Source: https://patents.google.com/patent/US8734479B2/en
Timestamp: 2020-01-25 07:58:31
Document Index: 535938429

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60', 'Application No. 60']

US8734479B2 - Embolus blood clot filter delivery system - Google Patents
US8734479B2
US8734479B2 US12/096,783 US9678306A US8734479B2 US 8734479 B2 US8734479 B2 US 8734479B2 US 9678306 A US9678306 A US 9678306A US 8734479 B2 US8734479 B2 US 8734479B2
US12/096,783
US20090318951A1 (en
2006-12-29 Priority to US12/096,783 priority patent/US8734479B2/en
2008-05-13 Assigned to C.R. BARD INC. reassignment C.R. BARD INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CHANDUSZKO, ANDRZEJ J., KASHKAROV, ALEXANDER GERMANOVICH
2008-07-22 Assigned to C.R. BARD INC. reassignment C.R. BARD INC. CORRECTIVE ASSIGNMENT TO CORRECT THE ERRONEOUS FIRST PAGE OF THE ASSIGNMENT PREVIOUSLY RECORDED ON REEL 020942 FRAME 0757. ASSIGNOR(S) HEREBY CONFIRMS THE ASSIGNMENT. Assignors: CHANDUSZKO, ANDRZEJ J., KASHKAROV, ALEXANDER GERMANOVICH
2009-12-24 Publication of US20090318951A1 publication Critical patent/US20090318951A1/en
2010-05-26 Assigned to C.R. BARD, INC. reassignment C.R. BARD, INC. ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: CHANDUSZKO, ANDRZEJ J., KASHKAROV, ALEXANDER GERMANOVICH
2014-05-27 Publication of US8734479B2 publication Critical patent/US8734479B2/en
210000004369 Blood Anatomy 0 abstract claims description title 85
210000004204 Blood Vessels Anatomy 0 abstract claims description 68
-1 Cobalt-Chromium-Nickel Chemical compound 0 description 4
This is a National Stage application under 35 U.S.C. 371 of International Application No. PCT/US2006/062725, filed Dec. 29, 2006, which claims the benefit of priority to U.S. Provisional Patent Application No. 60/754,636, filed Dec. 30, 2005 each of which is incorporated by reference in its entirety. This invention is related to the subject matter shown and described in the following: (i) PCT International Application No. PCT/US06/62722, filed Dec. 29, 2006, entitled “Removable Blood Clot Filter with Edge For Cutting Through the Endothelium” and claiming the benefit of priority to U.S. Provisional Patent Application No. 60/754,600, filed Dec. 30, 2005; (ii) PCT International Application No. PCT/US06/62719, filed Dec. 29, 2006, entitled “Embolus Blood Clot Filter with Post Delivery Actuation,” and claiming the benefit of priority to U.S. Provisional Patent Application No. 60/754,633, filed Dec. 30, 2005; (iii) PCT International Application No. PCT/US06/62733, filed Dec. 29, 2006, entitled “Embolus Blood Clot Filter Removal System and Method,” and claiming the benefit of priority to U.S. Provisional Patent Application No. 60/754,598, filed Dec. 30, 2005; (iv) PCT International Application No. PCT/US06/62720, filed Dec. 29, 2006, entitled “Embolus Blood Clot Filter with Floating Filter Basket,” and claiming the benefit of priority to U.S. Provisional Patent Application No. 60/754,599, filed Dec. 30, 2005; and (v) PCT International Application No. PCT/US06/62730, filed Dec. 29, 2006, entitled “Embolus Blood Clot Filter with Bio-Resorbable Coated Filter Members,” and claiming the benefit of priority to U.S. Provisional Patent Application No. 60/754,597, entitled “Embolus Blood Clot Filter with Retainers on Locator Filter Members,” filed Dec. 30, 2005, each of which is hereby incorporated by reference in its entirety.
This invention relates to a device for delivering a blood filter into a vessel of a patient's body to reduce the risk of embolisms.
In recent years, a number of medical devices have been designed which are adapted for compression into a small size to facilitate introduction into a vascular passageway and which are subsequently expandable into contact with the walls of the passageway. These devices include, among others, blood clot filters, which expand and are held in position by engagement with the inner wall of a vein, such as the vena cava. These vena cava filters are generally designed to remain in place permanently. Typically, blood filters are made of metal wire in a configuration designed to fill the cross section of the blood vessel with filter members. Such filters must be radially compressed to fit within a delivery catheter, and these filters include structure to anchor the filter in place within the vena cava, such as elongate diverging anchor members with hooked ends that penetrate the vessel wall and positively prevent longitudinal migration of the filter in either direction within the vessel.
