United States Patent
`
`[19}
`
`[H]
`
`3,890,977
`
`Wilson
`1451 June 24, 1975
`
`[541
`
`I76]
`
`KINETIC MEMORY ELECTRODES,
`CATHETERS AND CANNULAE
`
`Inventor: Bruce C. Wilson, 34 Twickwood
`Ln.. Glens Falls, NY. 12801
`
`[22]
`
`Filed:
`
`Mar. 1, 1974
`
`[21 1 Appl. No: 447.340
`
`[52] US. Cl........ 128/418; [28/206 E; 128/DIG. 4;
`128/348; 128/350 R; 128/404; 128/418;
`128/419 P
`Int. Cl. ....................... Ablb 5/02; A61m 25/00
`Field of Search
`[28/418, 419 P, 404. 2.05 R.
`128/2.06 E. 21 E, 348. 349 R, 350 R, 351,
`D10. 4; 3/l.7; 75/170. 175.5
`
`[5l|
`[58]
`
`I 56]
`
`3.348.548
`3.419.010
`3.485.234
`3.558.369
`3.605.726
`3.606.592
`3.612.038
`
`References Cited
`UNITED STATES PATENTS
`10/1967 Chardack ........................ 128/419 P
`[2/1968 Williamson .................. 128/350 R
`
`Stevens ..................... 128/348
`| 2/1969
`1/1971 Wang ct a1 .............. 75/1755
`9/1971 Williams .................. 128/205 F
`9/1971 Madurski ct al ......................... 3/1 .7
`10/1971
`Halligan .........................
`l28/2.(]5 R
`
`
`
`3.664.347
`3.729.008
`
`5/1972
`4/1973
`
`Harrnjanz ........................ 128/419 P
`Berkovits ........................
`1 28/419 P
`
`Primary Examiner—Richard A. Gaudet
`Assistant Etaminer—Lee S. Cohen
`Attorney, Agent, or Firm—Cushman. Darby &
`Cushman
`
`{57]
`
`ABSTRACT
`
`A conductive electrode-catheter. biological catheter
`cannula or the like which is easily inserted into the
`body and which is efiectively anchored into a desired
`organ or tissue or properly located within a target cav-
`ity. The electrode. catheter. or the like incorporates a
`material. such as a known titanium-nickel alloy. hav‘
`ing heat~activated mechanical memory. The device is
`formed and annealed at high temperature into a shape
`for effective anchoring or proper location in an organ
`or other structure of the body. Then at a temperature
`below its transitional temperature it is reformed into a
`shape for ease of insertion. and when located in the
`desired organ or structure is heated above its transi-
`tional
`temperature,
`thereby returning to its original
`annealed anchoring or proper locating shape.
`
`15 Claims, 9 Drawing Figures
`
`
`
`Lombard Exhibit 1022, p. 1
`
`Lombard Exhibit 1022, p. 1
`
`

`

`E'l’Il’l/I 'l'l AVIV’ ” I‘ \V
`
` £0 __ A““““\\“““‘
`
`Lombard Exhibit 1022, p. 2
`
`Lombard Exhibit 1022, p. 2
`
`

`

`I
`KINETIC MEMORY ELECTRODES. CATHETERS
`ANI) CANNUIAE
`
`BACKGROUND OF THE INVENTION
`
`3,890,977
`
`2
`is inserted into the
`the like. After the electrode. etc..
`body and advanced into the target place. the material
`is heated to its transitional temperature thereby return-
`ing the material to its original shape.
`The titanium~nickel~cobalt alloy disclosed in US.
`Pat. No. 3.558.369 has the formula TiNi.,.Co,_.,. wherein
`Ti denotes titanium and constitutes approximately 50
`atomic ‘7: ofthe composition. and the term Ni,,Co.__,. de-
`notes nickel and cobalt respectively and make up the
`remaining approximately 50 atomic percent of the
`composition.
`.v is a factor which varies from greater
`than 0 to less than 1 whereby the relative percentage
`of nickel and cobalt varies inversely from less than [00
`percent to more than 0 percent. The transitional tem-
`perature of this alloy can be varied depending upon rel-
`ative composition from —396° to +33 l°F. Otherwise. it
`is essentially the same as the abovemcntioned titanium-
`nickel alloy.
