US20130023876A1

US20130023876A1 - Combination Photodynamic Devices

Info

Publication number: US20130023876A1
Application number: US13/553,051
Authority: US
Inventors: Robert A. Rabiner; Richard Scott Rader
Original assignee: IlluminOss Medical Inc
Current assignee: IlluminOss Medical Inc
Priority date: 2011-07-19
Filing date: 2012-07-19
Publication date: 2013-01-24
Also published as: US20130023886A1; EP2734266A1; EP2734134A1; US11559343B2; US20130046390A1; US20230263561A1; CN103687645A; US10292823B2; GB2493100A; US9144442B2; EP2734133A1; EP2734133A4; JP2014533965A; US20190231533A1; US9775661B2; US11141207B2; EP2734266B1; BR112014001078A2; US20150374498A1; GB2493100B

Abstract

Combination photodynamic devices for repair and stabilization of a fractured or a weakened bone are disclosed herein. In an embodiment, a combination photodynamic device includes a load bearing member and one or more conformable members connected to the load bearing member, the conformable member expandable from a deflated state to an inflated state. The load bearing member is designed to reside inside a cavity of fractured or weakened bone and act as internal bone fixation and stabilization device. The conformable member is designed to anchor the load bearing member inside a bone cavity, transform the load bearing member from a flexible state to a rigid state, contribute to fixating and stabilizing a fractured or a weakened bone, and provide longitudinal and rotational stability to a fractured or a weakened bone during the healing process or combinations thereof.

Description

RELATED APPLICATIONS

This application claims the benefit of and priority to U.S. Provisional Patent Application No. 61/509,314, filed on Jul. 19, 2011, U.S. Provisional Patent Application No. 61/509,391, filed on Jul. 19, 2011, and U.S. Provisional Patent Application No. 61/509,459, filed on Jul. 19, 2011, the entirety of these applications are hereby incorporated herein by reference.

FIELD

The embodiments disclosed herein relate to bone implants, and more particularly to combination photodynamic devices for bone repair and stabilization.

BACKGROUND

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). A fracture's alignment is described as to whether the fracture fragments are displaced or in their normal anatomic position. In some instances, surgery may be required to re-align and stabilize the fractured bone. It is often difficult to properly position and stabilize fractured or weakened bones. It would be desirable to have an improved device for repairing and stabilizing a fractured or weakened bone.

SUMMARY

Combination photodynamic devices for repair and stabilization of a fractured or a weakened bone are disclosed herein. In one aspect, there is a provided a combination photodynamic device that includes at least one load bearing member designed to reside in a cavity of a fractured or weakened bone, and at least one conformable member connected to the at least one load bearing member. The at least one load bearing member acts as an internal bone fixation and stabilization device. The at least one conformable member is configured to be expandable from a deflated state to an inflated state to anchor the at least one load bearing member inside the cavity.
In one embodiment, the at least one conformable member is expandable from a deflated state to an inflated state using an expansion fluid. In an embodiment, the at least one conformable member is a balloon. In an embodiment, the at least one conformable member is designed to transform the at least one load bearing member from a flexible state for delivery to or removal from the cavity of the bone to a rigid state for implantation within the cavity of the bone. In an embodiment, the at least one conformable member is detachably or removably attached to the at least one load bearing member.
In an embodiment, the at least one load bearing member has a threaded end so that the at least one load bearing member can be screwed into the bone. In an embodiment, the at least one load bearing member is an elongated rod or an intramedullary nail. In an embodiment, the at least one load bearing member is made of a flexible material. In an embodiment, the at least one load bearing member includes a plurality of nested tubes telescopically slidable relative to one another. In an embodiment, the at least one load bearing member has a compressible body that can be transformed from a flexible state to a rigid state by a compressive force. In an embodiment, the at least one load bearing member is transformable between a flexible state and a rigid state by radially expanding the at least one load bearing member using the conformable member placed inside the load bearing member. In an embodiment, the at least one load bearing member is as at least partially enclosed by the at least one conformable member. In an embodiment, the at least one load bearing member is adjacent to the at least one conformable member. In an embodiment, the at least one load bearing member is a flexible patterned tube or a flexible helical spring, and the at least one conformable member is configured to be inserted in the at least one load bearing member and expanded to transform the at least one load bearing member to a rigid state.
In an embodiment, the device includes one or more holes in the at least one load bearing member and/or at least one conformable member for receiving one or more fasteners to secure the device to the bone. In an embodiment, the device includes a cam structure attached to the at least one load bearing member and configured to act upon the at least one conformable member to increase pressure between the at least one load bearing member containing the cam structure, the at least one conformable member, and/or the weakened or fractured bone to stabilize the load bearing member in the cavity of the bone. In an embodiment, the at least one load bearing member includes one or more segments.
In one aspect, a combination photodynamic device kit includes: at least one expansion fluid; a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween; a conformable member releasably engaged to the distal end of the delivery catheter and wherein the delivery catheter has an inner void for passing the at least one expansion fluid into the conformable member; and a load bearing member, wherein the load bearing member can be engaged with the conformable member. In an embodiment, the kit also includes a plurality of conformable members of different sizes or shapes.
In one aspect, a method for bone repair and stabilization includes: inserting a load bearing member into a cavity of a fractured or weakened bone; inserting one or more conformable members into the cavity; engaging the one or more conformable members with the load bearing member; and expanding the conformable member with an expansion fluid, thereby anchoring the load bearing member inside the cavity and providing longitudinal and rotational stability to the load bearing member during the healing process. In an embodiment, the load bearing member is flexible when inserted into the cavity, and becomes rigid upon expanding the conformable member with an expansion fluid.

BRIEF DESCRIPTION OF THE DRAWINGS

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. The drawings shown are not necessarily to scale, with emphasis instead generally being placed upon illustrating the principles of the presently disclosed embodiments.

FIG. 1A shows a schematic illustration of an embodiment of a combination photodynamic implant including a load bearing member and a conformable member.

FIG. 1B shows a schematic illustration of an embodiment of a combination photodynamic implant including multiple load bearing members.

FIG. 1C shows a schematic illustration of an embodiment of a combination photodynamic implant having a threaded end.

FIG. 2 shows a schematic illustration of an embodiment of a bone implant system. The system includes a light source, a light pipe, an attachment system, a light-conducting fiber, a light-sensitive liquid, a delivery catheter and a conformable member.

FIG. 3A and FIG. 3B show close-up cross-sectional views of the region circled in FIG. 2. FIG. 3A shows a cross-sectional view of a distal end of the delivery catheter and the conformable member prior to the device being infused with light-sensitive liquid. FIG. 3B shows a cross-sectional view of the distal end of the delivery catheter and the conformable member after the device has been infused with light-sensitive liquid and light energy from the light-conducting fiber is introduced into the delivery catheter and an inner lumen of the conformable member to cure the light-sensitive liquid.

FIG. 4A and FIG. 4B illustrate an embodiment of a combination photodynamic implant having a single-piece load bearing member.

FIG. 5A illustrates an embodiment of a combination photodynamic implant in which a load bearing member is made of a series of telescoping tubes.

