External fixator for distal radius fracture

Abstract

An external fixator for a fractured distal radius including a first plurality of vertical passages for pins extending downward from a first pin mounting block into one or more bone fragments and one or more frame element apertures extending from an elongated frame element for pins extending downward from the device into the shaft of the radius.

Description

PCT / US25 / 32413 05 June 2025 (05.06.2025)Nutek-0017 PCTEXTERNAL FIXATOR FOR DISTAL RADIUS FRACTUREPRIORITYThis application claims priority to U.S. Provisional Patent Application Serial No. 63 / 658,0355 filed June 10, 2024, the contents of which are hereby incorporated by reference in its entirety.FIELD OF THE INVENTION

[0001] The present invention relates to devices for external fixation of fractured bones, and / or bone fragments.10BACKGROUND

[0002] The fracture of the distal radius is one of the most common human fractures , occurring in as many as 350,000 people per year in the United States alone. Conventional processes for maintaining bones in proper alignment during the subsequent healing process involves applying and maintaining an extension force across the fracture, with ligamental taxis being relied upon to hold the bones in place. The process for treating a fractured distal radius is described in the 1901 edition of Gray’s Anatomy in the following manner, “The treatment consists of flexing the forearm, and making a powerful extension from the wrist and elbow, depressing at the same time the radius side of the hand, and retaining the parts in that position20 by well -padded pistol-shaped splints.”

[0003] A common method for the treatment of a fractured distal radium involves the use of standard immobilizing case techniques, preventing movement of the radiocarpal joint throughout the course of rehabilitation. A problem with this method is that it sometimes results in inadequate internal fixation, which can cause deformity, pain, and disability.25

[0004] Another method for treating a fractured distal radius involves external pin fixation. This process involves the surgical insertion of skeletal traction pins on both sides of the fracture, with a frame being connected to the pins for immobilizing the bones, and for holding them together until the fracture is mended. Initial structures and methods for applying external pin fixation for the treatment of a fractured distal radius provide for the immobilization of the radiocarpal joint, so that the hand cannot be flexed. While this type of fixation often provides an improvement over conventional casting techniques in the management of severe fractures of the distal radius, immobilization of the radiocarpal joint during the treatment period typically results in a long period of stiffness and disability after the external fixation devices is removed. Typically, the external fixation device is left in place during the healing process for six to eight35 weeks. After the fixation device is removed, three to six months are required for the patient toPCT / US25 / 32413 05 June 2025 (05.06.2025) regain motion of his hand.

[0005] Subsequent structures and methods have been developed to provide adequate fixation during the healing process while allowing flexure in the radiocarpal joint. Using these newer structures and methods, patients have been able to gain immediate use of the joint after surgery.5

[0006] An example of a fixation device and fixation method that provides adequate fixation and allows flexure in the radiocarpal joint is described in U.S. Pat. No. 6,585,736, the disclosure of which is incorporated herein by reference. U.S. Pat. No. 6,585,736, describes a fixation that is configured to provide external fixation of a fractured distal radium by including a first10 number of holes for pins extending downward from the fixture into one or more fragments, rods that extend downward and hold pins laterally into one or more bone fragments, and a second number of holes for pins extending downward from the fixture into the shank of the radius. The fixture also include a sliding block through which rods extend to hold pins directed laterally into the fragments. A sliding plate including a number of holes aligned with the first number of holes is moved by a pair of setscrews to clamp the pins extending through the first number of holes. The second number of holes include a hole within a sliding structure allowing a single pin to be moved with a fixture to provide extension between the fragments and the shank of the radius.

[0007] In a more recent fixation device described in U.S. Pat. No. 8,075,560, the disclosure of which is incorporated herein by reference, external fixation of a fractured distal radium is achieved by (i) a first pin mounting block having parallel, vertically-extending apertures therein for pins extending vertically downward from the first pin mounting block, at a fixed 90° angle to the first pin mounting block, into one or more bone fragments, and (ii) a second pin mounting block extending perpendicular to the first pin mounting block, and having horizontally¬25 extending apertures therein for pins extending laterally into one or more bone fragments.

[0008] Efforts continue to further develop fixation devices that provide one or more benefits over known fixation devices. What is needed is more functionally effective structure that provide enhanced orientation of pins extending vertically and horizontally from the fixation devices. Such a structure and method would still allow mobility of the hand and wrist while presenting fewer surfaces to get caught on other objects and being more cost effective due to it having parts.SUMMARY OF THE INVENTION

[0009] The present invention is directed to external fixators comprising a fixator body,35 wherein the fixator body has an elongated frame element at one end and a first pin mountingPCT / US25 / 32413 05 June 2025 (05.06.2025) block at the opposite end. A second pin mounting block is orthogonally connected to one side of the fixator body. The external fixator provides a more stable structure to fix a plurality of fragments (or segments) of a fractured distal radius bone with respect to the radius bone shaft.

[0010] The fixator body comprises the elongated frame element at one end and the first pin5 mounting block at the opposite end of the fixator body. The fixator body is externally attached to the distal radium bone by one or more mounting bone pins housed within the elongated frame, both screwed and locked into the radius bone shaft, above the radius bone and the wrist. The fixator body is thus mounted parallel to the radium bone and above the radius bone extending over the wrist area of the patient.10

[0011] In some embodiments, the external fixators of the present invention comprise a fixator body that comprises (a) a first pin mounting block extending along an upper surface at a front end of the fixator body, (b) an elongated frame element extending from the first pin mounting block along the upper surface to a rear end of the fixator body, and (c) a plurality of mounting block apertures extending through the first pin mounting block from upper surface to a lower surface of the fixator body, each mounting block aperture comprising (i) a mounting block aperture inlet along the upper surface, (ii) a mounting block aperture outlet along the lower surface, and (iii) a mounting block aperture inner side surface extending between the mounting block aperture inlet and the mounting block aperture outlet, wherein the mounting block aperture outlet has a cross-sectional area AAOMB that is smaller than a cross-sectional area AAIMB of the mounting block aperture inlet. Each mounting block aperture is designed to allow a given vertically-extending fragment pin, used to fix bone chips in place, to be (1) angularly disposed at an acute angle of up to about thirty degrees (30°) from a normal line N perpendicular to the first pin mounting block, (2) screwed into a bone fragment, and (3) locked into place along the first pin mounting block by tightening a channel-containing clamping25 component onto a spherical pin holder containing the vertically-extending fragment pin.

[0012] In some embodiments, the external fixators of the present invention comprise a fixator body that comprises (a) a first pin mounting block extending along an upper surface at a front end of the fixator body, (b) an elongated frame element extending from the first pin mounting block along the upper surface to a rear end of the fixator body, and (c) a plurality of mounting block apertures extending through the first pin mounting block from upper surface to a lower surface of the fixator body, each mounting block aperture comprising (i) a mounting block aperture inlet along the upper surface, (ii) a mounting block aperture outlet along the lower surface, and (iii) a mounting block aperture inner side surface extending between the mounting block aperture inlet and the mounting block aperture outlet, wherein each first pin mounting35 block aperture is designed to allow a given vertically-extending fragment pin, positionedPCT / US25 / 32413 05 June 2025 (05.06.2025) therein, to be angularly disposed at an acute angle of greater than 0 up to about thirty degrees (30°) from a normal line N perpendicular to the first pin mounting block.

[0013] In some embodiments, the external fixators of the present invention comprise a second pin mounting block that is attachable to the fixator body along a side edge of the first5 pin mounting block, and comprises a plurality of second pin mounting block apertures extending through the second pin mounting block from a front surface to a rear surface of the second pin mounting block, wherein each second pin mounting block aperture comprises (i) a second pin mounting block aperture inlet along the front surface, (ii) a second pin mounting block aperture outlet along the rear surface, and (iii) a second pin mounting block aperture10 inner side surface extending between the second pin mounting block aperture inlet and the second pin mounting block aperture outlet, wherein the second pin mounting block aperture outlet has a cross-sectional area AAOSMB that is smaller than a cross-sectional area AAISMB of the second pin mounting block aperture inlet. Each second pin mounting block aperture is designed to allow a given horizontally-extending fragment pin, used to fix bone chips in place, to be (1) angularly disposed at an acute angle of up to about thirty degrees (30°) from a normal line N perpendicular to the second pin mounting block, (2) screwed into a bone fragment, and (3) locked into place along the second pin mounting block by tightening a channel-containing clamping component onto a spherical pin holder containing the horizontally-extending fragment pin.

[0014] Because of the location of the first pin mounting block and the second mounting pin block and their orthogonal relationship, as well as the angular orientation range provided by the first pin mounting block apertures, and the second pin mounting block apertures, the distal radium bone fragments can be fixed in place in multiple dimensions.

[0015] Using the external fixator devices of the present invention, for example, as an external25 fixator for a radium fracture, allows for immediate post operative wrist and finger function and motion from dorsal to volar function, radial to ulnar deviation, supination, and pronation.

[0016] The present invention is further directed to kits for forming the disclosed external fixators of the present invention. In some embodiments, the kit for forming an external fixator comprises one or more fixator bodies, at least one of which comprises a fixator body that comprises (a) a first pin mounting block extending along an upper surface at a front end of the fixator body, (b) an elongated frame element extending from the first pin mounting block along the upper surface to a rear end of the fixator body, and (c) a plurality of mounting block apertures extending through the first pin mounting block from upper surface to a lower surface of the fixator body, each mounting block aperture comprising (i) a mounting block aperture35 inlet along the upper surface, (ii) a mounting block aperture outlet along the lower surface, andPCT / US25 / 32413 05 June 2025 (05.06.2025)(in) a mounting block aperture inner side surface extending between the mounting block aperture inlet and the mounting block aperture outlet, wherein each first pin mounting block aperture is designed to allow a given vertically-extending fragment pin, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about thirty degrees (30°) from5 a normal line N perpendicular to the first pin mounting block. The kits may further comprise (i) one or more of the herein-described second pin mounting blocks, (ii) one or more of the herein-described first spherical pin holders, (iii) one or more of the herein-described second spherical pin holders, (iv) one or more of the herein-described first channel-containing clamping components, (v) one or more of the herein-described second channel-containing10 clamping components, (vi) one or more of the herein-described elongated frame element sleeves, (vii) one or more of the herein-described device spacers, (viii) one or more of the herein-described bone-engaging pins; (ix) one or more of the herein-described bolts, or (x) any combination of two or more of (i) to (ix).

[0017] The present invention is even further directed to methods of making and using the herein-disclosed external fixator device of the present invention. In some embodiments, the methods of making an external fixator comprise: forming a fixator body that comprises (a) a first pin mounting block extending along an upper surface at a front end of the fixator body, (b) an elongated frame element extending from the first pin mounting block along the upper surface to a rear end of the fixator body, and (c) a plurality of first pin mounting block apertures extending through the first pin mounting block from upper surface to a lower surface of the fixator body, each first pin mounting block aperture comprising (i) a mounting block aperture inlet along the upper surface, (ii) a mounting block aperture outlet along the lower surface, and (iii) a mounting block aperture inner side surface extending between the mounting block aperture inlet and the mounting block aperture outlet, wherein each first pin mounting block25 aperture is designed to allow a given vertically-extending fragment pin, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about thirty degrees (30°) from a normal line N perpendicular to the first pin mounting block. The methods of making an external fixator of the present invention may further comprise one or more additional steps as discussed below.

