Medical device rotation assembly and method of use

Abstract

The medical device includes a sheath, an instrument disposed within the sheath and movable relative to the sheath, and a handle including a rotation assembly that rotates the instrument relative to the sheath in response to rotation of the rotation assembly relative to a portion of the handle, the rotation assembly rotating the instrument relative to the sheath in predefined angular intervals and preventing movement at each angular interval.

Description

[Technical Field]

[0001] FIELD OF THE INVENTION The present invention relates to medical systems, devices and associated methods, and more particularly to systems, devices and associated methods for determining and controlling the position of one or more medical devices within a patient's body during a procedure. [Background technology]

[0002] Technological developments are enabling users of medical systems, devices, and methods to perform increasingly complex procedures on subjects. One challenge in the field of minimally invasive surgery, such as endoscopy, laparoscopy, and thoracoscopy, relates to providing control of medical devices with respect to the orientation and position of such devices during a procedure. Placement of medical devices within a patient's body can be difficult. Furthermore, maintaining a desired position of a device can be unreliable. Restrictions on medical devices that facilitate access of other devices within a patient's body for placement can lengthen the procedure, limit the effectiveness of the procedure, or result in patient injury due to device failure or breakage. Summary of the Invention [Means for solving the problem]

[0003] The present invention relates to systems, devices, and methods for accessing a target treatment site with a medical device having features that facilitate positioning of the medical device. Each of the aspects disclosed herein may include one or more of the features described in connection with any of the other disclosed aspects.

[0004] According to one example, a medical device includes a sheath, an instrument disposed within and movable relative to the sheath, and a handle including a rotation assembly that rotates the instrument relative to the sheath in response to rotation of the rotation assembly relative to a portion of the handle, the rotation assembly rotating the instrument relative to the sheath at predefined angular intervals and preventing movement at each angular interval.

[0005] Any of the medical devices described herein may have any of the following features: The rotating assembly maintains the instrument in at least one of the predefined angular intervals to secure the instrument relative to the sheath; The rotating assembly releases the instrument from at least one of the predefined angular intervals in response to a predetermined rotational force applied to the rotating assembly; The rotating assembly generates at least one of tactile feedback, audible feedback, or visual feedback when rotating between the predefined angular intervals; The rotating assembly includes a shaft having a plurality of ridges circumferentially alternating with a plurality of recesses; The handle includes one or more arms, each of which engages the plurality of ridges and the plurality of recesses; The rotating assembly prevents rotational movement between the rotating assembly and a portion of the handle when a first of the one or more arms is disposed within a first of the plurality of recesses. While the first arm is disposed within the first recess, a rotational force is applied to the rotating assembly relative to the portion of the handle, causing the first arm to exit the first recess and be disposed within a second recess circumferentially adjacent to the first recess. The one or more arms include a plurality of arms extending radially inward within the lumen of the handle. Each of the plurality of arms is biased from each of the other arms. The rotating assembly includes a plurality of recesses or holes disposed on an outer surface of the rotating assembly. The handle includes one or more detents configured to engage with the plurality of recesses or holes. The rotating assembly prevents rotational movement between the rotating assembly and the portion of the handle when a first of the one or more detents is disposed within a first of the plurality of recesses or holes. The first detent includes a compressible portion. When a rotational force is applied to the rotating assembly relative to the portion of the handle while the first detent is disposed within the first recess or bore, the first detent compresses and moves out of the first recess, disposing the first detent within a second recess or bore circumferentially adjacent the first recess or bore. The rotating assembly includes a distally facing flange having a protrusion extending distally from the distally facing flange.The handle includes a proximally facing flange having a plurality of circumferentially spaced recesses or holes. A projection is configured to be received by each of the plurality of recesses or apertures, and when the projection is received by one of the plurality of recesses or holes, rotational movement between the rotating member and that portion of the handle is prevented. The medical device further includes a deformable member disposed proximal to the distally facing flange. The deformable member biases the distally facing flange toward the proximal-facing flange. When a rotational force is applied to the rotating assembly relative to the portion of the handle while the projection is disposed within a first recess or aperture, the deformable member compresses, causing the projection to exit the first recess or hole and be positioned within a second recess or hole circumferentially adjacent to the first recess or hole. The projection includes a compressible portion. When a rotational force is applied to the rotating assembly relative to the portion of the handle while the protrusion is disposed within the first recess or hole, the protrusion is compressed and moves out of the first recess or hole, disposing the protrusion in a second recess or hole circumferentially adjacent to the first recess or hole. The handle includes a plurality of protrusions and a plurality of recesses. The plurality of protrusions and the plurality of recesses alternate with one another. The rotating assembly includes a compressible member. The compressible member is configured to be received by each of the plurality of recesses, and when the protrusion is received by one of the plurality of recesses, rotational movement between the rotating assembly and the portion of the handle is prevented. The rotating assembly includes a flange, the flange having a slot surrounded by the flange. The compressible member includes a periphery of the flange that defines at least a portion of the slot. When a rotational force is applied to the rotating assembly relative to that portion of the handle while the compressible member is disposed within the first recess, the compressible member is compressed radially inward, reducing the volume of the slot, causing the compressible member to exit the first recess and dispose within a second recess circumferentially adjacent to the first recess or hole.

[0006] According to another example, a medical device includes a handle including a rotation assembly movable relative to a remainder of the handle, a sheath extending from the handle, and an instrument disposed within the sheath and movable relative to the sheath. The rotation assembly rotates the instrument relative to the sheath to a plurality of predefined angular positions in response to rotation of the rotation assembly relative to at least a portion of the handle. The rotation assembly provides at least one of tactile feedback or audible feedback to a user when rotating from one of the plurality of predefined angular positions to another of the plurality of predefined angular positions.

[0007] Any of the medical devices described herein can have any of the following features: The rotating assembly maintains the instrument in at least one of predefined angular positions to secure the instrument relative to the sheath. The rotating assembly releases the instrument from at least one of the predefined angular positions in response to a predetermined rotational force applied to the rotating assembly. The rotating assembly generates at least one of tactile feedback, audible feedback, or visual feedback when rotating between the predefined angular positions. The rotating assembly includes a shaft having a plurality of recesses and a plurality of circumferentially alternating ridges. The handle includes one or more arms. Each of the one or more arms engages with the plurality of ridges and the plurality of recesses. The rotating assembly prevents rotational movement between the rotating assembly and a portion of the handle when a first of the one or more arms is positioned within a first of the plurality of recesses.

[0008] According to another example, a method for rotating an instrument relative to a sheath to a plurality of predefined angular positions includes rotating an assembly relative to a handle away from a first predefined angular position to a second predefined angular position. The method includes generating a first index feedback at the rotating assembly in response to rotating the rotating assembly out of the first predefined angular interval, and generating a second index feedback at the rotating assembly in response to rotating the rotating assembly to the second predefined angular position. The first predefined angular position is configured to maintain the instrument at a first fixed orientation relative to the sheath, and the second predefined angular position is configured to maintain the instrument at a second fixed orientation relative to the sheath.

[0009] Both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary embodiments of the invention and, together with the description, serve to explain the principles of the invention. [Brief explanation of the drawings]

[0010] [Figure 1A] 1 is a side view of an exemplary medical system including a medical device and a medical instrument, the medical device having a rotating assembly, in accordance with aspects of the present invention; [Figure 1B] 2 is a side cross-sectional view of the medical device of FIG. 1, the medical device including a needle in an extended state, according to an embodiment of the present invention. [Figure 1C] 2 is a side cross-sectional view of the medical device of FIG. 1, the medical device including a cannula in an extended state, according to an embodiment of the present invention. [Figure 2] 2 is an exploded view of the rotating assembly of FIG. 1 according to an embodiment of the present invention. [Figure 3] 2 is a bottom view of the rotating assembly of FIG. 1 according to an embodiment of the present invention. [Figure 4] 2 is an exploded view illustrating another exemplary rotation assembly of the medical device of FIG. 1, according to an embodiment of the present invention. [Figure 5] 2 is an exploded view illustrating another exemplary rotation assembly of the medical device of FIG. 1, according to an embodiment of the present invention. [Figure 6] 6 is a cross-sectional view of the rotating assembly of FIG. 5, according to an embodiment of the present invention. [Figure 7] 2 is a perspective view of another exemplary rotation assembly of the medical device of FIG. 1, according to an embodiment of the present invention. [Figure 8] 8 is a side view of the rotating assembly of FIG. 7, according to an embodiment of the present invention. [Figure 9] 9 is a cross-sectional view of the rotating assembly of FIG. 8, according to an embodiment of the present invention. [Figure 10] 2 is a side view of another exemplary rotation assembly of the medical device of FIG. 1, according to an embodiment of the present invention. [Figure 11] 11 is a cross-sectional view of the rotating assembly of FIG. 10, according to an embodiment of the present invention. [Figure 12] 2 is an exploded side view of another rotating assembly illustrating the medical device of FIG. 1 according to an embodiment of the present invention. [Figure 13] FIG. 13 is a bottom view of the rotating assembly of FIG. 12, according to an embodiment of the present invention. [Figure 14] 13 is a cross-sectional view of the rotating assembly of FIG. 12, according to an embodiment of the present invention. DETAILED DESCRIPTION OF THE INVENTION

