US011596520B2
`
`a2) United States Patent
`US 11,596,520 B2
`(0) Patent No.:
`Mar.7, 2023
`(45) Date of Patent:
`Perego etal.
`
`(54) PERFECTED TOTAL SHOULDER
`PROSTHESIS
`
`(71) Applicant: Permedica S.p.A., Merate (IT)
`
`2002/4051; A61F 2002/4062; A61F
`2002/4081; A61F 2002/4085; A61F
`2002/30616; A61F 2002/30784; A61F
`2002/3093
`See application file for complete search history.
`
`(72)
`
`Inventors: Marco Perego, Merate (IT); Federico
`Perego, Merate (IT); Hans Rudolf Paul
`Bloch, Dino (CH)
`
`(56)
`
`References Cited
`U.S. PATENT DOCUMENTS
`
`(*) Notice:
`
`Subject to any disclaimer, the term ofthis
`patent is extended or adjusted under 35
`U.S.C. 154(b) by 142 days.
`
`(21) Appl. No.:
`
` 16/640,481
`
`(22) PCT Filed:
`
`Sep. 10, 2018
`
`(86) PCT No.:
`
`PCT/IB2018/056880
`
`§ 371 (€)(),
`(2) Date:
`
`Feb. 20, 2020
`
`(87) PCT Pub. No.: WO2019/053576
`
`PCT Pub. Date: Mar. 21, 2019
`
`(65)
`
`Prior Publication Data
`
`US 2020/0214846 Al
`
`Jul. 9, 2020
`
`(51)
`
`(2006.01)
`(2006.01)
`
`Int. Cl.
`AGIF 2/40
`AOIF 2/30
`(52) U.S. Cl.
`CPC we AGIF 2/4014 (2013.01), A6LF 2/4081
`(2013.01); AOLF 2002/3093 (2013.01); AGLF
`2002/30604 (2013.01); A6LF 2002/30616
`(2013.01); A6IF 2002/30784 (2013.01); AGIF
`2002/4051 (2013.01); A6LF 2002/4062
`(2013.01); AOLF 2002/4085 (2013.01); AGLF
`2310/00023 (2013.01); AGLF 2310/00179
`(2013.01); AIF 2310/00407 (2013.01)
`(58) Field of Classification Search
`CPC .... A61F 2/4014; A61F 2/4081; A61F 2/4059;
`A61F 2002/4011; A61F 2002/4018; A61F
`2002/4037; A61F 2002/4044; A61F
`
`2006/0200249 Al*
`
`2011/0029089 A1*
`
`2005/0049709 Al
`2005/0177241 Al*
`
`3/2005 Tornier
`8/2005 Angibaud ............ A6I1F 2/4014
`623/19.14
`9/2006 Beguin .... A6I1F 2/4014
`623/19.14
`2/2011 Giuliani oo. A61F 2/40
`623/19.14
`2012/0253467 Al* 10/2012 Frankie 0... A6I1F 2/4014
`623/19.11
`2013/0325133 AL* 12/2013 Viscardi 0... A61F 2/4003
`623/19.14
`
`FOREIGN PATENT DOCUMENTS
`
`WO
`WO
`
`2007109800
`2008015724
`
`9/2007
`2/2008
`
`* cited by examiner
`
`Primary Examiner — Christopher D. Prone
`(74) Attorney, Agent, or Firm — Themis Law
`
`ABSTRACT
`(57)
`A shoulder prosthesis includes a humeral portion and a
`scapular portion, each having an osseointegrable component
`and an articular component. The osseointegrable component
`in the humeral portion includes a humeral body produced as
`a semicircular asymmetrical cage having a proximalcircular
`ring base facing the scapular portion and an eccentric distal
`cylindrical base in opposite position, which are connected
`by arms having one or more holes for favoring the growth
`of bone tissue and facilitating anchorage to the bone, the
`proximal circular ring base being configured to be inter-
`changeably coupled with the articular component for an
`anatomical prosthesis or a concave insert for a reverse
`prosthesis. The osseointegrable component in the scapular
`portion includes a glenoid base-plate of asymmetric form for
`coupling to an articular component, such as a concave
`glenoid insert, for an anatomical prosthesis or a glenosphere
`for a reverse prosthesis.
