JP2016158804A - Pericardium puncture device - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a pericardium puncture device capable of puncturing a pericardium reliably while causing an endoscope to visualize a pericardium cavity as a narrow space.SOLUTION: The pericardium puncture device comprises: a lumen shaft including at least three hollow channels; lighting means irradiating a pericardium with light from a light source; imaging means imaging the pericardium irradiated by the lighting means; forceps gripping the pericardium; a puncture needle puncturing the pericardium gripped by the forceps; and a hollow and hard sheath member covering the lumen shaft around an axis. The imaging means and/or lighting means, forceps, and puncture needle are inserted into different channels respectively. The forceps and puncture needle are inserted into different channels respectively, pulled out, and can be protruded at a distal side tip of the channels. The imaging means is fixed in the channel.SELECTED DRAWING: Figure 1

Description

The present invention relates to a pericardial puncture device that punctures a pericardial membrane covering a living heart.

One of the conditions causing obstructive shock is cardiac tamponade. This cardiac tamponade is a highly urgent condition in which a large amount of fluid (or gas) accumulates in the pericardium, causing shock due to decreased cardiac output and sudden cardiac arrest due to decreased coronary blood flow from diastole of the heart . As a technique for releasing this cardiac tamponade, there is a technique called pericardial puncture.

The pericardium is a conical thin film-like sac containing the heart and the beginning of the aorta. The pericardium is filled with fluid, functions to prevent dilation of the ventricles, lubricate the surface of the heart, hold the heart in a defined shape position, and infect from adjacent organ tissues in the thoracic cavity It also serves as a barrier to the spread of blood and prevents surrounding tissue (s) from adhering to the heart. The pericardial space, which is the gap between the pericardium and the heart, is usually small in volume and contains liquid (usually about 50 ml). When blood suddenly accumulates in this pericardial space due to bleeding or the like, acute cardiac tamponade occurs with a relatively small amount of blood (about 100 ml, hereinafter also referred to as “pericardial fluid”).

One technique for releasing acute cardiac tamponade is pericardial puncture. In pericardial puncture, usually, a puncture site in which pericardial effusion is stored is first confirmed visually or by echocardiography, and a test puncture is performed on the pericardium, followed by a main puncture with the position of the test puncture as a guide. Next, after inserting the guide wire and inserting the catheter along the guide wire, after confirming the position of the catheter, the catheter is connected to the extension tube to collect and drain the pericardial fluid. This pericardial puncture is often urgently performed and puncturing with visual or echocardiography is a technical and empirical hurdle for medical professionals, and development of a highly safe device Is desired. As one of them, an endoscopic technique is awaited, but there is a current situation in which an endoscope cannot sufficiently cope with structural problems such as diameter and mobility.

For example, Patent Document 1 discloses a pericardial puncture device in which a puncture needle is inserted into a jaw capable of grasping a pericardium and this is passed through an endoscope. However, since this structure is complicated, an endoscope is disclosed. However, it is necessary to have a small diameter, and sufficient operability cannot be secured in the vicinity of an important tissue such as a pericardium. In addition, inadequate operability of the endoscope means that a field of view from an appropriate position cannot be obtained, and there are technical and empirical hurdles for medical staff, such as a device for obtaining a wide field of view with a perspective mirror. Remained high.

JP-T-2001-505464

The present invention was created in view of the above problems, and an object of the present invention is to provide a pericardial puncture device that can reliably perform pericardial puncture while visually recognizing a narrow space pericardial space with an endoscope. To do.

The present invention
A lumen shaft having at least three hollow channels;
An illumination means for irradiating the pericardium with light from a light source;
Imaging means for imaging the pericardium irradiated by the illumination means;
Forceps for gripping the pericardium,
A puncture needle that punctures the pericardium grasped by the forceps;
A hollow, hard sheath member that covers the lumen shaft around its axis,
The imaging means and / or the illumination means, the forceps, and the puncture needle are inserted into separate channels, respectively.
The forceps and the puncture needle can be inserted into and removed from the respective channels and protruded to the distal tip of the channel,
The imaging means provides a pericardial puncture device for puncturing the pericardial membrane that is fixed in the channel.

