JP4847774B2 - Endoscope - Google Patents

Description

  The present invention relates to an endoscope having an injection needle for injecting a biocompatible injection agent into a body tissue.

  Conventionally, in the treatment of urinary incontinence, there is a method of increasing a fusion pressure to the urethra by injecting a biocompatible material such as collagen into a body tissue around the urethra.

  This method includes transperineal injection and transurethral direct injection, but the latter is easier to inject into the correct location and requires less injection than the former. Recently, it has become mainstream.

  In the transurethral injection method, a transurethral endoscope in which an injection needle is set is used and inserted through the urethra from the outer urethral opening until the tip reaches the bladder. Then, the infusate is allowed to flow out from the tip of the infusion needle, the air in the lumen of the infusion needle is evacuated, the infusion needle is returned, and the endoscope tip is retracted from the bladder neck by a predetermined retraction length (usually about 1.5 cm to 2 Retreat by about .0 cm). This vicinity is exactly the vicinity of the extraurethral sphincter and the injection position of the injection. In puncture, the needle is advanced under the urethral mucosa, and further, the angle with the urethral mucosa is reduced, and the needle is advanced just to the distal end of the bladder neck to inject the injection. The amount to be injected is determined by the degree of swelling of the urethral mucosa under direct viewing.

  However, there are generally two puncture directions of the injection needle in the vicinity of the extraurethral sphincter, the so-called 4 o'clock and 8 o'clock directions, and the puncture angle is about ± 45 degrees with respect to the horizontal direction. Therefore, the endoscope is rotated from the posture state at the time of insertion and pressed in the direction perpendicular to the axis.

  For this reason, when viewing with the eyepiece at the rear end of the endoscope, the urinary bulge proximate from the bladder neck may not always be confirmed because it is displaced from the state of being directly directed to the bladder neck. If the puncture angle of the injection needle is reduced to ensure a visual field, the injection needle cannot be advanced under the urethral mucosa, and the urethral mucosa may be cut off by the blade surface of the injection needle. Injecting the infusate may tear the urethral mucosa and leak the infusate from the crack.

  Here, “the puncture angle is shallow” means that the angle formed between the axis of the injection needle and the puncture surface is small.

  Side effects due to injection include postoperative urination disorder and urinary retention that are thought to be caused by the injection site, injection volume, and leakage, which are often transient, with the former being 18.6% and the latter being 7.1% (see Urology Surgery Vol.7, pp. 821-831, 1994) has been reported, and other cases such as hematuria, micturition pain, and bladder irritation are rare Therefore, considerable care and certainty are required for injection with an injection needle.

  In particular, leakage (backflow) after injection is greatly reduced in therapeutic effect due to the quantitative reduction of the infusate, and various proposals have heretofore been made to prevent this.

  For example, Patent Document 1 below proposes using a non-coring needle so that the needle hole position can be recognized from the outside in order to prevent leakage from the punctured needle path.

  Patent Documents 2 and 3 below propose that the inclusion membrane is incorporated into the outer tube in a squeezed state, and the injection is not injected directly into the body tissue but is injected into the inclusion membrane.

However, the use of non-coring needle, be sealed infusate inclusion membrane therein, or precisely punctures a predetermined injection site and injection needle, the squirrel Ru operation punctured at a predetermined puncture angle The fact is that it is not easy.
Japanese Patent No. 3630461 (see paragraph numbers “0010” to “0013”, etc.) Japanese Patent No. 2652164 (refer to claims, FIG. 3 etc.) Japanese Patent No. 2649226 (refer to claims, FIG. 10 etc.)

  The present invention has been made to solve the above-described problems. When a biocompatible injection agent is injected into a body tissue using an injection needle, the injection needle is accurately controlled and a predetermined puncture angle is set at a predetermined injection location. It is an object of the present invention to provide an endoscope that can be punctured with a needle and can prevent leakage after injection.

An endoscope of the present invention that achieves the above object is an endoscope in which an injection needle for injecting a biocompatible injection agent into a body tissue is provided in a main body to be inserted into a body cavity, and the main body has three lumens. In these lumens, the injection needle provided so as to be able to protrude and retract in the axial direction from the distal end of the main body, and the uneven distribution means for unevenly distributing the distal end portion of the main body in a direction intersecting the axis of the main body , In order to move the main body to the injection position of the infusate in the body cavity, a positioning balloon catheter that is pushed out from the distal direction of the main body and can be fixed in the bladder is provided, and the uneven distribution means includes the It is provided at a position facing the lumen through which the injection needle is inserted with respect to the central axis of the main body .