[0018] In some embodiments, the methods of using an external fixator comprise: (1) surgically implanting one or more vertically-extending fragment pins into one or more bones, the one or more vertically-extending fragment pins extending through (i) one or more first pin mounting block apertures within a first pin mounting block positioned above the one or more bones, and (ii) one or more spherical pin holders; (2) adjusting an angular orientation of one or35 more of the vertically-extending fragment pins, the angular orientation being adjustable up toPCT / US25 / 32413 05 June 2025 (05.06.2025) about 30 from a normal line N extending through the first pm mounting block; and (3) after the adjusting step, locking the vertically-extending fragment pin in a desired angular orientation via a first channel-containing clamping component. The methods of using an external fixator of the present invention may further comprise one or more additional steps as discussed below.5

[0019] These and other features and advantages of the present invention will become apparent after a review of the following detailed description of the disclosed embodiments and the appended claims.10 BRIEF DESCRIPTION OF THE DRAWINGS

[0020] The present invention is further described with reference to the appended figure, wherein:

[0021] FIG. 1 is a perspective view of an exemplary external fixator device of the present invention suitable for external fixation;15

[0022] FIG. 2 is a perspective top view of an exemplary fixator body suitable for use in the exemplary external fixator device shown in FIG. 1;

[0023] FIG. 3 is a perspective bottom view of the exemplary fixator body shown in FIG. 2;

[0024] FIG. 4 is a top view of the exemplary fixator body shown in FIG. 2;

[0025] FIG. 5 is a bottom view of the exemplary fixator body shown in FIG. 2;

[0026] FIG. 6 is a left-side view of the exemplary fixator body shown in FIG. 2;

[0027] FIG. 7 is a right-side view of the exemplary fixator body shown in FIG. 2;

[0028] FIG. 8 is a front view of the exemplary fixator body shown in FIG. 2;

[0029] FIG. 9 is a rear view of the exemplary fixator body shown in FIG. 2;

[0030] FIG. 10 is another bottom view of the fixator body shown in FIG. 2 with line 11-1125 extending along a length of the fixator body;

[0031] FIG. 11 is a cross-sectional view of the fixator body shown in FIG. 10 as viewed along line 11-11;

[0032] FIG. 12 is another bottom view of the fixator body shown in FIG. 2 with line 13-13 extending along a width of the fixator body;

[0033] FIG. 13 is a cross-sectional view of the fixator body shown in FIG. 12 as viewed along line 13-13;

[0034] FIG. 14 is a front view of the fixator body shown in FIG. 2 in combination with (i) an exemplary spherical pin holder, (ii) an exemplary vertically-extending fragment pin, and (iii) an exemplary channel-containing clamping component, all of which are suitable for use in the35 exemplary external fixator device shown in FIG. 1;PCT / US25 / 32413 05 June 2025 (05.06.2025)

[0035] FIG. 13 is a cross-sectional view of the exemplary external fixator device components shown in FIG. 1 with (i) the exemplary spherical pin holder positioned within an exemplary mounting block aperture of the exemplary fixator body and along an interior surface of the exemplary mounting block aperture, (ii) the exemplary channel-containing clamping5 component attached to the fixator body so as to capture the exemplary spherical pin holder within the exemplary mounting block aperture, and (iii) the exemplary vertically-extending fragment pin extending through the exemplary channel-containing clamping component, the exemplary spherical pin holder, and a bottom surface of the fixator body, the exemplary vertically-extending fragment pin being designed to extend within a bone of a patient (e.g., the10 wrist of a patient).

[0036] FIGS. 16A-16B depict exemplary spherical pin holders suitable for use in the exemplary external fixator device shown in FIG. 1;

[0037] FIGS. 17A-17B depict exemplary channel-containing clamping components suitable for use in the exemplary external fixator device shown in FIG. 1;

[0038] FIG. 18 depicts an exemplary elongated frame element sleeve suitable for use in the exemplary external fixator device shown in FIG. 1;

[0039] FIG. 19 depicts an exemplary device spacer suitable for use in the exemplary external fixator device shown in FIG. 1;

[0040] FIG. 20 is a perspective view of an exemplary second mounting block suitable for use in the exemplary external fixator device shown in FIG. 1;

[0041] FIG. 21 is a front view of the exemplary second mounting block shown in FIG. 20;

[0042] FIG. 22 is a rear view of the exemplary second mounting block shown in FIG. 20;

[0043] FIG. 23 is a cross-sectional view of the exemplary second mounting block shown in FIG. 21 as viewed along line 23-23;25

[0044] FIG. 24 is a cross-sectional view of the exemplary second mounting block shown in FIG. 21 as viewed along line 24-24;

[0045] FIG. 25 is a cross-sectional view of the exemplary second mounting block shown in FIG. 21 as viewed along line 25-25;

[0046] FIG. 26 is a perspective view of an exemplary bolt suitable for connecting the second mounting block shown in FIG. 20 to the exemplary fixator body shown in FIG. 2; and

[0047] FIGS. 27A-27C provide various orientations of (i) vertically-extending pins extending downward from a first pin mounting block, and (ii) horizontally-extending pins extending horizontally from a second pin mounting block, relative to one another.

[0048] The features of the present external fixator devices, individual components of the35 external fixator devices, and methods of using the external fixator devices are set forth in partPCT / US25 / 32413 05 June 2025 (05.06.2025) in the following preferred embodiments. This overview is intended to provide nonhmiting descriptions of the present subject matter and is not intended to provide an exclusive or exhaustive explanation. The preferred embodiments below provide further information about the external fixator devices, individual components of the external fixator devices, and methods5 of using the external fixator devices of the present invention as described herein.DETAILED DESCRIPTION OF THE INVENTION

[0049] The present invention is directed to external fixators that are designed for surgical attachment to two or more bones within a patient, such as the shank portion of the radius bone,10 and other bones within the wrist of a patient.

[0050] The present invention is further directed to external fixator kits comprising numerous kit components to form a customized external fixator.

[0051] The present invention is even further directed to methods of making and using external fixators and external fixator kits to position and set numerous bones of a patient into15 a set position for healing.

[0052] FIGS. 1-27C provide examples of various components that can be used to form external fixators of the present invention. As shown in FIG. 1, exemplary external fixator 100 comprises a fixator body 13 that comprises (a) a first pin mounting block 23 extending along an upper surface 131 at a front end 132 of the fixator body 13, (b) an elongated frame element 12 extending from first pin mounting block 23 along the upper surface 131 to a rear end 133 of the fixator body 13, and (c) a plurality of first pin mounting block apertures 26 extending through first pin mounting block 23 from upper surface 131 to a lower surface 135 of the fixator body 13, each first pin mounting block aperture 26 comprising (i) a mounting block aperture inlet 261 along the upper surface 131, (ii) a mounting block aperture outlet 262 along the lower25 surface 135, and (iii) a mounting block aperture inner side surface 263 extending between the mounting block aperture inlet 261 and the mounting block aperture outlet 262, wherein the mounting block aperture outlet 262 has a cross-sectional area AAOMB that is smaller than a cross-sectional area AAIMB of the mounting block aperture inlet 261.

[0053] As further shown in FIGS. 1 and 14, exemplary external fixator 100 also comprises at least the following components: (i) a second pin mounting block 43 extending perpendicular (about 90°) to and below the fixator body 13; (ii) an elongated frame element sleeve 70; (iii) a device spacer 126; (iv) first channel-containing clamping components 40; (v) second channelcontaining clamping components 40’; (vi) first spherical pin holders 39; (vii) various boneengaging pins 11 / 22 / 22’; and (viii) bolts 80. Each of these components will be described in35 further detail below.PCT / US25 / 32413 05 June 2025 (05.06.2025)

[0054] The external fixators 100 of the present invention are configured for surgical attachment to one or more bones of a patient. As shown in FIG. 1, external fixators 100 of the present invention can be used for surgical attachment to the shank portion of a radius bone 200 (and other bones and / or bone fragments) via (a) one or more vertically-extending bone pins 115 extending downward from the elongated frame element 12 of fixator body 13, with the pointed end 14 of each vertically-extending bone pin 11 being screwed into the bone 200, (b) one or more vertically-extending fragment pins 22 extending downward from the first pin mounting block 23, with the pointed end 24 of each vertically-extending fragment pin 22 being screwed into the bone 200 (or another bone and / or bone fragment), and (c) one or more horizontally -10 extending fragment pins 22’ extending horizontally from a second pin mounting block 43 (i.e., at an angle of from about 50° to about 130° relative to a direction of a given vertically- extending fragment pin 22 extending downward from the first pin mounting block 23), with the pointed end 24’ of each horizontally-extending fragment pin 22’ being screwed into the bone 200 (or another bone and / or bone fragment).

[0055] Each of the one or more vertically-extending fragment pins 22 that extend downward from the first pin mounting block 23 are fixed into place within a given first pin mounting block aperture 26 via a first spherical pin holder 39 and a first channel-containing clamping components 40 as shown, for example, in FIG. 15. A given vertically-extending fragment pin 22 is positioned thru and within a pin mounting hole 52 of a given first spherical pin holder 39, which is then positioned within a given first pin mounting block aperture 26. Once the pin 22 / pin holder 39 combination is positioned relative to bone, a first channel-containing clamping component 40 is positioned within the first pin mounting block aperture 26 so as to clamp the pin 22 / pin holder 39 combination in a “locked” (i.e., “set”) positioned / configuration within first pin mounting block aperture 26, and the first pin mounting block 23.25

[0056] Each of the one or more horizontally-extending fragment pins 22’ that extend horizontally from the second pin mounting block 43 are fixed into place within a given second pin mounting block aperture 46 via (i) a first spherical pin holder 39 (or a second spherical pin holder 39’) and (ii) a first channel-containing clamping component 40 (or a second channelcontaining clamping component 40’). A given horizontally-extending fragment pin 22’ is positioned thru and within a pin mounting hole 52 of a given first spherical pin holder 39 (or a pin mounting hole 52’ of a second spherical pin holder 39’), which is then positioned within a given second pin mounting block aperture 46. Once the pin 22 ’ / pin holder 39 / 39’ combination is positioned relative to bone, a first channel-containing clamping component 40 (or a second channel-containing clamping component 40’) is positioned within the second pin mounting35 block aperture 46 so as to clamp the 227pin holder 39 / 39’ combination in a “locked” (i.e.,PCT / US25 / 32413 05 June 2025 (05.06.2025)“set ) positioned / configuration within second pin mounting block aperture 46, and the second pin mounting block 43.

