EP3716915A1 - Prothèse de cavité glénoïdale - Google Patents
Prothèse de cavité glénoïdaleInfo
- Publication number
- EP3716915A1 EP3716915A1 EP18801133.2A EP18801133A EP3716915A1 EP 3716915 A1 EP3716915 A1 EP 3716915A1 EP 18801133 A EP18801133 A EP 18801133A EP 3716915 A1 EP3716915 A1 EP 3716915A1
- Authority
- EP
- European Patent Office
- Prior art keywords
- flange member
- separable
- glenoid fossa
- fixation screw
- glenoid
- 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.)
- Withdrawn
Links
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- 210000001991 scapula Anatomy 0.000 claims abstract description 32
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- 238000005553 drilling Methods 0.000 claims description 7
- 230000000087 stabilizing effect Effects 0.000 claims description 6
- 230000015572 biosynthetic process Effects 0.000 claims description 5
- 238000002271 resection Methods 0.000 claims description 4
- 210000001519 tissue Anatomy 0.000 abstract description 26
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- 210000000988 bone and bone Anatomy 0.000 description 12
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- 238000002360 preparation method Methods 0.000 description 4
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- 239000000560 biocompatible material Substances 0.000 description 3
- 210000000845 cartilage Anatomy 0.000 description 3
- 208000008558 Osteophyte Diseases 0.000 description 2
- 206010067268 Post procedural infection Diseases 0.000 description 2
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- RTAQQCXQSZGOHL-UHFFFAOYSA-N Titanium Chemical compound [Ti] RTAQQCXQSZGOHL-UHFFFAOYSA-N 0.000 description 2
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- 230000000771 oncological effect Effects 0.000 description 2
- BASFCYQUMIYNBI-UHFFFAOYSA-N platinum Chemical compound [Pt] BASFCYQUMIYNBI-UHFFFAOYSA-N 0.000 description 2
- 238000011160 research Methods 0.000 description 2
- 210000004872 soft tissue Anatomy 0.000 description 2
- 238000004381 surface treatment Methods 0.000 description 2
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- PCHJSUWPFVWCPO-UHFFFAOYSA-N gold Chemical compound [Au] PCHJSUWPFVWCPO-UHFFFAOYSA-N 0.000 description 1
- 239000010931 gold Substances 0.000 description 1
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- 229910052758 niobium Inorganic materials 0.000 description 1
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- GUCVJGMIXFAOAE-UHFFFAOYSA-N niobium atom Chemical compound [Nb] GUCVJGMIXFAOAE-UHFFFAOYSA-N 0.000 description 1
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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
- A61F2/40—Joints for shoulders
- A61F2/4081—Glenoid components, e.g. cups
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The 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
- A61F2002/30317—The prosthesis having different structural features at different locations within the same prosthesis
- A61F2002/30326—The prosthesis having different structural features at different locations within the same prosthesis differing in height or in length
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The 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
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
- A61F2002/30332—Conically- or frustoconically-shaped protrusion and recess
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The 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
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30331—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit
- A61F2002/30362—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements made by longitudinally pushing a protrusion into a complementarily-shaped recess, e.g. held by friction fit with possibility of relative movement between the protrusion and the recess
- A61F2002/30364—Rotation about the common longitudinal axis
- A61F2002/30367—Rotation about the common longitudinal axis with additional means for preventing said rotation
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The 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
- A61F2002/30329—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
- A61F2002/30433—Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements using additional screws, bolts, dowels, rivets or washers e.g. connecting screws
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The 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
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30574—Special structural features of bone or joint prostheses not otherwise provided for with an integral complete or partial collar or flange
-
- 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
- A61F2002/30001—Additional features of subject-matter classified in A61F2/28, A61F2/30 and subgroups thereof
- A61F2002/30316—The 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
- A61F2002/30535—Special structural features of bone or joint prostheses not otherwise provided for
- A61F2002/30576—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs
- A61F2002/30578—Special structural features of bone or joint prostheses not otherwise provided for with extending fixation tabs having apertures, e.g. for receiving fixation screws
-
- 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
- A61F2/40—Joints for shoulders
- A61F2/4081—Glenoid components, e.g. cups
- A61F2002/4085—Glenoid components, e.g. cups having a convex shape, e.g. hemispherical heads
Definitions
- the present invention relates to endoprosthetic devices and, more specifically, to a scapular endoprosthetic device for full repair of the glenoid in a scapular deficient patient.
