magnetic, or mechanical medium adapted for recording data.

15. A method as claimed in claim 11, further comprising aligning the central longitudinal axis of said artificial implant substantially coaxially with said working axis.

16. A method as claimed in claim 11, further comprising installing into said articular surface a guide pin or wire having a central longitudinal axis substantially coaxial with said working axis.

17. A method as claimed in claim 11, further comprising installing into said implant site a fixation element having a central longitudinal axis substantially coaxial with said working axis.

18. A method as claimed in claim 17, wherein said fixation element comprises a tapered distal feature.

19. A method as claimed in claim 17, wherein said fixation element is adapted to mate, position, or align with an element adapted to aid in the depthwise positioning of said fixation element with respect to said articular surface.

20. A method as claimed in claim 17, further comprising mating, positioning, or aligning said artificial implant with respect to said fixation element.

21. A method as claimed in claim 11, further comprising adjusting said working axis based on at least one of said measured plurality of points.

22. A method as claimed in claim 11, wherein said measuring step further comprises recording the location of said plurality of points by recording the axial travel of an element contacting said articular surface.

23. A method as claimed in claim 22, wherein said recording step further comprises rotating said element about said working axis.

24. A method for replacing a portion of an articular surface of bone with an artificial implant, said method comprising:

fabricating an artificial implant for installation into only a portion of an articular surface of bone, said artificial implant corresponding to a plurality of points measured on said articular surface in relation to a working axis established with respect to said articular surface.

25. A method for replacing a portion of an articular surface of bone with an artificial implant, said method comprising:

selecting, from a set of artificial implants of varying dimensions, an artificial implant for installation into only a portion of an articular surface of bone, said artificial implant corresponding to a plurality of points measured on said articular surface in relation to a working axis established with respect to said articular surface.

26. A method for replacing a portion of an articular surface of bone with an artificial implant, said method comprising:

installing, into only a portion of an articular surface of bone, an artificial implant corresponding to a plurality of points measured on said articular surface in relation to a working axis established with respect to said articular surface.

27. An artificial implant device for installation into a portion of an articular surface of bone, said implant device comprising:

a bone-facing distal surface adapted to mate with an implant site created by excising only a portion of an articular surface of bone; and

a proximal surface having a contour substantially matching or based on the original surface contour of said excised portion of said articular surface.

28. An implant device as claimed in claim 27, further comprising a fixation element having a first contact surface adapted to engage said implant site and a second contact surface to engage said distal surface.

29. An implant device as claimed in claim 28, wherein said fixation element is a screw.

30. An implant device as claimed in claim 28, wherein the first contact surface of said fixation element comprises at least one feature selected from the group comprising:

a thread, a rib, a fin, a milled slot, a tapered distal feature, a feature to prevent rotational movement of said fixation element, and a feature to increase friction at said first contact surface.

31. An implant device as claimed in claim 27, wherein said articular surface of bone is located on a ball portion of said bone, and wherein the depth of said implant site does not extend beyond said ball portion of said bone.

32. An implant device as claimed in claim 27, wherein said articular surface of bone is located on a ball portion of said bone, and wherein said implant device is sized so that no portion of said implant device extends beyond said ball portion of said bone.

33. A device as claimed in claim 27, wherein said artificial implant comprises at least one material from the group consisting of:

ceramic, aluminum oxide, zirconium oxide, metal, metal alloy, Co—

Cr—

W—

Ni, Co—

Cr—

M, CoCr alloy, CoCr Molybdenum alloy, Cr—

Ni—

Mn alloy, powder metal alloy, 316L stainless steel, Ti 6Δ

1-4V ELI, polymer, polyurethane, polyethylene, wear resistant polyethylene, cross-linked polyethylene, thermoplastic elastomer, biomaterial, polycaprolactone, diffusion hardened material, Ti-13-13, Zirconium, Niobium, porous coating system, hydrophilic coating, hydroxyapatite coating, and tri-calcium phosphate.

34. An implant device for installation into an articular surface of bone, said implant device comprising:

a bone-facing distal surface adapted to mate with an implant site created by excising only a portion of an articular surface of bone, said distal surface comprising a fixation element having a contact surface adapted to engage said implant site; and

a proximal surface having a contour substantially matching or based on the original surface contour of said excised portion of said articular surface.

35. A device as claimed in claim 34, wherein said artificial implant comprises at least one material from the group consisting of:

ceramic, aluminum oxide, zirconium oxide, metal, metal alloy, Co—

Cr—

W—

Ni, Co—

Cr—

M, CoCr alloy, CoCr Molybdenum alloy, Cr—

Ni—

Mn alloy, powder metal alloy, 316L stainless steel, Ti 6Δ

1-4V ELI, polymer, polyurethane, polyethylene, wear resistant polyethylene, cross-linked polyethylene, thermoplastic elastomer, biomaterial, polycaprolactone, diffusion hardened material, Ti-13-13, Zirconium, Niobium, porous coating system, hydrophilic coating, hydroxyapatite coating, and tri-calcium phosphate.

36. A fixation element for an implant for installation through an articular surface of bone, said fixation element comprising:

a bone-facing distal surface adapted to mate with an implant site created by excising only a portion of an articular surface of bone, said distal surface comprising a fixation element having a first contact surface adapted to engage said implant site; and

a second contact surface to engage an artificial implant having a corresponding mating element, said artificial implant having a contour substantially matching or based on the original surface contour of said excised portion of said articular surface.