[0057] Due to the pin positioning ability of the first pin mounting block 23 and the second pin mounting block 43, pins 22 / 22’ within the first pin mounting block 23 and the second pin5 mounting block 43 can be oriented relative to one another at an angle of from about 50° to about 130°. As shown in FIGS. 15 and 23, pins 22 extending vertically from the first pin mounting block 23 and pins 22’ extending horizontally from the second pin mounting block 43 can be oriented along an arc / acute angle of about 40° (desirably, up to about 60°), or about 20° (desirably, up to about 30°) on either side of a normal line N extending through the first pin10 mounting block 23 or the second pin mounting block 43. The range of motion provided for each of pins 22 / 22’ within the first pin mounting block 23 and the second pin mounting block 43 provides a user with more flexibility with regard to positioning of pins 22 / 22’ within the first pin mounting block 23 and the second pin mounting block 43.

[0058] As shown in FIGS. 27A-27C, pins 22 / 22’ within the first pin mounting block 23 and the second pin mounting block 43 can be oriented relative to one another by any desired arc ranging from as little as 50° (desirably, as little as 30°) to as much as 130° (desirably, as much as 150°). FIG. 27A depicts pins 22 / 22’ oriented to have a 130° arc / angle (e.g., 90° + 20° + 20°) between pins 22 / 22’. FIG. 27B depicts pins 22 / 22’ oriented to have a 90° arc / angle (e.g., 90° + 20° - 20°) between pins 22 / 22’. FIG. 27C depicts pins 22 / 22’ oriented to have a 50° arc / angle (e.g., 90° - 20° - 20°) between pins 22 / 22’.

[0059] It should be further noted that each of the one or more vertically-extending bone pins 11 extending downward from the elongated frame element 12 of fixator body 13 are fixed into place within a given elongated frame element aperture 36 via (i) a first spherical pin holder 39 (or a second spherical pin holder 39’) and (ii) a first channel-containing clamping component25 40 (or a second channel-containing clamping component 40’). A given vertically-extending bone pins 11 is positioned thru and within a pin mounting hole 52 of a given first spherical pin holder 39 (or a pin mounting hole 52’ of a second spherical pin holder 39’), which is then positioned within a given elongated frame element aperture 36. Once the pin 11 / pin holder 39 / 39’ combination is positioned relative to bone, a first channel-containing clamping component 40 (or a second channel-containing clamping component 40’) is positioned within the elongated frame element aperture 36 so as to clamp the 11 / pin holder 39 / 39’ combination in a “locked” (i.e. , “set”) positioned / configuration within elongated frame element aperture 36, and the elongated frame element 12 of fixator body 13.

[0060] As shown in FIGS. 16A-16B, both first spherical pin holders 39 and second spherical35 pin holders 39’ independently comprise a pair of ball slots 51 or 51’ extending perpendicularPCT / US25 / 32413 05 June 2025 (05.06.2025) to a pm mounting hole 52 or 52 and inward across the pm mounting hole 52 or 52 and partly across the spherical pin holder 39 or 39’, so that the deformable portion 53 or 53’ is actuated between each end 54 or 54’ of the pin mounting hole 52 or 52’ and the ball slots 51 or 51’ that is nearer to the end 54 or 54’.5

[0061] Each pin mounting hole 52 or 52’ extends through a center of the spherical pin holder 39 or 39’, being divided by the ball slots 51 or 51’ into a deflectable part 55 or 55’ within each of the deformable portions 53 or 53’ and a central part 56 or 56’ extending between the ball slots 51 or 51’. When an exterior clamping component 40 or 40’ is tightened onto a given10 spherical pin holder 39 or 39’ to increase an engagement force holding the spherical pin holder 39 or 39’ in place, the deformable portions 53 or 53’ are deflected inward, bring the deflectable parts 55 or 55’ of the pin mounting hole 52 or 52’ out of alignment with the central part 56 or 56’ thereof, so that the pin 22 or 22’ is clamped in place within the pin mounting hole 52 or 52’.

[0062] As shown in FIGS. 17A-17B, exterior clamping components 40 or 40’ may comprise nut threads 49 or 49’ that can engage with corresponding threads along (i) mounting block aperture inner side surface 263, or (ii) elongated frame element aperture inner side surface 363, or (iii) second pin mounting block aperture inner side surface 463 so as to tighten exterior clamping components 40 or 40’ onto a given spherical pin holder 39 or 39’, forcing clamping contact surface 403 onto the spherical pin holder 39 or 39’, and holding the spherical pin holder 39 or 39’ in place within a given first pin mounting block aperture 26, or a given elongated frame element aperture 36, or a given second pin mounting block aperture 46.

[0063] The configuration shown in FIG. 1 is assembled particularly for treating a distal fracture of the right radius 200. For treating a distal fracture of the left radius, the second pin25 mounting block 43 is positioned along an opposite side edge 235 from that shown in FIG. 1.

[0064] One exemplary method for installing the external fixator 100 to provide both support and extension to a fractured radius 200 comprises the following steps: (1) surgically inserting a vertically-extending bone pin 11 into the shank portion of a radius bone 200, the vertically- extending bone pin 11 extending through (i) an elongated frame element aperture 36, (ii) a spherical pin holder 39 or 39’, (iii) and an elongated frame element sleeve 70; (2) surgically implanting one or more vertically-extending fragment pins 22 into one or more distal fragments of the radius bone 200, the one or more vertically-extending fragment pins 22 extending through (i) one or more first pin mounting block apertures 26, and (ii) one or more first spherical pin holders 39; (3) surgically implanting one or more horizontally-extending35 fragment pins 22’ into one or more distal fragments of the radius bone 200, the one or morePCT / US25 / 32413 05 June 2025 (05.06.2025) horizontally-extending fragment pins 22 extending through (i) one or more second pm mounting block apertures 46, and (ii) one or more second spherical pin holders 39’; (4) adjusting an angular orientation of one or more of the vertically-extending fragment pins 22, the angular orientation being adjustable up to about 30° from a normal line N extending through5 the first pin mounting block 23; and (5) after said adjusting step, locking the vertically- extending fragment pin 22 in a desired angular orientation via a first channel-containing clamping component 40. The order in which pins 11, 22, and 22’ are implanted may be arbitrary, or may be determined by surgical considerations including the exact type of fracture.

[0065] Pins 11, 22, and 22’ are preferably commercially available pins, which are10 conventionally composed of stainless steel. Other portions of the external fixator 100 are preferably composed of thermoplastic resins, with the screws being composed, for example, of nylon, and with the remaining parts being composed, for example, of polycarbonate. This use of thermoplastic material makes it possible to form X-ray images of the bones through the external fixator 100. Furthermore, such materials provide a sufficient combination of strength and resiliency to allow a range of patterns / configurations of vertically-extending fragment pins22 to be clamped simultaneously as described above.Additional EmbodimentsExternal Fixators

[0066] 1. An external fixator 100 for surgical attachment to a radius bone 200, said external fixator 100 comprising a fixator body 13 that comprises (a) a first pin mounting block23 extending along an upper surface 131 at a front end 132 of the fixator body 13, (b) an elongated frame element 12 extending from said first pin mounting block 23 along the upper surface 131 to a rear end 133 of the fixator body 13, and (c) a plurality of first pin mounting25 block apertures 26 extending through said first pin mounting block 23 from upper surface 131 to a lower surface 135 of the fixator body 13, each first pin mounting block aperture 26 comprising (i) a mounting block aperture inlet 261 along the upper surface 131, (ii) a mounting block aperture outlet 262 along the lower surface 135, and (iii) a mounting block aperture inner side surface 263 extending between the mounting block aperture inlet 261 and the mounting block aperture outlet 262, wherein the mounting block aperture outlet 262 has a cross-sectional area AAOMB that is smaller than a cross-sectional area AAIMB of the mounting block aperture inlet 261. See, exemplary fixator body 13 shown in FIGS. 2-13.

[0067] 2. The external fixator 100 of embodiment 1, wherein each first pin mounting block aperture 26 has a minimum cross-sectional area AAIMMB at the mounting block aperture35 outlet 262 or proximate the mounting block aperture outlet 262.PCT / US25 / 32413 05 June 2025 (05.06.2025)

[0068] 3. The external fixator 100 of embodiment 2, wherein the minimum cross- sectional area AAIMMB is proximate the mounting block aperture outlet 262.

[0069] 4. The external fixator 100 of embodiment 2 or 3, wherein the minimum cross- sectional area AAIMMB is smaller than the cross-sectional area AAOMB at the mounting block5 aperture outlet 262.

[0070] 5. The external fixator 100 of any one of embodiments 1 to 4, wherein each first pin mounting block aperture 26 is designed to allow a given vertically-extending fragment pin 22, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about thirty degrees (30°) from a normal line N perpendicular to the first pin mounting block 23. See,10 for example, the angular orientation of exemplary vertically-extending fragment pins 22 shown in FIGS. 1, 15, and 27A-27C.

[0071] 6. The external fixator 100 of any one of embodiments 1 to 5, wherein each first pin mounting block aperture 26 is designed to allow a given vertically-extending fragment pin 22, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about 20° from a normal line N perpendicular to the first pin mounting block 23.

[0072] 7. The external fixator 100 of any one of embodiments 1 to 6, wherein each first pin mounting block aperture 26 is sized to receive a first spherical pin holder 39 into the mounting block aperture inlet 261 so that the first spherical pin holder 39 (i) contacts and rests upon a portion 263' of the mounting block aperture inner side surface 263 proximate the mounting block aperture outlet 262, and (ii) does not exit the mounting block aperture outlet 262. See, exemplary first spherical pin holder 39 shown in FIG. 16A.

[0073] 8. The external fixator 100 of embodiment 7, wherein each first pin mounting block aperture 26 is sized to further receive a first channel-containing clamping component 40 that (i) attaches to said fixator body 13 proximate the mounting block aperture inlet 261, (ii)25 prevents the first spherical pin holder 39 from exiting a given first pin mounting block aperture 26, and (iii) provides a clamping contact surface 403 along or proximate the first spherical pin holder 39 when the first spherical pin holder 39 and the first channel-containing clamping component 40 are positioned within a given first pin mounting block aperture 26. See, exemplary first channel-containing clamping component 40 shown in FIG. 17A.

[0074] 9. The external fixator 100 of any one of embodiments 1 to 8, wherein the first pin mounting block 23 is integrally connected to the elongated frame element 12.

[0075] 10. The external fixator 100 of any one of embodiments 1 to 9, wherein the first pin mounting block 23 has a square or rectangular shape, and the elongated frame element 12 extends outward from one side surface of the first pin mounting block 23.35

[0076] 11. The external fixator 100 of any one of embodiments 1 to 10, wherein thePCT / US25 / 32413 05 June 2025 (05.06.2025) elongated frame element 12 has an overall width WEF that is less than an overall width WMB of the first pin mounting block 23.

[0077] 12. The external fixator 100 of any one of embodiments 1 to 11, wherein the elongated frame element 12 has an overall length LEF that is greater than an overall length LMB5 of the first pin mounting block 23.

[0078] 13. The external fixator 100 of any one of embodiments 1 to 12, wherein the elongated frame element 12 has an overall thickness TEF that is substantially equal to or equal to an overall thickness TMB of the first pin mounting block 23.

[0079] 14. The external fixator 100 of any one of embodiments 1 to 13, wherein the10 plurality of first pin mounting block apertures 26 comprises from 4 to 16 first pin mounting block apertures 26. It should be understood that any number of first pin mounting block apertures 26 may be present along the first pin mounting block 23.

