JP2017517343A - System and method for heart valve fixation - Google Patents

Abstract

A system and method for percutaneous heart valve replacement includes implanting a heart valve replacement prosthesis into tissue and driving the anchor into the heart valve replacement prosthesis to secure the prosthesis to the tissue.

Description

CROSS REFERENCE TO RELATED APPLICATIONS This application claims the benefit of US Provisional Patent Application No. 62 / 010,680, filed June 11, 2014, and is hereby incorporated by reference in its entirety. .

  In addition, the following: U.S. Patent Application No. 14 / 321,476 filed July 1, 2014, U.S. Patent Application No. 14/301, filed June 10, 2014, No. 106, US Patent Application No. 13 / 843,930 filed on March 15, 2013, International Application No. PCT / US14 / 30868 filed on March 17, 2014 U.S. Patent Application No. 13 / 010,769, filed January 20, 2011, U.S. Provisional Patent Application No. 61 / 296,868, filed Jan. 20, 2010, US Patent Application No. 13 / 010,766 filed January 20, 2011, US Patent Application No. 13 / 010,777 filed January 20, 2011 And filed on January 20, 2011 U.S. Patent Application No. 13 / 010,774 Pat, the contents of each of which are incorporated entirely herein by reference.

  The present invention relates to a system and method for percutaneous heart valve replacement comprising anchoring a heart valve replacement into tissue.

  Heart valve replacement has been developed to combat heart valve defects resulting from heart valve regurgitation (ie, the heart valve does not close properly), or heart valve stenosis (ie, the heart valve does not open properly). Early attempts at heart valve repair and replacement included open surgical procedures, but more recent developments included percutaneous surgical applications.

  However, percutaneous heart valve repair presents certain drawbacks. For example, percutaneous repair involves a modified surgical technique, but such a technique can limit the benefits of the procedure. Annular rings are ineffective and can include the risk of erosion, perforation, and coronary thrombosis. Repair between edges may be technically demanding and may lack long-term durability. Depending on the specific valve defect, a combination of different repair techniques may be required, which further complicates the procedure and limits its effectiveness.

  In contrast, heart valve replacement offers certain advantages, limits the risks associated with heart valve repair, and applies to a wider range of patients. However, open surgical means for heart valve replacement pose significant risks to the patient. Therefore, less invasive percutaneous heart valve replacement is needed.

  Existing percutaneous means include US Pat. No. 7,621,948 which describes a percutaneous insertion type heart valve prosthesis that can be folded inside a catheter for delivery to an implantation site. Another percutaneous means described in US Patent Application No. 2013/0144378 is available from CardiAQ Valve Technologies, Inc. Other percutaneous prosthetic valves include Neovasc Tiara, Valtech Cardiovalve, ValveXchange, Lutter Valve, and Medtronic, Inc. and Edwards Lifesciences Corporation valves.

  In providing a percutaneous heart valve replacement, it can be folded into the catheter for delivery and can exit the catheter to properly fit within the implantation site and perform its function as a valve. Providing an implant is a challenge. The implant valve must therefore be small enough to be folded into the catheter, but once implanted, it is large enough to provide the function of the valve and not large enough to impede ventricular flow It must be in a state.

  Furthermore, it may be difficult to secure the heart valve implant to the implantation site. That is because the implantation site may be irregularly shaped, lack calcium to secure the valve, or make it difficult to secure the implant valve in the proper orientation This is because there are cases.

  There is a need for a percutaneous heart valve means to fully and effectively address these challenges.

  According to a preferred embodiment of the present invention, an apparatus is provided for delivering, implanting and securing a heart valve replacement prosthesis to tissue. The device may include a ring, which may be sufficiently flexible to be folded into a small space, such as a catheter cavity. The ring may be elastic to automatically expand when released from its folded position within the catheter. If the implantation site has an irregular shape, the elasticity of the ring allows the ring to become the shape of the implantation site. The device may further include one or more leaflets coupled to the ring. The leaflet is effective in blocking fluid flow in the first fluid flow direction and allowing fluid flow in the second fluid flow direction.

  The system of the present invention may include an applicator that includes an applicator shaft that terminates with one or more spring arms at the distal end through the ring. The spring arm couples the distal end of the applicator shaft to the ring so that the spring arm applies a spring force to the ring and pushes the ring radially outward. Since each spring arm is separately coupled to the ring, in the case of multiple spring arms, each spring arm can individually respond to an implantation site having an irregular shape, so that the ring conforms to the shape of the implantation site. And makes it possible to provide a better seat for the prosthetic heart valve.

