JP2581611Y2 - Balloon catheter for medical device - Google Patents

Description

[Detailed description of the invention]

[0001]

BACKGROUND OF THE INVENTION 1. Field of the Invention The present invention relates to a balloon catheter for mounting a medical device for hermetically fixing a medical device to be inserted into a body cavity percutaneously to a body surface.

[0002]

2. Description of the Related Art Laparoscopic surgery is performed by inserting a medical instrument, for example, a trocar, through the skin of the abdomen into the abdominal cavity after pneumoperitoneum and inserting a laparoscope or various treatment tools therethrough. It is. Conventionally used trocars include metal products, as well as disposable products that eliminate unevenness in the insertion sensation due to reduced sharpness of the needle tip due to repeated use. In order to prevent damage to internal organs and to maintain a pneumoperitoneum state during the operation, a degassing prevention valve mechanism at the treatment instrument insertion port has been devised, and provided to the surgeon as an almost satisfactory instrument.

[0003] During the operation, when it is necessary to frequently insert or remove a treatment instrument through the trocar or to apply force to the instrument, the trocar naturally falls out of the abdominal wall without the operator's notice, and it takes time to reinsert. There is. To solve such a problem, there has been known a device in which the trocar is provided with a screw-shaped structure by integral molding or post-processing, and after insertion, is securely screwed into the abdominal wall. However, screwing the sharp structure into the abdominal wall is not preferable because it causes damage and bleeding of the abdominal wall tissue, delays postoperative healing, and enlarges wound scars.

[0004] For example, in cases of a history of lower abdominal surgery,
The patient has severe adhesions to the abdominal cavity and is difficult to puncture normally. A trocar is inserted after a small incision in the abdominal wall. In this case, in the above-mentioned screw-shaped structure, not only the puncture hole is too large to fix, but also insufflation gas leaks, and complicated procedures such as partial suturing are required.

In view of such a situation, the present inventors have provided two balloons on the outer surface of a cylindrical member, attached these to a trocar, and pierced the abdominal wall. A device for fixing the trocar with the abdominal wall sandwiched between the two balloons by inflating the balloon when it enters the inside is devised.
Issue. In this mounting balloon catheter, a front branch tube for inflating and deflating the distal balloon is
During the operation, the abdominal wall is strongly compressed, and the flow path from the check valve to the tip balloon may be blocked, causing gas-liquid flow failure. there were.

[0006]

SUMMARY OF THE INVENTION The present invention has been made as a result of various studies to solve the above-mentioned problems of the means for fixing the trocar to the abdominal wall. A trocar fixing means that can be easily attached to the trocar, has no puncture obstruction, reduces damage to abdominal wall tissue, can securely and hermetically fix the trocar to the abdominal wall, and can reliably perform inflation and contraction of the balloon portion. To provide.

[0007]

In order to achieve the above object, a balloon catheter for mounting a medical device according to the present invention comprises an inner cylinder made of a thin tube and an outer cylinder made of a stretchable elastic material. The inner and outer cylinders are adhered at the front end, the rear end, and the central portion to form a front balloon and a rear balloon, and the front end side opens between the inner and outer cylinders and opens into the front balloon and the rear end side. Is composed of a front branch tube branched at the rear end of the balloon portion, and a rear branch tube branched at the rear end portion of the balloon portion, with the front end opening between the inner and outer cylinders and opening into the rear balloon. A gas-liquid opening / closing device having a connector for connection is provided at the rear ends of the two branch tubes, and a reinforcing tube is inserted between the front balloon and the rear balloon in the front branch tube. I do.

[0008]

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS Hereinafter, the present invention will be described in detail with reference to the illustrated embodiments. FIG. 1 is a schematic view of a balloon catheter for mounting a medical device according to the present invention, FIG. 2 is a sectional view showing the structure of a balloon section, and FIG. 3 is a schematic view showing a use state.

The balloon catheter for mounting a medical device according to the present invention comprises a balloon portion (1), a front branch tube (7) and a rear branch tube (8) connected to a rear end thereof, and a rear end of both branch tubes. It is composed of pilot balloons (9) and (10) which are connected and have check valves (11) and (12).

The balloon portion (1) has a structure in which an inner tube (15) is overlapped with an outer tube (16) made of an elastic material which can be expanded and contracted, and a distal end adhesive portion (4) and a central adhesive portion (5). The inner and outer cylinders are adhered to each other at the rear end adhesive part (6), and the inner cylinder (15) and the outer cylinder (16) are peeled off from each other to form the front balloon (2) and the rear balloon (3). I do. In addition, the inner cylinder (1
5) and the outer tube (16), a leading branch tube (7) and a trailing branch tube (8) are respectively provided in the axial direction from the trailing end of the balloon portion (1) to the leading balloon (2) and the trailing balloon. It is guided so as to allow gas-liquid flow to (3), and is bonded and fixed at each bonding portion. Further, a reinforcing tube (17) is inserted into a portion between the front balloon (2) and the rear balloon (3) in the front branch tube (7), and the front branch tube (7) is crushed at this portion during use. And the gas-liquid circulation to the balloon (2) can be more reliably performed.

