WO2010052461A1 - Medical device - Google Patents

Medical device Download PDF

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Publication number
WO2010052461A1
WO2010052461A1 PCT/GB2009/002611 GB2009002611W WO2010052461A1 WO 2010052461 A1 WO2010052461 A1 WO 2010052461A1 GB 2009002611 W GB2009002611 W GB 2009002611W WO 2010052461 A1 WO2010052461 A1 WO 2010052461A1
Authority
WO
WIPO (PCT)
Prior art keywords
head
stem
implant
axis
centre
Prior art date
Application number
PCT/GB2009/002611
Other languages
French (fr)
Inventor
Warwick J. M. Bruce
Original Assignee
T.J. Smith & Nephew Limited
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 T.J. Smith & Nephew Limited filed Critical T.J. Smith & Nephew Limited
Priority to AU2009312593A priority Critical patent/AU2009312593A1/en
Priority to US13/127,400 priority patent/US20120029650A1/en
Priority to EP09760554.7A priority patent/EP2379015B1/en
Publication of WO2010052461A1 publication Critical patent/WO2010052461A1/en

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/32—Joints for the hip
    • A61F2/36—Femoral heads ; Femoral endoprostheses
    • A61F2/3601—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices
    • A61F2/3603—Femoral heads ; Femoral endoprostheses for replacing only the epiphyseal or metaphyseal parts of the femur, e.g. endoprosthetic femoral heads or necks directly fixed to the natural femur by internal fixation devices implanted without ablation of the whole natural femoral head
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61F—FILTERS 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
    • A61F2/00—Filters 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
    • A61F2/02—Prostheses implantable into the body
    • A61F2/30—Joints
    • A61F2/30767—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth
    • A61F2/30771—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves
    • A61F2002/30878—Special external or bone-contacting surface, e.g. coating for improving bone ingrowth applied in original prostheses, e.g. holes or grooves with non-sharp protrusions, for instance contacting the bone for anchoring, e.g. keels, pegs, pins, posts, shanks, stems, struts

