Modular pre-loaded medical implant and delivery system

Abstract

A modular preloaded implant subassembly that can be packaged separately from a handle, allowing any one of a plurality of separately packaged modular preloaded implants to be used with a common handle.

Description

Related Applications

[0001]

[0001] (Cross - Reference to Related Applications) This application claims priority to U.S. Provisional Patent Application No. 63 / 125,260, filed on December 14, 2020, the entire disclosure of which is incorporated herein by reference for all purposes.

[0002]

[0002] (Incorporation by Reference) All publications and patent applications mentioned in this specification are incorporated herein by reference as if each individual publication or patent application was specifically and individually indicated to be incorporated by reference.

Technical Field

[0003] This disclosure relates to modular pre - loaded medical implants and delivery systems.

Background Art

[0004]

[0003] Many implantable medical devices are adapted to be delivered to a target location within a patient using a delivery system. The delivery system generally includes an external handle sub - assembly that facilitates one or more aspects of implant delivery and implantation. Some medical devices are connected to the delivery system during manufacture and packaged with the delivery system. During a medical procedure, the implant will be disconnected and detached from the delivery system to fully implant the medical device.

[0005]

[0004] For various reasons, some medical procedures may require that two or more implants be prepared and ready to be implanted at any time as needed. For example, if an implant is damaged when it comes out of its packaging or is unsafe, another implant may need to be taken out of its packaging and used instead. Also, some medical procedures may require that multiple implants be ready at any time, each having at least one physical characteristic different from at least one of the other available implants. For example, some procedures may involve delivering implants to anatomical locations where there is some variability in size and / or configuration among patients. Details of a patient's anatomical structure may not be known or confirmed until the procedure begins, and these will be determined using one or more imaging techniques (e.g., X-ray, fluoroscopy, etc.). Depending on the anatomical structure of a particular patient, implants of different sizes and / or configurations must be available as needed. The configuration of the implants and / or the way the implants are used may also influence how many implants must be ready to be implanted at any time for any particular procedure. For example, the number and configuration of individual implant components may necessitate having several implants with different components of varying sizes. In addition, the various feasible sizes and / or configurations for one or more individual components may require a matrix of implant candidates with components of different sizes and / or configurations, all of which must be shipped for a specific procedure and available for use at any time during the procedure. Depending on the procedure, several implants may be required and made available for selection—more than five, more than ten, or in some cases more than fifteen or even more.

[0006]

[0005] When the delivery system is attached to the implant during manufacturing and packaged in this manner, each package (e.g., box) will have a complete system including the implant plus a potentially bulky handle. For medical procedures that require several or many implants to be available for use, multiple packages, each containing a delivery system attached to an implant, may be needed close at hand for medical personnel.

[0007]

[0006] In addition, some medical procedures are performed in the cardiac catheterization laboratory ("catheter lab"), where there is often little space available for medical supplies such as packaging and boxes containing implants and delivery systems. In some cases, the number of delivery system and implant packages is so large that they have to be placed outside the catheter lab, forcing medical staff to leave the catheter lab during a procedure to retrieve the desired implant. [Prior art documents] [Patent Documents]

[0008] [Patent Document 1] U.S. Provisional Patent Application No. 63 / 125,260 [Overview of the project] [Problems that the invention aims to solve]

[0009]

[0007] Some medical procedures would benefit from having packaging and assembly solutions that reduce the amount of packaging required for the procedure. [Means for solving the problem]

[0010]

[0008] One aspect of the disclosure is an implant subassembly adapted to be connected to a handle subassembly during a medical procedure for implanting an implant in a patient. The implant subassembly may comprise a cartridge and an implant, the implant having a proximal end, an elongated flexible tubular member having a distal end adjacent to the proximal end of the implant, and an implant connecting mechanism comprising first and second connecting members extending through the flexible tubular member, the first and second connecting members being positioned and configured to be connected to the proximal end of the implant in a first state and to release the proximal end of the implant in a second state.

[0011]

[0009] In this embodiment, the flexible tubular member may have a helical coil element along at least a portion of its length. The helical coil element may be located at the distal end of the flexible tubular member, and the flexible tubular member may optionally further have a flexible tube connected to the helical coil element and located proximal to the coil element.

[0012]

[0010] In this embodiment, the flexible tubular member may include a flexible tube.

[0013]

[0011] In this embodiment, the implant subassembly may have a proximal end configured to lock into the handle subassembly.

[0014]

[0012] In this embodiment, the implant subassembly may have a proximal end that is sized and configured as follows: the proximal end of the implant subassembly may be sized and configured to fit through an elongated tubular member of the handle subassembly into the handle of the handle subassembly. The proximal end of the implant subassembly may be configured to lock in place relative to the handle. The proximal end of the implant subassembly may include a detachable component and a static component that are integrally connected in a first state when the proximal end is locked in place relative to the handle, the detachable component being fixed to a first connecting member and the static component being fixed to a second connecting member, and the detachable component being configured to separate from the static component in a second state when the implant is released from the connecting mechanism. In this embodiment, the static component is locked in place relative to the handle, and the detachable component may be adapted to be detached from the static component by optionally moving the detachable component proximal to the static component, the proximal movement of the detachable component optionally moves the first connecting member proximal to release the implant from the connecting mechanism.

[0015]

[0013] In this embodiment, the proximal end of the implant subassembly may be configured to lock the first connecting member in a predetermined position relative to the handle. The first connecting member is optionally axially movable relative to the second connecting member when an axial force is applied to the contact surface between the detachable component and the static component of the implant subassembly.

[0016]

[0014] In this embodiment, the proximal end of the implant subassembly optionally includes a region having an outer dimension smaller than that of an axially adjacent region, the smaller outer dimension being adapted to lock the proximal end in place with respect to the handle. The region is optionally a first region, and the proximal end of the implant subassembly optionally includes a second region that is axially spaced from the first region and has an outer dimension smaller than that of an axially adjacent region, the smaller outer dimension of the second region being adapted to lock the proximal end in place with respect to the handle. A detachable component optionally includes a first region, and a static component optionally includes a second region, the detachable component is fixed to a first connecting member, and the detachable component and the first connecting member are adapted to move proximal to the static component to release the implant from the connecting mechanism.

[0017]

[0015] In this embodiment, the proximal end of the implant subassembly has first and second recesses configured to be optionally locked in place with respect to the handle of the handle subassembly.

[0018]

[0016] In this embodiment, the implant subassembly may further comprise an implant subassembly packaging in which a handle used for delivering the implant is not optionally positioned.