[0011] The present invention includes systems, devices, and methods for determining the position and / or orientation of multiple components of a medical device at a target site within the body. Reference will now be made in detail to embodiments of the invention, examples of which are illustrated in the accompanying drawings. Wherever possible, the same or similar reference numerals will be used throughout the drawings to refer to the same or similar parts. The term "distal" refers to the portion of the device furthest from the user during introduction into a patient's body. In contrast, the term "proximal" refers to the portion of the device closest to the user during placement within a patient's body. As used herein, the terms "comprises," "comprising," or any other variation thereof are intended to cover a non-exclusive inclusion, and a process, method, article, or device that includes or comprises a list of elements does not necessarily include only those elements, but may include other elements not expressly listed or inherent in such process, method, article, or device. The term "exemplary" is used to mean "example" rather than "ideal." As used herein, the terms "about," "substantially," and "approximately" refer to a range of values ​​within ±10% of the referenced value.

[0012] Examples of the present invention can facilitate control of the position and orientation of a medical instrument / device at a target treatment site by providing one or more mechanisms and / or assemblies that index the movement of the instrument / device. For example, some examples incorporate a rotation assembly on a medical device to selectively control or manipulate a component of the medical device received within the medical device to a plurality of predefined angular intervals / positions. The rotation assembly can be configured to control the radial orientation of the distal end of the medical device. The medical device includes a body defining a lumen configured to receive the medical device therein and a rotation assembly coupled to the medical device to move the medical device within the lumen of the body. The medical device includes a sheath and an instrument, such as an access cannula, disposed within the sheath. The rotation assembly is disposed external to the body and coupled to the medical instrument within the lumen, such that the position and orientation of the instrument can be indexed relative to the body in response to actuation of the rotation assembly. The rotation assembly of the medical device can further enable selective control or manipulation of a component of the medical device to a plurality of predefined angular intervals / positions.

[0013] Examples of the present invention relate to devices and methods for performing various medical procedures and treating portions of the large intestine (colon), small intestine, cecum, esophagus, any other portion of the digestive tract, and / or any other suitable patient anatomy (collectively referred to herein as the "target treatment site"). The devices and associated methods may be used laparoscopically or endoscopically, or in any other open or minimally invasive procedure, including thoracoscopic and ENT procedures. Reference will now be made in detail to the examples of the present invention described above and 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.

[0014] 1A shows a schematic diagram of an exemplary medical system 100 according to one example of the present invention. The medical system 100 includes a handle 110 and a medical device 170. In this example, the handle 110 includes an outer body 112 and an inner body 114, where the outer body 112 has a longitudinally extending length and defines a lumen sized, shaped, and configured to receive the inner body 114. As described in more detail herein, the outer body 112 moves relative to the inner body 114, and vice versa. The inner body 114 of the handle 110 has a longitudinally extending length and defines a lumen sized, shaped, and configured to receive the medical device 170.

[0015] In this example, the inner body 114 includes a rack portion having a plurality of teeth 116 extending along the outer surface of the inner body 114. The plurality of teeth 116 extend along at least a portion (up to the entire longitudinal length) of the inner body 114, corresponding to the range of movement of the outer body 112 relative to the inner body 114. Thus, the rack portion including the plurality of teeth 116 may extend along various suitable lengths and / or surfaces of the inner body 114 other than those shown and described herein without departing from the scope of the present invention. The handle 110 further includes a cap cover 120, an end cap 130, and a rotation assembly 150 disposed on and / or coupled to the outer body 112. The cap cover 120 of the handle 110 is disposed at the proximal end of the outer body 112 and, when secured to the proximal end, seals the lumen of the outer body 112 between the cap cover 120 and the outer body 112. The end cap 130 and the rotation assembly 150 extend from and / or are coupled to the cap cover 120. The cap cover 120, end cap 130, and rotation assembly 150 of the handle 110 may have a variety of suitable configurations and / or arrangements relative to each other and to the handle 110.

[0016] Additionally, the medical device 170 of the medical system 100 may include a catheter having a sheath 172, a cannula 176, and a needle 179. The cannula 176 is disposed within the lumen of the sheath 172, and the needle 179 is disposed within the lumen of the cannula 176 and extends at least partially outward from a tip 178 of the cannula 176. In this example, the position, orientation, and / or configuration of the needle 179 relative to the cannula 176 is fixed such that the distal end of the needle 179 is maintained in an extended position relative to the tip 178 of the cannula 176. The sheath 172 includes a tip 174 and has a longitudinal length defined by the distance between the tip 174 and a proximal end (not shown) of the sheath 172. The cannula 176 of the medical device 170 includes a tip 178 and has a longitudinal length defined by the distance between the tip 178 and a proximal end (not shown) of the cannula 176. As described in more detail herein, one or more components of the handle 110 are configured to position the medical device 170 relative to a target treatment site within a patient's body (e.g., within the patient's anatomy). For example, the medical device 170 is operable to pierce the target treatment site with the needle 179 as the needle 179 extends distally from the tip 174, as shown in FIG. 1B.

[0017] 1A , in some examples, medical instrument 170 is operable to facilitate access to a target treatment site for one or more instruments and / or devices, including and / or in addition to needle 179, via cannula 176. In this instance, upon removal of needle 179 from the lumen of cannula 176, one or more additional instruments and / or devices are received into the lumen of cannula 176 and extended outwardly and distally therefrom through tip 178 of cannula 176. In some examples, cannula 176 deforms in response to needle 179 being at least partially retracted from tip 178 of cannula 176. Additionally and / or alternatively, in another example, the cannula 176 deforms in response to the tip 178 of the cannula 176 extending outward, distally, from the tip 174 of the sheath 172, or conversely, in response to the tip 174 of the sheath 172 extending proximally relative to the tip 178 of the cannula 178.

[0018] 1C , the tip 178 of the cannula 176 conforms to a predetermined shape and / or configuration (e.g., a J-shape) when the needle 179 is omitted or the tip 178 is extended out of the lumen of the sheath 172. Retracting the needle 179 from the cannula 178 and / or extending the tip 178 from the lumen of the sheath 172 can remove the force applied to the cannula 176 and constrain the tip 178 to a certain shape and / or configuration. As described in further detail herein, the rotation assembly of the handle 110 controls the positioning of the J-shaped tip 178 of the cannula 176 during the procedure.

[0019] Additionally, in some examples, medical device 170 is operable to electrosurgically dilate a target treatment site via sheath 172. In this instance, sheath 172 comprises an electrosurgical sheath, and tip 174 comprises an electrosurgical tip. In other examples, medical device 170 may include a variety of suitable instruments, configurations, hypotubes, and / or components other than those shown and described herein. As an illustrative example, in some examples, medical device 170 may include an electrosurgical end (e.g., a cystotome needle) that omits tip 178, such as for delivering a stent during a procedure. In other examples, medical device 170 omits components configured for electrical activation.

[0020] Returning to FIG. 1A , the handle 110 further includes a first actuator 118 and a second actuator 119 disposed on the outer body 112. In this example, the first actuator 118 and the second actuator 119 are disposed on the outer body 112. The first actuator 118 is fixed to and / or coupled to the outer body 112 and moves the outer body 112 relative to the inner body 114 in response to actuation of the first actuator 118. In this example, the first actuator 118 is integral with the outer body 112 so as to form a unitary structure therewith. Additionally, the second actuator 119 is fixed to and / or coupled to the inner body 114 and moves the inner body 114 relative to the outer body 112 in response to actuation of the second actuator 119. For example, the second actuator 119 may be coupled to the inner body 114 through the outer body 112, such as via one or more openings and / or slots (not shown) formed through the outer body 112. The first actuator 118 and the second actuator 119 may be configured in accordance with at least a portion of the teachings of U.S. Patent Application No. 19-0411PV01 (Customer Reference No. 19-0411PV01, Attorney Docket No. 06530-1057-00600), entitled "Medical Device Locking Assemblies and Methods of Using the Same," filed on the same day as this application, the disclosure of which is incorporated herein by reference.

