Recovery Catheter Assembly

• US 20110282274A1
• Filed: 03/04/2011
• Published: 11/17/2011
• Est. Priority Date: 03/06/2010
• Status: Active Grant

• Current Assignee: Nfusion Vascular Systems LLC
• Original Assignee: Nfusion Vascular Systems LLC
• Inventors: Fulton, Richard Eustis III
• Granted Patent: US 8,679,057 B2
• Time in Patent Office: Days
• US Class Current: 604/28
• CPC Class Codes: A61B 17/12036 partial occlusion
• CPC Class Codes: A61B 17/12045 double occlusion, e.g. during anastomosis
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12136 Balloons
• CPC Class Codes: A61B 17/12168 having a mesh structure A61B17/1214 takes precedence
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2090/065 for measuring contact or contact pressure
• CPC Class Codes: A61B 5/02152 specially adapted for venous pressure
• 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: A61M 1/34 Filtering material out of the blood by passing it through a membrane, i.e. hemofiltration or diafiltration
• CPC Class Codes: A61M 1/3403 Regulation parameters
• CPC Class Codes: A61M 1/36 Other treatment of blood in a by-pass of the natural circulatory system, e.g. temperature adaptation, irradiation ; Extra-corporeal blood circuits
• CPC Class Codes: A61M 1/3615 Cleaning blood contaminated by local chemotherapy of a body part temporarily isolated from the blood circuit
• CPC Class Codes: A61M 1/367 Circuit parts not covered by the preceding subgroups of group A61M1/3621
• CPC Class Codes: A61M 1/3679 by absorption A61M1/3675 takes precedence
• 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 2025/1052 for temporarily occluding a vessel for isolating a sector
• 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 25/007 Side holes, e.g. their profiles or arrangements; Provisions to keep side holes unblocked
• CPC Class Codes: A61M 25/0074 Dynamic characteristics of the catheter tip, e.g. openable, closable, expandable or deformable
• CPC Class Codes: A61M 25/0082 : Catheter tip comprising a tool
• CPC Class Codes: A61M 25/04 : in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence
• 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 60/113 : in other functional devices, e.g. dialysers or heart-lung machines
• CPC Class Codes: A61M 60/13 : by means of a catheter allowing explantation, e.g. catheter pumps temporarily introduced via the vascular system
• CPC Class Codes: A61M 60/148 : in line with a blood vessel using resection or like techniques, e.g. permanent endovascular heart assist devices
• CPC Class Codes: A61M 60/216 : including a rotating member acting on the blood, e.g. impeller
• CPC Class Codes: A61M 60/31 : for enhancement of in vivo organ perfusion, e.g. retroperfusion
• CPC Class Codes: A61M 60/36 : for specific blood treatment; for specific therapy
• CPC Class Codes: A61M 60/554 : of blood pressure
• CPC Class Codes: A61M 60/833 : Occluders for preventing backflow
• CPC Class Codes: A61M 60/861 : Connections or anchorings for connecting or anchoring pumps or pumping devices to parts of the patient's body

Abstract

An example of recovery catheter assembly comprises an actuator element and a mechanically radially expandable and contractible recovery device operably connected to the actuator element. The recovery device has proximal and distal blocking portions and a central portion therebetween. The recovery device is at least partially placeable in a first, radially collapsed configuration and in a second, radially expanded configuration by manipulation of the actuator element. When in the second, radially expanded configuration, the proximal and distal blocking portions have radial dimensions greater than the radial dimension of the central portion thereby at least partially defining a collection chamber at the central portion.

Claims

1. A recovery catheter assembly comprising:

an actuator element;

a mechanically radially expandable and contractible recovery device operably connected to the actuator element, the recovery device having proximal and distal ends;

the recovery device comprising;

proximal and distal blocking portions at the proximal and distal ends thereof; and

a central portion between the proximal and distal blocking portions;

the recovery device at least partially placeable in a first, radially collapsed configuration and in a second, radially expanded configuration by manipulation of the actuator element so that when in the second, radially expanded configuration the proximal and distal blocking portions have radial dimensions greater than the radial dimension of the central portion thereby at least partially defining a collection chamber at the central portion.

2. The assembly according to claim 1, wherein the recovery device is fully placeable in the first, radially collapsed configuration and in the second, radially expanded configuration by manipulation of the actuator element.

3. The assembly according to claim 1, wherein the recovery device comprises a mesh braid.

4. The assembly according to claim 3, wherein the proximal extension element comprises a plurality of radially and axially extending elements, said radially and axially extending elements being extensions of said mesh braid.

