U.S. patent number RE46,927 [Application Number 14/152,810] was granted by the patent office on 2018-07-03 for heart band with fillable chambers to modify heart valve function.
This patent grant is currently assigned to Mardil, Inc.. The grantee listed for this patent is Mardil, Inc.. Invention is credited to Karl R. Leinsing, Jaishankar Raman.
United States Patent |
RE46,927 |
Leinsing , et al. |
July 3, 2018 |
**Please see images for:
( Certificate of Correction ) ** |
Heart band with fillable chambers to modify heart valve
function
Abstract
The present invention relates to an external heart device,
having a layered band dimensioned to be received around a patient's
heart, which also includes at least one fillable chamber between
the layers in the band that functions to apply localized pressure
to the outside of the heart when filled. More particularly, the
fillable chambers are positioned such that they exert an inward
radial force on a heart valve. Areas between the fillable chambers
may also be sized and positioned to form a bridge of little to no
pressure over the vascular structures of the heart.
Inventors: |
Leinsing; Karl R. (Dover,
NH), Raman; Jaishankar (Chicago, IL) |
Applicant: |
Name |
City |
State |
Country |
Type |
Mardil, Inc. |
Plymouth |
MN |
US |
|
|
Assignee: |
Mardil, Inc. (Plymouth,
MN)
|
Family
ID: |
40408558 |
Appl.
No.: |
14/152,810 |
Filed: |
January 10, 2014 |
Related U.S. Patent Documents
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Application
Number |
Filing Date |
Patent Number |
Issue Date |
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Reissue of: |
11899253 |
Sep 5, 2007 |
8092363 |
Jan 10, 2012 |
|
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Current U.S.
Class: |
1/1 |
Current CPC
Class: |
A61F
2/2481 (20130101); A61F 2/2481 (20130101) |
Current International
Class: |
A61N
1/362 (20060101); A61F 2/24 (20060101) |
Field of
Search: |
;600/16,17
;623/3.16,3.2 |
References Cited
[Referenced By]
U.S. Patent Documents
|
|
|
3587567 |
June 1971 |
Schiff |
3983863 |
October 1976 |
Janke et al. |
4048990 |
September 1977 |
Goetz |
4403604 |
September 1983 |
Wilkinson et al. |
4428375 |
January 1984 |
Ellman |
4536893 |
August 1985 |
Parravicini |
4630597 |
December 1986 |
Kantrowitz et al. |
4690134 |
September 1987 |
Snyders |
4821723 |
April 1989 |
Baker, Jr. et al. |
4878890 |
November 1989 |
Bilweis |
4936857 |
June 1990 |
Kulik |
4957477 |
September 1990 |
Lundback |
4973300 |
November 1990 |
Wright |
4976730 |
December 1990 |
Kwan-Gett |
5057117 |
October 1991 |
Atweh |
5087243 |
February 1992 |
Avitall |
5131905 |
July 1992 |
Grooters |
5150706 |
September 1992 |
Cox et al. |
5186711 |
February 1993 |
Epstein |
5192314 |
March 1993 |
Daskalakis |
5256132 |
October 1993 |
Snyders |
5290217 |
March 1994 |
Campos |
5356432 |
October 1994 |
Rutkow et al. |
5383840 |
January 1995 |
Heilman et al. |
5385156 |
January 1995 |
Oliva |
5429584 |
July 1995 |
Chiu |
5507779 |
April 1996 |
Altman |
5524633 |
June 1996 |
Heaven et al. |
5558617 |
September 1996 |
Heilman et al. |
5603337 |
February 1997 |
Jarvik |
5647380 |
July 1997 |
Campbell et al. |
5702343 |
December 1997 |
Alferness |
5713954 |
February 1998 |
Rosenberg et al. |
5800528 |
September 1998 |
Lederman et al. |
5961440 |
October 1999 |
Schweich, Jr. et al. |
5976551 |
November 1999 |
Mottez et al. |
6045497 |
April 2000 |
Schweich, Jr. et al. |
6050936 |
April 2000 |
Schweich, Jr. et al. |
6059715 |
May 2000 |
Schweich, Jr. et al. |
6076013 |
June 2000 |
Brennan et al. |
6077214 |
June 2000 |
Mortier et al. |
6077218 |
June 2000 |
Alferness |
6085754 |
July 2000 |
Alferness et al. |
6123662 |
September 2000 |
Alferness |
6126590 |
October 2000 |
Alferness |
6155968 |
December 2000 |
Wilk |
6155972 |
December 2000 |
Nauertz et al. |
6162168 |
December 2000 |
Schweich, Jr. et al. |
6165119 |
December 2000 |
Schweich, Jr. et al. |
6165120 |
December 2000 |
Schweich, Jr. et al. |
6165121 |
December 2000 |
Alferness |
6165122 |
December 2000 |
Alferness |
6169922 |
January 2001 |
Alferness et al. |
6174279 |
January 2001 |
Girard |
6179791 |
January 2001 |
Krueger |
6183411 |
February 2001 |
Mortier et al. |
6190408 |
February 2001 |
Melvin |
6193646 |
February 2001 |
Kulisz et al. |
6206820 |
March 2001 |
Kazi |
6221103 |
April 2001 |
Melvin |
6230714 |
May 2001 |
Alferness et al. |
6241654 |
June 2001 |
Alferness |
6260552 |
July 2001 |
Mortier et al. |
6261222 |
July 2001 |
Schweich, Jr. et al. |
6264602 |
July 2001 |
Mortier et al. |
6293906 |
September 2001 |
Vanden Hoek et al. |
6332863 |
December 2001 |
Schweich, Jr. et al. |
6332864 |
December 2001 |
Schweich, Jr. et al. |
6332893 |
December 2001 |
Mortier et al. |
6370429 |
April 2002 |
Alferness et al. |
6375608 |
April 2002 |
Alferness |
6402679 |
June 2002 |
Mortier |
6402680 |
June 2002 |
Mortier |
6406420 |
June 2002 |
McCarthy et al. |
6409760 |
June 2002 |
Melvin |
6416459 |
July 2002 |
Haindl |
6425856 |
July 2002 |
Shapland et al. |
6432039 |
August 2002 |
Wardle |
6482146 |
November 2002 |
Alferness et al. |
6488618 |
December 2002 |
Paolitto et al. |
6494825 |
December 2002 |
Talpade |
6508756 |
January 2003 |
Kung et al. |
6514194 |
February 2003 |
Schweich, Jr. et al. |
6520904 |
February 2003 |
Melvin |
6537198 |
March 2003 |
Vidlund et al. |
6537203 |
March 2003 |
Alferness et al. |
6544168 |
April 2003 |
Alferness |
6547716 |
April 2003 |
Milbocker |
6558319 |
May 2003 |
Aboul-Hosn et al. |
6564094 |
May 2003 |
Alferness et al. |
6567699 |
May 2003 |
Alferness et al. |
6569082 |
May 2003 |
Chin |
6572533 |
June 2003 |
Shapland et al. |
6572534 |
June 2003 |
Milbocker |
6575921 |
June 2003 |
Vanden Hoek et al. |
6579226 |
June 2003 |
Vanden Hoek et al. |
6582355 |
June 2003 |
Alferness et al. |
6587734 |
July 2003 |
Okuzumi et al. |
6589160 |
July 2003 |
Schweich, Jr. et al. |
6592514 |
July 2003 |
Kolata et al. |
6595912 |
July 2003 |
Lau et al. |
6602184 |
August 2003 |
Lau et al. |
6612978 |
September 2003 |
Lau et al. |
6612979 |
September 2003 |
Lau et al. |
6616596 |
September 2003 |
Milbocker |
6616684 |
September 2003 |
Vidlund et al. |
6622730 |
September 2003 |
Ekvall et al. |
6626821 |
September 2003 |
Kung |
6629921 |
October 2003 |
Schweich, Jr. et al. |
6645139 |
November 2003 |
Haindl |
6663558 |
December 2003 |
Lau et al. |
6673009 |
January 2004 |
Vanden Hoek et al. |
6682474 |
January 2004 |
Lau et al. |
6682475 |
January 2004 |
Cox et al. |
6682476 |
January 2004 |
Alferness et al. |
6685627 |
February 2004 |
Jayaraman |
6689048 |
February 2004 |
Vanden Hoek et al. |
6695768 |
February 2004 |
Levine et al. |
6695769 |
February 2004 |
French et al. |
6701929 |
March 2004 |
Hussein |
6702732 |
March 2004 |
Lau et al. |
6709382 |
March 2004 |
Horner |
6716158 |
April 2004 |
Raman et al. |
6723038 |
April 2004 |
Schroeder et al. |
6723041 |
April 2004 |
Lau et al. |
6726696 |
April 2004 |
Houser et al. |
6726920 |
April 2004 |
Theeuwes et al. |
6730016 |
May 2004 |
Cox et al. |
6746471 |
June 2004 |
Mortier et al. |
