CN-122005992-A - Colonoscopy catheter system with intestinal wall tension and temperature sensing feedback

CN122005992ACN 122005992 ACN122005992 ACN 122005992ACN-122005992-A

Abstract

The invention provides a colon dialysis catheter system with intestinal wall tension and temperature sensing feedback, which comprises a colon dialysis catheter body, wherein the colon dialysis catheter body is a multi-cavity flexible tube body which can be inserted into a colon cavity through anus, the catheter body is made of medical flexible high polymer materials, a supporting framework is axially arranged in a catheter wall, a plurality of chordae are circumferentially arranged along the catheter, the number of the chordae is N, one end of each chordae is fixed on a flexible section at the distal end of the catheter, the other end of each chordae is connected with a chordae driving mechanism at the proximal end of the catheter, and the chordae driving mechanism is used for adjusting the bending posture and the local rigidity of the distal end of the catheter in the colon cavity through pulling or loosening the chordae. The intestinal wall tension sensing array and the multipoint temperature sensing are integrated, the central control module is used for carrying out fusion analysis on multi-source data such as tension, temperature and the like, dynamically calculating a risk index, adjusting the perfusion flow, the negative pressure drainage and the catheter posture in a linkage way, and switching the characteristic weights and the threshold values according to different clinical scenes.

Inventors

Ao Qiangguo
WU ZHEN
CHEN LING
GUO JIAYU
HE XUWEI
LI MENGKUN

Assignees

中国人民解放军总医院第二医学中心

Dates

Publication Date: 20260512
Application Date: 20251118

Claims (9)

