TW201601781A - A method of tissue identification using disposable fiber opticial needle for medical device placement - Google Patents

Abstract

The creation provides an effective positioning anesthetic needle or auxiliary Minimally Invasive Surgery. This is an objective identification of ways to help physicians more accurately judge the success puncture, avoid postoperative headache, bleeding or perforation and other complications. In this study, we present a novel epidural needle that allows for the acquisition of optical reflectance spectra from tissue close to the beveled surface. This needle has optical fibers embedded in the cannula that deliver and receive light. With wide spectrometer, light received from tissue is resolved to determine the feasibility of optical tissue differentiation, spectra were acquired from porcine tissues. The creation uses a optical fibe needle in place of a traditional novel epidural inner needle, the fiber ends are connected to a light source and a detector to detect the optical characteristics of the organization's interpretation, provide users with a more objective data. The results of this study suggest that the optical fiber needle has potential to improve the accuracy of epidural space identification and abdominocentesis.

Description

Method for medical use disposable positioning needle using optical tissue identification

[1] The present invention can be applied to minimally invasive surgery, spinal anesthesia for anesthesia, tissue identification, clinical operations such as postoperative analgesia or painless delivery, and identification of intestinal adhesion during abdominal surgery.

[2] The main concept of the present invention is to utilize the difference in composition of various tissues of the living body. Each tissue has different absorption and reflection of light of different wavelengths and optical characteristics of Raman fluorescence, so that light sources of several different wavelength bands are used. Projected on the biological tissue through the optical fiber to discriminate the optical characteristics of the tissue to identify the tissue in which the needle is inserted or to accurately target the surface of the biological tissue or organ for specific positioning purposes, and then perform specific treatment or surgery. [3] This technology can use a specific light source to illuminate the tissue, identify the blood oxygen level of the tissue, or bio-fluorescence, to achieve the identification of bad tissue, and to improve the effect of self-treatment. [4] (Example 1) In the case of minimally invasive abdominal surgery, the majority of middle-aged women have intestinal adhesion. Before the minimally invasive surgery, a hole must be inflated in the abdomen to make the abdomen inflated. If the doctor's first hole is in the intestines, the intestines will be damaged and the minimally invasive surgery will fail. The patient must immediately open a large knife in the abdomen. This is what the doctor expects. If the doctor uses my new Technology, when you first use this technology when you first drill the air hole, you can immediately find that the signal is wrong during the puncture process, and the tissue is sticky. The replacement of the piercing position avoids the risk of minimally invasive surgery failure. [5] (Example 2) In the emergency and emergency treatment, the doctor often can not find the superficial blood vessels of the patient. Using this technique, the optical signal difference between the vascular cavity, the blood vessel wall and the muscle tissue can be quickly distinguished. The correct position of the blood vessel. [6] This patent uses dura mater anesthesia as a practical case: epidural anesthesia is to inject a local anesthetic into the epidural space and reversibly block the spinal nerve to obtain anesthesia. The method of effect, also known as the epidural block, is one of the half-body anesthesia methods commonly used in surgery. For anesthesiologists, the most critical issue in performing this anesthesia is to accurately identify the location of the epidural space. First, from the point of view of anatomy and physiology, as shown in Figure 1, the epidural space is a potential cavity between the dural mater and the ligamentum flavum, which is extremely narrow. The cavity also causes difficulty in detecting and locating the anesthesia. The cavity has different widths depending on the size and age of the person. Normally, it is the widest in the middle of the waist, and its width is 3~6mm, and only 1~5mm in the middle chest. If you accidentally wear the dura mater, it will cause sequelae such as post-dural puncture headache (PDPH), and the risk of damage to the spinal cord. Therefore, the importance of correct puncture can be known. Because it is currently clinically necessary to rely on anesthesiologists through years of experience and technology to determine whether the needle reaches the epidural space. Traditionally, the most important method of identification is the physician's feel to feel the resistance of the ligamentum flavum as the first important indicator, and the resistance of the ligamentum flavum varies with age, gender and body type. For example, the aged ligament of the elderly is less elastic. Pregnant women or obese people who are not exercising often may have less resistance to the ligamentum flavum. If the hand of the anesthesiologist at the time is not in good condition, so that the doctor is not easy to feel and judge, it is possible to wear a dura mater and make a mistake, resulting in a patient with a postoperative headache and other sequelae. Therefore, the present invention is intended to provide an effective auxiliary detecting device capable of providing an objective and scientific auxiliary judgment basis, and helping an anesthesiologist to perform an epidural anesthesia in addition to subjective experience and technology. Other more objective criteria and evidence to increase the correctness of the secondary physician's detection.

