This disclosure relates to medical instruments, and more particularly, delivery systems for a device for aneurysm therapy.
Cranial aneurysms can be complicated and difficult to treat due to their proximity to critical brain tissues. Prior solutions have included endovascular treatment whereby an internal volume of the aneurysm sac is removed or excluded from arterial blood pressure and flow. Current alternatives to endovascular or other surgical approaches can include occlusion devices that either fill the sac of the aneurysm with embolic material or treating the entrance or neck of the aneurysm. Both approaches attempt to prevent blood flow into the aneurysm. When filling an aneurysm sac, the embolic material clots the blood, creating a thrombotic mass within the aneurysm. When treating the aneurysm neck, blood flow into the entrance of the aneurysm is inhibited, inducing venous stasis in the aneurysm and facilitating a natural formation of a thrombotic mass within the aneurysm.
Current occlusion devices typically utilize multiple embolic coils to either fill the sac or treat the entrance. In either treatment, obtaining an embolic coil packing density sufficient to either occlude the aneurysm neck or fill the aneurysm sac is difficult and time consuming. Further, aneurysm morphology (e.g. wide neck, bifurcation, etc.) can required ancillary devices such a stents or balloons to support the coil mass and obtain the desired packing density.
Naturally formed thrombotic masses formed by treating the entrance of the aneurysm with embolic coils can improve healing compared to aneurysm masses packed with embolic coils by reducing possible distention from arterial walls and permitting reintegration into the original parent vessel shape along the neck plane. However, embolic coils delivered to the neck of the aneurysm can potentially have the adverse effect of impeding the flow of blood in the adjoining blood vessel; at the same time, if the entrance is insufficiently packed, blood flow can persist into the aneurysm. Properly implanting embolic coils is therefore challenging, and once implanted, the coils cannot easily be retracted or repositioned.
Furthermore, embolic coils do not always effectively treat aneurysms as aneurysms treated with multiple coils often recanalize or compact because of poor coiling, lack of coverage across the aneurysm neck, because of flow, or even aneurysm size.
An example alternative occlusion device is described in U.S. Pat. No. 8,998,947. However, this approach relies upon the use of embolic coils or mimics the coil approach and therefore suffers many of the limitations of embolic coil approaches such as difficulty achieving a safe packing density and inability to reposition once implanted.
It is therefore desirable to have a device which easily, accurately, and safely occludes a neck of an aneurysm or other arterio-venous malformation in a parent vessel without blocking flow into perforator vessels communicating with the parent vessel.
Disclosed herein are various exemplary devices and systems of the present invention that can address the above needs. The devices generally can include a delivery tube having a spiral groove on an outer surface of the delivery tube and a braided implant having a spiral segment. The spiral segment can engage the spiral groove as the braided implant is delivered to an aneurysm treatment site. At the treatment site, the braided implant can be implanted, and the delivery tube can be rotated to disengage the spiral segment from the spiral groove. Once released, the spiral segment can reshape to occlude the neck of the aneurysm.
In one example, a system can include a delivery tube and a braided implant. The delivery tube can have a lumen, a proximal end, a distal end, and an outer surface with a spiral groove positioned near the distal end. The braided implant can have a spiral segment movable from a delivery configuration that engages the spiral groove to a deployed configuration that disengages the spiral groove. A rotation of the delivery tube in relation to the implant can move the spiral segment from the delivery configuration to the deployed configuration.
In the delivery configuration, the spiral segment and the spiral groove can each have a circular helix shape, and the spiral segment can be positioned in the spiral groove.
The braided implant can include an outer fold segment attached to the spiral segment that can be positioned over a portion of the outer surface of the delivery tube, a fold that can be positioned distal the distal end of the delivery tube, and an inner fold segment having a substantially tubular structure that can be positioned within the lumen of the delivery tube.
An inner elongated member can be positioned within the lumen of the delivery tube and can have a proximal end extending proximally from the proximal end of the delivery tube and a distal end positioned within the lumen of the delivery tube detachably attached to an end of the inner fold segment of the braided implant.
The braided implant can form an occlusive sack having an opening, and the opening can be at least partially obstructed by the spiral segment when in the deployed configuration. The opening can have a perimeter and a center. In the deployed configuration, one end of the spiral segment can attach to the occlusive sack near the perimeter while the other end can terminate near the center.
The outer fold segment and the spiral segment can each have a woven structure with a woven fiber common to both segments. Alternatively, the spiral segment can have a non-woven structure.
An example device for treating an aneurysm can include a tubular delivery member, a braided tubular implant, and a coiled element. The tubular delivery member can have a lumen, a distal end, an outer surface, and a helical structure on the outer surface. The braided tubular implant can be movable from a delivery configuration having a tubular segment extending proximally within the lumen of the tubular delivery member and an outer fold segment covering a portion of the outer surface of the delivery tube member to an implanted configuration having an occlusive sack with an opening. The coiled element can be movable from an engaging configuration that engages the helical structure on the tubular delivery member to an occluding configuration that obstructs at least a portion of the opening of the occlusive sack.
