Electrostatic Vascular Filters
An intravascular filter is constructed to electrostatically capture and retain particles of a targeted type (for example fat or methacrylate emboli), even if those particles are physically small enough to slip through the filter in the absence of electrostatic attraction. Specific types of targeted particles are thereby captured and retained with improved efficiency, while permitting free flow of non-targeted particles. This improvement permits intravascular filters to be constructed with low-resistance, widely spaced filter elements. Accordingly, more targeted particles are captured, less thrombosis occurs, less pressure drop occurs across the filter, and perfusion or blood collection in downstream areas is maintained.
The present application is a Divisional of U.S. Pat. No. 12/383,094 filed Mar. 18, 2009 (Allowed), which application claims the benefit of priority of U.S. Provisional Appln. No. 61/037,983 filed Mar. 19, 2008. The full disclosures, each of which are incorporated herein by reference in their entirety for all purposes.
FIELD OF THE INVENTIONThe invention described herein relates to medical devices and methods of use thereof. More particularly, the invention relates to a retrievable intravascular filter and methods for filtering embolic material within a vessel of a subject.
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BACKGROUND OF THE INVENTION Fat and Fat EmbolismLipids may be classified as either “anionic” (e.g. most phospholipids), “cationic” (e.g. milk fat globules (Kiely and Olson 2003)), or “neutral”. Human fat tissue is an example of a lipid which in its living, unperturbed form, is electrically neutral. But once it is surgically or metabolically disrupted, human fat begins a breakdown into several lipid fractions, some positive, some negative, and some neutral. For example, free fatty acids (FFAs) are highly polarized molecules (de Vries et al 2004). The trans form free fatty acids (FFAs) carry a negative charge (Steinbeck et al 1991). FFAs are particularly harmful in the circulation. FFAs cause vasoconstriction and granulocytes activation through surface expression and activity of CD11b (Mastraneglo et al 1998). FFAs have been implicated in b-cell damage in the pancreas (Cnop et al 2002), tubulointerstitial damage in the kidney (Kamijo et al 2002), and acute respiratory distress syndrome in the lungs (Grotjohan et al .1996). Fortunately, because a FFA molecule is a highly polarized structure, filtration as a means to remove FFAs from the blood stream holds some promise. In fact, extracorporeal, (i.e., outside the human body) mechanical blood filtration targeting fat has been demonstrated in blood from orthopedic patients (Ramirez et al 2002). Similar extracorporeal mechanical filtration during cardiac surgery has shown that FFAs are retained by the filter particularly well, a phenomenon that is thought likely to be related to the polarity of the FFA molecule (de Vries et al 2004).
The embolization of fat particles into organs including the lung and brain is an important cause of medical morbidity, particularly following orthopedic trauma. When a bone is fractured, there is usually some fat released into the venous circulation. These particles are distributed downstream, particularly into the lung, but in most cases do not cause an obvious medical syndrome. Following orthopedic surgical procedures, however, the escaped fat particle load becomes very large, and a fat embolism syndrome may occur in a third of patients undergoing these procedures. Symptoms may range from mild respiratory distress with skin and eye symptoms, to severe pulmonary edema and death (Taviloglu et. al. 2007).
Methacrylate and Methacrylate EmbolismMethacrylate is frequently used in orthopedic surgery to affix implants and to remodel lost bone. Methyl methacrylate (MMA) polymerizes and thereby hardens into polymethyl methacrylate (PMMA). The polymer PMMA is a lipophilic molecule of varying chain length, with the molecular formula (C5O2H8)n. It is Sold under a variety of medical and non-medical trade-names including the familiar “Plexiglas”. The two hydroxyl groups carry a negative electrostatic propensity, while the hydrogens impart positive charges. Consequently, the molecule has intrinsic electrostatic properties which become manifest under various polymerization and ambient pH conditions. Additionally, methacrylate molecules may be purposefully made to bear either a positive or a negative charge by means known in the art. For example, Peng et al. describe “a facile and organic-solvent-free method” involving the production of positively charged PMMA by emulsion polymerization, in which a cationic element such as the monomer methacryloyloxyethyltrimethylammonium chloride (METAC) is copolymerized with methacrylate. Likewise, negatively charged PMMA is produced using anionic comonomer sodium 2-acrylamido-2-methylpropanesulphonate (NaAMPS) (Peng. et al. 2006). Particles of these materials, however, are frequently taken away from the operative site by nearby veins. When the particles are brought into the fine capillaries of the lung or other regions of the body, circulatory blockages and tissue damage may result.
