Disengagement indicator for implant deployment

By designing a delivery system including a tubular body, pulling wire and proximal support tube, the problem of difficulty in visually confirming the success of implant deployment in the prior art is solved, and effective deployment instructions and improved deployment reliability are achieved.

CN119403499APending Publication Date: 2025-02-07DEPUY SYNTHES PROD INC
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Patent Information

Application Number
CN202380048293.8
Authority / Receiving Office
CN · China
Patent Type
Applications(China)
Current Assignee / Owner
Priority Date
2022-06-23
Filing Date
2023-06-23
Publication Date
2025-02-07

AI Technical Summary

Technical Problem

Existing intravascular implant device deployment systems have difficulty visually determining whether the implant has been successfully deployed, especially due to the slight length variation, which makes it difficult for the physician to confirm the completion of the disengagement cycle.

Method used

A delivery system is designed, which includes a tubular body, a pull wire and a proximal support tube. By proximal translation of the proximal support canal, the pulling wire translates proximal to release the implantable medical device and provides a visual indication by exposure of the marked distal section to confirm that the implant has been successfully deployed.

Benefits of technology

The system is able to effectively provide the physician with visual indication that the implant has been successfully deployed, improving the reliability and accuracy of the deployment process.

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Abstract

A delivery system for deploying an implantable medical device to a target location of a body vessel may include: a tubular body having a lumen extending therethrough; a pulling wire, wherein the pulling wire extends to pass through the tube cavity; and a proximal support tube disposed within the lumen and engaged to the pull wire such that proximal translation of the support tube causes proximal translation of the pull wire. The proximal support tube may include a marked distal section that is invisible to an operator of the delivery system prior to release of the implant and becomes visible when the proximal support tube is proximally pulled a sufficient distance to cause the delivery system to release the implant.
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Description

Technical Field

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

[0002] Many intravascular implant devices are known in the art. Many devices are mechanically deployed via a system combining one or more catheters and lines for delivery. Examples of implants that can be mechanically delivered include embolic elements, stents, grafts, drug delivery implants, deflection elements, filters, stimulation leads, sensing leads, or other implantable structures delivered by microcatheters. The physician wishes to feedback that the detachment cycle has been completed correctly. In most mechanical delivery systems, the inner tube is held in the lumen of the delivery system push rod and is attached to the inner wire that travels along the length of the device. When pulled, the inner wire translates backward to detach from the implant. In conventional systems, the mark that the detachment cycle has been completed is that the inner tube has translated and therefore the length has increased. However, in conventional deployment systems, it is difficult for physicians to visually determine whether the implant has been successfully deployed because it is difficult to visually determine the slight changes in length.

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

[0004] Various exemplary systems, devices, and methods of the present disclosure that can address the above needs are disclosed herein. Examples may generally include a delivery system for deploying an implantable medical device to a target location in a body vessel. The delivery system may include a tubular body including a lumen extending through the tubular body. The delivery system may include a puller wire extending through the lumen. The delivery system may include a proximal support tube disposed within the lumen. The proximal support tube may include a distal segment of a mark covered by the tubular body so that the distal segment of the mark is not visible to an operator of the delivery system. The proximal support tube may be configured to engage the proximal end of the puller wire so that the proximal translation of the proximal support tube causes the puller wire to translate toward the proximal side, thereby releasing the implantable medical device from the distal end of the tubular body. The proximal support tube may be configured so that the proximal translation of the proximal support tube that causes the release of the implantable medical device moves the distal segment of the mark from the lumen of the tubular body so that the distal segment of the mark is visible.

[0005] The delivery system may further include a loop wire including a loop opening at a distal portion of the loop wire positioned proximate to 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, which can cause the distal end of the puller wire to exit the loop opening, which can cause the loop wire and the puller wire to disengage the medical device from the delivery system.

[0007] The marked distal section may include laser etching that is visible to an operator of the delivery system when deploying the implantable medical device.

[0008] The marked distal section may include an anodized portion of the proximal support tube that is visible to an operator of the delivery system when deploying the implantable medical device.