- Bone grafts may be utilized, relying on healthy bone (if available) from another area of the patient’s body, donated bone from a cadaver, or synthetic bone in certain situations.
- healthy bone if available
- donated bone from a cadaver
- synthetic bone in certain situations.
- Synthetic bone while reducing the incidence of rejection and post-operative infection, is limited in usefulness as well due to, again, the complexities of the shoulder joint and the physical stresses experienced therein during normal joint operation.
- hemiarthroplasty involves resurfacing of the humeral head joint surface with a cap-like prosthesis of highly polished metal. This is a relatively minimal repair, that relies on the existence of adequate cartilage within the glenoid fossa and a generally otherwise healthy humerus.
- hemiarthroplasty involves a prosthetic humeral head joint surface with an intramedullary stem for fixation within the humeral shaft. This type of repair is often necessitated by severe fractures of the humeral head, but still requires a relatively healthy glenoid with intact cartilage surface.
- Total shoulder replacement involves replacement of the entire glenohumeral joint and is typically necessitated by severe arthritis, physical damage, or disease action resulting in loss of joint cartilage.
- a stemmed hemiarthroplasty repair is mated with a glenoid socket prosthetic component to complete the artificial shoulder joint.
- the glenoid socket component is either cemented or“press-fit” into the bone of the original glenoid fossa.
- the socket and ball components of the repair are reversed, such that the socket portion is fixated on the humeral head and the metal ball portion is fixated in the glenoid fossa.
- fixation plates are malleable to allow the plates to readily conform to the scapular surface, then they are not sufficiently rigid. If the fixation plates are sufficiently rigid, and the gap therebetween is not adequate to straddle the scapula, then the surgeon must force the plates apart or must excise an even greater amount of scapular tissue than desired to complete the repair. Or, if forced onto the scapula, the latent compressive forces in the affixation area can cause post-surgical pain and other problems. If the gap therebetween is far wider than the scapular tissue thickness, then the surgeon must force the plates together during fixation.
- any latent tensile forces resulting from the plates having been drawn together for affixation can, likewise, cause post-surgical pain and other problems. Either scenario exposes the patient’s tissue to unnecessary pressures resulting in increased injury. What is needed is a scapular glenoid fossa replacement device to effect shoulder repair to restore patient function in such instances of scapular deficiency. Further, a need exists for a scapular glenoid fossa prosthesis with sufficiently rigid fixation plates that are modular and have stabilization features that afford fixation without application of unnecessary pressures to the prosthesis components or the patient’s tissue. The present invention satisfies these needs and others as described below.
- a glenoid fossa prosthesis device for repair of a scapular deficient patient comprising: a base member including a rigid fixed flange member affixed thereto, the fixed flange member including therein at least one proximal fixation screw hole for a fixation screw and at least one distal fixation screw hole for a distal fixation screw; the base member further including a first conical taper for receiving a glenoid sphere or a glenoid socket, and a second conical taper for receiving a separable flange member; and a rigid separable flange member including a plurality of fixation screw holes therein, and a conical taper hole for receiving the second conical taper.
- the glenoid fossa prosthesis device fixed flange member further comprises at least one fixation screw hole differs in depth with respect to the other fixation screw holes. In another embodiment, the glenoid fossa prosthesis device fixed flange member further comprises at least one threaded fixation screw hole differs in depth with respect to the other fixation screw holes.
- the glenoid fossa prosthesis is provided wherein the at least one proximal fixation screw is longer than the at least one distal fixation screw.
- the glenoid fossa prosthesis device separable flange member further comprises a locating face for positively engaging the base member to prevent rotation of the separable flange with respect to the base member.
- the glenoid fossa prosthesis device base member further comprises a locating tab feature for positively engaging the separable flange member to prevent rotation of the separable flange with respect to the base member.
- the glenoid fossa prosthesis device fixed flange member or the separable flange member further comprises an inward surface area having a curvature that approximates a surface curvature of a patient’s scapula.
- the glenoid fossa prosthesis device further comprises a thread engagement plate having a length-wise channel formed therein, the channel for receiving the fixed flange member or the separable flange member for engagement therewith, the thread engagement plate including a plurality of holes corresponding to the fixed flange member or separable flange member fixation screw holes.
