US20060195012A1 - Valve to myocardium tension members device and method - Google Patents
Valve to myocardium tension members device and methodDownload PDFInfo
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- US20060195012A1 US20060195012A1US11/403,859US40385906AUS2006195012A1US 20060195012 A1US20060195012 A1US 20060195012A1US 40385906 AUS40385906 AUS 40385906AUS 2006195012 A1US2006195012 A1US 2006195012A1
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Images
Classifications
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2478—Passive devices for improving the function of the heart muscle, i.e. devices for reshaping the external surface of the heart, e.g. bags, strips or bands
- A61F2/2487—Devices within the heart chamber, e.g. splints
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2454—Means for preventing inversion of the valve leaflets, e.g. chordae tendineae prostheses
- A61F2/2457—Chordae tendineae prostheses
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
- A61B17/00—Surgical instruments, devices or methods
- A61B17/04—Surgical instruments, devices or methods for suturing wounds; Holders or packages for needles or suture materials
- A61B17/0469—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery
- A61B2017/048—Suturing instruments for use in minimally invasive surgery, e.g. endoscopic surgery for reducing heart wall tension, e.g. sutures with a pad on each extremity
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2445—Annuloplasty rings in direct contact with the valve annulus
- A—HUMAN NECESSITIES
- A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
- A61F—FILTERS IMPLANTABLE INTO BLOOD VESSELS; PROSTHESES; DEVICES PROVIDING PATENCY TO, OR PREVENTING COLLAPSING OF, TUBULAR STRUCTURES OF THE BODY, e.g. STENTS; ORTHOPAEDIC, NURSING OR CONTRACEPTIVE DEVICES; FOMENTATION; TREATMENT OR PROTECTION OF EYES OR EARS; BANDAGES, DRESSINGS OR ABSORBENT PADS; FIRST-AID KITS
- A61F2/00—Filters implantable into blood vessels; Prostheses, i.e. artificial substitutes or replacements for parts of the body; Appliances for connecting them with the body; Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/02—Prostheses implantable into the body
- A61F2/24—Heart valves ; Vascular valves, e.g. venous valves; Heart implants, e.g. passive devices for improving the function of the native valve or the heart muscle; Transmyocardial revascularisation [TMR] devices; Valves implantable in the body
- A61F2/2442—Annuloplasty rings or inserts for correcting the valve shape; Implants for improving the function of a native heart valve
- A61F2/2463—Implants forming part of the valve leaflets
- Y—GENERAL TAGGING OF NEW TECHNOLOGICAL DEVELOPMENTS; GENERAL TAGGING OF CROSS-SECTIONAL TECHNOLOGIES SPANNING OVER SEVERAL SECTIONS OF THE IPC; TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10—TECHNICAL SUBJECTS COVERED BY FORMER USPC
- Y10S—TECHNICAL SUBJECTS COVERED BY FORMER USPC CROSS-REFERENCE ART COLLECTIONS [XRACs] AND DIGESTS
- Y10S623/00—Prosthesis, i.e. artificial body members, parts thereof, or aids and accessories therefor
- Y10S623/90—Stent for heart valve
Definitions
- the present inventionpertains generally to the field of heart valve repair. More specifically, the present invention pertains to a device and method for the reduction of myocardial wall tension and the repair of mitral valve insufficiency.
- Dilated cardiomyopathyis often accompanied by mitral valve insufficiency.
- mitral valve insufficiencyThere are several reasons for the presence of mitral valve insufficiency associated with a dilated heart.
- chamber dilation and associated high wall stressesincrease the diameter of the mitral valve annulus.
- the positioning of the papillary musclesis altered. Papillary muscles and chordae in a dilated heart will have moved both radially away and down from the mitral valve. This rearrangement of the vascular apparatus and enlargement of the annulus prevent the valve from closing properly.
- mitral valve insufficiencyis treated by either repairing or replacing the valve.
- Surgical procedures used to repair the valveincluding ring posterior annuloplasty which consists of sewing a C or D-shaped ring around the posterior leaf let of the mitral valve and drawing in the annulus, reducing its previously enlarged diameter.
- Another methodis to approximate the anterior and posterior mitral leaflets (Alfieri repair) by placing one suture through the center of both leaflets. This gives the valve a figure 8-shaped appearance when the valve is opened.
- An artificial valveconsists of mechanical or tissue leaflets suspended on struts attached to a metal stent, and is sutured into place on the mitral annulus.
- valve repairis preferable to valve replacement if the leaflet-chordae-papillary connections can be maintained.
