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Saving patients from invasive colectomies via trans-endoscopic steerable instrument sheaths

Award Number: R01EB032385
ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING
OPDIV: NIH
AWARD CLASS: DISCRETIONARY
AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)
PERIOD OF PERFORMANCE START DATE: 07/01/2022
PERIOD OF PERFORMANCE END DATE: 03/31/2026

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Saving patients from invasive colectomies via trans-endoscopic steerable instrument sheaths - Project Summary/Abstract The objective of this proposal is to create dexterous steerable instrument sheaths that enable patients who currently are subject to invasive surgeries to receive minimally invasive endoscopic interventions. Clinical signiﬁcance comes from (1) the high incidence of colon lesions – there are 6.3 million colonoscopies per year with 50% ﬁnding lesions, and (2) the difﬁculty of removing a subset of these (those with challenging sizes, shapes, or locations) due to the limited dexterity of conventional endoscopes. This results in over 60,000 patients per year in the USA with colon lesions that the very best endoscopists have demonstrated can be safely removed with an outpatient endoscopic procedure, who are instead subjected to invasive surgery to remove a section of their colon (i.e. colectomy surgery). This occurs because of the dexterity gap between the best endoscopists and typical endoscopists. We aim to close this gap with the new device described in this proposal. The innovation in our work is a new steerable sheath concept that harnesses elastic asymmetry to provide dexterity at the tip of a colonoscope. This dexterity reduces the difﬁculty of removing challenging lesions endo- scopically. Our controllably deﬂectable, thin-walled, tube-like device will be small enough to pass through the port of a conventional endoscope, while providing a large open lumen for surgical instruments to pass through. Its innovative mechanical design accomplishes this by dispensing with conventional pull-wires, hinges, and other bulky force transmission elements in favor of the push-pull interaction of two thin-walled tubes, which bend con- trollably via interacting regions of stiffness asymmetry at their tips. Our approach consists of three Speciﬁc Aims. Aim 1 addresses the construction of the steerable sheaths and their actuation systems. Aim 2 focuses on enabling dexterous physician control via a physician interface console, and optimization of device dexterity. Aim 3 consists of ex vivo and in vivo porcine experiments to demonstrate that the device enables physicians new to endoscopic dissection to perform with accuracy and efﬁciency similar to what elite endoscopists have shown can effectively and safely treat the 60,000 patients mentioned above. The endpoint of this project will be a device that has been validated in an animal model, setting the stage for rapid clinical translation after successful completion of this R01.


Issue Date FY	Funding FY	Legal Entity Name	Legal Entity Address	Legal Entity City	Legal Entity State	Legal Entity Zip Code	Legal Entity COUNTY	Legal Entity COUNTRY	Assistance Listing	Award Code	Budget Year	Action Date	Action Type	Action Amount

Issue Date FY: 2026 ( Subtotal = $0 )
2026	2025	UNIVERSITY OF TENNESSEE	201 ANDY HOLT TOWER	KNOXVILLE	TN	37996	KNOX	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	4	11/25/2025	NON-COMPETING CONTINUATION	$0
														Subtotal = $0

Issue Date FY: 2025 ( Subtotal = $574,687 )
2025	2025	UNIVERSITY OF TENNESSEE	201 ANDY HOLT TOWER	KNOXVILLE	TN	37996	KNOX	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	4	3/27/2025	NON-COMPETING CONTINUATION	$574,687
														Subtotal = $574,687

Issue Date FY: 2024 ( Subtotal = $568,802 )
2024	2024	UNIVERSITY OF TENNESSEE	201 ANDY HOLT TOWER	KNOXVILLE	TN	37996	KNOX	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	3	5/3/2024	NON-COMPETING CONTINUATION	$568,802
														Subtotal = $568,802

Issue Date FY: 2023 ( Subtotal = $601,394 )
2023	2023	UNIVERSITY OF TENNESSEE	201 ANDY HOLT TOWER	KNOXVILLE	TN	37996	KNOX	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	2	4/7/2023	NON-COMPETING CONTINUATION	$601,394
														Subtotal = $601,394

Issue Date FY: 2022 ( Subtotal = $625,441 )
2022	2022	UNIVERSITY OF TENNESSEE	1331 CIR PARK DR	KNOXVILLE	TN	37916	KNOX	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	000	1	6/24/2022	NEW	$625,480
2022	2022	UNIVERSITY OF TENNESSEE	1331 CIR PARK DR	KNOXVILLE	TN	37916	KNOX	USA	Discovery and Applied Research for Technological Innovations to Improve Human Health	001	1	8/3/2022	NEW	-$39
														Subtotal = $625,441

Grand Total All Awards = $2,370,324

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Saving patients from invasive colectomies via trans-endoscopic steerable instrument sheaths

Award Number: R01EB032385

ORGANIZATION: NATIONAL INSTITUTE Of BIOMEDICAL IMAGING & BIOENGINEERING

OPDIV: NIH

AWARD CLASS: DISCRETIONARY

AWARD ACTIVITY TYPE: SCIENTIFIC/HEALTH RESEARCH (INCLUDES SURVEYS)

PERIOD OF PERFORMANCE START DATE: 07/01/2022

PERIOD OF PERFORMANCE END DATE: 03/31/2026

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