US20040102840A1 - Method and device for treatment of mitral insufficiency - Google Patents
Method and device for treatment of mitral insufficiency Download PDFInfo
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- US20040102840A1 US20040102840A1 US10/714,462 US71446203A US2004102840A1 US 20040102840 A1 US20040102840 A1 US 20040102840A1 US 71446203 A US71446203 A US 71446203A US 2004102840 A1 US2004102840 A1 US 2004102840A1
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- guide wire
- introducer
- coronary sinus
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- heart
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- 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
- A61F2/2451—Inserts in the coronary sinus for correcting the valve shape
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/88—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure the wire-like elements formed as helical or spiral coils
-
- 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
- A61F2/82—Devices providing patency to, or preventing collapsing of, tubular structures of the body, e.g. stents
- A61F2/86—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure
- A61F2/90—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure
- A61F2/91—Stents in a form characterised by the wire-like elements; Stents in the form characterised by a net-like or mesh-like structure characterised by a net-like or mesh-like structure made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
-
- 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
- A61F2/04—Hollow or tubular parts of organs, e.g. bladders, tracheae, bronchi or bile ducts
- A61F2/06—Blood vessels
- A61F2/07—Stent-grafts
- A61F2002/075—Stent-grafts the stent being loosely attached to the graft material, e.g. by stitching
-
- 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
- A61F2220/00—Fixations or connections for prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2220/0008—Fixation appliances for connecting prostheses to the body
-
- 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
- A61F2230/00—Geometry of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
- A61F2230/0063—Three-dimensional shapes
- A61F2230/0073—Quadric-shaped
- A61F2230/0078—Quadric-shaped hyperboloidal
Abstract
A device for treatment of mitral annulus dilatation comprises an elongate body having two states. IN a first of these states the elongate body is insertable into the coronary sinus and has a shape adapting to the shape of the coronary sinus. When positioned in the coronary sinus, the elongate body is transferable to the second state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus and the radius of curvature as well as the circumference of the mitral annulus is reduced.
Description
- This application is a continuation-in-part of U.S. patent application Ser. No. 09/345,475 that was filed on Jun. 30, 1999.
- 1. Technical Field of the Invention
- The present invention generally relates to a device and a method for treatment of mitral insufficiency and, more specifically, for treatment of dilatation of the mitral annulus.
- 2. Description of the Prior Art
- Mitral insufficiency can result from several causes, such as ischemic disease, degenerative disease of the mitral apparatus, rheumatic fever, endocarditis, congenital heart disease and cardiomyopathy. The four major structural components of the mitral valve are the annulus, the two leaflets, the chordae and the papillary muscles. Any one or all of these in different combinations may be injured and create insufficiency. Annular dilatation is a major component in the pathology of mitral insufficiency regardless of cause. Moreover, many patients have a mitral insufficiency primarily or only due to posterior annular dilatation, since the annulus of the anterior leaflet does not dilatate because it is anchored to the fibrous skeleton of the base of the heart.
- Studies of the natural history of mitral insufficiency have found that totally asymptomatic patients with severe mitral insufficiency usually progress to severe disability within five years. At present the treatment consists of either mitral valve replacements or repair, both methods requiring open heart surgery. Replacement can be performed with either mechanical or biological valves.
- The mechanical valve carries the risk of thromboembolism and requires anticoagulation, with all its potential hazards, whereas biological prostheses suffer from limited durability. Another hazard with replacement is the risk of endocarditis. These risks and other valve related complications are greatly diminished with valve repair.
- Mitral valve repair is theoretically possible if an essentially normal anterior leaflet is present. The basic four techniques of repair include the use of an annuloplasty ring, quadrangular segmental resection of diseased posterior leaflet, shortening of elongated chordae, and transposition of posterior leaflet chordae to the anterior leaflet.