[0080] 15. The external fixator 100 of any one of embodiments 1 to 14, wherein the plurality of first pin mounting block apertures 26 comprises 9 first pin mounting block apertures 26.

[0081] 16. The external fixator 100 of any one of embodiments 1 to 15, wherein the elongated frame element 12 comprises one or more elongated frame element apertures 36 extending through said elongated frame element 12 from the upper surface 131 to the lower surface 135 of the fixator body 13, each elongated frame element aperture 36 comprising (i) an elongated frame element aperture inlet 361 along the upper surface 131, (ii) an elongated frame element aperture outlet 362 along the lower surface 135, and (iii) an elongated frame element aperture inner side surface 363 extending between the elongated frame element aperture inlet 361 and the elongated frame element aperture outlet 362, wherein the elongated frame element aperture outlet 362 has an outlet cross-sectional area AAOEF that is smaller than an inlet cross-25 sectional area AAIEF of the elongated frame element aperture inlet 361.

[0082] 17. The external fixator 100 of embodiment 16, wherein each elongated frame element aperture 36 has a minimum cross-sectional area AAIMEF at the elongated frame element aperture outlet 362 or proximate the elongated frame element aperture outlet 362.

[0083] 18. The external fixator 100 of embodiment 17, wherein the minimum cross- sectional area AAIMEF is proximate the elongated frame element aperture outlet 362.

[0084] 19. The external fixator 100 of embodiment 16 or 17, wherein the minimum cross- sectional area AAIMEF is smaller than the cross-sectional area AAOEF at the elongated frame element aperture outlet 362.

[0085] 20. The external fixator 100 of any one of embodiments 16 to 19, wherein each35 elongated frame element aperture 36 is designed to allow a given vertically-extending bone pinPCT / US25 / 32413 05 June 2025 (05.06.2025)11, positioned therein, to be angularly disposed at an acute angle of greater than 0 up to about thirty degrees (30°) from a normal line N perpendicular to the elongated frame element 12. See, for example, the angular orientation of exemplary vertically-extending bone pin 11 shown in FIG. 1.5

[0086] 21. The external fixator 100 of any one of embodiments 16 to 20, wherein each elongated frame element aperture 36 is designed to allow a given bone pin 11, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about 20° from a normal line N perpendicular to the elongated frame element 12.10

[0087] 22. The external fixator 100 of any one of embodiments 16 to 21, wherein each elongated frame element aperture 36 is sized to receive a second spherical pin holder 39’ into the elongated frame element aperture inlet 361 so that the second spherical pin holder 39’ (i) contacts and rests upon a portion 363' of the elongated frame element aperture inner side surface 363 proximate the elongated frame element aperture outlet 362, and (ii) does not exit the elongated frame element aperture outlet 362. It should be noted that the second spherical pin holder 39’ may be identical to the first spherical pin holder 39 or may differ from the first spherical pin holder 39. For example, in some embodiments, the first spherical pin holder 39 may have a diameter of about 3.0 millimeters (mm), while the second spherical pin holder 39’ have a diameter of about 6.0 mm. It should be further noted that the second spherical pin holder 39’ and the first spherical pin holder 39 may independently have a desired diameter such that the second spherical pin holder 39’ or the first spherical pin holder 39 fit within a given elongated frame element aperture 36 or first pin mounting block aperture 26, respectively.

[0088] 23. The external fixator 100 of any one of embodiments 16 to 22, wherein each elongated frame element aperture 36 is sized to further receive a second channel-containing25 clamping component 40’ that (i) attaches to said fixator body 13 proximate the elongated frame element aperture inlet 361, (ii) prevents the second spherical pin holder 39’ from exiting a given elongated frame element aperture 36, and (iii) provides a clamping contact surface 403 along or proximate the second spherical pin holder 39’ when the second spherical pin holder 39’ and the second channel-containing clamping component 40’ are positioned within a given elongated frame element aperture 36. As with the second spherical pin holder 39’ and the first spherical pin holder 39, the second channel-containing clamping component 40’ and the first channel-containing clamping component 40 may each independently have a desired diameter / size / configuration such that the second channel-containing clamping component 40’ or the first channel-containing clamping component 40 fit within a given elongated frame35 element aperture 36 or first pin mounting block aperture 26, respectively.PCT / US25 / 32413 05 June 2025 (05.06.2025)

[0089] 24. The external fixator 100 of any one of embodiments 16 to 23, wherein the one or more elongated frame element apertures 36 comprises from 1 to 4 elongated frame element apertures 36. It should be understood that any number of elongated frame element apertures 36 may be present along the elongated frame element 12.5

[0090] 25. The external fixator 100 of any one of embodiments 16 to 24, wherein the one or more elongated frame element apertures 36 comprises 3 elongated frame element apertures 36.

[0091] 26. The external fixator 100 of any one of embodiments 16 to 25, wherein the one10 or more elongated frame element apertures 36 comprises (i) two elongated frame element apertures 36 with each having a circular shaped elongated frame element aperture inlet 361, and (ii) a single slot- like elongated frame element aperture 36 having an oval shaped elongated frame element aperture inlet 361.

[0092] 27. The external fixator 100 of embodiment 26, wherein (a) the single slot- like elongated frame element aperture 36 is proximate the rear end 133 of the fixator body 13, and (b) the two elongated frame element apertures 36 are positioned between the single slot-like elongated frame element aperture 36 and said first pin mounting block 23.

[0093] 28. The external fixator 100 of any one of embodiments 7 to 27, wherein said portion 263' of the mounting block aperture inner side surface 263 comprises a truncated20 conical shaped contact area 263' that surrounds a mounting block aperture channel 266 extending through first pin mounting block aperture 26.

[0094] 29. The external fixator 100 of any one of embodiments 22 to 28, wherein said portion 363' of the elongated frame element aperture inner side surface 363 comprises a truncated conical shaped contact area 363' that surrounds an elongated frame element aperture25 channel 366 extending through elongated frame element aperture 36.

[0095] 30. The external fixator 100 of embodiment 29, wherein the truncated conical shaped contact area 363' has a circular or an oval overall shape.

[0096] 31. The external fixator 100 of any one of embodiments 1 to 30, further comprising one or more first spherical pin holders 39, each first spherical pin holder 39 being sized and configured to (i) contact and rest upon a portion 263' of a mounting block aperture inner side surface 263 proximate the mounting block aperture outlet 262, and (ii) not exit the mounting block aperture outlet 262.

[0097] 32. The external fixator 100 of any one of embodiments 1 to 31, further comprising one or more first channel-containing clamping components 40, each first channel-containing35 clamping component 40 being sized and configured to (i) attach to said fixator body 13PCT / US25 / 32413 05 June 2025 (05.06.2025) proximate the mounting block aperture inlet 261, (ii) prevent a first spherical pm holder 39 from exiting a given first pin mounting block aperture 26, and (iii) provide a clamping contact surface 403 along or proximate the first spherical pin holder 39 when the first spherical pin holder 39 and the first channel-containing clamping component 40 are positioned within a5 given first pin mounting block aperture 26.

[0098] 33. The external fixator 100 of any one of embodiments 1 to 32, further comprising one or more second spherical pin holders 39’, each second spherical pin holders 39’ being sized and configured to (i) contact and rest upon a portion 363' of an elongated frame element aperture inner side surface 363 proximate an elongated frame element aperture outlet 362, and10 (ii) not exit the elongated frame element aperture outlet 362.

[0099] 34. The external fixator 100 of any one of embodiments 1 to 33, further comprising one or more second channel-containing clamping components 40’, each second channelcontaining clamping component 40’ being sized and configured to (i) attach to said fixator body 13 proximate an elongated frame element aperture inlet 361, (ii) prevent a second spherical pin holder 39’ from exiting a given elongated frame element aperture 36, and (iii) provide a clamping contact surface 403 along or proximate a second spherical pin holder 39’ when the second spherical pin holder 39’ and the second channel-containing clamping component 40’ are positioned within a given elongated frame element aperture 36.

[0100] 35. The external fixator 100 of any one of embodiments 1 to 34, further comprising one or more vertically-extending fragment pins 22, each vertically-extending fragment pin 22 being sized and configured to extend within and thru (i) a first channel-containing clamping component 40, (ii) a first spherical pin holder 39, and (ii) a first pin mounting block aperture 26, and into a bone fragment. Each of the vertically-extending fragment pins 22 includes a pointed end 24 for attachment within the bone fragment. If necessary, a portion 25 of25 vertically-extending fragment pins 22 extending upward from and above the fixator body 13 may be cut off after the vertically-extending fragment pins 22 are fastened in place.

[0101] 36. The external fixator 100 of any one of embodiments 1 to 35, further comprising one or more vertically-extending bone pins 11, each vertically-extending bone pin 11 being sized and configured to extend within and thru (i) a second channel-containing clamping component 40’, (ii) a second spherical pin holder 39’, and (ii) an elongated frame element aperture 36, and into a bone (e.g., the radius bone of the wrist). Each of the vertically-extending bone pins 11 includes a pointed end 14 for attachment to the bone (e.g., screw into bone).

[0102] 37. The external fixator 100 of any one of embodiments 1 to 36, further comprising an elongated frame element sleeve 70, said elongated frame element sleeve 70 (a) being sized35 and configured to slide over and onto said elongated frame element 12 at the rear end 133 ofPCT / US25 / 32413 05 June 2025 (05.06.2025) the fixator body 13 so as to extend over an elongated frame element aperture 36 positioned along said elongated frame element 12, and (b) comprising a sleeve aperture 71 extending vertically thru said sleeve 70, the sleeve aperture 71 comprising (i) a sleeve aperture inlet 72 along an upper sleeve surface 73 of sleeve 70, and (ii) a sleeve aperture outlet 74 along a lower5 sleeve surface 75 of sleeve 70. See, exemplary elongated frame element sleeve 70 shown in FIG. 18.

[0103] 38. The external fixator 100 of embodiment 37, wherein said sleeve aperture 71 is sized to receive a first spherical pin holder 39 or a second spherical pin holder 39’ into the sleeve aperture inlet 72 so that the first spherical pin holder 39 or a second spherical pin holder10 39’ (i) contacts and rests upon a portion 363' of an elongated frame element aperture inner side surface 363 proximate the sleeve aperture outlet 74, and (ii) does not exit the sleeve aperture outlet 74.

[0104] 39. The external fixator 100 of embodiment 38, wherein said sleeve aperture 71 is sized to further receive a first channel-containing clamping component 40 or a second channel¬15 containing clamping component 40’ that (i) attaches to said sleeve 70 proximate the sleeve aperture inlet 72, (ii) prevents the first spherical pin holder 39 or the second spherical pin holder 39’ from exiting a given sleeve aperture 71, and (iii) provides a clamping contact surface 403 along or proximate the first spherical pin holder 39 or the second spherical pin holder 39’ when the first spherical pin holder 39 or the second spherical pin holder 39’ and the first channelcontaining clamping component 40 or the second channel-containing clamping component 40’ are positioned within a given sleeve aperture 71.

