Medical Implant Delivery System and Method and an Implant Having a Detachable Marking Section

Abstract

Embodiments of the invention are directed to a caddy configured to receive medical implants coupled to respective holders. The medical implants and holders may be oriented and/or located in the caddy based on one or more of size, shape, and other configuration of the medical implants and holders and the openings in the caddy through which the medical implants are received. Another embodiment of the invention includes a medical implant having an implant body portion and a detachable marking portion that is connected to the implant body portion by a frangible region structured to provide selective separation of the implant body portion from the detachable marking portion upon application of a force or torque to the implant body portion, and the detachable marking portion including one or more markings that correspond to identifying information associated with features or characteristics of the implant body portion.

What is claimed: 
     
         1 . A caddy configured to receive a medical implant coupled to a holder, the caddy comprising:
 a substantially planar top element having a top surface, a bottom surface, and an opening that extends through the substantially planar top element from the top surface to the bottom surface; and   a support structure coupled to the substantially planar top element on the bottom surface such that the support structure provides a volume adjacent to the bottom surface configured to allow circulation of sterilization substances within the volume; and   wherein the opening through the substantially planar top element has a non-symmetrical shape about at least one primary axis of the substantially planar top element, wherein the opening is configured to receive a substantially matching non-symmetrically shaped holder to which a medical implant is coupled, such that when the holder and the medical implant are received in the opening through the substantially planar top element, the holder is aligned in a predetermined orientation relative to the substantially planar top element.   
     
     
         2 . The caddy of  claim 1  wherein the opening through the substantially planar top element is non-symmetrical about only one primary axis in the plane of the substantially planar top element. 
     
     
         3 . The caddy of  claim 1  wherein the opening through the substantially planar top element is non-symmetrical about two axes in the plane of the substantially planar top element. 
     
     
         4 . The caddy of  claim 1  wherein the opening through the substantially planar top element is substantially the shape of a keyhole. 
     
     
         5 . The caddy of  claim 1  wherein the opening through the substantially planar top element has a multiple-component shape comprising:
 a substantially round opening component configured to receive at least a portion of a substantially round medical implant; and 
 a substantially rectangular opening component that intersects with the substantially round opening component, the substantially rectangular opening component having one side dimension that is less than the diameter of the substantially round opening component, the substantially rectangular opening component being configured to receive at least a portion of the holder. 
 
     
     
         6 . The caddy of  claim 1  wherein the substantially planar top element includes two or more non-symmetrically shaped openings configured to receive two or more respectively and substantially matching non-symmetrically shaped holders to which medical implants are coupled, such that when the holders and medical implants are received in the openings through the substantially planar top element, the holders are aligned in predetermined orientations relative to the substantially planar top element. 
     
     
         7 . The caddy of  claim 6  wherein the respective predetermined orientations align the two or more non-symmetrically shaped holders in substantially similar orientations. 
     
     
         8 . The caddy of  claim 6  wherein the two or more non-symmetrically shaped openings include openings of different sizes configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, wherein each non-symmetrically shaped holder to which a medical implant is coupled can only be received in one size of non-symmetrically shaped opening in the caddy. 
     
     
         9 . The caddy of  claim 6  wherein the two or more non-symmetrically shaped openings include openings of different shapes configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, wherein each non-symmetrically shaped holder to which a medical implant is coupled can only be received in one shape of non-symmetrically shaped opening in the caddy. 
     
     
         10 . The caddy of  claim 1  wherein the substantially planar top element includes two or more non-symmetrically shaped openings configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, such that when the holders and medical implants are received in the openings through the substantially planar top element, the holders are positioned at predetermined locations in the caddy. 
     
     
         11 . The caddy of  claim 10  wherein the two or more non-symmetrically shaped openings include openings of different sizes configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, and wherein the openings of different sizes correlate with medical implants of different sizes. 
     
     
         12 . The caddy of  claim 10  wherein the two or more non-symmetrically shaped openings include openings of different shapes configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, and wherein the openings of different shapes correlate with medical implants of different sizes. 
     
     
         13 . The caddy of  claim 10  wherein the two or more non-symmetrically shaped openings include openings of different sizes configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, and wherein the openings of different sizes correlate with medical implants of different types. 
     
     
         14 . The caddy of  claim 10  wherein the two or more non-symmetrically shaped openings include openings of different shapes configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, and wherein the openings of different shapes correlate with medical implants of different types. 
     
     
         15 . The caddy of  claim 10  wherein the two or more non-symmetrically shaped openings include openings of different sizes configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, wherein each non-symmetrically shaped holder to which a medical implant is coupled can only be received in one size of non-symmetrically shaped opening in the caddy. 
     
     
         16 . The caddy of  claim 10  wherein the two or more non-symmetrically shaped openings include openings of different shapes configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, wherein each non-symmetrically shaped holder to which a medical implant is coupled can only be received in one shape of non-symmetrically shaped opening in the caddy. 
     
