Interference features to prevent premature embolic implant detachment - Patents.com
The dissociation system addresses the issue of premature implant release in catheter-based delivery systems by using interference features that crush upon proximal translation of the inner tubular body, ensuring secure implant delivery through tortuous vasculature.
Patent Information
- Application Number
- JP2024554903
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Priority Date
- 2022-03-15
- Filing Date
- 2023-02-24
- Publication Date
- 2025-03-21
AI Technical Summary
Current catheter-based delivery systems for intravascular implants face the challenge of premature dissociation of implants due to increased friction between the pull wire and the delivery system as it navigates through tortuous vasculature.
The proposed solution involves a dissociation system with an outer and inner tubular body, where the pull wire is positioned within both lumens, and interference features extending through a radial lumen to prevent premature implant release. These interference features are designed to crush upon proximal translation of the inner tubular body, facilitating the release of the implant.
This solution effectively prevents premature ablation of the implant during delivery through tortuous vasculature, ensuring that the implant is securely held until it reaches the intended treatment site, where it can be released accurately.
Smart Images

Figure 2025508190000001_ABST
Abstract
Description
[Technical field]
[0001] The present invention relates to aneurysm treatment devices, and more particularly to an improved delivery system for embolic implants that prevents premature implant deployment. [Background technology]
[0002] Numerous intravascular implant devices are known in the art. Many are mechanically deployed via a system combining one or more catheters and wires for delivery. Examples of implants that can be delivered mechanically include embolic elements, stents, grafts, drug delivery implants, flow diverters, filters, stimulation leads, sensing leads, or other implantable structures delivered through a microcatheter. Some obstetric and gastrointestinal implants can also be implanted via a similar system combining one or more catheters and wires. Devices that can be released or deployed by mechanical means vary greatly in design, but can use similar delivery catheter and wire systems. Many such catheter-based delivery systems include a wire to hold the implant within the catheter until the time of device release. These systems are subsequently actuated by retracting or pulling the wire relative to the catheter. Such wires are referred to herein as "pull wires."
[0003] One problem with current catheter-based delivery systems is premature detachment of the implantable device. Premature detachment occurs when the implant detaches from the delivery system before reaching the treatment site. This can occur due to the tortuosity the delivery system undergoes as it passes through the patient's vasculature, which can cause increased friction between the "pull wire" and the delivery system, causing the pull wire to move proximally while the delivery system is moving distally. Summary of the Invention [Problem to be solved by the invention]
[0004] Thus, there is a need for an improved implant delivery system that prevents premature detachment of the implant when the implant is delivered through tortuous vasculature.The present disclosure is directed to this and other considerations. [Means for solving the problem]
[0005] Various systems and methods of delivering an implant are disclosed. The detachment system can include an outer tubular body defining a longitudinal axis including a first lumen and an inner tubular body including a second lumen extending therethrough, the inner tubular body being disposed within the first lumen. A pull wire can be at least partially within the second lumen and at least partially within the first lumen and configured to translate proximally relative to the outer tubular body to release the implant. A radial lumen can extend through the outer tubular body and the inner tubular body orthogonal to the longitudinal axis. An interference feature can extend at least partially through the radial lumen to inhibit premature detachment of the implant. The interference feature can fracture in response to proximal translation of the inner tubular body, thereby facilitating release of the implant.
[0006] In one aspect, a detachment system for delivering an implantable medical device to a targeted location in a body vessel is disclosed. The detachment system can include an outer tubular body including a first lumen extending therethrough along a longitudinal axis. The detachment system can include an inner tubular body including a second lumen extending therethrough along a longitudinal axis. The inner tubular body can be disposed within the first lumen of the outer tubular body. The detachment system can include a pull wire at least partially disposed within the second lumen of the inner tubular body and at least partially disposed within the first lumen of the outer tubular body. The pull wire can be configured to translate proximally relative to the outer tubular body to release the implantable medical device from a distal end of the detachment system. The detachment system can include a radial lumen extending through the outer tubular body and the inner tubular body orthogonal to the longitudinal axis. The detachment system can include an interference feature extending at least partially through the radial lumen. The interference feature can be effective to prevent premature detachment of the implantable medical device when the implantable medical device is delivered to a targeted location in a body vessel by the detachment system. The interference feature can be configured to fracture in response to proximal translation of the inner tubular body, thereby facilitating release of the implantable medical device from the detachment system.
[0007] In some embodiments, the interferometric feature may include a monofilament suture.
[0008] In some embodiments, the interferometric features are constructed from polypropylene 8-0.
[0009] In some embodiments, the interference feature is secured to the outer wall by a method selected from welding the interference feature to the outer wall of the outer tubular body, melting the interference feature to the outer wall, tying the interference feature to the outer wall, and gluing the interference feature to the outer wall.
