WO2020040492A1

WO2020040492A1 - Method for measuring bending deformation and stiffness of multi-segmented catheter using nonlinear deformation analysis, and device for measuring bending deformation and stiffness of catheter using same

Info

Publication number: WO2020040492A1
Application number: PCT/KR2019/010457
Authority: WO
Inventors: 류재준; 안효영; 윤대중; 안중환; 김화영
Original assignee: 부산대학교병원
Priority date: 2018-08-23
Filing date: 2019-08-19
Publication date: 2020-02-27
Also published as: KR20200022666A; KR102105248B1

Abstract

The present invention relates to a method for measuring the bending deformation and stiffness of a multi-segmented catheter, and a device for measuring the bending deformation and stiffness of the catheter using same, the method enabling a standard method to be presented whereby, by using a nonlinear deformation equation, the deformation of a catheter may be accurately predicted, and the stiffness of the catheter against nonlinear deformation may be measured. According to the characteristics of the present invention in order to achieve the above purpose, the device for measuring the bending deformation and stiffness of the multi-segmented catheter using a nonlinear deformation analysis comprises: a wire fixing part (30) for fixing an end portion of a wire (140); a sensor part (20) having a sensor for measuring the tension of the wire (140) fixed to the wire fixing part (30); a catheter fixing part (40) for fixing a mounted catheter tube (100); a bottom part (50) for fixing the catheter fixing part (40); a bottom control part (60) having a micro-feeding apparatus so as to enable the bottom part (50) to be transferred; graph paper (70) for measuring a deformation curve by the deformation of the catheter tube (100); and a support part (10) for supporting the sensor part (20) and the bottom part (50), wherein bending deformation is formed by the tension, acting on the wire (140), being transferred to the catheter tube (100).

Description

Method for measuring bending deformation and stiffness of multi-segment catheter using nonlinear deformation analysis and measuring device for bending deformation and stiffness using same

The present invention provides a method of measuring bending and stiffness of a multi-segment catheter that accurately predicts the deformation of the catheter using a nonlinear deformation equation and provides a standard method for measuring the stiffness against the nonlinear deformation of the catheter, and the catheter bending deformation using the same and Stiffness measurement apparatus

The catheter is introduced into blood vessels and organs for intravascular diagnosis, treatment, and delivery of medical device structures. Currently, the catheter tube has a problem that it is difficult to precisely control because the direction of deformation is not constant. In order to accurately position the catheter tip to the required position in the pleura, it is very important to measure the catheter's bending deformation and its rigidity according to the bending deformation.

Without knowing the exact stiffness values of each segment constituting the catheter, it is impossible to accurately predict the catheter deformation and to control the position of the catheter tip. Therefore, there is a need for a measuring method and a measuring device capable of measuring accurate stiffness values by providing a standard method for measuring stiffness against nonlinear deformation of a catheter.

SUMMARY OF THE INVENTION The present invention has been made to solve the above problems, and an object of the present invention is to provide a measuring device capable of measuring rigidity against nonlinear deformation of a catheter.

It is also an object of the present invention to provide a standard method for measuring the stiffness of non-linear deformation of the catheter.

According to a feature of the present invention for achieving the above object, the apparatus for measuring bending deformation and stiffness of a multi-segment catheter using a nonlinear deformation analysis includes: a wire fixing part 30 for fixing an end of the wire 140; A sensor unit 20 provided with a sensor measuring a tension of the wire 140 fixed to the wire fixing unit 30; A catheter fixing part 40 for fixing the mounted catheter tube 100; A bottom part 50 fixing the catheter fixing part 40; A bottom control part 60 provided with a fine conveying device to convey the bottom part 50; Grid paper (70) capable of measuring the deformation curve of the catheter tube 100 is deformed; And a support part 10 supporting the sensor part 20 and the bottom part 50, wherein the tension applied to the wire 140 is transmitted to the catheter tube 100 to form a bending deformation. It is done.

