Implant delivery device and method of manufacture thereof - Patent application

Abstract

A method of assembling an apparatus for delivering an implant to a deployment site within a patient's vasculature includes the steps of: placing an implant engaging member at least partially within a lumen of a tubular structure, the tubular structure having a sidewall including a pattern of wires or struts; heating the implant engaging member; forcing at least a portion of the sidewall of the tubular structure radially inward into a surface of the implant engaging member, thereby causing the wires or struts of the sidewall to penetrate the surface and form corresponding recesses in the surface; and hardening the implant engaging member after forming the recesses in the surface of the implant engaging member.

Description

[Technical field]

[0001] The field of the disclosure relates to medical devices, and more particularly to delivery devices, such as delivery catheters for delivering implants, and methods of manufacturing the same. [Background technology]

[0002] Various implants may be delivered into a patient's body for therapeutic and / or diagnostic purposes. One type of implant is a stent, which is configured to be delivered into the patient's vasculature.

[0003] To deliver the stent, a pusher disposed within the delivery tube can be utilized to advance the stent distally relative to the delivery tube. The pusher must be capable of advancing the stent with a force that overcomes the frictional forces between the stent and the inner wall of the delivery tube. In some cases, if the coupling force between the pusher and the stent is too large, the stent may temporarily "stick" to the pusher after the stent is deployed out of the delivery tube, preventing the stent from quickly and efficiently detaching from the pusher.

[0004] Described herein are new delivery devices and techniques for delivering implants, such as stents, as well as new methods of manufacturing such delivery devices. Summary of the Invention

[0005] A method of assembling an apparatus for delivering an implant to a deployment site within a patient's vasculature includes the steps of: placing an implant engaging member at least partially within a lumen of a tubular structure, the tubular structure having a sidewall including a pattern of wires or struts; heating the implant engaging member; forcing at least a portion of the sidewall of the tubular structure radially inward into a surface of the implant engaging member, thereby causing the wires or struts of the sidewall to penetrate the surface and form corresponding recesses in the surface; and hardening the implant engaging member after forming the recesses in the surface of the implant engaging member.

[0006] Optionally, the implant engaging member is disposed within the lumen of the tubular structure prior to heating the implant engaging member.

[0007] Optionally, the implant engaging member is attached to a distal end portion of the elongate core member prior to being disposed within the lumen of the tubular structure.

[0008] Optionally, the wires or struts of the tubular structure are forced into the surface of the implant engaging member by axially stretching the tubular structure.

[0009] Optionally, the implant engaging member is cured while the wires or struts of the tubular structure remain at least partially located within recesses formed in a surface of the implant engaging member.

[0010] Optionally, the recesses formed in a surface of the implant engaging member substantially mirror the pattern of the wires or struts of at least a portion of the tubular structure.

[0011] Optionally, the implant engaging member is hardened to a hardness of at least 25A.

[0012] Optionally, the tubular structure is an implant and the wires or struts comprise braided wires.

[0013] Optionally, the tubular structure is an implant and the wires or struts include struts formed by laser cutting a tube.

[0014] Optionally, the tubular structure is a separate structure from the implant, and the wire or strut pattern is substantially identical to the wire or strut pattern of the implant.

[0015] Optionally, the method further comprises separating the tubular structure from the implant engaging member before hardening the implant engaging member.

[0016] Optionally, the method further includes the steps of separating the tubular structure from the implant engaging member and positioning at least a portion of the implant on the implant engaging member such that at least some of the wires or struts of the implant are located within respective recesses formed in a surface of the implant engaging member.

[0017] Optionally, the implant engaging member is heated using a sterile heat source.

[0018] Optionally, at least one of the recesses includes a groove that forms a non-zero angle with respect to an imaginary line parallel to the longitudinal axis of the implant engaging member.

[0019] Optionally, the heating step occurs before the forcing step.

[0020] Optionally, the heating step occurs after the forcing step.

[0021] Optionally, the method further comprises disposing the implant engaging member and the tubular structure within an introducer sheath to form at least a portion of the article, and the heating step is performed on at least a portion of the article.

[0022] A system for delivering an implant to a deployment site within a patient's vasculature, where the tubular implant has a sidewall including a pattern of wires or struts, includes an elongated core member and an implant engaging member coupled to a distal end portion of the elongated core member, the implant engaging member including a surface having a plurality of recesses formed therein, the recesses receiving and accommodating the wires or struts of a corresponding sidewall portion of the tubular implant, the recesses formed in the surface of the implant engaging member substantially mirroring the pattern of the wires or struts of the corresponding sidewall portion of the tubular implant.

[0023] Optionally, the wires or struts of the tubular implant comprise braided wires.

[0024] Optionally, the wires or struts of the tubular implant include struts formed by laser cutting a tube.

[0025] Optionally, the implant engaging member has a hardness of at least 25A.

[0026] Optionally, the system further includes an additional recess in a surface of the implant engaging member configured to receive at least a portion of a marker of the tubular implant.

[0027] Optionally, the system further includes a delivery catheter, wherein the elongate core member, implant engaging member and tubular implant are at least partially disposed within a lumen of the delivery catheter and are slidable relative to the delivery catheter, wherein the implant engaging member and delivery catheter are configured to cooperate with one another to grip the tubular implant as the elongate core member moves through the lumen of the delivery catheter, and wherein the tubular implant is configured to change from the compressed delivery configuration to the expanded deployed configuration with an expansion force substantially greater than the frictional force exerted by the recesses on the wires or struts of the implant engaging member when the tubular implant is no longer confined within the delivery catheter.

[0028] Other and further aspects and features will become apparent from a reading of the following detailed description. [Brief description of the drawings]

[0029] The drawings illustrate the design and utility of the embodiments, in which similar elements are commonly designated by reference numerals. The drawings are not necessarily drawn to scale. To better understand how the above-mentioned and other advantages and objects are obtained, a more particular description of the embodiments illustrated in the accompanying drawings is provided. The drawings depict merely exemplary embodiments, and therefore should not be considered as limiting the scope of the claims.

