DE 195 46 692 A1
`
`(19) FEDERAL REPUBLIC (12) Unexamined Patent Specification (51) Intl. Cl.6:
`(10) DE 195 46 692 A1
`
` A61 F 2/24
` OF GERMANY
`
`
`
`
`
`
`
`
`
`
` A 61 F 2/06
`
`
`
`
`
`
` A 61 M 29/00
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` A 61 L 27/00
`
`
`
`
`
`
`
` GERMAN
`PATENT OFFICE
`
`
` 195 46 692.6
` (21) Reference number:
`(22) Application date: 14 Dec 1995
` (43) Publication date: 19 Jun 1997
`
`
`
`_____________________________________________________________
`
`(71) Applicant:
`Figulla, Hans-Reiner, Prof., MD, Gottingen,
`Germany (DE) 37085; Ferrari, Markus, MD,
`PhD, Kassel DE 34132
`
`(72) Inventor:
`same as applicant
`
`______________________________________________________________________________________
`
`(54) Self-expanding Heart-Valve Prosthesis for Implantation into the Human Body by Means of
` a Catheter system
`
`(57) It concerns a compressed, self-expanding, heart-valve prosthesis with anchoring supports, which is
` characterized in that it can be introduced, by means of a catheter, into a heart-valve position through a
` femoral artery. After expansion in a beating heart, the prosthesis is independently anchored using
` anchoring barbs, so that replacement of a heart valve can be performed without opening up the thorax.
`
`
`
`
`
`
` The following information was extracted from documents submitted by the applicant
` FEDERAL PRINTING HOUSE Apr 1997 702 025/236
`
` 4/25
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1015 - Page 1
`
`DE 195 46 692 A1
`
`

`

` DE 195 46 692 A1
`
` Description
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
` Prior art to date
`For the replacement of human heart valves, only biological or mechanical valve
`models are available at present, which are surgically sewn tightly through an opening in the
`thorax after removing the diseased heart valve at the heart-valve seat. Thus a heart valve can
`be sewn in, but the patient's circulation must be maintained by a heart-lung machine. Heart
`stoppage is induced, and the heart-valve prosthesis is sewn in while the heart is stopped. The
`drawback to such a procedure is obvious: it involves very serious surgical intervention with
`corresponding risks for the patient and a long post-operative treatment phase. The operation is
`consequently restricted to younger patients and patients who are as healthy as possible. Very
`old patients and patients with severe cardiac insufficiency can no longer be considered for this
`operation.
`Because the heart can be very easily reached here from the outside through the large
`blood vessels without the thorax having to be opened, it is natural to develop a foldable heart
`valve that is self-anchored after expansion and which replaces the diseased heart valve without
`having to open up the thorax.
`
` Presentation of the invention
`
`The invention proposed in the patent claim is based on the problem of fastening a
`foldable, self-expanding, anchoring device so that a more secure fit is ensured after expansion.
`This problem will be solved by means of the features listed in the patent claim.
`To anchor a biological prosthesis, for example, a glutaraldehyde-fixed, swine-heart
`valve or an artificial heart valve made of polyurethane, a 6-10–cm, self-expanding, steel stent
`(vessel support) consisting of 2-3 segments of 5 cm each, is used. This stent has small barbs
`on the outside. A glutaraldehyde-fixed, swine-heart valve is sewn into the area of the side
`facing the heart (Fig. 1). The 6-10–cm long stent is bent into a curve of 5-30 degrees
`(depending on the patient), in order to accomplish a push forward through the curve of the
`aorta. After its expansion, the stent has a diameter of 30-50 mm (depending on the anatomical
`circumstances of the patient) (Fig. 2). The stent / heart-valve system is folded by a funnel and
`is guided in a 24 French (8-mm inside lumen) catheter by means of a flexible guide wire (Fig.
`3). This catheter is brought forward in the ascending aorta through a puncture in the patient's
`femoral artery. Gaps in the area of the stent which mark the coronary ostia are indicated by
`means of X-ray markers. The system is lined up in the ascending aorta, whereby the internal
`X-ray markers that mark the coronary ostia in the stent have to match X-ray markers on the
`catheter. Based on alignment of the system, by means of a second catheter lying in the inner
`lumen, the proximal portion of the stent with the heart valve is expelled by pulling the stent
`catheter back. The stent is thereby unfolded and anchored together with the diseased heart
`valve by supporting it on the aorta wall (Fig. 4). The diseased aortal valve is thereby pulled
`out to the side. After the correct fit of the catheter, the distal portion of the stent is also
`expelled and is anchored in the aorta wall, so that a constant, tight fit of the heart-valve stent
`configuration is possible. In aortal-valve stenoses, a valvuloplasty must be performed before
`the implantation.
`Compared with heart valves implantable to date with a catheter, the following
`invention is distinguished in:
`
` 2
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1015 - Page 2
`
`

