CN219089476U - A device for hemostasis after lumen surgery - Google Patents

Abstract

A postoperative hemostatic device for lumen surgery, which is composed as follows: a ventilation tube (1), an air bag (2) and an air inlet and outlet valve (3); wherein: the ventilation tube (1) is the main structure of the whole device, and it has a certain shape Stable tubular structural member; the airbag (2) is arranged at the proximal end of the inner end (1.1) of the ventilation tube (1); the in and out air valve (3) for inflation and deflation is connected to the airbag (2); its characteristics The reason is that an expansion and compression cotton layer (4) is also arranged outside the air bag (2). The hemostatic device after lumen surgery involved in the utility model is mainly used for the hemostasis operation during and after the lumen operation in the living body; its structural design is novel; it creatively proposes expansion and compression cotton layer 4, auxiliary drainage hole 1.1a, the semicircular notch at the inner end 1.1 and other auxiliary innovative structures have excellent technical effects in relevant tests, and they have relatively huge economic and social values that can be expected.

Description

A device for hemostasis after lumen surgery

technical field

The utility model relates to the structural part design and application technical field of a hemostatic device after a lumen operation, in particular to a hemostatic device after a lumen operation.

Background technique

In the prior art, postoperative hemorrhage is prone to occur during luminal surgery; for example: postoperative hemorrhage within 24 hours after anorectal surgery, internal hemorrhoid denucleation period bleeding, rectal anorectal inflammation erosive bleeding, lower rectal inflammatory bowel disease bleeding, Tumor bleeding in the lower rectum, etc., are clinical problems that plague surgeons and anorectal specialists; in order to achieve the purpose of hemostasis effectively, safely and conveniently, people are eager to obtain a better technical effect mainly for lumen surgery. The ultimate hemostatic device to meet the clinical needs of solving related problems.

Contents of the invention

The purpose of this utility model is to provide a hemostatic device after lumen surgery with excellent technical effects; especially, it has the ability to exhaust and discharge body fluid when necessary, and has a good hemostatic effect.

In order to effectively, safely and conveniently achieve the purpose of hemostasis, the utility model proposes a "double-chamber single-capsule" hemostatic device, and the specific contents are described as follows:

The utility model is a postoperative hemostatic device for lumen surgery, which is constituted as follows: ventilation tube 1, air bag 2 inlet and outlet valve 3; wherein: ventilation tube 1 is the main structure of the whole device, which is a tubular structure with certain shape stability parts; the airbag 2 is arranged at the inner end 1.1 of the ventilation tube 1 near the end; the inlet and outlet valve 3 for inflation and deflation is connected to the airbag 2; it is characterized in that: the outside of the airbag 2 is also provided with an expansion and compression cotton layer 4; The blood sucking expands to form a good sealing structure.

The hemostatic device after lumen surgery described in the utility model requires protection of the following content:

The hemostatic device after lumen surgery meets one of the following requirements:

One, the side that expands and compresses the cotton layer 4 away from the ventilation tube 1, that is, the outer surface, is provided with a silver-containing dressing layer or a calcium alginate dressing layer; the key of the silver-containing dressing is that it contains nano-silver particles, which have bactericidal ability; Silver-containing dressing layer, then the silver-containing dressing contains nano-silver particles, and the specific distribution density of nano-silver particles in the silver-containing dressing layer is 100-9500 particles per square centimeter; the particle size of nano-silver particles is 1-100nm; there are reports It is said that nano-silver has a stronger and more durable antibacterial effect than silver ions, and it is easy to induce the generation of active oxygen so as to play a bactericidal effect; the aforementioned nano-silver particle distribution density and particle size are preferred under the existing industrial background. The available parameters that work best;

The silver-containing dressing layer or the calcium alginate dressing layer arranged on the side away from the ventilation tube 1, i.e., the outer side of the expansion compression cotton layer 4, can be separated from the subject of the hemostatic device after the lumen operation when the hemostatic device after the lumen operation is removed, and can be used afterwards. It is decomposed and excreted from the body; if it is supplemented with a suitable substrate that facilitates the attachment of nano-silver particles, it can facilitate the precipitation of nano-silver ions after surgery and prevent adverse consequences after post-operative recovery;

Second, the expansion and compression cotton layer 4 is a water-absorbing and swelling layered structure with a wrinkled structure; the folds can ensure that the expansion and compression cotton layer 4 shrinks its volume before absorbing water; it can expand significantly after absorbing water; of course we should control its expansion In order to ensure the sealing effect of the lumen, the expansion should not be too small or too large. After expansion, the effect of assisting to block the lumen to form a sealing structure should also be considered. The tolerance of the lumen of the organism should be compared with the actual effect. Adjustment; therefore, there are the following two and three preferred content requirements; this is the best effect determined through a large number of experiments; naturally there are different specific preferred ranges corresponding to different lumens of different organisms;

Third, the thickness of the compression cotton layer 4 outside the airbag 2 is 0.2mm-15mm;

Fourth, the volume of the airbag 2 is 10-200ml; the length of the airbag 2 along the direction in which the ventilation tube 1 extends is 20-120mm;

Fifth, there are 1-50 auxiliary drainage holes 1.1a arranged on the wall of the inner end 1.1 of the ventilation pipe 1 near the end; the cross-sectional shape of the auxiliary drainage holes 1.1a is one of the following: circular, Ellipse, rhombus, regular polygon, curved-sided polygon, regular polygon or curved-sided polygon with smooth transition chamfers; these auxiliary drain holes 1.1a with different cross-sectional shapes can meet the needs of different use backgrounds respectively;

Sixth, the edge of the pipe wall at the inner end 1.1 port of the ventilation pipe 1 is provided with a curved edge structure, and the curved edge structure is one of the following: a circular arc, a part of an ellipse, or two or more sequentially connected Straight line segment; a certain combination of the above structures with smooth transition chamfers; mainly to increase the length of the edge curve of the tube wall; at the same time, it also takes into account: no damage to biological tissues (smooth transition chamfers can be set at the corners or Inclination and chamfering), at the same time, ease of processing and manufacturing should also be considered; this optimal requirement is deliberately set based on various considerations;