  The prosthesis can be delivered percutaneously to the implant site, for example by a catheter into which the prosthesis can be folded. Once delivered to the implantation site, the prosthesis may be pushed through the distal end of the catheter so that the ring can expand. The prosthesis can then be implanted at the implantation site, where the elasticity of the ring and independent spring arms allows the prosthesis to be in any irregular shape at the implantation site.

  Once implanted, in the preferred embodiment, a driver is used to drive the anchor through the ring and push into the tissue at the implantation site to secure the prosthesis to the tissue at the implantation site. The driver can be configured to push one or more anchors into one or more positions around the ring and index the drive of the anchor along each spring arm Can do. Once the prosthesis is secured to the implantation site, the applicator can be retracted, leaving the prosthesis secured in place. The width or diameter of the prosthesis is smaller than the width or diameter of the implantation site, so that once the anchor is driven and pushed into the surrounding tissue of the implantation site, the tissue at the implantation site is attracted towards the smaller prosthesis. This matches the outer shape of the prosthesis.

  Thus, the valve function is more fully and effectively improved by securely securing the prosthetic valve to the implantation site. The prosthesis may take various shapes. The shape of the prosthesis to be used for a particular application can be selected based on the specific geometrical needs of the particular application.

  According to a preferred embodiment of the present invention, the surgical device is an applicator, said applicator terminating in a distal end having one or more spring arms through the ring. And the spring arm is distant from the applicator shaft so that a proximally directed force applied to the applicator shaft is transmitted to the one or more spring arms and the flexible ring. An applicator having a distal end coupled to the ring, a driver, wherein the driver is annularly disposed about the applicator shaft, and at least one firing arm including at least one anchor outlet. The driver is configured to slide along the applicator shaft between a proximal position and a distal position. At least one firing outlet so that at least one anchor outlet is positioned parallel to the applicator shaft in the proximal position of the driver and at least one anchor outlet is directed to the flexible ring at the distal position of the driver. An arm is hingedly connected to the driver and the driver is configured to apply a driving force to the anchor to drive and push the at least one anchor into the flexible ring.

  A prosthetic valve may be delivered by the catheter to the implantation site and can be expanded when the flexible ring is folded for insertion into the catheter and pushed out of the distal end of the catheter. A prosthetic valve may be implanted at the implantation site and the driver may be configured to drive the anchor and at least partially through the ring and into the tissue surrounding the implantation site.

  The anchor includes a distal end tapered toward a distal tip configured to pierce tissue, a radially outer surface and a radially inner surface, proximal and radially from the distal end. At least one ridge extending outwardly to the free end, and a flexible stem extending proximally from the distal end, flexible to the at least one ridge and distal tip , May be provided. The flexible stem may be configured to flex in cooperation with a force applied to the anchor. The at least one anchor may be configured to engage tissue and resist proximal movement.

  The driver may be configured to rotate about the applicator shaft and may further be configured to index the drive of the anchor along each spring arm.

  Proximal to the applicator shaft to apply a distally directed force to the applicator shaft to release the spring arm from engagement with the flexible ring and to pull the applicator proximally through the prosthetic valve By applying a lateral force, the applicator can be removed from the prosthetic valve.

  The firing arm may be hinged to the driver at the proximal end of the firing arm, or it may be hinged to the driver at the distal end of the firing arm.

  According to a preferred embodiment of the present invention, the surgical device comprises a driver having a distal end and at least one firing arm, said at least one firing arm being hingedly connected to the distal end of the driver. At least one firing arm, each including at least one anchor outlet, having a retracted position parallel to the driver and a firing position in which the firing arm is directed proximally and radially outwardly, and disposed within the driver And a firing mechanism coupled to the guide configured to transmit force from the guide in a firing position proximal and radially outward of the firing arm.

  According to a preferred embodiment of the present invention, the surgical device is collapsible for insertion into a catheter and expandable upon ejection from the catheter, and the ring is juxtaposed with tissue. An applicator having one or more spring arms configured to exert a force on the ring and driving at least one anchor into the ring and tissue to secure the ring to the tissue. And a driver having at least one firing arm. The spring arm may be further configured to match the ring to the surrounding tissue contour. The spring arm may apply a force to the ring while the driver drives and pushes at least one anchor into the ring and tissue to secure the ring to the tissue.

