Medical device rotation assembly and method of use thereof

Abstract

The medical device includes a cannula, a tool inside the cannula and movable relative to the cannula, and a handle including a rotation assembly; the rotation assembly is configured to rotate the tool relative to the cannula as the rotation assembly rotates relative to a portion of the handle. The rotation assembly rotates the tool relative to the cannula at predetermined angular gaps and prevents movement at each predetermined angular gap.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to U.S. Provisional Patent Application No. 62 / 969,881, filed on February 4, 2020, the entire contents of which are incorporated herein by reference. Technical Field

[0003] Various aspects of the present disclosure generally relate to medical systems, medical devices, and related methods. Among other aspects, at least some examples of the present disclosure relate to systems, devices, and related methods for indicating and controlling the position of one or more medical devices within a patient during surgery. Background Art

[0004] Technological developments have provided users of medical systems, medical devices, and methods with the ability to perform increasingly complex surgeries on subjects. One problem in the field of minimally invasive surgery (e.g., endoscopy, laparoscopy, and thoracoscopy, as well as other surgical procedures) is related to providing control over the orientation and position of medical devices during surgery. The placement of such medical devices inside a patient can be difficult. In addition, maintaining the desired position of the device is unreliable. Restrictions on medical devices that facilitate the entry of other devices into a patient for placement can prolong surgery, limit its effectiveness, and / or cause damage to the patient due to device failure or breakage. Summary of the invention

[0005] Additionally, aspects of the present disclosure relate to systems, devices, and methods for accessing a target treatment site with a medical device having features that facilitate device positioning.Each aspect disclosed herein may include one or more features described in conjunction with any other disclosed aspect.

[0006] According to one example, a medical device includes a cannula, a tool movable relative to the cannula within the cannula, and a handle including a rotation assembly configured to rotate the tool relative to the cannula as a portion of the rotation assembly relative to the handle rotates. The rotation assembly rotates the tool relative to the cannula at predetermined angular gaps and prevents movement at each predetermined angular gap.

[0007] Any medical device described herein may have any of the following features. The rotating assembly holds the tool with at least one predetermined angular gap to fix the tool relative to the sleeve. As a predetermined rotational force is applied to the rotating assembly, the rotating assembly releases the tool from at least one of the predetermined angular gaps. When the rotating assembly rotates between the predetermined angular gaps, the rotating assembly generates at least one of tactile, auditory or visual feedback. The rotating assembly includes a shaft having a plurality of ridges, which alternate circumferentially with a plurality of grooves. The handle includes one or more arms. Each arm of the one or more arms is configured to engage with a plurality of ridges and a plurality of grooves. When the first arm of the one or more arms is located in the first groove of the plurality of grooves, the rotating assembly prevents rotational movement between the rotating assembly and a portion of the handle. When the first arm is located in the first groove, a rotational force is applied to the rotating assembly relative to a portion of the handle, causing the first arm to leave the first groove and causing the first arm to be located in a second groove circumferentially adjacent to the first groove. The one or more arms include a plurality of arms extending radially inward into the inner cavity of the handle. Each arm of the plurality of arms is offset relative to each arm of the other plurality of arms. The rotating assembly includes a plurality of grooves or apertures arranged in the outer surface of the rotating assembly. The handle includes one or more stops configured to engage with the plurality of grooves or apertures. When the first stop of the one or more stops is located in the first groove or aperture of the plurality of grooves or apertures, the rotating assembly prevents the rotational movement between the rotating assembly and a portion of the handle. The first stop includes a compressible portion. When the first stop is located in the first groove or aperture, a rotational force is applied to the rotating assembly relative to a portion of the handle causing the first stop to compress and leave the first groove, and causing the first stop to be located in a second groove or aperture circumferentially adjacent to the first groove or aperture. The rotating assembly includes a distally facing flange, wherein a protrusion extends distally from the distally facing flange. The handle includes a proximal facing flange having a plurality of circumferentially spaced grooves or apertures. The protrusion is configured to be received by each groove or aperture of the plurality of grooves or apertures, so that when the protrusion is received by one groove or aperture in the plurality of grooves or apertures, the rotational movement between the rotating member and a portion of the handle is prevented. The medical device also includes a deformable member arranged on the proximal side of the distal-facing flange. The deformable member causes the distal-facing flange to be offset toward the proximal-facing flange. When the protrusion is located in the first groove or aperture, applying a rotational force to the rotational assembly relative to a portion of the handle causes the deformable member to be compressed, causing the protrusion to leave the first groove or aperture, and causing the protrusion to be located in a second groove or aperture circumferentially adjacent to the first groove or aperture. The protrusion includes a compressible portion. When the protrusion is located in the first groove or aperture, applying a rotational force to the rotational assembly relative to a portion of the handle causes the protrusion to be compressed and leave the first groove or aperture, and causes the protrusion to be located in a second groove or aperture circumferentially adjacent to the first groove or aperture.The handle includes a plurality of protrusions and a plurality of grooves. The plurality of protrusions and the plurality of grooves alternate with each other. The rotational assembly includes a compressible member. The compressible member is configured to be received by each groove of the plurality of grooves, so that when the protrusion is received by one of the plurality of grooves, the rotational movement between the rotational assembly and a portion of the handle is prevented. The rotational assembly includes a flange having a groove enclosed by the flange. The compressible member includes a periphery of the flange that defines at least a portion of the groove. When the compressible member is located in the first groove, applying a rotational force to the rotational assembly relative to a portion of the handle causes the compressible member to be radially compressed inwardly while reducing the volume of the groove, causing the compressible member to leave the first groove, and causing the compressible member to be located in a second groove circumferentially adjacent to the first groove or orifice.

[0008] According to another example, a medical device includes a handle including a rotational assembly movable relative to a remainder of the handle, a cannula extending from the handle, and a tool movable relative to the cannula within the cannula. As the rotational assembly rotates relative to at least a portion of the handle, the rotational assembly rotates the tool relative to the cannula to a plurality of predetermined angular positions. When the rotational assembly rotates from one of the plurality of predetermined angular positions to another of the plurality of predetermined angular positions, the rotational assembly provides at least one of tactile feedback or audible feedback to a user.

[0009] Any medical device described herein may have any of the following features. The rotating assembly holds the tool in at least one of the predetermined angular positions to fix the tool relative to the sleeve. As a predetermined rotational force is applied to the rotating assembly, the rotating assembly releases the tool from at least one of the predetermined angular positions. When the rotating assembly rotates between the predetermined angular positions, the rotating assembly generates at least one of tactile, auditory or visual feedback. The rotating assembly includes a shaft having a plurality of ridges that alternate circumferentially with a plurality of grooves. The handle includes one or more arms. Each arm of the one or more arms is configured to engage with a plurality of ridges and a plurality of grooves. When a first arm of the one or more arms is located in a first groove of a plurality of grooves, the rotating assembly prevents rotational motion between the rotating assembly and a portion of the handle.

[0010] According to another example, a method of rotating a tool relative to a cannula to a plurality of predetermined angular positions includes rotating the assembly relative to a handle to a second predetermined angular position away from a first predetermined angular position. The method includes generating a first indexing feedback at the rotating assembly as the rotating assembly rotates out of the first predetermined angular gap, and generating a second indexing feedback at the rotating assembly as the rotating assembly is rotated into the second predetermined angular position. The first predetermined angular position is for maintaining the tool in a first fixed orientation relative to the cannula, and the second predetermined angular position is for maintaining the tool in a second fixed orientation relative to the cannula.

[0011] It is to be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the invention, as claimed. BRIEF DESCRIPTION OF THE DRAWINGS

[0012] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate exemplary aspects of the present disclosure and, together with the description, serve to explain the principles of the present disclosure.

[0013] Figure 1A is a side view of an exemplary medical system including a medical device and a medical instrument according to aspects of the present disclosure, wherein the medical device has a rotating assembly;

[0014] Figure 1B is a cross-sectional side view of the medical device of FIG. 1 , wherein the medical device includes a needle in an extended state, according to aspects of the present disclosure;

[0015] Figure 1C is a cross-sectional side view of the medical device of FIG. 1 according to aspects of the present disclosure, wherein the medical device includes a cannula in an extended state;

[0016] Figure 2 is an exploded view of the rotating assembly of FIG. 1 according to aspects of the present disclosure;

[0017] Figure 3 is a bottom view of the rotating assembly of FIG. 1 according to aspects of the present disclosure;

[0018] Figure 4 is an exploded view of another exemplary rotational assembly of the medical device of FIG. 1 according to aspects of the present disclosure;

[0019] Figure 5 is an exploded view of another exemplary rotational assembly of the medical device of FIG. 1 according to aspects of the present disclosure;

[0020] Figure 6 According to various aspects of this disclosure Figure 5 A cross-sectional view of a rotating assembly;

[0021] Figure 7 is a perspective view of another exemplary rotational assembly of the medical device of FIG. 1 according to aspects of the present disclosure;

[0022] Figure 8 According to various aspects of this disclosure Figure 7 A side view of a rotating assembly;

[0023] Fig. 9 According to various aspects of this disclosure Figure 8 A cross-sectional view of a rotating assembly;

[0024] Fig.10 is a side view of another exemplary rotational assembly of the medical device of FIG. 1 according to aspects of the present disclosure;

