TWI519272B - Apparatus and methods for identifying a tissue inside a living body - Google Patents

Description

Device for sensing tissue in living body and method thereof

The present invention relates to a method of testing the material properties of an object, and more particularly to a device and method for sensing the properties of tissue material in a living organism.

Whether the organization in the body is normal is a problem that medical and even biotech workers often face. The prevalence of malignant tumors is increasing year by year, and the mortality rate of cancer caused by cancer is second only to cardiovascular disease. Therefore, early diagnosis and treatment of tumors has become an important issue. In recent years, the development of endoscopes has gradually matured, and its size and function have been greatly improved. Therefore, the use of endoscopes for the diagnosis and treatment of lesions in the human body is becoming more and more important. However, at present, endoscopy can only provide image information on the surface of the tissue, which is not advantageous for early diagnosis of tumors. Therefore, it is often necessary to use endoscopic tissue to slice and then perform pathological judgment in the posterior segment, but this will bear the slice. And the risk of massive internal bleeding. However, if the endoscope can be added to recognize the function of tissue stiffness characteristics, and to infer whether the tissue is normal, it will contribute to the endoscope's information for early tumor diagnosis and the risk of eliminating tissue sectioning. Similarly, devices and methods that can be used to sense tissue in a living body can also be used to observe whether an object implanted in the body (such as a filler for shaping) has a qualitative change in the body, or to observe the development of connective tissue after the lesion is restored. The situation.
It is a major function of the tactile sensor to be able to discern the softness and hardness of the object, especially for distinguishing the different hardness of the animal. At present, tactile sensing devices that are conventionally configured in the endoscope to sense the properties of tissue materials in a living body are not too complicated to use, or are insufficient in function, and it is difficult to distinguish an object whose material properties are similar to those of a living tissue. Please refer to FIG. 1, which is a schematic diagram of an image processing endoscope 10 that can discern tissue stiffness. On top of the conventional endoscope structure 11, the designer adds an outer structure 12 to match a spring 13 and a transparent window 14 and filter element 15 disposed within the spring 13. The axis of the endoscope 10 in the figure is parallel to the Z-axis direction. Fig. 2 shows a cross-sectional view of the portion of the spring 13, i.e., viewed along the axial direction of the endoscope 10. Obviously, such a design can determine the softness and hardness of the object or tissue in front of the endoscope 10 via the force FZ of the spring 13 in the Z direction. However, it ignores the effect of the other two directions shown in Fig. 2. Force Fx and FY. Therefore, the device shown in Fig. 1 has a very limited effect on recognizing the softness and hardness of the object in front, and is also prone to misjudgment.
Some people have proposed ways to distinguish the mechanical properties of objects by the transmission of vibration signals. However, at a lower frequency, it has been found that low-voltage measurements are susceptible to noise and accuracy. There are also material property sensing devices made using other principles, and it is also difficult to distinguish soft objects, such as the difference between sponge and gel samples.
As a result of the job, the inventor, in view of the lack of design of the prior art, was carefully tested and researched, and invented the case, using a measuring material to estimate the material properties of the object to be tested method. The method proposed by the invention only needs to use the measuring material prepared by the simple program as a tool, and by measuring the difference of the stress generated at different mechanical properties, the hardness and hardness of the tested tissue can be instantly and effectively identified, and then Determine whether the malignant tumor is present at the site to be tested. The following is a brief description of the case.

It is a feature of the present invention to provide a method and apparatus for testing the properties of tissue materials. According to the above concept, the present invention provides an in vivo sensing device comprising a manipulation medium, a sensing element and an analysis medium. The sensing component receives manipulation of the manipulation medium to sense a parameter of a tissue; the analysis medium is used to analyze the meaning represented by the parameter.
In accordance with another aspect described above, the present invention provides an in vivo sensing device that includes a tactile sensing element; and a steering medium for manipulating the tactile sensing element.
According to still another aspect described above, the present invention provides a biological sensing method comprising the steps of: (a) providing a pair of phase-acting members; and (b) sensing a parameter of a tissue with the pair of members; And (c) analyze the meaning of the parameter.
The apparatus and method for sensing tissue in vivo according to the present invention described above can be understood by the following general examples and illustrations to gain a deeper understanding of the implementation and advantages of those skilled in the art:

