Systems and devices for heart valve repair - Patents.com

Abstract

The systems, devices, and methods disclosed herein may be provided for medical treatment involving transcatheter therapy and / or functional mitral regurgitation in a human heart. The treatment may include reshaping a native valve annulus (i.e., mitral or tricuspid valve) in the patient's heart. The systems, devices, and methods disclosed herein may include an anchor dispensing device (88) including a plurality of dispenser arms (98) configured to extend radially outward from a central portion of the dispensing device.

Description

[Technical field]

[0001] (CROSS-REFERENCE TO RELATED APPLICATIONS) This application claims the benefit of U.S. Provisional Patent Application No. 63 / 147,431, filed February 9, 2021, the entire contents of which are incorporated herein by reference. [Background technology]

[0002] Heart failure can occur when the ventricles of the heart become enlarged and dilated as a result of one or more of a variety of etiologies. Primary causes of heart failure include chronic hypertension, myocardial infarction, valvular insufficiency, and other dilated cardiomyopathies. With each of these conditions, the heart is forced to work excessively hard to provide the cardiac output required by the body during various demand conditions. Enlargement or dilation of the heart and ventricles can result from or be associated with these conditions.

[0003] A dilated or enlarged heart, especially a dilated or enlarged left ventricle, can significantly increase the tension and stress of the heart wall during both diastolic filling and systolic contraction, contributing to further dilation or enlargement of the ventricle. Furthermore, valvular dysfunction or regurgitation is a common comorbidity of congestive heart failure. As ventricular dilation increases, valvular function generally deteriorates, resulting in a volume overload state. Volume overload further increases ventricular wall stress, thereby advancing the dilatation process and further aggravating valvular dysfunction.

[0004] In heart failure, the size of the valve annulus (e.g., mitral valve annulus, tricuspid valve annulus, etc.) may increase while the leaflet area remains constant. This may decrease the coaptation area between the leaflets, which may ultimately result in valve leakage or regurgitation. Furthermore, in a normal heart, the size of the valve annulus shrinks during systole, aiding in valve coaptation. In heart failure, ventricular function is reduced and wall stress increases. These conditions tend to decrease the contraction of the valve annulus and distort the size of the valve annulus, often worsening valve regurgitation. Furthermore, as the ventricle expands, the papillary muscles (which are tethered to the leaflets by the chordae tendineae) may move radially outward and downward relative to the valve and to their normal position. However, during this movement of the papillary muscles, the length of the various chordae tendineae remains substantially constant, which may limit the leaflets' ability to fully close by applying tension to the leaflets. This condition is commonly referred to as "tethering of the chordae tendineae." The changes in the valve annulus and the changes in the papillary muscles may result in valve malfunction.

[0005] Therefore, improved systems, methods and devices for heart valve repair, and fixation systems generally, are desirable. Summary of the Invention [Means for solving the problem]

[0006] This summary is intended to provide some examples and is not intended to limit the scope of the invention in any way. For example, any features included in the examples of this summary are not required by the claims unless the claims explicitly recite those features. Also, features, components, steps, concepts, etc. described in the examples of this summary and elsewhere in this disclosure can be combined in various ways. Various features and steps described elsewhere in this disclosure can be included in the examples summarized herein.

[0007] The systems, devices, and methods disclosed herein can be used in medical treatments, including transcatheter treatments, such as the treatment of valvular regurgitation in the human heart. The treatments can include remodeling the native valve annulus of the patient's heart (i.e., the mitral or tricuspid valve), or another valve or structure in the human body. The systems, devices, and methods disclosed herein can further be used in other forms of medical treatments, and can be used for fixation to other parts of the patient's body.

[0008] The systems, devices, and methods disclosed herein can be utilized in minimally invasive procedures to access the heart without the need for a full sternotomy. Similarly, the systems, devices, and methods disclosed herein can be utilized in percutaneous or transcatheter procedures (e.g., transvascular, transfemoral, transdiaphragmatic, etc.) to access the heart and native valves without the need for a full sternotomy.

[0009] Implementations disclosed herein can include anchors that include anchor arms having a curved double hook shape. The anchors can be utilized in a fastening system that can be dispensed by an anchor dispensing device or can be utilized by a separate dispensing device.

[0010] For some applications herein, a fixation system is disclosed that includes a number of anchors, each configured to be fixed to tissue of a patient's body.

[0011] The fixation system can include one or more tethers or other contractile members (e.g., wires, lines, tethers, strings, ribbons, contraction wires, contraction lines, tension wires, tension lines, etc.) configured to connect the multiple anchors to one another and tighten the multiple anchors.

[0012] The fixation system can include an anchor dispensing device having a central portion and including a plurality of dispenser arms circumferentially spaced from one another, each configured to extend radially outward from the central portion to a distal end of each dispenser arm, each dispenser arm configured to dispense at least one of the plurality of anchors into tissue of the patient's body.

[0013] In some applications herein, a method is disclosed that includes positioning an anchor distribution device near a patient's native heart valve, the anchor distribution device having a central portion and including a plurality of dispenser arms circumferentially spaced from one another and extending radially outward from the central portion to a distal end of each dispenser arm.

[0014] The method may include dispensing a plurality of anchors from a plurality of dispenser arms into tissue surrounding the patient's native heart valve.

[0015] The method can include tensioning one or more tethers or other contraction members (e.g., wires, lines, tethers, strings, ribbons, contraction wires, contraction lines, tension wires, tension lines, etc.) that connect the multiple anchors and tighten the multiple anchors.

[0016] The methods and processes described above can be performed in live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and the like.

[0017] The features and advantages of the systems, apparatus, and methods as disclosed herein will become better understood and appreciated with reference to the specification, claims, and accompanying drawings. [Brief description of the drawings]

[0018] [Figure 1] FIG. 1 shows a perspective view of an anchor according to an application of the present disclosure. [Diagram 2]FIG. 2 illustrates a front view of the anchor shown in FIG. 1 positioned within a dispenser arm in an undeployed or linearized configuration, in accordance with an application of the present disclosure. [Diagram 3] 3 shows a perspective view of the anchor shown in FIG. 1 with the spacer body rotated from the position shown in FIG. [Figure 4] FIG. 4 shows a side view of the anchor shown in FIG. 3 with the spacer body shown in cross section. [Diagram 5] FIG. 5 shows a side schematic view of multiple anchors implanted in tissue. [Figure 6] FIG. 6 illustrates a side schematic view of multiple anchors shown in FIG. 5 in a clamped, tensioned, and / or contracted state. [Figure 7] FIG. 7 shows a side cross-sectional view of a tensioning and cutting mechanism according to an application of the present disclosure. [Figure 8] FIG. 8 illustrates a side cross-sectional view of the operation of the cutting mechanism of FIG. [Figure 9] FIG. 9 shows a side cross-sectional view of the tensioning and cutting mechanism shown in FIG. 7 pulled out of the lock. [Figure 10] FIG. 10 shows a side view of an anchor distribution device with multiple shafts shown in cross section. [Figure 11] FIG. 11 illustrates a rear view of the anchor distribution device shown in FIG. [Figure 12] 12 illustrates a distal perspective view of a portion of the anchor delivery device shown in FIG. [Figure 13] 13 illustrates a proximal perspective view of a portion of the anchor delivery device shown in FIG. [Figure 14] FIG. 14 illustrates a side perspective view of the anchor dispensing device shown in FIG. 10 with the dispenser arms extending radially outward. [Figure 15] 15 illustrates a side perspective view of the anchor dispensing device shown in FIG. 10 with the dispenser arms extending radially outward further than shown in FIG. [Figure 16]FIG. 16 shows a side cross-sectional view of a dispenser arm having an anchor and push body positioned therein, according to an application of the present disclosure. [Figure 17] FIG. 17 shows a side cross-sectional view of a dispenser arm with the anchor and push body slid from the position shown in FIG. 16 in accordance with an application of the present disclosure. [Figure 18] FIG. 18 illustrates a side perspective view of the anchor dispensing device shown in FIG. 10 with the dispenser arms extending radially outward and having anchors positioned therein. [Figure 19] FIG. 19 illustrates a side perspective view of the anchor dispensing device shown in FIG. 10 with the dispenser arms extending radially outward and having anchors dispensed therefrom. [Figure 20] FIG. 20 shows a side schematic view of a dispenser arm contacting a wall. [Figure 21] FIG. 21 shows a schematic diagram of an anchor delivery device entering a patient's body, according to an application of the present disclosure. [Figure 22] FIG. 22 shows a schematic superior view of the left atrium and mitral valve with an anchor distribution device positioned within the left atrium. [Figure 23] FIG. 23 illustrates a top schematic view of the left atrium and mitral valve shown in FIG. 22 with the dispenser arms of the anchor dispensing device extending radially outward. [Figure 24] FIG. 24 shows a schematic top view of the left atrium and mitral valve shown in FIG. 22 with anchors distributed around the periphery of the mitral valve. [Diagram 25] FIG. 25 shows a schematic top view of the left atrium and mitral valve shown in FIG. 22 with the anchors tightened from the position shown in FIG. [Figure 26] FIG. 26 shows a side view of an anchor, contraction member, and spacer body according to an application of the present disclosure. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0019] Various aspects of the present disclosure generally relate to systems, devices, and methods for treating medical and / or cardiac conditions, including, by way of example, valve insufficiency (including valve regurgitation, which may include mitral or tricuspid regurgitation). The systems, devices, and methods may be adapted for percutaneous or transcatheter medical care without the need for full-scale open-chest surgery. However, in some applications, more invasive delivery methods may be utilized. The systems, devices, and methods may be utilized to repair heart valves by deforming the annulus of the heart, including the mitral or tricuspid annulus, among other applications in other cardiac structures or other structures of the body.

