JP6118894B2 - Inverted transfer device and method for prosthesis - Google Patents

Description

Related applications

  This application claims priority from US Provisional Application No. 61 / 486,682, filed May 16, 2011, entitled “Prosthetic Reverse Transfer Device and Method”. A continuation-in-part application having US patent application Ser. No. 13 / 473,475 filed May 16, 2012 entitled “Method”. The entire application is incorporated herein by reference.

Background of the Invention

  Significant progress has been made in the development and treatment of cardiovascular surgery using a percutaneous approach. For example, one or more catheters introduced through the femoral artery are used to transfer instruments and elements to the desired area within the cardiovascular system, thereby allowing many complex procedures that would normally require invasive surgical procedures. A procedure can be performed. Such an approach can greatly reduce the trauma that the patient will withstand and significantly shorten the recovery period. The percutaneous approach is particularly attractive as an alternative to open-heart surgery.

  Valve replacement is an example of an area where percutaneous solutions are under development. Many diseases cause heart valve leaflet thickening and subsequent paralysis or hypoactivity. Such a paralyzed state may lead to narrowing or narrowing of the passage through the valve. Increased blood flow resistance due to stenotic valves can ultimately lead to heart failure and ultimately death.

  In the treatment of valve stenosis or regurgitation, a prosthetic valve was transplanted after the patient's existing valve was completely removed by an open-heart procedure. Of course, this is a very invasive surgery, which can cause major trauma to the body and usually requires a great deal of pain and considerable recovery time. It is also an advanced operation that requires abundant expertise and surgical skills.

  Historically, such valve replacements have been performed using conventional open heart surgery, open the chest, stop the heart, provide the patient with cardiopulmonary bypass, resect the patient's native valve, A replacement valve was installed. On the other hand, a proposal for an alternative percutaneous valve replacement method is disclosed in US Pat. No. 6,168,614 issued to Andersen et al., The entire contents of which are incorporated herein by reference. In that patent, the prosthetic valve is mounted on a stent that is crushed to a size that fits inside the catheter. The catheter is then inserted into the patient's vasculature and the collapsed stent is moved into place at the patient's native valve. The deployment mechanism is activated to expand the stent containing the replacement valve against the valve leaflets. The expanded structure houses a stent configured to have a valve shape at the leaflet support and initiates the take over of the patient's native valve function. As a result, replacement of the entire valve is achieved, and the physical impact on the patient is much lower.

  However, this approach has decisive drawbacks. One particular drawback associated with the percutaneous approach disclosed in the Andersen 614 patent is that it is difficult to prevent leakage from the periphery of the new valve after implantation. Since the patient's native valve tissue remains in the lumen, it may be difficult to seal around the prosthetic valve due to commissural joints and fusion points of the valve tissue (push open and secured by the stent) high. As a result, in many cases, in practice, leakage of blood around the stent device has become serious.

  Another shortcoming of the Andersen 614 patent approach relates to its reliability relative to a stent as a support scaffold for a prosthetic valve. First, stents can emboli when expanded. Secondly, stents typically cannot effectively capture emboli that have peeled off during or after deployment. Thirdly, stents typically do not conform to the patient's native lumen shape in which the stent is placed, leading to paravalvular leakage of the prosthetic valve stored within the stent. Fourth, stents are exposed to a trade-off between strength and compressibility. Fifth, the stent is not recoverable after deployment. Sixth, stents are inherent in strength and cannot be adjusted.

  With regard to the first drawback, stents are usually classified into one of two categories: self-expanding stents and balloon expandable stents. A self-expanding stent is compressed when loaded into a catheter and expands to its original uncompressed size when removed from the catheter. Self-expanding stents are typically made of nitinol. Balloon expandable stents remain compressed and relaxed when loaded into a catheter. Balloon expandable stents are typically made from stainless steel or other malleable metals. The balloon is placed in the stent. When deployed, the catheter is retracted and the balloon is inflated, thereby expanding the stent to the desired size. Both of these types of stents generate significant forces when expanded. Such a force is strong enough to cause a crack or deformation at the thrombus site, causing the arteriosclerotic plaque fragments to peel off, leading to embolism. Such expansion is somewhat desirable when the stent is implanted for the treatment of vascular stenosis. However, if the stent is simply implanted instead of the patient's native valve, it may be desirable to reduce the force to reduce the chance of embolization. A further concern associated with aortic valve replacement is the risk of conduction disturbances (ie, left limbal blockage) due to the proximity of the conduction pathway to the patient's native valve tissue. Excessive radial force on the patient's native valve site increases inflammation or damage to the conduction pathway and the risk of heart block.

  With regard to the second drawback, when embolization occurs, the expanded stent cannot effectively capture peeled debris because the members are often too far apart. In many cases, secondary precautions need to be taken, such as the use of nets and irrigation ports.

  A third drawback is due to the relative inflexibility of the stent. Stents typically rely on the elastic nature of the patient's native blood vessel to conform to the stent geometry. Stents used to open narrow blood vessels do not require a seal between the blood vessels and the stent. However, when using a stent to install a prosthetic valve as an alternative to a patient's native valve, a seal between the stent and the blood vessel is necessary to prevent paravalvular leakage. Due to the incompatible nature of the stent, this seal is difficult to achieve, especially when it replaces a stenosed leaflet.

