ADJUSTABLE PERCUTANEOUS ANNULOPLASTY DEVICES, DELIVERY SYSTEMS, A METHOD FOR PERCUTANEOUSLY DEPLOYING AN ANNULOPLASTY DEVICEA AND A METHOD PERFORMED BY ONE OR MORE PROCESSING DEVICES

Abstract

An adjustable annuloplasty device (1) which comprises a tubular, longitudinally extending cage (2) having a basically annular shape or being adapted to be brought into an annular shape upon release from a delivery device (3). The annuloplasty device additionally comprises a separate, tubular, longitudinally extending base (4) having at least a part of the basically annular shape of the cage (2) or being adapted to be brought into at least partially into the annular shape of the cage (2) upon release from a delivery device. The tubular cage (2) is attachable to the base (4) and the base (4) is flexible such that the annular shape of the base (4) is adjustable.

Claims

1-65. (canceled)

66. An adjustable percutaneous annuloplasty device comprising: a tubular, longitudinally extending cage having a basically annular shape or being adapted to be brought into an annular shape upon release from a delivery device, a separate, longitudinally extending base having at least a part of the basically annular shape of the cage or being adapted to be brought, at least partially, into the annular shape of the cage upon release from a delivery device, wherein the cage is attachable to the base, the base comprises at least one flexible element such that the annular shape of the base is adjustable, and the flexible element allows at least one of an expansion and compression along a longitudinal direction of the base.

67. The adjustable annuloplasty device according to claim 66, wherein the cage and the base are independently insertable to an implantation site and adapted to be connected to each other at the implantation site.

68. The adjustable annuloplasty device according to claim 66, wherein the base additionally has at least two rigid elements which are connected by a flexible element.

69. The adjustable annuloplasty device according to claim 68, wherein the base comprises alternating rigid and flexible elements.

70. The adjustable annuloplasty device according to claim 68, wherein the at least one rigid element is movably arranged within the base such that the at least one rigid element is pushable towards an inner annular area.

71. The adjustable annuloplasty device according to claim 68, wherein the at least one rigid element includes an interface, for a connection to the cage.

72. The adjustable annuloplasty device according to claim 66, wherein the cage is adjustable, the cage comprises an outer and an inner wall and at least one portion of the outer wall is more rigid than opposite portion(s) of the inner wall, the inner wall is arranged nearer to an inside area defined by the annular shape than the outer wall such that the inner wall is adapted to be displaced inwardly, at least along less rigid portion(s) of the circumference, upon actuation by at least one actuation element while the outer wall remains basically constant.

73. The adjustable annuloplasty device according to claim 72, wherein the outer wall is more rigid along its entire length than the at least a part of the length of the inner wall.

74. The adjustable annuloplasty device according to claim 66, wherein the cage comprises anchors for at least one of engaging an annulus and for connecting the cage to the annular base.

75. The adjustable annuloplasty device according to claim 66, wherein the base comprises anchors for at least one of engaging an annulus and for connecting the cage to the annular base.

76. The adjustable annuloplasty device according to claim 74, wherein the anchors comprise a shape memory alloy.

77. The adjustable annuloplasty device according to claim 76, wherein the anchors comprise pins with a longitudinally extending body part and a tip.

78. The adjustable annuloplasty device according to claim 68, wherein the at least one rigid element includes an opening, and the anchors extend through or are adapted to extend through said opening.

79. The adjustable annuloplasty device according to claim 74, wherein the at least one rigid element includes an opening, and the anchors extend through or are adapted to extend through said opening.

80. The adjustable annuloplasty device according to claim 66, wherein the annuloplasty device additionally comprises a transmission line for adjusting at least one of the cage and annulus base.

81. An adjustable percutaneously annuloplasty device comprising: a longitudinally extending base having a basically annular shape and a deployed state and an undeployed state, wherein the base is flexible such that the annular shape of the base is adjustable at least one of during and after implantation, and the base comprises a shape memory alloy such that in the deployed state, upon release from a delivery device, the base has an annular shape, and the base includes at least one flexible element, which allows at least one of an expansion and compression along a longitudinal direction of the base.

82. The adjustable annuloplasty device according to claim 81, wherein, the base includes at least one flexible element and at least two rigid elements, which are connected by the flexible element, and the flexible element allows at least one of an expansion and compression along a longitudinal direction of the base.

83. The adjustable annuloplasty device according to claim 82, wherein the base comprises alternating rigid and flexible elements.

