US6986775B2 — Devices and methods for heart valve repair

Claim 1

Independent Claim 170 words

A method constricting a heart valve annulus, the method comprising: introducing a tethered clip assembly to the annulus, the tethered clip assembly comprising a plurality of clips coupled with a tether, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether, the introducing step comprising passing the tethered clip assembly through an elongate shaft and a curved distal end portion of the elongate shaft; securing individual clips at circumferentially spaced-apart locations about at least a portion of the annulus including the first clip, a series of intermediate clips, and a terminal clip; cinching the tether through the clips to circumferentially tighten the annulus; and preventing the terminal clip from moving proximally past a chosen location along the tether after the cinching step.

Claim 2

Independent Claim 170 words

A method constricting a heart valve annulus, the method comprising: introducing a tethered clip assembly to the annulus, the tethered clip assembly comprising a plurality of clips coupled with a tether, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether, the introducing step comprising passing the tethered clip assembly through an elongate shaft and a curved distal end portion of the elongate shaft; securing individual clips at circumferentially spaced-apart locations about at least a portion of the annulus including the first clip, a series of intermediate clips, and a terminal clip; cinching the tether through the clips to circumferentially tighten the annulus; and preventing the terminal clip from moving proximally past a chosen location along the tether after the cinching step.

Claim 3

Dependent Claim 58 words

A method as in claim 1 , wherein the tether is coupled to at least the intermediate and terminal clips through an eyelet in the clips and wherein deforming at least the terminal clip comprises applying force to the eyelet on the clip(s) to reduce the inner diameter of the eyelet and secure the tether within the eyelet.

Claim 4

Dependent Claim 30 words

A method as in claim 1 , wherein introducing the plurality of clips comprises advancing a tethered clip applicator through an incision in a wall or septum of the heart.

Claim 5

Dependent Claim 22 words

A method as in claim 3 , wherein advancing comprises advancing through an incision in a left atrial wall of the heart.

Claim 6

Dependent Claim 37 words

A method as in claim 3 , further comprising placing an instrument introduction device through the incision in the wall of the heart, wherein advancing the clip applicator comprises advancing the applicator through the instrument introduction device.

Claim 7

Dependent Claim 14 words

A method as in claim 1 , wherein the individual clips are secured successively.

Claim 8

Dependent Claim 19 words

A method as in claim 1 , wherein the individual clips are simultaneously secured to the circumferentially spaced-apart locations.

Claim 9

Dependent Claim 16 words

A method as in claim 1 , wherein cinching comprises applying tensile force to the tether.

Claim 10

Dependent Claim 25 words

A method as in claim 8 , wherein applying tensile force comprises pulling the tether proximally through an applicator which has introduced the terminal clip.

Claim 11

Dependent Claim 26 words

A method as in claim 1 , wherein the preventing step comprises deforming the terminal clip so that the terminal clip becomes fixed to the tether.

Claim 12

Dependent Claim 25 words

A method as in claim 1 , further comprising securing at least one tether anchor to the annulus adjacent to the terminal clip after cinching.

Claim 13

Dependent Claim 19 words

A method as in claim 11 , wherein securing the tether anchor comprises securing a rivet to the annulus.

Claim 14

Dependent Claim 12 words

A method as in claim 1 , further comprising visualizing the annulus.

Claim 15

Dependent Claim 33 words

A method as in claim 13 , wherein visualizing is performed using visualization device comprising at least one of an ultrasound device, and angioscopic device, a transesophageal echocardiogram device and a fluoroscopic device.

Claim 16

Dependent Claim 23 words

A method as in claim 13 , wherein visualization is performed using an ultrasound device comprising a gel-containing cone for enhancing ultrasound visualization.

Claim 17

Dependent Claim 31 words

A method as in claim 13 , wherein visualizing comprises using a real-time Doppler ultrasound device to visualize a regurgitant flow across the heart valve during at least the cinching step.

Claim 18

Dependent Claim 34 words

A method as in claim 1 , further comprising: visualization a reduction in the regurgitant flow during the cinching step; and selecting an amount of cinching based on the reduction in the regurgitant flow.

Claim 19

Dependent Claim 39 words

A method as in claim 13 , wherein the visualization step is carried out using at least one visualization device coupled with an applicator device for introducing the tethered clip assembly and securing the clips at circumferentially spaced-apart locations.

