News Column

"Interveterbral Disc Prosthesis Insertion Assemblies" in Patent Application Approval Process

August 21, 2014



By a News Reporter-Staff News Editor at Politics & Government Week -- A patent application by the inventors JODAITIS, Alexandre (MORLANWELZ, BE); DINVILLE, Herve (St-Parres-Aux-Tertres, FR); MERCIER, Alexis (TROYES, FR), filed on April 1, 2014, was made available online on August 7, 2014, according to news reporting originating from Washington, D.C., by VerticalNews correspondents.

This patent application is assigned to LDR Medical.

The following quote was obtained by the news editors from the background information supplied by the inventors: "A healthy intervertebral disc is flexible enough to allow movement between adjacent vertebrae or between a vertebra and another adjacent spinal column element, such as the coccyx (the most inferior portion of the vertebral column, resulting from the fusion of the four coccygeal vertebrae) and the sacrum (a triangular bone that is the posterior skeletal element forming the pelvis, formed by 5 fused vertebrae). This movement accommodates bending of the spine. Disease or degeneration of the tissues of a natural intervertebral disc often leads to intense pain and reduced mobility. When degeneration or disease of the natural intervertebral disc has progressed to the point where non-operative care such as medication, injections, and/or physical therapy is ineffective, surgical intervention may be required.

"A common procedure for treatment of degenerative or diseased intervertebral discs involves removal of the natural tissues of the disc and fusion of the adjacent vertebrae. Fusion eliminates the mobility between the adjacent vertebrae, however, and can transfer stresses and movements to the intervertebral discs above and/or below the point of fusion.

"Intervertebral disc prostheses have been developed to mitigate some of the problems caused by intervertebral fusion. In particular, various designs of intervertebral disc prostheses can provide a relatively normal range of movement to the adjacent vertebra, resulting in a more normal distribution of stresses and movements along the various segments of the spine. Intervertebral disc prostheses typically are configured to restore normal disc height, and can decrease surgical morbidity and complications from postoperative immobilization instrumentation typically present in fusion procedures.

"The patents FR 2 824 261, FR 2 846 550 and FR 2 865 629, and the patent application FR 2 893 838 (corresponding to applications WO 02/089701, WO 04/041129, WO 2005/074839 and WO 2007063398 and to U.S. patent application Ser. Nos. 10/476,565, 10/533,846, 11/051,710, and 11/362,253), each of which is assigned to the assignee of the present application and each of which is incorporated herein by reference for all purposes, disclose various intervertebral disc prosthesis configurations. In many of these configurations, the prosthesis may have an upper plate supporting the upper vertebra, a lower plate supporting the lower vertebra, and a mobile core or nucleus that provides some range of articulation between the upper plate and the lower plate.

"Prior to the surgical implantation procedure, measurements often are made of the plates of the upper and lower vertebrae to confirm the viability of the procedure. Following discectomy in various representative procedures, the depth and width of the intervertebral space are measured, and a determination is made of an appropriate vertical spacing of the adjacent vertebra and the sizes of the upper and lower disc prosthesis plates and the core.

"Typically, there are several selections for the depth and width of the intervertebral prosthesis plates and for the height of the core, depending on the type of intervertebral disc prosthesis. For example, the LDR Medical Mobi-C.TM. cervical disc prosthesis currently can be configured with any of 4 plate sizes and 3 core heights, and the LDR Medical Mobidisc.TM. lumbar disc prosthesis currently can be configured with any of 18 plate sizes and 6 core heights. In addition, the surgeon may wish to accommodate or correct a lordosis or kyphosis by using one or more plates having an angular offset between the vertebral axis implied by a normal to the plate's vertebral contact surface and a mean, or neutral, normal axis implied by the plate's core contact surface. Thus, even within a single product line, there may be numerous combinations of individual disc prosthesis elements available to suit the requirements of a particular patient. In various intervertebral prosthesis product systems, the upper plates, the lower plates, and the cores are provided to the sterile field of the surgical suite individually. Once the proper configuration of the upper plate, the lower plate, and the core has been determined, typically the surgical staff must acquire the proper upper plate, lower plate, and core from inventory.

