阅读说明：本技术 超弹性医疗器械 (Super-elastic medical instrument ) 是由 卡塞伊·蒂尔·兰迪 瑞安·杰弗里·康诺利 于 2018-04-04 设计创作，主要内容包括：特定方面涉及一种超弹性医疗器械,该超弹性医疗器械弹性弯曲穿过内窥镜的曲折路径、在从内窥镜部署时恢复成直的形状、并且沿着支气管窥镜的端部的轴线(在容许裕量范围内)笔直地部署了2cm或更大的距离。(Certain aspects relate to a superelastic medical device that elastically bends through a tortuous path of an endoscope, returns to a straight shape when deployed from the endoscope, and is deployed straight along the axis of the end of a bronchoscope (within an allowable margin) for a distance of 2cm or greater.)

1. A biopsy needle assembly comprising:

a needle formed from a superelastic alloy, the needle comprising:

a body portion extending from a distal end of the needle to a proximal end of the needle, an

An inner surface of the needle forming a lumen extending through at least a portion of the body portion to an opening in the distal end, wherein the lumen and the opening are configured to take a tissue biopsy;

an elongate member attached at the proximal end of the needle; and

a tubular sheath comprising an internal passage, wherein:

in a first configuration, the distal end of the needle is positioned within the internal passage, and

in a second configuration, the distal end of the needle extends beyond a distal end of the tubular sheath in response to distal movement of the elongate member through the internal passage.

2. The assembly according to claim 1, wherein the superelastic alloy comprises a nickel titanium alloy.

3. The assembly of claim 1, wherein the needle has a wall thickness of about 0.0015 inches thick.

4. The assembly of claim 1, further comprising a sharp tip at the distal end of the needle.

5. The assembly of claim 4, further comprising a radiopaque material positioned around the needle near the sharp tip.

6. The assembly of claim 5, wherein the radiopaque material comprises gold.

7. The assembly of claim 5, wherein the radiopaque material has a thickness of at least 200 microinches.

8. The assembly of claim 1, wherein the elongate member comprises a polymer tube reflowed about an overlap region at the proximal end of the needle.

9. The assembly of claim 8, wherein the polymer tube includes a tapered section at a distal end of the polymer tube before or after being reflowed about the overlap region.

10. The assembly of claim 8, wherein the polymer tube comprises a flexible thermoplastic.

11. The assembly of claim 8, wherein the needle has a length of about 5 centimeters from the distal end to the proximal end, and wherein the overlap region has a length of about 2 centimeters.

12. The assembly of claim 8, wherein the needle has a length of about 4 centimeters from the distal end to the proximal end, and wherein the overlap region has a length of about 1 centimeter.

13. The assembly of claim 8, wherein the needle has a length between 1 and 6 centimeters.

14. The assembly of claim 8, wherein the overlap region has a length of 0.5cm to 3 cm.

15. The assembly of claim 8, wherein a channel formed by an inner surface of the polymer tube is in fluid communication with the cavity to provide pressure through the opening.

16. The assembly of claim 8, further comprising a plurality of surface features formed on the pin at the overlap region, wherein the polymer tube is reflowed around the surface features.

17. The assembly of claim 16, wherein the plurality of surface features comprises a blasted outer surface of the needle.

18. The assembly of claim 16, wherein the plurality of surface features comprise laser-cut holes that each extend through a wall of the needle.

19. The assembly of claim 8, wherein the overlap region is at a distal end of the tube.

20. The assembly of claim 19, wherein the proximal end of the needle comprises a first helical channel or cut and the distal end of the tube comprises a second helical channel or cut configured to mechanically mate with the first helical channel or cut.

21. The assembly of claim 19, wherein the proximal end of the needle and the distal end of the tube are secured at the overlap region by a flexible adhesive.

22. The assembly of claim 19, wherein the proximal end of the needle and the distal end of the tube are secured at the overlap region by screws.

23. The assembly of claim 1 wherein the superelastic alloy is in its austenite phase in an original shape in which the body portion is straight.

24. The assembly according to claim 1, wherein the superelastic alloy is reversibly deformable up to 10% from the original shape in its martensite phase.

25. A method of obtaining a tissue biopsy, the method comprising:

positioning a distal end of a working channel of an endoscope adjacent to a desired biopsy site;

advancing a tubular sheath through the working channel, the sheath including a biopsy needle assembly positioned within the sheath, the biopsy needle assembly including:

a needle formed from a superelastic alloy, the needle comprising:

a body portion extending from a distal end of the needle to a proximal end of the needle, an

An inner surface of the needle forming a lumen extending through at least a portion of the body portion to an opening in the distal end, wherein,

the cavity and the opening are configured to take a tissue biopsy; and

an elongate member attached at the proximal end of the needle;

actuating a first linear movement of a proximal end of the elongate member to drive at least a portion of the needle out of the sheath into the biopsy site;

obtaining a tissue sample from the biopsy site through the opening of the needle; and

actuating a second linear movement of the proximal end of the elongate member to drive the needle to retract from the biopsy site.

26. The method of claim 25, further comprising applying pressure within the lumen to obtain the tissue biopsy.

27. The method of claim 25, wherein the sheath has a handle coupled to a proximal end thereof, the handle configured to actuate the first and second linear motions of the proximal end of the elongate member along a longitudinal axis of the handle, the method further comprising actuating the handle to control the extension and retraction of the needle.

28. The method of claim 27, further comprising robotically controlling actuation of the handle.

29. The method of claim 25, wherein the elongate member comprises a polymer tube secured at an overlap region at the proximal end of the needle, the method further comprising:

positioning a distal end of the sheath a predetermined distance from the tissue site, the predetermined distance being less than a length of the needle that extends distally beyond the overlap region; and is

Wherein actuating the first linear motion comprises:

performing a first actuation of the needle to extend the needle out of the sheath;

determining that the distal end of the needle is positioned outside of the sheath; and

performing a second actuation of the needle to extend the needle into the biopsy site.

30. The method of claim 29, further comprising determining that the overlap region remains at least partially positioned within the sheath after the first drive and before the second drive.

31. The method of claim 29, further comprising determining that the overlap region remains at least partially positioned within the working channel of the endoscope after the first actuation and before the second actuation.

32. The method of claim 29, wherein performing the second drive includes alternating a plurality of times extending the needle into the biopsy site and retracting the needle from the biopsy site.

33. The method of claim 25, further comprising:

viewing the biopsy site with fluoroscopy; and

determining that the distal end of the needle is positioned at the biopsy site by observing, via the fluoroscopy, a radiopaque material positioned around the needle near the distal end of the needle.

34. The method of claim 25, wherein advancing the tubular sheath through the working channel comprises advancing the needle through a curved portion of the working channel, and wherein advancing the needle through the curved portion reversibly deforms the needle up to 10% from an original shape of the needle in which the body portion is straight.

35. The method of claim 34, wherein reversibly deforming the needle comprises transforming the superelastic alloy from an austenite phase, in which the needle assumes the original shape, to a martensite state.

36. The method of claim 35, wherein driving the at least a portion of the needle out of the sheath into the biopsy site comprises automatically transitioning the at least a portion of the needle back to the austenite phase and back to the original shape.

37. A robotic needle biopsy system comprising:

a needle formed from a superelastic material, the needle including an inner surface forming a lumen extending through a body portion of the needle from an opening in a proximal end of the needle to an opening in a distal end of the needle, wherein the lumen and the opening in the distal end are configured to obtain a tissue biopsy;

an elongate member secured at the proximal end of the needle;

a tubular sheath comprising an internal channel positioned about the needle and at least a portion of the elongate member; and

a control system configured to move the elongate member to drive the needle between a first configuration and a second configuration, wherein in the first configuration the distal end of the needle is positioned within the internal passage of the tubular sheath, and wherein in the second configuration the distal end of the needle extends beyond a distal end of the tubular sheath.

38. The robotic needle biopsy system of claim 37, the needle further comprising a sharp tip at the distal end of the needle.

39. The robotic needle biopsy system of claim 38, the needle further comprising a radiopaque material positioned about the body portion of the needle near the sharp tip.

40. The robotic needle biopsy system of claim 39, wherein the radiopaque material comprises a gold pattern.

41. The robotic needle biopsy system of claim 39, wherein the radiopaque material has a thickness in a range from about 200 micro-inches to about 1000 micro-inches.

42. The robotic needle biopsy system of claim 37, wherein the elongate member comprises a polymer tube secured around an overlap region at the proximal end of the needle.

43. The robotic needle biopsy system of claim 42, wherein the polymer tube comprises a flexible thermoplastic that is reflowed around the overlap region.

44. The robotic needle biopsy system of claim 43, wherein the needle has a length of about 5cm from the distal end to the proximal end, and wherein the overlap region has a length of about 2 cm.

45. The robotic needle biopsy system of claim 44, wherein the robotic system is configured to advance the distal end of the needle beyond the distal end of the tubular sheath by up to 3cm in the second configuration.

46. The robotic needle biopsy system of claim 42, wherein the needle has a length of about 4cm from the distal end to the proximal end, and wherein the overlap region has a length of about 1 cm.

47. The robotic needle biopsy system of claim 46, wherein the robotic system is configured to advance the distal end of the needle beyond the distal end of the tubular sheath by up to 2cm in the second configuration.

48. The robotic needle biopsy system of claim 42, wherein the needle has a length between 1 and 6 centimeters.

49. The robotic needle biopsy system of claim 42, wherein the overlap region has a length of 0.5cm to 3 cm.

50. The robotic needle biopsy system of claim 42, further comprising a pressure source coupled to a proximal end of the polymer tube, wherein the robotic system is configured to provide pressure through the opening at the distal end of the needle via a channel formed by an inner surface of the polymer tube in fluid communication with the lumen of the needle.

51. The robotic needle biopsy system of claim 42, wherein the proximal end of the needle comprises a first helical channel or cut and the distal end of the tube comprises a second helical channel or cut configured to mechanically mate with the first helical channel or cut.

52. The robotic needle biopsy system of claim 42, wherein the proximal end of the needle and a distal end of the tube are secured at the overlap region by a flexible adhesive.

53. The robotic needle biopsy system of claim 42, wherein the proximal end of the needle and a distal end of the tube are secured at the overlap region by screws.