In the pericardial puncture device, the lumen shaft is inserted into the sheath member having a hard lumen, and the illumination unit irradiates light from a light source to the pericardium in each channel provided in the lumen shaft. And the imaging means for imaging the pericardium irradiated by the illumination means, the forceps for gripping the pericardium, and the puncture needle for puncturing the pericardium gripped by the forceps Are arranged in parallel. Therefore, the pericardial puncture device of the present invention has a small diameter, and while the necessary visual field is secured, the pericardial membrane is grasped and positioned using forceps, and the pericardial puncture device is surely and precisely punctured. Is possible. Further, in the pericardial puncture device, since the puncture needle and the forceps can be easily inserted or removed from the channel, it can also be used as an insertion channel when blood is discharged or when using other instruments. It is also advantageous in that it has properties.

The forceps are coupled to the shaft longer than between both ends of the channel, the proximal operation portion coupled to the proximal end portion of the shaft, and the distal end portion of the shaft, and are opened and closed by operating the gripping portion. It is composed of an arm member that can grip and pull the pericardium,
Preferably, the arm member is retractable in the channel in a closed state and has a gripping force required for predetermined pericardial traction of the pericardium.

Since the forceps can be inserted through the channel in the lumen shaft, the width in the state in which the arm member at the distal end is closed is smaller than the channel diameter in combination with the above-described requirement for the diversity of the pericardial puncture device. . Further, the arm member has a strength that can sufficiently withstand a desired force required for pericardial grasping and pulling.

The imaging means is a C-MOS camera, and the illumination means is an optical fiber,
It is desirable that the C-MOS camera and the optical fiber are fixedly arranged in parallel in the same channel.

In the pericardial puncture device of the present invention, an ultra-small C-MOS camera is mounted as the imaging means, and the head portion diameter of the C-MOS camera is 1.2 mm. Further, an optical fiber is used as the illumination means, and an LED provided outside the pericardial puncture device is used as a light source. By using the C-MOS camera and the optical fiber that are reduced in size and weight, the C-MOS camera and the optical fiber can be placed inside a very thin channel having a diameter of 2.0 mm. It is.

The diameter of the lumen shaft is preferably about 3 mm.

Moreover, it is desirable that the optical axis of the emitted light from the imaging means and the direction in which the puncture needle and the forceps protrude from the lumen shaft are substantially parallel.

Furthermore, the C-MOS camera and the distal tip of the optical fiber include a lens member,
It is desirable that the degree of diffusion of light from the optical fiber through the lens member is greater than or equal to the viewing angle at the focal position of the C-MOS camera through the lens member.

Therefore, in the pericardial puncture device, the sheath member and the lumen shaft have a small diameter with respect to the viewing angle (actual viewing angle) of the C-MOS camera, and the puncture, forceps and illumination means, and the C-MOS camera are arranged separately. Even if it is done, a sufficient range of irradiation light and imaging ability can be ensured efficiently, and a clear pericardial image can be provided.

The viewing angle of the C-MOS camera is preferably 100 °.

As described above, according to the pericardial puncture device of the present invention, an ultra-thin pericardial puncture device is obtained by using a small-sized forceps, a small C-MOS camera, and an optical fiber. The tip of the device can be inserted relatively easily through a narrow gap obstructed by the sternum or the diaphragm and can reach the pericardial membrane. In addition, in the conventional pericardial puncture, the indirect and unclear field of view using an echo or the like has been secured, but by using an optical fiber and real-time imaging using a small C-MOS camera, The practitioner can perform pericardial puncture while ensuring a very clear visual field.

Each channel through which the forceps and the puncture needle are inserted has a versatile role.During the pericardial puncture or after the pericardial puncture, drugs can be injected into the patient's chest from these two channels, or the epicardium can be inserted. It is possible to use a wide range of applications such as inserting or removing instruments necessary for external ablation from the two channels.