[0025] Fig.11 According to various aspects of this disclosure Fig.10 A cross-sectional view of a rotating assembly;

[0026] Fig.12 is an exploded side view of another rotational assembly of the medical device of FIG. 1 according to aspects of the present disclosure;

[0027] Fig.13 According to various aspects of this disclosure Fig.12 a bottom view of the rotating assembly of the device; and

[0028] Fig.14 According to various aspects of this disclosure Fig.12 A cross-sectional view of a rotating assembly. DETAILED DESCRIPTION

[0029] In addition, examples of the present disclosure include systems, devices and methods for indicating the position and / or orientation of multiple components of a medical device at a target site inside the body. Reference will now be made in detail to various aspects of the present disclosure, and examples of the present disclosure are described in the accompanying drawings. Whenever possible, the same or similar reference numerals will be used to refer to the same or similar components in the various drawings. The term "distal" refers to the part farthest from the user when the device is introduced into the patient. In contrast, the term "proximal" refers to the part closest to the user when the device is placed into the patient. The words "comprise", "comprising" or any other variants thereof used herein are intended to cover non-exclusive inclusion, so that a process, method, article, or apparatus including a series of elements may not necessarily include only these elements, but may include other elements that are not explicitly listed or that are unique to such a process, method, article, or apparatus. The word "exemplary" is used in the sense of "exemplary" rather than "ideal". The words "about", "roughly", and "approximately" used herein represent a series of values ​​within + / -10% of the stated value.

[0030] The various examples of the present disclosure can be used to facilitate the control of the position and orientation of the tool / device of the medical device at the target treatment site by providing one or more mechanisms and / or components for indicating the movement of the tool / device. For example, some examples incorporate a rotating assembly into the medical device for selectively controlling and / or manipulating the various components of the medical device received inside the medical device to a plurality of predetermined angular gaps / positions. The rotating assembly can be configured to control the radial orientation of the distal end of the medical device. The medical device may include a body (which defines an inner cavity configured to receive the medical device therein) and a rotating assembly (which is connected to the medical device for moving the medical device inside the inner cavity of the body). The medical device may include a sleeve and a tool (e.g., an approach sleeve) arranged inside the sleeve. The rotating assembly may be located outside the body and connected to the tool of the medical device inside the inner cavity, so that the position and orientation of the tool relative to the body can be indicated as the rotating assembly is actuated. The rotating assembly of the medical device can also provide selective control and / or manipulation of the various components of the medical device to a plurality of predetermined angular gaps / positions.

[0031] Examples of the present disclosure may relate to devices and methods for performing various medical procedures and / or treating the large intestine (colon), small intestine, cecum, esophagus, portions of the gastrointestinal tract, any other portion, and / or any other suitable patient anatomical structure (collectively referred to herein as "target treatment site"). The devices and related methods may be used laparoscope or endoscope, or used in any other open or minimally invasive surgery (including thoracic and ear, nose and throat surgery). Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Whenever possible, the same reference numerals will be used to refer to the same or similar parts throughout the drawings.

[0032] Figure 1A A schematic diagram of an exemplary medical system 100 according to one example of the present disclosure is shown. The medical system 100 may include a handle 110 and a medical device 170. In this example, the handle 110 includes an outer body 112 and an inner body 114, wherein the outer body 112 has a longitudinal length and defines an inner cavity that is sized, shaped, and configured to receive the inner body 114. As described in more detail herein, the outer body 112 is configured to move relative to the inner body 114, and vice versa, the inner body 114 is configured to move relative to the outer body 112. The inner body 114 of the handle 110 has a longitudinal length and defines an inner cavity that is sized, shaped, and configured to receive the medical device 170.

[0033] In this example, the inner body 114 includes a rack having a plurality of teeth 116 extending along the exterior of the inner body 114. The plurality of teeth 116 extend along at least a portion of the longitudinal length of the inner body 114 (up to the entire longitudinal length), which portion corresponds to the range of motion of the outer body 112 relative to the inner body 114. Therefore, it should be understood that the rack having the plurality of teeth 116 may extend along various other suitable lengths and / or surfaces of the inner body 114 other than those illustrated and described herein without departing from the scope of the present disclosure. The handle 110 may also include a cover 120, an end cap 130, and a rotation assembly 150 (which is disposed on and / or coupled to the outer body 112). The cover 120 of the handle 110 may be located at the proximal end of the outer body 112 and, when fastened to the outer body 112, is configured to enclose the inner cavity of the outer body 112 between the cover 120 and the outer body 112. The end cap 130 and the rotation assembly 150 extend from and / or are coupled to the cover 120. As described in more detail herein, the cover 120, the end cap 130, and the rotation assembly 150 of the handle 110 can have various suitable configurations and / or arrangements relative to each other and relative to the handle 110.

[0034] In addition, 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 may be disposed within the lumen of the sheath 172, and the needle 179 may be disposed within the lumen of the cannula 176 and may extend 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 a 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 a 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 handle 110 may be configured and operable (movably) to position medical device 170 relative to a target treatment site within a patient (e.g., a patient anatomy). For example, when needle 179 extends distally from tip 174, medical device 170 may be operable to pierce the target treatment site with needle 179, such as Figure 1B as shown in .

[0035] Still refer to Figure 1AIn some examples, the medical device 17 can be operable to facilitate access to a target treatment site with the cannula 176 (including and / or in addition to the needle 179) for one or more tools and / or devices. In this case, when the needle 179 is removed from the lumen of the cannula 176, one or more additional tools and / or devices can be received through the lumen of the cannula 176 and extend outwardly and distally therefrom through the tip 178 of the cannula 176. In some examples, the cannula 176 can be configured and operable to deform as (in response to) the needle 179 being at least partially retracted from the tip 178 of the cannula 176. Additionally and / or alternatively, in other instances, the sleeve 176 may be configured and operable to deform as the top end 178 of the sleeve 176 extends outwardly and distally from the top end 174 of the sheath 172, or conversely, the top end 174 of the sheath 172 extends proximally relative to the top end 178 of the sleeve 178.

[0036] like Figure 1C As shown in , when the needle 179 is omitted and / or the tip 178 extends from the lumen of the sheath 172, the tip 178 of the cannula 176 can be configured and operable to conform to a predetermined shape and / or configuration (e.g., a J-shape). It should be understood that the retraction of the needle 179 from the cannula 178 and / or the extension of 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 shape and / or configuration, such as Figure 1A-1B As described in greater detail herein, the rotation assembly of the handle 110 may be configured and operable (active) to control the positioning of the J-shaped tip 178 of the cannula 176 during a procedure.

[0037] In addition, in some instances, the medical device 170 can be operable to electrosurgically dilate the target treatment site with the sheath 172. In this case, the sheath 172 includes an electrosurgical cannula and the tip 174 includes an electrosurgical tip. It should be understood that in other instances, the medical device 170 may include various other suitable tools, structures, hypotubes, and / or components different from those illustrated and described herein. By way of illustrative example, in some instances, the medical device 170 may include an electrosurgical tip (e.g., a cystotomy needle) with the tip 178 omitted, such as for delivering a stent during surgery. In other instances, the medical device 170 omits components for electrical activation.

[0038] Refer again Figure 1A, the handle 110 may further include a first actuator 118 and a second actuator 119 located on the outer body 112. In this example, the first actuator 118 and the second actuator 119 are arranged above the outer body 112. The first actuator 118 is fastened and / or coupled to the outer body 112 and is configured to move the outer body 112 relative to the inner body 114 as the first actuator 118 is actuated. In this example, the first actuator 118 is integral with the outer body 112, so that the first actuator 118 and the outer body 112 form an integrated structure. In addition, the second actuator 119 is fastened and / or coupled to the inner body 114 and is configured to move the inner body 114 relative to the outer body 112 as the second actuator 119 is actuated. For example, the second actuator 119 can be coupled to the inner body 114 through the outer body 112, for example, 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 can be constructed and operated according to at least part of the teachings of U.S. Patent Application [Customer Reference No. 19-0411PV01, Attorney Docket No. 06530-1057-00600], filed on the same date, entitled “Medical Device Locking Assemblies and Methods of Using the Same,” the disclosure of which is incorporated herein by reference.

[0039] The handle 110 also includes a distal housing 160 located at the distal end of the inner body 114 opposite the outer body 112. The distal housing 160 of the handle 110 defines an inner cavity, the size, shape, and configuration of which are designed 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 may also include a housing top 162 and a screw (fastener) 164. In this example, the housing top 162 includes an opening, the size and shape of which are designed to facilitate the medical device 170 to leave the inner cavity of the distal housing 160 and / or the inner body 114. The screw 164 is configured to engage with the outer surface of the inner body 114 within the inner cavity of the distal housing 160 to securely couple the inner body 114 to the distal housing 160. In this case, the screw 164 can be moved (e.g., rotated) relative to the distal housing 160 to selectively engage and / or disengage with the inner body 114 received therein. It should be understood that various other suitable fastening elements, clamps, pins, etc. are also conceivable without departing from the scope of the present disclosure.

[0040] The following description provides various examples of the cover 120, end cap 130, and rotating assembly 150 illustrated and described above. Each exemplary cover 120, end cap 130, and / or rotating assembly 150 mentioned herein can be applied to the handle 110 and medical device 170 described above, and can be applied to the various surgeries described herein. Therefore, it should be understood that any cover 120, end cap 130, and / or rotating assembly 150 illustrated and described herein (see Figure 2-Figure 12 ) can be easily incorporated into the above detailed description and in Figure 1A The medical system 100 shown in FIG.