  The surgical device may include an applicator shaft that passes through the ring and ends with one or more spring arms, the spring arm coupling the distal end of the applicator shaft to the ring, and the applicator shaft. A proximally directed force applied to the one or more spring arms and the flexible ring, and the firing arm may be hinged to the driver; It has a retracted position where the firing arm is parallel to the applicator shaft and a firing position where the firing arm is directed to the ring.

  The driver may include multiple firing arms, and the multiple firing arms may fire multiple anchors simultaneously.

  The firing position may be perpendicular to the applicator shaft. The firing position may be less than 90 degrees from the retracted position.

  The firing arm may be hinged to the driver at the proximal end of the firing arm, or it may be hinged to the driver at the distal end of the firing arm.

  Further features and aspects of the present invention are described in detail below with reference to the accompanying drawings.

FIG. 3 shows a heart valve replacement prosthesis, applicator shaft, spring arm, and driver, in accordance with a preferred embodiment of the present invention. FIG. 5 shows a heart valve replacement prosthesis, an applicator shaft, and a spring arm according to a preferred embodiment of the present invention. FIG. 3 shows a heart valve replacement prosthesis, applicator shaft, spring arm, and driver, in accordance with a preferred embodiment of the present invention. FIG. 3 shows a heart valve replacement prosthesis, applicator shaft, spring arm, and driver, in accordance with a preferred embodiment of the present invention. FIG. 3 shows a heart valve replacement prosthesis, applicator shaft, spring arm, and driver, in accordance with a preferred embodiment of the present invention. FIG. 3 shows a heart valve replacement prosthesis, applicator shaft, spring arm, and driver, in accordance with a preferred embodiment of the present invention. FIG. 3 shows a heart valve replacement prosthesis, applicator shaft, spring arm, and driver, in accordance with a preferred embodiment of the present invention. FIG. 3 shows a heart valve replacement prosthesis, applicator shaft, spring arm, and driver, in accordance with a preferred embodiment of the present invention. FIG. 3 shows a heart valve replacement prosthesis according to a preferred embodiment of the present invention. FIG. 3 shows a heart valve replacement prosthesis according to a preferred embodiment of the present invention. FIG. 3 shows an anchor according to a preferred embodiment of the present invention. FIG. 3 shows an anchor according to a preferred embodiment of the present invention. FIG. 3 shows a heart valve replacement prosthesis according to a preferred embodiment of the present invention. 1 is a cross-sectional view illustrating a driver for a heart valve replacement prosthesis according to a preferred embodiment of the present invention. FIG. 2 shows a heart valve replacement prosthesis driver according to a preferred embodiment of the present invention. 1 is a cross-sectional view illustrating a driver for a heart valve replacement prosthesis according to a preferred embodiment of the present invention. FIG. 2 shows a heart valve replacement prosthesis driver according to a preferred embodiment of the present invention. 1 is a cross-sectional view illustrating a driver for a heart valve replacement prosthesis according to a preferred embodiment of the present invention. FIG. 2 shows a heart valve replacement prosthesis driver according to a preferred embodiment of the present invention. 1 is a cross-sectional view illustrating a driver for a heart valve replacement prosthesis according to a preferred embodiment of the present invention.

  As shown in more detail below, preferred embodiments of the present invention enable reliable and effective delivery, implantation, and fixation of heart valve replacement prostheses so that the prosthesis can effectively address heart valve defects. It is like that.

  A preferred embodiment of the present invention is shown in FIG. FIG. 1 shows a heart valve replacement prosthesis 1 having a ring 10. The ring may be elastic in a preferred embodiment. FIG. 1 further shows an applicator 20 having an applicator shaft 21 and a spring arm 22. The spring arm 22 may be fixed to the distal end of the applicator shaft 21 and may couple the distal end of the applicator shaft 21 to the ring 10 of the replacement presthesis 1. FIG. 1 further shows a driver 40 as described in detail below.

  As generally seen from U.S. Pat. No. 7,621,948, which is hereby incorporated in its entirety as if fully disclosed herein by reference. The replacement prosthesis 1 of the present invention can be delivered to the implantation site by first crushing the replacement prosthesis 1 to a collapsed or folded position so that the prosthesis fits inside the catheter cavity. A catheter containing a collapsed or folded prosthesis is percutaneously advanced to the implantation site. Once the distal end of the catheter is adjacent to the implantation site, the collapsed prosthesis can be pushed or pushed through the distal end of the catheter.

