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United States Patent

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United States Patent 6,997,939
Linder ,   et al. February 14, 2006
Methods, systems, and devices for deploying an embolic protection filter


Abstract

A filter device is adapted to function as a guidewire, an exchange guidewire, and provide embolic protection during a procedure. The filter device includes a filter assembly that is either integral with or coupled to a guide member. The filter assembly includes a plurality of struts that expand outwardly to deploy a filter that collects or captures material flowing along the blood vessel within which the filter device is deployed. The plurality of struts are constrained by a restraining member or mechanism that prevents the plurality of struts from expanding or extending outwardly to deploy the filter. Cooperating with the restraining member or mechanism is an actuating assembly that is adapted to release the restraining member or mechanism and enable the filter to be deployed from the guide member. A capture catheter is cooperates with the filter device and substantially surrounds the filter during removal of the filter device.

Inventors: Linder; Richard J. (Sandy, UT); Edmiston; Daryl R. (Sandy, UT); Johnson; Steven W. (West Jordan, UT)
Assignee: Rubicon Medical, Inc. (Salt Lake City, UT)
Appl. No.: 186292
Filed: June 28, 2002

Current U.S. Class: 606/200
Current International Class: A61M 29/00 (20060101)
Field of Search: 606/191,192,194,195,198,200,159 623/1.12,1.23

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Primary Examiner: Milano; Michael J.
Assistant Examiner: Baxter; Jessica R.
Attorney, Agent or Firm: Crompton, Seager & Tufte LLC
Parent Case Text


CROSS-REFERENCE TO RELATED APPLICATIONS

This patent application claims priority to U.S. Provisional Patent Application Ser. No. 60/302,417, filed Jul. 2, 2001, U.S. Provisional Patent Application Ser. No. 60/345,333, filed Nov. 9, 2001, U.S. Provisional Patent Application Ser. No. 60/347,500, filed Jan. 11, 2002 and U.S. Provisional Patent Application Ser. No. 60/341,092, filed Dec. 12, 2001, the disclosures of which are herein incorporated by this reference.

Additionally, this patent application incorporates by reference the disclosure of co-pending patent applications entitled "Methods, Systems, and Devices for Providing Embolic Protection and Removing Embolic Material," U.S. patent application Ser. No. 10/186,275, "Methods, Systems, and Devices for Providing Embolic Protection," U.S. patent application Ser. No. 10/186,304, and "Methods, Systems, and Devices for Deploying a Filter from a Filter Device," U.S. patent application Ser. No. 10/186,255.
Claims


What is claimed is:

1. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device, the restraining mechanism comprising: (a) a sleeve disposable substantially at a distal end of the filter device, said sleeve being attached to least one of the plurality of struts of the filter and applies a restraining force to the plurality of struts of the filter device to prevent the plurality of struts from extending outwardly; and (b) at least one actuating member at least partially interwoven with said sleeve, said at least one actuating member releasing said restraining force of said sleeve so that the plurality of struts of the filter device extend outwardly as said at least one actuating member is moved in a proximal direction.

2. A restraining mechanism as recited in claim 1, wherein said at least one actuating member is adapted to cause said sleeve to move in a proximal direction upon moving said at least one actuating member in said proximal direction.

3. A restraining mechanism as recited in claim 1, wherein said sleeve is coupled to at least two of said plurality of struts.

4. A restraining mechanism as recited in claim 1, wherein said sleeve comprises at least one preferential separation region.

5. A restraining mechanism as recited in claim 4, wherein said at least one actuating member cooperates with said at least one preferential separation region and is adapted to preferentially separate said sleeve at said at least one preferential separation region.

6. A restraining mechanism as recited in claim 1, wherein said sleeve includes a plurality of apertures adapted to receive a securing member.

7. A restraining mechanism as recited in claim 1, wherein said sleeve comprises a first end and a second end, each of said first end and said second end comprising one or more of said plurality of apertures.

8. A restraining mechanism as recited in claim 7, wherein said apertures in said first end and second end alternately receive said securing member to apply said restraining force against the plurality of struts.

9. A restraining mechanism as recited in claim 8, wherein said securing member is adapted to be removed from said plurality of apertures to allow said plurality of struts to extend outwardly.

10. A restraining mechanism as recited in claim 1, wherein said actuating member is stitched through said sleeve.

11. A restraining mechanism as recited in claim 1, wherein said sleeve comprises a first end and a second end, each of said first end and said second end comprising a plurality of extensions.

12. A restraining mechanism as recited in claim 11, wherein one or more extensions of said plurality of extensions on said first end are offset from one or more extensions of said plurality of extensions on said second end.

13. A restraining mechanism as recited in claim 11, wherein each of said plurality of extensions are folded to form an channel through which said at least one actuating member is disposed to apply the restraining force against the plurality of struts.