84. The adjustable annuloplasty device according to claim 82, wherein the at least one rigid element is moveable arranged within the base such that the at least one rigid element is pushable towards an inner annular area.

85. The adjustable annuloplasty device according to claim 82, wherein the at least one rigid element includes an interface for a connection to a cage.

86. The adjustable annuloplasty device according to claim 82, wherein the rigid element comprises a first pad, which extends along a plane of the annular shape and a second pad which is angled relative to the first pad.

87. The adjustable annuloplasty device according to claim 86, wherein the flexible element comprises a wire and the wire comprises a first and second end and each end is a connected to a first surface of a rigid element.

88. The adjustable annuloplasty device according to claim 66, wherein the annuloplasty device comprises at least one commissural anchor for fixating the base to an annulus.

89. The adjustable annuloplasty device according to claim 88, wherein the commissural anchors comprises a shape memory alloy such that once a sleeve covering the commissural anchor is removed, the anchors are deployed and adapted to penetrate the native tissue of the annulus so to realize two commissural fixations.

90. A delivery system for percutaneously implanting an annuloplasty device comprising an outer sleeve, at least one commissural anchor, an inner sleeve, and an annuloplasty device, wherein the annuloplasty device is arranged or arrangeable within the inner sleeve, and the commissural anchor is disposed between the inner and the outer sleeve.

91. The delivery system according to claim 90, wherein the annuloplasty device comprises a cage and a base, and the cage and the base are arranged or arrangeable in the inner sleeve.

92. The delivery system according to claim 90, wherein the base at least partially covers an outer surface of the cage.

93. The delivery system according to claim 90, wherein a first commissural anchor is disposed at a distal end of the delivery system.

94. The delivery system according to claim 90, wherein the delivery system further comprises a delivery tube, and the outer sleeve is disposed within the delivery tube.

95. The delivery system according to claim 94, wherein the delivery tube is more rigid than at least one of the outer and the inner sleeve.

96. The delivery system according to claim 90, wherein a second commissural anchor is disposed at an intermediary section of the delivery system.

97. The delivery system for an annuloplasty device, comprising a delivery tube and a second part adapted to be transported throug h the outer sleeve, wherein the system comprises a position sensor for measuring a relative position of the second part in relation to the outer sleeve.

98. The delivery system for an annuloplasty device according to claim 97, wherein the sensor is disposed at a distal port of the delivery system.

99. The delivery system for an annuloplasty device according to claim 97, wherein the second part is at least one of: a catheter, a sleeve, an annuloplasty device, and a balloon.

100. The delivery system for an annuloplasty device according to claim 97, wherein the system comprises a monitor for indicating a current position of the second part to a user.

Description

[0110] Non-limiting embodiments of the invention are described, by way of example only, with respect to the accompanying drawings, in which:

[0111] FIG. 1: is a schematic perspective view of a delivery system with an annuloplasty device during a first step of implantation of an annuloplasty device,

[0112] FIG. 2: is a first schematic perspective view of the delivery system with the annuloplasty device during a second step of implantation of an annuloplasty device,

[0113] FIG. 3: is a second schematic perspective view of the delivery system with the annuloplasty device during the second step of implantation of an annuloplasty device,

[0114] FIG. 4: is a first schematic perspective view of the delivery system with the annuloplasty device during a third step of implantation of an annuloplasty device,

[0115] FIG. 5: is a second schematic perspective view of the delivery system with the annuloplasty device during the third step of implantation of an annuloplasty device,

[0116] FIG. 6: is a first schematic perspective view of the delivery system with the annuloplasty device during a fourth step of implantation of an annuloplasty device,

[0117] FIG. 7: is a second schematic perspective view of the delivery system with the annuloplasty device during a fifth step of implantation of an annuloplasty device,

[0118] FIG. 8: is a first schematic perspective view of the delivery system with the annuloplasty device during a sixth step of implantation of an annuloplasty device,

[0119] FIG. 9: is a second schematic perspective view of the delivery system with the annuloplasty device during the sixth step of implantation of an annuloplasty device,

[0120] FIG. 10: is a schematic perspective view of the implanted annuloplasty device and

[0121] FIG. 11: is a schematic drawing of a mitral valve as seen from the left atrium.