FIG. 5B illustrates an embodiment of a combination photodynamic implant in which a load bearing member is a compressible body.

FIG. 5C and FIG. 5D illustrate an embodiment of a combination photodynamic implant in which a conformable member engages a load bearing member and provides interference in compression or tension to features of the load bearing member.

FIGS. 6A-6D illustrate an embodiment of a combination photodynamic implant in which a load bearing member is transformable from a flexible state to a rigid state by a conformable member or a portion thereof.

FIG. 7A and FIG. 7B illustrate an embodiment of a combination photodynamic implant in which a load bearing member is enclosed within a conformable member.

FIG. 8A and FIG. 8B illustrate an embodiment of a combination photodynamic implant including one or more conformable members.

FIG. 8C-8F illustrate embodiments of a combination photodynamic implant including an internal cam structure.

FIG. 8G and FIG. 8H illustrate an embodiment of a combination photodynamic implant including one or more conformable members.

FIG. 9A and FIG. 9B illustrate an embodiment of a combination photodynamic implant having a modular load bearing member.

FIGS. 10A-10F show an embodiment of method steps for using the systems and device.

While the above-identified drawings set forth presently disclosed embodiments, other embodiments are also contemplated, as noted in the discussion. This disclosure presents illustrative embodiments by way of representation and not limitation. Numerous other modifications and embodiments can be devised by those skilled in the art which fall within the scope and spirit of the principles of the presently disclosed embodiments.