- the glenoid fossa prosthesis device further comprises a thread engagement plate having a length-wise channel formed therein, the channel for receiving the fixed flange member or the separable flange member for engagement therewith, the thread engagement plate including a plurality of holes corresponding to the fixed flange member or separable flange member fixation screw holes, wherein the thread engagement plate holes are sized to engage the threads of the fixation screws to allow formation of threads within the engaged hole.
- a glenoid fossa prosthesis system for repair of a scapular deficient patient comprising: a glenoid fossa prosthesis device comprising: a base member including a rigid fixed flange member affixed thereto, the fixed flange member including therein at least one proximal fixation screw hole for a fixation screw and at least one distal fixation screw hole for a distal fixation screw; the base member further including a first conical taper for receiving a glenoid sphere or a glenoid socket, and a second conical taper for receiving a separable flange member; and a rigid separable flange member including a plurality of fixation screw holes therein, and a conical taper hole for receiving the second conical taper.
- the glenoid fossa prosthesis system further comprises: a cutting mask device comprising a plurality of stabilizing members for positioning a locator member over a glenoid location of a scapula of a patient, and at least one cutting guide member for guiding a resection tool.
- the glenoid fossa prosthesis system further comprises: a first handled device comprising a pair of handles and opposing jaws, the opposing jaws adapted to engage the fixed flange member and the separable flange member near the base member.
- the glenoid fossa prosthesis system further comprises: a second handled device comprising a conical taper engagement member for positively engaging the first conical taper.
- the glenoid fossa prosthesis system further comprises: a drilling mask device comprising a lengthwise channel for engagement of the separable flange or the fixed flange, and a plurality of drill guide holes that substantially align with the separable flange or the fixed flange when engaged therewith.
- the glenoid fossa prosthesis system wherein the at least one proximal fixation screw is of different length than the at least one distal fixation screw.
- the glenoid fossa prosthesis system separable flange member further comprises a locating face for positively engaging the base member to prevent rotation of the separable flange with respect to the base member.
- the glenoid fossa prosthesis system base member further comprises a locating tab feature for positively engaging the separable flange member to prevent rotation of the separable flange with respect to the base member.
- the glenoid fossa prosthesis system fixed flange member or the separable flange member further comprises an inward surface area having a curvature that approximates a surface curvature of a patient’s scapula.
- the glenoid fossa prosthesis system further comprises a thread engagement plate having a length-wise channel formed therein, the channel for receiving the fixed flange member or the separable flange member for engagement therewith, the thread engagement plate including a plurality of holes corresponding to the fixed flange member or separable flange member fixation screw holes.
- the glenoid fossa prosthesis system further comprises a thread engagement plate having a length-wise channel formed therein, the channel for receiving the fixed flange member or the separable flange member for engagement therewith, the thread engagement plate including a plurality of holes corresponding to the fixed flange member or separable flange member fixation screw holes, wherein the thread engagement plate holes are sized to engage the threads of the fixation screws to allow formation of threads within the engaged hole.
- FIG. 1 is an exploded view of an embodiment of the glenoid fossa prosthesis invention illustrating the modular and stabilizing features thereof;
- FIG. 2 is a depiction of the tools and methods utilized for preparation of a patient’s scapula to accept the embodiment
- FIG. 3 is a depiction of the various sides of the scapula, prepared to accept the embodiment
- FIG. 4 is a depiction of the tools and methods utilized to stabilize the embodiment to the scapula for preparation of the affixation screw holes therein;
- FIG. 5 is a depiction of the tools and methods utilized to affix the embodiment to the prepared scapula
- FIG. 6 is a depiction of the completion of the affixed embodiment by attachment of the glenoid sphere thereto; and
- FIG. 7 is a depiction of the completed scapular repair in a reverse shoulder implant configuration.
- a successful limb-sparing procedure for oncological purposes can be divided into three stages.
- the first stage involves diseased or damaged tissue resection, and must spare adequate tissue structures to support reconstruction while obtaining adequate oncologic margin to eliminate diseased tissue.
- the second stage involves the affixation of a stable, painless skeletal reconstruction (typically an endoprosthetic device).
- Third, the surrounding and supporting soft tissue is required to restore functionality to the skeletal reconstruction.
- the performance of the first two steps of this procedure is well understood, so it is not necessary to provide such detail herein.
- the endoprosthetic device and its use disclosed herein have heretofore never been contemplated.
