Methods of manufacturing slotted vascular treatment devices

• US 9,179,995 B2
• Filed: 08/28/2013
• Issued: 11/10/2015
• Est. Priority Date: 03/15/2013
• Status: Active Grant

• Current Assignee: Insera Therapeutics, Inc.
• Original Assignee: Insera Therapeutics, Inc.
• Inventors: Janardhan, Vallabh, Janardhan, Vikram
• Primary Examiner(s): Ross, Dana
• Assistant Examiner(s): Bae, Gyounghyun
• Application Number:
  US14/012,913
• Publication Number:
  US 20140265030A1
• Time in Patent Office: 804 Days
• Field of Search: 219/121.7, 21912167-12169, 219/121.72, 219/121.84, 29/33.T, 623/1.1, 623/901
• US Class Current: 1/1
• 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 measureable 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 manufacturing a vascular treatment device, the method comprising:

holding a hypotube using at least one bushing and at least one collet;

cutting a pattern comprising a plurality of kerfs into the hypotube, wherein cutting the pattern comprises;

directing a focused laser beam at the hypotube, the focused laser beam creating a heat impact puddle, the heat impact puddle being less than a width and a length of each of the plurality of kerfs, and

longitudinally and rotationally moving the hypotube in a design such that the focused laser beam cuts the hypotube to form the plurality of kerfs; and

during cutting the pattern, flowing fluid through the hypotube,

wherein holding the hypotube using the at least one bushing and the at least one collet comprises inhibiting motion of the hypotube prior to cutting of the hypotube by the focused laser beam and at least one of reducing sag of the hypotube and maintaining tension on the hypotube as the hypotube is advanced towards the focused laser beam, and wherein longitudinally and rotationally moving the hypotube comprises advancing the hypotube towards the focused laser beam using a hypotube dispenser comprising hypotube clamp and a motor.

2. The method of claim 1, wherein directing the focused laser beam comprises creating the heat impact puddle inward of edges of the plurality of kerfs, and wherein cutting the pattern comprises cutting away the heat impact puddle.

3. The method of claim 1, wherein directing the focused laser beam comprises creating the heat impact puddle at edges of the plurality of kerfs.

4. The method of claim 1, wherein directing the focused laser beam comprises creating the heat impact puddle at corners of the plurality of kerfs.

5. The method of claim 1, wherein the design comprises outlining edges of the plurality of kerfs.

6. The method of claim 1, wherein the design comprises moving the hypotube comprises relatively moving the focused laser beam diagonal to the plurality of kerfs.

7. The method of claim 1, wherein the design comprises a spiral.

8. The method of claim 1, wherein holding the hypotube comprises adjusting a diameter of an aperture of the at least one collet.

9. The method of claim 1, wherein flowing the fluid comprises adjusting a height of a reservoir containing the fluid.

10. The method of claim 1, wherein flowing the fluid comprises adjusting a height of a water inlet gate between a reservoir containing the fluid and the hypotube.

11. The method of claim 1, wherein the width of the kerfs is between about 0.02 mm and about 0.03 mm.

12. The method of claim 1, wherein a ratio of the width of the kerfs to a circumferential thickness of struts at least partially defined by the kerfs is between about 1:

1 and about 2;

1.

13. A method of manufacturing a vascular treatment device, the method comprising:

cutting a pattern into a hypotube, wherein the pattern comprises;

a first pattern of longitudinally-spaced rows each comprising two kerfs and two stems, the two stems in each of the rows of the first pattern circumferentially 180°

apart, the stems of the first pattern offset in a first circumferential direction, and

a second pattern of longitudinally-spaced rows each comprising two kerfs and two stems, the two stems in each of the rows of the second pattern circumferentially 180°

apart, the rows of the second pattern interspersed with the rows of the first pattern, the stems of the second pattern offset in a second circumferential direction opposite the first circumferential direction; and

during cutting the pattern, flowing fluid through the hypotube.

14. The method of claim 13, wherein each of the rows is angled with respect to a longitudinal axis of the hypotube.

15. The method of claim 13, wherein the kerfs in each of the rows of the first pattern and the second pattern have rounded edges.

16. The method of claim 13, wherein a pitch of the longitudinally-spaced rows of the first pattern and the second pattern varies longitudinally along the hypotube.

17. A method of manufacturing a vascular treatment device, the method comprising:

holding a hypotube using at least one bushing and at least one collet;

cutting a pattern comprising a plurality of kerfs into the hypotube, wherein cutting the pattern comprises;

directing a focused laser beam at the hypotube, the focused laser beam creating a heat impact puddle, the heat impact puddle being less than a width and a length of each of the plurality of kerfs, wherein a ratio of the width of the kerfs to a circumferential thickness of struts at least partially defined by the kerfs is between about 1;

1 and about 2;

1, and

longitudinally and rotationally moving the hypotube in a design such that the focused laser beam cuts the hypotube to form the plurality of kerfs; and

during cutting the pattern, flowing fluid through the hypotube.

18. The method of claim 17, wherein directing the focused laser beam comprises creating the heat impact puddle inward of edges of the plurality of kerfs, and wherein cutting the pattern comprises cutting away the heat impact puddle.

19. The method of claim 17, wherein directing the focused laser beam comprises creating the heat impact puddle at edges of the plurality of kerfs.

20. The method of claim 17, wherein directing the focused laser beam comprises creating the heat impact puddle at corners of the plurality of kerfs.

21. The method of claim 17, wherein the design comprises outlining edges of the plurality of kerfs.

22. The method of claim 17, wherein the design comprises moving the hypotube comprises relatively moving the focused laser beam diagonal to the plurality of kerfs.

23. The method of claim 17, wherein the design comprises a spiral.

24. The method of claim 17, wherein holding the hypotube comprises adjusting a diameter of an aperture of the at least one collet.

25. The method of claim 17, wherein flowing the fluid comprises adjusting a height of a reservoir containing the fluid.

26. The method of claim 17, wherein flowing the fluid comprises adjusting a height of a water inlet gate between a reservoir containing the fluid and the hypotube.

27. The method of claim 17, wherein the width of the kerfs is between about 0.02 mm and about 0.03 mm.