OCCLUSION CATHETER HAVING COMPLIANT BALLOON FOR USE WITH COMPLEX VASCULATURE

• US 20130281836A1
• Filed: 06/11/2013
• Published: 10/24/2013
• Est. Priority Date: 09/04/2001
• Status: Active Grant

• Current Assignee: Covidien LP (Medtronic Plc)
• Original Assignee: Covidien LP (Medtronic Plc)
• Inventors: Hayman, Douglas Ray, Davis, Peter Gregory, De Jesus Sanson, Maria, Reedy, Komonn Lim, Hewitt, Todd Jeffrey
• Granted Patent: US 8,974,409 B2
• Time in Patent Office: Days
• US Class Current: 600/424
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• 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 17/1204 temporary occlusion
• CPC Class Codes: A61B 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12186 liquid materials adapted to be injected
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 6/12 Arrangements for detecting or locating foreign bodies
• CPC Class Codes: A61M 2025/0004 having two or more concentrically arranged tubes for forming a concentric catheter system
• 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 25/0108 using radio-opaque or ultrasound markers
• CPC Class Codes: A61M 25/09 Guide wires
• 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 25/1002 characterised by balloon shape A61M25/1006, A61M25/1009 take precedence
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter used for treatment of complex vasculature, such as a bifurcated aneurysm, is provided with an inflatable balloon at a distal portion thereof. The shape, location and material of the inflatable balloon are selected such that when inflated, the balloon conforms to the shape of the complex vasculature, or at least a portion thereof, without appreciably deforming the vessel walls. In this manner, the balloon can be used to control flow in the vasculature, for example occluding a selected branch of the vasculature during introduction of material in order concentrate the material and minimize its disbursement by blood flow.

Claims

1-58. -58. (canceled)

59. A microcatheter suitable for temporary vascular occlusion comprising:

a substantially tubular structure with at least one lumen and an inflatable balloon, the inflatable balloon located at the distal portion of said tubular structure and positioned in fluid communication with said at least one lumen, said inflatable balloon being inflatable to an inflated state in which said inflatable balloon deforms at a pressure less than the pressure required to deform the vascular wall when placed into a blood vessel, said inflatable balloon dimensioned to occlude vasculature in said inflated state; and

one or more radiopaque marker bands disposed in the vicinity of the inflatable balloon.

60. The microcatheter of claim 59, wherein the at least one lumen is adapted to accommodate a guidewire.

61. The microcatheter of claim 59, wherein the balloon is formed of a material that has a modulus at about 300% having a value less than about 300 psi and/or a tensile strength of about 600 psi.

62. The microcatheter of claim 59, wherein the balloon is formed of a material that has a Hardness-Shore A ASTM D2240 (3 sec.) rating of about 15, a specific gravity of about 0.89, tensile strength of about 600 psi, and elongation of greater than about 1,000%.

63. The microcatheter of claim 59, wherein the balloon is formed of a material that has a Hardness-Shore A ASTM D2240 (3 sec.) rating of about 40, a specific gravity of about 0.90, tensile strength of about 700 psi, and elongation of about 500%.

64. The microcatheter of claim 59, wherein the balloon is formed of a material that is pre-stretched, preoriented or otherwise mechanically and/or thermally manipulated such that the balloon assumes an irregular shape when inflated.

65. The microcatheter of claim 59, wherein the thickness of the balloon is about 0.004 inches to about 0.006 inches.

66. The microcatheter of claim 59, wherein the thickness of the balloon is about 0.005 inches.

67. The microcatheter of claim 59, wherein the length of the balloon is about 4 mm to about 30 mm.

68. The microcatheter of claim 59, wherein the length of the balloon is about 7 mm to about 20 mm.

69. The microcatheter of claim 59, wherein the diameter of the balloon is about 1.5 mm to about 10 mm.

70. The microcatheter of claim 59, wherein the diameter of the balloon is about 3 mm to about 7 mm.

71. The microcatheter of claim 59, wherein the length-to-diameter ratio of the balloon is about 0.5:

1 to about 5;

1.

72. The microcatheter of claim 59, wherein the balloon is inflatable at a pressure which is slightly greater than systolic pressure.

73. The microcatheter of claim 59, wherein the balloon is inflatable at a pressure of about 200 mmHg.

74. The microcatheter of claim 59, wherein the balloon is inflatable at a pressure of about 600 mmHg.

75. The microcatheter of claim 59, wherein the substantially tubular structure includes multiple lumens.

76. The microcatheter of claim 75, wherein the substantially tubular structure includes concentric lumens.

77. A catheter suitable for use in a complex vessel comprising:

a substantially tubular structure having at least one lumen;

a single compliant inflatable balloon located at a distal portion of said tubular structure and in fluid communication with said lumen; and

one or more radiopaque marker bands disposed in the vicinity of the inflatable balloon;

wherein at least a portion of said inflatable balloon comprises a material which is is pre-stretched or mechanically or thermally manipulated during fabrication to take on the irregular shapes matching those of a vessel to which it is to be introduced;

wherein when the balloon is inflated, the balloon conforms to the shape of the vessel for a sufficient length of the vessel to attenuate and/or occlude blood flow therein; and

wherein the balloon does not significantly deform the vessel when fully inflated.

78. The catheter of claim 77, wherein the material of the inflatable balloon comprises styrenic olefinic rubber and hydrogenated isoprene.