Devices and methods for treating venous diseases

• US 9,561,094 B2
• Filed: 07/25/2011
• Issued: 02/07/2017
• 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.
• Primary Examiner(s): Yabut, Diane
• Application Number:
  US13/190,416
• Publication Number:
  US 20120022579A1
• Time in Patent Office: 2,024 Days
• Field of Search: 606/200, 606/151, 606/191, 606/198, 606/104, 623/1, 623/1.23, 604/194, 607/122
• US Class Current: 1/1
• 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 comprising an inner sheath and an outer sheath, the outer sheath having a proximal portion, an extended distal portion having a length between 50 cm and 400 cm, and a central portion and the inner sheath substantially fitting within the outer sheath,

said central portion of the outer sheath including an expansile braid mechanism having a distal end connected to the extended distal portion of the outer sheath and having a proximal end connected to the proximal portion of the 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,

said expansile braid mechanism being at least partially porous to thrombus and comprising woven strands having one or more of a weave pattern density, strand thickness, adhesiveness, or strand diameter, such that, upon contact with said thrombus, the expansile braid mechanism substantially breaks the thrombus into particles.

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 flow within said venous vessel.

6. The apparatus according to claim 1, wherein said expansile braid mechanism is configured to substantially break the thrombus particles to an 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 further comprises an elastomeric coating.

9. 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.

10. The apparatus according to claim 1, wherein said extended distal portion has a length of between 50 cm to 200 cm.

11. The apparatus according to claim 1, wherein said extended distal portion has a length of between 70 cm to 180 cm.

12. The apparatus according to claim 1, wherein said extended distal portion has a length of between 90 cm to 150 cm.

13. A venous treatment apparatus comprising:

a device comprising an inner sheath and an outer sheath, the outer sheath having an extended proximal portion, an extended distal portion having a length between 50 cm and 400 cm, and a central portion and the inner sheath substantially fitting within the outer sheath,

said central portion of the outer sheath including an expansile braid mechanism having a distal end connected to said extended distal portion of the outer sheath and having a proximal end connected to said proximal portion of the 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 said extended distal portion is configured to be inserted from a first vascular entry access site and exit from a second vascular entry access site, and wherein an

overall length of said device is sufficient to allow user manipulation of said inner sheath and said outer sheath from either or both access sites.

14. The apparatus according to claim 13, wherein said first vascular entry access site is selected from the group consisting of:

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

the second vascular entry access site is the popliteal vein.

15. The apparatus according to claim 13, 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.

16. The apparatus according to claim 15, wherein said extended distal portion is substantially covered by a hydrogel.

17. The apparatus according to claim 13, wherein said extended distal portion has a length of between 70 cm to 200 cm.

18. The apparatus according to claim 13, wherein said extended distal portion includes a distal tip configured to be inserted into a funnel tipped catheter in said venous vessel.

19. 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 comprising an inner sheath and an outer sheath, the outer sheath having a proximal portion, an extended distal portion having a length between 50 cm and 400 cm, and a central portion and the inner sheath substantially fitting within the outer sheath, said central portion of the outer sheath further having an expansile braid mechanism having a distal end connected to said extended distal portion of the outer sheath,

b) 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 a venous vessel; and

c) translating said expansile braid mechanism in said venous vessel to contact thrombus therein and to break apart the thrombus into particles.

20. The method according to claim 19 further comprising positioning a funnel catheter in said venous vessel, and wherein breaking-apart particles comprises drawing the expansile braid mechanism toward said funnel catheter and cutting said particles with said expansile braid mechanism.