Abstract: Various embodiments of craniofacial implants, surgical instruments, and techniques are described to provide improved surgical results.

Abstract: A curved surgical fastener for anchoring medical devices to tissue includes a curved member having a proximal end, a distal end, and a tissue penetrating end at the distal end of the curved member. The curved member has a total curvature of less than 360 degrees between the proximal and distal ends. The proximal end of the curved member lies in a first plane, the distal end of the curved member lies in a second plane that is offset from the first plane, and the curved member has an intermediate section that extends between the first and second planes. The curved member includes a compound curve having a proximal section with a first radius of curvature and a distal section with a second radius of curvature that is different than the first radius of curvature.

Abstract: A vascular filter device (1) comprises a plurality of filter elements (6) which are movable from a capturing position to an open position upon elapse of a predetermined period of time. In the capturing position the filter elements (6) are configured to capture thrombus passing through the inferior vena cava. In the open position the filter elements (6) are configured to facilitate unrestricted blood flow. The filter elements (6) are biased towards the open position. The filter (1) comprises a holder member (10) to temporarily hold the filter elements (6) in the capturing position until elapse of the predetermined period of time. The holder member (10) comprises a biostable wire element (12) which extends through an opening (13) in each filter element (6), and a biodegradable/bioabsorbable stop element (11). Upon biodegrading/bioabsorbing of the stop element (11), the filter elements (6) are free to move from the capturing position to the open position.

Abstract: A urological repair device includes a stent having a diameter that fits within a portion of a urological structure. The stent also has a length to bridge a distance between a first end of the urological structure and a second end of the urological structure. The stent includes at least one tapered end. The tapered end enables placement of the stent within the urological structure. A method of repairing a urological structure includes placing a first end of a substantially tubular urological structure over a first end of a tubular stent, and placing a second end of a substantially tubular urological structure over a second end of a stent, and attaching the first end of the substantially tubular urological structure, the second end of a substantially tubular urological structure, and the tubular stent to form a fluid passageway.

Abstract: A blood vessel dissecting device includes: a dissecting device which, when inserted into a living body along a blood vessel, dissects tissue in a direction of alignment of the dissecting device with the blood vessel; and a cutting device which, when inserted into the living body along the blood vessel, cuts tissue surrounding the blood vessel in a direction of alignment of the cutting device with the blood vessel. A blood vessel dissecting method includes: inserting a dissecting device into a living body along a blood vessel so as to dissect tissue in a direction of alignment of the dissecting device with the blood vessel; and inserting a cutting device into the living body along the blood vessel while guiding the cutting device with the dissecting device so as to cut tissue surrounding the blood vessel in a direction of alignment of the cutting device with the blood vessel.

Abstract: The present invention relates to devices and methods for the treatment of diseases in the vasculature, and more specifically, devices and methods for treatment of aneurysms found in blood vessels. In a first embodiment of the present invention, a two part prostheses, where one part is an expandable sponge structure and the other part is an expandable tubular mesh structure, is provided. In the first embodiment, the expandable sponge structure is intended to fill the aneurysm cavity to prevent further dilatation of the vessel wall by creating a buffer or barrier between the pressurized pulsating blood flow and the thinning vessel wall. In the first embodiment, the expandable tubular mesh structure is placed across the aneurysm, contacting the inner wall of healthy vessel proximal and distal to the aneurysm.

Abstract: The present invention relates to devices and methods for the treatment of diseases in the vasculature, and more specifically, devices and methods for treatment of aneurysms found in blood vessels. In one embodiment, a system for treating an aneurysm is disclosed. The system comprises a catheter delivery system, an expandable foam configured to pass through the catheter delivery system, and a stent having a first end and a second end. The stent is configured to extend across the aneurysm. The expandable foam is configured to expand in the aneurysm when exposed to a fluid.

Abstract: An apparatus includes a first stent graft that is at least partially insertable into a first blood vessel. The first stent graft has a first end, a second end, an inside surface, and an outside surface. The apparatus also includes an inflatable fill structure fixed to a portion of the outside surface of the first stent graft. The inflatable fill structure includes an outer membrane that is configured to extend beyond the first end of the first stent graft when the inflatable fill structure is in a filled state.

