Multi-lumen central access vena cava filter apparatus and method of using same

• US 9,101,450 B2
• Filed: 12/20/2012
• Issued: 08/11/2015
• Est. Priority Date: 08/31/2007
• Status: Active Grant

• Current Assignee: Mermaid Medical Vascular ApS
• Original Assignee: Bio2 Medical Inc.
• Inventors: Angel, Luis F., Steinmetz, Jeffrey N.
• Primary Examiner(s): Nguyen, Victor
• Assistant Examiner(s): EVERAGE, KEVIN D
• Application Number:
  US13/722,221
• Publication Number:
  US 20130197565A1
• Time in Patent Office: 964 Days
• Field of Search: 606/200
• US Class Current: 1/1
• CPC Class Codes: A61F 2/0103 With centering means
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2/0108 Both ends closed, i.e. legs gathered at both ends
• CPC Class Codes: A61F 2/013 Distal protection devices, i.e. devices placed distally in combination with another endovascular procedure, e.g. angioplasty or stenting
• CPC Class Codes: A61F 2/014 Retrograde blood flow filters, i.e. device inserted against the blood flow direction
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/008 paraboloidal
• CPC Class Codes: A61F 2230/0093 Umbrella-shaped, e.g. mushroom-shaped
• CPC Class Codes: A61M 2025/0002 with a pressure sensor at the distal end
• CPC Class Codes: A61M 2025/0003 having an additional lumen transmitting fluid pressure to the outside for measurement
• CPC Class Codes: A61M 2025/0036 with more than four lumina
• CPC Class Codes: A61M 2025/004 characterized by lumina being arranged circumferentially
• CPC Class Codes: A61M 2205/3523 using telemetric means
• 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

Abstract

A combined multi-lumen central access catheter and an embolic filter including ports proximal and distal the filter for fluid infusion and/or pressure sensing and infusion ports in the catheter to permit infusion of bioactive agents, flushing agents and/or contrast agents. The embolic filter may be removably coupled to the multi-lumen catheter for temporary placement and retrieval under recommended indications.

Claims

1. A method of capturing thrombus within a blood vessel, comprising the steps of:

introducing a multi-lumen catheter having a filter member coupled thereto, wherein the filter member is circumferentially coupled about a distal region of the multi-lumen catheter and has a first end coupled circumferentially in fixed relation to the multi-lumen catheter and a second end circumferentially moveably coupled to the multi-lumen catheter, the filter member consisting of;

a plurality of struts configured to form a generally frustroconical proximal section of the filter member tapering proximally and having proximal interstitial openings, and a generally frustroconical distal section of the filter member tapering distally and having distal interstitial openings, the frustroconical proximal section having a length that is greater than or less than a length of the frustroconical distal section, each of the proximal interstitial openings having an open surface area either greater than or less than the open surface area of each of the distal interstitial openings;

where the filter member is configured to expand in a patient'"'"'s blood vessel such that a transverse dimension of the filter decreases in the direction of the patient'"'"'s blood flow to collect thrombi, wherein the vena cava filter member centers the multi-lumen catheter within a blood vessel lumen;

deploying the multi-lumen catheter within a blood vessel such that the filter member expands so that the larger interstitial openings between the frustroconical distal or proximal sections open facing a patient'"'"'s blood flow;

inserting an ultrasound imaging system operable to detect a condition of the filter member into a lumen of the multi-lumen catheter and positioning the ultrasound imaging system in a region of the multi-lumen catheter bounded by the filter member; and

imaging the filter member with the ultrasound imaging system, wherein the condition of the filter member is the presence of a thrombus in the filter member.

2. The method according to claim 1, wherein the step of imaging the filter member further comprises confirming the presence of a thrombus captured within the filter member.

3. The method according to claim 1, wherein the ultrasound imaging system is configured to be deployed by insertion into a lumen of the multi-lumen catheter to permit imaging within a region bounded by the filter member.

4. The method according to claim 3, wherein the step of inserting the imaging system into the lumen of the multi-lumen catheter further comprises disposing an imaging tip in a region of the multi-lumen catheter bounded by the filter member.

5. The method according to claim 1, wherein the step of imaging the filter member further comprises imaging the filter member from within the multi-lumen catheter;

and infusing a fluid through at least one lumen in the multi-lumen catheter in communication with at least one infusion port passing through a sidewall of the multi-lumen catheter and open to an inner spatial area bounded by the filter member.

