Systems and methods for inhibiting premature embolic implant deployment

Information

  • Patent Grant
  • 12011171
  • Patent Number
    12,011,171
  • Date Filed
    Thursday, January 6, 2022
    2 years ago
  • Date Issued
    Tuesday, June 18, 2024
    5 months ago
Abstract
Disclosed herein are various exemplary systems, devices, and methods for inhibiting premature implant deployment. The delivery member can include a body including a lumen extending therethrough, the body including a compressed distal portion. The delivery member can include a pull wire extending through the lumen. The pull wire can include a pull wire portion that extends radially to abut a sidewall of the body to provide frictional resistance against the body. The pull wire can be positioned to secure the implantable medical device to the delivery member, and the pull wire portion can be effective to inhibit premature detachment of the implant by inhibiting proximal translation of the pull wire due to the frictional resistance provided by the pull wire portion against the body.
Description
FIELD OF INVENTION

The present invention relate to aneurysm treatment devices and more particularly, to improved delivery systems for embolic implants that prevent premature implant deployment.


BACKGROUND

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”.


One issue with current catheter-based delivery systems is premature detachment of the implantable device. Premature detachment occurs when the implant is detached from the delivery system before reaching the treatment site. This may occur due to the tortuosity experienced by the delivery system as it passes through the vasculature of the patient, which can cause an increase in friction between the “pull wire” and the delivery system causing the pull wire to move proximally while the delivery system is moving distally.


Accordingly, there is a need for an improved implant delivery system that prevents premature detachment of the implant as it is delivered through tortuous vasculature. This disclosure is directed to this and other considerations.


SUMMARY

Disclosed herein are various exemplary systems, devices, and methods for inhibiting premature implant deployment. The delivery member can include a body including a lumen extending therethrough, the body including a compressed distal portion. The delivery member can include a pull wire extending through the lumen. The pull wire can include a pull wire portion that extends radially to abut a sidewall of the body to provide frictional resistance against the body. The pull wire can be positioned to secure the implantable medical device to the delivery member, and the pull wire portion can be effective to inhibit premature detachment of the implant by inhibiting proximal translation of the pull wire due to the frictional resistance provided by the pull wire portion against the body.


In one aspect, a delivery member for delivering an implantable medical device to a target location of a body vessel is disclosed. The delivery member can include a body that includes a lumen extending therethrough and a compressed distal portion. The delivery member can include a pull wire that extends through the lumen. The pull wire can include a pull wire portion that extends radially to abut a sidewall of a support coil inner tube to provide frictional resistance. The pull wire can be positioned to secure the implantable medical device to the delivery member. The pull wire portion can be effective to inhibit premature detachment of the implantable medical device by inhibiting proximal translation of the pull wire due to the frictional resistance provided by the pull wire portion against the sidewall.


In some embodiments, the pull wire is movable to release the implantable medical device from the delivery member. In some embodiments, the pull wire portion includes a shaped feature selected from a trapezoidal-shaped feature, a triangular-shaped feature, a corkscrew-shaped feature, a knot-shaped feature, or a wave-shaped feature.


In some embodiments, the pull wire is made of stainless steel. In some embodiments, the pull wire is made of a memory shape alloy. In some embodiments, the pull wire is coated with a polytetrafluoroethylene (PTFE) coating. In some embodiments, the PTFE coating is selectively removed from the pull wire portion.


In some embodiments, the pull wire portion remains in contact with the sidewall of the body as the implantable medical device is delivered to the target location of the body vessel.


In some embodiments, the delivery member can include a loop wire that includes a first end that is affixed to the body and a loop opening that is positioned approximate a distal end of the compressed distal portion.


In some embodiments, the loop wire is stretch resistant, and the loop wire is under tension when the implantable medical device is secured to the delivery member. In some embodiments, the body further includes a flexible coil that is disposed in a proximal direction from the distal portion. The loop wire can inhibit elongation of the compressed distal portion.


In some embodiments, the delivery member can include a sleeve that extends along a majority of the flexible coil.


In another aspect, a method is disclosed. The method can include providing a body that includes a lumen extending therethrough and a compressible distal portion. The method can include compressing the compressible distal portion. The method can include extending a pull wire through the lumen. The method can include securing a distal end of the pull wire to an implantable medical device. The method can include forming a pull wire portion of the pull wire to abut a sidewall of a support coil inner tube to provide a frictional resistance against the sidewall.


In some embodiments, the method can include inhibiting, through the frictional resistance of the pull wire portion against the sidewall, release of the implantable medical device while the implantable medical device is delivered through the vasculature to a treatment site and providing a force sufficient to overcome the frictional resistance of the pull wire portion against the sidewall, thereby translating the pull wire proximally and releasing the implantable medical device at the treatment site.


In some embodiments, the method can include affixing a loop wire to the body, positioning a loop opening in the loop wire approximate a distal end of the compressible distal portion while the loop wire is affixed to the body such that the loop wire is extended through the lumen, and extending the loop opening through a locking portion of an implantable medical device.


In some embodiments, the pull wire portion can include a shaped feature selected from a trapezoidal-shaped feature, a triangular-shaped feature, a corkscrew-shaped feature, a knot-shaped feature, or a wave-shaped feature.


In some embodiments, the pull wire can include a memory shape alloy.


In some embodiments, inhibiting release of the implantable medical device can include the pull wire portion remaining in contact with the sidewall as the implantable medical device is delivered to the target location of the body vessel.


In some embodiments, the method can include coating the pull wire with a polytetrafluoroethylene (PTFE) coating and selectively removing the PTFE coating from the pull wire portion.


