JP2013116220A - Cylindrical member and balloon catheter mounted with the same - Google Patents

Abstract

PROBLEM TO BE SOLVED: To provide a cylindrical member and a balloon catheter using it, the balloon catheter being capable of surely preventing erroneous insertion.SOLUTION: The cylindrical member 23 is mounted on a distal end of the balloon catheter 1, and the cylindrical member 23 is formed of a soluble material to be dissolved by the body fluid or body temperature of a human.

Description

  The present invention relates to a cylindrical member attached to a distal end portion of a balloon catheter, and more particularly to a cylindrical member for increasing the rigidity of a soft distal end portion of a catheter and a balloon catheter to which the cylindrical member is attached. The present invention particularly relates to a gastrostomy catheter and a cystocele catheter.

  Conventionally, gastrostomy catheters, particularly gastrostomy balloon catheters having a balloon are known. As shown in FIG. 9, the balloon catheter has a connection part 133 for connecting a predetermined instrument, a catheter body 103 extending from the connection part 133, and a balloon 113 attached to the distal end of the catheter body 103. And. As shown in FIG. 10, a main lumen 105 penetrating the entire length of the catheter body 103 and a sub-lumen 107 communicating with the balloon 113 are formed inside the catheter body 103. Here, the main lumen 105 communicates with the main connection portion 133a of the connection portion 133, and the sub lumen 107 communicates with the sub connection portion 133b. Further, since the conventional balloon catheter 101 is a gastrostomy catheter, a stopper 143 for fixing the catheter body 103 is provided.

  When this balloon catheter 101 is used as a gastrostomy catheter, as shown in FIG. 10A, the abdominal wall 108 and the stomach wall 109 are punctured to form the fistulas 108a and 109a. Subsequently, the distal end portion of the balloon catheter 101 is inserted into the fistula 108 a formed in the abdominal wall 108 and then the fistula 109 a formed in the stomach wall 109. At this time, the insertion operation is performed in a state where the balloon 113 is not inflated. In a state where the entire balloon 113 is inserted into the stomach wall 109, distilled water is injected into the sub-connecting portion 133b using a syringe (not shown) or the like. As a result, the balloon 113 is inflated, and the balloon catheter 101 can be prevented from coming off the stomach wall 109. Next, the inflated balloon 113 is pulled back so that it slightly contacts the stomach wall 109. Then, the stopper 143 is positioned so as to contact the abdominal wall 108. Through the above operation, the balloon catheter 101 is fixed to the stomach wall 109. However, when the abdominal wall 108 and the stomach wall 109 are sandwiched between the balloon 113 and the stopper 143 with a strong force, there is a possibility of causing compression necrosis. Therefore, it is necessary to appropriately set the sandwiching force.

  When the balloon catheter 101 is fixed, a nutrient bag containing a nutrient is connected to the main connection portion 133a. As a result, the nutrient in the nutrient bag flows into the stomach through the main lumen 105 of the balloon catheter 101. On the other hand, in order to remove the balloon catheter 101, distilled water is discharged from the balloon 113, the balloon 113 is deflated, and the balloon catheter 101 is withdrawn in a state where the distal end portion is narrowed.

  However, the conventional balloon catheter described above has the following problems. That is, the balloon 113 is provided at the distal end portion of the balloon catheter 101. However, since the catheter body 103 and the balloon 113 itself are flexible, the distal end portion of the balloon catheter 101 is easily bent.

  When using such a balloon catheter 101 whose distal end portion is easily bent, the distal end portion of the catheter body 103 that has passed through the fistula 108a of the abdominal wall 108 is inserted into the fistula 109a of the stomach wall 109 as shown in FIG. Without being inserted in the abdominal cavity between the abdominal wall 108 and the stomach wall 109. If a nutrient is injected in such a state, fever, abdominal pain, etc. may be caused.

  An object of the present invention is to provide a cylindrical member made in view of the above problems and a balloon catheter using the cylindrical member, which can reliably prevent erroneous insertion.

  In order to achieve the above object, the present invention is a cylindrical member attached to the distal end portion of a balloon catheter, and the cylindrical member is formed of a soluble material that dissolves by human body fluid or body temperature. The structure is adopted.

  The cylindrical member has a configuration in which one end is hemispherical and the other end is an opening.

  The cylindrical member has a configuration in which one end has a truncated cone shape and the other end is an opening.

