ANEURYSM OCCLUSION SYSTEM AND METHOD

• US 20130261730A1
• Filed: 05/31/2013
• Published: 10/03/2013
• Est. Priority Date: 04/07/2006
• Status: Active Grant

• Current Assignee: Penumbra, Inc.
• Original Assignee: Penumbra, Inc.
• Inventors: Bose, Arani, Gupta, Vikas, Barry, Dave, Hui, Delilah, Pons, Stephen, Leynov, Aleksandr
• Granted Patent: US 9,615,832 B2
• Time in Patent Office: Days
• US Class Current: 623/1.12
• 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. An intravascular device comprising:

a tubular element that is radially expandable from a compressed position to an expanded position, said tubular element comprising a wall, a proximal end, a distal end and a central portion therebetween;

the tubular element further comprising at least two elongate standards extending in a helical fashion along the wall from the proximal end to the distal end when the tubular element is in the expanded position; and

the tubular element further comprising a first plurality of bands including at least one end connected to a first elongate standard, wherein the first elongate standard and the first plurality of bands together define a first helical spine, and a second plurality of bands including at least one end connected to a second elongate standard, wherein the second elongate standard and the second plurality of bands together define a second helical spine.

2. The intravascular device according to claim 1 wherein at the proximal end, a first standard is disposed along a first side of the wall, and a second standard is disposed along an opposing side of the wall, and near the distal end, the first standard crisscrosses the second standard.

3. The intravascular device according to claim 1 wherein said tubular element comprises a generally oval cross section near said proximal end and said distal end, and a generally circular cross section near said central portion.

4. The intravascular device according to claim 1 wherein said bands comprise a V-shape.

5. The intravascular device according to claim 4 wherein said V-shaped bands further comprise S-shaped connecting members.

6. The intravascular device according to claim 5 wherein said V-shaped bands comprise apexes and said S-shaped connecting members are disposed near said apexes, but not upon said apexes.

7. The intravascular device according to claim 1 wherein said tubular element is cut from a length of tubing comprising shape memory material according to a pattern, and wherein in said pattern, the elongate standards extend parallel to one another from the proximal end to the distal end.

8. The intravascular device according to claim 1 wherein said tubular element has a longitudinal axis and at the least two elongate standards are oriented in opposite directions at angles of between 15°

and 45°

to said longitudinal axis when said tubular element is in said expanded position.

9. The intravascular device according to claim 1 wherein in addition to said first and second helical spines, said wall is defined by said bands.

10. The intravascular device according to claim 1 wherein said device comprises only two elongate standards.

11. 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.

12. The system according to claim 11 wherein said angle is between 15°

and 45°

.

13. The system of claim 11 wherein the bands further comprise one or more S-shaped connectors.

14. The system of claim 11 wherein said standards comprise a width of between 0.0020 inch and 0.0050 inch.

15. The system of claim 11 wherein said tubular element comprises shape memory material and reversibly converts between said delivery configuration and said deployed configuration.

16. The system of claim 11 wherein said system further comprises a sheath, whereby said tubular element is retained in said low profile delivery configuration, and wherein withdrawal of said sheath permits said tubular element to convert to its deployed configuration.

17. The system of claim 16 wherein said tubular element can be returned to its delivery configuration within said sheath.

18. The system of claim 11 wherein said system further comprises a sheath, and said tubular element can be withdrawn into said sheath via said introducer.

19. The system of claim 11, the introducer further comprising a tip comprising a central lumen, one or more legs, and at least one aperture.

20. The system according to claim 19 wherein said first and second standards further comprises at least one bump configured to engage the at least one aperture.

21. 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;

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.

22. The method according to claim 21 wherein said shape memory material is nitinol.

23. The method according to claim 21 wherein said predetermined pattern defines only two parallel elongate standards.

24. The method according to claim 21 wherein said predetermined pattern further defines a plurality of V-shaped bands having at least one end connected to an elongate standard.

25. The method according to claim 24 wherein said V-shaped bands comprise apexes and S-shaped connectors, wherein said S-connectors are disposed near, but not upon, said apexes.

26. The method according to claim 21 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.

27. The method according to claim 21 wherein said angle is between 15°

and 45°

.

28. 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, and a longitudinal axis, and at least two elongate standards and a plurality of bands attached thereto, 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.