Source: http://www.google.com/patents/US8147542?dq=5,890,152
Timestamp: 2014-12-28 13:38:00
Document Index: 219162063

Matched Legal Cases: ['art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2', 'art 2']

Patent US8147542 - Adjustable repair chords and spool mechanism therefor - Google PatentsSearch Images Maps Play YouTube News Gmail Drive More »Sign inAdvanced Patent SearchPatentsA method and device is provided, including implanting, at an intraventricular site of a ventricle of a patient, a spool coupled to a first end portion of a longitudinal member, and coupling a second end portion of the longitudinal member to a portion of tissue facing a lumen of the ventricle. Other embodiments...http://www.google.com/patents/US8147542?utm_source=gb-gplus-sharePatent US8147542 - Adjustable repair chords and spool mechanism thereforAdvanced Patent SearchPublication numberUS8147542 B2Publication typeGrantApplication numberUS 12/435,291Publication dateApr 3, 2012Filing dateMay 4, 2009Priority dateDec 22, 2008Also published asUS20100161041, US20140094903Publication number12435291, 435291, US 8147542 B2, US 8147542B2, US-B2-8147542, US8147542 B2, US8147542B2InventorsFrancesco Maisano, Eran Miller, Oz Cabiri, Yaron HermanOriginal AssigneeValtech Cardio, Ltd.Export CitationBiBTeX, EndNote, RefManPatent Citations (103), Non-Patent Citations (12), Referenced by (3), Classifications (17), Legal Events (1) External Links: USPTO, USPTO Assignment, EspacenetAdjustable repair chords and spool mechanism thereforUS 8147542 B2Abstract A method and device is provided, including implanting, at an intraventricular site of a ventricle of a patient, a spool coupled to a first end portion of a longitudinal member, and coupling a second end portion of the longitudinal member to a portion of tissue facing a lumen of the ventricle. Other embodiments are also described.
The invention claimed is: 1. Apparatus, comprising:
a delivery tool comprising:
a shaft (a) being slidable with respect to the handle portion, and (b) having a proximal portion thereof being slidable into the handle lumen during proximal sliding of the shaft;
a spool reversibly couplable to a distal end of the delivery tool and configured to be positioned in an intraventricular site of a ventricle of a patient, wherein:
the spool has a first end shaped to define a first opening, and a second end shaped to define a second opening, the spool being shaped to define a channel extending from the first opening to the second opening, the channel being configured for passage therethrough of an elongate rotation tool, and
the second end of the spool has a lower surface thereof shaped to define one or more recesses at locations along a circumference; and
at least one longitudinal member having opposite first and second end portions, the first end portion being coupled to the spool and the second end portion configured to be coupled to a first portion of heart tissue that surrounds a ventricular space of the ventricle of the patient, the longitudinal member:
configured to be wound around the spool in response to rotation of the spool in a first direction thereof, and, responsively, to draw the second end portion of the longitudinal member and the first portion of heart tissue toward the first end portion of the longitudinal member.
2. The apparatus according to claim 1, wherein the shaft is shaped to provide at least one shaft lumen configured for housing a section of the longitudinal member that is between the first and second end portions thereof.
3. The apparatus according to claim 1, wherein the longitudinal member comprises expanded polytetrafluoroethylene (ePTFE).
4. The apparatus according to claim 1, wherein at least a portion of the longitudinal member is shaped to define a coil, and wherein the coil is configured to apply a tensioning force to the first portion of heart tissue.
5. The apparatus according to claim 1, wherein the longitudinal member is coated with polytetrafluoroethylene.
6. The apparatus according to claim 1, further comprising a locking mechanism coupled to the spool and configured to restrict rotation of the spool.
7. The apparatus according to claim 1, further comprising at least one guide wire coupled to the spool, and wherein, subsequently to the positioning of the spool, the delivery tool is configured to be:
8. The apparatus according to claim 7, wherein the spool is configured to be implanted at the intraventricular site, and wherein the guide wire is configured to facilitate access of a torque-delivering-tool to the spool following the implantation of the spool at the intraventricular site.
9. The apparatus according to claim 1, further comprising a torque-delivering-tool, wherein:
the shaft is shaped to define at least a primary shaft lumen,
the torque-delivering-tool is coupled at a proximal end thereof to the handle portion and is disposed in the primary shaft lumen, and
the shaft is slidable with respect to the torque-delivering-tool.
10. The apparatus according to claim 9, wherein the delivery tool is configured to be advanceable between leaflets of an atrioventricular valve of the patient, and wherein the shaft is slidable with respect to the torque-delivering-tool in a manner that reduces a diameter of a portion of the delivery tool that is disposed between the leaflets of the valve.
11. The apparatus according to claim 9, wherein the handle lumen has a handle-lumen-length of between 50 mm and 100 mm, and wherein the shaft is slidable in a proximal direction to advance the proximal portion thereof into the handle lumen.
12. The apparatus according to claim 11, wherein a distal portion of the torque-delivering-tool is configured to be positioned within the ventricular space of the heart and defines a torque-delivering-tool-length at the distal portion of between 50 mm and 100 mm, and wherein a ratio of the handle-lumen-length and the torque-delivering-tool-length at the distal portion is between 0.7:1 and 1.3:1.
the at least one longitudinal member comprises at least first and second longitudinal member portions having respective first and second end portions thereof,
the first end portions of the first and second longitudinal member portions are coupled to the spool,
the second end portion of the first longitudinal member portion is configured to be coupled to the first leaflet of the valve,
the second end portion of the second longitudinal member portion is configured to be coupled to the second leaflet of the valve, and
in response to rotation of the spool, the first and second longitudinal member portions are tightened and pull on the respective second end portions thereof toward the spool.
14. The apparatus according to claim 13, wherein in response to rotation of the spool in the first direction, the respective first end portions of the first and second longitudinal member portions are configured to be wound around the spool, and, responsively, to pull the respective second end portions of the first and second longitudinal member portions toward the spool, and responsively to draw the first and second leaflets toward each other.
15. The apparatus according to claim 1, further comprising a mechanical element having a surface coupled to the lower surface of the spool, the mechanical element being shaped to provide:
a protrusion protruding out of a plane of the surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the spool, and
a depressible portion coupled to the protrusion, the depressible portion being disposed in communication with the second opening of the lower surface, and configured to dislodge the protrusion from within the recess in response to a force applied thereto by the elongate rotation tool.
16. The apparatus according to claim 15, further comprising a housing surrounding the spool, the housing being coupled in part to a cap having a surface that is disposed in parallel with the lower surface of the spool, and wherein the depressible portion is disposed between the lower surface of the spool and the cap.
17. The apparatus according to claim 15, further comprising a housing surrounding the spool, the housing being shaped to define a recessed portion thereof configured to receive the protrusion during the resting state of the mechanical element.
18. The apparatus according to claim 15, further comprising a torque-delivering-tool disposed within a primary lumen of the shaft, wherein the torque-delivering tool is coupled at a distal end thereof to the elongate rotation tool, and wherein the torque-delivering-tool is configured to facilitate rotation of the spool by facilitating rotation of the elongate rotation tool.
the torque-delivering-tool is configured to maintain the protrusion in a position in which it is dislodged from the recess, and
the torque-delivering-tool is configured to rotate the spool, and during a second period:
the torque-delivering-tool is configured to remove the elongate rotation tool from the channel and thereby to position the protrusion in the recess, and
in response to the positioning, the spool is restricted from being rotated.
20. The apparatus according to claim 1, wherein:
the at least one longitudinal member comprises at least first and second longitudinal members having respective first and second end portions thereof,
in response to rotation of the spool, the first and second longitudinal members are tightened and pull the first and second portions of tissue of the inner wall toward one other.
21. The apparatus according to claim 1, further comprising an elongate tube coupled at a first end to the spool and configured, at a second end thereof, to be coupled to subcutaneous tissue of the patient, wherein the elongate tube is configured to facilitate accessing of a torque-delivering-tool to the spool following (a) the positioning of the spool at the intraventricular site and (b) subsequent removal of the delivery tool.
22. The apparatus according to claim 1, wherein:
the intraventricular site comprises a second portion of heart tissue that surrounds the ventricular space,
the spool is configured to be coupled to the second portion of heart tissue that surrounds the ventricular space, and
in response to the rotation of the spool, the longitudinal member is configured to draw the first and second portions of heart tissue toward each other.
24. The apparatus according to claim 23, wherein:
the second portion of heart tissue includes a papillary muscle of the ventricle,
the spool is configured to be coupled to the papillary muscle, and
in response to the rotation of the spool, the longitudinal member is configured to draw the first portion of the inner wall of the ventricle toward the papillary muscle.
25. The apparatus according to claim 23, wherein:
the second portion of heart tissue includes a second portion of the inner wall of the ventricle,
the spool is configured to be coupled to the second portion of the inner wall of the ventricle, and
in response to the rotation of the spool, the longitudinal member is configured to draw the first and second portions of the inner wall of the ventricle toward one other.
26. The apparatus according to claim 22, wherein:
the first portion of heart tissue includes a leaflet of an atrioventricular valve of the patient,
the second end portion of the longitudinal member is configured to be coupled to the leaflet of the atrioventricular valve of the patient,
the second portion of heart tissue includes tissue of a papillary muscle of the ventricle,
the spool is configured to be implanted in the tissue of the papillary muscle of the ventricle, and
the spool is configured to adjust a length of the longitudinal member between the papillary muscle and the leaflet of the atrioventricular valve.
27. The apparatus according to claim 22, wherein:
the second portion of heart tissue includes a second portion of an inner wall of the ventricle,
the spool is configured to adjust a length of the longitudinal member between the second portion of the inner wall and the leaflet of the atrioventricular valve.
CROSS-REFERENCES TO RELATED APPLICATIONS The present application is related to a U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled, �Adjustable annuloplasty ring and spool mechanism therefor,� filed Dec. 22, 2008, which is incorporated herein by reference.
FIELD OF THE INVENTION The present invention relates in general to valve and chordae tendineae repair. More specifically, the present invention relates to repair of an atrioventricular valve and associated chordae tendineae of a patient.