  The fourth drawback is a trade-off between compressibility and strength. Stents become stronger or larger when manufactured with thicker members. Therefore, high strength stents are not as compressible as low strength stents. Most stents suitable for use within the valve are not compressible enough to be placed in a thin catheter such as an 18 Fr catheter. Larger delivery catheters are more difficult to move to the target area and cause more trauma to the patient.

  A fifth drawback of stents is that they cannot be easily retrieved. The deployed stent may be inelastically deformed (stainless steel) or may require a radial force to maintain the stent in its original state (Nitinol). May not be able to place. Thus, if the physician is unhappy with the deployed position or orientation of the stent, there is little that can be done to correct this problem.

  The sixth drawback mentioned above is that the stent is not adjustable because it has inherent strength. As described above, a high-strength stent is made of a high-strength member. Once a stent is selected and deployed, there is little that a doctor can do even if the stent is found to be too strong or too low.

  Various embodiments of elements to solve these problems are introduced in US Patent Publication No. 2006/0271166, entitled “Stentless Support Structure,” which is incorporated herein in its entirety. This publication teaches a braided mesh tube that folds inward back and forth, which forms a support structure that is strong enough to hold the valve leaflets of the patient's native valve in place and allows the replacement valve to deploy normally. Thus, there is no need to resect the patient's native valve. Advantageously, because these elements are reversible, the braided mesh does not need to retain sufficient strength to replace the patient's native valve in the elongated transfer state until the reversal process occurs. As a result, the mesh tube can be configured so that it can be compressed into a very small catheter such as a catheter of 18 Fr or less in a long transfer state. Such a small catheter significantly reduces patient trauma and facilitates guidance within the percutaneous lumen through the blood vessel. Terms such as “transluminal” and “percutaneous” as used herein are explicitly defined as passing through the lumen of a blood vessel and axially to a target location, It should be understood that this is in contrast to surgically cutting the target vessel or performing open heart surgery to manually place the element. Further, the term “mesh” as used herein should be understood to mean a material composed of one or more braids or woven bundles.

  In order to achieve such a feature that the element is folded back and forth, the element is pre-formed with a crease at the periphery. In one embodiment, there are two circumferential creases spaced apart in the longitudinal direction in the stretched state. One of these folds is pre-formed to fold inward and the other is pre-formed to fold outward. These preformed folds tend to return to a folded state having a z-shaped cross-section when removed from the catheter. This cross-sectional design is not only because the inward pre-formed folds fold inward and the outward pre-formed folds fold outward, but these folds are positioned in the longitudinal direction once folded. This is because of inversion. When the inward preformed fold is distal to the outward preformed fold in the stretched state, the inward preformed fold is more proximal than the outward preformed fold in the folded state. According to this design, the valve at the distal end of the element can be retracted into the element when folded, without flipping or ablating the valve itself. Thus, in one embodiment with two pre-formed folds, the inversion process resulted in a three-layer configuration, which could be significantly shorter depending on the crease spacing compared to the stretched length.

  It has been found in the development of the element described in the aforementioned published document US 2006/0271166 that the axial direction of the outermost layer of the implant, sometimes using an additional element during layer inversion It was advantageous to maintain the position. Thus, the transfer device illustrated and described in US Patent Publication No. 2008/0082165 entitled Wilson et al. The transfer device has an expandable mesh region that, when axially compressed, expands outward to form a spherical or rounded structure with an increased radius. Further compression in the axial direction results in a flat disc-like surface. In use, the element is extended through the implant and then removed from the delivery catheter. The element is then expanded into a disk-like state and pulled proximally to act as a backstop at the desired target location for transferring the implant. In this way, the disc-shaped element prevents the implant from moving axially in the distal direction even when a distal force is applied to the implant when inverting the second or subsequent layer into the first layer. Yes.

  However, it is known that depending on the target location and the patient's anatomy, there may not be sufficient space for efficient use of the transfer device in the distal axial direction beyond the target location. For example, in some patients, the left ventricular space may be limited, which may prevent the use of backstop elements.

  Accordingly, there is a need for an element that can prevent axial movement of the braided implant element described above during reversal and that does not require a required space distally beyond the target location.

  The present invention satisfies the aforementioned needs by providing a transfer device that holds the braided implant in the desired location when inverting the subsequent layer to the first layer. More specifically, the present invention relates to a transfer device that is releasably attached at or near a first fold position (hereinafter referred to as “aortic flare”), which is a hinge point where the inversion of the implant used in the present invention occurs. I will provide a.

  By attaching to the aortic flare, the delivery device of the present invention allows for precise placement and inversion by limiting the advancement of a portion of the implant while continuing to advance the rest of the device. Thus, the reversal is performed at a location selected by the practitioner regardless of the patient's anatomy or placement obstacles. One embodiment of the present invention achieves this high precision placement by attachment to the distal end of the transfer device.

  Two aspects of the present invention provide reliable performance of the transfer device of the present invention. The first aspect is an attachment mechanism that can be mounted on a braided element without significantly modifying the function of the braided element. This attachment mechanism stabilizes the element during the support structure inversion process. This attachment mechanism, in some embodiments, provides both attachment and release functions to the device. The second aspect of the present invention includes an arrangement mechanism that prevents movement of the element at the target location during the inversion process.

