Source: http://www.google.com/patents/US20030083538?ie=ISO-8859-1&dq=5179747
Timestamp: 2015-07-03 00:13:32
Document Index: 208707193

Matched Legal Cases: ['art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10', 'art 10']

DETAILED DESCRIPTION OF THE INVENTION [0045] Referring now to FIG. 1, it is a superior view of a human heart 10 with the atria removed to expose the mitral valve 12, the coronary sinus 14, the coronary artery 15, and the circumflex artery 17 of the heart 10 to lend a better understanding of the present invention. Also generally shown in FIG. 1 are the pulmonary valve 22, the aortic valve 24, and the tricuspid valve 26 of the heart 10. [0046] The mitral valve 12 includes an anterior cusp 16, a posterior cusp 18 and an annulus 20. The annulus encircles the cusps 16 and 18 and maintains their spacing to provide a complete closure during a left ventricular contraction. As is well known, the coronary sinus 14 partially encircles the mitral valve 12 adjacent to the mitral valve annulus 20. As is also known, the coronary sinus is part of the venus system of the heart and extends along the AV groove between the left atrium and the left ventricle. This places the coronary sinus essentially within the same plane as the mitral valve annulus making the coronary sinus available for placement of the mitral valve therapy device of the present invention therein. [0047] The circumflex artery 17 branches from the coronary artery 15 and supplies blood flow to critical tissue of the heart 10. The circumflex artery passes beneath the coronary sinus 14 at a crossover point 19. As will be seen hereinafter, the devices of the present invention avoid constriction of blood flow through the circumflex artery 17 when deployed in the coronary sinus 14. [0048]FIG. 2 shows a mitral valve therapy device 30 embodying the present invention. As may be noted in FIG. 2, the device 30 has an elongated base or first member 32 having an arched configuration to substantially continuously contact the pericardial wall 13 of the coronary sinus 14. As will be seen hereinafter, the base 32 forms an applied force distributor that distributes a force applied to the atrial wall 21 of the coronary sinus 14 and the adjacent mitral valve annulus 20 that reshapes the mitral valve annulus for terminating mitral regurgitation. To that end, the device includes a second member 34 which extends from the first member 32 at an angle 36. The second member 34 extends from the base 32 intermediate the ends 38 and 40 of the base. The second member contacts the atrial wall 21 of the coronary sinus 14 to apply an applied force to a localized discrete portion 23 thereof and a corresponding localized discrete portion 25 of the mitral valve annulus 20. Hence, the applied force as illustrated, reshapes the mitral valve annulus 20. [0049] The force applying second member 34 may take a configuration of a loop as shown or other configuration providing an end 42 which will apply the applied force without piercing or otherwise damaging the coronary sinus 14 or mitral valve annulus. The device 32 is preferably formed of a resilient biocompatible material. To that end, the device 32 may be formed of, for example, Nitinol, a nickel titanium alloy, well known in the art. This material, as is well known, is capable of being preformed but manipulated to be straight or partially bent while having sufficient memory to return to its preformed configuration. Stainless steel is also among the materials which may be used in forming the device 30. The first and second members 32 and 34 may be formed of the same material as an integral structure or may be formed of different materials. [0050] As will be noted in FIG. 2, the distal end 38 of the base 32 terminates proximally of the crossover point 19 of the circumflex artery 17 and coronary sinus 14. Hence, the device 32 avoids adversely effecting the blood supply provided by the circumflex artery. [0051] Referring now to FIG. 3, it illustrates another mitral valve device 50 embodying the present invention implanted in the coronary sinus 14 of the heart 10. The device 50 is formed from a single elongated member of material which may be any one of the materials previously referred to. The device 50 includes a pair of outwardly curved end portions 52 and 54 that substantially continuously engage the pericardial wall 13 of the coronary sinus 14. The end portions 52 and 54 thus form the force distributor of the device 50 that distributes an applied force along the pericardial wall 13 of the coronary sinus 14. The device 50 