[0122] FIG. 11 shows a schematic drawing of a mitral valve as seen from the left atrium. The mitral valve 100 comprises an anterior leaflet 101 and a posterior leaflet 102. Both leaflets 101, 102, extend into the left ventricle, where they co-apt. The leaflets 101, and 102, are biased towards the left ventricle and kept from prolapsing into the left atrium by chordae. Around the circumference of the mitral valve 100, the leaflets 101, 102 are integral with the valve annulus. The anterior and the posterior leaflet each comprise three scallops. The anterior scallops A1, A2, A3 and the posterior scallops P1, P2, P3 are positioned across each other such that in a healthy valve A1 and P1, A2 and P2, and, A3 and P3 coapt. Certain medical conditions may reduce a coaptation between the leaflets 101 and 102. As a result of the insufficient coaptation, there may be flow from the left ventricle to the left atrium. This type of blood flow is called regurgitation.

[0123] In order to inhibit the regurgitation, the valve annulus may be re-shaped. A position where the two leaflets end, 103 and 104, is called a commissure. A distance between the two commissures is an inter-commissural distance 105. Further, an anterior-posterior distance 106 is defined by the positions of two points 107 and 108. The point 107 corresponds to a position of the A2 scallop on the annulus. The point 108 corresponds to a position of the P2 scallop on the annulus.

[0124] To re-shape the annulus a physician can reduce the distance 106 between the anterior leaflet and the posterior leaflet to increase a coaptation area. Additionally the physician may also bring the commissures closer together, i.e. reduce the inter-commissural distance 105.

[0125] FIG. 1 shows a schematic drawing of a delivery system 3 with an annuloplasty device 1 and a delivery device during a first step of implantation of the annuloplasty device 1. The delivery device includes a delivery tube 23, an outer sleeve 21 and an inner sleeve 22. FIG. 1 shows the first step of implantation, in which the annuloplasty device 1 is released from a distal end 51 of the delivery tube 23. Within the delivery tube 23 the outer sleeve 21 and the inner sleeve 22 are disposed. The inner sleeve 22 is placed within the outer sleeve 21. The delivery tube 23 is relatively stiff compared to the inner and outer sleeves wherein inner and outer tubes are made of a softer material such that they may assume an annular shape. However, the delivery tube 23 is adapted for the transatrial approach. Thus the tube is flexible enough for the sharp turns in the aortic arch and through a left ventricle. In between the inner sleeve 22 and the outer sleeve 21, a first commissural anchor 9 is disposed at a distal end 50 of the outer tube 21. The first commissural anchor 9 is later placed in proximity to the anterior commissure 103 of the native valve and thus called anterior commissural anchor 9 in the following. Within the inner tube 22 a base 4 is held. The base 4 comprises of alternating rigid elements 6 and flexible elements 5.

[0126] Before inner and outer sleeve 21, 22 are released from the delivery tube 23, the delivery tube 23 is brought to a suitable location, i.e. a mitral valve annulus. The delivery system 3 is brought to the mitral valve annulus either through a transseptal or a trans-femoral or a trans-apical approach. The transseptal approach is preferred. Once a distal end 51 of the delivery tube 23 is in a suitable location, i.e. the mitral valve annulus, the release procedure of the annuloplasty device 1 is initiated by exteriorizing the inner and outer sleeves 21, 22 simultaneously as shown in FIG. 1.

[0127] The rigid element 6 includes a plate which comprises a lower pad 31 and an angled pad 32. In an implanted position, the lower pad 31 is anchored to tissue of a native valve annulus. The pads 31, 32 are made from the single plate which is bent in a middle part. The rigid elements 6 are interconnected by the flexible elements 5. As can be seen from FIG. 1, the lower pad 31 comprises a U-shaped cut out. The U-shaped cut out defines anchors 8.

[0128] FIGS. 2 and 3 show a first and a second schematic view of the delivery system 3 with the annuloplasty device 1 during a second step of implantation. As inner and outer sleeves 21, 22 are further pushed out of the delivery tube 23, the entire base 5 is released from the delivery tube 23. The base 5 is made from a shape memory alloy nitinol. The shape memory alloy is biased such that upon release the base 5 assumes a D-shape. Each flexible element 5 consists of a wire 52 which has an undulating shape. The wires 52 are made from a shape memory of material such that a selection of the wires expands. As a result, outer sleeve, inner sleeve and base assume a D-shape, once they are released from the stiffer delivery tube 23. The angled pad 32 faces towards the inner annular area 24. In the D-shape a distal end 34 of the base 4 and the anterior commissural anchor 9 are in contact which a proximal part 35 of the outer sleeve 21.

