WO2018013127A1

WO2018013127A1 - Needle handle

Info

Publication number: WO2018013127A1
Application number: PCT/US2016/042348
Authority: WO
Inventors: Matthew E. NICKESON; Madeline C. GRAHAM
Original assignee: Spiration, Inc., D.B.A. Olumpus Respiratory America
Priority date: 2016-07-14
Filing date: 2016-07-14
Publication date: 2018-01-18
Also published as: CN109475353B; JP2019527095A; GB201900309D0; DE112016007061T5; GB2566231B; CN109475353A; GB2566231A; JP6818864B2

Abstract

A medical instrument having an aspiration needle and handle device. The handle device controls the force required for a user to activate the needle and provides a higher force to initially activate and a lower force to continue sliding. Grooves at either end of the activation act as locking elements which provide feedback with a "pop" sound at either end of the travel. The handle also supports "one-way" manufacturing of the handle assembly, with an O-ring passing over a larger diameter shaft during initial assembly, thus preventing disassembly.

Description

NEEDLE HANDLE

FIELD

[0001] The present invention relates to needle aspiration devices used for tissue sampling.

BACKGROUND

[0002] The statements in this section merely provide background information related to the present disclosure and may not constitute prior art.

[0003] Needle aspiration devices, such as transbronchial needle aspiration (TBNA) devices, are used to collect samples from target tissue, such as tumors and nodules, for analysis.

[0004] Some needle aspiration handle designs use simple cantilever springs, friction fits or O-rings. The earlier O-ring designs offer some "locking" ability with a groove to seat the O-ring. However, those grooves are generally shallow, which could also allow the needle to accidentally advance without the user's input, causing a potential safety issue or scope damage.

SUMMARY

[0005] The present invention provides an example medical instrument for sampling tissue. The example medical instrument includes a handle that controls the force required for a user to activate the needle and provides a higher force to initially activate with a lower force to continue sliding. Grooves at either end of the activation act as locking elements which provide feedback with a "pop" sound at either end of the travel. The handle also supports "one-way" manufacturing of the handle assembly, with an O-ring passing over a large diameter shaft during initial assembly, thus preventing disassembly. The O-ring and groove interface is also designed not to provide a fluid seal (as would be traditional for O-rings) in order to support sterilization methods.

[0006] The higher initial activation force provides safety from unintentional activation. A change in slope of an outside diameter of a needle actuator shaft offers a better feeling when retracting the needle. The 'pop' at either end of needle actuator travel offers tactile and audible feedback to the user.

[0007] Further features, advantages, and areas of applicability will become apparent from the description provided herein. It should be understood that the description and specific examples are intended for purposes of illustration only and are not intended to limit the scope of the present disclosure.

DRAWINGS

[0008] The drawings described herein are for illustration purposes only and are not intended to limit the scope of the present disclosure in any way. The components in the figures are not necessarily to scale, emphasis instead being placed upon illustrating the principles of the invention. In the drawings:

[0009] FIGURE 1-1 illustrates an side view of an aspiration device in a deactivated state in accordance with principles of the present invention;

[0010] FIGURE 1-2 illustrates a cross-sectional view of the aspiration device of FIGURE 1-1 ;

[0011] FIGURE 1-3 illustrates an side view of the aspiration device of FIGURE 1- 1 in an activated state in accordance with principles of the present invention;

[0012] FIGURE 2-1 illustrates a side view of a needle actuator of the aspiration device of FIGURE 1-1 in accordance with principles of the present invention;

[0013] FIGURE 2-2 illustrates a close-up view of a portion of the needle actuator of FIGURE 2-1 ;

[0014] FIGURE 3-1 illustrates a side view of a handle body of the aspiration device of FIGURE 1-1 in accordance with principles of the present invention;

[0015] FIGURE 3-2 illustrates a cross-sectional view of the handle body of FIGURE 3-1 ; and

[0016] FIGURE 3-3 illustrates a cross-sectional view of a portion of the handle body of FIGURES 3-1 and 3-2. DETAILED DESCRIPTION

[0017] The following description is merely exemplary in nature and is not intended to limit the present disclosure, application, or uses.

