JP5886542B2 - Medical device - Google Patents

Description

  The present invention provides a medical device including an introduction main body to be inserted into the body and an attachment portion to which the distal end portion of the endoscope can be attached, and an expandable / contractible bumper for being placed in the body in front of the attachment portion. About.

  Conventionally, percutaneous endoscopic gastrostomy (PEG (abbreviation of Percutaneous Endoscopic Gastrostomy)) that forms a fistula in the stomach using an endoscope is known as a method for enteral nutrition administration. As a new method of enteral nutrition administration after gastric surgery or ascites retention where PEG is difficult, percutaneous transesophageal gastrostomy (PTEG (Percutaneous Trans Esophageal Gastrortubing), which forms a fistula not in the stomach, )) Is also known.

  In PTEG, a balloon catheter is inserted nasally into the esophagus, the balloon is inflated with a contrast medium or the like at the puncture portion in the cervical esophagus, and the puncture is performed while aiming at the balloon under fluoroscopy. As a result, it is possible to construct a cervical esophageal fistula safely and minimally invasively. Therefore, a device for improving safety has been desired.

  As a conventional technique capable of solving such a problem, for example, as disclosed in Patent Document 1, a puncture balloon for securing a route for approaching the body percutaneously safely and surely has already been proposed. Has been. This was configured to use as a target a balloon that does not burst immediately even when punctured with a puncture needle or the like.

WO2004 / 067080

  However, in the conventional technique described in Patent Document 1 described above, as a balloon that does not immediately burst even when punctured, specifically, a synthetic resin having a hardness of JIS A 20 to 80 degrees, a tensile strength of 8 to 25 MPa, and a tear strength of 20 to 60 kg. Molded with limited special materials such as / cm. Since such a special material is relatively expensive, there is a problem that it causes an increase in cost. In addition, even if the balloon does not rupture, there is a possibility that the posterior wall of the esophagus may be erroneously punctured by the needle tip protruding through the balloon coating.

  The present invention has been made paying attention to the problems of the conventional technology as described above, and when puncturing from outside the body while indwelling in the body, there is a risk of erroneously puncturing a body tissue other than the puncture site. For the purpose of providing a medical device that not only can improve safety, but also can be manufactured at low cost using common materials, and can achieve significant cost reductions. Yes.

The gist of the present invention for achieving the object described above resides in the inventions of the following items.
[1] The introduction body (11) to be inserted into the body is provided with an attachment portion (12) to which the distal end portion (41) of the endoscope (40) can be attached, and in front of the attachment portion (12) in the body. In the medical device (10) provided with an expandable / contractible bumper (30, 30A) for placement,
When puncturing from outside the body toward the bumper (30, 30A) in a state where the bumper (30, 30A) is expanded and left in the body in the introduction body (11), the penetration body (11) is penetrated. a protective material to prevent (20,20A),
A hollow portion (13) for securing a lumen even when the bumper (30, 30A) contracts is provided in front of the bumper (30, 30A) in the introduction main body (11). A medical device (10) featuring.

  [2] The medical material according to [1], wherein the protective material (20, 20A) is made of a metal mesh material developed in a planar shape at a predetermined position of the introduction main body (11). Device (10).

[ 3 ] The medical device (10) according to [ 1] or [2 ], wherein a part of the introduction body (11) in the circumferential direction surrounding the hollow portion (13) is opened in a slit shape. ).

[4] The introduction body (11) is for between the outer periphery leaving a front end and a rear end portion of the tubing of flexible material is him notch in a predetermined range in the axial direction and circumferential direction,
The rear end portion is the attachment portion (12) to which the distal end portion (41) of the endoscope (40) can be attached in a cylindrical interior,
As for the front end portion, the inside of the cylinder becomes the hollow portion (13) as it is,
The protective material (20, 20A) is provided on the lumen side of the arc-shaped cross section excluding the front end portion and the rear end portion, and the bumper (30, 20A) is disposed at a position overlapping the protective material (20, 20A). The medical device (10) according to [1], [2] or [3], wherein a balloon made of an elastically deformable material is provided as 30A).

[ 5 ] The balloon is formed of a transparent material and disposed at a position where the balloon contacts the lens on the distal end side of the endoscope (40) attached to the attachment portion (12) when the balloon is inflated. the medical device according to [4], wherein (10).

[6] The balloon, said characterized in that provided on the elastically deformable shape over the entire circumferential direction of the tube member in a state in which outside covering not the luminal side only of said arcuate cross section [4 ] Or the medical device (10) as described in [ 5 ].

