One-piece sensor for bioelectrode and processes for production

A sensor, electrode technology, applied in the field of medical devices, can solve problems such as limiting productivity

Inactive Publication Date: 2018-08-31
3M INNOVATIVE PROPERTIES CO
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  • Summary
  • Abstract
  • Description
  • Claims
  • Application Information

AI Technical Summary

Problems solved by technology

The method of snapping the eyelet and stud together can be a problematic and also a productivity limiting step in the manufacturing process

Method used

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  • One-piece sensor for bioelectrode and processes for production
  • One-piece sensor for bioelectrode and processes for production
  • One-piece sensor for bioelectrode and processes for production

Examples

Experimental program
Comparison scheme
Effect test

Embodiment 1

[0051] Example 1: Through Membrane Injection Molded Sensor

[0052] A small laboratory scale mold was fabricated with a design to produce an integral sensor shaped such that it would connect to current industry standard leads. Implement several variations on the currently used shapes to produce such as Figure 5 Sensor 400 is depicted. First, using an appropriately designed syringe (from Tulip TM Medical Products Company (Tulip TMMedical Products) form bulb 410 (ie, the larger diameter segment at the end of post 405). This enables the entire sensor 400 to be molded in one step, with the parting line perpendicular to the post axis. This variation facilitates molding through the membrane 401 as opposed to current injection molded sensors which have a parting line parallel to the post axis and do not mold the sensor through the membrane. An additional variation is to mold the membrane retention feature 407 directly into the sensor 400 . Membrane retention feature 407 perm...

Embodiment 2

[0055] Example 2: Performance Testing of Sensors Injected Through Membrane

[0056] Web injection molded sensors produced according to Example 1 were tested to assess the ability of the method to produce acceptable electrodes. 240 samples were produced with different backing materials and injection arrangements. The contact surface of each sensor was coated with silver / silver chloride screen-printable ink (DuPont grade 5880) and cured according to the manufacturer's instructions. Table 1 shows the data collected for all sensors molded through PET and polypropylene webs. Table 1 shows the resistance of the sensor. The value of the resistance was measured by clamping a standard lead connector to the end of the post and placing the lead to measure in wire contact on the contact face of the sensor. The columns labeled Area Resistance are the resistance values ​​at points that touch the surface but are not in contact with the gate location. When the leads are placed in contac...

Embodiment 3

[0063] Embodiment 3: Preparation and performance test of ECG electrode

[0064] Multiple sensors were molded through the polypropylene web for actual electrode testing. The sensor was coated with a silver / silver chloride screen printable ink (grade 5880) commercially available from DuPont. A polypropylene web with the sensor molded into it was bonded to a pre-punched foam backing centered on the gel well. A UV-curable electrolyte gel was added to the foam cavity on top of the web-injected sensor and cured. The electrodes were placed on paper liners and aged in a moisture-proof bag in an oven at 49°C for 2 days. The electrodes were taken out of the oven and out of the pouch, and placed in ambient laboratory conditions. Ten electrodes were tested every other week to determine electrode "out of bag" performance.

[0065] The primary measure of how well the sensor / web seal functions is the electrical performance of the electrodes when left "out of bag (OOB)" in an unsealed b...

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PUM

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Abstract

A process for producing a sensor (107) for a biomedical electrode (170) (e.g. an ECG electrode) involves injection molding an electrically conductive resin through a film (106) of a backing material to form the sensor directly in the backing material and coating the contact face of the sensor with a non-polarizable conductive material (109) (e.g. silver-containing material). Additional steps of applying an electrolyte (132) over the non-polarizable conductive material coated on the contact face and applying a liner (141) over the electrolyte results in the biomedical electrode. Biomedical electrodes produced thereby have the sensor secured in a film of the backing material with a contact face (103) of the sensor disposed on a first side of the film and a post (105) of the sensor protrudingfrom a second side of the film opposite the first side. The process permits production of one-piece sensors for bioelectrodes in a continuous fashion without the need for studs to retain sensors in afilm of the backing material.

Description

[0001] Cross References to Related Applications [0002] This application claims priority to US Provisional Patent Application No. 62 / 270,649, filed December 22, 2015, the disclosure of which is incorporated herein by reference in its entirety. [0003] This patent application relates to medical devices, in particular to sensors for medical electrodes and methods of producing sensors and medical electrodes. Background technique [0004] Electrocardiogram (ECG) electrodes typically rely on silver-coated metal rings to operate. Metal loops typically pass through the strap or backing to physically mate with metal or plastic studs or snaps. This interaction holds the eyelet to the adhesive portion of the web and ensures a good moisture seal through the electrode backing. Eyelets are usually manufactured by injection molding ABS resin to produce discrete parts and coating the entire part with silver. Using parts produced in this way requires manipulation and assembly of the dis...

Claims

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Application Information

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Patent Type & Authority Applications(China)
IPC IPC(8): B29C45/14A61B5/0408
CPCB29L2031/753B29K2995/0005A61B5/0006B29C45/14344B29C45/0053B29C45/14016A61B2562/0209A61B2562/125B29C2045/0079B29K2105/12A61B5/25A61B5/259A61B5/266A61B5/268A61B5/265B29C45/14336B29L2031/752
Inventor 卡梅龙·E·德里约翰·P·特里普诺普洛斯
Owner 3M INNOVATIVE PROPERTIES CO
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