Abstract: An apparatus for early detection of sepsis in a host is disclosed. The apparatus includes a first sensor to directly measure a glucose level, a second sensor to directly measure a lactate level and a third sensor to directly measure a tissue oxygen level. The first sensor, the second sensor, and the third sensor all being inserted at a single point of entry in a subcutaneous space of the host such that a predetermined correlation between the glucose level, lactate level, and tissue oxygen level signals conditions related to sepsis.

Abstract: Alignment guide systems, fixation guide devices, and methods for positioning and inserting an intramedullary nail are disclosed. The alignment guide system includes a targeting guide with a first end and a second end, an alignment wire rotatably engaging a second end of the targeting guide, and a guide sleeve insert engaging an opening in the first end of the targeting guide. The fixation guide device including a frame including a first end and a second end, a compression device slidingly coupled to the first end of the frame, and the intramedullary nail secured to a nail attachment apparatus of the frame. A method of inserting an intramedullary nail into two bones for fixation of the two bones is also disclosed.

Abstract: Devices and methods for aligning the components of polyaxial screws are described herein. In one embodiment, an alignment instrument includes an elongate frame having a longitudinal axis and a plurality of connection caps slidably disposed along the elongate frame. Each connection cap can removably couple to a polyaxial screw extension tube and selectively lock relative to the elongate frame such that a distance between the plurality of connection caps and an angular orientation of each connection cap relative to the elongate frame is maintained. The instrument can also include a transverse angle indicator to indicate an angular orientation of the elongate frame in a plane transverse to the longitudinal axis of the elongate frame. The device can, for example, capture the orientation of a plurality of polyaxial screws during spinal surgery such that the screws can be returned to the same orientation after manipulation to correct a spinal deformity, etc.

Abstract: A surgical instrument (1) for knee balancing, comprising: a static tibial element (2) including a base and a tibial paddle (21); a femoral element (3) including a femoral paddle (31) and a femoral arm; a movable element (4) including a guide (40) movable in translation on the base according to a longitudinal axis (AL), wherein the femoral element is pivotally mounted on said movable element according to an anterior-posterior axis (AP), and a transverse arm; a system (5) for setting the mobility of said guide in order to provide a distraction function; a reversible blocking system coupled between the transverse arm and the femoral arm to pivotally immobilize the femoral element with respect to the movable element in a reversible manner in order to set the pivot angle of the femoral paddle with respect to the tibial paddle at different angle values.

Abstract: A guide and a method for locating a cutting block on a resected distal surface of a patient's femur in a knee replacement procedure. The guide includes a first body part for positioning over the resected distal surface. The first body part includes a pair of posteriorly extending feet for engaging with the posterior condyles of the femur. The guide also includes a second body part for positioning over the resected distal surface. The second body part includes at least one pair of locator holes for locating fastener pins by which the cutting block can be fastened to the resected distal face. The first body part is removably attachable to the second body part in a plurality of discrete positions for selectively angling the second body part with respect to an anatomical feature of the patient when the feet of the first body part are engaged with the posterior condyles.

Abstract: An orthopaedic surgical instrument for use in resecting a patient's bone is disclosed. In some embodiments, the instrument may be for single patient use and may be disposed of at the end of each surgical procedure.

Abstract: Laparoscopic instruments and methods of use are disclosed for measuring the distance between first and second portions of a target within a patient. The device includes a shaft, a ball, and a measuring member. The shaft has a distal end configured to extend into the patient. The ball is flexibly connected to the measuring member and configured for relative movement towards and away from the distal end of the shaft. The measuring member is slidable with respect to the shaft in response to relative movement between the ball and the distal end of the shaft and includes indicia thereon, whereupon a portion of the measuring member extends out of shaft so that the indicia provides an indication of the distance between the first and second portions of the target. One embodiment of the device is spring biased to automatically retract the ball after a measurement.

Abstract: An orthopedic measurement system is disclosed to measure leg alignment. The measurement system includes a tri-axial gyroscope configured to measure movement of a leg. The gyroscope is coupled to a tibia of the leg. For example, the gyroscope can be placed in an insert or tibial prosthetic component that couples to the tibia. The gyroscope is used to measure alignment relative to the mechanical axis of the leg. The leg alignment measurement is performed by putting the leg through a first leg movement and a second leg movement. The gyroscope outputs angular velocities on the axes the sensor is rotated about. The gyroscope is coupled to a computer that calculates the alignment of the leg relative to the mechanical axis from the gyroscope measurement data.

