C.29 IMPLANT MODULES

C.29.1 Generic Implant Template Modules

This section describes the specific modules for the Generic Implant Template IOD.

C.29.1.1 Generic Implant Template Description Module

Table C.29.1.1-1 defines the general Attributes of the Generic Implant Template Description Module.

Table C.29.1.1-1 GENERIC IMPLANT TEMPLATE DESCRIPTION MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
Manufacturer (0008,0070) 1 Name of the manufacturer that produces the implant.
Frame of Reference UID (0020,0052) 1 Defines a 3D Frame of Reference for this component.
Implant Name (0022,1095) 1 The (product) name of the implant.
Implant Size (0068,6210) 1C The size descriptor of the component. Required if the component exists in different sizes and the size number is not part of the name or identifier. May be present otherwise. See C.29.1.1.1.1 for details.
Implant Part Number (0022,1097) 1 The (product) identifier of the implant.
Implant Template Version (0068,6221) 1 The version code of the implant template. If Implant Type (0068,6223) is DERIVED, this shall have the same value as the Implant Template Version (0068,6221) of the manufacturer’s implant template from which this instance was derived.
Replaced Implant Template Sequence (0068,6222) 1C Reference to the Implant Template that is replaced by this template. Only a single Item shall be included in this sequence. Required if this Instance replaces another Instance.
>Include ‘SOP Instance Reference Macro’ Table 10-11
Implant Type (0068,6223) 1 Indicates whether the Implant Template is derived from another Implant Template. Enumerated Values: ORIGINAL DERIVED
Original Implant Template Sequence (0068,6225) 1C Reference to the Implant Template Instance with Implant Type (0068,6223) ORIGINAL from which this Instance was ultimately derived. Only a single Item shall be included in this sequence. Required if Implant Type (0068,6223) is DERIVED.
>Include ‘SOP Instance Reference Macro’ Table 10-11
Derivation Implant Template Sequence (0068,6224) 1C Reference to Implant Template Instance from which this Instance was directly derived. Only a single Item shall be included in this sequence. Required if Implant Type (0068,6223) is DERIVED.
>Include ‘SOP Instance Reference Macro’ Table 10-11
Effective DateTime (0068,6226) 1 Date and time from which this Instance is or will be valid.
Implant Target Anatomy Sequence (0068,6230) 3 Sequence that identifies the anatomical region the implant is to be implanted to. One or more Items are permitted in this sequence.
>Anatomic Region Sequence (0008,2218) 1 Sequence that identifies the anatomic region of interest in this Instance (i.e. external anatomy, surface anatomy, or general region of the body). Only a single Item shall be included in this sequence.
>>Include ‘Code Sequence Macro’ Table 8.8-1 Defined Context ID 7304 Implant Target Anatomy
Notification From Manufacturer Sequence (0068,6265) 1C Information from the manufacturer concerning a critical notification, recall, or discontinuation of the implant or implant template. One or more Items shall be included in this sequence. Required if such information has been issued.
>Information Issue DateTime (0068,6270) 1 Date and Time the information was issued.
>Information Summary (0068,6280) 1 Summary of the information.
>Encapsulated Document (0042,0011) 3 The complete manufacturer notification describing the template. Encapsulated Document stream, containing a document encoded according to the MIME Type.
>MIME Type of Encapsulated Document (0042,0012) 1C The type of the encapsulated document stream described using the MIME Media Type (see RFC 2046). Enumerated Value shall be “application/pdf”. Required if Encapsulated Document (0042,0011) is present in this Sequence item.
Information From Manufacturer Sequence (0068,6260) 3 Information from Manufacturer other than described in Notification From Manufacturer Sequence (0068,6265). One or more Items shall be included in this sequence.
>Information Issue DateTime (0068,6270) 1 Date and Time the information was issued.
>Information Summary (0068,6280) 1 Summary of the information.
>Encapsulated Document (0042,0011) 3 Encapsulated Document stream, containing a document encoded according to the MIME Type. The complete manufacturer information.
>MIME Type of Encapsulated Document (0042,0012) 1C The type of the encapsulated document stream described using the MIME Media Type (see RFC 2046). Enumerated Value shall be “application/pdf”. Required if Encapsulated Document (0042,0011) is present in this Sequence item.
Implant Regulatory Disapproval Code Sequence (0068,62A0) 1C Sequence containing countries and regions in which the implant is not approved for usage. One or more Items shall be included in this sequence. Required if the implant has been disapproved in a country or a region.
>Include ‘Code Sequence Macro’ Table 8.8-1 Defined Context ID is 5001.
Overall Template Spatial Tolerance (0068,62A5) 2 Tolerance in mm applying to all distance measurements and spatial locations in this Implant Template.
Materials Code Sequence (0068,63A0) 1 A code sequence specifying the materials the implant was built from. One or more Items shall be included in this Sequence.
>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7300.
Coating Materials Code Sequence (0068,63A4) 1C A code sequence specifying the materials the implant is coated with. One or more Items shall be included in this Sequence. Required if the implant is coated.
>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7300.
Implant Type Code Sequence (0068,63A8) 1 Sequence containing a coded description of the type of implant the template reflects. Only a single Item shall be included in this sequence.
>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7307.
Fixation Method Code Sequence (0068,63AC) 1 The method that will be used to fixate the implant in the body. Only a single Item shall be included in this sequence.
>Include ‘Code Sequence Macro’ Table 8.8.1 Baseline Context ID 7310

