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`N TIIE UNITI9TATES PATENT AND ~ARK OFFICE
`I .\
`
`COMMISSIONER OF
`PATENTS AND TRADEMARKS
`Washington, D.C. 20231
`
`Sir:
`
`DOCKETN0.~94=3=8~-1=--~~­
`Prior Application:
`Examiner: D. Kenealy
`Group Art Unit: 3301
`
`This is a request for filing a ~ continuation D divisional application under 37 CFR § 1.60, of pending prior application:
`
`Serial No.: 07/956.653
`
`Filed: October 2. 1992
`
`Inventor: James E. Jervis
`
`For: MEDICAL DEVICES INCORPORATING SIM ALLOY ELEMENTS
`
`• 1. ~ Enclosed is a complete copy of the prior application, including the oath or declaration as originally filed and an
`af~davit or declaration verifying it as a true copy. (See 8 and 9 for drawing requirements.)
`
`2. D A verified statement to establish small entity status under 37 CFR 1.9 and 1.27 D is enclosed D was filed in the
`prior application and such status is still proper and desired (37 CFR 1.28(a)).
`
`3. D No additional fee is required or ~ the fee has been calculated as shown below:
`
`Column 1
`
`Column 2
`
`Column 3
`
`BASIC FEE
`
`TOT AL CLAIMS
`
`INDEPENDENT
`
`< 10
`
`,. 3
`
`MINUS**
`
`·•
`
`MINUS***·
`
`* = ,0
`0
`=
`*
`
`First presentation of multiple dependent claim
`
`::_:~ffi:giii
`?NorbSmfilE
`· gij~~tY ·
`$730
`
`x 22
`x 76
`
`+ 240
`
`$365
`
`$730, 00
`
`x 11
`x 38
`
`+ 120
`
`$
`
`$
`
`$
`
`TOTAL FEE$ 73o.oo
`- - - - - -
`If the entry in Column 1 is less than the entry of Column 2, write "O" in Column 3.
`If the number of Total Claims previously paid for is less than 20, write "20" in this sp~ce.
`If the number of Independent Claims previously paid for is less than 3, write "3" in this space.
`
`*
`**
`***
`
`4. ~ The Commissioner is hereby authorized to charge payment of any additional fees, in particular the following
`fees, associated with this communication, or credit any overpayment to Deposit Account No. 19-2090. A
`duplicate copy of this sheet is enclosed.
`
`5. ~ Enclosed is the fee of$ 730. 00
`
`by Check No. _s_ss_s ___ _
`
`6. D
`
`of the prior application before calculating the
`Cancel in this application original claims
`filing fee. (At least one original independent claim ~ust be retained for filing purposes.)
`
`7. D
`
`Amend the specification by inserting before the first line the sentence: - this is a D continuation, D division,
`of application Serial No.
`filed ____ _
`
`WPSl \PCJ \TEMP\9438-lC. APP
`
`Jun.
`
`7, 1995
`
`COOK
`Exhibit 1002-0001
`
`

