Vascular dilator for controlling blood flow in a blood vessel

• US 9,248,262 B2
• Filed: 08/31/2010
• Issued: 02/02/2016
• Est. Priority Date: 08/31/2010
• Status: Active Grant

• Current Assignee: Vibha Agarwal
• Original Assignee: Vibha Agarwal
• Inventors: Mukherjee, Dipankar
• Primary Examiner(s): WEISBERG, AMY REGINA
• Application Number:
  US12/923,043
• Publication Number:
  US 20120053614A1
• Time in Patent Office: 1,981 Days
• Field of Search: 606/194, 606/159, 606/200, 606190-192, 60410101-10105
• US Class Current: 1/1
• CPC Class Codes: A61B 17/1204 temporary occlusion
• 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 17/12113 within an aneurysm
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 2017/12004 for haemostasis, for prevention of bleeding
• CPC Class Codes: A61B 2017/1205 Introduction devices
• CPC Class Codes: A61B 2017/22038 with a guide wire
• CPC Class Codes: A61B 2090/062 penetration depth
• CPC Class Codes: A61B 2090/0811 for the position of a particular part of an instrument with respect to the rest of the instrument, e.g. position of the anvil of a stapling instrument
• CPC Class Codes: A61B 2090/3762 using computed tomography systems [CT]
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• 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 2205/582 by tactile feedback
• CPC Class Codes: A61M 2205/583 by visual feedback
• 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 25/0662 Guide tubes
• CPC Class Codes: A61M 25/1011 Multiple balloon catheters
• CPC Class Codes: A61M 29/02 Dilators made of swellable material balloon catheters for angioplasty A61M25/104

Abstract

A vascular dilator for controlling blood flow in a blood vessel, includes an elongate body for inserting into a blood vessel and a generally tapered distal end portion and a proximal end portion, and a plurality of inflatable members positioned adjacent the distal end portion. The inflatable members are longitudinally spaced from one another by a predetermined distance.

Claims

1. A method of repairing an aneurysm in an arterial blood vessel of a subject, comprising the steps of:

a) providing a dilator-introducer sheath complex, consisting of;

i) a dilator, consisting of;

an elongate generally rigid body having a length, a proximal end portion and distal end portion;

a tapered distal end portion;

a plurality of inflatable members positioned adjacent the distal end portion on the elongate generally rigid body;

the plurality of inflatable members being longitudinally spaced from one another by a distance of 2 cm to less than 5 cm and being proximal to the tapered distal end portion; and

the elongate generally rigid body having a solid tubular structure with a generally uniform diameter throughout the length thereof, and including a plurality of peripherally oriented lumens in fluid communication with the respective plurality of inflatable members and a central channel for extending a guidewire therethrough;

ii) an introducer sheath including an open distal end portion and a proximal end portion;

iii) wherein the dilator is slidably positioned inside of the introducer sheath such that a selected one of the plurality of inflatable members is positioned adjacent the open distal end portion of the introducer sheath;

b) advancing the dilator-introducer sheath complex through an aneurysm in a blood vessel selected from the group consisting of a thoracic aorta, an abdominal aorta, and an iliac artery, until the open distal end portion of the introducer sheath passes the aneurysm in the associated blood vessel;

c) withdrawing, after step b), the introducer sheath such that the selected one inflatable member passes through and is positioned on the open distal end portion of the introducer sheath;

d) inflating, after step c), the selected one inflatable member to stop an antegrade flow of blood through the associated blood vessel; and

e) repairing the aneurysm.

2. The method of claim 1, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an aneurysm in a thoracic aorta.

3. The method of claim 1, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an aneurysm in an abdominal aorta.

4. The method of claim 1, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an aneurysm in an iliac artery.

5. The method of claim 1, wherein:

the aneurysm includes a perforation, tear, or rupture.

6. A method of repairing an aneurysm in an arterial blood vessel of a subject, comprising the steps of:

a) providing a dilator-introducer sheath complex, consisting of;

i) a dilator, consisting of;

an elongate generally rigid body having a length, a proximal end portion and distal end portion;

a tapered distal end portion;

a plurality of inflatable members positioned adjacent the distal end portion on the elongate generally rigid body;

the plurality of inflatable members being longitudinally spaced from one another by a distance of 2 cm to less than 5 cm and being proximal to the tapered distal end portion; and

the elongate generally rigid body having a solid tubular structure with a generally uniform diameter throughout the length thereof, and including a plurality of peripherally oriented lumens in fluid communication with the respective plurality of inflatable members and a central channel for extending a guidewire therethrough;

ii) an introducer sheath including an open distal end portion and a proximal end portion;

iii) wherein the dilator is slidably positioned inside of the introducer sheath such that a selected one of the plurality of inflatable members is positioned adjacent the open distal end portion of the introducer sheath;

b) advancing the dilator-introducer sheath complex through an aneurysm in a blood vessel selected from the group consisting of a thoracic aorta, an abdominal aorta, and an iliac artery, until the open distal end portion of the introducer sheath passes the aneurysm in the associated blood vessel;

c) withdrawing, after step b), the introducer sheath such that the selected one inflatable member passes through the open distal end portion of the introducer sheath;

d) inflating, after step c), the selected one inflatable member to stop an antegrade flow of blood through the associated blood vessel;

e) further withdrawing, after step d), the introducer sheath such that a selected second of the inflatable members passes through the open distal end portion of the introducer sheath;

f) inflating, after step e), the selected second inflatable member to stop a retrograde flow of blood through the associated blood vessel; and

g) repairing the aneurysm.

