VENTRICULARLY-ANCHORED PROSTHETIC VALVES

• US 20150351906A1
• Filed: 01/23/2014
• Published: 12/10/2015
• Est. Priority Date: 01/24/2013
• Status: Abandoned Application

• Current Assignee: Cardiovalve Ltd.
• Original Assignee: Mitraltech Ltd.
• Inventors: HAMMER, Tal, ZIPORY, Yuval, HERMAN, Yaron, MILLER, Eran, NEEMAN, Rotem, KRUGLOVA, Natalia, REICH, Tal, HACOHEN, Gil
• Application Number:
  US14/763,004
• Publication Number:
  US 20150351906A1
• Time in Patent Office: Days
• US Class Current: 1/1
• CPC Class Codes: A61F 2/2409 Support rings therefor, e.g. for connecting valves to tissue annuloplasty rings A61F2/2442
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2427 Devices for manipulating or deploying heart valves during implantation
• CPC Class Codes: A61F 2/2436 Deployment by retracting a sheath
• CPC Class Codes: A61F 2210/0076 multilayered, e.g. laminated structures
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2220/0025 Connections or couplings between prosthetic parts, e.g. between modular parts; Connecting elements
• CPC Class Codes: A61F 2220/0075 sutured, ligatured or stitched, retained or tied with a rope, string, thread, wire or cable
• CPC Class Codes: A61F 2250/0098 radio-opaque, e.g. radio-opaque markers

Abstract

Apparatus is provided, including: (A) a valve body (204) including a first frame (206) shaped to define a lumen therethrough, and a valve member (205) disposed within the lumen, (B) an upstream support (210), configured to be placed against an upstream surface of a native heart valve, and (C) a flexible sheet (214) that couples the upstream support to the valve body. The valve body has a compressed state in which the first frame has a first diameter, and an expanded state in which the first frame has a second diameter that is greater than the first diameter. The support includes a second frame (212) that has a compressed state, and an expanded state in which the second frame is annular, has an inner perimeter that defines an opening through the second frame, and has an outer perimeter. Other embodiments are also described.

Claims

1. Apparatus for use with a native valve of a heart of a subject, the apparatus comprising:

a valve body;

comprising (1) a first frame shaped to define a lumen therethrough, and (2) a valve member disposed within the lumen,

having a compressed state in which the first frame has a first diameter, and

having an expanded state in which the first frame has a second diameter that is greater than the first diameter;

an upstream support;

configured to be placed against an upstream surface of the native valve,

comprising a second frame,

having a compressed state, and

having an expanded state in which the second frame is annular, has an inner perimeter that defines an opening through the second frame, and has an outer perimeter; and

a flexible sheet that couples the upstream support to the valve body.

2. The apparatus according to claim 1, wherein the upstream support is coupled to the valve body only via the sheet.

3. The apparatus according to claim 1, wherein:

the valve body has an upstream end, a downstream end, and a longitudinal axis therebetween along which the lumen is defined, and

when the valve body is in the expanded state thereof and the upstream support is in the expanded state thereof;

the first frame is attached to the second frame at the inner perimeter of the second frame, and

the sheet is attached to the valve body and to the upstream support in a manner that defines a pocket region between the sheet and at least the inner perimeter of the second frame, the sheet not being attached to the first frame or the second frame in the pocket region.

4. The apparatus according to claim 1, wherein the sheet provides fluid communication between the opening and the lumen.

5. The apparatus according to claim 1, wherein the sheet is not attached to the inner perimeter of the second frame.

6. The apparatus according to claim 1, wherein the sheet is not attached to an upstream end of the valve body.

7. The apparatus according to claim 1, wherein the sheet is generally annular when the valve body is in the expanded state thereof and the upstream support is in the expanded state thereof.

8. The apparatus according to claim 1, wherein the sheet is generally frustoconical when the valve body is in the expanded state thereof and the upstream support is in the expanded state thereof.

9. The apparatus according to claim 1, wherein the sheet is attached to the inner perimeter of the second frame.

10. The apparatus according to claim 1, wherein the sheet is circumferentially attached to the second frame at a radius that is greater than a radius of the inner perimeter.

11. The apparatus according to claim 1, wherein the sheet is circumferentially attached to the second frame at the outer perimeter of the second frame.

12. The apparatus according to claim 1, wherein the sheet is attached to an upstream end of the valve body.

13. The apparatus according to claim 1, wherein the first frame is generally cylindrical in both the compressed state thereof and the expanded state thereof.

14. The apparatus according to claim 1, wherein the second frame is generally cylindrical in the compressed state thereof.

15. The apparatus according to any one of claims 1-14, wherein the valve body comprises at least one downstream anchor, configured such that, in the expanded configuration of the valve body, the anchor protrudes radially outward from the first frame.

16. The apparatus according to claim 15, further comprising at least one tensioning element, coupled to the valve body and to the upstream support, a length of the tensioning element between the valve body and the upstream portion being adjustable such that a distance between the first frame and the second frame is adjustable.

17. The apparatus according to claim 16, wherein the at least one tensioning element comprises a tether.

18. The apparatus according to claim 16, wherein the at least one tensioning element is coupled to the first frame, and slidably coupled to the second frame.

