( 19 ) United States
`( 12 ) Patent Application Publication ( 10 ) Pub . No .: US 2022/0125594 A1
`.
`Apr. 28 , 2022
`( 43 ) Pub . Date :
`Frankle et al .
`
`US 20220125594A1
`
`IN
`
`( 54 ) GLENOID IMPLANT
`( 71 ) Applicant : ENCORE MEDICAL , L.P. ( D / B / A
`DJO SURGICAL ) , Austin , TX ( US )
`( 72 ) Inventors : Mark A. Frankle , Tampa , FL ( US ) ;
`Sergio Gutierrez , Tampa , FL ( US ) ;
`Gerald Williams , Villanova , PA ( US )
`17 / 310,280
`Jan. 27 , 2020
`PCT / US2020 / 015199
`
`( 21 ) Appl . No .:
`( 22 ) PCT Filed :
`( 86 ) PCT No .:
`$ 371 ( c ) ( 1 ) ,
`( 2 ) Date :
`Jul . 27 , 2021
`Related U.S. Application Data
`( 60 ) Provisional application No. 62 / 797,866 , filed on Jan.
`28 , 2019 .
`
`Publication Classification
`
`( 51 ) Int . Ci .
`A61F 2/40
`A61F 2/30
`
`( 2006.01 )
`( 2006.01 )
`
`( 52 ) U.S. CI .
`CPC
`A61F 2/4081 ( 2013.01 ) ; A61F 2/30734
`( 2013.01 ) ; A61F 2002/4085 ( 2013.01 ) ; A61F
`2002/30736 ( 2013.01 ) ; A61F 2002/30433
`( 2013.01 ) ; A61F 2/30749 ( 2013.01 )
`
`( 57 )
`
`ABSTRACT
`
`A glenoid implant includes a base element , a coupling
`element , and an augment . The base element has a central
`aperture , a second aperture , and a wedge element . The
`coupling element has a first portion and a second portion .
`The first portion has a first plurality of apertures and the
`second portion has a central aperture aligned with the central
`aperture of the base element . The augment is received within
`a receiving space of the coupling element . The augment has
`a second plurality of apertures , each of which is aligned with
`each of the first plurality of apertures to receive respective
`second fastening elements . The coupling element and the
`augment are configured to rotate about an axis of the base
`element such that the coupling element and the augment are
`movable relative to the base element .
`
`125
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`@ 151
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`150
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`53
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`125
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`5-5
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`10
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`50
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`FIG . 9
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`CATALYST, EX-1008
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`120
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`265
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`CATALYST, EX-1008
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`Apr. 28 , 2022 Sheet 10 of 76 US 2022/0125594 A1
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`225
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`CATALYST, EX-1008
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`200
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`CATALYST, EX-1008
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`US 2022/0125594 A1
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`Apr. 28 , 2022 Sheet 12 of 76
`200
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`CATALYST, EX-1008
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`215
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`CATALYST, EX-1008
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`Apr. 28 , 2022 Sheet 14 of 76
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`CATALYST, EX-1008
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`Apr. 28 , 2022 Sheet 15 of 76
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`CATALYST, EX-1008
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 16 of 76
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`US 2022/0125594 A1
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`CATALYST, EX-1008
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 17 of 76
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`US 2022/0125594 A1
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`CATALYST, EX-1008
`PAGE 18
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 18 of 76
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`US 2022/0125594 A1
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`CATALYST, EX-1008
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 19 of 76
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`US 2022/0125594 A1
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`CATALYST, EX-1008
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`Apr. 28 , 2022 Sheet 20 of 76
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`550
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`CATALYST, EX-1008
`PAGE 21
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 21 of 76
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`US 2022/0125594 A1
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`CATALYST, EX-1008
`PAGE 22
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`Apr. 28 , 2022 Sheet 22 of 76 US 2022/0125594 A1
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`CATALYST, EX-1008
`PAGE 23
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 23 of 76
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`US 2022/0125594 A1
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`555
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`CATALYST, EX-1008
`PAGE 24
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 24 of 76
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`US 2022/0125594 A1
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`375
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`CATALYST, EX-1008
`PAGE 25
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 25 of 76
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`US 2022/0125594 A1
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`600
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`CATALYST, EX-1008
`PAGE 26
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 26 of 76 US 2022/0125594 A1
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`CATALYST, EX-1008
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`Apr. 28 , 2022 Sheet 27 of 76
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`US 2022/0125594 A1
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`360
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`CATALYST, EX-1008
`PAGE 28
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`mm .
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`CATALYST, EX-1008
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`Apr. 28 , 2022 Sheet 29 of 76 US 2022/0125594 A1
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`FIG . 35
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`360
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`CATALYST, EX-1008
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`Apr. 28 , 2022 Sheet 30 of 76
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`US 2022/0125594 A1
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`710 712 711
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`CATALYST, EX-1008
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`360
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`CATALYST, EX-1008
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`Apr. 28 , 2022 Sheet 32 of 76
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`US 2022/0125594 A1
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`460
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`CATALYST, EX-1008
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`Apr. 28 , 2022 Sheet 33 of 76
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`575
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`CATALYST, EX-1008
`PAGE 34
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`Apr. 28 , 2022 Sheet 34 of 76
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`800
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`CATALYST, EX-1008
`PAGE 35
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`Apr. 28 , 2022 Sheet 35 of 76 US 2022/0125594 A1
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`CATALYST, EX-1008
`PAGE 36
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 36 of 76
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`US 2022/0125594 A1
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`PAGE 37
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 37 of 76
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`PAGE 38
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 38 of 76
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`PAGE 39
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 39 of 76
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`CATALYST, EX-1008
`PAGE 40
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 40 of 76
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 41 of 76
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`PAGE 42
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 42 of 76
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 43 of 76 US 2022/0125594 A1
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`PAGE 44
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 44 of 76
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`PAGE 45
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`Apr. 28 , 2022 Sheet 45 of 76
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`PAGE 46
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`Patent Application Publication
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`Apr , 28 , 2022 Sheet 46 of 76
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`CATALYST, EX-1008
`PAGE 47
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`

