Device for fastening and anchoring cardiac valve prostheses Patent Grant Figulla , et al. September 9, 2 [Damm; Christoph]

Device for fastening and anchoring cardiac valve prostheses

Figulla , et al. September 9, 2

Patent Grant RE45130

U.S. patent number RE45,130 [Application Number 12/213,991] was granted by the patent office on 2014-09-09 for device for fastening and anchoring cardiac valve prostheses. This patent grant is currently assigned to JenaValve Technology GmbH. The grantee listed for this patent is Christoph Damm, Markus Ferrari, Hans-Reiner Figulla, Thomas Peschel, Carsten Weber. Invention is credited to Christoph Damm, Markus Ferrari, Hans-Reiner Figulla, Thomas Peschel, Carsten Weber.

United States Patent	RE45,130
Figulla , et al.	September 9, 2014

Device for fastening and anchoring cardiac valve prostheses

Abstract

This invention relates to a device for fastening and anchoring heart valve prostheses which is essentially formed of wire-shaped interconnected elements. The aim of the invention is to be able to be implant, in a minimally invasive manner, a device of this type via the aorta by compressing the device to make it smaller, and by extending the same at the site of implantation, whereby ensuring a secure retention and a secure sealing with regard to the aorta wall. To this end, the invention provides that for fastening and supporting a cardiac valve prosthesis, three identical pairs of arched elements are interconnected, with a configuration that is offset by 120.degree., by means of solid body articulations. These solid body articulations carry out the function of pivot bearings.

Inventors:

Figulla; Hans-Reiner (Jena, DE), Ferrari; Markus (Jena, DE), Weber; Carsten (Jena, DE), Peschel; Thomas (Jena, DE), Damm; Christoph (Jena, DE)

Applicant:

Name	City	State	Country	Type
Figulla; Hans-Reiner Ferrari; Markus Weber; Carsten Peschel; Thomas Damm; Christoph	Jena Jena Jena Jena Jena	N/A N/A N/A N/A N/A	DE DE DE DE DE

Assignee:

JenaValve Technology GmbH (Munich, DE)

Family ID:

7633175

Appl. No.:

12/213,991

Filed:

June 26, 2008

PCT Filed:

February 28, 2001

PCT No.:

PCT/DE01/00837

371(c)(1),(2),(4) Date:

November 25, 2002

PCT Pub. No.:

WO01/62189

PCT Pub. Date:

August 30, 2001

Related U.S. Patent Documents


	Application Number	Filing Date	Patent Number	Issue Date
Reissue of:	10204990	Feb 28, 2001	7198646	Apr 3, 2007

Foreign Application Priority Data


Feb 28, 2000 [DE]			100 10 074

Current U.S. Class:	623/1.15; 623/2.18; 623/900; 623/1.26
Current CPC Class:	A61F 2/2418 (20130101); Y10S 623/90 (20130101); A61F 2230/0054 (20130101)
Current International Class:	A61F 2/24 (20060101); A61F 2/06 (20130101)
Field of Search:	;623/2.11-2.19,1.24,1.26,900,1.15

References Cited [Referenced By]

