DE 198 57 887 A1
`
`(19)
`
`(12) Unexamined patent specification
` FEDERAL
` REPUBLIC (10) DE 198 57 887 A1
` OF GERMANY
`
`(51) Intl. Cl.7:
`A 61 F 2/24
`A 61 F 2/02
`
`(21) References:
`(22) Application date:
` (43) Publication date:
`
`198 57 887.3
`15 Dec 1998
`6 Jul 2000
`
`GERMAN
` PATENT AND
`TRADEMARK OFFICE
`_________________________________________________________________________________
`
`(71) Applicant:
`Fraunhofer Corporation for the Advancement of
`Applied Research e.V., Munich, Germany (DE) 80636;
`Figulla, Hans-Reiner, Prof., MD, Jena, DE 07743;
`Ferrari, Markus, MD, D. Disc.Pol., Jena, DE 07747;
`Lang, Klaus, MD, Cospeda, DE 07751
`
`(74) Representative:
`PFENNING MEINIG & PARTNER, Dresden 01217
`
`(72) Inventor:
` Weber, Carsten, Engr., Jena, DE 07743; Damm,
` Christoph, Engr., Jena, DE 07743; Figulla, Hans-
` Reiner, Prof., MD, Jena, DE 07743; Ferrari, Markus,
` MD, Dr.Disc.Pol., Jena, DE 07747; Lang, Klaus, MD,
` Cospeda, DE 07751
`
`(56) Citations:
`
`DE
`DE
`US
`US
`US
`
`195 32 846 A1
`4,316,971 A1
`5,855,601 A
`5,540,712 A
`5,411,552 A
`
`__________________________________________________________________________________
`The following information was extracted from documents submitted by the applicant
`Examination request is provided in acc. with §44 of the Patent Act (PatG)
`
`(54) Anchoring support for a heart-valve prosthesis and a method for its manufacture
`(57) The invention concerns an anchoring support for a heart-valve prosthesis and a method for its
` manufacture. A shape-memory metal is used for the anchoring support (stent), with which the
` anchoring support together with a heart-valve prosthesis will be achieved, without performing
` serious operational intervention, through the aorta as far as the immediate vicinity of the heart
` and can be implanted there. According to the invention, the anchoring support for this is
` formed as a one-part body, which is made of rod-shaped elements that represent at least
` partially a lattice structure.
`
`NORRED EXHIBIT 2126 - Page 1
`Medtronic, Inc., Medtronic Vascular, Inc.,
`& Medtronic Corevalve, LLC
`v. Troy R. Norred, M.D.
`Case IPR2014-00110
`
` FEDERAL PRINTING HOUSE May 2000 002 027/57/1 14
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`DE 198 57 887 A1
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` Description
`The invention concerns an anchoring support (stent) for a heart-valve prosthesis, as well as a
`method for its manufacture, in which a shape-memory metal, also called a memory metal, is used in
`order to implant a heart-valve prosthesis without having to perform serious operational intervention
`with a complete opening of the thorax.
`So, among other things, for example, it is known from DE 195 46 692 A1 to introduce a self-
`expanding heart-valve prosthesis with an anchoring support by means of a heart catheter system
`without opening the thorax through the opened aorta in the groin of a person and reaching the desired
`location, to position it in the vicinity of the heart, preferably in the region of the original heart valve,
`and to install it firmly there by self-expansion.
`However, it has been shown that the principle of the solution indicated there to date cannot
`be practicably employed. Up to now, no way has been shown whereby an anchoring support for a
`heart-valve prosthesis could be folded up once into so small a state that it could be guided together
`with a catheter through the aorta and here, in particular, through the curve of the aorta to the heart.
`But such an anchoring support has additionally to be in a position in a second state to attain a size
`and shape with which it is ensured that the heart-valve function can be ensured for a sufficiently long
`time.
`
`The proposal that can be drawn from DE 43 16 971 A1 has also been proven not to be
`practicable. A shape-memory material is to be used there that can be rolled up or widened at the
`replacement location. The carrier designated there as a heart-valve anchoring ring for an artificial
`heart valve is to be in a rolled-up state, as already stated, guided by means of a catheter to the heart
`and is applied there to the inside wall of the aorta upon heating due to the coiling of the anchoring
`ring, whereby an anchoring means is additionally made available for anchoring using an anchoring
`ring projecting outward.
`This solution also could not be practicably used up to now because the helically coiled body
`still has too large a diameter to be able to be guided through the aorta to the heart with no problems.