Abstract: Holographic image-guidance can be used to track an interventional device during an endovascular percutaneous procedure. The holographic image guidance can be provided by a head-mounted device by transforming tracking data and vasculature image data to a common coordinate system and creating a holographic display relative to a patient's vasculature to track the interventional device during the endovascular percutaneous procedure. The holographic display can also include graphics to provide guidance for the physical interventional device as it travels through the patient's anatomy (e.g., the vasculature).

Abstract: Devices and methods for use in a hip replacement surgical procedure. One aspect includes methods and devices for reaming selective regions of the femoral canal. This may include reaming distal and proximal sections of the femoral canal prior to reaming a middle region of the canal. Another aspect includes a dummy implant and methods of use. The dummy implant is inserted into the femoral canal and may be used for one or more of retraction of the femur, gauging a space with the acetabulum, and further revising the femoral cut. The aspects may be used together in a single surgical procedure or separately in different surgical procedures.

Abstract: A knee gap tensioning apparatus includes: a gap tensioner including: a baseplate; a top plate; a linkage interconnecting the baseplate and the top plate and operable to move the gap tensioner between retracted and extended positions; and wherein the top plate is pivotally connected to the linkage so as to be able to freely pivot about a pivot axis.

Abstract: An adjustable device for identifying the target location for, and placement of, a bone tunnel wherein the device is capable of measuring a total distance across a region of an anatomic structure. The device may be further configured to engage the anatomic structure at a target distance across the anatomic structure to identify the location for bone tunnel placement. A method for identifying the target location for, and placement of, a bone tunnel such that the method is capable of measuring a total distance across a region of an anatomic structure and capable of engaging the anatomic structure at a target distance across the anatomic structure.

Abstract: The present invention relates to devices and methods for balancing joints, including knee joints. The devices convert unequal forces at a joint to a rotation or displacement of a pointer or gauge. The devices are able to display the relative difference in force between the lateral and medial sides of a joint from flexion to extension. In certain aspects, the devices are useful for balancing the knee during total knee surgery. The devices can be inserted between the trial femoral and tibial components of the knee and measures whether one condyle experiences more force than the other.

Abstract: Disclosed is a resection guide, a trial knee joint implant, and a surgical instrument for knee arthroplasty. The resection guide, the trial knee joint implant, and the surgical instrument enable implantation of an implant that provides improved vertical fixing force and initial fixing force as compared with an existing cementless or uncemented implant.

Abstract: A method for imparting tension across a human knee joint which includes a femur bone, a tibia bone, a patella bone, a patellar tendon, and ligaments, wherein the ligaments and patellar tendon are under anatomical tension to connect the femur and tibia together, creating a load-bearing articulating joint. The method includes: providing a tensioning device, including: a baseplate; a top plate; and a linkage interconnecting the baseplate and the top plate and operable to move the tensioning device between retracted and extended positions, wherein the top plate is pivotally connected to the linkage so as to be able to freely pivot about a pivot axis; positioning the tensioning device between the femur and the tibia; applying an actuating force to the linkage to move the tensioning device towards the extended position, so as to impart a controlled separating force driving the femur and tibia apart to extend the ligaments.

Abstract: A hinge knee system includes a tibial assembly having a baseplate component and an axle component. The baseplate component has an opening that extends therein from a proximal end toward a distal end thereof. The axle component has a shaft portion receivable within the opening of the baseplate component and an axle connected to the shaft portion that extends in a direction transverse to a longitudinal axis of the shaft portion. The system also includes a femoral assembly that includes a distal femoral component. The distal femoral component includes condylar portions and an intercondylar portion disposed between the condylar portions. The intercondylar portion includes a bearing surface that defines a recess configured to rotatably receive the axle for articulation therewith.

