Medical Devices

Abstract

The medical device includes a manipulation member, a hub, and an end effector. The manipulation member includes an actuating portion. The hub includes a channel that receives the actuating portion of the manipulation member. The actuating portion of the manipulation member moves within the channel. The end effector is movable between a closed configuration and an open configuration. Distal extension of the manipulation member transitions the end effector to the open configuration and proximal retraction of the manipulation member transitions the end effector to the closed configuration. The medical device is formed by an additive manufacturing process.

Description

[Technical Field]

[0001] Various aspects of the present disclosure relate generally to medical devices and methods for manipulating or treating tissue or other matter within the body. In particular, aspects of the present disclosure relate to medical devices and methods for making and / or using devices that include an end effector that is movable between an open configuration and a closed configuration. [Background technology]

[0002] Tissue samples or other materials are often examined to determine the presence of pathological diseases. Endoscopic biopsy forceps can be used with an endoscope to obtain samples from the human body for analysis. Often, samples must be obtained from deep within the body in locations that are difficult to access using standard forceps jaws (e.g., tissue from areas accessible only via tortuous bile duct pathways). Furthermore, the delivery device (e.g., endoscope) or sample site may limit the size of the forceps that can be used to access the tissue. In addition, because forceps (and other end effectors) often include multiple small, individual, separately manufactured parts or components that must be assembled through a complex process, manufacturing and / or assembling the forceps jaws can be a costly and / or time-intensive procedure. These concerns can increase the duration, cost, and risk of medical procedures. The devices and methods of the present disclosure may correct some of the deficiencies described above or address other aspects of the art. Summary of the Invention

[0003] Examples of the present disclosure relate, inter alia, to devices and methods for manufacturing or using end effectors for one or more medical procedures. Each of the examples disclosed herein may include one or more of the features described in connection with any of the other disclosed examples.

[0004] In one example, the medical device may include an operating member, a hub, and an end effector. The operating member may include an actuation portion. The hub may include a channel that receives the actuation portion of the operating member. The actuation portion of the operating member may be movable within the channel. The end effector may be movable between a closed configuration and an open configuration. Distal extension of the operating member may transition the end effector to the open configuration, and proximal retraction of the operating member may transition the end effector to the closed configuration. The medical device may be formed by an additive manufacturing process.

[0005] The medical device may include one or more of the following features: The end effector may include a first arm and a second arm, and each of the first arm and the second arm may include a control portion extending into the hub to interact with the actuation portion. The control portions of the first and second arms may each include an extension surface and a retracted surface offset from the extension surface. The hub may include a recess, and the control portion may include an extension within the recess to pivotally retain the control portion within the hub. The distal portion of the actuation portion may include two prongs offset from each other, and each prong may include an extension surface, a retracted surface, an angled surface, and an opening. The distal extension of the actuation portion may cause the extension surface of one prong to contact the extension surface of one of the first and second arms, transitioning one of the first and second arms to the open configuration. Proximal retraction of the actuation portion may cause a retracted surface of one of the prongs to contact a retracted surface of the other of the first and second arms and transition the other of the first and second arms to a closed configuration. The retracted surfaces of the first and second arms may be disposed within a plurality of openings in the plurality of prongs in the open configuration. The operating member may include a ring portion, and the hub may include an enlarged channel portion having proximal and distal stop surfaces configured to abut the ring portion to limit proximal and distal movement of the operating member.

[0006] The operating member may include a threaded coupling portion configured to couple the medical device to the drive element. The medical device may be formed of metal. The additive manufacturing process may include depositing successive layers of material on a build platform and selectively sintering portions of the layers to form the medical device. The selective sintering may be performed using a laser light source. The additive manufacturing process may include forming one or more support structures and separating the one or more support structures from the medical device using a wire electrical discharge machining process. The medical device may undergo one or more post-processing procedures after separation of the one or more support structures. The medical device may be approximately 1 cm in length.