"The components of the prosthesis typically are then assembled for mounting with or loading into a prosthesis insertion tool, or assembled directly with the insertion tool, hi some systems, an assembly stand or jig is used for assembling the prosthesis components and loading the assembled prosthesis into an insertion tool. The selection and assembly process can be time consuming and awkward, potentially resulting in delays during the surgical proceeding. Handling of the components during assembly process can compromise the sterility of the prosthesis, and the use of additional handling equipment, such as an assembly stand or jig, can require further sterilization procedures, increase the complexity of the procedure, and clutter the surgical suite.

"In some systems, an assortment of insertion tools are each configured for use with a single size or a limited range of sizes of the various prosthesis component combinations. Generally, the required size and configuration of the various prosthesis components will not be known until the surgical procedure has commenced. Thus, the surgeon will have to select the proper insertion tool during the procedure, following the determination of the proper sizes and configurations of the various prostheses components. The surgical staff therefore must disinfect and sterilize several insertion tools to have a full selection of the insertion tools at hand during the procedure. During the procedure, selection of the appropriate tool and confirmation of the selection will add to the duration and complexity of the surgical procedure. In various designs of insertion tools, however, the operative components of the insertion tool body are the same regardless of the prosthesis configuration, and only the tool's insertion adapter (for example, a head, holder, or other carrier of the assembled prosthesis) differs among the various insertion tools. Often, the differences among the various insertion adapters are dictated solely by the differences in sizes and configurations of the prosthesis components."

In addition to the background information obtained for this patent application, VerticalNews journalists also obtained the inventors' summary information for this patent application: "In this context, one purpose of the present invention is to overcome the drawbacks of the prior art by proposing an intervertebral disc prosthesis delivery and insertion system which is easy to use and which can be provided in a stock which can be directly used during surgical procedures.

"This purpose of the invention is reached by an intervertebral disc prosthesis delivery and insertion system comprising: (a) a demountable insertion tool body; and (b) plural intervertebral disc prosthesis insertion assemblies, each sterilized and packaged in sterile packaging to form a sterile pack and each comprising: (i) an insertion adapter having a coupler for the demountable insertion tool body and (ii) an intervertebral disc prosthesis releasably mounted to the insertion adapter.

"According to another particular feature, the intervertebral disc prosthesis has a size and configuration specification.

"According to another particular feature, the system further comprises an inventory storage space having storage locations for selected ones of the size and configuration specifications.

"According to another particular feature, each sterile pack bears identifying information observable when the respective sterile pack is stored in the inventory storage space.

"According to another particular feature, each storage location corresponds to one of the selected ones of the size and configuration specifications.

"According to another particular feature, each of the intervertebral disc prostheses comprises: a first plate having a size and configuration selected from a set of first size and configuration specifications, a second plate having a size and configuration selected from a set of second size and configuration specifications, and a core having a size and configuration selected from a set of third size and configuration specifications.

"According to another particular feature, the set of first size and configuration specifications is identical to the set of second size and configuration specifications.

"According to another particular feature, one or more of the set of first size and configuration specifications, the set of second size and configuration specifications, and the set of third size and configuration specifications contains only one element.

"According to another particular feature, the system further comprises an inventory storage space having storage locations for selected combinations of first size and configuration specifications, second size and configuration specifications, and third size and configuration specifications.

"According to another particular feature, each primary sterile pack bears identifying information observable when the respective primary sterile pack is stored in the inventory storage space.

"According to another particular feature, each storage location corresponds to one of the selected combinations of first size and configuration specifications, second size and configuration specifications, and third size and configuration specifications.

"According to another particular feature, each storage location bears information observable when the location is empty, said information identifying the one of the selected combinations of first size and configuration specifications, second size and configuration specifications, and third size and configuration specifications to which such location corresponds.

"Another purpose of the present invention is to overcome the drawbacks of the prior art by proposing Intervertebral Disc Prosthesis Insertion Assemblies which are easy to use and which can be provided in a stock which can be directly used during surgical procedures.