  In the present invention, since the tip position of the main body in which the injection needle can be moved in and out in the axial direction can be controlled to be displaced in the direction intersecting the axis by the unevenly distributed means, the body tissue near the puncture position is distorted and The angle can be increased, the puncture position of the injection needle can be accurately controlled, and the injection needle can be advanced to the optimal injection location.

  In particular, if the uneven distribution means is constituted by a balloon that can expand and contract, it becomes easy to control the amount of distortion of the body tissue by adjusting the force for expanding and contracting the balloon, so that the tip position of the body can be adjusted and the puncture angle can be adjusted A larger size enables more accurate puncture.

  The uneven distribution means is not limited to the balloon, and may be constituted by an elastic member as long as it can protrude from the tip of the main body. The elastic member includes, for example, a spring or an elastomer. In any case, if the protruding amount is controlled by the control means from the outside of the main body, the same effect as that of the balloon can be exhibited.

In addition, if the uneven distribution means is provided at a position opposite to the lumen through which the injection needle is inserted with respect to the central axis of the main body, the amount of displacement of the main body tip due to the uneven distribution means immediately affects the position displacement of the injection needle. The puncture angle of the needle can be increased, the puncture operation is further facilitated, and the procedure can be performed smoothly. In addition, a positioning balloon that is pushed out from the tip of the main body inserted into the bladder and can be fixed in the bladder is provided. it can.

  Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.

  1 is a schematic perspective view showing an endoscope according to an embodiment of the present invention, FIG. 2 is a sectional view taken along line 2-2 in FIG. 1, FIG. 3 is a sectional view taken along line 3-3 in FIG. 4 is a cross-sectional view taken along line 4-4 of FIG.

  In this embodiment, an endoscope is used for the treatment of urinary incontinence. The endoscope is inserted into the urethra or ureter, and the biocompatible injection is placed around the proximal urethra adjacent to the extraurethral sphincter or adjacent to the ureteral opening. Used for injection into body tissue.

  As shown in FIG. 1, the endoscope N of the present embodiment includes a long tubular main body 1, an operation unit 3 provided via a bridge unit 2 connected to the rear end of the main body 1, and an operation An eyepiece 4 provided at the rear end of the unit 3, and the operation unit 3 is connected to the light connector 5 projecting upward to introduce light from the light source and the bridge unit 2. An operating conduit 6 is provided.

  Further details will be described. First, as shown in FIG. 2, the main body 1 has a sheath 10 which is a portion to be inserted into the urethra or ureter for treatment and has an open end. The sheath 10 is not particularly limited, but when the main body 1 is made thinner and relatively flexible, it is preferably a thin-layer tube. Examples of the material thereof include polyimide, polyurethane, polyethylene, Tetrafluoroethylene or the like can be used, and a SUS material or the like can be used when the material is not flexible and rigid.

  Inside the sheath 10, three lumens 11, 12, 13, a light guide 30 and an image guide 31 are provided over substantially the entire length in the axial direction.

  First, regarding the lumen, the first lumen 11 on the right side of FIG. 2 is a needle lumen, and as shown in FIG. 4, an infusion catheter 14 provided with an infusion needle H at the tip is inserted. . The infusion catheter 14 is guided to the outside through the first lumen 11 and the operation conduit 6, and an infusion means (not shown) for injecting a biocompatible infusate is connected to the outer end portion. Note that any injection means may be used, and specifically, a syringe pump or the like is used. Further, the infusion catheter 14 is moved forward and backward in the axial direction within the first lumen 11 by operating from the outside, and the infusion needle H provided at the distal end can be moved in and out from the distal end of the sheath 10. .

  Here, the injection needle H may use either a coring needle or a non-coring needle in this embodiment, but a biocompatible injection agent such as collagen injected by the injection needle H is relatively Since it has viscosity, in order to inject it smoothly, it preferably has a certain inner diameter. For example, the injection needle H preferably has an inner diameter of about 0.5 mm to 1.5 mm. Further, the inner diameter of the infusion catheter 14 is preferably about 0.7 mm to 2.5 mm and is tapered.

