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

• US 8,613,753 B2
• Filed: 01/08/2010
• Issued: 12/24/2013
• 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:
  US12/684,839
• Publication Number:
  US 20100217304A1
• Time in Patent Office: 1,446 Days
• Field of Search: 606/200, 606/127, 606/128, 623/1.11, 604106-107
• US Class Current: 606/200
• 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 central line vena cava filter catheter medical device, comprising:

a central venous line catheter body having a first opening in communication with a first fluid flow lumen, and a second opening in communication with a second fluid flow lumen; and

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 opening and second 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.

2. The central line vena cava filter catheter medical device according to claim 1, further comprising a sensor operably associated with at least one of the first and the second openings.

3. The central line vena cava filter catheter medical device according to claim 2, wherein the sensor is selected from the group of pressure sensors, flow sensors, analyte sensors, thermal sensors and optical sensors.

4. The central line vena cava filter catheter medical device according to claim 2, further comprising a wireless transmitter operably associated with the sensor and a wireless receiver remote from a patient'"'"'s body to wirelessly receive data from the sensor.

5. The central line vena cava filter catheter medical device according to claim 1, further comprising a flow sensor operably associated with at least one of the first and second openings, wherein the flow sensor detects fluid flow velocities as the medical device is passed through an anatomical passageway.

6. The central line vena cava filter catheter medical device according to claim 5, further comprising a wireless transmitter operably associated with the flow sensors and a wireless receiver remote from a patient'"'"'s body to wirelessly receive data from the flow sensors.

7. The central line vena cava filter catheter medical device according to claim 1, further comprising at least one infusion port associated with at least one infusion lumen in the central venous line catheter body.

8. The central line vena cava filter catheter medical device according to claim 7, wherein the at least one infusion port further comprises a plurality of infusion ports arrayed along a longitudinal axis and a circumferential axis of the central venous line catheter body.

9. The central line vena cava filter catheter medical device according to claim 1, wherein the first end of the vena cava filter member is immovably fixed to the central venous line catheter body.

10. The central line vena cava filter catheter medical device according to claim 1, wherein some of the plurality of struts are configured to form a circumferential portion coupling a distal end of the generally frustroconical proximal section to a proximal end of the generally frustroconical distal section.

11. The central line vena cava filter catheter medical device according to claim 10, wherein some of the plurality of struts in the circumferential portion form a generally sinusoidal-shaped member having a plurality of peaks and valleys.

12. The central line vena cava filter catheter medical device according to claim 11, wherein the plurality of struts forming the generally frustroconical proximal section and the plurality of struts forming generally frustroconical distal section are connected to corresponding peaks and valleys of the generally sinusoidal-shaped member.

13. The central line vena cava filter catheter medical device according to claim 1, further comprising an introducer sheath through which the central venous line catheter body and the vena cava filter member are introduced and delivered to a situs within a patient'"'"'s body.

14. The central line vena cava filter catheter medical device according to claim 13, further comprising at least one radio-opaque marker proximate a distal end of the introducer sheath and at least one radio-opaque marker proximate a distal end of the central venous line catheter body.

15. The central line vena cava filter catheter medical device according to claim 1, further comprising a central guidewire lumen passing longitudinally along a central longitudinal axis of the central venous line catheter body.

16. The central line vena cava filter catheter medical device according to claim 1, further comprising an outer sheath concentrically disposed about the central venous line catheter body wherein the central venous line catheter body and the outer sheath are moveable relative to one another, the outer sheath being capable of permitting the vena cava filter member to diametrically expand when the outer sheath is refracted and diametrically contract when the outer sheath is extended relative to the central venous line catheter body.

17. The central line vena cava filter catheter medical device according to claim 1, wherein at least some of the plurality of struts of the frustroconical proximal section are offset from each other about 120 degrees about the circumference of the frustroconical proximal section.

18. The central line vena cava filter catheter medical device according to claim 1, wherein at least some of the plurality of struts of the frustroconical distal section are offset from each other about 120 degrees about the circumference of the frustroconical distal section.