Seventh, the inner diameter of the ventilation tube 1 is 3-20mm, and the length of the ventilation tube 1 is 50mm-500mm; these parameter requirements are set corresponding to different lumens of different organisms; Different multiple preferred embodiments corresponding to specific preferred parameters;

Its eighth, the inlet and outlet air valve 3 communicates with the air bag 2 through the inlet and outlet trachea 3.1; the length of the inlet and outlet trachea 3.1 is 10-500mm;

3.1 Arrangement position of air inlet and outlet pipe meets one of the following requirements:

① The air inlet and outlet pipes 3.1 are all arranged outside the air pipe 1; it is easy to manufacture and compound, but the sealing effect may be poor due to the existence of external thin pipes; the effect is acceptable for some lumens; if the effect is not good, you can use it instead The form of ② or ③ below;

② The part of the inlet and outlet trachea 3.1 near the external port is arranged outside the ventilation tube 1; the part near the airbag 2 is arranged inside the outer surface of the inlet and outlet trachea 3.1, and the innermost end of the inlet and outlet trachea 3.1 is connected to the airbag through the opening on the wall of the inlet and outlet trachea 3.1 2;

③The part of the air inlet and outlet pipe 3.1 close to the external port is arranged outside the air pipe 1, and the middle section of the air inlet and outlet pipe 3.1 is arranged inside the outer surface of the air inlet and outlet pipe 3.1; the air inlet and outlet pipe 3.1 near the airbag 2 is partially arranged inside the outer surface of the air inlet and outlet pipe 3.1;

Its nine, the distance between the inner port of the inlet and outlet trachea 3.1 and the air bag 2 is 3-50mm.

The technical content that is further preferred to be protected is: the hemostatic device after lumen surgery meets one of the following requirements (this is a further preferred range to further ensure the technical effect; the effect is better):

One, in the expansion and compression cotton layer 4, the specific distribution density of nano-silver particles in the silver-containing dressing layer is 800-8500 grains per square centimeter; the particle size of nano-silver particles is 20-90nm;

Second, the thickness of the expansion and compression cotton layer 4 is 0.5mm-5mm;

Third, the volume of the airbag 2 is 20-100ml; the length of the airbag 2 along the extension direction of the ventilation tube 1 is 40-70mm; the wall thickness of the airbag 2 is 0.1-3mm; to ensure its own structural strength and pressure resistance;

Fourth, 2-18 auxiliary liquid drainage holes 1.1a are arranged on the pipe wall at the proximal end of the inner end 1.1 of the ventilation pipe 1;

Fifth, the edge of the pipe wall at the inner end 1.1 port of the ventilation pipe 1 is provided with a curved edge structure, and the curved edge structure is one of the following structures at 1-3 places: a circular arc, a part of an ellipse, 2 or 2 Straight line segments connected in sequence above; above structures with smooth transition chamfers;

Sixth, the inner diameter of the outer end of the vent pipe 1 is 6-12mm, and the length of the vent pipe 1 is 120mm-250mm;

Seventh, the length of the inlet and outlet trachea 3.1 is 80-170mm; the minimum outer diameter of the inlet and outlet trachea 3.1 is 0.5mm, and the maximum should not exceed 60% of the diameter of the ventilator 1 inner tube;

Eighth, the distance between the inlet and outlet trachea 3.1 internal port and the air bag 2 is 16-30mm.

A switchable valve 1.2 is also provided at the external outlet of the vent pipe 1, and the switchable valve 1.2 is specifically one of the following structures:

A plug through a sealing plug between the vent pipe 1;

Screw cap structure;

Tight-fit press-fit closure construction;

The outer outlet pipe wall of the ventilation tube 1 is connected with the switchable valve 1.2 through an intermediary connection structure to prevent the switchable valve 1.2 from being lost, and is convenient for adjustment and use during or after surgery.

The hemostatic device after lumen surgery meets one of the following requirements:

Firstly, a pressure sensor is provided on the air inlet and outlet pipe 3.1 to detect the gas pressure in the air bag, and if the pressure exceeds the standard or the pressure is released, the hemostatic effect will be invalidated;

Second, the expansion and compression cotton layer 4 specifically uses MG type calcium alginate in the form of spinning threads as the base material;

The material requirements are: use seaweed to extract sodium alginate after industrial treatment, (sodium alginate is a linear polysaccharide compound composed of monosaccharide β-D-mannuronic acid M and α-L-guluronic acid G) According to the difference of seaweed species and seaweed parts, the proportion of sodium alginate monosaccharide extracted is different; M type: low strength and high absorption; G type: high strength and low absorption; MG type: balanced strength and absorption. We choose MG type sodium alginate for our expansion compression cotton, and convert it into calcium alginate with higher hardness for application. The common molecular formula of sodium alginate is shown in Figure 3 and Figure 4;

Appearance of calcium alginate dressing: It is planned to be made into a spun thread; or it may be better to make a mesh structure;

Principle of action: When the calcium alginate dressing is applied to the surgical wound, the calcium ions in the dressing will exchange calcium-sodium ions with the sodium ions in the wound exudate. In this way, the strong calcium alginate is converted into water-soluble and flexible sodium alginate, which can absorb a large amount of blood and other body fluids, and form a hydrogel in the fibers inside the dressing, keeping the wound in a moist and ideal environment for healing , Accelerate wound self-healing. At the same time, calcium ions can promote the formation of local prothrombin activators, participate in the local blood coagulation process, and accelerate local blood coagulation.

Calcium alginate dressing also has great positive effects. Its characteristics are: safe and non-toxic; high hygroscopicity; hemostasis; gelation; promotion of wound healing;

Other related contents of the utility model are briefly introduced as follows:

1. The usage method of the hemostatic device after lumen surgery described in the utility model:

1. First test whether the air bag 2 is leaking, observe whether the expansion and compression cotton layer 4 can be deployed as scheduled, and put it into the lower part of the anal canal and rectum after the air is exhausted, marked by the red line;

2. Push in 20-100ml of gas or liquid from the outer gate of the auxiliary pipeline (inlet and outlet trachea 3.1), pressurize to stop bleeding, and play a fixed role at the same time;

3. Open the outer opening of the main pipeline (ventilation tube 1), and use the syringe to deliver intestinal cavity wound retention enema or hemostatic fluid through the pipeline. It can also drain and observe the bleeding in the intestinal cavity, and assist exhaustion to prevent abdominal distension and compressive dysuria in patients ;

4. The external part of the anus is fixed with adhesive tape;

2. Matters needing attention:

1. According to the amount of bleeding, drainage and other related conditions, determine the timing of hemostat withdrawal. You can also release air and water every 2-4 hours, and observe for half an hour after decompression. If bleeding occurs again, pressurize again to stop bleeding. Bleeding can try to withdraw the hemostat. The continuous pressurization time should not exceed 8 hours, and the total pressurization time should not exceed 12 hours. (The main purpose is to protect the rectal mucosa. If the rectal inflammation and erosion are severe, the time should be further shortened) The total time should not exceed 48 hours.

