HK1166943A - Reconfiguring heart features - Google Patents

Description

Reconstructing cardiac features

This application is a continuation-in-part application of U.S. patent application 12/563,293 filed on 21/9/2009, and claiming priority of U.S. patent application 12/563,293, U.S. patent application 12/563,293 is a continuation-in-part application of U.S. patent application 12/407,656 filed on 19/3/2009, and U.S. patent application 12/407,656 is a continuation-in-part application of U.S. patent application 11/620,955 filed on 8/1/2007, all of which are incorporated herein by reference in their entirety.

Technical Field

The description relates to reconstructing cardiac features.

Background

The annulus of a heart valve (the annulus of fibers attached to the heart wall, for example, holds the valve in an open shape and supports the valve leaflets. in a healthy heart, the annulus is typically round and has a diameter that enables the leaflets to close tightly against the valve, thereby ensuring that there is no backflow of blood during systole. because, for example, the annulus of the tricuspid valve is more stably supported by heart tissue on one side of the annulus than on the other, and because of other reasons, the size and shape of the annulus can deform over time.

Disclosure of Invention

In general, in one aspect, a cardiac tissue support has gripping elements, each gripping element having: a free end sufficiently sharp to penetrate heart tissue when pushed against the tissue; and a feature to prevent withdrawal of the gripping element from the tissue after the sharp free end has penetrated the tissue.

Embodiments may include one or more of the following features. The free end of the gripping element may protrude away from the surface of the support. The feature to resist withdrawal of the gripping element from the tissue may comprise a finger projecting laterally from the gripping element. The cardiac tissue support may include an annular surface supporting a gripping element. The support may be expandable and collapsible. The support may have a configurable natural size. The cable may be configured with natural dimensions. The support member may comprise at least one of stainless steel, gold, nitinol, or a biocompatible elastomer. The support member may comprise a flower receptacle. The support may comprise a helically wound portion. Some portions of the support may not support the gripping element. The gripping elements may be organized in a pattern. The pattern may comprise rows. The pattern may include groups in which the gripping elements are more densely arranged and groups in which the gripping elements are less densely arranged. The pattern may comprise an arc. The pattern may comprise clusters. The pattern may comprise a random arrangement. At least some of the gripping elements may comprise an alloy of platinum, gold, palladium, rhenium, tantalum, tungsten, molybdenum, nickel, cobalt, stainless steel, nitinol, and any combination thereof. The gripping elements may be of the same size. Some gripping elements may be of different sizes. At least some of the gripping elements may have more than one feature that recedes against. At least some of the gripping elements may project perpendicularly from the surface. At least some of the gripping elements may be curved. The cardiac tissue support may also include a sleeve through which tissue may grow. The sleeve may comprise polyethylene terephthalate. There may be between about 15 and one million gripping elements on the support. There may be between about 100 and about 100,000 gripping elements. The gripping element may comprise a barbed hook. The gripping element may comprise an arrow. The gripping element may comprise a hook.

The support may comprise annular elements, pairs of which are connected along the edges of the elements to form a ring. Each of the annular elements may carry at least one grip. Each annular element may also carry a pointed element aligned in the opposite direction to the grip. Each ring element may comprise a hexagon.

In general, in one aspect, the shape of a heart valve annulus is modified in a catheter laboratory by orienting the tip of a catheter holding a cardiac tissue support having gripping elements on the valve annulus to apply a radial force from the catheter against the annulus by opening a structure at the tip of the catheter and forcing the support onto the valve annulus when the structure is opened.

In general, in one aspect, the shape of a heart valve annulus is modified during a surgical procedure by pushing a heart tissue support having gripping elements onto the valve annulus.

In general, in one aspect, a method includes attaching supports to different sized heart valve annuluses of different patients, the supports being deployable in preparation for attachment and allowed to contract to a common relaxed, non-deployed natural size when they are in place on the annulus, and reducing the size of at least some of the in-place supports to less than the common relaxed, non-deployed natural size to accommodate the different sized heart valve annuluses of the different patients.

In general, in one aspect, a cardiac tissue support comprises a plurality of small grippers, each having a tissue penetrating feature and a retaining feature, the configuration of the grippers relative to the configuration of a given region of cardiac tissue to which the support is attached by force such that the penetrating features of a failed group of grippers will not penetrate the tissue, the penetrating features of a second group of grippers will successfully penetrate the tissue, the retaining features of a subset of the second group of grippers will not retain the grippers in the tissue, and the retaining features of the remaining grippers of the second group will successfully retain the grippers in the tissue and the support in the intended configuration on the tissue.

In general, in one aspect, a method includes pushing a support onto a region of cardiac tissue such that only a portion of a number of small graspers on the support embed themselves in and remain in the tissue, the portion being sufficient to securely attach the support to the cardiac tissue.

In general, in one aspect, an annular heart valve support is expandable and collapsible and carries a gripping element configured to penetrate heart tissue and retain the element in the tissue after penetration.

In general, in one aspect, a tool for attaching a support to a heart valve annulus includes a mechanism for holding the support in a deployed configuration prior to attachment, deploying the heart valve annulus prior to attachment such that the support is attached to the deployed valve annulus in its deployed configuration, and releasing the deployed support to a retracted configuration after attachment.

Implementations may include one or more of the following features. The tool may be attached to the catheter tip. The tool may also include an inflatable balloon. The bladder may function as a positioning tool. The mechanism may also remove the tool from the heart after attachment.

In general, in one aspect, a tool for attaching a support to a heart valve annulus includes a structure that deploys the annulus of the heart to a predetermined shape under control of an operator.

Embodiments may include one or more of the following features. The structure of the tool may have a conical outer surface, at least a portion of which conforms to a predetermined shape. The structure of the tool may have an outer surface that can be deployed to a predetermined shape.

In general, in one aspect, a buttress for living tissue includes a gripping element for attaching to the living tissue and securely holding the buttress in place. The ring structure is coupled to the gripping element. The loop structure adjusts the support between a first configuration for mounting the support and a second configuration in which the support is securely held in place after mounting. The ring structure is self-supporting in the first and second configurations.

Embodiments may include one or more of the following features. Living tissue includes, for example, heart tissue, the annulus of a heart valve. The grasping element is configured to penetrate tissue during installation and to grasp tissue after installation. The ring-like structure is circular. The ring structure has elements that move annularly relative to each other to adjust the support between the first configuration and the second configuration. The loop structure is larger when the support is in the first configuration than when the support is in the second configuration. The ring structure changes its shape to adjust the support. The ring-like structure changes its shape during installation without changing the position of the gripping element relative to the living tissue.

The ring structure includes a first element to which the gripping element is attached and a second element that is slidable relative to the first element when the ring structure adjusts the support between the first configuration and the second configuration. The first member comprises a resilient annular tube to which the gripping member is attached and the second member comprises a rigid adjustable member that is slidable within the tube. The second element comprises a self-supporting coil. The self-supporting coil includes a rigid strip material having two free ends that are movable relative to each other to adjust the support between a first configuration and a second configuration. The ring structure includes features defining a spacing of gripping elements coupled to the ring structure.

The gripping element is adjustable between a first configuration for mounting the support and a second configuration in which the support is held securely in place after mounting. The loop structure and the gripping element are configured such that, when the support is adjusted between the first configuration and the second configuration, the gripping element is automatically adjusted between the first configuration and the second configuration. The loop structure includes a cross-sectional area that increases as the support is adjusted between the first configuration and the second configuration, and the grip element is coupled to the loop structure such that the grip element is adjusted between the first configuration and the second configuration as the cross-sectional area of the loop structure decreases.

Each gripping element includes a ring and a piercing element attached to the ring, the orientation of the piercing element changing as the ring changes between the first configuration and the second configuration. The adjustment of the support between the first configuration and the second configuration is reversible without the grasping element damaging the tissue.

The ring structure includes a lock that prevents a change in the configuration of the support. The locking member includes a pair of mating elements. One of the mating elements includes a tab and the other includes a slot. One of the mating elements comprises a pin and the other comprises a hole for the pin. The ring-like structure has a central axis and comprises two parts which are movable relative to each other around the central axis to a position in which the mating elements are to be mated.

In general, in one aspect, a grasping element includes a tip that penetrates living tissue and an elastic ring that supports the tip. The elastic loop has a relaxed configuration and a non-relaxed configuration. The tip has different orientations associated with the relaxed configuration and the non-relaxed configuration, respectively.

Embodiments may include one or more of the following features. The tip has at least one barb. The grip comprises more than one such tip. The leading resilient support of the tip has a configuration.

The grip comprises a cable. The rings are circular. The grip member comprises a material forming strip. Having two such tips facing each other and acting as forceps in at least one of a relaxed configuration and a non-relaxed configuration.

In general, in one aspect, a heart valve repair ring includes a circular, self-supporting, elastomeric ring having a relaxed diameter corresponding to a healthy heart valve and an enlarged diameter to accommodate an insertion tool. The grip is attached to the elastomeric ring and oriented in a direction that automatically changes between an insertion direction and an installation direction during installation.

In general, in one aspect, a method includes forcing a pointed gripping member on a support to penetrate tissue of an annulus of a heart valve and securely holding the support on the annulus to modify a shape of the annulus. At least a portion of the support is then removed from the annulus by withdrawing at least some of the cusps grips without damaging the heart valve annulus.

In general, in one aspect, a method includes mounting an expanded resilient support on a heart valve annulus to allow the support to contract to a healthy annulus diameter and locking the contracted support in its contracted diameter by mating elements of the support.

In general, in one aspect, a method includes positioning a gripping element coupled to a heart annulus support ring in annulus tissue during installation by allowing the support ring to collapse from an expanded size to a smaller size. Advantages of these and other aspects and features may be found in one or more of the following. The operator does not have to work slowly to properly attach the cardiac tissue support to the annulus nor does the placement need to be as precise. Not all of the bur hooks or catches must be attached to the circumferential band to hold the support in place. Some barbed hooks or grips may fail to grip onto tissue or be pulled away from tissue by force. Nevertheless, as long as a minimum threshold percentage of bur hooks or catches remain in place, the tissue support will also remain in place. Further, due to its ease and simplicity, the procedure can be performed in a catheterization laboratory as well as intraoperatively.

These and other aspects and features, and combinations thereof, may be expressed as apparatus, methods, systems, and in other ways.

Other features and advantages will be apparent from the description and the claims.

Drawings

Fig. 1A-1H and 13A-13D illustrate delivery of a heart valve support.

Fig. 2A-2D are perspective views of a heart valve support.

Fig. 2E is a plan view of the incurved hook.

Figure 3 is a cross-sectional side view of a heart valve support.

Fig. 4A-4C are side and detail views of a delivery tool and a heart valve support.

Fig. 5 is a side view of the delivery tool.

Fig. 6A and 6B are cross-sectional side views of a catheter delivery tool.

Fig. 7A-8I illustrate delivery of a heart valve support.

Fig. 9A, 9R, 9T and 9U are plan views of cardiac tissue supports.

Fig. 9B, 9P and 9S are perspective views of a portion of a cardiac tissue support.

Fig. 9C-9E, 9G and 9H are side views of a barbed hook.

Fig. 9F is a schematic view of a cardiac tissue support attached to annular tissue.

Fig. 9I-9M and 9O are enlarged views of the surface of the cardiac tissue support.

Fig. 9N and 9Q are views of a cardiac tissue support and delivery tool.

Fig. 10A and 10B are side views of a delivery tool and a cross-section of a sheath.

Fig. 10C and 10D are cross-sectional views of the delivery tool and sheath.

FIG. 11A is a perspective view of a delivery tool in a cardiac annulus.

Fig. 11B is a view of the operator end of the delivery tool.

Fig. 11C and 11F are enlarged views of a cardiac tissue support attached to a delivery tool.

Fig. 11D and 11E are enlarged views of a portion of a cardiac tissue support attached to annular tissue.

Fig. 12A and 12B are views of the core of a delivery tool.

Fig. 12C is a perspective view of the core of the delivery tool.

Fig. 14A-14D are perspective views of portions of a support.

Fig. 15 is a perspective view of the anchor.

FIG. 16 is a perspective view of the grip.

FIG. 17 is a side view of the grip.

Fig. 18 is a perspective view of the cover.

Fig. 19 is a sectional perspective view of the support member.

Fig. 20 is a perspective view of the support member.

Fig. 21 is an enlarged perspective view of a portion of the support.

FIGS. 22-25 are top views of the grip.

