INSERTION GUIDE

• US 20170258489A1
• Filed: 11/28/2015
• Published: 09/14/2017
• Est. Priority Date: 11/29/2014
• Status: Active Grant

• Current Assignee: XACT Robotics Ltd.
• Original Assignee: XACT Robotics Ltd.
• Inventors: GALILI, Ben, ARNOLD, Ofer, SHARON, Simon, GLOZMAN, Daniel
• Granted Patent: US 11,083,488 B2
• Time in Patent Office: Days
• CPC Class Codes: A61B 10/04 Endoscopic instruments
• CPC Class Codes: A61B 17/3403 Needle locating or guiding means guides for suture needles A61B17/0482; guiding or tracking by nuclear magnetic resonance G01R33/285
• CPC Class Codes: A61B 2010/045 Needles pointed biopsy devices with vacuum aspiration A61B10/0283
• CPC Class Codes: A61B 2017/00991 Telescopic means
• CPC Class Codes: A61B 2017/3409 including needle or instrument drives
• CPC Class Codes: A61B 2034/2055 Optical tracking systems
• CPC Class Codes: A61B 2034/2059 Mechanical position encoders
• CPC Class Codes: A61B 34/20 Surgical navigation systems; Devices for tracking or guiding surgical instruments, e.g. for frameless stereotaxis
• CPC Class Codes: A61M 2025/0008 having visible markings on its surface, i.e. visible to the naked eye, for any purpose, e.g. insertion depth markers, rotational markers or identification of type
• CPC Class Codes: A61M 2025/0166 Sensors, electrodes or the like for guiding the catheter to a target zone, e.g. image guided or magnetically guided
• CPC Class Codes: A61M 25/0113 Mechanical advancing means, e.g. catheter dispensers
• CPC Class Codes: A61M 39/02 Access sites
• CPC Class Codes: A61N 1/372 Arrangements in connection with the implantation of stimulators

Abstract

A device for insertion of a flexible needle or other such instrument into a tissue, incorporating a collapsible support guide which supports that part of the needle which has not yet penetrated the tissue, preventing it from buckling, and an arrangement which pulls the needle from its proximal end to provide sufficient force for the penetration process. The collapsible support guide can be a pair of flexible strips connected along their length and enclosing the needle along its uninserted length in order to support it, with a mechanism at the distal end of the device to peel the strips from the needle as it is inserted. Insertion can be achieved by a pair of rollers engaging and advancing the strips distally. Alternatively, a telescopic support tube can be used to support the needle, the tube collapsing telescopically as the needle is inserted, to maintain clearance above the needle.

Claims

26. An assembly for insertion of a tool, comprising:

an insertion module comprising;

a guide member having an opening adapted to allow passage of said tool therethrough;

a propulsion mechanism configured to advance said tool through said opening in the direction of an insertion site; and

a buckling prevention mechanism configured to support said tool along at least a portion of its length during its advance in the direction of the insertion site;

a housing configured to receive said insertion module; and

an actuation mechanism configured to activate said propulsion mechanism.

1. A device for insertion of a tool, comprising:

a guide member having an opening adapted to allow passage of said tool therethrough;

a propulsion mechanism configured to advance said tool through said opening in the direction of an insertion site; and

a buckling prevention mechanism configured to support said tool along at least a portion of its length while it is advanced in the direction of the insertion site;

wherein the device is configured such that its height relative to the insertion site decreases as said tool is advanced in the direction of the insertion site.

2. An insertion device according to claim 1, further comprising a head element to which said tool is coupled at its proximal region.

3. An insertion device according to claim 2, wherein the propulsion mechanism includes the buckling prevention mechanism and comprises:

a pair of flexible strips connected along at least part of their length and having a central channel therebetween adapted to receive and support said tool, said pair of strips being coupled at its proximal region to said head element; and

a pair of rollers disposed on either side of said pair of flexible strips, and interacting therewith such that counter-rotation of said pair of rollers causes said pair of flexible strips to move between said pair of rollers;

wherein upon said tool being received within said central channel, said pair of flexible strips and said tool are connected by means of said head element, such that counter-rotation of said rollers in an appropriate direction pulls said pair of flexible strips and said tool towards said pair of rollers.

4. An insertion device according to claim 3, wherein each roller of said pair of rollers comprises a plurality of protrusions arranged along its circumference, said plurality of protrusions being adapted to engage with a corresponding plurality of holes formed along the length of each strip of said pair of flexible strips.

