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
  • A61F2/2442—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
  • A61F2/2451—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
  • A61F2/02—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
  • A61F2/2448—D-shaped rings
• • 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
  • A61F2/2466—Delivery devices therefor
• • 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
  • A61F2230/0091—Three-dimensional shapes helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• • 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
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0003—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof having an inflatable pocket filled with fluid, e.g. liquid or gas
• • 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
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0004—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable
  • A61F2250/001—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof adjustable for adjusting a diameter
• • 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
  • A61F2250/00—Special features of prostheses classified in groups A61F2/00 - A61F2/26 or A61F2/82 or A61F9/00 or A61F11/00 or subgroups thereof
  • A61F2250/0058—Additional features; Implant or prostheses properties not otherwise provided for
  • A61F2250/0096—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers
  • A61F2250/0098—Markers and sensors for detecting a position or changes of a position of an implant, e.g. RF sensors, ultrasound markers radio-opaque, e.g. radio-opaque markers

Definitions

• This invention pertains in general to the field of annuloplasty devices for treating a defective mitral valve. More particularly the invention relates to a medical system of devices for treating a defective mitral valve via coronary sinus and an annuloplasty implant for fixation of the annulus, and a method therefore.
• Mitral and tricuspid valve replacement and repair are frequently performed with aid of an annuloplasty ring, used to reduce the diameter of the annulus, or modify the geometry of the annulus in any other way, or aid as a generally supporting structure during the valve replacement or repair procedure.
• Implants have previously been introduced into the coronary sinus (CS) in order to affect the shape of the valve annulus and thereby the valve function.
• US 6,210,432 and WO02/062270 discloses such implant that is aimed to replace annuloplasty rings.
• Permanent implants have several disadvantageous effects, for example since they are implanted into the CS which is a source for later complications.
• a problem with the prior art implants in the CS is that such implants may be less effective in retaining the desired geometry of the annulus. It may be necessary for the implants to be positioned in the CS for a lengthy time in order to sustain the correct function of the valve. This pose significant requirements on the long-term function of the implant, that may not be as effective as annuloplasty rings to start with.
• a further problem with prior art is thus that complex and difficult-to-operate devices must be deployed in the CS, that may require frequent adjustment and repositioning to ensure the correct function over time.
• Another problem with prior art devices is the traumatic effects on the CS itself, due to fixation structures that must ensure the correct position of the device in the CS over time.
• Another problem is to ensure that a significant part of the annulus is reshaped while providing for atraumatic engagement with the anatomy. The above problems may have dire consequences for the patient and the health care system. Patient risk is increased.
• an improved annuloplasty device for performing downsizing and reshaping of the valve annulus would be advantageous and in particular allowing for ensuring long-term functioning, less complex procedure, and less traumatic effects on the anatomy and increased patient safety. Also, a method of downsizing and reshaping the mitral valve annulus with such medical annuloplasty device would be advantageous.
• examples of the present invention preferably seek to mitigate, alleviate or eliminate one or more deficiencies, disadvantages or issues in the art, such as the above-identified, singly or in any combination by providing a device according to the appended patent claims.
• displacement unit comprises a proximal reversibly expandable portion, a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape, wherein the proximal expandable portion is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS, and wherein the distal anchoring portion comprises an inflatable unit.
• the system comprises in
• an annuloplasty device for treating a defective mitral valve having an annulus comprising a removable and flexible elongate displacement unit for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit has a delivery state for delivery into the CS, and an activated state to which the displacement unit is temporarily and reversibly transferable from said delivery state, the displacement unit comprises a proximal reversibly expandable portion, a distal anchoring portion being movable in relation to the proximal expandable portion in a longitudinal direction of the displacement unit to said activated state in which the shape of the annulus is modified to a modified shape, wherein the proximal expandable portion is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS, and wherein the distal anchoring portion comprises an inflatable unit.
• CS coronary sinus
• the system comprises an annuloplasty device for permanent fixation at the mitral valve annulus by annuloplasty of the valve when said modified shape is obtained, wherein said annuloplasty device comprises a loop structure, such as a helix-shaped loop structure, configured to be positioned on either side of said valve to retain said modified shape of the annulus, wherein at least a portion of the loop structure conforms to a curvature of said annulus.