54. The robotic needle biopsy system of claim 42, the needle further comprising a plurality of surface features formed at the overlap region, wherein the polymer tube is reflowed around the surface features.

55. The robotic needle biopsy system of claim 54, wherein the plurality of surface features includes a blasted outer surface of the needle.

56. The robotic needle biopsy system of claim 54, wherein the plurality of surface features comprise laser-cut holes that each extend through a wall of the needle.

57. The robotic needle biopsy system of claim 37, wherein the needle has a wall thickness that is about 0.0015 inches thick.

58. The robotic needle biopsy system of claim 37, wherein the control system comprises a computer-readable memory storing instructions and one or more processors configured to drive the needle between the first configuration and the second configuration via the instructions.

59. The robotic needle biopsy system of claim 37, further comprising an endoscope including a working channel, wherein the sheath is positioned at least partially within the working channel.

60. The robotic needle biopsy system of claim 59, the endoscope comprising at least one actuation cable, wherein the control system is further configured to:

detecting a change in tension on the at least one actuation cable;

identifying a deflection condition at a distal tip of the endoscope caused by the needle passing through a curved portion of the working channel located near the distal tip of the endoscope; and

adjusting a tension on the at least one actuation cable to compensate for the deflection condition.

61. A medical instrument assembly comprising:

a medical instrument extending from a proximal end to a distal end and comprising a superelastic shaft formed from a superelastic alloy, the superelastic shaft extending at least partially from the distal end to the proximal end of the medical instrument;

an elongate member attached at the proximal end of the medical instrument; and

a tubular sheath comprising an internal passage, wherein:

in a first configuration, the distal end of the medical instrument is positioned within the internal passage, and

in a second configuration, the distal end of the medical device is beyond a distal end of the tubular sheath in response to distal movement of the elongate member through the internal passage.

62. The assembly according to claim 61, wherein the superelastic alloy comprises a nickel titanium alloy.

63. The assembly of claim 61, wherein the medical instrument comprises a brush at the distal end.

64. The assembly of claim 61 further comprising a radiopaque material positioned about the superelastic shaft near the distal end of the medical instrument.

65. The assembly of claim 64, wherein the radiopaque material comprises a gold band.

66. The assembly of claim 64, wherein the radiopaque material has a thickness of at least 200 microinches.

67. The assembly according to claim 61, wherein said elongate member comprises a polymer tube reflowed about an overlap region at said proximal end of said superelastic shaft.

68. The assembly of claim 67, wherein the polymer tube includes a tapered section at a distal end of the polymer tube before or after being reflowed about the overlap region.

69. The assembly of claim 67, wherein the polymer tube comprises a flexible thermoplastic.

70. The assembly according to claim 67, wherein the superelastic shaft has a length of about 5 centimeters from the distal end to the proximal end, and wherein the overlap region has a length of about 2 centimeters.

71. The assembly according to claim 67, wherein the superelastic shaft has a length of about 4 centimeters from the distal end to the proximal end, and wherein the overlap region has a length of about 1 centimeter.

72. The assembly according to claim 67, wherein the superelastic shaft has a length between 1 centimeter and 6 centimeters.

73. The assembly of claim 67, wherein the overlap region has a length of 0.5cm to 3 cm.

74. The assembly of claim 67 further comprising a plurality of surface features formed on the superelastic shaft at the overlap region, wherein the polymer tube is reflowed about the surface features.

75. The assembly according to claim 74, wherein the plurality of surface features includes a blasted outer surface of the superelastic shaft.

76. The assembly according to claim 74, wherein the plurality of surface features includes laser-cut holes that each extend through a wall of the superelastic shaft.

77. The assembly according to claim 61, wherein the superelastic shaft is tubular.

78. The assembly according to claim 61, wherein said elongate member comprises a polymer tube secured about an overlap region at said proximal end of said superelastic shaft and a distal end of said tube.

79. The assembly according to claim 78, wherein the proximal end of the superelastic shaft includes a first helical channel or cut and the distal end of the tube includes a second helical channel or cut configured to mechanically mate with the first helical channel or cut.

80. The assembly according to claim 78, wherein the proximal end of the superelastic shaft and the distal end of the tube are secured at the overlap region by a flexible adhesive.

81. The assembly according to claim 78, wherein the proximal end of the superelastic shaft and the distal end of the tube are fastened at the overlap region by screws.

82. A medical device, comprising:

a medical instrument extending from a proximal end to a distal end and comprising a superelastic shaft formed from a superelastic alloy, the superelastic shaft extending at least partially from the distal end to the proximal end of the medical instrument;

an elongate member attached at the proximal end of the medical instrument;

a tubular sheath comprising an internal passage, wherein:

in a first configuration, the distal end of the medical instrument is positioned within the internal passage, and

in a second configuration, the distal end of the medical instrument is beyond a distal end of the tubular sheath in response to distal movement of the elongate member through the internal channel; and

a handle, the handle comprising:

a distal end coupled to a proximal end of the sheath,

an inner drive member coupled to a proximal end of the elongate member,

a movable grip portion, and

at least one motion transfer interface configured to actuate the distal movement of the elongate member through the internal channel in response to user movement of the movable grip.

83. The device of claim 82 wherein the superelastic alloy comprises a nickel titanium alloy.

84. The device of claim 82, wherein the medical instrument comprises a brush at the distal end.

85. The device of claim 82, wherein the medical instrument comprises a needle including an inner surface forming a lumen extending through a body portion of the needle from an opening in a proximal end of the needle to an opening in a distal end of the needle, wherein the lumen and the opening in the distal end are configured to obtain a tissue biopsy.

Technical Field

The present disclosure relates generally to medical devices and more particularly to superelastic medical instruments.

Background

Endoscopy (e.g., bronchoscopy) may involve accessing and visualizing the interior of a patient's luminal network for diagnostic and/or therapeutic purposes. During surgery, a flexible tubular tool, referred to as an endoscope, may be inserted into a patient's body, and the tool may be passed down the endoscope to an identified tissue site for subsequent diagnosis and/or treatment. The endoscope may have a lumen (e.g., a "working channel") that provides access to the tissue site, and a catheter and/or various medical tools may be inserted through the working channel to the tissue site.

Disclosure of Invention

The systems, methods, and devices of the present disclosure each have several innovative aspects, none of which is solely responsible for the desirable attributes disclosed herein.

Accordingly, one aspect relates to a biopsy needle assembly comprising: a needle formed from a superelastic alloy, the needle including a body portion extending from a distal end of the needle to a proximal end of the needle, and an inner surface of the needle forming a lumen extending through at least a portion of the body portion to an opening in the distal end, wherein the lumen and the opening are configured to obtain a tissue biopsy; an elongate shaft attached at a proximal end of the needle; and a tubular sheath comprising an internal passage, wherein in a first configuration the distal end of the needle is positioned within the internal passage and in a second configuration the distal end of the needle extends beyond the distal end of the tubular sheath in response to distal movement of the elongate shaft through the internal passage.

In some embodiments, the superelastic alloy comprises a nickel titanium alloy. In some embodiments, the needle has a wall thickness of about 0.0015 inches thick.

Some embodiments further comprise a sharp tip at the distal end of the needle. Some embodiments further include a radiopaque material positioned around the needle near the sharp tip. In some embodiments, the radiopaque material comprises gold. In some embodiments, the radiopaque material has a thickness of at least 200 microinches.

In some embodiments, the elongate shaft comprises a polymer tube reflowed about an overlap region at the proximal end of the needle. In some embodiments, the polymeric tube includes a tapered section at its distal end before or after being reflowed about the overlap region. In some embodiments, the polymeric tube comprises a flexible thermoplastic. In some embodiments, the length of the needle from the distal end to the proximal end is about 5 centimeters, and wherein the length of the overlap region is about 2 centimeters. In some embodiments, the length of the needle from the distal end to the proximal end is about 4 centimeters, and wherein the length of the overlap region is about 1 centimeter. In some embodiments, the length of the needle is between 1 and 6 centimeters. In some embodiments, the length of the overlap region is from 0.5cm to 3 cm. In some embodiments, the channel formed by the inner surface of the polymer tube is in fluid communication with the lumen to provide pressure through the opening.

In some embodiments, the elongate shaft includes a polymer tube reflowed about an overlap region at the proximal end of the needle, and the assembly further includes a plurality of surface features formed on the needle at the overlap region, wherein the polymer tube is reflowed about the surface features. In some embodiments, the plurality of surface features comprises a blasted outer surface of the needle. In some embodiments, the plurality of surface features comprise laser-cut holes that each extend through a wall of the needle. In some embodiments, the overlap region is located at the distal end of the tube. In some embodiments, the proximal end of the needle comprises a first helical channel or cut and the distal end of the tube comprises a second helical channel or cut configured to mechanically mate with the first helical channel or cut. In some embodiments, the proximal end of the needle and the distal end of the tube are secured at the overlap region by a flexible adhesive. In some embodiments, the proximal end of the needle and the distal end of the tube are fastened at the overlap region by screws.

In some embodiments, the superelastic alloy has the following original shape in its austenite phase: in this original shape, the body portion is straight. In some embodiments, the superelastic alloy is reversibly deformable up to 10% in its martensite phase relative to its original shape.

Another aspect relates to a method of obtaining a tissue biopsy, the method comprising: positioning a distal end of a working channel of an endoscope adjacent to a desired biopsy site; advancing a tubular sheath through the working channel, the sheath comprising a biopsy needle assembly positioned within the sheath, the biopsy needle assembly comprising a needle formed from a superelastic alloy and an elongate shaft, the needle comprising a body portion extending from a distal end of the needle to a proximal end of the needle and an inner surface of the needle forming a lumen extending through at least a portion of the body portion to an opening in the distal end, wherein the lumen and the opening are configured to obtain a tissue biopsy, the elongate shaft being attached at the proximal end of the needle; actuating a first linear movement of the proximal end of the elongate shaft to drive at least a portion of the needle out of the sheath into the biopsy site; obtaining a tissue sample from the biopsy site through the opening of the needle; and actuating a second linear movement of the proximal end of the elongate shaft to drive the needle to retract from the biopsy site.