FIG. 1A is a schematic diagram showing an outline of a pericardial puncture device according to the present embodiment, in which FIG. 1A shows the entire pericardial puncture device, and FIG. It is an enlarged view in the distal end portion. In selection of the forceps which concern on this embodiment, it is a scatter diagram which compared the tip forceps part diameter and the grasping force intensity | strength in 11 types of trial manufacture. In selection of the forceps which concern on this embodiment, it is the photograph figure which showed the tip forceps part in 11 types of trial manufacture. It is the top view which showed the structure of the forceps concerning this embodiment. 5A and 5B are schematic views showing the structure of an endoscope apparatus according to the present embodiment, in which FIG. 5A shows the entire endoscope apparatus, and FIG. 5B is a distal tip of the endoscope apparatus. FIG. 5C is a side view of the distal end portion of the endoscope apparatus viewed from the axial direction. It is the photograph figure which showed the external appearance of the C-MOS camera which concerns on this embodiment. FIG. 7A is an explanatory diagram showing a procedure for performing pericardial puncture using the pericardial puncture device according to the present embodiment, and FIG. 7A shows a step of inserting a guide wire into the chest of a patient. (B) shows the process of inserting a sheath into the patient's chest, and FIG. 7 (c) is a schematic diagram showing the process of inserting the pericardial puncture device of the present invention into the patient's chest. It is explanatory drawing which showed the procedure of the pericardial puncture using the pericardial puncture device which concerns on this embodiment, Comprising: FIG. 8 (a) shows the process of hold | gripping the pericardium using forceps, FIG. 8B is a schematic diagram showing a step of puncturing the pericardial sac using a puncture needle.

Hereinafter, embodiments of the pericardial puncture device according to the present invention will be described in detail with reference to FIGS. 1 to 6, but the present invention is not limited to those illustrated. Moreover, since each drawing is for conceptually explaining the present invention, the shape or number may be exaggerated or simplified as necessary for easy understanding. Further, in the following description, the same or corresponding parts are denoted by the same reference numerals, and redundant description may be omitted.

<< Configuration of pericardial puncture device >>
FIG. 1A shows a pericardial puncture device 1, and FIG. 1B shows an enlarged view of a distal tip of the pericardial puncture device 1. As shown in FIG. 1 (a), a pericardial puncture device 1 includes a resin-made lumen shaft 2 that is the main body of the device, and a grasped by an operator during pericardial puncture. In order to operate the endoscope device L1, the device gripping portion E1 on the proximal side of the lumen shaft 2, the device insertion portion E2 extending from the device gripping portion E1 to the distal tip and inserted into the chest of the patient Endoscope processor E3. The device gripping part E1 is provided with a forceps hole H1 into which a forceps 10 for performing pericardial puncture is inserted, and a puncture needle hole H4 into which the puncture needle 12 is inserted. The resin-made lumen shaft 2 shown here has a double structure, and the hardness of the inner layer (around channels E2, E4, E5) is 70 on Shore D, and the hardness of the outer layer of the other d Is 72 on Shore D.

The device insertion portion E2 has a forceps insertion channel E4 and a puncture needle insertion channel E5 (see FIG. 1B). As shown in FIG. 1B, these two insertion channels are used for pericardial puncture. The device 1 has a distal forceps port H2 and a distal puncture needle port H3 opened at the distal end of the lumen shaft 2 in the device 1. A forceps 10 to be described later is inserted into the forceps insertion channel E4, and an elongated puncture needle 12 having a substantially linear shape is inserted into the puncture needle insertion channel E5. Furthermore, the distal end of the lumen shaft 2 is provided with an endoscope device L1 having an optical fiber in addition to the distal forceps port H2 and the distal puncture needle port H3. In addition, the structure of the pericardial puncture device 1 is not particularly limited to the one having the above-described configuration, and it is conceivable to use a pericardial puncture device 1 having another structure.

Since the pericardial puncture device 1 of the present invention uses the lumen shaft 2 having no flexibility in the device body, the pericardial puncture device 1 may be bent during pericardial puncture. In addition, even in the dual channel of the forceps insertion channel E4 and the puncture needle insertion channel E5 provided in the lumen shaft 2, it does not bend during the pericardial puncture operation. That is, the forceps 10 and the puncture needle 12 that are inserted through these two channels can perform a linear insertion operation during the pericardial puncture operation, and can therefore be kept substantially coaxial with the lumen shaft 2 at all times. Therefore, the movement of the forceps 10 and the puncture needle 12 is imaged in real time using the ultra-small endoscope device L1 provided at the distal end of the lumen shaft 2 at an imaging viewing angle of 100 °. can do. For this reason, the surgeon securely grasps the pericardial membrane using the forceps 10 and punctures the pericardial membrane using the puncture needle 12 while visually recognizing the pericardial space from the captured clear image. It becomes possible.

