JP6017345B2 - Fixtures and medical devices - Google Patents

Description

  The present invention relates to a fixture for fixing a medical instrument to a tissue and a medical device including the fixture.

  2. Description of the Related Art Conventionally, a fixing tool that is attached to a medical device in order to fix the medical device such as a cannula to a tissue in the body is known (for example, see Patent Document 1). The fixing device described in Patent Document 1 includes a sleeve mounted on the outer peripheral surface of a medical device and two balloons positioned around the sleeve, and the medical device is formed in a hole formed through a tissue such as an abdominal wall. The medical device is fixed to the tissue by sandwiching the tissue in the thickness direction by two balloons inserted and expanded.

JP 2005-524491 A

  However, the peripheral portion of the hole in the tissue is fragile and fragile due to the strong contact or rubbing during the incision operation or the insertion operation of the medical instrument. In the fixture described in Patent Document 1, since the balloon is in strong contact with the fragile peripheral portion, the structure of the tissue in the peripheral portion is further disturbed and becomes more fragile. In particular, in the case of a thin and fragile tissue such as the pericardium compared to a relatively thick and sturdy tissue such as the peritoneum, the tissue shape cannot be maintained or the pores may expand. There is a problem that it is difficult to exert a sufficient fixing force of the medical device.

  The present invention has been made in view of the above-described circumstances, and includes a fixture that can stably fix a medical instrument to a tissue while protecting a cut edge portion of the tissue that has become brittle due to incision. An object is to provide a medical device.

In order to achieve the above object, the present invention provides the following means.
The present invention relates to a fixing device attached to the medical device for fixing an elongated medical device to be inserted into a body to tissue in the body, and the medical device is inserted into an outer peripheral surface of the medical device. A cylindrical main body to be attached , wherein at least part of the longitudinal direction is formed so that a plurality of pleats extending outward in the radial direction can be folded in a bellows shape aligned in the longitudinal direction ; The pleats are arranged on the outer peripheral surface at intervals in the longitudinal direction, and include two gripping members for gripping the tissue in the longitudinal direction, and the two gripping members are in contact with the longitudinal direction. Each having a contact portion that is relatively movable in the longitudinal direction between a position where the contact portion and a position separated from each other, and the contact portions are located at a position spaced radially outward from the outer peripheral surface of the main body. Contact in the longitudinal direction To provide a fixture.

According to the present invention, by inserting a medical device equipped with a main body into a hole penetrating the tissue, disposing the gripping members on both sides of the tissue, and gripping the tissue with the contact portions of the two gripping members The medical device can be fixed to the tissue.
In this case, the tissue is not in contact with the outer peripheral surface of the body adjacent to the outer peripheral surface of the main body, but at a position away from the outer peripheral surface of the main body and not directly affected by the incision operation or the insertion operation of the medical device. It is gripped by the part. Accordingly, the medical instrument can be stably fixed to the tissue while protecting the cut edge portion of the tissue that has become brittle due to the incision.

In the above invention, the two gripping members have a shape that spreads outward in the radial direction from the outer peripheral surface of the main body, and the contact portion is provided at a position facing the longitudinal direction of the gripping member. It may be done.
By doing in this way, the space enclosed by the outer peripheral surface of a main body, two holding members, and a contact part is ensured in the area | region adjacent to the outer peripheral surface of a main body. Thereby, the cut edge part of a structure | tissue can be protected more reliably from contact with the surrounding member.

Moreover, in the said invention, the said holding member may be deformable between the shape along the said outer peripheral surface of the said main body, and the shape extended to the said radial direction outward from the said outer peripheral surface.
By doing in this way, until a main body is inserted in the hole of a structure | tissue, insertability can be improved by making a holding member into the shape along the outer peripheral surface of a main body.

Moreover, in the reference example of the said invention, the said holding member is a balloon provided in the said outer peripheral surface of the said main body, You may provide the fluid supply means which supplies a fluid to the said balloon.
By doing in this way, a balloon can be expanded by simple operation which only supplies a fluid to a balloon with a fluid supply means.

Moreover, in the reference example of the said invention, both the said holding members are the said balloons, and the inside of these two said balloons may mutually communicate.
In this way, two balloons can be expanded simultaneously using a common fluid supply means.

Moreover, in the reference example of the said invention, the said contact part may be provided with the convex member which is provided in the outer surface of the said balloon and protrudes from this outer surface.
In this way, the tissue can be gripped more firmly.