Figures 26 and 27 are top views of the gripping member.

Fig. 28, 29, 30 and 31 are a perspective view, a sectional perspective view, a perspective view and a sectional perspective view, respectively, of a support member.

FIG. 32 is a top view of the grip.

Fig. 33-35 are top, top and perspective views of a support on a hypothetical insertion tool.

Fig. 36-39 are side views of the insertion tool.

Fig. 40 is a side view of the insertion tool.

Fig. 41 is a perspective view of an insertion tool.

Fig. 42 and 43 are side views of the insertion tool.

Fig. 44 is a side view of the insertion tool.

Fig. 45 and 46 are a perspective view and an enlarged perspective view of a part of the support member.

Fig. 47 and 52 are perspective views of the support member.

Fig. 48 and 53 are perspective and side views of the anchor.

Fig. 49 is a perspective view of a coil.

FIG. 50 is a perspective view of an elastomeric ring.

FIG. 51 is a perspective view of a ring and coil assembly.

Fig. 54 and 55 are perspective and side views of the interlock.

Fig. 56 and 57 are perspective views of the interlock.

Fig. 58 and 59 are perspective views of the support member.

Fig. 60A and 60B are views of a part of the support.

Fig. 61A and 61B are top views of the support.

Detailed Description

As shown in the example of fig. 1A-1G, the deformation of the annulus 18 of the heart valve 16 can be corrected simply and quickly by:

A. the cone-head tip basket 220 of the delivery tool 200 is pushed 201 (fig. 1A) into the valve to force the deformed annulus (203, fig. 1F) to follow the desired configuration (e.g., circle 205, fig. 1G) and a size (e.g., at diameter 207) that is greater than the desired final diameter 209 of the annulus (fig. 1H). (the tool including the basket is shown in side view and the valve and annulus are shown in cross-sectional side view.)

B. The delivery tool is pushed 201 on to drive the deployed heart valve support 100 (which has the desired configuration and larger size and is temporarily held in its deployed configuration on the tool's basket) toward the annulus to simultaneously position a plurality (e.g., eight, as shown, or a greater or lesser number) of incurved hooks 120 positioned along the periphery of the support at a plurality of locations along the periphery 121 of the annulus into the valve tissue (fig. 1B).

C. After hook positioning, pull 204 from inside on the tip 230 of the head end basket (fig. 1C) and flip the tip 230 to wind the support to turn 211 the tips 122 of the hooks and embed themselves more firmly into the annulus tissue (fig. 1C).

D. After the hook is further inserted, pulling 204 fig. 1D on the interior 213 of the tip of the head end basket continues to clear the support break-off tool (fig. 1E), allowing the support to contract to its final size and shape 215 (fig. 1H) and leaving the support permanently in place to hold the circumferential band in the desired final configuration and size.

The entire program may be executed in a minute in many cases. By temporarily forcing the annulus of the valve to expand to the desired circular shape, the support can be attached quickly, easily, and somewhat automatically by forcing a plurality of gripping elements into the tissue at one time. Although hooks are used in this example, other types of gripping elements may be used. The physician avoids the time-consuming steps: a suture or clip must be attached along the perimeter of the deformed circumferential band at one time and then brought together to reform the supported circumferential band into the desired shape and size. In this way, the physician need not even be able to see the annulus clearly (or not at all). Once attached, the support automatically springs back to its final form and size when the tool is removed.

As shown in fig. 2A and 2D, in an embodiment, the support comprises a circular ring body carrying hooks 120. The body 110 may be deployed from (a) a minimum diameter long-term configuration (fig. 2A) that it follows after the body has been attached to the circumferential band, to (B) a deployed delivery configuration (fig. 2D) that it follows when the body is held on the head end basket of the tool and when it is being attached in the steps shown in fig. 1A, 1B and 1C. The long-term configuration is generally circular and has an annulus diameter for the health of a particular patient. When attached, the support maintains a healthy configuration of the annulus so that the valve will function properly.

In some examples, the body 110 has the same (e.g., circular) shape but different diameters in the delivery configuration and the long-term configuration. The body is constructed of a material or in a manner that biases the body to collapse to the long-term configuration. For example, all or a portion of the body 110 may be formed as a coil spring 110a, such as a continuous coil spring connected at opposite ends to form a circular body or one or more interconnected coil spring portions (fig. 2B). In some examples, the support body 110b can be a ribbon-shaped memory material, such as nitinol or a biocompatible elastomer (or other material), that will return to a long-term configuration after deployment to a delivery configuration (fig. 2C).

The hooks 120 can be 3, or as many as 10 or 20, or more in number, and can be positioned at equal intervals along the body, or at unequal intervals as desired, to easily and quickly deliver and permanently locate the body in its position and effectively correct the deformation of the valve annulus. The hooks are configured along a circular outer perimeter and fit together so that they can be inserted into tissue simultaneously along the perimeter of the circumferential band and then securely embedded when the tool is pulled away and the basket is inverted.

In some examples, a portion or portions of the support body may not have hooks attached, for example if portions of the valve annulus share boundaries with sensitive or delicate tissue, such as the Atrioventricular (AV) node of the heart. The tissue should not be punctured by the hooks. The support body configured to avoid interference with the AV node may have no hooks attached or otherwise be covered or protected to prevent the hooks from sticking into the AV node. The buttress body should be positioned such that when the buttress body is disposed in place, that particular portion of the buttress body is adjacent to sensitive or delicate tissue. The buttress body may have more than one specific portion without hooks, such that the operator has more than one option in placing the buttress body in proximity to sensitive tissue. In some examples, the support body may have a portion that is completely removed, and may be somewhat like the shape of the letter "C" rather than the shape of a completed ring. In either of these examples, the procedure described above may have a further step prior to step a in which the operator rotates the delivery head to position the portion without hooks or to position the gap in the support body adjacent to sensitive tissue when the hooks are to be embedded in other tissue. The support body may have radiopaque markers to aid the operator in visualizing the positioning.

For this reason, as shown in fig. 2E, for example, each hook has two pointed features. One sharp feature is a sharp free end 122 that points away from the valve leaflet during delivery. Another pointed feature is a barb 128 formed at the bend between the sharp free end 122 and the opposite connecting end 124 where the hook is attached, e.g., welded or glued, to the body 110. The barbs are directed toward the valve leaflets during delivery. In this way, the barbs are arranged to penetrate tissue when the tool is pushed towards the valve, and the sharp free ends are arranged to embed the hooks into the tissue when the tool is pulled away from the valve.

Each hook 120 may be formed from a biocompatible material such as platinum, gold, palladium, rhenium, tantalum, tungsten, molybdenum, nickel, cobalt, stainless steel, nitinol and alloys, polymers, or other materials. During delivery, the barbs of the hooks are advanced together (and substantially simultaneously) into the tissue at a series of locations around the outer perimeter of the temporarily deployed annulus. In a subsequent step, the sharp free tip is turned slightly away from the leaflet for secure (e.g., permanent) attachment.

To rotate the hooks during delivery, the hooks 120 are permanently attached to the support body 110, and the support body may be wound 123 (fig. 3) about the central annular axis 112 of the support body, as indicated. One way of making the support body wrap around and the hook turn accordingly is to make the body able to change its configuration by turning the entire body around an axis represented by a central circular axis 123, much like a rubber O-ring can wrap around its central circular axis. The reconfiguration of the body to allow the hook to rotate may be achieved in other ways.

In some instances, applying an axial force (arrow 113) to the inner peripheral edge of the loop (we sometimes refer to the support broadly as a loop) will tend to cause the loop to wind and cause the hooks to seat themselves in the loop as desired. With the inner periphery of the ring properly mounted on the outer periphery of the delivery tool, the axial force 113 can be applied by pulling the tool away from the leaflets of the valve, as explained previously.

To deliver the valve annulus, the valve support 100 is first deployed to its delivery configuration and temporarily mounted on the delivery head 220 of the tool 200 (fig. 4A). The support may be fully deployed in its temporary mounting on the tool and mounted along the conical head end basket sufficiently far from the tip so that when the head end basket of the tool is pushed against the circumferential band to force it to deploy to the size and shape of the deployed support, the circumferential band first reaches a circular, non-deformed shape before the support hook barbs begin to penetrate the tissue. The tapered profile of the head end basket of the delivery tool allows the tool to accommodate supports of various sizes. In some embodiments, different shapes and sizes of baskets may be used for different sizes of supports.

The heart valve support 100 is held in place on the delivery head 220 using one or more releasable connections 246. Connector 246 is positioned to transmit forces from tool 200 in each of two opposite directions 248 and 250 toward or away from the leaflets of the valve to support 100. When the support has been embedded in the annulus and the tool is pulled in direction 250 to release it from the support, the force on the connector 246 exceeds a predetermined threshold, the connector breaks, releasing the tool from the support at the end of the delivery process. The connector 246 may in some instances be a breakable suture 252 (fig. 4A), or some other breakable structure, such as a clip or adhesive or a structure that can be manipulated from a tool by unscrewing or other manipulation.

In some examples, connector 246 includes a retainer, which may, for example, assume the configuration shown as 254a or 254B (shown in fig. 4B, 4C, respectively). In the example shown in fig. 4B, retaining element 254a has a rigid finger 256 to transfer force from tool 200 to support 100 when the tool is moved in direction 248 with the support attached to the tool and pushed into the cardiac tissue. The second deformable fingers 258 help to retain the connector between the support 100 and the tool 200 when the tool is moved in the direction 250 and is deformable (dashed line) to release the valve support 100 from the tool 200 in the event that the force in the direction 250 relative to the embedded support exceeds a predetermined threshold.

In the example shown in fig. 4C, the retaining element 254b includes a finger 260 having a bend 262 to receive the support 100 and transfer force from the tool 200 to the support 100 when the tool is moved in the direction 248. The fingers have resiliently deformable tips 264, said tips 264 being biased towards the tapered body 222 and helping to retain the connector between the support 100 and the tool 200, and the tips 264 are deformable (as shown in phantom) to release the valve support 100 from the tool 200 when the tool is moved in the second axial direction 250 against the embedded support and the force exceeds a predetermined threshold.

In the example of a tool 200, shown in fig. 5, which may be used for a delivery basket 220 of a support during open heart surgery, is connected at its wide end to a set of rigid cables or other rigid projections 216 that flare out at the operator's end 214 from a long shaft 210 with a handle 212. In this way, the protrusion 216 connects the stem 210 to the basket 220 and transmits a pulling or pushing force between the stem and the basket (and correspondingly the support).

The example basket shown in fig. 5 includes a conical body 222 having a network of interconnected struts 224 defining an array of openings 226 that together form a conical semi-rigid web. In this example, the basket (which we sometimes also refer to as a delivery head) 220 has a rounded tip 228. The head 222 tapers radially outward a distance from the tip 228 toward the operator along a longitudinal axis 234 of the head 220. The wide tip 232 of the conical body 222 is firmly attached to the protrusion 216, the protrusion 216 tapering in a direction opposite to the basket tapering direction. The mesh formed by struts 224 is semi-rigid, somewhat rigid to allow the operator to force the valve support against the heart tissue to cause the barbs of the hooks of the support to pierce the tissue, and flexible enough to allow the head end basket to flip when the operator pulls on the handle to flip the basket and release the support from the basket.

In some embodiments, the shaft 210 defines a lumen 236 extending between the heart valve tip 218 of the shaft 210 and the handle 212. Cable 238 is positioned to move freely back and forth within lumen 236. The cable 238 has one end 240 extending from the handle 212 and an opposite end 242 connected to the interior of the tip 228. Cable 238 can be pulled (arrow 244) to collapse (dashed line) delivery head 220 and evert radially inward from tip 228, as previously described.

Returning to the more detailed discussion of fig. 1A-1E, the operator begins delivery of the support by pushing the tapered tip 230 of the head basket 220 into the valve 16 (e.g., the tricuspid valve) to spread the valve leaflets 14 apart. The tip 230 is small and rounded, which makes it relatively easy to insert into the valve without the need for very precise guidance. Because the head end basket is tapered, the operator, by continuing to push, can cause the annulus 18 of the tricuspid valve 16 to expand in size and conform to a desired shape, typically a circular shape. During insertion, the head end basket tends to center itself because of its symmetrical taper. The taper of basket 220 converts the insertion force in direction 248 into a radial force that causes cuff 18 to unfold and temporarily assume the desired shape (and greater than the final diameter).

