MEDICAL DEVICE POSITIONING SYSTEM
20220175220 · 2022-06-09
Assignee
Inventors
Cpc classification
A61M25/0147
HUMAN NECESSITIES
A61B1/0052
HUMAN NECESSITIES
A61B1/313
HUMAN NECESSITIES
International classification
A61B1/00
HUMAN NECESSITIES
A61B1/273
HUMAN NECESSITIES
A61B1/313
HUMAN NECESSITIES
Abstract
Embodiments of the invention include a medical device for accessing a patient's body portion and used for diagnosis and treatment of medical conditions. Embodiments of the invention may include a particular endoscopic positioning mechanism for placing an endoscope and an additional treatment device within desired body portions in order to assist in diagnosis and treatment of anatomical diseases and disorders. In particular, a medical device according to an embodiment of the invention may include an outer flexible tube and a positioning mechanism configured for rotating one portion of the flexible tube relative to another portion of the flexible tube.
Claims
1-52. (canceled)
53. An endoscopic device comprising: a shaft comprising a proximal section and a distal section, the distal section comprising: a lumen that extends to a distal opening; a torque transfer mechanism that includes a torque transfer element; and a cavity extending distal to the opening; and a rotatable coupling between the proximal section and the distal section; wherein the cavity receives the torque transfer element, and rotation of the torque transfer element drives rotation of the distal section relative to the proximal section.
54. The device of claim 53, wherein the torque transfer mechanism further comprises a gear system.
55. The device of claim 54, wherein the torque transfer element terminates at the gear system.
56. The device of claim 54, wherein the gear system comprises two gears including a pinion gear, the torque transfer element being coupled to the pinion gear.
57. The device of claim 53, wherein the lumen extends through the proximal section and the distal section.
58. The device of claim 53, wherein the cavity extends in an arc.
59. The device of claim 53, wherein the distal opening is a side-facing opening.
60. The device of claim 53, wherein the cavity is configured to limit rotation of the distal section relative to the proximal section to less than 360 degrees.
61. An endoscopic device comprising: a shaft comprising a proximal section and a distal section, the distal section comprising: a lumen extending through the proximal section and the distal section, the lumen terminating at a distal opening; and a torque transfer element; and a rotatable coupling between the proximal section and the distal section; wherein the torque transfer element extends distal to the rotatable coupling and is configured to drive rotation of the distal section relative to the proximal section.
62. The device of claim 61, wherein the opening is a side-facing opening or a forward-facing opening.
63. The device of claim 61, wherein the device further comprises a gear system coupled to the torque transfer element.
64. The device of claim 63, wherein the gear system comprises a pinion gear, or a sun gear and one or more planet gears.
65. The device of claim 64, wherein the gear system comprises a sun gear that includes a central opening in communication with the lumen.
66. The device of claim 61, wherein the cavity extends in an arc.
67. The device of claim 61, wherein the cavity has boundaries that limit rotation of the distal section relative to the proximal section.
68. An endoscopic device comprising: a shaft comprising a proximal section and a distal section, the distal section comprising: a lumen that extends to a distal opening; a torque transfer element that extends distal to the distal opening; and a rotatable coupling between the proximal section and the distal section; wherein rotation of the torque transfer element drives rotation of the distal section relative to the proximal section.
69. The device of claim 68, wherein the lumen receives visualization and illumination components.
70. The device of claim 68, wherein the device further comprises two gears including a pinion gear.
71. The device of claim 68, wherein the device further comprises a sun gear and one or more planet gears, the sun gear including an opening in communication with the lumen.
72. The device of claim 68, wherein the torque transfer element comprises a flexible drive shaft.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0018]
[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. The drawing figures of this application are intended to provide a general understanding of the working elements of the underlying system. Accordingly, unless explicitly stated, the figures do not represent a literal depiction of proportional dimensions or the precise locations for the illustrated inter-related components.
