CN110301994B

CN110301994B - Manual blind flap device

Info

Publication number: CN110301994B
Application number: CN201910725312.1A
Authority: CN
Inventors: 范圣先; 管文贤
Original assignee: Nanjing Drum Tower Hospital
Current assignee: Nanjing Drum Tower Hospital
Priority date: 2019-08-07
Filing date: 2019-08-07
Publication date: 2024-01-26
Anticipated expiration: 2039-08-07
Also published as: CN110301994A

Abstract

The invention relates to a manual ileocecal valve device, which comprises an intestinal canal tectorial membrane bracket, a prosthetic valve and a pressure monitoring and controlling component; the intestinal canal tectorial membrane bracket comprises a tubular reticular bracket and annular air bags arranged at two ends of the reticular bracket; the annular air bag is provided with an air injection port with a sealing structure and an air injection pipe, and a one-way valve is arranged in the air injection pipe; a film is arranged on the outer wall surface of the reticular bracket; the artificial valve is fixed at the middle position inside the tubular mesh bracket through a fixing ring, and a valve shaft extending longitudinally along the outflow direction is defined between the inflow end and the outflow end; the prosthetic valve includes three valve leaflets and a frame assembly for supporting the valve leaflets and defining a plurality of commissure portions positions. The device can well reconstruct the ileocecal valve and more accord with the physiological state, and can play roles in resisting reflux and delaying the emptying of the content of the small intestine. In addition, the device can also monitor the pressure in the intestinal cavity in real time and adjust the pressure, so that the occurrence of mechanical intestinal obstruction is avoided.

Description

Manual blind flap device

Technical Field

The invention relates to the technical field of intestinal canal reconstruction medical treatment, in particular to an artificial ileocecal valve device.

Background

The human ileocecal valve has sphincter function, which not only controls chyme to slowly enter the large intestine, but also ensures that chyme stays in the small intestine for a sufficient time and is fully digested and absorbed; at the same time, the colon content can be prevented from flowing back into the small intestine, and the effects of bacterial translocation and overgrowth of bacteria in the small intestine are avoided. Clinically, ileocecal valve is usually resected due to some diseases, which causes a certain degree of physiological dysfunction of intestinal tract. After the ileocecal valve is resected, the effects of delaying the small intestine discharge and resisting the reflux are lost, on one hand, the digestive and absorptive dysfunction is easy to be caused, and a series of complications such as intractable diarrhea, malnutrition, weight loss, growth and development retardation, fat-soluble vitamins (vitamin A, D, E, K) and vitamin B are generated ₁₂ Absorption disorders, and the like; on the other hand, the colon content containing a large amount of bacteria is caused to flow back, and the secondary intestinal flora is disturbed, so that bile salts cannot be combined, further the increase of intestinal lumen fluid secretion is promoted, a large amount of exudative diarrhea and bile salt bank consumption are generated, and malabsorption and overgrowth of bacteria in the small intestine are finally caused. In addition, overgrowth of bacteria in the small intestine will cause impaired barrier function of intestinal mucosa, aggravate the occurrence and development of intestinal infection, and severe cases even present with intestinal liver damage and intestinal sepsis.

In order to improve physiological dysfunction of intestinal canal after ileocecal valve excision, as early as 90 th century, various attempts of simulating ileocecal valve functions are made by various scholars at home and abroad, including small intestine section inversion operation, intestinal loop anastomosis operation, intestinal canal constriction operation, small intestine invagination anastomosis operation and the like, but the whole effect is not ideal. In addition, due to the limitation of the scientific and technical level at the moment, the pressure of the ileocecum cannot be monitored in real time and regulated in vitro, so that the risk of mechanical intestinal obstruction is easily caused. For a variety of objective reasons, no artificial ileocecal valve has been studied for more than a decade since the 21 st century. In long-term clinical practice, it is increasingly appreciated that ileocecal valve resection severely affects the quality of life and disease prognosis of patients. Especially for patients with extensive small intestine excision and right half-colon excision, complications such as intractable diarrhea, nutrient digestion and absorption disorder, malnutrition and the like are often accompanied. Thus, how to better reconstruct the ileocecal valve and bring it closer to physiological conditions has become an important issue to be addressed in treating ileocecal valve resected patients.