[0007] In another aspect, a medical device may include an operating member, a hub, a first arm, and a second arm. The operating member may include an actuation portion. A distal portion of the actuation portion may include two prongs offset from one another, each prong including an extending surface and a retracting surface. The hub may include a channel that receives the actuation portion of the operating member, and the actuation portion of the operating member may move within the channel. The first arm and the second arm may be movable between a closed configuration and an open configuration. Each of the first arm and the second arm may include a control portion extending within the hub to interact with the actuation portion of the operating member. The control portions of the first and second arms may each include an extending surface and a retracting surface offset from the extending surface. Distal extension of the actuation portion may cause the extending surface of one of the prongs to contact the extending surface of one of the first and second arms, transitioning one of the first and second arms to the open configuration. Proximal retraction of the actuation portion may cause a retracted surface of one prong to contact a retracted surface of the other of the first and second arms and may transition the other of the first and second arms to a closed configuration.

[0008] The medical device may include one or more of the following features. Each of the two prongs may include an opening disposed proximal to the retracted surface, and the retracted surfaces of the first and second arms may be disposed within the openings in the prongs in the open configuration. The operating member may include a ring portion and a coupling portion configured to couple the medical device to the drive element. The hub may include an enlarged channel portion having proximal and distal stop surfaces configured to abut the ring portion to limit proximal and distal movement of the operating member. The medical device may be formed from a metallic material by an additive manufacturing process.

[0009] In yet another aspect, a method of operating a medical device may include delivering the medical device to a treatment site. The medical device may include an operating member, a hub, a first arm, and a second arm. The operating member may include an actuation portion. A distal portion of the actuation portion may include two prongs offset from one another, each prong may include an extending surface and a retracting surface. The hub may include a channel that receives the actuation portion of the operating member. The actuation portion of the operating member may move within the channel. The first arm and the second arm may be movable between a closed configuration and an open configuration. Each of the first arm and the second arm may include a control portion extending within the hub to interact with the actuation portion. The control portions of the first and second arms may each include an extending surface and a retracting surface offset from the extending surface. The method may also include transitioning the first arm and the second arm to the open configuration. Transitioning the first arm and the second arm to the open configuration may include extending the operating member distally such that an extended surface of one of the prongs contacts an extended surface of one of the first and second arms, transitioning one of the first and second arms to the open configuration. The method may further include transitioning the first arm and the second arm to the closed configuration. Transitioning the first arm and the second arm to the closed configuration may include retracting the operating member proximally such that a retracted surface of one of the prongs contacts a retracted surface of the other of the first and second arms, transitioning the other of the first and second arms to the closed configuration.

[0010] 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 present disclosure, as claimed. [Brief explanation of the drawings]

[0011] 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 disclosure. [Figure 1]1 shows a perspective view of an exemplary medical device according to aspects of the present disclosure. [Figure 2A] 2A-2D show side views of the medical device of FIG. 1 in different configurations, according to an embodiment of the present disclosure. [Figure 2B] 2A-2D show side views of the medical device of FIG. 1 in different configurations, according to an embodiment of the present disclosure. [Figure 3] 2A-2C show side views of the medical device of FIG. 1 at intermediate stages of manufacture, according to an embodiment of the present disclosure. [Figure 4A] 2A-2C show different views of the medical device of FIG. 1, in which a portion of the medical device is transparent, according to an embodiment of the present disclosure. [Figure 4B] 2A-2C show different views of the medical device of FIG. 1, in which a portion of the medical device is transparent, according to an embodiment of the present disclosure. [Figure 4C] 2A-2C show different views of the medical device of FIG. 1, in which a portion of the medical device is transparent, according to an embodiment of the present disclosure. [Figure 5A] 2A-2C show side views of a portion of the medical device of FIG. 1 at different stages of use, with a portion of the medical device remaining transparent, according to an embodiment of the present disclosure. [Figure 5B] 2A-2C show side views of a portion of the medical device of FIG. 1 at different stages of use, with a portion of the medical device remaining transparent, according to an embodiment of the present disclosure. [Figure 5C] 2A-2C show side views of a portion of the medical device of FIG. 1 at different stages of use, with a portion of the medical device remaining transparent, according to an embodiment of the present disclosure. [Figure 5D] 2A-2C show side views of a portion of the medical device of FIG. 1 at different stages of use, with a portion of the medical device remaining transparent, according to an embodiment of the present disclosure. DETAILED DESCRIPTION OF THE INVENTION