`Once heated to its transitional temperature. the dc-
`vicc will thereafter maintain its original shape even
`when cooled below its transistional temperature. The
`electrode. catheter. or the like of the present invention
`is thus easy to operate. and can be readily designed to
`fit a wide variety of applications.
`OBJECTS OF THE INVENTION
`
`It is an object of the present invention to provide an
`improved electrode. catheter. cannula. or the like.
`It is another object ofthis invention to provide an im-
`proved electrode. catheter. or the like that is readily in~
`sertable yet on command effectively anchorable or
`properly locatable.
`It is a further object of this invention to fit an elec—
`trode. catheter. or the like with a transitional tempera-
`ture activated mechanical memory material.
`Other objects and advantages of the present inven-
`tion will become clear from the ensuing detailed de-
`scription of the invention.
`BRIEF DESCRIPTION OF THE DRAWINGS
`
`FIGS. Ia and lb are side elevational vieWs partly in
`section of the tip and part of the shaft portions of a
`catheter according to the present invention shown in its
`transition and reformed shapes respectively while FIG.
`It is a side view of the tip and part of the shaft of a
`modification ofthe catheter shown in FIGS. la and II);
`FIGS. 2a and 2/; are side views of a ventricular pacing
`electrode according to the present invention showing in
`phantom the location of the transitional temperature
`activated mechanical memory material in the shaft in
`both the transition and reformed shapes;
`FIGS. 3a and 3b are side views of an atrialventricular
`
`invention
`pacing electrode according to the present
`showing in phantom the location of transitional tem—
`perature activated mechanical memory material
`in
`both the shaft and tip portions in both the transition
`and reformed shapes;
`FIGS. 4a and 4/) are cross-sectional views taken along
`lines 4—4 of FIG. 2a showing alternative embodiments
`ofthe location ofthe transitional temperature activated
`mechanical memory material within the body of the
`electrode.
`
`DETAILED DESCRIPTION OF THE INVENTION
`
`A catheter formed according to the teachings of the
`present invention. shown generally at It) and having a
`shaft portion II and a tip portion l2. is disclosed in
`
`Lombard Exhibit 1022, p. 3
`
`to conductive electrode-
`invention relates
`This
`catheters. biological catheters. cannulae and the like.
`These devices are usually passed into and through a
`body orifice. incision. peripheral artery. vein. urogen-
`tial or respiratory passage. etc.. of an animal or human
`body and advanced until they reach a desired organ.
`structure. or cavity within the body. It has a long been
`a problem to provide such an electrode. cannula. or
`catheter that is readily inscrtable into the body and eas—
`ily advanced. while also being effectively anchorable
`into a desired organ or properly locatable within a tar
`get cavity. Effective anchoring is desirable in the case
`of a cardiac electrode to insure positive electrode
`contact with the endocardium (inner wall of the heart)
`whether a pacemaker an EKG recorder. or the like is
`connected to the electrode. In the case ofthe biological
`catheter or cannula. proper location and anchoring is
`desirable whether the catheter is used for drainage,
`pressure recording, gas administration. or for injection
`of medication. dye. etc.. into the cardiovascular. uro—
`genital. respiratory. lymph. or digestive systems. or into —
`other body parts.
`Various attempts have been made in the past to pro«
`vide electrodes or catheters which are readily insert—
`able while being effectively anchorable or properly lo-
`catable. US. Pat. Nos. 3.516.4l2. 3.348.548. and
`3.729.008 show cardiac electrodes that are mechani—
`cally held straight during insertion. and then are al-
`lowed to flex into another shape. while US. Pat. No.
`3.4l9.010 shows a catheter that is mechanically held
`straight and then allowed to curve to properly locate it
`in a cavity to provide drainage. While the prior art de—
`vices have been generally acceptable. they have been
`cumbersome to operate and do not allow for a wide va—
`riety ofdcsign modifications depending upon particular
`application.
