Multi-section gelatin sponge filling type puncture channel plugging device and plugging method thereof

Abstract

The invention discloses a multi-section gelatin sponge filling type puncture channel plugging device and a plugging method thereof.The multi-section gelatin sponge filling type puncture channel plugging device comprises a sleeve which is of a long and thin tubular structure, a cylindrical base is integrally formed at the rear end of the sleeve, a wedge-shaped inlet is formed in the base, and scale marks are arranged on the outer surface of the sleeve; the inner core is formed by sequentially arranging a plurality of sections of independent short columnar medical gelatin sponge units, and the inner core is accommodated in the front section of the cannula; the diameter of the pushing rod is matched with the inner diameter of the sleeve, the pushing rod is inserted into the sleeve, and an expanded handheld part is arranged at the rear end of the pushing rod; according to the scheme, the puncture channel can be safely, conveniently and efficiently blocked after the percutaneous intervention puncture channel is established, a small amount of bleeding of the puncture channel is effectively treated, and the risks of secondary bleeding and massive bleeding are reduced or eradicated, so that the related operation safety is improved, and the occurrence rate of related adverse events is reduced.

Description

Technical Field

[0001] This invention relates to the field of medical device technology, specifically to a multi-segment gelatin sponge-filled puncture channel sealing device and its sealing method. Background Technology

[0002] Interventional therapy, guided by medical imaging equipment, involves inserting specialized medical devices into specific parts of the body for disease diagnosis and treatment. Percutaneous puncture is the foundation of interventional therapy, its purpose being to establish pathways (including vascular and non-vascular pathways) to complete subsequent diagnostic or treatment procedures. In recent years, percutaneous organ biopsy (such as liver, spleen, kidney, etc.), percutaneous local tumor treatment (such as radiofrequency ablation, chemical ablation, radioactive particle implantation, etc.), and percutaneous catheter-based interventional therapy (such as portal vein branch embolization, portal vein thrombolysis, local perfusion chemotherapy, hepatic vein recanalization, etc.) have become increasingly widespread and rapidly developing in clinical practice. Taking biopsy as an example, it is the primary method for obtaining pathological diagnoses, and the analysis of tumor tissue is an indispensable part of tumor treatment, playing a crucial role in the formulation of treatment plans.

[0003] Percutaneous interventional procedures such as biopsies, drainage, ablation, or puncture of blood vessels through solid organs all leave cavities along the puncture route (mainly inside the punctured organ). Although these procedures are minimally invasive, bleeding through the puncture channel remains one of the most significant complications, with a bleeding rate generally ranging from 2% to 10%. In severe cases, it can lead to hemorrhagic shock and even death. When using thinner needles, physical compression can achieve hemostasis. However, when using thicker needles or sheaths, it is necessary to prevent bleeding by sealing the puncture channel. Currently, postoperative sealing of the puncture channel mainly relies on traditional hemostatic materials such as gelatin sponge strips, metal coils, or NBCA medical adhesive. These materials are mostly non-specialized structures, meaning they are used for vascular embolization or surgical hemostasis, and there are currently no standardized disposable instruments specifically for "puncture channel sealing."

[0004] Currently, postoperative closure of puncture sites in clinical practice mainly relies on the following non-specialized materials and methods: 1. Gelatin particle suspension injection method: such as Figure 1 As shown, gelatin sponge is cut into small pieces or commercial granules are used, mixed with physiological saline to form a suspension, and then injected through a sheath. This method has obvious drawbacks: the flow direction of the particles is difficult to control, which can easily lead to non-target embolism; the density of the blockage layer formed is uneven, which can easily cause leakage; the injection volume depends on empirical estimation, which is not reliable enough; and the thin sheath is prone to blockage.

[0005] 2. Homemade gelatin sponge strip sealing method: such as Figure 2As shown, the surgeon manually cuts the gelatin sponge strip according to the estimated puncture depth before the operation, compresses it, and inserts it through the sheath. This method is cumbersome, has a large error in the occlusion length, and the sponge strip is prone to deformation, displacement, or curling during the push process. The occlusion depth cannot be adjusted during the operation. In addition, it lacks standardization and has poor adaptability.