2. Pull out the hemostat, and observe the integrity of the air bag 2 and the opening of the main pipe. (The anus is a natural channel, and a small amount of residue can be excreted with feces, causing little damage; but if the wound is deep, the residue may be embedded in the wound surface, which will cause corresponding problems, especially pay attention to whether there is any damaged residue)

3. Problems to be solved:

1. The main pipeline (ventilation tube 1) should not be too hard to avoid contusion of the rectum, and should not be too soft to avoid occlusion when pressurized;

2. The inner opening and side wall opening of the main pipeline (ventilation pipe 1) should be rounded and unobstructed to prevent abrasion of the mucous membrane, blockage and air retention, and more importantly, to prevent fractures;

3. The sealing valve at the outer opening of the auxiliary pipeline (inlet and outlet pipe 3.1) should be elastically self-closing after being pierced by the syringe, similar to a trocar;

4. The material requirements for swelling and compressing the cotton layer 4 are blood-absorbing, hemostatic, anti-inflammatory, non-adherent to the wound surface and mucous membrane, strong integrity, and swelling ability. Currently, similar materials are known: calcium alginate dressing, silver ion dressing, etc.

4. Patent Highlights:

1. Expansion and compression of the cotton layer 4:

Material: Sodium alginate is extracted from seaweed industrially, (sodium alginate is a linear polysaccharide compound composed of monosaccharide β-D-mannuronic acid M and α-L-guluronic acid G) according to the type of seaweed, the part of seaweed Etc. difference, the proportion of extracted sodium alginate monosaccharide is different, M, type: low strength, high absorbability; G type: high strength, low absorbency; MG type: balanced strength and absorbability. We choose MG type sodium alginate for our expansion compression cotton, and convert it into calcium alginate with higher hardness for application.

2. The main drainage pipe (ventilation pipe 1) can adopt two kinds of specific technical solutions:

Made of hard rubber.

1. The arc-shaped opening at the head end drains intestinal fluid and blood, assists exhaust; infuses drugs and flushes the intestinal tract; 2. The arc-shaped opening on the side wall assists the function of the head-end opening and prevents the blockage of the head-end opening;

3 pairs of pipeline compression bags:

Soft rubber material.

1. The air bag 2 is similar to a balloon, which can be inflated and filled with water to expand, and the active force of pressurization to stop bleeding;

2 The air bag 2 surrounds the main pipeline (ventilation tube 1) to ensure that the force around the anal canal wall is consistent;

③The application of rubber material can ensure the effective tension when inflated and filled with water, and can also ensure the retracting force of the capsule before taking out the hemostat, which is convenient for non-invasive taking out. In addition, the capsule is ruptured due to excessive pressure or external force damage, so that it will not stab the anorectum and cause secondary damage.

The hemostatic device after lumen surgery involved in the utility model is mainly used for hemostasis during and after the lumen operation in the living body; its structural design is novel; it creatively proposes expansion and compression cotton layer 4, auxiliary drainage hole 1.1a, the semicircular notch at the inner end 1.1 and other auxiliary innovative structures have excellent technical effects in relevant tests, and they have relatively huge economic and social values that can be expected.

Description of drawings:

Fig. 1 is a schematic cross-sectional view of the structural principle of the hemostatic device after lumen surgery;

Figure 2 is a partial enlarged view of the lower part of Figure 1;

Fig. 3 is one of molecular formula of sodium alginate raw material;

Fig. 4 is the second molecular formula of sodium alginate raw material.

Detailed ways:

Describe the present invention in further detail by embodiment, but do not limit the scope of the present invention in any way:

The meanings of the reference signs are: ventilation pipe 1, inner end 1.1, auxiliary liquid discharge hole 1.1a; switchable valve 1.2, air bag 2, air inlet and outlet valve 3, air inlet and outlet pipe 3.1, air inlet and outlet valve 3.1a; expansion and compression cotton layer 4.

Example 1

A hemostatic device after luminal surgery, which is composed of the following: ventilation tube 1, air bag 2 inlet and outlet valve 3; wherein: ventilation tube 1 is the main structure of the whole device, which is a tubular structural member with certain shape stability; the air bag 2 Arranged at the inner end 1.1 of the ventilation tube 1 near the end; the inlet and outlet valve 3 for inflation and deflation is connected to the airbag 2; the outside of the airbag 2 is also provided with an inflatable compression cotton layer 4; it is convenient for blood sucking and expansion to form a good sealing structure .

The hemostatic device after lumen surgery meets one of the following requirements:

One, the expansion and compression cotton layer 4 is provided with a silver-containing dressing layer on the side away from the ventilation tube 1, that is, the outer surface; the key of the silver-containing dressing is that it contains nano-silver particles, which have bactericidal ability; if it is a silver-containing dressing layer, then The silver-containing dressing contains nano-silver particles, and the specific distribution density of the nano-silver particles in the silver-containing dressing layer is 800-8500 grains per square centimeter; the particle size of the nano-silver particles is 20-90nm; Silver ions have a stronger and more durable antibacterial effect, and it is easy to induce the generation of active oxygen to exert a bactericidal effect;

The silver-containing dressing layer arranged on the side away from the ventilator 1, that is, the outer side of the swelling compression cotton layer 4, can be separated from the subject of the hemostatic device after the lumen operation when the hemostatic device after the lumen operation is removed, and can be decomposed and excreted afterwards; if Supplemented with a suitable substrate that facilitates the attachment of nano-silver particles, it can facilitate the precipitation of nano-silver ions after surgery and prevent adverse consequences after post-operative recovery;

