Detachment indicator for implant deployment

Abstract

A delivery system for deploying an implantable medical device to a target location in a blood vessel of a body can include a tubular body having a lumen extending therethrough, a pull wire extending through the lumen, and a proximal support tube disposed within the lumen, the proximal support tube being engaged with the pull wire such that proximal translation of the support tube causes proximal translation of the pull wire. The proximal support tube can include a marked distal segment that is not visible to an operator of the delivery system prior to release of the implant and becomes visible when the proximal support tube is pulled proximally by a distance sufficient to cause the delivery system to release the implant.

Description

Technical Field

[0001] The present invention relates to an aneurysm treatment device, and more particularly to a delivery system for deploying an implantable medical device to a target location in a blood vessel of the body, the delivery system including a detachment indicator indicating when the implantable medical device has been deployed.

Background Art

[0002] Numerous intravascular implant devices are known in the art. Many are mechanically deployed via a system that combines one or more catheters and wires for delivery. Examples of implants that can be mechanically delivered include embolization elements, stents, grafts, drug delivery implants, flow diverters, filters, stimulation leads, sensing leads, or other implantable structures delivered through a microcatheter. Physicians desire feedback that the detachment cycle has been successfully completed. In most mechanical delivery systems, the inner tube is held within the lumen of the delivery system pusher and attached to an internal wire that advances the length of the device. When pulled, the internal wire translates rearward to detach the implant. In conventional systems, the identifier that the detachment cycle has been completed is that the inner tube has been translated and thus its length has increased. However, in conventional deployment systems, it is difficult for a physician to visually determine whether the implant has been successfully deployed because a slight change in length is difficult to visually discern.

Summary of the Invention

Problems to be Solved by the Invention

[0003] Accordingly, there is a need for a deployment system having a detachment indicator that indicates to a physician that the implant has been successfully deployed.

Means for Solving the Problems

[0004] This specification discloses various exemplary systems, devices, and methods of the present disclosure that can address the above needs. By way of example, generally, a delivery system for deploying an implantable medical device to a target location in a blood vessel of the body is provided. The delivery system can include a tubular body having a lumen extending therethrough. The delivery system can include a pull wire extending through the lumen. The delivery system can include a proximal support tube disposed within the lumen. The proximal support tube can include a marked distal segment covered by the tubular body such that the marked distal segment is not visible to an operator of the delivery system. The proximal support tube can be configured to engage the proximal end of the pull wire such that proximal translation of the proximal support tube translates the pull wire proximally, thereby releasing the implantable medical device from the distal end of the tubular body. The proximal support tube can be configured such that proximal translation of the proximal support tube that effects release of the implantable medical device moves the marked distal segment out of the lumen of the tubular body such that the marked distal segment becomes visible.

[0005] The delivery system can further include a loop wire having a loop opening in a distal portion of the loop wire positioned near the distal end of the tubular body. The loop wire and the pull wire are positioned to secure the implantable medical device to the delivery system.

[0006] The implantable medical device can be deployed in response to proximal translation of the proximal support tube, whereby the distal end of the pull wire can exit the loop opening, whereby the loop wire and the pull wire can disengage the medical device from the delivery system.

[0007] The marked distal segment can include a laser etching visible to an operator of the delivery system upon deployment of the implantable medical device.

[0008] The marked distal segment can include an anodized portion of the proximal support tube visible to an operator of the delivery system upon deployment of the implantable medical device.

[0009] The marked distal segment can include a printed or dipped portion of the proximal support tube that is visible to the operator of the delivery system during deployment of the implantable medical device.

[0010] The marked distal segment can be clearly distinguishable from the rest of the proximal support tube.

[0011] The rest of the proximal support tube can include a first color, and the marked distal segment can include a second color distinguishable from the first color.

[0012] The proximal translation of the proximal support tube can be from about 6 millimeters to about 12 millimeters to expose the marked distal portion.

[0013] The proximal translation of the proximal support tube can be from about 6 millimeters to about 12 millimeters to deploy the implantable medical device.