19. The apparatus according to any one of claims 1-14, wherein the valve body, the upstream support and the sheet together define a prosthetic valve assembly, the prosthetic valve assembly:

having an expanded state in which the valve body is in the expanded state thereof and the second frame of the upstream support is in the expanded state thereof,

having a compressed state in which;

the prosthetic valve assembly has a longitudinal axis,

the valve body is in the compressed state thereof at a first zone of the longitudinal axis,

the upstream support is in the compressed state thereof at a second zone of the longitudinal axis, and

the prosthetic valve assembly defines an articulation zone, between the first zone and the second zone, in which at least part of the sheet is disposed, in which neither the first frame nor the second frame is disposed, and about which the valve body and the upstream support are articulatable with respect to each other.

20. The apparatus according to claim 19, further comprising a delivery tool:

comprising a first housing configured to house and maintain at least part of the upstream support in the compressed state thereof, and defining a first housing orifice through which the at least part of the upstream support is removable from the first housing,

comprising a second housing configured to house and maintain at least part of the valve body in the compressed state thereof, and defining a second housing orifice through which the at least part of the valve body is removable from the second housing,

having a contracted state in which the second housing is disposed at a first distance from the first housing, and in which the delivery tool is configured to transluminally advance the prosthetic valve assembly in the compressed state thereof, to the native valve, and

having an extended state in which the second housing is disposed at a second distance from the first housing, the second distance being greater than the first distance, wherein the apparatus is configured such that, when the at least part of the upstream support is housed by the first housing and the at least part of the valve body is housed by the second housing, transitioning of the delivery tool from the contracted state into the extended state exposes at least part of at least one component selected from the group consisting of;

the valve body and the upstream support, from the housing that houses the selected component.

21. The apparatus according to claim 20, wherein:

the apparatus is configured to be used with at least two guide members,

the prosthetic valve assembly comprises at least two eyelets, each eyelet being slidable over a respective one of the guide members, and

the apparatus is configured such that the eyelets of the prosthetic valve assembly protrude radially outward and radially beyond an outer surface of the second housing while;

(1) the at least part of the valve body, in the compressed state thereof, is housed by the second housing, and (2) the at least part of the upstream support, in the compressed state thereof, is housed by the first housing.

22. The apparatus according to claim 21, wherein the eyelets are pivotably coupled to the valve body.

23. The apparatus according to claim 21, wherein the delivery tool further comprises at least two reference-force tubes, each reference-force tube configured (1) to be slidable over a respective one of the guide members, and (2) to apply a distally-directed force to the prosthetic valve assembly.

24. The apparatus according to claim 23, wherein, in the compressed state of the prosthetic valve assembly, each reference-force tube extends distally (1) through a lumen defined by the second frame of the upstream support, (2) through the sheet, and (3) along an outside of at least part of the valve body.

25. The apparatus according to claim 21, further comprising at least two locking members, each locking member:

having an unlocked state in which the locking member is slidable along a respective one of the guide members,

being transitionable into a locked state in which (1) the locking member is locked to the respective one of the guide members, and (2) the sliding of the eyelet over the guide member is inhibited.

26. The apparatus according to claim 25, further comprising the at least two guide members, wherein:

each guide member comprises;

a tubular member, shaped to define a lumen therethrough,

a tether, coupled at a distal end thereof to a tissue anchor configured to be anchored to ventricular tissue of the heart, at least a proximal portion of the tether being disposed within the lumen of the tubular member, and

a pull-wire, coupled at a distal portion thereof to the proximal portion of the tether, at least the distal portion of the pull-wire being disposed within the lumen of the tubular member,

the tubular member inhibits decoupling of the pull-wire from the tether while the distal portion of the pull-wire and the proximal portion of the tether are disposed within the lumen of the tubular member, and

while the tubular member of each guide member is disposed within the respective locking member, the tubular member inhibits transitioning of the locking member into the locked state.

27. The apparatus according to claim 26, wherein the apparatus is configured such that, for each respective guide member and locking member, while (1) the tubular member is disposed within the locking member, (2) the distal portion of the pull-wire and the proximal portion of the tether are disposed within the lumen of the tubular member, and (3) the tissue anchor is coupled to the ventricular tissue:

proximal sliding of the tubular member with respect to the tether facilitates automatic transitioning of the locking member into the locked state, and

further proximal sliding of the tubular member with respect to the tether facilitates decoupling of the pull-wire from the tether.

28. The apparatus according to claim 21, wherein at least one housing selected from the group consisting of:

the first housing and the second housing has a lateral wall that is shaped to define at least two slits, the eyelets being configured to protrude radially outward from the delivery tool via the slits.

29. The apparatus according to claim 28, wherein each slit of the at least one selected housing is continuous with the orifice of the at least one selected housing.

30. The apparatus according to claim 21, wherein the eyelets are coupled to and protrude radially outward from the valve body.

31. The apparatus according to claim 30, wherein the eyelets are pivotably coupled to the valve body.

32. The apparatus according to claim 20, wherein:

the articulation zone defined by the prosthetic valve assembly comprises a first articulation zone, and

while (1) the at least part of the valve body, in the compressed state thereof, is housed by the second housing, (2) the at least part of the upstream support, in the compressed state thereof, is housed by the first housing, and (3) the delivery tool is in the contracted state thereof, the apparatus defines a second articulation zone at a longitudinal zone of the apparatus (a) between the second housing and the first housing, and (b) in which is disposed at least part of the first articulation zone.

33. The apparatus according to claim 32, wherein the delivery tool further comprises a housing-control rod that extends through the first housing and is coupled to the second housing such that a first portion of the housing-control rod is disposed within the first housing, a second portion of the housing-control rod is disposed within the second housing, and a third portion of the housing-control rod (1) is disposed within the second articulation zone, and (2) is more flexible than at least one portion of the housing-control rod selected from the group consisting of:

the first portion and the second portion.

