Path Forward | The First Step





ARCHITECTURE OF THE NEXT GENERATION STAPLER INSTRUMENT PLATFORM | Generation 1




(1) A First Handheld Multifunction Stapler Instrument :


- An Instrument Handle Equivalent to a Type of Stapler Handle (Manual or Powered) in Wide Use & Detachable Tool

Assembly*


- An Instrument Handle with A Unique Set 1 of Tool Assembly (Staple Reload) for Each Type of Organ


- A (Optional) Built-in Overload Indicator 1 for Informed Staple Selection & Prevention of Instrument Malfunction



* An exemplary instrument platform is shown below for illustrative purpose only



Tool Assembly 1 - A Stapler Based on Novel Tissue Conditioning Technologies with Wide Tissue Thickness Coverage

Tool Assembly 2 - A Tissue Intelligence Device 1 for Preventing The Most Preventable Adverse Events

Tool Assembly 3 - A Remedial Stapler (An Optional Supplement to Tool Assembly 1)



(2) A Second Handheld Multifunction Stapler Instrument :


- An Instrument Handle Equivalent to a Type of Stapler Handle (Manual or Powered) in Wide Use & Detachable Tool

Assembly Modified to Provide a Full Design Compression Upon Initial Closure of End Effector*,**


- An Instrument Handle with A Unique Set 2 of Tool Assembly (Staple Reload) for Each Type of Organ


- A (Optional) Built-in Overload Indicator 2 for Informed Staple Selection & Prevention of Instrument Malfunction



* An exemplary instrument platform is shown below for illustrative purpose only

** See paragraph (5) in the previous section. Modification reduces frequencies and severities of certain adverse events. Related IPs to be made available.



Tool Assembly 1 - A Stapler Based on Novel Tissue Conditioning Technologies with Wide Tissue Thickness Coverage

Tool Assembly 2 - A Tissue Intelligence Device 1 for Preventing The Most Preventable Adverse Events

Tool Assembly 3 - A Remedial Stapler (An Optional Supplement to Tool Assembly 1)



Path Forward | The First Step, Extended





NOVEL METHOD OF PRECISION LAPAROSCOPIC SURGICAL STAPLING




(1) Precision tissue compression enabled by the tissue information provided by the Tissue Intelligence Device 1


(2) Staple firing operation completely or selectively decoupled from supplementary tissue compression


(3) Compatible with the two common endoscopic stapler instrument architectures with adaptations


(4) Substantial reduction expected in the number of malformed staples, especially in thick tissue


(5) Capable of accommodating tissue up to 4 mm in thickness in 12 mm and 15 mm diameter profiles



ARCHITECTURE OF STAPLER INSTRUMENT PLATFORM | Generation 2




(1) Newly designed to embody the novel method of surgical stapling*


(2) Single stroke staple firing operation



* An exemplary instrument platform is shown below for illustrative purpose only



ARCHITECTURE OF STAPLER INSTRUMENT PLATFORM | Generation 3




(1) See section "Path Forward | And Beyond".



SURGICAL STAPLERS & ADJUNCT TOOL ASSEMBLIES / DEVICES | Robot Assisted Surgery Systems




All Intellectual Properties related to the Stapler Platform & Associated Rights to Tissue Intelligence Devices to be

Exclusively Licensed to A Robot Assisted Surgery Platform Manufacturer



Path Forward | The Second Step





Tool Assembly 4 or A Specialty Cartridge 1 - An Analyzer Device 1 for Intra-operative Characterization of Staple Line* :


(1) Performs A Quantitative & Parametric Evaluation of Staple Line Quality Initially Including :


A Mechanical Property of Stapled Tissue Under Compression

A Lengthwise Uniformity of A Mechanical Property of Stapled Tissue


(2) Provides A Scientific Basis for Correlating Staple Line Characteristics with Clinical Performance under

Localized, Quasi-static & Periodic Loads (Hemostasis)



* Not for use on a staple line reinforced with a reinforcement strip

* For use only on a flat staple line, i.e., no steps or dimples



A Specialty Hand-held Instrument - An Analyzer Device 2 for Intra-operative Characterization of Staple Line* :


(1) Performs A Quantitative & Parametric Evaluation of Staple Line Quality Initially Including :


A Mechanical Property of Stapled Tissue Under Extension

A Lengthwise Uniformity of A Mechanical Property of Stapled Tissue


(2) Provides A Scientific Basis for Correlating Staple Line Characteristics with Clinical Performance under

Extended, Dynamic & (Quasi-)Periodic Physiological (Organ Motion) Loads (Organ Content Retention)