- Annuloplasty rings are needed to achieve a durable reduction of the annular dilatation. All the common rings are sutured along the posterior mitral leaflet adjacent to the mitral annulus in the left atrium. The Duran ring encircles the valve completely, whereas the others are open towards the anterior leaflet. The ring can either be rigid, like the original Carpentier ring, or flexible but non-elastic, like the Duran ring or the Cosgrove-Edwards ring.
- Effective treatment of mitral insufficiency currently requires open-heart surgery, by the use of total cardiopulmonary by-pass, aortic cross-clamping and cardioplegic cardiac arrest.
- To certain groups of patient, this is particular hazardous. Elderly patients, patients with a poor left ventricular function, renal disease, severe calcification of the aorta, previous cardiac surgery or other concomitant diseases, would in particular most likely benefit from a less invasive approach, even if repair is not complete. The current trend towards less invasive coronary artery surgery, without cardiopulmonary by-pass, as well as PTCA will also call for a development of a less invasive method for repair of the often concomitant mitral insufficiency.
- Therefore, a first object of the present invention is to provide a device and a method for treatment of mitral insufficiency without the need for cardiopulmonary by-pass and without opening of the chest and heart.
- A second object of the invention is to provide reduction of the mitral annulus using only catheter based technology.
- According to the present invention, a device for treatment of mitralis insufficiency comprises an elongate body having such dimensions as to be insertable into the coronary sinus and having two states, in a first state of which the elongate body has a shape that is adaptable to the shape of the coronary sinus, and to the second state of which the elongate body is transferable from the said first state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus is reduced as well as the circumference of the mitral valve annulus, when the elongate body is positioned in the coronary sinus. More precisely, the elongate body comprises a distal stent section, a proximal stent section and control wires for reducing the distance between the distal and proximal stent sections.
- Thus, means are provided for the transfer of the elongate body to the second stat by shortening it from a larger radius of curvature to a smaller radius of curvature.
- The control wires may comprise a first wire and means for guiding said first wire in a course extending two times between the distal and proximal stent sections, when the distance therebetween is at a maximum, and extending at least three times between the distal and proximal stent sections, when the distance therebetween is at a minimum.
- To accomplish changes in the course, the guiding means preferably comprises a first eyelet fixed to one of the distal and proximal stent sections, a second eyelet fixed to the other of the distal and proximal stent sections, and a third eyelet positioned between the distal and proximal stent sections, said first wire having a first end fixed to said one of the distal and proximal stent section and extending therefrom via the third eyelet, the first eyelet and the second eyelet back to the third eylet where a second end of the first wire is fixed. By this structure the maximum distance between the two stent sections will be about 1.5 times the minimum distance between the two stent sections.
- A larger quotient may be obtained by extending the first wire from the first eyelet at least once more via the third eyelet and the first eyelet before finally extending the first wire via the second eyelet back to the third eylet where the second end of the first wire is fixed.
- In order to reduce the distance beteween the distal stent section and the proximal stent section, said first eyelet is preferably fixed to the distal stent section and said control wires comprise a second wire extending through the third eyelet and as a double wire proximally therefrom out of the coronary sinus and out of the human body. As an alternative to this second wire, a single wire may be used having an end releasably fixed to the third eyelet and extending as a single wire proximally therefrom out of the coronary sinus and out of the human body. However, to be able to also increase the distance between the distal stent section and the proximal stent section, said control wires may comprise a third wire extending through the third eyelet and as a double wire distally to and through the first eyelet and then as a double wire proximally therefrom out of the coronary sinus and out of the human body.
- Alternatively, the distance between the distal stent section and the proximal stent section may be reduced by fixing the first eyelet to the proximal stent section. Then, said control wires should comprise a second wire extending through the third eyelet and as a double wire distally to and through the first eyelet and then as a double wire proximally therefrom out of the coronary sinus and out of the human body. In order to be able to increase the distance between the distal stent section and the proximal stent section in this case, the control wires should comprise a third wire extending through the third eyelet and as a double wire proximally therefrom out of the coronary sinus and out of the human body.