[0009] The marked distal section may include a printed or impregnated portion of the proximal support tube that is visible to an operator of the delivery system when deploying the implantable medical device.

[0010] The marked distal section may be visually distinguishable from the remainder of the proximal support tube.

[0011] The remainder of the proximal support tube may include a first color, and the marked distal section may include a second color distinguishable from the first color.

[0012] The proximal translation of the proximal support tube may be between about 6 mm and about 12 mm to expose a distal portion of the marker.

[0013] The proximal translation of the proximal support tube may be between about 6 mm and about 12 mm to deploy the implantable medical device.

[0014] The tubular body may 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 may include an interference cutout.

[0016] The distal tube may also include a compressed distal portion positioned proximate to the implantable medical device. The compressed portion may provide a spring force against the implantable medical device, thereby facilitating the release of the implantable medical device from the delivery system.

[0017] The compressed distal portion may include a helically cut portion of the distal tube.

[0018] In another aspect, a method for deploying an implantable medical device to a target location in a body vessel using a delivery system is disclosed. The method may include providing a tubular body. The tubular body may include a lumen extending through the tubular body. The method may include extending a puller wire through the lumen. The method may include providing a proximal support tube disposed within the lumen. The proximal support tube may 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 may include engaging the proximal end of the puller wire to the proximal support tube, such that proximal translation of the proximal support tube causes the puller wire to translate proximally. The method may include securing the implantable medical device to the tubular body with the puller wire. The method may include delivering the implantable medical device to a target location in a body vessel while the marked distal segment remains covered by the tubular body. The method may include 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, such that the marked distal segment is visible.

[0019] The marked distal section may include laser etching that is visible to an operator of the delivery system when deploying the implantable medical device.

[0020] The marked distal section may include an anodized portion of the proximal support tube that is visible to an operator of the delivery system when deploying the implantable medical device.

[0021] The marked distal section may include a printed or impregnated portion of the proximal support tube that is visible to an operator of the delivery system when deploying the implantable medical device.

[0022] The remainder of the proximal support tube may include a first color, and the marked distal section may include a second color distinguishable from the first color.

[0023] Proximal translation of the proximal support tube between about 6 millimeters and about 12 millimeters exposes the distal portion of the marker and enables effective deployment of the implantable medical device. BRIEF DESCRIPTION OF THE DRAWINGS

[0024] The above aspects and additional aspects of the present invention will be further discussed with reference to the following description and in conjunction with the accompanying drawings, in which like numbers indicate similar structural elements and features in the various figures. The accompanying drawings are not necessarily drawn to scale, but instead, emphasis is placed on illustrating the principles of the present invention. The accompanying drawings depict one or more specific implementations of the present invention by way of example only and not by way of limitation.

[0025] Figure 1 is a diagrammatic representation of a delivery system and implant according to aspects of the present invention.

[0026] FIG. 2A to FIG. 2CThe deployment handle and delivery system are illustrated in an unconnected state.

[0027] Figure 3 The deployment handle and delivery system are illustrated in an unconnected state.

[0028] Figure 4 The deployment handle and delivery system are illustrated in a connected state.

[0029] Figure 5 The deployment handle and delivery system are illustrated as the deployment handle is used to deploy an implant from the delivery system.

[0030] Figure 6 The deployment handle and delivery system are shown in an unconnected state after implant deployment.

[0031] Figure 7 is an illustration of an embolic coil positioned within an aneurysm in accordance with aspects of the present invention.

[0032] FIG. 8A to FIG. 8D A sequence of steps for releasing an implant from a delivery system according to aspects of the present invention is illustrated.

[0033] Fig. 9 is a flow chart of an exemplary method of deploying an implant using a deployment handle and a delivery system. DETAILED DESCRIPTION

[0034] The following description of certain examples of the present invention should not be used to limit the scope of the present invention. The accompanying drawings (not necessarily drawn to scale) depict selected embodiments and are not intended to limit the scope of the present invention. The detailed description illustrates the principles of the present invention by way of example and not by way of limitation. From the following description, other examples, features, aspects, embodiments and advantages of the present invention will become apparent to those skilled in the relevant art, and the following description is by way of example, which is one of the best ways contemplated for implementing the present invention. As will be appreciated, the present invention can have other different or equivalent aspects, all of which do not depart from the present invention. Therefore, the drawings and description should be considered to be illustrative and not restrictive in nature.

