1

Miniature Cylindrical Medical Batteries for Small Devices

December 2018

Samuel De-Leon

shmuel@sdle.co.il

www.sdle.co.il

Medical Battery TypesPortable medical batteries

• Infusion Pumps, Oxygen Concentrators

• Patient Monitoring, Handheld Surgical Tools

• Powered Surgical Instruments

• Portable X-ray & Imaging Solutions

• Ultrasound Devices, Ventilators

Implantable medical batteries• Pacemakers, ICD’s, Neuro stimulators

• Drug pumps, Loop recorders

• Cochlear implants, LVAD’s

On body/patch devices• Insulin pumps

• Drug injectors

Microelectronic Pills• Cancer detectors, Gastro cameras

• Medical sensors

Medical Battery Challenges• Performance – Ability to provide energy and power

• Hygiene - Sustainability in warm and humid environment

• Safety

• Reliability - 10 years or more

• Certifications – Many kind of testing

• Cost – Affordable

Medical Batteries - Different Requirements

Implantable Battery Electronic Pill Battery External Battery

Safety Safety Safety

Performance Performance Performance

Hermetically Sealed Hermetically Sealed - No Hermetically Sealed - No

“Zero Volt” for Li-Ion “Zero Volt” for Li-Ion - No “Zero Volt” for Li-Ion - No

Design for a constant 37

Deg C.

Design for a constant 37

Deg C.

Design for a constant 37

Deg C - No

Proven Reliability Proven Reliability Proven Reliability - No

Proven Quality Proven Quality Proven Quality - No

Medical technical support

in a case of malfunction

Medical technical support

in a case of malfunction

Medical technical support -

No

Special Cells Small Consumer Cells Standard Consumer Cells

Medical Device Lithium Battery Certification

UN Transportation testing UN/DOT 38.3 - Mandatory

UL-1642: Lithium Batteries - Focus on single-cells - Used for evaluation

of Lithium-Metal (Primary) or of Lithium-Ion (Rechargeable)

UL-2054: Household and Commercial Batteries - Focus on Portable

Batteries - Typically Battery Packs - References UL 1642 for Lithium

Cells

IEC-60086 - Primary Batteries (Non-rechargeable) - Covers Performance

and Safety - IEC-60086-4 For Lithium (Primary) battery safety

IEC-62133 - Secondary Batteries (Rechargeable) - Focus on Lithium-ion

Batteries - First Edition, October 2002 - Second Edition released:

December 2012

6

FDA – No Battery Approval Guidelines for Medical Batteries

“In terms of guidance unfortunately we don’t have a

published guidance yet. However we have recognized 3

battery related standards that deal with battery safety (IEC

62133 and UL 2054 and UL 1642) and are good indicators

of the types of tests we expect to see to demonstrate

medical battery safety. Thus, if a medical device battery

conforms to either 62133 or 2054 then the test report can

provide us with the needed assurance for battery safety.

As for performance, this will probably require additional

knowledge of the host device that utilizes the battery.

Microelectronic Pill Applications

• Ingestible Drug Delivery System

• Camera pill – Colon Probing

(Endocapsule)

• Colon Cancer

8

FDA – Approved Wireless Capsule Systems

Silver Oxide Cells as a Mid Term Solution

• 1.5V cells

• Battery made from 2-3 button cells (SR44…)

• Operating time 12- 40 hours

• Current consumption of constant uA & mA pulses

• Low cost (consumer cells)

• No transportation regulations

• FDA approval

• Some cell types has High energy and power

• Proven success stories (Given Imaging, Drug injectors..)

10

LG Li-Ion Pin Cells

11

Panasonic Small Pin Cylindrical Li-Ion Hard Case cells

12

13

GP Li-Ion Miniature Cells

http://www.gpbmindustry.com/uploads/downloads/6.pdf

Miniature Cylindrical Lithium Cells for Microelectronic Pills

• Conventional hard case cells

• Max size of 11.6mm diameter over 10.8 length – But

smaller diameter is preferred

• Primary cells – High energy but low power

• Rechargeable cells – Low energy but high power

• Very few on the shelf solutions

• Costly custom made solutions

Rechargeable cellsPrimary cells

GP

GP0820L07

D=8.5mm

L=20mm

Panasonic

CG-320

D=3.5mm

L=20mm

Quallion

QL0003i

D=2.9mm

L=13mm

EP

500uAH

D=2.37mm

L=6.73mm

CR927Li/MnO2

CR621Li/MnO2

CR1130Li/MnO2

CR1025 Li/MnO2

Silver

Oxide

357

24423413160512707662570529Wh/L

489506131012116.39.4147146W/L

Current

solutions

15

Button Li-Ion cell for Implantable Medical Device

Developed in Switzerland by Wyon – Contact us for more details

16

Silver Oxide Batteries

Smallest Micro Li-Ion cell for Implantable Eye Device

Developed in Switzerland by Wyon – Contact us for more details

17

Eagle Picher Li-Ion Implantable Miniature cells

Quallion Implantable cells include:

- Prismatic Li-Ion cells in a range of 200mah to 2A

- Cylindrical Li-Ion cells in a range of up t 20mAh

http://www.directindustry.com/prod/enersys/product-19888-1509293.html

Quallion Li-Ion Implantable Miniature Cylindrical cells

19

Cylindrical Rechargeable Lithium Pouch cells

http://www.evebattery.com/en2/products.aspx?category=80

20

Availability on the Shelf

21

22 http://www.bkbattery.com/en/product2.aspx?CateId=127

23

http://www.prologium.com/

Cylindrical Solid Electrolyte Rechargeable Lithium Cells

Cylindrical Li-Po cells Advantages for Microelectronic

Pills• High power than any primary cell solution

• Rechargeable cell – Can be charge wirelessly while in

operation

• Low cost custom made solution on small sizes

• Polymer electrolyte – No leaks

• Automatic production line - Quality

Rechargeable cellsPrimary cells

EVE

75500

D=7.7mm

L=52mm

GP

GP0820L07

D=8.5mm

L=20mm

Panasonic

CG-320

D=3.5mm

L=20mm

Quallion

QL0003i

D=2.9mm

L=13mm

EP

500uAH

D=2.37mm

L=6.73mm

CR1025

Li/MnO2

Silver

Oxide

357

29024423413160570529Wh/L

58048950613101217146W/L

Wireless Charging

We cant afforded any Safety Event

Spontaneous explosion of implantable cardioverter-defibrillator

http://www.medtees.com/content/EuropaceCaseReport.pdf

27 http://www.medicalbatteryconference.com/

Shmuel De-Leon Shmuel De-Leon Energy Ltd

www.sdle.co.ilshmuel@sdle.co.il

Information for presentation obtained by:

1. Public web sources.

2. Shmuel De-Leon Battery/Energy Sources DataBase ® (Includes 29000 cell PDF data sheets ) http://www.sdle.co.il/Default.asp?sType=0&PageId=45580