Expansile device for use in blood vessels and tracts in the body and tension application device for use therewith and method

• US 5,922,009 A
• Filed: 11/18/1997
• Issued: 07/13/1999
• Est. Priority Date: 02/11/1997
• Status: Expired due to Term

• Current Assignee: Cardiva Medical, Inc. (Haemonetics Corporation)
• Original Assignee: Biointerventional Corporation
• Inventors: Martin, Brian B., Epstein, Gordon H., Lempert, Todd E.
• Primary Examiner(s): Buiz, Michael
• Assistant Examiner(s): TRINH, HOA B
• Application Number:
  US08/972,383
• Time in Patent Office: 602 Days
• Field of Search: 606/213, 606/215, 606/216, 606/151, 606/195, 606/108, 623/1, 623/11, 623/12, 128/899
• US Class Current: 606/213
• CPC Class Codes: A61B 17/00491 Surgical glue applicators surgical adhesives A61L24/00; two-component delivery syringes A61M5/19
• CPC Class Codes: A61B 17/0057 Implements for plugging an opening in the wall of a hollow or tubular organ, e.g. for sealing a vessel puncture or closing a cardiac septal defect sutures A61B17/04; closing rectum or urethra near body surface A61F2/0009
• 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 2017/00495 for two-component glue
• CPC Class Codes: A61B 2017/00637 for sealing trocar wounds through abdominal wall
• CPC Class Codes: A61B 2017/00641 for closing fistulae, e.g. anorectal fistulae
• CPC Class Codes: A61B 2017/00659 located only on one side of the opening
• CPC Class Codes: A61B 2017/00867 shape memory effect for prostheses A61F2210/0014

Abstract

A device for expansion within a blood vessel having a wall defining a lumen in the body. The device comprises a first elongate tubular member having proximal and distal extremities and having a longitudinal axis. An expansile member is carried by the distal extremity of the first elongate tubular member and is movable between contracted and expanded positions. The expansile member has a predetermined configuration in the expanded position. A deformable membrane covers the expansile member and is sized so as to be capable of overlying and underlying the expansile member in the expanded position. Deployment means are carried by the proximal extremity of the first elongate tubular member and are adapted to be operated by the human hand for controlling movement of the expansile member between the contracted and expanded positions.

Claims

1. A device for expansion within a blood vessel having a wall defining a lumen in the body comprising a first elongated tubular member having proximal and distal extremities and having a longitudinal axis, an expansile member carried by the distal extremity of the first elongated tubular member and movable between contracted and expanded configurations, said expansile member in the expanded configuration having distal and proximal surfaces, a deformable membrane carried by the first elongated tubular member, said deformable membrane being formed so as to be capable of expanding to have a first layer overlying the distal surface of the expansile member in the expanded configuration and a second layer underlying the proximal surface of the expansile member in the expanded configuration and deployment means carried by the proximal extremity of the first elongated tubular member and coupled to the expansile member, said deployment means being adapted to be operated by the human hand for controlling movement of the expansile member between the contracted configuration permitting introduction into a lumen of a blood vessel and the expanded configuration within the lumen of the blood vessel, and thereafter to the contracted configuration permitting removal from the blood vessel.

2. The device as in claim 1 wherein said membrane is sized so as to be capable of expanding relative to the expansile member and constraining the expansile member into said expanded configuration.

3. A device as in claim 1 further including tensioning means for maintaining engagement of said expansile member in the expanded position with the wall in the lumen of the blood vessel.

4. The device as in claim 3 wherein said tensioning means includes a base portion, an arm connected to said base portion and movable between open and closed positions with respect to said base portion, said arm having means for grasping said first elongated tubular member and means for biasing said top portion into the open position.

5. The device as in claim 4 wherein said means for grasping said first elongated tubular member includes at least one grasping member carried by said arm, said grasping member being movable between open and closed positions.