[0006] 3. Metal coil implantation method: such as Figure 3 As shown, this method involves implanting metal coils into the puncture channel, drawing on vascular embolization techniques. However, these devices are often permanent implants that cannot be degraded. Postoperatively, they can produce severe metal artifacts on CT / MRI images, affecting follow-up examinations. There are also risks of foreign body reactions and infection. Furthermore, the method is expensive, complex, and involves overtreatment in most puncture channels.

[0007] In summary, there is currently a lack of a dedicated instrument that can safely, conveniently, efficiently, and in a standardized manner block percutaneous puncture channels; therefore, there is an urgent need for a new blocking device and method that can overcome the above-mentioned deficiencies. Summary of the Invention

[0008] To address the aforementioned shortcomings of existing technologies, this invention provides a multi-segment gelatin sponge-filled puncture channel sealing device and its sealing method, thereby solving the problems of cumbersome sealing operations, poor precision, low reliability, high cost, and the risk of foreign matter residue in existing technologies.

[0009] To achieve the above objectives, the technical solution adopted by the present invention is as follows: In a first aspect, a multi-segment gelatin sponge-filled puncture channel sealing device is provided, comprising: The sleeve is a slender tubular structure. The rear end of the sleeve is integrally formed with a cylindrical base. A wedge-shaped inlet is provided inside the base. The outer surface of the sleeve is provided with scale lines. The inner core is composed of multiple independent short columnar medical gelatin sponge units arranged sequentially, and the inner core is housed inside the front section of the cannula; The push rod has a diameter that matches the inner diameter of the sleeve and is inserted into the sleeve. The rear end of the push rod is provided with an enlarged handle.

[0010] Furthermore, the cannula is made of transparent or translucent medical polymer material.

[0011] Furthermore, the outer diameter of the sleeve is one of 1.0cm, 1.5cm, 2.0cm and 3.0cm.

[0012] Furthermore, the dry length of the medical gelatin sponge unit is 3-8 mm, and its diameter matches the inner diameter of the sleeve.

[0013] Furthermore, the surface of the medical gelatin sponge is coated with thrombin.

[0014] Furthermore, the length of the push rod matches the length of the sleeve, and the front end of the push rod has a blunt end.

[0015] Furthermore, the push rod is made of medical-grade polycarbonate or polypropylene material.

[0016] Secondly, a sealing method for a multi-segment gelatin sponge-filled puncture channel sealing device is provided, which includes the following steps: S1: After the percutaneous interventional procedure is completed, the needle sheath / cannula is left in the puncture channel; S2: Insert the cannula with the inner core pre-installed into the puncture needle sheath / tube until the front end of the cannula coincides with the front end of the puncture needle sheath / tube. S3: Insert the push rod into the sleeve along the wedge-shaped inlet until the front end of the push rod contacts the inner core; S4: Keep the push rod stationary relative to the patient, and withdraw the cannula along with the puncture needle sheath / tube backward until the inner core forms a continuous segmented packing from the deep end to the superficial end in the puncture channel; S5: Remove all instruments, and the indwelling multi-segment medical gelatin sponge unit expands and seals the puncture channel.

[0017] The beneficial effects of this invention are as follows: 1. This solution is highly efficient and convenient to operate: The cannula is pre-loaded with standardized multi-segment medical gelatin sponge units, eliminating the need for preoperative measurement and cutting, reducing the average operation time from 60-90 seconds in the traditional method to 10-30 seconds, improving efficiency by about 70%-80%; moreover, the operation can be completed by a single person with one hand, simplifying the surgical procedure.

[0018] 2. This solution boasts strong hemostatic performance and high safety: The medical gelatin sponge unit can expand to 3-4 times its original volume within 30 seconds in body fluids, thereby generating a stable radial pressure of 25-35 mmHg, effectively stopping bleeding; the segmented medical gelatin sponge unit increases the effective contact area by approximately 40%, enhancing tissue adhesion and coagulation reaction; thrombin can further accelerate clot formation, significantly shortening hemostasis time; simultaneously, due to its segmented structure, even if some medical gelatin sponge units slightly shift due to tissue contraction, the overall sealing layer remains continuous and stable; in addition, the gelatin sponge can be completely degraded in vivo, without forming hard residues, avoiding foreign body reactions.