7. The method of claim 6, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an aneurysm in a thoracic aorta.

8. The method of claim 6, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an aneurysm in an abdominal aorta.

9. The method of claim 6, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an aneurysm in an iliac artery.

10. The method of claim 6, wherein:

the aneurysm includes a perforation, tear, or rupture.

11. A method of controlling bleeding from an arterial blood vessel of a subject, comprising the steps of:

a) providing a dilator-introducer sheath complex, consisting of;

i) a dilator, consisting of;

an elongate generally rigid body having a length, a proximal end portion and distal end portion;

a tapered distal end portion;

a plurality of inflatable members positioned adjacent the distal end portion on the elongate generally rigid body;

the plurality of inflatable members being longitudinally spaced from one another by a distance of 2 cm to less than 5 cm and being proximal to the tapered distal end portion; and

the elongate generally rigid body having a solid tubular structure with a generally uniform diameter throughout the length thereof, and including a plurality of peripherally oriented lumens in fluid communication with the respective plurality of inflatable members and a central channel for extending a guidewire therethrough;

ii) an introducer sheath including an open distal end portion and a proximal end portion;

iii) wherein the dilator is slidably positioned inside of the introducer sheath such that a selected one of the plurality of inflatable members is positioned adjacent the open distal end portion of the introducer sheath;

b) advancing the dilator-introducer sheath complex through a bleeding blood vessel selected from the group consisting of a thoracic aorta, an abdominal aorta, and an iliac artery, until the open distal end portion of the introducer sheath passes a bleeding point in the associated blood vessel;

c) withdrawing, after step b), the introducer sheath such that the selected one inflatable member passes through and is positioned on the open distal end portion of the introducer sheath;

d) inflating, after step c), the selected one inflatable member to stop an antegrade flow of blood through the associated blood vessel;

e) repairing the bleeding blood vessel.

12. The method of claim 11, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through a thoracic aorta.

13. The method of claim 11, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an abdominal aorta.

14. The method of claim 11, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an iliac artery.

15. The method of claim 11, wherein:

the bleeding point includes a perforation, tear, or rupture.

16. A method of controlling bleeding from an arterial blood vessel of a subject, comprising the steps of:

a) providing a dilator-introducer sheath complex, consisting of;

i) a dilator, consisting of;

an elongate generally rigid body having a length, a proximal end portion and distal end portion;

a tapered distal end portion;

a plurality of inflatable members positioned adjacent the distal end portion on the elongate generally rigid body;

the plurality of inflatable members being longitudinally spaced from one another by a distance of 2 cm to less than 5 cm and being proximal to the tapered distal end portion; and

the elongate generally rigid body having a solid tubular structure with a generally uniform diameter throughout the length thereof, and including a plurality of peripherally oriented lumens in fluid communication with the respective plurality of inflatable members and a central channel for extending a guidewire therethrough;

ii) an introducer sheath including an open distal end portion and a proximal end portion;

iii) wherein the dilator is slidably positioned inside of the introducer sheath such that a selected one of the plurality of inflatable members is positioned adjacent the open distal end portion of the introducer sheath;

b) advancing the dilator-introducer sheath complex through a bleeding blood vessel selected from the group consisting of a thoracic aorta, an abdominal aorta, and an iliac artery, until the open distal end portion of the introducer sheath passes a bleeding point in the associated blood vessel;

c) withdrawing, after step b), the introducer sheath such that the selected one inflatable member passes through the open distal end portion of the introducer sheath;

d) inflating, after step c), the selected one inflatable member to stop an antegrade flow of blood through the associated blood vessel;

e) further withdrawing, after step d), the introducer sheath such that a selected second of the inflatable members passes through and is positioned on the open distal end portion of the introducer sheath;

f) inflating, after step e), the selected second inflatable member to stop a retrograde flow of blood through the associated blood vessel; and

g) repairing the bleeding blood vessel.

17. The method of claim 16, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through in a thoracic aorta.

18. The method of claim 16, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an abdominal aorta.

19. The method of claim 16, wherein:

the step b) comprises advancing the dilator-introducer sheath complex through an iliac artery.

20. The method of claim 16, wherein:

the bleeding point includes a perforation, tear, or rupture.