[0012] The terms "proximal" and "distal" are used herein to indicate the relative locations of components of the exemplary medical system and exemplary medical device. As used herein, "proximal" indicates a location relatively closer to the outside of the body or closer to the medical professional using the medical system or medical device. In contrast, "distal" indicates a location relatively farther away from the medical professional using the medical system or medical device or closer to the inside of the body. As used herein, the terms "comprises," "comprising," "having," "including," or other variations thereof, are intended to cover a non-exclusive inclusion, such that a system, device, or method comprising a list of elements does not include only those elements, but may include other elements not expressly listed or inherent thereto. Unless otherwise specified, the term "exemplary" is used in the sense of "example" rather than "ideal." As used herein, the terms "about," "substantially," and "approximately" indicate a range of values ​​within + / - 10% of the stated value.

[0013] Examples of the present disclosure include devices and methods for facilitating and / or improving the effectiveness, efficiency, and / or safety of medical procedures. Embodiments of the present disclosure may relate to devices and methods for performing various medical procedures and / or therapeutic portions of the large intestine (colon), small intestine, cecum, esophagus, stomach, any other portion of the gastrointestinal tract, kidneys or other portions of the urinary tract, heart, lungs, and / or any other suitable patient anatomical structure. Various embodiments described herein include single-use or disposable medical devices. Some aspects of the present disclosure may be used in performing endoscopy, arthroscopes, bronchoscopes, ureteroscopes, colonoscopes, or other types of procedures. For example, the disclosed aspects may be used with duodenoscopes, bronchoscopes, ureteroscopes, colonoscopes, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices. One or more elements discussed herein may be metal, plastic, or may include any combination of shape-memory metals (e.g., nitinol), shape-memory polymers, polymers, or biocompatible materials.

[0014] Reference will now be made in detail to the examples of the present disclosure described above and illustrated in the accompanying drawings. Wherever possible, the same reference numbers will be used throughout the drawings to refer to the same or like parts. It should be noted that one or more aspects of the medical devices discussed herein may be combined and / or used in conjunction with one or more aspects of the other medical devices discussed herein.

[0015] FIG. 1 shows a perspective view of an exemplary medical device 10 in an open configuration. The medical device 10 includes an end effector, e.g., forceps 12 at a distal end, an operating member 14 at a proximal end, and a hub 16 connecting the forceps 12 and the operating member 14. The forceps 12 includes a first arm 18A and a second arm 18B. The operating member 14 includes a connecting portion 20 and an actuation portion 22. Movement of the operating member 14 (e.g., distally or proximally along the longitudinal axis A of the medical device 10) transitions the arms 18A and 18B of the forceps 12 between a closed configuration ( FIG. 2A ) and an open configuration ( FIG. 2B ). In the examples discussed herein, the medical device 10 is formed by three-dimensional printing or an additive manufacturing process.

[0016] The arms 18A and 18B of the forceps 12 may include a plurality of teeth 24A and 24B, which are formed by a plurality of extensions and depressions (ridges and valleys) on the inner surface of each of the arms 18A and 18B. The arms 18A and 18B may also include toothless portions, for example, at the proximal and / or distal ends of each of the arms 18A and 18B. Additionally, the arms 18A and 18B each include a proximal control portion 26A and a proximal control portion 26B that extend into the hub 16. For example, the hub 16 includes a plurality of distal openings 28, through which the control portions 26A and 26B extend. As discussed below, the control portions 26A and 26B can interact with the actuation portion 22 to control the opening and closing of the arms 18A and 18B. In these embodiments, arms 18A and 18B are substantially identical, but may be mirror images. Additionally, although not shown, in some embodiments, one or more of arms 18A and 18B may include one or more drainage holes. The one or more drainage holes may extend through one or more of tines 24A and 24B, for example, from the inner surface of arms 18A and 18B to the outer surface of arms 18A and 18B. The one or more drainage holes may serve to allow fluids to drain or otherwise escape from forceps 12. In these embodiments, the one or more drainage holes may be formed during formation of medical device 10, for example, during a three-dimensional printing or additive manufacturing process.

