Reusable surgical implement

A reusable surgical implement is provided that is formed of a core positioned within an enclosure. The core is formed of a suitable flexible material to enable the implement, which can be any suitable device such as a reusable surgical trial implant, rod template or flex driver, among others, to be bent to conform to the desired shape for an actual implant to be placed in the location of the implement. The material forming the enclosure is also flexible to accommodate the flexing of the core, and is biologically inert to enable the implement to be sterilized after use for use in subsequent surgical procedures.

FIELD OF THE DISCLOSURE

The present invention relates generally to implements utilized in surgical procedures and more specifically to reusable implements utilized in surgical procedures.

BACKGROUND OF THE DISCLOSURE

There are many types of implements that are used in surgical procedures. The implements, such as implants, provide a physician with the ability to stabilize portions of the body that are being repaired in a surgical or medical procedure.

Oftentimes, the physician needs to determine the proper location and orientation for the implant prior to actually positioning and securing the implant within the body. To do so, a trial or template implant is utilized. This trial or template implant can be formed of aluminum or titanium with an anodized exterior coating (e.g., Ti06AL-4V), and is formed with a configuration similar to the form of the actual implant to be secured within the body. In use, the trial or template implant is placed within the body and manipulated by the physician to determine the proper location for the actual implant. Once determined, the location can be marked and the actual implant affixed within the body using known procedures.

However, with these prior art trial or template implants, the nature of the aluminum or anodized titanium used to form them requires that the trial or template implant be used only once and then discarded. The reason for this is that the anodized coating, which is necessary for trial or template implants formed of aluminum or titanium, can become brittle or otherwise damaged upon sterilization after an initial use. Thus, the coating can flake off during subsequent uses and consequently endanger the patient.

In addition, other implements that are designed for use in various surgical procedures are formed of rigid materials. These constructions make it difficult for medical practitioners to use devices of this type in confined spaces, and can result in the individual having to use the implement at an awkward angle. Also, in other implements of this type formed with flexible structures, the implements have exposed springs or coils which could trap debris, making the element hard to clean for subsequent uses.

To provide added functionality to these implements, some flexible implements have tubing sleeves which cover the flexible coils or springs. However, these tubes do not closely conform to the shape of the coils and/or springs, providing a space between the flexible element and the tube within which debris can be trapped.

Thus, it is desirable to develop implements for surgical procedures, such as trial or template implants, that is formed of a material that is flexible in nature and that can be sterilized and reused in multiple procedures.

SUMMARY OF THE DISCLOSURE

Briefly described, one aspect of the present disclosure provides a reusable surgical implement, such as a trial or template implant, a rod template or flex driver, among others, formed of a substantially rigid, but flexible core material that is enclosed within an inert and flexible material that is capable of being sterilized after use to enable the implement to be reused. In the case of a trial implant, the inert material is molded over the core material to conform to the shape of the actual implant to provide the appropriate representation of the actual implant to be placed within the body of the patient. Once used, the trial implant can be removed and placed with the actual implant, with the trial implant being subsequently sterilized, such as in an autoclave, for additional uses.

According to another aspect of the present disclosure, the inert material is flexible to accommodate the flexibility of the core material while maintaining the core enclosed within the inert material. Thus, the implement can be bent in order to accurately represent the proper location and configuration or use of the actual implement within the body. In addition, the material allows for implements having other uses, such as flex drivers, to be shaped and/or oriented as necessary with the inert material maintaining conformance with the flexible core material for a physician to accurately locate the implement and drive a fastener used in the procedure when presented with hard to reach areas or angles during the procedure. After use, the inert material enables the flex driver to be cleaned and/or sterilized for further uses without damaging the core material, components and mechanism(s).

According to still another aspect of the present disclosure, the inert material molded around the core material can be formed with structures or components that facilitate the engagement of the inert material with a second inert material formed around the core and the first inert material. The engagement of the first inert material with the second inert material provides an enclosure around the core material that effectively prevents dirt, dust or other debris from contacting the core material, thereby enabling repeated sterilization and usage of the core material and inert materials as a template, rod template, flex driver or other surgical device.