[0010] In some embodiments, the interference feature prevents proximal translation of the inner tubular body relative to the outer tubular body.
[0011] In some embodiments, the proximal end of the pull wire can be attached to the proximal end of the inner tubular body. The pull wire can be configured to translate with the inner tubular body as a single unit relative to the outer tubular body.
[0012] In some embodiments, the radial lumens can include an outer radial lumen and an inner radial lumen. The outer radial lumen can be aligned with the inner radial lumen when the implantable medical device is delivered to a target location in a body vessel by the detachment system. The inner radial lumen can be configured to move out of alignment with respect to the outer radial lumen, thereby fracturing the interference feature and facilitating release of the implantable medical device from the detachment system.
[0013] In some embodiments, the interference feature may extend through the entire length of the radial lumen, and the interference feature may be secured to the outer wall of the outer tubular body at each end of the radial lumen.
[0014] In some embodiments, the interferometric feature is configured to fracture in response to a force between about 50 grams force and about 100 grams force.
[0015] In some embodiments, the detachment system can further include a loop wire including a loop opening disposed near the distal end of the outer tubular body. The loop wire and the pull wire can be positioned to secure the implantable medical device to the delivery system.
[0016] In some embodiments, the outer tubular body may further include a compression distal portion that may be held in compression by tension in the loop wire and configured to provide a force in a distal direction to the implantable medical device upon release of the implantable medical device from the distal end of the detachment system.
[0017] In another aspect, a method is disclosed. The method can include providing an outer tubular body including a first lumen extending through an interior along a longitudinal axis. The method can include providing an inner tubular body including a second lumen extending through an interior along a longitudinal axis. The method can include disposing the inner tubular body within the first lumen of the outer tubular body. The method can include forming a radial lumen that can extend radially through the outer tubular body and the inner tubular body orthogonal to the longitudinal axis. A pull wire can extend through the second lumen of the inner tubular body and into the first lumen of the tubular body. A proximal end of the pull wire can be secured to a proximal end of the inner tubular body. An interference feature can extend at least partially through the radial lumen such that the interference feature extends through an outer wall of the outer tubular body and an inner wall of the inner tubular body. The method can include securing an implantable medical device to the outer tubular body such that proximal translation of the pull wire releases the implantable medical device from the outer tubular body. The method can include preventing release of the implantable medical device by an interfering feature while the implantable medical device is delivered through the vasculature to the treatment site. The method can include translating the inner tubular body proximally, thereby fracturing the interfering feature and facilitating release of the implantable medical device from the detachment system.
[0018] In some embodiments, the radial lumens can include an outer radial lumen and an inner radial lumen. The outer radial lumen can be aligned with the inner radial lumen when the implantable medical device is delivered to a target location in a body vessel by the detachment system. The inner radial lumen can be configured to move out of alignment with respect to the outer radial lumen, thereby fracturing the interference feature and facilitating release of the implantable medical device from the detachment system.
[0019] In some embodiments, the method can include attaching a loop wire to the outer tubular body and positioning a loop opening in the loop wire near a distal end of the outer tubular body and through an anchoring portion of the implantable medical device.
[0020] In some embodiments, the interferometric feature can be configured to fracture in response to a force of between about 50 grams force and about 100 grams force.
[0021] In some embodiments, the method can include preventing proximal translation of the inner tubular body relative to the outer tubular body while the implantable medical device is delivered through the vasculature to the treatment site.
[0022] In some embodiments, the method may include securing the interference feature to the outer wall of the outer tubular body using a method selected from welding the interference feature to the outer wall, melting the interference feature to the outer wall, tying the interference feature to the outer wall, and gluing the interference feature to the outer wall.
[0023] In some embodiments, extending the interferometric feature through the radial lumen can include extending a body of the interferometric feature across the entire length of the radial lumen and attaching a first end and a second end of the interferometric feature to an outer wall at each end of the radial lumen.
[0024] In some embodiments, the body of the interfering feature can be a monofilament suture.