Second, the expansion and compression cotton layer 4 is a water-absorbing expansion layer structure with a wrinkled structure;

Its three, the expansion compression cotton layer 4 thickness on the outside of airbag 2 is 3mm;

Its four, the volume of air bag 2 is about 70ml; the length of air bag 2 along the direction of extension of vent tube 1 is 55mm; the wall thickness of air bag 2 is 0.8-2.5mm (uneven thickness); to ensure its own structural strength and pressure resistance;

Fifth, two auxiliary drainage holes 1.1a are arranged on the wall of the inner end 1.1 of the ventilation pipe 1 near the end; the cross-sectional shape of the auxiliary drainage holes 1.1a is one of the following: circular, oval, Rhombus, regular polygon, curved polygon, regular polygon or curved polygon with smooth transition chamfer;

Sixth, the edge of the pipe wall at the inner end 1.1 port of the ventilation pipe 1 is provided with a curved edge structure, and the curved edge structure is a part of a circular arc;

Seventh, the inner diameter of the ventilation pipe 1 is 6-12mm, and the length of the ventilation pipe 1 is 180mm;

Eighth, the inlet and outlet air valve 3 communicates with the air bag 2 through the inlet and outlet trachea 3.1; the length of the inlet and outlet trachea 3.1 is 130mm; the outer diameter of the inlet and outlet trachea 3.1 is 17% of the lumen diameter in the ventilation tube 1;

The air inlet and outlet pipes 3.1 are all arranged outside the air pipe 1;

Its nine, the distance between the inner port of the inlet and outlet trachea 3.1 and the air bag 2 is 23mm.

A switchable valve 1.2 is also provided at the external outlet of the ventilation pipe 1, and an inlet and outlet valve 3.1a is also arranged on the inlet and outlet pipe 3.1; the switchable valve 1.2 or/and the inlet and outlet valve 3.1a are specifically one of the following structures or a combination thereof : A plug that forms a tightly sealed structure with the pipeline; a screw cap structure; a tight-fitting press-fit cap structure; an elastically sealed valve; as shown in Figure 1 and Figure 2.

The outer outlet pipe wall of the ventilation tube 1 is connected with the switchable valve 1.2 through an intermediary connection structure to prevent the switchable valve 1.2 from being lost, and it is convenient for operation or postoperative adjustment and use;

The external outlet pipe wall of the air inlet and outlet pipe 3.1 and the air inlet and outlet air pipe valve 3.1a are connected as a whole through an intermediary connection structure to prevent the switchable valve 1.2 from being lost and facilitate adjustment and use during or after surgery.

The hemostatic device after lumen surgery meets the combination of the following requirements:

Firstly, a pressure sensor is provided on the air inlet and outlet pipe 3.1 to detect the gas pressure in the air bag, and if the pressure exceeds the standard or the pressure is released, the hemostatic effect will be invalidated;

Second, the expansion and compression cotton layer 4 is specifically based on MG-type calcium alginate in the form of spinning threads, and a silver-containing dressing layer is provided on the inner surface thereof.

Example 2

A hemostatic device after luminal surgery, which is composed of the following: ventilation tube 1, air bag 2 inlet and outlet valve 3; wherein: ventilation tube 1 is the main structure of the whole device, which is a tubular structural member with certain shape stability; the air bag 2 Arranged at the inner end 1.1 of the ventilation tube 1 near the end; the inlet and outlet valve 3 for inflation and deflation is connected to the airbag 2; the outside of the airbag 2 is also provided with an inflatable compression cotton layer 4; it is convenient for blood sucking and expansion to form a good sealing structure .

The hemostatic device after lumen surgery meets the combination of the following requirements:

One, the expansion and compression cotton layer 4 is provided with a calcium alginate dressing layer on the side away from the ventilation tube 1, that is, the outer side; When removing the hemostatic device after lumen surgery, it will be separated from the subject of the hemostatic device after lumen surgery, and then it can be decomposed and excreted from the body; if it is supplemented with a suitable base material that facilitates the adhesion of calcium alginate dressings, it can facilitate the removal of nano-silver ions after surgery. Precipitation to prevent adverse consequences after postoperative recovery;

Second, the expansion and compression cotton layer 4 is a water-absorbing expansion layer structure with a wrinkled structure;

Its three, the expansion compression cotton layer 4 thickness on the outside of airbag 2 is 0.65mm (before water absorption); After water absorption, it can become;

Fourth, the volume of the airbag 2 is 25ml; the length of the airbag 2 along the extension direction of the ventilation tube 1 is 42mm; the wall thickness of the airbag 2 is 0.15-1.3mm; to ensure its own structural strength and pressure resistance;

Fifth, an auxiliary drain hole 1.1a is arranged on the wall of the near end of the inner end 1.1 of the ventilation tube 1; the cross-sectional shape of the auxiliary drain hole 1.1a is one of the following: circular, oval , rhombus, regular polygon, curved polygon, regular polygon or curved polygon with smooth transition chamfer;

Sixth, the edge of the pipe wall at the inner end 1.1 port of the ventilation pipe 1 is provided with a curved edge structure, and the curved edge structure is one of the following: a circular arc, a part of an ellipse, or two or more sequentially connected Straight line segments; some combination of the above structures with rounded transition chamfers;

Seventh, the inner diameter of the ventilation pipe 1 is 6mm, and the length of the ventilation pipe 1 is 125mm;

Eighth, the inlet and outlet air valve 3 communicates with the air bag 2 through the inlet and outlet trachea 3.1; the length of the inlet and outlet trachea 3.1 is 85mm; the minimum outer diameter of the inlet and outlet trachea 3.1 is 0.5mm, and the maximum should not exceed 5% of the diameter of the ventilator 1 inner tube;

The part of the inlet and outlet trachea 3.1 near the external port is arranged outside the ventilation tube 1; the part near the airbag 2 is arranged inside the outer surface of the inlet and outlet trachea 3.1, and the innermost end of the inlet and outlet trachea 3.1 is connected to the airbag 2 through the opening on the wall of the inlet and outlet trachea 3.1 ;

Its nine, the distance between the inner port of the inlet and outlet trachea 3.1 and the air bag 2 is 16mm.