By the means of solving the said subject, this invention can provide the measuring apparatus which can measure the rigidity with respect to the nonlinear deformation of a catheter.

In addition, the present invention can provide a standard method to measure the stiffness against nonlinear deformation of the catheter.

1 is a view showing a catheter deformation tester model that can be applied to the method of measuring the bending deformation and rigidity of a multi-segment catheter using a nonlinear deformation analysis.

2 is a flow chart showing a bending deformation and stiffness measurement method of a multi-segment catheter using the present invention nonlinear deformation analysis.

3 is a photograph of an experimental apparatus using the catheter deformation test apparatus model of FIG. 2.

4 is a side view of a catheter tube 100 showing a segmented catheter and a wire 140 inserted inside the catheter to provide bending deformation of the catheter.

5 is a coordinate value showing an embodiment of the nonlinear bending deformation of the beam according to the catheter deformation nonlinear bending curve formula (Equation 1) and the catheter deformation nonlinear bending curve length value (Equation 2).

FIG. 6 is a coordinate value showing a value obtained by analyzing a deformation curve of several segments and connecting them into one curve. FIG.

7 is a coordinate value according to the difference between the tangent angles at both ends of the segment according to the deformation amount.

8 is a coordinate value showing a stiffness value approaching a strain curve of the simulation strain curve and the test result.

9 is a coordinate value showing the test deformation curve according to the tension change.

10 is a coordinate value showing a simulation deformation curve according to the tension change based on the obtained stiffness value.

Hereinafter, preferred embodiments of the present invention will be described in detail with reference to the accompanying drawings, in which like reference numerals denote components that perform the same function in FIGS. 1 to 10. Meanwhile, in the drawings and detailed description of the drawings, detailed descriptions and illustrations of specific technical configurations and operations of elements not directly related to technical features of the present invention are omitted, and only the technical configurations related to the present invention are briefly shown or Explained.

Bending deformation and stiffness measuring apparatus of the multi-segment catheter using the nonlinear deformation analysis of the present invention, as shown in Figure 1, the wire fixing part 30, the sensor part 20, the catheter fixing part 40, the bottom part 50 , The bottom control portion 60 and the support 10 is composed.

First, the wire fixing portion 30 fixes the end of the wire 140. The wire fixing portion 30 can adjust the tightening by a screw to the forceps.

As shown in FIG. 4, the wire 140 penetrates through the catheter tube 100 and extends outside the catheter tube 100 to be fixed by the wire fixing part 30.

The wire fixing unit 30 is preferably provided on the front of the sensor unit 20 is provided so that the wire 140 passing through the wire fixing unit 30 passes through the sensor unit 20.

Next, the sensor unit 20 is provided with a sensor for measuring the tension of the wire 140 fixed to the wire fixing portion (30). The sensor unit 20 is preferably disposed in the longitudinal direction to measure the tension of the wire 140 provided in the longitudinal direction. The wire fixing part 30 provided on the front of the sensor unit 20 is also preferably disposed in the longitudinal direction.

Next, the catheter fixing part 40 fixes the catheter tube 100 mounted. The catheter fixing part 40 is provided at the top of the bottom part 50, and the first fixing part and the second fixing part are arranged in order on the top of the bottom part 50 to sequentially position the first fixing part and the second fixing part. The catheter tube 100 is fixed between the fixing parts.

More specifically, the first fixing part and the second fixing part are provided with a groove in the center, respectively, to form a gap by facing the groove. The catheter tube 100 penetrates between the pores and is provided to be adjustable between the pores to fix the catheter tube 100.

Next, the bottom 50 is fixed to the catheter fixing part (40). The bottom part 50 is provided at the upper end of the support part 10 and the catheter fixing part 40 is provided at the top of the bottom part 50. The bottom portion 50 is provided with an adjustment portion on the side to move back and forth in the forward (forward) direction shown in FIG.