[0014] The tubular body can include a proximal tube, a flexible tube distal to the proximal tube, and a distal tube distal to the flexible tube.

[0015] The flexible tube can include interference cuts.

[0016] The distal tube can further include a compressed distal portion positioned near the implantable medical device. The compressed portion can provide an elastic force to the implantable medical device, thereby facilitating release of the implantable medical device from the delivery system.

[0017] The compressed distal portion can include a helical cut portion of the delivery tube.

[0018] In another aspect, a method for using a delivery system to deploy an implantable medical device to a target location in a blood vessel of a body is disclosed. The method can include providing a tubular body. The tubular body can include a lumen extending therethrough. The method can include extending a pull wire through the lumen. The method can include providing a proximal support tube disposed within the lumen. The proximal support tube can include a marked distal segment covered by the tubular body such that the marked distal segment is not visible to an operator of the delivery system. The method can include engaging a proximal end of the pull wire to the proximal support tube such that proximal translation of the proximal support tube translates the pull wire proximally. The method can include using the pull wire to secure an implantable medical device to the tubular body. The method can include delivering an implantable medical device to a target location in a blood vessel of a body while the marked distal segment remains covered by the tubular body. The method can include translating the proximal support tube proximally to release the implantable medical device from the distal end of the tubular body, thereby translating the marked distal segment proximally out of the lumen such that the marked distal segment becomes visible.

[0019] The marked distal segment can include a laser etching visible to an operator of the delivery system upon deployment of the implantable medical device.

[0020] The marked distal segment can include an anodized portion of the proximal support tube visible to an operator of the delivery system upon deployment of the implantable medical device.

[0021] The marked distal segment can include a printed or dipped portion of the proximal support tube visible to an operator of the delivery system upon deployment of the implantable medical device.

[0022] The remaining portion of the proximal support tube can include a first color, and the marked distal segment can include a second color distinguishable from the first color.

[0023] Proximal translation of the proximal support tube from about 6 millimeters to about 12 millimeters is effective to expose the marked distal portion and deploy the implantable medical device. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The above and further aspects of the present invention will be further considered with reference to the following description in conjunction with the accompanying drawings, in which like numbers in the various drawings indicate like structural elements and features. The drawings are not necessarily to scale, and instead, the focus is on illustrating the principles of the present invention. The figures depict one or more implementations of the device of the present invention as examples, not as limitations.

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[0025] The following description of specific embodiments of the present invention should not be used to limit the scope of the present invention. The drawings are not necessarily to scale, depict selected embodiments, and are not intended to limit the scope of the present invention. The detailed description is illustrative, not limiting, and is presented by way of example to illustrate the principles of the present invention. Other embodiments, features, aspects, embodiments, and advantages of the present invention will become apparent to those skilled in the art from the following description, which is one of the best modes contemplated for carrying out the present invention by way of illustration. As will be recognized, the present invention is capable of other different aspects or equivalent aspects without departing from the present invention. Accordingly, the drawings and description are to be regarded as illustrative in nature and not restrictive.

[0026] Any one or more of the teachings, expressions, variations, embodiments, etc. described herein may be combined with any one or more of the other teachings, expressions, variations, embodiments, etc. described herein. Accordingly, the teachings, expressions, variations, embodiments, etc. described below should not be considered in isolation from each other. In light of the teachings herein, various suitable ways of combining with the teachings herein will be readily apparent to those skilled in the art. Such modifications and variations are intended to be included within the scope of the claims.

[0027] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates a preferred dimensional tolerance that allows a component or collection to function for the intended purpose described herein. More specifically, "about" or "approximately" can refer to a range of values that are ±10% of the recited value. For example, "about 90%" can refer to a range of values from 81% to 99%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and the use of the present invention in human patients represents a preferred embodiment, but is not intended to limit the system or method to human use.

