CN116269592A - Adjustable intra-abdominal pressure hemostasis device - Google Patents

Abstract

The invention provides a regulatable intra-abdominal pressure hemostasis device, an external hemostasis layer is in a bag shape, and is wrapped outside an internal compression layer, the internal compression layer comprises an air bag part and an extension tube, the shape of the air bag part is changed through pressure change, and two ends of the extension tube are respectively connected with outlets of the air bag part and an air pump; the external hemostatic layer is pressed against the intraperitoneal wound surface, and the friction force between the external hemostatic layer and the intraperitoneal wound surface is larger than the friction force between the external hemostatic layer and the internal compression layer. The device is placed in the abdomen and is pressed on the wound surface in the abdomen to act, and the double-layer structure that the inner pressing layer is nested in the outer hemostatic layer improves the anti-adhesion function; the outer side surface of the outer hemostatic layer is slightly rough, which is beneficial to improving the contact with and close fit with the wound surface in the abdominal cavity; the inner side surface of the outer hemostatic layer is smooth and can be easily separated from the outer surface of the inner compressing layer, so that the detachable structure of the inner compressing layer and the outer hemostatic layer is realized.

Description

Adjustable intra-abdominal pressure hemostasis device

Technical Field

The invention relates to the technical field of medical equipment, in particular to an adjustable intra-abdominal pressure hemostasis device.

Background

In clinical diagnosis and treatment activities, in the abdominal operation process of a patient, for example, serious injury of the liver, complex liver cancer excision, portal hypertension operation, liver transplantation operation and other complex abdominal operation processes, serious consequences can be caused by the fact that the patient can bleed out, which is still difficult to control by an operation technology, due to the fact that the patient cannot stop bleeding, and the solution is a clinical problem. In the case that complete hemostasis cannot be performed by surgical procedures, medicines, blood products and the like, in order to preserve life, a decision must be made quickly, and bleeding is controlled as soon as possible by corresponding measures, which is an intelligent choice. The bleeding part of the abdominal cavity is filled with gauze clinically to achieve the effect of bleeding control. The reason is that: the local pressure can be increased by pressing through the gauze packing, so that the bleeding of the blood vessel outwards is reduced; the gauze contacts the bleeding part, so that the activation of a coagulation system can be promoted, and the hemostatic effect is enhanced; after the gauze is pressurized and stuffed, the bleeding is reduced, so that the hemostatic effect is further enhanced for improving the blood pressure, the consumption of blood coagulation substances and the general condition of a patient. The implementation time of the tamponade hemostasis varies from 3 to 10 days, and according to the hemostasis effect, abdominal infection and systemic recovery, the tamponade gauze must be removed by selecting a machine and further treated, and the method for providing the opportunity for further surgical treatment by reducing the damage of single surgical operation and winning the body recovery opportunity for patients is also called as a damage control surgical technique, and the abdominal gauze tamponade is an effective bleeding control method of the technique for uncontrollable bleeding caused by multiple injuries, major operations and the like. However, the gauze packing hemostasis method has the following technical drawbacks, which result in limited application of the method, including: 1) The shape of the abdominal cavity to be filled is different, the number and the shape of the gauze to be filled are different, so that filling difficulty is increased, the deformation capability of the gauze is limited, the water (blood) is worse after being wet, the adjustment capability is limited when the filling effect is poor, and meanwhile, if the gauze is checked incorrectly, medical errors such as the left gauze of the abdominal cavity can be caused, and unnecessary damage is caused to a human body; 2) For the human body, the gauze is a foreign body, and long-time retention in the abdominal cavity can cause complications such as infection, ascites and the like; 3) The gauze can be shaped at will when in use, so as to fit the shape of the compression part, but the deformation function is reduced once the blood and the body fluid are adsorbed, so that the compression effect is reduced, and the taking out is inconvenient; 4) The gauze can promote blood coagulation, but blood clots can also form adhesion between the gauze and tissues, when the hemostatic effect is achieved, the wound surface which is scabbed possibly to be torn open and bleeding again because of adhesion is possibly caused when the gauze is pulled out, and even the problem of re-operation is solved. To solve the above problems, there are some improvement measures clinically, such as selecting to use a single piece of strip gauze for filling, so as to avoid the risk of counting errors, but the ability to adjust the shape and volume is reduced; or a water sac or an air sac is used for replacing gauze, such as the disclosed wound auxiliary compression hemostasis device for hepatectomy (application number: 2019209036581), but the single air sac cannot adapt to the abdominal cavity environment with an irregular shape due to limited deformability, so that the compression surface is possibly empty; in the multi-balloon hemostatic structure disclosed as the 'balloon hemostat' (application number: 2015208603914), the water (balloon) directly contacts the wound surface, and the problem that the wound surface thrombus is torn off to cause secondary bleeding during withdrawal exists. Therefore, although the abdominal cavity compression is a method for truly and effectively controlling the bleeding uncontrollably in the abdominal cavity, the method cannot be better popularized due to the defects of the compression equipment, and the beneficial people are limited.

