Medical device delivery member having positioning window - Patents.com

Abstract

A delivery member for delivering and deploying an endovascular medical device is provided. The delivery member includes a flexible distal portion including a wound wire coil surrounded by a flexible sleeve and prevented from extending longitudinally by a support tube positioned through the lumen of the coil. The delivery member may include a stretch resistant member and hypotubes positioned on either side (distal and proximal) from the wound wire coil to which the wound wire coil may be attached. The distal hypotube may include attachment slots for positioning and attaching loop wires to the distal hypotube. The distal hypotube may further include one or more tube windows for visualizing proper placement of the support tube within the lumen of the distal hypotube.

Description

[Technical field]

[0001] (CROSS REFERENCE TO RELATED APPLICATIONS) This application is a continuation-in-part of U.S. patent application Ser. No. 16 / 749,578, filed Jan. 22, 2020, and claims priority under 35 U.S.C. § 120, the entire contents of which are incorporated herein by reference in their entirety.

[0002] FIELD OF THEINVENTION The present invention relates generally to an intravascular medical device system that is navigable through the body vasculature of a human subject. More specifically, the present invention relates to a delivery system and delivery members for delivering and deploying an implantable medical device to a target location in the body vasculature, and methods of use thereof. [Background technology]

[0003] The use of catheter delivery systems to position and deploy therapeutic devices (e.g., dilatation balloons, stents, and embolic coils) in the vasculature of the human body has become a standard procedure for treating endovascular diseases. Such devices have proven to be particularly effective when treating areas where traditional surgical procedures are not possible or pose a great risk to the patient, such as treating aneurysms in cerebral blood vessels. Due to the delicate tissues, such as brain tissue, surrounding cerebral blood vessels, performing surgical procedures to treat defects in cerebral blood vessels can be very difficult and often dangerous. Advances in catheter-based implant delivery systems have provided alternative treatments in such cases. Advantages of catheter delivery systems include providing a method for treating blood vessels with an approach that has been shown to reduce the risk of trauma to the surrounding tissue, and further enabling the treatment of blood vessels that were previously considered inoperable.

[0004] Generally, these procedures involve inserting a delivery catheter into the patient's vasculature and guiding it through the vasculature to a predetermined delivery site. A vaso-occlusive device, such as an embolic coil, can be attached to an implant engagement / deployment system (equivalently referred to herein as an "engagement system" or "deployment system") at the distal end of a delivery member (e.g., a microcatheter), which pushes the coil through the delivery catheter and out the distal end of the delivery catheter to the delivery site. Exemplary delivery members and engagement / deployment systems are described in U.S. Pat. Nos. 10,806,462, 10,806,461, and 11,207,494, each of which is incorporated herein by reference.

[0005] Some of the difficulties associated with properly performing such treatment procedures include ensuring that the delivery member and engagement system remain in a stable position throughout the treatment. For example, in some aneurysm treatment applications, as the aneurysm becomes increasingly filled with embolic material, the delivery member may tend to move due to increasing pushback from the embedded embolic material. If the delivery member moves during treatment, the physician may not be able to precisely control the placement of the embolic material and may choose to stop filling the aneurysm. In such instances, the aneurysm may not be fully filled, which may result in recanalization. Additionally, excessive movement or stretching of the delivery member and / or the associated engagement system may result in premature detachment of the embolic coil. Summary of the Invention [Problem to be solved by the invention]

[0006] Thus, a need exists for improved methods, devices, and systems for providing implant delivery members and implant engagement systems with improved stability. [Means for solving the problem]

[0007] It is an object of the present invention to provide systems, devices and methods that meet the above-mentioned needs.In general, it is an object of the present invention to provide a delivery member for delivering and deploying an implantable medical device having a flexible distal portion.

[0008] The stiffness of the distal portion of the delivery member can cause a microcatheter used to deliver embolic material to be pulled back from the aneurysm as the distal end of the delivery member is advanced through tortuous distal anatomy. If the microcatheter is pulled back while advancing embolic material, the microcatheter can be allowed to exit the aneurysm, potentially allowing the physician to lose control of the embolic coil, and may not be able to precisely control the placement of the embolic material and complete the treatment.

[0009] Flexibility can be provided by incorporating a length of coil wound along the distal portion of the delivery member. The wound coil can be protected by a flexible polymer sleeve positioned around the outside of the coil. The wound coil can prevent stretching of stretch-resistant tubing attached to the hypotube at either end of the wound coil.

[0010] An exemplary delivery member for delivering an implantable medical device to a target location in a body vessel can include a proximal hypotube, a support coil section, a distal hypotube, and an engagement system. The support coil section can be attached to a distal end of the proximal hypotube. The distal hypotube, the support coil section, and the proximal hypotube can form a continuous tubular structure having a lumen therethrough. The distal hypotube can have a distal end shaped to receive the implantable medical device. The distal hypotube can include a first attachment slot extending from the lumen to an outer surface of the distal hypotube. The distal hypotube can include a second attachment slot extending from the lumen to an outer surface of the distal hypotube. The engagement system can be movable to engage and deploy the implantable medical device. The engagement system can include a loop wire and a pull wire. The loop wire can extend through an opening in the implantable medical device to engage the engagement system with the implantable medical device. The loop wire can have a first end and a second end. The first end may extend at least partially through the first mounting slot and the second end may extend at least partially through the second mounting slot. The pull wire may extend through the lumen to engage the loop wire to engage the engagement system with the implantable medical device. The pull wire may be moved to retract proximally to disengage the loop wire to deploy the implantable medical device.

[0011] The first mounting slot can have a distal end and a proximal end. The proximal end can have a first diameter and the distal end can have a second diameter. The first diameter of the first mounting slot can be larger than the second diameter of the first mounting slot. Similarly, the second mounting slot can have a distal end and a proximal end. The proximal end can have a first diameter and the distal end can have a second diameter. The first diameter of the second mounting slot can be larger than the second diameter of the second mounting slot.

[0012] The delivery member may further include a first attachment connecting a first end of the loop wire to the first mounting slot and a second attachment connecting a second end of the loop wire to the second mounting slot.

[0013] The loop wire may be a metallic material and the first attachment and / or the second attachment may be a weld.

[0014] The first attachment and / or the second attachment may include an epoxy.

[0015] The first attachment can be a first knot in the loop wire having a knot diameter approximately equal to the first diameter of the first mounting slot, and the second attachment can be a second knot in the loop wire having a diameter approximately equal to the first diameter of the second mounting slot.

[0016] The loop wire may be a polymeric material.

[0017] The distal hypotube can have a helical cut along its longitudinal axis through the lumen.

[0018] The first mounting slot can be disposed on the distal hypotube opposite the second mounting slot along a diameter line passing through the longitudinal axis, and the first mounting slot can be disposed proximal to the second mounting slot by a distance equal to half the pitch of the helical cut.

[0019] The first mounting slot can be located at a first location equidistant from two adjacent gaps in the helical cut. The second mounting slot can be located at a second location equidistant from two adjacent gaps in the helical cut.

[0020] The first mounting slot and the second mounting slot may be perpendicular to the longitudinal axis.