In some embodiments, the method can include connecting a distal end of a proximal hypotube to a flexible coil, connecting a distal end of the flexible coil to a proximal end of the compressible distal portion of the body, connecting the proximal tube, flexible coil, and compressible distal hypotube to provide the body which includes a lumen extending through the proximal tube, flexible coil, and the compressed distal portion, and positioning a sleeve to extend along a majority of the flexible coil, thereby inhibiting radial expansion of the flexible coil.





BRIEF DESCRIPTION OF THE DRAWINGS

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.



FIG. 1 an illustration of a delivery member and implant, according to aspects of the present invention.



FIG. 2 is an illustration of another delivery member and implant, according to aspects of the present invention.



FIGS. 3A-3E are illustrations of exemplary pull wire portions, according to aspects of the present invention.



FIG. 4 is an illustration of embolic coils being positioned within an aneurysm according to aspects of the present invention.



FIG. 5 is an illustration of a delivery member navigating a body lumen according to aspects of the present invention.



FIGS. 6A-6D illustrate a sequence of steps for releasing an embolic implant from the delivery member, according to aspects of the present invention.



FIG. 7 is a flowchart of an example method of using the delivery member, according to aspects of the present invention.



FIG. 8 is an illustration of an exemplary pull wire portion, according to aspects of the present invention.





DETAILED DESCRIPTION

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, as illustrated in FIGS. 1 and 2 an example delivery member 10a, 10b, can include a proximal tube 100, a coiled section 200, a compressible distal portion 300, a sleeve 500 surrounding the coiled section, and a loop wire 400 extending through the compressed distal portion 300. The delivery member 10a, 10b can have a lumen 608 therethrough extending through the proximal tube 100, coiled section 200, and compressible distal portion 300. That is, the proximal tube 100 can have a lumen 108 therethrough, the coiled section 200 can have a lumen 208 therethrough, the compressible distal portion 300 can have a lumen 308 therethrough, and the lumens 108, 208, 308 can be contiguous to form the lumen 608 through the delivery member 10a, 10b. The proximal tube 100 can have a distal end 104 connected to a proximal end 202 of the coiled section 200 and a distal end 204 of the coiled section 200 can be connected to a proximal end 302 of the compressible distal portion 300. Proximal tube 100, coiled section 200, and compressed distal portion 300 can be collectively referred to as body 90.


The compressible distal portion 300 can be formed from a spiral cuts 306 made within the compressible distal portion 300. The compressible portion 300 can be axially adjustable between an elongated condition and a compressed condition. The compressible portion 300 can be formed from a spiral-cut portion of the tube 300, formed by a laser cutting operation. Additionally, or alternatively, the compressible portion can be formed of a wound wire, spiral ribbon, or other arrangement allowing axial adjustment according to the present invention. Preferably, compressible portion 300 is in the elongated condition at rest and automatically or resiliently returns to the elongated condition from a compressed condition, unless otherwise constrained.


When the delivery member 10a, 10b, is assembled, the coiled section 200 and sleeve 500 can be more flexible than the compressed distal portion 300 and the proximal tube 100. One way to measure flexibility is to perform a three-point bend test wherein a portion of the delivery member 10a, 10b is held fixed at two end points, a force is applied perpendicularly to the member 10a, 10b centrally between the points, and flexibility is quantified by the length of deflection of the delivery member 10a, 10b caused by the force. When measured in this way, in some examples, the coiled section 200 and sleeve can be about 1.5 times more flexible than the compressed distal portion 300 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, 200, and 300, the coiled section deflect over a length that is about 1.5 times the deflection of the distal hypotube and about 20 times the length of deflection of the proximal hypotube. Flexibility can be measured in other ways as would be appreciated and understood by a person having pertinent skill in the requisite art. When the delivery member 10a, 10b is assembled, the coiled section 200 and sleeve 500 can be more flexible than the distal hypotube and the proximal hypotube as flexibility is determined by other means as would be known to a person having pertinent skill in the relevant art.


The coiled section can be formed primarily of a non-radiopaque material such as steel and can include a radiopaque section 216 made of a radiopaque material such as platinum and/or tungsten. The radiopaque section 216 can be positioned a predetermined distance from a distal end 304 of the delivery member 10a, 10b so that a physician can readily visualize the placement of the distal portion of the delivery member during a treatment procedure. The proximal section 212, radiopaque section 216 can be concentrically welded.


Proximal tube 100 can extend a majority of the length of the delivery member 10a, 10b with the coiled section 200 and the compressible distal portion 300 forming a length L that is sufficient to absorb a majority of push-back that can occur during placement of an implant at a treatment site. In some example the length L can measure between about 30 cm and about 50 cm, or more specifically, about 40 cm. According to some embodiments, the wire of coil 200 can have a width W measuring within a range including about 0.8 mils and 5 mils (about 20 nm to about 130 nm).


Delivery members 10a, 10b manufactured according to the illustrations in FIG. 1 and FIG. 2 are demonstrated to have a flexibility of about 25% to about 40% greater than competing delivery systems.


Within the proximal tube 100 of delivery members 10a, 10b can be disposed a proximal inner tube 110. Proximal inner tube 110 can provide structural rigidity to the proximal tube 100. Both delivery members 10a, 10b can include a pull wire 140 extending through lumen 608. A proximal end of the pull wire 140 can include a pull wire bead 142 which can be sized to interface with proximal inner tube 110 such that pull wire bead 142 is retained on a proximal end of proximal tube 100. A distal end 144 of the pull wire 140 can be configured to secure an implantable medical device 12 to the delivery member 10a, 10b. For example, the loop wire 400 can include a loop wire opening 405 that is positioned through a locking portion 18 of the implantable medical device 12. The distal end 144 of the pull wire 104 can then be positioned through the loop opening 405 to thereby secure the implantable medical device 12 to the delivery member 10a, 10b. Proximal ends 406, 408 of loop wire 400 can be attached to a proximal end 302 of the compressible distal portion 300. Disposed within support coil lumen 208 can be a support coil inner tube 210. Support coil inner tube 210 can provide structural rigidity to the support coil 200. Additionally, support coin inner tube 210 can include a sidewall 96.