Further, at least a part of the main body in the longitudinal direction is formed such that a plurality of pleats extending outward in the radial direction can be folded in a bellows shape aligned in the longitudinal direction, and the gripping member comprises the pleats in the above invention, before SL contact portion, at a position where the body is arranged at intervals in the radially outward from the position of the valley of the corrugation when folded like bellows, the outer periphery of the main body It may be provided so as to protrude radially outward from the surface.
By doing this, the tissue is sandwiched between two folds adjacent to the longitudinal direction of the main body by deforming the main body into a bellows shape with the tip of the main body inserted into the hole of the tissue. The tissue is grasped by the contact portion protruding toward the tissue. In this way, by forming a gripping member by deforming a part of the main body, the number of constituent members can be reduced and a simple and small-diameter structure can be obtained.

Moreover, in the said invention, you may provide the latching | locking part which is provided in the front-end | tip of the said main body and protrudes inward in a radial direction from the inner surface of the said main body.
Thus, when the distal end portion of the medical instrument is inserted into the main body and the main body is attached to the medical instrument, the medical instrument is inserted to a position where the distal end of the medical instrument hits the locking portion. And the relative position in the longitudinal direction of the main body can be easily positioned.

  Moreover, this invention provides a medical device provided with the fixing tool in any one of the said, and the medical instrument which is inserted in the said main body of this fixing tool, and the said fixing tool is attached to an outer peripheral surface.

  According to the present invention, there is an effect that it is possible to fix to a tissue while protecting a cut edge of the tissue that has become brittle by incision.

It is the (a) longitudinal cross-sectional view which shows the partial structure in the contracted state of the balloon of the fixing tool and medical device which concern on reference embodiment of this invention, and (b) The front view seen from the front end side. It is the (a) longitudinal cross-sectional view which shows the structure in the expansion state of the balloon of the medical device of FIG. 1, and (b) The front view seen from the front end side. (A), (b), (c) It is a figure explaining operation | movement and the usage method of the medical device of FIG. It is a longitudinal cross-sectional view which shows the structure of the 1st modification of the fixing tool of FIG. It is a longitudinal cross-sectional view which shows the structure of the 2nd modification of the fixing tool of FIG. It is a longitudinal cross-sectional view which shows the structure of the 3rd modification of the fixing tool of FIG. It is a longitudinal cross-sectional view which shows the structure of the 4th modification of the fixing tool of FIG. It is a longitudinal cross-sectional view which shows the partial structure of the fixing tool and medical device which concern on one Embodiment of this invention. (A)-(d) It is sectional drawing which shows the position and shape of four types of groove | channels formed in the main body of the fixing tool of FIG. (A)-(c) It is a figure explaining the operation | movement and usage method of the medical device of FIG. (A), (b) It is a figure explaining operation | movement and the usage method of the medical device of FIG.

[ Reference embodiment]
Hereinafter, a fixture 1 according to a reference embodiment of the present invention and a medical device 100 including the same will be described with reference to FIGS. 1 to 7.
As shown in FIG. 1, the medical device 100 according to this embodiment includes a sheath (medical instrument) 50 into which another medical instrument such as an endoscope or a treatment instrument is inserted, and a distal end portion of the sheath 50. And a fixing tool 1 to be mounted.

The sheath 50 has an elongated cylindrical shape with both ends opened, and has flexibility that allows insertion into the living body along the tissue shape.
The fixture 1 includes a cylindrical main body 2 having both ends open, two balloons (gripping members) 3 and 4 provided on the outer peripheral surface of the main body 2, and a tube ( Fluid supply means) 5 and a stopper (locking portion) 6 provided at the tip of the main body 2. The main body 2, the balloons 3, 4 and the stopper 6 are made of a material having biocompatibility and flexibility such as silicone rubber.

  The main body 2 has an inner diameter that is substantially the same as the outer diameter of the sheath 50, and the inner peripheral surface of the main body 2 is sufficiently larger than the outer peripheral surface of the sheath 50 when the sheath 50 is inserted into the main body 2. The close contact allows the main body 2 to be attached to the outer peripheral surface of the sheath 50 sufficiently stably.

  The two balloons 3 and 4 have an annular shape extending over the entire circumference of the outer peripheral surface of the main body 2. The two balloons 3 and 4 are arranged in the longitudinal direction of the main body 2 with an interval larger than the thickness dimension of the tissue (the pericardium X in the example described later) that fixes the sheath 5. On the outer surface of the first balloon 3 located on the distal end side of the main body 2, a convex member (contact portion) 7 is provided which is made of an annular member extending over the entire circumference and protrudes from the outer surface of the first balloon 3. Yes. The convex member 7 is a member made of an elastic material such as an O-ring that can expand and contract in the circumferential direction in accordance with the expansion and contraction of the first balloon 3. The convex member 7 includes a part (contact portion) of the outer surface of the second balloon 4 located on the proximal end side and the main body when both the balloons 3 and 4 are expanded to a sufficient diameter as will be described later. 2 is provided at a position in contact with the longitudinal direction.