[0041] Now refer to Figure 2 , an example of cover 120A, end cap 130A, and rotating assembly 150A is illustrated and described herein. In this example, cover 120A includes a main body 122A defined by a distal opening 124A and a proximal opening 126A. As further described herein, the size, shape, and configuration of the distal opening 124A of the main body 122A are designed to at least partially pass through and receive end cap 130A and / or rotating assembly 150A. In addition, the size, shape, and configuration of the proximal opening 126A of the main body 122A are designed to pass through and receive rotating assembly 150A. The main body 122A of cover 120A also includes a groove 125A formed between the distal opening 124A and the proximal opening 126A along the sidewall of the main body 122A. As further described herein, the size and shape of the groove 125A are designed to receive one or more components of the end cap 130A when the cover 120A is coupled to one or more components of the end cap 130A (e.g., the pin housing 134A). The cover 120A may include one or more grooves 127A formed along one or more side walls of the body 122A. The one or more grooves 127A may extend along an axis that is orthogonal (e.g., substantially perpendicular) to the longitudinal axis of the handle 110. The cover 120A includes a pair of grooves 127A, which are formed through a pair of side walls of the body 122A and are relatively located adjacent to the proximal opening 126A.

[0042] In addition, cover 120A may include one or more orifices 128A formed along one or more side walls of body 122A. Cover 120A includes a pair of orifices 128A, which are formed through a pair of side walls of body 122A and are relatively located adjacent to distal opening 124A. In this example, a pair of grooves 127A and a pair of orifices 128A of cover 120A are formed along the same side walls of body 122A, but it should be understood that, without departing from the scope of the present disclosure, grooves 127A and / or orifices 128A can be positioned along various other walls / or surfaces of body 122A of cover 120A. For example, the same side walls of body 122A may include grooves 127A and orifices 128A. It should also be understood that in other examples, cover 120A may include more and / or less grooves 127A and orifices 128A than disclosed and described herein.

[0043] Still refer to Figure 2 , the end cap 130A includes a center body 132A and a pin housing 134A extending radially outward from the center body 132A. The pin housing 134A may be orthogonal (e.g., substantially perpendicular) to the longitudinal axis of the center body 132A of the end cap 130A. As described above, when the end cap 130A is coupled to the cover 120A, the pin housing 134A extends outward from the body 122A of the end cap 130A through the groove 125A. The pin housing 134A of the end cap 130A includes an active pin 136A disposed therein, so that the pin housing 134A encloses the active pin (connector) 136A. In this example, when the end cap 130A is coupled to the outer body 112 and the medical device 170 is disposed inside the inner body 120, the active pin 36A can be operably established in communication with the medical device 170. For example, the active pin 136A can be communicatively connected to one or more components of the medical device 170, such as a sheath 172 (e.g., an electrosurgical cannula comprising a conductive material). In this case, the active pin 136A can be operable to establish an electrosurgical connection between the sheath 172 of the medical device 170 and an auxiliary device (e.g., an electrosurgical generator (not shown) operable to generate a high frequency current or radio frequency current).

[0044] The body 132A of the end cap 130A may include one or more components that are configured and operably engaged with corresponding components of the cover 120A to couple the end cap 130A to the cover 120A. For example, in this example, the end cap 130A may include one or more protrusions 138A that extend outwardly from one or more side walls of the center body 132A and are located at a position close to the distal end of the body 132A. It should be understood that the number of protrusions 138A included on the body 132A of the end cap 130A corresponds to the number of orifices 128A included on the body 122A of the cover 120A. In this example, the end cap 130A includes a pair of protrusions 138A corresponding to a pair of orifices 128A on the cover 120A. In this case, the size and shape of each protrusion of a pair of protrusions 138A can be designed to correspond to the size and shape of the orifice 128A, so that the pair of orifices 128A are configured to receive a pair of protrusions 138A therein, respectively, to couple the cover 120A to the end cap 130A. In other examples, the protrusions 138A may include various other suitable shapes, sizes, and / or configurations different from those illustrated and described herein. In addition, more 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 disclosure.

[0045] Still refer to Figure 2 , the end cap 130A may include one or more protrusions 139A arranged along the proximal end of the body 132A. The one or more protrusions 139A may be arranged between and defined by one or more grooves 137A arranged along the proximal end of the body 132A. In this example, the end cap 130A includes a groove 137A formed and defined between an adjacent pair of protrusions 139A. As further described herein, the size and shape of the protrusion 139A of the end cap 130A are designed in accordance with one or more components (e.g., distal flange 154A) of the rotational assembly 150A, thereby facilitating the alignment and / or engagement of the rotational assembly 150A with the proximal end of the end cap 130A. The end cap 130A also includes a mating interface 140A positioned along the proximal end of the body 132A. As described in greater detail herein, the mating interface 140A may include one or more components that are configured and operably engage corresponding components of the rotational assembly 150A to couple the end cap 130A to the rotational assembly 150A.

[0046] The rotational assembly 150A may include a body 152A defined by a distal flange 154A and a proximal end 151A. In this example, the body 152A of the rotational assembly 150A may include one or more features (convex and concave structures) arranged along the exterior of the rotational assembly 150A, thereby facilitating manual manipulation of the rotational assembly 150A. By way of example only, the body 152A of the rotational assembly 150A may include one or more protrusions, grooves, flanges, tabs, and similar surface features for providing ease of gripping the body 152A by a user of the medical system 100. The size and shape of the body 152A are also designed to be received through the distal opening 124A and the proximal opening 126A of the cover 120A when the rotational assembly 150A is inserted into the cover 120A. It should be appreciated that the distal flange 154A of the rotational assembly 150A is sized to be relatively larger than at least the proximal opening 126A to prevent removal of the rotational assembly 150A from the cover 120A through the proximal opening 126A during use of the medical system 100 .

[0047] Still refer to Figure 2 , the distal flange 154A extends radially outward from the body 152A, for example, the distal flange 154A extends around the periphery of the body 152A. In some examples, the distal flange 154A may include one or more straight edges and / or one or more curved edges. In the examples illustrated and described herein, the distal flange 154A includes a pair of straight edges each disposed between a pair of curved edges. The size and shape of the pair of curved edges of the distal flange 154A are designed in accordance with the size and shape of the protrusion 139A of the end cap 130A. Therefore, it should be understood that the distal flange 154A is configured to be received by a pair of protrusions 139A of the end cap 130A and / or received between these protrusions 139A as the distal end of the rotational assembly 150A is moved toward the proximal end of the end cap 130A. In some examples, one or more protrusions 139A of end cap 130A can operably snap onto and / or interlock with distal protrusion 154A of rotation assembly 150A to couple rotation assembly 150A to end cap 130A.

[0048] It should be understood that the size, shape, and configuration of the slot 127A on the body 122A of the cover 120A and the groove 137A on the body 132A of the end cap 130A are designed to receive the curved edge of the distal flange 154A when the rotational assembly 150A is received between the cover 120A and the end cap 130A and rotated relative to the cover 120A and the end cap 130A. In other words, the slot 127A and the groove 137A are operable to receive the curved edge of the distal flange 154A when the rotational assembly 150A is rotated so that the curved edge 154A is aligned with the slot 127A and the groove 137A, respectively.

[0049] Still refer to Figure 2 , the rotation assembly 150A also includes a distal shaft 156A extending outwardly from the distal flange 154A. The distal shaft 156A extends distally from the distal flange 154A in a manner away from the body 152A and the proximal end 151A. The distal shaft 156A may include one or more ridges 158A arranged along the longitudinal length of the distal shaft 156A. In this example, the distal shaft 156A includes a plurality of ridges 158A extending radially outwardly from the outside of the distal shaft 156A. The plurality of ridges 158A of the distal shaft 156A may be defined by at least one groove formed between a pair of adjacent ridges 158A. As described in more detail herein, the ridge 158A on the distal shaft 156A is configured to engage with one or more components of the mating interface 140A on the end cap 130A (e.g., the flexure arm (flexure arm) 142A) to couple the rotation assembly 150A to the end cap 130A and provide tactile feedback during use (e.g., rotation of the rotation assembly 150A). The proximal end 151A of the rotation assembly 150A includes a proximal opening 153A that facilitates access to the lumen of the rotation assembly 150A. It should be understood that the lumen of the rotation assembly 150A can extend from the proximal opening 153A through the body 152A to the distal opening located at the farthest end of the distal shaft 156A (see Figure 3 As described above, the lumen of the rotation assembly 150A is sized, shaped, and configured to receive one or more tools and / or devices (eg, needle 179 of medical device 170) therethrough.

[0050] Now refer to Figure 3 , the distal shaft 156A of the rotation assembly 150A can be received in the body 132A of the end cap 130A through the proximal end of the end cap 130A. The mating interface 140A of the end cap 130A may include one or more bending arms 142A that extend radially inward from the circumferential inner surface into the inner cavity of the end cap 130. The one or more bending arms 142A may be circumferentially adjacent to each other and deflected relative to adjacent bending arms 142A. In some examples, one or more bending arms 142A extend along an axis that is deflected relative to the longitudinal axis of the mating interface 140 (e.g., does not intersect the radial center of the inner cavity of the mating interface 140A). In other words, one or more bending arms 142A do not extend toward the radial center of the mating interface 140A.