[0020] 1 illustrates an application of an anchor 10 according to the present disclosure. The anchor 10 may include a first anchor arm 12 and a second anchor arm 14. The first anchor arm 12 may include a distal end including a piercing tip 16 and may extend to a proximal portion 18 located at a central portion 20 of the anchor 10. Similarly, the second anchor arm 14 may include a piercing tip 22 and may extend to a proximal portion 24 located at the central portion 20 of the anchor 10.

[0021] The central portion 20 of the anchor 10 may comprise a junction that joins the proximal portions 18, 24 of the first anchor arm 12 and the second anchor arm 14 together. The central portion 20 may comprise a linear body that may extend along an axis 39 (marked in FIG. 4). The anchor arms 12, 14 may be joined together at the central portion 20 of the anchor 10 and each may extend outwardly from the central portion 20 to the tips 16, 22 of the respective anchor arms 12, 14. The anchor 10 may be configured to secure to tissue in a patient's body.

[0022] The anchor 10 is shown in FIG. 1 in a deployed (or expanded) configuration, with the anchor 10 having an expanded shape. Each anchor arm 12, 14 may form a curved hook that extends outward from each other and from a central portion 20 of the anchor 10. Each anchor arm 12, 14 may extend in opposite directions outward from the central portion 20 of the anchor 10 away from the other arm in the same plane (coplanar) to the tip 16, 22 of the respective anchor arm 12, 14. Each anchor arm 12, 14 may have a convex curvature that curves in the distal direction. Each anchor arm 12, 14 may have a "U" shape or other shape as desired. The anchor 10 may have a double curved hook configuration.

[0023] The anchoring arms 12, 14 may be shaped to extend symmetrically outwardly from the central portion 20 and may have the same shape as one another. In some applications, the shapes of the anchoring arms 12, 14 in the deployed configuration may differ from one another.

[0024] The anchor arms 12, 14 may be shaped to have the same width from the central portion 20 of the anchor 10 to the respective piercing tips 16, 22 of each anchor arm 12, 14. The widths 26, 28 of each anchor arm 12, 14 are marked in FIG. 4. Each width 26, 28 may be set based on the desired fixation width of each anchor arm 12, 14 into tissue. For example, the widths 26, 28 may be set at 5 millimeters to 10 millimeters in some applications, or may be about 8 millimeters in some applications, or may be more or less as desired. Additionally, the depths 30, 32 of each anchor arm 12, 14 from the respective piercing tips 16, 22 (marked in FIG. 4) may also be set a desired amount. For example, the depths 30, 32 may be 3 to 6 millimeters, or may be about 4 or 5 millimeters in some applications, or may be a greater or lesser amount. The radius of curvature of each anchor arm 12, 14 may be the same and may be set a desired amount. For example, the radius of curvature may be 5-10 millimeters, or in some applications may be about 8 millimeters, or a greater or lesser amount. The thickness 43 of the arms 12, 14 may be 0.3-0.10 millimeters, or in some applications may be about 0.5-0.7 millimeters, or a greater or lesser amount. In some applications, the configuration and dimensions of the anchor arms 12, 14 can vary as desired.

[0025] 1, anchor arms 12, 14 may be flat and may be stamped or otherwise cut (e.g., laser cut) from a flat piece of material. Anchor arms 12, 14 of anchor 10 may accordingly retain the flat shape of the material from which they are formed. The thickness of anchor arms 12, 14 may be 0.2 to 0.5 millimeters in some applications, and may be about 0.4 millimeters in some applications, or may be a greater or lesser amount.

[0026] Each piercing tip 16, 22 may be configured as a sharp tip configured to pierce tissue or other material as desired. Although the piercing tips 16, 22 and anchor arms 12, 14 may be configured to penetrate and anchor in tissue, in some applications the anchor 10 may also be anchored in other materials.

[0027] Each anchor arm 12, 14 may be biased to a deployed or expanded configuration, as shown in Figure 1. In some applications, each anchor arm 12, 14 may be configured to move from an undeployed (or unexpanded, linearized, or straightened) configuration to the deployed or expanded configuration. For example, each anchor arm 12, 14 may be configured to bias outwardly from a linearized shape in the undeployed configuration to an expanded shape, as shown in Figure 1.

[0028] 2, for example, shows the anchor arms 12, 14 in an undeployed (or unexpanded, linearized, or straightened) configuration. The anchor 10 is shown positioned within a channel of a dispenser arm 98, which holds the anchor arms 12, 14 in the undeployed configuration, according to an application of the present disclosure. The anchor arms 12, 14 have a linearized shape, extend axially relative to one another, and are positioned adjacent to one another. The piercing tips 16, 22 both extend distally and along the axis of the anchor 10, and are positioned adjacent to one another. A portion of the anchor arms 12, 14 between the tips 16, 22 and the proximal portions 18, 24 further extend axially relative to one another along the axis of the anchor 10. The axes of the anchor arms 12, 14 are parallel to one another. The anchor 10 is configured such that a distal force applied to the anchor 10 causes both piercing tips 16, 22 to extend in the same distal direction, and therefore pierce tissue or other material in the same direction as desired. Biasing of the anchor arms 12, 14 to a deployed or expanded configuration causes the anchor arms 12, 14 to deflect outwardly upon piercing the tissue or other material, and therefore expand within the tissue or other material. The anchor arms 12, 14 can then form the double-curved hook shape shown in FIG. 1 within the tissue or other material.

[0029] In some applications, the anchor 10 and anchor arms 12, 14 may be self-expandable and configured to self-expand from the undeployed configuration shown in FIG. 2 to the deployed configuration shown in FIG. 1. The anchor 10 and anchor arms 12, 14 may be formed in the configuration shown in FIG. 1 and biased toward such shape. In some applications, the anchor 10 and anchor arms 12, 14 may be made from a shape memory material configured to expand to the deployed configuration shown in FIG. 1. For example, the anchor 10 and anchor arms 12, 14 may be made from a Nitinol material or other shape memory material. In other applications, the anchor 10 and anchor arms 12, 14 may be made from another form of material (e.g., a spring-biased material) that may be configured to bias toward the deployed configuration shown in FIG. 1.

[0030] In some applications, the anchor arms 12, 14 may be configured to be retracted back into the undeployed (or unextended, linearized, or straightened) configuration shown in Figure 2. For example, the anchor 10 may be retracted into the dispenser arm shown in Figure 2, or may be linearized, such as after being partially dispensed from the dispenser arm 98.

[0031] Other configurations of anchors and anchor arms may be utilized in accordance with various applications herein. For example, a greater number of anchor arms (e.g., at least three, four, or a greater number) may be utilized in anchors in accordance with various applications herein. In some applications, at least two anchor arms may be utilized. Additionally, the shape of the anchor arms may vary in some applications to include angled and other curved configurations. The shape of the anchor arms may lack symmetry in some applications. Thus, the configuration of the anchors utilized in some applications herein may vary as desired.

[0032] Referring again to FIG. 1 , spacer body 34 may be coupled to anchor 10. Spacer body 34 is pivotally coupled to anchor 10, which includes a pivot 36 about which spacer body 34 is configured to pivot. Pivot 36 may be located at central portion 20 of anchor 10. Spacer body 34 may include a linking body 38, which pivotally couples to pivot 36 and may be configured to position spacer body 34 offset from a plane in which anchor 10 extends. As shown in FIG. 1 , linking body 38 may extend proximally from proximal end 37 of anchor 10, and may form a plateau where end 40 of spacer body 34 is positioned on a plane offset from anchor 10.