Claim 20

Dependent Claim 41 words

A method as in claim 18 , wherein the at least one visualization device comprises an angioscope having a viewing end within or adjacent to a lens, bubble or inflatable balloon which displaces blood to permit viewing in the beating heart.

Claim 21

Dependent Claim 24 words

A method as in claim 1 , wherein the introducing, securing and cinching steps are performed as part of an open heart surgical procedure.

Claim 22

Dependent Claim 20 words

A method as in claim 1 , wherein the introducing, securing and cinching steps are performed without stopping the heart.

Claim 23

Dependent Claim 23 words

A method as in claim 1 , wherein the introducing, securing and cinching steps are performed through one or more minimally invasive incisions.

Claim 24

Dependent Claim 17 words

A method as in claim 1 , wherein the introducing, securing and cinching steps are performed intravascularly.

Claim 25

Dependent Claim 21 words

A method as in claim 1 , wherein the introducing, securing and cinching steps are performed on a mitral valve annulus.

Claim 26

Dependent Claim 21 words

A method as in claim 1 , wherein the introducing, securing and cinching steps are performed on a tricuspid valve annulus.

Claim 27

Dependent Claim 21 words

A method as in claim 1 , further comprising stabilizing the annulus relative to the heart prior to introducing the clips.

Claim 28

Dependent Claim 35 words

A method as in claim 26 , wherein stabilizing comprises introducing at least a first stabilizing ring beneath the valve leaflets, wherein the ring engages the intersection between the leaflet and the interior ventricular wall.

Claim 29

Dependent Claim 26 words

A method as in claim 1 , wherein the introducing step is carried out with the first clip fixed to the lead end of the tether.

Claim 30

Independent Claim 201 words

A method for constricting a heart valve annulus, the method comprising: introducing a tethered clip assembly to the annulus, the tethered clip assembly comprising a plurality of clips coupled with a tether, the tether comprising parallel segments, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether; securing individual clips of the tethered clip assembly at circumferentially spaced-apart locations about at least a portion of the annulus, the parallel segments of the tether being coupled to at least the intermediate and terminal clips through first and second eyelets in the clips; cinching a tether through the clips to circumferentially tighten the annulus; and preventing the terminal clip from moving proximally past a chosen location along the tether after the cinching step by applying force to the first and second eyelets on the terminal clip to reduce the inner diameter of the first and second eyelets and secure the tether to the terminal clip.

Claim 31

Independent Claim 201 words

A method for constricting a heart valve annulus, the method comprising: introducing a tethered clip assembly to the annulus, the tethered clip assembly comprising a plurality of clips coupled with a tether, the tether comprising parallel segments, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether; securing individual clips of the tethered clip assembly at circumferentially spaced-apart locations about at least a portion of the annulus, the parallel segments of the tether being coupled to at least the intermediate and terminal clips through first and second eyelets in the clips; cinching a tether through the clips to circumferentially tighten the annulus; and preventing the terminal clip from moving proximally past a chosen location along the tether after the cinching step by applying force to the first and second eyelets on the terminal clip to reduce the inner diameter of the first and second eyelets and secure the tether to the terminal clip.

Claim 32

Independent Claim 183 words

A method for constricting a heart valve annulus, the method comprising: placing an instrument introduction device through an incision in the left atrial wall of the heart; introducing a tethered clip assembly to the annulus by advancing a tethered clip applicator through the instrument introduction device, the tethered clip assembly comprising a plurality of clips coupled with a tether, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether; securing the introduction device to an epicardial surface of the heart wall before the advancing step; securing individual clips of the tethered clip assembly at circumferentially spaced-apart locations about at least a portion of the annulus; cinching the tether through the clips to circumferentially tighten the annulus; and preventing the terminal clip from moving proximally past a chosen location along the tether after the cinching step.

Claim 33

Independent Claim 183 words

A method for constricting a heart valve annulus, the method comprising: placing an instrument introduction device through an incision in the left atrial wall of the heart; introducing a tethered clip assembly to the annulus by advancing a tethered clip applicator through the instrument introduction device, the tethered clip assembly comprising a plurality of clips coupled with a tether, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether; securing the introduction device to an epicardial surface of the heart wall before the advancing step; securing individual clips of the tethered clip assembly at circumferentially spaced-apart locations about at least a portion of the annulus; cinching the tether through the clips to circumferentially tighten the annulus; and preventing the terminal clip from moving proximally past a chosen location along the tether after the cinching step.

