Source: https://patents.google.com/patent/US8591576B2/en
Timestamp: 2019-02-20 23:41:57
Document Index: 296821080

Matched Legal Cases: ['art 100', 'art 100', 'art 100', 'art 62', 'art 100', 'art 330']

US8591576B2 - Method for altering the geometry of the heart - Google Patents
Method for altering the geometry of the heart Download PDF
US8591576B2
US8591576B2 US13/396,498 US201213396498A US8591576B2 US 8591576 B2 US8591576 B2 US 8591576B2 US 201213396498 A US201213396498 A US 201213396498A US 8591576 B2 US8591576 B2 US 8591576B2
upper aperture
US13/396,498
US20120143323A1 (en
2006-05-15 Priority to DKPA200600684 priority Critical
2006-05-15 Priority to DKPA200600684 priority
2006-05-15 Priority to DK200600684 priority
2006-05-31 Priority to US80938306P priority
2007-05-15 Priority to PCT/DK2007/050058 priority patent/WO2007131513A1/en
2009-06-05 Priority to US30078609A priority
2012-02-14 Priority to US13/396,498 priority patent/US8591576B2/en
2012-02-14 Application filed by Edwards Lifesciences AG filed Critical Edwards Lifesciences AG
2012-05-17 Assigned to EDWARDS LIFESCIENCES AG reassignment EDWARDS LIFESCIENCES AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ENOVACOR APS
2012-05-17 Assigned to ENOVACOR APS reassignment ENOVACOR APS ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HASENKAM, JOHN MICHAEL, NIELSEN, STEN LYAGER, SMERUP, MORTEN
2012-06-07 Publication of US20120143323A1 publication Critical patent/US20120143323A1/en
2012-06-13 Assigned to ENOVACOR APS reassignment ENOVACOR APS ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: HASENKAM, JOHN MICHAEL, NIELSEN, STEN LYAGER, SMERUP, MORTEN
2012-06-13 Assigned to EDWARDS LIFESCIENCES AG reassignment EDWARDS LIFESCIENCES AG ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ENOVACOR APS
2013-11-26 Publication of US8591576B2 publication Critical patent/US8591576B2/en
The tension system comprises a set of tension members 21, 22, 23, 24, e.g. in the form of strings or sutures. Each of the tension members comprises a first end 21 a, 22 a, 23 a, 24 a and a second end 21 b, 22 b, 23 b, 24 b, respectively. The first ends 21 a, 22 a, 23 a, 24 a are intended to be led to a position at the exterior of the heart for adjustment of a set of anatomical lengths/distances defining the geometry of the ventricle 110 of the heart 100. The second ends 21 b, 22 b, 23 b, 24 b are intended for fixture to a position on or through the papillary muscles 170.
The lower side 10 b apertures 12, 13 are preferably situated diametrically across from each other. Two tension members 21, 22 extend through one of the lower apertures 12 and two other members 23, 24 are carried through the other of the lower side apertures 13. The above mentioned apertures 11, 12, 13 may be reinforced along the rim of the apertures 12, 12, 13 in order to increase the resistance to wear and tear of tension members being moved/drawn with respect to the apertures. In an embodiment (not shown) the lower (ventricle) side 11 b of the annuloplasty ring 10 may be provide with one aperture for each tension member 21, 22, 23, 24.
Some or all of the anchors 30, 31, 32, 34 may be anchored to other points within the ventricle 11, apart from the papillary tips 170 a, 171 b, in suitable places on the ventricular wall.
The annuloplasty ring 210 is attachable to an annulus 180 of the heart 100. It has an upper side 210 a and a lower side 210 b which, when the ring 210 is inserted in the heart 100, is intended to face the atrium 150 and the ventricle 110, respectively.