Intravascular Filter Usage and Design ConsiderationsThe engineering of vascular filters is complicated by the need to make the particle-capturing mesh tight enough to capture the targeted particles, but not so tight so as to impede circulation, or otherwise cause thrombus formation on the mesh. An excessively loose mesh (in which the spaces between the filter elements are too distant) results in failure to capture smaller emboli. Conversely, a mesh that is too tight (in which filter elements are too close to one another) increases the resistance to blood flow, and may trap particles indiscriminately, leading to early thrombosis and occlusion of paths through the filter.
Electrostatic FiltersElectrostatic filters are known principally for use in water filtration, cleaning of fabric, air/allergen filtration, and in food processing, but have not been adapted to the unique environment and demands of intravascular use.
It would be desirable to have a venous filter capable of capturing small embolic particles, including the most dangerous fatty acids, without attracting platelets and promoting thrombosis. It would also be desirable to deploy such a filter via a catheter prior to a high-embolic-risk procedure; and to be able to retrieve it at the conclusion of that procedure.
The invention set forth herein relates to a retrievable protective mesh which is inserted into a blood vessel which is deemed at risk for delivering potentially harmful embolic particles to distal organs. This mesh is deployed via catheter, or by direct cut-down into the vein, and is of sufficient patency to allow normal blood cells and small clumps of cellular material through. In particular, this intravascular filter is constructed to employ electrostatic forces in a manner that permits adhesive forces to capture particles of the targeted type (for example fat or methacrylate emboli), and to retain these particles, even those which might otherwise be physically small enough to slip through the filter. Specific types of targeted particles are thereby captured and retained with improved efficiency, permitting filter elements to be more widely spaced than would otherwise be necessary, thereby decreasing both resistance and the propensity for thrombosis. The device is designed to be retrieved post-op, and the accumulated debris on the mesh analyzed in the laboratory. The device provides protection from embolism and stroke resulting from debris released by sites of tissue trauma. The device provides protection from embolism and stroke resulting from debris released by sites of tissue trauma.
BRIEF SUMMARY OF THE INVENTIONA filter system for removal of embolic particles from a blood vessel of a subject is disclosed, where the system has a filtration element deployable within a blood vessel of the subject. At least a portion of the filtration element is electrically conductive, and either an anode or a cathode is in electrical communication with the filtration element. Embolic particles carrying an electrostatic charge opposite that of said anode or said cathode are attracted to the filtration element. The embolic particles may be lipids or methacrylate. The filtration element may further comprise a mesh, one or more struts, and/or one or more purse strings. The system may be constructed to entrap emboli and/or embolic material, some of which may comprise a diameter of 10 microns.
The filter system may further comprise a delivery configuration and a deployed configuration whereby said system may be delivered and deployed in a minimally invasive percutaneous manner. The system may also be retrieved from the vessel of a subject in a minimally invasive percutaneous manner.
As shown in
In
Alternatively, if the mesh 466, ring 465 and struts 460 are too large; or too full of filtered debris 457, they may be retracted through the incision following the removal of guide catheter 476.
The various embodiments described above are provided by way of illustration only and should not be construed to limit the invention. Based on the above discussion and illustrations, those skilled in the art will readily recognize that various modifications and changes may be made to the present invention without strictly following the exemplary embodiments and applications illustrated and described herein. Such modifications and changes do not depart from the true spirit and scope of the present invention; which is set forth in the following claims.
Claims
1. A method for filtering embolic material with an electrostatic charge from a vessel of a subject, the method comprising the steps of:
- providing a filter system comprising a first filtration element configured to carry a stable electrostatic charge;
- delivering said filter system to a treatment site within a vessel of a subject;
- deploying said filter system by expanding the filter system from a low-profile insertion configuration to an expanded-profile filter configuration within the vessel;
- electrostatically trapping oppositely charged electrostatic particles in the vessel to the first filtration element with the electrostatic charge.