Disclosure of Invention

The invention aims to construct an artificial ileocecal valve device which can well reconstruct the ileocecal valve and is more in line with the physiological state, and can play roles in resisting reflux and delaying the emptying of the content of small intestine. In addition, the intestinal pressure can be monitored and regulated in real time, and mechanical intestinal obstruction is avoided.

In order to achieve the above purpose, the technical scheme provided by the invention is as follows:

a manual back-blind valve device, which comprises an intestinal canal tectorial membrane bracket, a manual valve and a pressure monitoring and controlling component; the intestinal canal tectorial membrane bracket comprises a tubular reticular bracket and annular air bags arranged at two ends of the reticular bracket; the annular air bag is provided with an air injection port with a sealing structure and an air injection pipe, and a one-way valve is arranged in the air injection pipe; a film is arranged on the outer wall surface of the reticular bracket; the prosthetic valve includes an inflow end, an outflow end, a fixation ring, valve leaflets, a commissure portion, and a frame assembly; the artificial valve is fixed at the middle position inside the tubular mesh bracket through a fixing ring, and a valve shaft extending longitudinally along the outflow direction is defined between the inflow end and the outflow end; the prosthetic valve includes three valve leaflets and a frame assembly for supporting the valve leaflets and defining a plurality of commissure portions, the commissure portions being cantilevered structures mounted on a fixation ring, tips of the commissure portions being movable relative to the fixation ring, the valve leaflets She Tongguo commissure portions being connected to the frame assembly, the commissure portions allowing the valve to move independently of the fixation ring when the fixation ring is secured to a tubular mesh stent.

Further, the head end of the reticular stent is in a mushroom head shape, and the diameter of the annular air bag is larger than the outer diameter of the head end of the reticular stent.

Further, the pressure monitoring control assembly comprises a pressure sensing controller and an external wireless monitoring controller which are positioned on the side wall of the inflow end of the artificial valve.

Further, the pressure monitoring control assembly comprises a first electronic control system and a second electronic control system; the first electronic control system comprises a first singlechip, a first power supply, a pressure induction controller, a first wireless receiver and a first wireless transmitter; the first power supply supplies power to the first electronic control system; the pressure sensing controller is a ceramic piezoelectric plate, the pressure sensor is provided with a wireless signal transmitter, and the wireless signal transmitter is connected with a control terminal in a wireless way; the pressure sensing controller, the first wireless receiver and the first wireless transmitter are in signal connection with the first singlechip.

Further, the second electronic control system comprises a second singlechip, a second power supply, a man-machine interaction operation device, a display, a second wireless receiver and a second wireless transmitter; the second power supply supplies power for the second electronic control system, and the man-machine interaction operation device, the display, the second wireless receiver and the second wireless transmitter are connected with the second singlechip through signals.

Further, the external wireless monitoring controller comprises a display, a wireless transmitting/receiving window, a box body and a man-machine interaction operation key.

Further, the material of the reticular stent is cobalt-based alloy, nickel-based alloy or titanium alloy.

Furthermore, the outer wall surface of the reticular stent is also covered with a layer of coating for preventing intestinal mucosa tissues of a human body from being embedded into the reticular stent, and the coating is made of polyvinyl fluoride.

Further, the annular air bag is sleeved on the outer wall surface of the head end of the reticular bracket or is directly attached to the end surface of the head end of the reticular bracket.

Further, the pressure sensing controller controls the valve opening default pressure to 20mmHg.