[0028] Referring to FIG. 1, FIG. 1 shows an exemplary delivery system 10 for deploying an implantable medical device 12 to a target location in a blood vessel of the body. The exemplary delivery system 10 can include a proximal tube 100, a flexible tube 550 positioned distally of the proximal tube 100, and a distal tube 570 positioned distally of the flexible tube 550. The proximal tube 100, the flexible tube 550, and the distal tube 570 can collectively have a lumen 608 extending therethrough. That is, the lumen 608 extends from the proximal end of the proximal tube 100, through the flexible tube 550, and through the distal tube 570. Collectively, the proximal tube 100, the flexible tube 550, and the distal tube 570 can be referred to as a tubular body 90. The tubular body can include a proximal end 92 and a distal end 94 as shown in FIG. 1. The implant 12 can be positioned distally of the distal tube 570.

[0029] The flexible tube 550 can each include coiled wire support coils attached to the proximal tube 110 and the distal tube 570 at each end. Alternatively, the flexible tube 550 can include a laser cut hypo tube that includes interference cuts 560 as illustrated in FIG. 1. In this example, it is preferred that the flexible tube 550 is continuous with the proximal tube 100 and the distal tube 570 such that the tubes 100, 550, 570 are formed from a single hypo tube. The interference cuts 560 can provide a high level of flexibility to the flexible tube 550. A sleeve 500 can surround the flexible tube 550 to provide a smooth outer surface for the delivery system 10 on the flexible tube 550.

[0030] The inner support tube 510 can be positioned within the lumen 608 of the flexible tube 550. The inner support tube 510 can be welded or otherwise attached to the inner sidewall of the flexible tube 550. The inner support tube 510 can provide structural rigidity to the flexible tube 550. In some examples, the inner support tube 510 can prevent the flexible tube 550 from elongating. The inner support tube 510 is optional if the interference cuts provide sufficient structural support to the flexible tube 550 without the support tube 510, or if other features are included to provide structural support to the flexible tube 550.

[0031] The pull wire 140 can extend through the lumen 608 of the delivery system 10. The proximal support tube 110 can be positioned within the lumen 608 of the proximal tube 100. The proximal support tube 110 can be welded or otherwise attached to the inner sidewall of the proximal tube 100. Both the proximal support tube 110 and the inner support tube 510 can be considered part of the tubular body 90. The proximal support tube 110 can be considered to be located on the proximal end 92 of the tubular body 90. The pull wire 140 can include a pull wire bead 142 located on the proximal end of the pull wire 140. The pull wire bead 142 can be sized such that the pull wire bead 142 interferes with the proximal support tube 110 and the proximal support tube 110 holds the pull wire bead 142 proximal to the proximal tube 100, i.e., the pull wire bead 142 is larger than the space between the proximal support tubes 110. Alternatively, the proximal end of the pull wire can be welded or otherwise engaged to the proximal tube 110 as would be understood by one of ordinary skill in the art.

[0032] The loop wire opening 405 of the loop wire 400 (also illustrated with respect to FIGS. 8A - 8D) can be located in the distal portion 404 of the loop wire 400 and can extend through the locking member 18 of the implant 12. The distal end 144 of the pull wire 140 can be positioned through the loop wire opening 405 of the loop wire 400 to secure the implant 12 to the delivery system 10. The loop wire proximal ends 406, 408 can be attached to the distal tube 570 as illustrated. Additionally or alternatively, one or both of the loop wire proximal ends 406, 408 can be affixed to the proximal tube 100 to provide structural support to the flexible tube 550. Additionally or alternatively, the loop wire proximal ends 406, 408 can be attached to the pull wire 140. In this example, the loop wire 400 can be made of an elastic material such that proximal translation of the pull wire 140 causes the loop wire 400 to stretch and be placed under tension, thereby providing resistance to further proximal translation of the pull wire 140. The loop wire 400 can be effective in preventing premature detachment of the implant 12 from the delivery system 10.

