Patent Publication Number: US-2022211414-A1

Title: Female polyaxial joint and method of using same

Description:
BACKGROUND 
     External fixation is a surgical treatment wherein pins or wires may be percutaneously placed through a body of a patient to secure an external scaffolding device, such that at least a portion of the stabilizing structure is positioned on the outside of the body of the patient. The external fixator may be used to stabilize fractured limbs, for example, in proper position. External fixator treatments may cause less disruption of soft tissue as compared to use of internal plates and intramedullary nails used in internal fixation treatments as the components used to provide stability are positioned entirely within a patient&#39;s body. Additionally, external fixation treatments may be used in soft tissue management resulting from acute or chronic trauma wherein skin quality may be compromised. Further, the temporary nature of pins and wires used in external fixation treatments may provide bone stability in cases of bone infection wherein the presence of entirely internal implants may make treatment of the infection challenging. 
     One type of external fixation treatment includes a circular frame fixator. Generally, the basic components of the circular frame fixator include rings, connecting rods, and struts. The frame encircles a limb and is attached to bone by pins inserted through the bone and limb. External rings may be linked to each other by the rods and struts allowing for movement of bone fragments without opening of a fracture site. The bone fragments can then be fixed in a rigid position for healing. Within the industry, the classic circular frame fixator is the Ilizarov external fixator. 
     The Ilizarov external fixator may be integrated with other circular frames, such as the Taylor Spatial Frame (TSF), for example. The TSF is a hexapod device that includes two or more aluminum or carbon fiber rings connected by struts. Each strut may be independently lengthened or shortened to achieve the desired results (e.g., compression at the fracture site, lengthening of bone segments). The TSF may be connected to the bone by wire or half pins. The attached bone segments may be manipulated in different axes and degrees of freedom such that angular, translational, rotational and length deformities may be corrected. 
     Polyaxial struts may be used within a circular frame to accommodate non-orthogonal orientations. To ease the process of building such frames, the struts may be constructed using the polyaxial joints to swivel and maintain orientation set by the surgeon rather than gravity. During building of the frame, strut angulation and positioning may be manipulated prior to fixing the strut to the frame. 
     Currently, two different types of struts exist in the marketplace for strut ring fixator frames: linear struts and polyaxial struts. This creates an added cost for manufacturers and flexibility of surgeons. Accordingly, a strut configured to behave as a linear and a polyaxial strut may be desirable using polyaxial joints. Further, having a polyaxial joint allowing for ease in removal of the polyaxial strut may be beneficial during treatment. 
    
    
     
       BRIEF DESCRIPTION OF THE DRAWINGS 
         FIG. 1  is a perspective view of an exemplary external fixation device in accordance with the present disclosure. 
         FIG. 2  is a perspective view of an exemplary strut for use in the external fixation device illustrated in  FIG. 1 . 
         FIG. 3A  is a cut-away view of an exemplary female polyaxial joint attached to a support frame in accordance with the present disclosure. 
         FIG. 3B  is a perspective view of an exemplary ball member for use in the female polyaxial joint illustrated in  FIG. 3A . 
         FIG. 3C  is a perspective view of an exemplary ball socket for use in the female polyaxial joint illustrated in  FIG. 3A . 
         FIG. 3D  is a perspective view of an exemplary polyaxial joint in accordance with the present disclosure. 
         FIGS. 4A and 4B  are cut-away views of the section AB illustrated in  FIG. 3A . 
         FIG. 5  is a cut-away view of another exemplary female polyaxial joint attached to a support frame in accordance with the present disclosure. 
         FIG. 6A  is a perspective view of an exemplary polyaxial stud joint in accordance with the present disclosure. 
         FIG. 6B  is a perspective view of an exemplary spring clip positioned on a ball member in accordance with the present disclosure. 
         FIG. 6C  is a cross-sectional view of an exemplary polyaxial stud joint in accordance with the present disclosure. 
         FIG. 7  is a flow chart of an exemplary method of attaching a female polyaxial joint to a support frame in accordance with the present disclosure. 
         FIG. 8  is a flow chart of an exemplary method of positioning a strut between a first support frame and a second support frame in accordance with the present disclosure. 
