US20090132035A1 — Prosthetic Heart Valves, Support Structures and S…

Claim 1

Independent Claim 64 words

1 . A medical device, comprising: an expandable support structure comprising a plurality of panels and hinges located between the panels, the expandable support structure having an inner lumen, wherein each panel has at least one portion deflected in an outwardly radial fashion and wherein at least one of the hinges is formed at a junction between the deflected portions of two adjacent panels.

Claim 2

Dependent Claim 64 words

1 . A medical device, comprising: an expandable support structure comprising a plurality of panels and hinges located between the panels, the expandable support structure having an inner lumen, wherein each panel has at least one portion deflected in an outwardly radial fashion and wherein at least one of the hinges is formed at a junction between the deflected portions of two adjacent panels.

Claim 3

Dependent Claim 59 words

2 . The medical device of claim 1 , wherein each panel has an upper latitudinal edge and lower latitudinal edge, the edges forming the upper and lower peripheries of the support structure, and wherein each panel includes a pair of longitudinal edges, each longitudinal edge being generally perpendicular to the upper and lower latitudinal edges of each panel.

Claim 4

Dependent Claim 34 words

3 . The medical device of claim 2 , wherein the hinge has a length that is equal to the length of the longitudinal edge of the panel upon which the hinge is formed.

Claim 5

Dependent Claim 34 words

4 . The medical device of claim 2 , wherein the hinge has a length that is less than the length of the longitudinal edge of the panel upon which the hinge is formed.

Claim 6

Dependent Claim 14 words

5 . The medical device of claim 4 , wherein the hinge is tab-like.

Claim 7

Dependent Claim 31 words

6 . The medical device of claim 5 , wherein the tab-like hinge is a first tab-like hinge, the device further comprising a second tab-like hinge between the two adjacent panels.

Claim 8

Dependent Claim 33 words

7 . The medical device of claim 6 , wherein the portion of the longitudinal edges of each of the two adjacent panels located between the first and second tab-like hinges are unjoined.

Claim 9

Dependent Claim 24 words

8 . The medical device of claim 5 , wherein the tab-like hinge extends outwardly from the two adjacent panels in a non-perpendicular manner.

Claim 10

Dependent Claim 27 words

9 . The medical device of claim 4 , wherein one or more panels includes one or more slots formed in the panels adjacent to the hinge.

Claim 11

Dependent Claim 23 words

10 . The medical device of claim 9 , wherein the one or more slots are elongate slots oriented circumferentially in the panels.

Claim 12

Dependent Claim 22 words

11 . The medical device of claim 1 , further comprising an elastomeric element coupled with the deflected portions of the hinge.

Claim 13

Dependent Claim 25 words

12 . The medical device of claim 11 , wherein the elastomeric element is seated upon an indentation in a deflected portion of the hinge.

Claim 14

Dependent Claim 25 words

13 . The medical device of claim 12 , wherein the hinge is band-like and is circumferentially wrapped around the deflected portions of the hinge.

Claim 15

Dependent Claim 31 words

14 . The medical device of claim 1 , wherein a portion of the panel adjacent to the area where the deflected portions are joined to form the hinge curves radially.

Claim 16

Dependent Claim 19 words

15 . The medical device of claim 1 , wherein the junction between the deflected portions comprises a weld.

Claim 17

Dependent Claim 19 words

16 . The medical device of claim 1 , wherein the junction between the deflected portions comprises a rivet.

Claim 18

Dependent Claim 28 words

17 . The medical device of claim 1 , wherein each of the deflected portions includes a hole, the device further comprising a suture threaded through the holes.

Claim 19

Dependent Claim 29 words

18 . The medical device of claim 1 , wherein each of the deflected portions has complementary features configured to interlock with the features of the other deflected portion.

Claim 20

Dependent Claim 21 words

19 . The medical device of claim 1 , wherein the outer edge of the deflected portions comprise tissue engaging features.

Claim 21

Dependent Claim 20 words

20 . The medical device of claim 1 , further comprising a valvular body coupled with the expandable support structure.

Claim 22

Dependent Claim 38 words

21 . The medical device of claim 2 , wherein the length of the periphery of a first side of the support is less than the length of the periphery of a second side of the support structure.

Claim 23

Dependent Claim 26 words

22 . The medical device of claim 1 , wherein the support structure is foldable such that the support structure is contractable from an expanded state.

Claim 24

Dependent Claim 37 words

23 . The medical device of claim 1 , wherein the support structure is configured for placement within the aorta of a patient and further comprises a valvular body located within a lumen of the support structure.

Claim 25

Dependent Claim 79 words

24 . A medical device, comprising: an expandable support structure comprising a plurality of panels and hinges between the panels, the expandable support structure having a first end and a second end with an inner lumen therebetween, wherein each panel is curved in a convex fashion such that the diameter of the expandable support structure at either the first or second ends is less than the diameter of the expandable support structure at a central location between the ends.

