Patent Description:
Tissue samples or other materials are often examined to determine the presence of a pathological disorder. Endoscopic biopsy forceps may be used in conjunction with an endoscope for taking samples from the human body for analysis. Often, the samples must be obtained from deep within the body at locations that are difficult to access using standard forceps jaws (e.g., tissue from areas accessible only via tortuous biliary paths). Furthermore, a delivery device (e.g., an endoscope) or the sample site may limit the size of the forceps that can be used to access the tissue. Additionally, manufacturing and/or assembling the forceps jaws may be a costly and/or time-intensive procedure, as forceps (and other end effectors) often include multiple small, discrete, separately-manufactured parts or components that need to be assembled via intricate processes. These concerns may increase the duration, costs, and risks of the medical procedure. The devices and methods of this disclosure may rectify some of the deficiencies described above or address other aspects of the art.

<CIT> discloses a minimally invasive catheter and methods for adjusting the chordae associated with an atrio-ventricular valve and for modifying the geometry of selected cardiac chambers. Clamps carried by the catheter are part of a prosthetic clamp assembly that includes the clamps and a cord attached to each of the clamps. The cord length can be adjusted after the clamps are attached to tissue. The clamps can be operated simultaneously or independently.

<CIT> discloses a forceps that includes a housing defining an internal passageway and a longitudinal axis. First and second jaws are slidably and pivotably connected to the housing. A first connection member having a first end is pivotably attached to the first jaw. A second connection member having a first end is pivotably attached to the second jaw and a driver is pivotably connected to the other ends of the first connection member and the second connection member. The jaws have an open configuration and a closed configuration. Longitudinal movement of the driver in a first direction rotates the first and second jaws relative to the housing from the open configuration towards the closed configuration.

<CIT> discloses medical systems for engaging tissue, e.g. for clipping tissue or closing a perforation or performing hemostasis. Generally, the medical system includes a housing, first and second jaws rotatable relative to the housing, a driver, and an elongate drive wire.

<CIT> discloses a medical device for causing the hemostasis of a blood vessel for use through an endoscope.

<CIT> discloses a head component and a surgical instrument.

No surgical methods are claimed.

Examples of this disclosure relate to, among other things, 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 connection with any of the other disclosed examples.

In one example, a 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 receiving the actuation portion of the operating member. The actuation portion of the operating member may move 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 through an additive manufacturing process.

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 that extends within the hub to interact with the actuation portion. The control portions of the first and second arms each may include an extension surface and a retraction surface offset from the extension surface. The hub may include indentations and the control portions may include extensions within the indentations, to pivotably hold the control portions within the hub. A distal portion of the actuation portion may include two prongs offset from each other, and each prong may include an extension face, a retraction face, an angled face, and an opening. Distal extension of the actuation portion may cause the extension face of one prong to contact the extension surface of one of the first and second arms and transition the one of the first and second arms to the open configuration. Proximal retraction of the actuation portion may cause the retraction face of the one prong to contact the retraction surface of the other one of the first and second arms and may transition the other one of the first and second arms to the closed configuration. The retraction surfaces of the first and second arms may be positioned within the openings in the prongs in the open configuration. The operating member may include a ring portion, and the hub may include a widened channel portion with proximal and distal stop surfaces that are configured to abut the ring portion to limit proximal and distal movement of the operating member.

The operating member may include a threaded coupling portion configured to couple the medical device to a 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 with a laser 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 be exposed to one or more post-processing procedures after separation of the one or more support structures. The medical device may be approximately <NUM> in length.

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 each other, and each prong may include an extension face and a retraction face. The hub may include a channel receiving 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 that extends within the hub to interact with the actuation portion of the operating member. The control portions of the first and second arms each may include an extension surface and a retraction surface offset from the extension surface. Distal extension of the actuation portion may cause the extension face of one prong to contact the extension surface of one of the first and second arms and may transition the one of the first and second arms to the open configuration. Proximal retraction of the actuation portion may cause the retraction face of the one prong to contact the retraction surface of the other one of the first and second arms and may transition the other one of the first and second arms to the closed configuration.

The medical device may include one or more of the following features. Each of the two prongs may include an opening positioned proximal of the retraction face, and the retraction surfaces of the first and second arms may be positioned within 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 a drive element. The hub may include a widened channel portion with proximal and distal stop surfaces that are configured to abut the ring portion to limit proximal and distal movement of the operating member. The medical device may be formed of a metallic material via an additive manufacturing process.