《Forceps configuration》
In the pericardial puncture device 1 of the present invention, the forceps 10 is one key device, and greatly affects the performance of the entire pericardial puncture device 1. The lumen shaft 2 of the pericardial puncture device 1 of the present invention is required to have an outer diameter of 3.0 mm or less, and the forceps 10 is inserted into the forceps insertion channel E4 according to the outer diameter size of the lumen shaft 2. It is necessary to make the diameter of 1.0 mm to 1.2 mm or less. The forceps that matched this condition were prototyped and selected.

The evaluation in the trial production of forceps used in the pericardial puncture device 1 of the present invention will be described with reference to FIGS. FIG. 2 is a scatter diagram that compares the tip forceps diameter and the strength of the gripping force in eight types of prototypes, and FIG. 3 is a photograph showing the tip forceps portions in eleven types of prototypes.

The forceps (1) K1 has a crocodile shape at the distal forceps portion, a shaft diameter of 1.45 mm, a distal forceps portion diameter of 1.56 mm, and a forceps gripping portion of 7.0 mm. Forceps (1) K1 corresponds to a class having a smaller diameter than existing forceps, and has a stable structure with a high gripping force at the distal forceps portion. However, neither the shaft diameter nor the distal forceps portion diameter satisfied the required specifications of the forceps used in the pericardial puncture device 1 of the present invention.

The forceps (2) K2 has an alligator-shaped tip forceps portion with a shaft diameter of 0.95 mm, a tip forceps portion diameter of 0.95 mm, and a forceps gripping portion of 4.7 mm. It is a forceps suitable for the required specification in the pericardial puncture device 1 of the present invention. Although the pericardium was successfully grasped with the forceps (2) K2, it was difficult to stably grasp the pericardium, and it was not possible to provide good durability.

The forceps (3) K3 has a crocodile shape only at the tip of the distal forceps portion, and has a shaft diameter of 1.40 mm, a distal forceps portion diameter of 3.57 mm, and a forceps gripping portion of 5.0 mm. Compared with other forceps, both the shaft diameter and the tip forceps part diameter are thick, but by curving the tip forceps part, the local gripping force is strengthened and has the highest gripping force in the eight types of prototypes. . However, since the distal forceps portion is bent, the diameter of the distal forceps portion is increased, which does not satisfy the required specifications of the forceps used in the pericardial puncture device 1 of the present invention.

The forceps (4) K4 has an alligator-shaped tip forceps portion with a shaft diameter of 1.16 mm and a tip forceps portion diameter of 1.16 mm. Both the shaft diameter and the tip forceps part diameter are compatible with the required specifications of the forceps used in the pericardial puncture device 1 of the present invention, but because the structure is such that the tip forceps part is pulled into the shaft part to hold it. When gripping is repeated, the shape of the distal forceps portion is deformed. Further, the pericardium cannot be grasped by the grasping mechanism of the forceps (4) K4.

The forceps (5) K5 has a crocodile shape at the distal forceps portion, a shaft diameter of 1.40 mm, a distal forceps portion diameter of 1.74 mm, a forceps gripping portion of 3.0 mm, and the distal forceps portion has short teeth and a large shape. Although it does not satisfy the required specifications of the forceps used in the pericardial puncture device 1 of the present invention, it has high durability and has a strong gripping force. Forceps (5) K5 succeeded in grasping the pericardial membrane multiple times in animal experiments using pigs.

The forceps (6) K6 has an alligator-shaped tip forceps portion with a shaft diameter of 0.96 mm, a tip forceps diameter of 1.03 mm, and a forceps gripping portion of 3.5 mm. In order to make the distal forceps diameter smaller, all the parts constituting the forceps (6) K6 are designed. The forceps (6) K6 succeeded in grasping the pericardium in an animal experiment using pigs, but was structurally unstable and could not have good durability.

The forceps (7) K7 has an alligator-shaped tip forceps portion with a shaft diameter of 0.97 mm, a tip forceps portion diameter of 1.16 mm, and a forceps gripping portion of 3.4 mm. The direction of the teeth in the distal forceps portion is processed obliquely, and the pericardium can be grasped more easily. In an animal experiment using forceps (7) K7, the teeth were effectively held in contact with the pericardium, but were not able to have good durability and were damaged.