[0105] 40. The external fixator 100 of any one of embodiments 1 to 39, wherein the elongated frame element 12 further comprises a spacer connector 125 extending along the lower surface 135 of the fixator body 13 and the elongated frame element 12.25

[0106] 41. The external fixator 100 of embodiment 40, wherein the spacer connector 125 extends across a width WFE of the elongated frame element 12.

[0107] 42. The external fixator 100 of any one of embodiments 1 to 41, further comprising a device spacer 126, said device spacer 126 (a) being attachable to the elongated frame element 12, and (b) comprising a device spacer connecting surface 127, and a patient contact surface 128 opposite the device spacer connecting surface 127. See, exemplary device spacer 126 shown in FIG. 19. It should be understood that device spacer 126 may have any desired dimensions. For example, a thickness TDS of the device spacer 126 may be specifically chosen for a given patient and procedure.

[0108] 43. The external fixator 100 of embodiment 42, wherein the device spacer 12635 further comprises a connecting groove 129 within the connecting surface 127, the connectingPCT / US25 / 32413 05 June 2025 (05.06.2025) groove 129 being configured to accept a spacer connector 125 of the elongated frame element 12.

[0109] 44. The external fixator 100 of any one of embodiments 1 to 43, further comprising a second pin mounting block 43 that is attachable to said fixator body 13 along a side edge 2355 of said first pin mounting block 23, said second pin mounting block 43 comprising a plurality of second pin mounting block apertures 46 extending through said second pin mounting block 43 from a front surface 431 to a rear surface 435 of the second pin mounting block 43, each second pin mounting block apertures 46 comprising (i) a second pin mounting block aperture inlet 461 along the front surface 431, (ii) a second pin mounting block aperture outlet 462 along10 the rear surface 435, and (iii) a second pin mounting block aperture inner side surface 463 extending between the second pin mounting block aperture inlet 461 and the second pin mounting block aperture outlet 462, wherein the second pin mounting block aperture outlet 462 has a cross-sectional area AAOSMB that is smaller than a cross-sectional area AAISMB of the second pin mounting block aperture inlet 461.

[0110] 45. The external fixator 100 of embodiment 44, wherein each second pin mounting block aperture 46 has a minimum cross-sectional area AAIMSMB at the second pin mounting block aperture outlet 462 or proximate the second pin mounting block aperture outlet 462.

[0111] 46. The external fixator 100 of embodiment 45, wherein the minimum cross- sectional area AAIMSMB is proximate the second pin mounting block aperture outlet 262.

[0112] 47. The external fixator 100 of embodiment 45 or 46, wherein the minimum cross- sectional area AAIMSMB is smaller than the cross-sectional area AAOSMB at the second pin mounting block aperture outlet 462.

[0113] 48. The external fixator 100 of any one of embodiments 44 to 47, wherein each second pin mounting block aperture 46 is designed to allow a given horizontally-extending25 fragment pin 22’, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about thirty degrees (30°) from a normal line N perpendicular to the second pin mounting block 43. See, for example, the angular orientation of exemplary horizontallyextending fragment pin 22’ shown in FIGS. 1, and 27A-27C.

[0114] 49. The external fixator 100 of any one of embodiments 44 to 48, wherein each second pin mounting block aperture 46 is designed to allow a given horizontally-extending fragment pin 22’, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about 20° from a normal line N perpendicular to the second pin mounting block 43.

[0115] 50. The external fixator 100 of any one of embodiments 44 to 49, wherein each second pin mounting block aperture 46 is sized to receive a first spherical pin holder 39 into35 the second pin mounting block aperture inlet 461 so that the first spherical pin holder 39 (i)PCT / US25 / 32413 05 June 2025 (05.06.2025) contacts and rests upon a portion 463 of the second pin mounting block aperture inner side surface 463 proximate the second pin mounting block aperture outlet 462, and (ii) does not exit the second pin mounting block aperture outlet 462.

[0116] 51. The external fixator 100 of embodiment 50 , wherein each second pin mounting5 block aperture 46 is sized to further receive a first channel-containing clamping component 40 that (i) attaches to said second pin mounting block 43 proximate the second pin mounting block aperture inlet 461, (ii) prevents the first spherical pin holder 39 from exiting a given second pin mounting block aperture 46, and (iii) provides a clamping contact surface 403 along or proximate the first spherical pin holder 39 when the first spherical pin holder 39 and the first10 channel-containing clamping component 40 are positioned within a given second pin mounting block aperture 46.

[0117] 52. The external fixator 100 of any one of embodiments 44 to 51, wherein said second pin mounting block 43 is attachable to the first pin mounting block 23 via a connecting bolt 80 (see, FIG. 26) that extends (i) thru a connecting hole 437 of said second pin mounting block 43, and (ii) into a corresponding connecting hole 237 within said side edge 235 of said first pin mounting block 23. As shown in FIG. 2, side edge 235 of first pin mounting block 23 may comprise one or more corresponding connecting holes 237 therein.

[0118] 53. The external fixator 100 of any one of embodiments 44 to 52, wherein said second pin mounting block 43 comprises a connecting projection 438 extending outward from said rear surface 435, said connecting projection 438 being sized and configured to extend within a corresponding projection- accepting hole 238 within said side edge 235 of said first pin mounting block 23. As shown in FIG. 2, side edge 235 of first pin mounting block 23 may comprise one or more corresponding projection- accepting holes 238 therein.

[0119] 54. The external fixator 100 of any one of embodiments 44 to 53, wherein said25 second pin mounting block 43 comprises one or more second pin mounting block holes 432 that extend into the front surface 431 of the second pin mounting block 43, but not thru to the rear surface 435 of the second pin mounting block 43. As shown in FIGS. 20 and 24, second pin mounting block 43 may comprise one or more second pin mounting block holes 432 therein.

[0120] 55. The external fixator 100 of any one of embodiments 44 to 54, wherein the second pin mounting block 43 has a square or rectangular shape, and an upper connecting portion 433 of the second pin mounting block 43 has a thickness TUSMB that is greater than a thickness TLSMB along a lower portion 434 of the second pin mounting block 43. See, for example, FIG. 20.

[0121] 56. The external fixator 100 of any one of embodiments 44 to 55, wherein the35 second pin mounting block 43 has an overall width WSMB that is less than an overall widthPCT / US25 / 32413 05 June 2025 (05.06.2025)WMB of the first pin mounting block 23.

[0122] 57. The external fixator 100 of any one of embodiments 44 to 56, wherein the second pin mounting block 43 has an overall length LSMB that is greater than or equal to an overall length LMB of the first pin mounting block 23.5

[0123] 58. The external fixator 100 of any one of embodiments 44 to 57, wherein the plurality of second pin mounting block apertures 46 comprises from 2 to 9 second pin mounting block apertures 46. It should be understood that any number of second pin mounting block apertures 46 may be present along the second pin mounting block 43.10

[0124] 59. The external fixator 100 of any one of embodiments 44 to 58, wherein the plurality of second pin mounting block apertures 46 comprises 4 second pin mounting block apertures 46.

[0125] 60. The external fixator 100 of any one of embodiments 50 to 59, wherein said portion 463' of the second pin mounting block aperture inner side surface 463 comprises a15 truncated conical shaped contact area 463' that surrounds a second pin mounting block aperture channel 466 extending through the second pin mounting block aperture 46.

[0126] 61. The external fixator 100 of embodiment 60, wherein the truncated conical shaped contact area 463' has a circular or an oval overall shape.

[0127] 62. The external fixator 100 of any one of embodiments 44 to 61 , further comprising one or more additional first spherical pin holders 39, each additional first spherical pin holder 39 being sized and configured to (i) contact and rest upon a portion 463' of a second pin mounting block aperture inner side surface 463 proximate the second pin mounting block aperture outlet 462, and (ii) not exit the second pin mounting block aperture outlet 462.

[0128] 63. The external fixator 100 of any one of embodiments 44 to 52, further comprising25 one or more additional first channel-containing clamping components 40, each additional first channel-containing clamping component 40 being sized and configured to (i) attach to said second pin mounting block 43 proximate the second pin mounting block aperture inlet 461, (ii) prevent an additional first spherical pin holder 39 from exiting a given second pin mounting block aperture 46, and (iii) provide a clamping contact surface 403 along or proximate the additional first spherical pin holder 39 when the additional first spherical pin holder 39 and the additional first channel-containing clamping component 40 are positioned within a given second pin mounting block aperture 46.

[0129] 64. The external fixator 100 of any one of embodiments 44 to 63, further comprising one or more horizontally-extending fragment pins 22’, each horizontally-extending fragment35 pins 22’ being sized and configured to extend within and thru (i) an additional first channel-PCT / US25 / 32413 05 June 2025 (05.06.2025) containing clamping component 40, (n) an additional first spherical pin holder 39, and (n) a second pin mounting block 43, and into a bone fragment. Each of the horizontally-extending fragment pins 22’ includes a pointed end 24 for attachment within the bone fragment. If necessary, a portion 25 of horizontally-extending fragment pins 22’ extending outward from5 the second pin mounting block 43 may be cut off after the horizontally-extending fragment pins 22’ are fastened in place.Kits for Forming External Fixators

[0130] 65. A kit for preparing the external fixator 100 of any one of embodiments 1 to 64,10 said kit comprising one or more fixator bodies, at least one of the one or more fixator bodies comprising the fixator body 13 described in any one of embodiments 1 to 43.

[0131] 66. The kit of embodiment 65, further comprising: one or more second pin mounting blocks 43 described in any one of embodiments 44 to 64.

[0132] 67. The kit of embodiment 65 or 66, further comprising: (i) one or more first15 spherical pin holders 39, (ii) one or more second spherical pin holders 39’, (iii) one or more first channel-containing clamping components 40, (iv) one or more second channel-containing clamping components 40’, (v) one or more elongated frame element sleeves 70, (vi) one or more device spacers 126, (vii) one or more bone-engaging pins 11 / 22 / 22’, (viii) one or more bolts 80, or (ix) any combination of two or more of (i) to (viii).Methods of Making External Fixators

[0133] 68. A method of making the external fixator 100 of any one of embodiments 1 to 64, or any component of the external fixator 100 described in any one of embodiments 1 to 64, or the kit of any one of embodiments 65 to 67, or any kit component described in any one of25 embodiments 65 to 67, said method comprising: forming a fixator body 13 that comprises (a) a first pin mounting block 23 extending along an upper surface 131 at a front end 132 of the fixator body 13, (b) an elongated frame element 12 extending from the first pin mounting block 23 along the upper surface 131 to a rear end 133 of the fixator body 13, and (c) a plurality of first pin mounting block apertures 26 extending through the first pin mounting block 23 from upper surface 131 to a lower surface 135 of the fixator body 13, each first pin mounting block aperture 26 comprising (i) a mounting block aperture inlet 261 along the upper surface 131, (ii) a mounting block aperture outlet 262 along the lower surface 135, and (iii) a mounting block aperture inner side surface 263 extending between the mounting block aperture inlet 261 and the mounting block aperture outlet 262, wherein each first pin mounting block aperture 26 is35 designed to allow a given vertically-extending fragment pin 22, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about thirty degrees (30°) from aPCT / US25 / 32413 05 June 2025 (05.06.2025) normal line N perpendicular to the first pin mounting block 23.

