Source: http://www.google.ca/patents/US9636205
Timestamp: 2018-01-20 03:36:49
Document Index: 275260556

Matched Legal Cases: ['§371', '§119', 'Application No. 61', '§119', 'Application No. 61', 'Application No. 61', 'Application No. 61']

Patent US9636205 - Intravascular blood filters and methods of use - Google Patents
Multi-filter endolumenal methods and systems for filtering fluids within the body. In some embodiments a multi-filter blood filtering system captures and removes particulates dislodge or generated during a surgical procedure and circulating in a patient's vasculature. In some embodiments a dual filter...http://www.google.ca/patents/US9636205?utm_source=gb-gplus-sharePatent US9636205 - Intravascular blood filters and methods of use
Publication number US9636205 B2
Application number US 13/497,235
PCT number PCT/US2010/047166
Also published as EP2480165A2, EP2480165A4, EP2480165B1, US20120289996, US20140243877, WO2011034718A2, WO2011034718A3
Publication number 13497235, 497235, PCT/2010/47166, PCT/US/10/047166, PCT/US/10/47166, PCT/US/2010/047166, PCT/US/2010/47166, PCT/US10/047166, PCT/US10/47166, PCT/US10047166, PCT/US1047166, PCT/US2010/047166, PCT/US2010/47166, PCT/US2010047166, PCT/US201047166, US 9636205 B2, US 9636205B2, US-B2-9636205, US9636205 B2, US9636205B2
Patent Citations (290), Non-Patent Citations (17), Classifications (12), Legal Events (4)
US 9636205 B2
providing a filter system comprising an expandable proximal filter and an expandable distal filter;
translating a proximal sheath proximally relative to the proximal filter to permit the proximal filter to expand from a collapsed configuration within the proximal sheath to an expanded configuration within a first vessel;
pulling a single pull wire to deflect a distal articulatable sheath independently of the proximal sheath and of the proximal filter and from a first configuration to a second configuration to position the distal articulatable sheath towards a second vessel, wherein in the second configuration, a distal section of the distal articulable sheath curves in a first plane and a proximal section of the distal articulatable sheath curves in a second plane, wherein the first plane is out-of-plane from the second plane, wherein pulling the single pull wire deflects a proximal section of the distal articulatable sheath and deflects a distal section of the distal articulatable sheath, and wherein the distal section of the distal articulatable sheath is configured to continue to bend without further bending the proximal section of the distal articulatable sheath when the distal section of the articulatable sheath is articulated by the single pull wire; and
advancing a tubular member carrying the expandable distal filter thereon distally from the distal articulatable sheath to permit the distal filter to expand from a collapsed configuration within the distal articulatable sheath to an expanded configuration within the second vessel.
2. The method of claim 1 wherein translating the proximal sheath relative to the proximal filter comprises translating the proximal sheath proximally relative to the distal articulatable sheath.
3. The method of claim 1, further comprising translating the distal articulatable sheath relative to the proximal filter and the proximal sheath.
4. The method of claim 1, further comprising rotating the distal articulatable sheath relative to the proximal sheath and the proximal filter.
5. The method of claim 1 wherein the deflecting step is performed after the proximal filter is expanded from the collapsed configuration to the expanded configuration.
6. The method of claim 5 wherein expanding the distal filter is performed after the deflecting step.
7. The method of claim 1 wherein the deflecting step comprises positioning a distal end of the distal articulatable sheath within the second vessel.
8. The method of claim 1 wherein the deflecting step comprises bending the proximal section of the distal articulatable sheath without bending the distal section of the distal articulatable sheath.
9. The method of claim 1 further comprising seating the distal articulatable sheath snugly against tissue between an opening of the first vessel and an opening of the second vessel to minimize the amount of the distal articulatable sheath present in a space between the opening of the first vessel and the opening of the second vessel.