[0033] The proximal support tube 110 can include a marked distal segment 114 disposed within the proximal tube 100. The marked distal segment 114 can be configured to be hidden from the view of the operator of the delivery system 10 while the implant 12 is being delivered to the target location within the patient. When the pull wire 140 is pulled proximally a sufficient distance to disengage the implant 12, the proximal support tube 110 can be configured to translate proximally, thereby causing the marked distal segment 114 to exit the proximal tube 100 and become visible to the operator of the delivery system 10.

[0034] When the delivery system 10 is assembled, the flexible tube 550 and the sleeve 500 may be more flexible than the distal tube 570 and the proximal tube 100. One way to measure flexibility is to perform a three-point bend test, where a portion of the delivery system 10 is held in a state fixed at two end points, a force is applied perpendicular to the delivery system 10 at the center between the points, and the flexibility is quantified by the length of the deflection of the delivery system 10 caused by the force. When measured in this way, in some embodiments, the flexible tube 550 and the sleeve 500 can be approximately 1.5 times more flexible than the distal tube 570 and approximately 20 times more flexible than the proximal tube 100. That is, when the three-point test is performed in the same way on the three segments 100, 550, 570, the flexible tube 550 can deflect over a length approximately 1.5 times the deflection length of the distal tube 570 and approximately 20 times the deflection length of the proximal tube 100. Flexibility can be measured in other ways, as will be recognized and understood by those skilled in the art.

[0035] According to some embodiments, the distal tube 570 can include a compressible distal portion 300 (as shown in more detail by FIGS. 8A-8D), which can be formed from a helical cutout portion of the distal tube 570 that is compressed and formed by a laser cutting operation. Additionally or alternatively, the compressible distal portion 300 can be formed of a winding, a helical ribbon, or other configuration that allows for axial adjustment according to the present invention. Preferably, the compressible distal portion 300 is in an elongated state at rest and automatically or elastically returns from a compressed state to an elongated state unless otherwise constrained. In some embodiments, the loop wire 400 is effective to hold the compressed distal portion 300 in a compressed state while the implant 12 is being delivered to the treatment site. Alternatively, the distal tube 570 may lack the compressible spring structure 300.

[0036] The pull wire 140 can be constructed from any suitable material. For example, the pull wire 140 can be constructed from a shape memory material such as stainless steel or nitinol. According to some embodiments, the pull wire 140 can be further coated with polytetrafluoroethylene (PTFE).

[0037] FIGS. 2A-2C are illustrations of an exemplary handle member 50 according to aspects of the present disclosure. The deployment handle 50 can include components as described in co-pending U.S. Patent Application No. 17 / 564,764, which is hereby incorporated by reference in its entirety as if fully set forth herein. As will be understood by those skilled in the art, various types of handle members can be used to retract the support tube 110 and the pull wire 140.

[0038] FIG. 2A is a top perspective view of the handle member 50 from the distal end, FIG. 2B is a bottom cutaway view of the handle member 50 from the proximal end, and FIG. 2C is a top perspective view of the handle member 50 from the proximal end. The exemplary handle member 50 can include a handle button 52, an aperture 54, and a handle channel 56. The handle member can have a length L that extends from the proximal end of the handle member 50 to the distal end of the handle member 50. According to some aspects of the present disclosure, the length L of the handle member 50 can be about 10 cm to 20 cm.

[0039] The handle channel 56 seen at the bottom of the handle member 50a can be configured to engage with the proximal support tube 110 and can have a length sufficient to engage with the length of the proximal support tube 110. The aperture 54 has a diameter sufficient to fit over the proximal support tube 110 through its interior. The proximal support tube 110 is configured to pass through the aperture 54 when engaging the handle member 50 at the handle channel 56.

[0040] The handle button 52 can be configured to be pushed by an operator of the delivery system 10. When the handle button 52 is pressed (e.g., toward the bottom surface of the handle member 50), the proximal support tube 110 can be pressed against the upper surface of the handle channel 56, which can retract the support tube 110 and the pull wire 140, thereby deploying the implant 12. When the proximal end of the delivery system 10 is removed from the handle 50, the marked distal segment 114 of the support tube 110 can become visible to the operator. The marked distal segment 114 provides the operator with a visual indication that the delivery system 10 is being properly operated to deploy the implant 12.