The forceps (8) K8 is provided with teeth only at the tip of the tip forceps portion, and has a shaft diameter of 1.00 mm, a tip forceps portion diameter of 1.05 mm, and a forceps gripping portion of 3.2 mm. The forceps (8) K8 succeeded in grasping the pericardium easily several times in animal experiments using pigs, and was able to have good structure and durability.

The forceps (9) K9 has teeth only at the tip of the tip forceps portion, and has a shaft diameter of 1.20 mm, a tip forceps portion diameter of 1.20 mm, and a forceps gripping portion of 2.7 mm. By shortening the gripping part of the forceps, it was designed to be small. The forceps (9) K9 succeeded in grasping the pericardium easily several times in animal experiments using pigs, and was able to have good structure and durability.

The forceps (10) K10 is provided with teeth only at the tip of the tip forceps portion, and has a shaft diameter of 1.00 mm, a tip forceps portion diameter of 1.15 mm, and a child gripping portion of 2.9 mm. The height of the forceps teeth was 0.3 mm so as not to damage the pericardial membrane. The forceps (10) K10 easily succeeded in grasping the pericardial membrane several times in an animal experiment using a pig, and was able to have a good structure and durability.

The forceps (11) K11 is provided with a tooth only at the tip of the tip forceps portion, and has a shaft diameter of 1.15 mm, a tip forceps portion diameter of 1.20 mm, and a child gripping portion of 3.5 mm. The forceps (11) K11 easily succeeded in grasping the pericardial membrane several times in an animal experiment using a pig, and was able to have a good structure and durability.

The forceps (1) K1 and the forceps (3) K3 have high gripping force strength, and it is considered that the height of the teeth at the distal forceps portion and the thick shaft influence the gripping force strength. The shape of the forceps (4) K4 and forceps (5) K5 is narrow, but the grip strength is higher than that of the forceps (2) K2, but it is gripped by pulling the tip forceps into the shaft. This structure is not suitable for use in pericardial puncture. The forceps (2) K2 is thin in both the shaft diameter and the tip forceps diameter, and has a high gripping force strength. However, the forceps (2) K2 could not have good durability such as breakage when gripped multiple times. . However, the forceps (8) K8, the forceps (9) K9, the forceps (10) K10, and the forceps (11) K11 have excellent gripping regardless of whether the shaft diameter and the tip forceps diameter are less than 1.2 mm of the required specifications. The strength and durability are both compatible, and in particular, the forceps (11) K11 most satisfy the required specifications of the forceps used in the pericardial puncture device 1 of the present invention. Based on the above results, the forceps (11) K11 is the forceps 10 used in the pericardial puncture device 1 of the present invention, and will be described in detail below.

The structure of the forceps 10 used in the pericardial puncture device 1 of the present invention will be described with reference to FIG. FIG. 4 is a plan view showing the structure of the forceps 10. The forceps 10 used in the pericardial puncture device 1 of the present invention comprises a hand operating portion 14 at the proximal end of the main body of the forceps 10 and is provided at the distal end of the shaft 16 by operating the hand operating portion 14. The forceps portion 18 is remotely opened and closed to grasp a desired portion of the pericardial membrane. Further, the outer diameter of the shaft 16 is approximately 1.0 mm, and the forceps 10 configured using the shaft 16 has a very small diameter.

The hand operation unit 14 includes a grip unit 20, a body unit 21, and an operation switch unit 22. The operation switch part 22 is fixed to the body part 21 with a fixing pin 23 at the center, and is configured to be movable up and down at both ends on the distal side and the proximal side with the center as a fulcrum. By moving the operation switch portion 22 up and down, the operation shaft 24 inserted into the shaft 16 is slid in the front-rear direction, so that the forceps portion 18 can be opened and closed. Since the pericardial puncture device 1 of the present invention needs to reach the pericardial membrane through a very narrow space between the ribs and the diaphragm, the shaft 16 of the forceps 10 needs a very small diameter size.

The forceps 18 has a pair of opening / closing arm members 26. The pair of opening / closing arm members 26 intersect with each other, and a single pivot pin 30 passes through the intersection, and the forceps 18 can be opened and closed by pivotally attaching the pair of opening / closing arm members 26. It is said. The distal ends of the connection plates 32 are connected to the base ends of the open / close arm members 26 by the pivot pins 34, respectively, and the rear ends of the connection plates 32 are gathered together at the distal ends of the operation shafts 24 to form one pivot pin 36. It is pivoted through.