[7] Because the current practice of performing dural anesthesia in the clinic can only rely on the experience and technique of the anesthesiologist to determine whether the needle reaches the epidural space, it is very lack of objectivity. Therefore, the inventor can conveniently use one. Quantitative Judgment Criteria—Detects the optical properties of biological tissue and quantifies the values of light refraction and reflection from the tissue itself. This greatly improves the accuracy of performing this anesthesia and reduces the risk of surgery. [8] The present invention relates to an injection kit that provides a needle positioning function for locating a needle by identifying different density and resistance characteristics of an individual tissue, including: (a) a removable optical identification needle, the interior thereof Containing two or more optical fibers, respectively connected to the light source and the optical detector, the sub-needle shall be placed in the anesthesia puncture needle; (b) a connecting fiber optic wire for connecting the fiber sub-needle and the detector; (c) A light source for providing light source for tissue identification; (D) a detector for detecting the resistance characteristics of individual tissues. [9] The removable optical identification needle in the injection kit of the present invention has a tail end comprising a fiber optic connector, and the connector allows the optical identification needle to be quickly connected to the light source and the needle detector. Light from the light source is transmitted to the tissue that the tip of the sub-needle is pierced, and the reflected light of the tissue is transmitted to the light detector. If the number of the fibers is greater than one, a part of the fibers can be designed as an introduction path for incident light, and the other portion is designed as a path for the reflection of light. [10] Because different tissues exhibit different optical properties due to their different compositions, for example, muscle tissue and fat tissue have different compositions, and different tissues may differ, such as excitation fluorescence values and The reflected light value will be different at different incident light wavelengths. Therefore, the light detector in the injection kit of the present invention uses this principle to detect reflected light or excited fluorescence values of individual tissues at different wavelengths. Information is provided to provide an indication of the location of the aforementioned thimble and sub-needle tip. Further, if the injection kit is to be applied to the epidural anesthesia, it is found according to the actual research of the inventors. [11] The detector in the present invention can be set by the user to actively send an in-position signal to the connected alarm when the optical identification needle reaches a specific tissue, so that the warning device can flash or sing. To inform the user. [12] The replacement needle in the injection kit of the present invention can be withdrawn when it reaches the target tissue, and is replaced by an injection catheter, and then after the injection catheter is smoothly carried along the female needle into the subject. The female needle is also removed to complete the placement of the injection catheter. The aforementioned injection catheter is a general injection catheter, and a foreign substance such as an anesthetic or a physiological saline solution can be injected into a subject. [13] The present invention also provides a method for identifying a puncture needle by utilizing different optical characteristics of an individual tissue, comprising: (a) inserting a vacuum-receiving optical identification needle containing an optical fiber into a hollow anesthesia puncture needle, and combining the puncture set a group (b) connecting the optical fiber to a light source and a light detector that detects optical characteristics of the individual tissue to provide information on the tissue aspect; and (c) the aforementioned puncturing set The individual is inserted and the position of the tip of the piercing set is reached by the tissue information provided by the light detector. [14] In the method for positioning the injection needle, the optical characteristic detected by the optical detector is the reflected light value or the fluorescence value of the substance at different wavelengths, and the user can set the optical detector by himself. When it is judged that the puncturing set reaches the target tissue, the user can be informed by sound and light signals or other warning means. At this time, the user can take out the removable optical identification needle containing the optical fiber and replace it with an injection catheter, and then withdraw the anesthesia puncture needle, so that the injection catheter can be accurately placed on the injection catheter. A specific location within the subject. Moreover, the method can also be practiced with the various components disclosed in the foregoing set. [15] The present invention has been described in detail, and there are obvious examples, and anyone skilled in the art can use it and make various substitutions, modifications or improvements, but obviously, these cannot be combined with The spirit and scope of the invention are separated. [16] A person skilled in the art will readily appreciate that the present invention can easily achieve the objectives and achieve the results and advantages mentioned, as well as those that are present therein. Detection of the spinal epidural space by the resistance vibration detection method is representative of a preferred embodiment, which is exemplary and not limited to the field of the invention. Those skilled in the art will be aware of the modifications and other uses therein. These modifications are intended to be within the spirit of the invention and are defined in the scope of the claims. It is apparent to those skilled in the art that the invention disclosed herein may be variously substituted and changed without departing from the scope and spirit of the invention. [18] All patents and publications mentioned in the specification are subject to the general skill of the art in the field of the invention. All patents and publications are hereby incorporated by reference to the same extent as if the individual publications that are specifically and individually indicated are incorporated by reference. [19] The invention suitably exemplified herein may be practiced in the absence of any element, or a plurality of elements, limitations, or limitations. Thus, for example, in each instance of this document, the terms "including", "including" and "containing" are used, and any one of them can be replaced by the other two. The nouns and expressions used are as a description and not a limitation of the description, and are not intended to use any such nouns and expressions except those which are equivalent to those illustrated or illustrated, but The change is possible within the scope of the patent application of the present invention. Therefore, it is to be understood that the present invention has been disclosed and described herein in accordance with the preferred embodiments and the features of the present invention. Within the scope.

