JP2012521222A - Reconstruction of cardiac features - Google Patents

Abstract

In particular, the heart tissue support has a gripping element, each element being free from the tissue after the sharp free end has penetrated the tissue, and a free end that is sharp enough to enter the tissue when pressed against the heart tissue. And a feature that resists drawers. In particular, the distal end of the catheter holding the heart tissue support with the grasping element is oriented to the annulus and the structure is opened by applying a radial force from the catheter to the annulus by opening the structure at the distal end of the catheter. During this time, the shape of the heart annulus is corrected in the catheterization chamber by pushing the support onto the annulus. In particular, the shape of the heart annulus is corrected during the surgical procedure by pressing a heart tissue support having a grasping element onto the annulus.

Description

  This application is a continuation-in-part of U.S. Patent Application No. 12 / 407,656 filed on March 19, 2009, which is a continuation-in-part of U.S. Patent Application No. 11 / 620,955 filed on January 8, 2007 This is a continuation-in-part of US patent application Ser. No. 12 / 563,293, filed Sep. 21, 2009, and claims the benefit of its priority, all of which are hereby incorporated by reference in their entirety.

  This specification relates to reconstruction of cardiac features.

  For example, a heart valve annulus (fibrous ring attached to the heart wall) maintains the shape of the valve opening and supports the valve leaflets. In a healthy heart, the annulus is typically circular and has a diameter that allows the leaflets to tightly close the valve, which ensures that no blood reflux occurs during heart contraction. Become. For example, the size and shape of the annulus can distort over time due to the fact that the annulus of the tricuspid valve is more stably supported by the heart tissue on the other side than the one side of the annulus, and for other reasons . Strain can cause blood to flow backwards through the valve, preventing it from closing properly. For example, during a thoracotomy, a ring or other support can be attached around the annulus to correct the distortion and restore its shape and size.

Overview In general, in one aspect, a cardiac tissue support has grasping elements, each grasping element having a free end sharp enough to penetrate the tissue when pressed against the heart tissue, and a sharp free end on the tissue. And a feature that resists withdrawal of the grasping element from the tissue after intrusion.

  Embodiments can include one or more of the following features. The free end of the gripping element can protrude away from the surface of the support. Features that resist withdrawal of the grasping element from the tissue may include fingers that project laterally from the grasping element. The cardiac tissue support can include an annular surface having a grasping element. The support can be expandable and contractible. The support can have a settable inherent size. The wire may set a unique size. The support may comprise at least one of stainless steel, gold, nitinol or a biocompatible elastomer. The support can include a torus. The support can include a spirally wound portion. Some parts of the support may not have gripping elements. The gripping elements may be organized as a pattern. The pattern can include columns. The pattern may include a group in which the gripping elements are arranged at a higher density and a group in which the gripping elements are arranged at a lower density. The pattern can include an arc. The pattern can include clusters. The pattern can include a random arrangement. At least some of the gripping elements can include at least one of platinum, gold, palladium, rhenium, tantalum, tungsten, molybdenum, nickel, cobalt, stainless steel, nitinol, and alloys of any combination thereof. The gripping elements can have the same size. Some of the gripping elements can have different sizes. At least some of the gripping elements may have more than one feature that resists withdrawal. At least some of the gripping elements can protrude orthogonally from the surface. At least some of the gripping elements can be curved. The cardiac tissue support can further include a sleeve through which the tissue can grow. The sleeve can include polyethylene terephthalate. About 15 to 1 million gripping elements can be present on the support. There can be about 100 to about 100,000 gripping elements. The gripping element can include a bar hook. The gripping element can include a sagittal body. The gripping element can include a hook.

  The support may include ring elements, and pairs of ring elements are connected along the edges of the elements to form a ring. Each annular element may have at least one of the grippers. Each of the annular elements may further have a pointed element that faces away from the gripper. Each of the annular elements may include a hexagon.

  In general, in one aspect, correcting the shape of the heart annulus in the catheterization laboratory is to orient the tip of the catheter holding the heart tissue support with the grasping element to the annulus and open the structure at the tip of the catheter This is done by applying a radial force from the catheter to the annulus and pushing the support onto the annulus while the structure is open.

  In general, in one aspect, correcting the shape of the heart annulus during a surgical procedure is performed by pressing a heart tissue support having a grasping element onto the annulus.

In general, in one aspect, the method can expand a support that is expandable in preparation for attachment, and retracts a support that is retractable to a normal, relaxed, unexpanded native size when in position on a different annulus. Attach to different sized heart valve annulus, and reduce the size of at least some of the in-situ supports to be smaller than the normal relaxed non-expanded native size Receiving a heart valve annulus.

  In general, in one aspect, a cardiac tissue support includes a number of small grips each having tissue invasion and retention features, the gripper being configured for a given area of heart tissue to which the support is to be attached by force. The configuration is such that the intrusion feature of the failed set of gripping bodies fails to invade the tissue, the intrusion feature of the second set of gripping bodies successfully invades the tissue, and the second set of gripping bodies A subset of the retention features of the second set fail to retain the gripper in the tissue, and the second set of remaining gripper retention features retain the gripper in the tissue and on the tissue in the intended configuration. It is a configuration that succeeds in maintaining the support.

  In general, in one aspect, a method is for pressing a support onto a region of heart tissue to form part of a number of small grips on the support to securely attach the support to the heart tissue. Embedding and retaining only a sufficient portion within the tissue.

  In general, in one aspect, an annular heart valve support is expandable and contractible and has a grasping element configured to penetrate the heart tissue and hold the element in the tissue after entry. Has been.

  In general, in one aspect, an instrument for attaching a support to a heart valve annulus retains the support in an expanded configuration prior to installation, expands the heart valve annulus prior to installation, and places the support on the expanded annulus in its expanded configuration. Includes a mechanism that allows attachment and relaxes the expanded support after attachment to a contracted configuration.

  Embodiments can include one or more of the following features. The instrument can be attached to the end of the catheter. The device may further include an inflatable balloon. The balloon can serve to position the instrument. The mechanism can also be a mechanism that removes the instrument from the heart after attachment.

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

  Embodiments can include one or more of the following features. The instrument structure can have a conical outer surface, at least a portion of the outer surface conforming to a predetermined shape. The structure of the device may have an outer surface that is expandable to a predetermined shape.

  In general, in one aspect, a support for living tissue includes a gripping element that adheres to the living tissue and holds the support firmly in place. The ring-shaped structure is coupled to the gripping element. The annular structure adjusts the support between a first configuration for installing the support and a second configuration in which the support is securely held in place after installation. The annular structure is self-supporting in the first and second configurations.

  Embodiments can include one or more of the following features. Living tissue includes heart tissue, such as a heart valve annulus. The gripping element is configured to invade the tissue during installation and grip the tissue after installation. The ring-shaped structure is circular. The ring-shaped structure has an element that adjusts the support body between the first configuration and the second configuration by moving in a ring shape with respect to each other. The ring-shaped structure is larger when the support has the first configuration than when the support has the second configuration. The ring-shaped structure adjusts the support by changing its shape. The ring-shaped structure changes its shape during installation without changing the location of the grasping element relative to the living tissue.

  The ring-shaped structure includes a first element to which the gripping element is attached and a first element that is slidable relative to the first element when the ring-shaped structure adjusts the support body between the first configuration and the second configuration. Includes two elements. The first element includes a resilient annular tube to which the gripping element is attached, and the second element includes a rigid adjustable piece that is slidable within the tube. The second element includes a free standing coil. The free-standing coil includes a rigid strip material having two free ends that can be moved relative to each other to adjust the support between the first and second configurations. The annular structure includes features that define the spacing of the gripping elements coupled to the annular structure.

  The gripping element is adjustable between a first arrangement for installing the support and a second arrangement in which the support is held firmly in place after installation. The ring-shaped structure and gripping element are automatically adjusted between the first and second arrangement when the support is adjusted between the first and second arrangement. It is configured to be. The annular structure includes a cross-sectional area that increases when the support is adjusted between the first configuration and the second configuration, and the gripping element is coupled to the annular structure, thereby reducing the cross-sectional area of the annular structure. In doing so, the gripping element is adjusted between the first arrangement and the second arrangement.

  Each of the gripping elements includes a loop and a penetrating element attached to the loop, and the orientation of the penetrating element changes as the loop configuration changes between the first and second arrangements. The adjustment of the support between the first configuration and the second configuration is reversible and the grasping element does not damage the tissue.

  The ring-shaped structure includes a lock that prevents a change in the configuration of the support. The lock 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 includes a pin and the other includes a hole for the pin. The ring-shaped structure has a central axis and includes two parts that are movable relative to each other about the central axis toward the position where the mating element fits.

  In general, in one aspect, the gripping body includes a tip that enters a living tissue and an elastic loop that supports the tip. The elastic loop has a relaxed configuration and a non-relaxed configuration. The tip has a different orientation associated with each of a relaxed configuration and a non-relaxed configuration.

  Embodiments can include one or more of the following features. The tip has at least one acicular protrusion. The gripping body includes two or more said tips. Pointed orientation, elastic support with the following configuration

  The gripping body includes a wire. The loop is circular. The gripping body includes a forming strip of material. There are two said tips that face each other and act as pincers 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 elastic ring having a relaxed diameter that corresponds to a healthy heart valve and an enlarged diameter that is compatible with an insertion instrument. The gripping body is attached to the elastic ring and is oriented in a direction that automatically changes between insertion orientation and installation orientation during installation.

  In general, in one aspect, the method corrects the annulus shape by pushing a pointed grip onto the support to penetrate the tissue of the heart annulus and keep the support firmly on the annulus. including. Next, at least some of the support is removed from the annulus by withdrawing at least some of the pointed grips without damaging the heart annulus.

  In general, in one aspect, a method includes mounting an expanded elastic support on a heart annulus, contracting the support to a healthy annulus diameter, and shrinking by fitting elements of the support. Locking the supported support at its contracted diameter.

  In general, in one aspect, the method comprises seating a grasping element coupled to a heart annulus support ring within the annulus tissue by contracting the support ring from an expanded size to a smaller size during installation. including. Advantages of these and other aspects and features include one or more of the following. The operator does not need to work so slowly to accurately attach the heart tissue support to the annulus, and the placement does not require as much accuracy. Not all bar hooks or grippers need to be attached to the annulus to maintain the support in place. Some bar hooks or grippers may fail to grab tissue or be pulled away from tissue by force. Nevertheless, as long as the minimum threshold percentage bar hook or grasping body remains in place, the tissue support also remains in place. Furthermore, this procedure can be performed in the catheterization laboratory and during surgery because of its ease and simplicity.

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

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

1A-1H show the delivery of a heart valve support. 2A-2D are perspective views of a heart valve support. FIG. 2E is a plan view of the recurved hook. It is a cross-sectional side view of a heart valve support. 4A-4C are side and detail views of the delivery device and heart valve support. FIG. 6 is a side view of a delivery device. 6A and 6B are cross-sectional side views of a catheter delivery device. 7A-7B show the delivery of a heart valve support. 8A-8I show the delivery of a heart valve support. 9A, 9R, 9T and 9U are plan views of the heart tissue support. 9B, 9P and 9S are perspective views of a fragment of a heart tissue support. 9C-9E, 9G and 9H are side views of the bar hook. FIG. 9F is a schematic view of a heart tissue support attached to a ring-shaped tissue. 9I-9M and 9O are enlarged views of a portion of the heart tissue support surface. 9N and 9Q are views of a cardiac tissue support and delivery device. 10A and 10B are side views of a delivery device and a cross section of a sheath. 10C and 10D are cross-sectional views of the delivery device and sheath. FIG. 11A is a perspective view of a delivery device within a heart valve annulus. FIG. 11B is a view of the operator end of the delivery device. 11C and 11F are enlarged views of the heart tissue support attached to the delivery device. 11D and 11E are enlarged views of a portion of the heart tissue support attached to the annular tissue. 12A and 12B are views of the core of the delivery device. FIG. 12C is a perspective view of the core of the delivery device. 13A-13D show the delivery of a heart valve support. 14A to 14D are perspective views of a part of the support. It is a perspective view of an anchor. It is a perspective view of a holding body. It is a side view of a holding body. It is a perspective view of a cover. It is a fractured perspective view of a support body. It is a perspective view of a support body. It is a one part enlarged perspective view of a support body. It is a top view of a holding body. It is a top view of a holding body. It is a top view of a holding body. It is a top view of a holding body. It is a top view of a holding body. It is a top view of a holding body. It is a perspective view of a support body. It is a cross-sectional perspective view of a support body. It is a perspective view of a support body. It is a cross-sectional perspective view of a support body. It is a top view of a holding body. FIG. 6 is a top view of a support on a virtual insertion instrument. FIG. 6 is a top view of a support on a virtual insertion instrument. FIG. 6 is a perspective view of a support on a virtual insertion instrument. It is a side view of an insertion instrument. It is a side view of an insertion instrument. It is a side view of an insertion instrument. It is a side view of an insertion instrument. It is a side view of an insertion instrument. It is a perspective view of an insertion instrument. It is a side view of an insertion instrument. It is a side view of an insertion instrument. It is a side view of an insertion instrument. It is a one part perspective view of a support body. It is a one part enlarged perspective view of a support body. It is a perspective view of a support body. It is a perspective view of an anchor. It is a perspective view of a coil. It is a perspective view of an elastic ring. FIG. 6 is a perspective view of a ring and coil assembly. It is a perspective view of a support body. It is a side view of an anchor. It is a perspective view of an occlusion part. It is a side view of an occlusion part. It is a perspective view of an occlusion part. It is a perspective view of an occlusion part. It is a perspective view of a support body. It is a perspective view of a support body. 60A and 60B are views of a portion of the support. 61A and 61B are top views of the support.