14. A restraining mechanism as recited in claim 1, wherein said sleeve further comprises a plurality of hoops, each of said plurality of hoops being adapted to receive said at least one actuating member.

15. A filter device as recited in claim 1, wherein said sleeve comprises a first portion and a second portion, said first portion and said second portion being maintained substantially together by stitching said at least one actuating member through said sleeve substantially at said first portion and said second portion.

16. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device, the restraining mechanism comprising: (a) means for applying a restraining force to the plurality of struts of the filter device to prevent the plurality of struts from extending outwardly, said means for apply the restraining force being attached to at least one of the plurality of struts of the filter; and (b) at least one actuating member at least partially interwoven with said means for applying the restraining force, said at least one actuating member releasing said restraining force of said means for applying said restraining force and enabling the plurality of struts of the filter device to extend outwardly to deploy the filter as said at least one actuating member moves in a proximal direction.

17. A restraining mechanism as recited in claim 16, wherein said means for applying the restraining force comprises a sleeve attached to each of said plurality of struts, said sleeve comprising at least one preferential separation region.

18. A restraining mechanism as recited in claim 17, wherein said at least one actuating member cooperates with said at least one preferential separation region, said at least one actuating member being adapted to cause said means for applying the restraining force to preferentially separate at said at least one preferential separation region.

19. A restraining mechanism as recited in claim 17, wherein said preferential separation region dissolves based upon a chemical reaction between a material forming said means for applying the restraining force and a fluid within a body lumen.

20. A restraining mechanism as recited in claim 17, wherein said preferential separation region separates under the influence of at least one of heat, ultrasonic energy, or radio frequency energy.

21. A restraining mechanism as recited in claim 16, wherein said means for applying said restraining force comprises a plurality of hoops formed by a sleeve of said means for applying the restraining force, each of said plurality of hoops being adapted to receive said at least one actuating member.

22. A restraining mechanism as recited in claim 16, wherein said means for applying the restraining force comprises a sleeve having a first portion and a second portion, said first and second portions being maintained substantially together by stitching said at least one actuating member through said sleeve substantially at said first portion and said second portion.

23. A restraining mechanism as recited in claim 22, wherein said sleeve comprises a first side and a second side, each side comprises a plurality of extensions.

24. A restraining mechanism as recited in claim 16, wherein said means for applying the restraining force comprises a first side and a second side, each side comprises a plurality of extensions.

25. A restraining mechanism as recited in claim 24, wherein one or more extensions of said plurality of extensions on said first end are offset from one or more extensions of said plurality of extensions on said second end.

26. A restraining mechanism as recited in claim 25, wherein each of said plurality of extensions being folded to form a channel through which said at least one actuating member is disposed to cause said sleeve to prevent said plurality of struts extending outwardly.

27. A restraining mechanism as recited in claim 16, wherein said means for applying the restraining force comprises a sleeve substantially surround the plurality of struts.

28. A restraining mechanism as recited in claim 27, wherein said sleeve is adapted to slide in a proximal direction upon moving said actuating member in the proximal direction.

29. A restraining mechanism as recited in claim 28, wherein said sleeve is a polymer sleeve.

30. A restraining mechanism as recited in claim 28, wherein said sleeve is a metallic sleeve.

31. A restraining mechanism as recited in claim 16, wherein said means for applying said restraining force comprises a plurality of tubular members attached to the plurality of struts of the filter.

32. A restraining mechanism as recited in claim 31, wherein said plurality of tubular members receive said at least one actuating member with respective lumens of said plurality of tubular members, the at least one actuating member preventing movement of adjacent tubular members of said plurality of tubular member to prevent the plurality of struts extending outwardly to deploy said filter.

33. A system as recited in claim 16, wherein said means for applying said restraining force comprises at least one flap formed in the filter, said flap being adapted to substantially surround the plurality of struts and prevent the plurality of struts extending outwardly to deploy said filter.

34. A method for releasing a plurality of struts of a filter device during a procedure, comprising: (a) positioning a filter device in a vasculature of a patient, distal of a portion of a blood vessel to be accessed during a procedure, to collect emboli, the filter device comprising: (i) a guide member comprising a distal end; (ii) a plurality of struts cooperating with said distal end of said guide member; (iii) a filter coupled to said guide member; and (iv) a restraining member attached to at least one of said plurality of struts to prevent said plurality of struts from extending outwardly; and (b) actuating an actuating member at least partially interwoven through at least a portion of said restraining member, wherein actuating said actuating member in a proximal direction releases said plurality of struts to deploy said filter, wherein following collecting emboli, said filter device and said actuating member are removed from the blood vessel.

35. The method as recited in claim 34, wherein actuating said actuating member comprises moving said actuating member in a proximal direction.

