Patent Description:
The systems and devices described in this disclosure may be used for stabilization of a traumatic injury until a long-term stabilization device can be applied. Short-term or temporary stabilization may allow soft tissues to recover from trauma prior to definitive skeletal fixation; for example, reduction of swelling, healing of open wounds, and/or healing of skin abrasions prior to open reduction and internal fixation. External fixation may also be used when transportation is required from the site of initial care, such as a local or rural hospital to a secondary site with appropriate trauma capabilities, such as a regional trauma center. Short-term stabilization may also be used for injuries that occur during periods of time when appropriate trauma care is not available, such as after hours, until a skilled clinician becomes available. Short-term stabilization may be appropriate in battlefield or field hospital situations. There is a need for external fixation systems and methods which are simple, easy, and affordable. <CIT> discloses an articulating spinal rod system.

This disclosure is directed to a clamping assembly comprising a longitudinal member having a first end and a second end, the second end defining a first clamp; a second clamp configured to attach to the first end of the longitudinal member and connect to a rod assembly; a clamping member including a first end, a second end defining a spherical portion, and a third clamp, wherein the first clamp of the longitudinal member is configured to receive the second end of the clamping member, and wherein the spherical portion is configured to expand.

This disclosure is also directed to a metatarsal bone pin clamping assembly comprising: a longitudinal member having a first end and a second end, the second end defining a first clamp, the first clamp including a spherical clamping surface; a U-shaped clamp configured to attach to the first end of the longitudinal member and connect to a rod assembly; a clamping member including a first end, a second end defining a spherical portion configured to expand, and a third clamp; a first fixation bolt extending through a portion of the clamping member and the spherical portion;
a nut configured to receive an end of the first fixation bolt; and a first bone pin locking member including a spherical portion, wherein the first clamp of the longitudinal member is configured to receive the second end of the clamping member, wherein the spherical clamping surface of the first clamp is configured to receive the spherical portion and form a polyaxial joint between the clamping member and the longitudinal member, wherein the spherical portion is configured to expand when the first fixation bolt is turned and the nut is pulled into the spherical portion, and wherein the third clamp includes a spherical clamping surface configured to receive the spherical portion of the first bone pin locking member and form a polyaxial joint between the clamping member and a first bone pin.

This disclosure is also directed to an external fixation system comprising: a first clamp assembly; a second clamp assembly; a rod assembly secured to and extending between the first clamp assembly and the second clamp assembly, the first rod assembly including a first tubular member and a second tubular member received in the first tubular member; and a bone pin clamping assembly comprising: a longitudinal member having a first end and a second end, the second end defining a first clamp; a second clamp configured to attach to the first end of the longitudinal member and connect to the rod assembly; a clamping member including a first end, a second end defining a spherical portion, and a third clamp, wherein the first clamp of the longitudinal member is configured to receive the second end of the clamping member, wherein the spherical portion is configured to expand.

In another example, not forming part of the claimed invention is a method for external fixation of a limb, the limb having a first bone portion, the method comprising: securing a first bone pin to the first bone portion; attaching a pre-assembled external fixation system to the first bone pin, the external fixation system comprising a rod assembly; securing a second bone pin to a bone in a foot; attaching a clamping assembly to the rod assembly, the clamping assembly comprising: a longitudinal member having a first end and a second end, the second end defining a first clamp; a second clamp configured to attach to the first end of the longitudinal member and connect to the rod assembly; a clamping member including a first end, a second end defining a spherical portion, a bone pin locking member, and a third clamp configured to receive the bone pin locking member, wherein the first clamp of the longitudinal member is configured to receive the second end of the clamping member; aligning the bone pin locking member of the clamping assembly with the second bone pin; inserting the second bone pin into the bone pin locking member of the clamping assembly; and securing the bone pin locking member of the clamping assembly to the second bone pin.

<FIG> is a perspective view of an external fixation system, in accordance with this disclosure. The external fixation system <NUM> of <FIG> can be configured to immobilize an ankle joint, for example. In the example configuration depicted in <FIG>, the external fixation system <NUM> can include a clamp assembly <NUM>, a first rod assembly <NUM>, a second rod assembly <NUM>, a bone pin clamping assembly <NUM>, a first clamping strut assembly <NUM>, a second clamping strut assembly <NUM>, and a kickstand member <NUM>.

