Perfusion-isolation catheter apparatus and method

• US 6,183,492 B1
• Filed: 08/27/1998
• Issued: 02/06/2001
• Est. Priority Date: 08/28/1997
• Status: Expired due to Term

• Current Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Original Assignee: Applied Medical Resources Corporation (Applied Medical Corporation)
• Inventors: Brustad, John R., Ashby, Mark, Hansen, Paul D., Swanstrom, Lee L., Hilal, Said, Pravongviengkham, Bounsavanh, Hart, Charles C.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): LEWIS, WILLIAM W
• Application Number:
  US09/141,196
• Time in Patent Office: 894 Days
• Field of Search: 606/1, 606/108, 606/191, 606/192, 606/194, 606/195, 606/198, 604/96-101, 623/1.1, 623/1.11
• US Class Current: 606/194
• 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 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12118 for positioning in conjunction with a stent
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61M 2025/1052 for temporarily occluding a vessel for isolating a sector
• CPC Class Codes: A61M 2025/1095 with perfusion means for enabling blood circulation while the balloon is in an inflated state or in a deflated state, e.g. permanent by-pass within catheter shaft
• CPC Class Codes: A61M 2025/1097 with perfusion means for enabling blood circulation only while the balloon is in an inflated state, e.g. temporary by-pass within balloon
• CPC Class Codes: A61M 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• CPC Class Codes: A61M 25/0052 Localized reinforcement, e.g. where only a specific part of the catheter is reinforced, for rapid exchange guidewire port
• CPC Class Codes: A61M 25/1006 Balloons formed between concentric tubes
• CPC Class Codes: A61M 25/104 used for angioplasty

Abstract

A catheter includes an introducer and a flow isolator adapted for disposition in a primary conduit to facilitate flow in the primary conduit while inhibiting flow and intersecting secondary conduits. The flow isolator may include a tubular mesh and surrounding balloon structure. Alternatively, a sleeve can be provided with a primary opening and a secondary opening which are sized to inflate the sleeve with the body fluid. Structures for deploying the sleeve between a low-profile state and high-profile state may include expandable fingers, or pneumatic chambers inflatable from an external source. In operation the sleeve can be forced by the body fluid against the intersection with the secondary conduits to achieve isolation. Alternatively, the pneumatic chambers can be inflated to form seals with the primary conduit. A blood filter or snare is contemplated to filter any blood clots which may develop around the flow isolator.

Claims

1. A flow isolator adapted for use in controlling a flow of body fluid to a primary body conduit and to a secondary body conduit forming an intersection with the primary body conduit, the isolator including:

a sleeve having a flexible wall with a proximal end and a distal end, the sleeve being adapted for operational disposition within the primary conduit and across the intersection with the secondary body conduit, with the distal end of the sleeve being adapted to face in the direction of flow of the body fluid in the primary body conduit;

first portions of the sleeve at the proximal end of the sleeve being adapted to expand radially outwardly to form a seal with the primary body conduit proximally of the intersection with the secondary body conduit, to facilitate flow inwardly of the sleeve while inhibiting flow outwardly of the sleeve;

intermediate portions of the sleeve between the proximal end and the distal end directing the flow of body fluid through the sleeve and past the intersection with the second body conduit; and

second portions of the sleeve at the distal end of the sleeve directing the flow of body fluid from the sleeve into the primary body conduit distally of the intersection with the secondary body conduit.

2. The flow isolator recited in claim 1 wherein the second portions of the sleeve at the distal end of the sleeve are adapted to expand radially outwardly to form a second seal with the primary body conduit distally of the intersection with the secondary body conduit.

3. The flow isolator recited in claim 2 wherein the first portions of the sleeve form an inflatable circumferential chamber.

4. The flow isolator recited in claim 3 wherein the intermediate portions of the sleeve comprise at least one inflatable longitudinal chamber.

5. The flow isolator recited in claim 4 wherein the second portions of the sleeve form an inflatable circumferential chamber.

