Percutaneous solid organ puncture channel plugging device

Abstract

The invention relates to the technical field of medical instruments, and discloses a percutaneous solid organ puncture channel plugging device which comprises a sleeve, an inner core and a pushing rod, a hollow channel is formed in the sleeve in the axial direction of the sleeve, the inner core is made of a gelatin sponge strip and preset at the far end of the hollow channel, the pushing rod is movably connected with the sleeve, and the pushing rod is movably connected with the sleeve. The pushing rod can be inserted into the hollow channel through the near end of the sleeve to push the inner core out of the sleeve. According to the percutaneous solid organ puncture channel plugging device, the design that the sleeve carries the gelatin sponge strip inner core is adopted, the plugging device can be conveniently pushed to the deep part of a puncture channel along a puncture needle sleeve or a sheathing canal, the inner core is ejected out through the pushing rod, and the whole-course plugging effect is achieved.

Description

Technical Field

[0001] The present invention relates to the technical field of medical devices, and in particular to a percutaneous solid organ puncture tract blocking device. Background Art

[0002] Interventional therapy is a method of placing special medical devices into specific parts of the human body for disease diagnosis and treatment under the guidance of medical imaging equipment. Percutaneous puncture is the basis of interventional therapy, and its purpose is to establish channels (including vascular and non-vascular channels) to complete the subsequent diagnosis or treatment process. In recent years, percutaneous puncture biopsy of organs (such as liver, spleen, kidney, etc.), percutaneous puncture local tumor treatment (such as radiofrequency ablation, chemical ablation, radioactive particle implantation, etc.) and percutaneous puncture catheter interventional treatment (such as portal vein branch embolization, portal vein thrombolysis, local perfusion chemotherapy, hepatic vein opening, etc.) have been increasingly widely used in clinical practice and developed rapidly. Taking puncture biopsy as an example, puncture biopsy is the main way to obtain pathological diagnosis. Case analysis of tumor tissue is an indispensable part of the tumor treatment process and plays a key role in the formulation of treatment plans.

[0003] After percutaneous interventional procedures such as biopsy, drainage, ablation or puncture of blood vessels through solid organs, cavities will be left in the puncture path (mainly inside the punctured organ). When a thinner needle is used for puncture, physical compression can stop bleeding, but when a thicker puncture needle or sheath is used, it is necessary to block the puncture path to prevent bleeding. At present, in clinical practice, when the risk of bleeding in the puncture channel is assessed to be high, granular or flocculent gelatin sponge is mixed with normal saline and filled through the puncture needle cover or sheath in order to block the puncture path. Gelatin sponge is a degradable substance that generally degrades in about 2-3 weeks. However, for gelatin sponge particle embolization, the gelatin sponge will quickly soften after contact with liquid, the fluidity of the suspension is too large, and the filling effect on the puncture path is not ideal. After the injection is completed, there is also a risk of displacement of gelatin. In cases where the puncture channel is larger, metal spring coils or vascular plugs are often used to embolize the puncture channel; metal spring coils and vascular plugs are only suitable for larger puncture channels, otherwise the metal spring coils cannot be coiled up in the thin puncture channel to restore their shape, and this type of material cannot be removed after embolization and will not degrade, which may affect future re-operations and imaging examinations.

[0004] Currently, there is no device specifically designed for percutaneous embolization of solid organ puncture channels. Summary of the invention

[0005] In order to address the deficiencies in the above-mentioned prior art, the present invention provides a percutaneous solid organ puncture tract occlusion device, which can safely, conveniently and efficiently complete the puncture tract occlusion after establishing a percutaneous interventional access, effectively treat a small amount of bleeding in the puncture tract, reduce or eliminate the risk of secondary bleeding and major bleeding, thereby improving the safety of related operations and reducing the incidence of related adverse events.

[0006] In order to achieve the above technical purpose, the technical solution adopted by the present invention is: A percutaneous solid organ puncture tract blocking device comprises a sleeve, an inner core and a push rod. The sleeve is provided with a hollow channel along its axial direction. The inner core is made of a gelatin sponge strip and is preset at the distal end of the hollow channel. The push rod is movably connected to the sleeve. The push rod can be inserted into the hollow channel through the proximal end of the sleeve to push the inner core out of the sleeve.

[0007] As a preferred technical solution, the sleeve is in the shape of a thin-walled cylinder, the push rod is in the shape of a solid cylinder, and the outer diameter of the push rod is equivalent to the diameter of the hollow channel of the sleeve.