Some embodiments further comprise: pressure is applied within the lumen to obtain a tissue biopsy. In some embodiments, the sheath has a handle coupled to a proximal end of the sheath, the sheath configured to actuate first and second linear motions of the proximal end of the elongate shaft along a longitudinal axis of the handle, the method further comprising actuating the handle to control extension and retraction of the needle. Some embodiments further comprise robotically controlling actuation of the handle.

In some embodiments, the elongate shaft comprises a polymeric tube secured at an overlap region at the proximal end of the needle, and the method further comprises positioning the distal end of the sheath a predetermined distance from the tissue site, the predetermined distance being less than a length of the needle that extends distally beyond the overlap region, and wherein actuating the first linear motion comprises: performing a first actuation of the needle to extend the needle out of the sheath; determining that the distal end of the needle is positioned outside the sheath; and performing a second actuation of the needle to extend the needle into the biopsy site. Some embodiments further comprise: it is determined that the overlap region remains at least partially positioned within the sheath after the first actuation and before the second actuation. Some embodiments further comprise: it is determined that the overlap region remains positioned at least partially within the working channel of the endoscope after the first actuation and before the second actuation. In some embodiments, performing the second drive comprises: extending the needle into the biopsy site and retracting the needle from the biopsy site alternate multiple times.

Some embodiments further comprise: visualizing the biopsy site using fluoroscopy; and determining that the distal end of the needle is positioned at the biopsy site by observing, via fluoroscopy, radiopaque material positioned about the needle near the distal end.

In some embodiments, advancing the tubular sheath through the working channel comprises: advancing a needle through the curved portion of the working channel; and advancing the needle through the curved portion reversibly deforms the needle up to 10% from an original shape of the needle in which the body portion is straight. In some embodiments, reversibly deforming the needle comprises: the superelastic alloy is transformed from the austenite phase, in which the needle assumes its original shape, to the martensite phase. In some embodiments, driving the at least a portion of the needle out of the sheath into the biopsy site comprises: automatically converting the at least a portion of the needle back to the austenitic phase and returning to the original shape.

Another aspect relates to a robotic needle biopsy system comprising: a needle formed from a superelastic material, the needle including an inner surface forming a lumen extending through a body portion of the needle from an opening in a proximal end of the needle to an opening in a distal end of the needle, wherein the lumen and the opening in the distal end are configured to obtain a tissue biopsy; an elongate shaft secured at the proximal end of the needle; a tubular sheath comprising an internal passage positioned about the needle and at least a portion of the elongate shaft; and a control system configured to move the elongate shaft to drive the needle between a first configuration and a second configuration, wherein in the first configuration the distal end of the needle is positioned within the interior passage of the tubular sheath, and wherein in the second configuration the distal end of the needle extends beyond the distal end of the tubular sheath.

In some embodiments, the needle further comprises a sharp tip at the distal end of the needle. In some embodiments, the needle further comprises a radiopaque material positioned about the body portion of the needle near the sharp tip. In some embodiments, the radiopaque material comprises a gold pattern. In some embodiments, the radiopaque material has a thickness in the range of from about 200 microinches to about 1000 microinches.

In some embodiments, the elongate shaft comprises a polymeric tube secured around an overlap region at the proximal end of the needle. In some embodiments, the polymeric tube comprises a flexible thermoplastic that is reflowed around the overlap region. In some embodiments, the needle has a length of about 5cm from the distal end to the proximal end, and wherein the overlap region has a length of about 2 cm. In some embodiments, the robotic system is configured to: in the second configuration, the distal end of the needle is advanced up to 3cm beyond the distal end of the tubular sheath. In some embodiments, the needle has a length of about 4cm from the distal end to the proximal end, and wherein the overlap region has a length of about 1 cm. In some embodiments, the robotic system is configured to: in the second configuration, the distal end of the needle is advanced up to 2cm beyond the distal end of the tubular sheath. In some embodiments, the needle has a length between 1 centimeter and 6 centimeters. In some embodiments, the overlap region has a length of 0.5cm to 3 cm. In some embodiments, the robotic needle biopsy system further comprises a pressure source coupled to the proximal end of the polymeric tube, and the robotic system is configured to provide pressure through the opening at the distal end of the needle via the channel formed by the inner surface of the polymeric tube in fluid communication with the lumen of the needle.

In some embodiments, the elongate shaft comprises a polymeric tube secured around an overlap region at the proximal end of the needle, and the proximal end of the needle comprises a first helical channel or cut, and the distal end of the tube comprises a second helical channel or cut configured to mechanically mate with the first helical channel or cut. In some embodiments, instead of or in addition to the mechanical fit, the proximal end of the needle and the distal end of the tube are secured at the overlap region by a flexible adhesive. In some embodiments, in addition to being mechanically fitted via a helical channel and/or secured by adhesive, the proximal end of the needle and the distal end of the tube are also secured at the overlap region by a screw.

In some embodiments, the elongate shaft includes a polymer tube secured around an overlap region at the proximal end of the needle, and the needle further includes a plurality of surface features formed at the overlap region, wherein the polymer tube is reflowed around the surface features. In some embodiments, the plurality of surface features comprises a blasted outer surface of the needle. In some embodiments, the plurality of surface features comprise laser-cut holes that each extend through a wall of the needle.

In some embodiments, the needle has a wall thickness of about 0.0015 inches thick. In some embodiments, a control system includes a computer-readable memory storing instructions and one or more processors configured to drive a needle between a first configuration and a second configuration via the instructions.

Some embodiments further comprise an endoscope comprising a working channel, wherein the sheath is positioned at least partially within the working channel. In some embodiments, the endoscope comprises at least one actuation cable, wherein the control system is further configured to: detecting a change in tension on the at least one actuation cable; identifying a deflection condition at the distal tip of the endoscope resulting from the needle passing through a curved portion of the working channel located near the distal tip of the endoscope; and adjusting tension on the at least one actuation cable to compensate for the deflection condition.

Another aspect relates to a medical instrument assembly, comprising: a medical device extending from a proximal end to a distal end and comprising a superelastic shaft formed from a superelastic alloy, the superelastic shaft extending at least partially from the distal end to the proximal end of the medical device; an elongate shaft attached at a proximal end of the medical device; and a tubular sheath comprising an internal passage, wherein in a first configuration, a distal end of the medical device is positioned within the internal passage, and in a second configuration, the distal end of the medical device is beyond the distal end of the tubular sheath in response to the elongate shaft moving through the distal end of the internal passage.

In some embodiments, the superelastic alloy comprises a nickel titanium alloy. In some embodiments, the medical instrument includes a brush at the distal end.

Some embodiments further comprise a radiopaque material positioned about the superelastic shaft near the distal end of the medical device. In some embodiments, the radiopaque material comprises a gold band. In some embodiments, the radiopaque material has a thickness of at least 200 microinches.

In some embodiments, the elongate shaft comprises a polymer tube reflowed about an overlap region at the proximal end of the superelastic shaft. In some embodiments, the polymeric tube includes a tapered section at its distal end before or after being reflowed about the overlap region. In some embodiments, the polymeric tube comprises a flexible thermoplastic. In some embodiments, the superelastic shaft has a length from the distal end to the proximal end of about 5 centimeters, and wherein the overlap region has a length of about 2 centimeters. In some embodiments, the superelastic shaft has a length of about 4 centimeters from the distal end to the proximal end, and wherein the overlap region has a length of about 1 centimeter. In some embodiments, the superelastic shaft has a length between 1 centimeter and 6 centimeters. In some embodiments, the overlap region has a length of 0.5cm to 3 cm.

In some embodiments, the elongate shaft comprises a polymer tube reflowed about an overlap region at the proximal end of the superelastic shaft. In some embodiments, the elongate shaft includes a polymer tube reflowed about an overlap region at a proximal end of the superelastic shaft, and the superelastic shaft further includes a plurality of surface features formed on the superelastic shaft at the overlap region, wherein the polymer tube is reflowed about the surface features. In some embodiments, the plurality of surface features comprises a blasted outer surface of the superelastic shaft. In some embodiments, the plurality of surface features comprise laser-cut holes that each extend through a wall of the superelastic shaft.

In some embodiments, the superelastic shaft is tubular. In some embodiments, the elongate shaft comprises a polymeric tube secured around an overlap region at the proximal end of the superelastic shaft and the distal end of the tube. In some embodiments, the proximal end of the superelastic shaft includes a first helical channel or cut, and the distal end of the tube includes a second helical channel or cut configured to mechanically mate with the first helical channel or cut. In some embodiments, the proximal end of the superelastic shaft and the distal end of the tube are secured at the overlap region by a flexible adhesive. In some embodiments, the proximal end of the superelastic shaft and the distal end of the tube are fastened at the overlap region by screws.

Another aspect relates to a medical device comprising: a medical device extending from a proximal end to a distal end and comprising a superelastic shaft formed from a superelastic alloy, the superelastic shaft extending at least partially from the distal end to the proximal end of the medical device; an elongate shaft attached at a proximal end of the medical device; a tubular sheath including an internal passage, wherein in a first configuration, a distal end of the medical device is positioned within the internal passage, and in a second configuration, the distal end of the medical device is beyond the distal end of the tubular sheath in response to the elongate shaft moving through the distal end of the internal passage; and a handle including a distal end coupled to the proximal end of the sheath, an inner drive member coupled to the proximal end of the elongate shaft, a movable grip, and at least one motion transfer interface configured to actuate distal motion of the elongate shaft through the inner channel in response to user motion of the movable grip.

In some embodiments, the superelastic alloy comprises a nickel titanium alloy. In some embodiments, the medical instrument includes a brush at the distal end. In some embodiments, a medical instrument includes a needle including an inner surface forming a lumen extending through a body portion of the needle from an opening in a proximal end of the needle to an opening in a distal end of the needle, wherein the lumen and the opening in the distal end are configured to obtain a tissue biopsy.

Drawings

The disclosed aspects will hereinafter be described in conjunction with the appended drawings and appendices, which are provided to illustrate and not to limit the disclosed aspects, wherein like numerals denote like elements.

Fig. 1A and 1B illustrate embodiments of superelastic needles as described herein.

Fig. 2A-2C illustrate various configurations of a needle assembly as described herein.