In another embodiment of this first aspect of a method according to the invention, using the system 1 shown and described in relation to FIG. 3 a further inter-papillary tension member 25 may be placed in the heart along with the valve-papillary tension members 21, 22, 23, 24. A second end 25 b of the inter-papillary tension member 25 is brought through the annulus 150 together with the second ends 21 b, 22 b, 23 b, 24 b of valve-papillary tension members 21, 22, 23, 24. An inter-papillary anchor 45 is then fixed to a tip 170 a of one of the papillary muscles 170. The ventricular end 25 b of the inter-papillary tension member 25 is then connected via the inter-papillary anchor 32 to the tip 170 a of the other papillary muscle 170, where it is fixated, by means of suitable anchors or other fixation means. Then the first end of the inter-papillary tension member 25 is exteriorized through the dome 151 of the left atrium 150 together with the first ends 21 a, 22 a, 23 a, 24 a of the valve-papillary tension members 21, 22, 23, 24, and adjusted (tightened or loosened relative to each other) to maximize cardiac function and valve competence. Hereafter the tension members 21, 22, 23, 24, 25 are tied in a standard surgical fashion, or tightened in a standard surgical fashion around an anchor 35 such as a special epicardial pad to reduce the local myocardial damage on the exterior side of the atrial dome 151. Thereby restoration of the normal continuity between the papillary muscles 170 and left ventricular wall and the mitral valve 130 may be accomplished.
An inter-papillary anchor 32 is then fixed to a tip 170 a of the other of the two papillary muscles 170 in connection with a passage pierced through the papillary muscle 170, either from the ventricular side 170 a of the papillary muscles 170, or from the epicardial aspect 170 b of the papillary muscle base on the exterior side of the ventricular wall. Then the first end 225 a of the inter-papillary tension member 225 is exteriorized via the inter-papillary anchor 32 through the passage.
Upon closing and resuming the heart rhythm, the annulus-papillary tension members 221, 222, 223, 224 are then adjusted by manipulating the second ends 221 b, 222 b, 223 b, 224 b of the valve-papillary tension members 221, 222, 23, 224, (tightened or loosened relative to each other) to maximize cardiac function and valve competence. Hereafter the tension members 221, 222, 223, 224, 225 tightened in a standard surgical fashion around an anchor 230 such as a special epicardial pad to reduce the local myocardial damage on the exterior side of the epicardial aspect 170 b of the papillary muscle base.
The tension members may be marked (texture) or color-coded texture in order to differentiate between the tension members, and thereby between the relevant anatomical lengths inside the beating heart to be adjusted. Markings/attachable signs could also be attached to the first ends 21 a, 22 a, 23 a, 24 a, 25 a, during the surgical procedure as each tension member is exteriorized in order to differentiate between the tension members/anatomical lengths when the adjustment step is to take place.
In a further embodiment of the first aspect of the system 1 according to the invention, and with reference to FIGS. 7A and 7B, the annuloplasty ring 10 may be provided with an extension tubing 60 communicating with the internal compartment 14 of the ring 10 through the aperture 11 in upper side 10 a of the ring 10. The extension tubing 60 is adapted to extend through the atrium 150 and through the atrium wall 151, and carries the first ends 21 a-24 a (or 25 a) of said tension members 21-24 (or 25). The extension tubing 60 is provided with means disposed at the end 61 closest to the annuloplasty ring 10 for squeezing of and fixating the tension members by turning of the extension tubing 60 around the longitudinal axis thereof. Thereby, the tension member length can be adjusted from the external side of the atrium on the beating heart by turning an externally extended part 62 of the extension tubing 60, thus securing the tension members in the correct position. By further providing the extension tubing 60 with a cutting mechanism (not shown), e.g. by an internal flange having a cutting edge, activated by further squeezing of and cutting the tension members, said cutting edge being disposed above said fixation point in said extension tubing 60, and being actuated by a further turning action of the extension tubing 60; and by means for cutting off at least a section of the extension tubing 60 itself (e.g. by a weakening of the wall of the extension tubing 60 above the cutting flange for the tension members, by further turning action) a major part of the extension tubing 60 can be pulled out of the atrium 150, leaving the tension members anchored at the annuloplasty ring 10 inside the atrium. Thus a restoration of the geometry of the heart can be accomplished from the atrium side, leaving no anchors on the atrium wall, which is thinner than e.g. the ventricle wall. Thus the atrium wall can be further relieved of some stress over the long term.