A switchable valve 1.2 is also provided at the external outlet of the ventilation pipe 1, and an inlet and outlet valve 3.1a is also arranged on the inlet and outlet pipe 3.1; the switchable valve 1.2 or/and the inlet and outlet valve 3.1a are specifically one of the following structures or a combination thereof : A plug that forms a tightly sealed structure with the pipeline; a screw cap structure; a tight-fitting press-fit cap structure; an elastically sealed valve;

The outer outlet pipe wall of the ventilation tube 1 is connected with the switchable valve 1.2 through an intermediary connection structure to prevent the switchable valve 1.2 from being lost, and it is convenient for operation or postoperative adjustment and use;

The external outlet pipe wall of the air inlet and outlet pipe 3.1 and the air inlet and outlet air pipe valve 3.1a are connected as a whole through an intermediary connection structure to prevent the switchable valve 1.2 from being lost and facilitate adjustment and use during or after surgery.

The hemostatic device after lumen surgery meets one or a combination of the following requirements:

Firstly, a pressure sensor is provided on the air inlet and outlet pipe 3.1 to detect the gas pressure in the air bag, and if the pressure exceeds the standard or the pressure is released, the hemostatic effect will be invalidated;

Second, the expansion and compression cotton layer 4 is specifically based on MG-type calcium alginate in the form of spinning threads, and a silver-containing dressing layer is provided on the inner surface thereof.

Example 3

A hemostatic device after luminal surgery, which is composed of the following: ventilation tube 1, air bag 2 inlet and outlet valve 3; wherein: ventilation tube 1 is the main structure of the whole device, which is a tubular structural member with certain shape stability; the air bag 2 Arranged at the inner end 1.1 of the ventilation tube 1 near the end; the inlet and outlet valve 3 for inflation and deflation is connected to the airbag 2; the outside of the airbag 2 is also provided with an inflatable compression cotton layer 4; it is convenient for blood sucking and expansion to form a good sealing structure .

The hemostatic device after lumen surgery meets the combination of the following requirements:

One, the side that expands and compresses the cotton layer 4 away from the ventilation tube 1, that is, the outer surface, is provided with a silver-containing dressing layer or a calcium alginate dressing layer; the key of the silver-containing dressing is that it contains nano-silver particles, which have bactericidal ability; Silver-containing dressing layer, then the silver-containing dressing contains nano-silver particles, and the specific distribution density of nano-silver particles in the silver-containing dressing layer is 4000-9500 particles per square centimeter; the particle size of nano-silver particles is 1-100nm; there are reports It is said that nano-silver has a stronger and more durable antibacterial effect than silver ions, and it is easy to induce the generation of active oxygen to play a bactericidal effect;

The silver-containing dressing layer arranged on the side away from the ventilator 1, that is, the outer side of the swelling compression cotton layer 4, can be separated from the subject of the hemostatic device after the lumen operation when the hemostatic device after the lumen operation is removed, and can be decomposed and excreted afterwards; if Supplemented with a suitable substrate that facilitates the attachment of nano-silver particles, it can facilitate the precipitation of nano-silver ions after surgery and prevent adverse consequences after post-operative recovery;

Second, the expansion and compression cotton layer 4 is a water-absorbing expansion layer structure with a fold structure; specifically, it is folds imitating a folding fan structure;

Its three, the expansion compression cotton layer 4 thickness on the outside of the airbag 2 is 4.8mm (the expansion compression cotton layer 4 thickness of the folded state before absorbing water);

Fourth, the volume of the airbag 2 is 96ml; the length of the airbag 2 along the extension direction of the ventilation tube 1 is 70mm; the wall thickness of the airbag 2 is 0.8-3mm; to ensure its own structural strength and pressure resistance;

Fifth, eight auxiliary drainage holes 1.1a are arranged on the wall of the inner end 1.1 of the ventilation pipe 1 near the end; the cross-sectional shape of the auxiliary drainage holes 1.1a is one of the following or some combination thereof: Circle, ellipse, rhombus, regular polygon, curved polygon, regular polygon or curved polygon with smooth transition chamfer;

Sixth, the edge of the pipe wall at the inner end 1.1 port of the ventilation pipe 1 is provided with a curved edge structure, and the curved edge structure is one of the following: a circular arc, a part of an ellipse, or two or more sequentially connected Straight line segments; some combination of the above structures with rounded transition chamfers;

Seventh, the inner diameter of the ventilation pipe 1 is 12mm, and the length of the ventilation pipe 1 is 240mm;

Its eighth, the inlet and outlet air valve 3 communicates with the air bag 2 through the inlet and outlet trachea 3.1; the length of the inlet and outlet trachea 3.1 is 165mm; the outer diameter of the inlet and outlet trachea 3.1 is 40% of the lumen diameter in the ventilation pipe 1;

The part of the air inlet and outlet pipe 3.1 close to the external port is arranged outside the ventilation pipe 1, and the middle section of the air inlet and outlet pipe 3.1 is arranged inside the outer surface of the air inlet and outlet pipe 3.1; the air inlet and outlet pipe 3.1 near the airbag 2 is partially arranged inside the outer surface of the air inlet and outlet pipe 3.1;

Its nine, the distance between the inner port of the inlet and outlet trachea 3.1 and the air bag 2 is 30mm.

A switchable valve 1.2 is also provided at the external outlet of the ventilation pipe 1, and an inlet and outlet valve 3.1a is also arranged on the inlet and outlet pipe 3.1; the switchable valve 1.2 or/and the inlet and outlet valve 3.1a are specifically one of the following structures or a combination thereof : A plug that forms a tightly sealed structure with the pipeline; a screw cap structure; a tight-fitting press-fit cap structure; an elastically sealed valve;

The outer outlet pipe wall of the ventilation tube 1 is connected with the switchable valve 1.2 through an intermediary connection structure to prevent the switchable valve 1.2 from being lost, and it is convenient for operation or postoperative adjustment and use;

The external outlet pipe wall of the air inlet and outlet pipe 3.1 and the air inlet and outlet air pipe valve 3.1a are connected as a whole through an intermediary connection structure to prevent the switchable valve 1.2 from being lost and facilitate adjustment and use during or after surgery.

