Adjustable blood filtration system

• US 6,007,557 A
• Filed: 04/29/1998
• Issued: 12/28/1999
• Est. Priority Date: 04/29/1998
• Status: Expired due to Term

• Current Assignee: Edwards Lifesciences Corporation
• Original Assignee: Embol X Inc (Edwards Lifesciences Corporation)
• Inventors: Wood, Timothy J., Turovskiy, Roman, Ambrisco, William M., Maahs, Tracy D., Addis, Bruce S., Murphy, Richard O.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US09/070,660
• Time in Patent Office: 608 Days
• Field of Search: 606/200, 606/213, 606/108, 606/159, 606/151, 606/170, 606/171, 606/195, 606/198, 604/104, 604/284
• US Class Current: 606/200
• CPC Class Codes: A61B 90/06 Measuring instruments not otherwise provided for
• 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 2/011 Instruments for their placement or removal
• CPC Class Codes: A61F 2/012 Multiple filtering units
• CPC Class Codes: A61F 2002/018 made from tubes or sheets of material, e.g. by etching or laser-cutting
• CPC Class Codes: A61F 2230/0006 circular
• CPC Class Codes: A61F 2230/0067 conical
• CPC Class Codes: A61F 2230/0071 spherical
• CPC Class Codes: A61F 2230/0076 ellipsoidal or ovoid
• CPC Class Codes: A61F 2230/008 paraboloidal

Abstract

A modular blood filter device and delivery system, comprising a hollow vessel insertion device with a modular filter apparatus. The insertion device, which can be an introducer, includes a distal end adapted to enter an artery, and a proximal end adapted to receive a modular filter apparatus. When the insertion device is a cannula, the modular filter apparatus is received through a side port. The modular filter apparatus includes a shaft and an adjustable filter device or a removable filter associated with the shaft. The adjustable filter includes filter mesh, an adjustable flame capable of assuming enlarged and contracted conditions and a frame sizing mechanism associated with the frame. Certain embodiments include a filter cartridge, and the shaft is inserted into the cartridge, thereby protecting the adjustable filter device therein. The cartridge may then be removably received by the insertion device. An expandable obturator may be used to ease the entry of the insertion device into the vessel. Indexing and locking mechanisms are described for aligning the cartridge or the obturator to the insertion device. Vessel sizing tools are also described for determining the size of the vessel into which the filter will be introduced. The insertion device may then be introduced into a blood vessel, and the adjustable filter device may be deployed through the device into the vessel The adjustable frame may be self-adjusting or externally adjusted to fit the vessel and to capture embolic material in the mesh. The frame may be collapsed to the contracted condition, and may be removed from the vessel or embolic debris may be removed by an aspiration tube. The modular filter cartridge may be removed from the cannula, and a new modular filter cartridge may then be received therein.

Claims

1. A modular filter apparatus for insertion into a hollow vessel insertion device for filtering embolic material from a blood vessel into which the insertion device is introduced, said modular filter apparatus comprising:

a shaft having a proximal end and a distal end including a release mechanism;

an adjustable filter frame removably-mounted on the release mechanism the distal end of the shaft, said adjustable filter frame adjustable between a contracted condition and an enlarged condition and having a diameter and an interior area; and

a filter mesh coupled to the adjustable filter frame for capturing embolic material,

wherein the modular filter apparatus is removably insertable into said hollow vessel insertion device, and, upon insertion through the hollow vessel device into the vessel, said adjustable filter frame adjusts the diameter of the adjustable filter frame to conform to the inner lumen of the vessel, and

wherein said adjustable filter frame and filter mesh coupled thereto may be demounted from the shaft.

2. The modular filter apparatus of claim 1, further comprising a tubular cartridge having a lumen for receiving the distal end of the shaft and protecting the adjustable filter frame and filter mesh thereon, the tubular cartridge removably insertable into the hollow vessel insertion device.

3. The modular filter apparatus of claim 2, wherein the shaft has a cross-section shape selected from the group consisting of oval, rectangular and triangular, and wherein the lumen of the tubular cartridge conforms to the shape of the cross-section of the shaft to inhibit rotation of the shaft within the tubular cartridge.

4. The modular filter apparatus of claim 2, further comprising a hemostatic seal between the tubular cartridge and the hollow vessel insertion device into which the cartridge may be inserted.