[0051] In this example, the mating interface 140A includes four flexure arms 142A, however, it should be understood that in other examples, the mating interface 140A may include more and / or fewer flexure arms 142A. The flexure arms 142A are configured to engage with one or more ridges 158A on the distal shaft 156 of the rotation assembly 150A when the rotation assembly 150A is received inside the end cap 130A. In some examples, the flexure arms 142A may include an engagement feature at the distal end of the flexure arms 142A, which is configured and operable (movably) to engage with one or more ridges 158A (e.g., a protrusion, a rounded / annular tip, a curved surface, etc.) of the distal shaft 158A. Therefore, in response to (in response to) engaging with one or more ridges 158A on the distal shaft 156A, the flexure arms 142A may operably at least partially couple the rotation assembly 150A to the end cap 130A. It will be appreciated that the flexure arms 142A of the end cap 130A extend into the interior cavity of the body 132A in an angular array and are flexibly deformable such that the flexure arms 142A are configured to deform in response to receiving a radial force applied thereto.

[0052] According to an exemplary method of using the cover 120A, the end cap 130A, and the rotation assembly 150 with the medical system 100 during surgery, the medical system 100 can first be inserted into a patient and manipulated so that the medical device 170 received within the handle 110 is located near the target treatment site. At least the sleeve 176 of the medical device 170 is fastened to the rotation assembly 150A so that rotation of the rotation assembly 150A relative to the cover 120A, the end cap 130, and / or the handle 110 provides rotation of the sleeve 176 within the lumen of the outer body 112 and the inner body 114. Therefore, the rotation assembly 150A can control the radial orientation of the tip 178 of the sleeve. In the embodiment of the present invention, the tip 178 includes a predetermined shape and / or configuration (e.g., a J-shaped tip 178 (e.g., Figure 1C In the example shown in ), rotation of the rotation assembly 150A provides position and / or directional control 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. Because the needle 179 is received within the cannula 176, it should be understood that actuation of the rotation assembly 150A can provide synchronous rotation of the needle 179 and the cannula 176. In some examples, the needle 179 can be removed from the lumen of the cannula 176 so that actuation of the rotation assembly 150A can provide rotation of the cannula 176 and / or other devices / instruments disposed within the cannula 176.

[0053] Since the distal shaft 156A of the rotational assembly 150A extends through the lumen of the end cap 130A, the flexure arms 142A of the end cap 130A may bend outwardly when the distal shaft 156A of the rotational assembly 150A rotates therein. The ridges 158A on the distal shaft 156A may abut against the flexure arms 142A, thereby exerting an outward radial force on the flexure arms 142A. In this case, the ridges 158A may cause each flexure arm 142A to bend at least partially away from the distal shaft 156A until it becomes aligned with a groove formed between a pair of adjacent ridges 158A. Receiving a portion of the flexure arm 142A in the groove on the distal shaft 156A may at least partially fix the radial orientation of the rotational assembly 150A relative to the cover 120A, the end cap 130, and the handle 110. It should be appreciated that when received within the recess of the distal shaft 156A, the flexure arm 142A can partially prevent further rotation of the rotation assembly 150A (eg, until the user again rotates the rotation assembly 150A).

[0054] In this example, the rotational assembly 150A is configured to generate indexing feedback (positioning feedback) as the rotational assembly 150A rotates relative to the cover 120A, the end cap 130A, and / or the handle 110. For example, when the curved arm 142A of the end cap 130A is received in the groove between the adjacent pair of ridges 158A and / or when the rotational assembly 150A is rotated, the user of the medical system 100 can feel tactile, auditory, and / or visual feedback at the body 152A of the rotational assembly 150A. In this case, the user of the medical system 100 can progressively indicate (index, guide, index) the position (e.g., orientation) of the medical device 170 (e.g., cannula 176 and needle 179) (when disposed inside the cannula 176) relative to the handle 110 by receiving the indexing feedback.

[0055] It should be understood that the grooves formed along the distal shaft 156A between adjacent ridges 158A form a plurality of predetermined angular intervals at which the rotation assembly 150A (and the medical device 170) can be positioned. Therefore, the number of grooves and / or ridges 158A included along the distal shaft 156A can determine the number of predetermined angular intervals formed by the rotation assembly 150A. In addition, the ridges 58A on the distal shaft 156A are configured to prevent the movement of the rotation assembly 150A at each of the plurality of predetermined angular intervals by aligning the curved arms 142A with an adjacent pair of ridges 158A. The curved arms 142A can provide a force for maintaining the rotation assembly 150A in at least one of the predetermined angular intervals. This force can be overcome by applying a rotational force greater than the force applied by the curved arms 142A to the body 152A, thereby allowing the rotation assembly 150A and the sleeve 176 to move relative to the handle 110.

[0056] Now refer to Figure 4 , an example of an end cap 130B and a rotating assembly 150B is illustrated and described herein. It should be understood that the end cap 130B and the rotating assembly 150B of this example can be combined with the cover 120A illustrated and described above. It should also be understood that, unless otherwise explicitly stated herein, the end cap 130B and the rotating assembly 150B can be respectively configured to be similar to the end cap 130A and the rotating assembly 150A described above and operate, and thus similar features are marked with corresponding numbers. For example, the rotating assembly 150B may include a body 152B defined by a proximal end 151B and a distal flange 154B, wherein the proximal end 151B includes a proximal opening 153B, which facilitates access to the inner cavity of the rotating assembly 150B.

[0057] It should be appreciated that the body 152B of the rotational assembly 150B may include one or more Luer features, such as Figure 4 , located at and / or adjacent to the proximal opening 153B. In this case, the Luer feature of the rotational assembly 150B can be configured to allow a medical device (e.g., a syringe) to be attached to the proximal opening 153B of the rotational assembly 150B, thereby facilitating fluid communication between the inner cavity of the rotational assembly 150B and the medical device. In addition, the rotational assembly 150B includes a distal shaft 156B that extends distally from the distal flange 154B and defines at least the distal portion of the inner cavity of the rotational assembly 150B. The rotational assembly 150B differs from the above-mentioned rotational assembly 150A in that the distal flange 154B is defined by a single continuous curved edge extending around the periphery of the body 152B.

[0058] The end cap 130B may include a body 132B having one or more alignment features (alignment structures) 138B arranged along the exterior of the body 132B. In this example, the end cap 130B includes a pair of alignment features 138B, however, it should be understood that the end cap 130B may include more and / or fewer alignment features 138B without departing from the scope of the present disclosure. The pair of alignment features 138B is configured to engage with corresponding features of one or more other components of the medical device 100, thereby facilitating the alignment and / or engagement of the end cap 130B with components of the medical device 100 (e.g., a rotating assembly cover (not shown) configured to enclose the rotating assembly 150A therein, the cover 120A, etc.). For example, the rotating assembly cover can be a component of the needle 179, and the alignment features 138B can engage with the rotating assembly cover as a rotation stop.

[0059] Still refer to Figure 4, the end cap 130B may also include a protrusion 137B, and one or more locks 139B extending near the proximal end of the body 132B. In this example, the end cap 130B includes a pair of locks 139B, wherein each lock 139B is circumferentially arranged at a position adjacent to the protrusion 137B at the proximal end of the body 132B. The size and shape of the protrusion 137B are designed according to the profile of the distal flange 154B of the rotation assembly 150B, so that the protrusion 137B is configured to receive the distal flange 154B therein. The pair of locks 139B can be flexibly moved relative to the protrusion 137B, and are configured to engage with the distal flange 154B to couple the end cap 130B to the rotation assembly 150B in response to the distal flange 154B being received and abutting against the protrusion 137B. In some examples, the pair of locks 139B may include protrusions extending radially inward relative to the protrusions 137B such that the protrusions of the locks 139B may operably abut the distal flange 154B to secure the rotation assembly 150B to the end cap 130B.

[0060] The end cap 130B also includes a mating interface 140B at the proximal end of the body 132B, the body 132B having one or more curved arms 142B extending inwardly into the inner cavity of the end cap 130B. In this example, the curved arms 142B of the mating interface 140B are substantially similar to the curved arms 142 of the mating interface 140A on the end cap 130A illustrated and described above. The distal shaft 156B of the rotation assembly 150B includes one or more ridges 158B and corresponding grooves formed between adjacent pairs of ridges 158B. In this example, the ridges 158B and the distal shaft 156B of the rotation assembly 150B are substantially similar to the ridges 158A and the distal shaft 156A of the rotation assembly 150A illustrated and described above. Therefore, similar to the description above regarding the rotation assembly 150A and the end cap 120, the rotation assembly 150B is configured and operable to interact with the end cap 130B.

