Patent Description:
Bones form the skeleton of the body and allow the body to be supported against gravity and to move and function in the world. Bone fractures can occur, for example, from an outside force or from a controlled surgical cut (an osteotomy).

Fractures to ribs or other bones are typically treated with plates and/or external fixation devices that involve a large incision and significant exposure. These plates and devices are typically secured to the bone by screws or similar means that penetrate the inner cortex or intramedullary canal of the bone, and thereby compromise the integrity of the bone and can lead to infection and other secondary complications. It would be desirable to have an improved device and method for repairing, stabilizing and/or fixating a fractured bone.

A bone fixation device is known from the <CIT>, from which the preamble of claim <NUM> derives.

Systems for repairing, stabilizing and/or fixating a fractured bone, such as a rib, and surgical methods (not claimed) for same. The systems may be used for temporary fixation, or permanent. The systems involve subcutaneous fixation, engaging the fractured bone through a patient's skin, but without penetrating the inner cortex or intramedullary canal of the rib (or other bone). The systems facilitate immediate stabilization of the fractured rib, while allowing normal chest wall motion during inspiration/exhalation. Further, the system is adjustable to match a patient's anatomy and the fracture pattern/location. The surgical method for the system is simple, minimally invasive and does not require large incisions.

The systems of the present disclosure include members that differ from traditional bone repair plates (e.g., for ribs) in that they are not pre-fabricated with a specific anatomical location, such as ribs on the right or left sides of the ribcage. Rather, the members of the disclosed system are agnostic to the right and left sides. Further, while traditional bone repair plates require adaptation to the anatomical curve of the patient, the systems of the present disclosure include members that are formed to contour to the shape and orientation of the specific patient, thereby constituting a patient-customized implant/fixation system.

According to the present invention, a bone fixation device is provided comprising: an expandable member capable of moving from a deflated state to an inflated state by infusing at least one light sensitive liquid into the expandable member, the light sensitive liquid being configured to cure within the expandable member to harden the expandable member; and two or more clamps configured to engage a rib bone and receive the expandable member such that the two or more clamps secure the expandable member to the rib bone, the inflation of the expandable member with the at least one light sensitive liquid configured to be adjustable to conform to a shape of the rib bone, and a ring member extending outwardly from each of the two or more clamps, the ring member configured to have an opening that is sized to receive the expandable member therein.

In some embodiments, the device includes a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, the expandable member being releasably engaged with the distal end of the delivery catheter.

In some embodiments, the two or more clamps include a posterior member and an anterior member. In some embodiments, the posterior member and the anterior member are movably connected to one another between an open position such that the clamp is configured to be positioned on the rib bone and a closed positioned such that the clamp is configured to secure to at least a portion of the rib bone. In some embodiments, the two or more clamps are shaped to receive the rib bone such that the two or more clamps extend around at least a portion of the rib bone. In some embodiments, the two or more clamps include a posterior member and an anterior member, and the posterior includes first and second arms configured to extend around a portion of a posterior side of the rib bone to secure the two or more clamps thereto. In some embodiments, the two or more clamps include at least one contact point on a surface of the two or more clamps that is configured to contact the rib bone such that the at least one contact point is configured to increase the grip of the two or more clamps on the rib bone. In some embodiments, the two or more clamps include first and second clamps positioned on either side of a fracture in the rib bone.

In some embodiments, the expandable member is adjustable to conform to the shape of the rib bone to allow for a correct orientation of the rib bone.

A device for repairing a bone is provided and includes an expandable member releasably engaging a distal end of a delivery catheter having an inner lumen extending therethrough. Two or more clamps are configured to engage a rib bone and receive the expandable member such that the two or more clamps secure the expandable member to the rib bone. A light fiber can extend through the inner lumen into the expandable member to emit a light energy into the expandable member, and at least one reinforcing material can be curable by the light energy emitted from the light fiber. The expandable member is configured to move from a deflated state to an inflated state when the at least one reinforcing material is added into the expandable member to allow for a correct orientation of the rib bone.

In some embodiments, the two or more clamps include a posterior member and an anterior member. In some embodiments, the posterior member and the anterior member are movably connected to one another between an open position such that the clamp is configured to be positioned on the rib bone and a closed positioned such that the clamp is configured to secure to at least a portion of the rib bone. In some embodiments, the two or more clamps are shaped to receive the rib bone such that the two or more clamps extend around at least a portion of the rib bone. In some embodiments, the two or more clamps include at least one contact point on a surface of the two or more clamps that is configured to contact the rib bone such that the at least one contact point is configured to increase the grip of the two or more clamps on the rib bone.

In some embodiments, the inflation of the expandable member with the at least one reinforcing material is configured to be adjustable to allow the expandable member to conform to a shape of the rib bone.

A method of repairing a fractured bone is also described herein (not claimed), and can include positioning two or more clamps on a fractured rib bone. The two or more clamps can include an opening configured to receive a portion of an expandable member therethrough to secure the expandable member to the fractured rib bone. The expandable member, releasably engaging a delivery catheter, can be passed through the opening of the two or more clamps, and the delivery catheter can have an inner void for passing of a light sensitive liquid to the expandable member and an inner lumen for passage of a light fiber to the expandable member. The expandable member can be expanded by delivering the light sensitive liquid through the delivery catheter and into the expandable member. The expansion of the expandable member can be adjusted by altering the amount of the light sensitive liquid therein to allow for correct orientation of the rib bone. The light fiber can be inserted through the delivery catheter and into the expandable member to cure the light sensitive liquid within the expandable member.

The presently disclosed embodiments will be further explained with reference to the attached drawings, wherein like structures are referred to by like numerals throughout the several views.

While the above-identified drawings set forth presently disclosed embodiments, other examples are also contemplated, as noted in the discussion.

References to "embodiments" throughout the description which are not under the scope of the appended claims merely represent possible exemplary executions and are therefore not part of the present invention.

Medical devices and methods (the methods not forming part of the present invention) for repairing bones are provided. The devices disclosed herein act as internal bone fixation devices and can include a delivery catheter terminating in a releasable expandable member. During a procedure for repairing a fractured bone, such as a rib bone, the expandable member is placed along a length of a fractured bone in a deflated state. Once in place, the expandable member is expanded from a deflated state to an inflated state by the addition of at least one light-sensitive material/reinforcing material. The at least one reinforcing material is subsequently hardened within the expandable member using a light source. The hardened expandable member can be released from the delivery catheter and sealed to enclose the at least one reinforcing material within the expandable member. The hardened expandable member remains along the fractured bone and can provide support and proper orientation of the fractured bone resulting in the repair, healing, and strengthening of die fractured bone.

The term "bone" as used herein generally refers to elongated and flat bones. The bones include, without limitation, the ribs, the femur, tibia, and fibula of the leg, the humerus, radius, and ulna of the arm, metacarpals and metatarsals of the hands and feet, the phalanges of the fingers and toes, collar bone, the spanning or joining of the wrist, the mandible, pelvis, and spine (i.e., vertebrae). The devices of the present disclosure are suitable for repairing various bones, including those listed above. In some embodiments, the devices are used in a surgical rib fixation procedure. In some embodiments, the devices are used in an external fixation procedure for bones. In some embodiments, the devices of the present disclosure are used to treat a fractured or weakened bone.