[0017] The operating member 14 may be configured to couple a drive element (e.g., a drive wire) to the medical device 10. For example, as shown, the coupling portion 20 may include threads, for example, for coupling the drive element to the operating member 14. However, the disclosure is not so limited, and the coupling portion 20 may include openings for forming other or additional coupling mechanisms, for example, a press-fit or snap-fit ​​connection. Also, although not shown, the coupling portion 20 may be coupled to the drive element by soldering, welding, or the like. Furthermore, although not shown, a sheath or tube may be coupled to the hub 16 (e.g., coupled to a proximal portion of the hub 16). For example, the sheath may be coupled to the hub 16 by adhesive. In this embodiment, one or more portions of the outer surface of the hub 16 may include a lattice structure and / or a roughened surface, which may aid in adhering the sheath to the hub 16. In this manner, the drive element may be movable relative to the sheath (e.g., within the lumen of the sheath) via a proximal handle, for example, to control movement of the operating member 14 relative to the hub 16.

[0018] The actuating portion 22 may be substantially cylindrical and extend distally of the connecting portion 20. The actuating portion 22 may extend through a proximal opening (not shown) in the hub 16 and may be movable (proximally and / or distally) relative to the hub 16 to control the position of the arms 18A and 18B. For example, a distal portion of the actuating portion 22 may interact with the control portions 26A and 26B of the arms 18A and 18B to control the opening and / or closing of the arms 18A and 18B. Additionally, the actuating portion 22 may include one or more indicia 30, which may help a user visualize the position of the actuating portion 22 relative to the hub 16, for example, via a visualization device (e.g., a camera) positioned at the treatment site. The position of the indicia(s) 30 on the actuating portion 22 may indicate the configuration of the forceps 12, as shown in FIGS. 2A and 2B . In some embodiments, the indicia(s) 30 may be radiopaque and thus may be visualized external to the patient via x-ray or other visualization device.

[0019] As described above, the hub 16 encloses a portion of the forceps 12 and the operating member 14. The hub 16 includes a plurality of distal openings 28 for receiving the control portions 26A and 26B of the arms 18A and 18B. Additionally, although not shown, the hub 16 includes a proximal opening for receiving a portion of the actuation portion 22. The proximal opening and the plurality of distal openings 28 are connected within the hub 16 to form a channel 32 ( FIGS. 4A and 4B ) within the hub 16. One or more portions of the channel 32 may be generally cylindrical. The actuation portion 22 is movable within a portion of the channel 32, and the control portions 26A and 26B may be pivotally grasped or retained within a distal portion of the channel 32.

[0020] FIG. 2A shows the medical device 10 in a closed configuration, and FIG. 2B shows the medical device 10 in an open configuration. In FIG. 2A, the operating member 14, and thus the working portion 22, are in a proximally retracted position relative to the hub 16. Thus, the arms 18A and 18B of the forceps 12 are in a closed configuration; for example, the teeth 24A of the arm 18A are in contact with or close to the teeth 24B of the arm 18B. In FIG. 2B, the operating member 14, and thus the working portion 22, are in a distally extended position relative to the hub 16; for example, the majority of the working portion 22 extends into the hub 16. Thus, the arms 18A and 18B of the forceps 12 are in an open configuration; for example, the teeth 24A of the arm 18A are spaced apart from the teeth 24B of the arm 18B. Although not shown, the medical device 10 may include one or more springs or biasing elements (e.g., within the hub 16 or in the proximal handle (not shown)), which may bias the medical device 10 toward a closed configuration or an open configuration.