     
    
    
     DETAILED DESCRIPTION 
     Before explaining at least one embodiment of the inventive concept(s) in detail by way of exemplary language and results, it is to be understood that the inventive concept(s) is not limited in its application to the details of construction and the arrangement of the components set forth in the following description. The inventive concept(s) is capable of other embodiments or of being practiced or carried out in various ways. As such, the language used herein is intended to be given the broadest possible scope and meaning; and the embodiments are meant to be exemplary—not exhaustive. Also, it is to be understood that the phraseology and terminology employed herein is for the purpose of description and should not be regarded as limiting. 
     Unless otherwise defined herein, scientific and technical terms used in connection with the presently disclosed inventive concept(s) shall have the meanings that are commonly understood by those of ordinary skill in the art. Further, unless otherwise required by context, singular terms shall include pluralities and plural terms shall include the singular. The foregoing techniques and procedures are generally performed according to conventional methods well known in the art and as described in various general and more specific references that are cited and discussed throughout the present specification. 
     All patents, published patent applications, and non-patent publications mentioned in the specification are indicative of the level of skill of those skilled in the art to which this presently disclosed inventive concept(s) pertains. All patents, published patent applications, and non-patent publications referenced in any portion of this application are herein expressly incorporated by reference in their entirety to the same extent as if each individual patent or publication was specifically and individually indicated to be incorporated by reference. 
     All of the compositions, assemblies, systems, kits, and/or methods disclosed herein can be made and executed without undue experimentation in light of the present disclosure. While the compositions, assemblies, systems, kits, and methods of the inventive concept(s) have been described in terms of particular embodiments, it will be apparent to those of skill in the art that variations may be applied to the compositions and/or methods and in the steps or in the sequence of steps of the methods described herein without departing from the concept, spirit, and scope of the inventive concept(s). All such similar substitutions and modifications apparent to those skilled in the art are deemed to be within the spirit, scope, and concept of the inventive concept(s) as defined by the appended claims. 
     As utilized in accordance with the present disclosure, the following terms, unless otherwise indicated, shall be understood to have the following meanings: 
     The use of the term “a” or “an” when used in conjunction with the term “comprising” in the claims and/or the specification may mean “one,” but it is also consistent with the meaning of “one or more,” “at least one,” and “one or more than one.” As such, the terms “a,” “an,” and “the” include plural referents unless the context clearly indicates otherwise. Thus, for example, reference to “a compound” may refer to one or more compounds, two or more compounds, three or more compounds, four or more compounds, or greater numbers of compounds. The term “plurality” refers to “two or more.” 
     The use of the term “at least one” will be understood to include one as well as any quantity more than one, including but not limited to, 2, 3, 4, 5, 10, 15, 20, 30, 40, 50, 100, etc. The term “at least one” may extend up to 100 or 1000 or more, depending on the term to which it is attached; in addition, the quantities of 100/1000 are not to be considered limiting, as higher limits may also produce satisfactory results. In addition, the use of the term “at least one of X, Y, and Z” will be understood to include X alone, Y alone, and Z alone, as well as any combination of X, Y, and Z. The use of ordinal number terminology (i.e., “first,” “second,” “third,” “fourth,” etc.) is solely for the purpose of differentiating between two or more items and is not meant to imply any sequence or order or importance to one item over another or any order of addition, for example. 
     The use of the term “or” in the claims is used to mean an inclusive “and/or” unless explicitly indicated to refer to alternatives only or unless the alternatives are mutually exclusive. For example, a condition “A or B” is satisfied by any of the following: A is true (or present) and B is false (or not present), A is false (or not present) and B is true (or present), and both A and B are true (or present). 
     As used herein, any reference to “one embodiment,” “an embodiment,” “some embodiments,” “one example,” “for example,” or “an example” means that a particular element, feature, structure, or characteristic described in connection with the embodiment is included in at least one embodiment. The appearance of the phrase “in some embodiments” or “one example” in various places in the specification is not necessarily all referring to the same embodiment, for example. Further, all references to one or more embodiments or examples are to be construed as non-limiting to the claims. 
     Throughout this application, the term “about” is used to indicate that a value includes the inherent variation of error for a composition/apparatus/device, the method being employed to determine the value, or the variation that exists among the study subjects. For example, but not by way of limitation, when the term “about” is utilized, the designated value may vary by plus or minus twenty percent, or fifteen percent, or twelve percent, or eleven percent, or ten percent, or nine percent, or eight percent, or seven percent, or six percent, or five percent, or four percent, or three percent, or two percent, or one percent from the specified value, as such variations are appropriate to perform the disclosed methods and as understood by persons having ordinary skill in the art. 
