CN106580387B - Medical body cavity internal pressure device - Google Patents

Abstract

Medical body cavity internal pressure device, including an openable and closable pressure umbrella. The pressure umbrella includes: a plurality of main ribs; an umbrella membrane attached to the plurality of main ribs; a fixed rod; a plurality of first branch ribs; and a plurality of second branch ribs, each second The proximal end of the branch rib is connected to the second end of the fixed rod. The device can significantly increase the gastric fundus compression area and provide low-pressure interval compression, which can ensure the self-blood supply of the esophagus and gastric fundus pressured mucosa without causing mucosal necrosis. After placement, further gastroscopy can be performed through the esophageal stent and the gastric fundus umbrella hollow channel. It provides the possibility of diagnosis and treatment for hemostasis under gastroscopy and hemostasis of bleeding points outside the compressed parts; it is easy to place and remove; it can provide long-term compression treatment or preventive treatment of bleeding in patients with severe varicose veins, and expands the treatment indications.

Description

Medical body cavity internal pressure device

Technical field

The present invention relates to a pressure or hemostasis device for human body cavity, especially near the fundus of the digestive tract and stomach.

Background technique

Approximately 1.2 million people die from liver cirrhosis in the world every year, and the number is increasing year by year. Most of the causes are esophageal and gastric variceal bleeding caused by liver cirrhosis. Commonly used hemostasis methods include drugs, equipment, interventional surgery, and laparotomy. For the acute treatment of acute severe bleeding, the current internationally preferred method is three-lumen two-sac tubes, also known as Sengstaken-Blakemore tubes or Minnesota tubes, for compression and hemostasis. A few doctors use Linton-Nachlas tubes (which only have a gastric balloon of about 500 ml). , no esophageal balloon) compression to stop bleeding. Although the above-mentioned hemostatic devices have played an important role in most clinical esophageal and gastric variceal bleeding for a long time, many problems have been discovered during their use. For example, common complications include esophageal and gastric fundus mucosal necrosis, mucosal ulcers, Secondary avulsion bleeding, rare complications include esophageal rupture, airway suffocation, etc. Other disadvantages include difficulty in catheter placement, ineffective compression, difficulty in adjusting compression, rupture of the balloon, obstruction of further gastroscopy, etc.

In addition, as shown in FIG. 1 , the fundus 60 of the human digestive tract is closely adjacent to the end of the esophagus 50 . When bleeding occurs near the fundus of the stomach, although existing bladder tubes or other hemostatic devices can enter the area to compress and stop bleeding, their local pressure is usually not adjustable. Therefore, there is an urgent need for such hemostatic equipment or devices during the process of hemostasis at the fundus of the stomach, the pressure exerted on the bleeding site at the fundus of the stomach can be adjusted accordingly according to actual needs during the process of hemostasis.

Contents of the invention

The object of the present invention is to provide a medical body cavity internal pressure device, which can be used, for example, to apply pressure to the fundus of the digestive tract and stomach to stop bleeding, and to overcome one or more of the above-mentioned deficiencies.

The medical body cavity internal pressure applying device of the present invention includes an openable and closable pressure applying umbrella with an umbrella top and an opening and closing end. The pressure applying umbrella includes:

Multiple main ribs converge toward the top of the pressure umbrella when the pressure umbrella is opened;

An umbrella membrane attached to the plurality of main umbrella ribs;

a fixed rod having a first end and a second end, wherein the first end of the fixed rod is arranged adjacent to the top of the pressure umbrella, and the second end of the fixed rod is arranged adjacent to the opening and closing end of the pressure umbrella;

There are a plurality of first branch ribs, each first branch rib has a proximal end and a distal end, wherein the proximal end of each first branch rib is fixedly connected to the first end of the fixed rod and the distal end extends toward the top of the umbrella. And fixedly connected to the corresponding main umbrella rib; and

A plurality of second branch ribs, each second branch rib has a proximal end and a distal end, wherein the proximal end of each second branch rib is connected to the second end of the fixed rod and the distal end extends toward the top of the umbrella and Fixedly connected to the corresponding main umbrella rib,

The first branch rib and the second branch rib are made of elastic material, the connection point between the first branch rib and the main umbrella rib is closer to the top of the umbrella than the connection point between the second branch rib and the main umbrella rib, and An opening is formed at the top of the umbrella.