As used herein, the terms "fracture" or "fractured bone" refer to a partial or complete break in the continuity of a bone. The fracture can occur, for example, from an outside force or from a controlled surgical cut (osteotomy). The presently disclosed embodiments can be used to treat any type of bone fracture, including, but not limited to, a displaced fracture, a non-displaced fracture, an open fracture, a closed fracture, a hairline fracture, a compound fracture, a simple fracture, a multi-fragment fracture, a comminuted fracture, an avulsion fracture, a buckle fracture, a compacted fracture, a stress fracture, a compression fracture, spiral fracture, butterfly fracture, other fractures as described by AO Foundation coding, multiple fractures in a bone, and other types of fractures.

As used herein, the term "weakened bone" refers to a bone with a propensity toward a fracture due to a decreased strength or stability due to a disease or trauma. Some bone diseases that weaken the bones include, but are not limited to, osteoporosis, achondroplasia, bone cancer, fibrodysplasia ossificans progressiva, fibrous dysplasia, legg calve perthes disease, myeloma, osteogenesis imperfecta, osteomyelitis, osteopenia, osteoporosis, Paget's disease, and scoliosis. Weakened bones are more susceptible to fracture, and treatment to prevent bone fractures may be desirable.

<FIG> is a cross-sectional illustration of a rib <NUM>, which includes anterior and posterior (i.e., front and back) surfaces <NUM> and <NUM>, respectively, superior and inferior (i.e., top and bottom) surfaces <NUM>, <NUM>, respectively, and a coastal groove <NUM> formed in the posterior surface <NUM> proximate the inferior surface <NUM>. The rib <NUM> has an outer portion comprising compact bone, and an inner portion (i.e., intramedullary canal) comprising bone marrow (i.e., hematopoietic tissue).

The system of the present disclosure includes a photodynamic support member <NUM> (see <FIG>). In some embodiments, the photodynamic support member <NUM> is sufficiently designed to extend along a dimension of a bone being repaired.

The photodynamic support member <NUM> is formed in any suitable manner. For example, as is described in detail below, the photodynamic support member <NUM> is formed by filling an expandable member <NUM>, such as a balloon, with a photodynamic (light-curable) liquid <NUM> and exposing the photodynamic (light-curable) liquid <NUM> to an appropriate frequency of light and intensity to cure the photodynamic liquid <NUM> inside the expandable member <NUM> to form a rigid structure that extends along a bone to be repaired, such as a fractured rib (see <FIG>).

<FIG> in conjunction with <FIG> and <FIG> show schematic illustrations of an embodiment of a bone implant system <NUM> for formation and implantation of the photodynamic support member <NUM>. In some embodiments, the system <NUM> includes a light source <NUM>, a light pipe <NUM>, an attachment system <NUM> and a light-conducting fiber <NUM>. The attachment system <NUM> communicates light energy from the light source <NUM> to the light-conducting fiber <NUM>. In some embodiments, the light source <NUM> emits frequency that corresponds to a band in the vicinity of <NUM> to <NUM>, the visible spectrum. In some embodiments, the light source <NUM> emits frequency that corresponds to a band in the vicinity of <NUM> to <NUM>. In some embodiments, the light source <NUM> emits frequency that corresponds to a band in the vicinity of <NUM> to <NUM>. The system <NUM> further includes a flexible delivery catheter <NUM> having a proximal end that includes at least two ports and a distal end terminating in an expandable member <NUM> (e.g., a balloon). In some embodiments, the expandable member <NUM> is manufactured from a non-compliant (non-stretch / non-expansion) conformable material. In some embodiments, the expandable member <NUM> is manufactured from a conformable compliant material that is limited in dimensional change by embedded fibers. Optionally, in some embodiments, one or more radiopaque markers, bands or beads can be placed at various locations along the expandable member <NUM> and/or the flexible delivery catheter <NUM> so that components of the system <NUM> can be viewed using fluoroscopy.

In some embodiments, the system <NUM> includes one or more ports. In the embodiment shown in <FIG>, a proximal end of the catheter <NUM> includes two ports. One of the ports can accept, for example, the light-conducting fiber <NUM>. The other port can accept, for example, a syringe <NUM> housing a light-sensitive liquid <NUM>. In some embodiments, the syringe <NUM> maintains a low pressure during the infusion and aspiration of the light-sensitive liquid <NUM>. In some embodiments, the syringe <NUM> maintains a low pressure of about <NUM> atmospheres or less during the infusion and aspiration of the light-sensitive liquid <NUM>. In some embodiments, the light-sensitive liquid <NUM> is a photodynamic (light-curable) monomer. In some embodiments, the photodynamic (light-curable) monomer is exposed to an appropriate frequency of light and intensity to cure the monomer inside the expandable member <NUM> and form a rigid structure. In some embodiments, the photodynamic (light-curable) monomer <NUM> is exposed to electromagnetic spectrum that is visible (frequency that corresponds to a band in the vicinity of <NUM> to <NUM>). In some embodiments, the photodynamic (light-curable) monomer <NUM> is radiolucent, which permit x-rays to pass through the photodynamic (light-curable) monomer <NUM>.

As illustrated in <FIG>, the flexible delivery catheter <NUM> includes an inner void <NUM> for passage of the light-sensitive liquid <NUM>, and an inner lumen <NUM> for passage of the light-conducting fiber <NUM>. In the embodiment illustrated, the inner lumen <NUM> and the inner void <NUM> are concentric to one another. The light-sensitive liquid <NUM> has a low viscosity or low resistance to flow, to facilitate the delivery of the light-sensitive liquid <NUM> through the inner void <NUM>. In some embodiments, the light-sensitive liquid <NUM> has a viscosity of about <NUM> cP or less. In some embodiments, the light-sensitive liquid <NUM> has a viscosity ranging from about <NUM> cP to about <NUM> cP. The expandable member <NUM> may be inflated, trial fit and adjusted as many times as a user wants with the light-sensitive liquid <NUM>, up until the light source <NUM> is activated, when the polymerization process is initiated. Because the light-sensitive liquid <NUM> has a liquid consistency and is viscous, the light-sensitive liquid <NUM> may be delivered using low pressure delivery and highpressure delivery is not required, but may be used.

In reference to <FIG>, in some embodiments, the expandable member <NUM> can include an inner lumen in fluid connection with the inner lumen <NUM> of the delivery catheter <NUM>. In this manner, the light conducting fiber <NUM> can be passed into the expandable member <NUM>. The inner lumen <NUM> of the expandable member <NUM> may be an extension of the inner lumen <NUM> of the delivery catheter or may be a separate tube in fluid communication with the inner lumen <NUM> of the delivery catheter.