6. The device as in claim 5 wherein said grasping member is formed so as to be biased into said closed position for grasping said first elongated tubular member.

7. The device as in claim 4 further including a first slot in the fixture and a second slot in the arm which is aligned with the first slot when the arm is in the closed position, said first elongated tubular member being disposed in said first and second slots when grasped by said grasping means.

8. A device as in claim 4 wherein said means for biasing said arm into the open position includes a spring capable of producing a substantially constant force of tension over a range of motion.

9. A device as in claim 8 wherein said spring is a coil spring.

10. The device as in claim 1 wherein said expansile member is comprised essentially of a superelastic material having a free state and having a configuration in the free state which is a substantially complex geometrical configuration selected from a group consisting of a substantially flat coil, a helical coil, a plurality of struts and a flower.

11. The device as in claim 10 wherein said configuration in the free state has a larger size than said expanded configuration of said expansile member covered by said membrane.

12. The device as in claim 11 wherein said membrane is formed to permit movement of the expansile member within the membrane and to constrain said expansile member from the free state configuration into said smaller expanded configuration during movement between contracted and expanded configurations.

13. The device as in claim 10 wherein said configuration in a free state is substantially non-planar and said expanded configuration is substantially planar.

14. The device as in claim 10 wherein said configuration in a free state is a bi-conical coil-like configuration.

15. The device as in claim 14 wherein said coil-like configuration includes proximal, middle and distal turns which are non-planar with respect to one another, said proximal and distal turns being of substantially equal size and said middle turn being larger than said proximal and distal turns.

16. The device as in claim 1 wherein the membrane has a closed end and an open end circumscribed by a rim and means for securing the rim to the distal extremity of the first elongated tubular member, said membrane being formed to permit movement of the expansile member within the membrane during movement between contracted and expanded configurations and to constrain said expansile member into its expanded configuration.

17. The device as in claim 1 further including means coupled to said first elongated tubular member for introducing a biological sealant into the body proximal to said expansile member and external to the lumen of the vessel, said introducing means including a second elongated tubular member having proximal and distal extremities and having a longitudinal axis, said second elongated tubular member having an inner wall defining a lumen extending from the proximal to the distal extremity of said second elongated tubular member, said lumen of the second elongated tubular member having a diameter greater than the outer diameter of said first elongated tubular member, said first elongated tubular member being disposed within the lumen of said second elongated tubular member thereby defining a space between said first elongated tubular member and the inner wall of said second elongated tubular member, the distal extremity of said second elongated tubular member terminating proximal to the distal extremity of said first elongated tubular member and adjacent to said expansile member.

18. A device as in claim 17 wherein said biological sealant is selected from a group consisting of:

(a) fibrin glue;

(b) collagen;

(c) Avitene;

(d) cellulose;

(e) gelatin;

(f) Gelfoam;

(g) thrombin;

(h) fibrin;

(i) thrombin-collagen.

19. The device as in claim 17 wherein said second elongated tubular member includes a second lumen extending from the proximal extremity to the distal extremity of the second elongated tubular member.

20. The device as in claim 19 wherein said second elongated tubular member includes a third lumen extending from the proximal extremity to the distal extremity of said second elongated tubular member.

21. The device as in claim 19 further comprising a third elongated member having proximal and distal extremities and a longitudinal axis, said third elongated member being sized to be disposed within the second lumen of said second elongated member.

22. The device as in claim 20 wherein the distal extremity of the second elongated tubular member carries a mixing chamber which is contiguous with the second and third lumens of the second elongated tubular member.

23. The device as in claim 21 wherein said third elongated member has a length substantially equal to the length of said second elongated member.

24. The device as in claim 21 wherein said third elongated member has a lumen extending from the proximal to the distal extremity of the third elongated member and wherein the distal extremity of said third elongated member terminates prior to the distal extremity of said second elongated member.

25. The device as in claim 24 wherein the second lumen of the second elongated tubular member is semi-circular in shape and the third elongated member is tubular in shape.

