CA1317702C - Prosthesis with enhanced surface finish - Google Patents

Prosthesis with enhanced surface finish

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Publication number
CA1317702C
CA1317702C CA000557442A CA557442A CA1317702C CA 1317702 C CA1317702 C CA 1317702C CA 000557442 A CA000557442 A CA 000557442A CA 557442 A CA557442 A CA 557442A CA 1317702 C CA1317702 C CA 1317702C
Authority
CA
Canada
Prior art keywords
polymer coating
prosthesis
implant
indentations
base material
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Expired - Lifetime
Application number
CA000557442A
Other languages
French (fr)
Inventor
Roy D. Crowninshield
Arden Rex Zolman
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
Bristol Myers Squibb Co
Original Assignee
Bristol Myers Squibb Co
Priority date (The priority date is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the date listed.)
Filing date
Publication date
Application filed by Bristol Myers Squibb Co filed Critical Bristol Myers Squibb Co
Application granted granted Critical
Publication of CA1317702C publication Critical patent/CA1317702C/en
Anticipated expiration legal-status Critical
Expired - Lifetime legal-status Critical Current

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3662Femoral shafts
    • A61F2/367Proximal or metaphyseal parts of shafts
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2002/30001Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
    • A61F2002/30316The prosthesis having different structural features at different locations within the same prosthesis; Connections between prosthetic parts; Special structural features of bone or joint prostheses not otherwise provided for
    • A61F2002/30317The prosthesis having different structural features at different locations within the same prosthesis
    • A61F2002/30322The prosthesis having different structural features at different locations within the same prosthesis differing in surface structures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30795Blind bores, e.g. of circular cross-section
    • A61F2002/30807Plurality of blind bores
    • A61F2002/30808Plurality of blind bores parallel
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30838Microstructures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/30767Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2002/30906Special external or bone-contacting surface, e.g. coating for improving bone ingrowth shot- sand- or grit-blasted
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3609Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3625Necks
    • A61F2002/3627Necks with lateral apertures, holes or openings
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/32Joints for the hip
    • A61F2/36Femoral heads ; Femoral endoprostheses
    • A61F2/3609Femoral heads or necks; Connections of endoprosthetic heads or necks to endoprosthetic femoral shafts
    • A61F2002/3625Necks
    • A61F2002/3631Necks with an integral complete or partial peripheral collar or bearing shoulder at its base
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2/00Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
    • A61F2/02Prostheses implantable into the body
    • A61F2/30Joints
    • A61F2/46Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor
    • A61F2002/4631Special tools or methods for implanting or extracting artificial joints, accessories, bone grafts or substitutes, or particular adaptations therefor the prosthesis being specially adapted for being cemented
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2250/00Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
    • A61F2250/0014Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis
    • A61F2250/0026Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having different values of a given property or geometrical feature, e.g. mechanical property or material property, at different locations within the same prosthesis differing in surface structures
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61FFILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
    • A61F2310/00Prostheses classified in A61F2/28 or A61F2/30 - A61F2/44 being constructed from or coated with a particular material
    • A61F2310/00005The prosthesis being constructed from a particular material
    • A61F2310/00011Metals or alloys
    • A61F2310/00029Cobalt-based alloys, e.g. Co-Cr alloys or Vitallium

Abstract

ABSTRACT

An orthopaedic prosthesis for implantation with a bone cement composition, the prosthesis including a polymer coating and a textured surface underneath at least a portion of the polymer coating. The textured surface, which is visible to the eye without magnification, beneath the polymer coating enhances or increases the surface shear and tensile strength of the prosthesis.