[0021] The handle 110 further includes a distal housing 160 disposed at the distal end of the inner body 114 opposite the outer body 112. The distal housing 160 of the handle 110 defines a lumen sized, shaped, and configured to receive one or more components of the handle 110 therethrough, such as at least a portion of the inner body 120, a medical device 170, etc. The distal housing 160 of the handle 110 further includes a housing tip 162 and a thread (fastener) 164. In this example, the housing tip 162 includes an opening sized and shaped to facilitate exit of the medical device 170 from the lumen of the distal housing 160 and / or the inner body 114. The thread 164 engages the outer surface of the inner body 114 within the lumen of the distal housing 160 to fixedly couple the inner body 114 to the distal housing 160. In this case, the screw 164 is movable (e.g., rotatable) relative to the distal housing 160 to selectively engage and disengage with the inner body 114 received within the distal housing 160. Various other suitable fastening elements, clamps, pins, etc. are contemplated without departing from the scope of the present invention.

[0022] The following description provides various examples of the cap cover 120, end cap 130, and rotation assembly 150 shown and described above. Each of the exemplary cap cover 120, end cap 130, and / or rotation assembly 150 referred to herein may be used in conjunction with the handle 110 and medical instrument 170 described above in any of the various procedures described herein. Accordingly, any of the cap cover 120, end cap 130, and / or rotation assembly 150 shown and described herein (see FIGS. 2-12) may be readily incorporated into the medical system 100 described in detail above and illustrated in FIG. 1A.

[0023] 2, an example of a cap cover 120A, end cap 130A, and rotation assembly 150A is shown and described herein. In this example, cap cover 120A includes a body 122A defined by a distal opening 124A and a proximal opening 126A. As described further herein, distal opening 124A of body 122A is sized, shaped, and configured to at least partially receive end cap 130A and / or rotation assembly 150A therein. Furthermore, proximal opening 126A of body 122A is sized, shaped, and configured to receive rotation assembly 150A therein. Body 122A of cap cover 120A further includes a recess 125A formed along a sidewall of body 122A between distal opening 124A and proximal opening 126A. As described further herein, recess 125A is sized and shaped to receive one or more components of end cap 130A (e.g., pin housing 134A) when cap cover 120A is attached to end cap 130A. Cap cover 120A includes one or more slots 127A formed along one or more side walls of body 122A. One or more slots 127A may extend along an axis transverse (e.g., generally perpendicular) to the longitudinal axis of handle 110. Cap cover 120A includes a pair of slots 127A formed through a pair of side walls of body 122A and positioned adjacent proximal opening 126A.

[0024] Additionally, the cap cover 120A includes one or more holes 128A formed along one or more side walls of the body 122A. The cap cover 120A includes a pair of holes 128A formed through a pair of side walls of the body 122A and positioned adjacent to the distal opening 124A. In this example, the pair of slots 127A and the pair of holes 128A of the cap cover 120A are formed along the same side wall of the body 122A; however, the slots 127A and / or holes 128A may be positioned along various other walls and / or surfaces of the body 122A of the cap cover 120A without departing from the scope of the present invention. For example, the same side wall of the body 122A may include the slots 127A and holes 128A. In other examples, the cap cover 120A may include additional and / or fewer slots 127A and holes 128A than those shown and described herein.

[0025] 2, the end cap 130A includes a central body 132A and a pin housing 134A extending radially outward from the central body 132A. The pin housing 134A is transverse (e.g., generally perpendicular) to the longitudinal axis of the central body 132A of the end cap 130A. As described above, the pin housing 134A extends outward from the body 122A of the end cap 130A through the recess 125A when the end cap 130A is coupled to the cap cover 120A. The pin housing 134A of the end cap 130A includes an active pin (connector) 136A disposed therein such that the pin housing 134A surrounds the active pin 136A. In this example, the active pin 136A is operable to establish communication with the medical device 170 when the end cap 130A is coupled to the outer body 112 and the medical device 170 is disposed within the inner body 120. For example, active pin 136A may be communicatively coupled to one or more components of medical instrument 170, such as sheath 172 (e.g., an electrosurgical sheath comprising an electrically conductive material). In this case, active pin 136A is operable to establish an electrosurgical connection between sheath 172 of medical instrument 170 and an ancillary device, such as an electrosurgical generator (not shown) operable to generate radio frequency, or RF, current.

[0026] The body 132A of the end cap 130A may include one or more components configured to engage with corresponding components on the cap cover 120A to couple the end cap 130A to the cap cover 120A. For example, in this example, the end cap 130A includes one or more protrusions 138A extending outward from one or more sidewalls of the central body 132A and positioned relatively adjacent to a distal portion of the body 132A. The number of protrusions 138A included in the body 132A of the end cap 130A corresponds to the number of holes 128A included in the body 122A of the cap cover 120A. In this example, the end cap 130A includes a pair of protrusions 138A corresponding to a pair of holes 128A on the cap cover 120A. In this case, each of the pair of protrusions 138A is sized and shaped to correspond to the size and shape of the pair of holes 128A such that the pair of holes 128A each receive the pair of protrusions 138A therein to couple the cap cover 120A to the end cap 130A. Alternatively, the protrusions 138A may include a variety of suitable shapes, sizes, and / or configurations other than those shown and described herein. Furthermore, additional and / or fewer protrusions 138A may be included on the body 132A of the end cap 130A without departing from the scope of the present invention.

[0027] 2 , end cap 130A includes one or more ridges 139A disposed along the proximal end of body 132A. One or more ridges 139A are disposed between and defined by one or more recesses 137A disposed along the proximal end of body 132A. In this example, end cap 130A includes recesses 137A formed between adjacent pairs of ridges 139A. As described further herein, ridges 139A of end cap 130A are sized and shaped to correspond to one or more components of rotating assembly 150A (e.g., distal flange 154A) to facilitate alignment and / or engagement of rotating assembly 150A with the proximal end of end cap 130A. End cap 130A further includes engagement interface 140A disposed along the proximal end of body 132A. As described in more detail herein, engagement interface 140A includes one or more components configured to engage corresponding components of rotating assembly 150A to couple end cap 130A to rotating assembly 150A.

[0028] The rotating assembly 150A includes a body 152A defined by a distal flange 154A and a proximal end 151A. In this example, the body 152A of the rotating assembly 150A includes one or more features disposed along the exterior of the rotating assembly 150A to facilitate manual manipulation of the rotating assembly 150A. By way of example only, the body 152A of the rotating assembly 150A may include one or more protrusions, recesses, flanges, tabs, and similar surface features to allow a user of the medical system 100 to easily grip the body 152A. The body 152A is further sized and shaped to be received in the distal opening 124A and the proximal opening 126A of the cap cover 120A when the rotating assembly 150A is inserted therein. The distal flange 154A of the rotating assembly 150A has a size at least larger than the proximal opening 126A to prevent the rotating assembly 150A from being removed from the cap cover 120A through the proximal opening 126A during use of the medical system 100.

[0029] 2, the distal flange 154A extends radially outward from the body 152A and extends around the outer periphery of the body 152A. In some examples, the distal flange 154A includes one or more flat edges and / or one or more curved edges. In the example shown and described herein, the distal flange 154A includes a pair of curved edges and a pair of flat edges disposed therebetween. The pair of curved edges of the distal flange 154A are sized and shaped to correspond to the size and shape of the ridges 139A of the end cap 130A. Thus, the distal flange 154A is received by or between the pair of ridges 139A of the end cap 130A in response to moving the distal end of the rotating assembly 150A toward the proximal end of the end cap 130A. In some examples, one or more ridges 139A of end cap 130A are operable to snap onto or mate with distal flange 154A of rotating assembly 150A.

[0030] The slot 127A on the body 122A of the cap cover 120A and the recess 137A on the body 132A of the end cap 130A are sized, shaped, and configured to receive the curved edge of the distal flange 154A when the rotating assembly 150A is received between and rotated relative to the cap cover 120A and the end cap 130A. In other words, the slot 127A and the recess 137A are operable to accommodate the curved edge of the distal flange 154A when the rotating assembly 150A is rotated such that the curved edge 154A is aligned with the slot 127A and the recess 137A, respectively.