- Heart wall stresswill increase if the chordae are cut during valve replacement. It has been shown that by severing the chordae there can be 30 percent (30%) reduction in chamber function. Mitral valve replacement has high morality in very sick, chronic heart failure patients.
- the present inventionpertains to a device and method for mitral valve repair.
- the mitral-valveis generally defined as its leaflets or cusps, but in reality, it actually consists of the entire left ventricle chamber. By creating an improved chamber geometry, both chamber and valve function will be improved.
- the device of the present invention and method for valve repair/replacementcan include treatment for chronic heart failure by reducing left ventricular wall tension.
- the valve repair deviceincludes an elongate tension member having a first end and second end.
- the basal anchoris disposed at the first end and the secondary anchor is disposed at the second end.
- the basal anchorcould include a pad and annuloplasty ring or the like. Alternately an artificial heart valve could serve as the basal anchor.
- Tension memberscan be substantially rigid or substantially flexible.
- the secondary anchorcan include a hook-shaped papillary muscle tissue loop, screw-shaped tissue anchor or transmural anchor pad.
- the method of the present inventionproviding a tension member having a first end and a second end.
- the tension memberhas a basal anchor at the first end and a secondary anchor at the second end.
- the basal anchoris anchored proximate to the valve such that the tension member is disposed in the chamber.
- the secondary anchoris anchored to a portion of the heart spaced from the basal anchor such that the tension member is under tension and the geometry of the chamber has been altered by placement of the tension member.
- the basal anchorcan include an artificial heart valve, annuloplasty ring or the like.
- the secondary anchorcan be anchored to a papillary muscle or transmurally anchored.
- More than one tension membercan be used. Additionally, a transverse tension member can be placed across the chamber generally perpendicular to the other tension members to further alter the geometry of the heart, reducing wall stress and improving chamber performance.
- FIG. 1is a transverse cross section of the left ventricle of a human heart taken from FIG. 2 ;
- FIG. 2is a vertical cross section of the left ventricle of a human heart
- FIG. 3is a modified, transverse, cross section of the left ventricle of a human heart taken from FIG. 4 ;
- FIG. 4is modified, vertical cross section of a human heart, modified by a device in accordance with the present invention
- FIG. 5is a cross section of an insufficient mitral valve of a left ventricle of a human heart
- FIG. 6is a cross section of a repaired valve and device in accordance with the present invention.
- FIG. 7is an embodiment of the device of the present invention.
- FIG. 8is an alternate embodiment of a device in accordance with the present invention.
- FIG. 9is yet another alternate embodiment of a device in accordance with the present invention.
- FIG. 10is yet another alternate embodiment of the device in accordance with the present invention.
- FIG. 11is yet another alternate embodiment of a device in accordance with the present invention.
- FIG. 12is a view of a basal anchor for the device of the present invention.
- FIG. 13is a suture ring serving as a basal anchor for the device of the present invention.
- FIG. 14is a replacement valve serving as a anchor for the device of the present invention.
- FIG. 15is a top view of an alternate embodiment of a suture ring acting as an anchor for the device of the present invention.
- FIG. 16is a side view of the suture ring of FIG. 15 ;
- FIG. 17is a view of an alternate embodiment of a suture ring which can act as basal anchor for the device of the present invention.
- FIG. 18is a view of yet another alternate embodiment of a suture ring which can act as a basal anchor for the present invention.
- FIG. 19is a embodiment of a secondary anchor for the device of the present invention.
- FIG. 20is a view of an alternate embodiment of a secondary anchor for the device of the present invention.
- FIG. 21is yet another embodiment of a secondary anchor for the device of the present invention.
- FIG. 1shows a transverse cross section of the left ventricle 10 of a failing heart taken from FIG. 2 .
- the papillary muscles 12are shown in cross section.
- FIG. 2is a vertical cross section of human heart 10 .
- a mitral valveis disposed near the top of left ventricle 10 .
- Mitral valve 14includes two leaflets or cusps 16 .
- Chordae 18extend between leaflets 16 and papillary muscles 12 .
- FIG. 3is a cross section of heart 10 modified from that shown in FIG. 1 by placement of valve repair device 20 in accordance with the present invention as shown in FIG. 4 .
- FIG. 4is a vertical cross section of left ventricle 10 with geometry modified by device 20 .
- device 20includes a basal anchor 22 such as an annuloplasty or suture ring sewn proximate the annulus of valve 14 .
- basal anchor 22such as an annuloplasty or suture ring sewn proximate the annulus of valve 14 .
- elongate tension members 24Extending from basal anchor 22 are elongate tension members 24 . Each have a first end connected to basal anchor 22 and a second end anchored to papillary muscles 12 or the heart wall.