[0025] In some embodiments, the pull wire can translate proximally with the inner tubular body as a single unit. [Brief description of the drawings]
[0026] 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 1A] 1 is a diagram of an exemplary detachment system and implant, according to an aspect of the present invention. [Figure 1B] 1 is a diagram of an exemplary detachment system and implant, according to an aspect of the present invention. [Figure 1C] 1 is a diagram of an exemplary detachment system and implant, according to an aspect of the present invention. [Figure 1D] 1 is a diagram of an exemplary detachment system and implant, according to an aspect of the present invention. [Figure 1E] 1 is a diagram of an exemplary detachment system and implant, according to an aspect of the present invention. [Figure 2A] 1A-1C are diagrams of another exemplary detachment system and implant, in accordance with aspects of the present invention. [Figure 2B] 1A-1C are diagrams of another exemplary detachment system and implant, in accordance with aspects of the present invention. [Figure 2C] 1A-1C are diagrams of another exemplary detachment system and implant, in accordance with aspects of the present invention. [Figure 2D] 1A-1C are diagrams of another exemplary detachment system and implant, in accordance with aspects of the present invention. [Figure 2E] 1A-1C are diagrams of another exemplary detachment system and implant, in accordance with aspects of the present invention. [Diagram 3] 1 is an illustration of a delivery system for traversing a body lumen, according to an embodiment of the present invention. [Figure 4] 1 is an illustration of an embolic coil positioned within an aneurysm, according to an aspect of the present invention. [Figure 5A] 1 illustrates a sequence of steps for releasing an embolic implant from a delivery member according to an aspect of the present invention. [Figure 5B]1 illustrates a sequence of steps for releasing an embolic implant from a delivery member according to an aspect of the present invention. [Figure 5C] 1 illustrates a sequence of steps for releasing an embolic implant from a delivery member according to an aspect of the present invention. [Figure 5D] 1 illustrates a sequence of steps for releasing an embolic implant from a delivery member according to an aspect of the present invention. [Figure 6] 4 is a flow chart of an exemplary method of using a desorption system, in accordance with an aspect of the present invention. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0027] The following description of specific examples of the present invention should not be used to limit the scope of the present invention. The drawings, which are not necessarily 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, not by way of limitation. Other examples, features, aspects, embodiments and advantages of the present invention will become apparent to those skilled in the art from the following description, which is by way of example, one of the best modes contemplated for carrying out the present invention. As will be appreciated, the present invention is capable of other different or equivalent aspects, all without departing from the present invention. The drawings and description should therefore be regarded as illustrative in nature, and not restrictive.
[0028] Any one or more of the teachings, expressions, variations, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, variations, examples, etc. described herein. Thus, the teachings, expressions, variations, examples, etc. described below should not be considered in isolation from one another. In light of the teachings herein, various suitable methods that may be combined 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.
[0029] As used herein, the term "about" or "approximately" with respect to any numerical value or range indicates a suitable dimensional tolerance that allows a portion or collection of components to function for the intended purpose described herein. More specifically, "about" or "approximately" may refer to a range of values of ±10% of the recited value, e.g., "about 90%" may refer to a range of values of 81% to 99%. Additionally, as used herein, the terms "patient," "host," "user," and "subject" refer to any human or animal subject, and while use of the invention in human patients represents a preferred embodiment, it is not intended to limit the system or method to human use.
[0030] 1A-1E illustrate an exemplary detachment system 10 for delivering an implantable medical device 12 to a targeted location in a body vessel. More specifically, FIGS. 1A-1E illustrate a sequence of steps for detaching the implantable medical device 12 from the detachment system 10. The exemplary detachment system 10 can include an outer tubular body 90 having a first lumen extending therethrough. The outer tubular body 90 can define a longitudinal axis LL extending along a length of the detachment system 10. An inner tubular body 190 can be disposed within the lumen 708. The inner tubular body 190 can include a second lumen 712 extending therethrough along the longitudinal axis LL. The pull wire 140, disposed at least partially within the second lumen 712 of the inner tubular body 190 and at least partially within the first lumen 708 of the outer tubular body 90, can extend along a longitudinal axis from the proximal end 192 of the inner tubular body 190 to the distal end 94 of the outer tubular body 90. The pull wire can include a proximal end 142 attached to the proximal end 192 of the inner tubular body 190. Thus, when the inner tubular body 190 is translated proximally relative to the outer tubular body 90, the pull wire 140 can translate proximally with the inner tubular body 190 as a single unit. The proximal end 142 of the pull wire 140 can be attached to the proximal end 192 of the inner tubular body 190 in any manner as would be understood by one of ordinary skill in the art. For example, the proximal end 142 of the pull wire 140 may be welded or glued to the proximal end 192 of the inner tubular body 190, although other attachment methods are not excluded. The pull wire 140 may be constructed from any suitable material, for example, the pull wire 140 may be constructed from a shape memory material such as stainless steel or Nitinol. According to some embodiments, the pull wire 140 may be further coated with polytetrafluoroethylene (PTFE).