Therefore, how to design an intra-abdominal pressure hemostasis device with a shape and adjustable pressure, how to repeatedly adjust pressure and volume and have anti-adhesion effect, and how to perform an intra-abdominal pressure packing device convenient and safe to remove becomes a problem to be solved.

Disclosure of Invention

The invention provides an adjustable intra-abdominal pressure hemostasis device aiming at the problems in the prior art so as to solve at least one technical problem.

The technical scheme of the invention is as follows: the adjustable intra-abdominal pressure hemostasis device is characterized in that the external hemostasis layer is in a bag shape, is wrapped outside the internal compression layer, the internal compression layer comprises an air bag part and an extension tube, the shape of the air bag part is changed through pressure change, and two ends of the extension tube are respectively connected with the air bag part and the outlet of the air pump; the external hemostatic layer is pressed against the intraperitoneal wound surface, and the friction force between the external hemostatic layer and the intraperitoneal wound surface is larger than the friction force between the external hemostatic layer and the internal compression layer; the external hemostatic layer is made of hemostatic and antibacterial materials which can be absorbed by human body and have certain ductility, and can be placed in the abdomen for self absorption and decomposition by the body.

The device is placed in the abdomen and is pressed on the wound surface in the abdomen to act, and the double-layer structure that the inner pressing layer is nested in the outer hemostatic layer improves the anti-adhesion function; the outer side surface of the outer hemostatic layer is slightly rough, which is beneficial to improving the contact with and close fit with the wound surface in the abdominal cavity; the inner side surface of the outer hemostatic layer is smooth and can be easily separated from the outer surface of the inner compressing layer, so that a detachable structure of the inner compressing layer and the outer hemostatic layer is realized; when the inflatable air bag is inflated, the air bag part can be formed into different shapes according to the external space to expand outwards, and the shape and the pressure can be regulated and controlled, so that the target space is filled as much as possible.

Preferably, the air bag part is formed by communicating a plurality of small air bags, any adjacent small air bags are connected through an inner-layer air bag channel, and the air bag part is formed by connecting a plurality of small air bags in parallel, connecting the small air bags in series or mixing the small air bags in parallel and forming a grape-like structure, so that the small air bags inflated by each air bag part and the shape change after inflation are facilitated; the small air bags of the air bag part can be mutually communicated or can be communicated in a string form in a row; each small air bag can be designed in different shapes such as a round shape, an oval shape, a hexagon shape and the like, so that the mutual influence is reduced in the outward expansion process of the small air bags, and the expansion efficiency is improved; the external hemostatic layer and the internal compression layer are degradable film bags, and the film bags of the internal compression layer can have elasticity or not.

When the inflatable abdominal cavity is inflated, each small air bag forming the air bag part can be expanded outwards in different shapes according to the external space through the inner air bag channels, so that the target space is filled as much as possible, the internal compression layer is inflated by the air pump and gradually swells and expands the external hemostatic layer, the external hemostatic layer keeps adhering to wound tissues after swelling, can compress tissues such as wounds and blood vessels in the abdominal cavity, can perform intra-abdominal pressure hemostasis, can repeatedly adjust pressure and volume, has anti-adhesion effect, and can be conveniently and safely removed.

Drawings

Fig. 1 is a schematic view of a compression wound in use of the present invention.