Fig. 3A and 3B illustrate the needle assembly of fig. 2A-2C exhibiting superelastic characteristics in the retracted and extended configurations.

FIG. 3C depicts a cross-sectional view of the speculum, sheath, tube and needle of FIGS. 3A and 3B.

FIG. 4A illustrates an example offset angle comparison between the speculum axes before and after a superelastic needle is passed through the speculum.

FIG. 4B illustrates a comparison of the deflection angle between the disclosed superelastic needle and a conventional needle deployed the same distance outside of a scope.

FIG. 5 illustrates an embodiment of a needle assembly including an example steering handle as described herein.

Fig. 6 depicts a schematic view of a robotic surgical system for actuating a needle as described herein.

Fig. 7 depicts a flow diagram of an embodiment of a method for obtaining a tissue sample with a needle as described herein.

Detailed Description

Brief introduction to the drawings

A medical procedure may involve the manipulation of a tool that is positioned away from an operator, e.g., through a channel (e.g., trocar, catheter, endoscope, etc.) inserted into a patient. As one example of such a procedure, transbronchial needle biopsy (TBNA) may be used as a minimally invasive bronchoscopy technique for the diagnosis and staging of bronchial diseases, including lung cancer. TBNA techniques may involve manipulating a biopsy needle through a flexible bronchoscope. For example, a physician may use a chest scan to identify the location of a tumor to be biopsied and direct the positioning of a bronchoscope within the patient's airway toward the tumor. After the distal end of the working channel of the bronchoscope is positioned near the identified tumor within the airway, an elongated tubular sheath containing a biopsy needle may be advanced through the working channel to the sampling region. The target tissue may then be penetrated by extending the needle out of the sheath, and suction may be applied to assist in sample acquisition. Typically, sample acquisition involves: the tube is moved back and forth relative to the bronchoscope to repeatedly pierce the tissue site with the needle (referred to as "whipping"). After sample acquisition, the needle may be retracted into the sheath and withdrawn through the working channel. In some procedures, sample analysis may be performed in the same area and/or concurrently as a TBNA procedure, and other tissue sampling and/or processing may be performed as a result of further analysis of TBNA sample acquisition.

Bronchoscopy techniques, including TBNA, can involve the challenge of accessing masses located at the periphery of the lungs, particularly where such masses are relatively small, e.g., about 8mm or less. Sampling of masses at the peri-lung site presents challenges in diagnosing and staging cancerous masses, particularly in the early cancer stages, which are the following time periods: during this period of time, such masses may be more easily treated and may not spread to other locations within the patient's body. For example, a challenge in utilizing a needle with a flexible bronchoscope is that the needle should be flexible enough to be able to maneuver through the tortuous path of the bronchoscope to the target tissue site while still being rigid enough to deploy in a straight line and allow penetration of the target tissue, and a challenge in utilizing a needle with a flexible bronchoscope is that the needle preferably deploy along a straight line trajectory over a range of distances sufficient to reach around the lung.

With respect to flexibility, bronchoscopes have a smaller and smaller radius of curvature available to them to allow the bronchoscope to navigate through the patient's airway. With respect to stiffness, bronchial walls or tumor tissue may exhibit a significant ability to resist needle penetration. Some previous approaches have used a short and rigid needle at the distal end of the plastic sheath to meet these requirements so that the needle does not have to bend too much as it is advanced through the bronchoscope. One example of an existing needle is a rigid needle having a length of about 7mm or less (see, e.g., needle 450 in fig. 4B). However, the use of such relatively short needles limits the extent to which the needle can be deployed in a straight line — that is, limits the ability of the needle to extend from the working channel with the proximal end still secured within the working channel. This may limit the extent of the needle, preventing sampling of tissue at or near the periphery of the lung. Furthermore, if the sheath is stuck in the tissue, the sheath cannot pierce the tissue and thus cause trauma to the patient tissue, thus deflecting the tissue to allow deeper penetration by the needle.

In addition, the above challenges are addressed in some embodiments by the superelastic needle assemblies described herein. Embodiments of the present disclosure relate to superelastic needles, and in particular to the following needles: the needle is preformed into a shape (e.g., straight or curved) and is capable of being elastically bent through the tortuous path of a bronchoscope, reverting to the preformed shape upon deployment from the bronchoscope, and being deployed along the axis of the end of the bronchoscope (within a range of permissible margins) with improved reach (e.g., in some embodiments, improved reach up to 2cm or more distance). The disclosed superelastic needle is configured for increased stability and accuracy during deployment by retaining an overlap between a proximal portion of the needle, a distal end of the scope used to deliver the needle, and a distal end of the sheath housing the needle within the scope. The increased length of the disclosed needle allows for this overlap while achieving the desired amount of reach, and the disclosed superelastic alloy enables the increased needle length to pass through the curvature of the speculum. In addition, the disclosed needle reduces speculum tip deflection at the tip of the speculum during needle delivery through the working channel, which provides the desired accuracy of tissue sampling. In addition, the disclosed needles have aspiration/negative and/or positive pressure capabilities by having an open lumen. Thus, the disclosed needle may provide an enhancement in the ability to sample tissue at the periphery of the lung, e.g., a smaller lesion. Advantageously, this may allow the physician to diagnose and stage smaller peri-lung cancerous masses at an early stage.

The disclosed systems and techniques may provide advantages for needle biopsy of bronchoscopes and other applications, including manipulation of other endoscopic, laparoscopic, and/or catheter-delivering tools. For example, superelastic shafts similar to the disclosed needles may be provided for other types of medical tools, such as augers, cytological brushes, and/or forceps. It will be appreciated that the needle dimensions described below may be similarly applied to the dimensions of the superelastic shaft, and that the superelastic shaft may or may not be formed as a tubular shaft having an internal lumen. Thus, although the disclosed superelastic shaft is described below in the sections of the present disclosure in the context of a bronchoscope biopsy needle, it should be understood that such a shaft may also be used with other endoscopic tools and in other types of procedures to provide the disclosed benefits. For example, the superelastic medical tools described herein may be used in other types of procedures including laparoscopy, gastrointestinal endoscopy, urethroscopy, cardioscopy, and may be used in other procedures where tools are delivered through flexible and/or curved scopes, catheters or tubes (scopes, catheters, or tubes are collectively referred to as endoscopes to simplify the description of the various embodiments discussed herein).

As used herein, the term "superelasticity" generally refers to the following mechanical type of shape memory: in this mechanical type of shape memory, the elasticity (reversibility) in response to an applied stress is caused by a solid-solid phase change. In some cases, the superelastic effect is induced when a crystalline material in the austenitic state is mechanically loaded up to a critical stress and within a specific temperature range above the martensitic phase transition final temperature, where a phase transition to the martensitic phase is induced. When subjected to such mechanical loading, the superelastic material can be reversibly deformed to very high strains (e.g., where the nickel-titanium alloy is up to 10%) through the formation of such stress-producing phases. When the load is removed, the martensite phase becomes unstable and the material undergoes a reverse deformation to recover its original shape. Furthermore, the material does not require a temperature change to undergo such reverse deformation and to recover the original shape. Nitinol is a metallic alloy of nickel and titanium that has superelastic properties in a temperature range around room temperature. Other examples of superelastic materials include alloys of nickel and titanium with other elements (Ni-Ti-Fe, Ni-Ti-Cr, Ni-Ti-Cu-Cr), some polycrystalline iron alloys (e.g., Fe-Ni-Co-Al-Ta-B and Fe-Mn-Al-Ni), Cu-Al-Mn (CAM) alloys, and Cu-Zn-Sn alloys. It should be understood that although the disclosed superelastic materials may be discussed herein with respect to embodiments as needles formed and returned to a straight shape, it will be understood that medical tools formed from the disclosed superelastic materials may be formed to return to a curved, angled or other non-linear shape in other embodiments.

As used herein, strain generally refers to the amount of deformation an object undergoes compared to its original size and shape, and strain may be expressed as a percentage.

As used herein, "distal end" refers to the end of the scope or tool that is positioned closest to the patient tissue site during use, and "proximal end" refers to the end of the sheath or tool that is positioned closest to the operator (e.g., physician or robotic control system). In other words, the relative positions of the sheath, needle, and/or components of the robotic system are described herein from the vantage point of the operator.

As used herein, the term "jitter" refers to the back and forth motion of a medical instrument, such as a biopsy needle, for example, during tissue sampling. The whipping motion of the needle may be independent of the motion of the sheath of the needle such that the sheath of the needle remains relatively stationary during whipping.

As used herein, the term "about" refers to a measurement range of length, thickness, number, time period, or other measurable value. Such measurement ranges encompass variations of, and from, a particular value of ± 10% or less, preferably ± 5% or less, more preferably ± 1% or less, and still more preferably ± 0.1% or less, so long as such variations are appropriate to function in the disclosed devices, systems, and techniques.

Robotic surgical systems may robotically perform minimally invasive endoscopic procedures with endoscopic instruments. Accordingly, some embodiments of the present disclosure are directed to surgical instruments and systems that include a superelastic needle: the superelastic needle may be advantageously used in a robotic-guided (whether a fully automated robotic system or a robotic system providing some degree of assistance) medical procedure, and in a method of performing a medical procedure under the direction of a robotic surgical system. In such systems, the robotic arm may be configured to control the extension, whipping, and/or retraction of the needle as described herein. The drive signals for such actuation may be provided by the robotic surgical system, for example, in response to user input through an input device and/or a computer-controlled surgical procedure.

Various embodiments are described below in conjunction with the appended drawings for purposes of illustration. It should be understood that many other embodiments of the disclosed concept are possible and that various advantages can be achieved with the disclosed embodiments. Headings are included herein for reference and to aid in locating various parts. These headings are not intended to limit the scope of the concepts described with respect to these headings. Such concepts may have applicability throughout the present specification.

Overview of an exemplary needle assembly

Fig. 1A and 1B illustrate an embodiment of a superelastic needle 120 as described herein. FIG. 1A shows two components of a needle assembly 100: a superelastic needle 120 and an elongate shaft 110 coupled to the needle 120.