DETAILED DESCRIPTION

Medical devices and methods for repairing and stabilizing a weakened or fractured bone are disclosed herein. As shown in FIG. 1A, a combination photodynamic device 100 of the present disclosure includes a load bearing member 115 and one or more conformable members 170 associated with the load bearing member 115. The term “associated with” as used herein means, either fixedly or removably, connected to, affixed to, incorporated into, linked with, attached to, wrapped around, inserted into, mounted over, received in, or any other physical connection. In an embodiment, the combination photodynamic device 100 can include multiple load bearing members 115a, 115b, as shown in FIG. 1B. The load bearing member 115 is designed to reside inside of a cavity 101 of a bone 105 and act as an internal bone fixation and stabilization device during the healing of a bone fracture 104. The terms “cavity within a bone” and “bone cavity” as used herein is intended to include both natural cavities within a bone, such as the intramedullary cavity, physician-created cavities, and also cavities created due to bone diseases. The conformable member 170 is designed to anchor the load bearing member 115 inside the bone cavity 101 and to provide longitudinal and rotational stability to the load bearing member 115 during the healing of the bone fracture 104. Additionally or alternatively, the conformable member 170 is designed to transform the load bearing member 115 from a flexible state for delivery to a bone cavity to a rigid state once inside the bone cavity inside the bone cavity 101. It should be noted that in some combination photodynamic implants of the present disclosure, the conformable member can also function to fixate and stabilize a fractured or weakened bone or to provide longitudinal and rotational stability to a fractured or weakened bone, either in combination with or independently of the load bearing member 115.
A combination photodynamic device may be used to treat a fractured or weakened bone. The combination photodynamic devices of the present disclosure are suitable to treat a fractured or weakened tibia, fibula, humerus, ulna, femur, radius, metatarsals, metacarpals, phalanx, phalanges, ribs, spine, vertebrae, clavicle, pelvis, wrist, mandible, and other bones and still be within the scope and spirit of the disclosed embodiments. In an embodiment, a combination photodynamic devices of the present disclosure is used to stabilize, reinforce or support a weakened bone. In an embodiment, a combination photodynamic devices of the present disclosure is used to stabilize a fractured bone in conjunction with anatomic reduction (i.e., proper reorientation of fractured elements to their original position, both relative to one another and relative to other adjacent anatomical features).
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). A combination photodynamic implant 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, multiple fractures in a bone, spiral fracture, butterfly fracture, other fractures as described by AO Foundation coding, 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.
In an embodiment, the combination photodynamic implant may be used to stabilizing fractured or weakened load bearing bones including, but not limited to, the femur and tibia bones of the leg. The use of the combination implant, in an embodiment, allows for strength of the load bearing member to be imparted through the use of metal or structural plastics like those listed above and other suitable materials. In an embodiment, use of the combination implant allows for minimally invasive placement since the load bearing member can be a small diameter but filling the internal cavity can be accomplished with the conformable member(s). In an embodiment, the combination implant can provide the required stability with potentially significant load carrying capacity increase due to the use of particular metal load bearing and photodynamic conformable members.
In an embodiment, the load bearing member 115 is sufficiently designed for implantation into a bone cavity via a minimally invasive method. The load bearing member 115 may be flexible or rigid. In an embodiment, the load bearing member 115 is in a flexible state for delivery to a bone cavity and is transformed to a rigid state once inside the bone cavity. In an embodiment, the load bearing member 115 is transformable from a flexible state to a rigid state by the conformable member 170. The load bearing member 115 can comprise a single piece or multiple pieces.
The load bearing member 115 can be made from a variety of biocompatible materials including, but not limited to, metal, composite, plastic or amorphous materials, which include, but are not limited to, steel, stainless steel, cobalt chromium plated steel, titanium, nickel titanium alloy (nitinol), superelastic alloy, and polymethylmethacrylate (PMMA), poly-ether ether ketone (PEEK), composite materials of polymers and minerals, composite materials of polymers and glass or polymeric fibers, composite materials of metal, polymer, and minerals and any other engineering materials.
Referring to FIG. 1B, when implanted within a bone cavity, in addition to being held in place with the one or more conformable members 170, the photodynamic implant 100 may further be held in place by any suitable fasteners 102, including, but not limited to, screws, pins, wires, nails, and bolts. In an embodiment, the load bearing member 115 may include one or more holes 104 for receiving fasteners 102 that can be inserted through the bone to secure the combination photodynamic implant 100 in place. In an embodiment, the holes 104 are located at the proximal and distal ends of the load bearing member 115. In an embodiment, the load bearing member 115 are made of a material into which fasteners 102 can be inserted without providing pre-drilled holes in the load bearing member 115, such as polyether ether ketone (PEEK). In such an embodiment, fasteners 102 can be inserted into the load bearing member 115 at a user selected location anywhere along a length of the load bearing member 115, at any angle and to any desired depth. A combination implant of a load bearing member 115 made of a material, such as PEEK, combined with a conformable member 170, allows user-selected insertion of fasteners 102 at any location along the implant, at any angle or desired depth, transiting any combination of bone, conformable member 170, and/or load bearing member 115 as desired by the user. Additionally or alternatively, in an embodiment, fasteners 102 can also be inserted into the conformable member 170 at a user selected location, at any angle and to any desired depth. Because the fasteners can be inserted at user-selected locations, the user is able to determine the optimal placement for fasteners based on each patient's specific situation rather than on the predrilled holes. In addition, flexible fastener placements simplifies the procedure by enabling the user to have a cross-locking screw without targeting to “find” pre-drilled holes.
In an embodiment, as shown in FIG. 1C, one end of the load bearing member 115 is adapted for insertion into a cortical bone. In an embodiment, the load bearing member includes a threaded end 103 such that the load bearing member 115 can be securely screwed into cortical bone. In an embodiment, the threaded end 103 of the load bearing member is tapered to facilitate insertion of the threaded end 103 into cortical bone.
In an embodiment, the conformable member 170 is a balloon expandable from a deflated state to an inflated state by the addition of at least one expansion fluid. Modification of expansion fluid infusion allows a user to adjust the size and shape of the conformable member 170 in its inflated state, as is described above. Because the shape and size of the conformable members 170 are easily configurable by the user, the conformable member 170 can be adjusted to achieve a conformal fit with the cavity into which the combination photodynamic implant 100 is implanted, thereby ensuring that the implanted combination photodynamic implant 100 is longitudinally and rotationally secured inside the bone cavity. In an embodiment, the conformable member 170 can be adjusted to conform to the internal diameter of the bone cavity into which the combination photodynamic implant 100 is implanted as well as the curvature of the bone cavity. In an embodiment, the conformable member 170 is adjusted to transform the load bearing member 115 from a flexible state to a rigid state. In an embodiment, the conformable member 170 is adjusted to facilitate fixation, stabilization, or both of the fractured or weakened bone into which it is inserted.
In an embodiment, the expansion fluid is a curable liquid, that is a liquid that can progress from a flowable form for delivery to the conformable member 170, such as, for example, through a catheter, to a non-flowable (e.g., cured) form for final use in vivo. A cure may refer to any chemical, physical, and/or mechanical transformation. In an embodiment, the expansion fluid is a light-sensitive liquid 165, which can be cured inside the conformable member 170 by exposing it to light energy, as is described in more detail below. The term “curable” may refer to uncured liquid, having the potential to be cured in vivo (as by catalysis or the application of a suitable energy source), as well as to a liquid 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). Curing the curable expansion fluid inside the conformable member 170 affixes the conformable member 170 in an expanded shape to form a photodynamic implant. It should be understood that a photodynamic implant will have the size and shape substantially similar to a conformable member from which the photodynamic implant is formed. Although a combination photodynamic implant with the conformable member 170 containing a cured curable liquid can be removed from the bone cavity, to simplify the removal of a combination photodynamic implant, the conformable member 170 can be expanded with a fluid that remains flowable inside the conformable member 170 so that the conformable member 170 can be easily deflated and removed, if necessary, thereby facilitating the removal of the load bearing member. Suitable examples of non-curable fluids include, but are not limited to, air, water or buffer solution or any other fluid that is non-curable. It should be noted that in an embodiment, the conformable member 170 can be formed by a cured light sensitive liquid, without a balloon.
In an embodiment, the expansion fluid may 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 conformable member 170 may be defined as enough expansion fluid to expand the conformable member 170 to a desired shape and size. The desired shape and size of the conformable member 170 may vary somewhat from patient to patient. Thus, a user using a unit dose may have excess expansion fluid left over. It is desirable to provide sufficient amount of expansion fluid to accommodate even the above-average patient. In an embodiment, a unit dose of a expansion fluid of the present disclosure is contained within a container. In an embodiment, a unit dose of a expansion fluid of the present disclosure is contained in an ampoule. In an embodiment, the conformable member 170 is sufficiently shaped and sized to fit within a space or a gap in a fractured bone. In an embodiment, the expansion fluid can be delivered under low pressure via a standard syringe attached to the port.