[0019] 3. The sealing depth of this solution is precisely controllable: The length of each medical gelatin sponge unit is fixed, and the sealing length can be precisely controlled by counting the number of medical gelatin sponge units pushed; at the same time, the segmented release of medical gelatin sponge units achieves continuous and gapless filling from the deep end to the shallow end, effectively avoiding the problems of end cavities and shallow end residues that are prone to occur in traditional whole-strip filling; in addition, the mutual adhesion and micro-friction between each medical gelatin sponge unit form a multi-point anchoring structure, which can maintain good sealing stability in the body fluid environment.

[0020] 4. This solution is highly scalable: This solution consists only of gelatin sponge and plastic components, with a simple structure and low production cost, which is far lower than that of metal spring coils, making it suitable for widespread clinical application. Attached Figure Description

[0021] To more clearly illustrate the technical solutions in the embodiments of the present invention or the prior art, the drawings used in the embodiments will be briefly described below. Obviously, the drawings described below are only some embodiments of the present invention. For those skilled in the art, other drawings can be obtained based on these drawings without creative effort. The above and other objects, features, and advantages of the present invention will become clearer through the accompanying drawings. The same reference numerals indicate the same parts in all the drawings. The drawings are not intentionally drawn to scale to actual dimensions; the focus is on illustrating the main points of the invention.

[0022] Figure 1 This is a schematic diagram of the structure of the gelatin particle suspension injection method in the background art.

[0023] Figure 2 This is a schematic diagram of the structure of the self-made gelatin sponge strip sealing method in the background art.

[0024] Figure 3 This is a schematic diagram of the metal spring coil implantation method in the background art.

[0025] Figure 4 This is a schematic diagram of a multi-segment gelatin sponge-filled puncture channel sealing device.

[0026] Figure 5 This is a schematic diagram of the casing structure.

[0027] Figure 6 This is a schematic diagram of the internal structure of the casing.

[0028] Figure 7 This is a schematic diagram of the push rod structure.

[0029] The components are: 1. Sleeve, 2. Inner core, 3. Base, 4. Scale line, 5. Wedge-shaped inlet, 6. Push rod, and 7. Handheld part. Detailed Implementation

[0030] To make the objectives, technical solutions, and advantages of the embodiments of the present invention clearer, the technical solutions of the embodiments of the present invention will be clearly and completely described below with reference to the accompanying drawings. Obviously, the described embodiments are only some embodiments of the present invention, and not all embodiments. The components of the embodiments of the present invention described and shown in the accompanying drawings can generally be arranged and designed in various different configurations.

[0031] Therefore, the following detailed description of the embodiments of the invention provided in the accompanying drawings is not intended to limit the scope of the claimed invention, but merely to illustrate selected embodiments of the invention. All other embodiments obtained by those skilled in the art based on the embodiments of the invention without inventive effort are within the scope of protection of the invention.

[0032] It should be noted that similar labels and letters in the following figures indicate similar items. Therefore, once an item is defined in one figure, it does not need to be further defined and explained in subsequent figures.

[0033] Furthermore, the terms "first," "second," etc., are used only to distinguish descriptions and should not be interpreted as indicating or implying relative importance.

[0034] This multi-segment gelatin sponge-filled puncture channel occlusion device is mainly used to occlude puncture channels after various percutaneous puncture interventional procedures for various organs or lesions. It is widely applicable to hemostasis and occlusion of puncture channels after percutaneous liver, kidney, lung, spleen, lymph node biopsies or ablation.

[0035] like Figures 4 to 7 As shown, the multi-segment gelatin sponge-filled puncture channel sealing device of this scheme includes a sleeve 1, an inner core 2, and a push rod 6.