[0019]

[0017] In this embodiment, the distal end of the implant subassembly has at least one surface that is optionally configured and sized to connect to the proximal end of the delivery catheter. The distal end of the implant subassembly is optionally the distal end of the cartridge.

[0020]

[0018] One aspect of the present disclosure is an implant and delivery system adapted to be coupled during a medical procedure for delivering an implant. The system includes an implant subassembly, the implant subassembly being a cartridge and an implant, the implant having a proximal end; an elongated flexible tubular member having a distal end adjacent to the proximal end of the implant; and an implant coupling mechanism including first and second coupling members extending through the implant flexible tubular member, the first and second coupling members being positioned and configured to be coupled to the proximal end of the implant in a first state and to release the proximal end of the implant in a second state. The system further includes a handle subassembly, which comprises a handle comprising an outer housing and a handle actuator, and a handle elongated tubular member operably communicating with the handle actuator, wherein the operation of the handle actuator causes axial movement of the handle elongated tubular member, the handle elongated tubular member having a lumen sized to receive therein the proximal end of an implant subassembly, an implant flexible tubular member, and first and second connecting members, and the handle may further include an implant subassembly locking mechanism positioned and adapted to be operated by the user to lock the proximal end of the implant subassembly within the handle after the implant subassembly has been moved proximal through the handle elongated tubular member into the handle during a medical procedure for implanting the implant.

[0021]

[0019] In this embodiment, the handle subassembly optionally includes an implant subassembly stopper that is at least partially located within the handle, the implant subassembly stopper being positioned within the handle to prevent the proximal end of the implant subassembly from moving further proximal within the handle. The implant subassembly stopper is optionally positioned to prevent the proximal end of the implant subassembly from moving further proximal within the handle, in a position that axially aligns one or more locking members of the implant subassembly locking mechanism with one or more corresponding locking features on the proximal end of the implant subassembly.

[0022]

[0020] In this embodiment, the implant subassembly locking mechanism optionally includes an actuator and one or more locking elements, the actuator being configured to be actuated by the user to bring one or more locking elements into contact with the proximal end of the implant subassembly and lock the proximal end of the implant subassembly in a predetermined position. The actuation of the actuator optionally moves one of the one or more locking elements radially inward to bring it into contact with the outer surface of the proximal end of the implant subassembly and lock the proximal end of the implant subassembly in a predetermined position. The outer surface optionally is the outer surface of a detachable component of the implant subassembly, which optionally is fixed to a first connecting member. The actuation of the actuator optionally moves a second locking element radially inward to bring it into contact with a second outer surface of the proximal end of the implant subassembly and further lock the proximal end of the implant subassembly in a predetermined position. The second outer surface is optionally the outer surface of the static component of the implant subassembly.

[0023]

[0021] In this aspect, the handle subassembly optionally includes a second handle actuator, and the second handle actuator is operably in communication with an implant subassembly locking mechanism such that when the second handle actuator is actuated, a first portion of the implant subassembly locking mechanism is moved. The first portion may include a proximal locking member. When the second handle actuator is actuated, the second locking member may not be moved together with the first locking member.

[0024]

[0022] In this aspect, the handle subassembly further includes a second handle actuator, and the second handle actuator is operably in communication with a first coupling member such that when the second handle actuator is actuated, the first coupling member is axially moved to release the implant from the coupling mechanism.

[0025]

[0023] In this aspect, the implant subassembly is optionally packaged in a first package, and the handle subassembly is packaged in a second package different from the first package.

[0026]

[0024] In this aspect, the implant elongated flexible tubular member optionally has a distal end, the handle elongated tubular member has a distal end, and the distal end of the implant elongated flexible tubular member is optionally more flexible than the distal end of the handle elongated tubular member.

[0027]

[0025] In this aspect, the implant elongated tubular member optionally includes a coil element.

[0028]

[0026] One aspect of the present disclosure is a method for assembling an implant subassembly and a handle subassembly. The method optionally includes the steps of: removing an implant subassembly from a first package, the implant subassembly comprising a proximal end and a folded implant in a cartridge; removing a handle subassembly from a second package, the handle subassembly comprising a handle and an elongated handle tubular member operably communicating with a handle actuator, the operation of which causes axial movement of the elongated handle tubular member; advancing the proximal end of the implant subassembly into the distal end of the elongated handle tubular member, through the elongated handle tubular member into the handle of the handle subassembly; and locking the proximal end of the implant subassembly in a predetermined position relative to the handle subassembly.

[0029]

[0027] In this embodiment, the step of advancing the proximal end of the implant subassembly into the handle optionally includes advancing the proximal end of the implant subassembly until it engages with the implant subassembly stopper in the handle.

[0030]

[0028] In this embodiment, the step of locking the proximal end of the implant subassembly to the handle subassembly optionally includes the step of moving the locking element to a locked position relative to the proximal end of the implant subassembly.

[0031]

[0029] In this embodiment, the step of moving the locking element to a locked position relative to the proximal end of the implant subassembly optionally includes the step of moving the locking element until it engages with a detachable component of the implant subassembly, the detachable component being fixed to a first connecting member of the implant subassembly, the first connecting member portion of the connecting mechanism being connected to the implant in a first state, and the first connecting member being movable relative to the implant to release the implant.

[0032]

[0030] In this embodiment, the step of locking the proximal end of the implant subassembly to the handle subassembly may include the step of moving the second locking element until it engages with the proximal end of the implant subassembly. The step of moving the second locking element optionally includes the step of moving the second locking element until it engages with a static component of the implant subassembly, the static component optionally being connected to a second connecting member of a connecting mechanism, and the second locking element and the second connecting member are not axially movable after being locked in place relative to the handle.

[0033]

[0031] In this embodiment, the step of locking the proximal end of the implant subassembly optionally includes the step of activating the handle lock actuator, and optionally the step of activating the handle lock actuator by pushing it down.

[0034]

[0032] In this embodiment, the method may include the steps of delivering the implant to a target location and releasing the implant, the releasing step optionally including the step of operating a handle actuator to move a detachable component at the proximal end of the implant subassembly fixed to the implant coupling member.

[0035]

[0033] In this embodiment, the process optionally further includes advancing an elongated implant tubular member having a distal end adjacent to the proximal end of the implant through an elongated handle tubular member.