Numerous other aspects, features, and advantages of the present invention will be made apparent from the following detailed description together with the drawing figures.

DETAILED DESCRIPTION OF THE DRAWINGS

Referring now in detail to the drawing figures, wherein like reference numerals represent like parts throughout the several views, one exemplary embodiment of a reusable surgical implement, formed as a trial or template implant constructed according to the present disclosure is illustrated generally at10inFIG. 1. As best shown inFIGS. 1-8, the implant10is formed of a central core12and an enclosure14disposed around the core12formed of an upper portion16and a lower portion18. In the illustrated embodiment, the implant10is formed with a pre-curved shape, though other configurations for the implant10as also contemplated as being within the scope of the disclosure of the present invention.

Referring now toFIGS. 2, 4 and 8, though any suitable shape for the core12can be utilized, in the illustrated embodiment the core12is formed with a generally rectangular configuration with a first end20and a second end22joined by opposed sides24. In the illustrated embodiment the core12is also formed to be generally rectangular in cross-section with a pair of generally flat opposed surfaces26joining the ends20,22and the sides24, though any suitable cross-sectional shape can be utilized to impart the desired amount of flexibility to the core12. The core12is shaped in any suitable machine and/or process to provide the desired shape for the core12, which may include apertures or other features therein, as desired.

The material forming the core12is selected to be a generally rigid, but flexible material that can be altered in shape by applying a physical force to the core12. Once the force is removed, the core12remains in the shape to which it was altered by the applied force. In one embodiment of the core12, the core12is formed of a shape memory material, such as a shape memory metal alloy, including the materials marketed under the trade name Nitinol® by Nitinol Devices & Components, Inc. of Fremont, Calif.

The enclosure14is disposed around the core12and each portion16and18of the enclosure14is formed of a biologically inert and flexible material that can conform to the shape of the core12in any configuration for the core12. In one embodiment, the material forming the portions16and18of the enclosure14is a silicone, such as a silicone rubber, including a high consistency rubber (HCR) or liquid silicone rubber (LSR).

The portions16and18of the enclosure14are formed with features26that are identical or at least similar to those of the actual implant (not shown) to be secured within the body of the patient, to provide an accurate representation of the proper location of the actual implant in the body. The features26can include apertures28and notches30, among others. The apertures28can extend completely through the respective portions16and18without intersecting the core12, thereby preserving the integrity of the enclosure14around the core12. Further, the shape of the portions16and18forming the enclosure14can be shaped as desired to approximate the shape of the actual implant. Also, the shape of the portions16and18can be selected independently of the shape of the core12, or to conform to the shape of the core12, as desired.

In one embodiment, the trial implant10is formed by initially forming the core12of the desired material in any suitable manner, such as by extruding or molding the material into the desired shape for the core12. The core12is then placed within a suitable mold to enable the material selected form either the upper portion16or the lower portion18to be introduced into the mold containing the core12and form a portion of the enclosure14on or over the core12that contains the desired features26. Any suitable molding process can be utilized to form the upper portion16or lower portion18around the core12.

Subsequently, the core12and the portion16or18molded onto or over the core12are removed or transferred from the first mold and placed within a separate or second mold used to form the other of the upper portion16or the lower portion18on or over the core12in connection with the first portion16or18and with the desired features26. The material selected to form the other portion16or18can be selected to be the same or different than the material used to form the first portion16or18, to provide the desired attributes to the enclosure14and the implant10, so long as the materials forming the upper portion16and lower portion18are capable of mating, co-mingling or otherwise joining to one another in the molding process to form the enclosure14around the core12. Additionally, suitable materials can be applied to one or both of the portions16and/or18to properly affix the portions16and18to one another, either during molding of the portions16and18to one another, or when affixing pre-molded portions16and18to one another around the core12.

In alternative embodiments, the portions16and18can be formed subsequently or simultaneously within a single mold in any suitable molding process.