[24] The following examples illustrate the invention. They are intended to illustrate the invention and to illustrate various advantages of the specific embodiments of the invention, but are not intended to [25] The present invention is applied to the concept of epidural anesthesia: different tissues exhibit different optical characteristics due to their different compositions, such as fluorescence values and reflected light values at different incident light wavelengths. It will be different, so the inventors also used this principle to combine traditional epidural anesthesia with optical detection to improve the accuracy of performing this anesthesia. [26] Figure 1 is a schematic longitudinal section of the human back ridge. The vertebrae are not drawn, but the anatomically relative positions of the relevant tissues are shown in English letters. Needles for anesthesia in the epidural space are indicated by blue sharp cones. Periosteum membrane is the periosteum of the vertebrae that is not necessarily encountered during needle advancement. [27] Example 1: Injecting a kit for detecting a tissue pattern using a difference in tissue optical characteristics: [28] In the injection kit of the present invention, the optical identification needle of the present invention can be placed into a puncture needle, and the needle tip is inserted It can be inserted into biological tissues such as skin, muscle, fat or mucous membranes. The optical identification pin is also a hollow design, but the center is placed in the fiber, and the optical fiber is glued to the identification pin at the tip of the identification pin, and the needle is shaped to fit into the shape of the female pin. The fiber is then connected to the connector inside the grip. [2] FIG. 2 is a schematic diagram of the detection mode of the present invention. The light emitted by the light source 201 is guided by the optical wire 202 into the optical fiber in the identification pin, and is focused on the tissue 208 through the objective lens 203 of the identification needle tip. The light that reflects or excites the fluorescent light can be returned to the optical detector 205 by the original path 204, and then the optical detector transmits the detected signal to the computer 206 for dataization, and the display screen 207 provides the organization signal to The user is the basis for judgment. [30] Embodiment 2: Design of Optical Detector [31] Figure 4 is a detection system that integrates the above conclusions into a photovoltaic element to achieve our goal. [32] The control circuit 401 in FIG. 4 is a modulated pulse output that can control two sets of lasers to be mutually inverted, that is, when the A laser light source 402 is turned on, the B laser light source 403 is turned off, and vice versa. . The two sets of laser light are emitted via the splitter 404. Light passes through the optical tape recorder 405 through the fiber coupler 409 into the tissue sample 410, which is reflected or excited and then folded back to the optical splitter 405 along the path. The signal is sent to the photodetector 406, and the photoelectric signal is transmitted to the analyzing circuit 407. Then, it is sent to the control circuit 401 for related signal processing, and finally displayed on the signal display 408 in the ratio of the reflected value or the fluorescent value. [33] The present invention has been described in detail, and there are obvious examples, and anyone skilled in the art can use it and make various substitutions, modifications or improvements, but obviously, these cannot be The spirit and scope of the invention are separated. [34] A person skilled in the art will readily appreciate that the present invention can easily achieve the objectives and achieve the results and advantages mentioned, as well as those that are present therein. Detection of the spinal epidural space by fiber optics is representative of the preferred embodiment, which is exemplary and not limited to the field of the invention. Those skilled in the art will be aware of the modifications and other uses therein. These modifications are intended to be within the spirit of the invention and are defined in the scope of the claims. It is obvious to those skilled in the art that the invention disclosed herein may be variously substituted and changed without departing from the scope and spirit of the invention. [36] All patents and publications mentioned in the specification are subject to the general skill of the art in the field of the invention. All patents and publications are hereby incorporated by reference to the same extent as if the individual publications that are specifically and individually indicated are incorporated by reference. [37] The invention suitably exemplified herein may be practiced in the absence of any element, or a plurality of elements, limitations, or limitations that are not specifically disclosed herein. Thus, for example, in each instance of this document, the terms "including", "including" and "containing" are used, and any one of them can be replaced by the other two. The nouns and expressions used are as a description and not a limitation of the description, and are not intended to use any such nouns and expressions except those which are equivalent to those illustrated or illustrated, but The change is possible within the scope of the patent application of the present invention. Therefore, it is to be understood that the present invention has been disclosed and described herein in accordance with the preferred embodiments and the features of the present invention. Within the scope