`
`15 Claims, 16 Drawing Sheets
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`Sheet 1 of 16
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`SCAPULAR PORTION
`
`ee~ HUMERAL PORTION
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`US 11,596,520 B2
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`US 11,596,520 B2
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` POMONA
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`ONOONECONECOECONECEHOEE
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`oe,
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`132
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`Fig. 4
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`Fig. 7c
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`Fig. 8b
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`Fig. 10a
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`Fig. 10b
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`12
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`130-3.5
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`140-0
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`140-3.5
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`165
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` 16l Fig. 17¢
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`Fig. 18
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` =
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`0,968
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`0.950
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`0.935
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`More circular
`More elongated
`elliptic base
`elliptic base
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`Fig. 19
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`ANTERIOR-POSTERIOR DIRECTION
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`ORTHOGONAL PLANES
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`INFERIOR-SUPERIOR DIRECTION
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`Fig. 20
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`US 11,596,520 B2
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`1
`PERFECTED TOTAL SHOULDER
`PROSTHESIS
`
`The present inventionrelates to a perfected total anatomi-
`cal and reverse shoulder prosthesis.
`Asis well known to skilled personsin the field, shoulder
`arthroplasty is a reliable procedure for the treatment of
`severe pathologies of the glenohumeraljoint for eliminating
`pain and restoring the functionality of the shoulder.
`Articular prosthesis refers to an implantable device,
`including the implantable subsidiary components and mate-
`rials, designed for exerting functions similar to those of a
`natural joint and which is put in connection with the corre-
`sponding bones.
`Traditional shoulder prostheses with a humeral stem are
`commonly used in clinical practice.
`The first shoulder prostheses were designed for treating
`cases of fractures of the humerus,
`for this reason the
`presence of the prosthetic humeral stem was therefore
`mandatory.
`There are, however, frequent complications associated
`with the use of humeral stems. These complications include
`bone loss from the humerus,
`intra- and post-operative
`periprosthetic fractures, malpositioning of the humeral com-
`ponent, difficulty in treating deep infections involving the
`medullary cavity of the humerus and high intraoperative
`blood loss due to the opening of the medullary canal.
`The most demanding part of the procedure is the ana-
`tomical reconstruction of the proximal humerus, especially
`in cases of post-traumatic malunion or in the case of
`dysplasia. Only a good reconstruction of the proximal
`humerusthat respects the anatomy, allows goodresults to be
`obtained in terms of prosthetic stability, good articulation
`and longevity of the implant.
`Intraoperative fractures of the humerusare often caused
`by excessively forced shoulder maneuvers, excessive mill-
`ing of the medullary canal and incorrect insertion of the
`uncemented stem into the diaphysis. The result is often a
`long spiral fracture. The reported incidence of this compli-
`cation is around 1.5%. A malpositioning of the humeral stem
`can in turn lead to a malpositioning of the humeral head.
`Modular prosthetic designs of the humeral component
`have considerably improved the anatomical adaptability to
`the individual anatomy of the proximal humerus,in particu-
`lar also especially in post-traumatic cases with severe defor-
`mity of the diaphyseal axis; a perfect anatomical reconstruc-
`tion, however, is not always possible.
`Postoperative complications relating to the humeral com-
`ponent mainly include fractures, especially in elderly
`patients with osteoporotic bone (between 1% and 3%) and
`mobilization of the stem (up to 5%).
`Another potential risk is the removal of the stem in the
`event of a surgical revision. A vertical osteotomy is often
`necessary, particularly with uncemented stems or when a
`large layer of cement is present. This surgical procedure is
`associated with high morbidity, and the anchoring of a new
`prosthetic stem in the case of significant boneloss is difficult
`and often requires the use of a long revision stem.
`The resurfacing of the humeral head was created to
`restore the normal anatomy of the shoulder with a minimal
`resection of the bone eliminating the complications relating
`to the stem and maintaining the “bone stock”for facilitating
`any possible future conversion revisions into a total con-
`ventional shoulder prosthesis.
`also shown
`Resurfacing arthroplasty, however, has
`numerous limitations. It is not suitable, in fact, in cases of
`
`10
`
`15
`
`25
`
`35
`
`40
`
`45
`
`55
`
`65
`
`2
`severe deformity of the proximal humerus, post-traumatic
`malunion or extensive necrosis for more than 35% of the
`humeral head.
`
`It can be associated with a varus/valgus malpositioning of
`the humeral component, with a consequent increased wear
`of the glenoid, and can generate excessive tensioning in the
`soft tissues, with a consequent increase in muscle tension
`and a reduction in the “range of motion”.