[0061] Now refer to Figure 5 , an example of a cover 120C, an end cap 130C, and a rotating assembly 150C are illustrated and described herein. It should be understood that, unless otherwise expressly stated herein, the cover 120C, the end cap 130C, and the rotating assembly 150C may be constructed and operated similarly to the cover 120A, the end cap 130A, and the rotating assembly 150A described above, respectively, and thus similar features are labeled with corresponding numbers. For example, the rotating assembly 150C may include a body 152C defined by a proximal end 151C and a distal flange 154C, wherein the proximal end 151C includes a proximal opening 153C ( Figure 6), the proximal opening facilitates access to the lumen of the rotational assembly 150C. In addition, the rotational assembly 150C includes a distal shaft 156C extending distally from the distal flange 154C. The rotational assembly 150C differs from the above-described rotational assembly 150A in that the distal shaft 156C includes one or more orifices 158C formed thereon. The distal shaft 156C of the rotational assembly 150C includes a plurality of orifices / grooves 158C extending along an annular array around the exterior of the distal shaft 156C. It should be understood that the plurality of orifices / grooves 158C may be spaced apart from one another at any suitable interval along the distal shaft 156C of the rotational assembly 150C.

[0062] The cover 120C may include a body 122C defined by a distal opening 124C and a proximal opening 126C. The size, shape, and configuration of the distal opening 124C are designed to receive the rotation assembly 150C and the end cap 130C therethrough. The body 122C also includes a groove 128C, the size and shape of which are designed to receive one or more components of the end cap 130C therethrough (e.g., the pin housing 134C). The body 122C of the cover 120C also includes one or more openings 129C, which pass through the exterior of the body 122C and enter the interior cavity of the body 122C. As further described below, the cover 120C includes a pair of openings 129C, each of which is configured to receive a fastener (not shown) therethrough for connecting the cover 120C to another component of the medical system 100, such as the end cap 130C ( Figure 6 ).

[0063] Still refer to Figure 5 , the end cap 130C may include a body 132C having a pin housing 134C extending outwardly therefrom and one or more engagement tabs 137C extending distally from a distal end of the body 132C. In this example, the end cap 130C includes a pair of engagement tabs 137C extending distally from the distal end of the body 132C, wherein the engagement tabs 137C are arranged around the inner cavity of the body 132C. It should be understood that the pair of engagement tabs 137C are configured to align and / or engage the end cap 130C with the handle 110 of the medical system 100. For example, the pair of engagement tabs 137C can be operably engaged with the outer body 112 of the handle 110, thereby coupling the end cap 130C to the outer body 112.

[0064] The end cap 130C may also include one or more openings 138C, 139C formed through the exterior of the body 132C such that the openings 138C, 139C extend into the interior cavity of the body 132C. The end cap 130C includes a pair of distal openings 138C and a pair of proximal openings 139C, wherein the distal opening 138C is located closer to the distal end of the body 132C relative to the proximal opening 139C and the proximal opening 139C is located closer to the proximal end of the body 132C relative to the distal opening 138C. As further described below, the pair of distal openings 138C are each configured to receive a fastener (not shown) therethrough for coupling the end cap 130C to another component of the medical system 100, such as the cover 120C ( Figure 6 ). In this example, the end cap 130C also includes a stopper (detent) 140C. The size, shape, and configuration of the stopper are designed to be received in the inner middle of at least one of the proximal openings 139C. As described in more detail herein, the stopper 140C is configured to engage with at least one of the plurality of grooves 158C along the distal axis 156C of the rotational assembly 150C in response to the end cap 130C receiving the rotational assembly 150C therethrough. In some examples, the stopper 140C may include a ball and / or protrusion structure coupled to the distal end of the spring and / or biasing mechanism. In this case, the ball / protrusion at the distal end of the spring may be a portion of the stopper 140C received inside the groove 158C. In other examples, the stopper 140C may include an elastic protrusion that can expand and compress longitudinally.

[0065] Now refer to Figure 6, the stopper 140C is depicted as being inside the proximal opening 139C and engaging with at least one of the plurality of grooves 158C. In this case, the stopper 140C, when received in the groove 158C, at least partially maintains the rotational assembly 150C in a fixed radial position (e.g., orientation) relative to the cover 120C, the end cap 130C, and / or the handle 110. The distal flange 154C of the rotational assembly 150C is located between the proximal end of the cover 120C and the proximal end of the end cap 130C and is engaged by these proximal ends. The distal flange 154C is received inside the cavity 133C formed between the proximal end of the cover 120C and the proximal end of the end cap 130C. In this case, the rotational assembly 150C is axially and longitudinally fixed relative to the cover 120C and the end cap 130C. It should be understood that in other examples, the end cap 130C may include more stops 140C (e.g., inside other proximal openings 139C of the body 132C). As described above, since the cover 120C is disposed above the end cap 130C, a pair of openings 129C on the body 122C of the cover 120C may be aligned with a pair of distal openings 138C on the end cap 130C of the body 132C. In this case, fasteners (not shown) may be received through the corresponding openings 129C, 138C to fasten the cover 120C to the end cap 130C.

[0066] According to an exemplary method of using the cover 120C, the end cap 130C, and the rotation assembly 150C with the medical system 100 during surgery, when the rotation assembly 150C is received through the interior of the end cap 130C, the stopper 140C can engage with the distal shaft 156C. The stopper 140C is biased toward the distal shaft 156C and is received inside at least one groove of the plurality of grooves 158C. The rotation assembly 150C is configured to move (e.g., push) the stopper 140C out of the groove 158C (the spring compressing the stopper 140C) when the distal shaft 156C rotates inside the end cap 130C. The rotation of the rotation assembly 150C can cause the stopper 140C to leave the groove 158C and be received along the outer surface (i.e., the space) of the distal shaft 156C disposed between a pair of adjacent grooves 158C.

[0067] In this case, the outer surface of the distal shaft 156C can abut the stop 140C, thereby applying a radially outward force on the stop 140C (thereby compressing the spring). In this case, rotating the assembly 150C can cause the ball / protrusion of the stop 140C to move out of the groove 158C until the ball / stop is aligned with at least another groove 158C along the distal shaft 156C. Receiving the stop 140C in the groove 158C on the distal shaft 156C can at least partially fix the radial orientation of the rotation assembly 150C relative to the cover 120C, the end cap 130C, and the handle 110. It should be understood that when the stop 140C is biased toward and received within the at least one groove 158C on the distal shaft 156C, the groove 158C and the stop 140C jointly prevent further rotation of the rotation assembly 150C.

[0068] In this example, the rotation assembly 150C is configured to generate indexing feedback as the rotation assembly 150C is rotated relative to the cover 120C, the end cap 130C, and / or the handle 110. For example, when the stopper 140C of the end cap 130C is received within at least one opening of the aperture 158C on the distal shaft 156C and / or during the rotation of the rotation assembly 150C, the user of the medical system 100 can feel tactile and / or audible feedback at the body 152C of the rotation assembly 150C. In this case, the user of the medical system 100 can progressively indicate the radial position (e.g., orientation) of the medical device 170 (e.g., the cannula 176 and the needle 179) relative to the handle 110 (when it is disposed within the cannula 176) by receiving the indexing feedback.

[0069] It should be understood that the plurality of grooves 158C included along the distal shaft 156C form a plurality of predetermined angular intervals at which the rotation assembly 150C (and the medical device 170) can be positioned. In addition, the plurality of grooves 158C on the distal shaft 156C are configured to prevent movement of the rotation assembly 150C at each of the plurality of predetermined angular intervals by engaging the stopper 140C within at least one of the plurality of grooves 158C. The stopper 140C can provide a force for maintaining the rotation assembly 150C in at least one of the predetermined angular intervals. This force can be overcome by applying a predetermined rotational force on the body 152C that is greater than the force applied by the spring of the stopper 140C, thereby allowing movement of the rotation assembly 150C and the sleeve 176 relative to the handle 110.

[0070] Now refer to Figure 7 to Figure 9, an example of a cover 120D, an end cap 130D, and a rotating assembly 150D are illustrated and described herein. It should be understood that, unless otherwise expressly stated herein, the cover 120D, the end cap 130D, and the rotating assembly 150D may be configured and operate similarly to the cover 120A, the end cap 130A, and the rotating assembly 150A described above, respectively, and thus similar features are indicated by corresponding numbers. For example, referring to Figure 7 , the end cap 130D may include a body 132D that defines an inner cavity 139D extending between a proximal end and a distal end of the body 132D. The proximal end of the body 132D may include a mating interface 140D having a proximal-facing protrusion 142D extending radially inwardly into the inner cavity 139D of the body 132D. The protrusion 142D of the mating interface 140D extends into the inner cavity 139D to the extent that the protrusion 142D at least partially defines the size (e.g., diameter) and shape of the inner cavity 139D.

[0071] The mating interface 140D may also include two or more proximally facing orifices / grooves 144D formed on the protrusion 142D. In this example, the mating interface 140D includes a plurality of orifices / grooves 144D arranged along the protrusion 142D and facing the proximal end of the end cap 130D. The plurality of orifices / grooves 144D may be spaced circumferentially from each other along the mating interface 140D so that adjacent orifices / grooves 144D are offset relative to each other at various suitable intervals. As further described herein, the size and shape of each orifice / groove of the plurality of orifices / grooves 144D is designed in accordance with the size and shape of one or more components (e.g., protrusion 158D) of the rotation assembly 150D. In some examples, one or more orifices / grooves in the plurality of orifices / grooves 144D may include sizes and / or shapes (e.g., spherical, cubic, and / or other complementary shapes) that are different from each other and correspond to the size and / or shape of the protrusion 158D. It should be appreciated that in other examples, the protrusion 142D on the end cap 130D may include more and / or fewer apertures / recesses 144D than illustrated and described herein without departing from the scope of the present disclosure.