The conformable member 170 may be provided with a shape demanded by, for example, the anatomy of the implantation site, characteristics of the load bearing member 115 or both. Suitable shapes include, but not limited to, round, flat, cylindrical, dog bone, barbell, tapered, oval, conical, spherical, square, rectangular, toroidal and combinations thereof. The conformable member 170 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 an embodiment, the conformable member 170 is manufactured from a polyethylene terephthalate (PET). In an embodiment, the conformable member 170 is manufactured from a radiolucent material, which permit x-rays to pass through the conformable member 170. In an embodiment, the conformable member 170 is manufactured from a radiolucent polyethylene terephthalate (PET). In an embodiment, the conformable member 170 is manufactured from a conformable compliant material that is limited in dimensional change by embedded fibers. In an embodiment, at least a portion of the external surface of the conformable member 170 is substantially even and smooth.
In an embodiment, at least a portion of the external surface of the conformable member 170 includes at least one textured element such as a bump, a ridge, a rib, an indentation or any other shape. In an embodiment, at least a portion of the external surface of the conformable member 170 protrudes out to form a textured element. In an embodiment, at least a portion of the external surface of the conformable member 170 invaginates to form a textured element. In an embodiment, the textured element increases the friction and improves the grip and stability of the conformable member 170 after the conformable member 170 is inserted into the fracture location. In an embodiment, the textured element results in increased interdigitation of bone-device interface as compared to an conformable member without textured elements. In an embodiment, the textured element can be convex in shape. In an embodiment, the textured element can be concave in shape. In an embodiment, the textured element can be circumferential around the width of the conformable member 170, either completely or partially.
In general, bone graft or bone graft substitute can be used in conjunction with an conformable member 170 of the present disclosure. In an embodiment, the bone graft is an allogeneic bone graft. In an embodiment, the bone graft is an autologous bone graft. In an embodiment, the bone graft substitute is a hydroxyapatite bone substitute. In an embodiment, a bone graft or bone graft substitute is used to fill in any gaps that may exist, for example, between the external surface of the conformable member 170 and the surfaces of the bone fragments. In an embodiment, a bone graft or bone graft substitute is used to fill any gaps that may exist, for example, between the textured element of the conformable member 170 and the surfaces of the bone fragments.
In general, the conformable member 170 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 minimally invasive 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 conformable member 170 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 may be added to the external surface of the conformable member 170 to help induce the formation of new bone. Due to the lack of thermal egress of the light-sensitive liquid 165 in the conformable member 170, the effectiveness and stability of the coating is maintained.
In general, the conformable member 170 typically does not have any valves. One benefit of having no valves is that the conformable member 170 may be expanded or reduced in size as many times as necessary to assist in the fracture reduction and placement. Another benefit of the conformable member 170 having no valves is the efficacy and safety of the system 100. Since there is no communication passage of light-sensitive liquid 165 to the body there cannot be any leakage of liquid 165 because all the liquid 165 is contained within the conformable member 170. In an embodiment, a permanent seal is created between the conformable member 170 and the delivery catheter 150 that is both hardened and affixed prior to the delivery catheter 150 being removed.
In an embodiment, abrasively treating the external surface of the conformable member 170, for example, by chemical etching or air propelled abrasive media, improves the connection and adhesion between the external surface of the conformable member 170 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.
FIG. 2 in conjunction with FIG. 3A and FIG. 3B show schematic illustrations of an embodiment of a system 200 that can be used to implant the conformable member 170 and infuse the expansion fluid into the conformable member 170. In the embodiment where the expansion fluid is a light-sensitive liquid 165, the system 200 can also be used to cure the light-sensitive liquid 165 inside the conformable member 170. System 200 includes a light source 110, a light pipe 120, an attachment system 130 and a light-conducting fiber 140. The attachment system 130 communicates light energy from the light source 110 to the light-conducting fiber 140. In an embodiment, the light source 110 emits frequency that corresponds to a band in the vicinity of 390 nm to 770 nm, the visible spectrum. In an embodiment, the light source 110 emits frequency that corresponds to a band in the vicinity of 410 nm to 500 nm. In an embodiment, the light source 110 emits frequency that corresponds to a band in the vicinity of 430 nm to 450 nm. The system 200 further includes a flexible delivery catheter 150 having a proximal end that includes at least two ports and a distal end terminating in an conformable member 170. In an embodiment, the conformable member 170 is sufficiently shaped to fit within a space or a gap in a fractured bone. In an embodiment, the conformable member 170 is manufactured from a non-compliant (non-stretch/non-expansion) conformable material. In an embodiment, the conformable member 170 is manufactured from a conformable compliant material that is limited in dimensional change by embedded fibers. One or more radiopaque markers, bands or beads may be placed at various locations along the conformable member 170 and/or the flexible delivery catheter 150 so that components of the system 200 may be viewed using fluoroscopy.
In the embodiment shown in FIG. 2, the proximal end includes two ports. One of the ports can accept, for example, the light-conducting fiber 140. The other port can accept, for example, a syringe 160 housing a light-sensitive liquid 165. In an embodiment, the syringe 160 maintains a low pressure during the infusion and aspiration of the light-sensitive liquid 165. In an embodiment, the syringe 160 maintains a low pressure of about 10 atmospheres or less during the infusion and aspiration of the light-sensitive liquid 165. In an embodiment, the light-sensitive liquid 165 is a photodynamic (light-curable) monomer. In an embodiment, the photodynamic (light-curable) monomer is exposed to an appropriate frequency of light and intensity to cure the monomer inside the conformable member 170 and form a rigid structure. In an embodiment, the photodynamic (light-curable) monomer 165 is exposed to electromagnetic spectrum that is visible (frequency that corresponds to a band in the vicinity of 390 nm to 770 nm). In an embodiment, the photodynamic (light-curable) monomer 165 is radiolucent, which permit x-rays to pass through the photodynamic (light-curable) monomer 165.
As illustrated in FIG. 3A and FIG. 3B, the flexible delivery catheter 150 includes an inner void 152 for passage of the light-sensitive liquid 165, and an inner lumen 154 for passage of the light-conducting fiber 140. In the embodiment illustrated, the inner lumen 154 and the inner void 152 are concentric to one another. The light-sensitive liquid 165 has a low viscosity or low resistance to flow, to facilitate the delivery of the light-sensitive liquid 165 through the inner void 152. In an embodiment, the light-sensitive liquid 165 has a viscosity of about 1000 cP or less. In an embodiment, the light-sensitive liquid 165 has a viscosity ranging from about 650 cP to about 450 cP. The conformable member 170 may be inflated, trial fit and adjusted as many times as a user wants with the light-sensitive liquid 165, up until the light source 110 is activated, when the polymerization process is initiated. Because the light-sensitive liquid 165 has a liquid consistency and is viscous, the light-sensitive liquid 165 may be delivered using low pressure delivery and high pressure delivery is not required, but may be used.
In an embodiment, a contrast material may be added to the light-sensitive liquid 165 without significantly increasing the viscosity. Contrast materials include, but are not limited to, barium sulfate, tantalum, or any other suitable contrast materials. The light-sensitive liquid 165 can be introduced into the proximal end of the flexible delivery catheter 150 and passes within the inner void 152 of the flexible delivery catheter 150 up into an inner cavity 172 of the conformable member 170 to change a thickness of the conformable member 170 without changing a width or depth of the conformable member 170. In an embodiment, the light-sensitive liquid 165 is delivered under low pressure via the syringe 160 attached to the port. The light-sensitive liquid 165 can be aspirated and reinfused as necessary, allowing for thickness adjustments to the conformable member 170 prior to activating the light source 110 and converting the liquid monomer 165 into a hard polymer.
As illustrated in FIG. 2 in conjunction with FIG. 3B, the light-conducting fiber 140 can be introduced into the proximal end of the flexible delivery catheter 150 and passes within the inner lumen 154 of the flexible delivery catheter 150 up into the conformable member 170. The light-conducting fiber 140 is used in accordance to communicate energy in the form of light from the light source to the remote location. The light-sensitive liquid 165 remains a liquid monomer until activated by the light-conducting fiber 140 (cures on demand). Radiant energy from the light source 110 is absorbed and converted to chemical energy to polymerize the monomer. The light-sensitive liquid 165, once exposed to the correct frequency light and intensity, is converted into a hard polymer, resulting in a rigid structure or photodynamic implant. In an embodiment, the monomer 165 cures in about five seconds to about five minutes. This cure affixes the conformable member 170 in an expanded shape to form a photodynamic implant.