`Furthermore, the exposure of the glenoidis difficult when
`the humeral head remainsin situ, thus requiring an extensive
`peripheral release of the soft parts.
`Pursuing the objective of reducing the complications
`relating to the stem and eliminating the mobilization of the
`humeral component while maintaining the advantages of a
`third generation of shoulder prostheses, in 2004 a group of
`French surgeons introducedthe first stemless humeral pros-
`thesis (TESS®, Biomet Inc., Warsaw, Ind.).
`The aim of a stemless humeral prosthesis is to reconstruct
`the anatomy of the humeral head without the need for using
`a stem, with an automatic centering, through a simple and
`reproducible surgical technique, maintaining the bone stock
`of the humerusand,at the same time, allowing an adequate
`exposure of the glenoid.
`Numerous recent studies have shown excellent results
`
`following the use of this stemless prosthesis, also comparing
`them directly with traditional stemmed prostheses.
`The decision to resort to a prosthetic glenoid replacement
`remains debatable. This uncertainty is based on the potential
`negative effects of glenoid wear with the partial shoulder
`prosthesis that contrasts with the risks relating to the mobi-
`lization and failure of a glenoid prosthetic component.
`Improvedclinical results, however, in termsof pain relief
`and joint functionality are proven with the use of total
`shoulder replacement compared to the use of endoprosthe-
`sis. Patients with arthritis treated with endoprosthesis often
`remain symptomatic even in the long term.
`In general,
`the long-term mobilization of the glenoid
`componentdoes not appear to be an indication in favour of
`endoprosthesis comparedto total arthroplasty. Furthermore,
`another aspect to the detriment of endoprosthesis is that a
`revision for converting an endoprosthesis to a total arthro-
`plasty can be made difficult by the erosion of the glenoid.
`In shoulder arthroplasty, the choice of the correct pros-
`thetic device is effected in certain cases during surgery.It is
`therefore preferable to use a prosthetic system that provides
`the surgeon with the possibility of an intraoperative choice
`of different prosthetic configurations (stemmed, stemless,
`anatomic, reverse), depending on the anatomyofthe proxi-
`mal humerus, the quality of the bone, the state of the glenoid
`and the state of the rotator cuff.
`
`Even with careful preoperative planning with bone den-
`sitometry tests, it is possible to find intraoperatively a bone
`quality not corresponding to that evaluated preoperatively,
`so that the possibility must be provided of intraoperatively
`changing from a stemless system to a stemmed system.
`As the stemless humeral component (called “core” in
`technical jargon) is implanted in the metaphyseal bone with
`the anatomical CCD angle of the patient, the fixing of the
`humeral stem must absolutely consider the offset.
`Different sizes of the core, together with an asymmetrical
`arrangement of the anchorage branches in the metaphyseal
`bone, are basic for an uncemented stemless humeral com-
`ponent. In the case of immediate conversion from a stemless
`to stemmed implant during surgery, different offsets can
`guarantee a correct coupling between the core and the stem
`without modifying the joint geometry but re-establishing the
`articular parameters planned before surgery.
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`3
`The prosthesis according to the present invention has been
`conceived and developed maintaining the concept of modu-
`larity on the glenoid side and on the humeral side in order
`to provide solutions for a wide spectrum of indications for
`shoulder arthroplasty.
`This prosthesis allows a total anatomical shoulderarthro-
`plasty to be performed andto convert it to reverse using the
`same stemless humeral core that does not need to be
`
`replaced if it is stable and osseointegrated in the case of
`revision.
`
`10
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`15
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`20
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`25
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`30
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`35
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`40
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`45
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`55
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`The aseptic loosening of the glenoid componentis still the
`most common complication in total anatomical shoulder
`arthroplasty. The overall incidence of glenoid mobilization
`reaches up to 14% in total shoulder arthroplasty.
`The mobilization of the glenoid componentin the total
`prosthesis is a phenomenon consideredas beingthe result of
`multiple factors, among which an eccentric load (caused by
`a deficiency or failure of the rotator cuff or other instability
`of the soft tissues), polyethylene wear osteolysis, an inad-
`equate cementation technique, malpositioning of the implant
`or over-stuffing of the joint.
`Shoulder prostheses of the known type are described, for
`example,
`in patents: WO2007/109800, FR 2652498, EP
`1787603, WO 2015/001525A1 which corresponds
`to
`1T1418610.