[0030] [Figure 1] FIG. 1 illustrates a medical device configured to deliver an implant, according to some embodiments. [Diagram 2] FIG. 2 illustrates the medical device of FIG. 1, particularly showing a portion of the implant being delivered outside of a catheter. [Diagram 3] FIG. 3 illustrates the medical device of FIG. 1, particularly showing the implant delivered entirely outside the catheter. [Figure 4] Figure 4A illustrates an implant engaging member engaging with an implant according to some embodiments. Figure 4B illustrates a cross-sectional view of the implant engaging member engaging with the implant of Figure 4A. [Diagram 5] Figure 5A shows the implant of Figure 4A, particularly showing the implant being detached from the implant engaging member, and Figure 5B shows a cross-sectional view of the implant engaging member of Figure 5A. [Figure 6] 6A-6D illustrate systems and techniques for manufacturing medical devices according to some embodiments. [Figure 7] FIG. 7 illustrates an implant engaging member and corresponding implant of a medical device according to another embodiment. [Figure 8] FIG. 8 illustrates a method of manufacturing a medical device according to some embodiments. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0031] Various embodiments will be described below with reference to the drawings. Please note that the drawings are not drawn to scale, and elements of similar structure or function are given the same reference numerals throughout the drawings. Please also note that the drawings are intended only to facilitate the description of the embodiments. They are not intended to be an exhaustive description of the invention or to limit the scope of the invention. Furthermore, the illustrated embodiment does not necessarily have all the aspects or advantages shown. An aspect or advantage described in connection with a particular embodiment is not necessarily limited to that embodiment, and may be implemented in any other embodiment, even if not so illustrated or explicitly described.

[0032] 1 illustrates a medical device 100 configured to deliver an implant, according to some embodiments. The medical device 100 includes an elongated structure (e.g., an elongated core member) 102 having a distal end 104 and a proximal end 106, an implant engaging member 110 coupled to the distal end 104 (e.g., a distal end portion) of the elongated structure, and a handle 120 coupled to the proximal end 106 of the elongated structure 102. The medical device 100 also includes a sheath 130 having a sheath distal end 132, a sheath proximal end 134, and a sheath body 136 extending between the sheath distal end 132 and the sheath proximal end 134. The sheath 130 has a lumen 138 for housing an implant 140 to be delivered into a patient's body.

[0033] In some embodiments, the sheath 130 may be part of a catheter (e.g., a microcatheter). In other embodiments, the sheath 130 may be a tube configured to package and house the implant 140. In such cases, the implant 140, along with the implant engaging member 110 and the elongated structure 102, may be transferred from the sheath 130 into a catheter (e.g., a microcatheter) during a medical procedure after the distal tip of the catheter is placed at a desired location within a patient's body. After advancement through the catheter, the implant 140 is deployed out of the distal end of the catheter.

[0034] 1, the implant engaging member 110 is disposed within a lumen 138 of the sheath 130 and is movable (e.g., translatable) relative to the sheath 130 along a longitudinal axis of the elongate member 102 in response to relative movement of the handle 120 relative to the sheath 130. Alternatively or additionally, the sheath 130 can be moved (e.g., translated) relative to the handle 120, thereby causing relative movement between the implant engaging member 110 and the sheath 130.

[0035] The implant engaging member 110 and the sheath 130 are configured to cooperate with one another to grasp and release the implant 140. In particular, as shown in FIG. 1, while the implant 140 is housed within the lumen 138 of the sheath 130, the proximal end 144 of the implant 140 is engaged with the implant engaging member 110 and becomes "grasped" between the implant engaging member 110 and the inner surface of the wall of the sheath 130.

[0036] As shown, the implant engaging member 110 is configured to engage an inner surface of the implant 140 when the implant 140 is housed within the sheath 130. In the illustrated embodiment, the implant engaging member 110 includes a surface and a number of grooves (e.g., groove 502 shown in FIGS. 4-5) disposed on the surface of the implant engaging member 110, the grooves forming a pattern that matches at least a portion of the braid pattern of the implant 140. This feature is advantageous because it allows the proximal end 144 of the implant 140 to be matingly engaged with the grooves on the surface of the implant engaging member 110. As a result, the proximal end 144 of the implant 140 is removably secured to the implant engaging member 110 via the grooves on the surface of the implant engaging member 110. In some embodiments, the implant 140 can include a braid that forms a braid pattern. In such a case, the grooves on the surface of the implant engaging member 110 form a pattern that matches the braid pattern of the implant 140. This allows at least a portion of some of the braid of implant 140 (e.g., portions of the braid at proximal end 144) to be received in respective grooves of implant engaging member 110. The grooves of implant engaging member 110 are described in further detail below.

[0037] 2, after the sheath distal end 132 of the sheath 130 is desirably positioned at a target location within the patient's body, at least a portion of the implant 140 (e.g., distal end 142 - shown in FIG. 1) can be deployed out of the sheath 130. This can be accomplished by moving the handle 120 distally relative to the sheath 130 and / or moving the sheath 130 proximally relative to the handle 120. The distal movement of the handle 120 and / or the proximal movement of the sheath 130 moves the implant engaging member 110 towards the distal end 132 of the sheath 130. As the implant engaging member 110 moves distally relative to the sheath 130, it carries the implant 140 with it, thereby moving the implant 140 distally relative to the sheath 130. Carriage of the implant 140 by the implant engaging member 110 is due to the fact that a portion of an implant component (e.g., a braid) of the implant 140 is at least partially disposed within a respective groove (e.g., groove 502 shown in FIGS. 4-5 ) of the implant engaging member 110. When a portion of the implant 140 is deployed out of the lumen 138 of the sheath 130, the portion of the implant 140 transitions from its delivery configuration to a deployed configuration as shown in FIG.

[0038] The delivery configuration of the implant 140 (or a portion of the implant 140) has a cross-sectional dimension that is smaller than the cross-sectional dimension of the deployed configuration of the implant 140 (or a portion of the implant 140). For example, as shown in FIG. 2, the majority of the implant 140 is deployed outside the sheath 130, but the proximal end 144 of the implant 140 remains within the lumen 138 of the sheath 130. The proximal end 144 is grasped between the sheath 130 and the implant engaging member 110 and has its delivery configuration while inside the sheath 130. The cross-sectional dimension of the proximal end 144 of the implant 140 in its delivery configuration within the lumen 138 of the sheath 130 is smaller than the cross-sectional dimension of one or more other portions of the implant 140 that are delivered outside the lumen 138 of the sheath 130.

