Source: http://www.docstoc.com/docs/96884020/Embolic-Protection-System---Patent-7972352
Timestamp: 2014-08-01 12:49:02
Document Index: 343848659

Matched Legal Cases: ['Application No. 970789', 'Application No. 980267', 'Application No. 2001', 'Application No. 2001', 'Application No. 2001', 'Application No. 2001']

Embolic Protection System - Patent 7972352
United States Patent: 7972352
7,972,352
An embolic protection system having a guidewire for advancing through a
vasculature; an embolic protection filter having a filter body with a
distal end and a proximal end, the filter body providing for a collapsed
configuration and an expanded deployed configuration. The embolic
protection filter body has a guidewire path for slidably receiving the
guidewire to permit movement of the filter relative to the guidewire when
the filter 1 is in the collapsed configuration and the expanded deployed
configuration. A delivery catheter is advanceable over the guidewire for
delivery of the embolic protection filter. A retrieval catheter is also
advanceable over the guidewire for retrieval of the filter , and
engagement elements are used for engaging the embolic protection filter
with the guidewire for retrieval of the filter into the retrieval
catheter in the collapsed configuration.
Gilson; Paul (Moycullen, IE), Taylor; Charles (Warninglid, GB), Grirrin; Patrick (Castlegar, IE), Nielan; John (Gort, IE), Vale; David (Clontarf, IE), Brady; Eamon (Elphin, IE)
10/980,865
10396716Mar., 2003
Kuleika et al.
Esksuri et al.
A. Beck et al., &quot;Dilatation of the Carotid Artery by a Temporary Carotid Filter&quot;, Edizioni Oplitai--Via dei Foscari N.degree. 7 -00162 Roma, Spediz, in Abb. Postale Gruppo IV--70%--Anno II N. 6 Nov.-Dec. 1989 L. 800. cited by other
10/396,716, filed Mar. 26, 2003 now abandoned, which is a continuation of
U.S. application Ser. No. 09/838,545, filed Apr. 20, 2001 now abandoned,
which is a continuation-in-part of U.S. application Ser. No. 09/188,472,
filed Nov. 9, 1998, now U.S. Pat. No. 6,336,934, which claims priority
from Irish Patent Application No. 970789 filed on Nov. 7, 1997 and Irish
Patent Application No. 980267 filed on Apr. 8, 1998; International
Application No. PCT/IE00/00045 filed on Apr. 20, 2000; Irish Patent
Application No. 2001/0255 filed on Mar. 16, 2001; Irish Patent
Application No. 2001/0256 filed on Mar. 16, 2001; Irish Patent
Application No. 2001/0259 filed on Mar. 16, 2001; and Irish Patent
Application No. 2001/0263 filed on Mar. 16, 2001; all of which are hereby
1.  An embolic protection system comprising: a guidewire for advancing through a vasculature, the guidewire having a distal end and a proximal end;  an embolic
protection filter having a filter body with a distal end and a proximal end, the filter body providing for a collapsed configuration and an expanded deployed configuration;  the embolic protection filter body having a guidewire path for slidably
receiving the guidewire to permit movement of the filter relative to the guidewire when the filter is in the collapsed configuration and the expanded deployed configuration;  a delivery catheter advanceable over the guidewire for delivery of the embolic
protection filter;  the delivery catheter having a proximal end and a distal end, the filter being deployed from the distal end of the delivery catheter into the expanded deployed configuration;  and engagement elements for engaging the embolic
protection filter with the guidewire, wherein the engagement elements comprise a guidewire engagement element slidably disposed on the guidewire and a filter engagement element fixed to the filter, the engagement elements co-operating to provide
selective engagement and positioning of the filter with respect to the guidewire, the guidewire engagement element comprising a releasble tapered locking ring slidably disposed on the guidewire, the releasable tapered locking ring having a tapered
surface on the outside thereof and the filter engagement element comprising an inner tapered surface, the inner tapered surface of the filter engagement element engageable with the outer tapered surface of the releasable tapered locking ring, thereby
causing the releasable tapered locking ring to frictionally engage the guidewire to selectively lock the filter to the guidewire.
2.  An embolic protection system as claimed in claim 1 wherein the guidewire path is in isolation from the embolic material captured within the filter body.
3.  An embolic protection system as claimed in claim 1 wherein the guidewire path is further defined by a tubular sleeve.
4.  An embolic protection system as claimed in claim 3 wherein the tubular sleeve extends from the proximal end to the distal end of the filter.
5.  An embolic protection system as claimed in claim 3, wherein the filter engagement element is provided by the tubular sleeve.
