CN113041483A

CN113041483A - Balloon catheter for dilating eustachian tube and variable-angle shaping plate

Info

Publication number: CN113041483A
Application number: CN202110260403.XA
Authority: CN
Inventors: 杨海; 李建军
Original assignee: Suzhou Lechang Medical Instrument Co ltd
Current assignee: Lechang medical instrument (Shanghai) Co., Ltd
Priority date: 2021-03-10
Filing date: 2021-03-10
Publication date: 2021-06-29

Abstract

The invention relates to a balloon catheter for dilating a eustachian tube, which is characterized by comprising a catheter main body and a bendable inner lining core wire. According to another technical scheme, the invention provides a variable-angle shaping plate for shaping the distal end of the balloon catheter for dilating the eustachian tube. The invention can meet the clinical requirements of different anatomical structures, does not need a guide catheter and can be directly and accurately implanted into a diseased part. In the operation, the shaping of the far-end angle is carried out according to the actual anatomical structure of the eustachian tube to be treated, so that one patient can be operated, and the treatment of different eustachian tubes can be completed by only one catheter. Not only can reduce the operation cost of the patient, but also can reduce the operation time and reduce the pain of the patient.

Description

Balloon catheter for dilating eustachian tube and variable-angle shaping plate

Technical Field

The invention relates to a balloon catheter capable of being shaped at different distal end bending angles, and belongs to the technical field of medical instruments.

Background

The eustachian tube is a pipeline for communicating the tympanic cavity and the nasopharyngeal cavity and is an important component of the middle ear sound transmission mechanism. It has multiple physiological functions including middle ear pressure balancing, ventilation enhancing, middle ear secretion clearing, sound proofing, and retrograde infection preventing.

The anatomical structure of the eustachian tube is from the anterior wall of the tympanic cavity forward, inward, downward to the nasopharynx, and is in an S-shaped form. The eustachian tube of the adult in China is about 31-38mm long, forms an angle of 40 degrees with the horizontal position and an angle of 45 degrees with the sagittal position, and is shorter and flatter than that of a male. The child eustachian tube is flatter than an adult and forms an angle of about 10 degrees with the horizontal plane. The eustachian tube is divided into a bone part and a cartilage part which are both similar to a cone. The junction of the two is an isthmus with a diameter of about 1.5 mm. The two portions of the tube typically form an angle of about 145 ° at the junction. Anatomical variation in this area, such as "bifurcation junction" where the junction is not on one axis, excessive narrowing of the isthmus's internal diameter or neoplastic mucosal flap, can cause eustachian tube dysfunction. The eustachian tube fibrocartilaginous part is a complex organ composed of a mucous membrane, cartilage, surrounding soft tissues, peritubular muscles (tensor palatine, levator palatine, eustachian tube pharyngeal muscle, tensor tympanic membrane), and a bony scaffold.

The eustachian tube dysfunction is symptoms and physical signs caused by abnormal middle ear pressure regulation function and can be divided into eustachian tube expansion dysfunction, abnormal opening of the eustachian tube and air pressure type eustachian tube dysfunction, and the adult incidence rate is 1-5%. Dilation dysfunction is the most common type of eustachian tube dysfunction in the clinic, and a common cause is inflammation of mucous membranes at the cartilaginous part of the eustachian tube. The research finds that 83% of patients have edema of mucous membrane of eustachian tube and pharyngeal mouth, and 74% of patients have descending motion of anterior lateral wall of cartilaginous part due to inflammation. Throat reflux, smoking, systemic mucosal lesions of the whole body and the like can cause inflammation of the mucosa at the cartilage part.

Drug therapy (nasal hormones, decongestants and the like) and technologies such as tympanostomy tube placement and eustachian tube insufflation are continuously applied to treatment of the dysfunction of the tympanostomy tube, but the treatment effect of the dysfunction of the eustachian tube is still not ideal due to the special anatomical position and the complex pathophysiological mechanism of the eustachian tube, and clinicians are unburdened with the patients. Until 2008, the use of eustachian tube balloon dilation for the treatment of obstructive eustachian tube dysfunction was first reported by Sudhoff et al and subsequently, through extensive clinical practice verification, the approach was gradually approved by numerous otologists.