[0031] The proximal end of each of the loop wires 400 can be attached to the outer tubular body 90 of the detachment system 10. A loop opening 405 can be disposed at the distal end of the loop wire 400. The loop opening 405 can be passed through the locking portion 18 (e.g., an aperture) of the implantable medical device 12. After the loop opening 405 is disposed through the locking portion 18, the distal end 144 of the pull wire 140 can be disposed through the loop opening 405, thereby securing the implantable medical device 12 to the detachment system 10. Just distal to where the proximal end of each of the loop wires 400 is attached to the outer tubular body 90, the outer tubular body 90 can include a compressed distal portion 300. The compressed distal portion 300 can be formed from a spiral cut 306 formed in the outer tubular body 90, which can be formed by a laser cutting operation. Additionally or alternatively, the compressible distal portion 300 may be formed of a winding, a helical ribbon, or other configuration that allows for axial adjustment in accordance with the present invention. Preferably, the compressible distal portion 300 is in an elongated state at rest and will automatically or elastically return from the compressed state to the elongated state unless otherwise restrained. In some embodiments, the implantable medical device 12 may be an embolic coil.
[0032] The radial lumens 150 extending through the outer tubular body 90 and the inner tubular body 190 may be disposed perpendicular to the longitudinal axis LL. For example, the radial lumens may be formed by creating apertures in the outer tubular body walls 96 of the outer tubular body 90 and the inner tubular body 190 such that the radial lumens 150 extend through the respective lumens 708, 712. The radial lumens 150 may include an outer radial lumen 152 and an inner radial lumen 154, which are aligned and collectively form the radial lumen 150 during delivery of the detachment system 10 to a treatment site, as shown in FIG. 1A. The radial lumen 150 may have a length L1 approximately equal to a diameter of the detachment system 10 as measured radially through the outer tubular body 90 (e.g., perpendicular to the longitudinal axis LL). An interference feature 210a may be disposed through the radial lumen 150. As shown in FIGS. 1A-1E, the interferometric feature 210a can include a first end 212, a second end 214, and an interferometric feature 216. The first end 212 of the interferometric feature can be disposed against the outer tubular body wall 96 on a first side of the radial lumen 150. Opposite the first side of the radial lumen 150, the second end 214 of the interferometric feature can be disposed against the outer tubular body wall 96 on a second side of the radial lumen 150. The interferometric feature 216 can extend from the first end 212 through the radial lumen 150 and terminate at the second end 214. The interferometric feature 210a can be constructed from any suitable material, as will be appreciated by one of ordinary skill in the art. According to some embodiments, the interferometric feature 210a can be a polymeric monofilament structure, such as a suture. In some embodiments, the interferometric feature 210a can be constructed from a polymer, such as polypropylene 8-0. The interferometric feature 210a can have advantageous physical properties, such as having a predictable failure load. In some embodiments, the interferometric feature 210a can be attached to the outer wall 96 of the outer tubular body 90 by welding respective ends 212, 214 of the interferometric feature 210a to respective ends of the outer wall 96.In some embodiments, the interferometric feature 210a can be attached to the outer wall 96 by melting the respective ends 212, 214 of the interferometric feature 210a to the respective ends of the outer wall 96. In some embodiments, the interferometric feature 210a can be attached to the outer wall 96 by tying the interferometric feature 210a to the outer wall 96. In yet other embodiments, the interferometric feature 210a can be attached to the outer wall 96 by gluing the respective ends 212, 214 of the interferometric feature 210a to the respective ends of the outer wall 96.
[0033] 1A, the detachment system 10 is shown being delivered to a treatment site through tortuous vasculature. As the detachment system 10 passes through the vasculature, the interference feature 210a prevents proximal translation of the inner tubular body 190 relative to the outer tubular body 90. Thus, the interference feature 150 can be effective to prevent premature detachment of the implantable medical device 12 from the detachment system 10, as it prevents the inner tubular body 190 and the pull wire 140 from translating proximally relative to the outer tubular body 90. FIG. 1B illustrates a cross-sectional view of the detachment system 10 as it is being delivered to a treatment site through tortuous vasculature. As shown, the interference feature 210a can extend through the radial lumen 150 to prevent proximal translation of the inner tubular body 190 relative to the outer tubular body 90. According to some embodiments, the radial lumen 150 can be slightly offset from the central axis of the delivery system 10 to space the interference feature 210a sufficiently away from the pull wire 140 so that the interference feature 210a does not contact or rub against the pull wire 140.
[0034] 1C illustrates the detachment system 10 at a moment when sufficient force in the proximal direction is applied to the inner tubular body 190, thereby causing the interference feature 210a to fracture and facilitating the distal end 144 of the pull wire 140 to be translated proximally. As shown in FIG. 1C, the distal end 144 of the pull wire 140 translates proximally and the distal end 144 of the pull wire 140 exits the loop opening 405, thereby facilitating release of the implantable medical device 12 from the detachment system 10. As seen in FIG. 1C, the outer radial lumen 152 is now misaligned with respect to the inner radial lumen 154. According to some embodiments, the interference feature 210a is configured to fracture in response to a force of approximately 50 to 100 grams force. 1D shows a cross-sectional view of detachment system 10 at a moment when sufficient force in the proximal direction is applied to inner tubular body 190, thereby causing interference feature 210a to fracture and facilitate proximal translation of distal end 144 of pullwire 140. As shown, interference feature 210a may fracture and no longer prevent inner tubular body 190 from translating proximally relative to outer tubular body 90.