[0129] Further to the distally disposed commissural anchor 9, the delivery system comprises a second commissural anchor 20. The second commissural anchor 20 is located at an intermediary part 53 of the base is also disposed between inner and outer sleeve 21, 22. The second commissural anchor 20 is later placed in proximity to the posterior commissure 104 of the native valve and thus called posterior commissural anchor 20 in the following. Once the base 5 assumes the D-shape upon leaving delivery tube 23, the first and second commissural anchors are located at the corners of the D-shape.

[0130] During implantation the D-shape is aligned with the annulus of the mitral valve. The anterior commissural anchor 9 is arranged such that the anterior commissural anchor 9 is placed on the anterior commissure 103 of a native valve annulus. Then the outer sleeve 21 is retracted.

[0131] FIGS. 4 and 5 show a first and second schematic view of the delivery system 3 with the annuloplasty device 1 during a third step of implantation. FIGS. 4 and 5 show the delivery system 3 after the retraction of the outer sleeve 21. Both commissural anchors 9 and 20, are made of a shape memory alloy. The commissural anchors 9, 20 have a ring shape with cut outs. The cut outs extend a circumference of the commissural anchors 9 and 20 and define hooks 25, 26. As long as the commissural anchors 9 and 20 are held in the outer sleeve 21, these fingers are held within the annular shape of the commissural anchors 9 and 20. However, after retraction of the outer sleeve, the hooks 25, 26 bend out of the annular shape and fixate the commissural anchors 9, 20 in a tissue of the natural valve annulus. The retraction of the outer sleeve 21 is made in two steps. In a first step, under imaging guidance and after the anterior commissural anchor 9 is aligned with the anterior commissure 103 of the mitral valve (see FIG. 11), the anterior commissural anchor 9 is released from the distal end 50 of the outer sleeve 21. Then, a position of the posterior commissural anchor 20 is found by pulling or pushing the delivery system forwards or backwards until the posterior commissural anchor 20 is in a desired position. Thus, while the anterior commissural anchor 9 is in a fixed position, the position of the posterior commissural anchor 20 may still be freely defined. Thereby, an inter-commissural distance 105 may be set according to a desired geometry after the annuloplasty. Once a suitable position is found, the outer sleeve 21 is fully retracted. Thereby, the hooks 26 of the posterior commissural anchor 20 are also released.

[0132] Then in a next step, the anterior-posterior distance is adjusted for a first time. Base 4 is fixedly attached to the first commissural anchor 9. Base 4 is not fixedly attached to the posterior commissural anchor 20. The base extends through the ring shape posterior commissural anchor 20. Thus, the base may be pushed distally and proximally through the posterior commissural anchor 20 which acts as a gate. The interior posterior distance is then adjusted by pulling or pushing the inner sleeve creating a smaller or larger radius of a round part of the D-shape. Thereby, the size of the native valve annulus is adjusted. Thereafter a cage 2 is advanced through the inner sleeve 22.

[0133] FIG. 6 shows a schematic view of the delivery system 3 and the annuloplasty device 1 during a fourth step of implantation of the annuloplasty device 1. The cage 2 is advanced until its distal end 10 is distally beyond a distal end of the base. FIG. 6 shows the delivery system 3, once the cage 2 has been fully advanced in the inner sleeve 22. As can be seen from FIGS. 4 and 5, the base 4 has an L-shape, which covers a part of an inner surface of the inner sleeve 22.

[0134] The cage 2 has a tubular shape which defines an inner lumen. Thus, the cage 2 may be advanced through the lumen of the inner sleeve 22 while the base is in the lumen. The cage 2 comprises an outer wall 12 and an inner wall 13. Inner and outer wall 12, 13 are defined with regard to the annular shape of the annuloplasty device 1. Thus the inner wall 13 is a part of the cage 2 which faces an inner annular area 24 and the outside wall as a part of the wall which faces an outside area 15. The outer wall 12 is defined by two longitudinally extending struts 29, which are interconnected by scales 30. The longitudinally extending struts 29 define a length of the cage 2 and prohibit an extension and/or compression the base 4. The inner wall 13 comprises undulating struts which extend around the circumference of the tubular cage. These undulating struts may be expanded towards the inner annular area, as will be explained in greater details in FIGS. 8 to 10.

[0135] Like the base 4, the cage 2 is made from a nitinol and assumes upon exteriorization of the delivery tube 23 a D-shape, which facilitates advancing the cage 2.