6755777 |
June 2004 |
Schweich, Jr. et al. |
6755779 |
June 2004 |
Vanden Hoek et al. |
6755861 |
June 2004 |
Nakao |
6764510 |
July 2004 |
Vidlund et al. |
6776754 |
August 2004 |
Wilk |
6793618 |
September 2004 |
Schweich, Jr. et al. |
6808488 |
October 2004 |
Mortier et al. |
6852075 |
February 2005 |
Taylor |
6852076 |
February 2005 |
Nikolic et al. |
6858001 |
February 2005 |
Aboul-Hosn |
6876887 |
April 2005 |
Okuzumi et al. |
6881185 |
April 2005 |
Vanden Hock et al. |
6896652 |
May 2005 |
Alferness et al. |
6902522 |
June 2005 |
Walsh et al. |
6902524 |
June 2005 |
Alferness et al. |
6997865 |
February 2006 |
Alferness et al. |
7022064 |
April 2006 |
Alferness et al. |
7025719 |
April 2006 |
Alferness et al. |
7077862 |
July 2006 |
Vidlund et al. |
7112219 |
September 2006 |
Vidlund |
7276022 |
October 2007 |
Lau et al. |
7468029 |
December 2008 |
Robertson |
2001/0016675 |
August 2001 |
Mortier et al. |
2001/0025171 |
September 2001 |
Mortier et al. |
2002/0029080 |
March 2002 |
Mortier et al. |
2002/0058855 |
May 2002 |
Schweich, Jr. et al. |
2002/0068849 |
June 2002 |
Schweich, Jr. et al. |
2002/0068850 |
June 2002 |
Vanden Hoek et al. |
2002/0077524 |
June 2002 |
Schweich, Jr. et al. |
2002/0147406 |
October 2002 |
Von Segesser |
2002/0169358 |
November 2002 |
Mortier et al. |
2002/0169359 |
November 2002 |
McCarthy et al. |
2002/0169360 |
November 2002 |
Taylor et al. |
2002/0173694 |
November 2002 |
Mortier et al. |
2003/0032979 |
February 2003 |
Mortier et al. |
2003/0050529 |
March 2003 |
Vidlund et al. |
2003/0065248 |
April 2003 |
Lau et al. |
2003/0088149 |
May 2003 |
Raman et al. |
2003/0130731 |
July 2003 |
Vidlund et al. |
2003/0166992 |
September 2003 |
Schweich, Jr. et al. |
2003/0171641 |
September 2003 |
Schweich, Jr. et al. |
2003/0181928 |
September 2003 |
Vidlund et al. |
2003/0229265 |
December 2003 |
Girard |
2003/0233023 |
December 2003 |
Khaghani et al. |
2004/0002626 |
January 2004 |
Feld et al. |
2004/0010180 |
January 2004 |
Scorvo |
2004/0034272 |
February 2004 |
Diaz et al. |
2004/0064014 |
April 2004 |
Melvin |
2004/0127983 |
July 2004 |
Mortier et al. |
2004/0133062 |
July 2004 |
Pai et al. |
2004/0133063 |
July 2004 |
McCarthy et al. |
2004/0147805 |
July 2004 |
Lau et al. |
2004/0147965 |
July 2004 |
Berger |
2004/0167374 |
August 2004 |
Schweich et al. |
2004/0181118 |
September 2004 |
Kochamba |
2004/0181120 |
September 2004 |
Kochamba |
2004/0181124 |
September 2004 |
Alferness |
2004/0186342 |
September 2004 |
Vanden Hock et al. |
2004/0210104 |
October 2004 |
Lau et al. |
2004/0215308 |
October 2004 |
Bardy et al. |
2004/0225304 |
November 2004 |
Vidlund et al. |
2004/0243229 |
December 2004 |
Vidlund et al. |
2004/0249242 |
December 2004 |
Lau et al. |
2004/0267083 |
December 2004 |
McCarthy et al. |
2004/0267329 |
December 2004 |
Raman et al. |
2005/0004428 |
January 2005 |
Cox et al. |
2005/0010079 |
January 2005 |
Bertolero et al. |
2005/0014992 |
January 2005 |
Lilip et al. |
2005/0020874 |
January 2005 |
Lau et al. |
2005/0033109 |
February 2005 |
Lau et al. |
2005/0038316 |
February 2005 |
Taylor |
2005/0054892 |
March 2005 |
Lau et al. |
2005/0058853 |
March 2005 |
Kochambe |
2005/0059854 |
March 2005 |
Hoek et al. |
2005/0065396 |
March 2005 |
Mortier et al. |
2005/0075723 |
April 2005 |
Schroeder et al. |
2005/0085688 |
April 2005 |
Girard et al. |
2005/0090707 |
April 2005 |
Lau et al. |
2005/0133941 |
June 2005 |
Schuhmacher |
2005/0171589 |
August 2005 |
Lau et al. |
2005/0192474 |
September 2005 |
Vanden Hoek et al. |
2005/0283042 |
December 2005 |
Meyer et al. |
2006/0063970 |
March 2006 |
Raman et al. |
2007/0043416 |
February 2007 |
Callas et al. |
2008/0064917 |
March 2008 |
Bar et al. |
|
Foreign Patent Documents
|
|
|
|
|
|
|
WO98/14136 |
|
Apr 1998 |
|
WO |
|
WO9814136 |
|
Apr 1998 |
|
WO |
|
WO 1999/44534 |
|
Sep 1999 |
|
WO |
|
WO9852470 |
|
Oct 1999 |
|
WO |
|
WO9952471 |
|
Oct 1999 |
|
WO |
|
WO 2000/06027 |
|
Feb 2000 |
|
WO |
|
WO 2000/06028 |
|
Feb 2000 |
|
WO |
|
WO0028912 |
|
May 2000 |
|
WO |
|
WO0028918 |
|
May 2000 |
|
WO |
|
WO0103608 |
|
Jan 2001 |
|
WO |
|
WO0110421 |
|
Feb 2001 |
|
WO |
|
WO0191667 |
|
Dec 2001 |
|
WO |
|
WO0195830 |
|
Dec 2001 |
|
WO |
|
WO0213726 |
|
Feb 2002 |
|
WO |
|
WO02000099 |
|
Sep 2002 |
|
WO |
|
WO03022131 |
|
Mar 2003 |
|
WO |
|
WO 2004/043265 |
|
May 2004 |
|
WO |
|
Other References
Bolling,et al., "Intermediate-Term Outcome of Mitral Reconstruction
in Cardiomyopathy", J. Thorac. Cardiovasc. Sur., vol. 115:2 (381-8)
Feb. 1998. cited by applicant .
Bourge, "Clinical Trial Begins for Innovative Device-Altering Left
Ventricular Shape in Heart Failure", UAB Insight,
http://www.health.uab.edu/show, posted Aug. 8, 2002. cited by
applicant .
Ghanta, et al., "Cardiovascular Surgery: Adjustable, Physiological
Ventricular Restraint Improves Left Ventricular Mechanics and
Reduces Dilation in an Ovine Model of Chronic Heart Failure,"
Circulation, JAHA, 2007, vol. 115 (1201-10). cited by applicant
.
Hung, et al., "Persistent Reduction of Ischemic Mitral
Regurgitation by Papillary Muscle Repositioning: Structural
Stabilization of the Pipillary Muscle Ventricular Wall Complex,"
Circulation, JAHA, 2007, vol. 116 (I-259 I-263). cited by applicant
.
Lamas, et al., "Clinical Significance of Mitral Regurgitation After
Acute Myocardial Infarction", Circulation--JAHA, vol. 96:3 (827-33)
Aug. 5, 1997. cited by applicant .
Liel-Cohen, et al., "Design of a New Surgical Approach for
Ventricular Remodeling to Relieve Ischemic Mitral Regurgitation,"
Circulation 2000, vol. 101(2756-63). cited by applicant .
Pai, et al., "Valvular Egurgitation," Clinical Science 2000,
Abstracts 1800-1804. cited by applicant .
Timek, et al., "Pathogenesis of Mitral Regurgitation in Tachycaria
Induced Cardiomyopathy," Circulation--JAHA, 2001, 104 (I-47 I-53).
cited by applicant .
Lei-Cohen, et al., "Design of a New Surgical Approach for
Ventricular Remodeling to Relieve Ischemic Mitral Regurgitation,"
Circulation Jun. 13, 2000, vol. 101, pp. 2756-2763. cited by
applicant.
|
Primary Examiner: Jastrzab; Jeffrey R
Attorney, Agent or Firm: Fish & Richardson P.C.
Claims
What is claimed is:
1. An external heart device, comprising: (a) a band dimensioned to
be received around a patient's heart, the band comprising an inner
layer and an outer layer, wherein some but not all areas of the
inner layer and outer layer are bound to one another; .[.and.]. (b)
at least .[.two.]. .Iadd.three .Iaddend.fillable chambers in the
band, the at least .[.two.]. .Iadd.three .Iaddend.fillable chambers
being spaced apart from one another and located in areas where the
inner layer and the outer layer are not bound to one another,
.[.the.]. at least two .Iadd.of the at least three
.Iaddend.fillable chambers being separated by a gap, wherein the
gap and each of the at least .[.two.]. .Iadd.three
.Iaddend.fillable chambers have a circumferential length, and
wherein the circumferential length of the gap is greater than the
circumferential length of each of the at least .[.two.].