36. The method as recited in claim 34, wherein actuating said actuating member further comprises moving said actuating member in a proximal direction to remove said actuating member from cooperating with said restraining member.

37. The method as recited in claim 36, wherein said actuating member is stitched into said restraining member.

38. The method as recited in claim 36, wherein said restraining member further comprises one or more apertures and said actuating member cooperates with said one or more apertures to prevent said plurality of struts from extending outwardly.

39. The method as recited in claim 36, wherein said restraining member further comprises a first side with one or more extensions forming one or more first channels and a second side with one or more extensions forming one or more second channels, wherein said actuating member cooperates with said one or more first channels and said one or more second channels to prevent said plurality of struts from extending outwardly.

40. The method as recited in claim 36, wherein said restraining member further comprises one or more preferential separation regions, wherein said actuating member cooperates with said one or more preferential separation regions to prevent said plurality of struts from extending outwardly.

41. The method as recited in claim 40, wherein moving said actuating member in the proximal direction causes said actuating member to separate said restraining member at said one or more preferential separation regions.

42. The method as recited in claim 34, wherein actuating said actuating member comprises removing said actuating member from engaging with a plurality of tubular members coupled to said plurality of struts, said plurality of struts forming said restraining member.

43. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts, the restraining mechanism comprising: (a) a sleeve disposable substantially at a distal end of the filter device to surround the plurality of struts of the filter device and apply a restraining force to the plurality of struts of the filter device to prevent the plurality of struts from extending outwardly, said sleeve at least partially attached to at least one of the plurality of struts and having a proximal end, a distal end, and one or more preferential separation regions extending from said distal end toward said proximal end, and (b) at least one actuating member at least partially interwoven with said sleeve, said at least one actuating member releasing said restraining force of said sleeve so that the plurality of struts of the filter device extend outwardly as said at least one actuating member is moved in a proximal direction to preferentially separate said sleeve, while at least a portion of said sleeve remains attached to at least one of the plurality of struts of the filter device.

44. The restraining mechanism of claim 43, wherein said at least one actuating member comprises a proximal end and a distal end, said proximal end being distal to a proximal end of said sleeve.

45. The restraining mechanism of claim 44, wherein said proximal end of said at least one actuating member is disposed between said sleeve and the plurality of struts.

46. The restraining mechanism of claim 43, wherein said at least one actuating member cuts said sleeve from a distal end of said sleeve toward a proximal end of said sleeve generally parallel to a longitudinal axis of said sleeve.

47. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts the restraining mechanism comprising: (a) at least one flap formed on the filter of the filter device, said at least one flap substantially surrounding said plurality of struts to prevent said plurality of struts from moving outwardly; and (b) at least one actuating member at least partially interwoven with said at least one flap, said at least one actuating member releasing said restraining force of said at least one flap so that the plurality of struts of the filter device extend outwardly as said at least one actuating member is moved in a proximal direction.

48. The restraining mechanism of claim 47, wherein a first portion of said at least one flag is coupled to a second portion of said at least one flag by an adhesive.

49. The restraining mechanism of claim 47, wherein said at least one flap is disposed between two struts of the plurality of struts.

50. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts, the restraining mechanism comprising: (a) a sleeve disposable substantially at a distal end of the filter device to surround the plurality of struts of the filter device and apply a restraining force to the plurality of struts of the filter device to prevent the plurality of struts from extending outwardly, said sleeve at least partially attached to at least one of the plurality of struts and having a first end and a second end, said first end comprising a plurality of first tongues and said second end comprising a plurality of second tongues offset from said plurality of second tongues, said first tongues and said second tongues forming a plurality of channels, and (b) at least one actuating member disposed within said plurality of channels to maintain said plurality of first tongues and said plurality of second tongues relative one to another and prevent said plurality of struts extending outwardly to deploy the filter.

51. A restraining mechanism as recited in claim 50, wherein said at least one actuating member passes through said plurality of channels alternating between passing through a first channel of said plurality of first tongues and a second channel of said plurality of second tongues.

52. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts, the restraining mechanism comprising: (a) a plurality of tubular members, each tubular member of said plurality of tubular members having a lumen therethrough and being attached to one of the plurality of struts of the filter device; and (b) an actuating member disposed within said lumen of each tubular member of said plurality of tubular members as said lumen of each tubular member substantially align to prevent said plurality of struts extending outwardly to deploy the filter.

53. A restraining mechanism of claim 52, wherein said actuating member moves in a proximal direction to be removed from said lumen of each tubular member.

54. A restraining mechanism of claim 52, wherein each said tubular member is disposed upon an interior surface of each strut of said plurality of struts of the filter device.