- both the transverse radius and vertical dimension of left ventricle 10has been reduced in comparison to that of FIGS. 1 and 2 by drawing papillary muscles 12 toward valve 14 with tension members 24 .
- This change in geometryreduces heart wall stress and consequently increasing chamber function.
- Valve functionis also improved as explained in more detail by reference to FIGS. 5 and 6 .
- FIG. 5is a generally vertical cross section of an insufficient mitral valve of a heart suffering from chronic heart failure.
- papillary muscle 12has been drawn away from mitral valve 14 .
- the chordae connections between papillary muscles 12 and valve 14in turn draws leaflets 16 apart such that during the normal cardiac cycle, leaflets 16 may not completely close.
- an opening 26is left between leaflets 16 throughout the cardiac cycle. Opening 26 will allow blood to leak, reducing chamber efficiency.
- FIG. 6is a view of the mitral valve 14 of FIG. 5 which has been modified by placement of valve repair device 20 as shown.
- Suture ring 22is sewn proximate the annulus of valve 14 , as known to those skilled in the use of suture rings.
- the annulus of valve 14can be decreased in size by drawing the annulus toward the suture ring by the sutures used to connect ring 22 to the valve. Drawing the annulus of valve 14 toward suture ring 22 will help to eliminate opening 26 .
- Tension member 24is then anchored to papillary muscle 12 such that papillary muscle 12 is drawn toward valve 14 .
- drawing papillary muscle 12 toward valve 14will provide additional stress relief on leaflet 16 promoting complete closure of valve 14 .
- Drawing papillary muscle 12 toward 14also reduces heart wall stress and increases chamber efficiency as discussed previously.
- FIG. 7is a highly simplified view of left ventricle 10 and valve repair device 20 as shown in FIG. 4 . It can be noted that tension members 24 extend from basal anchor 22 to an adjacent papillary muscle 12 .
- FIG. 8is a similar cross sectional view of left ventricle 10 , but a valve repair device 120 is placed such that its tension members 124 extend between a basal anchor 122 and a papillary muscle 12 transversely opposite the point at which tension member 124 is connected to basal anchor 122 .
- This arrangementas opposed to that shown in FIG. 7 , can increase the transverse component of the tension force in tension members 124 relative to the vertical component of that tensile force.
- FIG. 9shows yet another embodiment of the valve repair device in accordance with the present invention referred to by numeral 220 .
- device 220is disposed in left ventricle 10 in a manner similar to that of device 20 shown in FIG. 7 in that tension members 224 of device 220 extend from a basal anchor 222 to an adjacent secondary anchor point.
- the secondary anchor pointis established by transverse extension of a tension member 225 across left ventricle 10 .
- Tension member 225is anchored transmurally to the heart wall at its opposite ends by pads 227 .
- tension members 224are anchored or connected to tension member 225 .
- Tension member 225can be used to further alter the geometry of left ventricle 10 in a manner disclosed in U.S. patent application Ser. No. 08/933,456, entitled “HEART WALL TENSION REDUCTION APPARATUS AND METHOD”, which was filed on Sep. 18, 1997 and is incorporated herein by reference.
- FIG. 10shows yet another embodiment of a valve repair device in accordance with the present invention referred to by numeral 320 .
- This embodimentincludes a basal anchor 322 and tension members 324 and a transverse tension member 325 having anchor pads 327 similar to those of device 220 .
- tension members 324are crossed similar to those of device 120 of FIG. 8 to increase the horizontal component relative to the vertical component of the tensile force in tension member 324 .
- FIG. 11is a yet another embodiment 420 of the valve repair device of the present method.
- Valve repair device 420includes a basal anchor 422 and tension members 424 .
- Tension members 424are disposed in an arrangement similar to tension members 24 of device 20 shown in FIG. 7 except that tension members 424 are anchored transmurally by pads 427 rather than into papillary muscles 12 .
- the relatively greater thickness of tension members 424 shown in FIG. 11as compared to tension members 24 shown in FIG. 7 , merely illustrates that the tension members can be substantially rigid or in the case of tension members 24 , substantially flexible. It should be understood, however, that in any of the embodiments shown herein, the tension members could be advantageously formed to be substantially flexible or substantially rigid.
- FIG. 12is a top or posterior view of valve 14 .
- the basal anchor for the valve repair deviceis shown as discrete pads 28 which can be sewn to the posterior side of valve 14 .
- Tension members 24are shown extending from respective pads 28 into the left ventricle.
