*: t'
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`-- -F-?:
`
`NUMBER !
`
`PATENT
`
`A RT UN IT
`U N I T
`
`UP
`
`- - 2 - _ _ _ -
`EXAMINER
`EXAMINER
`
`-
`
`
`
`:
`
`i'
`/
`
`REGULAP L1iITY
`--
`
`Form P10-43
`(Rev. 8118)
`
`5Li1S2
`
`11979)
`
`•1
`
`-
`-
`
`SERIAL NUMBER
`SERIAL NUMBER
`O6/51 ,52
`c!6/541,F52
`
`FILNDATE CLASS
`10/14/83
`
`128
`JAMFS F. JFPVIS, ATHERTON, CA.
`I**CONTTNUING
`V#I FIE!)
`
`-
`SUBCLASS
`SUBCLASS
`(5 -3
`
`(P2
`
`**FOREIGN/PCT APPLICATIONS************
`VERIFIED /
`
`FOREIGN EI1IG LICENSE GRANTED 11/08/83
`
`Foreign priority claimed
`Dyes
`Foreign priority claimed
`35 USC llgconditionsmet Dyes
`35 USC 119 conditions met
`
`AS
`
`I
`
`,
`
`I
`
`ATTORNEY'S
`FILING FEE
`STATE OR SHEETS TOTAL
`DOCKET NO.
`IhF'J0Et'.
`TNO.
`D0
`COUNTRY DRWGS. CLAIMS LAIMS RECEIVED
`1 $ 300. 0 VPO884us I
`10
`..Zi D. 8/ecAer ,qe,it V4
`(
`&c12.k.e.n-. aorpara4:cr.%
`
`CA
`
`1
`
`Verified and Acknowledged
`
`Examiner's Initials
`
`COTTTUTi0-N--!V-
`
`TtfEVTUS I N C OR
`
`I.-
`
`<-ILO-FARK, CA 90-24- 3oJ/
`
`/Y1cnlo Pr-k1 c2a. 91/à2-t5
`
`\
`
`Z 7C3
`
`U.S. DEPT. of COMM.-Pat. & TM Office — PTO-436L (rev. 10-78)
`
`-/1i 'j1
`
`PARTS OF APPLICATION FILED SEPARATELY
`
`PREPARED FOR ISSUE
`
`AT ALL
`
`SUBCLASS
`
`I Assistant Examiner)
`
`PASSED FOR
`
`EXAM I N ER
`
`GROUpAp
`
`(Primary Examiner)
`Estimate of printed pages
`
`— — —
`
`(Art Unit)
`Issue flee due (est.)
`
`t
`
`Drawing(s)
`
`Scecls)
`
`Notice of allowance arid issue fee due (sit.)
`Date mailed
`Date paid
`
`RETENTION LABEL
`
`COOK
`Exhibit 1003-0001
`
`

`

`t
`
`•1
`
`-'
`
`0
`
`541852
`
`Entered
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`I________
`
`12.
`
`i AA
`
`CONTEN i
`
`'883
`
`//
`
`, /rd5;'
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`O4fl 1--•
`.-,C) \'i2--
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`I
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`IEU
`AUG 25 1986
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`V;I
`
`*U I. QOVNMINT PRINTING ,FrICt i9823a95e2i
`
`I
`
`COOK
`Exhibit 1003-0002
`
`

`

`SEARCHED
`Date
`Sub
`
`Ez'r
`
`Class
`
`SEARCHED - Sub
`'77_ i1_ctrfc
`4-
`— tZ 1
`(2 jZ
`ti3)
`
`e7z
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`.
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`-
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`
`[E SEARCHED!
`
`ClI388
`
`— S —
`
`Date
`
`I
`
`rl
`
`PRINT CLAIM (S) : 4
`
`STATU8
`SYMBOLS
`SYMBOLS
`STATUS
`\r rejected
`V
`Rejected
`-
`- ................................... Allowed
`Allowed
`- (Through numeral) Csncclcd
`— (Throughnumeral) Cancelcd
`-
`÷
`: ................................... Restriction requirement
`Restriction requbement
`N ................................... Nonelect,ed invention or spedes
`N
`Nonelected invention or species
`I .................................... Tntmference
`I
`Thtcrference
`............-..... Appeal
`A@.. -.... ..I..
`Apxea1
`0 ....----- ...... -..-
`0
`Qbjectea
`...
`_.Objected
`
`..
`
`.
`
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`--
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`---.---
`
`__
`
`.
`
`COOK
`Exhibit 1003-0003
`
`