[0039] In some cases, if the physician desires to change the position of the partially deployed implant 140 and / or adjust the configuration of the deployed implant 140, the physician can move the handle 120 proximally relative to the sheath 130. This causes the implant engaging member 110 to move proximally relative to the sheath 130. The proximal end 144 of the implant 140 is engaged with the groove on the surface of the implant engaging member 110 such that the proximal end 144 of the implant 140 is secured to the implant engaging member 110 via the groove on the surface of the implant engaging member 110. As a result, the proximal movement of the implant engaging member 110 relative to the sheath 130 retracts the deployed portion of the implant 140 back into the lumen 138 of the sheath 130, thereby causing said portion of the implant 140 to assume a delivery configuration within the sheath 130. In some cases, all of the previously deployed portion or portions of the implant 140 may be retracted back into the lumen 138 of the sheath 130. The physician may then reposition the sheath 130 to position the distal end 132 of the sheath 130 in a different location in order to redeploy a portion of the implant 140 .

[0040] In some cases, the implant 140 can be deployed entirely out of the lumen 138 of the sheath 130. Figure 3 illustrates the medical device of Figure 1, and in particular, the implant 140 being delivered entirely out of the sheath 130. As shown in Figure 3, once the proximal end 144 of the implant 140 is pushed out of the lumen 138 of the sheath 130 by the implant engaging member 110, the proximal end 144 of the implant 140 springs radially outward to transition from its delivery configuration to the deployed configuration. When in the deployed configuration, the implant 140 has a larger cross-sectional dimension than when the implant 140 is in the delivery configuration.

[0041] FIG. 4A illustrates the implant engaging member 110 engaged with an implant 400. The implant 400 may be an example of the implant 140 of FIG. 1. In FIG. 4A, the sheath 130 is not shown for clarity. As illustrated, the implant has multiple implant components 402. In the illustrated embodiment, the implant is a braided implant and the implant components 402 are braided elements (e.g., filaments, wires, strands, fibers, etc.). In other embodiments, the implant 400 may be other types of implants and the implant components 402 may be components for other types of implants. In the illustrated example, the implant 400 is in a delivery configuration while engaged with the implant engaging member 110 and housed within the sheath 130 (not shown). FIG. 4B illustrates a cross-section of the implant engaging member 110 engaged with the implant 400. The implant engaging member 110 includes a surface 500 having multiple grooves 502. The grooves 502 are configured to house the respective implant components 402 (e.g., braided elements) of the implant 400. In the illustrated embodiment, the grooves 502 form a pattern that matches at least a portion of the pattern (eg, a braided pattern) of the implant component 402 of the implant 140 .

[0042] 4B, the implant 140 includes a tubular structure (formed by the implant component 402) having an outer cross-sectional dimension. The cross-sectional dimension of the implant engaging member 110 is smaller than the outer cross-sectional dimension of the tubular structure of the implant 140. The tubular structure of the implant 140 (formed by the implant component 402) also has an inner cross-sectional dimension. Because the implant component 402 is at least partially received within the groove 502 of the engaging member 110, the inner cross-sectional dimension of the tubular structure of the implant 140 (i.e., when the implant 140 is circumferentially engaged with the implant engaging member 110) is smaller than the maximum cross-sectional dimension of the implant engaging member 110.

[0043] 4B, the implant component 402 is partially disposed within a respective groove 502 in the implant engaging member 110. In some embodiments, the depth of each groove 502 is at least 5% of the maximum thickness of the implant component 402. For example, if the implant 140 has a braided element (e.g., a single braided fiber or a group of braided fibers formed into an elongate member), the depth of each groove 502 is at least 5% of the thickness of the braided element of the implant. In other embodiments, the depth of each groove 502 can be at least 10%, at least 15%, at least 20%, at least 25%, at least 30%, at least 40%, at least 50%, at least 60%, at least 70%, at least 80%, or at least 90% (e.g., 100%) of the thickness of the implant component 402.

[0044] Additionally, in some embodiments, the width of the groove 502 (measured perpendicular to the longitudinal axis) may be less than the width of the implant component (e.g., braided element). In other embodiments, the width of the groove 502 may be the same as the width of the implant component. In further embodiments, the width of the groove 502 may be greater than the width of the implant component.

[0045] FIG. 5A illustrates the implant 400 of FIG. 4A, specifically showing the implant 400 disengaged from the implant engaging member 110. This occurs when the implant engaging member 110, which is coupled to the implant 400, exits the lumen 138 of the sheath 130, such that the implant 400 is no longer gripped between the sheath 130 and the implant engaging member 110. As shown, as the implant 400 expands to its deployed configuration, the implant components 402 form a pattern that no longer matches the pattern of grooves 502 on the surface 500 of the implant engaging member 110. FIG. 5B illustrates a cross-sectional view of the implant engaging member 110 of FIG. 5A, specifically showing the implant components 402 no longer positioned within the grooves 502.

[0046] In the illustrated embodiment, the implant engaging member 110 is made from a material that provides the implant engaging member 110 with sufficient hardness such that the implant component 402 (e.g., braided element) of the implant 400 does not "stick" to the groove 502 of the implant engaging member 110 and temporarily prevent the proximal end 144 of the implant 400 from being decoupled from the implant engaging member 110. For example, in some embodiments, the implant engaging member 110 can have a hardness of at least 25A, at least 30A, at least 40A, at least 50A, at least 60A, at least 70A, at least 80A, or more.