[0031] According to exemplary embodiments, the invention relates to a medical device for positioning a treatment device and/or viewing a patient's internal body portion. In embodiments that use a treatment device in an endoscopic medical procedure, the treatment device can be advanced through a working channel of an endoscope, including an endoscope specifically designed and/or sized for use with the treatment device, and into a tissue tract. For purposes of this disclosure, “treatment device” or “treatment instrument” includes, for example, any working medical device advanced through a working channel of an endoscope and for use during an endoscopic procedure. Exemplary treatment instruments include, but are not limited to, guide wires, cutting or grasping forceps, biopsy devices, snare loops, injection needles, cutting blades, scissors, retractable baskets, retrieval devices, ablation and/or electrophysiology catheters, stent placement devices, surgical stapling devices, and balloon catheters.
[0032]
[0033]
[0034] Through this arrangement (e.g., a joint between portions 24 and 26) rotating portion 24 is configured for rotation relative to proximal portion 26. That rotation is about a longitudinal axis of endoscope 10′ and tube 12′. Joint 22 should be configured in a fluid-tight arrangement in order to prevent contamination and corrosion of the internal components of endoscope 10′ due to contact within a patient's internal body fluids.
[0035] Other mechanisms may be used for rotating portion 24 relative to portion 26. For example, a number of pull wires wrapped around a spool could rotate portion 24. Additional examples include, but are not limited to electronic actuators, such as a stepper motor, cam drivers, a worm gear arrangement, or a pull wire system comprising a pulley type arrangement.
[0036] Although not depicted in the accompanying drawing figures, it is contemplated that the endoscope 10′ may include known positioning structure for navigating the endoscope 10′ and a treatment instrument through the tortuous pathways of a patient's internal body portion. For example, endoscope 10′ may include pull wires for effectuating deflection during positioning and an elevator device for altering the angle at which a treatment instrument exits the endoscope 10′.
[0037] The proximal portion 26 of endoscope 10′ includes a central lumen 28 within the endoscope 10′, which extends from the proximal end of the endoscope 10′ and terminates at the distal end of proximal portion 26. Rotating portion 24 includes a lumen 30 that connects with central lumen 28 of proximal portion 26. Lumen 30 extends distally within rotating portion 24 and curves to extend laterally, terminating at a side facing operation window 32. As seen in
[0038] Lumens 28 and 30 of endoscope 10′ are configured to receive visualization components, such as, for example, known endoscopic imaging elements comprising illumination devices and fiber optic viewing elements for the transfer of images to the proximal end of the endoscope as known in the art. A portion of lumens 28 and 30 may further comprise an endoscopic working channel for receiving and guiding a treatment instrument therethrough. In such embodiments, joint 22 will include a hole 29 that connects lumens 28 and 30 during positioning of endoscope 10′ and rotation of rotating portion 24 relative to proximal portion 26. In addition, a portion of operation window 32 can include a working channel exit port (see item 56 of
[0039] In some embodiments, the treatment instrument delivered through this endoscope could be designed for increased flexibility of rotation at a distal end portion, thereby accommodating rotation of the rotating portion 24 of the endoscope 10′. For example, a distal end portion of a treatment instrument could be provided with a rotatable or twistable component.
[0040] As seen in
[0041] A torque transfer element, such as, for example, flexible drive shaft 40 is provided within the rotation component lumen 34 and extends distally through cavity 36 terminating at force transfer region 38. The proximal end of drive shaft 40 is connected to any known type of positioning control mechanism at a handle at the proximal end of endoscope 10′ to effectuate rotation of flexible drive shaft 40.
[0042]
[0043] Since lumens 28 and 30 of endoscope 10′ are configured to receive visualization components and at least one treatment instrument therein, complete rotation of rotating portion 24 could hinder the proper operation of those components. For example, multiple rotations of rotating portion 24 about the longitudinal axis of tube 12′ could damage the internal components due to tangling of the elongated components and extreme amounts of torsion within the components housed in lumens 28 and 30. In order to avoid those possible consequences of excessive turning, permitting rotation in an amount less than a full 360 degrees is preferred. Accordingly, certain structure could be provided within the internal components of endoscope 10′ in order to prevent rotation beyond a particular predetermined angular threshold.