In use, the implant10in a sterile condition is placed within the body of a patient and bent, such as by hand, to conform the implant10to the shape desired for the actual implant within the body. In this position and shape, the location for suitable securing members, such as screws, are marked using the positions of the various features26formed in the implant10. The implant10can then be removed and replaced by the actual implant which is affixed within the body of the patient using the marked locations for the securing members.

Once removed from the body, the implant10can be cleaned and sterilized for additional uses. When sterilized, the heat used to sterilize the implant10can also activate the material forming the core12to return the implant10to its initial pre-bent configuration or shape, thus making the implant10ready for use once the sterilization process has been completed.

As best shown inFIGS. 9-17, a second exemplary embodiment of the implement is formed as a rod template100having a central core12′ and an enclosure14′ disposed around the core12′ formed of a first component or portion(s)16′ and a second component or portion(s)18′. In the illustrated embodiment, the rod template100is formed similarly to the implant10, and can be generally straight, though other configurations for the rod template100are also contemplated as being within the scope of the disclosure of the present invention.

Though any suitable shape for the core12′ can be utilized, in the illustrated embodiment the core12′ is formed with a generally flat rectangular or cylindrical cross-sectional shape with a first end20′ and a second end22′ joined by opposed sides24′, though any suitable cross-sectional shape can be utilized to impart the desired amount of flexibility to the core12′. The core12′ is shaped in any suitable machine and/or process to provide the desired shape for the core12′, which may include apertures or other features therein, as desired.

The material forming the core12′ is selected to be a generally rigid, but flexible material that can be altered in shape by applying a physical force to the core12′. Once the force is removed, the core12′ remains in the shape to which it was altered by the applied force. In one embodiment of the core12′, the core12′ is formed of a shape memory material, such as a shape memory metal alloy, including the materials marketed under the trade name Nitinol® by Nitinol Devices & Components, Inc. of Fremont, Calif.

The enclosure14′ is disposed around the core12′ and each portion16′ and18′ of the enclosure14′ is formed of a biologically inert and flexible material that can conform to the shape of the core12′ in any configuration for the core12′. In one embodiment, the material forming the portions16′ and18′ of the enclosure14′ is a silicone, such as a silicone rubber, including a high consistency rubber (HCR) or a liquid silicone rubber (LSR).

The portions16′ and18′ of the enclosure14′ are formed with any features (not shown) desired to enhance the utility of the implement100when utilized within the body of the patient. The features can include apertures (not shown) and notches (not shown), among others. The apertures can extend completely through the respective portions16′ and18′ without intersecting the core12′, thereby preserving the integrity of the enclosure14′ around the core12′. Further, the shape of the portions16′ and18′ forming the enclosure14′ can be shaped as desired. Also, the shape of the portions16′ and18′ can be selected independently of the shape of the core12′, or to conform to the shape of the core12′, as desired.

In the illustrated embodiment, the implement100is formed by initially forming the core12′ of the desired material in any suitable manner, such as by extruding or molding the material into the desired shape for the core12′, as shown inFIGS. 9-11. The core12′ is then placed within a suitable mold to enable the material selected to form the first portion16′ to be introduced into the mold containing the core12′ and form a portion of the enclosure14′ on or over the core12′ that contains the desired features. Any suitable molding process can be utilized to form the first portion16′ around the core12′, such as those shown in commonly owned U.S. Pat. No. 8,641,955 and its related applications, each of which are expressly incorporated by reference herein in their entirety. In the illustrated embodiment best shown inFIGS. 12-14, the first portion16′ constitutes a number of spaced sections102disposed along the length of the core12′.