With respect to FIGS. 1 and 2, delivery member 10a, 10b can include a pull wire portion 148 that is configured to abut a sidewall 96 of support coil inner tube 210. Pull wire portion 148 can be of any convenient shape/configuration, with exemplary configurations being discussed in more detail with respect to FIGS. 3A-3E and FIG. 8. As delivery member 10a, 10b is delivered through the vasculature of a patient to a target location of a body vessel, the pull wire 140 can experience a force that can cause the pull wire 140 to drift proximally with respect to the body 90 of the delivery member 10a, 10b. To aid in the prevention of premature detachment of the implantable medical device 12 from the detachment member 10a, 10b, a slack length SL of pull wire 140 can be included and disposed within proximal tube lumen 108. Accordingly, some proximal drift of pull wire 140 can merely remove some or all of slack length SL from the pull wire 140. Additionally, pull wire portion 148 can provide a frictional resistance between the pull wire 140 and the sidewall 96 of the support coil inner tube 210. As shown in FIGS. 1-2, pull wire portion 148 can include a portion of pull wire 140 that extends radially to abut the sidewall 96, and a portion that extends parallel to sidewall 96 and is in frictional contact with sidewall 96. The shape and configuration of pull wire portion 148 can be varied as would be understood by a person having skill in the pertinent art. 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). In some embodiments, once pull wire 140 is coated with PTFE, the pull wire portion 148 can have the PTFE coating selectively removed in order to increase the frictional resistance provided by the pull wire portion 148 against sidewall 96. The pull wire portion 148 can be configured to remain in contact with the sidewall 96 of the body 90 while the implantable medical device 12 is delivered to the target implant location. Accordingly, the frictional resistance between pull wire portion 148 and sidewall 96 of the support coil inner tube 210 can be effective to prevent premature detachment of the implantable medical device from the delivery member 10a, 10b.


With respect to FIG. 1, the pull wire portion 148 is shown having the same thickness or diameter as the remainder of pull wire 140. However, according to some embodiments, pull wire portion 148 can have a coating selectively removed, which means that pull wire portion 148 can have a diameter or thickness smaller than the remainder of pull wire 140 according to some embodiments. According to some embodiments, the coating can be a polytetrafluoroethylene coating that is selectively removed from pull wire portion 148.


With respect to FIG. 2, a delivery member 10b is shown. The delivery member 10b can be similar to the delivery member 10a as shown in FIG. 1, except delivery member 10b can include a plurality of pull wire portions 148 instead of a single pull wire portion 148 as shown in FIG. 1. As shown in FIG. 2, pull wire portion 148 can be positioned anywhere between the dashed lines (e.g., within the support coil lumen 208) and can be placed in exemplary positions P1, P2, P3. In a preferred embodiment, delivery member 10a can include a single pull wire portion 148 that can be placed at position P3 to effectively prevent premature detachment of the implantable medical device 12 from the delivery member 10a. For delivery member 10b, pull wire portion 148 can be positioned anywhere within the dashed lines. In a preferred embodiment, delivery member 10b can include at least two pull wire portions 148 positioned anywhere between positions P1 and P3. As would be understood by a person having skill in the pertinent art, the positioning and number of pull wire portions 148 can be varied. Pull wire portion 148 as shown in FIG. 2 is shown with a coating selectively removed from the pull wire portion 148. The coating can be polytetrafluoroethylene (PTFE). However, in some embodiments the delivery system 10b can include pull wire portion(s) 148 that do not have a coating selectively removed from the pull wire portion(s) 148. In some embodiments, one or more pull wire portion(s) 148 of delivery system 10b can have a coating selectively removed while the remainder of pull wire portion(s) 148 do not have the coating selectively removed. In other words, any one of pull wire portions 148 can be coated or uncoated (e.g., at positions P1, P2, P3, and/or anywhere in between positions P1 and P3 of delivery system 10b).



FIGS. 3A-3E are illustrations of exemplary pull wire portions, according to aspects of the present invention. FIG. 3A shows a triangle shape of pull wire portion 148A. As shown in FIG. 3A, triangle shape pull wire portion 148A can be implemented as a single pre-formed shape, or pull wire portion 148A can include multiple repeats of the pre-formed shape. It is also understood that a person having pertinent skill in the art could vary a gap distance D1 between repeat sections of the pull wire portion 148A.



FIG. 3B shows a trapezoidal shape of pull wire portion 148B. As seen in FIG. 3B, gap distance can be varied between repeat trapezoids of the pull wire portion 148B. FIG. 3B shows the gap distance D2 in a first example and a gap distance D3 in a second example. FIG. 3C shows a pull wire portion 148C in the shape of a corkscrew. As shown in FIG. 3C, the corkscrew shape of pull wire portion 148C can have any number of rotations. In a preferable embodiment, the pull wire portion 148C may include between approximately 1 coil and 10 coils. FIG. 3D shows a pull wire portion 148D that is in a knot configuration. The knot of pull wire portion 148D can be varied in size as would be understood by a person having skill in the pertinent art. It is also understood that knot of pull wire portion 148D can be repeated with an appropriate gap distance D4 between each knot. According to some embodiments, the gap distance D1, D2, D3, D4 can be between approximately 0.001 inches and approximately 0.1 inches. According to some embodiments, the gap distance D1, D2, D3, D4, can be such that the pull wire portions 148 fit between the dashed lines of FIG. 2 (e.g., anywhere between position P1 and position P3).