  According to another aspect of the present invention, when the element is deployed, the support structure anchor is given a degree of freedom of movement, but the anchor locking mechanism is automatically activated when the element advances to a position suitable for the inversion process. Such automatic actuation reduces the need for the physician to be involved or determined in the tension and setting of the anchor mechanism. Since the characteristics of this mechanism also take into account manufacturing tolerances and usage tolerances, the anchor locking mechanism can be adjusted with high accuracy in accordance with the selected valve and transfer system.

  The deployment device provided by yet another aspect of the present invention can place, implant and deploy the valve so that the valve is released after the prosthetic valve is fully functioning. Before the valve is released, it can be observed and confirmed that the valve is functioning normally. If the valve is not functioning as intended, the entire element can be quickly pulled back into the transfer device. In some situations, the valve can be repositioned and redeployed.

  According to still another aspect of the present invention, a transfer device is provided that houses a limiter that can be set before or during an operation. This limiter prevents the braided implant from exiting the transfer device beyond the desired degree prior to reversal.

FIG. 4 is a partial cross-sectional view of an embodiment in which the distal end of the transfer device of the present invention is loaded with an implant. FIG. 3 is a perspective view of an embodiment of the distal end of the pusher catheter of the present invention. Fig. 2b is a perspective view of a distal end embodiment different from the embodiment of Fig. 2a. FIG. 7 is a perspective view of the distal end embodiment of the release mechanism of the present invention in an open state. FIG. 4 is a perspective view of the mechanism of FIG. 3 in a closed state. These are top sectional drawings in front of the inversion process of an implant in embodiment of the transfer apparatus of this invention. FIG. 2 is a cross-sectional plan view immediately after inversion of the implant in the embodiment of the transfer device as shown in FIG. FIG. 6 is a perspective view of an embodiment of a pusher catheter of a transfer device. FIG. 6 is a perspective view of an embodiment of a pusher catheter of a transfer device. FIG. 6 is a perspective view of an embodiment of a pusher catheter of a transfer device. FIG. 6 is a perspective view of an embodiment of a pusher catheter of a transfer device. FIG. 3 is a plan view of an embodiment of the handle assembly of the present invention. These are the exploded views of embodiment of the valve holding cable operation part of this invention. These are the perspective views in the closed position of embodiment of the valve holding cable operation part of this invention. These are the perspective views in the open position of embodiment of the valve holding cable operation part of this invention. FIG. 4 is a partial perspective view of an embodiment of the handle assembly of the present invention showing an embodiment of a pusher catheter operating portion. FIG. 5 is a partial perspective view of the handle assembly of the present invention showing an embodiment of a drive mechanism. These are the perspective views of embodiment in case the tether release operation part of this invention exists in a closed position. These are the perspective views of embodiment in case the tether release operation part of this invention exists in an open position. These are exploded views of an embodiment of the tether placement mechanism of the present invention. These are the perspective views of embodiment in case the tether arrangement | positioning mechanism of this invention exists in a latching position. These are the perspective views of embodiment in case the tether arrangement | positioning mechanism of this invention exists in a cancellation | release position. FIG. 6 is a side view of an embodiment when the transfer device of the present invention is in a patient's blood vessel. FIG. 23 is a side view of the embodiment immediately after the transfer device as shown in FIG. 22 has passed through the heart valve. FIG. 23 is a side view of an embodiment in which the implant is partially deployed by the transfer device as shown in FIG. 22. FIG. 23 is a side view of an embodiment in which a tether is tightened by a transfer device as shown in FIG. 22. FIG. 23 is a side view of an embodiment immediately after inversion of the implant with the transfer device as shown in FIG. FIG. 23 is a side view of the embodiment immediately after the tether is released from the implant and retracted with the transfer device as shown in FIG. 22. FIG. 23 is a side view of an embodiment of the transfer device as shown in FIG. 22 immediately before the mounting cable is released. FIG. 4 is a side view of the embodiment immediately after the release of the implant attachment cable.

Detailed Description of the Invention

  Referring now to the drawings and referring first to FIG. 1, the distal end of the transfer device 10 of the present invention is illustrated. This transfer device generally includes a transfer catheter 20 and a pusher catheter 30 slidably provided in the transfer catheter 20. The pusher catheter 30 is preferably a multi-lumen catheter, and three valve holding cables 40 (hereinafter “valve holding cables”) (see FIG. 3) are slidably housed to maintain their alignment. Including the lumen. A releasable gripping mechanism 50 is provided at each distal end of the valve retaining cable 40. The transfer device 10 also includes at least one deployment mechanism 60, which is used to help the instrument or implant 1 achieve a collapsed deployed state from the extended and extended guided state. In one embodiment, at least one deployment mechanism 60 is attached to the distal end of delivery catheter 20. In another embodiment, at least one deployment mechanism 60 is slidably housed within transfer catheter 20, similar to valve retention cable 40.

  Delivery catheter 20 is an outer sheath that defines a single lumen for storing pusher catheter 30, instrument or implant 1, valve retention cable 40, and deployment mechanism 60. When loaded, the delivery catheter 20 houses the instrument or implant 1 in the vicinity of its distal end 22. Implant 1 is preferably an implant similar to that taught and described in US Patent Publication No. 2006/0271166. The delivery catheter 20 may have a distal end formed with a predetermined curve. A positive result was obtained when the predetermined curve was 180 degrees.