The hemostatic device after lumen surgery meets one or a combination of the following requirements:

Firstly, a pressure sensor is provided on the air inlet and outlet pipe 3.1 to detect the gas pressure in the air bag, and if the pressure exceeds the standard or the pressure is released, the hemostatic effect will be invalidated;

Second, the expansion and compression cotton layer 4 is specifically based on MG-type calcium alginate in the form of spinning threads.

Example 4

A hemostatic device after luminal surgery, which is composed of the following: ventilation tube 1, air bag 2 inlet and outlet valve 3; wherein: ventilation tube 1 is the main structure of the whole device, which is a tubular structural member with certain shape stability; the air bag 2 Arranged at the inner end 1.1 of the ventilation tube 1 near the end; the inlet and outlet valve 3 for inflation and deflation is connected to the airbag 2; the outside of the airbag 2 is also provided with an inflatable compression cotton layer 4; it is convenient for blood sucking and expansion to form a good sealing structure .

The hemostatic device after lumen surgery meets one or a combination of the following requirements:

One, the expansion and compression cotton layer 4 is provided with a silver-containing dressing layer or a calcium alginate dressing layer on the side away from the ventilation tube 1; if it is a silver-containing dressing layer, the silver-containing dressing contains nano-silver particles, and The specific distribution density of particles in the silver-containing dressing layer is 100-9500 particles per square centimeter; the particle size of nano-silver particles is 1-100nm; the key to silver-containing dressings is that it contains nano-silver particles, which have bactericidal ability; there are reports It is said that nano-silver has a stronger and more durable antibacterial effect than silver ions, and it is easy to induce the generation of active oxygen to play a bactericidal effect;

The silver-containing dressing layer or the calcium alginate dressing layer arranged on the side away from the ventilation tube 1, i.e., the outer side of the expansion compression cotton layer 4, can be separated from the subject of the hemostatic device after the lumen operation when the hemostatic device after the lumen operation is removed, and can be used afterwards. It is decomposed and excreted from the body; if it is supplemented with a suitable substrate that facilitates the attachment of nano-silver particles, it can facilitate the precipitation of nano-silver ions after surgery and prevent adverse consequences after post-operative recovery;

Second, the expansion and compression cotton layer 4 is a water-absorbing expansion layer structure with a wrinkled structure;

Third, the thickness of the compression cotton layer 4 outside the airbag 2 is 0.2mm-15mm;

Fourth, the volume of the airbag 2 is 10-200ml; the length of the airbag 2 along the extension direction of the ventilation tube 1 is 20-120mm; the wall thickness of the airbag 2 is 0.1-3mm; to ensure its own structural strength and pressure resistance;

Fifth, 1-50 auxiliary drain holes 1.1a are arranged on the wall of the near end of the inner end 1.1 of the vent pipe 1; the cross-sectional shape of the auxiliary drain holes 1.1a is one of the following or a certain Combination: circle, ellipse, rhombus, regular polygon, curved polygon, regular polygon or curved polygon with smooth transition chamfer;

Sixth, the edge of the pipe wall at the inner end 1.1 port of the ventilation pipe 1 is provided with a curved edge structure, and the curved edge structure is one of the following: a circular arc, a part of an ellipse, or two or more sequentially connected Straight line segments; some combination of the above structures with rounded transition chamfers;

Seventh, the inner diameter of the ventilation pipe 1 is 3-20mm, and the length of the ventilation pipe 1 is 50mm-500mm;

Eighth, the air inlet and outlet valve 3 communicates with the air bag 2 through the air inlet and outlet pipe 3.1; the length of the air inlet and outlet pipe 3.1 is 10-500mm; the outer diameter of the air inlet and outlet pipe 3.1 is at least 0.5mm, and the maximum should not exceed 60% of the diameter of the vent pipe 1;

3.1 Arrangement position of air inlet and outlet pipe meets one of the following requirements:

① The air inlet and outlet pipes 3.1 are all arranged outside the air pipe 1;

② The part of the inlet and outlet trachea 3.1 near the external port is arranged outside the ventilation tube 1; the part near the airbag 2 is arranged inside the outer surface of the inlet and outlet trachea 3.1, and the innermost end of the inlet and outlet trachea 3.1 is connected to the airbag through the opening on the wall of the inlet and outlet trachea 3.1 2;

③The part of the air inlet and outlet pipe 3.1 close to the external port is arranged outside the air pipe 1, and the middle section of the air inlet and outlet pipe 3.1 is arranged inside the outer surface of the air inlet and outlet pipe 3.1; the air inlet and outlet pipe 3.1 near the airbag 2 is partially arranged inside the outer surface of the air inlet and outlet pipe 3.1;

Its nine, the distance between the inner port of the inlet and outlet trachea 3.1 and the air bag 2 is 3-50mm.

A switchable valve 1.2 is also provided at the external outlet of the ventilation pipe 1, and an inlet and outlet valve 3.1a is also arranged on the inlet and outlet pipe 3.1; the switchable valve 1.2 or/and the inlet and outlet valve 3.1a are specifically one of the following structures or a combination thereof : A plug that forms a tightly sealed structure with the pipeline; a screw cap structure; a tight-fitting press-fit cap structure; an elastically sealed valve;

The outer outlet pipe wall of the ventilation tube 1 is connected with the switchable valve 1.2 through an intermediary connection structure to prevent the switchable valve 1.2 from being lost, and it is convenient for operation or postoperative adjustment and use;

The external outlet pipe wall of the air inlet and outlet pipe 3.1 and the air inlet and outlet air pipe valve 3.1a are connected as a whole through an intermediary connection structure to prevent the switchable valve 1.2 from being lost and facilitate adjustment and use during or after surgery.

The hemostatic device after lumen surgery meets one or a combination of the following requirements:

Firstly, a pressure sensor is provided on the air inlet and outlet pipe 3.1 to detect the gas pressure in the air bag, and if the pressure exceeds the standard or the pressure is released, the hemostatic effect will be invalidated;

Second, the expansion and compression cotton layer 4 is specifically based on MG-type calcium alginate in the form of spinning threads, and a silver-containing dressing layer is provided on the inner surface thereof.