The technical means of the present invention will be described in detail below, and it is believed that the objects, features, and advantages of the present invention will become more apparent and understood. Limit it.
When an object has two parts with significantly different mechanical properties, for example, one left and one right, when the object is subjected to the upward and downward direction, the stress measured from the left and right two different parts will be obvious. Difference, because the hard part will bear more external force. The difference in stress between the two parts changes with the mechanical properties of the material at the end of the force application.
Please refer to FIG. 3A , which is a schematic diagram of an embodiment of a sensing device for estimating the material properties of an object to be tested using a measuring material according to the present invention. As shown, a sensing element 30 has a first surface 311 and a second surface 312. The sensing element 30 is composed of a first portion 321 and a second portion 322, wherein the material properties of the first portion 321 are mechanical. (e.g., the modulus of elasticity) is E1; and the mechanical properties of the material of the second portion 322 (e.g., the modulus of elasticity) is E2, and there is a significant difference between E1 and E2. As can be seen from the figure, the second surface 312 of the sensing element 30 simultaneously includes the surfaces of the first portion 321 and the second portion 322. For convenience of explanation, the first portion 321 and the second portion 322 are sequentially arranged in the horizontal direction, and the first surface 311 and the second surface 312 are the upper surface and the lower surface of the sensing element 30, respectively. The coefficient of elasticity E1 of the first portion 321 is greater than the coefficient of elasticity E2 of the second portion 322. It is not limited to the above-described configuration in practice, and can also lead to the effects expected by the present invention. The modulus of elasticity also reflects the softness and hardness of the material. For the same type of material, its density is also related to the modulus of elasticity or hardness. Therefore, the present invention is also applicable to estimating the material properties of an object to be tested based on the difference in hardness or density of the material.
When a soft tissue is placed at one end of the sensing element 30 near the first surface 311, and an external force F is applied to the upper and lower ends of the sensing element 30, a contact force is generated between the soft tissue and the sensing element 30 to cause deformation. . As shown in the figure, since E1 is larger than E2, that is, the first portion 321 is relatively hard, its shape variable is less than that of the second portion 322; the second portion 322 is softer, so the deformation is stronger after the force is applied. many. At this time, if the stresses of the positions are measured from the second surface 312 with respect to the position 331 below the first portion 321 and the position 332 below the second portion 322, respectively, according to the material mechanics principle previously described, Get different values. The present invention utilizes a simple manner of placing piezoelectric material (not shown) below the second surface 312 to read voltage values V1 and V2 from two locations, 331 and 332, respectively. In general, the voltage generated by the piezoelectric material at the same thickness is proportional to the compressive stress received. Therefore, the ratio of the stress at the two positions of 331 and 332 can be known from the ratio of the voltage values V1 and V2.
The rightmost side of Fig. 3A shows voltage values V1 and V2 taken from different positions below the first portion 321 and the second portion 322, respectively, in which the V1 value is indicated by a broken line and the V2 value is indicated by a solid line. The horizontal axis shows the distance between the two sampling positions. The test results show that the dotted line representing the voltage value V1 is above the solid line representing the voltage value V2, in accordance with the aforementioned theory.
Referring to Figure 3B, the sensing element 30 is shown to be identical to Figure 3A, while Figure 3B is for measuring a harder tissue. As shown, the harder tissue is placed at one end of the sensing element 30 near the first surface 311 while simultaneously applying an external force F to the upper and lower ends of the sensing element 30 to create a relationship between the harder tissue and the sensing element 30. Contact force causes deformation. However, due to the higher elastic modulus value or hardness of the harder tissue, the degree of deformation generated is far less than that caused by the same contact force between the soft tissue and the sensing element 30 in FIG. 3A. With the voltage values read by the same configuration (as shown on the right side of Figure 3B), it can be found that the difference between the voltage values V1 and V2 is significantly larger. Comparing the difference between the 3A and 3B, it can be known that the ratio between the voltage values V1 and V2, or the stress ratio reflected by it, can be used to estimate the properties of the material to be tested and soft and hard. , for example, modulus of elasticity or hardness. For example, when the ratio between the measured voltage values V1 and V2 is high, it can be known that the hardness of the tissue to be tested is high, and the two data exhibit a positive correlation.
Referring to Figure 4, there is shown a preferred embodiment of a sensing element in accordance with the present invention which is capable of measuring the material properties of tissue in vivo using the methods described above. 4 shows that the sensing element 40 has two flexible substrates 41, wherein a first electrode 421 and a second electrode 422 are disposed above one of the substrates 41, and a third electrode 423 is disposed at a relative position on the other of the flexible substrates 41. And a fourth electrode 424. Between the above four electrodes, a sensing function element 441, usually a PVDF material sheet, is a piezoelectric material.