• said annuloplasty device comprises a loop structure, such as a helix-shaped loop structure, configured to be positioned on either side of said valve to retain said modified shape of the annulus, wherein at least a portion of the loop structure conforms to a curvature of said annulus.
• a method for treating a defective mitral valve having an annulus comprises inserting a flexible and removable elongate displacement unit in a delivery state into a coronary sinus (CS) adjacent said valve, positioning a proximal expandable portion against a tissue wall at the entrance of said CS, anchoring a distal anchoring portion comprising an inflatable unit inside the CS by expanding of the inflatable unit, activating the displacement unit in an activated state whereby the distal anchoring portion is moved in a longitudinal direction of the displacement unit to reduce a distance (L) between the distal anchoring portion and the proximal expandable portion such that the shape of the annulus is modified to a modified shape, fixating an annuloplasty device at the mitral valve annulus when said modified shape is obtained, whereby said annuloplasty device comprises a loop structure, such as a helix-shaped loop structure, positioned on either side of the valve to retain the modified shape of the annulus, wherein at least a portion of the loop structure is conformed to a
• Some examples of the disclosure provide for long-term functioning of the mitral valve.
• Some examples of the disclosure provide for less complex downsizing procedures of the mitral valve.
• Some examples of the disclosure provide for a reduced risk of damaging the anatomy such as the CS. Some examples of the disclosure provide for a secure downsizing while at the same time reducing the risk of damaging the anatomy such as the CS.
• Some examples of the disclosure provide for improved downsizing of the mitral valve annulus while ensuring an atraumatic procedure.
• Some examples of the disclosure provide for reduced risk of long-term negative effects of CS implants.
• Fig. 1 a is a schematic illustration of an annuloplasty device according to one example
• Fig. 1 b is a schematic illustration of an annuloplasty device, with an expanded proximal portion, according to one example
• Fig. 2a is a schematic illustration of an annuloplasty device, with an expanded proximal portion, according to one example
• Fig. 2b is a detailed view of the distal portion of the annuloplasty device in
• Figs. 3a-b are schematic illustrations of an annuloplasty device, with different lengths between proximal and distal portions, according to one example;
• Fig. 4 is a schematic illustration of an annuloplasty device according to one example
• Fig. 5 is a schematic illustration of a medical system for treating a defective mitral valve when placed in the heart, according to one example
• Fig. 6a is a flow chart of a method for treating a defective mitral valve according to one example.
• Fig. 6b is a flow chart of a method for treating a defective mitral valve according to one example.
• the invention is not limited to this application but may be applied to many other annuloplasty implants and cardiac valve implants including for example replacement valves, and other medical implantable devices.
• Fig. 1 schematically illustrates an annuloplasty device 100 for treating a defective mitral valve having an annulus.
• the annuloplasty device 100 comprises a removable and flexible elongate displacement unit 101 for temporary insertion into a coronary sinus (CS) adjacent the mitral valve.
• Fig. 5 is an illustration of the heart showing the CS in relation to the mitral valve (MV) in a top-down view.
• the CS lies adjacent the MV and follows a curvature around the annulus (A) of the MV.
• the displacement unit 101 has a delivery state for delivery into the CS, and an activated state to which the displacement unit 101 is temporarily and reversibly transferable from said delivery state.
• the displacement unit 101 comprises a proximal reversibly expandable portion 102, and a distal anchoring portion 103 being movable in relation to the proximal expandable portion in a longitudinal direction 104 of the displacement unit 101 to said activated state, so that a distance (L) between the proximal portion 102 and the distal anchoring portion 103 can be varied as seen in Figs. 3a-b.
• the annuloplasty device 100 when placed in the CS, modifies the annulus to a modified shape where the annulus is downsized and the leaflets may co-apt.
• the proximal expandable portion 102 is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS.
• the distal anchoring portion 103 comprises an inflatable unit, such as a balloon.
• This provides for efficient and non-traumatic fixation of the distal end of the displacement unit 101 , which in combination with the efficient anchoring against the wall of the CS by the proximal portion 102, allows for an efficient transfer of a contracting force of the proximal and distal portions 102, 103, towards each other.