Abstract: This invention is a system for the treatment of body passageways; in particular, vessels with vascular disease. The system includes an endovascular graft with a low-profile delivery configuration and a deployed configuration in which it conforms to the morphology of the vessel or body passageway to be treated as well as various connector members and stents. The graft is made from an inflatable graft body section and may be bifurcated. One or more inflatable cuffs may be disposed at either end of the graft body section. At least one inflatable channel is disposed between and in fluid communication with the inflatable cuffs.

Abstract: An implantable article for attaching tendons and/or ligaments to bone and/or cartilage, assemblies thereof, and methods of use thereof are provided. The implantable article is configured for attaching at least one of a tendon and a ligament to at least one of bone and cartilage. The article comprises a membrane comprising a biological material that promotes cell growth. The membrane comprises an open end configured to receive a cell growth mixture, a closed end configured to be attached to the at least one of bone and cartilage, and a cavity extending from the open end to the closed end. The cavity is configured to receive the cell growth mixture from the open end.

Abstract: An intraocular lens 1 includes a lens 2 and a haptic 3 connected to the lens 2. The lens 2 is disposed behind an iris 7 in an eye of a patient. The haptic 3 has a main body 3a and first and second projections 3d and 3e. The main body 3a extends from the lens 2 outward in a radial direction about a visual axis C of the patient. The first and second projections 3d and 3e are located so as to project from the main body 3a toward spaces between a plurality of ciliary zonules 10 connecting a crystalline lens 11 and a ciliary body 8 in the eye. Accordingly, an intraocular lens and a haptic for an intraocular lens that are able to inhibit the position of a lens from being displaced are provided.

Abstract: The invention relates to novel optical elements having improved UV protection. The optical element comprises a light adjustable optical element with a UV absorbent layer applied to at least one surface of the optical element. The invention is particularly useful in light adjustable intraocular lenses.

Abstract: An intraocular lens (IOL) insertion apparatus includes a handpiece body having a distal tip and a proximal section. The IOL insertion apparatus also includes a folding chamber located within the handpiece body, the folding chamber shaped to fold an IOL advancing through the folding chamber. The IOL insertion apparatus also includes an advancement system. The advancement system includes an advancement carriage movable between a first position and a second position within the handpiece body. The advancement carriage includes a spring system biasing the advancement carriage in a distal direction toward the second position and a dampening system to dampen motion of the advancement carriage. The advancement system further includes an elongated advancement plunger that includes a distal end to advance the IOL through the folding chamber and a proximal end connected to the advancement carriage.

Abstract: Embodiments of prosthetic valves for implantation within a native mitral valve are provided. A prosthetic valve may comprise a radially compressible main body and a one-way valve portion. The prosthetic valve may further comprise one or more ventricular anchors coupled to the main body and disposed outside of the main body. The ventricular anchors may be configured such that a reduced profile of the prosthetic valve is possible. A space may be provided between an outer surface of the main body and the ventricular anchors for receiving native mitral valve leaflets. The prosthetic valve may include an atrial sealing member adapted for placement above the annulus of the mitral valve. Methods and devices for receiving the native mitral valve leaflets between the ventricular anchors and the main body are described.

Abstract: In some embodiments, a method includes delivering to a native valve annulus (e.g., a native mitral valve annulus) of a heart a prosthetic heart valve having a body expandable from a collapsed, delivery configuration to an expanded, deployed configuration. The method can further include, after the delivering, causing the prosthetic heart valve to move from the delivery configuration to the deployed configuration. With the prosthetic heart valve in its deployed configuration, an anchor can be delivered and secured to at least one of a fibrous trigone of the heart or an anterior native leaflet of the native valve. With the prosthetic heart valve disposed in the native valve annulus and in its deployed configuration, an anchoring tether can extending from the anchor can be secured to a wall of the heart to urge the anterior native leaflet towards the body of the prosthetic heart valve.

Abstract: Thin, biocompatible, high-strength, composite materials are disclosed that are suitable for use in a valve for regulating blood flow direction. In one aspect, the composite material maintains flexibility in high-cycle flexural applications, making it particularly applicable to high-flex implants such as a prosthetic heart valve leaflet. The composite material includes a porous polymer membrane and an elastomer, wherein the elastomer fills substantially all of the pores of the porous polymer membrane.