Claim 26

Dependent Claim 79 words

24 . A medical device, comprising: an expandable support structure comprising a plurality of panels and hinges between the panels, the expandable support structure having a first end and a second end with an inner lumen therebetween, wherein each panel is curved in a convex fashion such that the diameter of the expandable support structure at either the first or second ends is less than the diameter of the expandable support structure at a central location between the ends.

Claim 27

Dependent Claim 30 words

25 . The medical device of claim 24 , wherein each panel has a radius of curvature, the radius of curvature of at least one of the panels being varying.

Claim 28

Dependent Claim 30 words

26 . The medical device of claim 24 , wherein each panel has a radius of curvature, the radius of curvature of at least one of the panels being constant.

Claim 29

Dependent Claim 80 words

27 . A medical device, comprising: an expandable support structure comprising a plurality of panels with hinges between the panels, the expandable support structure having a first end and a second end with an inner lumen therebetween, wherein each panel is curved in a concave fashion such that the diameter of the expandable support structure at a central location between the ends is less than the diameter of the expandable support structure at either the first end or second end.

Claim 30

Dependent Claim 80 words

27 . A medical device, comprising: an expandable support structure comprising a plurality of panels with hinges between the panels, the expandable support structure having a first end and a second end with an inner lumen therebetween, wherein each panel is curved in a concave fashion such that the diameter of the expandable support structure at a central location between the ends is less than the diameter of the expandable support structure at either the first end or second end.

Claim 31

Dependent Claim 17 words

28 . The medical device of claim 27 , wherein is the expandable support structure is hourglass-shaped.

Claim 32

Dependent Claim 35 words

29 . The medical device of claim 27 , wherein the diameter of the first end of the expandable support structure is equal to the diameter of the second end of the expandable support structure.

Claim 33

Dependent Claim 35 words

30 . The medical device of claim 27 , wherein the diameter of the first end of the expandable support structure is less than the diameter of the second end of the expandable support structure.

Claim 34

Dependent Claim 71 words

31 . A medical device, comprising: an expandable support structure comprising a plurality of panels with hinges between the panels, the expandable support structure having an inner lumen, wherein each panel surface includes at least one longitudinal depression, wherein the inner surface of the longitudinal depressions are relatively more adjacent to each other in the center of the expandable support structure when said expandable support structure is in a collapsed state.

Claim 35

Dependent Claim 71 words

31 . A medical device, comprising: an expandable support structure comprising a plurality of panels with hinges between the panels, the expandable support structure having an inner lumen, wherein each panel surface includes at least one longitudinal depression, wherein the inner surface of the longitudinal depressions are relatively more adjacent to each other in the center of the expandable support structure when said expandable support structure is in a collapsed state.

Claim 36

Dependent Claim 38 words

32 . A medical device of claim 31 , wherein the depression has a length substantially equal to the longitudinal length of the panel and being generally perpendicular to the upper and lower latitudinal edges of each panel.

Claim 37

Dependent Claim 62 words

33 . A medical device, comprising: an expandable support structure comprising a plurality of panels, wherein each panel includes a plurality of apertures, the density of the apertures in each panel forming a gradient where the density of apertures proximal to the lower periphery of the panel is greater than the density of apertures proximal to the upper periphery of the panel.

Claim 38

Dependent Claim 62 words

33 . A medical device, comprising: an expandable support structure comprising a plurality of panels, wherein each panel includes a plurality of apertures, the density of the apertures in each panel forming a gradient where the density of apertures proximal to the lower periphery of the panel is greater than the density of apertures proximal to the upper periphery of the panel.

Claim 39

Dependent Claim 38 words

34 . A medical device, comprising: an expandable support structure comprising a plurality of panels and hinges between the panels, wherein each panel surface includes one or more ridges, each ridge facing in an outwardly or inwardly direction.

Claim 40

Dependent Claim 38 words

34 . A medical device, comprising: an expandable support structure comprising a plurality of panels and hinges between the panels, wherein each panel surface includes one or more ridges, each ridge facing in an outwardly or inwardly direction.

Claim 41

Dependent Claim 34 words

35 . A medical device of claim 34 , wherein the ridges are disposed such that inwardly facing ridges nest with outwardly facing ridges when the expandable support structure is in a contracted state.

Claim 42

Dependent Claim 82 words

36 . A method of attaching a valve leaflet to an implantable support structure, comprising: placing a valve leaflet between two plates, wherein the surfaces of the plates have a plurality of apertures arranged in pre-determined locations; threading a plurality of wires through the pre-determined apertures of the plates; tensioning the wires to transition the valve leaflet from a first state to a second state; and attaching the valve leaflet to a curved portion of the support structure while tensioning the wires.

Claim 43

Dependent Claim 82 words

36 . A method of attaching a valve leaflet to an implantable support structure, comprising: placing a valve leaflet between two plates, wherein the surfaces of the plates have a plurality of apertures arranged in pre-determined locations; threading a plurality of wires through the pre-determined apertures of the plates; tensioning the wires to transition the valve leaflet from a first state to a second state; and attaching the valve leaflet to a curved portion of the support structure while tensioning the wires.