U.S. Patent Documents


3755823	September 1973	Hancock
4106129	August 1978	Carpentier et al.
RE30912	April 1982	Hancock
4922905	May 1990	Strecker
4994077	February 1991	Dobben
5002566	March 1991	Carpentier et al.
5061277	October 1991	Carpentier et al.
5094661	March 1992	Levy et al.
5104407	April 1992	Lam et al.
5163953	November 1992	Vince
5197979	March 1993	Quintero et al.
5234456	August 1993	Silvestrini
5279612	January 1994	Eberhardt
5332402	July 1994	Teitelbaum
5336258	August 1994	Quintero et al.
5342348	August 1994	Kaplan
5352240	October 1994	Ross
5368608	November 1994	Levy et al.
5397351	March 1995	Pavcnik et al.
5411552	May 1995	Andersen et al.
5456713	October 1995	Chuter
5476508	December 1995	Amstrup
5509930	April 1996	Love
5549666	August 1996	Hata et al.
5595571	January 1997	Jaffe et al.
5613982	March 1997	Goldstein
5632778	May 1997	Goldstein
5674298	October 1997	Levy et al.
5679112	October 1997	Levy et al.
5683451	November 1997	Lenker et al.
5697972	December 1997	Kim et al.
5713953	February 1998	Vallana et al.
5746775	May 1998	Levy et al.
5755777	May 1998	Chuter
5824041	October 1998	Lenker et al.
5824080	October 1998	Lamuraglia
5840081	November 1998	Andersen et al.
5841382	November 1998	Walden et al.
5843181	December 1998	Jaffe et al.
5853419	December 1998	Imran
5855601	January 1999	Bessler et al.
5876434	March 1999	Flomenblit et al.
5880242	March 1999	Hu et al.
5899936	May 1999	Goldstein
5928281	July 1999	Huynh et al.
5935163	August 1999	Gabbay
5104407	September 1999	Lam et al.
5964798	October 1999	Imran
6001126	December 1999	Nguyen-Thien-Nhon
5061277	February 2000	Carpentier et al.
6077297	June 2000	Robinson et al.
6093530	July 2000	McIlroy et al.
6102944	August 2000	Huynh et al.
6117169	September 2000	Moe
6126685	October 2000	Lenker et al.
6146417	November 2000	Ischinger
6168614	January 2001	Andersen et al.
6177514	January 2001	Pathak et al.
6183481	February 2001	Lee et al.
6190405	February 2001	Culombo et al.
6200336	March 2001	Pavcnik et al.
6214055	April 2001	Simionescu et al.
6231602	May 2001	Carpentier et al.
6245102	June 2001	Jayaraman
6254564	July 2001	Wilk et al.
6254636	July 2001	Peredo
6283995	September 2001	Moe et al.
6287338	September 2001	Sarnowski et al.
6338740	January 2002	Carpentier
6342070	January 2002	Nguyen-Thien-Nhon
6344044	February 2002	Fulkerson et al.
6350278	February 2002	Lenker et al.
6379740	April 2002	Rinaldi et al.
6391538	May 2002	Vyavahare et al.
6425916	July 2002	Garrison et al.
6454799	September 2002	Schreck
6471723	October 2002	Ashworth et al.
6478819	November 2002	Moe
6508833	January 2003	Pavcnik et al.
6509145	January 2003	Torrianni
6521179	February 2003	Girardot et al.
6540782	April 2003	Snyders
6558417	May 2003	Peredo
6558418	May 2003	Carpentier et al.
6572642	June 2003	Rinaldi et al.
6582462	June 2003	Andersen et al.
6585766	July 2003	Huynh et al.
6613086	September 2003	Moe et al.
6626939	September 2003	Burnside et al.
6682559	January 2004	Myers et al.
6730118	May 2004	Spenser et al.
6736845	May 2004	Marquez et al.
6743252	June 2004	Bates et al.
6767362	July 2004	Schreck
6773455	August 2004	Allen et al.
6790230	September 2004	Beyersdorf et al.
6808529	October 2004	Fulkerson
6821211	November 2004	Otten et al.
6821297	November 2004	Snyders
6824970	November 2004	Vyavahare et al.
6830584	December 2004	Seguin
6861211	March 2005	Levy et al.
6872226	March 2005	Cali et al.
6881199	April 2005	Wilk et al.
6893460	May 2005	Spenser et al.
6908481	June 2005	Cribier
6911043	June 2005	Myers et al.
6945997	September 2005	Huynh et al.
6974474	December 2005	Pavcnik et al.
7014655	March 2006	Barbarash et al.
7018406	March 2006	Seguin et al.
7037333	May 2006	Myers et al.
7050276	May 2006	Nishiyama
7078163	July 2006	Torrianni
7081132	July 2006	Cook et al.
7137184	November 2006	Schreck et al.
7141064	November 2006	Scott et al.
7163556	January 2007	Xie et al.
7189259	March 2007	Simionescu et al.
7198646	April 2007	Figulla et al.
7201772	April 2007	Schwammenthal et al.
7238200	July 2007	Lee et al.
7252682	August 2007	Seguin
7267686	September 2007	DiMatteo et al.
7318278	January 2008	Zhang et al.
7318998	January 2008	Goldstein et al.
7322932	January 2008	Xie et al.
7329278	February 2008	Seguin et al.
7381218	June 2008	Schreck
7393360	July 2008	Spenser et al.
7399315	July 2008	Iobbi
7452371	November 2008	Pavcnik et al.
7473275	January 2009	Marquez
7704222	April 2010	Wilk et al.
7736327	June 2010	Wilk et al.
2001/0011187	August 2001	Pavcnik et al.
2001/0021872	September 2001	Bailey et al.
2001/0039450	November 2001	Pavcnik et al.
2002/0032481	March 2002	Gabbay
2002/0055775	May 2002	Carpentier et al.
2002/0111668	August 2002	Smith
2002/0123790	September 2002	White et al.
2002/0133226	September 2002	Marquez et al.
2002/0198594	December 2002	Schreck
2003/0027332	February 2003	Lafrance et al.
2003/0036791	February 2003	Philipp et al.
2003/0036795	February 2003	Andersen et al.
2003/0040792	February 2003	Gabbay