<< Configuration of endoscope apparatus >>
Next, the configuration of the ultrafine endoscope apparatus L1 used in the pericardial puncture device 1 of the present invention will be described using FIGS. 5 (a), (b), and (c). The endoscope apparatus L1 is configured by a generally hollow shaft portion 50, and transmits light from a light source (LED (not shown)) to an observation site near the distal end of the shaft portion 50. And an optical fiber 63 as an illuminating means for irradiating, and an imaging means for imaging an observation site irradiated by the optical fiber 63. The imaging means may be a photoelectric conversion element that detects light from the observation site and generates a charge, and an objective lens may be provided between the imaging device and the observation site.

As the image sensor, a CMOS image sensor (hereinafter also referred to as “C-MOS camera”), a CCD image sensor, or the like can be used. As a result, an image of the observation site can be obtained as electronic data. Here, a small C-MOS camera (manufactured by Medigus) shown in the photograph of FIG. 5 was used as the imaging means. The C-MOS camera 65 has a head portion with a diameter of 1.2 mm and an actual field of view of 100 °. In FIG. 6, the ruler and the index finger are shown for easy understanding of the dimension image of the C-MOS camera 65. A signal cable 71 extends from the lower part of the C-MOS camera 65, and the signal cable 71 is inserted through the hollow shaft portion 50 and connected to the endoscope processor E3 shown in FIG. The C-MOS camera 65 can be operated by the endoscope processor E3.

As shown in FIGS. 5B and 5C, the C-MOS camera 65 and the optical fiber 63 are arranged in a radial direction and are mounted in a tube 67 made of metal and in a hollow cylindrical shape. The ends of the C-MOS camera 65 and the optical fiber 63 are bonded to a dustproof cover 69. Further, the imaging signal of the C-MOS camera 65 is transmitted to the endoscope processor E3 via the signal cable 71.

The light transmitted through the optical fiber 63 as the illumination means uses a light emitting diode (LED (not shown)) as a light source, and the LED 61 is built in the endoscope processor E3. As a result, the light quantity of the LED 61 can be automatically controlled by the control of the endoscope processor E3. Since the LED 61 is smaller and lighter than conventional light sources such as halogen and xenon lamps, the LED 61 can be easily built into the endoscope processor E3 shown in FIG. Is supplied from the cable 60.

Light emitted from the LED 61 is incident on and transmitted to the proximal ends of the plurality of optical fibers 63 disposed inside the hollow shaft portion 50, and is emitted from the distal end of the shaft portion 50. Is done. A desired observation site or the like is illuminated by light emitted from the distal end of the shaft portion 50, and an image of the observation site is obtained by receiving the reflected light with an imaging device included in the C-MOS camera 65. It becomes possible.

As described above, the light emitted from the LED 61 is transmitted to the plurality of optical fibers 63 to form one irradiation light, and the distal end of the optical fiber 63 is connected to the C-MOS camera 65. It is desirable that a plurality of C-MOS cameras 65 and / or an objective lens (not shown) included in the C-MOS camera 65 be arranged around the periphery so as to be substantially parallel to the optical axis. As a result, the light from the light source can be uniformly irradiated to the observation site, and as a result, a wider range of the field of view obtained from the C-MOS camera 65 can be sufficiently illuminated, and a clearer image can be obtained to obtain the observation site. Can be confirmed more reliably.

As described in detail, the endoscope apparatus L1 used in the pericardial puncture device 1 of the present invention includes a light source that is separately provided in a conventional endoscope, a C-MOS camera 65 such as an optical camera, and the like. Are integrated after being reduced in size and weight, enabling the configuration of the endoscope apparatus L1 having a very small diameter of 2.0 mm. As described above, in the forceps 10 used in the pericardial puncture device 1 of the present invention, the outer diameter of the shaft 16 constituting the forceps 10 and the open / close arm member 26 in the closed state are both 1.0 mm. Therefore, the diameter is very small compared to conventional forceps. Therefore, the pericardial puncture device 1 of the present invention is configured using the small-diameter endoscope apparatus L1 and the forceps 10, thereby realizing an ultra-fine device having a diameter of 3.5 mm. Yes. The surgeon grasped the pericardium using the forceps 10 and used the puncture needle 12 while visually recognizing the pericardial space from a clear image taken in real time using the pericardial puncture device 1. The pericardial puncture can be reliably performed.