  The pusher catheter 30 can accommodate up to seven lumens. Three lumens slidably store three valve retention cables 40. In embodiments that use over-the-wire, the fourth lumen houses the guide wire. In yet another embodiment, three additional lumens slidably store three placement mechanisms described below.

  Figures 2a and 2b show two similar embodiments defining seven lumens with the pusher catheter 30 of the present invention. The pusher catheter 30 includes a central guidewire lumen 32 and three lumens 34 that house the valve retention cable 40 or placement mechanism described below. The remaining three lumens 36 store the remaining attachment cables or placement mechanisms. To save space, the lumen 36 may be formed as an external recess, thereby forming a lumen in conjunction with the inner wall of the transfer catheter 20 to accommodate the remaining valve mounting cable or deployment mechanism. In the preferred embodiment, lumen 34 houses valve retention cable 40 and lumen 36 houses placement mechanism 60. In such an embodiment, the pusher catheter 30 can continue to advance even if the placement mechanism 60 cannot advance.

  In one embodiment, the deployment mechanism is sized small enough to accommodate three valve retention mechanisms and corresponding storage sheaths within a single lumen 36, while the other two lumens 36 are not yet open. It can be used as it is, that is, as an irrigation route.

  The releasable gripping mechanism 50 may be similar to that shown and described in U.S. Patent Application Publication No. 2008/0082165 (FIGS. 5-8). Another embodiment of a releasable gripping mechanism is shown in FIGS. The gripping mechanism 50 is attached to the commissure point on the implant 1 when the device 10 is loaded. The grasping mechanism 50 has a function to do so when it is determined that it is appropriate for the doctor to retract the implant into the apparatus 10.

  FIG. 3 shows the gripping mechanism 50 in the open state. The gripping mechanism 50 includes a hook 52 that slides in the mouth portion 54. The hook 52 defines a recess 56 that is sized to accommodate a commissure point or braid of the instrument or implant 1. The mouth 54 defines a slot 58 that is also sized to receive a component. FIG. 4 shows that when the gripping mechanism 50 is in the closed state, the recess 56 and the slot 58 together define a passageway 59 that captures the component therein.

  The gripping mechanism 50 is attached to the distal end of the valve holding cable 40. The valve holding cable 40 includes a wire 42 attached to the hook 52 and an elastomer sheath 44 attached to the mouth 54. The wire 42 and the hook 52 are slidably accommodated in the sheath 44 and the mouth portion 54. The sheath 44 is an elastomer that is compressible in the longitudinal direction. This feature prevents accidental release of the instrument or component contained within the passageway 59. For example, when retracting the instrument or implant, when pulling back into the transfer sheath 20, the wire 42 is loaded and the wire stretches. If the sheath 44 is not compressed, the wire 42 will stretch so that the hook 52 exits the mouth 54 and will then be in the open state of FIG. However, since the sheath 44 is compressed when pulled into the mouth 54 when the hook 52 is closed, the sheath 44 expands as the wire 42 extends, thereby maintaining the closed state of FIG.

  The placement mechanism 60 assists in reversing the instrument or component 1. In one embodiment shown in FIGS. 1, 5, and 6, the deployment mechanism 60 connects the delivery catheter 20 with a first inverted prefold point (also referred to herein as “aortic flare”) of the implant 1. doing.

  The placement mechanism 60 may include a plurality of tethers 62 and connectors 64. The tether 62 may be any elastic bundle material that is flexible enough to flip from the guided state to the deployed state. In the guided state, the tether extends proximally from the distal end of the transfer catheter 20 to the connector 64, as shown in FIG. 5 and 6, the tether 62 extends distally from the distal end of the transfer catheter 20 to the connector 64. In one embodiment, the connector 64 can grip any individual braid or bundle of the implant 1. In another embodiment, the connector 64 is designed to grip the intersection of two braids or bundles. In yet another embodiment, the connector 64 can grip separate attachment points (eg, wire loops, sutures, etc.) incorporated within the mesh implant or instrument 1. The length of the tether 62 is at least the length of the material of the implant 1 that extends distal to the connector 64 when the implant 1 is loaded into the delivery catheter 20. In this way, the implant 1 is completely held in the transfer catheter 20 in the guided state.

  In another embodiment, the deployment mechanism 60 is similar in structure to the valve retention cable 40 and the releasable gripping mechanism 50. However, since the placement mechanism 60 has lower strength requirements than the valve retaining cable 40 and its releasable gripping mechanism 50, the placement mechanism 60 has a smaller diameter, and thus the entire transfer device 10 can be made smaller. The arrangement mechanism 60 of the present embodiment is slidably accommodated in the lumen 36 of the pusher catheter 30 shown in FIG. 2 instead of being attached to the distal end of the transfer catheter 20 as described above.

  With reference to FIGS. 5 and 6, the device 10 is designed to be able to pass along a guide wire 70 during guidance. The conical or tapered dilator tip 80 abuts and is coplanar with the distal end 22 of the transfer catheter 20. The dilator 80 allows the device 10 to pass through the vasculature with minimal trauma. Since the dilator 80 is not physically attached to the transfer catheter 20, it is easily moved distally during the transfer of the implant 1 so as not to interfere with the deployment of the implant 1.