34. The apparatus according to claim 32, wherein:

the delivery tool further comprises (1) a control rod assembly comprising at least a first housing-control rod coupled to the first housing, and (2) a second housing-control rod, more flexible than the first housing-control rod, extending through the first housing-control rod, extending through the second articulation zone, and coupled to the second housing.

35. The apparatus according to claim 20, wherein the second housing orifice faces the first housing orifice.

36. The apparatus according to claim 20, wherein:

the delivery tool further comprises a flexible control rod assembly comprising (1) a first housing-control rod coupled to the first housing, (2) a second housing-control rod coupled to the second housing, and (3) a prosthesis-control rod reversibly couplable to the prosthetic valve assembly,

longitudinal movement of the second housing-control rod with respect to the first housing-control rod transitions the delivery tool between the contracted state and the extended state thereof, and

the valve body is removable from the second housing by moving the second housing-control rod with respect to the prosthesis-control rod.

37. The apparatus according to claim 36, wherein the prosthesis-control rod is reversibly couplable to the prosthetic valve assembly by being reversibly couplable to the valve body.

38. The apparatus according to claim 36, wherein at least part of the second housing-control rod is disposed within and slidable through the prosthesis-control rod, and at least part of the prosthesis-control rod is disposed within and slidable through the first housing-control rod.

39. The apparatus according to any one of claims 1-14, wherein the outer perimeter of the second frame has a third diameter that is greater than the second diameter.

40. The apparatus according to claim 39, wherein the inner perimeter has a fourth diameter that is greater than the second diameter.

41. The apparatus according to any one of claims 1-14, wherein, when the valve body is in the expanded state thereof and the upstream support is in the expanded state thereof, a gap is defined between the first frame and the second frame, the sheet spanning the gap.

42. The apparatus according to claim 41, wherein no metallic structure is disposed within the gap.

43. The apparatus according to any one of claims 1-14, wherein the sheet is configured to inhibit expansion of the second frame.

44. The apparatus according to claim 43, wherein the apparatus is configured such that when the second frame expands from the compressed state thereof toward the expanded state thereof, the sheet retains the second frame in a generally frustoconical shape by inhibiting expansion of at least the outer perimeter of the second frame.

45. The apparatus according to any one of claims 1-14, wherein the sheet extends over at least part of the second frame to serve as a covering of the upstream support.

46. The apparatus according to claim 45, wherein the covering defines a tissue-contacting surface of the upstream support.

47. The apparatus according to any one of claims 1-14, wherein the sheet extends over at least part of the first frame to serve as a covering of the valve body.

48. The apparatus according to claim 47, wherein the covering is disposed on an inner surface of the first frame.

49. Apparatus for use with a native valve of a heart of a subject, the apparatus comprising:

a prosthetic valve, configured to be percutaneously delivered to the native valve;

an annular upstream support, configured to be placed against an upstream surface of the native valve, and to support the prosthetic valve at the native valve;

a tissue anchor, comprising a tissue-engaging element configured to be anchored to ventricular muscle tissue of the heart;

a tether, coupled to the tissue anchor; and

a spring, couplable to the tether so as to elastically couple the tissue-engaging element to the prosthetic valve.

50. The apparatus according to claim 49, wherein the spring is shaped to define a repeating pattern.

51. The apparatus according to claim 49, wherein the spring is pre-loaded.

52. The apparatus according to claim 49, wherein the spring is a constant-force spring.

53. The apparatus according to any one of claims 49-52, wherein the spring is configured to facilitate extracorporeal fluoroscopic observation of a state of the spring.

54. The apparatus according to claim 53, wherein the spring is coupled to a plurality of radiopaque markers such that a juxtaposition of the markers changes as the state of the spring changes, the juxtaposition of the markers being extracorporeally fluoroscopically observable.

55. The apparatus according to claim 53, wherein the spring is coupled to at least one radiopaque marker, and the apparatus further comprises an intracorporeal reference, a juxtaposition between the radiopaque marker and the intracorporeal reference being extracorporeally fluoroscopically observable.

56. The apparatus according to claim 55, wherein the intracorporeal reference comprises a scale comprising a plurality of radiopaque markers.

57. The apparatus according to claim 56, wherein the plurality of radiopaque markers comprises a first plurality of radiopaque markers, and the at least one radiopaque marker comprises a second plurality of radiopaque markers.

58. The apparatus according to claim 53, wherein the spring is configured to provide distinct indication that is observable using fluoroscopy, when the spring is experiencing a force that is within a margin force from a target force.

59. The apparatus according to claim 58, wherein the spring is configured to provide the distinct indication when the spring experiences a force that is above 300 g force.

60. The apparatus according to claim 59, wherein the spring is configured to provide the distinct indication when the spring experiences a force that is above 400 g force.

61. The apparatus according to claim 60, wherein the spring is configured to provide the distinct indication when the spring experiences a force that is about 500 g force.

62. The apparatus according to any one of claims 49-52, wherein the spring is coupled to the prosthetic valve, and is intracorporeally lockable to the tether subsequently to anchoring of the tissue anchor to the ventricular muscle tissue.

63. The apparatus according to claim 62, wherein the spring is slidable along at least part of the tether, and is intracorporeally couplable to the tether by inhibiting the sliding.

64. The apparatus according to claim 62, wherein the prosthetic valve comprises a generally cylindrical valve body having an upstream end, and the spring comprises an elastically-deformable appendage that protrudes laterally from the valve body.

