Removable embolus blood clot filter

• US 6,007,558 A
• Filed: 09/25/1998
• Issued: 12/28/1999
• Est. Priority Date: 09/25/1998
• Status: Expired due to Term

• Current Assignee: C.R. Bard, Inc. (Becton, Dickinson & Co)
• Original Assignee: Nitinol Medical Technologies Incorporated
• Inventors: Ravenscroft, Adrian C., Kleshinski, Stephen J.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): PHAM, THUY D
• Application Number:
  US09/160,384
• Time in Patent Office: 459 Days
• Field of Search: 606/200, 606/191, 606/194, 606/127, 606/198, 623/1
• 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 2/012 Multiple filtering units
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2002/8483 Barbs
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0067 conical

Abstract

A blood clot filter which is collapsible toward a central longitudinal axis into a collapsed configuration for insertion into a blood vessel and which is radially expandable outwardly from the longitudinal axis to an expanded configuration for contact with the inner wall of the blood vessel at two longitudinal spaced locations. A first plurality of spaced, elongate arms, in the expanded configuration of the filter, curve outwardly away from the longitudinal axis toward the leading end of the filter to form a first filter basket and to center a hub at the trailing end of the filter within the vessel. A second plurality of spaced elongate legs angle outwardly away from the longitudinal axis toward the leading edge of the filter in the expanded configuration thereof to form a second filter basket opening toward the leading end. To prevent longitudinal movement of the filter, the ends of these legs include hooks, at least a portion of which is of a reduced cross sectional area relative to the cross sectional area of the adjacent leg to permit the hooks to bend and straighten in response to withdrawal force.

Claims

1. A blood clot filter having a central longitudinal axis and which is collapsible into a collapsed configuration toward said longitudinal axis for insertion into a blood vessel and which is radially expandable outwardly from said longitudinal axis to an expanded configuration for contact with an inner wall of said blood vessel, said blood clot filter having leading and trailing ends and comprising:

a plurality of elongate, spaced legs which are tubular in configuration and have first and second ends, the first ends of said elongate spaced legs being mounted adjacent to said longitudinal axis and said plurality of elongate spaced legs being formed to extend outwardly away from said longitudinal axis to the second ends thereof which are spaced outwardly from the longitudinal axis in the expanded configuration of said filter,

one or more of said plurality of elongate spaced legs having an outwardly curved hook terminating at a point at the second end thereof to engage and penetrate the vessel inner wall in the expanded configuration of said filter, said curved hook having an elongate shaft which is telescopically received in said elongate leg, the shaft being movable relative to said elongate leg to draw said hook into the elongate leg and straighten the hook, the entire cross sectional area along the length of the hook being of reduced size relative to the cross sectional area of the elongate leg, to permit said hook to bend toward a straightened configuration parallel to said elongate leg in response to force applied to remove said hook from the vessel inner wall, and

an actuator mounted on said filter and connected to said shaft for moving the shaft relative to said elongate leg to draw said hook into the elongate leg.

2. The blood clot filter of claim 1 wherein said actuator means includes an actuator unit connected to each said shaft, said actuator unit being movable along said longitudinal axis away from the second ends of said elongate legs.

3. The blood clot filter of claim 2 wherein said actuator unit includes a drive unit formed of thermal shape memory material oriented to expand from a first collapsed configuration along said longitudinal axis to a second expanded configuration, said thermal shape memory material having a temperature transformation level below which said drive unit is in said first collapsed configuration and above which said drive unit expands along said longitudinal axis to said second expanded configuration.

4. The blood clot filter of claim 2 wherein said elongate spaced legs are formed of thermal shape memory material having a temperature transformation level below which said material is relatively pliable and compressible and above which said material is self-expandable to a substantially rigid, predetermined configuration, the temperature transformation level of the thermal shape memory material of said drive unit being higher than the temperature transformation level of the thermal shape memory material for said elongate legs.

5. A blood clot filter having a central longitudinal axis and which is collapsible into a collapsed configuration toward said longitudinal axis for insertion into a blood vessel and which is radially expandable outwardly from said longitudinal axis to an expanded configuration for contact with an inner wall of said blood vessel, said blood clot filter having leading and trailing ends and comprising:

a plurality of elongate, spaced legs having first and second ends with the first ends of said elongate spaced legs being mounted adjacent to said longitudinal axis and each of said legs being formed to extend outwardly away from said longitudinal axis to the second ends thereof which are spaced outwardly from said longitudinal axis in the expanded configuration of said filter,

one or more of said plurality of elongate spaced legs is tubular in configuration and has an outwardly curved hook terminating at a point at the second end thereof to engage and penetrate the vessel inner wall in the expanded configuration of said filter, said curved hook having an elongate shaft which is telescopically received in said elongate leg, the entire cross sectional area along the length of the hook being of reduced size relative to the cross sectional area of the elongate leg to permit said hook to bend toward a straightened configuration parallel to said elongate leg in response to force applied to remove said hook from the vessel inner wall, and

a plurality of spaced, elongate arms having first and second ends, said first ends of said arms being mounted adjacent to said longitudinal axis, said elongate spaced arms in the expanded configuration of said filter each extending angularly outward away from the longitudinal axis to an elbow spaced between the first and second ends of each said elongate arm and then angularly away from said elbow to the second end of said elongate arm,

said elongate spaced legs extending toward the leading end of said filter to form a first filter basket and each said elongate arm angles outwardly from the longitudinal axis of said filter toward the leading end of said filter and then angles away from the elbow toward the leading end of said filter to form a second filter basket.