.Iadd.three .Iaddend.fillable chambers; .Iadd.and (c) a filling
tube associated with each of said fillable chambers, wherein each
of said fillable chambers is configured and arranged to be
selectively individually filled, via an associated one of said
filling tubes, whereby three different ones of said fillable
chambers can be selectively filled to three different levels,
respectively,.Iaddend. wherein the at least .[.two.]. .Iadd.three
.Iaddend.fillable chambers are positioned on the heart spaced apart
from one another with the gap being placed over heart vasculature
so as to form a pressure-reducing bridge over the heart vasculature
contacting and applying constant localized pressure to the heart in
a predetermined location to modify a heart valve shape when the at
least .[.two.]. .Iadd.three .Iaddend.fillable chambers are
filled.
2. The external heart device of claim 1, wherein the at least
.[.two.]. .Iadd.three .Iaddend.fillable chambers are formed into
the areas where the inner layer and the outer layer are not bound
to one another.
3. The external heart device of claim 1, wherein the at least
.[.two.]. .Iadd.three .Iaddend.fillable chambers are inserted into
the areas where the inner layer and the outer layer are not bound
to one another.
4. The external heart device of claim 1, wherein the band is
transparent.
5. The external heart device of claim 1, wherein the band is made
of silicone rubber.
6. The external heart device of claim 1, wherein the inner layer
and outer layer are bound to one another by adhesives.
7. The external heart device of claim 1, wherein the inner layer
and outer layer are bound to one another by crosslinking.
8. The external heart device of claim 1, wherein the inner layer
and outer layer are bound to one another by stitching.
9. The external heart device of claim 1, wherein an interior
surface of the inner layer is textured.
10. The external heart device of claim 1, wherein the at least
.[.two.]. .Iadd.three .Iaddend.fillable chambers are a plurality of
fillable chambers.
11. The external heart device of claim 10, wherein two of the
plurality of fillable chambers are positioned spaced apart from one
another, and wherein the band forms a bridge therebetween.
12. The external heart device of claim 11, wherein the bridge in
the band is dimensioned to be positioned over vasculature on the
exterior of the heart when at least one of the plurality of
fillable chambers is filled.
13. The external heart device of claim 10, wherein the plurality of
fillable chambers is five fillable chambers.
14. The external heart device of claim 1, further comprising a
filling tube in fluid communication with the at least .[.two.].
.Iadd.three .Iaddend.fillable chambers.
15. The external heart device of claim 14, wherein the filling tube
is fillable through a blunt needle port.
16. The external heart device of claim 14, wherein the filling tube
is fillable through a sharp needle port.
17. The external heart device of claim 14, wherein the filling tube
is fillable through a subcutaneous port.
18. The external heart device of claim 14, wherein the filling tube
is made of silicone.
19. The external heart device of claim 14, wherein the filling tube
comprises identifying indicia.
20. .[.The external heart device of claim 17,.]. .Iadd.An external
heart device, comprising: (a) a band dimensioned to be received
around a patient's heart, the band comprising an inner layer and an
outer layer, wherein some but not all areas of the inner layer and
outer layer are bound to one another; (b) at least two fillable
chambers in the band, the at least two fillable chambers being
spaced apart from one another and located in areas where the inner
layer and the outer layer are not bound to one another, the at
least two fillable chambers being separated by a gap, wherein the
gap and each of the at least two fillable chambers have a
circumferential length, and wherein the circumferential length of
the gap is greater than the circumferential length of each of the
at least two fillable chambers; and (c) a filling tube associated
with each of said fillable chambers, wherein each of said fillable
chambers is configured and arranged to be selectively individually
filled, via an associated one of said filling tubes, whereby
different ones of said fillable chambers can be filled to different
levels,.Iaddend. wherein the at least two fillable chambers
comprises a plurality of fillable chambers and wherein .[.a.].
.Iadd.one of the .Iaddend.filling .[.tube.]. .Iadd.tubes
.Iaddend.is in fluid communication with each fillable chamber, and
wherein each filling tube is fillable through a subcutaneous port,
and wherein the plurality of subcutaneous ports are disposed on a
sheet.Iadd., and wherein the at least two fillable chambers are
positioned on the heart spaced apart from one another with the gap
being placed over heart vasculature so as to form a
pressure-reducing bridge over the heart vasculature contacting and
applying constant localized pressure to the heart in a
predetermined location to modify a heart valve shape when the at
least two fillable chambers are filled.Iaddend..
21. The external heart device of claim 20, wherein the sheet is
made of silicone or polyester.
22. The external heart device of claim 1, wherein the at least
.[.two.]. .Iadd.three .Iaddend.fillable chambers are filled by
saline.
23. The external heart device of claim 1, wherein the at least
.[.two.]. .Iadd.three .Iaddend.fillable chambers are filled by a
hardening polymer.
24. The external heart device of claim 1, wherein the at least
.[.two.]. .Iadd.three .Iaddend.fillable chambers are filled by a
gas.
25. The external heart device of claim 1, wherein the at least
.[.two.]. .Iadd.three .Iaddend.fillable chambers are filled by a
gel.
26. The external heart device of claim 1, further comprising at
least one sleeve positioned around an exterior surface of the outer
layer.
27. The external heart device of claim 26, wherein the at least one
sleeve is made of polyester.
28. A method of modifying heart valve function, comprising: placing
a band around a patient's heart, the band comprising an inner layer
and an outer layer, wherein areas of the inner layer and outer
layer are bound to one another, and wherein at least two fillable
chambers in the band are spaced apart from each other and are
located in areas where the inner layer and the outer layer are not
bound to one another.Iadd., .Iaddend.the at least two fillable
chambers being separated by a gap, wherein the gap and each of the
at least two fillable chambers have a circumferential length, the
circumferential length of the gap being greater than the
circumferential length of each of the at least two fillable
chambers, the at least two fillable chambers positioned on the
heart spaced apart from one another with the gap placed over heart
vasculature to form a pressure-reducing bridge over the heart
vasculature; and filling the at least two fillable chambers with a
fluid to cause the at least two fillable chambers to contact and
apply constant localized pressure to the heart in a predetermined
location to modify .Iadd.the shape of a single .Iaddend.heart valve
.[.shape.]..Iadd.; wherein said step of filling the at least two
fillable chambers comprises filling a first one of said fillable
chambers to a first level and filling a second one of said fillable
chambers to a second level, wherein said first level is different
from said second level.Iaddend..
.Iadd.29. An external heart device, comprising: (a) a band
dimensioned to be received around a patient's heart, the band
comprising an inner layer and an outer layer, wherein some but not
all areas of the inner layer and outer layer are bound to one
another; (b) at least two fillable chambers in the band, the at
least two fillable chambers being spaced apart from one another and
located in areas where the inner layer and the outer layer are not
bound to one another, the at least two fillable chambers being
separated by a gap, wherein the gap and each of the at least two
fillable chambers have a circumferential length, and wherein the
circumferential length of the gap is greater than the
circumferential length of each of the at least two fillable
chambers; (c) a filling tube associated with each of said fillable
chambers, wherein each of said fillable chambers is configured and
arranged to be selectively individually filled, via an associated
one of said filling tubes, whereby different ones of said fillable
chambers can be filled to different levels; and (d) an additional
outer layer positioned outwardly of the filling tubes, wherein said
additional outer layer is bound to the outer layer of the band,
thereby resulting in the band including the inner layer located
inwardly of the filling tubes and both the outer layer and the
additional outer layer being located outwardly of the filling
tubes, wherein the at least two fillable chambers are positioned on
the heart spaced apart from one another with the gap being placed
over heart vasculature so as to form a pressure-reducing bridge
over the heart vasculature contacting and applying constant
localized pressure to the heart in a predetermined location to
modify a heart valve shape when the at least two fillable chambers
are filled..Iaddend.
.Iadd.30. The external heart device of claim 29, further comprising
a tube bonding tab associated with each of the filling tubes,
whereby the tube bonding tabs are bonded to an outer surface the
inner layer of the band..Iaddend.
.Iadd.31. The external heart device of claim 29, wherein the
additional outer layer includes sections removed therefrom, wherein
each of the removed sections corresponds to one of the fillable
chambers..Iaddend.
.Iadd.32. The external heart device of claim 29, wherein the
additional outer layer includes sections removed therefrom, wherein
each of the removed sections defines a pocket between the inner
layer and the outer layer, and further wherein the pockets each
form one of the fillable chambers..Iaddend.
.Iadd.33. The method of claim 28, wherein the band further
comprises a filling tube associated with each of said fillable
chambers; and an additional outer layer positioned outwardly of the
filling tubes, wherein said additional outer layer is bound to the
outer layer of the band, thereby resulting in the band including
the inner layer located inwardly of the filling tubes and both the
outer layer and the additional outer layer being located outwardly
of the filling tubes, and further wherein said step of filling the
at least two fillable chambers comprises passing the fluid through
at least two of the filling tubes and into the at least two
associated fillable chambers..Iaddend.
.Iadd.34. The external heart device of claim 1, wherein each of
said filling tubes is fillable through a subcutaneous
port..Iaddend.
.Iadd.35. The external heart device of claim 34, wherein a
plurality of said subcutaneous ports are disposed on a
sheet..Iaddend.