[0036]

[0034] One aspect of the disclosure is a method for assembling an implant subassembly and a handle subassembly. The method may include the steps of advancing the proximal end of the implant subassembly into the distal end of the elongated handle tubular member of the handle subassembly, through the elongated handle tubular member, into the handle of the handle subassembly, and locking the proximal end of the implant subassembly in a predetermined position relative to the handle subassembly. The implant subassembly further includes an implant and a cartridge, wherein the implant is compressed within the cartridge during the advancing step. The handle subassembly may further include a handle actuator operably communicated with the elongated handle tubular member such that the operation of the handle actuator causes axial movement of the elongated handle tubular member.

[0037]

[0035] In this embodiment, the step of advancing the proximal end of the implant subassembly into the handle may include advancing the proximal end of the implant subassembly until it engages with the implant subassembly stopper in the handle.

[0038]

[0036] In this embodiment, the step of locking the proximal end of the implant subassembly to the handle subassembly may include the step of moving the locking element to a locked position relative to the proximal end of the implant subassembly. The step of moving the locking element to a locked position relative to the proximal end of the implant subassembly may include the step of moving the locking element until it engages with a detachable component of the implant subassembly, the detachable component being fixed to a first connecting member of the implant subassembly, the first connecting member portion of the connecting mechanism being connected to the implant in a first state, and the first connecting member being movable relative to the implant to release the implant.

[0039]

[0037] In this embodiment, the step of locking the proximal end of the implant subassembly to the handle subassembly may include the step of moving the second locking element until it engages with the proximal end of the implant subassembly. The step of moving the second locking element may include the step of moving the second locking element until it engages with a static component of the implant subassembly, the static component being optionally connected to a second connecting member of a coupling mechanism, and the second locking element and the second connecting member being immobile in the axial direction after being locked in place relative to the handle.

[0040]

[0038] In this embodiment, the step of locking the proximal end of the implant subassembly may include the step of activating (optionally pushing down) the handle lock actuator.

[0041]

[0039] In this embodiment, the method further comprises the steps of delivering the implant to a target location and releasing the implant, the releasing step optionally comprising acting a handle actuator to move a detachable component at the proximal end of the implant subassembly fixed to the implant coupling member.

[0042]

[0040] In this embodiment, the process may further include advancing the elongated implant tubular member through the elongated handle tubular member, and the elongated implant tubular member optionally has a distal end adjacent to the proximal end of the implant. [Brief explanation of the drawing]

[0043] [Figure 1] This depicts an example system including a handle subassembly and an implant subassembly. [Figure 2] The image shows an example of a handle subassembly within its packaging. [Figure 3] This image depicts an example of an implant subassembly within its packaging. [Figure 4A] An implant is depicted as an example. [Figure 4B] Figure 4 illustrates the proximal region of an implant as an example. [Figure 5] This diagram illustrates a connection mechanism, showing an example of an implant connected to its proximal end. [Figure 6] The images depict the proximal region of an implant subassembly as an example and a portion of a handle subassembly as an example. [Figure 7] The images depict the proximal region of an implant subassembly as an example and a portion of a handle subassembly as an example. [Figure 8] The image shows the proximal region of an example implant subassembly positioned within a portion of an example handle subassembly. [Figure 9] The diagram depicts an exemplary system including an exemplary handle subassembly and an exemplary implant subassembly. [Figure 10] The diagram depicts an exemplary system including an exemplary handle subassembly and an exemplary implant subassembly. [Figure 11] A delivery catheter is depicted as an example. [Figure 12] This depicts an example of a system connected to the proximal end of a delivery catheter. [Modes for carrying out the invention]

[0044]

[0054] This disclosure relates to a solution for medical implant packaging and delivery systems that can avoid the need to package many complete systems, including an external handle connected to a medical implant. This disclosure relates to a modular pre-loaded implant subassembly that can be packaged separately from the handle subassembly, providing the ability to use any one of many separately packaged modular pre-loaded implants with a common handle. This eliminates the need to pre-connect the implant to the delivery system and package it together with the delivery system, and thus potentially eliminates a considerable amount of packaging and a considerable amount of space required to store the packaged implants during medical procedures.

[0045]

[0055] One aspect of the disclosure describes an implant and delivery system including an implant subassembly adapted to be coupled to a handle subassembly during a medical procedure. The implant subassembly may be packaged separately from the handle subassembly.

[0046]

[0056] Figure 1 shows an example of an implant and delivery system 100 in a disconnected state. The system 100 includes an implant subassembly 300 adapted to connect to a handle subassembly 200 during a medical procedure. Figure 1 shows the two subassemblies before connection, after being removed from separate packaging.

[0047]

[0057] The implant subassembly 300 includes a cartridge 310 and an implant (not visible in Figure 1) positioned within the cartridge 310, the implant being optionally folded and positioned within the cartridge. The implant positioned within the cartridge includes a proximal end of the implant, also not visible in Figure 1. The implant subassembly 300 also includes an elongated flexible tubular member 320 having a distal end (not visible in Figure 1) connected to the proximal end of the implant. The implant subassembly includes a proximal end 330. The elongated flexible tubular member 320 may be configured as a tubular member or as a helical coil member.

[0048]

[0058] In this embodiment, the handle subassembly 200 includes a handle 210 and an elongated tubular member 250 extending within the handle 210 and further distally from the handle 210. The handle 210 also includes an outer housing or shell 212 and a handle actuator 214. The actuator 214 is adapted to be actuated by a user and is operably in communication with the elongated tubular member 250, and the operation of the handle actuator 214 causes axial motion of the elongated tubular member 250, which will be described in more detail later. The tubular member 250 has a distal end 252 and a lumen extending through the tubular member 250 and communicating with the distal end 252. The distal end 252 and the lumen within the tubular member 250 are sized and configured to receive the proximal end 330 of the implant subassembly 300, the implant flexible tubular member 320, and the implant first and implant second connecting members, which will be described later.

[0049]

[0059] Figure 2 depicts packaging 400 as an example for a handle subassembly 200, which has a recess for the handle 210 and a recess for receiving the elongated tubular member 250. One or more sections of the elongated tubular member 250 are adapted to be housed in a non-linear configuration as shown and are configured to return to a linear configuration when removed from packaging 400. One or more sections of the elongated tubular member 250 may also be housed in a linear configuration as shown. The elongated tubular member 250 may be housed in other configurations not shown, any of which may have some degree of nonlinearity in one or more sections along the length of the elongated tubular member 250 within the packaging. Packaging the elongated tubular member 250 in a configuration that is not perfectly straight also reduces the length dimension of the packaging required for the handle subassembly.

[0050]

[0060] In some embodiments that are merely illustrative, the elongated tubular handle member 250 may be made of a flexible tubular material that allows for some degree of bending for packaging. In addition to flexibility (for packaging), the material of the elongated tubular member 250 may also allow for the rigidity necessary for buckling avoidance and implant operation.