Referring to FIG. 4 , the first electrode 421 and the third electrode 423 form a pair of electrodes, and the voltage signal (not shown) generated by the sensing element 441 at the location of the sensing element 441 can be transmitted through the upper and lower softness. The substrate 41 is transferred. Similarly, the second electrode 422 and the fourth electrode 424 also form a pair of electrodes, and the voltage signal (not shown) generated by the sensing element 441 at the location where it is subjected to the compressive stress is transmitted through the upper and lower flexible substrates 41. Pass it out. In this embodiment, the electrodes are placed in advance on the flexible substrate, and the electrodes are placed on the upper and lower surfaces of the sensing element 441 by the flexible substrate. Then, the circuit inside the flexible substrate can provide a function of conducting the voltage signal on the electrodes. In other embodiments, the user can directly arrange each set of electrodes in the other manner on the upper and lower surfaces of the sensing element 441, and use other methods to read the voltage measured by the electrodes.
The sensing element 40 is disposed above the second electrode 422 with an elastic object 45, such as an object made of an elastic material such as silicone rubber, latex, or rubber. Finally, the entire structure is packaged into the sensing element 40 using a packaging material 46 that is different in material from the elastic object 45. The method of encapsulating the encapsulating material 46 over the entire structure may be selected by a conventional encapsulant coating process, which is formed by solidifying a gel-like encapsulating material 46 after completely covering the entire structure. As is apparent from the figure, due to the presence of the elastic object 45, the elastic modulus of the formed elastic material above the first electrode 421 and the third electrode 423 is inevitably elastic with the upper portion of the second electrode 422 and the fourth electrode 424. The coefficients are different. Therefore, the sensing element 40 shown in FIG. 4 is suitable for the method described in the preceding paragraph to estimate the material properties of the tissue to be tested.
In the field of material mechanics, parameters commonly used to identify the mechanical properties of materials are Modulus of Elasticity, hardness or density, and so on. The so-called Young's Modulus refers to a relationship between tensile stress and elongation, and also belongs to a commonly used elastic coefficient; and the conventional hardness parameters are Rockwell hardness and Shore. Hardness, etc., the latter is often used to show the hardness of softer elastic materials such as rubber, latex, and resin. Usually, these softer materials have hardness similar to that in general living organisms.
Referring to Fig. 5, there is shown a graph of the relationship between the voltage ratio and the Shore factor after testing three different analytes whose Shore coefficients are known in accordance with the apparatus and method described above. The sample code shown in the figure is a rubber elastomer of the PDMS series produced by Dow Corning. The Shore hardness is known from the product specifications provided by Dow Corning. It can be seen from Fig. 5 that the two sets of data on the horizontal axis and the vertical axis show a significant positive correlation and a one-to-one correspondence. Therefore, the Shore ratio can be estimated from the voltage ratio data measured by the sensing device 40. The hardness of the material to be tested shown in the figure is small, and it is also a relatively soft material, which is close to the hardness of the tissues in general organisms. Generally, the diseased tissue (for example, a malignant tumor) in the tissue in the body is harder than the tissue in the normal state, and the sensing device 40 proposed by the present invention can instantly distinguish the material properties of the tissue, such as the degree of softness and hardness, thereby assisting the medical professional. The person judges whether the sensed part is a malignant tumor or a special type of tissue.
Referring to Figure 6, a schematic cross-sectional view of a typical medical endoscope is shown. The figure shows that the structure of the endoscope 60 includes an instrument channel 61, a light guide 62, an objective lens 63, and a water/air nozzle 64. The present invention provides a simple way to mount a tactile sensing element (such as the sensing element 40 described above) having a function of distinguishing the degree of softness and softness of the tissue to the medical endoscope 60 to increase the feedback of the tactile perception information. Endoscopic surgery. Generally, the instrument channel 61 of the medical endoscope has a size of about 6 mm to 1 mm. Therefore, the present invention proposes a manipulation medium in the form of a camera, and the sensing element is mounted on the surface of the grip port of the manipulation medium, and the sensing is performed via the instrument channel. The device is sent to the human body for testing. The measurement method is basically to grasp the tissue to obtain the information of its material properties.
