The present invention relate to aneurysm treatment devices and more particularly, to improved delivery systems for embolic implants.
Numerous intravascular implant devices are known in the field. Many are deployed mechanically, via systems that combine 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 may also be implanted via similar systems that combine one or more catheters and wires. Devices that may be released or deployed by mechanical means vary greatly in design but can employ a similar delivery catheter and wire system. Many such catheter-based delivery systems include a wire for retention of the implant in the catheter until the time for release of the device. These systems are then actuated by retracting or pulling the wire relative to the catheter. Such a wire is referred to herein as a “pull wire”. Many such catheter-based delivery systems also implement a “loop wire” having ends attached to the tubular body of the catheter and forming a loop through which the pull wire may be positioned in order to retain the implant in the catheter.
One issue with current catheter-based delivery systems is the complexity of attaching the loop wire to the tubular body of the catheter. The complexity of forming the loop wire and attaching the loop wire to the catheter delivery system lowers the reliability of the delivery system and increases the probability that the implant is prematurely detached from the catheter system.
Accordingly, there is a need for an improved implant delivery system that does not utilize a loop wire to retain the implant to the catheter system. This disclosure is directed to this and other considerations.
Various systems and methods of deploying an implantable medical device to a target location of a body vessel are disclosed. A delivery system can include a tubular body defining a longitudinal axis. The tubular body can include a lumen extending therethrough, a sidewall surrounding the lumen, and a feature formed from the sidewall. The feature can include an aperture. A pull wire can be extended through the lumen. The delivery system can include an implantable medical device that includes a locking portion. The locking portion can include an opening. The feature can be positioned within the opening of the locking portion. A distal end of the pull wire can pass through the aperture of the feature to secure the implantable medical device to the delivery system.
In one aspect, a delivery system for deploying an implantable medical device to a target location of a body vessel is disclosed. The delivery system can include a tubular body that defines a longitudinal axis. The tubular body can include a lumen extending therethrough, a sidewall that surrounds the lumen, and a feature formed from the sidewall. The feature can include an aperture therethrough. The system can include a pull wire that extends through the lumen. The delivery system can include an implantable medical device, and the implantable medical device can include a locking portion that has an opening. The feature formed from the sidewall can be positioned within the opening of the locking portion of the implantable medical device. A distal end of the pull wire can pass through the aperture of the feature to secure the implantable medical device to the delivery system.
In some embodiments, the feature can include a tab shape that is cut into the sidewall and bent into a folded configuration. The feature can be deflected towards the longitudinal axis of the tubular body to secure the implantable medical device to the delivery system. In some embodiments, the feature can be laser cut from the sidewall.
In some embodiments, the feature can be configured to return to a non-folded configuration when the distal end of the pull wire is removed from the aperture, thereby deploying the implantable medical device to the target location of the body vessel.
In some embodiments, the feature is configured to impart an elastic force to the implantable medical device in response to the feature returning to the non-folded configuration from the folded-configuration.
In some embodiments, the feature can be formed of a memory-shape material.
In some embodiments, the pull wire can be coated with polytetrafluoroethylene (PTFE).
In some embodiments, the feature can be constructed of an elastic material.
In some embodiments, the distal end of the pull wire can be positioned through the aperture of the feature such that the distal end of the pull wire interferes with the locking portion which can secure the implantable medical device to the delivery system.
In some embodiments, when the pull wire is pulled proximally, the distal end of the pull wire is withdrawn from the aperture of the feature to release the implantable medical device from the delivery system.
In some embodiments, when the distal end of the pull wire is withdrawn from the aperture of the feature, the distal end of the pull wire no longer interferes with the locking portion, thereby facilitating release of the implantable medical device from the delivery system.
In another aspect, a method is disclosed. The method can include providing a tubular body that includes a lumen extending therethrough and a sidewall surrounding the lumen. The tubular body can define a longitudinal axis. The method can include forming a feature in the sidewall of the tubular body. The feature can include an aperture. The feature can be bent into a folded configuration from a non-folded configuration such that the feature is deflected towards a longitudinal axis of the tubular body. A pull wire can be extended through the lumen. A locking portion of an implantable medical device can be positioned over the feature in the folded configuration. A distal end of the pull wire can be positioned through the aperture of the feature to thereby secure the implantable medical device to the tubular body. The implantable medical device can be positioned approximate a target location of a body vessel. The pull wire can be translated proximally to thereby deploy the implantable medical device to the target location of the body vessel.
In some embodiments, the feature can include a tab shape cut into the sidewall and bent into a folded configuration. In some embodiments, forming the feature can include laser cutting the feature in the sidewall.
In some embodiments, deploying the implantable medical device to the target location of the body vessel can further include the feature returning to the non-folded configuration from the folded-configuration.