     As used in this specification and claim(s), the words “comprising” (and any form of comprising, such as “comprise” and “comprises”), “having” (and any form of having, such as “have” and “has”), “including” (and any form of including, such as “includes” and “include”), or “containing” (and any form of containing, such as “contains” and “contain”) are inclusive or open-ended and do not exclude additional, unrecited elements or method steps. 
     The term “or combinations thereof” as used herein refers to all permutations and combinations of the listed items preceding the term. For example, “A, B, C, or combinations thereof” is intended to include at least one of: A, B, C, AB, AC, BC, or ABC, and if order is important in a particular context, also BA, CA, CB, CBA, BCA, ACB, BAC, or CAB. Continuing with this example, expressly included are combinations that contain repeats of one or more item or term, such as BB, AAA, AAB, BBC, AAABCCCC, CBBAAA, CABABB, and so forth. The skilled artisan will understand that typically there is no limit on the number of items or terms in any combination, unless otherwise apparent from the context. 
     As used herein, the term “substantially” means that the subsequently described event or circumstance completely occurs or that the subsequently described event or circumstance occurs to a great extent or degree. For example, when associated with a particular event or circumstance, the term “substantially” means that the subsequently described event or circumstance occurs at least 80% of the time, or at least 85% of the time, or at least 90% of the time, or at least 95% of the time. For example, the term “substantially adjacent” may mean that two items are 100% adjacent to one another, or that the two items are within close proximity to one another but not 100% adjacent to one another, or that a portion of one of the two items is not 100% adjacent to the other item but is within close proximity to the other item. 
     The term “patient” as used herein includes human and veterinary subjects. “Mammal” for purposes of treatment refers to any animal classified as a mammal, including (but not limited to) humans, domestic and farm animals, nonhuman primates, and any other animal that has mammary tissue. In some embodiments, the term “patient” may apply to a simulation mannequin for use in teaching, for example. 
     The term “treatment” refers to both therapeutic treatment and prophylactic or preventative measures. Those in need of treatment include, but are not limited to, individuals already having a particular condition/disease/infection as well as individuals who are at risk of acquiring a particular condition/disease/infection (e.g., those needing prophylactic/preventative measures). The term “treating” refers to administering an agent/element/method to a patient for therapeutic and/or prophylactic/preventative purposes. 
     Administering a therapy in relation to external fixation treatment is intended to provide a therapeutic benefit in the treatment, prevention, and/or management of a disease, condition, and/or infection. The specific amount in relation to time or quantity that is therapeutically effective can be readily determined by the ordinary medical practitioner, and can vary depending on factors known in the art, such as (but not limited to) the type of condition/disease/infection, the patient&#39;s history and age, the stage of the condition/disease/infection, and the co-administration of other agents or treatments. 
     The term “effective amount” refers to an amount of a treatment protocol in relation to external fixation, sufficient to exhibit a detectable therapeutic effect commensurate with a reasonable benefit/risk ratio when used in the manner of the inventive concept(s). The therapeutic effect may include, for example but not by way of limitation, preventing, inhibiting, or reducing the occurrence of a bone fracture, for example. The effective treatment for a subject will depend upon the type of subject, the subject&#39;s size and health, the nature and severity of the condition/disease/infection to be treated, the method of administration, the duration of treatment, the nature of concurrent therapy or treatment (if any), the specific formulations employed, and the like. 
     As used herein, the term “concurrent therapy” is used interchangeably with the terms “combination therapy” and “adjunct therapy,” and will be understood to mean that the patient in need of external fixation treatment is treated or given another treatment or drug for the condition/disease/infection in conjunction with the external fixation treatment(s) of the present disclosure. This concurrent therapy can be sequential therapy, where the patient is treated first with one treatment protocol/pharmaceutical composition and then the other treatment protocol/pharmaceutical composition, or the two treatment protocols/pharmaceutical compositions are given simultaneously. 
     The terms “administration” and “administering,” as used herein, will be understood to include all routes of administration known in the art, including but not limited to, oral, topical, transdermal, parenteral, subcutaneous, intranasal, mucosal, intramuscular, intraperitoneal, intravitreal, and intravenous routes, and including both local and systemic applications. In addition, the compositions of the present disclosure (and/or the methods of administration of same) may be designed to provide delayed, controlled, or sustained release using formulation techniques which are well known in the art. 