Claim 34

Dependent Claim 42 words

A method as in claim 30 , wherein the instrument introduction device comprises at least one of a valve, a diaphragm and a haemostatic barrier for allowing passage of at least the clip applicator while preventing outflow of blood from the heart.

Claim 35

Independent Claim 200 words

A method for constricting a heart valve annulus, the method comprising: introducing a tethered clip assembly to the annulus, the tethered clip assembly comprising a plurality of clips coupled with a tether, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether; securing individual clips of the tethered clip assembly at circumferentially spaced-apart locations about at least a portion of the annulus; stabilizing the annulus prior to introducing the clips: wherein stabilizing comprises: introducing a first stabilizing ring beneath the valve leaflets, wherein the ring engages the intersection between the leaflets and the interior ventricular wall; and introducing a second stabilizing ring over the annulus, wherein the first and second stabilizing rings clamp and immobilize the annulus prior to the securing step; cinching the tether through the clips to circumferentially tighten the annulus; and preventing the terminal clip from moving proximally pst a chosen location along the tether after the cinching step.

Claim 36

Independent Claim 200 words

A method for constricting a heart valve annulus, the method comprising: introducing a tethered clip assembly to the annulus, the tethered clip assembly comprising a plurality of clips coupled with a tether, the plurality of clips comprising a first clip, an intermediate clip, and a terminal clip, wherein the first clip and a lead end of the tether are constructed to prevent the first clip from moving distally past the lead end of the tether, and wherein one or more of the remaining clips are slidably coupled to the tether; securing individual clips of the tethered clip assembly at circumferentially spaced-apart locations about at least a portion of the annulus; stabilizing the annulus prior to introducing the clips: wherein stabilizing comprises: introducing a first stabilizing ring beneath the valve leaflets, wherein the ring engages the intersection between the leaflets and the interior ventricular wall; and introducing a second stabilizing ring over the annulus, wherein the first and second stabilizing rings clamp and immobilize the annulus prior to the securing step; cinching the tether through the clips to circumferentially tighten the annulus; and preventing the terminal clip from moving proximally pst a chosen location along the tether after the cinching step.

Claim 37

Dependent Claim 20 words

A method as in claim 32 , wherein the securing step comprises delivering the clips from one of said rings.

Claim 38

Independent Claim 102 words

A method for constricting a heart valve annulus in a beating heart, said method comprising; stabilizing the annulus; securing individual clips at circumferentially spaced-apart locations about at least a portion of the annulus while said remains stabilized; the stabilizing step comprising: introducing a first stabilizing ring beneath the valve leaflets, wherein the ring engages the intersection between the leaflets and the interior ventricular wall; and introducing a second stabilizing over the valve leaflets, wherein the first and second stabilizing rings clamp and immobilize the annulus prior to securing the clips; and cinching a tether through the clips to circumferentially tighten the annulus.

Claim 39

Independent Claim 102 words

A method for constricting a heart valve annulus in a beating heart, said method comprising; stabilizing the annulus; securing individual clips at circumferentially spaced-apart locations about at least a portion of the annulus while said remains stabilized; the stabilizing step comprising: introducing a first stabilizing ring beneath the valve leaflets, wherein the ring engages the intersection between the leaflets and the interior ventricular wall; and introducing a second stabilizing over the valve leaflets, wherein the first and second stabilizing rings clamp and immobilize the annulus prior to securing the clips; and cinching a tether through the clips to circumferentially tighten the annulus.

Claim 40

Dependent Claim 20 words

A method as in claim 34 , wherein securing said clips comprises delivering the clips from one of said rings.

Claim 41

Dependent Claim 34 words

A method as in claim 34 , wherein securing said clips comprises deploying clips successively from an applicator which is advanced around a path defined by the stabilizing ring while said annulus remains stabilized.

Annuity Stage	Window Opens	Payment Deadline	Surcharge Period Until	Estimated Fee	Status
3.5 Years (Year 4)	2009-01-16	2009-07-18	2010-01-17	$2000.00	Window Closed / Lapsed
7.5 Years (Year 8)	2013-01-16	2013-07-18	2014-01-17	$3760.00	Window Closed / Lapsed
11.5 Years (Year 12)	2017-01-16	2017-07-18	2018-01-17	$7700.00	Window Closed / Lapsed

Devices and methods for heart valve repair

Abstract

Inventors

Bibliographic Details

Claims Analysis

References Cited (Backward Citations)

USPTO Annuity & Maintenance Windows

Assigned Categories & Tags

Assign Category Tag