Obesity Treatment using Neurostimulation - Technology Evolution
Transcript of Obesity Treatment using Neurostimulation - Technology Evolution
Obesity Treatment usingNeurostimulation
Technology Evolution& Patent Landscape
Industry Insight
Deeper Insight. Better Outcomes
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$ m
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Obesity Pharmaceutical Sales ($millions)
Bariatric Surgical Device Sales ($millions)
The key players in this field include:
• Medtronics Inc
• Cyberonics Inc
• Advanced Neuromodulation Systems (now a part of
St. Jude Medical)
• Biocontrol Medical Ltd
• Leptos Biomedical Inc
• Enteromedics
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The concept of neurostimulation to affect functioning of
organs has been extensively used in medical
practice to treat various disorders such as Parkinson's
disease, multiple sclerosis, epilepsy, chronic pain, etc.
The use of neurostimulation for obesity treatment was
first suggested in the early 1990s. Ever since, there has
been a steady growth in Intellectual Property
investments in this domain, especially in the US (Figure2).
The incidence of obesity has more than doubled in the
last 25 years, now affecting around 33% of adult
population in the United States according to the
Centers for Disease Control & Prevention (CDC). The
World Health Organization (WHO) predicts that obesity
may soon replace more traditional public health
concerns such as under-nutrition and infectious
diseases, as the most significant cause of poor health.
The healthcare cost of obesity in the United States (US)
is estimated to be $147 billion annually (equivalent to
9.1% of total medical spending)[1].
The principal treatments currently available for obesity
include diet modification and exercise, pharmaceutical
therapies and surgical procedures like gastric bypass
and vertical banded gastroplasty. Besides these, the
industry has witnessed a flurry of activities around the
idea of using neurostimulation for treatment of obesity.
The market size for treatments related to obesity is also
expected to grow significantly over the next decade
(Figure 1).
[1] “Annual Medical Spending Attributable To Obesity: Payer-And
Service-Specific Estimates” by Eric A. Finkelstein, Justin G.
Trogdon, Joel W. Cohen and William Dietz.
Health Affairs, 28, no. 5 (2009):w822-w831
[2] Medmarket Diligence Report #S825 – “Worldwide Market
for the Clinical Management of Obesity, 2007”
Introduction Neurostimulation for Obesity Treatment
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Figure 1: Bariatric Surgical Devices and Pharmaceuticals in Obesity, Worldwide Sales 2006-2015 [2]
Figure 2: Patent filing trend in the US
Neurostimulation for Obesity Treatment
825 281
Stimulation methods
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StimulatingLocation
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MonitoringMethod
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Other medicalmethods
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Stimulator peripherals
30Signal Modulator
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CommunicationFacilitator
106Control System
116Testing & monitoringsystem
9Miscellaneous
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Neurostimulators
117Vagus Nerve
5Splanchnic Nerve
40Deep Brain
1Spinal Cord
87Autonomous Nerve
187Other Nerves
7Miscellaneous
Level 1 Level 2 Level 3
Intellectual Property (IP) investments and the patents
granted in this domain can be classified into three
broad categories (Figure 3) –
• Neurostimulators
• Stimulation methods
• Stimulator peripherals
Identifying anatomical locations for stimulation has
been the most prominent patenting field. The industry
has also seen significant IP investments, especially in
patents related to stimulators for autonomous nerve or
more specifically Vagus nerve. However, not many
patents are present in the field of neurostimulators
specific for Splanchnic nerves.
Most of the patents related to neurostimulators belong
to Advanced Neurostimulation Systems and Biocontrol
Medical. Cyberonics dominates the field of stimulation
methods while Medtronics has made considerable
investments in stimulator peripherals.
Stimulation of Vagus nerve has received extensive
focus from these industry leaders resulting in significant
patenting activity in this domain.
This article presents a detailed analysis of the evolution
of Vagus nerve stimulation technology. Further, it
provides insight on related technology areas that offer
scope for innovation and an investment opportunity for
IP protection.
Intellectual Propertyin Neurostimulation
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Figure 3: Patent Classification
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Communication Facilitation & Other Peripherals
Use of Control Unit
Stimulation Signal Patterns
Screening and Monitoring Methods
New Stimulation Effects
Vagus nerve stimulation for obesity treatment
Gastric Band with Electrodes
Neurostimulator Designs
Transcutaneous Neurostimulation
New Stimulation Locations
1991 1997 1998 1999 2000 2001 2002 2003 2004 2005 2006 2007 2008 2009
Biocontrol Medical Ltd.
Assignees
Cyberonics
Enteromedics
Medtronics
Neuro & Cardiac Technologies
Others
The idea of stimulating the Vagus nerve to treat obesity
was conceived and patented in the year 1991 by
Cyberonics. Thereafter, many players have adapted
and actively entered the field of Vagus nerve
stimulation (Figure 4).
The technology evolution tree shows the entry and
activity of key players in the domain in the last 20 years.
