Reusable surgical implement

Abstract

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.

Claims

1. A reusable surgical implement comprising: a) a core formed of a rod of a shape memory material; and b) an enclosure formed around the core, wherein the enclosure includes a first portion having an inner section and a number of outer sections joined by the inner section; wherein the inner section and the outer sections are oriented at an angle of 180 with respect to one another, such that the inner section and the outer sections enclose portions and do not enclose portions of the core at an angle of 180 with respect to one another, and wherein the enclosure further comprises a second portion that completely covers the inner section and abuts the outer sections.

2. The reusable surgical implement of claim 1, wherein the inner section and the outer sections have different thicknesses.

3. The reusable surgical implement of claim 1, wherein the inner section does not completely enclose the core.

4. The reusable surgical implement of claim 1, wherein the outer sections do not completely enclose the core.

5. The reusable surgical implement of claim 1, wherein the outer sections and the second portion form a seamless exterior surface for the enclosure.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) The drawings illustrate the best mode currently contemplated of practicing the present invention.

(2) In the drawings:

(3) FIG. 1 is an isometric view of a one exemplary embodiment of a reusable surgical implement constructed according to the present disclosure;

(4) FIG. 2 is a an exploded view of the trial implant of FIG. 1;

(5) FIG. 3 is a side elevation view of the trial implant of FIG. 1;

(6) FIG. 4 is an exploded view of the trial implant of FIG. 3;

(7) FIG. 5 is a top plan view of the trial implant of FIG. 1;

(8) FIG. 6 is a bottom plan view of the trial implant of FIG. 1;

(9) FIG. 7 is an end elevation view of the trial implant of FIG. 1;

(10) FIG. 8 is an exploded view of the trial implant of FIG. 7;

(11) FIG. 9 is an isometric view of another exemplary embodiment of a reusable surgical implement constructed according to the present disclosure;

(12) FIG. 10 is a side elevation view of the implement of FIG. 9;

(13) FIG. 11 is a cross-sectional view along line 11-11 of FIG. 10;

(14) FIG. 12 is an isometric view of the implement of FIG. 9 after a first molding step;

(15) FIG. 13 is a side elevation view of the implement of FIG. 12;

(16) FIG. 14 is a cross-sectional view along line 14-14 of FIG. 13;

(17) FIG. 15 is an isometric view of the implement of FIG. 9 after a second molding step;

(18) FIG. 16 is a side elevation view of the implement of FIG. 15;

(19) FIG. 17 is a cross-sectional view along line 17-17 of FIG. 16;

(20) FIG. 18 is an isometric view of still another exemplary embodiment of an implement constructed according to the present disclosure;

(21) FIG. 19 is a side elevation view of the implement of FIG. 18;

(22) FIG. 20 is an isometric view of the implement of FIG. 18 after a first molding step;

(23) FIG. 21 is a side elevation view of the implement of FIG. 20;

(24) FIG. 22 is an isometric view of the implement of FIG. 18 after a second molding step;

(25) FIG. 23 is a side elevation view of the implement of FIG. 22;

(26) FIG. 24 is an isometric view of a further exemplary embodiment after a first molding step;

(27) FIG. 25 is a side plan view of the embodiment of FIG. 24;

(28) FIG. 26 is a cross-sectional view along line 26-26 of FIG. 25;

(29) FIG. 27 is an isometric view of the embodiment of FIG. 24 after a second molding step;

(30) FIG. 28 is a top plan view of the embodiment of FIG. 27;

(31) FIG. 29 is a cross-sectional view along line 29-29 of FIG. 28;

(32) FIG. 30 is an isometric view of still a further exemplary embodiment after a first molding step;

(33) FIG. 31 is a side plan view of the embodiment of FIG. 30;

(34) FIG. 32 is a cross-sectional view along line 32-32 of FIG. 31;

(35) FIG. 33 is an isometric view of the embodiment of FIG. 30 after a second molding step;

(36) FIG. 34 is a top plan view of the embodiment of FIG. 33;

(37) FIG. 35 is a cross-sectional view along line 35-35 of FIG. 34;

(38) FIG. 36 is an isometric view of still another exemplary embodiment after a first molding step;

(39) FIG. 37 is a side plan view of the embodiment of FIG. 36;