[0021] An exemplary distal hypotube for a delivery member can have a distal end shaped to receive an implantable medical device. The distal hypotube can have a lumen extending therethrough. The distal hypotube can include a first attachment slot extending from the lumen to an outer surface of the distal hypotube. The distal hypotube can include a second attachment slot extending from the lumen to the outer surface. The distal hypotube can have a loop wire. The loop wire can be attached at a first end to the first attachment slot and at a second end to the second attachment slot. The distal hypotube can have a helical cut in the outer surface. The helical cut can be cut along a longitudinal axis through the lumen.

[0022] The first mounting slot can have a distal end and a proximal end. The proximal end of the first mounting slot can have a larger diameter than the distal end of the first mounting slot. The second mounting slot can have a distal end and a proximal end. The proximal end of the second mounting slot can have a larger diameter than the distal end of the second mounting slot. A loop wire can be attached to the first mounting slot by a first attachment. A loop wire can be attached to the second mounting slot by a second attachment.

[0023] The loop wire may be a metallic material and the first attachment and / or the second attachment may be a weld.

[0024] The first attachment and / or the second attachment may include an epoxy.

[0025] The first attachment can be a first knot in the loop wire having a knot diameter approximately equal to the first diameter of the first mounting slot, and the second attachment can be a second knot in the loop wire having a diameter approximately equal to the first diameter of the second mounting slot.

[0026] The first mounting slot can be disposed on the distal hypotube opposite the second mounting slot along a diameter line passing through the longitudinal axis, and the first mounting slot can be positioned proximal of the second mounting slot by a distance approximately equal to half the pitch of the helical cut.

[0027] An exemplary method for mounting an implantable medical device on a delivery member includes providing a delivery member. The delivery member can include a flexible distal hypotube. The method can include threading a first end of a loop wire through a proximal end of a first mounting slot of the flexible distal hypotube. The method can include pulling the first end of the loop wire from the proximal end of the first mounting slot toward a distal end of the first mounting slot having a smaller diameter than the proximal end. The method can include mounting the loop wire in the first mounting slot. The method can include threading a second end of the loop wire through a proximal end of a second mounting slot of the flexible distal hypotube. The method can include pulling the second end of the loop wire from the proximal end of the second mounting slot toward a distal end of the second mounting slot having a smaller diameter than the proximal end. The method can include mounting the loop wire in the second mounting slot.

[0028] Attaching the loop wire to the first mounting slot may include welding the loop wire into the first mounting slot.

[0029] The method can include tying a first knot on a first end of the loop wire prior to pulling the first end of the loop wire from a proximal end of the first mounting slot toward a distal end of the first mounting slot, and tying a second knot on a second end of the loop wire prior to pulling the second end of the loop wire from a proximal end of the second mounting slot toward a distal end of the second mounting slot.

[0030] An exemplary delivery member can include a distal hypotube. The distal hypotube can have a distal end shaped to receive an implantable medical device. The distal hypotube can have a longitudinal axis from the distal end to the proximal end of the distal hypotube. The distal hypotube can have a first tube window extending from the lumen of the distal hypotube to an outer surface of the distal hypotube. The first tube window can have a length greater than a width, the length being along the longitudinal axis. The delivery member can have a support tube positioned within the lumen of the distal hypotube.

[0031] The distal end of the support tube may be disposed within the length of the first tube window and positioned so as to be visible on the exterior of the distal hypotube.

[0032] The delivery member can have a loop wire extending through an opening in the implantable medical device. The delivery member can have a pull wire extending through the lumen engaged to the loop wire and movable to retract proximally to disengage the loop wire to deploy the implantable medical device.

[0033] The distal hypotube can include a first attachment slot extending from a lumen of the distal hypotube to an outer surface of the distal hypotube. A first end of the loop wire can extend at least partially through the first attachment slot.

[0034] The distal hypotube can include a second attachment slot extending from the lumen to the outer surface. The second end of the loop wire can extend at least partially through the second attachment slot. The first tube window can be positioned proximal to the first and second attachment slots relative to a distal end of the distal hypotube.

[0035] The length of the first tube window can be between about 0.10 inches and 0.40 inches, and the width of the first tube window can be between about 0.02 inches and 0.10 inches.

[0036] The length of the first tube window can be between about 0.2 inches and 0.30 inches, and the width of the first tube window can be between about 0.035 inches and 0.86 inches.

[0037] The distal hypotube can have a helical cut along the longitudinal axis, and the first tube window can be positioned between adjacent cuts in the helical cut.

[0038] The distal hypotube can include a second tube window. The first tube window and the second tube window can be positioned equidistant from a distal end of the distal hypotube.

[0039] An exemplary method for manufacturing a delivery member for an implantable medical device can include passing a support tube through a lumen of a flexible distal hypotube until a distal end of the support tube is positioned within a length of a tube window of a flexible distal hypotube of the delivery member and is visible through the tube window. The method can include attaching the support tube to the delivery member. The method can include attaching a loop wire to the flexible distal hypotube. The tube window can have a length that is greater than a width, the length being along a longitudinal axis passing through the lumen.

[0040] Attaching the loop wire to the flexible distal hypotube may include threading a first end of the loop wire into a proximal end of a first mounting slot of the flexible distal hypotube. Attaching the loop wire may further include pulling the first end of the loop wire from the proximal end of the first mounting slot in a direction toward a distal end of the first mounting slot having a smaller diameter than the proximal end. Attaching the loop wire may further include attaching the loop wire to the first mounting slot. Attaching the loop wire may further include threading a second end of the loop wire into a proximal end of a second mounting slot of the flexible distal hypotube. Attaching the loop wire may further include pulling the second end of the loop wire from the proximal end of the second mounting slot in a direction toward a distal end of the second mounting slot having a smaller diameter than the proximal end. Attaching the loop wire may further include attaching the loop wire to the second mounting slot.

[0041] The tube window can be positioned proximal to the first and second mounting slots relative to a distal end of the flexible distal hypotube.

[0042] The method can include forming a tube window in the flexible distal hypotube by cutting or etching a tube window between adjacent cuts in the helical cut in the flexible distal hypotube.

[0043] The length of the tube window can be between about 0.10 inches and 0.40 inches, and the width of the tube window can be between about 0.02 inches and 0.10 inches.

[0044] The length of the tube window can be between about 0.2 inches and 0.30 inches, and the width of the tube window can be between about 0.035 inches and 0.86 inches.