Definitions

  • the present invention relates to medical devices, particularly hip implants.
  • Known femoral head resurfacing designs have the stem axis and the femoral head axis concurrent. That is, the stem axis and the femoral head axis are co- linear (see Figure 1A).
  • Femoral anatomy varies significantly between patients. The centre of the femoral neck is often not the centre of the femoral head. Consequently, mismatches can occur when a femoral head is resurfaced with a conventional resurfacing design. Such mismatches mean that known resurfacing designs do not reproduce the natural biomechanics and stability of the joint. This can lead to many problems for the patient, ranging from discomfort to pain and ultimately to failure, necessitating revision surgery.
  • an eccentric resurfacing head there is provided an eccentric resurfacing head.
  • an implant comprising: a head having a central axis; and a stem having a stem axis, wherein the head central axis and the stem axis are not co-linear.
  • an implant for resurfacing a femoral head comprising: a head having a central axis; and a stem having a stem axis, wherein the head central axis and the stem axis are not co- linear.
  • an implant comprising: a head having a bearing surface centre; and a stem having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre.
  • an implant for resurfacing a femoral head comprising: a head having a bearing surface centre; and a stem having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre.
  • a resurfacing femoral head and stem wherein the stem axis is offset compared to the bearing surface centre.
  • an implant comprising a head having a bearing surface and a recess inside the head with a stem, the stem and recess having an axis, wherein the stem/recess axis and the head axis are offset from each other.
  • an implant for resurfacing a femoral head comprising a head having a bearing surface and a recess inside the head with a stem, the stem and recess having an axis, wherein the stem/recess axis and the head axis are offset from each other.
  • an implant comprising: a head having an external surface defining a bearing surface, the bearing surface having a centre, and an internal surface defining a recess within the head; and a stem disposed on the internal surface of the head and having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre.
  • an implant for resurfacing a femoral head comprising: a head having an external surface defining a bearing surface, the bearing surface having a centre, and an internal surface defining a recess within the head; and a stem disposed on the internal surface of the head and having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre.
  • an implant comprising: a head having an external surface defining a bearing surface, the bearing surface having a centre, and an internal surface defining a recess within the head; and a stem disposed on the internal surface of the head and having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre, and wherein the stem and the internal surface are concentric.
  • an implant for resurfacing a femoral head comprising: a head having an external surface defining a bearing surface, the bearing surface having a centre, and an internal surface defining a recess.within the head; and a stem disposed on the internal surface of the head and having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre, and wherein the stem and the internal surface are concentric.
  • the offset between the stem axis and the head bearing surface centre may be any suitable amount.
  • the offset may be an integer or non-integer amount.
  • the offset may be in the range 1-10 mm.
  • the offset may be in the range 1-5 mm.
  • the offset may be in the range 1-3 mm.
  • the offset may be around 1 mm.
  • the offset may be around 2 mm.
  • the offset may be around 3 mm.
  • the internal geometry of the head remains symmetric. This may be achieved by thickening one wall of the head (see Figure 1B). This allows the surgeon to prepare the bone and then decide where to position the centre of the bearing.
  • the stem axis may be parallel, or substantially parallel, to the head centre axis.
  • the stem may be angled. That is, the stem axis may be angled with respect to the head centre axis.
  • the implant may comprise a separable head and stem (i.e. two-part design).
  • the stem may be assembled onto the head in use.
  • the implant is a monobloc/single part comprising a head and a stem.
  • An advantage associated with monobloc embodiments of the present invention is that they are mechanically superior to two-component embodiments.
  • a two component device has fretting interfaces which can lead to wear.
  • a single component device does not have fretting interfaces and is therefore more resistant to wear.
  • Implants according to the present invention may comprise one or more bone ingrowth surfaces.
  • Implants according to the present invention may be made of any suitable material.
  • the implant may comprise metal.
  • the implant may comprise metal alloy.
  • the implant may comprise stainless steel.
  • the implant may comprise titanium.
  • the implant may comprise cobalt chrome.
  • a method of implantation comprising the steps of: providing an implant according to the present invention; and implanting the implant into a body.
  • a method for resurfacing a femoral head comprising the steps of: providing an implant according to the present invention; and implanting the implant with reference to the centre of the femoral neck.
  • An advantage associated with referencing the centre of the neck of the femur is that the risk of neck fracture is minimised or eliminated.
  • the implant may be cemented.
  • the implant may not be cemented.
  • Implants according to the present invention allow the surgeon final control on. the bearing centre of the hip. This is important in restoring the natural biomechanics and stability of the joint.
  • Figures 1A and 1B show cross-sections of a known femoral head resurfacing implant and a femoral head resurfacing implant according to an embodiment of the present invention, respectively;
  • Figures 2A and 2B show a top plan view and a cross-section view of a femoral head resurfacing implant according to another embodiment of the present invention, respectively;
  • Figures 3A and 3B show a top plan view and a cross-section view of a femoral head resurfacing implant according to another embodiment of the present invention, respectively;
  • Figures 4A, 4B and 4C show cross-sections of a known femoral head resurfacing implant, the embodiment shown in Figure 2B and the embodiment shown in Figure 3B, respectively.
  • the femoral head axis (6) and the stem axis (7) are co-linear. That is, the stem (5) is concentric to the head (4) centre.
  • the femoral head axis (6) and the stem axis (7) are offset such that they are not co-linear.
  • implants (1) according to an embodiment of the present invention comprise a stem (5) that is eccentric to the articulating surface (8) but concentric to the internal profile (9).
  • Figures 2A, 2B and 4B show an implant (2) having an offset of approximately 1 mm.
  • Figures 3A, 3B and 4C show an implant (3) having an offset of approximately 2 mm.
  • the embodiment shown in Figure 4A may have a head external diameter of around 50 mm, an offset of 0 mm, and be coupled with a cup having a diameter of around 56 mm.
  • the embodiment shown in Figure 4B may have a head external diameter of around 52 mm, an offset of around 1 mm, and be coupled with a cup having a diameter of around 58 mm.
  • the embodiment shown in Figure 4C may have a head external diameter of around 54 mm, an offset of around 2 mm, and be coupled with a cup having a diameter of around 60 mm.

Landscapes

  • Health & Medical Sciences (AREA)
  • Orthopedic Medicine & Surgery (AREA)
  • Cardiology (AREA)
  • Oral & Maxillofacial Surgery (AREA)
  • Transplantation (AREA)
  • Engineering & Computer Science (AREA)
  • Biomedical Technology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Vascular Medicine (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Prostheses (AREA)

Abstract

An implant, comprising: a head having a central axis; and a stem having a stem axis, wherein the head central axis and the stem axis are not co-linear. A method for resurfacing a femoral head, comprising the steps of: providing an implant according to the present invention; and implanting the implant with reference to the centre of the femoral neck.