In yet a further embodiment of the first aspect of the system 1 according to the invention, and with reference to FIG. 8A-D, the annuloplasty ring 10 may be provided with an alternative system 40 for fixating said tension members 21-24 (or 25) at said atrium/upper side 10 a of said annuloplasty ring 10. In this embodiment the annuloplasty ring 10 is provided with a short upwardly directed tubular extension 41, communicating with the upper aperture 11. The tension members are extending through said tubular extension 41. In the tubular extension 41 a pin 45 having a threading is provided. The threading is adapted for cooperation with an internal threading of a plugging member 43 adapted to be received in said tubular extension 41. The tubular extension further has a cutting edge 42. The plug further has a conical outer surface for cooperation with said edge 42, and preferably a corresponding conical part in the upper part of the tubular extension 41 lumen. When the system 1 has been correctly inserted into the heart 100, the atrium has been closed (with the tension members extending therefrom), the heart rhythm has been reinstated and the heart has been correctly placed in the thorax, and the tension members has been adjusted to alter the geometry of the ventricle as desired, then the plugging member 43 can be turned using a suitable tool, e.g. as shown in FIG. 8D. By turning the plugging member 43 the plugging member is moved towards the annuloplasty ring 10 squeezing the corresponding conical surfaces on the tubular extension 41 and the plugging member 43 together, thus fixating the tension members. By a further turning the plugging member 43 the tension members are cut between the cutting edge 42 and the conical part of the plugging member 43.
In yet an embodiment of the first aspect of the system 1 according to the invention, and with reference to FIGS. 9-17, the annuloplasty ring 10 may be provided with an alternative system 40 for fixating said tension members 21-24 (and 25) at said atrium/upper side 10 a of said annuloplasty ring 10. In this embodiment, the annuloplasty ring 10 has a tension member hub 310 through which the tension members 21-25 are extended, the hub 310 providing means for fixating the tension members 21-25 when the desired length/tension has been achieved. As shown in FIG. 13, in an exploded, perspective view the annuloplasty ring 10 may have a saddle shape with a hub 310 at one side. Thus, the shape of the annuloplasty ring 10 is adapted to the natural shape of the annulus 180. However, the annuloplasty ring 10 may in other embodiments be e.g. circular or oval-shaped, or have other 3-dimentional configurations in order to adapt the annuloplasty ring to aid the restoration/repair of the individual annulus and mitral valve dilation.
In FIG. 13, it is shown that the annuloplasty ring 10 comprises a set of additional attachment holes 320 extending through the ring 10 from the atrium, upper side 10 a to the lower, ventricle side 10 b. These additional attachment holes 320 are provided as a means of sewing/stitching/suturing the ring 10 to the annulus 180 of the heart. However, other means for attachment/fixating the annuloplasty ring 10 to the annulus may be provided as alternative or as additional to the attachment holes 320. The annuloplasty ring 10 may e.g. be provided with a web of material on the outer surface of the ring 10, as known in the art, providing an anchoring for the suturing the ring 10 to the annulus.
The annuloplasty ring 10 has a set of apertures 11 provided in the upper/atrium side 10 a, for accommodating the tension members 21-25 extending from the atrium of the heart. The apertures 11 on the upper side 10 a communicate with a set of apertures 12, 13 on the lower (ventricle) side 10 b of the annuloplasty ring 10, from/to where a set of tension members 21-25 can be extended to be fixed to regions of the ventricle of a heart (when inserted into the heart of a human or animal). As seen in the FIGS. 13-16 all the apertures 11 on the upper side 10 a are located at the hub 310 in order to provide an easy way of adjusting and fixating the tension members from a position outside the heart and through the atrium. Some of the communicating apertures 11, 13 communicate via channels 313 through the annuloplasty ring 10 that are located in the vicinity of the hub 310, such that the lower side 10 b apertures 13 are located on or right next to the lower side of the hub 310. Other of the communicating apertures 11, 12 communicate via channels 312 through the annuloplasty ring 10 that extend from the upper side 10 a apertures 11 to the lower side 10 b apertures on positions arranged distributed over the lower surface 10 b of the ring 10. As shown, in the FIGS. 13-16 these lower side 10 b apertures 12 are preferably located at positions diametrically opposite the hub 310 in order to provide an optimal distribution of the tension members 21-25, to allow the best possible adjustment to restore or improve the geometry of the ventricle.