As the operator continues to push on the tool, the barbed loops of the hooks contact and then enter (pierce) the heart tissue along the loops of the insertion site defined by the outer periphery of the circumferential band, with the sharp free ends of the hooks entering the tissue and positioning themselves in the tissue, much like a fish hook. With how the tool is guided in operation, the basket can be oriented during insertion so that substantially all of the hooks enter the tissue at the same time. Alternatively, the tool may be tilted during insertion so that hooks on one side of the support enter tissue first, and then the tool delivery angle may be varied to force the other hooks into tissue in sequence.

Generally, when the number of hooks is relatively small (i.e., between 6 and 20, compared to the number of stitches a physician would use in traditionally suturing a loop to a circumferential band), it may be desirable to ensure that all hooks penetrate the tissue and are properly positioned.

Once the hooks are embedded in the tissue, the operator pulls on the tip 240 near the cable 238 to collapse the basket 220 (collapse), invert, and withdraw the valve 16. Eventually, the everted portion of the basket reaches the valve support 100. By pulling further, the operator causes the body 110 of the support 100 to wrap around its central axis (as in the previous O-ring example), which causes the hooks 120 to more securely embed in the tissue of the annulus of the valve 16.

With final pull, the operator breaks the connector between the tool 200 and the valve support 100 and removes the tool 200, leaving the valve support 100 in place. With the inverted basket 220 in place by the connector 246, the retention force acting in direction 248 exerted by the embedded hooks 120 of the support member body 110 exceeds the force acting in direction 250 exerted by the exiting basket 220 on the support member body 110 (via the connector 246), causing the connector 246 to break or release, thereby releasing the support member 100.

The tool 200 is then withdrawn, allowing the valve support 100 to contract with the annulus to the long-term-operation configuration.

In an embodiment for a percutaneous delivery support, as shown in fig. 6A, the delivery head 220a can be made of, for example, a shape memory alloy, such as nitinol, which will allow the body 222a to radially collapse toward the longitudinal axis 234a prior to and during delivery of the head into the heart from a percutaneous access point (i.e., femoral vein). Delivery head 220a is biased toward the deployed, tapered configuration as shown in fig. 6A. In this way, delivery head 220a, which is in the form of a tapered semi-rigid mesh, is connected to catheter shaft 210a by protrusion 216a which flares radially outward from catheter shaft 210a and tapers in a direction opposite to the direction of taper of delivery head 220 a. (Here we refer to the delivery head as the head end basket.)

The protrusion 216a is resiliently mounted to the catheter shaft 210a and biased in the direction of the flared cone as shown, for example, by a spring-biased protrusion 216B as shown in fig. 6B. The projection 216a includes a spring 278, such as a torsion spring (as shown), mounted to the catheter shaft 210a and forming a resilient connection.

The cable 238a slides within the lumen 236a of the shaft 210a in a manner similar to that described earlier.

The tool 200a also includes a sheath 280 in which the catheter shaft 210a can slide during deployment of the support. The sheath 280, catheter shaft 210a, and cable 238a are all flexible along their length to allow the tool 200a to deflect and articulate along the blood vessel to reach the heart and allow manipulation of the delivery head once inside the heart.

To deliver the support percutaneously, as shown in fig. 7A, when the delivery head is ready for use, the sheath 280 is retracted beyond the protrusion 216a, allowing the delivery head 220a to deploy. The valve support 100 is then deployed to a delivery configuration (either manually or with a deployment tool) and mounted on the conical body 222 a. Valve support 100 is connected to delivery head 220a with a releasable connection, breakable suture and/or retention elements (as described previously).

The sheath 280 is then moved along the catheter shaft 210a toward the delivery head 220 such that the protrusions 216a and the delivery head 220a are retracted radially inward to fit within the sheath 280, as shown in fig. 7B. In the collapsed configuration, the tip 228a of the delivery head 220a bears against the tip 282 of the sheath 280. The rounded tip 228a may provide earlier delivery and maneuverability, for example, in navigating a vessel to reach the heart.

To deliver the support to the valve annulus, tip 230 of tool 200a is percutaneously fed through the vessel and into right atrium 24 (fig. 8A). Sheath 280 is then retracted, exposing valve support 100 and allowing protrusion 216a, delivery head 220a, and support 100 to deploy, as shown in fig. 8A.

In a step somewhat similar to the open-heart arrangement of the support, the catheter shaft 210a is then advanced in a direction 248a along the axis 30 of the annulus 18, e.g., under image guidance. The operator forces the distal end 230a of the self-centering delivery head 220a into the valve 16 (fig. 8B) with sensory or image guidance without actually seeing the valve 16.

Once the tip is in the valve 16, the operator pushes on the end 214a of the catheter shaft 210a to force the tool further into the valve 16. This causes the tapered body 222a of the delivery head 220a to restore the shape of the annulus 18 to a circular or other desired shape (e.g., the particular "D" shape of a healthy mitral valve). Tool 200a tends to center itself because of its shape. The mesh structure of delivery head 220a (and heads used in open heart surgery) allows blood to flow through the valve even when delivery head 220a is inserted.

With the tool 200a in position to support the hooks in contact with the annulus, the operator drives the hooks 120 of the valve support 100 together into all of the loop positions to which it will be attached, by giving additional push, as shown in fig. 8C. In some instances, it may be possible for an operator to intentionally tilt the delivery head so that some hooks penetrate tissue in front of others. The configuration of the valve support 100 and tool 200a and the manner of temporarily attaching the attachment support 100 to the tool 200a tend to ensure that the hooks 120 will only pierce the valve 16 at the correct location along the outer edge of the annulus 18.

Once the valve support 100 has been attached to the valve 16, the operator pulls on the proximal end 240a, causing the delivery head 220a to evert (in phantom) and be withdrawn from the valve 16 (as shown in fig. 8D). Eventually, the everted portion of the tool 200a reaches the valve support 100. By pulling further, the operator wraps the receptacle portion of the support 100 around its periphery, which causes the free ends of the hooks 120 to be securely tucked into the annulus 18 of the valve 16, as shown in fig. 8E, thereby permanently positioning the support and allowing tissue to later grow around the support 100. The depth and radial extent of each of the deployed hooks 120 may be substantially the same as a conventional suture such that their deployment may be as effective and familiar to operators and others as a conventional suture.

With final pull, the operator breaks the connector 246 between the tool 200a and the valve support 100 and retracts the catheter shaft 210, leaving the support 100 in place. The catheter shaft 210 is retracted to a position beyond the valve annulus 18 and the cable is advanced in a first direction, allowing the delivery head 220a to assume its original conical shape (fig. 8F). The catheter shaft 210a is then retracted into the sheath 280 (fig. 8G) and the tool 200a is withdrawn.

In some examples, as shown in fig. 8H and 8I, when inverted, the tip 228a of the tool 200a has a compressed dimension that is less than the inner diameter 284 of the sheath 280, allowing the catheter shaft 210a to be retracted directly into the sheath 280 after deployment, while the inverted tip remains within the collapsed delivery basket, as shown in fig. 8I.

As the tool 200a is withdrawn, the valve support 100 contracts, thereby reshaping the annulus 18 to cause the valve leaflets 14 to coapt to prevent backflow of blood during contraction.

Other embodiments are within the scope of the following claims.

For example, a deformation of the tricuspid or mitral valve may be corrected. For a tricuspid valve repair, the hooks may be placed around only about three-quarters of the support and, thus, the annulus. In the placement procedure, the operator will turn the support to position the hooked portion of the support. For mitral valve repair, the hooks may cover the entire circumference of the annulus. In this case, the hooks are arranged around the entire circumference of the support. Alternatively, the hooks may cover only the posterior portion of the annulus of the mitral valve. In this case, the hook may be disposed around two thirds of the support member. Similar to the example of the tricuspid valve, the operator will position the hooked portion of the support against the posterior portion of the mitral annulus. Further, for mitral valve repair, a replacement valve may be provided as part of the delivery tool to maintain cardiac function during the delivery procedure. In addition to shape memory materials, other materials may be used as the material for the support body, and other methods may be used to force the support to the desired size after deployment, including, for example, a transverse bar across the opening of the support.

In addition, the left atrial appendage of the heart may be closed by a similar procedure. For example, a tool may be pushed into an opening of an atrial appendage to cause the opening to assume a predetermined shape. The tool may continue to be pushed in order to embed the hooks of the deployed support in the perimeter of the opening of the accessory. The tool is then withdrawn, thereby releasing the support and allowing the support to retract. The support may have a relatively small contracted diameter so that when the tool is withdrawn, releasing the support, the support may contract to a relatively small size, effectively closing off the attachment.

In addition to opening the heart and percutaneous deployment procedures, the valve support can also be deployed through the chest.

The head end of the tool need not be a basket, but may take any form, mechanical configuration and strength that enables the valve annulus to be forced open to a shape corresponding to the shape of the support. The basket may be made from a wide variety of materials. The basket may be held and pushed by utilizing a number of structural mechanisms that allow pushing and pulling on the support to position and embed the support in the annulus tissue and disconnect the support from the tool.

The tool need not be tapered.

The support member may take on a variety of configurations, sizes and shapes, and may be made of a variety of materials.

The hooks may be replaced by other means to locate and engage the support member by the thrust of the tool.

The hooks of the support need not be embedded directly in the circumferential band, but may be embedded in adjacent tissue, for example.

The support may take other forms and be attached in other ways.

In fig. 9A, the support body 110a may be a flower holder in the form of a coil spring (as previously mentioned). Such a support body may have a natural circumference 116 of about ten centimeters in its contracted state, and a proportional natural diameter 114. The circumference may be selected based on the physiological requirements of a particular patient.

An enlarged view of a portion of the support body, fig. 9B, shows some embodiments having a large number (e.g., a large number or a very large number, e.g., at least 15, or 100, up to hundreds or even thousands) of barbed hooks 120a attached to the outer surface 111 of the support body 110 a. In the example shown in fig. 9B, the helical strut body is wound from a flat strip having an outer surface 111 and an inner surface 117. Although fig. 9B shows the bur hooks attached only to the outer surface, the bur hooks may also be attached to the inner surface for manufacturing reasons or other purposes.

The barbed hooks, which are small relative to the body, are each configured to partially or fully pierce looped tissue when the portion of the body to which the barbed hooks are attached is pushed against the tissue.

As shown in fig. 9C, in some examples, each burr hook 120a has a sharp free end 122a for piercing tissue and at least one barbed end 128a, 128b (two shown in fig. 9C) for retaining the burr hook embedded in tissue. Each burr hook also has an end 124a attached to a surface of the support body. The embedded barbed hooks maintain the proper position and configuration of the body on the circumferential band once the support (we sometimes simply refer to the support structure as a support) contacts the heart tissue. The barbed hooks may be attached to the surface of the buttress body using glue, cement, or other types of adhesives, or formed as part of an industrial process such as molding, etching, die cutting, welding, or other processes, or may be attached by a combination of these techniques. Different burr hooks on a given support may be attached by different mechanisms.

Each barbed hook 120a may be configured and attached such that free end 122a points in direction 122b (or some other selected effective direction, or intentionally in a random direction) perpendicular to body surface 111. In some cases, the barbed hooks may be curved. The barbed end 128a may be located on the concave edge 113 (fig. 9D) or convex edge 115 (fig. 9E) of a curved-burr hook.

The bur hooks are similar to bur hooks on plant barbs in nature. Different types of attachment means can be used in a similar manner for metal tip hunting arrows, where the sharp point has two wide and sharp shoulders that cut tissue when it enters. The tips of the two shoulders have a function similar to barbs to keep the arrow embedded once it has entered the tissue.

In some embodiments, the burred hooks on the support body have two or more (in some cases, many) different shapes, sizes, orientations, materials, and configurations. By changing the orientation of these features, such as the barbed hooks, at least some of the barbed hooks will be more likely to embed in tissue regardless of the orientation of the support body as it contacts the circumferential band. Varying the number, orientation and curvature of the hooks may make it more likely that the support body will remain in place. For example, in such a support, a force applied to the support body in a particular direction may exit or partially exit some of the bur hooks by disengaging the barbed ends from the tissue, but the same force may not affect other bur hooks that orient the barbed ends in a different direction or different configuration than the exiting bur hooks. The force applied to position the support member may cause some of the barbed hooks to embed more securely than others.