Eustachian tube saccule dilation is characterized in that under the reinforcement of general anesthesia or epianesthesia, an intranasal endoscope is used as image reference, according to the anatomical structure of the eustachian tube of a patient, guide catheters with the bending angles of the far ends of 30/45/60/70 degrees are respectively selected, the guide catheters are implanted through the nasal cavities, the far ends of the guide catheters are connected to the pharyngeal opening of the eustachian tube, after the guide catheters are in place, the saccule catheters are implanted into the cartilage part of the eustachian tube through the guide catheters, the saccule is pressurized and dilated by using a filling device, when the rated pressure is reached in the saccule, the pressure is maintained for 2 minutes, then the liquid in the saccule is decompressed and emptied, the saccule catheter is taken out. The main mechanisms of the device mainly comprise two mechanisms, namely, the device expands the cartilaginous part of the eustachian tube; the second is the histopathological changes that cause the mucosa within the eustachian tube.

Due to differences in eustachian tube anatomy, at most 2 different bend angle guiding catheters need to be replaced and used for the same procedure. For the smooth delivery of the balloon catheter to the lesion site during the treatment of the eustachian tube on the left side, the design angle of the distal end of the guide catheter is 45 degrees; when the right eustachian tube is used for treatment, the balloon catheter is smoothly conveyed to reach a lesion part, and the design angle of the far end of the guide catheter is 70 degrees. This not only significantly increases the cost of the procedure, but also results in increased procedure time and increased patient pain.

The products for eustachian tube balloon molding at present on the market are all through designing the guide catheter of multiple different angles, namely the guide catheter all has fixed camber, use with corresponding sacculus pipe cooperation, for example, the guide catheter has four kinds of different bending angles of 30 degrees, 45 degrees, 60 degrees and 70 degrees, when a patient needs to treat left and right eustachian tubes simultaneously, may need to change 2 kinds of different guide catheters in the operation process, in addition because of patient's individual difference, need pass through the guide catheter of different bending angles for subsequent use, this not only can lead to the operation time extension, still can increase the operation expense.

For example, patent CN104220014 discloses a system and method for eustachian tube dilation, the device comprising a guide catheter and a balloon dilation catheter. The guiding catheter has a bending angle of 45-65 degrees, the balloon dilatation catheter can be slidably coupled with the guiding catheter through the guiding catheter lumen to complete delivery and positioning of the balloon catheter, and the balloon dilatation catheter has a stopper to prevent injury to the middle ear caused by crossing the isthmus when the catheter is positioned. Although the problem of delivery positioning can be partially solved, it is still time consuming and uncomfortable for the patient to replace the guide catheter during the operation, and it is costly to have two guide catheters.

Disclosure of Invention

The purpose of the invention is: the utility model provides a sacculus pipe that distal end is mouldable, can carry out the regulation of pipe distal end camber according to clinical demand in the art, solve the problem of pinpointing simultaneously through the design of inside lining core silk distal end structure. Not only reduces the operation risk, but also reduces the operation cost.

In order to achieve the above object, one aspect of the present invention provides a balloon catheter for dilating eustachian tubes, wherein when the balloon catheter is used, the end away from the operator is defined as the distal end, and the end close to the operator is defined as the proximal end, and the balloon catheter comprises a catheter main body, a bendable inner core wire and a connecting piece for connecting an external filling device; the catheter main body is a double-cavity structure with an inner cavity and an outer cavity; the outer cavity of the catheter main body is a liquid filling cavity which is communicated with the saccule positioned at the far end of the catheter main body; the outer cavity of the catheter main body extends into the balloon, the distal end of the outer cavity is in sealing fit with the balloon to prevent liquid filled in the balloon from overflowing through the distal end of the balloon catheter, and the proximal end of the outer cavity is communicated with a lateral branch of a connecting piece arranged at the proximal end of the catheter main body and used for conveying filling liquid; the inner cavity of the catheter main body is a lining core wire cavity, the far end of the lining core wire is of a spherical structure, and the lining core wire is positioned in the inner cavity except the spherical structure; the proximal end of the lumen is located within the connector.

Preferably, the inner lumen of the catheter body is arranged coaxially with the outer lumen of the catheter body.

