An oral continuous negative pressure drainage device for preventing and treating pharyngeal fistula

Abstract

The present invention discloses an oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device, which relates to the technical field of medical supplies. The present invention includes an insertion tube, and the insertion tube includes a drainage tube and an inflation tube arranged side by side; the front section of the insertion tube is a nasal insertion section, and the rear section is a hypopharyngeal insertion section; the nasal insertion section and the hypopharyngeal insertion section are detachably connected through a connecting piece; a plurality of drainage holes are provided on the side surface of the end of the drainage tube, an airbag is provided at the end of the inflation tube, and the airbag communicates with the inflation tube; a sponge is wrapped outside the drainage holes and the airbag. The present invention can effectively suck out the secretions in the hypopharynx, can appropriately compress the internal fistula opening, can create a negative pressure environment around the internal fistula opening, can effectively promote the healing of the internal fistula opening, and thus accelerate the rehabilitation process of the pharyngeal fistula.

Description

Technical Field

[0001] The present invention relates to the technical field of medical supplies, and particularly relates to an oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device. Background Art

[0002] Pharyngeal fistula, also known as pharyngocutaneous fistula, often occurs after total laryngectomy for laryngeal cancer or hypopharyngeal cancer. Specifically, it is manifested as a sinus formed by the connection between the hypopharynx and the esophageal cavity and the skin, and saliva or food overflows to the outside of the skin through this, forming a skin fistula. Its occurrence can prolong the hospital stay, increase medical costs, affect the doctor-patient relationship, and even endanger life due to arterial rupture and sepsis.

[0003] The treatment of pharyngeal fistula is divided into two types: conservative treatment and surgical treatment.

[0004] Conservative treatment: ① Phase I: Within 1 week after the appearance of the pharyngeal fistula, the treatment is mainly focused on drainage and cleaning, so it is also called the drainage and cleaning period; ② Phase II: Within 2 - 3 weeks after the appearance of the pharyngeal fistula, the treatment is mainly focused on pressure dressing, which can also be called the pressure dressing period; ③ Phase III: Within 4 - 6 weeks after the appearance of the pharyngeal fistula, most pharyngeal fistulas can heal during this period, which is called the healing period. If the pharyngeal fistula does not heal after more than 6 weeks, surgical intervention is required.

[0005] Surgical treatment: Commonly used clinical treatments include debridement and suture, and tissue repair methods.

[0006] Although about 60% - 80% of pharyngeal fistulas can be cured by conservative treatment, during conservative treatment, only pressure dressing can be performed on the external part of the neck at the plane where the internal fistula opening is located or the skin fistula opening can be treated, and intervention is carried out "downstream" of the pharyngeal fistula. Although the internal fistula opening is the main cause of pharyngeal fistula, because it is located in the deeper part of the hypopharynx, it cannot be effectively treated. Moreover, the internal fistula opening is constantly soaked in saliva for a long time, resulting in slow recovery and too long treatment time. After conservative treatment, about 40% of patients still need surgical treatment.

[0007] Negative pressure wound therapy technology is commonly used to treat difficult-to-heal wounds and sores. This technology can improve the speed and quality of wound healing by promoting wound blood circulation, promoting the expression of various cytokines in the wound tissue, reducing tissue edema, and reducing the bacterial load in the wound, and can effectively promote the healing of wounds and sores. However, because the internal fistula opening is located in the deeper part of the hypopharynx and it is difficult to form a closed negative pressure environment like wounds on the skin, the above-mentioned negative pressure wound therapy technology cannot be well applied in the healing process of the internal fistula opening.

[0008] In summary, during the conservative treatment of pharyngeal fistula, due to the deep location of the internal fistula opening in the throat, it is difficult for the internal fistula opening to heal and the recovery is slow. The negative pressure wound treatment technology has a good effect on wound healing, but it is difficult to be well applied to the healing process of the internal fistula opening due to the deep location of the internal fistula opening. Therefore, combining the negative pressure wound treatment technology and designing a device that can effectively promote the healing of the internal fistula opening is of great significance for the treatment of pharyngeal fistula. Summary of the Invention

[0009] In order to solve the problems existing in the above-mentioned prior art, the purpose of the present invention is to provide an oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device. The present invention can effectively suck out the secretions in the lower pharynx, can appropriately compress the internal fistula opening, and can form a negative pressure environment around the internal fistula opening, which can effectively promote the healing of the internal fistula opening and thus accelerate the rehabilitation process of pharyngeal fistula.