5. A modular filter apparatus for insertion into a hollow vessel insertion device for filtering embolic material from a blood vessel into which the hollow vessel insertion device is introduced, said modular filter apparatus comprising:

a shaft having a proximal end and a distal end;

an adjustable filter frame disposed about the distal end of the shaft, which is adjustable between a contracted condition and an enlarged condition, said adjustable filter frame having a diameter and an interior area;

a frame sizing mechanism associated with said adjustable filter frame wherein the adjustable filter frame automatically self-adjusts to fit the lumen of the vessel; and

a filter mesh coupled to the adjustable filter frame for capturing embolic material,

wherein the modular filter apparatus is removably insertable into said hollow vessel insertion device, and, upon insertion through the hollow vessel insertion device into the artery, said frame sizing mechanism adjusts the diameter of the adjustable filter frame to conform to the inner lumen of the vessel.

6. The modular filter apparatus of claim 5, further comprising a tubular cartridge having a lumen for receiving the distal end of the shaft and protecting the adjustable filter frame and filter mesh thereon, the tubular cartridge removably insertable into the hollow vessel insertion device.

7. The modular filter apparatus of claim 6, further comprising a hemostatic seal between the tubular cartridge and the hollow vessel insertion device into which the cartridge may be inserted.

8. The modular filter apparatus of claim 6, wherein the shaft has a cross-section shape selected from the group consisting of oval, rectangular and triangular, and wherein the lumen of the tubular cartridge conforms to the shape of the cross-section of the shaft to inhibit rotation of the shaft within the tubular cartridge.

9. The modular filter apparatus of claim 6, wherein said frame sizing mechanism is self-adjusting upon advancement of the adjustable filter frame into the lumen of the vessel.

10. The modular filter apparatus of claim 5, wherein said adjustable filter frame has a proximal region and a distal region, the modular filter apparatus further comprising a cantilever beam having a proximal end, a distal end and a cross-section, said distal end of the cantilever beam associated with the distal region of the adjustable filter frame and said proximal end of the cantilever beam associated with the distal end of said shaft.

11. The modular filter apparatus of claim 10, wherein said proximal region of the adjustable filter frame is associated with the distal end of the shaft.

12. The modular filter apparatus of claim 10, wherein said proximal region of the adjustable filter frame is associated with the proximal end of the cantilever beam.

13. The modular filter apparatus of claim 10, wherein the proximal end of the cantilever beam is coupled to the distal end of the shaft.

14. The modular filter apparatus of claim 10, wherein the shaft has a lumen which extends from the proximal end to an opening in the distal end, and wherein the proximal end of the cantilever beam is slidably insertable into said opening in the distal end of the shaft.

15. The modular filter apparatus of claim 14, wherein the shape of said cross-section of the cantilever beam is selected from the group consisting of oval, rectangular and triangular, and the opening in the distal end of the shaft is of a shape that conforms to the shape of the cross-section of the cantilever beam, and wherein, during use, the shape of the opening in the distal end of the shaft and the shape of the cross-section of the cantilever beam inhibit rotation of the cantilever beam in the lumen of the shaft.

16. The modular filter apparatus of claim 10, further comprising a tubular cartridge for receiving the distal end of the shaft and protecting the adjustable filter frame and filter mesh thereon, the cartridge being removably insertable into the hollow vessel insertion device.

17. The modular filter apparatus of claim 5, wherein said filter mesh is of a generally elongated conical shape having an inner surface and an apex.

18. The modular filter apparatus of claim 17, the modular filter apparatus further comprising a filter mesh-occluded sac having an inner surface, said filter mesh-occluded sac coupled to said apex of the filter mesh, and wherein, during use, embolic debris is trapped in said filter mesh-occluded sac for later removal.

19. The modular filter apparatus of claim 5, wherein said filter mesh has a proximal region and a distal region having an apex, wherein the filter mesh in said proximal region is occluded, and wherein, during use, the proximal mesh-occluded region causes the blood to flow through the distal region thereby forcing embolic debris to become trapped in the apex of the filter mesh.