6.  An embolic protection system as claimed in claim 1 wherein the guidewire path is a tubular guidewire path.
7.  An embolic protection system as claimed in claim 1, wherein the locking ring is located at the distal end of the guidewire.
8.  An embolic protection system as claimed in claim 1 wherein the locking ring is located proximal of the distal end of the guidewire.
9.  An embolic protection system as claimed in claim 1, including a tube advanceable over the guidewire, the locking ring being located between a distal end of the tube and the filter for retrieval of the filter.
10.  An embolic protection system as claimed in claim 1, further comprising a tether engagable with the filter for retrieving the filter into a retrieval catheter.
11.  An embolic protection system as claimed in claim 1 comprising deployment means for moving the collapsed filter relative to the distal end of the delivery catheter.  Description
According to the invention there is provided an embolic protection system comprising: a guidewire for advancing through a vasculature, the guidewire having a distal end and a proximal end; an embolic protection filter having a filter body with a
distal end and a proximal end, the filter body providing for a collapsed configuration and an expanded deployed configuration; the embolic protection filter body having a guidewire path for slidably receiving the guidewire to permit movement of the
In another aspect the invention provides a method for the capture and removal of embolic material from a blood vessel during an interventional procedure comprising the steps of: advancing a guidewire through a vasculature; crossing a desired
In a further embodiment the method includes the steps of: loading the filter in a collapsed configuration within a delivery catheter; advancing the delivery catheter and filter over the guidewire to deliver the filter to a desired location; and
Preferably the method includes the steps of: collapsing the filter from an expanded configuration for loading the filter into the delivery catheter; the filter being expanded to a deployment configuration on release from the delivery catheter.
According to another aspect of the invention there is provided a medical catheter for transvascular delivery and deployment of an embolic protection filter, the catheter comprising: an outer catheter tube defining a distal end; and an inner
According to the invention there is also provided an assembly for loading a collapsible embolic protection filter into a catheter, the assembly comprising: a catheter defining a reception space at a distal end of the catheter for receiving a
In a further aspect of the invention there is provided a method of loading an embolic protection filter into a catheter, the method comprising the steps of: providing an embolic protection filter, the embolic protection device being collapsible;
providing a embolic protection catheter defining a reception space at a distal end of the catheter for receiving the collapsed embolic protection filter; providing a pushing device for delivering the embolic protection filter into the reception space;
delivering the embolic protection filter into the reception space using the pushing device; and removing the pushing device from the reception space.
In another aspect the invention provides a method of loading an embolic protection filter into a catheter, the method comprising the steps of: providing a embolic protection filter, the embolic protection filter being collapsible; providing a
In one embodiment the method comprises the steps of: providing a pushing device for delivering the embolic protection filter through the loading device and into the reception space, and for engaging the collapsed embolic protection filter with
8 is used to push the embolic protection device 1 through the loading device 7 and into the pod 13 of the delivery catheter 2 in the collapsed configuration.  The delivery catheter 2 is now ready for advancement over the guidewire 99.
within the wall 22 of the catheter which may be a polymeric material (detailed in FIG. 4A is a polyimide wall).  These wires/fibers provide the outer shaft with high tensile modulus (minimal stretch)which results in a shaft that can not store much strain
energy.  The inclusion of the above high tensile elements 21 allows for a low profile outer shaft 2.  This low wall thickness outer catheter shaft therefore also has low flexural stiffness, good flexibility, trackability and subsequently low insertion
force.  The inner surface 23 of the lumen of this shaft 2 is a low friction (PTFE) material to minimise the friction strain energy incurred during the deployment action.
high compression modulus steel wire braid 24 contained within a polymeric matrix 24A.  The inner lumen of the shaft 25 is made of a low friction (PTFE) material layer 24B.  The outer surface of the shaft 25 is also provided with a low friction (FEP)
material layer 24C.  The layers 24B and 24C minimise the frictional strain energy incurred during delivery and deployment.  Due to the combination of the above inner and outer shaft 2,25 the amount of strain energy that can be stored within the system
profile.  In this case, the guide olive 57 is integral with the filter body 41 and is of the material Pellethane.  As illustrated in FIGS. 18 and 19, the guide olive 57 extends distally of the distal end 49 of the sleeve 43.