- the term“scapular deficient patient” means a patient with a scapula effectively lacking a glenoid due to disease or damage.
- the original glenoid structure is severely deficient and, therefore, not viable and/or is completely non-existent due to disease, damage, or genetic deformity and, therefore, traditional shoulder repair techniques are inadequate or unworkable.
- FIGETRE 1 presents an exploded view of an embodiment of the glenoid fossa prosthesis invention illustrating the modular and stabilizing features thereof.
- the glenoid fossa endoprosthetic device (100) includes a base member (102) with a first, primary conical taper (128) and a rigid fixed flange (104) attached thereto, and a rigid separable flange (106) for ease of fitment and affixation of the device to a patient’s scapula in the glenoid deficient area.
- a secondary conical taper (108) acts as a stabilizing and locator member for positively locating the separable flange (106) to the base member (102), while a locating face (124) on the separable flange (106) and locating tab feature (122) on the base prevents rotation of the separable flange with respect to the attachment.
- An M4 screw (110) positively retains the separable flange (106) to the base (102) during affixation of the device (100).
- flange fixation screws (112 and 114) are also utilized to positively retain the device (100) upon implantation. These screws (112 and 114) pass through mounting screw holes (116), through holes drilled in the remaining scapular tissue, and join with the base fixed flange mounting screw holes (118).
- the fixed flange (104) screw holes (118 and 120) include complimentary threads for engaging the fixation screws (114 and 116).
- the screw holes (118 and 120) are not threaded, but are sized such that the fixation screws (114 and 116) actively cut threads therein upon fixation.
- the screw holes (118 and 120) are not threaded, and pass completely through the fixed flange (104).
- a removable thread engagement plate having a length-wise channel formed therein, provides matching screw holes into which the fixation screws (114 and 116) either form threads or engage pre-formed threads for fixation.
- the width of the length-wise channel allows the thread engagement plate to slip over the outer surface of the fixed flange (104) for retention thereon.
- the length-wise channel allows the thread engagement plate to slip over the outer surface of the separable flange (106) for retention thereon, and the fixation screws (114 and 116) are allowed to pass from the fixed flange (104) side through the separable flange (106) and into the attached thread engagement plate.
- a cortical screw (130) is subsequently utilized to complete the fixation of the base (102) to the remaining scapular tissue.
- the first conical taper (128) is provided to position and ultimately support a glenosphere or glenosocket member (not shown).
- the separable flange (106) and the fixed flange (104) differ in thickness as shown to compensate, thereby allowing maximum surface contact for the fixed flange to the resected scapula tissue while maintaining proper base (102) angle with regard to the patient’s original glenoid.
- the flange fixation screws are different lengths to compensate for this differing thickness.
- Two M5 screws of approximately 20mm (112) engage the proximal screw holes (120) in the thinner portion of the fixed flange (104) while two M5 screws of approximately l7mm (114) engage the distal screw holes (118) in the relatively thicker portion of the fixed flange (104).
- the thick/thin portions are reversed as are the screws (112 and 114), for a specific scapular geometry.
- the fixed flange (104) is of even thickness, utilizing screws of same length.
- a titanium trabecular mesh coating (120) is utilized on the inner facing surfaces of the fixed flange (104) and separable flange (106). This porous mesh surface treatment creates a three- dimensional surface structure that is similar to cancellous bone, and which encourages
- the porous mesh surface treatment is created using the known process for creating common trabecular metal, albeit with a greater porosity.
- the surface texture may be created by thermal deposition in which the texture is effectively “printed” onto the surface atom-by-atom.
- Biocompatible materials, including tantalum, may be utilized in this process to create the three-dimensional surface texture structure.
- the base (102) and flanges (104 and 106) are substantially rigid to resist deformation, and formed as part of a machining process.
- the fixed flange (104) is machined separately and otherwise attached to the base member (102) using a common metal bonding process.
- the machined members and all metal components of the embodiment are manufactured from biologically compatible and stable metals.
- the glenosocket joint components comprise CoCrMo alloy, but may be titanium, surgical stainless steel, niobium, gold, platinum, or the like, or some alloyed combination thereof.
- combinations of metals and/or biocompatible polymers and/or coatings may also be utilized and are within the scope of the claimed invention.