In use, typically not all (in some cases not even most) of the burred hooks will embed themselves in the tissue as the buttress body is pushed against the tissue or remains embedded after deployment. As shown in fig. 9F, there are enough barbed hooks positioned in a proper manner so that only a portion of all the hooks must be embedded in the looped tissue (and in some cases only in certain areas) to create a physical engagement to hold the buttress body in place. The proportion of barbed hooks on the support that must be securely embedded in the tissue may range from 1% to 10% or 40% or more. The average spacing of successfully embedded barbed hooks may range from, for example, one hook per millimeter of length of the support body to two or three or more millimeters (or more) of a barbed hook to properly secure the support. When the barbed hooks are grouped rather than evenly placed on the support, the proportion of hooks that are successfully embedded and the distance between the hooks may be different.

When the barbed hooks contact the looped tissue during delivery, some but not necessarily all of the barbed hooks 131, 133 pierce the tissue and their barbs grip the tissue (when a retraction force is applied to the delivery tool). Of the remaining burred hooks, some of the hooks 135, 137 may not even contact the tissue (because of, for example, the contour of the tissue), while other hooks 139, 141 may not have sufficient force or contact the tissue in the correct direction to penetrate the tissue and have their barbs securely positioned in the tissue. Some of the barbed hooks 143, 145 may pierce tissue but not grip tissue. Some burr hooks 147, 149 may only pierce tissue at the barbed end 128a and not about the free end 122a, thereby providing a physical engagement that may be weaker than if the free end had been embedded in tissue. However, for some or many or most of the bur hooks entering the tissue, the barbed end 128a is properly positioned and resists forces in the direction 151 that would otherwise exit the bur hooks. Even though the clamping force applied to a particular burr hook in direction 151 may still be large enough to exit the barbed end, the combination of many burr hooks embedded in the tissue generally tends to keep the buttress body set in place and in the proper configuration. Over time, some of the bur hooks that are not embedded may become embedded when the support is deployed and some of the embedded bur hooks may become dislodged when the support is deployed.

The resistance provided by each barb to removal of a given barb hook from tissue may be relatively small. However, the total resistance of the barbed hooks to successfully embed themselves will be higher, and thus the support body and annulus of the valve can be reliably held in place in the desired shape. Furthermore, because there are many (possibly very many) small barbed hooks spread over a relatively large area, the stress on any part of the tissue of the annulus is quite small, which helps to keep the support body properly positioned and the proper valve shape properly maintained along its entire circumference without damaging the tissue. The fact that a large number of bur hooks, closely spaced, can be embedded along the length of the support means that the support can be attached to the switch more evenly and continuously than in the case of the relatively smaller number of hooks described previously, and therefore perform better.

With respect to the embodiment initially described with respect to fig. 1A, the embodiment illustrated initially at fig. 9A tends to have more and smaller hooks, not all of which must become successfully embedded. The common idea between the two configurations is that when a pulling force is applied at the end of the deployment process, the hooks pierce by being pushed into the tissue and have such a shape that the retaining elements become firmly embedded in the tissue. The two concepts are not mutually exclusive. A support member similar to that shown in fig. 1A may also have barbed hooks, and a support member similar to that shown in fig. 9A may also have hooks of the type shown in fig. 1A. The arrangement of the support may depend on a combination of the two types of hooks.

Each barbed hook may be formed from a biocompatible material such as platinum, gold, palladium, rhenium, tantalum, tungsten, molybdenum, nickel, cobalt, stainless steel, nitinol and alloys, polymers, or other materials. As for the hooks shown initially with respect to fig. 1A, the hooks can also be formed from a combination of these materials. Individual support bodies may exhibit bur hooks with a range of compositions. Some of the barbed hooks attached to the support body may be constructed of one material or a combination of materials, and some of the barbed hooks may be constructed of other materials or combinations of materials. Each burr hook may be unique in composition. Further, some portions of the barbed hooks may be constructed from one material set and other portions may be constructed from another material set. In some examples, the field of the barbed hooks at the barb tip is comprised of one set of materials, alloys, polymers, or mixtures, the field of the barbed hooks at the free end is comprised of another set of materials, alloys, polymers, or mixtures, and the remainder of the barbed hooks are comprised of another set of materials, alloys, polymers, or mixtures. Fig. 9G shows an exemplary burr hook having only one barbed end 128 a. The burr hook extends from the attachment end 124a to the free end 122a along the path of the major axis 920, which major axis 920 is (in this case) perpendicular to the support body surface 111. The barb end spans a length 904 from the free end 122a of the barbed hook to the free end 906 of the barb end. The free end 906 forms a point that spans an acute angle 910, and the barbed end 128a spans an acute angle 911 to grasp tissue in response to any force that would otherwise pull the embedded barbed hook away from the tissue.

The length 901 of each barbed hook as measured from the attached tip 124a along the major axis to the free end 122a may be between about 1 and 12 millimeters. Each barb end may extend from the barbed hook a distance 902 that is less than or greater than the major width or diameter 903 of the barbed hook as measured at the attachment end. The body of the barbed hook may be planar or cylindrical or oval in cross-section or any other of a variety of shapes.

Different barbed hooks may be arranged on the support body surface in different sizes and configurations. For example, different barbed hooks may have different lengths and different numbers and barb tip arrangements. As shown in fig. 9H, for example, a portion of the support member body surface 111 comprises barbed hooks 120a and shorter barbed hooks 120b, wherein the barbed hooks 120a each have two barbed ends 128a, 128b facing in a first direction 950 and the barbed hooks 120b each have one barbed end 128a facing in a second direction 951. Likewise, the bur hooks can be disposed on the body surface in various densities and distribution patterns. For example, as shown in fig. 9I, the bur hooks can be arranged in repeating rows 930 on the surface of the body. As shown in fig. 9J, the bur hooks may be arranged on the surface of rows 931, 932 of different lengths and densities. As shown in fig. 9K, the bur hooks can be disposed on a surface along an arc 933. As shown in fig. 9L, the bur hooks can be arranged on the surface as a tuft pattern 934. As shown in fig. 9M, the bur hooks may be randomly 935 distributed. Other patterns may also be used.

A unitary support body may include various patterns of burred hooks on its surface, as the physiological characteristics of a particular heart valve may mean that the valve tissue is either more or less receptive to a particular distribution of burred hooks. Some patterns may be more effective for some types of tissue, while other patterns may be more effective for other types of tissue.

In addition, as shown in fig. 9N, the barbed hook is not present at the location where body 110a contacts delivery tool 220, including in the vicinity of rigid fingers 256, 258. This tends to prevent the barbed hooks from causing the support body to adhere to the tool.

As shown in fig. 9O, any two barbed hooks may be disposed spaced apart from each other by a distance 905 that is greater than or less than length 901 or 901 a.

As shown in fig. 9P, when the support is helically formed, the annulus can be considered to have an anterior side 961 (which faces the valve when the support is delivered), and a posterior side 960 facing away from the valve. In some examples, the support body 110a does not have a barbed hook 120a on the back side 960. In these embodiments of the support body, the rear side 960 is covered by a sleeve 963. After the support body has been attached to the annulus, the sleeve contributes to the long-term process of bonding with the valve tissue. Over a period of time, the heart tissue will be attached to the support body as part of the treatment process. The sleeve is made of a material that allows the process to occur faster than without the sleeve. For example, the sleeve may also be composed of a porous material, which allows tissue to grow into the sleeve, thereby securing the buttress to the tissue more effectively than would be the case without the sleeve. The sleeve material may be a thermoplastic polymer such as Dacron (polyethylene terephthalate). The sleeve material may alternatively be metal or other types of material. The sleeve may be located on the support body at a position other than the rear side. For example, the sleeve may be located on the inside 965 of the body while the barbed hooks remain on the outside 964.

In this example, the sleeve is formed as half of a receptacle, but has a number of other configurations. Such a sleeve may be used for any type of support, including as initially shown in fig. 1A, may cover all or only part of the support, may cover part of the support including hooks or barbed hooks, or both. In the latter case, the hooks may be arranged to pierce the sleeve during installation and before the support is arranged to the heart. The sleeve may also cover a portion of the support device to contact delicate or sensitive tissue, such as AV nodes. In this case, the sleeve is made of a material that is less likely to damage or interfere with delicate or sensitive tissue than other materials that may be used for the buttress.

The use of barbed hooks may allow for faster, simpler, more reliable, and easier attachment of the support than the larger hooks described above. The delivery tool operator may not have to apply as much force as is required to embed larger hooks in the loop tissue. In some cases, the barbs may not have to be rotated as described for larger hooks in order to securely embed them. The operator does not have to worry about whether all the bur hooks have become embedded. Once the operator has determined that the buttress body has contacted tissue and by presumption that many of the bur hooks have become attached, the operator may pull on the buttress to verify that it has been positioned and then release the buttress body from the delivery tool using one of the previously described mechanisms. Due to the ease of positioning, the procedure can be performed more easily in non-surgical situations, e.g. in a catheterization laboratory.

As shown in fig. 13A-13D, in the case of catheter insertion, the catheter may include a balloon 228b at the tip of the delivery tool for a deployed bur hook support or any other type of support. The balloon remains deflated as the catheter passes through the patient's blood vessels into the heart, as shown in fig. 13A. When the tip of the catheter reaches the heart, the balloon may be inflated, as shown in fig. 13B. The inflated balloon floats in the blood to be pumped through the heart and is easily and to some extent automatically conveyed toward and into the valve to be repaired. The balloon may continue to move beyond the valve annulus and, when positioned as shown in fig. 13C, support the distal end of the catheter while the operator supports the proximal end of the catheter. The shaft of the catheter then acts as a "rail" for support at both ends, and along it the operations involving the delivery tool and support can be performed with confidence that the rail remains substantially on the shaft with respect to the valve.

In some of the previously described examples, the annulus of a heart valve is deployed to a desired shape by pushing a conical surface, such as a basket, along the axis of the valve and into the heart valve. If delivery is to be performed in the case of open heart surgery or in a catheterization laboratory or elsewhere, the pushing of the conical surface into the annulus may be supplemented or replaced by a technique in which the expansion of the annulus is performed after the delivery tool has been inserted into the valve.

Fig. 9A shows one diameter of the support body, the natural (long-term configuration) diameter 114. Again, this diameter is different from the diameter in the delivery configuration. The natural diameter 114, as shown in fig. 9Q, is less than the diameter 202 of the delivery tool in the delivery configuration of the support body attachment location 247. When the support body is disposed on the delivery head 220, the coils of the coil spring expand outward as the body is deployed to fit on the tool.

During delivery, as shown in fig. 13A-13D, when the support body has been attached to the circumferential band 18, the operator releases the support from the delivery tool. Figure 13D shows that in the absence of the outward force first applied by the delivery tool, the coils of the coil spring contract inward 1308 to return the support body to a final diameter 1309 that is approximately equal to its natural diameter. Referring again to fig. 1H, note again that because the cuff is attached to the support body, the support body will also pull the cuff inward, thereby shaping the cuff to the desired smaller diameter 209.

If the support body is made of a substantially plastic material or alloy, the support body may not fully contract to its original natural diameter. However, if the support body is made of a shape memory alloy, such as nitinol, the memory effect of the alloy will tend to cause the support body to contract to a diameter that is nearly equal to or equal to its original diameter.

As shown in fig. 9R, the supporter body 110a may have other portions without burred hooks. As mentioned previously, sensitive or delicate tissue such as AV nodes should not be punctured or interface with hooks. In some examples, the support body 110a can have an engaging portion 972 with barbed hooks and a non-engaging portion 974 without barbed hooks. A sufficient length of the non-engagement portion 974 adjacent the AV node spans an angle 975 of between about 40 and 60 degrees of the circumference of the support body. The engagement portion 972 will span the angle 973 of the remaining circumference. In some examples, the non-engaging portion 974 is covered in a sleeve made of a material suitable for contacting the AV node or other sensitive tissue.

As shown in fig. 9S, the two portions 972, 974 may have radiopaque markings 976, 977 indicating the boundary between the two portions. The marks 976, 977 are each in the shape of an arrow pointing to the non-engaging portion. During delivery, the operator may use the radiopaque markers 976, 977 to view the boundaries of the nonjunction portion 974 and position the nonjunction portion 974 against an AV node or other sensitive tissue.

As shown in fig. 9T, the support body 110a can have multiple portions 974, 978 without barbed hooks. In some cases, the operator may be limited in the angle at which the delivery head can be rotated. In this example, the operator has multiple options for positioning the support body to avoid puncturing the AV node, without the operator having to rotate the delivery head more than about 90 degrees in any direction. Two non-engaging portions are shown, but the support body could equally have three or more of these portions. The non-engaging portions 974, 978 span an angle 975, 979 of between about 40 and 60 degrees of the total circumference. In the case of two non-engaging portions, there will also be two engaging portions 980, 982 spanning the remaining two lengths of the circumference at angles 981, 983.