[0035] 1E illustrates the detachment system 10 with the detached implantable medical device 12. Following proximal translation of the pullwire 140, the compressed distal portion 300 can elongate to a non-compressed state and exert an elastic force E on the implantable medical device 12, facilitating its complete release from the detachment system 10 and effective deployment to the treatment site.
[0036] 2A-2E are diagrams of another exemplary detachment system and implant according to aspects of the present invention. As shown in FIG. 2A-2E, the detachment system may have an interferometric feature 210b that extends only partially through the radial lumen 150. The interferometric feature 210b may be constructed from any suitable material, as would be understood by one of ordinary skill in the art. According to some embodiments, the interferometric feature 210b may be a polymeric monofilament structure, such as a suture. In some embodiments, the interferometric feature 210b may be constructed from a polymer, such as polypropylene 8-0. The interferometric feature 210b may have advantageous physical properties, such as having a predictable failure load. In some embodiments, the interferometric feature 210b may be attached to the outer wall 96 of the outer tubular body 90 by welding an end 212 of the interferometric feature 210b to the outer wall 96. In some embodiments, the interferometric feature 210b may be attached to the outer wall 96 by melting an end 212 of the interferometric feature 210b to the outer wall 96. In some embodiments, the interferometric feature 210b can be attached to the exterior wall 96 by tying the interferometric feature 210b to the exterior wall 96. In yet other embodiments, the interferometric feature 210b can be attached to the exterior wall 96 by gluing the end 212 of the interferometric feature 210b to the exterior wall 96.
[0037] As shown in Fig. 2A, the interference feature 210b can extend partially through the radial lumen 150 while passing through the outer and inner tubular body walls 96 and 196 on one end of the outer and inner tubular bodies 90 and 190, respectively. Fig. 2B shows a cross-sectional view of the detachment system 10 as it is being delivered to a treatment site through tortuous vasculature. As shown, the interference feature 210b can extend through the outer and inner radial lumens 152 and 154 to prevent proximal translation of the inner tubular body 190 relative to the outer tubular body 90.
[0038] FIG. 2C illustrates the detachment system 10 at a moment when sufficient force is applied to the inner tubular body 190 in a proximal direction, thereby breaking or bending the detachment feature 210b such that the detachment feature 210b no longer interferes with the inner tubular body 190. As seen in FIG. 2C, as the inner tubular body 190 is translated proximally, the inner radial lumen 154 moves out of alignment with the outer radial lumen 152. According to some embodiments, the interference feature 210b is configured to fracture or bend in response to a force of about 50 gf to 100 gf. FIG. 2D illustrates a cross-sectional view of the detachment system 10 at a moment when sufficient force in a proximal direction is applied to the inner tubular body 190, thereby breaking or bending the interference feature 210b and facilitating the distal end 144 of the pull wire 140 to be translated proximally. As shown, the interference feature 210b can be fractured or bent such that the interference feature 210b no longer extends into the inner radial lumen 154 and therefore no longer prevents the inner tubular body 190 from translating proximally relative to the outer tubular body 90.
[0039] 2E illustrates the detachment system 10 with the detached implantable medical device 12. Following proximal translation of the pullwire 140, the compressed distal portion 300 can elongate to a non-compressed state and exert an elastic force E on the implantable medical device 12, facilitating its complete release from the detachment system 10 and effective deployment to the treatment site.
[0040] 3 illustrates the positioning of an implant 12, such as an embolic coil suitable for treating aneurysms, a guide catheter 750, and a delivery system 10, including an outer tubular body 90 and a pull wire 140, within a tortuous vasculature (vasculature not illustrated). At bends A, B, and C, the outer tubular body 90 can extend to a sidewall of the guide catheter 750 on each outer curve of each bend, and similarly, the pull wire 140 can extend to a sidewall of the inner tubular body 190 (not shown) on each outer curve of each bend. Similarly, the inner tubular body 190 can extend to a sidewall of the outer tubular body 90 at bends A, B, and C. During the procedure, the detachment system 10, including the pull wire 140, can be fed in a distal direction D into the guide catheter 750, first passing through bend A, then bend B, then bend C. As the detachment system 10 traverses a bend, the pull wire 140 may be prevented from translating proximally relative to the tubular body 90. The interference features 210a, 210b ensure that the inner tubular body 190 cannot translate proximally relative to the outer tubular body 90 by holding the inner tubular body 190 in alignment with the outer tubular body 90 while the detachment system 10 is traversed through the patient's tortuous vasculature to the treatment site.