10. The method of claim 1 wherein expanding the proximal filter comprises allowing the proximal filter to self-expand.
11. The method of claim 1 wherein expanding the distal filter comprises allowing the distal filter to self-expand.
12. An intravascular blood filter system, comprising:
a distal articulatable sheath disposed distal to the proximal sheath, the distal articulatable sheath comprising a distal section and a proximal section, the distal section being configured to curve in a first plane, the proximal section being configured to curve in a second plane, wherein the first plane is out-of-plane from the second plane;
a single pull wire configured to articulate the proximal section of the distal articulatable sheath and articulate the distal section of the distal articulatable sheath; and
an expandable distal filter adapted to be collapsed within the distal articulatable sheath,
wherein the distal articulatable sheath is adapted to be independently deflected relative to the proximal sheath and the proximal filter, and
wherein the distal section of the distal articulatable sheath is configured to continue bending without further bending of the proximal section of the distal articulatable sheath when the distal section of the articulatable sheath is articulated by the single pull wire.
13. The filter system of claim 12 wherein the proximal sheath is adapted to be proximally retracted relative to the proximal filter to allow the expandable proximal filter to expand from a collapsed configuration within the proximal sheath to an expanded configuration outside of the proximal sheath.
14. The filter system of claim 13 wherein the proximal filter is secured to a proximal shaft disposed within the proximal sheath, and wherein the proximal sheath is adapted to be proximally retracted relative to the proximal shaft.
15. The filter system of claim 12 wherein the distal articulatable sheath is adapted to be axially translated relative to the proximal sheath and the proximal filter.
16. The filter system of claim 12 wherein the distal articulatable sheath is adapted to be rotated relative to the proximal sheath and the proximal filter.
17. The filter system of claim 12 further comprising a tubular member carrying the distal filter.
18. The system of claim 17 wherein the tubular member is adapted to be moved distally relative to the distal articulatable sheath to permit expansion of the distal filter from a collapsed configuration within the distal articulatable sheath to an expanded configuration outside of the distal articulatable sheath.
19. The system of claim 17 wherein the distal articulatable sheath is secured to a distal shaft, and wherein the tubular member is disposed within the distal shaft and adapted to be axially movable relative to the distal shaft.
20. The filter system of claim 12 wherein the distal and proximal sheaths have substantially the same outer diameter.
21. An intravascular blood filter system comprising:
a proximal sheath secured to the handle and axially movable with respect to the proximal shaft;
a proximal filter secured to the proximal shaft, wherein the proximal sheath is axially movable with respect to the proximal filter;
a distal articulatable sheath secured to the distal shaft and axially movable with respect to the proximal sheath, the distal articulatable sheath comprising a distal section and a proximal section, the distal section being configured to curve in a first plane, the proximal section being configured to curve in a second plane, wherein the first plane is out-of-plane from the second plane;
a single pull wire having a length with a proximal end and a distal section; the pull wire proximal end being secured to the handle and the pull wire distal section being secured to the distal articulatable sheath, the single pull wire configured to articulate the proximal section of the distal articulatable sheath and to articulate the distal section of the distal articulatable sheath, the distal section of the distal articulatable sheath being configured to continue bending without further bending of the proximal section of the distal articulatable sheath when the distal section of the articulatable sheath is articulated by the single pull wire;
22. The intravascular blood filter system of claim 21 wherein the handle comprises a first handle section secured to the proximal sheath and a second handle section secured to the distal shaft.
23. The intravascular blood filter system of claim 22 wherein the first handle section houses a proximal hub secured to the proximal sheath, and wherein the proximal hub is adapted to cause axial movement of the proximal sheath.
24. The intravascular blood filter system of claim 22 wherein the second handle section further comprises a deflection control.
25. The intravascular blood filter system of claim 24 further comprising:
wherein the distal shaft is secured to the deflection control; and
whereby movement of either the deflection control or the second handle section relative to and in a direction away from each other tensions the pull wire thereby causing deflection of the distal articulatable sheath.
26. The intravascular blood filter system of claim 21 wherein the proximal filter is configured as an oblique truncated cone.
27. The intravascular blood filter system of claim 26 wherein the proximal filter comprises an expandable frame comprising a stiffening element extending at least partially along a length of the proximal filter.
28. The intravascular blood filter system of claim 21 wherein the proximal filter comprises an oblique truncated conical filter with an expandable frame and a stiffening element extending along a length thereof from a point proximate the proximal shaft to a point proximate the shorter length of the oblique truncated conical filter.