Two gold marker bands 59, 60 are provided mounted to the sleeve 43.  One marker band 59 is fixedly attached to the olive 51 and one marker band 60 is fixedly attached to the proximal end 45 of the frame 42.  The marker bands 59, 60 assist in
As illustrated in FIG. 21 the distal stop 72 is provided by an end 74 of an outer hypotube 73 which extends from the handle 70 partially along the wire 71.  The free end 74 of the hypotube 73 forms a step from the small diameter wire.  71
proximal of the step to the larger diameter hypotube 73 distal of the step.  The small diameter is preferably approximately 0.014&#39;&#39; (0.3556 mm), and the large diameter is preferably approximately 0.018&#39;&#39; (0.4572 mm).  The hypotube 73 may be attached to
the wire 71 by any suitable means, such as an adhesive means, or a mechanical keying means, or by brazing, or soldering, or welding, or by any other suitable means.
tray 5, as illustrated in FIGS. 28 and 29.  In this configuration the pushing device is still retained to the tray (FIG. 29A).The pushing device 8 is now free to slide proximally in the channel 6 (FIG. 30), until the distal stop 72 engages with the
collapsing the filter element 40 from the extended outwardly projecting position of FIG. 31(a) to the collapsed position of FIG. 32(a), and into the pod 13 of the delivery catheter 2 (FIG. 32(a)) until the filter element 40 abuts the distal end 27 of the
In this case, the guidewire 99 is partially of stainless steel, and partially of a radiopoque material to aid the user in positioning the guidewire 99 accurately in a vasculature.  The guidewire 99 has a coating of a low friction material, for
example of a fluoropolymer such as polytetrafluoroethylene, or of a silicone material, or of a hydrophilic material, for ease of advancement of the guidewire 99 through a vasculature and ease of exchange of the filter element 40 and /or other medical
111, or an angioplasty balloon 112 to carry out an angioplasty procedure on the stenosed region 111, as illustrated in FIG. 42, or a stent 113 to carry out a stenting procedure on the stenosed region 11, as illustrated in FIG. 43, or any possible
an elongate tubular centring catheter 121.  The centring catheter 121 has a tapered distal tip 122 which protrudes distally of a distal end 120 of the retrieval catheter 3 during advancement through the vasculature 110, as illustrated in FIG. 44, to
distally over the guidewire 99 while maintaining the position of the centring catheter 121 until the distal end 120 of the retrieval catheter 3 is immediately proximal of the deployed filter element 40.  The guidewire 99 is retracted to engage the distal
stop 101 with the distal end 49 of the sleeve 43 of the filter element 40.
The guidewire 99 may be left in place in the vasculature 110 after the retrieval catheter 3, the centring catheter 121, and the retrieval filter element 40 have been withdrawn from the vasculature 110, as illustrated in FIG. 47.  Alternatively
the guidewire 1 may be withdrawn from the vasculature 110 upon withdrawal of the retrieval catheter 3, the centring catheter 121, and the retrieval filter element 40.
110.  The position of the bare guidewire 99 may be adjusted proximally or distally, as desired, to suit a further treatment or diagnostic procedure.  Otherwise a fluroscopic assessment of the treated vessel may be made through the guiding catheter or
distally relative to the guidewire 160 is possible, and thus facilitates retrieval of the embolic protection device into the retrieval catheter 3.  The retrieved embolic protection device is then withdrawn from the vasculature 110 by withdrawing the
Embolic protection system, Gilson, et al., Paul Gilson, Charles Taylor, Patrick Grirrin, John Nielan, David Vale, Eamon Brady, Application number 10 980-865, Surgery
INTRODUCTION This invention relates to a transvascular embolic protection system for safely capturing and retaining embolic material released during an interventional procedure while maintaining blood flow. WO-A-99/23976 describes various embolic protection systems of this type. WO-A-99/51167 and WO-A-99/51166 describe delivery catheters for delivery of an embolic protection filter to a desired site in the vascular system. Various embolic filtersare described in WO-A-00/67668), WO-A-00/67669 WO-A-00/67670 and WO-A-00/67671. A retrieval catheter for use with such embolic protection systems is described in WO-A-01/12082. There is an economical and clinical need to provide an improved embolic protection system which will be easy and convenient for a clinician to prepare for use, to deploy and to retrieve. In addition there is a need to provide such a systemwhich will facilitate a wide range of clinical procedures to be carried out.STATEMENTS OF INVENTION According to the invention there is provided an embolic protection system comprising: a guidewire for advancing through a vasculature, the guidewire having a distal end and a proximal end; an embolic protection filter having a filter body with adistal end and a proximal end, the filter body providing for a collapsed configuration and an expanded deployed configuration; the embolic protection filter body having a guidewire path for slidably receiving the guidewire to permit movement of thefilter relative to the guidewire when the filter is in the collapsed configuration and the expanded deployed configuration; a delivery catheter advanceable over the guidewire for delivery of the embolic protection filter; the delivery catheter having aproximal end and a distal end, the filter being deployed from the distal end of the delivery catheter into the expanded deployed configuration; a retrieval catheter advanceable over the guidewire for retrieval of the filter, the retrieval catheter havinga distal end and a proximal end