Patent Application
20230414222
The present invention relate to aneurysm treatment devices and more particularly, to a delivery system for deploying an implantable medical device to a target location of a body vessel that includes a detachment indicator indicating when the implantable medical device has been deployed.
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. A physician desires feedback that a detachment cycle has been completed correctly. In most mechanical delivery systems, an inner tube is held within a lumen of a delivery system pusher and is attached to an internal wire that travels the length of the device. When pulled, the internal wire translates backwards to detach the implant. In traditional systems, an identifier that the detachment cycle has been completed is that the inner tube has been translated and thus increases in length. However, in traditional deployment systems, it is difficult for the physician to visually determine whether the implant has been deployed successfully because the small change in length is difficult to determine visually.
Accordingly, there is a need for a deployment system that has a detachment indicator indicating to the physician that the implant has been successfully deployed.
Disclosed herein are various exemplary systems, devices, and methods of the present disclosure that can address the above needs. Examples can generally include a delivery system for deploying an implantable medical device to a target location of a body vessel. The delivery system can include a tubular body that includes a lumen extending therethrough. The delivery system can include a pull wire that extends through the lumen. The delivery system can include a proximal support tube that is disposed within the lumen. The proximal support tube can include a marked distal section that is 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 can be configured to engage a proximal end of the pull wire such that proximal translation of the proximal support tube causes the pull wire to be translated proximally thereby releasing an implantable medical device from a distal end of the tubular body. The proximal support tube can be configured such that proximal translation of the proximal support tube resulting in release of the implantable medical device moves the marked distal section from the lumen of the tubular body so that the marked distal section is visible.
The delivery system can further include a loop wire that includes a loop opening at a distal portion of the loop wire positioned approximate 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.
The implantable medical device can be deployed in response to proximal translation of the proximal support tube, which can cause a distal end of the pull wire to exit the loop opening, which can cause the loop wire and the pull wire to disengage the medical device from the delivery system.
The marked distal section can include a laser etching visible to the operator of the delivery system upon deployment of the implantable medical device.
The marked distal section can include an anodized portion of the proximal support tube visible to an operator of the delivery system upon deployment of the implantable medical device.
The marked distal section can include a printed or dipped portion of the proximal support tube visible to an operator of the delivery system upon deployment of the implantable medical device.
The marked distal section can be visibly distinguishable from a remainder of the proximal support tube.
A remainder of the proximal support tube can include a first color, and the marked distal section can include a second color distinguishable from the first color.
Proximal translation of the proximal support tube can be between approximately 6 millimeters and approximately 12 millimeters to expose the marked distal portion.
Proximal translation of the proximal support tube can be between approximately 6 millimeters and approximately 12 millimeters to deploy the implantable medical device.
The tubular body can include a proximal tube, a flexible tube distal to the proximal tube, and a distal tube distal to the flexible tube.
The flexible tube can include interference cuts.
The distal tube can further include a compressed distal portion positioned approximate the implantable medical device. The compressed portion can provide an elastic force against the implantable medical device to thereby facilitate the release of the implantable medical device from the delivery system.
The compressed distal portion can include a spiral cut portion of the distal tube.
In another aspect, a method for using a delivery system to deploy an implantable medical device to a target location of a body vessel is disclosed. The method can include providing a tubular body. The tubular body can include a lumen extending therethrough. The method can include extending a pull wire through the lumen. The method can include providing a proximal support tube that is disposed within the lumen. The proximal support tube can include a marked distal section that is covered by the tubular body such that the marked distal section is not visible to an operator of the delivery system. The method can include engaging a proximal end of the pull wire to the proximal support tube such that proximal translation of the proximal support tube causes the pull wire to be translated proximally. The method can include securing the implantable medical device to the tubular body with the pull wire. The method can include delivering the implantable medical device to the target location of the body vessel while the marked distal section remains covered by the tubular body. The method can include translating a proximal support tube proximally to release the implantable medical device from a distal end of the tubular body, thereby moving the marked distal section proximally out of the lumen so that the marked distal section is visible.
The marked distal section can include a laser etching visible to an operator of the delivery system upon deployment of the implantable medical device.
The marked distal section can include an anodized portion of the proximal support tube visible to an operator of the delivery system upon deployment of the implantable medical device.
The marked distal section can include a printed or dipped portion of the proximal support tube visible to an operator of the delivery system upon deployment of the implantable medical device.
A remainder of the proximal support tube can include a first color and the marked distal section can include a second color distinguishable from the first color.
Proximal translation of the proximal support tube of between approximately 6 millimeters and approximately 12 millimeters exposes the marked distal portion and is effective to deploy the implantable medical device.
