MEDICAL DEVICE ANCHOR AND DELIVERY SYSTEM

• US 20100076545A1
• Filed: 11/25/2009
• Published: 03/25/2010
• Est. Priority Date: 11/12/2003
• Status: Active Grant

• Current Assignee: Confluent Medical Technologies, Inc.
• Original Assignee: Nitinol Devices and Components
• Inventors: Ravenscroft, Adrian, Kleshinski, Stephen J.
• Granted Patent: US 8,409,239 B2
• Time in Patent Office: Days
• US Class Current: 623/1.360
• CPC Class Codes: A61B 17/12022 Occluding by internal devices, e.g. balloons or releasable wires plugging an opening in the wall of an organ A61B17/0057; occluders for the cervical canal A61F6/146; vas deferens occluders A61F6/20
• CPC Class Codes: A61B 17/12109 in a blood vessel
• CPC Class Codes: A61B 17/12172 having a pre-set deployed three-dimensional shape methods of manufacturing A61B2017/00526
• CPC Class Codes: A61B 2017/12054 Details concerning the detachment of the occluding device from the introduction device
• CPC Class Codes: A61B 2017/12095 Threaded connection
• CPC Class Codes: A61F 2/0105 Open ended, i.e. legs gathered only at one side
• CPC Class Codes: A61F 2002/016 made from wire-like elements
• CPC Class Codes: A61F 2230/005 Rosette-shaped, e.g. star-shaped
• CPC Class Codes: A61F 2230/0078 hyperboloidal

Abstract

A method and apparatus for anchoring a medical implant device after the device has been brought to rest at a desired position within a blood vessel or other body passageway. An anchor delivery system is provided which houses one or more uniquely configured expandable anchors which are connected to the medical implant device. The anchors remain housed in a non expanded configuration until after the medical implant device has come to rest in a desired position within the body, and then the anchors are positively propelled through a body wall from a first side to a second side where each anchor expands outwardly from an anchor shaft. In one configuration, the anchors are each formed in the shape of a compressible closed loop which extends outwardly from an anchor shaft and loops back to cross over and extend beyond the anchor shaft. To positively propel the anchors, a drive shaft for the anchor shafts extends back to a triggering unit which, when activated, causes the drive shaft to drive the anchor shafts in a direction which results in propulsion of the anchors through the body wall.

Claims

1. A medical device anchor for penetration through a body wall from a first side to a second side thereof and expansion against said second side comprising:

an anchor shaft having a proximal end and a distal end,

an expandable anchor at the distal end of said anchor shaft having one or more anchor sections, said expandable anchor having a first collapsed configuration wherein said anchor is substantially coextensive with said anchor shaft and a second expanded configuration wherein said one or more anchor sections extend arcuately outwardly from said anchor shaft and loop back to cross and extend beyond said anchor shaft to form a closed loop.

2. The medical device anchor of claim 1 wherein said expandable anchor includes a pointed lead end.

3. The medical device anchor of claim 1 wherein said one or more anchor sections are configured to extend outwardly from said anchor shaft and loop back to cross over said anchor shaft in the second expanded configuration of said expandable anchor.

4. The medical device anchor of claim 1 wherein said one or more anchor sections are configured to extend outwardly from said anchor shaft and loop back to cross under said anchor shaft in the second expanded configuration of said expandable anchor.

5. The medical device anchor of claim 3 wherein said one or more anchor sections compress against said body wall and change configuration to form a smaller closed loop in response to forces which draw said one or more anchor sections against said body wall in the second expanded configuration of said expandable anchor.

6. The medical device anchor of claim 2 wherein said expandable anchor is formed of shape memory material which is compliable and compressible in a first state and which is self-expandable in a second state to a substantially rigid, predetermined spiral configuration.

7. The medical device anchor of claim 1 wherein the proximal end of said anchor shaft is connected to a shaft support hub, said shaft support hub having a connector for receiving a drive shaft.

8. A medical device anchor and delivery system for propelling an anchor through a body wall from a first side to a second side where said anchor expands against said second side comprising:

an anchor shaft having a proximal end and a distal end,

an expandable anchor at the distal end of said anchor shaft having one or more anchor sections, said expandable anchor having a first collapsed configuration wherein said anchor is substantially coextensive with said anchor shaft and a second expanded configuration wherein said one or more anchor sections extend arcuately outwardly from said anchor shaft and loop back to cross and extend beyond said anchor shaft to form one or more closed loops,

a shaft support hub connected to the proximal end of said anchor shaft,

an elongate tube having an entry end and an exit end, said tube containing said anchor shaft with said expandable anchor in said collapsed configuration adjacent to said exit end, and

a drive shaft having a first end in engagement with said shaft support hub and operative when propelled to cause said shaft support hub to move said anchor shaft longitudinally of said elongate tube to propel said expandable anchor outwardly from the exit end of said tube.