The needle 120 is formed as a thin-walled tube. In some embodiments, the needle 120 is capable of transmitting negative (or positive) pressure through a lumen (not shown) extending through the body of the needle 120 from a first aperture 121 at the proximal end of the body of the needle 120 to a second aperture 124 at the distal end 125 of the needle 124. In some embodiments, the wall thickness of the needle is about 0.0015 inches. This thin wall may increase the flexibility of the needle and also advantageously increase the inner diameter of the needle to collect a greater amount of biopsy material. In some embodiments, the outer diameter of the needle may be as high as 0.023 inches, as for larger diameters the walls may need to be unrealistically thin to maintain the desired flexibility. A smaller outer diameter may make the wall thicker, however the lumen of such a needle will be able to collect less material. It should be understood that these measurements are provided to possible embodiments and do not limit the scope of other embodiments contemplated by the present disclosure.

In some embodiments, the needle 120 may be formed of a nickel titanium alloy, but in other embodiments, one or more other suitable superelastic materials may be used. Nitinol is a nickel-titanium alloy having approximately equal atomic percentages of nickel and titanium, e.g., a ratio of nickel to titanium between 0.92 and 1.06. In some embodiments formed from nitinol, the superelastic material of the needle 120 may assume an interpenetrating simple cubic configuration (referred to as the austenite phase) and may be set in this phase to the straight tubular shape shown in fig. 1A. When a nickel-titanium alloy in the austenitic phase is subjected to an external force in a temperature range from about-20 ℃ to +60 ℃, the nickel-titanium alloy undergoes a phase transformation to the martensitic phase and a shape change (e.g., bending along the longitudinal axis of the nickel-titanium alloy as the nickel-titanium alloy travels through a bronchoscope). In the martensite phase, the crystal structure of the nickel titanium alloy is transformed into a monoclinic structure, thereby imparting the ability of the nickel titanium alloy to undergo twinning (e.g., rearrangement of atomic planes without causing sliding or permanent deformation) without breaking atomic bonds. Nitinol can reversibly withstand strains of up to 10% in this manner. After this strain is released, the nickel titanium alloy will automatically return to the austenite phase and original shape. In contrast to shape memory nitinol, in superelastic nitinol, this inversion occurs without any temperature change.

In other embodiments, the needle 120 may be formed using one or more other suitable superelastic materials capable of an austenite-martensite solid-solid phase transformation. As described above, such materials include nickel and titanium other alloys with other elements (Ni-Ti-Fe, Ni-Ti-Cr, Ni-Ti-Cu-Cr), some polycrystalline iron alloys (e.g., Fe-Ni-Co-Al-Ta-B and Fe-Mn-Al-Ni), Cu-Al-Mn (CAM) alloys, and Cu-Zn-Sn alloys. Thus, the needle 120 may be formed of a superelastic material having the following characteristics: (1) a first solid crystal structure set to a straight tubular shape in an austenite phase of the superelastic material; (2) a second solid crystal structure in the martensite phase of the superelastic material that allows the tubular shape to elastically deform (e.g., bend) up to a threshold strain percentage; and (3) the ability to automatically revert from the martensite phase to the austenite phase (and thus to the original straight tubular shape) upon release of strain without any temperature change.

The elongate shaft 110 may be formed as a tube having an aperture 104 at its proximal end 102, the aperture 104 leading to a lumen 106, the lumen 106 being in fluid communication with the lumen of the needle 120. An inspiratory or positive pressure may be applied through the port 104 and delivered through the distal port 124 of the needle 120. The elongate shaft 110 may be a flexible thermoplastic polymer, such as a flexible polymeric single chamber extrusion formed from HDPE (high density polyethylene). Other flexible thermoplastics may be used in other embodiments, either alone or in mixed or layered combinations. For example, multiple polymers may be reflowed together to create the following tubes: the tube is stiffer at one end and more flexible at the other end. In some embodiments, the elongate shaft 110 may be formed from braided wire that has heat shrink to provide some twisting capability to the wire.

The elongate shaft 110 is secured to the needle 120 at the overlap region 130. In some embodiments, this may be a fluid-tight (e.g., air-tight and liquid-tight) connection. To secure the elongate shaft 110 to the needle 120, in some examples, the elongate shaft 110 may be reflowed about the needle 120 at the overlap region 130. For example, a mandrel may be placed within the lumen of the needle 120 and the lumen 106 of the elongate shaft 110, and the elongate shaft 110 may be positioned about the needle 120 in the overlap region 130. The mandrel can help ensure that the inner cavity is not blocked during the reflow process. Heat shrink may be positioned about elongate shaft 110 and needle 120 at least at overlap region 130 and heat applied to melt the material of elongate shaft 110, thereby causing elongate shaft 110 to reflow about and bond to the outer surface of needle 120. The outer surface of the needle 120 may have surface features along some or all of this overlap region 130, such as a sandblasted or frosted surface, laser cut etchings or through holes, or surface etchings or holes formed by other drilling and/or cutting techniques to promote better adhesion. In some embodiments, the polymeric elongate shaft 110 may have a tapered shape at its distal end before and/or after reflow soldering. The tapered shape may provide a ramped or smooth transition from the needle to the tube.

In other embodiments, the elongate shaft 110 and the needle 120 may be bonded in other ways instead of or in addition to the reflow soldering described above. For example, the walls of the needle 120 may be provided with etched, molded, or cut features (e.g., barbs, helical channels, etc.), and the proximal end of the elongate shaft 110 may be etched, molded, or cut with corresponding features that mate with and lock into the barbs in the needle 120. As another example, the elongate shaft 110 may have additional cavities within a portion of the wall, and barbs extending from the needle 120 may be positioned within these additional cavities and secured via adhesive, mechanical mating elements, and/or reflow soldering. In other examples, mechanical fasteners (e.g., pins, screws, etc.) or flexible adhesives (e.g., silicone adhesives) may be used to couple the elongate shaft 110 and the needle 120. Further, in some embodiments, the elongate shaft 110 may be directly connected to the proximal end of the needle such that no overlap region is included. Other methods may use a sheet bonding method in which two heated boards are subjected to reflow soldering.

In one example design, it is desirable that the needle 120 be capable of linear deployment across a distance of at least 3 cm. For example, the range of scopes that may be used with the needle 120 may be difficult to reach to the nodule because some endoscopes may reach within 3cm of most areas of the lung. Furthermore, reaching this length will provide the practitioner with different options for how to position the endoscope to obtain a biopsy. Thus, in some embodiments, the needle may have a length of at least 3 cm. In other embodiments, the needle may be longer, for example 5cm to 6cm, in order to provide an "anchoring" portion that remains within the scope during extension of distal tip 125 up to 3 cm. This may advantageously provide stability for linear deployment of the needle to the target tissue site. Thus, in various embodiments, the overlap region 130 can be 2cm to 3cm long and the overlap region 130 can form an anchoring portion intended to remain within a working channel of an endoscope, and the portion of the needle 120 that extends distally beyond the overlap region 120 can be about 3cm to 4cm long.

Some endoscopic procedures may involve the use of fluoroscopy to assist in the navigation of medical instruments through a luminal network of a patient. In fluoroscopy, the x-ray radiation source is arranged to pass an x-ray beam through the patient's tissue. The beam may be received by a screen positioned on the other side of the patient from the x-ray radiation source, and the resulting signals may be used to generate an image (e.g., an image in grayscale or pseudo-color) to delineate the internal structures of the patient. Radiopacity refers to the relative ability of electromagnetic radiation, particularly x-rays, to fail to pass through a particular material. Materials that block x-ray photons from passing through are referred to as radiopaque, while materials that allow radiation to pass more freely are referred to as radiolucent or radiolucent. As used herein, the term "radiopaque" generally refers to a relatively opaque white appearance of a dense material as compared to the relatively darker appearance of a less dense material as observed in radiographic imaging. Nitinol and some other superelastic materials may be radiolucent or radiolucent, making these materials invisible or nearly invisible in x-ray photographs or under fluoroscopy. This may make it difficult to navigate the needle 120 through the patient when using a fluoroscopy-based navigation system.

Thus, some embodiments of needle 120 may be provided with radiopaque material 123 near the sharp tip and distal end 125. In some examples, radiopaque material 123 may be positioned approximately 3mm away from the distal tip of needle 120. As described above, radiopaque materials are opaque to x-ray radiation and thus visible in x-ray photographs and under fluoroscopy. Thus, while the material of the needle 120 may be radiolucent, navigation of the needle 120 may be guided by observing the position of the radiopaque material 123. Disposing radiopaque material 123 near distal end 125 (or as close as possible to distal end 125, which is referred to as a tapered or sharp tip) may beneficially provide an indication of how close distal end 125 is to the target tissue site.

In one example, the radiopaque material 123 may be formed as a thin gold band and secured around the outer surface of the needle 120. In general, elements with high atomic numbers have high radiopacity, and thus the radiopacity of materials increases with increasing particle ratio of those materials having an element composition with a high atomic number. Other embodiments may utilize the following suitable radiopaque materials: the radiopaque material has a high elemental composition of elements with high atomic numbers, including tungsten, noble metals and noble metal-containing alloys, including chromium-nickel alloys (Cr-Ni), radiopaque ceramics, and radiopaque thermoplastics. In some embodiments, radiopaque material 123 may be formed as several blades to increase flexibility. Preferably, the selected radiopaque materials are sterilizable and non-toxic to human tissue. It will be appreciated that other shapes and locations other than the illustrated bands may be used for radiopaque material 123, such as by providing surface etchings or holes in needle 120 and filling such etchings or holes with radiopaque material 123. In other embodiments, radiopaque material 123 may be secured to the interior of needle 120.

As shown in fig. 1B, the needle 120 is formed with a sharp tip 140 at its distal end 125. The sharp tip 140 includes the following lancet design: in this lancet design, one section 144 is ground flat at a first angle and the second section 142 is ground flat at a different angle. The second region 142 provides a straight slope for the end of the sharp tip 140 that meets the outer diameter of the needle 120. The diameter of the needle 120 is again increased at the location of the radiopaque material 123.

As a first force, F_iReflecting the initial penetration force required to drive the tip of the needle 120 into the patient's tissue. This force may increase along the area of the sharp tip 140, thereby reaching a peak penetration force F at the outer diameter of the needle 120_p. The penetration force F to the neck passage force may occur when the leading edge of radiopaque material 123 is inserted into tissue_cAnother increase in (c).

