Steerable drug delivery device

• US 6,623,448 B2
• Filed: 03/30/2001
• Issued: 09/23/2003
• Est. Priority Date: 03/30/2001
• Status: Expired due to Term

• Current Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Original Assignee: Advanced Cardiovascular Systems Incorporated (Abbott Laboratories)
• Inventors: Slater, Renee C.
• Primary Examiner(s): EVANS, ROBIN OCTAVIA
• Application Number:
  US09/822,081
• Publication Number:
  US 20020143291A1
• Time in Patent Office: 907 Days
• Field of Search: 604/95.02, 604/104, 604/105, 604/106, 604/107, 604/280, 604/281, 604/95.01, 606/198
• US Class Current: 604/95.01
• CPC Class Codes: A61M 2025/0089 Single injection needle protruding axially, i.e. along the longitudinal axis of the catheter, from the distal tip
• CPC Class Codes: A61M 2025/1079 having radio-opaque markers in the region of the balloon
• CPC Class Codes: A61M 2210/125 Heart
• CPC Class Codes: A61M 25/0084 being one or more injection needles
• CPC Class Codes: A61M 25/0138 having flexible regions as a result of weakened outer material, e.g. slots, slits, cuts, joints or coils
• CPC Class Codes: A61M 25/0147 with movable mechanical means, e.g. pull wires
• CPC Class Codes: A61M 25/04 in the body, e.g. expansible A61M25/10, A61M16/0488 take precedence

Abstract

A medical apparatus used to deliver a therapeutic substance. The medical apparatus provides a catheter assembly, which includes a translating body assembly and a fixed body assembly mated together in a telescopic configuration to allow the translating body assembly to move relative to the fixed body assembly and facilitate the delivery of the therapeutic substance to a targeted area. The catheter assembly also provides a steering assembly capable of moving the distal portion of the catheter assembly between a first direction and a second direction. A guiding catheter including an anchoring device can be used to secure the catheter assembly in position at the targeted area to facilitate deployment of a needle for delivering the therapeutic substance to the targeted area.

Claims

1. A medical implement comprising:

an outer member having a proximal end, a distal end, and a lumen extending therethrough;

an inner member having a proximal portion, a distal portion and a needle coupled to said distal portion, said inner member being slidably disposed in said outer member lumen, and said inner member having a plurality of indentations for increasing the flexibility of said distal portion of said inner member; and

a steering assembly coupled to said inner member for steering said needle to a target location.

2. The medical implement of claim 1, wherein said outer member comprises a polymer sheath.

3. The medical implement of claim 1, further comprising an anchoring device for holding said needle in contact with said target location.

4. The medical implement of claim 1, wherein said inner member comprises a hypotube having a lumen extending therethrough.

5. The medical implement of claim 1, wherein said inner member comprises a coiled member including a first coil layer and a second coil layer, said first coil layer being more tightly wound than said second coil layer to increase the flexibility of said inner member.

6. The medical implement of claim 1, wherein said steering assembly comprises a first steering tendon, and a second steering tendon, wherein each of said first and second steering tendons can cause said distal portion of said inner member to flexibly bend.

7. The medical implement of claim 6, wherein said first steering tendon is coupled to a first puller and said second steering tendon is coupled a second puller, said pullers are configured to apply a tension to said steering tendons.

8. The medical implement of claim 1, wherein said inner member is capable of being moved relative to said outer member between a first position, where said needle is in a retracted position and a second position, where said needle is in an extended position.

9. The medical implement of claim 7, wherein said first and second pullers are ring-shaped and rotatably disposed around said proximal portion of said inner member such that rotation of each puller in a first direction around said proximal portion of said inner member increases the tension applied to the respective steering tendon and rotation in a second direction around said proximal portion of said inner member opposite the first direction decreases the tension applied to the respective steering tendon.

10. The medical implement of claim 9, wherein said first and second pullers have an annular groove therearound, and wherein each of said steering tendons has a portion disposed in said annular groove of said associated puller.

11. A medical implement comprising:

a translating body assembly having a substantially flexible distal portion;

a fixed body assembly configured to be mated with said translating body assembly, said translating body assembly being moveable relative to said fixed body assembly;

a first steering tendon coupled to said distal portion of said translating body assembly to move said distal portion in a first direction; and

a second steering tendon coupled to said distal portion of said translating body assembly to move said distal portion in a second direction, wherein said first steering tendon is operably engaged with a first puller assembly via a first biasing element and said second steering tendon is operably engaged with a second puller assembly via a second biasing element.

12. The implement of claim 11, wherein said translating body assembly comprises an outer member and an inner member slidably disposed in said outer member, wherein said inner member includes modification to provide said substantially flexible distal portion.

13. The implement of claim 12, wherein said inner member comprises a hollow hypotube.

14. The implement of claim 11, wherein said translating body assembly comprises a needle extending out from said distal portion for delivering a therapeutic substance.

15. The implement of claim 11, wherein said relative movement between said translating body assembly and said fixed body assembly causes an injection port coupled at a distal end of said translating body assembly to move between a first position where said injection port is provided inboard of said translating body assembly and a second position where said injection port is outboard of said translating body assembly.

16. The implement of claim 15, further comprising an anchoring device for holding said injection port in contact with a target location within the human body.

17. A medical device, comprising:

an elongated member for inserting in a body lumen;

a steering tendon coupled at one end to a distal portion of said elongated member to flex said distal portion of said elongated member; and

a pulling assembly coupled to the other end of said steering tendon for applying tension to said steering tendon, said steering tendon being coupled to said pulling assembly by a biasing element.