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 each other, and each prong may include an extension face and a retraction face. The hub may include a channel receiving 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 that extends within the hub to interact with the actuation portion. The control portions of the first and second arms each may include an extension surface and a retraction surface offset from the extension 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 distally extending the operating member such that the extension face of one prong contacts the extension surface of one of the first and second arms and transitions the 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 proximally retracting the operating member such that the retraction face of the one prong contacts the retraction surface of the other one of the first and second arms and transitions the other one of the first and second arms to the closed configuration.

It may be understood that both the foregoing general description and the following detailed description are exemplary and explanatory only and are not restrictive of the disclosure, as claimed.

The terms "proximal" and "distal" are used herein to refer to the relative positions of the components of an exemplary medical system and exemplary medical devices. When used herein, "proximal" refers to a position relatively closer to the exterior of the body or closer to a medical professional using the medical system or medical device. In contrast, "distal" refers to a position relatively further away from the medical professional using the medical system or medical device, or closer to the interior 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 that comprises a list of elements does not include only those elements, but may include other elements not expressly listed or inherent thereto. Unless stated otherwise, 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 +/- <NUM>% of a stated value.

Examples of this disclosure include devices and methods for facilitating and/or improving the efficacy, efficiency, and/or safety of a medical procedure. Embodiments of the disclosure may relate to devices and methods for performing various medical procedures and/or treating portions of the large intestine (colon), small intestine, cecum, esophagus, stomach, any other portion of the gastrointestinal tract, kidney or other portion of the urinary tract, heart, lungs, and/or any other suitable patient anatomy. Various embodiments described herein include single-use or disposable medical devices. Some aspects of the disclosure may be used in performing an endoscopic, arthroscopic, bronchoscopic, ureteroscopic, colonoscopic, or other type of procedure. 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 of the elements discussed herein could be metallic, plastic, or include a shape memory metal (such as nitinol), a shape memory polymer, a polymer, or any combination of biocompatible materials.

Reference will now be made in detail to examples of the disclosure described above and illustrated in the accompanying drawings. It is noted that one or more aspects of the medical devices discussed herein may be combined and/or used with one or more aspects of other medical devices discussed herein.

<FIG> illustrates a perspective view of an exemplary medical device <NUM> in an open configuration. Medical device <NUM> includes an end effector, for example, a forceps <NUM> at a distal end, an operating member <NUM> at a proximal end, and a hub <NUM> coupling forceps <NUM> and operating member <NUM>. Forceps <NUM> includes a first arm 18A and a second arm 18B. Operating member <NUM> includes a coupling portion <NUM> and an actuation portion <NUM>. Movement of operating member <NUM> (e.g., distally or proximally along a longitudinal axis A of medical device <NUM>) transitions arms 18A and 18B of forceps <NUM> between a closed configuration (<FIG>) and an open configuration (<FIG>). In examples discussed herein, medical device <NUM> is formed via a three-dimensional printing or additive manufacturing process.

Arms 18A and 18B of forceps <NUM> may include a plurality of teeth 24A and 24B formed by a plurality of extensions and indentations (peaks and valleys) on an internal face of each of arms 18A and 18B. Arms 18A and 18B may also include tooth-free portions, for example, at a proximal end and/or a distal end of each of arms 18A and 18B. Additionally, arms 18A and 18B each include proximal control portions 26A and 26B that extend into hub <NUM>. For example, hub <NUM> includes distal openings <NUM>, and control portions 26A and 26B extend through respective distal openings <NUM>. As discussed below, control portions 26A and 26B may interact with actuation portion <NUM> to control the opening and closing of arms 18A and 18B. In these aspects, arms 18A and 18B may be substantially identical, but mirror images. Furthermore, although not shown, in some aspects, 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 teeth 24A and 24B, for example, from the interior face of arms 18A and 18B to an exterior face of arms 18A and 18B. The one or more drainage holes may help to allow fluid to drain or otherwise flow out of forceps <NUM>. In these aspects, the one or more drainage holes may be formed during the formation of medical device <NUM>, for example, during the three-dimensional printing or additive manufacturing process.