As shown in the example of FIGS. 1A to 1G, the distortion of the annulus 18 of the heart valve 16 can be corrected simply and quickly by the following steps.
A. 201 (FIG. 1A) presses the conical headend basket 220 of the delivery device 200 into the valve to create a distorted annulus (203, FIG. 1F) in the desired configuration (e.g., annulus 205, FIG. Match the size (FIG. 1H) larger than the desired final diameter 209 of the annulus (eg, at diameter 207) (the device including the basket is shown in side view and the valve and annulus are shown in cross-sectional side view).
B. Push 201 on the delivery device and continue to expand the heart valve support 100 (which has the desired configuration and larger size and is temporarily kept in that expanded configuration on the device basket) to the annulus By moving toward the perimeter of the annulus, a plurality of (e.g., 8 or more or fewer) recurved hooks 120 located along the periphery of the support Sit simultaneously in the valve tissue at multiple locations (FIG. 1B).
C. After seating the hook, pull the tip 230 of the head end basket from the inside 204 (Figure 1C) and turn it over to roll the support so that the tip 122 of the hook rotates 211 and the annulus more firmly Implanted in tissue (Figure 1C).
D. After further embedding the hook, pull 204 inside the tip 213 of the end of the head-end basket (Figure 1D) and pull the instrument away from the support (Figure 1E) to bring the support to its final size and shape 215. Shrink (FIG. 1H) and leave the support permanently in place to maintain the annulus in the desired final configuration and size.

  In many cases, the entire procedure can be performed in less than a minute. By temporarily expanding the annulus of the valve to the desired ring shape, it becomes possible to push a plurality of grasping elements into the tissue at once and quickly, easily and more or less automatically attach the support. . Although this example uses hooks, other types of gripping elements can be used as well. The physician must attach individual sutures or clips at once along the perimeter of the distorted annulus and then tighten them together to reshape the supported annulus to the desired shape and size, Avoid time-consuming stages. Thus, the physician does not need to be able to see the annulus clearly (or completely). Once attached, the support automatically returns to its final shape and size when the instrument is removed.

  As shown in FIGS. 2A and 2D, in some embodiments, the support includes an annular ring body 110 having hooks 120. The body 110 is (a) from a minimum diameter long-term configuration (FIG. 2A) that matches it after it is attached to the annulus (b) as it is kept on the instrument head-end basket as well as FIG. , 1B and 1C, can be expanded to an expanded delivery configuration (FIG. 2D) that matches while it is attached. The long-term configuration is usually annular and has a healthy annulus diameter for a particular patient. When installed, the support maintains a healthy configuration of the annulus so that the valve works properly.

  In some examples, the body 110 has the same (eg, annular) shape but different diameters in the delivery configuration and the long-term configuration. The body is constructed of a material or manner that deflects the body to contract into a long-term configuration. For example, the whole or part of the body 110 can be formed as a helical spring 110a, such as a continuous helical spring, which is connected at opposite ends to form an annular body or one or more interconnecting helical spring segments. Form (FIG. 2B). In some examples, the support body 110b may be a band of shape memory material, such as nitinol or a biocompatible elastomer (or other material) that expands to a long-term configuration after expanding to a delivery configuration (FIG. 2C).

  The hooks 120 can be as few as 3 or as many as 10 or 20 or more, and they can be arranged at equal or unequal intervals along the body as required. This makes the body easier and faster to deliver, its placement is permanent, and is effective in correcting for annulus distortion. The hooks are constructed and attached together along the outer circumference of the ring so that when the instrument is pulled apart and the basket is turned over, they are simultaneously inserted into the tissue along the periphery of the annulus and then firmly embedded Can do.

  In some examples, one or more parts of the support body are hooked when the annulus segment shares a boundary with sensitive or sensitive tissue, such as the atrioventricular (AV) node of the heart. There may not be. This tissue should not penetrate with a hook. The support body, which is configured to avoid interference with the atrioventricular node, is either covered or protected so that the hook is not attached or otherwise prevents entry into the atrioventricular node. May have some categories. The support body should be positioned so that this special section of the support is adjacent to sensitive or delicate tissue when the support body is in place. The support body may have two or more special sections that lack a hook so that the operator has more than one option when placing the support body near sensitive tissue. In some instances, the support body may have been partially removed and may be more or less like a “C” letter instead of a full ring. In any of these examples, the previously described procedure may have a further step preceding Stage A, in which the operator rotates the delivery head so that the hook is attached to other tissues. At the moment to be implanted, a section without a hook or a gap in the support body is positioned adjacent to the sensitive tissue. The support body may have radiopaque marks that help the operator see the positioning.

  For this reason, for example, as shown in FIG. 2E, each of the hooks has two pointed features. One pointed feature is a sharp free end 122 that faces away from the valve leaflet during delivery. The other pointed feature is a needle-like protrusion 128, which is formed at the bend between the sharp free end 122 and the opposite connecting end 124 where the hook is attached to the body 110, for example welded or glued. The acicular protrusion faces the valve leaflet during delivery. Thus, the needle-like protrusion is arranged to penetrate the tissue when the instrument is pressed against the valve, and the sharp free end is arranged to embed a hook in the tissue when the instrument is pulled away from the valve. The

  Each hook 120 can be formed of 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 hook needles are pushed together (and more or less simultaneously) into the tissue at a series of locations around the circumference of the temporarily expanded annulus. At a later stage, the sharp free end is rotated somewhat away from the leaflets for secure (eg permanent) attachment.

  To rotate the hook during delivery, the hook 120 is permanently attached to the support body 110, as shown, and the support body is rolled 123 around the central ring shaft 112 of the support body (FIG. 3 )be able to. One way to cause the rolling of the support body and the associated rotation of the hook is represented by the central annular shaft 123, much like a rubber o-ring can roll about its central annular axis. The rotation of the entire body about the axis allows the body to change its configuration. The reconfiguration of the body to cause the hook to rotate can also be realized in other ways.

  In some examples, applying an axial force (arrow 113) to the inner periphery of the ring (we may refer to the support broadly as a ring) causes the ring to tend to roll. The hook is embedded in the annulus as intended. By properly mounting the inner periphery of the ring on the outer periphery of the delivery device, the axial force 113 can be applied by pulling the device away from the leaflet of the valve as previously described.

  For delivery to the annulus, the valve support 100 is first expanded to its delivery configuration and temporarily mounted on the delivery head 220 of the instrument 200 (FIG. 4A). The support expands sufficiently in its temporary mounting on the instrument and may be mounted sufficiently far away from the tip along the conical headend basket, thereby allowing the instrument headend basket to be valved. When pushing against the annulus to expand it to the size and shape of the expansion support, the annulus initially reaches the annular undistorted shape, after which the support hook acicular process begins to invade the tissue . The tapered profile of the delivery device head end basket allows the device to accommodate various sized supports. In some embodiments, different shaped and sized baskets may be used for different sized supports.

  The heart valve support 100 is held in place on the delivery head 220 using one or more releasable connections 246. Connection 246 is arranged to transfer force from instrument 200 to support 100 in each of two opposite directions 248 and 250 toward or away from the leaflet of the valve. When the support is embedded in the annulus and the instrument is pulled in direction 250 to release it from the support, the force on the connection 246 exceeds a predetermined threshold and the connection is pulled away, so that at the end of the delivery process the instrument is Released from the support. In some examples, the connection 246 can be a separable suture 252 (FIG. 4A), or some other detachment structure, such as a clip or adhesive, or a structure that can be manipulated from the instrument by screwing or other manipulation. .

  In some examples, connection 246 includes a retainer that can take, for example, the configuration shown as 254a or 254b (FIGS. 4B and 4C, respectively). In the example shown in FIG. 4B, the retention element 254a has one rigid finger 256 that moves the instrument in direction 248 while attaching the support 100 to the instrument 200 and pressing it into the heart tissue. Transfer the force from the instrument to the support. The second deformable finger 258 helps maintain a connection between the support 100 and the instrument as the instrument 200 is moved in the direction 250, and a force in the direction 250 against the embedded support is predetermined. When the threshold is exceeded, it can be deformed to release the valve support 100 from the instrument 200 (dashed line).

  In the example shown in FIG. 4C, the retaining element 254b includes a finger 260 having a curved portion 262 that receives the support 100 and forces the support from the device 200 to the support 200 as the device 200 is moved in the direction 248. Move. The finger has an elastically deformable tip 264, the tip is deflected towards the tapered body 222, which helps to maintain the connection between the support 100 and the instrument 200, It can also be deformed to move the instrument in the second axial direction 250 relative to the embedded support and release the valve support 100 from the instrument 200 when the force exceeds a predetermined threshold (hidden line). As shown).

  As shown in FIG. 5, in one example of an instrument 200 that can be used to deliver a support during a thoracotomy, a basket 220 has a long end with a handle 212 at the operator end 214 at its wide end. Connect to a set of stiff wires or other rigid protrusions 216 that fan out from 210. Thus, the protrusions 216 connect the shaft 210 to the basket 220 and transfer the pulling or pushing force between the shaft and the basket (and subsequently to the support).

  The basket example shown in FIG. 5 includes a tapered body 222, which has a network of interconnected struts 224, the mesh comprising an array of openings 226 that together form a tapered semi-rigid net. Stipulate. In this example, the basket (which may be referred to as the delivery head) 220 has a circular tip 228. The head 222 tapers radially outward along the longitudinal axis 234 of the head 220 according to the distance from the tip 228 to the operator. The wide end 232 of the tapered body 222 is rigidly attached to the protrusion 216, which tapers in the opposite direction from the basket taper. The net formed by the struts 224 is stiff enough to allow the operator to push the valve support against the heart tissue to allow the needle hooks of the support to penetrate the tissue. Is semi-rigid in the sense that it has sufficient flexibility to allow the headend basket to be turned over when pulling on the handle to flip the basket and release the support from the basket.

  In some embodiments, the stem 210 defines a lumen 236 that extends between the heart valve end 218 of the stem 210 and the handle 212. The wire 238 is arranged to freely move back and forth within the lumen 236. The wire 238 has one end 240 extending from the handle 212 and an opposite end 242 connected to the inside of the tip 228. By pulling on the wire 238 (arrow 244), the delivery head 220 can be folded (hidden line) and flipped radially inward starting at the tip 228 as previously mentioned.

  Returning to the more detailed discussion of FIGS. 1A-1E, the operator presses the tapered end 230 of the head basket 220 into the valve 16 (e.g., a tricuspid valve) to widen the leaflet 14 and thereby expand the support. Start delivery. The tip 230 is small and circular, which makes it relatively easy to insert it into the valve without the need for very precise guidance. Since the head end basket is tapered, the operator can keep pushing to expand the annulus 18 of the tricuspid valve 16 in size and match the desired shape, typically an annulus. . During insertion, the head-end basket tends to be self-centering because of its symmetrical taper. The taper of the basket 220 translates the insertion force in direction 248 into a radial force that causes the annulus 18 to expand and temporarily assume the desired shape (and a diameter larger than the final diameter).

