Devices and methods for treating vascular malformations

• US 20020169473A1
• Filed: 03/25/2002
• Published: 11/14/2002
• Est. Priority Date: 06/02/1999
• Status: Abandoned Application

• Current Assignee: Stryker Corporation
• Original Assignee: Concentric Medical, Inc. (Stryker Corporation)
• Inventors: Sepetka, Ivan, Pierce, Ryan, Gia, Son, Aboytes, Maria, Dieck, Martin S.
• Application Number:
  US10/106,870
• Publication Number:
  US 20020169473A1
• Time in Patent Office: Days
• US Class Current: 606/200
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12145 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 17/12177 comprising additional materials, e.g. thrombogenic, having filaments, having fibers or being coated
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 17/1219 expandable in contact with liquids
• CPC Class Codes: A61B 18/1492 having a flexible, catheter-like structure, e.g. for heart ablation A61B18/1477 takes precedence
• CPC Class Codes: A61B 2017/00004 (bio)absorbable, (bio)resorbable or resorptive
• CPC Class Codes: A61B 2017/00867 shape memory effect
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/12063 electrolytically detachable
• CPC Class Codes: A61B 2017/12068 detachable by heat
• CPC Class Codes: A61B 2017/12081 detachable by inflation
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61B 2018/00214 Expandable means emitting energy, e.g. by elements carried thereon
• CPC Class Codes: A61B 2018/00416 Treatment of aneurisms
• CPC Class Codes: A61B 2018/1495 : Electrodes being detachable from a support structure
• CPC Class Codes: A61L 2300/418 : Agents promoting blood coagulation, blood-clotting agents, embolising agents
• CPC Class Codes: A61L 24/0015 : Medicaments; Biocides
• CPC Class Codes: A61L 24/0031 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 24/04 : containing macromolecular materials
• CPC Class Codes: A61L 24/104 : Gelatin
• CPC Class Codes: A61L 2430/36 : for embolization or occlusion, e.g. vaso-occlusive compositions or devices
• CPC Class Codes: A61L 31/04 : Macromolecular materials
• CPC Class Codes: A61L 31/10 : Macromolecular materials
• CPC Class Codes: A61L 31/145 : Hydrogels or hydrocolloids
• CPC Class Codes: A61L 31/16 : Biologically active materials, e.g. therapeutic substances A61L31/047 takes precedence
• CPC Class Codes: A61M 2025/1084 : having features for increasing the shape stability, the reproducibility or for limiting expansion, e.g. containments, wrapped around fibres, yarns or strands
• CPC Class Codes: A61M 2205/36 : related to heating or cooling
• CPC Class Codes: A61M 25/0068 : Static characteristics of the catheter tip, e.g. shape, atraumatic tip, curved tip or tip structure
• CPC Class Codes: A61M 25/007 : Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 : Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/1002 : characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• 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: A61M 29/02 : Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A device for treating vascular malformations includes a primary coil and secondary windings. The primary coil provides resilience and structural integrity while the secondary windings fill interstitial spaces in the primary coil to isolate the vascular malformation. The device may have increased density along a central portion to isolate the malformation. In another aspect, the device may have a central opening through which embolic materials may be delivered.

Claims

1. A method of treating a vascular malformation, comprising the steps of:

providing a first vascular element and a second vascular element;

positioning the first vascular element at a vascular malformation;

delivering an embolic material through the first vascular element and into the vascular malformation;

moving the second vascular element to the vascular malformation after the delivering step.

2. The method of claim 1, wherein:

the providing step is carried out with the first and second vascular elements being tubular shaped.

3. The method of claim 1, wherein:

the providing step is carried out with at least one of the first and second vascular elements being a helical coil.

4. The method of claim 1, wherein:

the providing step is carried out with both the first and second vascular elements being helical coils.

5. The method of claim 1, wherein:

the delivering step is carried out with the embolic material being delivered through a catheter extending through the first vascular element.

6. The method of claim 1, wherein:

the delivering step is carried out with the embolic material being a hydrogel.

7. The method of claim 1, wherein:

the moving step is carried out by rotating the second vascular element.

8. The method of claim 1, wherein:

the moving step is carried out with the second vascular element being positioned in interstitial spaces of the first vascular element.

9. The method of claim 1, wherein:

the moving and positioning steps are carried out with the first and second vascular elements engaging one another.

