CN114246649A

CN114246649A - Balloon device with sensor and method for operating and manufacturing balloon device

Info

Publication number: CN114246649A
Application number: CN202011008752.4A
Authority: CN
Inventors: 周佳
Original assignee: Zhuji Purui Youfu Medical Technology Co ltd
Current assignee: Shanghai Qiubei Medical Technology Co ltd
Priority date: 2020-09-23
Filing date: 2020-09-23
Publication date: 2022-03-29

Abstract

The invention provides a manufacturing method of a balloon device with a sensor, which comprises the following steps: (a) providing a double lumen tube; (b) embedding a plurality of sensors in a balloon; and (c) arranging the saccule at the front end of the double-cavity tube and keeping a preset distance.

Description

Balloon device with sensor and method for operating and manufacturing balloon device

Technical Field

The invention relates to the technical field of medical auxiliary instruments, in particular to a balloon device with a sensor and an operation and manufacturing method thereof.

Background

In the diagnosis and treatment of various common gynecological diseases, many symptoms require cervical dilatation, such as induced abortion, ring removal and placement, uterine curettage, obstetric labor induction, and gynecological operation including hysteroscopy. In particular, cervical uterine cavity changes caused by lesions such as adhesion or myoma often cause difficult uterine dilatation, and uterine perforation injury infection caused by violent rough uterine dilatation operation is often caused in the diagnosis and treatment process, which is a common complication of gynecological operation. In addition, bleeding and injury caused by uterus dilatation and labor induction are also common complications for puerperae. In other words, cervical injury caused by improper cervical dilatation is also an important factor for cervical adhesion, which causes difficulty in cervical dilatation. Further, adhesion refers to the occurrence of abnormal fibrous adhesion to other tissues of the body during the healing process of the body tissue of a patient due to a wound or a surgical wound. Symptoms caused by adhesions include intestinal obstruction, menstrual pain, infertility, ectopic pregnancy, abortion, and even pain in the female during sexual activity. In other words, improper cervical dilatation and cervical adhesions produce a corresponding relationship. Generally speaking, the examination steps of the prior induced labor uterus dilating instrument applied in clinic are complicated, a plurality of instruments are involved, corresponding cervical catheters and uterine catheters are not suitable for the uterine cervix condition, the pressure cannot be controlled, and risks such as liquid leakage, gas-liquid embolism, perforation damage and the like are easy to occur.

It is worth mentioning that most of the induced labor uterine dilatation balloons used clinically at present are replaced by cervical catheters or uterine cavity catheters or common Foley catheters in urology, and water and gas are introduced into the balloon through a cavity channel in the catheter to perform cervical dilatation. However, the existing uterine dilator devices have great problems: 1. the cervical uterine cavity change caused by the adhesion or the myoma and other pathological changes makes the entry of the uterine dilator very difficult, and the uterine dilator which is not suitable for the cervical orifice can not enter in many cases, thus causing the failure of the uterine dilation. 2. Under the condition of difficult uterus dilatation, the high-strength pressure expansion balloon is easy to cause the injury of the internal and external mouths of the cervix to cause cervical adhesion, and the operation of roughness and violence even can cause the tearing of the cervix. 3. The pressure position of the cervical orifice can only estimate the pressure by feeling and the balloon inflation liquid filling amount, so that the excessive inflation liquid is easy to cause damage to the uterine body of the cervical uterine cavity. In addition, the current obstetrical induced labor balloon has a lot of improvement spaces: 1. neither cervical uterine catheters nor Foley catheters which are used most clinically are specially designed and developed for induction of labor, are not in accordance with the shapes of the cervix and the lower uterine segment, are not tightly attached, and are easy to cause leakage, and the excessive pressure easily causes air embolism. 2. Because only one transfusion tube cavity is provided, the pressure in the uterine cavity and the cervix uteri cannot be monitored, a built-in sensor is not provided, the pressure is evaluated only by calculating the transfusion quantity, the operation is tedious, and the accuracy is lacked. 3. The latex catheter is soft in texture, and the expanded saccule is easy to press and block the birth canal after being placed in the uterine cavity, so that the uterine dilatation fails.

Disclosure of Invention

An advantage of the present invention is that it provides a sensor balloon apparatus and methods of operating and manufacturing the same, wherein the sensor balloon apparatus of the present invention is an easily operated, safe and effective, multi-functional and one-stop pressure detectable cervical dilation apparatus.

