JP6032971B2 - Medical device - Google Patents

Description

  The present invention relates to a medical device.

  Conventionally, a balloon or superelastic expansion member that can be expanded radially is provided at the distal end, and the balloon or superelastic expansion member is prevented from coming out by expanding the balloon or superelastic expansion member while the distal end is inserted into the body through the tissue wall. Gastrostomy catheters and trocars are known (see, for example, Patent Documents 1 and 2).

JP 2010-158486 A JP-A-9-28666

  However, when these devices of Patent Documents 1 and 2 are fixed in a state penetrating the pericardium, it is necessary to pull the pericardium away from the outer surface of the heart so as to widen the space in the pericardium. Since the membrane moves as the heart beats, this movement has the disadvantage that the device is disengaged from the pericardium.

  The present invention has been made in view of the above-described circumstances, and provides a medical device that can be maintained in a state of being penetrated through and fixed to the pericardium regardless of intense pulsation of the heart. It is aimed.

In order to achieve the above object, the present invention provides the following means.
One aspect of the present invention includes an elongated insertion portion that passes through the pericardium and is inserted into the pericardial cavity, and a fixing means that fixes a distal end of the insertion portion to the pericardium. A movable part fixed to the membrane, a fixed part fixed to the tissue outside the pericardium, and a position along the longitudinal direction of the insertion part of the movable part disposed between the fixed part and the movable part. A position adjusting means for adjusting the position of the pericardium according to the position of the pericardium , the position adjusting means being a biasing means for biasing the movable part toward the proximal side along the longitudinal direction of the insertion part. Providing devices for use.

  According to this aspect, the distal end of the insertion portion is inserted into the pericardial cavity through the pericardium, and the distal end of the insertion portion is fixed to the pericardium by the fixing means. When the pericardium is displaced by the pulsation of the heart, the position adjusting means adjusts the position of the movable part fixed to the pericardium with respect to the fixed part according to the position, so that excessive tension is generated in the pericardium. This prevents the insertion portion from being pulled out of the pericardial cavity.

In the above embodiments, the position adjusting means, Ru biasing means der for biasing the movable portion to the base end side along the longitudinal direction of the insertion portion. Wherein the biasing means may be me Oh in the tension coil spring.
In this way, with the movable part fixed to the pericardium by the fixing means provided on the movable part, the movable part is moved along the longitudinal direction of the insertion part by the biasing means constituting the position adjusting means. By biasing to the side, the pericardium can be pulled away from the heart and the space in the pericardial cavity can be expanded. In this case, even if the position of the pericardium fluctuates, the biasing means continues to urge the pericardium away from the heart, so that the movable part follows the pericardial displacement, and excessive tension is applied to the pericardium. Occurrence can be prevented.

In the above aspect, the fixed portion is configured in a cylindrical shape having a through hole extending in the longitudinal direction of the insertion portion, and the movable portion is fitted in the through hole of the fixed portion so as to be movable in the longitudinal direction. The urging means may be disposed in the through hole of the fixed portion.
In this way, when the movable part is arranged at a position penetrating the pericardium, the fixed part is arranged at a position penetrating the subcutaneous tissue outside the pericardium, but is arranged in the through hole of the cylindrical fixed part. The applied urging means is covered with the fixing portion and does not need to contact the subcutaneous tissue directly. This prevents the movement of the movable part and the biasing means movably fitted to the fixed part from being inhibited by the subcutaneous tissue, and allows the movable part to smoothly follow the pericardial fluctuations.

A second aspect of the present invention includes an elongated insertion portion that passes through the pericardium and is inserted into the pericardial cavity, and a fixing means that fixes the distal end of the insertion portion to the pericardium. A movable part fixed to the membrane, a fixed part fixed to the tissue outside the pericardium, and a position along the longitudinal direction of the insertion part of the movable part disposed between the fixed part and the movable part. A position adjusting unit that adjusts according to the position of the pericardium; a detection unit that detects the movement of the pericardium; and a control that controls the position adjusting unit based on the movement of the pericardium detected by the detection unit. and a section, the position adjusting means, providing the insertion portion medical devices Ah Ru by an actuator that displaces the longitudinal direction of the movable portion relative to said stationary portion.
According to this aspect, the control unit controls the actuator based on the movement of the pericardium detected by the detection unit , thereby causing the movable unit to follow the movement of the pericardium more actively. Can be prevented from falling off.