(40) FIG. 38 is a cross-sectional view along line 38-38 of FIG. 37;

(41) FIG. 39 is an isometric view of the embodiment of FIG. 36 after a second molding step;

(42) FIG. 40 is a top plan view of the embodiment of FIG. 39;

(43) FIG. 41 is a cross-sectional view along line 41-41 of FIG. 40;

(44) FIG. 42 is an isometric view of a further exemplary embodiment after a first molding step;

(45) FIG. 43 is a side plan view of the embodiment of FIG. 42;

(46) FIG. 44 is a cross-sectional view along line 44-44 of FIG. 43;

(47) FIG. 45 is an isometric view of the embodiment of FIG. 42 after a second molding step;

(48) FIG. 46 is a top plan view of the embodiment of FIG. 45;

(49) FIG. 47 is a cross-sectional view along line 47-47 of FIG. 46;

(50) FIG. 48 is an isometric view of still another exemplary embodiment after a first molding step;

(51) FIG. 49 is a side plan view of the embodiment of FIG. 48;

(52) FIG. 50 is a cross-sectional view along line 50-50 of FIG. 49;

(53) FIG. 51 is an isometric view of the embodiment of FIG. 48 after a second molding step;

(54) FIG. 52 is a top plan view of the embodiment of FIG. 51;

(55) FIG. 53 is a cross-sectional view along line 53-53 of FIG. 52.

DETAILED DESCRIPTION OF THE DRAWINGS

(56) 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 at 10 in FIG. 1. As best shown in FIGS. 1-8, the implant 10 is formed of a central core 12 and an enclosure 14 disposed around the core 12 formed of an upper portion 16 and a lower portion 18. In the illustrated embodiment, the implant 10 is formed with a pre-curved shape, though other configurations for the implant 10 as also contemplated as being within the scope of the disclosure of the present invention.

(57) Referring now to FIGS. 2, 4 and 8, though any suitable shape for the core 12 can be utilized, in the illustrated embodiment the core 12 is formed with a generally rectangular configuration with a first end 20 and a second end 22 joined by opposed sides 24. In the illustrated embodiment the core 12 is also formed to be generally rectangular in cross-section with a pair of generally flat opposed surfaces 26 joining the ends 20, 22 and the sides 24, though any suitable cross-sectional shape can be utilized to impart the desired amount of flexibility to the core 12. The core 12 is shaped in any suitable machine and/or process to provide the desired shape for the core 12, which may include apertures or other features therein, as desired.

(58) The material forming the core 12 is selected to be a generally rigid, but flexible material that can be altered in shape by applying a physical force to the core 12. Once the force is removed, the core 12 remains in the shape to which it was altered by the applied force. In one embodiment of the core 12, the core 12 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.

(59) The enclosure 14 is disposed around the core 12 and each portion 16 and 18 of the enclosure 14 is formed of a biologically inert and flexible material that can conform to the shape of the core 12 in any configuration for the core 12. In one embodiment, the material forming the portions 16 and 18 of the enclosure 14 is a silicone, such as a silicone rubber, including a high consistency rubber (HCR) or liquid silicone rubber (LSR).

(60) The portions 16 and 18 of the enclosure 14 are formed with features 26 that 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 features 26 can include apertures 28 and notches 30, among others. The apertures 28 can extend completely through the respective portions 16 and 18 without intersecting the core 12, thereby preserving the integrity of the enclosure 14 around the core 12. Further, the shape of the portions 16 and 18 forming the enclosure 14 can be shaped as desired to approximate the shape of the actual implant. Also, the shape of the portions 16 and 18 can be selected independently of the shape of the core 12, or to conform to the shape of the core 12, as desired.

(61) In one embodiment, the trial implant 10 is formed by initially forming the core 12 of the desired material in any suitable manner, such as by extruding or molding the material into the desired shape for the core 12. The core 12 is then placed within a suitable mold to enable the material selected form either the upper portion 16 or the lower portion 18 to be introduced into the mold containing the core 12 and form a portion of the enclosure 14 on or over the core 12 that contains the desired features 26. Any suitable molding process can be utilized to form the upper portion 16 or lower portion 18 around the core 12.