[0033] In some applications, the spacer body 34 may comprise a tube having a first end 42 (or proximal end), a second end 40 (or distal end), and a length 48 (marked in FIG. 4) therebetween. The first end 42 and the second end 40 may each include an opening leading to an interior channel 44 (marked in FIG. 4) configured to pass one or more contraction members 46 (e.g., wires, lines, tethers, strings, ribbons, contraction wires, contraction lines, tension wires, tension lines, etc.). The contraction members 46 may be configured as tethers or other forms of contraction members 46, as desired.

[0034] The spacer body 34 may be configured to pivot about a pivot 36 between a vertical or upright configuration in which the spacer body 34 extends axially with the central portion 20 of the anchor 10, as shown in FIG. 1, and a horizontal or rotated configuration in which the spacer body 34 extends transversely to an axis 39 of the central portion 20. The horizontal or rotated configuration is shown in FIG. 3. In the horizontal or rotated configuration, the spacer body 34 may extend at an angle 41 with respect to the axis 39 of the central portion 20, as shown in FIG. 4, which may be 90 degrees or another angle as desired. The spacer body 34 may extend along an axis 45 (marked in FIG. 4) that extends transversely or perpendicularly to the axis 39 of the central portion 20. The spacer body 34 may cover one width 28 of the anchor arm 14 and may be positioned proximate one of the tips 22 in the horizontal or rotated configuration, as shown in FIG. 4.

[0035] The spacer body 34 may be positioned in an upright configuration and extends axially with the anchor arms 12, 14 in an undeployed configuration, as shown in FIG 2. The spacer body 34 may extend axially relative to the anchor 10 when the anchor 10 is in an undeployed configuration. The spacer body 34 may extend axially with the anchor arms 12, 14 to allow for ease of deployment from a dispenser arm 98, as shown in FIG 2. Once the anchor 10 and spacer body 34 are deployed from the dispenser arm, the spacer body 34 may be rotated to a horizontal or rotated configuration, as shown in FIG 3.

[0036] The spacer body 34 may be configured to space adjacent anchors 10 from one another as the anchors 10 are tightened. The spacer body 34 may be configured to extend over or otherwise engage one or more contraction members 46 (e.g., wires, lines, tethers, strings, ribbons, contraction wires, contraction lines, tension wires, tension lines, etc.). With reference to FIG. 4 , the contraction members 46 may pass through channels 44 in the anchors 10 and may be coupled to adjacent anchors. As the contraction members 46 are tightened, the first ends 42 of the spacer bodies 34 may be drawn toward and contact the second ends 40 of the adjacent spacer bodies 34. Similarly, the second ends 40 of the spacer bodies 34 may contact the first ends 42 of the adjacent spacer bodies 34. In this manner, the length 48 of the spacer body 34 may determine the distance between adjacent anchors 10 as the contraction members 46 are tightened. The offset of the spacer body 34 from the anchor 10 allows the second end 40 of the spacer body 34 to directly contact the first end 42 of the adjacent spacer body 34. The length 48 can be set as desired. For example, in some applications, the length can be between 5 millimeters and 10 millimeters, or a greater or lesser amount. In some applications, the length can be about 7 millimeters. The various spacer bodies used in the fixation system can have different lengths. For example, one spacer body can be about 7 millimeters in length and another spacer body can be about 9 millimeters in length. Various lengths can be utilized as desired.

[0037] 4, the first end 42 of the spacer body 34 may be configured to protrude from the piercing tips 22 of the anchor 10. In this manner, space can be provided for fastening the anchors 10 together such that the spacer bodies 34 contact one another and provide spacing between adjacent piercing tips 16, 22 of the anchor 10. In other applications, other configurations of the spacer body 34 may be utilized.

[0038] One or more contraction members 46 (e.g., wires, lines, tethers, strings, ribbons, contraction wires, contraction lines, tension wires, tension lines, etc.) may be configured to connect the multiple anchors 10 together and tighten the multiple anchors 10. The one or more contraction members 46 may be configured to pass through the channel 44 of the spacer body 34 as desired. The contraction members 46 may be configured as wires, lines, or cords, or other forms of contraction members as desired. The contraction members 46 may be configured to be flexible, yet have sufficient strength to resist tension applied to the contraction members 46. In some applications, a single contraction member may be utilized, or multiple contraction members may be utilized as desired.

[0039] 5 shows an exemplary diagram of multiple anchors 10 distributed within tissue 50. The anchors 10 may be distributed adjacent to one another and may penetrate the tissue 50 in an undeployed or linearized configuration as shown in FIG. 2. The anchors 10 may then expand within the tissue 50 to a deployed configuration as shown in FIG. 1. The anchors 10 may self-expand into the deployed configuration as shown in FIG. 1. The anchor arms 12, 14 may be completely covered by the tissue 50, with the central portion 20 of the anchor 10 positioned above the surface of the tissue 50. In this manner, the pivot 36 and the spacer body 34 may be positioned above the surface of the tissue 50.

[0040] The anchors 10 may be distributed within tissue 50 with spacing 52 between the anchors 10. The spacing 52 may be between central portions 20 of the anchors 10. Spacing 51 may be provided between adjacent piercing tips 16, 22 of the anchors 10. In some applications, the spacing may be set so that adjacent piercing tips overlap one another, or the tips 16, 22 of adjacent anchors 10 may be spaced apart from one another by spacing 51, as shown in FIG.

[0041] The spacing 52 can be set as desired. For example, in some applications the spacing can be between 10 millimeters and 20 millimeters, or a larger or smaller amount, as desired. In some applications the spacing can be spaced about 15 millimeters apart. The spacing can be set to provide a desired contraction to the tissue into which the anchors are delivered in some applications.

[0042] The anchors 10 may be dispensed into tissue 50 with the spacer body 34 positioned in an upright configuration, as shown in FIG. 1 . One or more contraction members 46 may pass through the interior channel of the spacer body 34 and connect the anchors 10 to one another. Thus, an anchor 10 may be dispensed connecting all of the anchors 10 and the contraction member 46 passing through the spacer body 34. Such a configuration is shown, for example, in FIG. 19 . The distal end 54 of the contraction member 46 may be coupled to a stopper 56 that is sized larger than the channel of an adjacent spacer body 34 and configured to contact the second end 40 of the adjacent spacer body 34. In this manner, the stopper 56 may prevent the end 54 of the contraction member 46 from passing through an adjacent spacer body 34 and resist a clamping force applied to the contraction member 46 from the opposing proximal portion 58 of the contraction member 46.

[0043] 5, which may occur by partially tightening the retraction member 46, pivoting the spacer body 34 horizontally relative to the surface of the tissue 50. The most proximal anchor 60 may be configured similarly to the remaining anchors 10. However, the most proximal anchor 60 may include an opening 62 for the retraction member 46 to pass through, and adjacent anchors 10 may include a spacer body 34 to space them from the anchor 60, so may not require a spacer body 34.

[0044] A proximal portion 58 of the contraction member 46 can be coupled to a tensioning mechanism (shown in FIG. 7) that can be configured to tension one or more contraction members 46 (e.g., wires, lines, tethers, strings, ribbons, contraction wires, contraction lines, tension wires, tension lines, etc.). Thus, the anchor 10 can include a distal anchor (the right-most anchor shown in FIG. 5), a proximal anchor 60, and one or more intermediate anchors 10 (between the distal anchor and the proximal anchor 60 shown in FIG. 5). The contraction member 46 can be tensioned at the proximal anchor 60.

[0045] The lock 64 may be positioned near the proximal portion 58 of the contraction member 46 and the anchor 60. The lock 64 may be configured to lock one or more of the contraction members 46 in a tensioned configuration. The lock 64 may be configured as a latching lock that may allow movement of the lock 64 in a distal direction and prevent movement of the lock 64 in a proximal direction. In this manner, the lock 64 may include a locking surface 66 configured to lock against the proximal portion 58 of the contraction member 46 and may prevent the contraction member 46 from being pulled distally away from the lock 64. In some applications, various forms of locks may be utilized, including ratcheting locks. In some applications, a user operated or set lock or a resettable lock may be utilized to release and set the lock as desired. Such a feature may be beneficial if excessive tension in the contraction members is determined during a procedure and the lock must be reset, or if there is another need to release and / or reset the lock.

[0046] Once the anchor 10 is deployed to a desired location, the anchor 10 can be tightened by tightening the contraction member 46. For example, a tensioning mechanism as shown in FIG. 7 can be utilized to tighten the contraction member 46. The contraction member 46 can be retracted proximally to tighten the contraction member 46, causing the stopper 56 to abut the end 40 of an adjacent spacer body 34 and apply a proximal force to the anchor 10 and spacer body 34. The spacer body 34 can then move proximally toward an adjacent spacer body 34 and contact the end 40 of another adjacent spacer body 34. Such movement can reduce the spacing 52 between the anchors 10. The spacing between the anchors 10 can continue to decrease, thereby tightening the anchors 10 together.