`In addition, a corresponding device must be positioned extremely precisely when it is placed in the
`vicinity of the heart, because the openings of the coronary vessels should in no way be closed.
`In addition, the solution proposed there has proven to be problematic regarding the increase
`in the danger of thrombosis.
`Also, the use of balloon catheters for the application targeted here has shown no satisfactory
`results up to now, and so the system described in WO 91/17720 A1 cannot be used in practice either.
`At the same time, an element made of a plurality of metal wires placed together and curved is used,
`onto which a heart-valve prosthesis can be fastened and the balloon present with it on the catheter is
`mechanically stretched. The size required for this, however, is not sufficient for the spatial
`conditions actually existing in the aorta, and so a, appropriate operational intervention has not been
`able to be performed with success to date.
`It is therefore a task of the invention to offer an anchoring support for a heart-valve prosthesis
`that is simple to manufacture and with which it is moved into a position to guide it together with a
`heart-valve prosthesis through the aorta as far as the immediate vicinity of the heart and there to
`implant it successfully.
`According to the invention, this problem is solved with the features of patent claim 1 for the
`anchoring support and in the features of claim 12 for a method for manufacturing a corresponding
`anchoring support. Advantageous embodiments and further developments of the invention result
`from the features cited in the subordinate claims.
`At the same time, the solution according to the invention derives from the known concept of
`using a shape-memory material and it is therefore proposed to use an anchoring support made of
`shape-memory metal, which can assume a stampable shape and size upon reaching a specific pre-
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`determinable transition temperature, which makes possible a secure hold, tightness of the heart-valve
`prosthesis, low danger of thrombosis, and the consideration of leaving the coronary vessel openings
`open. The anchoring support for a heart-valve prosthesis according to the invention is therefore
`constructed as a one-part body, which is shaped out of individual rod-shaped elements, which
`represent at least partially a lattice structure.
`What is more, the thickness of the rod-shaped elements is selected to be as small as possible
`in order to ensure at one time sufficient strength and stability and for another thing to still
`accordingly keep the danger of thrombosis low. Therefore, the thickness of the rod-shaped elements
`in the area is between 0.3 and a maximum of 1 mm.
`Thus it can be ensured that the body manufactured from a semi-finished product that consists
`of a shape-memory metal, can be pressed together or folded very small, for another thing, which
`upon positioning the body pressed or folded together can be reliably held through the aorta not to
`exceed a free cross-section of about 7 mm.
`According to the invention, the anchoring support is manufactured out of a semi-finished
`product consisting of shape-memory metal, in which the structure proper with the rod-shaped
`elements is cut out or stamped out. A laser-cutting method is especially preferably imagined for
`cutting it out, with which it is moved into a position for the desired structure to be constructed very
`precisely and exactly in the relatively low wall thickness.
`After the desired structure is constructed, the anchoring support is brought to the desired
`shape and size for the implanted state and at the same time, is stamped during heat treatment, taking
`into consideration the transition temperature to be employed, which will advantageously be in the
`range of about 37°C.
`As a semi-finished product, a correspondingly constructed plate-shaped element, but
`preferably a tubular semi-finished product, can be used. For the case in which a plate-shaped
`element is used, this must not only be widened for stamping the desired shape and size, but also be
`correspondingly curved, at least approximately into a circular shape.
`After stamping the shape and size of the anchoring support according to the invention, the
`heart-valve prosthesis can be fastened onto it. The heart-valve prosthesis can be pulled onto the
`anchoring support from the outside of one side and if necessary additionally sewn onto it, whereby
`this part of the anchoring support is shaped and sized so that the commissures of a biological heart-
`valve prosthesis are taken into account, which, for example, can be removed from a swine heart and
`be made available in a prepared shape. But such a heart-valve prosthesis can also be guided by the
`anchoring support and be fastened from the inside onto the correspondingly constructed lattice
`structure or curved element. In a similar manner, an artificial heart-valve prosthesis made of suitable
`material can also be used for this.
`A nickel-titanium alloy can be used as a shape-memory metal, which is, for example,
`obtainable commercially under the name of Nitinol. After building the structure and stamping the
`desired shape and size in the implanted state, the anchoring support can be improved and smoothed
`by a known surface-treatment method, such as electropolishing for instance, so that the danger of
`thrombosis can thereby be counteracted.
