Two-way shape memory vascular treatment methods

• US 8,845,678 B1
• Filed: 08/28/2013
• Issued: 09/30/2014
• Est. Priority Date: 07/29/2013
• Status: Active Grant

• Current Assignee: Insera Therapeutics, Inc.
• Original Assignee: Insera Therapeutics, Inc.
• Inventors: Janardhan, Vallabh, Janardhan, Vikram
• Primary Examiner(s): Nguyen, Tuan V
• Assistant Examiner(s): Nguyen, Tin
• Application Number:
  US14/012,866
• Time in Patent Office: 398 Days
• Field of Search: 606/200, 606/159, 623/1.15, 623/1.18, 623/1.3, 623/1.11, 623/1.34, 623 2364- 2366
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12122 within the heart for closing a cardiac septal defect A61B17/0057
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/22 Implements for squeezing-off ulcers or the like on the inside of inner organs of the body; Implements for scraping-out cavities of body organs, e.g. bones; Calculus removers; Calculus smashing apparatus; Apparatus for removing obstructions in blood vessels, not otherwise provided for dilators A61M29/00
• CPC Class Codes: A61B 17/22031 Gripping instruments, e.g. forceps, for removing or smashing calculi A61B17/221 takes precedence
• CPC Class Codes: A61B 17/22032 having inflatable gripping elements balloon catheters A61M25/10
• 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 17/32056 Surgical snare instruments for removing or smashing calculi A61B2017/2212; tonsillotomes A61B17/26
• 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 2017/00526 Methods of manufacturing
• CPC Class Codes: A61B 2017/00575 for closure at remote site, e.g. closing atrial septum defects
• CPC Class Codes: A61B 2017/00592 Elastic or resilient implements
• CPC Class Codes: A61B 2017/00606 Implements H-shaped in cross-section, i.e. with occluders on both sides of the opening
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22001 Angioplasty, e.g. PCTA
• CPC Class Codes: A61B 2017/22002 preventing restenosis
• CPC Class Codes: A61B 2017/22034 for gripping the obstruction or the tissue part from inside
• CPC Class Codes: A61B 2017/22035 for retrieving or repositioning foreign objects
• CPC Class Codes: A61B 2017/22067 : Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/011 : Instruments for their placement or removal
• CPC Class Codes: A61F 2002/018 : made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61M 1/74 : Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/84 : Drainage tubes; Aspiration tips for negative pressure wound therapy A61M1/90; for surgical cutting instruments A61B17/32
• CPC Class Codes: A61M 2025/0042 : Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2202/06 : Solids
• CPC Class Codes: A61M 2207/10 : Device therefor
• CPC Class Codes: A61M 2210/12 : Blood circulatory system
• CPC Class Codes: A61M 25/0023 : by the form of the lumen, e.g. cross-section, variable diameter
• CPC Class Codes: A61M 25/10 : Balloon catheters A61M25/0125 takes precedence; embolectomy A61B17/22032; retractors A61B17/02; inflatable balloons for placing stents or stent-grafts A61F2/958 ; stomach balloons for treatment of obesity A61F5/0003; oesophagal tubes A61J15/00
• CPC Class Codes: A61M 29/00 : Dilators with or without means for introducing media, e.g. remedies instruments for performing visual medical inspections of cavities or tubes of the body A61B1/00
• CPC Class Codes: B23K 26/083 : Devices involving movement of the workpiece in at least one axial direction
• CPC Class Codes: B23K 26/14 : using a fluid stream, e.g. a jet of gas, in conjunction with the laser beam; Nozzles therefor B23K26/12 takes precedence
• CPC Class Codes: B23K 26/142 : for the removal of by-products
• CPC Class Codes: B23K 26/1435 : involving specially adapted flow control means
• CPC Class Codes: B23K 26/146 : the fluid stream containing a liquid
• CPC Class Codes: B23K 26/20 : Bonding soldering by means of radiant energy B23K1/005; joining of preformed plastics parts by heating using laser beam B29C65/16
• CPC Class Codes: B23K 26/38 : by boring or cutting
• CPC Class Codes: B26F 3/004 : by means of a fluid jet methods for use of abrasive blasting for cutting B24C1/045; guns for abrasive fluid jets B24C5/02; perforating by non-mechanical means, e.g. by fluid jet B26F1/26
• CPC Class Codes: D04C 1/06 : Braid or lace serving particular purposes
• CPC Class Codes: D04C 1/12 : Cords, lines, or tows
• CPC Class Codes: D04C 3/48 : Auxiliary devices
• CPC Class Codes: D10B 2403/0333 : with tubular portions of variable diameter or distinct axial orientation
• CPC Class Codes: D10B 2509/06 : Vascular grafts; stents
• CPC Class Codes: Y10T 137/8376 : Combined
• CPC Class Codes: Y10T 137/85954 : Closed circulating system
• CPC Class Codes: Y10T 156/10 : Methods of surface bonding and/or assembly therefor
• CPC Class Codes: Y10T 29/49913 : by constricting outer annulus
• CPC Class Codes: Y10T 29/49995 : Shaping one-piece blank by removing material
• CPC Class Codes: Y10T 82/2521 : Bar feeder

Abstract

Vascular treatment and methods include a plurality of self-expanding bulbs and a hypotube including interspersed patterns of longitudinally spaced rows of kerfs. Joints between woven structures and hypotubes include solder. Woven structures include patterns of radiopaque filaments measurable under x-ray. Structures are heat treated to include at least shapes at different temperatures. A catheter includes a hypotube including interspersed patterns of longitudinally spaced rows of kerfs. Heat treating systems include a detachable flange. Laser cutting systems include a fluid flow system.