《Explanation of treatment》
Next, a method for performing pericardial puncture using the pericardial puncture device 1 of the present invention will be described with reference to FIGS. 7 (a), (b), (c) and FIGS. 8 (a), (b). To do. 7 (a), 7 (b), and 7 (c) are schematic views showing steps from incising the patient's sternum to inserting the pericardial puncture device 1 of the present invention into the pericardium. (A), (b) is the schematic diagram explaining the procedure which punctures a pericardium using the pericardial puncture device 1 of this invention.

First, as shown in FIG. 7 (a), the practitioner incises the lower part of the patient's sternum 74, and inserts a metal guide wire 73 into the patient's chest through the hole in the chest provided by the incision. The distal tip of the guide wire 73 is made to reach the vicinity of the patient's pericardial membrane 75 while avoiding the diaphragm 77, and then left in place.

Next, the practitioner inserts the proximal end of the guide wire 73 inserted from the patient's chest into the sheath 79 from the distal side of the hard resin sheath 79, and the distal side of the sheath 79 is inserted into the patient's chest. Insert inside. Next, after the distal tip of the inserted sheath 79 is placed in the vicinity of the patient's pericardium 75 along the guide wire 73 and placed, the guide wire 73 is moved from the chest of the patient to the operator side. Remove completely (see FIG. 7B).

Subsequently, as shown in FIG. 7 (c), the practitioner operates the device of the pericardial puncture device 1 of the present invention from the proximal end of the hard resin sheath 79 inserted into the chest of the patient by the previous step. The insertion portion E2 is inserted into the sheath 79. Next, after the pericardial puncture device 1 is penetrated into the patient's chest through the inside of the sheath 79, the distal tip of the pericardial puncture device 1 is made to reach the distal tip of the sheath 79, Indwelling near the pericardial membrane 75.

Next, the practitioner inserts the open / close arm member 26 side of the forceps 10 through the forceps hole H1 provided at the proximal end of the pericardial puncture device 1 and inserts it into the forceps insertion channel E4. After allowing the forceps 10 to enter the chest of the patient through the forceps insertion channel E4, the open / close arm member 26 of the forceps 10 reaches the distal forceps opening H2 provided at the distal tip of the pericardial puncture device 1. Let Next, the practitioner activates the endoscopic device L1 provided at the distal end of the sac puncture device 1, and confirms the image captured by the endoscopic device L1 while holding the pericardial membrane 75 of the patient with the forceps 10. After opening and closing the open / close arm member 26, the state is pulled toward the proximal side. (See FIG. 8 (a)).

Subsequently, as shown in FIG. 8 (b), the practitioner inserts the distal end side of the puncture needle 12 through the puncture needle hole H4 provided at the proximal end of the pericardial puncture device 1, and the puncture needle Insert into the insertion channel E5. After the puncture needle 12 has entered the patient's chest through the inside of the puncture needle insertion channel E5, the tip of the puncture needle 12 reaches the distal puncture needle port H3 provided at the distal tip of the pericardial puncture device 1. To reach. Next, the patient's pericardium 75 is punctured using the forceps 10 in the previous step while confirming the image captured by the endoscope apparatus L1 provided at the distal tip of the pericardial puncture device 1. .

When the pericardial fluid is small after puncturing, the puncture needle 12 is completely removed from the puncture needle insertion channel E5 to the operator side, and a syringe (not shown) is attached to the puncture needle hole H4. Using the puncture needle insertion channel E5 that has become hollow, the pericardial effusion accumulated inside the pericardium is sucked from the distal puncture needle port H3, and the puncture needle insertion channel E5 is inserted from the proximal side of the puncture needle insertion channel E5. It will be drained out of the patient's body. If the pericardial fluid is large, the guide wire 73 is inserted into the patient's chest again to reach the distal tip to the vicinity of the pericardial membrane 75, and then the pericardial puncture device 1 is attached to the patient. It is removed from the body and the distal tip of a drainage kit (not shown) is inserted along the guide wire 73 to the vicinity of the pericardial membrane 75. Next, the pericardial effusion accumulated inside the pericardium is sucked from the distal tip of the inserted drainage kit, discharged from the patient's body from the proximal side of the drainage kit, and the pericardial sac using the pericardial puncture device 1 of the present invention The membrane puncture will be completed.

