MULTI-FUNCTIONAL MEDICAL DEVICE
20180008296 · 2018-01-11
Assignee
Inventors
- James A. TEAGUE (Spencer, IN, US)
- Eric CHENG (New Richmond, OH, US)
- Mohamed Fazni AZIZ (Bloomington, IN, US)
Cpc classification
A61B2017/00336
HUMAN NECESSITIES
A61B17/221
HUMAN NECESSITIES
International classification
Abstract
An embodiment of a medical device includes a proximal handle, a distal end effector, an elongate member connecting the end effector to the handle, and a sheath enclosing at least a portion of the elongate member. The handle may include a first mechanism coupled to one of the sheath and the elongate member to move the sheath relative to the elongate member, a second mechanism coupled to the elongate member to rotate the elongate member relative to the handle, and a locking mechanism coupled to the first mechanism to hold the first mechanism in a default position. Embodiments also include methods of positioning the medical device to perform a medical procedure.
Claims
1-38. (canceled)
39. A medical device, comprising: a handle having a proximal end and a distal end; a sheath having a lumen extending along a longitudinal axis; a shaft having a proximal end received by the handle, and a distal end including an end-effector, wherein at least a portion of the shaft extends through the lumen of the sheath; a first actuator coupled to one of the sheath and the shaft, the first actuator including a rotatable member and a linearly translatable member, wherein the rotatable member is movable into and out of engagement with the linearly translatable member, wherein the rotatable member is biased to move out of engagement with the linearly translatable member, and wherein the rotatable member is rotatable about an axis perpendicular to the longitudinal axis; and a second actuator coupled to the shaft and rotatable about an axis that is one of coaxial with and parallel to the longitudinal axis.
40. A medical device of claim 39, wherein the rotatable member includes a first set of gear teeth and the linearly translatable member includes a second set of gear teeth.
41. A medical device of claim 40, wherein the first set of gear teeth engage the second set of gear teeth when the rotatable member is pressed towards the linearly translatable member.
42. A medical device of claim 39, wherein the first actuator is located distally from the second actuator.
43. A medical device of claim 41, wherein the rotatable member is configured to translate the linearly translatable member along the longitudinal axis when the first set of gear teeth and the second set of gear teeth are engaged, and the rotatable member is rotated.
44. The medical device of claim 39, wherein the rotatable member is positioned for actuation by a thumb or finger of one hand of a user.
45. The medical device of claim 39, wherein the second actuator includes a knob, wherein the knob is partially exposed via an opening on the handle, and wherein the knob is located between the rotatable member and the proximal end of the handle.
46. The medical device of claim 40, further comprising a locking system configured to prevent rotation of the rotatable member when the first and second sets of gear teeth are disengaged, by engaging the first set of gear teeth.
47. The medical device of claim 39, wherein the second actuator engages one of a pinch vise, a clip, a staple, and a clamp that fixedly retains the shaft.
48. The medical device of claim 39, wherein the second actuator is positioned for actuation by a thumb or finger of one hand of a user.
49. A medical device, comprising: a handle having a proximal end and a distal end; a sheath having a lumen extending along a longitudinal axis; a shaft having a proximal end received by the handle and a distal end including an end-effector, wherein at least a portion of the shaft extends through the lumen of the sheath; a first actuator coupled to one of the sheath and the shaft, wherein the first actuator includes a rotatable member and a linearly translatable member, wherein the rotatable member is movable into and out of engagement with the linearly translatable member, wherein the rotatable member is biased to move out of engagement with the linearly translatable member, and wherein the rotatable member is rotatable about an axis extending transverse to the longitudinal axis; a second actuator coupled to the shaft and rotatable about an axis that extends in a direction in which the longitudinal axis extends; and a stiffening member extending along the longitudinal axis and at least partially received by the linear translatable member, wherein the stiffening member circumferentially surrounds the shaft.
50. The medical device of claim 49, wherein the stiffening member is at least partially received within the sheath.
51. The medical device of claim 49, wherein the linearly translatable member is moveable with the stiffening member.
52. The medical device of claim 49, wherein rotation of the second actuator rotates the stiffening member.
53. The medical device of claim 49, wherein the stiffening member is positioned proximal to the distal end of the handle.
54. A method of positioning a medical device to perform a medical procedure, comprising: with a distal end effector of a medical device positioned within a sheath of the medical device, advancing the distal end effector to a treatment site, wherein the distal end effector is operatively coupled to a handle of the medical device via a shaft that extends through the sheath; moving a first actuator of the handle from a first state toward a second state by pressing a first rotatable member of the first actuator in a direction transverse to a longitudinal axis of the sheath, wherein in the first state, the first rotatable member engages a portion of a housing of the handle, and wherein in the second state, the first rotatable member disengages from the portion of the housing, and the first rotatable member engages a linearly translatable member coupled to the shaft or the sheath; extending the distal end effector distally of the sheath by rotating the first rotatable member to longitudinally advance the linearly translatable member; and actuating a second actuator of the handle to rotate the end effector about the longitudinal axis of the sheath.
