Vascular treatment devices and methods

• US 9,314,324 B2
• Filed: 09/08/2015
• Issued: 04/19/2016
• 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): MILES, JONATHAN WADE
• Application Number:
  US14/848,079
• Publication Number:
  US 20150374483A1
• Time in Patent Office: 224 Days
• US Class Current: 1/1
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 17/12163 having a string of elements connected to each other
• 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 2017/00137 Details of operation mode
• CPC Class Codes: A61B 2017/00154 pulsed
• CPC Class Codes: A61B 2017/00181 Means for setting or varying the pulse energy
• CPC Class Codes: A61B 2017/00199 with a console, e.g. a control panel with a display
• 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 2017/22001 : 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 2090/061 : for measuring dimensions, e.g. length
• CPC Class Codes: A61B 2090/3966 : Radiopaque markers visible in an X-ray image
• CPC Class Codes: A61B 2217/005 : with suction drainage system
• CPC Class Codes: A61B 90/39 : Markers, e.g. radio-opaque or breast lesions markers
• CPC Class Codes: A61F 2/012 : Multiple filtering units
• 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 2/07 : Stent-grafts
• CPC Class Codes: A61F 2/90 : characterised by a net-like or mesh-like structure
• CPC Class Codes: A61F 2002/016 : made from wire-like elements
• CPC Class Codes: A61F 2002/018 : made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2002/061 : provided with means for allowing access to secondary lumens
• CPC Class Codes: A61F 2002/823 : Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2210/0014 : using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2250/0023 : differing in porosity
• CPC Class Codes: A61M 1/74 : Suction control underwater drainage A61M1/61
• CPC Class Codes: A61M 1/75 : Intermittent or pulsating suction A61M1/63, A61M1/772 take precedence
• 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 1/87 : Details of the aspiration tip, not otherwise provided for
• CPC Class Codes: A61M 2025/0042 : Microcatheters, cannula or the like having outside diameters around 1 mm or less
• CPC Class Codes: A61M 2025/0681 : Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• 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 1/02 : made from particular materials
• CPC Class Codes: D04C 1/06 : Braid or lace serving particular purposes
• CPC Class Codes: D04C 3/40 : for making tubular braids by circulating strand supplies around braiding centre at equal distances
• CPC Class Codes: D04C 3/48 : Auxiliary devices
• CPC Class Codes: D10B 2401/046 : Shape recovering or form memory
• 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 devices and methods include a woven structure including a plurality of bulbs that may be self-expanding, a hypotube, for example including interspersed patterns of longitudinally spaced rows of kerfs, and a bonding zone between the woven structure and the hypotube. The woven structure may include patterns of radiopaque filaments measureable under x-ray. Structures may be heat treated to include various shapes at different temperatures. The woven structure may be deployable to implant in a vessel. A catheter may include a hypotube including interspersed patterns of longitudinally spaced rows of kerfs and optionally a balloon. Laser cutting systems may include fluid flow systems.

Claims

1. A device for treating a thrombus in a vessel, the device comprising:

a distal portion comprising a plurality of wires woven to form a textile structure expandable from a collapsed configuration to an expanded configuration,

the textile structure comprising, in the expanded configuration;

a first bulb,

a second bulb distal to the first bulb, the first bulb and the second bulb having a first diameter,

a first neck longitudinally between the first bulb and the second bulb,

a third bulb distal to the second bulb,

a second neck longitudinally between the second bulb and the third bulb,

a fourth bulb distal to the third bulb, the third bulb and the fourth bulb having a second diameter smaller than the first diameter,

a third neck longitudinally between the third bulb and the fourth bulb,

a fifth bulb distal to the fourth bulb,

a fourth neck longitudinally between the fourth bulb and the fifth bulb,

a sixth bulb distal to the fifth bulb;

the fifth bulb and the sixth bulb having a third diameter smaller than the second diameter, and

a fifth neck longitudinally between the fifth bulb and the sixth bulb;

the plurality of wires comprising;

a plurality of shape-memory wires, and

a plurality of radiopaque wires;

a proximal portion including a tubular member, the tubular member comprising;

a wire; and

a hypotube comprising a lumen, the hypotube distal to the wire,

wherein a portion of the wire is coupled inside the lumen of the hypotube; and

a bonding zone coupling the distal portion and the proximal portion.

2. The device of claim 1, wherein the textile structure further comprises a plurality of bulbs, the plurality of bulbs at least one of proximal to, distal to, and between the first, second, third, fourth, fifth, and sixth bulbs.