Example 5

Postoperative bleeding within 24 hours after anorectal surgery, bleeding during denucleation of internal hemorrhoids, erosive bleeding due to inflammation of the anorectal canal, inflammatory bowel disease bleeding in the lower rectum, tumor bleeding in the lower rectum, etc., are clinical problems that plague surgeons and anorectal specialists. Problem, in order to achieve the purpose of hemostasis effectively, safely and conveniently, a "dual-chamber single-capsule hemostatic device" is specially invented to meet the clinical needs of solving the above-mentioned related problems.

This embodiment is a postoperative hemostatic device for lumen surgery, which adopts two pipelines in parallel, the ventilation tube 1 and the inlet and outlet trachea 3.1. The diameter of the opening is about 6-8mm, each opening of the side wall is about 3-5mm, and the outer opening of the main pipe is 8-10mm, with its own closing valve (similar to the inflatable nozzle of the swimming ring). The auxiliary pipe is about 120mm long, the air bag is 50-60mm long, can be inflated or filled with 20-100ml of water, and the inflatable compression cotton is about 60-80mm long. The auxiliary pipe is equipped with a one-way airtight valve.

1. The method of using the hemostatic device after lumen surgery described in this embodiment:

1. First test whether the air bag 2 is leaking, observe whether the expansion and compression cotton layer 4 can be deployed as scheduled, and put it into the lower part of the anal canal and rectum after the air is exhausted, marked by the red line;

2. Push in 20-100ML gas or liquid from the outer gate of the air inlet and outlet pipe 3.1, pressurize to stop bleeding, and play a fixed role at the same time;

3. Open the main pipeline, that is, the outer opening of the ventilation tube 1, and use the syringe to give the intestinal cavity wound retention enema or hemostatic body delivery through the pipeline, and can also drain and observe the bleeding in the intestinal cavity, and assist exhaustion to prevent abdominal distension and oppressive dysuria in patients;

4. The external part of the anus is fixed with adhesive tape.

2. Matters needing attention:

1. According to the amount of bleeding, drainage and other related conditions, determine the timing of hemostat withdrawal. You can also release air and water every 2-4 hours, and observe for half an hour after decompression. If bleeding occurs again, pressurize again to stop bleeding. Bleeding can try to withdraw the hemostat. The continuous pressurization time should not exceed 8 hours, and the total pressurization time should not exceed 12 hours. (The main purpose is to protect the rectal mucosa. If the rectal inflammation and erosion are severe, the time should be further shortened) The total time should not exceed 48 hours.

2. Pull out the hemostat, and observe the integrity of the air bag 2 and the opening of the main pipe (ventilator 1). (The anus is a natural channel, and a small amount of residue can be excreted with feces, causing little damage; but if the wound is deep, the residue may be embedded in the wound surface, which will cause corresponding problems, especially pay attention to whether there is any damaged residue)

3. Problems to be solved:

1. The main pipeline (ventilation tube 1) should not be too hard to avoid contusion of the rectum, and should not be too soft to avoid occlusion when pressurized;

2. The inner opening and side wall opening of the main pipeline (ventilation pipe 1) should be rounded and unobstructed to prevent abrasion of the mucous membrane, blockage and air retention, and more importantly, to prevent fractures;

3. The sealing valve at the outer opening of the auxiliary pipeline (inlet and outlet pipe 3.1) should be elastically self-closing after being pierced by the syringe, similar to a trocar;

4. The material requirements for swelling and compressing the cotton layer 4 are blood-absorbing, hemostatic, anti-inflammatory, non-adherent to the wound surface and mucous membrane, strong integrity, and swelling ability. Currently, similar materials are known: calcium alginate dressing, silver ion dressing, etc.

4. Patent Highlights:

1. Expansion and compression of the cotton layer 4:

Material: Sodium alginate is extracted from seaweed industrially, (sodium alginate is a linear polysaccharide compound composed of monosaccharide β-D-mannuronic acid M and α-L-guluronic acid G) according to the type of seaweed, the part of seaweed Etc. difference, the proportion of extracted sodium alginate monosaccharide is different, M, type: low strength, high absorbability; G type: high strength, low absorbency; MG type: balanced strength and absorbability. We choose MG type sodium alginate for our expansion compression cotton, and convert it into calcium alginate with higher hardness for application.

Figure 3 and Figure 4 in the accompanying drawings are the molecular formulas of sodium alginate raw materials.

Appearance: Calcium alginate dressing made into spun thread

Principle of action: When the calcium alginate dressing is applied to the surgical wound, the calcium ions in the dressing will exchange calcium-sodium ions with the sodium ions in the wound exudate. In this way, the strong calcium alginate is converted into water-soluble and flexible sodium alginate, which can absorb a large amount of blood and other body fluids, and form a hydrogel in the fibers inside the dressing, keeping the wound in a moist and ideal environment for healing , Accelerate wound self-healing. At the same time, calcium ions can promote the formation of local prothrombin activators, participate in the local blood coagulation process, and accelerate local blood coagulation.

Calcium alginate dressing also has great positive effects. Its characteristics are: safe and non-toxic; high hygroscopicity; hemostasis; gelation; promotion of wound healing;

2. Drainage main pipe (ventilation pipe 1):

Made of hard rubber.

1. The arc-shaped opening at the head end drains intestinal fluid and blood, assists exhaust; infuses drugs and flushes the intestinal tract; 2. The arc-shaped opening on the side wall assists the function of the head-end opening and prevents the blockage of the head-end opening;

3 pairs of pipeline compression bags:

Soft rubber material.

1. The air bag 2 is similar to a balloon, which can be inflated and filled with water to expand, and the active force of pressurization to stop bleeding;

2 The air bag 2 surrounds the main pipeline (ventilation tube 1) to ensure that the force around the anal canal wall is consistent;

③The application of rubber material can ensure the effective tension when inflated and filled with water, and can also ensure the retracting force of the capsule before taking out the hemostat, which is convenient for non-invasive taking out. In addition, the capsule is ruptured due to excessive pressure or external force damage, so that it will not stab the anorectum and cause secondary damage.