* Not for use on a staple line reinforced with a reinforcement strip

* For use only on a flat staple line, i.e., no steps or dimples



Path Forward | The Third Step





Tool Assembly 5 or A Specialty Cartridge 2 - A Specialty Stapler for Lung :


A Staple Arrangement and Staple Design Optimized for Improved Clinical Performance (Prevention of Air Leaks) of

Staple Line under Highly Periodic & Constant, Passively Driven Physiological Motion (Breathing) of a Fixed Load

Pattern Along Staple Line



Path Forward | The Fourth Step





A Specialty Circular Stapler with A Reactive Augmentation :


A Staple Arrangement Designed & Optimized Factoring in Characteristic, Undulating Peristaltic Motion of Colon




&




A Reactive Augmentation Element for Circular (& Linear) Stapler :


(1) Inherent Mechanical Property of Colon Tissue Marginally Adequate for Effective Hemostasis or Organ Content

Retention (Prevention of Staple Line Leaks)


(2) Unlike A Passive Strip Reinforcement, A Reactive Augmentation Element Augments Inherent Mechanical Property of

Colon Tissue upon Actuation by Loads of Physiological Origin, i.e., Blood Pressure & Peristaltic Motion of Colon


(3) Incorporated in Staple Design or Deployed as An Attachment to Staple Line



Path Forward | And Beyond





A Tissue Intelligence Device 2 - Tissue Probe-Analyzer :


Determines an Optimum Tissue Compression based on Mechanical Characteristics





A Next Generation Endoscopic Stapler :


(1) Stapling to a Given Tissue Compression


(2) No Supplementary Tissue Compression During Staple Firing


(3) A First (12mm) & Second (15mm) Instrument with A Single Staple Cartridge


(4) Covers a Full Range of Tissue Thickness


(5) Consistent Staple Formation Performance Irrespective of Tissue Thickness



Leap Forward





Endoscape Surgical is looking to partner with one or more surgical stapler manufacturers active in the surgical

stapling market in China and elsewhere that share its vision for the next generation surgical stapling.



Minimum Eligibility :


(1) Must have a laparoscopic surgical stapling product(s) derived from the market leading surgical stapling product(s).



Partnership Benefits :


(1) Be a first mover(s) in the surgical stapling market in China of patent protected surgical stapling products.

(2) Be a manufacturing partner and/or supplier for the next generation surgical stapling products.



Please reach out to Endoscape Surgical by writing to info@endoscape.com.



Fast Forward





The laparoscopic stapler instrument platforms of the next generation surgical stapling system must have the following

characteristics :



(1) Include an end effector with profile of 15 mm or larger in diameter.


&


(2) Provide a full design compression upon initial closure of end effector.



Exoscape Surgical



Surgical Stapling Reinvented | Open Surgery





(1) A Scientifically Disciplined Approach* to Surgical Stapling** Supported by Tissue Probe Device***



* Staple selection based on the mechanical property of tissue

** Included in Safer Technologies Program (STeP) by FDA, 2022

*** Granted a Breakthrough Device Designation by FDA, 2019

*** Visit Copernicus Surgical for further information.



(2) A Novel Regulatory Framework* for Surgical Stapling



* Included in Safer Technologies Program (STeP) by FDA, 2022



(3) The Adjunct Devices and Knowledge Base* for Disruptive Advancement of Surgical Stapling



* Included in Safer Technologies Program (STeP) by FDA, 2022

* Visit Galileo Surgical Innovation for further information.


FDA Safer Technologies Program FDA Breakthrough Devices Program Copernicus Surgical Galileo Surgical Innovation

SURGICAL STAPLING FOR OPEN SURGERY




(1) Circular Stapler :


- A Legacy architecture for the next generation circular stapler instrument platform*


- Standard staple heights OR


- Standard staple heights expanded to cover the full range of tissue thickness ordinarily found in surgery


- Consistent shape of formed legs of staple irrespective of the height of staple


- Selection of staple height based on tissue mechanical property provided by a Tissue Probe device


- Controlled compression of tissue


- Substantial reduction expected in adverse events due to under-/over-compression of tissue



* An exemplary instrument platform is shown below for illustrative purpose only



(2) Linear Cutter Stapler:


- A Legacy architecture for the next generation linear cutter stapler instrument platform*


- Standard staple types (Blue & Green) OR


- Standard staple types expanded to cover the full range of tissue thickness ordinarily found in surgery


- Selection of staple type based on tissue mechanical property provided by a Tissue Probe device


- Controlled compression of tissue


- Substantial reduction expected in adverse events due to under-/over-compression of tissue



* An exemplary instrument platform is shown below for illustrative purpose only



* The products displayed on this website are under development and have not been cleared or approved for marketing by any regulatory agency. The contents of

this website may be updated in the future without prior notice.