  The heart valve replacement prosthesis 1 may be made of a compliant elastic material, such as deformable plastic or Nitinol, so that once the collapsed prosthesis exits the distal end of the catheter, the ring 10 is As shown at 10, it can elastically return to an uncollapsed or expanded configuration. The prosthesis 1 including the ring 10 may be manipulated within the implantation site and the prosthesis may be pushed into place within the implantation site.

  As further shown in FIGS. 1-10, in a preferred embodiment of the present invention, the ring 10 can assume the shape of an implantation site. This shape may be an irregular shape (eg, non-circular). In the preferred embodiment shown in FIGS. 1-10, the ring 10 is non-circular and irregularly shaped. Thus, the heart valve replacement prosthesis of the present invention can be adapted to a variety of implantation sites to address a variety of heart valve defects.

  As shown in FIG. 2, the heart valve prosthesis 1 further includes a leaflet 30. The leaflet performs a valve function. The leaflet 30 is coupled to the ring 10 and is held in place by a valve strut 31. The leaflet 30 is configured to block fluid in the first fluid flow direction and allow fluid flow in the second fluid flow direction.

  2-8 illustrate a preferred embodiment of securing the replacement prosthesis 1 to the tissue at the implantation site.

  As shown in FIG. 2, the replacement prosthesis 1 has been expanded from the catheter, and the ring 10 is almost completely in the expanded configuration. The applicator shaft 21 extends from the proximal direction to the distal side of the ring 10. The spring arm 22 is coupled to the distal side of the applicator shaft 21 so that the distal end of the applicator shaft 21 forms a conical apex formed by the spring arm 22 about the axis of the applicator shaft 21. It has become. Once delivered to the implantation site, the applicator shaft 21 can be used to push the ring 10 into the tissue at the implantation site by pulling the applicator shaft 21 proximally. In this case, a proximal force is transmitted to the spring arm 22, which in turn causes the spring arm 22 to apply a force proximally and radially to the ring 10. Since the spring arms include spring elements 23, such as springs or spring-like ribbons, each spring arm can bend to absorb force independently of the other spring arms. In this way, the ring 10 can also acquire an irregular shape and match the shape of any implanted tissue. Figures 2-8 show the various spring arms 22 being stretched or compressed to different degrees.

  As shown in FIG. 3, once the prosthesis 1 is in place at the implantation site, operating the driver 40 can tighten the ring 10 to the tissue at the implantation site. The driver 40 can be manipulated to slide along the applicator shaft 21 or to move in other ways. The guide 43 and the firing arm 41 may be disposed on opposite sides of the applicator shaft 21 as shown in FIG.

  As shown in FIG. 4, the driver 40 is moved to the distal end of the applicator shaft 21. At this location, the applicator 21 faces the spring arm 22.

  As shown in FIG. 5, the firing arm 41 rotates from a position aligned with an axis defined by the applicator shaft 21 to a position oriented radially away from the applicator shaft 21. The firing arm anchor outlet 42 is directed to the ring 10.

  As shown in FIG. 6, firing arm 41 may be configured to drive anchor 50 through anchor outlet 42. The anchor 50 can be driven and pushed through the ring 10 into the surrounding tissue at the implantation location to secure or tighten the ring 10 to the surrounding tissue at the implantation location.

  As shown in FIG. 7, once the anchor 50 is driven and pushed into the ring 10 and surrounding tissue, the firing arm 41 is rotated to align with the axis defined by the applicator shaft 21. So that the driver 40 can be retracted from the distal end of the applicator 20, as shown in FIG.

  In the preferred embodiment of the present invention, the driving of the anchor 50 can be repeated by the driver 40 and the firing arm 41 to drive the anchor 50 around the ring 10. Multiple anchors 50 may be loaded into the anchor cartridge or tray so that additional anchors can be loaded into position to be driven and pushed into the ring 10 and surrounding tissue. The driver 40 can determine the drive of each anchor 50 corresponding to the position of each spring arm 22 around the ring 10. In another embodiment, the applicator shaft 21 may have a groove or other marking, and the driver 40 can determine the drive of each anchor 50 in response to the groove or other marking.

  As shown in FIG. 9, the heart valve replacement prosthesis 1 is shown alone, with no applicator 20, driver 40, or anchor 50 present.