[0035] Any one or more of the teachings, expressions, patterns, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, patterns, examples, etc. described herein. Therefore, the following teachings, expressions, patterns, examples, etc. should not be considered separate from each other. With reference to the teachings herein, various suitable ways in which the teachings herein may be combined will be apparent to those skilled in the relevant art. Such modifications and variations are intended to be included within the scope of the claims.

[0036] As used herein, the term "about" or "approximately" for any numerical value or range indicates a suitable dimensional tolerance that allows a collection of parts or components to achieve its intended purpose as described herein. More specifically, "about" or "approximately" may refer to a range of ±10% of the value of the recited value, for example, "about 90%" may refer to a range of values ​​from 81% to 99%. In addition, as used herein, the terms "patient", "recipient", "user" and "subject" refer to any human or animal subject, and are not intended to limit the system or method to human use, but the use of the subject invention in human patients represents a preferred embodiment.

[0037] Turning to the attached figure, Figure 1 An exemplary delivery system 10 for deploying an implantable medical device 12 to a target location in a body vessel is shown. The exemplary delivery system 10 may include a proximal tube 100, a flexible tube 550 positioned distal to the proximal tube 100, and a distal tube 570 positioned distal to the flexible tube 550. The proximal tube 100, the flexible tube 550, and the distal tube 570 may collectively have a lumen 608 extending through them. 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. The proximal tube 100, the flexible tube 550, and the distal tube 570 may be collectively referred to as a tubular body 90. The tubular body may include a proximal end 92 and a distal end 94, as shown in FIG. Figure 1 As shown in . Implant 12 can be positioned distally of distal tube 570.

[0038] The flexible tube 550 may include a coiled wire, a support coil, attached at each end to the proximal tube 110 and the distal tube 570, respectively. Alternatively, the flexible tube 550 may include a laser cut hypotube including an interference cut 560, such as Figure 1 . In this example, the flexible tube 550 is preferably continuous with the proximal tube 100 and the distal tube 570 so that the tubes 100, 550, 570 are formed by a single hypotube. The interference cutout 560 can provide a high level of flexibility for the flexible tube 550. The sleeve 500 can surround the flexible tube 550 to provide a smooth outer surface of the delivery system 10 on the flexible tube 550.

[0039] 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 support for the flexible tube 550. In some examples, the inner support tube 510 can prevent the flexible tube 550 from stretching. The inner support tube 510 is optional if interference cuts are made to allow the flexible tube 550 to have sufficient structural support without the support tube 510, or if other features are included to provide structural support to the flexible tube 550.

[0040] 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 as 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 size of the pull wire bead 142 can be set so that the pull wire bead 142 is larger than the space between the proximal support tubes 110, so 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. Alternatively, the proximal end of the puller wire may be welded to or otherwise joined to the proximal tube 110 , as will be understood by those skilled in the relevant art(s).

[0041] The loop opening 405 of the loop 400 (also related to FIG. 8A to FIG. 8D 140 ) can be located at the distal portion 404 of the loop 400 and can extend through the locking member 18 of the implant 12. The distal end 144 of the puller wire 140 can be positioned through the loop opening 405 of the loop 400 to fix the implant 12 to the delivery system 10. The proximal ends 406, 408 of the loop can be attached to the distal tube 570, as shown. Additionally or alternatively, one or both of the proximal ends 406, 408 of the loop can be attached to the proximal tube 100 to provide structural support to the flexible tube 550. Additionally or alternatively, the proximal ends 406, 408 of the loop can be attached to the puller wire 140. In this example, the loop 400 can be made of an elastic material so that the proximal translation of the puller wire 140 can cause the loop 400 to stretch and become tensioned, which provides resistance to further proximal translation of the puller wire 140. The loop 400 can effectively prevent the implant 12 from being removed from the delivery system 10 prematurely.

