Vascular treatment device

• US 7,967,834 B2
• Filed: 09/13/2007
• Issued: 06/28/2011
• Est. Priority Date: 09/13/2006
• Status: Active Grant

• Current Assignee: Merit Medical Systems, Inc.
• Original Assignee: Vascular Insights LLC (Merit Medical Systems, Inc.)
• Inventors: Marano, John P. Jr., Thompson, Stanley O., Tal, Michael G., Labak, Chris
• Primary Examiner(s): SONNETT, KATHLEEN C
• Application Number:
  US12/438,314
• Publication Number:
  US 20090270889A1
• Time in Patent Office: 1,384 Days
• Field of Search: 606/79, 606/80, 606/159, 606167-180, 606/81, 606/127, 606/128, 604/22, 604/110, 604/111, 604/103.05, 604/192, 200/43.09, 200/51.R, 200/51.09, 200/51.1
• US Class Current: 606/159
• CPC Class Codes: A61B 17/00008 Vein tendon strippers tube strippers A61M1/83
• CPC Class Codes: A61B 17/320758 with a rotating cutting instrument, e.g. motor driven A61B17/320725, A61B17/32075 and A61B17/320783 take precedence; for removing intra-ocular material A61F9/00763; endoscopic rotatable cutting instruments A61B17/32002
• CPC Class Codes: A61B 2017/00398 using powered actuators, e.g. stepper motors, solenoids
• CPC Class Codes: A61B 2017/0046 with a releasable handle; with handle and operating part separable for prosthetic joint-implanting tools A61F2/4603
• CPC Class Codes: A61B 2017/00477 Coupling A61B2017/0046 takes precedence
• CPC Class Codes: A61B 2017/00778 Operations on blood vessels A61B2017/22097, A61B2017/320741 take precedence
• CPC Class Codes: A61B 2017/22084 stone- or thrombus-dissolving

Abstract

A vascular treatment device may include (1) a handle having a motor, a trigger, and a male coupling, and (2) a cartridge, engageable to the handle, having a female coupling, a wire, and a sheath fixed to the cartridge. When the female coupling is not engaged to the male coupling, the sheath may cover the distal end of the wire, allowing safe advancement of the device into the patient'"'"'s vasculature, and when the female coupling is engaged by the male coupling, the distal end of the wire may be exposed from the sheath and used.

Claims

1. A vascular treatment device comprising:

a handle having;

a motor;

a trigger mounted on the handle and transitionable between a first state that does not electrically couple the motor to a power source and a second state that does couple the motor to the power source; and

a male coupling rotably driven by the motor; and

a cartridge engageable with the handle and having;

a female coupling so sized and shaped as to be engageable by, and once engaged by, to be rotated by the male coupling;

a wire having a proximal end fixed to the female coupling, a main shaft extending therefrom and terminating at a distal end; and

a sheath fixed to and extending from the cartridge, the sheath defining a lumen through which the wire runs;

wherein the sheath, when the female coupling is not engaged by the male coupling, covers the distal end of the wire, and

wherein as the male coupling and the female coupling fully engage each other and the cartridge is engaged with the handle, the male coupling displaces female coupling detents to allow the female coupling to slide within the cartridge, thereby causing the sheath, when the female coupling is engaged by the male coupling, to slide back relative to the wire and uncover the distal end of the wire.

2. The device of claim 1, further comprising a microswitch interposed in an electrical circuit connecting the trigger and the motor and transitionable by engagement of the cartridge and the handle from an open state to a closed state, thereby permitting the trigger and motor to be electrically coupled to one another.

3. The device of claim 1, wherein the system comprises a gate that is biased to a first position that prevents engagement of the cartridge and the handle and is transitionable to a second position that permits engagement of the cartridge and the handle.

4. The device of claim 3, wherein the gate is further transitionable to a third position that prevents disengagement of the cartridge and the handle.

5. The device of claim 4, wherein the third position is intermediate the first and second positions.

6. The device of claim 4, wherein the gate, when in the third position, is received in a detent defined in the cartridge.

7. The device of claim 3, wherein the gate is biased to the first position by a spring contacting the handle.

8. The device of claim 3, wherein the gate is physically coupled to a switch on the handle such that movement of the switch transitions the gate between the first position and the second position.

9. The device of claim 1, wherein the handle includes a potentiometer electrically coupled to the motor to control a speed of the motor.

10. The device of claim 1, wherein the male coupling is biased toward an expanded state and transitionable from the expanded state to a contracted state.

11. The device of claim 10, wherein the female coupling is so sized and shaped as to transition the male coupling from the expanded state to the contracted state during engagement of the handle and the cartridge.

12. The device of claim 10, wherein the male coupling is so sized and shaped as to return to the expanded state once the cartridge and the handle are fully engaged.