- It should be noted that when the proximal and distal stent sections have been fixed relative to the coronary sinus and the distance between them thererafter has been finaly adjusted to a desired value, the second and the third wires may in both the described alternatives be withdrawn from the coronary sinus by pulling one of their ends positioned outside of the coronary sinus and outside of the human body.
- In preferred embodiments of the device, a cover encloses the wires in their courses between the distal and proximal stent sections so as to eliminate the risk that the wires will injure the coronary sinus by cutting into its internal surfaces.
- The cover may comprise one or more plastic sheaths and may also comprise one or more helical wires.
- In an alternative embodiment, the device for treatment of mitral annulus dilatation comprises an elongate body having such dimensions as to be insertable into the coronary sinus and having two states, in a first of which the elongate body has a shape that is adaptable to the shape of the coronary sinus, and to the second of which the elongate body is transferable from said first state assuming a reduced radius of curvature, whereby the radius of curvature of the coronary sinus is reduced as well as the circumference of the mitral valve annulus, when the elongate body is positioned in the coronary sinus, said elongate body comprising at least one stent section at a distance from each end of the elongate body, said stent section providing a reduction of its length when expanded in situ in the coronary sinus, whereby the elongate body is shortened and bent to a smaller radius of curvature.
- Preferably, the elongate body of this embodiment comprises a proximal stent section, a distal stent section and a central stent section, the distal and proximal stent sections being expandable prior to the central stent section. Obviosly, this will result in a reduction of the distance between the proximal and distal stent sections. Further, the proximal and distal stent sections should be expandable without substantial length reduction.
- Thus, the present invention takes advantage of the position of the coronary sinus being close to the mitral annulus. This makes repair possible by the use of current catheter-guided techniques.
- The coronary veins drain blood from the myocardium to the right atrium. The smaller veins drain blood directly into the atrial cavity, and the larger veins accompany the major arteries and run into the coronary sinus which substantially encircles the mitral orifice and annulus. It runs in the posterior atrioventricular groove, lying in the fatty tissue between the left atrial wall and the ventricular myocardium, before draining into the right atrium between the atrial septum and the post-Eustachian sinus.
- In an adult, the course of the coronary sinus may approach within 5-15 mm of the medial attachment of the posterior leaflet of the mitral valve. Preliminary measurements performed at autopsies of adults of normal weight show similar results, with a distance of 5.3±0.6 mm at the medial attachment and about 10 mm at the lateral aspect of the posterior leaflet. The circumference of the coronary sinus was 18.3±2.9 mm at its ostium (giving a sinus diameter of the septal aspect or the posterior leaflet of 5.8±0.9 mm) and 9.7±0.6 mm along the lateral aspect of the posterior leaflet (corresponding to a sinus diameter of 3.1±0.2 mm).
- The invention will be better understood by the following description of preferred embodiments referring to the appended drawings, in which
- FIG. 1 is a cross-sectional view of a part of a heart,
- FIGS. 2 and 3 are schematic views of a first embodiment of a device according to the present invention,
- FIGS.4-6 are schematic views illustrating an instrument, which may be used when positioning the device shown in FIGS. 2 and 3 in the coronary sinus,
- FIG. 7 is a partial, enlarged view of the first embodiment shown in FIG. 2.
- FIGS. 8 and 9 are schematic views illustrating the positioning of the device of FIGS. 2 and 3 in the coronary sinus,
- FIGS. 10 and 11 are schematic views illustrating the positioning of a second embodiment of the device according to the present invention in the coronary sinus,
- FIGS. 12 and 13 are schematic views illustrating the positioning of a third embodiment of the device according to the present invention in the coronary sinus.
- FIG. 14 illustrates a fourth embodiment of the device according to the present invention.