[0042] The proximal support tube 110 may include a marked distal section 114 located within the proximal tube 100. When the implant 12 is delivered to a target location in a patient, the marked distal section 114 may be configured to be hidden from view by an operator of the delivery system 10. When the pull wire 140 is pulled proximally a distance sufficient to disengage the implant 12, the proximal support tube 110 may be configured to translate proximally, thereby causing the marked distal section 114 to leave the proximal tube 100 and become visible to the operator of the delivery system 10.

[0043] When the delivery system 10 is assembled, the flexible tube 550 and the sleeve 500 can be more flexible than the distal tube 570 and the proximal tube 100. One way to measure flexibility is to perform a three-point bending test, in which a portion of the delivery system 10 is held fixed at two end points, a force is applied perpendicular to the delivery system 10 at an intermediate position between these points, and the flexibility is quantified by the deflection length of the delivery system 10 caused by the force. When measured in this manner, in some examples, the flexibility of the flexible tube 550 and the sleeve 500 can be about 1.5 times the flexibility of the distal tube 570 and about 20 times the flexibility of the proximal tube 100. That is, when the three-point test is performed on the three sections 100, 550 and 570 in the same manner, the flexible tube 550 can be deflected to a length that is about 1.5 times the deflection length of the distal tube 570 and about 20 times the deflection length of the proximal tube 100. As will be known and understood by those skilled in the art, flexibility can be measured in other ways.

[0044] According to some embodiments, the distal tube 570 may include a compressible distal portion 300 (eg, FIG. 8A to FIG. 8D ), the compressible distal portion can be compressed and formed by a spiral cut portion of the distal tube 570 formed by a laser cutting operation. In addition or alternatively, the compressible distal portion 300 can be formed by a wound wire, a spiral band, or other arrangements that allow axial adjustment according to the present invention. Preferably, unless otherwise limited, the compressible distal portion 300 is in an extended state when stationary and automatically or elastically returns to the extended state from a compressed state. In some embodiments, when the implant 12 is delivered to the treatment site, the loop 400 can effectively keep the compressed distal portion 300 in a compressed state. Alternatively, the distal tube 570 may not have a compressible spring structure 300.

[0045] The puller wire 140 may be constructed of any suitable material, for example, the puller wire 140 may be constructed of stainless steel or a shape memory material such as Nitinol. According to some embodiments, the puller wire 140 may additionally be coated with polytetrafluoroethylene (PTFE).

[0046] FIG. 2A to FIG. 2C is an illustration of an exemplary handle member 50 according to aspects of the present disclosure. The deployment handle 50 may include components as described in pending U.S. Application No. 17 / 564,764, which is incorporated herein by reference as if its entire contents were included. As will be appreciated by those skilled in the relevant art, a variety of types of handle members may be used to retract the support tube 110 and the puller wire 140.

[0047] Figure 2A is a top perspective view of the handle member 50 from the distal end, Figure 2B is an undercut view of the handle member 50 from the proximal end, and Figure 2C 5 is a top perspective view of the handle member 50 from the proximal end. An exemplary handle member 50 may include a handle button 52, an orifice 54, and a handle channel 56. The handle member may have a length L extending 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 may be approximately between 10 cm and 20 cm.

[0048] The handle channel 56 found on 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 to the length of the proximal support tube 110. The aperture 54 has a diameter sufficient to fit the proximal support tube 110 through the aperture. The proximal support tube 110 is configured to pass through the aperture 54 when engaged to the handle member 50 at the handle channel 56.

[0049] The handle button 52 can be configured to be pressed 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 top surface of the handle channel 56, which can cause the support tube 110 and the puller wire 140 to retract, thereby deploying the implant 12. When the proximal end of the delivery system 10 is removed from the handle 50, the marked distal section 114 of the support tube 110 can be visible to the operator. The marked distal section 114 provides a visible indication to the operator that the delivery system 10 has been properly manipulated to deploy the implant 12.