9. The medical device anchor and delivery system of claim 8 wherein said drive shaft includes a second end opposite to said first end, said second end being connected to a propulsion unit operative to propel said drive shaft.

10. The medical device anchor and delivery system of claim 9 wherein the entry end of said elongate tube is connected to a tube retention sleeve, said anchor shaft extending outwardly from the entry end of said elongate tube to said shaft support hub spaced from said tube retention sleeve when said expandable anchor is in said collapsed configuration within said elongate tube, said drive shaft operating when propelled to move said shaft support hub toward said tube retention sleeve.

11. The medical device anchor and delivery system of claim 10 wherein said expandable anchor includes a pointed lead end.

12. The medical device anchor and delivery system of claim 11 wherein said one or more anchor sections curve outwardly from said anchor shaft and back to cross over said anchor shaft in the second expanded configuration of said expandable anchor.

13. The medical device anchor and delivery system of claim 11 wherein said one or more anchor sections curve outwardly from the anchor shaft and back to cross under said anchor shaft in the second expanded configuration of said expandable anchor.

14. The medical device anchor and delivery system of claim 11 wherein said expandable anchor is formed of thermal shape memory material having a temperature transformation level where at temperatures below said temperature transformation level said shape memory material is relatively pliable and compressible and at temperatures at least at or above said temperature transformation level said shape memory material is self-expandable to a substantially rigid predetermined configuration.

15. A blood clot filter with an anchor delivery system for propelling one or more anchors through the wall of a blood vessel from a first inner side to a second outer side, the blood clot filter having a central longitudinal axis and being collapsible to a collapsed configuration toward said longitudinal axis and expandable in an expanded configuration outwardly from said longitudinal axis for contact with said inner side of the wall of said blood vessel, said blood clot filter with anchor delivery system comprising:

a plurality of elongate, spaced legs each having a distal end and a proximal end, the proximal ends of said elongate legs being secured together adjacent to the longitudinal axis of said blood clot filter, said plurality of elongate spaced legs being formed to extend outwardly away from said longitudinal axis to bring the distal ends thereof into contact with the first inner side of a blood vessel in the expanded configuration of said blood clot filter, one or more of said elongate spaced legs being tubular in configuration with an open distal and an open proximal end,

an elongate anchor shaft mounted for longitudinal movement in each of said tubular elongate legs, each said elongate anchor shaft having first and second opposed ends,

an expandable anchor at the second end of each of said anchor shafts, said expandable anchor having one or more anchor sections with a first collapsed configuration wherein said anchor is substantially coextensive with said anchor shaft and a second expanded configuration wherein said one or more anchor sections extend outwardly from said anchor shaft and loop back to cross and extend beyond said anchor shaft to form one or more closed loops,

said tubular elongate legs each containing said expandable anchor in the first collapsed condition adjacent to the open distal end thereof, and

a shaft support hub connected to the first end of each elongate anchor shaft, said shaft support hub being spaced from the proximal ends of said elongate legs when an expandable anchor in the first collapsed condition is contained in said tubular elongate legs, said shaft support hub being movable toward said proximal ends of said elongate legs to move said anchor shafts longitudinally to propel said expandable anchors out from the open distal ends of said tubular elongate legs and through the wall of a blood vessel.

16. The blood clot filter with anchor delivery system of claim 15 wherein each said expandable anchor includes one or more anchor sections which expand outwardly from said anchor shaft and loop back to cross over said anchor shaft when said expandable anchor is propelled out from the open distal end of a tubular elongate leg and through the wall of a blood vessel, said expandable anchor being oriented such that that the loop formed by each of said one or more anchor sections compresses against said blood vessel wall and changes configuration to form a smaller loop in response to forces which draw said loop against said blood vessel wall.

17. The blood clot filter with anchor delivery system of claim 15 wherein each said expandable anchor includes one or more anchor sections which expand outwardly from said anchor shaft and loop back to cross under said anchor shaft when said expandable anchor is propelled out from the open distal end of a tubular elongate leg and through the wall of a blood vessel.

18. The blood clot filter with anchor delivery system of claim 15 which includes a drive shaft having a first drive shaft end connected to said shaft support hub to move said shaft support hub relative to the proximal ends of said elongate legs.

19. The blood clot filter with anchor delivery system of claim 18 wherein said drive shaft is mounted for movement within an elongate filter centering shaft having an inner end spaced adjacent to said shaft support hub, said filter centering shaft having a plurality of elongate, spaced, centering arms secured at one end to said centering shaft inner end, said centering arms being adapted to expand outwardly into engagement with said blood vessel wall inner side.

20. The blood clot filter with anchor delivery system of claim 19 wherein said drive shaft includes a second drive shaft end opposite to said first drive shaft end, said second drive shaft end being connected to a propulsion device to cause said drive shaft to propel said shaft support hub toward the proximal ends of said elongate legs.