Claim 44

Dependent Claim 33 words

37 . The method of claim 36 , further comprising cutting the valve leaflet from a sheet of compliant material into a pre-determined shape prior to placing the valve leaflet between the plates.

Claim 45

Dependent Claim 34 words

38 . The method of claim 36 , further comprising removing the wires from the valve leaflet and support structure after the valve leaflet is attached to the curved portion of the support structure.

Claim 46

Dependent Claim 34 words

39 . The method of claim 36 , further comprising removing the wires from the valve leaflet and support structure as the valve leaflet is sewn to the curved portion of the support structure.

Claim 47

Dependent Claim 69 words

40 . A method of transitioning an expandable support structure between states, comprising: accessing a plurality of tethers threaded through an expandable support structure, wherein each tether is threaded through at least one aperture in a different panel of the support structure and an aperture in a stop structure of a delivery device; tensioning the tethers to transition the support structure from an expanded state to a collapsed state.

Claim 48

Dependent Claim 69 words

40 . A method of transitioning an expandable support structure between states, comprising: accessing a plurality of tethers threaded through an expandable support structure, wherein each tether is threaded through at least one aperture in a different panel of the support structure and an aperture in a stop structure of a delivery device; tensioning the tethers to transition the support structure from an expanded state to a collapsed state.

Claim 49

Dependent Claim 21 words

41 . The method of claim 40 , wherein each tether is coupled to a retractable structure of the delivery device.

Claim 50

Dependent Claim 39 words

42 . The method of claim 41 further comprising: withdrawing the retractable structure of the delivery device such that the tethers are released and the support structure is free to transition from a collapsed state to an expanded state.

Claim 51

Dependent Claim 21 words

43 . The method of claim 40 , wherein each tether is threaded through a second aperture in the respective panel.

Claim 52

Dependent Claim 46 words

44 . The method of claim 40 , further comprising: positioning a plurality of wrap pins over the collapsed end of the support structure and advancing the wrap pins toward a second edge of each panel in the support structure to collapse the entire support structure.

Claim 53

Dependent Claim 22 words

45 . The method of claim 40 , further comprising attaching each tether to a pulley-type element attached to the delivery device.

Claim 54

Dependent Claim 54 words

46 . A method of transitioning an expandable support structure between states, comprising: accessing a plurality of tethers threaded through panels of an expandable support structure, wherein each tether is threaded through two apertures each in different panels of the support structure; and tensioning the tethers to at least partially collapse the support structure.

Claim 55

Dependent Claim 54 words

46 . A method of transitioning an expandable support structure between states, comprising: accessing a plurality of tethers threaded through panels of an expandable support structure, wherein each tether is threaded through two apertures each in different panels of the support structure; and tensioning the tethers to at least partially collapse the support structure.

Claim 56

Dependent Claim 44 words

47 . The method of claim 46 further comprising: positioning a plurality of wrap pins over the collapsed end of the support structure and advancing the wrap pins toward a second end of the support structure so as to collapse the entire support structure.

Claim 57

Dependent Claim 17 words

48 . The method of claim 46 , further comprising tensioning the tethers with a pulley-type element.

Claim 58

Dependent Claim 73 words

49 . The method of claim 46 , wherein a first tether is routed through a first aperture in a first panel and a second aperture in a second panel, a second tether is routed through a third aperture in the second panel and a fourth aperture in a third panel, and a third tether is routed through a fifth aperture in the third panel and a sixth aperture in the first panel.

Claim 59

Dependent Claim 93 words

50 . A medical device, comprising: an expandable support structure comprising a plurality of panels and hinges located between the panels, wherein one or more removable needles, each having a proximal end and a distal end, and each having a length greater than the longitudinal length of the support structure, intersect the panel surface through one or more apertures in the panel surface, and wherein a distal portion of a tether is coupled to the proximal end of each needle and a proximal portion of a tether is coupled to a delivery device.

Claim 60

Dependent Claim 93 words

50 . A medical device, comprising: an expandable support structure comprising a plurality of panels and hinges located between the panels, wherein one or more removable needles, each having a proximal end and a distal end, and each having a length greater than the longitudinal length of the support structure, intersect the panel surface through one or more apertures in the panel surface, and wherein a distal portion of a tether is coupled to the proximal end of each needle and a proximal portion of a tether is coupled to a delivery device.

Claim 61

Dependent Claim 57 words

51 . The medical device of claim 50 , further comprising a compliant frame having a locked state and an unlocked state, wherein the expandable support structure is locked to the compliant frame in the locked state, and wherein the support structure is removable from the compliant frame when the compliant frame is in the unlocked state.

Prosthetic Heart Valves, Support Structures and Systems and Methods for Implanting the Same

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