FIG. 3E shows a pull wire portion 148E having a sine wave pattern. Similarly to the corkscrew of pull wire portion 148C, the pull wire portion 148E can be repeated between approximately 1 and approximately 10 repetitions. In any case, pull wire portion 148 can be sized and shaped to provide an appropriate frictional resistance between pull wire 140 and body 90 to prevent premature detachment of implant 12 from detachment member 10a, 10b.



FIG. 4 is an illustration of embolic implant 12 being delivered through catheter 250 and positioned within an aneurysm A on a blood vessel BV. The implant can loop and bend with the aneurysm sac to form a thrombotic mass. The implant can loop back on themselves and/or loop next to other implants. As the aneurysm A becomes increasingly packed, overlapping portions of the implant 12 can press into each other.



FIG. 5 illustrates positioning of an implant 12 such as an embolic coil suitable for aneurysm treatment, a guide catheter 450, and a delivery system 10 including a body 90, distal end 94, and a pull wire 140 within tortuous vasculature (vasculature not illustrated). At bends A, B, and C, the body 90 can extend to a sidewall of the guide catheter 450 on each outer curve of each bend, and likewise, the pull wire 140 can extend to a sidewall of the body 90 on each outer curve of each bend. During a procedure, the body 90 and pull wire 140 can be fed into the guide catheter 450 in the distal direction D, first passing through bend A, then bend B, and then bend C. As the body 90 and pull wire 140 navigate the bends, the pull wire portion 148 can provide frictional resistance between the pull wire 140 and the body 90 of delivery member 10a, 10b. This frictional resistance can prevent the proximal translation in a proximal direction P of pull wire 140 with respect to the body 90 of the delivery member 10a, 10b, which prevents the premature detachment of implant 12 from the delivery member 10a, 10b.



FIGS. 6A-6D illustrate a time sequence of steps for releasing an embolic implant 12 from a delivery member 10. The delivery member 10 can be configured such as illustrated in the previous figures and as otherwise described herein. FIG. 6A illustrates an engagement system including the loop wire 400 and pull wire 140 locked into a locking portion 18 of the medical device 12. The compressible portion 306 of the compressible distal portion 300 can be compressed and the loop wire 400 opening 405 at a distal end 404 of the loop wire 400 can be placed through the locking portion 18. When the pull wire 140 is put through the opening 405 the medical device 12 is now secure. FIG. 6B illustrates the pull wire 140 being drawn proximally to begin the release sequence for the medical device 12. FIG. 6C illustrates the instant the distal end 144 of the pull wire exits the opening 405 and the pull wire 140 is pulled free of the loop wire 400. The distal end 404 of the loop wire 400 falls away and exits the locking portion 18. As can be seen, there is now nothing holding the medical device 12 to the detachment system 10. FIG. 6D illustrates the end of the release sequence. Here, the compressible portion 306 has extended/returned to its original shape and “sprung” forward. An elastic force E is imparted by the distal end 305 of the compressible distal portion 300 to the medical device 12 to “push” it away to ensure a clean separation and delivery of the medical device 12.


The compressible 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.



FIG. 7 is a flowchart 700 of an example method of using the delivery system, according to aspects of the present invention. In block 704, the method includes providing a body that includes a lumen extending therethrough and a compressible distal portion 300. In block 708, the method can include affixing a loop wire 400 to the proximal tube 100. In block 712, the method can include compressing the compressible distal portion 300. In block 716, the loop opening 405 of the loop wire 400 can be positioned at the distal end 304 of the compressible distal portion 300 while the loop wire 400 is affixed to the body 90 such that the loop wire 400 is extended through lumen 608. In block 720, the pull wire 140 can be extended through the lumen 608. In block 724, the loop opening 405 can be extended through a locking portion 18 of an implantable medical device 12. In block 728, the distal end 144 of the pull wire 140 can be extended through the loop opening 405, which can effectively secure the implantable medical device 12 to the delivery member 10a, 10b. In block 732, the method can include forming a pull wire portion 148 to abut the sidewall 96 of support coil inner tube 210 to provide a frictional resistance against the sidewall 96. In block 736, the method includes inhibiting, through the frictional resistance of the pull wire portion 148 against the sidewall 96, release of the implantable medical device 12 while the implantable medical device 12 is delivered through the vasculature to a treatment site. In block 740, a force sufficient to overcome the frictional resistance of the pull wire portion 148 of against the sidewall 96 can be provided, which can cause the proximal translation of the pull wire 140 and release of the implantable medical device 12 at the treatment site.


According to some embodiments, inhibiting release of the implantable medical device 12 can include the pull wire portion 148 remaining in contact with the sidewall 96 as the implantable medical device 12 is delivered to the target location. In some embodiments, the method can include coating the pull wire 140 with a PTFE coating and selectively removing the PTFE coating from the pull wire portion 148.


In some embodiments, providing the body 90 can further include connecting a distal end 104 of a proximal hypotube 100 to a flexible coil 200, connecting a distal end 204 of the flexible coil 200 to a proximal end 302 of the compressible distal portion 300 of the body 90, connecting the proximal tube 100, flexible coil 200, and compressible distal portion 300 to provide the body, with the body including a lumen 608 that extends through the proximal tube 100, flexible coil 200, and the compressible distal portion 300. Finally, the method can include positioning a sleeve 500 to extend along a majority of the flexible coil 200 to inhibit radial expansion of the flexible coil.



FIG. 8 is an illustration of an exemplary pull wire portion, according to aspects of the present invention. According to some embodiments, the pull wire feature 148 can be “U” shaped, with a length L2 of the pull wire portion 148 abutting the sidewall 96 of the body 90 (e.g., the interference section of the pull wire portion 148), a length L1 of the pull wire portion 148 that corresponds to the length of the feature, and a distance H1 that shows the radial displacement of the pull wire portion 148 with respect to a remainder of the pull wire 140. In addition, the pull wire portion 148 may be offset from a remainder of the pull wire 140 by an angle θ.