The various embodiments provide for blood filter delivery systems that alleviate the deficiencies of known delivery systems and filters. In an embodiment, an apparatus for pushing a blood filter from a delivery catheter includes a plurality of positioner or positioning members coupled to the distal end of a push rod assembly. The positioner members are configured so that they will fit over the hooked ends of the filter anchor members, gripping the anchor members when the filter and positioner members are situated in a catheter or storage tube. The positioner members are shaped and coupled to a hub on the push rod assembly so that when they extend beyond the end of the catheter, the positioner members bend away from the centerline of the catheter and push rod assembly. The positioner members are sized and shaped so that their distal ends will contact and push against the blood vessel wall before the filter or the entire positioner member is beyond the end of the catheter. By pressing on the blood vessel wall, the positioner members bring the end of the catheter into near alignment with the centerline of the blood vessel. The positioning action happens before the filter's anchor members are released by the positioner members.
The accompanying drawings, which are incorporated herein and constitute part of this specification, illustrate presently preferred embodiments of the invention, and, together with the general description given above and the detailed description given below, explain features of the invention.
FIG. 13A is a side view of an embodiment of the filter positioning assembly including a spline near its base to contain the filter anchor members.
The various elements of the push rod assembly 60 may be made from different materials. For example, the handle 61 may be formed of a number of metallic, polymer or plastic materials, and is preferably formed from PEBA, which is coupled to a stainless steel hollow section 63 having a diameter of about 0.041 inches. The hollow stainless steel tube 63 may be connected to a suitable alloy material wire 64, including, for example, a super-elastic shape memory alloy (e.g., Nitinol), on which various elements can be disposed, such as a stop or boss portion 65. The shape memory alloy can further be defined as preferably having an austenite finish (Af) temperature below body temperature. The stainless steel hollow section 63 may be coupled to an extended wire 64, which may be made from stainless steel, the Cobalt-Chromium-Nickel alloy known as Elgiloy®, or a super-elastic shape memory alloy, such as Nitinol. A terminal portion 67, positioned at the distal end of the extended portion 62, may have a smaller diameter than the wire 64, 66 and can be made from stainless steel or Elgiloy®, and more preferably is made of Nitinol. In a preferred embodiment, the terminal portion 67 has a diameter of about 0.020 inches.
When the ends of the positioner members 72 press against the vessel wall, the resulting spring force is transferred to the hub 71, and thereby provide a means to pus the hub 71—and with it the end of the catheter 16—toward the point of equal force among the various positioner members 72, which will normally be at or near the centerline of the blood vessel. In order to hold the positioner members 72 in their flexed configuration and receive the applied force, the positioner members 72 must be securely coupled to the hub 71. The positioner members 72 may be so coupled to the hub 71 by welding or brazing, or the hub 71 and positioner members 72 may be machined from a single piece, such as, for example, by removing the center portion down to the surface 73 followed by cutting out thin strips of metal (e.g., Nitinol or Elgiloy®) to form the positioner members 72. As shown in FIGS. 7C and 7D, a unitary positioner assembly 70B can be provided by cutting a generally tubular stock 70A to provide for the positioner members 72 and a central lumen.
A number of positioner member 72 shape embodiments are possible consistent with the two functions performed by the structures. For example, FIG. 7A illustrates positioner members 72 with different radiuses of curvature over their length and which do not bend through a full 180 degrees. This embodiment places the positioner members 72 under less strain when they are collapsed around a filter 1 in the delivery configuration, illustrated in FIG. 11, and thus may be well suited for positioner members 72 made from spring materials such as stainless steel or Elgiloy®.
The filter positioning assembly 70 may include other features to facilitate delivery of a filter into a blood vessel. For example, FIG. 10 illustrates an embodiment that features an extension wire 79 projecting from the hub 71 along the longitudinal axis of the assembly for a length L3. Referring to FIG. 2, length L3 is the length of the anchor members 30 from the filter hub 2. Thus, in this embodiment of the filter positioning assembly 70, the extension wire 79 will reach up to the base of the filter hub 2. Using a relatively stiff material for the extension wire 79, the member can transfer the pushing force directly from the push rod 60 to the filter hub 2. This embodiment reduces the longitudinal force of pushing the filter 1 through the delivery catheter 16 that must be resisted by the anchor members 30. While the extension wire 79 is shown for pushing the filter during deployment, an alternative embodiment can be provided where the positioner members 72 can be used to push on the filter hub 2 while the anchor members 30 are restrained between a splined hub and the catheter. Details of the splined hub and catheter to restrain the anchor members of the filter are shown and described in PCT International Application No. PCT/US06/17890, entitled “Embolus Blood Clot Filter and Delivery System,” filed on May 9, 2006, which is hereby incorporated by reference in its entirety.