Next, the bottom adjustment unit 60 is provided with a micro-feeding device to transfer the bottom 50. The bottom control part 60 is provided to move the bottom part 50 back and forth in the forward direction. The bottom adjustment unit 60 may be prepared in different stages by varying the adjustment step to finely control the movement of the bottom 50.

Next, the support part 10 supports the sensor part 20 and the bottom part 50. More specifically, the support 10 is provided with a vertical portion and a horizontal portion, the vertical portion supports the sensor portion 20, the horizontal portion supports the bottom portion 50.

Bending deformation and stiffness measuring device of the multi-segment catheter using the nonlinear deformation analysis of the present invention, as shown in Figure 3, after fixing the catheter tube 100 to the catheter fixing part 40, the bottom control unit 60 Advance the bottom portion 50 by) and measure the tension of the wire 140 with the sensor unit 20. As the tension is applied to the wire 140, the catheter tube 100 is deformed.

In addition, as shown in Figure 3, the bending deformation and stiffness measuring device of the multi-segment catheter using a nonlinear deformation analysis grid paper 70 for recording the deformation curve of the catheter tube 100 fixed to the catheter fixing part 40 ). The grid paper 70 is provided with a size of 1 mm or less in scale, and the deformation curve of the catheter tube 100 is measured at the top of the grid paper 70.

The bending deformation and stiffness measuring device of a multi-segment catheter using the nonlinear deformation analysis of the present invention preferably measures the bending deformation and stiffness of the multi-segment catheter according to the measuring method described below (FIG. 2).

First, the first step (S10) determines the segment according to the shape of the catheter tube 100 according to any shape, as shown in Figure 10, and inputs an arbitrary stiffness value. As shown in FIG. 10, the catheter tube 100 used in the present invention has rigidity differently for each section so that the catheter tube 100 can be accurately positioned to a required position required by the user without being easily shaken by the user's movement. More specifically, the catheter tube 100 is composed of a relatively high rigidity proximal member 110, a relatively low rigidity soft member 120 and the highest rigid end member 130.

Next, the second step S20 creates a first deformation value. More specifically, the first modification value may be calculated by the following [Formula 1] and [Formula 2]. When the catheter tube 100 is deformed, the deformation amount y is calculated by the following [Equation 1], and the curve length that is deformed when the catheter tube 100 is deformed is calculated by the following [Equation 2].

The deformation amount y of the catheter tube 100 is inversely proportional to the elastic modulus E of the material of the catheter tube 100 and the cross-sectional moment I of the cross-sectional shape of the tube by the following Equation 1, and the bending moment M It is desirable to be provided in proportion to).

[Equation 1]

[Equation 2]

At this time, E: the elastic modulus of the catheter tube (100), I: the cross-sectional moment of the cross-sectional shape of the catheter tube (100), M: the bending moment of the catheter tube (100))

Nonlinear bending deformation of the catheter tube 100 calculated by the above [Equation 1] and [Equation 2] can be prepared as shown in FIG.

Next, a third step (S30) is to create a test strain curve by segmenting the catheter tube 100 into the three zones. The test strain curve is prepared as shown in FIG. 6 by combining the first strain values of the multi-segment catheter tube 100 segmented into the three sections.

Next, the fourth step (S40) calculates the strain point by re-segmenting the catheter tube 100 when the imaginary number in the [Equation 1] and [Equation 2]. More specifically, as shown in FIG. 7, the imaginary cases in [Equation 1] and [Equation 2] are when the tangent angles of both ends of the segment divided into the three zones are less than 90 °.

When the imaginary numbers in the above [Equation 1] and [Equation 2], the catheter tube 100 is segmented at the contact point P perpendicular to the x-axis and the nonlinear bending deformation through the above [Equation 1] and [Equation 2] Calculate the point.