  As the operator continues to push the instrument, the hook-like ring of the hook touches the heart tissue along the ring of insertion site defined by the outer circumference of the annulus and then enters (penetrates), sharp free of the hook The end enters and sits in the tissue in much the same way as a fishhook. Depending on how the operator guides the instrument, the basket can be oriented during insertion so that substantially all hooks enter the tissue simultaneously. Alternatively, the instrument delivery angle may be varied to tilt the instrument during insertion so that the hook on one side of the support first enters the tissue, and then sequentially push the other hooks into the tissue. There is sex.

  In general, if the number of hooks is relatively small (e.g., 6-20, comparable to the number of sutures that doctors use for conventional suturing of the ring on the annulus), all hooks will enter the tissue and It is desirable to ensure proper seating.

  Once the hook is embedded in the tissue, the operator pulls the proximal end 240 of the wire 238 to fold the basket 220, flip it over and pull it out of the valve 16. Eventually, the inverted part of the basket reaches the valve support 100. By further pulling, the operator rolls the body 110 of the support 100 around its central axis (similar to the o-ring example mentioned above), which causes the hook 120 to move to the valve 16 annulus. It is more firmly embedded in 18 tissues.

  Using final traction, the operator disconnects the connection between instrument 200 and valve support 100 and removes instrument 200, leaving valve support 100 in place. When the basket 220 being turned over passes through the connection point 246, the holding force acting in the direction 248 in which the embedded hook 120 of the support body 110 exercises is applied to the support body 110 (through the connection 246). ) Exceeding the force acting in the exercising direction 250, this causes the connection 246 to be pulled or released, followed by the release of the support 100.

  The instrument 200 is then withdrawn, causing the valve support 100 to contract with the annulus 18 to a long-term configuration.

  In an embodiment useful for transdermal delivery of a support, as shown in FIG. 6A, delivery head 220a can be made, for example, from a shape memory alloy, such as Nitinol, so that body 222a can be percutaneous inlet (eg, femoral vein). ) And radially folded toward the longitudinal axis 234a before and during delivery of the head into the heart. Delivery head 220a deflects toward the expanded tapered configuration shown in FIG. 6A. Thus, the delivery head 220a in the form of a tapered semi-rigid net opens through the protrusion 216a that opens out radially from the catheter shaft 210a and tapers in a direction opposite the taper of the delivery head 220a. Connected to 210a (here we refer to the delivery head as the headend basket).

  The protrusion 216a is elastically attached to the catheter shaft 210a and deflects toward an expanded tapered orientation, for example as shown by the protrusion 216b shown in FIG. 6B deflected by a spring. The protrusion 216a includes a spring 278, such as a torsion spring (shown), that is attached to the catheter shaft 210a and forms an elastic connection.

  Wire 238a slides within lumen 236a of shaft 210a in a manner similar to that previously described.

  Instrument 200a also includes a sheath 280 that allows catheter shaft 210a to slide during placement of the support. Because the sheath 280, catheter shaft 210a and wire 238a are all flexible along their length, the instrument 200a is refracted and bent along the blood vessel to reach the heart and delivery head within the heart. Enables one-time operation.

  To transdermally deliver the support as shown in FIG. 7A, when preparing the delivery head for use, the sheath 280 is retracted beyond the protrusion 216a to expand the delivery head 220a. The valve support 100 is then expanded to the delivery configuration (by hand or using an expansion device) and attached to the tapered body 222a. The valve support 100 is connected to the delivery head 220a using a releasable connection, such as a separable suturing and / or retaining element (as described above).

  Next, as shown in FIG. 7B, the sheath 280 is moved along the catheter shaft 210a toward the delivery head 220, causing the protrusion 216a and the delivery head 220a to contract radially inward to fit within the sheath 280. Let In the contracted configuration, the tip 228a of the delivery head 220a is opposed to the end 282 of the sheath 280. The circular tip 228a can provide, for example, easier delivery and maneuverability in guiding the blood vessel to reach the heart.

  To deliver the support to the annulus, the end 230 of the instrument 200a is percutaneously sent through the blood vessel to the right atrium 24 (FIG. 8A). Next, as shown in FIG. 8A, the sheath 280 is retracted to expose the valve support 100 and expand the protrusion 216a, delivery head 220a and support 100.

  In a stage somewhat similar to the thoracotomy of the support, the catheter shaft 210a is then advanced along the axis 30 of the annulus 18 in the direction 248a, for example under image guidance. The operator pushes the distal end 230a of the self-aligning delivery head 220a into the valve 16 using sensory or image guidance without actually looking at the valve 16 (FIG. 8B).

  When the tip is in the valve 16, the operator pushes the instrument 214 further into the valve 16 by pushing the end 214a of the catheter shaft 210a. This causes the tapered body 222a of the delivery head 220a to restore the shape of the annulus 18 to an annulus or other desired shape (such as the “D” shape typical of a healthy mitral valve). The instrument 200a tends to be self-aligning because of its shape. The net-like construction of delivery head 220a (and also the head used for thoracotomy) allows blood to flow through the valve even while inserting delivery head 220a.

  As the tool 200a reaches the position where the support hook touches the annulus, as shown in FIG. 8C, the operator should attach the support together with the hook 120 of the valve support 100 by further pushing. Move all the way around the annulus. In some examples, an operator may be able to allow some hooks to enter tissue before other hooks by intentionally tilting the delivery head. The configuration of the valve support 100 and the instrument 200a and the manner of temporary attachment of the support 100 to the instrument 200a ensures that the hook 120 enters the valve 16 at the exact location along the outer edge of the annulus 18 Tend to.

  When the valve support 100 is attached to the valve 16, the operator pulls on the proximal end 240a, which causes the delivery head 220a to be flipped (hidden dashed line) and pulled out of the valve 16 (shown in FIG. 8D). Eventually, the inverted part of the instrument 200a reaches the valve support 100. By further pulling, the operator rolls the torus of the support 100 around its periphery, so that the free end of the hook 120 is pushed firmly into the annulus 18 of the valve 16 as shown in FIG. This allows the support to be permanently seated and allows subsequent growth of tissue around the support 100. The depth and radial extent of each of the deployed hooks 120 can be essentially the same as conventional sutures, so their placement is as effective as conventional sutures and It seems likely to be familiar to the operator and others.

  Using final traction, the operator pulls the connection 246 between the instrument 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 annulus 18 and the wire is advanced in the first direction so that the delivery head 220a assumes its original tapered shape (FIG. 8F). The catheter shaft 210a is then retracted into the sheath 280 (FIG. 8G) and the instrument 200a is withdrawn.

  In some examples, as shown in FIGS. 8H and 8I, the tip 228a of the instrument 200a has a smaller compression dimension than the inner diameter 284 of the sheath 280 when turned upside down, thereby causing the catheter as shown in FIG. 8I. The stem 210a is retracted directly into the sheath 280 after deployment and the inverted tip is kept in the folded delivery basket.

  With the instrument 200a pulled out, the valve support 100 contracts, causing the annulus 18 to reshape so that the valve leaflets 14 coalesce to prevent backflow of blood during the systole.

  Other embodiments are within the scope of the claims.

  For example, distortion of either the tricuspid valve or the mitral valve can be corrected. In the case of tricuspid valve repair, hooks can be placed only about three quarters of the support, ie around the annulus. During the placement procedure, the operator rotates the support to position the portion of the support that has the hook. In mitral valve repair, the hook can cover the entire circumference of the annulus. In this scenario, the hooks are arranged around the entire circumference of the support. Alternatively, the hook can only cover the posterior section of the mitral valve annulus. In this scenario, the hooks can be placed around two-thirds of the support. Similar to the tricuspid valve example, the operator positions the portion of the support with hooks relative to the posterior segment of the mitral annulus. Further, in mitral valve repair, a backup valve can be provided as part of the delivery device to maintain cardiac function during the delivery procedure. Materials other than shape memory materials can be used as the support body material, and other methods are used to return the support to the desired size after expansion, including, for example, a crossbar that spans the opening in the support. be able to.

  In addition, the left atrial appendage of the heart can be closed with similar techniques. For example, by pressing the instrument into the opening of the atrial appendage, the opening can take a predetermined shape. The instrument can continue to be pushed to embed the expanded support hook into the periphery of the atrial appendage opening. The instrument can then be withdrawn to release the support and allow the support to contract. The support can have a relatively small contraction diameter so that upon withdrawal of the device and release of the support, the support can contract to a relatively small size and effectively close the atrial appendage.

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

  The head end of the instrument need not be a basket and can take any form, mechanical arrangement, and strength that allows the annulus to open into a shape corresponding to the shape of the support. The basket can be made of various materials. Use a wide variety of structural mechanisms to both seat and embed the support within the annulus tissue and to allow the support to be pulled and pulled to disconnect the support from the instrument, to keep the basket and Can be pressed.

  The instrument need not be conical.

  The support can take a wide variety of configurations, sizes and shapes and be made of a wide variety of materials.

  There is a possibility of replacing the hook with other devices that use the pushing force of the instrument to seat and embed the support.

  The support hook need not be embedded directly in the annulus, 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 can be a torus in the form of a helical spring (described above). Such a support body may have a natural diameter 116 on the order of 10 centimeters and a proportional natural diameter 114 in its contracted state. The circumference can be selected based on the physical requirements of the particular patient.

  FIG. 9B, which is an enlarged view of a fragment of this support body, shows that some embodiments have several (e.g., many or very many, e.g., only, e.g., 15) Or 100 and up to several hundred or even thousands). In the example shown in FIG. 9B, the helical support body is wound from a flat strip having an outer surface 111 and an inner surface 117. Although FIG. 9B shows a bar hook attached only to the outer surface, the bar hook may be attached to the inner surface for manufacturing reasons or for other purposes.

  Small bar hooks relative to the body are each configured to partially or fully penetrate the annular tissue when a portion of the body to which the bar hook is attached is pressed against the tissue.

  As shown in FIG. 9C, in some examples, each bar hook 120a has a sharp free end 122a for penetrating tissue and at least one acicular protrusion end 128a for maintaining the bar hook embedded in the tissue. , 128b (two shown in FIG. 9C). Each bar hook also has an end 124a attached to the surface of the support body. When the support (we may refer to the support structure simply as the support) contacts the heart tissue, the implanted bar hook keeps the body in the proper position and configuration on the annulus. Bar hooks can be attached to the surface of the support body using glue, cement or other types of adhesive, or the support as part of an industrial process such as molding, etching, stamping, welding or other processes It can be formed from a body or can be attached by a combination of these techniques. Different bar hooks can be mounted on a given support by different mechanisms.

  Each bar hook 120a can be structured and attached so that the free end 122a is oriented in a direction 122b perpendicular to the body surface 111 (or some other selected effective direction or intentionally random direction). In some cases, the bar hook may be curved. The acicular protrusion end 128a may be located on the concave edge 113 (FIG. 9D) or the convex edge 115 (FIG. 9E) of the curved bar hook.

  Bar hooks are similar to bar hooks on the acicular protrusions of natural plants. Different types of attachment devices can be used, similar to a metal-pointed hunting arrow, where the sharp tip has two wide and sharp shoulders, and the shoulder cuts tissue as the tip enters. There is sex. The tips of the two shoulders perform the same function as the needle-like projections, so that the arrow remains embedded when it enters the tissue.

  In some embodiments, the bar hooks on the support body have two or more (sometimes many) different shapes, sizes, orientations, materials and configurations. By varying these features, such as the orientation of the bar hooks, it may be more likely that at least some of the bar hooks will be implanted in the tissue no matter how oriented the support body contacts the annulus. By varying the number, orientation and curvature of the hooks, the possibility of the support body remaining in place can be increased. For example, in such a support, a force applied to the support body in a particular direction may unseat or partially unseat some of the bar hooks by separating the acicular protrusion from the tissue. However, the same force may not affect other bar hooks that have needle-like protrusions oriented in the same or different direction as the unseated bar hooks. Due to the force applied to seat the support, some bar hooks may be more firmly embedded than others.

