Catheter system for emboli containment

• US 6,022,336 A
• Filed: 03/06/1997
• Issued: 02/08/2000
• Est. Priority Date: 05/20/1996
• Status: Expired due to Term

• Current Assignee: Mirage IP LLC (IP Edge LLC)
• Original Assignee: Percusurge Inc. (Medtronic Plc)
• Inventors: Muni, Ketan P., Bagaoisan, Celso J., Zadno-Azizi, Gholam-Reza
• Primary Examiner(s): Coggins, Wynn Wood
• Assistant Examiner(s): Gring, N. Kent
• Application Number:
  US08/812,570
• Time in Patent Office: 1,069 Days
• Field of Search: 604/101, 604/48, 604/52, 604/53, 604/102, 604/103, 604/95, 604/96, 604/27, 606/159, 606/194
• US Class Current: 604/101.05
• 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 2017/22067 Blocking; Occlusion A61B2017/22054 takes precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving
• 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 2025/0037 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 2025/09008 having a balloon
• CPC Class Codes: A61M 2025/09175 having specific characteristics at the distal tip
• 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 2025/1052 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 25/0026 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 25/005 with embedded materials for reinforcement, e.g. wires, coils, braids
• 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 25/008 : Strength or flexibility characteristics of the catheter tip
• CPC Class Codes: A61M 25/09 : Guide wires
• CPC Class Codes: A61M 25/09033 : with fixed mandrils, e.g. mandrils fixed to tip; Tensionable 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 25/1011 : Multiple balloon catheters
• CPC Class Codes: A61M 25/1018 : Balloon inflating or inflation-control devices
• CPC Class Codes: A61M 25/10184 : Means for controlling or monitoring inflation or deflation
• 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 multi-catheter emboli containment system is disclosed which is adapted to provide at least one pair of optimized paths for irrigation and aspiration fluid flow. Through careful design of the cross-sectional area of these paths, the present system is able to be compactly utilized in even the smaller size blood vessels. The catheter system itself is provided with occlusive devices to form an emboli containment chamber in which irrigation and aspiration occur. The catheter system of the present invention provides an improved emboli containment and removal system which can be utilized in a wide range of vessel diameters. The system is easy to use and can quickly and efficiently evacuate the containment chamber.

Claims

1. A catheter system for a vascular network, comprising:

a hollow guidewire having a proximal end and a distal end;

an inflatable balloon mounted on the distal end of the guidewire;

an intermediate catheter, wherein at least a portion of said intermediate catheter is positioned over said guidewire such that an inner fluid pathway is formed therebetween and such that the intermediate catheter is slidable to a location proximal to the balloon; and

a main catheter sized to receive the intermediate catheter such that an outer fluid pathway is formed therebetween for either irrigation or aspiration, said main catheter having an inflatable balloon mounted on a distal end which cooperates with the balloon on the inner catheter to form a chamber therebetween, and the main catheter having a port which is in fluid communication with the chamber to permit simultaneous irrigation and aspiration within the chamber;

wherein the port is sized to allow the passage only of particles between about 20 micrometers and up to about 500 micrometers for the removal of said particles from said chamber; and

wherein irrigation is provided at one end of the chamber and aspiration is provided at the other end of the chamber creating a pressure change within the chamber that does not exceed about 50 psi.

2. The system of claim 1, wherein said intermediate catheter comprises an irrigation catheter.

3. The system of claim 1, wherein said intermediate catheter comprises an aspiration catheter.

4. The system of claim 1, wherein said intermediate catheter comprises a therapy catheter.

5. The system of claim 4, wherein said therapy catheter comprises a catheter selected from the group consisting of a balloon angioplasty catheter, a stent deploying catheter, an ultrasound device, and a drug delivery catheter.

6. The system of claim 1, wherein said intermediate catheter comprises a catheter which can both aspirate and irrigate.

7. The system of claim 1, wherein the inner pathway and the outer pathway each have an opening at a distal end which are approximately equal in size.

8. The system of claim 1, wherein the inner pathway and the outer pathway each have an opening at a distal end of at least about 150 micrometers.

9. The system of claim 1, wherein the inner pathway and outer pathway comprise each have an opening at a distal end of at least about 500 micrometers in diameter.

10. The system of claim 1, wherein said intermediate catheter further comprises a main lumen and a separate lumen adjacent said main lumen sized to received said inner catheter slidably therein.

11. The system of claim 10, wherein said separate lumen further comprises a slit in an outside wall of said separate lumen for insertion and removal of the inner catheter therethrough.

12. The system of claim 1, wherein irrigation fluid is provided through said inner pathway and aspiration pressure is provided through said outer pathway.

13. The system of claim 1, wherein the inner fluid pathway and the outer fluid pathway each have an opening at a distal end which are sized to balance fluid flow.

14. The system of claim 1, wherein the inner fluid pathway and the outer fluid pathway each have an opening at a distal end of at least about 150 micrometers.

15. A catheter system for treating a blood vessel, comprising:

a hollow guidewire having a proximal end and a distal end;

an occlusion device mounted on the distal end of the guidewire;

an intermediate catheter, wherein at least a portion of the intermediate catheter is positioned over the guidewire such that an inner fluid pathway is formed therebetween to permit irrigation or aspiration and such that the intermediate catheter is slidable along said guidewire to a location proximal to the occlusion device; and

a main catheter sized to receive the intermediate catheter such that an outer fluid pathway is formed therebetween for simultaneous irrigation or aspiration;

wherein irrigation is provided through one of the fluid pathways and aspiration is provided through the other fluid pathway creating a pressure change within the vessel that does not exceed about 50 psi.

16. The catheter system of claim 15, wherein the main catheter includes a port which permits simultaneous irrigation or aspiration.

17. The catheter system of claim 15, wherein the main catheter has an outer diameter of less than about 5 mm.

18. The catheter system of claim 15, wherein the inner fluid pathway and the outer fluid pathway each have an opening at a distal end of at least about 150 micrometers.

19. The catheter system of claim 15, wherein the inner fluid pathway and the outer fluid pathway each have an opening at a distal end of at least about 500 micrometers.

20. The catheter system of claim 15, wherein the inner catheter is constructed of nickel titanium.

21. The catheter system of claim 15, wherein the inner catheter has an outside diameter of about 0.014 inches.

22. The catheter system of claim 15, wherein the inner fluid pathway and the outer fluid pathway each have an opening at a distal end which are sized to balance fluid flow.