`

`.i P•ft— s:'- C1tO)
`
`L1852
`
`OF t AltNTS AND TRADEMARKS, Washingtm, D.C.
`20231.
`R OF 1LNTS AND TRADEMARKS, Washington, D.C. 2023t
`
`E. JEIWIS
`
`Medical Devices Incorporating SIM Alloy Elements
`
`ransmitted herewith for f i l i n g is t h e pbtent application o f
`rransmitted herewith for filing is the patent application of
`E. JERVIS
`Medical Devices Incorporating SIM Alloy Elements
`I n a d d i t i o n t o t h e s p e c i f i c a t i o n and signed d e c l a r d i o n , enclosed herewith are:
`In addition to the specification and signed declaration, enclosed herewith are:
`EJ ____
`D 1 s h e e t ( s ) o f drawing.
`sheet(s) of drawing. (Informal)
`(Informal)
`An assignment o f t h e invention t o Raychem Corporation
`D A c e r t i f i e d copy o f a
`application.
`application.
`
`1
`
`An assignment of the invention to Paychem Corporation
`
`A certified copy of a
`
`-
`
`.
`
`I.
`
`The f i l i n g fee h a s been c a l c u l a t e d as shown below:
`Th,e filing fee has been calculated as shown below:
`
`FOR
`FOR
`
`Col. I
`NO. FILED
`NO. FILED
`
`Col. 2
`
`OTHER THAN A
`SMALL ENTITY
`
`' NO. EXTRA
`NO. EXTRA
`
`RATE
`RATE
`
`I
`
`.
`.
`
`I
`
`FEE
`FEE
`
`$300
`$300
`
`$
`$
`
`$
`
`S $
`
`$
`$ 300.00
`
`x l o=
`xlO:
`x30=
`x30
`+1 oo=
`+1O0
`
`TOTAL
`
`,BASIC FEE
`BASIC FEE
`
`, TOTAL CLAIMS
`TOTAL CLAIMS
`
`INDEP CLAIMS
`INDEP CLAIMS
`
`c
`
`.
`
`1
`
`*
`*
`10 -20=
`10 —2O
`*
`*
`1 -3=
`0 MULTIPLE DEPENDENT CLAIM PRESENTED
`I7 MULTIPLE DEPEmENT**CLAIM PRESENTa
`* If the difference in Col. 1 is less
`than zero, enter "0" in Col. 2
`
`$
`
`20.00
`
`$ 320-00 .
`
`ASSIGNMENT RECORDATION FEE ($20.00)
`Please charge my Deposit Account No. 18—0560 in the
`P l e a s e charge my Deposit Account No. 18-0560 i n t h e amount of
`amount of
`A duplicate copy of this sheet is enclosed.
`A d u p l i c a t e copy o f t h i s s h e e t is enclosed.
`The Commissioner is hereby authorized t o charge payment of any additional fees,
`The Commissioner is hereby authorized to charge payment of any additional fees,
`i n p a r t i c u l a r t h e following fees, associated with t h i s communication, or c r e d i t
`in particular the following fees, associated with this communiation, or credit
`arly Overpayment, t o Deposit Account No. 18-0560.
`any overpayment, to Deposit Account No. 18—0560.
`Any a d d i t i o n a l f i l i n g fees required under 37 CFR 1.16.
`Any additional filing fees required under 37 CER 1.16.
`Any patent application processing fees under 37 CER 1.17.
`Any p a t e n t a p p l i c a t i o n processing fees under 37 CFR 1.17.
`The Commissioner is hereby authorized t o charge payment of any additional fees,
`The Commissioner is hereby authorized to charge payment of any additional fees,
`i n p a r t i c u l a r t h e following f e e s , during t h e pendency of t h i s application, or
`in particular the following fees, during the pendency of this application, or
`c r e d i t any overpayment, t o Deposit Account No. 18-0560.
`credit any overpayment, to Deposit Account No. 18—0560.
`Any p a t e n t a p p l i c a t i o n processing fees under 37 CFR 1.17.
`Any patent application processing fees under 37 CFR 1.17.
`T h e issue f e e s e t i n 37 CFR 1.18 a t or before mailing o f t h e Notice of
`The issue fee set in 37 CFR 1.18 at or before mailing of the Notice of
`Allowance, pursuant t o 37 CFR 1.31l(b).
`A1]owance, pursuant to 37 CFR 1.311(b).
`Arty filing fees under 37 CER 1.16 for presentation of extra claims.
`Ariy f i l i n g fees under 37 CFR 1.16 f o r p r e s e n t a t i o n of e x t r a claims.
`
`$_320.00
`
`e-
`
`( Jmes W. .Petason
`R'gistration No. 26,057
`
`Respect f u l l y submitted
`Respectfully submitted
`
`nu m be r
`t ? U K ? k f
`
`' mslllng label
`"Erpres: : , I ? , :
`"Express MaT' rnaiing Iab&
`B35248436
`B35248436
`DaoL_0Ct0b 14, 1983
`:t this paper or fee is being
`Lj-Taj States Po,tal Service
`C co4aPdorcee scrice
`U n the ate indct above
`the Cornrnisoer of
`Washington, D.C. 20231.
`Diane Browning
`(Typei r pnted name)
`
`-
`
`E r
`
`/1'
`
`COOK
`Exhibit 1003-0004
`
`