5. The assembly according to claim 3, wherein each of the proximal and distal extension elements comprises a plurality of radially and axially extending elements, said radially and axially extending elements being extensions of said mesh braid.

6. The assembly according to claim 3, wherein the collection chamber is defined by the proximal and distal blocking portions and the central portion comprises an elastomeric material on said mesh braid.

7. The assembly according to claim 1, wherein:

the recovery device comprises proximal and distal toroidal blocking balloons at the proximal and distal ends of the recovery device;

the recovery device is placeable in the first, radially collapsed configuration when (1) the blocking balloons are in deflated states, and (2) the actuator element is in a collapsed actuation state; and

the recovery device is placeable in the second, radially expanded configuration when (1) the blocking balloons are in inflated states, and (2) the actuator element is in an expanded actuation state.

8. The assembly according to claim 1, further comprising:

a hollow recovery catheter having a sidewall and defining a recovery lumen.

9. The assembly according to claim 8, further comprising:

a lateral passageway extending through the central portion of the recovery device and the sidewall of the recovery catheter, the parts of the proximal and distal blocking portions and the central portion at least partially defining the collection chamber being liquid impervious with the exception of the passageway;

whereby liquid in the collection chamber can pass through the passageway and into and through the recovery lumen.

10. The assembly according to claim 9, wherein:

the recovery catheter comprises proximal, intermediate and distal portions;

the lateral passageway is located along the intermediate portion of the recovery catheter;

a blood pump located along the distal portion of the recovery catheter; and

a filter element located along the distal portion of the recovery catheter for filtering out at least one agent from fluid flow through the recovery catheter lumen.

11. The assembly according to claim 8, further comprising:

a first pressure sensor at the collection chamber;

a second pressure sensor positioned distal of the recovery device;

a filter element and a pump operably coupled to the recovery catheter to pump fluid through the recovery catheter and filter fluid passing through the recovery catheter; and

the pump operably coupled to the first and second pressure sensors to permit control of the pressure within the collection chamber during use.

12. The assembly according to claim 8, further comprising:

a filter element and a pump operably coupled to the recovery catheter to pump fluid through the recovery catheter and filter fluid passing through the recovery catheter;

a pressure sensor proximal to the pump; and

the pump operably coupled to the pressure sensor to permit control of the pressure within the collection chamber during use.

13. The assembly according to claim 1, wherein:

the actuator element comprises first and second actuator elements;

the recovery device comprises a proximal end operably connected to the first actuator element and a distal end operably connected to the second actuator element; and

the recovery device being at least partially placeable in the first, radially collapsed configuration and in the second, radially expanded configuration by manipulation of the first and second actuator elements.

14. The assembly according to claim 13, wherein the recovery device is fully placeable in the first, radially collapsed configuration and in the second, radially expanded configuration by manipulation of the first and second actuator elements.

15. The assembly according to claim 13, wherein the second actuator element comprises an actuator wire.

16. The catheter assembly according to claim 13, further comprising:

a hollow recovery catheter having a sidewall, the recovery catheter defining a recovery lumen, the recovery catheter having a distal end; and

wherein;

the first actuator element has a distal portion; and

the second actuator element extends along the recovery catheter and has a tip positioned distal of the distal end of the recovery catheter.

17. The assembly according to claim 16, wherein the first actuator element comprises an outer actuator sheath with the recovery catheter slideably housed within the actuator sheath.

18. The catheter assembly according to claim 16 further comprising:

a lateral passageway extending through the central portion of the recovery device and the sidewall of the recovery catheter, the parts of the proximal and distal blocking portions and the central portion at least partially defining the collection chamber being liquid impervious with the exception of the passageway;

whereby liquid in the collection chamber can pass through the passageway and into and through the recovery lumen.

19. The catheter assembly according to claim 16, wherein the proximal end of the recovery device is secured to the distal portion of the first actuator element by a proximal extension element and the distal end is secured to the tip of the second actuator element by a distal extension element.

20. The assembly according to claim 19, wherein the proximal extension element comprises a plurality of radially and axially extending elements.

21. The catheter assembly according to claim 19, wherein:

the recovery device comprises a return lumen extending between the proximal and distal ends of the recovery device; and

the proximal and distal expansion elements having open regions to permit fluid flow through the return lumen of the recovery device when the recovery device is in the second, radially expanded configuration.