  According to the present invention, there is an effect that the pericardium can be maintained in a fixed state regardless of intense heartbeat.

It is a medical device which concerns on one Embodiment of this invention, Comprising: (a) The state which deflated the balloon, (b) The longitudinal cross-sectional view which shows the state which expand | swelled the balloon, respectively. It is a longitudinal cross-sectional view which shows the state which mounted | wore the medical device of FIG. 1 with the dilator. 1 shows a state in which the medical device of FIG. 1 is (a) penetrated through the pericardium, (b) a state where the balloon is inflated, and (c) a state where tension is applied to the pericardium by hooking the balloon onto the pericardium. FIG. It is a longitudinal cross-sectional view which shows the 1st modification of the medical device of FIG. It is a longitudinal cross-sectional view which shows the 2nd modification of the medical device of FIG. It is a whole block diagram which shows the 3rd modification of the medical device of FIG. In the medical device of FIG. 6, (a) the actuator is contracted, and (b) the actuator is expanded, showing longitudinal sections. FIG. 7 is a partially enlarged longitudinal sectional view of a distal end portion of a movable portion showing a modification of the detection unit of the medical device in FIG. 6. It is the fixing method to the subcutaneous tissue of the fixing | fixed part of the medical device of FIG. 1, Comprising: (a) The state at the time of insertion, (b) It is a longitudinal cross-sectional view which respectively shows the state at the time of fixation.

A medical device 1 according to an embodiment of the present invention will be described below with reference to the drawings.
The medical device 1 according to the present embodiment is an access port that penetrates the pericardium and is placed in a state where the tip is inserted into the pericardium.

As shown in FIGS. 1A and 1B, the medical device 1 according to the present embodiment includes a cylindrical insertion portion 2 having a through hole 2 a penetrating in the longitudinal direction, and a distal end of the insertion portion 2. Is fixed to the pericardium A (see FIG. 3).
The insertion part 2 includes a fixed part 2b fixed outside the body, a movable part 2c fixed to the pericardium A, and an urging means (position adjusting means) 2d arranged therebetween.

For example, when the insertion unit 2 penetrates the pericardium A, the fixing means 3 contracts as shown in FIG. 1A to facilitate the penetration, and after penetration, the fixing means 3 is shown in FIG. 1B. In this way, the balloon is inflated (hereinafter also referred to as balloon 3). When the balloon 3 is inflated, it expands outward in the radial direction and expands its outer diameter.
The biasing means 2d is a tension coil spring. Both ends of the urging means 2d are fixed by being partially embedded in the fixed portion 2b and the movable portion 2c, respectively.

The operation of the medical device 1 according to this embodiment configured as described above will be described below.
In order to fix the medical device 1 according to the present embodiment while penetrating the pericardium A, first, the pericardium A is penetrated by a puncture needle (not shown), and a guide wire (not shown) is installed through the puncture needle. . Then, the puncture needle is removed and only the guide wire is placed in a state of penetrating the pericardium A.

  In this state, as shown in FIG. 2, the dilator 4 is assembled to the through hole 2 a of the insertion portion 2 of the medical device 1 according to this embodiment. At this time, the balloon 3 is in a deflated state.

  The dilator 4 has a tapered portion 4a that smoothly connects to the tip of the movable portion 2c at the tip, and a through hole 4b having a diameter that can penetrate the guide wire. The assembly of the dilator 4 and the medical device 1 is advanced along the guide wire in a state where the guide wire is passed through the through hole 4b. Thereby, the tissue is pushed open by the tapered portion 4a at the tip of the dilator 4 to advance the assembly, and further, the hole formed in the pericardium A is expanded by the tapered portion 4a.

Then, as shown in FIG. 3A, the dilator 4 and the guide wire are removed while the assembly is advanced until the balloon 3 provided in the movable part 2c completely enters the pericardium A.
In this state, as shown in FIG. 3 (b), the tip of the movable portion 2 c can be prevented from coming out of the pericardium A by inflating the balloon 3.

  Then, as shown in FIG. 3C, when an external force is applied in a direction in which the fixed portion 2b is pulled away from the movable portion 2c, the external force is transmitted to the movable portion 2c via the biasing means 2d, and the movable portion 2c is centered. It moves in the direction of being extracted from the film A. Since the balloon 3 provided in the movable part 2c is inflated so as to increase the outer diameter, the balloon 3 is caught by the pericardium A, and the escape is prevented.