The clamp assembly <NUM> of <FIG> can include a clamp body <NUM> configured to receive one or more bone pins 118A, 118B, and having a first clamp <NUM> and a second clamp <NUM>. The first clamp <NUM> is configured to receive an end of the first rod assembly <NUM> and the second clamp <NUM> is configured to receive an end of the second rod assembly <NUM>. An example clamp assembly <NUM> is described in detail in commonly assigned <CIT>.

The first rod assembly <NUM> can include an outer or first tubular element <NUM>, an inner or second tubular element <NUM>, a locking screw <NUM>, and a rod clamp assembly <NUM>. The first tubular element <NUM> has a first end <NUM> and a second end <NUM> and shaft <NUM> extending therebetween. The second tubular element <NUM> has a first end <NUM> and a second end <NUM> and a shaft <NUM> extending therebetween. The first tubular element <NUM> is larger in diameter than and coaxially receives a portion of the second tubular element <NUM>. The tubular elements may be circular in cross-section as shown, or, in other embodiments, may be square, rectangular, triangular, or any other polygonal shape in cross-section. The tubular elements may also be referred to as rods, rod elements, or rod members.

The second rod assembly <NUM> is substantially similar to the first rod assembly <NUM> and, for purposes of conciseness, will not be described separately.

The first clamping strut assembly <NUM>, shown in more detail in <FIG>, can include a first clamp <NUM> configured to receive an end <NUM> of the first rod assembly <NUM>. The first clamping strut assembly <NUM> can include a first fixation bolt <NUM> that, when tightened, securingly engages the end <NUM> of the first rod assembly <NUM>. The first clamping strut assembly <NUM> can further include a second clamp <NUM> configured to securingly engage one or more bone pins 150A, 150B, e.g., calcaneal pins. As a fixation bolt is tightened (shown at <NUM> in <FIG>), the bone pins 150A, 150B can be secured between a plate <NUM> and a body <NUM> of the first clamping strut assembly <NUM>.

The second clamping strut assembly <NUM> is substantially similar to the first clamping strut assembly <NUM> and, for purposes of conciseness, will not be described separately.

The system <NUM> of <FIG> can further include a kickstand member <NUM>. The kickstand member <NUM> can be affixed to the first clamping strut assembly <NUM> using a second fixation bolt <NUM> and to the second clamping strut assembly <NUM> using a third fixation bolt (not depicted in <FIG>). When the second and third fixation bolts are loosened, the kickstand member <NUM> can be rotated behind the patient's heel (as shown in <FIG>) or under the patient's foot (not depicted).

When the kickstand member <NUM> is rotated under the foot, a clinician, e.g., physician, can grip the kickstand member, e.g., at portion <NUM>, and pull axially in order to get traction on the patient's ankle while setting the ankle fracture. When the kickstand member <NUM> is rotated behind the patient's ankle (as shown in <FIG>), the patient's foot can be elevated to improve blood flow, for example.

In the example configuration shown in <FIG>, the kickstand member <NUM> is not attached to the bone pins 150A, 150B extending into the patient's heel. Rather, the kickstand member <NUM> can include a portion <NUM> that can allow the member <NUM> to clear or avoid the bone pins 150A, 150B as the member <NUM> is rotated behind the heel.

As mentioned above, the system <NUM> includes the bone pin clamping assembly <NUM>, which is shown and described in more detail below with respect to <FIG>, <FIG>, <FIG>, and <FIG>. As described in more detail below, the bone pin clamping assembly <NUM> can provide a polyaxially rotating clamp, thereby providing increased range of motion and degrees of freedom over existing clamp design.

Advantageously, the increased range of motion and degrees of freedom provided by the bone pin clamping assembly <NUM> of this disclosure can eliminate the need for a spanning member that extends across a patient's foot, such as the spanning member <NUM> in FIG. <NUM> in commonly assigned <CIT>. The spanning member can obstruct a physician's view and can also interfere with the healing process, e.g., as the foot swells.

<FIG> is a side view of the external fixation system of <FIG>, in accordance with this disclosure. For purposes of conciseness, <FIG> will not be described separately.

<FIG> is a side view of the external fixation system of <FIG> and <FIG>, in accordance with this disclosure. For purposes of conciseness, <FIG> will not be described separately.