65. The apparatus according to claim 62, wherein:

the prosthetic valve comprises a generally cylindrical valve body having an upstream end, a downstream end, and a longitudinal lumen therebetween, and

the spring (1) comprises a compression spring having a longitudinal axis, and (2) is disposed laterally from, the valve body such that the longitudinal axis of the spring is generally parallel with the longitudinal lumen.

66. The apparatus according to any one of claims 49-52, wherein the prosthetic valve comprises:

a generally cylindrical valve body having an upstream end, a downstream end, and a longitudinal lumen therebetween; and

one or more tissue-engaging legs, protruding laterally outward from the valve body, and configured to be placed against a ventricular surface of the native valve.

67. The apparatus according to claim 66, wherein the prosthetic valve is couplable to the upstream support intracorporeally by being expanded within an opening defined by the upstream support while the upstream support is disposed against the upstream surface.

68. The apparatus according to claim 67, wherein the apparatus is configured such that the coupling of the prosthetic valve to the upstream support couples the tether to the prosthetic valve.

69. The apparatus according to claim 67, wherein the apparatus is configured to sandwich a portion of the native valve between the tissue-engaging legs and the upstream support by providing a space having a height between the tissue-engaging legs and the upstream support.

70. The apparatus according to claim 69, wherein the apparatus is configured to facilitate altering the height without altering a force on the spring.

71. The apparatus according to claim 69, wherein the apparatus is configured such that altering the height automatically alters a force on the spring.

72. The apparatus according to claim 69, wherein the apparatus is configured to facilitate altering the height by moving the valve body through the opening defined by the upstream support.

73. Apparatus for use with a native heart valve of a subject, the apparatus comprising:

a valve body;

having an upstream end, a downstream end, and a longitudinal axis therebetween,

comprising a lateral wall that circumscribes the longitudinal axis and defines a longitudinal lumen, and

comprising a valve member disposed within the lumen;

an upstream support having an inner perimeter couplable to the valve body at a first longitudinal position of the valve body, the upstream support being configured to extend radially outward from the valve body and the inner perimeter; and

a flexible sheet defining a first aperture, a second aperture and a lateral wall therebetween, a first portion of the sheet that defines the first aperture being circumferentially attached to the upstream support portion at a radius that is greater than a radius of the inner perimeter, and a second portion of the sheet that defines the second aperture being circumferentially attached to the valve body at a second longitudinal position of the valve body, such that a pocket region is defined between the sheet and at least the first longitudinal position.

74. The apparatus according to claim 73, wherein the second longitudinal position is closer to the downstream end of the valve body than is the first longitudinal position.

75. The apparatus according to claim 73, wherein the first aperture is larger than the second aperture.

76. The apparatus according to claim 73, wherein the sheet is attached to the upstream support at an outer perimeter of the upstream support.

77. The apparatus according to claim 73, wherein the sheet assumes a frustoconical shape.

78. The apparatus according to claim 73, wherein the sheet assumes a funnel shape.

79. The apparatus according to claim 73, wherein the apparatus is provided with the inner perimeter of the upstream support pre-coupled to the valve body at the first longitudinal position of the valve body.

80. The apparatus according to any one of claims 73-79, wherein the apparatus is configured such that the inner perimeter of the upstream support is intracorporeally couplable to the valve body at the first longitudinal position of the valve body.

81. Apparatus for use with a native heart valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising:

an annular upstream support defining an opening therethrough, and configured to be placed against an upstream surface of the native heart valve;

a tubular valve body having an upstream end, a downstream end and a lumen therebetween, the lumen having a first diameter, and the valve body being separated from the upstream element by a gap between the upstream end of the valve body and the upstream element;

one or more tissue-engaging elements that protrude radially outward from the valve body so as to define a second diameter that is greater than the first diameter; and

a flexible sheet shaped to define a conduit, a downstream portion of the sheet being coupled to the valve body, an upstream portion of the sheet being coupled to the upstream element, and the sheet spanning the gap.

82. The apparatus according to claim 81, further comprising at least one tether, a first portion of the tether being coupled to the valve body and a second portion of the tether being coupled to the upstream support, such that tensioning of at least a portion of the tether reduces the gap.

83. The apparatus according to claim 82, wherein the apparatus is configured such that tensioning of at least the portion of the tether rumples the sheet.

84. Apparatus for use with a native heart valve disposed between an atrium and a ventricle of a heart of a subject, the apparatus comprising:

an annular upstream element defining an opening therethrough, and configured to be placed against an upstream surface of the native heart valve;

a flexible sheet, shaped to define a conduit, and coupled to the upstream element such that the conduit is in fluid communication with the opening; and

a valve body, coupled to the flexible sheet such that the conduit provides fluid communication between the prosthetic valve and the upstream element.

85. The apparatus according to claim 84, wherein the valve body comprises:

a generally cylindrical frame shaped to define a lumen therethrough, and

a valve member coupled to the frame and disposed within the lumen.

86. The apparatus according to any one of claims 84-85, wherein the frame is separated from the upstream element by a gap, and the conduit spans the gap.

87. Apparatus, for use with a guide member that extends into a subject, the apparatus comprising:

a delivery tool, comprising a housing, the housing;

being transluminally advanceable into the subject,

shaped to define an orifice at an end of the housing, and

having a lateral wall shaped to define a slit that is continuous with the orifice;

an implant;

configured to be housed by the housing, and

comprising an eyelet that (1) is slidable over the guide member, and (2) when the implant is housed by the housing, extends through the slit and radially beyond the lateral wall such that the eyelet facilitates transluminal sliding of the implant and the housing along the guide member and into the subject,

the apparatus being configured such that, while (1) the implant remains within the subject, and (2) the guide member remains disposed through the eyelet, (1) the implant is removable from the housing via the orifice, and (2) the housing is removable from the subject.