55. A restraining mechanism configured to prevent a plurality of struts of a filter device from extending outwardly prior to deploying a filter of the filter device that is attached to the plurality of struts the filter device having a proximal end and a distal end, the restraining mechanism comprising: (a) a wire at least attached to and partially surrounding at least one of the plurality of struts, said wire forms a plurality of hoops having lumens therethrough, said wire forms one hoop of said plurality of hoops at a first location distant from the distal end of the filter device and at least partially surrounds the plurality of struts to form an another hoop of said plurality of struts at a second location closer to the distal end of the filter device than the first location of said one hoop; and (b) at least one actuating member disposed within said lumens of each hoop of said plurality of hoots to prevent said plurality of struts extending outwardly to deploy the filter.

56. A restraining mechanism of claim 55, wherein said at least one actuating member moves in a proximal direction to be removed from said lumen of each tubular member.
Description


BACKGROUND OF THE INVENTION

1. The Field of the Invention

The present invention relates generally to the field of percutaneous medical filters, and more specifically, to vascular filter devices that are configured for percutaneous insertion into a blood vessel of a patient.

2. The Relevant Technology

Human blood vessels often become occluded or blocked by plaque, thrombi, other deposits, or material that reduce the blood carrying capacity of the vessel. Should the blockage occur at a critical place in the circulatory system, serious and permanent injury, and even death, can occur. To prevent this, some form of medical intervention is usually performed when significant occlusion is detected.

Several procedures are now used to open these stenosed or occluded blood vessels in a patient caused by the deposit of plaque or other material on the walls of the blood vessels. Angioplasty, for example, is a widely known procedure wherein an inflatable balloon is introduced into the occluded region. The balloon is inflated, dilating the occlusion, and thereby increasing the intraluminal diameter.

Another procedure is atherectomy. During atherectomy, a catheter is inserted into a narrowed artery to remove the matter occluding or narrowing the artery, i.e., fatty material. The catheter includes a rotating blade or cutter disposed in the tip thereof. Also located at the tip are an aperture and a balloon disposed on the opposite side of the catheter tip from the aperture. As the tip is placed in close proximity to the fatty material, the balloon is inflated to force the aperture into contact with the fatty material. When the blade is rotated, portions of the fatty material are shaved off and retained within the interior lumen of the catheter. This process is repeated until a sufficient amount of fatty material is removed and substantially normal blood flow is resumed.

In another procedure, stenosis within arteries and other blood vessels is treated by permanently or temporarily introducing a stent into the stenosed region to open the lumen of the vessel. The stent typically comprises a substantially cylindrical tube or mesh sleeve made from such materials as stainless steel or nitinol. The design of the material permits the diameter of the stent to be radially expanded, while still providing sufficient rigidity such that the stent maintains its shape once it has been enlarged to a desired size.

Unfortunately, such percutaneous interventional procedures, i.e., angioplasty, atherectomy, and stenting, often dislodge material from the vessel walls. This dislodged material can enter the bloodstream, and may be large enough to occlude smaller downstream vessels, potentially blocking blood flow to tissue. The resulting ischemia poses a serious threat to the health or life of a patient if the blockage occurs in critical tissue, such as the heart, lungs, kidneys, or brain, resulting in a stroke or infarction.

In general, existing devices and technology have a number of disadvantages including high profile, difficulty using multiple parts and components that result in an involved procedure, manufacturing complexity, and complex operation of the device or system.

BRIEF SUMMARY OF THE INVENTION

Embodiments of the present invention provide systems, methods, and devices for overcoming the above-referenced problems. More specifically, embodiments of the present invention include filter devices that have small, low, or no profiles, few parts and components, and are simple to manufacture and use. Consequently, embodiments of the present invention are able to be easily inserted into a patient, be steerable through the tortuous anatomy of a patient, provide filtering capabilities, have a sufficiently low profile to provide exchange capability so other medical devices can be advanced along the filter device, and be capable of removing the captured material without allowing such material to escape during filter retrieval.

According to one aspect of one embodiment of present invention, an illustrative embodiment of the present invention includes a vascular filter device. This device includes a guide member, such as a guidewire or hypo-tube having a lumen that extends from a distal end toward a proximal end thereof. Disposed within the lumen are one or more actuating members and a filter assembly. The one or more actuating members are coupled to an actuating mechanism at the proximal end of the guide member and are configured to deploy the filter assembly during a procedure, such as through movement of one or more actuating members.

The filter assembly includes a filter and a plurality of radially spaced-apart struts connected to a peripheral edge of a proximal end of the filter. The struts expand outwardly upon being deployed from the lumen of the guide member to place the peripheral edge of the proximal end of the filter adjacent to the wall of the vessel.

The filter includes a plurality of pores or holes that are so sized to capture material that may become detached during the procedure. The proximal end of the filter is configured to be constrained against the blood vessel within which the filter is disposed, while the distal end, in one embodiment, is configured to "float" within the blood flowing through the blood vessel and change shape to collect material and maintain the flow of blood through the vessel.

