Pericardium puncture device

Abstract

The invention belongs to the technical field of pericardiocentesis, and discloses a pericardiocentesis device which comprises a drainage main pipe, a supporting inner core, a puncture needle and a puncture guide wire, the supporting inner core is arranged in the drainage main pipe in a penetrating mode, the outer diameter of the supporting inner core is matched with the inner diameter of the drainage main pipe, the puncture needle is arranged in the supporting inner core in a penetrating mode, and a hollow cavity channel is formed in the puncture needle. A puncture guide wire is arranged in the hollow cavity channel in a penetrating mode, the puncture guide wire is in a J shape in an unstressed state, the puncture guide wire comprises a pointed end section, a bent section, a supporting section and a hard section, and developing marks are arranged at the pointed end section, the puncture end of the puncture needle and the puncture end of the drainage main pipe. The drainage main pipe is supported through the supporting inner core, and the strength of the drainage main pipe is improved; the skin and subcutaneous tissue of a patient can be easily punctured through the puncture needle, the outer layer of the pericardial cavity is punctured through the puncture guide wire and enters the pericardial cavity, the bent section forms a J shape in the pericardial cavity, the contact probability of the needle tip and the non-punctured part and the myocardial is reduced, and the safety of puncture operation is improved.

Description

TECHNICAL FIELD

[0001] The present application relates to the technical field of pericardiocentesis, in particular to a pericardiocentesis device. BACKGROUND

[0002] The pericardium is a double-membrane structure composed of fibrous pericardium (outer layer) and serous pericardium (inner layer), which tightly wraps the heart and the root of large blood vessels, and has the functions of fixing the position of the heart, preventing excessive expansion, and providing lubrication protection. The potential space (pericardial cavity) is formed between the visceral layer and the parietal layer of the serous pericardium, and contains a small amount of serous fluid (<50 ml) under normal circumstances. In pathological conditions such as infection, tumor, heart failure, and hypoproteinemia, pericardial effusion may occur, which requires puncture and drainage for diagnosis or to alleviate the symptoms of cardiac compression. In addition, during cardiac interventional surgery, the heart or cardiac blood vessels may be ruptured due to various reasons, causing acute cardiac tamponade, which requires emergency pericardiocentesis to save the patient's life. At the same time, with the development of epicardial radiofrequency ablation surgery, dry pericardiocentesis is needed to establish an epicardial channel. However, the current pericardiocentesis technique has a long learning curve, is difficult to learn, has high risk and difficulty, and is limited in its widespread application.

[0003] A pericardiocentesis needle with the application number CN202210898174.9 is disclosed, which includes a guide assembly, a puncture assembly, a positioning pacing assembly, and a three-dimensional modeling assembly. The puncture assembly is used for puncture, and the pacing assembly is used for pacing simultaneously. However, the puncture process of the pericardiocentesis needle and the puncture process of the existing pericardiocentesis tool are both performed by using a single metal puncture needle. In the actual clinical operation process, the drainage tube is too thin and soft, making it difficult to perform puncture operation. At the same time, the puncture needle is straight and enters the pericardium, and the puncture is too deep, which may damage the heart, even enter the heart cavity, causing damage to the heart, and in severe cases, endangering the patient's life. Therefore, there is an urgent need for a pericardiocentesis device to assist the operator to better perform puncture operation and avoid excessive damage to the patient's heart. SUMMARY

[0004] The present application aims to provide a pericardiocentesis device to solve the problem that the current pericardiocentesis device is not convenient to operate and is prone to cause collateral damage.