     Referring now to the drawings, and in particular  FIGS. 1-3 , shown therein is an exemplary embodiment of an external fixation device  10  in accordance with the present disclosure. The external fixation device  10  includes one or more struts  12  designed to engage with two or more support frames  14 . Each strut  12  of the external fixation device  10  includes one or more female polyaxial joints  16  having an internal surface  18  configured to engage with a connector  20 , such as a connector  20 . When the connector  20  is a threaded connector, such as a screw or bolt, the internal surface  18  can be threaded. In this embodiment, the connector  20  being the connector  20  secures the strut  12  to the support frame  14 . 
     As used herein, the term “support frame”  14  is used interchangeably with the term “ring”  14 . The support frame  14 , however, may be understood to be any shape (e.g., circular, triangular, square, fanciful, etc.) and is not limited to a circular ring shape. Further, as one skilled in the art will appreciate, the support frame  14  or ring may be a fully closed, partially open, or arch depending on treatment protocol known in the art. Diameter, thickness, and stiffness of the support frame  14  may depend on treatment protocol. Additionally, two or more support frames  14  having different diameter, thickness and/or stiffness may be used within the external fixation device  10 . Distance between two or more support frames  14  may also depend on treatment protocol. 
     The support frame  14  includes one or more apertures  22  with each aperture  22  configured to receive a shaft  21  of the connector  20 . In the example shown, the support frame  14  includes many apertures  22 . For purposes of clarity, only one of the apertures  14  has been labeled in  FIG. 1 . The support frame  14  has a first side  24  and a second side  26 . Each aperture  22  of the support frame  14  extends between the first side  24  and the second side  26 . The shaft  21  of the connector  20  may be positioned in the aperture  22  and extends from the first side  24  to the second side  26  with a head fastener  23  of the connector  20  positioned on the first side  24  of the support frame  14 . The shaft  21  of the connector  20  is further positioned and secured within the female polyaxial joint  16  connected at the second side  26  of the support frame  14 . To that end, the connector  20  having the head fastener  23  positioned on the first side  24  of the support frame  14  and the shaft  21  of the connector  20  extending through the aperture  22  of the support frame  14  and into the female polyaxial joint  16  secures the strut  12  to the second side  26  of the support frame  14 . The head fastener  23  may be provided with an external shape so as to engage with a tool (e.g., wrench or socket) for rotating the head fastener  23 . For example, the external shape can be square, hexagonal, or octagonal. In other embodiments, the head fastener  23  may be provided with a slot or opening to receive the tool. The slot or opening can be of a variety of types, such as hexagonal, philips, regular, star, square or the like. 
     The strut  12  is an adjustable rod that may be positioned between two support frames  14 . Each strut  12  may include a housing  30  extending between a first end  32  and a second end  34  of the strut  12  and is configured to be independently lengthened or shortened relative to the support frames  14  (e.g., forcing two interconnected support frames  14  towards each other, forcing two interconnected support frames  14  apart from each other). Adjustment of the strut  12  may provide for manipulation of one or more bone segments within multiple axes during treatment. 
     In some embodiments, the housing  30  of the strut  12  may be a telescopic housing extending from the first end  32  to the second end  34 . To that end, the strut  12  may include one or more portions configured to be slidably received within one or more channels of the strut  12  allowing for adjustment of the end-to-end length of the strut  12 . An adjustment mechanism  36  may be configured to allow for adjustment of end-to-end length of the strut  12  for a particular treatment protocol. The adjustment mechanism  36  may include any configuration known in the art allowing for end-to-end length adjustment of the strut  12 . In some embodiments, the adjustment mechanism  36  may be a wheel configured to be gradually rotated to translate movement of a rod within the housing  30  of the strut  12  adjusting the end-to-end length of the strut  12 . In some embodiments, the adjustment mechanism  36  may include a locking mechanism to prevent engagement or disengagement. 