- FIG. 13is the same view of valve 14 as FIG. 12 .
- the basal anchor 22is shown as a crescent-shaped suture ring.
- Tension members 24extends from basal anchor 22 through valve 14 into the left ventricle.
- FIG. 14is a side view of an artificial heart valve 30 . If it is necessary to replace the valve rather than merely repair it, artificial valve 30 can be used as a basal anchor for tension members 24 .
- FIG. 15is a top view of an alternate embodiment of a suture ring basal anchor 32 .
- Ring 32has a crescent shape and a pylon 34 extending through the mitral valve.
- FIG. 16is a side view of suture ring 32 showing tension members 24 attached to pylon 34 .
- Tension members 24preferably extend through the tissue of valve 14 rather than through the valve opening. It can be appreciated, however, that tension members 24 could be disposed through the valve opening. In the case of the embodiment of FIGS. 15 and 16 , however, pylon 34 would be disposed through the valve opening. Tension members 24 associated with pylon 34 would be disposed on the opposite side of valve 14 from suture ring 32 . Pylon 34 would preferably be disposed through the valve opening rather than the tissue forming valve 14 .
- FIGS. 17 and 18are yet additional alternate embodiments of suture rings which can be used as basal anchors in accordance with the present invention.
- the shape of the ringsis selected such that as they are sewn into place on valve 14 , the sutures can be used to draw tissue toward the inside of the ring, thus reducing the transverse and/or vertical cross sectional area of the associated heart chamber. This will advantageously reduce heart wall stress which is of particular benefit if the patient has a failing heart.
- tension members 24can be fixably or releasably attached to the basal anchor.
- the tension membersare fixably attached to the basal anchor during the valve repair procedure.
- FIGS. 19-21show various configurations of anchoring devices shown at the second end of tension member 24 . It can be appreciated that these anchoring devices could be used with each of the tension members described above.
- the second end of tension member 24includes a secondary anchor 40 formed as screw which is shown augured into papillary muscle 12 .
- FIG. 20shows a secondary anchor 42 including a loop sewn through papillary muscle 12 .
- FIG. 21shows a tension member 24 extending transmurally to an exterior pad 44 to which it is connected. Tension member 24 could be sewn to pad 44 or otherwise mechanically connected thereto.
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Abstract
Description
- The present invention pertains generally to the field of heart valve repair. More specifically, the present invention pertains to a device and method for the reduction of myocardial wall tension and the repair of mitral valve insufficiency.
- Dilated cardiomyopathy is often accompanied by mitral valve insufficiency. There are several reasons for the presence of mitral valve insufficiency associated with a dilated heart. First, chamber dilation and associated high wall stresses increase the diameter of the mitral valve annulus. Additionally, as the heart dilates, the positioning of the papillary muscles is altered. Papillary muscles and chordae in a dilated heart will have moved both radially away and down from the mitral valve. This rearrangement of the vascular apparatus and enlargement of the annulus prevent the valve from closing properly.
- Currently mitral valve insufficiency is treated by either repairing or replacing the valve. Surgical procedures used to repair the valve including ring posterior annuloplasty which consists of sewing a C or D-shaped ring around the posterior leaf let of the mitral valve and drawing in the annulus, reducing its previously enlarged diameter. Another method is to approximate the anterior and posterior mitral leaflets (Alfieri repair) by placing one suture through the center of both leaflets. This gives the valve a figure 8-shaped appearance when the valve is opened. When the mitral valve is replaced, the original leaflets are removed and the chordae are cut. An artificial valve consists of mechanical or tissue leaflets suspended on struts attached to a metal stent, and is sutured into place on the mitral annulus.
- It has been argued that valve repair is preferable to valve replacement if the leaflet-chordae-papillary connections can be maintained. Heart wall stress will increase if the chordae are cut during valve replacement. It has been shown that by severing the chordae there can be 30 percent (30%) reduction in chamber function. Mitral valve replacement has high morality in very sick, chronic heart failure patients.
- The present invention pertains to a device and method for mitral valve repair. The mitral-valve is generally defined as its leaflets or cusps, but in reality, it actually consists of the entire left ventricle chamber. By creating an improved chamber geometry, both chamber and valve function will be improved. The device of the present invention and method for valve repair/replacement can include treatment for chronic heart failure by reducing left ventricular wall tension.
- In one embodiment of the present invention, the valve repair device includes an elongate tension member having a first end and second end. The basal anchor is disposed at the first end and the secondary anchor is disposed at the second end.
- The basal anchor could include a pad and annuloplasty ring or the like. Alternately an artificial heart valve could serve as the basal anchor.