[0005] In order to achieve the above-mentioned purpose, the present application provides the following technical solutions:

[0006] The application discloses a pericardial puncture device which comprises a drainage main pipe, a supporting inner core, a puncture needle and a puncture guide wire, the operation end of the drainage main pipe is provided with a female connector, the female connector is matched with a male connector, the male connector is arranged on the supporting inner core, the supporting inner core is arranged in the drainage main pipe and the outer diameter of the supporting inner core is matched with the inner diameter of the drainage main pipe, the operation end of the drainage main pipe and the supporting inner core is provided with an auxiliary handle, the puncture needle is arranged in the supporting inner core, a hollow cavity is formed in the puncture needle, the puncture guide wire is arranged in the hollow cavity, the puncture guide wire is in a J shape under a non-stressed state, the puncture guide wire comprises a sharp head section, a bending section, a supporting section and a hard section, the outer diameter of the hard section is the same as the outer diameter of the puncture needle, one end of the hard section is connected with the supporting section, the other end of the supporting section is connected with one end of the bending section, the other end of the bending section is connected with the sharp head section, and the sharp head section, the puncture end of the puncture needle and the puncture end of the drainage main pipe are all provided with a developing mark.

[0007] Further, two groups of clamping assemblies are arranged on the auxiliary handle, one group of the clamping assemblies is clamped and fixed on the drainage main pipe, and the other group of the clamping assemblies is clamped and fixed on the puncture needle, the clamping assembly comprises a fixed clamping block and a movable clamping block, the fixed clamping block is arranged on the auxiliary handle, the movable clamping block is slidingly arranged in a sliding groove on the auxiliary handle, a compression spring is arranged between the bottom surface of the movable clamping block and the auxiliary handle, a push rod is arranged on the top surface of the movable clamping block, and the top end of the push rod penetrates through the top surface of the auxiliary handle.

[0008] Further, a first semicircular groove and a second semicircular groove are respectively arranged on the movable clamping block and the fixed clamping block of one group of the clamping assemblies, the inner diameter of the first semicircular groove is the same as the outer diameter of the supporting inner core, and the inner diameter of the second semicircular groove is the same as the outer diameter of the puncture needle and the hard section.

[0009] Further, the puncture end of the puncture needle penetrates out of the supporting inner core, the puncture end of the supporting inner core penetrates out of the drainage main pipe, the puncture end of the supporting inner core and the puncture end of the drainage main pipe are both in a conical shape, and the puncture end of the drainage main pipe is in a natural curling state under a non-stressed condition.

[0010] Further, the puncture needle and the puncture guide wire are both made of stainless steel, and the developing mark is made of platinum-iridium alloy.

[0011] The principle and beneficial effects of the technical scheme are as follows:

[0012] The application provides a pericardium puncture device, which supports a drainage main pipe through a supporting inner core, improves the strength of the drainage main pipe, and enables the drainage main pipe to better enter the patient's subcutaneous tissue along with a puncture needle, so that the puncture is smooth, and the drainage main pipe is not too soft to cause the puncture to be not smooth during operation; the puncture guide wire is taken out from the puncture needle, the patient's skin and subcutaneous tissue are easily punctured through the puncture needle under the guidance of DSA, a section of puncture is performed, the puncture is stopped after reaching the outside of the pericardium cavity, the puncture needle does not enter the pericardium cavity, then the supporting inner core and the drainage main pipe cover the needle tip of the puncture needle, reach the outside of the pericardium cavity, the puncture needle is withdrawn from the supporting inner core, then the puncture guide wire is replaced, the puncture guide wire is sent to the tip of the supporting inner core, the puncture guide wire is pushed, so that the sharp head section and the curved section are stretched out of the supporting inner core, the sharp head section punctures the outer layer of the pericardium cavity, and thus enters the pericardium cavity, the puncture guide wire is continuously pushed, so that the curved section enters the pericardium cavity along with the sharp head section, the curved section restores the curved state after losing the limitation of the inner wall of the supporting inner core, forms a J-shaped structure, and drives the sharp head section to be rolled up, so that the sharp head section does not contact the non-puncture area after the puncture guide wire is deeply inserted, and the heart is not damaged, after the guide wire is placed in position, the drainage main pipe is pushed along the guide wire path and enters the pericardium cavity, two sections of layered puncture are performed through the puncture needle and the J-shaped puncture guide wire, the traditional single puncture needle is replaced by the straight puncture mode, the probability that the sharp needle tip structure contacts the non-puncture part of the pericardium and the myocardium is effectively reduced, the safety of the puncture operation is greatly improved, and the occurrence of complications is reduced. BRIEF DESCRIPTION OF DRAWINGS

[0013] Figure 1 It is a structural schematic diagram of the pericardium puncture device.