     Referring to  FIGS. 2 and 3 , each strut  12  of the external fixation device  10  includes one or more female polyaxial joints  16  having the internal surface  18  configured to engage with the connector  20 . The connector  20  secures the strut  12  to the support frame  14 . In some embodiments, each strut  12  of the external fixation device  10  includes two female polyaxial joints  16  having the internal surfaces  18  configured to engage with the connectors  20  such that the first female polyaxial joint  16  is positioned at the first end  32  of the strut  12  and the second female polyaxial joint  16  is positioned at the second end  34  of the strut  12 . In some embodiments, as shown in  FIG. 2 , the strut  12  may include the female polyaxial joint  16  having the internal surface  18  configured to engage with the connector  20  positioned at the first end  32  of the strut  12 . A polyaxial stud joint  116  may be provided on the second end  34  of the strut  12 . Each of the female polyaxial joint  16  and polyaxial stud joint  116  may provide for angular and rotational alignment of the strut  12  relative to the support frame  14 . 
     Referring to  FIGS. 3A-3C , each female polyaxial joint  16  having the internal surface  18  may include a ball socket  40  and a ball member  42 . The ball member  42  may be rotatably coupled to the ball socket  40  providing pivoting movement between the strut  12  and the support frame  14 . 
     Referring to  FIG. 3B , the ball member  42  includes a first end  50  and a second end  52 . A spherical portion  54  terminates at the first end  50  and extends away from the first end  50  towards the second end  52 . Size and shape of the spherical portion  54  may be configured to fit within the ball socket  40  while maintaining pivoting and rotational movement of the female polyaxial joint  16 , i.e., the ball socket  40  on a spherically shaped portion of the spherical portion  54 . In some embodiments, a ball member shaft  56  extends from the spherical portion  54  to the second end  52  of the ball member  42 . Thus, in these embodiments the spherical portion  54  terminates prior to the second end  52 , and an aperture  58  is positioned at the second end  52  of the ball member  42  to provide access to the internal surface  18 . The aperture  58  may extend through the ball member shaft  56  and into the spherical portion  54 . In some embodiments, the aperture  58  having the internal surface  18  extends solely through the ball member shaft  56  of the ball member  42 . In some embodiments, the aperture  58  having the internal surface  18  extends through the ball member shaft  56  of the ball member  42  and through at least a portion of the spherical portion  54 . The aperture  58  providing access to the internal surface  18  is configured to receive the shaft  21  of the connector  20 . As the shaft  21  of the connector  20  is received within the aperture  58 , the ball member  42  may be drawn towards the ball socket  40  and create friction between the ball member  42  and the ball socket  40 . 
     Referring to  FIG. 3C , the ball socket  40  may partially enclose the spherical portion  54  of the ball member  42  such that the ball member  42  is operable received within the ball socket  40  while maintaining rotational movement. In some embodiments, the ball socket  40  may include one or more projections  60  configured to provide an enclosure  62  to receive the ball member  42 . The one or more projections  60  may form the enclosure  62  confining the ball member  42 . Each of the projections  60  may include an arcuate shape configured to matingly engage at least a portion of the spherical portion  54  of the ball member  42  The enclosure  62  may have a diameter less than the diameter of the spherical portion  54  of the ball member  42  such that the spherical portion  54  of the ball member  42  is confined within the enclosure  62  yet capable of rotation about a number of axes. The ball member shaft  56  of the ball member extends beyond the enclosure  62 . 
     Referring to  FIGS. 3A and 3C , in some embodiments, the ball socket  40  may be formed in the first end  32  and/or the second end  34  of the strut  12 . To that end, the ball member  42  may be rotatably coupled within the first end  32  and/or the second end  34  of the strut  12  providing pivoting movement between the housing  30  of the strut  12  and the support frame  14  (i.e., via the connector  20 ). For example, the first end  32  of the strut  12  may include the one or more projections  60  forming the enclosure  62  having a diameter less than a diameter of the ball member  42  such that the ball member  42  is confined within the enclosure while capable of rotation about a number of axes. In some embodiments, the ball socket  40  may be separate from the strut  12  and connected to the strut  12  via one or more securing mechanisms  70  as illustrated in  FIG. 3D . The securing mechanism  70  may use any type of fastener and/or head fastener. 
     The female polyaxial joint  16  may also use one or more securing mechanism  70  operably connected to the strut  12  and/or one or more portions of the female polyaxial joint  16  to tighten and/or lock the female polyaxial joint  16  (e.g., ball member  42 , ball socket  40 ). The securing mechanism(s)  70  may use any type of fastener and/or head fastener. 