C.29.1.1.1 Generic Implant Template Description Attribute Descriptions

C.29.1.1.1.1 Implant Size

The Implant Size (0068,6210) is the descriptor defined by the manufacturer to distinguish between different sizes of one kind of implant, e.g. size S/M/L/XL.

C.29.1.1.1.2 Frame of Reference

The Frame of Reference UID (0020,0052) Attribute is used as an identifier for spatial registration in 3D. The Frame Of Reference UID uniquely identifies the spatial frame of reference of all 3D models contained in an Implant Template UID Instance.

If the Frame Of Reference UIDs in two instances are identical, the contained 3D Models are defined in the same 3D space, i.e. require no additional registration.

C.29.1.2 Generic Implant Template 2D Drawings Module

Table C.29.1.2-1 defines the general Attributes of the Generic Implant Template 2D Drawings Module. This module contains all Attributes required for the inclusion of technical 2D drawings in an IOD, e.g. the Implant Template IOD. The module specification contains the definition of a subset of the HPGL plotter language that is used for the graphical definition of the drawings.

Table C.29.1.2-1 GENERIC IMPLANT TEMPLATE 2D DRAWINGS MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
HPGL Document Sequence (0068,62C0) 1 The 2D template representations of this implant. One or more Items shall be included in this sequence.
>HPGL Document ID (0068,62D0) 1 Identification number of the HPGL Document. Uniquely identifies an HPGL Document within this SOP instance. The value shall start at 1, and increase monotonically by 1.
>HPGL Document Label (0068,62D5) 3 Label describing the document.
>View Orientation Code Sequence (0068,62E0) 1 Coded description of the direction of view represented by this 2D template. Only a single Item shall be included in this sequence.
>>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7302.
>View Orientation Modifier (0068,62F0) 3 View Orientation Modifier.
>>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7303.
>HPGL Document Scaling (0068,62F2) 1 Conversion factor (real world mm/printed mm) See C.29.1.2.1.1.
>HPGL Document (0068,6300) 1 The HPGL document as a byte stream. See C.29.1.2.1.2.
>HPGL Contour Pen Number (0068,6310) 1 Numeric ID of the pen used in the encapsulated HPGL document for outlines.
>HPGL Pen Sequence (0068,6320) 1 Labels for each pen used in the encapsulated HPGL Document. One or more Items shall be included in this sequence. Shall contain one item per pen used in the HPGL document.
>>HPGL Pen Number (0068,6330) 1 Numeric ID of the pen in the HPGL document
>>HPGL Pen Label (0068,6340) 1 Label of the pen.
>>HPGL Pen Description (0068,6345) 3 Description of the kind of information drawn with the pen.
>Recommended Rotation Point (0068,6346) 1 Point around which the 2D template is rotated in manual planning, in HPGL coordinates.
>Bounding Rectangle (0068,6347) 1 HPGL coordinates of the smallest rectangle parallel to the paper axes that contains the whole drawing.

C.29.1.2.1 Generic Implant Template 2D Drawings Attribute Descriptions

C.29.1.2.1.1 HPGL Document Scaling and Coordinate System

HPGL Documents use integer coordinates based on a 25µm grid in the printing space – i.e. the paper to print on – rather than the object space. HPGL Document Scaling (0068,62F2) is used to scale the printed dimensions measured in millimeters to match the real dimensions of the implant measured in millimeters.

Notes: 1. For example, if HPGL Document Scaling is 2.5, then a line in HPGL that goes from (0,0) to (0,500) that is 12.5 mm long when printed represents 31.25 mm in the real world.

2. In HPGL, the origin of the printing space is placed in the lower left corner with the x-axis pointing to the right. No negative coordinates are allowed.

This Attribute does not compensate for any radiographic geometric magnification effect caused by the diverging X-ray beam in the projection patient images used for planning. Such compensation is the responsibility of the application based on calibration of the imaging process.

C.29.1.2.1.2 HPGL Document

The HPGL files encapsulated in the Attribute HPGL Document (0068,6300) is restricted to a subset of HPGL commands called DICOM-HPGL specified in this section.

C.29.1.2.1.2.1 Scope

The aim of DICOM-HPGL is to facilitate the storage of 2D template graphics in DICOM implant objects. DICOM-HPGL is a subset of HPGL-2 that is kept as minimal as possible to comply with the needs of 2D implant templates.