22. The assembly according to claim 13, wherein:

the recovery device comprises proximal and distal toroidal blocking balloons at the proximal and distal ends of the recovery device;

the first actuator element comprises an actuator sheath and the second actuator element comprises an actuator wire;

the recovery device is placeable in the first, radially collapsed configuration when (1) the blocking balloons are in deflated states, and (2) the actuator wire is pushed distally to a distal actuator wire position relative to the recovery device and the actuator sheath is pulled proximally to a proximal actuator sheath position relative to the recovery device; and

the recovery device is placeable in the second, radially expanded configuration when (1) the blocking balloons are in inflated states, and (2) the actuator wire is pulled proximally to a proximal actuator wire position relative to the recovery device and the actuator sheath is pushed distally to a distal actuator sheath position relative to the recovery device.

23. The assembly according to claim 22, wherein the recovery device defines a longitudinal axis and the toroidal blocking balloons are obliqued balloons oriented at an acute angle to the longitudinal axis to help prevent inadvertent occlusion of an ostium.

24. The assembly according to claim 1, wherein the recovery device defines a return channel between the proximal and distal ends when in the second, radially expanded configuration.

25. A recovery catheter assembly, for use within a body passageway at an ostium, comprising:

an outer, actuator sheath having a distal portion;

an inner, hollow recovery catheter having a sidewall, the recovery catheter defining a recovery lumen, the recovery catheter housed within the actuator sheath, the recovery catheter having a distal end;

an actuator wire extending along the recovery catheter and having a tip positioned distal of the distal end of the recovery catheter;

a mechanically radially expandable and contractible recovery device having a proximal end secured to the distal portion of the actuator sheath by a proximal extension element and a distal end secured to the tip of the actuator wire by a distal extension element;

the recovery device comprising;

proximal and distal blocking portions at the proximal and distal ends thereof;

a central portion between the proximal and distal blocking portions; and

a return channel extending between the proximal and distal ends thereof;

the recovery device placeable in a first, radially collapsed configuration when the actuator wire is pushed distally to a distal actuator wire position relative to the recovery device and the actuator sheath is pulled proximally to a proximal actuator sheath position relative to the recovery device;

the recovery device placeable in a second, radially expanded configuration when the actuator wire is pulled proximally to a proximal actuator wire position relative to the recovery device and the actuator sheath is pushed distally to a distal actuator sheath position relative to the recovery device;

when in the second, radially expanded configuration;

the proximal and distal blocking portions having radial dimensions greater than the radial dimension of the central portion thereby defining a collection chamber at the central portion; and

the proximal and distal expansion elements having open regions to permit fluid flow through the return channel of the recovery device; and

a lateral passageway extending through the central portion of the recovery device and the sidewall of the recovery catheter, the parts of the proximal and distal blocking portions and the central portion defining the collection chamber being liquid impervious with the exception of the passageway;

whereby liquid from an ostium of a liquid transporting vessel opening into the collection chamber can pass through the passageway and into and through the recovery lumen.

26. A recovery catheter assembly, for use within a body passageway at an ostium, comprising:

an outer, actuator sheath having a distal portion;

an inner, hollow recovery catheter having a sidewall, the recovery catheter defining a recovery lumen, the recovery catheter housed within the actuator sheath, the recovery catheter having a distal end;

an actuator wire extending along the recovery catheter and having a tip positioned distal of the distal end of the recovery catheter;

a mechanically radially expandable and contractible recovery device having a proximal end secured to the distal portion of the actuator sheath by a proximal extension element and a distal end secured to the tip of the actuator wire by a distal extension element;

the recovery device comprising;

proximal and distal toroidal blocking balloons at the proximal and distal ends thereof;

a central portion between the proximal and distal blocking portions; and

a return channel extending between the proximal and distal ends;

the recovery device placeable in a first, radially collapsed configuration when (1) the blocking balloons are in deflated states, and (2) the actuator wire is pushed distally to a distal actuator wire position relative to the recovery device and the actuator sheath is pulled proximally to a proximal actuator sheath position relative to the recovery device;

the recovery device placeable in a second, radially expanded configuration when (1) the blocking balloons are in inflated states, and (2) the actuator wire is pulled proximally to a proximal actuator wire position relative to the recovery device and the actuator sheath is pushed distally to a distal actuator sheath position relative to the recovery device;

when in the second, radially expanded configuration;

the proximal and distal blocking balloons having radial dimensions greater than the radial dimension of the central portion thereby defining a collection chamber at the central portion; and

the proximal and distal expansion elements having open regions to permit fluid flow through the return channel of the recovery device; and

a lateral passageway extending through the central portion of the recovery device and the sidewall of the recovery catheter, the parts of the proximal and distal blocking portions and the central portion defining the collection chamber being liquid impervious with the exception of the passageway;

whereby liquid from an ostium of a liquid transporting vessel opening into the collection chamber can pass through the passageway and into and through the recovery lumen.