10. The method of claim 1, wherein:

the positioning step is carried out with the vascular malformation being a cerebral aneurysm.

11. A device for treating a vascular malformation, comprising:

a delivery catheter;

a first vascular element coupled to the delivery catheter;

a second vascular element coupled to the delivery catheter, the second vascular element being movable into engagement with the first vascular element after at least partially deploying the first vascular element; and

an embolic material lumen configured to extend through the first vascular element.

12. The device of claim 11, wherein:

the first and second vascular elements are tubular shaped.

13. The device of claim 11, wherein:

the first vascular element is a helical coil.

14. The device of claim 11, wherein:

the first and second vascular elements are helical coils.

15. The device of claim 11, wherein:

the embolic material lumen extends through the first vascular element when delivering the embolic material.

16. The device of claim 11, wherein:

the embolic material is a hydrogel.

17. The device of claim 11, wherein:

the second vascular element rotatably engages the first vascular element.

18. The device of claim 11, wherein:

the second vascular element is shaped to be positioned in interstitial spaces of the first vascular element.

19. The device of claim 11, wherein:

the first and second vascular elements engage one another within the delivery catheter.

20. A method of treating a vascular malformation, comprising the steps of:

providing a vascular element;

positioning the first vascular element at a vascular malformation;

delivering an embolic material through the first vascular element and into the vascular malformation; and

removing the vascular element after a period of time so that the embolic material fills the vascular malformation.

21. The method of claim 20, wherein:

the positioning step is carried out with the vascular malformation being a cerebral aneurysm.

22. The method of claim 20, wherein:

the providing step is carried out with the first vascular element being tubular shaped.

23. The method of claim 20, wherein:

the providing step is carried out with the first vascular element being a helical coil.

24. The method of claim 20, wherein:

the delivering step is carried out with the embolic material being delivered through a catheter extending through the first vascular element.

25. The method of claim 20, wherein:

the delivering step is carried out with the embolic material being a hydrogel.

27. The system of claim 26, wherein:

the first vascular element has a single helical coil.

28. The system of claim 26, further comprising:

means for removing the first vascular element.

29. The system of claim 28, wherein:

the removing means is an element extending through the delivery catheter.

30. The system of claim 28, wherein:

the removing means is the delivery catheter.

26. A system for treating a vascular malformation, comprising:

a delivery catheter;

a first vascular element having a first coil coupled to the delivery catheter;

an embolic material delivery lumen configured to deliver an embolic material through the first vascular element after the first vascular element has been positioned at a vascular malformation.

31. A method of treating a vascular malformation, comprising the steps of:

providing a vascular element having a main coil and a plurality of secondary windings, the main coil being naturally biased toward an expanded position and carrying the secondary windings;

delivering the vascular element to a vascular malformation;

releasing the vascular element so that the main coil expands, the main coil also expanding the secondary windings, the vascular element forming a lumen to permit blood to pass therethrough, the vascular element isolating the vascular malformation.

32. The method of claim 31, wherein:

the providing step is carried out with at least two main coils, the at least two main coils being interwoven.

33. The method of claim 31, wherein:

the providing step is carried out with two main coils, the main coils being interwoven and each having a generally helical shape.

34. The method of claim 31, wherein:

the providing step is carried out with the device having a side opening, the side opening being larger than other openings in the vascular element.

35. The method of claim 34, further comprising the step of:

delivering an embolic material through the side opening after the releasing step.

36. The method of claim 34, wherein:

the providing step is carried out with the side opening extending circumferentially around the vascular element.

37. The method of claim 34, wherein:

the providing step is carried out with the side opening being formed by an absence of the secondary windings.

38. The method of claim 34, wherein:

the providing step is carried out with the side opening being formed by a continuous length of the secondary winding with a spacing between the secondary winding being enlarged at the side opening.

39. The method of claim 34, wherein:

the providing step is carried out with the side opening being formed by a larger spacing between adjacent windings of the secondary windings.

40. The method of claims 31 and 34, wherein:

the providing step is carried out with about 3-30 secondary windings.

41. The method of claims 31 and 34, wherein:

the providing step is carried out with about 10-50 secondary windings.

42. A device for treating a vascular malformation, comprising:

a main coil; and

a plurality of secondary windings, the main coil being naturally biased toward an expanded position, the secondary windings being substantially expanded and collapsed by the main coil.