  The second lumen 12 on the left side in the figure is a lumen for inflating the uneven distribution means 15 that is an important component of the endoscope N according to the present embodiment.

  The uneven distribution means 15 distorts the body tissue in the vicinity of the puncture position so that the injection needle H can be punctured at a deep puncture angle, increases the puncture angle with respect to the puncture surface, and accurately controls the puncture position of the injection needle H. The injection needle H can be advanced to the optimal injection location.

  As shown in FIG. 4, the uneven distribution means 15 of the present embodiment includes the uneven distribution balloon 16 provided on the outer surface of the distal end side portion of the sheath 10 and pressurization for introducing fluid pressure into the uneven distribution balloon 16. It comprises means 17 (see FIG. 1) and control means 18 (see FIG. 1) for controlling the pressurizing means 17. The unevenly distributed balloon 16 communicates with a port 21 provided on the base side of the second lumen 12 and the operation conduit 6 through a through hole 19 provided in the sheath 10. The pressurizing means 17 and the control means 18 are connected to the outer end portion of the port 21.

  As the material for the unevenly distributed balloon 16, a material having a low elastic modulus and a large elongation, such as silicon, polyurethane or styrene elastomer, is preferably used. The reason is that there are few steps with the outer surface of the sheath 10 at the time of contraction, and it can be protruded largely outside the sheath 10 at the time of expansion.

  For example, a syringe pump or a roller pump is used as the pressurizing means 17, and a gas such as air or a liquid such as physiological saline is supplied from the port 21 through the second lumen 12 to the through hole 19, The uneven distribution balloon 16 is inflated. The control means 18 controls the operation of a syringe pump, a roller pump, or the like so that fluid pressure is smoothly introduced. When manually operating the syringe pump that is the pressurizing means 17, the control means 18 is not necessarily provided.

  The unevenly-distributed balloon 16 that has been inflated under pressure largely protrudes to the outside of the sheath 10 and displaces the distal end of the sheath 10 by pressurizing the inner wall surface of the body cavity, thereby distorting the body tissue near the puncture position.

  Furthermore, in this embodiment, in order to efficiently displace the infusion catheter 14 by the unevenly distributed balloon 16, the position of the second lumen 12 with respect to the first lumen 11 is set with respect to the central axis of the sheath 10 or the main body 1. It is considered as an opposing position. In this way, the amount of expansion when the unevenly distributed balloon 16 is inflated appears as the amount of displacement of the distal end portion of the sheath 10 as it is, and the position of the distal end portion of the sheath 10, that is, provided on the infusion catheter 14. The position of the injection needle H can be displaced very smoothly. However, the position of the second lumen 12 with respect to the first lumen 11 is not necessarily limited to the position opposite to the central axis (a position orthogonal), and the efficiency is reduced, but the crossing angle may be other than 90 degrees.

  The uneven distribution means 15 of the present embodiment may be configured not only by the uneven distribution balloon 16 but also by an elastic member (not shown) that can protrude from the distal end side portion of the sheath 10. Various members such as a spring or an elastomer can be used as the elastic member, but it is preferable that the amount of protrusion protruding outward from the sheath 10 can be controlled by the control means. For example, when a spring is used as the elastic member, it is preferable to use a member having a damper means that can control the protrusion amount. In the case of an elastomer, a pressure means that can control the protrusion amount is provided inside. It is preferable. In particular, when a spring is used, it is preferable to provide some cushion member so that pressure can be applied without damaging the inner wall of the urethra.

  The third lumen 13 on the lower side of FIG. 2 is a positioning lumen, and a positioning balloon catheter 20 is provided here. The positioning balloon catheter 20 is guided to the outside through the third lumen 13 and the operation conduit 6, and pressurizing means 17 for introducing fluid pressure into the catheter 20 at the outer end thereof (see FIG. 1). And the control means 18 (refer FIG. 1) which controls the pressurization means 17 is connected. The positioning balloon B is positioned from the distal end of the main body 1 inserted into the bladder, inflated in the bladder, and engaged with the bladder neck 42 (see FIG. 5) to position the main body 1.