2003/0050694	March 2003	Yang et al.
2003/0055495	March 2003	Pease et al.
2003/0065386	April 2003	Weadock
2003/0114913	June 2003	Spenser et al.
2003/0125795	July 2003	Pavcnik et al.
2003/0130726	July 2003	Thorpe et al.
2003/0139796	July 2003	Sequin et al.
2003/0139803	July 2003	Sequin et al.
2003/0149476	August 2003	Damm et al.
2003/0153974	August 2003	Spenser et al.
2003/0195620	October 2003	Huynh et al.
2003/0236570	December 2003	Cook et al.
2004/0006380	January 2004	Buck et al.
2004/0039436	February 2004	Spenser et al.
2004/0049262	March 2004	Obermiller et al.
2004/0073289	April 2004	Hartley et al.
2004/0078950	April 2004	Schreck et al.
2004/0117004	June 2004	Osborne et al.
2004/0117009	June 2004	Cali et al.
2004/0148018	July 2004	Carpentier et al.
2004/0153145	August 2004	Simionescu et al.
2004/0186558	September 2004	Pavcnik et al.
2004/0186563	September 2004	Lobbi
2004/0186565	September 2004	Schreck
2004/0193244	September 2004	Hartley et al.
2004/0210301	October 2004	Obermiller et al.
2004/0210304	October 2004	Seguin et al.
2004/0260389	December 2004	Case et al.
2005/0009000	January 2005	Wilhelm et al.
2005/0033220	February 2005	Wilk et al.
2005/0033398	February 2005	Seguin
2005/0043790	February 2005	Seguin
2005/0049692	March 2005	Numamoto et al.
2005/0075725	April 2005	Rowe
2005/0075776	April 2005	Cho
2005/0096726	May 2005	Sequin et al.
2005/0096736	May 2005	Osse et al.
2005/0098547	May 2005	Cali et al.
2005/0113910	May 2005	Paniagua et al.
2005/0119728	June 2005	Sarac
2005/0119736	June 2005	Zilla et al.
2005/0137687	June 2005	Salahieh et al.
2005/0137688	June 2005	Salahieh et al.
2005/0137690	June 2005	Salahieh et al.
2005/0137697	June 2005	Salahieh et al.
2005/0137698	June 2005	Salahieh et al.
2005/0137702	June 2005	Haug et al.
2005/0143804	June 2005	Haverkost
2005/0143807	June 2005	Pavcnik et al.
2005/0149166	July 2005	Schaeffer et al.
2005/0150775	July 2005	Zhang et al.
2005/0171597	August 2005	Boatman et al.
2005/0171598	August 2005	Schaeffer
2005/0192665	September 2005	Spenser et al.
2005/0197695	September 2005	Stacchino et al.
2005/0222668	October 2005	Schaeffer et al.
2005/0234546	October 2005	Nugent et al.
2005/0267560	December 2005	Bates
2006/0009842	January 2006	Huynh et al.
2006/0025857	February 2006	Bergheim et al.
2006/0047343	March 2006	Oviatt et al.
2006/0058864	March 2006	Schaeffer et al.
2006/0074484	April 2006	Huber
2006/0111770	May 2006	Pavcnik et al.
2006/0142846	June 2006	Pavcnik et al.
2006/0149360	July 2006	Schwammenthal et al.
2006/0167543	July 2006	Bailey et al.
2006/0193885	August 2006	Neethling et al.
2006/0210597	September 2006	Hiles
2006/0229718	October 2006	Marquez
2006/0229719	October 2006	Marquez et al.
2006/0246584	November 2006	Covelli
2006/0259134	November 2006	Schwammenthal et al.
2006/0259136	November 2006	Nguyen et al.
2006/0265056	November 2006	Nguyen et al.
2006/0287717	December 2006	Rowe et al.
2006/0287719	December 2006	Rowe et al.
2006/0290027	December 2006	O'Connor et al.
2006/0293745	December 2006	Carpentier et al.
2007/0005129	January 2007	Damm et al.
2007/0005131	January 2007	Taylor
2007/0005132	January 2007	Simionescu et al.
2007/0020248	January 2007	Everaerts et al.
2007/0021826	January 2007	Case et al.
2007/0027535	February 2007	Purdy, Jr. et al.
2007/0038291	February 2007	Case et al.
2007/0038295	February 2007	Case et al.
2007/0043435	February 2007	Seguin et al.
2007/0050014	March 2007	Johnson
2007/0088431	April 2007	Bourang et al.
2007/0093887	April 2007	Case et al.
2007/0100435	May 2007	Case et al.
2007/0100440	May 2007	Figulla et al.
2007/0112422	May 2007	Dehdashtian
2007/0123700	May 2007	Ueda et al.
2007/0123979	May 2007	Perier et al.
2007/0142906	June 2007	Figulla et al.
2007/0162103	July 2007	Case et al.
2007/0173932	July 2007	Cali et al.
2007/0179592	August 2007	Schaeffer
2007/0185565	August 2007	Schwammenthal et al.
2007/0203576	August 2007	Lee et al.
2007/0213813	September 2007	Von Segesser et al.
2007/0239271	October 2007	Nguyen
2007/0244551	October 2007	Stobie
2007/0260327	November 2007	Case et al.
2007/0288087	December 2007	Fearnot et al.
2008/0004688	January 2008	Spenser et al.
2008/0021546	January 2008	Patz et al.
2008/0033534	February 2008	Cook et al.
2008/0065011	March 2008	Marchand et al.
2008/0071361	March 2008	Tuval et al.
2008/0071362	March 2008	Tuval et al.
2008/0071363	March 2008	Tuval et al.
2008/0071366	March 2008	Tuval et al.
2008/0071368	March 2008	Tuval et al.
2008/0071369	March 2008	Tuval et al.
2008/0077236	March 2008	Letac et al.
2008/0086205	April 2008	Gordy et al.
2008/0097586	April 2008	Pavcnik et al.
2008/0102439	May 2008	Tian et al.
2008/0133003	June 2008	Seguin et al.
2008/0140189	June 2008	Nguyen et al.
2008/0154355	June 2008	Benichou et al.
2008/0200977	August 2008	Paul et al.
2008/0215143	September 2008	Seguin
2008/0262602	October 2008	Wilk et al.
2008/0269878	October 2008	Iobbi
2008/0275549	November 2008	Rowe