Description

Medical Device
The present invention relates to medical devices, particularly hip implants.
Known femoral head resurfacing designs have the stem axis and the femoral head axis concurrent. That is, the stem axis and the femoral head axis are co- linear (see Figure 1A). Femoral anatomy varies significantly between patients. The centre of the femoral neck is often not the centre of the femoral head. Consequently, mismatches can occur when a femoral head is resurfaced with a conventional resurfacing design. Such mismatches mean that known resurfacing designs do not reproduce the natural biomechanics and stability of the joint. This can lead to many problems for the patient, ranging from discomfort to pain and ultimately to failure, necessitating revision surgery.
With known femoral head resurfacing designs there is also little intra-operative flexibility in positioning the centre of the femoral head once the stem has been prepared. Consequently, the mismatches cannot be rectified and the above problems are encountered.
According to an aspect of the present invention, there is provided an eccentric resurfacing head.
According to an aspect of the present invention, there is provided an implant, comprising: a head having a central axis; and a stem having a stem axis, wherein the head central axis and the stem axis are not co-linear.
According to an aspect of the present invention, there is provided an implant for resurfacing a femoral head, comprising: a head having a central axis; and a stem having a stem axis, wherein the head central axis and the stem axis are not co- linear. According to an aspect of the present invention, there is provided an implant, comprising: a head having a bearing surface centre; and a stem having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre.
According to an aspect of the present invention, there is provided an implant for resurfacing a femoral head, comprising: a head having a bearing surface centre; and a stem having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre.
According to an aspect of the present invention, there is provided a resurfacing femoral head and stem, wherein the stem axis is offset compared to the bearing surface centre.
According to an aspect of the present invention, there is provided an implant comprising a head having a bearing surface and a recess inside the head with a stem, the stem and recess having an axis, wherein the stem/recess axis and the head axis are offset from each other.
According to an aspect of the present invention, there is provided an implant for resurfacing a femoral head, comprising a head having a bearing surface and a recess inside the head with a stem, the stem and recess having an axis, wherein the stem/recess axis and the head axis are offset from each other.
According to an aspect of the present invention, there is provided an implant, comprising: a head having an external surface defining a bearing surface, the bearing surface having a centre, and an internal surface defining a recess within the head; and a stem disposed on the internal surface of the head and having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre. According to an aspect of the present invention, there is provided an implant for resurfacing a femoral head, comprising: a head having an external surface defining a bearing surface, the bearing surface having a centre, and an internal surface defining a recess within the head; and a stem disposed on the internal surface of the head and having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre.
According to an aspect of the present invention, there is provided an implant, comprising: a head having an external surface defining a bearing surface, the bearing surface having a centre, and an internal surface defining a recess within the head; and a stem disposed on the internal surface of the head and having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre, and wherein the stem and the internal surface are concentric.
According to an aspect of the present invention, there is provided an implant for resurfacing a femoral head, comprising: a head having an external surface defining a bearing surface, the bearing surface having a centre, and an internal surface defining a recess.within the head; and a stem disposed on the internal surface of the head and having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre, and wherein the stem and the internal surface are concentric.
The offset between the stem axis and the head bearing surface centre may be any suitable amount. The offset may be an integer or non-integer amount. The offset may be in the range 1-10 mm. The offset may be in the range 1-5 mm. The offset may be in the range 1-3 mm. The offset may be around 1 mm. The offset may be around 2 mm. The offset may be around 3 mm.
Preferably, the internal geometry of the head remains symmetric. This may be achieved by thickening one wall of the head (see Figure 1B). This allows the surgeon to prepare the bone and then decide where to position the centre of the bearing.
The stem axis may be parallel, or substantially parallel, to the head centre axis.
The stem may be angled. That is, the stem axis may be angled with respect to the head centre axis.
The implant may comprise a separable head and stem (i.e. two-part design). The stem may be assembled onto the head in use.
Preferably, the implant is a monobloc/single part comprising a head and a stem.
An advantage associated with monobloc embodiments of the present invention is that they are mechanically superior to two-component embodiments. For example, a two component device has fretting interfaces which can lead to wear. In contrast, a single component device does not have fretting interfaces and is therefore more resistant to wear.
Implants according to the present invention may comprise one or more bone ingrowth surfaces.
Implants according to the present invention may be made of any suitable material. The implant may comprise metal. The implant may comprise metal alloy. The implant may comprise stainless steel. The implant may comprise titanium. The implant may comprise cobalt chrome.
According to the present invention, there is provided a method of implantation, comprising the steps of: providing an implant according to the present invention; and implanting the implant into a body. According to the present invention, there is provided a method for resurfacing a femoral head, comprising the steps of: providing an implant according to the present invention; and implanting the implant with reference to the centre of the femoral neck.
An advantage associated with referencing the centre of the neck of the femur is that the risk of neck fracture is minimised or eliminated.
In use, the implant may be cemented.
In use, the implant may not be cemented.
Implants according to the present invention allow the surgeon final control on. the bearing centre of the hip. This is important in restoring the natural biomechanics and stability of the joint.
Reference will now be made, by way of example, to the accompanying drawings, in which:
Figures 1A and 1B show cross-sections of a known femoral head resurfacing implant and a femoral head resurfacing implant according to an embodiment of the present invention, respectively;
Figures 2A and 2B show a top plan view and a cross-section view of a femoral head resurfacing implant according to another embodiment of the present invention, respectively;
Figures 3A and 3B show a top plan view and a cross-section view of a femoral head resurfacing implant according to another embodiment of the present invention, respectively; and
Figures 4A, 4B and 4C show cross-sections of a known femoral head resurfacing implant, the embodiment shown in Figure 2B and the embodiment shown in Figure 3B, respectively. As shown in Figures 1A and 4A, for known femoral head resurfacing implants (10) the femoral head axis (6) and the stem axis (7) are co-linear. That is, the stem (5) is concentric to the head (4) centre. As shown in Figures 1 B, 2A, 2B, 3A, 3B, 4B and 4C, for femoral head resurfacing implants (1-3) in accordance with the present invention, the femoral head axis (6) and the stem axis (7) are offset such that they are not co-linear. As shown in Figure 1B, implants (1) according to an embodiment of the present invention comprise a stem (5) that is eccentric to the articulating surface (8) but concentric to the internal profile (9). Figures 2A, 2B and 4B show an implant (2) having an offset of approximately 1 mm. Figures 3A, 3B and 4C show an implant (3) having an offset of approximately 2 mm.
For example, the embodiment shown in Figure 4A may have a head external diameter of around 50 mm, an offset of 0 mm, and be coupled with a cup having a diameter of around 56 mm. The embodiment shown in Figure 4B may have a head external diameter of around 52 mm, an offset of around 1 mm, and be coupled with a cup having a diameter of around 58 mm. The embodiment shown in Figure 4C may have a head external diameter of around 54 mm, an offset of around 2 mm, and be coupled with a cup having a diameter of around 60 mm.