The forceps insertion channel E4 and the puncture needle insertion channel E5 of the pericardial puncture device 1 of the present invention also serve as versatile channels, and the patient can use the two channels at the time of pericardial puncture or after pericardial puncture. These two channels are used for various purposes, such as inserting or removing the tip of the instrument necessary for external ablation using the forceps insertion channel E4 and the puncture needle insertion channel E5. Is possible.

As mentioned above, although the embodiment in the pericardial puncture device of this invention was described, this invention is not limited to this, In the range which does not deviate from the mind and teaching as described in a claim, a description, etc. Those skilled in the art will understand that other variations and improvements can be obtained.

DESCRIPTION OF SYMBOLS 1 Pericardial puncture device 2 Lumen shaft 10 Forceps 12 Puncture needle 14 Hand operation part 16 Shaft 18 Forceps part 20 Grip part 21 Body part 22 Operation switch part 23 Fixing pin 24 Operation shaft 26 Opening / closing arm member 30 Pivoting pin 32 Connection board 34 pivot pin 36 pivot pin 40 sawtooth 50 shaft portion 56 slide portion 57 illumination means 60 cable 61 LED
63 Optical fiber 65 C-MOS camera 67 Tube 69 Dust-proof cover 71 Signal cable 73 Guide wire 74 Sternum 75 Pericardium 77 Diaphragm 79 Sheath E1 Device gripping part E2 Device insertion part E3 Endoscope processor E4 Forceps insertion channel E5 Puncture needle insertion Channel H1 Forceps hole H2 Tip side forceps port H3 Tip side puncture needle port H4 Puncture needle hole L1 Endoscope device K1 Forceps (1)
K2 forceps (2)
K3 forceps (3)
K4 forceps (4)
K5 forceps (5)
K6 forceps (6)
K7 forceps (7)
K8 forceps (8)
K9 Forceps (9)
K10 Forceps (10)
K11 Forceps (11)

Claims (7)

A lumen shaft having at least three hollow channels;
An illumination means for irradiating the pericardium with light from a light source;
Imaging means for imaging the pericardium irradiated by the illumination means;
Forceps for gripping the pericardium,
A puncture needle that punctures the pericardium grasped by the forceps;
A hollow, hard sheath member that covers the lumen shaft around its axis,
The imaging means and / or the illumination means, the forceps, and the puncture needle are inserted into separate channels, respectively.
The forceps and the puncture needle can be inserted into and removed from the respective channels and protruded to the distal tip of the channel,
The pericardial puncture device for puncturing the pericardial membrane, wherein the imaging means is fixed in the channel. The forceps are coupled to the shaft longer than between both ends of the channel, the proximal operation portion coupled to the proximal end portion of the shaft, and the distal end portion of the shaft, and are opened and closed by operating the gripping portion. It is composed of an arm member that can grip and pull the pericardium,
The pericardial puncture device according to claim 1, wherein the arm member is retractable in the channel in a closed state and has a gripping force required for predetermined pericardial traction of the pericardium. . The imaging means is a C-MOS camera, and the illumination means is an optical fiber,
The pericardial puncture device according to claim 1 or 2, wherein the C-MOS camera and the optical fiber are fixedly arranged in parallel in the same channel. The pericardial puncture device according to any one of claims 1 to 3, wherein the lumen shaft has a diameter of approximately 3 mm. The optical axis of the radiated light from the imaging means and the direction in which the puncture needle and the forceps protrude from the lumen shaft are substantially parallel to each other. A pericardial puncture device according to claim 1. At the distal tip of the C-MOS camera and optical fiber, a lens member is provided,
The diffusivity of light from the optical fiber through the lens member is greater than or equal to a viewing angle at a focal position in the C-MOS camera through the lens member. The pericardial puncture device according to any one of 3 to 5. The viewing angle of the C-MOS camera is 100 °,
The pericardial puncture device according to any one of claims 3 to 6.