[0051]

[0061] Figure 3 illustrates packaging 500 as an example for an individual implant subassembly. The tubular member 320 can optionally be configured in a non-linear configuration as shown to reduce packaging size. The flexibility of the illustrated tubular member 320 would allow individual modular pre-loaded implants to be placed in much smaller packaging than if they were assembled to a handle and packaged as a single unit.

[0052]

[0062] Figures 4A and 4B illustrate implant 600 for illustrative purposes only, showing implant 600 already detached from the handle subassembly and further illustrated in an extended implantation configuration. Implant 600 is one embodiment of an implant that may be packaged as a modular pre-loaded implant according to the disclosure herein. As will be understood, a wide variety of other implants will benefit from incorporating the modular pre-loaded implant concept herein, and implant 600 is merely an illustrative implant. Figure 4B illustrates the proximal region 610 in more detail, including the proximal anchor eyelet 614 and the loop-shaped element 612, which may also be referred to herein as the arrowhead.

[0053]

[0063] Figure 5 illustrates an exemplary coupling mechanism 332, shown connected to the proximal end 610 of the implant 600. In this embodiment, the coupling mechanism holds the implant 600 until it is fully released and ready for implantation in the patient. The coupling mechanism in this embodiment includes a first coupling member 340 and a second coupling member 350. As will be described in more detail later, the first coupling member 340 and the second coupling member 350 are adapted to connect to the proximal end 610 of the implant in a first state and to release the proximal end 610 of the implant in a second state. Generally, in the first coupling state, the second coupling member 350 has a loop-shaped distal end configuration extending into the opening created by the arrowhead 612. The first connecting member 340 (sometimes referred to herein as the lock wire) extends through the second connecting member 350 and the arrowhead 612, and in this configuration, the arrangement between the first and second connecting members and the proximal end of the implant prevents the implant from being released. To release the implant 600, the first connecting member 340 is pulled proximal beyond the arrowhead 612, thereby releasing the proximal end of the implant, which will be described in more detail later.

[0054]

[0064] The first connecting member 340 and the second connecting member 350 extend through the flexible tubular member 320, as shown in Figure 5, and are connected to the respective implant subassembly components at the proximal end of the implant subassembly, as shown in detail in Figures 6-8.

[0055]

[0065] After one of the medical implants is selected from the available implants, the selected modular pre-loaded implant subassembly is removed from its individual packaging, such as packaging 500 shown in Figure 3. A handle subassembly, which may be adapted for use with any of the implant subassemblies, is also removed from its separate packaging. The proximal end 330 of the implant subassembly 300 is then front-loaded into the distal end 252 of the handle subassembly. The flexible tubular member 320, in which the first and second connecting members are located, is advanced proximal through the elongated member 250 into the handle 210.

[0056]

[0066] One aspect of this disclosure is a separate, modular, pre-loaded implant subassembly including a proximal end that can be advanced into a delivery handle and locked in place by a medical professional during a medical procedure, which provides the packaging advantages described herein. Figure 5 depicts an elongated flexible tubular member 320 and a first and second connecting member 340 and a second connecting member 350, both extending through a lumen within the tubular member 320. Figures 6–8 depict merely illustrative embodiments of the proximal end 330 of an implant subassembly, which is sized and configured to be advanced into a handle subassembly and locked in place during a medical procedure. In this particular exemplary embodiment, the first connecting member 340 (one embodiment of which is shown in Figure 5) connects to a detachable component 370 of the proximal end 330 of the implant subassembly 300. The second connecting member 350 (one embodiment of which is shown in Figure 5) connects to a static component 360 of the proximal end 330 of the implant subassembly 300. Preferably, the second connecting member 350 is fixed to the static component 360 while under tension. The second connecting member 350 can be fixed or connected to the static component 360 in a variety of ways, such as by bonding, adhesive(s), or one or more of other common connecting techniques. In this exemplary embodiment, the second connecting member 350 serves to fix the first connecting member 340 in such a way that it locks the implant to the delivery system until the first connecting member 340 is pulled proximal to release the implant. Figure 8 shows a perspective cross-sectional view showing that the first connecting member 340 extends through and is connected to the static component 360 and the detachable component 370. The first connecting member 340 is fixed to the detachable component 370 such that when the detachable component 370 is moved in the proximal direction, the first connecting member 340 is also moved in the proximal direction (and relative to the static component 360 which does not move axially) to release the implant from the delivery system.

[0057]

[0067] One aspect of the present disclosure is a handle subassembly including an implant subassembly locking mechanism positioned and adapted to lock the proximal end of the implant subassembly within the handle after the implant subassembly has been moved proximal through a handle tubular member into the handle during a medical procedure to deploy an implant. The implant subassembly locking mechanism may be adapted to be actuated by a user to lock the proximal end of the implant subassembly within the handle, one embodiment of which is described in relation to Figures 6-8.

[0058]

[0068] In some exemplary embodiments, the handle subassembly may further include an implant subassembly stopper at least partially located within the handle, the implant subassembly stopper positioned within the handle to contact the proximal end of the implant subassembly and to stop the proximal end of the implant subassembly from moving further proximal, and the stopper is positioned so as to activate an implant subassembly locking mechanism to lock the proximal end of the implant subassembly within the handle. The implant subassembly stopper would offer the advantage of automatically stopping the implant subassembly at a specific location within the handle such that the locking process is simple and can be successfully performed by user operation of a lock actuator, which will be described in more detail later. Figure 8 illustrates an exemplary stopper 295 having a distal end positioned and configured to stop the proximal movement of the implant subassembly at a specific location. Here, either of the stoppers can also function as a safety release member that must be removed from the handle before the implant is released. For example, the stopper and safety release mechanism can interact with the handle such that the connecting member 340 cannot be physically pulled in the proximal direction until the stopper / safety member is removed from the handle.

[0059]

[0069] In the exemplary embodiments shown in Figures 6-8, the implant subassembly locking mechanism of the handle subassembly includes a lock actuator 280 (see also Figure 1) positioned and adapted to the handle housing 212 to be operated by the user to lock the proximal end 330 of the implant subassembly into the handle after the implant subassembly has been moved proximal through the elongated tubular member of the handle into the handle during a medical procedure to implant the implant. The implant subassembly locking mechanism includes first and second locking elements 282 and 284 positioned and configured to act radially inward toward the proximal end 330 of the implant subassembly when the lock actuator 280 is actuated (for example, when a handle button is pressed down). The first and second locking elements 282 and 284 are positioned and configured to move radially inward when the lock actuator 280 is actuated, and to contact the static component 360 and the detachable component 370, respectively, to lock the proximal end 330 in place relative to the handle.