[0010] An oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device described in the present invention includes an insertion tube, and the insertion tube includes a drainage tube and an inflation tube arranged side by side; the front section of the insertion tube is a nasal insertion section, and the rear section is a lower pharynx insertion section; the nasal insertion section and the lower pharynx insertion section are detachably connected through a connector; a plurality of drainage holes are arranged on the side surface of the end of the drainage tube, and an airbag is arranged at the end of the inflation tube, and the airbag is communicated with the inflation tube; a sponge is coated outside the drainage holes and the airbag.

[0011] Preferably, the connector is cylindrical, and a first connection hole and a second connection hole are axially opened thereon. The aperture of the first connection hole is adapted to the outer diameter of the drainage tube, and the aperture of the second connection hole is adapted to the outer diameter of the inflation tube.

[0012] Preferably, the connector is made of rubber material.

[0013] Preferably, the sponge is an expandable sponge.

[0014] Preferably, the sponge is cylindrical, with a diameter of 1.2 - 1.5 cm and a length of 3 - 4 cm.

[0015] Preferably, the sponge is fixed on the drainage tube through a suture.

[0016] Preferably, an inflation valve is arranged at one end of the inflation tube away from the airbag, and the inflation valve is used to control the on-off of the inflation tube.

[0017] Preferably, the outer diameter of the drainage tube is 4.5 - 5.5 mm, and the outer diameter of the inflation tube is 0.8 - 1.2 mm.

[0018] The advantages of the oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device described in the present invention are as follows:

[0019] 1. In the present invention, a sponge and the end of a drainage tube are placed in the hypopharynx of a patient. Through the absorption of the sponge and the negative pressure suction of the drainage tube, secretions such as saliva in the hypopharynx can be effectively absorbed and drained, preventing the internal fistula orifice from being soaked in saliva for a long time, which is beneficial to the healing of the internal fistula orifice. The drainage tube can also continuously suck out the pus or gas in the fistula tract from the internal fistula orifice in the hypopharynx, preventing the formation of residual abscesses and dead spaces, facilitating the cleaning of the fistula tract wound surface, shortening the drainage and cleaning period, and then promoting the granulation growth of the fistula tract wound surface, enabling it to enter the healing period faster. It can cooperate with debridement and suture to suture the internal fistula orifice in alignment, significantly shortening the treatment cycle of pharyngeal fistula.

[0020] 2. After the sponge of the present invention is placed in the hypopharynx of the patient, the absorption of liquid will cause the volume of the sponge to increase. It can also be further enlarged by inflating the airbag. The enlarged sponge can appropriately compress the internal fistula orifice, reducing the wound surface and even closing the internal fistula orifice, which can promote the healing of the internal fistula orifice and thus accelerate the rehabilitation process of pharyngeal fistula.

[0021] 3. Negative pressure drainage is carried out by connecting a negative pressure device through a drainage tube to create a negative pressure environment around the internal fistula orifice of the patient. The negative pressure environment acts on the cell membrane, promoting cells to secrete vascular proliferation factors, etc., thereby stimulating the tissue to generate more new blood vessels. It can increase the blood flow and growth factors in the wound surface by increasing capillary filling, promoting white blood cells and fibroblasts to enter the wound surface. Among them, white blood cells can resist infection and produce growth factors, while fibroblasts can produce collagen to fill and repair the wound, reducing the number of bacteria on the wound surface. All these effects are beneficial to the healing of the internal fistula orifice and can thus accelerate the rehabilitation process of pharyngeal fistula. BRIEF DESCRIPTION OF THE DRAWINGS

[0022] Figure 1 is one of the schematic structural diagrams of an oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to the present invention;

[0023] Figure 2 is another schematic structural diagram of an oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to the present invention;

[0024] Figure 3 is Figure 1 the sectional view taken along the A-A direction in

[0025] Figure 4 is one of the schematic use state diagrams of an oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to the present invention;

[0026] Figure 5 is another schematic use state diagram of an oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to the present invention.

[0027] Description of reference numerals: 1 - insertion tube, 11 - nasal insertion section, 12 - hypopharyngeal insertion section, 2 - drainage tube, 21 - drainage holes, 3 - inflation tube, 4 - connecting piece, 5 - airbag, 6 - sponge, 7 - inflation valve. Detailed implementation manner