27. The assembly according to claim 26, wherein the recovery device defines a longitudinal axis and the toroidal blocking balloons are obliqued balloons oriented at an acute angle to the longitudinal axis to help prevent inadvertent occlusion of an ostium.

28. A method for directing a fluid, which passes through an ostium into a body passageway, to a fluid recovery device comprising:

positioning a radially expandable and contractible recovery device within a body passageway at an ostium with the recovery device in a first, radially collapsed configuration, the recovery device having a proximal end and a distal end;

placing the recovery device in a second, radially expanded configuration, the placing step carried out at least in part by the mechanical manipulation of at least one mechanical actuator element thereby mechanically expanding the proximal and distal blocking portions so that when the recovery device is in the second, radially expanded configuration, the proximal and distal blocking portions having radial dimensions greater than the radial dimension of the central portion thereby at least partially defining a collection chamber at the central portion; and

flowing fluid from the collection chamber into the recovery device.

29. The method according to claim 28, wherein the radially expanded configuration placing step is carried out using first and second mechanical actuator elements operably coupled to proximal and distal ends of the recovery device.

30. A method according to claim 28, wherein the radially expanded configuration placing step is carried out completely by the mechanical manipulation of the at least one actuator element.

31. The method according to claim 28, wherein the radially expanded configuration placing step further comprises inflating proximal and distal toroidal blocking balloons at the proximal and distal ends of the recovery device.

32. The method according to claim 28, wherein the fluid flowing step comprises flowing the fluid through a lateral passageway in the central portion of the recovery device and into a recovery catheter extending into the recovery device.

33. The method according to claim 28, further comprising permitting fluid flow from the body passageway, through one of the proximal and distal ends of the recovery device, through a return lumen defined within the recovery device, and back into the body passageway through the other of the proximal and distal ends of the recovery device.

34. A method for recovering venous effluent from an organ, the organ having a distal vein and a draining vein, comprising:

placing a funnel device of a recovery catheter assembly within a tubular body vessel at a venous ostium of an organ being treated, the funnel device having an open end;

placing the open end of the funnel device within the distal vein of the organ at the ostium;

forcing the funnel device against the venous wall to create a seal between the funnel device and the draining vein thereby creating a collection chamber defined between the funnel device and the organ;

infusing an agent into the patient;

collecting fluid from the organ in the collection chamber;

filtering the collected fluid; and

returning the filtered collected fluid to the patient.

35. The method according to claim 34, wherein the forcing step comprises expanding an expansion element against the funnel device.

36. The method according to claim 34, wherein the placing step is carried out with the organ being the liver.

37. The method according to claim 34, wherein the filtering step is carried out externally of the patient.

38. The method according to claim 34, wherein the fluid collecting step collects a fluid comprising blood and the agent, and the filtering step filters out the agent.

39. A method for determining the effectiveness of a seal at a collection chamber created between a recovery device of a recovery catheter assembly and an organ from which fluid is collected, comprising:

infusing an indicator agent and a therapeutic agent into a patient;

collecting a fluid, which passes through an ostium of an organ into a body passageway, in a collection chamber defined between a fluid recovery device of a recovery catheter assembly and the organ;

processing the collected fluid, the processing step comprising removing the indicator agent and the therapeutic agent from the collected fluid;

returning the processed fluid to the patient;

collecting systemic fluid from the patient; and

testing the collected systemic fluid for the presence of the indicator agent.

40. A method for removing a therapeutic agent from a patient comprising:

infusing a therapeutic agent into a patient;

collecting a fluid passing from an organ;

adding a binding material comprising an affinity agent into the collected fluid;

binding the therapeutic agent within the collected fluid to the affinity agent;

processing the collected fluid and the binding material, the processing step comprising removing the binding material with the therapeutic agent bound thereto from the collected fluid; and

returning the processed fluid to the patient.

41. The method according to claim 40, wherein the fluid collecting step comprises collecting the fluid, which passes through an ostium of an organ into a body passageway, in a collection chamber defined between a fluid recovery device of a recovery catheter assembly and the organ.