Abstract: A method of percutaneous implantation of a pedicle screw system comprising the steps of implanting a first pedicle screw assembly in a first vertebra, the first pedicle screw assembly including a first coupling element connected with a first extension defining a first space and implanting a second pedicle screw assembly in a second vertebra, the second pedicle screw assembly including a second coupling element connected with a second extension and intersecting at least one a portion of the second extension with the first space.

Abstract: A system for performing osteochondral transplantation surgery includes a harvesting guide tool for harvesting one or more osteochondral plugs and a transfer guide tool for insertion of each osteochondral plug in a damage site on an articular surface of a joint. A cartilage contact surface of each respective guide tool is adapted to follow the shape of a surface of cartilage or subchondral bone such that they conform to each other. Each respective guide tool includes one or more guide channels adapted to receive a respective surgical tool that slides within the guide channel, and is supported by the guide channel during surgery. The guide channels are configured to harvest and insert a plurality of osteochondral plugs of different sizes. The interiors of the guide channels are provided with markings for marking a rotational position of harvested plugs enabling positioning of the osteochondral plugs at a predetermined angle of rotation.

Abstract: The present disclosure provides dynamic cranial fixation devices and related methods for attaching a resected bone portion(s), or a bone flap, to the skull in such a manner that allows for brain swelling to occur with minimal constraint following a craniotomy or craniectomy. The present disclosure provides dynamic cranial fixation devices and related methods that provide outward movement of the bone flap as the brain swells underneath the bone flap to prevent or reduce a rise in the intracranial pressure. Once the brain swelling resolves, the dynamic cranial fixation devices and related methods of the present disclosure allow the bone flap to return to its original position (before resection) without further surgery, implantation or the like. Once the bone flap return to its original position (or substantially similar position), the bone flap may fuse with the neighboring bone(s), potentially with the assistance of one or more fusion aid.

Abstract: A stemless humeral component for replacing the humeral head of a patient's humerus includes a support flange having a number of cantilevered legs extending distally away from a bottom surface thereof. Instruments and methods for surgically installing the stemless humeral component are also disclosed.

Abstract: The invention relates to an elongated pin (2) for an external modular fixation system for temporary and/or permanent fixation applications to treat bone fractures and to connect two or more bone fragments to each other, comprising an elongated stem (3) extending along a longitudinal axis with a first end portion (4) and an opposite second end portion (5), said first end portion (4) having a tip for the insertion of the first end portion (4) into a bone, wherein said first end portion (4) has a conical shape with an external thread, forming a conical threaded end portion, the extension of said conical threaded end portion along the longitudinal axis being determined by the depth of penetration of the conical end portion limited to only the cortical portion of the bone.

Abstract: The present invention relates to a multi-tool or multi-purpose device comprising a counter sink and a depth gauge. In one aspect, the invention provides a method of determining the necessary length of a screw to be implanted into bone. Also provided herein are sterile kits comprising single-use instrumentation for use in orthopedic procedures.

Abstract: A device for measuring femur bone displacement during total hip arthroplasty includes a base element immovably mounted to the pelvis and a measurement arm, detachably mounted to the base element via a support, and the measurement arm is fitted with a microprocessor computing system with a display screen. The measurement arm includes at least two movable links, serially connected with each other and with support by rotary joints with at least one (and preferably three) degrees of freedom, whereby both movable links are fitted with an accelerometer (preferably a three-axis accelerometer) and/or a magnetic field sensor and/or a gyroscope, preferably forming together an integrated acceleration, magnetic field and gyroscopic sensor unit.

Abstract: An assembly includes a flexible fixation member, a suture, and a delivery device. The fixation member includes a body with two terminal ends. A suture passes through the flexible fixation member at various points along a length of the body such that portions of the fixation member are slidable relative to the suture and configurable to form a cluster within a surgical site. The delivery device includes a tubular member, an elongated inserter, and a trigger. The elongated inserter is slidably disposed within the tubular member. The inserter has a forked distal end configured to receive a portion of the flexible fixation member and the suture. The trigger is finger-engagable and fixedly coupled to the proximal end of the inserter. It is configured to advance and retract the inserter relative to the tubular member. The trigger includes a retention member for retaining a proximal end portion of the suture.

Abstract: A modular femoral prosthesis for use during performance of a hip revision procedure includes a proximal body component, a distal stem component, and a locking bolt. Surgical instruments and methods for use in implanting such a modular femoral prosthesis are disclosed.