An advantage of the present invention is that it provides a balloon apparatus with a sensor and a method for operating and manufacturing the same, wherein the balloon apparatus is improved by using the existing operating instruments to reduce the operation of the cervix in the uterine cavity, and the balloon apparatus can be widely applied to the preparation of the cervix before gynecological operation and the induction of labor in obstetrics.

An advantage of the present invention is that it provides a balloon apparatus with a sensor and a method for operating and manufacturing the same, wherein the balloon apparatus can monitor the pressure of the cervix or the uterine cavity at any time, and monitor the progress of labor in real time, so as to reduce the occurrence of injury of the internal and external orifices of the cervix caused by over-high pressure uterine dilatation. Meanwhile, the potential risk of cervical or vaginal contamination caused by repeated entering of the traditional uterine dilator into the uterine cavity is avoided. In other words, the balloon device may achieve a desired cervical dilation width at a time.

One advantage of the present invention is that it provides a balloon apparatus with sensors and methods of operation and manufacture thereof, wherein the balloon apparatus includes uterine cavity drainage and drainage functions. In other words, the physiological saline/liquid medicine can be infused or the liquid flowing function is realized, the shape of the uterine cavity and the cervix is better fitted, and the occurrence probability of liquid leakage is reduced.

One advantage of the present invention is that a balloon apparatus with a sensor and methods for operating and manufacturing the same are provided, wherein a first channel is externally connected to a container bag for measuring the amount of accumulated blood and liquid medicine flowing out of the uterine cavity, and is also externally connected to a pressure gauge for monitoring the intrauterine pressure, thereby avoiding damage caused by over-high uterine cervix pressure.

An advantage of the present invention is that it provides a balloon apparatus with a sensor and a method of operating and manufacturing the same, wherein the first channel serves as a fluid communication and drainage path to facilitate administration of drugs and irrigation of the uterine cavity, if necessary.

One advantage of the present invention is that it provides a balloon device with a sensor and methods for operating and manufacturing the same, wherein the balloon device is simple to manufacture, easy to operate, simple and easy to learn in clinical use, convenient to sterilize, less in allergic reaction of silica gel, good in biocompatibility, and easy to popularize in a large scale.

It is an advantage of the present invention that it provides a balloon apparatus with a sensor and methods of operating and manufacturing the same, wherein a desired width is achieved in a single dilation of the cervix while simultaneously measuring the pressure of the uterine cervix. In particular, the balloon device may even be capable of direct treatment modalities such as uterine cavity administration or lavage, if desired.

Additional advantages and features of the invention will be set forth in the detailed description which follows and in part will be apparent from the description, or may be learned by practice of the invention as set forth hereinafter.

In accordance with the present invention, the foregoing and other objects and advantages are achieved in accordance with the present invention by a balloon apparatus with sensors adapted to simultaneously achieve a desired cervical dilatation and measure a uterine cavity or a cervical pressure at a time, wherein the balloon apparatus comprises:

a dual lumen tube;

the saccule is arranged in the double-cavity tube and keeps a preset distance with the front end of the double-cavity tube; and

a plurality of sensors respectively embedded in the balloons.

According to an embodiment of the invention, the double lumen tube comprises a main cannula, a first channel and a second channel, wherein the first channel and the second channel are integrally embedded in the main cannula, wherein the main cannula is embodied as a hollow elongated tube having a rounded tip, the first channel is adapted to communicate and/or drain fluid to the uterine cavity, and the second channel is adapted to fill the balloon with a fluid.

According to one embodiment of the invention, the first channel comprises a first connection end for connection to a container bag, and the second channel comprises a second connection end for connection to a fluid inlet device, the second connection end of which protrudes from the main sleeve.

According to one embodiment of the invention, the first channel and the second channel are concentric annular channels.

According to one embodiment of the invention, the primary sleeve has a central lumen that is the first passageway, and the second passageway surrounds the first passageway.

According to an embodiment of the invention, the main sleeve has a central cavity and an annular wall surrounding the central cavity, wherein the first channel has at least one liquid passing tube and at least one liquid discharging tube respectively located at the annular wall for delivering the liquid medicine or discharging the liquid respectively.

According to one embodiment of the invention, a first outlet of the first channel is located between the tip and the balloon.

According to an embodiment of the invention, said preset distance is implemented as 2-3 cm.

According to one embodiment of the invention, the main sleeve has a metering scale.