[0008] As a preferred technical solution, the proximal end of the sleeve is integrally formed with a base, a guide channel is provided in the base, the guide channel is wedge-shaped, the end of the guide channel is connected to the hollow channel, and the inner diameter of the end of the guide channel is adapted to the diameter of the hollow channel.

[0009] As a preferred technical solution, a handle is provided at the proximal end of the push rod, and the outer diameter of the handle is larger than the inner diameter of the inlet end of the guide channel of the sleeve base.

[0010] As a preferred technical solution, the sleeve is made of translucent plastic material.

[0011] As a preferred technical solution, scale lines are provided on the surface of the sleeve.

[0012] As a preferred technical solution, the push rod is made of plastic material.

[0013] As a preferred technical solution, the inner core is made of a spirally compressed gelatin sponge strip and is preset at the distal end of the hollow channel of the sleeve.

[0014] As a preferred technical solution, a hemostatic drug is attached to the surface of the inner core.

[0015] As a preferred technical solution, the length of the sleeve is 16 cm, and the specifications of the sleeve include but are not limited to outer diameters of 1.0 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2.0 mm, 2.2 mm, 2.6 mm, and 3 mm, and the wall thickness is 0.1 mm; the length of the inner core is 10 cm.

[0016] The beneficial effects of the present invention are: The percutaneous solid organ puncture tract blocking device of the present invention adopts a design in which a sleeve carries a gelatin sponge strip inner core, so that the blocking device can be conveniently pushed along the puncture needle sleeve or sheath to the deep part of the puncture channel, and the inner core is pushed out by a pushing rod to achieve a full-course blocking effect.

[0017] The percutaneous solid organ puncture tract blocking device of the present invention has a base disposed at the proximal end of the cannula and a handle disposed at the proximal end of the push rod. The base can prevent the cannula from falling into the puncture needle sleeve or sheath during use, and the handle is convenient for hand-held operation and can prevent the push rod from completely entering the cannula and being unable to be removed when being pushed in the cannula.

[0018] The percutaneous solid organ puncture tract blocking device of the present invention can cut both the sleeve and the inner core of the gelatin sponge strip, so that the length of the gelatin sponge strip can be adjusted in advance according to the depth of the puncture channel so that the puncture channel can be completely embolized without protruding out of the body.

[0019] The percutaneous solid organ puncture tract blocking device of the present invention adopts a method of mixing a gelatin sponge strip with a hemostatic drug, which can further improve the hemostatic effect.

[0020] The percutaneous solid organ puncture tract occlusion device of the present invention is mainly used to establish pathways for various percutaneous interventional techniques for various organs or lesions and to occlude the puncture tract after the operation is completed, including but not limited to puncture biopsy, ablation treatment, establishment of pathways for vascular interventional treatment, etc. of the liver, kidneys, lungs, spleen, and lymph nodes; the sheath and the inner core have specifications of different diameters to meet the needs of filling puncture channels of different sizes; the whole set of devices has a wide range of material sources, low cost, and simple preparation, can achieve good economic and social benefits, and has broad application prospects. BRIEF DESCRIPTION OF THE DRAWINGS

[0021] In order to more clearly illustrate the technical solutions of the embodiments of the present application, the drawings required for use in the embodiments will be briefly introduced below. It should be understood that the following drawings only show certain embodiments of the present application and therefore should not be regarded as limiting the scope. For ordinary technicians in this field, other related drawings can be obtained based on these drawings without paying creative work.

[0022] Figure 1 is a schematic diagram of the overall structure of an embodiment of the present invention; Figure 2 is a cross-sectional schematic diagram of the casing and the inner core; Figure 3 It is a schematic diagram of the appearance of the casing; Figure 4 It is a schematic diagram of the structure of the push rod; Figure 5 It is a schematic diagram of an embodiment of the present invention in an application state.

[0023] Figure numerals: 1-cannula, 2-inner core, 3-base, 4-scale line, 5-guide channel, 6-push rod, 7-handle, 8-puncture needle sleeve or sheath. DETAILED DESCRIPTION

[0024] To make the purpose, technical scheme and advantages of the embodiments of the present application clearer, the technical scheme in the embodiments of the present application will be clearly and completely described below in conjunction with the drawings in the embodiments of the present application. Obviously, the described embodiments are part of the embodiments of the present application, rather than all of the embodiments. The components of the embodiments of the present application generally described and shown in the drawings here can be arranged and designed in various different configurations. Therefore, the following detailed description of the embodiments of the present application provided in the drawings is not intended to limit the scope of the application claimed for protection, but merely represents the selected embodiments of the present application. Based on the embodiments in the present application, all other embodiments obtained by ordinary technicians of the art without making creative work are within the scope of protection of the present application.