Foreign Patent Documents


19546692	Jun 1997	DE
19633901	Feb 1998	DE
20003874	Jun 2000	DE
19857887	Jul 2000	DE
10010073	Sep 2001	DE
10010074	Oct 2001	DE
101 21 210	Nov 2002	DE
19546692	Nov 2002	DE
10010074	Apr 2005	DE
19857887	May 2005	DE
10010073	Dec 2005	DE
0084395	Jul 1983	EP
0458877	Aug 1990	EP
0402036	Dec 1990	EP
0402176	Dec 1990	EP
0458877	Apr 1991	EP
0515324	Nov 1992	EP
0547135	Jun 1993	EP
0871414	Sep 1995	EP
0 592 410	Oct 1995	EP
0756498	Oct 1995	EP
0 592 410	Nov 1995	EP
0786970	May 1996	EP
0729364	Sep 1996	EP
0756498	May 1997	EP
0778775	Jun 1997	EP
0786970	Aug 1997	EP
0888142	Sep 1997	EP
0971649	Oct 1998	EP
0928615	Jul 1999	EP
1051204	Jul 1999	EP
1089676	Dec 1999	EP
0986348	Mar 2000	EP
1117446	Apr 2000	EP
1 164 976	Aug 2000	EP
1158937	Sep 2000	EP
1 251 805	Oct 2000	EP
1041942	Oct 2000	EP
1041943	Oct 2000	EP
1171061	Oct 2000	EP
1206179	Feb 2001	EP
1 233 731	May 2001	EP
1117446	Jul 2001	EP
1 255 510	Aug 2001	EP
1259193	Sep 2001	EP
1 233 731	May 2002	EP
1 330 213	May 2002	EP
1206179	May 2002	EP
1347785	Aug 2002	EP
1235537	Sep 2002	EP
1248655	Oct 2002	EP
1251804	Oct 2002	EP
1257305	Nov 2002	EP
0 971 649	Dec 2002	EP
1395208	Dec 2002	EP
1 401 359	Jan 2003	EP
1406561	Jan 2003	EP
1281357	Feb 2003	EP
1408882	Feb 2003	EP
1 435 878	Apr 2003	EP
1 435 879	Apr 2003	EP
1 441 672	Jun 2003	EP
1 017 868	Sep 2003	EP
1354569	Oct 2003	EP
1494616	Oct 2003	EP
1 519 697	Jan 2004	EP
1 539 047	Apr 2004	EP
1551274	Apr 2004	EP
1 560 542	May 2004	EP
1414295	May 2004	EP
1 603 493	Sep 2004	EP
1452153	Sep 2004	EP
0987998	Oct 2004	EP
1 087 727	Nov 2004	EP
1499366	Jan 2005	EP
1 663 070	Mar 2005	EP
1 253 875	Apr 2005	EP
1 667 614	Apr 2005	EP
1 251 803	Jun 2005	EP
1 702 247	Jul 2005	EP
1734902	Aug 2005	EP
1835948	Jun 2006	EP
1863545	Sep 2006	EP
1893132	Nov 2006	EP
1901681	Dec 2006	EP
1 255 510	Mar 2007	EP
1835948	Sep 2007	EP
1112042	Nov 2007	EP
1878407	Jan 2008	EP
1886649	Feb 2008	EP
1 900 343	Mar 2008	EP
1259195	Oct 2008	EP
1994913	Nov 2008	EP
2 000 115	Dec 2008	EP
2440809	Feb 2008	GB
52-086296	Jul 1977	JP
62-227352	Oct 1987	JP
2002-525169	Aug 2002	JP
2002-536115	Oct 2002	JP
2003-523262	Aug 2003	JP
2003-524504	Aug 2003	JP
2005-118585	May 2005	JP
2007-296375	Nov 2007	JP
WO-90/09102	Aug 1990	WO
WO 91/17720	Nov 1991	WO
WO-95/24873	Sep 1995	WO
WO-95/28183	Oct 1995	WO
WO-96/13227	May 1996	WO
WO-97/32615	Sep 1997	WO
WO-98/43556	Oct 1998	WO
WO-98/46165	Oct 1998	WO
WO-99/37337	Jul 1999	WO
WO-99/66863	Dec 1999	WO
WO 00/15148	Mar 2000	WO
WO 00/18333	Apr 2000	WO
WO-00/18445	Apr 2000	WO
WO 00/25702	May 2000	WO
WO 00/047139	Aug 2000	WO
WO 00/47139	Aug 2000	WO
WO-00/53125	Sep 2000	WO
WO-00/62714	Oct 2000	WO
WO-01/10209	Feb 2001	WO
WO 01/35870	May 2001	WO
WO-01/41679	Jun 2001	WO
WO-01/51104	Jul 2001	WO
WO 01/54625	Aug 2001	WO
WO-01/58503	Aug 2001	WO
WO 01/62189	Aug 2001	WO
WO 01/64137	Sep 2001	WO
WO 02/36048	May 2002	WO
WO-02/058745	Aug 2002	WO
WO-02/100301	Dec 2002	WO
WO-02/102286	Dec 2002	WO
WO 03/003949	Jan 2003	WO
WO-03/007795	Jan 2003	WO
WO-03/009785	Feb 2003	WO
WO 03/011195	Feb 2003	WO
WO 03/013239	Feb 2003	WO
WO 03/028592	Apr 2003	WO
WO 03/047468	Jun 2003	WO
WO 00/047139	Aug 2003	WO
WO-03/079928	Oct 2003	WO
WO 03/096935	Nov 2003	WO
WO 2004/004597	Jan 2004	WO
WO 2004/016200	Feb 2004	WO
WO 2004/016201	Feb 2004	WO
WO 2004/019825	Mar 2004	WO
WO-2004/026117	Apr 2004	WO
WO 2004/026173	Apr 2004	WO
WO 2004/043301	May 2004	WO
WO 2004/082527	Sep 2004	WO
WO 2004/096100	Nov 2004	WO
WO 2005/021063	Mar 2005	WO
WO 2005/034812	Apr 2005	WO
WO 2005/062980	Jul 2005	WO
WO 2005/063980	Jul 2005	WO
WO-2005/072654	Aug 2005	WO
WO 2006/066327	Jun 2006	WO
WO-2006/066327	Jun 2006	WO
WO 2006/076890	Jul 2006	WO
WO-2006/102063	Sep 2006	WO
WO 2006/108090	Oct 2006	WO
WO 2006/124649	Nov 2006	WO
WO-2006/124649	Nov 2006	WO
WO 2006/127756	Nov 2006	WO
WO 2006/127765	Nov 2006	WO
WO-2006/132948	Dec 2006	WO
WO 2007/047488	Apr 2007	WO
WO 2007/047945	Apr 2007	WO
WO 2007/059252	May 2007	WO
WO-2007/071436	Jun 2007	WO
WO 2007/120543	Oct 2007	WO
WO-2008/028569	Mar 2008	WO
WO 2008/045949	Apr 2008	WO
WO 2008/070797	Jun 2008	WO
WO 2008/079962	Jul 2008	WO
WO 2008/101083	Aug 2008	WO

