An intestinal mucosal tissue oxygen saturation monitoring monitor

Abstract

This invention relates to the field of medical device technology and discloses an intestinal mucosal tissue oxygen saturation monitoring device, comprising a monitor body, a catheter, a balloon, a near-infrared spectral emission and detection device, a lead wire, an inflation tube, an inflation device, a partition, and tubing one and tubing two. This invention can be used to directly, objectively, and continuously assess changes in small intestinal mucosal microcirculation and tissue oxygen consumption, and can be applied in various clinical environments. Furthermore, it is based on jejunal catheter placement technology, a mature and technically simple technique that can be performed bedside and is suitable for use in primary hospitals and general wards.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, and more specifically, to an intestinal mucosal tissue oxygen saturation monitoring device. Background Technology

[0002] Intestinal tissue is highly susceptible to injury under various stress conditions, such as surgery, trauma, burns, and infections, due to microcirculatory disturbances and imbalances in tissue oxygen supply and demand. Because of a high rate of missed diagnoses, intestinal function recovery is often delayed, and intestinal ischemia and hypoxia further damage the intestinal barrier. Damage to the intestinal barrier, in turn, exacerbates intestinal flora translocation, leading to endotoxin entry into the bloodstream and systemic inflammatory responses, creating a vicious cycle that results in various complications, prolongs the course of the disease, and increases the medical burden. However, intestinal injury is an important clinical symptom that is easily overlooked, mainly because there is a lack of objective and convenient methods for assessing intestinal barrier damage. Unlike biochemical tests for liver and kidney function, blood gas analysis for respiratory function, and lung CT scans, the assessment of intestinal injury is currently limited to the evaluation of clinical symptoms, such as the presence of gastric retention, decreased bowel sounds, nausea, vomiting, abdominal distension, and diarrhea. However, by the time patients develop clinical symptoms, the injury has often already occurred. Once injury has occurred, it further affects a series of treatment strategies, including nutritional therapy, creating a vicious cycle.

[0003] On the other hand, perioperative intestinal microcirculatory disturbances and oxygen supply-demand imbalances in intestinal tissues during abdominal surgery are also key factors affecting postoperative prognosis. Oxygen supply-demand imbalances in intestinal tissues easily lead to poor anastomotic healing and anastomotic leakage. Therefore, strengthening dynamic real-time monitoring and management is crucial for reducing such surgical complications. Currently, monitoring of pH levels in the gastrointestinal mucosa exists, but the method is indirect, suffers from monitoring delays, and is susceptible to various external factors, making it difficult to meet actual clinical needs.

[0004] Near-infrared spectroscopy (NIRS) is a non-invasive method for detecting tissue oxygen saturation. Human tissues exhibit low absorption and high scattering of light with wavelengths between 700 nm and 900 nm. Photons within this range can penetrate approximately 2 cm into the tissue from the skin, allowing for the detection of tissue oxygen saturation. NIRS has been used for over forty years in tissue oxygenation and blood oxygen saturation monitoring. Traditional blood oxygenation devices use photoplethysmography (PPG) to measure arterial oxygen saturation, primarily for preliminary assessment of respiratory oxygenation function. However, PPG measurement cannot measure venous oxygen saturation and is unsuitable for use in areas without a pulse.

[0005] Therefore, there is an urgent need for an indicator that can continuously, intuitively, conveniently, and rapidly evaluate potential intestinal damage, enabling early detection and treatment. Given that effective intestinal microcirculation is fundamental to maintaining intestinal barrier homeostasis, detecting intestinal tissue oxygen saturation can assess intestinal microcirculatory abnormalities at an earlier stage and predict the occurrence of intestinal barrier damage. It can also be used to guide the implementation of treatment measures (such as nutritional therapy) and evaluate treatment efficacy. The small intestine's blood supply comes from the superior mesenteric artery, and most nutrients are absorbed in the small intestine; therefore, monitoring the oxygen saturation of the small intestinal mucosa can provide a more accurate assessment of intestinal damage. Summary of the Invention

[0006] To overcome the aforementioned deficiencies in the existing technology, this invention provides an intestinal mucosal tissue oxygen saturation monitoring device, which can be used to directly, objectively and continuously assess changes in small intestinal tissue mucosal microcirculation and tissue oxygen consumption, and can be used in various clinical environments; moreover, it is based on jejunal catheter placement technology, which is a mature clinical operation technique with low technical difficulty, can be performed at the bedside, and is suitable for implementation in primary hospitals and general wards.