Fig. 2 is a schematic illustration of a compression wound according to a second embodiment of the present invention.

FIG. 3 is a schematic illustration of the interconnection of inner cells according to a second embodiment of the present invention.

Fig. 4 is a cross-sectional view of a grape-shaped small balloon according to a second embodiment of the present invention.

Fig. 5 is a schematic view of the internal compression layer compression structure of the present invention.

Fig. 6 is an expanded view of an external hemostatic layer of the present invention.

Fig. 7 is a schematic view of the external hemostatic layer compression structure of the present invention.

Fig. 8 is an assembled view of an outer hemostatic layer and an inner compression layer of the present invention.

Fig. 9 is a schematic view of the structure of the first guide piece of the present invention.

Fig. 10 is a schematic view of the structure of the second guide piece of the present invention.

FIG. 11 is a schematic view of the handle structure of the present invention.

Fig. 12 is a schematic view of the guide mounting structure of the present invention.

Fig. 13 is a schematic view showing the mounting structure of the guide and the compression hemostasis device of the present invention.

In the figure: 1. an abdominal wall; 2. a wound surface in the abdominal cavity; 3. an outer hemostatic layer; 4. an inner compression layer; 5. an extension tube; 6. a valve; 7. an air pump; 8. a one-way gas check luer valve; 9. a pressure measurement control unit; 10. an air bag section; 11. an inner layer balloon channel; 12. an inner layer clamping groove; 13. an operation unit; 14. an outer layer clasp; 15. a sliding port; 16. a protruding portion; 17. a groove; 18. an introducer handle; 19. guide piece draw-in groove.

Detailed Description

The invention is further described below with reference to the accompanying drawings.

Referring to fig. 1-13, the structures, proportions, sizes, etc. shown in the drawings attached hereto are shown only in order to provide a person skilled in the art with the benefit of the present disclosure, and are not intended to limit the scope of the invention which is defined by the claims, so that any structural modifications, changes in proportions, or adjustments of sizes, which do not affect the efficacy or the objects achieved by the present invention, are deemed to fall within the ambit of the technical disclosure. Also, the terms such as "upper," "lower," "left," "right," "middle," and "a" and the like recited in the present specification are merely for descriptive purposes and are not intended to limit the scope of the invention, but are intended to provide relative positional changes or modifications without materially altering the technical context in which the invention may be practiced.

In the first embodiment, referring to fig. 1 and 2, the outer hemostatic layer 3 is in a bag shape and is wrapped outside the inner compressing layer 4, the inner compressing layer 4 includes an air bag portion 10 and an extension tube 5, the shape of which is changed by pressure change, and two ends of the extension tube 5 are respectively connected with the air bag portion 10 and the outlet of the air pump 7; the external hemostatic layer 3 presses the intraperitoneal wound surface 2, and the friction force between the external hemostatic layer 3 and the intraperitoneal wound surface 2 is larger than the friction force between the external hemostatic layer 3 and the internal pressing layer 4; the external hemostatic layer 3 is made of hemostatic and antibacterial materials which can be absorbed by human body and have certain ductility, and can be placed in the abdomen for self absorption and decomposition by the body. The device is placed in the abdomen and is pressed on the wound surface in the abdomen to act, and the double-layer structure that the inner pressing layer is nested in the outer hemostatic layer improves the anti-adhesion function; the outer side surface of the outer hemostatic layer is slightly rough, which is beneficial to improving the contact with and close fit with the wound surface in the abdominal cavity; the inner side surface of the outer hemostatic layer is smooth and can be easily separated from the outer surface of the inner compressing layer, so that a detachable structure of the inner compressing layer and the outer hemostatic layer is realized; when the inflatable air bag is inflated, the air bag part can be formed into different shapes according to the external space to expand outwards, and the shape and the pressure can be regulated and controlled, so that the target space is filled as much as possible.