Preferably, the catheter main body comprises an outer tube and an inner tube arranged in the outer tube, a gap between the outer tube and the inner tube is the outer cavity, and an inner cavity of the inner tube is the inner cavity.

Preferably, the distal end of the balloon is provided with a tip, and the distal end of the inner tube is positioned in the tip; the inner lining core wire penetrates through the inner pipe from the tip end to the inside of the connecting piece at the near end.

Preferably, the proximal end and the distal end of the balloon are of a first truncated cone-shaped structure, the first truncated cone-shaped structure at the distal end of the balloon is used for being connected with the tip, the first truncated cone-shaped structure at the proximal end of the balloon is used for being connected with the distal end of the outer tube, and the middle of the balloon is of a cylindrical structure for expanding lesion tissues.

Preferably, the middle part of the balloon is a second truncated cone-shaped structure, the diameter range of the far end of the second truncated cone-shaped structure is phi 2.5-4.0 mm, the diameter range of the near end of the second truncated cone-shaped structure is phi 2.75-4.5 mm, and the length of the second truncated cone-shaped structure is 10-25 mm.

Preferably, the spherical structure at the distal end of the inner lining core wire is a sphere or an ellipsoid.

Preferably, the inner core wire has a spring section located at a distal end of the inner core wire and connected to the ball structure.

Preferably, the length of the spring section is 0-80mm, more preferably 20-70mm, or more preferably 35-60 mm.

The invention further provides a variable-angle shaping plate for shaping the far end of the balloon catheter for expanding the eustachian tube, which is characterized by comprising a shaping plate body, wherein a clamping groove for clamping the inner lining core wire is formed in the shaping plate body, an arc-shaped bend angle is formed in the end part of the clamping groove, and the far end of the inner lining core wire clamped in the clamping groove is bent to an angle equivalent to the arc-shaped bend angle by using the arc-shaped bend angle.

The balloon catheter provided by the invention has the characteristic of shapeable distal end angle, can meet the clinical requirements of different anatomical structures, does not need a guide catheter, and can be directly and accurately implanted into a diseased part. In the operation, the shaping of the far-end angle is carried out according to the actual anatomical structure of the eustachian tube to be treated, so that one patient can be operated, and the treatment of different eustachian tubes can be completed by only one catheter. Not only can reduce the operation cost of the patient, but also can reduce the operation time and reduce the pain of the patient.

Specifically, compared with the prior art, the invention has the following beneficial effects:

1) by shaping the core wire in the balloon catheter, the distal end can be bent into different angles, so that the problems that the guide catheter needs to be used and replaced for multiple times in the operation are solved, the cost is reduced, and the operation time is shortened;

2) the structural design of the far end of the core wire inside the balloon catheter reduces the risk that the catheter crosses the isthmus of the eustachian tube to expand the bone of the tube to cause middle ear injury;

3) the balloon adopts a conical design, has small far end and large near section, is more similar to the anatomical structure of the eustachian tube, and has small injury and more accurate expansion.

Drawings

FIG. 1 is a front view of a balloon catheter for dilating a eustachian tube;

FIG. 2 is a front cross-sectional view of a balloon catheter for dilating a eustachian tube;

FIG. 3 is a front view of a shaping plate for shaping an inner core wire;

FIG. 4 is a schematic view of an inner core wire shaped at 45 degrees;

fig. 5 is a schematic view of an inner lining core wire containing a spring structure.

Detailed Description

The invention will be further illustrated with reference to the following specific examples. It should be understood that these examples are for illustrative purposes only and are not intended to limit the scope of the present invention. Further, it should be understood that various changes or modifications of the present invention may be made by those skilled in the art after reading the teaching of the present invention, and such equivalents may fall within the scope of the present invention as defined in the appended claims.

In the following embodiments, the end of the instrument distal to the surgeon is defined as the distal end, and the end proximal to the surgeon is defined as the proximal end.