C.29.1.2.1.2.2 Syntax

DICOM-HPGL documents consist of valid HPGL commands terminated by a semicolon. Commands consist of a two-letter mnemonic and zero or more numeric parameters separated by commas. To separate between commands, line breaks (x0D, x0A or x0Dx0A) or whitespaces (x20) may be used but are not mandatory.

Only the following commands shall be used in a DICOM-HPGL document

Command Parameter Meaning
IN - Initalize.
PA [X,Y] Plot Absolute. The optional parameter assigns an initial position for the pen.
PC Pen Number, Red, Green, Blue Set Color of Pen with the given Pen Number. Colors are in RGB, intensities are encoded 0..255. The colors for pen number 0 shall be white and the color for pen number 1 shall be black. It is recommended to use only the pen numbers up to 255 to ensure compatibility with older HPGL-Viewers.
SP Pen Number Select Pen It is recommended to use only the pen numbers up to 255 to ensure compatibility with older HPGL-Viewers. Only pen numbers shall be used to which a color has been specified in a precedent PC command.
PU [X,Y,…[,X,Y]] Pen Up. The optional sequence of paired parameters describe subsequent pen motions after lifting the pen.
PD [X,Y,…[,X,Y]] Pen Down. The optional sequence of paired parameters describe subsequent pen motions after lowering the pen.

According to the parameter definition in HPGL, [] indicate optional parameters. The expression [X,Y,…[,X,Y]] indicates a sequence of arbitrary length of paired parameters X and Y. The commands and their parameters shall be interpreted as specified in the HP PCL/PJL Reference.

Note: This document can be obtained fromURL: http://h20000.www2.hp.com/bc/docs/support/SupportManual/bpl13211/bpl13211.pdf

The coordinates in a DICOM-HPGL document are absolute values with respect to the lower left corner of the drawing space. The units of length within HPGL are 25 µm with respect to pen movements in the drawing space.

The DICOM-HPGL Document shall be structured as shown in Figure C.29.1.2-1.

Figure X-1.2 shows an example for a DICOM-HPGL Document in plain text, (as byte stream) and plotted.

[pic]

Figure C.29.1.2-1 DICOM-HPGL Document

[pic]

Figure C.29.1.2-2DICOM-HPGL Document – Example

C.29.1.3 Generic Implant Template 3D Models Module

Table C.29.1.3-1 defines the general Attributes of the Generic Implant Template 3D Models Module. This module contains Attributes that add context and scaling information to surfaces specified in the Surface Mesh Module (C.27.1), for 3D Models in an Implant Template Instance.

Table C.29.1.3-1 GENERIC IMPLANT TEMPLATE 3D MODELS MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
Implant Template 3D Model Surface Number (0068,6350) 1 Surface Number (0066,0003) of the surface that represents the shape of the entire implant.
Surface Model Description Sequence (0068,6360) 1 The description of the Surface Model. One or more Items shall be included in this sequence. Shall contain one Item per Item in the Surface Sequence (0066,0002).
>Referenced Surface Number (0066,002C) 1 Reference to a Surface Number (0066,0003) present in the Surface Sequence (0066,0002).
>Surface Model Label (0068,6380) 1 Label for this surface.
Surface Model Scaling Factor (0068,6390) 1 Scaling factor (mm/Surface unit) See C.29.1.3.1.1.

C.29.1.3.1 Generic Implant Template 3D Models Attribute Descriptions

C.29.1.3.1.1 Surface Model Scaling Factor

Surface Model Scaling Factor (0068,6390) is used to scale dimensions of the surface mesh representation to match the real dimensions of the implant measured in millimeters.

This Attribute does not compensate for any radiographic geometric magnification effect caused by the diverging X-ray beam in the projection patient images used for planning. Such compensation is the responsibility of the application based on calibration of the imaging process.

C.29.1.4 Generic Implant Template Mating Features Module

Table C.29.1.4-1 defines the general Attributes of the Generic Implant Template Mating Features Module. This module adds coordinate systems that can be utilized to geometrically constrain mating of Implant Templates when planning the implantation of a modular implant.

Note: An Implant Template may contain 2D drawings of the described implant, 3D surface models of the described implant, or both. In this module mating features that constrain the geometric matching of implants in multi-component assemblies are specified. These geometric features (points and axes) can be specified in the 2D drawings as well as the 3D models. Mating features are grouped into mating feature sets (see PS3.17). Based on the existence of 2D drawings and/or 3D models in the Instance, either or both is possible. In this module, there are a number of conditions on attribute use to support the following cases:

Table C.29.1.4-1 GENERIC IMPLANT TEMPLATE MATING FEATURES MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
Mating Feature Sets Sequence (0068,63B0) 3 Mating feature sets used to combine the implant with other implants. One or more Items shall be included in this sequence.
>Mating Feature Set ID (0068,63C0) 1 Identification number of the set. Uniquely identifies a mating feature set within this SOP instance. The value shall start at 1, and increase monotonically by 1 for each Item.
>Mating Feature Set Label (0068,63D0) 1 Label of the set.
>Mating Feature Sequence (0068,63E0) 1 The mating features of the set. One or more Items shall be included in this sequence.
>>Mating Feature ID (0068,63F0) 1 Numeric ID of the mating feature. Uniquely identifies a mating feature within this Sequence Item.
>>3D Mating Point (0068,64C0) 1C Origin of the contact system. Required if 2D Mating Feature Coordinates Sequence (0068,6430) is not present and Implant Template 3D Model Surface Number (0068,6350) is present. May be present if 2D Mating Feature Coordinates Sequence (0068,6430) is present and Implant Template 3D Model Surface Number (0068,6350) is present. See C.29.1.4.1.1
>>3D Mating Axes (0068,64D0) 1C The Axes of contact described as direction cosines in the 3D coordinate system defined by the Frame Of Reference UID. Required if 3D Mating Point (0068,64C0) is present. See C.29.1.4.1.1
>>2D Mating Feature Coordinates Sequence (0068,6430) 1C Coordinates of the mating feature in the HPGL documents. One or more Items shall be included in this sequence. Required if 3D Mating Point (0068,64C0) is not present and HPGL Document Sequence (0068,62C0) is present. May be present if 3D Mating Point (0068,64C0) is present and HPGL Document Sequence (0068,62C0) is present.
>>>Referenced HPGL Document ID (0068,6440) 1 Value of the HPGL Document ID (0068,62D0) present in the HPGL Document Sequence (0068,62C0) that contains the 2D Drawing including the Mating Feature. Shall be unique within the sequence.
>>>2D Mating Point (0068,6450) 1 Origin of the contact system, in HPGL coordinates. See C.29.1.4.1.1
>>>2D Mating Axes (0068,6460) 1 Direction cosines of the contact system. See C.29.1.4.1.1
>>Mating Feature Degree of Freedom Sequence (0068,6400) 3 Degrees of freedom in this mating feature. One or more Items are permitted in this sequence. See C.29.1.4.1.2.
>>>Degree of Freedom ID (0068,6410) 1 Numeric ID of the degree of freedom. Uniquely identifies a degree of freedom within this Sequence Item. The value shall start at 1, and increase monotonically by 1 for each Item.
>>>Degree of Freedom Type (0068,6420) 1 Indicates the type of the degree of freedom. Enumerated Values: TRANSLATION ROTATION See C.29.1.4.1.2.
>>>2D Degree of Freedom Sequence (0068,6470) 1C Geometric specifications of the degrees of freedom for this HPGL Document. One or more Items shall be included in this sequence. Required if 2D Mating Feature Coordinates Sequence (0068,6430) is present. See C.29.1.4.1.2.
>>>>Referenced HPGL Document ID (0068,6440) 1 Value of the HPGL Document ID (0068,62D0) present in the HPGL Document Sequence (0068,62C0) that contains the 2D Drawing including the Mating Feature. See C.29.1.4.1.2. Shall be unique within the sequence.
>>>>2D Degree Of Freedom Axis (0068,64F0) 1 Direction cosines of the axis of the degree of freedom. See C.29.1.4.1.2.
>>>>Range of Freedom (0068,64A0) 1 Interval of freedom for this degree of freedom. See C.29.1.4.1.2.
>>>3D Degree Of Freedom Axis (0068,6490) 1C Direction cosines of the axis of the degree of freedom in the Frame of Reference of the template. See C.29.1.4.1.2. Required if 3D Mating Point (0068,64C0) is present.
>>>Range of Freedom (0068,64A0) 1C Two floating point numbers defining a value range for this degree of freedom. See C.29.1.4.1.2. Required if 3D Mating Point (0068,64C0) is present.

C.29.1.4.1 Generic Implant Template 2D Drawings Attribute Descriptions

C.29.1.4.1.1 Mating Features

These Attributes establish a Cartesian coordinate system relative to the Frame of Reference of the implant. When two implants are assembled using a pair of mating features, a rigid spatial registration can be established, that transforms one Frame of Reference so that the mating features align.

C.29.1.4.1.2 Degrees of Freedom

Mating Feature Degree of Freedom Sequence (0068,6400) is used to specify that a mating feature allows mating with another implant not only in one defined pose, but within a certain range of freedom. One sequence item specifies one degree of freedom that may be a rotation around or a translation along an arbitrary axis. The Degree of Freedom Type (0068,6420) specifies whether the degree of freedom describes a rotation or a translation.

The 3D coordinates of the axis of translation or rotation is specified by 3D Degree Of Freedom Axis (0068,6490) with respect to the Implant Template’s Frame of Reference as three-dimensional vector in x-y-z order. Range Of Freedom (0068,64A0) specifies an interval, in millimeters or degrees, by which this 3D coordinate system mating feature may be moved along or around the axis.