`

`,
`
`2
`
`' 1852/?
`
`M
`MP 08 84—U Si
`
`MEDICAL D E V I C E S I N C O R P O R A T I N G
`MEDICAL DEVICES INCORPORATING
`SIM ALLOY ELEMENTS
`SIM ALLOY ELEMENTS
`
`James E. J e r v i s
`James E. Jervis
`
`A B S T R A C T OF THE DISCLOSURE
`ABSTRACT OF THE DISCLOSURE
`
`Medical devices which are currently proposed to use
`M e d i c a l d e v i c e s w h i c h a r e c u r r e n t l y p r o p o s e d t o u s e
`elements made from shape memory alloys may be improved by
`e l e m e n t s made f r o m s h a p e memory a l l o y s may b e i m p r o v e d b y
`the use of stress—induced martensite alloy elements instead.
`t h e u s e o f s t r e s s - i n d u c e d m a r t e n s i t e a l l o y e l e m e n t s i n s t e a d .
`The use of stress—induced martensite decreases the temperature
`The u s e o f s t r e s s - i n d u c e d m a r t e n s i t e d e c r e a s e s t h e t e m p e r a t u r e
`sensitivity of the devices, thereby making them easier to
`s e n s i t i v i t y o f t h e d e v i c e s ,
`t h e r e b y m a k i n g t h e m e a s i e r t o
`install and/or remove.
`i n s t a l l a n d / o r
`r e m o v e .
`
`5
`5
`
`•
`
`B35248436
`
`.Qctobr. l41a3
`. October 14, -1983
`
`1
`
`r- __
`-
`- -. Diane -- Browning
`Diane Browning
`
`..
`
`..
`
`COOK
`Exhibit 1003-0005
`
`

`

`a 2
`a2
`
`MP0884-US1
`MP0884—US1
`
`- 2 -
`—2—
`
`I N V E N T I O N
`BACKGROUND OF THE
`BACKGROUND OF THE INVENTION
`
`F i e l d o f t h e I n v e n t i o n
`Field of the Invention
`
`T h i s i n v e n t i o n r e l a t e s t o m e d i c a l d e v i c e s i n c o r p o r a t i n g
`This invention relates to medical devices incorporating
`s h a p e memory a l l o y s , a n d t o i m p r o v e m e n t s t h e r e i n .
`shape memory alloys, and to improvements therein.
`
`5
`
`5
`
`Introduction to the Invention
`I n t r o d u c t i o n t o t h e I n v e n t i o n
`
`10
`
`M a t e r i a l s , b o t h o r g a n i c a n d m e t a l l i c , c a p a b l e
`Materials, both organic and metallic, capable
`of possessing shape memory are well known. An article
`o f p o s s e s s i n g s h a p e memory a r e w e l l known.
`An a r t i c l e
`made of such materials can be deformed from an original,
`made o f s u c h m a t e r i a l s c a n b e d e f o r m e d f r o m a n o r i g i n a l ,
`heat—stable configuration to a second, heat—unstable
`h e a t - s t a b l e c o n f i g u r a t i o n t o a s e c o n d , h e a t - u n s t a b l e
`configuration. The article is said to have shape
`10 c o n f i g u r a t i o n .
`The a r t i c l e i s s a i d t o h a v e s h a p e
`memory for the reason that, upon the application of
`memory f o r t h e r e a s o n t h a t , u p o n t h e a p p l i c a t i o n o f
`heat alone, it can be caused to revert, or to attempt
`i t c a n b e c a u s e d t o r e v e r t , o r t o a t t e m p t
`h e a t a l o n e ,
`to revert, from its heat—unstable configuration to its
`t o r e v e r t ,
`f r o m i t s h e a t - u n s t a b l e c o n f i g u r a t i o n t o i t s
`original, heat—stable configuration, i.e. it "remembers"
`i t " r e m e m b e r s "
`o r i g i n a l , h e a t - s t a b l e c o n f i g u r a t i o n ,
`i . e .
`its original shape.
`15 i t s o r i g i n a l s h a p e .
`15
`
`20
`*O
`
`Among m e t a l l i c a l l o y s ,
`t h e a b i l i t y t o p o s s e s s s h a p e
`Among metallic alloys, the ability to possess shape
`memory is a result of the fact that the alloy undergoes
`i s a r e s u l t o f t h e f a c t t h a t t h e a l l o y u n d e r g o e s
`memory
`a reversible transformation from an austenitic state to
`a r e v e r s i b l e t r a n s f o r m a t i o n f r o m a n a u s t e n i t i c s t a t e t o
`a martensitic state with a change in temperature. This
`a m a r t e n s i t i c s t a t e w i t h a c h a n g e i n t e m p e r a t u r e .
`T h i s
`transformation is sometimes referred to as a thermoelastic
`t r a n s f o r m a t i o n i s s o m e t i m e s r e f e r r e d t o a s a
`t h e r m o e l a s t i c
`martensitic transformation. An article made from such an
`An a r t i c l e made
`m a r t e n s i t i c t r a n s f o r m a t i o n .
`f r o m s u c h a n
`a l l o y , f o r e x a m p l e a h o l l o w s l e e v e , i s e a s i l y d e f o r m e d f r o m
`alloy, for example a hollow sleeve, is easily deformed from
`its original configuration to a new configuration when
`i t s o r i g i n a l c o n f i g u r a t i o n t o a new c o n f i g u r a t i o n when
`cooled below the temperature at which the alloy is trans—
`c o o l e d b e l o w t h e t e m p e r a t u r e a t w h i c h t h e a l l o y i s t r a n s -
`formed from the austenitic state to the martensitic state.
`25
`25 f o r m e d
`f r o m t h e a u s t e n i t i c s t a t e t o t h e m a r t e n s i t i c s t a t e .
`
`COOK
`Exhibit 1003-0006
`
`