Based on the second embodiment and referring to fig. 3 and fig. 4, the air bag portion 10 is formed by communicating a plurality of small air bags, any adjacent small air bags are connected through an inner air bag channel 11, and the air bag portion 10 is formed by mixing a plurality of small air bags in parallel, in series or in parallel to form a grape-like structure, so that the inflated small air bags and the shape change after inflation are facilitated; the plurality of small air bags of the air bag part 10 can be mutually communicated or can be communicated in a series and a row; each small air bag can be designed in different shapes such as a round shape, an oval shape, a hexagon shape and the like, so that the mutual influence is reduced in the outward expansion process of the small air bags, and the expansion efficiency is improved; the outer hemostatic layer 3 and the inner compressing layer 4 are degradable film bags, and the film bags of the inner compressing layer 4 can have elasticity or not. When the inflatable abdominal cavity is inflated, each small air bag forming the air bag part can be expanded outwards in different shapes according to the external space through the inner air bag channels, so that the target space is filled as much as possible, the internal compression layer is inflated by the air pump and gradually swells and expands the external hemostatic layer, the external hemostatic layer keeps adhering to wound tissues after swelling, can compress tissues such as wounds and blood vessels in the abdominal cavity, can perform intra-abdominal pressure hemostasis, can repeatedly adjust pressure and volume, has anti-adhesion effect, and can be conveniently and safely removed.

In the third embodiment, on the basis of the second embodiment, a valve 6 is disposed at the outlet of the air pump 7, the inner compression layer 4 further includes a pressure measurement control portion 9, and the pressure measurement control portion 9 is located between the extension tube 5 and the valve 6; a common gas switching valve or a one-way gas check luer valve 8 is also arranged between the valve 6 and the extension tube 5. The invention adopts the pressure measurement control part to connect with the air bag part through the extension pipe, and the air bag part is inflated, deflated and kept with air pressure through the valve, the whole pressure level of the air bag part can be measured, thus the pressure formed by the air bag part of the device is monitored, and a recording structure for recording and displaying the measured pressure value and the maintenance time is arranged at the same time; the extension tube is of a hollow tubular structure and is used for connecting the air sac part and the pressure measurement control part, so that the device can be operated at a position far away from the abdominal cavity, the extension tube can be permanently connected with the air sac part and the pressure measurement control part, and a disconnection self-sealing joint can be arranged, so that the three parts can be disconnected as required without affecting the use; the one-way gas check luer valve can keep the pressure stable; the one-way check gas luer valve can be opened when the valve is inflated, the valve automatically rebounds to be closed when the valve is disassembled, and the detachable connection part of the air bag and the pipeline can be detachably connected in a sealing mode such as thread sealing, elastic interference fit and the like.

In the fourth embodiment, referring to fig. 5, an operation portion 13 is disposed at the opening of the outer hemostatic layer 3, and the operation portion 13 is made of a degradable material. The invention adopts the operation part, which is favorable for operation and holding.

Based on the fifth embodiment, referring to fig. 6, 7 and 8, an outer layer clamping ring 14 is provided on the outer hemostatic layer 3, an inner layer clamping groove 12 is provided on the inner compressing layer 4, the outer layer clamping ring 14 is matched with the inner layer clamping groove 12, and the outer layer clamping ring 14 and the inner layer clamping groove 12 are located outside the air sac junction of the air sac part 10; the operation part 13 is positioned far away from the matching position of the outer clamping ring 14 and the inner clamping groove 12; the outer clasp 14 is formed of a degradable material. The invention adopts the outer layer clamping ring to be fixed with the inner layer clamping groove, which is beneficial to the fixation of the inner layer and the outer layer; the operation part can facilitate the separation operation of forming an acting point when the external hemostatic layer and the internal compression layer are separated; the operation part is clamped by hands or surgical instruments, so that the separation operation is more convenient.