55. The method of claim 54, wherein pressing the first rotatable member overcomes a biasing force that biases the first rotatable member away from the linearly translatable member.
56. The method of claim 55, further including releasing the first rotatable member to allow the biasing force to return the first actuator to the first state.
57. The method of claim 54, wherein actuating the second actuator comprises rotating a second rotatable member that in turn rotates a shaft fixedly attached to the distal end effector.
58. The method of claim 57, wherein rotating the second rotatable member includes rotating the second rotatable member about a rotation axis that is transverse to a rotation axis of the first rotatable member.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0018] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate several embodiments of the invention and together with the description, serve to explain the principles of the invention.
[0019]
[0020]
[0021]
[0022]
[0023]
[0024]
[0025]
[0026]
[0027]
[0028]
[0029]
DESCRIPTION OF THE EMBODIMENTS
[0030] Reference will now be made in detail to the exemplary embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts.
[0031]
[0032] The sheath 20 defines a lumen dimensioned to fully enclose the elongate member 18 and the end effector 16 when the end effector 16 is in the retracted position (not shown). The sheath 20 extends from the distal end 24 of the handle 12 to the end effector 16. When extended past the proximal end of the end effector 16, the sheath 20 envelopes the end effector 16, placing the end effector 16 in a collapsed state. When the sheath 20 moves proximally relative to the end effector 16, it exposes the end effector 16 and leaves it in an expanded state (shown in
[0033] The sheath 20 may be formed from various biocompatible materials or combination of biocompatible materials known in the art. Such materials may include, but are not limited to, polyimide, PEBAX, stainless steel (such as 300 and 400 series), cobalt, chromium, nickel, titanium, nitinol, thermoforming plastic, polytetrafluoroethylene (“PTFE”), and expanded polytetrafluoroethylene (“ePTFE”). The sheath 20 may also be a metal coated with a polymer and may have one or more layers of material. Additionally, any of the materials discussed below or combination thereof with respect to the elongate member 18 may form the sheath 20.
[0034] The length and diameter of the sheath 20 may vary depending on the application. A relatively long sheath 20 may be advantageous for retrieving stones or other calculi deep within the body of the patient. A sheath 20 having a relatively small diameter may be advantageous for retrieving stones from restricted passageways within the human urinary tract. The sheath 20 may be relatively flexible to facilitate the retrieval of stones or other material located in complex, tortuous body structures.
[0035] An elongate member 18 lies partially within the sheath 20. Elongate member 18 is preferably a wire formed of a biocompatible material such as stainless steel, cobalt, chromium, nickel, titanium, nitinol, or other suitable metal. The member 18 may be in the form of a flexible shaft, coil, cable, or wire.
[0036] The elongate member 18 extends proximally from the end effector 16 into the handle body 12. In one configuration, the proximal end of the elongate member 18 is connected to a movable internal portion of the handle 12, such that movement of the internal portion will move the end effector 16 relative to sheath 20 between expanded and collapsed states. In another configuration not shown, the proximal end of the sheath 20 may connect to a movable internal portion of the handle body 12, such that movement of the movable internal portion will extend the sheath 20 over the end effector 16 and thereby collapse the end effector 16.
[0037] The end effector 16 may comprise a basket, grasper, snare, claw, or any other retrieval or grasping mechanism. The end effector 16 may also comprise any other mechanism for performing an operation in a body and may be suitable for urological, endoscopic, or other like procedures.
[0038]
[0039] The proximal end of the elongate member 18 extends into the handle 12. Handle 12 and sheath 20 and elongate member 18 extend along the same longitudinal axis L-L of the device, as shown in
[0040] Handle 12 further includes a thumb wheel 28, configured to lie where the thumb is located when a hand grips the device 10, and a rotation knob 32, configured to lie where a finger is located on the device 10. Handle 12 is gripped in the palm of a hand. With a single hand, an operator can grip the handle 12, turn the thumb wheel 28, and actuate the rotation knob 32. As shown in
[0041] A thumb or finger turns the thumb wheel 28 to extend and retract the sheath 20 along its longitudinal axis. The thumb wheel 28 is a disc or gear with teeth or ridges 29 along its circumference. Most of the thumb wheel 28 lies within the handle 12 between the middle and the distal end 24 of the handle 12. Part of the wheel 28 is exposed to allow the operator to grip the edge of wheel 28 with a thumb or finger to turn the wheel 28. The thumb wheel teeth 29 improve finger or thumb grip on the wheel 28 and engage the teeth 31 on a rack gear 30. Other textured or rough surfaces may line the circumference of thumb wheel 28 so that the wheel 28 can engage rack gear 30.