[0041] Figures 3-6 illustrate the use of a delivery system 10 having another exemplary handle 50. The operator slides the handle button 52 proximally, thereby detaching the implant from the deployment system 10, exposing the marked distal section 114 of the proximal support tube 110, and providing the operator with a visual indication that the implant 12 has been successfully detached from the deployment system 10 and deployed at the target location in the patient's vasculature.

[0042] Figure 3 illustrates the deployment handle 50 and the delivery system 10 in a state where they are not connected. The proximal direction (P) and the distal direction (D) are illustrated. The proximal tube 100 can have a proximal support tube 110 extending therefrom in the proximal direction (P). The proximal support tube 110 can be configured to be inserted into the aperture 54 of the handle member 50. As shown, the handle member 50 can include a handle button 52, which enables the operator of the delivery system 10 and the handle member 50 to engage the proximal support tube 110 with respect to the handle channel 56, such that while the handle button 52 is depressed, the proximal support tube 110 can be translated proximally in the proximal direction (P) by the operator sliding the handle button 52. The proximal translation of the proximal support tube 110 can translate the pull wire 140 proximally, thereby releasing the implant 12 from the delivery system 10. As shown in Figure 3, since the implant 12 has not yet been deployed from the delivery system 10, the marked distal section 114 of the proximal support tube 110 is not visible.

[0043] Figure 4 illustrates the deployment handle and the delivery system in a connected state. As shown, the operator of the handle 50 and the delivery system 10 can connect the proximal support tube 110 extending from the proximal tube 100 by inserting the proximal support tube 110 into the aperture 54 of the handle member 50. The proximal support tube 110 can be inserted into the aperture 54 of the handle member 50 until the proximal support tube 110 extends completely through a handle channel similar to the handle channel 56, as described with respect to Figures 2A-2C.

[0044] FIG. 5 illustrates the deployment handle and delivery system when the deployment handle is used to deploy the implant 12 from the delivery system 10. After the proximal support tube 110 is inserted through the aperture 54 and extends completely within the handle channel 56, the operator can slide the handle button 52 proximally. When the handle button 52 is slid proximally, the proximal support tube 110 can slide proximally. As the proximal support tube 110 slides proximally, the pull wire 140 can translate proximally with the proximal translation of the proximal support tube 110. The proximal translation of the pull wire 140 can deploy the implant 12 from the delivery system 10. In some examples, a proximal shift of about 6 mm to about 12 mm may be effective to deploy the implant 12 from the delivery system 10. In some examples, moving the handle button 52 proximally by about 6 mm to about 12 mm can translate the proximal support tube 110 and the pull wire 140 proximally by about 6 mm to about 12 mm, which can deploy the implant 12 from the delivery system 10. Alternatively, the handle 50 may include a shuttle system that moves the proximal support tube 110 a greater distance than the distance the handle button 52 travels.

[0045] FIG. 6 shows the deployment handle and delivery system in a disconnected state after the implant 12 has been deployed. After translating the implant 12 from the delivery system 10 by translating the proximal support tube 110 and the pull wire 140 proximally, the marked distal section 114 can be exposed to the operator of the handle 50 and the delivery system 10. In some examples, the marked distal section 114 can be created by laser etching the distal portion of the proximal support tube 110 to create a marked distal section 114 that is visually distinguishable from the remainder of the proximal support tube 110. In some examples, the marked distal section 114 can be created by an anodization process applied to the distal portion of the proximal support tube 110 to create a marked distal section 114 that is visually distinguishable from the remainder of the proximal support tube 110. In some examples, the marked distal section 114 can be created by applying a color printing process to the distal portion of the proximal support tube 110 to create a marked distal section 114 that is visually distinguishable from the remainder of the proximal support tube 110. In some examples, the marked distal section 114 can be created by dipping the distal portion of the proximal support tube 110 into respective paint colors to create a marked distal section 114 that is visually distinguishable from the remainder of the proximal support tube 110. In some examples, the marked distal section 114 can be of a first color, while the remainder of the proximal support tube can be of a second color that is visually distinguishable from the first color.