  In use, typically all of the bar hooks (even in most cases in some cases) are not embedded in the tissue when the support body is pressed against the tissue, or after placement It does not stay. As shown in FIG. 9F, a sufficient number of bar hooks are arranged in an appropriate manner, so one of all hooks is required to create a physical bond and properly maintain the support body in place. Only the part needs to be embedded in the annulus tissue (in some cases only certain areas). The percentage of bar hooks on the support that need to be firmly embedded in the tissue can range from 1% to 10%, or more than 40%. The average spacing of bar hooks that have been successfully embedded is in the range of, for example, one bar hook per millimeter of support body length to one bar hook per 2 or 3 millimeters (or more) to properly secure the support. there is a possibility. If the bar hooks are placed together rather than uniformly disposed on the support, the percentage of hooks successfully embedded and the distance between them may be different.

  When the bar hooks contact the annular tissue during delivery, some of the bar hooks 131, 133 penetrate the tissue but not necessarily all of them (if a retraction force is applied to the delivery device) The acicular protrusion grips the tissue. Of the remaining bar hooks, some 135, 137 may not even contact the tissue (e.g. because of tissue contours), others 139, 141 penetrate the tissue and tissue their needles It may not contact the tissue with sufficient force or proper orientation to seat firmly within. Some of the bar hooks 143, 145 may penetrate the tissue but fail to grasp the tissue. Some of the bar hooks 147, 149 may penetrate the tissue only at the acicular projection end 128a and not with respect to the free end 122a, so that the free end is weaker than the physical bond embedded in the tissue Some physical coupling is provided. However, in some or many or most of the bar hooks that enter the tissue, the needle-like projections 128a are properly seated and resist a force in the direction 151 that unseats the bar hooks differently. Even though the torsional force applied to a particular bar hook in direction 151 may still be large enough to unseat the needle tip, the entire combination of many bar hooks implanted in the tissue There is a tendency to continue to set in place and proper configuration. Over time, some of the bar hooks that were not embedded when the support was placed could become embedded, and some of the bar hooks that were embedded when the support was placed were unseatted May be.

  The resistance to removal of a given bar hook from tissue provided by each of the one or more acicular protrusions may be relatively small. However, a bar hook that has been successfully embedded has a higher cohesive resistance, thus ensuring that the support body is in place and the valve annulus is maintained in the desired shape. In addition, since several (potentially very many) small bar hooks are spread over a relatively large area, the stress on any part of the annulus tissue is quite small, which It helps to keep the support body properly seated and maintain the shape of the valve properly along its entire periphery without being damaged. The fact that a large number of closely spaced bar hooks can be embedded along the length of the support means that the support attaches to the annulus more uniformly and continuously than with the relatively small number of hooks described above. Meaning that it can function better.

  The embodiment shown in FIG. 9A etc. tends to have more and smaller hooks than the embodiment described in FIG. 1A etc., all of which need not be successfully embedded. A common concept between the two deployments is that the hook has a retention element that penetrates when pressed into the tissue and is firmly embedded in the tissue when a pulling force is applied at the end of the deployment process. That's what it means. These two concepts are not mutually exclusive. A support such as the support shown in FIG. 1A may also have a bar hook, and a support such as the support shown in FIG. 9A may also have a hook of the type shown in FIG. 1A. The placement of the support may depend on the combination of both types of hooks.

  Each bar hook can be formed of a biocompatible material such as platinum, gold, palladium, rhenium, tantalum, tungsten, molybdenum, nickel, cobalt, stainless steel, nitinol, and alloys, polymers or other materials. For hooks such as shown in FIG. 1A, the hooks can also be formed of a combination of such materials. Individual support bodies may exhibit bar hooks having a range of compositions. Some of the bar hooks attached to the support body can be composed of one material or combination of materials, and some of the bar hooks can be composed of another material or combination of materials. Each bar hook can be unique in composition. Further, some portions of the bar hook can be composed of one set of materials, and other portions can be composed of another set of materials. In some examples, the bar hook region at the end of the acicular protrusion is composed of one set of materials, alloys, polymers or mixtures and the bar hook region at the free end is composed of another set of materials, alloys, polymers or mixtures. The remainder of the bar hook is composed of a further set of materials, alloys, polymers or mixtures. FIG. 9G shows an exemplary bar hook having only one needle-like projection end 128a. The bar hook extends (in this case) from the mounting end 124a to the free end 122a along the path of the main shaft 920 perpendicular to the support body surface 111. The acicular protrusion end extends a length 904 from the free end 122a of the bar hook to the free end 906 of the acicular protrusion end. This free end 906 forms a sharp tip over an acute angle 910, and the acicular tip 128a is an acute angle 911 that grips the tissue in response to any force that would otherwise pull the embedded bar hook away from the tissue. Over.

  The length 901 of each bar hook measured along the main axis from the mounting end 124a to the free end 122a can be about 1-12 millimeters. Each acicular projection end may extend at a distance 902 from the bar hook that is shorter or longer than the main width or diameter 903 of the bar hook, as measured at the attachment end. The cross section of the bar hook body can be flat or cylindrical or oval or any other shape among a wide variety of shapes.

  Different bar hooks can be placed on the support body surface in different sizes and configurations. For example, different bar hooks can have different lengths and different numbers and arrangements of needle projections. For example, as shown in FIG. 9H, a part of the support body surface 111 is opposed to the bar hook 120a having two needle-like protrusion ends 128a and 128b facing each other in the first direction 950 in the second direction 951. And shorter bar hooks 120b each having one needle-like protruding end 128a. In addition, the bar hooks can be arranged on the surface of the main body with various distribution densities and distribution patterns. For example, as shown in FIG. 9I, bar hooks can be placed on the surface of the body in repeating rows 930. As shown in FIG. 9J, bar hooks can be placed on the surface in rows 931, 932 of different lengths and densities. As shown in FIG. 9K, a bar hook can be placed on the surface along the arc former 933. As shown in FIG. 9L, bar hooks can be placed on the surface as cluster formers 934. As shown in FIG. 9M, the bar hooks can be randomly distributed 935. Other patterns can also be used.

  A single support body can include a wide variety of bar hook patterns on its surface. This is because the physical characteristics of a particular heart valve may mean that the valve tissue is more or less receptive to a particular pattern of bar-hook distribution. Some patterns may be more effective for some types of tissue, and other patterns may be more effective for other types of tissue.

  Further, as shown in FIG. 9N, bar hooks need not be present at the point where the body 110a contacts the delivery device 220, including the area near the rigid fingers 256,258. This tends to prevent the bar hook from sticking the support body to the instrument.

  As shown in FIG. 9O, any two bar hooks can be placed at a distance 905 relative to each other that is longer or shorter than either one of the lengths 901, 901a.

  As shown in FIG. 9P, when the support is formed in a spiral, the ring has a front 961 (facing the valve when the support is delivered) and a rear 960 facing away from the valve. Can be thought of as having In some examples, the support body 110a does not have a bar hook 120a on the rear side 960. In these embodiments of the support body, the back side 960 is covered with a sleeve 963. After attaching the support body to the annulus, the sleeve supports a long-term process of integration with the valve tissue. Over time, the heart tissue adheres to the support body as part of the healing process. The sleeve is made of a material that allows this process to occur faster than without the sleeve. For example, the sleeve can be composed of a porous material that allows the tissue to grow within the sleeve and thus more effectively secure the support to the tissue than without the sleeve. The sleeve material can be a thermoplastic polymer such as Dacron (polyethylene terephthalate). Alternatively, the sleeve material can be metal or another type of material. The sleeve can be disposed on the support body at a location other than the rear side. For example, the sleeve may be placed on the inside 965 of the body and the bar hook may stay on the outside 964.

  The sleeve is formed as a half torus in this example, but may have a wide variety of other configurations. Such a sleeve can be used with any type of support, including the support shown in FIG. 1A etc., and may cover all or only part of the support, such as a hook or acicular hook or There is a possibility of covering a part of the support including both. In the latter case, the hook can be arranged to penetrate the sleeve during set-up and before placing the support in the heart. The sleeve may also cover a portion of the support that is intended to contact delicate or sensitive tissue such as an atrioventricular node. In this case, the sleeve is made of a material that is less likely to damage sensitive or sensitive tissue or interfere with the surgery compared to other materials that can be used for the support.

  By using bar hooks, the attachment of the support can be made faster, simply, reliably and easier than with the larger hooks described above. The delivery device operator may not need to apply as much force as is necessary to embed a larger hook into the annulus. In some cases, it is not necessary to rotate the acicular protrusion as described for the larger hook in order to securely embed the bar hook. The operator does not need to worry about whether all bar hooks are embedded. Once the operator has determined that the support body has contacted the tissue, and by reasoning that many of the bar hooks have been attached, the operator has pulled the support and confirmed that it is seated One of the previously described mechanisms can be used to release the support body from the delivery device. Because of ease of positioning, the procedure can be easily performed in a non-surgical context, such as a catheterization laboratory.

  As shown in FIGS. 13A-13D, in the context of a catheter procedure, for a bar hook support or any other type of support that is deployed, the catheter may include a balloon 228b at the tip of the delivery device. As shown in FIG. 13A, the balloon remains compressed as the catheter passes through the patient's blood vessel and enters the heart. As shown in FIG. 13B, the balloon is inflatable when the tip of the catheter reaches the heart. The inflated balloon floats in the blood that is pumped through the heart and is easily and to some degree automatically (together with the delivery device) towards and into the valve to be repaired. The balloon can continue to move beyond the annulus and, when positioned as shown in FIG. 13C, supports the distal end of the catheter while the operator is supporting the proximal end of the catheter. The catheter shaft then serves as a "rail" that is supported at both ends, along which the operation involving the delivery device and support is generally kept coaxial with the valve. Can be done with confidence.

  In some of the previously described examples, the annulus of the heart valve is expanded to the desired shape by pressing a conical surface, such as a basket, into the heart valve along the axis of the heart valve. Whether delivering in the context of thoracotomy, in a catheterization laboratory, or otherwise, the technique of expanding the annulus after inserting the delivery device into the annulus is confined to the conical surface of the annulus. Can be supplemented or replaced.

  FIG. 9A shows the intrinsic (long-term configuration) diameter 114, which is one diameter of the support body. Recall that this diameter is different from the diameter of the delivery configuration. As shown in FIG. 9Q, the former diameter 114 is smaller than the latter diameter 202 of the delivery device at the support body attachment point 247. As the support body is placed on the delivery head 220, the helical spring coil extends outward as the body expands to fit the instrument.

  During delivery as shown in FIGS. 13A-13D, when the support body is attached to the annulus 18, the operator releases the support from the delivery device. FIG. 13D shows that if there is no outward force already applied by the delivery device, the coil of the helical spring contracts inward 1308, thereby returning the support body to a final diameter 1309 that is approximately its intrinsic diameter. It shows that. Referring again to FIG. 1H, since the annulus is attached to the support body, the support body also pulls the annulus inward to reshape the annulus to the desired smaller diameter 209. I want to recall.

  If the support body is made of a suitably plastic material or alloy, the support body may not fully shrink to its original natural diameter. However, when the support body is made of a shape memory alloy such as Nitinol, the alloy's memory effect tends to shrink the support body to approximately the same or the same diameter as its original diameter.

  As shown in FIG. 9R, the support body 110a may have other portions that do not have a bar hook. As mentioned above, sensitive or sensitive tissue such as atrioventricular nodules should not be punctured or attached to the hook. In some examples, the support body 110a may have a coupling section 972 with a bar hook and an uncoupled section 974 without a bar hook. A non-bonded section 974 that is long enough to abut the atrioventricular node spans an angle 975 of about 40-60 degrees around the circumference of the support body. The coupling section 972 spans the remaining circumference angle 973. In some examples, the unbonded section 974 is covered with a sleeve made of a material suitable for contacting the atrioventricular node or other sensitive tissue.

  As shown in FIG. 9S, the two sections 972, 974 may have radiopaque markers 976, 977 indicating the boundary between the two sections. Markers 976 and 977 are each in the shape of an arrow pointing to the uncoupled section. During delivery, the operator uses radiopaque markers 976, 977 to view the boundaries of the unbound segment 974 and position the unbound segment 974 relative to the atrioventricular node or other sensitive tissue be able to.