For each HPGL Document, the 2D Degree Of Freedom Axis (0068,64F0) may be specified as a 3D vector encoded in x-y-z order, where the z-coordinate is equal to the direction of projection, i.e., equal to the cross product of the x- and y-axis of the printing space. Range Of Freedom (0068,64A0) specifies an interval, in millimeters or degrees, by which the 3D coordinate system of this mating feature may be moved along or around the axis.

C.29.1.5 Generic Implant Template Planning Landmarks Module

Table C.29.1.5-1 defines the general Attributes of the Generic Implant Template Planning Landmarks Module. This module adds planning landmarks, i.e., geometric annotations that constrain implant template registration to anatomical features, to the Implant Template IOD.

Note: An Implant Template may contain 2D drawings from several viewpoints, 3D surface models, or both. The planning landmarks that are specified with this module may occur in all of these, but may also only occur in some of these (due to their invisibility or irrelevance in some drawings or the 3D representation). Each 2D drawing specifies its own 2D drawing space, which requires a separate geometric description for each drawing. The 3D models share one Frame of Reference. Thus, each landmark needs only one 3D representation that then applies to all 3D models contained in one Instance. The Attribute Descriptions of the Attributes that geometrically define landmarks (in Table C.29.1.5-2 – C.29.1.5-4) contain complicated Conditions that express the following constraints:

Table C.29.1.5-1 GENERIC IMPLANT TEMPLATE PLANNING LANDMARKS MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
Planning Landmark Point Sequence (0068,6500) 3 Point landmarks for planning. One or more Items are permitted in this sequence.
>Include ‘Planning Landmark Point Macro’ Table C.29.1.5-2
>Planning Landmark ID (0068,6530) 1 Numeric ID of the planning landmark. Uniquely identifies a planning landmark within the SOP instance. The value shall start at 1, and increase monotonically by 1 for each Item.
>Planning Landmark Description (0068,6540) 3 Purpose or intended use of the landmark.
>Planning Landmark Identification Code Sequence (0068,6545) 2 Coded Description of the real-world point that is represented by the landmark. Zero or more Items shall be included in this sequence.
>>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7305
Planning Landmark Line Sequence (0068,6510) 3 Line landmarks for planning. One or more Items are permitted in this sequence.
>Include ‘Planning Landmark Line Macro’ Table C.29.1.5-3
>Planning Landmark ID (0068,6530) 1 Numeric ID of the planning landmark. Uniquely identifies the planning landmark within the SOP instance. The value shall start at 1, and increase monotonically by 1 for each Item.
>Planning Landmark Description (0068,6540) 3 Purpose or intended use of this landmark.
>Planning Landmark Identification Code Sequence (0068,6545) 2 Coded Description of the real-world line that is represented by this landmark. Zero or more Items shall be included in this sequence.
>>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7305
Planning Landmark Plane Sequence (0068,6520) 3 Plane landmarks for planning. One or more Items are permitted in this sequence.
>Include ‘Planning Landmark Plane Macro’ Table C.29.1.5-4
>Planning Landmark ID (0068,6530) 1 Numeric ID of the planning landmark. Uniquely identifies the planning landmark within the SOP instance. The value shall start at 1, and increase monotonically by 1 for each Item.
>Planning Landmark Description (0068,6540) 3 Purpose or intended use of the landmark.
>Planning Landmark Identification Code Sequence (0068,6545) 2 Coded Description of the real-world plane that is represented by this landmark. Zero or more Items shall be included in this sequence.
>>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7305

C.29.1.5.1 Planning Landmark Macros

Tables C.29.1.5-2 – C.29.1.5-4 contain macros for the definition of landmarks that can be used during planning to align an implant template with patient geometry.

All attributes within these Macros that contain 3D points or vectors are in x, y, z order. If multiple elements are encoded, the ordering is x 1 y 1 z, … , x n y n z n , The points are in the coordinate system identified by the Frame of Reference UID 0020,0052.

Table C.29.1.5-2 PLANNING LANDMARK POINT MACRO

Attribute Name Tag Type Attribute Description
2D Point Coordinates Sequence (0068,6550) 1C 2D coordinates of the point in the HPGL documents. One or more Items shall be included in this sequence. Required if 3D Point Coordinates (0068,6590) is not present and HPGL Document Sequence (0068,62C0) is present. May be present if 3D Point Coordinates (0068,6590) is present and HPGL Document Sequence (0068,62C0) is present.
>Referenced HPGL Document ID (0068,6440) 1 Value of the HPGL Document ID (0068,62D0) present in the HPGL Document Sequence (0068,62C0) that contains the 2D Drawing including the planning landmark. Shall be unique within the sequence.
>2D Point Coordinates (0068,6560) 1 Coordinates of the point in the HPGL document. Coordinates are measured in millimeters of the printing space. See C.29.1.2.1.1.
3D Point Coordinates (0068,6590) 1C 3D Coordinates of the point. Required if 2D Point Coordinates Sequence (0068,6550) is not present and Implant Template 3D Model Surface Number (0068,6350) is present. May be present if 2D Point Coordinates Sequence (0068,6550) is present and Implant Template 3D Model Surface Number (0068,6350) is present.