In the engaged configuration, the coiled element can have a coiled segment in the shape of a circular helix that can engage the helical structure. The helical structure can be an indentation in the shape of a circular helix.
In the occluding configuration, the coiled element can have a coiled segment in the shape of a conical helix or a planar spiral. The coiled element can have an affixed portion that can be affixed to the braided implant, and the coiled segment can have an affixed end that can be affixed to the affixed portion and a terminating end. The coiled segment can be in a shape having a first circumference measured along the coiled segment from the affixed end through one turn of the conical helix or planar spiral in the direction of the terminating end and a second circumference measured along the coiled segment from the terminating end through one turn of the conical helix or planar spiral in the direction of the affixed end such that the second circumference measures shorter than the first circumference.
The coiled element can be made of a memory shape metal, and the coiled element can move from a deformed shape in the engaging configuration to a predetermined shape in the occluding configuration.
An example method for treating an aneurysm can include the steps of providing a braided implant delivery system having a delivery tube and a braided implant, engaging a spiral segment of the braided implant with a spiral groove of the delivery tube, implanting the braided implant in the aneurysm, rotating the delivery tube in relation to the spiral segment to disengage the spiral segment from the spiral groove, and releasing the spiral segment from the delivery tube which releases the braided implant from the delivery tube.
The step of implanting the braided implant in the aneurysm can include the step of forming an occlusive sack within an aneurysm, the occlusive sack having an opening.
The method can include the step of occluding at least portion of the neck of the aneurysm with the spiral segment, and the neck can be occluded by obstructing the at least a portion of the opening of the occlusive sack.
The method can include the step of moving a portion of the spiral segment from a circular helix shape to a conical helix shape.
The method can include the steps of contacting a wall of the aneurysm with the occlusive sack, and resisting, via the contact between the aneurysm wall and the occlusive sack, a rotation of the occlusive sack in response to the rotating of the delivery tube.
The step of providing the braided implantation delivery system can include providing a delivery system that additionally includes an inner elongated member, and the method can further comprise the steps of positioning the inner elongated member in a lumen of the delivery tube and attaching the braided implant to the inner elongated member. The step of implanting the braided implant in the aneurysm can further include the steps of pushing the inner elongated member distally to invert the braided implant and form an occlusive sack within the aneurysm and detaching the braided implant from the inner elongated member.
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.
Previous approaches utilizing embolic coils can be improved upon by treating the aneurysm entrance and/or packing the aneurysm with an embolic braided implant. For example, see U.S. patent application Ser. No. 15/903,860, incorporated herein, in its entirety, by reference. Treating the aneurysm with the braided implant can have potential advantages over treatments utilizing embolic coils such as a higher packing density, ability to retract and reposition the implant during the implantation procedure, ability to be implanted without ancillary devices such as stents or balloons, reduced risk of recanalizing or compacting, and improved coverage across the aneurysm neck, for example.
In braided implant delivery systems, it can be advantageous to maintain an attachment between the implant and the delivery system until the implant is in place at the treatment site, then detach the implant so that the delivery system can be extracted. When implanted in an aneurysm, for example, the delivery system can also serve to occlude the neck of the aneurysm. The present disclosure describes various example systems, devices, and methods that can be utilized for at least such purposes.
Referring to
The spiral segment 350 can be elongated with a helical, coiled, or spiral shape. The spiral segment 350 can have an attached end 354 attached to the outer fold segment 302 and can extend proximally to a terminating end 352. The spiral segment 350 can include a woven material with a weave that is common to the braided implant 300 such that the weave of the outer fold segment 302 and the weave of the spiral segment 350 share a common fiber. Alternatively, the spiral segment 350 can include a non-woven material and can be attached to the braided implant 300 by some other means.
The spiral segment 350 and the spiral groove 550 can be compatibly dimensioned so that the spiral segment 350 stays in place within the groove as the system is delivered through a catheter 600 to a treatment site. The groove can be deep enough for the spiral segment 350 to fit in without falling out. The width of the groove can be dimensioned to a fit such that the spiral segment 350 has minimal room to move within the groove.
The delivery system can be sized to be delivered to a treatment site through a catheter or microcatheter 600. The proximal end 412 of the inner elongated member 400 can extend from the proximal end 512 of the delivery tube 500, which can in turn extend from the proximal end 612 of the delivery catheter 600. The proximal end of the delivery system can be made available to a user to facilitate positioning and implantation of the braided implant 300 at a treatment site.
The braided implant 300 can include an inner fold segment 304, extending proximally during delivery and attaching at a first end 312 to the inner elongated member 400. A first end 312 of the braided implant 300 can be detachably attached to the inner elongated member 400 at a distal end 414 by a braid release 404. The inner elongated member 400 can be positioned within the lumen 504 of the delivery tube 500 having a proximal end 412 extending proximal from a proximal end 512 of the delivery tube 500.