Example 1

A distal shapeable balloon catheter for dilating eustachian tubes as shown in fig. 1 and 2 consists of an inner lining core wire 1, a tip 2, a balloon 3, an outer tube 4, an inner tube 5 and a Y-shaped connecting piece 6. The outer tube 4 has an outer diameter of 2.1mm, is of a single-cavity structure, has a central cavity with a diameter of 1.8mm, and is internally provided with an inner tube 5. The outer tube 4 and the inner tube 5 form a coaxial double-cavity structure, and a liquid through cavity is arranged between the outer tube 4 and the inner tube 5 and used for conveying liquid for expanding the saccule. The inner cavity of the inner tube 5 is a wire lining cavity with the diameter of 0.8 mm. The inner liner core wire 1 is a linear wire made of 304 stainless steel. The inner liner core wire 1 has an overall length of 165mm, and its distal end has an ellipsoidal shape having a minor axis of 2.0mm and a major axis of 3.5 mm. Two branches of the Y-shaped connecting piece 6 are standard Ruhr connectors so as to be convenient for connecting the perfusion pressurizing device. The tip 2 is polyurethane with a shore hardness of 90A. The structure of the sacculus 3 is a circular truncated cone at two ends and a middle cylindrical structure, the sacculus 3 is made of nylon 12 and has a hardness of Shore D74 degrees, and the length of the sacculus 3 is 20 mm.

Before operation, the bending angle of the catheter required for eustachian tube expansion is determined through a nasal endoscope, such as 45 degrees on the left side and 60 degrees on the right side. The inner core wire 1 is first loaded into the shaping plate 7, the distal end thereof is shaped to 45 degrees along the angle shown in fig. 3, and then the inner core wire 1 is reloaded into the balloon catheter. In operation, under the guidance of an image of a nasal endoscope, the balloon catheter provided by the invention is sent to the pharyngeal orifice of the eustachian tube on the left side, and the balloon part is sent into the eustachian tube until obvious resistance is met in the conveying process, which indicates that the ellipsoidal head of the lining core wire 1 reaches the isthmus part of the eustachian tube, the conveying is stopped, and the filling device is connected to complete the expansion of the eustachian tube on the left side.

After the balloon catheter is taken out of the body, the inner lining core wire 1 is reloaded into the shaping plate, the distal end of the inner lining core wire 1 is shaped into 60 degrees along the angle shown in fig. 3 and 4, and the inner lining core wire 1 is reloaded into the balloon catheter. Under the image guidance of a nasal endoscope, the balloon catheter is sent to the pharyngeal ostium of the eustachian tube on the right side, the balloon part is sent into the eustachian tube on the right side until the balloon part meets obvious resistance in the conveying process, the ellipsoidal head of the lining core wire 1 is shown to reach the isthmus part of the eustachian tube, the conveying is stopped, the filling device is connected, and the expansion of the eustachian tube on the right side is completed.

Example 2

A distal shapeable balloon catheter for dilating eustachian tubes as shown in fig. 1 and 2 consists of an inner lining core wire 1, a tip 2, a balloon 3, an outer tube 4, an inner tube 5 and a Y-shaped connecting piece 6. The balloon 3 is of a conical structure, the diameter of the far end is 2.75mm, the diameter of the near end is 3.0mm, and the length is 20 mm. The distal end of the inner core wire 1 is ellipsoidal and contains a 55mm spring segment 1-1, as shown in FIG. 5, and the rest of the catheter is the same as in example 1.

Before operation, the bending angle of the catheter required for eustachian tube expansion is determined through a nasal endoscope, such as 30 degrees on the left side and 70 degrees on the right side. The inner core wire 1 is first loaded into the shaping plate 7, the distal end thereof is shaped to 30 degrees along the angle shown in fig. 3, and the inner core wire 1 is reloaded into the balloon catheter. In the art, under the image guidance of nasal endoscope, send the pharyngeal opening of left side eustachian tube with the sacculus pipe, send into the eustachian tube with the sacculus part, run into obvious resistance until transportation process, show that the ellipsoidal head of inside lining core silk 1 has arrived "gorge portion" of eustachian tube, stop carrying, connect sufficient ware, accomplish the expansion of left side eustachian tube, the toper structure of sacculus 3 is more similar with the eustachian tube structure of digging, it is littleer to the damage of eustachian tube, the effect is better.