[0025] A percutaneous solid organ puncture tract occlusion device, such as Figure 1-Figure 4 As shown, it includes a sleeve 1, an inner core 2 and a pushing rod 6. The sleeve 1 is provided with a hollow channel along its axial direction. The inner core 2 is made of a gelatin sponge strip. The inner core 2 is preset at the distal end of the hollow channel. The pushing rod 6 is movably connected to the sleeve 1. The pushing rod 6 can be inserted into the hollow channel through the proximal end of the sleeve 1 to push the inner core 2 out of the sleeve 1.

[0026] Furthermore, the sleeve 1 is in the shape of a thin-walled cylinder and is made of a translucent plastic material. A base 3 is integrally formed at the proximal end of the sleeve 1, and a guide channel 5 is arranged in the base 3. The guide channel 5 is in the shape of a wedge, and the end of the guide channel 5 is connected to the hollow channel. The inner diameter of the end of the guide channel 5 is adapted to the outer diameter of the distal end of the push rod 6, which is convenient for the insertion of the push rod 6. At the same time, the base 3 can prevent the sleeve 1 from falling into the puncture tract or the sheath in the puncture tract during use. Preferably, the push rod 6 is in the shape of a solid cylinder and is made of a plastic material. A handle 7 is provided at the proximal end of the push rod 6, and the outer diameter of the handle 7 is larger than the inner diameter of the entrance end of the sleeve base guide channel 5. The handle 7 is provided to facilitate hand-held operation and to avoid the situation where the push rod 6 completely enters the sleeve 1 and cannot be removed when being pushed in the sleeve 1.

[0027] The inner core 2 is made of a spirally compressed gelatin sponge strip and is preset at the distal end of the hollow channel of the cannula. Preferably, a hemostatic drug, such as thrombin, is attached to the surface of the inner core 2. The gelatin sponge strip is a compressible, absorbable and easily degradable material that can swell when exposed to liquid. After being pushed out of the cannula by the push rod, it can completely block the puncture path by its own expansion. It is usually completely degraded in about 2-3 weeks, and has no effect on subsequent imaging examinations such as CT, MRI and treatment; the hemostatic drug attached to the surface can further increase the hemostatic effect.

[0028] In a specific embodiment, the sleeve 1 is 16 cm long, including 14 cm in the solid organ puncture channel (generally, the length of the puncture needle sleeve or sheath does not exceed 14 cm) and 2 cm in the base portion. There are scale lines 4 with units of 1 cm on the surface of the sleeve, which are convenient for clarifying the depth of insertion into the puncture channel during operation. The length of the sleeve is fixed, and multiple specifications are preset according to different diameters. Its wall thickness is 0.1 mm, so the inner diameter is 0.2 mm smaller than the outer diameter. The preset specifications of the sleeve include but are not limited to outer diameters of 1.0 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2.0 mm, 2.2 mm, 2.6 mm, and 3 mm, which are respectively suitable for using 18G puncture needles, 17G puncture needles, 16G puncture needles or 4F sheaths, 15G puncture needles or 5F sheaths, 14G puncture needles, 6F sheaths, 7F sheaths, 8F sheaths, and 9F sheaths. The present invention is applicable to the case where the outer diameter of the puncture needle sleeve or sheath is greater than 1.2 mm (i.e., using an 18G or higher puncture needle or inserting a 4F or higher sheath).

[0029] The front section of the push rod 6 is 16 cm long (equivalent to the length of the sleeve), and the handle is 2 cm long. The diameter of the front section of the push rod 6 is equivalent to the inner diameter of the sleeve 1 and the diameter of the inner core 2, and the preset specifications are 0.8 cm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2.0 mm, 2.4 mm, and 2.8 mm; the handle diameter is 3.2 mm.

[0030] The inner core 2 (i.e. the compressed gelatin sponge strip) is 10 cm long and has a diameter equal to the inner diameter of the above-mentioned sleeve (i.e. the outer diameter minus the wall thickness, which is 0.2 mm smaller than the outer diameter). The preset specifications are 0.8 cm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2.0 mm, 2.4 mm, and 2.8 mm (the diameter is the size of the compressed gelatin sponge strip). It is expected that the diameter can increase to 3-4 times after self-expansion.

