US20060025856A1 — Annuloplasty band and method

Claim 1

Independent Claim 66 words

1 . An annuloplasty band for repair of an atrio-ventricular valve forming a valve annulus, the band comprising: a sheath; a generally arcuate stiffening element disposed within the sheath, the stiffening element extending from a first end to a second end, wherein each of the first and second ends includes an eyelet adapted to receive a suture for securing the annuloplasty band to the valve annulus.

Claim 2

Dependent Claim 66 words

1 . An annuloplasty band for repair of an atrio-ventricular valve forming a valve annulus, the band comprising: a sheath; a generally arcuate stiffening element disposed within the sheath, the stiffening element extending from a first end to a second end, wherein each of the first and second ends includes an eyelet adapted to receive a suture for securing the annuloplasty band to the valve annulus.

Claim 3

Dependent Claim 50 words

2 . The annuloplasty band of claim 1 , wherein the valve is a mitral valve having an antero-lateral trigone, a posterior leaflet, and a postero-medial trigone, and further wherein the eyelets are adapted to secure the annuloplasty band to the intero-lateral trigone and the postero-medial trigone, respectively, via sutures.

Claim 4

Dependent Claim 69 words

3 . The annuloplasty band of claim 1 , wherein the valve is a tricuspid valve having an anterior leaflet, a posterior leaflet and a septal leaflet, each of the leaflets defined by a base relative to the valve annulus, and further wherein the eyelets are adapted to secure the annuloplasty band to the base of the septal leaflet and the based of the anterior leaflet, respectively, via sutures.

Claim 5

Dependent Claim 27 words

4 . The annuloplasty band of claim 1 , wherein the stiffening element includes a wire having opposite ends bent back onto itself to form the eyelets.

Claim 6

Dependent Claim 18 words

5 . The annuloplasty band of claim 4 , wherein the wire is overmolded with an elastomeric material.

Claim 7

Dependent Claim 28 words

6 . The annuloplasty band of claim 5 , wherein the elastomeric material includes a material selected from the group consisting of biocompatible thermal plastic elastomer and silicone.

Claim 8

Dependent Claim 54 words

7 . The annuloplasty band of claim 4 , wherein the wire is configured to define a compound curve including an intermediate portion having a first radius of curvature and opposite end portions each having a second radius of curvature, wherein the first radius of curvature is greater than the second radius of curvature.

Claim 9

Dependent Claim 65 words

8 . The annuloplasty band of claim 7 , wherein each of the end portions includes: a transition segment extending outwardly from the intermediate portion, the transition segment having the second radius of curvature; an end segment extending from the transition segment, the end segment having a third radius of curvature; wherein the second radius of curvature is greater than the third radius of curvature.

Claim 10

Dependent Claim 18 words

9 . The annuloplasty band of claim 1 , wherein the stiffening element includes a molded polymeric element.

Claim 11

Dependent Claim 18 words

10 . The annuloplasty band of claim 1 , wherein the sheath is marked to indicate eyelet position.

Claim 12

Dependent Claim 31 words

11 . The annuloplasty band of claim 10 , wherein the sheath is marked to indicate eyelet placement by a suture having a color different from a color of the sheath.

Claim 13

Dependent Claim 15 words

12 . The annuloplasty band of claim 1 , wherein the stiffening element is radio-opaque.

Claim 14

Dependent Claim 18 words

13 . The annuloplasty band of claim 1 , wherein the sheath is formed of a fabric material.

Claim 15

Dependent Claim 17 words

14 . The annuloplasty band of claim 1 , wherein the sheath is formed of biological tissue.

Claim 16

Dependent Claim 21 words

15 . The annuloplasty band of claim 1 , wherein the band has a thickness no greater than approximately 3 mm.

Claim 17

Dependent Claim 26 words

16 . The annuloplasty band of claim 1 , wherein the stiffening element is generally arcuate in an X-Y plane and generally saddle-shaped in a Z-plane.