• This allows for an effective modification of the radius of curvature of the CS to facilitate modifying the shape of the valve annulus.
• the modified shape of the annulus may then be fixed by attachment of an
• the proximal expandable portion 102 and the distal anchoring portion 103 may be connected to different sheaths or wires, that may be independently movable in the longitudinal direction 104 to provide for varying the distance (L) as illustrated in Figs. 3a-b.
• the proximal expandable portion 102 may comprise expandable bows 105 extending in the longitudinal direction 104, as schematically illustrated in e.g. Figs. 1 a-b. Having such expandable bows 105 provides for to further lessen the risk of damaging the tissue at the entrance of the CS, since a soft apposition against the tissue may be provided, in absence of sharp edges or kinks. Having the bows 105 extending in the longitudinal direction 104 also facilitates a symmetric engagement against the tissue wall, with an even transfer of force around the entrance to the CS, hence allowing for a robust anchoring.
• the longitudinal extension of the bows 105 also provides for facilitated expansion of the bows 105 by applying a force to the bows 105 in the longitudinal direction 104.
• the bows 105 may extend with a curvature forming an apex 1 16 at the middle portion of the bow 105, where the apex 1 16 is positioned at the maximum expanded diameter of the proximal expandable portion 102. Both portions of the bow 105 extending from the apex 1 16 may extend in the longitudinal direction 104.
• a plurality of bows 105, 105', may be arranged circumferentially so that a force may be applied symmetrically and evenly around the tissue wall.
• the expandable bows 105 may be connected to a sheath 106 and may be configured to be expanded in a radial direction 1 15, perpendicular to the longitudinal direction 104, by pushing a proximal portion 107 of the sheath 106 towards the distal anchoring portion 103, as indicated in Fig. 1 b (see arrow adjacent sheath 106). This provides for a facilitated deployment of the bows 105 to the expanded configuration.
• the sheath 1 16 may be pushed in relation to a distal portion 1 17 attached distally to the bows 105. The compressive force between the distal portion 1 17 and the proximal portion 107 may thus push the bows 105 radially outwards.
• the bows 105 may comprise a shape-memory material having a tendency to assume the expanded configuration in its relaxed state, and that the bows may be confined in an outer sheath (not shown) being pulled back so that the bows 105 spring into the expanded configuration.
• the bows 105 may comprise elongated ribs 108 formed in the sheath 106 by elongated cuts 108' in the sheath 106, extending in the longitudinal direction 104, as schematically illustrated in Fig. 1 a.
• This provides for a simple and robust construction from which the expandable bows 105 provided.
• the bows 105 may thus be formed from the same material as the sheath 106.
• the mentioned material may be a soft flexible material which is non-traumatic to tissue.
• the ribs 108 In the collapsed configuration seen in Fig. 1 a, the ribs 108, i.e. the soon to be expanded bows 105, extend in the longitudinal direction 104, and provides for a compact radial profile.
• the bows 105 may be placed equidistantly around a circumference of the sheath 106. As elucidated above, this may provide for an even distribution of the anchoring force.
• the expandable bows 105 may extend with a curvature forming an apex 1 16 positioned at a maximum expanded diameter (D) of the proximal expandable portion 102.
• Each of the bows 105 may extend with two expanded sections 1 18, 1 18', towards the apex 1 16, as illustrated in Fig. 4.
• the two expanded sections 1 18, 1 18' may comprise a proximal expanded section 1 18' and a distal expanded section 1 18.
• the distal expanded section 1 18 is configured to be arranged against the tissue wall at the entrance of the CS.
• At least a portion of the distal expanded section 1 18 may extend in a first direction 1 19 forming a first angle (vi ) with the radial direction 1 15, and at least a portion of the proximal expanded section 1 18' may extend in a second direction 1 19' forming a second angle (V2) with the radial direction 1 15.
• the first angle (vi ) may be less than the second angle (V2), as further shown in the example of Fig. 4. This provides for improving the support of the proximal expandable portion 102 against the tissue wall at the entrance of the CS. I.e.