Light-conducting fibers use a construction of concentric layers for optical and mechanical advantages. The light-conducting fiber can be made from any material including, but not limited to, glass, silicon, silica glass, quartz, sapphire, plastic, combinations of materials, or any other material, and may have any diameter. In an embodiment, 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 0.75 mm and approximately 2.0 mm. In some embodiments, the light-conducting fiber can have a diameter of about 0.75 mm, about 1 mm, about 1.5 mm, about 2 mm, less than about 0.75 mm or greater than about 2 mm. In an embodiment, the light-conducting fiber may be 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. In an embodiment, visible light having a wavelength spectrum of between about 380 nm to about 780 nm, between about 400 nm to about 600 nm, between about 420 nm to about 500 nm, between about 430 nm to about 440 nm, 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 of the present disclosure, at least a portion of a length of an 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 an embodiment, 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 an embodiment, removing all or part of the cladding may alter the propagation of light along the light-conducting fiber. In another embodiment, removing all or part of the cladding may alter the direction and angle of incidence of light exuded from the light-conducting fiber.
In an embodiment, the cladding is removed by making a plurality of cuts in the cladding to expose the core of the light-conducting fiber. In an embodiment, the cladding is removed in a spiral fashion. In an embodiment, 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 another embodiment, 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 another embodiment, 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 an embodiment, 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 an embodiment, the pitch or spacing between the cuts is varied along the length of the modified section of the light-conducting fiber. In an embodiment, the spacing between the cuts increases from the proximal end of the modified section of the light-conducting fiber 165 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.
Once the light-sensitive liquid 165 is cured within the conformable member 170 to form a photodynamic implant, the light conducting fiber 165 is withdrawn from the system 200 and the conformable member 170 is separated from the delivery catheter 150. In an embodiment, a separation area is located at the junction between the distal end of the conformable member 170 and the delivery catheter 150 to facilitate the release of the photodynamic implant 510 from the delivery catheter 150. The separation area ensures that there are no leaks of reinforcing material from the elongated shaft of the delivery catheter and/or the conformable member 170. The separation area seals the photodynamic implant 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 a stress concentrator, such as a notch, groove, channel or similar structure that concentrates stress in the separation area. The stress concentrator is designed to ensure that the conformable member 170 is separated from the delivery catheter 150 at the separation area. When torque (twisting) is applied to the delivery catheter 150, the conformable member 170 separates from the shaft of the delivery catheter 150. The twisting creates a sufficient shear to break the residual reinforcing material and create a clean separation of the conformable member 170/shaft interface. It should of course be understood that the conformable member 170 may be separated from the delivery catheter 150 by any other means known and used in the art.
FIGS. 4-9 show various non-limiting embodiments of combination photodynamic implants of the present disclosure. It should be noted that the load bearing member and the conformable member in each embodiment described below are not limited to features specifically described in connection with the particular embodiment, but may also can include features of the load bearing members and conformable members described above and features of the load bearing members and conformable members described in connection with other embodiments.
Referring to FIG. 4A and FIG. 4B, in an embodiment, a combination photodynamic implant 400 includes a load bearing member 115 and one or more conformable members 170 associated with the bearing member 115. In an embodiment, the load bearing member 115 is a rigid elongated rod designed for implantation into a bone cavity. In an embodiment, the load bearing member 115 is a rigid intramedullary nail, made of a metallic material such as stainless steel or titanium. In an embodiment, the load bearing member 115 is made of a flexible or semi-rigid material, such as PEEK, fiber reinforced composite polymers, or another engineering thermoplastic. The one or more conformable members 170 may be disposed at the ends of the load bearing member 115, as shown in FIG. 4A, or a distance away from the ends of the load bearing member 115, as shown in FIG. 4B. Although the combination photodynamic implant 400 in FIG. 4A and FIG. 4B is illustrated as having two conformable members 170, the combination photodynamic implant 400 can include any number of conformable members 170. The conformable member 170 can be positioned and engage the load bearing member 115 to provide longitudinal placement stability of the load bearing member 115, rotational placement stability of the load bearing member 115, or both. In an embodiment, these stabilizing actions impart both positional stability of the combination photodynamic implant 400, as well as provide stability to the intended use of the bone and implant combination.
FIG. 5A and FIG. 5B illustrate embodiments of a combination photodynamic implant 500 in which a load bearing member 115 may be transformable between a flexible state and a rigid state. The load bearing member 115 can be transformed between a flexible state for delivery to or removal from a bone cavity to a rigid state for implantation within the bone cavity. In an embodiment, the load bearing member 115 comprises a plurality of nested tubes 502, 504, 506 telescopically slidable one within another, as shown in FIG. 5A. In an embodiment, the telescopic tubes 502, 504, 506 may include a locking mechanism (not shown) such that the telescopic tubes 502, 504, 506 are slidable relative to one another when unlocked and fixed in position relative to one another when locked. In an embodiment, locking the telescopic tubes 502, 504, 506 relative to one another also transforms the load bearing member 115 from a flexible state to a rigid state. The locking mechanism can be any mechanism suitable for locking telescopic tubes.
In an embodiment, as shown in FIG. 5B, the load bearing member 115 has a compressible body 515 that can be transformed from a flexible state to a rigid state by a compressive force. In an embodiment, the conformable member 170 is passed through the compressible body 515 and, when expanded, compresses the compressible body 515 to transform the compressible body 515 from a flexible state to a rigid state. In an embodiment, the compressible body 515 may include an actuator to apply and remove a compressive force on the compressible body 515, thereby transforming the compressible body between a flexible state and a rigid state. Examples of suitable compressive bodies include, but are not limited to, a tubular spring or coil, a segmented or patterned tube, a chain of ball bearings, a chain of cylinders, a bellow-like structure, and similar. Such compressible bodies are known and are disclosed, for example, in U.S. Pat. No. 7,909,825.
In reference to FIG. 5C and FIG. 5D, in an embodiment, the load bearing member 520 has a transformable body that can be transitioned from a flexible to a rigid state when the conformable member 170 engages the load bearing member 520 and provides interference in compression or tension to features of the load bearing member 520. FIG. 5C illustrates the conformable member 170 in a deflated state positioned inside the load bearing member 520. When the conformable member 170 is moved from the deflated state to an inflated state, as shown in FIG. 5D, the conformable member 170 can extend radially out of the openings 540 between struts 542 of the transformable load bearing member 520 to transform the load bearing member 520 from a flexible state to a rigid state. In an embodiment, because the conformable member 170 fills in the openings 540, the conformable member 170 prevents the translation or compression of the load bearing member 520 back to a flexible state.
In some embodiments of a combination photodynamic implant, the load bearing member is transformable between a flexible state and a rigid state by radially expanding the load bearing member 115 by the conformable member 170 placed inside the load bearing member 115. Various suitable designs for the load bearing member 115 of the combination photodynamic implant 600 are disclosed, for example, in U.S. Pat. No. 7,909,825. In an embodiment, the conformable member 170 is inserted inside the load bearing member and is expanded to transform the load bearing member 115 from a flexible state to a rigid state. In an embodiment, the design of the load bearing member 115 is such that a light-sensitive liquid can be contained inside the load bearing member 115 without a conformable member 170, such that the light-sensitive liquid can be infused directly into the load bearing member 115 to expand the load bearing member 115.
FIG. 6A and FIG. 6B illustrate embodiments of a combination photodynamic implant in which the load bearing member is transformable between a flexible state and a rigid state by radially expanding the load bearing member by the conformable member 170 placed inside the load bearing member.
As shown in FIG. 6A, in an embodiment, the load bearing member may be a patterned tube 620. The patterned tube 620 may be flexible during the delivery of the patterned tube 620 to a bone cavity. Once the patterned tube 620 is inside the bone cavity, the conformable member 170 can be inserted into the patterned tube 620 and expanded to transform the patterned tube 620 to a rigid state.
As shown in FIG. 6B, in an embodiment, the load bearing member is a helical spring 630. The helical spring 630 is flexible during the delivery of the helical spring 630 to a bone cavity. Once the helical spring 630 is inside the bone cavity, the conformable member 170 can be inserted into the helical spring 630 and expanded to transform the patterned tube 620 to a rigid state.
In an embodiment, as shown in FIG. 6A, in addition to the conformable member 170 inside the load bearing member, one or more distinct conformable members 170 can be placed over the load bearing member or patterned tube 620 placed inside the load bearing member 620 to stiffen the load bearing member 620.
In an embodiment, as shown in FIG. 6B, the conformable member 170 is longer than the load bearing member 640 such that the conformable member 170 extends outside the load bearing member 640 and achieves a conformal fit with the bone cavity into which the photodynamic implant 600 is implanted to lock the load bearing member 640 in place inside the bone cavity. In embodiment, as shown in FIG. 6B, the conformable member 170 can also be configured to extend radially out of the openings 640 in the body of the load bearing member 640 to contact the wall of the bone cavity in which the implant 600 is implanted. In an embodiment, the load bearing member can also be made of a tubular spring or coil, a chain of ball bearings, a chain of cylinders, a bellow-like structure, and similar.
