Method and Apparatus for Emboli Containment

• US 20070060942A2
• Filed: 02/21/2001
• Published: 03/15/2007
• Est. Priority Date: 05/20/1996
• Status: Abandoned Application

• Current Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Original Assignee: Medtronic Vascular, Inc. (Medtronic Plc)
• Inventors: Zadno-Azizi, Gholam-Reza
• Application Number:
  US09/790,220
• Publication Number:
  US 20030208222A1
• Time in Patent Office: Days
• US Class Current: 606/194
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• 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 2017/12127 Double occlusion, e.g. for creating blood-free anastomosis site
• CPC Class Codes: A61B 2017/22055 with three or more balloons
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• CPC Class Codes: A61B 2017/320716 comprising means for preventing embolism by dislodged material
• CPC Class Codes: A61B 2217/005 with suction drainage system
• CPC Class Codes: A61M 2025/0018 having a plug, e.g. an inflatable plug for closing catheter lumens
• CPC Class Codes: A61M 2025/0034 characterized by elements which are assembled, connected or fused, e.g. splittable tubes, outer sheaths creating lumina or separate cores making of catheters A61M25/0009
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/0037 characterized by lumina being arranged side-by-side
• CPC Class Codes: A61M 2025/0081 Soft tip
• CPC Class Codes: A61M 2025/0183 Rapid exchange or monorail catheters
• CPC Class Codes: A61M 2025/0681 Systems with catheter and outer tubing, e.g. sheath, sleeve or guide tube
• CPC Class Codes: A61M 2025/1015 having two or more independently movable balloons where the distance between the balloons can be adjusted, e.g. two balloon catheters concentric to each other forming an adjustable multiple balloon catheter system
• CPC Class Codes: A61M 2025/1031 Surface processing of balloon members, e.g. coating or deposition; Mounting additional parts onto the balloon member's surface
• CPC Class Codes: A61M 2025/1045 : for treating bifurcations, e.g. balloons in y-configuration, separate balloons or special features of the catheter for treating bifurcations
• CPC Class Codes: A61M 2025/1052 : for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1079 : having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2025/109 : having balloons for removing solid matters, e.g. by grasping or scraping plaque, thrombus or other matters that obstruct the flow
• CPC Class Codes: A61M 2025/1093 : having particular tip characteristics
• CPC Class Codes: A61M 25/0009 : Making of catheters or other medical or surgical tubes
• CPC Class Codes: A61M 25/0012 : with embedded structures, e.g. coils, braids, meshes, strands or radiopaque coils
• CPC Class Codes: A61M 25/0026 : Multi-lumen catheters with stationary elements catheter assemblies comprising a catheter in combination with a guide tube, sheath or sleeve A61M2025/0681; catheters comprising telescoping coaxial elements A61M2025/0175
• CPC Class Codes: A61M 25/0029 : characterized by features relating to least one lumen located at the middle part of the catheter, e.g. slots, flaps, valves, cuffs, apertures, notches, grooves or rapid exchange ports catheter shaft surface irregularities A61M2025/006
• CPC Class Codes: A61M 25/0032 : characterized by at least one unconventionally shaped lumen, e.g. polygons, ellipsoids, wedges or shapes comprising concave and convex parts
• CPC Class Codes: A61M 25/0053 : having a variable stiffness along the longitudinal axis, e.g. by varying the pitch of the coil or braid
• CPC Class Codes: A61M 25/0054 : with regions for increasing flexibility
• 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 25/0075 : Valve means
• 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 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/1018 : Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/1027 : Making of balloon catheters
• CPC Class Codes: A61M 25/104 : used for angioplasty
• CPC Class Codes: B29C 55/04 : uniaxial, e.g. oblique

Abstract

A catheter for use in an emboli containment system includes a flexible elongate member having self-expanding sealing means mounted on its distal extremeity. This self-expanding sealing means can take any suitable form, such as a braided structure formed of a suitable shape memory material such as a nickel titanium alloy. In order to prevent abrasion of a vessel, it is desirable to cover the braided structure with a covering of a suitable material such as a polymer which extends over the braided structure and which moves with the braided structure as it expands and contracts.