This application is a United States national phase under 35 U.S.C. §371 of PCT Application No. PCT/US2010/047166, filed Aug. 30, 2010, entitled “Intravascular Blood Filters and Methods of Use ” which is hereby incorporated by reference in its entirety and which is a continuation-in-part of U.S. application Ser. No. 12/689,997, filed Jan. 19, 2010, which claims priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Patent Application No. 61/145,149, filed Jan. 16, 2009, both of which are incorporated herein by reference. This application also claims priority benefit under 35 U.S.C. §119(e) of U.S. Provisional Application No. 61/244,418, filed Sep. 21, 2009; U.S. Provisional Application No. 61/334,893, filed May 14, 2010; and U.S. Provisional Application No. 61/348,979, filed May 27, 2010, all of which are incorporated herein by reference.
FIG. 6A illustrates a portion of a filter delivery system in a delivery configuration, and FIG. 6B illustrates that the distal articulating sheath is independently movable relative to the proximal sheath and proximal filter.
FIGS. 7A, 7B, and 7C illustrate a portion of an exemplary filter system.
FIGS. 9A, 9B, and 9C show an exemplary embodiment of a distal sheath with slots formed therein.
FIGS. 2A-2D illustrate a merely exemplary embodiment of a method of using any of the filter systems described herein. System 10 from FIGS. 1A-1C is shown in the embodiment in FIGS. 2A-2D. System 10 is advanced into the subject's right radial artery through an incision in the right arm. The system is advanced through the right subclavian artery and into the brachiocephalic trunk 11, and a portion of the system is positioned within aorta 9 as can be seen in FIG. 2A (although that which is shown in FIG. 2A is not intended to be limiting). Proximal sheath 12 is retracted proximally to allow proximal filter support element 15 to expand to an expanded configuration against the wall of the brachiocephalic trunk 11, as is shown in FIG. 2B. Proximal filter element 17 is secured either directly or indirectly to support element 15, and is therefore reconfigured to the configuration shown in FIG. 2B. The position of distal sheath 20 can be substantially maintained while proximal sheath 12 is retracted proximally. Once expanded, the proximal filter filters blood traveling through the brachiocephalic artery 11, and therefore filters blood traveling into the right common carotid artery 7. The expanded proximal filter is therefore in position to prevent foreign particles from traveling into the right common carotid arterty 7 and into the cerebral vasculature. Distal sheath 20 is then steered, or bent, and distal end 26 of distal sheath 20 is advanced into the left common carotid artery 13, as shown in FIG. 2C. Guiding member 24 is thereafter advanced distally relative to distal sheath 20, allowing the distal support element to expand from a collapsed configuration against the wall of the left common carotid artery 13 as shown in FIG. 2D. The distal filter element is also reconfigured into the configuration shown in FIG. 2D. Once expanded, the distal filter filters blood traveling through the left common carotid artery 13. The distal filter is therefore in position to trap foreign particles and prevent them from traveling into the cerebral vasculature.
FIGS. 9A, 9B, and 9C show an alternative embodiment of distal sheath 48 that includes slots 50 formed therein. The slots can be formed by, for example, grinding, laser cutting or other suitable material removal from distal sheath 48. The characteristics of the slots can be varied to control the properties of the distal sheath. For example, the pitch, width, depth, etc., of the slots can be modified to control the flexibility, compressibility, torsional responsiveness, etc., of distal sheath 48. More specifically, the distal sheath 48 can be formed from a length of stainless steel hypotubing. Transverse slots 50 are preferably formed on one side of the hypotubing.
FIG. 9B shows a further embodiment of the distal sheath in greater detail. In this embodiment distal sheath 48 includes a first proximal articulatable hypotube section 49. Articulatable hypotube section 49 is fixed to distal shaft 30 (not shown in FIG. 9B). A second distal articulatable section 51 is secured to first proximal section 49. Pull wire 38 extends from the handle to both distal shaft sections 49 and 51. This embodiment allows for initial curvature of distal sheath proximal section 49 away from the outer vessel wall. Distal sheath distal section 51 is then articulated to a second curvature in the opposite direction. This second curvature of distal shaft section 51 is adjustable based upon tension or compression loading of the sheath section by pull wire 38.