`SUMMARY OF THE INVENTION
`
`II)
`
`I5
`
`20
`
`30
`
`35
`
`40
`
`The present invention provides an electrode. cathe—
`ter. or the like which is readily inscrtable while being
`effectively anchorable or properly locatable. These
`properties are provided by forming the device of the
`present in\ention. either wholly or in part. of a material
`exhibiting mechanical memory that
`is
`triggered by
`heat. Examples of such a material are the titanium«
`nickel alloy disclosed in US. Pat, Nos. 3.I74.85l and
`3.673.879. and the titanium-nickel-cobalt alloy dis-
`closed in US. Pat. No. 3.558.369. This first—mentioned
`alloy consists essentially of from 52—56% nickel by
`weight and correspondingly from about 48—44% tita-
`nium by weight. said alloy having the structure ofa sub
`stantially TiNi phase from about 500°C.
`to about
`—75f/(C. This material
`is originally formed with re-
`straint and by heat annealing (typically 950°—l.100°F.)
`into the shape desired once it is inserted into the body
`(such as a curve. angle. or any other of an infinite vari-
`ety of single or multiple configurations). Then the ma-
`terial
`is deformed at a temperature (typically room
`temperature] below its transitional temperature (from
`32°~33I°F depending upon relative composition. but
`typically from L)l'<°—l25"F) into a shape facilitating easy
`insertion into the body (such as a straight rod ). and the
`material is incorporated into the electrode. catheter. or
`
`45
`
`55
`
`bf)
`
`65
`
`Lombard Exhibit 1022, p. 3
`
`

`

`3,890,977
`
`3
`FIGS. Ia and 1h, The catheter has a tubular body 13.
`preferably formed of plastic. silastic. rubber. or similar
`material. and a lumen 14. Fluid contained in lumen I4
`can be injected through holes IS into a body part. or
`fluid can be drained from a body cavity or structure
`through holes 15 and lumen 14. Liquid coupled pres—
`sure recordings can also be made by attaching trans~
`ducers or similar diagnostic equipment to liuid filled
`lumen I4.
`A rod 16 of transitional temperature activated me-
`chanical memory material is incorporated into the tip
`portion of the catheter, The rod l6 can either be di»
`rcctly incorporated into a portion of the body 13. or it
`can be affixed thereto. FIG. Ia shows the rod in a typi-
`cal shape for properly locating the catheter within a
`particular body part. The rod is originally annealed into
`this shape before incorporation into the catheter. and
`then assumes this shape again after cooling and subse—
`quent heating to its transitional temperature (typically
`98°—125°Ft. FIG.
`II) shows the rod in a shape for easy
`insertion and advancement into the desired body cay-
`ity. This is the reformed shape of the rod.
`In operation. the rod 16 is formed into its properly
`locating shape—such as shown in FIG.
`lu—and is
`cooled down below its transitional temperature. The
`composition of the rod is preferably selected so that
`this transitional temperature is 98°— l 25"F, and the rod
`is cooled down to room temperature. Then the rod
`is reformed into a shape for ease of insertion into the
`body such as shown in FIG. lb—and is incorporated
`into the catheter body 13. Then the catheter is inserted
`into the body and advanced to the desired location.
`whereupon the rod 16 is heated above its transitional
`temperature. The heating can be done by any suitable
`means, one form of applying heat being the body heat
`itself. Where body heat is relied upon, it is obvious
`that the composition of the transitional temperature
`activated mechanical memory material must be
`selected so that it has a transitional temperature at
`or just below body temperature. Heating causes the
`rod 16 to assume its original shape— FIGS. la thereby
`properly locating the catheter 10.
`FIGS. 2—4 show electrodes formed according to the
`teachings ofthe present invention. In FIG. 2a a ventric-
`ular pacing electrode shown generally at 20 is dis-
`closed. The electrode has a shaft portion 21 and a tip
`portion 22. Conductive portions 23. 24 are connected
`to a source of current or to monitoring devices. The
`body portion 26 is formed of a flexible non<conductive
`material such as plastic. silastic. or a high medical
`grade durameter rubber. A rod 25 of transitional tern-
`perature activated mechanical memory material incor-
`porated into shaft portion 21 is shown in phantom in
`FIGS.
`21.! and 2h. FIG 211 shows the rod in a typical
`shape for ease of insertion and advancement of the
`electrode into the proper body location. while FIG. 2/7
`shows the rod in a shape for effective anchoring of the
`electrode into a body organ. Effective anchoring is de«
`sirable in the case ofa cardiac electrode to insure posi-
`tive electrode contact with the endocardium.