Claims

1. A method of protecting a patient from embolization during a percutaneous procedure on a vessel, comprising the steps of:

providing a flexible elongate member having proximal and distal ends, a proximal and a distal region, an expandable member associated with the distal region, and a removable sheath which covers the expandable member and is slidable over the flexible elongate member;

introducing the distal end of the flexible elongate member into the patient'"'"'s vessel with the sheath covering the expandable member, and positioning the expandable member downstream of a region of interest, wherein the sheath and flexible elongate member cross the region of interest;

sliding the sheath toward the proximal end of the flexible elongate member to uncover the expandable member and deploy the expandable member;

advancing over the flexible elongate member a stent-deployment catheter to the region of interest; and

expanding a stent at the region of interest,

wherein embolic material is generated and captured before the expandable member is removed from the patient'"'"'s vessel.

3. The method of claim 1, wherein the stent is deployed by inflation of a balloon.

5. The method of claim 1, wherein the expandable member comprises a braided structure.

6. The method of claim 1, wherein the expandable member includes a covering.

7. The method of claim 1, wherein the expandable member is self-expanding.

9. A percutaneous system, comprising:

a flexible elongate member having proximal and distal ends, a proximal and distal region, and an expandable member associated with the distal region;

a sheath which is shaped to receive the flexible elongate member and retain the expandable member in a contracted condition, and to slidably release the expandable member to an expanded condition when the sheath moves toward the proximal end of the flexible elongate member;

a catheter having a proximal and a distal end, a proximal and a distal region, and a lumen which slidably receives the flexible elongate member; and

an expandable stent disposed about the distal region of the catheter, the stent having a first diameter which permits intraluminal delivery of the stent into a body passageway and which places the stent in close proximity to the catheter, and having a second expanded diameter adapted to substantially engage a wall of the body passageway,

wherein, during use, the flexible elongate member is positioned across a region of interest, the expandable member is expanded, and the stent is deployed within the region of interest and remains in place after removal of the catheter from the vessel.

10. The system of claim 9 wherein the expandable member comprises a braided structure and a covering over the braided structure.

11. The system of claim 10, wherein the braided structure is self-expanding.

18. The system of claim 9, wherein the stent and the expandable member are self-expanding.

19. The system of claim 9, wherein the stent is removable.

20. The system of claim 9, wherein the stent is self-expanding.

22. The system of claim 9, wherein the stent comprises a nickel-titanium alloy material.

23. The system of claim 9, wherein the stent is cylindrically-shaped.

25. A method of protecting a patient from embolization during a percutaneous procedure on a vessel, comprising the steps of:

providing a guidewire having proximal and distal ends, a proximal and a distal region, an expandable filter associated with the distal region, and a removable sheath which covers the expandable filter and is slidable over the guidewire;

introducing the distal end of the guidewire into the patient'"'"'s vessel with the sheath covering the expandable filter, and positioning the filter downstream of a region of interest, wherein the sheath and guidewire cross the region of interest;

sliding the sheath toward the proximal end of the guidewire and removing the sheath from the vessel, wherein the expandable filter is uncovered;

deploying the filter;

advancing over the guidewire a stent-deployment catheter to the region of interest; and

expanding the stent at the region of interest, wherein embolic material is generated and captured before the expandable filter is removed from the patient'"'"'s vessel.