BACKGROUND OF THE INVENTION Ischemic heart disease causes mitral regurgitation by the combination of ischemic dysfunction of the papillary muscles, and the dilatation of the left ventricle that is present in ischemic heart disease, with the subsequent displacement of the papillary muscles and the dilatation of the mitral valve annulus.
US Patent Application Publication 2007/0118151 to Davidson describes a method and system to achieve leaflet coaptation in a cardiac valve percutaneously by creation of neochordae to prolapsing valve segments. This technique is especially useful in cases of ruptured chordae, but may be utilized in any segment of prolapsing leaflet. The technique described herein has the additional advantage of being adjustable in the beating heart. This allows tailoring of leaflet coaptation height under various loading conditions using image-guidance, such as echocardiography. This offers an additional distinct advantage over conventional open-surgery placement of artificial chordae. In traditional open surgical valve repair, chord length must be estimated in the arrested heart and may or may not be correct once the patient is weaned from cardiopulmonary bypass. The technique described below also allows for placement of multiple artificial chordae, as dictated by the patient's pathophysiology.
The following patents and patent application publications, relevant portions of which are incorporated herein by reference, may be of interest:
PCT Patent Application Publication WO 07/136783 to Cartledge et al. U.S. Pat. No. 5,306,296 to Wright et al. U.S. Pat. No. 6,569,198 to Wilson et al. U.S. Pat. No. 6,619,291 to Hlavka et al. U.S. Pat. No. 6,764,510 to Vidlund et al. U.S. Pat. No. 7,004,176 to Lau U.S. Pat. No. 7,101,395 to Tremulis et al. U.S. Pat. No. 7,175,660 to Cartledge et al. US Patent Application Publication 2003/0050693 to Quijano et al US Patent Application Publication 2003/0167062 to Gambale et al. US Patent Application Publication 2004/0024451 to Johnson et al. US Patent Application Publication 2004/0148021 to Cartledge et al. US Patent Application Publication 2004/0236419 to Milo US Patent Application Publication 2005/0171601 to Cosgrove et al. US Patent Application Publication 2005/0288781 to Moaddeb et al. US Patent Application Publication 2007/0016287 to Cartledge et al. US Patent Application Publication 2007/0080188 to Spence et al. The following articles, which are incorporated herein by reference, may be of interest:
O'Reilly S et al., �Heart valve surgery pushes the envelope,� Medtech Insight 8(3): 73, 99-108 (2006) Dieter R S, �Percutaneous valve repair: Update on mitral regurgitation and endovascular approaches to the mitral valve,� Applications in Imaging, Cardiac Interventions, Supported by an educational grant from Amersham Health pp. 11-14 (2003) SUMMARY OF THE INVENTION In some embodiments of the present invention, subvalvular apparatus is provided comprising adjustable repair chords and a delivery tool for implantation thereof. The repair chords comprise one or more longitudinal members, e.g., sutures, wires, or elongate tensioning coils, which are coupled at respective first end portions thereof to an adjusting mechanism. In some embodiments, the repair chords function as artificial chordae tendineae. For some application, the repair chords are used to adjust a distance between two portions of the ventricular wall. The adjusting mechanism comprises a spool assembly which comprises a housing which houses a spool to which the first end portion of the longitudinal member is coupled. Typically, the longitudinal member is coupled to, e.g., knotted to or looped through, the spool such that the longitudinal member defines a first end portion thereof that is coupled to the spool and at least one free end of the longitudinal member. The housing of the adjusting mechanism is coupled to a tissue anchor which facilitates implantation of the adjusting mechanism in a first portion of tissue of the heart which faces and surrounds the ventriclular lumen, e.g., a papillary muscle or a first portion of a ventricular wall of the heart. Following implantation of the adjusting mechanism at the implantation site, the operating physician couples (e.g., ties, sutures, clips, or otherwise fastens) the free end of the longitudinal member to a second portion of tissue which faces and surrounds the ventricle, e.g., a leaflet of an atrioventricular valve or a second portion of the ventricular wall.
Once the free end of the longitudinal member is coupled to the second portion of tissue of the heart that faces and surrounds the ventricle, the operating physician rotates the spool in order to adjust a length of the longitudinal member. During the rotation of the spool in a first direction thereof, the longitudinal member is wound around the spool thereby shortening and tensioning the longitudinal member. Responsively, the ends of the longitudinal member coupled to the second portion of heart tissue, and consequently the second portion of tissue, are pulled toward the adjusting mechanism at the implantation site. Thus, for embodiments in which the repair chord functions as an artificial chordae tendineae, the longitudinal member replaces slackened native chordae tendineae and restores normal function to the atrioventricular valve.
The adjusting mechanism comprises a reversible locking mechanism which facilitates bidirectional rotation of the spool in order to effect both tensioning and relaxing of the longitudinal member. That is, the spool is wound in one direction in order to tighten the longitudinal member, and in an opposite direction in order to slacken the longitudinal member. Thus, the spool adjusting mechanism facilitates bidirectional adjustment of the repair chord.
The delivery tool comprises a handle and a multilumen shaft that is coupled at a distal end thereof to the adjusting mechanism. The delivery tool functions to advance the adjusting mechanism to the implantation site, implant the adjusting mechanism at the implantation site, and effect adjustment of the repair chord by effecting rotation of the spool. The multilumen shaft defines a primary lumen which houses an elongate torque-delivering tool and is slidable with respect to a shaft of the elongate torque-delivering tool. For embodiments in which the repair chord functions as artificial chordae tendineae, prior to implantation of the adjusting mechanism, the distal portion of the delivery tool and the adjusting mechanism coupled thereto are advanced between the leaflets of the atrioventricular valve and into the ventricle toward the implantation site. During the implantation of the adjusting mechanism, the multilumen shaft is disposed around the portion of the torque-delivering tool that is positioned in the ventricle. Prior to the subsequent rotation of the spool, the multilumen shaft is pulled proximally with respect to the torque-delivering tool that is left in place during the pulling. The multilumen shaft is pulled such that a distal end thereof is disposed proximal to the valve and in the atrium.
The incision made in the heart is then closed around the delivery tool and the heart resumes its normal function during the adjustment of the length of the artificial chordae. The retracting of the multilumen shaft reduces a diameter of the delivery tool at the portion thereof that is disposed between the leaflets of the valve. Such reducing of the diameter reduces the interference of the portion of the delivery tool on the beating heart valve and the adjustment of the artificial chordae is performed with minimal interference to the valve by the delivery tool.
In some embodiments, apparatus and method described herein may be used for providing artificial chordae tendineae in a left ventricle of the heart and effecting adjustment thereof. In some embodiments, apparatus and method described herein may be used for providing artificial chordae tendineae in a right ventricle of the heart and effecting adjustment thereof. In some embodiments, apparatus and method described herein may be used for providing a system to adjust a length between two portions of the heart wall.
implanting, at an intraventricular site of a ventricle of a patient, a spool coupled to a first end portion of a longitudinal member; and
In an embodiment, the method includes transcatheterally advancing the spool toward the intraventricular site.
In an embodiment, the method includes advancing the spool toward the intraventricular site during an open-heart procedure.
In an embodiment, the method includes advancing the spool toward the intraventricular site during a minimally-invasive procedure.
In an embodiment, coupling the second end portion of the longitudinal member to the portion of tissue facing the ventricular lumen includes coupling the second end portion of the longitudinal member to a leaflet of an atrioventricular valve of the patient.
In an embodiment, the spool is coupled to a tissue anchor, and implanting the spool in the intraventricular site includes implanting the tissue anchor in tissue of the ventricle in a manner in which a distal end of the tissue anchor is disposed within the tissue of the ventricle and does not extend beyond a pericardium of a heart of the patient.
implanting the spool includes implanting the spool at a first portion of tissue facing the ventricular lumen,
rotating the spool in a first direction thereof, by the rotating of the spool, winding a portion of the longitudinal member around the spool, by the winding of the portion, shortening a length of the longitudinal member, and by the shortening of the length of the longitudinal member, drawing together the first and second portions of the tissue facing the ventricular lumen of the patient. In an embodiment:
implanting the spool at the first portion of tissue includes implanting the spool at a papillary muscle of a left ventricle of the patient,
implanting the spool at the first portion of tissue includes implanting the spool at a papillary muscle of a right ventricle of the patient,
implanting the spool at the first portion of tissue includes implanting the spool at a first portion of tissue of an inner wall of a left ventricle of the patient,
implanting the spool at the first portion of tissue includes implanting the spool at a first portion of an inner wall of a right ventricle of the patient,
implanting the spool at the first portion of tissue includes implanting the spool at a first portion of an inner wall of the ventricle of the patient,
drawing together the first and second portions of the tissue facing the ventricular lumen includes drawing the first and second portions of tissue of the inner wall of the ventricle toward each other.
implanting the spool at the first portion of tissue includes implanting the spool at a papillary of the ventricle of the patient,
drawing together the first and second portions of the tissue facing the ventricular lumen includes drawing the papillary muscle and the portion of tissue of the inner wall of the ventricle toward each other.
In an embodiment, implanting the spool coupled to the first end portion of the longitudinal member includes implanting a spool coupled to at least first and second longitudinal members at respective first end portions thereof, each longitudinal member having respective second end portions thereof, and the method further includes:
coupling the second end portion of the first longitudinal member to a first portion of heart tissue facing the ventricular lumen,
coupling the second end portion of the second longitudinal member to a second portion of heart tissue facing the ventricular lumen, and
drawing the first and second portions of heart tissue toward each other.
In an embodiment, implanting the spool includes implanting the spool at a papillary muscle.
In an embodiment, implanting the spool includes implanting the spool at a portion of tissue of an inner wall of the ventricle facing the ventricular lumen.
coupling the second end portion of the first longitudinal member to the first portion of tissue includes coupling the second end portion of the first longitudinal member to a first portion of an inner wall of the ventricle,
drawing the first and second portions of heart tissue toward each other includes drawing together the first and second portions of the inner wall of the ventricle.
drawing the first and second portions of heart tissue toward each other includes drawing the portion of the inner wall of the ventricle and the papillary muscle toward each other.
drawing the first and second portions of heart tissue toward each other includes drawing the leaflet and the papillary muscle toward each other.
drawing the first and second portions of heart tissue toward each other includes drawing the leaflet and the portion of the inner wall toward each other.
drawing the first and second portions of heart tissue toward each other includes drawing the first and second leaflets toward each other.