[0047] A resistance force may be applied to the lock 64 and the anchors 60 by a tensioning mechanism. The resistance force may be in a distal direction to prevent the anchors 60 from moving proximally after the contraction member 46 is tightened. Such a resistance force may further allow the spacing 52 between the anchors 10 to decrease.

[0048] FIG. 6, for example, shows the anchors 10 in a tightened state. The spacing 68 between the anchors 10 has been reduced from the spacing 52 shown in FIG. 5. Additionally, the spacing 67 between the tips of the anchor arms has been reduced from the spacing 51 shown in FIG. 6. The spacer bodies 34 contact each other and define the spacing between the anchors 10. The lock 64 can be pressed against the anchor 60 and locked to the proximal portion 58 of the contraction member 46 to hold the contraction member 46 in a tensioned configuration. The locking surface 66 can hold against the contraction member 46. The proximal portion 58 of the contraction member 46 can be cut using a cutting mechanism to reduce the amount of the contraction member 46 that extends proximally from the proximal anchor 60 and from the lock 64.

[0049] The configuration of the anchor 10 shown in Figures 5 and 6 can beneficially provide improved fixation of the anchor 10 to tissue. Additionally, the dual curved hook configuration of the anchor arms 12, 14 can improve the grip of the anchor 10 to the tissue and reduce the total number of anchors 10 required to retract the underlying tissue 50. The use of the anchors 10 and fixation system can be utilized in a variety of ways, including, for example, reducing the size of the valve annulus as shown in Figures 24 and 25. The anchors 10 can each be configured to secure to tissue within the patient's heart surrounding a native valve. The anchors 10 can be positioned within a curve around the native heart valve and used to reduce the size of the valve annulus. The valve can be a mitral or tricuspid valve, or other valve in some applications. Other uses can be provided, including general retraction or compression of tissue. Variations in the use of the anchors 10 and fixation system can be utilized.

[0050] The anchor 10 disclosed herein can be utilized alone, without the other components disclosed herein. Additionally, the fixation system including the anchor 10, spacer body, and one or more contraction members can be utilized only without the other components disclosed herein. For example, the anchor 10 can be utilized without the use of the anchor dispensing device 88 disclosed herein.

[0051] FIG. 7 shows a side cross-sectional view of a tensioning mechanism and a cutting mechanism that may be utilized according to various applications herein. The tensioning mechanism may include a pressing surface 70 (marked in FIG. 9) that may be configured to apply a force to a portion of the fixation system, specifically the lock 64 or anchor 60 shown in FIG. 5. The pressing surface 70 may comprise a distal surface of the tensioning mechanism. The tensioning mechanism may include a shaft 72, and the pressing surface 70 may be a distal surface of the shaft 72. The shaft 72 may comprise a shaft of a catheter configured to pass through a patient's body. The shaft 72 may have a distal end 74 that includes the pressing surface 70, and may have a proximal portion 76 that may be configured to be positioned outside the patient's body during operation of the tensioning mechanism. The proximal portion 76 may be accessible by a user and configured to move during a treatment procedure. The shaft 72 may be configured to transmit a pressing force from the proximal portion 76 of the shaft 72 to the distal end 74 and the pressing surface 70 of the shaft 72.

[0052] In some applications, shaft 72 may include a sheath extending around channel 78. Channel 78 may be configured to pass retraction member 46, with a proximal portion 58 of retraction member 46 accessible at proximal portion 76 of shaft 72. Proximal portion 58 may be accessible by a user and configured to be moved (e.g., pulled distally) from outside the patient's body during a treatment procedure.

[0053] In some applications, the cutting mechanism may be coupled to the tensioning mechanism. The cutting mechanism may be configured to cut one or more contraction members 46 in a tensioned configuration. For example, as shown in FIG. 7, the cutting mechanism may include a cutting surface 80 positioned at a distal end of a cutter 82. The cutter 82 may include a shaft having a proximal portion 84 that extends into the channel 78, for example, and is accessible to be manipulated by a user. The proximal portion 84 may be accessible by a user and configured to be moved during a treatment procedure.

[0054] Cutter 82 may be configured to bias against an angled surface 86 of shaft 72, which may bias cutting surface 80 against contraction member 46 to cut contraction member 46 as cutter 82 advances distally. In some applications, the cutting mechanism may have another configuration and may not be located within the shaft of the tensioning mechanism. In some applications, the cutting mechanism may be a separate device including a shaft or catheter configured to cut contraction member 46 in a tensioned configuration. The configuration of cutter 82 may further vary from the configuration shown in FIG. 7.

[0055] In operation, the tensioning mechanism can be advanced distally along the proximal portion 58 of the contraction member 46. The tensioning mechanism can be advanced after the anchor 10 has been dispensed to the desired implantation site or can be in place during distribution of the anchor 10. The tensioning mechanism can be advanced such that the pushing surface 70 presses against the lock 64, advancing the lock 64 along the contraction member 46 toward the proximal anchor 60. The tensioning mechanism can be advanced distally until the lock 64 presses against the anchor 60.

[0056] The proximal portion 58 of the contraction member 46 may be accessible to the user and therefore may be drawn proximally as the pushing surface 70 advances distally. For example, the user may grasp the proximal portion 76 of the tensioning mechanism and advance the proximal portion 76 distally or hold the proximal portion 76 in place as the contraction member 46 is pulled proximally. A tension measuring device may be utilized, for example, to determine whether a desired amount of tension is applied to the contraction member 46 and whether the anchor 10 shown in FIG. 6 is tightened to a desired amount. Visualization of the anchor 10 via fluoroscopy and / or echocardiography, among other forms of visualization, may alternatively or additionally be utilized in combination with a tension measuring device to determine whether the anchor 10 is tightened to a desired amount. The tension of the contraction member 46 may be increased until the desired amount of tension is provided. In applications in which anchor 10 is deployed in a heart valve during beating heart surgery, measurements of the heart valve's operation (e.g., flow and / or pressure gradients) can be made to determine whether the desired tension is applied to contractile member 46.

[0057] Lock 64 may be configured to resist distal movement of contraction member 46, such that once the tension is set to a desired amount, the tension in contraction member 46 can be locked. Once tension is set, a cutting mechanism can be utilized to cut proximal portion 58 of contraction member 46. Proximal portion 84 of cutter 82 can be advanced distally, for example, to slide cutting surface 80 over angled surface 86 and cut contraction member 46. FIG. 8, for example, illustrates cutter 82 cutting contraction member 46.

[0058] With the lock 64 maintaining tension on the contraction member 46 and the proximal portion 58 of the contraction member 46 being severed, the shaft 72 of the tensioning mechanism and the cutter 82 of the cutting mechanism, as well as the remaining proximal portion of the contraction member 46, may be retracted proximally and out of the patient's body. The lock 64 may remain in place with the anchor 10 tightened and the contraction member 46 locked in the tensioned configuration.

[0059] In some applications, other forms of tensioning and cutting mechanisms can be utilized as desired. The tensioning and cutting mechanisms can be separate from one another or combined as desired.

[0060] The tensioning mechanism and cutting mechanism disclosed herein may each be utilized alone, without the other components disclosed herein.

[0061] 10 illustrates an application of an anchor distribution device 88 that may be utilized in accordance with the applications herein. The anchor distribution device 88 may include an elongate shaft 90 having a proximal end 92 (marked in FIG. 21) and a distal end 93 (marked in FIG. 10). The anchor distribution device 88 may have a distal end 94 with a distribution head 96 positioned at the distal end 93 of the elongate shaft 90. The distribution head 96 may be configured to distribute a plurality of anchors 10 to a portion of a patient's body.

[0062] The dispense head 96 of the anchor dispenser apparatus 88 may include a central portion 95 having a central axis 97. The dispense head 96 may include a plurality of dispenser arms 98. Each dispenser arm 98 may be circumferentially spaced from one another. Each dispenser arm 98 may be positioned about the central axis 97 of the central portion 95.

[0063] Each dispenser arm 98 may have a proximal portion 100 having a proximal end and a distal portion 102 including a distal end. Each dispenser arm 98 may be an elongated linear body and may extend longitudinally along a central axis 97 from a proximal end to a distal end of the respective dispenser arm 98 in the undeployed (or unextended) configuration shown in FIG. 10. Each dispenser arm 98 may have an axis that extends parallel to the axis of each other dispenser arm 98 and parallel to the central axis 97 in the undeployed configuration shown in FIG. 10. Each dispenser arm 98 may extend distally from the elongated shaft 90 to a distal end of the respective dispenser arm 98 in the undeployed (or unextended) configuration shown in FIG.

[0064] A proximal portion 100 of each dispenser arm 98 may be pivotally connected to the central portion 95 of the anchor dispensing apparatus 88. A pivot 103 of each dispenser arm 98 (marked in FIG. 13 ) may connect the proximal portion 100 to the central portion 95.