[0021] As shown in FIG. 3, the medical device 10 may be formed by a three-dimensional printing or additive manufacturing process. For example, multiple layers of material (e.g., about 5 microns to about 50 microns thick, e.g., about 25 microns thick) may be deposited on a build platform (not shown), and portions of the multiple layers may be selectively sintered to form the medical device 10. Portions of the multiple layers may be sintered using a laser light source. The multiple layers of material may be determined using a three-dimensional model (e.g., a 3D CAD model) of the medical device 10 and slicing software. In this embodiment, multiple layers of powder (e.g., metal powder) may be applied sequentially to the build platform, and portions of each layer may be melted (e.g., using a laser light source) to solidify the powder, optionally bonding portions of the layer to the layer below. The laser light source fires only on the build platform at one or more locations that define the part shape for each particular layer. Additionally, the laser light source does not fire to melt other portions of the layer that do not define the part shape, such as portions of the layer that form cavities within that layer. The portions of the layer that do not define the part shape remain as powder. The powder may be removed from the part during post-processing.

[0022] Additionally, one or more sacrificial or support structures 34 may be constructed to help support portions of the medical device 10 during the fabrication process. For example, as shown in FIG. 3 , the medical device 10, including one or more sacrificial or support structures 34, may be built vertically on a build platform. The location and / or size of the one or more support structures 34 may be determined and implemented by slicing software. For example, the support structures 34 may be formed to help support the arms 18A and 18B of the forceps 12. The support structures 34 may then be separated from the forceps 12 after the fabrication process, for example, by a wire electrical discharge machining process. Although not shown, additional support structures may support the operating member 14, the connecting portion 20, and the actuating portion 22, such as the hub 16, during the fabrication process and may be removed after fabrication. Separation of the one or more support structures 34 may also help separate multiple components (e.g., the arms 18A and 18B from the hub 16) so that the multiple components are movable relative to one another.

[0023] The medical device 10 may be formed from a biocompatible metallic material (e.g., stainless steel, titanium, etc.). In this embodiment, multiple layers of metallic powder may be deposited on a build platform and selectively sintered to form the multiple layers of the medical device 10. The one or more support structures 34 may be formed from the same metallic material or from a different material. Additionally, one or more surface treatment or post-processing techniques or procedures (e.g., electropolishing, chemical etching, etc.) may be performed on the medical device 10, for example, to smooth the surface of the medical device 10 after separation from the support structure(s) 34. Thus, once the medical device 10 is formed, after the support structures 34 are removed from the medical device 10 and any post-processing procedures are performed, the medical device 10 may be ready for use and require no additional assembly, except for connection to a drive element, sheath, handle, etc. Thus, unlike typical end effectors that have multiple small, individual, separately manufactured parts that require assembly, medical device 10 does not require assembly other than attaching medical device 10 to multiple control elements (e.g., drive wires and sheaths).

[0024] Furthermore, based on the medical device 10 formed by three-dimensional printing or additive manufacturing processes, the medical device 10 can be smaller than typical medical devices or end effectors, including forceps. For example, as described above, portions of the medical device 10 need not be connected or otherwise coupled to other portions of the medical device 10. In this embodiment, the medical device 10 may be about 7 cm or less in length, e.g., about 5 cm, about 3 cm, about 2 cm, or about 1 cm (e.g., about 11 mm). The medical device 10 may be about 10 mm or less in width, e.g., about 5 mm, about 2-3 mm, or about 2.4 mm. Additionally, in the open configuration, the arms 18A and 18B of the forceps 12 may form an opening (e.g., between the distal end of arm 18A and the distal end of arm 18B) that is about 6 mm to 12 mm wide, e.g., about 9 mm wide.