In an embodiment, the method includes advancing the spool toward the intraventricular site by advancing a portion of a delivery tool that is reversibly coupled to the spool between leaflets of an atrioventricular valve having at least first and second leaflets thereof, and implanting the spool at the intraventricular site includes manipulating the delivery tool to implant the spool at the intraventricular site.
following the implanting of the spool:
decoupling the delivery tool from the spool, removing the delivery tool from the ventricle, and subsequently to the removing, accessing the spool at the intraventricular site. In an embodiment, accessing the spool includes recoupling the delivery tool to the spool by advancing the delivery tool along at least one guide wire coupled to the spool.
In an embodiment, accessing the spool comprises coupling a torque-delivering-tool to the spool by advancing the torque-delivering-tool through an elongate tube coupled at a first end thereof to the spool and at second end thereof to a portion of subcutaneous tissue of the patient.
following the coupling of the second end portion of the longitudinal member to the portion of tissue facing the ventricular lumen:
sliding a shaft of the delivery tool with respect to a torque-delivering tool of the delivery tool, and sliding a proximal portion of the shaft into a lumen of a handle portion of the delivery tool; and subsequently to the sliding, rotating the spool in the first direction thereof. In an embodiment, sliding the shaft includes:
implanting the spool includes implanting:
a spool coupled to a mechanical locking element having a surface coupled to the lower surface of the rotatable structure, and the method further includes:
advancing an elongate tool through a channel provided by the spool; unlocking the spool from the mechanical locking element by pushing a depressible portion of the surface of the locking element; responsively to the pushing of the depressible portion, dislodging a protrusion protruding out of a plane of the surface of the mechanical element from within a recess defined by the spool; and rotating the spool. In an embodiment:
in response to the pushing of the elongate tool, maintaining the protrusion in a position in which it is dislodged from the recess, and rotating the spool; during a second period:
removing the elongate tool from within the channel and facilitating positioning of the protrusion in the recess, and restricting rotation of the spool. There is further provided, in accordance with an embodiment of the present invention, apparatus, including:
a handle portion defining a handle lumen; and a shaft (a) being slidable with respect to the handle, and (b) having a proximal portion thereof being slidable into the handle lumen during proximal sliding of the shaft; a spool reversibly couplable to the distal end of the delivery tool and configured to be implanted in an intraventricular site of a ventricle of a patient; and
a longitudinal member having opposite first and second end portions thereof, the first portion being coupled to the spool and the second end portion configured to be coupled to a first portion of heart tissue that surrounds a ventricular space of the ventricle of the patient, the longitudinal member:
in response to rotation of the spool in a first direction thereof, configured to be wound around the spool, and, responsively, to draw the second end portion of the longitudinal member and the first portion of heart tissue toward the first end portion of the longitudinal member. In an embodiment, the shaft is shaped to provide at least one secondary lumen configured for housing a section of the longitudinal member that is between the first and second end portions thereof.
In an embodiment, the longitudinal member is coated with polytetrafiuoroethylene.
In an embodiment, the apparatus includes, a locking mechanism coupled to the implant structure and configured to restrict rotation of the spool.
the apparatus includes include at least first and second longitudinal members having respective first and second end portions thereof,
the first end portions of the first and second longitudinal members are coupled to the spool, the second end portion of the first longitudinal member is configured to be coupled to a leaflet of an atrioventricular valve, the second end portion of the second longitudinal member is configured to be coupled to a portion of tissue of an inner wall of the ventricle, and in response to rotation of the spool, the first and second longitudinal members are tightened and pull the leaflet toward the portion of tissue of the inner wall. In an embodiment:
the second end portion of the first longitudinal member is configured to be coupled to the leaflet of the valve,
in response to rotation of the spool, the first and second longitudinal members are tightened and pull the leaflet toward the papillary muscle.
in response to rotation of the spool, the first and second longitudinal members are tightened and pull the first and second portions of tissue of the inner wall toward each other.
In an embodiment, the apparatus includes an elongate tube coupled at a first end to the spool and at a second end thereof to subcutaneous tissue of the patient, the elongate tube is configured to facilitate accessing of a torque-delivering-tool to the spool following (a) the implantation of the spool at the intraventricular site and (b) subsequent removal of the delivery tool.
In an embodiment, the spool is configured to be coupled to a second portion of heart tissue that surrounds the ventricular space, and, in response to the rotation of the spool, the longitudinal member is configured to draw the first and second portions of heart tissue toward each other.
in response to the rotation of the spool, the longitudinal member is configured to draw the first and second portions of the inner wall of the ventricle toward each other.
the second end portion of the longitudinal member is configured to be coupled to the leaflet of the mitral valve of the patient,
the second portion of heart tissue includes tissue of a papillary muscle of a left ventricle,
the second portion of heart tissue includes a second portion of an inner wall of a right ventricle,
In an embodiment, the guide wire is configured to facilitate access of a torque-delivering-tool to the spool following the implantation of the spool at the intraventricular site.
In an embodiment, the apparatus includes a torque-delivering-tool, and:
the torque-delivering-tool is disposed in the primary lumen and is coupled at a proximal end thereof to the handle, and
In an embodiment, the delivery tool is configured to be advanceable between leaflets of an atrioventricular valve of the patient, and the shaft is slidable with respect to the torque-delivering-tool in a manner that reduces a diameter of a portion of the delivery tool that is disposed between the leaflets of the valve.
In an embodiment, the distal portion of the torque-delivering tool is configured to be positioned within the ventricular space of the heart and defines a torque-delivering-tool-length at the distal portion of between 50 mm and 100 mm, and a ratio of the handle-lumen-length and the torque-delivering-tool-length at the distal portion is between 0.7:1 and 1.3:1.
In an embodiment, in response to rotation of the spool in a first direction thereof, the respective first end portions of the first and second longitudinal members are configured to be wound around the spool, and, responsively, to pull the respective second end portions of the first and second longitudinal members toward the spool, and responsively to draw the first and second leaflets toward each other.
the second end of the spool has a lower surface thereof shaped to:
provide at least a portion thereof having a circumference, and define one or more recesses at locations along the circumference. In an embodiment, the apparatus includes a mechanical element having a surface coupled to the lower surface of the spool, the mechanical element being shaped to provide:
a protrusion protruding out of a plane of the surface of the mechanical element, the protrusion being disposed within one of the recesses during a resting state of the mechanical element, in a manner that restricts rotation of the spool, and a depressible portion coupled to the protrusion, the depressible portion being disposed in communication with the second opening of the lower surface, and configured to dislodge the protrusion from within the recess in response to a force applied thereto by the elongate tool. In an embodiment, the apparatus includes a housing surrounding the spool, the housing being coupled in part to a cap having a surface that is disposed in parallel with the lower surface of the spool, and the depressible portion is disposed between the lower surface of the rotatable structure and the cap.
In an embodiment, the apparatus includes a torque-delivering-tool disposed within a primary lumen of the shaft, the torque-delivering tool is coupled at a distal end thereof to the elongate rotation tool, and the torque-delivering tool is configured to facilitate rotation of the spool by facilitating rotation of the elongate tool.
the torque-delivering-tool is configured to maintain the protrusion in a position in which it is dislodged from the recess, and the torque-delivering-tool is configured to rotate the spool, and during a second period: the torque-delivering-tool is configured to remove the elongate tool from the channel and to position the protrusion in the recess, and
There is additionally provided, in accordance with an embodiment of the present invention, apparatus, including:
provide at least a portion thereof having a circumference, and define one or more recesses at locations along the circumference; and a mechanical element having a surface coupled to the lower surface of the rotatable structure, the mechanical element being shaped to provide:
the elongate tool is configured to maintain the protrusion in a position in which it is dislodged from the recess, and the elongate tool is configured to rotate the rotatable structure, and during a second period: the elongate tool is configured to remove the elongate tool from the channel and to position the protrusion in the recess, and the rotatable structure is restricted from being rotated. In an embodiment, the apparatus includes a housing surrounding the rotatable structure, the housing being coupled in part to a cap having a surface that is disposed in parallel with the lower surface of the rotatable structure, and the depressible portion is disposed between the lower surface of the rotatable structure and the cap.
In an embodiment
the elongate tool is configured to maintain the protrusion in a position in which it is dislodged from the recess, and the elongate tool is configured to rotate the spool, and during a second period: the elongate tool is configured to remove the elongate tool from the channel and to position the protrusion in the recess, and the spool is restricted from being rotated. In an embodiment:
the spool is configured for implantation in a first portion of heart tissue that defines a ventricular lumen of the ventricle of a patient,
There is yet additionally provided, in accordance with an embodiment of the present invention, a method, including:
in response to the pushing of the elongate tool, maintaining the protrusion in a position in which it is dislodged from the recess; and rotating the rotating structure; and during a second period:
removing the elongate tool from within the channel and facilitating positioning of the protrusion in the recess; and restricting rotation of the rotatable structure. There is still further provided, in accordance with an embodiment of the present invention, an implant delivery tool, including:
an elongate delivery tool shaft coupled at a proximal end thereof to the handle portion and at a distal end thereof to the implant-coupling portion; and
a needle holder coupled along a portion of the shaft between the implant-coupling portion and the handle, the needle holder being shaped to define at least one slit for receiving a needle.
In an embodiment, the apparatus includes an implant structure including at least one longitudinal member coupled at a free end thereof to a needle.
In an embodiment, the longitudinal member extends along the shaft toward the needle holder, and the needle holder is shaped to provide a projection thereof configured for winding excess portions of the longitudinal member therearound.
In an embodiment, the handle portion is shaped to define a handle lumen, and a proximal portion of the shaft is configured for slidable advancement within the handle lumen of the handle portion.
