JP6803691B2 - Flexible puncture needle and rigid mirror - Google Patents

Description

The present invention relates mainly to a flexible puncture needle useful as a medical puncture needle (injection needle), and a rigid mirror using the flexible puncture needle.

Rigid mirrors such as cystoscopes and laparoscopes usually have a tubular insertion part called a shaft, and a treatment tool such as a puncture needle is inserted and attached to the inside (lumen) of this shaft. .. When treating the affected area using a rigid scope, the shaft is first inserted into a capillary tube such as the urethra or a vessel. Then, while observing the inside of the thin tube with an observation unit such as an objective lens or a camera provided at the tip of the shaft, the shaft is inserted until the tip reaches the vicinity of the affected part existing on the side wall constituting the thin tube, and then the rising table is used. A so-called operating mechanism is raised to bend the vicinity of the tip of the puncture needle so that the needle tip faces the side wall. Then, the puncture needle is pushed out from the tip of the shaft with the vicinity of the tip of the puncture needle bent, and the needle tip is punctured into the affected portion.

However, since the puncture needle is usually a metal member having a certain degree of rigidity such as stainless steel, it is difficult to greatly bend the vicinity of the tip even when the riser is raised. For this reason, the distance between the affected part to be punctured and the observation part such as an objective lens provided at the tip of the shaft has to be widened, which may make accurate puncture difficult.

As a related technique for solving the above-mentioned problems, for example, a puncture needle for an endoscope formed of a flexible resin such as PEEK resin has been proposed (Patent Document 1). Further, an injection needle for a catheter having a flexible portion in which a spiral slit is formed has been proposed (Patent Document 2).

Japanese Unexamined Patent Publication No. 2004-181036 JP-A-2015-134117

By the way, when puncturing a plurality of times by changing the puncturing position, first, the rising table is tilted to retract the needle tip of the puncture needle into the shaft, and then the insertion depth and the rotation angle of the shaft are changed. Next, while raising the riser and bending the vicinity of the tip of the puncture needle, the puncture needle is pushed out again from the tip of the shaft to puncture the affected portion.

However, when the vicinity of the tip of the puncture needle or the like proposed in Patent Documents 1 and 2 is repeatedly bent, deformation such as distortion and swell gradually occurs in the puncture needle. For this reason, as the number of punctures increases, it may become gradually difficult to puncture the target location accurately. Further, since a flexible resin such as PEEK resin constituting the puncture needle proposed in Patent Document 1 is a relatively expensive material, the puncture needle composed of such a resin is not necessarily highly versatile. It couldn't be said to be a thing.

The present invention has been made in view of the problems of the prior art, and the problem thereof is that repeated bending is possible in the vicinity of the needle tip and liquid leakage from a place other than the needle tip. A highly versatile flexible puncture needle that can accurately and easily puncture a limited area such as the target affected area without equalization, and a rigid mirror using the needle. To provide.

As a result of diligent studies to solve the above problems, the present inventors have found that the above problems can be solved by adopting the following configuration, and have completed the present invention.

That is, according to the present invention, the flexible puncture needle shown below is provided.
[1] A flexible puncture needle used by being attached to a rigid mirror body having a riser, which has a tip and a base end on which a needle tip is formed, and a slit penetrating into the tube of the needle tip. A tubular canula made of metal formed in the vicinity and a tubular coating layer made of elastic resin that covers the slit are provided, and the tubular coating layer is arranged in close contact with the outer peripheral surface of the canula. , A flexible puncture needle fixed to the outer peripheral surface of the canula at both outer ends of the region where the slit is formed.
[2] The flexible puncture needle according to the above [1], wherein the tubular coating layer is formed by heat-shrinking a heat-shrinkable tube.
[3] The flexible puncture needle according to the above [1] or [2], wherein the slit is a spiral slit formed spirally along the longitudinal direction of the canula.
[4] The flexible puncture needle according to the above [3], wherein the distance between the spiral slits becomes narrower as the distance from the tip thereof increases.
[5] The flexible puncture needle according to the above [3] or [4], wherein the turning direction of the spiral slit is different between the tip end side and the base end side.

Further, according to the present invention, the rigid mirror shown below is provided.
[6] The flexible puncture according to any one of [1] to [5] above, wherein a rigid mirror body having a shaft having a riser arranged in the vicinity of the tip thereof and the rigid mirror body inserted and mounted in the shaft A rigid mirror with a needle.
[7] The rigid scope according to the above [6], which is a cystoscope, a laparoscope, an endoscope, or a bronchoscope.