- FIG. 15 is a schematic view illustrating a preferred operation of the fourth embodiment.
- FIG. 16 is a schematic view illustrating the operation of a fifth embodiment of the device according to the present invention.
- FIG. 17 illustrates a sixth embodiment of the device according to the present invention.
- FIG. 18 illustrates a further modification of the embodiments of FIGS.14-17.
- FIGS. 19 and 20 illustrate a seventh embodiment of the device according to the present invention.
- FIG. 1 is a cross-sectional view through the heart area of the posterior atrioventricular groove1, which is filled with fatty tissue. It shows the posterior leaflet of the mitral valve and the adjoining
parts coronary sinus 5 is shown close to themitral annulus 6 and behind theattachment 7 of theposterior leaflet 2. Since thecoronary sinus 5 substantially encircles themitral annulus 6, a reduction of the radius of curvature of the bentcoronary sinus 5 also will result in a diameter and circumference reduction of the mitral 5annulus 6. - The device of FIG. 2 comprises an
elongate body 8 made of memory metal, e.g. Nitinol, or other similar material which has a memory of an original shape, illustrated in FIG. 3, and can be temporary forced into another shape, illustrated in FIG. 2. Thiselongate body 8 comprises one, two or morememory metal strings 9 of helical or other shape so as to fit together and be able of permitting the movements described below. Along theelongate body 8several hooks 10 are fastened so as to extend radially out therefrom. These hooks 10 are covered by acover sheath 11 in FIG. 2. - The
elongate body 8 is forced into a stretched or extended state by means of a stabilizinginstrument 12 shown in FIG. 4. Thisinstrument 12 has twoarms 13 at adistal end 14 of arod 15 and a locking means 16 at a proximal end of therod 15. The distance between the ends of therod 15 corresponds to the desired length of theelongate body 8 when being insert d into thecoronary sinus 5. - The
arms 13 are free to move between the position shown in FIG. 4 and a position in alignment with therod 15, as shown in FIG. 6. The locking means 16 has two lockingknobs 17, which are pressed radially outwards from therod 15 by twospring blades 18. Thus, theelongated body 8 can be pushed over therod 15 of the stabilizinginstrument 12, then stretched between thearms 13 and theknobs 17, and finally locked in its stretched state on the stabilizinginstrument 12 between thearms 13 and theknobs 17, as illustrated in FIG. 5. - The
rod 15 may be a metal wire which is relatively stiff between thedistal end 14 and the locking means 16 but still so bendable that it will follow the shape of thecoronary sinus 5. Proximally of the locking means 16 the metal wire of the stabilizinginstrument 11 is more pliable to be able to easily follow the bends of the veins. - The above-described
elongate body 8 is positioned in thecoronary sinus 5 in the following way: - An introduction sheath (not shown) of synthetic material may be used to get access to the venous system. Having reached access to the venous system, a long guiding wire (not shown) of metal is advanced through the introduction sheath and via the venous system to the
coronary sinus 5. This guiding wire is provided with X-ray distance markers so that the position of the guiding wire in thecoronary sinus 5 may be monitored. - The
elongate body 8 is locked onto the stabilizinginstrument 12, as shown in FIG. 5, and introduced into thelong cover sheath 11 of synthetic material. This aggregate is then pushed through the introduction sheath and the venous system to thecoronary sinus 5 riding on the guiding wire. After exact positioning of the elongate body B in thecoronary sinus 5, as illustrated in FIG. 8 where themitral valve 19 is shown having acentral gap 20, thecover sheath 11 is retracted exposing theelongate body 8 within thecoronary sinus 5. This maneuver allows thehooks 10 on theelongate body 8 to dig into the walls of thecoronary sinus 5 and into the heart. Theelongate body 8 is still locked on to the stabilizinginstrument 12 such that thehooks 10 engage the walls of thecoronary sinus 5 in the stretched or extended state of theelongate body 8. - A