[0065] A distal portion 102 of each dispenser arm 98 may include a distal end configured to have an anchor 10 dispensed therethrough. Each distal end may include an opening 105 (marked in FIG. 12 ) for the anchor 10 to be dispensed. Additionally, each proximal end may include an opening 101 (marked in FIG. 13 ) through which a respective push body 110 is configured to pass and push the anchor 10 from the respective dispenser arm 98.

[0066] Each dispenser arm 98 may include a channel 104 for the anchor 10 to slide within. Additionally, the spacer body 34 may be coupled to the anchor 10 and may slide along with the anchor 10. The channel 104 may be configured to hold the anchor 10 and the spacer body 34. The channel 104 may be configured such that the anchor 10 and the spacer body 34 are passed through in an undeployed or linearized configuration, for example, as shown in FIG. 2. The anchor 10 and the spacer body 34 may slide distally along the channel 104 dispensed from a distal end of the respective dispenser arm 98, thereby allowing the anchor 10 to expand into a deployed or expanded configuration within the patient's tissue or other material.

[0067] Each dispenser arm 98 can be configured to hold the anchors 10 and spacer body 34 in a linearized configuration within the channel 104. Each dispenser arm 98 can be configured to dispense at least one of the multiple anchors 10 into tissue of the patient's body.

[0068] 12, for example, shows an enlarged view of a distal portion of channel 104. Dispenser arm 98 may include a retaining lip 107 that extends over channel 104, with a slot 109 extending between lip 107 and along channel 104 for passage of spacer body 34. Channel 104 may be surrounded by a sidewall 111 that extends along channel 104 and is raised from a base wall 113.

[0069] In some applications, each dispenser arm 98 can hold an anchor 10 in an undeployed or linearized configuration. Sidewall 111 can hold anchor 10 in an undeployed or linearized configuration, for example, as shown in FIG.

[0070] In some applications, the configuration of the dispenser arm 98 and the channel may vary. For example, in some applications, the anchor 10 may be held outside of the channel 104 and still slide relative to the channel 104 and the dispenser arm 98. Additionally, in some applications, the dispenser arm 98 may dispense the anchor 10 by holding the anchor 10 at a distal end of the arm 98 and delivering the anchor 10 from the distal end. For example, the anchor 10 may be pressed against a surface by the dispenser arm 98 in order for the anchor 10 to be dispensed. Various forms of dispensing by the dispenser arm 98 may be provided in some applications.

[0071] 10, one or more contraction members 46 (e.g., wires, lines, tethers, strings, ribbons, contraction wires, contraction lines, tension wires, tension lines, etc.) may pass through the spacer body 34 in a zigzag fashion from the proximal end 42 of the spacer body 34 to the distal end 40 of an adjacent spacer body, then through the spacer body 34 to the proximal end 42, then to the distal end 40 of an adjacent spacer body. Thus, the one or more contraction members 46 may extend about a central axis 97 and about dispenser arms 98 and may be routed in a configuration for deployment. FIGS. 18 and 19, for example, show anchors 10 being dispensed with contraction members 46 extending between spacer bodies 34.

[0072] The central portion 95 of the anchor distribution device 88 may include a central support 106 and may include a slide body 108. The central support 106 is shown in partial cross section in FIG 10 and the slide body 108 is shown in cross section in FIG 10. A perspective view of the application of the central support 106 and slide body 108 is shown in FIG 14, with the push body 110 and steerable shaft 112 not shown.

[0073] The slide body 108 may be configured to slide relative to the central support 106. The proximal portion 100 of the dispenser arm 98 may be pivotally coupled to the slide body 108, such that the proximal portion 100 may be pivotally coupled to the central support 106 via a coupling to the slide body 108. In some applications, for example, as shown in FIG. 10, the slide body 108 may comprise a shaft in the form of a sheath that extends around the central support 106, or may comprise a ring or other form of body that extends around the central support 106. The slide body 108 may extend along the length of the elongated shaft 90 of the anchor dispensing device 88 and may have a proximal portion accessible from outside the patient's body. For example, the proximal portion may extend into a handle 130 shown in FIG. 21.

[0074] The central support 106 may include a shaft that extends within the slide body 108 and along the length of the elongated shaft 90 of the anchor distribution device 88. The central support 106 may have a proximal portion that is accessible from outside the patient's body. For example, the proximal portion may extend to a handle 130, shown in FIG.

[0075] The anchor dispensing apparatus 88 may further include a dispensing mechanism configured to dispense the plurality of anchors 10 from the plurality of dispenser arms 98. The dispensing mechanism may include one or more push bodies 110 that may be configured to push the anchors 10 distally from the plurality of dispenser arms 98. The push bodies 110 may pass through the channels 104 of the respective dispenser arms 98. The push bodies 110 may push the anchors 10 distally from the channels 104. The push bodies 110 may comprise, for example, a wire that passes through a proximal opening 101 (shown in FIG. 13 ) of the dispenser arms 98 and extends distally through the channels 104. The wire may comprise a flexible material and may comprise a shape memory material, such as Nitinol or another form of shape memory material. In some applications, other materials may be utilized for the push bodies 110.

[0076] A proximal portion of the push body 110 may extend along the elongate shaft 90 and may be accessible at the proximal end of the elongate shaft 90 and outside the patient's body. For example, the proximal portion may extend to a handle 130 shown in FIG.

[0077] The push body 110 may be positioned around the slide body 108 as shown in FIG. 10 or may have another configuration as desired. Multiple push bodies 110 may extend around the slide body 108 and along the length of the elongate shaft 90, with one push body 110 per dispenser arm 98 or another number as desired. In some applications, the configuration and operation of the dispensing mechanism may vary as desired, and other forms of dispensing, such as, for example, a rotatable drive or a geared conveyor, may be used to dispense the anchors. Electrical (or electromagnetic) dispensing may be used in some applications.

[0078] The anchor distribution device 88 may further include a steerable shaft 112 that may form an outer sheath for the elongate shaft 90. The outer sheath may extend over the push body 110, slide body 108, and central support 106 of the elongate shaft 90. The steerable shaft 112 may include pull wires 114, etc., that may steer and manipulate the steerable shaft 112, as desired. The steerable shaft 112 may allow the dispensing head 96 to deflect in a single plane, or in some applications, may deflect in multiple planes, including at least two planes. The steerable shaft 112 may allow the dispensing head 96 to be oriented as desired relative to an implantation site, such as a native heart valve, including a native mitral or tricuspid valve. In some applications, the steerable shaft 112 may be omitted, and the dispensing head 96 may be positioned in a preset orientation or configured to passively orient itself to a position. In some applications, other forms of steerable shafts 112 may be utilized, such as the shaft that forms the inner shaft of the anchor distribution device 88 and other forms of steering mechanisms for the distribution head 96.

[0079] The steerable shaft 112 can be manipulated to deflect the dispensing head 96 via a steering mechanism controlled on the housing, such as, for example, a handle 130 shown in FIG.

[0080] An actuation mechanism can be utilized to cause each of the dispenser arms 98 to extend radially outward from a central portion 95 of the anchor dispensing apparatus 88 to a distal end of the respective dispenser arm 98. The actuation mechanism can be configured to pivot the dispenser arms 98 radially outward from an undeployed (or unextended) configuration to a deployed (or extended) configuration.

[0081] The actuation mechanism may include a shaft in the form of a central support 106, a shaft in the form of a sliding body 108, and a number of support arms 116 (as shown in FIG. 11). FIG. 11, for example, shows a rear perspective view of the anchor distribution device 88 without the anchors 10 and spacers 34 being displayed, nor the push body 110 and steerable shaft 112 being displayed. The central support 106 is shown as including a shaft, and the sliding body 108 includes a sheath extending over the shaft.

[0082] The dispenser arms 98 are shown not extending completely about the central axis 97, allowing for space to be provided where the dispenser arms 98 are not positioned. Such positioning may accommodate the configuration of the anchors to be dispensed at the treatment site. In some applications, the dispenser arms 98 may extend completely about the central axis 97.

[0083] 11 , each of the support arms 116 may have a distal portion 118 pivotally coupled to a respective one of the dispenser arms 98 and including a distal end including a proximal portion 120 pivotally coupled to the central support 106. The distal portion 118 of each of the support arms 116 may be coupled to a distal end of each of the plurality of dispenser arms 98. A pivot 122 may couple the distal portion 118 to the distal end of each of the dispenser arms 98, and a pivot 124 may couple the proximal portion 120 to the central support 106, e.g., to the distal end of the central support 106. The support arms 116 may be configured to pivot radially outward from an undeployed (or unextended) configuration to a deployed (or extended) configuration.