In overview, the blood filter delivery system 100 includes a storage tube 15 containing the filter 1, a catheter introducer 16 (“catheter introducer” here refers to a particular embodiment of the delivery catheter 16 so the same designation reference is used) and the push rod assembly 60 for pushing the filter 1 from the storage tube 15, through the catheter introducer 16 and then into the blood vessel, as well as supporting adapters illustrated in FIG. 21. The blood filter delivery system 100 for a blood filter device extends along a longitudinal axis A-A. Components of the system include an adapter 10, such as the Touhy-Borst Adapter shown in FIG. 29, a filter storage tube 15 (FIG. 12 and 30) that can be coupled to the Touhy-Borst Adapter 10 with a filter 1 stored in the storage tube 15 along with one of the various embodiments of the filter positioning assembly 70 that can be used to deploy the filter 1 in a blood vessel of a patient. Other components that may be used with the system include a catheter introducer 16, shown in FIG. 22, and a catheter dilator 18, shown in FIG. 25. Each system component is described in further detail below.
In various embodiments, the introducer sheath member 16 a may be formed from a range of biocompatible flexible materials, such as polyurethane, polyethylene, polyamide, polyether block amide (PEBA), nylon, and combinations thereof, preferably from a combination of PEBA 70D with PEBA 55D proximate the tip 16 a 1. The introducer sheath member 16 a may be connected to the introducer body 16 c by a bio-compatible adhesive, e.g., cyanoacrylates. In an embodiment, the distal tip 16 a 1 of the introducer sheath member 16 a can be provided with a suitable radio-opaque marker 160, or include radio-opaque marker substances within the material of the introducer tip 16 a 1. Preferably, a tantalum radio-opaque marker is formed on or near the tip 16 a 1 of the introducer sheath 16 a.
In a preferred embodiment, the introducer sheath 16 a has an outside diameter of less than about No. 10 French and an inside diameter of less than about No. 9 French and more preferably, an outside diameter of about No. 9 French or less and an inside diameter of about No. 7 French or less, depending upon limits imposed by the diameter of the blood filter in the pre-deployed (i.e., folded) configuration.
The use of complementary snap-fittings for the storage tube 15 and introducer body 16 c along with the internal and external tapers 16 f and 15 c are believed to allow for precise coupling of these two components without having to align the storage tube with the body 16 c and threading the two components together, which under some circumstances could result in cross-threading or interference with the tip of the filter 1 into the introducer sheath 16 a.
Alternative embodiments of the introducer 16 may provide additional capabilities for delivering and inspecting a blood filter. In one embodiment, an ultrasound imaging transducer is included in or near the distal end 16 a 1 positioned to be capable of imaging the deploying and deployed filter using ultrasound-imaging technology. An example of a suitable ultrasound transducer technology is disclosed in U.S. Pat. No. 5,325,860, which is incorporated by reference herein in its entirety. By incorporating an ultrasound imager within the introducer 16, a clinician can visually confirm the placement, deployment and emplacement of the filter 1 before removing the introducer 16 while minimizing the use of fluoroscopy. In an alternative embodiment, an ultrasound imaging transducer may be passed through the introducer 16 after the push rod assembly 60 has been withdrawn following delivery of the filter 1. This embodiment allows the clinician to image the implanted filter before removing the introducer 16 from the vicinity of the filter.
Referring to FIG. 30, the storage tube 15 is provided with a suitable fitting (e.g., threaded, snap or luer fitting) at both ends. In an embodiment, the storage tube 15 has a threaded fitting 15 b at one end to connect with the Touhy-Borst Adapter 10 and a snap fitting 15 a at the other end to connect with the introducer 16, as well as a taper section 15 c for insertion into the preferably triple arcuate sectioned elastomeric seal 16 e.