(62) Subsequently, the core 12 and the portion 16 or 18 molded onto or over the core 12 are removed or transferred from the first mold and placed within a separate or second mold used to form the other of the upper portion 16 or the lower portion 18 on or over the core 12 in connection with the first portion 16 or 18 and with the desired features 26. The material selected to form the other portion 16 or 18 can be selected to be the same or different than the material used to form the first portion 16 or 18, to provide the desired attributes to the enclosure 14 and the implant 10, so long as the materials forming the upper portion 16 and lower portion 18 are capable of mating, co-mingling or otherwise joining to one another in the molding process to form the enclosure 14 around the core 12. Additionally, suitable materials can be applied to one or both of the portions 16 and/or 18 to properly affix the portions 16 and 18 to one another, either during molding of the portions 16 and 18 to one another, or when affixing pre-molded portions 16 and 18 to one another around the core 12.

(63) In alternative embodiments, the portions 16 and 18 can be formed subsequently or simultaneously within a single mold in any suitable molding process.

(64) In use, the implant 10 in a sterile condition is placed within the body of a patient and bent, such as by hand, to conform the implant 10 to 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 features 26 formed in the implant 10. The implant 10 can 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.

(65) Once removed from the body, the implant 10 can be cleaned and sterilized for additional uses. When sterilized, the heat used to sterilize the implant 10 can also activate the material forming the core 12 to return the implant 10 to its initial pre-bent configuration or shape, thus making the implant 10 ready for use once the sterilization process has been completed.

(66) As best shown in FIGS. 9-17, a second exemplary embodiment of the implement is formed as a rod template 100 having a central core 12 and an enclosure 14 disposed around the core 12 formed of a first component or portion(s) 16 and a second component or portion(s) 18. In the illustrated embodiment, the rod template 100 is formed similarly to the implant 10, and can be generally straight, though other configurations for the rod template 100 are also contemplated as being within the scope of the disclosure of the present invention.

(67) Though any suitable shape for the core 12 can be utilized, in the illustrated embodiment the core 12 is formed with a generally flat rectangular or cylindrical cross-sectional shape with a first end 20 and a second end 22 joined by opposed sides 24, though any suitable cross-sectional shape can be utilized to impart the desired amount of flexibility to the core 12. The core 12 is shaped in any suitable machine and/or process to provide the desired shape for the core 12, which may include apertures or other features therein, as desired.

(68) The material forming the core 12 is selected to be a generally rigid, but flexible material that can be altered in shape by applying a physical force to the core 12. Once the force is removed, the core 12 remains in the shape to which it was altered by the applied force. In one embodiment of the core 12, the core 12 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.

(69) The enclosure 14 is disposed around the core 12 and each portion 16 and 18 of the enclosure 14 is formed of a biologically inert and flexible material that can conform to the shape of the core 12 in any configuration for the core 12. In one embodiment, the material forming the portions 16 and 18 of the enclosure 14 is a silicone, such as a silicone rubber, including a high consistency rubber (HCR) or a liquid silicone rubber (LSR).

(70) The portions 16 and 18 of the enclosure 14 are formed with any features (not shown) desired to enhance the utility of the implement 100 when 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 portions 16 and 18 without intersecting the core 12, thereby preserving the integrity of the enclosure 14 around the core 12. Further, the shape of the portions 16 and 18 forming the enclosure 14 can be shaped as desired. Also, the shape of the portions 16 and 18 can be selected independently of the shape of the core 12, or to conform to the shape of the core 12, as desired.

(71) In the illustrated embodiment, the implement 100 is formed by initially forming the core 12 of the desired material in any suitable manner, such as by extruding or molding the material into the desired shape for the core 12, as shown in FIGS. 9-11. The core 12 is then placed within a suitable mold to enable the material selected to form the first portion 16 to be introduced into the mold containing the core 12 and form a portion of the enclosure 14 on or over the core 12 that contains the desired features. Any suitable molding process can be utilized to form the first portion 16 around the core 12, 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 in FIGS. 12-14, the first portion 16 constitutes a number of spaced sections 102 disposed along the length of the core 12.