Abstract: A heart valve bioprosthesis (100) and a manufacturing method thereof are provided. The heart valve bioprosthesis (100) comprises: a support frame (1), valve leaflets (2) and a valve auxiliary structure. The valve leaflets (2) are connected to the valve auxiliary structure, the valve auxiliary structure is connected to the support frame (1). Both the valve leaflets (2) and the valve auxiliary structure are made of biological tissues. The support frame (1) is formed as a single component with an elastic material, and the valve auxiliary structure is preset with suturing marks. The heart valve bioprosthesis improves the biocompatibility with the human body, reduces the total height of the valve, shortens the suturing time, and decreases the possibility of thrombus or bacterial attachment thereto. In addition, the heart valve bioprosthesis is made by a simple process, exhibit excellent compliance with the cardiac tissue, and has a prolonged service life.

Abstract: A method of assembling a prosthetic heart valve includes providing a collapsible and expandable stent having an annulus section and an aortic section. The annulus section has a first diameter in a relaxed condition and a second diameter less than the first diameter in a collapsed condition. A constraint is applied to the stent to constrain the annulus section to a predetermined diameter between the first and second diameters. Applying a cuff and/or a plurality of leaflets to the stent in the constrained condition enables less material to be used. The resultant prosthetic valve is therefore able to be collapsed to a smaller diameter for introduction into a patient.

Abstract: A prosthetic mitral valve includes an anchor assembly, a strut frame, and a plurality of replacement leaflets secured to the annular strut frame. The anchor assembly includes a ventricular anchor, an atrial anchor, and a central portion therebetween. The ventricular anchor and the atrial anchor are configured to flare radially outwards relative to the central portion. The annular strut frame is disposed radially within the anchor assembly and is attached to the anchor assembly. The central portion is configured to align with a native valve orifice and the ventricular anchor and the atrial anchor are configured to compress native cardiac tissue therebetween.

Abstract: During a percutaneous procedure, a flexible sleeve of an annuloplasty structure is introduced into an atrium and arranged completely around an annulus as a closed loop, such that none of one or more longitudinal contracting members thereof is positioned along an anterior portion of the annulus between fibrous trigones of the valve. The annuloplasty structure is fastened to the annulus. At least a portion of a posterior portion of the annulus is tightened, while preserving a length of an anterior portion of the annulus between fibrous trigones of the valve, by contracting, using the one or more longitudinal contracting members, a longitudinal portion of the sleeve not positioned along the anterior portion of the annulus between the fibrous trigones of the valve. Thereafter, the one or more longitudinal contracting members are locked.

Abstract: Implants, implant systems, and methods for treatment of mitral valve regurgitation and other valve diseases generally include a coaptation assist body which remains within the blood flow path as the leaflets of the valve move, the valve bodies often being relatively thin, elongate (along the blood flow path), and/or conformable structures which extend laterally from commissure to commissure, allowing the native leaflets to engage and seal against the large, opposed surfaces on either side of the valve body during the heart cycle phase when the ventricle contracts to empty that chamber of blood, and allows blood to pass around the valve body so that blood flows from the atrium to the ventricle during the filling phase of the heart cycle. Separate deployment of independent anchors near each of the commissures may facilitate positioning and support of an exemplary triangular valve body, with a third anchor being deployed in the ventricle.

Abstract: A catheter member for interacting with a circumferential tissue structure includes: an elongate primary catheter having at least one inner lumen and extending along a longitudinal axis; first and second elongate secondary catheters, each having an inner lumen, and each positionable in an inner lumen of the primary catheter to be moveable relatively thereto and exposable therefrom; and a first flexing mechanism to provide a distal end portion of the first and/or second secondary catheter with a tendency to assume a first secondary bent shape. The distal end portion of the first and/or second secondary catheters is provided so as to be able to be flexed by the first flexing mechanism to form an arm portion substantially transverse to the direction of the longitudinal axis of the primary catheter so as to assume the first secondary bent shape when exposed from a distal end portion of the primary catheter.

Abstract: A medical implant for cartilage repair at an articulating surface of a joint includes a contoured, substantially plate shaped, implant body and at least one extending post. The implant body has an articulate surface configured to face the articulating part of the joint and a bone contact surface configured to face the bone structure of a joint, where the articulate and bone contact surfaces face mutually opposite directions and the bone contact surface is provided with the extending post. A cartilage contact surface connects the articulate and the bone contact surfaces and is configured to contact the cartilage surrounding the implant body in a joint. The cartilage contact surface has a coating that substantially only includes a bioactive material.