[0018] FIGURES 1-1 and 1-2 illustrate an example needle aspiration device 20 (e.g., transbronchial needle aspiration (TBNA) device) in a deactivated position and FIGURE 1-3 illustrates the device 20 in an activated position. The device 20 includes a handle body 26, a needle actuator 28, a stylet knob 30 and a Luer component 32. The handle body 26 is attached to a proximal end of a sheath 34. The needle actuator 28 includes a shaft portion 36 coupled to a handle portion 38. The needle actuator 28 receives and is attached to a proximal end of a needle 40. The stylet knob 30 is attached to a proximal end of a stylet 46. The stylet knob 30 rotatably receives to a proximal end of the Luer component 32. A distal end of the Luer component 32 is attached to a cavity of the handle portion 38 of the needle actuator 28.

[0019] In the deactivated position, the distal end of the needle 40 is retracted within the sheath 34 (FIGURE 1-2). In the activated position, the distal end of the needle 40 is exposed beyond the distal end of the sheath 34 (FIGURE 1-3).

[0020] As shown in FIGURE 1-2, the shaft portion 36 is slidably received within a cavity (i.e., lumen) of the handle body 26. At a proximal end of the cavity of the handle body 26 is an annular groove 52 that receives at least a portion of an O-ring 50. The O-ring 50 keeps the shaft portion 36 from being easily removed from the handle body 26. Interactive operation of the parts of the device 20 are described in more detail below.

[0021] As shown in FIGURES 2-1 and 2-2, the shaft portion 36 of the needle actuator 28 includes a distal section 58, a middle section 62 and a proximal section 60. The distal section 58 and the middle section 62 are separated by a distal annular groove 54. The middle section 62 and the proximal section 60 are separated by a proximal annular groove 56. The distal section 58 has an outside diameter that is approximately the same as the inside diameter of the cavity of the handle body 26. As part of assembly, the shaft portion 36 is inserted into the cavity of the handle body 26. The distal section 58 is forced past the O-ring 50 until the O-ring 50 becomes seated within the distal annular groove 54. At this position, the device 20 is ready for operation with the distal end of the needle 40 being proximal to the distal end of the sheath 34. The O-ring 50 prevents the distal section 58 of the needle actuator 28 from being completely pulled out of the handle body 26.

[0022] A user initiates needle activation by applying a distal force on the handle portion 38 of the needle actuator 28 thus causing the O-ring 50 to pop out of the distal annular groove 54 and slide along the shaft portion 36 until the O-ring 50 'pops' into place at the end (e.g., the proximal annular groove 56), at which point the needle is fully extended (e.g., about 20mm) from the sheath 34.

[0023] A ramp 66 is located from the proximal edge of the distal annular groove 54 to a predefined location proximally along the shaft portion 36. The outside diameter 64 of the ramp 66 decreases from the proximal edge of the distal annular groove 54 to a proximal end of the ramp 66. The shaft portion 36 located between the proximal end of the ramp 66 and the proximal annular groove 56 has a mostly constant diameter value. The value of the diameter of the distal end of the ramp 66 is chosen in order to provide audible and/or tactile feedback to the operator as the operator applies an initiation force to the needle actuator 28 in the distal direction. The ramp 66 provides for an asymmetric force difference between the activation force, which is relatively sudden and noticeable, and the retraction force, which is smoother and subtler than the activation force.

[0024] The distal section 60 may have a diameter value that is greater than the non-ramp portion of the middle section 62. The O-ring 50 seated into the proximal annular groove 56 helps to keep the needle actuator 28 in a fully distal position. The device 20 may be implemented without the distal section 60 or the distal annular groove 54.

[0025] In one embodiment, the distal annular groove 54 is slightly deeper than the proximal annular groove 56. This helps to keep the needle 40 locked in a retracted position until physician initiated activation occurs. The distal annular groove 54 may be flanked by a slope on a proximal side and a sharper, wider end on the distal side. The wider side making contact with the O-ring 50 prevents the actuator from being completely pulled out from the handle body 26.

[0026] Other shapes and dimensions for the device 20 may be used, including intermediate ramps or divots, to vary the activation force and feel during use. For instance a notch or bump at a half-way point between zero and full activation may be used to provide physicians with feedback about the location of the midway point.

[0027] As shown in FIGURES 3-1, 3-2 and 3-3, a barb 44 is located at the distal end of the handle body 26. The barb 44 includes a distal cavity 70 and a proximal cavity 72. The proximal cavity 72 has a smaller inside diameter than the distal cavity 70 but is still large enough to slidably receive the needle 40. The distal cavity 70 is sized to receive a proximal end of the sheath 34 up to a shelf formed due to the diameter disparity between the distal cavity 70 and the proximal cavity 72. The barb 44 includes a tapered distal end that expands proximally until about midway the length of the barb 44 where a flange 74 is formed. The shaft of the barb 44 has a constant outside diameter from the tapered distal end to the distal end of the handle body 26. The flange 74 allows for greater adhesion to a strain relief liner 42.