"This purpose is reached by an intervertebral disc prosthesis insertion assembly comprising an insertion adapter having a coupler for a demountable insertion tool body and an intervertebral disc prosthesis releasably retained by the insertion adapter.

"According to another particular feature, the insertion adapter and the intervertebral disc prosthesis are disposed in sterile packaging to form a sterile pack.

"According to another particular feature, the insertion adapter has a surface complementary to and substantially fitting the intervertebral disc prosthesis.

"According to another particular feature, the insertion adapter has at least one retainer that engages a recess and/or a post of the intervertebral disc prosthesis.

"According to another particular feature, the retainer is a latch, and the recess is disposed on an edge of a plate of the intervertebral disc prosthesis.

"According to another particular feature, the retainer is a dog, and the recess is disposed along a core of the intervertebral disc prosthesis.

"According to another particular feature, the dog has a channel substantially matching the edge of a post of a plate of the intervertebral disc prosthesis.

"Another purpose of the present invention is to overcome the drawbacks of the prior art by proposing packaged Intervertebral Disc Prosthesis Insertion Assemblies which are easy to use and which can be provided in a stock which can be directly used during surgical procedures.

"This purpose is reached by a packaged intervertebral disc prosthesis insertion assembly comprising a sterile pack in which are disposed a sterile insertion adapter having a coupler for a detachable insertion tool body and components of a sterile intervertebral disc prosthesis.

"According to another particular feature, the components of the intervertebral disc prosthesis are assembled and retained by the insertion adapter.

"Another purpose of the present invention is to overcome the drawbacks of the prior art by proposing Intervertebral Disc Prosthesis Insertion Systems which are easy to use and which can be provided in a stock which can be directly used during surgical procedures.

"This purpose is reached by an intervertebral disc prosthesis insertion system comprising: an insertion adapter having a coupler for a detachable insertion tool body; a detachable insertion tool body; and an intervertebral disc prosthesis releasably mounted to the insertion adapter.

"According to another particular feature, the insertion adapter and the intervertebral disc prosthesis are disposed in sterile packaging to form a sterile pack.

"According to another particular feature, the insertion tool body comprises an insertion actuator.

"According to another particular feature, the insertion tool body comprises an insertion stop.

"According to another particular feature, the insertion stop lock is adjustable.

"According to another particular feature, the insertion tool body comprises an insertion stop lock.

"Another purpose of the present invention is to overcome the drawbacks of the prior art by proposing methods for Intervertebral Disc Prosthesis Insertion which are easy to use and which can be provided in a stock which can be directly used during surgical procedures.

"This purpose is reached a method of inserting an intervertebral disc prosthesis between adjacent elements of a spinal column, the method comprising the steps of: providing an insertion adapter and an intervertebral disc prosthesis; mounting the intervertebral disc prosthesis to the insertion adapter to form an insertion assembly; providing an insertion tool body; mounting the insertion assembly to the insertion tool body; inserting the intervertebral disc prosthesis between adjacent elements of a spinal column; and demounting the intervertebral disc prosthesis from the insertion assembly.

"According to another particular feature, the method further comprises the step of demounting the insertion adapter from the insertion tool body and discarding the insertion adapter.

"This purpose is also reached by a method of inserting an intervertebral disc prosthesis between adjacent elements of a spinal column, the method comprising the steps of: providing an insertion adapter and components of an intervertebral disc prosthesis; assembling the components of the intervertebral disc prosthesis and the insertion adapter to form an insertion assembly; providing an insertion tool body; assembling the insertion assembly and the insertion tool body; placing the intervertebral disc prosthesis between adjacent elements of a spinal column; and removing the intervertebral disc prosthesis from the insertion assembly.

"According to another particular feature, the step of providing an insertion adapter and components of an intervertebral disc prosthesis comprises the steps of: packaging the components of the intervertebral disc prosthesis and the insertion adapter in sterile packaging to form a sterile pack; and then transporting the sterile pack to a sterile field.