`

`a3
`a3
`
`MP0884-US1
`MP0884—US1
`
`- 3 -
`—3—
`
`The t e m p e r a t u r e a t which t h i s t r a n s f o r m a t i o n b e g i n s i s
`The temperature at which this transformation begins is
`a n d t h e t e m p e r a t u r e a t w h i c h i t
`u s u a l l y r e f e r r e d t o a s M
`usually referred to as M5 and the temperature at which it
`S
`finishes Mf. When an article thus deformed is warmed to
`f i n i s h e s M f . When a n a r t i c l e t h u s d e f o r m e d i s warmed t o
`t h e t e m p e r a t u r e a t w h i c h t h e a l l o y s t a r t s t o r e v e r t b a c k t o
`the temperature at which the alloy starts to revert back to
`( A f b e i n g t h e t e m p e r a t u r e
`a u s t e n i t e , r e f e r r e d t o a s A s
`austenite, referred to as A5 (Af being the temperature
`t h e d e f o r m e d o b j e c t w i
`l
`l
`at which the reversion is complete) the deformed object will
`a t w h i c h t h e r e v e r s i o n i s c o m p l e t e )
`b e g i n t o r e t u r n t o i t s o r i g i n a l c o n f i g u r a t i o n .
`begin to return to its original configuration.
`
`
`
`Many s h a p e memory a l l o y s ( S M A s ) a r e known t o d i s p l a y
`Many shape memory alloys (SMAs) are known to display
`stress—induced martensite (SIM). When an SMA sample exhibit—
`s t r e s s - i n d u c e d m a r t e n s i t e ( S I M ) . When a n SMA s a m p l e e x h i b i t -
`ing stress—induced martensite is stressed at a temperature
`i n g s t r e s s - i n d u c e d m a r t e n s i t e i s s t r e s s e d a t a
`t e m p e r a t u r e
`above M (so that the austenitic state is initially
`a b o v e M s ( s o t h a t t h e a u s t e n i t i c s t a t e i s i n i t i a l l y
`s t a b l e ) , b u t b e l o w Md
`stable), but below Md (the maximum temperature at which
`( t h e maximum t e m p e r a t u r e a t w h i c h
`m a r t e n s i t e f o r m a t i o n c a n o c c u r e v e n u n d e r s t r e s s ) i t f i r s t
`martensite formation can occur even under stress) it first
`deforms elastically and then, at a critical stress, begins
`d e f o r m s e l a s t i c a l l y a n d t h e n , a t a c r i t i c a l s t r e s s , b e g i n s
`to transform by the formation of stress—induced martensite.
`t o t r a n s f o r m b y t h e f o r m a t i o n o f s t r e s s - i n d u c e d m a r t e n s i t e .
`D e p e n d i n g o n w h e t h e r t h e t e m p e r a t u r e i s a b o v e o r b e l o w A s ,
`Depending on whether the temperature is above or below A8,
`the behavior when the deforming stress is released differs.
`t h e b e h a v i o r when t h e d e f o r m i n g s t r e s s i s r e l e a s e d d i f f e r s .
`If the temperature is below A5, the stress—induced martensite
`I f t h e t e m p e r a t u r e i s b e l o w A s ,
`t h e s t r e s s - i n d u c e d m a r t e n s i t e
`i s s t a b l e ; b u t i f t h e t e m p e r a t u r e i s a b o v e A s ,
`is stable; but if the temperature is above A8, the martensite
`t h e m a r t e n s i t e
`is unstable and transforms back to austenite, with the
`i s u n s t a b l e a n d t r a n s f o r m s b a c k t o a u s t e n i t e , w i t h t h e
`s a m p l e r e t u r n i n g ( o r a t t e m p t i n g t o r e t u r n ) t o i t s o r i g i n a l
`sample returning (or attempting to return) to its original
`shape. The effect is seen in almost all alloys which
`s h a p e .
`The e f f e c t i s s e e n i n a l m o s t a l
`l a l l o y s w h i c h
`exhibit a thermoelastic martensitic transformation, along
`e x h i b i t a
`t h e r m o e l a s t i c m a r t e n s i t i c t r a n s f o r m a t i o n , a l o n g
`w i t h t h e s h a p e memory e f f e c t . H o w e v e r ,
`with the shape memory effect. However, the extent of the
`t h e e x t e n t o f t h e
`temperature range over which SIM is seen and the stress and
`t e m p e r a t u r e r a n g e o v e r w h i c h S I M i s s e e n a n d t h e s t r e s s a n d
`s t r a i n r a n g e s f o r t h e e f f e c t v a r y g r e a t l y w i t h t h e a l l o y .
`strain ranges for the effect vary greatly with the alloy.
`
`5
`5
`
`lo
`
`15
`
`l5
`
`*'
`
`20
`
`25
`25
`
`'
`
`k
`
`t
`
`
`
`30
`30
`
`I n c o p e n d i n g a n d commonly a s s i g n e d U.S. P a t e n t A p p l i c -
`In copending and commonly assigned U.S. Patent Applic—
`ation (Docket No. MP0873—US1) to 1uithe disclosure of
`a t i o n ( D o c k e t No. MP0873-US11
`t o
`d i s c l o s u r e o f
`which is incorporated herein by refence, a nickel/titanium/
`w h i c h i s i n c o r p o r a t e d h e r e i n b y
`a n i c k e l / t i t a n i u m /
`vanadium alloy having SIM over a wide temperature range is
`v a n a d i u m a l l o y h a v i n g S I M o v e r a w i d e t e m p e r a t u r e r a n g e i s
`d i s c l o s e d .
`disclosed.
`
`COOK
`Exhibit 1003-0007
`
`