[0028] After the sheath 34 has been inserted into the distal cavity 70, the strain relief liner 42 is drawn or applied over the sheath 34 and the barb 44. If the strain relief liner 42 is formed at least partially of heat shrink material, heat is applied to it, thus causing it to shrink and apply radial forces to the sheath 34 and the barb 44. The heat shrink material may include an adhesive located on its inner surface for allowing for greater adhesion between the parts. This adhesive may also be heat activated.

[0029] A. A medical device comprising: a needle having a distal end and a proximal end; a needle actuator comprising: an actuator section located at a proximal end of the needle actuator; a shaft section having a distal end and a proximal end, the proximal end of the shaft section being connected to the actuator section, the shaft section comprising: a first section having a first outer diameter value; a second section comprises a portion having an outside diameter that transitions distally from a second outside diameter value to a third outside diameter value, the first outside diameter value and the third outside diameter value are greater than the second outside diameter value; and a first annular groove located between the first section and the second section; and a lumen located within one of the actuator section or the shaft section, the lumen configured to securably receive the proximal end of the needle; a sheath having a distal end and a proximal end, the sheath comprises a lumen configured to receive the needle; and a handle body having a distal end and a proximal end, the distal end of the handle body being coupled to the proximal end of the sheath, the handle body comprises a lumen.

[0030] B. The medical device of A, wherein the handle body further comprises: an annular groove within the lumen of the handle body; and an O-ring at least partially received by the annular groove of the handle body.

[0031] C. The medical device of B, wherein an inner diameter of the O-ring is less than the first outside diameter value.

[0032] D. The medical device of any of A-C, wherein the shaft section further comprises a second annular groove located between the second section and the actuator section.

[0033] E. The medical device of D, wherein the first annular groove is deeper than the second annular groove.

[0034] F. The medical device of any of D or E, wherein the shaft section further comprises a third section located between the second annular groove and the actuator section, the third section has a fourth outside diameter value, the fourth outside diameter value is greater than the second outside diameter value.

[0035] G. The medical device of any of B-F, wherein the O-ring is seated within the first annular groove when the medical device is in a deactivated state.

[0036] H. The medical device of any of D or E, wherein the O-ring is seated within the second annular groove when the medical device is in an activated state.

[0037] I. The medical device of any of A-H, wherein the handle body further comprises a port configured to receive the proximal end of the sheath within a cavity, the port protrudes distally from the handle body, the inner diameter of the cavity is greater than the inner diameter of the lumen of the handle body.

[0038] J. The medical device of I, further comprising an attachment device configured to apply for attaching force between the port and the sheath.

[0039] K. The medical device of L, wherein the attachment device comprises a heat shrink material.

[0040] L. A handle device comprising: a needle actuator comprising: an actuator section located at a proximal end of the needle actuator; a shaft section having a distal end and a proximal end, the proximal end of the shaft section being connected to the actuator section, the shaft section comprising: a first section having a first outer diameter value; a second section comprises a portion having an outside diameter that transitions distally from a second outside diameter value to a third outside diameter value, the first outside diameter value and the third outside diameter value are greater than the second outside diameter value; and a first annular groove located between the first section and the second section; and a lumen located within one of the actuator section or the shaft section, the lumen configured to securably receive the proximal end of a needle; and a handle body having a distal end and a proximal end, the distal end of the handle body being coupled to a distal end of a sheath, the handle body comprising a lumen.

[0041] M. The handle device of L, wherein the handle body further comprises: an annular groove within the lumen of the handle body; and an O-ring at least partially received by the annular groove of the handle body.

[0042] N. The handle device of M, wherein an inner diameter of the O-ring is less than the first outside diameter value.

[0043] O. The handle device of any of L-N, wherein the shaft section further comprises a second annular groove located between the second section and the actuator section.

[0044] P. The handle device of O, wherein the first annular groove is deeper than the second annular groove.

[0045] Q. The handle device of any of L-P, wherein the O-ring is seated within the first annular groove when the medical device is in a deactivated state.

[0046] R. The handle device of any of O or P, wherein the O-ring is seated within the second annular groove when the medical device is in an activated state.