In one embodiment of the present invention, the filter device includes a number of radiopaque bands and/or markers affixed to a variety of positions on the device. These radiopaque bands and/or markers are one example of means for radiopacity, with various other means for radiopacity being known to those skilled in the art.

During use of the filter device of the present invention, blood flow will cause the filter to assume a parachute-like configuration such that material is collected within the interior of the filter. To remove the filter and the material, in one embodiment, the actuating member is moved in the proximal direction so that the proximal end of the filter cooperates with the distal end of the lumen through the guide member. Upon positioning the proximal end of the filter, a capture catheter is moved or advanced along the guide member until the catheter substantially encloses the filter. Following positioning of the capture catheter, the catheter and guide member are removed from the patient.

According to another embodiment of the present invention, a guide member includes a plurality of struts disposed at the distal end of the guide member. In one configuration, the distal end of the guide member is divided into a plurality of struts, at least two of which are biased to move outwardly. In another configuration, a strut assembly is coupled to the distal end of the guide member, with the strut assembly including one or more struts attached to the filter, while formed at a distal end of a third strut is a coil tip. This third strut is optionally biased toward the center of the lumen of the guide member. Before the filter is deployed, the filter is folded about the distal end of the guide member, folded about one or more of the plurality of struts, and/or is positioned within the lumen of the guide member.

To maintain the struts in the closed position, i.e., not extending outwardly from the remaining body of the guide member, a retaining member or mechanism cooperates with the guide member and/or struts and applies a restraining force to one or more of the struts. By moving the guide member relative to the restraining member, or vice versa, the distal ends of two or more of the biased struts are allowed to move outwardly to deploy the filter, i.e., the restraining force is released.

In another configuration, the restraining member or mechanism surrounds a tip of the guide member, including the struts and a part of the guide member. This restraining member or mechanism can be attached to the struts and is configured to apply a restraining force to the one or more struts. In one configuration, the restraining member or mechanism is configured to separate into a number of different sections to allow the distal ends of two or more of the biased struts to move outwardly to deploy the filter. In another embodiment, the restraining member or mechanism includes two or more actuating members that are attached to a location just proximal to the proximal end of each strut. The two or more actuating members extend to the distal end of the guide member, pass through apertures in the distal end of the restraining member or mechanism, and terminate within the lumen of the guide member after passing through holes formed in the guide member proximal to the proximal end of each strut.

To actuate the filter device, an actuating assembly at the proximal end of the guide member draws the actuating members in the proximal direction. Since one end of the actuating member is located at the proximal end of the restraining member or mechanism, whether forming part of the restraining member or mechanism, attached to the restraining member or mechanism, or attached to the guide member, pulling the actuating member in the proximal direction causes the actuating member to preferentially separate the restraining member or mechanism, thereby releasing the strut.

In another configuration, the restraining member or mechanism includes a plurality of apertures formed therein. The restraining member or mechanism has a first portion and a second portion with one or more of the plurality of apertures formed therein. The restraining member or mechanism further includes a securing member that passes through one or more of the plurality apertures to cause the first portion to be releasably connected to the second portion. The securing member passes through an aperture in the guide member and/or a strut assembly to pass into the end of the guide member and extend toward the proximal end. Upon moving the securing member in a proximal direction using one of a variety of different actuating mechanisms, a distal end of the securing member is removed from the apertures and the first and second both portions of the restraining member or mechanism. In this manner, the force applied to the struts to maintain a closed configuration, where the struts are retained or prevented from extending outwardly, is released from the struts, enabling them to deploy the filter.

In still another configuration, the restraining member or mechanism includes a securing member that is "sewn" through portions of the restraining member. In a similar manner to the configuration discussed above, the securing member can be removed from cooperating with the restraining member or mechanism to allow the struts to extend outwardly and deploy the filter.

In still another configuration, the restraining member or mechanism includes a plurality of channels. These channels are formed on both first and second ends of the filter in an offset configuration. The securing member can pass through one or more of the channels formed in the first side and the second side to maintain the first side in cooperative engagement with the second side. In this manner, the restraining member or mechanism applies a restraining force to the one or more struts and prevents them from extending outwardly. Upon moving the securing member in a proximal direction, a distal end of the securing member is removed from within the channels formed in the first side and second side, thereby releasing the restraining force applied by the restraining member or mechanism against the one or more struts.

In still another configuration, the restraining member or mechanism has the form of a sleeve that is adapted with one or more hoops formed therein. The wire forms a channel by maintaining a first set of hoops and second set of hoops in engagement using a securing member. By removing the securing member from engaging within one or more of the hoops, the first side and second side of the restraining member or mechanism can disengage with one another and release the restraining force that was applied to the one or more struts. In this manner, the struts are able to deploy the filter.