5. An insertion device according to either of claims 3 and 4, wherein said pair of flexible strips is connected on at least one side of said central channel adapted to receive said tool.

6. An insertion device according to any of claims 3 to 5, wherein said pair of flexible strips is not connected in a region of said central channel adapted to receive said tool.

7. An insertion device according to any of claims 3 to 6, further comprising a separating feature adapted to direct each strip of said pair of flexible strips around one of said pair of rollers.

8. An insertion device according to claim 7, wherein said separating feature comprises unconnected distal ends of said pair of flexible strips, each of said unconnected distal ends being wound around an associated roller of said pair of rollers.

9. An insertion device according to claim 3, wherein each roller of said pair of rollers comprises a plurality of ridges arranged along its circumference, said ridges being adapted to engage with corresponding ridges formed in said pair of flexible strips.

10. An insertion device according to any of claims 3 to 9, wherein said central channel includes weakened sections along its length to facilitate the winding of each strip of said pair of flexibles strip around its associated roller.

11. An insertion device according to any of claims 3 to 10, wherein the insertion device comprises two separate units adapted to be connected to and disconnected from each other, each unit comprising:

one strip of said pair of strips;

one roller of said pair of rollers; and

at least a portion of said guide member.

12. An insertion device according to claim 1, wherein the buckling prevention mechanism comprises a telescopic tube.

13. An insertion device according to claim 12, further comprising a head element to which said tool is coupled at its proximal region, wherein said telescopic tube is attached between said head element and said guide member.

14. An insertion device according to either of claims 12 and 13, further comprising at least one gripping member connected to said telescopic tube, said at least one gripping member being configured to receive said tool and to support it as it advances in the direction of the insertion site.

15. An insertion device according to either of claims 12 and 13, wherein said tool is enclosed within said telescopic tube.

16. An insertion device according to any of claims 13 to 15, wherein said head element is moved towards said guide member by means of a cable attached between said head element and said guide member.

17. An insertion device according to claim 16, wherein said cable is wound around a pulley attached to said guide member.

18. An insertion device according to claim 1, wherein the propulsion mechanism comprises one or more piezo-electric actuators.

19. An insertion device according to any of the previous claims, wherein said opening further comprises a constraining mechanism configured to be adjusted according to the dimensions of said tool, at least a portion of said constraining mechanism being disposed within said opening.

20. An insertion device according to claim 19, wherein said constraining mechanism comprises at least two portions disposed opposite each other, and wherein at least one of said at least two portions is adapted to be moved towards another of said at least two portions.

21. An insertion device according to claim 20, wherein said constraining mechanism further comprises a tightening screw.

22. An insertion device according to any of the previous claims, further comprising an encoder configured to determine the position of said tool.

23. An insertion device according to claim 22, wherein said encoder is an optical encoder configured to determine the position of said tool by one or more of:

sensing markings on said tool and sensing features on one or more components of said buckling prevention mechanism.

24. An insertion device according to any of the previous claims, wherein the insertion device comprises two separate units adapted to be connected to and disconnected from each other, each unit comprising:

at least a portion of the guide member;

at least a portion of the propulsion mechanism; and

at least a portion of the bucking prevention mechanism.

25. An insertion device according to any of the previous claims, wherein said tool comprises one or more of:

a needle, a cannula, a catheter, an introducer, a port, a fluid delivery tube or an electrode rod.

27. An insertion assembly according to claim 26, wherein said insertion module is configured such that its height relative to the insertion site decreases as said tool advances in the direction of the insertion site.

28. An insertion assembly according to either of claims 26 and 27, wherein said insertion module further comprises a head element to which said tool is coupled at its proximal region.

29. An insertion assembly according to any of claims 26 to 28, wherein the propulsion mechanism includes the buckling prevention mechanism and comprises:

a pair of flexible strips connected along at least part of their length and having a central channel therebetween adapted to receive and support said tool, said pair of strips being coupled at its proximal region to said head element; and

a pair of rollers disposed on either side of said pair of flexible strips, and interacting therewith such that counter-rotation of said pair of rollers causes said pair of flexible strips to move between said pair of rollers;

wherein upon said tool being received within said central channel, said pair of flexible strips and said tool are connected by means of said head element, such that counter-rotation of said rollers in an appropriate direction pulls said pair of flexible strips and said tool towards said pair of rollers.

30. An insertion assembly according to claim 29, wherein each roller of said pair of rollers comprises a plurality of protrusions arranged along its circumference, said plurality of protrusions being adapted to engage with a corresponding plurality of holes formed along the length of each strip of said pair of flexible strips.