The example filter delivery system may be used as follows for implanting a blood filter into a host. At the start, a suitable femoral venous vessel site in the host may be selected. Typically, this is the femoral vein on either the left or right side, depending upon the patient's size or anatomy, the clinician's preference and/or the location of a venous thrombosis. The site may be nicked with a blade and the vein punctured with a suitable entry needle, such as an 18-gauge needle, or trocar. A suitable guide wire, such as a J-tipped guide wire, is inserted into the needle and advanced into a distal vena cava or iliac vessel where a filter is to be delivered. Once the guide wire is in position, the entry needle is removed from the patient and slipped off the proximal end of the guide wire. Then the proximal end of the guide wire is inserted into the introducer distal tip 16 a 1 of the introducer 16. Saline or a suitable bio-compatible fluid is provided to the introducer valve 16 d to remove air in the introducer 16, and then introducer tip 16 a 1 (and preferably both the introducer and dilator) is inserted into the patient and advanced along the guide wire until it reaches the desired position in the vena cava or iliac vessel. Positioning of the introducer tip 16 a 1 within the vein at the site for delivering the filter may be confirmed by fluoroscopy, aided by the radio-opaque markers on or within the introducer 16. The dilator tube 18 b is then inserted through the introducer body 16 c until the dilator hub 18 a is snap-fitted onto the coupling port 16 b of the introducer 16. Contrasting agent or dye may also be provided to the ports 18 d of the dilator tube 18 b via the dilator body 18 a to provide for visual imaging of the introducer tip 16 a 1 via suitable fluoroscopic imaging equipment. The guide wire and the dilator 18 can be removed once the user or physician has determined that the introducer tip 16 a 1 is at the desired location in the vein or vessel.
1. A blood filter and delivery apparatus for delivering a blood filter into a blood vessel, the vessel having a wall and a centerline, the apparatus comprising:
a) a blood filter including a plurality of filter members, a proximal filter end, and a distal filter end
b) a catheter having proximal and distal ends, the distal end being a free end portion with an opening, the catheter having a catheter wall with an inner surface surrounding a catheter lumen;
c) a filter positioning assembly situated with the filter within the catheter lumen to define a stored position, the filter positioning assembly including a plurality of positioner members, each of the plurality of positioner members having a distal end that is connected to one or more filter members of the filter within the catheter lumen in said stored position;
d) wherein in said stored position, the filter is positioned closer to the filter opening than the positioning assembly;
e) a pusher that engages the positioning assembly and filter inside the lumen in said stored position, wherein the positioning assembly and filter are movable from said stored position within the catheter lumen, to a preliminary dispensed position, and to a fully deployed position;
f) wherein in said preliminary dispensed position, some of the filter members and some of the positioning members engage the vessel wall while at least a portion of some of the filter members remain inside the catheter lumen; and
g) wherein in said fully deployed position all the filter members of the filter are deployed in the vessel by at least partially retracting the plurality of positioner members with the catheter.
2. The blood filter delivery apparatus of claim 1, further comprising a hub coupled to the plurality of positioner members, said hub defining the filter distal end, the positioner members being in between the hub and the catheter open end in the stored position.
4. The blood filter delivery apparatus of claim 2, wherein the hub includes at least one spline configured to retain the plurality of filter members.
6. The blood filter delivery apparatus of claim 2, wherein the hub has a central hub lumen.
7. The blood filter delivery apparatus of claim 1, wherein in the preliminary dispensed position the plurality of positioner members are configured to extend radially to define a catheter centerline as the filter positioning assembly and a portion of the filter exit an end of the catheter and wherein the plurality of positioner members press against a wall of the blood vessel.
8. The blood filter delivery apparatus of claim 7, wherein the positioner members locate the end of the catheter substantially along the catheter centerline so as to further locate the end of the catheter centrally within the blood vessel.
9. The blood filter delivery apparatus of claim 4, wherein in an installed position the plurality of filter members are unconstrained by the catheter after the end of the catheter is positioned substantially along the centerline.
10. The blood filter delivery apparatus of claim 1, wherein the plurality of positioner members are of a Nitinol material.
11. The blood filter delivery apparatus of claim 1, wherein the filter positioning assembly has a longitudinal axis, and further comprises an extension wire oriented along the longitudinal axis and configured to contact a hub of the filter when the plurality of filter members are retained by the plurality of positioner members.
12. The blood filter delivery apparatus of claim 1, wherein the pusher includes an elongated push rod coupled to the filter positioning assembly.
15. The blood filter delivery apparatus of claim 14, wherein the at least one-positioner member has a cross section at the proximal end greater than the cross section at the distal end.
16. The blood filter delivery apparatus of claim 14, wherein the at least one positioner member has a cross section at the proximal end less than the cross section at the distal end.