After the balloon catheter is removed from the body, the inner core wire 1 is reloaded into the shaping plate 7, the distal end thereof is shaped to 70 degrees along the angle shown in fig. 3, and the inner core wire 1 is reloaded into the balloon catheter. Under the image guidance of nasal endoscope, send the pharyngeal opening of right side eustachian tube with the sacculus pipe, send into right side eustachian tube with the sacculus part, run into obvious resistance until transportation process, show that the ellipsoidal head of inside lining core silk 1 has arrived "gorge portion" of eustachian tube, stop carrying, connect sufficient ware, accomplish the expansion of right side eustachian tube, the toper structure and the eustachian tube of sacculus are separated and are dug the structure more closely, and is littleer to the damage of eustachian tube, and the effect is better.

Claims

1. A balloon catheter for dilating a eustachian tube is characterized in that when the balloon catheter is used, one end far away from an operator is defined as a distal end, and one end close to the operator is defined as a proximal end, and the balloon catheter comprises a catheter main body, a bendable inner lining core wire and a connecting piece for connecting an external filling device; the catheter main body is a double-cavity structure with an inner cavity and an outer cavity; the outer cavity of the catheter main body is a liquid filling cavity which is communicated with the saccule positioned at the far end of the catheter main body; the outer cavity of the catheter main body extends into the balloon, the distal end of the outer cavity is in sealing fit with the balloon to prevent liquid filled in the balloon from overflowing through the distal end of the balloon catheter, and the proximal end of the outer cavity is communicated with a lateral branch of a connecting piece arranged at the proximal end of the catheter main body and used for conveying filling liquid; the inner cavity of the catheter main body is a lining core wire cavity, the far end of the lining core wire is of a spherical structure, and the lining core wire is positioned in the inner cavity except the spherical structure; the proximal end of the lumen is located within the connector.

2. A balloon catheter for dilating a eustachian tube as defined in claim 1, wherein the inner lumen of the catheter body is coaxially disposed with the outer lumen of the catheter body.

3. The balloon catheter for dilating a eustachian tube as claimed in claim 2, wherein the catheter body comprises an outer tube and an inner tube disposed inside the outer tube, a gap between the outer tube and the inner tube being the outer lumen, and an inner lumen of the inner tube being the inner lumen.

4. A balloon catheter for dilating a eustachian tube as claimed in claim 3, wherein the distal end of the balloon is provided with a tip, the distal end of the inner tube being located within the tip; the inner lining core wire penetrates through the inner pipe from the tip end to the inside of the connecting piece at the near end.

5. The balloon catheter for dilating a eustachian tube as claimed in claim 4, wherein the proximal end and the distal end of the balloon are of a first truncated cone shape, the first truncated cone shape at the distal end of the balloon is adapted to be connected to the tip, the first truncated cone shape at the proximal end of the balloon is adapted to be connected to the distal end of the outer tube, and the middle of the balloon is of a cylindrical shape for dilating a diseased tissue.

6. The balloon catheter for dilating a eustachian tube as claimed in claim 5, wherein the middle portion of the balloon is a second truncated cone-shaped structure, the diameter range of the distal end of the second truncated cone-shaped structure is Φ 2.5-4.0 mm, the diameter range of the proximal end of the second truncated cone-shaped structure is Φ 2.75-4.5 mm, and the length of the second truncated cone-shaped structure is 10-25 mm.

7. A balloon catheter for dilating a eustachian tube as claimed in claim 1, wherein the spherical structure of the distal end of the inner lining core wire is spherical or ellipsoidal.

8. A balloon catheter for dilating a eustachian tube as claimed in claim 1, wherein the inner core wire has a spring section at a distal end thereof connected to the balloon structure.

9. A balloon catheter for dilating a eustachian tube as claimed in claim 1, wherein the length of the spring section is 0-80mm, more preferably 20-70mm, or more preferably 35-60 mm.

10. The variable-angle shaping plate is used for shaping the far end of the balloon catheter for expanding the eustachian tube according to claim 1, and is characterized by comprising a shaping plate body, wherein a clamping groove for clamping the inner lining core wire is formed in the shaping plate body, an arc-shaped bend angle is arranged at the end part of the clamping groove, and the far end of the inner lining core wire clamped into the clamping groove is bent to an angle equivalent to the arc-shaped bend angle by the arc-shaped bend angle.