On the basis of the sixth embodiment, referring to fig. 9, 10, 11 and 13, the compression hemostasis device is not only suitable for open surgery, but also suitable for laparoscopic surgery, because the external hemostasis layer 3 and the internal compression layer 4 of the compression hemostasis device are made of flexible film materials, when passing through the poking hole of the laparoscopic puncture outfit, the blocking can occur with the gas check valve in the puncture outfit, so that the compression hemostasis device is difficult to enter the abdominal cavity, and is more convenient to apply to laparoscopic surgery, the compression hemostasis device is also connected with a guide, the compression hemostasis device can conveniently pass through the poking hole of the laparoscopic puncture outfit through the guide, the guide comprises a circular arc-shaped first guide piece and a second guide piece, a sliding opening 15 is arranged on the first guide piece along the circumference, the second guide piece is composed of an arc-shaped plate and a handle, the arc-shaped plate is positioned on the inner ring of the first guide piece, a protruding part 16 is arranged on the arc-shaped plate, a groove 17 corresponding to the protruding part 16 is arranged on the handle, the protruding part 16 and the handle is combined, and a guide piece clamping groove 19 is formed on the second guide piece, and the guide piece 19 is arranged corresponding to the sliding opening 15. The invention adopts the arc-shaped plate and the handle to combine and form the guide piece clamping groove corresponding to the sliding opening of the first guide piece on the second guide piece, the first guide piece and the second guide piece can be closed or opened along the circumference line through the matching of the guide piece clamping groove and the sliding opening to form a cylindrical cavity, the compression hemostasis device is made into a rod shape when in an initial compression state, the guide is inserted into a poking hole of a laparoscope puncture outfit, the rod-shaped compression body can enter the abdominal cavity through the cylindrical cavity formed by the guide, then the guide is withdrawn, the handles of the first guide piece and the second guide piece are rotated to form a semicircular cavity, the airway pipeline can be separated from the gap of the guide, then an air pump is operated to perform compression hemostasis in the laparoscope operation, after the hemostasis task is completed, the guide is inserted into the poking hole of the laparoscope puncture outfit, the inner layer is withdrawn from the cavity of the guide, and the outer layer is made of an absorbable and degradable material and can be placed in the abdominal cavity to be automatically absorbed and decomposed by the body.

In the seventh embodiment, on the basis of the sixth embodiment, the arc plate and the handle of the second guide sheet are combined by any one of interference fit nesting, bonding or welding.

In the eighth embodiment, referring to fig. 12 and 13, the outer ring of the first guide piece is provided with a guide handle 18, the sliding opening 15 is arranged along the outer arc surface of the first guide piece, and the guide piece clamping groove 19 can slide along the sliding opening 15. The invention can make the first guide piece and the second guide piece close or open along the circumference line by the matching of the guide piece clamping groove and the sliding opening.

In the ninth embodiment, based on the first embodiment, the outer hemostatic layer 3 is made of an absorbable and degradable material, and can be placed in the abdomen to be absorbed and dissolved by the body; a biocompatible lubricant can be added into the inner layer of the outer hemostatic layer 3, so that the friction force between the inner compression layer and the outer hemostatic layer is further reduced; the inner compression layer 4 is made of flexible materials such as rubber, latex, silica gel, plastic or the like, and the air passage pipeline is made of materials such as rubber, latex, silica gel, plastic or metal.

In the tenth embodiment, the airbag section 10 may have an elliptical structure as a whole, and may be purposely extended in a specific direction by adjusting the longitudinal direction.

In the eleventh embodiment, in addition to the second embodiment, the air bag portion 10 may have a circular structure as a whole, and may be conveniently placed.

In specific implementation, when the device is used, the device is pre-placed at a position needing to be compressed, so that the external hemostatic layer 3 is properly attached to the intraperitoneal wound surface 2, the air bag part 10 is inflated gradually through the pressure measurement control part 9 of the internal compressing layer 4, the device position is fixed at the position needing to be compressed, and the compression hemostatic effect is achieved through the pressure increase. If the position is not proper, the air bag part 10 can be inflated and deflated to adjust the position until the effect is satisfactory; the pressure control measuring part 9 can monitor the inner layer pressure state at any time, and the pressure measurement controlling part 9 can record and display the inflation and deflation time and the pressure value through an electronic device; the pressure measurement control part 9 can control the inflation and deflation and maintain the pressure state through a three-way structure; if the wound surface is large, the single device can not effectively stop bleeding under pressure, and the hemostatic area can be increased by adding the device. When the hemostasis is effective, the pressure of the internal compression layer 4 is gradually reduced according to clinical requirements, so that the volume of the internal compression layer is reduced, drainage conditions are observed, the effect after the device is removed is evaluated, and if the bleeding is increased, the internal compression layer 4 can be repeatedly inflated and pressurized to adjust the pressure of the device, so that the hemostasis by compression effect is increased; when the hemostatic device is used, the pressure of the inner compression layer 4 is ensured to be completely released, the volume is reduced to the minimum, the hemostatic effect reaches the expected value, the inner compression layer 4 can be easily pulled out, the outer hemostatic layer 3 is left at the original position, and the hemostatic layer is degraded and absorbed, so that the situation of secondary bleeding caused by tearing off a wound surface is avoided. The device can be made into different models according to the expansion volume difference, and is favorable for selection according to actual conditions.