[0014] Figure 2 It is an assembly structural schematic diagram of the pericardium puncture device.

[0015] Figure 3 It is Figure 2 It is an enlarged schematic diagram of position A in FIG. 5.

[0016] Figure 4 It is a schematic diagram of the drainage main pipe in the pericardium puncture device in a stress-free state.

[0017] Figure 5 It is a schematic diagram of the puncture guide wire in the pericardium puncture device in a stress-free state.

[0018] Figure 6 It is a sectional view of the puncture end of the pericardium puncture device.

[0019] Figure 7 It is Figure 6 It is an enlarged schematic diagram of position B in FIG. 6.

[0020] Figure 8A sectional view of an operation end and an auxiliary handle of a pericardium puncture device of the present application;

[0021] Figure 9 A first puncture state schematic diagram of a pericardium puncture device of the present application;

[0022] Figure 10 A second puncture state schematic diagram of a pericardium puncture device of the present application;

[0023] Figure 11 A drainage main pipe placement state schematic diagram of a pericardium puncture device of the present application;

[0024] The names of the corresponding marks in the drawings are: 1, drainage main pipe; 101, female joint; 2, support inner core; 201, male joint; 3, puncture needle; 301, hollow cavity; 4, puncture guide wire; 401, sharp head section; 402, curved section; 403, support section; 404, hard section; 5, auxiliary handle; 501, fixed clamping block; 502, movable clamping block; 503, compression spring; 504, push rod; 505, No. 1 semicircular groove; 506, No. 2 semicircular groove; 6, developing mark; 7, pericardium cavity. DETAILED DESCRIPTION

[0025] The present application will be further described in detail below in combination with the drawings and embodiments:

[0026] As Figures 1-11As shown, a pericardial puncture device includes a drainage main pipe 1, a supporting inner core 2, a puncture needle 3 and a puncture guide wire 4. The end of each component entering the human body is the puncture end, and the other end is the operation end. The operation end of the drainage main pipe 1 is provided with a female connector 101. The female connector 101 cooperates with a male connector 201 arranged on the supporting inner core 2. The supporting inner core 2 is fixed in the drainage main pipe 1 through the cooperation of the female connector 101 and the male connector 201, so that the two are combined into a whole, facilitating operation. At the same time, the female connector 101 is a commonly used luer connector in medical devices, which can be directly connected with a corresponding syringe or drainage bag. The supporting inner core 2 is arranged in the drainage main pipe 1, and the outer diameter of the supporting inner core 2 is matched with the inner diameter of the drainage main pipe 1. The drainage main pipe 1 is a 5F flexible tube, which is flexible as a whole. The supporting inner core 2 is also a flexible hollow tube, but has higher hardness than the drainage main pipe 1, providing internal support for the drainage main pipe 1, facilitating subsequent puncture and catheterization. The operation end of the drainage main pipe 1 and the supporting inner core 2 is provided with an auxiliary handle 5. The auxiliary handle 5 can increase the volume of the operation end, facilitating the surgeon to hold and operate. The puncture needle 3 is arranged in the supporting inner core 2. The puncture needle 3 is internally provided with a hollow cavity 301. The hollow cavity 301 enables the surgeon to inject contrast medium through the hollow cavity 301 during placement. If the contrast medium gathers at the tip of the puncture needle 3, it indicates that the puncture needle 3 has not entered the pericardial cavity 7. If the contrast medium dissipates, it indicates that the puncture needle 3 has entered the pericardial cavity 7 with high probability. At this time, careful handling is required. Through this way combined with DSA guided imaging, the accuracy of the surgeon's judgment of the position of the puncture needle 3 is increased. The puncture guide wire 4 is arranged in the hollow cavity 301, and the puncture guide wire 4 is in the shape of J under the state of no stress. The puncture guide wire 4 includes a sharp head section 401, a curved section 402, a supporting section 403 and a hard section 404. The outer diameter of the hard section 404 is the same as that of the puncture needle 3. The hard section 404 is connected with one end of the supporting section 403. One end of the supporting section 403 is connected with one end of the curved section 402. The other end of the curved section 402 is connected with the sharp head section 401. The curved section 402 is a flexible guide wire, which is naturally curved in the initial state. The supporting section 403 is also a flexible guide wire, but has higher hardness, providing support for catheterization. Neither the supporting section 403 nor the curved section 402 can be axially stretched or contracted. The hard section 404 serves as the operation end of the puncture guide wire 4, and cannot be deformed, facilitating subsequent clamping of the clamping assembly.