31. An insertion assembly according to either of claims 29 and 30, wherein the distal ends of said pair of flexible strips are unconnected, each of said unconnected distal ends being wound around an associated roller of said pair of rollers.

32. An insertion assembly according to any of claims 26 to 31, wherein the insertion module comprises two separate units adapted to be connected to and disconnected from each other, each unit comprising:

one strip of said pair of strips;

one roller of said pair of rollers; and

at least a portion of said guide member.

33. An insertion assembly according to claim 32, wherein the buckling prevention mechanism further comprises at least one gripping member connected to said telescopic tube, said gripping member being configured to receive said tool and to support it as it advances in the direction of the insertion site.

34. An insertion assembly according to claim 26, wherein the propulsion mechanism comprises one or more piezo-electric actuators.

35. An insertion assembly according to any of claims 26 to 33, further comprising an encoder configured to determine the position of said tool.

36. An insertion assembly according to any of claims 26 to 35, wherein said tool comprises one or more of:

a needle, a cannula, a catheter, an introducer, a port, a fluid delivery tube or an electrode rod.

37. An insertion assembly according to claim 26, wherein a first portion of said actuation mechanism is coupled to said housing, and a second portion of said actuation mechanism is coupled to said guide member of the insertion module.

38. An insertion assembly according to any of claims 26 to 37, further comprising a locking mechanism configured to lock said insertion module within said housing.

39. An insertion assembly according to claim 38, wherein said locking mechanism comprises:

a rotating member coupled to said insertion module; and

one or more slits formed in said housing;

wherein rotation of said rotating member such that at least a portion of said rotating member enters at least one of said one or more slits, locks said insertion module within said housing.

40. An insertion assembly according to any of claims 26 to 39, wherein said housing comprises one or more coupling elements adapted to couple said housing to an automated insertion device, said automated insertion device including at least a controller.

41. An insertion assembly according to any of claims 26 to 40, wherein the insertion module comprises two separate units adapted to be connected to and disconnected from each other, each unit comprising:

at least a portion of the guide member;

at least a portion of the propulsion mechanism; and

at least a portion of the bucking prevention mechanism.

44. An insertion device according to either of claims 42 and 41, wherein said pair of flexible strips are connected on at least one side of said central channel adapted to receive said tool, and are not connected in a region of said central channel.

32-1. An insertion assembly according to claim 26, wherein the buckling prevention mechanism comprises a telescopic tube.

42. A device for insertion of a tool, comprising:

a pair of flexible strips connected along at least part of their length and having a central channel therebetween adapted to receive said tool; and

a pair of rollers disposed on either side of said pair of flexible strips, and interacting therewith such that counter-rotation of said pair of rollers causes said pair of flexible strips to move between said pair of rollers;

wherein upon said tool being received within said central channel, said pair of flexible strips and said tool are secured together at an end remote from said pair of rollers, such that counter-rotation of said rollers in an appropriate direction pulls said pair of flexible strips and said tool towards said pair of rollers.

43. An insertion device according to claim 42, wherein each roller of said pair of rollers comprises a plurality of protrusions arranged along its circumference and adapted to engage with corresponding plurality of holes formed along the length of each strip of said pair of flexible strips.

45. An insertion device according to any claims 42 to 44, further comprising a holder member configured to secure together said pair of flexible strips and said tool.

46. An insertion device according to any of claims 42 to 45, further comprising a guide member, the guide member including:

one or more cavities adapted to accommodate said pair of rollers; and

an opening adapted to allow passage of said tool therethrough.

47. An insertion device according to claim 46, wherein said opening further comprises a constraining mechanism configured to be adjusted according to the dimensions of said tool, at least a portion of said constraining mechanism being disposed within said opening.

48. An insertion device according to claim 47, wherein said constraining mechanism comprises at least two portions disposed opposite each other, and wherein at least one of said at least two portions is adapted to be moved towards another of said at least two portions.

49. An insertion device according to any of claims 42 to 48, further comprising a separating feature adapted to direct each strip of said pair of flexible strips around one of said pair of rollers.

50. An insertion device according to claim 49, wherein said separating feature comprises unconnected distal ends of said pair of flexible strips, each of said unconnected distal ends being wound around an associated roller of said pair of rollers.

51. An insertion device according to claim 49, wherein said separating feature comprises a pair of structural edges, each being disposed sufficiently close to an associated roller that each flexible strip is directed by one of said edges around that roller disposed close to said edge.