6. The blood clot filter of claim 5 wherein said shaft is movable relative to said elongate leg to draw said hook into said elongate leg and straighten said hook.

7. The blood clot filter of claim 6 wherein actuator means are mounted on said filter and connected to said shaft for moving said shaft relative to said elongate leg to draw said hook into said elongate leg.

8. The blood clot filter of claim 7 wherein said actuator means includes an actuator unit connected to each said shaft, said actuator unit being movable along said longitudinal axis away from the second ends of said elongate spaced legs.

9. The blood clot filter of claim 8 wherein said actuator unit includes a drive unit formed of thermal shape memory material oriented to expand from a first collapsed configuration along said longitudinal axis to a second expanded configuration, said thermal shape memory material having a temperature transformation level below which said drive unit is in said first collapsed configuration and above which said drive unit expands along said longitudinal axis to said second expanded configuration.

10. The blood clot filter of claim 9 wherein said elongate spaced legs are formed of thermal shape memory material having a temperature transformation level below which said material is relatively pliable and compressible and above which said material is self-expandable to a substantially rigid, predetermined configuration, the temperature transformation level of the thermal shape memory material of said drive unit being higher than the temperature transformation level of the thermal shape memory material for said elongate spaced legs.

11. A blood clot filter having a central longitudinal axis and which is collapsible into a collapsed configuration toward said longitudinal axis for insertion into a blood vessel and which is radially expandable outwardly from said longitudinal axis to an expanded configuration for contact with an inner wall of said blood vessel, said blood clot filter having leading and trailing ends and comprising:

a plurality of elongate spaced legs having first and second ends, the first ends of said elongate spaced legs being mounted adjacent to said longitudinal axis and said plurality of elongate, spaced legs being formed to extend angularly outwardly away from said longitudinal axis toward the leading end of said filter to second ends of said elongate, spaced legs which are spaced outwardly from said longitudinal axis in the expanded configuration of said filter, and

a plurality of spaced, elongate arms having first and second ends, said first ends of said spaced, elongate arms being mounted adjacent to said longitudinal axis, each of said spaced, elongate arms in the expanded configuration of said filter being formed to extend angularly outwardly away from the longitudinal axis of said filter toward the leading end of said filter to a shoulder spaced between said first and second ends of said elongate arm and then angularly inwardly from said shoulder in the direction of the longitudinal axis of said filter toward the filter leading end to the second end of the said elongate arm.

12. The blood clot filter of claim 11 wherein each of said spaced, elongate arms includes a first arm section which extends from the first end of said arm to said shoulder and a second arm section that extends from said shoulder to the second end of said arm, said first arm section angling outwardly in the expanded configuration of said filter from the first end thereof at a greater angle relative to the longitudinal axis of said filter than the outward angle of said elongate, spaced legs relative to said longitudinal axis of said filter.

13. The blood clot filter of claim 12 wherein the distance between the first and second ends of said elongate, spaced legs is greater than the distance between the first and second ends of said spaced, elongate arms.

14. The blood clot filter of claim 13 wherein said elongate spaced legs are each formed to be substantially straight between the first and second ends thereof and said spaced, elongate arms are each formed to have a substantially straight first arm section between said first end and the shoulder thereof and a substantially straight second arm section between the shoulder and the second end thereof.

15. The blood clot filter of claim 13 wherein said elongate legs extend toward the leading end of said filter to form a first filter basket and each said elongate arm angles outwardly from the longitudinal axis of said filter toward the leading end of said filter and then angles away from said elbow toward the leading end of said filter to form a second filter basket.

16. The blood clot filter of claim 14 wherein each of said elongate spaced legs and the second arm section of each of said spaced elongate arms is formed to engage the inner wall of said blood vessel at an angle within a range of from ten to forty five degrees adjacent to the respective second ends thereof in the expanded configuration of said filter.

17. The blood clot filter of claim 11 wherein one or more of said plurality of elongate spaced legs includes an outwardly curved hook terminating at a point at the second end thereof to engage and penetrate the vessel inner wall in the expanded configuration of said filter, said curved hook being formed with an elasticity sufficient to cause the hook to deform and straighten to permit withdrawal of the hook from the vessel inner wall in response to stress on the hook resulting from force applied to the trailing end of the filter to move the filter in a direction away from the filter leading end.

18. The blood clot filter of claim 17 wherein at least a portion of said hook spaced from said point is formed with a cross sectional area of reduced size relative to the cross sectional area of said elongate leg to permit said hook to bend toward a straightened configuration in response to force applied to the trailing end of said filter.

19. The blood clot filter of claim 17 wherein the elongate spaced legs and each outwardly curved hook included thereon are integrally formed of thermal shape memory material having a temperature transformation level below which the material is in a martensitic state and relatively pliable and compressible and above which the material is normally in an austenitic state and self-expandable to a substantially rigid, predetermined configuration, said material exhibiting stress sensitivity which can cause the material to transform to the martensitic state in response to stress while the temperature of the material remains above the temperature transformation level, each said outwardly curved hook being formed to be transformed from the austenitic state to the martensitic state in response to stress on the hook resulting from force applied to the trailing edge of the filter to move the filter away from the filter leading end while the elongate spaced legs remain in the austenitic state.