It will be appreciated that the thickness of the radiopaque material 123 has an effect on both the radiopacity and the increase in penetration force required to insert the increased thickness into the patient's tissue. In various embodiments utilizing gold tape, the thickness of the walls of the gold tape may be in the range of 500 μ in (microinches) to 1000 μ in to achieve a desired balance between these factors. Some embodiments may utilize radiopaque material 123 having a thickness of at least 200 μ in.

Fig. 2A-2C illustrate various configurations of a needle assembly 200 as described herein. The needle assembly 200 includes a needle 220, a shaft 210 coupled to the needle 220 at an overlap region 215, and a sheath 225. The needle 220 and shaft 210 may be the needle 120 and elongate shaft 110 discussed above with respect to fig. 1. As depicted, needle 220 includes radiopaque material 230 secured near distal tip 240. In some embodiments, the sheath 225 may be a polymeric catheter or tube, and in other embodiments, the sheath 225 may be a steerable channel. The outer diameter of the sheath 225 can be selected to substantially match the inner diameter of the working channel of the scope to securely center the needle 220 relative to the working channel. Sheath 225 may include a band of radiopaque material at or near its distal tip.

Fig. 2A illustrates the needle assembly 200 in a retracted configuration 205A. In the retracted configuration 205A, the distal end 240 of the needle 220 is positioned at or near the distal end 235 of the sheath 225, and the sheath 225 surrounds the depicted portion of the tubular shaft 210. However, the proximal end of the shaft 210 may extend beyond the proximal end of the sheath 225 such that the shaft 210 may be moved relative to the sheath 225 to extend the needle 220 through the distal aperture 245 of the sheath 225 in other configurations discussed below. The lumen 205 of the shaft 210 extends through the sheath 225. In some embodiments, the fully retracted configuration may position the distal end 240 of the needle 220 within the sheath 225 a distance, e.g., 5mm, from the distal end 235 of the sheath 225. As shown in fig. 2A, the overlap region 215 may help to center the needle 220 with respect to the sheath 225.

Fig. 2B illustrates the needle assembly 200 in a partially extended configuration 205B. In the partially extended configuration 205B, the distal end 240 of the needle 220 is positioned distally beyond the distal end 235 of the sheath 225, with the shaft 210 positioned within the aperture 245 of the sheath 225. The needle 220 may be driven from the retracted configuration 205A to the partially extended configuration 205B by distal movement of the shaft 210.

Fig. 2C illustrates the needle assembly 200 in a fully extended configuration 205C. In the fully extended configuration 205C, the exposed portion 250 of the needle 220 (e.g., the portion positioned distal of the overlap region 215) is positioned distally beyond the distal end 235 of the sheath 225, wherein the overlap region 215 of the shaft 210 is positioned at least partially within the sheath 225. In some embodiments, the exposed portion 250 of the needle 220 may be positioned flush with the sheath 225, i.e., the distal edge 245 of the overlap region 215 may be positioned at the distal end 235 of the sheath 225. As shown in fig. 2C and discussed in more detail below with respect to fig. 3C, the overlap region 215 can help to center and anchor the needle 220 in the sheath 225, and thus in the working channel of the speculum, wherein the sheath 225 is positioned within the speculum even when the entire exposed length 250 of the needle extends beyond the distal end 235 of the sheath. The needle 220 may be driven from the partially extended configuration 205B to the fully extended configuration 205C by distal movement of the shaft 210, and the needle 220 may be driven from the fully extended configuration 205C to the partially extended configuration 205B by proximal movement of the shaft 210.

As described above, in some embodiments, in fully extended configuration 205C, distal tip 240 of needle 220 may extend 3cm or in the range of 2cm to 4cm beyond distal end 235 of sheath 225. The length of the needle 220 may be between 1cm and 6 cm. The overlap region 215 may overlap the proximal end of the needle 220 by a distance of 0.5cm to 3 cm. One example needle has an overlap area 215 length of about 1cm and an exposed needle length of about 2 cm. Another example needle has an overlap area 215 length of about 2cm and an exposed needle length of about 3 cm. Another example needle has an overlap area 215 length of about 2cm and an exposed needle length of about 4 cm. It will be appreciated that while longer needles provide greater ability to further sample the lesion from the distal tip of the speculum, longer needles may have reduced ability to traverse the tortuous passage of the speculum. It should also be understood that the dimensions provided above are merely exemplary, and that other dimensions may be suitable depending on the application and design requirements of the needle assembly.

Fig. 3A and 3B illustrate the needle assembly 200 of fig. 2A-2C exhibiting superelastic characteristics in the retracted and extended configurations. FIG. 3A illustrates the needle assembly 200 in a martensitic state 300A, wherein the needle assembly 200 is positioned within a working channel 320 of a speculum 315, the working channel 320 being illustrated in cross-section to show the needle assembly 200. Needle 220 may be positioned with its distal tip 240 within sheath 225. The sheath 225 and needle 220 can be advanced together through the working channel 320 of the speculum 315 until the distal end 235 of the sheath 225 and the distal end 240 of the needle 220 are positioned at (or near) the distal end 325 of the speculum 315.

As described above, in the martensitic state 300A, the needle is able to withstand strain up to a particular threshold while being reversibly deformed. As illustrated, the needle 220 has two folds along its longitudinal axis. As an example, in the martensitic state 300A, the needle 220 may bend with a radius of curvature of substantially a while reversibly deforming. In one example, the needle 220 may be about 5cm in length with 0.0015 inch thick walls, and the needle 220 may be resiliently bent at a radius of approximately 9mm to 12mm or more. Some examples of the needle 220 may be elastically deformed at a substantially 180 degree bend. This deformation can occur repeatedly as the sheath 225 containing the needle 220 is inserted through the working channel of the speculum.

Fig. 3B illustrates the needle assembly 200 in a deployment 300B. As illustrated, the assembly 200 has a portion 305 of the needle 220 still positioned within the sheath 225. In the martensitic state, a portion of the portion 305 is still deformed with a radius of curvature of approximately α. The assembly 200 also has the following portions 310 of the needle 220: the portion 310 has been "deployed", i.e., extended beyond the distal end 235 of the sheath 225. The deployed portion 310 is no longer strained by the bending of the sheath 225 and, as a result, the deployed portion 310 has reverted to the martensite phase and has therefore straightened. Beneficially, this self-reversible deformation allows the needle 220 to pass through the speculum closely across the bend and still be deployed substantially linearly along the longitudinal axis, extending out of the speculum working channel. Such a deployment increases the accuracy with respect to sampling the pre-identified target tissue region.

Further, an increase in stability and accuracy during deployment of the needle as illustrated in fig. 3B may be achieved by retaining the example portion 305 of the needle 220, the shaft 210, and the sheath 225 within the working channel 320 of the speculum 315. Although fig. 3B depicts a particular length of overlap of the needle 220, shaft 210, and sheath 225 within the working channel 320, it will be appreciated that any overlap of these components achieves the desired stability by securely centering the needle 220 in the working channel 320. For example, fig. 3C depicts a cross-sectional view 330 of the speculum 315, the sheath 225, the shaft 210, and the needle 220, illustrating an increased stability configuration along the portion 305 of fig. 3B. As illustrated, the outer surface of the sheath 225 contacts and is supported by the working channel 320 of the speculum 315, the inner surface of the sheath 225 contacts and supports the outer surface of the shaft 210, and the inner surface of the shaft 210 (e.g., at the overlap region 215) contacts and supports the outer surface of the needle 220. This arrangement centers the needle 220 relative to the working channel 320, thereby increasing accuracy during deployment. It will be appreciated that the gaps shown between the components in fig. 3C are for clarity of illustration, and that the overlapping configuration may be configured without gaps in various embodiments. Further, the working channel 320 may be centered with respect to the speculum 315 as illustrated, or the working channel 320 may not be centered in other embodiments.

Fig. 4A illustrates an example offset angle comparison 400 between a scope axis 410 and a scope axis 415 before and after a superelastic needle 420 is passed through the scope. The needle 420 may be the needle 120, 220 described above, and a sheath (not depicted) is located within the working channel of the scope 405. The depiction of FIG. 4A shows the distal end of the scope 405 in two positions 405A, 405B, each of the two positions 405A, 405B from one of the two images overlapping each other to produce the offset angle comparison 400. In a first image taken prior to insertion of the needle 420 through the scope, the distal end of the scope 405 is in an undeflected position 405A, wherein a portion of the scope proximal to the distal tip is actuated into a curve. In a second image taken after the needle 420 is deployed through the scope 405B, the distal end of the scope 405 is in the deflected position 405B. An imaginary line representing an undeflected axis 410 is depicted parallel to and extending from the distal end of the speculum 405 in the undeflected position 405A, and an imaginary line representing a deflected axis 415 is depicted parallel to and extending from the distal end of the speculum 405 in the deflected position 405B. These axes are offset by an angle theta. It should be noted that the illustrated deflections are experienced in air and may experience less deflection in the patient site. For example, while within the human body, surrounding tissue may restrict movement of the scope, or deflection may move the surgical site relative to the scope.

In the example shown in fig. 4A, the "spring" force of the superelastic needle 420, which attempts to return to its straightened, original shape through a curve, deflects the distal end of the speculum by a 5.6 degree deflection angle θ. In another example speculum, the angle β is reduced to 2 degrees. In some embodiments, the allowable deflection of the speculum tip due to needle deployment may be plus or minus ten degrees and still allow accurate sampling of the target tissue site. For purposes of illustration, it is considered that the working channel of the scope 405A is positioned to enable viewing of a target tissue site via optics located at the distal tip of the scope. Based on the size of the target lesion and the distance of the target lesion from the distal tip of the scope 405, the needle longitudinal axis angle after deflecting the scope tip (parallel to the deflected axis 415) may be offset within a certain range relative to the undeflected axis 410, and the distal tip of the needle 420 will still penetrate the target lesion.