There is also provided, in accordance with an embodiment of the present invention apparatus, including:
There is additionally provided, in accordance with an embodiment of the present invention, a method, including:
implanting an adjusting assembly configured in an intraventricular site of a ventricle of a patient;
BRIEF DESCRIPTION OF THE DRAWINGS FIG. 1 is a schematic illustration of respective portions of a delivery tool system for implanting and adjusting repair chords, in accordance with an embodiment of the present invention;
FIGS. 9, 10A-B, and 11 are schematic illustrations of the repair chords used to draw portions of a ventricular wall toward each other, in accordance with an embodiment of the present invention; and
FIGS. 12A-B are schematic illustrations of the repair chords used to draw together leaflets of an atrioventricular valve, in accordance with an embodiment of the present invention.
DETAILED DESCRIPTION OF EMBODIMENTS Reference is now made to FIGS. 1-2, which are schematic illustrations of a system 10 comprising apparatus for implanting and adjusting repair chords in a heart of a patient, in accordance with an embodiment of the present invention. FIG. 1 is a schematic illustration of a portion of the respective components of system 10 showing the relationship between the components. System 10 comprises a delivery tool 20 having a proximal handle portion 24 and an elongate multilumen shaft 22. System 10 comprises an implant structure comprising a spool assembly 240 that is reversibly couplable to a distal portion of delivery tool 20. Spool assembly 240 comprises an adjusting mechanism 40 that is coupled to a tissue anchor 50. Tissue anchor 50 is shown as a helical anchor by way of illustration and not limitation, and may comprise staples, clips, spring-loaded anchors, or other tissue anchors known in the art. Alternatively, spool assembly 240 does not include tissue anchor 50 and is, instead, sutured to a portion of tissue of a ventricle wall which faces a ventricular lumen of a heart of a patient.
Shaft 22 comprises a multilumen shaft defining a primary lumen surrounding a torque-delivering-tool 26 which is surrounded by an overtube 90 (as shown in the transverse cross-section of tool 22 in FIG. 2). Torque-delivering-tool 26 is coupled at a proximal end thereof to a rotating structure 32 that is coupled to handle 24 and, in response to rotation thereof, functions to deliver torque to torque-delivering-tool 26. Torque-delivering-tool 26 rotates in response to rotation of rotating structure 32 and delivers torque to adjusting mechanism 40 coupled to the distal end of tool 20. (In this context, in the specification and in the claims, �proximal� means closer to the orifice through which tool 20 is originally placed into the body of the subject, and �distal� means further from this orifice.)
FIG. 2 shows delivery tool 20 in its assembled state comprising longitudinal members 60 and 62 which function as the repair chords that are ultimately implanted in the heart of the patient. Respective first end portions of longitudinal members 60 and 62 are coupled to a spool that is housed within a spool housing 42 of spool assembly 240. Thus, the implant structure comprises spool assembly 240 and longitudinal members 60 and 62. Each longitudinal member 60 and 62 has a free end that is coupled to a respective suture needle 64. The pointed tips of each needle 64 are disposed within a respective slit 72 of a needle holder 70. Each longitudinal member 60 and 62 extends from its first portions thereof, through a respective secondary lumen 192 of multilumen shaft 22 (as shown in the transverse cross-section of shaft 22) toward needle holder 70. Needle holder 70 is shaped to provide knobs 170 for looping portions of each longitudinal member 60 and 62 therearound. During delivery of spool assembly 240 to the implantation site in the ventricle of the patient, portions of longitudinal members 60 and 62 are wound around knobs 170 of needle holder 70 and needles 64 are disposed within slits 72 of needle holder 70 so as to facilitate a traumatic delivery of spool assembly 240 to the implantation site. During the implantation of longitudinal members 60 and 62 in the heart of the patient, needles 64 are extracted from slits 72, and longitudinal members 60 and 62 are unwound from knobs 170. Unwinding longitudinal members 60 and 62 extends longitudinal members 60 and 62 and provides the operating physician with enough slack to suture respective portions of longitudinal members 60 and 62 to heart tissue (e.g., a valve leaflet or a portion of the ventricle wall) that faces and surrounds the ventricular lumen of the heart.
A distal portion of delivery tool 20 comprises a screwdriver housing 28 which houses a screwdriver tool, as is described hereinbelow. Housing 28 is shaped to define graspers 30 which reversibly grasp housing 42 of adjusting mechanism 40 of spool assembly 240. Graspers 30 have a tendency to compress toward one another, and thus are clamped around housing 42. As shown in the enlarged distal portion of tool 22, longitudinal members 60 and 62 emerge from within housing 42. The spool disposed within housing 42 is not shown for clarity of illustration; however, it is to be noted that respective portions of longitudinal members 60 and 62 are coupled to the spool. One or more (e.g., a pair, as shown) of guide wires 160 and 162 are (1) coupled at respective first ends thereof to housing 42 and extend (2) through respective proximal openings 29 in screwdriver housing 28, (3) through respective secondary lumens 194 of multilumen shaft 22 (as shown in the transverse cross-section of shaft 22), and (4) are coupled at respective second ends thereof to handle portion 24.
Longitudinal members 60 and 62 extend externally to screwdriver housing 28 and through respective secondary lumens 192 of multilumen shaft 22. It is to be noted that although two longitudinal members 60 and 62 are shown as being coupled to spool 46, any suitable number of longitudinal members may be coupled to spool 46. In some embodiments, only one longitudinal member is coupled at a first end thereof to spool 46, and the second end of the longitudinal member is configured to be attached to heart tissue, e.g., a leaflet of an atrioventricular valve or a portion of the ventricular wall. For some applications, the one longitudinal member may be looped within spool 46 in a manner in which a middle portion thereof is looped within the spool and respective portions thereof extend from spool 46 along shaft 22 in their respective lumens 192. In such an embodiment, the one longitudinal member defines two free ends which are coupled to suture needles and are ultimately attached to, e.g., sutured to, heart tissue.
A distal end of shaft 22 is disposed proximally to a proximal end of screwdriver housing 28. As described hereinabove, torque-delivering-tool 26 and overtube 90 that surrounds torque-delivering-tool 26 are disposed within primary lumen 190 of shaft 22. Screwdriver housing 28 is shaped to define a primary lumen which receives a distal portion of torque-delivering-tool 26 and a distal portion of overtube 90. During delivery of spool assembly 240 to the implantation site in the ventricle, a distal end of overtube 90 is disposed within housing 28 proximally to a distal end of torque-delivering-tool 26. A distal portion of torque-delivering-tool 26 is disposed within a screwdriver head 95 that is disposed within housing 28. Screwdriver head 95 defined a recess for receiving the distal portion of torque-delivering-tool 26. Screwdriver head 95 is shaped to provide a spool-rotating portion 94 which fits within a channel defined by spool 46. Spool-rotating portion 94 is shaped in accordance with the shape of the channel defined by spool 46 such that rotation of torque-delivering-tool 26 delivers torque to and rotates screwdriver head 95. In response to the rotation of screwdriver head 95, spool-rotating portion 94 pushes against the wall of spool 46 that defines the channel extending therethrough, and responsively, spool 46 is rotated.
Reference is now made to FIGS. 2-3. As shown in FIG. 2, guide wires 160 and 162 extend from spool housing 42 and through openings 29 defined in screwdriver housing 28. Since guide wires 160 and 162 are disposed within lumens of multilumen shaft 22 that are orthogonal with respect to lumens 192 (which surround longitudinal members 60 and 62), guide wires 160 and 162 are not shown in FIG. 3. Similarly, the openings 29 of screwdriver housing 28 are not shown in FIG. 3. It is to be noted that screwdriver housing is shaped to define a respective secondary lumen which surrounds each guide wire 160 and 162 and extend from spool housing 42 toward each proximal opening 29 in screwdriver housing 28. These secondary lumens run in parallel with respect to the primary lumen defined by housing 28 that surrounds torque-delivering-tool 26 and overtube 90.
FIG. 4A shows a relationship between individual components of adjusting mechanism 40, in accordance with an embodiment of the present invention. Adjusting mechanism 40 is shown as comprising spool housing 42 which defines an upper surface 41 and a recessed portion 142. Spool 46 is configured to be disposed within housing 42 and defines an upper surface 150, a lower surface 152 and a cylindrical body portion disposed vertically between surfaces 150 and 152. Spool 46 is shaped to provide a driving interface, e.g., a channel 48, which extends from an opening provided by upper surface 150 to an opening provided by lower surface 152. Channel 48 of the driving interface is shaped to define a hexagonal channel or a channel having another shape. The cylindrical body portion of spool 46 is shaped to define holes 260 and 262 which function as respective coupling sites for coupling longitudinal members 60 and 62 to spool 46. In some embodiments, system 10 described herein comprises only one longitudinal member which is looped through spool 46 via holes 260 and 262.
A cap 44 is provided that is shaped to define a planar surface and an annular wall having an upper surface 244 thereof. Upper surface 244 of the annular wall is coupled to, e.g., welded to, a lower surface provided by spool housing 42. The annular wall of cap 44 is shaped to define a recessed portion 144 of cap 44 that is in alignment with recessed portion 142 of spool housing 42.
Reference is now made to FIGS. 4B-C which are schematic illustrations of adjusting mechanism 40 in respective locking states thereof, in accordance with an embodiment of the present invention. It is to be noted that longitudinal members 60 and 62 that are typically coupled to spool 46, are not shown for clarity of illustration. FIG. 4B shows adjusting mechanism 40 in an unlocked configuration in which protrusion 156 of locking mechanism 45 is disposed within recessed portion 144 of cap 44. FIG. 4C shows the locked state of spool 46 by the positioning of protrusion 156 within a recess 154 of spool 46.
Reference is now made to FIGS. 3 and 4B-C. FIG. 4B shows adjusting mechanism 40 in an unlocked state thereof, as shown in FIG. 3. During (1) the delivery of spool assembly 240 to the implantation site in a first portion of tissue defining the ventricular lumen of the patient, (2) the attachment of the longitudinal members to a second portion of heart tissue that faces surrounds the ventricular lumen of the patient, and (3) the subsequent rotation of spool 46 to adjust a length between the first and second portions of heart tissue, adjusting mechanism 40 is disposed in an unlocked state, as shown in FIGS. 3 and 4B. As shown in FIG. 4C, spool 46 is shaped to provide a first opening 180 at upper surface 150 thereof and a second opening 182 at a lower surface 152 thereof. Spool 46 defines a channel 48 that extends from first opening 180 toward second opening 182.