Other References

Aortenklappenbioprothese erfolgreich in der Entwicklung, (1 page) May 16, 2003. cited by applicant .
Translation of Aortenklappenbioprothese erfolgreich in der Entwicklung (2 pages). cited by applicant .
Screen shots from http://www.fraunhofer.de/presse/filme/2006/index.jsp (2 pages), 2006. cited by applicant .
Liang, Ma, et al., "Double-crowned valved stents for off-pump mitrel valve replacement," European Journal of Cardio-Thoracic Surgery, 194-198 (5 pages), Jun. 13, 2005. cited by applicant .
Huber, Christoph, et al. "Direct Access Valve Replacement (DAVR)--are we entering a new era in cardiac surgery?" European Journal of Cardio-Thoracic Surgery, 380-385, (6 pages), Jan. 19, 2006. cited by applicant .
Translation of DE 19546692 A1 (4 pages). cited by applicant .
File history for German Patent DE 195 46 692 filed Dec. 14, 1995 and patented Jul. 11, 2002. cited by applicant.

Primary Examiner: Sweet; Thomas J
Assistant Examiner: Miller; Cheryl
Attorney, Agent or Firm: Bookoff McAndrews, PLLC

Claims

The invention claimed is:

1. A device for fastening and anchoring a heart valve prosthesis, the device consisting of three identical sections, each section being coupled to adjacent sections on each side of said section by an elongated supporting ridge extending in a direction generally parallel to a longitudinal axis of the device, each section having a first arched element arched in a first direction, a second arched element arched in the first direction, and a third arched element arched in a second direction opposite from the first direction, the second and third arched elements being coupled to the first arched element at first points to define between the first and second arched elements a first space, each section further comprising a fourth arched element arched in the second direction and having ends coupled to the first arched element of said section and .[.a.]. .Iadd.the .Iaddend.first arched element of an adjacent section at second points distinct from the first points to define between the fourth arched element and the adjacent first arched elements a second space.

2. A device for supporting a heart valve prosthesis, the device consisting essentially of three substantially identical elements, each element being coupled to adjacent elements on each side of said element by an elongated supporting member extending in a direction generally parallel to a longitudinal axis of the device, each element including a first arched member coupled to, and extending in a first direction generally away from said first arched member's respective supporting members, and a second arched member coupled to the first arched member at points different from the first arched member's coupling to its respective supporting members, the second arched member extending generally in a second direction opposite from the first direction, wherein each element further includes a third arched member coupled to the first arched member at substantially the same points as the second arched member is coupled to the first arched member, the third arched member extending generally in the first direction, each element further including a pair of fourth arched members, each of said fourth arched members extending alongside, and conforming generally to, the curvature of a portion of the first arched member, each of the fourth arched members being coupled to a first arched member intermediate opposite ends of said first arched member and extending from said coupling to said first arched member generally in said second direction toward a respective supporting member.

3. The device of claim 2 wherein each fourth arched member extends to a point adjacent a respective supporting member, turns, and extends generally in the first direction, conforming generally to the curvature of a portion of a first arched member of an adjacent element on one side of said element.

4. The device of claim 3 wherein each element further includes transversal members extending between its respective supporting members.

5. The device of claim 4 wherein at least some of said transversal members include tips to facilitate anchoring of said device into tissue of a vessel or the heart of a wearer of the device.

6. The device of claim 4 constructed from memory metal.

7. The device of claim 3 constructed from memory metal.

8. The device of claim 2 wherein each element further includes transversal members extending between its respective supporting members.

9. The device of claim 8 wherein at least some of said transversal members include tips to facilitate anchoring of said device into tissue of a vessel or the heart of a wearer of the device.