Light Cured Materials (LCMs) utilize energy provided by light, for example ultraviolet (UV) or visible light, to cure. Being very energetic, UV light can break chemical bonds, making molecules unusually reactive or ionizing them, in general changing their mutual behavior. In an embodiment, a light emitted by a light source reacts with a photoinitiator sensitive to UV light or visible light. Photoinitiators provide important curing mechanisms for addition polymerization.

Using a UV light, the reinforcing material ensures there is no or minimal thermal egress and that the thermal egress may not be long in duration. More specifically, there is no chemical composition or mixing of materials. The introduction of light starts the photoinitiator and the glue hardens. Once the light is introduced, the material inside the balloon hardens and the materials inside are affixed in place. Until the light is introduced, the bone placement is not disturbed or rushed as there is no hardening of a glue until the light is introduced, the balloon may be inflated or deflated due to the viscosity of the glue. The glue can be infused or removed from the balloon due to the low viscosity of the material. In some embodiments, the viscosity of the reinforcing material is less than approximately <NUM> cP. Not all embodiments are intended to be limited in this respect and some embodiments may include reinforcing materials having a viscosity exactly equal to or greater than <NUM> cP.

Different light cured materials use photoinitiators sensitive to different ranges of UV and visible light. For example, visible blue light may be useful to the curing process as it allows materials to be cured between substrates that block UV light but transmit visible light (e.g., plastics). Visible light increases the cure speed of light cured materials since a greater portion of the electromagnetic spectrum is available as useful energy. Further, visible light penetrates through light cured materials to a greater depth-enhancing cure depth. The light cured materials cure in such a way that is sufficient to hold a bone in the correct orientation. More specifically, the ability to inflate, set, adjust, orient bones, and the resulting union of the bone are available prior to hardening the glue.

In some embodiments, a contrast material can be added to the light-sensitive liquid <NUM> without significantly increasing the viscosity. Contrast materials include, but are not limited to, barium sulfate, tantalum, or other contrast materials known in the art. The light-sensitive liquid <NUM> can be introduced into the proximal end of the flexible delivery catheter <NUM> and passes within the inner void <NUM> of the flexible delivery catheter <NUM> up into an inner cavity <NUM> of the expandable member <NUM> to change a thickness of the expandable member <NUM> without changing a width or depth of the expandable member <NUM>. In some embodiments, the light-sensitive liquid <NUM> is delivered under low pressure via the syringe <NUM> attached to the port. The light-sensitive liquid <NUM> can be aspirated and reinfused as necessary, allowing for thickness adjustments to the expandable member <NUM> prior to activating the light source <NUM> and converting the liquid monomer <NUM> into a hard polymer.

In some embodiments, the light-sensitive liquid can be provided as a unit dose. As used herein, the term "unit dose" is intended to mean an effective amount of light-sensitive liquid adequate for a single session. By way of a non-limiting example, a unit dose of a light-sensitive liquid of the present disclosure for expanding the expandable member <NUM> may be defined as enough light-sensitive liquid to expand the expandable member <NUM> to a desired shape and size. The desired shape and size of the expandable member <NUM> may vary somewhat from patient to patient. Thus, a user using a unit dose may have excess light-sensitive liquid left over. It is desirable to provide sufficient amount of light-sensitive liquid to accommodate even the above-average patient. In some embodiments, a unit dose of a light-sensitive liquid of the present disclosure is contained within a container. In some embodiments, a unit dose of a light-sensitive liquid of the present disclosure is contained in an ampoule. In some embodiments, the expandable member <NUM> is sufficiently shaped and sized to extend along a dimension (e.g., the length) of a fractured bone, or at least portion thereof. In some embodiments, the light-sensitive liquid can be delivered under low pressure via a standard syringe attached to the port.

As illustrated in <FIG> in conjunction with <FIG>, the light-conducting fiber <NUM> can be introduced into the proximal end of the flexible delivery catheter <NUM> and passes within the inner lumen <NUM> of the flexible delivery catheter <NUM> up into the expandable member <NUM>. The light-conducting fiber <NUM> is used in accordance to communicate energy in the form of light from the light source to the remote location. The light-sensitive liquid <NUM> remains a liquid monomer until activated by the light-conducting fiber <NUM> (cures on demand). Radiant energy from the light source <NUM> is absorbed and converted to chemical energy to polymerize the monomer. The light-sensitive liquid <NUM>, once exposed to the correct frequency light and intensity, is converted into a hard polymer, resulting in a rigid structure or photodynamic support member of the present disclosure. In some embodiments, the monomer <NUM> cures in about five seconds to about five minutes. This cure affixes the expandable member <NUM> in an expanded shape to form a photodynamic implant of the present disclosure. A cure may refer to any chemical, physical, and/or mechanical transformation that allows a composition to progress from a form (e.g., flowable form) that allows it to be delivered through the inner void <NUM> in the flexible delivery catheter <NUM>, into a more permanent (e.g., cured) form for final use in vivo. For example, "curable" may refer to uncured light-sensitive liquid <NUM>, having the potential to be cured in vivo (as by catalysis or the application of a suitable energy source), as well as to a light-sensitive liquid <NUM> in the process of curing (e.g., a composition formed at the time of delivery by the concurrent mixing of a plurality of composition components). The inner lumen of the delivery catheter can engage the expandable member for permitting a light fiber to extend through the inner lumen into the expandable member to guide light energy into the expandable member to cure at least one light sensitive liquid, or reinforcing material, curable by the light energy while minimizing thermal egress of the light energy to surrounding tissue from the expandable member.

Light-conducting fibers use a construction of concentric layers for optical and mechanical advantages. The light-conducting fiber can be made from any material, such as glass, silicon, silica glass, quartz, sapphire, plastic, combinations of materials, or any other material, and may have any diameter, as not all embodiments of the present disclosure are intended to be limited in this respect. In some embodiments, the light-conducting fiber is made from a polymethyl methacrylate core with a transparent polymer cladding. The light-conducting fiber can have a diameter between approximately <NUM> and approximately <NUM>. In some embodiments, the light-conducting fiber can have a diameter of about <NUM>, about <NUM>, about <NUM>, about <NUM>, less than about <NUM> or greater than about <NUM> as not all embodiments of the present disclosure are intended to be limited in this respect. In some embodiments, the light-conducting fiber is made from a polymethyl methacrylate core with a transparent polymer cladding. It should be appreciated that the above-described characteristics and properties of the light-conducting fibers are exemplary and not all embodiments of the present disclosure are intended to be limited in these respects. Light energy from a visible emitting light source can be transmitted by the light-conducting fiber. Various wavelengths of light can be to cure the liquid inside the expandable member. In some embodiments, visible light having a wavelength spectrum of between about <NUM> to about <NUM>, between about <NUM> to about <NUM>, between about <NUM> to about <NUM>, between about <NUM> to about <NUM>, is used to cure the light-sensitive liquid.