`FIGS. 3a and 3!) show an example of an atrialyen»
`tricular pacing electrode having transitional tempera-
`ture activated mechanical memory material rods 25
`and 25' incorporated in both the shaft portion 2| and
`the tip portion 22 of the electrode. The electrode has
`two sets of conductive portion. 23. 24 and 23'. 24'.
`FIG. 31') shows the electrode in a typical proper anchor.
`
`'Ji
`
`ll)
`
`| 5
`
`20
`
`3o
`
`35
`
`40
`
`5t)
`
`55
`
`oil
`
`(is
`
`4
`
`ing configuration. \\hile FIG. 3a shows the rods in typi—
`cal reformed shapes for ease of insertion of the elec-
`trode into a desired portion of a body,
`FIGS. 4a and 4/) show alternative embodiments ofthe
`location of the rod 25 in the electrode body 26. Con—
`ductors 27. 28 are leads from electrodes 23. 24 to a
`source of current such as an implantable or external
`cardiac stimulus generator (pacemaker). or to moni-
`toring diagnostic or sensing devices such as EKG. HIS
`bundle recorders. oscilliscopes. etc. In FIG. 4a the rod
`25 is incorporated in electrode body 26 spaced from
`the conductors 27. 28, while in FIG. 4b the conductors
`27. 28 are hollow. and the rod (or rodsJ is incorporated
`within the hollow of one of the conductors (or both of
`them).
`It
`is obvious that many modifications of the present
`invention are possible. For instance.
`the transitional
`temperature activated mechanical memory material
`may be constructed in forms other than a rod. The tran-
`sitional temperature activated mechanical memory ma—
`terial may be formed into a braid [6' which could over-
`lay the catheter body. or be incorporated into the wall
`or solid cross—section by melting or extruding the body
`(see FIG. Ic) material around the braid. Similarly it
`couid be in the form of a tube surrounding the outside
`diameter of the catheter. or a tube incorporated within
`the catheter body. or a helical wrap around the outside
`diameter or incorporated within the catheter body. The
`transitional material may also comprise a whole portion
`of the catheter or like device. or may extend through-
`out the whole length or any portion thereof. The con—
`ductors themselves. or some part
`thereof. could be
`formed from the transitional material.
`
`The possible methods utilizable to heat the transi—
`tional temperature activated mechanical memory ma»
`terial to its transitional temperature after proper inser-
`tion and advancement are numerous,
`In addition to
`merely utilizing body heat. heating could be accom—
`plished by electrical induction heating or liquid immer-
`son or injection. For electrical induction heating. an
`electrical current from a specially designed current
`generator is fed to the transitional material. Injection
`into the catheter or immersion of the transitional mate-
`rial in a heated or cryogenically cooled liquid to either
`heat up the material above its transitional temperature.
`or to cool the material below its transitional tempera-
`ture and after proper location discontinue cooling
`thereby allowing body heat to heat it above its transi-
`tional temperature. are also contemplated.
`Other transitional temperature activated mechanical
`memory materials could be utilized besides the above
`mentioned titanium—nickel and titanium-nickel-cobalt
`
`alloys. The above-mentioned alloys are especially ad-
`vantageous. however. since the anneal. reform, and re»
`vision state cycle may be repeated indefinitely as long
`as the original annealed temperature is not exceeded.
`and since in returning to its original shape it is capable
`of exerting considerable force (recovery stresses of
`I [0.000 psi have been measured on an 0.020 inch di-
`ameter wire as it attempted to return to its remembered
`state I.
`
`Although preferred embodiments. uses. and modifi-
`cations of the invention have been depicted and dis—
`closed. such description is to be considered illustrative
`rather than limiting. for the invention may be variously
`modified. and is to be limited in scope only by con-
`struction of the following claims.
`
`Lombard Exhibit 1022, p. 4
`
`Lombard Exhibit 1022, p. 4
`
`

`

`
`
`3,890,977
`
`5
`
`What is claimed is:
`l. A catheter comprising
`a. an elongated generally cylindrical body member
`having a proximate and a distal end. said distal end
`for insertion into a body.