  The first balloon 3 and the second balloon 4 communicate with each other in a part in the circumferential direction. The distal end of the tube 5 is connected to the second balloon 4 located on the proximal end side, and a connector 5 a that can be connected to the syringe 11 is provided at the proximal end of the tube 5. By connecting the syringe 11 to the connector 5a and supplying fluid into the tube 5, as shown in FIGS. 2 (a) and 2 (b), the two balloons 3 and 4 are inflated simultaneously. Yes. Reference numeral 5b indicates a valve for opening and closing the tube 5. By closing the valve 5b after supplying fluid to the balloons 3 and 4, the balloons 3 and 4 can be maintained in an inflated state.

  At this time, the two balloons 3 and 4 inflated in a substantially spherical shape up to a sufficient diameter are spaced from the outer peripheral surface of the main body 2 radially outward via the convex member 7 in the longitudinal direction of the main body 2. They come into contact with each other. A space S surrounded by the outer surfaces of the two balloons 3 and 4 and the outer peripheral surface of the main body 2 is formed at a position adjacent to the outer peripheral surface of the main body 2.

  The stopper 6 has a flange shape protruding inward in the radial direction from the inner peripheral surface of the main body 2. When the distal end of the sheath 50 inserted into the main body 2 abuts against the stopper 6, the relative position in the longitudinal direction between the main body 2 and the sheath 50 is positioned.

Next, the operation of the medical device 100 configured as described above will be described by taking as an example the case where other medical instruments such as an endoscope and a treatment tool are guided from outside the body to the pericardium X.
First, the sheath 50 with the fixture 1 attached to the distal end is inserted into the living body with both balloons 3 and 4 contracted, and the distal end of the sheath 50 is moved as shown in FIG. Then, the pericardium X is inserted into a hole Y that has been formed through the pericardium X in advance, and is placed in the pericardium X. At this time, the sheath 50 is positioned with respect to the pericardium X so that the first balloon 3 is disposed in the pericardium X and the second balloon 4 is disposed outside the pericardium X.

Next, by supplying a fluid into the tube 5 using the syringe 11, the first balloon 3 and the second balloon 4 are inflated to a sufficient diameter as shown in FIG. 3B. Thereby, as shown in FIG. 3C, the pericardium X is sandwiched and gripped by the outer surface of the second balloon 4 and the convex member 7 in the thickness direction, and the distal ends of the fixture 1 and the sheath 50. Is fixed to the pericardium X.
By the above procedure, a route isolated from the tissue from outside the body to the pericardium X is secured in the sheath 50. The operator can easily insert / remove other medical instruments between the outside of the body and the pericardium X through the sheath 50.

  In this case, the edge portion of the hole Y formed in the pericardium X is fragile because the structure of the tissue is disturbed by the incision operation and the insertion operation of the medical device 100. According to the present embodiment, the fragile cut edge portion is located in the space S surrounded by the outer surfaces of the two balloons 3 and 4 and the outer peripheral surface of the main body 2, so that contact with surrounding members and Protected from the action of external forces. Thereby, there exists an advantage that it can prevent that the incision part of the pericardium X which has become weak is received further. Further, since the pericardium X is gripped by the second balloon 4 and the convex member 7 at a position away from the outer peripheral surface of the sheath 50 radially outward, that is, at a healthy position rather than a fragile position. There is an advantage that a sufficient gripping force can be obtained and the sheath 50 can be stably fixed to the pericardium X.

Next, a modified example of the fixture 1 according to this embodiment will be described.
(First modification)
As shown in FIG. 4, in the fixture 1-1 according to the first modification of the present embodiment, the convex member 7 is provided on the outer surface of the second balloon 4 instead of the first balloon 3. ing.
Thus, by providing the convex member 7 at the position arranged outside the pericardium X, the insertion property of the fixture 1 into the body can be improved.

(Second modification)
As shown in FIG. 5, the fixture 1-2 according to the second modification of the present embodiment omits the convex member 7 and expands the first balloon 3 and the second balloon that have expanded to a sufficient diameter. The pericardium X is gripped by a portion (contact portion) of the outer surface of 4 that contacts the longitudinal direction of the main body 2.
By doing in this way, the insertion property to the body of the fixing tool 1 can further be improved.