`

` DE 195 46 692 A1
`
`
`
`
`
`
`
`
`
`
`1. that a self-expanding stent with anchoring barbs is used,
`2. that the system can be reduced in size in the folded state, which makes its
`introduction possible using the femoral arteries.
`3. that a gap exists in the region of the coronary ostia in the anchoring stent, which is
`portrayed by X-ray marking,
`4. that the alignment of the stent for the coronary ostia is facilitated such that the
`coronary gap markings are also introduced at the expulsion of the catheter,
`5. that the implantation of the heart valve in a beating heart can occur because the
`material ejected from the heart chamber is only insignificantly impeded during
`implantation of the system.
`
`Embodiment examples of the invention are represented in Figs. 1-4.
`Fig. 1: the aortal bioprosthesis or artificial aortal valve is sewn into the proximal
`portion of the self-expanding stent,
`Fig. 2: the aortal bioprosthesis or artificial aortal valve in the proximal portion of the
`multi-component, self-expanding stent,
`Fig. 3: the compressed, aortal bioprosthesis or artificial aortal valves with the folded,
`self-expanding stent is in a 6-8–mm thick catheter. The valve is unfolded by pulling the stent
`out and is anchored in the desired position by the barbs.
`Fig. 4: the aortal bioprosthesis or artificial aortal valve with the self-expanding stent is
`pushed out by pulling the catheter back toward the inside of the catheter and is thereby
`unfolded.
`
` Patent claims
`1. A self-expandable heart-valve prosthesis and anchoring supports for the replacement of
`heart valves by introducing it using a heart catheter system without opening up the thorax,
`characterized in
`1. that a anchoring support (stent) is used as an anchoring system for a glutaraldehyde-
`fixed bioprosthesis or polyurethane heart-valve, 6-10 cm long, 20-50 mm in
`diameter, which exhibits barbs 0.5-1 mm long on its outside .
`2. The device according to claim 1, characterized in that gaps are provided in the area of the
`anchoring supports for the coronary-artery ostia, and these are portrayed by X-ray markings.
`3. The device according to claim 1 or 2, characterized in that the heart-prosthesis segment is
`bent 5-30 degrees.
`4. The device according to claim 1, 2, or 3, characterized in that a heart catheter is used into
`which the prosthesis and anchoring segment is introduced, which indicates on the outside, by
`means of X-ray markings, the alignment of the compressed heart-valve prosthesis.
`5. The device according to claim 1 through 4, characterized in that the heart-valve anchoring
`segment consists of 2-3 self-expanding segments.
`6. The device according to claim 1 through 5, characterized in that implantation can occur in a
`beating heart because obstruction of the blood flow during the implantation is only minor.
`
` _______________________
` Herewith 2 pages of drawings
`
`
`5
`
`10
`
`15
`
`20
`
`25
`
`30
`
`35
`
`40
`
`45
`
` 3
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1015 - Page 3
`
`

`

`
`
`
`
`
`
` – P a g e i n t e n t i o n a l l y b l a n k –
`
` 4
`
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1015 - Page 4
`
`

`

`
`
`DRAWINGS PAGE 1
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Number: DE 195 46 692 A1
` Intl. Cl.6:
` A61 F 2/24
` Publication date: 19 June 1997
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` 5
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1015 - Page 5
`
`

`

`
`
`DRAWINGS PAGE 2
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
`
` Number: DE 195 46 692 A1
` Intl. Cl.6:
` A61 F 2/24
` Publication date: 19 June 1997
`
`Conductivity in 1000 S/cm
`
`
`
` Enthalpy of evaporation in kJ/cm3
`
`
`
` 6
`
`Medtronic, Medtronic Vascular,
`and Medtronic CoreValve
`Exhibit 1015 - Page 6
`
`

`

`July 30, 2013
`
`
`Certification
`
`
`
`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 195 46 692 A1.
`
`
`
`Park IP Translations
`
`
`_______________________________________
`
`Abraham I. Holczer
`
`Project Manager
`
`
`
`
`
`
`
`
`
`
`
`
`
`Park Case # 41622
`
`15 W. 37th Street 8th Floor (cid:121) New York, N.Y. 10018
`Medtronic, Medtronic Vascular,
`Phone: 212-581-8870 (cid:121) Fax: 212-581-5577
`and Medtronic CoreValve
`Exhibit 1015 - Page 7
`
`