• the distal expanded section 1 18 will be more parallel to the radial direction 1 15 than the proximal expanded section 1 18'. Since the tissue wall is typically also substantially parallel to the radial direction 1 15, the surface area of the distal expanded section 1 18 in contact with the tissue wall will increase. This provides for a more stable and robust anchoring point with less risk of movement of the in the proximal expandable portion 102 relative the tissue wall in the longitudinal direction 104.
• the first direction 1 19 may be substantially parallel with the radial direction 1 15, which provides for a stable positioning of the proximal expandable portion 102 relative the tissue wall at the entrance of the CS.
• the maximum expanded diameter (D) of the proximal expandable portion 102 may be at least three times the diameter of the CS. In some examples the ratio of the maximum expanded diameter (D) of the proximal expandable portion 102 to the diameter of the CS is in the range 3 - 5. In some examples the aforementioned ratio may be in the range 3.5 - 4.5, which provides for a particular advantageous anchoring of the proximal expandable portion 102, while maintaining a compact and easy to use device 100.
• the elongate displacement unit 101 may comprise a lumen 109 extending in the longitudinal direction 104.
• the lumen may have a distal opening 1 10 arranged distally of the inflatable unit 103, and at least one proximal opening 1 1 1 , 1 1 1 ', arranged between the inflatable unit 103 and the proximal
• expandable portion 102 as schematically illustrated in Figs. 2a-b. This provides for minimizing the risk of occlusion in the CS, since blood may flow between the distal opening 1 10 and the at least one proximal opening 1 1 1 , 1 1 1 '.
• the number of openings 1 1 1 , 1 1 1 ', may be varied to optimize the flow and minimize the risk of occlusion.
• the annuloplasty device 100 may comprise a guide wire 1 14 arranged to extend inside the lumen 109 and to exit the lumen 109 at the distal opening 1 10. This provides for facilitated positioning of the elongate displacement unit 101 .
• the lumen 109 may thus allow for both guiding of the guide wire 1 14 and for transport of blood between proximal openings 1 1 1 , 1 1 1 ', and the distal opening 1 10, which provides for a robust and compact annuloplasty device 100.
• the elongate displacement unit 101 may comprise at least one
• radiopaque marker 1 12, 1 12' arranged inside the inflatable unit 103, as schematically illustrated in Fig. 2b.
• the radiopaque marker 1 12, 1 12' is visible in medical imaging methods.
• the radiopaque marker 1 12, 1 12' may be arranged in the elongate displacement unit 101 and at a portion thereof extending through the inflatable unit 103. This provides for determining the position of the inflatable unit 103 while maintaining a robust and low-profile annuloplasty device 100.
• the annuloplasty device 100 may comprise an inflation lumen 1 13 connected to inflatable unit 103 and configured to deliver an inflation medium to the inflatable unit 103, as schematically illustrated in Fig. 2b.
• the distance (L) between the proximal expandable portion 102 and the distal anchoring portion 103 in the longitudinal direction 104 may be decreased to a reduced distance (U) when the displacement unit 101 is transferred from the delivery state to the activated state, as schematically illustrated in Figs. 3a-b.
• a medical system 200 is provided for treating a defective mitral valve having an annulus, as schematically illustrated in Fig. 5.
• the system 200 comprises in combination an annuloplasty device 100 as described above in relation to Figs. 1 - 4, and an annuloplasty implant 301 .
• the annuloplasty device 100 comprises a removable and flexible elongate displacement unit 101 for temporary insertion into a coronary sinus (CS) adjacent the valve, wherein the displacement unit 101 has a delivery state for delivery into the CS, and an activated state to which the displacement unit 101 is temporarily and reversibly transferable from said delivery state.
• CS coronary sinus
• the displacement unit 101 comprises a proximal reversibly expandable portion 102, a distal anchoring portion 103 being movable in relation to the proximal expandable portion 102 in a longitudinal direction 104 of the displacement unit 101 to said activated state in which the shape of the annulus is modified to a modified shape.
• the proximal expandable portion 102 is reversibly foldable to an expanded state for positioning against a tissue wall at the entrance of the CS, and the distal anchoring portion 103 comprises an inflatable unit.
• the annuloplasty implant 301 is configured for permanent fixation at the mitral valve annulus by annuloplasty of the valve when said modified shape is obtained.