Due to the spread configuration of the main ribs, the device of the present invention provides low pressure spaced compression without impeding microscopic examination.

According to one embodiment of the present invention, the medical body cavity internal pressure applying device may further include a radially expandable cylindrical stent or cylindrical stent formed with a hollow channel, and the cylindrical stent is connected to the top end of the pressure applying umbrella, so that the cylindrical stent The hollow channel is connected to the opening at the top of the umbrella of the pressure umbrella. The cylindrical stent is preferably formed into a mesh structure so that it can also provide low-pressure compartmental compression to the esophagus.

According to an embodiment of the present invention, a connection transition part may be formed between the cylindrical support and the top of the pressure umbrella. When the cylindrical support is in an expanded state, the outer diameter of the connection transition part is smaller than the outer diameter of the cylindrical support. . The connection transition part is preferably a frusto-conical part, with the tapered end of the frusto-conical part facing the top of the pressure umbrella.

According to an embodiment of the present invention, the proximal end of each second branch rib is longitudinally slidably connected to the second end of the fixed rod. In this case, a plurality of longitudinal slide grooves may be provided at circumferential intervals near the second end of the fixed rod to receive corresponding second branch ribs.

The medical body cavity internal pressure applying device of the present invention may further include a plurality of adjustment lines, each adjustment line is connected to the proximal end of the second branch rib and extends at least through the opening of the top end of the pressure applying umbrella.

According to a further preferred embodiment of the present invention, each slide groove of the fixed rod can be provided with a series of stop mechanisms, such as groove diameter narrowing parts, along the longitudinal direction to stop the proximal end of the second branch rib that slides thereto. The longitudinal slide groove is preferably provided as a blind groove formed on the circumferential wall of the fixed rod to avoid entanglement between the adjustment wires.

According to one embodiment of the present invention, the medical body cavity internal pressure applying device may also include a removable sleeve, which is coated on the pressure applying umbrella and/or the cylindrical stent to keep it in a closed state or a contracted state, and when being withdrawn After removal, the pressure umbrella and/or the cylindrical stent are automatically released to form an open or expanded state.

According to an embodiment of the present invention, the first branch ribs, the second branch ribs and/or the cylindrical bracket can be at least partially made of shape memory alloy materials, so that the pressure umbrella and/or can be made by changing the temperature. The cylindrical stent returns to its closed or retracted state. The elastic memory alloy preferably at least partially loses its elasticity or returns to its original shape at about 50°C (40°C to 60°C).

According to an embodiment of the present invention, the umbrella membrane may be made of medical polymer material. In addition, the umbrella membrane can also use a mesh membrane or a mesh membrane to further provide low-pressure interval compression. Additionally, the outer perimeter of the membrane can extend beyond the ends of the main ribs to provide soft edge protection.

According to one embodiment of the present invention, the cylindrical stent can also be covered with or attached with a medical polymer or biomaterial film to reduce irritation to the esophagus. In this case, the umbrella membrane and the cylindrical stent membrane can also be integrated to form an elastic membrane or an elastic mesh membrane to facilitate assembly (simply put it on).

According to one embodiment of the present invention, the main umbrella rib can be formed into a flat elongated shape and have a plurality of perforations formed thereon, thereby further improving the low-pressure spaced compression effect.