further includes an inwardly curved portion 56 between the outwardly curved end portions 52 and 54 to form the force applier. As will be noted in FIG. 3, the force applier 56 applies an applied force to a localized discrete portion 23 of the atrial wall 21 of the coronary sinus 14. This in turn applies the applied force to the corresponding localized discrete portion 25 of the mitral valve annulus 20. The foregoing results in the reshaping of the mitral valve annulus 20 for treating dilated cardiomyopathy. [0052] It may also be noted in FIG. 3 that the distal end 58 of the device 50 is proximal to the crossover point 19 of the circumflex artery 17 and the coronary sinus 14. Hence, in accordance with this embodiment, the blood supply of the circumflex artery is not effected by the device 50. [0053] Referring now to FIG. 4, it shows another mitral valve device 60 embodying the present invention implanted and deployed in the coronary sinus 14 of the heart 10. The device 60 takes the form of an expandable frame structure 62 which may be formed from Nitinol, for example. The device 60 may be first implanted in the coronary sinus 14 in a collapsed condition and then thereafter expanded to a deployed condition as illustrated. The device may be expanded by a balloon as known in the art, for example. [0054] Alternatively, the device 60 may be self-expanding. More particularly, the frame structure may be formed from Nitinol or other similar titanium based elastic material known in the art and heat treated as is known in the art while the device is in its expanded deployment condition. This sets the device. However, the device may then be collapsed and advanced into the coronary sinus with a catheter. After reaching a desired location within the coronary sinus, the collapsed device may be released from the catheter. Upon being released, the device will spring or self-expand to its expanded set and deployed condition. [0055] When deployed, the device 60 has a transverse cross-sectional dimension 64 greater than the unstressed cross-sectional dimension 66 of the coronary sinus 14. As a result, the device 60, when deployed, applies an applied force to a discrete portion 23 of the atrial wall 21 of the coronary sinus 14. This in turn applies the applied force to a discrete portion 25 of mitral valve annulus 20 to reshape the mitral valve annulus. [0056] As will be particularly noted in FIG. 4, and also applicable to all of the embodiments of the present invention disclosed herein, the force applier has an axial length substantially less than one-half the circumference of the mitral valve annulus 20. This differs greatly from prior art devices which attempt to reshape the mitral valve annulus by circumscribing essentially the entire length of the mitral valve annulus that lies along the coronary sinus. While such devices may be effective, their generalized mitral valve annulus reshaping is in sharp contrast to the localized discrete reshaping of the mitral valve annulus provided by the devices and method of the present invention. [0057]FIG. 5 shows another mitral valve device 70 embodying the present invention implanted in the coronary sinus 14 of the heart 10. The device 70 is an elongated frame structure 72. As will be noted in FIG. 5, the device 70 has a portion 74 of increased transverse dimension 76. The portion of increased transverse dimension 76 cause an applied force to be applied to a discrete portion 23 of the atrial wall of the coronary sinus 14. This in turn causes the applied force to be applied to a discrete portion 25 of the mitral valve annulus 20 to reshape the mitral valve annulus 20. [0058] The frame structure 72 is preferably expandable from a collapsed condition permitting the device 70 to be implanted to an expanded deployed condition as illustrated to apply the applied force. The frame structure 72 is preferably self-expanding as previously described or may be expanded by other means such as by mechanical expansion or balloon expansion. For self-expansion, the frame structure is preferably formed from Nitinol or another titanium based elastic material. For mechanical or balloon expansion, the frame structure 72 may be formed from stainless steel, for example. [0059]FIG. 6 is a perspective view of another mitral valve device 80 embodying the present invention. The device has an elongated semi-tubular base 82 having cut-out portions 84 to allow bending of the base 82. Between the cut-out portions 84 are semi-cylindrical surfaces 86 arranged to continuously contact the pericardial wall of the coronary sinus