88. The apparatus according to claim 87, wherein the implant is configured to be implanted by being intracorporeally locked to the guide member.

89. The apparatus according to any one of claims 87-88, wherein the implant has a compressed state and an expanded state, is configured to be housed by the housing while in the compressed state, and is configured to automatically expand toward the expanded state when removed from the housing.

90. A method for use with a native valve of a heart of a subject, the method comprising:

transluminally anchoring a tissue anchor to ventricular tissue of a subject using an anchor-manipulation tool, the tissue anchor being coupled to a first portion of a tether;

transluminally delivering an annular upstream support and a prosthetic valve to the heart, the prosthetic valve including (1) a valve body shaped to define a lumen therethrough, and (2) one or more tissue-engaging legs configured to protrude laterally outward from the valve body;

pressing the tissue-engaging legs in an upstream direction against a ventricular surface of the native valve by applying a force to the prosthetic valve while measuring the force;

applying, to the tether, a tension that changes a shape of a spring coupled to the tether, while observing the shape of the spring using imaging; and

at least in part responsively to the observed shape of the spring, facilitating holding of the upstream support against an upstream surface of the native valve by locking a second portion of the tether to at least one component selected from the group consisting of;

the prosthetic valve and the upstream support.

91. The method according to claim 90, wherein measuring the force comprises measuring the force using an extracorporeal force meter.

92. The method according to claim 90, wherein measuring the force comprises observing a shape of the tissue-engaging legs using imaging.

93. The method according to claim 90, wherein applying the tension comprises applying the tension while applying the force.

94. The method according to claim 90, wherein locking the second portion to the selected component comprises locking the second portion to the prosthetic valve.

95. The method according to claim 90, wherein locking the second portion to the selected component comprises locking the second portion to the upstream support.

96. The method according to claim 90, wherein locking the second portion comprises locking the second portion when the observed shape indicates that the spring is experiencing between 400 g force and 600 g force.

97. The method according to claim 90, wherein locking the second portion comprises locking the second portion subsequently to applying the tension, and applying the force comprises applying the force subsequently to locking the second portion.

98. The method according to any one of claims 90-97, wherein:

anchoring the tissue anchor coupled to the tether comprises anchoring a first tissue anchor coupled to a first tether, and applying the tension comprises applying a first tension that changes a shape of a first spring coupled to the first tether,

the method further comprises;

anchoring a second tissue anchor to the ventricular tissue, the second tissue anchor being coupled to a first portion of a second tether; and

applying, to the second tether, a second tension that changes a shape of a second spring coupled to the second tether, while observing the shape of the second spring using imaging, and

facilitating holding of the prosthetic valve against the upstream surface comprises, at least in part responsively to the observed shape of the second spring, facilitating holding of the prosthetic valve against the upstream surface by locking a second portion of the second tether to the selected at least one component.

99. The method according to claim 98, wherein facilitating holding comprises locking the second portion of the first tether and the second portion of the second tether to the selected at least one component, at least in part responsively to a ratio between tension in the first tether and tension in the second tether, the ratio being derived from the observed shape of the first spring and the observed shape of the second spring.

100. The method according to any one of claims 90-97, wherein locking comprises locking the second portion to the at least one component at least in part responsively to the observed shape.

101. The method according to claim 100, wherein locking comprises locking the second portion to the at least one component at least in part responsively to the measured force.

102. The method according to any one of claims 90-97, wherein applying the force comprises moving the valve body in an upstream direction through an opening defined by the upstream support, and the method further comprises coupling the prosthetic valve to the upstream support by expanding the valve body within the opening.

103. The method according to claim 102, wherein coupling the prosthetic valve to the upstream support comprises coupling the prosthetic valve to the upstream support at least in part responsively to the measured force.

104. A method, comprising:

transluminally advancing a plurality of tissue anchors, coupled to a respective plurality of springs, into a body of a subject;

anchoring the plurality of tissue anchors to tissue of the subject;

tensioning at least one of the springs;

using imaging, while the tension is applied to the at least one spring, observing a state of the at least one spring; and

at least in part responsively to the observed state of at least one spring, adjusting a tension on at least one of the springs.

105. A method, for use with a native valve of a heart of a subject, the method comprising:

applying a first tension to a tether that couples (a) a tissue anchor anchored to ventricular tissue of a subject, to (b) a prosthetic valve body, the tether having a length between the tissue anchor and the valve body;

by applying an atrially-directed force to the prosthetic valve body, pressing, against tissue of the native valve, a tissue-engaging element that protrudes radially from the valve body

transluminally advancing a prosthetic valve body to a native valve of the subject;

while applying the atrially-directed force, measuring;

a pressing force of the tissue-engaging element against the tissue of the native valve, and

a second tension on the tether, the second tension differing from the first tension at least in part due to the atrially-directed force; and

at least in part responsively to the measured pressing force and the measured second tension, performing an action selected from the group consisting of;

adjusting the length of the tether between the tissue anchor and the valve body, and locking the valve body to the tether.

106. A method for use with a native valve of a heart of a subject, the method comprising:

transluminally delivering a tissue anchor to a ventricle of the heart, and anchoring the tissue anchor to ventricular muscle tissue of the subject;

transluminally delivering an upstream support to an atrium of the heart, and placing the upstream support against an upstream surface of an annulus of the native valve; and

changing a shape of the upstream support by tensioning a tether coupled to upstream support and to the tissue anchor; and

extracorporeally fluoroscopically observing the shape change of the upstream support.