[0060]

[0070] In this particular embodiment, which is merely illustrative, the locking elements 282 and 284 are configured as clips, and each locking element has a surface configured to lock into contact with the outer surfaces of axially spaced regions 362 and 372, respectively, on the static component 360 and the detachable component 370. In this non-limiting embodiment, the axially spaced regions 362 and 372 each have a smaller outer dimension than the axially adjacent region, and the smaller outer dimension conforms the regions 362 and 372 to lock into place relative to the handle. In this embodiment, the regions 362 and 372 can be considered to have recesses on their outer surfaces configured to lock into place relative to the handle of the handle subassembly. In an alternative embodiment, the locking actuator may be unnecessary by having both locking elements 282 and 284 in different spring-loaded configurations so that when the implant subassembly is introduced into the handle subassembly, the fork portion 282 slides over region 372 and then the fork portion 284 drops into region 372. Alternative configurations are conceived. For example, the locking element could be configured as a modulated throttling that closes radially into regions 362 and 372, with the modulation automatically triggered when the proximal end 330 of the implant subassembly passes the handle, thus eliminating the need for a locking actuator. In other embodiments, bosses may be provided to drop into slots in the static component 360 and the detachable component 370. The bosses may or may not be cam-shaped.

[0061]

[0071] As described above, the detachable component 370 to which the first connecting member 340 is fixed is adapted to move proximal to the static component 360 within the handle to retract the first connecting member 340 and release the implant. The detachable component 370 is connected to region 372 such that the detachable component 370 and region 372 move proximal together as a unit. The static component 360 is connected to region 362 such that the static component 360 and region 362 remain stationary together as a unit when the detachable component is pulled proximal. Figure 6 shows the separation point 361 where the detachable component 370 separates from the static component 360. In one embodiment, this is achieved by acting on a handle release actuator 260 (see Figure 1), which is operably in communication with the detachable component 370 via a locking element 284. As shown in Figure 8, the locking element 284 is fixed within a threaded member 290 that is screwed into the handle release actuator 260. When the handle release actuator 260 (not shown in Figure 8) is activated (e.g., rotated), the threaded member 290 is moved axially by its screw relationship, and the handle release actuator 260 is fixed in a predetermined position axially (but can rotate). The axial movement of the threaded member 290 similarly moves the locking element 284 axially. The locking element 284 is locked to a detachable component 370 connected to a first connecting member 340. This exemplary arrangement causes proximal movement of the first connecting member 340, thereby releasing the implant. The activation of the handle release actuator 260 therefore causes the release of the implant. This disclosure therefore describes a modular pre-loaded implant that can be locked in a predetermined position relative to a handle during a medical procedure, and moreover, a modular pre-loaded implant in which the implant connecting member can be moved relative to the handle to facilitate the release of the implant when desired.

[0062]

[0072] The locking element 282 is not located within the screw member 290, and therefore does not move proximal together with the locking element 284 when the handle release actuator 260 is activated. Thus, this configuration is one embodiment of how to prevent static members from moving when a detachable member needs to be moved to release the implant.

[0063]

[0073] The following disclosures illustrate exemplary procedure steps that may be performed during implant linking and delivery. Some of these procedure steps are described above. Not all of the following procedure steps are necessarily required, and one or more steps may actually be for illustrative purposes and / or optional.

[0064]

[0074] One aspect of the present disclosure is a method for assembling an implant subassembly and a handle subassembly. The method may include the step of removing an implant subassembly (e.g., 300) from a first package (e.g., 500), the implant subassembly comprising a proximal end and a folded implant in a cartridge. The method may further include the step of removing a handle subassembly (e.g., 200) from a second package (e.g., 400), the handle subassembly comprising a handle and an elongated handle tubular member operably communicating with a handle actuator (e.g., 214), the operation of which causes axial movement of the elongated handle tubular member. The method may further include the step of advancing the proximal end of the implant subassembly into the distal end of the elongated handle tubular member, through the elongated handle tubular member, into the handle of the handle subassembly. The method may further include the step of locking the proximal end of the implant subassembly in a predetermined position relative to the handle subassembly.

[0065]

[0075] Once the implant subassembly is locked in place relative to the handle, the locked system is in the configuration shown in Figure 9, with the implant tubular member 320 (not visible) located within the handle tubular member 250 and the handle 210. The distal end of the handle tubular member 250 is located immediately proximal to the implant (not visible) in the cartridge. The handle tubular member 250 may be much longer than shown in Figure 9, and the two curves suggest the length of a tubular member 250 that is not shown.

[0066]

[0076] Figure 10 depicts implant 600 in a deployed and optionally curved configuration; however, Figure 10 only shows the relative position of implant 600 within cartridge 310 as an example. Any of the implants in this specification may be non-deployable implants, but they will still be pre-loaded into a cartridge or other elongated housing. Thus, the term cartridge in this specification may be broadly replaced with a more general term such as an elongated housing having a lumen inside, and the cartridge may be rigid.

[0067]

[0077] In some exemplary embodiments, the distal end of the cartridge may then be connected to the proximal end 902 of the delivery catheter 900, one example of which is shown in Figure 11. The distal end 904 of the catheter is also shown. In some exemplary embodiments, the delivery catheter 900 may have a length of 50 to 90 cm, for example, 60 to 80 cm.

[0068]

[0078] Figure 12 illustrates an example of a Luer lock connection between the cartridge and the delivery catheter (after the handle subassembly and implant have been advanced through the delivery catheter).

[0069]

[0079] After the cartridge is connected to the delivery catheter 900, the handle subassembly 200, the handle tubular member 250, the implant tubular member 320, and the implant are advanced distally to the cartridge until the handle contacts the cartridge, as shown in Figure 12. The male thread of the cartridge is configured to engage with the female thread of the delivery catheter control actuator 265, so that once engaged, the operation of the actuator 265 controls the axial movement of the cartridge and the delivery catheter connected to the cartridge at this point. Now that the implant is positioned within the delivery catheter at its distal end, the axial movement of the cartridge and the delivery catheter allows for the implant to be sheathed and re-sheathed as needed. After the implant has been deployed from the delivery catheter, which may occur by moving the delivery catheter relative to the implant, the implant may be released. To allow the implant to be released, a safety member (which may also be a stopper as described herein) as shown at the proximal end of the handle in Figure 9 may be removed. As described in more detail above, the release actuator 260 can be activated to move the locking member 284 proximal, causing proximal movement of the detachable component 370 and the first connecting member 340, thereby releasing the implant. The delivery system may then be removed.