[0136] FIG. 7 shows a schematic view of the delivery system of the annuloplasty device during a fifth step of implantation of the annuloplasty device 1. In FIG. 7 the inner sleeve 22 is partially retracted. The cage is advanced with a transmission line 18, which is attached to a proximal end 11 of the cage 2.

[0137] FIGS. 8 and 9 show a first and a second schematic view of the delivery system 3 with the annuloplasty device 1 during a sixth step of implantation of the annuloplasty device 1. Once cage 2 is fully advanced, the inner sleeve 22 may be withdrawn. In FIG. 7 the inner sleeve 22 is partially withdrawn. During withdrawal of inner sleeve 22 anchors 8 are deployed. The anchors include an elongate body part 42 and a sharp tip 41. When the anchors are deployed, they pivot outwardly into the tissue of the native valve.

[0138] During deployment the native valve annulus may be shaped. The anchors are deployed starting from a distal end. After first anchor 8 is placed a user pushes and/or pulls the delivery system to adjust a shape of the annulus. Then a second anchor is deployed. After the second anchor 8 is deployed the user may push or pull the delivery system again to align a position of the second anchor the corresponding tissue. The following anchors 8 are deployed in the same fashion until all anchors 8 are anchored in the native valve annulus and the native valve annulus is reshaped. During deployment, the anchors 8 are deployed along an inner edge of the annuloplasty device.

[0139] When the inner sleeve is retracted beyond the distal end of the base 4 and the cage 2, the distal end of the base 4 or the cage 2 or the anterior commissural anchor 9 interlocks with a proximal portion of the base or cage.

[0140] Once all anchors 8 are deployed, an initial shape of the annulus is set. This reshaping may be sufficient in order to inhibit regurgitation. However, if there is still residual regurgitation the annuloplasty device includes further adjustability. Furthermore, some patients, functional patients develop regurgitation after months or years of implantation of the annuloplasty device.

[0141] In both cases, the device is adjusted by advancing a balloon catheter 38 through the tubular transmission line 18 into the tubular shape of the cage 2. The balloon catheter 38 comprises a balloon 19 and a tube 39 through which the balloon 19 may be inflated. As can be seen from FIGS. 8 and 9, the outer wall 12 with its longitudinal struts 29 and scales 30 has a higher rigidity than the inner wall 12 with its undulating struts. Thus, if the balloon 19 of the balloon catheter 38 is expanded, the inner wall 12 is pushed towards the inner annular area 24.

[0142] The anchors 8 are deployed along an inner edge of the annuloplasty device 1. Upon expanding the balloon catheter 38, the anchors 8 and the annular tissue in which they are anchored are moved simultaneously inwardly.

[0143] Thereby, the angled pad 32 and with it the lower pad 31 and also anchors 8 are also pushed towards the inner annular area 24. As a result, the annuloplasty is adjusted by pushing only a section towards the inner annular area. The inner wall 13 is less rigid than the outer wall 12 along its entire length and thus the annuloplasty device 1 is adjusted around its entire annular shape is desired until there is no residual regurgitation.

[0144] FIG. 10 shows a schematic view of the implanted annuloplasty device. In FIG. 10 the balloon catheter 39 is removed from the annuloplasty device 1. FIG. 10 shows a final implanted shape of the implanted annuloplasty device 1. A transmission line 18 is attached to the cage. The transmission line 18 is a tube whose inner lumen is distally connected to a cage.

[0145] A user may insert a balloon catheter again into the transmission at a later time to readjust the annuloplasty device 1, if necessary.

[0146] A distal part of the delivery tube 23 comprises a linear encoder. The linear encoder measures a relative position between delivery tube 23 and outer sleeve 21. Also a second linear encoder measures a relative position between the inner sleeve 22 and the delivery tube 23. A third encoder measures a relative position between the transmission line 18 and the balloon catheter 39.

[0147] During implantation the measured relative positions are displayed to a surgeon. The relative positions indicate to the surgeon where the respective device is located, how much further they need to be advanced and in which shape the annuloplasty device currently is.

[0148] To aid the surgeon, their positions are visualised in a 3-D animation based on the shape memory properties of the annuloplasty device. The 3-D animation shows how the shape memory parts of the annuloplasty device assume their form without the need of further imaging technology. The 3-D animation shows the measured position in combination with 3-D model data with an imaging fusion.

[0149] Furthermore the 3-D data may be combined with imaging data from an echocardiography system. The echocardiography system provides fluoroscopic imaging data. The fluoroscopic imaging data is overlapped with the 3-D animation providing an augmented reality image or stream.