[0027] In use, the device is taken out of the sterile package, the puncture guide wire 4 is pulled out of the hollow cavity 301 of the puncture needle 3, at this time the support inner core 2 is fixed as a whole with the drainage main pipe 1, and is sleeved outside the puncture needle 3. Under the guidance of DSA, the operator penetrates the skin and subcutaneous tissue of the patient through the puncture needle 3, so that the puncture end of the puncture needle 3 is located outside the pericardium and does not directly puncture into the pericardial cavity 7. The puncture needle 3 is fixed, and the support inner core 2 and the drainage main pipe 1 are pushed to cover the needle tip of the puncture needle 3. At this time, the whole formed by the support inner core 2 and the drainage main pipe 1 is located on one side of the pericardium (first puncture state). Then the whole formed by the support inner core 2 and the drainage main pipe 1 is fixed, and the fixation of the puncture needle 3 is released. The puncture needle 3 is withdrawn and pulled out of the support inner core 2. The puncture guide wire 4 is sent into the support inner core 2, so that the sharp head section 401 reaches the opening at the puncture end of the support inner core 2, the curved section 402 and the support section 403 are completely located in the support inner core 2, and the hard section 404 is inserted into the opening at the operation end of the support inner core 2. The hard section 404 is pushed so that the sharp head section 401 and the curved section 402 stretch out of the opening at the puncture end of the support inner core 2. The sharp head section 401 is pierced into the outer layer of the pericardium and enters the pericardial cavity 7. The hard section 404 is continuously pushed forward so that the curved section 402 enters the pericardial cavity 7 together with the sharp head section 401. When the curved section 402 enters the pericardial cavity 7, it loses the restriction of the inner wall of the support inner core 2 and restores the curved state, thereby forming a J-shaped state in the pericardial cavity 7, winding the sharp head section 401, so that the sharp head section 401 is no longer aligned with the non-puncture site (second puncture state). The probability of contact between the sharp head section 401 and the non-puncture site and myocardium is effectively reduced, the safety of puncture is effectively improved, and the difficulty of puncture operation is reduced to a certain extent. As many puncture guide wires as possible are sent into the pericardial cavity. Under DSA, the puncture guide wire 4 is placed along the shape of the outer edge of the heart and is pushed without obvious resistance. After the puncture guide wire 4 is placed in position, the puncture guide wire 4 and the support inner core 2 are fixed. The operation end of the drainage main pipe 1 is twisted to separate the female connector 101 from the male connector 201 of the support inner core 2, thereby releasing the locking between the drainage main pipe 1 and the support inner core 2. At this time, the drainage main pipe 1 is pushed to enter the pericardial cavity 7 along the path of the puncture guide wire 4, and the puncture end thereof is also wound in the pericardial cavity 7, forming a pigtail-like shape (placement state of the drainage main pipe 1). The end head is prevented from touching the inner wall of the pericardial cavity 7 to cause damage. After the catheterization is completed, the puncture guide wire 4 and the support inner core 2 can be slowly withdrawn. The whole puncture process is performed under the guidance of DSA. The development marks 6 of the sharp head section 401, the puncture end of the puncture needle 3 and the puncture end of the drainage main pipe 1 can be clearly displayed under X-ray irradiation, helping the operator to position and facilitating more accurate puncture operation.