As shown in FIG. 9B, pull wire 38 crosses to an opposite side of the inner lumen defined by sections 49 and 51 as it transitions from the first proximal distal sheath section 49 to distal sheath distal section 51. As best shown in FIG. 9C, distal sheath proximal section 49 would articulate first to initialize a first curve. And, as the tension on pull wire 38 is increased, distal sheath distal section 51 begins to curve in a direction opposite to the direction of the first curve, due to pull wire 38 crossing the inner diameter of the lumen through distal sheath sections 49 and 51. As can be seen in FIG. 9C, as it nears and comes to the maximum extent of its articulation, distal sheath distal section 51 can take the form of a shepherd's staff or crook.
FIGS. 12A and 12B illustrates an exemplary curvature of a distal sheath to help position the distal filter properly in the left common carotid artery. In FIGS. 12A and 12B, only a portion of the system is shown for clarity, but it can be assumed that a proximal filter is included, and in this example has been expanded in brachiocephalic trunk 111. Distal shaft 110 is coupled to steerable distal sheath 112. Distal sheath 112 is steered into the configuration shown in FIG. 12B. The bend created in distal sheath 112, and therefore the relative orientations of distal sheath 112 and left common carotid artery 113, allow for the distal filter to be advanced from distal sheath 112 into a proper position in left common carotid 113. In contrast, the configuration of distal sheath 114 shown in phantom in FIG. 12A illustrates how a certain bend created in the distal sheath can orient the distal sheath in such a way that the distal filter will be advanced directly into the wall of the left common carotid (depending on the subject's anatomy), which can injure the wall and prevent the distal filter from being properly deployed. Depending on the angulation, approach angle, spacing of the openings, etc., a general U-shaped curve (shown in phantom in FIG. 12A) may not be optimal for steering and accessing the left common carotid artery from the brachiocepahlic trunk.
Once in the aortic space, the distal sheath is further tensioned to adjust the curvature of the distal shaft distal section 51, as shown in FIG. 9C. The amount of deflection is determined by the operator of the system based on the particular patient anatomy.
FIGS. 19A-19C illustrate exemplary embodiments of proximal filters and proximal shafts that can be incorporated into any of the systems herein. In FIG. 19A, filter 230 has flared end 232 for improved filter-wall opposition. FIG. 19B shows proximal shaft 244 substantially co-axial with vessel 246 in which filter 240 is expanded. Vessel 246 and shaft 244 have common axis 242. FIG. 19B illustrates longitudinal axis 254 of shaft 256 not co-axial with axis 252 of lumen 258 in which filter 250 is expanded.
FIGS. 31A-31C illustrate an exemplary over-the-wire routing system that includes a separate distal port for a dedicated guidewire. A portion of the system is shown in FIG. 31A, including distal articulating sheath 662 and proximal sheath 660 (the filters are collapsed therein). FIG. 31B is a highlighted view of a distal region of FIG. 31A, showing guidewire entry port 666 near the distal end 664 of distal sheath 662. FIG. 31C is a sectional view through plane A of distal sheath 662, showing guidewire lumen 672, spine element 678, distal filter lumen 674, and steering element 676 (shown as a pullwire). Guidewire lumen 672 and distal filter lumen 674 are bi-axial along a portion of distal sheath, but in region 670 guidewire lumen 672 transitions from within the wall of distal sheath 662 to being co-axial with proximal sheath 660.