[0050] Figures 3 to 6 The use of the delivery system 10 is illustrated with another exemplary handle 50. The operator can slide the handle button 52 proximally, thereby detaching the implant from the deployment system 10 and exposing the marked distal section 114 of the proximal support tube 110 to provide the operator with a visual indication that the implant 12 has been successfully detached from the deployment system 10 and deployed in the target location of the patient's vasculature.

[0051] Figure 3 The deployment handle 50 and the delivery system 10 in an unconnected state with the handle 50 are illustrated. The proximal direction (P) and the distal direction (D) are indicated in the illustration. The proximal tube 100 may have a proximal support tube 110 extending therefrom in the proximal direction (P). The proximal support tube 110 may be configured to be inserted into the orifice 54 of the handle member 50. As shown, the handle member 50 may include a handle button 52 that allows an operator of the delivery system 10 and the handle member 50 to engage the proximal support tube 110 against the handle channel 56, so that when the handle button 52 is pressed, the proximal support tube 110 can be translated proximally by the operator sliding the handle button 52 in the proximal direction (P). The proximal translation of the proximal support tube 110 can cause the pull wire 140 to translate proximally, thereby releasing the implant 12 from the delivery system 10. Figure 3 As shown in FIG. 1 , the labeled distal section 114 of the proximal support tube 110 is not visible because the implant 12 has not yet been deployed from the delivery system 10 .

[0052] Figure 4 The deployment handle and delivery system are illustrated in a connected state. As shown, an operator of the handle 50 and 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 orifice 54 of the handle member 50. The proximal support tube 110 can be inserted into the orifice 54 of the handle member 50 until the proximal support tube 110 is fully extended through the handle channel similar to the handle channel 56, as described with reference to FIG. FIG. 2A to FIG. 2C as described.

[0053] Figure 5 The deployment handle and delivery system when the deployment handle is used to deploy the implant 12 from the delivery system 10 are illustrated. After the proximal support tube 110 is inserted through the orifice 54 and fully extends into the handle channel 56, the operator can slide the handle button 52 proximally. When the handle button 52 slides proximally, the proximal support tube 110 can slide proximally. When the proximal support tube 110 slides proximally, the pull wire 140 can translate proximally as the proximal support tube 110 translates proximally. The proximal translation of the pull wire 140 can deploy the implant 12 from the delivery system 10. In some examples, the proximal displacement between about 6mm and about 12mm can effectively deploy the implant 12 from the delivery system 10. In some examples, proximal movement of the handle button 52 by about 6 mm to about 12 mm can cause the proximal support tube 110 and the puller wire 140 to translate proximally by about 6 mm to about 12 mm, which can cause the implant 12 to be deployed from the delivery system 10. Alternatively, the handle 50 can include a shuttle system to move the proximal support tube 110 a greater distance than the distance traveled by the handle button 52.

[0054] Figure 6The deployment handle and delivery system are shown in an unconnected state after deployment of the implant 12. After the proximal support tube 110 and the puller wire 140 are translated proximally to deploy the implant 12 from the delivery system 10, the marked distal segment 114 can be exposed to an operator of the handle 50 and the delivery system 10. In some examples, the marked distal segment 114 can be produced by laser etching the distal portion of the proximal support tube 110 so as to produce a marked distal segment 114 that is visually different from the remainder of the proximal support tube 110. In some examples, the marked distal segment 114 can be produced by an anodizing process applied to the distal portion of the proximal support tube 110 so as to produce a marked distal segment 114 that is visually different from the remainder of the proximal support tube 110. In some examples, the marked distal section 114 may be produced by applying a color printing process to the distal portion of the proximal support tube 110 to produce a marked distal section 114 that is visually distinct from the remainder of the proximal support tube 110. In some examples, the marked distal section 114 may be produced by dipping the distal portion of the proximal support tube 110 into a corresponding paint color to produce a marked distal section 114 that is visually distinct from the remainder of the proximal support tube 110. In some examples, the marked distal section 114 may be a first color, while the remainder of the proximal support tube may be a second color that is visually distinct from the first color.