According to one embodiment of the invention, a pressure gauge is connected to the first channel to monitor the pressure in the uterine cavity.

According to one embodiment of the invention, the plurality of sensors is implemented as six pressure sensors embedded around, on top of and at the bottom of the balloon, respectively, to monitor uterine/cervical pressure.

According to one embodiment of the invention, the balloon is implemented as an elliptical inflatable silicone balloon.

According to an embodiment of the invention, the double lumen tube is implemented as a high durometer silicone tube.

In accordance with the present invention, the foregoing and other objects and advantages are realized in accordance with the method of operating a balloon apparatus having a sensor of the present invention, comprising the steps of:

(A) inserting a double-cavity tube to detect the position and depth of a uterine cavity;

(B) adjusting the double-cavity tube to enable a balloon to be positioned at a cervix;

(C) injecting a fluid into the balloon to dilate the cervix to a desired width; and

(D) at least one pressure sensing signal is received.

An operating method according to the invention, further comprising the steps of:

(E) irrigating or administering the drug to the uterine cavity via the dual lumen tube; and

(F) and (6) metering the capacity.

According to one method of operation of the present invention, according to step (a), wherein the double lumen tube comprises a main cannula, a first channel and a second channel, wherein the first channel and the second channel are integrally embedded in the main cannula, wherein the main cannula is implemented as a hollow elongated tube having a rounded tip.

According to an operation method of the invention, according to the step (B), the double-cavity tube is slightly withdrawn to the scale of 2-3cm after the uterus probing depth, and the balloon is ensured to be positioned in the cervical canal.

According to one method of operation of the present invention, according to step (C), a gentle bolus of the fluid is administered to the second channel via a fluid input device to inflate the balloon, thereby ensuring that the balloon dilates the cervix to a desired width.

According to one method of operation of the present invention, according to step (D), cervical pressure is monitored via a plurality of sensors embedded in the balloon.

According to one method of operation of the present invention, in step (F), during the draining of the uterine cavity, a first inlet of a first channel is connected to a container bag having a graduated scale for accurately measuring the volume of the liquid discharged.

According to the operation method of the invention, according to the step (F), when the uterine cavity is filled with liquid, a first inlet of a first channel is connected with a container bag which is provided with a scale mark so as to measure the volume of liquid medicine or normal saline which is input into the uterine cavity.

According to the present invention, the foregoing and other objects and advantages are achieved in a method of manufacturing a balloon apparatus with a sensor, comprising the steps of:

(a) providing a double lumen tube;

(b) embedding a plurality of sensors in a balloon; and

(c) and arranging the saccule at the front end of the double-cavity tube and keeping a preset distance.

According to one manufacturing method of the present invention, in step (a), the double lumen tube includes a main cannula, a first passage and a second passage, wherein the first passage and the second passage are integrally embedded in the main cannula, wherein the main cannula is implemented as a hollow elongated tube having a circular arc-shaped tip end.

According to one method of manufacturing of the present invention, the first channel includes a first connection end for connecting to a container bag, and the second channel includes a second connection end for connecting to a fluid input device.

According to one manufacturing method of the present invention, in step (b), six of the sensors are embedded around, on top of and at the bottom of the balloon to monitor uterine/cervical pressure.

According to one method of manufacture of the present invention, in step (c), wherein a second channel of the dual lumen tube connects the balloon and a fluid input device, the balloon is inflated by gradually infusing the fluid into the second channel via the fluid input device.

Further objects and advantages of the invention will be fully apparent from the ensuing description and drawings.

These and other objects, features and advantages of the present invention will become more fully apparent from the following detailed description, the accompanying drawings and the claims.

Drawings

FIG. 1 is a schematic view of a balloon apparatus with sensors according to a first preferred embodiment of the present invention.

Fig. 2 is a cross-sectional view a-a according to fig. 1.

Fig. 3 is a cross-sectional view B-B according to fig. 1.

Fig. 4A to 4C are schematic views of a balloon device with a sensor and an external device according to a first preferred embodiment of the present invention.

Fig. 5 is a schematic view of a balloon apparatus with sensors according to a first variant of the first preferred embodiment of the invention.

Fig. 6 is a schematic view of a balloon apparatus with sensors according to a second variant embodiment of the first preferred embodiment of the invention.

Fig. 7 is a schematic view of a balloon apparatus with sensors according to a third variant embodiment of the first preferred embodiment of the invention.