According to some embodiments, the pull wire portion 148 can provide a frictional resistance between the pull wire 140 and the sidewall 96 of body 90 between approximately 7.8 gram-force to approximately 22 gram-force, and in a preferred embodiment, between approximately 9 gram-force to approximately 14 gram-force. In some embodiments, the angle θ can be between approximately 140 degrees to approximately 154 degrees. In some embodiments, the radial offset H1 of the pull wire portion 148 can be a distance selected from approximately 0.0065 inches to approximately 0.0079 inches. In some embodiments, the contact surface L2 of pull wire portion 148 can be a length between approximately 0.01 inches to approximately 0.0121 inches. In some embodiments, a total length L1 of the pull wire portion 148 can be a length between approximately 0.03 inches to approximately 0.36 inches.


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.

Claims
  • 1. A delivery member for delivering an implantable medical device to a target location of a body vessel, the delivery member comprising: a body comprising a lumen extending therethrough, a compressed distal portion, and a support coil inner tube;a pull wire extending through the lumen, the pull wire comprising a pull wire portion that extends radially to abut a sidewall of the support coil inner tube thereby providing frictional resistance against the support coil inner tube;wherein the pull wire is positioned to secure the implantable medical device to the delivery member,wherein the pull wire portion is effective to inhibit premature detachment of the implantable medical device by inhibiting proximal translation of the pull wire due to the frictional resistance provided by the pull wire portion against the support coil inner tube;wherein the pull wire comprises a slack length at a proximal end of the pull wire and a straight portion distal of and approximate the slack length,wherein a distal end of the pull wire comprises a straight portion, andwherein the pull wire portion is proximal of and approximate the straight portion of the distal end of the pull wire.
  • 2. The delivery member of claim 1, wherein the pull wire is proximally movable to release the implantable medical device from the delivery member.
  • 3. The delivery member of claim 1, wherein the pull wire portion comprises a shaped feature selected from a trapezoidal-shaped feature, a triangular-shaped feature, a corkscrew-shaped feature, a knot-shaped feature, or a wave-shaped feature.
  • 4. The delivery member of claim 1, wherein the pull wire comprises stainless steel.
  • 5. The delivery member of claim 1, wherein the pull wire comprises a memory shape alloy.
  • 6. The delivery member of claim 1, wherein the pull wire is coated with a polytetrafluoroethylene coating.
  • 7. The delivery member of claim 6, wherein the polytetrafluoroethylene coating is selectively removed from the pull wire portion.
  • 8. The delivery member of claim 1, wherein the pull wire portion remains in contact with the sidewall as the implantable medical device is delivered to the target location of the body vessel.
  • 9. The delivery member of claim 1, further comprising: a loop wire comprising a first end affixed to the body and comprising a loop opening positioned approximate a distal end of the compressed distal portion.
  • 10. The delivery member of claim 9, wherein the loop wire is stretch resistant, and wherein the loop wire is under tension when the implantable medical device is secured to the delivery member.
  • 11. The delivery member of claim 10, wherein the body further comprises a flexible coil disposed in a proximal direction from the compressed distal portion, wherein the loop wire inhibits elongation of the compressed distal portion.
  • 12. The delivery member of claim 11, further comprising a sleeve that extends along a majority of the flexible coil.
  • 13. A method comprising: providing a body comprising a lumen extending therethrough, a compressible distal portion, and a support coil inner tube;compressing the compressible distal portion;extending a pull wire through the lumen;securing a distal end of the pull wire to an implantable medical device; andforming a pull wire portion of the pull wire to abut a sidewall of the support coil inner tube to provide a frictional resistance against the sidewall,wherein the pull wire comprises a slack length at a proximal end of the pull wire and a straight portion distal of and approximate the slack length,wherein a distal end of the pull wire comprises a straight portion, andwherein the pull wire portion is proximal of and approximate the straight portion of the distal end of the pull wire.