Next, in a fifth step S50, the calculated strain point is recorded to prepare a stiffness data curve. The strain point calculated by resegmenting the catheter tube 100 at the contact point P perpendicular to the x-axis is connected to a curve.

Next, the sixth step (S60) deforms the catheter tube 100. More specifically, the catheter tube 100 may be deformed by the tension of the wire 140. In addition, the seventh step (S70) is to obtain the test data by the modified catheter tube 100.

Next, the eighth step (S80) compares the acquired data of the fifth step (S50) and the test data of the sixth step (S60). More specifically, as shown in FIG. 8, after the strain point is connected to one curve, the deformation curve of the acquired data obtained by repeatedly adjusting the stiffness value (too flexible, too stiff) and repeatedly obtained is compared with the test strain curve. It is preferable to create a third deformation curve.

Next, in the ninth step (S90) to compare the deformation curve of the acquired data and the test deformation curve of the test data, if the same or high degree of similarity proceeds to the tenth step (S100), and if the similarity is low the first Steps S10 to 7th S70 are repeated and compared.

Next, as shown in Figures 9 to 10, the tenth step (S10) confirms whether the third strain curve prepared by applying to the tension of the other wire 140 coincides with the test strain curve.

The following shows the test strain curve values applied at different wire 140 tensions in the third strain curve prepared in the tenth step (S10).

The points (x0, y0), (x1, y1), (x2, y2), (x3, y3), (x4, y4), (x5, y5) of FIG. 9 are 0 mm in order in the longitudinal direction of the catheter, Corresponds to the positions of 100 mm, 150 mm, 225 mm, 280 mm and 295 mm.

장력 [N]Tension [N]	(x0, y0)[mm](x0, y0) [mm]	(x1, y1)[mm](x1, y1) [mm]	(x2, y2)[mm](x2, y2) [mm]	(x3, y3)[mm](x3, y3) [mm]	(x4, y4)[mm](x4, y4) [mm]	(x5, y5)[mm](x5, y5) [mm]
3.863.86	(0, 0)(0, 0)	(100, 4)(100, 4)	(149, 11)(149, 11)	(252, 34)(252, 34)	(272, 46)(272, 46)	(281, 56)(281, 56)
6.756.75	(0, 0)(0, 0)	(99, 8)(99, 8)	(148, 19)(148, 19)	(246, 54)(246, 54)	(260, 72)(260, 72)	(261, 86)(261, 86)
9.649.64	(0, 0)(0, 0)	(99, 12)(99, 12)	(146, 28)(146, 28)	(237,76)(237,76)	(242, 97)(242, 97)	(236, 109)(236, 109)
11.2611.26	(0, 0)(0, 0)	(99, 14)(99, 14)	(145, 32)(145, 32)	(232, 87)(232, 87)	(233, 107)(233, 107)	(222, 116)(222, 116)

The points (x0, y0), (x1, y1), (x2, y2), (x3, y3), (x4, y4), (x5, y5) of FIG. 10 are 0 mm in order in the length direction of the curve. Corresponds to the positions of 100 mm, 150 mm, 225 mm, 280 mm and 295 mm.