6. A flow isolator adapted for use in controlling a flow of a body fluid to a primary body conduit and to a secondary body conduit forming an intersection with the primary body conduit, the isolator including:

a sleeve having a flexible wall with a proximal end and a distal end, the sleeve being adapted for operational disposition within the primary conduit and across the intersection with the secondary body conduit, and with the distal end of the sleeve being adapted to face in the direction of flow of the body fluid in the primary body conduit;

first portions of the sleeve at the proximal end of the sleeve forming a first opening in the wall to facilitate flow of the body fluid into the sleeve;

second portions of the sleeve at the distal end of the sleeve forming a second opening in the wall to facilitate flow of the body fluid from the sleeve;

the second opening at the distal end of the sleeve being smaller than the first opening at the proximal end of the sleeve to increase the pressure of the body fluid within the sleeve;

the flexible wall of the sleeve being responsive to the increased pressure of the body fluid within the sleeve to move the wall against the primary conduit and thereby facilitate the flow of body fluid through the sleeve;

the sleeve in proximity to the primary conduit tending to block the intersection with the secondary body conduit to inhibit flow of the body fluid between the primary conduit and the secondary conduit;

an expansion structure disposed at the proximal end of the sleeve and being moveable from a low-profile state to a high-profile state;

the expansion structure having properties for moving the first portions of the sleeve to compress the first opening in the low-profile state in order to facilitate introduction of the sleeve, and to expand the first opening in the high-profile state in order to facilitate the flow of body fluid into the sleeve;

a plurality of fingers each contacting the sleeve at the first portions of the sleeve, the fingers being spaced from each other to facilitate flow of the body fluid through the first opening and into the sleeve; and

the fingers being moveable between the low-profile state and the high-profile state.

7. A flow isolator adapted for use in controlling a flow of a body fluid to a primary body conduit and to a secondary body conduit forming an intersection with the primary body conduit, the isolator including:

a sleeve having a flexible lateral wall with a proximal end and a distal end, the sleeve being adapted for operational disposition within the primary conduit and across the intersection with the secondary body conduit, and with the distal end of the sleeve being adapted to face in the direction of flow of the body fluid in the primary body conduit;

first portions of the sleeve at the proximal end of the sleeve forming a first opening in the wall to facilitate flow of the body fluid into the sleeve;

second portions of the sleeve at the distal end of the sleeve forming a second opening in the wall to facilitate flow of the body fluid from the sleeve;

the second opening at the distal end of the sleeve being smaller than the first opening at the proximal end of the sleeve to increase the pressure of the body fluid within the sleeve;

the flexible wall of the sleeve being responsive to the increased pressure of the body fluid within the sleeve to move the wall against the primary conduit and thereby facilitate the flow of body fluid through the sleeve;

the sleeve in proximity to the primary conduit tending to block the intersection with the secondary body conduit to inhibit flow of the body fluid between the primary conduit and the secondary conduit;

an end wall disposed at the distal end of the sleeve and extending generally radially inwardly of the lateral wall to define the second opening at the distal end of the sleeve as a plurality of holes in the end wall of the sleeve.

8. The flow isolator recited in claim 7 wherein at least one of the plurality of holes has a configuration of an ellipse.

9. A flow isolator adapted for use in controlling a flow of a body fluid to a primary body conduit and to a secondary body conduit forming an intersection with the primary body conduit, the isolator including:

a sleeve having a flexible wall with a proximal end and a distal end, the sleeve being adapted for operational disposition within the primary conduit and across the intersection with the secondary body conduit, and with the distal end of the sleeve being adapted to face in the direction of flow of the body fluid in the primary body conduit;

first portions of the sleeve at the proximal end of the sleeve forming a first opening in the wall to facilitate flow of the body fluid into the sleeve;

second portions of the sleeve at the distal end of the sleeve forming a second opening in the wall to facilitate flow of the body fluid from the sleeve;

the second opening at the distal end of the sleeve being smaller than the first opening at the proximal end of the sleeve to increase the pressure of the body fluid within the sleeve;

the flexible wall of the sleeve being responsive to the increased pressure of the body fluid within the sleeve to move the wall against the primary conduit and thereby facilitate the flow of body fluid through the sleeve;

the sleeve in proximity to the primary conduit tending to block the intersection with the secondary body conduit to inhibit flow of the body fluid between the primary conduit and the secondary conduit; and

the wall of the sleeve comprising a plurality of inflatable chambers disposed longitudinally of the sleeve.