`With the anchoring support according to the invention, a lattice structure is built in which the
`rod-shaped elements are constructed as meandering in part, and in their alignment form at least one
`support ring, which can be placed as such in the implanted state on the inner wall of the aorta. But
`on the one or on a plurality of such support rings formed with rod-shaped elements, anchoring barbs
`can be constructed, which also consist of the shape-memory metal used. These anchoring barbs are
`adjusted, however, during stamping, to a position aligned radially outward, so that they are hooked in
`the implanted state in the inner wall of the aorta and the anchoring support can be accordingly be
`held securely and the hooking can additionally act as a tensile force for the expanded anchoring
`support.
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`It is advantageous if the anchoring barbs are stamped in different alignments, which
`respectively lie in opposite directions relative to the longitudinal axis at an angle not equal to 90°, so
`that secure anchoring in both possible directions of anchoring-support movement can be achieved.
`The anchoring barbs should exhibit a length of at least 1 mm and a maximum of 5 mm, so that
`complete transection of the inner aorta wall can be avoided.
`If an anchoring support is used with more than one support ring, these support rings can be
`achieved by means of connecting pins between meanders disposed beside one another, which
`meanders are formed by the rod-shaped elements of the support ring.
`The heart-valve prosthesis can be in contact with a closed circular ring disposed on the front
`side or on a ring formed from a polygon.
`But the option also exists of constructing on this front side of the anchoring support three
`curved elements for fastening the heart-valve prosthesis. At the same time, these curved elements are
`in contact in the implanted state on the inner wall of the aorta. With the curved elements, greater
`elasticity is attained compared to a closed ring, upon self-expansion and at the same time an
`adjustment to the shape of the commissures of a heart-valve prosthesis.
`Besides a tubular shape, the anchoring support according to the invention can also be
`constructed in the form of a polygon, whereby it makes at least eight corners available. The last-
`mentioned shape has an increased self-latching effect, because the corner edges and the rod-shaped
`elements used for connecting a plurality of support rings cannot be aligned parallel to the
`longitudinal axis of the anchoring support. Hence an increased shape-protection can be attained to
`securely hold the anchoring support in the aorta.
`After fastening the heart-valve prosthesis to the anchoring support according to the invention,
`the two of them are pressed or folded together and are accommodated in a pocket, which is fastened
`to a catheter. At the same time, the pocket is connected to a cooling system, through which an
`accordingly cooled salt solution is conducted, so that the anchoring support is kept below the
`transition temperature.
`The catheter can then be guided in a known shape on a wire through the aorta up to the
`immediate vicinity of the heart. After reaching the desired position and checking the position
`relative to the coronary-vessel openings, the protective cap can be removed or destroyed and upon
`reaching the transition temperature, is set in the desired shape and size for the implantation of the
`anchoring support due to the self-expansion, whereby, at the same time, the anchoring barbs are
`aligned and clamp onto the inner wall of the aorta.
`Finally, the guide wire and catheter can be removed again and the heart-valve prosthesis
`assumes the function of the natural heart.
`The invention will be explained in detail by way of example in the following, using
`embodiment examples.
`Thus they show:
`Fig. 1, an example of an anchoring support according to the invention, with a heart-valve
`prosthesis in an implanted shape and size and
`Fig. 2, a lattice structure of an example of an anchoring support in a development view.
`In the example shown in Fig. 1, the anchoring support offers two saw-tooth–shaped support
`rings 6 formed from rod-shaped elements 4, which are connected to one another with connecting pins
`3.
`In addition, a sealing and fastening ring 1 for the heart-valve prosthesis 2, which exhibits a
`circular shape here, is available, as well as further rod-shaped elements, which represent the
`connection to the support rings 6 and take into account the shape and size of the commissures of the
`heart-valve prosthesis.
`In addition, additional anchoring barbs 5 are available on the support rings 6 which, as has
`already been stated in the general part of the description, are aligned radially outward upon
`exceeding the pre-determined transition temperature during stamping.
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`In the example shown in Fig. 2 of an anchoring support according to the invention, the
`presentation of a development is selected in order to be able to more clearly recognize the structure
`constructed in the shape-memory metal. In this example, in turn, two support rings 6, are selected
`using a saw-toothed construction for the rod-shaped elements 4, on which, in turn, anchoring barbs 5
`are available. Both of the support rings 6 are connected as well to connecting pins 3, which are
`partially curved away, loop-like, for a required variable length, if necessary.