Fig. 8 is a schematic view of a balloon apparatus with sensors according to a fourth variant embodiment of the first preferred embodiment of the invention.

Detailed Description

The following description is presented to disclose the invention so as to enable any person skilled in the art to practice the invention. The preferred embodiments in the following description are given by way of example only, and other obvious variations will occur to those skilled in the art. The basic principles of the invention, as defined in the following description, may be applied to other embodiments, variations, modifications, equivalents, and other technical solutions without departing from the spirit and scope of the invention.

It will be understood by those skilled in the art that in the present disclosure, the terms "longitudinal," "lateral," "upper," "lower," "front," "rear," "left," "right," "vertical," "horizontal," "top," "bottom," "inner," "outer," and the like are used in an orientation or positional relationship indicated in the drawings for ease of description and simplicity of description, and do not indicate or imply that the referenced devices or components must be constructed and operated in a particular orientation and thus are not to be considered limiting.

It is to be understood that the terms "a" and "an" are to be interpreted as meaning "at least one" or "one or more," i.e., that a single element may be present in a single embodiment, while in other embodiments the element may be present in a plurality, and the terms "a" and "an" are not to be interpreted as limiting the number.

Referring to fig. 1 to 4B, there are shown a balloon apparatus with a sensor and a method for operating and manufacturing the same according to a first preferred embodiment of the present invention, wherein the balloon apparatus with a sensor can reach a desired width at a time and simultaneously measure a uterine cervix pressure during a cervical dilatation procedure. In particular, the balloon device with sensor 1 may also have the efficacy of supplying drugs and draining the hematocele or effusion in the uterine cavity.

The balloon apparatus with sensors 1 includes a dual lumen tube 10, a balloon 20 and a plurality of sensors 30. The balloon 20 is disposed in the double lumen tube 10 and maintains a predetermined distance from the front end of the double lumen tube 10. In the present embodiment, the preset distance is implemented as 2-3cm, but this is not a limitation of the present invention. In other words, the predetermined distance can be adjusted according to the structural design. A plurality of sensors 30 are respectively embedded in the balloon 30, wherein the pressure of a cervix or a uterine cavity can be monitored at any time by the sensors 30, so as to integrate the existing clinical instruments and methods to the maximum extent.

Further, the balloon device 1 with sensor is passed through the balloon 20 which is slowly inflated so that it obturates and dilates the cervix, the pressure of which and the uterine cavity are monitored by the sensor 30 throughout the inflation process. In the process of expanding the saccule 20, the inner and outer mouths of the cervix are uniformly stressed, and the expanded saccule 20 is positioned in the cervix and is fitted with the shape of the cervix, so that the cervix or the uterine cavity is prevented from being damaged by overhigh pressure. In other words, the cervical process is dilated with a uniform balance of force.

The dual lumen tube 10 includes a main cannula 11, a first channel 12 and a second channel 13. The first channel 12 is formed in the main sleeve 11 for the passage and/or drainage of fluid to the uterine cavity. The second channel 13 is partially disposed in the main sleeve 11 for filling the balloon 20 with a fluid. It is worth mentioning that the first passage 12 and the second passage 13 are integrally formed in the main sleeve 11. In other words, the first passage 12 and the second passage 12 are embedded in the main casing 11, respectively. In addition, the main tube 11 has a measuring scale 111 for clearly knowing the relative position of the dual lumen tube 10 and the cervix.