As shown in fig. 9U, the feature of the support body 110a that should abut the AV node may take the form of an open portion 990. As with the non-engaging portions described above, the opening portion 990 may span an angle 995 between about 40 and 60 degrees of the circle defined by the support body 110a, while the support body spans the remaining angle 993. The open portion 990 may also have radiopaque markings on the open ends 992, 994 of the support body 110a to assist the operator in positioning the open portion 990 against the AV node or other sensitive tissue.

As shown in fig. 10A-10D, the delivery head 220 can include a sheath 280A for covering the support body during insertion. Fig. 10A and 10B show the sheath in side section, and fig. 10C-10D show the sheath and delivery head in cross section at a-a in fig. 10B. Sheath 280a wraps around delivery head 220, including support body 110a, so that the bur hooks do not accidentally pierce or attach to any other tissue or device prior to reaching the circumferential band. The sheath is made of a flexible material such as rubber, silicone rubber, latex, or other biocompatible material or combination of materials. The sheath may also be made of the same material or materials as the catheter. It is again noted that one embodiment of a sheath is shown in fig. 6A-6B and described in corresponding text. Other embodiments of the sheath are also possible.

For example, the embodiment of the sheath 280A shown in the side cross-section of fig. 10A is held in place by attachment perpendicular to the longitudinal axis 234 to a resilient retaining ring 1000 and a crossbar 1010 permanently affixed by the catheter shaft 210 and extending outwardly from the catheter shaft 210. The retaining ring 1000 is positioned closer to the operator and further from the distal end than the support body 110a, and the crossbar 1010 is positioned further from the operator and further from the distal end than the support body. The sheath 280a is permanently attached 1002 to the retaining ring 1000. The sheath 280a is also temporarily attached to the crossbar at apertures 1030, 1032 (visible in fig. 10B), wherein the apertures 1030, 1032 are sized to fit the protruding tips 1020, 1022 of the crossbar 1010.

As shown in fig. 10B-10D, the combination of the retaining ring and crossbar allows the sheath to automatically separate from the crossbar and retract upward away from the support body as part of the deployment procedure after the catheter is inserted into the valve and when the delivery head is deployed in preparation for attachment of the support body 110 a. The process proceeds as follows.

Referring to fig. 10B, as the delivery head is deployed outward 1006, the diameter 1008 of the delivery head at the origin 1012 of the retention ring attachment increases to a diameter greater than the diameter 1009 of the retention ring 1000. As a result, the retention ring is wound 1004 up from point 1012 to point 1005 on the smaller diameter delivery head. As the retaining ring is wound, it pulls the distal end of the sheath in the same upward direction 1004 along the delivery head 220 and away from the support body 110 a. As part of the winding process, a portion of the sheath 280a wraps around the ring; in a sense, the retaining ring "winds up" the sheath in a wrapping manner around the winder spool. The retaining ring 1000 is rubber or other biocompatible material that is sufficiently resilient to allow the ring to be rolled up the deployed delivery head.

The sheath 280a is likewise released from the crossbar when the delivery head 220 is deployed. A cross-section of delivery head 220 including crossbar 1010 is shown in fig. 10C. When the delivery tool is delivered to the heart valve, delivery head 220 is in a collapsed/contracted configuration. The sheath 280a has apertures 1030, 1032 configured to allow the cross-bar 1010 to pass therethrough, thereby retaining the distal end of the sheath to the cross-bar. Because the crossbar protrudes beyond the sheath, the ends 1020, 1022 of the crossbar are rounded and smooth to prevent the crossbar from puncturing or tearing any tissue it contacts before the delivery head reaches its destination. Once the delivery head is positioned near or inside the heart valve and begins to deploy 1006 outward from the shaft 210, the delivery head pushes the sheath 280a outward.

During the deployment process, as shown in fig. 10D, the crossbar remains in place and does not extend outward or change configuration because the crossbar is permanently and securely attached to the shaft 210. As a result, the delivery head pushes the sheath over the tips 1020, 1022 of the crossbar, thereby releasing the sheath from the crossbar. In this way, the sheath is free to move as the retaining ring is wound up along the delivery head, as described above. The crossbar 1010 may be made of any material for the delivery tool, or other biocompatible material, as long as the crossbar is sufficiently rigid to hold the sheath 280a in place, as described.

Fig. 11A shows another version of delivery header 220 b. This version is slightly different from the version of the delivery header that has been shown. Specifically, in this version 220b, the rigid protrusion 216b consists of an outer sleeve 1140 that surrounds an inner arm 1142 attached to the shaft 210b by a hinge 1144. Sleeve 1140 extends from interior 1142 when the delivery head of this version is deployed, and exits along the length of the inner arm when the delivery head is retracted. This version of the delivery head is used in fig. 11A to demonstrate the use of a pull-up cable 1100, but the pull-up cable may also be used with other versions of the delivery head.

As shown in fig. 11B, the pull-up cable 1100 is threaded to and back out of the hole 1103 at the operator end 214B of the delivery tool 200B. By doing so, the cable traverses back and forth across the interior of the shaft portion 210b of the delivery tool 200 b. The end of the cable outside of the operator end 214b forms a loop 1102 that is manipulated by the operator. This cable 1100 can be used to actuate a mechanism to adjust the shape of the support body 110a to a small extent for the purpose of contracting the final diameter 1309, an example of which is shown in fig. 13B. Referring back to fig. 11A, at the other end of delivery tool 200b, the cable exits shaft 210b at a hole 1105 disposed at a location above delivery head 220 b. The cable is guided along the sides of delivery head 220b by hoops 1120, 1122. As shown in fig. 11C, the cable spirals along the inside of the helical coils 1150, 1152 of the support. At a location 1164 where the cable has completed one turn of the support body 110a, the cable returns up the side of the delivery head and back into the stem.

Fig. 11C also shows hoops 1124, 1126 arranged at regular intervals on post 224b of the delivery head to keep the cable properly positioned. At a location 1164 where the cable meets itself and returns up the side of the delivery head, spools 1130, 1132, 1134, 1136 attached to post 224b guide the cable and prevent it from scraping 1160, 1162 the helical rings 1150, 1152 at the cable exit area. The end of the cable that again enters the hole 1105 (fig. 11A) continues to bear against the shaft next to itself and exits the delivery tool (fig. 11B) to form the loop 1102 by connecting the other end.

When the support body 110a is securely positioned over the heart valve annulus 18 (e.g., in the situation shown in fig. 13C), the operator may pull 1104 the ring 1102 (fig. 11B) to reduce the final diameter of the support. When pulled, the cable is tightened; this brings the coils 1150, 1152 of the 1106 support closer together as shown in fig. 11C.

The adjusted circumferences permanently become the burred hooks of the buttress embedding themselves in the annular tissue. Although some of the barbed hooks have been embedded, the tightening procedure will pull out some of those barbed hooks and other barbed hooks that are embedded in the tissue. This "ties" the cuff tissues closer together. FIG. 11D shows an example of a portion of the support body 110a attached to the periphery 121 of the cuff before the support body is tightened. As shown in fig. 11E, upon tightening, the buttress body 110a pulls the tissues at the periphery 121 closer together. The final diameter of the cuff will be slightly smaller due to the binding effect. Once the delivery head is removed, the support body, and thus the attached circumferential band, will contract to the desired size.

Referring to fig. 11F, to separate the cable from the support body 110a, the delivery head 220b has a blade 1170 attached to one of two rigid fingers 256b, 258b that hold the support body in place. When the rigid finger 256b is pulled away from the support body 110a after the support body is in place, the cutting portion 1172 of the blade structure severs the cable. The operator can pull on the outer ring after the cable has been severed to prevent the stray end of the cable from moving freely outside of the delivery tool when the tool is being removed from the annulus.

As shown in fig. 12A-12C, a delivery tool 200b for use in (but not solely) a catheterization situation has common elements with the previously discussed delivery tools, including a shaft 210b, a collapsible conical head tip basket 220b, a set of struts 224b, and an operator tip 214 b. This delivery tool 200B allows the operator to expand or contract the collapsible conical head end basket 220B from a collapsed (closed) configuration (as shown in fig. 12A) to an expanded (open) configuration (as shown in fig. 12B), much like the way an umbrella is opened. For this purpose, the basket may include a set of rods 1210, 1212, 1214, 1216, 1218 disposed about the shaft, as shown in fig. 12C. Referring back to fig. 12B, each rod has one hinged end 1220, 1222 connected to a central hub 1200, which central hub 1200 can slide up and down along the central rod-like portion 1250 of the basket. Its other hinged end 1230, 1232 is connected to the basket's hinges 1240, 1242 strut 224b so that when the opening and closing mechanism is manipulated 1208 by the user to cause the bushing 1200 to move back and forth along the shaft 1250, the rods 1210, 1220 force 1206 the basket to open or close, similar to the umbrella's mechanism. The operator end 214b of the delivery tool has a twist or slide control 1150 that enables the operator to control the bushing. In fig. 12b, the control is a sliding control and may, for example, slide downwards. In this way, the annulus may be expanded to a desired shape by radial forces 1206 not applied by moving the entire basket linearly along the valve axis. Instead, the basket is moved linearly along the valve axis to the desired position, and then the annulus is deployed to its desired shape. Radial forces may also be applied by axially moving the entire basket and laterally expanding the basket in combination or in sequence.

As shown in fig. 13A, the radiopaque measurement markers 1310, 1312 may be arranged on the shaft or basket at regular intervals according to standard units of measurement (e.g., one marker per centimeter). The markers may be used to determine the distance the delivery tool has traveled inside the heart and the position of the basket when inserted into the valve, allowing the operator to place the basket in a good position along the valve axis.

The arrangement of the support from the basket to the annulus may be performed as part of the operation of opening the basket or after opening the basket. In the former case, the basket will be inserted into the valve to a position where the basket is adjacent to the valve annulus, as shown in figures 13A-13D. Simultaneous with the opening of the basket, the burred hooks on the outer periphery of the support will be forced radially into the annulus tissue. In this method of arranging the support, the porous sleeve described previously and shown in FIG. 9P will be positioned on the inner perimeter 965, away from the embedded hooks.

In another procedure, similar to the procedure shown in fig. 1A-1D, the basket will be inserted into the valve such that the support on the basket is positioned slightly upstream of the annulus location. The basket will then open to force the loop into the desired shape and then the tool and basket will be pushed slightly to force the support into position, embedding the hooks.

In either procedure, once the support is deployed, the basket will be at least partially closed, thereby releasing the basket from the support, and the tool will be withdrawn from the valve.

Further, in some embodiments, a combination of the described procedures may be used. For example, the basket may be partially opened, inserted into the annulus, and then fully opened.

The process of FIGS. 13A-13D follows these steps:

A. position 1301 (fig. 13A) the collapsed (closed) conical head end basket 220b of the delivery tool 200b is at the central axis 30 of the valve, while the support is adjacent to the annulus. (tools and baskets are shown in side view, while the valve and annulus are shown in cross-sectional side view.)

B. A button 1302 is pressed on the operator's tip 214b to inflate the balloon 228b (fig. 13b) on the distal end 230b of the delivery tool, allowing the delivery head 220b to float to the correct position in the heart valve 16. If necessary, the delivery head is rotated to align any portion of the support body that is free of burred hooks, or any portion of the support body that is reduced or surrounded by a sheath, with any portion of the annulus that abuts delicate or sensitive tissue.

C. Sliding 1208 or twisting the control member 1150 to deploy 1306 the basket so that the support body 110a contacts the deformed annulus 18. The supports bear barbed hooks that embed themselves in the valve tissue at the periphery 121 of the annulus 18 when in contact, thereby attaching the supports to the tissue (FIG. 13C).

D. When the basket 220b has reached the desired diameter 1303, the deployed heart valve support 110a forces the annulus 18 to follow the desired configuration (e.g., circle) and size (e.g., diameter) greater than the desired final diameter of the annulus. Optionally, the cable loop 1102 is pulled 1104 up the coils of the support body 110a to achieve a smaller final diameter.