The foregoing is merely a preferred embodiment of the present invention and it should be noted that modifications and adaptations to those skilled in the art may be made without departing from the principles of the present invention, which are intended to be comprehended within the scope of the present invention.

Claims (10)

1. An adjustable intra-abdominal pressure hemostasis device comprising an outer hemostasis layer (3) located within an abdominal wall (1), characterized by: the external hemostatic layer (3) is in a bag shape, is wrapped outside the internal compressing layer (4), the internal compressing layer (4) comprises an air bag part (10) and an extension tube (5), the shape of the air bag part is changed through pressure change, and two ends of the extension tube (5) are respectively connected with the air bag part (10) and the outlet of the air pump (7); the external hemostatic layer (3) presses the intraperitoneal wound surface (2), and the friction force between the external hemostatic layer (3) and the intraperitoneal wound surface (2) is greater than the friction force between the external hemostatic layer (3) and the internal pressing layer (4).

2. A regulatable intra-abdominal pressure hemostatic device according to claim 1, wherein: the air bag part (10) is formed by communicating a plurality of small air bags.

3. A regulatable intra-abdominal pressure hemostatic device according to claim 2, wherein: the outlet of the air pump (7) is provided with a valve (6), the internal compression layer (4) further comprises a pressure measurement control part (9), the pressure measurement control part (9) is positioned between the extension pipe (5) and the valve (6), and a one-way gas check luer valve (8) is further arranged between the valve (6) and the extension pipe (5).

4. A regulatable intra-abdominal pressure hemostatic device according to claim 3, wherein: an operation part (13) is arranged at the opening of the external hemostatic layer (3).

5. A regulatable intra-abdominal pressure hemostatic device according to claim 4, wherein: the external hemostatic layer (3) is provided with an outer layer clamping ring (14), the internal compression layer (4) is provided with an inner layer clamping groove (12), the outer layer clamping ring (14) is matched with the inner layer clamping groove (12), and the operating part (13) is located at a position away from the matching position of the outer layer clamping ring (14) and the inner layer clamping groove (12).

6. A regulatable intra-abdominal pressure hemostatic device according to claim 5, wherein: the hemostasis by compression device is still connected with the director, and the director includes convex first guide piece and second guide piece, is provided with sliding port (15) along the circumference on the first guide piece, and the second guide piece comprises arc and handle, and the arc is located first guide piece inner circle, is equipped with bulge (16) on the arc, is equipped with recess (17) with bulge (16) nest correspondence on the handle, forms guide piece draw-in groove (19) on the second guide piece after bulge (16) and handle make up, and guide piece draw-in groove (19) correspond with sliding port (15) of first guide piece and arrange.

7. A regulatable intra-abdominal pressure hemostatic device according to claim 6, wherein: the arc-shaped plate and the handle of the second guide piece are combined in any one mode of interference fit nesting, bonding or welding.

8. A regulatable intra-abdominal pressure hemostatic device according to claim 6, wherein: the outer ring of the first guide piece is provided with a guide handle (18), the sliding opening (15) is arranged along the outer arc surface of the first guide piece, and the guide piece clamping groove (19) can slide along the sliding opening (15).

9. A regulatable intra-abdominal pressure hemostatic device according to claim 1, wherein: the external hemostatic layer (3) is made of absorbable and degradable materials, and can be placed in the abdomen to be absorbed and degraded by the body.

10. A regulatable intra-abdominal pressure hemostatic device according to claim 1, wherein: the inner compression layer (4) is made of flexible materials such as rubber, latex, silica gel, plastic and the like.

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