Compared with the prior art, the invention has the beneficial effects that:

the artificial ileocecal valve device can well reconstruct the ileocecal valve and more accord with the physiological state, and can play roles in resisting reflux and delaying the emptying of the content of the small intestine. In addition, the device is provided with pressure monitoring and adjusting equipment, so that the pressure in the intestinal cavity can be monitored and adjusted in real time, and mechanical intestinal obstruction is avoided. For patients who do extensive intestinal resection or right half-colon resection, the artificial ileocecal valve slows down the emptying speed of the small intestine to the colon, avoids or reduces digestive absorption disorder, maintains relative sterility in the small intestine, accords with physiological functions comparatively, and can obviously improve complications such as intractable diarrhea, malnutrition, dysbacteriosis and the like which are caused by the ileocecal valve resection.

Drawings

Fig. 1: schematic structural diagram of intestinal canal tectorial membrane stent.

Fig. 2: a schematic structural diagram of the prosthetic valve.

Fig. 3: the first electronic control system is structurally and schematically shown.

Fig. 4: the second electronic control system is structurally schematic.

Fig. 5: the structure of the in-vitro pressure monitoring and controlling device is schematically shown.

In the figure: 1-mesh support, 2-annular gasbag, 3-tectorial membrane, 4-check valve, 5-gas injection pipe, 6-sealing plug, 7-solid fixed ring, 8-valve lobule, 9-commissure part, 10-display, 11-wireless transmission/receiving window, 12-box, 13-man-machine interaction operation button.

Detailed Description

The invention will be further illustrated with reference to specific examples.

A artificial ileocecal valve device, which comprises an intestinal canal tectorial membrane 3 bracket, a artificial valve and a pressure monitoring control component; the intestinal canal tectorial membrane 3 bracket comprises a tubular reticular bracket 1 and annular air bags 2 arranged at two ends of the reticular bracket 1; the head end of the reticular stent 1 is in a mushroom head shape, and the diameter of the annular air bag 2 is larger than the outer diameter of the head end of the reticular stent 1; the annular air bag 2 is provided with an air injection port with a sealing structure and an air injection pipe 5, and a one-way valve 4 is arranged in the air injection pipe 5; a film 3 is arranged on the outer wall surface of the reticular bracket 1; the prosthetic valve comprises an inflow end, an outflow end, a fixation ring 7, valve leaflets 8, commissure portions 9, and a frame assembly; the artificial valve is fixed at the middle position inside the tubular mesh bracket 1 through a fixing ring 7, and a valve shaft extending longitudinally along the outflow direction is defined between the inflow end and the outflow end; the prosthetic valve comprises a plurality of valve leaflets 8 and a frame assembly for supporting the valve leaflets 8 and defining the positions of a plurality of commissure portions 9, the commissure portions 9 being cantilever-like structures mounted on the fixation ring 7, the tips of the commissure portions 9 being movable relative to the fixation ring 7, the valve leaflets 8 being connected to the frame assembly by the commissure portions 9, the commissure portions 9 allowing the valve to move independently of the fixation ring 7 when the fixation ring 7 is fixed to the tubular mesh support 1.

The pressure monitoring control assembly comprises a pressure sensing controller and an external wireless monitoring controller which are positioned on the side wall of the inflow end of the artificial valve.

The pressure monitoring control assembly comprises a first electronic control system of a pressure sensing controller and a second electronic control system of an external wireless monitoring controller; the first electronic control system comprises a first singlechip, a first power supply, a pressure induction controller, a first wireless receiver and a first wireless transmitter; the first power supply supplies power for the first electronic control system, and the pressure sensing controller, the first wireless receiver and the first wireless transmitter are in signal connection with the first singlechip.

The second electronic control system comprises a second singlechip, a second power supply, a man-machine interaction operation device, a display 10, a second wireless receiver and a second wireless transmitter; the second power supply supplies power to the second electronic control system, and the man-machine interaction operation device, the display 10, the second wireless receiver and the second wireless transmitter are in signal connection with the second singlechip.

The external wireless monitoring controller comprises a display 10, a wireless transmitting/receiving window 11, a box body 12 and a man-machine interaction operation key 13.