107. The method according to claim 106, wherein tensioning the tether coupled to the upstream support comprises tensioning a tether that is coupled to a valve body coupled to the upstream support.

108. The method according to claim 106, wherein, before the tensioning, the upstream support is generally flat annular, and changing the shape comprises making the support assume a frustoconical shape.

109. The method according to any one of claims 106-108, wherein, before the tensioning, the upstream support is frustoconical, and changing the shape comprises changing a slant of the frustoconical shape.

110. Apparatus for use with a valve of a heart of a subject, the apparatus comprising:

a transluminally-deliverable tissue anchor;

a tether, a first end thereof coupled to the tissue anchor; and

a delivery tool, comprising;

a steerable catheter having a longitudinal axis, and being transluminally deliverable to the valve, and

an obstructing element;

disposed at a longitudinal site of the catheter,

configured to extend laterally outward from the catheter, and

dimensioned, when extending laterally outward from the catheter, to inhibit movement of at least the longitudinal site through the valve by abutting tissue of the valve, and

an anchor manipulator;

reversibly couplable to the tissue anchor,

slidable through the catheter, and

configured to drive the anchor into ventricular tissue of the heart of the subject.

111. The apparatus according to claim 110, wherein the anchor manipulator is slidably coupled to the catheter such that a distal end of the anchor manipulator is slidable distally no more than a pre-determined distance from the longitudinal site.

112. The apparatus according to any one of claims 110-111, further comprising an implant, intracorporeally lockable to the tether.

113. The apparatus according to claim 112, further comprising a guide member, reversibly couplable to the tether, wherein the implant is intracorporeally slidable along the guide member toward the tether and the implant.

114. The apparatus according to claim 112, wherein the tether has exactly one locking site at which the implant is lockable to the tether.

115. The apparatus according to claim 114, wherein the exactly one locking site is disposed at a pre-determined distance from the anchor that is pre-determined at least in part dependently on a distance between the longitudinal site and a distal end of the catheter.

116. A method, comprising:

transluminally anchoring a tissue anchor to tissue of a subject using an anchor-manipulation tool;

subsequently applying to the anchor a pulling force having a given magnitude;

using imaging, observing a movement of the tissue anchor in response to the pulling force; and

at least in part responsively to the observed movement, performing an action selected from the group consisting of;

de-anchoring the tissue anchor from the tissue, and decoupling the anchor-manipulation tool from the tissue anchor.

117. Apparatus, for implantation at a native valve of a heart of a subject, the native valve being disposed between an atrium and a ventricle of the heart, the apparatus comprising:

a tubular valve body;

having an upstream portion, configured to be disposed in the atrium of the heart of the subject,

having a downstream portion, configured to be disposed in the ventricle of the subject,

having an elastic portion, disposed between the upstream portion and the downstream portion, and elastically coupling the upstream portion to the downstream portion, and

shaped to define a continuous lumen through the upstream portion, the elastic portion, and the downstream portion; and

at least one valve member, disposed in the lumen of the valve body, and configured to facilitate flow of blood of the subject from the upstream portion of the valve body to the downstream portion of the valve body, and to inhibit flow of the blood from the downstream portion of the valve body to the upstream portion of the valve body.

118. The apparatus according to claim 117, wherein the at least one valve member is coupled to the downstream portion of the valve body.

119. The apparatus according to claim 117, wherein the native valve includes a plurality of native leaflets, and wherein the downstream portion of the valve body is configured to be coupled to the native leaflets.

120. The apparatus according to claim 119, further comprising a plurality of clips, configured to facilitate the coupling of the downstream portion of the valve body to the native leaflets.

121. The apparatus according to claim 120, wherein each clip:

comprises at least two clip arms, articulatably coupled to each other, and

is reversibly closeable.

122. The apparatus according to claim 120, wherein the clips are coupled to the downstream portion of the valve body, and wherein the downstream portion of the valve body is configured to be coupled to the native leaflets by the clips being coupled to the native leaflets.

123. The apparatus according to claim 120, wherein each clip of the plurality of clips is articulatably coupled to the downstream portion of the valve body.

124. The apparatus according to claim 120, the native valve including an annulus having an upstream surface, wherein the apparatus further comprises a prosthetic valve support:

comprising (1) an upstream support portion, configured to be placed against the upstream surface of the annulus of the native valve, and (2) the plurality of clips, coupled to the upstream support portion,

shaped to define an opening therethrough that is configured to receive the prosthetic valve,

wherein the clips are configured to facilitate the coupling of the downstream portion of the valve body to the native leaflets by coupling the prosthetic valve support to the native leaflets.

125. Apparatus for use with a native valve of a heart of a subject, the native valve having a plurality of leaflets that meet at a plurality of commissures, the apparatus comprising:

at least one tissue anchor, configured to be anchored to a first site within a ventricle of the heart of the subject;

at least one longitudinal member, coupled at a distal end thereof to a respective one of the at least one tissue anchors;

an upstream support, comprising an upstream support portion configured to be slidable over the longitudinal member and placed against an upstream surface of the native valve; and

at least one locking member, configured to be slidable over a respective one of the at least one longitudinal members, and to be lockable to the respective longitudinal member such that a portion of the respective longitudinal member that is disposed between the respective anchor and the upstream support portion is longer than 1 cm.