[0025] 4A-4C are different views of the medical device 10, with the hub 16 shown as transparent. FIG. 4A is a side view of the medical device 10, showing arms 18A and 18B of the forceps 12. FIG. 4B is a top view of the medical device 10, for example, rotated approximately 90 degrees along its longitudinal axis A (FIG. 1), showing arm 18A of the forceps 12 when arm 18B is interrupted by arm 18A. FIG. 4C is an enlarged view of a portion of FIG. 4B.

[0026] As shown in FIGS. 4A-4C, arms 18A and 18B each include a control portion 26A and a control portion 26B disposed within hub 16. Control portions 26A and 26B are offset from the center of medical device 10 in a direction perpendicular to longitudinal axis A (e.g., offset horizontally and / or into the page in FIGS. 4A and 5A-5D). For example, as shown in FIGS. 4A and 5A-5D, control portion 26B is above and to the left of a portion of control portion 26A. Control portions 26A and 26B are pivotable (via action from actuation portion 22) to transition arms 18A and 18B between closed and open configurations. As described above, actuation portion 22 extends within hub 16. Actuation portion 22 includes a distal end 40 configured to contact and move control portions 26A and 26B to transition arms 18A and 18B between the closed and open configurations. Distal end 40 and control portions 26A and 26B interact at a distal portion 42 of channel 32, as shown in FIG. 4C.

[0027] Additionally, actuation portion 22 includes a radial extension or ring portion 44, and hub 16 includes an enlarged channel 46 having proximal and distal stop surfaces 46A, 46B. Ring portion 44 is disposed within enlarged channel 46, and proximal and distal stop surfaces 46A, 46B limit proximal and distal movement of actuation portion 22, and thus operating member 14, relative to hub 16.

[0028] As shown in FIGS. 4B and 4C, the medical device 10 may also include an enclosed conical hinge design. For example, the hub 16 may include two recesses 48A and 48B, each of which has a generally conical shape and extends radially outward. The control portions 26A and 26B of the arms 18A and 18B may include extensions 50A and 50B, which may also have a generally conical shape. For example, FIG. 4B shows the control portion 26A extending through the distal opening 28A. The extensions 50A and 50B may be received and movable within the recesses 48A and 48B such that the control portions 26A and 26B of the arms 18A and 18B are retained within the hub 16 and such that the arms 18A and 18B can pivot between a closed configuration and an open configuration.

[0029] Additionally, distal end 40 of actuation portion 22 includes two prongs 52A and 52B that are movable with actuation portion 22 and interact with control portions 26A and 26B to transition arms 18A and 18B between closed and open configurations.

[0030] 5A-5D show further details of the interaction of arms 18A and 18B with actuation portion 22 within hub 16. FIG. 5A illustrates the transition from the closed configuration to the open configuration. For example, medical device 10 may be delivered to a treatment site, and actuation portion 22 and prongs 52A and 52B are extended distally (as indicated by the vertical arrows), which pivots control portions 26A and 26B, separating and opening arms 18A and 18B. Actuation portion 22 may be extended distally through the action of a drive element coupled to link portion 20. In this embodiment, control portions 26A and 26B include extension surfaces 54A and 54B and retracted surfaces 56A and 56B, respectively. The extending surface 54A may be offset from the receding surface 56A in a direction perpendicular to the longitudinal axis A (e.g., offset laterally, offset out of the page in FIGS. 5A-5D). In this embodiment, the extending surface 54A may be above the receding surface 56A, as shown in FIGS. 5A-5D. Similarly, the extending surface 54B may be offset from the receding surface 56B in a direction perpendicular to the longitudinal axis A (e.g., offset laterally, offset out of the page in FIGS. 5A-5D). In this embodiment, the extending surface 54B may be below the receding surface 56B, as shown in FIGS. 5A-5D.