During the unlocked state of adjusting mechanism 40, depressible portion 128 is maintained in a pushed state by force applicator 93. In such a state, protrusion 156 of locking mechanism 45 is maintained in a pushed state toward the planar surface of cap 44. It is to be noted that the surface of cap 44 may also be curved, and not planar. As described hereinabove, cap 44 is shaped to provide a recessed portion 144 for receiving protrusion 156 in its pushed-down state. As depressible portion 128 is pushed downward, protrusion 156 is freed from within a recess 154 defined by structural barrier portions 155 of the lower portion of spool 46. Additionally, protrusion 156 is freed from within recessed portion 142 provided by spool housing 42. Responsively, adjusting mechanism 40 is unlocked, and spool 46 may be rotated by screwdriver head 95 in either clockwise or counter-clockwise directions in response to torque delivered to head 95 by torque-delivering-tool 26 coupled thereto. In response to the torque, spool-rotating portion 94 of screwdriver head 95 engages and pushes against the wall defining channel 48 in order to rotate spool 46.
Reference is now made to FIGS. 5A-G, which are schematic illustrations of a method for implantation of spool assembly 240 and longitudinal members 60 and 62 of system 10 in the heart of the patient, in accordance with an embodiment of the present invention. FIG. 5A shows an open heart procedure in which an operating physician positioning tool 20 in a heart 2 of a patient and implanting spool assembly 240 in tissue of a papillary muscle 4 of the left ventricle of heart 2. FIG. 5A shows the general relative perspective of tool 20 with respect to heart 2. It is to be noted that FIGS. 5A-G are not drawn to scale in order to illustrate clearly the function of tool 20 in heart 2.
FIG. 5B shows a distal portion of tool 20 disposed within the left ventricle of heart 2. The operating physician advances a distal portion 71 of tool 20 between leaflets 12 and 14 of a mitral valve 8. Tool 20 is disposed with respect to heart 2 in a manner in which needle holder 70 is disposed outside of heart 2. As shown in the enlarged portion of needle holder 70, needle 64 of longitudinal member 60 is disposed within slit 72 of needle holder 70. Additionally, longitudinal member 60 is looped around knobs 170 of needle holder 70 such that knobs 170 gather excess portions of longitudinal member 60. Longitudinal member 60 emerges from within slit 122 defined by multilumen shaft 22 at a proximal opening 61 of slit 122. Longitudinal member 62 is also shown as emerging from within its respective-slit in shaft 22. The needle coupled to longitudinal member 62 is also housed within a slit provided by needle holder 70 (needle not shown for clarity of illustration).
Delivery tool 20 is rotated in order to corkscrew helical anchor 50 spool assembly 240 into tissue of papillary muscle 4 at an intraventricular implantation site 5. Spool assembly 240 is coupled to cardiac tissue in a manner in which spool housing 42 and spool 46 are disposed within the ventricular lumen at the intraventricular implantation site. Tissue anchor 50 is corkscrewed into the cardiac tissue in a manner in which it is disposed fully within the heart tissue, e.g., papillary muscle, endocardium, or myocardium, and does not extend beyond a pericardium of the heart. Papillary muscle 4 includes a portion of cardiac tissue which faces and surrounds the left ventricular lumen of heart 2. In response to rotation of tool 20, spool assembly 240 is implanted at a first implantation site 5. In the enlarged view of the distal portion of tool 20 and spool assembly 240, longitudinal members 60 and 62 (coupled to spool 46) and guide wires 160 and 162 (coupled to housing 42) are shown as emerging from housing 42 and are fed within their secondary respective lumens of multilumen shaft 22.
Section B-B shows a transverse cross-section of delivery tool 22 at a distal portion of handle 24. Section B-B shows handle 24 which surrounds guide 27. Guide 27, in turn, surrounds a proximal end of multilumen shaft 22. Torque-delivering-tool 26 surrounded by overtube 90 are disposed within the primary lumen of shaft 22. As shown, guide members 160 and 162 are disposed within secondary lumens 194 of shaft 22. Secondary lumens 192 (which house longitudinal members 60 and 62 at the portion of tool between needle holder 70 and the distal end of shaft 22) are empty at handle 24 because longitudinal members 60 and 62 exit lumens 192 distally to needle holder 70.
As shown in Section A-A, handle 24 comprises a torque facilitator (e.g., a spring) 132 that is coupled to and surrounds a proximal portion of torque-delivering-tool 26. Torque-delivering-tool 26 extends proximally within handle 24 to rotating structure 32 at the proximal end of handle 24.
FIG. 5D shows longitudinal members 60 and 62 coupled to leaflet 12 at second implantation site 7. Longitudinal members 60 and 62 are knotted together using suture knots 67, and excess portions of longitudinal members 60 and 62 are cut away from knot 67. It is to be noted that although knot 67 is used to couple longitudinal members 60 and 62 to leaflet 12, any suitable anchor may be used. For example, longitudinal member 60 may comprise a male clip at its free end and longitudinal member 62 may comprise a female clip at its free end. In such an embodiment, longitudinal members 60 and 62 are clipped at their free ends to leaflet 12.
Following the coupling of longitudinal members 60 and 62 to leaflet 12, shaft 22 is slid proximally to expose a portion of overtube 90 and torque-delivering-tool 26. During the proximal sliding of shaft 22, proximal portion 241 of shaft 22 is slid within lumen 23 of handle 24. Handle-lumen-length L1 of lumen 23 of handle 24 is long enough to accommodate shaft-length L2 of proximal portion 241 of shaft 22. In response to the sliding of shaft 22, the distal portion of the exposed overtube 90 and torque-delivering-tool 26 defines a torque-delivering-tool-length L3 at a distal portion thereof that is equal to shaft-length L2 of proximal portion 241 of shaft 22. Thus, handle-lumen-length L1, shaft-length L2 at proximal portion 241 of shaft 22, and torque-delivering-tool-length L3 at the distal portion thereof are equal and have a ratio of between 0.7:1 and 1.3:1.
Reference is now made to FIGS. 3 and 5E. FIG. 5E shows the adjustment of longitudinal members 60 and 62 by adjusting mechanism 40 and delivery tool 20. During the adjustment of longitudinal members 60 and 62, locking mechanism 45 of adjustment mechanism 40 is disposed in an unlocked state with respect to spool 46 (as shown in FIG. 3). Rotating structure 32 is rotated in a first direction thereof, as indicated by arrow A. In response to the rotation of structure 32, torque-delivering-tool 26 is rotated. Responsively, screwdriver head 95 that is coupled to the distal end of torque-delivering-tool 26 is rotated and spool-rotating portion 94 pushes against the wall defining channel 48 of spool 46. Such pushing applies an annular force to the spool which facilitates rotation of spool 46 in a first direction thereof.
Overtube 90 comprises a tube which surrounds torque-delivering-tool 26. Since shaft 22 is retracted proximally (as shown) during the adjustment of longitudinal members 60 and 62, overtube 90 functions to provide rigidity and stability to torque-delivering-tool 26 as it delivers torque to spool 46. Overtube 90 comprises a flexible material, e.g., polyamide, ePTFE, or PTFE. In some embodiments, the material of overtube 90 is braided. For some applications, overtube 90 is coated with PTFE.
Following the adjustment of the respective lengths of longitudinal members 60 and 62, delivery tool 20 is decoupled from spool assembly 240. The operating physician pushes on rotating structure 32, in the direction as indicated by arrow B in FIG. 5E. The proximal portion of handle 24 is shaped to define a recessed portion for receiving a distal portion of rotating structure 32 in response to the pushing thereof. Pushing on rotating structure 32 thereby pushes torque-delivering-tool 26 coupled thereto. Responsively, screwdriver head 95 that is coupled to torque-delivering-tool 26 is pushed distally. As screwdriver head 95 is pushed, shelf portion 91 pushes against upper surface 41 of housing 42 in order to facilitate pulling of tool 20 away from spool assembly 240. Responsively, screwdriver head 95 and graspers 30 are distanced from housing 42, as shown in the enlarged cross-sectional image of adjustment mechanism 40.
Once free of tool 20, the operating physician may then repair any other defect in the heart without any obstruction and interference by tool 20. In some cases, the operating physician introduces a second spool assembly 240 into another implantation site in the left ventricle and repairs another portion of heart 2. In some embodiments, the second spool assembly is implanted in a second papillary muscle of the ventricle and the longitudinal member(s) coupled thereto are coupled at their free ends to either leaflet 12 or 14. The longitudinal member(s) then function as secondary artificial chordae tendineae.
In some embodiments, the second spool assembly 240 is coupled to a first portion of the ventricle wall (i.e., and not to the papillary muscle) at the base of the papillary muscle, or at another portion of the ventricle wall which faces and surrounds the ventricular lumen of heart 2. In some embodiments, the free ends of the longitudinal member(s) coupled to the second spool assembly are coupled to either leaflet 12 or 14 (as shown hereinbelow with reference to FIG. 8). Alternatively, the free ends of the longitudinal member(s) are coupled to a second portion of the ventricle wall (as shown hereinbelow with reference to FIGS. 10A-B) in order to draw the first and second portions the ventricle wall toward each other.
FIG. 6 is a schematic illustration of extracardiac apparatus comprising torque-delivering-tool 26 accessing spool assembly 240 via port 320, in accordance with an embodiment of the present invention. The physician feels for bump 312 of skin 310 and creates a small incision in the tissue in order to access port 320. Torque-delivering-tool 26 is advanced through primary lumen 302 of guide tube 300 (as shown in the transverse cross-sectional image of guide tube 300) and accesses adjusting mechanism 40 of spool assembly 240 from a site outside the body of the patient.