.Iadd.36. The method of claim 28, wherein the band includes at
least three fillable chambers, and further wherein said step of
filling the fillable chambers comprises filling a first one of said
fillable chambers and a second one of said fillable chambers,
without filling a third one of said fillable chambers..Iaddend.
.Iadd.37. An external heart device, comprising: (a) a band
dimensioned to be received around a patient's heart, the band
comprising an inner layer and an outer layer, wherein some but not
all areas of the inner layer and outer layer are bound to one
another; (b) at least two fillable chambers in the band, the at
least two fillable chambers being spaced apart from one another and
located in areas where the inner layer and the outer layer are not
bound to one another, the at least two fillable chambers being
separated by a gap, wherein the gap and each of the at least two
fillable chambers have a circumferential length, and wherein the
circumferential length of the gap is greater than the
circumferential length of each of the at least two fillable
chambers; (c) a filling tube associated with each of said fillable
chambers, wherein each of said fillable chambers is configured and
arranged to be selectively individually filled, via an associated
one of said filling tubes, whereby different ones of said fillable
chambers can be filled to different levels; and (d) a port in fluid
communication with each of said filling tubes that is configured
and arranged to enable filling and deflating an associated one of
said fillable chambers, wherein at least one of said ports is of a
different type than the remainder of said ports, and wherein the at
least two fillable chambers are positioned on the heart spaced
apart from one another with the gap being placed over heart
vasculature so as to form a pressure-reducing bridge over the heart
vasculature contacting and applying constant localized pressure to
the heart in a predetermined location to modify a heart valve shape
when the at least two fillable chambers are filled..Iaddend.
.Iadd.38. The external heart device of claim 37, wherein the type
of each of said ports is selected from the group consisting of a
blunt needle port, a sharp needle port, a subcutaneous port, and a
Luer port..Iaddend.
.Iadd.39. An external heart device, comprising: (a) a band
dimensioned to be received around a patient's heart, the band
comprising an inner layer and an outer layer, wherein some but not
all areas of the inner layer and outer layer are bound to one
another; (b) at least two fillable chambers in the band, the at
least two fillable chambers being spaced apart from one another and
located in areas where the inner layer and the outer layer are not
bound to one another, the at least two fillable chambers being
separated by a gap, wherein the gap and each of the at least two
fillable chambers have a circumferential length, and wherein the
circumferential length of the gap is greater than the
circumferential length of each of the at least two fillable
chambers; (c) a filling tube associated with each of said fillable
chambers, wherein each of said fillable chambers is configured and
arranged to be selectively individually filled, via an associated
one of said filling tubes, whereby different ones of said fillable
chambers can be filled to different levels; and (d) a port in fluid
communication with each of said filling tubes that is configured
and arranged to enable filling and deflating an associated one of
said fillable chambers, wherein all but one of said ports comprise
subcutaneous ports, and wherein the at least two fillable chambers
are positioned on the heart spaced apart from one another with the
gap being placed over heart vasculature so as to form a
pressure-reducing bridge over the heart vasculature contacting and
applying constant localized pressure to the heart in a
predetermined location to modify a heart valve shape when the at
least two fillable chambers are filled..Iaddend.
.Iadd.40. The external heart device of claim 39, wherein said port
that is not a subcutaneous port comprises a blunt needle
port..Iaddend.
.Iadd.41. A method of modifying heart valve function, comprising:
placing a band around a patient's heart, the band comprising an
inner layer and an outer layer, wherein areas of the inner layer
and outer layer are bound to one another, and wherein at least two
fillable chambers in the band are spaced apart from each other and
are located in areas where the inner layer and the outer layer are
not bound to one another, the at least two fillable chambers being
separated by a gap, wherein the gap and each of the at least two
fillable chambers have a circumferential length, the
circumferential length of the gap being greater than the
circumferential length of each of the at least two fillable
chambers, the at least two fillable chambers positioned on the
heart spaced apart from one another with the gap placed over heart
vasculature to form a pressure-reducing bridge over the heart
vasculature; and filling the at least two fillable chambers with a
fluid to cause the at least two fillable chambers to contact and
apply constant localized pressure to the heart in a predetermined
location to modify heart valve shape, wherein said step of filling
the at least two fillable chambers comprises filling a first one of
said fillable chambers to a first level and filling a second one of
said fillable chambers to a second level, wherein said first level
is different from said second level, wherein said step of filling
the at least two fillable chambers comprises filling the first one
of said fillable chambers to the first level via a first type of
port and filling the second one of said fillable chambers to the
second level via a second type of port, and wherein said first type
of port is different from said second type of port..Iaddend.
.Iadd.42. The method of claim 41, wherein said second type of port
is configured and arranged to allow for post-operative changes to
the fluid level of the associated fillable chamber, while said
first type of port is not configured and arranged to allow for
post-operative changes to the fluid level of the associated
fillable chamber..Iaddend.
.Iadd.43. The method of claim 42, wherein said first type of port
comprises a blunt needle port..Iaddend.
.Iadd.44. The method of claim 42, wherein said second type of port
comprises a subcutaneous port..Iaddend.
.Iadd.45. An external heart device, comprising: (a) a band
dimensioned to be received around a patient's heart, the band
comprising an inner layer and an outer layer, wherein some but not
all areas of the inner layer and outer layer are bound to one
another; (b) at least two fillable chambers in the band, the at
least two fillable chambers being spaced apart from one another and
located in areas where the inner layer and the outer layer are not
bound to one another, the at least two fillable chambers being
separated by a gap, wherein the gap and each of the at least two
fillable chambers have a circumferential length, and wherein the
circumferential length of the gap is greater than the
circumferential length of each of the at least two fillable
chambers; (c) a filling tube associated with each of said fillable
chambers, wherein each of said fillable chambers is configured and
arranged to be selectively individually filled, via an associated
one of said fillable tubes, whereby different ones of said fillable
chambers can be filled to different fluid levels; (d) an additional
outer layer positioned outwardly of the filling tubes, wherein said
additional outer layer is bound to the outer layer of the band,
thereby resulting in the band including the inner layer located
inwardly of the filling tubes and both the outer layer and the
additional outer layer being located outwardly of the filling
tubes; and (e) a port in fluid communication with each of said
filling tubes that is configured and arranged to enable filling and
deflating an associated one of said fillable chambers, wherein at
least one of said ports is of a different type than the remainder
of said ports; wherein the at least two fillable chambers are
positioned on the heart spaced apart from one another with the gap
being placed over heart vasculature so as to form a
pressure-reducing bridge over the heart vasculature contacting and
applying constant localized pressure to the heart in a
predetermined location to modify a heart valve shape when the at
least two fillable chambers are filled..Iaddend.
.Iadd.46. The external heart device of claim 45, wherein all but
one of said ports is of a first type and the single remaining port
is of a second type, wherein said first type is different from said
second type..Iaddend.
.Iadd.47. The external heart device of claim 45, wherein: at least
one of said ports is of a first type and the remainder of said
ports are of a second type; said first type is different from said
second type; and said second type of port is configured and
arranged to allow for post-operative changes to the fluid level of
the associated fillable chamber, while said first type of port is
not configured and arranged to allow for post-operative changes to
the fluid level of the associated fillable chamber..Iaddend.
.Iadd.48. The external heart device of claim 45, wherein: said
first type of port is a blunt needle port; and said second type of
port is selected from the group consisting of a sharp needle port,
a subcutaneous port, and a Luer port..Iaddend.
Description
TECHNICAL FIELD
The present invention relates to devices and methods for treating
dilatation of heart valves by applying localized pressure to
surface areas of the heart.
BACKGROUND OF THE INVENTION
Dilatation of the base of the heart occurs with various diseases of
the heart and often is a causative mechanism of heart failure. In
some instances, depending on the cause, the dilatation may be
localized to one portion of the base of the heart (e.g., mitral
insufficiency as a consequence of a heart attack affecting the
inferior and basal wall of the left ventricle of the heart),
thereby affecting the valve in that region. In other cases, such as
cardiomyopathy, the condition may be global affecting more of the
heart and its base, causing leakage of particularly the mitral and
tricuspid valves. Other conditions exist where the mitral valve
structure is abnormal, predisposing to leakage and progressive
dilatation of the valve annulus (area of valve attachment to the
heart). This reduces the amount of blood being pumped out by the
ventricles of the heart, thereby impairing cardiac function
further.
In patients with heart failure and severe mitral insufficiency,
good results have been achieved by aggressively repairing mitral
and/or tricuspid valves directly, which requires open-heart surgery
(Bolling, et al). The mitral valve annulus is reinforced internally
by a variety of prosthetic rings (Duran Ring, Medtronic Inc) or
bands (Cosgrove-Edwards Annuloplasty Band, Edwards Lifesciences
Inc). The present paradigm of mitral valve reconstruction is
therefore repair from inside the heart, with the annulus being
buttressed or reinforced by the implantation of a prosthetic band
or ring. Since this is major open-heart surgery with intra-cavitary
reconstruction, there is the attendant risk of complications and
death associated with mitral valve surgery. Another approach has
been to replace the mitral valve, which while addressing the
problem, also requires open-heart surgery and involves implantation
of a bulky artificial, prosthetic valve with all its consequences.
Because every decision to perform major surgery requires some risk
vs. benefit consideration, patients get referred for risky surgery
only when they are significantly symptomatic or their mitral valve
is leaking severely.