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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 47 of 76
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`PAGE 48
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 48 of 76
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`CATALYST, EX-1008
`PAGE 49
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 49 of 76
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`PAGE 50
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 50 of 76
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`US 2022/0125594 A1
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`PAGE 51
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`

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`Patent Application Publication
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`Apr 28 , 2022 Sheet 51 of 76
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`PAGE 52
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 52 of 76
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`PAGE 53
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`Apr. 28 , 2022 Sheet 53 of 76
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`PAGE 54
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 54 of 76
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`PAGE 55
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 55 of 76
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`PAGE 56
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`Patent Application Publication
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`Apr , 28 , 2022 Sheet 56 of 76
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`US2022 / 0125594 A1
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`PAGE 57
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 57 of 76
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`PAGE 58
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`

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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 58 of 76
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`PAGE 59
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 59 of 76
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`US 2022/0125594 A1
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`PAGE 60
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 60 of 76
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`US 2022/0125594 A1
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`PAGE 61
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`

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`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 61 of 76
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`US 2022/0125594 A1
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`1956
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`PAGE 62
`
`

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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 62 of 76
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`US 2022/0125594 A1
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`1915
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`CATALYST, EX-1008
`PAGE 63
`
`

`

`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 63 of 76 US 2022/0125594 A1
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`2020 2021
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`CATALYST, EX-1008
`PAGE 64
`
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 64 of 76
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`US 2022/0125594 A1
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`CATALYST, EX-1008
`PAGE 65
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`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 65 of 76 US 2022/0125594 A1
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`PAGE 66
`
`

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`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 66 of 76 US 2022/0125594 A1
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`2100
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`CATALYST, EX-1008
`PAGE 67
`
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`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 67 of 76 US 2022/0125594 A1
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`2237
`
`91
`
`-2237
`
`-2111
`
`2140
`
`2237
`
`CATALYST, EX-1008
`PAGE 68
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`