[0041] 4 is an illustration of an embolic implant 12 being delivered through a catheter 250 and positioned within an aneurysm A of a blood vessel BV. The implants may loop and bend within the aneurysm sac to form a thrombotic mass. The implants may loop back on themselves and / or loop next to other implants. As the aneurysm A gradually fills, overlapping portions of the implants 12 may be pushed into one another.
[0042] 5A-5D show a timeline of steps for releasing the embolic implant 12 from the delivery system 10. The delivery system 10 may be configured as illustrated in the previous figures and as otherwise described herein. FIG. 5A shows an engagement system including a loop wire 400 and a pull wire 140 that are locked to the locking portion 18 of the medical device 12. The helical cut 306 of the compressible distal portion 300 may be compressed and an opening 405 of the loop wire 400 at a distal end 404 of the loop wire 400 may be positioned through the locking portion 18. Once the pull wire 140 is threaded through the opening 405, the medical device 12 is secured at that point. FIG. 5B shows the pull wire 140 being pulled proximally to initiate the release sequence of the medical device 12. FIG. 5C illustrates the moment when the distal end 144 of the pull wire 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 releases and exits the locking portion 18. As can be seen, there is now nothing holding the medical device 12 to the detachment system 10. Figure 5D 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 305 of the compressible distal portion 300 to the medical device 12, "pushing" it out and ensuring complete detachment and delivery of the medical device 12.
[0043] The compressible portion 306 may have a difference in length (compressed distance) of about 0.5 mm to about 0.75 mm when measured in the compressed configuration and in the original uncompressed configuration. By using a larger compressed distance, a larger elastic force E can be achieved. The compressed 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.
[0044] 6 is a flow chart of an exemplary method of using a detachment system, according to an embodiment of the present invention. In block 604, the method may include providing an outer tubular body 90. The outer tubular body may include a first lumen extending therethrough along a longitudinal axis LL. In optional block 608, the method may include attaching a loop wire to the outer tubular body 90. In optional block 612, the method may include positioning a loop opening 405 in the loop wire 400 near a distal end 94 of the outer tubular body 90. The loop opening 405 may be disposed through an anchoring portion 18 of the implantable medical device 12.
[0045] At block 616, the method may include providing an inner tubular body 190. The inner tubular body may include a second lumen extending therethrough along the longitudinal axis LL. At block 620, the method may include positioning the inner tubular body 190 within the first lumen 708 of the outer tubular body 90. At block 624, the method may include forming a radial lumen 150 extending radially through the outer tubular body 90 and the inner tubular body 190. The radial lumen may be disposed orthogonal to the longitudinal axis LL.
[0046] At block 628, the pull wire can extend through the second lumen 712 of the inner tubular body 190 and into the first lumen 708 of the outer tubular body 90. At block 632, the proximal end 142 of the pull wire 140 can be secured to the proximal end 192 of the inner tubular body 190. As described, the pull wire can be attached to the tubular body 190 using any method known to one of skill in the art, for example, by welding or gluing the proximal end 142 of the pull wire 140 to the proximal end 192 of the inner tubular body 190.
[0047] At block 636, the interference features 210a, 210b can extend at least partially through the radial lumen 150. The interference features can extend through the outer wall 96 of the outer tubular body 90 and the inner wall 196 of the inner tubular body 90.
[0048] In block 640 , the implantable medical device 12 can be secured to the outer tubular body 90 such that proximal translation of the pull wire releases the implantable medical device from the outer tubular body.
[0049] At block 644, the interfering features can prevent release of the implantable medical device 12 while the implantable medical device 12 is delivered through the vasculature to the treatment site. At block 648, the method can include translating the inner tubular body 190 proximally, thereby fracturing the interfering features 210a, 210b and facilitating release of the implantable medical device 12 from the detachment system 10.
[0050] According to some embodiments, the radial lumens can include an outer radial lumen 152 and an inner radial lumen 154. The outer radial lumen 152 can be aligned with the inner radial lumen 154 when the implantable medical device 12 is delivered to a target location in a body vessel by the detachment system 10. The inner radial lumen 154 can be configured to move out of alignment relative to the outer radial lumen 152, thereby fracturing the interference feature 150 and facilitating release of the implantable medical device from the detachment system 10.
[0051] According to some embodiments, the interferometric features 210a, 210b are configured to fracture in response to a force of between about 50 grams force and about 100 grams force.
[0052] According to some embodiments, the method may include preventing proximal translation of the inner tubular body 190 relative to the outer tubular body 90 while the implantable medical device 12 is delivered through the vasculature to the treatment site.
[0053] According to some embodiments, the interference features 210a, 210b are secured to the outer wall 96 of the outer tubular body 90 using a method selected from welding the interference features 210a, 210b to the outer wall 96, melting the interference features 210a, 210b to the outer wall, tying the interference features 210a, 210b to the outer wall 96, and gluing the interference features to the outer wall 96.
