Color coded header bore identification using multiple images and lens arrangement

Patent metadata

Field	Value
Publication number	US-9724527-B2
Application number	US-201414498111-A
Country	US
Kind code	B2
Filing date	Sep 26, 2014
Priority date	Sep 27, 2013
Publication date	Aug 8, 2017
Grant date	Aug 8, 2017

Abstract

An implantable pulse generator includes a device housing containing pulse generator circuitry and a header connected to the device housing. The header includes a core assembly defining first and second lead bore cavities sized for receiving terminal pins of leads, first and second labels, and an outer layer. The first label is printed onto a surface of the core assembly proximate the first lead bore cavity and includes a first color. The second label is printed onto the surface of the core assembly proximate the second lead bore cavity and includes a second color different from the first color. The outer layer is overmolded over the core assembly so as to encapsulate the first and second labels and to allow access to the first and second lead bore cavities.

First claim

We claim:

1. An implantable pulse generator comprising:
a device housing containing pulse generator circuitry; and
a header connected to the device housing, the header comprising:
a core assembly defining first and second lead bore cavities sized for receiving terminal pins of leads;
a first label formed from a first ink having a first pigment printed onto and in contact with a surface of the core assembly proximate the first lead bore cavity, wherein the first label comprises a first color;
a second label formed from a second ink having a second pigment, different from the first pigment, printed onto and in contact with the surface of the core assembly proximate the second lead bore cavity, wherein the second label comprises a second color different from the first color;
a lens positioned proximate to at least one of the first label and the second label, wherein the at least one of the first label and the second label proximate to the lens includes multiple images such that different appearances are produced when viewed through the lens at different angles; and
an outer layer overmolded over the core assembly so as to encapsulate and hermetically seal at least the first and second labels from an external environment and to allow access to the first and second lead bore cavities.

2. The implantable pulse generator of claim 1 , wherein the core assembly comprises an engineered thermoplastic polyurethane and the outer layer comprises an epoxy resin that bonds to the core assembly so as to isolate the first and second labels from an exterior of the header.

3. The implantable pulse generator of claim 1 , wherein the lens is a lenticular lens.

4. The implantable pulse generator of claim 1 , wherein the outer layer is transparent.

5. The implantable pulse generator of claim 1 , and further comprising:
a first lead having a first terminal pin and a third label comprising the first color, wherein the first terminal pin is positioned in the first lead bore cavity; and
a second lead having a second terminal pin and a fourth label comprising the second color, wherein the second terminal pin is positioned in the second lead bore cavity.

6. The implantable pulse generator of claim I, wherein the first label comprises radiopaque ink patterned to define a first indicia that is viewable via radiology imaging systems and wherein the second label comprises radiopaque ink patterned to define a second indicia that is viewable via radiology imaging systems and that is different from the first indicia.

7. The implantable pulse generator of claim 1 . wherein the first label comprises ink patterned as a first indicia that is viewable in the visible light spectrum and wherein the second label comprises ink patterned as a second indicia that is viewable in the visible light spectrum and that is different from the first indicia.

8. The implantable pulse generator of claim 1 , wherein the first lead bore cavity is a defibrillation lead bore cavity configured for connecting to a defibrillation lead terminal pin, the second lead bore cavity is a pacing lead bore cavity configured for connecting to a pacing lead terminal pin, the core further defines a low-voltage lead bore cavity configured for connecting to a low-voltage lead terminal pin, the first label is a red-pigmented label positioned proximate the defibrillation lead bore cavity, the second label is a white-pigmented label positioned proximate the pacing lead bore cavity, and further comprising a green-pigmented label printed onto the surface of the core assembly proximate the low-voltage lead bore cavity.

9. The implantable pulse generator of claim 8 , wherein the red-pigmented label comprises a red-pigmented portion and a first white-pigmented portion and wherein the green-pigmented label comprises a green-pigmented portion and a second white pigmented portion.

10. The implantable pulse generator of claim 8 , wherein the red-pigmented label includes no green-pigmented portion and wherein the green-pigmented label contains no red-pigmented portion.

11. The implantable pulse generator of claim 1 , wherein the first label includes a first machine-readable indicia and where the second label includes a second machine-readable indicia different from the first machine-readable indicia.

12. A method of labeling a header of an implantable pulse generator, the method comprising:
printing a first label including first multiple images onto a surface of a core assembly proximate a first lead bore cavity;
printing a second label including second multiple images different from the first multiple images onto the surface of the core assembly proximate a second lead bore cavity;
positioning a first lens proximate to the first label such that first different images of the first multiple images are visible when viewed through the lens at different angles;
positioning a second lens proximate to the second label such that second different images of the second multiple images are visible when viewed through the lens at different angles; and
overmolding an outer layer over the core assembly so as to encapsulate and to hermetically seal at least the first and second labels from an external environment and to allow access to the first and second lead bore cavities.

13. The method of claim 12 , and further comprising:
patterning a first set of indicia onto the first label and a second set of indici a different from the first set of indicia onto the second label.

14. An implantable pulse generator comprising:
a device housing containing pulse generator circuitry;
a header connected to the device housing, the header defining first and second lead bore cavities sized for receiving terminal pins of leads;
a first label positioned on a first portion of the header proximate the first lead bore cavity, wherein the first label comprises a first colored pigment and a first indicia;
a second label positioned on a second portion of the header proximate the second lead bore cavity, wherein the second label comprises a second colored pigment different from the first colored pigment and a second indicia different from the first indicia:
a first lens positioned proximate to the first label so as to magnify the first label such that when the first label is viewed through the first lens from a first angle only the first colored pigment is visible through the lens and when the first label is viewed through the first lens from a second angle only the first indicia is visible through the first lens;
a second lens positioned proximate to the second label so as to magnify the second label such that when the second label is viewed through the second lens from a third angle only the second colored pigment is visible through the lens and when the second label is viewed through the second lens from a fourth angle only the second indicia is visible through the second lens; and
an outer layer encapsulating the first label, the second label and the lens and allowing access to the first and second lead bore cavities.

15. The implantable pulse generator of claim 14 , wherein the first lead bore cavity is a defibrillation lead bore cavity configured for connecting to a defibrillation lead terminal pin, the second lead bore cavity is a pacing lead bore cavity configured for connecting to a pacing lead terminal pin, the header further defines a low-voltage lead bore cavity configured for connecting to a low-voltage lead terminal pin, the first label is a red-pigmented label positioned proximate the defibrillation lead bore cavity, the second label is a white-pigmented label positioned proximate the pacing lead bore cavity, and fu

Assignees

• Cardiac Pacemakers Inc

Inventors

• Edgell John M
• Maile Keith R
• Linder William J
• Foster Arthur J
• Swackhamer Bryan J
• Kane Michael J
• Reardon John

Classifications

• A61N1/3752

  Details of casing-lead connections · CPC title

• G09F3/10

  by an adhesive layer · CPC title

• A61N1/3968 Primary

  Constructional arrangements, e.g. casings (A61N1/375 takes precedence) · CPC title

• B41F17/00

  Printing apparatus or machines of special types or for particular purposes, not otherwise provided for · CPC title

• A61N1/39622

  Pacing therapy · CPC title