  Further, the cylindrical member has a configuration in which both one end and the other end are open.

  The soluble material is formed of at least one material selected from the group consisting of oblate, gelatin, straw, and fats and oils.

  The cylindrical member has a configuration in which a cut is formed at the other end.

  Further, any one of the cylindrical members described above and a balloon catheter including a catheter main body in which the cylindrical member is attached to a balloon at the distal end are employed.

  Further, the cylindrical member is configured not to be deformed when the balloon catheter is inserted into the target site but to be dissolved after the insertion.

  Moreover, the said cylindrical member has taken the structure that it has the length of 1/3-2/3 of the length of a balloon.

  Moreover, the said catheter main body has taken the structure that it is a gastrostomy catheter.

  In addition, the catheter body is configured to include a main lumen that penetrates the entire length of the catheter body and a sub-lumen for inflating the balloon.

  Further, the cylindrical member is configured to be removed from the distal end portion of the catheter body by inflating a balloon by injecting fluid into the main lumen or injecting fluid into the sub-lumen. ing.

It is a top view which shows the balloon catheter of this invention. FIG. 2A is a cross-sectional view showing the structure of the distal end portion of the balloon catheter disclosed in FIG. 1, FIG. 2A shows a state where a cylindrical member is mounted, and FIG. 2B shows a state where the cylindrical member is mounted. Indicates no state. FIG. 3 is a cross-sectional view showing a state in which the main body of the balloon catheter disclosed in FIG. 2 is inserted into the stomach, FIG. 3 (A) shows a state before insertion, and FIG. 3 (B) shows a state after insertion. 4A and 4B are cross-sectional views showing the balloon catheter disclosed in FIG. 3, in which FIG. 4A shows a state where the cylindrical member is removed, and FIG. 4B shows a state where the balloon is inflated. FIG. 5A is a cross-sectional view showing an embodiment in which a cylindrical member is removed by a method different from the embodiment disclosed in FIG. 4, and FIG. 5A is a state in which the balloon is inflated to tear the cylindrical member, and FIG. ) Shows a state in which the cylindrical member is removed. FIG. 6A is a cross-sectional view showing an embodiment using a cylindrical member having both ends opened, and FIG. 6A shows a state in which the tip of the balloon catheter is passing through the abdominal wall and stomach wall. ) Indicates a state in which the balloon is inserted into the stomach. FIG. 7A is a cross-sectional view showing a case where the balloon catheter disclosed in FIG. 6 is inserted using a guide wire, and FIG. 7A shows a state in which the tip of the balloon catheter is passing through the abdominal wall and stomach wall. B) shows a state in which the balloon is inserted into the stomach. It is a figure which shows the example of a cylindrical member, FIG. 8 (A) is a combination of a cylinder and a hemisphere, FIG. 8 (B) is a combination of a cylinder and a truncated cone, FIG. 8 (C1) is only a cylinder. FIG. 8 (C2) is a side view of FIG. 8 (C1). It is a top view which shows the conventional balloon catheter. FIG. 10A is a cross-sectional view showing a case where the conventional balloon catheter disclosed in FIG. 9 is erroneously inserted, FIG. 10A shows a state before insertion, and FIG. 10B shows a state after erroneous insertion.

  Hereinafter, an embodiment of the present invention will be described with reference to the drawings. Note that the following description of the embodiment is not intended to limit the present invention, but includes improvements, improvements, and changes other than the described embodiment.

Specifically, the balloon catheter according to the present invention can be used as a bladder fistula catheter in addition to being used as a gastrostoma catheter. Bladder fistula is a urinary diversion that enables urination without passing through the urethra when the part involved in urination function is damaged and the bladder cannot maintain normal function. In this method, a catheter is directly inserted into the urine.
[Overview]
First, based on FIG. 1, the balloon catheter 1 which concerns on one Embodiment of this invention is demonstrated. The balloon catheter 1 according to this embodiment includes a pipe-shaped catheter body 3, a balloon 13 attached to the distal end portion of the catheter body 3, a cylindrical member 23 attached to the outer peripheral portion of the balloon 13, and a catheter body. 3 and a connecting portion 33 connected to the base end portion. Furthermore, the balloon catheter 1 of this embodiment is a gastrostomy catheter, and a stopper 43 is provided in the vicinity of the distal end portion of the catheter body 3. The position of the stopper 43 can be changed along the catheter body 3.
[Catheter body]
As shown in FIG. 2, the catheter body 3 is a pipe-shaped member having a lumen formed therein. The lumen includes a main lumen 5 penetrating the entire length of the catheter body 3 and a sub-lumen 7 communicating with the inside of the balloon 13 at the distal end. The main lumen 5 is for introducing a nutrient into the stomach. On the other hand, the secondary lumen 7 is for supplying distilled water necessary to inflate the balloon 13.