[ 7 ] The above [1], characterized in that the introduction main body (11) is provided with a metal bar (21) for confirming the orientation of the introduction main body (11) under an ultrasonic image. The medical device (10) according to [2], [3], [4], [5] or [6 ] .

The present invention operates as follows.
According to the medical device (10) described in [1], when the introduction body (11) is inserted into the body, the bumpers (30, 30A) provided in the introduction body (11) are contracted. In addition, by attaching the endoscope (40) to the mounting portion (12) provided on the rear side of the bumper (30, 30A), a desired position in the body while checking the image of the endoscope (40) The introduction body (11) can be inserted up to.

  When the introduction body (11) reaches a desired position in the body, the bumper (30, 30A) is expanded and placed at the position. For example, when the introduction body (11) is inserted into the esophagus orally or nasally, it can be placed by expanding the bumper (30, 30A) larger than the esophageal lumen.

In this state, puncture is performed from outside the body toward the bumper (30, 30A) while confirming with an endoscope (40) image or an ultrasonic (echo) image. Here, since the introduction body (11) is provided with a protective material (20, 20A) for preventing penetration when puncturing, there is no risk of erroneous puncturing of internal tissues such as the posterior wall of the esophagus, thereby improving safety. Can do. Furthermore, since an endoscope is used, the degree of esophageal damage at the time of puncture can always be confirmed. In addition, a hollow portion (13) is provided in front of the bumper (30, 30A) in the introduction main body (11) to secure a lumen even when the bumper (30, 30A) contracts. Even if the bumper (30, 30A) contracts unexpectedly, collapse of the body cavity at the indwelling position can be prevented, and a minimum lumen can be secured.

  Specifically, as the protective material (20, 20A), for example, as described in [2] above, a metal mesh material developed in a plane at a predetermined location of the introduction main body (11) may be used. Can be manufactured relatively inexpensively.

According to the medical device (10) described in [ 3 ], a part of the circumferential direction surrounding the hollow portion (13) in the introduction main body (11) is opened in a slit shape. Thereby, the catheter etc. which were allowed to pass through the hollow part (13) after puncture can be easily taken out in the radial direction from the axial center of the hollow part (13).

According to the medical device (10) described in [ 4 ], the introduction body (11) leaves the front end portion and the rear end portion of the tube material made of a flexible material, and the outer periphery between them is axial and circumferential. Are cut out in a predetermined range. Here, the rear end portion is the mounting portion (12) in which the tip end portion (41) of the endoscope (40) can be mounted in a cylindrical interior, and the front end portion of the hollow portion is the cylindrical interior as it is. (13)

  And the said protective material (20, 20A) is provided in the lumen | bore side of the circular-arc-shaped cross-section part except the front end part and rear end part in the introduction main body (11), and the position which overlaps with this protective material (20, 20A) The bumper (30, 30A) is provided with a balloon made of an elastically deformable material. Thereby, a medical device (10) can be manufactured inexpensively with a relatively simple configuration.

Here, as described in the [5], and of a transparent material the balloon is distal of the endoscope mounted on the mounting portion (12) when inflated the balloon (40) When the lens is disposed at a position where it abuts on the lens, a clearer visual field in the endoscope (40) can be secured.

As another configuration, as described in [ 6 ] above, the balloon can be elastically deformed over the entire circumference of the tube material in a state of covering not only the lumen side but also the outer side of the arc-shaped cross section. It may be provided in a shape. According to such a configuration, since the protective material (20, 20A) is located not at the end of the balloon but at the center, it is easy to confirm the position of the protective material (20, 20A) even in an ultrasonic (echo) image, Since the protective material (20, 20A) is surrounded by the balloon in the entire circumferential direction, the center of the balloon can be reliably punctured aiming at the protective material (20, 20A).

Furthermore, according to the medical device (10) described in [ 7 ], the introduction body (11) is made of a metal for confirming the orientation of the introduction body (11) under an ultrasonic (echo) image. By providing the bar material (21), the orientation of the introduction main body (11) and the bumper (30, 30A) can be easily confirmed under the ultrasonic (echo) image, and clearly when puncturing. You can also

  According to the medical device of the present invention, when puncturing from outside the body while indwelling in the body, there is no possibility of erroneously puncturing body tissue other than the puncture site, and not only can safety be improved. Therefore, it is possible to manufacture at a low cost by using a general material, and a significant cost reduction can be realized.