Claims

Claims
1. An implant, comprising: a head having a central axis; and a stem having a stem axis, wherein the head central axis and the stem axis are not co-linear.
2. An implant, comprising: a head having a bearing surface centre; and a stem having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre.
3. An implant, comprising: a head having an external surface defining a bearing surface, the bearing surface having a centre, and an internal surface defining a recess within the head; and a stem disposed on the internal surface of the head and having a stem axis, wherein the stem axis is offset compared to the head bearing surface centre.
4. An implant according to Claim 3, wherein the stem and the internal surface are concentric.
5. An implant according to any of claims 2 to 4, wherein the offset is in the range 1-3 mm.
6. An implant according to any preceding claim, wherein the implant is for resurfacing a femoral head.
7. An implant according to any preceding claim, wherein the implant is a monobloc.
8. A method of implantation, comprising the steps of: providing an implant according to any of claims 1 to 7; and implanting the implant into a body.
9. A method for resurfacing a femoral head, comprising the steps of: providing an implant according to any of claims 1 to 7; and implanting the implant with reference to the centre of the femoral neck.
10. An implant substantially as hereinbefore described with reference to Figures 1B, 2A, 2B, 3A, 3B, 4B and 4C.
11. A method substantially as hereinbefore described with reference to Figures 1B, 2A, 2B, 3A, 3B, 4B and 4C.
PCT/GB2009/002611 2008-11-05 2009-11-05 Medical device WO2010052461A1 (en)