[0047] In some embodiments, the implant 140 is configured to change from the delivery configuration to the deployed configuration with an expansion force that is greater than the frictional force that the grooves 502 of the implant engaging member 110 exert on the implant 140. The expansion force can be greater than the gripping force by an amount sufficient to allow the proximal end 144 of the implant 140 to immediately snap open to the deployed configuration when the proximal end 144 of the implant 140 is not constrained by the sheath 130. In one embodiment, the implant engaging member 110 can be made of a deformable, flexible material such that the surface of the implant engaging member 110 can be indented by a tool pressed against it. The tool can also have a pattern of grooves formed in the surface of the implant engaging member 110. After the surface of the implant engaging member 110 is indented to form the grooves, the implant engaging member 110 can be temperature treated to permanently fix the indentations (grooves). For example, the implant engaging member 110 can be first heated to soften the implant engaging member 110, thereby allowing the grooves to be more easily formed. In some embodiments, a sterilization heat source can be utilized to apply heat to sterilize the implant engaging member 110 and / or the implant 140. In such cases, the heat for sterilization can be used to soften the implant engaging member 110 during the sterilization process. In other embodiments, a separate heat source can be utilized to heat the implant engaging member 110. After forming the grooves, the implant engaging member 110 can be cooled to harden the implant engaging member 110 with the grooves. In other embodiments, instead of or in addition to temperature treating to set the depressions and form permanent grooves, the implant engaging member 110 can be chemically treated, laser treated, or optically treated, or simply hardened by the passage of time. In some embodiments, the implant engaging member 110 can be made from a polymer, such as a thermoplastic polymer. In other embodiments, the implant engaging member 110 can be made from other materials.As used herein, the term "permanently fix" or other similar terms refers to any act of causing a depression / groove to take on a form or characteristic that is more permanent (e.g., making the object having the depression / groove harder) than before the act was performed. Similarly, the term "permanent groove" refers to a groove having a more permanent form compared to before making the object having the groove harder.

[0048] In other embodiments, the implant engaging member 110 can be 3D printed with permanent grooves by design. The groove pattern for the 3D print file can be obtained by scanning (e.g., a high resolution 3D scan) a pre-formed engaging member. For example, the pre-formed engaging member can be formed by indenting and temperature treating the surface of the implant engaging member 110 as described herein.

[0049] In the illustrated embodiment, at least one of the grooves 502 forms an angle greater than 0 degrees with respect to an imaginary line parallel to the longitudinal axis of the elongated structure 102. In other embodiments, one of the grooves 502 can form a first angle with respect to an imaginary line parallel to the longitudinal axis of the elongated structure 102, and another one of the grooves can form a second angle with respect to an imaginary line parallel to the longitudinal axis of the elongated structure 102. The first angle and the second angle can be the same. Alternatively, the first angle and the second angle can be different from one another. Also, in some embodiments, the pattern of the grooves 502 of the implant engaging member 110 can include a crisscross pattern. In other embodiments, the grooves 502 of the surface 500 of the implant engaging member 110 can form other patterns, such as a spiral pattern, a lattice pattern, a zigzag pattern, a user-defined pattern, a symmetrical pattern, an asymmetrical pattern, or the like.

[0050] It should be noted that providing the implant engaging member 110 with grooves 502 (wherein at least one of the grooves 502 forms an angle greater than 0 degrees with respect to an imaginary line parallel to the longitudinal axis of the elongated structure 102) is advantageous because it allows the implant engaging member 110 to more efficiently move the proximal end 144 of the implant 140 in a distal or proximal direction relative to the sheath 130. This is because if all of the grooves 502 are parallel to the longitudinal axis of the elongated structure 102 and all of the implant components are also parallel to the longitudinal axis, then an axial force applied in the direction of the longitudinal axis of the elongated structure 102 will be parallel to the extension of the grooves 502. In such a case, in order for the proximal end 144 of the implant 140 to be moved by the implant engaging member 110, the device 100 must rely on all frictional forces between the implant components of the implant 140 and the implant engaging member 110. On the other hand, if at least one of the grooves 502 and at least one corresponding one of the implant components are not parallel to the longitudinal axis of the elongated structure 102, an axial force applied in the direction of the longitudinal axis of the elongated structure 102 will have at least some force component that "pushes" against the implant component, thereby allowing the implant 140 to move more efficiently (with less frictional force between the implant 140 and the implant engaging member 110).

[0051] In some embodiments, the implant 140 may be a stent configured to be delivered into the vasculature of a patient. In other embodiments, the implant 140 may be a vaso-occlusive device configured to be placed in an aneurysm. In such cases, in addition to the implant 140 sprung radially away from its longitudinal axis upon deployment of the implant 140, the implant 140 also elastically assumes a three-dimensional configuration (e.g., by bending or flexing action). For example, in some embodiments, the implant 140 may be a braided tubular elongate member having a profile that follows the curvature of the sheath 130 when contained within the sheath 130. After the implant 140 is deployed out of the sheath 130, the braided tubular elongate member also assumes a relaxed three-dimensional configuration as the braided tubular elongate member expands radially away from the longitudinal axis of the braided tubular elongate member and the braided tubular elongate member bends to form a series of loops (e.g., open and / or closed loops). The relaxed three-dimensional configuration formed by the implant 140 is configured to at least partially fill the space within the aneurysm. In further embodiments, the implant 140 may be other types of implants.

[0052] As used herein, the term "relaxed three-dimensional configuration" of an implant refers to the three-dimensional configuration of the implant when the implant is not confined within a delivery tube (e.g., sheath 130). For example, the relaxed three-dimensional configuration of an implant may be the configuration of the implant when it is delivered into a patient's body or may be the configuration of the implant when it is resting freely on a surface outside the patient's body.

[0053] 6A-6D illustrate a system 550 and techniques for manufacturing a medical device according to some embodiments. The system 550 includes an object 600 formed as the implant engaging member 110. The system 550 also includes a tubular structure 602 having a braided pattern. In some embodiments, the tubular structure 602 can have the same properties as an implant (e.g., implant 140) or the tubular structure 602 can be an implant itself. In the illustrated embodiment, the tubular structure 602 can be a braided tubular structure made from multiple braided elements. To create the implant engaging member 110 with the grooves 502, the object 600 without the grooves 502 is first placed within the lumen of the tubular structure 602 (FIG. 6A). The tubular structure 602 can be stretched to collapse radially inward to engage the object 600 (FIG. 6B). Alternatively or additionally, the tubular structure 602 can be inserted into a sheath (e.g., sheath 130). The inner wall of the sheath exerts a force towards the tubular structure 602, thereby pushing the tubular structure inward to engage the object 600. The object 600 can have soft and / or deformable properties that allow the components of the tubular structure 602 (e.g., braided elements) to indent the surface of the object 600. After forming the indentations in the surface of the object 600, the object 600 can be temperature treated (e.g., by cooling source 610) to permanently fix the indentations and form grooves in the surface of the object 600. Alternatively or additionally, the object 600 can be chemically treated by one or more chemicals, laser treated by a laser device, or simply hardened over time, thereby fixing the grooves in the surface of the object 600.