Abstract: A method for designing and making a rig that includes a hollow tubular shell, and the interior of said shell defines at least first and second intersecting cylinders. The method includes identifying a damage area, presenting a 3D view of identified damage area, generating a 3D model of a virtual rig, and producing a rig according to the virtually created rig. The generating includes virtually placing in 3D view a shape covering or partly covering damage area, and creating, based on the position of the virtually placed shape, a position of hollow tubular rig shell of the virtual rig; and selecting the at least first and second intersecting cylinders of the virtual rig, based on the size and form of the virtually placed shape, and creating a positioning surface of the virtual rig which is a bone and/or cartilage-engaging end of hollow tubular shell.

Abstract: Herein disclosed is a tissue supplied in a configuration pre-shaped to the topography of the recipient surface for covering defects in the articulating surfaces of bones. Also discussed herein is a method of preparing a graft for reconstruction of a defect in an articular surface of a bone comprising determining the topography of the native articular surface and the corresponding underside of the cartilage layer; fabricating a pair of mating surfaces having the topography of the native articular surface and the underside of the cartilage layer; harvesting a cartilage graft from a cadaveric donor; and placing said graft between the mating surfaces and subjecting said graft to sufficient pressure for a sufficient duration to cause it to change shape to that of the deforming surfaces.

Abstract: The present invention relates to an insert unit inserted during an artificial knee joint operation. An insert unit for an artificial knee joint according to an embodiment of the present invention includes a tibial member configured for coupling to the end of the tibia during an artificial knee joint operation, an insert configured for coupling to an upper side of the tibial member, and a locking rod coupling together the tibial member and the insert by penetrating through the tibial member and the insert, wherein the locking rod comprises a head portion formed at the upper end, and the head portion comprises a lip protruding outward to provide a constraint in relation to the insert during an articular movement such that the locking rod does not dig into the tibial member, to increase a coupling strength of the insert unit.

Abstract: An orthopedic tibial prosthesis includes a tibial baseplate with an asymmetric periphery which promotes proper positioning and orientation on a resected tibia, while also facilitating enhanced kinematics, soft-tissue interaction, and long-term fixation of the complete knee prosthesis. The asymmetric baseplate periphery is sized and shaped to substantially match portions of the periphery of a typical resected proximal tibial surface, such that proper location and orientation is evident by resting the baseplate on the tibia. The baseplate periphery provides strategically positioned relief and/or clearance between the baseplate periphery and bone periphery, such as in the posterior-medial portion to prevent deep-flexion component impingement, and in the anterior-lateral portion to avoid undue interaction between the anatomic iliotibial band and prosthesis components.

Abstract: A medical grade thermoplastic or polymer implant with an osteoconductive coating is provided, specifically for corrections of the distal and proximal interphalangeal toe joints of the foot. The implant can be either straight or angled, and can be either solid or cannulated for insertion. The implant is sized and shaped depending on the specific anatomy and desired correction. End portions of the implant may be coated with an osteoconductive coating that promotes bone growth, but may reduce radiolucency. Thus, a central portion of the implant may remain uncoated to increase radiolucency of the implant at the region where two bones come together.

Abstract: Expandable spinal interbody implants include a body and at least one extendable support element connected thereto. Such an implant may include a second extendable support element and a tool selectively positionable with respect to the implant so as to independently or simultaneously expand both extendable support elements. In another example, such an implant may include, at each of a first and second location, a respective movable member and a respective locking element. The at least one extendable support element may be actuatable to expand so as to induce movement of at least one of the movable members away from the body. The locking elements at each of the first and second locations may be selectively lockable such that, when locked, the locking element restrains movement of the associated movable member at that location away from the body without restraining movement of the other movable member away from the body.

Abstract: Disclosed is a bone fusion cage that contains bone graft and is implanted between bones in a skeletal system. The cage bears structural loads that are transmitted through the bones of the skeletal system and at least partially shields the contained bone graft from the structural loads. The cage is configured to provide a secondary load to the bone graft independent of the structural load to promote fusion of the bone graft to adjacent bones.

Abstract: An implant or endoprosthesis suitable to be implanted in human or animal tissue includes two (or more than two) parts to be joined in situ. Each one of the parts includes a joining location, the two joining locations facing each other when the device parts are positioned for being joined together, wherein one of the joining locations includes a material which is liquefiable by mechanical vibration and the other one of the joining locations includes a material which is not liquefiable by mechanical vibration and a structure (e.g. undercut cavities or protrusions) suitable for forming a positive fit connection with the liquefiable material. The joining process is effected by pressing the two device parts against each other and by applying ultrasonic vibration to one of the device parts when the two parts are positioned relative to each other such that the two joining locations are in contact with each other.