26. A percutaneous system having filter and stent deployment capabilities, comprising:

a guidewire having proximal and distal ends, a proximal and distal region, and an expandable filter associated with the distal region;

a sheath which is shaped to receive the guidewire and retain the filter in a contracted condition, and to slideably release the filter to an expanded condition when the sheath moves toward the proximal end of the guidewire;

a catheter having a proximal and a distal end, a proximal and a distal region, and a lumen which slideably receives the guidewire; and

an expandable stent disposed about the distal region of the catheter, the stent having a first diameter which permits intraluminal delivery of the stent into a body passageway and which places the stent in close proximity to the catheter, and having a second expanded diameter adapted to substantially engage a wall of the body passageway, wherein, during use, the guidewire is positioned across a region of interest, the filter is expanded, and the stent is deployed within the region of interest and remains in place after removal of the catheter from the vessel.

27. A method of protecting a patient from embolization during a percutaneous procedure on a vessel, comprising the steps of:

providing a flexible elongate member having proximal and distal extremities, a self-expanding member mounted on the distal extremity, and a sleeve covering and compressing the self-expanding member;

advancing the distal extremity of the flexible elongate member and the sleeve into the patient'"'"'s vessel and positioning the self-expanding member adjacent to a stenosis to be treated;

retracting the sleeve toward the proximal end of the flexible elongate member to uncover the self-expanding member and to permit the self-expanding member to expand to a vessel wall adjacent to the stenosis;

advancing a stent delivery catheter carrying a stent thereon to the stenosis; and

expanding the stent at the stenosis while the self-expanding member is expanded, wherein emboli which may be dislodged during the delivery and expanding of the stent are captured before the self-expanding member is removed from the patient'"'"'s vessel.

28. The method of claim 27, wherein the stent-delivery catheter is advanced in co-axial relationship relative to the flexible elongate member.

29. The method of claim 27, wherein the self-expanding member is braided.

30. The method of claim 27, wherein the self-expanding member is made of a shape memory material.

31. The method of claim 27, wherein the self-expanding member is made of a nickel titanium alloy.

32. A percutaneous system having stent deployment capabilities, comprising:

a flexible elongate member having proximal and distal extremities and a self-expanding member mounted on the distal extremity;

a sleeve having a proximal and distal extremity, the sleeve having a bore to receive the flexible elongate member and to cover and compress the self-expanding member, the sleeve being retractable to uncover the self-expanding member to permit the self-expanding member to expand into engagement with a vessel wall adjacent to a stenosis to be treated; and

a stent delivery catheter having a flexible shaft and a lumen; and

an expandable stent carried on the stent delivery catheter, wherein, during use, the self expanding member is positioned and expanded adjacent to a stenosis to be treated and the stent is deployed at the stenosis and remains in place after removal of the stent delivery catheter.

33. The percutaneous system of claim 32, wherein the sleeve further comprises a collar mounted on the proximal extremity of the sleeve whereby the sleeve may be retracted to uncover the self-expanding member to permit the self-expanding member to expand to the vessel adjacent the stenosis to be treated.

34. The percutaneous system of claim 32, wherein the self-expanding member is braided.

35. The percutaneous system of claim 32, wherein the self-expanding member is made of a shape memory material.

36. The percutaneous system of claim 35, wherein the self-expanding member is made of a nickel titanium alloy.

37. The percutaneous system of claim 32, wherein the stent is self-expanding.

38. A method of protecting a patient from embolization during a percutaneous procedure on a vessel, comprising the steps of:

providing a flexible elongate member having proximal and distal extremities, a braided structure mounted on the distal extremity, and an elongate sleeve which covers the braided structure;

advancing the distal extremity of the flexible elongate member into the patient'"'"'s vessel with the elongate sleeve covering the braided structure, and positioning the elongate sleeve and flexible elongate member such that the elongate sleeve and flexible elongate member cross a region of interest;

retracting the elongate sleeve toward the proximal end of the flexible elongate member, wherein the braided structure is uncovered;

advancing over the flexible elongate member a stent delivery catheter to the region of interest; and

deploying a stent at the region of interest, wherein embolic material is generated and captured before the braided structure is removed from the patient'"'"'s vessel.