[38] 101‧‧‧Detecting needles[39] 102‧‧‧Puncture thimbles and fiber-optic wire connectors [40] 201‧‧‧Light source [41] 202‧‧‧Light guides [42] 203‧‧‧Injection Light Pathway [43] 204‧‧‧Reflective Light Path [44] 205‧‧•Photoelectric Converter [45] 206‧‧‧Signal Processor [46] 207‧‧‧ Display Screen [47] 208‧‧‧ Tested Organization [48] 401‧‧‧Control Circuit [49] 402‧‧‧Light source one [50] 403‧‧‧Light source two [51] 404‧‧ ‧ split optical path one [52] 405‧‧ ‧ split optical path two [53] 406‧‧‧Photodetector [54] 407‧‧‧Signal Processor [55] 408‧‧‧ Display [56] 409‧‧‧Fiber Needle Coupler [57] 410‧‧‧ Samples to be tested

[20] Figure 1. Schematic diagram of the longitudinal section of the human posterior (A: dura Dura; B: Epidural space; C: Ligament flavum; D: Periosteum membrane; E Muscle Muscle; F: Fat Fat; G: Skin Skin). [21] Figure 2. Schematic diagram of the structure of the optical probe. [22] Figure 3. Schematic diagram of the fiber detection method. [23] Figure 4. Schematic diagram of the operation circuit of the optical detector of the present invention.

[58]

101‧‧‧ optical identification needle

102‧‧‧light needle coupler

Claims (7)

An injection kit comprising: (a) an optical probe needle having one or more optical fibers in a central bore; and (b) a built-in fiber optic splice connection to secure the fiber optic needle grip. (c) A fiber optic connection lead for connecting the optical probe to the detector. (d) An optical detector containing a laser source and a photodetector. According to the kit of claim 1, further comprising: (a) a light detector for detecting optical characteristics of the individual tissue; and (b) a light source for providing the aforementioned light detector The incident light source; the light detector and the light source are connected to the optical fiber in the aforementioned needle. According to the kit of claim 1, wherein the optical detector detects the spectral characteristic ratio of the individual tissue at different wavelengths to provide information on the tissue aspect to assist in positioning the aforementioned needle tip. According to the kit of claim 1, wherein the light source is capable of providing one or two or more different wavelengths of light. According to the kit of claim 1, wherein the light source can be a laser light source, an LED light source or a white light source. The method according to claim 1, wherein the optical property refers to a ratio of reflected or excited fluorescence of the substance at different wavelengths. According to the method of claim 1, the method is applied to a specific position such as a human body, an animal, a living body, or a cell, or a tissue identification application.