`

`8·. rr-. T-~ansfer the drawings from.Jrior application to this application an.don said prior applications as of
`
`the filing date accorded this application. A duplicate copy of this sheet is enclosed for filing in the prior
`application file. (May only be used if signed by person authorized by § 1.138 and before payment of base
`issue fee.)
`
`9. D
`
`New formal drawings are enclosed.
`
`10.D
`
`Priority of application serial no. ______ , filed on _____ (date) in ___ __ (country) is claimed
`under 35 USC 119.
`
`11.D
`
`The prior application is assigned of record to - - - - - - - - - - - - - - - - - - - - -
`
`12. 181
`
`The power of attorney in the prior application is to Herbert G. Burkard. Reg. No. 24.500 and James W.
`Peterson. Reg. No. 26.057. An Associate Power of Attorney is to Jeffrey G. Sheldon. Reg. No. 27.953.
`Sheldon & Mak. 225 South Lake Avenue. 9th Fl.. Pasadena. CA 91101
`(name, registration number, address).
`
`a.
`
`b.
`
`c.
`
`181 The power appears in the original papers in the prior application.
`
`D Since the power does not appear in the original papers, a copy of the power in the prior application is
`enclosed.
`
`181 Address all future communications to Jeffrex G. Sheldon. Esq .. (818) 796-4000
`Sheldon & Mak. 225 South Lake Avenue. Suite 900. Pasadena. California 91101
`(May only-be completea-byapphcant, afto~ney or agent of record)
`
`13.181
`
`A preliminary amendment is enclosed.
`
`J4.181
`
`I hereby verify that the attached papers are a true copy of prior application Serial No. -'0""'7~/9""'5""'6::..i..:::;.:65::.:3:;....._ __ _ _
`as originally filed on _O=ct .... o"'"b .... er ...... 2='-'""19....,9""'2......_ _____ _
`
`The undersigned declares further that all statements made herein of his or her own knowledge are true and that all
`statements made on information and belief are believed to be true; and further that these statements were made with the
`knowledge that willful false statements and the like so made are punishable by fine or imprisonment, or both, m1der
`section 1001 of Title 18 of the United States Code and that such willful false statements may jeopardize the validity of
`the application or any patent issuing thereon.
`
`Date:
`
`225 South Lake A venue
`Suite 900
`Pasadena, California 91101
`(818) 796-4000 (213) 681-9000
`
`WPSl \PCJ\TEMP\9438-lC .APP
`
`::,ELDOJ'C/ Pn
`
`JEF~ SHELDON
`Reg. No.: =27'"""'"'95=3~-----
`
`181 Attorney or agent of record
`0 Filed under § l .34(a)
`
`'·
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`Jun. 7, 1995 A
`
`COOK
`Exhibit 1002-0002
`
`

`

`CERTIFICATE OF EXPRESS MAIL
`
`"EXPRESS MAIL" mailing label number RB638341759US
`Date of Deposit: June 7. 1995
`
`I hereby certify that:
`
`1.
`
`CONTINUATION PATENT APPLICATION ENTITLED "MEDICAL DEVICES
`INCORPORATING SIM ALLOY ELEMENTS" TRANSMITTAL SHEET
`
`2.
`
`PRELIMINARY AMENDMENT
`
`3. .
`
`COPY OF PRIOR APPLICATION SERIAL NO. 07/956,653 INCLUDING
`OATH/DECLARATION AND DRAWINGS.
`
`4.
`
`5.
`
`6.
`
`INFORMATION DISCLOSURE STATEMENT AND PT0-1449 FORMS (NO
`REFERENCES INCLUDED)
`
`CHECK NO. 5855 FOR $730.00 FILING FEE
`
`POSTCARD
`
`are being deposited· with the United States Postal Service "Express Mail Post Office to
`Addressee" service under 37 CPR 1.10 on the date indicated above and is addressed to the
`Commissioner of Patents and Trademarks, Washington, D.C. 20231.
`
`Marilyn C. Paik
`Typed or Printed Name of Person Mailing Paper or Fee
`
`COOK
`Exhibit 1002-0003
`
`

`

`T OF DRAWINGS
`p~RIGINALLY FILED
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`Exhibit 1002-0008
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`Exhibit 1002-0008
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`B~GROUND or THE
`
`INVENTION
`
`Field of the Invention
`
`MPOBBu-us1
`
`This invention relates to medical devices incorporating
`shape memory alloys, and to !mprovements therein.
`
`5
`
`Introduction to the Invention
`
`Materials, both organic and metallic, capable
`of possessing shape memory are well known. An article
`made of such materials can be deformed ·from an original,
`heat-stable configuration ~o a second, heat-unstable
`configuration. The article is said to have shape
`memor~ for the reason that, upon the application of
`heat alone, it can be caused to revert, or to attempt
`to revert, from its heat-unstable configuration to its
`ori.ginal, heat-stable configuration, i.e. it "remembers"
`its original shape.
`
`Among metallic alloys, the ability to possess shape
`memory is a result of the fact that the alloy undergoes
`a reversible transformation from an austenitic .state to
`a martensitic state with a ·change in temperature. This
`transformation is sometimes referred to as a thermoela~tic
`martensitic transformation. An article made from such an
`alloy, for example a hollow sleeve, is easily deforme~ from
`its ·original configuration to a new configuration when
`cooled below the temperature at which the alloy is trans-
`'
`formed from the austenitic state to the martensitic state.
`
`10
`
`25
`
`20
`
`25
`
`COOK
`Exhibit 1002-0009
`
`