Claim 18

Dependent Claim 79 words

17 . A method of implanting an annuloplasty band for repairing an atrio-ventricular valve defining a valve annulus, the method comprising: providing an annuloplasty band including a sheath and a generally arcuate stiffening element disposed within the sheath, the stiffening element extending from a first end to a second end, each end forming an eyelet adapted to receive a suture; positioning the annuloplasty band along the valve annulus; and suturing the respective eyelets to tissue of the valve annulus.

Claim 19

Dependent Claim 79 words

17 . A method of implanting an annuloplasty band for repairing an atrio-ventricular valve defining a valve annulus, the method comprising: providing an annuloplasty band including a sheath and a generally arcuate stiffening element disposed within the sheath, the stiffening element extending from a first end to a second end, each end forming an eyelet adapted to receive a suture; positioning the annuloplasty band along the valve annulus; and suturing the respective eyelets to tissue of the valve annulus.

Claim 20

Dependent Claim 54 words

18 . The method of claim 17 , wherein the atrio-ventricular valve is a mitral valve defining an antero-lateral trigone and a postero-medial trigone, and further wherein suturing the eyelets includes suturing the eyelet of the first end to the antero-lateral trigone and suturing the eyelet of the second end to the postero-medial trigone.

Claim 21

Dependent Claim 80 words

19 . The method of claim 17 , wherein the atrio-ventricular valve is a tricuspid valve defining an anterior leaflet and a septal leaflet, each of the leaflets forming a base relative to the valve annulus, and further wherein suturing the eyelets includes suturing the eyelet of the first end to the base of the anterior leaflet adjacent the valve annulus and suturing the eyelet of the second end to the base of the septal leaflet adjacent the valve annulus.

Claim 22

Dependent Claim 38 words

20 . The method of claim 17 , wherein providing an annuloplasty band includes forming markings on the sheath indicative of locations of the eyelets, and further wherein suturing the eyelets include passing sutures through the respective markings.

Claim 23

Dependent Claim 134 words

21 . A combination annuloplasty band and holder for use by a surgeon in conjunction with annuloplasty surgery performed on a patient's heart valve defining a valve annulus, comprising: an annuloplasty band comprising a sheath and a generally arcuate stiffening element disposed within the sheath, the stiffening element extending from a first end to a second end, wherein each of the first and second ends forms an eyelet adapted to receive a suture for securing the annuloplasty band to the valve annulus; and a holder selectively maintaining the annuloplasty band, the holder including a band-retaining plate forming a perimeter defining a curvature corresponding generally with a curvature of the annuloplasty band, the perimeter further forming cut-out areas adapted to provide clearance about the eyelets upon mounting of the annuloplasty band to the band-retaining plate.

Claim 24

Dependent Claim 134 words

21 . A combination annuloplasty band and holder for use by a surgeon in conjunction with annuloplasty surgery performed on a patient's heart valve defining a valve annulus, comprising: an annuloplasty band comprising a sheath and a generally arcuate stiffening element disposed within the sheath, the stiffening element extending from a first end to a second end, wherein each of the first and second ends forms an eyelet adapted to receive a suture for securing the annuloplasty band to the valve annulus; and a holder selectively maintaining the annuloplasty band, the holder including a band-retaining plate forming a perimeter defining a curvature corresponding generally with a curvature of the annuloplasty band, the perimeter further forming cut-out areas adapted to provide clearance about the eyelets upon mounting of the annuloplasty band to the band-retaining plate.

Claim 25

Dependent Claim 35 words

22 . The combination of claim 21 , wherein: the stiffening element comprises a wire having opposite ends bent back onto itself to form the eyelets; and the wire is overmolded with an elastomeric material.

Claim 26

Dependent Claim 17 words

23 . The combination of claim 21 , wherein the sheath is marked to indicate eyelet placement.

Claim 27

Dependent Claim 30 words

24 . The combination of claim 23 , wherein the sheath is marked to indicate eyelet placement by a suture having a color contrasting with a color of the sheath.

Claim 28

Dependent Claim 23 words

25 . The combination of claim 21 , wherein the annuloplasty band and the band-retaining plate are adapted for repairing a mitral valve.

Claim 29

Dependent Claim 23 words

26 . The combination of claim 21 , wherein the annuloplasty band and the band-retaining plate are adapted for repairing a tricuspid valve.