- Tension members can be substantially rigid or substantially flexible. The secondary anchor can include a hook-shaped papillary muscle tissue loop, screw-shaped tissue anchor or transmural anchor pad.
- The method of the present invention providing a tension member having a first end and a second end. The tension member has a basal anchor at the first end and a secondary anchor at the second end. The basal anchor is anchored proximate to the valve such that the tension member is disposed in the chamber. The secondary anchor is anchored to a portion of the heart spaced from the basal anchor such that the tension member is under tension and the geometry of the chamber has been altered by placement of the tension member.
- The basal anchor can include an artificial heart valve, annuloplasty ring or the like. The secondary anchor can be anchored to a papillary muscle or transmurally anchored.
- More than one tension member can be used. Additionally, a transverse tension member can be placed across the chamber generally perpendicular to the other tension members to further alter the geometry of the heart, reducing wall stress and improving chamber performance.
FIG. 1 is a transverse cross section of the left ventricle of a human heart taken fromFIG. 2 ;FIG. 2 is a vertical cross section of the left ventricle of a human heart;FIG. 3 is a modified, transverse, cross section of the left ventricle of a human heart taken fromFIG. 4 ;FIG. 4 is modified, vertical cross section of a human heart, modified by a device in accordance with the present invention;FIG. 5 is a cross section of an insufficient mitral valve of a left ventricle of a human heart;FIG. 6 is a cross section of a repaired valve and device in accordance with the present invention;FIG. 7 is an embodiment of the device of the present invention;FIG. 8 is an alternate embodiment of a device in accordance with the present invention;FIG. 9 is yet another alternate embodiment of a device in accordance with the present invention;FIG. 10 is yet another alternate embodiment of the device in accordance with the present invention;FIG. 11 is yet another alternate embodiment of a device in accordance with the present invention;FIG. 12 is a view of a basal anchor for the device of the present invention;FIG. 13 is a suture ring serving as a basal anchor for the device of the present invention;FIG. 14 is a replacement valve serving as a anchor for the device of the present invention;FIG. 15 is a top view of an alternate embodiment of a suture ring acting as an anchor for the device of the present invention;FIG. 16 is a side view of the suture ring ofFIG. 15 ;FIG. 17 is a view of an alternate embodiment of a suture ring which can act as basal anchor for the device of the present invention;FIG. 18 is a view of yet another alternate embodiment of a suture ring which can act as a basal anchor for the present invention;FIG. 19 is a embodiment of a secondary anchor for the device of the present invention;FIG. 20 is a view of an alternate embodiment of a secondary anchor for the device of the present invention; andFIG. 21 is yet another embodiment of a secondary anchor for the device of the present invention.- Referring now the drawings wherein like reference numerals refer to like elements throughout the several views,
FIG. 1 shows a transverse cross section of theleft ventricle 10 of a failing heart taken fromFIG. 2 . Thepapillary muscles 12 are shown in cross section.FIG. 2 is a vertical cross section ofhuman heart 10. A mitral valve is disposed near the top ofleft ventricle 10.Mitral valve 14 includes two leaflets orcusps 16.Chordae 18 extend betweenleaflets 16 andpapillary muscles 12. FIG. 3 is a cross section ofheart 10 modified from that shown inFIG. 1 by placement ofvalve repair device 20 in accordance with the present invention as shown inFIG. 4 .FIG. 4 is a vertical cross section ofleft ventricle 10 with geometry modified bydevice 20. In this embodiment of the invention,device 20 includes abasal anchor 22 such as an annuloplasty or suture ring sewn proximate the annulus ofvalve 14. Extending frombasal anchor 22 areelongate tension members 24. Each have a first end connected tobasal anchor 22 and a second end anchored topapillary muscles 12 or the heart wall.- As can be seen in
FIGS. 3 and 4 , both the transverse radius and vertical dimension ofleft ventricle 10 has been reduced in comparison to that ofFIGS. 1 and 2 by drawingpapillary muscles 12 towardvalve 14 withtension members 24. This change in geometry reduces heart wall stress and consequently increasing chamber function. Valve function is also improved as explained in more detail by reference toFIGS. 5 and 6 . FIG. 5 is a generally vertical cross section of an insufficient mitral valve of a heart suffering from chronic heart failure. In this case as the failing heart has dilated,papillary muscle 12 has been drawn away frommitral valve 14. The chordae connections betweenpapillary muscles 12 andvalve 14 in turn drawsleaflets 16 apart such that during the normal cardiac cycle,leaflets 16 may not completely close. Thus, anopening 26 is left betweenleaflets 16 throughout the cardiac cycle.Opening 26 will allow blood to leak, reducing chamber efficiency.FIG. 6 is a view of themitral valve 14 ofFIG. 