Torque-delivering-tool 26 is coupled at a distal end thereof to screwdriver head 95. Screwdriver head 95 accesses spool 46 of adjustment mechanism 40 and rotates spool 46 (in a manner as described hereinabove) in order to adjust longitudinal members 60 and 62. The readjustment procedure is typically performed with the aid of imaging, such as fluoroscopy, transesophageal echo, and/or echocardiography.
Reference is now made to FIG. 7, which is a schematic illustration of a system 400 for implanting spool assembly 240 and adjusting longitudinal members 60 and 62, as described hereinabove with reference to FIGS. 5A-G, with the exception that guide wires 160 and 162 do not remain partially disposed within heart 2, in accordance with an embodiment of the present invention. In such an embodiment, guide wires 160 and 162 are used only during the initial implantation of spool assembly 240 and adjustment of longitudinal members 60 and 62. Guide wires 160 and 162 in this embodiment, facilitate the removal of tool 20 from heart 2 and the replacement of tool 20 in heart 2 during the initial procedure.
Tissue anchor 50 is corkscrewed into the cardiac tissue in a manner in which it is disposed fully within portion 200 of the heart tissue, e.g., endocardium or myocardium, and does not extend beyond a pericardium 202 of heart 2.
Reference is now made to FIGS. 9, 10A-B, and 11 which are schematic illustrations of respective systems for repairing malpositioning of the wall of the ventricle of the patient, in accordance with respective embodiments of the present invention. FIG. 9 is a schematic illustration of heart 2 in a weakened state in which the wall of the left ventricle is malpositioned and weakened. As a result, leaflets 12 and 14 of mitral valve 8 are malpositioned and are distanced from each other.
FIG. 10A shows system 600 comprising spool assembly 240 implanted at a first portion 420 of heart tissue which faces and surrounds the left ventricle of heart 2. First implantation site 5 thus comprises first portion 420 of heart tissue. Spool assembly 240 is implanted via tool 20 at site 5 in a manner as described hereinabove with reference to FIGS. 5A-G. The free ends of longitudinal members 60 and 62 are coupled to a second portion 422 of heart tissue which faces and surrounds the left ventricle of heart 2. Second implantation site 7 thus comprises second portion 422 of heart tissue, e.g., at the septum, by way of illustration and not limitation. The free ends of longitudinal members 60 and 62 are coupled to the heart tissue using any suitable attachment means 602, e.g., sutures, knotting, or tissue anchors such as helical anchors. Spool 46 of adjustment mechanism 40 is rotated by tool 20, as described hereinabove, thereby pulling tight longitudinal members 60 and 62 and thereby reducing a length of longitudinal members 60 and 62 between first and second implantation sites 5 and 7. In response to the pulling of longitudinal members 60 and 62, first and second portions 420 and 422 of the heart tissue are pulled toward each other. Consequently, the dimensions of the heart wall are restored to physiological dimensions, and leaflets 12 and 14 are drawn toward each other.
FIG. 10B shows system 700 for adjusting a distance between two portions of a heart wall of the left ventricle of the patient. Longitudinal members 60 and 62 are coupled at first portions thereof to spool 46 of adjustment mechanism 40. Respective free ends of each member 60 and 62 are coupled to opposing first and second portions of the heart wall which faces and surrounds the ventricular lumen of heart 2. The free end of longitudinal member 62 is coupled to first implantation site 5 using a first helical anchor 750 by way of illustration and not limitation. For example, the free end of longitudinal member 62 is coupled to first implantation site 5 using sutures, knots, or any tissue anchor known in the art. The free end of longitudinal member 60 is coupled to second implantation site 7 using a second helical anchor 750 by way of illustration and not limitation. For example, the free end of longitudinal member 60 is coupled to second implantation site 7 using sutures, knots, or any tissue anchor known in the art. In such a configuration, adjustment mechanism 40 is disposed between longitudinal members 60 and 62 and is not directly coupled to heart tissue.
Following the attaching of longitudinal members 60 and 62 to implantation sites 5 and 7, respectively, spool 46 of adjustment mechanism 40 may be rotated using tool 20, in a manner as described hereinabove. As described hereinabove, using tool 20, spool 46 of adjustment mechanism 40 is rotated in order to adjust a distance between first and second implantation sites 5 and 7. Responsively, the first and second portions of the ventricle wall are drawn together. Consequently, the dimensions of the heart wall are restored to physiological dimensions, and leaflets 12 and 14 are drawn toward each other.
FIG. 11 is a schematic illustration of a system 800 for adjusting a distance between two portions of a heart wall of the left ventricle of the patient. System 800 comprises a tensioning device 802 coupled at a first end thereof to spool assembly 240. In a manner as described hereinabove, using tool 20, spool assembly 240 is implanted at first implantation site 5 in a first portion of tissue of the heart wall that faces and surrounds the ventricular lumen. The free end, i.e., second portion, of tensioning device 802 is attached at second implantation site 7 to a second portion of tissue of the heart wall that faces and surrounds the ventricular lumen. The free end of tensioning device 802 is implanted in heart tissue using a helical anchor by way of illustration and not limitation. For example, the free end of tensioning device 802 may be coupled to second implantation site 7 using sutures, knots, or any tissue anchor known in the art.
As described hereinabove, using tool 20, spool 46 of adjustment mechanism 40 is rotated in order to adjust a distance between first and second implantation sites 5 and 7. As spool 46 is rotated in a first direction thereof, suture portion 804 that is disposed adjacently to spool assembly 240 is wrapped around spool 46. Tensioning device 802 is tightened and shortened in response to the wrapping of portion 804 around spool 46. As device 802 is tightened, a force is applied to coiled portion 806 of tensioning device 802. Coiled portion 806 applies a supplemental pulling force to help pull the opposing first and second portions of the ventricle wall toward each other. Consequently, the dimensions of the heart wall are restored to physiological dimensions, and leaflets 12 and 14 are drawn toward each other.
Reference is again made to FIGS. 9-11. It is to be noted that the scope of the present invention includes the use of systems 600, 700, and 800 for adjusting a distance between any two portions of the heart and not just opposing portions, as described hereinabove. For example, first and second implantation sites 5 and 7 may be on the same side, e.g., the septum, of the wall of the heart.
Reference is now made to FIGS. 12A-B which are schematic illustrations of a system 900 for drawing together leaflets 12 and 14 of a mitral valve of the patient, in accordance with an embodiment of the present invention. Spool assembly 240 is implanted in first implantation site 5 at papillary muscle 4 of the left ventricle by way of illustration and not limitation. For example, spool assembly 240 may be implanted in a portion of the heart wall of the ventricle, e.g., the base of the papillary muscle. As described hereinabove respective first portions of each longitudinal member 60 and 62 are coupled to spool 46 of adjustment mechanism 40. The free end, i.e., second portion, of longitudinal member 60 is coupled, e.g., sutured, anchored, clipped, locked in place with a crimping bead, to leaflet 12 at an implantation site 902. The free end, i.e., second portion, of longitudinal member 62 is coupled, e.g., sutured, anchored, clipped, locked in place with a crimping bead, to leaflet 14 at an implantation site 904.
As described hereinabove, using tool 20, spool 46 of adjustment mechanism 40 is rotated in order to adjust a length of longitudinal members 60 and 62. As shown in FIG. 12B, longitudinal members 60 and 62 are pulled tight in response to rotation of spool 46 in a first direction thereof. In response to the pulling of longitudinal members 60 and 62 leaflets 12 and 14 are pulled toward each other in order to restore coaptation to valve 8.
(1) the free end of longitudinal member 60 is coupled to, e.g., sutured to or anchored to, a second implantation site (e.g., another portion of the inner wall of the heart that faces and surrounds the ventricle),
(3) rotation of spool 46 draws the first, second, and third implantation sites toward each other.
Reference is now made to FIGS. 1-12A-B. It is to be noted that the shortening of longitudinal members 60 and 62 described herein is reversible. That is, rotating spool 46 in a rotational direction that opposes the rotational direction used to shorten the longitudinal members, unwinds respective portions of the longitudinal members from around spool 46. Unwinding the portion of the longitudinal members from around spool 46 thus slackens the remaining portions of the longitudinal members that are disposed between first and second implantation sites 5 and 7. Responsively, the longitudinal members are elongated (i.e., with respect to their shortened states state prior to the unwinding).
Reference is yet again made to FIGS. 1-12A-B. It is to be noted that following initial adjustment of the repair chords, the repair chords may be further adjusted at a later state following the initial implantation thereof. Using real-time monitoring, tactile feedback and optionally in combination with fluoroscopic imaging, tool 20 may be reintroduced within the heart and engage spool 46.
It is to be noted that systems 10, 400, 500, and 900 may be used as artificial chordae tendineae to replace stretched native chordae tendineae of a left ventricle or of a right ventricle. For some applications, spool assembly 240 is coupled to the papillary muscle. For such applications, spool assembly 240 is coupled to a portion of the wall of the ventricular lumen.
Reference is still yet again made to FIGS. 1-12A-B. It is to be noted that first implantation site 5 may be any portion of tissue that faces and surrounds the ventricle of the heart of the patient. For example, first implantation site 5 may include a first portion of tissue of an inner wall of the ventricle at the base of the papillary muscle or any other suitable location along the inner wall. First implantation site 5 may also include tissue of the papillary muscle. It is to be noted that second implantation site 7 may be any portion of tissue that faces and surrounds the ventricle of the heart of the patient. For example, second implantation site 7 may include a second portion of tissue of an inner wall of the ventricle at the septum, or any other suitable location along the inner wall. Second implantation site 7 may also include a leaflet of an atrioventricular valve of the heart of the patient.
Reference is still yet again made to FIGS. 1-12A-B. It is to be noted that systems described herein may be used to repair the heart during open-heart, minimally-invasive, and transcatheter procedures. For embodiments in which delivery tool 20 is introduced within the heart during minimally-invasive and transcatheter procedures, shaft 22, torque-delivering-tool 26, and overtube 90 are longer than as shown hereinabove. For such applications, suture needle 64 coupled to the longitudinal member is coupled to needle holder 70 of tool 20 in a manner in which needle 64 faces outward. In such a configuration, the piercing portion, e.g., a barbed portion, of needle 64 is exposed from slit 72 of holder 70. In such an embodiment, needle holder 70 may be coupled to a distal portion of shaft 22.