- All or a portion of the device (100) may be created through additive manufacturing techniques, for example, using 3D printing technology. For example, it is possible to make a surface scan of the patient’s scapular tissue in the area on which the device (100) is to be affixed. With the surface scan a contour map is generated that is then utilized for printing the final surface contour of the fixed flange (104) and/or the separable flange (106) members.
- FIGURE 2 is a depiction of the tools and methods utilized for preparation of a patient’s scapula to accept the embodiment.
- a cutting mask (202) is pinned to the patient’s scapula (204) as shown, centered over the patient’s glenoid using a k-wire or pin (218) as a locator, passed into the original glenoid location through a locator member (216).
- Stabilizing members (206, 208, and 210) are positioned to further brace the cutting mask to the scapular features.
- An anterior cutting guide member (212) and posterior cutting guide member (214) provide a guide reference for use of resection tools to trim or cut the scapular bone and to cure the bone surface from osteophytes and tissue.
- FIGURE 3 is a depiction of the various sides of the scapula, prepared to accept the embodiment.
- the top image depicts the lateral and anterior faces of the scapula (204), with the anterior cut (302) and lateral cut (304) ready for placement of the base and fixed flange.
- the middle image depicts the lateral and posterior faces of the scapula (204), with the posterior cut (302) for placement of the separable flange member.
- the bottom figure depicts simply the lateral cut (304) for placement of the base member.
- the base member (102) and fixed flange (104) are trial fit against the lateral cut (304) and anterior cut (302) of the scapula (204) and fit is verified. If fit is too tight, additional manual cleaning of the scapular tissue is performed to maximize the tissue contact with the base (102) and flange (104) and ensure proper angle on the base conical taper (126).
- the base (102) can be held by hand in place, with the separable flange (106) conical taper hole installed over the locator conical taper (108) to test fit. Additional manual cleaning of the tissue is performed to maximize the tissue contact with the separable flange (106) and to mate the flange (106) with the base (102).
- FIGURE 4 is a depiction of the tools and methods utilized to stabilize the embodiment to the scapula for preparation of the affixation screw holes therein.
- a first, handled press tool (402) is provided with hinged jaws (404 and 406) that mate with complimentary features on each of the separable flange (106) and fixed flange (104) in the area of the base member (102). Squeezing the press device (402) handles causes the jaws (404 and 406) to move together in a converging direction, thereby compressing the flanges (104 and 106) and to some degree the scapular tissue therebetween.
- a drilling mask device (408) serves as a guide for placement of the drill bit (410) to cut appropriate screw holes in the scapular tissue.
- the drilling mask (408) includes a lengthwise channel for positioning the mask (408) over the separable flange (106) such that the drilling mask holes substantially align with the separable flange (106) fixation screw holes thereunder.
- An appropriately sized drill bit (410) is rotated within each guide hole, where it is advanced until it lightly contacts the fixed flange base mounting screw holes. Once all holes are drilled, the press (402) and drilling mask (408) are removed.
- the drilling mask (408) may be positioned over the fixed flange (104) for formation of the holes as above.
- FIGURE 5 is a depiction of the tools and methods utilized to affix the embodiment to the prepared scapula.
- a second, handled impactor/extractor tool (502) is threaded onto the base (102) glenoid taper (128), where it serves as a handled counter-torque means for the surgeon to stabilize movement of the device as torque is applied to the fixation screws.
- the tool (502) affords a means by which torque caused by tightening (504) of the flange base taper screw (110) may be countered.
- This flange base screw (110) positively affixes the flange (106) to the base (102) member. Subsequently, the flange fixation screws (114 and 116) are installed and torqued as appropriate the torque caused by tightening of the flange fixation screws (112 and 114) may also be countered with the handled tool (502).
- the flange base screw (110) is an M4 surgical grade screw of biocompatible material while the flange fixation screws are M5 surgical grade screws. Other embodiments may utilize similar screws, or a combination thereof.
- the separable flange (106) and fixed flange (104) are likewise curved and of varying thickness to approximate the scapula topography near the glenoid.
- the fixed flange (104) proximal screw holes (120) require placement of a longer screw (114) than the distal screw holes (118), which require a shorter screw (116).
- One benefit of the longer screws (114) near the proximal end is increased thread engagement with the fixed base (104), increasing the strength of the engagement and, therefore, improving the fixation of the device (100) to the scapula (204).
- the separable flange (106) and fixed flange (104) are relatively even thickness and utilize same-sized flange screws (114 and 116). However, this embodiment requires substantially more effort in trimming scapular tissue for the device to achieve a flush fit.