  FIG. 10 shows heart valve replacement after the driver 40 has completed driving the plurality of anchors 50 around the ring 10 and after the applicator 20 including the applicator shaft 21 and spring arm 22 has been retracted. The prosthesis 1 is shown. To retract applicator 20, applicator shaft 21 is moved distally, spring arm 22 is further extended beyond the distal side of ring 10, and the conical structure formed by spring arm 22 is collapsed. It may be possible to do. Once crushed, the spring arm 22 can retract the applicator shaft 21 and pass through the ring 10 so that the entire applicator 20 can be retracted from the implantation site.

  The anchor 50 includes US Provisional Patent Application No. 61 / 296,868 filed on January 20, 2010, and US Patent Application No. 13 / 010,766 filed on January 20, 2011. No. 13 / 828,256 filed on Mar. 14, 2013, U.S. Patent Application No. 13 / 843,930 filed on Mar. 15, 2013 , US patent application Ser. No. 14 / 301,106, filed Jun. 10, 2014, and any of the anchors. Each of the above specifications is hereby incorporated by reference in its entirety as if fully set forth herein.

  For example, FIG. 11 shows an anchor or implant 200. Anchor or implant 200 is configured to be driven and pushed into tissue. The anchor 200 includes a bowl-shaped body 201. The body 201 includes a groove 203 that extends in the axial direction along the length of the body 201. As described above, the plurality of grooves 203 and the plurality of flanges 205 alternately extend in the circumferential direction of the body 201. Furthermore, the anchor body 201 includes a pair of wing-like parts or divided parts 207 and 208. The dividing parts 207 and 208 are formed by respective tears or cuts 209 made in the body 201. In this regard, the split 209 may be formed by forming a cut radially in the body 201 and extending it axially. Thus, the two splits 207 and 208 are attached to the rest of the body 201 at a distal location and extend proximally to the free end. The free end includes a plurality of sharp protrusions along the curved surface. These tips are formed on the basis of the wrinkles. Specifically, as shown in the insertion partial side view of FIG. 11, the collar 205 forms a sharp protrusion. These protrusions are advantageous for grasping tissue and preventing the distal slide of anchor 200. Although each split 207 and 208 includes three such protrusions as shown, it should be understood that anchor 200 is one or more of the splits with a single sharp protrusion. It may be configured to have any other number of protrusions including. For example, if a greater number of sharp protrusions are desired, a denser ridge can be applied to the body 201 (ie, the number of alternating grooves 203 and ridges 205 can be increased), and It is also possible to adjust the angle of the cut or slice. Further, by changing the depth of the groove 203 relative to the ridge 205, the length of the protrusion extending proximally can be adjusted.

  Splits 207 and 208 do not significantly prevent distal insertion into the tissue, but resist movement from the insertion site to the proximal side by engaging the tissue. It has been found that the combination of proximal ends having the sharp edges and / or sharp edges of the splits 207 and 208 and the scissors provided alternately at the proximal ends of the splits improves performance.

  Furthermore, the split or wings 207 and 208 are offset from one another in the axial direction. For example, the dividing unit 207 is arranged at a position along the axis xx in the axial direction, and the dividing unit 208 is arranged at a position b along the axis xx in the axial direction. This allows for greater structural strength of the other parts of the body 201 compared to the unshifted configuration. Specifically, the cuts continue to move radially inward continuously as they travel distally, so that in an unshifted configuration, the portion is cross-sectional at the distal end of the cut. The amount of material is significantly reduced. This leads to mechanically weak points or regions along the body axis, which can lead to mechanical defects, especially in the case of small sized anchors. The anchor 200 utilizes a pair of wings 207 and 208 to secure the anchor 200 to resist proximal withdrawal from the tissue, but it should be appreciated that there are any number of wings. Alternatively, or in addition to wings 207 and 208, any other suitable anchoring structure, such as anchoring filaments, may be provided.

  The distal tip of the anchor 200 is in the shape of a pyramid and has a sharp tip and a plurality of faces separated by edges that converge at the sharp tip. Although four flat surfaces are provided, it will be appreciated that any suitable number of surfaces may be provided, and one or more or all of the surfaces may not be flat.

  Anchor 200 may include one or more shoulders. The shoulder is formed by the junction of the wings 207 and 208 and the body 201, or the wings 207 and 208 extend proximally and radially outward from the distal end, or farther than the distal end. Defined by the area of anchor 200 on the distal side. As shown in FIG. 11, the wings 207, 208 have a relaxed uncompressed position, but can be compressed to a second compressed position closer to the body. Further, the body 201 may be flexible so that forces received within the proximal end affect the position of the wings 207 and 208 and the body or stem 201 relative to the distal end. be able to.

