Endovascular filter and method for use thereof

• US 5,160,342 A
• Filed: 12/30/1991
• Issued: 11/03/1992
• Est. Priority Date: 08/16/1990
• Status: Expired due to Fees

• Current Assignee: Synectic Ventures III LLC (Synectic Asset Management, Inc.), Synectic Ventures II LLC (Synectic Asset Management, Inc.), Synectic Ventures I LLC (Synectic Asset Management, Inc.)
• Original Assignee: Evi Corp.
• Inventors: Kelly, Thomas L., Reger, Vincent A., Groshong, LeRoy E.
• Primary Examiner(s): Thaler, Michael H.
• Application Number:
  US07/814,141
• Time in Patent Office: 309 Days
• Field of Search: 606/200, 606/159, 606/198, 604/22, 128/899
• US Class Current: 606/200
• CPC Class Codes: A61B 17/320725 with radially expandable cutting or abrading elements A61B17/32075 takes precedence
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped

Abstract

A filter useful in tubular organs of the human body, intended primarily for endovascular use during surgical procedures for removal of plaque and other treatment of stenoses in arteries, in order to entrap particles of plaque or other materials freed from the interior wall of an artery while permitting continued flow of blood through the artery during the procedure of treating the stenosis. Several filter elements are fastened in apart-spaced relationship with one another along a flexible elongate member and are large enough to require the entire flow of blood through the artery to pass through the filter elements. An open-mouthed tubular stocking of porous filter material encloses the filter elements and supports the periphery of each filter element. Successive filter elements, progressing in the direction of blood flow, pass only progressively smaller particles. In a preferred embodiment, the mouth of the stocking can be closed to retain particles of material within the filter as it is withdrawn from the artery after repair of a stenosis.

Claims

1. An endovascular filter device, comprising:

(a) a slender flexible elongate support member disposed at the longitudinal axis of the filter device over the entire length of the filter device in all operational states having a proximal end and a distal end adapted for insertion into and along the interior of a blood vessel; and

(b) a filter assembly, including

(i) a flexible tubular porous stocking surrounding a portion of said elongate support member proximate said distal end and having a closed end non-rotationally attached to said elongate support member and a mouth directed generally toward said proximal end of said elongate support member;

(ii) means for supporting said tubular porous stocking with said mouth open to receive a flow of blood in a flow-receiving and filtering position within said blood vessel; and

(iii) means for spirally rotating said tubular porous stocking at said mouth whereby said mouth is closed about said elongate support member and said stocking is positively constrained from being unfurled when twisted about said elongate support member to capture and retain materials filtered from said flow of blood within said stocking.

2. The filter device of claim 1 wherein said elongate support member is a two-stage guide wire including a tubular outer member defining a lumen and an inner core member disposed within said lumen, said closed end being attached to said core member and said mouth being interconnected with said outer member.

3. The device of claim 2, including detent means for retaining said inner core wire in a desired location with respect to said outer member.

4. A method of relieving a stenosis in a blood vessel, comprising:

(a) providing an endovascular filter device including a tubular stocking of a flexible filter medium attached to and surrounding a portion of an elongate flexible guide wire disposed at the longitudinal axis of the filter device over the entire length of the filter device in all operational states with a distal end of said tubular stocking being effectively closed and attached to said guide wire and with a mouth of said stocking also being closed when said tubular stocking is furled about the surrounded portion of the elongate guide wire;

(b) forming an opening in a blood vessel in a location proximal of a stenotic portion thereof and inserting said guide wire into said blood vessel through said opening, with said tubular stocking in a furled configuration;

(c) extending said filter device into said blood vessel until said stocking has passed through and a predetermined distance beyond a stenotic portion of said blood vessel;

(d) thereafter unfurling said stocking so as to deploy said stocking across the interior of said blood vessel and opening the mouth of said stocking thereby;

(e) thereafter enlarging the lumen of said blood vessel by freeing pieces of material from the stenotic portion of the blood vessel; and

(f) entrapping within said stocking said pieces of material thus freed from said stenotic portion;

(g) capturing the entrapped pieces for retrieval from said blood vessel by spirally rotating and thereby closing said mouth and twisting said tubular stocking about the entrapped pieces.

