Removable embolus blood clot filter and filter delivery unit

• US 6,258,026 B1
• Filed: 07/26/1999
• Issued: 07/10/2001
• 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): Recla, Henry J.
• Assistant Examiner(s): NGO, LIEN M
• Application Number:
  US09/360,654
• Time in Patent Office: 715 Days
• Field of Search: 606/200, 606/198, 606/194, 606/191, 606/127, 606/113
• US Class Current: 600/200
• 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 removable blood clot filter having leading and trailing ends and a filter central longitudinal axis and which is collapsible in a collapsed configuration toward said filter longitudinal axis for insertion into a blood vessel and is radially expandable outwardly from said filter longitudinal axis to an expanded configuration to contact and penetrate an inner wall of said blood vessel to provide a filter migration resistance force sufficient to prevent filter migration in response to blood pressure within said blood vessel comprising:

a plurality of elongate, spaced appendages having first and second ends, the first ends of said plurality of elongate spaced appendages being formed to extend outwardly toward said filter leading end away from said filter longitudinal axis in the expanded configuration of said filter, each of a plurality of said elongate spaced appendages having an appendage longitudinal axis and a pointed hook formed at the second end thereof which extends laterally outward relative to said appendage longitudinal axis in a direction away from said filter longitudinal axis to engage and penetrate the vessel inner wall in the expanded configuration of said filter, each said hook being formed with a maximum migration force such that a force above said maximum migration force applied to said hook as a result of a withdrawal force in excess of said filter migration resistance force applied to the trailing end of said filter in a direction away from the filter leading end will cause said hook to straighten and bend toward the filter longitudinal axis and toward a configuration parallel with the appendage longitudinal axis, to facilitate removal of the hook from the vessel wall without tearing the vessel wall, the sum of the maximum migration forces for the hooks for said filter being substantially equal to the filter migration resistance force.

2. The removable blood clot filter of claim 1 wherein each said hook curves laterally relative to said appendage longitudinal axis and outwardly away from said filter longitudinal axis to a pointed end.

3. The removable blood clot filter of claim 2 wherein at least a portion of said hook is formed with a cross sectional area of reduced size relative to the cross sectional area of said appendage to provide the maximum migration force above which the hook will bend toward a straightened configuration.

4. The removable blood clot filter of claim 1 wherein said hooks are formed to impart a filter migration resistance force to said filter within a range of from 10 mmHg to 120 mmHg.

5. The removable blood clot filter of claim 1 wherein said elongate appendages include a plurality of spaced elongate substantially straight legs and a plurality of spaced, elongate arms, both said elongate legs and arms having first ends mounted adjacent to said longitudinal axis, said arms in the expanded configuration of said filter each extending in a substantially straight line angularly outward away from the longitudinal axis to an elbow spaced between said first and second ends of said arm and then angularly away from said elbow in a substantially straight line to the second end of said arm.

6. The removable blood clot filter of claim 5 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.

7. The removable blood clot filter of claim 4 wherein said hooks are formed to impart a filter migration resistance force to said filter of substantially 50 mmHg.

8. The removable blood clot filter of claim 5 wherein said hooks are formed to impart a filter migration resistance force to said filter within a range of from 10 mmHg to 120 mmHg.

9. The removable blood clot filter of claim 5 wherein said hook curves laterally relative to said appendage longitudinal axis and outwardly from said filter longitudinal axis to a pointed end.

10. The removable blood clot filter of claim 9 wherein at least a portion of said hook is formed with a cross sectional area of reduced size relative to the cross sectional area of said appendage to provide the maximum migration force above which the hook will bend toward a straightened configuration.

11. The removable blood clot filter of claim 3 wherein the entire cross sectional area along the length of each said hook is of reduced size relative to the cross sectional area of the appendage bearing said hook.

12. The removable blood clot filter of claim 3 wherein said elongate appendages and hooks 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, and wherein withdrawal force applied to the trailing end of said filter results in stress being concentrated in the reduced cross sectional area of said hooks.

13. The removable blood clot filter of claim 10 wherein the entire cross sectional area along the length of said hook is of reduced size relative to the cross sectional area of the appendage bearing the hook.

14. The removable blood clot filter of claim 10 wherein each said hook is formed integrally with the second end of an elongate leg, said hook being formed with a joinder section adjacent to said elongate leg, said joinder section having a cross sectional area which is reduced in size relative to the cross sectional area of said elongate leg.

15. The removable blood clot filter of claim 10 wherein said elongate, legs and hooks 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, and wherein withdrawal force applied to the trailing end of said filter results in stress being concentrated in the reduced cross sectional area of said hooks.