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,
The flexible tube 550 can include a coiled wire, support coil that is attached at each end to the proximal tube 110 and the distal tube 570 respectively. Alternatively, the flexible tube 550 can include a laser cut hypotube including interference cuts 560 as illustrated in
An 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 flexible tube 550. Inner support tube 510 can provide structural support to the flexible tube 550. In some examples, the inner support tube 510 can prevent the flexible but 550 from elongating. The inner support tube 510 is optional if the interference cuts are made to allow the flexible tube 550 to have sufficient structural support in the absence of the support tube 510, or if other features are included to provide structural support to the flexible tube 550.
A pull wire 140 can extend through the lumen 608 of delivery system 10. Within lumen 608 of proximal tube 100 can be positioned a proximal support tube 110. Proximal support tube 110 can be welded or otherwise attached to the inner sidewall of proximal tube 100. Both proximal support tube 110 and inner support tube 510 can be considered as part of tubular body 90. Proximal support tube 110 can be considered to be located on proximal end 92 of the tubular body 90. The pull wire 140 can include a pull wire bead 142 located on a proximal end of pull wire 140. The pull wire bead 142 can be sized such that the pull wire bead 142 is larger than the space between the proximal support tube 110 such that the pull wire bead 142 interferes with the proximal support tube 110 and proximal support tube 110 retains the pull wire bead 142 proximal to the proximal tube 100. Alternatively, the proximal end of the pull wire can be welded to the proximal tube 110 or otherwise engaged to the proximal tube 110 as understood by a person skilled in the pertinent art.
A loop wire opening 405 of loop wire 400 (also illustrated with respect to
The proximal support tube 110 can include a marked distal section 114 that is located within the proximal tube 100. The marked distal section 114 can be configured to be hidden from view of an operator of the delivery system 10 while implant 12 is delivered to a target location within a patient. When the pull wire 140 is pulled proximally a distance sufficient to detach implant 12, the proximal support tube 110 can be configured to translate proximally, thereby causing the marked distal section 114 to exit the proximal tube 100 and become visible to an operator of the delivery system 10.
When the delivery system 10 is assembled, the flexible tube 550 and 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 bend test wherein a portion of the delivery system 10 is held fixed at two end points, a force is applied perpendicularly to the delivery system 10 centrally between the points, and flexibility is quantified by the length of deflection of the delivery system 10 caused by the force. When measured in this way, in some examples, the flexible tube 550 and sleeve 500 can be about 1.5 times more flexible than the distal tube 570 and about 20 times more flexible than the proximal tube 100. That is, when the three-point test is performed identically on the three sections 100, 550, and 570, the flexible tube 550 can deflect over a length that is about 1.5 times the deflection of the distal tube 570 and about 20 times the length of deflection of the proximal tube 100. Flexibility can be measured in other ways as would be appreciated and understood by a person having pertinent skill in the art.
According to some embodiments, the distal tube 570 can include a compressible distal portion 300 (as shown in greater detail in
Pull wire 140 can be constructed out of any suitable material, for example, pull wire 140 can be constructed of stainless steel or memory shape material, such as nitinol. According to some embodiments, pull wire 140 can additionally be coated with polytetrafluoroethylene (PTFE).
The handle channel 56, found on the bottom of handle member 50a, can be configured to engage with proximal support tube 110 and can have a length sufficient to engage to the length of proximal support tube 110. Aperture 54 has a diameter sufficient to fit proximal support tube 110 therethrough. Proximal support tube 110 is configured to pass through aperture 54 when engaging to handle member 50 at handle channel 56.
Handle button 52 can be configured to be pressed by an operator of the delivery system 10. When handle button 52 is pressed (e.g., towards a bottom surface of handle member 50), the proximal support tube 110 can be pressed against the top surface of handle channel 56, which can cause the support tube 110 and pull wire 140 to be retracted, 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.
Alternatively, the handle 50 may include a shuttle system to move the proximal support tube 110 a greater distance than the distance through which the handle button 52 travels.
The compressible distal portion 306 can have a difference in length (distance of compression) when measured in the compressed configuration and the original, uncompressed configuration of about 0.5 mm to about 0.75 mm. Greater elastic force E can be achieved by using a greater distance of compression. The distance of compression can be determined by the sizing 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.
In block 916, the method can include engaging a proximal end 142 of the pull wire 140 to the proximal support tube 110. Proximal translation of the proximal support tube 110 can cause the pull 140 to be translated proximally. In block 920, the method can include securing the implantable medical device 12 to the tubular body 90 with the pull wire 140.
In block 924, the method can include delivering the implantable medical device 12 to the target location of the body vessel. While delivering the implantable medical device, the marked distal section n114 can remain covered by the tubular body 90 such that it is not visible to the operator of the delivery system.
In block 928, the method can include translating the proximal support tube 110 proximally to release the implantable medical device 12 from a distal end 94 of the tubular body 90. The marked distal section 114 can be moved proximally out of the lumen 608 such that the marked distal section 114 becomes visible to an operator of the delivery system. The marked distal section can thereby effectively indicate that the implantable medical device 12 has been successfully deployed at the target location of the body vessel.
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.