`

`,.
`
`•
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`MP0884-US1
`
`The temperature at which this transformation begins is
`usually referred to as Ms and the temperature at which it
`finishes Mr. When an article thus deformed is warmed to
`the temperature at which the. alloy starts to revert back to
`austenite, referred to as As (Af being the temperature
`·at which the reversion i~ complete) the deformed object will
`begin to return to its original configuration.
`
`Many shape memory alloys (SMAs) are known to display
`stress-induced ~artensite (SIM). When an SMA sample ~xhibit­
`ing stress-induced martensite is stressed at a temperature
`above M
`(so that the austenitic state is initially
`s
`stabl~), but below Md (the maximum temperature at whicr
`martensite formation can occur even under stress) it first
`deforms elastically and then, at a critical stress, begins
`to transform by the formation of stress-induced martensite.
`Depending on whether the temperature is above or below A
`,
`s
`'
`th~ behavior when the deforming stress is released differs.
`If the temperature is below As' the stress-induced martensite
`is stable; but if the temperature is above A
`, the martensite
`.
`s
`is unstable and transforms back to austenite, with the
`sample returning (or attempting to return) to its original
`The effect is seen in almost all alloys ~hich
`shape.
`exhibit a thermoelastic martensitic transformation, along
`with the shape memory effect. However, the extent of the
`temperature range over which SIM is seen and the stress and
`strain ranges for the effect vary greatly with the allo~.
`
`In copending and commonly assignniJ.··a·s.Pf~~\'i8lf.l.1~~54s-;?67
`ation (Docket No. MPOB73-US1) to Quin, fhe disc~osure of
`which is incorporated herein by refefence, a nickel/titanium/
`vanadium alloy having SIM over a wide temperature range is
`disclosed.
`
`5
`
`10
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`15
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`20
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`COOK
`Exhibit 1002-0010
`
`

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`HP08Bt-US1
`
`5
`
`10
`
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`
`Shape memory alloys have found use in recent· years in,
`for example, pipe couplings (such as are described in U.S.
`Pat. Nos. 4,035,007 and 4,198,081 to Harrison and Jervis),
`electrical connectors (such as are described. in U.S. Pat. No
`3., 740,839 to Otte b. rischer), switches (such as are described
`in U.S. Patent No. 4,205,293), actuators, etc •
`.. ... --
`
`Various proposals have also been made to employ shape
`memory alloys in the medical field.
`ror example, U.S. Pat.
`No. 3,620,212 to Fannon et al. proposes the use of an SMA
`intrauterine contraceptive device, U.S. Pat. No. 3,786,806
`to Johnson et al. proposes the use of an SMA bone plate;
`J
`U.S. Pat. No. 3,890,977 to Wilson proposes the use of a~ SMA
`elemen~ to bend a catheter or cannula, etc.
`
`These medical SMA devices rely on the property of shape
`memory to achieve their desired effects. That is to say,
`they rely on the fact that when an SHA element is cooled to
`its martensitic state and is subsequently deformed, it will
`retain its new shape; but when it is warmed to its austenitic(cid:173)
`state, the original shape will be recovered.
`
`20
`
`However, the use of the shape memory effect in medical:
`applications is attended with two principal-disadvantages.
`First, it is difficult to control the transformation temp~r­
`atures of shape memory alloys with accuracy as they are
`usually extremely composition-sensitive, although various,
`t?chntques have been proposed (including the blending by
`?5
`~ J!:.rJ.R~ ~ta 11 u rg y of a lr ea dy-mad e alloys· of di ff e ri n_g tran~­
`see U.S. Pat. No. 4,310,354 to.
`fo rma ti on temperatures:
`Fountain et al.). Second, in many shape memory alloys there
`
`COOK
`Exhibit 1002-0011
`
`