[0007] The above-mentioned technical objective of the present invention is achieved through the following technical solution: an intestinal mucosal tissue oxygen saturation monitoring device, comprising a monitor body and a catheter, an air bladder being sleeved on the outer wall of one end of the catheter, a near-infrared spectral emission and detection device being provided on the outer wall of the air bladder, and the near-infrared spectral emission and detection device being connected to the monitor body via a wire; the air bladder being connected to an inflation tube, and an inflation device being provided at the other end of the inflation tube; a partition being provided inside the catheter, the partition dividing the inside of the catheter into a tube line one and a tube line two, tube line one including two sub-tubes for the wire and the inflation tube to pass through respectively, the end of tube line one near the air bladder being sealed, and tube line two being a nutrient solution delivery tube.

[0008] Furthermore, the near-infrared spectral emission and detection device includes a single-beam near-infrared spectral emitter and a receiving sensing electrode; the single-beam near-infrared spectral emitter and the receiving sensing electrode are integrated on an electrode sheet.

[0009] Furthermore, the emission wavelength of the single-beam near-infrared spectral emitter is 760 nm or 840 nm.

[0010] Furthermore, there are two near-infrared spectral emission and detection devices, which are symmetrically distributed on both sides of the airbag.

[0011] Furthermore, a guide wire is installed inside the second conduit.

[0012] In summary, the present invention has the following beneficial effects: It can be used to directly, objectively, and continuously assess changes in small intestinal mucosal microcirculation and tissue oxygen consumption, and can be applied in various clinical settings, including:

[0013] 1. Existing literature reports that 60% or even higher of patients in intensive care units experience intestinal injury during hospitalization. However, current clinical assessment methods are still limited to evaluating clinical symptoms, such as diarrhea, abdominal distension, constipation, and decreased bowel sounds. This invention, by continuously assessing changes in the microcirculation and oxygen supply and demand of the small intestinal mucosa, plays a role in early diagnosis and early warning.

[0014] 2. For all types of patients requiring enteral nutrition therapy. Patients who have been fasting for various reasons may experience complications such as nutritional intolerance and refeeding syndrome after starting nutritional therapy. Misdiagnosis or missed diagnoses can lead to relapses or worsening of the condition, prolonging hospital stays and increasing the medical burden. This invention can be used to evaluate intestinal mucosal microcirculation and oxygen consumption during nutritional therapy, reflecting the match between enteral nutrition and current intestinal function, identifying whether there is intestinal overload, and allowing for timely adjustments and reductions to decrease the incidence of complications.

[0015] 3. For high-risk patients in the perioperative period of various gastrointestinal surgeries. Patients requiring gastrointestinal surgery due to intestinal obstruction, intestinal artery embolism, tumors, etc., often have intestinal wall edema in the surgical area. However, removing too much intestinal tissue is detrimental to the patient's long-term prognosis, while removing too little tissue increases the risk of postoperative complications. This invention allows for intraoperative visualization and placement of the intestinal segment at the planned resection site, enabling direct evaluation of the blood supply and microcirculation of the intestinal mucosa, indirectly assessing intestinal vitality, and helping surgeons determine the extent of resection. After resection, it can be fixed near the incision site for postoperative evaluation of intestinal recovery at the anastomosis site, facilitating early detection of complications such as intestinal leakage.

[0016] The present invention provides an intestinal mucosal tissue oxygen saturation monitoring device based on jejunal catheter placement technology, which is a mature clinical operation technique with low technical difficulty, can be operated at the bedside, and is suitable for use in primary hospitals and general wards. Attached Figure Description

[0017] Figure 1 This is a front view of an intestinal mucosal tissue oxygen saturation monitoring device according to an embodiment of the present invention;

[0018] Figure 2 This is a structural diagram of the front view of an intestinal mucosal tissue oxygen saturation monitoring device according to an embodiment of the present invention;

[0019] Figure 3 yes Figure 2 Structural diagram at point AA;

[0020] Figure 4 This is a schematic diagram of the intraoperative situation in an embodiment of the present invention;

[0021] In the diagram: 1. Monitor body; 2. Tube; 3. Airbag; 4. Near-infrared spectral emission and detection device; 5. Wire; 6. Inflation tube; 7. Partition; 8. Tube 1; 9. Tube 2. Detailed Implementation

[0022] The following is in conjunction with the appendix Figure 1-4 The present invention will be described in further detail below.