[0046] FIG. 7 is an illustration of an embolization implant 12 delivered through a catheter 250 and positioned within an aneurysm A of a blood vessel BV. The implant 12 can loop and bend within the aneurysm sac to form a thrombotic mass. The implants can loop back on themselves and / or loop adjacent to other implants. As the aneurysm A becomes increasingly filled, the overlapping portions of the implant 12 can be pushed into each other. As illustrated, the implant 12 includes an embolization coil. As will be understood by those skilled in the art, a plurality of types of implants can be deployed by a pull-wire mechanism. For example, the implant can include a braided embolization, a stent, or a shunt structure.

[0047] FIGS. 8A-8D illustrate the chronological order of steps for releasing the embolization implant 12 from the delivery system 10. The delivery system 10 and the implant 12 can be configured as illustrated in the previous figures and as described herein in other ways. FIG. 8A illustrates an engagement system including a loop wire 400 and a pull wire 140 that are locked to a locking portion 18 of the medical device 12, thereby forming a subassembly. The helical cut 306 of the compressible distal portion 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. When the pull wire 140 is passed through the opening 405, the medical device 12 is fixed at that point. FIG. 8B illustrates the pull wire 140 being pulled proximally to initiate the release sequence of the medical device 12. FIG. 8C illustrates the point at which the distal end 144 of the pull wire 140 exits the opening 405 and the pull wire 140 is pulled without the loop wire 400. The distal end 404 of the loop wire 400 separates and disengages from the locking portion 18. As can be seen from the figure, there is now nothing holding the implant 12 to the detachment system 10. FIG. 8D illustrates the end of the release sequence. Here, the compressible distal portion 300 expands / returns to its original shape and "springs" forward. An elastic force E is applied to the medical device 12 by the distal end 305 of the compressible distal portion 300 to "push out" this, ensuring complete separation and delivery of the medical device 12.

[0048] The compressible distal portion 306 may have a length difference (compression distance) of approximately 0.5 mm to approximately 0.75 mm when measured in the compressed configuration and the original uncompressed configuration. By using a larger compression distance, a larger elastic force E can be achieved. The compression distance can be determined by the dimensions of the loop wire 400, the shape of the locking portion 18, and the shape of the distal end 304 of the compressible distal portion 300.

[0049] FIG. 9 is a flowchart of an exemplary method 900 of using a deployment handle and a delivery system to deploy an implant. At block 904, the method can include providing a tubular body 90 that includes a lumen 608 extending therethrough. At block 908, the method can include extending a pull wire 140 through the lumen 608. At block 912, the method can include providing a proximal support tube 110 disposed within the lumen 608. The proximal support tube 110 can include a marked distal segment 114 that is covered by the tubular body 90. The marked distal segment 114 may not be visible to the operator of the delivery system 10.

[0050] At block 916, the method can include engaging the proximal end 142 of the pull wire 140 with the proximal support tube 110. Proximal translation of the proximal support tube 110 can translate the pull 140 proximally. At block 920, the method can include securing an implantable medical device 12 to the tubular body 90 using the pull wire 140.

[0051] At block 924, the method can include delivering the implantable medical device 12 to a target location in a blood vessel of the body. While delivering the implantable medical device, the marked distal segment n114 can remain covered by the tubular body 90 so as not to be visible to the operator of the delivery system.

[0052] In block 928, the method can include translating the proximal support tube 110 proximally to release the implantable medical device 12 from the distal end 94 of the tubular body 90. The marked distal segment 114 can be moved proximally from the lumen 608 such that the marked distal segment 114 becomes visible to the operator of the delivery system. Thereby, the marked distal segment can effectively indicate that the implantable medical device 12 has been successfully deployed at the target location in the blood vessel of the body.