It is a front view which shows the state which connected the tube for delivery to the medical device which concerns on 1st Embodiment of this invention. It is a top view which shows the medical device which concerns on 1st Embodiment of this invention. It is a left view which shows the medical device which concerns on 1st Embodiment of this invention. It is a right view which shows the medical device which concerns on 1st Embodiment of this invention. It is a front view which shows the state which connected the tube for delivery to the medical device which concerns on 1st Embodiment of this invention, and equipped with the endoscope. It is a front view which shows the state which expanded the bumper of the medical device which concerns on 1st Embodiment of this invention. It is explanatory drawing which shows the state which punctures the bumper which the medical device which concerns on 1st Embodiment of this invention was orally inserted in the esophagus and expanded. It is a top view which shows the medical device which concerns on 2nd Embodiment of this invention. It is a front view which shows the state which expanded the bumper of the medical device which concerns on 2nd Embodiment of this invention.

Hereinafter, various embodiments representing the present invention will be described with reference to the drawings.
1 to 7 show a first embodiment of the present invention.
FIG. 1 is a front view showing a state in which a delivery tube 15 is connected to the medical device 10. 2 is a plan view showing the medical device 10, FIG. 3 is a left side view showing the medical device 10, and FIG. 4 is a right side view showing the medical device 10.

  As shown in FIGS. 1 to 4, the medical device 10 includes an introduction main body 11 to be inserted into the body as a main part. The introduction body 11 includes an attachment portion 12 to which the distal end portion 41 of the endoscope 40 can be attached, and an expandable / contractible bumper 30 for placement in the body in front of the attachment portion 12.

  The introduction main body 11 is provided with a protective material 20 for preventing the introduction main body 11 from penetrating when puncturing from outside the body toward the bumper 30 in a state where the bumper 30 is expanded and left in the body. ing. Further, a hollow portion 13 is provided in front of the bumper 30 in the introduction main body 11 to secure a lumen even when the bumper 30 contracts.

  More specifically, the introduction main body 11 is formed by leaving a front end portion and a rear end portion of a tube material made of a flexible material such as silicone rubber and notching the outer periphery between them in a predetermined range in the axial direction and the circumferential direction. Here, the rear end portion is the attachment portion 12 in which the distal end portion 41 of the endoscope 40 can be mounted inside the cylindrical shape, and the front end portion of the cylindrical portion is the hollow portion 13 as it is.

  The inner diameter of the mounting portion 12 is set in advance so that it can be easily attached and detached according to the outer diameter of the endoscope 40. Further, the front end portion surrounding the hollow portion 13 is partially cut away in the circumferential direction and opened in a slit shape. Such an open portion serves as an insertion portion 13a for passing a guide wire or the like as will be described later. Note that the front end surface of the front end portion is subjected to chamfering such as tapering in order to improve insertion into the body.

  The protective material 20 is provided on the lumen side of the arc-shaped cross section excluding the front end portion and the rear end portion of the introduction main body 11. The protective material 20 is made of a metal mesh material that is developed in a planar shape along the lumen side. Here, as the metal mesh material, a fine stainless steel mesh or the like is suitable, and the specific wire diameter and mesh size may be any size as long as it has a size and strength that the puncture needle cannot penetrate.

  The protective material 20 is preferably provided so as to be embedded near the surface layer rather than being attached to the surface on the lumen side. Specifically, it is conceivable to laminate the protective material 20 so as to cover the same material as the introduction main body 11. The protective material 20 is not limited to a metal mesh material, and may be composed of a rod or the like as long as it has a strength that can prevent penetration of the puncture needle.

  A balloon made of an elastically deformable material is provided as the bumper 30 at a position covering the protective material 20. The bumper 30 has a shape along the surface on the lumen side of the arc-shaped cross-section portion of the introduction main body 11 at the time of contraction, and is attached so as to cover the protective material 20. As a specific material of the bumper 30, silicone rubber excellent in stretchability is suitable, but is not limited thereto, and may be molded using polyurethane, natural rubber, or the like.

  The bumper 30 is desirably transparent so as not to obstruct the field of view of the endoscope 40. That is, the endoscope 40 attached to the mounting portion 12 performs observation through the inside of the bumper 30 when the bumper 30 is expanded. The peripheral edge of the bumper 30 is bonded to the surface side of the introduction main body 11 on the lumen side.

  The bumper 30 is disposed at a position that abuts a lens (not shown) at the distal end portion 41 of the endoscope 40 attached to the attachment portion 12 when the bumper 30 is inflated. More specifically, the position of the glue margin of the bumper 30 is the lens at the distal end portion 41 of the endoscope 40 attached to the mounting portion 12 when the bumper 30 is expanded with respect to the rear end edge 31 facing the mounting portion 12 side. It arrange | positions in the boundary thru | or the inside of the attaching part 12 so that it may contact | connect (not shown).

