DEVICES AND METHODS FOR TREATING VENOUS DISEASES

• US 20120022579A1
• Filed: 07/25/2011
• Published: 01/26/2012
• Est. Priority Date: 07/23/2010
• Status: Active Grant

• Current Assignee: Vascular Development Corporation LLC
• Original Assignee: Nfinium Vascular Technologies, LLC
• Inventors: Fulton, Richard E.
• Granted Patent: US 9,561,094 B2
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/221 Gripping devices in the form of loops or baskets for gripping calculi or similar types of obstructions surgical snare instruments A61B17/32056
• CPC Class Codes: A61B 17/3207 Atherectomy devices working by cutting or abrading; Similar devices specially adapted for non-vascular obstructions A61B17/32037 takes precedence; endoscopic cutting instruments A61B17/320016
• CPC Class Codes: A61B 17/32075 Pullback cutting; combined forward and pullback cutting, e.g. with cutters at both sides of the plaque
• CPC Class Codes: A61B 2017/2212 having a closed distal end, e.g. a loop
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/2412 with soft flexible valve members, e.g. tissue valves shaped like natural valves check valves with flexible valve members in general F16K15/14
• CPC Class Codes: A61F 2/2418 Scaffolds therefor, e.g. support stents
• CPC Class Codes: A61F 2/2475 Venous valves
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2220/0008 Fixation appliances for connecting prostheses to the body
• CPC Class Codes: A61F 2220/0016 with sharp anchoring protrusions, e.g. barbs, pins, spikes
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0065 toroidal, e.g. ring-shaped, doughnut-shaped
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2250/0067 Means for introducing or releasing pharmaceutical products into the body

Abstract

The present invention relates generally to a medical device and method of use, and more specifically to a method and apparatus with coaxial components used to treat venous diseases. The apparatus according to various embodiments operates as an inferior vena cava filter, a clot puller, a clot shredder, and as a prosthetic venous valve.

Claims

1. A venous treatment apparatus comprising:

a device having a proximal portion, a distal portion, a central portion, and an inner sheath substantially fitting within an outer sheath, said central portion having an expansile braid mechanism that is associated with the distal portion and outer sheath, said expansile braid mechanism deployable by axial movement of said inner sheath within said outer sheath so as to engage said central portion against a venous vessel when said venous treatment apparatus is inserted within said venous vessel in a manner that positions said expansile braid mechanism wherein fluid flows in a direction from said distal portion toward said proximal portion.

2. The apparatus according to claim 1, wherein said expansile braid mechanism is detachable.

3. The apparatus according to claim 1, wherein said expansile braid mechanism is configured to substantially capture particles within said venous vessel.

4. The apparatus according to claim 1, wherein said device has a mechanism to deliver to the venous vessel at least one of a medicament and a fluid.

5. The apparatus according to claim 1, wherein said expansile braid mechanism is configured to occlude said flow within said venous vessel.

6. The apparatus according to claim 1, wherein said expansile braid mechanism is configured to substantially break particles to axial dimension at or below 2 mm within said venous vessel.

7. The apparatus according to claim 1, wherein said expansile braid mechanism is configured to substantially remove particles within said venous vessel.

8. The apparatus according to claim 1, wherein said expansile braid mechanism comprises an elastomeric coating.

9. The apparatus according to claim 1, wherein said distal portion has an extended distal portion and an extended proximal portion and is configured to insert from a first surgical site and exit from a second surgical site.

10. The apparatus according to claim 9, wherein said first surgical site is selected from the group consisting of:

the jugular vein, the femoral vein, the subclavian vein, and the axillary vein; and

the second surgical site is the popliteal vein.

11. The apparatus according to claim 9, wherein the extended distal portion is selected from the group consisting of:

an annular expansile element, a stent-like structure, a spiral wire-like structure, and a guide wire.

12. The apparatus according to claim 11, wherein said extended distal portion is substantially covered by a hydrogel.

13. The apparatus according to claim 1, further comprising a spacer tube coaxially fitted over said inner sheath that inhibits deformity of said expansile braid mechanism.

14. A venous treatment apparatus comprising:

a device adapted to be inserted within a venous vessel, said device having a proximal portion, a distal portion, a central portion, and an inner sheath substantially fitting within an outer sheath, said central portion having an expansile braid mechanism that is associated with the distal portion and outer sheath, said expansile braid mechanism deployable by axial movement of said inner sheath within said outer sheath so as to engage said central portion against a venous vessel when said venous treatment apparatus is inserted within said venous vessel, said distal portion comprising a valve mechanism with a reversibly sealable opening.

15. The apparatus according to claim 14, wherein said valve mechanism has a substantially duck bill shape.

16. The apparatus according to claim 14, wherein said expansile braid mechanism has a non-proliferative drug coating.

17. The apparatus according to claim 14, wherein said expansile braid has biodegradable wires or members.

18. The apparatus according to claim 14, wherein said expansile braid has a low-density braid.

19. The apparatus according to claim 14, wherein said valve mechanism is an elastomeric polymer.

20. The apparatus according to claim 14, wherein said valve mechanism comprises a means to inhibit at least one of thrombogenicity, fibin deposition, and infection.

21. The apparatus according to claim 14, wherein at least one of said valve mechanism and said expansile braid is comprised of at least 80 percent hydrogel.

22. A method of treating a target site within a venous vessel through which fluid flows, comprising:

a) providing a venous treatment apparatus comprising a device having a proximal portion, a distal portion, a central portion, and an inner sheath substantially fitting within an outer sheath, said central portion further having an expansile braid mechanism associated with the distal portion and outer sheath;

b) inserting said apparatus into a venous vessel so that fluid flows in a direction from said distal portion toward said proximal portion;

c) deploying said expansile braid mechanism by axially moving said inner sheath within said outer sheath so as to expand a diameter of said braid mechanism so that said diameter contacts the venous vessel; and

d) performing an intervention selected from the group consisting of;

capturing particles within said body channel, removing particles within said body channel, occluding said flow within said body channel, and breaking-apart particles within said body channel.

23. The method according to claim 22, further comprising detaching said expansile braid mechanism portion.

24. A method of treating a target site within a venous vessel through which fluid flows, comprising the steps of:

a) providing an apparatus;

b) inserting a funnel catheter into said venous vessel from a first surgical site, wherein said funnel catheter is positioned cephalic to said target site;

c) inserting said apparatus into said venous vessel from a second surgical site, said apparatus comprising a work element and configured to insert from a first surgical site and exit from a second surgical site;

d) passing said apparatus through said funnel catheter and exiting from said first surgical site;

e) deploying said work element into said venous vessel; and

f) performing an intervention selected from the group consisting of;

capturing particles within said venous vessel, removing particles within said venous vessel, occluding said flow within said venous vessel, and breaking-apart particles within said venous vessel.

25. The method according to claim 24, wherein the apparatus comprises a device having a proximal portion, a distal portion, a central portion, and an inner sheath substantially fitting within an outer sheath, said central portion engaged with said work element, said work element comprising an expansile braid mechanism associated with the distal portion and outer sheath, wherein said distal portion further comprises an extended distal portion and an extended proximal portion;

and during said deploying step e), said expansile braid mechanism is deployed by axially moving said inner sheath within said outer sheath so as to engage said expansile braid mechanism against said venous vessel when said apparatus is inserted within said venous vessel.

26. The method according to claim 25, further comprising detaching said expansile braid mechanism portion.