`

`•
`
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`
`MP088l..-US1
`
`is a large hysteresis as the alloy is transformed between
`austenitic and martensitic states, so that reversing of the
`state of an SHA element may require a ~emperature excursion
`of several tens of degrees Celsius. The ·combination of these
`factors with.the limitation that (a) it is inconvenient to
`have to engage in any tem~era~ure manipulation, and (b)
`human tissue cannot be heated or cooled beyond certain
`relatively narrow limits (approximately 0° - 60°C for short
`periods) without suffering temporary or permanent damage is
`expected to limit the use that can be made of SMA medical
`devices. It would thus be desirable to develop a way in
`which the advant~geous property of shape memory alloys,
`I
`i.e. their ability to return to an original shape aft1r
`relatively substantial deformation, could be used in medical
`devices without requiring the delicacy of alloying coMtrol
`and/or the temperature control of placement or removal
`needed by present shape memory alloy devices.
`
`DESCRIPTION OF THE
`
`INVENTION
`
`Summarv of the Invention
`
`I have discovered thit if, in a medical device containing
`a shape memory alloy element which uses the shape memory
`property of that alloy, an element which shows the property
`of stress-induced .martensite is used instead, an improved dev_ice
`results.
`
`Accordingly, this invention provides a medical deyice
`intended for use within a mammalian body, or in such proximity
`to a mammalian body that the device is substantially at body
`temperature, which device comprises a shape memory alloy
`element, the improvement in.which comprises the substitiution
`of an alloy element which displays stress-induced martensite
`at said body temperature for the shape memory alloy element.
`
`5
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`20
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`25
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`30
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`COOK
`Exhibit 1002-0012
`
`

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`~:C'?>::h::i:~l::e w:~c:t:::~~:~:u:::s:::~e~::::~ versus
`
`Figures 1 and 2 illustrate the stress-strain behavior
`strain
`
`5
`
`Detailed Descriotion of the Preferred Embodiments
`. -
`
`The invention will be discussed first by introducing
`the concept of stress-induced martensite and the effect
`achie~able by its use, and then by examples showing how SlK
`alloy elements can be substituted for conventional SKA
`elements in medical devices to achieve the beneficial effEct
`of the invention.
`
`The Figures illustrate the phenomenon of stress-
`In
`induced martensite by means of stress-strain curves.
`both Figure 1 and Figure 2, the alloy is at a temperature
`between Hs and Md so that it is initially austenitic;
`and it will be assumed for the puposes of this dis=ussion
`Figure
`that Hs is equal to K,,
`shows the case when the temperature is below As' so tnat
`any· martensite formed by the applied stress is stable; while
`Figure 2 snows the case where ~he temperature is above A
`s '
`so that austenite is the only stable phase at zero stress.
`
`I
`
`In Figure 1, when a stress is appl·i~d to the alloy,
`it ~eforms elastically along the line DA. At a critical
`applied stress, cM, the austenitic alloy begins to trans-
`form to {stress-induced) martensite. This transformation
`
`10
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`COOK
`Exhibit 1002-0013
`
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`becomes fully martensitic at point 8.
`es further stress is applied, the martensite yields first
`elastically and then plastically (only elastic deformation
`is shown at point C). When the stress. is released, the
`martensite recovers elastically to point D, at which there
`is zero residual stress, but a non-zero residual Etrain.
`
`from ~hat point on,
`
`Because the alloy is below ~;; the deformation is not
`reco~erable until
`heating above As results in a re~ersion
`that point, if the sample is unrestrained,
`to austenite. At
`
`the original sh~pe will b~ essentially completely recovered:
`
`if not, it will be recovered to the extent permitted by the
`
`restraint. However, if the material is then allowed to
`re-cool to the original temperature at which it was deformed
`(or a temperature where SIM behavior of this type is jseen),
`the stress produced in t h'e sample w i 11 be constant regardless
`of the strain provided that the strain iies within tHe
`"p l ;; t e a u" reg i on of the s t res s - s~ r a i n c·u r v e .
`T h at i s ,
`a n d §A , t he s~7 ~e-~ w i 11 be 0 ._, •
`s t :r a i n b e t- w e e n c -
`T h i s
`~ A_~ ,.._
`can
`means that a known, constant force (calculable from::; M)
`be applied over a wide (up to 5~ or more for certain Ni/Ti
`though this resembles the
`alloys) strain range. Thus,
`conventional shape memory effect, because the alloy shows S!M
`
`for a
`
`l'I
`
`and is below A
`s
`
`a constant force can be achieved.
`
`!n Figure 2, when a stress is applied to the alloy,
`then by SIM alo~g line
`it deforms elastic&lly along line DA,
`A3, and by deformation. of the martensite to point C, just as
`in Figure 1. However, the stress-strain behavior on unloading
`is significantly diffe~ent, since the alloy is above As
`
`COOK
`Exhibit 1002-0014
`
`