  • 14. The method of claim 13, further comprising: inhibiting, through the frictional resistance of the pull wire portion against the sidewall, release of the implantable medical device while the implantable medical device is delivered through vasculature to a treatment site; andproviding a force sufficient to overcome the frictional resistance of the pull wire portion against the sidewall, thereby translating the pull wire proximally and releasing the implantable medical device at the treatment site.
  • 15. The method of claim 13, further comprising: affixing a loop wire to the body;positioning a loop opening in the loop wire approximate a distal end of the compressible distal portion while the loop wire is affixed to the body such that the loop wire is extended through the lumen; andextending the loop opening through a locking portion of an implantable medical device.
  • 16. The method of claim 13, wherein the pull wire portion comprises a shaped feature selected from a trapezoidal-shaped feature, a triangular-shaped feature, a corkscrew-shaped feature, a knot-shaped feature, or a wave-shaped feature.
  • 17. The method of claim 13, wherein the pull wire comprises a memory shape alloy.
  • 18. The method of claim 14, wherein inhibiting release of the implantable medical device further comprises the pull wire portion remaining in contact with the sidewall as the implantable medical device is delivered to the treatment site.
  • 19. The method of claim 13, further comprising: coating the pull wire with a polytetrafluoroethylene coating; andselectively removing the polytetrafluoroethylene coating from the pull wire portion.
  • 20. The method of claim 13, wherein providing the body further comprises: connecting a distal end of a proximal hypotube to a flexible coil;connecting a distal end of the flexible coil to a proximal end of the compressible distal portion of the body;connecting the proximal hypotube, flexible coil, and compressible distal portion to provide the body comprising a lumen extending through the proximal hypotube, flexible coil, and the compressible distal portion; andpositioning a sleeve to extend along a majority of the flexible coil, thereby inhibiting radial expansion of the flexible coil.
US Referenced Citations (299)
Number Name Date Kind
2220203 Branin Feb 1939 A
3429408 Maker et al. Feb 1969 A
4858810 Intlekofer et al. Aug 1989 A
5108407 Geremia et al. Apr 1992 A
5122136 Guglielmi et al. Jun 1992 A
5234437 Sepetka Aug 1993 A
5250071 Palermo Oct 1993 A
5263964 Purdy Nov 1993 A
5334210 Gianturco Aug 1994 A
5350397 Palermo et al. Sep 1994 A
5382259 Phelps et al. Jan 1995 A
5392791 Nyman Feb 1995 A
5484409 Atkinson et al. Jan 1996 A
5569221 Houser et al. Oct 1996 A
5899935 Ding May 1999 A
5925059 Palermo et al. Jul 1999 A
6113622 Hieshima Sep 2000 A
6203547 Nguyen et al. Mar 2001 B1
6391037 Greenhalgh May 2002 B1
6454780 Wallace Sep 2002 B1
6506204 Mazzocchi Jan 2003 B2
6561988 Turturro et al. May 2003 B1
7367987 Balgobin et al. May 2008 B2
7371251 Mitelberg et al. May 2008 B2
7371252 Balgobin et al. May 2008 B2
7377932 Mitelberg et al. May 2008 B2
7384407 Rodriguez et al. Jun 2008 B2
7708754 Balgobin et al. May 2010 B2
7708755 Davis, III et al. May 2010 B2
7799052 Balgobin et al. Sep 2010 B2
7811305 Balgobin et al. Oct 2010 B2
7819891 Balgobin et al. Oct 2010 B2
7819892 Balgobin et al. Oct 2010 B2
7901444 Slazas Mar 2011 B2
7985238 Balgobin et al. Jul 2011 B2
8062325 Mitelberg et al. Nov 2011 B2
8333796 Tompkins et al. Dec 2012 B2
8926650 Que et al. Jan 2015 B2
8956381 Que et al. Feb 2015 B2
9155540 Lorenzo Oct 2015 B2
9232992 Heidner Jan 2016 B2
9314326 Wallace et al. Apr 2016 B2
9532792 Galdonik et al. Jan 2017 B2
9532873 Kelley Jan 2017 B2
9533344 Monetti et al. Jan 2017 B2
9539011 Chen et al. Jan 2017 B2
9539022 Bowman Jan 2017 B2
9539122 Burke et al. Jan 2017 B2
9539382 Nelson Jan 2017 B2
9549830 Bruszewski et al. Jan 2017 B2
9554805 Tompkins et al. Jan 2017 B2
9561125 Bowman et al. Feb 2017 B2
9572982 Burnes et al. Feb 2017 B2
9579484 Barnell Feb 2017 B2
9585642 Dinsmoor et al. Mar 2017 B2
9615832 Bose et al. Apr 2017 B2
9615951 Bennett et al. Apr 2017 B2
9622753 Cox Apr 2017 B2
9636115 Henry et al. May 2017 B2
9636439 Chu et al. May 2017 B2
9642675 Werneth et al. May 2017 B2
9655633 Leynov et al. May 2017 B2
9655645 Staunton May 2017 B2
9655989 Cruise et al. May 2017 B2
9662120 Lagodzki et al. May 2017 B2
9662129 Galdonik et al. May 2017 B2
9662238 Dwork et al. May 2017 B2