E. To disconnect the tool from the support attachment 246b when the heart valve support is in its final position, pull 1304 (fig. 13D) allows the support to contract 1308 to its final size (including final diameter 1309) and shape and leave the support permanently in place to hold the annulus in the desired final configuration and size. The soft bladder 228b is deflated 13 by squeezing a button at the end of the operator.

In some embodiments, as shown in fig. 14A-14D, the support member is constructed of several pieces, including a resilient multi-loop circular coil 302 of strip material 304. The coil is housed in a tubular annular sheath 306. A large number of barbs or hooks 308 (which may be, for example, between 20 and 60, but may also be much larger in number, even on the order of magnitude larger, or in some cases less) are mounted at regular small intervals 310 around the circumference of the annular sheath.

In some embodiments, the multi-loop circular coil is made of nitinol strips, about 1/8 inches wide and about 10/1000-15/1000 inches thick. The nitinol strip is shaped during manufacture into a coil having the final desired implant diameter. For insertion purposes, the nitinol coil will be deployed, as explained later. During deployment, the ends 312, 314 of the band will move circumferentially around the coil (in the directions indicated by arrows 316 and 318) to accommodate the increase in diameter of the loop. In fig. 14A-14D, the ring is shown in its natural unstressed diameter corresponding to the final desired implant diameter. The number of rings may vary depending on the material used, the thickness, and other considerations. In some embodiments, the number of rings may be 3.5 or 5 or 8, or other numbers from 1 to 10 or greater.

In some embodiments, other materials and combinations thereof may be used to form the elastic coil. These may include, for example, plastic, metal, and coils of these and other materials.

In some embodiments, the overall shape of the coil may be different than that shown in fig. 14A, including non-circular and non-planar shapes.

The coil (or other elastic core ring) needs to be of sufficient strength and durability to be able to expand to fit over the delivery tool, to be forced onto the heart valve annulus, to contract to pull the annulus back to the desired shape, to tolerate the forces generated when the insertion tool is broken, and to create a long-term and strong support for the annulus. It also needs to be sufficiently elastic to be able to contract the support and the annulus to which it is attached to the desired shape and size after insertion and to substantially maintain the shape and size of the support against the forces acting in the heart against the support.

In some embodiments, biocompatible materials are used if it is possible to expose the material from which the coil is made to the patient's blood or tissue.

The coil is held within the sheath 306 such that the coil is allowed to slide within the lumen of the sheath, particularly when the coil is deployed for insertion and retracted after insertion. The sheath has an elasticity that allows it to move radially with the coil during deployment and retraction. Because the barbs or hooks (we sometimes refer to barbs and hooks, and various other gripping devices, as grips) are mounted on the sheath, rather than on the loops, the expansion and contraction of the loops can occur without disturbing the angular position of the grips relative to the central axis of the support member.

In some embodiments, the sheath may be formed from a simple tube. To embed the coil in the tube, the coil may be unwound and repeatedly wrapped through the tube until all turns of the coil have been embedded. Once the coil is fully embedded, in the tube, one end of the tube may be pulled and glued to the other end to complete the assembly.

In some embodiments, the sheath may be formed from a special moulding having a ring shape formed during the moulding process and including a means of securing the two ends together.

In some embodiments, the sheath is intended to be sealed to prevent fluid flow into the chamber containing the coil. In some cases, the sheath is not sealed and fluid can freely pass through. In some embodiments, a fluid is used to fill the space in the sheath to provide lubrication for the coils to slide within the sheath and displace air, which can cause problems when the support is used inside the heart. The fluid may be, for example, blood or saline solution.

The sheath must be strong enough to surround the coil without breaking, even when the support is deployed and retracted during and after deployment in the valve. As the diameter of the support expands and contracts, the cross-sectional diameter will be at least the same: tends to vary, wherein the amount of variation does not have to be too great to interfere with the attachment of the grip to the valve tissue; limiting the sliding of the coil within the sheath; or to allow the grip to be dislodged or redirected relative to the sheath. The sheath may be resilient such that when the support contracts after deployment, the sheath contracts with the coil.

Various materials may be used for the sheath, including, for example, silicone, plastic, and plant. Combinations of materials may also be used.

As shown in fig. 14D, the outer surface 322 of the sheath can have a groove 323 that receives (and holds in place) a portion of the grip, as explained below. In some embodiments, the grooves may be parallel and positioned at equal small intervals around the perimeter of the sheath.

The sheath may have a cross-sectional diameter that is large enough so that the lumen receives the coil and allows it to slide, and an outer surface that supports the grip, and may be small enough so that the support does not impede sufficient flow of blood through the heart valve after installation.

As shown in fig. 15, in some embodiments, each grip may be formed over the length of the cable including a closed loop 324 having a diameter 326 that is nearly the same as the diameter of the cross-section of the sheath (or slightly smaller). A straight portion 328 extends from the ring and has a catch 330 formed on its free end.

We refer to the entire member including the grip and the portion attaching the grip to the support member as the anchor 332 at times.

In some embodiments, the final shape of the anchor is pre-formed into a loop and a grip protruding from the loop. In some examples, the anchor is formed of stainless steel or other biocompatible material.

Various materials and combinations thereof may be used to fabricate each anchor or group of anchors, including metals and plastics. The cross-sectional shape of the anchor can vary and can be, for example, circular, oval, planar or curved, or various other shapes.

In some embodiments, the anchor may be formed by a small fishhook, with a hook end serving as a catch and another end bent to fit onto the support.

The thinner the anchor is in the direction along the circumference of the sheath, the more anchors can be fitted to the support. In some embodiments, a greater number of thinner anchors will be used to make the support easy to install and effective. In some cases, the arrangement of anchors along the sheath may not be regular and closely spaced. The spacing may vary along the sheath, or the number of anchors may vary, for example, along the sheath.

To install the anchor, its loop portion may be pulled open and slid over the sheath and then released. In examples where the outer surface of the sheath is molded with a groove, the ring portion of the anchor may be located in the groove.

In some examples, the anchors may all be mounted such that their grippers point at a common angle 336 from a central axis 338 of the support, as shown in fig. 14D (where some cats have not yet been mounted). In some examples, the grip may be directed at different angles relative to the central axis.

In some instances, the anchors may be mounted such that they do not tend to slip or rotate about the outer surface of the sheath, but rather maintain their mounting orientation. In some embodiments, as the support expands and contracts before, during, and after insertion into the valve, expansion and relaxation of the sheath results in a change in its cross-sectional diameter and thus opening and closing of the annulus and corresponding redirection of the angle of attack of the tip of the grip. This effect can be useful in installing and providing secure attachment of the grip in valve tissue.

In some cases, if all of the grippers share a common angle of attack of the tips, it may be undesirable to space the circumferentially sequential anchors too close 310, as adjacent gripper tips may interfere with each other during insertion and be less effective in gripping valve tissue. For this reason, in some embodiments, the angle of attack of the tips of the grippers may vary slightly from anchor to anchor, which will allow for closer spacing while still allowing for some clearance between successive grippers. In some cases, the guidance of sequential grippers may alternate back and forth about the centerline. Other configurations are also possible.

In fig. 14A-14D and 15, the anchors are shown as each having a single free end with a pointed end 340. In some embodiments, each anchor may provide an extension (e.g., a symmetrical extension) for the other end 342 of the cable, as shown by dashed line 344. Various other configurations are also possible.

In fig. 15, the grip has three barbs on each of the free ends of the cable. In some embodiments, more or fewer barbs may be employed, and the barbs may have various other configurations on the grip.

In some embodiments, each grip 350 may be formed of a cable or other cylindrical material, and may, for example, be shaped, machined or molded to have the configuration shown in fig. 16 and 17, including a tip 352 having two planes of symmetry 354, 356, each at an angle 358 of, for example, 25 degrees relative to a central axis 360 of the grip. Below the tip are two barbs that are formed by laser cutting, machining or otherwise applying slots 362 and 364 at a common angle (15 degrees in this example) relative to the central axis.

Once the barbs are formed, they may be bent away from the shaft in directions 366 and 368 to form the final barbs.

Various other configurations and forms of manufacture are possible for the barbs and the grip. In the particular example shown in fig. 16 and 17, the grip is formed from nitinol wire having a diameter of 1.26 mm and a length of 22.87 mm from the grip to the bottom edge of the slot.

As shown in fig. 14D, in some examples, each grip extends from about 2 mm to about 4 mm (dimension 339) from the bottom of the sheath surface when installed.

In some embodiments, the support, which includes portions of the coil, sheath, and anchor, is encased in a cloth covering as many existing rings are manually sutured to the valve annulus by the surgeon. The cloth allows the heart tissue to securely attach itself to the support over time, thereby creating a safe repair.

As shown in fig. 18, in some cases, the cloth cover may be a thin strip of material that is spirally wound around the rest of the support. The material may be sewn, glued or otherwise attached to the support. The helical winding allows for the use of inelastic materials and still accommodate the expansion of the circumference of the support member. In some examples, the cloth cover may include a series of individual tubular cloth portions disposed on a support. The arrangement of the portions will allow the use of inelastic cloth without hindering the expansion of the circumference of the support.

When the cloth is arranged on the support, it is pulled over the gripping members, each of which pierces the cloth and remains ready for insertion. Various covering materials or combinations thereof may be used, including metals, fabrics, and plastics. The covering should be able to accommodate the expansion and contraction of the support without becoming deformed, and should be biocompatible and sufficiently porous to accept and promote tissue growth through its structure.

Various other configurations of the parts and materials and ways of assembling the parts of the support are possible. A different number of pieces may be used and the described functions may be combined in different ways into different pieces of the support.

In some instances, as shown in fig. 19, 20 and 21, the sheath may be made of two interlocking molded pieces. An outer annular housing 402 (sometimes referred to as an outer piece) has upper and lower planar rings 404, 406 joined by an outer planar cylindrical wall 408. The coil 407 is located in the housing. The other inner piece 410 of the sheath is a cylindrical wall captured between the upper and lower rings 404, 406 so as to allow the inner end of the coil to be tightened or loosened by sliding it circumferentially 409, thereby allowing the support to expand or contract. During sliding, the inner piece of the sheath also slides circumferentially.

In this example, the anchor 412 is formed from a flat piece of metal that is bent and then attached to the outer piece of the sheath. Each anchor comprises an upper finger 417 gripping the upper part of the outer piece of the sheath, a vertical arm 419 and a lower finger 414 gripping the bottom of the outer piece of the sheath. The catch 416 extends downwardly from the lower finger. The inner piece of the sheath has tabs 418 that can be operated to pull or release the ends of the coil to expand or contract the support. The opposite end of the inner piece of the sheath is attached to the end of the coil for this purpose. As a result, the support member can be expanded or contracted without movement of the anchor relative to the outer member of the sheath. The tab 418 may be manipulated in a variety of ways, including by direct finger manipulation, using an insertion tool during open heart surgery, or at the tip of a catheter at a remote location in a catheter laboratory.

In some embodiments of the grip, as shown in fig. 22-27, there is a pointed tip 430 and, on each side of the pointed tip, there are pairs of barbs 432, 434, 436, 438. In the example shown in fig. 22 and 23, barbs 434 and 438 are smaller. In the example of fig. 24 and 25, the two barbs on each side of the tip are of similar size and shape.

In some examples, as shown in fig. 26 and 27, the detailed configuration of the nitinol strip includes a pointed end and a barb. As shown in fig. 21, in some configurations, the barbs are bent out of the plane of the strip from which the grip is formed in order to more effectively act as barbs.

In general, in some examples, a support embedded in valve tissue may be configured to perform three related functions: (1) once the support has been correctly positioned on the circumferential band, the grip of the support can be easily inserted into the tissue; (2) being able to securely hold the support in the tissue such that the annulus for the valve is maintained in the correct shape and is durable and long lasting, in part by providing significant resistance to forces that would cause all or part of the support to separate after insertion; (3) it would be useful if it were possible to intentionally withdraw all or part of the grip during or after the insertion procedure in order to reposition or reorient the support relative to the valve annulus. These three functions require careful and careful design of the grip, anchor and other portions of the support, as some design factors that favor one of these functions may negatively impact the other function. These functions should also be implemented in a simple, error-free and easy-to-use device.

For example, easier insertion of the grasping element into tissue can be achieved by reducing the size and contour of barbs on the grasping element and aligning the tip of the grasping element directly with the tissue. Removing some or all of the gripping members to reposition the support member will also be helpful. However, those same features can reduce the stability and durability of the attachment of the support to the tissue. By giving the barbs a wider or bulkier profile or aligning the tips of the graspers away from a direct path to the tissue, the grasp will become more secure, but inserting the graspers will be as difficult as repositioning.