[0045] The distal end of the tube window can be positioned approximately 22 mm from the distal end of the flexible distal hypotube. [Brief description of the drawings]

[0046] The above and further aspects of the present invention will be further discussed with reference to the following description in conjunction with the accompanying drawings, in which like numerals indicate like structural elements and features in the various drawings. The drawings are not necessarily to scale, with the focus instead being on illustrating the principles of the invention. The figures depict one or more implementations of the device of the present invention by way of example only, and not by way of limitation. [Figure 1] 1 is a cross-sectional view of a delivery member according to an embodiment of the present invention. [Figure 2A] 2 is a cross-sectional view of a flexible sleeve according to an aspect of the present invention. [Figure 2B] 1 is a cross-sectional view of a stretch resistant tube according to an embodiment of the present invention. [Figure 2C] FIG. 13 is a cross-sectional view of a wire coil attached to a distal hypotube and a proximal hypotube, according to an aspect of the present invention. [Figure 2D] FIG. 13 is a diagram of a distal hypotube having first and second attachment slots according to an embodiment of the present invention. [Figure 2E] FIG. 13 is a diagram of a distal hypotube having first and second attachment slots according to an embodiment of the present invention. [Figure 2F] FIG. 13 is a diagram of a distal hypotube having first and second attachment slots according to an embodiment of the present invention. [Figure 2G] FIG. 13 is a diagram of a distal hypotube having first and second attachment slots according to an embodiment of the present invention. [Figure 2H] FIG. 13 is a diagram of a distal hypotube having first and second attachment slots according to an embodiment of the present invention. [Figure 3A] 1A-1C are diagrams of an engagement system illustrating a sequence for deploying an implant, according to an aspect of the present invention. [Figure 3B] 1A-1C are diagrams of an engagement system illustrating a sequence for deploying an implant, according to an aspect of the present invention. [Figure 3C] 1A-1C are diagrams of an engagement system illustrating a sequence for deploying an implant, according to an aspect of the present invention. [Figure 3D] 1A-1C are diagrams of an engagement system illustrating a sequence for deploying an implant, according to an aspect of the present invention. [Figure 4] 1 is a flow chart illustrating a method for designing and / or constructing a delivery member, according to an embodiment of the present invention. [Diagram 5] 1 is a flowchart illustrating a method for using a delivery system including an exemplary delivery member according to an aspect of the present invention. [Figure 6] 4 is a flow diagram illustrating a method of attaching an implantable medical device to a delivery member, according to an aspect of the present invention. [Figure 7A] 1A is a diagram of a delivery member with a tube window and support tube partially positioned within the inner lumen of a distal hypotube, according to an aspect of the present invention. [Figure 7B] FIG. 13 illustrates a delivery member with a tube window and support tube positioned completely within the inner lumen of the distal hypotube, in accordance with an embodiment of the present invention. [Figure 7C] FIG. 13 is a diagram of a delivery member providing a detailed view of a tube window, according to an embodiment of the present invention. [Figure 7D] 1 is a diagram of an engagement system having a tube window, according to an aspect of the present invention. [Figure 8] 4 is a flow diagram illustrating a method of manufacturing a delivery member for an implantable medical device, according to an aspect of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0047] During an intravascular procedure, such as an aneurysm occlusion treatment, a lack of flexibility in the distal portion of the delivery member of the treatment device may cause the delivery member to retract or otherwise move out of position from the treatment site while an implant or other medical treatment device is being placed at the aneurysm or other treatment site. Thus, a delivery member and engagement system having a more flexible distal portion may provide a stable system for delivering medical devices to neurovascular anatomy, in addition to other applications that face similar challenges. However, flexible structures may tend to deform, stretch, or expand when navigating tortuous anatomy. Deformation of the delivery member may inhibit the ability of the delivery member to navigate to the treatment site and / or effectively deploy the medical device. Stretching of the delivery member may result in premature deployment of the medical device.

[0048] It is an object of the present invention to provide a delivery member having a highly flexible distal portion that is stretch resistant and structurally stable throughout the delivery and deployment of a medical therapeutic device. For ease of explanation, the medical therapeutic device will be generally referred to herein as an "implant", however, as will be recognized and understood by those skilled in the art, aspects of the present invention may be applied to the delivery and deployment of non-implanted medical therapeutic devices.

[0049] According to the present invention, in some examples, the highly flexible distal portion of the delivery member may include a coiled wire, an outer sleeve, and an inner stretch-resistant support tube. The coiled wire may be formed of a substantially linear wire wound into a coil shape and / or a hypotube laser cut in a helical pattern. If the coiled wire is formed from a laser cut hypotube, the helix may be free of interfering cuts connecting the windings within the coil to provide a more flexible coil. The outer sleeve may prevent the coiled wire from deforming radially and / or may provide a smooth surface against which the vessel wall may slide during delivery of the implant. The stretch-resistant support tube may prevent the coiled wire from stretching during delivery of the implant. Thus, the combination of the coiled wire, the outer sleeve, and the stretch-resistant support tube may provide a distal portion of the delivery member with greater flexibility and greater stability than at least some known delivery members.

[0050] Referring to the drawings, as shown in FIG. 1, an exemplary delivery member 10 can include a proximal tube 100, a coil section 200, a distal tube 300, a sleeve 500 surrounding the coil section, and a stretch-resistant support tube 600 within the lumen of the coil section 200. In this disclosure, the terms proximal tube and proximal hypotube can be used interchangeably. Similarly, the terms distal tube and distal hypotube can be used interchangeably. The proximal tube 100 can extend the majority of the length of the delivery member 10 with the coil section 200 and the distal tube 300, forming a length sufficient to absorb most of the pushback that may occur during placement of the implant at the treatment site. In some examples, the length can be about 30 cm to about 50 cm, or more specifically about 40 cm. The proximal tube 100 can have a distal end 104 connected to a proximal end 202 of the coil section 200, which can have a distal end 204 connected to a proximal end 302 of the distal tube 300. As described in more detail herein, the distal tube 300 can include a compressible portion 306. The compressible portion 306 can be formed from a helical break 307 in the distal tube 300, a wound wire, a helical ribbon, or other configuration that allows for axial adjustment in accordance with the present invention. A loop wire 400 can be disposed within the lumen 308 of the distal tube 300 that can secure an implant or other medical procedure device to the delivery member 10. The compressible portion 306 of the distal tube 300 can have attachment slots (e.g., first attachment slot 310 and second attachment slot 316) that allow the loop wire 400 to be threaded through the distal tube 300 from the lumen 308 to the outer surface 309 of the distal hypotube 300.

[0051] Figure 2A is a cross-sectional view of sleeve 500. Figure 2B is a cross-sectional view of stretch-resistant support tube 600. Figure 2C is a cross-sectional view of assembled proximal tube 100, coil section 200 and distal tube 300.

[0052] The coil section 200 may be formed separately from the proximal hypotube 100 and / or the distal hypotube 300. The separately formed coil section 200 may be attached with welds 712, 714, or other suitable attachments to the proximal tube 100 and / or the distal tube 300. Additionally or alternatively, at least a portion of the coil section may be formed from a helical laser cut section of hypotube. The separately formed coil section 200 may be made more flexible as compared to a helical cut tube by selecting a wire having a particular cross section (e.g., circular) with a particular diameter D, or by selecting a wire with material properties that increase flexibility. Conversely, the laser cut section may be more easily fabricated by cutting a single hypotube to form the proximal tube 100, coil section 200, and distal hypotube 300, reducing or eliminating the welds 712, 714, or other attachments. In either case, the wire of coil 200 can have a diameter D measured within a range inclusive of about 0.8 mils and 5 mils (about 20 nm to about 130 nm).

[0053] The coil sections may be formed primarily from a non-radiopaque material such as steel and may include a radiopaque section 216 made from a radiopaque material such as platinum and / or tungsten. The radiopaque section 216 may be positioned between the proximal non-radiopaque section of the coil 212 and the distal non-radiopaque section of the coil 214. The radiopaque section 216 may be positioned a predetermined distance from the distal end 304 of the delivery member 10 to allow a physician to easily visualize the placement of the distal portion of the delivery member during a treatment procedure. The proximal section 212, the radiopaque section 216, and the distal section 214 may be concentrically welded.

