Endovascular filter

• US 20070203520A1
• Filed: 01/16/2007
• Published: 08/30/2007
• Est. Priority Date: 06/07/1995
• Status: Abandoned Application

• Current Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated), William Cook Europe ApS (Cook Group Incorporated)
• Original Assignee: Cook Incorporated (Cook Group Incorporated), MED Institute, Inc. (Cook Group Incorporated), William Cook Europe ApS (Cook Group Incorporated)
• Inventors: Molgaard-Nielsen, Arne, Osborne, Thomas, Griffin, Dennis, Bates, Brian, Kozma, Thomas, Fearnot, Neal, Ragheb, Anthony, Voorhees, William, Leonard, Raymond
• Application Number:
  US11/654,278
• Publication Number:
  US 20070203520A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0086 Pyramidal, tetrahedral, or wedge-shaped
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

Endovascular filter (10) including a plurality of struts (14) with distal ends (18) adapted to anchor the filter to the vessel wall after deployment, such as by having barbs (20), the filter being adapted to be retrieved if desired. Strut distal ends (18) are coated with an antiproliferative agent (40) that inhibits the ingrowth of tissue around the filter, thereby permitting the filter to be retrieved and removed atraumatically after a prolonged period of time, thus extending the useful life of the retrievable filter. Optionally, the proximal end (22) of the filter may also be so coated, or the entire filter.

Claims

1. A collapsible vena cava filter for introduction into a blood vessel of a patient comprising:

an apical hub;

a plurality of struts secured to and diverging from said apical hub, each of said plurality of struts terminating in holding mechanisms that engage the walls of the blood vessel to secure the filter in a selected location therein;

a bioactive coating defining an exterior surface of said filter and configured to contact the walls of the blood vessel to prevent the growth of tissue that would interfere with removal of the filter; and

wherein said bioactive coating includes about 0.1 to 10.0 μ

g of bioactive material per 1.0 mm² of a coated surface area of the filter.

2. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 1 wherein the bioactive coating is paclitaxel.

3. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 1 wherein the bioactive coating is dexamethasone or related compounds.

4. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 1 wherein the exterior surface defined by the bioactive coating includes surfaces of the apical hub and struts that could engage the vessel wall.

5. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 1 wherein the exterior surface defined by the bioactive coating includes the entire exterior surface of the filter.

6. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 1 wherein an excipient may be associated with said bioactive coating.

7. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 4 wherein the bioactive coating is paclitaxel.

8. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 1 wherein the bioactive coating includes at least one of heparin, covalent heparin, or another thrombin inhibitor, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, or another antithrombogenic agent, or mixtures thereof;

urokinase, streptokinase, a tissue plasminogen activator, or another thrombolytic agent, or mixtures thereof;

a fibrinolytic agent;

a vasospasm inhibitor;

a calcium channel blocker, a nitrate, nitric oxide, a nitric oxide promoter or another vasodilator;

Hytrin®

or other antihypertensive agents;

an antimicrobial agent or antibiotic;

aspirin, ticlopidine, a glycoprotein IIb/IIIa inhibitor or another inhibitor of surface glycoprotein receptors, or another antiplatelet agent;

colchicine or another antimitotic, or another microtubule inhibitor, dimethyl sulfoxide (DMSO), a retinoid or another antisecretory agent;

cytochalasin or another actin inhibitor;

or a remodelling inhibitor;

deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention;

methotrexate or another antimetabolite or antiproliferative agent;

tamoxifen citrate, Taxol®

or the derivatives thereof, or other anti-cancer chemotherapeutic materials;

dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid or non-steroidal antiinflammatory agent;

cyclosporin or another immunosuppressive agent;

trapidal (a PDGF antagonist), angiopeptin (a growth hormone antagonist), angiogenin, a growth factor or an anti-growth factor antibody, or another growth factor antagonist;

dopamine, bromocriptine mesylate, pergolide mesylate or another dopamine agonist;