5. A method of relieving a stenosis in a blood vessel, comprising:

(a) providing an endovascular filter device, including a slender flexible elongate support member disposed at the longitudinal axis of the filter device over the entire length of the filter device in all operational states and having a proximal end and a distal end adapted for insertion into and along the interior of a blood vessel and a flexible tubular porous stocking surrounding a portion of said elongate support member, the stocking having a mouth directed generally toward said distal end of said elongate member, as well as a closed end surrounding said elongate member and located more proximally along said elongate member than the location of said mouth, and means for supporting said tubular stocking coaptively against the inner surface of said blood vessel with said mouth open to receive a flow of blood;

(b) forming an opening in a blood vessel in a location downstream of a stenotic portion thereof by reference to the normal flow of blood, and inserting said flexible elongate support member into said blood vessel through said opening, with said stocking in a furled configuration;

(c) extending said filter device into said blood vessel until said stocking has approached to within a predetermined distance from said stenotic portion on a downstream side of said stenotic portion of said blood vessel;

(d) thereafter unfurling said stocking so as to deploy said stocking within said blood vessel with said mouth of said stocking substantially in intimate contact with the interior of said blood vessel;

(e) thereafter enlarging the lumen of said blood vessel by freeing pieces of material from said stenotic portion thereof; and

(f) entrapping within said stocking said pieces of material thus freed from said stenotic portion;

(g) capturing the entrapped pieces of material for retrieval from the blood vessel by spirally rotating said mouth about said elongate member and thereby enclosingly twisting said stocking about the entrapped pieces.

6. The method of claim 5, including the further step of withdrawing said filter device from said blood vessel with said material retained within said stocking.

7. The method of claim 5 including drawing the mouth of said stocking tightly closed as a part of said step capturing the entrapped pieces.

8. A method of increasing the size of a lumen of a blood vessel at a stenotic site, comprising the steps of:

(a) interjecting an endovascular filter device comprising a slender elongate support member and means for filtering blood borne particulates, attached and furled about the distal end of said support member, into the blood vessel until the particulate filtering means are disposed a predetermined distance downstream of the site;

(b) manually moving drawstring means in a first direction to unfurl and thereby deploy said particulate filtering means within said blood vessel such that exterior portions of said particulate filtering means coapt with the interior of said blood vessel and a mouth of the particulate filtering means is opened to receive particulates excised from the site;

(c) interposing a means of excising occluding matter within said blood vessel and guiding said occluding matter excising means toward said site along said elongate support member;

(d) using the occluding matter excising means, excising occluding matter from the site to enlarge the lumen;

(e) manually moving said drawstring means in a second direction to spirally rotate and thereby close the mouth and to twist the filter means about excised particulates to assuredly and constrainably entrap the particulates freed from said stenotic site.

9. The method according to claim 8 wherein the using step further comprises removing the occluding matter excising means and reinserting said occluding matter excising means one or more times.

10. The method according to claim 8 comprising separately withdrawing the occluding matter excising means from the site and from the blood vessel at the end of the excising procedure.

11. A method of increasing the size of a lumen of a blood vessel at a stenotic site, comprising the steps of:

(a) interjecting an endovascular filter device comprising a slender elongate support member disposed at the longitudinal axis of the filter device over the entire length of the filter device in all operational states and means for filtering blood borne particulates, attached and furled about the distal end of said support member, into the blood vessel until the particulate filtering means are disposed a predetermined distance downstream of the site;

(b) unfurling and thereby deploying said particulate filtering means within said blood vessel such that exterior portions of said particulate filtering means coapt with the interior of said blood vessel and a mouth of the particulate filtering means is open to receive particulates excised from the site;

(c) interposing a means of excising occluding matter within said blood vessel and guiding said occluding matter excising means toward said site along said elongate support member;

(d) using the occluding matter excising means, excising occluding matter from the site to enlarge the lumen;

(e) entrapping within said particulate filtering means excised particulates freed from said stenotic site; and

(f) capturing the entrapped particulates for fully contained removal from said blood vessel by twisting said particulate filtering means about the elongate support member to furl the particulate filtering means and thereby securely enshroud the particulates for safe transport out of said blood vessel.