[0084] Each support arm 116 may include a compressible body 117 that may be positioned along the length of the support arm 116. Each support arm 116 may be configured to be compressed in a direction toward a proximal portion 120 of each of the plurality of support arms 116. For example, the compressible body 117 may comprise a spring or other form of compressible body that may compress the support arm 116. The compressible body 117 may further be resilient and biased against being compressed, thus exerting a force on the respective dispenser arm 98 in a distal direction. The support arm 116 may provide a spring bias radially outward against each of the plurality of dispenser arms 98.

[0085] 11 illustrates an undeployed (or unexpanded or linearized) configuration of the anchor distribution apparatus 88. The dispenser arms 98 may extend axially relative to one another in the undeployed configuration. Additionally, the support arms 116 may extend axially relative to one another and to the dispenser arms 98 in the undeployed configuration. As shown in FIG. 11, each dispenser arm 98 may overlay and be positioned outboard of the support arms 116 when the anchor distribution apparatus 88 is in the undeployed (or unexpanded or linearized) configuration.

[0086] Figure 12 shows a distal perspective view of the distal end of the dispenser arm 98 and the support arm 116. Figure 13 shows a proximal perspective view of the proximal end of the dispenser arm 98 and the support arm 116.

[0087] The actuation mechanism can be operated by a central support 106 that is slid distally relative to the slide body 108. The pivotal connection of the dispenser arms 98 and the support arms 116 allows the support arms 116 to pivot radially outward from the central portion 95 of the anchor dispensing apparatus 88, and therefore the dispenser arms 98 to pivot and extend radially outward from the central portion 95. FIG. 14, for example, shows the central support 106 that is slid distally relative to the slide body 108. The support arms 116 and the dispenser arms 98 extend radially outward from the central portion 95. The circumferential distance between the distal portions 102 of the dispenser arms 98 increases as the dispenser arms 98 spread outward from one another.

[0088] The actuation mechanism may be controlled at a proximal portion of the central support 106 and the sliding body 108. For example, the proximal portion may be controlled to cause a desired movement at a distal portion of the central support 106 and the sliding body 108. For example, a user may grasp and move the proximal portion to cause relative movement at the distal portion.

[0089] The actuation mechanism can continue to operate to extend the dispenser arms 98 outwardly from the central portion 95 of the anchor dispensing apparatus 88 to a desired radius. FIG. 15, for example, shows the central support 106 continuing to slide distally relative to the slide body 108, extending the dispenser arms 98 further radially outward. The diameter of the anchor dispensing apparatus 88 with the dispenser arms 98 in a deployed configuration is larger than the diameter of the anchor dispensing apparatus 88 with the dispenser arms 98 in a non-deployed configuration (as shown in FIG. 11 ).

[0090] The distal ends of the dispenser arms 98 may be circumferentially spaced apart from one another when the dispenser arms 98 extend radially outward from the central portion 95 in the deployed configuration, and may be equally spaced apart from one another. In some applications, other amounts of spacing between the distal ends of the dispenser arms 98 may be utilized, which may be based on the configuration of the anchor 10 to be provided to the treatment site.

[0091] With dispenser arms 98 extending radially outward from central portion 95 to a desired amount, anchors 10 may be dispensed from dispenser arms 98. Dispenser arms 98 may then be retracted radially inward in a reverse motion for removal from the treatment site.

[0092] FIG. 16, for example, shows a cross-sectional view of the channel 104 of the dispenser arm 98 along the centerline of the channel 104 with the anchor 10 and spacer body 34 positioned therein.

[0093] The push body 110 can slide distally within the channel 104 and press against the spacer body 34 and anchor 10 to dispense the anchor 10 from the dispenser arm 98. In the implementation shown in FIG. 16 , the spacer body 34 can be positioned in-line with the anchor 10, but in some applications the spacer body 34 can be positioned offset from the anchor 10 and the push body 110 can press directly against the anchor 10 to dispense the anchor 10 from the dispenser arm 98.

[0094] 17 shows a push body 110 that pushes the anchor 10 from the dispenser arm 98. When the anchor 10 is dispensed from the dispenser arm 98, it can move to an expanded state.

[0095] 18, for example, shows a perspective view of a dispenser arm 98 extending radially outward from a central portion 95, with an anchor 10 coupled thereto. The contraction member 46 is shown routed through the spacer body 34 from one end of the spacer body to another end of the adjacent spacer body 34. The contraction member 46 may be routed in a zigzag fashion such that the contraction member 46 is routed to the location of the anchor 10 where it is dispensed. In other applications, other configurations or routing of the contraction member may be utilized.

[0096] Figure 19 shows anchors dispensed from respective dispenser arms 98. Each anchor 10 can expand to the expanded configuration shown in Figure 1 upon extending from the dispenser arm 98. The distal end of each dispenser arm 98 may be in contact with or near the surface of tissue or other material for the anchor 10 to penetrate.

[0097] FIG. 20 shows a schematic diagram of the function of the compressible body 117 of the support arm 116. When the dispenser arm 98 is expanded, the dispenser arm 98 may contact a surface, such as a surface of the patient's heart, including the atrial wall or other surface. The compressible body 117 of the dispenser arm 98 that is in contact with the surface (shown on the right side of FIG. 20) may compress, thus allowing another dispenser arm 98 that is not in contact with the surface (shown on the left side of FIG. 20) to continue to expand radially outward. Thus, contact of the dispenser arm 98 against the surface may not prevent further expansion of the other dispenser arm 98.

[0098] The configuration of the anchor dispensing apparatus disclosed herein can vary in some applications, as desired. For example, in some applications, a connecting body, such as a skirt, can extend between the dispenser arms 98. Additionally, the dispenser arms can include grooves or rails in some applications. Other configurations for retaining the anchors can be utilized, as desired. In some applications, other configurations of actuation and dispensing mechanisms can be utilized, as desired. Other modifications can be provided, as desired.

[0099] The anchor distribution device can be utilized according to the application only. Thus, the disclosed anchor 10 and other components of the fastening system can be utilized separately from the anchor distribution device. The distribution head of the anchor distribution device can further be utilized separate from the shaft and other components of the anchor distribution device.

[0100] 21-25 illustrate methods in which the anchor distribution device 88 and anchor 10 may be utilized. The methods are exemplary and features may be added, removed, or substituted throughout the implementation as desired. Although the methods are shown and discussed with respect to accessing and treating the mitral valve of the heart, the systems, devices, and methods disclosed herein may also be utilized to treat other native heart valves, such as the tricuspid valve of the heart, or, mutatis mutandis, other features of the patient's anatomy. The methods may include beating heart repair of valves, including the mitral or tricuspid valves, among other valves. The disclosed methods may be transcatheter and percutaneous, although more invasive methods such as sternotomy or other methods of accessing the treatment site may be utilized in some applications, as desired. The methods may include annuloplasty methods for treating regurgitation according to the applications herein. The shape of the valve annulus may be reshaped or remodeled according to the applications herein. The methods and processes described above can be performed in live animals or in simulations, such as cadavers, cadaver hearts, simulators (eg, simulated body parts, cardiac tissue), and the like.

[0101] 21 , an anchor distribution device 88 can be passed into a patient's body 126 via percutaneous access. An elongate shaft 90 of the device 88 can be passed through a body vasculature, such as, for example, a femoral artery 128. A distribution head 96 can be covered by a sheath during initial access into the patient's body, or can be exposed during access. A user can manipulate a housing, such as a handle 130, at the proximal end of the elongate shaft 90 to move the elongate shaft 90 to the desired implantation site.

[0102] The passage of elongate shaft 90 into the patient's heart, or other implantation site, can be visualized by medical imaging equipment, including fluoroscopy and / or echocardiography, if desired.

[0103] The elongate shaft 90 can be passed transvascularly and transcatheter into the patient's heart. In some applications, the elongate shaft 90 travels transfemorally and through the inferior vena cava into the right atrium 132 of the patient's heart. Other approaches are possible, such as through the superior vena cava. In some applications where the tricuspid valve is being treated, the elongate shaft 90 can be deflected to position the dispensing head 96 in the right atrium 132 near the tricuspid valve. In some applications where the mitral valve is being treated, a transseptal puncture can be made between the right atrium 132 and the left atrium 134 to position the dispensing head 96 in the left atrium 134 near the mitral valve. Other access methods can be utilized, including transjugular access or transapical access, among others.

[0104] The anchor distribution device 88 can be positioned adjacent to the patient's native heart valve. The steerable shaft 112 can be manipulated to bias the distribution head 96 into a desired orientation relative to the mitral valve.

[0105] 22, for example, shows a top schematic view of the dispensing head 96 positioned relative to the mitral valve 136. The dispensing head 96 may be positioned to extend axially with the mitral valve 136 and may be centered over the mitral valve 136 or at another desired location. Similarly, the dispensing head 96 may be positioned over the tricuspid valve, or another valve to be treated as desired. The dispensing head 96 may be positioned on the atrial side of the valve leaflet, or may be advanced distally to be positioned within the valve annulus as desired.