For transcatheter procedures, delivery tool 20 is advanced toward the heart through an advancement catheter, e.g., a 12-13 F catheter. The advancement catheter facilitates a traumatic advancement of tool 20 through vasculature of the patient by providing an overtube which covers the outwardly-facing needle 64 of tool 20.
Spool assembly 240 is then adjusted in a manner as described hereinabove in order to adjust a distance between the second portion of the longitudinal member and spool assembly 240, and thereby create an adjustable artificial chordae tendineae that resembles the native chordae tendineae. Following the adjusting of the longitudinal member, delivery tool 20 is decoupled from spool assembly 240, as described hereinabove, and tool 20 and the advancement catheter are extracted from within the body of the patient.
Reference is still yet again made to FIGS. 1-12A-B. It is to be noted that spool housing 42 and spool 46 may be implanted in a first portion of tissue of the heart independently of tool 20 and tissue anchor 50. In such an embodiment, spool housing 42 is sutured to tissue of the ventricle. Prior to implantation of housing 42, a longitudinal member is coupled to, e.g., knotted to, welded to, looped through, spool 46 at a first portion thereof. The second portion of spool 46 is coupled to, e.g., knotted to, sutured to, or anchored to, a second portion of tissue of the heart. Spool 46 may be rotated using any suitable screwdriver or screwdriver head 95, as described hereinabove.
Reference is still yet again made to FIGS. 1-12A-B. Spool 46 may be coupled to the heart tissue in a manner in which a central longitudinal axis through spool 46 forms an angle with a surface of the heart tissue of between about 30 and 180 degrees, e.g., between about 75 and 90 degrees, such as about 90 degrees. In some embodiments, spool 46 is coupled to the heart tissue in a manner in which the central longitudinal axis is parallel with the surface of the heart tissue.
Additionally, the scope of the present invention includes embodiments described in one or more of the following:
PCT Publication WO 06/097931 to Gross et al., entitled, �Mitral Valve treatment techniques,� filed Mar. 15, 2006; U.S. Provisional Patent Application 60/873,075 to Gross et al., entitled, �Mitral valve closure techniques,� filed Dec. 5, 2006; U.S. Provisional Patent Application 60/902,146 to Gross et al., entitled, �Mitral valve closure techniques,� filed on Feb. 16, 2007; U.S. Provisional Patent Application 61/001,013 to Gross et al., entitled, �Segmented ring placement,� filed Oct. 29, 2007; PCT Patent Application PCT/IL07/001,503 to Gross et al., entitled, �Segmented ring placement,� filed on Dec. 5, 2007, which published as WO 08/068,756; U.S. Provisional Patent Application 61/132,295 to Gross et al., entitled, �Annuloplasty devices and methods of delivery therefor,� filed on Jun. 16, 2008; U.S. patent application Ser. No. 12/341,960 to Cabiri, entitled, �Adjustable partial annuloplasty ring and mechanism therefor,� filed on Dec. 22, 2008, which published as US 2010/0161047; U.S. Provisional Patent Application 61/207,908, to Miller et al., entitled, �Actively-engageable movement-restriction mechanism for use with an annuloplasty structure,� filed on Feb. 17, 2009; A US patent application entitled �Annuloplasty ring with intra-ring anchoring�; U.S. Pat. No. 7,431,692 to Zollinger et al.; and U.S. Patent Application Publication 2007/0118151 to Davidson. All of these applications are incorporated herein by reference. Techniques described herein can be practiced in combination with techniques described in one or more of these applications.
Patent CitationsCited PatentFiling datePublication dateApplicantTitleUS4602911Jan 25, 1985Jul 29, 1986General Resorts S.A.Adjustable ringprosthesisUS4917698Dec 22, 1988Apr 17, 1990Baxter International Inc.Multi-segmented annuloplasty ring prosthesisUS5061277Sep 2, 1988Oct 29, 1991Baxter International Inc.Flexible cardiac valvular support prosthesisUS5104407Sep 20, 1990Apr 14, 1992Baxter International Inc.Selectively flexible annuloplasty ringUS5306296Aug 21, 1992Apr 26, 1994Medtronic, Inc.Annuloplasty and suture ringsUS5477856Mar 24, 1994Dec 26, 1995Lundquist; Ingemar H.Torquable catheter and torquable tubular member for use therewithUS5601572 *Jun 7, 1995Feb 11, 1997Raychem CorporationDevice or apparatus for manipulating matter having a elastic ring clipUS5669919Aug 16, 1996Sep 23, 1997Medtronic, Inc.Annuloplasty systemUS5674279Jun 29, 1995Oct 7, 1997Medtronic, Inc.Annuloplasty and suture ringsUS5876373Apr 4, 1997Mar 2, 1999Eclipse Surgical Technologies, Inc.Steerable catheterUS5961440Sep 18, 1997Oct 5, 1999Myocor, Inc.For the treatment of a failing heartUS5961539Jan 17, 1997Oct 5, 1999Segmed, Inc.Method and apparatus for sizing, stabilizing and/or reducing the circumference of an anatomical structureUS6045497Jul 29, 1998Apr 4, 2000Myocor, Inc.Heart wall tension reduction apparatus and methodUS6050936Jan 2, 1997Apr 18, 2000Myocor, Inc.Heart wall tension reduction apparatusUS6059715Jan 4, 1999May 9, 2000Myocor, Inc.Heart wall tension reduction apparatusUS6165119Jan 4, 1999Dec 26, 2000Myocor, Inc.Heart wall tension reduction apparatus and methodUS6251092Dec 30, 1997Jun 26, 2001Medtronic, Inc.Deflectable guiding catheterUS6315784 *Feb 3, 1999Nov 13, 2001Zarija DjurovicSurgical suturing unitUS6319281Mar 22, 1999Nov 20, 2001Kumar R. PatelArtificial venous valve and sizing catheterUS6332893Dec 17, 1997Dec 25, 2001Myocor, Inc.Valve to myocardium tension members device and methodUS6406420Oct 21, 1999Jun 18, 2002Myocor, Inc.Methods and devices for improving cardiac function in heartsUS6451054Oct 25, 1999Sep 17, 2002Hearport, Inc.Less-invasive devices and methods for treatment of cardiac valvesUS6524338Aug 25, 2000Feb 25, 2003Steven R. GundryMethod and apparatus for stapling an annuloplasty band in-situUS6537314Jan 30, 2001Mar 25, 2003Ev3 Santa Rosa, Inc.Percutaneous mitral annuloplasty and cardiac reinforcementUS6554845 *Sep 15, 2000Apr 29, 2003PAR� Surgical, Inc.Suturing apparatus and methodUS6564805Jul 18, 2002May 20, 2003Heartport, Inc.Less-invasive devices and methods for treatment of cardiac valvesUS6569198Mar 30, 2001May 27, 2003Richard A. WilsonMitral or tricuspid valve annuloplasty prosthetic deviceUS6589160Nov 2, 2001Jul 8, 2003Myocor, Inc.Heart wall tension reduction apparatusUS6602288Oct 5, 2000Aug 5, 2003Edwards Lifesciences CorporationMinimally-invasive annuloplasty repair segment delivery template, system and method of useUS6602289Jun 8, 1999Aug 5, 2003S&A Rings, LlcAnnuloplasty rings of particular use in surgery for the mitral valveUS6619291Apr 24, 2001Sep 16, 2003Edwin J. HlavkaMethod and apparatus for catheter-based annuloplastyUS6626899Jul 3, 2001Sep 30, 2003Nidus Medical, LlcApparatus and methods for treating tissueUS6626930May 1, 2000Sep 30, 2003Edwards Lifesciences CorporationMinimally invasive mitral valve repair method and apparatusUS6629534Apr 7, 2000Oct 7, 2003Evalve, Inc.Methods and apparatus for cardiac valve repairUS6651671Oct 12, 1999Nov 25, 2003Heartport, Inc.Lens-invasive devices and methods for cardiac valve surgeryUS6682558May 10, 2001Jan 27, 20043F Therapeutics, Inc.Delivery system for a stentless valve bioprosthesisUS6689164Oct 10, 2000Feb 10, 2004Jacques SeguinAnnuloplasty device for use in minimally invasive procedureUS6695866Apr 5, 2000Feb 24, 2004St. Jude Medical, Inc.Mitral and tricuspid valve repairUS6702826Jun 22, 2001Mar 9, 2004Viacor, Inc.Automated annular plication for mitral valve repairUS6718985May 25, 2001Apr 13, 2004Edwin J. HlavkaMethod and apparatus for catheter-based annuloplasty using local plicationsUS6723038Oct 6, 2000Apr 20, 2004Myocor, Inc.Methods and devices for improving mitral valve functionUS6726717May 15, 2002Apr 27, 2004Edwards Lifesciences CorporationAnnular prosthesis for mitral valveUS6749630Aug 28, 2001Jun 15, 2004Edwards Lifesciences CorporationTricuspid ring and templateUS6752813Jun 27, 2001Jun 22, 2004Evalve, Inc.Methods and devices for capturing and fixing leaflets in valve repairUS6764510Jan 9, 2002Jul 20, 2004Myocor, Inc.Devices and methods for heart valve treatmentUS6786924Mar 12, 2002Sep 7, 2004Medtronic, Inc.Annuloplasty band and methodUS6802319Mar 24, 2000Oct 12, 2004John H. StevensMinimally-invasive devices and methods for treatment of congestive heart failureUS6805710Oct 9, 2002Oct 19, 2004Edwards Lifesciences CorporationMitral valve annuloplasty ring for molding left ventricle geometryUS6858039Jul 8, 2002Feb 22, 2005Edwards Lifesciences CorporationMitral valve annuloplasty ring having a posterior bowUS6893459Sep 20, 2000May 17, 2005Ample