US-12622633-B2 - System for monitoring anastomoses

US12622633B2US 12622633 B2US12622633 B2US 12622633B2US-12622633-B2

Abstract

A system for monitoring anastomoses is provided. The system includes a probe and a control module in connection with the probe. The probe includes optical sensor assemblies. Each sensor assembly includes an optical emitter and an optical detector The sensor assemblies are spaced from one another so that following insertion of the probe into a lumen of a subject, the sensor assemblies can interrogate limbs of an anastomosis. The control module is configured to operate the optical emitters to illuminate respective limbs of the anastomosis and to receive signals from the optical detectors, the signals being representative of light reflected by tissue of the limbs. The control module is also configured to compare signals from the detectors and derive therefrom an indication of tissue vitality in the lumen of either side of the anastomosis.

Inventors

Panicos KYRIACOU
Mohamed THAHA
Karthik BUDIDHA

Assignees

City, University of London

Dates

Publication Date: 20260512
Application Date: 20200824
Priority Date: 20190823

Claims (16)

1 . A system for monitoring anastomoses, the system comprising: a probe for interluminal insertion into a subject; and a control module for connection to said probe, wherein: the probe comprises first and second optical sensor assemblies, said first and second optical sensor assemblies each comprising an optical emitter operable to emit light and an optical detector for detecting light emitted by said optical emitter, said first and second sensor assemblies being spaced from one another so that following insertion of said probe into a lumen of said subject said first sensor assembly can be utilized to interrogate a first limb of an anastomosis and said second sensor assembly can be utilized to interrogate a second limb of said anastomosis, and the control module is configured to be capable of operating said optical emitters of said first and second optical sensor assemblies for to illuminate said first and second limbs of said anastomosis respectively, and to be capable of receiving signals from the optical detectors of said first and second optical sensor assemblies, signals from the optical detector of said first optical sensor assembly being representative of light reflected by tissue of said first limb of said anastomosis and signals from the optical detector of said second optical sensor assembly being representative of light reflected by tissue of said second limb of said anastomosis, said control module being further configured to compare the signals from the detectors of said first and second sensor assemblies with one another and derive therefrom an indication of tissue vitality in the lumen of either side of said anastomosis; said control module being further configured to derive from the signals from the optical detectors of said first and second optical sensor assemblies an indication of tissue vitality selected from one or more of: tissue perfusion, blood flow, blood oxygenation, perfusion index (PI), incoming blood perfusion (PI), oxygen delivery (SpO2 and HbO2), oxygen consumption (HHb), and total blood volumes (tHb); and to determine if the indication of derived tissue vitality proximally of said anastomosis should vary by a predetermined degree from the indication of derived tissue vitality distally of said anastomosis.
2 . The system according to claim 1 , wherein the optical emitters of said first and second sensor assemblies are substantially identical.
3 . The system according to claim 1 , wherein said first and second optical assemblies are coupled to a common elongate support, said first optical assembly being coupled to said support near a first end of the support, and said second optical assembly being coupled to said support near a second end of the support.
4 . The system according to claim 3 , wherein said elongate support comprises a planar body having opposing first and second faces, said first and second optical assemblies being coupled to said first face.
5 . The system according to claim 4 , wherein said elongate support comprises a printed circuit board having circuitry for electrically coupling said first and second sensor assemblies to said control module.
6 . The system according to claim 1 , wherein said optical sensor assemblies each comprise a plurality of optical emitters that are configured to emit light at different wavelengths to one another.
7 . The system according to claim 6 , wherein said detectors of said optical sensor assemblies are configured to be capable of detecting light from said plurality of emitters.
8 . The system according to claim 3 , wherein said elongate support is sized for insertion into a catheter that can be inserted into said lumen.
9 . The system according to claim 1 , wherein said probe can be decoupled from said control module for disposal.
10 . The system according to claim 1 , wherein said predetermined degree is chosen to be a degree in tissue vitality change that could be indicative of a potential failure of said anastomosis.