In an embodiment, the load bearing member of the combination photodynamic implant 600 can have a diameter similar to the inner diameter of the bone cavity into which the implant 600 is implanted such that the load bearing member undergoes no, or only a minimal amount of, radial expansion by the conformable member.
In reference to FIG. 6C and FIG. 6D, in an embodiment, to facilitate less invasive delivery of the combination photodynamic implant 600 to a bone cavity, the load bearing member 620 can be provided with a diameter smaller than the inner diameter of the bone cavity. In an embodiment, when the conformable member 170 expands inside the load bearing member 115, the load bearing member 115 is also expanded radially to approximate the inner diameter of the bone cavity. In an embodiment, as shown in FIG. 6C and FIG. 6D, expanding the load bearing member 115 can cause the load bearing member to contract in the longitudinal direction, thereby stiffening the load bearing member 115 and locking the load bearing 115 in place within the cavity. In an embodiment, the load bearing member 115 has a design such that there is no foreshortening in the longitudinal direction when the load bearing member 115 is expanded.
FIG. 7A illustrates an embodiment of a combination photodynamic implant 700 in which a load bearing member 620 is at least partially enclosed by a conformable member 170. FIG. 7B is a cross-sectional side view of the combination photodynamic implant 700 of FIG. 7A.
In an embodiment, the load bearing member is transformable between a flexible state and a rigid state. The load bearing member may have any design as described in regard to combination photodynamic implants 500 and 600. Upon delivering the combination photodynamic implant 700 to a bone cavity, the conformable member 170 can be expanded, thereby expanding and stiffening the load bearing member 620 and, at the same time, locking the load bearing member 620 in place within the bone cavity. In an embodiment, the load bearing member may be rigid, such as described above in reference to combination photodynamic implant 400. Curing a light-sensitive liquid inside the conformable member can further stiffen the load bearing member and assist the load bearing member in stabilizing the bone.
FIG. 8A and FIG. 8B illustrate an embodiment of a combination photodynamic implant 800 in which one or more conformable members 170 may act as cams to stabilize the load bearing member 115 in a bone cavity 802 of a bone 804 into which the load bearing member 115 is implanted. FIG. 8A shows a combination photodynamic implant 800 having one or more conformable members 170 acting as cams to stabilize the load bearing member 115. FIG. 8B shows such combination photodynamic implant 800 in a bone cavity 802 of a bone 804. In an embodiment, the one or more conformable members are placed about a load bearing member 115 between the load bearing member 115 and the walls of the bone cavity 802. In an embodiment, the one or more conformable members 170 can be permanently attached to the load bearing member 115. In an embodiment, the one or more conformable members 170 are detachably attached to the load bearing member 115.
In an embodiment, use of multiple conformable members 170 facilitates both tightening to slightly increase radial tension of conformable member 170 structures on cortical wall, as well as reversibility to decrease tension to simplify the removal of the combination photodynamic implant 800. In an embodiment, the one or more conformable members 170 may be filled with a non-curable fluid, that is a fluid that will remain flowable (i.e. non-cured) inside the one or more conformable members 170, such as air or water or buffer solution, to ensure the ease of removal of the one or more conformable members 170.
In an embodiment, the conformable members 170 that at least partially enclose or encircle the load bearing member, as shown in FIG. 8B, stabilize the load bearing member, and through contact with the cancellous or cortical wall of the bone, fixate and stabilize the fractured bone. In an embodiment, this method of stabilization may not require the use of cross-locking screws used in load bearing intramedullary rods to facilitate longitudinal and rotational stability to allow the bone to heal. The placement of cross-locking screws into intramedullary rods is often time consuming, require the use of targeting jigs and/or fluoroscopy to ensure that the cross-locking screw enters into pre-defined holes in metallic implants in particular. In an embodiment, by not requiring the use of cross-locking screws, the combination implant illustrated in FIG. 8B can securely stabilize a fractured or weakened bone, while simultaneously eliminating or limiting the time and tissue dissection necessary to place cross-locking screws at exact locations in particular in metallic intramedullary nails.
Referring to FIG. 8C, FIG. 8D, and FIG. 8E, in an embodiment, the combination photodynamic implant 800 includes an internal cam structure 810. The one or more conformable members 170 are acted upon by the cam structure 810 to enable user-adjustable tension or compression to increase pressure between the load bearing member 115 containing the cam structure 810, the one or more conformable members 170 and/or the cortical bone to stabilize the load bearing member 115 in the bone cavity 802 of the bone 804. In an embodiment, use of multiple conformable members 170 facilitates both tightening via the action of the cam structure 810 contained in or a part of the load bearing member 115 to slightly increase radial tension of the multiple conformable members 170 on cortical wall, as well as reversibility to decrease tension to simplify the removal of the combination photodynamic implant 800. Once the conformable members 170 are expanded with the expansion fluid, and, in the instance when the expansion fluid comprises the curable liquid, the curable liquid is hardened, rotating the internal cam structure 810 into a locking position, as shown in FIG. 8C, pushes the conformable members into the wall of the bone cavity 802, thereby increasing radial pressure on the cortical wall, securely locking the combination photodynamic implant 800 inside the bone cavity 802. Rotating the internal cam structure 810 into a release position, as shown in FIG. 8D, releases the pressure on the conformable member 170, thereby enabling the repositioning or removal of the conformable members 170 and, consequently, the repositioning or removal of the load bearing member 115, as shown in FIG. 8E.
FIG. 8F shows another embodiment of the cam structure shown in FIG. 8C, FIG. 8D, and FIG. 8E where the conformable members 170 are moved in and away from the bone 804. In an embodiment, a process known as dynamization is used to spur healing of bones, including, but not limited to, the femur and tibia. With traditional intramedullary nails that are locked to the bone via cross-locking screws, if the bone does not begin healing quickly, the surgeon may remove one to many screws, thereby loosening the implant. Fully rigid fixation almost eliminates micro-motion at the fracture, and when this is not present the normal stress on the bone is gone which can slow or interrupt the healing process which responds positively to small motions and stress. In an embodiment, the process of dynamization can be used to loosen an implant so that the two ends of the bone move towards each other, creating compression across the fracture line, which also can help stimulate the healing response particularly in the femur and tibia. In an embodiment, the cam structure shown in FIG. 8F could also be used as a dynamization step where the implant is slightly loosened within the bone, allowing either the force of standing (or just putting pressure on the leg without full standing weight) to provide compression across the fracture line, or enough loosening such that low stress and micromotion is imparted to stimulate the bone healing response.
In another embodiment, as shown in FIG. 8G, at least one or more bone fixation devices 820 including, but not limited to, cross locking screws, can be placed across the cortical bone 804 anywhere into the cured conformable member 170 to provide addition longitudinal or rotational stability. Simple targeting may represent a significant time and fluoroscopy dose savings as exact match to pre-existing holes will not be required. In an embodiment, the surgeon can place the bone fixation device 820 such as a cross locking screw anywhere along the length of the conformable member(s) 170, thereby securing the whole combination implant 800 and bone construct to facilitate healing or reinforcement of weakened bone.
FIG. 8H shows an embodiment of a bone implant 800 where the load bearing member 115 is adjacent to at least one conformable member 170. In an embodiment, a load bearing member 114 is entrained by the conformable member(s) 170 that are adjacent to the load bearing member 115 longitudinally. In addition to having the conformable member 170 positioned radially outward from the load bearing member 115, as shown in FIG. 8C, for example, and partially enclosing the load bearing member 115 rotationally, in an embodiment, a conformable member 170 is placed at each end of the load bearing member 115 along the longitudinal axis of the load bearing member 115 holding the load bearing member 115 in place and thereby limiting the axial movement of the load bearing member 115.
FIG. 9A and FIG. 9B illustrate an embodiment of a combination photodynamic implant 900 of the present disclosure in which the load bearing member 115 is modular. In an embodiment, the load bearing member can be made up of multiple segments 902, 904 attachable to one another in an end to end fashion. Each segment has a first end 902 a, 904 a and a second end 902 b, 904 b, wherein the second end 902 b of a first segment 902 can be attached to the first end 904 a of a second segment 904 adjacent to the first segment 902. In an embodiment, the second end 902 b of the first segment 902 can be in the form of a male fitting and the first end 904 a of the second segment 904 can be in the form of a female coupling such that the first segment 902 and the second segment 904 can be joined together, as shown in FIG. 9B. Any other suitable means for connection of the first and second segments 902, 904 can also be employed. In operation, the first segment 902 and the second segment 904 can be delivered to a bone cavity separately and assembled inside the bone cavity. In an embodiment, to help ensure that the first segment 902 and the second segment 904 are aligned, the load bearing member can be assembled over an obturator. Once the modular load bearing member 115 is assembled inside the bone cavity, the conformable member 170 can be inserted into the assembled load bearing member 115 and expanded to increase the strength and rigidity of the load bearing member 115. In an embodiment, the conformable member 170 can expand outside of the load bearing member 115, as shown in FIG. 9B. In this manner, the conformable member 170 can bias the segments of the load bearing member 115 toward one another, thereby ensuring that the load bearing member 115 does not come apart. Moreover, in this manner, the conformable member may be used to add rotational and longitudinal stability to the load bearing member 115. In an embodiment, the inner void of the modular load bearing member may sealed so that a light-sensitive liquid can be infused into the inner void of the modular load bearing member 115 without a balloon.