`
`On page 2 of WO2015/001525A1 the following can be
`read:
`
`“Starting from this known technique, the objective of the
`present invention is to provide a prosthesis for reconstruct-
`ing the shoulder joint which is alternative to those known,
`particularly efficient and capable of achieving the following
`results:
`
`Reducing the risks of detachment at the glenoid;
`Eliminating faults or breakages of the front portion of the
`glenoid joint; and
`Facilitating the transition from the anatomical configura-
`tion to the reverse configuration.
`In general,
`the present
`invention achieves the results
`indicated above by inverting, in an absolutely innovative
`mannerand contradicting the standard currently known, the
`tribological characteristics of the coupling at the base of the
`prosthesis for the reconstruction of the shoulderjoint.
`In particular, it is provided that the front portion of the
`glenoid joint be made of a metallic material and the corre-
`sponding portion of the humerusis in plastic material.
`The fixing portions to both the glenoid and the humerus
`are made of a metal material of the “cementless” type, i.e.
`fixed in place by means of threaded elements, and are
`configured to removably receive the relative articulation
`portions. In this way,
`it
`is much easier to pass from an
`anatomical configuration to a reverse configuration.”
`(Italian translation from IT1418610)
`This objective is achieved by producing a shoulder pros-
`thesis comprising:
`a glenoid prosthesis comprising a fixing support to the
`glenoid and a glenoid articulation element;
`a humeral prosthesis comprising a fixing support to the
`humerus andan articulation element of the humerus.
`
`Said articulation elements of the glenoid and humerusare
`shaped so as to create a spherical-type coupling for the
`artificial reconstruction of the shoulder joint, the glenoid
`articulation element having a concave surface andthe ele-
`ment of articulation of the humerus being hemispherical-
`shaped.
`
`4
`The articulation element of the humerus is made of a
`
`plastic material (polyethylene) whereasthe articulation ele-
`ment of the glenoid is made of a metallic material (cobalt-
`chromium alloy).
`A shoulder prosthesis produced in this way does not
`guarantee a lasting integration of the prosthesis to the bone
`structure of the shoulder, in particular to the humerus.
`Furthermore, the spherical coupling between the articu-
`lation elements leads to considerable wear osteolysis of the
`polyethylene.
`An anatomical prosthesis is also described in patent
`US2005/0049709 wherein the glenoidal component com-
`prises a metal body whoseinnersurface is suitable for being
`immobilized in the glenoid cavity of the shoulder and the
`outer surface has a concave articulation surface suitable for
`
`cooperating with the humeral component.
`The humeral component 4 comprises a stem anchored to
`the medullary cavity and a hemispherical head which, at
`least
`in its peripheral part,
`is made of polyethylene,
`in
`particular high-density polyethylene (HDPE).
`US patent 2012/0253467 describes both an anatomic
`prosthesis and a reverse prosthesis.
`The glenoid component 300 (700 in the reverse prosthe-
`sis)
`is made of ceramic, metal or other biocompatible
`material whereas the humeral component 500 (800 in the
`reverse prosthesis) is made of ceramic, polyethylene or
`another biocompatible material.
`The documentalso describes a prosthesis provided with a
`stem and doesnot describe components of the prosthesis that
`can be used for implanting prostheses with or without a
`stem, depending on the patient’s needs.
`The document WO 2007/109800 describes a reverse
`
`shoulder prosthesis that can be transformedinto an anatomi-
`cal prosthesis leaving the stem inserted in the bone. The
`document does not describe a stemless prosthesis.
`The document WO 2008/015724 describes a modular
`
`shoulder prosthesis provided with a stem suitable for passing
`from direct to a reverse configuration.
`The prosthesis body 16 comprises supporting flaps 40
`which define an angle with each other so as to receive in
`abutment the tuberosities of the humerus 20.
`
`The supporting flaps 40 have holes 44 to allow the
`passage of a thread for the re-sewing of the tuberosities 20.
`An engagementportion in the form of a cup suitable for
`interacting with a glenosphere associated with a correspond-
`ing glenoid, is associated with the prosthetic body, with a
`coupling of the male female type.
`As shown in FIG. 35, the component 16 engagesdirectly
`on the stem inserted in the humerus.
`The objective of the present invention is to overcomethe
`above-mentioned drawbacks, and those of the knownart in
`general, by producing a total shoulder prosthesis capable of
`combining the advantages of the knownart and a: the same
`time eliminating the drawbacks.