Subsequently, the core12′ and the first portion16′ molded onto or over the core12′ are removed or transferred from the first mold and placed within a separate or second mold used to form the other of the second portion18′ on or over the core12′ in connection with the first portion16′ and with the desired features. The material selected to form the second portion18′ can be selected to be the same or different in one or more respects or attributes than the material used to form the first portion16′, in order to provide the desired attributes to the enclosure14′ and the implement100, so long as the materials forming the first portion16′ and second portion18′ are capable of mating, co-mingling or otherwise joining to one another in the molding process used to form the enclosure14′ around the core12′, which can be the same or different that the process used to form the first section16′. Additionally, suitable materials can be applied to one or both of the portions16′ and/or18′ to properly affix the portions16′ and18′ to one another, either during molding of the portions16′ and18′ to one another, or when affixing pre-molded portions16′ and18′ to one another around the core12′.

In alternative embodiments, the portions16′ and18′ can be formed subsequently or simultaneously within a single mold in any suitable molding process. In the illustrated embodiment, the second portion18′ includes a number of spaced sections104disposed along the length of the core12′ alternating in a sequential manner between and joining the sections102to form the enclosure14′. In this embodiment, as shown inFIGS. 15-17, the sections102and104form a seamless enclosure14′ around the core12′ complete with end caps106disposed over each end20,22of the core12, which can be molded with either of the sections102or104, or separately therefrom. The seamless enclosure14′ moves and/or flexes with the core12′ to retain the core12′ encased within the enclosure14′, such that the sterilization of the implement100does not contact the core12′.

A third embodiment of the implement200shown inFIGS. 18-23illustrates the implement200as a flex driver. The implement200includes a flexible core212, such as a spring or coil, with a pair of opposed ends220and222that, for example, is used to drive a fastener in a surgical procedure and may optionally include a mechanism suitable to assist in the driving of the fastener, such as a ratcheting or torque-limiting mechanism, among others. The ends220and222define a central section224therebetween, as best shown inFIGS. 18-21. In the embodiment shown inFIGS. 20 and 21, the first portion216, which can be formed similarly to the first portion16′ in the prior embodiment, is molded onto the core212in a first mold in a first molding step over at least approximately one half of the central section224in a suitable process, such as those cited as examples for the molding of the first portion16′ in the prior embodiment. In this process, however, the ends220and222can function as stops for the flow of the material forming the first portion216at each end220and222.

Subsequently, the core212can be removed from the first mold for positioning in a second mold, or simply rotated within the first mold to expose the uncovered portion226of the central section224within the second mold. One properly positioned, the second portion218can be formed over the uncovered section226to form the enclosure214over the central section224with the first portion216and without end caps, leaving the ends220,222exposed. In this configuration, the core212can be flexed as desired to properly orient the ends220,222to utilize the implement200, but the enclosure214remains in close conformance with the core212to prevent debris from becoming positioned between the enclosure214and the core212, and to limit the exposure of the core212to the sterilization environment when being sterilized for subsequent uses.

In alternative embodiments for either embodiment of the implement100,200, the process for molding the first portion16′,216and/or second portion18′,218can be performed in any number of separate molding steps in order to form the enclosure14′,214on the core12′,212with the desired appearance, attributes or other characteristics with any desired number and/or types of different materials forming the portions16′,216and/or18′,218.

Additional molding processes are also available for forming the enclosure14,14′ or214around the core12,12′ or212. Examples of some of these types of molding processes are disclosed in U.S. patent application Ser. No. 14/168,600, which is expressly incorporated herein by reference.

Looking now atFIGS. 24-29, in an alternative exemplary embodiment, the implement300includes a core312, which is illustrated as an elongate rod having a circular cross-section but can have any desired cross-sectional shape, has a first portion316of a flexible and inert material molded or otherwise formed around the core312in a first molding or forming step. As best shown inFIGS. 24-26, after the first molding step, the first portion316formed in the step includes a pair of outer sections318spaced inwardly from opposed ends of the core312that are joined by an inner section320. The inner section320is integrally joined to one end of each outer section318in order to form a continuous molded piece around the core312, which can optionally encircle the core312or leave certain portions of the core312uncovered. For example, in the illustrated exemplary embodiment ofFIG. 24-30, the outer sections318do not extend completely around the core312and have a semi-circular cross-section. Further, the inner section320also does not extend completely around the core312and has a semi-circular cross-section oriented 180° from the outer sections318to facilitate the joining of the inner section320to the outer sections318. The inner section320also has a thickness or radius that is less than that of the outer sections318, such that the inner section318covers the portion of the core312where the inner section is located, but does not extend outwardly from the core312the same distance as the outer sections318.