[0031] 2, the rotating assembly 150A further includes a distal shaft 156A extending outward from the distal flange 154A. The distal shaft 156A extends distally from the body 152A and away from the proximal end 151A. The distal shaft 156A may include one or more ridges 158A disposed along the longitudinal length of the distal shaft 156A. In this example, the distal shaft 156A includes a plurality of ridges 158A extending radially outward from the outer surface of the distal shaft 156A. The plurality of ridges 158A of the distal shaft 156A are defined by at least one recess formed between a pair of adjacent ridges 158A. As described in further detail herein, ridges 158A on distal shaft 156A engage one or more components (e.g., flex arms 142A) of engagement interface 140A on end cap 130A to couple rotating assembly 150A to end cap 130A and provide tactile feedback during use (e.g., rotation of rotating assembly 150A). Proximal end 151A of rotating assembly 150A includes proximal opening 153A that facilitates access to the lumen of rotating assembly 150A. The lumen of rotating assembly 150A extends through body 152A from proximal opening 153A to a distal opening located at the distal-most portion of distal shaft 156A (see FIG. 3 ). As described above, the lumen of rotating assembly 150A is sized, shaped, and configured to receive one or more instruments and / or devices therethrough, such as, for example, needle 179 of medical instrument 170.

[0032] 3 , the distal shaft 156A of the rotation assembly 150A passes through the proximal end of the end cap 130A and is received within the body 132A of the end cap 130A. The engagement interface 140A of the end cap 130A includes one or more flex arms 142A extending radially inward from an inner circumferential surface into the lumen of the end cap 130A. The one or more flex arms 142A are circumferentially adjacent to one another and are offset relative to adjacent flex arms 142A. In some examples, the one or more flex arms 142A extend along an axis that is offset from the longitudinal axis of the engagement interface 140A (e.g., does not intersect with the radial center of the lumen of the engagement interface 140A). In other words, the one or more flex arms 142A do not extend toward the radial center of the engagement interface 140A.

[0033] In this example, engagement interface 140A includes four flex arms 142A, although in other examples, engagement interface 140A may include additional and / or fewer flex arms 142A. Flex arms 142A engage one or more ridges 158A on distal shaft 156A of rotating assembly 150A when rotating assembly 150A is received within end cap 130A. In some examples, flex arms 142A may include an abutment element, such as a protrusion, a rounded / circular tip, a curved surface, or the like, at a distal end of flex arm 142A that engages with one or more ridges 158A on distal shaft 158A. Thus, flex arms 142A are operable to at least partially couple rotating assembly 150A to end cap 130A in response to engaging one or more ridges 158A on distal shaft 156A. Flex arms 142A of end cap 130A extend into the lumen of body 132A in an angled array and are flexibly deformable to deform in response to an applied radial force.

[0034] According to an exemplary method of using the cap cover 120A, end cap 130A, and rotation assembly 150A with the medical system 100 during a procedure, the medical system 100 is initially inserted into a patient's body and manipulated to position the medical instrument 170 received in the handle 110 adjacent to a target treatment site. At least the cannula 176 of the medical instrument 170 is secured to the rotation assembly 150A such that rotation of the rotation assembly 150A relative to the cap cover 120A, end cap 130, and / or handle 110 rotates the cannula 176 within the lumens of the outer body 112 and inner body 114. Thus, the rotation assembly 150A can control the radial orientation of the cannula tip 178. In examples where the tip 178 includes a predetermined shape and / or configuration, such as a J-shaped tip 178 as shown in FIG. 1C , rotation of the rotation assembly 150A controls the position and / or orientation of the J-shaped tip 178. Thus, a user can actuate the rotation assembly 150A at the proximal end of the medical system 100 to rotate the cannula 176 and the tip 178 of the cannula 176 near the target treatment site. If a needle 179 is received within the cannula 176, actuation of the rotation assembly 150A can cause the needle 179 to rotate simultaneously with the cannula 176. In some examples, the needle 179 can be removed from the lumen of the cannula 176, and actuation of the rotation assembly 150A can rotate the cannula 176 and / or other devices / instruments disposed within the cannula 176.

[0035] When the distal shaft 156A of the rotating assembly 150A extends through the lumen of the end cap 130A and rotates therein, the flex arms 142A of the end cap 130A flex outward. The ridges 158A on the distal shaft 156A abut the flex arms 142A, thereby exerting a radially outward force on the flex arms 142A. In this case, the ridges 158A cause each of the flex arms 142A to bend at least partially away from the distal shaft 156A until it aligns with a recess formed between a pair of adjacent ridges 158A. Receiving a portion of the flex arms 142A within the recess on the distal shaft 156A can at least partially fix the radial orientation of the rotating assembly 150A relative to the cap cover 120A, the end cap 130A, and the handle 110. When received within a recess on distal shaft 156A, flex arm 142A can partially prevent further rotation of rotating assembly 150A (eg, until a user again rotates rotating assembly 150A).

[0036] In this example, the rotating assembly 150A generates indexing feedback in response to rotating the rotating assembly 150A relative to the cap cover 120A, the end cap 130A, and / or the handle 110. For example, a user of the medical system 100 experiences tactile, audible, and / or visual feedback on the body 152A of the rotating assembly 150A when the flex arm 142A of the end cap 130A is received within a recess between an adjacent pair of ridges 158A or when rotating the rotating assembly 150A. In this case, the user of the medical system 100 can incrementally index the position (e.g., orientation) of the medical instrument 170, e.g., the cannula 176 and (if disposed within the cannula 176) the needle 179, relative to the handle 110 by receiving the indexing feedback.

[0037] Recesses formed between adjacent ridges 158A along the distal shaft 156A form a plurality of predefined angular intervals at which the rotating assembly 150A (and medical instrument 170) can be positioned. Therefore, the amount of recesses and / or ridges 158A included along the distal shaft 156A can determine the amount of predefined angular interval formed by the rotating assembly 150A. Furthermore, the ridges 158A on the distal shaft 156A prevent movement of the rotating assembly 150A at each of the plurality of predefined angular intervals by engaging the flex arms 142A with pairs of adjacent ridges 158A. The flex arms 142A can apply a force to maintain the rotating assembly 150A in at least one of the predefined angular intervals. Overcoming this force allows movement of the rotating assembly 150A and the cannula 176 relative to the handle 110 by applying a rotational force to the body 152A greater than the force applied by the flex arms 142A.

[0038] Referring now to FIG. 4 , an example of an end cap 130B and a rotating assembly 150B is shown and described herein. The end cap 130B and rotating assembly 150B of this example may be integrated with the cap cover 120A shown and described above. Except as otherwise expressly stated herein, the end cap 130B and rotating assembly 150B are configured and operatively similar to the end cap 130A and rotating assembly 150A, respectively, described above, and corresponding numerals are used to identify similar features. For example, the rotating assembly 150B includes a body 152B defined by a proximal end 151B and a distal flange 154B, the proximal end 151B including a proximal opening 153B that facilitates access to the lumen of the rotating assembly 150B.

[0039] Body 152B of rotating assembly 150B may include one or more luer elements, for example, at and / or adjacent to proximal opening 153B, as shown in FIG. 4 . In this case, luer elements of rotating assembly 150B are configured to allow attachment of a medical device (e.g., a syringe) to proximal opening 153B of rotating assembly 150B, facilitating communication between the lumen of rotating assembly 150B and the medical device. Rotating assembly 150B further includes distal shaft 156B extending distally from distal flange 154B and defining at least a distal portion of the lumen of rotating assembly 150B. Rotating assembly 150B differs from rotating assembly 150A described above in that distal flange 154B is defined by a single, continuous curved edge extending around the outer periphery of body 152B.

[0040] End cap 130B may include a body 132B with one or more alignment elements 138B disposed along the exterior surface of body 132B. In this example, end cap 130B includes a pair of alignment elements 138B, although end cap 130B may include additional and / or fewer alignment elements 138B without departing from the scope of the present invention. The pair of alignment elements 138B engage with corresponding elements of one or more other components of medical device 100 to facilitate alignment and / or engagement of end cap 130B to components of medical device 100, such as, for example, a rotation assembly cover (not shown) that seals rotation assembly 150A therein, cap cover 120A, etc. For example, the rotation assembly cover may be a component of needle 179, and alignment element 138B may interface with the rotation assembly cover as a rotation stop.

[0041] 4, the end cap 130B may further include a ridge 137B and one or more locks 139B extending around the proximal end of the body 132B. In this example, the end cap 130B includes a pair of locks 139B, each of which is disposed circumferentially adjacent to the ridge 137B at the proximal end of the body 132B. The ridges 137B are sized and shaped to correspond to the contour of the distal flange 154B of the rotating assembly 150B so as to receive the distal flange 154B therein. The pair of locks 139B are flexibly movable relative to the ridges 137B and engage with the distal flange 154B in response to the distal flange 154B being received against the ridges 137B, thereby connecting the end cap 130B to the rotating assembly 150B. In some examples, the pair of locks 139B include protrusions extending radially inward relative to the ridges 137B, and the protrusions of the locks 139B are operable to abut against the distal flange 154B to secure the rotating assembly 150B to the end cap 130B.