  As shown in FIG. 9T, the support body 110a may have a plurality of sections 974, 978 without bar hooks. In some situations, the operator may be limited as to the angle at which the delivery head can rotate. In this example, the operator has multiple options for positioning the support body to avoid puncture of the atrioventricular node, and the operator can deliver the delivery head beyond about 90 degrees in any direction. There is no need to rotate the. Although two unbonded sections are shown, the support body may have more than two of these sections. Non-bonded sections 974, 978 span an angle 975, 979 of about 40-60 degrees of the total circumference. In the example of two uncoupled sections, there are also two coupled sections 980, 982 spanning the remaining two length angles 981, 983 of the circumference.

  As shown in FIG. 9U, the feature of the support body 110a to be in contact with the atrioventricular node may take the form of an open section 990. With respect to the uncoupled sections described above, the open section 990 can span an annulus approximately 40-60 degrees angle 995 defined by the support body 110a, while the support body spans the remaining angle 993. Open section 990 has radiopaque markers on the open ends 992, 994 of support body 110a to assist the operator in positioning open section 990 relative to atrioventricular nodules or other sensitive tissue. May be.

  As illustrated in FIGS. 10A-10D, the delivery head 220 may include a sheath 280a for covering the support body during insertion. 10A and 10B show the sheath in cross-sectional view, and FIGS. 10C-10D show the sheath and delivery head in the AA cross-sectional view of FIG. 10B. The sheath 280a wraps around the delivery head 220 including the support body 110a so that the bar hook does not accidentally puncture or attach to any other tissue or device before reaching the annulus. The sheath is made of a flexible material such as rubber, silicone rubber, latex, or another biocompatible material or material combination. The sheath can also be made of the same material or materials as the catheter. Recall that one embodiment of a sheath is shown in FIGS. 6A-6B and described in the corresponding text. Other embodiments of the sheath are possible.

  For example, the embodiment of the sheath 280a shown in the cross-sectional view of FIG. 10A is maintained in place by attachment to the resilient retaining ring 1000 and crossbar 1010, where the retaining ring and crossbar are perpendicular to the longitudinal axis 234. It is permanently fixed through the shaft 210 and extends outward from the catheter shaft. 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 closer to the distal end than the support body. This sheath 280a is permanently attached 1002 to the retaining ring 1000. The sheath 280a is temporarily attached to the crossbar in holes 1030 and 1032 (visible in FIG. 10B) that are sized to fit the protruding tips 1020 and 1022 of the crossbar 1010.

  As shown in FIGS. 10B-10D, when the delivery head 220 is expanded after insertion of the catheter into the valve and in preparation for attachment of the support body 110a, the retaining ring and crossbar combination allows the sheath to be removed from the crossbar. Disconnect automatically and retract upward from the support body as part of the expansion procedure. The process by which this occurs is as follows.

  Referring to FIG. 10B, as the delivery head expands outward 1006, the delivery head diameter 1008 at the initial point 1012 of the retaining ring attachment increases to a diameter larger than the diameter 1009 of the retaining ring 1000. As a result, the retaining ring rolls 1004 upward from point 1012 to point 1005 on the smaller diameter delivery head. As the retaining ring rolls, 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 110a. A portion of the sheath 280a wraps around the ring as part of the rolling process. In a sense, the retaining ring "rolls up" the sheath in the manner of a scroll that wraps around the roller. The retaining ring 1000 is a rubber or another biocompatible material that is sufficiently resilient to allow the ring to roll upward on the expanding delivery head.

  As delivery head 220 expands, sheath 280a is also released from the crossbar. A cross-sectional view of the delivery head 220 including the crossbar 1010 is shown in FIG. 10C. When the delivery device is moving to the heart valve, the delivery head 220 is in a collapsed configuration. The sheath 280a has holes 1030, 1032 that are configured to pass the crossbar 1010 to keep the distal end of the sheath in the crossbar. Because the crossbar protrudes beyond the sheath, the crossbar ends 1020, 1022 cause the crossbar to puncture or tear any tissue that the crossbar contacts before the delivery head reaches its target. To prevent this, it is circular and smooth. When the delivery head is positioned near or inside the heart valve and begins to expand 1006 outward from the stem 210, the delivery head presses the sheath 280a outward.

  As shown in FIG. 10D, during the expansion process, the crossbar is permanently attached to the shank 210, so the crossbar stays in place and can either extend outward or change configuration. Absent. As a result, the delivery head releases the sheath from the crossbar by pushing the sheath over the crossbar tips 1020, 1022. Thus, the sheath is free to move as the retaining ring rolls upward along the delivery head as previously described. The crossbar 1010 can be made of any of the materials used in the delivery device, or another biocompatible material, which is sufficient to allow the crossbar to maintain the sheath 280a in place as described. It is assumed that it is rigid.

  FIG. 11A shows another version of delivery head 220b. This version is slightly different from the delivery head version already shown. Specifically, in this version 220b, the rigid protrusion 216b is composed of an outer sleeve 1140 that surrounds the inner arm 1142 attached to the shaft 210b by a hinge 1144. When this version of the delivery head expands, the sleeve 1140 extends from the inner portion 1142, and when the delivery head contracts, the sleeve is withdrawn along the length of the inner arm. This version of the delivery head is used in FIG. 11A to demonstrate the use of a clamping wire 1100, although this clamping wire can also be used with other versions of the delivery head.

  As shown in FIG. 11B, this clamping wire 1100 is pierced through the hole 1103 at the operator end 214b of the delivery device 200b and then out again. In doing so, the wire traverses the inside of the stem 210b of the delivery device 200b. The end of the outer wire with respect to the operator side end 214b forms a loop 1102 operated by the operator. By using this wire 1100, a mechanism for adjusting the shape of the support body 110a to some extent with the goal of contracting the final diameter 1309 can be activated. An example of the final diameter is shown in FIG. 13B. Referring again to FIG. 11A, at the other end of the delivery device 200b, the wire exits the shaft 210b at a hole 1105 located at a point beyond the delivery head 220b. The wire is guided to the hoops 1120, 1122 and extends down the side of the delivery head 220b. As shown in FIG. 11C, the wires are pierced along the inside of the helical coils 1150, 1152 of the support. At the position 1164 where the wire has completed the circumference of the support body 110a, the wire goes up the side of the delivery head and returns to the shaft.

  FIG. 11C also shows the hoops 1124, 1126, which are positioned on the delivery head strut 224b at regular intervals to keep the wire properly positioned. At a position 1164 where the wire meets itself and back up the side of the delivery head, spools 1130, 1132, 1134, 1136 attached to strut 224b guide the wire and spiral loops 1150, 1152 in the wire exit region. 1160, 1162 to prevent the wire from rubbing against. The end of the wire that re-enters the hole 1105 (Figure 11A) continues back up the shaft alongside itself, exits the delivery device (Figure 11B), and forms a loop 1102 by connection to another end. To do.

  When the support body 110a is firmly seated on the heart valve annulus 18 (e.g. in the scenario shown in FIG.13C), the operator can reduce the final diameter of the support by pulling the loop 1102 (FIG.11B). it can. When pulled, the wire is tightened, which causes the support coils 1150, 1152 to become more tight 1106, as shown in FIG. 11C.

  When the bar hook of the support is embedded in the annular tissue, the adjusted circumference becomes permanent. Some bar hooks are already embedded, but the tightening procedure pulls some of those bar hooks and other bar hooks into the tissue. This “bundles” the ring-like tissue more closely. FIG. 11D shows an example of a part of the support body 110a attached to the periphery 121 of the annulus after the support body is tightened. As shown in FIG. 11E, after clamping, the support body 110a pulls the tissue more tightly at the periphery 121. Because of this bundling effect, the final diameter of the annulus is slightly smaller. Upon removal of the delivery head, the support body, and thus the attached annulus, contracts to the desired size.

  Referring to FIG. 11F, in order to disconnect the wire from the support body 110a, the delivery head 220b has a blade 1170, which is in one of two rigid fingers 256b, 258b that maintain the support body in place. It is attached. When the rigid fingers 256b are withdrawn from the support body after the support body 110a is in place, the cutting segment 1172 of the blade structure cuts the wire. The operator can pull the outer loop after the wire has been cut off to prevent the drifting end of the wire from moving freely outside the delivery device when the device is being removed from the annulus.

  As shown in FIGS. 12A-12C, a delivery device 200b used in the context of a catheter procedure (but not only) includes a shank 210b, a collapsible conical headend basket 220b, a set of struts 224b, and an operation It shares common elements with the delivery tool discussed above, including the person end 214b. This delivery device 200b is similar to being able to open an umbrella, in which an operator collapses a collapsible conical headend basket 220b from a folded (closed) configuration (shown in FIG. Allows expansion or contraction in the radial direction (shown in 12B). As shown in FIG. 12C, for this purpose, the basket may include a set of spar 1210, 1212, 1214, 1216, 1218 disposed about an axis. Referring again to FIG. 12B, each spar has one hinge end 1220, 1222, which is connected to a central collar 1200 that can be raised 1202 and lowered 1204 along the central axis 1250 of the basket. When the collar 1200 is moved back and forth along the shaft 1250 by the user operating the opening / closing mechanism 1208, the spar 1210, 1220 opens or closes the basket similar to the umbrella mechanism 1206, so that other The hinge ends 1230 and 1232 are connected to the post 224b with the basket hinges 1240 and 1242. The operator end 214b of the delivery device has a torsion or sliding control 1150 that allows the operator to control the collar. In FIG. 12B, the control unit is a sliding control unit, and can slide downward, for example. In this way, the annulus can be expanded to the desired shape by a radial force 1206 that is not imposed by moving the entire basket in a linear direction along the valve axis. Instead, after moving the basket in a linear direction along the valve axis to the desired position, the annulus is expanded to the desired shape. A radial force may also be imposed by a combination or sequence of axial movement of the entire basket and lateral expansion of the basket.

  As shown in FIG. 13A, radiopaque measurement marks 1310, 1312 may be placed on the shank or basket at regular intervals (eg, one mark per centimeter) according to standard measurement units. The mark is used to determine the distance that the delivery device has traversed the heart and its location when the basket is inserted into the valve so that the operator can place the basket in a good position along the axis of the valve. It can be possible to arrange.

  Placement of the support from the basket onto the annulus can be done as part of the operation of opening the basket or after opening the basket. In the former case illustrated in FIGS. 13A-13D, the basket is inserted into the valve up to a point where the basket is adjacent to the annulus. Simultaneously with the opening of the basket, the bar hook on the outer periphery of the support is pushed radially into the annulus tissue. In this method of placing the support, the porous sleeve described above and shown in FIG. 9P is positioned on the inner circumference 965 away from the embedded hook.

  In another approach, similar to the process shown in FIGS. 1A-1D, the basket is inserted into the valve so that the support on the basket is positioned slightly upstream of the location of the annulus. The basket is then opened to bring the annulus to the desired shape, followed by a slight push on the instrument and basket to place the support in place and embed the hook.

  In either approach, when the support is placed, the basket is at least partially closed to release the basket from the support and the instrument is withdrawn from the valve.

  Further, in some embodiments, a combination of these approaches may be used. For example, the basket may be partially opened and fully opened after being inserted into the annulus.

The approach of FIGS. 13A-13D follows the following steps:
A. 1301 (FIG. 13A) positioning the instrument (container and basket) with the folded (closed) conical headend basket 220b of the delivery instrument 200b on the intermediate shaft 30 of the valve with the support adjacent the annulus. (Shown in side view, valve and annulus in cross-sectional side view).
B. Inflate balloon 228b (FIG. 13B) at delivery instrument distal end 230b by pushing button 1302 at operator end 214b to float delivery head 220b into the correct position within heart valve 16 . If necessary, rotate the delivery head to bring any section of the support body without bar hooks, or any void in the support body, or any sheathed part, into delicate or sensitive tissue. Align to any section of the annulus that contacts.
C. The control unit 1150 is slid 1208 or twisted to expand the basket 1306 to bring the support body 110a into contact with the distorted annulus 18. The support has a bar hook, and the support is attached to the tissue by being embedded in the valve tissue at the periphery 121 of the annulus 18 when the bar hook is in contact (FIG. 13C).
D. When the basket 220b reaches the desired diameter 1303, the expanded heart valve support 110a causes the annulus 18 to have a desired configuration (eg, annulus) and a desired final diameter (eg, in diameter) of the annulus. Match with larger size. Optionally, the wire loop 1102 is pulled 1104 and the coil of the support body 110a is tightened to obtain a smaller final diameter.
E. When the heart valve support is in its final position, pull 1304 to disengage the instrument from the support attachment 246b (FIG. 13D) and place the support in its final size (including final diameter 1309) and shape Shrink 1308, leaving the support permanently in place to maintain the annulus in the desired final configuration and size. The balloon 228b is compressed 1311 by pressing the button on the operator side end.