Operating member <NUM> may be configured to couple a drive element (e.g., a drive wire) to medical device <NUM>. For example, as shown, coupling portion <NUM> may include a threading, for example, to couple the drive element to operating member <NUM>. However, this disclosure is not so limited, as coupling portion <NUM> may include other or additional coupling mechanisms, for example, an opening to form a press-fit or snap-fit coupling. Furthermore, although not shown, coupling portion <NUM> may be coupled to the drive element via soldering, welding, etc. Moreover, although also not shown, a sheath or tube may be coupled to hub <NUM> (e.g., coupled to a proximal portion of hub <NUM>). For example, the sheath may be coupled to hub <NUM> via an adhesive. In this aspect, one or more portions of an outer surface of hub <NUM> may include lattice structures and/or rough surfaces, which may help the adhesion of the sheath to hub <NUM>. In this manner, the drive element may be movable relative to the sheath (e.g., within a lumen of the sheath), via a proximal handle, for example, to control the movement of operating member <NUM> relative to hub <NUM>.

Actuation portion <NUM> may be substantially cylindrical, and extends distally of coupling portion <NUM>. Actuation portion <NUM> may extend through a proximal opening (not shown) in hub <NUM>, and may be movable (proximally and/or distally) relative to hub <NUM> to control the position of arms 18A and 18B. For example, a distal portion of actuation portion <NUM> may interact with control portions 26A and 26B of arms 18A and 18B to control the opening and/or closing of arms 18A and 18B. Furthermore, actuation portion <NUM> may include one or more indications <NUM>, which may help a user visualize the position of actuation portion <NUM> relative to hub <NUM>, for example, via a visualization device (e.g., camera) positioned at a treatment site. The position of indication(s) <NUM> on actuation portion <NUM> may be indicative of the configuration of forceps <NUM>, as shown in <FIG>. In some aspects, indication(s) <NUM> may be radiopaque, and thus may be visualized via an X-ray or other visualization device outside of the patient.

As mentioned, hub <NUM> encloses portions of forceps <NUM> and operating member <NUM>. Hub <NUM> includes distal openings <NUM> to receive control portions 26A and 26B of arms 18A and 18B. Additionally, although not shown, hub <NUM> includes a proximal opening to receive a portion of actuation portion <NUM>. The proximal opening and distal openings <NUM> connect within hub <NUM> to form a channel <NUM> (<FIG>) within hub <NUM>. One or more portions of channel <NUM> may be generally cylindrical. Actuation portion <NUM> is movable within a portion of channel <NUM>, and control portions 26A and 26B may be pivotably held or retained within a distal portion of channel <NUM>.

<FIG> illustrates medical device <NUM> in a closed configuration, and <FIG> illustrates medical device <NUM> in an open configuration. In <FIG>, operating member <NUM>, and thus actuation portion <NUM>, is in a proximally retracted position relative to hub <NUM>. Accordingly, arms 18A and 18B of forceps <NUM> are in a closed configuration, for example, with teeth 24A of arm 18A in contact with or close to teeth 24B of arm 18B. In <FIG>, operating member <NUM>, and thus actuation portion <NUM>, is in a distally extended position relative to hub <NUM>, for example, with a greater portion of actuation portion <NUM> extended into hub <NUM>. Accordingly, arms 18A and 18B of forceps <NUM> are in an open configuration, for example, with teeth 24A of arm 18A spaced apart from teeth 24B of arm <NUM>. Although not shown, medical device <NUM> may include one or more springs or biasing elements (e.g., internal to hub <NUM> or within a proximal handle (not shown)), which may bias medical device <NUM> toward the closed configuration or toward the open configuration.

As shown in <FIG>, medical device <NUM> may be formed via a three-dimensional printing or additive manufacturing process. For example, a plurality of layers of material (e.g., layers of approximately <NUM> microns to approximately <NUM> microns thick, for example, approximately <NUM> microns thick) may be deposited on a build platform (not shown), and portions of the layers may be selectively sintered to form medical device <NUM>. Portions of the layers may be sintered using a laser source. The layers of material may be determined using a three-dimensional model (e.g., a 3D CAD model) of medical device <NUM> and a slicing software. In this aspect, layers of powder (e.g., a metallic powder) may be successively applied to the build platform, and portions of each layer may be melted (e.g., with the laser source) to solidify the powder and, optionally, solidify the portion of the layer to a layer beneath it. The laser source only fires on the build platform in one or more locations that define the part geometry for each particular layer. Furthermore, the laser source does not fire to melt other portion(s) of the layer that do not define the part geometry, for example, portion(s) of the layer that form a cavity in that layer. The portion(s) of the layer that do not define the part geometry remain as powder. The powder may be removed from the part during post-processing.