Description

131770~
PROSTHESIS WITH ENHANCED SURFACE FINISH
BACKGROUNI) OF'IHE INVENTION

The present invention relates to an orthopaedic prosthesis, and more particularly to a prosthesis with an enhanced surface fi-nish for more S secure fLxation.
The precoating of prosthetic implants with a polymer coating is disclosed in U.S. Patent 4,491,987 to Park and in U.S. Patents 4,336,618;
4,365,3S9; 4,281,420; and 4,280,233 to Raab. In addition, U.S. Patent 4,283,799 to Pratt, Jr., et al. ~disclose!; a method of implanting a prosthesis which includes precoating the skeletal cavity and implant stem, allowing both to cure, then applying further cement to the cavity before insertion of the stem. U.S. Patent 4,514,865 to Harris also discloses an embodiment (see Figs. 6 and 7 of Harris) in which an implant stem is precoated with a film of cement.
Numerous types of texturing are known for use on prosthetic implants. The following are representative of such texturing:
U.S. Patent 4,608,053 - Keller U.S. Patent 4,608,052 - Van Kampen, et al.
U.S. Patent 4,549,319 - Meyer U.S. Patent 4,535,487 - Esper, et al.
U.S. Patent 4,530,116 - Frey U.S. Patent 4,430,761 - Nierderer, et al.
U.S. Patent 4,261,063 - Blanquaert IJ.S. Patent 4,199,824 - Nierderer `~' '' ' ' ! I C~
ll 131~70~
' !, U. S . Patent 3,894,297 - Mittelmeier, et al.

! ;! U.s. Patent 2,71~,228 - Van Steenbrugghe European Application EP 0 169 976 Al - Griss ¦ European Application EP O 158 534 A2 - Freeman 1 European Application EP 0 131 178 A2 - Link ~¦ ~uropean Application EP 0 0~5 ~14 Al - Seidel, et al.

¦ Swiss Patent 560,042 - LocKe !
: I Heretofor, prosthetic implants including a precoat of a Ipolymer coating have been incorporated on an untextured surface. While U.S. Patent 4,491,987 describes a pretreatment of the implant surface which i6 to be coated, this pretreatment ! of sulfuric acid, sandblasting, or the like is to prepare a ¦Ifresh ~roughened" surface to improve the bonding between the ¦prosthesis and the polymer coating. However, it is noted that : 15 ,lthi~ ~roughening" of the surface generally does not provide any substantial roughening which is visible to the eye without magnification. Accordingly, the surface is still generally smooth to the eye and doe6 not provide any surface texturing to the implant. ~Precoating of an implant with a polymer coating Iincreases the shear (sliding) strength and increases the tension (pulling) streng~h of an implant over an uncoated implant. In addition, precoating enhances the bond of the precoated implant to bone cement upon implantation with cement, improving the bonding over an uncoated implant.
!.
Texturing for the sake of this specification is defined to be a rough or unsmooth surface which is visible to the eye ;without magnification, often referred to in the art as "macrotexturing." Such texturing of implant surfaces has been widely ~sed as indicated by ~he above-listed patents regaralng Itexturing. Texturing of an implant surface also tends to ¦,increase the shear strength over an untextured implant surace;

I'however. texturing provides only a small increase in tension ¦¦strength .

¦ U.S. Patent 4,566,13~ to Lewi~, et al., is also cited for ; Igeneral information. It includes an implant with a plurality of acrylic spacers adherled to a porous outer surface. The acrylic spacers provide al uniform space between the bone and prosthetic device to uniformly control the thicknes of cement. The acrylic spacers are raised stubs covering only a small portion of the porous surface and such spacers are not a ¦¦coating.
Il Il OBJECTS OF THE INVENTION
I

A principle object of ths invention is to provide an l'orthopaedic prosthesis which includes an enhanced surface finish to strengthen the bond between the prosthesis and the bone cement composition which is used during implantation of the prosthesis.

' Another object of the invention is to provide an orthopaedic implant which provides both increased pull-out (tensile) strength and increased push-out (shear) strength.

!
S~MMARY OF THE INVENTION
i,, The present invention provides an orthopaedic prosthesis ,which includes a polymer coating and a textured surface i,underneath at least a portion of the polymer coating. The (~ f-:) ~ 31~7~2 textured surface preferably includes a plurality of ,indentations in the base material that are readily visible without magnification. The indentations are preferably uniformly spaced and sized in a predetermined pattern with the ~textured surface being substantially confined to within the area of the polymer coating. This orthopaedic implant thus has ,an enhanced surface finish which strengthens the bond between the implant and bone cement which is used during implantation ¦llof the prosthesis.
I
BRIEF DESCRIPTION OF THE DRAWINGS

¦ These features and objects of the invention, as well as others, will become apparent to those skilled in the art by referring to the accompanying drawings:

I Fig. 1 is a perspective view of a hip stem implant according to the present invention;

Fig. 2 is a side elevational view of the hip stem of Fig. 1 shown in partial cross-section;

Fig. 3 is an enlarged partial cross-sectional view taken along lines 3-3 of Fig. 2;
.