FIGS. 10A-10F illustrate an embodiment of method steps for implanting an expandable portion of an intramedullary implant of the present disclosure within the intramedullary space of a weakened or fractured bone. A minimally invasive incision (not shown) is made through the skin of the patient's body to expose a fractured bone 1002. The incision may be made at the proximal end or the distal end of the fractured bone 1002 to expose the bone surface. Once the bone 1002 is exposed, it may be necessary to retract some muscles and tissues that may be in view of the bone 1002. As shown in FIG. 10A, an access hole 1010 is formed in the bone by drilling or any other suitable methods. The access hole 1010 may have any suitable diameter. In an embodiment, the access hole 1010 has a diameter of about 3 mm to about 10 mm. In an embodiment, the access hole 1010 has a diameter of about 3 mm.
The access hole 1010 extends through a hard compact outer layer 1020 of the bone into the relatively porous inner or cancellous tissue 1025. For bones with marrow, the medullary material should be cleared from the medullary cavity prior to insertion of the inventive device. Marrow is found mainly in the flat bones such as hip bone, breast bone, skull, ribs, vertebrae and shoulder blades, and in the cancellous material at the proximal ends of the long bones like the femur and humerus. Once the medullary cavity is reached, the medullary material including air, blood, fluids, fat, marrow, tissue and bone debris should be removed to form a void. The void is defined as a hollowed out space, wherein a first position defines the most distal edge of the void with relation to the penetration point on the bone, and a second position defines the most proximal edge of the void with relation to the penetration site on the bone. The bone may be hollowed out sufficiently to have the medullary material of the medullary cavity up to the cortical bone removed. Any suitable method for removing the medullary material may be used. Suitable methods include, but are not limited to, those described in U.S. Pat. No. 4,294,251 entitled “Method of Suction Lavage,” U.S. Pat. No. 5,554,111 entitled “Bone Cleaning and Drying system,” U.S. Pat. No. 5,707,374 entitled “Apparatus for Preparing the Medullary Cavity,” U.S. Pat. No. 6,478,751 entitled “Bone Marrow Aspiration Needle,” and U.S. Pat. No. 6,358,252 entitled “Apparatus for Extracting Bone Marrow.”
As shown in FIG. 10B, a guidewire 1028 may be introduced into a bone cavity 1003 the bone 1002 via the access hole 1010 and placed between bone fragments 1004 and 1006 of the bone 1002 to cross the location of a fracture 1005. The guidewire 1028 may be delivered into the bone cavity 1003 and positioned across the location of the break 1005 so that the guidewire 1028 spans multiple sections of bone fragments.
Next, as shown in FIG. 10B and FIG. 10C, a combination photodynamic implant of the present disclosure can be delivered over the guidewire 1028 into the bone cavity 1003. The combination photodynamic implant is placed to cross the fracture 1005 and spans the bone fragments 1004 and 1006 of the bone 1002. In an embodiment, the load bearing member 115 is delivered to the bone cavity 1003 first and then the conformable member 170 is delivered to the bone cavity and is associated with the load bearing member 115. It should be noted that although as illustrated the delivery of the load bearing member 115 precedes the delivery of the conformable member 170, the sequence of delivery will depend on the design of the combination photodynamic implant utilized in the procedure, design of the combination photodynamic implant, user's preference or combination thereof.
Once the conformable member 170 and the load bearing member 115 are in the desired position, the guidewire 1028 may be removed. The location of the conformable member 170 and the load bearing member 115 is determined using at least one radiopaque marker 1030 which may be detectable from the outside or the inside of the bone 1002. Next, the conformable member 170 is expanded by adding the expansion fluid to the conformable member 170 through the inner void of the delivery catheter 150, as shown in FIG. 10D. As the conformable member 170 expands, the conformable member 170 stiffens the load bearing member 115, lock the load bearing member 115 in place, or both, depending on the design of the combination photodynamic implant utilized in the procedure.
In the embodiment where a light-sensitive liquid is used to expand the conformable member 170, a delivery system which contains a light-sensitive liquid is attached to the port of the delivery catheter 150 in communication with the inner void of the delivery catheter 150. The light-sensitive liquid is then infused through the inner void in the delivery catheter 150 into the conformable member 170. This addition of the light-sensitive liquid within the conformable member 170 causes the conformable member 170 to expand, as shown in FIG. 10D. FIG. 2, FIG. 3A and FIG. 3B also show an example of a system for expanding the conformable member 170 with a light-sensitive liquid 165. Once orientation of the bone fragments 1004 and 1006 as well as the position of the load bearing member 115 and conformable member 170 are confirmed to be in a desired position, the light-sensitive liquid may be hardened within the conformable member 170, as shown in FIG. 10E, such as by illumination with a visible emitting light source. In an embodiment, during the curing step, a syringe housing a cooling media may be attached to the proximal end of the insertion catheter and continuously delivered to the conformable member 170. The cooling media can be collected by connecting tubing to the distal end of the inner lumen and collecting the cooling media via the second distal access hole. After the light-sensitive liquid has been hardened, the light source may be removed from the device. Alternatively, the light source may remain in the conformable member 170 to provide increased rigidity.
Referring to FIG. 10F, the expanded conformable member 170 may be released from the delivery catheter 150 by any suitable method, thereby forming a combination photodynamic implant 1030. In an embodiment, the expanded conformable member 170 achieves a conformal fit with the bone cavity 1025 to provide longitudinal and rotational stability to the combination photodynamic implant 1030. Additionally or alternatively, one or more fasteners 102 may be inserted through the bone into the photodynamic implant 1030 to further stabilize the photodynamic implant within the bone cavity 1025 of the fractured bone 1002. In an embodiment, an external bone plate 1130 may be attached to the combination photodynamic implant 1030, as shown in FIG. 10F.
In one aspect, a combination photodynamic device includes at least one load bearing member designed to reside in a cavity of a fractured or weakened bone, and at least one conformable member connected to the at least one load bearing member. The at least one load bearing member acts as an internal bone fixation and stabilization device. The at least one conformable member is configured to be expandable from a deflated state to an inflated state to anchor the at least one load bearing member inside the cavity.
In an embodiment, a combination photodynamic device of the present disclosure includes a load bearing member and one or more conformable members associated with the load bearing member, the conformable member expandable from a deflated state to an inflated state with an expansion fluid. The load bearing member is designed to reside inside of a cavity within a bone and act as internal bone fixation and stabilization device, while the conformable member is designed to anchor the load bearing member inside the intramedullary cavity to provide longitudinal and rotational stability to the load bearing member. In an embodiment, expanding the conformable member from a deflated state to an expanded state locks the load bearing member in place within a bone cavity into which its implanted as well as transforms the load bearing member from a flexible state to a rigid state.
In one aspect, a method for bone repair and stabilization includes: inserting a load bearing member into a cavity of a fractured or weakened bone; inserting one or more conformable members into the cavity; engaging the one or more conformable members with the load bearing member; and expanding the conformable member with an expansion fluid, thereby anchoring the load bearing member inside the cavity and providing longitudinal and rotational stability to the load bearing member during the healing process.
In an embodiment, a method for bone repair and stabilization that includes inserting a load bearing member into a cavity of a fractured or weakened bone, inserting one or more conformable members into the cavity, associating the one or more conformable members with the load bearing member, and expanding the conformable member with an expansion fluid, thereby anchoring the load bearing member inside the intramedullary cavity, providing longitudinal and rotational stability to the load bearing member during the healing process, transforming the load bearing member from a flexible state to a rigid state, contributing to fixating and stabilizing a fractured or a weakened bone, providing longitudinal and rotational stability to a fractured or a weakened bone during the healing process or combinations thereof.
In one aspect, a combination photodynamic device kit includes: at least one expansion fluid; a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween; a conformable member releasably engaged to the distal end of the delivery catheter and wherein the delivery catheter has an inner void for passing the at least one expansion fluid into the conformable member; and a load bearing member, wherein the load bearing member can be engaged with the conformable member.
In an embodiment, there is provided a combination photodynamic device kit that includes a unit dose of at least one expansion fluid, a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween, wherein a conformable member is releasably engaged to the distal end of the delivery catheter and wherein the delivery catheter has an inner void for passing the at least one expansion fluid into the conformable member, and a load bearing member, wherein the load bearing member can be associated with the conformable member. In an embodiment, the kit includes a plurality of conformable members of different sizes or shapes. In an embodiment, the kit includes a light source.
All patents, patent applications, and published references cited herein are hereby incorporated by reference in their entirety. It will be appreciated that several of the above-disclosed and other features and functions, or alternatives thereof, may be desirably combined into many other different systems or application. Various presently unforeseen or unanticipated alternatives, modifications, variations, or improvements therein may be subsequently made by those skilled in the art.

