The inventive packages and methods generally relate to the field of implants for use in the body, and the packaging, storing, and rehydration of the implants.
Many spinal fusion implants are made of human bone, and may take the form of autografts (the patient's bone), allografts (another human's bone), xenografts (non-human species' bone), synthetic implants, or combinations thereof. These implants, especially allografts, are often freeze-dried to extend the useful shelf life of the implant. For optimal performance of the implant during surgical implantation, it is highly recommended that an implant, previously freeze-dried, be hydrated prior to implantation. Such hydration may take place in a saline solution, or any number of known rehydration materials. Implants that are not rehydrated prior to implantation are prone to fracture due to the loads applied during surgical insertion and/or impaction.
While the general materials and procedures for forming, freeze-drying, rehydrating, and inserting spinal implants is generally known, there exists a need to simplify the rehydration materials and methods. Currently, freeze-dried implants are delivered to an operating room in a single-piece sterilized package, or a double-packed sterilized package, having a sterile inside, but a non-sterile outside. The implants must be removed form the packaging and thereafter placed in an open container of rehydrating fluid for rehydration prior to use. There exists a need for materials and methods for making the rehydration process more sterile, simple, and convenient.
A package for rehydrating an implant is described, comprising: a first chamber containing a rehydration fluid; a second chamber containing an implant; a seal in communication with at least a portion of the first and second chambers; wherein the first and second chamber are at least partially separated by a barrier, the barrier configured to be affected; and wherein after the barrier is affected, at least a portion of the rehydration fluid is able to engage the implant without detaching the seal.
The first chamber may have a first pressure and the second chamber may have a second pressure, and wherein before the barrier is affected, the first pressure may be greater than the second pressure.
The implant may be an allograft, autograft, xenograft, or may be at least partially comprised of a synthetic material.
The barrier may be configured to be affected by external load or pressure. The barrier may be configured to be affected by at least one protrusion. The barrier may be configured to be affected by axial strain.
The package may further comprise a third chamber. The first chamber may further contain a pouch, and wherein the rehydration fluid may be enclosed in the pouch. The barrier may be a portion of the pouch.
A method of rehydrating an implant is also described, comprising the steps of: (a) providing a package for rehydrating an implant, comprising: a first chamber containing a rehydration fluid; a second chamber containing an implant; a seal in communication with at least a portion of the first and second chambers; wherein the first and second chamber are at least partially separated by a barrier; (b) affecting the barrier, thereby permitting at least a portion of the rehydration fluid to enter the second chamber; (c) permitting the rehydration fluid to contact the implant; (d) detaching at least a portion of the package to expose the implant for retrieval by a user; and (e) removing the implant from the package.
Step (d) may involve detaching the entire seal. The implant in step (a) may be freeze-dried. The first chamber may be supplied under a higher pressure than the second chamber. The barrier may be ruptured.
While preferred features of the present invention may be disclosed in the accompanying illustrative, exemplary drawings, for the purposes of description, the invention as defined by the claims should be in no way limited to such preferred features or illustrative and exemplary drawings, wherein:
It is initially noted that while some of the packaging, implants, and methods herein are described with reference and application to the spine, it will be appreciated that features of the packaging, implants, and methods and the packaging, implants, and methods themselves may have other applications, and can be applied to other bones and/or parts of the skeleton. For instance, the implant may be a ligament to be used in a knee, elbow, wrist, or shoulder procedure. Further applications are expressly considered as well.
It is also contemplated that outer and inner layers 12, 14 may also be opposite sides of a package wall of package 10. In that sense, outer and inner layers 12, 14 may be integral with a common wall, with a thickness therebetween equal to the thickness of the wall.
Rehydration package 10 also may have a first chamber 20 and a second chamber 22, which may be at least partially separated by a dividing wall 16. The embodiment of
At least a portion of dividing wall 16 may comprise a barrier 30, which may be configured to be affected by several suitable methods and devices, discussed in more detail below. Moreover, the entire dividing wall 16 may be a rupturable barrier 30. Barrier 30 may be comprised of a material of suitable strength and/or thickness upon which a rupture of desired shape may be possible. For instance, if a relatively small rupture is desired, it may be beneficial to have a relatively strong and/or thick barrier 30. Barrier 30 should not be porous.
Barrier 30 may be made of a material compatible with the contents of package 10. More importantly, the material or materials comprising barrier 30 should not interfere with the desired content interaction of the package 10 after the barrier has been affected. For instance, if a portion of barrier 30 is dislodged and/or fractured during the rupturing process, it is preferable that the affected portions of barrier 30 do not interfere with any desired processes or contents of the package 10 thereafter.
In the embodiment shown in
Package 10 may also have a seal 18 overlying the chambers 20, 22. Seal 18 is shown in
Package 10 may also be enclosed in an outside package (not shown), which may contain labeling and other information. In use, package 10 may be removed from outside package before rehydrating an implant 26. Enclosing package 10 in an outside package may be beneficial in that the outside package may provide another barrier to keep package 10 sterile, such that the sterility of the outside package may be compromised without compromising the sterility of the package 10.