[0042] End cap 130B further includes an engagement interface 140B at the proximal end of body 132B having one or more flex arms 142B extending inwardly into the lumen of end cap 130B. In this example, flex arms 142B of engagement interface 140B are generally similar to flex arms 142A of engagement interface 140A on end cap 130A shown and described above. Distal shaft 156B of rotating assembly 150B includes one or more ridges 158B and corresponding recesses formed between pairs of adjacent ridges 158B. In this example, ridges 158B and distal shaft 156B of rotating assembly 150B are generally similar to ridges 158A and distal shaft 156A of rotating assembly 150A shown and described above. Rotating assembly 150B is therefore configured to interact with end cap 130B in a manner similar to that described above with respect to rotating assembly 150A and end cap 120A.

[0043] Referring now to FIG. 5, examples of cap cover 120C, end cap 130C, and rotating assembly 150C are shown and described herein. Except as expressly stated otherwise herein, cap cover 120C, end cap 130C, and rotating assembly 150C are configured and operatively similar to cap cover 120A, end cap 130A, and rotating assembly 150A, respectively, and corresponding numerals are used to identify similar features. For example, rotating assembly 150C includes a body 152C defined by a proximal end 151C and a distal flange 154C, where proximal end 151C includes a proximal opening 153C ( FIG. 6 ) that facilitates access to the lumen of rotating assembly 150C. Additionally, rotating assembly 150C includes a distal shaft 156C extending distally from distal flange 154C. Rotating assembly 150C differs from rotating assembly 150A described above in that distal shaft 156C includes one or more holes 158C formed therein. Distal shaft 156C of rotating assembly 150C includes a plurality of holes / recesses 158C extending in an annular array around the exterior of distal shaft 156C. The plurality of holes / recesses 158C may be spaced apart from one another at any suitable interval along distal shaft 156C of rotating assembly 150C.

[0044] The cap cover 120C includes a body 122C defined by a distal opening 124C and a proximal opening 126C. The distal opening 124C is sized, shaped, and configured to receive the rotation assembly 150C and the cap cover 120C therethrough. The body 122C further includes a recess 128C sized and shaped to receive one or more components of the end cap 130C, such as, for example, a pin housing 134C, therethrough. The body 122C of the cap cover 120C further includes one or more openings 129C through the outer surface of the body 122C and within the lumen of the body 122C. As described further below, the cap cover 120C includes a pair of openings 129C, each of which receives a fastener (not shown) therethrough to couple the cap cover 120C to another component of the medical system 100, such as, for example, the end cap 130C (FIG. 6).

[0045] 5, the end cap 130C includes a body 132C having an outwardly extending pin housing 134C and one or more engagement tabs 137C extending distally from a distal portion of the body 132C. In this example, the end cap 130C includes a pair of engagement tabs 137C extending distally from the distal portion of the body 132C, the engagement tabs 137C being disposed around a lumen of the body 132C. The pair of engagement tabs 137C align and engage the end cap 130C with the handle 110 of the medical system 100. For example, the pair of engagement tabs 137C are operable to engage with the outer body 112 of the handle 110, thereby coupling the end cap 130C to the outer body 112.

[0046] The end cap 130C may further include one or more openings 138C, 139C formed through the exterior surface of the body 132C to extend into the lumen of the body 132C. The end cap 130C includes a pair of distal openings 138C and a pair of proximal openings 139C, with the distal openings 138C disposed adjacent a distal portion of the body 132C relative to the proximal openings 139C and the proximal openings 139C disposed adjacent a proximal end of the body 132C relative to the distal openings 138C. As described further below, each of the pair of distal openings 138C receives a fastener (not shown) therethrough that couples the end cap 130C to another component of the medical system 100, such as the cap cover 120C (FIG. 6). In this example, end cap 130C further includes detent 140C, which is sized, shaped, and configured to be received within at least one of proximal openings 139C. As described in further detail herein, detent 140C engages with at least one of a plurality of recesses 158C disposed along distal shaft 156C of rotating assembly 150C in response to end cap 130C receiving rotating assembly 150C therethrough. In some examples, detent 140C may include a ball and / or protrusion element coupled to a distal portion of a spring and / or biasing mechanism. In this case, the ball / protrusion on the distal portion of the spring may be a portion of detent 140C received within recess 158C. In other examples, detent 140C may include a longitudinally expandable and compressible resilient protrusion.

[0047] 6, detent 140C is shown within proximal opening 139C and engaged with one of a plurality of recesses 158C. In this case, detent 140C, when at least partially received within recess 158C, maintains rotating assembly 150C at a fixed radial position (e.g., orientation) relative to cap cover 120C, end cap 130C, and / or handle 110. Distal flange 154C of rotating assembly 150C is disposed between and engaged by the proximal end of cap cover 120C and the proximal end of end cap 130C. Distal flange 154C is received within cavity 133C formed between the proximal end of cap cover 120C and the proximal end of end cap 130C. In this case, rotating assembly 150C is axially and longitudinally fixed relative to cap cover 120C and end cap 130C. In other examples, the end cap 130C may include additional detents 140C, such as, for example, in another proximal opening 139C in the body 132C. As described above, with the cap cover 120C positioned over the end cap 130C, a pair of openings 129C on the body 122C of the cap cover 120C may align with a pair of distal openings 138C on the body 132C of the end cap 130C. In this case, fasteners (not shown) can be received in the corresponding openings 129C, 138C to fasten the cap cover 120C to the end cap 130C.

[0048] According to an exemplary method of using the cap cover 120C, end cap 130C, and rotating assembly 150C in the medical system 100 during a procedure, the detent 140C can engage the distal shaft 156C when the rotating assembly 150C is received through a lumen in the end cap 130C. The detent 140C is biased toward the distal shaft 156C and received in at least one of the recesses 158C. As the distal shaft 156C rotates within the end cap 130C, the rotating assembly 150C moves (e.g., pushes) the detent 140C out of the recess 158C (compressing the spring of the detent 140C). Rotation of the rotating assembly 150C causes the detent 140C to exit the recess 158C and be received along the outer surface (i.e., space) of the distal shaft 156C disposed between a pair of adjacent recesses 158C.

[0049] In this example, the outer surface of the distal shaft 156C may abut the detent 140C and exert a radially outward force (compressing the spring) against the detent 140C. In this case, the rotating assembly 150C may move the ball / protrusion of the detent 140C out of the recess 158C until the ball / detent is aligned with at least another recess 158C along the distal shaft 156C. Reception of the detent 140C within the recess 158C on the distal shaft 156C may at least partially fix the radial orientation of the rotating assembly 150C relative to the cap cover 120C, the end cap 130C, and the handle 110. When the detent 140C is biased toward and received within at least one recess 158C on the distal shaft 156C, the recess 158C and the detent 140C may collectively prevent further rotation of the rotating assembly 150C.

[0050] In this example, the rotating assembly 150C generates indexing feedback in response to rotating the rotating assembly 150C relative to the cap cover 120C, the end cap 130C, and / or the handle 110. For example, a user of the medical system 100 may experience tactile and / or audible feedback on the body 152C of the rotating assembly 150C when the detents 140C of the end cap 130C are received within at least one of the holes 158C on the distal shaft 156C and / or during rotation of the rotating assembly 150C. In this case, a user of the medical system 100 may incrementally index the radial position (e.g., orientation) of the medical instrument 170, e.g., the cannula 176 and needle 179 (when disposed within the cannula 176), relative to the handle 110 by receiving the indexing feedback.

[0051] A plurality of recesses 158C included along the distal shaft 156C may form a plurality of predefined angular intervals at which the rotating assembly 150C (and medical instrument 170) may be aligned. Additionally, the plurality of recesses 158C on the distal shaft 156C may prevent movement of the rotating assembly 150C at each of the plurality of predefined angular intervals by engaging a detent 140C in at least one of the plurality of recesses 158C. The detent 140C may exert a force to maintain the rotating assembly 150C in at least one of the predefined angular intervals. This force may be overcome to allow movement of the rotating assembly 150C and cannula 176 relative to the handle 110 by applying a predetermined rotational force to the body 152C that is greater than the force exerted by the spring in the detent 140C.