Further, the first channel 12 has a first inlet 121, a first outlet 122 and a first hollow tube 123. The first hollow tube 123 is located between the first inlet 121 and the first outlet 122. It should be noted that if a lavage or administration is required in the uterine cavity, a medical solution or a physiological saline is introduced into the first hollow tube 123 from the first inlet 121, and is delivered through the first hollow tube 123, and then the medical solution or the physiological saline is delivered to the uterine cavity from the first outlet 122. That is, the first outlet 122 is introduced into or near the uterine cavity, so that the medical solution or the saline is delivered to the uterine cavity through the first outlet 122. It will be appreciated that when a fluid, such as a blood or fluid accumulation, is to be removed from the uterine cavity, the fluid enters the first hollow tube 123 through the first outlet 122, is transported through the first hollow tube 123, and is finally removed through the first inlet 121. In particular, the first inlet 121 is connected to a container bag 40 having a graduated scale 41 for accurately metering the volume of liquid discharged. In particular, the container bag 40 may be embodied as a urine collection bag, but is not a limitation of the present invention. In particular, the container bag 40 may also be implemented as a pouch or a physiological saline bag. When the container bag 40 is implemented as the medicine bag or the saline bag, the scale marks 41 on the container bag 40 are used to measure the volume of the medicine liquid or the saline inputted into the uterine cavity. In addition, the second channel 13 has a fluid outlet 131, a fluid inlet 132 and a fluid conduit 133. The fluid line 133 is located between the fluid outlet 131 and the fluid inlet 132. The fluid outlet 131 is connected to the balloon 20, wherein a fluid enters the fluid conduit 133 from the fluid inlet 132, and is delivered to the balloon 20 through the fluid conduit 133 and then through the fluid outlet 131. Further, the fluid can uniformly expand the balloon 20 to a desired degree, and the inflated balloon 20 can completely fill the cervix to closely fit the inner and outer cervix or the lower uterine segment. In addition, the first channel 12 further comprises a first connecting end 124, wherein the first inlet 121 is located at the first connecting end 124 and is adapted to be connected to the container bag 40. The second channel 13 also includes a second connection end 134 for connecting to a fluid input device 50. It will be appreciated that the fluid inlet 132 is located at the second connection end 134. In particular, the second connection end 134 protrudes from the main sleeve 11 to be adapted to be connected to the fluid input device 50.

It is worth mentioning that the double lumen tube 10 is implemented as a high durometer silicone tube. The balloon 20 is implemented as a high strength silicone balloon. Further, the balloon 20 is embodied as an oval inflatable balloon. A plurality of the sensors 30 are implemented as six pressure sensors embedded around, on top of, and at the bottom of the balloon 20, respectively, to monitor uterine/cervical pressure. In addition, a pressure gauge 60 can be connected to the first channel 12 to monitor the pressure in the uterine cavity, so as to avoid damage caused by over-high cervical pressure in the uterine cavity.

In this embodiment of the present invention, the main sleeve 11 is formed as a hollow elongated tube, and the top end 113 is formed as a circular arc, so that the main sleeve 11 has a slight elasticity, and the damage caused by using the present invention can be reduced. In addition, the main sleeve 11 has a central cavity 111 and an annular wall 112. The annular wall 112 is shaped circumferentially and forms a hollow central cavity 111 in the middle. The balloon 20 is disposed on the main sleeve 11 and keeps the preset distance from the top end 113 of the main sleeve 11. In addition, the first channel 12 is located in the annular wall 112. That is, the annular wall 112 has a predetermined thickness, and the first channel 12 is circumferentially formed on the annular wall 112. And, through the first outlet 122 of the first passage 12 between the tip 113 and the balloon 20, to output the medical fluid from the first outlet 122 or to discharge the fluid in the uterine cavity from the first outlet 122. In addition, the second channel 13 is located on one side of the annular wall 112. That is, the first passage 12 is an annular passage, and the second passage 13 is a hollow passage. It is worth mentioning that the main sleeve 11 has an inner wall 114, an outer wall 115 and an intermediate wall 116. The first channel 12 is located between the inner wall 114 and the outer wall 115. The intermediate wall 116 is disposed between the first channel 12 and the second channel 13. The second channel 13 is located between the outer wall 115 and the intermediate wall 116.

Further, as shown in fig. 5, a first modified embodiment is provided in which the first passage 12 and the second passage 13 are coaxially provided. In other words, the first passage 12 and the second passage 13 are circumferentially formed in the annular wall 112, respectively. In other words, the first channel 12 and the second channel 13 are both annular channels.

In addition, as shown in fig. 6, a second variant embodiment is shown, in which the central cavity 111 of the main sleeve 11 serves as the first passage 12. Also, the first passage 12 includes a plurality of through holes 125 that communicate the first passage 12 with the outer wall 115. In particular, the second channel 13 is formed circumferentially on the annular wall 112. In other words, the second channel 13 is an annular channel.

In addition, as shown in fig. 7, a third variant embodiment is shown, in which the central cavity 111 of the main sleeve 11 serves as the first passage 12. Also, the first passage 12 includes a plurality of through holes 125 that communicate the first passage 12 with the outer wall 115. In particular, the second channel 13 is a hollow channel. It should be mentioned that the main sleeve 11 has an inner wall 114, an outer wall 115 and an intermediate wall 116. The first channel 12 is formed by the inner wall 114. The intermediate wall 116 is disposed between the first channel 12 and the second channel 13. The second channel 13 is located between the outer wall 115 and the intermediate wall 116. In particular, the second connection end 134 protrudes from the main sleeve 11 to be adapted to be connected to the fluid input device 50.