Abstract: A device includes a first endplate having an engagement surface and first and second extensions. The first extension has a first ramp and the second extension has a first slot. A second endplate includes a second engagement surface and third and fourth extensions. The third extension has a second ramp and the fourth extension has a second slot. A wedge is positioned between the endplates and includes a first inclined portion that engages the first ramp and a second inclined portion that engages the second ramp. The wedge has first and second apertures. A first pin extends through the first aperture and the first slot. A second pin extends through the second aperture and the second slot. The wedge is movable relative to the endplates to move the device from a first height to an increased second height. Methods of use are disclosed.

Abstract: An expandable intervertebral fusion implant, including an inferior component, including a first plurality of axial members and a first plurality of cross-members, a superior component, including a second plurality of axial members and a second plurality of cross-members, and at least one locking arm operatively arranged to lock the superior component at a distance from the inferior component.

Abstract: A surgical inserter includes a shaft, a lever, a bolt, and a locking mechanism. The shaft includes a shaft body and an engaging head. An end of the lever is adjacent to an inner side of the engaging head. The bolt is mounted on the end of the lever and passes through the engaging head to connect a medical device. The locking mechanism is movably disposed on the other end of the shaft body for selectively locking or releasing angular movement of the lever relative to the shaft body. When the lever is bending relative to the shaft body, the end of the lever pries the bolt, so that the medical device is driven by the bolt to abut against an outer side of the engaging head tightly.

Abstract: A system and method for allowing any surgeon, including those surgeons who perform a fewer number of a revision procedure as compared to a more experienced surgeon who performs a greater number of procedures, to provide an improved likelihood of a favorable outcome approaching, if not exceeding, a likelihood of a favorable outcome as performed by a very experienced surgeon with the revision procedure. An engine is operable in two distinctive selectable modes including a unidirectional mode providing only extractive forces and a bidirectional mode providing both extractive and insertional forces.

Abstract: An orthopedic joint replacement system is shown and described. The system includes a number of prosthetic components configured to be implanted into a patient's knee. The system also includes a number of surgical instruments configured for use in preparing the bones of the patient's knee to receive the implants. A method or technique for using the surgical instruments to prepare the bones is also disclosed.

Abstract: An orthopaedic joint replacement system is shown and described. The system includes a number of prosthetic components configured to be implanted into a patient's knee. The system also includes a number of surgical instruments configured for use in preparing the bones of the patient's knee to receive the implants. A method or technique for using the surgical instruments to prepare the bones is also disclosed.

Abstract: A distraction kit including at least one trial insert, at least one handle for coupling to the at least one trial insert, a correction indication guide, and at least one implant. A method for performing a distraction arthrodesis including inserting at least one trial insert into a joint and selecting a trial insert of the at least one trial insert for correction of the joint in a first plane. The method also including rotating the selected trial insert in a medial-lateral direction for correction of the joint in a second plane and selecting the needed correction in the first plane and the second plane. The method further including marking at least one bone for the selected correction. Then, marking the implant with the correction indication guide to achieve proper placement of the implant and joint correction replication from the desired trial positioning. Implants, devices, and systems are also disclosed.

Abstract: A human exoskeleton is provided and includes a power source. The human exoskeleton also includes a controller configured to activate power between the exoskeleton and the power source. The human exoskeleton further includes a power disconnect mechanism electronically connected to the controller and configured to disconnect power between the exoskeleton and the battery when activated, the power disconnect mechanism physically in contact with a wearer of the human exoskeleton.

Abstract: Methods for securing strand ends of devices configured for insertion into an anatomical structure, and the resulting devices.

Abstract: The disclosure of the present application provides devices, systems, and methods for the prevention of stroke. In at least one embodiment of a device of the present application, the device comprises an extension portion sized and shaped to fit within an artery extending from an aortic arch, and a flange portion sized and shaped to prevent the device from advancing into the artery extending from the aortic arch in which the device may be positioned. In at least one embodiment of a system for preventing stroke of the present application, the system comprises a hypotube, a folder coupled to a distal end of the hypotube, a sleeve positioned circumferentially around the hypotube proximal to the folder, and a stent, wherein a first part of the stent may be positioned within the folder, and wherein a second part of the stent may be positioned within the sleeve.