[0052] 7-9, examples of a cap cover 120D, an end cap 130D, and a rotation assembly 150D are shown and described herein. Except as expressly stated otherwise herein, the cap cover 120D, the end cap 130D, and the rotation assembly 150D are configured and operatively similar to the cap cover 120A, the end cap 130A, and the rotation assembly 150A, respectively, and corresponding numerals are used to identify similar features. For example, with reference to FIG. 7, the end cap 130D includes a body 132D defining a lumen 139D extending between a proximal end and a distal end of the body 132D. The proximal end of the body 132D includes an engagement interface 140D having a proximal-facing annulus 142D extending radially inward into the lumen 139D of the body 132D. The rings 142D of the engagement interface 140D extend into the lumen 139D to such an extent that the rings 142D at least partially define the size (eg, diameter) and shape of the lumen 139D.

[0053] The engagement interface 140D may further include two or more proximally-facing holes / recesses 144D formed on the annulus 142D. In this example, the engagement interface 140D includes a plurality of holes / recesses 144D disposed along the annulus 142D and facing the proximal end of the end cap 130D. The plurality of holes / recesses 144D are circumferentially spaced apart from one another along the engagement interface 140D such that adjacent holes / recesses 144D are offset from one another at various suitable intervals. As described further herein, each of the plurality of holes / recesses 144D is sized and shaped to correspond to the size and shape of one or more components of the rotating assembly 150D, such as, for example, the protrusion 158D. In some examples, one or more of the plurality of holes / recesses 144D may include different sizes and / or shapes relative to one another that correspond to the size and / or shape (e.g., spherical, cubic, and / or other complementary shapes) of the protrusion 158D. Alternatively, the ring 142D on the end cap 130D may include additional and / or fewer holes / recesses 144D than those shown and described herein without departing from the scope of the present invention.

[0054] 7, end cap 130D may further include one or more alignment elements 138D disposed along the outer surface of body 132D. In this example, end cap 130D includes a pair of alignment elements 138D, however, end cap 130D may include additional and / or fewer alignment elements 138D without departing from the scope of the present invention. The pair of alignment elements 138D engage with corresponding elements of one or more components of medical device 100 to facilitate alignment and / or engagement of end cap 130D to the corresponding component, such as, for example, a rotation assembly cover (not shown), cap cover 120D, etc. For example, the rotation assembly cover may be a component of needle 179, and alignment element 138D may interface with the rotation assembly cover as a rotation stop.

[0055] Referring now to FIG. 8, rotating assembly 150D includes a body 152D defined by a proximal end 151D and a distal flange 154D, where the proximal end 151D includes a proximal opening 153D (see FIG. 9) that facilitates access to the lumen of the rotating assembly 150D. Additionally, rotating assembly 150D includes a distal shaft 156D extending distally from the distal flange 154D. Rotating assembly 150D differs from rotating assembly 150A described above in that the distal flange 154D includes one or more distally-facing protrusions 158D formed on the distal flange 154D. The distal flange 154D of rotating assembly 150D includes a pair of protrusions 158D extending outward from the outer surface of the distal flange 154D opposite the body 152D. In other examples, the rotating assembly 150D may include additional and / or fewer protrusions 158D along various other suitable surfaces than those shown and described herein. In examples where the rotating assembly 150D includes multiple protrusions 158D, the protrusions 158D may be circumferentially spaced apart from one another by a distance corresponding to the area between adjacent holes / recesses 144D along the annulus 142D of the engagement interface 142D.

[0056] 9 , as noted above, the protrusion 158D has a size, shape, and configuration to be received within one or more holes / recesses 144D along the annulus 142D of the engagement interface 140D when the rotating assembly 150D is received within the end cap 130D. In this case, the protrusion 158D, when received within at least one of the holes / recesses 144D on the annulus 142D, at least partially maintains the rotating assembly 150D in a fixed radial position (e.g., orientation) relative to the cap cover 120D, the end cap 130D, and / or the handle 110. The distal flange 154D is received along the annulus 142D of the engagement interface 140D and engages the annulus 142D when the protrusion 158D is received within the hole / recess 144D formed on the annulus 142D.

[0057] Distal flange 154D is maintained against ring 142D of end cap 130D by one or more gaskets 157D disposed between the outer surface of distal flange 154D opposite ring 142D and the inner surface of cap cover 120D. In this example, one or more gaskets 157D include O-rings formed from an elastomer that contact or press distal flange 154D of rotating assembly 150D against ring 142D of end cap 130D when cap cover 120D is coupled to end cap 130D. In other words, attachment of cap cover 120D with end cap 130D can generate a force that both limits movement of one or more gaskets 157D (e.g., O-rings) and elastically deforms one or more gaskets 157D to allow linear movement of rotating assembly 150D.

[0058] 9 , although the cap cover 120D in this example includes a single gasket 157D, additional gaskets 157D may be included between the cap cover 120D and the distal flange 154D beyond those shown and described herein. For example, in other examples, the gasket 157D may be omitted entirely from between the cap cover 120D and the rotating assembly 150D, or may include various deformable or spring-like devices other than the O-rings described herein. Furthermore, as described in more detail below, the gasket 157D flexibly deforms in response to, for example, a compressive force applied to the distal flange 154D and / or the cap cover 120D, allowing the protrusion 158D to disengage from the hole / recess 144D.

[0059] According to an exemplary method of using the cap cover 120D, end cap 130D, and rotating assembly 150D with the medical system 100 during a procedure, the medical system 100 is first inserted into a patient's body and manipulated so that the medical instrument 170 received within the handle 110 is positioned adjacent to a target treatment site. With the distal shaft 156D of the rotating assembly 150D extending through the lumen of the end cap 130D, each of the protrusions 158D of the rotating assembly 150D can engage with or be received within at least one of the holes / recesses 144D on the end cap 130D. The protrusions 158D are biased outward from the distal flange 154D and are received within at least one of the holes / recesses 144D on the annulus 142D. As the distal shaft 156D rotates within the end cap 130D, the rotating assembly 150D moves (e.g., rotates) the protrusions 158D out of the holes / recesses 144D.

[0060] Rotation of the rotating assembly 150D may cause the protrusions 158D to exit the holes / recesses 144D and be received along the outer surface of the ring 142D between a pair of adjacent holes / recesses 144D. In this case, the outer surface of the ring 142D may abut the protrusions 158D, thereby exerting a force acting in a proximal direction on the distal flange 154D of the rotating assembly 150D. In this case, the rotating assembly 150D may move proximally relative to the cap cover 120D and the end cap 130D such that the distal flange 154D abuts against the gasket 157D disposed between the cap cover 120D and the distal flange 154D. As a result, the distal flange 154D may compress the gasket 157D (high energy state) when the pair of protrusions 158D are not received in at least one hole / recess 144D on the ring 142D until it is aligned with at least another hole / recess 144D (low energy state). Compression of the gasket 157D places the rotating assembly 150D in a high energy state compared to a low energy state in which the pair of projections 158D are received within the at least one hole / recess 144D and the gasket 157D is not compressed.

[0061] Receiving at least a portion of the pair of protrusions 158D within the holes / recesses 144D of the engagement interface 140D can at least partially fix the radial orientation of the rotating assembly 150D relative to the cap cover 120D, the end cap 130D, and the handle 110. When the protrusions 158D are biased toward and received within the at least one hole / recess 144D on the annulus 142D, the holes / recesses 144D and the protrusions 158D can collectively prevent further rotation of the rotating assembly 150D. In this instance, the gasket 157D can expand, thereby placing the rotating assembly 150D in a low-energy state.

[0062] In this example, the rotating assembly 150D generates indexing feedback in response to rotating the rotating assembly 150D relative to the cap cover 120D, the end cap 130D, and / or the handle 110. For example, a user of the medical system 100 may experience tactile and / or audible feedback on the body 152D of the rotating assembly 150D when the protrusion 158D on the distal flange 154D is received within at least one of the holes / recesses 144D on the annulus 142D of the end cap 130D and / or during rotation of the rotating assembly 150D. In this case, a user of the medical system 100 may incrementally index the radial position (e.g., orientation) of the medical instrument 170, e.g., the cannula 176 and needle 179 (if disposed within the cannula 176), relative to the handle 110 by receiving the indexing feedback.

[0063] A plurality of holes / recesses 144D included along the annulus 142D of the engagement interface 140D form a plurality of predefined angular intervals at which the rotating assembly 150D (and medical instrument 170) may be positioned. Additionally, a plurality of holes / recesses 144D on the end cap 130D inhibits movement of the rotating assembly 150D at each of the plurality of predefined angular intervals by engaging a protrusion 158D in at least one of the plurality of holes / recesses 144D. The holes / recesses 144D and / or protrusions 158D may collectively apply a force that maintains the rotating assembly 150D at at least one of the predefined angular intervals. Applying a rotational force to the body 152D greater than the force imparted by the holes / recesses 144D and / or protrusions 158D, as generated by compression of the gasket 157D, may overcome this force and allow movement of the rotating assembly 150D and cannula 176 relative to the handle 110.