     Referring to  FIGS. 3D, 4A and 4B , in some embodiments, the female polyaxial joint  16  may include a collar  72 . The collar  72  may be positioned between the ball socket  40  and the support frame  14 . In some embodiments, the collar  72  may be positioned such that the ball member  42  of the female polyaxial joint  16  is separated from the support frame  14  (e.g., a gap exists between the ball member  42  of the female polyaxial joint  16  and the support frame  14 ). 
     In some embodiments, the collar  72  and the ball member  42  may be rotationally keyed and captivated with an interference fit (e.g., a stepped fit or captive fit). For example, in some embodiments, the collar  72  may provide a lock and key anti-rotation relationship with the ball member shaft  56  of the ball member  42  in that each of the ball member shaft  56  and collar  72  possess a specific complementary geometric shape that matingly engage, i.e., fit to the other. The collar  72  may use mechanical force via the lock and key anti-rotation relationship to secure the ball member shaft  56  of the ball member  42  in a stationary position in which the ball socket  40  can pivot and/or rotate about the spherical portion  54 . As shown in  FIG. 4A , the ball member shaft  56  of the ball member  42  may include at least one external side  74  configured to engage with at least one internal side  76  of the collar  72 .  FIG. 4B  illustrates another exemplary embodiment of the ball member shaft  56   a  and the collar  72   a  wherein the at least one external side  74   a  includes a zig-zag pattern configured to engage with the corresponding geometric pattern on the at least one internal side  76   a  of the collar  72   a . It should be noted that any complementary shape may be used. The complementary shape can be geometric or fanciful, for example. 
     As the connector  20  engages within the internal surface  18  via the aperture  58 , friction is created between the spherical portion  54 , the projections  60  of the ball socket  40  and the collar  72  locking and/or securing the female polyaxial joint  16  to the support frame  14 . Additionally, as the connector  20  engages and tightens within the internal surface  18  via the aperture  58 , friction is created between the collar  72  and the support frame  14  locking the strut  12  to the support frame  14 . 
       FIG. 5  illustrates another exemplary embodiment of a female polyaxial joint  16   a  wherein ball member shaft  56   a  of the ball member  42  extends through the aperture  22  of the support frame  14  from the second side  26  to the first side  24 . In some embodiments, the ball member shaft  56   a  of the ball member  42  may extend such that the ball member shaft  56   a  is flush (i.e., level or even) with the first side  24  of the support frame  14 . In some embodiments, the ball member shaft  56   a  of the ball member  42  may extend into at least a portion of the aperture  22  from the second side  26  towards the first side  24 . The connector  20  may secure the female polyaxial joint  16   a  via engagement with the internal surface  18 . 
     Referring to  FIG. 2  and  FIGS. 6A-6C , illustrated therein are exemplary embodiments of the polyaxial stud joint  116 . Generally, the polyaxial stud joint  116  includes a ball joint body  120  and ball joint stud member  122  rotatably coupled to the ball joint body  120 . The ball joint stud member  122  may include a ball member  124  and a shaft  126 . The ball joint body  120  may include a plurality of grooves  128  configured to accommodate the shaft  126  of the ball joint stud member  122 . The plurality of grooves  128  may also allow for acute angulation of the ball joint stud member  122  within the ball joint body  120  at specific angular positions as set by the surgeon. The polyaxial stud joint  116  may also include a ring contact portion  130 . The ring contact portion  130  may be attached to the ball joint stud member  122  using a pin  132 , for example, to inhibit rotation of the ball joint stud member  122  within the ring contact portion  130 . The shaft  126  may include a threaded surface to secure the strut  12  to the support frame  14 . 
     Referring to  FIGS. 6B and 6C , in some embodiments, the polyaxial stud joint  116  may include a spring clip member  134 . The spring clip member  134  may be configured to create friction between the ball member  124  as the ball member  124  rotates within the ball joint body  120  and further may be configured to maintain an adjustable position of the ball member  124  within the ball joint body  120 . In some embodiments, the spring clip member  134  may be C-shaped clip, however, it should be understood that the spring clip member  134  may be any shape including circular, rectangular, C-shaped, serpentine, or any fanciful shape. In some embodiments, the ball member  124  may be configured to fit within the opening of the spring clip member  134  as shown in  FIG. 6B . 