5 which has been modified by placement ofvalve repair device 20 as shown.Suture ring 22 is sewn proximate the annulus ofvalve 14, as known to those skilled in the use of suture rings. The annulus ofvalve 14 can be decreased in size by drawing the annulus toward the suture ring by the sutures used to connectring 22 to the valve. Drawing the annulus ofvalve 14 towardsuture ring 22 will help to eliminateopening 26.Tension member 24 is then anchored topapillary muscle 12 such thatpapillary muscle 12 is drawn towardvalve 14. Whether or not the suture ring alone is sufficient to eliminateopening 26, drawingpapillary muscle 12 towardvalve 14 will provide additional stress relief onleaflet 16 promoting complete closure ofvalve 14. Drawingpapillary muscle 12 toward14 also reduces heart wall stress and increases chamber efficiency as discussed previously.FIG. 7 is a highly simplified view ofleft ventricle 10 andvalve repair device 20 as shown inFIG. 4 . It can be noted thattension members 24 extend frombasal anchor 22 to an adjacentpapillary muscle 12. In contrast,FIG. 8 is a similar cross sectional view ofleft ventricle 10, but avalve repair device 120 is placed such that itstension members 124 extend between abasal anchor 122 and apapillary muscle 12 transversely opposite the point at whichtension member 124 is connected tobasal anchor 122. This arrangement, as opposed to that shown inFIG. 7 , can increase the transverse component of the tension force intension members 124 relative to the vertical component of that tensile force.FIG. 9 shows yet another embodiment of the valve repair device in accordance with the present invention referred to bynumeral 220. In this embodiment,device 220 is disposed inleft ventricle 10 in a manner similar to that ofdevice 20 shown inFIG. 7 in thattension members 224 ofdevice 220 extend from abasal anchor 222 to an adjacent secondary anchor point. The secondary anchor point is established by transverse extension of atension member 225 acrossleft ventricle 10.Tension member 225 is anchored transmurally to the heart wall at its opposite ends bypads 227. In turn,tension members 224 are anchored or connected totension member 225.Tension member 225 can be used to further alter the geometry ofleft ventricle 10 in a manner disclosed in U.S. patent application Ser. No. 08/933,456, entitled “HEART WALL TENSION REDUCTION APPARATUS AND METHOD”, which was filed on Sep. 18, 1997 and is incorporated herein by reference.FIG. 10 shows yet another embodiment of a valve repair device in accordance with the present invention referred to bynumeral 320. This embodiment includes abasal anchor 322 andtension members 324 and atransverse tension member 325 havinganchor pads 327 similar to those ofdevice 220. With respect todevice 320, however,tension members 324 are crossed similar to those ofdevice 120 ofFIG. 8 to increase the horizontal component relative to the vertical component of the tensile force intension member 324.FIG. 11 is a yet anotherembodiment 420 of the valve repair device of the present method.Valve repair device 420 includes abasal anchor 422 andtension members 424.Tension members 424 are disposed in an arrangement similar totension members 24 ofdevice 20 shown inFIG. 7 except thattension members 424 are anchored transmurally bypads 427 rather than intopapillary muscles 12. The relatively greater thickness oftension members 424 shown inFIG. 11 , as compared totension members 24 shown inFIG. 7 , merely illustrates that the tension members can be substantially rigid or in the case oftension members 24, substantially flexible. It should be understood, however, that in any of the embodiments shown herein, the tension members could be advantageously formed to be substantially flexible or substantially rigid.FIG. 12 is a top or posterior view ofvalve 14. In this embodiment, the basal anchor for the valve repair device is shown asdiscrete pads 28 which can be sewn to the posterior side ofvalve 14.Tension members 24 are shown extending fromrespective pads 28 into the left ventricle.FIG. 13 is the same view ofvalve 14 asFIG. 12 . InFIG. 13 , however, thebasal anchor 22 is shown as a crescent-shaped suture ring.Tension members 24 extends frombasal anchor 22 throughvalve 14 into the left ventricle.FIG. 14 is a side view of anartificial heart valve 30. If it is necessary to replace the valve rather than merely repair it,artificial valve 30 can be used as a basal anchor fortension members 24.FIG. 15 is a top view of an alternate embodiment of a suture ringbasal anchor 32.Ring 32 has a crescent shape and apylon 34 extending through the mitral valve.FIG. 16 is a side view ofsuture ring 32 showingtension members 24 attached topylon 34.Tension members 24 preferably extend through the tissue ofvalve 14 rather than through the valve opening. It can be appreciated, however, thattension members 24 could be disposed through the valve opening. In the case of the embodiment ofFIGS. 15 and 16 , however, pylon34 would be disposed through the valve opening.Tension members 24 associated withpylon 34 would be disposed on the opposite side ofvalve 14 fromsuture ring 32.Pylon 34 would preferably be disposed through the valve opening rather than thetissue forming valve 14.FIGS. 17 and 18 are yet additional alternate embodiments of suture rings which can be used as basal anchors in accordance with the present invention. The shape of the rings is selected such that as they are sewn into place onvalve 14, the sutures can be used to draw tissue toward the inside of the ring, thus reducing the transverse and/or vertical cross sectional area of the associated heart chamber. This will advantageously reduce heart wall stress which is of particular benefit if the patient has a failing heart.- It can be appreciated that