In addition, as shown in fig. 8, a fourth variant embodiment is shown, in which the first channel 12 has at least one liquid-passing tube 126 and at least one liquid-discharging tube 127 respectively located on the annular wall 112 for respectively delivering the liquid medicine or discharging the liquid.

In addition, the invention also provides an operation method of the balloon device with the sensor, which comprises the following steps:

(A) inserting a double lumen tube 10 to detect a position and depth of a uterine cavity;

(B) adjusting the double lumen tube 10 to position a balloon 20 at a cervix;

(C) injecting a fluid into the balloon 20 to dilate the cervix to a desired width; and

(D) at least one pressure sensing signal is received.

The above operation method, further comprising the step (E):

(E) the uterine cavity is irrigated or dosed via the dual lumen tube 10.

The above operation method, further comprising the step (F):

(F) and (6) metering the capacity.

According to step (a), wherein the dual lumen tube comprises a main cannula 11, a first channel 12 and a second channel 13, wherein the first channel and 11 the second channel 13 are integrally embedded in the main cannula 11. The main casing 11 is implemented as a hollow elongated tube, the top end of which is circular arc-shaped.

According to the step (B), the double-cavity tube 10 is slightly withdrawn to the position with the scale of 2-3cm after the uterus is explored deeply, and the saccule is ensured to be positioned in the cervical canal.

According to step (C), the balloon 20 is filled with a fluid via the second channel 13 of the dual lumen tube. Further, a bolus of the fluid, which may be implemented as a physiological saline, is administered slowly to the second channel 13 via a fluid input device 50, causing inflation of the balloon 20, thereby ensuring that the balloon 20 expands the cervical region to the desired width.

According to step (D), cervical pressure is monitored via a plurality of sensors embedded in the balloon 20. A plurality of the sensors are implemented as six pressure sensors embedded around, on top of, and at the bottom of the balloon to monitor uterine/cervical pressure, respectively. In addition, a pressure gauge is externally connected to the first channel 12 to monitor the pressure in the uterine cavity.

According to step (E), the uterine cavity is drained and/or drained via the first channel 12.

According to step (F), during the uterine drainage, a first inlet 121 of the first channel 12 is connected to a container bag 40 having a scale mark 41 for precisely measuring the volume of the liquid to be drained.

According to the step (F), when the uterine cavity is filled with liquid, a first inlet 121 of the first channel 12 is connected to a container bag 40 having a scale mark 41 for measuring the volume of the liquid medicine or the physiological saline inputted into the uterine cavity.

In addition, the invention also provides a manufacturing method of the balloon device with the sensor, which comprises the following steps:

(a) providing a dual lumen tube 10;

(b) embedding a plurality of sensors 30 in a balloon 20; and

(c) the balloon 20 is disposed at the front end of the double lumen tube 10 and is maintained at a predetermined distance.

In step (a), the double-lumen tube comprises a main sleeve 11, a first channel 12 and a second channel 13, wherein the first channel and the

second channel

11 and 13 are integrally embedded in the main sleeve 11. The main casing 11 is implemented as a hollow elongated tube, the top end of which is circular arc-shaped.

In step (b), six of the sensors 30 are embedded around, on top of, and at the bottom of the balloon 20 to monitor uterine/cervical pressure.

In step (c), wherein the second channel 13 of the dual lumen tube 10 connects the balloon 20 and a fluid input device 50, a bolus of the fluid, which may be embodied as a physiological saline, is gently injected into the second channel 13 via the fluid input device 50, causing inflation of the balloon 20, thereby ensuring that the balloon 20 dilates the cervix to a desired width.

It will be appreciated by persons skilled in the art that the embodiments of the invention described above and shown in the drawings are given by way of example only and are not limiting of the invention.

The objects of the invention have been fully and effectively accomplished. The functional and structural principles of the present invention have been shown and described in the embodiments, and any modifications or changes may be made to the embodiments of the present invention without departing from the principles.

Claims

1. A balloon apparatus having a sensor for simultaneously achieving a desired cervical dilation and measuring a uterine cavity or a cervical pressure, comprising:

a dual lumen tube;

a plurality of sensors respectively embedded in the balloons.