  Having described the various components of the present invention, the steps and conditions that occur during the guidance and deployment of the implant can now be described. FIG. 1 shows the guidance state of the device 10. In the guided state, the implant 1 is loaded at the distal end of the transfer catheter 20 so that the implant 1 is in an elongated unfolded state. The pusher catheter 30 is placed in the delivery catheter 20 with its distal end 22 proximal to the implant 1. The valve retention cable 40 extends distally from the pusher catheter 30 and is connected to the commissural point of the implant 1 by a releasable gripping mechanism 50. The conical dilator 80 abuts the distal end 22 of the transfer catheter 20. Upon guiding, the device 10 and the entire implant 1 travel along the guide wire 70 to the target location.

  FIG. 5 shows the initial stage of deployment of the implant 1. When the target location is reached, the transfer catheter 20 is retracted, while the pusher catheter 30 and the valve retaining cable (40) remain stationary relative to the target position. When the transfer catheter 20 is retracted, the pusher catheter 30 pushes the implant 1 out of the distal end 22 of the transfer catheter. When the implant 1 is withdrawn from the transfer catheter 20, the implant 1 expands and the placement mechanism 60 is placed until the tether 62 is tensioned or in the case of a placement mechanism slidably housed within the lumen of the pusher catheter 30. Advance through the transfer catheter 20 until the mechanism 60 can no longer advance.

  As can be seen from FIG. 6, when the pusher catheter 30 is further advanced, the implant material proximal to the connector 64 is flipped into the implant material distal to the connector 64. This is because the placement mechanism 60 is tensioned to prevent the implant 1 from being advanced further distally. Thus, the inversion of the implant 1 is performed by a fold formed in the implant, development of the shape memory metal constituting the implant 1, and restraint by the arrangement mechanism 60. It should be noted that the transfer of the implant from initial advancement to inversion is automatic and depends on the length of the tether 64. Thus, no practitioner's experience is required to start reversal. There is no reliance on the anatomical structure of friction against the implant to initiate reversal.

  When the implant 1 is fully deployed, the implant 1 functions well before release. This allows the proper operation of the implant 1 to be confirmed using one or more imaging schemes until the implant 1 is fully released. If proper operation is not achieved, the gripping mechanism 50 can be used to pull the implant 1 back into the transfer catheter 20 so that the implant can be removed or redeployed. If proper operation is confirmed, the connector 64 is activated to release the braid or bundle of the implant 1. The pusher catheter 30 and the transfer catheter 20 are slightly withdrawn while maintaining the connection between the implant 1 and the device 10 by a releasable gripping mechanism. Subsequently, the grasping mechanism 50 is operated to release the commissural point of the implant 1. The pusher catheter 30 is retracted into the transfer catheter 20 and the transfer catheter 20 and guide wire 70 are withdrawn from the patient.

  7-21 illustrate another embodiment of the transfer device 100, which is generally similar (particularly indicated by similar numbers) to the transfer device 10 described above. However, the transfer device 100 includes a placement tether assembly 110 whose distal end has a sliding release mechanism for releasing the connection to the implant 1 as best seen in FIGS. .

  More specifically, the placement tether assembly 110 includes a plurality of tethers 104 that are each arranged in a substantially closed loop. These looped tethers 104 pass through portions of the implant 1 and can therefore maintain the implant 1 in a desired position during the procedure (eg, preventing distal movement of the implant 1). it can). These tethers can be detached from the implant 1 by releasing one end of each tether 104 and effectively opening the loop shape. In this regard, pulling out the placement tether assembly 110 will also pull the tether 104 out of the implant 1.

  The release mechanism of the placement tether assembly 110 is triggered by advancing the sliding member 114 from the retracted position seen in FIGS. 7 and 9 to the position seen in FIGS. The tether 104 is connected to the distal end 114B of the pusher member 114 (eg, either fixed in position or returned to the proximal end of the catheter 110 through the member 114), for illustration purposes. Note that 9 and FIG. 10 are not so illustrated. First, the free end 104B of the tether 104 is placed in the recess 114A of the sliding member 114 and captured by the first slot 112A of the outer tether sheath 112. As the sliding member 114 advances, the recess 114A is positioned directly below the wider second slot 112B, thereby releasing the free end 104B of the tether 104.

  As best shown in FIG. 9, the free end 104B of the tether 104 generally has a larger size or diameter than the rest of the tether 104 and has a variety of different shapes, such as round, spherical, or even square. May be. The first slot 112A is sufficiently large to accommodate the diameter of the tether 104, but smaller than the diameter of the free end 104B, so that the tether 104 moves within the slot 112A without passing through the slot 112A. Can slide laterally.

  The second slot 112B is located distal to the first slot 112A and has a width greater than the free end 104B. In this regard, when the recess 114A is aligned under this second slot 112B as shown in FIG. 10, the free end 104B is released so that the tether 104 is in a substantially linear state as in FIG. Can take.

  Although two slots are shown, in another embodiment, a single slot may be used instead. Specifically, the single slot may be similar in size to the slot 112A but extends to the distal end of the tether sheath 112. In this regard, free end 104B is released when recess 114A is advanced out of tether sheath 112.