(72) Subsequently, the core 12 and the first portion 16 molded onto or over the core 12 are removed or transferred from the first mold and placed within a separate or second mold used to form the other of the second portion 18 on or over the core 12 in connection with the first portion 16 and with the desired features. The material selected to form the second portion 18 can be selected to be the same or different in one or more respects or attributes than the material used to form the first portion 16, in order to provide the desired attributes to the enclosure 14 and the implement 100, so long as the materials forming the first portion 16 and second portion 18 are capable of mating, co-mingling or otherwise joining to one another in the molding process used to form the enclosure 14 around the core 12, which can be the same or different that the process used to form the first section 16. Additionally, suitable materials can be applied to one or both of the portions 16 and/or 18 to properly affix the portions 16 and 18 to one another, either during molding of the portions 16 and 18 to one another, or when affixing pre-molded portions 16 and 18 to one another around the core 12.

(73) In alternative embodiments, the portions 16 and 18 can be formed subsequently or simultaneously within a single mold in any suitable molding process. In the illustrated embodiment, the second portion 18 includes a number of spaced sections 104 disposed along the length of the core 12 alternating in a sequential manner between and joining the sections 102 to form the enclosure 14. In this embodiment, as shown in FIGS. 15-17, the sections 102 and 104 form a seamless enclosure 14 around the core 12 complete with end caps 106 disposed over each end 20,22 of the core 12, which can be molded with either of the sections 102 or 104, or separately therefrom. The seamless enclosure 14 moves and/or flexes with the core 12 to retain the core 12 encased within the enclosure 14, such that the sterilization of the implement 100 does not contact the core 12.

(74) A third embodiment of the implement 200 shown in FIGS. 18-23 illustrates the implement 200 as a flex driver. The implement 200 includes a flexible core 212, such as a spring or coil, with a pair of opposed ends 220 and 222 that, 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 ends 220 and 222 define a central section 224 therebetween, as best shown in FIGS. 18-21. In the embodiment shown in FIGS. 20 and 21, the first portion 216, which can be formed similarly to the first portion 16 in the prior embodiment, is molded onto the core 212 in a first mold in a first molding step over at least approximately one half of the central section 224 in a suitable process, such as those cited as examples for the molding of the first portion 16 in the prior embodiment. In this process, however, the ends 220 and 222 can function as stops for the flow of the material forming the first portion 216 at each end 220 and 222.

(75) Subsequently, the core 212 can be removed from the first mold for positioning in a second mold, or simply rotated within the first mold to expose the uncovered portion 226 of the central section 224 within the second mold. One properly positioned, the second portion 218 can be formed over the uncovered section 226 to form the enclosure 214 over the central section 224 with the first portion 216 and without end caps, leaving the ends 220,222 exposed. In this configuration, the core 212 can be flexed as desired to properly orient the ends 220,222 to utilize the implement 200, but the enclosure 214 remains in close conformance with the core 212 to prevent debris from becoming positioned between the enclosure 214 and the core 212, and to limit the exposure of the core 212 to the sterilization environment when being sterilized for subsequent uses.

(76) In alternative embodiments for either embodiment of the implement 100, 200, the process for molding the first portion 16, 216 and/or second portion 18, 218 can be performed in any number of separate molding steps in order to form the enclosure 14, 214 on the core 12,212 with the desired appearance, attributes or other characteristics with any desired number and/or types of different materials forming the portions 16,216 and/or 18,218.

(77) Additional molding processes are also available for forming the enclosure 14, 14 or 214 around the core 12, 12 or 212. 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.

(78) Looking now at FIGS. 24-29, in an alternative exemplary embodiment, the implement 300 includes a core 312, which is illustrated as an elongate rod having a circular cross-section but can have any desired cross-sectional shape, has a first portion 316 of a flexible and inert material molded or otherwise formed around the core 312 in a first molding or forming step. As best shown in FIGS. 24-26, after the first molding step, the first portion 316 formed in the step includes a pair of outer sections 318 spaced inwardly from opposed ends of the core 312 that are joined by an inner section 320. The inner section 320 is integrally joined to one end of each outer section 318 in order to form a continuous molded piece around the core 312, which can optionally encircle the core 312 or leave certain portions of the core 312 uncovered. For example, in the illustrated exemplary embodiment of FIG. 24-30, the outer sections 318 do not extend completely around the core 312 and have a semi-circular cross-section. Further, the inner section 320 also does not extend completely around the core 312 and has a semi-circular cross-section oriented 180 from the outer sections 318 to facilitate the joining of the inner section 320 to the outer sections 318. The inner section 320 also has a thickness or radius that is less than that of the outer sections 318, such that the inner section 318 covers the portion of the core 312 where the inner section is located, but does not extend outwardly from the core 312 the same distance as the outer sections 318.