[0036] The cannula 1 is a slender tubular structure made of transparent or translucent medical polymer material, preferably polypropylene, polyethylene, or polyurethane. The rear end of the cannula 1 is integrally formed with a cylindrical base 3, and a wedge-shaped inlet 5 is provided inside the base 3. The outer surface of the cannula 1 is provided with graduation lines 4 in units of 1 cm to facilitate clear insertion depth into the puncture channel during operation. The length of the cannula 1 is 14 cm, the length of the base 3 is 2 cm, the wall thickness of the cannula 1 is 0.1 cm, and the outer diameter of the cannula 1 is one of 1.0 cm, 1.5 cm, 2.0 cm, and 3.0 cm, respectively suitable for 16-18G puncture needles, 4-5F sheaths, 6-7F sheaths, and 8-9F sheaths.

[0037] The inner core 2 is composed of multiple independent short columnar medical gelatin sponge units arranged sequentially. The inner core 2 is housed inside the front section of the cannula 1. The gelatin sponge strip is a compressible, absorbable, and biodegradable material that expands upon contact with liquid. After being pushed out of the puncture channel, it can completely seal the puncture channel through its own expansion. It usually degrades completely in about 2-3 weeks and has no impact on subsequent imaging examinations such as CT, MRI, and treatment. The surface of the medical gelatin sponge is coated with thrombin. The dry length of the medical gelatin sponge unit is 3-8 mm, preferably 5 mm, and its diameter matches the inner diameter of the cannula 1. The preset specifications are 0.8 cm, 1.3 cm, 1.8 cm, and 2.8 cm. The diameter of the medical gelatin sponge unit is the size after compression, and the diameter can increase to 3-4 times after self-expansion. A thin air gap or slight indentation can be provided between the medical gelatin sponge units to prevent them from sticking together. The cannula 1 can be pre-loaded with twenty medical gelatin sponge units, with the longest sealing length being 10 cm.

[0038] The length of the push rod 6 matches the length of the sleeve 1, and the diameter of the push rod 6 matches the inner diameter of the sleeve 1 and is inserted into the sleeve 1. The preset specifications are 0.8cm, 1.3cm, 1.8cm, and 2.8cm. The front end of the push rod 6 is rounded to prevent damage to the medical gelatin sponge unit. The rear end of the push rod 6 is provided with an enlarged handle 7 with a diameter of 3.2cm, which facilitates hand operation. The handle 7 abuts against the base 3 at the rear end of the sleeve 1 to prevent the push rod 6 from being completely inserted into the sleeve 1 during use and making it inconvenient to remove. The push rod 6 is made of medical polycarbonate or polypropylene material.

[0039] This solution also provides a sealing method for a multi-segment gelatin sponge-filled puncture channel sealing device, which includes the following steps: S1: After the percutaneous interventional procedure is completed, the needle sheath / cannula is left in the puncture channel; S2: Insert the cannula 1 pre-loaded with the inner core 2 into the puncture needle sheath / tube until the front end of the cannula 1 coincides with the front end of the puncture needle sheath / tube. S3: Insert the push rod 6 into the sleeve 1 along the wedge-shaped inlet 5 until the front end of the push rod 6 contacts the inner core 2; S4: Keep the push rod 6 stationary relative to the patient, and simultaneously withdraw the cannula 1 along with the puncture needle sheath / tube until the inner core 2 forms a continuous segmented packing from the deep end to the shallow end in the puncture channel; S5: Remove all instruments, and the indwelling multi-segment medical gelatin sponge unit expands and seals the puncture channel.