catheter 21, shown in FIG. 6, is pushed forward on the guiding wire and therod 15 for releasing theelongate body 8 from the locking means 16 by pressing thespring blades 18 towards therod 15. This movement releases theknobs 17 as well as thearms 13 from engagement with theelongate body 8 which contracts as illustrated in FIG. 9, thereby shortening the radius of curvature of the coronary sinus. As a result, themitral valve annulus 6 shrinks moving the posterior part thereof forward (shown by arrows in FIG. 9). This movement reduces the circumference of themitral valve annulus 6 and thereby closes thecentral gap 20. - FIG. 7 illustrates a part of an arrangement of the
wires 9 and thehooks 10 along a peripheral part of theelongate body 8, whereby theelongate body 8 will be asymmetrically contracted resulting in a bending thereof when interconnectingparts 22 of at least some of thehooks 10 are shortened to an original shape. - FIGS. 10 and 11 illustrate an alternative embodiment of an
elongate body 8′, which is a solid wire in the shape of an open U-shaped ring that will engage the wall of thecoronary sinus 5 most adjacent to themitral valve annulus 6 when inserted into thecoronary sinus 5. Theelongate body 8′ consists of a memory metal material which when reverting to its original shape will bend as illustrated in FIG. 11. The return of theopen ring 8′ to its original shape may be initiated in several ways, as is obvious to the man skilled in the art. - The third embodiment of the
elongate body 8″, illustrated in FIGS. 12 and 13, comprises three stent sections 23-25 positioned at one end of theelongate body 8″, at the middle thereof and at the other end of theelongate body 8″, respectively. These stent sections 23-25 may be positioned in thecoronary sinus 5 as illustrated by conventional means, such that their positions are fixed. They are connected bywires adjacent stent sections coronary sinus 5 most adjacent to the posterior part of themitral valve annulus 6. Thereby, theelongate body 8″ is bent, as illustrated in FIG. 13, and presses thecoronary sinus 5 against themitral valve annulus 6 closing thegap 20. - A fourth embodiment of the device is shown in FIG. 14 as comprising two stent sections, more precisely a
proximal stent section 30 and adistal stent section 31. The fourth embodiment further comprises afirst eyelet 32, which is fixed to a preferably proximal part of the thedistal stent section 31, asecond eyelet 33, which is fixed to a preferably distal part of theproximal stent section 30, and athird eyelet 34, which is positioned between the proximal anddistal stent sections sections wire 35, one end of which is fixed to the thedistal stent section 31. Thewire 35 may be fixed to thdistal stent section 31 at a proximal point, as shown in FIG. 14, or at a more distal point up to the distal end of thedistal stent section 31. - From the
distal stent section 31 thewire 35 extends to and through thethird eyelet 34 and then back towards thedistal stent section 31 to and through thefirst eyelet 32. From thefirst eyelet 32 thewire 35 then extends to and through thesecond eyelet 33 and then finally to thethird eyelet 34, the other end of thewire 35 being fixed to thisthird eyelet 34. - By moving the
third eyelet 34 towards theproximal stent section 30, the distance between the proximal anddistal stent sections third eyelet 34 towards thedistal stent section 31, the distance between the proximal and distal stent sections may be increased. However, such increase will require some means pushing thedistal stent section 31 in a distal direction away from theproximal stent section 30 or pulling the proximal stent section in a proximal direction away from thedistal stent section 31. - The distance between the proximal and
distal stent sections third eyelet 34 is positioned close to thedistal stent section 31 and will reach a minimum when thethird eyelet 34 is positioned close to theproximal stent section 30. - The