18. A blood filter and delivery assembly for delivering a blood filter to a blood vessel having a blood vessel wall, comprising:
a) a storage tube having proximal and distal end portions, a tube bore, and a distal open end at said distal end portion;
b) a blood filter having a filter proximal and a filter distal end and positioned within the storage tube bore to provide a storage position wherein the filter distal end is closer than the filter proximal end to the storage tube distal open end, the blood filter including a plurality of filter members having free end portions that are positioned proximally in said storage position;
c) a filter positioning assembly positioned within the storage tube bore in said storage position, the filter positioning assembly including a plurality of positioner members that extend distally and connect to the free end portions of the plurality of filter members in said storage position that places the filter closer to the distal open end and the positioning assembly farther from the distal open end relative to said filter;
d) a pusher that engages and pushes the connected positioner assembly and filter from the lumen toward the vessel via the distal open end into a preliminary dispensed position, and into a fully deployed position;
e) wherein in said preliminary dispensed position, the positioner members engage the vessel wall while at least a portion of some of the filter members appendages remain in the tube bore; and
f) wherein in said fully deployed position all the filter members of the filter are deployed in the vessel by at least partially retracting the plurality of positioner members with the catheter.
19. The blood filter delivery apparatus of claim 18, wherein the pusher includes an elongated push rod coupled to the filter positioning assembly.
20. A push rod assembly for use in delivering a filter into a blood vessel, the vessel having a wall, the assembly comprising:
a) a catheter having a catheter bore and a distal open end;
b) a blood filter having proximal and distal filter ends and a plurality of anchor members having anchor end portions at said proximal filter end;
c) a push rod extending along a longitudinal axis from a first end to a second end;
d) a handle disposed proximate the first end;
e) a filter positioning assembly disposed at the second end, the filter positioning assembly having a longitudinal axis and including:
a plurality of positioner members coupled to the hub, each positioner member having a positioner end extending distally, wherein each of the plurality of positioner members is curved and oriented so that the positioner members extend away from the longitudinal axis when unconstrained, and the positioner members are configured to extend toward the longitudinal axis so that the positioner members connect to and retain the plurality of anchor members when the positioner members and blood filter are positioned within the catheter in a storage position;
f) the anchor end portions being the most proximate portion of the filter;
g) the positioner ends being the most distal portion of the filter positioning assembly;
h) wherein the filter and positioner members are movable to a preliminary dispensed position and to a fully deployed position;
i) wherein in said preliminary dispensed position, the positioner ends engage the vessel wall, wherein at least a portion of some of the anchor members remain in the catheter bore proximally of said catheter distal open end; and
j) wherein in said fully deployed position all the filter members of the filter are deployed in the vessel by at least partially retracting the plurality of positioner members with the catheter.
23. The push rod assembly of claim 20, further comprising an extension wire oriented along the longitudinal axis and configured to contact a hub of the filter when the plurality of anchor members are retained by the plurality of positioner members.
29. A blood filter delivery apparatus for delivering a blood filter into a blood vessel, the vessel having a wall, the apparatus comprising:
a) a blood filter including a plurality of anchor members and having proximal and distal end portions;
b) a catheter having proximal and distal ends, a bore, and a distal catheter opening at the distal end of the catheter;
c) a filter positioning assembly situated within the catheter bore, the filter positioning assembly including a plurality of positioner members, each having a positioner distal end and a hub defining a plurality of splines, each of the splines being configured to cooperate with and retain the plurality of anchor members within the catheter when the ends of the positioner members are the most distal portion of the positioning assembly disposed within the catheter;
d) wherein the anchor members have proximal free ends that are the most proximal portion of the blood filter;
e) wherein in an initial, partially dispensed position the distal ends of the positioner members engage the vessel wall while at least a portion of some of the anchor members are located in the catheter bore proximally of said distal catheter opening; and
f) wherein in a fully deployed position all the filter members of the filter are deployed in the vessel by at least partially retracting the plurality of positioner members with the catheter.
US12/096,783 2005-12-30 2006-12-29 Embolus blood clot filter delivery system Active 2031-08-08 US8734479B2 (en)
PCT/US2006/062725 A-371-Of-International WO2007079410A2 (en) 2005-12-30 2006-12-29 Embolus blood clot filter delivery system
US20090318951A1 US20090318951A1 (en) 2009-12-24
US8734479B2 true US8734479B2 (en) 2014-05-27
US12/096,783 Active 2031-08-08 US8734479B2 (en) 2005-12-30 2006-12-29 Embolus blood clot filter delivery system
US14/248,859 Active 2027-04-21 US9421081B2 (en) 2005-12-30 2014-04-09 Embolus blood clot filter delivery system
US15/219,015 Active 2027-01-27 US10188498B2 (en) 2005-12-30 2016-07-25 Embolus blood clot filter delivery system
US16/213,283 Pending US20190167405A1 (en) 2005-12-30 2018-12-07 Embolus blood clot filter delivery system
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