`

`a 4
`a4
`
`MP0884-US1
`MP0884—US1
`
`-4-
`-4--
`
`S h a p e memory a l l o y s h a v e f o u n d u s e i n r e c e n t y e a r s i n ,
`Shape memory alloys have found use in recent years in,
`f o r e x a m p l e , p i p e c o u p l i n g s ( s u c h a s a r e d e s c r i b e d i n U.S.
`for example, pipe couplings (such as are described in U.S.
`V
`/
`J
`Pat. Nos. 4,035,007 and 4,198,081 to Harrison and Jervis),
`-
`t o H a r r i s o n and J e r v i s ) ,
`P a t . Nos. 4 , 0 3 5 , 0 0 7 and 4 , 1 9 8 , 0 8 1
`e l e c t r i c a l c o n n e c t o r s ( s u c h a s a r e d e s c r i b e d i n U.S. P a t . No
`electrical connectors (such as are described in U.S. Pat. No
`/
`3,740,839'(o Otte & Fischer) witches (such as are described
`3 , 7 4 0 , 8 3 9 t o O t t e & F i s c h e r ) , / s w i t c h e s ( s u c h a s a r e d e s c r i b e d
`i n U.S. P a t e n t No. 4 , 2 0 5 , 2 9 3 ) , a c t u a t o r s , e t c .
`in U.S. Patent No. 4,205,293), actuators, etc.
`
`
`
`'
`
`\
`
`
`
`V a r i o u s p r o p o s a l s h a v e a l s o b e e n made t o employ s h a p e
`Various proposals have also been made to employ shape
`F o r e x a m p l e , U.S. P a t .
`memory a l l o y s i n t h e m e d i c a l f i e l d .
`memory alloys in the medical field. For example, U.S. Pat.
`/
`No. 3 , 6 2 0 , 2 1 2 t o Fannon e t a l . p r o p o s e s t h e use o f a n SMA
`No. 3,620,212 to Fannon et al. proposes the use of an SMA
`is
`V 10 intrauterine contraceptive device, U.S. Pat. No. 3,786,806
`\ b l o
`i n t r a u t e r i n e c o n t r a c e p t i v e d e v i c e , U.S. P a t . No. 3 , 7 8 6 , 8 0 6 '
`t o J o h n s o n e t a l . p r o p o s e s t h e u s e o f a n SMA bone p l a t e ,
`to Johnson et al. proposes the use of an SMA bone plate,
`/
`/
`P a t . No. 3 , 8 9 0 , 9 7 7 t o W i l s o n p r o p o s e s t h e use o f an SMA
`U.S. Pat. No. 3,890,977 to Wilson proposes the use of an SMA
`U.S.
`e l e m e n t t o bend a c a t h e t e r o r c a n n u l a , e t c .
`element to bend a catheter or cannula, etc.
`
`\
`", 'i
`yL ', %,
`\
`
`I
`
`"
`
`\
`
`,
`
`L
`/
`
`These m e d i c a l SMA d e v i c e s r e l y on t h e p r o p e r t y o f s h a p e
`These medical SMA devices rely on the property of shape
`15 memory to achieve their desired effects. That is to say,
`l5 memory t o a c h i e v e t h e i r d e s i r e d e f f e c t s . That i s t o s a y ,
`t h e y r e l y on t h e f a c t t h a t w h e n a n SMA e l e m e n t i s c o o l e d t o
`they rely on the fact that when an SMA element is cooled to
`i t s m a r t e n s i t i c s t a t e and i s s u b s e q u e n t l y d e f o r m e d , i t w i
`l
`l
`
`its martensitic state and is subsequently deformed, it will
`r e t a i n i t s new s h a p e ; b u t when i t i s warmed
`t o i t s a u s t e n i t i c
`retain its new shape; but when it is warmed to its austenitic
` b e r e c o v e r e d .
`s t a t e , t h e o r i g i n a l s h a p e w i
`l
`l
`state, the original shape will be recovered.
`
`20
`20
`
`t h e use o f t h e s h a p e memory e f f e c t i n m e d i c a l
`However,
`However, the use of the shape memory effect in medical
`a p p l i c a t i o n s i s a t t e n d e d w i t h two p r i n c i p a l d i s a d v a n t a g e s .
`applications is attended with two principal disadvantages.
`F i r s t , i t i s d i f f i c u l t t o c o n t r o l t h e t r a n s f o r m a t i o n t e m p e r -
`First, it is difficult to control the transformation temper-
`a t u r e s o f s h a p e memory a l l o y s w i t h a c c u r a c y a s t h e y a r e
`atures of shape memory alloys with accuracy as they are
`a l t h o u g h v a r i o u s
`u s u a l l y e x t r e m e l y c o m p o s i t i o n - s e n s i t i v e ,
`usually extremely composition—sensitive, although various
`2 5
`25 tech,piques have been proposed (including the blending by
`t - e c h p i q u e s h a v e b e e n p r o p o s e d ( i n c l u d i n g t h e b l e n d i n g by
`6 5.
`3 E' cf"
`p o w e q m e t a l l u r g y o f a l r e a d y - m a d e a l l o y s o f d i f f e r i n g t r a n s -
`powermetallurgy of already—made alloys of differing trans-
`V
`/ -
`s e e U.S.
`f o r m a t i o n t e m p e r a t u r e s :
`P a t . No. 4 , 3 1 0 , 3 5 4 t o
`formation temperatures: see U.S. Pat. No. 4,310,354 to
`F o u n t a i n e t a l . ) .
`i n many s h a p e memory a l l o y s t h e r e
`S e c o n d ,
`Fountain et a].). Second, in many shape memory alloys there
`
`j"
`
`COOK
`Exhibit 1003-0008
`
`