The catheter body 3 is a member having a diameter of about 2 to 10 mm formed from a soft material such as silicon rubber. For this reason, it has the property which deform | transforms easily with respect to external force. The material of the catheter body 3 is not limited to silicon rubber, and PVC, fluororubber, fluororesin, polyurethane, etc. can be used.
[balloon]
A balloon 13 is provided on the outer peripheral surface of the distal end portion of the catheter body 3. The balloon 13 is inflated inside the stomach wall to prevent the balloon catheter 1 from coming out of the stomach wall. As described above, the inside of the balloon 13 communicates with the secondary lumen 7 of the catheter main end 3 and is inflated by distilled water introduced from the secondary lumen 7.
[Cylindrical member]
A cylindrical member 23 is attached to the outer peripheral surface of the balloon 13. The cylindrical member 23 is for increasing the rigidity of the distal end portion of the catheter body 3. As described above, the distal end portion of the catheter body 3 has a property of being easily bent, but the rigidity is increased by the cylindrical member 23 so that the catheter body 3 can be appropriately inserted into the fistula of the abdominal wall or stomach wall.

  The cylindrical member 23 disclosed in FIGS. 1 to 5 has a shape in which a cylinder and a hemisphere (dome) are combined. That is, one end of the cylinder is closed by a hemisphere, and the other end is an opening. The inner diameter of the cylinder is slightly larger than the outer shape of the balloon 13 in a contracted state, and can be easily attached to the outer peripheral portion of the balloon 13.

As the material of the cylindrical member 23, any material can be used as long as it is a soluble material that dissolves at a human body fluid or body temperature and is harmless to the human body. As the most common ones, materials used for pharmaceutical capsules, wafers, agar and the like can be considered. Further, it may be an oily material that is solid at low temperatures and dissolves at body temperature. Furthermore, a material having a property of being dissolved in gastric juice, such as so-called sputum, may be used.
[Connection]
Next, the connection part 33 is demonstrated. The connecting portion 33 is a member connected to the proximal end portion of the catheter body 3. The connecting portion 33 includes a main connecting portion 33a and a sub connecting portion 33b, and has a shape that branches from the catheter body 3 in a Y shape. The main connection portion 33a is a cylindrical member having a slight taper, and is connected to a nutrient solution supply pipe (not shown) extending from the nutrient solution bag. On the other hand, the sub-connecting portion 33b has a connector portion at its end, and a syringe can be connected to the connector portion. As described above, the main connection portion 33 a communicates with the main lumen 5, while the sub connection portion 33 b communicates with the inside of the balloon 13 through the sub lumen 7.
[Tip of balloon catheter]
Next, the structure of the distal end portion of the balloon catheter 1 will be described with reference to FIG. Here, FIG. 2 (A) shows a cross-sectional view of the distal end portion of the balloon catheter 1 with the cylindrical member 23 attached, and FIG. 2 (B) shows a cross-sectional view with the cylindrical member 23 removed. Show. As shown in FIG. 2A, the catheter body 3 has a main lumen 5 formed in the vicinity of the center thereof, and a sub-lumen 7 is formed between the main lumen 5 and the outer peripheral surface. Yes. A balloon 13 is provided on the outer periphery of the distal end of the catheter body 3, and the end of the sub-lumen 7 is open inside the balloon 13. Here, although the balloon 13 is described as a member different from the catheter body 3, the present invention is not limited to this and may be manufactured integrally with the catheter body 3. Further, the balloon 13 is described with emphasis on the thickness for convenience of explanation, but actually, the balloon 13 is composed of a member that is considerably thinner than the diameter of the catheter body 3. Further, in FIG. 2, it is described that a space is formed between the catheter body 3 and the balloon 13 even when the balloon 13 is deflated, but actually, the space is in contact with the surface of the catheter body 3. It is in a state.