[0134] 69. The method of embodiment 68, further comprising forming: (i) one or more of the herein-described second pin mounting blocks 43, (ii) one or more of the herein-described first spherical pin holders 39, (iii) one or more of the herein-described second spherical pin5 holders 39’, (iv) one or more of the herein-described first channel-containing clamping components 40, (v) one or more of the herein-described second channel-containing clamping components 40’, (vi) one or more of the herein-described elongated frame element sleeves 70, (vii) one or more of the herein-described device spacers 126, (viii) one or more of the herein- described bone-engaging pins 11 / 22 / 22’; (ix) one or more of the herein-described bolts 80, or10 (x) any combination of two or more of (i) to (ix).

[0135] 70. The method of embodiment 68 or 69, wherein said forming step comprises one or more of: a thermoforming step, a machining step, a molding step, a cutting step, a drilling step, an extrusion step, a washing step, a sterilizing step, and an assembling step.Methods of Using External Fixators

[0136] 71. A method of using the external fixator 100 of any one of embodiments 1 to 64, or any component of the external fixator 100 described in any one of embodiments 1 to 64, or the kit of any one of embodiments 65 to 67, or any kit component described in any one of embodiments 65 to 67, said method comprising: (1) surgically implanting one or more vertically-extending fragment pins 22 into one or more bones, the one or more vertically- extending fragment pins 22 extending through (i) one or more first pin mounting block apertures 26, and (ii) one or more first spherical pin holders 39; (2) adjusting an angular orientation of one or more of the vertically-extending fragment pins 22, the angular orientation being adjustable up to about 30° from a normal line N extending through the first pin mounting25 block 23; and (3) after said adjusting step, locking the vertically-extending fragment pin 22 in a desired angular orientation via a first channel-containing clamping component 40.

[0137] 72. The method of embodiment 71, further comprising: (1) surgically implanting one or more horizontally-extending fragment pins 22’ into one or more bones, the one or more horizontally-extending fragment pins 22’ extending through (i) one or more second pin mounting block apertures 46, and (ii) one or more second spherical pin holders 39’; (2) adjusting an angular orientation of one or more of the horizontally-extending fragment pins 22’, the angular orientation being adjustable up to about 30° from a normal line N extending through the second pin mounting block 43; and (3) after said adjusting step, locking the horizontally-extending fragment pins 22’ in a desired angular orientation via a second channel¬35 containing clamping component 40’.PCT / US25 / 32413 05 June 2025 (05.06.2025)

[0138] 73. The method of embodiment 71 or 72, further comprising: (1) surgically implanting one or more vertically-extending bone pins 11 into one or more bones, the one or more vertically-extending bone pins 11 extending through (i) one or more elongated frame element apertures 36, and (ii) one or more second spherical pin holders 39’; (2) adjusting an5 angular orientation of one or more of the vertically-extending bone pins 11, the angular orientation being adjustable up to about 30° from a normal line N extending through the elongated frame element 12; and (3) after said adjusting step, locking the vertically-extending bone pins 11 in a desired angular orientation via a second channel-containing clamping component 40’.EXAMPLES

[0139] External fixators 100 such as those shown in FIGS. 1-27C, and described in embodiments 1 to 64 above, were used to position numerous bones within the wrist of a patient using (a) vertically-extending fragment pins 22 extending downward from the first pin15 mounting block 23, (b) the horizontally-extending fragment pins 22’ extending from the second pin mounting block 43, and (c) vertically-extending bone pins 11 extending from the elongated frame element 12.

[0140] It should be understood that although the above-described external fixators 100, fixator bodies 13, other external fixator components, and / or methods are described as “comprising” one or more components or steps, the above-described external fixators 100, fixator bodies 13, other external fixator components, and / or methods may “comprise,” “consists of,” or “consist essentially of’ any of the above-described components, features, or steps of the external fixators 100, fixator bodies 13, other external fixator components, and / or25 methods. Consequently, where the present invention, or a portion thereof, has been described with an open-ended term such as “comprising,” it should be readily understood that (unless otherwise stated) the description of the present invention, or the portion thereof, should also be interpreted to describe the present invention, or a portion thereof, using the terms “consisting essentially of’ or “consisting of’ or variations thereof as discussed below.

[0141] As used herein, the terms “comprises,” “comprising,” “includes,” “including,” “has,” “having,” “contains,” “containing,” “characterized by” or any other variation thereof, are intended to encompass a non-exclusive inclusion, subject to any limitation explicitly indicated otherwise, of the recited components. For example, an external fixator 100, a fixator body 13, other external fixator component, and / or method that “comprises” a list of elements (e.g.,35 components, features, or steps) is not necessarily limited to only those elements (or components or steps), but may include other elements (or components or steps) not expressly listed orPCT / US25 / 32413 05 June 2025 (05.06.2025) inherent to the external fixator 100, the fixator body 13, the other external fixator component, and / or the method.

[0142] As used herein, the transitional phrases “consists of’ and “consisting of’ exclude any element, step, or component not specified. For example, “consists of’ or “consisting of’ used5 in a claim would limit the claim to the components, materials or steps specifically recited in the claim except for impurities ordinarily associated therewith (i.e., impurities within a given component). When the phrase “consists of’ or “consisting of’ appears in a clause of the body of a claim, rather than immediately following the preamble, the phrase “consists of’ or “consisting of’ limits only the elements (or components or steps) set forth in that clause; other10 elements (or components) are not excluded from the claim as a whole.

[0143] As used herein, the transitional phrases “consists essentially of’ and “consisting essentially of’ are used to define an external fixator 100, a fixator body 13, other external fixator component, and / or method that includes materials, steps, features, components, or elements, in addition to those literally disclosed, provided that these additional materials, steps, features, components, or elements do not materially affect the basic and novel characteristic(s) of the claimed invention. The term “consisting essentially of’ occupies a middle ground between “comprising” and “consisting of.”

[0144] Further, it should be understood that the herein-described external fixators 100, fixator bodies 13, other external fixator components, and / or methods may comprise, consist essentially of, or consist of any of the herein-described components and features, with or without any additional feature(s). In other words, in some embodiments, the external fixators 100, fixator bodies 13, other external fixator components, and / or methods of the present invention do not have any additional features other than those described herein, and such additional features, not described herein, are specifically excluded from the external fixators25 100, fixator bodies 13, other external fixator components, and / or methods. In other embodiments, the external fixators 100, fixator bodies 13, other external fixator components, and / or methods of the present invention do have one or more additional features that are not described herein.

[0145] While the specification has been described in detail with respect to specific embodiments thereof, it will be appreciated that those skilled in the art, upon attaining an understanding of the foregoing, may readily conceive of alterations to, variations of, and equivalents to these embodiments. Accordingly, the scope of the present invention should be assessed as that of the appended claims and any equivalents thereto.35

Claims

PCT / US25 / 32413 05 June 2025 (05.06.2025)WHAT IS CLAIMED IS:

1. An external fixator for surgical attachment to one or more bones, said external fixator comprising:5 a fixator body that comprises:(a) a first pin mounting block extending along an upper surface at a front end of the fixator body,(b) an elongated frame element extending from said first pin mounting block along the upper surface to a rear end of the fixator body, and10 (c) a plurality of first pin mounting block apertures extending through said first pin mounting block from upper surface to a lower surface of the fixator body, each first pin mounting block aperture comprising(i) a mounting block aperture inlet along the upper surface,(ii) a mounting block aperture outlet along the lower surface, and(iii) a mounting block aperture inner side surface extending between the mounting block aperture inlet and the mounting block aperture outlet, wherein the mounting block aperture outlet has a cross-sectional area AAOMB that is smaller than a cross-sectional area AAIMB of the mounting block aperture inlet.

2. An external fixator for surgical attachment to one or more bones, said external fixator comprising: a fixator body that comprises:(a) a first pin mounting block extending along an upper surface at a front end of the fixator body,25 (b) an elongated frame element extending from said first pin mounting block along the upper surface to a rear end of the fixator body, and(c) a plurality of first pin mounting block apertures extending through said first pin mounting block from upper surface to a lower surface of the fixator body, each first pin mounting block aperture comprising(i) a mounting block aperture inlet along the upper surface,(ii) a mounting block aperture outlet along the lower surface, and(iii) a mounting block aperture inner side surface extending between the mounting block aperture inlet and the mounting block aperture outlet, wherein each first pin mounting block aperture is designed to allow a given vertically-35 extending fragment pin, positioned therein, to be angularly disposed at an acute angle of greaterPCT / US25 / 32413 05 June 2025 (05.06.2025) than 0 up to about thirty degrees (30 ) from a normal hne N perpendicular to the first pin mounting block.

3. The external fixator 100 of claim 1 or 2, wherein each first pin mounting block5 aperture 26 has a minimum cross-sectional area AAIMMB at the mounting block aperture outlet 262 or proximate the mounting block aperture outlet 262.

4. The external fixator 100 of claim 3, wherein the minimum cross-sectional area AAIMMB is proximate the mounting block aperture outlet 262.

105. The external fixator 100 of claim 2 or 3, wherein the minimum cross-sectional area AAIMMB is smaller than the cross-sectional area AAOMB at the mounting block aperture outlet 262.

6. The external fixator 100 of any one of claims 1 and 3 to 5, wherein each first pin mounting block aperture 26 is designed to allow a given vertically-extending fragment pin 22, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about thirty degrees (30°) from a normal line N perpendicular to the first pin mounting block 23.20 7. The external fixator 100 of any one of claims 1 to 6, wherein each first pin mounting block aperture 26 is designed to allow a given vertically-extending fragment pin 22, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about 20° from a normal line N perpendicular to the first pin mounting block 23.25 8. The external fixator 100 of any one of claims 1 to 7, wherein each first pin mounting block aperture 26 is sized to receive a first spherical pin holder 39 into the mounting block aperture inlet 261 so that the first spherical pin holder 39 (i) contacts and rests upon a portion 263' of the mounting block aperture inner side surface 263 proximate the mounting block aperture outlet 262, and (ii) does not exit the mounting block aperture outlet 262.

309. The external fixator 100 of claim 8, wherein each first pin mounting block aperture 26 is sized to further receive a first channel-containing clamping component 40 that (i) attaches to said fixator body 13 proximate the mounting block aperture inlet 261, (ii) prevents the first spherical pin holder 39 from exiting a given first pin mounting block aperture 26, and (iii)35 provides a clamping contact surface 403 along or proximate the first spherical pin holder 39PCT / US25 / 32413 05 June 2025 (05.06.2025) when the first spherical pin holder 39 and the first channel-containing clamping component 40 are positioned within a given first pin mounting block aperture 26.

10. The external fixator 100 of any one of claims 1 to 9, wherein the first pin mounting5 block 23 is integrally connected to the elongated frame element 12.

11. The external fixator 100 of any one of claims 1 to 10, wherein the first pin mounting block 23 has a square or rectangular shape, and the elongated frame element 12 extends outward from one side surface of the first pin mounting block 23.1012. The external fixator 100 of any one of claims 1 to 11, wherein the elongated frame element 12 has an overall width WEF that is less than an overall width WMB of the first pin mounting block 23.