In contrast to the more invasive approaches discussed above, in
specific instances of inferior left ventricular wall scarring
causing mitral regurgitation, Liel-Cohen and co-workers have
suggested localized pressure or support of the bulging scar of the
inferior wall of the heart from the outside (Liel-Cohen. N. et al.
(2000) "Design of a new surgical approach for ventricular
remodeling to relieve ischemic mitral regurgitation: insights from
3-dimensional echocardiography". Circulation 101
(23):2756-2763).
Another less invasive approach to preventing global heart dilation
is ventricular containment with a custom made polyester mesh, or
cardiac support device (U.S. Pat. Nos. 6,077,218 and 6,123,662).
These devices are designed to provide a passive constraint around
both ventricles of the heart, and constrain diastolic expansion of
the heart. Other devices include ventricular assist devices that
provide cardiac assistance during systole and dynamic ventricular
reduction devices that actively reduce the size of the heart.
However, this technique does not specifically address valve leakage
using a device that reinforces the base of the heart in all phases
of the cardiac cycle.
Percutaneous approaches (including "edge-to-edge", placating the
annulus and coronary sinus approaches) of accessing the heart
through the femoral artery have been used. Disadvantages of
percutaneous approaches include fixture-made-clots being sent
downstream, and the dangers of potential patient allergy to
contrast media. In addition, percutaneous approaches require
complicated systems and are very dependent on the anatomy of the
patient. As a result these systems require the help of an
experienced and trained interventional cardiologist to assist with
the procedure.
An example of a system that provides a less invasive approach to
base stabilization is found in U.S. Pat. No. 6,716,158 to Raman et.
al. However, although the Raman et. al. system operates to
stabilize the base of the heart, it does not provide a system to
modulate or modify heart valve function by applying localized
pressure to particular regions of the heart, for example, to
tissues adjacent to heart valve. Such a system would advantageously
apply inward pressure to tissue adjacent to the heart valves so as
to modify the shape or reduce the size of a heart valve itself.
Accordingly, there is a need to non-invasively repair or
re-configure the shape of a mitral and/or tricuspid valve so as to
treat valve dilation and resulting valve insufficiency
problems.
The present invention is directed to solving the above mentioned
problems and can advantageously be applied to both patient
populations requiring heart valve modification by applying
localized pressure, and to patient populations simply requiring
external stabilization of the base of the heart.
SUMMARY OF THE INVENTION
The present invention addresses the problems discussed above by
providing a device for the treatment of certain heart disorders, in
particular mitral and/or tricuspid valve insufficiency. The device
aims to apply localized pressures to the heart and/or reduce the
size of the base of the heart that contains these valvular
structures. The device also provides a system for applying inward
pressure to tissue adjacent to the heart valves so as to shape the
mitral and/or tricuspid valve itself. In addition, the present
invention can be used to address progressive dilatation of any
localized area of the heart, such as the atrial or ventricular
myocardium, or the cardiac base. It does so by optionally providing
external re-enforcement or remodeling of the cardiac base while
still providing support of the valve at annular and sub-annular
levels. As used herein, the surgical procedure for implanting the
device is referred to as basal annuloplasty of the cardia
externally (BACE.TM.) and the device is referred to as the external
cardiac basal annuloplasty system BACE System.
An advantage of the present system is that it overcomes the
disadvantages of percutaneous approaches by overcoming the
disadvantages of systems accessing the heart through the femoral
artery.
Another advantage of the present invention is that it remodels the
heart while re-shaping the valve(s). As such, the present invention
operates to both prevent heart disease and to treat it as well. In
addition, in one embodiment of the present invention uniquely
incorporates the use of subcutaneous ports that allows adjustment
and post operative re-shaping of the valve(s) without making
incisions in the patient.
In one aspect, the present invention provides an external heart
device, comprising: a band dimensioned to be received around a
patient's heart, the band comprising an inner layer and an outer
layer, wherein areas of the inner layer and outer layer are bound
to one another; and at least one fillable chamber in the band, the
at least one fillable chamber being located in areas where the
inner layer and the outer layer are not bound to one another.
In various embodiments, the at least one fillable chamber may
either be formed or inserted into the areas where the inner layer
and the outer layer are not bound to one another, thereby providing
a band structure with one or more integral fillable chambers.
In various embodiments, the band may be transparent, and may
optionally be made of silicone rubber, or other suitable bio
compatible implantable material.
In various embodiments, the present invention may be formed with
the inner layer and outer layer being bound to one another by
adhesives, crosslinking, heat and/or pressure, or even by
stitching.
In various embodiments, the interior surface of the inner layer may
optionally be textured so as to remain in position around the
heart, yet still permit the device to be removed in future without
damaging the surface of the heart.
In various embodiments, the device has a plurality of fillable
chambers, with two of the fillable chambers being positioned spaced
apart from one another, and with the band forming a bridge portion
therebetween. Advantageously, the bridge portion in the band may be
dimensioned to be positioned over vasculature on the exterior of
the heart when at least one of the fillable chambers are
filled.
Advantageously as well, the dimensions of the fillable chambers and
their positioning in the band may also provide a system to apply
inward pressure to tissues adjacent to a heart valve so as to
modify or change the shape of the valve to a more desired shape. In
one exemplary application of the present invention, two of the
fillable chambers are positioned on opposite sides of a mitral
valve of the heart to shape the mitral valve to prevent mitral
valve dilation, and resulting mitral regurgitation.
In various embodiments, each of the fillable chambers has a filling
tube in fluid communication therewith. In different embodiments,
the filling tubes may optionally be fillable through a blunt needle
port, a sharp needle port, or through a subcutaneous port, Luer
port fitting, or various combinations thereof. In one exemplary
embodiment, all but one of the filling tubes are fillable through a
subcutaneous port, and the plurality of subcutaneous ports are
disposed together on a sheet. The sheet may optionally be made of
silicone or polyester or other suitable material and may be used to
position these subcutaneous ports at a convenient location within
the patient's body.
The filling tubes may optionally be made of silicone or other
suitable bio-implantable material. Depending upon the method of
manufacturing the present device, the individual filling tubes may
be integrally formed as the filling chambers of the device are
formed, or they may be inserted after the fillable chambers have
been formed.
In various embodiments and applications, the various fillable
chambers may be filled either by saline, a hardening polymer, a
gel, a gas, or other suitable material.
In optional embodiments, one or more sleeves may be positioned
around an exterior surface of the outer layer of the device. Such
sleeves may advantageously operate to hold the band at a preferred
location on the patient's heart. Specifically, such sleeves are
designed to promote tissue ingrowth to hold the device in place.
These sleeves may be made of polyester or other suitable materials.
In one exemplary embodiment, they are 5/8'' wide, however, the
present invention is not limited to any particular dimensions.
In one exemplary embodiment, the band may be between 2 and 5 cms
wide and may be secured by clips, sutures, or other fasteners, with
some on the posterior side and some on the anterior side of the
heart. Specific care is taken to avoid injury to the circumflex and
right coronary arteries and the coronary sinus. This procedure may
be performed either as a stand-alone procedure or as an adjunct to
other cardiac surgery. Additionally, it may be performed with or
without the aid of cardio-pulmonary bypass.
Optional variations of the device include a complete stabilization
of the base of the heart, or a partial stabilization around the
expansile portions of the mitral and tricuspid valves. It is to be
understood, however, that the present invention is not simply
directed to stabilizing the base of the heart. Instead, the present
invention is well suited to modifying heart valve function (and
optional valve re-shaping) by therapeutically applying localized
pressures to various regions of the heart.
Another variation seeks to use ports along the device that will
facilitate delivery of specialized drugs, gene therapeutic agents,
growth factors, etc.
A specific variation incorporates the use of epicardial
biventricular, and multi-site pacing electrodes implanted along
with the BACE-System, where multi-site pacing might be indicated.
One iteration has multiple electrodes arranged as an array along
the left and right ventricular walls of the heart, close to the
base of the heart. The option then exists to allow selection of
various sites along the heart to allow for optimal
resynchronisation or optimization of contractility.
The present invention also provides a method of implantation, which
may be through a conventional full median stemotomy with the strip
being secured by sutures, or a minimally invasive thoracotomy
approach whereby the device/strip may be folded/rolled and
implanted by a specialized implantation system and secured using
adhesives, self-firing clips, sutures, etc.
Another application of the device is the local application to
stabilize scars of the heart to prevent their expansion (local
ventricular stabilization).
BRIEF DESCRIPTION OF THE FIGURES
FIG. 1 depicts a cross-section of the heart, showing the
approximate location of a representative embodiment of the device
of the present invention by dashed lines, and the distance between
the top and the bottom of the heart represented by "X".
FIG. 2 depicts a cross-section of the base of the heart between the
dashed lines depicted in FIG. 1.
FIG. 3 is a perspective view of a representative embodiment of the
device of the present invention.
FIG. 4 is a side elevation view of the embodiment of the device of
FIG. 3.
FIG. 5 is a proximal end view of the embodiment of the device of
FIG. 3.
FIG. 6A is a perspective view of the device of FIG. 3, shown
received around a patient's heart, prior to filling of the fillable
chambers.