26. The device as in claim 24 wherein said third elongated member has a second lumen extending from the proximal to the distal extremity of the third elongated member.

27. The device as in claim 26 wherein the distal extremity of the third elongated member carries a mixing chamber which is contiguous with the first and second lumens of the third elongated member.

28. The device as in claim 1 wherein said deployment means includes a push-pull member.

29. The device as in claim 28 wherein said push-pull member is a wire.

50. The device as in claim 10 wherein said configuration in the free state has a substantially different configuration than said expanded configuration of said expansile member covered by said membrane.

30. A device for being expanded within a blood vessel having a wall defining a lumen in the body comprising an elongated tubular body having proximal and distal extremities and having a longitudinal axis, said elongated tubular body further comprising first, second and third elongated tubular members, each of said tubular members having proximal and distal extremities and a longitudinal axis and having a lumen defining an inner wall and extending from the proximal to the distal extremity of each of said tubular members, the first elongated tubular member having a diameter being sized so that it can be disposed within the lumen of the second elongated tubular member thereby defining a first space between the first and second elongated tubular members, the second elongated tubular member having a diameter being sized so that it can be disposed within the lumen of the third elongated tubular member thereby defining a second space between the second and third elongated tubular members, an expansile member carried by the distal end of said elongated tubular body and movable between contracted and expanded configurations, a deformable membrane carried by said elongated tubular body, said deformable membrane being sized so as to be capable of expanding to have a first layer underlying and a second layer overlying the expansile member in the expanded configuration and deployment means carried by the proximal extremity of the elongated tubular body and adapted to be operated by the human hand for controlling movement of the expansile member between the contracted and expanded configurations.

31. The device as in claim 30 wherein said membrane is sized so as to be capable of expanding relative to the expansile member and constraining the expansile member into said expanded configuration.

32. The device as in claim 30 further including means for disengaging and removing said second elongated tubular member.

33. The device as in claim 32 further including means for disengaging and removing said third elongated tubular member.

34. The device as in claim 30 further including means carried by said elongated tubular body for introducing at least one biological sealant into the proximal extremity of said elongated tubular body into said first and second spaces so that said sealant is introduced into the body proximal to said expansile member and external to said vessel lumen.

35. The device as in claim 34 wherein the distal extremity of said third elongated tubular member terminates distal to the distal extremity of said second elongated tubular member and proximal to the distal extremity of said first elongated tubular member thereby defining a distal mixing chamber between said first elongated tubular member and the inner wall of said third elongated tubular member.

36. The device as in claim 30 further including tensioning means for maintaining engagement of said expansile member in the expanded configuration with the wall in the lumen of the blood vessel.

37. The device as in claim 30 wherein said expansile member is comprised essentially of a superelastic material having a free state and having a configuration in the free state which is a substantially complex geometrical configuration selected from the group consisting of a substantially flat coil, a helical coil, a plurality of struts and a flower.

38. The device as in claim 37 wherein said configuration in the free state is a bi-conical coil-like configuration.

39. The device as in claim 30 wherein the membrane has a closed end and an open end circumscribed by a rim and means for securing the rim to the distal extremity of the first elongated tubular member, said membrane being formed to permit movement of the expansile member within the membrane during movement between contracted and expanded configurations and to constrain said expansile member into its expanded configuration.

40. A device for applying tension on a catheter extending into a puncture in the wall of the blood vessel underlying the skin of a patient, the catheter having proximal and distal extremities and an expansile assembly secured to the distal extremity comprising a fixture having a base adapted to rest on the skin of the patient, a movable arm pivotally mounted on the base and means mounted on the arm for releasably grasping the proximal extremity of the catheter and means carried by the base and engaging the arm to yieldably urge the arm in a direction away from the skin of the patient whereby a tensioning force is applied to the catheter to attempt to withdraw the catheter from the puncture so that the expansile assembly is retained in engagement with the wall of the vessel at the puncture.