InFIGS. 27-29, in another exemplary embodiment of the implement300after a second molding or forming step a second portion322formed of a flexible and inert material is molded or formed around and over the first portion316. The second portion322forms an enclosure324around the core312in conjunction with the first portion316. The second portion322is formed to be complementary to the outer sections318of the first portion316such that the enclosure324has an exterior surface326formed of the outer surfaces of the outer sections318of the first portion316and the second portion322. In the illustrated exemplary embodiment ofFIGS. 27-29, the second portion322completely covers the inner section320of the first portion316and forms a cylindrical enclosure324around the exposed ends321of the core312and inner section320, with a complementary radius to the outer sections318, such that the outer sections318form exposed panels327on the enclosure324within the second portion322. When formed, the material forming the second portion322bonds and/or engages the first portion316in a manner to form a seamless enclosure324around the core312.

Referring now toFIGS. 30-35, in another exemplary embodiment of the implement300the first portion316is formed around the core312with a number of inner sections320joining adjacent outer sections318, with an outer section(s)318that encloses a portion of an end321of the core312, as best shown inFIGS. 30-32. The outer section(s)318formed over the end(s)321includes a cap328that extends past the end321and terminates in an end surface330that can be flat. When the second portion322is formed or molded around the core312and the first portion316to form the enclosure324, the second portion322abuts the cap328formed by the outer section318and terminates in a flat surface332that is coplanar with the flat surface330on the cap328.

Looking now atFIGS. 36-41, in another exemplary illustrated embodiment of the implement300, the first portion316is formed around the core312with a number of inner sections320joining adjacent outer sections318, and with an outer section(s)318that encloses an end321of the core312, as best shown inFIGS. 36-38. The second portion322is formed around the core312and the first portion316as in previous embodiments, but the second portion322abuts the outer section318enclosing the end321of the core312, such that the outer section318around the end321forms a part of the exterior of the enclosure324around the entire perimeter of the enclosure324adjacent the end321, as best shown inFIGS. 39-41.

In another exemplary embodiment of the implement300illustrated inFIGS. 42-47, the outer sections318of the first portion316are each formed with a locating feature that in the illustrated exemplary embodiment takes the form of a recess340at each end of the outer section318. The recess340extends along at least a part of an optionally the entire perimeter of the end of the outer section318and forms a sealing and locating feature for the placement of the first portion316/outer sections318within the mold for forming the second portion322around the core312and first portion316. Thus, the recess340effectively separates the outer sections318from the second portion322when formed around the core312, with the recess340remaining between the outer sections318and the second portion322when forming the enclosure324around the core312, as best shown inFIGS. 45-47. Further, recess340can additionally be located in other areas of the first portion316, such as along the edges342of the outer sections318extending parallel to the long axis of the core312.

In still another exemplary embodiment of the implement300illustrated inFIGS. 48-53, the core312can be formed of multiple rods, cores or members350that are at least partially enclosed within the first portion316. The members350are oriented relative to one another, and optionally parallel to one another in the illustrated exemplary embodiment, and are spaced from one another as they extend between the outer sections318and the inner section320. The cross-sectional shape of the outer sections318and inner section320of the first portion316and the second portion322can vary as necessary to accommodate the members350to form an enclosure around the members350, but in the illustrated exemplary embodiment, the first portion316and second portion322form a rectangular cross-sectional enclosure324around the members350.

Further, in alternative embodiments, any of the features and/or constructions of the previously described embodiments can be combined with one another to form additional embodiments of the invention.

Various other embodiments of the present disclosure are contemplated as being within the scope of the filed claims particularly pointing out and distinctly claiming the subject matter regarded as the invention.