[0054] In other embodiments, the object 600 may initially have relatively rigid properties. The object 600 may be placed on a mandrel for support by the mandrel. The tubular structure 602 is then placed over the object 600. The tubular structure 602 may be stretched and / or compressed to urge the tubular structure 602 towards the object 600. Alternatively or additionally, a tube (e.g., heat shrink tubing) may be placed over the tubular structure 602 to press the tubular structure 602 towards the object 600. When heat is applied to the object 600, the object 600 becomes softer (less rigid), thereby allowing the structural components of the tubular structure 602 to more easily indent the surface of the object 600. After forming the indentations (grooves), the object 600 is cooled to set the grooves.

[0055] The tubular structure 602 is then removed from the object 600 (FIG. 6C). As shown, the surface of the object 600 has grooves 620 formed therein. The grooves 620 have a pattern that matches the braid pattern of the tubular structure 602. The object 600 with the grooves 620 is then cut (e.g., by a mechanical cutter, a laser cutter, etc.) into pieces of the engagement members 110 (FIG. 6D).

[0056] In the above embodiment, the object 600 has an elongated configuration, which allows for simultaneous groove formation in multiple engagement members 110. In other embodiments, the object 600 can have a shorter configuration. For example, in other embodiments, the object 600 can have a length sufficient to form only one engagement member 110.

[0057] Also, in the above embodiment, the tubular structure 602 used to form the grooves 620 in the object 600 is not the implant that is delivered by any of the formed engagement members 110. Rather, the tubular structure 602 is used only during the manufacturing process to form the grooves 620 on the object 600. In one embodiment, the tubular structure 602 may be an implant that is originally manufactured for implantation purposes, but is then used instead in the manufacturing process to form the grooves in the implant engagement member 110. In such a case, the tubular structure 602 has the same characteristics as the implant. In other embodiments, the tubular structure 602 may not be the same as the implant, but may have certain characteristics that are the same as those of the implant. For example, in other embodiments, the tubular structure 602 may have a braid pattern or surface texture that is the same as that of the implant (when the implant is in a collapsed or delivery configuration against the formed implant engagement member 110).

[0058] In other embodiments, the tubular structure 602 used to form the groove 620 in the object 600 may be an implant that is coupled to the implant engaging member 110 to be formed. In one embodiment, the tubular structure 602 (the implant 140 in this example) is placed over the object 600. The object 600 is configured to form one engaging member 110 in this example, and thus has a length corresponding to the length of the implant engaging member 110 to be formed. The implant 140 may be stretched to collapse radially inward to engage the object 600. Alternatively or additionally, the implant 140 may be inserted into a sheath (e.g., the sheath 130) to allow the implant 140 to assume its delivery configuration, and the proximal end 144 of the implant 140 may be pushed radially inward to engage the object 600. The object 600 may have soft and / or deformable properties such that an implant component (e.g., a braided element) of the implant 140 may indent the surface of the object 600. Alternatively, the object 600 may be heated to soften the object 600 so that depressions can be formed in the surface of the object 600. In some embodiments, the object 600 and / or the implant 140 may be sterilized using a heat source that applies heat to the object 600 and / or the implant 140. In such cases, the heat from the sterilization process may be used to soften the object 600 in order to form depressions in the surface of the object 600. Also, in some embodiments, the heating of the object 600 may be performed in a finished configuration where the implant 140 is coupled to the object 600 (the engagement member) and within the introducer sheath. Alternatively, instead of using a sterilization heat source, a separate heat source may be used to apply heat to the object 600. After the depressions are formed in the surface of the object 600, the object 600 may be treated to permanently fix the depressions and form grooves in the surface of the object 600 (which will become the implant engagement member 110).

[0059] It should be noted that, in order to form a pattern of grooves 502 on the surface of the implant engaging member 110 that matches the pattern of the implant component 402 (e.g., braided elements) of the implant 400, the pattern of the depression elements (for forming depressions in the object 600) in the tubular structure 602 should be the same as the pattern of the implant component 402 of the implant 400 when the implant 400 is in its collapsed (delivery) configuration (e.g., when collapsed to engage with the implant engaging member 110).

[0060] 6, the tubular structures 602 have a lattice pattern. In other embodiments, the tubular structures 602 can have other configurations. For example, in other embodiments, the structures 602 can have a spiral pattern, a lattice pattern, a zigzag pattern, a user-defined pattern, a symmetrical pattern, an asymmetrical pattern, etc. In some embodiments, any of such patterns can correspond to at least a portion of the pattern formed by the implant component 402 of the implant 400.

[0061] Also, in the above embodiment, the implant engaging member 110 has been described as having a groove. However, the feature of the implant engaging member 110 is not limited to a groove. In other embodiments, the implant engaging member 110 can have any recess or indentation, and the recess or indentation can have any size and / or shape. FIG. 7 illustrates another example of an implant engaging member 110 and a corresponding implant 140 according to another embodiment. As illustrated, the implant 140 is a stent having a number of markers 702 at one end and a number of struts 704 extending from the stent body and connecting with the markers 702. The implant engaging member 110 has a recess (e.g., a recess or indentation) 502 configured to receive each component of the implant 140. The recess 502 has a respective geometry (e.g., size, shape, position, or any combination thereof) corresponding to each component of the implant. The recess 502 includes a depression 712 configured to receive a respective marker 702 of the implant 140 and a depression 714 configured to receive a respective strut 704 of the implant 140. As shown, the depression 712 has a shape and size corresponding to the shape and size of the marker 702. Similarly, the depression 714 has a shape and size corresponding to the shape and size of the strut 704. Additionally, the depressions 712, 714 form a pattern that matches the pattern of the markers and struts 704. This allows the implant engaging member 110 to receive the implant 140 in a mating configuration. It should be noted that grooves, depressions, and recesses are all examples of "recesses."

[0062] 8 illustrates a method 800 of manufacturing a medical device according to some embodiments. In the illustrated embodiment, the medical device has an elongate structure and an implant engaging member coupled to a distal end portion of the elongate structure. The medical device may optionally further include a sheath surrounding the implant engaging member and the elongate structure, and / or a handle coupled to a proximal end of the elongate structure. In some embodiments, the medical device may be device 100 of FIG. 1, or any component or combination of components of device 100. The method 800 includes disposing an implant engaging member at least partially within a lumen of a tubular structure, the tubular structure having a sidewall including a pattern of wires or struts (item 802), heating the implant engaging member (item 804), forcing at least a portion of the sidewall of the tubular structure radially inward into a surface of the implant engaging member, thereby causing the wires or struts of the sidewall to penetrate the surface and form corresponding recesses in the surface (item 806), and hardening the implant engaging member after the recesses are formed in the surface of the implant engaging member (item 808). Hardening of the object can be achieved by cooling, chemical, laser, or over time.