Design features that can be adjusted and compromised to achieve a mix of desired functions include the number, shape, size, orientation, and mounting method of anchors, grips, and barbs, the shape, size, orientation, and other configuration of the body of the support, the materials used for all portions of the support, and various other factors.

In some cases, a mechanism or configuration may be provided that allows for an intentional reversible process for inserting and removing a grasping element in tissue for repositioning.

For example, as shown in fig. 28-31, the support 450 may include anchors, for example in the form of 30 rings 452, evenly spaced around the body 454 of the support. The cross-section of the body 454 may include a circular portion 456 along the inner periphery of the body and a planar or recessed portion 458 along the outer periphery of the body. Each ring may include two free ends 460, 462, one 460 of which is non-pointed and the other 462 of which has a sharp point. The ring does not have any barbed features.

In some modes of operation, prior to insertion, the curved sharpened tips 462 of all of the grippers can be held away from the body and aligned in the general direction of the annulus tissue. A sheath or other mechanism may be used to move them into and hold them in the temporarily inserted position. During insertion, an insertion tool may be applied to force the grip into tissue. Once the sharp distal end of the grip is in the tissue, the sheath or mechanism can operate to allow the anchors to assume their final shape after following the curved path 464 through the tissue 466 and exiting from the tissue to be positioned next to the support body, as shown in fig. 31.

This configuration has the advantages: the procedure can be reversed by using a similar sheath or mechanism to withdraw the grasping element through the tissue and back to the configuration of FIG. 30. This procedure is relatively easy to reverse because the grip is already through the bending of the shaft of the anchor rather than through the barbs on the sharp tip. Gripping is also ensured. However, insertion can become more difficult than in other embodiments, and reversibility requires an additional mechanism.

In some examples, the support may be provided with adjustment and locking features that allow the size (e.g., diameter) of the support, and possibly its shape, to be adjusted or locked or both by the physician or operator at the time of insertion. In some cases, the support may be adjusted to different possible sizes while being inserted, without it having to reach only a single, non-selectable design size.

For example, as shown in fig. 45, the core structure 570 of the brace may be made of crimped stainless steel that is plastically deformed by an insertion tool (not shown). The tool may engage the top of the structural member and force the member temporarily to have a larger diameter to facilitate insertion. After pushing the support into the annulus to attach the grasping element to the tissue, the tool may collapse and allow the diameter of the structural element to collapse to its final size.

As shown in fig. 46, in some instances, individual expansion elements 573, 575 will have holes 576, 578 with locations and spacings that exactly match the locations and spacings of pins 582, 584 in rigid locking element 580 once the structural member has been deployed or retracted to exactly the desired length. The locking element will be held in place in an annular silicone support having inner and outer peripheral walls 574, 576 joined by an upper annular wall 578. Pushing down on the silicone support when the support is properly sized will force the pin of the locking element into the hole.

Referring to fig. 47-53, in some embodiments, the support 600 may be formed of three pieces.

One piece, the annular elastic (e.g., silicone) ring 606 has a cross-section that includes four straight portions defining a trapezoid, which provides stability to the shape of the ring. With four respective faces of the ring. Face 632 may have a configuration designed to match the surface of the face of the dilator portion of the insertion tool.

The second of the pieces is a metal ring 604 formed from a strip of, for example, stainless steel, having a curved cross section and two overlapping ends 620 and 622. The curvature of the cross-section maintains the axial stability of the ring. Near one end 622, the ring has a series of slots that desirably engage corresponding tabs 623 formed near the other end 620. During manufacture and assembly, the tab ends of the ring are located inside the overlap 627 so that no mating and locking can occur. When finally installed, however, the tab ends are located outside the overlap to allow locking. During manufacture, the silicone ring is molded around the metal ring. When the silicone ring is stretched and relaxed, the metal ring can expand and contract because the two ends are free to move relative to each other at the overlapping portions. The support is substantially spring loaded.

The third piece of the exemplary support is a double pointed anchor 602, many of the same said anchors being placed around the loop (in this version, but not necessarily, at regular intervals). In some embodiments, each anchor is formed from a single loop 602 of cable having a catch (e.g., a barb or fishhook) at opposite free ends 616, 618. Each anchor is resilient and has a relaxed state as shown in fig. 53, with a distance 619 between the two grippers, and the tips of the two grippers are directed generally toward each other. The ring of anchors is placed over the metal ring and pot-captured (potted) in the molded silicone ring.

After assembly, the support is stretched to a larger diameter and mounted on an insertion tool, not shown. The stretching has two effects. One is that the two ends of the metal loop are pulled apart sufficiently to eliminate the overlap, as shown in fig. 51. The ends of the ring are biased so that the tab ends move outwardly relative to the slot ends. Thus, the tab is positioned to engage the slot when the two ends are once again brought into overlap upon subsequent ring contraction. The ends of the metal loop are beveled to help achieve this configuration as the loop contracts.

Furthermore, as the silicone ring expands, the cross-sectional diameter of the silicone ring shrinks; because the anchor is captured in the silicone ring in a pot fashion, as the ring expands in length and contracts in diameter, the matrix presses against the ring 610 of the anchor and forces them into a temporary configuration as shown in FIG. 48, in which the distance 619 has been increased and the guide of the tip of the grip has been rotated to generally face the direction of insertion, ready for insertion.

As shown in fig. 52, when the insertion tool is removed from the support, the support diameter shrinks, which reconfigures the loop to the desired shape and size. And the cross-sectional diameter of the silicone ring expands, which allows the anchor to relax (fig. 53), thereby driving the grip to rotate and force the tips toward each other to be securely held to the tissue. As the metal ring contracts, the tabs and slots engage in a ratcheting action that allows the support to contract to its final shape and size while preventing reverse expansion from occurring again.

In some cases, locking of the final diameter of the support as shown in fig. 54 and 55 may be achieved by embedding a mating element in the resilient ring 700. A set of elements 704 may be embedded in one plane of the ring and a corresponding set of mating elements 706 may be embedded in a second plane of the ring. The embedding is done in a manner that allows two different types of mating elements to slide relative to each other when the support is expanded and contracted before and during installation. When the appropriate diameter of the support has been reached, a tool can be used to press down on the silicone ring so that the mating elements occupy the same plane and interlock.

In some examples, two interlocking elements 722 and 724 may be formed at the ends of a resilient metal coil 720 that forms part of the support. Once installed and sized, the support may be locked by pressing down to mate the interlocking elements. In some cases, the support may have a central annular lumen filled with uncured polyurethane and positioned such that the diameter or shape or both of the support may be adjusted while being inserted. Once the desired diameter or shape or both has been achieved, ultraviolet light, which may be delivered through a delivery tool or otherwise, may be used to cure and harden the polyurethane. The current cured materials and irradiation may achieve curing in about 20-30 seconds.

FIGS. 32-35 illustrate another exemplary configuration that allows for a reversible procedure for deploying and removing a grip from the annulus tissue to facilitate repositioning. Each anchor 470 incorporates a shearing or clamping mechanism having two pointed (but not barbed) grips 472, 474 on opposite free ends of a 0.015 inch nitinol cable loop. To form each anchor, the cable is wound onto a clamp shaped 476 as shown in fig. 32, which is the open configuration of the anchor. The heat is then used to memorize the set open shape. The ring diameter 478 in this example may be about 0.20 inches for mounting on an annular, elastically stretchable support body having a cross-sectional diameter 480 of about 0.25 inches.

When the ring of each anchor opens up to force it onto the larger diameter 480 support body, the configuration of the anchors automatically causes the two pointed free ends to close up to the gripping configuration shown in fig. 33. Prior to installation and before the support has been loaded onto the insertion tool, the support body is in its contracted installation shape as shown in fig. 33, with all the forceps closed. In fig. 34 and 35, the support has been extended to its insertion configuration in which the diameter 482 is larger to fit over an insertion tool 484 (simulated herein). Due to the shape and configuration of the support body (e.g., silicone tube), when the body is expanded, its cross-sectional diameter is reduced, thereby allowing the anchors to relax to their natural open shape, ready for insertion.

Insertion is performed by pushing against the open and appropriately shaped annulus so that the sharp point of the grasping member penetrates the tissue. When the insertion tool is removed from the support, the support body contracts to the final desired shape and diameter of the valve annulus. When it is retracted, the forceps are forced to grasp the tissue of the circumferential band and hold the support firmly in place. In this way, the support is relatively easy to insert and can be removed and repositioned by reversing the process, i.e. by unfolding the support body, releasing the forceps.

Various insertion tools (which we also sometimes refer to as dilators) may be used to attach the support to the heart valve annulus tissue. Some have been described above and some others are discussed below.

An important principle of the configuration and operation of at least some examples of insertion tools is that they enable a physician or catheter operator to reliably and easily install a support in a wide range of patients having heart valves of various physiological conditions and whose heart valves are of various shapes and sizes. In other words, the insertion can be conventionally and simply achieved. This may be accomplished by an insertion tool that automatically and easily temporarily deploys and reconstructs any heart valve annulus to assume a common deployed shape or size or both so that a support that has been pre-deployed to the common shape or size or both may be attached regardless of the patient's unextended condition and configuration of the valve annulus. The support is configured so that after insertion the support can be reconfigured, either automatically or by manipulation, to a final, safe, stable, desired shape and size after removal of the insertion tool.

Fig. 36-39 show an example of an insertion tool 500 that includes a dilator 502 formed from six arms 504 equally spaced about an insertion axis 506. Each arm is formed from a 0.125 "wide strip of spring steel metal bent at two locations 508 and 510. The ends 512 of the arms are brought together and held by a portion of plastic tubing 513 on the end of an aluminum inner tube 514(0.28 "od, 0.24" id). The opposite ends 516 of the arms are brought together and held to an outer aluminum tube 520(0.37 "od, 0.30" id) by a portion of the tube and a shaft bushing 518. The outer tube is connected to a handle 522. The inner tube, which slides along the insertion shaft within the outer tube, is operated by the second handle 524.

By pushing or pulling 526 on the second handle relative to the first handle, the inner tube moves back and forth relative to the outer tube, which causes the arms to inflate as shown in fig. 38, or deflate as shown in fig. 37. A thin molded sleeve 530, such as silicone, protects the mechanism and protects the cardiac tissue and support from damage. The support is stretched and mounted over the dilator at the central spine 532 before the support is mounted in the heart valve. It may be held in place by force and friction, or may be tied by sutures that are cut after installation, or the central spine may be provided with a cavity in which the support is located. Another view of the central spine 532 is shown in fig. 44.

As shown in fig. 42 and 43, in some examples, the dilator may include rounded cable arms 550, the arms 550 being evenly spaced about the insertion axis and each shaped to the deployed configuration shown in fig. 42. The ends 552, 554 of each cable are secured to two circular hubs 556, 558, respectively. The upper hub 556 has a central bore (not shown) that is threaded to receive the threaded rod 560 to which the handle 562 is clamped. The other end 559 of the threaded rod is fixed to the hub 558. The threaded rod may be advanced through the upper hub toward the lower hub or withdrawn from the lower hub away from the upper hub (depending on the direction of rotation) using the handle to rotate 564 the threaded rod. The rod is pushed or pulled over the lower hub, increasing or decreasing the distance 566 between the two hubs and forcing the arms to collapse or allowing them to expand to the shape of the set expanded configuration.

As shown in FIG. 40, in some embodiments, each arm 538 of the insertion tool 540 is formed of a rigid limb 544 that is connected at one end 546 to an outer tube 548 and at the other end 549 to a wider limb 550. The other end 551 of the second limb is connected to the inner tube 554 at a tip 556. The limbs are joined by a hinge element which allows the limbs to pivot relative to each other. On each arm, the clip 560 has a recess to capture the support at one location along its perimeter.

Figure 41 shows the support mounted on the insertion tool ready for insertion. Fig. 58 and 59 show a version 730 of the support. This version 730 has successive rings of hexagonal portions 732, 734 that meet at short edges 736, 738. At the junction of the longer edges 740, 742, 744, 746 of the hexagonal portion are sharp free ends 748, 750 pointing in opposite directions. Further, on each hexagonal section, one sharp free end 750 is longer than the other sharp free end 748 and has barbs 752, 754, 756 for grasping tissue 757, the sharp free ends 750 of the barbs having penetrated the tissue 757. On all of the hexagonal portions 732, 734, all of the barbed sharp free ends 750 point in the same direction 751. The other set of free ends 748 are unbarbed and can further stabilize the struts by piercing other adjacent tissue, if any, to deposit them inside and further secure the struts to the tissue. All other free ends 748 point in the same direction 753, which direction 753 is opposite to direction 751 where barbed sharp free ends 750 point.