[0031] Prongs 52A and 52B are offset from one another in a direction perpendicular to longitudinal axis A (e.g., laterally offset, offset out of the page in FIGS. 5A-5D). In this embodiment, as shown in the side views of FIGS. 5A-5D, prong 52B is above prong 52A. Prongs 52A and 52B each include an extending surface 58, a recessed surface 60, and an inclined surface 62. The figures show only the extending surface 58, recessed surface 60, and inclined surface 62 of prong 52B. The extending surface 58 of prong 52B may be perpendicular to longitudinal axis A (FIG. 1), and the extending surface 58 of prong 52B may contact and overlap the extending surface 54B of control portion 26B to pivot arm 18B toward the open configuration. Although not shown, the extension surface of prong 52A may also be perpendicular to longitudinal axis A and may contact and overlap the extension surface of control portion 26A to pivot arm 18A toward the open configuration. Like arms 18A and 18B, prong 52B may be a mirror image of prong 52A or may have an inverted configuration.

[0032] 5B shows the medical device 10 in an open configuration. As shown, the ring portion 44 may abut or be proximate to the distal stop surface 46B, and the arms 18A and 18B are separated. Furthermore, the angled surface 62 extending proximally from the extension surface 58 at an angle may contact the extension surface 54B of the control portion 26B of the arm 18B along all or a corresponding portion of the extension surface 54B. Although not shown, the extension surface of the prong 52A may contact the extension surface of the control portion 26A of the arm 18A. Furthermore, the recessed surface 56A of the arm 18A may be disposed within the opening 64 of the prong 52B (e.g., proximal to the recessed surface 60). As shown, the recessed surface 60 is disposed proximal to the extension surface 58 and extends at an angle configured to correspond to (e.g., mate with and / or abut) the recessed surface 56A of the control portion 26A. Additionally, although not shown, the recessed surface 56B of the arm 18B may be disposed within the opening in the prong 52A.

[0033] 5C illustrates a transition from the open configuration to the closed configuration, e.g., to capture or otherwise treat tissue or other material at a treatment site. For example, actuation portion 22 and prongs 52A and 52B are retracted proximally (as indicated by the vertical arrows), which pivots control portions 26A and 26B to close arms 18A and 18B. Actuation portion 22 can be retracted proximally through the action of a drive element coupled to linking portion 20. In this embodiment, retracted surface 60 of prong 52B contacts retracted surface 56A of control portion 26A, pivoting arm 18A toward the closed configuration. Similarly, although not shown, the retracted surface of prong 52A contacts the retracted surface of control portion 26B, pivoting arm 18B toward the closed configuration.

[0034] 5D shows the closed configuration. In this embodiment, actuation portion 22 and prongs 52A and 52B are proximally retracted. Furthermore, in the closed configuration, extension surface 58 of prong 52B may abut or be adjacent to extension surface 54B of control portion 26B. Extension surface 54A of prong 52A may abut or be adjacent to extension surface 54A of control portion 26A.

[0035] 5A-5D may be performed as many times as necessary during a medical procedure, for example, to capture or otherwise manipulate tissue or other material. In this manner, extension of one prong may transition a first arm of forceps 12 from a closed configuration to an open configuration, and retraction of one prong may transition a second arm of forceps 12 from an open configuration to a closed configuration.

[0036] Although the end effector is described as a forceps 12, the present disclosure is not so limited. For example, various aspects of the present disclosure may be used to form and / or use other end effectors, including pivoting, expanding, translating, and / or openable elements. For example, the end effector may be a grasper, scissors, clip, stapler, needle, knife, etc.

[0037] Various aspects discussed herein may help reduce the duration, cost, and / or risk of medical procedures. For example, three-dimensional printing and / or additive manufacturing may help reduce the number of components required to form a forceps or other medical device. Reducing the number of components allows for more efficient assembly, reduced material or product construction costs, reduced part count and / or part number, reduced likelihood of breakage and / or malfunction, relaxed size and / or shape tolerances (e.g., no tolerance stackup due to assembled components), etc. Additionally, multiple medical devices 10 may be manufactured on the same build platform, reducing manufacturing and assembly time, costs, etc.