The mesh stent 1 is made of cobalt-based alloy, nickel-based alloy or titanium alloy, has good biocompatibility and elasticity, and the intestinal canal stent prepared from the materials has excellent performance, has good elasticity in a body temperature environment, can deform along with normal intestinal canal peristalsis, and ensures that the intestinal canal is kept smooth and has no uncomfortable feeling. The outer wall surface of the reticular stent 1 is also covered with a layer of film 3 made of polyvinyl fluoride, so that intestinal mucosa tissues of a human body can be prevented from being embedded into the reticular stent 1, and the artificial ileocecal valve can be conveniently taken out in the future. The head end of the reticular stent 1 is in a mushroom head shape, so that the expansion force of the head end of the whole intestinal stent can be increased, and the whole intestinal stent can be more stably fixed in the intestinal tract. The head end of the reticular bracket 1 is also provided with an annular air bag 2, and the annular air bag 2 can be sleeved on the outer wall surface of the head end of the reticular bracket 1 or directly attached to the end surface of the head end of the reticular bracket 1. The sealing structure of the inflation tube of the annular air bag 2 is a one-way valve 4, the one-way valve 4 is connected with an air injection tube 5, and a doctor can conveniently inflate the annular air bag 2 through the air injection tube 5. When the annular air bag 2 is fully inflated, the air injection pipe 5 is cut off only from the connection part of the air injection pipe 5 and the one-way valve 4.

Before the artificial ileocecal valve is implanted into the intestinal tract, the annular air bag 2 is in an uninflated state, and after the artificial ileocecal valve is implanted, the outer diameter of the head end of the reticular stent 1 is increased by the annular air bag 2 in an inflated state, so that the whole intestinal stent is stably hung at the joint of the small intestine and the colon, and displacement or falling off caused by peristaltic motion of the intestinal tract is avoided. The shape of the mushroom head at the head end of the annular air bag 2 and the net-shaped bracket 1 complement each other: when the head end of the mesh stent 1 is not in a mushroom head shape, the annular air bag 2 is easy to be deformed by intestinal pressure, so that the intestinal stent is likely to shift; when the head end of the mesh stent 1 is in the shape of a mushroom head, but the annular balloon 2 is not provided, the size of the mushroom head must be increased in order to prevent the intestinal stent from being displaced, and after the mushroom head becomes large, the removal of the intestinal stent in the future is inconvenient. The annular air bag 2 and the mushroom head are arranged together, so that the whole intestinal canal bracket can be more stably fixed in the intestinal canal, and the intestinal canal bracket can be taken out in the future conveniently.

The pressure monitoring control assembly comprises a pressure sensing controller, a first electronic control system, a first power supply, a second electronic control system and a second power supply. The first electronic control system is shown in fig. 3, and consists of a first single chip microcomputer, and a first wireless receiver and a first wireless transmitter which are respectively connected with the first single chip microcomputer. The second electronic control system is shown in fig. 4 and 5, and is composed of a second singlechip, a second wireless receiver, a second wireless transmitter, a man-machine interaction operation key 13 and a display 10, wherein the second wireless receiver, the second wireless transmitter, the man-machine interaction operation key 13 and the display 10 are respectively connected with the second singlechip. The pressure sensing controller senses the pressure in the small intestine at the inflow end of the intestinal support in real time, controls the opening and closing of the artificial valve according to the pressure value in the small intestine, when the pressure value in the small intestine is higher than a preset pressure value, the artificial valve is automatically opened, the content in the small intestine enters the colon, the pressure in the small intestine is reduced to be lower than the preset value, the artificial valve is closed, and the pressure state in the small intestine is adjusted in real time. The pressure sensing controller controls the valve opening default pressure to be 20mmHg (the static pressure of the ileocecum area under the physiological state is about 20 mmHg); the pressure sensing controller is in wireless connection with the external second electronic control system, monitors the pressure in the small intestine at the inflow end in real time, and adjusts according to the symptoms of a patient if necessary.