In yet another configuration, the restraining member or mechanism is combined with the one or more struts of the filter device. In such a configuration, two or more of the struts include tubular members adapted to receive a securing member. As the struts are brought towards each other, the lumens of the tubular members become aligned so that the securing member can pass therethrough to prevent the struts from extending outwardly or otherwise maintain the struts together or in close proximity one to another.

In still another configuration, the restraining member or mechanism is combined with the filter of the filter device. In this configuration, the filter includes at least one flap that is adapted to extend through the gap disposed between two struts. The flap(s) can be wrapped around the struts and secured to prevent the struts from extending outwardly.

These and other objects and features of the present invention will become more fully apparent from the following description and appended claims, or may be learned by the practice of the invention as set forth hereinafter.

BRIEF DESCRIPTION OF THE DRAWINGS

To further clarify the above and other advantages and features of the present invention, a more particular description of the invention will be rendered by reference to specific embodiments thereof which are illustrated in the appended drawings. It is appreciated that these drawings depict only typical embodiments of the invention and are therefore not to be considered limiting of its scope. The invention will be described and explained with additional specificity and detail through the use of the accompanying drawings in which:

FIG. 1 illustrates an exemplary filter device according to one embodiment of the present invention.

FIG. 2 illustrates an exploded perspective view of an exemplary tip of the filter device of FIG. 1.

FIG. 3 illustrates a cross-sectional side view of the exemplary tip of the filter device of FIG. 2.

FIGS. 4A-4I illustrates various cross-sectional side views of different exemplary configurations or embodiments of the tip of the filter device of FIG. 2.

FIG. 5 illustrates a cross-sectional side view of the tip of the filter device of FIG. 2 with exemplary actuating member and filter assembly in a closed position.

FIG. 6a illustrates a cross-sectional side view of the tip of the filter device of FIG. 2 with exemplary actuating member and filter assembly in an actuated position.

FIG. 6b illustrates one or more pores of the filter of the filter device of the present invention.

FIG. 7 illustrates a cross-sectional side view of the tip of the filter device of FIG. 2 with exemplary actuating member and filter assembly in an actuated position and a portion of the filter filled with material.

FIG. 8 illustrates a cross-sectional side view of the tip of the filter device of FIG. 2 with exemplary actuating member and filter assembly in a retracted position.

FIG. 9 illustrates a cross-sectional side view of an exemplary actuating assembly of the filter device of FIG. 2.

FIG. 10 illustrates a perspective view of one exemplary capture catheter adapted for use with the filter device of the present invention.

FIG. 11 illustrates a cross-sectional side view of the actuating member and filter assembly in a retracted position with the capture catheter in position surrounding the filter of the filter device of FIG. 2.

FIG. 12 illustrates a flow diagram of an exemplary method for using the filter device of FIG. 2.

FIG. 13 illustrates a portion of the vasculature of an individual within which the filter device of FIG. 2 can be inserted.

FIG. 14 illustrates a lesion formed in the interior carotid artery of the individual of FIG. 13.

FIG. 15 illustrates one embodiment of the filter device of FIG. 2 deployed in the interior carotid artery distal of the lesion of FIG. 14.

FIG. 16 illustrates one embodiment of the filter device of FIG. 2 deployed in the interior carotid artery distal of the lesion of FIG. 14 and a pre-dilation balloon.

FIG. 17 illustrates one embodiment of the filter device of FIG. 2 deployed in the interior carotid artery distal of the lesion of FIG. 14 and a stent located about the lesion.

FIG. 18 illustrates a partial cross-sectional side view of another embodiment of the filter device of the present invention.

FIG. 19 illustrates a cross-sectional side view of another exemplary actuating assembly of the filter device according to the present invention.

FIG. 20 illustrates a partial cross-sectional view of yet another embodiment of the filter device of the present invention.

FIG. 21 illustrates a side view of a tip of the filter device of FIG. 20.

FIG. 22 illustrates a side view of the embodiment of FIG. 20 with the filter deployed.

FIG. 23 illustrates a side view of yet another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention.

FIG. 24 illustrates a side view of the embodiment of FIG. 23 with the filter deployed.

FIG. 25 illustrates a cross-sectional side view of another exemplary actuating assembly of the filter device according to the present invention.

FIG. 26 illustrates a perspective view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention.

FIG. 27 illustrates a perspective view of the restraining member of FIG. 26 before becoming coupled to the filter device according to another aspect of the present invention.

FIG. 28 illustrates a perspective view of the restraining member of FIG. 26 before becoming coupled to the filter device according to another aspect of the present invention.

FIG. 29 illustrates a perspective view of another restraining member of the filter device according to another aspect of the present invention.