It can be observed that Cyberonics entered the field
first, followed by Neuro & Cardiac Technologies.
Biocontrol Medical Method. entered the domain in the
year 2001. Biocontrol was started by an entrepreneur
named Yossi Gross who also founded
companies like DuoCure, Beta Stim which work in the
domain of Vagus nerve stimulation.
The players in the field of Vagus nerve stimulation have
focused their research resources on few specific areas.
For instance, Medtronic entered this field in 2002, and
developed its footprint in the area of ‘Screening &
Monitoring Methods’ for Vagus nerve stimulation.
Similarly, Enteromedics and Biocontrol Medical have
many patents on ‘Use of Control Unit’, while Neuro &
Cardiac Technologies has focused on development of
‘Communication facilitation & other peripherals’.
There are technology areas related to Vagus nerve
stimulation that have not witnessed significant
patenting activity till date. These areas include
‘Stimulation signal patterns’, ‘Neurostimulators designs’
along with ‘Gastric bands with electrodes’, and
‘Transcutaneous neurostimulation’.
There are significant number of patents related to
‘Screening & Monitoring Methods’, ‘New Stimulation
locations’ and ‘Communication facilitation & other
peripherals’.
In technology areas that have higher number of
patents, claim-wise mapping of the patents may help in
understanding the protection provided by them. Apart
from this, claim-wise mapping also throws some light on
the possibility of overlap among the patents in question.
To illustrate this, a detailed claim-wise overlap analysis
of patents in ‘Screening & Monitoring methods’ is
explained in the next section.
Screening & Monitoring Methods: Claim-wise MapA significant number of patents that deal with Vagus
nerve stimulation discuss ‘Screening & Monitoring
methods’. Many companies have ventured into this
technology area and filed for patents with Medtronic
and Cyberonics leading the pack. Figure 5 shows the
claim-wise overlap analysis of the patents in this area.
The analysis helps in identifying the key players and their
focus areas. Medtronic is the major assignee in this
sub-domain with 5 patent applications. These patents
are related to modulating the stimulating signal based
on the feedback received from the patient. Cyberonics
also has a significant presence in this sub-domain, with
4 patent applications. The applications relate to giving
stimuli prior to the induction of therapeutic stimulating
signal.
The claim wise overlap analysis further helps in
identifying the features that are extensively covered by
the existing patents and applications. For example,
features like ‘determining stimulating parameters’,
‘modulating the signal based on feedback’ and
‘stimulating after feedback’ have been covered in
various patents and applications. On the other hand,
features like ‘detecting condition of the nerve’,
‘redelivery of signals after temporary signal halting’ and
‘using imaging techniques for monitoring’ are present in
just one patent / application each.
Vagus Nerve Stimulation:Evolution of Technology
Figure 4: Technology Evolution Tree4 5
The number inside the circle denotes the number of US patents / applications
The concept of neurostimulation for treatment of
obesity has gained momentum in the past decade.
There has been substantial patenting activity related to
Vagus nerve stimulation. However, there are ample
opportunities in the field of Splanchnic nerve stimulation
for the new players who wish to venture into obesity
treatment using neurostimulation.
For those interested in Vagus nerve stimulation, there is
scope for innovation around design of neurostimulators
and understanding the signal patterns and their
application. On the other hand, screening and
monitoring methods used in Vagus nerve stimulation
have been extensively patented.
For the players that wish to develop products related to
screening and monitoring methods used in Vagus nerve
stimulation, it would be beneficial to perform a detailed
FTO, especially if they are planning to include features
like modulating the signal based on feedback and
stimulating after feedback. On the other hand,
innovation and product development around
detecting condition of the nerve, redelivery of signals
after temporary signal halting and using imaging
techniques for monitoring can be less risky.
Conclusion
Priority Date Feb-02 Oct-02 Oct-02 Oct-02 Mar-03 Oct-03 Jul-04 Sep-04 Oct-05 Oct-05 Nov-05 Jan-06 Jan-06 Jul-06 May-07
Company JeffreyHargrove
S.E.Kara-shurov
Duocure,Inc Electrocore Electrocore Pacesetter,
Inc.Medtronic, Inc. Medtronic, Inc. Cyberonics, Inc. Cyberonics, Inc.
Patent Applications
Determining stimulating parameters
Receiving feedback forthe stimulation
Detecting neurological events
Detecting physiological parameters
Detecting condition of the nerve
Detecting biochemicalsof nerve tissues
Modulating the signal basedon the feedback
Redelivery of signals aftertemporary signal halting
Prediction of stimulation resultusing statistical data
Blanking/blocking the signal
Using imaging technique formonitoring
Stimulating after feedback
Monitoring plurality of nerves
Simulataneous stimualtion of pluralityof electrodes with different signals
Sending non-therapeutic stimulusbefore the therapeutic stimulatingsignal
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Figure 4: Claim-wise Mapping
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