1. A colonoscopy catheter system with intestinal wall tension and temperature sensing feedback, comprising: The colon dialysis catheter body is a multi-cavity flexible tube body which can be inserted into a colon cavity through anus, the catheter body is made of medical flexible polymer materials, a supporting framework is arranged in the catheter wall along the axial direction, a plurality of chordae are arranged along the circumferential direction of the catheter, the number of the chordae is N, N is more than or equal to 3, one end of each chordae is fixed on a flexible section at the distal end of the catheter, the other end of each chordae is connected with a chordae driving mechanism at the proximal end of the catheter, and the chordae driving mechanism is used for adjusting the bending posture and the local rigidity of the distal end of the catheter in the colon cavity through pulling or loosening the chordae; The intestinal wall tension sensor array is arranged on the outer wall of the flexible section at the far end of the catheter body, a plurality of rings of annular sensing belts are axially arranged at intervals along the catheter, a plurality of force-sensitive sensing elements are arranged on each ring of annular sensing belts along the circumference of the catheter, and the force-sensitive sensing elements are used for outputting tension signals related to colon wall contact stress of a corresponding annular area; the temperature sensor unit is arranged in the catheter body and used for monitoring local temperature in the colon cavity and the temperature of the dialyzate, and comprises a first temperature sensor and a second temperature sensor, wherein the first temperature sensor is attached to the outer wall of the distal end of the catheter and used for detecting the temperature of the tip of the catheter close to a mucous membrane, and the second temperature sensor is arranged in the catheter cavity and close to the dialyzate outlet and used for detecting the temperature of the dialyzate outlet; The perfusion and drainage module is communicated with the perfusion cavity and the drainage cavity of the catheter body and comprises a micro perfusion pump and a negative pressure drainage unit, wherein the micro perfusion pump is used for conveying dialysate into a colon cavity at an adjustable flow rate, and the negative pressure drainage unit is used for sucking and decompressing gas and/or liquid in the colon cavity when needed; The central control module is electrically connected with the intestinal wall tension sensor array, the temperature sensor unit, the perfusion and drainage module and the tendon driving mechanism, The central control module includes: the data acquisition unit is used for acquiring tension signals of the annular sensor belts and temperature signals of the temperature sensors at a preset sampling frequency, and calculating instantaneous values, change rates and fluctuation statistics of the tension and the temperature in a sliding time window; The Risk assessment unit is used for carrying out normalization processing on the tension and temperature characteristics in the sliding time window, calculating a combined Risk index M-Risk according to pre-stored characteristic weights, simultaneously representing the stress state and the local temperature state of the colon wall, and comparing the combined Risk index with a preset at least two-stage Risk threshold to judge the Risk level of the current dialysis process; The control unit is used for keeping the current perfusion flow and the catheter posture when the risk level is safe, reducing the flow of the micro perfusion pump and/or intermittently controlling the negative pressure drainage unit to slowly release pressure when the risk level is early warning, driving the tendon driving mechanism to adjust the bending posture of the distal end of the catheter according to the stress distribution output by the intestinal wall tension sensor array, immediately stopping the output of the micro perfusion pump and continuously controlling the negative pressure drainage unit to release pressure when the risk level is high risk, simultaneously controlling the tendon driving mechanism to release or reversely adjust each tendon to enable the distal end of the catheter to withdraw from a high-pressure area, and triggering the alarm system to output a dangerous prompt to medical staff, thereby forming the closed loop safety control of colon dialysis based on intestinal wall tension and temperature sensing feedback.
2. The colon dialysis catheter system with intestinal wall tension and temperature sensing feedback according to claim 1, wherein in the intestinal wall tension sensor array, the distance between the annular sensor strips along the axial direction of the catheter is 2-10 mm, each annular sensor strip comprises m force sensitive sensor elements, m is more than or equal to 3 and less than or equal to 12, and the central control module reconstructs the intestinal wall contact stress distribution of the circumferential-axial direction of the distal end of the catheter according to the tension signals of each annular sensor strip and each circumferential position, so as to identify the local stress concentration area.
3. The colonoscopy catheter system with intestinal wall tension and temperature sensing feedback of claim 1, wherein the Risk assessment unit calculates the joint Risk index M-Risk using the example formula: Wherein P- max is the normalized value of the maximum contact pressure in the sliding time window, sigma-P is the normalized value of the tension variance of the annular sensor belt, deltaP- ring is the normalized value of the tension difference between adjacent annular sensor belts, T- mucosa is the normalized deviation of the mucous membrane temperature detected by the first temperature sensor relative to the target temperature, dT-is the normalized value of the mucous membrane temperature change rate, w 1 ∼w 5 is the weight coefficient of the corresponding feature, and the conditions are satisfied 。
4. The colonoscopy catheter system with intestinal wall tension and temperature sensing feedback according to claim 1, wherein the central control module further comprises a scene mode management unit storing at least three sets of feature weights and risk threshold parameter sets for different clinical scenes including a pre-operative colon cleansing lavage scene, a post-operative colon drainage scene and a local thermal perfusion treatment scene, the scene mode management unit loading the corresponding parameter sets according to user selection, increasing the weights of the tension and pressure related features in the pre-operative colon cleansing lavage scene and setting the maximum contact pressure threshold at 3-5 kpa, increasing the weights of the temperature deviation and temperature rise rate features in the local thermal perfusion treatment scene and setting the temperature threshold at 42-43 ℃.
5. The colonoscopy catheter system with intestinal wall tension and temperature sensing feedback according to claim 4, wherein the central control module comprises a state classification subunit, the state classification subunit takes a support vector machine model of a radial basis function as input, which takes feature vectors composed of a joint Risk index M-Risk and the multi-modal features, and classifies the colonoscopy state into three types of safety, early warning and high Risk, the support vector machine model is obtained by training historical colonoscopy data containing safety, early warning and high Risk samples, and optimizes penalty coefficients and nuclear parameters through cross validation.
6. The colon dialysis catheter system with intestinal wall tension and temperature sensing feedback of claim 5, wherein the central control module comprises a dynamic threshold adjustment unit configured to count the distribution characteristics of the joint Risk index M-Risk over a preset period of time, fine-tune the early warning threshold and the high Risk threshold based on the mean and standard deviation or quantile information, and a feature weight adjustment unit configured to adjust the weights of the tension related features and the temperature related features with a degree of clipping based on recent Risk events and control effects to reduce unnecessary perfusion interruptions while ensuring safety.
7. The colon dialysis catheter system with intestinal wall tension and temperature sensing feedback according to claim 4, wherein the central control module is used for controlling the micro perfusion pump to reduce the perfusion flow to 50% -80% of the original set flow when the joint Risk index M-Risk is at an early warning level and periodically starting the negative pressure drainage unit for slow pressure relief in a short time under the condition that the joint Risk index M-Risk is at a high Risk level, immediately stopping the output of the micro perfusion pump and continuously controlling the negative pressure drainage unit for pressure relief until the estimated internal pressure is lower than a set safety value, and driving the tendon driving mechanism to adjust the distal bending gesture of the catheter to avoid a local pressure-bearing area.
8. The colonoscopy catheter system with intestinal wall tension and temperature sensing feedback of claim 7, wherein the central control module regards slow tension rise and reduced drainage volume as drainage unsmooth Risk features in a postoperative colonoscopy scenario, controls the micro perfusion pump to perform a small flow flush and controls the negative pressure drainage unit to perform a small intensity pulse aspiration to attempt to unblock the drainage path when a catheter tension baseline rise is observed and the drainage volume is below a preset lower limit for a continuous plurality of sliding time windows, maintains a drainage pause state and prompts medical personnel to check treatment by an alarm if the joint Risk index M-Risk remains high.
9. The colon dialysis catheter system with intestinal wall tension and temperature sensing feedback of claim 5, wherein the central control module comprises a subjective discomfort prediction unit for establishing a prediction model based on a correlation between historic patient subjective pain scores and objective sensing parameters such as catheter tension and temperature, and calculating subjective discomfort prediction values according to real-time tension peaks, contact pressure and temperature deviations during colon dialysis, and when the subjective discomfort prediction values exceed a preset comfort threshold, the control unit is configured to reduce perfusion flow in advance, lengthen perfusion interval time or temporarily suspend dialysis to reduce patient subjective discomfort and optimize clinical operation experience even if the joint Risk index M-Risk is still below an early warning threshold.

