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 generally relate to medical devices and methods for manipulating or treating tissues or other substances within the body. In particular, aspects of the present disclosure relate to medical devices and methods for manufacturing and / or using a device that includes an end effector that is movable between an open configuration and a closed configuration.

Background Art

[0002] To determine the presence of a pathological disease, tissue samples or other substances are often examined. Endoscopic biopsy forceps can be used with an endoscope to obtain a sample from the human body for analysis. In many cases, samples must be obtained from deep within the body at locations that are difficult to access using standard forceps jaws (e.g., tissue from an area accessible only via a tortuous bile duct path). Additionally, the delivery device (e.g., an endoscope) or the sample site can limit the size of the forceps that can be used to access the tissue. In addition, forceps (and other end effectors) often include multiple small, individually manufactured parts or components that need to be assembled by a complex process, so the manufacture and / or assembly of the forceps jaws can be a costly and / or time-consuming procedure. These concerns can increase the duration, cost, and risk of a medical procedure. 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 in particular to devices and methods for manufacturing or using an end effector for one or more medical procedures. Each of the examples disclosed herein may include one or more of the features described in relation to any of the other disclosed examples.

[0004] In one embodiment, the medical device may include an operating member, a hub, and an end effector. The operating member may include an actuation part. The hub may include a channel for receiving the actuation part of the operating member. The actuation part of the operating member can move within the channel. The end effector may be movable between a closed and an open configuration. Distal extension of the operating member may cause the end effector to transition to an open configuration, and proximal retraction of the operating member may cause the end effector to transition to a 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, each of which may include a control portion extending within a hub to interact with the actuating part. The control portions of the first and second arms may each include an extending surface and a receding surface offset from the extending surface. The hub may include a recess, and the control portion may include an extending portion within the recess to pivotably hold the control portion within the hub. The distal portion of the actuating part may include two prongs offset from each other, each prong may include an extending surface, a receding surface, an inclined surface, and an opening. The distal extension of the actuating part may cause the extending surface of one prong to contact the extending surface of one of the first and second arms, thereby transitioning one of the first and second arms into an open configuration. The proximal retraction of the operating part may cause the retracted surface of one prong to contact the other retracted surface of the first and second arms, or cause the other of the first and second arms to transition to a closed position. The retracted surfaces of the first and second arms may be located within multiple openings in the multiple prongs in the open position. The operating member may include a ring portion, and the hub may include an expanding channel portion having proximal and distal stop surfaces configured to abut against the ring portion to restrict the proximal and distal movement of the operating member.

[0006] The operating member may include a threaded connector configured to connect the medical device to a drive element. The medical device may be formed of metal. The additive manufacturing process may include depositing continuous layers of material on a construction platform and selectively sintering portions of multiple layers to form the medical device. Selective sintering may be performed using a laser light source. The additive manufacturing process may include forming one or more support structures and separating 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 steps after the separation of one or more support structures. The medical device may be about 1 cm in length.

[0007] In another embodiment, the medical device may include an operating member, a hub, a first arm, and a second arm. The operating member may include an actuation part. The distal portion of the actuation part may include two prongs offset from each other, each prong including an extending surface and a retracted surface. The hub may include a channel for receiving the actuation part of the operating member, and the actuation part of the operating member may move within the channel. The first and second arms may be movable between a closed and an open configuration. Each of the first and second arms may include a control portion extending into the hub to interact with the actuation part of the operating member. The control portions of the first and second arms may each include an extending surface and a retracted surface offset from the extending surface. The distal extension of the actuation part may cause the extending surface of one prong to contact the extending surface of one of the first and second arms, thereby transitioning one of the first and second arms to an open configuration. The proximal retraction of the operating part may cause the retracted surface of one prong to contact the other retracted surface of the first and second arms, or it may cause the other of the first and second arms to transition to a closed position.