  As shown in FIGS. 14A-14D, in some embodiments, the support is constructed from several pieces that include a multi-loop annular coil 302 with the elasticity of the strip material 304. The coil is housed in a tubular torus type sheath 306. A large number of bars or hooks 308 (the number can be, for example, 20-60, but much more, even several orders of magnitude more, or in some cases fewer May be mounted at regular small intervals 310 around the circumference of the torus sheath.

  In some embodiments, the multi-loop annular coil is made of a Nitinol strip that is about 1/8 inch wide and about 10 / 1000-15 / 1000 inch thick. During fabrication, the Nitinol strip is shaped into a coil having the desired final embedded diameter. As described below, the Nitinol coil is expanded for insertion purposes. During expansion, the strap ends 312, 314 move circumferentially around the coil (in the direction shown by arrows 316 and 318) to accommodate the increase in ring diameter. 14A-14D, the ring is shown with its unstressed natural diameter corresponding to the desired final embedded diameter. The number of loops can vary depending on the material used, thickness, and other considerations. In some embodiments, the number of loops can be 3.5, or 5 or 8, or other numbers in the range of 1-10 or more.

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

  In some embodiments, the overall shape of the coil, including non-annular and non-planar shapes, may be different from the shape shown in FIG. 14A.

  The coil (or other elastic coring) is retracted and pulled to the desired shape sufficient to be pushed over the heart annulus, sufficient to be expandable to accommodate the delivery device. Have sufficient strength and durability to form a long lasting and strong support for the annulus, sufficient to withstand the force generated when breaking the insertion instrument, and is necessary. It is also essential for the intra-cardiac forces that are sufficient to allow the support and the annulus to which it is attached to retract to the desired shape and size after insertion and that may act on the support. It is also necessary to have sufficient elasticity to hold the support in its shape and size.

  In some embodiments, a biocompatible material is used where the material from which the coil is made can be exposed to the blood or tissue of the patient.

  In particular, the coil is retained within the sheath 306 so that the coil slides within the inner lumen of the sheath as the coil expands for insertion and contracts after insertion. The sheath has elasticity to move it radially relative to the coil during expansion and contraction. Since the bar or hook (the inventor may refer to the bar and hook and a wide variety of other gripping devices as the gripper) is mounted on the sheath rather than on the coil, the gripper relative to the center axis of the support Coil expansion and contraction can occur without any disruption of the angular position.

  In some embodiments, the sheath can be formed of a simple tube. To embed a coil in such a tube, the coil can be unwound and repeatedly wound through the tube until all turns of the coil are embedded. When the coil is fully embedded in the tube, the assembly can be completed by pulling up one end of the tube and bonding it to the other end.

  In some embodiments, the sheath can be formed of a specially shaped piece, which has a torus shape formed during molding and includes a method of securing the two ends together. .

  In some embodiments, the sheath is intended to be sealed to prevent fluid from entering the tuft containing the coil. In some cases, the sheath is not sealed and fluid can pass freely. In some embodiments, using fluid to fill the space in the sheath provides lubrication for sliding of the coil in the sheath and can cause problems when the support is used in the heart. There is a replace air. The fluid can be, for example, blood or saline.

  The sheath must be strong enough to encapsulate the coil without breaking even when the support expands and contracts before, during and after placement in the valve. As the diameter of the support expands and contracts, the cross-sectional diameter also tends to change, and this amount of change can disrupt the attachment of the gripper to the valve tissue or cause the coil to slide within the sheath, in particular. It must not be constrained or large enough to misplace or misalign the gripper relative to the sheath. The sheath may be elastic so that the sheath contracts along the coil when the support contracts after expansion.

  A wide variety of materials can be used for the sheath including, for example, silicones, plastics and fabrics. Combinations of materials can also be used.

  As shown in FIG. 14D, the outer surface 322 of the sheath may have a groove 323 that accommodates (and keeps in place) a portion of the gripper as described below. In some embodiments, the grooves are parallel and may be present at evenly spaced intervals around the sheath.

  The cross-sectional diameter of the sheath is such that the inner lumen can accommodate and slide the coil and the outer surface can be long enough to support the grasping body and through the heart valve after the support is installed. It may be short enough not to interfere with proper blood flow.

  As shown in FIG. 15, in some embodiments, each of the grippers can be formed on a length of wire, the wire being approximately the same (or slightly less than the diameter of the sheath cross-section). A closing ring 324 having a diameter 326. The straight section 328 extends from the ring and has a gripper 330 formed at its free end.

  The present inventors sometimes refer to the entire piece including the grip body and a portion for attaching the grip body to the support body as the anchor 332.

  In some embodiments, the anchor is prefabricated using a ring in the final shape and a gripping body protruding from the ring. In some examples, the anchor is formed of stainless steel or another biocompatible material.

  A wide variety of materials, including metals and plastics, and combinations thereof can be used to fabricate each or a group of anchors. The cross-sectional shape of the anchor can vary and can be, for example, circular, elliptical, flat or bent, or various other shapes.

  In some embodiments, the anchor can be made from a small fishing hook having a hook end that serves as a gripping body and a second end that is bent to fit over the support.

  The thinner the anchor is in the direction along the circumference of the sheath, the greater the number of anchors that can fit on the support. In some embodiments, a greater number of thinner anchors are useful in easily installing and activating the support. In some cases, the placement of the anchors along the sheath can be other than regular and closely spaced. For example, the spacing can vary along the sheath, or the number of anchors can vary along the sheath.

  To place the anchor, the ring can be pulled open and slid over the sheath and then released. In an example in which the outer surface of the sheath is molded and has a groove, the ring portion of the anchor can be seated in the groove.

  In some examples, all attachment of the anchors is such that their grips are directed to a common angle 336 from the central axis 338 of the support, as shown in FIG. 14D (some of the anchors are not yet attached). Can be done. In some examples, the gripper may be at different angles with respect to the central axis.

  In some examples, the anchors can be mounted such that the anchors tend to maintain their installed orientation without sliding or rotating around the outer surface of the sheath. In some embodiments, as the support expands and contracts before, during, and after insertion into the heart valve, the extension and relaxation of the sheath changes its cross-sectional diameter, thus opening and closing the ring, and It can cause a corresponding reorientation of the angle of attack of the gripper tip. This effect can be useful in placing the gripping body in the valve tissue and providing its secure attachment.

  In some cases, if the point of attack angle is shared by all grippers, it may not be desirable that the spacing between successive anchors along the perimeter is too close 310. This is because adjacent grasping body tips may interfere with each other during insertion and may be less effective in grasping the valve tissue. For this reason, in some embodiments, the angle of attack at the tip of the gripper may vary slightly from anchor to anchor, which is more tight while still allowing some clearance between successive grippers. Allow spacing. In some cases, the orientation of successive grippers can alternate around the centerline. Other arrangements are possible.

  In FIGS. 14A-14D and 15, the anchors are shown as having a single free end each having a tip 340. FIG. In some embodiments, each anchor may provide an extension (eg, a symmetric extension) at the other end 342 of the wire implied by dashed line 344. A wide variety of other arrangements are possible.

  In FIG. 15, the gripping body has three needle-like protrusions on each side of the free end of the wire. In some embodiments, there may be more or fewer needle protrusions, and the needle protrusions may have a wide variety of other configurations on the gripper.

  In some embodiments, each of the gripping bodies 350 can be formed of a wire or other cylindrical material, and two each at an angle 358 of, for example, 25 degrees with respect to the central axis 360 of the gripping body. For example, it can be formed, machined or molded to have the configuration shown in FIGS. 16 and 17 including a tip 352 having a symmetry plane 354,356. Slots 362 and 364 can be laser cut, machined or otherwise applied at a common angle to the central axis (15 degrees in this example), resulting in two needle-like projections under the tip. It is formed.

  Once the acicular protrusions are formed, the final acicular protrusions can be formed by bending them away from the axis in directions 366 and 368.

  A wide variety of other configurations and manufacturing configurations are possible for the acicular protrusions and gripping bodies. In the particular example shown in FIGS. 16 and 17, the gripping body is formed of nitinol wire with a diameter of 1.26 mm, and the length from the gripping body to the lower edge of the slot is 22.87 mm.

  As shown in FIG. 14D, in some examples, at the time of installation, each of the grippers extends from about 2 to about 4 millimeters (dimension 339) from the bottom of the sheath surface.

  In some embodiments, a support comprising a coil, a sheath, and a portion of an anchor is encased in a fabric cover, as are many existing rings that are manually sutured to the annulus by the surgeon. The fabric helps ensure repair by firmly attaching the heart tissue to the support over time.

  As shown in FIG. 18, in some cases, the fabric cover may be a thin strip of material spirally wrapped around other portions of the support. The material can be attached to the support by stitching, gluing or other methods. Helical wrapping allows the use of non-resilient materials and still accommodates the circumferential expansion of the support. In some examples, the fabric cover may include a series of independent tubular fabric segments disposed on the support. The segmented arrangement allows the use of a non-resilient fabric without disturbing the circumferential expansion of the support.

  In placing the fabric on the support, it is placed over the gripping body, and each of the gripping bodies has entered the fabric and is ready for insertion. There is a possibility to use a wide variety of coating materials or combinations thereof, including metals, fabrics and plastics. The cover should be able to accommodate the expansion and contraction of the support without being distorted and should be sufficiently biocompatible and porous to allow and encourage tissue growth through its structure.

  A wide variety of other component and material configurations and methods of assembling the support components are possible. Different numbers of pieces can be used and the functions described can be combined in different ways into different pieces of the support.

  In some examples shown in FIGS. 19, 20, and 21, the sheath can be made of two molded pieces that occlude. The outer ring-shaped housing 402 (sometimes referred to as the outer piece) has upper and lower flat rings 404, 406 connected by an outer flat cylindrical wall 408. A coil 407 is present in the housing. The other inner piece 410 of the sheath is a cylindrical wall, which allows the inner end 408 of the coil to slide in the circumferential direction 409 to tighten or loosen it Is captured between the upper and lower rings 404, 406 to expand or contract the support. During the sliding, the inner piece of the sheath also slides in the circumferential direction.

  In this example, anchor 412 is formed from a flat piece of metal that is bent and attached to the outer piece of the sheath. Each anchor includes an upper finger 417 that captures the upper portion of the outer piece of the sheath, a vertical arm 419, and a lower finger 414 that captures the lower portion of the outer piece of the sheath. The gripping body 416 extends downward from the lower finger. The inner piece of the sheath has a tab 418, which can be expanded or contracted by manipulating the tab to pull or release the end of the coil. For this purpose, the opposite end of the inner piece of the sheath is attached to the end of the coil. As a result, the support can be expanded or contracted without the anchor moving relative to the outer piece of the sheath. The tab 418 can be manipulated in a wide variety of ways, including direct finger manipulation, use of an insertion instrument during thoracotomy, or manipulation at the end of the catheter at different locations within the catheterization room.

  As shown in FIGS. 22-27, in some embodiments of the gripper, there is a pointed end 430 and a pair of needle-like protrusions 432, 434, 436, 438 on each side of the pointed end. In the example shown in FIGS. 22 and 23, the needle projections 434 and 438 are smaller. In the example of FIGS. 24 and 25, the two acicular protrusions on each side of the tip have a similar size and shape.

  As shown in FIGS. 26 and 27, in some examples, the detailed configuration of the nitinol strip includes a tip and a needle-like projection. As shown in FIG. 21, in some configurations, the needle-like protrusion is bent out of the plane of the strip from which the gripper is formed in order to be more effective as a needle-like protrusion.