     Referring to  FIG. 6C , the ball joint body  120  may include a channel 136 sized to accommodate the spring clip member  134 . The ball member  124  of the ball joint stud member  122  may be rotatably accommodated by the spring clip member  134 . During use, the ball joint stud member  122  may be moved by the surgeon within the spring clip member  134 . The spring clip member  134  may be configured to create friction between the ball member  124  and the ball joint body  120  as the ball member  124  is rotated in the ball joint body  120  to maintain an adjustable position of the ball member  124  within the ball joint body  120 . 
     In some embodiments, the spring clip member  134  may be integrated into any layer of the polyaxial stud joint  116 . In some embodiments, a plurality of spring clip members  134  may be integrated into layers of the polyaxial stud joint  116 . In some embodiments, the spring clip member  134  may be positioned in one or more grooves of the ball member  124  and interface with a surface of the ball joint body  120 . 
     In some embodiments, the amount of friction created by the spring clip member  134  may be a function of contact surface coefficient and any normal forces created by the spring clip member  134 . In some embodiments, the spring clip member  134  may be any device that effectively creates friction between the ball member  124  and the ball joint body  120 . 
       FIG. 7  illustrates a flow chart  200  of an exemplary method of attaching the female polyaxial joint  16  to the support frame  14 . The female polyaxial joint  16  includes the internal surface  18  for receiving the connector  20 , which in this example will be described as a threaded connector, such as a screw or a bolt. In a step  202 , the female polyaxial joint  16  may be aligned with the aperture  22  on second side  26  of the support frame  14 . In a step  204 , the shaft  21  of the connector  20  may be inserted into the first side  24  of the support frame  14 , through the aperture  22  to the second side  26  of the support frame  14 , and into the aperture  58  of the ball member  42 . As the connector  20  is turned and thereby engages with an increasing amount of the internal surface  18  (e.g., threads) of the ball member  42 , friction may be created between the spherical portion  54  of the ball member  42  and the projections  60  of the ball socket  40 . Additionally, as the connector  20  increasingly engages with the ball member  42 , friction may be created between the projections  60  of the ball socket  40  and the collar  72  locking the female polyaxial joint  16 . Friction may also be created between the collar  72  and the support frame  14  locking the strut  12  to the support frame  14  of the external fixator device  10 . In a step  206 , the connector  20  may be tightened (e.g., rotated) such that the strut  12  is secured to the support frame  14  and the female polyaxial joint  16  is locked. 
     In some embodiments, the ball member  42  may be configured such that the ball member  42  does not contact the support frame  14  during use (i.e., a gap exists between the ball member  42  and the support frame  14  during use). In some embodiments, the ball member shaft  56  of the ball member  42  may traverse the aperture  22  of the support frame  14 . In some embodiments, the ball member  42  and the collar  72  may be rotationally keyed and captivated with an interference fit (e.g., stepped fit or captive fit). 
       FIG. 8  illustrates a flow chart  300  of an exemplary method for positioning the strut  12  between a first support frame  14   a  having a first aperture  20   a  and a second support frame  14   b  having a second aperture  20   b . The first end  32  of the strut  12  includes the female polyaxial joint  16  having the internal surface  18 . The second end  34  of the strut  12  includes the polyaxial stud joint  116 . In a step  302 , the shaft  126  of the polyaxial stud joint  116  on the second end  34  of the strut  12  may be positioned within the first aperture  22  of the first support frame  14 . The shaft  126  may be positioned such that the shaft  126  traverses the first aperture  22  from the second side  26  of the first support frame  14  to the first side  24  of the first support frame  14 . In a step  304 , the polyaxial stud joint  116  may be manipulated to an appropriate position for treatment. In a step  306 , the polyaxial stud joint  116  may be secured to the first support frame  14  (e.g., securing a nut to the shaft  126  of the polyaxial stud joint  116 ). In a step  308 , the female polyaxial joint  16  may be aligned with a second aperture  22   b  of the second support frame  14 . In a step  310 , the connector  20  may be positioned through the second aperture  20   b  of the second support frame  14  into the aperture  58  of the ball member  42  of the female polyaxial joint  16  having the internal surface  18  securing the strut  12  to the second support frame  14 . 
     While the present invention has been disclosed with reference to certain embodiments, numerous modifications, alterations, and changes to the described embodiments are possible without departing from the sphere and scope of the present invention, as defined in the appended claims. Accordingly, it is intended that the present invention not be limited to the described embodiments, but that it has the full scope defined by the language of the following claims, and equivalents thereof.