[0053] The description contained herein is an example of embodiments of the invention and is not intended to limit the scope of the invention in any way. As described herein, the invention contemplates many variations and modifications of the implant system and related methods, including alternative geometric shapes of system components, alternative materials, additional or alternative method steps, and the like. Modifications that are obvious to those skilled in the art are intended to be within the scope of the following claims.

[0054] 〔Embodiments〕 (1) A delivery system for deploying an implantable medical device at a target location in a blood vessel of a body, a tubular body having a lumen extending therethrough, a pull wire extending through the lumen, a proximal support tube disposed within the lumen, the proximal support tube comprising a marked distal segment, the marked distal segment being covered by the tubular body such that the marked distal segment is not visible to the operator of the delivery system, the proximal support tube being configured to engage the proximal end of the pull wire such that proximal translation of the proximal support tube translates the pull wire proximally, thereby releasing the implantable medical device from the distal end of the tubular body, the proximal support tube being configured to move the marked distal segment from the lumen of the tubular body such that the marked distal segment becomes visible upon proximal translation of the proximal support tube that effects release of the implantable medical device. (2) Further comprising a loop wire, the loop wire having a loop opening at a distal portion of the loop wire positioned near the distal end of the tubular body. The delivery system according to Embodiment 1, wherein the loop wire and the pull wire are positioned to secure the implantable medical device to the delivery system. (3) The implantable medical device is deployed in response to proximal translation of the proximal support tube, and by the proximal translation, the distal end of the pull wire exits the loop opening, whereby the loop wire and the pull wire disengage the implantable medical device from the delivery system. The delivery system according to Embodiment 2. (4) The marked distal segment includes laser etching visible to the operator of the delivery system upon deployment of the implantable medical device. The delivery system according to Embodiment 1. (5) The marked distal segment includes an anodized portion of the proximal support tube visible to the operator of the delivery system upon deployment of the implantable medical device. The delivery system according to Embodiment 1.

[0055] (6) The marked distal segment includes a printed or dipped portion of the proximal support tube visible to the operator of the delivery system upon deployment of the implantable medical device. The delivery system according to Embodiment 1. (7) The marked distal segment is clearly distinguishable from the remaining portion of the proximal support tube. The delivery system according to Embodiment 1. (8) The remaining portion of the proximal support tube includes a first color, and the marked distal segment includes a second color distinguishable from the first color. The delivery system according to Embodiment 1. (9) Proximal translation of the proximal support tube of about 6 millimeters to about 12 millimeters exposes the marked distal segment. The delivery system according to Embodiment 1. (10) The proximal translation of the proximal support tube from about 6 millimeters to about 12 millimeters is effective for deploying the implantable medical device, the delivery system according to Embodiment 1.

[0056] (11) The tubular body a proximal tube, a flexible tube distal to the proximal tube, a distal tube distal to the flexible tube, further comprising the delivery system according to Embodiment 1. (12) The flexible tube comprises an interference cut, the delivery system according to Embodiment 11. (13) The distal tube further comprises a compressed distal portion positioned near the implantable medical device, the compressed distal portion provides an elastic force to the implantable medical device, thereby facilitating the release of the implantable medical device from the delivery system, the delivery system according to Embodiment 11. (14) The compressed distal portion further comprises a helical cut portion of the distal tube, the delivery system according to Embodiment 13. (15) A method for using a delivery system for deploying an implantable medical device to a target location in a blood vessel of a body, providing a tubular body having a lumen extending therethrough, extending a pull wire through the lumen, providing a proximal support tube disposed within the lumen, the proximal support tube comprising a marked distal section, the marked distal section being covered by the tubular body such that the marked distal section is not visible to an operator of the delivery system, providing, engaging the proximal end of the pull wire with the proximal support tube such that proximal translation of the proximal support tube translates the pull wire proximally, fixing the implantable medical device to the tubular body using the pull wire, Delivering the implantable medical device to the target location in the blood vessel of the body while the marked distal segment remains covered by the tubular body; Including translating the proximal support tube proximally to release the implantable medical device from the distal end of the tubular body, thereby moving the marked distal segment proximally out of the lumen so that the marked distal segment is visible. A method.