[0063] Optionally, in method 800, an implant engaging member is disposed within the lumen of the tubular structure prior to heating the implant engaging member.

[0064] Optionally, in method 800, an implant engaging member is attached to a distal end portion of the elongate core member prior to being disposed within the lumen of the tubular structure.

[0065] Optionally, in method 800, axially stretching the tubular structure forces wires or struts of the tubular structure into the surface of the implant engaging member.

[0066] Optionally, in method 800, the implant engaging member is cured while the wires or struts of the tubular structure remain at least partially located within recesses formed in a surface of the implant engaging member.

[0067] Optionally, in method 800, recesses formed in a surface of the implant engaging member substantially mirror the pattern of wires or struts of at least a portion of the tubular structure.

[0068] Optionally, in method 800, the implant engaging member is hardened to a hardness of at least 25A.

[0069] Optionally, in method 800, the tubular structure is an implant and the wires or struts comprise braided wires.

[0070] Optionally, in method 800, the tubular structure is an implant and the wires or struts include struts formed by laser cutting a tube.

[0071] Optionally, in method 800, the tubular structure is a separate structure from the implant, and the wire or strut pattern is substantially identical to the wire or strut pattern of the implant.

[0072] Optionally, the method 800 further includes separating the tubular structure from the implant engaging member before hardening the implant engaging member.

[0073] Optionally, method 800 further includes the steps of separating the tubular structure from the implant engaging member and positioning at least a portion of the implant on the implant engaging member such that at least a portion of the wires or struts of the implant are located within respective recesses formed in a surface of the implant engaging member.

[0074] Optionally, in method 800, the implant engaging member is heated using a sterile heat source.

[0075] Optionally, in method 800, at least one of the recesses includes a groove that forms a non-zero angle with respect to an imaginary line parallel to the longitudinal axis of the implant engaging member.

[0076] Optionally, in method 800, a heating step occurs before or after the pushing step.

[0077] Optionally, method 800 further includes disposing the implant engaging member and the tubular structure within an introducer sheath to form at least a portion of the article, and the heating step is performed on at least a portion of the article.

[0078] Optionally, in method 800, the tubular structure is an implant that forms a recess in a surface of an object, and is also configured to be delivered by a medical device.

[0079] Optionally, in method 800, the medical device is configured to deliver an implant, and the tubular structure and the implant are separate devices.

[0080] Optionally, in method 800, the tubular structure for forming recesses in a surface of the implant engaging member can have a spiral pattern, a lattice pattern, a zigzag pattern, a user-defined pattern, a symmetrical pattern, an asymmetrical pattern, etc. In some embodiments, any such pattern can correspond to at least a portion of a pattern formed by an implant component of the implant.

[0081] Optionally, in method 800, the recesses created include respective geometric shapes corresponding to respective components (portions) of the implant. In some embodiments, the implant components may be strands of the implant braid. In other embodiments, the implant components may be markers of the implant. In further embodiments, the implant components may be struts of the stent. In further embodiments, the implant may be a stent having multiple markers (e.g., three markers) circumferentially disposed at the ends of the stent. In such cases, the recesses created in the method have respective geometric shapes corresponding to the markers. For example, one of the recesses may have a shape, size, and / or location corresponding to the shape, size, and / or location of one of the markers of the stent.

[0082] In the above embodiments, device 100 has been described as having a sheath 130, an implant engaging member 110, and an elongate structure 102. In other embodiments, device 100 may not include all of these components. For example, in other embodiments, device 100 may not include a sheath 130. In further embodiments, device 100 may not include an elongate structure 102. Thus, the term "device" is not necessarily limited to a complete product, but may refer to one or more portions of a product, or one or more portions of a design.

[0083] In one or more embodiments described herein, the device 100 may optionally further include a layer disposed on the interior surface of the sheath 130. This layer may be made of Teflon or other material that provides a smooth, low-friction surface that allows the implant 140 to "glide" on. In some cases, this layer may be considered part of the sheath 130.

[0084] Also, in one or more embodiments described herein, the device 100 may optionally further include a steerable mechanism for steering the distal end 132 of the sheath 130. For example, the device 100 may include one or more steering wires contained within the wall of the sheath 130. One or more distal ends of the one or more steering wires are coupled to the distal end 132 of the sheath 130. In use, one or more proximal ends of the one or more steering wires may be pulled by a manual control located on the handle 120, thereby bending the distal end 132 of the sheath 130. In some cases, when the device 100 has multiple steering wires, one or more of the steering wires may be selectively pulled to steer the distal end 132 of the sheath 130 in a desired direction. The steerability of the sheath 130 allows the distal end 132 of the sheath 130 to be steered through one or more curved passages within a patient's body, such as tortuous blood vessels, to reach a target location. In other embodiments, the device 100 may not include steering wires.

[0085] Additionally, in some embodiments, at least one of the grooves 502 of the implant engaging member 110 can be configured to mate with at least a portion of a marker of the implant. In particular, in some embodiments, the proximal end 144 of the implant 140 can include a marker. In such a case, when forming the grooves 502 in the implant engaging member 110, one of the grooves 502 can be formed to accommodate at least a portion of the marker of the implant 140.

[0086] The following items are exemplary features of the embodiments described herein. Each item may be an embodiment in itself or a part of an embodiment. One or more items described below may be combined with one or more other items in an embodiment.

[0087] Item 1: A method of assembling an apparatus for delivering an implant to a deployment site within a patient's vasculature includes the steps of: disposing an implant engaging member at least partially within a lumen of a tubular structure, the tubular structure having a sidewall including a pattern of wires or struts; heating the implant engaging member; forcing at least a portion of the sidewall of the tubular structure radially inward into a surface of the implant engaging member, thereby causing the wires or struts of the sidewall to penetrate the surface and form corresponding recesses in the surface; and hardening the implant engaging member after forming the recesses in the surface of the implant engaging member.