[0072] Still refer to Figure 7, the end cap 130D may also include one or more alignment features 138D arranged along the outer surface of the body 132D. In this example, the end cap 130D includes a pair of alignment features 138D, however it should be understood that the end cap 130D may include more and / or fewer alignment features 138D without departing from the scope of the present invention. The pair of alignment features 138D is configured to engage with corresponding features of one or more components of the medical device 100, thereby facilitating the alignment and / or engagement of the end cap 130D with corresponding components (e.g., a rotating assembly cover (not shown), a cover 120D, etc.). For example, the rotating assembly cover can be a component of the needle 179, and the alignment features 138D can engage with the rotating assembly cover as a rotation limiter.

[0073] Now refer to Figure 8 , the rotational assembly 150D may include a body 152D defined by a proximal end 151D and a distal flange 154D, wherein the proximal end 151D includes a proximal opening 153D (see Fig. 9 ), the proximal opening 153D facilitates access to the lumen of the rotational assembly 150D. In addition, the rotational assembly 150D includes a distal shaft 156D extending distally from the distal flange 154D. The rotational assembly 150D differs from the above-described rotational assembly 150A in that the distal flange 154D includes one or more distally facing protrusions 158D formed thereon. The distal flange 154D of the rotational assembly 150D includes a pair of protrusions 158D that extend outwardly from the outer surface of the distal flange 154D opposite the body 152D. It should be understood that in other examples, the rotational assembly 150D may include more and / or fewer protrusions 158D than those illustrated and described herein along various other suitable surfaces. In examples where the rotational assembly 150D includes a plurality of protrusions 158D, it will be appreciated that the protrusions 158D may be circumferentially spaced from one another along the protrusion 142D of the mating interface 142D by distances corresponding to the areas between adjacent apertures / recesses 144D.

[0074] Now refer to Fig. 9And as described above, the size, shape, and configuration of the protrusion 158D are designed to be received within one or more apertures / recesses 144D along the protrusion 142D of the mating interface 140D when the rotational assembly 150D is received in the end cap 130D. In this case, the protrusion 158D at least partially maintains a fixed radial position (e.g., orientation) of the rotational assembly 150D relative to the cover 120D, the end cap 130D, and / or the handle 110 when it is received within at least one of the plurality of apertures / recesses 144D on the protrusion 142D. When the protrusion 158D is received within the apertures / recesses 144D formed thereon, the distal flange 154D is received along the protrusion 142D of the mating interface 140D and engages with the protrusion 142D.

[0075] One or more washers 157D disposed between the outer surface of the distal flange 154D opposite the protrusion 142D and the inner surface of the cover 120D maintain the distal flange 154D in abutment against the protrusion 142D of the end cap 130D. In this example, the one or more washers 157D include an O-ring formed of an elastomer, which is configured to push and / or urge the distal flange 154D of the rotational assembly 150D against the protrusion 142D of the end cap 130D when the cover 120D is coupled to the end cap. In other words, the attachment of the cover 120D to the end cap 130D can generate a force, thereby limiting the movement of the one or more washers 157D (e.g., O-rings) and causing elastic deformation of the one or more washers 157D to provide linear motion of the rotational assembly 150D.

[0076] Still refer to Fig. 9 , the cover 120D of this example includes a single gasket 157D, however it should be understood that more gaskets 157D can be included between the cover 120D and the distal flange 154D than those illustrated and described herein. For example, it should be understood that in other examples, the gasket 157D can be completely omitted from between the cover 120D and the rotating assembly 150D, and / or include various other deformable or spring-like devices other than the O-rings described herein. In addition and as described in detail below, as a compressive force is applied thereto (e.g., the distal flange 154D and / or the cover 120D), the gasket 157D is operable to bend and deform, thereby allowing the protrusion 158D to separate from the orifice / recess 144D.

[0077] According to an exemplary method of using the cover 120D, the end cap 130D, and the rotation assembly 150D of the medical system 100 during surgery, the medical system 100 can first be inserted into a patient and manipulated so that the medical device 170 received inside the handle 110 is located adjacent to the target treatment site. Since the distal shaft 156D of the rotation assembly 150D extends through the lumen of the end cap 130D, the protrusion 158D of the rotation assembly 150D can engage and / or be received in at least one of the plurality of apertures / recesses 144D on the end cap 130D. The protrusion 158D is biased outward from the distal flange 154D and is received inside at least one of the plurality of apertures / recesses 144D on the protrusion 142D. The rotation assembly 150D is configured to move the protrusion 158 out of the aperture / recess 144D (e.g., rotate) when the distal shaft 156D is rotated inside the end cap 130D.

[0078] Rotation of the rotating assembly 150D may cause the protrusion 158D to leave the aperture / recess 144D and be received between a pair of adjacent apertures / recesses 144D along the outer surface of the protrusion 142D. In this case, the outer surface of the protrusion 142D may abut against the protrusion 158D, thereby applying a proximal force on the distal flange 154D of the rotating assembly 150D. In this case, the rotating assembly 150D may move proximally relative to the cover 120D and the end cap 130D so that the distal flange 154D abuts against the gasket 157D disposed between the cover 120D and the distal flange 154D. As a result, when a pair of protrusions 158D are not received inside at least one aperture / recess 144D on the protrusion 142D (high energy state), the distal flange 154D may cause the gasket 157D to compress until it becomes aligned with at least another aperture / recess 144D (low energy state). The compression of the washer 157D places the rotational assembly 150D in a high energy state compared to a low energy state when the pair of protrusions 158D are received within the at least one aperture / recess 144D and the washer 157D is not compressed.

[0079] Receiving at least a portion of a pair of protrusions 158D in apertures / recesses 144D of mating interface 140D can at least partially fix the radial orientation of rotational assembly 150D relative to cover 120D, end cap 130D, and handle 110. It should be understood that when protrusions 158D are biased toward and received within at least one aperture / recess 144D on protrusion 142D, apertures / recesses 144D and protrusions 158D can collectively prevent further rotation of rotational assembly 150D. In this case, gasket 157D can expand, thereby placing rotational assembly 150D in a low-energy state.

[0080] In this example, the rotation assembly 150D is configured to generate indexed feedback as the rotation assembly 150D is rotated relative to the cover 120D, the end cap 130D, and / or the handle 110. For example, when the protrusion 158D on the distal flange 154D is received within the at least one aperture / recess 144D on the protrusion 142D of the end cap 130D and / or during the rotation of the rotation assembly 150D, the user of the medical system 100 can feel tactile and / or audible feedback at the body 152D of the rotation assembly 150D. In this case, the user of the medical system 100 can progressively indicate the radial position (e.g., orientation) of the medical device 170 (e.g., the cannula 176 and the needle 179, when disposed within the cannula 176) relative to the handle 110 by receiving the indexed feedback.

[0081] It should be understood that the plurality of apertures / recesses 144D included along the protrusion 142D of the mating interface 140D form a plurality of predetermined angular gaps in which the rotational assembly 150D (and the medical device 170) can be positioned. In addition, the plurality of apertures / recesses 144D on the end cap 130D are configured to prevent the rotational assembly 150D from moving at each of the plurality of predetermined angular gaps by engaging the protrusion 158D in at least one of the plurality of apertures / recesses 144D. The apertures / recesses 144D and / or the protrusions 158D may collectively provide a force for maintaining the rotational assembly 150D in at least one of the predetermined angular gaps. This force may be overcome by applying a rotational force (such as a rotational force generated by compression of the gasket 157D) on the body 152D that is greater than the force applied by the apertures / recesses 144D and / or the protrusions 158D, thereby allowing the rotational assembly 150D and the sleeve 176 to move relative to the handle 110.

[0082] Now refer to Figure 10-11 , an example of a rotational assembly 150E is illustrated and described herein. It should be understood that the rotational assembly 150E of this example can be combined with the cover 120D and the end cap 130D illustrated and described above. It should also be understood that unless otherwise expressly indicated herein, the rotational assembly 150E can be configured and operate similarly to the rotational assembly 150A described above, and thus similar features are labeled with corresponding numbers. For example, the rotational assembly 150E may include a body 152E defined by a proximal end 151E and a distal flange 154E, wherein the proximal end 151E includes a proximal opening 153E (see Fig.11 ), the proximal opening 153E facilitates access to the inner cavity of the rotation assembly 150E. In addition, the rotation assembly 150E includes a distal shaft 156E extending distally from the distal flange 154E.

[0083] The rotational assembly 150E differs from the rotational assembly 150A described above in that the distal flange 154E includes one or more detents (detents) 158E formed thereon or attached thereto. The distal flange 154E of the rotational assembly 150E includes a detent 158E that extends outwardly from an outer surface of the distal flange 154E opposite the body 152E. It should be understood that in other examples, the rotational assembly 150E may include more detents 158E along various other suitable surfaces illustrated and described herein. Furthermore, it should be understood that in other examples, one or more detents 158E may be formed on one or more other components of the medical device 100 that are different from the rotational assembly 150E. The detent 158E of the rotational assembly 150E is biased to an extended state relative to the outer surface of the distal flange 154E, such as Fig.10 as shown in .