⁶⁰Co (5.3 year half life), ¹⁹²Ir (73.8 days), ³²P (14.3 days), ¹¹¹In (68 hours), ⁹⁰Y (64 hours), ^99mTc (6 hours) or another radiotherapeutic material;

iodine-containing compounds, barium-containing compounds, gold, tantalum, platinum, tungsten or another heavy metal functioning as a radiopaque agent;

a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component or another biologic agent;

captopril, enalapril or another angiotensin converting enzyme (ACE) inhibitor;

ascorbic acid, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-aminosteroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant;

a ¹⁴C—

, ³H—

, ¹³¹I—

, ³²P—

or ³⁶S-radiolabelled form or other radiolabelled form of any of the foregoing;

estrogen or another sex hormone;

AZT or other anti polymerases;

acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium, Norvir, Crixivan, or other antiviral agents;

5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123 or other photodynamic therapy agents;

an IgG2 Kappa antibody against Pseudomonas aeruginosa exotoxin A and reactive with A431 epidermoid carcinoma cells, monoclonal antibody against the noradrenergic enzyme dopamine beta-hydroxylase conjugated to saporin or other antibody targeted therapy agents;

gene therapy agents; and

enalapril and other prodrugs;

Proscar®

or other agents for treating benign prostatic hyperplasia (BHP) or a mixture of any of these; and

various forms of small intestine submucosa (SIS).

24. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 1 wherein said bioactive coating includes about 1.0 to 5.0 μ

g of bioactive material per 1.0 mm² of the coated surface area of the filter.

25. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 24 wherein said bioactive coating includes about 3.0 μ

g of bioactive material per 1.0 mm² of the coated surface area of the filter.

9. A collapsible vena cava filter for introduction into a blood vessel of a patient comprising:

an apical hub;

a plurality of struts secured to and diverging from said apical hub, each of said plurality of struts terminating in holding mechanisms that engage the walls of the blood vessel to secure the filter in a selected location therein;

a bioactive coating defining an exterior surface of said filter and configured to contact the walls of the blood vessel to prevent the growth of tissue that would interfere with removal of the filter; and

wherein said layer of bioactive coating contains about 100 μ

g to about 300 μ

g of drug per 0.001 inch of coating thickness.

10. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 9 wherein the bioactive coating is paclitaxel.

11. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 9 wherein the bioactive coating is dexamethasone or related compounds.

12. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 9 wherein the exterior surface defined by the bioactive coating includes surfaces of the apical hub and struts that could engage the vessel wall.

13. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 9 wherein the exterior surface defined by the bioactive coating includes the entire exterior surface area of the filter.

14. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 12 wherein the bioactive coating is paclitaxel.

15. A collapsible vena cava filter for introduction into a blood vessel of a patient as set forth in claim 9 wherein the bioactive coating includes at least one of heparin, covalent heparin, or another thrombin inhibitor, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, or another antithrombogenic agent, or mixtures thereof;

urokinase, streptokinase, a tissue plasminogen activator, or another thrombolytic agent, or mixtures thereof;

a fibrinolytic agent;

a vasospasm inhibitor;

a calcium channel blocker, a nitrate, nitric oxide, a nitric oxide promoter or another vasodilator;

Hytrin®

or other antihypertensive agents;

an antimicrobial agent or antibiotic;

aspirin, ticlopidine, a glycoprotein IIb/IIIa inhibitor or another inhibitor of surface glycoprotein receptors, or another antiplatelet agent;

colchicine or another antimitotic, or another microtubule inhibitor, dimethyl sulfoxide (DMSO), a retinoid or another antisecretory agent;

cytochalasin or another actin inhibitor;

or a remodelling inhibitor;

deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention;

methotrexate or another antimetabolite or antiproliferative agent;

tamoxifen citrate, Taxol®

or the derivatives thereof, or other anti-cancer chemotherapeutic materials;

dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid or non-steroidal antiinflammatory agent;

cyclosporin or another immunosuppressive agent;

trapidal (a PDGF antagonist), angiopeptin (a growth hormone antagonist), angiogenin, a growth factor or an anti-growth factor antibody, or another growth factor antagonist;

dopamine, bromocriptine mesylate, pergolide mesylate or another dopamine agonist;