FIG. 6B is a perspective view of the device of FIG. 3, shown
received around a patient's heart, after filling of the fillable
chambers.
As depicted in FIGS. 7A to 7D, PV=pulmonary valve, MV=mitral valve,
AV=aortic valve and TV=tricuspid valve.
FIG. 7A depicts a cross-sectional schematic diagram of the base of
the heart showing the present invention prior to re-shaping the
mitral valve by filling chamber 30E.
FIG. 7B depicts a cross-sectional schematic diagram of the base of
the heart showing the present invention after re-shaping the mitral
valve by filling chamber 30E (i.e.: showing the band forming a
bridge portion between two of the fillable chambers 30A and 30B,
and showing the modification of the shape of a patient's mitral
valve to treat mitral dilation.)
FIG. 7C depicts a cross-sectional schematic diagram of the base of
the heart showing the present invention prior to re-shaping the
mitral valve by filling chamber 30D.
FIG. 7D depicts a cross-sectional schematic diagram of the base of
the heart showing the present invention after re-shaping the mitral
valve by filling chamber 30D (i.e., showing the band forming a
bridge portion between two of the fillable chambers 30A and 30B,
and showing the modification of the shape of a patient's mitral
valve to treat mitral dilation.)
FIG. 8 is a perspective view of a second representative embodiment
of the device of the present invention three sleeves received
around the band for attachment to the exterior of the heart.
FIG. 9 is an illustration of a first system for manufacturing the
present invention using three separate layers of material.
FIG. 10 is an illustration of a second system for manufacturing the
present invention using one layer of material folded on top of
itself with a second layer of material inserted therebetween.
FIG. 11 is an illustration of a third system for manufacturing the
present invention using one layer of material having regions that
are pinched onto itself to be bound together, showing the insertion
of filling tubes into the separate fillable-chambers.
FIG. 12 is an illustration of an alternate embodiment of the
invention having pockets in the device with fillable chambers
inserted therein.
FIG. 13 is an illustration of the blunt needle port used to fill
and deflate one or more fluid chambers.
DETAILED DESCRIPTION OF THE INVENTION
The present invention is directed to modifying heart valve function
by applying localized support or pressure to various regions of the
heart. In addition, the present invention may optionally be used to
decrease, and/or prevent increases in, the dimensions of the base,
and in particular the atrio-ventricular junction, beyond a
pre-determined size.
In particular procedures, the present invention is directed to
applying pressure to tissue adjacent to the mitral and/or tricuspid
heart valves. This has the effect of beneficially modifying the
shape of the heart valve(s) to treat heart valve dilation. As such,
this invention is particularly suited for use in regurgitation of
the mitral and tricuspid valves. However, the device may also
optionally be used prophylactically in heart failure surgery to
prevent further cardiac basal dilation or expansion even if the
underlying mitral and tricuspid valves are competent. As such, the
present device may be used in moderate or advanced heart failure to
prevent progression of basal dilation or reduce the size of the
dilated base.
As used herein, "atrio-ventricular" or A-V groove refers to the
junction between the atrial and ventricular chambers of the heart,
also known as the atrio-ventricular junction marked externally by
the atrio-ventricular groove. This is easily identified in the
change of appearance of the cardiac muscle and also the presence of
arteries and veins. The "cardiac base", as used herein, is the area
of the heart between and including the AV groove and extends to,
but not including, the bottom or apex of the heart.
The heart is enclosed within a double walled sac known as the
pericardium. The inner layer of the pericardial sac is the visceral
pericardium or epicardium. The outer layer of the pericardial sac
is the parietal pericardium. The term "endocardial surface" refers
to the inner walls of the heart. The term "epicardial surface"
refers to the outer walls of the heart.
The mitral and tricuspid valves sit at the base of the heart and
prevent blood from leaking back into the atria or collecting
chambers. See FIG. 1. Mitral regurgitation is a condition whereby
blood leaks back through the mitral valve into the left atrium.
Over time, this creates a damming of blood in the lungs causing
symptoms of shortness of breath. The left heart particularly the
left ventricle has to pump a greater volume of blood as a result
causing greater strain on this chamber.
Dilatation of the mitral annulus occurs maximally in the posterior
portion of the annulus, which is not supported by the cardiac
fibro-skeleton. FIG. 2 is an anatomic diagram of the base of the
heart, showing the valves and the structures in contact with them.
FIGS. 7A to 7D are various corresponding schematic representations
of the valves at the cardiac base during placement and operation of
the present device.
Mitral valve repair or replacement at present is always performed
from inside the heart with the aid of cardiopulmonary bypass. Rings
are implanted along the inner surfaces of the entire or expansile
portions of the mitral and tricuspid annuli. Alternatively, when
mitral valve malfunction is severe, replacement of the valve with a
prosthetic valve may be indicated.
Overview
The basal ventricular stabilization, and heart valve shape
re-shaping of the present invention works by using a band of
prosthetic material such as silicone rubber being anchored or
sutured to the base of the heart at the level of the
atrio-ventricular groove. This band has at least one integral
fillable chambers formed or inserted therein. In use, the present
device serves to stabilize the mitral and tricuspid annuli from the
outside (see FIGS. 7B and 7D). As will also be shown herein, this
also serves to provide a device that applies pressure to tissue
regions adjacent to the heart valves (e.g.: mitral and/or tricuspid
valves) to re-shape the heart valve itself as a method of treating
valve dilation problems.
The present invention and technique reduces the complexity of the
procedure and minimizes the invasive nature and complications from
work on the valve. This system and technique is of particular
benefit in patients that have morphologically normal valves with
annular dilatation. The device can be applied and anchored to the
cardiac base, with the heart beating, without the aid of
cardiopulmonary bypass.
Many patients with moderate degrees of mitral regurgitation are not
treated surgically, because the risks of surgery outweigh the
potential benefits in this group of patients. However, patients
with conditions such as chronic heart failure tend to get very
symptomatic even with moderate degrees of mitral regurgitation.
These groups of patients would benefit from the less invasive
procedures, which are the subject of the present invention. Thus,
the potential of this technique in treating mitral regurgitation as
a minimally invasive procedure has great appeal as the population
ages and more patients manifest with symptoms of heart failure. It
also can be applied in patients undergoing open heart coronary
artery surgery without the aid of a heart-lung machine.
Device Parameters
The device of the present invention can be constructed of any
suitable implantable material. In preferred embodiments, the device
is constructed from layers of silicone rubber. An advantage of
using such a material is that the device is sufficiently flexible
to move with the expansion and contraction of the heart without
impairing its function. It should, however, be designed to prevent
expansion of the cardiac base during diastolic filling of the heart
to a predetermined size. Since the size expansion parameters of a
beating heart are well known, this can be accomplished by testing
the device in vitro by applying forces that mimic heart
expansion.
As shown in FIG. 3, in one embodiment, the device 10 comprises a
band 20 dimensioned to be received around a patient's heart. Band
20 comprises an inner layer 22 and an outer layer 24. In accordance
with the present invention, areas of inner layer 22 and outer layer
24 are bound to one another, resulting in a very thin system design
as can be seen. A unique advantage of such a thin band 20 is that
it can easily be placed around the patient's heart during
surgery.
Band 20 further comprises at least one fillable chamber 30
integrally formed therein. As depicted in FIG. 3, the band
comprises five fillable chambers 30A-E. Specifically, fillable
chambers 30 are located in areas where inner layer 22 and the outer
layer 24 are not bound to one another. As will be fully explained
below, fillable chambers 30 may be integrally formed into band 20
when inner layer 22 and outer layer 24 are selectively bound
together to create an enclosure. Alternatively, however, fillable
chambers 104 may be separately constructed and inserted into the
areas where inner layer 22 and outer layer 24 are not bound to one
another in the manufacturing of device 100 as seen in FIG. 12. For
example, fillable chambers 104 may be inserted into individual
"pockets" formed between inner layer 22 and outer layer 24. These
pockets may be formed by attaching inner layer 22 and outer layer
24 along two sides and a first edge, keeping the second opposite
edge (and the interior of the pocket) unbound until the individual
chambers are inserted. The pocket openings would then be bonded
closed or other means would be used to secure the individual
fillable chambers.
In one exemplary embodiment, band 20 is formed from silicone rubber
and is therefore transparent. However, the present invention is not
so limited. For example, it is to be understood that band 20 may
also be formed from other suitable biocompatible implantable
materials, including, but not limited to a textile made from
polyester, PTFE (polytetrafluoroethylene), or elastic yarns.
An advantage of forming band 20 (and its fillable chambers 30) from
a transparent material is that it facilitates placement of the
device around the patient's heart. In particular, the external
vasculature of the heart is clearly viewable through band 20 as
band 20 is placed around the patient's heart. Moreover, the
transparent nature of the material permits easy positioning of
fillable chambers 30 at preferred locations adjacent to heart
valves (e.g., the mitral and/or tricuspid valve), and away from the
vasculature.
In various embodiments, inner layer 22 and outer layer 24 may be
bound to one another by adhesives, crosslinking (e.g., when layers
22 and 24 are pressed together and heated), or even by stitching.
It is therefore to be understood that the present invention is not
limited to any particular system of attachment or bonding of layers
22 and 24 together.