Fig. 4 is a cross-sectional view taken along lines 4-4 of Fig. 2, .
Fig. 5 is a cross-sectional view taken along lines 5-5 of Fig. 2, 1~ ' ¦l 1 3 ~ 7 0 2 Fig. 6 is a partial front elevational view of the hip stem;

Fig. 7 is a partial rear elevational view of the hip stem;

Ij ! Fig. B is an enlarged p~rtial side elevational view of the ~textured Sndentations taken at circle B of Fig. 2.

5 I DET~ILED DESC~RIPTION OF THE INVENTION

j¦ Figs. 1-8 illustrate a particularly advantageous eTnbodiment of an orthopaedic implant according to the present invention. The in~ention will be de6cribed with reference to a Ihip pr~sthesis implant; however, it is understood that the l,principles of the invention are applicable to any suitable ¦',prosthetic implant. In addition, the implant of the present i;invention is primarily intended for implantation within a ',warm-blooded mammal with a bone cement composition at the time ,of surgery, although the feature6 of the inven~ion are not limited solely thereto.

The prosthetic hip implant 1 of Fig. 1 includes a head 25 ,and a stem 26. The head 2S may be integrally formed with the stem 26 or it may be a separate component from the stem 26, ',such as is shown in Figs. l and 2. The stem 26 includes a I proximal end 9 and a distal end lO. Generally, the proximal end 9 is considered to be appIoximately the top half portion of the stem 26, and the distal end lO is considered to be approximately the bottom half portion of the stem 26. The stem 26 includes a pair of approximately opposite sidewalls 4 ~separated by a medial side 2 and a lateral side ~.

11 13:17~2 The prosthetic hip implant 1 is comprised of a suitable base material 6tructurally defined as to 6hape and strength to jassimilate a portion of hard mammal tis6ue. In Figs. 1-8, th~
¦Ihip pro6thesi6 1 is formed to replace a portion of the proximal l~human femur. The base ma~erial of the hip prosthesis 1 may be ¦Iformed of any suitably strong material, such as a jcobalt-chromium alloy or other biologically compatible material.

The stem 26 includes a polymer coating 30 about an area of the hip prosthesis for contact with bone cement during ¦ implantation to achieve a chemical bond therebetween. The polymer coating is sub6tantially completely polymerized as a 'coating on the hip prosthesis 1 prior to the implantation.
¦!During implantation of the prosthe6is 1 with fresh bone cement !lat the time of surgery, the polymer coating 30 will become ¦jsecurely bonded to the fresh bone cement as the fresh bone !' cement polymerizes.

The hip prosthesis 1 further includes a textured surface 'l40 over a portion of the base material underneath at least a jportion of the polymer coa~ing 30. The textured surface 30 is Ipreferably confined to within the area of the polymer coating 30. The coating 30 i6 shown in Figs. 1 and 2 to extend from line A to line B as a continuous circumferential coating, thus "completely covering the exposed surface area between lines A
'and B and surrounding the four sides 2. 3, and 4 of the stem 26.

The textured ~urface may include a wide variety of "unsmooth" surface features, such texturing being visible to the eye without magnification. The textured surface 40 referdbly includes a p1urd1ity f indentationd 41 in the basd f !

material that are readily visible to the eye. The indentations 41 are uniformly 6paced and sized in a predetermined pattern.
The indentations 41 or textured surface 40 substantially I'increase the exposed surface area of the base material which is ,to be precoated with the polymer coating. This will increase ~the sarface area of polymer coating which will be in contact with the fresh bone cement in the coated area 30 of the hip prosthesis 1. The indentations 41 of the embodiment shown are each shaped substantially in the form of an inverted pyramid as shown in Fig, 8.

