The present invention generally relates to medical devices and methods which can be used to remove an obstruction in a blood vessel within a patient, and more particularly, to devices for capturing obstructions in cerebral arteries.
Accessing the neurovascular is difficult with conventional technology as the target vessels are small in diameter, are remote relative to the site of insertion, and are highly tortuous compared to blood vessels typically treated by conventional technology. Even though there are over 600,000 acute ischemic strokes in the US each year, clot retrieval devices are used to treat patients in less than <1% of cases. The reasons for this are that conventional technology is either too large in profile, lacks the deliverability to navigate tortuous vessels or is not effective at removing clot when delivered to the target site.
Navigating vessels to approach brain arteries can be difficult due to the aortic arch (especially with in patients with type 2 or type 3 aortic arches), vessel segments having sharp, frequent bends, and the fragility of neurovascular vessels compared to similarly sized vessels in other parts of the body.
Once a device is delivered to the treatment site, the obstruction (e.g. clot, misplaced device, migrated device, large emboli, etc.) can be difficult to dislodge, especially if hours have passed before a patient is catheterized. Pulsing blood pressure and fibrin formation between the obstruction and the vessel wall can strongly adhere the obstruction to the vessel wall. Once dislodged, any portion of the obstruction that is not captured and retrieved can be carried in the direction of blood flow. An ischemic stroke affecting new territory can result if the free obstruction portion lodges elsewhere in the cerebral vasculature.
There therefore exists a need for a vasculature obstruction capture device capable of capturing an obstruction within a cerebral artery for safe retrieval from the patient.
Disclosed herein are various exemplary devices of the present invention that can address the above needs, the devices generally can include an expandable element, an invertible element, a gap positioned between the expandable element and the invertible element, and an elongated member for delivering the elements to the site of the obstruction. In this manner, the devices permit for an obstruction to be captured within the gap by enveloping the obstruction within a pocket formed by inverting the inverting element.
In one example, the device for capturing an obstruction in a vasculature can include a first elongated member, an expandable element, an invertible element, and a gap. The expandable element and the invertible element can be positioned near the distal end of the first elongated member with a gap in between sized to be placed across the obstruction. The expandable element can expand from a collapsed delivery configuration to an expanded configuration. The invertible element can expand from a collapsed delivery configuration to an expanded configuration, and the invertible element can invert from the expanded configuration to an inverted configuration, thereby forming a pocket. The pocket can envelope at least a portion of the gap and can thereby capture an obstruction that is in the gap.
The expandable element can be positioned distal to the invertible element. The gap can be positioned between a first joint joining the expandable element and the first elongated member and a second joint joining the invertible element and the first elongated member.
The device can include a core wire with a distal coil positioned near the distal end of the core wire. The core wire can be movable in relation to the first elongated member, such that the movement expands the expandable element. The expanded size of the expandable element, or a radius of expansion, can be controlled by the movement of the core wire in relation to the first elongated member.
The device can include a second elongated member movable in relation to the first elongated member, such that the movement expands the invertible element. Moving the first elongated member in relation to the second elongated member can also invert the invertible element. Inverting the invertible element can cause at least a portion of the gap to be enveloped by the pocket formed by inverting the invertible element.
The expandable element and the invertible elements can each be expandable to the walls of the vasculature.
Another example of the device can include a clot engaging element positioned between the expandable element and the invertible element. The expandable element, invertible element, and clot engaging element can each be disposed near the distal end of the first elongated member. The clot engaging element can have a collapsed delivery configuration and can self-expand to an expanded deployed configuration. In the expanded configuration, a portion of the clot engaging element can engage the clot, then upon movement of the clot engaging element, the clot engaging element can pinch the clot in a clot pinching configuration.
At least a portion of the clot engaging element can be enveloped by the invertible element when the invertible element is in the inverted configuration.
The expandable element can be positioned distal the invertible element, and the clot engaging element can be positioned distal the invertible element and proximal the expandable element.