37. A fixation element as claimed in claim 36, wherein said mating element comprises a rotational key component.

38. A fixation element as claimed in claim 36, wherein said mating element is adapted to prevent rotational movement of said implant with respect to said fixation element.

39. A fixation element as claimed in claim 36, wherein said fixation element is a screw.

40. An implant device as claimed in claim 36, wherein the first contact surface of said fixation element comprises at least one feature selected from the group comprising:

a thread, a rib, a fin, a milled slot, a tapered distal feature, a feature to prevent rotational movement of said fixation element, and a feature to increase friction at said first contact surface.

41. A device as claimed in claim 36, wherein said artificial implant comprises at least one material from the group consisting of:

ceramic, aluminum oxide, zirconium oxide, metal, metal alloy, Co—

Cr—

W—

Ni, Co—

Cr—

M, CoCr alloy, CoCr Molybdenum alloy, Cr—

Ni—

Mn alloy, powder metal alloy, 316L stainless steel, Ti 6Δ

1-4V ELI, polymer, polyurethane, polyethylene, wear resistant polyethylene, cross-linked polyethylene, thermoplastic elastomer, biomaterial, polycaprolactone, diffusion hardened material, Ti-13-13, Zirconium, Niobium, porous coating system, hydrophilic coating, hydroxyapatite coating, and tri-calcium phosphate.

42. A device for measuring a portion of an articular surface of bone, said device comprising:

a stationary element having a central axis;

a translating element rotatably and slidably disposed with respect to the central axis of said stationary element;

a traveling element fixedly attached to said translating element and adapted, based on the contours of said articular surface, to travel along a portion of an articular surface of bone both rotatably with respect to the central axis of said stationary element and axially along the central axis of said stationary element or along an axis parallel to the central axis of said stationary element.

43. A device as claimed in claim 42, further comprising a measuring or recording element, wherein said translating element is adapted to translate the axial and rotary travel of said traveling element to said measuring or recording element.

44. A device as claimed in claim 43, wherein said measuring or recording element comprises a spool.

45. A device as claimed in claim 44, wherein said translating element comprises a blade or sharp point for marking at least one depression into the surface of said measuring or recording element.

46. A device as claimed in claim 44, wherein said translating element comprises an ink or stain-based mechanism for marking on the surface of said measuring or recording element.

47. A device as claimed in claim 43, wherein said recording element comprises a digital recording device.

48. A device as claimed in claim 43, further comprising an indexing mechanism in communication with said traveling mechanism, said indexing mechanism facilitating the recording of a predetermined number of points over the course of the revolution of said traveling element.

49. A device as claimed in claim 48, wherein said predetermined number of points is four equally spaced points, at 0, 90, 180, and 270 degrees from origin.

50. A device for preparing a portion of an articular surface of bone to receive an implant, said device comprising:

a shaft having a central axis; and

a blade adapted to rotate about the central axis of said shaft or about an axis parallel to the central axis of said shaft, said blade further adapted to travel along a portion of an articular surface of bone in its rotation and to cut said portion of said articular surface as said blade rotates.

51. A device as claimed in claim 50, wherein the geometry of said blade corresponds to the geometry of an artificial implant to be installed into said articular surface.

52. A device as claimed in claim 50, further comprising a feature adapted to mate with or contact an element having a central longitudinal axis substantially coaxial with said working axis, said element adapted to aid in the depthwise positioning of said blade with respect to said articular surface.

53. A method for depth-positioning an implant with respect to an articular surface of bone, said method comprising:

establishing a working axis with respect to an articular surface of bone;

installing a fixation element into said articular surface, wherein said installed fixation element has a central longitudinal axis substantially coaxial with said working axis, wherein said fixation element is adapted to mate with an extension element adapted to aid in the depthwise positioning of said fixation element with respect to said articular surface; and

mating said fixation element with said extension element.

54. A method as claimed in claim 53, further comprising adjusting the depth of said fixation element until a predetermined point located on said extension element is positioned tangent to the radius that defines said articular surface.

55. A method as claimed in claim 54, further comprising using the relative position of said extension element with respect to said articular surface to define an origin for at least one step selected from the group comprising:

measuring a portion of said articular surface, excising a portion of said articular surface, fabricating an implant, and selecting an implant.

56. A method for replacing a portion of an articular surface of bone, said method comprising:

establishing a working axis with respect to an articular surface of bone;

measuring the location of a plurality of points on said articular surface in relation to said working axis;

removing only a portion of said articular surface, thereby creating an implant site;

at least one step selected from the group consisting of;

(a) fabricating an artificial implant comprising an integrated fixation element, said artificial implant corresponding to said plurality of points and being adapted for installation into said implant site; and

(b) selecting, from a set of artificial implants comprising integrated fixation elements, an artificial implant comprising an integrated fixation element, said artificial implant corresponding to said plurality of points and being adapted for installation into said implant site.

57. A method as claimed in claim 56, further comprising:

aligning said artificial implant with said implant site; and

applying force to said implant in the direction of said site, thereby installing said implant into said site.