when the device 80 is implanted in the coronary sinus to distribute the applied force. [0060] The device 80 further includes a force applying member 88 which extends from opposed sidewalls 90 and 92 intermediate the ends of the base 82. The member 88 has an end 94 for engaging a discrete portion of the atrial wall of the coronary sinus to apply the applied force to a discrete portion of the mitral valve annulus to reshape the mitral valve annulus. [0061] The device 80 may be formed by laser cutting a Nitinol tube or from another suitable material. The member 88 may be set in the illustrated position by heat treating but capable of resiliently bending in line with the sidewalls 90 and 92 for implanting and thereafter self expand to return to the deployed condition shown. [0062]FIG. 7 is a perspective view of another mitral valve device 100 embodying the present invention which is similar to the device 80 of FIG. 6. The device 100 has an elongated semi-tubular base 102 having cut-out portions 104 to allow bending of the base 102. Between the cut-out portions 104 are semi-cylindrical surfaces 106 arranged to continuously contact the pericardial wall of the coronary sinus when the device 100 is implanted in the coronary sinus to distribute the applied force. [0063] The device 100 further includes a pair of force applying members 108 and 109 which extend substantially parallel to each other from opposed sidewalls 110 and 112 intermediate the ends of the base 102. The members 108 and 109 each have an end 114 and 116 for engaging the atrial wall of the coronary sinus to apply the applied force to a plurality of discrete portions of the atrial wall of the coronary sinus to in turn apply the applied force to corresponding discrete portions of the mitral valve annulus to reshape the mitral valve annulus. [0064] The device 100 may also be formed by laser cutting a Nitinol tube or from another suitable material. The members 108 and 109 may be set in the illustrated position by heat treating but capable of resiliently bending in line with the sidewalls 110 and 112 for implanting and to thereafter spring to the deployed condition as shown. [0065]FIG. 8 shows still another mitral valve device 120 embodying the present invention implanted in the coronary sinus 14 of the heart 10. Like the device 100 of FIG. 7, it applies an applied force to a plurality of discrete portions 23 of the atrial wall of the coronary sinus 14 to in turn apply the force to a corresponding plurality of discrete portions 25 of the mitral valve annulus 20 to reshape the mitral valve annulus 20. [0066] The device 120 takes the form of a frame structure 122 having an elongated base 124 that makes substantially continuous contact with the pericardial wall 13 of the coronary sinus 14. [0067] The base 124 is semi-tubular. Extending from the base 124 are integral columnar structures 126 and 128. The columnar structures 126 and 128 form the force applier to apply the applied force to the plurality of discrete portions of the atrial wall of the coronary sinus. [0068] The frame structure, like the other frame structures described herein, is expandable from a collapsed condition to permit implanting of the device to an expanded condition, once implanted, as shown. To that end, the frame structure 122 may be expanded by balloon expansion, mechanical expansion, or self expansion. When deployed as illustrated, the base 124 has a greater surface area than the columnar structures 126 and 128 to distribute the applied force along the pericardial wall 13 of the coronary sinus 14. [0069]FIG. 9 shows how the device 120 of FIG. 8 may be expanded with a balloon from its collapsed condition to its expanded condition. Here it may be seen that a balloon 130 is inserted into the device 120. Thereafter, the balloon 130 is inflated. As the balloon 130 inflates, it forces the frame structure 122 to expand to its expanded condition to form the deployed base 124 and then deployed columnar structures 126 and 128. [0070]FIGS. 10 and 11 show a still further device 140 embodying the present invention and which may be mechanically expanded to a deployed condition. As best seen in FIG. 10, the device 140, when in the collapsed condition, takes the form of a hollow cylinder 142 having slits 144 along its axial length. Extending through the hollow cylinder 142 is a pull wire 146. The pull wire terminates in an enlarged end 148. [0071] As best seen in FIG. 11, when the collapsed device is positioned in the coronary sinus for deployment, the pull wire 136 is pulled proximally while the