[0042] The thumb wheel 28 is held in a default position by a biasing system, such as one or more springs that hold the thumb wheel teeth 29 in place so they will not engage the rack gear teeth 31 when the thumb wheel 28 is in the default position. When the thumb wheel 28 is depressed, the biasing system (not shown) yields and the thumb wheel teeth 29 engage the rack gear teeth 31.
[0043] The handle 12 includes a locking mechanism to lock the thumb wheel 28 in place when not depressed. As shown in
[0044] In this embodiment, the operator activates mechanisms on the handle to move the sheath 20 toward the distal end of the device 10 relative to elongate member 18 by turning the top of the thumb wheel 28 toward the proximal end of the handle 22; or clockwise in
[0045] The rack gear 30 includes a long element or rack that lies within the handle 12. The long element of the rack gear 30 is connected to the sheath 20 and is configured to move along the longitudinal axis L-L of the handle 12. Teeth 29 on the edges of thumb wheel 28 engage or interfit with teeth 31 on the long element of the rack gear 30, thereby causing movement of the rack gear when the thumb wheel 28 turns.
[0046] Engaging thumb wheel 28 telescopes a stiffening cannula 19 into rack gear 30 and sheath 20, providing the required support to push and pull gear 30 over the elongate member 18 without need for and additional, overlapping cannula. Telescoping cannula 34 prevents existing cannula 19 from protruding into the proximal end of the sheath 20, common in prior handles. The sheath 20 extends into at least the distal end of a lumen of rack gear 30 and fixedly connects to rack gear 30.
[0047] In other embodiments, the thumb wheel may utilize a toggle lock or any other locking system to keep the wheel from moving inadvertently. Other embodiments may also place the thumb wheel in a position for actuation by a finger instead of a thumb. The rack gear system may be configured such that turning the thumb wheel toward the proximal end of the handle moves the rack gear and sheath toward the proximal end of the handle. The system may also be configured to restrict the thumb wheel and rack gear to certain positions or favor certain positions over others by altering the design of the surface of the thumb wheel or the surface of the rack gear.
[0048] Movement of the rack gear 30 along longitudinal axis L-L causes movement of sheath 20 along the same axis, in the same direction. The movement of the sheath 20 relative to the elongate member 18 along the L-L axis in the direction of the end effector 16 eventually situates the end effector 16 in its collapsed state, not shown here. Movement of the sheath 20 in the direction of the proximal end of the handle 12 eventually situates the end effector 16 in its expanded or unfurled state.
[0049] As shown in the
[0050] As shown in detail in the cross-sectional view of
[0051] By turning the right edge of the rotation knob toward the bottom of the device, or clockwise in
[0052] Other embodiments may place the rotation knob where it could be operated by a thumb or another part of the hand instead of a finger.
[0053] Using the thumb wheel 28 and the rotation knob 32 on the handle 12 of this embodiment of the medical device 10, a physician can manipulate or position the sheath 20 relative to the end effector with a single hand by rolling the thumb wheel 28 with a thumb or finger, thereby moving the sheath 20 proximally or distally; and by actuating the rotation knob 32 with a different finger, thereby rotating the elongate member 18 and the end effector 16 about their longitudinal axes.
[0054] Embodiments of invention enables medical devices whose handles are lighter and smaller than current handles in the art.
[0055]
[0056] The medical device 100 includes a handle 102, a sheath 118, an elongate member 110, and an end effector 106. Sheath 118 may be flexible and includes an internal lumen for receiving the distal end effector 106 at the distal end of member 110. The end effector 106 and sheath 118 are moveable relative to each other in order to achieve a first collapsed state of the end effector 106 in which the end effector 106 is collapsed within the lumen of the distal end of the sheath 118 and a second state in which the end effector 106 extends from the distal end of the sheath 118 and expands. The end effector 106 may comprise any of the mechanisms described in the description of the end effector of the embodiment above.
[0057] Handle 102 of medical device 100, sheath 118, and elongate member 110 extend along the same longitudinal axis L-L. Handle 102 includes an elongated handle body, including a proximal handle end 130 and a distal handle end 104. The end effector 106 extends distally from elongate member 110 disposed within the lumen of the sheath 118. The elongate member 110 extends proximally from the end effector 106 into the handle 102 and may be in the form of a flexible shaft, coil, cable, or wire. In this embodiment, the proximal end of the elongate member 110 is connected to the proximal end 130 of the handle 102.