A cylindrical member 23 is attached to the outer peripheral surface of the balloon 13. The cylindrical member 23 has a length of about 1/3 to 2/3 of the length of the balloon. However, the length may cover the entire balloon, or may have a longer overall length beyond the length of the balloon. FIG. 2B is a cross-sectional view of the distal end portion of the balloon catheter 1 with the cylindrical member 23 removed. This is the same structure as a conventional balloon catheter.
Insert process
Next, based on FIG.3 and FIG.4, the insertion process of the balloon catheter 1 of this embodiment is demonstrated. In this embodiment, since a gastrostomy catheter is taken as an example, a process of inserting into the fistulas 8a and 9a of the abdominal wall 8 and the gastric wall 9 will be described.

  First, the abdominal wall 8 and the stomach wall 9 are punctured to form the fistulas 8a and 9a (FIG. 3A). Prior to the formation of the fistulas 8a, 9a, the abdominal wall 8 and the stomach wall 9 are stitched at several places, and the abdominal wall 8 and the stomach wall 9 are fixed to each other, so that puncture can be easily performed. In addition, the gastric wall 8 and the abdominal wall 9 can be prevented from dissociating before the formation of the fistulas 8a, 9a.

  With the fistulas 8a and 9a formed in the abdominal wall 8 and the stomach wall 9, the balloon catheter 1 to which the cylindrical member 23 is attached is inserted into the fistulas 8a and 9a (FIG. 3B). At this time, the rigidity of the distal end portion of the balloon catheter 1 is increased because the cylindrical member 23 is attached. For this reason, even when an external force is applied to the distal end portion of the catheter body 1 so as to be bent, the catheter body 1 is reliably inserted into the fistula 9a of the stomach wall 9 without being bent due to the increased rigidity.

With the entire balloon 13 inserted into the stomach, the insertion of the balloon catheter 1 is stopped. Next, distilled water or clean air is injected into the main lumen 5 from the main connection portion 33a. Thereby, the injected distilled water etc. will remove the cylindrical member 23 from the front-end | tip of the catheter main body 3 (FIG. 4 (A)). With the cylindrical member 23 removed, distilled water is supplied into the balloon 13 and the balloon 13 is inflated (FIG. 4B). Fixing of the balloon catheter 1 is completed by bringing the stopper 43 into contact with the abdominal wall 8 while the balloon 13 is in contact with the inner surface of the stomach wall. This makes it possible to replenish nutrients from the main lumen 5.
[Another way to remove the cylindrical member]
FIG. 5 is a diagram for explaining how to remove the cylindrical member 23 using a method different from that in FIG. 4. The cylindrical member 23 has a slight cut 23a in the opening at the other end (FIG. 5A). Then, the balloon 13 is inflated in a state where the cylindrical member 23 is attached to the distal end portion of the catheter body 3. As the balloon 13 is inflated, the cut 23a is expanded, and the balloon 13 is further inflated, whereby the cylindrical member 23 is torn and detached from the distal end portion of the balloon catheter 1 (FIG. 5B). The removal method does not require an additional operation such as injection of distilled water into the main lumen 5, and can be realized only by performing a normal balloon inflation operation, so that the treatment is not complicated.
[Modified example of cylindrical member]
FIG. 6 is a diagram illustrating an example in which a cylindrical member having a shape different from that of the cylindrical member 23 disclosed in FIGS. 1 to 5 is used. As shown in this figure, the cylindrical member 23b of this embodiment consists of only a cylinder. Since the purpose of the present invention is to increase the rigidity of the distal end portion of the catheter body 3, it is not always necessary to close one end portion of the cylindrical member. As shown in FIG. 6 (A), the distal end portion of the catheter body 3 is enhanced in rigidity by the cylindrical member 23b, so that it can be reliably inserted into the fistula 9a of the stomach wall 9 without bending.