hollow cylinder 142 is held stationary against a grip spring 150. This causes the hollow cylinder to bend along the slits 144 like a toggle bolt to form a plurality of blades 152. The blades then form a force applier which apply a force to a discrete portion of the coronary sinus to reshape the mitral valve annulus. [0072]FIG. 12 shows a still further device 160 embodying the present invention. Here the device is expandable as it takes the form of a balloon 162. The balloon, when inflated to a deployed condition has a hollow core 164 to permit blood flow through the coronary sinus. By being inflated, the device 160 is expanded for applying a force to a discrete portion of the coronary sinus to reshape the mitral valve annulus. [0073] The balloon 162 is inflated by a balloon catheter 166 which carries the balloon 162. The balloon, when deflated, and the catheter 166 are guided into position within the coronary sinus by a guide wire 168 upon which the catheter 166 is mounted. When the balloon is positioned within the coronary sinus as desired, the balloon is inflated by the introduction of a fluid or gas into an inflation port 170 of the balloon catheter 166 for applying an applied force to a discrete portion of the mitral valve annulus. The device of FIG. 12 is particularly well suited for temporary use, for example, to measure the effectiveness of a device in various positions or of various sizes. [0074] As may be seen from the foregoing, the present invention provides a mitral valve device and method for reshaping the mitral valve annulus to treat dilated cardiomyopathy. The devices apply an applied force to one or more desirable discrete portions of the atrial wall of the coronary sinus to reshape the adjacent mitral valve annulus in a localized, as opposed to a generalized, manner. Further, all of the embodiments disclosed herein avoid the crossover point of the circumflex artery and the coronary sinus. [0075] While particular embodiments of the present invention have been shown and described, modifications may be made, and it is therefore intended in the appended claims to cover all such changes and modifications which fall within the true spirit and scope of the invention. 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Lifesciences AgMethod and device for treatment of mitral insufficiencyUS8211171 *Nov 13, 2007Jul 3, 2012The United States Of America, As Represented By The Secretary Of The Department Of Health And Human ServicesTranscatheter coronary sinus mitral valve annuloplasty procedure and coronary artery and myocardial protection deviceUS8475524Aug 1, 2005Jul 2, 2013Biosense Webster, Inc.Monitoring of percutaneous mitral valvuloplastyUS8709074Feb 6, 2012Apr 29, 2014Edwards Lifesciences AgMethod and device for treatment of mitral insufficiencyUS8764626Jan 24, 2012Jul 1, 2014Edwards Lifesciences CorporationMethod of treating a dilated ventricleUS8798742Mar 31, 2009Aug 5, 2014Cardiac Pacemakers, Inc.Method and apparatus for adjusting cardiac event detection threshold based on dynamic noise estimationUS8979923 *Sep 24, 2004Mar 17, 2015Mitralign, Inc.Tissue fastening systems and methods utilizing magnetic guidanceUS9011531Feb 13, 2013Apr 21, 2015Mitraspan, Inc.Method and apparatus for repairing a mitral valveUS20100049314 *Nov 13, 2007Feb 25, 2010June-Hong KimTranscatheter coronary sinus mitral valve annuloplasty procedure and coronary artery and myocardial protection deviceEP1749475A2Jul 31, 2006Feb 7, 2007Biosense Webster, Inc.Monitoring of percutaneous mitral valvuloplastyWO2004047677A2 *Nov 24, 2003Jun 10, 2004Ev3 Santa Rosa IncMethods and apparatus for remodeling an extravascular tissue structureWO2005058206A1Dec 16, 2004Jun 30, 2005Edwards Lifesciences AgDevice for changing the shape of the mitral annulus* Cited by examinerClassifications U.S. Classification600/16International ClassificationA61F2/958, A61F2/24Cooperative ClassificationA61F2/2451, A61M25/1006European ClassificationA61F2/24R4Legal EventsDateCodeEventDescriptionNov 1, 2001ASAssignmentOwner name: CARDIAC DIMENSIONS, INC., WASHINGTONFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ADAMS, JOHN M,;REUTER, DAVID G.;MATHIS, MARK L.;AND OTHERS;REEL/FRAME:012358/0635Effective date: 20011031Feb 25, 2009FPAYFee paymentYear of fee payment: 4Feb 27, 2013FPAYFee paymentYear of fee payment: 8Apr 24, 2014ASAssignmentFree format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNOR:CARDIAC DIMENSIONS, INC.;REEL/FRAME:032759/0069Effective date: 20140411Owner name: CARDIAC DIMENSIONS PTY. 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