[0084] The stopper 158E of the rotating assembly 150E is deformable in a flexural manner so that the stopper 158E is configured to deform (e.g., compress) from an extended state to a retracted state when, for example, a predetermined force is applied thereto. In some instances, the stopper 158E may include a sphere and / or a protruding feature connected to the distal end of the spring and / or the biasing mechanism. In this case, the sphere / protrusion at the distal end of the spring may be a part of the stopper 158E received inside the orifice / recess 144D. In other instances, the stopper 158E may include an elastic protrusion that can be longitudinally expanded and contracted. In other instances, the stopper 158E may be a screw that is screwed into the distal flange 154E so that the stopper 158E is configured to be transformed from an extended state to a retracted state by rotating outwardly and / or inwardly relative to the distal flange 154E, respectively.

[0085] Now refer to Fig.11 And as described above, the size, shape, and configuration of the stop 158E are designed to be received within one or more apertures / recesses 144D along the protrusion 142D of the mating interface 142D when the rotational assembly 150E is received in the end cap 130D. In this case, the stop 158E at least partially holds the rotational assembly 150E in a fixed position (e.g., orientation) relative to the cover 120D, the end cap 130D, and / or the handle 110 when it is received within at least one of the plurality of apertures / recesses 144D on the protrusion 142D. When the stop 158E is received within at least one of the plurality of apertures / recesses 144D formed thereon, the distal flange 154E of the rotational assembly 150E is received along the protrusion 142D of the mating interface 140D and engages with the protrusion 142D.

[0086] According to an exemplary method of using the cover 120D, the end cap 130D, and the rotation assembly 150E of the medical system 100 during surgery, when the distal shaft 156E of the rotation assembly 150E extends through the inner cavity of the end cap 130D, the stopper 158E can engage and / or be received in at least one of the plurality of apertures / recesses 144D. The stopper 158E is offset distally and outwardly from the distal flange 154E and is at least partially received within at least one of the plurality of apertures / recesses 144D on the protrusion 142D. In this case, the size and shape of the apertures / recesses 144D are designed so that the stopper 158E can only be partially located within the apertures / recesses 144D. Therefore, the distal flange 154E is deflected from the protrusion 142D, thereby forming a space and / or gap between the distal flange 154E and the protrusion 142D when the stopper 158E is in the extended state. The rotation assembly 150E is configured to move the stop 158 out of the aperture / recess 144D (compressing the spring of the stop 158E) when the distal shaft 156E is rotated inside the end cap 130D.

[0087] Rotation of the rotational assembly 150E may cause the stopper 158E to leave the aperture / recess 144D and be received between a pair of adjacent apertures / recesses 144D along the outer surface of the protrusion 142D. In this case, the stopper 158E may abut against the outer surface of the protrusion 142D, thereby applying a longitudinal proximal force on the stopper 158E of the rotational assembly 150E (thereby compressing the spring). In this case, the space / gap between the distal flange 154E and the protrusion 142D provides a spatial clearance for the stopper 158E to transition from an extended state to a retracted state by compression. It should be understood that due to the compression of the stopper 158E, the movement of the rotational assembly 150E relative to the cover 120D and the end cap 130D is minimal. Thus, when the stopper 158E is in the retracted state, the distal flange 154E is deflected from the protrusion 142D of the mating interface 140D until it becomes aligned with at least another aperture / recess 144D. Receiving at least a portion of the stopper 158E in at least one aperture 144D of the mating interface 140D can at least partially fix the radial orientation of the rotational assembly 150E relative to the cover 120D, the end cap 130D, and the handle 110. It should be understood that when the stopper 158E is biased toward and received within at least one aperture / recess 144 on the protrusion 142D, the aperture 144D and the stopper 158E can collectively prevent further rotation of the rotational assembly 150E.

[0088] In this example, the rotation assembly 150E is configured to generate indexed feedback as the rotation assembly 150E rotates relative to the cover 120D, the end cap 130D, and / or the handle 110. For example, when the stop 158E on the distal flange 154E is received within at least one of the apertures / recesses 144D on the protrusion 142D of the end cap 130D and / or during the rotation of the rotation assembly 150E, the user of the medical system 100 can feel tactile and / or audible feedback at the body 152E of the rotation assembly 150E. In this case, the user of the medical system 100 can progressively indicate the radial position (e.g., orientation) of the medical device 170 (e.g., cannula 176 and needle 179) relative to the handle 110 by receiving the indexed feedback.

[0089] It should be understood that the plurality of apertures / recesses 144D included along the protrusion 142D of the mating interface 140D form a plurality of predetermined angular gaps in which the rotational assembly 150E (and the medical device 170) can be positioned. In addition, the plurality of apertures / recesses 144D on the end cap 130D are configured to prevent the rotational assembly 150E from moving at each of the plurality of predetermined angular gaps by engaging the stopper 158E within at least one of the plurality of apertures / recesses 144D. The apertures / recesses 144D and / or the stopper 158E can provide a combined force for maintaining the rotational assembly 150E in at least one of the predetermined angular gaps. This force is overcome by applying a rotational force on the body 152E that is greater than the force applied by the apertures / recesses 144D and / or the stopper 158E, thereby allowing movement of the rotational assembly 150E and the sleeve 176 relative to the handle 110.

[0090] Now refer to Fig.12 , an example of a cover 120F, an end cap 130F, and a rotating assembly 150F is disclosed and described herein. It should be understood that, unless otherwise expressly stated herein, the cover 120F, the end cap 130F, and the rotating assembly 150F can be respectively configured and operated similarly to the cover 120A, the end cap 130A, and the rotating assembly 150A described above, and thus similar features are labeled with corresponding numbers. For example, the rotating assembly 150F may include a body 152F defined by a proximal end 151F and a distal flange 154F, wherein the proximal end 151F includes a proximal opening 153F ( Figure 13-14 ). In addition, the rotation assembly 150F includes a distal shaft 156F extending distally from the distal flange 154F.

[0091] The rotational assembly 150F differs from the above-described rotational assembly 150A in that the distal flange 154F includes one or more deflectable and / or flexible arms 158F formed thereon. The distal flange 154F of the rotational assembly 150F includes a pair of flexible arms 158F extending outwardly from the peripheral edge of the distal flange 154F. In this example, the size, shape, and configuration of each wall of the pair of flexible arms 158F are designed to be received inside one or more components (e.g., opening 144F) of the end cap 130F. As described in more detail herein, each arm of the pair of flexible arms 158F is configured to engage with one or more components of the end cap 130F when the end cap 130F receives the rotational assembly 150F. For example, as the rotational assembly 150F is inserted into the end cap 130F, the flexible arms 158F are operably engaged with a pair of protrusions 142F of the end cap 130F.

[0092] Still refer to Fig.12 , the cover 120F may include a body 122F defined by a distal opening 124F and a proximal opening 126F. The size, shape, and configuration of the distal opening 124F are designed to receive the rotation assembly 150F and the cover 130F therethrough. The body 122F also includes a side window 125F and one or more apertures 128F along the side wall of the cover 120F. The size and shape of the side window 125F are designed to receive one or more components (e.g., a pin housing 134F) of the end cap 130F therethrough. The end cap 130F may include a body 132F having a pin housing 134F extending outwardly therefrom and one or more engagement tabs 137F extending radially outwardly from the body 132F. The size, shape, and configuration of the one or more engagement tabs 137F are designed to engage with the proximal end of the outer body 112, thereby coupling the end cap 130F to the handle 110. Additionally and / or alternatively, one or more engagement tabs 137F may be configured to engage one or more apertures 128F formed along a sidewall of the cover 120F, thereby coupling the end cap 130F to the cover 120F.

[0093] The end cap 130F may also include a mating interface 140F along the proximal end of the end cap 130F. As described above, the mating interface 140F of the end cap 130F may include one or more proximal-facing protrusions 142F and one or more proximal-facing grooves 144F formed thereon. It should be understood that the protrusions 142F and the grooves 144F are alternating to form and define the grooves 144F. The mating interface 140F includes a plurality of protrusions 142F and a plurality of grooves 144F formed along the proximal end of the body 132F, wherein at least one groove 144F is located between an adjacent pair of protrusions 142F. As described in more detail herein, the size, limitation, and configuration of each groove of the plurality of grooves 144F are designed to receive at least one flexible arm 158F of the rotational assembly 150F between an adjacent pair of protrusions 142F when the end cap 130F is coupled to the rotational assembly 150F.

[0094] like Fig.13 As best seen in the , the rotation assembly 150F includes at least one slot 159F disposed between the distal flange 154F and each arm of the flexible arms 158F. The flexible arms 158F of the rotation assembly 150F are configured to extend outwardly from the distal flange 154F relative to the size, shape, and configuration of the at least one slot 159F. As further described herein, each flexible arm 158F moves relative to the distal flange 154F as the slot 159F disposed therebetween expands and / or compresses. Therefore, it should be understood that the flexible arms 158F and / or slots 159F can deform relative to the distal flange 154F, and that movement of the flexible arms 158F can increase and / or decrease the size of the slots 159F.

[0095] Now refer to Fig.14 , the rotating assembly 150F is depicted as being inside the end cap 130F, wherein the flexible arm 158F is received inside at least one groove of the plurality of grooves 144F. In this case, when received inside the groove 144F, the flexible arm 158F at least partially maintains the rotating assembly 150F in a fixed radial position (e.g., orientation) relative to the cover 120F, the end cap 130F, and / or the handle 110. The distal flange 154F of the rotating assembly 150F is arranged between the proximal end of the cover 120F and the proximal end of the end cap 130F, and is engaged by these two ends. In this case, the rotating assembly 150F is longitudinally and axially fixed relative to the cover 120F and the end cap 130F. It should be understood that in other examples, the rotating assembly 150F may include more and / or fewer flexible arms 158F on the distal flange 154F.