FIGS. 32A-32E illustrate an exemplary routing system which includes a rapid-exchange guidewire delivery. The system includes distal articulating sheath 680 with guidewire entry port 684 and guidewire exit port 686. The system also includes proximal sheath 682, a distal filter secured to a guiding member (collapsed within distal sheath 680), and a proximal filter (collapsed within proximal sheath 682). After guidewire 688 is advanced into position within the patient, the proximal end of guidewire 688 is advanced into guidewire entry port 684. Distal sheath (along with the proximal sheath) is tracked over guidewire 688 until guidewire 688 exits distal sheath 680 at guidewire exit port 686. Including a guidewire exit port near the entry port allows for only a portion of the guidewire to be within the sheath(s), eliminating the need to have a long segment of guidewire extending proximally from the subject's entry point. As soon as the guidewire exits the exit port, the proximal end of the guidewire and the proximal sheath can both be handled. FIG. 32B shows guidewire 688 extending through the guidewire lumen in the distal sheath and extending proximally from exit port 686. Guidewire 688 extends adjacent proximal sheath 682 proximal to exit port 686. In FIG. 32B, portion 690 of proximal sheath 682 has a diameter larger than portion 692 to accommodate the proximal filter therein. Portion 692 has a smaller diameter for easier passage of the proximal sheath and guidewire. FIG. 32C shows a sectional view through plane A, with guidewire 688 exterior and adjacent to proximal sheath 682.
Proximal filter 694 is in a collapsed configuration within proximal sheath 682, and guiding member 696 is secured to a distal filter, both of which are disposed within distal shaft 698. FIG. 32D shows relative cross-sections of exemplary introducer 700, and distal sheath 680 through plane CC. Distal sheath 680 includes guidewire lumen 702 and distal filter lumen 704. In some embodiments, introducer 700 is 6 F, with an inner diameter of about 0.082 inches. In comparison, the distal sheath can have a guidewire lumen of about 0.014 inches and distal filter lumen diameter of about 0.077 inches. In these exemplary embodiments, as the distal sheath is being advanced through an introducer sheath, the introducer sheath can tent due to the size and shape of the distal sheath. There may be some slight resistance to the advancement of the distal sheath through the introducer sheath. FIG. 32E shows a sectional view through plane B, and also illustrates the insertion through introducer 700. Due to the smaller diameter of portion 692 of proximal sheath 682, guidewire 688 and proximal sheath 682 more easily fit through introducer 700 than the distal sheath and portion of the proximal sheath distal to portion 692. Introducer is 6 F, while proximal sheath is 5 F. Guidewire 688 is a 0.014 inch diameter guidewire. The smaller diameter proximal portion 692 of proximal sheath 682 allows for optimal sheath and guidewire movement with the introducer sheath.
FIG. 35 illustrates another exemplary embodiment of a handle that can be used with any of the filter systems described herein. In this alternate embodiment the handle is of a 3-piece design. This a-piece handle design comprises a first proximal piece which includes distal sheath actuator 761, which includes handle section 763 and deflection control knob 765. Deflection control knob 765 of distal sheath actuator 761 is secured to distal shaft 767. Axial movement of distal sheath actuator 761 will translate distal shaft 767 either distally or proximally relative to the proximal filter and proximal sheath. A pull wire (not shown in FIG. 35) is secured to handle section 763 and to the distal articulatable sheath (not shown in FIG. 35). Axial movement of deflection control knob 765 applies tension, or relieves tension depending on the direction of axial movement of deflection control knob 765, to control the deflection of the distal articulatable sheath relative to the proximal filter and proximal sheath 769. Rotation of distal sheath actuator 761 will rotate the distal sheath relative to the proximal filter and proximal sheath 769. The handle design further includes a second piece comprising central section 760 which is secured to proximal shaft 771. A third distal piece of this handle design includes housing 762. Housing 762 is secured to proximal sheath 769. Housing 762 is adapted to move axially with respect to central section 760. With central section 760 held fixed in position, axial movement of housing 762 translates to axial movement of proximal sheath 769 relative to proximal shaft 771. In this manner, proximal filter 773 is either released from the confines of proximal sheath 769 into expandable engagement within the vessel or, depending on direction of movement of housing 762, is collapsed back into proximal sheath 769.
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International Classification A61F2/01, A61M25/01
Cooperative Classification A61F2230/008, A61M25/0105, A61M25/0152, A61F2230/0008, A61F2/013, A61M25/0138, A61F2230/0006, A61M25/0147, A61F2230/0067, A61F2002/018
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:LEE, MICHAEL;FIFER, DANIEL W.;LASHINSKI, RANDALL T.;REEL/FRAME:028370/0920