Compared with commonly used three-lumen two-bag tubes and other hemostatic devices with unadjustable local pressure, the device of the present invention can significantly increase the gastric fundus compression area, and can provide low-pressure interval compression, which can ensure the self-blood supply of the esophagus and gastric fundus compressed mucosa. It does not cause mucosal necrosis; after placement, further gastroscopy can be performed through the esophageal stent and the gastric fundus hollow channel, which provides diagnosis and treatment possibilities for hemostasis under gastroscopy and hemostasis at bleeding points other than the compressed parts; it is easy to place and take out, and can be removed through Temperature affects the shape of the memory alloy (for example, by letting the patient drink hot water between 40°C and 60°C to restore the memory alloy material to its original shape) and facilitates removal; observation during placement is simple and can significantly reduce complications related to, for example, three-lumen two-capsule tubes, especially It can avoid bleeding complications after avulsion when taking out the three-lumen two-capsule tube; the device can be placed for a long period of time, in addition to providing acute phase treatment, it can provide long-term compression treatment, and can be used as a preventive treatment for bleeding in patients with severe esophageal and gastric varices. treatment, expanding the treatment indications.

Description of the drawings

Figure 1 is a simple structural diagram of the human digestive tract near the fundus;

Figure 2 is a schematic diagram of the opening or working state of the medical body cavity internal pressure device of the present invention; and

Figure 3 is a schematic diagram of the medical body cavity internal pressure applying device of the present invention in a closed or pre-use state.

Detailed ways

The present invention will be further described below in conjunction with the accompanying drawings. Those skilled in the art should understand that the embodiments described below are only illustrative of the present invention and are not intended to limit it in any way. For example, although the present invention is described by applying pressure to the fundus of the digestive tract and stomach to stop bleeding, it can obviously also be used in other suitable locations or pressure applications.

As shown in the specific embodiment of FIG. 2 , the medical body cavity internal pressure applying device of the present invention includes a cylindrical bracket 3 and an openable and closable umbrella 5 as well as a connection transition part 4 located between the two.

The cylindrical stent 3 usually has a cylindrical outer contour, is formed with a hollow channel and is radially expandable. The cylindrical stent 3 is preferably made of elastic material such as shape memory alloy elastic material. In addition, the cylindrical stent 3 shown in the figure is formed into a mesh structure, thereby being able to provide low-pressure spaced compression.

The openable and closable umbrella 5 has an upper umbrella top and a lower opening and closing end. An opening is formed on the top of the umbrella and communicates with the hollow channel of the cylindrical bracket 3 through the hollow connecting transition portion 4 . When the cylindrical stent 3 is in the expanded state, the outer diameter of the connecting transition portion 4 is smaller than the outer diameter of the cylindrical stent. The connection transition part 4 is shown to be similar to a frustum, and its tapered end faces the top of the openable and closable umbrella 3 .

The openable and closable umbrella 5 includes a plurality of main ribs 9 , a plurality of first branch ribs 7 , a plurality of second branch ribs 8 and a fixed rod 6 .

The main ribs 9 converge toward the top of the openable and closable umbrella 5 when the openable and closable umbrella is in an open state. The main rib 9 can be made of a suitable material such as titanium or a shape memory alloy elastic material. The main rib 9 can be formed into a flat elongated shape. A plurality of perforations can also be further formed on the flat elongated main umbrella rib 9 . The length of the main rib 9 can be about 9cm.

An umbrella surface or umbrella film 10 is attached to the main umbrella rib 9. The umbrella film 10 can be made of medical polymer materials or human body absorbable and degradable materials. Although not shown, the umbrella membrane 10 may also be a mesh membrane or a mesh membrane to further provide low pressure spaced compression. The outer periphery of the umbrella membrane 10 may extend slightly beyond the ends of the main ribs 9 to provide soft edge protection.

In addition, the cylindrical stent 3 can also be covered with or attached with a medical polymer or biomaterial film (not shown in the figure) to reduce stimulation to the esophagus 50 . In this case, the umbrella membrane 10 and the cylindrical stent membrane may be integrated to form an elastic membrane or an elastic mesh membrane.