13. The external fixator 100 of any one of claims 1 to 12, wherein the elongated frame element 12 has an overall length LEF that is greater than an overall length LMB of the first pin mounting block 23.

14. The external fixator 100 of any one of claims 1 to 13, wherein the elongated frame element 12 has an overall thickness TEF that is substantially equal to or equal to an overall thickness TMB of the first pin mounting block 23.

15. The external fixator 100 of any one of claims 1 to 14, wherein the plurality of first pin mounting block apertures 26 comprises from 4 to 16 first pin mounting block apertures 26.2516. The external fixator 100 of any one of claims 1 to 15, wherein the plurality of first pin mounting block apertures 26 comprises 9 first pin mounting block apertures 26.

17. The external fixator 100 of any one of claims 1 to 16, wherein the elongated frame element 12 comprises one or more elongated frame element apertures 36 extending through said elongated frame element 12 from the upper surface 131 to the lower surface 135 of the fixator body 13, each elongated frame element aperture 36 comprising (i) an elongated frame element aperture inlet 361 along the upper surface 131, (ii) an elongated frame element aperture outlet 362 along the lower surface 135, and (iii) an elongated frame element aperture inner side35 surface 363 extending between the elongated frame element aperture inlet 361 and thePCT / US25 / 32413 05 June 2025 (05.06.2025) elongated frame element aperture outlet 362, wherein the elongated frame element aperture outlet 362 has an outlet cross-sectional area AAOEF that is smaller than an inlet cross-sectional area AAIEF of the elongated frame element aperture inlet 361.5 18. The external fixator 100 of claim 17, wherein each elongated frame element aperture 36 has a minimum cross-sectional area AAIMEF at the elongated frame element aperture outlet 362 or proximate the elongated frame element aperture outlet 362.

19. The external fixator 100 of claim 18, wherein the minimum cross-sectional area10 AAIMEF is proximate the elongated frame element aperture outlet 362.

20. The external fixator 100 of claim 17 or 18, wherein the minimum cross-sectional area AAIMEF is smaller than the cross-sectional area AAOEF at the elongated frame element aperture outlet 362.

21. The external fixator 100 of any one of claims 17 to 20, wherein each elongated frame element aperture 36 is designed to allow a given vertically-extending bone pin 11, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about thirty degrees (30°) from a normal line N perpendicular to the elongated frame element 12.2022. The external fixator 100 of any one of claims 17 to 21, wherein each elongated frame element aperture 36 is designed to allow a given bone pin 11, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about 20° from a normal line N perpendicular to the elongated frame element 12.2523. The external fixator 100 of any one of claims 17 to 22, wherein each elongated frame element aperture 36 is sized to receive a second spherical pin holder 39’ into the elongated frame element aperture inlet 361 so that the second spherical pin holder 39’ (i) contacts and rests upon a portion 363' of the elongated frame element aperture inner side surface 36330 proximate the elongated frame element aperture outlet 362, and (ii) does not exit the elongated frame element aperture outlet 362.

24. The external fixator 100 of any one of claims 17 to 23, wherein each elongated frame element aperture 36 is sized to further receive a second channel-containing clamping35 component 40’ that (i) attaches to said fixator body 13 proximate the elongated frame elementPCT / US25 / 32413 05 June 2025 (05.06.2025) aperture mlet 361, (n) prevents the second spherical pin holder 39 from exiting a given elongated frame element aperture 36, and (iii) provides a clamping contact surface 403 along or proximate the second spherical pin holder 39’ when the second spherical pin holder 39’ and the second channel-containing clamping component 40’ are positioned within a given5 elongated frame element aperture 36.

25. The external fixator 100 of any one of claims 17 to 24, wherein the one or more elongated frame element apertures 36 comprises from 1 to 4 elongated frame element apertures 36. It should be understood that any number of elongated frame element apertures 36 may be10 present along the elongated frame element 12.

26. The external fixator 100 of any one of claims 17 to 25, wherein the one or more elongated frame element apertures 36 comprises 3 elongated frame element apertures 36.

27. The external fixator 100 of any one of claims 17 to 26, wherein the one or more elongated frame element apertures 36 comprises (i) two elongated frame element apertures 36 with each having a circular shaped elongated frame element aperture inlet 361, and (ii) a single slot-like elongated frame element aperture 36 having an oval shaped elongated frame element aperture inlet 361.2028. The external fixator 100 of claim 27, wherein (a) the single slot-like elongated frame element aperture 36 is proximate the rear end 133 of the fixator body 13, and (b) the two elongated frame element apertures 36 are positioned between the single slot-like elongated frame element aperture 36 and said first pin mounting block 23.2529. The external fixator 100 of any one of claims 8 to 28, wherein said portion 263' of the mounting block aperture inner side surface 263 comprises a truncated conical shaped contact area 263' that surrounds a mounting block aperture channel 266 extending through first pin mounting block aperture 26.3030. The external fixator 100 of any one of claims 23 to 29, wherein said portion 363' of the elongated frame element aperture inner side surface 363 comprises a truncated conical shaped contact area 363' that surrounds an elongated frame element aperture channel 366 extending through elongated frame element aperture 36.PCT / US25 / 32413 05 June 2025 (05.06.2025)31. The external fixator 100 of claim 30, wherein the truncated conical shaped contact area 363' has a circular or an oval overall shape.

32. The external fixator 100 of any one of claims 1 to 31, further comprising one or more5 first spherical pin holders 39, each first spherical pin holder 39 being sized and configured to (i) contact and rest upon a portion 263' of a mounting block aperture inner side surface 263 proximate the mounting block aperture outlet 262, and (ii) not exit the mounting block aperture outlet 262.10 33. The external fixator 100 of any one of claims 1 to 32, further comprising one or more first channel-containing clamping components 40, each first channel-containing clamping component 40 being sized and configured to (i) attach to said fixator body 13 proximate the mounting block aperture inlet 261, (ii) prevent a first spherical pin holder 39 from exiting a given first pin mounting block aperture 26, and (iii) provide a clamping contact surface 40315 along or proximate the first spherical pin holder 39 when the first spherical pin holder 39 and the first channel-containing clamping component 40 are positioned within a given first pin mounting block aperture 26.

34. The external fixator 100 of any one of claims 1 to 33, further comprising one or more second spherical pin holders 39’, each second spherical pin holders 39’ being sized and configured to (i) contact and rest upon a portion 363' of an elongated frame element aperture inner side surface 363 proximate an elongated frame element aperture outlet 362, and (ii) not exit the elongated frame element aperture outlet 362.25 35. The external fixator 100 of any one of claims 1 to 34, further comprising one or more second channel-containing clamping components 40’, each second channel-containing clamping component 40’ being sized and configured to (i) attach to said fixator body 13 proximate an elongated frame element aperture inlet 361, (ii) prevent a second spherical pin holder 39’ from exiting a given elongated frame element aperture 36, and (iii) provide a clamping contact surface 403 along or proximate a second spherical pin holder 39’ when the second spherical pin holder 39’ and the second channel-containing clamping component 40’ are positioned within a given elongated frame element aperture 36.

36. The external fixator 100 of any one of claims 1 to 35, further comprising one or more35 vertically-extending fragment pins 22, each vertically-extending fragment pin 22 being sizedPCT / US25 / 32413 05 June 2025 (05.06.2025) and configured to extend within and thru (i) a first channel-containing clamping component 40, (ii) a first spherical pin holder 39, and (ii) a first pin mounting block aperture 26, and into a bone fragment. Each of the vertically-extending fragment pins 22 includes a pointed end 24 for attachment within the bone fragment.

537. The external fixator 100 of any one of claims 1 to 36, further comprising one or more vertically-extending bone pins 11, each vertically-extending bone pin 11 being sized and configured to extend within and thru (i) a second channel-containing clamping component 40’, (ii) a second spherical pin holder 39’, and (ii) an elongated frame element aperture 36, and into10 a bone (e.g., the radius bone of the wrist).

38. The external fixator 100 of any one of claims 1 to 37, further comprising an elongated frame element sleeve 70, said elongated frame element sleeve 70 (a) being sized and configured to slide over and onto said elongated frame element 12 at the rear end 133 of the fixator body 13 so as to extend over an elongated frame element aperture 36 positioned along said elongated frame element 12, and (b) comprising a sleeve aperture 71 extending vertically thru said sleeve 70, the sleeve aperture 71 comprising (i) a sleeve aperture inlet 72 along an upper sleeve surface 73 of sleeve 70, and (ii) a sleeve aperture outlet 74 along a lower sleeve surface 75 of sleeve 70.2039. The external fixator 100 of claim 38, wherein said sleeve aperture 71 is sized to receive a first spherical pin holder 39 or a second spherical pin holder 39’ into the sleeve aperture inlet 72 so that the first spherical pin holder 39 or a second spherical pin holder 39’ (i) contacts and rests upon a portion 363' of an elongated frame element aperture inner side surface25 363 proximate the sleeve aperture outlet 74, and (ii) does not exit the sleeve aperture outlet 74.

40. The external fixator 100 of claim 39, wherein said sleeve aperture 71 is sized to further receive a first channel-containing clamping component 40 or a second channelcontaining clamping component 40’ that (i) attaches to said sleeve 70 proximate the sleeve aperture inlet 72, (ii) prevents the first spherical pin holder 39 or the second spherical pin holder 39’ from exiting a given sleeve aperture 71, and (iii) provides a clamping contact surface 403 along or proximate the first spherical pin holder 39 or the second spherical pin holder 39’ when the first spherical pin holder 39 or the second spherical pin holder 39’ and the first channelcontaining clamping component 40 or the second channel-containing clamping component 40’35 are positioned within a given sleeve aperture 71.PCT / US25 / 32413 05 June 2025 (05.06.2025)41. The external fixator 100 of any one of claims 1 to 40, wherein the elongated frame element 12 further comprises a spacer connector 125 extending along the lower surface 135 of the fixator body 13 and the elongated frame element 12.

542. The external fixator 100 of claim 41 , wherein the spacer connector 125 extends across a width WFE of the elongated frame element 12.

43. The external fixator 100 of any one of claims 1 to 42, further comprising a device10 spacer 126, said device spacer 126 (a) being attachable to the elongated frame element 12, and (b) comprising a device spacer connecting surface 127, and a patient contact surface 128 opposite the device spacer connecting surface 127.

44. The external fixator 100 of claim 43, wherein the device spacer 126 further comprises15 a connecting groove 129 within the connecting surface 127, the connecting groove 129 being configured to accept a spacer connector 125 of the elongated frame element 12.

45. The external fixator 100 of any one of claims 1 to 44, further comprising a second pin mounting block 43 that is attachable to said fixator body 13 along a side edge 235 of said first pin mounting block 23, said second pin mounting block 43 comprising a plurality of second pin mounting block apertures 46 extending through said second pin mounting block 43 from a front surface 431 to a rear surface 435 of the second pin mounting block 43, each second pin mounting block apertures 46 comprising (i) a second pin mounting block aperture inlet 461 along the front surface 431, (ii) a second pin mounting block aperture outlet 462 along the rear25 surface 435, and (hi) a second pin mounting block aperture inner side surface 463 extending between the second pin mounting block aperture inlet 461 and the second pin mounting block aperture outlet 462, wherein the second pin mounting block aperture outlet 462 has a cross- sectional area AAOSMB that is smaller than a cross-sectional area AAISMB of the second pin mounting block aperture inlet 461.