[0038] Additionally, three-dimensional printing or additive manufacturing allows the medical device 10 to be smaller in size and / or have a more complex design than traditionally assembled medical devices. As a result, the medical device 10 may be maneuverable and / or deliverable to or through small and / or convoluted locations or lumens within a patient. The medical device 10 may be manipulated via an actuation element, where distal movement of the actuation element transitions the medical device 10 to an open configuration ( FIG. 2B ) and proximal movement of the actuation element transitions the medical device 10 to a closed configuration ( FIG. 2A ). The medical device 10 may also be capable of targeting smaller locations (e.g., smaller portions of tissue) than, for example, larger, conventional medical devices.

[0039] Thus, various aspects discussed herein may help improve the effectiveness of treatment and / or recovery from a procedure, e.g., a procedure for treating a treatment site. Various aspects discussed herein may help reduce and / or minimize the duration of a procedure and / or help reduce the risk of inadvertent contact with tissue or other materials during delivery, repositioning, or use of a medical device in a procedure.

[0040] While the principles of the present disclosure are described herein with reference to illustrative embodiments for various applications, it should be understood that the disclosure is not limited thereto. Those skilled in the art and with access to the teachings provided herein will recognize additional modifications, applications, embodiments, and equivalent substitutions that are all within the scope of the embodiments described herein. Accordingly, the present disclosure should not be deemed limited by the foregoing description.

Claims

1. An operating member including an actuating portion; a hub including a channel for receiving the actuation portion of the control member, the actuation portion of the control member moving into the channel; an end effector movable between a closed configuration and an open configuration, distal extension of the actuation member transitions the end effector to an open configuration; proximal extension of the actuation member transitions the end effector to a closed configuration; The medical device is formed by an additive manufacturing process. The medical device.

2. 2. The medical device of claim 1, wherein the end effector includes a first arm and a second arm, each of the first arm and the second arm including a control portion extending within the hub to interact with the actuation portion.

3. 3. The medical device of claim 2, wherein the control portions of the first arm and the second arm each include an extending surface and a recessed surface offset from the extending surface.

4. The medical device of claim 2 , wherein the hub includes a plurality of recesses and the control portion includes a plurality of extensions within the plurality of recesses to pivotally retain the control portion within the hub.

5. The medical device of claim 3 , wherein the distal portion of the working portion includes two prongs offset from one another, each prong including an extension surface, a recessed surface, an inclined surface, and an opening.

6. 6. The medical device of claim 5, wherein distal extension of the actuating portion causes the extended surface of one prong to contact the extended surface of one of the first and second arms, transitioning one of the first and second arms to the open configuration, and proximal retraction of the actuating portion causes the retracted surface of the one prong to contact the retracted surface of the other of the first and second arms, transitioning the other of the first and second arms to the closed configuration.

7. 7. The medical device of claim 5 or 6, wherein the recessed surfaces of the first and second arms are disposed within a plurality of openings in a plurality of prongs in the open configuration.

8. 7. The medical device of claim 1, wherein the operating member includes a ring portion and the hub includes an enlarged channel portion having proximal and distal stop surfaces configured to abut the ring portion to limit proximal and distal movement of the operating member.

9. The medical device of any one of claims 1 to 6, wherein the operating member comprises a threaded connection portion configured to connect the medical device to a drive element.

10. The medical device of any one of claims 1 to 6, wherein the medical device is formed of a metal.

11. 7. The medical device of any one of claims 1 to 6, wherein the additive manufacturing process comprises depositing successive layers of material on a build platform and selectively sintering portions of a plurality of layers to form the medical device.

12. 12. The medical device of claim 11, wherein the selective sintering is performed using a laser light source.

13. 7. The medical device of any one of claims 1-6, wherein the additive manufacturing process comprises forming one or more support structures and separating the one or more support structures from the medical device using a wire electrical discharge machining process.

14. The medical device of claim 13 , wherein the medical device is subjected to one or more post-processing procedures after separation of the one or more support structures.

15. The medical device of any one of claims 1 to 6, wherein the medical device is about 1 cm in length.

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