52. An insertion device according to claim 49, wherein said pair of rollers is disposed within a guide member, and each of said structural edges are the edges of a component of said guide member.

53. An insertion device according to any of claims 42 to 52, wherein said central channel includes weakened sections along its length to facilitate the winding of each flexible strip around its associated roller.

54. An insertion device according to any of claims 42 to 53, wherein the distance between two adjacent protrusions of said plurality of protrusions is larger than the distance between two adjacent holes of said plurality of holes.

55. An insertion device according to claim 42, wherein the external surfaces of said pair of rollers and the external surfaces of said pair of flexible strips are roughened such that the interaction between them is achieved by means of friction.

56. An insertion device according to any of claims 42 to 54, wherein said tool comprises a tip, and the insertion device further comprises a protecting element configured to prevent said tip from contacting an internal surface of said central channel as said tool is advanced in the direction of the insertion site.

57. An insertion device according to claim 56, wherein said protecting element is inserted within said central channel.

58. An insertion device according to claim 57, wherein said protecting element comprises a hollow tube.

59. An insertion device according to claim 56, wherein said protecting element is coupled to at least a portion of said insertion device externally to said central channel.

60. An insertion device according to any of claims 42 to 59, wherein the insertion device comprises two separate units adapted to be connected to and disconnected from each other, each unit comprising:

one strip of said pair of strips; and

one roller of said pair of rollers.

61. An assembly for insertion of a tool, comprising:

an insertion module comprising;

a pair of flexible strips connected along at least part of their length and having a central channel therebetween adapted to receive said tool; and

a pair of rollers disposed on either side of said pair of flexible strips, and interacting therewith such that counter-rotation of said pair of rollers causes said pair of flexible strips to move between said pair of rollers;

wherein upon said tool being received within said central channel, said pair of flexible strips and said tool are secured together at an end remote from said pair of rollers, such that counter-rotation of said rollers in an appropriate direction pulls said pair of flexible strips and said tool towards said pair of rollers;

a housing configured for receiving said insertion module; and

an actuation mechanism configured to rotate said pair of rollers.

62. An insertion assembly according to claim 61, wherein a first portion of said actuation mechanism is coupled to said housing.

63. An insertion assembly according to claim 62, wherein the insertion module comprises a second portion of said actuation mechanism.

64. An insertion assembly according to any of claims 61 to 63, further comprising a locking mechanism configured to lock said insertion module within said housing.

65. An insertion assembly according to claim 64, wherein said locking mechanism comprises:

a rotating member coupled to said insertion module; and

one or more slits formed in said housing;

wherein rotation of said rotating member such that at least a portion of said rotating member enters at least one of said one or more slits locks said insertion module within said housing.

66. An insertion assembly according to any of claims 61 to 65, further comprising a separating feature adapted to direct each strip of said pair of flexible strips around one of said pair of rollers.

67. An insertion assembly according to claim 66, wherein said separating feature comprises unconnected distal ends of said pair of flexible strips, each of said unconnected distal ends being wound around an associated roller of said pair of rollers.

68. An insertion assembly according to any of claims 61 to 67, further comprising:

a front leading element coupled to said insertion module; and

a back leading element coupled to said housing;

wherein said front and back leading elements are configured to receive therebetween one of said unconnected ends of said pair of strips after said one of said unconnected ends is wound around its associated roller of said pair of rollers.

69. An insertion assembly according to any of claims 61 to 68, wherein said housing comprises one or more coupling elements adapted to couple said housing to an automated insertion device, said automated insertion device including at least a controller.

70. An insertion assembly according to any of claims 61 to 69, wherein the insertion module comprises two separate units adapted to be connected to and disconnected from each other, each unit comprising:

one strip of said pair of strips; and

one roller of said pair of rollers.

71. A device for insertion of a tool, comprising:

a head element to which said tool is attached at a proximal region of said tool;

an end guide element through which said tool is delivered to an insertion site; and

a telescopic tube attached between said head element and said end guide element,

wherein as said telescopic tube collapses, said head element is moved towards said end guide element and said tool advances towards the insertion site.

72. An insertion device according to claim 71, wherein said head element is moved towards said end guide element by means of a cable attached between said head element and said end guide element.

73. An insertion device according to claim 72, wherein said cable is wound around a pulley attached to said end guide element.

74. An insertion device according to any of claims 71 to 73, further comprising at least one gripping element configured to receive said tool and to support it as it advances in the direction of the insertion site.

75. An insertion device according to any of claims 71 to 73, wherein said tool is enclosed within said telescopic tube.