Abstract: A surgical device is presented that combines multiple components and functions, such as, joint distraction, soft tissue distraction, a separation force that exerts a uniform tension on the knee ligaments, pre-aligned cut guides, and posterior cut guards that protect the posterior knee joint from unintentional damage by the surgical saw. A method of performing a partial knee replacement is also presented.

Abstract: A surgical aid for joints which allows the positioning of mono-compartment or three-compartment prosthetic components so that the isometry of the capsular-ligament tissues of the knee is maintained during the entire range of motion.

Abstract: A tray includes a plurality of rows, each of which includes a plurality of slots. Each row contains a plurality of screws. Different rows may contain screws of different types, e.g., lengths. Each of one or more rows contains a machine-readable object (e.g., peg) containing data representing properties of the objects in the corresponding rows. Removal of an object from a row is performed by reading data from the machine-readable object in the row and using that data to modify (e.g., decrement or increment) a count of the type of object contained in that row.

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: An orthopedic anchoring system for attaching a spinal stabilization system and concomitantly fusing a sacroiliac joint is disclosed that includes a delivery tool and an implant assembly for insertion into a joint space of a sacroiliac joint. The implant assembly may be secured using anchors inserted through bores within the implant body and into the underlying sacrum and/or ilium. The implant body may also include an attachment fitting reversibly attached to a guide to provide attachment fittings for elements of the spinal stabilization system. The implant assembly may be releasably coupled to an implant arm of the delivery tool such that the implant arm is substantially aligned with the insertion element of the implant assembly. An anchor arm used to insert the anchor may be coupled to the implant arm in a fixed and nonadjustable arrangement such that the anchor is generally aligned with a bore within the implant assembly.

Abstract: A method according to one embodiment includes locating distal lateral and medial condyles and posterior lateral and medial condyles a femoral bone model, and determining a posterior resection plane based on locations of the distal lateral and medial condyles, one or more dimensions of a prospective femoral implant, and one or more surgical preferences. The method may further include determining a first distance between the posterior medial condyle and the posterior resection plane and a second distance between the posterior lateral condyle and the posterior resection plane, determining a difference between a target value and an average of the first distance and the second distance, wherein the target value is associated with a thickness of the prospective femoral implant, and selecting a desired femoral implant size based on the difference between the target value and the average determined for each of a plurality of possible femoral implant sizes.

Abstract: A technique for accessing extra articular lesions or abnormalities or intra osseous lesions or abnormalities or bone marrow lesions or all has the step of positioning the localizing pinning member onto cartilage or subchondral bone to define a virtual pathway through the cartilage or subchondral bone towards or into or through the lesion or abnormality or a desired target to create the virtual pathway utilizing an intra articular localizing pinning member to determine a location of the lesion or abnormality wherein the utilization of the localizing pinning member includes the step to locate or stabilize or both and thereafter using the virtual pathway to create an entry access.

Abstract: A method and system for determining the orientation of a surgical tool with respect to a bone of a patient are disclosed. The method includes defining a bone reference plane using a processor; receiving first information at the processor from a first active sensor attached to the bone at a location having a predetermined relationship with the plane, the first information relating to a movement of the first sensor and wherein changes in orientation to the plane are trackable through changes in orientation of the first sensor; receiving second information from a second active sensor attached to the surgical tool, the second information relating to a movement of the second sensor; and determining a three-dimensional orientation of the surgical tool with respect to the plane based on the first and second information. The reference plane may be defined from distances between at least three predetermined reference locations on the bone.

Abstract: An alignment tool (2) for a joint is provided comprising a reference member 4 that defines a reference plane R and a distraction member (6). The distraction member (6) comprises first and second distraction arms (70, 72), each of which is independently moveable with respect to the reference member (4) along a movement axis M. The movement axes M, M of the first and second distraction arms (70, 72) are substantially parallel. A kit of parts is also provided comprising an alignment tool (2), a drill guide (200) and a cutting guide (300).