[0031] The method of using the device of the present invention is as follows: Figure 5As shown, after the interventional operation is completed, the puncture needle sleeve or sheath 8 is left in the puncture channel. The length of the puncture needle sleeve or sheath 8 left in the body (i.e., the length of the puncture channel) is determined to be equal to the required length of the inner core 2. First, insert the cannula 1 along the base 3 with the push rod 6 in vitro, and slowly push out the inner core 2 in the cannula 1. The pushed length is the length of the excess inner core 2 (for example, if the puncture channel length is 7cm, the inner core is 10-7=3cm excess). The length of the inner core retained in the cannula is determined in real time according to the scale on the cannula 1. Cut the excess inner core pushed out with sterile scissors or blades; then insert the cannula containing the remaining inner core into the puncture needle sleeve or sheath 8 until the front end of the cannula 1 coincides with the front end of the puncture needle sleeve or sheath 8 (i.e., reaches the frontmost point of the puncture channel). Insert the push rod 6 into the cannula 1 along the cannula base 3 until it contacts the inner core 2 (resistance can be felt). At this time, the front end of the push rod 6 is just pushed to the body surface, and the inner core 2 is completely located in the body. Keep the push rod 6 in a fixed position relative to the patient's body surface, and slowly withdraw the puncture needle cover or sheath 8 and cannula 1 at the same time until they are completely withdrawn from the body surface. During this process, the inner core 2 is released and expanded in the puncture channel, and after the other devices are withdrawn, the inner core 2 can completely block the puncture channel.

[0032] Of course, the present invention may have many other embodiments. Without departing from the spirit and essence of the present invention, technicians familiar with the field may make various corresponding changes and deformations based on the present invention, but these corresponding changes and deformations should all fall within the scope of protection of the claims attached to the present invention.

Claims

1. A percutaneous solid organ puncture tract occlusion device, characterized in that: It includes a sleeve, an inner core and a push rod. The sleeve is provided with a hollow channel along its axial direction. The inner core is made of a gelatin sponge strip. The inner core is preset at the distal end of the hollow channel. The push rod is movably connected to the sleeve. The push rod can be inserted into the hollow channel through the proximal end of the sleeve to push the inner core out of the sleeve.

2. The percutaneous solid organ puncture tract occlusion device according to claim 1, characterized in that: The sleeve is in the shape of a thin-walled cylinder, the push rod is in the shape of a solid cylinder, and the outer diameter of the push rod is equivalent to the diameter of the hollow channel of the sleeve.

3. The percutaneous solid organ puncture tract occlusion device according to claim 2, characterized in that: The proximal end of the sleeve is integrally formed with a base, and a guide channel is arranged in the base. The guide channel is wedge-shaped, and the end of the guide channel is connected to the hollow channel. The inner diameter of the end of the guide channel is adapted to the diameter of the hollow channel.

4. The percutaneous solid organ puncture tract occlusion device according to claim 3, characterized in that: A handle is provided at the proximal end of the pushing rod, and the outer diameter of the handle is larger than the inner diameter of the inlet end of the guide channel of the sleeve base.

5. The percutaneous solid organ puncture tract occlusion device according to claim 1, characterized in that: The sleeve is made of translucent plastic material.

6. The percutaneous solid organ puncture tract occlusion device according to claim 5, characterized in that: The surface of the sleeve is provided with scale lines.

7. The percutaneous solid organ puncture tract occlusion device according to claim 1, characterized in that: The pushing rod is made of plastic material.

8. The percutaneous solid organ puncture tract occlusion device according to claim 1, characterized in that: The inner core is pre-set at the far end of the hollow channel of the sleeve after spiral compression of a gelatin sponge strip.

9. The percutaneous solid organ puncture tract occlusion device according to claim 8, characterized in that: The surface of the inner core is attached with hemostatic drugs.

10. The percutaneous solid organ puncture tract occlusion device according to claim 1, characterized in that: The length of the sleeve is 16 cm, and the specifications of the sleeve include but are not limited to outer diameters of 1.0 mm, 1.2 mm, 1.4 mm, 1.6 mm, 1.8 mm, 2.0 mm, 2.2 mm, 2.6 mm, and 3 mm, and the wall thickness is 0.1 mm; the length of the inner core is 10 cm.

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