<FIG> is an exploded view of the clamping assembly <NUM> of the external fixation system of <FIG>. The clamping assembly <NUM> includes a longitudinal member <NUM> having a first end <NUM> and a second end <NUM>. As seen in <FIG>, the second end <NUM> of the longitudinal member <NUM> defines a first clamp <NUM>.

The clamping assembly <NUM> includes a second clamp <NUM> configured to attach to the first end <NUM> of the longitudinal member <NUM> and connect to a rod assembly, e.g., rod assembly <NUM> of <FIG>. In some example configurations, the second clamp can be a U-shaped clamp.

The second clamp <NUM> is configured to frictionally engage a rod assembly, e.g., rod assembly <NUM> of <FIG>. For example, the clamping assembly <NUM> can include a first, proximal fixation bolt <NUM> configured to extend through the first end <NUM> of the longitudinal member <NUM> and at least a portion of the second clamp <NUM>. The first fixation bolt <NUM> can be secured using a nut <NUM>, for example. When tightened, the first fixation bolt <NUM> can pull the sides of the second clamp <NUM> together, thereby securing the clamp <NUM> to the rod assembly <NUM>.

The clamping assembly <NUM> includes a bone pin clamping member <NUM> including a first end <NUM>, a second end <NUM> defining a spherical portion <NUM>, and at least a third clamp <NUM>. The third clamp <NUM> can be configured to receive a first bone pin, e.g., a metatarsal bone pin 216A.

The example configuration shown in <FIG> can include a fourth clamp <NUM> configured to receive a second bone pin, e.g., a metatarsal bone pin 216B.

In some examples, the first clamp <NUM> of the longitudinal member <NUM> can include a spherical clamping surface <NUM> configured to receive the spherical portion <NUM> of the second end <NUM> of the clamping member <NUM>. The spherical clamping surface <NUM> can include an inner surface configured to substantially conform to an outer surface of the spherical portion. A spherical portion can include, for example, a sphere or a truncated sphere (e.g., a sphere in which two opposing portions are truncated by parallel planes), where at least some of the spherical portion retains a spherical shape. As described in more detail below, the spherical portion <NUM> of the second end <NUM> of the clamping member <NUM> in combination with the first clamp <NUM> can provide a polyaxial joint <NUM> between the longitudinal member <NUM> and the clamping member <NUM>.

In an example configuration, the clamping member <NUM> and, in particular, the spherical portion <NUM> can be secured to the longitudinal member <NUM> using a second, distal fixation bolt <NUM>. In <FIG>, the second fixation bolt <NUM> can extend through a portion of the clamping member <NUM>. As shown in <FIG>, the second fixation bolt <NUM> can extend into the spherical portion <NUM>, which is configured to receive a first nut <NUM>. As the second fixation bolt <NUM> is turned, the nut <NUM> is drawn into the spherical portion <NUM>, causing the spherical portion <NUM> to expand against the inner surface of the first clamp <NUM>. In the example shown in <FIG>, the nut <NUM> can include tapered sides. The assembly <NUM> can include a second nut <NUM> to secure the fixation bolt <NUM>. In some examples, the spherical portion <NUM> can define one or more slots <NUM>, which can facilitate the expansion of the spherical portion <NUM>.

The clamping assembly <NUM> can also include a first bone pin locking member 200A. In example configurations that include a fourth clamp <NUM>, as shown in <FIG>, the clamping assembly <NUM> can include a second bone pin locking member 200B. The first and the second bone pin locking members 200A, 200B are collectively referred to as "bone pin locking members <NUM>" in this disclosure. The bone pin locking members <NUM> can be configured to receive respective bone pins, e.g., metatarsal bone pins (depicted in <FIG>).

In the example shown in <FIG>, the bone pin locking members <NUM> can include a spherical portion. The third clamp <NUM> can include a spherical clamping surface <NUM> configured to receive a spherical portion <NUM> of the first bone pin locking member 200A and form a polyaxial joint 218A between the clamping member <NUM> and a first bone pin 216A.

The spherical portion <NUM> of the first bone pin locking member 200A can be configured to compress when the third clamp <NUM> contracts.

Similarly, the fourth clamp <NUM> can include a spherical clamping surface <NUM> configured to receive a spherical portion <NUM> of the second bone pin locking member 200B and form a polyaxial joint 218B between the clamping member <NUM> and a second bone pin 216B.

The spherical portion <NUM> of the second bone pin locking member 200B can be configured to compress when the fourth clamp <NUM> contracts.