`In the area of the anchoring support, on which the heart-valve prosthesis will be positioned
`and affixed, three curved elements 7 are constructed in this example, with which the heart-valve
`prosthesis can be in contact and be fastened. The shape of the curved elements 7 takes into account
`the shape and size of the commissures of a biological heart-valve prosthesis.
`
` Claims
`1. A anchoring support for a heart-valve prosthesis, which is formed from a shape-memory metal
`assuming a specific shape at a pre-determined temperature, characterized in that the anchoring
`support is a one-part body, which is formed out of rod-shaped elements (1, 3, 4, 5), which represent
`at least partially a lattice structure.
`2. The anchoring support according to claim 1, characterized in that the rod-shaped elements (4) are
`constructed saw-toothed and form at least one support ring (6).
`3. The anchoring support according to claim 1 or 2, characterized in that anchoring barbs (5), which
`are aligned radially outward upon reaching the transition temperature of the shape-memory metal, are
`on the support ring(s) (6).
`4. The anchoring support according to one of claims 1 through 3, characterized in that the anchoring
`barbs (5) exhibit a length of at least 1 mm.
`5. The anchoring support according to one of claims 1 through 4, characterized in that the anchoring
`barbs (5), which are aligned radially outward relative to the longitudinal axis of the anchoring
`support in opposite directions, are at an angle not equal to 90°.
`6. The anchoring support according to one of claims 1 through 5, characterized in that the support
`rings (6) are connected by means of connecting pins (3).
`7. The anchoring support according to claims 1 through 6, characterized in that on the side on which
`the heart-valve prosthesis is affixed, three curved elements (7) are constructed for affixing the heart-
`valve prosthesis (2), which are in contact with the inner wall of the aorta.
`8. The anchoring support according to one of claims 1 through 7, characterized in that all the
`elements (1, 3, 4, 5) exhibit a width/diameter of 1 mm maximum.
`9. The anchoring support according to one of claims 1 through 8, characterized in that the lattice
`structure is constructed taking into consideration the size and position of the coronary vessel
`openings.
`10. The anchoring support according to one of claims 1 through 9, characterized in that the anchoring
`support(s) is(are) disposed within a cooled pocket on a catheter during positioning through the aorta.
`11. The anchoring support according to one of claims 1 through 10, characterized in that the support
`ring(s) (6) is(are) constructed like a polygon, with at least eight corners.
`12. A method for manufacturing an anchoring support according to one of claims 1 through 11,
`characterized in that
`- a lattice structure with rod-shaped elements (1, 3, 4, 5) is constructed in a semi-finished
`product made of shape-memory metal;
`- the anchoring support in the desired shape and size is brought into an implanted position and
` this is stamped to the shape-memory metal during heat treatment, taking into consideration
` the transition temperature.
`13. The method according to claim 12, characterized in that the lattice structure is constructed by
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`means of a laser-cutting method.
`14. The method according the claim 12 or 13, characterized in that a tubular, semi-finished product
`made out of a shape-memory metal is used.
`15. The method according to one of claims 12 through 14, characterized in that a semi-finished
`product is used whose wall thickness exhibits the thickness of the rod-shaped elements (1, 3, 4, 5).
`16. The method according to one of claims 12 through 15, characterized in that the stamping of the
`shape and size of the anchoring support is executed for a transition temperature of about 37°C.
`17. The method according to one of claims 12 through 16, characterized in that a nickel-titanium
`alloy is used.
`18. The method according to one of claims 12 through 17, characterized in that the anchoring
`support is subjected to a surface treatment by means of electropolishing.
`________________________
`Herewith 2 pages of drawings
`________________________
`
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`DRAWINGS PAGE 1
`
` DE 198 57 887 A1
` Number:
` Intl. cl.7:
` A61 F 2/24
` Publication date: 6 July 2000
`
`7
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`002 027/57
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` DE 198 57 887 A1
` Number:
` Intl. Cl.7:
` A 61 F 2/24
` Publication date: 6 July 2000
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`Fig. 2
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`July 30, 2013
`
`Certification
`
`Park IP Translations
`
`This is to certify that the attached translation is, to the best
`of my knowledge and belief, a true and accurate translation from
`German into English of German Unexamined Patent Specification
`number DE 198 57 887 A1.
`
`_______________________________________
`Abraham I. Holczer
`Project Manager
`
`Park Case # 41622
`
`NORRED EXHIBIT 2126 - Page 9
`
`15 W. 37th Street 8th Floor (cid:121) New York, N.Y. 10018
`Phone: 212-581-8870 (cid:121) Fax: 212-581-5577