"According to another particular feature, the method further comprises the steps of: packaging the insertion assembly in sterile packaging to form a sterile pack; and then transporting the sterile pack to a sterile field.

"This purpose is also reached by a method of aseptically delivering an intervertebral disc prosthesis insertion assembly to a sterile field, the method comprising the steps of: providing sterile components of an intervertebral disc prosthesis and a sterile insertion adapter having a coupler for a detachable insertion tool body; packaging the components of the intervertebral disc prosthesis and the insertion adapter into sterile packaging to form a primary sterile pack; transporting the sterile pack containing the intervertebral disc prosthesis and the insertion adapter into a sterile field; and removing the intervertebral disc prosthesis and the insertion adapter from the sterile pack within the sterile field.

"According to another particular feature, the method further comprises, prior to the step of packaging, the step of assembling the components of the intervertebral disc prosthesis and the insertion adapter.

"According to another particular feature, the method further comprises the step of packaging the primary sterile pack into a secondary sterile pack.

"Another purpose of the present invention is to overcome the drawbacks of the prior art by proposing packaged Intervertebral Disc Prosthesis Insertion Assemblies which are easy to use and which can be provided in a stock which can be directly used during surgical procedures.

"This purpose is reached by a packaged intervertebral disc prosthesis insertion assembly comprising a sterile pack in which are disposed a sterile insertion tool and sterile components of an intervertebral disc prosthesis.

"According to another particular feature, the components of the intervertebral disc prosthesis are assembled with the sterile insertion tool.

"Another purpose of the present invention is to overcome the drawbacks of the prior art by proposing Intervertebral Disc Prosthesis Insertion Systems which are easy to use and which can be provided in a stock which can be directly used during surgical procedures.

"This purpose is reached by an intervertebral disc prosthesis delivery and insertion system comprising plural packaged intervertebral disc prosthesis insertion assemblies, each of the packaged intervertebral disc prosthesis insertion assemblies comprising a sterile insertion tool and sterile components of an intervertebral disc prosthesis packaged in sterile packaging to form a primary sterile pack.

"According to another particular feature, each of the intervertebral disc prostheses has a size and configuration specification.

"According to another particular feature, the system further comprises an inventory storage space having storage locations for selected ones of the size and configuration specifications.

"According to another particular feature, each primary sterile pack bears identifying information observable when the respective primary sterile pack is stored in the inventory storage space.

"According to another particular feature, each storage location corresponds to one of the selected ones of the size and configuration specifications.

"In various embodiments, an intervertebral disc prosthesis is provided. The prosthesis may be provided with an insertion adapter, such as a head, holder, or other carrier of the prosthesis. The insertion adapter may be configured to retain the prosthesis and to engage an insertion tool body. In various embodiments, the prosthesis and the insertion holder are provided in a sterile pack, with the prosthesis components and the insertion holder sterilized and packaged in one or more types or layers of sterile packaging. In various embodiments, the prosthesis and an insertion tool are provided in a sterile pack, with the prosthesis components and the insertion holder sterilized and packaged in one or more types or layers of sterile packaging. Intervertebral disc prosthesis insertion assemblies, intervertebral disc prosthesis insertion systems, intervertebral disc prosthesis delivery and insertion systems, methods of inserting an intervertebral disc prosthesis between adjacent elements of a spinal column, methods of inserting an intervertebral disc prosthesis between adjacent elements of a spinal column, and methods of aseptically delivering an intervertebral disc prosthesis insertion assembly to a sterile field are also disclosed.

BRIEF DESCRIPTION OF THE SEVERAL VIEWS OF THE DRAWINGS

"Other features and advantages of various embodiments and various aspects of the present invention will appear more clearly to those of skill in the art on reading the description that follows, with reference to the appended drawings in which:

"FIG. 1 depicts an embodiment of a sterile pack comprising a prosthesis insertion assembly.

"FIG. 2 depicts an embodiment of a prosthesis insertion assembly.

"FIG. 3 depicts details of an embodiment of a prosthesis insertion assembly.