[0008] The medical device may include one or more of the following features: Each of the two prongs may include an opening located proximal to the retracted surface, and the retracted surfaces of the first and second arms may be located within multiple openings in the multiple prongs in an open configuration. The operating member may include a ring portion and a connecting portion configured to connect the medical device to a drive element. The hub may include an expanding channel portion having proximal and distal resting surfaces configured to abut against the ring portion to restrict the 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 embodiment, a method for 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 part. The distal portion of the actuation part may include two prongs offset from each other, each prong including an extending surface and a retracted surface. The hub may include a channel for receiving the actuation part of the operating member. The actuation part of the operating member can move within the channel. The first arm and the second arm may be movable between a closed 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 part. The control portions of the first and second arms may each include an extending surface and a retracted 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 and second arms to the open position may include extending the operating member distally such that the extended surface of one prong contacts the extended surface of one of the first and second arms, thereby transitioning one of the first and second arms to the open position. The method may further include transitioning the first and second arms to the closed position. Transitioning the first and second arms to the closed position may include retracting the operating member proximally such that the retracted surface of one prong contacts the retracted surface of the other of the first and second arms, thereby transitioning the other of the first and second arms to the closed position.

[0010] Please understand that both the general description above and the detailed description below are illustrative and explanatory only and do not limit the claimed disclosure. [Brief explanation of the drawing]

[0011] The accompanying drawings incorporated herein and constituting part of herein illustrate exemplary embodiments of this disclosure and serve to illustrate the principles of this disclosure together with the description. [Figure 1]An exemplary perspective view of a medical device according to the embodiments of this disclosure is shown. [Figure 2A] Figure 1 shows a side view of the medical device in a different configuration according to the aspects of this disclosure. [Figure 2B] Figure 1 shows a side view of the medical device in a different configuration according to the aspects of this disclosure. [Figure 3] Figure 1 shows a side view of the medical device in an intermediate stage of manufacturing, according to an aspect of this disclosure. [Figure 4A] Figure 1 shows a different diagram of the medical device in which a portion of the medical device is transparent, according to the aspects of this disclosure. [Figure 4B] Figure 1 shows a different diagram of the medical device in which a portion of the medical device is transparent, according to the aspects of this disclosure. [Figure 4C] Figure 1 shows a different diagram of the medical device in which a portion of the medical device is transparent, according to the aspects of this disclosure. [Figure 5A] Figure 1 shows a side view of a portion of the medical device at different stages of use, in which a portion of the medical device is transparent, according to the aspects of this disclosure. [Figure 5B] Figure 1 shows a side view of a portion of the medical device at different stages of use, in which a portion of the medical device is transparent, according to the aspects of this disclosure. [Figure 5C] Figure 1 shows a side view of a portion of the medical device at different stages of use, in which a portion of the medical device is transparent, according to the aspects of this disclosure. [Figure 5D] Figure 1 shows a side view of a portion of the medical device at different stages of use, in which a portion of the medical device is transparent, according to the aspects of this disclosure. [Modes for carrying out the invention]

[0012] The terms “proximal” and “distal” are used herein to indicate the relative location of components of exemplary medical systems and exemplary medical devices. Where used herein, “proximal” refers to a location relatively close to the outside of the body, or closer to the healthcare professional using the medical system or device. In contrast, “distal” refers to a location relatively far from the healthcare professional using the medical system or device, or closer to the inside of the body. Where used herein, the terms “comprises,” “comprising,” “having,” “including,” or other variations thereof are intended to be non-exclusive inclusions, such that a system, device, or method comprising a list of elements may include other elements not expressly enumerated or inherent to them, rather than including only those elements. Unless otherwise specified, the term “exemplary” is used in the sense of “example” rather than “ideal.” Where used herein, the terms “about,” “substantially,” and “approximately” indicate a range of values ​​within + / - 10% of the stated value.