FIG. 16, as mentioned, also illustrates the path of a tension member 21-25 through the annuloplasty ring 10, as could be the situation when the ring 10 is fixed to the annulus, the tension members 21-25 being adjusted and fixed. The tension member 21-25 extends from the atrium side (up in the figure) down through a through hole 341 in the fastening member 340. Then the tension member 21-25 extends back up between the outer surface of the fastening member 340 and surface of the through hole 311 of the hub 310 and on between a flange 314 of the through hole 311 of the hub 310 and a lower surface 334 of the locking part 330. Here the tension member enters the hub 310 of the ring 10 through upper aperture 11 in the ring 10. The tension member is shown extending through a channel 313 in the vicinity of the hub 310 to aperture 13 and through the tissue surrounding the annulus and into the ventricle. Another tension member 21-25 (not shown in FIG. 16) would extend into channel 312 and to a position opposite the hub 310 or on another location on the circle of the annuloplasty ring lower side 10 b.
1. A method for adjusting, from outside the heart and while the heart is beating, the distance between a native heart valve annulus and associated papillary muscles located within the adjacent ventricle, comprising:
stopping the heart of the patient from beating;
resecting the heart wall of one of the atriums;
inserting a system for altering the geometry of a heart into the atrium, the system comprising a substantially rigid annuloplasty ring having an upper side and a lower side, an upper aperture located on the upper side and at least two lower apertures located on the lower side that are spaced apart from each other and at least one being spaced from the upper aperture around the annuloplasty ring, the annuloplasty ring further including channels that extend between the upper aperture and each of the lower apertures, the system further including at least two flexible, elongate annulus-papillary tension members that each extend from a second end through one of the lower apertures in the annuloplasty ring, through one of the channels, and through the upper aperture to a first end;
passing the second ends of the tension members into the ventricle associated with the atrium;
attaching each of the second ends of the tension members to a papillary muscle;
attaching the annuloplasty ring to the heart valve annulus between the atrium and the associated ventricle;
extending the first ends of the tension members from the upper aperture of the annuloplasty ring to a position outside the atrium; and
after restarting the heart of the patient and while the heart is beating, adjusting the distance between the second ends of the tension members and the annuloplasty ring by manipulating the first ends of the tension members from outside the atrium.
8. A method for adjusting, from outside the heart and while the heart is beating, the distance between a native heart valve annulus and associated papillary muscles located within the adjacent ventricle, comprising:
resecting the heart wall one of the atriums;
inserting a system for altering the geometry of a heart into the atrium, the system comprising a substantially rigid annuloplasty ring having an upper side and a lower side, an upper aperture located on the upper side and a lower aperture located on the lower side and spaced from the upper aperture around the annuloplasty ring, the annuloplasty ring further including channels that extend between the upper aperture and the lower aperture, the system further including a flexible, elongate annulus-papillary tension member that extends from a second end through the lower aperture in the annuloplasty ring, through one of the channels, and through the upper aperture to a first end;
passing the second end of the tension member into the ventricle associated with the atrium;
attaching the second end of the tension member to a papillary muscle;
extending a tool from outside the atrium through an opening in the wall of the atrium to the upper aperture;
sealing the opening in the wall of the atrium around the tool;
restarting the heart of the patient;
after restarting the heart of the patient and while the heart is beating, adjusting the distance between the second end of the tension member and the annuloplasty ring by manipulating the first end of the tension member; and
locking the position of the tension member through the upper aperture using the tool.
14. The method of claim 8, wherein the annuloplasty ring has two of the lower apertures located on the lower side that are spaced apart from each other, at least one being spaced from the upper aperture around the annuloplasty ring, and wherein there are two of the channels extending between the upper aperture and each of the two lower apertures, the system further including two of the flexible, elongate annulus-papillary tension members, and each tension member extends from a respective second end through one of the lower apertures in the annuloplasty ring, through one of the channels, and through the upper aperture to a respective first end, the method including:
after restarting the heart of the patient and while the heart is beating, adjusting the distance between the second ends of the two tension members and the annuloplasty ring by manipulating the first ends of the tension member; and
locking the positions of the two tension members through the upper aperture using the tool.
15. A method for adjusting, from outside the heart and while the heart is beating, the distance between a native heart valve annulus and associated papillary muscles located within the adjacent ventricle, comprising:
extending the first end of the tension member from the upper aperture of the annuloplasty ring to a position outside the atrium;
sealing the opening in the wall of the atrium around the tension member;
after restarting the heart of the patient and while the heart is beating, monitoring cardiac function and valve competence while adjusting the distance between the second end of the tension member and the annuloplasty ring by manipulating the first end of the tension member; and
locking the position of the tension member through the upper aperture.