In various optional embodiments, an interior surface of inner layer
22 may be textured. This may advantageously assist in holding band
20 at a preferred position on the patient's beating heart. It is
important, however, that the interior surface of inner layer 22 not
be so textured such that it would adhere too strongly to the
exterior of the heart, since this would make band 20 difficult to
remove.
As seen in FIGS. 4 and 5, band 20 preferably has a plurality of
fillable chambers 30. In FIG. 4, one such exemplary chamber 30 is
depicted. As illustrated in FIG. 5, band 20 has five fillable
chambers, being 30A, 30B, 30C, 30D and 30E. It is to be understood
that this is only one exemplary embodiment, and that other
embodiments of the invention have more or less than five fillable
chambers 30. As such, the present invention encompasses any
embodiment having at least one fillable chamber 30.
As also seen in FIG. 5, two of the plurality of fillable chambers
30 may be positioned spaced apart from one another, such that band
20 has a gap 21 between chambers 30A and 30B as depicted which
forms a bridge between the chambers when applied to a patient's
heart. Preferably, band 20 and fillable chambers 30A and 30B are
dimensioned such that the gap 21 is dimensioned to be positioned
over vasculature on the exterior of the heart when fillable
chambers 30A and 30B are filled thus forming a bridge therebetween.
Thus, fillable chambers 30A and 30B can be positioned on opposite
sides of the pulmonary trunk of the heart. Bridges can also be
formed between 30B and 30C, 30C and 30D, and 30D and 30E. An
important advantage of these bridges is that they do not need to
form a space between the heart and the band. Instead, they only
need to reduce localized pressure so as to prevent vascular
occlusion. A bridge or release of pressure can also be formed by
filling only one chamber. Filling only one chamber creates pressure
directly under that chamber, but it also relieves pressure directly
on each side of that chamber.
As also seen in FIGS. 3 to 5, a number of filling tubes 40 are
provided. Filling tubes 40 are preferably each in fluid
communication with a separate fillable chamber 30, as illustrated
in FIGS. 3 and 5.
Filing tubes 40 may be made of silicone, or other suitable
material. Each filing tube 40 is in fluid communication with, and
fills, its own dedicated fillable chamber 30. For example, as
depicted in FIG. 5, filling tube 40A fills fillable chamber 30A,
etc. It is to be understood that the present invention is not
limited as to any particular substance being used for filing
fillable chambers 30. As such, the individual fillable chambers 30
may be filled with substances including, but not limited to, a
saline solution, a hardening polymer, a gel, or even a gas.
Moreover, it is also to be understood that different fillable
chambers 30 may be filled with different substances from one
another.
In various embodiments, the separate filling tubes 40 may be
fillable through a blunt needle port 44 (for receiving blunt
needle), a sharp needle port, or through a subcutaneous port. As
such, different filling tubes 40 may be fitted with different ports
at their proximal ends. For example, as shown in FIG. 6A, filling
tube 40A may be a short filling tube specifically equipped for
filling through a blunt needle port. As such, filling tube 40A can
be filled by a syringe via a syringe tip with a blunt needle as
depicted in FIGS. 6A and 6B.
The present device is initially presented to the surgeon as a
flattened, flexible device that is easy to handle during an
operation.
FIGS. 6A and 6B show perspective views of the present device 10,
with the band 20 as positioned around the patient's heart, with the
fillable chambers unfilled (FIG. 6A) and filled (FIG. 6B).
As seen in FIGS. 6A and 6B, in one embodiment of the present
invention, device 10 comprises a band 20 having five fillable
chambers 30A to 30E, and with each fillable chamber having its own
dedicated filling tube 40A to 40E. As can also be seen, each of
filling tubes 40B to 40E are fillable through a subcutaneous port
42B to 42E. The subcutaneous port(s) provide a unique feature to
the invention with regards to heart valve repair in that they allow
a surgeon to make post-operative adjustments to the implant without
making any incisions. This is done by inserting a small gauge
needle into the subcutaneous ports and injecting or withdrawing
biocompatible fluid as needed. The subcutaneous port is made of
silicone rubber or other biocompatible material that can be
penetrated with a hypodermic needle and then reseal after removal
of the needle.
Each subcutaneous port also may optionally include a biocompatible
radiopaque metal drawn "can" 47 inside as depicted in FIG. 6B to
facilitate locating the port by tactile feedback on the needle and
syringe and by imaging on X-ray or fluoroscopy, which will also
allow the needle to engage the port without enentrating it
completely.
Optionally, subcutaneous ports 42B to 42E are disposed on a sheet
(not depicted). This sheet may be made of silicone or polyester, or
any other suitable material, or any combinations thereof. A sheet
has the advantage of holding subcutaneous ports 42B to 42E together
for convenient access. Preferably, the sheet (and subcutaneous
ports 42B to 42E attached thereto) is surgically positioned on the
lower side of the chest.
In preferred embodiments, each filing tube 40A to 40E may include a
unique marker or indicia 43 (as shown in FIGS. 6A and 6B) such that
the surgeon is able to clearly and easily identify which
subcutaneous port 42 corresponds to which particular fillable
chamber 30. For example, one radiopaque marker may be affixed to
filling tube 40A, two radiopaque markers may be affixed to filling
tube 40B, etc. Other versions of indicia in addition to radiopaque
markers are contemplated within the scope of the present
invention.
After band 20 has been positioned around the heart, saline may be
introduced first with a blunt needle through a blunt needle port of
filling tube 40A, and then through subcutaneous ports 42B to 42E to
thus fill fillable chambers 30A to 30E. Since fillable chambers 30A
to 30E can be selectively individually filled, it is possible for
the surgeon to adjust the fitting of band 20 on the patient's heart
with great accuracy. As such, each of fillable chambers 30A to 30E
can be filled to a desired level and placed around the heart such
that gap 21 and fillable chambers 30A to 30E are best positioned on
the patient's heart to reshape the patient's heart valves as
desired.
FIGS. 7A to 7D are cross sectional views of various of the devices
at the location shown by the arrows in FIG. 6A. As such, they are a
top-down cross sectional device immediately above the top edge of
the device, giving the chambers a "pillow shape" configuration,
with the closed edge of the "pillow" shown through the chambers 30.
However, as discussed elsewhere in the specification, the band 20
actually consists of a separate inner layer 22 and outer layer 24,
although not explicitly depicted in FIGS. 7A to 7D.
For example, as seen in FIGS. 7A and 7B, the shape of mitral valve
MV may be modified by the filling of fillable chamber 30E. (FIG. 7A
shows placement of the present band 20 prior to filling of fillable
chamber 30E. FIG. 7B shows placement of the present band 20 after
filling of fillable chamber 30E.). As can be seen, the poorly
sealing mitral valve MV shown in FIG. 7A is re-shaped to seal
properly in FIG. 7B. Chambers 30A and 30B as depicted in FIG. 7B
are not filled to a degree necessary to reshape the pulmonary valve
(PV), although they could be if such an effect was desired.
Alternatively, as seen in FIGS. 7C and 7D, the shape of mitral
valve MV may instead be modified by the filling of fillable chamber
30D. (FIG. 7C shows placement of the present device 20 prior to
filling of fillable chamber 30D. FIG. 7D shows placement of the
present device 20 after filling of fillable chamber 30D.). As can
be seen, the poorly sealing mitral valve MV shown in FIG. 7C is
reshaped to seal properly in FIG. 7D.
As can also be seen in FIGS. 7A through 7D, band 20 forms a bridge
corresponding to gap 21 between two of the fillable chambers, 30A
and 30B. (Similar bridges can also be formed in band 20 between
successive fillable chambers 30, or between a single fillable
chamber 30 and the portion of the band adjacent thereto.)
As can be seen, the thin nature of band 20, coupled with the
potentially large volumes of individually fillable chambers 30
produces a system in which pressure can be directed not only
radially inward towards the center of heart, but also a "pinching"
effect can be generated between adjacent fillable chambers 30.
As can be seen, by using different filling levels for each of the
different fillable chambers 30, a system is provided in which
pressures on the heart can be applied in an infinite number of
different directions, and amplitudes. As such, pressures may be
applied radially inwardly to the heart, as well as in non-radial
directions (i.e., "pinching") portions of the heart
therebetween.
FIG. 8 is a perspective view of a second representative embodiment
of the device of the present invention having a plurality of
ingrowth sleeves 50 received around band 20 for attachment to the
exterior of the heart. In use, sleeves 50 operate like belt loops
to hold up the band like a belt, thus holding band 20 in positions
against the patient's beating heart.
Sleeves 50 are positioned on an exterior surface (i.e., outer side)
of layer 24 as seen in FIG. 8. Sleeves 50 may optionally be made of
polyester, or any other suitable material, including, but not
limited to other woven, knitted, matted, or other textiles. Sleeves
50 in the preferred embodiment act as promoters of controlled
tissue growth such that they become secure to selected areas of the
heart, but they may also act to limit tissue growth and just
provide mechanical means of attachment. Sleeves 50 may optionally
be produced by molding them directly into a tension band. Sleeves
50 may optionally be fitted onto band 20 by sutures or staples.