Moreover, one or more sacrificial or support structures <NUM> may be built to help support portions of medical device <NUM> during the formation process. For example, as shown in <FIG>, medical device <NUM>, including one or more sacrificial or support structures <NUM>, may be built vertically on the build platform. The location and/or size of the one or more support structures <NUM> may be determined and implemented by the slicing software. For example, a support structure <NUM> may be formed to help support arms 18A and 18B of forceps <NUM>. Support structure <NUM> may then be separated from forceps <NUM> after the formation process, for example, via a wire electrical discharge machining process. Although not shown, additional support structures may support coupling portion <NUM> and actuation portion <NUM> of operating member <NUM>, hub <NUM>, etc. during the formation process, and may be removed after formation. The separation of the one or more support structures <NUM> may also help to separate components (e.g., arms 18A and 18B from hub <NUM>) in order for the components to be movable relative to one another.

Medical device <NUM> may be formed of a biocompatible metallic material, for example, stainless steel, titanium, etc. In this aspect, layers of a metallic powder may be deposited on the build platform, and selectively sintered to form layers of medical device <NUM>. The one or more support structures <NUM> may be formed of the same metallic material, or may be formed of another material. Furthermore, one or more surface treatments or post-processing techniques or procedures (e.g., electropolishing, chemical etching, etc.) may be performed on medical device <NUM>, for example, to smooth the surfaces of medical device <NUM> after separation from support structure(s) <NUM>. Thus, once medical device <NUM> is formed, after support structure <NUM> is removed from medical device <NUM>, and any post-processing procedures are performed, medical device <NUM> may be ready for use and not require additional assembly, except for the connection to a drive element, sheath, handle etc. Accordingly, unlike typical end effectors with multiple small, discrete, separately-manufactured parts that require assembly, medical device <NUM> does not require assembly other than mounting medical device <NUM> to control elements (e.g., a drive wire and a sheath).

Furthermore, based on medical device <NUM> being formed via a three dimensional printing or additive manufacturing process, medical device <NUM> may be smaller than typical medical devices or end effectors that include forceps. For example, as discussed above, portions of medical device <NUM> do not need to be connected to or otherwise coupled to other portions of medical device <NUM>. In this aspect, medical device <NUM> may be approximately <NUM> or smaller in length, for example, approximately <NUM> in length, approximately <NUM> in length, approximately <NUM> in length, or approximately <NUM> in length (e.g., approximately <NUM> in length). Medical device <NUM> may be approximately <NUM> or smaller in width, for example, approximately <NUM> in width, approximately <NUM>-<NUM> in width, or approximately <NUM> in width. Additionally, in the open configuration, arms 18A and 18B of forceps <NUM> may form an opening (e.g., between the distal ends of arms 18A and 18B) that is approximately <NUM> to <NUM> in width, for example, approximately <NUM> in width.

<FIG> are different views of medical device <NUM>, with hub <NUM> shown as being transparent. <FIG> is a side view of medical device <NUM>, and shows arms 18A and 18B of forceps <NUM>. <FIG> is a top view of medical device <NUM>, for example, with medical device <NUM> rotated approximately <NUM> degrees along its longitudinal axis A (<FIG>), and shows arm 18A of forceps <NUM>, as arm 18B is blocked by arm 18A. <FIG> is an enlarged view of a portion of <FIG>.

As shown in <FIG>, arms 18A and 18B each include control portions 26A and 26B, respectively, which are positioned within hub <NUM>. Control portions 26A and 26B are offset from a center of medical device <NUM> in a direction perpendicular to longitudinal axis A (e.g., horizontally offset and/or into the page in <FIG> and <FIG>). For example, as shown in <FIG> and <FIG>, control portion 26B is above and to the left of a portion of control portion 26A. Control portions 26A and 2B are pivotable (via action from actuation portion <NUM>) to transition arms 18A and 18B between the closed and open configurations. As mentioned, actuation portion <NUM> extends within hub <NUM>. Actuation portion <NUM> includes a distal end <NUM> that is configured to contact and move control portions 26A and 26B to transition arms 18A and 18B between the closed and open configurations. Distal end <NUM> and control portions 26A and 26B interact in a distal portion <NUM> of channel <NUM>, as shown in <FIG>.