[0096] According to an exemplary method of using the cover 120F, the end cap 130F, and the rotation assembly 150F of the medical system 100 during surgery, when the distal shaft 156F of the rotation assembly 150F is received through the inner cavity of the end cap 130F, the flexible arm 158F of the distal flange 154F can be engaged along the groove 144F of the mating interface 140F. The flexible arm 158F is biased outward from the distal flange 154F and is received inside at least one groove of the plurality of grooves 144F. In this case (where each flexible arm 158F is arranged inside at least one groove 144F), the flexible arm 158F is maintained in an extended state. The rotation assembly 150F is configured to move the flexible arm 158F out of the groove 144F when the distal shaft 156F is rotated inside the end cap 130F.

[0097] Rotation of the rotation assembly 150F may cause the flexible arms 158F to move radially inward and out of the grooves 144F and align with at least one protrusion 142F of the mating interface 140F. In this case, the flexible arms 158F may abut against the protrusions 142F, thereby exerting an inward radial force on the flexible arms 158F. In this case, the end cap 130F may cause the flexible arms 158F to transition from an extended state to a compressed state until they become aligned with at least another groove 144F between a pair of protrusions 142F. In the compressed state, as the flexible arms 158F move radially inward toward the distal flange 154F, at least one slot 159F disposed between the distal flange 154F and each flexible arm 158F is deformed.

[0098] Receiving at least a portion of each flexible arm 158F in at least one groove 144F can at least partially fix the radial orientation of the rotating assembly 150F relative to the cover 120F, the end cap 130F, and the handle 110. It should be understood that when the flexible arm 158F is biased toward and received within the at least one groove 144F on the end cap 130F, the protrusion 142F, the groove 144F, and the flexible arm 158F can collectively prevent further rotation of the rotating assembly 150F.

[0099] In this example, the rotation assembly 150F is configured to generate indexed feedback as the rotation assembly 150F is rotated relative to the cover 120F, the end cap 130F, and / or the handle 110. For example, when the flexible arm 158 on the distal flange 154F is received in the at least one groove 144F on the end cap 130F and / or during the rotation of the rotation assembly 150F, the user of the medical system 100 can feel tactile and / or audible feedback at the rotation assembly 150F of the body 152F. In this case, the user of the medical system 100 can progressively indicate the radial position (e.g., orientation) of the medical device 170 (e.g., the cannula 176 and the needle 179, when disposed inside the cannula 176) relative to the handle 110 by receiving the indexed feedback.

[0100] It should be appreciated that the plurality of grooves 144F included along the mating interface 140F form a plurality of predetermined angular gaps (angular gaps, angular intervals) at which the rotational assembly 150F (and the medical device 170) can be positioned. In addition, the plurality of grooves 144F are configured to prevent movement of the rotational assembly 150F at each of the plurality of predetermined angular gaps by engaging the flexible arm 158F between a pair of adjacent protrusions 142F. The protrusions 142F, the grooves 144F, and / or the flexible arms 158F may collectively provide a force for maintaining the rotational assembly 150F in at least one predetermined angular gap. The force may be overcome by applying a rotational force on the body 152F that is greater than the force applied by the protrusions 142F, the grooves 144F, and / or the flexible arms 158F, thereby allowing movement of the rotational assembly 150F and the sleeve 176 relative to the handle 110.

[0101] Each of the aforementioned devices, assemblies, and methods can be used to facilitate reaching a target treatment site and provide enhanced control of auxiliary tools / devices for use at the target treatment site. By providing a medical device with a rotational assembly capable of controlling multiple tools / devices of the medical device, which are coupled to the medical device at predetermined angular gaps, a user can utilize the various tools / devices of the medical device to interact with the target treatment site during surgery and receive position feedback of the tools / devices. In this case, the user can reduce the overall surgical time, improve the efficiency of the surgery, and / or avoid unnecessary harm to the patient's body due to limited control of the auxiliary tools / devices.

[0102] It will be apparent to those skilled in the art that various modifications and variations may be made in the disclosed apparatus and methods without departing from the scope of the present disclosure. Other aspects of the present disclosure will be apparent to those skilled in the art based on consideration of this specification and implementation of the features disclosed herein. It is intended that this specification and examples be considered to be exemplary only.

Claims

1. A medical device comprising: casing; a tool within the casing and movable relative to the casing; and a handle including a rotation assembly configured to rotate the tool relative to the cannula as the rotation assembly rotates relative to a portion of the handle; wherein the rotating assembly rotates the tool relative to the casing at a predetermined angular clearance and prevents movement at each angular clearance of the predetermined angular clearance, wherein the rotational assembly comprises a body and a distal shaft, the body being defined by a distal flange and a proximal end, the body comprising one or more features arranged along the exterior of the rotational assembly, which features are configured to facilitate manual operation of the rotational assembly, and wherein the distal shaft extends outwardly from the distal flange away from the body and the proximal end of the rotational assembly.

2. The medical device of claim 1, wherein the rotation assembly holds the tool in at least one of the predetermined angular gaps to secure the tool relative to the cannula.

3. The medical device of claim 2, wherein the rotating assembly releases the tool from at least one of the predetermined angular gaps as a predetermined rotational force is applied to the rotating assembly.

4. The medical device of any one of the preceding claims, wherein the rotating assembly generates at least one of tactile, audible, or visual feedback when the rotating assembly rotates between the predetermined angular gaps.

5. The medical device according to any one of claims 1 to 3, wherein: The shaft has a plurality of ridges circumferentially alternating with a plurality of grooves; The handle includes one or more arms; Each of the one or more arms is configured to engage the plurality of ridges and the plurality of grooves; and The swivel assembly resists rotational movement between the swivel assembly and the portion of the handle when a first arm of the one or more arms is positioned in a first recess of the plurality of recesses.

6. The medical device according to claim 5, wherein: When the first arm is in the first groove, applying a rotational force to the rotation assembly relative to the portion of the handle causes the first arm to exit the first groove and cause the first arm to be located in a second groove circumferentially adjacent to the first groove.

7. The medical device of claim 5, wherein the one or more arms include a plurality of arms extending radially inwardly into the lumen of the handle.

8. The medical device of claim 5, wherein each arm of the plurality of arms is deflected relative to each arm of the remaining plurality of arms.

9. The medical device according to any one of claims 1 to 2, wherein: The rotating component includes a plurality of grooves or apertures arranged on an outer surface of the rotating component; The handle includes one or more stops configured to engage with the plurality of grooves or apertures; and The rotational assembly prevents rotational movement between the rotational assembly and the portion of the handle when a first stop of the one or more stops is located in a first recess or aperture of the plurality of recesses or apertures.

10. The medical device of claim 9, wherein: The first stopper includes a compressible portion; and When the first stop is located in the first groove or aperture, applying a rotational force to the rotating assembly relative to the portion of the handle causes the first stop to compress and leave the first groove, and causes the first stop to be located in a second groove or aperture circumferentially adjacent to the first groove or aperture.

11. The medical device according to any one of claims 1 to 2, wherein: A protrusion extends distally from the distal flange; The handle includes a proximally facing flange having a plurality of circumferentially spaced grooves or apertures; and The protrusion is configured to be received by each of the plurality of recesses or apertures, such that rotational movement between the rotational assembly and the portion of the handle is prevented when the protrusion is received by one of the plurality of recesses or apertures.

12. The medical device of claim 11, further comprising a deformable member disposed proximal to the distal flange, wherein: the deformable member biasing the distal flange toward the proximally facing flange; and When the protrusion is located in the first groove or orifice, applying a rotational force to the rotational assembly relative to the portion of the handle causes the deformable member to compress, causing the protrusion to leave the first groove or orifice, and causing the protrusion to be located in a second groove or orifice circumferentially adjacent to the first groove or orifice.

13. The medical device of claim 12, wherein: The protrusion includes a compressible portion; and When the protrusion is located in the first groove or aperture, applying a rotational force to the rotating assembly relative to the portion of the handle causes the protrusion to compress and leave the first groove or aperture, and causes the protrusion to be located in a second groove or aperture circumferentially adjacent to the first groove or aperture.

14. The medical device according to any one of the preceding claims 1 to 2, wherein: The handle includes a plurality of protrusions and a plurality of grooves; The plurality of protrusions and the plurality of grooves alternate with each other; The rotational assembly includes a compressible member; and The compressible member is configured to be received by each of the plurality of grooves such that when the protrusion is received by one of the plurality of grooves, rotational movement between the rotation assembly and the portion of the handle is prevented.

15. The medical device of claim 14, wherein: The distal flange of the rotation assembly has a groove enclosed by the distal flange; the compressible member including a perimeter of the flange defining at least a portion of the slot; and When the compressible member is located in the first groove, applying a rotational force to the rotational assembly relative to the portion of the handle causes the compressible member to be compressed radially inward while reducing the volume of the groove, causing the compressible member to leave the first groove, and causing the compressible member to be located in a second groove circumferentially adjacent to the first groove or orifice.

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