`

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`5
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`end tne stsble phase is· therefo!-e austeni~~. As tne ~ress
`lo .D;
`is :-er.:ovec', :ne stlloy rtcove:rs t-lasticclly ·1'("t:r:. (
`then, at a critical stress, c:rA, the alloj rev~tt.S -to
`austeni:e ~ltnout reouiring a cnange in te;.pe~c~u~~.
`reversion occurs st essentially constant s~ress. rinally if
`the stress is removed from the reverted austenite, it
`recovers elastically along line EO.
`The recoverable deforffi-
`ation associated with the formation an~ reversion of stress(cid:173)
`
`induced martensite has been referred to as· pseudoelasticity.
`
`l.0
`
`While o H may be comparatively high, e.g. 50 ksi, cA is
`usually substantially lower .. ; --e.g. less than 10 ksi; thereby
`
`creating a constant-force spring with an effective working
`( c8 - ~). The shape change available
`range of about 5:;;
`i n
`t h u s me ch an i ca 11 y ,
`r a t h. er t ha n .. t h e rm a 11 y ,
`t h e S ':"A.
`i s
`
`15
`
`actuated and controlled, permitting a greater control over a
`
`device incorporating it ..
`
`I
`Suitable alloy for this invention i.e. those di~playin9
`stress-indu=ed ma~tensite at temperatures near mammalian
`
`body temperature (35°-~0°C), may .be selected from known SMAs
`bv those of ord~_na1~y skill in the\art, havino regard to this
`: . .
`. !
`-
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`disclosure by tstaRslfor the existen=e of the SIM effect at
`-
`,.....;_
`the desired ternpe:ratu~e. A particularly preferred 2110~ is
`~o( the ni=kel/titanium/vanadiurn alloY- ~ U.~. Patent Application
`Vi·?-G-&-7~--IJ.£-1-) ,r'lf) ~ f ~·~; e d ~ fl; ~?a~ t ~?
`~ t--1 o • 01-6 ~:11<' .f..._'1 ~ o •
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`The inventi~n will now be cisc~ssed in detail by some
`Examples of the use of an SIM alloy.
`
`25
`
`·'
`
`Exc:mole I.
`
`3C
`
`Akins, in U.S. Patent No. iJ,233,690, the disclost'.ire of
`~hich is incorporated herein by reference, describes the use
`of a shape memory alloy ring to· hold a sewing cuff to'the
`body of an artifical heart valve. The ring is made iR.the
`aus~enstic phase~ cooled to the rnartensitic phase, deformed,
`placed around the valve body, 2nd heated or allowed tQ warm
`to cause reversion to the austenitic phase and recovery of
`
`I
`
`~5
`
`the ring into engagement with the valve body.
`
`COOK
`Exhibit 1002-0015
`
`

`

`69
`
`•••
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`- 5-
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`• t-!P06oi.-USi
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`howeve:-, this technique has no: founc ::omme:-::ic.l
`acceptance. Present medical technique requires that the
`valve body be capable of being rotated relative to the cuff,
`thereby enabling the surgeon to set
`the rotational orientation
`of the valv~ after it has been sewn
`into place. This is
`because the techniques used make it difficult to
`
`desirable
`visualize
`or accomplish optimal orientation during initial
`placement.
`
`.J
`
`.5
`
`permit the desired rotation and yet ensure a
`
`In order to accomplish the desired torque control to
`firm hold of
`the cuff on the valve body, precise control of the pressure
`exerted on the valve body by the ring is needed. This is
`difficult because there are substantial manufacturi~g
`
`tolerances in the valve ~ody whi~h may be made, forlexample,
`of pyrolytic graphite or ceramics, etc. Because the austenite
`stress-strain curve is extremely steep, it is not c~nsidered
`pr·a'ctical to use the simple shape memory te::hnique proposed
`
`the. issue o f
`I n de e d , Aki n s does not e v en add:- es s
`by Akins.
`rotation.of the cuff with respe::t to the valve body.
`
`However, if an SIM alloy is used instead of conventional
`
`shape memory, the process may be considerably simplified.
`
`F~rst, if the alloy has a stress-strain curve like that
`of figu::-e 1
`the alloy ring may be made just as for Akins.
`
`The.ring is then expanded from its initial austenitic state
`by the formation of SIM. When the ring is placed about the
`
`valve body, it needs only to be heated above Af and'
`allowed to cool to its origi~al temperature for the ring to
`
`COOK
`Exhibit 1002-0016
`
`