Moreover, actuation portion <NUM> includes a radial extension or ring portion <NUM>, and hub <NUM> includes a widened channel <NUM> with a proximal stop surface 46A and a distal stop surface 46B. Ring portion <NUM> is positioned within widened channel <NUM>, and proximal stop surface 46A and distal stop surface 46B limit the proximal and distal movement of actuation portion <NUM>, and thus of operating member <NUM>, relative to hub <NUM>.

As shown in <FIG>, medical device <NUM> may also include a contained conical hinge design. For example, hub <NUM> may include two indentations 48A and 48B that each extend radially outward in a generally conical shape. Control portions 26A and 26B of arms 18A and 18B may include extensions 50A and 50B, which may also have a generally conical shape. For example, <FIG> illustrates control portion 26A extending through distal opening 28A. Extensions 50A and 50B may be received and movable within indentations 48A and 48B, such that control portions 26A and 26B of arms 18A and 18B are retained within hub <NUM>, and such that arms 18A and 18B are able to pivot between the closed and open configurations.

Additionally, distal end <NUM> of actuation portion <NUM> includes two prongs 52A and 52B. Prongs 52A and 52B are movable with actuation portion <NUM> and interact with control portions 26A and 26B to transition arms 18A and 18B between the closed and open configurations.

<FIG> illustrate further details of the interaction of actuation portion <NUM> with arms 18A and 18B within hub <NUM>. <FIG> illustrates the transition from the closed configuration to the open configuration. For example, medical device <NUM> may be delivered to a treatment site, and actuation portion <NUM> and prongs 52A and 52B are extended distally (as shown by the vertical arrow), which pivots control portions 26A and 26B to separate and open arms 18A and 18B. Actuation portion <NUM> may be extended distally via action of the drive element coupled to coupling portion <NUM>. In this aspect, control portions 26A and 26B each include an extension surface 54A and 54B and a retraction surface 56A and 56B. Extension surface 54A may be offset in a direction perpendicular to longitudinal axis A (e.g., laterally offset and offset in a direction out of the page in <FIG>) from retraction surface 56A. In this aspect, as shown in <FIG>, extension surface 54A may be above retraction surface 56A. Similarly, extension surface 54B may be offset in the direction perpendicular to longitudinal axis A (e.g., laterally offset and offset in a direction out of the page in <FIG>) from retraction surface 56B. In this aspect, as shown in <FIG>, extension surface 54B may be below retraction surface 56B.

Prongs 52A and 52B are offset from each other in the direction perpendicular to longitudinal axis A (e.g., laterally offset and offset in a direction out of the page in <FIG>). In this aspect, as shown in the side views of <FIG>, prong 52B is above prong 52A. Prongs 52A and 52B each include an extension face <NUM>, a retraction face <NUM>, and an angled face <NUM>. The Figures show only extension face <NUM>, retraction face <NUM>, and angled face <NUM> for prong 52B. Extension face <NUM> of prong 52B may be perpendicular to longitudinal axis A (<FIG>), and extension face <NUM> of prong 52B may contact and ride along extension surface 54B of control portion 26B to pivot arm 18B toward the open configuration. Although not shown, the extension face of prong 52A also may be perpendicular to longitudinal axis A and may contact and ride along the extension surface of control portion 26A to pivot arm 18A toward the open configuration. Similar to arms 18A and 18B, prong 52B may be a mirror image or have an inverse arrangement of prong 52A.

<FIG> illustrates medical device <NUM> in the open configuration. As shown, ring portion <NUM> may abut or be close to distal stop surface 46B, and arms 18A and 18B are separated. Moreover, angled face <NUM>, which extends proximally at an angle from extension face <NUM>, may be in contact with extension surface 54B of control portion 26B of arm 18B, along all or a substantial portion of extension surface 54B. Although not shown, the extension face of prong 52A may be in contact with the extension surface of control portion 26A of arm 18A. Moreover, retraction surface 56A of arm 18A may be positioned within an opening <NUM> of prong 52B, for example, proximal of retraction face <NUM>. As shown, retraction face <NUM> is positioned proximal to extension face <NUM>, and extends at an angle configured to correspond to (e.g., match and/or abut) retraction surface 56A of control portion 26A. Furthermore, although not shown, retraction surface 56B of arm 18B may be positioned within an opening of prong 52A.