Table C.29.1.5-3 PLANNING LANDMARK LINE MACRO

Attribute Name Tag Type Attribute Description
2D Line Coordinates Sequence (0068,65A0) 1C 2D coordinates of the line in the HPGL documents. One or more Items shall be included in this sequence. Required if 3D Line Coordinates (0068,65D0) is not present and HPGL Document Sequence (0068,62C0) is present. May be present if 3D Line Coordinates (0068,65D0) is present and HPGL Document Sequence (0068,62C0) is present.
>Referenced HPGL Document ID (0068,6440) 1 Value of the HPGL Document ID (0068,62D0) present in the HPGL Document Sequence (0068,62C0) that contains the 2D Drawing including the planning landmark. Shall be unique within the sequence.
>2D Line Coordinates (0068,65B0) 1 Coordinates of the line in the HPGL document. Coordinates are measured in millimeters of the printing space. See C.29.1.2.1.1.
3D Line Coordinates (0068,65D0) 1C 3D Coordinates of the line. Required if 2D Line Coordinates Sequence (0068,65A0) is not present and Implant Template 3D Model Surface Number (0068,6350) is present. May be present, if 2D Line Coordinates Sequence (0068,65A0) is present and Implant Template 3D Model Surface Number (0068,6350) is present.

Table C.29.1.5-4 PLANNING LANDMARK PLANE MACRO

Attribute Name Tag Type Attribute Description
2D Plane Coordinates Sequence (0068,65E0) 1C 2D coordinates of the plane’s intersection with the HPGL documents. One or more Items shall be included in this sequence. Required if 3D Plane Origin (0068,6610) is not present and HPGL Document Sequence (0068,62C0) is present. May be present if 3D Plane Origin (0068,6610) is present and HPGL Document Sequence (0068,62C0) is present.
>Referenced HPGL Document ID (0068,6440) 1 Value of the HPGL Document ID (0068,62D0) present in the HPGL Document Sequence (0068,62C0) that contains the 2D Drawing including the planning landmark. Shall be unique within the sequence.
>2D Plane Intersection (0068,65F0) 1 2D Coordinates of the intersection of the plane with the projection plane. Coordinates are measured in Millimeters of the printing space. See C.29.1.2.1.1.
3D Plane Origin (0068,6610) 1C 3D Coordinates of the plane origin. Required if 2D Plane Coordinates Sequence (0068,65E0) is not present and Implant Template 3D Model Surface Number (0068,6350) is present. May be present if 2D Plane Coordinates Sequence (0068,65E0) is present and Implant Template 3D Model Surface Number (0068,6350) is present.
3D Plane Normal (0068,6620) 1C 3D Coordinates of the plane normal. Required if 3D Plane Origin (0068,6610) is present.

C.29.1.5.1.1 Planning Landmark Macros Attribute Descriptions

C.29.1.5.1.1.1 2D Coordinates Sequences

The 2D Point Coordinates Sequence (0068,6550) and 2D Line Coordinates Sequence (0068,65A0) contain the positions of point, line or plane landmarks in 2D templates. Each sequence item consists of a reference to one of the 2D templates and the point coordinates of the landmark with respect to that template. The Coordinates are with respect to the origin of the HPGL Document and are specified in Millimeters of the printing space.

C.29.2 Implant Assembly Template

This section describes the specific modules for the Implant Assembly Template IOD. This IOD references Instances of the Implant Template IOD.

C.29.2.1 Implant Assembly Template Module

Table C.29.2.1-1 defines the general Attributes of the Implant Assembly Template Module.