[0013] Examples of the disclosure include devices and methods for promoting and / or improving the effectiveness, efficiency, and / or safety of medical procedures. Embodiments of the disclosure may relate to devices and methods for performing various medical procedures and / or treatment parts of the large intestine (colon), small intestine, cecum, esophagus, stomach, any other part of the gastrointestinal tract, kidney or other part of the urinary tract, heart, lungs, and / or any other appropriate patient anatomical structure. Various embodiments described herein include single-use, i.e., disposable medical devices. Some embodiments of the disclosure may be used when performing endoscopy, arthroscopy, bronchoscopy, ureteroscopy, colonoscopy, or other types of procedures. For example, the disclosed embodiments may be used with duodenoscopy, bronchoscopy, ureteroscopy, colonoscopy, catheters, diagnostic or therapeutic tools or devices, or other types of medical devices. One or more elements discussed herein may be metals, plastics, or any combination of shape memory metals (e.g., nitinol), shape memory polymers, polymers, or biocompatible materials.

[0014] Hereinafter, we refer in detail to the examples of this disclosure described above and shown in the accompanying drawings. Wherever possible, the same reference numerals are used throughout the drawings to indicate identical or similar parts. It should be noted that one or more embodiments of the medical devices discussed herein may be combined with and / or used together with one or more embodiments of other medical devices discussed herein.

[0015] Figure 1 shows a perspective view of an exemplary medical device 10 in an open configuration. The medical device 10 includes an end effector, for example, a forceps 12 at the distal end, an operating member 14 at the 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 operating portion 22. Movement of the operating member 14 (for example, distally or proximal along the longitudinal axis A of the medical device 10) causes the arms 18A and 18B of the forceps 12 to transition between a closed configuration (Figure 2A) and an open configuration (Figure 2B). In the examples discussed herein, the medical device 10 is formed by a three-dimensional printing or 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 recesses (peaks 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. Furthermore, the arms 18A and 18B each include proximal control portions 26A and 26B extending into the hub 16. For example, the hub 16 includes a plurality of distal openings 28, and the control portions 26A and 26B extend through each of the distal openings 28. As will be 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. Furthermore, although not shown, in some embodiments, one or more of arms 18A and 18B may include one or more drainage holes. One or more drainage holes may extend, for example, from the inner surfaces of arms 18A and 18B to the outer surfaces of arms 18A and 18B through one or more of the teeth 24A and 24B. One or more drainage holes may help to allow fluid to drain or otherwise flow out of the forceps 12. In these embodiments, one or more drainage holes may be formed during the formation of the medical device 10, for example, during a three-dimensional printing or additive manufacturing process.

[0017] The operating member 14 may be configured to connect a drive element (e.g., a drive wire) to the medical device 10. For example, as shown, the connecting portion 20 may include, for example, threads for connecting the drive element to the operating member 14. However, the disclosure is not limited thereto, and the connecting portion 20 may include other or additional connecting mechanisms, such as openings for forming press-fit or snap-fit ​​connections. Also, although not shown, the connecting portion 20 may be connected to the drive element by soldering, welding, or the like. Furthermore, although not shown, a sheath or tube may be connected to the hub 16 (e.g., to the proximal portion of the hub 16). For example, the sheath may be connected to the hub 16 by adhesive. In this embodiment, one or more portions of the outer surface of the hub 16 may include a grid structure and / or rough surface that can help in the adhesion of the sheath to the hub 16. Thus, the drive element may be movable relative to the sheath (e.g., within the lumen of the sheath) via a proximal handle to control, for example, the movement of the operating member 14 relative to the hub 16.

[0018] The actuation part 22 may be substantially cylindrical and extend distally to the connecting part 20. The actuation part 22 may also extend through a proximal opening (not shown) in the hub 16 and may be movable (proximal and / or distal) relative to the hub 16 to control the positions of arms 18A and 18B. For example, the distal portion of the actuation part 22 may interact with control parts 26A and 26B of arms 18A and 18B to control the opening and / or closing of arms 18A and 18B. Furthermore, the actuation part 22 may include one or more indicators 30, which may help the user visualize the position of the actuation part 22 relative to the hub 16, for example, via a visualization device (e.g., a camera) placed at the treatment site. The position of the indicator(s) 30 on the actuation part 22 may indicate the configuration of the forceps 12, as shown in Figures 2A and 2B. In some embodiments, the display(s) 30 may be radiopaque and, consequently, may be visualized outside the patient via X-rays or other visualization devices.