(Third Modification)
As shown in FIG. 6, the fixture 1-3 according to the third modified example of the present embodiment replaces the second balloon 4 and has a flange portion that protrudes radially outward from the outer peripheral surface of the main body 2. (Gripping member) 12 is provided. When the first balloon 3 is inflated to a sufficient diameter, as shown by a two-dot chain line, the convex member 7 and a part (contact portion) of the front end side surface of the flange portion 12 come into contact with each other. It has become.
By doing in this way, the supply amount of the fluid required for the inflation of the balloon 3 can be reduced, and the operation can be facilitated.

(Fourth modification)
In the fixture 1-4 according to the fourth modification of the present embodiment, the stopper 6 provided at the tip of the main body 2 is omitted as shown in FIG.
By doing in this way, the position of the balloons 3 and 4 with respect to the sheath 50 can be arbitrarily set by arbitrarily changing the relative position of the main body 2 and the sheath 50 in the longitudinal direction.

[ One Embodiment of the Present Invention ]
Next, the fixture 20 and the medical device 200 according to an embodiment of the present invention will be described with reference to FIGS. In the present embodiment, the configuration different from the reference embodiment will be mainly described, and the configuration common to the reference embodiment will be denoted by the same reference numeral and the description thereof will be omitted.
Medical device 200 according to this embodiment, the body 21 of the fixture 20, the grooves 21a formed on the outer peripheral surface, 21b, 21c, in that it is foldable structure in a bellows shape by 21d, and referential embodiment Is different.

  As shown in FIG. 8, the main body 21 has a dimension in the longitudinal direction substantially the same as the dimension in the longitudinal direction of the sheath 50, and is mounted over the entire length from the distal end to the proximal end of the sheath 50. The main body 21 and the sheath 50 inserted into the main body 21 are provided so as to be relatively movable in the longitudinal direction.

  As shown in FIGS. 9A to 9D, four types of wedge-shaped grooves 21a, 21b, 21c, and 21d are formed at the distal end of the main body 21 at intervals in the longitudinal direction. Yes. In FIG. 8, the arrows A, B, C, and D form the grooves 21a, 21b, 21c, and 21d shown in FIGS. 9 (a), (b), (c), and (d), respectively. Indicates the position.

  The first groove 21 a shown in FIG. 9A is a relatively deep groove formed on the inner peripheral surface of the main body 21 over the entire circumference. The second groove 21b shown in FIG. 9B is a relatively deep groove formed on the outer peripheral surface of the main body 21 over the entire circumference. The third groove 21c shown in FIG. 9C is a groove formed on the inner peripheral surface of the main body 21 over the entire circumference and shallower than the first groove 21a. The fourth groove 21d shown in FIG. 9D is a groove formed on the outer peripheral surface of the main body 21 over the entire circumference and shallower than the second groove 21b.

  When a longitudinal compressive force is applied to the main body 21 in which such grooves 21a, 21b, 21c, and 21d are formed, it is shown in FIGS. 10 (a) to 10 (c) and FIGS. 11 (a) and 11 (b). Thus, the front-end | tip part of the main body 21 is folded in the shape of a bellows. At this time, in the process of folding the main body 21, first, the main body 21 is folded at the positions of the relatively deep first groove 21 a and second groove 21 b, thereby, as shown in FIG. A claw portion (contact portion) 9 protruding outward in the radial direction 21 is formed. When the compressive force is further applied, the main body 21 is then folded at the positions of the relatively shallow third groove 21c and fourth groove 21d, and as shown in FIG. A part of the direction protrudes outward in the radial direction to form a fold (gripping member) 10.

  Here, the interval between the adjacent fourth grooves 21 d corresponding to the interval between the adjacent pleat portions 10 is set to be larger than the thickness of the pericardium X. Further, in a state of being folded into a bellows shape, the claw portion 9 is arranged on the surface on the proximal end side of the pleat portion 10, and the distal end of the claw portion 9 and the pleat portion adjacent to the proximal end side of the claw portion 9 The positions of the four types of grooves 21a, 21b, 21c, and 21d are appropriately set so that a part (contact portion) of the surface on the tip side of 10 is in contact.

Such a main body 21 is configured by coating a skeleton made of a material having high strength such as polyacetal with a soft material such as silicone rubber.
A flange-like stopper 61 that protrudes radially outward from the outer peripheral surface is provided at the distal end of the sheath 50, and the longitudinal direction of the main body 21 and the sheath 50 is abutted against the stopper 61. Are positioned relative to each other.