     
         17 . A medical implant delivery system, comprising: a medical implant;
 a holder coupled to the medical implant and having a first area and a second area, wherein the second area is at least in part substantially perpendicular to the first area;   one or more markings on the first area that include basic identifying information associated with the medical implant; and   a caddy configured to receive the holder coupled to the medical implant, the caddy comprising:
 a substantially planar top element having a top surface, a bottom surface, and an opening that extends through the substantially planar top element from the top surface to the bottom surface, and 
 a support structure coupled to the substantially planar top element on the bottom surface side such that the support structure provides a volume adjacent to the bottom surface configured to allow circulation of sterilization substances within the volume, and 
 wherein the opening through the substantially planar top element has a non-symmetrical shape about at least one primary axis of the substantially planar top element, wherein the opening is configured to receive a substantially matching non-symmetrically shaped holder to which a medical implant is coupled, such that when the holder and medical implant are received in the opening through the substantially planar top element, the holder is aligned in a predetermined orientation relative to the substantially planar top element. 
   
     
     
         18 . The medical implant delivery system of  claim 17 , further comprising one or more markings on the second area that include identifying information associated with the medical implant that is of greater detail than the basic identifying information. 
     
     
         19 . The medical implant delivery system of  claim 17  wherein the caddy is configured to display the first area markings of the holder when the holder is received in the caddy. 
     
     
         20 . The medical implant delivery system of  claim 17  wherein the substantially planar top element includes two or more types of non-symmetrically shaped openings of different types configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, wherein each type of non-symmetrically shaped holder to which a medical implant is coupled can only be received in one type of non-symmetrically shaped opening in the caddy. 
     
     
         21 . A method of providing a medical implant assembly, the method comprising: manufacturing a medical implant;
 providing a holder for the medical implant that has a first area and a second area, wherein the second area is at least in part substantially perpendicular to the first area;   coupling the holder to the medical implant;   providing a caddy configured to receive the holder coupled to the medical implant and to display markings on the first area of the holder, the caddy comprising:
 a substantially planar top element having a top surface, a bottom surface, and an opening that extends through the substantially planar top element from the top surface to the bottom surface, and 
 a support structure coupled to the substantially planar top element on the bottom surface side such that the support structure provides a volume adjacent to the bottom surface configured to allow circulation of sterilization substances within the volume, and 
 wherein the opening through the substantially planar top element has a non-symmetrical shape about at least one primary axis of the substantially planar top element, wherein the opening is configured to receive a matching non-symmetrically shaped holder to which a medical implant is coupled, such that when the holder and medical implant are received in the opening through the substantially planar top element, the holder is aligned in a predetermined orientation relative to the substantially planar top element; and
 shipping the medical implant assembly. 
 
   
     
     
         22 . The method of  claim 21  wherein the act of providing a caddy includes providing a caddy wherein the substantially planar top element includes two or more types of non-symmetrically shaped openings of different types configured to receive two or more respectively matching non-symmetrically shaped holders to which medical implants are coupled, wherein each type of non-symmetrically shaped holder to which a medical implant is coupled can only be received in one type of non-symmetrically shaped opening in the caddy. 
     
     
         23 . A method of providing a medical implant assembly, the method comprising: manufacturing a medical implant;
 packaging the medical implant with a holder, wherein the medical implant and the holder are contained within a package, and wherein the holder is marked with identifying information;   sterilizing the medical implant and the holder while packaged;   opening the package in which the medical implant and holder are packaged; placing the medical implant and the holder into a caddy; and   re-sterilizing the medical implant and the holder while in the caddy.   
     
     
         24 . The method of  claim 23  wherein the act of packaging includes packaging the holder marked with identifying information wherein the identifying information includes a device identifier and a production identifier. 
     
     
         25 . The method of  claim 24  wherein the device identifier includes information that identifies the labeler of the medical implant and a specific version or model of the medical implant. 
     
     
         26 . The method of  claim 24  wherein the production identifier includes unique information about the medical implant. 
     
     
         27 . The method of  claim 26  wherein the unique information includes one or more of a lot or batch number within which the medical implant was manufactured, a serial number of a specific medical implant, an expiration date of the medical implant, a date the medical implant was manufactured, and an identification code required for a human cell, tissue, or cellular and tissue-based product regulated as a device. 
     
     
         28 . The method of  claim 23  wherein the caddy is configured to receive the holder when coupled to the medical implant, the caddy comprising:
 a substantially planar top element having a top surface, a bottom surface, and an opening that extends through the substantially planar top element from the top surface to the bottom surface, and 
 a support structure coupled to the substantially planar top element on the bottom surface side such that the support structure provides a volume adjacent to the bottom surface configured to allow circulation of sterilization substances within the volume, and 
 wherein the opening through the substantially planar top element has a non-symmetrical shape about at least one primary axis of the substantially planar top element, wherein the opening is configured to receive a matching non-symmetrically shaped holder to which a medical implant is coupled, such that when the holder and medical implant are received in the opening through the substantially planar top element, the holder is aligned in a predetermined orientation relative to the substantially planar top element. 
 
     
     
         29 - 40 . (canceled)