6. A multi-lumen vena cava filter catheter, comprising:

a catheter body having a first lumen and a second lumen, the first lumen and the second lumen being separated by a portion of the catheter body, the catheter body also having a first distal opening in communication with the first lumen and a second distal opening in communication with the second lumen, wherein the first distal opening is disposed a first distance proximally from a distal end of the catheter body and the second distal opening is disposed a second distance proximally from the distal end of the catheter body;

a vena cava filter member circumferentially coupled about a distal end of the central venous line catheter body and having a first end coupled circumferentially in fixed relation to the central venous line catheter body and a second end circumferentially moveably coupled to the central venous line catheter body, the vena cava filter member consisting of a plurality of struts configured to form a generally frustroconical proximal section of the vena cava filter member tapering proximally and having proximal interstitial openings, and a generally frustroconical distal section of the vena cava filter member tapering distally and having distal interstitial openings, the frustroconical proximal section having a length that is greater than or less than a length of the frustroconical distal section, each of the proximal interstitial openings having an open surface area either greater than or less than the open surface area of each of the distal interstitial openings;

the vena cava filter member being positioned generally intermediate the first distal opening and second distal opening and configured to be expanded in a patient'"'"'s blood vessel such that a transverse dimension of the filter decreases in the direction of the patient'"'"'s blood flow to collect thrombi, wherein the vena cava filter member centers the central venous line catheter body within a blood vessel lumen; and

an ultrasound imaging system operable to detect a condition of the filter, wherein the condition of the filter member is the presence of a thrombus in the filter member.

7. The medical device according to claim 6, wherein ultrasound imaging system is configured to be deployed by insertion into a lumen of the multi-lumen catheter to permit imaging within a region bounded by the filter member.

8. The medical device according to claim 7, wherein the imaging system is configured to image the filter member in situ.

9. The medical device according to claim 6, wherein the imaging system further comprises an imaging core, a drive cable, and an imaging tip.

10. The medical device according to claim 9, wherein the imaging tip is adapted to be positioned within the multi-lumen catheter body in a region bounded by the filter member.

11. A multi-lumen vena cava filter catheter, comprising:

a catheter body having a first lumen and a second lumen, the first lumen and the second lumen being separated by a portion of the catheter body, the catheter body also having a first distal opening in communication with the first lumen and a second distal opening in communication with the second lumen, wherein the first distal opening is disposed a first distance proximally from a distal end of the catheter body and the second distal opening is disposed a second distance proximally from the distal end of the catheter body;

a vena cava filter member circumferentially coupled about a distal end of the central venous line catheter body and having a first end coupled circumferentially in fixed relation to the central venous line catheter body and a second end circumferentially moveably coupled to the central venous line catheter body, the vena cava filter member consisting of a plurality of struts configured to form a generally frustroconical proximal section of the vena cava filter member tapering proximally and having proximal interstitial openings, and a generally frustroconical distal section of the vena cava filter member tapering distally and having distal interstitial openings, the frustroconical proximal section having a length that is greater than or less than a length of the frustroconical distal section, each of the proximal interstitial openings having an open surface area either greater than or less than the open surface area of each of the distal interstitial openings;

the vena cava filter member being positioned generally intermediate the first distal opening and second distal opening and configured to be expanded in a patient'"'"'s blood vessel such that a transverse dimension of the filter decreases in the direction of the patient'"'"'s blood flow to collect thrombi, wherein the vena cava filter member centers the central venous line catheter body within a blood vessel lumen; and

a sheath having an outer wall surface and an inner wall surface, the sheath configured to be movably disposed over the catheter body and the vena cava filter member such that the sheath is longitudinally displaceable relative to the catheter body to deploy the vena cava filter member; and

an ultrasound imaging system operable to detect a condition of the filter, wherein the condition of the filter member is the presence of a thrombus in the filter member.

12. The medical device according to claim 11, wherein the ultrasound imaging system is configured to be deployed by insertion into a lumen of the multi-lumen catheter to permit imaging within a region bounded by the filter member.

13. The medical device according to claim 12, wherein the imaging system is configured to image the filter member in situ.

14. The medical device according to claim 11, wherein the imaging system further comprises an imaging core, a drive cable, and an imaging tip.

15. The medical device according to claim 14, wherein the imaging tip is adapted to be positioned within the multi-lumen catheter body in the region bounded by the filter member.