[0023] Example: An intestinal mucosal tissue oxygen saturation monitoring device, such as... Figures 1 to 3 As shown, the device includes a monitor body 1 and a catheter 2. The catheter 2 is 2.5m long. An air bladder 3 is installed on the outer wall of the intestinal end of the catheter 2. Near-infrared spectral emission and detection devices 4 are installed on the outer wall of the air bladder 3. There are two near-infrared spectral emission and detection devices 4, which are symmetrically distributed on both sides of the air bladder 3. The near-infrared spectral emission and detection devices 4 are connected to the monitor body 1 via wires 5, and the monitoring data can be displayed on the screen of the monitor body 1. The air bladder 3 is connected to an inflation tube 6, and the other end of the inflation tube 6 is connected to a... An inflation device, which is a syringe, can inject a fixed amount of gas into the airbag 3 to inflate it. A partition 7 is fixedly installed inside the catheter 2, which divides the inside of the catheter 2 into a first tube 8 and a second tube 9. The first tube 8 includes two sub-tubes through which the wire 5 and the inflation tube 6 pass. The end of the first tube 8 near the airbag 3 is sealed. The second tube 9 is used for the input of nutrient solution. A guide wire is installed inside the second tube 9 to facilitate the placement of the intestinal tube. Once the intestinal tube is in place, the guide wire is withdrawn to provide force support and improve the success rate of catheter 2 placement. The guide wire can reach the jejunum.

[0024] The near-infrared spectral emission and detection device 4 includes a single-beam near-infrared spectral emission end and a receiving end sensing electrode; the single-beam near-infrared spectral emission end and the receiving end sensing electrode are integrated on an electrode sheet; the electrode sheet is installed on the inner wall of the airbag 3 to prevent corrosion by digestive fluid, and the emission wavelength of the single-beam near-infrared spectral emission end is 760nm or 840nm.

[0025] like Figure 4 The diagram shows the intraoperative situation. The device is inserted into the intestinal tract. The area between the two dotted lines is the surgical area to be resected, and the area with two oblique lines is the surgical boundary to be determined. The oxygen saturation of the tissue in this area is detected by using the device. The point with acceptable oxygen saturation is selected as the transection point, and the lesion intestinal tissue is removed.

[0026] This invention can be applied to the following situations:

[0027] 1. Continuously assess changes in small intestinal mucosal microcirculation and tissue oxygen supply and demand. The catheter of this invention is placed in the jejunum, and a finger-clip oxygen saturation monitoring device is connected to the monitor for comparison with tissue oxygen saturation data. When the finger-clip oxygen saturation data is within the normal range, it indicates that the oxygen saturation of the blood oxygenated via the lungs in circulation has reached normal levels, meaning oxygen delivery is within the normal range. If the oxygen saturation in the intestinal mucosa decreases or falls below the lower limit of normal tissue oxygen saturation, it indicates a mismatch between oxygen delivery and consumption in the gastrointestinal tract, i.e., an imbalance between supply and demand. This may be due to a decrease in effective circulating blood volume in the gastrointestinal tract or an increase in gastrointestinal consumption. In such cases, clinicians need to further investigate based on the patient's clinical condition.

[0028] 2. Evaluation of intestinal mucosal microcirculation and oxygen consumption during nutritional support reflects the match between enteral nutrition and current intestinal function, and whether there is an issue of intestinal overload. Based on the above, when the patient's hemodynamics have stabilized, meaning shock from various causes has been corrected, and the patient is not in the acute phase of the disease, the body's condition is relatively stable. At this point, enteral nutrition is often considered clinically. Therefore, it is assumed that the blood supply to the gastrointestinal tract, i.e., the effective circulating blood volume, is not abnormal. However, due to the long-term lack of nutritional therapy, gastrointestinal function is reduced, and the impact of disease or stress can lead to intestinal damage. Therefore, if the oxygen saturation of the intestinal mucosa shows a continuous decreasing trend before and after enteral nutrition, it indicates that the amount of enteral nutrition is not matched with intestinal function, and the rate and amount of enteral nutrition need to be adjusted.