Abstract: A braided stent having a plurality of retrieval and/or repositioning levers includes a stent body formed of a plurality of wires interbraided in a braided pattern. The repositioning and/or retrieval levers have a loop portion extending radially away from the stent body and first and second legs extending along the stent body. The levers are configured to be actuated radially inward toward the central longitudinal axis of the stent by a radially inwardly directed force to radially collapse the stent.

Abstract: Apparatus and methods are provided for flaring a stent deployed within a branch vessel including an ostium communicating with a main vessel, a first end of the stent extending at least partially from the branch. A catheter is provided that includes a balloon having a reinforced region adjacent an unreinforced region. When the balloon is positioned at a desired location, e.g., within a stent, prosthetic valve, or other tubular prosthesis, the balloon may be inflated to a first pressure causing the reinforced and unreinforced regions to expand substantially simultaneously. Upon inflation of the balloon beyond the first pressure, the reinforced region of the balloon remains at the first diameter and the unreinforced region continues to expand, e.g., to flare one or more ends of the prosthesis.

Abstract: Delivery systems and methods for deploying an implantable device are disclosed, which can include a delivery device having an outer tubular member and an inner assembly. The inner assembly is disposed within and is slidably movable relative to the outer tubular member. The inner assembly can include a pusher at a distal portion. The pusher abuts and restricts proximal movement, relative to the inner assembly, of a crimped implantable device within the outer tubular member. The pusher can include a slot to accommodate a suture binding mechanism of the implantable device. The delivery device can include a tip disposed at a distal end. The tip includes a tip transition zone. The inner sheath and outer tubular member can each have sections of distinct rigidity along their lengths with transition zones between the sections. A transition zone of the outer tubular member and a transition zone of the inner sheath can be longitudinally offset.

Abstract: A medical device includes a polymer scaffold crimped to a catheter having an expansion balloon. A sheath pair is placed over the crimped scaffold after crimping to reduce recoil of the crimped polymer scaffold and maintain scaffold-balloon engagement relied on to hold the scaffold to the balloon when the scaffold is being delivered to a target in a body. The sheath pair is removed by a health professional before placing the scaffold within the body.

Abstract: Valve assemblies for use with expandable devices that are positioned within remote cavities and more particularly relates to the catheters/conduits used to inflate these devices with fluid.

Abstract: An intragastric device comprising: an inflation magnet provided within a capsule and configured to move towards a first end of a capsule during activation of the intragastric device by applying a magnetic field externally to a user after swallowing the intragastric device; a first chamber and a second chamber physically separated by a partition having a through hole; a separator connected to the inflation magnet and sealing the through hole before activation of the intragastric device, wherein activation of the intragastric device moves the separator to unseal the through hole to allow a chemical reaction between a first chemical stored in the first chamber and a second chemical stored in the second chamber; a balloon secured to the capsule and collapsed against the capsule before activation of the intragastric device; and an expandable volume configured to expand when the balloon is inflated by a gaseous product of the chemical reaction.

Abstract: A gastrointestinal assembly may be deployed within a patient's gastrointestinal tract in order to facilitate drainage of an abscess. The gastrointestinal assembly may include an outer stent and an inner stent disposed within the outer stent. The inner stent divides a volume within the outer stent into a primary passageway through which nutritional contents may pass and a secondary passageway protected from nutritional contents and configured to accommodate a passive drainage system for draining the abscess.

Abstract: One or more medical devices may be provided that may be used, for example, in bariatric surgery including a vertical sleeve gastrectomy. The one or more medical devices may include a laparoscopic sleeve gastrectomy stapling guide in conjunction with a calibration tube in accordance with one or more examples. According to an example, the calibration tube may be a flared, multi-diameter calibration tube. The flared, multi-diameter calibration tube may have a first diameter along a portion of the tube and a second diameter that may larger than the first diameter along at least another portion of the tube. The calibration tube may be used in conjunction with the stapling guide to align stomach such that it may be stapled along the stapling guide (e.g., to perform the vertical sleeve gastrectomy).

Abstract: A method for manufacturing a custom wearable medical device, such as an orthosis (e.g., an ankle brace, etc.), includes use of scanning processes. A digital model of a surface may be generated from data corresponding to a body part for which the customer wearable medical device is to be fabricated, and then applied to a digital device model to define a custom digital device model. The digital device model and, thus, the custom digital device model may include one or more standard features. The custom digital device model may be used with an automated manufacturing process to make some or all of the custom wearable medical device. In some embodiments, additive manufacturing processes may be used to form a portion or all of the custom wearable medical device.