  The deployment tether assembly 110 may be constructed to have an outer diameter that is small enough to be slidably received within one of the lumens 34 or 36 of the pusher catheter 30 shown in FIG. 2a or 2b. Good.

  FIGS. 11-22 illustrate the proximal end or handle assembly 200 of the transfer device 100. The handle assembly generally includes a valve holding cable operation unit group 210, a pusher catheter operation unit 250, a drive mechanism 260, an irrigation port 280, and a tether operation assembly 300.

  The valve holding cable operation unit group 210 includes a plurality of valve holding cable operation units 212 accommodated in the recesses 214 of the handle 200 and a locking pin 216. The individual valve holding cable operating portions 212 are best shown in FIGS.

  FIG. 12 shows an exploded view of the individual valve holding cable operation section 212. The operating portion 212 includes a housing 218 to which the proximal end of the elastomeric sheath 44 (see FIG. 3) of the holding cable 40 is attached. Housed within the housing 218 is a thumb slide 220 that is connected to the wire 42 of the holding cable 40. Behind the thumb slide 220 is a spring biased catch 222. In the actuated state, pulling the thumb slide back toward the catch 222 pulls the wire 42 against the sheath 44 so that the hook 52 retracts into the mouth 54 at the distal end of the cable 40. The catch 222 maintains the retaining cable 40 in the closed position. By pushing the catch 222, the hook 52 can be quickly released from the mouth portion.

  FIG. 14 shows the thumb slide 220 in the forward open position. The corresponding open position of the distal end of cable 40 is also shown. FIG. 15 shows the thumb slide 220 in the rear closed position. The corresponding closed position of the distal end of cable 40 is also shown. Further, a locking pin 216 is inserted through the housing 218 and thumb slide 220 to prevent accidental release of the implant 1 held in the mouth 54 of the holding cable 40.

  Referring to FIG. 11 again, a state in which three operation units 212 are arranged in the handle 200 is illustrated. In addition, a state in which a single locking pin 216 passes through the handle 200 and all three operation units 212 is also illustrated. The locking pin 216 is a precautionary measure that prevents any of the operation units 212 from being inadvertently opened. After confirming the position and operation of the valve, the doctor can remove the single pin 216 to unlock all three operation portions 212.

  FIG. 15 is a partial view of the handle 200 of the device 100. FIG. 15 shows a pusher catheter operating portion 250, which is illustrated as a sliding ring 250 that slides along the handle 200. The ring 250 is connected to the pusher catheter 30 via a slot 252 on the side of the handle 200. When the ring 250 is advanced to the farthest position, it can rotate to lock the pusher catheter to the valve retention cable 40.

  The drive mechanism 260 is shown in FIG. Drive mechanism 260 includes a lead screw 262 and a threaded nut combination 264. The threaded nut combination 264 includes a nut 266 and a quick release 270 housed within the knob 268. As the knob 268 rotates, the nut 266 acts against the lead screw 262. The knob 268 is fixed to the handle 200 in the axial direction. The lead screw 262 is slidably accommodated in the handle 200. Therefore, when the nut 266 acts on the lead screw 262, the lead screw 262 moves forward or backward within the handle 200. Lead screw 262 is connected at its distal end to transfer catheter 20. Therefore, the relative movement between the pusher catheter 30 and the transfer catheter 20 can be adjusted with high accuracy by the rotatable screw-type nut combination 264. The quick release 270 takes the form of a button or lever, and the nut 266 can be unscrewed from the lead screw 262 to quickly retract the pusher catheter 30 and valve retention cable 40 into the transfer catheter 20.

  It has been found that if the operation of retracting the implant into the transfer catheter 20 is performed quickly, the retract can be further improved. When retracted slowly, the risk of buckling of the catheter increases. Therefore, the handle 200 was designed so that the implant could be quickly retracted into the device 100 when needed. This is accomplished by rotating the ring 250 to the locked position to ensure that the pusher catheter 30 and valve retention cable 40 are secured together and retracted simultaneously when the handle is retracted to the transfer catheter. Is done. Pulling the knob 268 and pushing the quick release 270 while holding the transfer catheter 20 in a stable position will quickly pull the implant into the transfer catheter 20.

  Various components of the tether manipulation assembly 300 are shown in FIGS. The tether operation assembly 300 generally includes a tether release operation unit 310 and a tether arrangement mechanism 340.

  A tether release operating portion 310 is shown in FIGS. 17 and 18 and includes a housing 312 and an operating knob 314. The housing 312 is secured to the proximal end of the outer tether sheath 112 (see FIGS. 9 and 10) of the deployment tether assembly 110. The operating knob 314 can slide axially relative to the housing 312 and is attached to the proximal end of the sliding member 114 (FIGS. 9 and 10). Therefore, when the operation knob 314 is in the front position shown in FIG. 18, these tethers are released. When the operating knob 314 is in the rear position shown in FIG. 17, these tethers are captured in the first slot 112 </ b> A of the outer tether sheath 112. In the illustrated embodiment, the operation knob 314 can be locked in the closed state by rotating the operation knob 314 to the closed position. A clip 320 is also provided, which can be used to prevent the operating knob 314 from moving to the open position if the operating knob 314 is accidentally activated. When it is desired to release the tether, the clip 320 can be easily removed.