10. The device of claim 8 constructed from memory metal.

11. The device of claim 2 constructed from memory metal.

.Iadd.12. A medical device, in combination with a heart valve prosthesis, the medical device consisting of three substantially identical sections, each section being coupled to adjacent sections on each side of the section, the medical device being implantable in a body via a catheter and including a collapsed mode and an expanded mode, each section including: a first arched element arched in a first direction, the first arched element disposed at a distal end of the device; a second arched element arched in the first direction, the second arched element disposed at the distal end of the device and connected to the first arched element at first points; and a fourth arched element arched in a second direction opposite from the first direction and having ends coupled to the first arched element of said section and the first arched element of an adjacent section at second points distinct from the first points to define between the fourth arched element and the adjacent first arched elements a space; wherein the heart valve prosthesis is fixedly attached to the first, second, and fourth arched elements of each of the three sections and remains fixedly attached to function as a heart valve after removal of the catheter from the body, the heart valve prosthesis repeatedly opening and closing to allow and prevent blood flow, respectively, through the medical device..Iaddend.

.Iadd.13. The medical device, in combination with the heart valve prosthesis of claim 12, each section further including: a third arched element arched in the second direction, the third arched element connected to the first and second arched elements at the first points..Iaddend.

.Iadd.14. The medical device, in combination with the heart valve prosthesis of claim 13, wherein each section further includes an eyelet element disposed at a proximal end of the device opposite the distal end..Iaddend.

.Iadd.15. The medical device, in combination with the heart valve prosthesis of claim 12, wherein each of the three fourth arched elements conforms generally to a curvature of a portion of the first arched element of the first section and the curvature of a portion of the first arched element of the adjacent section..Iaddend.

.Iadd.16. The medical device, in combination with the heart valve prosthesis of claim 12, wherein at least one of the second points pivots when a pressure force is exerted upon one of the first or fourth arched elements..Iaddend.

.Iadd.17. The medical device, in combination with the heart valve prosthesis of claim 12, wherein the device is configured to be implanted within an aorta..Iaddend.

.Iadd.18. The medical device, in combination with the heart valve prosthesis of claim 12, wherein each section is coupled to the adjacent sections by a supporting ridge, each section further including transversal members extending between adjacent elongated supporting ridges..Iaddend.

.Iadd.19. The medical device, in combination with the heart valve prosthesis of claim 18, wherein at least some of said transversal members include tips to facilitate anchoring of said device into tissue of a vessel or a heart of a patient..Iaddend.

.Iadd.20. The medical device, in combination with the heart valve prosthesis of claim 18, wherein the transversal members have a saw-tooth shape..Iaddend.

.Iadd.21. The medical device, in combination with the heart valve prosthesis of claim 18, wherein the transversal members have a rhombic shape..Iaddend.

.Iadd.22. The medical device, in combination with the heart valve prosthesis of claim 12, wherein the heart valve prosthesis is a biological heart valve prosthesis..Iaddend.

.Iadd.23. The medical device, in combination with the heart valve prosthesis of claim 12, wherein the heart valve prosthesis is an artificial heart valve prosthesis..Iaddend.

.Iadd.24. The medical device, in combination with the heart valve prosthesis of claim 12, wherein the three sections are spaced substantially 120 degrees apart..Iaddend.

.Iadd.25. The medical device, in combination with the heart valve prosthesis of claim 12, wherein the device is constructed from memory metal..Iaddend.

.Iadd.26. The medical device, in combination with the heart valve prosthesis of claim 12, wherein the device is balloon expandable..Iaddend.

.Iadd.27. A medical device, in combination with a heart valve prosthesis, the medical device consisting of three substantially identical sections, each section being coupled to adjacent sections on each side of the section, the medical device being implantable in a body via a catheter and having a first, compressed mode and a second, expanded mode, each section including: a first arched element arched in a first direction, the first arched element disposed at a distal end of the device; a third arched element arched in a second direction opposite from the first direction, the first and third arched elements connected to each other at a first point, wherein between an apex of the first arched element and an apex of the third arched element there is a space; and a fourth arched element arched in a direction opposite from the first direction and having a first end coupled to the first arched element of said section at a second point and a second end coupled to the first arched element of an adjacent section at a third point, the second point and the third point being distinct from the first point to define between the fourth arched element and the adjacent first arched elements a space; wherein the heart valve prosthesis is fixedly attached to the first and fourth arched elements of each of the three sections and remains fixedly attached to function as a heart valve after removal of the catheter from the body, the heart valve prosthesis repeatedly opening and closing to allow and prevent blood flow, respectively, through the medical device..Iaddend.

.Iadd.28. The medical device, in combination with the heart valve prosthesis of claim 27, wherein the first point is a pivot point about which the third arched element can move..Iaddend.

.Iadd.29. A medical device, in combination with a heart valve prosthesis fixedly attached to the medical device, the medical device consisting of three substantially identical sections, each section being coupled to adjacent sections on each side of the section, the medical device being implantable in a body via a catheter and having a first, compressed mode and a second, expanded mode, each section including: a first arched element arched in a first direction, the first arched element connected to a supporting ridge and disposed on a first, distal end of the supporting ridge; a third arched element arched in a second direction opposite from the first direction, the first and third arched elements connected to each other at a first point, wherein between an apex of the first arched element and an apex of the third arched element there is a space; and a fourth arched element arched in a direction opposite from the first direction and having ends coupled to the first arched element of said section and the first arched element of an adjacent section, wherein a curvature of the fourth arched element is different from a curvature of the third arched element; and a plurality of undulating transverse ridges connected to the supporting ridge and disposed on a second, proximal end of the supporting ridge opposite the first, distal end, such that the supporting ridge is disposed proximal to the first arched element and distal to the plurality of undulating transverse ridges, the plurality of undulating transverse ridges including at least two sets of undulating transverse ridges, each set of undulating transverse ridges extending around a circumference of the medical device; wherein the heart valve prosthesis remains fixedly attached to the medical device to function as a heart valve after removal of the catheter from the body, the heart valve prosthesis repeatedly opening and closing to allow and prevent blood flow, respectively, through the medical device..Iaddend.