11 . The system according to claim 10 , wherein said control module is operable to alert an operator of said system if the indication of derived tissue vitality proximally of said anastomosis should vary by said predetermined degree from the indication of derived tissue vitality distally of said anastomosis.
12 . The system according to claim 11 , wherein said control module comprises a display and a display controller, said display controller being operable to control said display to display the indication of derived tissue vitality for the lumen distally of said anastomosis.
13 . The system according to claim 12 , wherein said display controller is operable to control said display to display the indication of derived tissue vitality for the lumen proximally of said anastomosis.
14 . The system according to claim 13 , wherein said display controller is operable to control said display to display an indication of tissue vitality difference between the indication of derived tissue vitality for the lumen proximally of said anastomosis and the indication of derived tissue vitality for the lumen distally of said anastomosis.
15 . A system for monitoring anastomoses, the system comprising: a probe for insertion into a lumen of a subject and a control module for connection to said probe, wherein: the probe comprises first and second optical sensor assemblies, said first and second optical sensor assemblies each comprising an optical emitter operable to emit light and an optical detector for detecting light emitted by said optical emitter, said first and second sensor assemblies being spaced from one another so that following insertion of said probe into the lumen of said subject said first sensor assembly can be utilized to interrogate a first limb of an anastomosis and said second sensor assembly can be utilized to interrogate a second limb of said anastomosis, the control module is configured to be capable of operating said optical emitters of said first and second optical sensor assemblies to illuminate said first and second limbs of said anastomosis respectively, and to be capable of receiving signals from the optical detectors of said first and second optical sensor assemblies, signals from the optical detector of said first optical sensor assembly being representative of light reflected by tissue of said first limb of said anastomosis and signals from the optical detector of said second optical sensor assembly being representative of light reflected by tissue of said second limb of said anastomosis, said control module being further configured to compare the signals from the detectors of said first and second sensor assemblies with one another and derive therefrom an indication of tissue vitality in the first and second limbs of the lumen either side of said anastomosis, said indication of tissue vitality for both said first limb and said second limb is selected from one or more of tissue perfusion, blood flow, blood oxygenation, perfusion index (PI), incoming blood perfusion (PI), oxygen delivery (SpO2 and HbO2), oxygen consumption (HHb), and total blood volumes (tHb), and said control module is configured to alert an operator of said system if the indication of tissue vitality in said first limb of said anastomosis should vary by a predetermined degree from the indication of tissue vitality in said second limb of said anastomosis, said predetermined degree being chosen to be a degree in tissue vitality change that is indicative of a potential failure of said anastomosis.
16 . A system for monitoring anastomoses, the system comprising a probe for interluminal insertion into a subject and a control module for connection to said probe, wherein: the probe comprises first and second optical sensor assemblies, said first and second optical sensor assemblies each comprising an optical emitter operable to emit light and an optical detector for detecting light emitted by said optical emitter, said first and second sensor assemblies being spaced from one another so that following insertion of said probe into a lumen of said subject said first sensor assembly can be utilised to interrogate a first limb of an anastomosis and said second sensor assembly can be utilised to interrogate a second limb of said anastomosis; and the control module is configured to be capable of operating said optical emitters of said first and second optical sensor assemblies for illumination of said first and second limbs of said anastomosis respectively, and to be capable of receiving signals from the optical detectors of said first and second optical sensor assemblies, signals from the optical detector of said first optical sensor assembly being representative of light reflected by tissue of said first limb of said anastomosis and signals from the optical detector of said second optical sensor assembly being representative of light reflected by tissue of said second limb of said anastomosis, said control module being further configured to: compare the signals from the detectors of said first and second sensor assemblies with one another and derive therefrom an indication of tissue vitality in the lumen either side of said anastomosis, and to determine if the indication of derived tissue vitality proximally of said anastomosis should vary by a predetermined degree from the indication of derived tissue vitality distally of said anastomosis.