[0058] Handle 102 further includes a thumb gear 114 with teeth 116, the exposed portion of the gear 114 positioned where the thumb lies when a hand grips the device 100. Handle 102 also includes a rotation knob 124, close to the proximal end of the handle and connected to a pinch vise 126. In this embodiment, the rotation knob 124 is positioned much nearer the proximal-most end of the handle 102, and closer to the outer edge of the hand gripping the handle, where the last two fingers may be best positioned to rotate the knob 124. The operator holds the handle 102 in the palm of the hand; and with a single hand, the operator can grip the handle 102, turn the thumb wheel 114, and actuate the rotation knob 124. As in the earlier embodiment, the thumb wheel 114 rotates about an axis perpendicular to the longitudinal axis of the handle 102; and the rotation knob 124 rotates about an axis parallel to the longitudinal axis of the handle 102.
[0059] In this embodiment, the thumb wheel 114 operates similarly to the thumb wheel in the embodiment above. Lever springs 112 hold the wheel 114 in a default position such that the thumb wheel teeth 116 do not engage the rack gear teeth 122 in the default position. One spring 112 exerts an upward force on a thumb wheel tooth 116, transferring torque in one direction of the thumb wheel 114. Another spring exerts an upward force on a tooth at another section of the thumb wheel 114, also transferring torque in the opposite direction of the first spring 112. As a result, the force of the springs 112 lifts the thumb wheel 114 upwards from the rack, but does not turn thumb wheel 114. This spring mechanism also acts as a locking mechanism, holding the thumb wheel in place when not depressed.
[0060] As in the embodiment of
[0061]
[0062] As shown in
[0063] The rack gear 120 attaches to sheath 118 inside the handle 102. Movement of the rack gear 120 along the longitudinal axis of the handle causes movement of sheath 118 along the same axis, in the same direction. Movement of the sheath 118 in the direction of the proximal end 130 of the handle 102 eventually situates the end effector 106 in its open configuration. Movement of the sheath 118 in the opposite direction toward the distal end eventually situates the end effector 106 in its collapsed position within the sheath 118.
[0064] The rotation knob 124 lies near the proximal end of the handle 102. In this embodiment, the rotation knob 124 is external to the handle body and can be actuated by a thumb or fingers at any point around the circumference of the handle 102. The rotation knob 124 is integrally formed with a pinch vise 126, and rotating the knob 124 provides torque to rotate the pinch vise 126, which rotates the stiffening cannula 128 and elongate member 110. As the pinch vise 126 rotates with the knob 124, it turns the end effector 106 about the longitudinal axis of the device in the same direction.
[0065] The configuration of medical devices 10 and 100 according to the invention allows a single user to operate an endoscope with one hand and actuate the medical device with the other hand.
[0066] The operation of devices 10 and 100 is substantially the same and will be described with reference to device 10 of
[0067] When appropriate, the operator depresses the thumb wheel 28 to engage the rack gear; then, the operator turns the thumb wheel 28 on the handle 12 with the thumb of the same hand that grips the handle 12. By turning the top of the thumb wheel 28 toward the distal end of the device, the operator moves the sheath proximally relative to the elongate member 18 and the end effector 16, transitioning the end effector 16 to its expanded state. With the end effector in its expanded state, the operator can capture, contact, or manipulate the material as needed. When the target material is in range, the operator can release the thumb wheel 28, locking the position of the wheel 28 and the sheath 20. Then, if needed, the operator turns the rotation knob 32, causing the elongate member 18 and end effector 16 to rotate about the longitudinal axis L-L of the device, thereby properly positioning the end effector 16 in relation to the material. Turning knob 32 can be performed with a finger of the same hand that is holding handle 12, without repositioning that hand after turning wheel 28. Then, by depressing and turning the top of the thumb wheel 28 toward the proximal end of the device, the operator moves the sheath 20 distally in relation to the end effector 16, moving the end effector towards its collapsed state. The operator thereby grabs, envelopes, snares, or captures the material and can further manipulate it by turning the thumb wheel 28 or the rotation knob 32.
[0068] Though shown with a retrieval device (and particularly a basket), the handles described above can be used with any other medical devices which require longitudinal positioning or rotation of medical devices at a treatment site. The reference to the use of a retrieval device is used as an example and is not intended to limit the scope of the invention.
[0069] Other embodiments of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the invention disclosed herein. It is intended that the specification and examples be considered as exemplary only. The following embodiments are exemplary.