  The anchor 200 first forms a body 201 with ridges, for example by injection molding or extrusion, and subsequently forms splits 207 and 208 by, for example, making radial cuts in the sides of the body 201. May be manufactured by. As shown, the notch is curved with the angle relative to the longitudinal axis xx of the body 201 (at the proximal entry point) gradually decreasing from the proximal initial cutting location toward the distal end of the anchor 200. And eventually it becomes linear. The segment or incision in the illustrated example is formed to have a curved or changing angle with respect to the longitudinal axis direction xx of the body 201, but of course any suitable incision including a linear incision. May be formed.

  The anchor 200 includes two wings or divisions spaced evenly around the radial circumference of the body 201, but of course any number of divisions including a single division. The portions may be provided at any suitable interval around the radial circumference of the anchor 200.

  Current manufacturing methods enable the application of near nanotechnology. This allows the anchor 200 to be manufactured with a size and complexity that was not possible in the past. Anchor 200 may be injection molded from an absorbent or non-absorbable polymer and then processed to add the features of wings 207 and 208 (eg, by cutting). Although anchor 200 is formed from a polymer, any suitable material, such as a metal or composite material, may be used. Anchor 200 may have a diameter of, for example, 1 millimeter, or approximately 1 millimeter, and a length of, for example, 5 millimeters to 10 millimeters. According to some preferred embodiments, the diameter is less than 1 millimeter. According to some preferred embodiments, the diameter is between 0.8 millimeters and less than 1.2 millimeters. However, it will be appreciated that other dimensions may be provided.

  In a preferred embodiment of the present invention, the anchor 4200 shown in FIG. 12 will be described. Anchor 4200 includes a distal tip 4230 and a stem 4201 extending proximally from the base of distal tip 4230. Stem 4201 is joined to the base of distal tip 4230 at shoulder 4240. Wings or ridges 4207, 4208 extend proximally and to some extent radially from the base of the distal tip 4230, and are joined to the base of the distal tip 4230 by a shoulder 4240. The hooks 4207, 4208 extend from the distal tip 4230 proximally and radially to the free end. As shown in FIG. 12, the free end may further flared outward in the radial direction. Unlike the wings or hooks 207, 208 described above, the wings or hooks 4207, 4208 are not formed from cuts or splits made in the body of the anchor, so the thickness of the stem 4201 is Inclusion of hooks 4207, 4208 is not affected. Wings or ridges 4207, 4208 may have a relaxed, uncompressed position as shown in FIG. In the non-compressed position, the hooks 4207 and 4208 are not biased and have a hook-like opening W. The flanges 4207 and 4208 can be brought closer to the stem 4201 by being compressed. Various amounts of compression can be applied to the collar, so that the greater the compression, the closer the collar is to the stem. The ridges 4207, 4208 can include a protrusion at the free end of the ridge so that the anchor can be engaged once tissue is deployed. Although two hooks 4207, 4208 are shown, it will be appreciated that any number of hooks may be provided. Similarly, any number of protrusions may be provided at the free end of the saddle, including one sharp protrusion.

  Stem 4201 can be flexible and can be bent or deflected relative to saddles 4207, 4208 and distal tip 4230. Once deployed into the tissue, the flexible stem provides a different force profile acting on the anchor 4200 compared to an anchor having a rigid or unbent stem. A flexible shaft that can be deflected relative to the hook and distal tip forms a living hinge between these elements of the anchor. Forces acting on the anchor from its proximal end can be absorbed at least in part by the flexible stem, thus reducing the effects of these forces applied to the anchor's wings or hooks. . In a given tissue environment, the flexible shaft can increase the likelihood of blocking anchoring by the anchor and thereby prevent the anchor from being partially or completely pulled out of the tissue.

  Further, the anchors 50, 200 and 4200 are disclosed in US Provisional Patent Application No. 61 / 296,868 filed on January 20, 2010, and in US Patent Application No. 61 / 296,868 filed on January 20, 2011. Any of the features of fasteners or other similar implants disclosed in 13 / 010,766 and US patent application Ser. No. 14 / 301,106 filed Jun. 10, 2014. And may be driven using any mechanism disclosed in the above specification. Each of the above specifications is hereby incorporated by reference in its entirety as if fully set forth herein.