In some embodiments, the returning of the feature to the non-folded configuration can impart an elastic force to the implantable medical device as it is deployed to the target location of the body vessel.
In some embodiments, the method can include coating the pull wire with polytetrafluoroethylene (PTFE).
In some embodiments, when the pull wire is pulled proximally the distal end of the pull wire is withdrawn from the aperture of the feature to release the implantable medical device from the tubular body.
In some embodiments, when the distal end of the pull wire is withdrawn from the aperture of the feature, the distal end of the pull wire no longer interferes with the locking portion of the implantable medical device, thereby facilitating the release of the implantable medical device from the tubular body.
In some embodiments, the feature can be formed of a memory shape material.
The above and further aspects of this invention are 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 various figures. The drawings are not necessarily to scale, emphasis instead being placed upon illustrating principles of the invention. The figures depict one or more implementations of the inventive devices, by way of example only, not by way of limitation.
The following description of certain examples of the 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 invention. The detailed description illustrates by way of example, not by way of limitation, the principles of the invention. Other examples, features, aspects, embodiments, and advantages of the invention will become apparent to those skilled in the pertinent art from the following description, which is by way of illustration, one of the best modes contemplated for carrying out the invention. As will be realized, the invention is capable of other different or equivalent aspects, all without departing from the invention. Accordingly, the drawings and descriptions should be regarded as illustrative in nature and not restrictive.
Any one or more of the teachings, expressions, versions, examples, etc. described herein may be combined with any one or more of the other teachings, expressions, versions, examples, etc. that are described herein. The following-described teachings, expressions, versions, examples, etc. should therefore not be viewed in isolation relative to each other. Various suitable ways in which the teachings herein may be combined will be readily apparent to those skilled in the pertinent art in view of the teachings herein. Such modifications and variations are intended to be included within the scope of the claims.
As used herein, the terms “about” or “approximately” for any numerical values or ranges indicate a suitable dimensional tolerance that allows the part or collection of components to function for its intended purpose as described herein. More specifically, “about” or “approximately” may refer to the range of values±10% of the recited value, e.g. “about 90%” may refer to the range of values from 81% to 99%. In addition, as used herein, the terms “patient,” “host,” “user,” and “subject” refer to any human or animal subject and are not intended to limit the systems or methods to human use, although use of the subject invention in a human patient represents a preferred embodiment.
Turning to the figures,
In block 608, the method can include forming a feature 150 in the sidewall 96 of the tubular body. The feature can include an aperture 152. In block 612, the method can include bending the feature 150 into a folded configuration 156 from a non-folded configuration 154. Once bent, the feature 150 can be deflected towards the longitudinal axis L-L of the tubular body 90.
In block 616, a pull wire 140 can be extended through the lumen 508. In block 620, the method can include positioning a locking portion 18 of an implantable medical device 12 over the feature 150 while the feature 150 is in the folded configuration 156. In block 624, the method can include positioning a distal end 144 of the pull wire 140 through the aperture 152 of the feature 150. Once the distal end 144 of the pull wire 140 is positioned through the aperture 152, the implantable medical device can be secured to the tubular body 90 of the delivery system 10.
In block 628, the method can include positioning the implantable medical device 12 approximate a target location of a body vessel. In block 632, the method can include translating the pull wire 140 proximally to thereby deploy the implantable medical device 12 to the target location of the body vessel.
In some embodiments, the feature can be formed as a tab shape cut into the sidewall 96 and bent into a folded configuration 156.
In some embodiments, forming the feature can further include laser cutting the feature 150 in the sidewall 96.
In some embodiments, deploying the implantable medical device 12 to the target location of the body vessel can further include the feature returning to the non-folded configuration 154 from the folded configuration 156.
In some embodiments, the return of the feature 150 to the non-folded configuration 154 can impart an elastic force (E) to the implantable medical device 12 as it is deployed to the target location of the body vessel.
In some embodiments, the method can include coating the pull wire 140 with PTFE.
In some embodiments, when the pull wire 140 is pulled proximally, the distal end 144 of the pull wire 140 is withdrawn from the aperture 152 of the feature to release the implantable medical device from the tubular body 90.
In some embodiments, when the distal end 144 of the pull wire 140 is withdrawn from the aperture 152 of the feature 150, the distal end 144 of the pull wire 140 no longer interferes with the locking portion 18 to thereby facilitate release of the implantable medical device from the tubular body 90. In some embodiments, the feature 150 can be formed of a memory shape material.
The descriptions contained herein are examples of embodiments of the invention and are not intended in any way to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of the implantation system and associated methods, including alternative geometries of system components, alternative materials, additional or alternative method steps, etc. Modifications apparent to those skilled in the pertinent art are intended to be within the scope of the claims which follow.