2. The balloon apparatus with sensor according to claim 1, wherein the double lumen tube comprises a main cannula, a first channel and a second channel, wherein the first channel and the second channel are integrally embedded in the main cannula, wherein the main cannula is implemented as a hollow elongated tube having a rounded tip, the first channel is used for feeding and/or discharging fluid to the uterine cavity, and the second channel is used for filling a fluid to the balloon.

3. The balloon apparatus with sensor of claim 2, wherein the first channel includes a first connection end to connect to a reservoir bag, the second channel includes a second connection end to connect to a fluid input device, the second connection end of which protrudes from the primary sleeve.

4. The balloon device with a sensor of claim 2, wherein the first channel and the second channel are concentric annular channels.

5. The balloon apparatus with a sensor according to claim 2, wherein the main sleeve has a central lumen that is the first channel, the second channel surrounding the first channel.

6. The balloon apparatus with sensor according to claim 2, wherein the main sleeve has a central lumen and an annular wall surrounding the central lumen, wherein the first channel has at least one liquid passing tube and at least one liquid discharging tube respectively located at the annular wall for delivering liquid medicine or performing liquid discharging respectively.

7. The balloon apparatus with sensor of any of claims 2-6, wherein a first outlet of the first channel is located between the tip and the balloon.

8. The balloon apparatus with a sensor according to any one of claims 1-6, wherein the preset distance is implemented as 2-3 centimeters.

9. The balloon apparatus with a sensor according to claim 8, wherein the main sleeve has a gauge scale.

10. The balloon apparatus with sensor according to claim 9, wherein a pressure gauge is connected to the first channel to monitor the pressure in the uterine cavity.

11. The balloon apparatus with sensors of claim 10, wherein a plurality of the sensors are implemented as six pressure sensors embedded around, on top of and at the bottom of the balloon, respectively, to monitor uterine/cervical pressure.

12. The balloon device with sensor of claim 10, wherein the balloon implements an elliptical inflatable silicone balloon.

13. The balloon device with a sensor according to claim 10, wherein the dual lumen tube is implemented as a high durometer silicone tube.

14. A method of operating a balloon device having a sensor, comprising the steps of:

(D) at least one pressure sensing signal is received.

15. The method of operation of claim 14, further comprising the steps of:

(F) and (6) metering the capacity.

16. The method according to claim 14, wherein the double lumen tube comprises a main cannula, a first channel and a second channel, wherein the first channel and the second channel are integrally embedded in the main cannula, wherein the main cannula is implemented as a hollow elongated tube having a rounded tip.

17. The method of claim 14, wherein in step (B), the double lumen tube is withdrawn a little bit after probing the uterus to a scale of 2-3cm to ensure that the balloon is located in the cervical canal.

18. The method of claim 14, wherein according to step (C), a gentle bolus of the fluid into the second channel via a fluid input device inflates the balloon, thereby ensuring that the balloon dilates the cervix to a desired width.

19. The method of operation of claim 14, according to step (D), monitoring cervical pressure via a plurality of sensors embedded in the balloon.

20. The method of claim 15, wherein during the draining of the uterine cavity in step (F), a first inlet of a first channel is connected to a container bag having a scale mark for accurately measuring the volume of the liquid discharged.

21. The method of claim 15, wherein during step (F), the uterine cavity is accessed, wherein a first inlet of a first channel is connected to a reservoir bag having a graduated scale for metering the volume of medical fluid or saline introduced into the uterine cavity.

22. A method of manufacturing a balloon apparatus having a sensor, comprising the steps of:

(a) providing a double lumen tube;

(b) embedding a plurality of sensors in a balloon; and

23. The method of manufacturing according to claim 22, wherein in step (a), the double lumen tube comprises a main cannula, a first channel and a second channel, wherein the first channel and the second channel are integrally embedded in the main cannula, wherein the main cannula is implemented as a hollow elongated tube having a rounded tip.

24. The method of manufacturing as defined in claim 23, wherein the first channel includes a first connection end to connect to a container bag and the second channel includes a second connection end to connect to a fluid input device.

25. The method of manufacturing of claim 22, in step (b), embedding six of the sensors around, on top of, and at the bottom of the balloon to monitor uterine/cervical pressure.

26. The method of manufacturing according to claim 22, wherein in step (c) a second channel of the dual lumen tube connects the balloon and a fluid input device via which a gentle bolus of the fluid is administered to the second channel to inflate the balloon.