[0028] As Figures 1 - 3 shown, a transoral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to the present invention includes an insertion tube 1, and the insertion tube 1 includes a drainage tube 2 and an inflation tube 3 arranged side by side. Specifically, the drainage tube 2 and the inflation tube 3 extend in the same direction, and the outer peripheral surface of the drainage tube 2 is adhesively bonded to the outer peripheral surface of the inflation tube 3, but the lumens of the two tubes are separated from each other. The front section of the insertion tube 1 is a nasal insertion section 11, and the rear section is a hypopharyngeal insertion section 12. The nasal insertion section 11 and the hypopharyngeal insertion section 12 are detachably connected by a connecting piece 4. For details, please refer to Figure 2 , Figure 2 wherein, the left section of the insertion tube 1 is the nasal insertion section 11, and this tube section is inserted into the nasal cavity through the nostril during use. The right section of the insertion tube 1 is the hypopharyngeal insertion section 12, and this tube section is inserted into the hypopharynx through the oral cavity during use. A plurality of drainage holes 21 are provided on the side surface of the end of the drainage tube 2, and the drainage holes 21 communicate with the lumen inside the drainage tube 2. The drainage tube 2 can suck the liquid or gas outside the drainage tube 2 into the lumen through the drainage holes 21 on the side for drainage. An airbag 5 is provided at the end of the inflation tube 3. One end of the inflation tube 3 is communicated with the airbag 5, and the other end is provided with an inflation valve 7. The inflation valve 7 is used to control the on-off of the inflation tube 3. The airbag 5 can be inflated by supplying air through the inflation tube 3. A sponge 6 is wrapped outside the drainage holes 21 and the airbag 5. The sponge 6 is used to absorb liquid and expands when absorbing liquid and when the airbag 5 is inflated, so as to appropriately compress the internal fistula opening and play a role in reducing the wound surface.

[0029] The usage process of the present invention is specifically described as follows. The transoral continuous negative pressure drainage pharyngeal fistula prevention and treatment device of the present invention can be made into a disposable product and individually packaged. During use, open the outer package and separate the three components of the nasal insertion section 11, the connecting piece 4, and the hypopharyngeal insertion section 12, as specifically shown in Figure 2 shown. First, connect the hypopharyngeal insertion section 12 with the connecting piece 4 and set it aside. Then, as shown in Figure 4 shown, insert one end of the nasal insertion section 11 into one side of the nasal cavity. After inserting to a certain depth, use long forceps from the oral cavity to pull out the end of the nasal insertion section 11. Then connect the end of the nasal insertion section 11 pulled out from the oral cavity with the connecting piece 4, so as to connect the nasal insertion section 11 and the hypopharyngeal insertion section 12. Make the nasal insertion section 11 and the hypopharyngeal insertion section 12 be tightly connected, and check the airtightness of the connection position. After determining that the connection is tight, as shown in Figure 5As shown, the hypopharyngeal insertion section 12 is inserted from the patient's oral cavity to the patient's hypopharyngeal position. During the insertion process, it should be noted that the top of the sponge 6 should not exceed the back of the tongue to avoid causing the patient's pharyngeal reflex, and the end of the sponge 6 should support the piriformis sinus or the post-annular area. After the hypopharyngeal insertion section 12 is successfully inserted into the hypopharynx, the drainage tube 2 is connected to a negative pressure suction device at one end of the outside, and the pressure of the negative pressure suction device is adjusted to 60kpa, and a negative pressure is generated inside the drainage tube 2. Under the action of negative pressure, the drainage tube 2 generates an attraction force on the saliva, pus and other secretions in the hypopharynx through the drainage hole 21. The secretions penetrate and flow through the sponge 6, flow into the drainage tube 2 from the drainage hole 21, and are then sucked out by the negative pressure suction device. At the same time, the inflation valve 7 is opened, and the airbag 5 is inflated through the inflation tube 3 to expand the airbag 5. After the oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device of the present invention is inserted into the hypopharynx, the hypopharyngeal part undergoes the following specific changes.

[0030] First, the saliva, pus and other secretions in the hypopharynx are sucked out through the negative pressure suction device and the drainage tube 2, so as to reduce the amount of liquid secreted in the internal atrophy orifice.

[0031] Secondly, after the sponge 6 of the hypopharyngeal insertion section 12 is inserted into the hypopharynx, it can also absorb liquids such as secretions to a certain extent, and its volume will increase after absorbing the liquid. At the same time, the airbag 5 will also expand and become larger after inflation, stretching the sponge 6 so that the sponge 6 can further expand outward and become larger.

[0032] Thirdly, negative pressure drainage is performed at the hypopharynx through the negative pressure suction device and the drainage tube 2, so that a negative pressure environment is formed at the hypopharynx.

[0033] The above three changes bring about the following technical effects.