[0019] As described above, the hub 16 surrounds 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. Further, although not shown, the hub 16 includes a proximal opening for receiving a portion of the actuating portion 22. The proximal opening and the plurality of distal openings 28 are connected within the hub 16 to form a channel 32 (FIGS. A and 4B) within the hub 16. One or more portions of the channel 32 may be substantially cylindrical. The actuating portion 22 is movable within a portion of the channel 32, and the control portions 26A and 26B may be pivotally gripped or held within the 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 actuating portion 22, is in a position retracted proximally with respect to the hub 16. Accordingly, the arms 18A and 18B of the forceps 12 are in a closed configuration, e.g., the teeth 24A of the arm 18A are in contact with or proximate to the teeth 24B of the arm 18B. In FIG. 2B, the operating member 14, and thus the actuating portion 22, is in a position extending distally with respect to the hub 16, e.g., a majority of the actuating portion 22 extends within the hub 16. Accordingly, the arms 18A and 18B of the forceps 12 are in an open configuration, e.g., 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, i.e., biasing elements (e.g., within the hub 16 or a proximal handle (not shown)), which may bias the medical device 10 toward the closed configuration or the 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, a plurality of layers of material (e.g., layers having a thickness of from about 5 microns to about 50 microns, e.g., a layer having a thickness of about 25 microns) may be deposited on a build platform (not shown), and a portion of the plurality of layers may be selectively sintered to form the medical device 10. A portion of the plurality of layers may be sintered using a laser light source. The plurality of 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 manner, a plurality of layers of powder (e.g., metal powder) may be continuously applied to the build platform, and a portion of each layer may be melted (e.g., using a laser light source) to solidify the powder, and optionally, a portion of the layer may be adhered to the underlying layer. The laser light source emits only on the build platform at one or more positions that define the part shape for each particular layer. Further, the laser light source does not emit to melt other portions (if any) of the layer that do not define the part shape, e.g., a portion (if any) of the layer that forms a cavity within the layer. A portion (if any) of the layer that does not define the part shape remains as powder. The powder may be removed from the part during post-processing.

[0022] Furthermore, one or more sacrificial structures, or support structures 34, may be constructed to help support a portion of the medical device 10 during the forming process. For example, as shown in Figure 3, the medical device 10 including one or more sacrificial structures, or support structures 34, may be constructed vertically on a construction platform. The position 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 arms 18A and 18B of a forceps 12. The support structures 34 may then be separated from the forceps 12 after the forming process, for example, by a wire electrical discharge machining process. Although not shown, additional support structures may support the operating member 14, connecting parts 20 such as the hub 16 and working parts 22 during the forming process and may be removed after forming. The separation of one or more support structures 34 may also help separate multiple components (e.g., arms 18A and 18B from the hub 16) so that multiple components are movable relative to each other.

[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 metal powder can be deposited on a construction platform and selectively sintered to form multiple layers of the medical device 10. One or more support structures 34 may be formed from the same metallic material or from different materials. Furthermore, one or more surface treatment or post-treatment techniques or procedures (e.g., electropolishing, chemical etching, etc.) may be performed on the medical device 10 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 structure(s) 34 are removed from the medical device 10 and any post-treatment procedures are performed, the medical device 10 is ready for use, except for connections to drive elements, sheaths, handles, etc., and may not require additional assembly. Therefore, unlike typical end effectors which have multiple small, separate, and individually manufactured parts that require assembly, the medical device 10 requires no assembly other than attaching the 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 may be smaller than a typical medical device or end effector including forceps. For example, as described above, a portion of the medical device 10 does not need to be connected to or linked to another portion of the medical device 10. In this embodiment, the medical device 10 may be about 7 cm or less in length, for example, about 5 cm, about 3 cm, about 2 cm, or about 1 cm (for example, about 11 mm). The medical device 10 may be about 10 mm or less in width, for example, about 5 mm, about 2-3 mm, or about 2.4 mm. In addition, in the open configuration, the arms 18A and 18B of the forceps 12 may form an opening (for example, between the distal end of arm 18A and the distal end of arm 18B) that is about 6 mm to 12 mm in width, for example, about 9 mm in width.