[0054] According to some embodiments, extending the interference features 210a, 210b through the radial lumen 150 may further include extending the body 216 of the interference features 210a, 210b across the entire length L1 of the radial lumen 150 and attaching the first end 212 and the second end 214 of the interference features 210a, 210b to the outer wall 96 at their respective ends of the radial lumen 150.
[0055] According to some embodiments, the body 216 of the interference features 210a, 210b may be a monofilament suture. According to some embodiments, the pull wire 140 translates proximally with the inner tubular body 190 as a single unit.
[0056] 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 implantation system and related methods, including alternative geometries of system components, alternative materials, additional or alternative method steps, etc. Modifications that are obvious to one of ordinary skill in the art are intended to be within the scope of the following claims.
[0057] [Embodiment] (1) A detachment system for delivering an implantable medical device to a targeted location in a body vessel, the detachment system comprising: an outer tubular body including a first lumen extending therethrough along a longitudinal axis; an inner tubular body having a second lumen extending therethrough along the longitudinal axis, the inner tubular body being disposed within the first lumen of the outer tubular body; a pull wire disposed at least partially within the second lumen of the inner tubular body and at least partially within the first lumen of the outer tubular body, the pull wire configured to translate proximally relative to the outer tubular body to release the implantable medical device from the distal end of the detachment system; a radial lumen extending through the outer tubular body and the inner tubular body perpendicular to the longitudinal axis; an interference feature extending at least partially through the radial lumen; the interference feature is effective to prevent premature detachment of the implantable medical device when the implantable medical device is delivered to the target location in the body vessel by the detachment system; The detachment system, wherein the interference feature is configured to fracture in response to proximal translation of the inner tubular body, thereby facilitating release of the implantable medical device from the detachment system. (2) The detachment system of claim 1, wherein the interference feature comprises a monofilament suture. (3) The desorption system of claim 2, wherein the interference feature is constructed from polypropylene 8-0. (4) The detachment system of embodiment 1, wherein the interference feature is secured to the outer wall by a method selected from welding the interference feature to the outer wall of the outer tubular body, melting the interference feature to the outer wall, tying the interference feature to the outer wall, and gluing the interference feature to the outer wall. (5) The detachment system of embodiment 1, wherein the interference feature prevents proximal translation of the inner tubular body relative to the outer tubular body.
[0058] (6) The detachment system of embodiment 1, wherein the proximal end of the pull wire is attached to the proximal end of the inner tubular body, and the pull wire is configured to translate with the inner tubular body as a single unit relative to the outer tubular body. (7) the radial lumen comprises an outer radial lumen and an inner radial lumen; the outer radial lumen is aligned with the inner radial lumen when the implantable medical device is delivered to the target location in the body vessel by the detachment system; The detachment system of embodiment 1, wherein the inner radial lumen is configured to move out of alignment relative to the outer radial lumen, thereby fracturing the interference feature and facilitating release of the implantable medical device from the detachment system. (8) The detachment system of embodiment 1, wherein the interference feature extends through the entire length of the radial lumen, and the interference feature is secured to the outer wall of the outer tubular body at each end of the radial lumen. (9) The detachment system of claim 1, wherein the interference feature is configured to fracture in response to a force of about 0.49 N to about 0.98 N (about 50 g force to about 100 g force). (10) further comprising a loop wire having a loop opening disposed near the distal end of the outer tubular body; 2. The detachment system of claim 1, wherein the loop wire and the pull wire are arranged to secure the implantable medical device to the detachment system.
[0059] (11) The detachment system of embodiment 10, wherein the outer tubular body further comprises a compression distal portion held in compression by tension in the loop wire and configured to provide a force in a distal direction to the implantable medical device upon release of the implantable medical device from the distal end of the detachment system. (12) A method comprising the steps of: providing an outer tubular body of a detachment system, the outer tubular body including a first lumen extending therethrough along a longitudinal axis; providing an inner tubular body of the detachment system, the inner tubular body including a second lumen extending therethrough along the longitudinal axis; disposing the inner tubular body within the first lumen of the outer tubular body; forming a radial lumen extending radially through the outer tubular body and the inner tubular body perpendicular to the longitudinal axis; extending a pull wire through the second lumen of the inner tubular body and into the first lumen of the outer tubular body; securing a proximal end of the pull wire to a proximal end of the inner tubular body; extending an interference feature at least partially through the radial lumen such that the interference feature extends through an outer wall of the outer tubular body and an inner wall of the inner tubular body; securing the implantable medical device to the outer tubular body such that proximal translation of the pull wire releases the implantable medical device from the outer tubular body; preventing release of the implantable medical device by the interference feature while the implantable medical device is delivered through a vasculature to a treatment site; and translating the inner tubular body proximally, thereby fracturing the interference feature and facilitating the release of the implantable medical device from the detachment system; A method comprising: (13) The radial lumen comprises an outer radial lumen and an inner radial lumen; The method of embodiment 12, wherein the outer radial lumen is aligned with the inner radial lumen when the implantable medical device is delivered to a target location in a body vessel by the detachment system, and the inner radial lumen is configured to move out of alignment relative to the outer radial lumen, thereby fracturing the interference feature and facilitating release of the implantable medical device from the detachment system. (14) attaching a loop wire to the outer tubular body; 13. The method of claim 12, further comprising positioning a loop opening in the loop wire near a distal end of the outer tubular body and through an anchoring portion of the implantable medical device. 15. The method of claim 13, wherein the interferometric feature is configured to fracture in response to a force of about 0.49 N to about 0.98 N (about 50 g force to about 100 g force).