41. The device as in claim 40 wherein the means mounted on the arm releasably grasping the proximal end of the catheter includes first and second grasping members and first and second spring members carrying said grasping members mounted on said arm and urging the grasping members toward a catheter grasping position and means mounted on the arm engagable by the hand for overcoming the yieldable force of the first and second spring members to move the grasping members to a catheter release position.

42. The device as in claim 41 wherein said grasping members have serrated surfaces for engaging the catheter.

43. The device as in claim 40 wherein said means carried by the base for yieldably urging the arm in a direction away from the skin of the patient includes a spring.

44. The device as in claim 43 wherein said spring is a constant force spring.

45. A method for percutaneously expanding a device within a blood vessel having a wall defining a lumen in the human body, by use of a device having a first elongated tubular member having proximal and distal extremities and a longitudinal axis, an expansile member carried by the distal extremity of the first elongated tubular member, a deformable membrane carried by said first elongated tubular member, said expansile member being movable between contracted and expanded configurations and said membrane being formed so as to be capable of expanding to have a first layer underlying and a second layer overlying the expansile member in the expanded configuration and deployment means carried by the proximal extremity of the of the first elongated member and adapted to be operated by the human hand for controlling movement of the expansile member between contracted and expanded configurations, the method comprising introducing the distal extremity of the first elongate tubular member and the expansile member carried thereby through the wall of the vessel so that the expansile member is disposed within the lumen of the vessel, moving the expansile assembly from a contracted to an expanded configuration and pulling the first elongated tubular member proximally to bring the expansile member into engagement with the wall in the lumen of the vessel.

46. The method as in claim 45 together with the step of applying a predetermined proximal force of tension to the expansile member after bringing the expansile member into engagement with the wall of the lumen of the vessel and releasing said tension before moving the expansile member from the expanded configuration to the contracted configuration.

47. A method for percutaneously expanding a device in a blood vessel having a wall defining a lumen in the human body by use of a device having a elongated tubular body having proximal and distal extremities and having a longitudinal axis, said elongated tubular body having a first elongated tubular member having proximal and distal extremities and having a longitudinal axis, said first elongated tubular member having a lumen extending from the proximal to the distal extremity, a second elongated tubular member having proximal and distal extremities and having a longitudinal axis and having an inner wall defining a lumen extending from the proximal extremity to the distal extremity of the second elongated tubular member, said first elongated tubular member being nested within the lumen of the second elongated tubular member thereby defining a first space between the first elongated tubular member and the inner wall of said second elongated tubular member, a third elongated tubular member having proximal and distal extremities and having a longitudinal axis and having an inner wall defining a lumen extending from the proximal to the distal extremity of said third elongated tubular member, said second elongated tubular member being nested within the lumen of the third elongated tubular member thereby defining a second space between the second elongated tubular member and the inner wall of said third elongated tubular member, an expansile member carried by the distal end of said elongated tubular body and movable between contracted and expanded configurations, a deformable membrane carried by the first elongated tubular member, said membrane being sized so as to be capable of overlying and underlying the expansile member in the expanded configuration and deployment means carried by the proximal extremity of the elongated tubular body and adapted to be operated by the human hand, the method comprising introducing the distal extremity of the first elongated tubular member and the expansile member through the wall into the lumen of the vessel so that the expansile member is disposed distally of the wall of the vessel, moving the expansile member from a contracted configuration to an expanded configuration, pulling the first elongated tubular member proximally to bring the expansile member into engagement with the wall of the vessel and waiting for a predetermined amount of time, thereafter moving the expansile member from the expanded configuration to a contracted configuration and removing the device from the vessel.

48. The method as in claim 47 together with the step of applying a predetermined proximal force of tension to the expansile member after bringing the expansile member into engagement with the wall of the lumen of the vessel and releasing said tension before moving the expansile member from the expanded configuration to a contracted configuration.