`

`a5
`a5
`
`MP 08 64-US 1
`MP0884—IJS1
`
`- 5 -
`—5—
`
`i s a
`l a r g e h y s t e r e s i s a s t h e a l l o y i s t r a n s f o r m e d b e t w e e n
`is a large hysteresis as the alloy is transformed between
`austenitic and martensitic states, so that reversing of the
`a u s t e n i t i c a n d m a r t e n s i t i c s t a t e s , s o t h a t r e v e r s i n g o f t h e
`s t a t e o f a n SMA e l e m e n t may r e q u i r e a
`t e m p e r a t u r e e x c u r s i o n
`state of an SMA element may require a temperature excursion
`of several tens of degrees Celsius. The combination of these
`o f s e v e r a l t e n s o f d e g r e e s C e l s i u s .
`The c o m b i n a t i o n o f t h e s e
`t h t h e l i m i t a t i o n t h a t ( a ) i t is i n c o n v e n i e n t t o
`f a c t o r s w i
`factors with the limitation that (a) it is inconvenient to
`h a v e t o e n g a g e i n a n y t e m p e r a t u r e m a n i p u l a t i o n , a n d ( b )
`have to engage in any temperature manipulation, and (b)
`human t i s s u e c a n n o t b e h e a t e d o r c o o l e d b e y o n d c e r t a i n
`human tissue cannot be heated or cooled beyond certain
`r e l a t i v e l y n a r r o w l i m i t s ( a p p r o x i m a t e l y 0 " - 6 0 ° C
`relatively narrow limits (approximately 0° — 60°C for short
`f o r s h o r t
`p e r i o d s ) w i t h o u t s u f f e r i n g t e m p o r a r y o r p e r m a n e n t damage is
`periods) without suffering temporary or permanent damage is
`e x p e c t e d t o l
`i m i
`t
` t h e u s e t h a t c a n b e made o f SMA m e d i c a l
`expected to limit the use that can be made of SMA medical
`d e v i c e s . I t w o u l d t h u s b e d e s i r a b l e t o d e v e l o p a way
`i n
`devices. It would thus be desirable to develop a way in
`w h i c h t h e a d v a n t a g e o u s p r o p e r t y o f s h a p e memory a l l o y s ,
`which the advantageous property of shape memory alloys,
`i.e. their ability to return to an original shape after
`i . e .
`t h e i r a b i l i t y t o r e t u r n t o a n o r i g i n a l s h a p e a f t e r
`relatively substantial deformation, could be used in medical
`r e l a t i v e l y s u b s t a n t i a l d e f o r m a t i o n , c o u l d be u s e d i n m e d i c a l
`devices without requirinci the delicacy of alloying control
`d e v i c e s w i t h o u t r e q u i r i n g t h e d e l i c a c y o f a l l o y i n g c o n t r o l
`t h e t e m p e r a t u r e c o n t r o l o f p l a c e m e n t o r r e m o v a l
`and/or the temperature control of placement or removal
`a n d / o r
`needed by present shape memory alloy devices.
`n e e d e d b y p r e s e n t s h a p e memory a l l o y d e v i c e s .
`
`,
`
`D E S C R I P T I O N O F THE
`DESCRIPTION OF THE INVENTION
`I N V E N T I O N
`
`Summary of the Invention
`Summary o f t h e I n v e n t i o n
`
`I h a v e d i s c o v e r e d t h a t i f , i n a m e d i c a l d e v i c e c o n t a i n i n g
`I have discovered that if, in a medical device containing
`a s h a p e memory a l l o y e l e m e n t w h i c h u s e s t h e s h a p e memory
`a shape memory alloy element which uses the shape memory
`property of that alloy, an element which shows the property
`p r o p e r t y o f t h a t a l l o y , a n e l e m e n t w h i c h s h o w s t h e p r o p e r t y
`o f s t r e s s - i n d u c e d . m a r t e n s i t e i s u s e d i n s t e a d , a n i m p r o v e d d e v i c e
`of stress—induced martensite is used instead, an improved device
`r e s u l t s .
`results.
`
`Accordingly, this invention provides a medical device
`t h i s i n v e n t i o n p r o v i d e s a m e d i c a l d e v i c e
`A c c o r d i n g l y ,
`i n t e n d e d f o r u s e w i t h i n a m a m m a l i a n b o d y , o r i n s u c h p r o x i m i t y
`intended for use within a mammalian body, or in such proximity
`to a mammalian body that the device is substantially at body
`t o a m a m m a l i a n b o d y t h a t t h e d e v i c e i s s u b s t a n t i a l l y a t b o d y
`t e m p e r a t u r e , w h i c h d e v i c e c o m p r i s e s a s h a p e memory a l l o y
`temperature, which device comprises a shape memory alloy
`i n w h i c h c o m p r i s e s t h e s u b s t i t u t i o n
`element, the improvement in which comprises the substitution
`e l e m e n t ,
`t h e i m p r o v e m e n t
`o f a n a l l o y e l e m e n t w h i c h d i s p l a y s s t r e s s - i n d u c e d m a r t e n s i t e
`of an alloy element which displays stress—induced martensite
`a t s a i d b o d y t e m p e r a t u r e f o r t h e s h a p e memory a l l o y e l . e m e n t .
`at said body temperature for the shape memory alloy element.
`
`l o
`10
`
`15
`l5
`
`2 0
`20
`
`25
`2 5
`
`30
`30
`
`COOK
`Exhibit 1003-0009
`
`