  A force delivery system is disposed at the proximal end of the driver for firing the anchor. The force delivery system may use any mechanism of near instantaneous force transmission, such as a spring, gas, compressed fluid, or the like. It is transmitted through the driver shaft. The shaft may be a rigid shaft or a flexible shaft, depending on the application. The force is used to displace the firing mechanism at the distal end of the shaft, which drives the anchor from the firing arm and pushes it into the prosthetic valve and surrounding tissue by applying a driving force to the anchor. Depending on the application, the driving force may result from a push force delivery system that directs the force in the distal direction of the driver, or a tensile force delivery system that directs the force in the proximal direction of the driver.

  In a preferred embodiment of the present invention, a plurality of firing arms may be provided around the applicator, as shown in FIGS. The driver 60 shown in FIGS. 13 and 14 has a plurality of firing arms 61 at the distal end arranged annularly around a tubular guide 63. Guide 63 may enclose the applicator shaft in much the same way as guide 43. The firing arm 61 is in a retracted position with respect to the driver and is parallel to the driver axis. FIG. 14 also shows an anchor 4200 provided in the firing arm 61. A window 64 allows the ridges 4207, 4208 to be stored in the firing arm 61 in a relaxed position before being driven from the anchor outlet and pushed into the ring 10 and surrounding tissue.

  15 and 16 show the drive 60 with the firing arm moved from the retracted position to the firing position. Movement of the firing arm from the retracted position of FIGS. 13 and 14 to the firing position of FIGS. 15 and 16 can be accomplished by manually or electrically moving the force, eg, by a screw or sliding mechanism, or by any other mechanical operation. Can be achieved by operating. Since firing arm 61 is hinged to driver 60 at the distal end of the driver, firing arm 61 opens radially outward from a position proximal to the distal end of the hinge and driver 60. The firing position of the firing arm may be at an angle of less than 90 degrees from the axis of the driver 60. The acute angle of the firing arm 61 allows for angled anchor delivery into the ring 10 and surrounding tissue, and thus allows for greater control of anchor placement within the surrounding tissue.

  As shown in FIG. 16, firing arm 61 includes firing mechanism 65 and finger 66 to drive anchor 4200 through anchor outlet 62. Since the guide 63 is coupled to the firing mechanism 65 and the finger 66, when a force directed to the proximal side or a pulling force is applied to the guide, the force acting in the proximal direction is moved to the firing mechanism 65 and the finger 66. It will be. Finger 66 abuts shoulder 4240 of anchor 4200 and can be transmitted from firing mechanism 65 and finger 66 to anchor 4200.

  17, 18, 19, 20 show the firing of the anchor 4200. Anchor 4200 is fired by applying a proximally directed or pulling force and pulls guide 63 proximally relative to driver 60. 17 and 18, the guide 63 is attracted to approximately the same height as the hinged end of the firing arm 61, and as shown in FIGS. 61 is attracted to the embedded position relative to the hinged end. A proximally directed force that attracts the guide 63 is transmitted to the firing mechanism 65 and to the finger 66. Finger 66 then transmits a driving force to shoulder 4240 of anchor 4200, driving anchor 4200 through anchor outlet 62 and pushing it into ring 10 and surrounding tissue. Thus, all of the firing arms 61 can fire the anchor 4200 simultaneously.

  Further, the implantable elements described herein, such as the anchors 50, 200, 4200, and any other elements of the ring 10, leaflet 30, valve strut 31, or heart valve replacement prosthesis 1 are, for example, specific Depending on the application, it may be formed in whole or in part from materials that can be absorbed into the patient's body or from non-absorbable materials. For example, these elements may be formed from polyglycolic acid (PGA) or PGA copolymers. These elements may additionally or alternatively be formed from polyester and / or nylon and / or copolymers of other polymers. In addition, these elements may contain one or more shape memory alloys, such as Nitinol, spring loaded steel, or other alloys or materials with suitable properties.

  Absorbable materials are advantageous when there is a potential for misfire or improper placement of various implants. For example, in situations where the driver drives the anchor 50, 200, 4200 at an unintended location, or in situations where the tissue does not properly receive the anchor 50, 200, 4200, the anchor 50, 200, 4200 may not be required. Eventually it is absorbed into the patient's body and is therefore relatively harmless.

  Exemplary heart valve replacement prosthesis systems have been described above, but the systems and devices described herein are in no way limited to these examples.

  Although the invention has been described with reference to specific examples and preferred embodiments, it is to be understood that the description is in no way limiting. Furthermore, the features described herein can be used in any combination.