  FIGS. 19-21 show the tether placement mechanism 340. The tether placement mechanism is a slide lock that includes a housing 342, a lever 344 and a clamp lock 346. The housing 342 passes through the outer tether sheath 112 and holds the tether sheath between the lever 344 and the clamp lock 346. When the lever 344 is lowered to the closed position shown in FIG. 20, the outer tether sheath 112 and the tether housed therein are clamped between the lever 344 and the block 346 and cannot slide. Therefore, the tether placement mechanism 340 is fixed to the outer tether sheath 112. When lever 344 is in the open position, tether placement mechanism 340 can slide over outer tether sheath 112.

  FIGS. 22-29 show the mode of transferring the implant 1 using the transfer device 100 according to the present invention. First, the implant 1 is loaded into the transfer device 100. After rinsing the selected valve, each of the three valve retention cables 40 is individually attached to each of the wire-like eyelets in the implant. This is done by opening the valve holding cable operating section 212 and pushing the thumb slide 220 forward to expose the hook 52 from the mouth 54. The hook 52 passes through the wire-shaped small hole and retracts the thumb slide 220 backward until it engages with the catch 222. As a result, the slide 220 is locked, and the hook 52 closes the mouth 54. In addition, the outer elastomer sheath 44 of the valve holding cable 40 is also compressed, so that the tightening between the hook 52 and the mouth portion 54 is maintained even when a sufficient traction force is applied to the cable to extend the cable. Preventing accidental liberation inside.

  After all three valve retention cables 40 are attached, the placement tether 104 is attached to the implant 1. (Alternatively, a position tether 104 may be attached in front of the valve retaining cable 40.) This is because each of the three tethers 104 is spaced 120 degrees apart through the center of the implant and the ventricular snare of the implant support structure. This is done by passing from the inside to the outside. After all three tethers 104 have been passed, these tethers 104 are returned through the valves and the three tethers 104 are locked into the slots 112A of the outer tether sheath 112. The locking is performed by pulling the operation knob 314 and rotating the operation knob 314 to the locking position shown in FIG.

  Next, the pusher catheter 30 is pushed forward to capture the valve holding cable 40. At the farthest position of the pusher catheter operation portion ring 250, the ring 250 is rotated to fix the position of the pusher catheter 30 with respect to the valve holding cable 40.

  Thus, the implant 1 is ready for loading into the transfer catheter 20. Rotating the drive knob 268 toward the practitioner advances the transfer catheter 20 and slowly retracts the implant 1 into the distal end of the transfer catheter 20. By paying attention to the position of the implant during the loading of the implant 1, it is possible to observe whether the implant is oriented in such a way that it can be turned over so that the implant can be turned over. At this point, the tether placement mechanism 340 is in the release position, but the tether placement mechanism 340 slides down on the sheath 112 until it contacts the transfer catheter manifold 282 (FIG. 11) and the lever 344 moves to the locked position. Move.

  As the implant continues to be loaded into the transfer catheter 20, the tether 104 and tether sheath 112 retract and the tether placement mechanism 340 moves proximally relative to the transfer catheter manifold 282. If the dilator tip 80 is partially retracted into the transfer catheter 20, the implant is fully loaded and movement between the dilator tip and the transfer catheter tip is smooth.

  As shown in FIG. 22, a guide wire 70 is placed in the patient's native aortic valve and stretched through the vascular introducer at the femoral artery access site. The proximal end of the guide wire is inserted into the dilator tip 80 of the loaded transfer system and the entire transfer system is advanced along the guide wire until the guide wire is visible through the proximal end of the transfer system. Thus, the proximal end of the guide wire is kept stationary to maintain the wire position within the patient's left ventricle and the transfer system is advanced through the introducer into the vasculature and across the patient's native aortic valve 4. (It is best seen in FIG. 23). The guide wire passes through the lumen 32 of the pusher catheter 30.

  Referring to FIG. 24, the transfer sheath 20 is retracted proximally to expose a portion of the implant 1 and the tether 104. This is done by rotating the drive knob 268. When the implant 1 is exposed, the implant 1 expands itself against the patient's native valve 4. During deployment, the practitioner maintains the implant position within the patient's native valve. However, if the implant is pulled too high or too low against the patient's native valve, the implant can be captured again by reversing the direction of rotation of the drive knob 268 and pulling the implant back into the sheath 20. Can be rearranged.

  As shown in FIG. 25, the implant 1 is then folded, or flipped, by restraining the implant 1 with the tether 104 and pushing the proximal portion of the implant distally with the placement tether assembly 110. More particularly, when the first layer of implant is deployed, the tether placement mechanism 340 reaches the delivery catheter manifold. As a result, the position of the ventricular snare (distal end) of the implant is fixed so that further advancement of the implant shortens and flares the implant in preparation for valve reversal.

  Having described the aspect of the valve deploying and flaring, this is an anchoring action in which the implant expands into contact with the patient's native valve tissue and the aortic flare of the element becomes a substantial resistance to movement. is there. After initiation of the anchoring operation, transfer catheter 20 is advanced through the access site and the patient vasculature. In this way, the distal tip of the delivery catheter coaxial with the patient's native valve matches the curve of the delivery catheter 20 that fills the outer curvature of the patient's native aortic arch.