3. The device of claim 1, wherein the distal portion is hollow.

4. The device of claim 1, wherein the distal portion comprises a free distal end.

5. A device for treating a thrombus in a vessel, the device comprising:

a first portion comprising a plurality of wires woven to form a textile structure expandable from a collapsed configuration to an expanded configuration,

the textile structure comprising, in the expanded configuration;

four to twenty self-expanding bulbs, wherein the four to twenty self-expanding bulbs comprises;

a first bulb;

a second bulb distal to the first bulb, the first bulb and the second bulb having a first diameter;

a third bulb distal to the second bulb; and

a fourth bulb distal to the third bulb, the third bulb and the fourth bulb having a second diameter smaller than the first diameter;

a plurality of necks,

pairs of the four to twenty self-expanding bulbs spaced along a longitudinal axis of the textile structure by a neck of the plurality of necks,

the plurality of wires comprising shape-memory wires;

a second portion including a tubular member; and

a bonding zone coupling the first portion and the second portion.

6. The device of claim 5, wherein the tubular member comprises:

a wire; and

a hypotube comprising a lumen, the hypotube distal to the wire,

wherein a portion of the wire is coupled inside the lumen of the hypotube.

7. The device of claim 5, wherein the tubular member comprises a plurality of different austenitic finish temperatures along a longitudinal axis of the tubular member.

8. The device of claim 5, wherein the first portion is hollow.

9. The device of claim 5, wherein the first portion comprises a free distal end.

10. A device for treating a thrombus in a vessel, the device comprising:

a first portion comprising a plurality of wires woven to form a textile structure expandable from a collapsed configuration to an expanded configuration,

the textile structure comprising, in the expanded configuration;

a plurality of self-expanding bulbs, and

a plurality of necks,

pairs of the plurality of self-expanding bulbs spaced along a longitudinal axis of the textile structure by a neck of the plurality of necks,

a second portion including a tubular member,

the tubular member comprising;

a wire; and

a hypotube comprising a lumen, the hypotube distal to the wire,

wherein a distal end of the wire is coupled inside the lumen at a proximal end of the hypotube; and

a bonding zone coupling the first portion and a distal end of the hypotube.

11. The device of claim 10, wherein the plurality of self-expanding bulbs comprises:

a first bulb;

a second bulb distal to the first bulb, the first bulb and the second bulb having a first diameter;

a third bulb distal to the second bulb; and

a fourth bulb distal to the third bulb, the third bulb and the fourth bulb having a second diameter smaller than the first diameter.

12. The device of claim 10, wherein the plurality of self-expanding bulbs comprises:

a first bulb;

a second bulb distal to the first bulb, the first bulb and the second bulb having a first diameter;

a third bulb distal to the second bulb;

a fourth bulb distal to the third bulb, the third bulb and the fourth bulb having a second diameter smaller than the first diameter; and

a fifth bulb distal to the fourth bulb, the fifth bulb having a third diameter smaller than the second diameter.

13. The device of claim 10, wherein the plurality of self-expanding bulbs comprises:

a first bulb;

a second bulb distal to the first bulb, the first bulb and the second bulb having a first diameter;

a third bulb distal to the second bulb;

a fourth bulb distal to the third bulb, the third bulb and the fourth bulb having a second diameter smaller than the first diameter;

a fifth bulb distal to the fourth bulb; and

a sixth bulb distal to the fifth bulb, the fifth bulb and the sixth bulb having a third diameter smaller than the second diameter.

14. The device of claim 10, wherein the textile structure comprises:

a first shape at a first temperature,

wherein the first shape comprises a spiral;

a second shape at a second temperature higher than the first temperature,

wherein the second shape comprises the expanded configuration; and

a third shape comprising stress-induced martensite,

the third shape different than the first shape and the second shape,

wherein the textile structure is configured to self-expand from the third shape to the second shape upon deployment from a sheath, and

wherein the textile structure is configured to transform from the second shape to the first shape upon exposure to the first temperature or lower.

15. The device of claim 10, wherein the tubular member comprises a plurality of different austenitic finish temperatures along a longitudinal axis of the tubular member.

16. The device of claim 10, wherein the tubular member comprises a plurality of different shape sets along a longitudinal axis of the tubular member.

17. The device of claim 10, wherein the hypotube has a longitudinal axis and comprises:

a first pattern of longitudinally-spaced rows each including two kerfs and two stems, the two stems in each of the rows of the first pattern circumferentially opposite, the stems of sequential said rows of the first pattern offset in a first circumferential direction; and

a second pattern of longitudinally-spaced rows each including two kerfs and two stems, the two stems in each of the rows of the second pattern circumferentially opposite, the rows of the second pattern singly alternatingly interspersed with the rows of the first pattern, the stems of sequential said rows of the second pattern offset in a second circumferential direction opposite the first circumferential direction.

18. The device of claim 10, wherein the plurality of bulbs comprises four to ten bulbs.

19. The device of claim 10, wherein the first portion is hollow.

20. The device of claim 10, wherein the first portion comprises a free distal end.