[0106] Native valves may suffer from various diseases and it may be desirable to repair the native valve. For example, the annulus of the native valve may be dilated, causing valve regurgitation or other diseases. The systems, methods, and devices disclosed herein may be utilized to repair the native valve and may be utilized to shape or shrink the annulus to a desired amount. Treatment of the mitral valve may be similar to the treatments described herein. In applications where the tricuspid valve is treated, similar operations or methods to the treatment of the mitral valve may be used to treat the disease of the tricuspid valve, including reshaping or shrinking the annulus of the tricuspid valve.

[0107] The dispensing heads 96 can be moved by a dispenser arm 98 to a position adjacent the autologous valve in an undeployed configuration, for example, and can extend axially relative to one another, as shown in FIG.

[0108] When the dispensing head 96 is positioned against the autogenous valve, the actuation mechanism can be operated to expand the dispenser arms 98 radially outward. The dispenser arms 98 can be pivoted from an undeployed configuration (e.g., as shown in FIG. 10) to a radially outwardly deployed configuration (e.g., as shown in FIG. 18). FIG. 23, for example, shows a top schematic view of the dispenser arms 98 expanded radially outward. The distal ends of the dispenser arms 98 can be circumferentially spaced apart from each other by a desired amount, e.g., equal or different amounts as desired. The distal ends can be equally circumferentially spaced apart from each other as the dispenser arms extend radially outward from the central portion 95. The angle between the distal ends of the dispenser arms 98 can be equal or different amounts. Additionally, the radial distance of the distal ends of the dispenser arms 98 from the central portion 95 of the anchor dispensing device 88 can be the same or can vary. For example, as depicted in FIG. 20, if one of the dispenser arms 98 contacts the atrial wall, radial expansion of that arm 98 will stop while the other arm can continue to expand.

[0109] In particular, the dispenser arms 98 may be positioned circumferentially around only a portion of the central portion 95 of the anchor dispensing apparatus 88 at a desired location for dispensing the anchors 10. However, in some applications, the dispenser arms 98 may be positioned circumferentially around the entire central portion 95 of the anchor dispensing apparatus 88, or may be positioned according to a desired placement of the anchors.

[0110] A user may use medical imaging, such as fluoroscopy and / or echocardiography, to view the position of the dispenser arm 98 and to verify the position of the dispenser arm 98 , including the distal end of the dispenser arm 98 .

[0111] With the dispenser arms 98 in a desired position, the anchors 10 may be dispensed from the dispenser arms 98 into tissue surrounding the patient's native heart valve. A dispensing mechanism including one or more push bodies 110 may be utilized to dispense the anchors 10, for example, as shown in FIG. 17. The push bodies 110 may push the anchors 10 distally from the multiple dispenser arms 98.

[0112] In some applications, anchors 10 may be dispensed simultaneously from all of the dispenser arms 98 into tissue surrounding the patient's native heart valve, or in some applications, may be dispensed sequentially. In some applications, a combination of simultaneous and sequential dispensing may be utilized. A user can control the movement of the push body 110 to dispense anchors 10 simultaneously or sequentially, as desired. Applications in which anchors 10 are dispensed simultaneously can reduce the number of steps in a therapeutic procedure and reduce variability associated with dispensing anchors 10 sequentially. A user can selectively control the push body by controlling the movement of a proximal portion of the push body, outside the patient's body, or otherwise.

[0113] The anchor 10 can be deployed within the patient's tissue into the deployed configuration shown in Figure 1. The anchor 10 can self-expand into the deployed configuration shown in Figure 1 when pushed distally from a plurality of dispenser arms 98.

[0114] The anchors may be spaced apart from one another around the patient's native heart valve. The anchors may be positioned within a curve around the patient's native heart valve. The anchors may be positioned in a desired manner to reshape the valve annulus as desired.

[0115] Once the anchors 10 are dispensed and moved to the expanded state as shown in Figure 5, the spacer body 34 can rotate to extend between adjacent anchors 10. Figure 24, for example, shows an anchor 10 implanted around the mitral valve annulus with the spacer body 34 extending between the anchors 10. The contraction member 46 may extend through the spacer body 34, and a proximal portion 58 of the contraction member 46 may be accessible for tensioning and / or contracting the implant.

[0116] One or more contraction members 46 coupled to the plurality of anchors 10 can be tensioned to tighten the plurality of anchors 10. The contraction member 46 can extend from the distal anchor to one or more intermediate anchors and to the proximal anchor 60. The contraction member 46 can be tensioned at the proximal anchor 60.

[0117] In some applications, the lock 64 can be advanced distally along the contraction member 46 and can be advanced through the use of a tensioning mechanism as discussed in relation to Figures 7-9. The tensioning mechanism can advance the lock 64 distally into the proximal anchor 60 and tighten, tension, and / or contract the contraction member 46 in the manner discussed in relation to Figures 7-9. In some applications, other forms of tension may be utilized, for example, the implant can include a spool that can be rotated in a first direction to tighten the contraction member and rotated in a second direction to release the contraction member.

[0118] In some applications, the anchor 10 can be tightened / tensioned / retracted while the user monitors the blood flow and / or pressure from the native valve and monitors the tension of the retraction member 46 .

[0119] The distance between the anchors 10 can be decreased and, accordingly, the native annulus can be contracted or drawn closer together by movement of the anchors 10. Figure 25, for example, illustrates movement of the anchors 10 radially inward toward the mitral valve 136, thus decreasing the diameter of the mitral valve annulus 138.

[0120] A lock 64 may be utilized to lock one or more of the contraction members 46 in a tensioned configuration. The lock 64 may maintain the contraction members 46 in a tensioned state, and the cutting mechanism may cut a proximal portion of the contraction members 46 as discussed with respect to FIG. 9. The anchor 10 may remain in place about the native valve. The anchor dispensing device 88 and tensioning and cutting mechanism may be removed from the patient's body.

[0121] One or more contraction members 46 can apply tension to tighten the anchor 10 and reduce the size of the native heart valve annulus. Such tension can be utilized to treat heart valve disorders, including heart valve regurgitation, among other disorders.

[0122] The methods, systems, and devices disclosed herein can be modified as desired. For example, the location of the anchor 10 can be changed as desired. For example, one or more anchors 10 can be positioned on the leaflets of the mitral valve, or on the atrium or another location within the patient's heart or body, as desired. In applications where tricuspid valve repair is provided, the anchor 10 can surround the tricuspid valve. Other implantation locations can be utilized as desired. PCT Patent Application No. PCT / IB2020 / 060044, which is incorporated herein by reference in its entirety and for all purposes, describes additional systems, devices, methods, processes, features, components, designs, etc., that can be used and / or substituted in the present application, such as anchors, retraction members, spacers, retraction mechanisms, locks, cutting mechanisms, tools, and / or other features that can be used.

[0123] Use of the anchor distribution device 88 can provide various benefits, including simultaneous distribution of multiple anchors spaced circumferentially from one another and a reduced number of steps associated with dispensing multiple anchors. Additionally, the anchor distribution device 88 may not need to separately advance to each distribution point of the anchors 10, thereby reducing the amount of movement required of the distribution head and reducing the complexity of the procedure.

[0124] Additionally, the double curved hook shape of the anchor arms can enhance fixation of the anchor 10 to the patient's tissue, thereby reducing the number of anchors 10 used in a procedure compared to other forms of valve repair.

[0125] In some applications, the configuration of the system components can be varied as desired. For example, the configuration of the anchors 10 can be varied to include a single shaft hook, or a spiral or other configuration. Additionally, the configuration of the spacer can also be varied as desired. For example, the spacer may not be connected to the anchors 10 in some applications, but may be free to slide on the contraction member between the anchors 10. Additionally, in some applications, the number of anchors 10 and dispenser arms can be varied as desired.

[0126] FIG. 26 illustrates, for example, an application of an anchor 140 that may be utilized in accordance with the applications herein. The anchor 140 may include a distal portion 142 that includes a helical shape having a piercing tip 144 at a distal end of the anchor 140. The anchor 140 may include a rotatable body 146 at a proximal portion of the anchor 140. The anchor 140 may further include a channel 148 configured to receive a contraction member 46 in a manner similar to the channel 44 illustrated in FIG. 4. The length of the distal portion may be 8-12 millimeters, and in some applications may be about 9 millimeters, or a larger or smaller amount. The diameter of the distal portion may be 2-3 millimeters, and in some applications may be about 2.5 millimeters, or a larger or smaller amount. Other dimensions may be utilized as desired.

