Mechanical apparatus and method for dilating and delivering a therapeutic agent to a site of treatment
A mechanical dilatation and medicament delivery device for enlarging a flow passage of a vessel by dilating and delivering a therapeutic agent or medicament to an obstruction in the vessel. The present invention comprises a substantially cylindrically shaped expansion member and includes a means engaged to the expansion member for altering the distance between the proximal end and the distal end of the expansion member thereby transforming the expansion member between a diametrically contracted configuration to diametrically expanded configuration. A therapeutic agent or medicament is coated on either the expansion member, or incorporated into an substrate and then coated on the expansion member.
1 . An apparatus for dilating and delivering a medicament to an obstruction within a vascular segment or a body passageway which comprises:
a catheter having a distal end and a proximal end;
a substantially cylindrical shaped expansion member located on said distal end of said catheter, said expansion member having a first end and a second end, said first end being a distance from said second end;
an altering means engagable to said first end and said second end of said expansion member for altering said first distance therebetween to move said expansion member between a first configuration wherein said expansion member is characterized by a first diameter and a second configuration wherein said expansion member is characterized by a second diameter, said second diameter being greater than said first diameter; and
a therapeutic agent coated on at least a portion of said expansion member.
2 . An apparatus as recited in claim 1 wherein said expansion member defines a flow passageway extending between said first end and said second end of the expansion member.
3 . An apparatus as recited in claim 1 wherein said expansion member comprises a first plurality of flexible elongate elements helically wound in a first direction of rotation and a second plurality of flexible elongate elements helically wound in a second direction of rotation to form a braid.
4 . An apparatus as recited in claim 1 wherein said expansion member is adapted to allow blood perfusion while said expansion member in either in said first diameter or in said second diameter.
5 . An apparatus as recited in claim 1 wherein said therapeutic agent or medicament is incorporated into a non-therapeutic substrate.
6 . An apparatus for dilating and introducing molecules into cells within a vascular segment or a body passageway which comprises:
a catheter having a distal end and a proximal end;
a substantially cylindrical shaped expansion member located on said distal end of said catheter, said expansion member having a first end and a second end, said first end being a distance from said second end;
an altering means engagable to said expansion member for moving said expansion member between a first configuration wherein said expansion member is characterized by a first diameter and a second configuration wherein said expansion member is characterized by a second diameter, said second diameter being greater than said first diameter; and
a medicament coated on at least a portion of said expansion member.
7 . An apparatus as recited in claim 6 wherein said expansion member defines a flow passageway extending between said first end and said second end of the expansion member.
8 . An apparatus as recited in claims 1 or 6 , wherein said therapeutic agent or medicament is an anticoagulant selected from the group consisting of D-Phe-Pro-Arg chloromethyl ketone, an RGD peptide-containing compound, heparin, an antithrombin compound, a platelet receptor antagonist, an anti-thrombin antibody, an anti-platelet receptor antibody, hirudin, hirulog, phe-pro-arg-chloromethyketone (Ppack), Factor VIIa, Factor Xa, aspirin, clopridogrel, ticlopidine, a prostaglandin inhibitor, a platelet inhibitor and a tick anti-platelet peptide, and combinations thereof.
9 . An apparatus as recited in claims 1 or 6 , wherein said therapeutic agent or medicament is a promoter of vascular cell growth selected from the group consisting of a growth factor stimulator, a growth factor receptor agonist, a transcriptional activator, and a translational promoter, and combinations thereof.
10 . An apparatus as recited in claim 1 or 6 wherein said therapeutic agent or medicament is an inhibitor of vascular cell growth selected from the group consisting of a growth factor inhibitor, a growth factor receptor antagonist, a transcriptional repressor, a translational repressor, an antisense DNA, an antisense RNA, synthetic DNA compounds, especially those with backbones that have been modified to inhibit enzymatic degradation (e.g. phosphorothioate compounds and morpholino diamidate compounds), a replication inhibitor, an inhibitory antibody, an antibody directed against growth factors, a bifunctional molecule consisting of a growth factor and a cytotoxin, and a bifunctional molecule consisting of an antibody and a cytotoxin, double stranded DNA, single stranded DNA, single stranded RNA and a double stranded RNA and combinations thereof.
11 . An apparatus as recited in claims 1 or 6 , wherein said therapeutic agent or medicament is selected from the group consisting of a cholesterol-lowering agent, a vasodilating agent, and agents which interfere with endogenous vasoactive mechanisms, estrogen, testosterone, steroid hormones, cortisol, dexamethasone, corticosteroids, thyroid hormones, thyroid hormones analogs, throid hormones antagonist, adrenocorticotrophic hormone, thyroid stimulating hormone, thyroid releasing factor, thyroid releasing factor analogs, thyroid releasing factor antagonists and combinations thereof.
12 . An apparatus as recited in claims 1 or 6 , wherein said therapeutic agent or medicament is a smooth muscle inhibitor selected from the group consisting of an agent that modulates intracellular calcium binding proteins, a receptor blocker for contractile agonists, an inhibitor of the sodium/hydrogen antiporter, a protease inhibitor, a nitrovasodilator, a phosphodiesterase inhibitor, a phenothiazine, a growth factor receptor agonist, an anti-mitotic agent, an immunosuppressive agent, and a protein kinase inhibitor, and combinations thereof.
13 . An apparatus as recited in claim 1 or 6 , wherein said therapeutic agent or medicament is a compound of Paclitaxel, Paclitaxel analogs, Rapamycin, Actinomycin D, Methotrexate, Doxorubicin, cyclophosphamide, and 5-fluorouracil, 6-mercapatopurine, 6-thioguanine, cytoxan, cytarabinoside, cis-platin, chlorambucil, busulfan, and any other drug that can inhibit cell proliferation, and combinations thereof.
14 . An apparatus as recited in claims 1 or 6 , wherein said medicaments are agents that function to stimulate cell growth or cell division.
15 . An apparatus as recited in claims 1 or 6 , where said medicaments are a fibroblast growth factor, endothelial cell growth factor, growth hormone or erythopoeitin.
16 . An apparatus as recited in claim 6 wherein said therapeutic agent or medicament is incorporated into a non-therapeutic substrate.
17 . An apparatus as recited in claim 1 or 6 further comprising a plurality of said therapeutic agents or medicaments coated on at least a portion of said expansion member.
18 . A mechanical dilatation and medicament delivery device comprising:
a catheter having a distal end and a proximal end, said catheter having one or more lumens;
an substantially cylindrically shaped expandable mesh positioned on said distal end adapted to dilate an obstruction in a vessel, said mesh having a first contracted diameter and a second expanded diameter, said second expanded diameter being larger than said first contracted diameter; and
said mechanical dilatation and medicament delivery device being adapted to dilate said obstruction and expose said obstruction to one or more medicaments while allowing blood or bodily fluids to flow through said substantially cylindrically shaped expandable mesh.