`this objective is
`According to the present
`invention,
`achieved by producing a shoulder prosthesis having the
`characteristics set forth in claim 1 and the sub-claims.
`
`According to the present invention, the modular system
`claimed with a humeral body having a surfaceat least partly
`trabecular, as described hereunder, allows a rapid and easy
`passage from a stemless prosthesis to a stemmedprosthesis
`and from an anatomical prosthesis to a reverse prosthesis.
`The trabecular surface allows an excellent and high bone
`re-growth inside the pores and a fast osseointegration of the
`components for an optimal secondary stability.
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`5
`Thetrabecular structure of the surfaces of the components
`object of the present invention, has a high friction coefficient
`with the bone for allowing a high initial press-fit of the
`implant.
`The characteristic asymmetric pear shape of the anatomi-
`cal glenoid insert of the present invention allows an optimal
`articular surface to be obtained.
`
`According to the present invention, the combination of
`the inversion of the materials of the modular articular
`
`components with the non-spherical geometry of the pros-
`thetic humeral head improves the prosthetic stability and
`decreases the wear of the polyethylene in the anatomical
`prosthesis.
`As metal implants can be produced with thinner thick-
`nesses with respect to polyethylene components, the risk of
`over-stuffing the reconstruction of the glenohumeral joint in
`total anatomical arthroplasty is considerably reduced by
`using a metal-back (basalplate or base-plate) with trabecular
`titanium for anchorage with the glenoid bone and covered
`with a thin metalinsert.
`
`According to the present invention, in the case of the need
`to convert from a total anatomical prosthesis to a total
`reverse prosthesis, the metallic glenoid insert can be disas-
`sembled from the metal-back, leaving the metal-back (basal
`plate or base-plate) in situ and substituting the insert with a
`polyethylene glenosphere. On the humeral side, in the case
`of conversion from anatomical
`to reverse,
`the humeral
`polyethylene head can be replaced by a metal reverse
`prosthetic insert, available in different thicknesses.
`Anatomical glenoid implants with an uncemented metal-
`back as produced accordingto the present invention have the
`advantage of a simpler surgical revision in the case of
`conversion into a reverse prosthesis due to a failure of the
`cuff, as the metal back can beleft, if stable and osseointe-
`grated, replacing only the polyethylene insert.
`The longevity of metal-back implants can be increased by
`improving the mechanical anchorage of the metal-back with
`the glenoid bone in the anatomical prosthesis, thus respect-
`ing the radius of anterior-posterior and superior-inferior
`curvature of the glenoid.
`The current use of an imperfect radial coupling of the
`spherical humeralheadin orderto allow a translation motion
`is a compromise that reduces the contact area with the
`glenoid component which can cause polyethylene wear,
`joint instability and prevents correct articular kinematics.
`The use of a non-spherical humeral head,
`in articular
`coupling with a two-radius curvature glenoid surface,
`reduces polyethylene wear in the glenoid and improvesjoint
`stability by better reproducing the physiological kinematics
`between the head of the humerus and the scapular glenoid.
`Anon-spherical elliptical prosthetic head replicates more
`accurately the anatomical shape of the patient’s humeral
`head, the range of motion in rotation, the kinematics of the
`glenohumeral joint compared to the models of spherical
`prosthetic heads available on the market.
`A biomechanical study has shown that a non-spherical
`humeral prosthetic head increases the stability of the gle-
`nohumeral joint.
`According to the present invention,the elliptical shape of
`the base of the humeral head extends with an increasing size
`of the anatomical humeral head.
`
`The most common complication in total reverse shoulder
`prosthesis is the scapular notching, osteolysis of the lower
`lateral edge of the scapula caused by the conflict between the
`scapula and the polyethylene humeral insert. In addition to
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`being associated with a greater risk of mobilization of the
`glenoid component, scapular notching is also associated
`with inferior clinical results.
`
`According to the present invention, in order to avoid wear
`from scapular impingement of the humeral insert, a metal
`humeral insert is provided, articulated against a polyethyl-
`ene glenosphere.
`In the case of conversion from stemless to stemmed
`
`prostheses, such as, for example, in cases of trauma after
`total anatomical or
`reverse prosthesis,
`a metaphyseal
`humeral componentwith variable offsets gives the possibil-
`ity of connecting a well-osseointegrated humeral core to a
`humeral stem having a variable length, from short to long up
`to 215 mm for revision cases.