`

`siO
`
`•
`
`• HP065~-US1
`
`engage ~he vaive body with 6 constant force, even : f the
`
`lhe
`valve body has a deviation from the specified size.
`torque may thus be controlled to the desired level despite
`manufacturing tolerances.
`
`5
`
`10
`
`15
`
`20
`
`Second, if the alloy has a stress-str~in curve like
`that of rigure 2,
`the ring may be expanded, placed over the
`valve body, and the stress ieleesed all at· the same temperature.
`
`Because the austenitic phase is stable, the stress-induced
`martensite spontaneously reverts to austenite until recovery
`is restrained by the ring engaging the valve body. Because
`
`the reversion to austenite takes place at constant stress, a
`constant foice (and henc~ constant torque) may be obtained
`regardless of manufacturing tolerances. Close tempefature
`contr~l is not required, either; and the fact that the
`patient in a heart valve replacement operation is convention(cid:173)
`ally cooled as much es 15°C or so below normal body temperature
`does· not affect the operation of the ring.
`
`To co~trol the torque at a sufficiently low level,
`it may be desirable for the alloy ring to be other than a
`solid ring, such as, for example, a con:inuous helical spring,
`a flat zigzag spring, et=. Such variations permit the
`achievement of a greater range of movement with cons:ant
`force and 2 reduction in the force exerted by the ring on
`the v2l~e body, since .the ring recovers in a bending~mode
`rather than in tension.
`
`COOK
`Exhibit 1002-0017
`
`

`

`•
`
`-11-
`
`•
`
`HP088t.-US1
`
`a11
`
`Examole II. Catheters And Cannulas
`
`. W i 1 s o n ,
`th e d i s c l o s u r e
`i n U .• S . P a t e n t No . 3 , 8 9 0 , 9 7 7 ,
`of which is incorporated herein by reference, discloses a
`catheter or cannula (both being included h~reinafter in the
`~ord 11 catheter") made of, .or containing, an SHA element to
`cause all or a portion of t~~~catheter to deploy in a useful
`form once introduced into a living body.
`
`However, again this device has not been commercialized.
`
`Possible defects of the device which have prevented commercial(cid:173)
`ization include (i) the inability to slowly emplace the
`catheter in a desired position when the transition teFperature
`of the alloy is below body temperature (since the SHA!
`element will attempt to revert to its original shape as it
`reaches body temperature), thus limiting the ability ~f the
`physician to place the device carefully and precisely; or
`alternatively, if the transition temperature of the 2lloyJ,.,i:
`above body temperature, the requirement that the device~
`.
`/Ci...
`heated to ~ temperature above body temperature to cause
`recovery and that the device be placed so as not to change
`shape again when it re-~ools (since the body temperature is
`below the transition temperature); (ii) the inability to
`remove the device easily~ and (iii) the need for controlled
`temperature storage to prevent prematur~ reversion to
`austenite of the SHA, with consequent shape change.
`
`The issue of removal of a catheter is especially.
`significant, and not addressed by Wilson. Consider, for
`example, a tracheal puncture catheter. This should b,e
`
`5
`
`10
`
`15
`
`20
`
`25
`
`0-
`
`COOK
`Exhibit 1002-0018
`
`