The most basic function of a fiber is to guide light, i.e., to keep light concentrated over longer propagation distances - despite the natural tendency of light beams to diverge, and possibly even under conditions of strong bending. In the simple case of a step-index fiber, this guidance is achieved by creating a region with increased refractive index around the fiber axis, called the fiber core, which is surrounded by the cladding. The cladding may be protected with a polymer coating. Light is kept in the "core" of the light-conducting fiber by total internal reflection. Cladding keeps light traveling down the length of the fiber to a destination. In some instances, it is desirable to conduct electromagnetic waves along a single guide and extract light along a given length of the guide's distal end rather than only at the guide's terminating face.

In some embodiments, at least a portion of a length of a light-conducting fiber is modified, e.g., by removing the cladding, in order to alter the profile of light exuded from the light-conducting fiber. The term "profile of light" refers to, without limitation, direction, propagation, amount, intensity, angle of incidence, uniformity, distribution of light and combinations thereof. In some embodiments, the light-conducting fiber emits light radially in a uniform manner, such as, for example, with uniform intensity, along a length of the light-conducting fiber in addition to or instead of emitting light from its terminal end/tip. To that end, all or part of the cladding along the length of the light-conducting fiber may be removed. It should be noted that the term "removing cladding" includes taking away the cladding entirely to expose the light-conducting fiber as well as reducing the thickness of the cladding. In addition, the term "removing cladding" includes forming an opening, such as a cut, a notch, or a hole, through the cladding. In some embodiments, removing all or part of the cladding can alter the propagation of light along the light-conducting fiber. In some embodiments, removing all or part of the cladding can alter the direction and angle of incidence of light exuded from the light-conducting fiber.

The cladding can be removed using a variety of techniques. In some embodiments, the cladding is removed by making a plurality of cuts in the cladding to expose the core of the light-conducting fiber. In some embodiments, the cladding is removed in a spiral fashion. In some embodiments, the cladding is removed in such a way that a similar amount of light is exuded along the length of the modified section of the light-conducting fiber. In some embodiments, the cladding is removed in such a way that the amount of light exuded along the length of the modified section of the light-conducting fiber changes from the distal end to the proximal end of the modified section. In some embodiments, the cladding is removed in such a way that the amount of light exuded along the modified section of the light-conducting fiber decreases from the distal end of the modified section of the light-conducting fiber toward the proximal end thereof. In some embodiments, to alter the profile of the light exuded from the modified section, the cuts in the cladding are located along the length of the fiber in a spiral. In some embodiments, the pitch or spacing between the cuts is varied along the length of the modified section of the light-conducting fiber. In some embodiments, the spacing between the cuts increases from the proximal end of the modified section of the light-conducting fiber <NUM> to the distal end thereof such that the amount of light exuded from the modified section of the light-conducting fiber progressively increases toward the distal end of the modified section of the light-conducting fiber.

In some embodiments, the light conducting fiber <NUM> is part of the delivery catheter <NUM> or separately placed in the delivery catheter <NUM>. In some embodiments, the light conducting fiber <NUM> is part of the expandable member <NUM>, or the light conducting fiber <NUM> is a separate component that is placed in the expandable member <NUM> before or after the expandable member <NUM> is secured to the bone.

The size and shape of the expandable member <NUM> can vary and can determined by a variety of factors, including but not limited to the anatomy of the bone to be repaired, characteristics of the fracture or other injury to the bone, or both. Suitable shapes include, but are not limited to, tubular, round, flat, cylindrical, dog bone, barbell, tapered, oval, conical, spherical, square, rectangular, toroidal and combinations thereof. In some embodiments, the expandable member <NUM> is tubular or cone shaped having a substantially centerline opening extending for a length of the expandable member. In some embodiments, the expandable member <NUM> has a diameter of <NUM> or smaller. In various embodiments, the expandable member <NUM> has a length of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM>. In some embodiments, the expandable member <NUM> can be longer than necessary to repair the fracture rib, and any excess material can be cut off of the photodynamic support member <NUM> after it has been formed by (i.e., after curing the light-sensitive liquid <NUM> infused into the expandable member <NUM>).

The materials forming the expandable member can also vary and have a variety of features. In some embodiments, the external surface of the expandable member <NUM> is resilient and puncture resistant. The expandable member <NUM> can be manufactured from a non-compliant (non-stretch / non-expansion) conformable material including, but not limited to urethane, polyethylene terephthalate (PET), nylon elastomer and other similar polymers. In some embodiments, the expandable member <NUM> is manufactured from a polyethylene terephthalate (PET). In some embodiments, the expandable member <NUM> is manufactured from a radiolucent material, which permit x-rays to pass through the expandable member <NUM>. In some embodiments, the expandable member <NUM> is manufactured from a radiolucent polyethylene terephthalate (PET). In some embodiments, the expandable member <NUM> is manufactured from a conformable compliant material that is limited in dimensional change by embedded fibers. In some embodiments, at least a portion of the external surface of the expandable member <NUM> is substantially even and smooth.

Optionally, the expandable member can include surface features on an outer surface of the expandable member. <FIG> illustrates an exemplary embodiment of an expandable member <NUM> with one or more surface features <NUM> on a surface thereof. The surface features can take a variety of forms. In some embodiments, at least a portion of the external surface of the expandable member <NUM> includes at least one textured element such as a bump, a ridge, a rib, an indentation or any other shape. In some embodiments, at least a portion of the external surface of the expandable member <NUM> protrudes out to form a textured element. In some embodiments, at least a portion of the external surface of the expandable member <NUM> invaginates to form a textured element. In some embodiments, the textured element increases the friction and improves the grip and stability of the expandable member <NUM> after the expandable member <NUM> is positioned on and affixed to the bone by the fracture location. In some embodiments, the textured element results in increased interdigitation of bone-device interface as compared to an expandable member without textured elements. In some embodiments, the textured element can be convex in shape. In some embodiments, the textured element can be concave in shape. In some embodiments, the textured element can be circumferential around the width of the expandable member <NUM>, either completely or partially.

In some embodiments, the expandable member <NUM> can include an external surface that may be coated with materials including, but not limited to, drugs (for example, antibiotics), proteins (for example, growth factors) or other natural or synthetic additives (for example, radiopaque or ultrasonically active materials). For example, after a surgical procedure an infection may develop in a patient, requiring the patient to undergo antibiotic treatment. An antibiotic drug may be added to the external surface of the expandable member <NUM> to prevent or combat a possible infection. Proteins, such as, for example, bone morphogenic protein or other growth factors have been shown to induce the formation of cartilage and bone. A growth factor can be added to the external surface of the expandable member <NUM> to help induce the formation of new bone. Due to the lack of thermal egress of the light-sensitive liquid <NUM> in the expandable member <NUM>, the effectiveness and stability of the coating is maintained.

In some embodiments, the expandable member <NUM> is free of any valves. One benefit of having no valves is that the expandable member <NUM> can be expanded or reduced in size as many times as necessary to assist in the fracture reduction and placement. Another benefit of the expandable member <NUM> having no valves is the efficacy and safety of the system <NUM>. Since there is no communication passage of light-sensitive liquid <NUM> to the body there cannot be any leakage of the light-sensitive liquid <NUM> because all the light-sensitive liquid <NUM> is contained within the expandable member <NUM>. In some embodiments, a permanent seal is created between the expandable member <NUM> and the delivery catheter <NUM> that is both hardened and affixed prior to the delivery catheter <NUM> being removed.