19. The central line vena cava filter catheter medical device according to claim 1, wherein the open surface area of the plurality of proximal interstitial openings is greater than the open surface area of the plurality distal interstitial openings.

20. The central line vena cava filter catheter medical device according to claim 1, wherein the open surface area of the plurality of proximal interstitial openings is less than the open surface area of the plurality of distal interstitial openings.

21. An indwelling and removable vena cava filter medical device, comprising:

a catheter body having a first opening in communication with a first fluid flow lumen, and a second opening in communication with a second fluid flow lumen; and

an asymmetrical vena cava filter member positioned generally intermediate the first and second openings of the catheter body and consisting of a plurality of strut members defining interstitial open areas between the strut members and the plurality of strut members configured to form a generally conical proximal filter section and a generally conical distal filter section, the generally conical proximal filter section having a first lateral length, a first height, a first base and an apex projecting proximally relative to the catheter body member and the first base, and the generally conical distal filter section having a second lateral length different from the first lateral length, a second height different from the first height and an apex projecting generally distally relative to the catheter body member and a second base, the generally conical proximal filter section having a plurality of interstitial openings defining an open surface area between the strut members that is different from an open surface area between the strut members of the generally conical distal filter section and the first base and the second base are conjoined about a common circumferential axis;

the asymmetrical vena cava filter member being circumferentially coupled about a distal end of the catheter body such that the catheter body passes through the apices of each of the first generally conical proximal filter section and the second generally conical distal filter section, with the generally conical proximal cone section being fixedly coupled in circumferential relation to the catheter body and the generally conical distal filter section being moveably and substantially circumferentially coupled to the catheter body, the filter member configured such that the generally conical distal cone filter section translates along a longitudinal axis of the catheter body during diametric expansion or contraction of the asymmetrical vena cava filter member;

wherein the asymmetrical vena cava filter member centers the central venous line catheter body within a blood vessel lumen.

22. The indwelling and removable vena cava filter medical device according to claim 21, further comprising an outer sheath concentrically disposed about the catheter body wherein the catheter body and the outer sheath are moveable relative to one another.

23. The indwelling and removable vena cava filter medical device according to claim 22, wherein the catheter body, the asymmetrical vena cava filter member and the outer sheath form an assembly that is adapted to remain in-dwelling within a patient'"'"'s body for a pre-determined period of time, and, thereafter, be removably withdrawn as the assembly from the patient'"'"'s body.

24. The indwelling and removable vena cava filter medical device according to claim 23, further comprising a sensor operably associated with at least one of the first and the second openings.

25. The indwelling and removable vena cava filter medical device according to claim 23, wherein the sensor is selected from the group of pressure sensors, flow sensors, analyte sensors, thermal sensors and optical sensors.

26. The indwelling and removable vena cava filter medical device according to claim 23, further comprising a flow sensor operably associated with at least one of the first and second openings, wherein the flow sensor detects fluid flow velocities as the medical device is passed through an anatomical passageway.

27. The indwelling and removable vena cava filter medical device according to claim 23, wherein generally conical proximal filter section of the vena cava filter member further consists of exactly three strut members that extend from the first base to the apex of the generally conical proximal filter section.

28. The indwelling and removable vena cava filter medical device according to claim 21 wherein the first lateral length is greater than the second lateral length.

29. The indwelling and removable vena cava filter medical device according to claim 21 wherein the second lateral length is greater than the first lateral length.

30. The indwelling and removable vena cava filter medical device according to claim 21 wherein the first height is greater than the second height.

31. The indwelling and removable vena cava filter medical device according to claim 21 wherein the second height is greater than the first height.

32. The indwelling and removable vena cava filter medical device according to claim 21 wherein the open surface area of the plurality of interstitial openings of the generally conical proximal filter section is greater than the open surface area of the plurality of interstitial openings of the generally conical distal filter section.

33. The indwelling and removable vena cava filter medical device according to claim 21 wherein the open surface area of the plurality of interstitial openings of the generally conical proximal filter section is less than the open surface area of the plurality of interstitial openings of the generally conical distal filter section.