[0064] 10 and 11 , an example of a rotating assembly 150E is shown and described herein. The rotating assembly 150E of this example may be integrated with the cap cover 120D and end cap 130D shown and described above. Furthermore, except as expressly stated otherwise herein, the rotating assembly 150E is configured and operative similarly to the rotating assembly 150A described above, and corresponding numerals are used to identify similar features. For example, the rotating assembly 150E includes a body 152E defined by a proximal end 151E and a distal flange 154E, the proximal end 151E including a proximal opening 153E (see FIG. 10 ) that facilitates access to the lumen of the rotating assembly 150E. Furthermore, the rotating assembly 150E includes a distal shaft 156E extending distally from the distal flange 154E.

[0065] The rotating assembly 150E differs from the rotating assembly 150A described above in that the distal flange 154E includes one or more detents 158E formed thereon or otherwise attached thereto. The distal flange 154E of the rotating assembly 150E includes detents 158E extending outward from an outer surface of the distal flange 154E opposite the body 152E. In other examples, the rotating assembly 150E may include additional detents 158E along various suitable surfaces other than those shown and described herein. Furthermore, in other examples, the one or more detents 158E may be formed on one or more other components of the medical device 100 other than the rotating assembly 150E. The detents 158E of the rotating assembly 150E are biased in an extended state against the outer surface of the distal flange 154E, as shown in FIG. 10 .

[0066] Detent 158E of rotating assembly 150E is flexibly deformable and deforms (e.g., compressed) from an extended state to a retracted state, for example, when a predetermined force is applied. In some examples, detent 158E may include a ball and / or protrusion element coupled to a distal portion of a spring and / or biasing mechanism. In this case, the ball / protrusion on the distal portion of the spring may be the portion of detent 158E received within hole / recess 144D. In other examples, detent 158E may include a resilient protrusion that is longitudinally expandable and compressible. In other examples, detent 158E may be a screw threaded into distal flange 154E and configured to transition from the extended state to the retracted state by rotating it outwardly and / or inwardly, respectively, relative to distal flange 154E.

[0067] 11 , as described above, the detent 158E is sized, shaped, and configured to be received within one or more holes / recesses 144D along the annulus 142D of the engagement interface 142D when the rotating assembly 150E is received within the end cap 130D. In this case, the detent 158E at least partially maintains the rotating assembly 150E in a fixed position (e.g., orientation) relative to the cap cover 120D, the end cap 130D, and / or the handle 110 when received within at least one of the holes / recesses 144D on the annulus 142D. The distal flange 154E of the rotating assembly 150E is received along the annulus 142D of the engagement interface 140D and engages the ridge 142D when the detent 158E is received within at least one of the holes / recesses 144D formed on the annulus 142D.

[0068] According to an exemplary method of using the cap cover 120D, end cap 130D, and rotating assembly 150E with the medical system 100 during a procedure, the detent 158E can engage and / or be received within at least one of the holes / recesses 144D when the distal shaft 156E of the rotating assembly 150E extends through the lumen of the end cap 130D. The detent 158E is biased distally and outwardly from the distal flange 154E and is at least partially received within at least one of the holes / recesses 144D on the annulus 142D. In this case, the hole / recess 144D has a size and shape such that the detent 158E can be only partially disposed within the hole / recess 144D. Thus, the distal flange 154E is biased from the annulus 142D when the detent 158E is in the extended state, thereby forming a space and / or gap between the distal flange 154E and the ridge 142D. The rotating assembly 150E moves the detent 158E out of the hole / recess 144D (compressing the spring in the detent 158E) as the distal shaft 156E rotates within the end cap 130D.

[0069] Rotation of the rotating assembly 150E causes the detent 158E to exit the hole / recess 144D and be received along the outer surface of the annulus 142D between a pair of adjacent holes / recesses 144D. In this case, the detent 158E abuts the outer surface of the annulus 142D, thereby applying a longitudinal proximal force (compressing the spring) against the detent 158E of the rotating assembly 150E. In this case, the space / gap between the distal flange 154E and the annulus 142D provides a clearance through which the detent 158E can be compressed to transition from an extended state to a retracted state. It should be appreciated that movement of the rotating assembly 150E relative to the cap cover 120D and the end cap 130D is minimized due to the compression of the detent 158E. Thus, when the detent 158E is in the retracted state, the distal flange 154E is biased away from the annulus 142D of the engagement interface 140D at least until aligned with another hole / recess 144D. Reception of at least a portion of the detent 158E within the at least one hole 144D of the engagement interface 140D may at least partially secure the radial orientation of the rotating assembly 150E relative to the cap cover 120D, the end cap 130D, and the handle 110. When the detent 158E is biased toward and received within the at least one hole / recess 144D on the annulus 142D, the hole 144D and the detent 158E may collectively prevent further rotation of the rotating assembly 150E.

[0070] In this example, the rotating assembly 150E generates indexing feedback in response to rotating the rotating assembly 150E relative to the cap cover 120D, the end cap 130D, and / or the handle 110. For example, a user of the medical system 100 may experience tactile and / or audible feedback on the body 152E of the rotating assembly 150E when the detents 158E on the distal flange 154E are received within at least one of the holes / recesses 144D on the annulus 142D of the end cap 130D and / or during rotation of the rotating assembly 150E. In this case, a user of the medical system 100 may incrementally index the radial position (e.g., orientation) of the medical instrument 170, e.g., the cannula 176 and needle 179, relative to the handle 110 by receiving the indexing feedback.

[0071] A plurality of holes / recesses 144D included along the annulus 142D of the engagement interface 140D form a plurality of predefined angular intervals at which the rotating assembly 150E (and medical instrument 170) can be positioned. Additionally, a plurality of holes / recesses 144D on the end cap 130D inhibit movement of the rotating assembly 150E at each of the plurality of predefined angular intervals by engaging a detent 158E in at least one of the plurality of holes / recesses 144D. The holes / recesses 144D and / or detent 158E can exert a collective force to maintain the rotating assembly 150E at at least one of the predefined angular intervals. This force can be overcome to allow movement of the rotating assembly 150E and cannula 176 relative to the handle 110 by applying a rotational force to the body 152E greater than the force exerted by the holes / recesses 144D and / or detent 158E.

[0072] 12, an example of a cap cover 120F, an end cap 130F, and a rotating assembly 150F are shown and described herein. Except as otherwise expressly stated herein, the cap cover 120F, the end cap 130F, and the rotating assembly 150F are configured and operatively similar to the cap cover 120A, the end cap 130A, and the rotating assembly 150A, respectively, and corresponding numerals are used to identify similar features. For example, the rotating assembly 150F includes a body 152F defined by a proximal end 151F and a distal flange 154F, the proximal end 151F including a proximal opening 153F (FIGS. 13 and 14) that facilitates access to the lumen of the rotating assembly 150F. Additionally, the rotating assembly 150F includes a distal shaft 156F extending distally from the distal flange 154F.

[0073] The rotating assembly 150F differs from the rotating assembly 150A described above in that the distal flange 154F includes one or more deflectable and / or flexible arms 158F formed thereon. The distal flange 154F of the rotating assembly 150F includes a pair of flexible arms 158F extending outward from the periphery of the distal flange 154F. In this example, each of the pair of flexible arms 158F is sized, shaped, and configured to be received within one or more components of the end cap 130F, such as the openings 144F. As described in further detail herein, each of the pair of flexible arms 158F engages with one or more components of the end cap 130F when the end cap 130F receives the rotating assembly 150F. For example, the flexible arms 158F are operable to engage with a pair of protrusions 142F of the end cap 130F in response to insertion of the rotating assembly 150F into the end cap 130F.

[0074] 12 , the cap cover 120F can include a body 122F defined by a distal opening 124F and a proximal opening 126F. The distal opening 124F is sized, shaped, and configured to receive the rotating assembly 150F and the cap cover 120F therein. The body 122F further includes a side window 125F and one or more holes 128F along a sidewall of the cap cover 120F. The side window 125F is sized and shaped to receive one or more components of the end cap 130F, such as, for example, a pin housing 134F, therethrough. The end cap 130F can include a body 132F having a pin housing 134F extending outwardly therefrom and one or more engagement tabs 137F extending radially outward from the body 132F. The one or more engagement tabs 137F are sized, shaped, and configured to engage with the proximal end of the outer body 112, thereby coupling the end cap 130F to the handle 110. Additionally or alternatively, the one or more engagement tabs 137F may be configured to engage with one or more holes 128F formed along the sidewall of the cap cover 120F, thereby coupling the end cap 130F to the cap cover 120F.