In some embodiments, abrasively treating the external surface of the expandable member <NUM>, for example, by chemical etching or air propelled abrasive media, improves the connection and adhesion between the external surface of the expandable member <NUM> and a bone surface. The surfacing significantly increases the amount of surface area that comes in contact with the bone which can result in a stronger grip.

The expandable member <NUM> can be infused with light-sensitive liquid <NUM> and the light-sensitive liquid <NUM> can be cured to form a photodynamic support member <NUM>, which can then be separated from the delivery catheter <NUM>.

In some embodiments, a separation area is located at the junction between the distal end of the expandable member <NUM> and the delivery catheter <NUM> to facilitate the release of the photodynamic support member <NUM> from the delivery catheter <NUM>. The separation area ensures that there are no leaks of reinforcing material from the elongated shaft of the delivery catheter and/or the photodynamic support member <NUM>. The separation area seals the photodynamic support member <NUM> and removes the elongated shaft of the delivery catheter by making a break at a known or predetermined site (e.g., a separation area). The separation area may be various lengths and up to about an inch long. The separation area may also have a stress concentrator, such as a notch, groove, channel or similar structure that concentrates stress in the separation area. The stress concentrator can also be an area of reduced radial cross section of cured light-sensitive liquid inside a contiguous cross-sectional catheter to facilitate separation by the application of longitudinal force. The stress concentrator is designed to ensure that the photodynamic support member <NUM> is separated from the delivery catheter <NUM> at the separation area. When tension is applied to the delivery catheter <NUM>, the photodynamic support member <NUM> separates from the shaft of the delivery catheter <NUM>, substantially at the location of the stress concentrator. The tension creates a sufficient mechanical force to preferentially break the cured material and catheter composite and create a clean separation of the photodynamic implant/shaft interface. It should of course be understood that the photodynamic support member <NUM> may be separated from the delivery catheter <NUM> by any other means known and used in the art, including radial twisting, shear impact, and cross-sectional cutting.

In some embodiments, the shape of the photodynamic support member <NUM> generally corresponds to the shape of the expandable member <NUM>. Modification of light-sensitive liquid <NUM> infusion allows a user to adjust the span or thickness of the expandable member <NUM> to provide specific photodynamic support member <NUM> size and shape to each subject. In that the expandable member <NUM> is formable and shapeable by the user prior to the photocuring of the light-sensitive liquid <NUM> in the expandable member <NUM>, the photodynamic support member <NUM> best mirrors the size and shape of the area (i.e., of the rib <NUM> or other bone to be repaired) onto which it is affixed. In some embodiments, the size and shape of the final photodynamic support member attempts to maximize the surface contact area with the bone, minimizing specific points of concentrated pressure. In some embodiments, the size and shape of the photodynamic support member <NUM> attempts to maximize the surface contact area with the bone, minimizing specific points of concentrated pressure.

The photodynamic support member <NUM> is secured to the rib <NUM> by two or more clamps that are configured to receive the expandable member <NUM>, as further discussed below.

<FIG> illustrates an embodiment of a clamp, or clip, <NUM> that can be used to receive an expandable member and secure the expandable member to a bone, such as a rib bone. <FIG> illustrates an embodiment of the clamp <NUM> affixed to a fractured rib <NUM> in accordance with the system of the present disclosure. The clamp <NUM> is designed to circumferentially engage the rib <NUM> via an interference fit and/or compression fit.

In some embodiments, the clamp <NUM> is constructed of one piece of material. In other embodiments, the clamp <NUM> is formed from two or more pieces of material. In various embodiments, the material(s) is any biologically acceptable material, including, without limitation, a ceramic, plastic (polymer), metal or alloy. Suitable plastics/polymers include polyether ether ketone (PEEK), ultra-high molecular weight polyethylene (UHMW-PE), polypropylene (PP), polyethylene (PE) and polymethylmetacrylate (PMMA). Suitable metals and metal alloys include, but are not limited to, Nb, Zr, Ti, Ta, Co, V, Cr, Al, alloys thereof, stainless steel, cobalt chrome and combinations thereof. Suitable ceramic materials include, but are not limited to, alumina, zirconia, chromium carbide, chromium nitride, silicon carbide, silicon nitride, titanium carbide, zirconium carbide, zirconium nitride, tantalum carbide, tungsten carbide, and any combination thereof.

In some embodiments, the clamp <NUM> is made from a radiolucent material, in order to eliminate scatter or other artifacts created during radiographic imaging of the rib or other bones (e.g., via x-ray, MRI, CT scan, etc.).

In some embodiments, the clamp <NUM> is configured to be placed on the anterior surface <NUM> of the rib <NUM>. In some embodiments, the clamp <NUM> is configured to engage the posterior surface <NUM> and/or the costal groove <NUM> of the rib <NUM>.

As illustrated in <FIG> and <FIG>, the clamp <NUM> includes a plate, or base, <NUM> having an anterior surface 210a and a posterior surface 210b that is configured to lie along the anterior surface <NUM> of the rib <NUM>. In some embodiments, the posterior surface 210b is formed from or lined with a soft material that is compressive (i.e., allows for surface compression) and thereby enhances contact with the anterior surface <NUM> of the rib <NUM> and increases stability.

A ring member <NUM> extends outwardly from the anterior surface 210a of the plate <NUM>, and defines an opening <NUM>. The ring member <NUM> and opening <NUM> are sized to receive the expandable member <NUM> therein, as further discussed below.

The clamp <NUM> further includes an anterior member <NUM> and a posterior member <NUM> that cooperate to enclose the rib <NUM>, plate <NUM> and ring member <NUM> therein. In some embodiments, the anterior member <NUM> includes two arcuate members 216a, 216b, which are arranged on either side of the ring member <NUM>. This configuration and other configurations of the clamp <NUM> facilitate more significant engagement with/on the superior surface <NUM> / posterior surface <NUM> of the rib <NUM>, to protect the blood vessels and nerves that are close to/run along the inferior surface <NUM> of the rib <NUM> (e.g., blood vessels within the costal groove <NUM>) by minimizing contact with these blood vessels and nerves.

The anterior and posterior members <NUM>, <NUM> cooperate to form a top portion <NUM> of the clamp <NUM> and a bottom portion <NUM> of the clamp <NUM>. The top portion <NUM> is configured to engage the superior surface <NUM> of the rib <NUM>, while the bottom portion <NUM> is configured to engage the costal groove <NUM> and inferior surface <NUM> of the rib <NUM>.