The fixed rod 6 shown in the figures has an upper first end and a lower second end. The first end is arranged adjacent to the top of the openable and closable umbrella 5 , and the second end is arranged adjacent to the opening and closing end of the openable and closable umbrella 5 . The length of the fixed rod 6 can be about 5cm.

Each first branch rib 7 has a proximal end and a distal end. The proximal end is fixedly connected to the first end of the fixed rod 6 and the distal end extends toward the top of the umbrella and is fixedly connected to the corresponding main rib 9 . In this way, the fixed rod 6 and the main rib 9 are fixed to each other through the first branch rib 7 . The first branch rib 7 can be formed into a round rod shape, and the length can be about 4cm.

Each second branch rib 8 also has a proximal end and a distal end. The proximal end is longitudinally slidably connected to the second end of the fixed rod 6 and the distal end extends toward the top of the umbrella and is fixedly connected to the corresponding main rib 9 . The second branch rib 8 can also be formed into a round rod shape, and the length can be about 6cm. Both the first branch ribs 7 and the second branch ribs 8 can be made of shape memory alloy elastic material.

The connection point of the first branch rib 7 and the main rib 9 is closer to the top of the umbrella than the connection point of the second branch rib 8 and the main rib 9 , so that the connection point of the first branch rib 7 forms the first inner ring. The connection points of the second branch ribs 8 form the second outer ring. An included angle of about 40° can be formed between the first branch rib 7 and the fixed rod.

A plurality of longitudinal slide grooves (not specifically shown) are provided at circumferential intervals near the second end of the fixed rod 6 to receive the proximal ends of the corresponding second branch ribs 8 . A series of stop mechanisms such as groove diameter narrowing portions 12 can be provided on each chute along the longitudinal direction (up and down direction in the figure) to stop the proximal end of the second branch rib 8 sliding thereto. In this case, the proximal end of the second branch rib 8 may preferably be formed into an expansion head structure such as a hemispherical head. The longitudinal chute is preferably provided as a blind groove formed on the circumferential wall of the solid fixed rod 6 in order to avoid the entanglement phenomenon between the adjustment wires 1 which will be described below.

In order to facilitate the adjustment of the proximal end of the second branch rib 8 to slide longitudinally along the fixed rod 6, multiple adjustment wires 1 can be used. One end of each adjustment wire 1 is connected to the proximal end of the second branch rib 8, and the other end is connected to the proximal end of the second branch rib 8. A hollow channel extending through the opening at the top of the openable and closable umbrella 5 and the cylindrical bracket 3 . In order to prevent the adjustment wires 1 from being scattered and causing possible damage to the digestive tract, most of the adjustment wires 1 (in terms of their length) can be accommodated in a hose 11 .

As shown in Figure 3, the medical body cavity internal pressure device of the present invention can also include a removable sleeve or removable sleeve 2, which is wrapped around the openable and closable umbrella 5 and the cylindrical bracket 3 to keep it closed. state or contracted state, and after being extracted, the openable and closable umbrella 5 and the cylindrical bracket 3 are automatically released to form an open state or an expanded state. However, those skilled in the art will understand that any other suitable method can also be used to release the openable and closable umbrella 5 and the cylindrical bracket 3 to form an open or expanded state.

The following is a brief description of the use and working process of the medical body cavity internal pressure device of the present invention near the fundus of the digestive tract and stomach.

First, the device with the sleeve 2 is sent into the digestive tract near the fundus 60 of the digestive tract through the oral cavity or nasal cavity. After the position is determined by X-ray or bedside ultrasound, the sleeve 2 is withdrawn. At this time, the cylindrical stent 3 can be opened and closed. The umbrella 5 automatically expands or opens normally. Due to the relatively reduced outer diameter of the connecting transition portion 4, the entire device is stuck or positioned at the corresponding position of the esophagus 50 and the fundus of the stomach 60, and applies pressure to the varicose veins there to stop bleeding. Since the entire device is formed with a hollow channel that runs up and down, other inspections such as gastroscopy can still be performed at this time. In addition, the hemostatic device of the present invention can even be left in the patient's body for a short period of time to continue its hemostatic effect without affecting his normal life.