49. The method as in claim 47 together with the steps of introducing a biological sealant after the expansile member has been brought into engagement with the wall of the vessel to cause the biological sealant to surround the distal extremity of the first elongated tubular member and to fill the space between the wall of the vessel and the expansile member, permitting the biological sealant to cure for a predetermined amount of time, thereafter moving the expansile member from the expanded configuration to a contracted configuration and removing the expansile member from the biological sealant.

51. The device as in 50 wherein said membrane is formed to permit movement of the expansile member within the membrane and to constrain said expansile member from the free state configuration into said expanded configuration during movement between contracted and expanded configurations.

52. The device as in claim 51 wherein said expansile member has a first dimension, said first dimension in the free state configuration being larger than said first dimension in said expanded configuration.

53. A device for expansion within a blood vessel having a wall defining a lumen in the body comprising a first elongated tubular member having proximal and distal extremities and having a longitudinal axis, an expansile member carried by the distal extremity of the first elongated tubular member and movable between contracted and expanded configurations, said expansile member being constructed essentially of a superelastic material having a free state and having a configuration in the free state which has a substantially different configuration than the expanded configuration of said expansile member, a deformable membrane at least partially covering the expansile member in the expanded configuration, said membrane being formed to permit movement of the expansile member within the membrane and to constrain said expansile member from the substantially different free state configuration into said expanded configuration during movement between contracted and expanded configurations and deployment means carried by the proximal extremity of the first elongated tubular member and coupled to the expansile member, said deployment means being adapted to be operated by the human hand for controlling movement of the expansile member between the contracted and expanded configurations.

54. The device as in claim 53 wherein said expansile member has a first dimension, said first dimension in the free state configuration being larger than said first dimension in said expanded configuration.

55. A device for expansion within a blood vessel having a wall defining a lumen in the body comprising a first elongated tubular member having proximal and distal extremities and having a longitudinal axis, an expansile member carried by the distal extremity of the first elongated tubular member and movable between contracted and expanded configurations, a deformable membrane at least partially covering the expansile member, said deformable membrane being sized so as to be capable of expanding as the expansile member moves from the contracted configuration to the expanded configuration and deployment means carried by the proximal extremity of the first elongated tubular member and directly connected to the expansile member, said deployment means being adapted to be capable of moving the expansile member between the contracted and expanded configurations.

56. A device for expansion within a blood vessel having a wall defining a lumen in the body comprising a first elongated tubular member having proximal and distal extremities and having a longitudinal axis, an expansile member carried by the distal extremity of the first elongated tubular member and movable between contracted and expanded configurations, a deformable membrane carried by the distal extremity of said first elongated tubular member, said deformable membrane being sized so as to be capable of expanding to have a first layer underlying and a second layer overlying the expansile member in the expanded configuration and deployment means carried by the proximal extremity of the first elongated tubular member and coupled to the expansile member, said deployment means being adapted to be operated by the human hand for controlling movement of the expansile member between the contracted and expanded configurations.

57. A device for expansion within a vessel having a wall defining a lumen in the body comprising an elongated tubular member having proximal and distal extremities and having a lumen extending from the proximal extremity to the distal extremity and having a longitudinal axis, a sock-shaped flexible membrane having an open end secured to the distal extremity of the elongated tubular member, an expansile member free of the sock-shaped flexible membrane slidably mounted in the lumen in the elongated tubular member for movement into and out of the lumen and into and out of said sock-shaped membrane, said expansile member having a configuration so that when it is moved out of the lumen it will expand to engage the sock-shaped flexible membrane and serve to move the sock-like flexible membrane into a disk-like shape aligned generally in a plane perpendicular to the elongated tubular member, and push-pull means disposed within the lumen and secured to the expansile member for moving said expansile member into and out of said lumen in the elongated tubular member, said push-pull means being accessible from the proximal extremity of the elongated tubular member.