In some embodiments, the scope 405 is steerable, and deflection can change the tension values of various pull wires or actuation cables within the scope 405. A robotic control system, such as discussed in more detail below with respect to fig. 6, may sense this change in tension and utilize this change in tension to compensate for the deflection of the speculum by applying greater tension or force to a particular pull wire or actuation cable. Some control system embodiments can compensate for changes in tension to bring the speculum as close as possible to its undeflected position 405A. Other control system embodiments may compensate for any tension variations that are outside of a predetermined range corresponding to the following deflection angle θ: the deflection angle θ exceeds an allowable angle for sampling the target tissue site. As an alternative to the automatic control method, other embodiments may correct the deflection based on the physician's adjustment of the scope.

Fig. 4B illustrates a comparison 425 of the angle of deflection between the disclosed superelastic needle 420 deployed outside of the scope 405 and a conventional needle 450, where both needles are deployed to the same distance 445 from the distal end of the scope. The conventional needle 450 is a short (e.g., up to 7mm long) stainless steel tube secured to the catheter 455. The distance 445 in this example is 4cm from the tip of the sight glass 405. Offset angle comparisons 425 involving extending two needles 420, 445 from the same scope 405 have the same deflection position, capturing images of each extended needle, and then overlapping the images to illustrate the comparison 425.

Dashed lines representing the axis 430 of the sight glass 405 are depicted parallel to and extending from the distal end of the sight glass 405. Dashed lines 435 representing the axis of the needle 420 of the present disclosure are depicted as extending from the needle 450. A dashed line 440 representing the axis of a conventional needle 450 is depicted as extending from the needle 450. As illustrated, the axis 440 of the needle 450 is offset by an angle β relative to the speculum axis 430, and the axis 435 of the needle 420 is offset by an angle γ relative to the speculum axis 430. In the depicted example angle comparison 425, the offset angle β between the axis 440 of the needle 450 and the speculum axis 430 is equal to 8.1 degrees, and the offset angle γ between the axis 435 of the needle 420 and the speculum axis 430 is equal to 1.8 degrees, plus or minus about 0.5 degrees. Thus, the disclosed superelastic needle 420 exhibits reduced deflection as compared to the conventional needle 450.

Fig. 5 illustrates an embodiment of a needle assembly 500 described herein, the needle assembly 500 being coupled to an example steering handle 505. Needle assembly 500 includes a needle 556, an elongate shaft 554 (e.g., a polymeric tube) bonded or otherwise secured to needle 556, a sheath 550 positioned at least partially around shaft 554 and needle 556, and a handle 505. In the view of fig. 5, a portion of handle 505 is shown in cross-section to show internal components.

The needle 556 may be formed of a superelastic material, such as nitinol, and the needle 556 may be bonded to the polymer tube via reflow soldering over the overlap region as described above. In various embodiments, needle 556 may be needle 100, 220, 420, shaft 554 may be elongate shaft 110, 210, and sheath 550 may be sheath 225. As illustrated, the sheath 550 extends from the distal port 541 of the handle 505 through the strain relief, and in various configurations, the sheath 550 may house some or all of the shaft 554 and the needle 556. The shaft 554 has the following lumen 552: this lumen 552 provides at least a portion of a fluid pathway between a proximal port of fluid coupling 535 of handle 505 and a distal end 559 of needle 556. The needle 556 may be a biopsy needle, such as a suction needle configured for suctioning tissue samples or the needle 556 may be configured to deliver therapeutic agents to a tissue site, and the needle 556 may be provided with a band 558 of radiopaque material near the distal end 559.

Handle 505 includes a housing 510, an actuation sleeve 520, a drive member 530, and a fluid fitting 535. Various examples of HANDLEs 505 and other HANDLEs suitable for ACTUATING the motion of the disclosed superelastic medical tool are described in U.S. application No.15/937,516 entitled "SHAFT actuated HANDLE," filed 2018, 3 and 27, the disclosure of which is incorporated herein by reference. The drive member 530 may be driven linearly along the longitudinal axis of the handle 505 by various forms of motion of the actuation sleeve 520, as described in more detail below. The shaft 554 attached to the needle 556 may be secured within the recess 537 of the drive member 530, for example by bonding via an adhesive. Thus, linear motion of the drive member 530 may be transferred to the needle 556 via the shaft 554, thereby allowing manipulation of the handle 505 to drive the needle 556 to extend and retract from the sheath 550. In some embodiments, the recess 537 may be configured to mechanically cooperate with a corresponding feature on the shaft 554 to facilitate use of the handle 505 with a number of different catheters and tools. Thus, in some embodiments, handle 505 may be sterilizable and reusable, while the catheter, needle, and sheath may be disposable. In various other embodiments, the entire instrument 500 may be completely sterilizable and reusable, or designed as a disposable single unit.

Actuation sleeve 520 may have a rotating wheel grip 524 and a plunger grip 522 to assist an operator in actuating actuation sleeve 520. The operator can drive movement of the needle 556 relative to the sheath 550 by rotating 560 the wheel grip 524, which causes rotation of the actuation shaft 520 about the longitudinal axis of the handle 505. Rotation 560 in one direction may cause the needle 556 to extend from the sheath 550. Rotation in the other direction may retract the needle 556 into the sheath 550. In some embodiments, the needle may be initially positioned in a retracted configuration, e.g., as shown in fig. 2A and 3A, while the sheath 550 is advanced near the target tissue site. Rotation 560 can be used to advance the distal end 559 of the needle out of the sheath 550 in a controlled and/or incremental manner until the distal end 559 is at or penetrates tissue. The insertion motion 565 may be driven in one direction by an operator applying a force to the plunger grip 522, and the insertion motion 565 is driven in the opposite direction by a biasing element when the force is released in some embodiments. Such a modality may be useful for dithering the needle 556 once extended to a desired distance, for example, to acquire a tissue sample.

The actuation sleeve 520 may be coupled to the drive member 530, for example, via a cam interface, to convert these rotational or insertion motions of the actuation sleeve 520 into linear motion of the drive member 530 along the longitudinal axis of the handle 505. The motion of the drive member 530 is in turn transmitted to the needle 556 via the coupling between the shaft 554 and the drive member 530 and the adhesion between the shaft 554 and the needle 556. Beneficially, the fluid fitting 535 may remain stationary relative to the housing 510 of the handle 505 during rotation 560 and insertion 565.

The fluid fitting 535 may be a threaded connection for fastening to a corresponding threaded connection of a suction device, such as a luer lock. Securing the fluid fitting 535 to the housing 510 may provide benefits in terms of stability of the suction device when secured to the fluid fitting 535. Beneficially, the fluid fitting 535 may remain stationary relative to the housing 510 of the handle 505 during rotation 560 and insertion 565. As shown, in some embodiments, the proximal portion 536 of the shaft 554 may include a length of coiled tubing. This may allow the fluid fitting 535 to be fixed relative to the housing 510 while providing a flexible fluid path that accommodates linear movement of the proximal handle member 530. For example, the proximal portion 536 may be a coiled HDPE tubing, and in some embodiments, the proximal portion 536 may be the portion of the shaft 554 located proximate the bonding recess 537. In some embodiments, a polyolefin heat shrink sleeve may be used to secure the coiled tubing to the fluid fitting.

The illustrated actuation sleeve 520 and grips 524, 522 represent one example structure for allowing a user to both actuate fine control extension of the needle 556 and actuate rapid whipping of the needle 556. In other embodiments, drive member 530 may be coupled with another suitable actuation mechanism, such as a rack and pinion driven by a rotatable wheel provided on handle 505 or a slidable tab provided on handle 505. Such alternative actuation mechanisms may be used alone or with a plunger-type dithering interface. Although described in the context of a superelastic needle, in other examples, handle 505 may be used to control other superelastic medical tools as described herein.

Overview of example robotic surgical systems

Fig. 6 depicts a schematic view of a robotic surgical system 600 for actuating a needle assembly 605 as described herein. The needle assembly includes a shield 630, a needle 635, a tubular elongate shaft 640 connected to the needle, and may be the needle assembly 200 described above. In other embodiments, the robotic system 600 may alternatively be engaged with a handle for manipulating the shaft 640, such as the handle 505 as described with reference to fig. 5. Other embodiments may engage with a support member bonded to the proximal end of shaft 640 and the proximal end of sheath 630.

The example robotic system 600 includes an articulated arm 610, the articulated arm 610 configured to determine a position of the needle assembly 605 and maintain the positioning of the needle assembly 605. At the distal end of the arm 610 there is arranged a first grip portion 625 for controlling suction or administration therapy and two additional grip portions 615, 620 which can be opened to receive and secure a shaft 640 and a sheath 630, respectively. The first gripping portion 625 may include one or more actuators for gripping and controlling a pressure source 655 of negative (or positive) pressure and/or a therapeutic device attached to the proximal end of the shaft 640. For example, the first grip portion 625 may include a first actuator, such as a syringe, for attaching the pressure source 655 and a second actuator for robotically controlling the plunger of the syringe. The second grip portion 615 may maintain a stationary position of the sheath 630. The third grip portion 620 may be configured to move the proximal end of the shaft 640 proximally and distally to move the needle 635 in and out of the sheath 630 and/or to affect a whipping motion as described herein. Other embodiments of the third grip portion 620 may be configured to affect the rotation and/or insertion modality of the handle as described herein by rotating the wheels or grip portion of the handle. The gripping portions 615, 620, 625 may be driven by one or more motors or appropriate actuation mechanisms.

The robotic surgical system 600 may include processor(s) 645 and memory 650. The memory 650 may store instructions for operating the various components of the robotic surgical system 600 as well as data generated and used during a surgical procedure. Processor(s) 645 may execute the instructions and process such data to cause system 600 to operate. One example of instructions stored in the memory of the robotic surgical system 600 is implemented in the tissue sampling method of fig. 7 as discussed below.

For example, the memory 650 may store data related to the length of the needle and/or the overlap region as well as instructions related to extending the needle from the sheath in order to position the distal end of the needle a desired distance from the distal end of the sheath while maintaining overlap between the needle 220, the shaft 210, the sheath 225, and the working channel 320 of the scope 315 during deployment, e.g., as shown in fig. 3B and 3C. Processor(s) 645 may execute these instructions to cause system 600 to operate to extend the needle in a stable and accurate manner as described herein. For example, the processor(s) 645 may execute the instructions to cause the robotic system to monitor the positioning of the region of overlap between the needle and the shaft relative to one or both of the sheath and the working channel/endoscope during or after extension actuation of the needle. In some embodiments, the instructions may prevent the robotic surgical system 600 from driving the needle to extend beyond a predetermined point that would eliminate such overlap. In other embodiments, the instructions may cause the robotic surgical system 600 to provide an alert to an operator of the robotic surgical system 600 when further extension will eliminate such overlap, but may allow the operator to continue to drive extension of the needle.