The indentations 41 preferabl~ have a depth "d~ (see ¦~Fig. 3) of approximately o254 millimeters (.010 inches).
However, the indentations may have a minimum depth of about 1l.127 millimeters (.005 inches) and may range to a maximum of labout .762 millimeters (.30 inches). The indentations 41 ¦preferably have a width opening "w" (see Fig. 8) of about .762 millimeters (.030 inches). However, the indentations may have a minimum width opening of about .508 millimeters (.020 inches) and may range to a maximum opening of about 2.032 millimeters ~(.080 inches). The indentations may be suitably arranged ,,uniformly in diagonal rows (see Figs. 1 and 2) with the ro~s preferably being spaced apart by a length "X~ (see Fig. 8) of about .508 millimeters (.020 inches). However, the diagonal 'rows of indentations may be a minimum length apart of about ''.254 millimeters (.010 inches) and may range o a maximum of about 1.524 millimeters (.060 inches).

As shown in Figs. 1 and 2, the polymer coating 30 and the textured surface 40 of the plurality of indentations 41 preferably are substantially in the proximal end 9 of the stem .

Il ~3177~2 ¦ 26 and do not extend into the distal end lO o~ the stem 26.
The polymer coating 30 uniformly and continuously cove~s the l~surface of the pair of sidewalls 4, the medial side 2 and the ''lateral side 3 providing a continuous circumferen~ial coating about the proximal end 9. The textured surace, however, i8 . Ipreferably not included on the medical side 2 or the lateral : Iside 3 but i8 included on ,at least one and preferably both of the pair of sidewalls 4. ThUs, it can be seen that the textured surface 40 is pre:Eerably confined to within ~he area of ~he polymer coating 30, and while the textured surface 40 is underneath at least a portion of the polymer coating 30, it is Inot necessarily included under the whole precoated area.

¦ The sidewalls 4 further include an elongated groove lS
¦extending along the length of the proximal end 9. The groove l15 is untextured and separates the ~extured surface 40 on the sidewalls 4 into a medial textured surface 42 and a lateral textured surface 43. The groove lS extends through at least a majority of the precoated proximal end 9 of the stem 26 and may further extend into the uncoated and untextured distal end lO.

' As shown in Figs. l, 2, 6, and 7, the hip implant may include a collar 13 projecting from the stem 26 just ~elow the ~transition to the neck 20 of the stem 26. In addition, a thru .hole 16 may be provided in the uppermost portion of the '~proximal end 9 (above the precoat boundary line A) to engage a suitable instrument in order to facilitate stem extrac~ion, as ~is known in the art.
, .

j The polymer coating 30 is uniform in thickness about the pr~sthe:is l and is preferably ab~ut 60 microns (.00236 inches) j~ ~ ~ 13~L77~
thick as 6hown by "t~ in Fig. 3. However, the coating 30 may ..have a minimum thickne~ of about 20 micron6 ~.G0079 inches) ~land may range ~o a maxi~um oS abou~ 200 micron~ (.00787 ¦¦inche~). The polymer coating 30 ~ay be applied by any 6uitable ¦,means including the coating methods disclosed in Park (U.S.
491,987) and Raab (4,336,16B; 4.365,359; 4,2Ql,420: and 4,280,233). Accordingly, the pol~mer coating 30 may be a polymethyl methacrylate composition or other suitable polymer composi~ion.

The prosthesifi of the present invention may be manufactured by forming the orthopaedic implan~ in~o a predetermined shape from a suitable base material, such as a ¦¦cobalt-chromium alloy or other ~uitable biologically acceptable material. The implant may b~ formed by forging or other appropriate manu~acturing proce~6es. The de6ired ~hap0 ~ay be .fi~e-tuned by polishing or other ~tandard processes, as ;needed. The textured surface 40 which incl~defi readily visible roughening or indentations ~o the 6urface i~ then applied to the proximal end 9 ~f the sidewalls ~ This can be done by 'pressing the texture on with a die insert on a hydraulic press .or utilizing ot~er suitable manu~acturi~g mean~. The implant i~ then .pr2treated to provide a re~h roughened ~urface in 'preparation for receiving the polymer coating. As previously ;mentioned, the roughened sur~ace that results ~rom the ;pletreatmellt i5 not a readily perceptible roughne~s but is more of a finer roughening of the sur~ace (a micro or fine roughening) which is prepared by 6andblasting. acid etchi~g, or the like. If ~he typical ~roughnes~" of the pretreated implant surface was measured upon magnirica~lon o~ e susI~e, the Il _9_ 7 ~ 2 depth of irregularities in the surace would be minimal, about 15 microns t.00064 inche~) versus the approximate minimum depth of the macro or visible indentations 41 in the textured surface ~40, which was previously noted as about .127 millimeters ~.005 jinches). The polymer coating is then uniformly applied to the proximal end from line A to line B on the sidewalls 4, the medial side 2 and the lat~ral side 3 to provide a continuous circumferential coating about the proximal end 9 and isubstantially completely covering the textured surface 40 on llthe sidewalls 4 with the coating 30. The polymer coating then ¦substantially completely polymerizes on the implant 1.

