ADJUSTABLE ANNULOPLASTY RING
20250090323 ยท 2025-03-20
Inventors
- John Richard Carpenter (Irvine, CA, US)
- Sai Prasad Uppalapati (Plano, TX, US)
- Luke Anthony Zanetti (Parkton, MD, US)
- Ashley Nicolette Hinga (Eldersburg, MD, US)
- Stephen Epstein (Millersville, MD, US)
- Jyoti B Rao (Brea, CA, US)
Cpc classification
A61F2230/0013
HUMAN NECESSITIES
A61F2210/0009
HUMAN NECESSITIES
International classification
Abstract
An annuloplasty ring for repair of mitral valves whose shape can be altered directly or remotely to perform post-implant size and/or shape adjustments. One version of the annuloplasty ring has a size-adjustable remodeling inner core within an outer suture-permeable interface for attaching the ring to an annulus. The inner core has a size-adjustable segment formed by short spaced-apart tubular sections that can move toward and way from one another such as on rails. Alternatively, short sections separated by compressible connectors may be used. One or more tethers may be attached to one side of the size-adjustable segment and pulled from the other side to constrict the segment. Multiple tethers may be connect at different locations around the ring to provide some control over where the ring constricts. An adjustment handle with a flexible shaft may be operated from outside the body to adjust the ring post-implant.
Claims
1. A mitral annuloplasty ring and shape adjustment system for implant at a mitral annulus surrounding an anterior leaflet and a posterior leaflet, the mitral annulus being D-shaped with a straighter anterior aspect bordering an anterior leaflet opposite a more rounded posterior aspect bordering a posterior leaflet, and the posterior leaflet defining P1, P2 and P3 regions in CCW sequence looking from the atrial side, comprising: an annuloplasty ring defining a peripheral shape around a central aperture, the peripheral shape being D-shaped with a straighter anterior side adapted to be implanted adjacent the anterior leaflet opposite a more rounded posterior side adapted to be implanted adjacent the posterior leaflet, the annuloplasty ring having an inner core and a suture-permeable interface surrounding the inner core and extending around the peripheral shape, the inner core having multiple arcuate segments on the posterior side that are linearly or circumferentially compressible to enable constriction of the ring while the anterior side is not size-adjustable, the system including a proximal control handle having a flexible shaft extending therefrom, a distal end of the shaft being adapted to engage an access port in the ring, and at least two tension filaments extending from the control handle through the flexible shaft and access port and extending around an inner core of the ring to separate anchor points, wherein an actuator on the control handle is configured to apply tension to the filaments and constrict the inner core by bringing at least two of the arcuate segments closer together.
2. The system of claim 1, wherein the peripheral shape is open and defines two free ends.
3. The system of claim 1, wherein the access port is located at one of the free ends.
4. The system of claim 1, wherein the access port is located on an atrial side of the ring spaced from one of the free ends.
5. The system of claim 1, wherein the actuator is a rotatable ring.
6. The system of claim 1, wherein there are three tension filaments extending around the inner core of the ring to different anchor points, and there is one actuator on the control handle for each tension filament.
7. The system of claim 1, wherein the anchor points are located so that arcuate segments adjacent at least the P2 and P3 regions of the posterior leaflet are independently adjustable.
8. The system of claim 1, wherein there are three tension filaments extending around the inner core of the ring to different anchor points, and there is one actuator on the control handle for each tension filament.
9. The system of claim 8, wherein the anchor points are located so that arcuate segments adjacent the P1, P2 and P3 regions of the posterior leaflet are independently adjustable.
10. The system of claim 1, wherein the arcuate segments comprise short core members that slide relative to curved struts passing through apertures therein.
11. The system of claim 1, wherein the arcuate segments comprise short core members separated by linearly or circumferentially compressible sections and both made of silicone.
12. A mitral annuloplasty ring and shape adjustment system for implant at a mitral annulus surrounding an anterior leaflet and a posterior leaflet, the mitral annulus being D-shaped with a straighter anterior aspect bordering an anterior leaflet opposite a more rounded posterior aspect bordering a posterior leaflet, and the posterior leaflet defining P1, P2 and P3 regions in CCW sequence looking from the atrial side, comprising: an annuloplasty ring defining a peripheral shape around a central aperture, the peripheral shape being D-shaped with a straighter anterior side adapted to be implanted adjacent the anterior leaflet opposite a more rounded posterior side adapted to be implanted adjacent the posterior leaflet, the annuloplasty ring having an inner core and a suture-permeable interface surrounding the inner core and extending around the peripheral shape, the inner core having a size-adjustable segment adjacent just the P2-P3 regions of the posterior leaflet that is linearly or circumferentially compressible to enable constriction of the ring while the P1 region and anterior side are not size-adjustable, the system including a proximal control handle having a flexible shaft extending therefrom, a distal end of the shaft being adapted to engage an access port in the ring, and at least one tension filament extends from the control handle through the flexible shaft and access port and extends around an inner core of the ring to an anchor point, wherein an actuator on the control handle is configured to apply tension to the filament and constrict the size-adjustable segment of the inner core.