`

`a12
`
`-1 2-
`
`•
`
`MP088!.o-US1
`
`straight for easy insertion into the trachea through a
`puncture into the front of the neck, but should curve after
`insertion so that the flow of air or oxygen through the
`catheter passes axially down the trachea rather than impinging
`lf a shape
`on the surface of the trachea and damaging it.
`memory catheter is used as co~~~mplated by Wilson, it would
`presumably become austenitic and bend after insertion (see
`Figures 1a and 1b, and corresponding text, of Wilson). But
`removal would require either cooling to below the transition
`temperature (which could easily mean cooling to so low a
`temperature that the tracheal tissue is damaged), removal in
`the bent shape (presumably damaging tissue), or forcing:the
`austenitic SMA to straighten to permit direct removal (~nlikely
`I
`to be satisfactory since·the austenitic alloys e.g. of Ni/Ti
`may have yield strengths of 100 ksi or more, and force
`sufficient to cause plastic deformation would be required).
`
`0
`
`5
`
`If an SIM element is used instead, however, removal can
`be accomplished almost as easily as insertion.
`If the
`catheter is made in a bent shape (as in Wilson), it can be
`straightened by insertion of a st~aight pin down the catheter
`axis, the catheter deforming by the formation of stress-induced
`Insertion of the catheter ·into the trachea is
`martensite.
`accomplished while the 'catheter is straight, at whatever
`l. s ·de s i r e d ( p e rm i t t i n g e a s y a n d a c c u r a t e pl a c em e n t ) .;
`r a t e
`and the pin is gradually withdrawn to permit the catheter to
`take up its desired. shape as the martensite reverts to
`[It is assumed here that the stress-strain curve
`a u st e n i t e •
`
`of the alloy at the temperature of use-is of the form of .
`
`Figure 2, so spontaneous reversion occurs on removal· of the
`stress induced by t~e pin]~ When removal is desired, it ·may
`be achieved simply by the gradual insertion of the pin,
`straightening the catheter and permitting easy withdrawa~.
`
`~~· .. Insertion of the catheter into the body and pin removal may,
`
`___ « __ • •
`
`· - · - - . .
`
`of course, take place simultaneously if desired, as may pin
`f· reinsertion and removal of_ the catheter from the body.
`
`- - · · · · - - - - · · ·
`
`•
`
`• • • •
`
`COOK
`Exhibit 1002-0019
`
`

`

`al3
`
`•
`
`-13-
`
`Examole III.
`
`IUDS
`
`•
`
`HP0884-US1
`
`5
`
`10
`
`~5
`
`20
`
`!S
`
`Fannon et al., in U.S. Patent No. 3,620,212, the
`disclosure of which is incorporated herein by reference,
`discloses an intrauterine contraceptive device (an IUD)
`proposed to be formed of a shape memory alloy. The device
`is suggested to be deform~d in_the martensitic phase (the
`transition temperature being below the temperature of the
`uterus). and the deformed device insulated with, e.g .• wax
`and inserted.....a-t"'. Removal is contemplated only by using two
`SHA elements in opposition, the higher temperature one being
`martensitic ~t body temperature but st~ong enough so that,
`if heated, it will overcome the lGwer temperature element
`I
`and deform the IUD back to ·a removable shape. The hea~ing
`contemplated is electrical. The storage problem discussed
`in Example II also exists here, so that the device must be
`stored below its transition temperature.
`
`By the use of an SIH element, however, these dis(cid:173)
`advantages may be overcome. Again, assume that the· alloy is
`SIH psuedoelastic, i.e. that it has the stress-strain curve of
`Figure 2.· Then an IUD may be formed into the desired shape
`in the austenitic state, and deformed by compression into a
`tubular placement device (the deformation being such that
`the strain levels lie within the "p)ateau"· of the stress(cid:173)
`strain curve). When the placement device is inserted into
`the uterus, the IUD may be deployed by extrusion of the IUD
`from the placement device. Deployment is then controlle,d but
`immediate, so that the physician may satisfy himself with
`placement. Removal is the reversal of placement:
`the
`placement device is inserted into the uterus, the IUD deformed
`by withdrawal into the placement device, and the placem~nt
`device withdrawn. Temperature control is not required.
`
`--
`
`/
`
`COOK
`Exhibit 1002-0020
`
`