[0075] The end cap 130F may further include an engagement interface 140F along a proximal end of the end cap 130F. As described above, the engagement interface 140F of the end cap 130F includes one or more proximally-facing protrusions 142F and one or more proximally-facing recesses 144F formed thereon. The protrusions 142F alternate with and define the recesses 144F. The engagement interface 140F includes a plurality of protrusions 142F and a plurality of recesses 144F formed along the proximal end of the body 132F, with at least one recess 144F disposed between adjacent pairs of the protrusions 142F. As described in further detail herein, each of the plurality of recesses 144F has a size, shape, and configuration to receive at least one flexible arm 158F of the rotation assembly 150F between an adjacent pair of the protrusions 142F when the end cap 130F is coupled to the rotation assembly 150F.

[0076] As shown in FIG. 13 , the rotating assembly 150F includes at least one slot 159F disposed between the distal flange 154F and each of the flexible arms 158F. The flexible arms 158F of the rotating assembly 150F extend outward from the distal flange 154F relative to the size, shape, and configuration of the at least one slot 159F. As described further herein, each of the flexible arms 158F is movable relative to the distal flange 154F in response to expansion and / or compression of the slot 159F disposed therebetween. Thus, the flexible arms 158F and / or the slot 159F are deformable relative to the distal flange 154F, and movement of the flexible arms 158F can increase or decrease the size of the slot 159F.

[0077] 14 , the rotating assembly 150F is shown within the end cap 130F, with the flexible arm 158F received within at least one of the recesses 144F. In this case, the flexible arm 158F, when received within the recess 144F, at least partially maintains the rotating assembly 150F in a fixed radial position (e.g., orientation) relative to the cap cover 120F, the end cap 130F, and / or the handle 110. The distal flange 154F of the rotating assembly 150F is disposed between and engaged by the proximal end of the cap cover 120F and the proximal end of the end cap 130F. In this case, the rotating assembly 150F is longitudinally and axially fixed relative to the cap cover 120F and the end cap 130F. In other examples, the rotating assembly 150F may include additional and / or fewer flexible arms 158F on the distal flange 154F.

[0078] According to an exemplary method of using the cap cover 120F, end cap 130F, and rotation assembly 150F in the medical system 100 during a procedure, the flexible arms 158F of the distal flange 154F can engage with the recesses 144F along the engagement interface 140F when the distal shaft 156F of the rotation assembly 150F is received within the lumen of the end cap 130F. The flexible arms 158F are biased outward from the distal flange 154F and received within at least one of the recesses 144F. In this case, the flexible arms 158F are maintained in an extended state, with each of the flexible arms 158F disposed within at least one recess 144F. The rotation assembly 150F moves the flexible arms 158F out of the recesses 144F as the distal shaft 156F rotates within the end cap 130F.

[0079] Rotation of the rotating assembly 150F can cause the flexible arms 158F to move radially inward and out of the recesses 144F and align with at least one protrusion 142F of the engagement interface 140F. In this case, the flexible arms 158F can abut against the protrusions 142F, thereby exerting a radially inward force on the flexible arms 158F. In this case, the end cap 130F transitions the flexible arms 158F from an extended state to a compressed state until they are aligned with at least another recess 144F between a pair of protrusions 142F. In the compressed state, at least one slot 159F disposed between the distal flange 154F and each of the flexible arms 158F deforms as the flexible arms 158F move radially inward toward the distal flange 154F.

[0080] At least a portion of each of the flexible arms 158F may be received within the at least one recess 144F to at least partially fix radial rotation of the rotating assembly 150F relative to the cap cover 120F, the end cap 130F, and the handle 110. When the flexible arms 158F are biased toward and received within the at least one recess 144F on the end cap 130F, the protrusions 142F, the recesses 144F, and the flexible arms 158F may collectively prevent further rotation of the rotating assembly 150F.

[0081] In this example, the rotating assembly 150F generates indexing feedback in response to rotating the rotating assembly 150F relative to the cap cover 120F, the end cap 130F, and / or the handle 110. For example, a user of the medical system 100 may experience tactile and / or audible feedback on the body 152F of the rotating assembly 150F when the flexible arm 158F on the distal flange 154F is received within one of the recesses 144F on the end cap 130F and / or during rotation of the rotating assembly 150F. In this case, a user of the medical system 100 may incrementally index the radial position (e.g., orientation) of the medical instrument 170, e.g., the cannula 176 and (if disposed within the cannula 176) the needle 179, relative to the handle 110 by receiving the indexing feedback.

[0082] A plurality of recesses 144F included along the engagement interface 140F form a plurality of predefined angular intervals at which the rotating assembly 150F (and medical instrument 170) may be positioned. Furthermore, the plurality of recesses 144F are sized, shaped, and configured to prevent movement of the rotating assembly 150F at each of the plurality of predefined angular intervals by engaging the flexible arms 158F between a pair of adjacent protrusions 142F. The protrusions 142F, recesses 144F, and / or flexible arms 158F may collectively apply a force to maintain the rotating assembly 150F at at least one of the predefined angular intervals. This force may be overcome to allow movement of the rotating assembly 150F and cannula 176 relative to the handle 110 by applying a rotational force to the body 152F greater than the force applied by the protrusions 142F, recesses 144F, and / or flexible arms 158F.

[0083] Each of the above devices, assemblies, and methods can be used to facilitate access to a target treatment site and enhance control of auxiliary instruments / devices used at the target treatment site. By providing a medical device with a rotational assembly that can control multiple instruments / devices of a medical device coupled to the medical device at predefined angular intervals, a user can interact with the target treatment site using various instruments / devices of the medical device during a procedure and receive feedback on the position of the instruments / devices. In this instance, the user can reduce overall procedure time, improve the efficiency of the procedure, and avoid unnecessary damage to the patient's body that may result from limited control of auxiliary instruments / devices.

[0084] It will be apparent to those skilled in the art that various modifications and variations can be made in the disclosed apparatus and methods without departing from the scope of the invention. Other aspects of the invention will be apparent to those skilled in the art from consideration of the specification and practice of the features disclosed herein. It is intended that the specification and examples be considered as illustrative only.

Claims

1. Sheath and an instrument disposed within the sheath and capable of longitudinal and rotational movement relative to the sheath; a handle including a rotation assembly configured to rotate the instrument relative to the sheath in response to rotation of the rotation assembly relative to a portion of the handle; the rotation assembly rotates the instrument relative to the sheath through a plurality of predefined angular intervals and prevents rotational movement of the instrument relative to the sheath at each angular interval; the rotating assembly including a shaft having a plurality of circumferentially alternating ridges and recesses; the handle includes a plurality of arms extending radially inward into a lumen of the handle, each arm of the plurality of arms configured to engage with the plurality of ridges and the plurality of recesses; when a first arm of the plurality of arms is disposed within a first recess of the plurality of recesses, rotational movement between the rotation assembly and the portion of the handle is prevented; A medical device, wherein each arm of the plurality of arms extends along an axis that does not intersect with a radial center of the lumen of the handle.

2. The medical device of claim 1 , wherein the rotation assembly maintains the instrument at at least one of the predefined angular intervals to secure the instrument relative to the sheath.

3. The medical device of claim 2 , wherein the rotating assembly releases the instrument from at least one of the predefined angular intervals in response to a predetermined rotational force applied to the rotating assembly.

4. 4. The medical device of claim 1, wherein the rotating assembly generates at least one of tactile, audible, or visual feedback as it rotates through the predefined angular intervals.

5. 2. The medical device of claim 1, wherein while the first arm is positioned within the first recess, a rotational force is applied to the rotating assembly relative to the portion of the handle, causing the first arm to move out of the first recess and position the first arm within a second recess circumferentially adjacent to the first recess.

6. The medical device of claim 1, wherein the rotating assembly further comprises a lumen extending therethrough.

7. The medical device of claim 1, wherein the handle further includes one or more alignment elements disposed on an outer surface.

8. The medical device of claim 1, wherein the handle includes a lock configured to engage with the rotating assembly to secure the rotating assembly to the handle.

9. The medical device of claim 1, further comprising a cap cover, the cap cover including a proximal opening and a distal opening, the proximal opening and the distal opening each configured to receive a portion of the rotating assembly.

10. The medical device of claim 9, wherein the cap cover includes one or more holes configured to receive one or more protrusions on the handle.

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