⁶⁰Co (5.3 year half life), ¹⁹²Ir (73.8 days), ³²P (14.3 days), ¹¹¹In (68 hours), ⁹⁰Y (64 hours), ^99mTc (6 hours) or another radiotherapeutic material;

iodine-containing compounds, barium-containing compounds, gold, tantalum, platinum, tungsten or another heavy metal functioning as a radiopaque agent;

a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component or another biologic agent;

captopril, enalapril or another angiotensin converting enzyme (ACE) inhibitor;

ascorbic acid, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-aminosteroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant;

a ¹⁴C—

, ³H—

, ¹³¹I—

, ³²P—

or ³⁶S-radiolabelled form or other radiolabelled form of any of the foregoing;

estrogen or another sex hormone;

AZT or other anti polymerases;

acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium, Norvir, Crixivan, or other antiviral agents;

5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123 or other photodynamic therapy agents;

an IgG2 Kappa antibody against Pseudomonas aeruginosa exotoxin A and reactive with A431 epidermoid carcinoma cells, monoclonal antibody against the noradrenergic enzyme dopamine beta-hydroxylase conjugated to saporin or other antibody targeted therapy agents;

gene therapy agents; and

enalapril and other prodrugs;

Proscar®

or other agents for treating benign prostatic hyperplasia (BHP) or a mixture of any of these; and

various forms of small intestine submucosa (SIS).

22. A collapsible filter for introduction into a blood vessel of a patient as set forth in claim 15 wherein the layer of bioactive coating contains about 100 μ

g to about 300 μ

g of drug per 0.001 inch of coating thickness.

16. A collapsible filter for introduction into a blood vessel of a patient, said collapsible filter having a proximal portion, a medial portion and a distal portion, comprising:

an apical hub, in the proximal portion of said filter, having a first or distal end and a second or proximal end;

a plurality of struts having proximal end and distal end portions, the proximal ends of said plurality of struts being secured to the first or distal end of said apical hub and diverging distally and outwardly therefrom, and each of said struts having an outwardly turned hook at their distal ends;

a pair of side elements associated with each of said struts, each side element having a proximal portion and a distal portion, the proximal end of the proximal portions being secured to the first or distal end of said apical hub and diverging distally and outwardly therefrom such that the associated strut lies between the pair of side elements, the distal portion of each side element diverging inwardly toward said associated strut such that the distal ends of the pair of side elements meet and form an eyelet through which the associated strut passes in a sliding relationship, whereby the filter as a whole may be unfolded from a collapsed insertion condition in which the struts and side elements form a narrow bundle for arrangement in a catheter like insertion instrument into an open tulip like filter configuration with the side elements interoposed between the struts;

a deployment and retrieval section secured to and extending proximately from the second or proximal end of said apical hub;

a bioactive coating defining an exterior surface of said filter to prevent the growth of tissue that would interfere with removal of the filter; and

wherein the bioactive coating includes about 0.1 to 10.0 μ

g of bioactive material per 1.0 mm² of a coated surface area of the filter.

17. A collapsible filter for introduction into a blood vessel as set forth in claim 16, wherein:

said bioactive coating defines the exterior surface of the distal end portion of the struts and their hooks to prevent the ingrowth of tissue to and therearound.

18. A collapsible filter for introduction into a blood vessel as set forth in claim 17, wherein:

said bioactive coating defines the exterior surface of said first or distal end of the apical hub and the deployment and retrieval section that is secured to the apical hub to prevent the ingrowth of tissue to and therearound.

19. A collapsible filter for introduction into a blood vessel as set forth in claim 16, wherein:

said bioactive coating defines the entire exterior surface area of the filter to prevent the ingrowth of tissue to and therearound.

20. A collapsible filter for introduction into a blood vessel as set forth in claim 16 wherein:

said bioactive coating is dexamethasone.

21. A collapsible filter for introduction into a blood vessel as set forth in claim 16 wherein:

said bioactive coating is pacilitaxel.