third eyelet 34 may be moved towards theproximal stent section 30 by means of asingle wire 36, which has an end releasably fixed to thethird eyelet 34 and extends proximally therefrom through theproximal stent section 30 and furter proximally out of thecoronary sinus 5, through the vein system and out of the human body. - In a preferred embodiment schematically illustrated in FIG. 15, a
second wire 37 extends through thethird eyelet 34 and further extends as a double wire proximally from thethird eyelet 34, through theproximal stent section 30 and thecoronary sinus 5 and then out of the body. Thethird eyelet 34 will be moved proximally by simultaneous pulling both ends of thesecond wire 37 outside of the body. When the desired position of thethird eyelet 34 is reached, thesecond wire 37 may easily be removed through the vein system by pulling only one of its ends outside the body. - As illustrated in FIG. 15, a
third wire 38 may be extended through thethird eyelet 34. Therefrom it extends as a double wire distally to and through thefirst eyelet 32 and then this double wire extends proximally from the first eyelet 32 (or a further eyelet fixed to the proximal end of the distal stent) through theproximal stent section 30 and finally thedouble wire 38 extends proximally through thecoronary sinus 5 and out of the human body. By pulling both ends of thisthird wire 38 outside of the body, thethird eyelet 34 will allow a movement of the proximal anddistal stent sections second wire 37 and thethird wire 38 the position of thethird eyelet 34 may be adjusted repeatedly until a desired position is attained. Thethird wire 38 may be removed in the same manner as thesecond wire 37. - Obviously, the position of the
third eyelet 34 may be used to control the distance between the proximal anddistal Stent sections coronary sinus 5. - The furter embodiment of the device illustrated in FIG. 16 corresponds to the embodiment illustrated in FIG. 15 except that the
first eyelet 32 is fixed to theproximal stent section 30 and thesecond eyelet 33 is fixed to thedistal stent section 31. Therefore, afourth wire 39 has the same extension as thethird wire 38 in FIG. 15 but has the function of thesecond wire 37 in FIG. 15. Afifth wire 40 has the same extension as thesecond wire 37 in FIG. 15 but has the function of thethird wire 38 of FIG. 15. - The quotient between the maximum distance and the minimum distance between the
proximal stent section 30 and thedistal stent section 31 in FIGS. 15 and 16 is about 1.5. A quotient of about 2.5 would be possible by letting thewire 35 extend once more via thethird eyelet 34 and the first eyelet 32 (or another eyelet fixed at substantially the same position as the first eyelet) before finally extending via thesecond eyelet 33 back to thethird eyelet 34 where the second end of thewire 35 is fixed, as shown in FIG. 17. - According to FIG. 18, the wires35-40 extending between the
proximal stent section 30 and thedistal stent section 31 are confined in a plastic sheath or aplastic wire spiral 41 which will cover and protect the wires 35-40. By enclosing the wires 35-40, the sheath or spiral 41 will also prohibit them from cutting through the wall of thecoronary sinus 5. Alternatively, more than one sheath or spiral 41 may be used, all of which should be compressible lengthwise so as to allow the reduction of the distance between the proximal anddistal stent sections - The embodiments illustrated in FIGS.15-18 may be introduced by conventional means into the
coronary sinus 5 via the vein system. Preferably, thedistal stent section 31 first is adjusted to a desired position, whereupon it is expanded so as to engage the walls of thecoronary sinus 5. Thereby, the position of thedistal stent section 31 is fixed in thecoronary sinus 5. Then the position of theproximal stent section 30 is adjusted considering the required reduction of the distance between the the proximal anddistal stent sections proximal stent section 30 is expanded such that it is fixed relative thecoronary sinus 5. Finally, the distance between the proximal anddistal stent sections wires stent sections wires - It should be noted that instead of eyelets having a single opening, eyelets having multiple openings could be used such that each one of the wires extends through an opening of its own.