According to the present invention, repeated bending is possible in the vicinity of the needle tip, liquid does not leak from a place other than the needle tip, and the needle tip is accurately and easily punctured in a limited place such as a target affected area. It is possible to provide a highly versatile flexible puncture needle that can be processed. Further, according to the present invention, it is possible to provide a rigid mirror using the above-mentioned flexible puncture needle.

It is a side view which shows typically one Embodiment of the flexible puncture needle of this invention. It is an enlarged view of the part A of FIG. It is a partially enlarged view which shows an example of a slit schematically. It is a partially enlarged view which shows another example of a slit schematically. It is a schematic diagram which shows one aspect of the spiral slit formed in the canula. It is a partial cross-sectional view schematically showing an example of a state in which the flexible puncture needle of the present invention is bent. It is a side view which shows an example of a rigid mirror main body. It is a partial cross-sectional view schematically showing an example of the movement of a flexible puncture needle when using the rigid mirror of this invention.

<Flexible puncture needle>
Hereinafter, embodiments of the present invention will be described, but the present invention is not limited to the following embodiments. FIG. 1 is a side view schematically showing an embodiment of the flexible puncture needle of the present invention, and FIG. 2 is an enlarged view of part A of FIG. As shown in FIGS. 1 and 2, the flexible puncture needle 10 of the present embodiment includes a tubular canula 15 having a hollow portion inside which a fluid such as a chemical solution can flow. The canula 15 is made of, for example, a metal such as stainless steel (SUS), which is highly versatile as a constituent material of a medical puncture needle.

A needle tip 25 is formed at the tip 22 of the canula 15, and a needle base 27 that can be connected to another treatment tool such as a syringe is arranged at the base end 24. Further, in the vicinity of the needle tip 25 of the canula 15, a spiral slit 50 is formed so as to penetrate from the outer periphery of the canula 15 into the pipe, and a flexible portion 55 having increased flexibility of the canula 15 is formed. ing. Then, the tubular coating layer 60 made of elastic resin is arranged so as to cover the spiral slit 50 penetrating the inside of the tube of the canula 15. Since the tubular coating layer 60 is arranged, a fluid such as a chemical solution flowing in the tube of the canula 15 is prevented from flowing out through the spiral slit 50.

The type of elastic resin constituting the tubular coating layer is not particularly limited, but it is preferably a resin that is acceptable as a medical material. Among them, the tubular coating layer is preferably a layer formed by heat-shrinking a heat-shrinkable tube from the viewpoint of manufacturing. As the heat-shrinkable tube, for example, a generally available commercially available heat-shrinkable tube made of a thermoplastic elastomer such as a polyamide resin, a fluororesin, or a silicone resin; or a resin such as a polyolefin can be used. The tubular coating layer may be transparent or colored.

FIG. 6 is a partial cross-sectional view schematically showing an example of a state in which the flexible puncture needle of the present invention is bent. For convenience of explanation, only the tubular covering layer 60 is shown in cross section in FIG. As shown in FIG. 6A, the tubular covering layer 60 is arranged in close contact with the outer peripheral surface of the canula 15. Further, the tubular covering layer 60 is fixed to the outer peripheral surface of the canula 15 at both outer ends of the region where the slit is formed, and the fixing portions 70a and 70b are formed. Both ends of the inner peripheral surface of the tubular coating layer 60 are fixed to the outer peripheral surface of the canula 15 over the entire circumference of the canula 15 by, for example, fixing means such as a UV curable resin or an adhesive to the fixing portions 70a and 70b. It is formed. That is, the tubular covering layer 60 is arranged in close contact with the outer peripheral surface of the canula 15, but the portions other than the fixing portions 70a and 70b are not fixed to the outer peripheral surface of the canula 15. When a stress is applied to the flexible puncture needle of the present invention having such a configuration, as shown in FIG. 6B, the slits 30 can be greatly bent in the stress loading direction while increasing the interval. .. Since the portions of the tubular coating layer 60 other than the fixing portions 70a and 70b are not fixed to the outer peripheral surface of the canula 15, the expansion of the slit 30 spacing is not easily hindered and can be smoothly bent.

Further, since the tubular coating layer 60 is made of elastic resin and is fixed to the outer peripheral surface of the canula 15 at both outer ends of the region where the slit is formed, it is located on the outer side of the tubular coating layer 60 at the time of bending. The part to be stretched is in an extended state. Therefore, when the stress load is released, the restoring force of the tubular covering layer 60 enables smooth restoration from the bent state to the original linear state. Therefore, since the flexible puncture needle of the present invention not only bends but also restores to the original linear state smoothly, deformation such as distortion and swell is unlikely to occur even when repeatedly bent.