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

[0026] As shown in Figures 4A-4C, arms 18A and 18B each include control sections 26A and 26B located within the hub 16. Control sections 26A and 26B are offset from the center of the medical device 10 in a direction perpendicular to the longitudinal axis A (for example, offset horizontally and / or within the page in Figures 4A and 5A-5D). For example, as shown in Figures 4A and 5A-5D, control section 26B is located above and to the left of a portion of control section 26A. Control sections 26A and 26B are pivotable (via action from the actuation section 22) to transition arms 18A and 18B between a closed and an open configuration. As described above, the actuation section 22 extends within the hub 16. The operating part 22 includes a distal end 40 configured to contact and move the control parts 26A and 26B to transition the arms 18A and 18B between a closed state and an open state. The distal end 40 and the control parts 26A and 26B interact in the distal portion 42 of the channel 32, as shown in Figure 4C.

[0027] Furthermore, the actuating portion 22 includes a radially extending portion, i.e., a ring portion 44, and the hub 16 includes an expanding channel 46 having a proximal stopping surface 46A and a distal stopping surface 46B. The ring portion 44 is positioned within the expanding channel 46, and the proximal stopping surface 46A and the distal stopping surface 46B restrict the proximal and distal movement of the actuating portion 22, and consequently the operating member 14, relative to the hub 16.

[0028] As shown in Figures 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 substantially conical in shape and extending radially outward. The control portions 26A and 26B of the arms 18A and 18B may include extending portions 50A and 50B, which may also be substantially conical in shape. For example, Figure 4B shows a control portion 26A extending through a distal opening 28A. The extending portions 50A and 50B may be receptacle-movable within the recesses 48A and 48B so that the control portions 26A and 26B of the arms 18A and 18B are held within the hub 16, and so that the arms 18A and 18B can pivot between a closed and an open configuration.

[0029] Furthermore, the distal end 40 of the actuation part 22 includes two prongs 52A and prongs 52B. Prongs 52A and prongs 52B are movable with the actuation part 22 and interact with control parts 26A and 26B to transition arms 18A and 18B between a closed state and an open state.

[0030] Figures 5A-5D show further details of the interaction between arms 18A and 18B and the actuation part 22 within the hub 16. Figure 5A shows the transition from a closed state to an open state. For example, the medical device 10 may be delivered to a treatment site, and the actuation part 22 and prongs 52A and 52B extend distally (as indicated by vertical arrows), which pivot the control part 26A and 26B, separating and opening arms 18A and 18B. The actuation part 22 may extend distally via the action of a drive element connected to the coupling part 20. In this embodiment, the control part 26A and 26B each include extending surfaces 54A and 54B and retracted surfaces 56A and 56B. The extending surface 54A may be offset from the receding surface 56A in a direction perpendicular to the longitudinal axis A (for example, offset laterally, so as to be offset in the direction away from the page in Figures 5A-5D). In this embodiment, as shown in Figures 5A-5D, the extending surface 54A may be above the receding surface 56A. Similarly, the extending surface 54B may be offset from the receding surface 56B in a direction perpendicular to the longitudinal axis A (for example, offset laterally, so as to be offset in the direction away from the page in Figures 5A-5D). In this embodiment, as shown in Figures 5A-5D, the extending surface 54B may be below the receding surface 56B.