  In general, in some examples, the support to be implanted in the valve tissue can be configured to perform three related functions. (1) Ability to easily insert the support gripper into the tissue once the support is correctly positioned on the annulus; (2) Partially capable of causing separation of all or part of the support after insertion The ability to hold the support firmly in the tissue to maintain the precise shape of the valve annulus and to be durable and long-lasting by providing substantial resistance to sexual forces; (3) The ability to intentionally withdraw all or part of the gripper during or after the insertion procedure to reposition or reorient the support relative to the annulus when it is useful to do so. These three functions require careful and delicate design of the gripper, anchor, and other parts of the support. This is because some design elements preferred for one function can negatively affect another function. These functions should also be implemented in equipment that is simple, easy to operate and easy to use.

  For example, easier insertion of the grasping body into the tissue can be achieved by reducing the size and profile of the acicular protrusions on the grasping body and directing the tip of the grasping body directly into the tissue. Removal of some or all grippers to reposition the support is also assisted. However, these same features can reduce the stability and durability of attachment of the support to the tissue. Giving a wider or disturbing profile to the acicular process or removing the tip of the gripping body from the direct path to the tissue makes the gripping more secure, but inserting the gripping body is similar to repositioning It becomes difficult.

  Design features that can be adjusted and traded off to achieve the desired mix of required functions include the number of anchors, grippers and needles, shape, size, orientation and mounting method, shape of the body of the support, There are size, orientation and other configurations, materials used for all parts of the support, and a wide variety of other factors.

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

  For example, as shown in FIGS. 28-31, the support 450 may include anchors in the form of, for example, 30 loops 452 that are equally spaced around the body 454 of the support. The cross section of the body 454 may include an annular segment 456 along the inner periphery of the body and a flat or concave section 458 along the outer periphery of the body. Each of the loops may include two free ends 460, 462, while 460 is not sharp and the other 462 has a sharp point. The loop has no acicular features.

  In some modes of operation, the curved sharp edges 462 of all grippers can be held away from the body and oriented in the general direction of the annulus tissue prior to insertion. A sheath or other mechanism may be used to move them into this temporary insertion position and keep them there. During insertion, an insertion instrument may be applied to push the grasper into the tissue. As shown in FIG. 31, when the pointed end of the gripper is in the tissue, the sheath or mechanism follows the curved path 464 through the tissue 466 and after exiting the tissue and adjacent to the support body. , May be manipulated to cause the anchors to take their final shape.

  This configuration has the advantage that a similar sheath or mechanism can be used to reverse the process so that the grasper can be pulled through the tissue and returned to the configuration of FIG. Reversing the process is relatively easy because gripping is achieved by the curvature of the shaft of the anchor rather than the needle-like protrusions on the sharp tip. The gripping is reliable. However, insertion can be more difficult than in other embodiments, and reversibility requires additional mechanisms.

  In some examples, the support may be provided with an adjustment and locking feature that allows the surgeon or operator at the time of insertion to adjust or size the support (e.g., diameter) and possibly the shape. Allows locking or both. In some cases, the support may be adjusted to different sizes possible at the time of insertion, rather than needing to reach only a single non-selectable design size.

  For example, as shown in FIG. 45, the core structure piece 570 of the support may be made of crimp stainless steel that is plastically deformed by an insertion tool (not shown). The instrument may engage the top of the structural piece, causing the piece to temporarily have a larger diameter for insertion. After the support is pressed into the annulus and the grasper is attached to the tissue, the instrument can be folded to fold the structural piece diametrically to its final size.

  As shown in FIG. 46, in some cases, the individual expansion elements 573, 575 have holes 576, 578 that extend or contract the structural piece exactly to the desired dimensions. At that point, it has a location and spacing that fits exactly with the location and spacing of the pins 582, 584 in the rigid locking element 580. The locking element is held in place in an annular silicone support having an inner peripheral wall portion and outer peripheral wall portions 574, 576 connected by an upper annular wall portion 578. When the silicone support is properly sized, the pin of the locking element is pushed into the hole by depressing the support.

  With reference to FIGS. 47-53, in some embodiments, the support 600 may be formed of three pieces.

  One of the pieces, a ring-shaped elastic (eg, silicone) ring 606, has a cross section that includes four straight segments that define a trapezoid that provides stability to the shape of the ring. There are four corresponding faces of the ring. The surface 632 has a configuration that is designed to match the surface of the surface of the dilator portion of the insertion instrument.

  The second piece is a metal ring 604 formed from, for example, a stainless steel strip having a curved cross section and two overlapping ends 620 and 622. The cross-sectional curvature maintains the axial stability of the ring. Near one end 622, the ring has a series of slots that are intended to mate with corresponding tabs 623 formed near the other end 620. During fabrication and assembly, the tabbed end of the ring is inside the overlapping section 627, so that fitting and locking cannot occur. However, when finally installed, the tabbed end is outside the overlapping section to allow locking. During manufacture, a silicone ring is molded around the metal ring. As the silicone ring is extended and relaxed, the metal ring can expand and contract because the two ends move freely relative to each other in the overlapping section. The support is essentially spring loaded.

  The third piece of this exemplary support is a doubly pointed anchor 602, many copies of which are arranged around the ring (although regularly spaced in this version). , Not necessarily). In some embodiments, each of the anchors is made from a single loop 602 of wire having a gripper (eg, a needle or a hook) at the opposite free ends 616, 618. Each of the anchors is elastic and has the relaxed state shown in FIG. 53, with a distance 619 between the two grippers, with the two grippers generally pointing toward each other. The anchor loop is placed on the metal ring and potted in the molded silicone ring.

  After assembly, the support is extended to a larger diameter and mounted on an insertion tool (not shown). Extension has two effects. One is that the two ends of the metal ring are sufficiently separated to eliminate overlap, as shown in FIG. The end of the ring is deflected so that the tabbed end moves outward relative to the slotted end. Thus, the tab is positioned to mate with the slot when the two ends again form an overlap when the ring is later retracted. The end of the metal ring is chamfered to help achieve this arrangement when the ring contracts.

  Moreover, when the silicone ring expands, the cross-sectional diameter of the silicone ring shrinks. Because the anchor is potted in the silicone ring, the matrix compresses the anchor loop 610 into the temporary configuration shown in FIG. 48 as the ring extends in length and contracts in diameter. In that configuration, the distance 619 increases and the orientation of the tip of the gripper rotates to generally oppose the insertion direction and is ready for insertion.

  As shown in FIG. 52, when the insertion tool is removed from the support, the support contracts in diameter, thereby reconfiguring the annulus to the desired shape and size. The silicone ring expands in cross-sectional diameter, which relaxes the anchor (FIG. 53), causing the gripper to rotate and push the tips toward each other and remain firmly on the tissue. As the metal ring contracts, the tabs and slots cooperate in a ratcheting action, thereby contracting the support to its final shape and size while preventing reverse expansion from occurring again.

  In some cases shown in FIGS. 54 and 55, locking of the final diameter of the support can be accomplished by embedding a mating element in the elastic ring 700. A set of elements 704 can be embedded in one plane of the ring, and a corresponding set of elements 706 to be mated can be embedded in the second plane of the ring. The embedding is performed so that the two different types of mating elements slide relative to each other as the support is expanded and contracted before and during installation. When the appropriate diameter of the support is reached, the instrument can be used to push down on the silicone ring so that the mating element occupies the same plane and engages.

  In some examples, two occlusal elements 722 and 724 may be formed at the end of the elastic metal coil 720 that forms part of the support. Once installed and properly sized, the support can be locked by pressing down on the occlusal element.

  In some cases, the support may have a central annular lumen, the lumen is filled with uncured polyurethane so that the support diameter and / or shape can be adjusted upon insertion. It is arranged. When the desired diameter and / or shape is reached, the polyurethane is cured and solidified using ultraviolet light that may be delivered through a delivery device or otherwise. Curing can be done in about 20-30 seconds with current curable materials and lighting.

  FIGS. 32-35 illustrate another exemplary configuration that allows a reversible process for placing and removing the grasper from the annulus tissue for repositioning. Each of the anchors 470 includes a scissor or scissor mechanism that includes two pointed (but not acicular) grippers 472 on opposite free ends of a 0.015 inch Nitinol wire loop. 474. In order to form each anchor, a wire is wound on a jig in a shape 476 shown in FIG. 32 which is an opening configuration of the anchor. Next, the opening shape is memorized and set using heat. The loop diameter 478 in this example may be about 0.20 inches for mounting on a torus-type elastic extensible support body having a cross-sectional diameter 480 of about 0.25 inches.

  As each anchor loop is opened and pushed onto a larger diameter 480 support body, the anchor configuration automatically closes the two pointed free ends into the gripping configuration shown in FIG. . Prior to installation and prior to placing the support on the insertion tool, the support body is in its contracted installation configuration shown in FIG. 33, with all scissors closed. In FIGS. 34 and 35, the support has been extended to its insertion configuration, in which the diameter 482 is larger and fits over the insertion instrument 484 (simulated here). Because of the shape and configuration of the support body (eg, silicone tube), when the body is stretched, its cross-sectional diameter is reduced and the anchors are relaxed to their inherent opening shape and ready for insertion.

  The insertion proceeds by pressing the support toward the opened appropriately shaped valve annulus and allowing the sharp tip of the grasping body to enter the tissue. Upon removal of the insertion tool from the support, the support body shrinks to the desired final shape and diameter of the annulus. As it contracts, the scissors grip the annulus tissue and keep the support firmly in place. The support is therefore relatively easy to insert and can be removed and repositioned by reversing the process, i.e. expanding the support body to release the scissors.

  A wide variety of insertion instruments (also sometimes referred to as dilators) can be used to attach the support to the heart annulus tissue. Some have been described previously, and the inventors describe others below.

  An important principle of construction and operation of at least some examples of insertion instruments is that surgeons or catheter operations are reliably and easily performed in a wide variety of patients with heart valves in a wide variety of states and with a wide variety of shapes and sizes. They allow a person to install a support. In other words, the insertion can be done routinely and simply. This can be done with an insertion instrument that automatically and easily temporarily expands and reconfigures any heart valve annulus to take a common expanded shape and / or size. This allows the pre-expanded support to be attached to a common shape and / or size without concerns regarding the non-extension context and configuration of the patient's annulus. After insertion, the support is configured so that the support can be reconfigured to a desired and stable desired final shape and size, either automatically or by manipulation, with the insertion instrument removed.

  FIGS. 36-39 illustrate an example of an insertion instrument 500 that includes a dilator 502 formed of six arms 504 that are equally spaced about an insertion axis 506. Each of the arms is formed of a 0.125 inch wide spring steel metal strip bent at two points 508 and 510. The arm ends 512 gather together and are held by the segments of the plastic tube 513 at the end of the aluminum inner tube 514 (outer diameter 0.28 inch, inner diameter 0.24 inch). The opposite ends 516 of the arms gather together and are kept in the aluminum outer tube 520 (outer diameter 0.37 inch, inner diameter 0.30 inch) by the tube segment and shaft collar 518. The outer tube is connected to the handle 522. The inner tube that slides in the outer tube along the insertion axis is operated by the second handle 524.

  By pushing or pulling the second handle against the first handle 526, the inner tube moves back and forth relative to the outer tube, which causes the arm to expand as shown in FIG. 38 and as shown in FIG. Shrink. For example, a thin molded sleeve 530 of silicone protects the mechanism from damage and protects the heart tissue and support. Prior to placement of the support within the heart valve, the support is stretched and mounted on the dilator at the central ridge 532. It can be held in place by force and friction, or can be tied with sutures that are cut after installation, or a recess in which the support seats can be provided in the central ridge. Another view of the central ridge 532 is shown in FIG.

  As shown in FIGS. 42 and 43, in some examples, the dilator may include circular wire arms 550 that are evenly spaced around the insertion axis, and FIG. Each of the expanded configurations shown in FIG. Each wire end 552, 554 is secured to two annular hubs 556, 558, respectively. Upper hub 556 has a center hole (not shown) that is threaded to receive threaded rod 560 on which handle 562 is clamped. The other end 559 of the threaded rod is fixed to the hub 558. Use the handle to turn the threaded rod 564 to advance it through or pull it out through the upper hub toward or away from the lower hub (depending on the direction of rotation). The rod pushes or pulls on the lower hub, thereby increasing or decreasing the distance 566 between the two hubs, causing the arm to contract or expand to the shape-expanded configuration.