In other embodiments, processor(s) 645 may execute instructions stored in memory 650 to cause robotic surgical system 600 to automatically position scope 315 (prior to or during insertion of needle assembly 200 through working channel 320) such that needle 220 will be able to extend to a target tissue site while maintaining the overlap described herein. Additionally or alternatively, processor(s) 645 may execute instructions stored in memory 650 to cause robotic surgical system 600 to output recommendations regarding such positioning to a user utilizing system 600 to drive endoscope positioning. Additionally or alternatively, the processor(s) 645 may execute instructions stored in the memory 650 to enable the robotic surgical system 600 to cause the robotic surgical system 600 to output an alert to a user when the scope has been driven to such a position.

As described above, deflection of the tip of the speculum due to passage of the needle through a bend located near the tip of the speculum can be monitored and compensated for via tension on the actuation cable of the speculum. Thus, in one embodiment, the memory may store: (1) instructions for monitoring tension on the cable to detect endoscope tip deflection; and (2) instructions for determining a tension value to apply to compensate for a particular speculum deflection condition when detected. For example, once the tip of the speculum is in place, the instructions may include monitoring the actuation cable for tension changes or any changes above a threshold level. The instructions can also identify specific cables (e.g., cables positioned along the scope inside a radius of curvature at the scope tip bend) to monitor for these specific increases in tension, and/or the instructions can identify specific cables (e.g., cables positioned along the scope outside a radius of curvature) to monitor for these specific decreases in tension. The instructions may also include timing parameters and/or inputs from the needle navigation system to monitor and compensate for such tension changes during specific time periods, such as from the time of approach of the tip of the scope at the distal end of the needle to the time during deployment of the needle from the scope. The timing parameters may also specify that: the robotic surgical system 600 does not adjust the curvature of the tip of the scope to compensate for tension variations during penetration of tissue by the needle 635 in order to maintain a straight minimally invasive path of the needle 635 into the tissue. In some embodiments, scope deflection detection and compensation can be performed by additional robotic systems configured for controlling navigation of the scope in addition to or in lieu of the illustrated system 600.

Although not shown, the robotic surgical system 600 may also include other components, such as one or more input devices for receiving user input to control the motion of a surgical instrument (e.g., joystick, handle, computer mouse, trackpad, and gesture detection system), an instrument driver to affect the motion of the disclosed needle, a display screen, and so forth. Although described in the context of a superelastic needle, in other examples, robotic surgical system 600 may be used to control other superelastic medical tools, and robotic surgical system 600 may be used in other types of medical procedures as described herein.

Overview of example methods of use

Fig. 7 depicts a flow chart of an embodiment of a method 700 for obtaining a tissue sample using a needle described herein, e.g., needle 120, needle 220, needle 420, needle 556, needle 635 described above. The method 700 may be implemented by an operator manually manipulating a tube secured to a needle, for example, by means of a handle 505 as shown in fig. 5, by a robotic control system operator (such as the system 600 described above) that mechanically manipulates the tube through direction by the operator or autonomously, or by a combination of the two. Although described in the exemplary context of controlling a needle to obtain a tissue sample in bronchoscopy, it will be understood that variations of method 700 may be implemented with other superelastic medical tools and in other types of medical procedures as described herein.

At block 705, an operator (e.g., an operator or an autonomous surgical robot) may position the sheath 225, 550, 630 housing the needle 120, 220, 420, 556, 635 near a tissue site of a patient, e.g., positioned within reach of the needle or other instrument within the sheath. As described above, the needle may be positioned with its distal tip 125, 240, 559 at or near the distal end 235 of the sheath, and the elongate shaft 110, 210, 554, 640 may extend from the proximal end of the needle through the sheath. In some embodiments, the sheath can be inserted through a working channel of an endoscope, such as a bronchoscope. In some embodiments, the elongate shaft may be coupled to a handle 505 for driving linear movement of the shaft relative to the sheath.

As described above, in some embodiments, the system 600 may automatically position the endoscope 315 such that: when the needle 220 extends from the sheath 225 into the pre-identified target tissue site, the proximal portion of the needle, the distal portion of the shaft 210, and the distal portion of the sheath 225 will remain in an overlapping position 305 within the working channel 320 of the endoscope. In some embodiments, the system 600 may additionally or alternatively provide guidance to a user of the system 600 regarding maintaining such overlapping positioning. For example, the system 600 can determine that the sheath 225 is positioned within the working channel 320 of the endoscope 315 and the system 600 can also determine that the overlap region 215 between the needle 220 and the shaft 210 remains at least partially positioned within the sheath 225 during or after actuation of the needle 200. In another embodiment, the system 600 can determine during or after actuation of the needle 220 that the overlap region 215 is still positioned at least partially within the working channel 320 of the endoscope 315. In some examples, such a determination may be made based on feedback from the system 600, such as based on robotic position data indicating the distance the needle assembly 200 is fed through the scope 210.

At block 710, the operator may move the shaft 210 coupled to the needle 220 distally to drive the distal end of the needle 220 to advance through the sheath 225. As described above and as shown in the example of fig. 5, this may involve actuation of a rotational modality of the handle, for example, by rotating grip 522. Actuation of this modality may allow the operator fine control over extending the distal tip of the needle from the distal end of the cannula. In some procedures, this may involve extending the distal tip of the needle until it has pierced the patient tissue. In other embodiments, the tube may be advanced through the instrument driver of the robotic surgical system 600 with or without the use of such a handle. As described above, block 710 can be performed to maintain an overlap between the proximal portion of the needle, the distal portion of the tube, and the distal portion of the sheath within the working channel of the endoscope. Such overlap may improve the accuracy of needle deployment by centering the needle relative to the working channel.

Some embodiments may first perform block 705 and/or block 710 in a "fast mode" that quickly moves the needle 220 to a predetermined distance from the distal end 325 of the endoscope 315, and then the operator may manually control (by the handle 505 or via actuation of the system 600) further extension of the needle 220. Some embodiments may operate in a fully autonomous mode, for example, by tracking the position of the needle 200 with a position sensor (e.g., an Electromagnetic (EM) sensor located on the needle and/or a scope disposed within an EM field generated around the tissue site) so that the system 600 can determine the relative positions of the needle 220, the scope 315, and the tissue site.

At block 715, the operator may determine that the distal end of the needle is positioned at the target tissue site. In some embodiments, a physician may view an image or video of the tissue site via an imaging device located at the distal end of the endoscope working channel, and the physician may visually confirm that the needle is positioned at or within the target tissue site. This may be accomplished, for example, by fluoroscopy and the physician may view the position of the radiopaque material 123, 230, 558 to identify the needle position. In some embodiments, a physician may view a rendered map or model of the positioning of the instrument relative to the patient tissue site to make this determination, for example as output from a robotic bronchoscope navigation system. In some implementations, block 715 may be performed programmatically through automatic image analysis and/or navigation.

At block 720, the operator may obtain a tissue sample with the needle. As described above and as shown in the example of fig. 5, this may involve a shaking motion actuated by an insertion mode, e.g., by inserting grip 522. Further, this may involve coupling a source of negative pressure to the proximal end of the tube, e.g., via the fluid fitting 535.

At block 725, the operator may move the tube proximally to withdraw the distal end of the needle into the sheath, e.g., via a rotational motion interface, and the sheath may be withdrawn from the patient tissue site. Any sample obtained may be expelled from the instrument for the desired analysis.

Implementation System and terminology

Embodiments disclosed herein provide superelastic needle assemblies and methods of using the superelastic assemblies.

It should be noted that the terms "coupled," "coupled," or other variations of the term coupled, as used herein, may indicate either an indirect connection or a direct connection. For example, if a first component is "coupled" to a second component, the first component may be indirectly connected to the second component via another component, or directly connected to the second component.

The robot motion actuation functions described herein may be stored as one or more instructions on a processor-readable or computer-readable medium. The term "computer-readable medium" refers to any available medium that can be accessed by a computer or processor. By way of example, and not limitation, such media can comprise RAM, ROM, EEPROM, flash memory, CD-ROM or other optical disk storage, magnetic disk storage or other magnetic storage devices, or any other medium that can be used to store desired program code in the form of instructions or data structures and that can be accessed by a computer. It should be noted that the computer readable medium may be tangible and non-transitory. As used herein, the term "code" may refer to software, instructions, code or data capable of being executed by a computing device or processor.

The methods disclosed herein comprise one or more steps or actions for achieving the described method. The method steps and/or actions may be interchanged with one another without departing from the scope of the claims. In other words, unless a specific order of steps or actions is required for proper operation of the method being described, the order and/or use of specific steps and/or actions may be modified without departing from the claims.

As used herein, the term "plurality" means two or more. For example, a plurality of components means two or more components. The term "determining" encompasses a variety of actions, and thus "determining" can include calculating, calculating with a computer, processing, deriving, investigating, looking up (e.g., looking up in a table, a database or another data structure), ascertaining and the like. Additionally, "determining" may include receiving (e.g., receiving information), accessing (e.g., accessing data in a memory), and the like. Further, "determining" may include resolving, selecting, establishing, and the like.

The term "based on" does not mean "based only on," unless explicitly stated otherwise. In other words, the term "based on" describes both "based only on" and "based at least on".

The previous description of the disclosed embodiments is provided to enable any person skilled in the art to make or use the present invention. Various modifications to these embodiments will be readily apparent to those skilled in the art, and the generic principles defined herein may be applied to other embodiments without departing from the scope of the invention. For example, it will be understood that one of ordinary skill in the art will be able to implement several corresponding alternative or equivalent structural details, such as equivalent ways of fastening, mounting, coupling, or engaging tool components, equivalent mechanisms for producing a particular actuation motion, and equivalent mechanisms for delivering electrical energy. Thus, the present invention is not intended to be limited to the embodiments shown herein but is to be accorded the widest scope consistent with the principles and novel features disclosed herein.