`

`.I-
`
`,
`
`a6
`a6
`
`MP0884-US1
`MP0884—US1
`
`- 6 -
`—6—
`
`B r i e f D e s c r i p t i o n o f t h e D r a w i n g
`Brief Description of the Drawing
`
`F i g u r e s 1 a n d 2
`Figures 1 and 2 illustrate the stress—strain behavior
`i l l u s t r a t e t h e s t r e s s - s t r a i n b e h a v i o r
`o f a n a l l o y which e x h i b i t s c o n s t a n t s t r e s s v e r s u s s t r a i n
`of an alloy which exhibits constant stress versus strain
`behavior due to stress—induced martensite.
`b e h a v i o r d u e t o s t r e s s - i n d u c e d m a r t e n s i t e .
`
`5
`5
`
`Detailed Description of the Preferred Embodiments
`D e t a i l e d D e s c r i D t i o n o f t h e P r e f e r r e d E m b o d i m e n t s
`
`The invention will be discussed first by introducing
`l
`l
` b e d i s c u s s e d f i r s t b y i n t r o d u c i n g
`The i n v e n t i o n w i
`the concept of stress-induced martensite and the effect
`t h e c o n c e p t o f s t r e s s - i n d u c e d m a r t e n s i t e a n d t h e e f f e c t
`a c h i e v a b l e by i t s u s e , a n d t h e n b y e x a m p l e s s h o w i n g how S I M
`achievable by its use, and then by examples showing how SIM
`a l l o y e l e m e n t s c a n b e s u b s t i t u t e d f o r c o n v e n t i o n a l SMA
`alloy elements can be substituted for conventional SMA
`elements in medical devices to achieve the beneficial effect
`e l e m e n t s i n m e d i c a l d e v i c e s t o a c h i e v e t h e b e n e f i c i a l e f f e c t
`o f t h e i n v e n t i o n .
`of the invention.
`
`The Figures illustrate the phenomenon of stress—
`The F i g u r e s i l l u s t r a t e t h e phenomenon o f s t r e s s -
`induced martensite by means of stress—strain curves.
`I n
`i n d u c e d m a r t e n s i t e b y means o f s t r e s s - s t r a i n c u r v e s .
`In
`both Figure 1 and Figure 2, the aiioy is at a temperature
`t h e a l l o y i s a t a
`t e m p e r a t u r e
`b o t h F i g u r e 1 a n d F i g u r e 2 ,
`between M
`and Md so that it is initially austenitic;
`b e t w e e n M s a n d M d s o t h a t i t i s i n i t i a l l y a u s t e n i t i c ;
`and it will be assumed for the puposes of this discussion
`a n d i t w i
` b e assumed
`f o r t h e p u p o s e s o f t h i s d i s c u s s i o n
`l
`l
`t h a t M s
`i s e q u a l t o M f , a n d A s e q u a l t o A f .
`F i g u r e
`that M is equal to Mf, and A3 equal to Af. Figure
`1 shows t h e c a s e when t h e t e m p e r a t u r e i s b e l o w A s ,
`1 shows the case when the temperature is below A5, so that
`s o t h a t
`a n y m a r t e n s i t e f o r m e d b y t h e a p p l i e d s t r e s s i s s t a b l e ; w h i l e
`any martensite formed by the applied stress is stable; while
`Figure 2 shows the case where the temperature is above A,
`F i g u r e 2 s h o w s t h e c a s e w h e r e t h e t e m p e r a t u r e i s a b o v e A
`S '
`so that austenite is the only stable phase at zero stress.
`t h a t a u s t e n i t e i s t h e o n l y s t a b l e p h a s e a t z e r o s t r e s s .
`s o
`
`In' F i g u r e 1, when a s t r e s s i s a p p l i e d t o t h e a l l o y ,
`In Figure 1, when a stress is applied to the alloy,
`A t
` a c r i t i c a l
`i t d e f o r m s e l a s t i c a l l y a l o n g t h e l i n e O A .
`it deforms elastically along the line OA. At a critical
`a p p l i e d s t r e s s , a M , t h e a u s t e n i t i c a l l o y b e g i n s t o t r a n s -
`applied stress, °M' the austenitic alloy begins to trans—
`form to (stress—induced) martensite. This transformation
`f o r m t o ( s t r e s s - i n d u c e d ) m a r t e n s i t e .
`T h i s t r a n s f o r m a t i o n
`
`10
`1 0
`
`15
`15
`
`20
`2 0
`
`25
`25
`
`COOK
`Exhibit 1003-0010
`
`