This version 730 of the support member is elastic and can be expanded to a delivery configuration and later contracted to a final configuration. As shown in fig. 60A and 61A, as the struts are deployed 760 to a larger diameter 762 in a delivery configuration, such as by a delivery tool, each hexagonal portion 732 increases in width and decreases in height 772. As shown in fig. 60B and 61B, as the supports constrict 764 to a smaller diameter 766 in the final configuration, each hexagonal portion 732 decreases in width 770 and increases in height 772. In some embodiments, this version 730 of the support may be made of a flexible shape memory material, such as nitinol or a biocompatible elastomer (or other material) configured to contract 764 the support to a final configuration upon insertion into tissue. For example, the support may be configured to contract during exposure to human body temperature.

Other embodiments are within the scope of the following claims.

Claims (84)

1. An apparatus, comprising:

a cardiac tissue support having a gripping element,

each of the gripping elements having: a free end sufficiently sharp to penetrate heart tissue when pushed against the tissue; and a feature for resisting withdrawal of the gripping element from the tissue after the sharp free end has penetrated the tissue.

2. The apparatus of claim 1, wherein a free end of the gripping element protrudes away from a surface of the support.

3. The device of claim 1, wherein the feature that resists withdrawal of the gripping element from tissue comprises a finger projecting laterally from the gripping element.

4. The apparatus of claim 1, wherein the cardiac tissue support comprises an annular surface that supports the gripping element.

5. The apparatus of claim 1, wherein the support is expandable and collapsible.

6. The apparatus of claim 5, wherein the support has a configurable natural dimension.

7. The apparatus of claim 6, wherein the cable configures the natural dimension.

8. The apparatus of claim 1, wherein the support comprises at least one of stainless steel, gold, nitinol, or a biocompatible elastomer.

9. The apparatus of claim 1, wherein the support comprises a flower holder (torus).

10. The apparatus of claim 1, wherein the support comprises a helically wound portion.

11. The apparatus of claim 1, wherein portions of the support do not support gripping elements.

12. The apparatus of claim 1, wherein the gripping element is organized in a pattern.

13. The apparatus of claim 12, the form comprising rows.

14. The apparatus of claim 12, wherein the forms include groups in which the gripping elements are relatively densely arranged and groups in which the gripping elements are less densely arranged.

15. The apparatus of claim 12, wherein the form comprises an arc.

16. The apparatus of claim 12, wherein the form comprises a cluster.

17. The apparatus of claim 12, wherein the pattern comprises a random arrangement.

18. The apparatus of claim 1, wherein at least some of the gripping elements comprise at least one of an alloy of platinum, gold, palladium, rhenium, tantalum, tungsten, molybdenum, nickel, cobalt, stainless steel, nitinol, and any combination thereof.

19. The apparatus of claim 1, wherein the gripping elements are of the same size.

20. The apparatus of claim 1, wherein some of the gripping elements are of different sizes.

21. The apparatus of claim 1, wherein at least some of the gripping elements have more than one of the features that resist withdrawal.

22. The apparatus of claim 2, wherein at least some of the gripping elements project perpendicularly from the surface.

23. The apparatus of claim 1, wherein at least some of the gripping elements are curved.

24. The apparatus of claim 1, further comprising a sleeve through which tissue may grow.

25. The apparatus of claim 24, wherein the sleeve comprises polyethylene terephthalate.

26. The apparatus of claim 1, wherein there are between about 15 and one million gripping elements on the support.

27. The apparatus of claim 1, wherein there are between about 100 and about 100,000 gripping elements.

28. The apparatus of claim 1, wherein the gripping element comprises a barbed hook.

29. The apparatus of claim 1, wherein the gripping element comprises an arrow.

30. The apparatus of claim 1, wherein the gripping element comprises a hook.

31. In a method for preparing a composite material by using a chemical reaction,

the method comprises the following steps: the shape of a cardiac valve annulus is modified in a catheter laboratory by orienting the tip of a catheter holding a cardiac tissue support having gripping elements on the valve annulus, applying a radial force from the catheter against the annulus by opening a structure at the tip of the catheter, and forcing the support onto the valve annulus when the structure is opened.

32. In a method for preparing a composite material by using a chemical reaction,

the method comprises the following steps: the shape of the heart valve annulus is modified during a surgical procedure by pushing a heart tissue support with gripping elements onto the valve annulus.

33. In a method for preparing a composite material by using a chemical reaction,

the method comprises the following steps: attaching a support to different sized heart valve annuluses in different patients, the support being deployable in preparation for attachment and allowing contraction to a common relaxed, non-deployed natural dimension when the support is positioned on the annulus, and

reducing the size of at least some of the supports in position to less than a common relaxed, non-deployed, natural size to accommodate different sized heart valve annuluses of different patients.

34. A cardiac tissue support comprising:

a plurality of small grasping members, each having tissue penetrating and retaining features, an

A configuration of the gripping member relative to a given region of cardiac tissue, the support member being attached to the given region by a force such that

(1) The penetrating features of a failed set of graspers will not penetrate the tissue,

(2) the penetrating features of the second set of grippers will successfully penetrate the tissue,

(3) the retention features of a subset of the second set of grippers will not retain the grippers in the tissue, an

(4) The retaining features of the remaining grasping members of the second set will successfully retain the grasping members in the tissue and maintain the support member in the desired configuration on the tissue.

35. A method, comprising: pushing the support onto the area of cardiac tissue such that only a portion of the many small graspers on the support embed themselves in and hold in the tissue, the portion being sufficient to securely attach the support to the cardiac tissue.

36. An apparatus, comprising:

an annular heart valve support that is expandable and collapsible and carries a gripping element configured to pierce heart tissue and to retain the element in the tissue after piercing.

37. A tool for attaching a support to a heart valve annulus, the tool comprising a mechanism for holding the support in a deployed configuration prior to attachment, deploying the heart valve annulus prior to attachment such that the support is attached to the deployed valve annulus in its deployed configuration, and releasing the deployed support to a retracted configuration after attachment.

38. The tool of claim 37 attached to the tip of a catheter.

39. The tool of claim 37, further comprising an inflatable balloon.

40. The tool of claim 39, wherein the bladder functions to position the tool.

41. The tool of claim 37, wherein the mechanism also removes the tool from the heart after attachment.

42. A tool for attaching a support to a heart valve annulus, the tool comprising a structure for deploying the annulus of the heart to a predetermined shape under the control of an operator.

43. The tool of claim 42, wherein the structure has a conical outer surface, at least a portion of the outer surface conforming to the predetermined shape.

44. The tool of claim 42, wherein the structure has an outer surface deployable to the predetermined shape.

45. An apparatus, comprising: a support for living tissue, the support having

A grasping element for attaching living tissue and securely holding the support in place, and

cyclic structure of which

Is coupled to the gripping element and is configured to,

adjusting the support between a first configuration for mounting the support and a second configuration in which the support remains securely positioned after mounting, and

is self-supporting in the first and second configurations.

46. The apparatus of claim 45, wherein the living tissue comprises heart tissue.

47. The apparatus of claim 45, wherein the living tissue comprises a heart valve annulus.

48. The device of claim 45, wherein the gripping element is configured to penetrate tissue during installation and grip tissue after installation.

49. The apparatus of claim 45, wherein the ring-like structure is circular.

50. The apparatus of claim 45, wherein the ring-like structure has elements that move annularly relative to each other to adjust the support between the first configuration and the second configuration.

51. The apparatus of claim 45, wherein the loop is larger when the support is in the first configuration than when the support is in the second configuration.

52. The apparatus of claim 45, wherein the ring structure changes its shape to adjust the support.

53. The device of claim 45, wherein the ring-like structure changes its shape during installation without changing the position of the grasping element relative to the living tissue.

54. The apparatus of claim 45, wherein the ring-like structure includes a first element and a second element, the gripping element being attached to the first element, the second element being slidable relative to the first element when the ring-like structure adjusts the support between the first configuration and the second configuration.

55. The apparatus of claim 54, wherein the first element comprises a resilient annular tube to which the gripping element is attached, and the second element comprises a rigid adjustable member slidable within the tube.

56. The apparatus of claim 54, wherein the second element comprises a self-supporting coil.

57. The apparatus of claim 55, wherein the self-supporting coil comprises a rigid strip of material having two free ends that are movable relative to each other to adjust the support between the first configuration and the second configuration.

58. The apparatus of claim 45, wherein the ring structure includes features defining a spacing of gripping elements coupled to the ring structure.

59. Apparatus as claimed in claim 45, wherein the gripping element is adjustable between a first configuration for mounting the support and a second configuration in which the support is held securely in place after mounting.

60. The apparatus of claim 59, wherein the loop structure and the gripping element are configured such that the gripping element automatically adjusts between the first configuration and the second configuration when the support is adjusted between the first configuration and the second configuration.

61. The apparatus of claim 60, wherein the loop structure includes a cross-sectional area that increases as the support is adjusted between the first configuration and the second configuration, and the gripping element is coupled to the loop structure such that the gripping element is adjusted between the first configuration and the second configuration as the cross-sectional area of the loop structure decreases.

62. The apparatus of claim 59, wherein each gripping element comprises a ring and a piercing element attached to the ring, the orientation of the piercing element changing as the ring changes between the first configuration and the second configuration.

63. The apparatus of claim 45, wherein adjustment of the support between the first configuration and the second configuration is reversible without the grasping element damaging the tissue.

64. The apparatus of claim 45, wherein the loop structure includes a lock that prevents a change in configuration of the support.

65. The apparatus of claim 64, said locking member comprising a pair of cooperating elements.

66. The apparatus of claim 65, wherein one of the engagement elements comprises a tab and the other of the engagement elements comprises a slot.

67. The apparatus of claim 65, wherein one of the mating elements comprises a pin and the other of the mating elements comprises a hole for the pin.

68. The device of claim 64, wherein the ring-like structure has a central axis and comprises two parts which are moved relative to each other around the central axis to a position where the mating elements are mated.

69. An apparatus, comprising:

a grip, comprising: penetrates the tip of the living tissue,

an elastic ring supporting the tips, the elastic ring having a relaxed configuration and a non-relaxed configuration,

the tip has different orientations associated with the relaxed configuration and the non-relaxed configuration, respectively.

70. The device of claim 69, wherein the tip has at least one barb.

71. Apparatus according to claim 69, wherein said grip comprises more than one such tip.

72. The apparatus of claim 69, wherein the resilient support and the guide of the tip have a configuration.

73. The apparatus of claim 69, wherein the grip comprises a cable.

74. The apparatus of claim 69, wherein the ring is circular.

75. The apparatus of claim 69, wherein the grip comprises a strip of material formed from a material.

76. The device of claim 69, wherein there are two such tips facing each other and acting as a forceps in at least one of the relaxed and non-relaxed configurations.

77. A heart valve repair ring, comprising: a circular, self-supporting, elastic ring having a relaxed diameter corresponding to a healthy heart valve and an enlarged diameter to fit an insertion tool,

a grip attached to the resilient ring and guided in a direction that automatically changes between an insertion direction and an installation direction during installation.

78. A method, comprising: forcing pointed grippers on the support to penetrate the tissue of the annulus of the heart valve and securely hold the support on the annulus to modify the shape of the annulus, and

removing at least a portion of the support from the annulus by withdrawing at least some of the pointed grippers without damaging the heart valve annulus.

79. A method, comprising:

installing the deployed elastic support on the cardiac valve annulus,

allowing the support to contract to the diameter of a healthy annulus, an

The contracted support is locked in its contracted diameter by mating elements of the support.

80. A method, comprising: the gripping elements coupled to the heart annulus support ring are positioned in the tissue of the annulus by allowing the support ring to collapse from an expanded size to a smaller size during installation.

81. The apparatus of claim 1, wherein the support comprises annular elements, pairs of which are connected along edges of the elements to form a ring.

82. The apparatus of claim 81, wherein each of the ring elements carries at least one grip.

83. Apparatus as claimed in claim 82 in which each annular element also carries a pointed element aligned in the opposite direction to the grip.

84. The apparatus of claim 81, wherein each ring element comprises a hexagon.