[0088] Item 2: In the method, the implant engaging member is disposed within the lumen of the tubular structure prior to heating the implant engaging member.

[0089] Item 3: In the method, an implant engaging member is attached to a distal end portion of the elongate core member prior to being disposed within the lumen of the tubular structure.

[0090] Item 4: In this method, the wires or struts of the tubular structure are forced into the surface of the implant engaging member by axially stretching the tubular structure.

[0091] Item 5: In the method, the implant engaging member is cured while the wires or struts of the tubular structure remain at least partially positioned within recesses formed in a surface of the implant engaging member.

[0092] Item 6: In the method, the recesses formed in the surface of the implant engaging member substantially mirror the pattern of the wires or struts of at least a portion of the tubular structure.

[0093] Item 7: In the method, the implant engaging member is hardened to a hardness of at least 25A.

[0094] Item 8: The method, wherein the tubular structure is an implant and the wires or struts comprise braided wires.

[0095] Item 9: In the method, the tubular structure is an implant and the wires or struts include struts formed by laser cutting a tube.

[0096] Item 10: In the method, the tubular structure is a separate structure from the implant, and the wire or strut pattern is substantially identical to the wire or strut pattern of the implant.

[0097] Item 11: The method further includes separating the tubular structure from the implant engaging member before hardening the implant engaging member.

[0098] Item 12: The method, further comprising the steps of separating the tubular structure from the implant engaging member and positioning at least a portion of the implant on the implant engaging member such that at least some of the wires or struts of the implant are located within respective recesses formed in a surface of the implant engaging member.

[0099] Item 13: In the method, the implant engaging member is heated using a sterile heat source.

[0100] Item 14: The method, wherein at least one of the recesses includes a groove that forms a non-zero angle with respect to an imaginary line parallel to a longitudinal axis of the implant engaging member.

[0101] Item 15: In the method, the heating step occurs before the pushing step.

[0102] Item 16: In this method, the heating step is performed after the pushing step.

[0103] Item 17: The method further includes disposing the implant engaging member and the tubular structure within an introducer sheath to form at least a portion of the article, and a heating step is performed on at least a portion of the article.

[0104] Item 18: A system for delivering an implant to a deployment site within a patient's vasculature, comprising an elongate core member and an implant engaging member coupled to a distal end portion of the elongate core member, the implant engaging member including a surface having a plurality of recesses formed therein, the recesses receiving and accommodating the wires or struts of a corresponding sidewall portion of the tubular implant, the recesses formed in the surface of the implant engaging member substantially mirroring the pattern of the wires or struts of the corresponding sidewall portion of the tubular implant.

[0105] Item 19: In this system, the wires or struts of the tubular implant include braided wires.

[0106] Item 20: In this system, the wires or struts of the tubular implant include struts formed by laser cutting a tube.

[0107] Item 21: In the system, the implant engaging member has a hardness of at least 25A.

[0108] Item 22: The system further includes an additional recess provided in a surface of the implant engaging member configured to receive at least a portion of a marker of the tubular implant.

[0109] Item 23: The system further includes a delivery catheter, wherein the elongated core member, the implant engaging member and the tubular implant are at least partially disposed within a lumen of the delivery catheter and are slidable relative to the delivery catheter, wherein the implant engaging member and the delivery catheter are configured to cooperate with one another to grip the tubular implant as the elongated core member moves through the lumen of the delivery catheter, and wherein the tubular implant is configured to change from the compressed delivery configuration to the expanded deployed configuration with an expansion force substantially greater than the frictional force exerted by the recesses on the wires or struts of the implant engaging member when the tubular implant is no longer confined within the delivery catheter.

[0110] Item 24: A medical device for delivering an implant includes an elongate structure having a distal end and a proximal end, and an implant engaging member coupled to the distal end of the elongate structure, the implant engaging member including a surface having a plurality of grooves, the grooves forming a pattern that matches at least a portion of the braid pattern of the implant.

[0111] Item 25: In the medical device, at least one of the grooves forms an angle greater than 0 degrees with respect to an imaginary line parallel to the longitudinal axis of the elongated structure.

[0112] Item 26: In the medical device, the pattern of grooves in the implant engaging member includes a cross pattern.

[0113] Item 27: In the medical device, the implant engaging member has a hardness of at least 25A.

[0114] Item 28: In the medical device, the implant engaging member is configured to engage an inner surface of the implant while the groove receives a braided element of the implant.

[0115] Item 29: In the medical device, one of the grooves of the implant engaging member is configured to receive at least a portion of the implant marker.

[0116] Item 30: In a medical device, the groove comprises a permanent depression.

[0117] Item 31: A medical device in which an implant includes a tubular structure having an outer cross-sectional dimension, and a cross-sectional dimension of an implant engaging member is smaller than the outer cross-sectional dimension of the tubular structure.

[0118] Item 32: The medical device further includes a sheath having a lumen, the implant engaging member being disposed within the lumen of the sheath.

[0119] Item 33: In the medical device, the implant engaging member and the sheath are configured to cooperate with one another to grasp and release the implant.

[0120] Item 34: The medical device further includes an implant, the implant having a delivery configuration when confined within the lumen of the sheath and a deployed configuration when outside the lumen of the sheath.

[0121] Item 35: In the medical device, the implant is configured to change from the delivery configuration to the deployed configuration with an expansion force greater than the frictional force exerted on the implant by the grooves.

[0122] Item 36: In a medical device, the expansion force is greater than the gripping force by a sufficient amount to allow the implant to immediately snap open to the deployed configuration when the implant is not constrained by a sheath.

[0123] Item 37: A method of manufacturing a medical device having an elongate structure and an implant engaging member coupled to a distal end portion of the elongate structure includes the steps of holding an object formed as the implant engaging member, placing a tubular structure over the object or inserting the object into the tubular structure, the tubular structure having a braided pattern, pressing the tubular structure radially inward toward the object to form grooves in a surface of the object, the formed grooves forming a pattern that corresponds to at least a portion of the braided pattern of the tubular structure, and hardening the object after forming the grooves in the surface of the object.

[0124] Item 38: In the method, the tubular structure is an implant.

[0125] Item 39: In the method, the implant is for forming a groove in a surface of an object and is also configured to be delivered by a medical device.