Claims

1. A method of treating a thrombus in a vessel, the method comprising:

advancing a microcatheter in the vessel comprising crossing a distal end of the thrombus with a distal end of the microcatheter;

after advancing the microcatheter, inserting a thrombectomy device in a radially compressed state into the microcatheter, the thrombectomy device comprising a plurality of wires woven to form a textile fabric comprising;

a first shape upon advancing out of the microcatheter, and

a second shape upon exposure to a temperature between about 10°

C. and about 18°

C., the second shape different than the first shape;

after inserting the thrombectomy device into the microcatheter, advancing the thrombectomy device in the vessel and through the microcatheter proximate to the distal end of the microcatheter;

after advancing the thrombectomy device, maintaining a location of a proximal portion of the thrombectomy device while proximally retracting the microcatheter, wherein upon advancing out the microcatheter the textile fabric changes from the radially compressed shape to the first shape;

after retracting the microcatheter, injecting fluid to expose the textile fabric to the temperature, wherein, upon exposure to the temperature, the textile fabric changes from the first shape to the second shape;

while the textile structure is in the second shape, torsionally rasping the thrombectomy device; and

after torsionally rasping the thrombectomy device, retracting at a similar rate the microcatheter and the proximal portion of the thrombectomy device.

2. The method of claim 1, wherein the first shape comprises a plurality of bulbs and the second shape comprises a spiral.

3. The method of claim 1, wherein the textile fabric comprises a third shape upon exposure to a second temperature higher than the temperature, the third shape different than the first shape and the second shape.

4. The method of claim 3, wherein the first shape comprises an expanded cylinder, the second shape comprises a spiral, and the third shape comprises a plurality of bulbs.

5. The method of claim 3, wherein the second temperature is about 37°

C.

6. The method of claim 1, wherein torsionally rasping the thrombectomy device comprises at least one of removing portions of the thrombus attached to an endothelium wall, entrapping the thrombus in the radially expanded distal portion of the thrombectomy device, and collecting emboli in the radially expanded distal portion of the thrombectomy device.

7. The method of claim 1, wherein the vessel comprises a blood vessel in a brain or a blood vessel in a leg.

8. A method of treating a thrombus in a vessel, the method comprising:

advancing a thrombectomy device in a radially compressed state in the vessel and through a microcatheter until the thrombectomy device is proximate to a distal end of the microcatheter and a distal end of the thrombus, the thrombectomy device comprising a plurality of wires woven to form a textile fabric comprising;

a first shape upon advancing out of the microcatheter,

a second shape upon exposure to a temperature, the second shape different than the first shape, and

a third shape upon exposure to a second temperature different than the temperature, the third shape different than the first shape and the second shape;

after advancing the thrombectomy device, maintaining a location of a proximal portion of the thrombectomy device while proximally retracting the microcatheter, wherein upon being unsheathed from the microcatheter the textile fabric changes from the radially compressed shape to the first shape and wherein upon being exposed to the temperature the textile fabric changes from the first shape to the second shape;

entrapping the thrombus in the textile fabric in the second shape;

exposing the textile fabric to the second temperature, wherein upon being exposed to the second temperature the textile fabric changes from the second shape to the third shape; and

entrapping the thrombus in the textile fabric in the third shape.

9. The method of claim 8, wherein the first shape comprises a cylinder and the second shape comprises a plurality of bulbs.

10. The method of claim 9, wherein the second shape comprises at least two of the plurality of bulbs having different outer diameters, different shapes, or different outer diameters and different shapes.

11. The method of claim 9, wherein the second shape is tapered.

12. The method of claim 9, wherein the second shape comprises at least two of the plurality of bulbs separated by a neck.

13. The method of claim 8, wherein the first shape comprises a cylinder and the second shape comprises a spiral.

14. The method of claim 8, wherein entrapping the thrombus comprises torsionally rasping the thrombectomy device.

15. The method of claim 8, wherein the vessel comprises a blood vessel in a brain or a blood vessel in a leg.

16. A method of treating a vessel, the method comprising:

providing a device configured to be advanced in a vessel and through a microcatheter in a radially compressed state, the device comprising;

a first shape in the radially compressed state in the microcatheter,

a second shape upon expansion of the device out of the microcatheter,

a third shape upon exposure to a first temperature, the third shape different than the first shape and the second shape, and

a fourth shape upon exposure to a second temperature higher than the first temperature, the fourth shape different than the first shape, the second shape, and the third shape;

wherein the shapes of the device facilitate treatment of the vessel.

17. The method of claim 16, wherein the device comprises a textile structure.

18. The method of claim 16, wherein the device comprises a laser cut structure.

19. The method of claim 16, wherein at least one of the third shape and the fourth shape is non-cylindrical.