As seen in <FIG>, the clamping member <NUM> can define a first gap <NUM> and a second gap <NUM>. When the second fixation bolt <NUM> is turned and the nut <NUM> is pulled into the spherical portion <NUM> of the second end <NUM>, the first gap <NUM> closes and the third clamp <NUM> contracts against the spherical portion <NUM> of the first bone pin locking member 200A. Similarly, in configurations including a fourth clamp <NUM> (as shown in <FIG>), when the second fixation bolt <NUM> is turned and the nut <NUM> is pulled into the spherical portion <NUM> of the second end <NUM>, the second gap <NUM> closes and the fourth clamp <NUM> contracts against the spherical portion <NUM> of the second bone pin locking member 200B, causing the contraction of the spherical portion of the bone pin locking members <NUM>. The bone pin locking members <NUM> contract against the bone pins extending through the bone pin locking members <NUM> (depicted in <FIG>).

In some examples, the spherical portion of the bone pin locking members <NUM> can define one or more slots <NUM>, which can facilitate the contraction of the spherical portion of the bone pin locking members <NUM>.

<FIG> depict perspective views of the clamping assembly <NUM> of <FIG>. For purposes of conciseness, <FIG> will be described together.

The assembled clamping assembly <NUM> shown in <FIG> depicts the first bone pin locking member 200A and the second bone pin locking member 200B securing, respectively, a first bone 216A and a second bone pin 216B (collectively referred to as bone pins <NUM> in this disclosure), within the third clamp <NUM> and the fourth clamp <NUM>. As mentioned above, the third clamp <NUM> can include a spherical clamping surface <NUM> configured to receive a spherical portion <NUM> of the first bone pin locking member 200A and form a polyaxial joint 218A between the clamping member <NUM> and the first bone pin 200A, and, similarly, the fourth clamp <NUM> can include a spherical clamping surface <NUM> configured to receive a spherical portion <NUM> of the second bone pin locking member 200B and form a polyaxial joint 218B between the clamping member <NUM> and a second bone pin 216B.

In some example implementations, the multiple polyaxial joints, e.g., joint 218A, joint 218B, and joint <NUM> best shown <FIG>, of the clamping assembly <NUM> can advantageously allow a physician, for example, to secure the first bone pin 216A and the second bone pin 216B into a patient's foot, e.g., a metatarsal, and then attach the clamping assembly <NUM>, if desired. The physician can select an optimum placement of the bone pins because the clamping assembly <NUM> can be easily secured to the bone pins <NUM>, regardless of their orientation, after the bone pins <NUM> are secured. The physician is not limited by the clamping assembly <NUM> when selecting locations for bone pin placement.

After the bone pins <NUM> are secured to the bone(s), the physician can attach the second clamp <NUM> of the clamping assembly <NUM> to a rod assembly, e.g., rod assembly <NUM> of <FIG>), adjust the clamping member <NUM> (via the polyaxial joint <NUM>) to align the clamping member <NUM> with the bone pins <NUM>, insert the bone pins <NUM> into respective bone pin locking members <NUM>, and then tighten the fixation bolt <NUM> to secure the bone pins <NUM> within the third clamp <NUM> and the fourth clamp <NUM>. Alternatively, in some example implementations, the physician can first attach the clamping assembly <NUM> and then secure the bone pins <NUM> to the bone(s).

An example method of external fixation of a limb can include securing a first bone pin to the first bone portion, e.g., a portion of a tibia <NUM> of <FIG>. Then, a pre-assembled external fixation system, including a rod assembly, can be attached to the first bone pin, e.g., bone pin 118A of the external fixation system <NUM> of <FIG>. The physician can secure a second bone pin to a bone in a foot, e.g., bone pin 216A of <FIG>. The physician can attach a clamping assembly to the rod assembly, e.g., the clamping assembly <NUM> of <FIG>. When the clamping assembly is adjusted and/or positioned via the polyaxial joints to reach the second bone pin, the second bone pin 216A can be attached to the bone pin locking member 200A of the clamping assembly, and then the clamping assembly can be secured, e.g., the clamps tightened to prevent further adjustment or movement.