[0028] In the embodiment, two sets of clamping assemblies are arranged on the auxiliary handle 5, one set of clamping assemblies is clamped and fixed on the drainage main pipe 1, and the other set of clamping assemblies is clamped and fixed on the puncture needle 3. The clamping assembly comprises a fixed clamping block 501 and a movable clamping block 502. The fixed clamping block 501 is arranged on the auxiliary handle 5, and the movable clamping block 502 is slidingly arranged in a sliding groove on the auxiliary handle 5. A compression spring 503 is arranged between the bottom surface of the movable clamping block 502 and the auxiliary handle 5. A push rod 504 is arranged on the top surface of the movable clamping block 502, and the top end of the push rod 504 penetrates through the top surface of the auxiliary handle 5. During operation, the operator holds the auxiliary handle 5 and performs one-stage puncture. The operator presses the push rod 504 of the clamping assembly for fixing the puncture needle 3, so that the movable clamping block 502 is separated from the fixed clamping block 501, the locking of the puncture needle 3 is released, and the puncture needle 3 can move relative to the auxiliary handle 5 (at this time, the drainage main pipe 1 and the supporting inner core 2 are fixed as a whole and are fixed by the other set of clamping assemblies and cannot move). The operator only needs to push the puncture needle 3 to perform one-stage puncture. After the puncture needle 3 is punctured to the position, the push rod 504 is released, the movable clamping block 502 rebounds under the action of the compression spring 503, cooperates with the fixed clamping block 501, and clamps and fixes the puncture needle 3 again. At this time, the operator presses the other push rod 504 to release the locking of the drainage main pipe 1, pushes the whole formed by the drainage main pipe 1 and the supporting inner core 2 to the outside of the pericardial cavity 7, releases the push rod 504 to fix it, releases the locking of the puncture needle 3 again, and pulls out the puncture needle 3 to complete one-stage puncture. During the whole process, the operator only needs to hold the auxiliary handle 5 and press or release different push rods 504 to complete the locking and unlocking of the corresponding components, which is simple and convenient to operate.

[0029] In the embodiment, the movable clamping block 502 and the fixed clamping block 501 on one set of clamping assemblies are respectively provided with a first semicircular groove 505 and a second semicircular groove 506. The inner diameter of the first semicircular groove 505 is the same as the outer diameter of the supporting inner core 2, and the inner diameter of the second semicircular groove 506 is the same as the outer diameter of the puncture needle 3 and the hard section 404. Before the puncture guide wire 4 is sent to the supporting inner core 2 to perform two-stage puncture, the two sets of push rods 504 are pressed, and the auxiliary handle 5 is moved to make one set of clamping assemblies located at the end of the operation end of the supporting inner core 2 and clamped and fixed by the first semicircular groove 505. After the puncture guide wire 4 is punctured to the position, the hard section 404 on the puncture guide wire 4 is clamped and fixed by the second semicircular groove 506 on the corresponding movable clamping block 502, so that the puncture guide wire 4 and the supporting inner core 2 are fixed as a whole. The female connector 101 is twisted to release the locking between the drainage main pipe 1 and the supporting inner core 2. The push rod 504 on the other set of clamping assemblies is pressed to release the locking of the auxiliary handle 5 to the drainage main pipe 1. At this time, only the drainage main pipe 1 can move relative to the auxiliary handle 5. The drainage main pipe 1 is pushed to perform catheterization operation, so that the displacement of the supporting inner core 2 and the puncture guide wire 4 is avoided, and the safety of the puncture of the device is effectively improved.

[0030] In the embodiment, the puncture needle 3 puncture end penetrates out of the support inner core 2, the support inner core 2 puncture end penetrates out of the drainage main pipe 1, the support inner core 2 puncture end and the drainage main pipe 1 puncture end are both conical, so that the puncture end of the puncture device is conical as a whole, so as to facilitate better puncture, the drainage main pipe 1 puncture end is in a natural curling state under no force, similar to a pigtail, the pigtail arrangement makes the drainage main pipe 1 keep coiled in the pericardial cavity 7, avoiding damage to the patient by the end.