20. The modular filter apparatus of claim 6, wherein said shaft has a proximal region, a proximal end with an opening, a distal end with an opening, and a lumen therebetween, said modular filter apparatus further comprising:

a cartridge sleeve having a proximal region, a proximal end with an opening and a distal end with an opening and a lumen therebetween, said cartridge sleeve adapted to sealably receive the tubular cartridge, the proximal end of the tubular cartridge distal to the proximal region of the cartridge sleeve;

a seal disposed about the outer surface of the proximal region of the shaft, proximal to the proximal end of the tubular cartridge and distal to the proximal end of the cartridge sleeve, said cartridge sleeve slidably and sealably receiving said shaft in the region of the seal;

a shaft cap having a proximal and a distal opening and a lumen therebetween, said distal opening adapted to sealably receive the proximal end of the shaft and said proximal opening adapted to sealably receive a plug; and

a gas-permeable plug adapted to sealably insert in said proximal end of said shaft cap, and

wherein during use, the opening in the proximal end of the shaft allows fluid to escape the shaft lumen and pass into the shaft cap and the gas-permeable plug allows gas, but not liquid to escape the shaft cap.

21. A blood filtering system, comprising:

a hollow vessel insertion device capable of receiving a modular filter apparatus for capturing embolic material in a blood vessel, the hollow vessel insertion device comprising an elongated tube having an outer surface, a distal region, a distal end adapted to enter a vessel, a proximal end and a lumen therebetween; and

a modular filter apparatus for insertion into said hollow vessel insertion device, said modular filter apparatus comprising;

a shaft having a proximal end and a distal end;

an adjustable frame disposed about the distal end of the shaft, which is expandable between a contracted condition and an enlarged condition;

a frame sizing mechanism associated with said adjustable frame wherein the adjustable frame automatically self-adjusts to fit the lumen of the vessel; and

a filter mesh coupled to the adjustable frame for capturing embolic material,

wherein, the modular filter apparatus is removably insertable into the hollow vessel insertion device, and, upon insertion through the hollow vessel insertion device and into said vessel said frame sizing mechanism adjusts the diameter of the adjustable filter frame to conform to the inner lumen of the vessel.

22. The blood filtering system of claim 21, wherein the hollow vessel insertion device is an arterial cannula further comprising:

a proximal end adapted to receive blood from a bypass oxygenator machine; and

a port for receiving said modular filter apparatus.

23. The blood filtering system of claim 21, wherein the hollow vessel insertion device is an introducer.

24. The blood filtering system of claim 21, wherein said modular filter apparatus further comprises a tubular cartridge for receiving the distal end of the shaft and protecting the adjustable frame and filter mesh thereon, the tubular cartridge removably insertable into the hollow vessel insertion device.

25. The blood filtering system of claim 21, said modular filter apparatus further comprising:

a tubular filter cartridge, slidably insertable into the hollow vessel insertion device, said tubular cartridge adapted to slidably receive the distal end of the shaft and protect the adjustable frame and filter mesh thereon, the tubular cartridge having a distal region, an outer surface and a guide mechanism coupled to said outer surface of the tubular cartridge in the distal region;

said hollow vessel insertion device having a proximal end, a distal end, a proximal region, a circumference and a lumen which extends from an opening in said proximal end to an opening in said distal end, the hollow vessel insertion device further comprising;

a slot in the proximal region adapted to receive the guide mechanism of the tubular cartridge when the tubular cartridge is slidably inserted into the hollow vessel insertion device, and

wherein, during use, the tubular cartridge is rotated as it is advanced into the hollow vessel insertion device until the guide mechanism of the tubular cartridge aligns with and engages slot in the hollow vessel insertion device aligning the tubular cartridge with the hollow vessel insertion device.

26. The blood filtering system of claim 25, wherein said guide mechanism is a guide tab projecting axially and parallel to the outer surface of the tubular cartridge.

27. The blood filtering system of claim 25, the tubular cartridge further comprising an elongated member having a proximal and a distal end, said proximal end coupled to said outer surface of said distal region of said tubular cartridge, said distal end having a hook;

and

the hollow vessel insertion device further comprising a shelf overhanging the opening in the proximal end, said shelf adapted to engage said hook, and

wherein during use, said elongated member of the tubular cartridge is operated to slide the hook under the shelf of the hollow vessel insertion device and lock the tubular cartridge to the hollow vessel insertion device, and

wherein, once engaged, said elongated member is operated to disengage said hook from said shelf and unlock the tubular cartridge from the hollow vessel insertion device.

28. The blood filtering system of claim 27, wherein said elongated member is a first elongated member, said blood filtering system further comprising a second elongated member having a proximal and a distal end, said proximal end coupled to said outer surface of said distal region of said tubular cartridge, said distal end having a hook.