Table C.29.2-1 IMPLANT ASSEMBLY TEMPLATE MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
Effective DateTime (0068,6226) 1 Date and time from which on this Instance is valid.
Implant Assembly Template Name (0076,0001) 2 A name given to the assembly described in this instance.
Implant Assembly Template Issuer (0076,0003) 1 The person or organization who issued the assembly template.
Implant Assembly Template Version (0076,0006) 2 The version code of the Implant Assembly Template.
Replaced Implant Assembly Template Sequence (0076,0008) 1C Reference to the Implant Assembly Template that is replaced by this Instance. Only a single Item shall be included in this sequence. Required if the Instance replaces another Instance.
>Include ‘SOP Instance Reference Macro’ Table 10-11
Implant Assembly Template Type (0076,000A) 1 Indicates whether the Implant Assembly Template is derived from another Instance. Enumerated Values: ORIGINAL DERIVED
Original Implant Assembly Template Sequence (0076,000C) 1C Reference to the Implant Assembly Template Instance with Implant Assembly Template Type (0076,000A) ORIGINAL from which this Instance was ultimately derived. Only a single Item shall be included in this sequence. Required if Implant Assembly Template Type (0076,000A) is DERIVED.
>Include ‘SOP Instance Reference Macro’ Table 10-11
Derivation Implant Assembly Template Sequence (0076,000E) 1C Reference to the Implant Template Instance from which this Instance was directly derived. Only a single Item shall be included in this sequence. Required if Implant Assembly Template Type (0076,000A) is DERIVED.
>Include ‘SOP Instance Reference Macro’ Table 10-11
Implant Assembly Template Target Anatomy Sequence (0076,0010) 1 Identifies the anatomical region the implant assembly is to be implanted to. One or more Items shall be included in this sequence.
>Anatomic Region Sequence (0008,2218) 1 Sequence that identifies the anatomic region of interest in this Instance (i.e. external anatomy, surface anatomy, or general region of the body). Only a single Item shall be included in this sequence.
>>Include ‘Code Sequence Macro’ Table 8.8-1 Defined Context ID 7304 Implant Target Anatomy
Procedure Type Code Sequence (0076,0020) 1 Coded description of the procedure by which the assembly is implanted. One or more Items shall be included in this sequence.
>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7301.
Surgical Technique (0076,0030) 3 The surgical technique associated with this assembly template.
MIME Type of Encapsulated Document (0042,0012) 2 The type of the encapsulated document stream described using the MIME Media Type (see RFC 2046). Mime Type shall be “application/pdf”.
Encapsulated Document (0042,0011) 2 Encapsulated Document stream, containing a document encoded according to the MIME Type. PDF description of the surgical technique.
Component Types Sequence (0076,0032) 1 Sets of components of which the assembly is constructed. One or more Items shall be included in this sequence.
>Component Type Code Sequence (0076,0034) 1 Label assigned to that type of component. Only a single Item shall be included in this sequence.
>>Include ‘Code Sequence Macro’ Table 8.8-1 Baseline Context ID is 7307.
>Exclusive Component Type (0076,0036) 1 Indicates that only one component of this Component Type shall be used in an assembly. Defined Terms: YES NO
>Mandatory Component Type (0076,0038) 1 Indicates that at least one component of this Component Type has to be used in an assembly. Defined Terms: YES NO
>Component Sequence (0076,0040) 1 References to implant template components used in the assembly. One or more Items shall be included in this sequence.
>>Include ‘SOP Instance Reference Macro’ Table 10-11
>>Component ID (0076,0055) 1 Numeric ID of the Implant Template. Uniquely identifies the Implant Template within the SOP instance. The value shall start at 1, and increase monotonically by 1 for each Item.
Component Assembly Sequence (0076,0060) 3 Information about how to connect the implants from the component groups. One or more Items are permitted in this sequence. See C.29.2.1.1.1.1 for details.
>Component 1 Referenced ID (0076,0070) 1 Value of the Component ID (0076,0055) present in the Component Sequence (0076,0040) that contains the assembly implant components. The ID selects the first component of the connection.
>Component 1 Referenced Mating Feature Set ID (0076,0080) 1 Value of the Mating Feature Set ID (0068,63C0) present in the Mating Feature Set Sequence (0068,63B0) that contains the Mating Feature Sets. The ID selects the Mating Feature Set of the first component of the connection.
>Component 1 Referenced Mating Feature ID (0076,0090) 1 Value of the Mating Feature ID (0068,63F0) present in the Mating Feature Sequence (0068,63E0) that contains the Mating Features. The ID selects the Mating Feature of the Mating Feature Set of the first component of the connection.
>Component 2 Referenced ID (0076,00A0) 1 Value of the Component ID (0076,0055) present in the Component Sequence (0076,0040) that contains the assembly implant components. The ID selects the second component of the connection.
>Component 2 Referenced Mating Feature Set ID (0076,00B0) 1 Value of the Mating Feature Set ID (0068,63C0) present in the Mating Feature Set Sequence (0068,63B0) that contains the Mating Feature Sets. The ID selects the Mating Feature Set of the second component of the connection.
>Component 2 Referenced Mating Feature ID (0076,00C0) 1 Value of the Mating Feature ID (0068,63F0) present in the Mating Feature Sequence (0068,63E0) that contains the Mating Features. The ID selects the Mating Feature of the Mating Feature Set of the second component of the connection.

C.29.2.1.1 Implant Assembly Template Module Attribute Description

C.29.2.1.1.1 Component Assembly Sequence

This Sequence defines a table that establishes relations between Mating Features in Implant Templates. This table contains possible connections for the surgical technique described in an instance.

C.29.3 Implant Template Group Module

This section describes the specific modules for the Implant Template Group IOD.

C.29.3.1 Implant Template Group Module

Table C.29.3.1-1 contains the Attributes of the Implant Template Group Module.