126. The apparatus according to claim 125, wherein the longitudinal member is flexible.

127. The apparatus according to any one of claims 125-126, wherein the longitudinal member comprises a suture.

128. A method for use with a native valve of a heart of a subject, the native valve having a plurality of leaflets that meet at a first commissure and at a second commissure, the method comprising:

anchoring a first tissue anchor to a first site within a ventricle of the heart of the subject, the first tissue anchor being coupled to a distal end of a first longitudinal member;

anchoring a second tissue anchor to a second site within the ventricle of the heart of the subject, the second tissue anchor being coupled to a distal end of a second longitudinal member;

subsequently, placing at least an upstream support portion of a prosthetic valve support against an upstream surface of the native valve, the valve being disposed between the ventricle and an atrium of the heart of the subject; and

securing the upstream support portion against the upstream surface of the valve by;

coupling the upstream support portion to the first longitudinal member such that at least part of a portion of the first longitudinal member that is disposed between the upstream support portion and the first tissue anchor, is disposed between the first and second leaflets at the first commissure, and

coupling the upstream support portion to the second longitudinal member such that at least part of a portion of the second longitudinal member that is disposed between the upstream support portion and the first tissue anchor, is disposed between the first and second leaflets at the second commissure.

129. The method according to claim 128, wherein anchoring, placing, and securing comprise anchoring, securing, and placing without the use of cardiopulmonary bypass.

130. The method according to claim 128, wherein anchoring to the first site and anchoring to the second site comprise anchoring to myocardium.

131. The method according to claim 128, wherein placing the upstream support portion against the upstream surface comprises sliding the upstream support portion over at least part of the first longitudinal member.

132. The method according to claim 128, wherein coupling the upstream support portion to the first longitudinal member and to the second longitudinal member comprises coupling the upstream support portion to the first longitudinal member in the atrium of the heart of the subject, and coupling the upstream support portion to the second longitudinal member comprises coupling the upstream support portion to the second longitudinal member in the atrium of the heart of the subject.

133. The method according to claim 128, wherein the leaflets move in response to beating of the heart of the subject, and wherein securing the upstream support portion comprises securing the upstream support portion without eliminating the movement of the native leaflets.

134. The method according to claim 128, wherein coupling the upstream support portion to the first longitudinal member comprises coupling the upstream support portion to the first longitudinal member such that a length of the portion of the first longitudinal member is greater than 1 cm.

135. The method according to any one of claims 128-134, further comprising:

transluminally advancing at least the first tissue anchor to the first site while the respective longitudinal member coupled thereto is disposed within a respective tubular member; and

subsequently to anchoring the at least first tissue anchor, and before coupling the upstream support portion to the respective longitudinal member, sliding the at least first tubular member off of at least part of the respective longitudinal member.

136. The method according to claim 135, wherein sliding the at least first tubular member comprises sliding at least part of the at least first tubular member through a channel defined by a locking member, and wherein coupling the upstream support portion to the respective longitudinal member comprises locking the locking member to the respective longitudinal member by narrowing at least a portion of the channel.

137. The method according to any one of claims 128-134, wherein:

advancing the at least first tissue anchor comprises advancing the at least first tissue anchor while (1) the respective longitudinal member is reversibly coupled to a portion of a wire, and (2) the respective tubular member inhibits the portion of the wire from decoupling from the portion of the wire, and

the method further comprises facilitating decoupling of the wire from the respective longitudinal member by sliding the at least first tubular member off of the portion of the wire.

138. The method according to claim 137, wherein:

advancing the at least first tissue anchor comprises advancing the at least first tissue anchor while (1) the respective longitudinal member is shaped to define a loop, and is coupled to the portion of the wire by the portion of the wire being threaded through the loop, and (2) the respective tubular member inhibits the portion of the wire from unthreading from the loop, and

facilitating decoupling of the wire from the respective longitudinal member comprises facilitating unthreading of the wire from the loop by sliding the at least first tubular member off of the portion of the wire.

139. The method according to claim 138, wherein sliding the at least first tubular member off of the portion of the wire comprises sliding the at least first tubular member off of the portion of the wire by applying less than 500 g of pulling force to the at least first tubular member.

140. The method according to claim 139, wherein applying less than 500 g of pulling force to the at least first tubular member comprises applying less than 300 g of pulling force to the at least first tubular member.

141. The method according to any one of claims 128-134, further comprising, subsequently to securing the upstream support portion, coupling a prosthetic valve to the prosthetic valve support.

142. The method according to claim 141, wherein the upstream support portion has an inner edge that defines an opening through the upstream support portion, and wherein coupling the prosthetic valve to the prosthetic valve support comprises placing at least a portion of the prosthetic valve within the opening, and expanding at least the portion of the prosthetic valve such that at least the portion of the prosthetic valve applies a radially-expansive force against the inner edge of the upstream support portion.

143. The method according to claim 141, wherein the prosthetic valve includes one or more tissue-engaging elements, each of the one or more tissue-engaging elements including at least two arms, and wherein the method further comprises, subsequent to securing the upstream support portion, coupling the prosthetic valve to at least one of the leaflets by sandwiching the at least one of the leaflets between the at least clip arms of the one or more tissue-engaging elements.

144. The method according to claim 143, wherein coupling the prosthetic valve to the at least one of the leaflets comprises coupling the prosthetic valve to the at least one of the leaflets before coupling the prosthetic valve to the prosthetic valve support.

145. The method according to claim 143, wherein:

the prosthetic valve includes a valve body, having an outer surface,

the at least two arms include a first arm and a second arm, the first arm being longer than the second arm, and

the method further comprises;

delivering, within a delivery tube, the prosthetic valve in a delivery configuration thereof, in which the first arm and the second arm are constrained against the outer surface of the valve body;

facilitating deflection of the first arm away from the outer surface of the prosthetic valve, by advancing a first portion of the prosthetic valve out of the delivery tube such that the first arm automatically deflects away from the outer surface of the prosthetic valve; and

facilitating deflection of the second arm away from the outer surface of the prosthetic valve, by advancing a second portion of the prosthetic valve out of the delivery tube such that the second arm automatically deflects away from the outer surface of the prosthetic valve.