[0031] The prongs 52A and 52B are offset from each other in a direction perpendicular to the longitudinal axis A (for example, offset laterally and offset off-page in Figures 5A-5D). In this embodiment, as shown in the side views of Figures 5A-5D, the prong 52B is above the prong 52A. The prongs 52A and 52B each include an extending surface 58, a receding surface 60, and an inclined surface 62. The figure shows only the extending surface 58, receding surface 60, and inclined surface 62 of the prong 52B. The extending surface 58 of the prong 52B may be perpendicular to the longitudinal axis A (Figure 1), and the extending surface 58 of the prong 52B may contact and overlap the extending surface 54B of the control section 26B so as to pivot the arm 18B toward the open position. Although not shown, the extending surface of the prong 52A may also be perpendicular to the longitudinal axis A, and may contact and overlap the extending surface of the control portion 26A so as to pivot the arm 18A toward the open position. Similar to arms 18A and 18B, the prong 52B may be a mirror image of the prong 52A, or may have an inverse arrangement.

[0032] Figure 5B shows the medical device 10 in an open configuration. As shown, the ring portion 44 may abut against or be close to the distal resting surface 46B, and the arms 18A and 18B are separated. Furthermore, the inclined surface 62, which extends proximal to the extending surface 58 at a certain angle, may contact the extending surface 54B of the control portion 26B of the arm 18B along the entirety or a corresponding portion of the extending surface 54B. Although not shown, the extending surface of the prong 52A may be in contact with the extending surface of the control portion 26A of the arm 18A. Furthermore, the receding surface 56A of the arm 18A may be located within the opening 64 of the prong 52B (e.g., proximal to the receding surface 60). As shown, the receding surface 60 is located proximal to the extending surface 58 and extends at an angle configured to correspond to (e.g., coincide with and / or abut against) the receding surface 56A of the control portion 26A. Furthermore, although not shown, the retracted surface 56B of the arm 18B may be positioned within the opening of the prong 52A.

[0033] Figure 5C illustrates a transition from an open to a closed configuration, for example, to capture or treat tissue or other material at a treatment site. For example, the working part 22 and prongs 52A and 52B are retracted proximally (as indicated by the vertical arrows), which pivots the control parts 26A and 26B to close arms 18A and 18B. The working part 22 can be retracted proximally via the action of a drive element connected to the connecting part 20. In this configuration, the retracted surface 60 of prong 52B contacts the retracted surface 56A of control part 26A, pivoting arm 18A toward the closed configuration. Similarly, although not shown, the retracted surface of prong 52A contacts the retracted surface of control part 26B, pivoting arm 18B toward the closed configuration.

[0034] Figure 5D shows the closed configuration. In this configuration, the operating part 22 and the prongs 52A and 52B are retracted to the proximal position. Furthermore, in the closed configuration, the extended surface 58 of the prong 52B may abut against or be close to the extended surface 54B of the control part 26B. The extended surface of the prong 52A may abut against or be close to the extended surface 54A of the control part 26A.

[0035] The steps shown in Figures 5A to 5D may be performed as many times as necessary during a medical procedure, for example, to capture or manipulate tissue or other material. In this way, the first arm of the forceps 12 may be transitioned from a closed position to an open position by extending one prong, and the second arm of the forceps 12 may be transitioned from an open position to a closed position by retracting one prong.

[0036] Although the end effector is described as forceps 12, the disclosure is not limited in this way. For example, various aspects of the disclosure may be used to form and / or use other end effectors, including pivot elements, extension elements, translation elements, and / or openable elements. For example, the end effector may be a gripper, scissors, clip, stapler, needle, knife, etc.

[0037] Various embodiments 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 forceps or other medical devices. Reducing the number of components enables more efficient assembly, lower material or product structure costs, fewer parts and / or part numbers, reduced likelihood of breakage and / or malfunction, and relaxed size and / or shape tolerances (e.g., no stacking of tolerances due to assembled components). Furthermore, multiple medical devices 10 may be manufactured on the same construction platform, reducing manufacturing and assembly time, costs, etc.

[0038] In addition, 3D printing or additive manufacturing allows the medical device 10 to be smaller in size and / or have a more complex design than conventionally assembled medical devices. As a result, the medical device 10 may be operable and / or deliverable into or through small and / or intricate locations or lumens within a patient. The medical device 10 may also be operated via a drive element, with distal movement of the drive element transitioning the medical device 10 to an open configuration (Figure 2B), and proximal movement of the drive element transitioning the medical device 10 to a closed configuration (Figure 2A). The medical device 10 may also be able to target smaller locations (e.g., smaller portions of tissue) than, for example, larger conventional medical devices.