[0070]

[0080] As shown above, the step of advancing the proximal end of the implant subassembly into the handle may further include the step of advancing the proximal end of the implant subassembly until it engages with an implant subassembly stopper (e.g., 295) within the handle.

[0071]

[0081] The step of locking the proximal end of the implant subassembly against the handle subassembly may include moving a locking element (e.g., 284) to a locked position relative to the proximal end of the implant subassembly. The locking element may be moved until it engages with a detachable component (e.g., 370) of the implant subassembly, the detachable component being fixed to a first connecting member (e.g., 340) of the implant subassembly, the first connecting member portion of the connecting mechanism being connected to the implant (e.g., 600) in a first state, and the first connecting member being movable relative to the implant to release the implant. The step of locking the proximal end of the implant subassembly against the handle subassembly may further include moving a second locking element (e.g., 282) until it engages with the proximal end of the implant subassembly and optionally until it engages with a static component (e.g., 360) of the implant subassembly. The static components may be connected to a second connecting member (e.g., 350) of the coupling mechanism, and the second locking element and the second connecting member are not axially movable after being locked in place relative to the handle.

[0072]

[0082] The step of locking the proximal end of the implant subassembly may include the step of activating (optionally pushing down) a handle lock actuator (e.g., 280), although other types of actuators may be used.

[0073]

[0083] At a point in time following the step of locking the proximal end of the implant subassembly, any of the methods herein may further include the steps of delivering the implant to a target location and releasing the implant. The releasing step may include acting a release handle actuator (e.g., 260) to cause movement of a detachable component (e.g., 370) at the proximal end of the implant subassembly, which is fixed to an implant coupling member (e.g., 340).

[0074]

[0084] Next, the entire delivery system may be removed from the patient, leaving the implant embedded in the target location. [Explanation of symbols]

[0075] 100 Implant and Delivery Systems 200 Handle Subassembly 210 Handle 212 Handle Housing 214 Handle Actuator 250 Elongated tubular member 252 Distal end of slender tubular member 260 Handle release actuator 265 Delivery Catheter Control Actuator 280 Lock Actuator 282 The first rock element, the folk section 284 The second rock element: the folk section 290 Screw component 295 Stopper 300 Implant Subassemblies 310 cartridges 320 Elongated flexible tubular member 322 Connection mechanism 330 Proximal end of implant subassembly 332 Connection mechanism 340 First connecting member 350 Second connecting member 360 static components 361 Separation location 362 Locked areas 370 Detachable components 372 Locked areas 400 Handle Sub-Assembly Packaging 500 Implant Subassembly Packaging 600 implants 610 Proximal end of implant 612 Loop-shaped element, arrowhead 614 Proximal anchor eyelet 900 Delivery Catheter 902 Proximal end of delivery catheter 904 Distal end of delivery catheter

Claims

1. An implant and delivery system adapted to be connected during a medical procedure for delivering an implant, An implant subassembly including the following, namely: A cartridge and an implant placed inside the cartridge in a folded state, wherein the implant has a proximal end, An elongated, flexible tubular implant member having a distal end adjacent to the proximal end of the implant, and An implant connection mechanism including a first connecting member and a second connecting member extending through the slender, flexible tubular member of the implant, wherein the first connecting member and the second connecting member are positioned and configured to be connected to the proximal end of the implant in a first state and to release the proximal end of the implant in a second state, and an implant subassembly including an implant connecting member, A handle subassembly including the following, namely: A handle comprising an outer housing and a handle actuator, and A handle slender tubular member operably communicated with the handle actuator, wherein the operation of the handle actuator causes axial movement of the handle slender tubular member, including the handle slender tubular member, The handle slender tubular member has a lumen sized to receive the proximal end of the implant subassembly, the implant slender flexible tubular member, and the first and second connecting members therein. The handle further comprises an implant subassembly locking mechanism positioned and fitted to lock the proximal end of the implant subassembly within the handle after the implant subassembly has been moved proximal through the elongated tubular member of the handle into the handle during a medical procedure to implant the implant, An implant and delivery system equipped with the following features.

2. In the system described in claim 1, The system includes an implant subassembly stopper at least partially located within the handle, the implant subassembly stopper being positioned within the handle to prevent the proximal end of the implant subassembly from moving further proximal within the handle.

3. In the system described in claim 2, The implant subassembly stopper is positioned such that it prevents the proximal end of the implant subassembly from moving further proximal, by axially aligning one or more locking members of the implant subassembly locking mechanism with one or more corresponding locking features at the proximal end of the implant subassembly.

4. In the system described in claim 1, The implant subassembly locking mechanism comprises an actuator and one or more locking elements, wherein the actuator is configured to be operated by a user to bring the one or more locking elements into contact with the proximal end of the implant subassembly and lock the proximal end of the implant subassembly in a predetermined position.

5. In the system described in claim 4, The actuator operates by moving one of the one or more locking elements radially inward, bringing it into contact with the outer surface of the proximal end of the implant subassembly, thereby locking the proximal end of the implant subassembly in a predetermined position.

6. In the system described in claim 5, The system wherein the outer surface is the outer surface of the detachable component of the implant subassembly.

7. In the system described in claim 6, The detachable component is fixed to the first connecting member in a system.

8. In the system described in claim 6, The actuator operates by moving a second locking element radially inward, bringing it into contact with the second outer surface of the proximal end of the implant subassembly, and further locking the proximal end of the implant subassembly in a predetermined position.

9. In the system described in claim 8, The system wherein the second outer surface is the outer surface of the static component of the implant subassembly.

10. In the system described in claim 1, The system includes a handle subassembly which includes a second handle actuator, the second handle actuator being operably in communication with the implant subassembly locking mechanism such that a first portion of the implant subassembly locking mechanism is moved when the second handle actuator is actuated.

11. In the system according to claim 10, The system wherein the first portion of the implant subassembly locking mechanism includes a proximal first locking member.

12. In the system according to claim 11, A system in which, when the second handle actuator is operated, the second locking member is not moved together with the first locking member.

13. In the system described in claim 1 The system includes a handle subassembly which comprises a second handle actuator, the second handle actuator being operably in communication with the first coupling member such that when the second handle actuator is actuated, the first coupling member is moved axially to release the implant from the implant coupling mechanism.

14. In the system described in claim 1, A system in which the implant subassembly is packaged in a first package, and the handle subassembly is packaged in a second package different from the first package.