[0057] (16) The method according to embodiment 15, wherein the marked distal segment includes laser etching visible to the operator of the delivery system during deployment of the implantable medical device. (17) The method according to embodiment 15, wherein the marked distal segment includes an anodized portion of the proximal support tube visible to the operator of the delivery system during deployment of the implantable medical device. (18) The method according to embodiment 15, wherein the marked distal segment includes a printed or dipped portion of the proximal support tube visible to the operator of the delivery system during deployment of the implantable medical device. (19) The method according to embodiment 15, wherein the remaining portion of the proximal support tube includes a first color and the marked distal segment includes a second color distinguishable from the first color. (20) The method according to embodiment 15, wherein a proximal translation of the proximal support tube of about 6 millimeters to about 12 millimeters is effective to expose the marked distal segment and deploy the implantable medical device.

Claims

1. A delivery system for deploying an implantable medical device to a target location in a blood vessel of a body, comprising: a tubular body having a lumen extending therethrough; a pull wire extending through the lumen; a proximal support tube disposed within the lumen, the proximal support tube having a marked distal section, the marked distal section being covered by the tubular body such that the marked distal section is not visible to an operator of the delivery system, the proximal support tube being configured to engage a proximal end of the pull wire such that proximal translation of the proximal support tube translates the pull wire proximally, thereby releasing the implantable medical device from a distal end of the tubular body; The delivery system, wherein the proximal support tube is configured to move the marked distal section out of the lumen of the tubular body such that the marked distal section becomes visible upon proximal translation of the proximal support tube that effects release of the implantable medical device.

2. Further comprising a loop wire having a loop opening at a distal portion of the loop wire positioned near a distal end of the tubular body; The delivery system according to claim 1, wherein the loop wire and the pull wire are positioned to secure the implantable medical device to the delivery system.

3. The delivery system according to claim 2, wherein the implantable medical device is deployed in response to proximal translation of the proximal support tube, and the proximal translation causes a distal end of the pull wire to exit the loop opening, thereby disengaging the loop wire and the pull wire from the implantable medical device from the delivery system.

4. The delivery system according to claim 1, wherein the marked distal section includes a laser etching visible to the operator of the delivery system upon deployment of the implantable medical device.

5. The delivery system according to claim 1, wherein the marked distal section includes an anodized portion of the proximal support tube visible to the operator of the delivery system upon deployment of the implantable medical device.

6. The delivery system according to claim 1, wherein the marked distal section includes a printed or dipped portion of the proximal support tube visible to the operator of the delivery system upon deployment of the implantable medical device.

7. The delivery system according to claim 1, wherein the marked distal section is clearly distinguishable from the remainder of the proximal support tube.

8. The delivery system according to claim 1, wherein the remainder of the proximal support tube includes a first color and the marked distal section includes a second color distinguishable from the first color.

9. The delivery system according to claim 1, wherein proximal translation of the proximal support tube of from about 6 millimeters to about 12 millimeters exposes the marked distal section.

10. The delivery system according to claim 1, wherein proximal translation of the proximal support tube of from about 6 millimeters to about 12 millimeters is effective to deploy the implantable medical device.

11. The tubular body further comprises a proximal tube, a flexible tube distal to the proximal tube, and a distal tube distal to the flexible tube, the delivery system according to claim 1.

12. The delivery system according to claim 11, wherein the flexible tube comprises interference cuts.

13. The distal tube further comprises a compressed distal portion positioned near the implantable medical device, the compressed distal portion providing an elastic force to the implantable medical device, thereby facilitating release of the implantable medical device from the delivery system, the delivery system according to claim 11.

14. The delivery system according to claim 13, wherein the compressed distal portion further comprises a helical cut portion of the distal tube.

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