- a thread engagement plate is utilized for engagement with the fixation screws (114 and 116).
- the thread engagement plate length-wise channel is positioned over the outer side of the fixed flange (104), which is the side of the flange opposite that of the scapular tissue.
- the thread engagement plate is positioned along the fixed flange (104) such that the thread engagement plate fixation screw holes align with those in the fixed flange (104), and is engaged therewith.
- the fixation screws (114 and 116) engage the respective engagement plate screw hole threads, or otherwise cut or form threads therein.
- Final fixation of the base is accomplished by installation of a lateral inferior cortical screw (130).
- the cortical screw (130) is approximately 26mm in length or less, so as to not interfere with the proximal flange fixation screws (114). Once the cortical screw (130) is in place and appropriately torqued, the impactor/extractor handled tool (502) can be removed and the joint repair may be completed.
- FIGURE 6 is a depiction of the completion of the affixed embodiment by attachment of the glenoid sphere thereto.
- the glenoid sphere (602) is impacted and installed over the base taper (108).
- the press tool (402) is again utilized to stabilize the affixed device (106) while the glenoid screw (604) is torqued to the appropriate specification (608).
- the glenoid screw (604) is a customized M6 surgical grade screw of biocompatible material.
- FIGURE 7 is a depiction of the completed scapular repair in a reverse shoulder implant configuration.
- the affixed glenoid fossa endoprosthetic device (100) with glenoid sphere (602) serves as a complete replacement for the patient’s diseased or otherwise damaged, glenoid deficient scapula (204).
- the base/fixed flange/separable flange device (100) is solidly rigid on the scapular tissue on which it is attached. Maximum stability of the resulting joint is achieved through this novel approach, which provides maximum fixation strength far in excess of existing repair techniques. While this embodiment presents a reverse shoulder configuration, one of ordinary skill will understand and appreciate that a standard shoulder configuration is also contemplated and is within the scope of the claims herein.
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- 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
Applications Claiming Priority (2)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| US15/829,113 US10485670B2 (en) | 2015-08-14 | 2017-12-01 | Glenoid fossa prosthesis |
| PCT/US2018/057098 WO2019108322A1 (fr) | 2017-12-01 | 2018-10-23 | Prothèse de cavité glénoïdale |
Publications (1)
| Publication Number | Publication Date |
|---|---|
| EP3716915A1 true EP3716915A1 (fr) | 2020-10-07 |
Family
ID=64277822
Family Applications (1)
| Application Number | Title | Priority Date | Filing Date |
|---|---|---|---|
| EP18801133.2A Withdrawn EP3716915A1 (fr) | 2017-12-01 | 2018-10-23 | Prothèse de cavité glénoïdale |
Country Status (2)
| Country | Link |
|---|---|
| EP (1) | EP3716915A1 (fr) |
| WO (1) | WO2019108322A1 (fr) |
Families Citing this family (1)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| CN116509605B (zh) * | 2023-03-21 | 2023-10-24 | 重庆生物智能制造研究院 | 假体植入系统 |
Family Cites Families (5)
| Publication number | Priority date | Publication date | Assignee | Title |
|---|---|---|---|---|
| ITUD20050185A1 (it) * | 2005-11-03 | 2007-05-04 | Lima Lto Spa | Elemento di fissaggio aggiuntivo per una protesi per l' articolazione della spalla |
| US8241365B2 (en) * | 2008-12-23 | 2012-08-14 | Depuy Products, Inc. | Shoulder prosthesis with vault-filling structure having bone-sparing configuration |
| BR112012030045A2 (pt) * | 2010-05-26 | 2016-08-09 | Topsfield Medical Gmbh | próteses implantáveis |
| US9414927B2 (en) * | 2011-12-08 | 2016-08-16 | Imds Llc | Shoulder arthroplasty |
| US9861493B2 (en) * | 2015-08-14 | 2018-01-09 | Gerhard E. Maale | Glenoid fossa prosthesis |
-
2018
- 2018-10-23 EP EP18801133.2A patent/EP3716915A1/fr not_active Withdrawn
- 2018-10-23 WO PCT/US2018/057098 patent/WO2019108322A1/fr not_active Ceased
Also Published As
| Publication number | Publication date |
|---|---|
| WO2019108322A1 (fr) | 2019-06-06 |
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