15. In the system described in claim 1, A system in which the slender, flexible tubular implant member has a distal end, the slender, flexible tubular handle member has a distal end, and the distal end of the slender, flexible tubular implant member is more flexible than the distal end of the slender, flexible tubular handle member.

16. In the system described in claim 1, The aforementioned implant system comprises an elongated, flexible tubular member with a helical coil element.

17. In the system described in claim 16, The system comprises a helical coil element positioned at the distal end of the slender, flexible tubular implant member, and the slender, flexible tubular implant member further comprising a flexible tube connected to the helical coil element and positioned proximal to the helical coil element.

18. In the system described in claim 1, The system comprises an elongated, flexible tubular implant member with a flexible tube.

19. In the system described in claim 1, The implant subassembly comprises a proximal end including a detachable component and a static component, wherein the detachable component and the static component are integrally connected in a first state when the proximal end is fixed in a predetermined position relative to the handle, the detachable component is fixed to the first connecting member, the static component is fixed to the second connecting member, and the detachable component is adapted to be separated from the static component in a second state when the implant is released from the implant connection mechanism.

20. In the system described in claim 19, The system wherein the second connecting member is attached to the static component in a taut state.

21. A method for assembling an implant subassembly and a handle subassembly, wherein the method is: A step of removing an implant subassembly from a first package, wherein the implant subassembly comprises a proximal end and a folded implant within a cartridge. A step of removing a handle subassembly from a second package, wherein the handle subassembly includes a handle and an elongated tubular handle member operably connected to a handle actuator, wherein the operation of the handle actuator causes axial movement of the elongated tubular handle member; The steps include: advancing the proximal end of the implant subassembly into the distal end of the elongated handle tubular member, and advancing it through the elongated handle tubular member into the handle of the handle subassembly; A method comprising the step of locking the proximal end of the implant subassembly in a predetermined position relative to the handle subassembly.

22. In the method according to claim 21, A method comprising the step of advancing the proximal end of the implant subassembly into the handle, wherein the proximal end of the implant subassembly engages with an implant subassembly stopper in the handle.

23. In the method according to claim 21, A method for locking the proximal end of the implant subassembly with respect to the handle subassembly, comprising moving a locking element to a locked position relative to the proximal end of the implant subassembly.

24. In the method according to claim 23, A method comprising the step of moving the locking element to the locking position relative to the proximal end of the implant subassembly, the step of moving the locking element until it engages with a detachable component of the implant subassembly, the detachable component being fixed to a first connecting member of the implant subassembly, a portion of the first connecting member of the connecting mechanism being connected to the implant in a first state, and the first connecting member being movable relative to the implant to release the implant.

25. In the method of claim 24, A method for locking the proximal end of the implant subassembly with respect to the handle subassembly, comprising moving a second locking element until it engages with the proximal end of the implant subassembly.

26. In the method of claim 25, The method comprising the step of moving the second locking element, the step of moving the second locking element until it engages with a static component of the implant subassembly, the static component being connected to a second connecting member of the connecting mechanism, wherein the second locking element and the second connecting member are not axially movable after being locked in a predetermined position relative to the handle.

27. In the method according to claim 23, A method comprising the step of locking the proximal end of the implant subassembly, the step of activating a handle lock actuator.

28. The method according to claim 21, The method further includes the steps of delivering the implant to a target location and releasing the implant, wherein the releasing step includes activating a handle actuator to move the detachable component of the proximal end of the implant subassembly, which is fixed to an implant connecting member.

29. In the method according to claim 21, The method further includes the step of advancing an elongated implant tubular member having a distal end adjacent to the proximal end of the implant through the elongated handle tubular member.

30. A handle subassembly adapted to be connected to an implant subassembly during a medical procedure for implanting an implant in a patient, wherein the handle subassembly is: A handle comprising an outer shell and a handle actuator, The system comprises an elongated tubular member operably connected to the handle actuator, wherein the operation of the handle actuator causes axial movement of the elongated tubular member, The elongated tubular member has a lumen sized to receive the proximal end of the implant subassembly, which includes the implant, A handle subassembly further comprising an implant subassembly locking mechanism positioned and adapted to lock the proximal end of the implant subassembly within the handle after the implant subassembly has been moved proximal within the handle.

31. In the handle subassembly according to claim 30, A handle subassembly further comprising an implant subassembly stopper at least partially disposed within the handle, wherein the implant subassembly stopper is positioned within the handle to contact the proximal end of the implant subassembly and prevent it from moving further proximal, and the implant subassembly stopper is positioned to activate the implant subassembly locking mechanism to lock the proximal end of the implant subassembly within the handle.

32. In the handle subassembly according to claim 31, A handle subassembly, wherein the implant subassembly stopper is also adapted to serve as a safety feature that must be removed from the handle before the implant subassembly is released by the handle.

33. In the handle subassembly according to claim 30, The implant subassembly locking mechanism includes an actuator and one or more locking elements, the actuator being operated by a user to bring the one or more locking elements into contact with the proximal end of the implant subassembly and lock the proximal end of the implant subassembly in a predetermined position, the handle subassembly.

34. In the handle subassembly according to claim 33, The implant subassembly locking mechanism includes a first locking element and a second locking element, and the actuator is configured to be operated by the user to lock the proximal end of the implant subassembly in a predetermined position by bringing the first locking element and the second locking element into contact with first and second axially spaced regions of the proximal end of the implant subassembly.

35. In the handle subassembly according to claim 34, A handle subassembly in which the first locking element and the second locking element are spaced apart such that when the implant subassembly is advanced into the handle, the first locking element engages with a static component of the implant subassembly and the second locking element engages with a detachable component of the implant subassembly.

36. In the handle subassembly according to claim 30, A handle subassembly further comprising a second handle actuator, the second handle actuator being operably communicated with the implant subassembly locking mechanism such that when the second handle actuator is actuated, a first portion of the implant subassembly locking mechanism moves relative to a second portion of the implant subassembly locking mechanism.

37. In the handle subassembly according to claim 36, The first portion of the implant subassembly locking mechanism includes a handle subassembly with a proximal locking element.

38. In the handle subassembly according to claim 36, A handle subassembly in which the second portion of the implant subassembly locking mechanism is not moved together with the first portion of the implant subassembly locking mechanism when the second handle actuator is operated.

39. A handle subassembly according to claim 30, Furthermore, a handle subassembly comprising a handle subassembly package in which the implant is not placed.