10. A flow isolator adapted for use in controlling a flow of a body fluid to a primary body conduit and to a secondary body conduit forming an intersection with the primary body conduit, the isolator including:

a sleeve having a flexible wall with a proximal end and a distal end, the sleeve being adapted for operational disposition within the primary conduit and across the intersection with the secondary body conduit, and with the distal end of the sleeve being adapted to face in the direction of flow of the body fluid in the primary body conduit;

first portions of the sleeve at the proximal end of the sleeve forming a first opening in the wall to facilitate flow of the body fluid into the sleeve;

second portions of the sleeve at the distal end of the sleeve forming a second opening in the wall to facilitate flow of the body fluid from the sleeve;

the second opening at the distal end of the sleeve being smaller than the first opening at the proximal end of the sleeve to increase the pressure of the body fluid within the sleeve;

the flexible wall of the sleeve being responsive to the increased pressure of the body fluid within the sleeve to move the wall against the primary conduit and thereby facilitate the flow of body fluid through the sleeve;

the sleeve in proximity to the primary conduit tending to block the intersection with the secondary body conduit to inhibit flow of the body fluid between the primary conduit and the secondary conduit; and

third portions of the wall defining a third opening at the intersection of the primary conduit and the secondary conduit, the third portions being moveable between a first position wherein the third opening facilitates communication of the body fluid between the primary conduit and the secondary conduit, and a second position wherein the third opening inhibits communication of the body fluid between the primary conduit and the secondary conduit.

11. A catheter adapted for introduction into a primary conduit and relative to a secondary conduit forming an intersection with the primary conduit, the catheter comprising:

a flow isolator having a high-profile state and a low-profile state, an obturator coupled to the flow isolator for introducing the flow isolator to an operative site in the primary conduit;

a braided tubular structure included in the flow isolator, the tubular structure being naturally expandable to the high-profile state and being longitudinally expandable to the low-profile state;

a balloon included in the flow isolator and disposed in juxtaposition to the tubular structure outside the tubular structure, the balloon being deflatable to the low-profile state and inflatable to the high-profile state; and

the flow isolator in the low-profile state being adapted for introduction into the primary conduit, and in the high-profile state, being adapted to facilitate flow through the primary conduit while blocking the intersection to inhibit flow in the secondary conduit.

12. The catheter recited in claim 11 wherein the balloon of the flow isolator is disposed circumferentially of the braided tubular structure.

13. The catheter recited in claim 12 wherein the braided tubular structure coaxial with the balloon.

14. The catheter recited in claim 11 wherein the tubular structure is formed from a multiplicity of filaments interwoven to define a central channel through the tubular structure and a multiplicity of interstices providing fluid communication between the central lumen and regions disposed laterally of the tubular structure.

15. A method for controlling flow of a body fluid in a primary conduit and a secondary conduit forming an intersection with the primary conduit, comprising the steps of:

positioning across the intersection a flow isolator having a proximal end and a distal end, the distal end facing in the direction of normal flow of the body fluid within the primary conduit; and

pressurizing the sleeve to force the sleeve against the primary conduit thereby facilitating flow of the body fluid in the primary conduit while inhibiting flow of the body fluid through the intersection between the primary conduit and the secondary conduit.

16. The method recited in claim 15 wherein the normal flow of body fluid in the primary conduit is in a particular direction, and the method further comprises the steps of:

during the positioning step placing the distal end of the flow isolator in the particular direction relative to the intersection of the primary conduit and the secondary conduit.

17. The method recited in claim 16 wherein the pressuring step includes the steps of:

providing the proximal end of the flow isolator with a first opening;

providing the distal end of the flow isolator with the second opening; and

the second opening being smaller than the first opening to increase the pressure of the body fluid within the flow isolator.

18. The method recited in claim 15 further comprising the steps of:

providing the flow isolator with a plurality of chambers; and

inflating the chambers during the positioning step to force the flow isolator against the primary conduit.

19. The method recited in claim 18 wherein the providing step includes the step of forming one of the chambers with a longitudinal configuration.

20. The method recited in claim 18 wherein the providing step includes the step of forming one of the chambers with a circumferential configuration.

21. The method recited in claim 18 wherein the inflating step includes the step of inflating the chambers with a gas.

22. The method recited in claim 18 wherein the providing step includes the step of:

forming the sleeve with at least one of the chambers disposed at the proximal end of the sleeve.