Claims (4)

1. A post-operation hemostasis device for a lumen operation, which comprises the following components: the vent pipe (1) and the air bag (2) enter and exit the air valve (3); wherein: the vent pipe (1) is a main body structure of the whole device and is a tubular structural member with certain shape stability; the air bag (2) is arranged at the proximal end part of the inner end (1.1) of the vent pipe (1); an air inlet and outlet valve (3) for inflation and deflation is communicated with the air bag (2); the air bag (2) is also provided with an expansion compression cotton layer (4) outside;

the method is characterized in that: the post-surgical hemostasis device for a lumen surgery meets one of the following requirements:

firstly, a silver-containing dressing layer or a calcium alginate dressing layer is arranged on one side, namely the outer side surface, of the expansion compression cotton layer (4) far away from the vent pipe (1); if the silver dressing layer is a silver dressing layer, the silver dressing layer contains nano silver particles, and the specific distribution density of the nano silver particles in the silver dressing layer is 100-9500 particles per square centimeter; the grain diameter of the nano silver particles is 1-100nm;

secondly, the expansion compression cotton layer (4) is a water absorption expansion lamellar structure with a fold structure;

thirdly, the thickness of the expansion compression cotton layer (4) at the outer side of the air bag (2) is 0.2mm-15mm;

fourthly, the volume of the air bag (2) is 10-200ml; the length of the air bag (2) along the extending direction of the vent pipe (1) is 20-120mm;

fifthly, 1-50 auxiliary liquid discharge holes (1.1 a) are arranged on the pipe wall of the near end part of the inner end (1.1) of the ventilation pipe (1); the cross-sectional shape of the auxiliary liquid discharge hole (1.1 a) is one of the following: round, oval, diamond, regular polygon, curved polygon, regular polygon with rounded transition chamfer or curved polygon;

sixthly, the edge of the pipe wall at the port of the inner end (1.1) of the vent pipe (1) is provided with a curved edge structure, and the curved edge structure is one of the following structures: a part of an arc, an ellipse, and 2 or more straight line segments connected in sequence; the structure is provided with a smooth transition chamfer;

seventhly, the inner diameter of the vent pipe (1) is 3-20mm, and the length of the vent pipe (1) is 50-500 mm;

eighth, the air inlet and outlet valve (3) is communicated with the air bag (2) through the air inlet and outlet pipe (3.1); the length of the air inlet and outlet pipe (3.1) is 10-500mm;

the arrangement position of the air inlet and outlet pipe (3.1) meets one of the following requirements:

the air inlet and outlet pipes (3.1) are all arranged outside the vent pipe (1);

(2) the part of the air inlet and outlet pipe (3.1) close to the external port is arranged outside the vent pipe (1); the part close to the air bag (2) is arranged inside the outer surface of the air inlet and outlet pipe (3.1), and the innermost end of the air inlet and outlet pipe (3.1) is communicated with the air bag (2) through an opening on the pipe wall of the air inlet and outlet pipe (3.1);

(3) the part of the air inlet and outlet pipe (3.1) close to the external port is arranged outside the air pipe (1), and the middle section of the air inlet and outlet pipe (3.1) is arranged inside the outer surface of the air inlet and outlet pipe (3.1); the air inlet and outlet pipe (3.1) close to the air bag (2) is locally arranged inside the outer surface of the air inlet and outlet pipe (3.1);

and ninth, the distance between the inner port of the air inlet and outlet pipe (3.1) and the air bag (2) is 3-50mm.

2. A post-surgical hemostasis apparatus in accordance with claim 1 wherein:

the post-surgical hemostasis device for a lumen surgery meets one of the following requirements:

firstly, in the expansion compression cotton layer (4), the specific distribution density of nano silver particles in the silver-containing dressing layer is 800-8500 particles per square centimeter; the grain diameter of the nano silver particles is 20-90nm;

secondly, the thickness of the expansion compression cotton layer (4) is 0.5mm-5mm;

thirdly, the volume of the air bag (2) is 20-100ml; the length of the air bag (2) along the extending direction of the vent pipe (1) is 40-70mm; the wall thickness of the air bag (2) is 0.1-3mm; to ensure the structural strength and pressure resistance of the steel plate;

fourthly, 2-18 auxiliary liquid discharge holes (1.1 a) are arranged on the pipe wall of the near end part of the inner end (1.1) of the ventilation pipe (1);

fifthly, the edge of the pipe wall at the port of the inner end (1.1) of the vent pipe (1) is provided with a curved edge structure, and the curved edge structure is one of the following structures at 1-3 positions: a part of an arc, an ellipse, and 2 or more straight line segments connected in sequence; some combination of the above structures with rounded transition chamfers;

sixthly, the inner diameter of the outer end part of the vent pipe (1) is 6-12mm, and the length of the vent pipe (1) is 120-250 mm;

seventhly, the length of the air inlet and outlet pipe (3.1) is 80-170mm; the minimum external diameter of the air inlet and outlet pipe (3.1) is 0.5mm, and the maximum external diameter is not more than 60% of the internal diameter of the air inlet pipe (1);

eighth, the distance between the inner port of the air inlet and outlet pipe (3.1) and the air bag (2) is 16-30mm.

3. A post-surgical hemostasis device in accordance with claim 1 or 2 wherein: the external outlet of the vent pipe (1) is also provided with a switchable valve (1.2), and the air inlet and outlet pipe (3.1) is also provided with an air inlet and outlet pipe valve (3.1 a); the switchable valve (1.2) and/or the air inlet and outlet pipe valve (3.1 a) are/is specifically one of the following structures: a plug which forms a tight sealing structure with the pipeline; a spiral capping structure; a press fit closure structure in close fit; a resiliently sealable valve;

the outer outlet pipe wall of the vent pipe (1) is connected with the switchable valve (1.2) into a whole through an intermediate connecting structure;

the outer outlet pipe wall of the air inlet and outlet pipe (3.1) is connected with the air inlet and outlet pipe valve (3.1 a) into a whole through an intermediate connecting structure.

4. A post-surgical hemostasis device in accordance with claim 3 wherein: the post-surgical hemostasis device for a lumen surgery meets one of the following requirements:

firstly, a pressure sensor is arranged on an air inlet and outlet pipe (3.1);

secondly, the expansion compression cotton layer (4) specifically takes MG-shaped calcium alginate in a spinning line shape as a base material, and a silver-containing dressing layer is arranged on the inner side surface of the expansion compression cotton layer.

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