[0054] The coil section 200 may be surrounded by a flexible or fused sleeve 500, collectively referred to herein as a "sleeve." The sleeve 500 may prevent the coil 200 from radially expanding and / or engaging the vessel wall during navigation. The sleeve 500 may include a polymer. The polymer may include additives to increase the lubricity of the sleeve 500, allowing the sleeve to slide easily through the vessels of the body. As shown in FIG. 2A, the sleeve 500 may have a wall thickness T measured within a range such as about 0.5 mils and about 2 mils (about 0.01 mm to about 0.05 mm). The sleeve 500 may be further coated with a hydrophilic coating to further minimize friction during intravascular navigation. The sleeve 500 may be fused or bonded to the coil 200, the proximal hypotube 100, and / or the distal hypotube 300.

[0055] The stretch-resistant support tube 600 can be positioned to prevent the coil 200 from stretching during intravascular navigation. The stretch-resistant support tube 600 can include a tube sized to fit inside the lumen 208 of the coil 200. The stretch-resistant tube 600 can also be sized to extend through the entire length of the coil 200 and can be sized to extend into the lumen 308 of the distal tube 300 as well as the lumen 108 of the proximal tube 100. The stretch-resistant support tube 600 can be attached to the proximal tube 100 and the distal tube 300 with adhesive joints 702, 704 or other suitable attachments. The stretch-resistant support tube 600 can remain unattached to the coil sections 200 such that the stretch-resistant support tube 600 and the coil sections 200 can move to some degree independent of one another.

[0056] The delivery member 10 may include a mechanical engagement system for engaging the medical device 12 during delivery to the treatment site, and the delivery member 10 may be mechanically actuated to deploy the medical device 12. A mechanically actuated engagement system may include one or more inner elongate members or pull wires extending through the delivery member that may be manipulated at a proximal end by a physician to deploy the medical treatment device. Such wires or inner elongate members are collectively referred to herein as "pull wires." When referring to an engagement system herein, the engagement system may include a combination of a loop wire 400 and a pull wire 140.

[0057] 2D-2H show an exemplary distal hypotube 300 that can be used to secure a loop wire 400. The loop wire 400 can be positioned to secure an implant or other medical treatment device to a delivery member 10 and can be moved to release the medical device 12 from the implant or other medical treatment device. This conventional approach is described in more detail below with reference to FIGS. 3A-3D. In summary, the loop wire 400 can be extended over the locking portion 18 of the medical device 12. The pull wire 140 can then be slid through an opening 405 in the distal end 404 of the loop wire 400. This can hold the medical device 12 in place until the pull wire 140 can be retracted to release the medical device 12.

[0058] 2D is a side view of the distal hypotube 300 having a first attachment slot 310 and a second attachment slot 316 (the second attachment slot 316 is behind the view). The attachment slots 310, 316 may be openings in the outer surface 309 of the distal hypotube 300 that extend from the lumen 308 to the outer surface 309. The attachment slots 310, 316 may facilitate attachment of the loop wire 400 to the distal hypotube 300. The attachment slots 310, 316 may be laser cut, for example, into the outer surface 309 of the distal hypotube 300.

[0059] The first attachment slot 310 can have a distal end 312 and a proximal end 314. As can be seen, the diameter 313 at the distal end 312 of the first attachment slot 310 can be smaller than the diameter 315 at the proximal end 314. This tapered (or teardrop) design can facilitate attachment of the loop wire 400 to the distal hypotube 300. For example, the loop wire 400 can be routed more easily if the diameter of the proximal end 314 is larger. Once the loop wire 400 is threaded through the larger proximal diameter 315, it can be pulled towards the distal end (312) of the first attachment slot (310). In some embodiments, the transition between the proximal end 314 and the distal end 312 can be slightly tapered, which allows the loop wire 400 to be wedged within the first attachment slot as it is pulled towards the distal end 312. The second mounting slot 316 can be similar in all respects to the first mounting slot 310. For example, the second mounting slot 316 can have a distal end 322 and a proximal end 324, and the diameter 323 of the distal end 322 can be smaller than the diameter 325 of the proximal end 324 of the second mounting slot 316.

[0060] The loop wire 400 can be routed through the attachment slots 310, 316 and attached to the distal hypotube 300 by attachments 408, 409 as it is pulled toward the distal end 312, 322. FIG. 2E shows an exemplary first attachment 408 (the second attachment 409 is behind this view). Using the first attachment slot 310 as an example (the second attachment slot 316 can be similar), the loop wire 400 can be pulled toward the distal end 312 and positioned within the first attachment slot 310 at a desired location within the length of the first attachment slot 310. The loop wire 400 can then be attached to the first attachment slot 310 with the first attachment 408. The first attachment 408 and / or the second attachment 409 can be positioned at the distal end of their corresponding attachment slots 310, 316. However, the first attachment 408 and / or the second attachment 409 do not have to be located at the distal most end of the slot, but rather the first attachment 408 and / or the second attachment 409 can be located in an intermediate portion (i.e., more proximal) of the slot, as shown in FIG. 2E.

[0061] The first attachment 408 can be a weld that holds the loop wire 400 in the first attachment slot 310. In some examples, the loop wire 400 can include a metallic material such as stainless steel, cobalt chrome alloy, titanium, nickel titanium alloy (nitinol), etc. Similarly, the distal hypotube can include a metallic material such as stainless steel, cobalt chrome alloy, titanium, nitinol, etc. This allows the first attachment 408 to be a metallic weld that attaches the loop wire 400 to the first attachment slot 310. In some examples, the loop wire 400 can include a polymeric material such as nylon, polypropylene, silk, polyester, etc. The loop wire can include braided or monofilament wire. The first attachment 408 can also be a thermoplastic weld of the first attachment slot 310.

[0062] Additionally or alternatively, the first attachment 408 may be an epoxy that holds the end of the loop wire 400 to the first mounting slot 408. As described above, the second mounting slot 316 may include a second attachment 409 for attaching the loop wire 400 to the second mounting slot 316. The second attachment 409 may be similar to the first attachment 408.

[0063] In some examples, the first attachment 408 can be a knot on the loop wire 400. As discussed above, the first attachment slot 310 can have a proximal end 314 with a larger diameter than the distal end 312. The loop wire 400 can be pulled through the first attachment slot 310, tied into a knot, and then pulled toward the distal end 312. The knot can be larger than the distal diameter 313 such that the loop wire 400 cannot be pulled back through the first attachment slot 310 after the loop wire 400 is tied into the knot. In other examples, the loop wire 400 can first be tied into a knot and then the knot can be fed through the proximal end 314 of the first attachment slot 310, and then the loop wire 400 can be pulled toward the distal end 312. In these examples, the diameter of the knot can be approximately equal to the first diameter 315 of the first attachment slot 310. This allows the loop wire 400 to be routed through the proximal end 314, but prevents the loop wire 400 from being pulled through the distal end 312 of the first attachment slot 310. The second attachment 409 may similarly be a knot on the opposite end of the loop wire 400.