"FIG. 4 depicts an embodiment of an insertion tool body.

"FIGS. 5A and 5b depict components of an embodiment of an insertion tool body and a prosthesis insertion assembly.

"FIGS. 6A, 6B, and 6C depict various views of an embodiment of an insertion tool body.

"FIG. 7 depicts an embodiment of a prosthesis insertion assembly and a support of an insertion tool body.

"FIG. 8 depicts components and a portion of an embodiment of an insertion tool body.

"FIG. 9 depicts an embodiment of a prosthesis insertion assembly and a support of an insertion tool body.

"FIG. 10 depicts an embodiment of a prosthesis insertion assembly and a support of an insertion tool body.

"FIG. 11 depicts an embodiment of a prosthesis insertion assembly and a support of an insertion tool body.

"FIG. 12 depicts an embodiment of a removal tool.

"FIG. 13 depicts an embodiment of a prosthesis insertion assembly and a removal tool.

"FIG. 14 depicts an embodiment of an intervertebral disc prosthesis, an insertion adapter, and a removal tool.

"FIG. 15 depicts an embodiment of inventory storage space and a storage location.

"FIG. 16 depicts an embodiment of a storage location and configuration information.

"FIG. 17 depicts an embodiment of a sterile pack comprising a prosthesis insertion assembly.

"FIGS. 18A, 18B and 18C depict, respectively, an elevation view, a cross section view along cut plane (18B-18B) of FIG. 18A and a cross section view along cut plane (18C-18C) of FIG. 18B, of an embodiment of a prosthesis insertion assembly.

"FIGS. 19A and 19B depict perspective views of an embodiment of a prosthesis insertion assembly, respectively assembled and disassembled.

"FIGS. 20A, 20B and 20C depict, respectively, an elevation view, a cross section view along cut plane (20B-20B) of FIG. 20A and a cross section view along cut plane (20C-20C) of FIG. 20B, of an embodiment of a prosthesis insertion assembly.

"FIGS. 21A and 21B depict perspective views of, respectively, an embodiment of a disassembled prosthesis insertion assembly and an embodiment of an insertion adapter.

"FIGS. 22A, 22B and 22C depict, respectively, an elevation view of a first plate of an intervertebral disc prosthesis, a side view of a second plate of an intervertebral disc prosthesis and an elevation view of the second plate of an intervertebral disc prosthesis, according to various embodiments.

"FIGS. 23A, 23B and 23C depict, respectively, an elevation view, a cross section view along cut plane (23B-23B) of FIG. 23A and a cross section view along cut plane (23C-23C) of FIG. 23B, of an embodiment of a prosthesis insertion assembly.

"FIGS. 24A and 24B depict perspective views of an embodiment of a prosthesis insertion assembly, respectively assembled and disassembled.

"FIGS. 25A and 25B depict perspective views of an embodiment of a prosthesis insertion assembly, respectively assembled and disassembled.

"FIGS. 26A and 26B depict, respectively, a side view of a detail of the part of the prosthesis insertion assembly indicated by the reference 26A on FIG. 25A and a cross section view along cut plane (26B-26B) of the prosthesis insertion assembly of FIG. 26A, FIGS. 26C and 26D depicting, respectively, a side view of a detail of the part of the prosthesis insertion assembly indicated by reference 26C of FIG. 25A and a cross section view along cut plane (26D-26D) of the prosthesis insertion assembly of FIG. 26B."

URL and more information on this patent application, see: JODAITIS, Alexandre; DINVILLE, Herve; MERCIER, Alexis. Interveterbral Disc Prosthesis Insertion Assemblies. Filed April 1, 2014 and posted August 7, 2014. Patent URL: http://appft.uspto.gov/netacgi/nph-Parser?Sect1=PTO2&Sect2=HITOFF&u=%2Fnetahtml%2FPTO%2Fsearch-adv.html&r=1505&p=31&f=G&l=50&d=PG01&S1=20140731.PD.&OS=PD/20140731&RS=PD/20140731

Keywords for this news article include: LDR Medical, Legal Issues.

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