  Further, when an external force is further applied to the fixed portion 2b while the balloon 3 is caught on the pericardium A, the external force transmitted to the movable portion 2c is also transmitted to the pericardium A, and the pericardium A is pulled, The pericardial space between the surface and the surface is enlarged. And when the urging means 2d extends, the tension generated in the pericardium A and the external force applied to the fixed portion are balanced.

  In this state, when the pericardium A is displaced in the direction of the arrow due to the heartbeat, the tension acting on the pericardium A changes, but the biasing means 2d expands and contracts to balance the fluctuation in tension. It is possible to prevent the tension acting on the pericardium A from becoming excessive, and to prevent the movable portion 2c from coming out even if the pericardial A position fluctuates. Further, since the movable portion 2c is displaced following the displacement of the pericardium A, the pericardial cavity is maintained in an expanded state, and observation or treatment with an endoscope or a treatment instrument introduced through the through hole 2a is easy. Can be.

  In the present embodiment, the balloon 3 is illustrated as the fixing means 3, but other arbitrary fixing means may be adopted instead. Moreover, although the tension coil spring is illustrated as the urging means 2d, it is not limited to this, and any urging means such as a rubber tube or a leaf spring may be adopted.

  Further, in the present embodiment, the structure in which the urging means 2d is exposed radially outward is illustrated, but instead of this, as shown in FIG. 4, the urging means 2d is applied to the fixed portion 2b. By providing the cylindrical portion 5 that covers the outer side in the radial direction, the biasing means 2d may not be exposed outward in the radial direction.

  When the medical device 1 is an access port attached to the pericardium A, subcutaneous tissue exists around the biasing means 2d. When the pressure of the subcutaneous tissue is high, the subcutaneous tissue bites into the urging means 2d. In this case, the operation of the urging means 2d, and hence the operation of the movable part 2c, may be hindered. Therefore, the urging means 2d is covered with the cylindrical part 5 to prevent the subcutaneous tissue from contacting the urging means 2d. As a result, the movable portion 2c can be operated more smoothly.

  Further, when the pressure of the subcutaneous tissue is higher and there is a possibility that the movement of the movable part 2c may be hindered even by the structure of FIG. 4, the movable part 2c is made to have a double structure as shown in FIG. Also good. That is, in the example shown in FIG. 5, the first movable portion 6a is movably connected to the fixed portion 2b by the first urging means 7a, and the second movable portion 6b is connected to the first movable portion 6a. The urging means 7b is movably connected.

The first urging means 7a is covered radially outward by a cylindrical portion 5a provided on the fixed portion 2b, and the second urging means 7b is a cylindrical shape provided on the first movable portion 6a. The outer side in the radial direction is covered by the portion 5b.
With this configuration, even when the pressure of the subcutaneous tissue is high, the subcutaneous tissue is prevented from biting into the first and second urging means 7a and 7b. Further, even when the pressure of the subcutaneous tissue is high and the operation of the first movable part 6a is hindered by friction, the second movable part 6b is displaced to achieve the retaining effect and the effect of expanding the pericardial cavity. be able to.

  In the present embodiment, biasing means such as a tension coil spring is used as the position adjusting means, but a bellows incorporating a tension coil spring may be employed instead. Thereby, it can prevent that a subcutaneous tissue approachs into the through-hole 2a from between the lines of a coil spring.

Further, as the position adjusting means, the actuator 8 may be arranged between the fixed portion 2b and the movable portion 2c instead of the biasing means.
As the actuator 8, for example, a direct acting actuator 8 such as an air cylinder can be adopted. In the example shown in FIG. 6, a detection unit 9 that detects the movement of the pericardium A , an actuator 8 formed of an air cylinder, and a control unit 10 that controls the actuator 8 are provided.

The detection unit 9 detects an electrocardiographic waveform, for example.
When the heart expands and the pericardium A is displaced outward based on the electrocardiographic waveform detected by the detection unit 9, the control unit 10 contracts the actuator 8 as shown in FIG. When the heart contracts and the pericardium A is displaced inward, as shown in FIG. 7B, the movable portion is made to follow the movement of the pericardium A by extending the actuator 8. .