Next, as for the operation of the medical device 200 configured as described above, as in the reference embodiment, another medical instrument such as an endoscope or a treatment tool is guided from outside the body to the pericardium X as an example. I will explain.
First, the sheath 50 having the outer peripheral surface mounted with the fixture 20 is inserted into the living body, and the distal end of the sheath 50 is inserted into the hole Y of the pericardium X as shown in FIG. Arrange in the membrane X. At this time, the sheath 50 is positioned so that at least the position of the first groove 21a on the most distal side is disposed in the pericardium X.

Next, the base end portion of the main body 21 arranged outside the body is pushed toward the distal end side and moved with respect to the sheath 50, so that FIGS. 10 (b), 10 (c) and FIGS. 11 (a), 11 (b). As shown, the tip of the body 21 is folded into a bellows shape. As a result, as shown in FIG. 11B, the pericardium X is sandwiched in the thickness direction by the claw portion 9 disposed in the pericardium X and the pleat portion 10 disposed outside the pericardium X. Then, the distal end portions of the fixing tool 20 and the sheath 50 are fixed to the pericardium X.
By the above procedure, a route isolated from the tissue from outside the body to the pericardium X is secured in the sheath 50. The operator can easily insert / remove other medical instruments between the outside of the body and the pericardium X through the sheath 50.

  In this case, according to the present embodiment, the cut edge portion of the hole Y of the pericardium X which is fragile is surrounded by the two pleat portions 10 adjacent to each other in the longitudinal direction, the outer peripheral surface of the main body 21 and the claw portion 9. Therefore, it is protected from contact with surrounding members and the action of external force. Thereby, there exists an advantage that it can prevent that the incision part of the pericardium X which has become weak is received further. Further, since the pericardium X is gripped by the claw portion 9 and the pleat portion 10 at a position away from the outer peripheral surface of the sheath 50 radially outward, that is, at a healthy position rather than a fragile position, Advantageous gripping force can be obtained and the sheath 50 can be stably fixed to the pericardium X.

Further, according to the present embodiment, since the members disposed outside the main body 21 such as the balloons 3 and 4 and the tube 5 of the reference embodiment are unnecessary, the structure has a small diameter and a relatively smooth outer surface. There is an advantage that the insertion into the body can be improved. Further, since the pericardium X can be grasped at a plurality of positions in the longitudinal direction of the main body 21, there is an advantage that the positioning accuracy of the sheath 50 in the longitudinal direction with respect to the pericardium X can be relaxed.

In the reference embodiment and the embodiment of the present invention described above, the sheath 50 is taken as an example of a medical instrument to which the fixtures 1 and 20 are attached. However, the fixtures 1 and 20 are inserted into the body. The present invention can also be applied to endoscopes and other medical instruments having an elongated insertion portion.

1,1-1,1-2,1-3,1-4,20 fixture 2,21 body 3,4 balloon (gripping member)
5 Tube (fluid supply means)
5a connector 5b valve 6,61 stopper (locking part)
7 Convex member (contact part)
9 Nail part (contact part)
10 pleats (gripping member)
11 Syringe 12 Flange (Gripping member)
21a, 21b, 21c, 21d Groove 50 Sheath (medical instrument)
100,200 medical device

Claims (6)

A fixing device attached to the medical device for fixing an elongated medical device to be inserted into the body to tissue in the body,
A cylindrical main body into which the medical instrument is inserted and attached to the outer peripheral surface of the medical instrument, wherein at least a part of the longitudinal direction is a bellows shape in which a plurality of pleats extending radially outward are arranged in the longitudinal direction A body formed to be foldable into ,
Comprising the pleats arranged at intervals in the longitudinal direction on the outer peripheral surface of the main body, and comprising two grasping members for grasping the tissue sandwiched in the longitudinal direction,
The two gripping members each have a contact portion that is relatively movable in the longitudinal direction between a position in contact with the longitudinal direction and a position separated from each other;
A fixture in which these contact portions contact each other in the longitudinal direction at positions spaced radially outward from the outer peripheral surface of the main body. Before SL contact portion, fixture of claim 1 which are mutually arranged in a position facing the longitudinal direction of the gripping member.   The fixture according to claim 2, wherein the gripping member is deformable between a shape along the outer peripheral surface of the main body and a shape extending outward in the radial direction from the outer peripheral surface. Before SL contact portion, at a position where the body is arranged at intervals in the radially outward from the position of the valley of the corrugation when folded like bellows, radially outward from the outer peripheral surface of said body fixture according to any of claims 1 to 3, is provided so as to protrude toward. The fixture according to any one of claims 1 to 4 ,
A medical device comprising: a medical instrument that is inserted into the main body of the fixture and to which the fixture is attached to an outer peripheral surface. The fixture according to claim 5, further comprising a locking portion provided at a distal end of the medical device and protruding radially outward from an outer surface of the medical device.

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