Please refer to Figures 7A-7C for a preferred embodiment of the control medium proposed by the present invention for manipulating the sensing elements. The control medium 70 in FIG. 7A is disposed in the structure of the endoscope 60, and can be matched with the original function of the endoscope 60, so that the user can observe the tissue in the body by using the endoscope 60, and select the part to be sensed for testing. . The control medium 70 has a mechanism such as a camera or a clip, wherein the link 71 is provided with a tactile sensing element 711, which can be manipulated by the manipulation medium 70 to sense parameters of the tissue in the living body, such as elastic coefficient or soft and hard. degree. The parameter information collected by the tactile sensing component 711 can be further analyzed by an analysis medium (as shown in FIG. 8) to analyze the meaning represented by the parameter. For example, by comparing known data records, it can be determined whether the tissue to be tested is a normal tissue or a diseased tissue such as a tumor.
Referring to FIG. 7B, the steering medium 70 has a link structure in which the first link 71 and the second link 72 are provided with tactile sensing elements 711 and 721. Through the operation mechanism of the link, the third link 73 and the fourth link 74 of the manipulation medium 70 respectively control the moving directions of the first link 71 and the second link 72.
Fig. 7C shows that when the first link 71 and the second link 72 are utilized to sandwich the portion to be tested of the tissue in the living body, the tactile sensing elements 711 and 721 on the first link 71 and the second link 72 are The figure is configured as an opposite position and can simultaneously contact the same tissue site. In particular, the manner of manipulating the first link 71 and the second link 72 is not limited to the link mechanism shown in FIG. 7B. A person skilled in the art can use a number of other ways to manipulate the first link 71 and the second link 72, and no further details are provided herein. In addition, in order to be able to sense the parameters of the tissue in the living body, such as the elastic coefficient or the degree of softness and hardness, the embodiment only needs to configure one of the tactile sensing elements 711 and 721 to obtain the desired efficacy. Simultaneous use of sensing elements 711 and 721 helps to sense parameters at different locations in the same tissue and multiplies the efficiency of the detection.
In order to provide the user with convenient operation and to instantly distinguish the characteristics of the detected target tissue, the present invention provides a modular system for analyzing the meaning represented by the parameter. As shown in FIG. 8, the present embodiment uses distributed microelectronic element to capture the inner structure of the sensing element output signal outer coating material (piezoelectric respectively group 1 signal V ₁ and the second group of piezoelectric The signal V _{2 is} indicated), so when the sensing component triggers the detection of the object, the two sets of signals are respectively amplified by the amplifiers 811 and 812 in the control module 81, then enter the microcontroller 813 for processing and calculate the material according to the voltage ratio. The relative relationship between the nature, material properties and voltage ratio data has been previously stored in the database 8132 in the microcontroller 813 for verification or calculation. Finally, the material property related results determined by the material are output to the LCD screen 82. As shown in Figure 5, the relative relationship between the material properties and the voltage ratio is based on the Shore hardness coefficient. Those skilled in the art may also use other material properties, such as the modulus of elasticity or other hardness factors. The calculated parameters represent the meaning.
Example
1. An in vivo sensing device comprising:
a manipulation medium;
a sensing component that accepts manipulation of the manipulation medium to sense a parameter of an organization; and an analysis medium to analyze the meaning represented by the parameter.
2. The device of embodiment 1, wherein the sensing element comprises:
a pressure sensitive element having a first surface and a second surface;
a first electrode and a second electrode are respectively disposed on the first surface;
a third electrode disposed on the second surface and corresponding to the first electrode;
a fourth electrode disposed on the second surface and corresponding to the second electrode; and an elastic object disposed on the first surface, wherein the elastic object has a first portion and a first portion having different elastic coefficients a second portion, and the first portion covers the first electrode and the second portion covers the second electrode.
3. The device according to embodiment 1, further comprising:
An endoscope instrument channel; and a link mechanism disposed in the channel of the endoscope instrument, wherein the link mechanism has a first link and a second link corresponding to each other, and the sensing component Disposed on the first link.
4. The device according to embodiment 3, further comprising:
A second sensing element is disposed at a position of the second link toward the sensing element on the first link.
5. An in vivo sensing device comprising:
a tactile sensing element; and a manipulation medium for manipulating the tactile sensing element.
6. The device of embodiment 5 wherein the tactile sensing element comprises:
a pressure sensitive element having a first surface and a second surface;
a first electrode and a second electrode are respectively disposed on the first surface;
a third electrode disposed on the second surface and corresponding to the first electrode;
a fourth electrode disposed on the second surface and corresponding to the second electrode; and an elastic object disposed on the first surface, wherein the elastic object has a first portion and a first portion having different elastic coefficients a second portion, and the first portion covers the first electrode and the second portion covers the second electrode.
7. The device according to embodiment 5, further comprising:
An endoscope instrument channel; and a link mechanism disposed within the channel of the endoscope instrument, wherein the link mechanism has a first link and a second link corresponding to each other, and the tactile sensing The component is disposed on the first link.