.Iadd.30. The medical device, in combination with a heart valve prosthesis of claim 29, further including an eyelet element connected to at least one of the plurality of undulating transverse ridges..Iaddend.

.Iadd.31. The medical device, in combination with a heart valve prosthesis of claim 29, wherein the plurality of undulating transverse ridges form a supporting body configured to engage a portion of a vessel wall when the medical device is in the expanded mode at a deployed state..Iaddend.

.Iadd.32. The medical device, in combination with a heart valve prosthesis of claim 29, wherein the device is configured to be implanted within an aorta..Iaddend.

.Iadd.33. The medical device, in combination with a heart valve prosthesis of claim 29, wherein at least one of the plurality of undulating transverse ridges includes tips to facilitate anchoring of the device into tissue of a vessel or a heart of a patient..Iaddend.

.Iadd.34. The medical device, in combination with a heart valve prosthesis of claim 29, wherein the plurality of undulating transverse ridges have a saw-tooth shape..Iaddend.

.Iadd.35. The medical device, in combination with a heart valve prosthesis of claim 29, wherein the plurality of undulating transverse ridges have a rhombic shape..Iaddend.

.Iadd.36. The medical device, in combination with a heart valve prosthesis of claim 29, wherein the heart valve prosthesis is a biological heart valve prosthesis..Iaddend.

.Iadd.37. The medical device, in combination with a heart valve prosthesis of claim 29, wherein the heart valve prosthesis is an artificial heart valve prosthesis..Iaddend.

.Iadd.38. The medical device, in combination with a heart valve prosthesis of claim 29, wherein the three sections are spaced substantially 120 degrees apart..Iaddend.

.Iadd.39. The medical device, in combination with a heart valve prosthesis of claim 29, wherein the device is constructed from memory metal..Iaddend.

.Iadd.40. The medical device, in combination with a heart valve prosthesis of claim 29, wherein the device is balloon expandable..Iaddend.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS

This application is a U.S. national counterpart application of international application serial no. PCT/DE01/00837 filed Feb. 28, 2001, which claims priority to German application serial No. 100 10 074.0 filed Feb. 28, 2000.

BACKGROUND AND SUMMARY OF THE INVENTION

The invention relates to a device for fastening and anchoring cardiac valve prostheses which is essentially formed of wire-shaped interconnected elements. In the folded up state it is allowed to be introduced through the aorta in a minimally invasive manner, and be anchored in the aorta wall after being deployed such that the implanted and secured heart valve prosthesis is allowed to adopt the function of the endogenous heart valve.

Heretofore, it did not succeed in a satisfactory extent to suggest a solution wherein both a secure sealing against the aorta wall and a secure retention can be ensured. On that occasion, such a device or such an anchoring support (stent) must be able to be folded up small enough in order to be stretched then at the site of implantation. With the known solutions a satisfactory enlargement will not be achieved with the appropriate tension force which is allowed to ensure such a retention. Proposals in which a form storage metal (memory metal) is to be used as well do not meet the requirements although an expansion takes place with these materials when a transition temperature has been reached and exceeded, respectively.

The solution as described in U.S. Pat. No. 5,411,552 cannot meet the requirements as well since a relatively instable object is to be used.

Another problem which is solved in an unsatisfactory manner so far is the secure attachment of an artificial or biological heart valve prosthesis. As a rule, the prostheses are lavishly sewn on to a stent. This is time-consuming and has to be carried out with great care in order to avoid damages.

Since the implanted heart valve prostheses have to be able to function over long periods the constructional design plays an essential role as well since damages and leakages can occur after the implantation otherwise which can result in life threatening states of the patient.

Hence, it is an object of the invention to suggest a device for fastening and anchoring heart valve prostheses which can be folded up small enough, and deployed at the site of implantation for a minimally invasive implantation through the aorta wherein a secure retention and a secure sealing with respect to the aorta wall are ensured.

According to the invention this object is solved with a device according to claim 1.

Advantageous embodiments and improvements of the invention can be achieved with the features mentioned in the subclaims.

Three identical pairs of arched elements each are substantial elements of the solution according to the invention which are interconnected in a configuration that is offset by 120.degree.. The two arched elements of one pair are bent opposite to each other in a curved manner and connected by means of solid articulations. The solid articulations simultaneously meet the function of pivot bearings about which the arched elements of one pair can be swivelled similarly as with a seesaw. If a pressure force is exerted upon one of the arched elements, e.g. through the peristaltic action of the aorta, this arched element will be swivelled according to the same direction about the axis of rotation on the solid articulation. Simultaneously, the respective other arched element of the pair will be swivelled opposite thereto. Therefore, one of the two arched elements of the pair is then already pressed against the aorta wall increasing the sealing and the retention.

It is favourable to dimension the arched elements of a pair such that as far as possible the same lever relations are met with respect to the solid articulations forming the pivot bearings, thus rocker arms with an identical length or at least with approximately the same length will be formed.