`
`The prosthesis object of the present invention combines
`all the advantages of a stemless prosthetic system ofa first
`implant with the possibility of broadening the indications to
`a procedure that requires the use of a humeral stem with an
`easy conversion from anatomical prosthesis to reverse, using
`a single prosthetic system and without having to replace the
`osseointegrable components but only the modular articular
`components.
`Thestructural and functional characteristics of the inven-
`
`tion, and its advantages with respect to the knownart, can be
`clearly understood from the following description, referring
`to the attached drawings, which illustrate non-limiting
`embodiment examples of the invention itself.
`In the drawings:
`FIG.
`1
`is an exploded perspective view illustrating the
`total shoulder prosthesis system made according to the
`invention;
`FIG.2 is a raised view of the prosthesis of FIG. 1 in the
`stemmed anatomical configuration;
`FIG. 3 is a view similar to FIG. 2, but showing the
`prosthesis in the reverse configuration;
`FIG.4 is an overall view of the prosthesis according to the
`invention, but in the stemless anatomical configuration;
`FIGS. 5a, 5b, 5c are sections of the prosthesis of FIG.4;
`FIG.6 is an overall view of the prosthesis accordingto the
`invention, but in the stemless reverse configuration;
`FIGS. 7a, 7b, 7c are sections of the prosthesis of FIG. 6;
`FIG. 7d is a section showing the glenoid component with
`glenosphere, a short safety screw, adapter, central fixing
`screw and lower and upperfixing screws;
`FIG. 8a is an anterior-posterior section of the glenoid
`insert;
`FIG. 8b is an upper-lower section of the glenoid insert;
`FIG. 9a is a front view of the glenoid base-plate;
`FIG. 9b is a front view of the concave glenoid insert;
`FIGS. 10a and 10billustrate the trabecular surface of the
`humeral body;
`FIG. 11 illustrates an embodiment of the humeral body
`having a trabecular surface on arms, ring base and distal
`base;
`FIG. 12 illustrates various components of the prosthesis
`object of the present invention with a trabecular surface;
`FIG.13 illustrates the position of the arms of the humeral
`body;
`FIG. 14 illustrates metaphyseal humeral connectors with
`various offsets and various CCDtilt angles;
`FIGS. 15a and 15billustrate a front and rear view (i.e. that
`positioned in contact with the bone in a mounted condition
`of the prosthesis on the glenoid) of the glenoid base-plate
`with a trabecular structure;
`FIGS. 16a and 16billustrate a front and rear view (i.e. that
`positioned in contact with the base-plate in a mounted
`
`CATALYST, EX-1010
`PAGE20
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`CATALYST, EX-1010
`PAGE 20
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`US 11,596,520 B2
`
`7
`condition of the prosthesis on the glenoid) of the anatomical
`glenoid insert with the characteristic form object of the
`present invention;
`FIGS. 17a-17c illustrate the anterior-posterior radius
`RA-P (transverse plane) and the inferior-superior radius
`RI-S (coronal plane) of the anatomical glenoid insert;
`FIG. 18 illustrates the anatomical humeral head with an
`
`ellipsoidal geometry;
`FIG.19 illustrates the ratio between the anterior-posterior
`diameter and the inferior-posterior diameter of the anatomi-
`cal humeral head in the various sizes;
`FIG. 20 is a schematic perspective view illustrating the
`total shoulder prosthesis of the invention implanted in the
`human body.
`The prosthesis according to the present invention allows,
`thanks to its modularity:
`an anatomical configuration (FIG. 2, FIG. 4, FIGS. 5a, 5b,
`5c) and a reverse configuration (FIG.3, FIG. 6, FIGS. 7a, 7b,
`Te);
`a stemless configuration (FIG. 4, FIGS. 5a, 5b, 5c, FIG.
`6, FIGS. 7a, 7b, 7c) and a stemmed configuration (FIG. 2,
`FIG. 3) of the humeral portion;
`a first plant configuration and a revision configuration.
`Thanksto the present invention,it is possible to pass from
`one configuration to another without having to change
`prostheses 10 but only by adding/substituting the appropri-
`ate components within the same prosthesis 10.
`With reference to the figures of the drawings, a total
`shoulder prosthesis with a stem (FIG. 1) or without a stem,
`produced according to the present invention,
`is generally
`indicated with 10 and is modularor structurally composed of
`the following components operationally inter-coupled.