8. The device according to embodiment 7, wherein the link mechanism is a link set, the link set includes a third link and a fourth link, and the third and the fourth link are respectively controlled The first and the second link.
9. A method of sensing a living organism comprising:
Providing a pair of pivoting action members;
Sensing a parameter of a tissue with the pair of acting members; and analyzing the meaning represented by the parameter.
10. The method of embodiment 9, wherein the pair of phase pivoting active members comprise a corresponding first link and a second link, the method further comprising:
Configuring a tactile sensing element over the first link;

Using the first link and the second link, the tactile sensing element is brought into contact with the tissue to obtain the parameter, wherein the parameter is a modulus of elasticity, a hardness, or a density.
The invention provides a method and a device for measuring the properties of tissue materials in a living body, which can instantly distinguish the material properties of the tissue in the body or the implanted object; however, according to the basic theory of material mechanics, it can be inferred that the appropriate amount of soft and hard is selected. The present invention can also be applied to distinguish the properties of materials such as hard metal materials. The present invention can provide high reliability test data.
While the invention has been described above in terms of several preferred embodiments, it is not intended to limit the invention, and the invention may be modified and modified without departing from the spirit and scope of the invention. The scope of the invention is defined by the scope of the appended claims.

10. . . Sensed endoscope

11. . . Traditional endoscope structure

12. . . Outer structure

13. . . spring

14. . . Transparent window

15,25. . . Filter element

30. . . Measuring material

311. . . First surface and

312. . . Second surface

321. . . first part

322. . . Second part

331, 332. . . Measuring position

40. . . Sensing device

41. . . Flexible substrate

421. . . First electrode

422. . . Second electrode

423. . . Third electrode

424. . . Fourth electrode

441. . . Sensing element

45. . . Elastic object

46. . . Packaging material

60. . . Endoscope

61. . . Instrument channel

62. . . Light guide

63. . . Objective lens

64. . . Water/air nozzle

70. . . Control medium

71, 72, 73, 74. . . link

711, 721. . . Sensing element

81. . . Control module

811, 812. . . Amplifier

813. . . Microcontroller

8131. . . 10 bit A/D converter

8132. . . database

82. . . Screen

83. . . power supply

84. . . Power conditioner

Figure 1: Schematic diagram of an image processing endoscope that can be used to discern tissue hardness.
Figure 2: A cross-sectional view of the endoscope shown in Figure 1.
3A and 3B are views showing an embodiment of a sensing device proposed by the present invention.
Figure 4: A preferred embodiment of a sensing device in accordance with the present invention.
Figure 5 is a diagram showing the relationship between the voltage ratio and the Shore A coefficient of a sensing device and a method thereof according to the present invention after testing different objects to be tested.
Figure 6: Schematic cross-section of a conventional medical endoscope.
7A-7C are schematic views of an embodiment of a steering medium for manipulating a sensing element in accordance with the present invention.
Figure 8 is a schematic illustration of an embodiment of a modular system for analyzing parameters in accordance with the present invention.