By doing so, there is an advantage that the actuator 8 can be controlled so that the tension applied to the pericardium A is constant, and an excessive load can be prevented from being applied to the pericardium A.
In addition to detecting the electrocardiogram waveform, the detection unit 9 is arranged at the distal end of the movable unit 2c as shown in FIG. 8, and the pressure in the pericardial space or between the pericardium A and the heart The sensor 11 for detecting the distance may be used. Further, a weight sensor (not shown) provided at a connection portion between the movable portion 2c and the actuator 8 and detecting pressure applied to the movable portion 2c may be employed.

  Further, in order to fix the fixing portion 2b to the subcutaneous tissue B, as shown in FIG. 9, the fixing portion 2b is provided by the slider 12 provided to be movable in the longitudinal direction with respect to the fixing portion 2b, and the operation of the slider 12. It is also possible to employ one having a protrusion 13 that protrudes in the radial direction. As shown in FIG. 9A, the protrusion 13 extends along the outer peripheral surface of the movable portion 2c when the slider 12 is pulled backward with respect to the fixed portion 2b, and is inserted into the subcutaneous tissue B. 9b, when the slider 12 is pushed forward with respect to the fixed portion 2b as shown in FIG. 9B, it protrudes radially outward from the outer peripheral surface of the movable portion 2c and bites into the surrounding subcutaneous tissue B. It is like that.

  In this way, after the balloon 3 is inflated, the fixing portion 2b is pulled in the direction of extracting from the subcutaneous tissue B, and is fixed at an appropriate position where the balloon 3 is hooked on the pericardium A and the pericardium A is pulled away from the surface of the heart. By pushing the slider 12 forward with respect to the portion 2b, the protruding portion 13 can be bitten into the subcutaneous tissue B and the fixing portion 2b can be fixed at an arbitrary position of the subcutaneous tissue B. Further, instead of the slider 12 and the protruding portion 13, the fixing portion may be fixed so as not to move on the patient's body by a belt or the like (not shown).

In the present embodiment, the access port is illustrated as an example of the medical device, but instead, a similar structure may be employed at the distal end of the insertion portion of the endoscope.
In the above embodiments, the axial length of the movable portion 2c is shorter than that of the fixed portion 2b. Instead, the movable portion 2c may be longer than the fixed portion 2b.

A Pericardium B Subcutaneous tissue (tissue)
DESCRIPTION OF SYMBOLS 1 Medical device 2 Insertion part 2a Through-hole 2b Fixed part 2c Movable part 2d, 7a, 7b Energizing means (position adjustment means)
3 Balloon (fixing means)
8 Actuator 9 Detection unit 10 Control unit

Claims (4)

An elongated insertion section that penetrates the pericardium and is inserted into the pericardial cavity;
Fixing means for fixing the distal end of the insertion portion to the pericardium,
The insertion portion is disposed between the movable portion fixed to the pericardium, the fixed portion fixed to the tissue outside the pericardium, the fixed portion and the movable portion, and the insertion portion of the movable portion. A position adjusting means for adjusting the position along the longitudinal direction according to the position of the pericardium ,
The medical device, wherein the position adjusting means is an urging means for urging the movable portion toward the proximal end along the longitudinal direction of the insertion portion . The medical device according to claim 1, wherein the biasing means is a tension coil spring . The fixing part is configured in a cylindrical shape having a through hole extending in the longitudinal direction of the insertion part,
The movable part has a shape fitted in the through hole of the fixed part so as to be movable in the longitudinal direction,
The medical device according to claim 2, wherein the urging means is disposed in the through hole of the fixing portion. An elongated insertion section that penetrates the pericardium and is inserted into the pericardial cavity;
Fixing means for fixing the distal end of the insertion portion to the pericardium,
The insertion portion is disposed between the movable portion fixed to the pericardium, the fixed portion fixed to the tissue outside the pericardium, the fixed portion and the movable portion, and the insertion portion of the movable portion. Position adjustment means for adjusting a position along the longitudinal direction according to the position of the pericardium, a detection unit for detecting the movement of the pericardium, and the position based on the movement of the pericardium detected by the detection unit A control unit for controlling the adjusting means,
It said position adjusting means, wherein the insertion portion Ah Ru Medical Ryoyo device actuator for longitudinal displacement of the movable portion relative to said stationary portion.

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