`b. a distal portion of said body member capable ofas-
`suming a shape for ready insertion into a body, and
`a different shape for proper location in a body. and
`c. means for shifting said distal portion from said
`readily insertable shape to said different properly
`locating shape upon bringing said portion to a spec-
`ified temperature. said means comprising at least a
`portion of transitional temperature activated mc«
`chanical memory material formed into said distal
`portion.
`2. A catheter as recited in claim 1 wherein said body
`member is formed of flexible non-conductive material
`having at
`least one section of conductive material
`formed on the exterior of a distal portion thereof and
`an interior section of conductive material leading from
`said exterior conductive material section to the proxi-
`mate end ol‘ said body member. whereby the catheter
`functions as an electrodecatheter.
`3. A catheter as recited in claim 2 wherein said inte—
`rior of conductive material is hollow. and wherein said
`portion of transitional temperature activated mechani—
`cal memory material comprises a rod encompassed by
`said section of hollow conductive material.
`4. A catheter as recited in claim 2 wherein said inte—
`rior section of conductive material comprises in part
`said transitional
`temperature activated mechanical
`memory material.
`5. A catheter as recited in claim I wherein said body
`member is formed of flexible non—conductive material
`and has an internal cavity extending substantially
`throughout the length thereof. and at least one passage
`formed in the distal end ofthe body member communi»
`eating from the exterior thereof to said internal cavity.
`6. A catheter as recited in claim 5 wherein said por-
`tion of transitional temperature activated mechanical
`memory material is in the form of a braid in engage-
`ment with the distal portion of said body member.
`7. A catheter as recited in claim 5 wherein said por—
`tion of transitional temperature activated mechanical
`memory material is in the form of a rod.
`8. A catheter as recited in claim I wherein said shape
`for ready insertion is a straight shape. and wherein said
`shape for proper location is a curved shape.
`9. A catheter as recited in claim 1 wherein said tran—
`sitional temperature activated mechanical memory ma-
`terial is an alloy consisting essentially of from 52-56%
`nickel by weight and correspondingly from about
`
`6
`48-44% titanium by weight.
`I0. A catheter as recited in claim 1 wherein said tran—
`
`sitional temperature activated mechanical memory ma-
`terial is an alloy having the formula
`
`wherein
`
`TiNiJCo ,._,»
`
`l0
`
`2()
`
`Id '.1\
`
`3t}
`
`4t)
`
`Ti denotes titanium and constitutes approximately 50
`atomic percent of the composition and the term
`NirCoH denotes nickel and cobalt respectively and
`make up the remaining approximately 50 atomic
`percent of the composition. and .r is a factor which
`varies from greater than 0 to less than I whereby
`the relative percentage of nickel and cobalt varies
`inversely from less than 100 percent to more than
`0 percent with respect to each other on an atom for
`atom exchange basis.
`H. The method of properly locating a catheter in a
`body structure within a body comprising the steps of
`a. forming a member oftransitional temperature acti-
`vated mechanical memory material
`into a first
`shape.
`incorporating said member into a portion of a
`catheter.
`c. forming said catheter portion into a second shape
`for ease of insertion into the body and advance-
`ment of said catheter to the body structure.
`(I. inserting the catheter into the body and advancing
`said catheter to the body structure.
`e. heating said catheter portion to a specified temper
`ature whereby said catheter portion will revert to
`said first shape and will thereby assume a shape for
`proper location of the catheter within the body
`structure,
`
`b.
`
`12. The method of claim 11 comprising the further
`step of immersing said portion of the catheter into a
`cooling fluid until the catheter has been inserted into
`the body and advanced to the body structure.
`13. The method of claim 11 wherein said heating is
`accomplished by passing an electrical current through
`said transitional
`temperature activated mechanical
`memory material member of the catheter.
`l4. The method of claim 11 wherein said heating is
`accomplished by immersing said portion ofthe catheter
`into a heating fluid.
`15. The method as recited in claim It wherein said
`
`specified temperature is body temperature or slightly
`less than body temperature. and wherein the body ac-
`complishes said heating,
`
`50
`
`(3”
`
`h5
`
`
`
`Lombard Exhibit 1022, p. 5
`
`Lombard Exhibit 1022, p. 5
`
`