Claims

1. A combination photodynamic device comprising:

at least one load bearing member designed to reside in a cavity of a fractured or weakened bone, the at least one load bearing member acting as an internal bone fixation and stabilization device;

at least one conformable member connected to the at least one load bearing member, the at least one conformable member configured to be expandable from a deflated state to an inflated state to anchor the at least one load bearing member inside the cavity.

2. The device of claim 1, wherein the at least one conformable member is expandable from a deflated state to an inflated state using an expansion fluid.

3. The device of claim 1, wherein the at least one conformable member is a balloon.

4. The device of claim 1, wherein the at least one conformable member is designed to transform the at least one load bearing member from a flexible state for delivery to or removal from the cavity of the bone to a rigid state for implantation within the cavity of the bone.

5. The device of claim 1, wherein the at least one conformable member is detachably or removably attached to the at least one load bearing member.

6. The device of claim 1, wherein the at least one load bearing member has a threaded end so that the at least one load bearing member can be screwed into the bone.

7. The device of claim 1, wherein the at least one load bearing member is an elongated rod or an intramedullary nail.

8. The device of claim 1, wherein the at least one load bearing member is made of a flexible material.

9. The device of claim 1, wherein the at least one load bearing member includes a plurality of nested tubes telescopically slidable relative to one another.

10. The device of claim 1, wherein the at least one load bearing member has a compressible body that can be transformed from a flexible state to a rigid state by a compressive force.

11. The device of claim 1, wherein the at least one load bearing member is transformable between a flexible state and a rigid state by radially expanding the at least one load bearing member using the conformable member placed inside the load bearing member.

12. The device of claim 1, wherein the at least one load bearing member is as at least partially enclosed by the at least one conformable member.

13. The device of claim 1, wherein the at least one load bearing member is adjacent to the at least one conformable member.

14. The device of claim 1, wherein the at least one load bearing member is a flexible patterned tube or a flexible helical spring, and the at least one conformable member is configured to be inserted in the at least one load bearing member and expanded to transform the at least one load bearing member to a rigid state.

15. The device of claim 1, further comprising one or more holes in the at least one load bearing member and/or at least one conformable member for receiving one or more fasteners to secure the device to the bone.

16. The device of claim 1, further comprising a cam structure attached to the at least one load bearing member and configured to act upon the at least one conformable member to increase pressure between the at least one load bearing member containing the cam structure, the at least one conformable member, and/or the weakened or fractured bone to stabilize the load bearing member in the cavity of the bone.

17. The device of claim 1, wherein the at least one load bearing member includes one or more segments.

18. A combination photodynamic device kit comprising:

at least one expansion fluid;

a delivery catheter having an elongated shaft with a proximal end, a distal end, and a longitudinal axis therebetween;

a conformable member releasably engaged to the distal end of the delivery catheter and wherein the delivery catheter has an inner void for passing the at least one expansion fluid into the conformable member; and

a load bearing member, wherein the load bearing member can be engaged with the conformable member.

19. The kit of claim 18, further comprising a plurality of conformable members of different sizes or shapes.

20. A method for bone repair and stabilization comprising:

inserting a load bearing member into a cavity of a fractured or weakened bone;

inserting one or more conformable members into the cavity;

engaging the one or more conformable members with the load bearing member; and

expanding the conformable member with an expansion fluid, thereby anchoring the load bearing member inside the cavity and providing longitudinal and rotational stability to the load bearing member during the healing process.

21. The method of claim 20, wherein the load bearing member is flexible when inserted into the cavity, and becomes rigid upon expanding the conformable member with an expansion fluid.