[0060] (16) The method of embodiment 12, further comprising preventing proximal translation of the inner tubular body relative to the outer tubular body while the implantable medical device is delivered through a vasculature to the treatment site. (17) The method of claim 12, further comprising fixing the interference feature to the outer wall of the outer tubular body using a method selected from welding the interference feature to the outer wall, melting the interference feature to the outer wall, tying the interference feature to the outer wall, and gluing the interference feature to the outer wall. (18) Extending the interference feature through the radial lumen comprises: extending a body of the interference feature across an entire length of the radial lumen; 13. The method of claim 12, further comprising attaching a first end and a second end of the interference feature to the outer wall at respective ends of the radial lumen. (19) The method of claim 18, wherein the body of the interference feature comprises a monofilament suture. (20) The method of embodiment 13, wherein the pull wire translates proximally with the inner tubular body as a single unit.
Claims
1. 1. A detachment system for delivering an implantable medical device to a targeted location in a body vessel, the detachment system comprising: an outer tubular body including a first lumen extending therethrough along a longitudinal axis; an inner tubular body including a second lumen extending therethrough along the longitudinal axis, the inner tubular body being disposed within the first lumen of the outer tubular body; a pull wire disposed at least partially within the second lumen of the inner tubular body and at least partially within the first lumen of the outer tubular body, the pull wire configured to translate proximally relative to the outer tubular body to release the implantable medical device from the distal end of the detachment system; a radial lumen extending through the outer tubular body and the inner tubular body perpendicular to the longitudinal axis; an interference feature extending at least partially through the radial lumen; the interference feature is effective to prevent premature detachment of the implantable medical device when the implantable medical device is delivered to the target location in the body vessel by the detachment system; The detachment system, wherein the interference feature is configured to fracture in response to proximal translation of the inner tubular body, thereby facilitating release of the implantable medical device from the detachment system.
2. The detachment system of claim 1 , wherein the interference feature comprises a monofilament suture.
3. The desorption system of claim 2 , wherein the interference feature is constructed from polypropylene 8-0.
4. 2. The detachment system of claim 1, wherein the interference feature is secured to the outer wall by a method selected from welding the interference feature to the outer wall of the outer tubular body, melting the interference feature to the outer wall, tying the interference feature to the outer wall, and gluing the interference feature to the outer wall.
5. The detachment system of claim 1 , wherein the interference feature prevents proximal translation of the inner tubular body relative to the outer tubular body.
6. 2. The detachment system of claim 1, wherein a proximal end of the pull wire is attached to a proximal end of the inner tubular body, the pull wire being configured to translate with the inner tubular body as a single unit relative to the outer tubular body.
7. the radial lumen comprises an outer radial lumen and an inner radial lumen; the outer radial lumen is aligned with the inner radial lumen when the implantable medical device is delivered to the target location in the body vessel by the detachment system; 10. The detachment system of claim 1, wherein the inner radial lumen is configured to move out of alignment relative to the outer radial lumen, thereby fracturing the interference feature and facilitating release of the implantable medical device from the detachment system.
8. 2. The detachment system of claim 1, wherein the interference feature extends through an entire length of the radial lumen, the interference feature being secured to an outer wall of the outer tubular body at each end of the radial lumen.
9. The desorption system of claim 1 , wherein the interference feature is configured to fracture in response to a force of about 0.49 N to about 0.98 N (about 50 g force to about 100 g force).
10. a loop wire having a loop opening disposed near the distal end of the outer tubular body; The detachment system of claim 1 , wherein the loop wire and the pull wire are positioned to secure the implantable medical device to the detachment system.
11. 11. The detachment system of claim 10, wherein the outer tubular body further comprises a compression distal portion held in compression by tension in the loop wire and configured to provide a force in a distal direction to the implantable medical device upon release of the implantable medical device from the distal end of the detachment system.