[0029] 3. For high-risk patients in the perioperative period of various gastrointestinal surgeries. Based on the above, these patients, such as those with intestinal diseases requiring surgical treatment like intestinal volvulus, intestinal obstruction, and mesenteric artery embolism, often suffer from abnormal gastrointestinal blood supply, meaning a reduced effective circulating blood volume in the gastrointestinal tract. Therefore, the mucosa of the lesion site often suffers from insufficient oxygen supply, failing to meet the basic oxygen requirements of the tissue, resulting in a hypoxic state and reduced tissue oxygen saturation. Placing a catheter near the intended resection site within the surgical field during surgery and monitoring the oxygen saturation of the surrounding tissue can indicate the presence and quality of blood supply, helping the surgeon determine the length of the intestinal segment to be resected. Additionally, after intestinal anastomosis, for high-risk patients concerned about postoperative anastomotic leakage or intestinal fistula, the catheter can be placed near the anastomosis site. If postoperative recovery is poor, patients often experience severe intestinal wall edema, poor suture healing, and decreased oxygen saturation in the intestinal tissue near the lesion due to edema and poor blood supply. Therefore, continuous monitoring of intestinal oxygen saturation near the anastomosis can serve as a warning, helping surgeons differentiate between postoperative pain in the surgical area and high-risk factors such as anastomotic leakage or poor anastomotic healing, allowing for timely further diagnosis and treatment to avoid delays in treatment. Furthermore, after placement of the catheter under intraoperative anesthesia and once the patient has expelled gas, enteral nutrition can be further administered using this invention, reducing postoperative discomfort associated with the feeding catheter. This is particularly suitable for high-risk patients who still have difficulty resuming normal oral diet postoperatively.

[0030] This specific embodiment is merely an explanation of the present invention and is not intended to limit the invention. After reading this specification, those skilled in the art can make modifications to this embodiment without contributing any inventive step, but such modifications are protected by patent law as long as they are within the scope of the claims of the present invention.

Claims

1. A monitor for monitoring the oxygen saturation of intestinal mucosal tissue, characterized in that, The device includes a monitor body (1) and a conduit (2). One end of the conduit (2) is fitted with an airbag (3). The outer wall of the airbag (3) is fitted with a near-infrared spectral emission and detection device (4). The near-infrared spectral emission and detection device (4) is connected to the monitor body (1) via a wire (5). The airbag (3) is connected to an inflation tube (6). The other end of the inflation tube (6) is fitted with an inflation device. The conduit (2) is fitted with a partition (7). The partition (7) divides the inside of the conduit (2) into a first pipe (8) and a second pipe (9). The first pipe (8) includes two sub-pipes through which the wire (5) and the inflation tube (6) pass, respectively. The end of the first pipe (8) near the airbag (3) is sealed. The second pipe (9) is a nutrient solution delivery pipe. The near-infrared spectral emission and detection device (4) includes a single-beam near-infrared spectral emission end and a receiving end sensing electrode; the single-beam near-infrared spectral emission end and the receiving end sensing electrode are integrated on an electrode sheet, and the electrode sheet is installed on the inner wall of the airbag (3).

2. The intestinal mucosal tissue oxygen saturation monitoring device according to claim 1, characterized in that, The emission wavelength of the single-beam near-infrared spectral emitter is 760 nm or 840 nm.

3. The intestinal mucosal tissue oxygen saturation monitoring device according to claim 1, characterized in that, Two near-infrared spectral emission and detection devices (4) are provided, and the two near-infrared spectral emission and detection devices (4) are symmetrically distributed on both sides of the airbag (3).

4. The intestinal mucosal tissue oxygen saturation monitoring device according to claim 1, characterized in that, The second pipeline (9) is equipped with a guide wire.

Images