40. A method for assembling an implant subassembly and a handle subassembly, wherein the method is: The process involves advancing the proximal end of the implant subassembly into the distal end of the elongated handle tubular member of the handle subassembly, and then advancing it through the elongated handle tubular member into the handle of the handle subassembly, The implant subassembly further includes an implant and a cartridge, wherein during the process, the implant is in a folded state within the cartridge, and the handle subassembly further includes a handle actuator which is operably communicated with the elongated handle tubular member such that the operation of the handle actuator causes axial movement of the elongated handle tubular member, the process being carried out A method comprising the step of locking the proximal end of the implant subassembly in a predetermined position relative to the handle subassembly.

41. In the method according to claim 40, A method comprising the step of advancing the proximal end of the implant subassembly into the handle, wherein the proximal end of the implant subassembly engages with an implant subassembly stopper in the handle.

42. In the method according to claim 40, A method for locking the proximal end of the implant subassembly with respect to the handle subassembly, comprising moving a locking element to a locked position relative to the proximal end of the implant subassembly.

43. In the method of claim 42, A method comprising the step of moving the locking element to the locking position relative to the proximal end of the implant subassembly, the step of moving the locking element until it engages with a detachable component of the implant subassembly, the detachable component being fixed to a first connecting member of the implant subassembly, a portion of the first connecting member of the connecting mechanism being connected to the implant in a first state, and the first connecting member being movable relative to the implant to release the implant.

44. In the method of claim 43, A method for locking the proximal end of the implant subassembly with respect to the handle subassembly, comprising moving a second locking element until it engages with the proximal end of the implant subassembly.

45. In the method of claim 44, The method comprising the step of moving the second locking element until the second locking element engages with a static component of the implant subassembly, the static component being connected to a second connecting member of the connecting mechanism, and the second locking element and the second connecting member being immobile in the axial direction after being locked in a predetermined position relative to the handle.

46. In the method of claim 42, A method comprising the step of locking the proximal end of the implant subassembly, the step of activating a handle lock actuator.

47. The method according to claim 40, The method further includes the steps of delivering the implant to a target location and releasing the implant, wherein the releasing step includes activating the handle actuator to move the detachable component of the proximal end of the implant subassembly, which is fixed to the implant connecting member.

48. In the method according to claim 40, The method further includes the step of advancing an elongated implant tubular member having a distal end adjacent to the proximal end of the implant through the elongated handle tubular member.

49. An implant subassembly adapted to be connected to a handle subassembly during a medical procedure for implanting an implant in a patient, wherein the implant subassembly is: A cartridge and an implant placed inside the cartridge in a folded state, wherein the implant has a proximal end, A slender, flexible tubular member having a distal end adjacent to the proximal end of the implant, An implant subassembly comprising: an implant connecting mechanism including a first connecting member and a second connecting member extending through the slender, flexible tubular member, wherein the first connecting member and the second connecting member are positioned and configured to be connected to the proximal end of the implant in a first state and to release the proximal end of the implant in a second state.

50. In the implant subassembly according to claim 49, The aforementioned elongated, flexible tubular member comprises a helical coil element, forming an implant subassembly.

51. In the implant subassembly according to claim 50, An implant subassembly comprising the helical coil element positioned at the distal end of the elongated flexible tubular member, the elongated flexible tubular member further comprising a flexible tube connected to the helical coil element and positioned proximal to the helical coil element.

52. In the implant subassembly according to claim 49, The aforementioned elongated, flexible tubular member comprises a flexible tube, and is an implant subassembly.

53. In the implant subassembly according to claim 49, The implant subassembly has a proximal end configured to lock into a handle subassembly.

54. In the implant subassembly according to claim 49, The implant subassembly has a proximal end that is sized and configured as follows: the proximal end of the implant subassembly is sized and configured to fit through the elongated tubular member of the handle subassembly into the handle of the handle subassembly.

55. In the implant subassembly according to claim 54, An implant subassembly wherein the proximal end of the implant subassembly is configured to lock in a predetermined position relative to the handle.

56. In the implant subassembly according to claim 55, The implant subassembly comprises a detachable component and a static component which are integrally connected in a first state when the proximal end of the implant subassembly is locked in a predetermined position relative to the handle, the detachable component being fixed to the first connecting member, the static component being fixed to the second connecting member, and the detachable component being adapted to be separated from the static component in a second state when the implant is released from the implant connecting mechanism.

57. In the implant subassembly according to claim 56, An implant subassembly in which the second connecting member is attached to the static component in a taut state.

58. In the implant subassembly according to claim 56, An implant subassembly comprising: a static component which is locked in a predetermined position relative to the handle; a detachable component which is adapted to be detached from the static component by moving the detachable component proximal to the static component, wherein the proximal movement of the detachable component moves the first connecting member proximal to release the implant from the implant coupling mechanism.

59. In the implant subassembly according to claim 54, The implant subassembly is configured such that the proximal end of the implant subassembly can fix the first connecting member to the handle in a predetermined position.

60. In the implant subassembly according to claim 59, The implant subassembly is characterized in that the first connecting member is axially movable relative to the second connecting member when an axial force is applied between the detachable component and the static component of the implant subassembly.

61. In the implant subassembly according to claim 59, An implant subassembly wherein the proximal end of the implant subassembly includes a region having a smaller outer dimension than an axially adjacent region, the smaller outer dimension being adapted to lock the proximal end of the implant subassembly in place relative to the handle.

62. In the implant subassembly according to claim 61, An implant subassembly wherein the region is a first region, and the proximal end of the implant subassembly includes a second region that is axially spaced from the first region and has a smaller outer dimension than an axially adjacent region, the smaller outer dimension of the second region being further adapted to lock the proximal end of the implant subassembly in a predetermined position relative to the handle.

63. In the implant subassembly according to claim 62, An implant subassembly comprising a detachable component including a first region and a static component including a second region, wherein the detachable component is fixed to a first connecting member, and the detachable component and the first connecting member are adapted to move proximal to the static component in order to release the implant from the implant connection mechanism.

64. In the implant subassembly according to claim 54, An implant subassembly having first and second recesses configured to fix the proximal end of the implant subassembly in a predetermined position relative to the handle of the handle subassembly.

65. An implant subassembly according to claim 49, Furthermore, the implant subassembly comprises an implant subassembly packaging in which a handle used for delivering the implant is not provided.

66. In the implant subassembly according to claim 49, The implant subassembly has at least one surface configured and sized to connect to the proximal end of a delivery catheter at its distal end.

67. In the implant subassembly according to claim 66, The implant subassembly wherein the distal end of the implant subassembly is the distal end of the cartridge.

Images