[0064] 2F is a side view of an exemplary distal hypotube 300. The first attachment slot 310 is at the front of this view and the second attachment slot 316 is at the back. As discussed above, the distal hypotube 300 can have a flexible and / or compressible portion 306. The compressible portion 306 can be formed from a helical cut 307 in the distal hypotube 300, a wound wire, a helical ribbon, or other configuration that allows for axial adjustment in accordance with the present invention. In some examples, the placement of the first attachment slot 310 and / or the second attachment slot 316 can be selected based on the pitch of the helical cut 307. To increase the flexibility of the distal hypotube 300, the first attachment slot 310 can be offset from the second attachment slot 316 by the ratio of the pitch of the helical cut 307, as shown, for example, by the slot offset 320. As shown in the figures, in this example slot offset 320, the first mounting slot 310 can be located opposite the second mounting slot 316 and the first mounting slot 310 can be offset proximally of the second mounting slot 316 by a distance approximately equal to half the pitch 318 of the helical cut 307. However, the first mounting slot 310 does not have to be located opposite the second mounting slot 316. The first mounting slot 310 can be located at a first location equidistant from two adjacent cuts in the helical cut 307 and the second mounting slot 316 can be located at a second location equidistant from two adjacent cuts in the helical cut 307. This is true for any location on the distal hypotube 300, regardless of whether the mounting slots 310, 316 are opposite each other on the outer surface 309.

[0065] 2G is a perspective view of the distal hypotube 300 illustrating an exemplary offset between the first and second mounting slots 310, 316. Offsetting the first and second mounting slots 310, 316 relative to the pitch of the helical cut 307 can increase flexibility of the distal hypotube 300 by not hindering bending of the hypotube about the helical cut 307.

[0066] 2H is a side cross-sectional view of an exemplary distal hypotube 300. In some examples, the first and second attachment slots 310, 316 can be formed in the distal hypotube 300 (e.g., by laser cutting, drilling, etc.) perpendicular to a longitudinal plane 326b through the lumen 308 of the distal hypotube 300. The longitudinal plane 326b is a three-dimensional view of the longitudinal axis 326b through the lumen 308. The perpendicular cuts help facilitate attachment of the loop wire 400 to the first and second attachment slots 310, 316. For example, as the loop wire 400 is routed through the first and second attachment slots 310, 316, the perpendicular cuts can help ensure uniform surface contact between the loop wire 400 and the outer walls of the attachment slots 310, 316.

[0067] 2H also clearly illustrates an example slot offset 320 between the first and second mounting slots 310, 316. As discussed above, the first mounting slot 310 can be located on the distal hypotube 300 opposite the second mounting slot 316 along a diameter line passing through the longitudinal axis 326a. The first and second mounting slots 310, 316 can be offset based on the pitch of the helical cut 307.

[0068] 3A-3D show a delivery member 10 including a mechanical engagement system including a pull wire 140 and a loop wire 400 that can be positioned to secure an implant or other medical treatment device to the delivery member 10 and can be moved to release the medical treatment device from the delivery member 10. The loop wire 400 can be secured to the distal tube 300 using a first attachment 408 and a second attachment 409. The stretch-resistant support tube 600 can be sized to allow the pull wire 140 to pass through the lumens 108, 208, 308 of the proximal tube 100, the coil section 200, and the distal tube 300. For example, the stretch-resistant member 600 can be tubular and have a lumen therethrough, and the pull wire 140 can extend through the lumen of the tubular stretch-resistant support tube 600. During manufacture of the stretch-resistant support tube 600, the stretch-resistant support tube 600 can be extruded over the pull wire 140.

[0069] The combination of the coil 200, sleeve 500, and stretch-resistant support tube 600 can provide a highly flexible distal portion of the delivery member 10 suitable for navigating tortuous anatomy, including neurovascular structures. The stretch-resistant support tube 600 can support the coil 200 and prevent it from extending significantly during vascular navigation, thereby reducing tension on the pullwire 140 extending therethrough and reducing the likelihood of premature deployment of an attached medical procedure device.

[0070] The proximal tube 100 may include a flexible section 106 from which material has been removed to increase the flexibility of the flexible section 106. The flexible section 106 may be cut in a helical pattern. The helical pattern of the flexible section 106 may lack interfering cuts connecting the windings within the helix. The stretch-resistant support tube 600 may extend through the flexible section 106 and be attached to the proximal tube 100 in a proximal direction from the flexible section 106. In this way, the stretch-resistant support tube 600 may prevent the proximal tube 100 and the flexible section 106 of the coil section 200 from stretching. The sleeve 500 may cover at least a portion of the flexible section 106 to prevent deformation of the flexible section during intravascular navigation and / or reduce friction with the vascular structures and the flexible section 106. In some examples, the sleeve 500 can cover approximately 10 cm of the proximal tube 100 approaching and / or including the distal end 104 of the proximal tube 100 .

[0071] The distal hypotube 300 can have a compressible portion 306. The compressible portion 306 can be axially adjustable between an elongated state and a compressed state. The distal hypotube 300 can also be flexible such that the distal hypotube 300 provides a stable system for delivery of a medical device within the neurovascular anatomy. The distal hypotube 300 can have a helical cut 307 formed, for example, by a laser cutting operation to create a compressible and / or flexible structure. Additionally or alternatively, the compressible portion 306 can be formed of a wire wound, a helical ribbon, or other configuration that allows for axial adjustment in accordance with the present invention. Preferably, the compressible portion 306 is in an elongated state at rest and will automatically or elastically return from the compressed state to the elongated state unless otherwise restrained.

[0072] 3A-3D illustrate the removal of a medical device 12 using a mechanical engagement / deployment system. FIG. 3A shows the engagement system 140, 400 engaged to the locking portion 18 of the medical device 12. The compressible portion 306 of the distal tube 300 can be compressed and the opening 405 of the loop wire 400 at the distal end 404 of the loop wire 400 can be positioned through the locking portion 18. Once the pull wire 140 is threaded through the opening 405, the medical device 12 is secured. FIG. 3B shows the pull wire 140 being pulled proximally to initiate the release sequence of the medical device 12. FIG. 3C illustrates the moment the pull wire 140 exits the opening 405 and is unwound from the loop wire 400. The distal end 404 of the loop wire 400 moves away and out of the locking portion 18. As can be seen, at this point there is nothing holding the medical device 12 to the delivery member 10 (e.g., the distal hypotube 300). Figure 3D shows the end of the release sequence. The compressible portion 306 now expands / returns to its original shape and "springs" forward. An elastic force E is applied by the distal end 304 of the distal tube 300 to the medical device 12, "pushing" it out and ensuring complete detachment and delivery of the medical device 12.

[0073] The above description of the drawings shows a generally hollow or tubular structure 100, 200, 300, 500, 600 according to the present invention. As used herein, the terms "tubular" and "pipe / tube" are to be interpreted broadly and are not limited to structures with a right cylindrical or strictly circular cross section, or structures with a uniform cross section along their entire length. For example, a tubular structure or tubular system is generally illustrated as a substantially right cylindrical structure. However, a tubular system may have a tapered or curved outer surface without departing from the scope of the present invention.