  As shown in FIG. 40, in some embodiments, each arm 538 of the insertion instrument 540 is formed with a rigid limb 544 that is at one end 546 to the outer tube 548 and at the other end 549 is a wider limb. Connected to section 550. The other end 551 of the second limb is connected to the inner tube 554 at the tip 556. These limbs are connected by hinge elements that cause them to pivot relative to each other. On each of the arms, the clip 560 has a recess that captures the support at one location along its circumference.

  FIG. 41 shows a support mounted on an insertion instrument ready for insertion.

  58 and 59 show a version 730 of the support. This version 730 has a ring of continuous hexagonal sections 732, 734 in contact with the short edges 736, 738. At the junction of the longer edges 740, 742, 744, 746 of the hexagonal section, there 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 the needle-like protrusion for grasping the tissue 757 penetrated by the sharp free end 750 with the needle-like protrusion. 752, 754, 756. The sharp free end 750 with all needle projections points in the same direction 751 on all hexagonal sections 732,734. The other set of free ends 748 do not have needle-like projections and, if present, further stabilize the support by penetrating other adjacent tissue, holding them inward, and supporting the Can be further fixed to the tissue. All other free ends 748 point in the same direction 753 opposite to the direction 751 in which the sharp free end 750 with needles faces.

  This version 730 of the support is elastic and expandable to the delivery configuration and then contracts to the final configuration. As shown in FIGS. 60A and 61A, each hexagonal segment 732 increases in width 770 and decreases in height 772 as the support is expanded 760 to a larger diameter 762, for example, in a delivery configuration with a delivery device. As shown in FIGS. 60B and 61B, each hexagonal section 732 decreases in width 770 and increases in height 772 as the support contracts 764 to a smaller diameter 766 in the final configuration. In some embodiments, this version 730 of the support, such as nitinol or a biocompatible elastomer (or other material), configured to 764 shrink the support to its final configuration after insertion into tissue. It can be made of a flexible shape memory material. For example, the support can be configured to contract upon exposure for a period of time at the body temperature of the human body.

  Other embodiments are within the scope of the following claims.

Claims (84)

Comprising a cardiac tissue support having a grasping element;
Each gripping element has a free end that is sufficiently sharp to allow entry into the tissue when pressed against the heart tissue and a feature that resists withdrawal of the gripping element from the tissue after the sharp free end has entered the tissue; apparatus.   2. The device according to claim 1, wherein the free end of the gripping element protrudes away from the surface of the support.   The apparatus of claim 1, wherein the feature that resists withdrawal of the grasping element from the tissue includes fingers that project laterally from the grasping element.   The device of claim 1, wherein the cardiac tissue support includes an annular surface having a grasping element.   The device of claim 1, wherein the support is expandable and contractible.   6. The apparatus of claim 5, wherein the support has a configurable characteristic size.   7. The device of claim 6, wherein the wire sets a unique size.   The device of claim 1, wherein the support comprises at least one of stainless steel, gold, nitinol or a biocompatible elastomer.   The apparatus of claim 1, wherein the support comprises a torus.   The apparatus of claim 1, wherein the support comprises a helically wound portion.   The apparatus of claim 1, wherein some portions of the support do not have gripping elements.   The apparatus of claim 1, wherein the gripping elements are organized as a pattern.   The apparatus of claim 12, wherein the pattern comprises a column.   13. The apparatus of claim 12, wherein the pattern comprises a group in which gripping elements are arranged at a higher density and a group in which gripping elements are arranged at a lower density.   The apparatus of claim 12, wherein the pattern comprises an arc.   The apparatus of claim 12, wherein the pattern comprises clusters.   The apparatus of claim 12, wherein the pattern comprises a random arrangement.   The 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. apparatus.   The apparatus of claim 1, wherein the gripping elements have the same size.   The apparatus of claim 1, wherein some of the gripping elements have different sizes.   The apparatus of claim 1, wherein at least some of the gripping elements have two or more features that resist withdrawal.   The apparatus of claim 2, wherein at least some of the gripping elements project orthogonally from the surface.   The apparatus of claim 1, wherein at least some of the gripping elements are curvilinear.   The device of claim 1, further comprising a sleeve through which the tissue can grow.   25. The apparatus of claim 24, wherein the sleeve comprises polyethylene terephthalate.   The apparatus of claim 1, wherein between about 15 and 1 million gripping elements are present on the support.   The apparatus of claim 1, wherein there are about 100 to about 100,000 gripping elements.   The apparatus of claim 1, wherein the gripping element comprises a bar hook.   The apparatus of claim 1, wherein the gripping element comprises a sagittal body.   The apparatus of claim 1, wherein the gripping element comprises a hook. Orienting the tip of the catheter holding the cardiac tissue support with the grasping element to the heart annulus and opening the structure at the tip of the catheter applies a radial force from the catheter to the annulus, opening the structure. Correcting the shape of the annulus in the catheterization chamber by pushing the support onto the annulus during the operation. A method comprising correcting an annulus shape during a surgical procedure by pressing a cardiac tissue support having a grasping element onto the heart annulus. A support that is expandable in preparation for attachment and contractible to the normal relaxed, unexpanded native size when in place on the annulus is attached to different sized heart annulus in different patients And to reduce the size of at least some supports in place to be smaller than the normal relaxed unexpanded inherent size to accommodate different sized heart annulus of different patients Including methods. Including a number of small grasping bodies each having tissue invasion and retention features;
The configuration of the gripper for the configuration of a given area of heart tissue to which the support is to be attached by force is
(1) The intrusion feature of a pair of gripping bodies that fail fails to invade the tissue,
(2) The intrusion feature of the second set of grasping bodies successfully penetrates the tissue,
(3) the retention feature of the subset of the second set of grasping bodies fails to retain the grasping bodies in the tissue;
(4) The second set of remaining gripper retention features is a configuration that is successful in retaining the gripper in tissue and maintaining the support on the tissue in the intended configuration.
Heart tissue support. In order to embed and retain in the tissue only a portion of several small grips on the support that are sufficient to secure the support to the heart tissue, A method comprising a step of pressing up. An apparatus comprising an annular heart valve support that is expandable and contractible and has a grasping element, the grasping element entering the heart tissue and holding the element in the tissue after entry .   An instrument that attaches a support to a heart valve annulus, keeping the support in an expanded configuration prior to installation, allowing the heart annulus to expand before installation, and attaching the support to the expanded annulus in its expanded configuration And a mechanism including a mechanism that releases the expanded support after installation to a contracted configuration.   38. The device of claim 37, attached to the end of a catheter.   38. The device of claim 37, further comprising an inflatable balloon.   40. The instrument of claim 39, wherein the balloon serves to position the instrument.   38. The instrument of claim 37, wherein the mechanism is also a mechanism for removing the instrument from the heart after attachment.   An instrument for attaching a support to a heart valve annulus, the instrument comprising a structure for expanding the heart annulus to a predetermined shape under the control of an operator.   43. The device of claim 42, wherein the structure has a conical outer surface and at least a portion of the outer surface conforms to a predetermined shape.   43. The device of claim 42, wherein the structure has an outer surface that is expandable to a predetermined shape. A gripping element that adheres to the biological tissue and holds the support firmly in place;
Coupled to the gripping element,
Adjust the support between the first configuration for installing the support and the second configuration where the support is securely held in place after installation, and be self-supporting in the first and second configurations is there,
An apparatus comprising a support for biological tissue having an annular structure.   46. The apparatus of claim 45, wherein the biological tissue comprises heart tissue.   46. The apparatus of claim 45, wherein the biological tissue comprises a heart valve annulus.   46. The apparatus of claim 45, wherein the grasping element is configured to penetrate the tissue during installation and grasp the tissue after installation.   46. The apparatus of claim 45, wherein the annular structure is circular.   46. The apparatus of claim 45, wherein the annular structure has elements that adjust the support between the first configuration and the second configuration by moving in an annular fashion relative to each other.   46. The apparatus of claim 45, wherein the annular structure is greater when the support is in the first configuration than when the support is in the second configuration.   46. The apparatus of claim 45, wherein the annular structure changes its shape to adjust the support.   46. The apparatus of claim 45, wherein the annular structure changes its shape during installation without changing the location of the grasping element relative to the living tissue.   A ring-shaped structure is slidable relative to the first element when the gripping element is attached and the ring-shaped structure is slidable relative to the first element when adjusting the support between the first configuration and the second configuration; 46. The apparatus of claim 45, comprising two elements.   55. The apparatus of claim 54, wherein the first element includes a resilient annular tube to which a gripping element is attached, and the second element includes a rigid adjustable piece that is slidable within the tube.   55. The apparatus of claim 54, wherein the second element comprises a free standing coil.   56. The self-supporting coil comprises a rigid strip material having two free ends capable of adjusting a support between a first configuration and a second configuration by moving relative to each other. apparatus.   46. The apparatus of claim 45, wherein the annular structure includes a feature that defines a spacing between gripping elements coupled to the annular structure.   46. The apparatus of claim 45, wherein the gripping element is adjustable between a first arrangement for installing the support and a second arrangement in which the support is held securely in place after installation.   The ring-shaped structure and the gripping element are automatically adjusted between the first and second arrangements when the support is adjusted between the first and second arrangements 60. The apparatus of claim 59, wherein the apparatus is configured to.   The annular structure includes a cross-sectional area that increases when the support is adjusted between the first and second configurations, and the gripping element is coupled to the annular structure, thereby reducing the cross-sectional area of the annular structure. 61. The apparatus of claim 60, wherein the gripping element is adjusted between the first arrangement and the second arrangement in doing so.   Each of the gripping elements includes a loop and a penetrating element attached to the loop, wherein the orientation of the penetrating element changes as the configuration of the loop changes between the first arrangement and the second arrangement. 59. The device according to 59.   46. The apparatus of claim 45, wherein adjustment of the support between the first configuration and the second configuration is reversible without the gripping element damaging tissue.   46. The apparatus of claim 45, wherein the annular structure includes a lock that prevents a change in configuration of the support.   65. The apparatus of claim 64, wherein the lock includes a pair of mating elements.   66. The apparatus of claim 65, wherein one of the mating elements includes a tab and the other includes a slot.   66. The apparatus of claim 65, wherein one of the mating elements includes a pin and the other includes a hole for the pin.   65. The apparatus of claim 64, wherein the annular structure includes a central axis and includes two portions that are movable relative to each other about the central axis toward a position where the mating element mates. A tip that invades living tissue;
An elastic loop that supports the tip, comprising a gripping body that includes a relaxed configuration and an elastic loop having a non-relaxed configuration;
The device, wherein the tip has a different orientation associated with each of a relaxed configuration and a non-relaxed configuration.   70. The apparatus of claim 69, wherein the tip has at least one acicular protrusion.   70. The apparatus of claim 69, wherein a gripping body includes two or more said tips.   70. The device of claim 69, wherein the tip support is an elastic support having the following configuration.   70. The apparatus of claim 69, wherein the gripper comprises a wire.   70. The apparatus of claim 69, wherein the loop is circular.   70. The apparatus of claim 69, wherein the gripping body comprises a forming strip of material.   70. The device of claim 69, wherein there are two said tips that oppose each other and act as pincers in at least one of a relaxed configuration and a non-relaxed configuration. A circular, self-supporting elastic ring having a relaxed diameter corresponding to a healthy heart valve and an enlarged diameter adapted to the insertion instrument;
A heart valve repair ring comprising a gripper attached to an elastic ring and oriented in a direction that automatically changes between an insertion orientation and a placement orientation during placement. To correct the shape of the heart annulus, push the pointed gripping body on the support to penetrate the annulus tissue and keep the support firmly on the annulus, and damage the heart annulus Without removing at least a portion of the support from the annulus by withdrawing at least some of the pointed grips. Mounting an expanded elastic support on the heart annulus,
Shrinking the support to a healthy annulus diameter and locking the contracted support at the contracted diameter by engaging elements of the support. Placing the grasping element coupled to the heart annulus support ring within the annulus tissue by retracting the support ring from an expanded size to a smaller size during installation. The support includes an annular element, and a pair of annular elements are connected along the edges of the elements to form a ring;
The device of claim 1. Each of the annular elements has at least one of the gripping bodies;
82. The apparatus of claim 81.   83. The apparatus of claim 82, wherein each annular element further comprises a pointed element that faces away from the gripper.   82. The apparatus of claim 81, wherein each annular element comprises a hexagon.

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