13. The device of claim 10, wherein the male coupling comprises at least two prongs separated by slitted portions.

14. The device of claim 1, wherein the sheath has an inner diameter between 0.022 inches to 0.048 inches.

15. The device of claim 1, wherein the sheath has an outer diameter between 0.020 inches to 0.050 inches to facilitate insertion into a vein.

16. The device of claim 1, wherein one or more portions of the handle define a trigger ring in which the trigger is at least partly disposed, and wherein the handle is so arranged as to be balanced when supported from only one or more portions of the handle that define the trigger ring.

17. The device of claim 1, wherein the sheath comprises external markings at regular intervals.

18. The device of claim 1, wherein:

the distal end comprises, in proximal-to-distal order, a first segment, a second segment, and a third segment;

the first segment extends between the main shaft and the second segment and is biased to rest at a first included angle that is;

defined between the main shaft and the first segment; and

less than 180 degrees;

the second segment extends between the first segment and the third segment and is biased to rest at a second included angle that is;

defined between the first segment and the second segment; and

is less than 180 degrees; and

the third segment extends from the second segment to a free end and is biased to rest at a third included angle that is;

defined between the second segment and the third segment; and

is less than 180 degrees.

19. The device of claim 18, wherein the second included angle is greater than the first included angle.

20. The device of claim 18, wherein the sum of the first included angle and the third included angle, minus the second included angle, is in the range of about 70 degrees to about 110 degrees.

21. The device of claim 20, wherein the sum of the first included angle and the third included angle, minus the second included angle, is in the range of about 80 degrees to about 100 degrees.

22. The device of claim 21, wherein the sum of the first included angle and the third included angle, minus the second included angle, is about 90 degrees.

23. The device of claim 18, wherein the third segment has a length that is smaller than an inner diameter of the sheath.

24. The device of claim 23, wherein the third segment has a length of less than 0.028 inches.

25. The device of claim 23, wherein the third segment has a length that is equal to or smaller than two-thirds of the inner diameter of the sheath.

26. The device of claim 18, wherein a perpendicular length measured from an axis defined by the main shaft to the free end is less than 0.3 inches.

27. The device of claim 18, wherein the first and second segments each have a length in the range of about 0.2 inches to about 0.3 inches.

28. The device of claim 27, wherein the first and second segments each have lengths in the range of about 0.24 inches to about 0.26 inches.

29. The device of claim 28, wherein the length of the first segment is in the range of about 0.248 inches to about 0.25 inches, and the length of the second segment is in the range of about 0.25 inches to about 0.252 inches.

30. The device of claim 29, wherein the length of the first segment is 0.249 inches, and the length of the second segment is 0.2504 inches.

31. The device of claim 18, wherein the distal end has at least two linear segments oriented at a non-zero angle relative to one another.

32. The device of claim 18, wherein the free end is ball-shaped.

33. The device of claim 1, wherein the distal end of the wire terminates with a hemispheric free end.

34. The device of claim 1, wherein the distal end of the wire terminates with a pointed free end.

35. The device of claim 1, wherein the distal end of the wire terminates with a textured hemispheric free end.

36. The device of claim 1, wherein the distal end of the wire terminates with a flat free end.

37. The device of claim 1, wherein the wire distal end is weighted.

38. The device of claim 37, wherein the distal end is eccentrically weighted relative to the main shaft.

39. The device of claim 1, wherein the distal end has a roughened surface.

40. The device of claim 1, wherein the wire further comprises a spring attached along the distal end.

41. The device of claim 1, wherein the wire distal end comprises a curved segment.

42. The device of claim 41, wherein the wire distal end comprises a straight segment distal to the curved segment.

43. The device of claim 1, further comprising a syringe in fluid communication with the sheath lumen.

44. The device of claim 43, wherein the syringe is attached to the cartridge.

45. The device of claim 43, wherein the syringe is attachable to the cartridge with or without a stopcock.

46. The device of claim 43, wherein the handle further comprises a support so positioned as to receive the syringe.

47. The device of claim 43, wherein the handle and the syringe are so sized, shaped, and positioned as to permit a user to actuate the trigger with the index finger of a hand and simultaneously depress a plunger into the syringe with the thumb of the same hand.

48. The device of claim 1, wherein the handle:

comprises a casing formed from two pieces;

contains the motor and the male coupling; and

defines a receptacle in which the male coupling is positioned and which receives the female coupling of the cartridge when the cartridge and the handle engage.

49. The device of claim 1, wherein the distal end of the wire comprises a single linear segment extending between the main shaft and a ball-shaped free end and is biased to rest at a first included angle that is defined between the main shaft and the linear segment and is less than 180 degrees.

50. The device of claim 49, wherein the first included angle is 140 degrees.