- Still one further embodiment of the device according to the present invention is illustrated in FIGS. 19 and 20. Here, the device comprises an elongate body having three stent sections, the
proximal stent section 30 and thedistal stent section 31 being of the same type as described above. Acentral stent section 42 is such as to reduce its length when expanded radially. - When this device is positioned in the
coronary sinus 5, the proximal anddistal sections central stent section 42 is expanded. As a consequence of its length reduction when expanded, thecentral stent section 42 will reduce the distance between the proximal anddistal stent sections coronary sinus 5 as illustrated in FIG. 20. - Concludingly, the present invention provides a device placed in the
coronary sinus 5 and designed to reduce the dilatation of the mitral annulus. This device is at a distance from the attachment of the posterior leaflet that does not much exceed the distance at which present annuloplasty rings are placed by open surgery techniques, and the coronary sinus is along its entire course large enough to hold such a device. The device could be positioned by catheter technique or any other adequate technique and offers a safer alternative to the current open surgery methods. The device could be designed or heparincoated so as to avoid thrombosis in the coronary sinus, thus reducing the need for aspirin, ticlopedine or anticoagulant therapy. - It is to be understood that modifications of the above-described device and method can be made by people skilled in the art without departing from the spirit and scope of the invention.
Claims (25)
1. An assembly for effecting the condition of a mitral valve annulus of a heart comprising:
a guide wire configured to be advanced to the coronary sinus of the heart; and
a mitral valve annulus device configured to be received on the guide wire and advanced into the coronary sinus of the heart on the guide wire and that reshapes the mitral valve annulus when in the coronary sinus of the heart.
2. The assembly of claim 1 wherein the device is configured to be slidingly received on the guide wire.
3. The assembly of claim 1 wherein the mitral valve annulus device has opposed ends and includes a guide wire engaging structure at at least one of the opposed ends.
4. The assembly of claim 3 wherein the guide wire engaging structure includes a bore dimensioned to permit the guide wire to pass therethrough.
5. The assembly of claim 4 wherein the device further includes a guide wire confining channel extending between the opposed ends.
6. The assembly of claim 4 wherein the bore of the guide wire engaging structure is cylindrical in configuration.
7. The assembly of claim 6 wherein the device further includes a guide wire confining channel extending between the opposed ends and aligned with the bore.
8. The assembly of claim 1 wherein the guide wire is formed of a material visible under X ray.
9. The assembly of claim 1 wherein at least a portion of the device is visible under X ray.
10. The assembly of claim 1 wherein the device is visible under X ray.
11. The assembly of claim 1 further including an elongated introducer configured to be received on the guide wire proximal to the device.
12. The assembly of claim 11 wherein the introducer is configured to be slidingly received on the guide wire.
13. The assembly of claim 11 wherein the assembly further includes a releasable locking mechanism configured to releasably lock the device to the introducer.
14. The assembly of claim 11 further including a guide tube having an inner lumen dimensioned for receiving the guide wire and the device and introducer when the device and introducer are received on the guide wire.
15. A method of deploying a mitral valve annulus constricting device within the coronary sinus of a heart, the method including the steps of:
A. providing an elongated guide wire having a cross sectional dimension;
B. advancing the guide wire to the coronary sinus of the heart;
C. providing a guide tube having an inner lumen, the inner lumen having a cross sectional dimension greater than the cross sectional dimension of the guide wire;
D. advancing the guide tube to the coronary sinus of the heart on the guide wire with the guide wire within the inner lumen of the guide tube;
E. providing a mitral valve annulus device configured to be received on the guide wire and within the inner lumen of the guide tube, the device including a proximal end;
F. providing a flexible elongated introducer configured to be received on the guide wire and within the inner lumen of the guide tube, the introducer having a distal end;
G. placing the device onto the guide wire;
H. placing the introducer onto the guide wire;
I. engaging the introducer with the device;
J. pushing the device with the introducer in a distal direction along the guide wire and within the guide tube until the device is at least partially encircling the mitral valve within the coronary sinus of the heart; and
K. withdrawing the introducer and the guide tube from the heart.
16. The method of claim 15 wherein the engaging step includes the step I(1) of releasably locking the device to the introducer.