[0074] FIG. 4 is a flow chart including method steps for constructing or designing a delivery member, such as the exemplary delivery members described herein. Referring to the method 800 outlined in FIG. 4, in step 810, a first hypotube, a second hypotube, a flexible sleeve, a wire coil, and a stretch-resistant support tube can be selected. The first hypotube can be a proximal hypotube 100 as described herein or as otherwise known to one of ordinary skill in the art. The second hypotube can be a distal hypotube 300 as described herein or as otherwise known to one of ordinary skill in the art. The flexible sleeve can be a sleeve or fused jacket 500 as described herein or as otherwise known to one of ordinary skill in the art. The wire coil can include a support coil, a coil section 200 as described herein, or as otherwise known to one of ordinary skill in the art. The stretch-resistant member can be a stretch-resistant support tube 600 as described herein or as otherwise known to one of ordinary skill in the art.

[0075] In step 820, a stretch resistant member can be positioned in the lumen of the wire coil. In step 820, the positioned stretch resistant member can be substantially tubular. In step 830, the first hypotube, the wire coil, and the second hypotube can be attached to one another. In step 840, the stretch resistant member is attached to the first hypotube and the second hypotube. The first hypotube, the wire coil, and the second hypotube can be attached as shown and described herein or by other means as would be understood by one of ordinary skill in the art. Steps 820, 830, and 840 do not have to be performed in that order and can be performed simultaneously. For example, a stretch-resistant member may be attached to one of the first and second hypotubes as shown in step 840, then the hypotube to which the stretch-resistant member is attached can be attached to the wire coil as shown in step 830, then the stretch-resistant member can be positioned through the wire coil as shown in step 820, then the other of the hypotubes can be attached to the wire coil as shown in step 830, and then the stretch-resistant member can be attached to the other hypotube as shown in step 840.

[0076] At step 850, the wire coil may be covered with a flexible sleeve. The flexible sleeve may cover some or all of the outer surface of the wire coil. Step 850 may also include fusing the flexible sleeve to the wire coil and / or otherwise attaching the flexible sleeve to the delivery member. If the second hypotube has a flexible section, at step 850, the flexible sleeve may also be positioned to cover at least a portion of the flexible section.

[0077] At step 860, the implant can be removably attached to the distal end of the first hypotube. At step 860, the implant can be attached by positioning a loop wire within the first hypotube and a pull wire can be extended through the first hypotube, the coil wire, and the second hypotube and positioned by securing the implant with the loop wire and the pull wire. The pull wire can extend from a proximal end of the second hypotube. If the first hypotube has a compressible portion, at step 860, the compressible portion can be compressed and the implant can be attached to the delivery member while the compressible portion is compressed.

[0078] 5 is a flow chart including method steps for administering an intravascular treatment using a system including a delivery member, such as the examples of delivery members described herein. Referring to method 900 outlined in FIG. 5, in step 910, a system can be selected having a distal hypotube, a proximal hypotube, a coil section coaxially positioned between the hypotubes, a flexible sleeve covering the coil section, a stretch resistant member positioned within the coil section, and a medical treatment device attached to or near the distal hypotube. The system can be suitable for intravascular treatment as described and illustrated herein or as otherwise known to one of skill in the art.

[0079] At step 920, the system can be moved through a catheter to a treatment site, such as the site of an aneurysm or other abnormality in a blood vessel. At step 930, the system can be bent as it is moved through the catheter. At step 940, the coil section of the system can be prevented from deforming by a flexible sleeve and a stretch resistant member, where the flexible sleeve can prevent the coil section coil from deforming radially while the stretch resistant member can prevent the coil from extending longitudinally.

[0080] At step 950, the medical therapeutic device may be deployed. If the medical therapeutic device is an implant, at step 950, the implant may be removed. At step 960, the distal tube may be extended to push the medical therapeutic device out of the distal tube. If the medical therapeutic device is an implant that was removed at step 950, at step 960, the detached implant may be expelled from the distal tube in response to expansion of the distal tube.

[0081] FIG. 6 is a flow diagram including method steps for attaching an implantable medical device to a delivery member. Referring to method 1000 outlined in FIG. 6, in step 1010, a delivery member can be provided. The delivery member can include a flexible distal hypotube as described herein. In step 1020, a first end of a loop wire can be threaded through a proximal end of a first attachment slot of the distal hypotube. In step 1030, the first end of the loop wire can be pulled from the proximal end of the first attachment slot in a direction toward the distal end. As noted above, the distal end of the first attachment slot can have a smaller diameter than the proximal end.

[0082] At step 1040, the loop wire can be attached to the first mounting slot. This attachment can be done in a variety of ways as described herein above. The loop wire can be welded to the first mounting slot. In another example, the loop wire can be secured to the first mounting slot via epoxy. In another example, the loop wire can have a knot tied to a first end of the loop wire. The knot can be tied before pulling the first end of the loop wire through the proximal end of the first mounting slot. In this case, the knot can be approximately the same size as the diameter of the proximal end of the first mounting slot. This allows the knot to be fed through the proximal end but prevents the knot from being pulled back through the distal end. The knot can also be tied after the first end of the loop wire is pulled through the proximal end of the first mounting slot. The knot can be larger than one or both of the proximal and distal ends of the first mounting slot such that the loop wire cannot be pulled back through the first mounting slot. The first end of the loop wire can be attached to the distal end of the first mounting slot, or the first end of the loop wire can be attached to any other position within the first mounting slot that is narrower than the proximal end (see, for example, FIG. 2E).

[0083] In steps 1050-1070, the method steps outlined above in steps 1020-1040 can be repeated for the second mounting slot. For example, the second end of the loop wire can be placed in the second mounting slot similar to the process described above with respect to the first end of the loop wire and the first mounting slot.

[0084] 7A-7D show a delivery member 10 including one or more tube windows 720 positioned in the distal hypotube 300. In some embodiments, the delivery member 10 can include a support tube (e.g., a stretch resistant support tube 600) to provide support for the attachment of the coil section 200 and the distal tube 300. With brief reference to FIG. 2C, the distal end 204 of the coil section 200 abuts the proximal end 302 of the distal tube 300. To support this junction, the delivery member 10 can include a support tube 600 that crosses this junction and is at least partially within the lumen 308 of the distal tube 300. The support tube 600 can be attached to the delivery member 10, for example, via an adhesive, to provide support to the junction between the coil section 200 and the distal tube 300. In some embodiments, a sleeve 500 as described herein (see, e.g., FIG. 1 ) can be positioned around the outer surface 309 of the distal hypotube 300, and the sleeve 500 can be melted along the distal tube 300 and coil section 200 over the area where the support tube 600 is attached. The combination of an attached support tube 600 (e.g., via an adhesive such as glue) and a melted sleeve 500 (which can penetrate the coils of the coil section 200 and adhere to the support tube 600) can help hold the components together. The support tube 600 can be manufactured from a polymeric material such as polyetheretherketone (PEEK) and other polymers.

[0085] Positioning of the support tube 600 can be important as improper positioning can lead to manufacturing difficulties. For example, if the support tube 600 is positioned too proximally, proper support at the junction between the distal tube 300 and the coil section 200 may not be achieved. If the support tube 600 is positioned too distally, the support tube 600 may interfere with positioning of the attachments (e.g., attachments 408, 409) in the attachment slots (e.g., first attachment slot 310 and second attachment slot 316). The present disclosure provides a solution to aid in positioning of the support tube 600 by using one or more tube windows 720, as shown in Figures 7A-7D.