43. The device of claim 42, further comprising:

at least two main coils, the at least two main coils being interwoven.

44. The device of claim 42, wherein:

the two main coils each having a generally helical shape.

45. The device of claim 42, wherein:

the main coil and secondary windings form a side opening, the side opening being larger than other openings in the vascular element.

46. The device of claim 45, further comprising:

an embolic material lumen configured to extend through the side opening.

47. The device of claim 45, wherein:

the side opening extending circumferentially around the vascular element.

48. The device of claim 45, wherein:

the side opening is formed by an absence of the secondary windings.

49. The device of claim 45, wherein:

the side opening is formed by an enlarged spacing between the secondary winding at the side opening.

50. The device of claim 45, wherein:

the side opening is formed by a larger spacing between adjacent windings of the secondary windings.

51. The device of claims 42 and 45, wherein:

the secondary windings number about 3-30.

52. The device of claim 42 and 45, wherein:

the secondary windings number about 10-50.

53. The device of claim 42, wherein:

the secondary windings have an increased density along a central portion.

54. A method of treating a cerebral aneurysm, comprising the steps of:

providing an expandable structure movable from a collapsed shape to an expanded shape;

introducing the expandable structure into a blood vessel of a patient;

advancing the expandable structure through the patient'"'"'s vasculature to a cerebral aneurysm while the expandable structure is in the collapsed position;

moving the expandable structure into the cerebral aneurysm;

expanding the expandable structure to the expanded position in the cerebral aneurysm;

shrinking the wall of the aneurysm; and

leaving the expandable structure in the aneurysm after the shrinking step.

55. A method of isolating a cerebral aneurysm from the parental vessel, comprising the steps of:

providing a device movable from a collapsed position to an expanded position, the device having a proximal portion when in the expanded position;

introducing the device into the aneurysm in the collapsed position;

expanding the device to the expanded position after the introducing step;

shrinking the dome of the aneurysm so that that the proximal portion of the expandable device extends around the neck of the aneurysm.

56. A system for treating a cerebral aneurysm, comprising:

a shaft having a length and flexibility sufficient to extend into a patient'"'"'s cerebral vasculature;

an expandable device movable from a collapsed shape to an expanded shape, the expandable device being removably coupled to the shaft;

means for shrinking the aneurysmal wall toward the expandable device when the expandable device is contained within the aneurysm.

57. A method of treating a cerebral aneurysm, comprising the steps of:

providing an expandable structure movable from a collapsed shape to an expanded shape, the expandable structure having a deforming portion which is displaced beyond the yield strength when moving from the collapsed position to the expanded position;

introducing the expandable structure into a blood vessel of a patient;

advancing the expandable structure through the patient'"'"'s vasculature to a cerebral aneurysm while the expandable structure is in the collapsed position;

moving the expandable structure into the cerebral aneurysm;

expanding the expandable structure to the expanded position in the cerebral aneurysm; and

leaving the expandable structure in the aneurysm after the expanding step.

58. A method of treating an aneurysm, comprising the steps of:

providing a device having a cover and a lateral extension, the cover and extension being movable from a collapsed position to an expanded position;

advancing the device through a patient'"'"'s vascular system to an aneurysm with the cover in the collapsed position;

moving the lateral extension into the neck of the aneurysm and the cover over the neck of the aneurysm to isolate the aneurysm from the parental vessel.

59. A device for treating an aneurysm, comprising:

a cover which covers the neck of the aneurysm to isolate the aneurysm from a parental vessel; and

a lateral extension coupled to the cover, the lateral extension extending from the cover and into the aneurysm when the cover is positioned over the neck of the aneurysm.

60. A method of treating an aneurysm, comprising the steps of:

providing a cover which is positioned around an expandable element in a collapsed position, the cover being covered by a sheath;

advancing the cover to an aneurysm in a patient with the cover in the collapsed position;

withdrawing the sheath to expose the cover;

expanding the expandable member thereby expanding the cover, the cover expanding to an expanded condition, the cover being positioned over a neck of the aneurysm.

61. A device for treating an aneurysm, comprising:

a cover for covering a neck of an aneurysm

a delivery catheter having an expandable element and a sheath, the cover being mounted around the expandable element, the sheath being retractable and overlying the cover thereby trapping the cover between the sheath and expandable element, the sheath being movable to a position in which the cover is exposed to permit expansion of the expandable element and the cover.