[0039] Accordingly, the various embodiments discussed herein may help improve the effectiveness of treatment and / or recovery from procedures, such as procedures for treating a treatment site. The various embodiments discussed herein may help reduce and / or minimize the duration of procedures and / or reduce the risk of unintended contact with tissue or other materials during the delivery, repositioning, or use of medical devices in a procedure.

[0040] The principles of this disclosure are described herein with reference to exemplary embodiments for various applications, but it should be understood that this disclosure is not limited thereto. Those skilled in the art and those with access to the teachings provided herein will recognize that additional modifications, applications, embodiments, and substitutions of equivalents all fall within the scope of the embodiments described herein. Therefore, this disclosure should not be considered limited by the foregoing description.

Claims

1. An operating member including an operating part, A hub including a channel for receiving the operating portion of the operating member, wherein the operating portion of the operating member moves within the channel of the hub, A medical device comprising an end effector that is movable between a closed configuration and an open configuration, The distal extension of the operating member causes the end effector to transition to an open configuration. The proximal extension of the operating member causes the end effector to transition to a closed state. The end effector includes a first arm and a second arm, the first arm and the second arm being movable between the closed state and the open state. The distal portion of the operating part includes two prongs that are offset from each other, The extension of one prong causes the first arm to transition from the closed state to the open state, and the retraction of the one prong causes the second arm to transition from the open state to the closed state. The extension of the other prong causes the second arm to transition from the closed state to the open state, and the retraction of the other prong causes the first arm to transition from the open state to the closed state. The aforementioned medical device.

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

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

4. The medical device according to claim 2, wherein the hub includes a plurality of recesses, and the control portion includes a plurality of extensions within the plurality of recesses such that the control portion is pivotably held within the hub.

5. The medical device according to claim 3, wherein each prong includes an extending surface, a receding surface, an inclined surface, and an opening.

6. A medical device, An operating member including an operating part, wherein the operating part includes two prongs, each prong including an extending surface and a retracted surface, and the operating member and A hub including a channel for receiving the operating portion of the operating member, wherein the operating portion of the operating member moves within the channel of the hub, An end effector comprising a first arm and a second arm, wherein each of the first arm and the second arm includes a control portion extending into the hub, and the control portions of the first arm and the second arm each include an extending surface and a receding surface, Includes, The medical device wherein the distal extension of the operating part causes the extended surface of one prong to contact the extended surface of one of the first arm and the second arm, thereby transitioning one of the first arm and the second arm to an open configuration, and the proximal retraction of the operating part causes the retracted surface of one prong to contact the retracted surface of the other of the first arm and the second arm, thereby transitioning the other of the first arm and the second arm to a closed configuration.

7. A medical device, An operating member including an operating part, wherein the operating part includes two prongs, each prong including an opening, and the operating member and A hub including a channel for receiving the operating portion of the operating member, wherein the operating portion of the operating member moves within the channel of the hub, An end effector comprising a first arm and a second arm, wherein each of the first arm and the second arm includes a control portion extending into the hub, and the control portions of the first arm and the second arm each include an extending surface and a receding surface, Includes, The medical device wherein the retracted surfaces of the first arm and the second arm are positioned in the opening within the two prongs in an open configuration.

8. The medical device according to any one of claims 1 to 5, wherein the operating member includes a ring portion, and the hub includes an expanding channel portion having a proximal stop surface and a distal stop surface configured to contact the ring portion and restrict the proximal and distal movement of the operating member.

9. The medical device according to any one of claims 1 to 5, wherein the operating member includes a threaded connecting portion configured to connect the medical device to a drive element.

10. The medical device according to any one of claims 1 to 5, wherein the medical device is made of metal.

11. The medical device according to any one of claims 1 to 5, wherein the medical device is approximately 1 cm in length.

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