23. A collapsible filter for introduction into a blood vessel of a patient as set forth in claim 16 wherein the layer of bioactive coating includes at least one of heparin, covalent heparin, or another thrombin inhibitor, hirudin, hirulog, argatroban, D-phenylalanyl-L-poly-L-arginyl chloromethyl ketone, or another antithrombogenic agent, or mixtures thereof;

urokinase, streptokinase, a tissue plasminogen activator, or another thrombolytic agent, or mixtures thereof;

a fibrinolytic agent;

a vasospasm inhibitor;

a calcium channel blocker, a nitrate, nitric oxide, a nitric oxide promoter or another vasodilator;

Hytrin®

or other antihypertensive agents;

an antimicrobial agent or antibiotic;

aspirin, ticlopidine, a glycoprotein IIb/IIIa inhibitor or another inhibitor of surface glycoprotein receptors, or another antiplatelet agent;

colchicine or another antimitotic, or another microtubule inhibitor, dimethyl sulfoxide (DMSO), a retinoid or another antisecretory agent;

cytochalasin or another actin inhibitor;

or a remodelling inhibitor;

deoxyribonucleic acid, an antisense nucleotide or another agent for molecular genetic intervention;

methotrexate or another antimetabolite or antiproliferative agent;

tamoxifen citrate, Taxol®

or the derivatives thereof, or other anti-cancer chemotherapeutic materials;

dexamethasone, dexamethasone sodium phosphate, dexamethasone acetate or another dexamethasone derivative, or another anti-inflammatory steroid or non-steroidal antiinflammatory agent;

cyclosporin or another immunosuppressive agent;

trapidal (a PDGF antagonist), angiopeptin (a growth hormone antagonist), angiogenin, a growth factor or an anti-growth factor antibody, or another growth factor antagonist;

dopamine, bromocriptine mesylate, pergolide mesylate or another dopamine agonist;

⁶⁰Co (5.3 year half life), ¹⁹²Ir (73.8 days), ³²P (14.3 days), ¹¹¹In (68 hours), ⁹⁰Y (64 hours), ^99mTc (6 hours) or another radiotherapeutic material;

iodine-containing compounds, barium-containing compounds, gold, tantalum, platinum, tungsten or another heavy metal functioning as a radiopaque agent;

a peptide, a protein, an enzyme, an extracellular matrix component, a cellular component or another biologic agent;

captopril, enalapril or another angiotensin converting enzyme (ACE) inhibitor;

ascorbic acid, alpha tocopherol, superoxide dismutase, deferoxamine, a 21-aminosteroid (lasaroid) or another free radical scavenger, iron chelator or antioxidant;

a ¹⁴C—

, ³H—

, ¹³¹I—

, ³²P—

or ³⁶S-radiolabelled form or other radiolabelled form of any of the foregoing;

estrogen or another sex hormone;

AZT or other anti polymerases;

acyclovir, famciclovir, rimantadine hydrochloride, ganciclovir sodium, Norvir, Crixivan, or other antiviral agents;

5-aminolevulinic acid, meta-tetrahydroxyphenylchlorin, hexadecafluoro zinc phthalocyanine, tetramethyl hematoporphyrin, rhodamine 123 or other photodynamic therapy agents;

an IgG2 Kappa antibody against Pseudomonas aeruginosa exotoxin A and reactive with A431 epidermoid carcinoma cells, monoclonal antibody against the noradrenergic enzyme dopamine beta-hydroxylase conjugated to saporin or other antibody targeted therapy agents;

gene therapy agents; and

enalapril and other prodrugs;

Proscar®

or other agents for treating benign prostatic hyperplasia (BHP) or a mixture of any of these; and

various forms of small intestine submucosa (SIS).

26. A collapsible filter for introduction into a blood vessel of a patient as set forth in claim 16 wherein said bioactive coating includes about 1.0 to 5.0 μ

g of bioactive material per 1.0 mm² of the coated surface area of the filter.

27. A collapsible filter for introduction into a blood vessel of a patient as set forth in claim 26 wherein said bioactive coating includes about 3.0 μ

g of bioactive material per 1.0 mm² of the coated surface area of the filter.

28. A collapsible filter for introduction into a blood vessel of a patient as set forth in claim 16 wherein each of the pair of side elements is a unitary, one-piece component.