Medical, Inc.Heart valve annulus device and method of using sameUS6908482May 3, 2002Jun 21, 2005Edwards Lifesciences CorporationThree-dimensional annuloplasty ring and templateUS6986775Jun 13, 2003Jan 17, 2006Guided Delivery Systems, Inc.Devices and methods for heart valve repairUS6989028Jan 30, 2002Jan 24, 2006Edwards Lifesciences AgMedical system and method for remodeling an extravascular tissue structureUS7004176Oct 17, 2003Feb 28, 2006Edwards Lifesciences AgHeart valve leaflet locatorUS7011669Mar 10, 2003Mar 14, 2006Edwards Lifesciences CorporationDevice and method for treatment of atrioventricular regurgitationUS7011682Aug 5, 2003Mar 14, 2006Edwards Lifesciences AgMethods and apparatus for remodeling an extravascular tissue structureUS7037334Jul 18, 2003May 2, 2006Mitralign, Inc.Method and apparatus for catheter-based annuloplasty using local plicationsUS7101395Jun 12, 2003Sep 5, 2006Mitral Interventions, Inc.Method and apparatus for tissue connectionUS7112207Apr 24, 2003Sep 26, 2006Edwards Lifesciences CorporationMinimally invasive mitral valve repair method and apparatusUS7125421Aug 30, 2002Oct 24, 2006Mitral Interventions, Inc.Method and apparatus for valve repairUS7175660Aug 29, 2003Feb 13, 2007Mitralsolutions, Inc.Apparatus for implanting surgical devices for controlling the internal circumference of an anatomic orifice or lumenUS7186262Jul 3, 2002Mar 6, 2007Vahid SaadatApparatus and methods for treating tissueUS7189199May 2, 2002Mar 13, 2007Myocor, Inc.Methods and devices for improving cardiac function in heartsUS7226467May 19, 2003Jun 5, 2007Evalve, Inc.Fixation device delivery catheter, systems and methods of useUS7294148Apr 29, 2004Nov 13, 2007Edwards Lifesciences CorporationAnnuloplasty ring for mitral valve prolapseUS7297150Aug 29, 2003Nov 20, 2007Mitralsolutions, Inc.Implantable devices for controlling the internal circumference of an anatomic orifice or lumenUS7311728Sep 29, 2004Dec 25, 2007Edwards Lifesciences AgDevice and method for treatment of mitral insufficiencyUS7329280Oct 18, 2004Feb 12, 2008Edwards Lifesciences Corp.Methods of implanting a mitral valve annuloplasty ring to correct mitral regurgitationUS7404824Nov 12, 2003Jul 29, 2008Advanced Cardiovascular Systems, Inc.Valve aptation assist deviceUS7431692Mar 9, 2006Oct 7, 2008Edwards Lifesciences CorporationApparatus, system, and method for applying and adjusting a tensioning element to a hollow body organUS7452376May 10, 2005Nov 18, 2008St. Jude Medical, Inc.Flexible, non-planar annuloplasty ringsUS7455690Aug 29, 2003Nov 25, 2008Mitralsolutions, Inc.Methods for controlling the internal circumference of an anatomic orifice or lumenUS7507252Aug 5, 2003Mar 24, 2009Edwards Lifesciences AgAdjustable transluminal annuloplasty systemUS7563267May 19, 2003Jul 21, 2009Evalve, Inc.Fixation device and methods for engaging tissueUS7563273Mar 17, 2004Jul 21, 2009Evalve, Inc.Methods and devices for capturing and fixing leaflets in valve repairUS7588582Oct 20, 2005Sep 15, 2009Guided Delivery Systems Inc.Methods for remodeling cardiac tissueUS7604646May 16, 2005Oct 20, 2009Evalve, Inc.Locking mechanisms for fixation devices and methods of engaging tissueUS7608091Jul 3, 2003Oct 27, 2009Evalve, Inc.Methods and apparatus for cardiac valve repairUS7608103Jan 31, 2005Oct 27, 2009Edwards Lifesciences CorporationMitral valve annuloplasty ring having a posterior bowUS7618449Sep 1, 2006Nov 17, 2009Mitral InterventionsMethod and apparatus for tissue connectionUS7635329Sep 27, 2005Dec 22, 2009Evalve, Inc.Methods and devices for tissue grasping and assessmentUS7635386Mar 7, 2007Dec 22, 2009University Of Maryland, BaltimoreMethods and devices for performing cardiac valve repairUS7655015Dec 21, 2007Feb 2, 2010Evalve, Inc.Fixation devices, systems and methods for engaging tissueUS20020087048Nov 16, 2001Jul 4, 2002Brock David L.Flexible instrumentUS20020103532Jul 19, 2001Aug 1, 2002Langberg Jonathan J.Transluminal mitral annuloplastyUS20020173841May 14, 2002Nov 21, 2002Paul A. SpenceAnnuloplasty devices and related heart valve repair methodsUS20030050693Sep 10, 2001Mar 13, 2003Quijano Rodolfo C.Minimally invasive delivery system for annuloplasty ringsUS20030105519Sep 4, 1998Jun 5, 2003Roland FasolArtificial chordae replacementUS20030167062Mar 5, 2001Sep 4, 2003Gambale Richard ASuture clips,delivery devices and methodsUS20030233142Jun 13, 2003Dec 18, 2003Guided Delivery Systems, Inc.Devices and methods for heart valve repairUS20040024451Jan 2, 2003Feb 5, 2004Medtronic, Inc.Prosthetic heart valve systemUS20040122514Jan 31, 2003Jun 24, 2004Fogarty Thomas J.Biologically implantable prosthesis and methods of using the sameUS20040148021Aug 29, 2003Jul 29, 2004Cartledge Richard G.Implantable devices for controlling the internal circumference of an anatomic orifice or lumenUS20040236419Jun 21, 2004Nov 25, 2004Simcha MiloImplantation system for annuloplasty ringsUS20050004668Jul 2, 2004Jan 6, 2005Flexcor, Inc.Annuloplasty rings and methods for repairing cardiac valvesUS20050055087Sep 4, 2003Mar 10, 2005Guided Delivery Systems, Inc.Devices and methods for cardiac annulus stabilization and treatmentUS20050060030Jul 19, 2004Mar 17, 2005Lashinski Randall T.Remotely activated mitral annuloplasty system and methodsUS20050090827Oct 28, 2003Apr 28, 2005Tewodros GedebouComprehensive tissue attachment systemUS20050171601Mar 30, 2005Aug 4, 2005Cosgrove Delos M.Minimally-invasive annuloplasty repair segment delivery systemUS20050288781May 6, 2005Dec 29, 2005Shahram MoaddebAdjustable cardiac valve implant with ferromagnetic materialUS20060025787Sep 27, 2005Feb 2, 2006Guided Delivery Systems, Inc.Devices and methods for heart valve repairUS20060041319Oct 21, 2005Feb 23, 2006Reflux CorporationPerorally removeable anti-reflux valve implantationUS20090299409 *May 30, 2008Dec 3, 2009Ethicon Endo-Surgery, Inc.Endoscopic suturing tension controlling and indication devices* Cited by examinerNon-Patent CitationsReference1"Two dimensional real-time ultrasonic imaging of the heart and great vessels", Mayo Clin Proc. vol. 53:271-303, 1978.2An International Search Report dated Jun. 10, 2010, which issued during the prosecution of Applicant's PCT/IL09/01209.3An International Search Report dated Sep. 8, 2009, which issued during the prosecution of Applicant's PCT/IL09/00593.4An Office Action dated Apr. 6, 2010, which issued during the prosecution of Applicant's U.S. Appl. No. 12/484,512.5Dieter RS, "Percutaneous valve repair: Update on mitral regurgitation and endovascular approaches to the mitral valve," Applications in Imaging, Cardiac Interventions, Supported by an educational grant from Amersham Health pp. 11-14 (2003).6Odell JA et al., "Early Results of a Simplified Method of Mitral Valve Annuloplasty," Circulation 92:150-154 (1995).7O'Reilly S et al., "Heart valve surgery pushes the envelope," Medtech Insight 8(3): 73, 99-108 (2006).8Swain CP et al., "An endoscopically deliverable tissue-transfixing device for securing biosensors in the gastrointestinal tract," Gastrointestinal Endoscopy 40(6): 730-734 (1994).9U.S. Appl. No. 60/873,075, filed Dec. 5, 2006.10U.S. Appl. No. 60/902,146, filed Feb. 16, 2007.11U.S. Appl. No. 61/001,013, filed Oct. 29, 2007.12U.S. Appl. No. 61/132,295, filed Jun. 16, 2008.Referenced byCiting PatentFiling datePublication dateApplicantTitleUS8500800Sep 21, 2009Aug 6, 2013Valtech Cardio Ltd.Implantation of repair chords in the heartUS8734467 *Dec 2, 2010May 27, 2014Valtech Cardio, Ltd.Delivery tool for implantation of spool assembly coupled to a helical anchorUS20110282361 *Dec 2, 2010Nov 17, 2011Eran MillerDelivery tool for implantation of spool assembly coupled to a helical anchor* Cited by examinerClassifications U.S. Classification623/2.11International ClassificationA61F2/24Cooperative ClassificationA61B2017/0496, A61B2017/0414, A61B2017/12095, A61B2017/0464, A61F2/2487, A61F2/2457, A61F2/2466, A61B2017/0441, A61B2017/00243, A61B2017/0649, A61B17/0401, A61B2017/0409European ClassificationA61B17/04A, A61F2/24W4, A61F2/24R6BLegal EventsDateCodeEventDescriptionJul 13, 2009ASAssignmentOwner name: VALTECH CARDIO, LTD.,ISRAELFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MAISANO, FRANCESCO;MILLER, ERAN;CABIRI, OZ AND OTHERS;SIGNED BETWEEN 20090614 AND 20090617;REEL/FRAME:22945/984Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:MAISANO, FRANCESCO;MILLER, ERAN;CABIRI, OZ;AND OTHERS;SIGNING DATES FROM 20090614 TO 20090617;REEL/FRAME:022945/0984Owner name: VALTECH CARDIO, LTD., ISRAELRotateOriginal ImageGoogle Home - Sitemap - USPTO Bulk Downloads - Privacy Policy - Terms of Service - About Google Patents - Send FeedbackData provided by IFI CLAIMS Patent Services©2012 Google