<FIG> is a cross-sectional view of the clamping assembly <NUM> of <FIG>. As mentioned above, the second end <NUM> of the clamping member <NUM> defines a spherical portion <NUM> that is configured to receive the nut <NUM>. In the example configuration of <FIG>, the spherical portion <NUM> configured to receive the nut <NUM> defines a tapered aperture <NUM>. In some examples, the tapered aperture <NUM> can taper from a first dimension at an outer portion to a second dimension toward a center of the spherical portion <NUM>, where the first dimension is larger than the second dimension.

As the fixation bolt <NUM> is turned, the nut <NUM> is pulled inward toward the center of the spherical portion <NUM>. In some examples, to facilitate the movement of the nut <NUM> toward the center of the spherical portion <NUM>, the sides of the nut <NUM> can be tapered to correspond to the tapered aperture <NUM>. As the nut <NUM> is pulled inward toward the center of the spherical portion <NUM>, the nut <NUM> causes the spherical portion <NUM> to expand outwardly against the first clamp <NUM> of the longitudinal member <NUM>.

<FIG> depicts an example of a clamping strut assembly, e.g., the first clamping strut assembly <NUM> of <FIG>. The clamping strut assembly <NUM> can include a body <NUM> having a first clamp <NUM> configured to receive an end of a rod assembly, e.g., a rod assembly <NUM> of <FIG>. A first fixation bolt <NUM> can extend through an end of the body <NUM>. When turned, the first fixation bolt <NUM> can close a gap <NUM> and tighten the first clamp <NUM>, thereby securingly engaging an end of the rod assembly.

The clamping strut assembly <NUM> can further include a second clamp <NUM> having a plate <NUM>, a second fixation bolt <NUM>, and a nut <NUM> to receive the bolt <NUM>. When the second fixation bolt <NUM> is tightened, the clamp <NUM> is configured to securingly engage one or more bone pins e.g., bone pins 150A, 150B of <FIG>. In some examples, the bone pins 150A and 150B can be calcaneal pins. As the second fixation bolt <NUM> is tightened, the bone pins 150A, 150B are secured between the plate <NUM> and the body <NUM> of the first clamping strut assembly <NUM>. In the example shown in <FIG>, the body <NUM> can define grooves 232A to receive each of the bone pins <NUM>. The plate <NUM> can define similar grooves 232B.

As shown and described above with respect to <FIG>, the system <NUM> of <FIG> can include a kickstand member <NUM> (shown in <FIG>). The body <NUM> of the clamping strut assembly <NUM> can include a protrusion <NUM> configured to mate with a corresponding recess or cavity defined by an end of the kickstand member <NUM>. A fixation bolt <NUM> (shown in <FIG>) can extend through the end of the kickstand member <NUM> and through the protrusion <NUM> of the clamping strut assembly <NUM>.

In some examples configuration, such as in <FIG>, the second clamp <NUM> of the clamping strut assembly <NUM> can be elevated. For example, the body <NUM> can include a portion <NUM>, e.g., a sloped portion, that can position the second clamp <NUM> above the rest of body <NUM>. As seen in <FIG>, the raised position of the clamp <NUM> can allow the bone pins <NUM> to be positioned such that when the kickstand member <NUM> is rotated behind the patient's heel, the bone pins <NUM> are above the kickstand member <NUM> and will not interfere with its movement.

The above description is intended to be illustrative, and not restrictive. For example, the above-described examples (or one or more aspects thereof) may be used in combination with each other. Other embodiments can be used, such as by one of ordinary skill in the art upon reviewing the above description. The Abstract is provided to allow the reader to quickly ascertain the nature of the technical disclosure. It is submitted with the understanding that it will not be used to interpret or limit the scope or meaning of the claims. Also, in the above Detailed Description, various features may be grouped together to streamline the disclosure. This should not be interpreted as intending that an unclaimed disclosed feature is essential to any claim. Rather, inventive subject matter may lie in less than all features of a particular disclosed embodiment.

Claim 1:
A clamping assembly (<NUM>) comprising:
a longitudinal member (<NUM>) having a first end (<NUM>) and a second end (<NUM>), the second end defining a first clamp (<NUM>);
a second clamp (<NUM>) configured to attach to the first end of the longitudinal member and connect to a rod assembly (<NUM>);
a clamping member (<NUM>) including a first end (<NUM>), a second end (<NUM>) defining a spherical portion, and a third clamp (<NUM>),
wherein the first clamp of the longitudinal member is configured to receive the second end of the clamping member, and
characterized in that the spherical portion (<NUM>) is configured to expand.