[0034] First, the negative pressure suction device performs negative pressure suction on the hypopharynx through the drainage tube 2, and the sponge 6 relies on its own water absorption characteristics to effectively absorb and remove saliva and other secretions from the hypopharynx, avoiding the internal fistula opening from being soaked in saliva for a long time, which is beneficial to the healing of the internal fistula opening. The drainage tube 2 can also continuously suck out pus or gas in the fistula from the internal fistula opening of the hypopharynx, avoiding the formation of residual abscesses and dead spaces, which is beneficial to the cleaning of the fistula wound surface, shortening the drainage cleaning period, and further promoting the growth of granulation tissue on the fistula wound surface, making it enter the healing period faster, and can cooperate with debridement and suture to suture the internal fistula opening in position, which can significantly shorten the treatment cycle of pharyngeal fistula.

[0035] Secondly, due to the characteristic of sponge 6 that it absorbs liquids, sponge 6 can also absorb secretions such as saliva in the pharynx to a certain extent, and after absorbing the liquid, the volume of sponge 6 will increase, and the airbag 5 can be inflated to make the sponge 6 further larger. After the sponge 6 becomes larger, it can appropriately compress the internal atrophy opening, reduce the wound surface, and even close the internal atrophy opening, which can promote the healing of the internal atrophy opening and thus accelerate the recovery process of pharyngeal atrophy.

[0036] Thirdly, a negative pressure drainage is carried out by connecting a negative pressure device through the drainage tube 2 to form a negative pressure environment around the internal fistula opening of the patient. The negative pressure environment acts on the cell membrane, which can promote the cells to secrete vascular proliferation factors, etc., thereby stimulating the tissue to generate more new blood vessels. The blood flow and growth factors of the wound surface can be increased by increasing the capillary filling, promoting white blood cells and fibroblasts to enter the wound surface. Among them, white blood cells can resist infection and produce growth factors, while fibroblasts can produce collagen to fill and repair the wound, reducing the number of bacteria on the wound surface. All these effects are beneficial to the healing of the internal fistula opening, and thus can accelerate the rehabilitation process of the pharyngeal fistula.

[0037] In this embodiment, the connector 4 is specifically cylindrical, and a first connection hole and a second connection hole are axially formed therein. The aperture of the first connection hole is adapted to the outer diameter of the drainage tube 2, and the aperture of the second connection hole is adapted to the outer diameter of the inflation tube 3. The first connection hole and the second connection hole are structures that communicate with each other on the side. Align the drainage tube 2 of the nasally inserted section 11 with the first connection hole, and align the inflation tube 3 with the second connection hole. Align the drainage tube 2 of the hypopharyngeal inserted section 12 with the other end of the first connection hole, and align the inflation tube 3 with the other end of the second connection hole. Then insert the nasally inserted section 11 and the hypopharyngeal inserted section 12 into both ends of the connector 4 respectively, so that the nasally inserted section 11 and the hypopharyngeal inserted section 12 can be connected. The above structure of the connector 4 can make the connection between the nasally inserted section 11 and the hypopharyngeal inserted section 12 stable and easy to disassemble and assemble.

[0038] Specifically, the connector 4 is made of rubber material. The rubber material has the characteristics of strong elasticity and softness. The strong elasticity can act on the hypopharyngeal inserted section 12 and the nasally inserted section 11 through elastic force, making the connection between the two tight. The soft characteristic can avoid damaging the surrounding tissues during the process of inserting into the hypopharynx.

[0039] In this embodiment, the sponge 6 is specifically selected as an expandable sponge. The expandable sponge has good water absorption performance and a large volume change after water absorption, which can appropriately compress the internal fistula opening. Specifically, the sponge 6 is cylindrical, with a diameter of 1.2 - 1.5 cm and a length of 3 - 4 cm. The sponge 6 with the above dimensions has a moderate volume, can be placed at the hypopharynx of the patient, and can appropriately compress the internal fistula opening after becoming larger. The sponge 6 is fixed on the drainage tube 2 by a suture. The suture can specifically adopt a non-absorbable suture. The fixed effect is good by using the suture fixation method, and the material is easy to obtain and has high cleanliness.

[0040] In this embodiment, an inflation valve 7 is provided at the end of the inflation tube 3 far from the airbag 5. The inflation valve 7 can select a common opening and closing air valve. The inflation valve 7 is used to control the on-off of the inflation tube 3, and thus control the inflation and deflation process of the airbag 5.

[0041] The outer diameter of the drainage tube 2 is 4.5 - 5.5 mm, and the outer diameter of the inflation tube 3 is 0.8 - 1.2 mm. The drainage tube 2 and the inflation tube 3 with the above dimensions can achieve effective drainage and inflation, and their diameters are relatively small, which can reduce the discomfort of the patient during the implantation process.