9662425 Lilja et al. May 2017 B2
9668898 Wong Jun 2017 B2
9675477 Thompson Jun 2017 B2
9675782 Connolly Jun 2017 B2
9676022 Ensign et al. Jun 2017 B2
9692557 Murphy Jun 2017 B2
9693852 Lam et al. Jul 2017 B2
9700262 Janik et al. Jul 2017 B2
9700399 Acosta-Acevedo Jul 2017 B2
9717421 Griswold et al. Aug 2017 B2
9717500 Tieu et al. Aug 2017 B2
9717502 Teoh et al. Aug 2017 B2
9724103 Cruise et al. Aug 2017 B2
9724526 Strother et al. Aug 2017 B2
9750565 Bloom et al. Sep 2017 B2
9757260 Greenan Sep 2017 B2
9764111 Gulachenski Sep 2017 B2
9770251 Bowman et al. Sep 2017 B2
9770577 Li et al. Sep 2017 B2
9775621 Tompkins et al. Oct 2017 B2
9775706 Peterson et al. Oct 2017 B2
9775732 Khenansho Oct 2017 B2
9788800 Mayoras, Jr. Oct 2017 B2
9795391 Saatchi et al. Oct 2017 B2
9801980 Karino et al. Oct 2017 B2
9808599 Bowman et al. Nov 2017 B2
9833252 Sepetka et al. Dec 2017 B2
9833604 Lam et al. Dec 2017 B2
9833625 Waldhauser et al. Dec 2017 B2
9918718 Lorenzo Mar 2018 B2
10149676 Mirigian et al. Dec 2018 B2
10285710 Lorenzo et al. May 2019 B2
10292851 Gorochow May 2019 B2
10420563 Hebert et al. Sep 2019 B2
10517604 Bowman et al. Dec 2019 B2
10668258 Calhoun et al. Jun 2020 B1
10806402 Cadieu et al. Oct 2020 B2
10806461 Lorenzo Oct 2020 B2
20010049519 Holman et al. Dec 2001 A1
20020072705 Vrba et al. Jun 2002 A1
20020165569 Ramzipoor et al. Nov 2002 A1
20030009208 Snyder et al. Jan 2003 A1
20040034363 Wilson et al. Feb 2004 A1
20040059367 Davis et al. Mar 2004 A1
20040087964 Diaz et al. May 2004 A1
20060025801 Lulo et al. Feb 2006 A1
20060064151 Guterman Mar 2006 A1
20060100687 Fahey et al. May 2006 A1
20060116711 Elliott et al. Jun 2006 A1
20060116714 Sepetka et al. Jun 2006 A1
20060135986 Wallace et al. Jun 2006 A1
20060206139 Tekulve Sep 2006 A1
20060241685 Wilson Oct 2006 A1
20060247677 Cheng et al. Nov 2006 A1
20060276824 Mitelberg et al. Dec 2006 A1
20060276825 Mitelberg et al. Dec 2006 A1
20060276826 Mitelberg et al. Dec 2006 A1
20060276827 Mitelberg et al. Dec 2006 A1
20060276830 Balgobin et al. Dec 2006 A1
20060276833 Balgobin et al. Dec 2006 A1
20070010850 Balgobin et al. Jan 2007 A1
20070055302 Henry et al. Mar 2007 A1
20070083132 Sharrow Apr 2007 A1
20070233168 Davis et al. Oct 2007 A1
20070270903 Davis, III et al. Nov 2007 A1
20080027561 Mitelberg et al. Jan 2008 A1
20080045997 Balgobin et al. Feb 2008 A1
20080082176 Slazas Apr 2008 A1
20080097462 Mitelberg et al. Apr 2008 A1
20080119887 Que et al. May 2008 A1
20080269721 Balgobin Oct 2008 A1
20080281350 Sepetka Nov 2008 A1
20080300616 Que et al. Dec 2008 A1
20080306503 Que et al. Dec 2008 A1
20090062726 Ford et al. Mar 2009 A1
20090099592 Buiser et al. Apr 2009 A1
20090312748 Johnson et al. Dec 2009 A1
20100094395 Kellett Apr 2010 A1
20100114017 Lenker et al. May 2010 A1
20100206453 Leeflang et al. Aug 2010 A1
20100324649 Mattsson Dec 2010 A1
20110092997 Kang Apr 2011 A1
20110118776 Chen et al. May 2011 A1
20110202085 Loganathan et al. Aug 2011 A1
20110295303 Freudenthal Dec 2011 A1
20120035707 Mitelberg et al. Feb 2012 A1
20120041472 Tan et al. Feb 2012 A1
20120083868 Shrivastava et al. Apr 2012 A1
20120172913 Kurrus et al. Jul 2012 A1
20120172921 Yamanaka Jul 2012 A1
20120179194 Wilson Jul 2012 A1
20120283768 Cox et al. Nov 2012 A1
20120289772 O'Connell et al. Nov 2012 A1
20130066413 Jin et al. Mar 2013 A1
20130296915 Bodewadt Nov 2013 A1
20130325054 Watson Dec 2013 A1
20140058435 Jones et al. Feb 2014 A1
20140135812 Divino et al. May 2014 A1
20140200607 Sepetka et al. Jul 2014 A1
20140243883 Tsukashima et al. Aug 2014 A1
20140277084 Mirigian Sep 2014 A1
20140277085 Mirigian et al. Sep 2014 A1
20140277092 Teoh et al. Sep 2014 A1
20140277093 Guo et al. Sep 2014 A1
20140277100 Kang Sep 2014 A1
20150005808 Chouinard et al. Jan 2015 A1
20150025562 Dinh et al. Jan 2015 A1
20150182227 Le et al. Jul 2015 A1
20150230802 Lagodzki et al. Aug 2015 A1
20150335333 Jones et al. Nov 2015 A1
20160008003 Kleshinski et al. Jan 2016 A1
20160022275 Garza Jan 2016 A1
20160022445 Ruvalcaba et al. Jan 2016 A1
20160045347 Smouse et al. Feb 2016 A1
20160157869 Elgård et al. Jun 2016 A1
20160228125 Pederson, Jr. et al. Aug 2016 A1
20160278782 Anderson et al. Sep 2016 A1
20160310304 Mialhe Oct 2016 A1
20160331383 Hebert Nov 2016 A1
20160346508 Williams et al. Dec 2016 A1
20170007264 Cruise et al. Jan 2017 A1
20170007265 Guo et al. Jan 2017 A1
20170020670 Murray et al. Jan 2017 A1
20170020700 Bienvenu et al. Jan 2017 A1
20170027640 Kunis et al. Feb 2017 A1
20170027692 Bonhoeffer et al. Feb 2017 A1
20170027725 Argentine Feb 2017 A1
20170035436 Morita Feb 2017 A1
20170035567 Duffy Feb 2017 A1