Further, as shown in FIG. 6B, at the time of bending, the portion of the tubular covering layer 60 located inside the bending is in close contact with the outer peripheral surface of the canula 15 in a compressed state, and therefore is adjacent to the tubular covering layer 60 partitioned by the slit 30. Riding between the units 52a and 52b is suppressed. As a result, it is possible to smoothly restore the bent state to the original straight state, and the force pushing the needle tip (tip) toward the target affected area does not escape (does not decrease), making it easier and more accurate. Puncture is possible.

The mode of the slit is not particularly limited, but it is preferably a mode formed in the direction of turning around the outer circumference of the canula. As a mode of the slit, for example, in addition to the spiral slit 50 formed spirally along the longitudinal direction of the canula as shown in FIG. 2, a plurality of blocks of the canula in the longitudinal direction as shown in FIG. 3 ( An annular slit 51 formed so as to be divided into the unit) 45 can be mentioned. Of these, a spiral slit is preferable because it is easy to shape.

As will be described later, the spiral slit can be formed along the longitudinal direction of the canula by a processing method such as laser processing. When the spiral slit is formed by a processing method such as laser machining, it is preferable to form the spiral slit 65 so that the turning direction is different between the tip end side and the base end side of the canula, as shown in FIG. In the case of the laser processing method, a rotational torque is usually applied to the canula, and the canula is rotated in the circumferential direction to form a spiral slit. However, the rotational torque is easily transmitted in the rotational direction in which the spiral slit is narrowed down, but is difficult to be transmitted in the rotational direction in which the spiral slit is loosened. Therefore, by changing (reversing) the rotation direction of the canula during laser processing, it is possible to suppress a decrease in rotational torque transmission to the canula and rotate the canula accurately. According to the laser processing method, it is possible to form an excellent spiral slit due to dimensional accuracy and the like.

The distance between the spiral slits 50 is preferably narrowed as the distance from the tip 22 of the canula 15 increases (FIG. 2). With this configuration, the rigidity of the canula 15 can be gradually reduced from the tip 22 toward the base end. Therefore, it can be smoothly bent while maintaining the rigidity of the portion close to the needle tip 25 for puncturing the target affected area, and more accurate puncture is possible. The distance between the spiral slits may be continuously narrowed as the distance from the tip is increased, or may be gradually narrowed as shown in FIG.

FIG. 5 is a schematic view showing one aspect of the spiral slit formed in the canula. A spiral slit is formed in the canula 15 shown in FIG. Further, the distance between the spiral slits is formed so as to be gradually narrowed as the distance from the needle tip 25 increases. The length from the needle tip to the base end of the canula constituting the flexible puncture needle of the present invention (total length L), the length T of the needle tip, and the length of the slit-forming portion (length F of the flexible portion). Is not particularly limited, and may be appropriately designed according to the purpose. To give a specific example, the total length L is usually about 280 to 480 mm, preferably about 330 to 430 mm. The length T of the needle tip is usually about 4 to 20 mm, preferably about 7 to 16 mm. The total length F of the flexible portion is usually about 20 to 80 mm, preferably about 30 to 60 mm. The interval of the spiral slits (pitch P _1, P ₂₎ can be designed as appropriate depending on the extent to which attempts to bend. Specific examples, the pitch P _1, P ₂ of the spiral slit is generally about 0.3 to 3.0 mm, preferably about 0.5 to 1.5 mm.

The flexible puncture needle of the present invention can be manufactured, for example, according to the procedure shown below. First, a stainless steel tube is prepared, and a slit such as a spiral slit is formed in the vicinity of one tip in the longitudinal direction of the tube. The slit can be formed by a processing method such as laser processing. Next, one tip is processed into a needle shape to form a needle tip to obtain a canula. A needle base for connecting another treatment tool such as a syringe is arranged at the other end (base end) of the obtained canula. The needle base can be arranged at the base end of the canula using, for example, various adhesives such as UV curable resin. Then, various adhesives such as UV curable resin are applied to both outer ends of the formed slit. In order to maintain the shape of the canula stably and facilitate the work, it is preferable to insert the core metal into the pipe (hollow portion) of the canula as needed. After applying the adhesive, the canula is inserted into a heat-shrinkable tube of an appropriate length, and heat is applied to heat-shrink the heat-shrinkable tube from the needle tip (tip) side to cover the slit and the canula. A tubular coating layer in close contact with the outer peripheral surface is formed. After that, the adhesive applied to both outer ends of the slit is cured by irradiating with UV light to form fixing portions at both ends in the longitudinal direction of the tubular coating layer, and the used core metal is removed if necessary. , The flexible puncture needle of the present invention can be obtained.