If you need to adjust the pressure exerted by the device on somewhere near the fundus of the stomach, pull the corresponding adjustment wire 1 upward, thereby driving the proximal end of the second branch rib 8 connected to it upward along the longitudinal chute provided on the outer circumference of the fixed rod 6 Slide until the groove diameter constriction 12 is at the height corresponding to the required pressure and is stopped there.

In addition, the pressure in multiple directions around the surface of the openable and closable umbrella 5 can be adjusted by adjusting different adjustment lines 1 in sequence, so that the entire umbrella surface can approximately fully fit and exert pressure on the varicose veins on the gastric fundus mucosal surface, thereby achieving sufficient Hemostatic effect.

Claims (7)

1. A medical body cavity internal pressure device, including an openable and closable pressure umbrella with an umbrella top and an opening and closing end. The pressure umbrella contains: Multiple main ribs converge toward the top of the pressure umbrella when the pressure umbrella is opened; An umbrella membrane attached to the plurality of main umbrella ribs; a fixed rod having a first end and a second end, wherein the first end of the fixed rod is arranged adjacent to the top of the pressure umbrella, and the second end of the fixed rod is arranged adjacent to the opening and closing end of the pressure umbrella; There are a plurality of first branch ribs, each first branch rib has a proximal end and a distal end, wherein the proximal end of each first branch rib is fixedly connected to the first end of the fixed rod and the distal end extends toward the top of the umbrella. And fixedly connected with the corresponding main umbrella rib; A plurality of second branch ribs, each second branch rib has a proximal end and a distal end, wherein the proximal end of each second branch rib is connected to the second end of the fixed rod and the distal end extends toward the top of the umbrella and Fixedly connected to the corresponding main ribs, the first branch ribs and the second branch ribs are made of elastic materials. The connection point between the first branch ribs and the main umbrella ribs is compared with the connection point between the second branch ribs and the main umbrella ribs. The connection point is closer to the top of the umbrella, and an opening is formed in the top of the umbrella; and A plurality of adjustment lines, each adjustment line is connected to the proximal end of the second branch rib and extends through the opening at the top of the pressure umbrella, The proximal end of each second branch rib is longitudinally slidably connected to the second end of the fixed rod, A plurality of longitudinal slide grooves are provided at circumferential intervals near the second end of the fixed rod to receive corresponding second branch ribs. 2. The medical body cavity internal pressure device according to claim 1, further comprising a radially expandable cylindrical stent formed with a hollow channel, the cylindrical stent is connected to the top of the pressure umbrella, so that the hollow channel of the cylindrical stent is connected to the top of the pressure umbrella. The openings at the top of the parachute are connected. 3. The medical body cavity internal pressure device according to claim 1, wherein there is a connection transition portion between the cylindrical stent and the top of the pressure umbrella, and when the cylindrical stent is in an expanded state, the outer diameter of the connection transition portion is smaller than the cylinder. The outer diameter of the bracket. 4. The medical body cavity internal pressure exerting device according to claim 3, wherein the connecting transition part is a frustoconical part, and the tapered end of the frustoconical part faces the top of the pressure umbrella. 5. The medical body cavity internal pressure device according to claim 1 or 2, further comprising a removable sleeve, which is coated on the pressure umbrella and/or the cylindrical stent to keep it in a closed state or a contracted state, and is in a closed state or a contracted state. After extraction, the pressure umbrella and/or the cylindrical stent are automatically released to form an open or expanded state. 6. The medical body cavity internal pressure exerting device according to claim 1 or 2, wherein the first branch ribs, the second branch ribs and/or the cylindrical bracket are at least partially made of shape memory alloy material, thereby being able to change the temperature by changing the temperature. Return the pressure umbrella and/or cylindrical support to the closed or retracted state. 7. The medical body cavity internal pressure exerting device according to claim 1, wherein the umbrella membrane is made of medical polymer material.