`FIG. 20 shows the implanted prosthesis 10 with the
`anterior-posterior and inferior-superior directions high-
`lighted, with respect to a patient in an upright position.
`The total prosthesis according to the present
`invention
`comprises a humeral portion and a scapular portion, each
`portion being provided with at least one osseointegrable
`componentand articular component.
`The humeral portion of the prosthesis 10 can comprise
`one or more of the following elements:
`a) a humeral body 13, or so-called “humeral core”, which
`allows the passage intraoperatively and with the samepros-
`thetic system from a stemless humeral configuration to a
`stemmed configuration and from an anatomical to an reverse
`configuration.
`The humeral body 13 is made of a metallic material.
`The humeral body 13 can be made of titanium alloy
`Ti6Al4V in powder form (according to the standard ASTM
`F3001).
`The body 13 is produced in the form of a semispherical
`asymmetric cage with multiple arms 132 and having a
`proximal circular ring base 133 suitable for being inter-
`changeably coupled with the articular component such as a
`humeral head 15 for an anatomical prosthesis or a concave
`insert 22 for a reverse prosthesis.
`In particular, the body 13 is produced as a semispherical
`asymmetric cage.
`Asillustrated in the figures, said humeral body 13 pro-
`duced as a semispherical asymmetric cage is in the form of
`a pyramid having as its base the proximalcircular ring base
`133 and as the apex, to which it is connectable, through a
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`connector 12 (as described hereunder) a stem 11, a base 134
`provided opposite and eccentric with respect to said proxi-
`malbase 133.
`
`Said base 134 has a cylindrical form.
`In the embodiments illustrated, said base 134 has a hollow
`cylindrical form so as to housein its interior an end 121 of
`the connector 12.
`
`The coupling between said distal base 134 and connector
`12 is of the morse cone type.
`As can be seen in FIG. 20, in a mounted condition of the
`prosthesis 10, the proximal circular ring base 133 faces the
`scapular portion andthe distal base 134, opposite, is inserted
`into the humerus.
`
`The proximal circular ring base 133 and the distal base
`134 are connected to each other by arms 132.
`As shown in the figures therefore, said humeral body 13
`produced as a semispherical asymmetric cage is hollow
`inside and with empty spaces between adjacent arms 132.
`According to an embodiment illustrated, said humeral
`body 13 is provided with four arms 132.
`Advantageously, of the arms 132 has pass-through holes
`131 for favouring the growth of new bonetissue inside and
`facilitating the anchorage of the body 13 to the bone.
`Asillustrated in FIG. 13, according to a preferred embodi-
`ment, the humeral body 13 has four arms 132 positioned
`asymmetrically with respect to each other, connecting the
`circular ring of the proximal base 133 to the distal base 134
`of the humeral body 13, thus forming a hemispherical cage.
`The four arms 132 are asymmetric with respect to an axis
`Y in an anterior-posterior direction passing through the
`centre of the distal base 134.
`This asymmetry is due to the eccentricity of the distal base
`134 with respect to the proximal base 133 on the transverse
`plane which involves two arms having a greater size and
`length 135 on the lateral side of the distal base 134 with
`respect to the two arms having a smaller size and length 136
`positioned on the medial side of the distal base 134 accord-
`ing to a direction described by an axis X perpendicular to Y.
`These four arms give a greater rotational stability of the
`humeral body (with respect, for example, to a body with
`three flaps such as that described in the prior art), greater
`support on the metaphyseal humeral bone and therefore
`greater stability against a downward distal migration (sink-
`ing) of the humeral body 13.
`The two majorlateral arms 135 are inserted in the bone
`portion of the major tubercle. The two minor medial arms
`136 are inserted in the bone portion of the humeral neck.
`Asillustrated in FIGS. 10a, 11 and in the detail illustrated
`in FIG. 10b, the humeral body 13 has, at least on the outer
`annular side 137 of the proximal circular ring base 133, an
`irregularly isotropically oriented trabecularstructure, highly
`porous to facilitate anchorage by the initial press-fit and its
`osseointegrability and osseoinductivity.
`Said annular outer side 137 has, in fact, a highly porous
`isotropic metalstructure, with interconnected trabeculae and
`irregularly and randomly arranged in space in order to
`favourthe initial anchorage of the humeral body 13 (which
`in one of the embodiments can be stemless) by pressure
`interlocking with the bone of the humeral metaphysis and to
`favour the secondary biological anchorage through its char-
`acter