In another example, a method of capturing an obstruction with an obstruction capturing device having a core wire, an expandable element, an invertible element, and a gap positioned between the expandable element and the invertible element can include the steps of providing the obstruction capturing device, placing the gap across the obstruction, expanding the expandable element from a collapsed delivery configuration to an expanded configuration, expanding the invertible element from a collapsed delivery configuration to an expanded configuration, inverting the invertible element from the expanded configuration to an inverted configuration to form a pocket, enveloping at least a portion of the gap by the pocket, and capturing the obstruction in the pocket.
The method can further include enveloping the obstruction within a cavity formed by the pocket and a surface of the expandable element.
The provided device can have a core wire, a first elongated member, and a second elongated member. In this example, the method can further include the steps of moving the core wire relative to the first elongated member to cause the expanding of the expandable element, moving the first elongated member relative to the second elongated member to cause the expanding of the invertible element, moving the first elongated member relative to the second elongated member to cause the inverting of the invertible element, moving the first elongated member relative to the second elongated member to cause the enveloping of the at least a portion of the gap, and moving the first elongated member relative to the second elongated member to cause the capturing of the obstruction in the pocket.
The provided device can have a clot engaging element. In this example the method can include the steps of expanding the clot engaging element from a collapsed delivery configuration to an expanded configuration, thereby engaging the obstruction, and moving the clot engaging element from the expanded configuration to a clot pinching configuration, thereby pinching the obstruction.
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.
An example of an obstruction capturing device 110, as illustrated in
As shown, the first elongated member can be an inner tube 115 having a lumen therethrough, a proximal end, and a distal end. The inner tube 115 can be connected to the expandable element 112 and the invertible element 113. For example, the inner tube 115 can be joined to the proximal end of the expandable element 112 at a joint 119, the inner tube 115 can be joined to the distal end of the invertible element 113 at a joint 120, and the joints 119, 120 to the inner tube 115 define the gap 125 between the expandable element 112 and the invertible element 113.
The obstruction capturing device 110 can include additional elongated members such as an outer tube 114 and a core wire 116. As shown in
The core wire 116 can be connected to a distal coil 111 and the expandable element 112. For example, the core wire 116 can be joined to the distal coil 111 at two joints 117 on the distal and proximal ends of the distal coil 111, and the core wire 116 can be joined to the expandable element 112 at a joint 118 on the distal end of the expandable element 112.
The outer tube 114 can be connected to the invertible element 113. For example, the outer tube 114 can be connected to the proximal end of the invertible element 113 at a joint 121.
As shown in
The expandable element 112 can have a flexible structure, such as a mesh, capable of expanding radially when longitudinally compressed or collapsing under longitudinal strain. In such an example, the radius of the expandable element 112 can be controlled by the longitudinal movement of the inner tube 115 in relation to the core wire 116. In certain applications, the radius of expansion can thereby extend to the wall of a vasculature.
Other configurations of the obstruction capturing device not shown are contemplated. For example, an invertible element may be positioned distal a proximal element. In such a configuration, the invertible element can be joined to a core wire at a distal joint and jointed to an inner tube at a proximal joint. The expandable element can be joined to the inner tube at a distal joint and joined to an outer tube at a proximal joint. The core wire, inner tube, and outer tube can be elongated members movable by an operator. In such a configuration, moving the outer tube in relation to the inner tube can expand the expandable element, and moving the inner tube in relation to the core wire can expand and invert the invertible element. The invertible element can invert to form a pocket that has an opening that faces proximally. A cavity can be formed within the pocket of the invertible element capped by an adjacent surface of the expandable element. An example method for use of the device in this configuration can include, positioning the gap across an obstruction, pushing the outer tube distally to expand the expandable element, pushing the inner and outer tubes distally to expand and invert the invertible element and envelope the obstruction, moving the microcatheter distally to envelope the device, and extracting the microcatheter from a patient with the device and obstruction contained therein.
The expandable element 112 can be expanded by means not shown. For example, the expandable element 112 can be self-expanding. In such an example, the expandable element 112 can be constrained during delivery by the outer tube 114 or other means and then allowed to expand once the device is positioned to capture the obstruction.