[0044]
[0045] Arc shaped rotation component cavity 36 is feed to exhibit a constant radius of curvature. Therefore, every point along the arc shaped rotation component cavity 36 is equidistant from the center of tube 12′ of endoscope 10′. Accordingly, when the flexible drive shaft 40 is rotated, first and second ends 52 and 54 of arc shaped rotation component cavity 36 provide a boundary limiting the extent to which rotating portion 24 is permitted to rotate relative to proximal portion 26. In order to prevent an excessive torque transmission or excessive torsion stored along the flexible drive shaft 10′, markers, or any other type of indicia, can be provided at the positioning control mechanism to depict the allowable limits of rotation.
[0046] With reference to
[0047] Other mechanisms may be used for rotating portion 24 relative to portion 26. For example, a planetary gear system can be used to permit relative rotation of two endoscope portions.
[0048] In one embodiment, a central portion of the planetary gear arrangement 90 includes a central aperture 29′ connecting lumens 28 and 30, as described above, during positioning of an endoscope and rotation of rotating portion 24 relative to proximal portion 26, for example. Accordingly, visualization components and at least one treatment instrument extend through aperture 29′ when used in a system comprised of joint 22′.
[0049] With reference to
[0050] In the planetary gear system 90, rotation is transmitted from one element to another in the gear network by grounding, also called locking, one element (i.e. either the sun gear 93, the ring gear 97, or the carrier 98) to a stationary component of structure. In an endoscope that includes joint 22′ for effectuating rotation of a rotating portion 24 relative to a proximal portion 26, the locked component of planetary gear system 90 will be connected, or otherwise held stationary relative to, the proximal portion 26 of the underlying endoscope.
[0051] In one embodiment, carrier 98 is grounded by virtue of connection to a proximal portion 26 of the underlying endoscope. As such, carrier 98 will not rotate relative to the proximal portion 26. In such an arrangement, rotation of rotating portion 24 can be effectuated through rotation of sun gear 92 relative to carrier 98. For example, due to the engagement of gear teeth 93, 95, and 96, rotation of sun gear 92 in a first direction results in concurrent rotation of the planet gears 94 and, in turn, ring gear 97, in a second rotational direction opposite the first direction.
[0052] Rotation of sun gear 93 relative to carrier 98 can be effectuated through any known torque transfer element. For example, a hollow, flexible drive shaft (not shown) can be provided within the proximal portion 26 of the underlying endoscope. The proximal end of the drive shaft is then connected to any known type of positioning control mechanism at a handle at the proximal end of the underlying endoscope. Accordingly, in such an arrangement a user can control rotation of rotating portion 24 through actuation of a positioning mechanism that in turn results in rotation of sun gear 92.
[0053] In another embodiment, sun gear 92 is grounded by virtue of connection to a proximal portion 26 of the underlying endoscope. As such, sun gear 92 will not rotate relative to the proximal portion 26. In such an arrangement, rotation of rotating portion 24 can be effectuated through rotation of carrier 98 relative to sun gear 92. For example, due to the engagement of gear teeth 93, 95, and 96, rotation of carrier 98 in a first direction results in rotation of planet gears 94 about the locked sun gear 92. The movement and rotation of planet gears 94 also results in rotation of ring gear 97 in the same direction as carrier 98.
[0054] Just as described above with regard to an arrangement where sun gear 92 is rotated, rotation of carrier 98 can be effectuated through any known torque transfer element. For example, a hollow, flexible drive shaft (not shown) can be provided within the proximal portion 26 of the underlying endoscope. The proximal end of the drive shaft is then connected to any known type of positioning control mechanism at a handle at the proximal end of the underlying endoscope. Accordingly, in such an arrangement, a user can control rotation of rotating portion 24 through actuation of a positioning mechanism that in turn results in rotation of carrier 98.