tension members 24 can be fixably or releasably attached to the basal anchor. Preferably, the tension members are fixably attached to the basal anchor during the valve repair procedure. FIGS. 19-21 show various configurations of anchoring devices shown at the second end oftension member 24. It can be appreciated that these anchoring devices could be used with each of the tension members described above. InFIG. 19 , the second end oftension member 24 includes asecondary anchor 40 formed as screw which is shown augured intopapillary muscle 12.FIG. 20 shows a secondary anchor42 including a loop sewn throughpapillary muscle 12.FIG. 21 shows atension member 24 extending transmurally to anexterior pad 44 to which it is connected.Tension member 24 could be sewn to pad44 or otherwise mechanically connected thereto.- It can be appreciated that various biocompatible materials can be advantageously used to form the various components of the device of the present invention. It is anticipated that the present device will usually be chronically implanted. Thus, when selecting materials to form each of the components consideration should be given to the consequences of long term exposure of the device to tissue and tissue to the device.
- Numerous characteristics and advantages of the invention covered by this document have been set forth in the foregoing description. It will be understood, however, that this disclosure is, in many respects, only illustrative. Charges may be made in details, particularly in matters of shape, size, and arrangement of parts without exceeding the scope of the invention. The inventions's scope is, of course, defined in the language in which the appended claims are expressed.
Claims (23)
1-17. (canceled)
18. A method of treating mitral valvular regurgitation in a human heart, the method comprising:
providing a self-anchoring mechanical device;
identifying a target region of a myocardium of the heart; and
positioning the self-anchoring mechanical device within a portion of the identified target region so as to adjust a position of a base of at least one papillary muscle coupled to a mitral valve.
19. The method ofclaim 18 , wherein the position is adjusted by decreasing distension of the base.
20. The method ofclaim 18 , wherein the self-anchoring mechanical device comprises a longitudinal axis, the method further comprising:
positioning the longitudinal axis substantially parallel to the endocardial surface in an apex-to-base direction.
21. The method ofclaim 18 , wherein the target region comprises the apical base region of the heart.
22. The method ofclaim 18 , wherein the target region comprises a wall of the left ventricle.
23. The method ofclaim 18 , wherein: the identified target region comprises at least one of normal tissue, infarcted tissue, peri-infarcted tissue and ischemic tissue.
24. The method ofclaim 23 , wherein the self-anchoring mechanical device restricts or limits motion in the identified target region.
25. The method ofclaim 18 , wherein the mechanical device comprises a flexible member.
26. The method ofclaim 25 , wherein the mechanical device is placed in one of: a relaxed condition; and a pre-stretched condition.
27. A method of treating mitral valvular regurgitation, the method comprising:
providing a restraining device having a distal anchor and a proximal anchor;
embedding the distal anchor of the device in heart tissue; and
embedding the proximal anchor in the heart tissue, wherein the restraining device is substantially positioned in a mid-wall of the heart and oriented approximately parallel to an endocardial surface in an apex-to-base direction to adjust a position of a base of at least one papillary muscle coupled to a mitral valve.
28. The method as recited inclaim 27 , further comprising: adjusting an amount of tension between the distal anchor and the proximal anchor on the restraining device, the tension urging the anchors toward one another.
29. The method as recited inclaim 28 , further comprising: embedding the proximal anchor in the heart tissue while the device is under tension.
30. The method as recited inclaim 27 , wherein: tension of the restraining device causes a decrease in a distance from a base of the papillary muscle to the mitral valve plane.
31. The method as recited inclaim 27 , wherein the heart tissue in which the restraining device is positioned comprises at least one of: peri-infarcted heart tissue; infarcted heart tissue; ischemic heart tissue; and non-ischemic heart tissue.