As shown in
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 obstruction capturing device, including varied relative positioning of the expanding element, inverting element, and clot engaging element, varied configurations utilizing elongated members such as a core wire or concentric tubes, utilizing any of numerous materials for each element or member, incorporation of additional elements or members, utilizing self-expanding elements, or controlling the expansion of elements by moving members 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. 16/007,168 filed on Jun. 13, 2018 which is incorporated herein by reference in its entirety herein into this application as if set forth in full.
Number | Name | Date | Kind |
---|---|---|---|
6066149 | Samson et al. | May 2000 | A |
6210370 | Chi-Sing et al. | Apr 2001 | B1 |
6391037 | Greenhalgh | May 2002 | B1 |
6485502 | Don Michael et al. | Nov 2002 | B2 |
7214237 | Don Michael et al. | May 2007 | B2 |
8088140 | Ferrera et al. | Jan 2012 | B2 |
8945172 | Ferrera et al. | Feb 2015 | B2 |
9232992 | Heidner | Jan 2016 | B2 |
9351749 | Brady et al. | May 2016 | B2 |
9358022 | Morsi | Jun 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 |
9743944 | Bonneau et al. | Aug 2017 | B1 |
9750565 | Bloom et al. | Sep 2017 | B2 |
9757260 | Greenan | Sep 2017 | B2 |
9764111 | Gulachenski | Sep 2017 | B2 |
9770251 | Bowman | 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 |
20020062135 | Mazzocchi et al. | May 2002 | A1 |
20020072764 | Sepetka et al. | Jun 2002 | A1 |
20050038447 | Huffmaster | Feb 2005 | A1 |
20060015136 | Besselink | Jan 2006 | A1 |
20060064151 | Guterman | Mar 2006 | A1 |
20070078481 | Magnuson | Apr 2007 | A1 |
20080281350 | Sepetka | Nov 2008 | A1 |
20100268265 | Krolik et al. | Oct 2010 | A1 |
20100324649 | Mattsson | Dec 2010 | A1 |
20110202088 | Eckhouse et al. | Aug 2011 | A1 |
20110213403 | Aboytes | Sep 2011 | A1 |
20120116443 | Ferrera et al. | May 2012 | A1 |
20120283768 | Cox et al. | Nov 2012 | A1 |
20130184739 | Brady et al. | Jul 2013 | A1 |
20130197567 | Brady et al. | Aug 2013 | A1 |
20130345739 | Brady et al. | Dec 2013 | A1 |
20140135812 | Divino et al. | May 2014 | A1 |
20140142598 | Fulton, III | May 2014 | A1 |
20140200607 | Sepetka et al. | Jul 2014 | A1 |
20140200608 | Brady et al. | Jul 2014 | A1 |
20140249565 | Laine | Sep 2014 | A1 |
20140316428 | Golan | Oct 2014 | A1 |
20150196744 | Aboytes | Jul 2015 | A1 |
20150223829 | Aboytes | Aug 2015 | A1 |
20150265299 | Cooper et al. | Sep 2015 | A1 |
20160192953 | Brady et al. | Jul 2016 | A1 |
20160192954 | Brady et al. | Jul 2016 | A1 |
20160192955 | Brady et al. | Jul 2016 | A1 |
20160192956 | Brady et al. | Jul 2016 | A1 |
20160206344 | Bruzzi et al. | Jul 2016 | A1 |
20160354098 | Martin 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 |
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 |
Number | Date | Country |
---|---|---|
104159525 | Nov 2014 | CN |
104768479 | Jul 2015 | CN |
105208950 | Dec 2015 | CN |
1 452 142 | Aug 2004 | EP |
2001-522639 | Nov 2001 | JP |
2009-509719 | Mar 2009 | JP |
2010102307 | Sep 2010 | WO |
WO 2014055609 | Apr 2014 | WO |
Entry |
---|
Extended European Search Report issued in corresponding European Patent Application No. 19 17 9707 dated Aug. 6, 2019. |
Communication pursuant to Article 94(3) EPC issued in corresponding European Patent Application No. 19 179 707 dated Aug. 27, 2020. |
Number | Date | Country | |
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20210113227 A1 | Apr 2021 | US |
Number | Date | Country | |
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Parent | 16007168 | Jun 2018 | US |
Child | 17133826 | US |