(79) In FIGS. 27-29, in another exemplary embodiment of the implement 300 after a second molding or forming step a second portion 322 formed of a flexible and inert material is molded or formed around and over the first portion 316. The second portion 322 forms an enclosure 324 around the core 312 in conjunction with the first portion 316. The second portion 322 is formed to be complementary to the outer sections 318 of the first portion 316 such that the enclosure 324 has an exterior surface 326 formed of the outer surfaces of the outer sections 318 of the first portion 316 and the second portion 322. In the illustrated exemplary embodiment of FIGS. 27-29, the second portion 322 completely covers the inner section 320 of the first portion 316 and forms a cylindrical enclosure 324 around the exposed ends 321 of the core 312 and inner section 320, with a complementary radius to the outer sections 318, such that the outer sections 318 form exposed panels 327 on the enclosure 324 within the second portion 322. When formed, the material forming the second portion 322 bonds and/or engages the first portion 316 in a manner to form a seamless enclosure 324 around the core 312.

(80) Referring now to FIGS. 30-35, in another exemplary embodiment of the implement 300 the first portion 316 is formed around the core 312 with a number of inner sections 320 joining adjacent outer sections 318, with an outer section(s) 318 that encloses a portion of an end 321 of the core 312, as best shown in FIGS. 30-32. The outer section(s) 318 formed over the end(s) 321 includes a cap 328 that extends past the end 321 and terminates in an end surface 330 that can be flat. When the second portion 322 is formed or molded around the core 312 and the first portion 316 to form the enclosure 324, the second portion 322 abuts the cap 328 formed by the outer section 318 and terminates in a flat surface 332 that is coplanar with the flat surface 330 on the cap 328.

(81) Looking now at FIGS. 36-41, in another exemplary illustrated embodiment of the implement 300, the first portion 316 is formed around the core 312 with a number of inner sections 320 joining adjacent outer sections 318, and with an outer section(s) 318 that encloses an end 321 of the core 312, as best shown in FIGS. 36-38. The second portion 322 is formed around the core 312 and the first portion 316 as in previous embodiments, but the second portion 322 abuts the outer section 318 enclosing the end 321 of the core 312, such that the outer section 318 around the end 321 forms a part of the exterior of the enclosure 324 around the entire perimeter of the enclosure 324 adjacent the end 321, as best shown in FIGS. 39-41.

(82) In another exemplary embodiment of the implement 300 illustrated in FIGS. 42-47, the outer sections 318 of the first portion 316 are each formed with a locating feature that in the illustrated exemplary embodiment takes the form of a recess 340 at each end of the outer section 318. The recess 340 extends along at least a part of an optionally the entire perimeter of the end of the outer section 318 and forms a sealing and locating feature for the placement of the first portion 316/outer sections 318 within the mold for forming the second portion 322 around the core 312 and first portion 316. Thus, the recess 340 effectively separates the outer sections 318 from the second portion 322 when formed around the core 312, with the recess 340 remaining between the outer sections 318 and the second portion 322 when forming the enclosure 324 around the core 312, as best shown in FIGS. 45-47. Further, recess 340 can additionally be located in other areas of the first portion 316, such as along the edges 342 of the outer sections 318 extending parallel to the long axis of the core 312.

(83) In still another exemplary embodiment of the implement 300 illustrated in FIGS. 48-53, the core 312 can be formed of multiple rods, cores or members 350 that are at least partially enclosed within the first portion 316. The members 350 are 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 sections 318 and the inner section 320. The cross-sectional shape of the outer sections 318 and inner section 320 of the first portion 316 and the second portion 322 can vary as necessary to accommodate the members 350 to form an enclosure around the members 350, but in the illustrated exemplary embodiment, the first portion 316 and second portion 322 form a rectangular cross-sectional enclosure 324 around the members 350.

(84) 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.

(85) 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.