[0031] In the embodiment, the puncture needle 3 and the puncture guide wire 4 are both made of stainless steel, and the developing mark 6 is made of platinum-iridium alloy. The puncture needle 3 and the puncture guide wire 4 made of stainless steel can absorb a certain X-ray, so they can develop under X-ray, thereby achieving full-length development. The developing mark 6 made of platinum-iridium alloy has higher density, larger atomic number, and stronger X-ray absorption capacity, and will show a darker and clearer high development area on the X-ray image, thereby assisting the operator in positioning the needle tip and other key parts, and more accurately and safely performing puncture operation.

[0032] The above is only an embodiment of the present application, and common technical solutions or characteristics in the scheme are not described in detail. It should be noted that for those skilled in the art, without departing from the technical solutions of the present application, some modifications and improvements can be made, which should also be considered as the protection scope of the present application, and these will not affect the effect and practicality of the present application. The protection scope of the present application should be subject to the content of its claims, and the specific implementation mode and the like in the specification can be used to explain the content of the claims.

Claims

1. A pericardiocentesis device, characterized in that: The device includes a drainage main tube (1), a support inner core (2), a puncture needle (3), and a puncture guide wire (4). The operating end of the drainage main tube (1) is provided with a female connector (101), which mates with a male connector (201). The male connector (201) is located on the support inner core (2). The support inner core (2) is inserted into the drainage main tube (1), and its outer diameter is adapted to the inner diameter of the drainage main tube (1). The operating ends of the drainage main tube (1) and the support inner core (2) are provided with auxiliary handles (5). A puncture needle (3) is inserted into the support inner core (2). A hollow cavity (301) is opened inside the puncture needle (3), and a puncture guide wire (4) is inserted into the hollow cavity (301). The puncture guide wire (4) is J-shaped when not under stress. The puncture guide wire (4) includes a pointed section (401), a curved section (402), a support section (403), and a rigid section (404). The outer diameter of the rigid section (404) is the same as that of the puncture needle (3). The rigid section (404) is connected to one end of the support section (403), and the other end of the support section (403) is connected to one end of the curved section (402). The other end of the curved section (402) is connected to the pointed section (401). The pointed section (401), the puncture end of the puncture needle (3), and the puncture end of the drainage tube (1) are all provided with imaging marks (6).

2. The pericardiocentesis device according to claim 1, characterized in that: The auxiliary handle (5) is provided with two sets of clamping components. One set of clamping components clamps and fixes the main drainage tube (1), and the other set of clamping components clamps and fixes the puncture needle (3). The clamping components include a fixed clamping block (501) and a movable clamping block (502). The fixed clamping block (501) is provided on the auxiliary handle (5), and the movable clamping block (502) is slidably disposed in the groove on the auxiliary handle (5). A compression spring (503) is provided between the bottom surface of the movable clamping block (502) and the auxiliary handle (5). A push rod (504) is provided on the top surface of the movable clamping block (502), and the top end of the push rod (504) protrudes from the top surface of the auxiliary handle (5).

3. The pericardiocentesis device according to claim 2, characterized in that: One set of clamping components has a first semicircular groove (505) and a second semicircular groove (506) respectively on the movable clamping block (502) and the fixed clamping block (501). The inner diameter of the first semicircular groove (505) is the same as the outer diameter of the supporting inner core (2), and the inner diameter of the second semicircular groove (506) is the same as the outer diameter of the puncture needle (3) and the hard segment (404).

4. The pericardiocentesis device according to claim 1, characterized in that: The puncture needle (3) extends out of the support core (2), and the puncture end of the support core (2) extends out of the drainage tube (1). Both the puncture end of the support core (2) and the puncture end of the drainage tube (1) are conical. The puncture end of the drainage tube (1) is naturally curled when not under force.

5. The pericardiocentesis device according to claim 1, characterized in that: The puncture needle (3) and the puncture guide wire (4) are both made of stainless steel, and the imaging marker (6) is made of platinum-iridium alloy.

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