20170042548 Lam Feb 2017 A1
20170049596 Schabert Feb 2017 A1
20170071737 Kelley Mar 2017 A1
20170072452 Monetti et al. Mar 2017 A1
20170079671 Morero et al. Mar 2017 A1
20170079680 Bowman Mar 2017 A1
20170079766 Wang et al. Mar 2017 A1
20170079767 Leon-Yip Mar 2017 A1
20170079812 Lam et al. Mar 2017 A1
20170079817 Sepetka et al. Mar 2017 A1
20170079819 Pung et al. Mar 2017 A1
20170079820 Lam et al. Mar 2017 A1
20170086851 Wallace et al. Mar 2017 A1
20170086996 Peterson et al. Mar 2017 A1
20170095258 Tassoni et al. Apr 2017 A1
20170095259 Tompkins et al. Apr 2017 A1
20170100126 Bowman et al. Apr 2017 A1
20170100141 Morero et al. Apr 2017 A1
20170100143 Granfield Apr 2017 A1
20170100183 Iaizzo et al. Apr 2017 A1
20170105739 Dias Apr 2017 A1
20170113023 Steingisser et al. Apr 2017 A1
20170147765 Mehta May 2017 A1
20170151032 Loisel Jun 2017 A1
20170165062 Rothstein Jun 2017 A1
20170165065 Rothstein et al. Jun 2017 A1
20170165454 Tuohy et al. Jun 2017 A1
20170172581 Bose et al. Jun 2017 A1
20170172766 Vong et al. Jun 2017 A1
20170172772 Khenansho Jun 2017 A1
20170189033 Sepetka et al. Jul 2017 A1
20170189035 Porter Jul 2017 A1
20170215902 Leynov et al. Aug 2017 A1
20170216484 Cruise et al. Aug 2017 A1
20170224350 Shimizu et al. Aug 2017 A1
20170224355 Bowman et al. Aug 2017 A1
20170224467 Piccagli et al. Aug 2017 A1
20170224511 Dwork et al. Aug 2017 A1
20170224953 Tran et al. Aug 2017 A1
20170231749 Perkins et al. Aug 2017 A1
20170245864 Franano et al. Aug 2017 A1
20170245885 Lenker Aug 2017 A1
20170252064 Staunton Sep 2017 A1
20170258476 Hayakawa et al. Sep 2017 A1
20170265983 Lam et al. Sep 2017 A1
20170281192 Tieu et al. Oct 2017 A1
20170281331 Perkins et al. Oct 2017 A1
20170281344 Costello Oct 2017 A1
20170281909 Northrop et al. Oct 2017 A1
20170281912 Melder et al. Oct 2017 A1
20170290593 Cruise et al. Oct 2017 A1
20170290654 Sethna Oct 2017 A1
20170296324 Argentine Oct 2017 A1
20170296325 Marrocco et al. Oct 2017 A1
20170303939 Greenhalgh et al. Oct 2017 A1
20170303942 Greenhalgh et al. Oct 2017 A1
20170303947 Greenhalgh et al. Oct 2017 A1
20170303948 Wallace et al. Oct 2017 A1
20170304041 Argentine Oct 2017 A1
20170304097 Corwin et al. Oct 2017 A1
20170304595 Nagasrinivasa et al. Oct 2017 A1
20170312109 Le Nov 2017 A1
20170312484 Shipley et al. Nov 2017 A1
20170316561 Helm et al. Nov 2017 A1
20170319826 Bowman et al. Nov 2017 A1
20170333228 Orth et al. Nov 2017 A1
20170333236 Greenan Nov 2017 A1
20170333678 Bowman et al. Nov 2017 A1
20170340383 Bloom et al. Nov 2017 A1
20170348014 Wallace et al. Dec 2017 A1
20170348514 Guyon et al. Dec 2017 A1
20170367712 Johnson et al. Dec 2017 A1
20180028779 von Oepen et al. Feb 2018 A1
20180036508 Ozasa et al. Feb 2018 A1
20180078263 Stoppenhagen et al. Mar 2018 A1
20180228493 Aguilar et al. Aug 2018 A1
20180250150 Majercak et al. Sep 2018 A1
20180280667 Keren Oct 2018 A1
20180289375 Hebert et al. Oct 2018 A1
20180296222 Hebert Oct 2018 A1
20180325706 Hebert et al. Nov 2018 A1
20190142565 Follmer May 2019 A1
20190159784 Sananes et al. May 2019 A1
20190192162 Lorenzo et al. Jun 2019 A1
20190231566 Tassoni et al. Aug 2019 A1
20190255290 Snyder et al. Aug 2019 A1
20190314033 Mirigian et al. Oct 2019 A1
20190328398 Lorenzo Oct 2019 A1
20200138448 Dasnurkar et al. May 2020 A1
20200147347 Cottone May 2020 A1
20200187951 Blumenstyk Jun 2020 A1
20200229957 Bardsley et al. Jul 2020 A1
20200397444 Montidoro et al. Dec 2020 A1
20210001082 Lorenzo et al. Jan 2021 A1
20210045759 Merhi Feb 2021 A1
20210085498 Nygaard et al. Mar 2021 A1
20210186513 Hoshino et al. Jun 2021 A1
20210196281 Blumenstyk et al. Jul 2021 A1
20210213252 Lorenzo et al. Jul 2021 A1
20210338248 Lorenzo et al. Nov 2021 A1
20210346002 Lorenzo et al. Nov 2021 A1
20210353299 Hamel et al. Nov 2021 A1
20220087685 Mayer Mar 2022 A1
Foreign Referenced Citations (24)
Number Date Country
104203341 Dec 2014 CN
106456422 Feb 2017 CN
112168263 Jan 2021 CN
1985244 Oct 2008 EP
2498691 Sep 2012 EP
3061412 Aug 2016 EP
3092956 Nov 2016 EP
3501427 Jun 2019 EP
3799803 Apr 2021 EP
3854321 Jul 2021 EP
1188414 Mar 2022 EP
4119065 Jan 2023 EP
2006-334408 Dec 2006 JP
2012-523943 Oct 2012 JP
2013-78584 May 2013 JP
2014-399 Jan 2014 JP
WO 2007070793 Jun 2007 WO
2008064209 May 2008 WO
WO 2009132045 Oct 2009 WO
WO 2012158152 Nov 2012 WO
WO 2016014985 Jan 2016 WO
WO 2017066386 Apr 2017 WO
WO 2018022186 Feb 2018 WO
WO 2020148768 Jul 2020 WO
Non-Patent Literature Citations (1)
Entry
Extended European Search Report issued in European Patent Application No. 23150409.3 dated Jun. 2, 2023.
Related Publications (1)
Number Date Country
20230210531 A1 Jul 2023 US