Description

CROSS-REFERENCE TO RELATED APPLICATIONS This application claims priority under 35 U.S.C. § 371 as a national stage application of PCT Application No. PCT/EP2020/073604, filed Aug. 24, 2020, which claims priority to GB 1912161.5, filed Aug. 23, 2019, each of which is hereby incorporated herein by reference in its entirety. FIELD This disclosure relates to a system for monitoring anastomoses, particularly but not exclusively to a system for monitoring intestinal anastomoses. An intraluminal probe and a control module for such systems are also disclosed. In the following disclosure reference is made to intestinal and, in particular, colorectal anastomoses; but it will be appreciated that the system and components disclosed herein may be used in a variety of other applications and hence the scope of the present disclosure should not be construed as being limited only to the particular applications described herein. BACKGROUND Intestinal resection is a common surgical procedure in both elective and emergency settings. For colorectal cancer (CRC), the third most common malignancy with some 40,000 new cases per annum in the United Kingdom, it can be the only curative treatment. Intestinal resections are also carried out for a variety of non-cancer conditions including inflammatory bowel disease (Crohn's disease, ulcerative colitis), diverticular disease, ischaemia of bowel, and traumatic bowel injuries. From a patient's perspective, regaining continuity of the bowel after intestinal resection and being able to empty their bowel contents through their natural back passage is of paramount importance. Failure to achieve this can result in a loss of dignity and a reduced quality of life. After intestinal resection, surgeons restore the continuity of the bowel by creating an intestinal anastomosis where the two cut ends of the intestine are joined together, typically with sutures or by using a stapling device. In recent times, as technology advances and instrumentation improves, an increasing number of restorative intestinal surgeries are tending to be carried out. Currently, a primary anastomosis tends to be considered to be the gold standard even in very low rectal cancers. However, in a significantly high number of cases, an intestinal anastomosis cannot be performed and these patients are left with either a temporary or a permanent stoma. This is mainly due to concerns about adequate disease clearance (particularly for patients with low rectal cancers), concerns about the safe healing of an anastomosis, or to an anastomotic leak. The latter two primarily occur due to lack of sufficient blood supply to the site of the anastomosis. For the normal healing process of an anastomosis to take place, it must have ample tissue perfusion to deliver the influx of inflammatory cells, growth factors, and oxygen. Insufficient microcirculation can lead to ischaemia which when prolonged can result in tissue necrosis, and subsequently an anastomotic leak. Anastomotic leaks cause spillage of intestinal contents leading to severe sepsis, multi-organ dysfunction and death in up to 32% of patients especially when the diagnosis and subsequent intervention is delayed. The incidence of an anastomotic leak following colonic resection is reported to be as high as 20%. Successful management of the risk of an anastomotic leak requires early identification and early intervention prior to the establishment of systemic sepsis and organ failure. Often these patients require emergency re-laparotomy, take down of the failed anastomosis, clearance of the intra-abdominal/pelvic contamination and diversion of faecal stream by creation of a stoma, either an ileostomy or a colostomy. In many instances, such stomas are never reversed leading to persistently poor quality of life. Left sided anastomosis, particularly low rectal anastomosis tends to be more prone to failure and is often protected with a de-functioning temporary ileostomy (in up to 73% of patients). Such patients require a second operation to reverse the ileostomy and the incidence of such stomas becoming permanent are as high as 25%. The presence of a stoma also exposes the patients to a higher risk of surgical site infections. Ability to accurately and dynamically measure perfusion to the intestine would allow surgeons to create a greater number of healthy anastomosis; objectively predict their successful healing; reduce the need for defunctioning ileostomies; and pre-empt timely interventions on a failing anastomosis—thereby reducing the morbidity and mortality associated with anastomotic leaks. Despite this understanding, accurate monitoring of intestinal circulation in patients with a newly formed anastomosis continues to be a distant goal. Current methods for intra-operative assessment of intestinal viability include visual confirmation of the normal appearance and colour of intestinal serosa, visible and palpable pulsations in the mesenteric arterial arcade, presence of intestinal per