13. The system of claim 12, wherein the peripheral shape is open and defines two free ends.
14. The system of claim 12, wherein the access port is located at one of the free ends.
15. The system of claim 12, wherein the access port is located on an atrial side of the ring spaced from one of the free ends.
16. The system of claim 12, wherein the actuator is a rotatable ring.
17. The system of claim 12, wherein there are three tension filaments extending around the inner core of the ring to different anchor points, and there is one actuator on the control handle for each tension filament.
18. The system of claim 12, wherein the size-adjustable segment comprises short core members that slide relative to curved struts passing through apertures therein.
19. The system of claim 12, wherein the size-adjustable segment comprises short core members separated by linearly compressible sections.
20. The system of claim 12, wherein the core members and linearly compressible sections are both made of silicone.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0020] Features and advantages of the present disclosure will become appreciated as the same become better understood with reference to the specification, claims, and appended drawings wherein:
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DETAILED DESCRIPTION
[0034] The right ventricle RV and left ventricle LV are separated from the right atrium RA and left atrium LA, respectively, by the tricuspid valve TV and mitral valve MV; e.g., the atrioventricular valves. Though correction of the mitral annulus is the primary focus of the present application, it should be understood that certain characteristics of the annuloplasty rings described herein may equally be used to treat the tricuspid valve TV, and thus the claims should not be constrained to the mitral ring unless expressly limited.
[0035] The term axis in reference to the illustrated annuloplasty rings, and other non-circular or non-planar rings, refers to a line generally through the centroid of the ring periphery when viewed in plan view. Axial or the direction of the axis can also be viewed as being parallel to the average direction of blood flow within the valve orifice and thus within the ring when implanted therein. Stated another way, an implanted mitral ring orients about a central flow axis aligned along an average direction of blood flow through the mitral annulus from the left atrium to the left ventricle. The plan views of the annuloplasty rings illustrated herein are as looking from the atrial side in the direction of blood flow. For the purpose of orientation, therefore, the atrial side of the ring is up in the ventricular site is down.
[0036]
[0037] The leaflets are shaped such that the line of coaptation resembles a smile that approximately parallels the posterior aspect of the mitral annulus MA. The anterior leaflet AL spans a smaller peripheral aspect around the mitral annulus MA than the posterior leaflet PL, but the anterior leaflet AL has a convex free edge that extends farther into the orifice defined by the mitral annulus MA. The posterior leaflet PL, on the other hand, has a generally concave free edge. Two commissuresan anterior commissure AC and a posterior commissure PC-generally defined the intersection of the line of coaptation between the two leaflets AL, PL and the mitral annulus MA. The posterior leaflet is divided into three scallops or cusps, sometimes identified as P1, P2, and P3, starting from the anterior commissure AC and continuing in a counterclockwise direction to the posterior commissure PC. Per convention, a major axis of the mitral annulus intersects both the first and third posterior scallops P1 and P3, approximately at the commissures AC, PC, and a minor axis intersects and generally bisects the middle posterior scallop P2. The anterior leaflet also features scallops or regions labeled A1, A2, and A3 as indicated in
[0038] As illustrated, the mitral annulus has a kidney or rounded D-shape around its periphery. The mitral anterior leaflet AL attaches to a somewhat straight anterior fibrous portion of the mitral annulus, which makes up about one-third of the total mitral annulus circumference. The anterior fibrous annulus, the two ends of which are called the fibrous left and right trigones LT, RT, forms part of the central fibrous skeleton of the heart. The arcuate muscular portion of the mitral annulus constitutes the remainder of the mitral annulus, and the posterior leaflet PL attaches thereto. The anterior commissure AC and the posterior commissure PC are located just posterior to each fibrous trigone.