• the annuloplasty device 301 comprises a loop structure 302, such as a helix- shaped loop structure, configured to be positioned on either side of said valve to retain said modified shape of the annulus, wherein at least a portion of the loop structure conforms to a curvature of said annulus.
• a loop structure 302 such as a helix- shaped loop structure, configured to be positioned on either side of said valve to retain said modified shape of the annulus, wherein at least a portion of the loop structure conforms to a curvature of said annulus.
• the annuloplasty device 100 may comprise a first support ring and a second support ring, being arranged in a coiled configuration around an axial direction.
• the first and second support rings may be adapted to be arranged on opposite sides of native heart valve leaflets to pinch said leaflets.
• annuloplasty implant 301 may have shape-memory properties, such that the first and second supports may assume an elongated configuration when delivered in a catheter, whereupon the first and second supports may assume the coiled configuration when ejected from the delivery catheter.
• annuloplasty implant 301 may also comprise closed single-loop rings, such as D-shaped rings, or open single-loop rings, such as C-shaped annuloplasty rings.
• Fig. 6a illustrates a method 400 for treating a defective mitral valve.
• the order in which the steps of the method 400 are illustrated should not be construed as limiting and it is conceivable that the order in which the steps of the method 400 is carried out may be varied.
• the method 400 comprises;
• the method 400 comprises fixating 405 an annuloplasty implant 301 at the mitral valve annulus when said modified shape is obtained, whereby the annuloplasty implant 301 comprises a loop structure 302, such as a helix-shaped loop structure, positioned on either side of the valve to retain the modified shape of the annulus. At least a portion of the loop structure is conformed to a curvature of the annulus.
• the method comprises removing 406 the elongate displacement unit 101 after temporary activation in the activated state.
• the method 400 thus provides for the advantageous benefits as described above in relation to the device 100 and system 200 and Figs. 1 - 5.
• Fig. 6b illustrates another flow chart of a method 400 for treating a defective mitral valve.
• Positioning of the proximal expandable portion 102 may comprise expanding 402' bows 105 extending in the longitudinal direction 104 for apposition against the tissue wall.
• the method 400 may further comprise exerting 404' of a force against the tissue wall in the longitudinal direction 104 towards the distal anchoring portion 103.
• Anchoring the distal anchoring portion 103 may comprise inflating 403' the inflatable unit 103 in the great cardiac vein and/or, in the anterior interventricular branch or vein, and/or in the posterior vein and/or in the posterior ventricular vein of the heart. This provides for improving the anchoring force of the distal anchoring portion 103.
• the method 400 may comprise guiding 401 ' the elongate displacement unit 101 along a guide wire 1 14 arranged to extend inside a lumen 109 of the elongate displacement unit 101 .
• the guide wire 1 14 may be arranged to exit the lumen at an opening 1 10 distally of the inflatable unit 103.
• the lumen 109 may have a proximal opening 1 1 1 arranged between the inflatable unit 103 and the proximal expandable portion 102.

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• Health & Medical Sciences (AREA)
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• Oral & Maxillofacial Surgery (AREA)
• Transplantation (AREA)
• Engineering & Computer Science (AREA)
• Biomedical Technology (AREA)
• Heart & Thoracic Surgery (AREA)
• Vascular Medicine (AREA)
• Life Sciences & Earth Sciences (AREA)
• Animal Behavior & Ethology (AREA)
• General Health & Medical Sciences (AREA)
• Public Health (AREA)
• Veterinary Medicine (AREA)
• Prostheses (AREA)

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• 2018
  • 2018-09-21 ES ES18782656T patent/ES2972801T3/es active Active
  • 2018-09-21 EP EP18782656.5A patent/EP3684295B1/en active Active
  • 2018-09-21 JP JP2020516520A patent/JP7326255B2/ja active Active
  • 2018-09-21 AU AU2018337712A patent/AU2018337712B2/en not_active Ceased
  • 2018-09-21 EP EP23208413.7A patent/EP4309626A3/en active Pending
  • 2018-09-21 CN CN202410240924.2A patent/CN118121367A/zh active Pending
  • 2018-09-21 WO PCT/EP2018/075713 patent/WO2019057947A1/en not_active Ceased
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• 2023
  • 2023-08-18 US US18/235,638 patent/US20240041604A1/en active Pending
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