12. The method according to claim 11 wherein the capturing step comprises capture by spirally rotating the mouth of said particulate filtering means about said elongate member to thereby twist said stocking about the entrapped pieces.

13. The method according to claim 11 comprising the further step of withdrawing the endovascular filtering device following withdrawal of the occluding matter excising means.

14. The method according to claim 11 comprising the further step of withdrawing the endovascular filtering device from the blood vessel at essentially the same time the occluding matter excising means are withdrawn from the blood vessel.

15. A method of increasing the size of a lumen of a blood vessel at a stenotic site, comprising the steps of:

(a) interjecting an endovascular filter device comprising a slender elongate support member disposed at the longitudinal axis of the filter device over the entire length of the filter device in all operational states and means for filtering blood borne particulates, tightly and constrainably furled and twisted about said elongate support member and rigidly attached to the distal end of said elongate support member at the distal end of the filter means, into the blood vessel until the particulate filtering means are disposed a predetermined distance downstream of the site;

(b) unfurling and untwisting and thereby deploying said particulate filtering means within said blood vessel such that exterior portions of said particulate filtering means coapt with the interior of said blood vessel and a mouth of the particulate filtering means is open to receive particulates excised from the site;

(c) interposing a means of excising occluding matter within said blood vessel and guiding said occluding matter excising means toward said site along said elongate support member;

(d) using the occluding matter excising means, excising occluding matter from the site to enlarge the lumen; and

(e) entrapping within said particulate filtering means excised particulates freed from said stenotic site and thereby trapping particulates of at least one larger size at at least one upstream filtering means and trapping particulates of at least one smaller size at at least one downstream filtering means.

16. An expandable and collapsible filter assembly in combination with an elongate support member of a catheter for use in a blood vessel of a patient, said combination comprising:

an elongate support member disposed at the longitudinal axis of the filter assembly over the entire length of the filter assembly in all operational states;

at least one filter element comprising means for attaching said at least one filter element to said elongate support member at a first filter assembly end and means extending from said attaching means for supporting a flexible tubular porous stocking which forms an exterior surrounding wall of said filter assembly, said supporting means comprising radially outwardly extending ribs of sufficient flexibility to permit the stocking to be twisted and furled and a mouth of the stocking to be spirally closed thereby and which provide support for at least one transversely disposed filter;

the tubular porous stocking attached and circumferentially supported on the first filter assembly end to form the mouth for influent flow and to therefrom coapt with the surrounding blood vessel to a site where the stocking is closed by rigid, non-rotational attachment to the elongate support member on a second filter assembly end to form a filtering means for filtering effluent flow from said filter assembly.

17. The expandable and collapsible filter assembly according to claim 16 further comprising means for assuredly and constrainably furling said tubular porous stocking in association with the spiral rotation of said mouth to capture particulates entrapped in said filter assembly for retrieval thereof from the blood vessel.

18. The expandable and collapsible filter assembly according to claim 16 further comprising means for disposing said first filter assembly end distally relative to an insertion site of said catheter.

19. The expandable and collapsible filter assembly according to claim 16 wherein said at least one filter element is at least two filter elements.

20. The expanded and collapsible filter assembly according to claim 16 wherein the filtering means comprise a smaller filter pore size than each transversely disposed filter of the at least one filter element.

21. The expandable and collapsible filter assembly according to claim 16 further comprising means for integrally rotating and twisting said flexible tubular porous stocking to collapse the filter assembly about entrapped particulates thereby securely capturing said particulates for retrieval as the filter assembly is retrieved from a blood vessel.

22. The expandable and collapsible filter assembly according to claim 21 wherein said rotating and twisting means comprise means for expanding said filter assembly from a furled state to an unfurled state.