[0055] Figure 7 2 is a diagram of an embolic implant 12 delivered by a catheter 250 and positioned within an aneurysm A on a blood vessel BV. The implant 12 can be looped with the aneurysm sac and bent to form a thrombus mass. The implant can loop back on itself and / or be looped adjacent to other implants. As the aneurysm A becomes more and more accumulated, the overlapping portions of the implant 12 can be pressed into each other. As shown, the implant 12 includes an embolic coil. As will be appreciated by those skilled in the relevant art, various types of implants can be deployed via a pull-wire mechanism. For example, the implant can include an embolic braid, a stent, or a flow diversion element structure.

[0056] FIG. 8A to FIG. 8D Illustrated is a timing of the steps of releasing the embolic implant 12 from the delivery system 10. The delivery system 10 and implant 12 may be configured such as shown in the previous figures and otherwise described herein. Fig. 8A An engagement system including a loop 400 and a puller wire 140 that are locked into the locking portion 18 of the medical device 12 to form a subassembly is illustrated. The helical cutout 306 of the compressible distal portion 300 can be compressed, and the loop 400 opening 405 at the distal end 404 of the loop 400 can be placed through the locking portion 18. When the puller wire 140 is passed through the opening 405, the medical device 12 is now fixed. Figure 8BPulling the pull wire 140 proximally to initiate a release sequence of the medical device 12 is illustrated. Figure 8C The moment when the distal end 144 of the puller wire 140 leaves the opening 405 and the puller wire 140 is pulled out of the loop wire 400 is illustrated. The distal end 404 of the loop wire 400 is disengaged and disengaged from the locking portion 18. It can be seen that there is now nothing holding the implant 12 out of the system 10. Fig.8D The end of the release sequence is illustrated. Here, the compressible distal portion 300 has extended / recovered to its original shape and "popped" forward. The distal end 305 of the compressible distal portion 300 applies a spring force E to the medical device 12 to "push it away", thereby ensuring complete separation and delivery of the medical device 12.

[0057] When measured in the compressed configuration and the initial uncompressed configuration, the compressible distal portion 306 may have a length difference (compression distance) of about 0.5 mm to about 0.75 mm. A greater elastic force E may be achieved by using a greater compression distance. The compression distance may be determined by the size of the loop 400, the shape of the locking portion 18, and the shape of the distal end 304 of the compressible distal portion 300.

[0058] Fig. 9 is a flow chart of an exemplary method 900 for deploying an implant using a deployment handle and a delivery system. In box 904, the method may include providing a tubular body 90 including a lumen 608 extending through the tubular body. In box 908, the method may include extending a puller wire 140 through the lumen 608. In box 912, the method may include providing a proximal support tube 110 disposed within the lumen 608. The proximal support tube 110 may include a marked distal segment 114 covered by the tubular body 90. The marked distal segment 114 may not be visible to an operator of the delivery system 10.

[0059] In frame 916, the method may include coupling the proximal end 142 of the puller wire 140 to the proximal support tube 110. Proximal translation of the proximal support tube 110 may cause the puller wire 140 to translate proximally. In frame 920, the method may include securing the implantable medical device 12 to the tubular body 90 with the puller wire 140.

[0060] In block 924, the method may include delivering the implantable medical device 12 to a target location in a body vessel. While delivering the implantable medical device, the marked distal section 114 may remain covered by the tubular body 90 so that it is not visible to an operator of the delivery system.

[0061] In frame 928, the method may 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 may be moved proximally out of the lumen 608 so that the marked distal segment 114 becomes visible to an operator of the delivery system. The marked distal segment may thereby effectively indicate that the implantable medical device 12 has been successfully deployed at the target location of the body vessel.

[0062] The description contained herein is an example of an embodiment of the present invention, and is not intended to limit the scope of the present invention in any way. As described herein, the present invention contemplates many variations and modifications of implant systems and related methods, including alternative geometries of system components, alternative materials, additional or alternative method steps, etc. Modifications that are obvious to those skilled in the relevant art are intended to be within the scope of the appended claims.