60. . . Endoscope

70. . . Control medium

71. . . link

711. . . Sensing element

Claims (7)

An in vivo sensing device includes: a manipulation medium; a sensing component that receives manipulation of the manipulation medium to sense a parameter of a tissue, wherein the sensing component comprises: a piezoelectric component having an upper a first flexible substrate disposed on the upper surface of the piezoelectric element and having a first surface facing the upper surface and a second surface opposite to the first surface a first electrode of the first surface, and a second electrode formed on the first surface, wherein the first electrode and the second electrode are electrically connected to the piezoelectric element; and a second flexible substrate is disposed at the pressure The lower surface of the electrical component has a third surface facing the lower surface, a third electrode formed on the third surface, and a fourth electrode formed on the third surface, wherein the third electrode Corresponding to the first electrode, the fourth electrode corresponds to the second electrode, and the third electrode and the fourth electrode are electrically connected to the piezoelectric element; an elastic body is disposed on the first flexible substrate On the second surface a position corresponding to the second electrode and the fourth electrode; and a packaging material having a material different from the elastic body, and covering the piezoelectric element, the first flexible substrate, the second flexible substrate, and the elastic body And an analysis medium to analyze the meaning of the parameter. The device of claim 1, further comprising: an endoscope instrument channel; and a link mechanism disposed in the endoscope instrument channel, wherein the link mechanism has a corresponding one a link and a second link, and the sensing element is disposed on the first link. The device of claim 2, further comprising: a second sensing element disposed at a position of the second link toward the sensing element on the first link. An in-vivo sensing device comprising: a tactile sensing component, comprising: a piezoelectric element having an upper surface and a lower surface; a first flexible substrate disposed on the upper surface of the piezoelectric element and having a a first surface facing the upper surface, a second surface opposite to the first surface, a first electrode formed on the first surface, and a second electrode formed on the first surface, wherein the first The electrode and the second electrode are electrically connected to the piezoelectric element; a second flexible substrate is disposed on the lower surface of the piezoelectric element, and has a third surface facing the lower surface, and is formed on the third surface a third electrode of the surface, and a fourth electrode formed on the third surface, wherein the third electrode corresponds to the first electrode, the fourth electrode corresponds to the second electrode, and the third electrode and The fourth electrode is electrically connected to the piezoelectric element; an elastic body disposed on the second surface of the first flexible substrate at a position corresponding to the second electrode and the fourth electrode; and a packaging material, Has no phase with the elastomer The material and covering the piezoelectric element, the first flexible substrate, the flexible substrate and the second elastic member; and a control medium, for control of the tactile sensing element. The device of claim 4, further comprising: an endoscope instrument channel; and a link mechanism disposed in the endoscope instrument channel, wherein the link mechanism has a corresponding one a link and a second link, and the tactile sensing element is disposed on the first link. The device of claim 5, wherein the link mechanism is a link set, the link set includes a third link and a fourth link, and the third and the fourth link respectively The first and second links are manipulated. A method of manufacturing a sensing element, comprising the steps of: providing a piezoelectric element having an upper surface and a lower surface; providing a first flexible substrate, the first flexible substrate having a first surface facing the upper surface a surface, a second surface opposite to the first surface, a first electrode formed on the first surface, and a second electrode formed on the first surface; providing a second flexible substrate, the second The flexible substrate has a third surface facing the lower surface, a third electrode formed on the third surface, and a fourth electrode formed on the third surface, wherein the third electrode corresponds to the first electrode And the fourth electrode corresponds to the second electrode; the first flexible substrate is bonded to the upper surface of the piezoelectric element, and the first electrode and the second electrode are electrically connected to the piezoelectric element; The second flexible substrate is bonded to the lower surface of the piezoelectric element to electrically connect the third electrode and the fourth electrode to the piezoelectric element; and an elastic body is disposed on the second surface of the first flexible substrate And the second electrode a position corresponding to the fourth electrode; and coating the piezoelectric element, the first flexible substrate, the second flexible substrate, and the elastic body with an encapsulating material, wherein the encapsulating material has a different color from the elastic body Material.