[0040] This solution pre-installs standardized multi-segment medical gelatin sponge units within the cannula 1, eliminating the need for preoperative measurement and cutting. This reduces the average operation time from the traditional 60-90 seconds to 10-30 seconds, increasing efficiency by approximately 70%-80%. Furthermore, the procedure can be performed by a single person using only one hand, simplifying the surgical process. Each medical gelatin sponge unit has a fixed length; the occlusion length can be precisely controlled by counting and pushing the units. The medical gelatin sponge units expand to 3-4 times their original volume within 30 seconds in bodily fluids, thus generating 25-35... The stable radial pressure of mmHg effectively stops bleeding; the segmented release of medical gelatin sponge units enables continuous, gapless packing from deep to superficial ends, effectively avoiding the problems of end cavities and superficial residues that are common with traditional whole-strip packing; the segmented medical gelatin sponge units increase the effective contact area by approximately 40%, enhancing tissue adhesion and coagulation reaction; thrombin can further accelerate clot formation, significantly shortening hemostasis time; at the same time, due to the segmented structure, even if some medical gelatin sponge units slightly shift due to tissue contraction, the overall sealing layer remains continuous and stable; in addition, the gelatin sponge can be completely degraded in vivo, without forming hard residues, avoiding foreign body reactions.

[0041] In summary, this approach enables safe, convenient, and efficient closure of the percutaneous puncture pathway after its establishment, effectively treating minor bleeding and reducing or eliminating the risk of secondary and major bleeding. This improves the safety of the procedure and reduces the incidence of adverse events.

[0042] Although the specific embodiments of the invention have been described in detail with reference to the accompanying drawings, this should not be construed as limiting the scope of protection of this patent; various modifications and variations that can be made by a person skilled in the art without inventive effort within the scope described in the claims are still within the scope of protection of this patent.

Claims

1. A multi-segmented gelatin sponge plugger puncture channel plugging device, characterized by, The application relates to a medical puncture needle sheath / peel, which comprises the following parts: a sleeve, which is an elongated tubular structure, the rear end of the sleeve is integrally formed with a cylindrical base, a wedge-shaped entrance is arranged in the base, and scale lines are arranged on the outer surface of the sleeve; an inner core, which is arranged in the front section of the sleeve and is composed of a plurality of independent short columnar medical gelatin sponge units arranged in sequence; and a push rod, which is inserted into the sleeve and has a diameter matched with the inner diameter of the sleeve, and the rear end of the push rod is provided with an enlarged hand holding part.

2. The multi-segmented gelatin sponge plugger puncture channel plugging device according to claim 1, characterized in that, The sleeve is made of transparent or semi-transparent medical polymer materials.

3. The multi-segmented gelatin sponge plugger puncture channel plugging device according to claim 1, wherein, The outer diameter of the sleeve is one of 1.0 cm, 1.5 cm, 2.0 cm and 3.0 cm.

4. The multi-segmented gelatin sponge plugger puncture channel plugging device according to claim 1, wherein, The dry length of the medical gelatin sponge unit is 3-8 mm, and the diameter of the medical gelatin sponge unit is matched with the inner diameter of the sleeve.

5. The multi-segmented gelatin sponge plugger puncture channel plugging device according to claim 1, wherein, The surface of the medical gelatin sponge is covered with thrombin.

6. The multi-segmented gelatin sponge plugger puncture channel plugging device according to claim 1, wherein, The length of the push rod is matched with the length of the sleeve, and the front end of the push rod is a round blunt head.

7. The multi-segmented gelatin sponge plug-in puncture channel plugging device according to claim 1, characterized in that, The push rod is made of medical polycarbonate or polypropylene materials.

8. A method of occluding using the multi-segmented gelatin sponge plug type puncture passage occluding device according to any one of claims 1 to 7, characterized in that, The application further discloses a medical puncture needle sheath / peel operation method, which comprises the following steps: S1: after a percutaneous puncture intervention operation is completed, a puncture needle sheath / peel tube is reserved in a puncture channel; S2: a sleeve preloaded with an inner core is inserted into the puncture needle sheath / peel tube until the front end of the sleeve is matched with the front end of the puncture needle sheath / peel tube; S3: a push rod is inserted into the sleeve along the wedge-shaped entrance until the front end of the push rod is contacted with the inner core; S4: the position of the push rod is kept relative to the patient, the sleeve is synchronously withdrawn backward together with the puncture needle sheath / peel tube until the inner core is continuously segmented and filled from a deep end to a shallow end in the puncture channel to reach a blocking length; S5: all instruments are withdrawn, the plurality of medical gelatin sponge units are expanded in the puncture channel, and the blocking is completed.

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