46. The external fixator 100 of claim 45, wherein each second pin mounting block aperture 46 has a minimum cross-sectional area AAIMSMB at the second pin mounting block aperture outlet 462 or proximate the second pin mounting block aperture outlet 462.35PCT / US25 / 32413 05 June 2025 (05.06.2025)47. The external fixator 100 of claim 46, wherein the minimum cross-sectional area AAIMSMB is proximate the second pin mounting block aperture outlet 262.

48. The external fixator 100 of claim 46 or 47, wherein the minimum cross-sectional area5 AAIMSMB is smaller than the cross-sectional area AAOSMB at the second pin mounting block aperture outlet 462.

49. The external fixator 100 of any one of claims 45 to 48, wherein each second pin mounting block aperture 46 is designed to allow a given horizontally-extending fragment pin10 22’, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about thirty degrees (30°) from a normal line N perpendicular to the second pin mounting block 43.

50. The external fixator 100 of any one of claims 45 to 49, wherein each second pin mounting block aperture 46 is designed to allow a given horizontally-extending fragment pin 22’, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about 20° from a normal line N perpendicular to the second pin mounting block 43.

51. The external fixator 100 of any one of claims 45 to 50, wherein each second pin mounting block aperture 46 is sized to receive a first spherical pin holder 39 into the second20 pin mounting block aperture inlet 461 so that the first spherical pin holder 39 (i) contacts and rests upon a portion 463' of the second pin mounting block aperture inner side surface 463 proximate the second pin mounting block aperture outlet 462, and (ii) does not exit the second pin mounting block aperture outlet 462.25 52. The external fixator 100 of claim 51, wherein each second pin mounting block aperture 46 is sized to further receive a first channel-containing clamping component 40 that (i) attaches to said second pin mounting block 43 proximate the second pin mounting block aperture inlet 461, (ii) prevents the first spherical pin holder 39 from exiting a given second pin mounting block aperture 46, and (iii) provides a clamping contact surface 403 along or proximate the first spherical pin holder 39 when the first spherical pin holder 39 and the first channel-containing clamping component 40 are positioned within a given second pin mounting block aperture 46.

53. The external fixator 100 of any one of claims 45 to 52, wherein said second pin35 mounting block 43 is attachable to the first pin mounting block 23 via a connecting bolt 80PCT / US25 / 32413 05 June 2025 (05.06.2025)(see, FIG. 26) that extends (i) thru a connecting hole 437 of said second pin mounting block 43, and (ii) into a corresponding connecting hole 237 within said side edge 235 of said first pin mounting block 23.5 54. The external fixator 100 of any one of claims 45 to 53, wherein said second pin mounting block 43 comprises a connecting projection 438 extending outward from said rear surface 435, said connecting projection 438 being sized and configured to extend within a corresponding projection- accepting hole 238 within said side edge 235 of said first pin mounting block 23.1055. The external fixator 100 of any one of claims 45 to 54, wherein said second pin mounting block 43 comprises one or more second pin mounting block holes 432 that extend into the front surface 431 of the second pin mounting block 43, but not thru to the rear surface 435 of the second pin mounting block 43.

56. The external fixator 100 of any one of claims 45 to 55, wherein the second pin mounting block 43 has a square or rectangular shape, and an upper connecting portion 433 of the second pin mounting block 43 has a thickness TUSMB that is greater than a thickness TLSMB along a lower portion 434 of the second pin mounting block 43.

57. The external fixator 100 of any one of claims 45 to 56, wherein the second pin mounting block 43 has an overall width WSMB that is less than an overall width WMB of the first pin mounting block 23.25 58. The external fixator 100 of any one of claims 45 to 57, wherein the second pin mounting block 43 has an overall length LSMB that is greater than or equal to an overall length LMB of the first pin mounting block 23.

59. The external fixator 100 of any one of claims 45 to 58, wherein the plurality of second pin mounting block apertures 46 comprises from 2 to 9 second pin mounting block apertures 46.

60. The external fixator 100 of any one of claims 45 to 59, wherein the plurality of second pin mounting block apertures 46 comprises 4 second pin mounting block apertures 46.35PCT / US25 / 32413 05 June 2025 (05.06.2025)61. The external fixator 100 of any one of claims 51 to 60, wherein said portion 463 of the second pin mounting block aperture inner side surface 463 comprises a truncated conical shaped contact area 463' that surrounds a second pin mounting block aperture channel 466 extending through the second pin mounting block aperture 46.

562. The external fixator 100 of claim 61, wherein the truncated conical shaped contact area 463' has a circular or an oval overall shape.

63. The external fixator 100 of any one of claims 45 to 62, further comprising one or10 more additional first spherical pin holders 39, each additional first spherical pin holder 39 being sized and configured to (i) contact and rest upon a portion 463' of a second pin mounting block aperture inner side surface 463 proximate the second pin mounting block aperture outlet 462, and (ii) not exit the second pin mounting block aperture outlet 462.

64. The external fixator 100 of any one of claims 45 to 63, further comprising one or more additional first channel-containing clamping components 40, each additional first channel-containing clamping component 40 being sized and configured to (i) attach to said second pin mounting block 43 proximate the second pin mounting block aperture inlet 461, (ii) prevent an additional first spherical pin holder 39 from exiting a given second pin mounting block aperture 46, and (iii) provide a clamping contact surface 403 along or proximate the additional first spherical pin holder 39 when the additional first spherical pin holder 39 and the additional first channel-containing clamping component 40 are positioned within a given second pin mounting block aperture 46.25 65. The external fixator 100 of any one of claims 45 to 64, further comprising one or more horizontally-extending fragment pins 22’, each horizontally-extending fragment pins 22’ being sized and configured to extend within and thru (i) an additional first channel-containing clamping component 40, (ii) an additional first spherical pin holder 39, and (ii) a second pin mounting block 43, and into a bone fragment.

66. A kit for preparing the external fixator 100 of any one of claims 1 to 65, said kit comprising one or more fixator bodies, at least one of the one or more fixator bodies comprising the fixator body 13 described in any one of claims 1 to 44.35PCT / US25 / 32413 05 June 2025 (05.06.2025)67. The kit of claim 66, further comprising: one or more second pm mounting blocks 43 described in any one of claims 45 to 65.

68. The kit of claim 66 or 67, further comprising: (i) one or more first spherical pin5 holders 39, (ii) one or more second spherical pin holders 39’, (iii) one or more first channelcontaining clamping components 40, (iv) one or more second channel-containing clamping components 40’, (v) one or more elongated frame element sleeves 70, (vi) one or more device spacers 126, (vii) one or more bone-engaging pins 11 / 22 / 22’, (viii) one or more bolts 80, or (ix) any combination of two or more of (i) to (viii).1069. A method of making the external fixator 100 of any one of claims 1 to 65, or any component of the external fixator 100 described in any one of claims 1 to 65, or the kit of any one of claims 66 to 68, or any kit component described in any one of claims 66 to 68, said method comprising: forming a fixator body 13 that comprises (a) a first pin mounting block 23 extending along an upper surface 131 at a front end 132 of the fixator body 13, (b) an elongated frame element 12 extending from the first pin mounting block 23 along the upper surface 131 to a rear end 133 of the fixator body 13, and (c) a plurality of first pin mounting block apertures 26 extending through the first pin mounting block 23 from upper surface 131 to a lower surface 135 of the fixator body 13, each first pin mounting block aperture 26 comprising (i) a mounting block aperture inlet 261 along the upper surface 131, (ii) a mounting block aperture outlet 262 along the lower surface 135, and (iii) a mounting block aperture inner side surface 263 extending between the mounting block aperture inlet 261 and the mounting block aperture outlet 262,25 wherein each first pin mounting block aperture 26 is designed to allow a given vertically-extending fragment pin 22, positioned therein, to be angularly disposed at an acute angle of greater than 0° up to about thirty degrees (30°) from a normal line N perpendicular to the first pin mounting block 23.

70. The method of claim 69, further comprising forming: (i) one or more of the herein-described second pin mounting blocks 43, (ii) one or more of the herein-described first spherical pin holders 39, (iii) one or more of the herein-described second spherical pin holders 39’, (iv) one or more of the herein-described first channel-containing clamping components 40, (v) one or more of the herein-described second35 channel-containing clamping components 40’, (vi) one or more of the herein-describedPCT / US25 / 32413 05 June 2025 (05.06.2025) elongated frame element sleeves 70, (vn) one or more of the herein-described device spacers 126, (viii) one or more of the herein-described bone-engaging pins 11 / 22 / 22’; (ix) one or more of the herein-described bolts 80, or (x) any combination of two or more of (i) to (ix).5 71. The method of claim 69 or 70, wherein said forming step comprises one or more of: a thermoforming step, a machining step, a molding step, a cutting step, a drilling step, an extrusion step, a washing step, a sterilizing step, and an assembling step.

72. A method of using the external fixator 100 of any one of claims 1 to 65, or any10 component of the external fixator 100 described in any one of claims 1 to 65, or the kit of any one of claims 66 to 68, or any kit component described in any one of claims 66 to 68, said method comprising:(1) surgically implanting one or more vertically-extending fragment pins 22 into one or more bones, the one or more vertically-extending fragment pins 22 extending through15 (i) one or more first pin mounting block apertures 26, and (ii) one or more first spherical pin holders 39;(2) adjusting an angular orientation of one or more of the vertically-extending fragment pins 22, the angular orientation being adjustable up to about 30° from a normal line N extending through the first pin mounting block 23; and(3) after said adjusting step, locking the vertically-extending fragment pin 22 in a desired angular orientation via a first channel-containing clamping component 40.

73. The method of claim 72, further comprising:(1) surgically implanting one or more horizontally-extending fragment pins 22’ into25 one or more bones, the one or more horizontally-extending fragment pins 22’ extending through (i) one or more second pin mounting block apertures 46, and (ii) one or more second spherical pin holders 39’;(2) adjusting an angular orientation of one or more of the horizontally-extending fragment pins 22’, the angular orientation being adjustable up to about 30° from a normal line N extending through the second pin mounting block 43; and(3) after said adjusting step, locking the horizontally-extending fragment pins 22’ in a desired angular orientation via a second channel-containing clamping component 40’.35PCT / US25 / 32413 05 June 2025 (05.06.2025)74. The method of claim 72 or 73, further comprising:(1) surgically implanting one or more vertically-extending bone pins 11 into one or more bones, the one or more vertically-extending bone pins 11 extending through (i) one or more elongated frame element apertures 36, and (ii) one or more second spherical pin holders5 39’;(2) adjusting an angular orientation of one or more of the vertically-extending bone pins 11, the angular orientation being adjustable up to about 30° from a normal line N extending through the elongated frame element 12; and(3) after said adjusting step, locking the vertically-extending bone pins 11 in a10 desired angular orientation via a second channel-containing clamping component 40’.20

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