[0086] 7A, the delivery member 10 can include a first tube window 720. The first tube window 720 can extend from the lumen 308 of the distal hypotube 300 to the outer surface 309 of the distal hypotube 300. Thus, the first tube window 720 can form an opening through which the support tube 600 can be visualized. The first tube window 720 can have a length (L) that is greater than the width (W), the length (L) being along a longitudinal axis 326b that passes through the lumen 308 of the distal hypotube 300. The longitudinal axis 326b is shown in detail in FIG. 2H.

[0087] In some examples, the delivery member 10 can include a second tube window 722, which can be similar to the first tube window 720, so that the position of the support tube 600 within the lumen 308 can be viewed at different angles. In examples having two tube windows, the first tube window 720 and the second tube window 722 can be positioned equidistant from the distal end 304 of the distal hypotube 300. Throughout this disclosure, when referring to a single "tube window," it can be referred to as the "tube window 720." However, it will be understood that any description of the tube window 720 can be equally applied to the first tube window or the second tube window 722. The tube window 720 can be formed in the distal hypotube 300 by cutting or etching the tube window 720 into the distal hypotube 300. In some examples, the tube window 720 can be cut or etched between adjacent cuts in the helical cut 307 in the distal hypotube 300.

[0088] FIG. 7A is a diagram of a delivery member 10 with the support tube 600 and tube window 720 positioned partially within the inner lumen 308 of the distal hypotube 300. In other words, the support tube 600 has not been inserted to its final position in FIG. 7A. FIG. 7B is a diagram of a delivery member with the tube window and support tube 600 positioned completely within the inner lumen 308 of the distal hypotube 300, according to an embodiment of the present invention. The tube window 720 can be positioned a distance 726 from the distal end 304 of the distal hypotube 300 to ensure that the support tube 600 is properly positioned. To illustrate, when manufacturing the delivery member 10 by inserting the support tube 600 into the device, if the distal end 752 of the support tube 600 is visible within the length (L) of the tube window 720, it can be determined that the support tube 600 is inserted in the correct position. If none of the support tube 600 is visible within the tube window 720, the support tube 600 is not inserted deep enough. If the support tube 600 is visible in the tube window 720, but the distal end 752 of the support tube 600 is not visible, the support tube 600 is inserted too far.

[0089] FIG. 7C is a side view of a delivery member 10 according to an embodiment of the present invention, the side view providing a detailed view of the tube window 720. This view shows the support tube 600 in its final position as the distal end 752 of the support tube 600 is visible within the length (L) of the tube window 720. The exemplary delivery member 10 shown in FIG. 7C includes a second tube window 722 as indicated by being directly visible through the first and second windows. The length (L) of the tube window 720 can be from about 0.10 inches to about 0.40 inches, for example, the length (L) of the tube window 720 can be from about 0.2 inches to about 0.30 inches. The width (W) of the tube window 720 can be from about 0.02 inches to about 0.10 inches, for example, the width (W) of the tube window 720 can be from about 0.035 inches to about 0.86 inches. These dimensions can provide visibility of the support tube 600 within the window(s), while also maintaining the structural integrity of the distal tube 300 and the spiral break 307.

[0090] FIG. 7D is a diagram of an engagement system having a tube window 720, according to an embodiment of the invention. The diagram of FIG. 7D is similar to that of FIG. 3A, except that the delivery member 10 of FIG. 7D includes a tube window 720 in addition to the mounting slots 310, 316 described herein. It will be understood that any of the features described above with reference to FIGS. 1-6 may be applied to a delivery member 10 including one or more tube windows 720. Referring again to FIG. 7D, the first tube window 720 (and second tube window 722, if present) may be positioned proximal to the distal end 304 of the distal tube 300 in a location that does not interfere with the attachments 408, 409 at the mounting slots 310, 316. For example, the distal end 724 of the tube window 710 can be positioned a distance 726 between about 15 mm and about 25 mm from the distal end 304 of the distal hypotube 300, for example, about 22 mm from the distal end 304 of the distal hypotube 300.

[0091] 8 is a flow diagram illustrating a method 1100 of manufacturing a delivery member 10 for an implantable medical device 12 according to an embodiment of the present invention. The method 1100 may begin at block 1105, which may include forming tube opening tube windows (e.g., first tube window 720 and / or second tube window 722) in the distal hypotube 300 by cutting or etching tube windows 720 between adjacent cuts in the spiral cut 307.

[0092] At block 1110, the method 1100 may include passing a support tube 600 through the lumen 308 of the flexible distal hypotube 300 of the delivery member 10. The support tube 600 may be advanced until a distal end 752 of the support tube 600 is positioned within and visible through the length (L) of the tube window 720 of the flexible distal hypotube 300.

[0093] At block 1115, the method 1100 may include attaching the support tube 600 to the delivery member 10. As discussed above, the support tube 600 may be attached to the delivery member 10 via, for example, an adhesive disposed between the support tube 600 and (i) the distal hypotube 300 and (ii) the coil section 200 of the delivery member 10. At block 1120, the method 110 may include attaching the loop wire 400 to the flexible distal hypotube 300. In some examples, the method of attaching the loop wire may be performed according to steps 1020-1070 described above with reference to FIG. 6 and method 1000.

[0094] As used herein, the term "about" or "approximately" in relation to any numerical value or numerical range indicates a suitable dimensional tolerance that enables a portion of a component or a collection of components to function for its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of values ​​of ±20% of the recited value, for example, "about 90%" may refer to a range of values ​​of 71% to 99%.

[0095] The descriptions contained herein are examples of embodiments of the invention and are not intended to limit the scope of the invention in any way. As described herein, the invention contemplates many variations and modifications of the delivery system, delivery members, and engagement systems, including alternative component configurations, alternative materials, alternative medical treatment devices, alternative means for deploying the medical treatment devices, alternative geometric shapes of the individual components, alternative means for attaching the components, etc. These modifications will be apparent to those skilled in the art to which the invention pertains and are intended to be within the scope of the following claims.

[0096] [Embodiment] (1) A delivery device comprising: A distal hypotube, a distal end shaped to receive an implantable medical device; a longitudinal axis of the distal hypotube from the distal end to the proximal end; a distal hypotube comprising: a first tube window extending from a lumen of the distal hypotube to an outer surface of the distal hypotube, the first tube window having a length greater than a width, the length being along the longitudinal axis; a support tube positioned within the lumen of the distal hypotube; A delivery member comprising: (2) A delivery member as described in embodiment 1, wherein the distal end of the support tube is disposed within the length of the first tube window and positioned so as to be visible outside the distal hypotube. (3) a loop wire extending through an opening in the implantable medical device; and The delivery member of embodiment 1, further comprising a pull wire extending through the lumen, the pull wire engaged with the loop wire and movable to retract proximally to disengage the loop wire to deploy the implantable medical device. (4) the distal hypotube further comprises a first attachment slot extending from the lumen of the distal hypotube to the outer surface of the distal hypotube; 2. The delivery member of embodiment 1, wherein a first end of the loop wire extends at least partially through the first mounting slot. (5) the distal hypotube further comprises a second attachment slot extending from the lumen to the exterior surface; a second end of the loop wire extending at least partially through the second mounting slot; 5. The delivery member of embodiment 4, wherein the first tube window is positioned proximal to the first mounting slot and the second mounting slot relative to the distal end of the distal hypotube.