During delivery, the inner fold segment 304 can be enveloped by the delivery tube 500 and held at the first end 312 by the inner elongated member 400. Once the delivery system is positioned at a treatment site, the inner elongated member 400 can be pushed distally, causing the inner fold segment 304 of the braided implant 300 to exit the distal end 514 of the delivery tube 500. The first end 312 of the braided implant 300 can be detached from the inner elongated member 400 at the braid release 404.
As shown in
Movement of the spiral segment 350 from the engaged configuration to the occluding configuration can be accomplished by various means. For example, the spiral segment 350 can be made with a memory shape metal having a predetermined shape and a deformed shape. In such an example, the spiral segment 350 can have a deformed shape in the engaging configuration; a rotation of the delivery tube 500 can cause the spiral segment 350 to contact bodily fluid as the spiral segment 350 exits the microcatheter 600; and the spiral segment 350 can move to the predetermined shape in response to contacting the bodily fluids, the spiral segment 350 having the predetermined shape in the occluding configuration.
Alternatively, the spiral segment 350 can be made with an elastically deformable material. In such an example, the spiral segment 350 can have a stretched shape in the engaging configuration and can be sized to fit within a spiral groove 550 on an outer surface 508 of the delivery tube 500; a rotation of the delivery tube 500 can cause the spiral segment 350 to glide off of the distal end 514 of the delivery tube 500; and the spiral segment 350, now uninhibited by the delivery tube 500, can return to its original shape, the spiral segment 350 having the original shape in the occluding configuration.
The coiled segment 220 can rotate clockwise (as shown) or counterclockwise. The coiled segment 220 can have an outer circumference 228 measured starting at the end 224 affixed to the affixed portion 210 of the coiled element in the direction of the terminating end 222 through one turn and an inner circumference 226 measured starting at the terminating end 222 through one turn in the direction of the affixed end 224. The terminating end 222 can be positioned near the center 329 of the opening 309 of the occlusive sack 308, and the affixed end 224 can be positioned at the perimeter of the opening 309. So oriented, the outer circumference 228 can measure greater than the inner circumference 226.
Referring to method 700 outlined in
Referring to method 800 outlined in
Referring to method 900 outlined in
The descriptions contained herein are examples of embodiments of the invention and are not intended to limit the scope of the invention. As described herein, the invention contemplates many variations and modifications of a system, device, or method that can be used to treat an aneurysm with a braided implant. Variations can include but are not limited to alternative geometries of elements and components described herein, utilizing any of numerous materials for each component or element (e.g. radiopaque materials, memory shape metals, etc.), utilizing additional components including components to position the braided implant at a treatment site, extract the braided implant, or eject a portion of the braided implant from the interior of the delivery tube, utilizing additional components to perform functions described herein, or utilizing additional components to perform functions not described herein, for example. These modifications would be apparent to those having ordinary skill in the art to which this invention relates and are intended to be within the scope of the claims which follow.
This application is a Continuation of U.S. application Ser. No. 16/054,055 filed on Aug. 3, 2018 which is incorporated herein by reference in its entirety.
Number | Name | Date | Kind |
---|---|---|---|
5861003 | Latson et al. | Jan 1999 | A |
6391037 | Greenhalgh | May 2002 | B1 |
8998947 | Aboytes et al. | Apr 2015 | B2 |
9232992 | Heidner | Jan 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 |
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 | Paterson 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 |
10517604 | Bowman et al. | Dec 2019 | B2 |
20030176909 | Kusleika | Sep 2003 | A1 |
20040093010 | Gesswein et al. | May 2004 | A1 |
20050187564 | Jayaraman | Aug 2005 | A1 |
20050288706 | Widomski et al. | Dec 2005 | A1 |
20060064151 | Guterman | Mar 2006 | A1 |
20070213813 | Von Segesser et al. | Sep 2007 | A1 |
20080281350 | Sepetka | Nov 2008 | A1 |
20100324649 | Mattsson | Dec 2010 | A1 |
20120283768 | Cox et al. | Nov 2012 | A1 |
20140135812 | Divino et al. | May 2014 | A1 |
20140200607 | Sepetka et al. | Jul 2014 | A1 |
20150150672 | Ma | Jun 2015 | 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 |
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 |
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 |
20170252064 | Staunton | 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 |
20170367709 | Divino et al. | Dec 2017 | A1 |
Number | Date | Country |
---|---|---|
2008036219 | Mar 2008 | WO |
Entry |
---|
Extended European Search Report issued in corresponding European Patent Application No. 19 189 856 dated Dec. 3, 2019, 14 pages. |
Number | Date | Country | |
---|---|---|---|
20210106338 A1 | Apr 2021 | US |
Number | Date | Country | |
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Parent | 16054055 | Aug 2018 | US |
Child | 17128338 | US |