Claim 30

Dependent Claim 90 words

27 . A holder for an annuloplasty band including a band-retaining plate forming a perimeter defining: an arcuate segment; opposing cut-out regions extending from opposite sides of the arcuate segment, respectively; and a trailing segment extending between the opposing cut-out regions opposite the arcuate segment; wherein the opposing cut-out regions each define a transition from the arcuate segment to the trailing segment, the cut-out regions each having a first portion extending inwardly from the arcuate segment and a second portion extending outwardly from the first portion to the trailing segment.

Claim 31

Dependent Claim 90 words

27 . A holder for an annuloplasty band including a band-retaining plate forming a perimeter defining: an arcuate segment; opposing cut-out regions extending from opposite sides of the arcuate segment, respectively; and a trailing segment extending between the opposing cut-out regions opposite the arcuate segment; wherein the opposing cut-out regions each define a transition from the arcuate segment to the trailing segment, the cut-out regions each having a first portion extending inwardly from the arcuate segment and a second portion extending outwardly from the first portion to the trailing segment.

Claim 32

Dependent Claim 51 words

28 . The holder of claim 27 , wherein the arcuate segment defines an arc length corresponding generally with an arc length of an annuloplasty band, and wherein the cut-out regions are each adapted to provide access to an eyelet portion of the annuloplasty band when mounted to the band-retaining plate.

Claim 33

Dependent Claim 19 words

29 . The holder of claim 27 , wherein the trailing segment tapers inwardly between the opposing cut-out regions.

Claim 34

Dependent Claim 48 words

30 . An annuloplasty band for repair of an atrio-ventricular valve of a patient's heart, the band comprising: a sheath; and a generally arcuate stiffening element disposed within the sheath, the stiffening element having rounded ends; wherein the band has a thickness no greater than about 3 mm.

Claim 35

Dependent Claim 48 words

30 . An annuloplasty band for repair of an atrio-ventricular valve of a patient's heart, the band comprising: a sheath; and a generally arcuate stiffening element disposed within the sheath, the stiffening element having rounded ends; wherein the band has a thickness no greater than about 3 mm.

Claim 36

Dependent Claim 21 words

31 . The annuloplasty band of claim 30 , wherein the band has a thickness no greater than about 2.7 mm.

Claim 37

Dependent Claim 21 words

32 . The annuloplasty band of claim 30 , wherein the band has a thickness no greater than about 2.5 mm.

Claim 38

Dependent Claim 18 words

33 . The annuloplasty band of claim 30 , wherein stiffening element forms eyelets at the ends thereof.

Claim 39

Dependent Claim 99 words

34 . A sizer device for use in evaluating a size of an atrio-ventricular valve annulus as part of a valve repair procedure, the sizer device including a sizer forming a perimeter defining: a leading segment shaped in accordance with a portion of a shape of a natural atrio-ventricular valve annulus; a trailing segment opposite the leading segment, and opposing cut-out segments located at opposite sides of the leading segment, respectively, wherein the opposing cut-out segments are adapted to facilitate viewing of portions of the valve annulus upon placement of the sizer into close proximity to the valve annulus.

Claim 40

Dependent Claim 99 words

34 . A sizer device for use in evaluating a size of an atrio-ventricular valve annulus as part of a valve repair procedure, the sizer device including a sizer forming a perimeter defining: a leading segment shaped in accordance with a portion of a shape of a natural atrio-ventricular valve annulus; a trailing segment opposite the leading segment, and opposing cut-out segments located at opposite sides of the leading segment, respectively, wherein the opposing cut-out segments are adapted to facilitate viewing of portions of the valve annulus upon placement of the sizer into close proximity to the valve annulus.

Claim 41

Dependent Claim 47 words

35 . The sizer device of claim 34 , wherein the leading segment is shaped in accordance with a posterior portion of a mitral valve, and further wherein the opposing cut-out segments are adapted to facilitate viewing of the antero lateral trigone and the postero-medial trigone, respectively.

Claim 42

Dependent Claim 25 words

36 . The sizer device of claim 34 , wherein the sizer further includes indicia adapted to highlight a location of the opposing cut-out segments.

Annuloplasty band and method

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