THE FACT OF THE MATTER



The root cause of the technical difficulties of colon intubation can be found in the mechanical design of the primary

instrument, COLONOSCOPE, that governs: (1) insertion operation of instrument and (2) angulation control of bending

section of the instrument that is configured, primarily, to aid insertion operation and secondarily, to enable clinical

(i.e., screening, diagnosis and therapy) operation. By design, the insertion operation can be powered or driven only by

a "push" action imparted on the shaft of instrument by the surgeon that often results in uncontrollably convoluted

layout of the inserted portion of the shaft, referred to as "looping", that must be unraveled often repeatedly employing

various technically challenging maneuvers. Occurrence of looping is not predictable and can be recognized only after

the fact. Incidentally, the design of bending section also imposes severe constraints on the clinical operation.


Any hand held device or robotic assisted system products aiming to improve the art of colonoscopy, particularly, to

ameliorate the technical difficulties of colon intubation should directly address the root cause that the hopelessly

outdated, inapt design of the primary instrument of colonoscopy, COLONOSCOPE, is but not just the symptom that

the technical difficulties of colon intubation is.





TECHNOLOGICAL VISION



1. Development of hand-held and robotic assisted colon intubation system for screening colonoscopy and in-hospital

supplementary colon preparation for screening colonoscopy performed by a trained technician (backward compatible

with colonoscope instrument with conventional shaft and bending section technologies)


2. Development of a specialty, multipurpose endoscope, disposable and reposable, for screening colonoscopy for use

in: (1) supplementary colon preparation (irrigation/ suction functions) (2) screening (omnidirectional vision function)

and (3) therapeutic intervention (articulating or steerable instruments) adapted for use with the robotic assisted colon

intubation system in partnership with a GI endoscope manufacturer


3. Development of: (1) an omnidirectional vision instrument with control system and (2) articulating or steerable

instruments with control system adapted for use with the specialty, multipurpose endoscope for screening

colonoscopy in partnership with a GI endoscope/robotic assisted surgery system manufacturer


4. Development of a specialty, conventional colonoscope with a robotic assisted angulation control adapted for use

with the robotic assisted colon intubation system in partnership with a GI endoscope manufacturer for precision

polypectomy and ESD with conventional tools, e.g., snares and forceps.


5. Development of robotic assisted endoluminal (colon) surgery system based on the robotic assisted colon intubation

and stabilization system platform in partnership with a GI endoscope/robotic assisted surgery system manufacturer



- Surgery hardware (instrument launch platform and instruments) delivery platform based on the robot assisted colon

intubation system


- Surgical site and instrument launch platform stabilization methodology (vision driven static and dynamic motion

control) and hardware based on the robot assisted colon intubation system


- Instrument launch platform and instrument arm architecture (triangulation)


- Position and attitude control hardware architecture for end effector of instrument and control system software


- Wall mounted, passively controlled surgical assistant accessories and delivery hardware





CORE SCIENTIFIC & TECHNOLOGICAL BASIS OF IMPROVED COLON INTUBATION



1. The colon intubation, i.e., colonoscope insertion/withdrawal and clinical (colon preparation, inspection for

abnormalities and diagnostic/therapeutic intervention, e.g., polypectomy) operations are physically separated. The

massive and bulky exoskeleton structure of conventional colonoscope needed solely for intubation operation is

entirely removed or substantially optimized to free up or reduce the area in the finite cross section of colonoscope

occupied by the exoskeleton structure thus enabling improvements of the clinical operation subsystem taking

advantage of the area newly made available.


2. The known technical difficulties of intubating the colon is eased by employing a Push-Pull intubation operation,

that is, an alternating actions of pushing the endoscope and pulling the colon over the endoscope to maintain a

smooth curvature in and prevent looping of the endoscope rather than by a Push operation alone, that is, forcefully

pushing the endoscope through the tortuous colon anatomy.


3. The Push-Pull intubation action, either done manually or with robotic assistance, is enabled by an overtube

designed to selectively engage to manipulate and disengage the colon.





A ROBOTIC ASSISTED, HYBRID ENDOLUMINAL SURGERY SYSTEM FOR LOWER GI TRACT



1. Hardwares for control of position of instrument and atitude of end effector physically and functionally decoupled


2. End effector with sufficient number of degrees of freedom for smooth and harmonious movement


3. Endoscopically delivered adjunct devices for bowel orientation manipulation and stabilization


4. Operational precision and surgeon friendly operation console typical of modern robotic assisted surgery system


5. Enabled by the robotic assisted colon intubation system





COLLABORATION PROPOSED (GUIDELINE)



1. Aim



- Establish dominance in the population CRC screening colonoscopy market (>35 million procedures/year even at

suboptimal population compliance) by providing new technological solutions for the persistent and intractable

problems of colon intubation enabling: (1) efficient, streamlined and less painful (reduced sedation) procedure and (2)

onsite supplementary colon preparation (mild at-home, self administered colon preparation requirements for

patient).



- Establish a new technological foundation for revolutionizing the lower and upper GI endoscopy markets

spanning diagnosis and therapeutic intervention for the GI abnormalities with conventional manual tools, e.g., snares

and forceps, and robotically controlled surgical tools adapted for use with GI endoscopes, e.g., articulating

instruments with multiple degrees of freedom.




2. A "Build-to-Buy" Model: Joint effort with technical/financial contributions from collaboration partners




- Endoscape Colonoscopy:


-- Architecture and device designs for hand-held and robotic assisted colon intubation subsystems

-- Architectural designs of specialty GI endoscope instruments and accessory/adjunct instruments




- Prospective Partner(s):


-- A manufacturer of currently marketed GI endoscopy products: Specialty GI endoscope instruments and

accessory/adjunct instruments for hand-held and robotic assisted GI endoscopy


-- A manufacturer of robotic assisted surgery system: Robotic assisted GI endoscopy system hardware and opearting

system software, and associated endoluminal surgical instruments




- Financial Partner(s)




- Exit through sale of Endoscape Colonoscopy as a whole or in parts (hand-held and robotic assisted) to a

collaboration partner(s)






HEADQUARTER: SANTA CLARA, CA, USA