The inner cylinder (15) has an inner diameter corresponding to the outer diameter of a commercially available trocar outer cylinder (21), and has a thickness of 0.1 to 0.1 mm.
It is a thin tube with a thickness of 2 mm, and is made of a material having appropriate flexibility and elasticity such as soft vinyl chloride resin, polyurethane resin, silicone rubber, and natural rubber by a method such as extrusion molding or dipping. However, it is not always necessary to limit the tube to a flexible tube. When the trocar is inserted into the abdominal wall by being attached to the trocar outer cylinder (21), it is important to select an inner diameter and flexibility that does not shift due to frictional resistance with the tissue surrounding the puncture hole.

The outer cylinder (16) is a tube-like elastic member having a thickness of 0.1 to 0.5 mm forming a balloon. It is made of a stretchable material by extrusion or dipping. The inner cylinder (1) is attached at each of the bonding portions at the front end (4), the center (5), and the rear end (6).
5) is bonded, and the space between the bonded portions becomes a balloon. It is appropriate that the bulge of the balloon when inflated is 5 to 30 mm, and the axial lengths of the front balloon (2) and the rear balloon (3) are each 5 to 30 mm. The distance between the two balloons, that is, the axial length of the central bonding portion (5) is
Corresponds to the thickness of the patient's abdominal wall, usually 10-15m
m, but it is preferable to prepare several types in the range of 5 to 30 mm in consideration of the thickness of the subcutaneous fat layer, which has individual differences. In addition, when the trocar is adhered to the trocar outer cylinder (21) and penetrates into the abdominal wall, frictional resistance with tissue around the insertion hole is reduced,
It is important to reduce the damage to living tissue, and the tip of the balloon (1) should be rounded or tapered to minimize the bulk when both balloons are deflated. preferable.

In the embodiment shown in FIG. 2, the inner cylinder (15) and the outer cylinder (16) are made as separate parts.
When a liquid material such as silicone rubber or natural rubber is used for forming the outer tube (16), a release agent is applied to the surface of the inner tube (15) where a balloon is to be formed.
Dip molding can be performed integrally. Further, the outer cylinder (16) may be formed of a part obtained by dividing the front balloon (2) and the rear balloon (3). Further, the inner tube (15) and the outer tube (16) are bonded by a central bonding portion (5), and a portion of the outer tube (16) where each balloon is formed is shaped into a balloon in advance. 1
A method of providing a locally enlarged portion by forming a single balloon and thinning portions corresponding to the front balloon (2) and the rear balloon (3) as compared with the portion corresponding to the central bonding portion (5). Can also satisfy the function of the present invention. At this time, only one conduit device may be used for inflating the balloon, but it is necessary to devise a method for surely inflating the front and rear enormous portions.

As shown in FIG. 2, the leading end tube (7) and the trailing branch tube (8) have the inner tube (15) at their distal ends.
And a tube which passes through the outer tube (16) and opens into the front balloon (2) and the rear balloon (3), respectively, and is led therethrough in a gas-liquid flow to the rear end of the balloon portion (1). It is. As shown in FIG. 1A, independent tubes may be used, but as shown in FIG.
The inside and the vicinity of the rear end may be branched by using a two-chamber tube (3) having two flow passages integrated with each other and providing a branch (14) at a rear position. As the material, for example, soft vinyl chloride resin, urethane resin,
Extruded 0.3 to 2m inner diameter using material with moderate flexibility and hardness such as silicone rubber and natural rubber
m, a tube having a substantial wall thickness of 0.3 to 1.5 mm is preferred. Further, the length of the branch tube is suitably about 30 to 200 mm as a convenient length so as not to hinder the operator from putting in and taking out various treatment tools using the trocar.

Further, check valves (11) and (12) each having a connector serving as a gas-liquid opening / closing device are provided at the rear ends of the leading branch tube (7) and the trailing tube (8), or a two-way cock or A three-way cock or the like is connected, and the structure is such that it can be easily opened and closed by attaching and detaching a syringe, which is a general balloon inflation and injection device. Further, pilot balloons (9) and (10) may be connected between the branch tubes (7) and (8) and the check valves (11) and (12). The balloon is formed of a material having appropriate flexibility and elasticity, such as silicone rubber and natural rubber, so that the balloon inflation condition can be monitored. These members can sufficiently fulfill the function of the gas-liquid opening / closing device using only a general two-way cock.