In some embodiments, the anterior and posterior members <NUM>, <NUM> are rotatably and/or pivotally connected to each other to allow the top portion <NUM> of the clamp <NUM> to rotate or pivot relative to the bottom portion of the clamp <NUM>. Any suitable connection between the top portion and the bottom portion can be used to achieve this relative motion, such as with one or more hinges or pivot points (not shown). In some embodiments, the anterior and posterior members <NUM>, <NUM> are releaseably connected to each other to form the bottom portion <NUM>. Any methods of attachment known in the art and suitable for attaching medical device components can be utilized. The anterior and posterior members <NUM>, <NUM> can include various fasteners to releaseably connect to each other, including, but not limited to, clips, pins, cooperating serrated teeth/slots, hinges and one or more screws. In some embodiments, a screw assembly with a radial dial having a varied tapered wedge (not shown) can be used that can be rotated to draw the anterior and posterior members <NUM>, <NUM> closer to each other. In some embodiments, the anterior and posterior members <NUM>, <NUM> are affixed to each other via a spring-loaded connection. In some embodiments, the clamp <NUM> includes a cam action bar (not shown) operably attached to the anterior and posterior members <NUM>, <NUM>, by which clamp <NUM> can be secured to the rib <NUM>, and by which the expandable member <NUM> can be secured (i.e., locked) within the opening <NUM> of the ring member <NUM>.

In some embodiments, at least the bottom portion <NUM> of the clamp <NUM> has a low profile, to avoid contact and/or interference with nearby anatomical structures, including the nerve residing within the costal groove and nearby blood vessels (i.e., arteries and veins). In some embodiments, the entire clamp <NUM> has a low profile, so as to be as close to the rib <NUM> as possible.

In some embodiments, the photodynamic support member <NUM> is secured under the anterior member <NUM> under implant <NUM>. The plate <NUM> can include one or more contact points, or pins <NUM>, that can contact the rib <NUM>, as shown in <FIG>, whereby deflection of the anterior member <NUM> pushes against the rib <NUM> to reinforce the fixation of the clamp <NUM> to the rib <NUM>. The one or more pins can provide additional grip between the rib bone and the clamp by increasing point contact force without substantially increasing compressive force against the bone.

<FIG> illustrates another exemplary embodiment of a clamp for receiving an expandable member. A clamp, as shown in <FIG>, is similar to the clamp <NUM> shown in <FIG> and <FIG>, but, unlike the clamp <NUM>, a clamp <NUM> shown in <FIG> includes a posterior member <NUM> that include first second arms <NUM>, <NUM> for receiving a posterior portion of the rib bone. The distance between the first and second arms <NUM>, <NUM> can vary as long as the distance between the first and second arms is sufficient to allow the posterior member of the clamp to be positioned on the rib bone as needed. For example, the distance between the first and second arms can vary based on the size of the bone to which the clamp is secured. It will be understood that the clamp can encircle the rib bone completed when secured thereto, or can go around the rib bone as much as needed to secure the clamp without encircling the entire bone.

<FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> illustrate another exemplary embodiment of a clamp <NUM> for receiving an expandable member that includes a posterior member <NUM> having a plate <NUM> with a posterior curved portion that is configured for contact with a surface of the rib. The curved portion of the plate <NUM> include a first arm <NUM> and a second arm <NUM> for receiving a posterior portion of the rib bone. An anterior portion of the posterior member <NUM> includes a ring member <NUM> that extend outwardly from an anterior surface of the posterior portion of the posterior member, and defines an opening <NUM>. The ring member <NUM> and the opening <NUM> are sized to receive an expandable member therein.

The clamp <NUM> includes an anterior member <NUM> that is curved and sized to be positioned around a portion of the posterior member such that a first end of the anterior member is positioned near the first arm of the posterior member and a second end of the anterior member is positioned near the second arm of the posterior member. The anterior member <NUM> can be pivotally coupled to the posterior member <NUM>. In some embodiments, as shown in <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG>, the anterior member is pivotally coupled to the posterior member at a pivot point <NUM> such the first end of the anterior member pivots relative to the first arm of the posterior member, as shown in <FIG>. The anterior member of the clamp is configured to provide additional structure by tightening the individual contact points between the clamp and bone, adding stability to the system. This allows all the components to be locked in place relative to each other and the bone for a stable and secure structure.

In some embodiments, the clamp <NUM> can include two cooperating components, as illustrated in <FIG>. A top (i.e., superior) member <NUM> is configured to engage and stabilize the rib <NUM> (not shown). A bottom (i.e., inferior) member <NUM> is configured to engage the rib <NUM> and secure and stabilize the photodynamic support member <NUM> in place on the rib <NUM>. In some embodiments, the bottom member <NUM> is curved to avoid the nerves and blood vessels in the proximity of the coastal groove. In some embodiments, the bottom member <NUM> includes a portion that is angled inwardly, towards the rib <NUM>, to apply tension to the rib <NUM> and secure the bottom member <NUM> to the rib <NUM> in a compression fit. In various embodiments, the ring member <NUM> can be positioned on the top member <NUM> or the bottom member <NUM>.

In some embodiments, the top and bottom members <NUM>, <NUM> are configured to engage each other and lock together to secure the rib <NUM> therebetween. Various mechanisms can be used to secure the top and bottom members of the clamp together. In some embodiments, the top member <NUM> includes a cam action hinge <NUM> (see <FIG>). The cam action hinge <NUM> includes a cam bar <NUM> that is used to modify the compression on the rib <NUM> that is generated by the top member <NUM>. For example, the cam bar <NUM> is moved towards the main body of the top member <NUM> to actuate the cam action hinge <NUM> and ultimately increase the compressive force exerted by the top member <NUM> (or a portion thereof) on the rib <NUM>. The cam action hinge <NUM> and cam bar <NUM> are thereby used to lock the clamp <NUM> in place on the rib <NUM>.

In some embodiments, the top and bottom members <NUM>, <NUM> include sets of locking serrated teeth <NUM>, <NUM>, respectively, that cooperate to secure the top and bottom members <NUM>, <NUM> together, as shown in <FIG>. In some embodiments, the top some embodiments and bottom members <NUM>, <NUM> include interlocking rails and/or male/female members that secure the top and bottom members <NUM>, <NUM> together (not shown).

The top and bottom members <NUM>, <NUM> are fabricated in multiple sizes, to facilitate a proper fit onto the rib <NUM>. For example, the top member <NUM> may be fabricated with different widths (e.g., <NUM> and <NUM>) to accommodate ribs have varied thickness. In various embodiments, the top and bottom members <NUM>, <NUM> have a combined height of <NUM>, <NUM>, <NUM>, <NUM> or <NUM> to accommodate various heights of ribs. In one embodiment, the top member <NUM>, or a portion thereof, can have a height that is approximately <NUM>% of the height of the rib <NUM>, to better stabilize the rib <NUM> when engaging same.

In some embodiments, the top and/or bottom members <NUM>, <NUM> include one or more bumps, or enlarged endpoints, <NUM>, <NUM>, respectively, as shown in <FIG>, and <FIG>. The bumps <NUM>, <NUM> assist in engaging the rib <NUM> and maintaining the top and/or bottom members <NUM>, <NUM> securely on the rib <NUM>. In some embodiments, the top and/or bottom members <NUM>, <NUM> can each have a single bump <NUM>, <NUM>. In some embodiments, the top and/or bottom members <NUM>, <NUM> can each have multiple bumps (not shown).