Abstract: A computer-readable recording medium having stored herein a program for causing a computer to execute a dental prosthesis design process includes: searching a database storing data including structures of teeth including natural teeth to search for candidate teeth, which correspond to a part where a prosthesis is to be mounted on, based on information of a shape surrounding the part where the prosthesis is to be mounted on; putting priority levels on the candidate teeth by applying a predetermined rule to a matching degree of the searching; and outputting information of the candidate teeth based on the priority levels.

Abstract: A trial system for determining a suitable proximal body implant for hip replacement surgery comprises a separator instrument, a trial body attachable to a distal stem, and an insert. The insert is positioned within the trial body to receive the separator instrument. As the separator instrument is rotated about its axis, a ramp element of the insert guides a pin of the separator instrument, so as to separate the trial body from the distal stem. Additional apparatus, methods, and systems are disclosed.

Abstract: A cutting guide for guiding a cut in a radius, the radius being adjacent to an ulna, the cutting guide comprising: a cut guiding portion, an opposed ulnar mounting portion and a linking portion extending therebetween; the cutting guide being delimited by a cutting guide peripheral surface defining a bone facing portion, the bone facing portion being contoured to match the shape of the radius and ulna.

Abstract: A computer-implemented method determines an orientation parameter value of a prosthetic component. The method includes receiving a first desired separation distance between a tibial prosthetic component and a femoral prosthetic component at a first flexion position of a knee joint and estimating a first estimated separation distance between the tibial prosthetic component and the femoral prosthetic component at the first flexion position of the knee joint for at least one potential orientation of the femoral prosthetic component. The method also includes determining a first orientation parameter value of the femoral prosthetic component by comparing the first estimated separation distance to the first desired separation distance and outputting the first orientation parameter value via a user interface.

Abstract: Instrumentation and methods are provided for knee arthroplasty which permit rotation of a distal femoral component in the sagittal plane. A guide provides for determination of both a femoral component size and rotation angle at which to install the implant in any specific patient.

Abstract: Intramedullary nails, systems, and methods. The intramedullary nail may include a generally elongate body extending from a first, distal end to a second, proximal end. The distal end may include one or more openings configured to receive one or more bone anchors that extend transversely through the distal end intramedullary nail, and thereby configured to secure the distal end of the nail. The proximal end may also include one or more openings configured to receive one or more bone anchors that extend transversely through the proximal end of the intramedullary nail, and thereby configured to secure the proximal end of the nail. In some embodiments, the proximal end may further include a cross-locking feature, which includes a second bone anchor that interlocks with a first bone anchor, for example, for enhanced bone purchase and bony fixation.

Abstract: A retractor includes a first arm, a second arm, and a translating member. The first arm comprises a proximal portion configured to retain a first retractor member and a distal portion configured to rotate relative to the proximal portion about a first axis. The second arm is configured to retain a second retractor member, such that rotation of the distal portion about the first axis causes the first retractor member to pivot toward or away from the second retractor member when the first retractor member and the second retractor member are coupled to the first arm and the second arm, respectively. The translating member is coupled between the proximal portion and the distal portion, and is configured to receive a drive force that causes the translating member to bias the distal portion to pivot relative to the proximal portion about the first axis.

Abstract: Systems, kits, and methods are provided that may be used to assess a prosthetic gap in a resected joint, including an angular alignment of the resected bone surfaces in the joint. A system can comprise a reference spacer assembly comprising a spacer body with an elongated handle and one or two reference spacer plates. A kit can comprise a plurality of spacer bodies and reference spacer plates that can be selected and assembled by an operator to modularly produce assembled reference spacer devices having a range of different configurations. Methods for assessing a prosthetic gap, including a prosthetic gap dimension, a prosthetic gap symmetry, a tibial resection posterior slope, and a distal femoral resection angle, are also provided.

Abstract: An elliptical, optical-tracking marker comprises an inner marker body that is filled with radially spread color spectrum points with respect to a center point of the inner marker body. A color value of each spectrum point of the inner marker body is calculated as a function of an angle defined between a horizontal line crossing the central point of the inner marker body and a line crossing the central point of the inner marker as well as the given pixel in such a manner, that the color values of the respective spectrum points vary in accordance with a sinusoidal pattern along an elliptical path around the center point, in particular along a circular path centered around the center point. A method and a system for determining a 3D position of an object in space use the characteristics of this marker by detecting and analyzing the sinusoidal pattern.