[0055]
[0056] Item 26′ depicts a flexible proximal endoscope portion 26′. Proximal portion 26′ can be hollow and configured for rotationally receiving the reduced diameter portion 102 within a distal portion thereof. As seen in
[0057]
[0058] The relation between the engagement pin 104 and engagement section 109 may be such that the pin 104 is selectively or otherwise releasable from, and in certain embodiments re-engagable with, the engagement section 109. The engagement between pin 104 and engagement section 109 may be achieved, for example, by a male/female connection in which a portion of pin 104 is inserted and received within the engagement section 109, which is of a reduced size configured to releasably receive the pin 104 by virtue of an interference fit. The engagement may be realized, for example, by a ball and socket type connection, a friction fit engagement, a screw-like configuration or any other releasable engagement mechanisms known to one having ordinary skill in the art.
[0059] Rotation of rotating portion 24′ can be effectuated through controlled movement of engagement pin 104 within both linear groove 108 and helical groove 106. To initiate rotation, the rotating portion 24′ must be moved relative to the proximal portion 26′ with an initial forward displacement force of a magnitude great enough to overcome the force with which engagement section 109 holds pin 104. Rotating portion 24′ can be displaced relative to the proximal portion 26′ with any known force transfer element. Examples of suitable force transfer elements include, but are not limited to, push wires, stylets, cam drivers, stepper motors, a pull wire arrangement where a pulley type system changes a proximal pulling force into a distally directed one, and/or piezoelectric transducers provided within the proximal portion 26′ of the underlying endoscope. When rotation of rotating portion 24′ is desired, an operator can first linearly displace rotating portion 24′ relative to proximal portion 26′ such that engagement pin 104 moves along linear groove 108 and into the helical groove 106.
[0060] As seen in
[0061] While an arrangement comprised of an engagement pin 104 and helical groove 106 is described for effectuating rotation of rotating portion 24′, other configurations are contemplated. For example, a dovetail protrusion and complementary groove could also be used. Furthermore, the helical groove 106 and pin 104 could be reversed such that a pin 104, or other protrusion, is formed on an interior of proximal portion 26′ and with a helical groove formed on the reduced diameter portion 102 of rotating portion 24′.
[0062] In an alternative arrangement, the location of groove 106 and engagement pin 104 can be reversed. For example, helical groove 106 could be provided along an exterior surface of reduced diameter portion 102 of rotating portion 24′ and engagement pin 104 could be provided along an internal surface of proximal portion 26′. In addition, the rotating portion 24′ and proximal portion 26′ could be connected and rotatable relative to each other through any type of mating thread arrangement.
[0063] In the particular embodiments of
[0064] In all embodiments, it is to be understood that the rotation of one endoscope portion relative to another should protected from contamination by structure providing a fluid tight arrangement. In addition, the rotation of one portion relative to another can be facilitated by virtue of any lubrication element and or friction reducing structure. For example, a particular lubricious coating can be provided along the surfaces where repeated engagement or moving parts takes place.
[0065]
[0066] During a medical procedure, the exit port 56 along the distal portion of endoscope 10′ can be repeatedly repositioned at different longitudinal locations within a patient's body. Treatment instrument 60 can then be deployed at each different location and precisely positioned to access a desired treatment site at that location. Angular adjustment of the orientation of treatment instrument 60 as it extends from endoscope 10′ at consecutive treatment locations can reduce internal tissue trauma resulting from repeated rotation of an entire endoscope during a treatment procedure. Furthermore, precise manipulation of a treatment device 60 can result in shortened treatment procedures by reducing the amount of time necessary to effectuate proper position of the treatment device 60.
[0067] In addition to the above-described medical device rotation mechanisms, the incorporation of additional positioning mechanisms, including various positioning controls to effectuate bending of the flexible outer tube 12′ during a medical procedure, are within the scope of this invention. 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, with a true scope and spirit of the invention being indicated by the following claims.