[0042] In the description of the present application, it should be understood that the orientation or positional relationship indicated by orientation words such as "front, back, up, down, left, right", "horizontal, vertical, level" and "top, bottom", etc. is usually based on the orientation or positional relationship shown in the drawings. It is only for the convenience of describing the present application and simplifying the description. Without contrary explanation, these orientation words do not indicate and imply that the device or element referred to must have a specific orientation or be constructed and operated in a specific orientation. Therefore, it should not be construed as a limitation on the protection scope of the present application.

[0043] For the convenience of description, spatial relative terms such as "above...", "over...", "on the upper surface of...", "above" etc. can be used here to describe the spatial positional relationship between a device or feature shown in the drawings and other devices or features. It should be understood that the spatial relative terms are intended to include different orientations in use or operation in addition to the orientation described in the drawings for the device. For example, if the device in the drawing is inverted, the device described as "above other devices or structures" or "over other devices or structures" will then be positioned as "below other devices or structures" or "under other devices or structures". Thus, the exemplary term "above..." can include both the orientations of "above..." and "below...". The device can also be positioned in other different ways (rotated 90° or in other orientations), and the corresponding explanations for the spatial relative descriptions used here will be made.

[0044] In addition, it should be noted that the use of words such as "first", "second" etc. to limit the components is only for the convenience of differentiating the corresponding components. Without additional declaration, the above words have no special meaning. Therefore, it should not be construed as a limitation on the protection scope of the present application.

[0045] For those skilled in the art, various corresponding changes and deformations can be made according to the technical solutions and concepts described above, and all such changes and deformations should fall within the protection scope of the claims of the present invention.

Claims

1. An oral continuous negative pressure drainage device for preventing and treating pharyngeal fistula, characterized in that, Comprising an insertion tube, the insertion tube includes a drainage tube and an inflation tube arranged side by side; the front section of the insertion tube is a nasal insertion section, and the rear section is a hypopharyngeal insertion section; the nasal insertion section and the hypopharyngeal insertion section are detachably connected by a connecting piece; a plurality of drainage holes are provided on the side surface of the end of the drainage tube, and an airbag is provided at the end of the inflation tube, and the airbag communicates with the inflation tube; a sponge is coated outside the drainage holes and the airbag; The connecting piece is cylindrical, and a first connection hole and a second connection hole are axially opened therein. The aperture of the first connection hole is adapted to the outer diameter of the drainage tube, and the aperture of the second connection hole is adapted to the outer diameter of the inflation tube; The first connection hole and the second connection hole are structures that communicate with each other on the side; The sponge is used to absorb liquid and expands when absorbing liquid and inflating the airbag, so as to appropriately compress the internal fistula opening and play a role in reducing the wound surface; During use, separate the three components of the nasal insertion section, the connecting piece and the hypopharyngeal insertion section. First, connect the hypopharyngeal insertion section and the connecting piece for standby. Then, insert one end of the nasal insertion section into one side of the nasal cavity. After inserting to a certain depth, use long forceps from the oral cavity to pull out the end of the nasal insertion section; then connect the end of the nasal insertion section pulled out from the oral cavity to the connecting piece, and further connect the nasal insertion section and the hypopharyngeal insertion section; make the nasal insertion section and the hypopharyngeal insertion section be tightly connected, and check the airtightness of the connection position. After determining the tight connection, insert the hypopharyngeal insertion section from the patient's oral cavity into the patient's hypopharyngeal position; during the insertion process, the top of the sponge does not exceed the dorsal surface of the tongue, and the end of the sponge abuts against the pyriform fossa or the postcricoid area; After inserting the hypopharyngeal insertion section into the hypopharynx, connect the external end of the drainage tube to a negative pressure suction device, and adjust the pressure of the negative pressure suction device to 60 kPa to generate negative pressure inside the drainage tube.

2. The oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to claim 1, characterized in that, The connecting piece is made of rubber material.

3. The oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to claim 1, wherein The sponge is an expandable sponge.

4. The transoral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to claim 3, characterized in that, The sponge is cylindrical, with a diameter of 1.2 - 1.5 cm and a length of 3 - 4 cm.

5. The oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to claim 3, characterized in that, The sponge is fixed on the drainage tube by a suture.

6. The oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to claim 1, wherein, An inflation valve is provided at the end of the inflation tube away from the airbag, and the inflation valve is used to control the on-off of the inflation tube.

7. The oral continuous negative pressure drainage pharyngeal fistula prevention and treatment device according to claim 1, wherein The outer diameter of the drainage tube is 4.5 - 5.5 mm, and the outer diameter of the inflation tube is 0.8 - 1.2 mm.

Images