A kit for repairing a weakened or fractured bone can also be provided. A kit can include a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween and one or more expandable members, such as a balloon, designed to releasably engage the delivery catheter. One or more clamps can be provided for securing the expandable member to a fractured bone, such as a rib. The kit can also include at least one reinforcing material curable by light energy configured to pass through an inner void of the delivery catheter and into the expandable member. The expandable member can be configured to move from a deflated state to an inflated state when the reinforcing material is added. The reinforcing material can be cured by a light energy delivered through the catheter to the expandable member.

As discussed above, some embodiments of the system of the present disclosure include two or more of the clamps <NUM>, which are secured at intervals along the length of the rib <NUM> (or other bone) having a fracture <NUM>, as illustrated in <FIG>, <FIG>, <FIG> and <FIG>. After the clamps <NUM> have been secured to the rib <NUM> proximate the fracture <NUM>, the expandable member <NUM> is threaded through the openings <NUM> of the ring members <NUM>, as illustrated in <FIG>. It will be understood that any clamp can be used and secured to the rib to replace a rib fracture.

<FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, <FIG>, and <FIG> illustrate an example of method steps for repairing a fractured rib <NUM> using the photodynamic device <NUM>, expandable member <NUM> and any of the clamps, including clamps <NUM>, of the present disclosure.

A small incision is made through the skin of the patient's body (not shown), proximate the fractured rib <NUM> to be repaired. In some embodiments, an incision can be made following the linear line of the rib. As illustrated in <FIG>, the tunneling device <NUM> is introduced through the incision and moved between the rib <NUM> and the subcutaneous layer of skin <NUM> overlying same to dissect the subcutaneous layer <NUM> away from the rib <NUM> and create a space therebetween. The tunneling device <NUM> is designed to conform to the curvature of the rib <NUM>, thereby freeing up the surrounding tissues to expose the intercostal muscles.

In some embodiments, a guidewire <NUM> is used to pass the tunneling device <NUM> along the fractured rib <NUM> (see <FIG>). In some embodiments, the tunneling device <NUM> is passed from the posterior side of a patient to the anterior side of the patient (i.e., from a side of the patient's body, under their arm, towards the front of the patient's body). In some embodiments, the tunneling device <NUM> includes an illumination member (not shown) to facilitate visualization of the surrounding tissues, including the nearby blood vessels (i.e., arteries and veins).

Depending on the location and pattern of the fracture <NUM> on the rib <NUM>, a small skin incision is made anterior the rib <NUM> (not shown), and the tunneling device <NUM> is slightly retracted or withdrawn (e.g., ¾ inch). The guidewire <NUM> can then be removed from the tunneling device <NUM> (see <FIG>). The skin incision is opened, for example by using a small skin retractor (not shown), and a first one of the clamps <NUM> is positioned on the rib <NUM> (see <FIG>).

The clamp <NUM> is then affixed to the rib <NUM>, as illustrated in <FIG> and <FIG>. As discussed above, the top portion <NUM> of the clamp <NUM> engages the superior surface <NUM> of the rib <NUM>, and the bottom portion <NUM> engages the costal groove <NUM> and inferior surface <NUM> of the rib <NUM>. The clamp <NUM> is secured to the rib <NUM> via a compressive fit or interference fit, and tightened into position.

Once the clamp <NUM> is positioned, the guidewire <NUM>, is directed from the incision through the opening <NUM> of the ring member <NUM>. The guidewire <NUM> is used to move and position the expandable member <NUM> along the rib <NUM>, as further discussed below. The guidewire <NUM> is attached to a tip of the tunneling device <NUM>, which is then positioned at a point along the rib <NUM> where a second one of the clamps <NUM>' is to be affixed to the rib <NUM> (see <FIG>). A second small skin incision is made, and the tunneling device <NUM> is slightly retracted or withdrawn (e.g., ¾ inch). The guidewire <NUM> can then be removed from the tunneling device <NUM>. The second skin incision is opened, and the second clamp <NUM>' is positioned on and affixed to the rib <NUM>. The guidewire <NUM> is directed from the second incision through the opening <NUM> of the ring member <NUM> of the second clamp <NUM>' (see <FIG>). It will be understood that the guidewire is passed through each of the clamps positioned on the rib bone.

In some embodiments of the system, as in the case of small fractures, only two clamps <NUM>, <NUM>' are required - one clamp on each side of the fracture. More severe fractures require at least four clamps (e.g., two or more clamps on either side of the fracture) to provide adequate support.

In an embodiment having at least four of the clamps <NUM>, the guidewire <NUM> is then attached to a tip of the tunneling device <NUM>, which is then positioned at a point along the rib <NUM> where a third one of the clamps <NUM>" is to be affixed to the rib <NUM> (see <FIG>). A third small skin incision is made, and the tunneling device <NUM> is slightly retracted or withdrawn (e.g., ¾ inch). The guidewire <NUM> may then be removed from the tunneling device <NUM>. The third skin incision is opened, and the third clamp <NUM>" is positioned on and affixed to the rib <NUM>. The guidewire <NUM> is then directed from the third incision through the opening <NUM> of the ring member <NUM> of the third clamp <NUM>". This procedure is repeated to affix each additional clamp (e.g., a fourth clamp <NUM>'") to the rib <NUM> (see <FIG>).

Once the required number of clamps <NUM> are affixed to the rib <NUM>, the tunneling device <NUM> is removed, and the guidewire <NUM> running from the first clamp <NUM> to the last clamp (the clamp <NUM>‴ in <FIG>) through the respective ring members <NUM>/openings <NUM> is removed from the tunneling device <NUM> and left in place.

As illustrated in <FIG>, a sheath <NUM> and dilator <NUM> are then delivered over the guidewire <NUM> and directed in place through each of the respective ring members <NUM>/openings <NUM> of the clamps <NUM>. The dilator <NUM> and guidewire <NUM> are then removed, and the sheath <NUM> is left in place through the respective ring members <NUM>/openings <NUM> along the rib <NUM>.

The expandable member <NUM> is then introduced into the sheath <NUM> along the guidewire <NUM>, such that the expandable member <NUM> extends through the respective ring members <NUM>/openings <NUM> along the rib <NUM> within the sheath <NUM>, as illustrated in <FIG>. In this embodiment, the delivery catheter <NUM> is connected to the expandable member <NUM> at the distal end of the expandable member <NUM>. The sheath <NUM> is then removed (i.e., torn away), along with the guidewire <NUM>, and the expandable member <NUM> is inflated with the liquid monomer (i.e., the light-sensitive liquid <NUM>). As explained above, the light-sensitive liquid <NUM> is infused through the inner void in the delivery catheter <NUM> into the expandable member <NUM> to move the expandable member from a deflated state to an inflated state. The expandable member <NUM> assumes the shape and span/curvature of the rib <NUM>, and is cured in place (see <FIG>). More particularly, once the position of the expandable member <NUM> on the rib <NUM> is confirmed, the light-sensitive liquid <NUM> may be hardened within the expandable member <NUM>, such as by illumination with a visible emitting light source (not shown), to form the photodynamic support member <NUM> (see <FIG>), thereby providing longitudinal and rotational stability to the rib <NUM>. After the light-sensitive liquid has been hardened, the light source may be removed from the device. Alternatively, the light source can remain in the expandable member <NUM> to provide increased rigidity. The photodynamic support member <NUM> can then be released from the delivery catheter <NUM> by any known methods in the art.