2. (canceled)
3. The method according to claim 1 wherein said first filtration element is delivered to the vessel in a lumen of an elongate catheter in the low-profile configuration.
4. (canceled)
5. The method of claim 1, wherein the first filtration element comprises a filtration mesh configured to collapse to prevent the escape of electrostatically trapped particles during removal of said filter system from the vessel.
6. The method of claim 5 further comprising, removing the filter system from the vessel by withdrawing the filter system into a lumen of an elongate catheter and wherein a purse string is configured to collapse the first filtration element to a delivery configuration so as to facilitate the withdrawing of the filter system into the lumen.
7. The method of claim 1 wherein the first filtration element is configured to carry a negative electrostatic charge such that positive charged electrostatic particles may be electrostatically trapped and removed from the vessel and negative charged electrostatic particles may be repelled from the first filtration element to remain in the vessel.
8. The method of claim 1 wherein the first filtration element is configured to carry a positive electrostatic charge such that negative charged electrostatic particles may be electrostatically trapped and removed from the vessel.
9. The method of claim 1 wherein the first filtration element comprises a filtration mesh having perforations and wherein a portion of the electrostatically trapped particles are smaller than the perforations of the filtration mesh.
10. The method of claim 1 wherein the first filtration element is elongate and configured such that the blood flows parallel to the filtration element with low resistance when the filter system is deployed.
11. The method of claim 1, wherein the filter system further comprises a second filtration element adjacent to the first filtration element, the second filtration element configured to carry a stable electrostatic charge opposite the electrostatic charge of the first filtration element; and
- the method further comprising electrostatically trapping oppositely charged electrostatic particles in the vessel to the second filtration element with the electrostatic charge.
12. The method of claim 1 further comprising imparting an electrostatic charge on the first filtration element with a direct current.
13. The method of claim 12 wherein the direct current is supplied by a battery.
14. The method of claim 12 wherein the electrostatic charge is imparted on the first filtration element by coupling an anode or cathode to the first filtration element.
15. The method of claim 12 wherein the electrostatic charge is imparted on the first filtration element by coupling a anode or cathode to the first filtration element and an oppositely corresponding anode or cathode is coupled to an intravascular location.
16. A method for filtering electrostatically charged particles from blood flow in a blood vessel, the method comprising:
- delivering an intravascular filter comprising one or more filtration elements to a treatment site in the blood vessel;
- deploying the intravascular filter by expanding the filter from a low-profile insertion configuration to an expanded-profile filter configuration within the blood vessel;
- imparting a stable electrostatic charge on the one or more filtration elements;
- maintaining the stable electrostatic charge on the one or more filtration elements while the one or more filtration elements are in the blood vessel; and
- electrostatically trapping particles in the blood vessel which have an opposite electrostatic charge to the one or more filtration elements using the imparted electrostatic charge.
17. The method of claim 16, wherein the one or more filtration elements comprise elongate filtration elements and wherein the blood flows parallel to the one or more filtration elements with low resistance.
18. The method of claim 17, wherein the intravascular filter comprises at least two elongate filtration elements adjacent to one another.
19. The method of claim 16, wherein the filtration element comprises a filtration mesh with pore sizes larger than a targeted electrostatic particle size.
20. A method for removing positive charged particles from blood flow in a blood vessel, the method comprising:
- delivering an intravascular filter comprising a filtration element to a treatment site in the blood vessel;
- imparting a stable negative electrostatic charge on the filtration element;
- maintaining the stable negative electrostatic charge on the filtration element while the filtration element is in the blood vessel;
- electrostatically trapping particles in blood flowing in the blood vessel which have a positive electrostatic charge to the filtration element using the imparted negative electrostatic charge; and
- withdrawing the intravascular filter from the treatment site so as to remove the electrostatically trapped particles.
Type: Application
Filed: Aug 8, 2012
Publication Date: Mar 21, 2013
Inventors: M. Bret Schneider (Portola Valley, CA), Rogelio Moncada (New Orleans, LA)
Application Number: 13/569,405
International Classification: A61F 2/01 (20060101);