FIGS. 9 to 11 show three different methods for producing the
present device 10, including band 20 with chamber(s) 30 and
optional filling tubes 40. It is to be understood that the device
of the present invention is not limited to devices made by any
particular system of manufacture. However, it is also to be
understood that the present invention includes a variety of novel
methods of manufacture of the device.
FIG. 9 is an illustration of a first system for manufacturing the
present invention using three layers of material. Specifically, the
view of FIG. 9 is an exploded view showing three layers of material
as sandwiched together to form the present invention.
In this method of making the invention, a first layer of material
(i.e.: layer 22) and a second layer of material (i.e. layer 24) are
provided. Layers 22 and 24 may optionally be made of vulcanized
silicone rubber, but may also be made of any other suitable
material. In various embodiments, layers 22 and 24 may be made of
the same materials, or be made of different materials. In addition,
layers 22 and 24 may be made to the same thickness, or be made to
different thicknesses.
A middle layer 25 is positioned between layers 22 and 24. Middle
layer 25 may be made of separate sections of non-cured or
non-vulanized silicon rubber. Middle layer 25 has sections removed
that define and correspond to the locations of fillable chambers
30. Specifically, the presence of removed sections in middle layer
sections 25 will allow layers 22 and 24 to contact one another (and
be bound together) in those regions where middle layer sections 25
are disposed.
In accordance with the present method, layers 22, 25, and 24 may be
bound together by applying pressure and heating such that they cure
and fuse together. Alternatively, layers 22 and 24 can be bound
directly together without 25 if they were non-vulcanized sheets of
silicone rubber and then crosslinked together when these two layers
are under pressure and heated at selective bond points.
As can be seen, the regions in which middle layer sections 25 are
not positioned will form "pockets" between layers 22 and 24 (since
middle layer 25 is not present which prevents layers 22 and 24 from
becoming bonded to one another). These "pockets" defined by removed
sections of middle layer 25 form the fillable chambers 30 in the
band.
As can also be seen in FIG. 9, the distal ends 41 of filling tubes
40 may be inserted into the removed sections in middle layer 25. As
a result, the distal ends 41 of filing tubes 40 are inserted within
fillable chambers 30, while the bonding of layers 22 and 24
together secure in position the remaining end portion of filing
tubes 40. A bonding tab 46 can be used to bind distal end 41 in
position against layer 22 if needed to form a fluid tight chamber
that communicates with tubing 40.
FIG. 10 is an illustration of a second system for manufacturing the
present invention using one layer of material folded on top of
itself with a second layer of material inserted therebetween.
In this second method of making the invention, a single layer of
material 23 is used to form both inner layer 22 and outer layer 24.
As can be seen, the single layer of material 23 is simply folded
over upon itself. An advantage of this particular method of
fabricating band 20 is that it avoids having to use two separate
materials to form layers 22 and 24. This method also eliminates the
creation of a seal all around the fillable chambers, so that
fillable chambers 30 might be larger.
The method forming the device in FIG. 10 is similar to that set
forth above with respect to forming the device of FIG. 9.
Specifically, layer 23 is bonded, fused, cross-linked or adhered
onto itself with removed sections in middle layer 25 forming the
resulting fillable chambers 30. Similarly as well, the distal ends
41 of filling tubes 40 may be inserted in the removed sections of
middle layer 25. As a result, the distal ends 41 of filing tubes 40
are inserted within fillable chambers 30, while the bonding of
layer 23 onto itself secures in position the remaining end portion
of filing tubes 40.
FIG. 11 is an illustration of a third system for manufacturing the
present invention using a tube 27 of extruded non-cured or
non-vulcanized silicon rubber. As tube 27 is extruded, regions 28
are pinched onto itself and are thus bound together. The regions of
tube 27 that are not pinched together form the fillable chambers
30A, 30B and 30C. Tube 27 is extruded, and then separated along
lines 29 into separate devices fillable chambers 30A, 30B and 30C,
etc. Note: line 29 may simply be a line passing through a region of
tube 27 that has been bound onto itself. As such, the ends of the
separate devices 10A, 10B, etc. can be sealed. Thereafter, the
distal ends 41 of fillable tubes 40 can be poked through side holes
in band 20 and inserted into the separate fillable chambers 30.
Thereafter, fillable tubes 40 can be adhesively bound into
position, for example with a non-vulcanized silicone rubber tab 45
being rolled around, pressed in place, and heated to bond tubing 40
in position such that the tubing remains in fluid communication
with fillable chambers 30.
FIG. 12 shows an alternate embodiment of the invention in which
device 100 comprises a plurality of pockets 102 into which fillable
chambers 104 are received. Each fillable chamber 104 has its own
dedicated filling tube 106. Device 100 operates in a manner similar
to device 10 as described above, with the only difference being
that each fillable chamber is not integrally formed into band 20 as
depicted in the previous embodiments, but the equivalent function
of chamber 30 is now accomplished by the combination of a pocket
102 into which a separate fillable chamber 104 is inserted. These
pockets into which fillable chambers 104 are received may simply be
formed by bonding or attaching layers 22 and 24 along the sides and
bottom edges of each pocket. Each fillable chamber is then bonded
into place or layers 22 and 24 are bonded together to entrap each
chamber in place.
Lastly, FIG. 13 shows a close-up view of the blunt needle port 44
that can be applied to the end of any of the tubing 40. (For
example, as illustrated as tubing 40A in FIG. B. The blunt needle
port 44 may be formed by injecting room temperature vulcanized
(RTV) silicone rubber approximately half-way into a short piece of
silicone rubber tubing. The RTV cures and then the first insertion
of a blunt needle tears a slit in the RTV section creating a
sealable slit and port. The section of tubing absent of RTV acts as
a pilot to help locate, hold, seal, and guide the insertion of a
blunt hypodermic needle. This blunt needle port 44 is then bonded
into tubing 40 using RTV silicone rubber.
Device Size
Although the size of the device depends on the purpose for which it
is being implanted, it is contemplated that the device will be wide
enough (measured from the top edge, i.e. the atrium edge, to the
outside of the second or bottom edge, i.e. the apex edge) to
provide efficient support to the atrio-ventricular grove.
Accordingly, in one embodiment, the device is between 2 and 5
centimeters wide. In other embodiments, the device may be adapted
to provide support over a larger area of the heart. This would
provide specifically for reinforcement of areas of scar or muscular
weakness as in dyskinetic infracted areas of the myocardium.
As shown in FIG. 1, the distance between the base and the bottom of
the apex of the heart can be expressed as distance "X". Because the
focus of the device of the present invention is base stabilization,
it is generally preferred that the width of the device be less than
or equal to 1/2X, and be adapted for placement around the top half
of the distance X, i.e. closer to the A-V Groove than the bottom of
the apex.
Device Attachment
The device may be attached to the outside of the base of the heart
by any known method. For example, attachment may be biological,
chemical or mechanical. Biological attachment may be brought about
by the interaction of the device with the surrounding tissues and
cells, and can be promoted by providing appropriate enhancers of
tissue growth. Alternatively, chemical attachment may be provided
by supplying a mechanism for chemical attachment of the device, or
portions thereof, to the external surface of the heart. In yet
another embodiment, the rigidity and tightness of the device around
the heart may provide for sufficient mechanical attachment due to
the forces of the heart against the device without the need for
other means of attachment.
In other alternate optional embodiments, the device instead further
comprises attachment members, such as tabs. Specific anchor points
or loops made of any biocompatible and implantable material may be
attached to the edges or to the center portion or both to
facilitate anchoring. Suitable materials include, inter alia,
polyester, polypropylene or complex polymers. Alternative
attachment members may comprise suture materials, protrusions that
serve as sites for suturing or stapling, as well as other
structural members that facilitate attachment to the surface of the
heart.
Implantation
The BACE.TM. system may be implanted through a conventional
midline-total sternotomy, sub maximal sternotomy or partial upper
or lower sternotomy. Alternatively, the device may be implanted
through a thoracotomy incision, or a Video Assisted Thoracoscopic
(VAT) approach using small incisions. The BACE.TM. system can also
be implanted by a subcostal incision as in the Sub-Costal
Hand-Assisted Cardiac Surgery (SHACS). Additionally, the BACE.TM.
system may be implanted with sutures onto epicardium or clips,
staples, or adhesive material that can secure the device on the
heart accurately. The device may also be implanted using robotic
placement of the device along the posterior aspects of the base of
the heart.
The method of implantation and the adequacy of the external
annuloplasty can be dynamically assessed by intra-operative
trans-esophageal echocardiography, epicardial echocardiography or
trans-thoracic echocardiography. The size of the device is assessed
based on external circumference measurements of the cardiac base in
the fully loaded beating heart state.
EXPERIMENTAL RESULTS
The device was tested with good results with 4 fluid chambers
around the mitral valve side of the heart. The fluid chambers were
filled one at a time with contrast media (fluid visible under
fluoroscopy), and were thus visible under fluoroscopy. Saline was
first extracted from the chambers that was present during
implantation from priming them. Next, about 4 cc of contrast media
was injected into each chamber and a fluoroscopy picture was taken.
The diameter across the mitral valve was measured before and after
filling the chambers. The measurement before was 3.73 cm and then
it reduced to 3.02 cm. This test shows that the mitral valve
annulus can be reduced in diameter using the present invention.
* * * * *
References