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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
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
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