[0039]
[0040] As seen in
[0041] The annuloplasty ring 30 may be three-dimensional with an upward bow in the posterior portion 32 as well as an upward bow in the anterior portion 34, as seen in
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[0043] The suture-permeable interface may include an elastomeric sleeve 42 closely surrounding the core and a fabric outer cover (not shown), for example, a polyethylene terephthalate (PET) fabric cover. In the preferred example the elastomeric sleeve 42, which may be silicone rubber, is generally tubular and molded to have a radially outwardly-extending flange 44 to facilitate suturing of the ring 30 to the mitral annulus. The ring 30 may be secured with sutures, staples, or other such devices to an inside fibrous ledge of the mitral annulus. In a typical procedure, the surgeon anchors an array of sutures through the annulus and then threads them through corresponding locations around the interface on the outside of the ring 30. The ring is parachuted down the suture array to be seated at the annulus before tying off the sutures.
[0044] In Degenerative Mitral Regurgitation, a primary cause for the onset of regurgitation is the dilation of the MV annulus. Typically the dilation of the annulus is localized in the P2 to P3 region. The need is to reshape the annulus to an appropriate size, to support the annulus in the surgically remodeled shape, and to reduce the time for implementation of the reinforcement ring/band.
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[0046] The cinch wire 54 may alternatively be connected to the curved strut 55 passing through the arcuate segments 53. The arcuate segments 53 slide over the curved strut 55 which is anchored into the core 51 on the side of the size-adjustable segment 52 opposite the free end 56a. The second curved strut 57 over which the arcuate segments 53 slide may be embedded into the core 51 on the other side of the size-adjustable segment 52 for stability.
[0047] The sizing of the ring 50 can be done using conventional methods, then during the application, cinched to optimize the repair. The ability to cinch the annulus in the P2-P3 region provides greater stability to the repair in this weakened location.
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[0049] Placement of the annuloplasty ring 50 is typically done on a stopped, flaccid heart, during which time it is difficult to fully evaluate the effectiveness of the ring/band in properly sizing the effective orifice of the MV, and to also optimize the coaptation of the leaflets to reduce or eliminate MR. Consequently, the final adjustment and optimization of the adjustable annuloplasty ring 50 can be accomplished on a beating heart with the delivery system 60, using echo guidance to optimize the ring adjustment. Sizing of the ring would follow conventional methods, being that the adjustable ring can be optimized a few millimeters in either direction. Once the optimization is complete, the ring 50 can be locked, the cinch wire 54 and delivery system 60 removed, and finally the hemostatic introducer 70 removed while simultaneously tightening the purse-string suture 72 to minimize bleeding and allow for final closure of the atrial wall incision.
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[0051] The tension filaments 88 emerge from the inner lumen at a port 90 located on an atrial side adjacent one free end 92 of the ring 80. Each tension filament 88 extends around the ring 80 a predetermined distance where it is secured to the core 84. Preferably, each tension filament 88 extends through a cable sheath which terminates short of the anchor point for the filament, such that tension on the filament compresses a discrete segment of the ring 80. For instance, one of the tension filaments 88 may extend all the way clockwise (CW) around the ring 80 to an anchor point at the distal end of the P1 segment. The associated cable sheath terminates and is secured to the core 84 at a proximal end of the P1 segment, so that tension on the filament compresses just the P1 segment independently. The same may be done independently with two other filaments 88 for the P2 and P3 segments to provide separate size adjustments of each of the three segments. In this way, greater size reduction is achievable, as well as the ability to adjust the band to correct for coaptation issues, and upsize/downsize the ring 80 in specific regions of the mitral annulus.
[0052] In addition to size adjustability in multiple discrete segments, the ring 80 has a flexible joint 94 at a posterior commissural marker to reduce the stress on the sutures/tissue in the portion of the ring which extends from the posterior commissural marker toward the posterior trigone. This is a location where dehiscence may occur due to excessive stresses. Positioning the port 90 on the ring 80 where adjustments are made allows the device to pass through the existing surgical incision without the need for additional insertion sites to be established. Closure of the wound in this location, following the removal of a tensioning device, can be accomplished with a running atrial closure suture. This location also has the advantage of not putting additional loads on the MV trigone during adjustment which may injure the MV.
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[0055] The core 122 and core members 126 has a hollow interior lumen through which passes a tension wire or filament 130. The filament 130 enters through a port 132 on an atrial side near one free end 134a of the ring 120 and extends to an anchor point 136 located beyond a midpoint of the ring 120; i.e., anywhere from a midpoint of the P2 segment around to second free end 134b. Pulling tension on the filament 130 pulls the anchor point 136 in a counter-clockwise (CCW) direction and causes the P2-P3 segment to compress linearly or circumferentially by virtue of the core members 126 sliding over the struts 128.
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[0062] While the foregoing is a complete description of the preferred examples, various alternatives, modifications, and equivalents may be used. Moreover, it will be obvious that certain other modifications may be practiced within the scope of the appended claims.