The implantation method of the artificial ileocecal valve comprises the following steps: the artificial ileocecal valve is implanted at the junction of the small intestine and colon in the case of surgical open surgery. After the artificial ileocecal valve is implanted, the annular air bag 2 is inflated by a needle cylinder or other inflation devices through an air injection pipe 5; then the gas injection tube 5 is cut off along the connection part of the gas injection tube 5 and the one-way valve 4 by using the instrument.

The present invention is not limited to the preferred embodiments, and any simple modification, equivalent replacement, and improvement made to the above embodiments by those skilled in the art without departing from the technical scope of the present invention, will fall within the scope of the present invention.

Claims

1. A manual ileocecal valve device, characterized in that: comprises an intestinal canal tectorial membrane bracket, a prosthetic valve and a pressure monitoring control component; the intestinal canal tectorial membrane bracket comprises a tubular reticular bracket and annular air bags arranged at two ends of the reticular bracket; the annular air bag is provided with an air injection port with a sealing structure and an air injection pipe, and a one-way valve is arranged in the air injection pipe; a film is arranged on the outer wall surface of the reticular bracket; the prosthetic valve includes an inflow end, an outflow end, a fixation ring, valve leaflets, a commissure portion, and a frame assembly; the artificial valve is fixed at the middle position inside the tubular mesh bracket through a fixing ring, and a valve shaft extending longitudinally along the outflow direction is defined between the inflow end and the outflow end; the prosthetic valve includes three valve leaflets and a frame assembly for supporting the valve leaflets and defining a plurality of commissure portions locations; the connecting part is of a cantilever structure arranged on the fixed ring, and the tip end of the connecting part can move relative to the fixed ring; the valve leaflet She Tongguo commissure portions are attached to a frame assembly; the commissure portions allow the valve to move independently of the fixation ring when the fixation ring is secured to the tubular mesh stent; the head end of the reticular stent is in a mushroom head shape, and the diameter of the annular air bag is larger than the outer diameter of the head end of the reticular stent; the pressure monitoring control assembly comprises a pressure sensing controller and an external wireless monitoring controller which are positioned on the side wall of the inflow end of the artificial valve.

2. A manual ileocecal valve device according to claim 1, characterized in that: the pressure monitoring control assembly comprises a first electronic control system and a second electronic control system; the first electronic control system comprises a first singlechip, a first power supply, a pressure induction controller, a first wireless receiver and a first wireless transmitter; the first power supply supplies power to the first electronic control system; the pressure sensing controller is a ceramic piezoelectric plate, the pressure sensor is provided with a wireless signal transmitter, and the wireless signal transmitter is connected with a control terminal in a wireless way; the pressure sensing controller, the first wireless receiver and the first wireless transmitter are in signal connection with the first singlechip.

3. A manual ileocecal valve device according to claim 2, characterized in that: the second electronic control system comprises a second singlechip, a second power supply, a man-machine interaction operation device, a display, a second wireless receiver and a second wireless transmitter;

the second power supply supplies power for the second electronic control system, and the man-machine interaction operation device, the display, the second wireless receiver and the second wireless transmitter are connected with the second singlechip through signals.

4. A manual ileocecal valve device according to claim 3, characterized in that: the external wireless monitoring controller comprises a display, a wireless transmitting/receiving window, a box body and a man-machine interaction operation key.

5. A manual ileocecal valve device according to claim 1, characterized in that: the material of the reticular bracket is cobalt-based alloy, nickel-based alloy or titanium alloy.

6. A manual ileocecal valve device according to claim 1, characterized in that: the outer wall surface of the reticular stent is covered with a layer of coating film which is used for preventing intestinal mucosa tissues of a human body from being embedded into the reticular stent, and the coating film is made of polyvinyl fluoride.

7. A manual ileocecal valve device according to claim 1, characterized in that: the annular air bag is sleeved on the outer wall surface of the head end of the reticular bracket or is directly attached to the end surface of the head end of the reticular bracket.

8. A manual ileocecal valve device according to claim 1, characterized in that: the pressure sensing controller controls the valve opening default pressure to be 20mmHg.