¦I The resulting implant which includes the textured surPace il40 underneath the polymer precoat 30 provides an increased ,surface area of contact for intimate contact with the fresh ~bone cement at the time of implantation, thus enhancing the bonding of the precoated implant to the new bone cement. The relative magnitude of the impro~ed bonding strength is represented in the following Table 1. Table 1 is representative of tests conducted with cobalt chromium alloy test specimens which have been inserted into fresh cement which is then allowed to polymerize to bond with the test specimens.

; Surface Finish ¦ Pull-out (T0nsile) ¦ Push~out (Shear) of Test S~ecimens I Strennth - PSI I Strenath - PSI
-Standard implant finish 1 781 ¦ 259 ; I I
-Surface Texturing only ¦ 909 1 1303 ~-Polymer coating only 1 1437 1 1328 -Polymer coating, plus 1 1622 1 2029 surface texturing ~ .
1, ~ I --1 0--1'1 . ~

! i ~
I ~3i77~2 It is readily seen that the surface which incorporates the polymer coating 30 plus the macrotexturing 40 significantly ,enhancea the bonding strength of the implant in both tensile Iand shear but especially in shear strength. Thus, the implant ¦~f the present invention has an enhanced surface finish. While ¦~this invention has been described and exemplified, in terms of ¦)a particularly advantageous embodiment those skilled in the art can appreciate that modifications can be made without departiny ~from the spirit and scope oE this invention.

Claims (5)

1. An orthopaedic prosthesis comprising a base material, the prosthesis having a polymer coating about an area of the prosthesis the coating being substantially completely polymerized, and the prosthesis further including a textured surface over a portion of the base material underneath at least a portion of the polymer coating, wherein the textured surface is a macrotextured surface which includes a plurality of indentations in the base material that are readily visible without magnification and wherein the polymer coating is uniform in thickness about the prosthesis, thus providing an indented, nonsmooth polymer surface wherein the polymer coating does not completely fill up the indentations, but wherein the polymer surface has indentations therein.
2. The prosthesis of claim 1 wherein the base material includes a stem having a proximal end and a distal end and a pair of sidewalls interconnected by a medial side and a lateral side, and wherein the textured surface is confined substantially to within the area of the polymer coating.
3. The prosthesis of claim 2 wherein the polymer coating and plurality of indentations are substantially in the proximal end of the stem and do not extend into the distal end of the stem.
4. The prosthesis of claim 3 wherein the polymer coating in the proximal end uniformly and continuously covers the surface of the pair of sidewalls and the medial and lateral sides while the textured surface is not included on the medial and lateral sides but is included on at least one of the pair of sidewalls.
5. A method of manufacturing an orthopaedic implant including the following steps:
a. forming the orthopaedic implant into a predetermined shape from a suitable base material;
b. applying a macrotextured surface on a portion of the implant surface in which the macrotextured surface includes a plurality of indentations in the base material which are readily visible without magnificarion;
c. pretreating the implant surface to provide a fresh, roughened surface in preparation for receiving a polymer coating;
d. applying a polymer coating to the prepared pretreated surface such that the textured surface is underneath at least a portion of the polymer coating and substantially confining the macrotextured surface to within the area of the polymer coating: and e. permitting the polymer coating to substantially completely polymerize on the implant.
CA000557442A 1987-01-28 1988-01-27 Prosthesis with enhanced surface finish Expired - Lifetime CA1317702C (en)

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US07/007,538 US4795472A (en) 1987-01-28 1987-01-28 Prosthesis with enhanced surface finish

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