Abstract: A thickness gage including a transparent measurement tube configured to receive and be slidingly engaged over a tubular shaft of a retrograde reamer. The tubular shaft has linear graduation marks on its surface for identifying linear measures for use in measuring a thickness of a bridge bone gap. The linear graduation marks are located on the tubular shaft surface such that at least some of the linear graduation marks can be observed through the transparent measurement tube. Each linear graduation mark, when aligned with a proximal end of the measurement tube, provides a linear measure of the distance between a distal end of the measurement tube and a cutting member of the retrograde reamer positioned so that its central axis is disposed at a non-zero angle relative to a longitudinal axis of the tubular shaft. Such a distance corresponds to the thickness of the bridge bone gap.

Abstract: A joint balancing insert with an actuated mechanism is for balancing a joint during a joint surgery is disclosed. The joint balancing insert includes a first plate, a second plate and an actuator there between. The second plate includes an integrated mounting portion for mounting a cutting block used to guide surgical cuts of the joint during the joint surgery. Various configurations of the integrated mounting portion may be implemented in the insert to provide for mounting various types of cutting blocks, such as cutting blocks for tibial cuts, femoral cuts, and distal femoral cuts.

Abstract: Devices, kits, and methods that may be used to establish a distal femoral resection position or a proximal tibial resection position and a prosthetic gap in a total knee arthroplasty procedure are provided. Devices for establishing a distal femoral resection position or a proximal tibial resection position may comprise a support that attaches to and references a proximal resected tibia or distal resected femur and supports and establishes the position of a resection guide. A kit may comprise a device for establishing a distal femoral resection position or proximal tibial resection position and additional components that complement the device or facilitate application of the device during a total knee arthroplasty procedure. Methods for establishing a distal femoral resection position or a proximal tibial resection position are also provided.

Abstract: One variation of a method for augmenting a surgical field with virtual guidance content includes: accessing a scan representing a tissue of a patient; combining the scan with a generic virtual anatomical model to define a custom virtual anatomical model of the tissue; defining a cut trajectory along an intersection between a virtual model of a surgical implant and the custom virtual anatomical model of the tissue; aligning a virtual cut surface to the cut trajectory to locate the virtual model of the surgical guide relative to the custom virtual anatomical model; accessing an image of a surgical field; detecting the tissue in the image; aligning the custom virtual anatomical model to the tissue detected in the image; defining a target real location for a real surgical guide in the surgical field; and generating a frame depicting the target real location of the surgical guide in the surgical field.

Abstract: The present disclosure provides a provisional tibial prosthesis system for a set of prosthetic knee joints for implantation in a natural knee, the provisional tibial prosthesis system including a bearing component and a bearing support, the spacing of the bearing component from the bearing support is adjustable to allow for representation of a variety of different sized final tibial prostheses. In this system, only one provisional bearing component corresponding to each level of constraint is needed and shims are used to adjust the spacing of the bearing component from the beating support. The shims are slidably insertable between the bearing component and the bearing support in an anterior/posterior direction to allow for adjustment of the spacing of the bearing component from the bearing support. The number of provisional components needed during knee surgery is reduced and adjustment of the system only requires the knee joint to be distracted by a distance equal to the height of a particular shim.

Abstract: Embodiments of the invention include a system and method for coupling a graft to a bone. A graft preparation tool may be used to place one or more holes in a graft and an offset measurement tool may be used to determine the distance of the one or more holes from an edge of the graft to be aligned with a portion of the bone. One or more complementary holes may then be created in the bone and fasteners applied through the holes to couple the graft to the bone.

Abstract: Systems, devices, and methods are provided for measuring forces in the space of a knee during surgery. Such forces can be caused by tension in the ligaments of the knee. A femoral member is engaged with a distal femur. While the knee is flexed, partially extended, or fully extended, a force sensor and a gauge shim can be placed in the gap between the femoral member and the tibial plateau to measure the forces therebetween. The force sensor provides an accurate and quantifiable measurement of force, making knee replacement surgery and ligament tension balancing more accurate, standardized and repeatable. The force sensor comprises an elongate housing which comprises a thin force sensing distal portion and a proximal handle portion.