Claims (21)

A prosthetic valve device having a flexible ring;
An applicator having an applicator shaft that terminates at a distal end having one or more spring arms through the ring and applied to the applicator shaft; The spring arm couples the distal end of the applicator shaft to the ring so that a force directed toward the distal side is transmitted to the one or more spring arms and the flexible ring. With an applicator,
A driver having a guide annularly disposed about the applicator shaft and at least one firing arm including at least one anchor outlet, wherein the driver has a proximal position; A driver configured to slide along the applicator shaft to and from a distal position;
With
In the proximal position of the driver, the at least one anchor outlet is disposed parallel to the applicator shaft, and in the distal position of the driver, the at least one anchor outlet is directed to the flexible ring, The at least one firing arm is hingedly connected to the driver, and the driver applies a driving force to the anchor to drive and push the at least one anchor into the flexible ring. Formed,
Surgical equipment.   2. The prosthetic valve is delivered by a catheter to an implantation site, the flexible ring is folded for insertion into the catheter and can be expanded when pushed out of the distal end of the catheter. The surgical device as described.   The prosthetic valve is implanted at an implantation site, and the driver is configured to drive the anchor and at least partially through the ring and into the tissue surrounding the implantation site. The surgical device as described. The at least one anchor is
A distal end tapered toward a distal tip configured to puncture tissue;
At least one ridge extending from the distal end proximally and radially outward to a free end, comprising a radially outer surface and a radially inner surface;
A flexible stem extending proximally from the distal end, flexible to the at least one saddle and distal tip;
The surgical apparatus according to claim 1, comprising:   The surgical apparatus according to claim 5, wherein the flexible stem is configured to flex in cooperation with a force applied to the anchor.   The surgical apparatus according to claim 1, wherein the at least one anchor is configured to engage tissue and resist proximal movement.   The surgical apparatus according to claim 1, wherein the driver is configured to rotate about the applicator shaft.   The surgical apparatus according to claim 7, wherein the driver is configured to index the drive of the anchor along each spring arm.   Applying a distally directed force to the applicator shaft to release the spring arm from engagement with the flexible ring, and pulling the applicator proximally through the prosthetic valve The surgical apparatus according to claim 1, wherein the applicator can be removed from the prosthetic valve by applying a proximally directed force to the applicator shaft.   The surgical apparatus according to claim 1, wherein the firing arm is hinged to the driver at a proximal end of the firing arm.   The surgical apparatus according to claim 1, wherein the firing arm is hinged to the driver at a distal end of the firing arm. A driver having a distal end;
At least one firing arm, the at least one firing arm hingedly connected to the distal end of the driver, each including at least one anchor outlet, and a retracted position parallel to the driver; At least one firing arm having a firing position in which the firing arm is directed proximally and radially outward;
A guide disposed inside the driver;
A surgical mechanism coupled to the guide configured to transmit a force from the guide in a direction proximal and radially outward of the firing arm at the firing position. . A flexible ring that is collapsible for insertion into a catheter and expandable upon ejection from the catheter;
An applicator having one or more spring arms configured to exert a force on the ring such that the ring is juxtaposed with tissue;
A driver having at least one firing arm configured to drive and push at least one anchor into the tissue to secure the ring to the tissue;
A surgical device comprising:   The surgical apparatus according to claim 13, wherein the spring arm is further configured to conform the ring to a surrounding tissue contour.   The surgical of claim 13, wherein the spring arm applies a force to the ring while the driver drives and pushes at least one anchor into the ring and the tissue to secure the ring to the tissue. apparatus. further,
An applicator shaft passing through the ring and ending with the one or more spring arms, the spring arm coupling a distal end of the applicator shaft to the ring, the applicator shaft A proximally directed force applied to the one or more spring arms and the flexible ring;
The firing arm is hingedly connected to the driver and has a retracted position in which the firing arm is parallel to the applicator shaft and a firing position in which the firing arm is directed to the ring;
The surgical apparatus according to claim 13.   The surgical apparatus according to claim 15, wherein the driver includes a plurality of firing arms and the plurality of firing arms fires a plurality of anchors simultaneously.   The surgical apparatus according to claim 15, wherein the firing position is perpendicular to the applicator shaft.   The surgical apparatus according to claim 15, wherein the firing position is less than 90 degrees from the retracted position.   The surgical apparatus according to claim 15, wherein the firing arm is hinged to the driver at a proximal end of the firing arm.   The surgical apparatus according to claim 15, wherein the firing arm is hinged to the driver at a distal end of the firing arm.

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