  As the pressurizing means 17 of the positioning balloon B, a syringe pump or a roller pump is used as in the case of the unevenly distributed balloon 16, and a gas such as air or a liquid such as physiological saline is supplied to the tip portion for positioning. Balloon B is inflated. The control means 18 is also similar to the uneven distribution balloon 16 and controls the operation of a syringe pump or a roller pump. However, when the syringe pump as the pressurizing means 17 is manually operated, the control means 18 is not necessarily required. There is no need to provide it. The positioning balloon B is preferably made of the same material as the uneven distribution balloon 16.

  As shown in FIG. 2, the sheath 10 is provided with a plurality of light guides 30 and one image guide 31.

  The light guide 30 is for irradiating illumination light necessary for dark part observation, and guides the light irradiated through the light connector 5 of the operation unit 3 to the front of the distal end portion of the sheath 10.

  The image guide 31 includes a large number of light transmissive cores 32 and a clad 33 for fixing them. The image guide 31 guides the subject image formed by the lens 34 provided at the distal end of the sheath 10 to the eyepiece 4.

  The material of the core 32 is not particularly limited as long as it has a refractive index larger than that of the clad 33. However, when the main body 1 is formed flexibly, it is preferably made of plastic having excellent flexibility. Examples of the type of plastic include polymethyl methacrylate, polystyrene, styrene acrylonitrile, polycarbonate, polychlorostyrene, and the like.

  The clad 33 is preferably made of plastic. The type of plastic material is not particularly limited as long as it exhibits a function as a clad, and examples thereof include polymethyl methacrylate, polystyrene, polycarbonate, polyethylene, and polyamide.

  The lens 34 may be of any type as long as it can form a subject image, but a rod lens is preferably used. This is because the attachment to the image guide 31 can be facilitated.

  Next, the operation of this embodiment will be described.

  FIG. 5 is a cross-sectional view showing a state in which the endoscope of the present embodiment is inserted to the bladder neck, and FIG. 6 is a cross-sectional equivalent view taken along line 6-6 of FIG.

  First, the operator applies a syringe pump filled with a biocompatible injection agent to the outer end of the infusion catheter 14 led out from the operation conduit 6 to the port 21 and the outer end of the positioning balloon catheter 20, respectively. Connect a syringe pump for pressure. When the light guide 30 and the image guide 31 are also activated, the setting is completed.

  Next, while viewing the image from the image guide 31 with the eyepiece 4, the main body 1 is inserted through the urethra 40 from the mouth of the external urethra until the tip reaches the bladder 41 as shown in FIG. 5.

  In this state, first, the injection agent is caused to flow out from the tip of the injection needle H, the air in the lumen of the injection needle H is evacuated, and then the injection needle H is returned into the endoscope N. Next, the syringe pump 17 of the positioning balloon catheter 20 is operated to inflate the positioning balloon B in the bladder 41. Since the positioning balloon B is inflated immediately before the distal end of the endoscope N, when the endoscope N is retracted together with the positioning balloon B, the positioning balloon B immediately comes into contact with the bladder neck 42. When the endoscope N is further retracted by a predetermined retraction length L (about 1.5 cm to 2.0 cm) from the contact between the positioning balloon B and the bladder neck 42 (the state shown in FIG. 5), the vicinity thereof Is just near the extraurethral sphincter and is also the injection position of the injection, so that the positioning balloon catheter 20 and the endoscope N are locked so that the endoscope N does not move in the axial direction. The locking may be any means. For example, the positioning balloon catheter 20 is locked at the exit end of the working conduit 6 by a stopper member S (see FIG. 1) such as a clip, and the endoscope N Is fixed in the axial direction.

In this locked state, the uneven distribution means 15 is operated while visually observing with the eyepiece 4. That is, as shown in FIG. 6, the pressurizing syringe pump communicated with the uneven distribution balloon 16 is pressurized to inflate the uneven distribution balloon 16.

  The unevenly distributed balloon 16 gradually expands while controlling the supply of the pressurized fluid by the pressurizing means 17 and the control means 18, and largely protrudes outside the sheath 10, and pressurizes one urethral inner wall surface 40a. With the pressurization of the urethral inner wall surface 40a, the distal end of the sheath 10 is also displaced to the opposite side to the inflating direction of the unevenly distributed balloon 16, and the distal end of the sheath 10 is opposite to the urethral inner wall surface 40a. Distort.