`

`57
`
`p
`
`,
`
`p
`
`/
`6PO884-’USl
`MP0884—USi
`
`—7—
`
`5
`
`10
`l o
`
`l 5
`15
`
`* O
`20
`
`25
`2 5
`
`takes place at essentially constant stress until the alloy
`t a k e s p l a c e a t e s s e n t i a l l y c o n s t a n t s t r e s s u n t i l t h e a l l o y
`From t h a t p o i n t on,
`becomes f u l l y m a r t e n s i , t i c a t p o i n t B .
`becomes fully martensitic at point B. From that point on,
`as further stress is applied, the martensite yields first
`a s f u r t h e r s t r e s s i s a p p l i e d ,
`t h e m a r t e n s i t e y i e l d s f i r s t
`elastically and then plastically (only elastic deformation
`e l a s t i c a l l y a n d t h e n p l a s t i c a l l y ( o n l y e l a s t i c d e f o r m a t i o n
`i s shown a t p o i n t C). When
`t h e s t r e s s is r e l e a s e d ,
`is shown at point C). When the stress is released, the
`t h e
`m a r t e n s i t e r e c o v e r s e l a s t i c a l l y t o p o i n t D , a t w h i c h t h e r e
`martensite recovers elastically to point D, at which there
`i s z e r o r e s i d u a l s t r e s s , b u t a n o n - z e r o r e s i d u a l s t r a i n .
`is zero residual stress, but a non—zero residual strain.
`Because the alloy is below A3, the deformation is not
`B e c a u s e t h e a l l o y i s b e l o w A s ,
`t h e d e f o r m a t i o n i s n o t
`r e c o v e r a b l e u n t i l h e a t i n g a b o v e A
`r e s u l t s i n a r e v e r s i o n
`recoverable until heating above A results in a reversion
`S
`A t
` t h a t p o i n t ,
`i f t h e s a m p l e i s u n r e s t r a i n e d ,
`to austenite. At that point, if the sample is unrestrained,
`t o a u s t e n i t e ,
`l
`l
` b e e s s e n t i a l l y c o m p l e t e l y r e c o v e r e d :
`t h e o r i g i n a l s h a p e w i
`the original shape will be essentially completely recovered:
`i f n o t , i t w i
`if not, it will be recovered to the extent permitted by the
`l
`l
` b e r e c o v e r e d t o t h e e x t e n t p e r m i t t e d b y t h e
`restraint. However, if the material is then allowed to
`i f t h e m a t e r i a l i s t h e n a l l o w e d t o
`r e s t r a i n t . H o w e v e r ,
`t o t h e o r i g i n a l t e m p e r a t u r e a t w h i c h i t was d e f o r m e d
`re—cool to the original temperature at which it was deformed
`r e - c o o l
`t e m p e r a t u r e w h e r e SIM b e h a v i o r o f t h i s t y p e i s s e e n ) ,
`( o r a
`(or a temperature where SIM behavior of this type is seen),
`the stress produced in the sample will be constant regardless
`t h e s t r e s s p r o d u c e d i n t h e sarnple w i
` b e c o n s t a n t r e g a r d l e s s
`l
`l
`of the strain provided that the strain lies within the
`o f t h e s t r