<FIG> illustrates the transition from the open configuration to the closed configuration, for example, to capture or otherwise treat tissue or other material at a treatment site. For example, actuation portion <NUM> and prongs 52A and 52B are retracted proximally (as shown by the vertical arrow), which pivots control portions 26A and 26B to close arms 18A and 18B. Actuation portion <NUM> may be retracted proximally via action of the drive element coupled to coupling portion <NUM>. In this aspect, retraction face <NUM> of prong 52B contacts retraction surface 56A of control portion 26A, and pivots arm 18A toward the closed configuration. Similarly, although not shown, the retraction face of prong 52A contacts the retraction surface of control portion 26B, and pivots arm 18B toward the closed configuration.

<FIG> illustrates the closed configuration. In this aspect, actuation portion <NUM> and prongs 52A and 52B are proximally retracted. Moreover, in the closed configuration, extension face <NUM> of prong 52B may abut or be close to extension surface 54B of control portion 26B. The extension face of prong 52A may abut or be close to extension surface 54A of control portion 26A.

The steps shown in <FIG> 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, the extension of one prong transitions a first arm of forceps <NUM> from the closed configuration to the open configuration, and retraction of the one prong transitions a second arm of forceps <NUM> from the open configuration to the closed configuration.

Although the end effector is described as forceps <NUM>, this disclosure is not so limited. For example, various aspects of this disclosure may be used to form and/or use other end effectors that include pivoting, expandable, translatable, and/or openable elements. For example, the end effector may be a grasper, scissors, a clip, a stapler, a needle, a knife, etc..

Various aspects discussed herein may help to reduce the duration, costs, and/or risks of a medical procedure. For example, three-dimensional printing and/or additive manufacturing may help to reduce the number of necessary components to form a forceps or other medical device. Reducing the number of components allows for more efficient assembly, a reduced bill of materials or product structure, a reduced number of parts and/or part numbers, a reduced likelihood of breakage and/or malfunction, more lenient size and/or shape tolerances (e.g., no stacking of tolerances with assembled components), etc. Furthermore, a plurality of medical devices <NUM> may be manufactured on the same build platform, reducing manufacturing and assembly time, costs, etc..

Additionally, three-dimensional printing or additive manufacturing allows for medical device <NUM> to be a smaller size and/or have more complex designs than traditionally assembled medical devices. As a result, medical device <NUM> may be maneuverable and/or deliverable to or through small and/or tortuous locations or lumens in a patient. Medical device <NUM> may be operated via a drive element, with distal movement of the drive element transitioning medical device <NUM> to the open configuration (<FIG>), and proximal movement of the drive element transitioning medical device <NUM> to the closed configuration (<FIG>). Medical device <NUM> may also be able to target smaller locations (e.g., smaller portions of tissue), for example, than larger traditional medical devices.

Accordingly, various aspects discussed herein may help to improve the efficacy of treatment and/or recovery from a procedure, for example, a procedure to treat a treatment site. Various aspects discussed herein may help to reduce and/or minimize the duration of the procedure, and/or may help reduce risks of inadvertent contact with tissue or other material during delivery, repositioning, or usage of a medical device in the procedure.

Claim 1:
A medical device (<NUM>), comprising:
an operating member (<NUM>) that includes an actuation portion (<NUM>);
a hub (<NUM>) that includes a channel receiving the actuation portion (<NUM>) of the operating member (<NUM>), wherein the actuation portion (<NUM>) of the operating member (<NUM>) moves within the channel; and
an end effector, wherein the end effector is movable between a closed configuration and an open configuration,
wherein distal extension of the operating member (<NUM>) transitions the end effector to the open configuration,
wherein proximal retraction of the operating member (<NUM>) transitions the end effector to the closed configuration,
wherein the end effector includes a first arm (18A) and a second arm (18B) and wherein the first arm and the second arm are movable between a closed and an open position,
wherein a distal portion (<NUM>) of the actuation portion (<NUM>) includes two prongs (52A, 52B) offset from each other and an extension of one prong transitions the first arm from the closed configuration to the open configuration, and retraction of the one prong transitions the second arm from the open configuration to the closed
configuration, and an extension of the other prong transitions the second arm from the closed configuration to the open configuration, and retraction of the other prong transitions the first arm from the open configuration to the closed configuration; and
wherein the medical device (<NUM>) is formed through an additive manufacturing process.