146. The method according to claim 145, wherein:

facilitating deflection of the first arm comprises facilitating deflection of the first arm a first angle from the outer surface of the prosthetic valve, and

the method further comprises facilitating deflection of the first arm away from the outer surface of the prosthetic valve a second angle that is greater than the first angle, by applying a force to the first arm using the delivery tube;

subsequently to facilitating deflection of the first arm the first angle, and

prior to facilitating deflection of the second arm.

147. The method according to claim 146, wherein applying the force to the first arm using the delivery tube comprises pushing on the first arm by sliding the delivery tube over at least part of the prosthetic valve.

148. Apparatus for use with a body of a subject, the apparatus comprising:

at least a first implantable member;

a first longitudinal member, coupled at a distal end thereof to the first implantable member;

a second longitudinal member, at least a portion of the second longitudinal member being reversibly couplable to the first longitudinal member; and

a tubular member;

slidable over the first and second longitudinal members,

shaped to define a lumen therethrough, and

configured, when the portion of the second longitudinal member is (1) coupled to the first longitudinal member, and (2) disposed within the lumen of the tubular member, to inhibit decoupling of the portion of the second longitudinal member from the first longitudinal member.

149. The apparatus according to claim 148, wherein the portion of the second longitudinal member is configured, when (1) the portion of the second longitudinal member is coupled to the first longitudinal member, and (2) the portion of the second longitudinal member is disposed outside of the lumen of the tubular member, to be decouplable from the first longitudinal member by the second longitudinal member being pulled away from the first longitudinal member.

150. The apparatus according to claim 148, wherein at least one longitudinal member selected from the group consisting of:

the first longitudinal member and the second longitudinal member, is flexible.

151. The apparatus according to claim 148, wherein the tubular member is more rigid than the first longitudinal member.

152. The apparatus according to claim 148, wherein the tubular member fits snugly over at least the portion of the second longitudinal member.

153. The apparatus according to claim 148, wherein the first implantable member comprises a tissue anchor, configured to be anchored to a tissue of the subject.

154. The apparatus according to any one of claims 148-153, further comprising a second implantable member, slidable over the tubular member, and couplable to the first longitudinal member while the portion of the second longitudinal member is coupled to the first longitudinal member.

155. The apparatus according to claim 154, wherein the portion of the second longitudinal member is reversibly couplable to the first longitudinal member at a first site of the first longitudinal member, and wherein the second implantable member is couplable to the first longitudinal member at a second site of the first longitudinal member that is distal to the first site of the longitudinal member.

156. The apparatus according to claim 154, further comprising a locking member having an unlocked state and a locked state, and configured to be slid over the tubular member in the unlocked state and to be locked to the first longitudinal member by being transitioned to the locked state.

157. The apparatus according to claim 156, wherein the locking member is configured to facilitate coupling of the second implantable member to the first longitudinal member.

158. The apparatus according to claim 156, wherein the locking member is configured to be coupled to the first longitudinal member at least 1 cm away from the first implantable member.

159. Apparatus for use at a native valve of a heart of a subject, the apparatus comprising:

a tissue anchor, configured to be transluminally, transcatheterally advanced to a ventricle of the heart of the subject, and to be coupled to tissue of the ventricle;

a longitudinal member, coupled at a distal end thereof to the tissue anchor;

a wire, a portion of the wire being reversibly couplable to the longitudinal member;

a tubular member;

slidable over the longitudinal member and the wire,

shaped to define a lumen therethrough, and

configured, when the portion of the wire is (1) coupled to the longitudinal member, and (2) disposed within the lumen of the tubular member, to inhibit decoupling of the portion of the wire from the longitudinal member;

a prosthetic valve support comprising an upstream support portion slidable over the tubular member, and to be placed against an upstream surface of an annulus of the native valve by sliding over the tubular member; and

a locking member, slidable over the tubular element and lockable to the longitudinal member.

160. The apparatus according to claim 159, wherein the locking member is configured to be locked to the longitudinal member at a site of the longitudinal member that is distal to a site of the longitudinal member to which the portion of the wire is reversibly couplable.

161. The apparatus according to claim 159, wherein the tubular member is configured to be slid out of the locking member before the locking member is locked to the longitudinal member.

162. The apparatus according to any one of claims 159-161, further comprising a control rod, slidable over the tubular member, the locking member being reversibly coupled to a control rod, the control rod being configured to restrain the locking member in an unlocked configuration thereof, and to facilitate locking of the locking member by ceasing to restrain the locking member in the unlocked configuration.

163. The apparatus according to claim 162, wherein the control rod is configured to decouple from the locking member when the control rod ceases to restrain the locking member in the unlocked configuration thereof.

164. The apparatus according to claim 162, wherein the control rod is configured to cease to restrain the locking member in the unlocked configuration thereof by the control rod being rotated with respect to the locking member.

165. The apparatus according to claim 162, wherein:

the prosthetic valve support is shaped to define a hole through which the tubular member is slidable,

at least while the control rod is coupled to the locking member, the control rod is not slidable through the hole defined by the prosthetic valve support, and the control rod is configured to facilitate the sliding of the prosthetic valve support over the tubular member by pushing the prosthetic valve support over the tubular member.