39. A percutaneous system having stent deployment capabilities, comprising:

a flexible elongate member having proximal and distal extremities and a braided structure mounted on the distal extremity;

an elongate sleeve having a bore to receive the flexible elongate member and retain the braided structure in a compressed condition, and is retractable toward the proximal end of the flexible elongate member to release the braided structure to an expanded condition;

a catheter having a flexible shaft and a lumen; and

an expandable stent carried on the catheter, wherein, during use, the flexible elongate member is positioned adjacent a stenosis to be treated, the braided structure is expanded, and the stent is deployed at the stenosis and remains in place after removal of the catheter from the vessel.

40. A method of protecting a patient from embolization during a percutaneous procedure on a vessel, comprising the steps of:

providing a flexible elongate member having proximal and distal ends, a proximal and a distal region, an expandable member associated with the distal region, and a sleeve which covers the expandable member;

introducing the distal end of the flexible elongate member into the patient'"'"'s vessel with the sleeve covering the expandable member, and positioning the expandable member adjacent to a region of interest to be treated;

retracting the sleeve toward the proximal end of the flexible elongate member to uncover the expandable member and deploy the expandable member;

advancing a stent-delivery catheter to the region of interest; and

expanding a stent at the region of interest,

wherein embolic material generated during the procedure is captured before the expandable member is removed from the patient'"'"'s vessel.

41. The method of claim 40, wherein the expandable member comprises a filter.

42. The method of claim 40, wherein the expandable member comprises a braided structure.

43. The method of claim 40, wherein the expandable member is self-expanding.

44. The method of claim 40, wherein the flexible elongate member comprises a guidewire.

45. The method of claim 40, wherein the region of interest comprises a stenosis.

46. The method of claim 40, wherein the stent-delivery catheter is delivered over the flexible elongate member to the region of interest.

47. The method of claim 40, wherein the expandable member is positioned downstream of the region of interest, wherein the sleeve and the expandable member cross the region of interest.

48. A percutaneous system, comprising:

a flexible elongate member having proximal and distal ends, a proximal and distal region, and an expandable member associated with the distal region;

a sleeve having a proximal and distal extremity, wherein the sleeve is adapted to receive the flexible elongate member and to cover the expandable member, and wherein the sleeve is adapted to retract to uncover the expandable member to permit the expandable member to expand adjacent to a region of interest; and

a stent delivery catheter having a flexible shaft and a lumen; and

an expandable stent carried by the stent delivery catheter,

wherein the expandable member is positionable and expandable adjacent to the region of interest, and

wherein the stent is deployable at the region of interest and able to remain in place after removal of the stent delivery catheter.

49. The percutaneous system of claim 48, wherein the expandable member comprises a filter.

50. The percutaneous system of claim 48, wherein the expandable member comprises a braided structure.

51. The percutaneous system of claim 48, wherein the expandable member is adapted to expand into engagement with a vessel wall.

52. The percutaneous system of claim 48, wherein the expandable member is self-expanding.

53. The percutaneous system of claim 48, wherein the sleeve comprises a bore to receive the flexible elongate member.

54. The percutaneous system of claim 48, wherein the region of interest comprises a stenosis.

55. The percutaneous system of claim 48, wherein the expandable stent has a first diameter which permits intraluminal delivery of the stent into a body passageway and which permits placement of the stent in close proximity to the catheter, and wherein the stent has a second expanded diameter adapted to substantially engage a wall of the body passageway.

56. The percutaneous system of claim 48, wherein the flexible elongate member comprises a guidewire.

57. The percutaneous system of claim 48, wherein the flexible elongate member is positionable across a region of interest with the expandable member expanded and the stent deployed within the region of interest.

58. The percutaneous system of claim 48, wherein the lumen slideably receives the flexible elongate member.

59. The percutaneous system of claim 48, wherein the expandable member is a self-expanding braided filter and the flexible elongate member is a guidewire.