The portion between the front balloon (2) and the rear balloon (3) may be only the front branch tube (7) opened in the front balloon (2), but it is strongly compressed at the abdominal wall. The leading branch tube may be crushed and the flow path from the check valve to the tip balloon may be blocked, and gas-liquid flow may be impaired.
In some cases, inflation and deflation of the tip balloon (2) cannot be performed reliably. In order to prevent such a situation, as shown in FIG. 2, when a reinforcing tube (17) having an appropriate hardness such as a fluororesin is inserted into the leading branch tube (7), the tube is strongly compressed by the abdominal wall. However, an airway to the front balloon (2) can be secured, a more reliable function of gas-liquid circulation can be achieved, and the expansion and contraction of the front balloon (2) can be reliably performed.

In using the balloon catheter according to the present invention, as shown in FIG. 3, for example, a lubricant is applied to the outer tube (21) of the trocar, if necessary, and the balloon portion (1) is attached thereto. Abdominal wall (1
9) Puncture the tip of the balloon (2) into the abdominal cavity (20)
Once inside, it is inflated by injecting air or saline from the check valve (12). Here, after pulling the trocar grasping portion (18) and bringing the front balloon (2) into close contact with the inside of the abdominal wall (19), the rear balloon (3) is similarly expanded outside the body to inflate the abdominal wall (19) with the front balloon (19). 2)
The trocar outer cylinder (21) is airtightly fixed to the body surface so as to be sandwiched between the two balloon inflatable portions of the rear balloon (3) and the rear balloon (3).

[0018]

The balloon catheter for mounting a medical device according to the present invention can be easily mounted on a medical device inserted percutaneously into a body cavity, for example, a trocar, and has a moderate flexibility and elasticity so as to be in close contact with the outer tube of the trocar. In addition, since there is little bulkiness that causes insertion resistance, percutaneous insertion can be performed safely and easily without displacement.

In addition, by having two balloon inflatable portions and inflating the inside and outside of the body cavity, the percutaneous insertion port can be fixed so as to be sandwiched between the inside and outside of the body, so that the trocar can be fixed securely and is flexible. Since the inflatable balloon having elasticity and elasticity comes into contact with the body wall, tissue damage is minimized, and the inflatable balloon is freely deformed according to the operator's trocar operation angle, so that the insertion port and the trocar can be The gap can be reliably hermetically sealed. Furthermore, even if the insertion opening is smaller than the outer diameter of the trocar and has a larger gap in the insertion opening which is slightly incised depending on the case, the hermetic seal can be easily and surely sealed by increasing the balloon expansion diameter.

In addition, the forearm tube into which the reinforcing tube is inserted does not collapse even when strongly pressed by the abdominal wall, and a gas-liquid circulation airway to the forehead balloon can be secured, and the inflation and contraction of the forehead balloon can be ensured. Can be done.

[0021]

[Effects of the Invention] As described above, the balloon catheter for mounting a medical device of the present invention can be easily mounted on a medical device, does not interfere with percutaneous insertion, and reduces damage to tissues around the insertion port. It reduces unnecessary bleeding and reduces the burden on the patient. In addition, when the trocar is inserted, the balloon can be reliably expanded and fixed, while preventing natural dropout during operation and leakage of insufflation gas, and unnecessary complicated work such as reinserting the trocar and securing the operation field. Therefore, the safety of the operation can be further improved. Therefore, medical instruments inserted percutaneously into the body cavity in laparoscopic surgery,
For example, it is useful as a balloon catheter for mounting a medical device for hermetically fixing a trocar to a body surface.

[Brief description of the drawings]

FIG. 1 is a schematic view showing a configuration of a balloon catheter for mounting a medical device according to an embodiment of the present invention.

FIG. 2 is a cross-sectional view showing a structure of a balloon portion of the balloon catheter for mounting a medical device according to the present invention.

FIG. 3 is a schematic view showing a use state of the balloon catheter for mounting a medical device of the present invention.

[Explanation of symbols]

 Reference Signs List 1 balloon portion 2 front balloon 3 rear balloon 4 front bonding portion 5 center bonding portion 6 rear bonding portion 7 front branch tube 8 rear branch tube 9,10 pilot balloon 11,12 check valve 13 two-lumen tube 14 branching portion 15 Tube 16 outer tube 17 reinforcing tube 18 trocar gripper 19 abdominal wall 20 abdominal cavity 21 trocar outer tube

Continuation of front page (58) Field surveyed (Int.Cl. ⁶ , DB name) A61M 25/00

Claims (1)

(57) [Scope of request for utility model registration] 1. An inner cylinder made of a thin tube and an outer cylinder made of a stretchable elastic material are overlapped with each other, and the inner and outer cylinders are bonded at a front end, a rear end, and a center of the tube, and the front balloon is connected to the front balloon. A balloon portion having a rear balloon formed therein, a front end side opening between the inner and outer cylinders into the front balloon and a rear end side branching at the rear end portion of the balloon portion, and a front end portion between the inner and outer cylinders. The rear end side is composed of a rear branch tube branched at the rear end of the balloon part, and a gas-liquid opening / closing device having a connector for connection is provided at the rear end of both branch tubes. A balloon catheter for mounting a medical device, wherein a reinforcing tube is inserted into a region between a front balloon and a rear balloon in a front branch tube.