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`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 68 of 76 US 2022/0125594 A1
`
`2200
`
`2230 2210
`
`2215
`2255
`
`2215
`2215
`
`93
`
`2237
`
`FIG . 92
`
`2200
`
`2210
`
`2237
`
`FIG . 93
`
`2230 mm 2211
`2255 o 2240
`
`2215
`
`2215
`2215
`
`CATALYST, EX-1008
`PAGE 69
`
`

`

`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 69 of 76
`
`US 2022/0125594 A1
`
`2310
`
`2350
`
`2300
`
`2351
`
`2353
`2330
`
`2353
`
`2352
`
`2331 2335
`
`2331
`
`FIG . 94
`
`
`2331 2331
`2340
`
`2365
`
`2361
`
`2360
`
`CATALYST, EX-1008
`PAGE 70
`
`

`

`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 70 of 76
`
`US 2022/0125594 A1
`
`2300
`
`2310
`
`-2352
`
`2350
`
`2331
`
`2340
`
`2331
`
`2330
`
`FIG . 95
`
`2353
`
`2331
`
`2360
`
`2335 2336 2331
`2363
`
`2361
`
`2365
`
`CATALYST, EX-1008
`PAGE 71
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`

`

`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 71 of 76
`
`US 2022/0125594 A1
`
`2410
`
`2450
`
`2400
`
`2452
`
`2453
`
`2430
`
`2431
`
`2453
`
`2451
`
`FIG . 96
`
`2431
`
`2440
`
`2461
`
`2460
`
`2465
`
`CATALYST, EX-1008
`PAGE 72
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`

`

`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 72 of 76
`
`US 2022/0125594 A1
`
`2400
`
`2450
`
`-2431
`
`2431
`
`2430
`
`2410
`
`2451
`
`O
`
`FIG . 97
`
`2453
`
`2431
`
`2461
`
`2435 2440 2431
`
`Co 2465
`
`2460
`
`CATALYST, EX-1008
`PAGE 73
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`

`

`Patent Application Publication
`
`Apr. 28 , 2022 Sheet 73 of 76
`
`US 2022/0125594 A1
`
`2515
`
`Den 2520
`
`2521
`
`2500
`
`2511
`
`2510
`
`375
`
`2525
`
`2540
`2537
`
`2536
`
`FIG . 98
`
`360
`
`L 1
`
`365
`
`2555
`
`371
`
`370
`
`CATALYST, EX-1008
`PAGE 74
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 74 of 76 US 2022/0125594 A1
`
`50
`
`2555
`
`2520
`2521
`
`53
`
`2540 370
`
`FIG . 99
`
`54
`
`51
`
`2510
`2511
`360
`
`2537
`
`2500
`
`CATALYST, EX-1008
`PAGE 75
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 75 of 76
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`US 2022/0125594 A1
`
`371
`
`370
`
`FIG . 100
`
`365
`
`2640
`
`2611
`
`2610
`
`360
`
`2636
`
`2600
`
`375
`
`2621
`
`2620
`
`0 0
`
`2637
`
`2655
`
`CATALYST, EX-1008
`PAGE 76
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`Patent Application Publication
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`Apr. 28 , 2022 Sheet 76 of 76 US 2022/0125594 A1
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`V
`
`50
`
`54
`
`51
`
`2610
`2637
`
`2600
`
`2640
`
`370
`FIG . 101
`
`2655
`
`2620
`
`53
`
`CATALYST, EX-1008
`PAGE 77
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`