장력 [N]Tension [N]	(x0, y0)[mm](x0, y0) [mm]	(x1, y1)[mm](x1, y1) [mm]	(x2, y2)[mm](x2, y2) [mm]	(x3, y3)[mm](x3, y3) [mm]	(x4, y4)[mm](x4, y4) [mm]	(x5, y5)[mm](x5, y5) [mm]
3.863.86	(0, 0)(0, 0)	(99.7, 4.9)(99.7, 4.9)	(149.1, 10.9)(149.1, 10.9)	(251.9, 31.5)(251.9, 31.5)	(273.1, 43.8)(273.1, 43.8)	(281.5, 55.8)(281.5, 55.8)
6.756.75	(0, 0)(0, 0)	(99.4, 8.5)(99.4, 8.5)	(148.1, 19.1)(148.1, 19.1)	(246.6, 54.5)(246.6, 54.5)	(261.0, 73.5)(261.0, 73.5)	(259.7, 88.0)(259.7, 88.0)
9.649.64	(0, 0)(0, 0)	(98.9, 12.1)(98.9, 12.1)	(146.4, 27.1)(146.4, 27.1)	(238.5, 76.6)(238.5, 76.6)	(244.4, 98.3)(244.4, 98.3)	(234.4, 108.5)(234.4, 108.5)
11.2611.26	(0, 0)(0, 0)	(98.5, 14.1)(98.5, 14.1)	(145.2, 31.5)(145.2, 31.5)	(232.8, 88.4)(232.8, 88.4)	(234.4, 109.6)(234.4, 109.6)	(221.7, 116.1)(221.7, 116.1)

[Description of the code]

10. Support

20. Sensor

30. Wire fixing

40. Catheter Government

50. Bottom part

60. Floor Control

70. Grid paper

100. Catheter Tube

110. Proximal member

120. Soft Member

130. End member

140. Wire

Claims

A wire fixing part 30 fixing an end of the wire 140;

A sensor unit 20 provided with a sensor measuring a tension of the wire 140 fixed to the wire fixing unit 30;

A catheter fixing part 40 for fixing the mounted catheter tube 100;

A bottom part 50 fixing the catheter fixing part 40;

A bottom control part 60 provided with a fine conveying device to convey the bottom part 50;

Grid paper (70) capable of measuring the deformation curve of the catheter tube 100 is deformed; And

Consists of the support unit 10 for supporting the sensor unit 20 and the bottom portion 50,

The tension applied to the wire 140 is transmitted to the catheter tube 100, the bending deformation is formed, and the segmented catheter tube 100 arbitrarily segmented to measure the rigidity of the multi-segment catheter, characterized in that for measuring the rigidity Bending strain and stiffness measuring device.
The method of claim 1,

After the catheter tube 100 is fixed to the catheter fixing part 40, the bottom part 50 is advanced and the tension of the wire 140 is measured by the sensor part 20.

Bending strain and stiffness measuring device of a multi-segment catheter using a non-linear deformation analysis, characterized in that the catheter tube 100 is deformed as the tension is applied to the wire (140).
The method of claim 1,

When the catheter tube 100 is deformed, the deformation amount y is calculated by the following [Equation 1], and the curve length that is deformed when the catheter tube 100 is deformed is calculated by the following [Equation 2]. Bending deformation and stiffness measuring device of multi-segment catheter using nonlinear deformation analysis.

[Equation 1]

[Equation 2]

At this time, E: the elastic modulus of the catheter tube (100), I: the cross-sectional moment of the cross-sectional shape of the catheter tube (100), M: the bending moment of the catheter tube (100))
The method of claim 1,

The catheter tube 100 is composed of the proximal member 110, the soft member 120, the end member 130 and the wire 140 segmented for each section according to the rigidity,

The wire 140 is inserted into the catheter tube 100 of the multi-segment catheter using a non-linear deformation analysis, characterized in that the catheter tube 100 is provided to be deformed by the tension applied to the wire 140. Bending strain and stiffness measuring device.
The method of claim 1,

When the bending deformation is transmitted to the catheter tube 100 is formed

To create a deformation curve of the catheter tube 100 in the following [Equation 1] and [Equation 2],

[Equation 1]

[Equation 2]

At this time, E: the elastic modulus of the catheter tube (100), I: the cross-sectional moment of the cross-sectional shape of the catheter tube (100), M: the bending moment of the catheter tube (100))

When the values of [Equation 1] and [Equation 2] are imaginary, the catheter tube 100 is segmented at the contact point perpendicular to the x-axis, and the deformation curve is reconstructed and connected using a nonlinear deformation analysis. Bending strain and stiffness measuring device of multi-segment catheter.