[0127] The spacer body 150 between adjacent anchors 140 can slide freely on the contraction member 46 between the adjacent anchors 140 and can contact the proximal portions of the anchors 140 or adjacent spacer bodies 150 to space the adjacent anchors 140.

[0128] The rotatable body 146 can be configured to rotate without rotation of the channel 148 and therefore can be coupled to the channel 148, such as by a pivot 152. In this manner, the rotatable body 146 can rotate to rotate the distal portion 142 without rotation of the channel 148. A portion of a dispensing mechanism can engage a coupling portion 154 of the rotatable body 146 to rotate the distal portion 142 without rotating the channel 148. For example, a dispensing mechanism including an anchor driver can engage the coupling portion 154 to rotate the helical shaped distal portion 142 without rotating the channel 148.

[0129] The anchors 140 may be deployed by a dispenser arm 98 as disclosed herein and may slide along a channel of the dispenser arm 98. A dispensing mechanism may push and engage the linking portion 154 and rotate the rotatable body 146 to secure the distal portion 142 into engagement with tissue. The anchors 140 may be spaced from adjacent anchors via the spacer body 150 and may be operated in a similar manner as other anchors disclosed herein. Other variations of the anchors may be utilized according to the applications herein.

[0130] A "user" as described herein can include a user of the systems and devices disclosed herein, including, but not limited to, a surgeon or another individual, such as a medical professional, who may operate the systems and devices disclosed herein.

[0131] The apparatus and other apparatus disclosed herein can be practiced separately, as desired. Additionally, the methods herein are not limited to the methods specifically described, but can include methods utilizing the systems, apparatus, and devices disclosed herein.

[0132] In summary, although aspects of the present specification are highlighted by reference to specific implementations, it will be understood that those skilled in the art will readily recognize that these disclosed implementations are merely illustrative of the principles of the subject matter disclosed herein. Thus, it should be understood that the disclosed subject matter is in no way limited to the specific methodology, protocols, and / or reagents, etc. described herein. Thus, various modifications or variations of the subject matter disclosed herein, or alternative configurations, can be made in accordance with the teachings herein without departing from the spirit of the present specification. Finally, the terms used herein are for the purpose of describing specific implementations only, and are not intended to limit the scope of the systems, devices, and methods as disclosed herein, which are defined solely by the claims. Thus, the systems, devices, and methods are not limited to the precise manner as shown and described.

[0133] Particular implementations of the systems, devices, and methods are described herein, including the best mode known to the inventors for carrying them out. Naturally, variations of these described implementations will become apparent to those of ordinary skill in the art upon reading the above description. The inventors expect those of ordinary skill in the art to adopt such variations as appropriate, and the inventors contemplate the systems, devices, and methods being practiced otherwise than as specifically described herein. Accordingly, the systems, devices, and methods include all modifications and equivalents of the subject matter recited in the claims appended hereto as permitted by applicable law. Moreover, any combination of the above-described implementations in all possible variations thereof is encompassed by the systems, devices, and methods unless otherwise indicated herein or clearly contradicted by context.

[0134] Groupings of alternative implementations, elements, or steps of systems, apparatus, and methods are not to be construed as limitations. Each group member may be referred to and claimed individually or in any combination with other group members disclosed herein. It is anticipated that one or more members of a group may be included in, or removed from, a group for reasons of convenience and / or patentability. When such inclusion or removal occurs, the specification will be deemed to contain the modified group and thus satisfy the description of all Markush groups used in the appended claims.

[0135] Unless otherwise indicated, all numbers expressing features, items, quantities, parameters, properties, terms, etc. used in the specification and claims are to be understood in all instances as being modified by the term "about." As used herein, the term "about" means that the feature, item, quantity, parameter, property, or term so modified encompasses approximations that may vary, but still be able to perform the desired operation or process discussed herein.

[0136] The terms "a," "an," "the," and similar references used in the context of describing systems, devices, and methods (particularly in the context of the claims below) shall be construed as covering both the singular and the plural, unless otherwise indicated herein or clearly contradicted by context. All methods described herein may be performed in any suitable order, unless otherwise indicated herein or clearly contradicted by context. Furthermore, the techniques, methods, steps, etc. described or suggested herein or in these incorporated references may be performed in living animals, or in non-living simulations, such as cadavers, cadaver hearts, simulators (e.g., simulated body parts, tissues, etc.), etc. The use of any and all examples or exemplary language (e.g., "such as") provided herein is intended merely to better illuminate the systems, devices, and methods, and does not pose a limitation on the scope of the systems, devices, and methods otherwise claimed. No language in the specification should be construed as indicating any non-claimed element essential to the practice of the systems, devices, and methods.

[0137] All patents, patent publications, and other publications referenced and identified in this specification are individually and expressly incorporated herein by reference in their entirety for the purpose of describing and disclosing the compositions and methodologies described in such publications that may be used in connection with, for example, the systems, apparatus, and methods. These publications are provided solely for their disclosure prior to the filing date of this application. Nothing in this regard should be construed as an admission that the inventors are not entitled to antedate such disclosure by reason of prior invention or for any other reason. All statements as to the date or representation as to the contents of these documents are based on the information available to the applicants and do not constitute an admission as to the accuracy of the dates or contents of these documents.

Claims

1. 1. A fastening system comprising: a plurality of anchors, each configured to be secured to tissue of a patient's body; one or more contraction members connecting the plurality of anchors to one another and configured to tighten the plurality of anchors; a plurality of spacer bodies configured to engage the one or more contraction members and space the plurality of anchors from one another when the plurality of anchors are secured to the tissue; an anchor dispensing device having a central portion and including a plurality of dispenser arms circumferentially spaced from one another, each configured to extend radially outward from the central portion to a distal end of a respective dispenser arm, each dispenser arm configured to dispense at least one of the plurality of anchors into the tissue of the patient's body.

2. The anchoring system of claim 1 , wherein the central portion includes a central support, and each of the plurality of dispenser arms includes a proximal portion coupled to the central support.

3. The anchoring system of claim 1 , wherein each of the plurality of dispenser arms is configured to pivot radially outward from an undeployed configuration to a deployed configuration.

4. 4. The anchoring system of claim 3, further comprising an actuation mechanism configured to pivot each of the plurality of dispenser arms radially outward from the undeployed configuration to the deployed configuration.

5. The actuation mechanism comprises: a plurality of support arms, each of which is coupled to one of the plurality of dispenser arms; a first shaft coupled to a proximal portion of the plurality of dispenser arms; a second shaft coupled to a proximal portion of the plurality of support arms and configured to move relative to the first shaft to pivot each of the plurality of support arms radially outward.

6. The fixation system of claim 1 , wherein the distal end of each of the dispenser arms is configured to dispense the at least one of the plurality of anchors.

7. The fixation system of claim 1 , wherein the distal end of each of the dispenser arms includes an opening through which the at least one plurality of anchors is dispensed.

8. The fixation system of claim 1, wherein each of the plurality of anchors is configured to move from an undeployed configuration to a deployed configuration and has a linearized shape in the undeployed configuration and an expanded shape in the deployed configuration.

9. The fixation system of claim 8 , wherein each of the plurality of anchors is configured to self-expand from the undeployed configuration to the deployed configuration.

10. The fixation system of claim 1 , wherein each of the plurality of anchors has at least two anchor arms connected together at a central portion of the anchor and each extending to a distal end of the respective anchor arm.

11. The fixation system of claim 10 , wherein the at least two anchor arms are configured to form curved hooks extending outwardly from one another.

12. The fixation system of claim 1 , wherein the plurality of spacer bodies are configured to extend over the one or more contraction members.

13. The fixation system of claim 1 , wherein each of the plurality of spacer bodies is configured to pivotally couple to one of the plurality of anchors.

14. 2. The fixation system of claim 1, wherein the plurality of spacer bodies are each configured to extend axially relative to one of the plurality of anchors when a respective one of the plurality of anchors is in an undeployed configuration.

15. The fixation system of claim 1 , wherein each of the plurality of dispenser arms includes a channel configured to hold at least one of the plurality of anchors and at least one of the plurality of spacer bodies.

16. The fastening system of claim 1 , further comprising a tensioning mechanism for tensioning the one or more contraction members.

17. The fastening system of claim 1 , further comprising a lock for locking the one or more contraction members in a tensioned configuration.

18. The fastening system of claim 17 , further comprising a cutting mechanism for severing the one or more contraction members in the tensioned configuration.

19. The fastening system of claim 1, further comprising a dispensing mechanism for dispensing each of the plurality of anchors from the plurality of dispenser arms, the dispensing mechanism including one or more push bodies configured to push the plurality of anchors distally from the plurality of dispenser arms.

20. The fixation system of claim 1, wherein the anchor distribution device is configured to distribute the multiple anchors to tissue surrounding the mitral valve or tricuspid valve.

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