`

`US 2022/0125594 Al
`
`1
`
`Apr. 28 , 2022
`
`GLENOID IMPLANT
`
`CROSS - REFERENCE TO RELATED
`APPLICATION
`This application claims priority to and the benefit
`[ 0001 ]
`of U.S. Provisional Patent Application No. 62 / 797,866 , filed
`Jan. 28 , 2019 , which is hereby incorporated by reference
`herein in its entirety .
`FIELD OF THE PRESENT DISCLOSURE
`[ 0002 ] The present disclosure relates to glenoid implants
`for cases of severe bone loss .
`
`BACKGROUND
`Shoulder replacement surgery is currently used to
`[ 0003 ]
`treat patients suffering from disabling pain due to worn or
`damaged shoulder joints , which can be caused by , e.g. ,
`arthritis and / or injury . The humeral implants currently in use
`are typically made from metal , and the implants are affixed
`to the bone using bone cement ( e.g. , polymethylmethacry
`late ) or by press fitting the implant into the bone using a
`roughened outer surface coating on the metal for bony
`integration . Most glenoid ( shoulder socket ) implants are
`made completely from polyethylene and affixed to the
`cortical bone using bone cement . Some glenoid implants
`have a metal baseplate with a polyethylene insert . Current
`glenoid implants are made to sit on the surface of a reamed
`glenoid , which is prepared by removing any remaining
`cartilage and flattening the bony surface . These implants use
`either a keel or multiple elongated pegs on the back of the
`prosthetic glenoid implant to secure the glenoid implant
`inside the glenoid vault .
`[ 0004 ] Keeled and pegged glenoid implants suffer from
`several disadvantages , which limit their lifespan once
`implanted and reduce the number of indications for which
`they can be used when the age of the patient is a factor . For
`example , the glenoid implants can loosen due to poor
`fixation within the bone , and they are prone to wear and
`fatigue failure of the polyethylene due to adhesion , abrasion ,
`and shear stress . Because of these deficiencies , surgeons
`hesitate to perform glenoid replacement surgery on young or
`middle aged patients with glenoid articular cartilage injuries
`or damage due to early arthritis for fear that the implant may
`not last more than 10-15 years in the body , thus subjecting
`the patient to the possibility of two or more surgeries during
`the lifetime of the patient to preserve the function and
`pain - free state of the joint . Finally , current glenoid implants
`with a long keel or pegs are sometimes contraindicated in
`patients with significant glenoid bone loss . As arthritis
`progresses , the humeral head can wear medially and destroy
`the foundation of glenoid bone . In these cases , the glenoid
`vault can be significantly reduced in volume and depth .
`Thus , a typical keel or peg design can broach the glenoid
`vault and injure the suprascapular nerve along the supras
`capular notch or spinoglenoid notch with resultant denerva
`tion injury to the rotator cuff muscles . Broaching through the
`glenoid vault can also fracture the body of the scapula and
`cause early implant loosening .
`[ 0005 ] Because there are more than 20,000 shoulder artho
`plasty surgeries performed per year , many U.S. patients
`incur a risk of continued pain and disability , neuromuscular
`injuries , or failed shoulder prostheses requiring revision
`surgery . Thus , there remains a need for an improved glenoid
`
`a
`
`implants . The present disclosure is directed to solving these
`problems and addressing other needs .
`
`a
`
`SUMMARY OF THE PRESENT DISCLOSURE
`[ 0006 ] According to some implementations of the present
`disclosure , a glenoid implant includes a base element , a
`coupling element , and an augment . The base element has a
`central aperture , a second aperture , and a wedge element .
`The coupling element has a first portion and a second
`portion . The first portion has a first plurality of apertures and
`the second portion has a central aperture aligned with the
`central aperture of the base element . The augment is
`received within a receiving space of the coupling element .
`The augment has a second plurality of apertures , each of
`which is aligned with each of the first plurality of apertures
`to receive respective second fastening elements . The cou
`pling element and the augment are configured to rotate about
`an axis of the base element such that the coupling element
`and the augment are movable relative to the base element .
`[ 0007 ] According to some implementations of the present
`disclosure , a glenoid implant includes a base element , a
`coupling element and an augment . The base element has a
`central aperture therethrough , a second aperture there
`through , and a wedge element extending from a rear of the
`base element . The second aperture is configured to receive
`a portion of a first fastening element therethrough to aid in
`securing the base element to a first portion of a scapula of a
`patient . The coupling element has a first portion and a
`second portion . The first portion has a first plurality of