18. The device of claim 17, wherein the biasing element is a spring.

19. The device of claim 17, additionally comprising a needle in fluid communication with said elongated member for deliver of a therapeutic substance.

20. A medical implement for delivering a therapeutic substance to a target area within the human body comprising:

a catheter body having a proximal end, a distal end, and a lumen extending there between;

an intraventricular device moveable relative to said catheter body, said intraventricular device including a plurality of indentations for increasing the flexibility of a distal portion of said intraventricular device;

a injection element in fluid communication with said intraventricular device for delivering a therapeutic substance; and

an anchoring device positioned proximate to said distal end of said catheter body, said anchoring device configured to maintain said intraventricular device in a stationary position during delivery of said therapeutic substance.

21. The medical implement of claim 20, wherein said anchoring device comprises a plurality inflatable sections spaced apart along a longitudinal axis of said catheter body, each inflatable section capable of being inflated independent of the other inflatable sections.

22. The medical implement of claim 20, wherein said catheter body comprises an inner catheter lumen telescopically disposed in an outer catheter lumen, said inner and outer catheter lumens being coupled at a distal end of said inner and outer catheter lumens, and wherein said anchoring device is defined by a plurality of struts extending axially around the circumference of said outer catheter lumen such that the telescopic movement of the outer catheter lumen over said inner catheter lumen toward said distal end causes said struts to expand in an outwardly bowed configuration for compressing said struts against an inner wall of a bodily lumen.

23. The medical implement of claim 21, wherein at least one of said inflatable sections has a tapered outer end that tapers at an angle between about 15 degrees and less than about 90 degrees when said inflatable section is inflated to an expanded configuration.

24. The medical implement of claim 20, wherein said catheter body comprises:

a first tube; and

a second tube disposed within said first tube, said first tube including struts that define said anchoring device, said struts configured to expand in an outwardly direction in response to relative movement between said first tube and said second tube.

25. The medical implement of claim 20, wherein said anchoring device comprises a balloon intergraded with said catheter body.

26. A medical implement for delivering a therapeutic substance to a target area within the human body comprising:

an outer member having a proximal end, a distal end, and a lumen extending therethrough;

an inner member having a proximal portion and a distal portion, said distal portion of said inner member having a plurality of indentations for increasing the flexibility of said distal portion; and

a needle in fluid communication-with said inner member, said inner member slidably disposed in said outer member between a first position, where said needle is inboard of said outer member lumen, and a second position, where said needle is outboard of said outer member lumen; and

a steering assembly coupled to said distal portion of said inner member for moving said needle between a first direction and a second direction.

27. A method for delivering a therapeutic substance to a target area within the human body comprising:

delivering a medical implement to a target location within the human vasculature, said medical implement having an outer member, an inner member disposed in said outer member and a needle in fluid communication with said inner member, said inner member having a distal portion adjacent to said needle, said distal portion of said inner member having a plurality of indentations for increasing the flexibility of said distal portion of said inner member;

moving said inner member relative to said outer member between a first position, where said needle is within said outer member and a second position, where said needle is outside of said outer member;

applying a first tension to a first tendon to cause said needle to move in a first direction and/or applying a second tension to a second tendon to cause said needle to move in a second direction; and

causing said needle to penetrate into said target location; and

delivering said therapeutic substance to said target location.

28. The method of claim 27, wherein said first tension is applied to said first tendon by rotating a first puller coupled to an end of said first tendon via a first biasing element and wherein said second tension is applied to said second tendon by rotating a second puller coupled to an end of said second tendon via a second biasing element.

29. A medical implement comprising:

an outer member having a proximal end, a distal end, and a lumen extending therethrough;

an inner member having a proximal portion, a distal portion and a needle coupled to said distal portion, said inner member being slidably disposed in said outer member lumen;

a steering assembly coupled to said inner member for steering said needle to a target location; and

wherein said inner member comprises a pattern of indentations formed on said distal portion for increasing the flexibility of said inner member.

30. A medical implement comprising:

a translating body assembly having a substantially flexible distal portion;

a fixed body assembly configured.to be mated with said translating body assembly, said translating body assembly,being moveable relative to said fixed body assembly;

a first steering tendon coupled to said distal portion of said translating body assembly to move said distal portion in a first direction;

a second steering tendon coupled to said distal portion of said translating body assembly to move said distal portion in a second direction;

wherein said translating body assembly comprises an inner member having modification to provide said substantially flexible distal portion;

wherein said inner member comprises a hollow hypotube; and

wherein said modification of said hypotube comprises indentations formed into said hypotube along said substantially flexible distal portion.

31. A medical implement comprising:

a translating body assembly having a substantially flexible distal portion;

a fixed body assembly configured to be mated with said translating body assembly, said translating body assembly being moveable relative to said fixed body assembly;

a first steering tendon coupled to said distal portion of said translating body assembly to move said distal portion in a first direction;

a second steering tendon coupled to said distal portion of said translating body assembly to move said distal portion in a second direction;

wherein said translating body assembly comprises an inner member having modification to provide said substantially flexible distal portion;

wherein said inner member comprises a hollow hypotube; and

wherein said modification of said;

hypotube comprises indentations formed into said hypotube, wherein said indentations are variably spaced along said substantially flexible distal portion.

32. A medical device, comprising:

an elongated member for inserting in a body lumen, said elongated member comprising a segment having grooves for increasing the flexibility of said segment of said elongated member;

a steering tendon coupled at one end to said elongated member for flexing said segment of said elongated member; and

a pulling assembly coupled to the other end of said steering tendon for applying tension to said steering tendon.

33. The device of claim 32, additionally comprising a needle in fluid communication with said elongated member for deliver of a therapeutic substance.