When the distal end portion of the catheter body 3 is inserted into the fistula 9a, the diameter of the cylindrical member 23b is such that the inner diameter of the cylindrical member 23b substantially matches the outer shape of the balloon 13. Is desirable. By doing so, the coefficient of friction between the cylindrical member 23b and the balloon 13 is increased, and positional displacement can be reliably prevented. Then, the balloon 13 is inflated in a state where the entire balloon 13 is inserted into the stomach wall 9. The cylindrical member 23 b is torn by the expansion of the balloon 13 and is removed from the distal end portion of the catheter body 3.
[Example of insertion using a guide wire]
FIG. 7 is a diagram illustrating an example in which the balloon catheter 1 disclosed in FIG. 6 is inserted using the guide wire W. Prior to inserting the balloon catheter 1, a guide wire W is inserted into the fistulas 8a and 9a. Since the guide wire W is thinner than the catheter body 3, it can be easily inserted into the fistulas 8a and 9a, and the catheter body 3 can be guided and reliably guided into the stomach wall 9. FIG. 7A shows a state in which the guide wire W is guided through the main lumen 5. Since the guide wire W passes through the fistulas 8a and 9a of the abdominal wall 8 and the stomach wall 9, and the cylindrical member 23b is attached, the fistula of the gastric wall 9 is surely secured without bending the distal end portion of the catheter body 3. 9a.

Then, the guide wire W is pulled out with the entire balloon 13 being inserted into the stomach wall 9. Thereafter, the balloon 13 is inflated, and the cylindrical member 23 b is torn by the expansion of the balloon 13 and is removed from the distal end portion of the catheter body 3. When the guide wire W is used, one end of the cylindrical member 23b needs to be an opening. For this reason, the cylindrical member 23b disclosed in FIG. 6 is appropriate.
[Other examples of cylindrical members]
FIG. 8 is a diagram illustrating an example of a cylindrical member. FIG. 8A is disclosed in FIGS. 1 to 5 and is a combination of a cylinder and a hemisphere. FIG. 8B shows a combination of a cylinder and a truncated cone. Thus, by using one end of the cylindrical member 23d as a truncated cone, the distal end of the catheter body 3 can be reliably inserted into the fistulas 8a and 9a. In the embodiment shown in FIGS. 8A and 8B, a small hole through which the guide wire W passes may be formed at one end. Further, FIG. 8C1 is a front view of a cylindrical member 23b consisting only of a cylinder, and FIG. 8C2 is a side view thereof. The cylindrical member 23b is open at both ends.

  When used for a cystocele catheter, basically the stomach wall is simply replaced with the urinary bladder wall, so that it can be used as a cystocele catheter by the same idea as described above.

  The present invention can be used for balloon catheters, particularly gastrostomy catheters and cystocele catheters.

DESCRIPTION OF SYMBOLS 1 Balloon catheter 3 Catheter main body 5 Main lumen 7 Sub lumen 8 Abdominal wall 8a Fistula 9 Gastric wall 9a Fistula 13 Balloons 23, 23b, 23d Cylindrical member

Claims (12)

  A cylindrical member attached to a distal end portion of a balloon catheter, wherein the cylindrical member is formed of a human body fluid or a soluble material that is dissolved by body temperature.   The cylindrical member according to claim 1, wherein the cylindrical member has a hemispherical shape at one end and an opening at the other end.   The cylindrical member according to claim 1, wherein the cylindrical member has a truncated cone shape at one end and an opening at the other end.   The cylindrical member according to claim 1, wherein both the one end and the other end of the cylindrical member are open.   5. The cylindrical shape according to claim 1, wherein the soluble material is formed of at least one material selected from the group consisting of wafers, gelatin, straw, and fats and oils. Element.   The cylindrical member according to any one of claims 1 to 5, wherein the cylindrical member has a cut at the other end.   The cylindrical member according to any one of claims 1 to 6, wherein the cylindrical member is not deformed when the balloon catheter is inserted into a target site and is dissolved after the insertion.   A balloon catheter comprising the cylindrical member according to any one of claims 1 to 7 and a catheter body in which the cylindrical member is attached to a balloon at a distal end portion.   The balloon catheter according to claim 8, wherein the cylindrical member has a length of 1/3 to 2/3 of a length of the balloon.   The balloon catheter according to claim 8 or 9, wherein the catheter body is a gastrostomy catheter.   The said catheter main body is equipped with the main lumen which has penetrated the full length of the catheter main body, and the sub lumen | bore for inflating the said balloon, It is any one of Claims 8-10 characterized by the above-mentioned. Balloon catheter.   The cylindrical member is removed from the distal end portion of the catheter body by inflating a balloon by injecting fluid into the main lumen or injecting fluid into the sub-lumen. Item 12. The balloon catheter according to Item 11.

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