`apertures therethrough and the second portion has a central
`aperture aligned with the central aperture of the base ele
`ment . The augment is configured to be received within a
`receiving space of the first portion of the coupling element .
`The augment has a second plurality of apertures there
`through . Each of the first plurality of apertures is aligned
`with each of the second plurality of apertures to receive a
`respective second fastening element therethrough to aid in
`securing the coupling element and the augment to a second
`portion of the scapula of the patient . The coupling element
`and the augment are configured to rotate about an axis of the
`base element such that the coupling element and the aug
`ment are movable relative to the base element .
`[ 0008 ] According to some implementations of the present
`disclosure , a glenoid implant includes a base element , a
`coupling element , and an augment . The base element has a
`trunnion forming a central aperture therethrough and an
`attachment portion adjacent to the trunnion . The base ele
`ment further forms a second aperture that is configured to
`receive a portion of a first fastening element therethrough to
`a
`aid in coupling the base element to a first portion of a scapula
`of a patient . The coupling element has a first portion and a
`second portion . The first portion has a plurality of apertures
`therethrough and the second portion having a central aper
`ture aligned with the central aperture of the base element .
`The augment is configured to be received within a receiving
`space of the first portion of the coupling element . The
`augment has a second plurality of apertures therethrough .
`Each of the first plurality of apertures is aligned with each
`of the second plurality of apertures to receive a respective
`second fastening element therethrough to aid in securing the
`coupling element and the augment to a second portion of the
`scapula of the patient . The coupling element and the aug
`ment are configured to rotate about an axis of the base
`
`a
`
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`US 2022/0125594 A1
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`2
`
`Apr. 28 , 2022
`
`a
`
`a
`
`element such that the coupling element and the augment are
`movable relative to the base element .
`[ 0009 ] According to some implementations of the present
`disclosure , a glenoid implant includes a baseplate , a first leg
`and a second leg . The baseplate includes a central aperture
`therethrough . The first leg extends from the baseplate gen
`erally along a first arc . The first leg includes a first aperture
`therein configured to receive a portion of a first fastening
`element therethrough to aid in securing the first leg to a first
`portion of a scapula of a patient . The second leg extends
`from the baseplate generally along a second arc . The second
`leg includes a second aperture therein configured to receive
`a portion of a second fastening element therethrough to aid
`in securing the second leg to a second portion of the scapula
`of the patient .
`[ 0010 ]
`In some implementations , a radius of curvature for
`the first arc is larger than a radius of curvature for the second
`arc . In an alternative implementation , a radius of curvature
`for the first arc is the same as a radius of curvature for the
`second arc . In an alternative implementation , a radius of
`curvature for the second arc is larger than a radius of
`curvature for the first arc . The first portion of the scapula of
`the patient can be an Acromion . The second portion of the
`scapula of the patient can be a Coracoid .
`[ 0011 ] The glenoid implant can also include a third leg
`extending from the baseplate generally along a third
`The
`arc .
`third leg can have a third aperture therein configured to
`receive a portion of a third fastening element therethrough to
`aid in securing the third leg to a third portion of the scapula
`of the patient . In some implementations , a radius of curva
`ture for the third arc is smaller than a radius of curvature for
`?
`the second arc and a radius of curvature for the first arc . In
`a
`some alternative implementations , the radius of curvature
`for the third arc is the same as a radius of curvature for the
`second arc and a radius of curvature for the first arc . The
`third portion of the scapula of the patient can be an Infragle
`noid tubercle ( also referred to as the lateral boarder of the
`scapula ) and / or the For Subscapularis .
`[ 0012 ]
`In some implementations , the baseplate includes a
`first portion coupled to a second portion such that the central
`aperture is defined by both the first portion and the second
`portion . The first portion of the baseplate , the first leg , and
`the second leg can form a first monolithic part . Furthermore ,
`a
`the second portion of the baseplate and the third leg can form
`a second monolithic part that is separate and distinct from
`the first monolithic part .
`[ 0013 ]
`In some implementations , the first leg , the second