21. The method of claim 15, wherein the annuloplasty ring has two of the lower apertures located on the lower side that are spaced apart from each other, at least one being spaced from the upper aperture around the annuloplasty ring, and wherein there are two of the channels extending between the upper aperture and each of the two lower apertures, the system further including two of the flexible, elongate annulus-papillary tension members, and each tension member extends from a respective second end through one of the lower apertures in the annuloplasty ring, through one of the channels, and through the upper aperture to a respective first end, the method including:
US13/396,498 2006-05-15 2012-02-14 Method for altering the geometry of the heart Active 2027-08-24 US8591576B2 (en)
US80938306P true 2006-05-31 2006-05-31
US30078609A true 2009-06-05 2009-06-05
US13/396,498 US8591576B2 (en) 2006-05-15 2012-02-14 Method for altering the geometry of the heart
US14/088,922 US9078752B2 (en) 2006-05-15 2013-11-25 Method for altering the geometry of the heart
US12300786 Continuation
PCT/DK2007/050058 Continuation WO2007131513A1 (en) 2006-05-15 2007-05-15 A system and a method for altering the geometry of the heart
US12/300,786 Continuation US8142495B2 (en) 2006-05-15 2007-05-15 System and a method for altering the geometry of the heart
US30078609A Continuation 2009-06-05 2009-06-05
US14/088,922 Continuation US9078752B2 (en) 2006-05-15 2013-11-25 Method for altering the geometry of the heart
US20120143323A1 US20120143323A1 (en) 2012-06-07
US8591576B2 true US8591576B2 (en) 2013-11-26
US12/300,786 Active US8142495B2 (en) 2006-05-15 2007-05-15 System and a method for altering the geometry of the heart
US13/396,498 Active 2027-08-24 US8591576B2 (en) 2006-05-15 2012-02-14 Method for altering the geometry of the heart
US14/088,922 Active US9078752B2 (en) 2006-05-15 2013-11-25 Method for altering the geometry of the heart
AT (1) AT499074T (en)
2007-05-15 DE DE602007012691T patent/DE602007012691D1/en active Active
2007-05-15 JP JP2009510283A patent/JP5258754B2/en active Active
2007-05-15 EP EP07722712A patent/EP2029053B1/en active Active
2007-05-15 WO PCT/DK2007/050058 patent/WO2007131513A1/en active Application Filing
2007-05-15 US US12/300,786 patent/US8142495B2/en active Active
2007-05-15 CA CA2677968A patent/CA2677968C/en active Active
2007-05-15 AT AT07722712T patent/AT499074T/en not_active IP Right Cessation
2007-05-15 CN CN2007800267010A patent/CN101489503B/en active IP Right Grant
2012-02-14 US US13/396,498 patent/US8591576B2/en active Active
2013-11-25 US US14/088,922 patent/US9078752B2/en active Active
Flachskampf, Frank A., et al. "Analysis of Shape and Motion of the Mitral Annulus in Subjects With and Without Cardiomyopathy by Echocardiographic 3-Dimensional Reconstruction," American Society of Echocardiography 0894-7317/2000, yr. 2000.
Watanabe, Nozomi, et al. "Mitral Annulus Flattens in Ischemic Mitral Regurgitation: Geometric Differences Between Inferior and Anterior Myocardial Infarction: A Real-Time 3-Dimensional Echocardiographic Study," American Heart Association .COPYRGT.2005; ISSN: 1524-4539.
US20120143323A1 (en) 2012-06-07
JP5258754B2 (en) 2013-08-07
DE602007012691D1 (en) 2011-04-07
EP2029053B1 (en) 2011-02-23
CN101489503A (en) 2009-07-22
US8142495B2 (en) 2012-03-27
US20140081393A1 (en) 2014-03-20
AT499074T (en) 2011-03-15
CN101489503B (en) 2012-01-11
CA2677968A1 (en) 2007-11-22
US9078752B2 (en) 2015-07-14
CA2677968C (en) 2014-07-08
JP2009537187A (en) 2009-10-29
WO2007131513A1 (en) 2007-11-22
US20100063586A1 (en) 2010-03-11
EP2029053A1 (en) 2009-03-04
Owner name: ENOVACOR APS, CALIFORNIA
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