  The introduction main body 11 is provided with an inlet hole 14 so as to communicate with the inside of the bumper 30 defined by the inner surface of the bumper 30 and the inner surface of the arc-shaped cross section. The inlet hole 14 is opened at the rear end face of the introduction main body 11, and an inlet tube 15 for taking in and out gas or liquid for expanding and contracting the bumper 30 is connected to the opening. A connector 16 is connected to the proximal end side of the feeding tube 15.

  The material of the feeding tube 15 is not particularly limited as long as it has appropriate flexibility and strength, but silicone rubber or the like is suitable. The connector 16 is a member for connecting a syringe or the like for feeding gas or liquid for expanding and contracting the bumper 30, and includes a cock 18 that can open and close an internal flow path by rotating the handle 17. .

Next, the operation of the medical device 10 according to the present embodiment will be described.
According to the medical device 10, when the introduction body 11 is inserted into the body, the bumper 30 provided in the introduction body 11 is contracted, and the attachment portion 12 provided on the rear side of the bumper 30 is internally retracted. The endoscope 40 is attached. Thereby, the introduction main body 11 can be inserted to a desired position in the body while confirming the endoscope 40 image.

  Specifically, for example, as shown in FIG. 7, the endoscope 40 equipped with the medical device 10 is orally inserted into the cervical esophagus to reach the puncture site. Then, a physiological saline mixed with a contrast medium is injected from the connector 16 and the bumper 30 is inflated to be placed. In such a state, puncture directly from the body surface toward the bumper 30 with the puncture needle 50 while confirming the position of the bumper 30 with the image of the endoscope 40 or the ultrasonic (echo) image of the ultrasonic probe applied to the neck. To do.

  Since the introduction body 11 is provided with a protective material 20 that prevents penetration when puncturing, there is no risk of accidental puncturing of internal tissues such as the posterior wall of the esophagus, and changes such as vascular damage in the esophagus during puncture are also visible. Since the confirmation can be performed by the mirror 40, the safety can be further improved. In addition, according to the confirmation by the ultrasonic (echo) image, since the projection state of the bumper 30 and the protective material 20 is different, the orientation can be determined.

  When the bumper 30 ruptures after puncture, the esophagus collapses and closes the visual field, but since the hollow part 13 is in front of the bumper 30, the collapse of the esophagus can be prevented and a minimum lumen is secured. be able to. In addition, when inserted into the cervical esophagus orally as in the present embodiment, it is possible to avoid the possibility of nasal bleeding and to greatly reduce the patient's pain because it is not accompanied by a nasal operation.

  In addition, as shown in FIG. 6, the inflated bumper 30 is in contact with the lens at the distal end portion 41 of the endoscope 40, so that a clear visual field can be secured. Such a medical device 10 has a relatively simple configuration and can be manufactured at low cost. In particular, the protective material 20 is made of a metal mesh material developed in a planar shape on the lumen side of the arc-shaped cross section of the introduction main body 11, and can be reduced in manufacturing cost because it is inexpensive.

  In FIG. 7, after the puncture, the guide wire is placed in the esophagus through the guide wire in the lumen of the puncture needle 50. Here, when the guide wire is sufficiently placed in the esophagus, the endoscope 40 is removed together with the medical device 10. Since the hollow portion 13 of the medical device 10 has the insertion portion 13a, even if a guide wire or an indwelling catheter is inserted into the inner cavity of the medical device 10, particularly the hollow portion 13, it is easily in the radial direction from the axis. Can be removed.

  Thereafter, the fistula is expanded with a sheath with a dilator around the guide wire. When the sheath is indwelled, the catheter tip is positioned in the vestibular part of the stomach while inserting the catheter into the lumen and confirming under fluoroscopy. The above is the outline of percutaneous transesophageal gastric tube insertion (PTEG). In addition, the medical device 10 has various lumens including percutaneous endoscopic gastrostomy (PEG) by appropriately changing the size of the endoscope 40 to be mounted, the type of the bumper 30, and the like. It can be used as a medical device in organs.

8 and 9 show a second embodiment of the present invention.
In the present embodiment, the shape of the balloon that is the bumper 30 </ b> A is different from that of the bumper 30. That is, the bumper 30A does not swell only on one side on the lumen side of the arc-shaped cross section of the introduction main body 11, but in a spherical shape over the entire circumference of the introduction main body 11 in a state of covering not only the lumen side but also the outside. It is provided in a bulging shape.

  According to such a configuration, since the protective material 20A is located not at the end of the balloon that is the bumper 30A but at the center, it is easy to confirm the position of the protective material 20A even in an ultrasonic (echo) image. Moreover, since the protective material 20A is surrounded by the balloon in the entire circumferential direction, the center of the balloon can be reliably punctured toward the protective material 20A.