`

`a1u
`
`MP088L<-US1
`
`-14-
`
`Example IV. Bone Plates
`
`Johnson et al., in U.S. Patent No. 3,786,806, the
`disclosure of which is incorporated herein by reference,
`propose the use of Ni/Ti SMA bone plates in fracture
`fixation.
`The plate is deformed in its martensitic state,
`screwed to the two ends of the bone it is desired to compress
`together, and warmed (or alio-;,,.ed to warm)
`to the au.stenitic
`
`·.
`
`state, when the plate contracts, compressing the bone ends
`together.~
`IQL{ .
`Because of the high elastic moduli of the austenitic
`
`shape memory allo~,~t will be difficult to control ~he
`amount of force~ may be applied by a bone plate of the
`type proposed by Johnson et al., and precision placemJnt of
`the bone ends and elongation of the plate will be req~ired.
`
`If, however, an SIM pseudoelastic bone plate is used,
`it·will be easily possible to elongate the plate and fasten
`it to the bone ends without requiring high precision.
`Because of the comparatively large (e.g. 5%) ~train range
`at es~entially constant stress, the force which will be put
`on the bone ends to compress them will be readily adjustable
`(by the size of the plate, for example) and will be insensitive
`to precise placement of the bone ends and/or elongation of
`the plate. Also, the recovery of the plate, since it ~s
`controlled by mechanical restraint, may be as gradual as
`desired, achieving excellent force and time control, and
`permitting the surgeon to make adjustments as desired. '
`
`5
`
`10
`
`, -_,:,
`
`?O
`
`5
`
`COOK
`Exhibit 1002-0021
`
`

`

`r
`
`a15
`
`MP0884-US1
`
`-1.5-
`
`Examole V. Marrow Nails
`
`Baumgart et al., in U.S. Patent No. 4,170,990, the
`disclosure of which is incorporated herein by reference,
`discloses the use of the two-way shape memory effect (where
`an SHA element exhibits a first shape in ·the austenitic
`state and a second in the martensitic state, and spontaneously
`changes between ~he ~wo_\~ha~s with a change in temperature)
`\vY\"P \~"'\l.::>·11 u.~ S:aA.
`l .
`d
`1
`1
`.
`.
`t
`in, in er a ia, .martow nai s 1~~~1gures a through e, an
`- - /\_,,
`corr~sponding text, of Baumgart et al.)~
`a.~
`The method proposed, however, requires the use of a
`wide temperature range in order to cause the phase change
`which is the origin of the two-way shape memory eff~ct (.5°C
`to 60°C for the water used to cool or heat the nail b.
`In
`addition, it requires the manufacture of two-way shape
`memory elements, which is generally more complex than the
`manufacture of conventional shf\P.e memory elements; and
`~:s:· :t. C> tJ
`p r-e c i s e co n t r o l o f th e ....e-r a 1 Ii s } L i e Fl
`t em p e r a tu re i s
`r e qui r e d .
`"-
`However, if an SIM pseudoelastic alloy element is employed,
`these disadvantages may be overcome.
`may be gripped by an inserted tool, are provided within a
`marrow nail of the type shown in figure 1a of Baumgart et
`al., then the nail may be radially compressed· by the application·
`of stress by such a tool. When the nail is released by the
`tool, it will expand to fill the bone channel with a constant
`force (not readily available by Baumgart et al.); and it may
`be withdrawn by the reverse procedure.
`
`5
`
`15
`
`20
`
`25
`
`COOK
`Exhibit 1002-0022
`
`

`

`a16
`
`•
`
`-16-
`
`(xamole VI. Dental Arch Wire
`
`• MP088~-U51
`
`5
`
`10
`
`,.(cid:173)
`
`-~
`
`:o
`
`Andreasen, in U.S. Patent No. 4,037,324, the disclosure
`
`of which is incorporated herein by refe~ence, proposes the
`use of dental arch wires made of Ni/Ti aJloys instead of
`conventional 10-8 stainless steel wires.
`lhe wires are
`stated to be of lower elasti~ ~odulus and higher elastic
`limit than stainless steel, which is stated to be advantageous.
`Heat recovery of an SHA wire is also suggested as a technique
`for orthodonture.
`
`The technique o~ using the conventional shape memory
`effect is not believed to have found clinical applicatipn,
`
`\
`possibly because such a t~chnique would require rapid
`placement of the wire in its martensitic state to avoid
`premature recovery, and would result in rapid recovery with
`extremely high fo~ces, which would be painful for the patient.
`
`· The use of a wire which displays lower elastic modulus
`and hig~er elastic limit than stainle~s steel has found some
`application, however. Otsuka et al. in Metals forum, v. 4,
`pp. 142-52 (1981) have suggested that this behavior may be
`the result of elasticity enhanced by cold working and
`martensite-to-martensite psuedoelasticity in an al~oy which
`has a transition temperature below body temperature.
`The
`alloy, then, is martensitic rather than austenitic in it~
`undeformed s