[0126] Item 40: In the method, the medical device is configured to deliver the implant, and the tubular structure and the implant are separate devices.

[0127] Item 41: In this method, the object has a hardness of at least 25A.

[0128] Item 42: The method further includes the step of heating the object using a sterilizing heat source or a separate heat source different from the sterilizing heat source.

[0129] Item 43: A system for making a medical device having an elongate structure and an implant engaging member coupled to a distal end portion of the elongate structure includes an object formed as the implant engaging member and a tubular structure having a braided pattern, the tubular structure configured to be pressed against the object to form grooves in a surface of the object, the grooves forming a pattern corresponding to the braided pattern of the tubular structure.

[0130] Item 44: In this system, the tubular structure is an implant.

[0131] Item 45: In the present system, the tubular structure is distinct from the implant.

[0132] As used herein, the term "surface" may refer to a real or imaginary surface, which may be curved or rectilinear, and is not limited to planar items that are continuous curves or straight lines, but may refer to any item that has points that define a surface or that lie on a surface.

[0133] Also, as used herein, the term "recess" may refer to a depression or dent in a surface formed by indenting or recessing a portion of the surface, or may refer to a depression or dent on a surface formed by any of the other techniques including, but not limited to, molding, 3D printing, and the like. For example, an object may be formed to have a recess using a mold, or an object with a recess may be created by 3D printing. Also, the term "recess" may refer to an elongated depression or dent, such as a groove (e.g., a channel), or a depression or dent having any size and / or shape.

[0134] Additionally, as used herein, the terms "apparatus," "device," and "system" may refer to a product, one or more components, a portion of a product, or a portion of a component. In some cases, any of these terms may refer to two or more components that are coupled to each other and / or have a functional and / or positional relationship to each other. Also, in some cases, the terms are synonymous with each other.

[0135] Additionally, as used herein, the term "distal end" of an item (e.g., an elongated structure, an elongated core member, etc.) may refer to any portion of such item that is within 1 / 3 of the total length of the item as measured from the distal tip of the item. Similarly, the term "proximal end" of an item (e.g., an elongated structure, an elongated core member, etc.) may refer to any portion of such article that is within 1 / 3 of the total length of the item as measured from the proximal tip of such item. The term "distal end portion" of an item may refer to any portion of the distal end of the item.

[0136] While particular embodiments have been disclosed and described, it is not intended to limit the claimed invention to the preferred embodiments, and it will be apparent to those skilled in the art that various changes and modifications can be made without departing from the scope of the claimed invention. For this reason, the specification and drawings are to be regarded in an illustrative sense, rather than a restrictive sense. The claimed invention is intended to cover alternatives, modifications and equivalents.

Claims

1. 1. A method of assembling an apparatus for delivering an implant to a deployment site within a patient's vasculature, comprising: disposing an implant engaging member at least partially within a lumen of a tubular structure, the tubular structure having a sidewall including wires forming a pattern; heating the implant engaging member; forcing at least a portion of a sidewall of the tubular structure radially inwardly into a surface of the implant engaging member, thereby causing a wire of the sidewall to penetrate into the surface to form a recess in the surface, the recess including a first recess and a second recess, the wire including a first wire portion and a second wire portion forming the first recess and a third wire portion extending from the first recess to form the second recess; and then curing the implant engaging member after forming recesses in a surface of the implant engaging member.

2. The method of claim 1, characterized in that the implant engaging member is positioned within the lumen of the tubular structure prior to the step of heating the implant engaging member.

3. The method of claim 1, characterized in that the implant engaging member is attached to a distal end portion of an elongated core member prior to placement within the lumen of the tubular structure.

4. The method of claim 1, characterized in that the wire of the tubular structure is pushed into the surface of the implant engaging member by axially extending the tubular structure.

5. A method as described in claim 1, characterized in that the implant engaging member is hardened while the tubular structure wire is at least partially positioned within the recess formed in the surface of the implant engaging member.

6. The method of claim 1, further comprising hardening the implant engaging member to a hardness of at least 25A.

7. The method of claim 1, wherein the tubular structure is the implant and the wire comprises a braided wire.

8. The method of claim 1, wherein the tubular structure is the implant and the wire comprises struts formed by laser cutting a tube.

9. The method of claim 1, wherein the tubular structure is a structure separate from the implant, the implant including an implant wire.

10. The method of claim 9, further comprising the step of separating the tubular structure from the implant engaging member prior to hardening the implant engaging member.

11. The method of claim 9, further comprising the steps of separating the tubular structure from the implant engaging member and positioning at least a portion of the implant onto the implant engaging member such that implant wires, which are at least a portion of the implant, are positioned within respective recesses formed in the surface of the implant engaging member.

12. The method of claim 1, further comprising heating the implant engaging member using a sterile heat source.

13. The method of claim 1, wherein at least one recess includes a groove that forms an angle other than 0 degrees with respect to an imaginary line parallel to the longitudinal axis of the implant engaging member.

14. The method of claim 1, wherein the machining step is performed before the pushing step.

15. The method of claim 1, wherein the machining step is performed after the pushing step.

16. The method of claim 1, further comprising the step of placing the implant engaging member and the tubular structure within an introducer sheath to form at least a portion of a product, wherein a heating step is performed on at least a portion of the product.

17. A system for delivering an implant to a deployment site within a patient's vasculature, comprising: a tubular implant having a sidewall including wires forming a pattern; The system further comprises: An elongated core member; an implant engaging member connected to a distal end portion of the elongate core member; 11. A system comprising: the implant engaging member including a recess having a plurality of recesses formed therein, the recesses receiving and accommodating a wire of a corresponding sidewall portion of the tubular implant, the recesses formed in a surface of the implant engaging member including a first recess and a second recess, the wire including a first wire portion and a second wire portion disposed within the first recess and a third wire portion disposed within the second recess extending from the first recess.

18. The system of claim 17, wherein the wire of the tubular implant comprises a braided wire.

19. The system of claim 17, wherein the wire of the tubular implant includes struts formed by laser cutting a tube.

20. The system of claim 17, wherein the implant engaging member has a hardness of at least 25A.

21. The system of claim 17, further comprising an additional recess in a surface of the implant engaging member configured to accommodate at least a portion of a marker of the tubular implant.

Images