FIG. 30 illustrates a perspective view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention.

FIG. 31 illustrates a perspective view of the restraining member of FIG. 30 before becoming coupled to the filter device according to another aspect of the present invention.

FIG. 32 illustrates a side view of the restraining member of FIG. 30 before becoming coupled to the filter device according to another aspect of the present invention.

FIG. 33 illustrates a side view of the restraining member FIG. 30 part way through restraining the filter device according to another aspect of the present invention.

FIG. 34 illustrates a side view of the restraining member FIG. 30 as it restrains the filter device according to another aspect of the present invention.

FIG. 35 illustrates a perspective view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention.

FIG. 36 illustrates a perspective view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention.

FIG. 37 illustrates a side view of the restraining member of FIG. 36 before becoming coupled to the filter device according to another aspect of the present invention.

FIG. 38 illustrates a side view of the restraining member of FIG. 36 before becoming coupled to the filter device according to another aspect of the present invention.

FIG. 39 illustrates perspective view of the restraining member FIG. 36 as it restrains the filter device according to another aspect of the present invention.

FIG. 40 illustrates a perspective side view of another embodiment of a filter device with a restraining member coupled to the filter device according to another aspect of the present invention.

FIG. 41 illustrates a perspective side view of the restraining member FIG. 40 as it restrains the filter device according to another aspect of the present invention.

FIG. 42 illustrates a side view of another embodiment of a filter device according to another aspect of the present invention.

FIG. 43 illustrates a side view of yet another embodiment of a filter device according to another aspect of the present invention.

FIG. 44 illustrates a perspective view of another embodiment of a capture catheter used with the filter device of the present invention.

FIG. 45 illustrates a perspective view of yet another embodiment of a capture catheter used with the filter device of the present invention.

FIG. 46 illustrates a perspective view of still another embodiment of a capture catheter used with the filter device of the present invention.

FIG. 47 illustrates a side view of the capture catheter of FIG. 46 as it begins to capture the filter device of the present invention.

FIG. 48 illustrates a side view of the capture catheter of FIG. 46 as it captures the filter device of the present invention.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

The present invention generally relates to percutaneous filter devices, systems, and methods of using the same. Embodiments of the present invention can be utilized in association with devices, systems, and methods for inserting a filter device, such as but not limited to a vascular filter device, within any blood vessel of a patient.

One or more of the embodiments of the filter devices of the present invention meet criteria for both guidewires and filter devices. For instance, it is preferable that a guidewire is steerable. Consequently, embodiments of the filter device of the present invention can be insertable within any blood vessel of a patient, such as but not limited to, coronary artery, carotid arteries, renal arteries, bypass grafts, superficial femoral artery, the arteries of the upper and lower extremities, or cerebral vasculature, and manipulated and steered by a physician to traverse the tortuous anatomy of the patient to a lesion or occlusion.

To assist the physician with the above-recited endeavor, one or more embodiments of the filter device include a shapeable, soft, distal tip. In addition, the filter device is capable of translating rotational movement or force applied to the proximal end thereof substantially equally to the distal end. In other words, with the filter device positioned within a vessel of the patient, as a physician rotates the proximal end of the filter device, the distal end of the filter device rotates substantially simultaneously with the movement of the proximal end. This is typically defined as having a one-to-one torqueability.

Further, the filter device of the present invention is kink resistant and is capable of receiving a variety of different coatings to improve lubricity, have anti-thrombogenic properties, and/or reduce platelet aggregation. These coatings can include, but are not limited to, a hydrophilic coating, a heparinized coating, Teflon, silicone, or other coating known to those skilled in the art in light of the teaching contained herein.

With respect to the filter of the filter device of the present invention, in one embodiment, the filter is configured to capture material of a variety of sizes and enable removal of the captured material. Therefore, filter pore sizes and shapes can be selected based upon the size of material to be captured. The material can include but is not limited to, particulates, thrombi, any atherosclerosis or plaque material dislodged during a procedure, or other foreign material that may be introduced in to the vasculature of the patient.

Referring now to FIG. 1, depicted is one embodiment of a vascular filter device, designated by reference number 10, of the present invention. As illustrated, filter device 10 includes a guide member 12 having a distal end 14 and a proximal end 16. Extending between distal end 14 and proximal end 16 of guide member 12 is a lumen 18 within which is disposed an actuating member 40 and a filter assembly 42. Distal end 14 of guide member 12 includes a tip 15 that is configured for percutaneous insertion into a blood vessel of a patient, while proximal end 16 is configured with or couples to an actuating assembly 20.

In this configuration, filter device 10 is capable of being insertable into any blood vessel of a patient or body and function as a guidewire or exchange wire for other medical components or devices, such as but not limited to catheters, stents, balloons, atherectomy devices, or other components or devices that can be exchanged using a guidewire. Further, filter device 10 can be used to filter particulates, as will be described in more detail hereinafter, thereby acting or providing embolic protection during a procedure.