32. The method ofclaim 28 , wherein the restraining device comprises a flexible member and adjusting the amount of tension of the restraining device comprises at least one of: placing the restraining member in a relaxed condition; and placing the restraining member in a pre-stretched condition.
33. A method of treating a heart, the method comprising:
providing a restraining device having a distal anchor and a proximal anchor;
embedding the distal anchor of the device in heart tissue; and
embedding the proximal anchor in the heart tissue, wherein the restraining device is substantially positioned in a mid-wall of the heart.
34. The method as recited inclaim 33 , further comprising: orienting the restraining device to adjust a position of a base of at least one papillary muscle coupled to a mitral valve.
35. The method as recited inclaim 33 , further comprising: orienting the restraining device approximately parallel to an endocardial surface in an apex-to-base direction.
36. The method as recited inclaim 35 , further comprising: adjusting a tension of the restraining device to decrease a distance from a base of a papillary muscle to a mitral valve plane.
37. The method as recited inclaim 33 , further comprising: orienting the restraining device approximately parallel to a circumferential plane of the heart.
38. A method of treating a heart with mitral valvular regurgitation as recited inclaim 33 .
39. A method of treating a heart in which a myocardial infarction has occurred as recited inclaim 33.
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| US11/403,859US20060195012A1 (en) | 1997-12-17 | 2006-04-14 | Valve to myocardium tension members device and method |
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| US08/992,316US6332893B1 (en) | 1997-12-17 | 1997-12-17 | Valve to myocardium tension members device and method |
| US09/981,790US8187323B2 (en) | 1997-12-17 | 2001-10-19 | Valve to myocardium tension members device and method |
| US11/172,437US8226711B2 (en) | 1997-12-17 | 2005-07-01 | Valve to myocardium tension members device and method |
| US11/403,859US20060195012A1 (en) | 1997-12-17 | 2006-04-14 | Valve to myocardium tension members device and method |
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| US11/172,437ContinuationUS8226711B2 (en) | 1997-12-17 | 2005-07-01 | Valve to myocardium tension members device and method |
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| US08/992,316Expired - LifetimeUS6332893B1 (en) | 1997-12-17 | 1997-12-17 | Valve to myocardium tension members device and method |
| US09/981,790Expired - Fee RelatedUS8187323B2 (en) | 1997-12-17 | 2001-10-19 | Valve to myocardium tension members device and method |
| US10/679,691AbandonedUS20040127983A1 (en) | 1997-12-17 | 2003-10-07 | Valve to myocardium tension members device and method |
| US11/172,437Expired - Fee RelatedUS8226711B2 (en) | 1997-12-17 | 2005-07-01 | Valve to myocardium tension members device and method |
| US11/403,859AbandonedUS20060195012A1 (en) | 1997-12-17 | 2006-04-14 | Valve to myocardium tension members device and method |
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| US09/981,790Expired - Fee RelatedUS8187323B2 (en) | 1997-12-17 | 2001-10-19 | Valve to myocardium tension members device and method |
| US10/679,691AbandonedUS20040127983A1 (en) | 1997-12-17 | 2003-10-07 | Valve to myocardium tension members device and method |
| US11/172,437Expired - Fee RelatedUS8226711B2 (en) | 1997-12-17 | 2005-07-01 | Valve to myocardium tension members device and method |
Country Status (6)
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| US (5) | US6332893B1 (en) |
| EP (2) | EP1039851B1 (en) |
| AT (1) | ATE299683T1 (en) |
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| WO (1) | WO1999030647A1 (en) |
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Also Published As
| Publication number | Publication date |
|---|---|
| US20040127983A1 (en) | 2004-07-01 |
| WO1999030647A1 (en) | 1999-06-24 |
| DE69830928T2 (en) | 2006-04-20 |
| US20020029080A1 (en) | 2002-03-07 |
| US6332893B1 (en) | 2001-12-25 |
| US8187323B2 (en) | 2012-05-29 |
| EP1039851B1 (en) | 2005-07-20 |
| EP1637091A2 (en) | 2006-03-22 |
| US20060052868A1 (en) | 2006-03-09 |
| EP1637091A3 (en) | 2010-09-22 |
| ATE299683T1 (en) | 2005-08-15 |
| US8226711B2 (en) | 2012-07-24 |
| AU2199899A (en) | 1999-07-05 |
| EP1637091B1 (en) | 2016-10-26 |
| DE69830928D1 (en) | 2005-08-25 |
| EP1039851A1 (en) | 2000-10-04 |
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