[0047] S. The handle device of any of O or P, wherein the shaft section further comprises a third section located between the second annular groove and the actuator section, the third section has a fourth outside diameter value, the fourth outside diameter value is greater than the second outside diameter value. [0048] T. The handle device of any of L-S, further comprising: an attachment device coupled to a proximal end of the actuator section; and a stylet knob rotatably received by the attachment device, the stylet knob is configured to receive a proximal end of a stylet.

[0049] The description of the invention is merely exemplary in nature and variations that do not depart from the gist of the invention are intended to be within the scope of the invention. Such variations are not to be regarded as a departure from the spirit and scope of the invention.

Claims

CLAIMS What is claimed is:

1. A medical device comprising:

a needle having a distal end and a proximal end;

a needle actuator comprising:

an actuator section located at a proximal end of the needle actuator; a shaft section having a distal end and a proximal end, the proximal end of the shaft section being connected to the actuator section, the shaft section comprising:

a first section having a first outer diameter value;

a second section comprises a portion having an outside diameter that transitions distally from a second outside diameter value to a third outside diameter value, the first outside diameter value and the third outside diameter value are greater than the second outside diameter value; and

a first annular groove located between the first section and the second section; and

a lumen located within one of the actuator section or the shaft section, the lumen configured to securably receive the proximal end of the needle;

a sheath having a distal end and a proximal end, the sheath comprises a lumen configured to receive the needle; and

a handle body having a distal end and a proximal end, the distal end of the handle body being coupled to the proximal end of the sheath, the handle body comprises a lumen.

2. The medical device of Claim 1, wherein the handle body further comprises:

an annular groove within the lumen of the handle body; and

an O-ring at least partially received by the annular groove of the handle body.

3. The medical device of Claim 2, wherein an inner diameter of the O-ring is less than the first outside diameter value.

4. The medical device of any of Claims 1-3, wherein the shaft section further comprises a second annular groove located between the second section and the actuator section.

5. The medical device of Claim 4, wherein the first annular groove is deeper than the second annular groove.

6. The medical device of any of Claims 4 or 5, wherein the shaft section further comprises a third section located between the second annular groove and the actuator section, the third section has a fourth outside diameter value, the fourth outside diameter value is greater than the second outside diameter value.

7. The medical device of any of Claims 2-6, wherein the O-ring is seated within the first annular groove when the medical device is in a deactivated state.

8. The medical device of any of Claims 4 or 5, wherein the O-ring is seated within the second annular groove when the medical device is in an activated state.

9. The medical device of any of Claims 1-8, wherein the handle body further comprises a port configured to receive the proximal end of the sheath within a cavity, the port protrudes distally from the handle body, the inner diameter of the cavity is greater than the inner diameter of the lumen of the handle body.

10. The medical device of Claim 9, further comprising an attachment device configured to apply for attaching force between the port and the sheath.

11. The medical device of Claim 10, wherein the attachment device comprises a heat shrink material.

12. A handle device comprising:

a needle actuator comprising:

a first section having a first outer diameter value;

a lumen located within one of the actuator section or the shaft section, the lumen configured to securably receive the proximal end of a needle; and

a handle body having a distal end and a proximal end, the distal end of the handle body being coupled to a distal end of a sheath, the handle body comprising a lumen.

13. The handle device of Claim 12, wherein the handle body further comprises:

an annular groove within the lumen of the handle body; and

an O-ring at least partially received by the annular groove of the handle body.

14. The handle device of Claim 13, wherein an inner diameter of the O-ring is less than the first outside diameter value.

15. The handle device of any of Claims 12-14, wherein the shaft section further comprises a second annular groove located between the second section and the actuator section.

16. The handle device of Claim 15, wherein the first annular groove is deeper than the second annular groove.

17. The handle device of any of Claims 12-16, wherein the O-ring is seated within the first annular groove when the medical device is in a deactivated state.

18. The handle device of any of Claims 15 or 16, wherein the O-ring is seated within the second annular groove when the medical device is in an activated state.

19. The handle device of any of Claims 15 or 16, wherein the shaft section further comprises a third section located between the second annular groove and the actuator section, the third section has a fourth outside diameter value, the fourth outside diameter value is greater than the second outside diameter value.

20. The handle device of any of Claims 12-19, further comprising:

an attachment device coupled to a proximal end of the actuator section; and a stylet knob rotatably received by the attachment device, the stylet knob is configured to receive a proximal end of a stylet.