  Since the infusion catheter 14 having the infusion needle H is disposed at a position opposite to the unevenly distributed balloon 16, the distal end portion of the main body 1 can be smoothly displaced, and the displacement amount can be responsive. Therefore, when the injection needle H is punctured, the inner wall of the urethra to be punctured is present immediately before, and the puncture can be performed at a deep puncture angle.

  The surgeon rotates the endoscope N from a horizontal state to a so-called 4 o'clock puncture position, for example, while visually observing the state of change associated with the expansion of the unevenly distributed balloon 16 with the eyepiece 4. When the predetermined position is reached, pressurization of the syringe pump for pressure expansion is stopped. Then, the injection catheter 14 is operated from the outside, punctures the urethral mucosa 43, operates the pressurizing syringe pump, and injects the internal injection agent. A portion of the inner wall of the urethral tube bulges due to the injection of the injection. After injection, the injection needle H is removed and watched for 1-2 minutes. When the wound is closed and the infusate is confirmed not to leak, one injection is now complete.

  Next, the pressurizing syringe pump communicated with the uneven distribution balloon 16 is operated to contract the uneven distribution balloon 16. Then, the endoscope N at the 4 o'clock puncture position is returned to the horizontal state.

  After inverting the endoscope N, the syringe pump for pressurization is actuated again to inflate the ubiquitous balloon 16, displace the distal end of the sheath 10 in the same manner as described above, and distort the urethral inner wall surface 40b with the distal end of the sheath 10. I will.

  The operator turns the endoscope N from the horizontal state to the so-called puncture position at 8 o'clock while keeping the uneven balloon 16 inflated while observing this changed state with the eyepiece 4. When the predetermined position is reached, pressurization of the syringe pump for pressurization is stopped. Then, as described above, the injection catheter 14 is operated from the outside to puncture the urethral mucosa 43, and the injection agent is injected by a pressurizing syringe pump. After the injection, as in the previous case, the injection needle H is withdrawn, and it is confirmed that there is no wound closure and no injection agent leaks.

  After the injection is completed, the uneven distribution balloon 16 and the positioning balloon B are deflated and accommodated in the sheath 10. Then, the endoscope N is removed from the living body.

  The present invention is not limited to the above-described embodiments, and various modifications can be made by those skilled in the art within the technical idea of the present invention. For example, the embodiment described above is used for the treatment of urinary incontinence that narrows the urethra, but the present invention is not limited to this, and the cardia or stomach between the esophagus and the stomach It can also be used to narrow the pylorus between the duodenum.

  The present invention can be used as an endoscope that can easily and safely treat urinary incontinence.

1 is a schematic perspective view showing an endoscope according to a first embodiment of the present invention. It is sectional drawing which follows the 2-2 line of FIG. It is sectional drawing which follows the 3-3 line of FIG. FIG. 4 is a cross-sectional view taken along line 4-4 of FIG. It is sectional drawing which shows the state which inserted the endoscope of this embodiment to the bladder neck part. FIG. 6 is a cross-sectional equivalent view taken along line 6-6 of FIG.

Explanation of symbols

1 ... body,
14 ... Infusion catheter,
15 ... uneven distribution means,
16 ... unevenly distributed balloon,
17 ... Pressure means,
18 ... control means,
19 ... through holes,
20 ... Balloon catheter for positioning,
21 ... Port,
B ... Balloon for positioning,
H ... Injection needle,
N ... Endoscope.

Claims (4)

In an endoscope provided with an injection needle for injecting a biocompatible injection agent into a body tissue in a body inserted into a body cavity,
The main body has three lumens,
The injection needle provided so as to freely protrude and retract in the axial direction from the tip of the main body ;
Uneven distribution means for unevenly distributing the tip of the main body in a direction intersecting the axis of the main body ;
In order to move the main body to the injection position of the infusate in the body cavity, a positioning balloon catheter that is pushed out from the distal direction of the main body and can be fixed in the bladder is provided,
The endoscope characterized in that the uneven distribution means is provided at a position facing a lumen through which the injection needle is inserted with respect to a central axis of the main body . The endoscope according to claim 1, wherein the uneven distribution unit includes an inflatable and defensible balloon provided in the main body. The endoscope according to claim 1, wherein the uneven distribution unit is configured by an elastic member that can protrude from an outer surface of a distal end portion of the main body. The endoscope according to any one of claims 1 to 3, wherein the uneven distribution means can control the amount of protrusion from the outside of the main body by a control means.

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