Priority Applications (3)

Application Number Priority Date Filing Date Title
AU2009312593A AU2009312593A1 (en) 2008-11-05 2009-11-05 Medical device
US13/127,400 US20120029650A1 (en) 2008-11-05 2009-11-05 Medical device
EP09760554.7A EP2379015B1 (en) 2008-11-05 2009-11-05 Medical device

Applications Claiming Priority (2)

Application Number Priority Date Filing Date Title
GB0820233.5 2008-11-05
GBGB0820233.5A GB0820233D0 (en) 2008-11-05 2008-11-05 Medical device

Publications (1)

Publication Number Publication Date
WO2010052461A1 true WO2010052461A1 (en) 2010-05-14

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Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/GB2009/002611 WO2010052461A1 (en) 2008-11-05 2009-11-05 Medical device

Country Status (5)

Country Link
US (1) US20120029650A1 (en)
EP (1) EP2379015B1 (en)
AU (1) AU2009312593A1 (en)
GB (1) GB0820233D0 (en)
WO (1) WO2010052461A1 (en)

Cited By (1)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2585397A (en) * 2019-11-28 2021-01-13 Matortho Ltd Ceramic monobloc femoral component, kit and system comprising the same, and method of manufacture and use thereof

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US9057351B2 (en) * 2012-02-22 2015-06-16 Ford Global Technologies, Llc Method and system for engine control
DE102015212260A1 (en) * 2014-07-09 2016-01-14 Ceramtec Gmbh All-ceramic surface replacement prosthesis with porous inside
CN104887354B (en) 2015-02-10 2017-06-30 江苏奥康尼医疗科技发展有限公司 A kind of combined type high-molecular organic material artificial knee joint
CN105030376B (en) * 2015-02-10 2017-02-01 江苏奥康尼医疗科技发展有限公司 Total hip surface replacement implant
GB2570070B (en) * 2017-11-01 2020-02-26 Matortho Ltd Improvements in or relating to ceramic femoral resurfacing head prosthesis
US20220047394A1 (en) * 2017-11-01 2022-02-17 Matortho Limited Improvements in or relating to ceramic femoral resurfacing head prosthesis

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US4728330A (en) * 1977-01-28 1988-03-01 Comparetto John E Prosthetic bone or tooth implant and a method of surgically implanting the same
US6129764A (en) * 1998-11-24 2000-10-10 Stryker Technologies Corporation Modular prosthetic joint components
EP1285639A2 (en) * 2001-08-23 2003-02-26 Howmedica Osteonics Corp. Modular joint prosthesis with multiple offset head component and method
WO2007026003A1 (en) * 2005-08-31 2007-03-08 Zimmer Gmbh Implant

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US5728161A (en) * 1995-06-08 1998-03-17 Depuy Orthopedics, Inc. Large taper modular shoulder prosthesis
US20030163202A1 (en) * 2002-02-06 2003-08-28 Lakin Ryan C. Modular resurfacing prosthetic
DE102007032583B3 (en) * 2007-07-09 2008-09-18 Eska Implants Gmbh & Co.Kg Set for creating an offset resurfacing hip joint implant

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US4728330A (en) * 1977-01-28 1988-03-01 Comparetto John E Prosthetic bone or tooth implant and a method of surgically implanting the same
US6129764A (en) * 1998-11-24 2000-10-10 Stryker Technologies Corporation Modular prosthetic joint components
EP1285639A2 (en) * 2001-08-23 2003-02-26 Howmedica Osteonics Corp. Modular joint prosthesis with multiple offset head component and method
WO2007026003A1 (en) * 2005-08-31 2007-03-08 Zimmer Gmbh Implant

Cited By (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2585397A (en) * 2019-11-28 2021-01-13 Matortho Ltd Ceramic monobloc femoral component, kit and system comprising the same, and method of manufacture and use thereof
GB2585397B (en) * 2019-11-28 2021-09-01 Matortho Ltd Ceramic monobloc femoral component, kit and system comprising the same, and method of manufacture and use thereof

Also Published As

Publication number Publication date
EP2379015B1 (en) 2020-02-26
GB0820233D0 (en) 2008-12-10
AU2009312593A1 (en) 2010-05-14
US20120029650A1 (en) 2012-02-02
EP2379015A1 (en) 2011-10-26

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