<Hard mirror>
Next, the rigid mirror of the present invention using the above-mentioned flexible puncture needle will be described. The rigid mirror of the present invention includes a rigid mirror body having a shaft and the above-mentioned flexible puncture needle inserted and mounted in the shaft.

FIG. 7 is a side view showing an example of the rigid mirror main body. As shown in FIG. 7, the rigid mirror body 100 includes a long rod-shaped shaft 105. A lumen, which is a space extending in the longitudinal direction, is formed in the shaft 105. The lumen in the shaft 105 is an internal space into which the above-mentioned flexible puncture needle is inserted and mounted. Further, a main port 110 having an eyepiece and the like and an operation unit 120 having a subport 115 as an insertion port for various treatment tools are connected to the base of the shaft 105. Further, the operation unit 120 is provided with a control unit such as a dial 130 for controlling the movement of the raising table arranged at the tip end portion 125 of the shaft 105. The tip (tip) of the flexible puncture needle is inserted from the sub port 115 and mounted in the shaft 105. The inside of the shaft 105 is configured so that a member such as a fiberscope and other treatment tools can be inserted and mounted.

FIG. 8 is a partial cross-sectional view schematically showing an example of the movement of the flexible puncture needle when using the rigid mirror of the present invention. For convenience of explanation, only the shaft 105 is shown in cross section in FIG. As shown in FIG. 8A, the tip portion 125 of the shaft 105 is provided with a raising base 150 that bends the vicinity of the tip of the flexible puncture needle 10. When the raising table 150 is not raised (tilted), the flexible puncture needle 10 is inserted and mounted in the shaft 105 of the rigid mirror body in a straight state or a slightly bent state at the flexible portion 55. ing. Then, when the raising table 150 is raised, the end portion of the raising table 150 comes into contact with the vicinity of the tip of the flexible puncture needle 10, and the region X of the flexible portion 55 closer to the needle tip 25 is desired. It can be bent to some extent (Fig. 8 (b)). The position and movement of the needle tip 25 can be observed at the eyepiece of the main port provided at the base of the shaft 105 through the observation means 160 such as an objective lens arranged at the tip 125 of the shaft 105. ..

When the flexible puncture needle 10 is pushed forward with the raising table 150 raised, the region Y closer to the needle base of the flexible portion 55 is gradually bent (FIG. 8 (c)). At the same time, the stress load from the riser 150 is released from the region X of the flexible portion 55 that has passed the contact point with the riser 150, so that the original linear state is smoothly restored (FIG. 8). (C)). As a result, it is possible to puncture more easily and accurately without releasing the force for pushing the needle tip 25 toward the target affected area.

Further, since the flexible puncture needle 10 used in the rigid mirror of the present invention has a flexible portion 55 in which a slit is formed, it is possible as compared with the case where a conventional puncture needle in which a slit is not formed is used. It can be bent more at the flexed portion 55 (FIGS. 8 (b) and 8 (c)). Therefore, by using the rigid mirror of the present invention, it is possible to narrow the distance between the target affected portion and the observation means 160 such as an objective lens disposed on the tip portion 125 of the shaft 105, and more accurately. Can be punctured. Therefore, the rigid scope of the present invention is useful as, for example, a cystoscope, a laparoscope, an endoscope, and a bronchoscope.

Hereinafter, the present invention will be specifically described based on examples, but the present invention is not limited to the following examples.

<Manufacturing of puncture needles>
(Example 1)
A stainless steel tube was prepared, and a spiral slit was formed by laser processing near one tip in the longitudinal direction of the tube. Next, one tip was processed into a needle shape to form a needle tip 25, and a canula 15 was obtained (FIG. 5). The dimensions of each part of the obtained canula 15 are shown below.
Overall length L: 402 mm
Needle tip length T: 12 mm
Overall length of flexible part F: 38mm
Length of flexible part on the needle tip side F ₁ : 12 mm
Length of flexible part on the needle base side F ₂ : 26 mm
Pitch of spiral slit on the needle tip side P ₁ : 0.8 mm
Pitch of spiral slit on needle base side P ₂ : 0.6mm

A needle base was arranged at the base end of the obtained canula using a UV curable resin (adhesive), and then UV curable resin (adhesive) was applied to both outer ends of the spiral slit. Insert a canula into a heat-shrinkable tube (product name "Palladium" (PEBAX 72D), model number "P2-060-010-CLR", Cobalt polymers, Inc., heat-shrinkable temperature 150-170 ° C.) to heat. The heat-shrinkable tube was heat-shrinked from the needle tip side to cover the spiral slit, and a tubular coating layer in close contact with the outer peripheral surface of the canula was formed. The adhesive applied to both outer ends of the spiral slit was cured by irradiating with UV light to form a fixed portion, and a flexible puncture needle was obtained.