Table C.29.3-1 IMPLANT TEMPLATE GROUP MODULE ATTRIBUTES

Attribute Name Tag Type Attribute Description
Effective DateTime (0068,6226) 1 Date and time from which on this Instance is valid.
Implant Template Group Name (0078,0000) 1 Name of this group
Implant Template Group Description (0078,0010) 3 Purpose or intent of this group.
Implant Template Group Issuer (0078,0020) 1 Person or Organization that issued this group.
Implant Template Group Version (0078,0024) 2 The version code of the Implant Template Group.
Replaced Implant Template Group Sequence (0078,0026) 1C Reference to the Implant Template Group that is replaced by this Instance. Only a single Item shall be included in this sequence. Required if this Instance replaces another Instance.
>Include ‘SOP Instance Reference Macro’ Table 10-11
Implant Template Group Target Anatomy Sequence (0078,0028) 3 Identifies the anatomical region the implant is to be implanted to. One or more Items are permitted in this sequence.
>Anatomic Region Sequence (0008,2218) 1 Sequence that identifies the anatomic region of interest in this Instance (i.e. external anatomy, surface anatomy, or general region of the body). Only a single Item shall be included in this sequence.
>>Include ‘Code Sequence Macro’ Table 8.8-1 Defined Context ID 7304 Implant Target Anatomy
Implant Template Group Members Sequence (0078,002A) 1 Contains references to all Implant Template SOP instances that are part of this group. One or more Items shall be included in this sequence.
>Include ‘SOP Instance Reference Macro’ Table 10-11
>Implant Template Group Member ID (0078,002E) 1 Numeric ID of the Implant Template. Uniquely identifies the Implant Template within the Implant Template Group. The value shall start at 1, and increase monotonically by 1 for each Item.
>3D Implant Template Group Member Matching Point (0078,0050) 1C 3D inter-component Matching Point. May be present if Number of Surfaces (0066,0001) is present in the Instance referenced in the Implant Template Group Members Sequence Item. See C.29.3.1.1.1
>3D Implant Template Group Member Matching Axes (0078,0060) 1C Direction cosines of the Matching Point. Required if 3D Implant Template Group Matching Point (0078,0050) is present.
> Implant Template Group Member Matching 2D Coordinates Sequence (0078,0070) 1C One or more Items shall be included in this sequence. May be present if HPGL Document Sequence (0068,62C0) is present in the Instance referenced in the Implant Template Group Members Sequence Item. See C.29.3.1.1.1
>>Referenced HPGL Document ID (0068,6440) 1 Value of the HPGL Document ID (0068,62D0) present in the HPGL Document Sequence (0068,62C0) of the Instance that is referenced in the Implant Template Group Members Sequence Item. Shall be unique within the sequence.
>>2D Implant Template Group Member Matching Point (0078,0090) 1 2D inter-component Matching Point. See C.29.3.1.1.1.
>>2D Implant Template Group Member Matching Axes (0078,00A0) 1 Direction cosines of the Matching Point. See C.29.3.1.1.1.
Implant Template Group Variation Dimension Sequence (0078,00B0) 1 List of all Variation Dimensions that are covered by this group. One or more Items shall be included in this sequence. See C.29.3.1.1.2.
>Implant Template Group Variation Dimension Name (0078,00B2) 1 Descriptive name of the variation dimension.
>Implant Template Group Variation Dimension Rank Sequence (0078,00B4) 1 Order in which the implant group members are sorted according to this dimension. One or more Items shall be included in this sequence.
>> Referenced Implant Template Group Member ID (0078,00B6) 1 Value of the Implant Template Group Member ID (0078,002E) present in the Implant Template Group Member Sequence (0078,002A) that contains the Implant Template Group Member Items. Shall be unique within the sequence.
>>Implant Template Group Variation Dimension Rank (0078,00B8) 1 The rank of this Implant Template in the Variation Dimension. In one Implant Template Group Variation Dimension Rank Sequence there may be more than one Implant Templates with the same rank.

C.29.3.1.1 Implant Template Group Module Attribute Description

C.29.3.1.1.1 Implant Template Group Member Matching Coordinates

Template Groups are used to facilitate browsing through a set of similar implants. The Template Group Member Matching Coordinates is a coordinate system in the Frame of Reference of every member of the group which is used to place and orient the members of the group in a similar way: When a user or a system positioned one member of the group within the Frame of Reference of the patient, then all other members of the family are placed and oriented so that their Template Group Member Matching Coordinates coincide.

The matching coordinates are applied similar to the mating features during implant template mating. An example is found in part 17, Figure C.29.3.1.1.1-1.

[pic]

Figure C.29.3.1.1.1-1 Implant Template Groups Example.

C.29.3.1.1.2 Implant Template Groups

Implant templates in the group can be ordered according to several orthogonal dimensions, e.g., width and length. This is intended to facilitate scrolling through the implant template repository by offering references to the next bigger and smaller templates according to multiple criteria. Figure C.29.3.1.1.2-1 shows how the Variation Dimensions may be used for plates that differ in two dimensions: length and number of holes.

[pic]

Number of holes
Rank 1 2 3 4
Length 1 [pic] ID1 [pic] ID2
2 [pic] ID3 [pic] ID4 [pic] ID5
3 [pic] ID6 [pic] ID7 [pic] ID8 [pic] ID9

Figure C.29.3.1.1.2 Implant Template Group for 2 Dimensions Example