  If the valve is continuously deployed using the drive knob after the catheter 20 has been advanced, the implant is inverted. When the implant is inverted, the tissue valve component of the implant also deploys. When the implant is flipped, the valve begins to function, but this function is somewhat limited due to the close proximity of the tether and the valve operating cable.

  After performing the inversion, the practitioner releases the tether. First, the tether arrangement mechanism 340 is released by releasing the lever 344 and releasing it from the clamp lock 346. The tether placement mechanism 340 is free to move along the outer tether sheath 112. The drive knob 268 is rotated to further return the transfer catheter 20 away from the implant. When the transfer catheter 20 is sufficiently retracted, the tether 104 can be removed by rotating the operation knob 314 of the tether release operation unit 310 to loosen the tension. When the tether release operating portion 310 is slowly pulled, the tether 104 is separated from the implant.

  When the tether 104 is removed, only the valve holding cable 40 remains connected to the implant 1 as shown in FIG. As noted above, these cables 40 are attached to proximal features on the implant (e.g., commissure points), and if a problem occurs during the transfer operation, the physician can place the implant 1 completely within the transfer device 100. Can be returned. Specifically, to observe full valve function without releasing the implant, the physician rotates the ring 250 away from the practitioner, slides the ring 250 proximally, and retracts the pusher catheter 30. Start by. As the pusher catheter 30 is retracted, the prosthetic valve begins to function fully. Other attachments of the transfer system to the implant via the valve retention cable 40 have little impact on the function of the implant.

  When the physician is satisfied with the results, the implant is released by pulling the locking pin 216 at the proximal end of the handle assembly 200. When the locking pin 216 is removed, the three valve holding cable operation portions 212 can be sequentially released. This is done by pressing the catch 222 to slide the thumb slide 220 forward and release the implant 1. Each cable can be individually retracted into the transfer catheter after disengagement. When all three cables are released, the valve is fully implanted and the transfer system can be removed from the patient's vascular introducer.

  Finally, the transfer device 100 and guidewire 70 are removed from the patient, leaving only the functioning valve implant 1 as shown in FIG.

Although the present invention has been described with respect to particular embodiments and applications, those skilled in the art will further understand in light of the present teachings without departing from or exceeding the spirit of the scope of the claimed invention. Embodiments and modifications can be made. Therefore, it should be understood that the drawings and specification provided herein are provided by way of example to facilitate understanding of the invention and should not be construed as limiting the scope thereof.

Claims (15)

A reversible element transfer system comprising:
A transfer catheter;
A pusher catheter slidably disposed within the transfer catheter;
A tubular reversible element;
A deployment mechanism for releasably connecting the reversible element to the transport system, only including,
While the reversible element is advanced from the delivery catheter, the placement mechanism initiates reversal of a predetermined length of the reversible element by not further advancing the distal portion of the reversible element. , Reversible element transfer system.   The transfer system of claim 1, wherein the placement mechanism further includes a plurality of tethers.   The transfer system of claim 2, wherein the plurality of tethers are connected to the pusher catheter.   The transfer system of claim 2, wherein the plurality of tethers are connected to a transfer sheath of the transfer catheter.   The transfer system according to claim 2, wherein the plurality of tethers are connected to an intermediate region of the invertible element.   The transfer system of claim 2, wherein the plurality of tethers are connected to a distal region of the invertible element.   The transfer system of claim 2, wherein each of the plurality of tethers has a first end that is selectively releasable from the placement mechanism.   8. The transfer system of claim 7, further comprising a tether release mechanism for selectively engaging and releasing a first end of each of the plurality of tethers. A reversible element transfer system comprising:
A transfer catheter;
A pusher catheter slidably disposed within the transfer catheter;
Tubular reversible element and
A deployment mechanism for releasably connecting the reversible element to the transfer system, only including,
The arrangement mechanism is for a reversible element that limits distal movement of the reversible element during a reversal operation of the reversible element , thereby reversing a predetermined length of the reversible element. Transport system.   The delivery device of claim 9, wherein the placement mechanism includes a plurality of tethers, each of the plurality of tethers being connected to the delivery catheter proximate a distal end of the invertible element.   The delivery device of claim 9, wherein the placement mechanism includes a plurality of tethers, each of the plurality of tethers being connected to the invertible element and the delivery catheter.   The transfer device of claim 9, further comprising a plurality of attachment cables releasably connected to a proximal end of the reversible element. The placement mechanism
An outer sheath having a first slot;
The transfer device according to claim 9, further comprising a sliding member disposed in the outer sheath and having a recess.   14. The transfer device of claim 13, wherein the placement mechanism includes a plurality of tethers, each of the plurality of tethers having an end sized to fit within a recess in the sliding member. An apparatus for transferring a support structure to a target site,
A transfer catheter containing a tubular support structure;
It said support structure, and advancing mechanism can proceed axially through the delivery catheter,
Do not advance the distal portion of the support structure beyond a predetermined distance distal to the distal end of the transfer catheter , and set a predetermined length proximal to the support structure in the distal portion of the support structure. A stop mechanism that can be reversed with
Transfer device to a target site of a support structure including a release mechanism.