[0097] (6) The delivery device of claim 1, wherein the length of the first tube window is about 0.10 inches to 0.40 inches and the width of the first tube window is about 0.02 inches to 0.10 inches. (7) The delivery device of claim 1, wherein the length of the first tube window is about 0.2 inches to 0.30 inches and the width of the first tube window is about 0.035 inches to 0.86 inches. (8) The delivery member of embodiment 1, wherein the distal hypotube further comprises a helical cut along the longitudinal axis, and the first tube window is positioned between adjacent cuts in the helical cut. (9) The delivery member of embodiment 1, wherein the distal hypotube further comprises a second tube window, and the first tube window and the second tube window are positioned equidistant from the distal end of the distal hypotube. (10) The delivery member of embodiment 1, wherein the distal end of the first tube window is positioned approximately 22 mm from the distal end of the distal hypotube.

[0098] (11) A method of manufacturing a delivery member for an implantable medical device, the method comprising: passing a support tube through a lumen of a flexible distal hypotube of the delivery member until a distal end of the support tube is positioned within a length of a tube window of the flexible distal hypotube and is visible through the tube window; Attaching the support tube to the delivery member; and attaching a loop wire to the flexible distal hypotube; The method, wherein the tube window has a length greater than a width, the length of the tube window being along a longitudinal axis passing through the lumen. (12) Attaching the loop wire to the flexible distal hypotube comprises: threading a first end of the loop wire through a proximal end of a first mounting slot of the flexible distal hypotube; pulling the first end of the loop wire from the proximal end of the first mounting slot toward a distal end of the first mounting slot, the distal end having a smaller diameter than the proximal end; Attaching the loop wire to the first attachment slot; threading a second end of the loop wire through a proximal end of a second mounting slot of the flexible distal hypotube; pulling the second end of the loop wire from the proximal end of the second mounting slot toward a distal end of the second mounting slot having a smaller diameter than the proximal end; Attaching the loop wire to the second attachment slot. (13) The method of embodiment 12, wherein the tube window is positioned proximal to the first and second mounting slots relative to the distal end of the flexible distal hypotube. (14) The method of claim 11, further comprising forming the tube window in the flexible distal hypotube by cutting or etching the tube window between adjacent cuts in the helical cut in the flexible distal hypotube. 15. The method of claim 11, wherein the length of the tube window is about 0.10 inches to 0.40 inches and the width of the tube window is about 0.02 inches to 0.10 inches.

[0099] 16. The method of claim 11, wherein the length of the tube window is about 0.2 inches to 0.30 inches and the width of the tube window is about 0.035 inches to 0.86 inches. (17) The method of embodiment 11, wherein the distal end of the tube window is positioned approximately 22 mm from the distal end of the flexible distal hypotube.

Claims

1. A delivery member comprising: A distal hypotube, a distal end shaped to receive an implantable medical device; a longitudinal axis of the distal hypotube from the distal end to the proximal end; a distal hypotube comprising: a first tube window extending from a lumen of the distal hypotube to an outer surface of the distal hypotube, the first tube window having a length greater than a width, the length being along the longitudinal axis; a support tube positioned within the lumen of the distal hypotube; A delivery member comprising:

2. The delivery member of claim 1 , wherein a distal end of the support tube is disposed within the length of the first tube window and positioned so as to be visible exteriorly of the distal hypotube.

3. a loop wire extending through an opening in the implantable medical device; 10. The delivery member of claim 1, further comprising a pull wire extending through the lumen, the pull wire engaged to the loop wire and movable to retract proximally to disengage the loop wire to deploy the implantable medical device.

4. the distal hypotube further comprises a first attachment slot extending from the lumen of the distal hypotube to the outer surface of the distal hypotube; The delivery member of claim 1 , wherein a first end of a loop wire extends at least partially through the first mounting slot.

5. the distal hypotube further comprises a second attachment slot extending from the lumen to the outer surface; a second end of the loop wire extending at least partially through the second mounting slot; The delivery member of claim 4 , wherein the first tube window is positioned proximal to the first and second attachment slots relative to the distal end of the distal hypotube.

6. 10. The delivery member of claim 1, wherein the length of the first tube window is about 0.10 inches to 0.40 inches and the width of the first tube window is about 0.02 inches to 0.10 inches.

7. 10. The delivery member of claim 1, wherein the length of the first tube window is about 0.2 inches to 0.30 inches and the width of the first tube window is about 0.035 inches to 0.86 inches.

8. 2. The delivery member of claim 1, wherein the distal hypotube further comprises a helical cut along the longitudinal axis, the first tube window being positioned between adjacent cuts in the helical cut.

9. 10. The delivery member of claim 1, wherein the distal hypotube further comprises a second tube window, the first tube window and the second tube window being positioned equidistant from the distal end of the distal hypotube.

10. The delivery member of claim 1 , wherein the distal end of the first tube window is positioned approximately 22 mm from the distal end of the distal hypotube.

11. 1. A method of manufacturing a delivery member for an implantable medical device, the method comprising: passing a support tube through a lumen of a flexible distal hypotube of the delivery member until a distal end of the support tube is positioned within a length of a tube window of the flexible distal hypotube and is visible through the tube window; Attaching the support tube to the delivery member; and attaching a loop wire to the flexible distal hypotube; The method, wherein the tube window has a length greater than a width, the length of the tube window being along a longitudinal axis passing through the lumen.

12. Attaching the loop wire to the flexible distal hypotube includes: threading a first end of the loop wire through a proximal end of a first mounting slot of the flexible distal hypotube; pulling the first end of the loop wire from the proximal end of the first mounting slot toward a distal end of the first mounting slot, the distal end having a smaller diameter than the proximal end; Attaching the loop wire to the first attachment slot; threading a second end of the loop wire through a proximal end of a second mounting slot of the flexible distal hypotube; pulling the second end of the loop wire from the proximal end of the second mounting slot toward a distal end of the second mounting slot having a smaller diameter than the proximal end; and attaching the loop wire to the second attachment slot.

13. The method of claim 12 , wherein the tube window is positioned proximal of the first and second mounting slots relative to the distal end of the flexible distal hypotube.

14. 12. The method of claim 11, further comprising forming the tube window in the flexible distal hypotube by cutting or etching the tube window between adjacent cuts in a helical cut in the flexible distal hypotube.

15. 12. The method of claim 11, wherein the length of the tube window is about 0.10 inches to 0.40 inches and the width of the tube window is about 0.02 inches to 0.10 inches.

16. 12. The method of claim 11, wherein the length of the tube window is about 0.2 inches to 0.30 inches and the width of the tube window is about 0.035 inches to 0.86 inches.

17. 12. The method of claim 11, wherein the distal end of the tube window is positioned approximately 22 mm from the distal end of the flexible distal hypotube.

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