The movement pattern and tendency of fluid 24 from the first chamber 20 to the second chamber 22 may be altered by variations of pressures P1 and/or P2. For instance, it may be preferable to increase P1 beyond normal atmospheric pressure so that P1 is greater than P2. P1 may be artificially increased by introducing nitrogen or another inert gas to the first chamber 20. This may be achieved by way of a valve port (not shown) associated with first chamber 20, or other equivalent structure. It may be beneficial to have P1 greater than P2, so that when barrier 30 is affected, fluid 24 in first chamber 20 will immediately seek the lower pressure area of the second chamber 22 containing implant 26. This arrangement may therefore reduce total rehydration time. Similarly, P2 may be artificially reduced in comparison to P1 by creating a vacuum in the second chamber 22. The raising of P1 and the reducing of P2 may also be done in combination to produce a desired disparity between the pressures of the first and second chambers 20, 22.
Once implant 26 has been rehydrated to a satisfactory level, seal 18 may be at least partially removed so that implant 26 may be removed from package 10, and is ready for implantation into a body. The package 10 should thereafter be discarded, as it may no longer be operable or sterile.
Whether or not an implant 26 has been rehydrated to a satisfactorily level may be dependent upon several factors, including but not limited to, the size and shape of the implant, the intended use of the implant, the characteristics of the rehydration fluid, the size of the package itself, and other particulars. A satisfactory level may be partially rehydrated or fully rehydrated. One skilled in the art will appreciate that the various levels of rehydration that may be satisfactory depending on one or more of the factors discussed above.
Pouch 40 may be able to affected by use of a depressible button 50 formed in the outer layer 12. When depressible button 50 is depressed by a force (shown in the direction of the arrow), the inner layer 14 may place pressure on the pouch 40, causing outlet 42 to be affected, and releasing fluid 24 into the second chamber 22 to engage implant 26. Pouch 40 may be pressurized, as described above. Pouch 40 may also be made of material suitable for contact with fluid 24, and may be made of the same material as inner layer 14. Outlet 42 generally should be of a weaker structural strength and/or thinner material than that of the remainder of pouch 40, so that fluid 24 will exit the pouch adjacent to the second chamber 22. Moreover, the package 10 shown in
Barrier 30 may be affected by the urging of the protrusion in the direction of the arrow by way of the depressible button 50. Preferably, the protrusion may not be urged so far as to engage and/or damage the implant 26. As discussed above, the first chamber 20 containing fluid 24 may be pressurized. Moreover, the packages 10 shown in
Barrier 30 may be rupturable by the flexing of package 10 in the direction of the arrows. The flexing of the package 10 in this way may place a sufficient strain on the barrier 30 to affect at least a portion of the barrier 30. It may be preferable in this embodiment to place the first chamber 20 under a sufficient pressure P1 to urge a sufficient amount of fluid 24 through the channel 32 and into the second chamber 22 to engage implant 26. Moreover, it may be necessary to orient the package 10 after the barrier 30 is affected to allow fluid 24 to flow through the channel 32 into second chamber 22.
It also may be preferable for the seal 18 in this embodiment to be flexible and/or fitted with a sufficient element of slack. When package 10 is flexed, the pivoting forces may exert strain on the seal 18. It would be undesirable for the seal 18 to rip and/or be removed as a result of this strain. Therefore, it may be necessary to create seal 18 out of a sufficiently flexible material to resiliently withstand the strain, or it may be necessary to fit the seal 18 on the package in such a way that it allows the seal to utilize sufficient slack to sufficiently account for the strain. Again, the packages 10 shown in
The outer and inner layer 12, 14, and dividing wall 16 may be comprised of any suitable material, including but not limited to polypropylene (PP), polyethylene (PE), Tyvek, thermal films, poly bags, PVC, aluminum foil, foil laminates, vacuum pouch, polystyrene (PS), flexible plastic packaging materials, ABS (polyacrylonitrile/co-butadine/co-styrene), PET (polyethylene terephthalate), thermoplastic elastomers, and/or combinations thereof. As stated above, it may be preferable to have the outer and inner layers 12, 14 comprised of different materials. The seal 18 may be made of sealing tape, adhesives, or the result of heat welding.
As discussed previously, at least a portion of the barrier 30 may be configured to be affected. Materials such as polypropylene (PP), polyethylene (PE), Tyvek, thermal films, poly bags, PVC, aluminum foil, foil laminates, vacuum pouch, polystyrene (PS), flexible plastic packaging materials, ABS (polyacrylonitrile/co-butadine/co-styrene), PET (polyethylene terephthalate), thermoplastic elastomers, and/or combinations thereof, may be suitable for comprising barrier 30.
This written description sets forth the best mode of the claimed invention, and describes the claimed invention to enable a person of ordinary skill in the art to make and use it, by presenting examples of the elements recited in the claims. The patentable scope of the invention is defined by the claims themselves, and may include other examples that occur to those skilled in the art. Such other examples, which may be available either before or after the application filing date, are intended to be within the scope of the claims if they have structural elements that do not differ from the literal language of the claims, or if they include equivalent structural elements with insubstantial differences from the literal language of the claims.
While the invention has been shown and described herein with reference to particular embodiments, it is to be understood that the various additions, substitutions, or modifications of form, structure, arrangement, proportions, materials, and components and otherwise, used in the practice and which are particularly adapted to specific environments and operative requirements, may be made to the described embodiments without departing from the spirit and scope of the present invention. Accordingly, it should be understood that the embodiments disclosed herein are merely illustrative of the principles of the invention. Various other modifications may be made by those skilled in the art which will embody the principles of the invention and fall within the spirit and the scope thereof.