  Also, the shape of the protective material 20A is different from the protective material 20, and the protective material 20A is formed so as to spread in an elliptical shape. Such a protective material 20A is excellent from the viewpoint of preventing penetration when puncturing if the area is increased as much as possible, but it is preferable to set it to an appropriate size and shape in order to maintain flexibility.

  Further, the introduction main body 11 is provided with a metal bar 21 along the center of the protective material 20A. The bar 21 is a means for facilitating confirmation of the orientation of the introduction main body 11 and the bumper 30A under an ultrasonic (echo) image, and can be made clear when puncturing. The bar 21 according to the present embodiment is embedded in the introduction main body 11 along the center of the protective material 20A. However, the specific thickness and length of the protective material 20A, the position where the protective material 20A is disposed, or the like may be appropriately determined. good. In addition, the same code | symbol is attached | subjected to the site | part of the same kind as 1st Embodiment, and the overlapping description is abbreviate | omitted.

  Although the embodiments of the present invention have been described with reference to the drawings, the specific configuration is not limited to the above-described embodiments, and there are changes and additions within the scope not departing from the gist of the present invention. Are also included in the present invention. For example, the bumper 30 is configured such that linear members, not balloons, are arranged radially around the axis and expanded or contracted by approaching or separating along the axis or using a shape memory material. May be.

  As another configuration, the introduction main body 11 may be formed using the tube material as it is without cutting out a part of the tube material. In this case, the rear end portion of the tube material is the mounting portion 12 in which the distal end portion 41 of the endoscope 40 can be mounted, and the inside of the front end portion of the tube material is the hollow portion 13 as it is. The protective material 20, 20A is provided along the outer periphery of the tube material, and a balloon made of an elastically deformable material is provided as the bumper 30A over the entire circumferential direction at a position covering the protective material 20, 20A. It can also be configured.

  The medical device according to the present invention is a percutaneous transesophageal gastrostomy (PTEG) or percutaneous endoscopic gastrostomy (PEG) as a medical device used for puncture from outside the body while indwelling in the body. ) And can be used widely.

DESCRIPTION OF SYMBOLS 10 ... Medical device 11 ... Introduction main body 12 ... Mounting part 13 ... Hollow part 13a ... Insertion part 14 ... Feeding hole 15 ... Feeding tube 16 ... Connector 17 ... Handle 18 ... Cock 20 ... Protective material 20A ... Protective material 21 ... Bar 30 ... Bumper 30A ... Bumper 31 ... Rear edge 40 ... Endoscope 41 ... Tip 50 ... Puncture needle

Claims (7)

In a medical device including an introduction body to be inserted into the body, an attachment portion to which the distal end portion of the endoscope can be attached, and an expandable / contractible bumper for placement in the body in front of the attachment portion.
A protective material that prevents the introduction body from penetrating when puncturing from outside the body toward the bumper in a state where the bumper is expanded and left in the body in the introduction body ,
A medical device comprising: a hollow portion for securing a lumen even when the bumper contracts in front of the bumper in the introduction main body .   The medical device according to claim 1, wherein the protective material is made of a metal mesh material developed in a planar shape at a predetermined location of the introduction main body. The medical device of claim 1 or 2, characterized in that to release the part of the circumferential direction surrounding the hollow portion of the inlet body in a slit shape. The introduction body, which during the outer periphery leaving a front end and a rear end portion of the tubing of flexible material is him notch in a predetermined range in the axial direction and circumferential direction,
The rear end portion becomes the attachment portion capable of mounting the distal end portion of the endoscope inside a cylindrical shape,
As for the front end part, the inside of a cylinder becomes the hollow part as it is,
The protective material is provided on the lumen side of the arc-shaped cross section excluding the front end portion and the rear end portion, and a balloon made of an elastically deformable material is provided as the bumper at a position overlapping the protective material. The medical device according to claim 1, 2, or 3. The balloon is made of a transparent material, according to claim 4, characterized in that disposed in a position in which it contacts the lens on the distal end side of the endoscope mounted on the mounting portion when inflated said balloon Medical device. The balloon, in claim 4 or 5, characterized in that the provided elastically deformable shape over the entire circumferential direction in a state where the outside cover not the luminal side only of arcuate cross section the tube material The medical device described. The medical device according to claim 1, 2, 3, 4, 5 or 6 , wherein the introduction main body is provided with a metal bar for confirming the orientation of the introduction main body under an ultrasonic image. Device.

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