In some examples, a larger incision can be used to expose one or more ribs and place two or more clamps thereon. This can be used in situations involving the fracture of multiple ribs, or when more than one fracture has occurred at various locations on one or more ribs.

In some examples, two or more clamps can be preplaced on the tunneling device. The tunneling device can be passed from the posterior side of a patient to the anterior side of the patient (i.e., delivered from the proximal aspect to the distal aspect of the patient) with the clamps removably attached thereto. The clamps can be applied to the rib as the tunneling device is pulled back from the distal aspect to the proximal aspect. Thus, after an incision is made, the clamp is attached to the rib starting at the distal-most clamp on the tunneling device. A second incision can be made to place the next clamp, and this can be repeated until all the clamps on the tunneling device are placed on the fractured bone.

In some embodiments, the photodynamic support member <NUM> can be formed with a plurality of expandable members, as shown in <FIG> and <FIG>, where each expandable member <NUM> can be inflated or deflated independently of other expandable members. The individual expandable members can be inflated or deflated as desired to adjust the position, angulation, alignment or combinations thereof of photodynamic support member <NUM>. In some embodiments, the use of more than one expandable member can increase the granularity of the adjustment of the support member relative to the fractured bone. It will be understood that any number of expandable members can be used, and that the two or more clamps through which the expandable members extend can be adjusted in size and/or shape to accommodate the one or more expandable members.

In some embodiments, the diameter of an expandable member, such as the expandable member <NUM> or the multiple expandable members <NUM> (<FIG>), is slighter larger than the diameter of the openings <NUM> of the ring members <NUM>, such that the expandable member will be locked into place within the openings <NUM>/ring members <NUM>, once it is expanded by the liquid monomer.

In some embodiments, the diameter of an expandable member, such as the expandable member <NUM>, is slightly smaller than the diameter of the openings <NUM>, and caps (not shown) are placed on the ends of the expandable member <NUM> to immobilize it within clamps, such as the clamps <NUM>.

In some embodiments, an expandable member, such as the expandable member <NUM>, functions as part of a compressive locking mechanism for a clamp, such as the clamps <NUM>. The compressive locking mechanism for each clamp <NUM> includes a handle (not shown) that engages the rib <NUM> in a closed/locked position by the presence of the expandable member <NUM> within the openings <NUM> of the ring members <NUM>. The handle/compressive locking mechanism can only be changed to an open/unlocked position (disengaging/releasing the rib <NUM>) when the expandable member <NUM> is removed from the openings <NUM> of the ring members <NUM>.

In some embodiments, the support member <NUM> is not photodynamic, but is formed as a metal rod (e.g., titanium or stainless steel) that is dimensioned to be secured along the bone to be repaired in the same or a similar manner as disclosed herein for the photodynamic support member <NUM>. In some embodiments, a compressible two-member assembly is used to hold the metal rod/support member in place along the rib or other bone. The two-member assembly can include two plates that sandwich the metal rod/support member therebetween. The ring members of the clamps are sized to receive the metal rod in these embodiments. Each ring member can include an end cap that covers the end of the metal rod. The cap is in the same plane (i.e., coplanar with) as the rib, and can be secured to the plate/base of the clamp.

Although the system is described in connection with the stabilization and repair of a fractured rib, the system and methods of the present disclosure can also be used in the external fixation in the repair of other fractured bones (not forming part of the present invention), including, without limitation, the femur, tibia, hips and fibula of the legs, the humerus, radius and ulna of the arms, metacarpal and metatarsal bones of the hands and feet, the phalanges of the fingers and toes, the clavicle, ankle, wrist, mandible, spinal articular surface bones including, but not limited to, the facet joint and the vertebral body, ribs, temporomandibular joint, and pelvis.

The system of the present disclosure can be utilized in the external fixation of a bone without requiring a rod or other member to be placed within the intramedullary canal.

The system of the present disclosure enables external fixation (e.g., a bone plate or rod) without the need to use screws to secure the external plate or rod to the bone. These screws penetrate and violate/damage the cortex of the bone. In contrast, the system of the present disclosure provides a rigid bar (or plate) that conforms to the external shape of the bone and is removably secured to the bone at multiple points with minimal contact.

As discussed above in connection with the rib fixation system, the external fixation system includes subcutaneous fixator components secured between the injured bone and the adjacent skin. The system is for temporary external fixation of an injured bone.

In some examples, the external fixation system can involve rods or other members that are secured to the injured bone via screws or other forms of fixation. The rods may have a variety of lengths, depending upon indication and fracture pattern. In various embodiments, the rods have lengths of <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM>. The rods can be made either longer or shorter, depending on various factors, including the specific indications, the location of the fracture and the type of fracture. It can be possible to use this fixation system in cooperation with the bone stabilization system having one or more expandable members as described above.

In some examples, the rods are threaded (i.e., screw posts or Shantz screws) that are driven into the bone at an ostensibly <NUM> degree angle to the longitudinal plane of the bone. These rods are delivered percutaneously into the bone, and terminate (i.e., have a terminal portion/end) that extends/rises above the skin surface (i.e., a plane defined by the skin surface) by some pre-determined distance (i.e., height). This distance/height depends on indication, and, in various embodiments, this distance/height is <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM>, <NUM> or <NUM>. Larger bones and transiting joints require larger distances/heights.

Multiple rods are delivered into the bone at points on either side of the fracture. The individual rods are then connected by connection rods, thereby fixing and stabilizing the span of bone along which the connection rods extend. Some embodiments of the rods also include fixation fittings, which are a form of capture device located on the terminal portions/ends of the rods so as to secure the rods/screw posts to the connection rods.

The use of a flexible connection member that becomes rigid according to this embodiment resolves/eliminates such alignment issues.

Circular attachments (e.g., rings) are provided proximate the rods for receiving an expandable member that may be formed into a rigid rod by curing, as discussed above in connection with the rib fixation system. The circular attachments/rings may be a circular capture device having two semi-circular "half c's" or other curved shapes and an inner compression screw or other means for capturing the inflatable rod.

Claim 1:
A bone fixation device comprising:
an expandable member (<NUM>) capable of moving from a deflated state to an inflated state by infusing at least one light sensitive liquid into the expandable member, the light sensitive liquid being configured to cure within the expandable member to harden the expandable member; and
two or more clamps (<NUM>) configured to engage a rib bone and receive the expandable member such that the two or more clamps secure the expandable member to the rib bone, the inflation of the expandable member with the at least one light sensitive liquid configured to be adjustable to conform to a shape of the rib bone,
characterised in that the bone fixation device further comprising
a ring member (<NUM>) extending outwardly from each of the two or more clamps, the ring member configured to have an opening that is sized to receive the expandable member therein.