Illustratively, the term "guide member" can refer to a member that is completely solid, such as a guidewire, a member that partially includes a lumen therein, or a member that includes a lumen extending from a proximal end to a distal end thereof, such as a hypo-tube. Consequently, the term "guide member" can include or encompass a guidewire or a hypo-tube that is configured to perform the functions described herein.

Guide member 12 can be fabricated from a variety of materials. For example, guide member 12 can be fabricated from Nitinol, steel, metals, metal alloys, composites, plastic, polymer, synthetic materials, or combinations thereof. Further, guide member 12 can be covered with a variety of different coatings, such as but not limited to, coatings to improve lubricity or having anti-thrombogenic properties, reduce platelet aggregation, hydrophilic coatings, a heparinized coating, Teflon, silicone, or combinations thereof.

Illustratively, guide member 12 can have an outside diameter of between about 0.010 inches to about 0.035 inches, between about 0.014 inches to about 0.018 inches, or between about 0.010 inches to about 0.018 inches. In one configuration, the outside diameter of guide member 12 is about 0.014 inches. Similarly, the diameter of lumen 18 can range from about 0.004 inches to about 0.029 inches or between about 0.008 inches to about 0.014 inches. In one configuration, the diameter of lumen 18 is about 0.008 inches.

As illustrated in FIGS. 2 and 3, the exemplary distal end 14 of guide member 12 has a step configuration, with a step portion 22 of guide member 12 having a smaller diameter than other portions of guide member 12. For ease of explanation, actuating member 40 and filter assembly 42 have been excluded from FIGS. 2 and 3.

The step portion 22 can have a variety of different configurations so long as it is adapted to couple with other portions of filter device 10. For instance, step portion 22 can include multiple steps instead of a single step as illustrated in FIG. 2. Consequently, distal end 14 of guide member 12 could include a first step portion having a first outer diameter smaller than the outer diameter of the remaining portion of guide member 12 toward proximal end 16 thereof. Further, distal end 14 of guide member 12 could include a second step portion having a smaller outer diameter than the first outer diameter of the first portion.

Attached to step portion 22 of guide member 12 is a sheath 24. Sheath 24 has a lumen 30 that extends between a distal end 26 and a proximal end 28 thereof. A portion of distal end 26 is substantially co-planar with distal end 14 of guide member 12 when sheath 24 is connected to guide member 12. Stated another way, a portion of distal end 14 of guide member 12 and distal end 26 of sheath 24 are contained within a plane that is substantially perpendicular to the longitudinal axis of lumen 18 of guide member 12 when sheath 24 is coupled, connected, or attached to guide member 12. Although this is the case in one embodiment of the present invention, one skilled in the art can identify various other configurations where this need not be the case. For instance, in an alternate configuration, distal ends 14 and 26 are not co-planar. In another configuration, portions of distal ends 14 and 26 are co-planar. In still another configuration, at least one of distal ends 14 and 26 is angularly orientated relative to the longitudinal axis of lumen 18 or lumen 30.

As illustrated in FIG. 3, distal end 26 of sheath 24, either alone or in combination with distal end 14 of guide member 12 is atraumatic. In this manner, as filter device 10 is inserted within a blood vessel filter device 10 is able to slide along the interior surface of the blood vessel and is prevented from catching upon protrusions, i.e., lesions, occlusions, stenosis, or the like, during a procedure. One skilled in the art can identify a variety of different configurations of distal ends 14 and/or 26 to perform such a desired function. For instance, the curvature of distal end 14 of guide member 12 can be varied as long as the curvature allows filter device 10 to slide along the interior surface of the blood vessel without catching upon protrusions; the curvature can be based upon distal end 14 of guide member 12 and/or the distal end of sheath 24.

Proximal end 28 of sheath 24 is configured to cooperate with a proximal end of step portion 22. Proximal end 28 of sheath 24 and the proximal end of step portion 22 are substantially parallel one to another upon coupling, connecting, or attaching sheath 24 to step portion 22. In another configuration, the proximal end of step portion 22 can include one or more raised portions within which one or more complementary recesses formed in proximal end 28 mate, or vice versa. In still another configuration, sheath 24 has a stepped configuration that allows matting with a complementary configured stepped proximal end of step portion 22, such as when step portion includes multiple steps. Various other configurations are applicable to allow sheath 24 and the remainder of guide member 12 to couple, connect, or be attached one to another.

According to another aspect of one embodiment of the present invention, sheath 24 has an outside diameter substantially the same as the outer diameter of guide member 12, while the diameter of lumen 30 is substantially the same as the outer diameter of step portion 22. Conseq