17. The method of claim 16 including the further step J(1) of releasing the device from the introducer prior to withdrawing the introducer.
18. A method of deploying a mitral valve annulus reshaping device within the coronary sinus of a heart, the method including the steps of:
advancing a guide wire to the coronary sinus of the heart;
advancing the elongated mitral valve annulus reshaping device on the guide wire and into the coronary sinus into a position such that the device at least partially encircles the mitral valve of the heart.
19. The method of claim 18 wherein the advancing step further includes the steps of mounting an elongated flexible introducer onto the guide wire, engaging the introducer with the device, and pushing the device distally into the coronary sinus with the introducer.
20. The method of claim 19 including the further step of withdrawing the introducer after deploying the device.
21. The method of claim 20 wherein the engaging step includes releasably locking the device to the introducer.
22. The method of claim 21 including the further step of releasing the device from the introducer prior to withdrawing the introducer.
23. The method of claim 19 including the further steps of:
providing an elongated flexible guide tube having an inner lumen, the inner lumen having a cross sectional dimension greater than the cross sectional dimension of the guide wire;
advancing the guide tube to the coronary sinus of the heart over the guide wire with the guide wire within the inner lumen of the guide tube; and
wherein the pushing step includes pushing the device along the guide wire and within the guide tube.
24. The method of claim 23 wherein the engaging step includes releasably locking the device to the introducer.
25. The method of claim 24 including the further steps of releasing the device from the introducer and withdrawing the introducer and the guide tube after deploying the device.
Priority Applications (1)
Application Number | Priority Date | Filing Date | Title |
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US10/714,462 US20040102840A1 (en) | 1999-06-30 | 2003-11-13 | Method and device for treatment of mitral insufficiency |
Applications Claiming Priority (3)
Application Number | Priority Date | Filing Date | Title |
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US09/345,475 US6210432B1 (en) | 1999-06-29 | 1999-06-30 | Device and method for treatment of mitral insufficiency |
US09/775,677 US7192442B2 (en) | 1999-06-30 | 2001-02-05 | Method and device for treatment of mitral insufficiency |
US10/714,462 US20040102840A1 (en) | 1999-06-30 | 2003-11-13 | Method and device for treatment of mitral insufficiency |
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US09/775,677 Continuation US7192442B2 (en) | 1999-06-30 | 2001-02-05 | Method and device for treatment of mitral insufficiency |
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US20040102840A1 true US20040102840A1 (en) | 2004-05-27 |
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US10/303,765 Expired - Lifetime US7090695B2 (en) | 1999-06-30 | 2002-11-26 | Method for treatment of mitral insufficiency |
US10/714,462 Abandoned US20040102840A1 (en) | 1999-06-30 | 2003-11-13 | Method and device for treatment of mitral insufficiency |
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US10/303,765 Expired - Lifetime US7090695B2 (en) | 1999-06-30 | 2002-11-26 | Method for treatment of mitral insufficiency |
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BR0116872A (en) | 2004-02-10 |
CA2434412A1 (en) | 2002-08-15 |
AU2002212216B2 (en) | 2006-11-30 |
EP1370200B1 (en) | 2007-05-23 |
EP1370200A1 (en) | 2003-12-17 |
WO2002062270A1 (en) | 2002-08-15 |
DE60128591D1 (en) | 2007-07-05 |
US20010018611A1 (en) | 2001-08-30 |
AU2006235972A1 (en) | 2006-11-30 |
US7192442B2 (en) | 2007-03-20 |
DE60128591T2 (en) | 2008-01-31 |
EP1806111A2 (en) | 2007-07-11 |
CA2434412C (en) | 2009-01-27 |
US7090695B2 (en) | 2006-08-15 |
EP1806111A3 (en) | 2007-07-18 |
US20030069636A1 (en) | 2003-04-10 |
ATE362737T1 (en) | 2007-06-15 |
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