Description

Colonoscopy catheter system with intestinal wall tension and temperature sensing feedback Technical Field The invention belongs to the field of colon dialysis, and particularly relates to a colon dialysis catheter system with intestinal wall tension and temperature sensing feedback. Background Colonic lavage and colonic dialysis are used as a technique for injecting a large amount of liquid through intestinal tracts, removing toxin and fecal load, and are applied to various scenes such as chronic constipation, hepatic encephalopathy, preoperative intestinal tract preparation and the like. The common clinical equipment is in the form of a colon dialysis machine and a disposable catheter or an intestinal lavage system and an enema tube, warm water or dialysate is injected into the colon from the anus through a pressure pump and then is discharged through the catheter or naturally, so that the purposes of cleaning, relieving burden or local treatment are achieved. Because the operation object is a thin-walled colon, and a large liquid amount and a certain pressure are often used in the perfusion process, the guidelines and the health departments of various countries emphasize the safety problem on colon lavage and colon hydrotherapy, and especially prevent serious complications such as colon perforation, infection, electrolyte disturbance and the like. In the prior art, on the one hand there is a risk of hydraulic and mechanical damage. The literature reports that high pressure, high flow enemas or colonic lavages can lead to hydraulic colonic perforation, especially in anatomical weakness parts such as sigmoid colon, and also shows that the lavage head or cannula head directly mechanically breaks the intestinal wall to cause perforation. In so-called "high volume colon lavage", early literature has suggested risks of rectal/colonic perforation, infection, water poisoning and electrolyte disturbance due to large perfusion volumes and varying operation criteria. In order to reduce the risk related to the water pressure, some commercial devices and regulations require a pressure limiting valve and a back pressure releasing structure, and operators can adjust the flow rate and the pressure by observing subjective manifestations such as abdominal distension, pain and the like according to patient complaints and experiences. However, such safety measures depend on the pipeline pressure or pump outlet pressure, so that it is difficult to timely and accurately reflect the actual stress situation of a part of a certain colon wall, and especially the stress concentration state of 'the whole pressure is not high yet, but the local catheter is pressed against the mucous membrane' cannot be identified. On the other hand, temperature and cleaning medium temperature control are also lacking in the prior art. Most colon lavage devices only set a simple temperature control or temperature limiting system at the water source end to keep the lavage water in a section 'close to the body temperature', but the heat loss of the perfusate in the pipeline and the temperature gradient generated by local detention in the colon often lack effective monitoring. Research and clinical experience suggest that supercooled perfusate can induce intestinal cramps, discomfort and even reflex cardiovascular reactions, whereas overheated liquids or local heat accumulation can burn or exacerbate inflammatory reactions to mucous membranes. Existing lavage devices generally only indirectly estimate intestinal lumen temperature through a single point temperature probe or outlet water temperature display, lacking real-time monitoring of catheter tip proximity mucosal temperature and active protection control based on temperature rate of change. In addition, in terms of catheter body structure, flexible gastrointestinal catheters, enteroscopes and other instruments have been designed with multiple joints or bends to improve passability in the intestinal lumen, and tendon actuation and tip contact force sensing techniques have been explored in some flexible endoscope robots to guide insertion force and reduce perforation risk. However, such force sensing is designed for the 'cannula guiding/navigating' scene, usually, the distal contact force feedback is used to assist the doctor in manual adjustment operation, and the intestinal wall contact force signal is rarely combined with the working condition of colon dialysis/lavage, so that the intestinal wall contact force signal is directly incorporated into the multi-execution-end linkage control of perfusion flow, negative pressure drainage and catheter gesture, and the systematic safety strategy for the specific scene of colon dialysis is lacking. The existing colon dialysis catheter is mostly a single or double-cavity catheter, has only simple perfusion and drainage functions, lacks tension sensing arrays arranged along the axial direction and the circumferential direction, cannot form 'space imaging' of a