Claims

1. A delivery system for deploying an implantable medical device to a target location in a body vessel, the delivery system comprising: a tubular body comprising a lumen extending therethrough; a puller wire extending through the lumen; and a proximal support tube disposed within the lumen, the proximal support tube including a marked distal section 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 puller wire such that proximal translation of the proximal support tube causes proximal translation of the puller wire to release the implantable medical device from the distal end of the tubular body, Wherein the proximal support tube is configured such that proximal translation of the proximal support tube resulting in release of the implantable medical device moves the marked distal segment from the lumen of the tubular body such that the marked distal segment is visible.

2. The delivery system according to claim 1, further comprising: a loop wire including a loop opening at a distal portion of the loop wire positioned proximate the distal end of the tubular body, Wherein the loop wire and the pull wire are positioned to secure the implantable medical device to the delivery system.

3. A delivery system according to claim 2, wherein the implantable medical device is deployed in response to proximal translation of the proximal support tube, the proximal translation causing the distal end of the pull wire to leave the ring opening, which causes the ring wire and the pull wire to disengage the implantable medical device from the delivery system.

4. The delivery system of claim 1, wherein the marked distal section comprises laser etching that is visible to the operator of the delivery system when deploying the implantable medical device.

5. The delivery system of claim 1, wherein the marked distal section comprises an anodized portion of the proximal support tube, the anodized portion being visible to the operator of the delivery system when deploying the implantable medical device.

6. The delivery system of claim 1, wherein the marked distal section comprises a printed or impregnated portion of the proximal support tube that is visible to the operator of the delivery system when deploying the implantable medical device.

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

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

9. The delivery system of claim 1, wherein proximal translation of the proximal support tube between about 6 millimeters and about 12 millimeters exposes the marked distal segment.

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

11. The delivery system of claim 1, wherein the tubular body further comprises: proximal tube; a flexible tube located distal to the proximal tube; and A distal tube is located distal to the flexible tube.

12. The delivery system of claim 11, wherein the flexible tube comprises an interference cutout.

13. The delivery system of claim 11, wherein: The distal tube also includes a compressed distal portion positioned proximate the implantable medical device; and The compressed distal portion provides a spring force against the implantable medical device, thereby facilitating release of the implantable medical device from the delivery system.

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

15. A method for deploying an implantable medical device to a target location in a body vessel using a delivery system, the method comprising: providing a tubular body comprising a lumen extending through the tubular body; extending a puller wire through the lumen; providing a proximal support tube disposed within the lumen, the proximal support tube including a marked distal section covered by the tubular body such that the marked distal section is not visible to an operator of the delivery system; engaging a proximal end of the puller wire to the proximal support tube such that proximal translation of the proximal support tube causes proximal translation of the puller wire; securing the implantable medical device to the tubular body using the puller wire; delivering the implantable medical device to the target location in the body vessel while the marked distal segment remains covered by the tubular body; as well as The proximal support tube is translated 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.

16. The method of claim 15, wherein the marked distal section comprises laser etching that is visible to the operator of the delivery system when deploying the implantable medical device.

17. The method of claim 15, wherein the marked distal section comprises an anodized portion of the proximal support tube, the anodized portion being visible to the operator of the delivery system when deploying the implantable medical device.

18. The method of claim 15, wherein the marked distal section comprises a printed or impregnated portion of the proximal support tube, the printed or impregnated portion being visible to the operator of the delivery system when deploying the implantable medical device.

19. The method of claim 15, wherein the remainder of the proximal support tube comprises a first color and the marked distal section comprises a second color distinguishable from the first color.

20. The method of claim 15, wherein proximal translation of the proximal support tube between about 6 millimeters and about 12 millimeters exposes the marked distal segment and enables effective deployment of the implantable medical device.

Citation Information

Patent Citations

  • Systems and methods for embolic implant deployment

    US20230200819A1