ANEURSYM OCCLUSION SYSTEM AND METHOD

• US 20170172581A1
• Filed: 03/06/2017
• Published: 06/22/2017
• Est. Priority Date: 04/07/2006
• Status: Abandoned Application

• Current Assignee: Penumbra, Inc.
• Original Assignee: Penumbra, Inc.
• Inventors: Pons, Stephen, Leynov, Aleksandr, Bose, Arani, Gupta, Vikas, Barry, Dave, Hui, Delilah
• Application Number:
  US15/451,107
• Publication Number:
  US 20170172581A1
• Time in Patent Office: Days
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/1215 comprising additional materials, e.g. thrombogenic, having filaments, having fibers, being coated
• CPC Class Codes: A61F 2/885 comprising a coil including a plurality of spiral or helical sections with alternate directions around a central axis
• CPC Class Codes: A61F 2/91 made from perforated sheet material or tubes, e.g. perforated by laser cuts or etched holes
• CPC Class Codes: A61F 2/915 with bands having a meander structure, adjacent bands being connected to each other
• CPC Class Codes: A61F 2/966 with relative longitudinal movement between outer sleeve and prosthesis, e.g. using a push rod
• CPC Class Codes: A61F 2002/823 Stents, different from stent-grafts, adapted to cover an aneurysm
• CPC Class Codes: A61F 2002/825 having longitudinal struts
• CPC Class Codes: A61F 2002/9505 having retaining means other than an outer sleeve, e.g. male-female connector between stent and instrument
• CPC Class Codes: A61F 2002/9665 with additional retaining means
• CPC Class Codes: A61F 2210/0014 using shape memory or superelastic materials, e.g. nitinol
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0069 cylindrical
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0091 helically-coiled or spirally-coiled, i.e. having a 2-D spiral cross-section
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube

Abstract

An aneurysm occlusion system includes a device positionable within a cerebral blood vessel covering a neck of an aneurysm on the blood vessel. The device includes an expandable tubular element having a lumen surrounded by a sidewall including a plurality of gaps. When expanded, the tubular element includes longitudinal standards arrayed helically in a proximal to distal direction. The standards support struts and the gaps are defined between adjacent struts and are sufficiently large to permit delivery of embolic coils or other embolic materials therethrough.

Claims

1. A system for treatment of intracranial aneurysm comprising:

a device for bridging the neck of an aneurysm of a cerebral vessel, said device comprising a tubular element including a plurality of standards, a plurality of bands connected to the standards, a longitudinal axis, a reduced-profile delivery configuration and a deployed configuration, wherein said standards are oriented at an angle to said longitudinal axis when said tubular element is in said deployed configuration so that the standards and the bands together define a plurality of helical spines;

an introducer for introducing said tubular element into a vessel; and

a delivery device for delivering embolic material into the aneurysm.

2. The system according to claim 1 wherein said angle is between 15°

and 45°

.

3. The system of claim 1 wherein the bands further comprise one or more V-struts, wherein each V-strut comprises a first leg, a second leg that is longer than said first leg, and an apex between said legs.

4. The system of claim 1 wherein said standards comprise a width of between 0.0020 inch and 0.0050 inch.

5. The system of claim 1 wherein said bands further comprise one or more V-struts, wherein each V-strut comprises a first leg, a second leg, and an apex between said legs, said first leg further comprising an S-shaped connector disposed near, but not on, said apex.

6. The system of claim 1 wherein said tubular element comprises shape memory material and said system further comprises a sheath, whereby said tubular element is retained in said low profile delivery configuration, wherein withdrawal of said sheath permits said tubular element to convert to its deployed configuration.

7. The system of claim 6 wherein said tubular element can be returned to its delivery configuration within said sheath.

8. The system of claim 1 wherein said system further comprises a sheath, and said tubular element can be withdrawn into said sheath via said introducer.

9. The system of claim 1 the introducer further comprising a tip comprising a central lumen, one or more legs, and at least one aperture.

10. The system according to claim 9 wherein said first and second standards further comprises at least one bump configured to engage the at least one aperture.

11. A method of manufacture of an intravascular device, said method comprising the steps of:

providing a tube comprising one or more shape memory materials, a longitudinal axis, a proximal end and a distal end;

cutting the tube according to a predetermined pattern, wherein the predetermined pattern defines at least two parallel elongate standards, bands, and gaps between said bands;

applying a circumferential twist to the cut tube to orient the elongate elements at an angle to said longitudinal axis; and

applying a shape memory set to the twisted cut tube.

12. The method according to claim 11 wherein said shape memory material is nitinol.

13. The method according to claim 11 wherein said predetermined pattern defines only two parallel elongate standards.

14. The method according to claim 11 wherein said predetermined pattern further defines a plurality of V-shaped bands having at least one end connected to an elongate standard.

15. The method according to claim 14 wherein said V-shaped bands comprise apexes and S-shaped connectors, wherein said S-connectors are disposed near, but not upon, said apexes.

16. The method according to claim 11 wherein the step of applying a circumferential twist to the cut tube is performed so that at least one of the elongate standards crisscrosses a second elongate standard at the distal end.

17. The method according to claim 11 wherein said angle is between 15°

and 45°

.

18. A method of treating an aneurysm located in a blood vessel of a subject, the method comprising the steps of:

introducing an elongate tubular delivery device into the blood vessel and proximate the aneurysm, the delivery device suitable for delivery of embolic material;

introducing a tubular element for bridging the neck of the aneurysm, the tubular element being radially expandable from a compressed position to an expanded position, having a proximal end, a distal end, a longitudinal axis, at least two elongate standards and a plurality of bands attached thereto, the bands having gaps therebetween and further comprising a first leg, a second leg that is longer than said first leg, and an apex between said first leg and said second leg, the elongate standards arranged helically about the longitudinal axis from the proximal end to the distal end when the tubular element is in the expanded position, the elongate standards and bands together forming a first helical spine and a second helical spine;

bridging a neck of the aneurysm with the tubular element;

permitting the expandable tubular element to expand;

delivering one or more embolic materials to the aneurysm; and

withdrawing the tubular delivery device.