The relative great distances of the solid articulations predetermined by the configuration of 120.degree. of the pairs of arched elements, and the large surface areas covered by the arched elements as well are also advantageous wherein the distal arched elements do not only serve for fastening the heart valve prosthesis but also adopt a supporting function.

The mentioned advantages can still be improved by means of another curved arched element which is arranged in the distal direction.

On that occasion, the second distal arched element in its distal area is designed in a curved manner approximately like the first distal arched element. Partly, these two arched elements are designed and shaped such that they pass adjacent to each other, and gaps are formed between them. They are allowed to be interconnected at the same place at which the solid articulations are also arranged as a connection toward the arched element curved in the proximal direction. Hence, the formed gaps are open in the distal direction, and portions of the heart valve prosthesis are allowed to be introduced into the gaps and be supported.

At least one portion of a distal arched element is proximally retracted and guided up to a turning point in which adjacent arched elements are collected. With two distally arranged arched elements this applies to the respective distally outer arched element.

For stiffening and as a further possibility of fastening the heart valve prosthesis it is allowed to use an angular curved arched element being proximally retracted as well, the curved portions of which are located between the respective adjacent arched elements and are formed partly following the respective curvature. These arched elements with the distal ends thereof are secured to the one distally outer arched element or the respective distally outer arched element. Herein, the attachment also forms a respective solid articulation. These should still be located in a distance to the other solid articulations connecting one pair.

With a device being implanted and stretched over the pockets of a heart valve prosthesis then can be pushed in, held and supported there.

The construction of the arched element of the device according to the invention supports a heart valve prosthesis in a large-surface manner, and therefore with care. Additionally, it is allowed to be fastened with a substantially lower amount, for example by sewing.

The constructional solution enables a secure retention and the required sealing on the aorta wall, and with respect thereto, respectively. Pressing against the heart valve prosthesis from the inside by means of the arched element is advantageous for the sealing and for a reduced load of the heart valve prosthesis.

The device according to the invention can be implanted by means of a balloon catheter and can be deployed at the site of implatation. Advantageously, for the device is used a form storage metal as well having a suitable transition temperature by means of which an extension can be additionally achieved. For this, an alloy containing nickel and titanium can be employed which is available under the designation of Nitinol.

Moreover, the portion of the device supporting and holding the heart valve prosthesis can be implanted separately to a supporting body which is still referred to hereinafter with the description of an embodiment without reducing the advantageous properties. The implantation of this portion substantially consisting of the three segments having the heart valve prosthesis attached thereto then can operatively take place in a conventional form.

In the text that follows, the invention will be explained in more detail according to an embodiment in which

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1 shows a developed view of an embodiment of a device according to the invention.

DETAILED DESCRIPTION OF THE DRAWINGS

In FIG. 1 is shown a developed view of an embodiment of a device according to the invention. The device is radially symmetrically designed wherein three identical portions are used in a configuration of 120.degree..

Each portion uses an arched element construction as a carrier and for fastening an artificial or biological heart valve prosthesis.

With this embodiment two arched elements 4 and 5 are used which are distally arranged outside wherein the outer arched element 5 could be abandoned as the case may be.

The arched element 4 bent into a curved manner is connected to an arched element 3 which is bent in the opposite direction. The two sided connections represent solid articulations 7 which simultaneously adopt pivot functions for the two arched elements 3 and 4 representing levers as it is already described in the general part of the description.

The second arched element 3 which is outwardly bent and distally arranged increases the stability and offers an additional supporting and fastening possibility for the heart valve prosthesis. On that occasion, the two distally outer arched elements 4 and 5 are interconnected as well, wherein this connection is allowed to occur at the same place at which the solid articulations 7 are also arranged.

There are gaps between the two arched elements 4 and 5 which are open from the distal direction into which the portions of the heart valve prosthesis can be introduced and fixed there.

The arched element 5 being the outer one here is further inwardly pulled in the proximal direction, and is connected with its end to a respective supporting ridge 8. In this embodiment, the supporting ridges 8 are aligned in parallel to the longitudinal axis of the device, and together with saw tooth shaped, rhombic or meander shaped transversal ridges they form a supporting body which in the deployed state closely fits on the aorta wall. For interlocking, additional tips 9 can be present and designed, respectively, on the supporting ridges 8, and/or the transversal ridges which interlock in the aorta wall.

The configuration and length of the supporting ridges 8, and the respective great distance toward the heart valve prosthesis fastened in the area of the arched elements 3, 4 and 5 enable positioning the heart valve prosthesis without locking and covering the coronary vessels, respectively.

With the embodiment as shown herein, additional arched elements 2 being proximally pulled in are present between the individual segments used in a configuration of 120.degree. which are connected to the distally outer arched elements 5. Herein, the connections are solid articulations 6 as well, however, which should be arranged in a distance toward the solid articulations 7 as far as possible. Thus, two levers per segment can be used, and forces twice as large can be realized with such a double-reflected structure in order to fix the device.

In the deployed implanted state the portions of the heart valve prosthesis can be mutually introduced in turn between the portions 1 of the arched elements 5 and the arched elements 2, thus being supported and fixed thereto.

The number of the arched elements used can still be increased, however, to improve the retention and to further decrease the load of the heart valve prosthesis.

* * * * *

References

fraunhofer.de/presse/filme/2006/index.jsp