As the heat-shrinkable tube, for example, a heat-shrinkable tube made of FEP (fluorinated ethylene tetrafluoride / propylene hexafluoride copolymer) (product name "ultrafine FEP fluororesin heat-shrinkable tube", model number "NFL013", manufactured by Junko Co., Ltd. , A heat shrinkage temperature of 150 to 170 ° C.) or the like can be used to obtain a flexible puncture needle having the same performance.

(Example 2)
A puncture needle was obtained in the same manner as in Example 1 described above, except that the dimensions of each part of the canula were shown below.
Overall length L: 402 mm
Needle tip length T: 12 mm
Overall length of flexible part F: 33mm
Length of flexible part on the needle tip side F ₁ : 12 mm
Length of flexible part on the needle base side F ₂ : 21 mm
Pitch of spiral slit on the needle tip side P ₁ : 0.8 mm
Pitch of spiral slit on needle base side P ₂ : 0.6mm

(Comparative Example 1)
Except that UV curable resin (adhesive) was applied not only to the outer ends of the spiral slit but also to the area where the spiral slit was formed to form a tubular coating layer that was entirely fixed to the outer peripheral surface of the canula. , A puncture needle was obtained in the same manner as in Example 1 described above.

(Comparative Example 2)
A puncture needle was obtained in the same manner as in Example 1 described above, except that a spiral slit was not formed and a tubular covering layer was not formed.

(Comparative Example 3)
A puncture needle was obtained in the same manner as in Example 1 described above, except that the spiral slit was not formed.

<Evaluation>
Each puncture needle manufactured in Examples 1 and 2 was inserted from a subport of a commercially available cystoscope (model number "A2203A (J) 70 ° 4 mm", manufactured by Olympus Corporation), and the needle tip was advanced to the tip of the shaft. After raising the raising table provided at the tip of the shaft to the maximum extent, the needle tip was moved in and out 10 times with the raising table raised, and the chicken breast was punctured. As a result, it was found that regardless of which puncture needle was used, it was possible to puncture the target location straight to a depth of 12 mm with less resistance. It was confirmed that even if water was injected at the time of puncture, the liquid did not leak from the flexible part. After that, the straightness of the puncture needle extracted from the cystoscope was visually confirmed. As a result, there was a slight swell in all of the puncture needles, but there was almost no swell or distortion in the flexible portion where the slit was formed. It is presumed that the slight swell was generated in the entire puncture needle because the subport (the part where the puncture needle was inserted) of the cystoscope used was bent.

On the other hand, when each of the puncture needles manufactured in Comparative Examples 1 and 2 was attached to the cystoscope in the same manner as described above to raise the riser, the resistance was large and it was difficult to bend the puncture needles significantly. .. Also, if you try to bend it forcibly, the part where the stress is concentrated will buckle (kink), and even if you tilt the riser and release the stress load, it may be difficult to return to the original straight shape. all right. Further, the puncture needle manufactured in Comparative Example 3 was attached to the cystoscope in the same manner as described above to raise the riser, but the puncture needle could not be bent significantly, and the puncture needle was punctured at the target location. Was difficult.

The flexible puncture needle of the present invention is useful as a puncture needle for a rigid mirror such as a cystoscope, a laparoscope, an endoscope, and a bronchoscope.

10: Flexible puncture needle 15: Canula 22: Tip 24: Base end 25: Needle tip 27: Needle base 30: Slit 45: Block (unit)
50, 65: Spiral slit 51: Circular slit 52a, 52b: Unit 60: Tubular coating layer 70a, 70b: Fixed part 100: Rigid mirror body 105: Shaft 110: Main port 115: Subport 120: Operation part 125: Tip Unit 130: Dial (control unit)
150: Rise stand 160: Observation means

Claims (6)

A flexible puncture needle used by attaching to a rigid mirror body having a riser.
A metal tubular canula having a tip and a base end on which a needle tip is formed and a slit penetrating into the tube formed in the vicinity of the needle tip.
A tubular coating layer made of an elastic resin that covers the slits is provided.
Said tubular covering layer together are arranged in close contact with the outer peripheral surface of the cannula, the slit is fixed to the outer peripheral surface of the cannula at the outside ends of the formed region, the fixing portion and the proximal side of the distal Each fixed part is formed,
The slit is a spiral slit formed spirally along the longitudinal direction of the canula.
The distance between the spiral slits becomes narrower continuously or stepwise from the fixing portion on the tip side to the fixing portion on the base end side as the distance from the tip ends .
Flexible puncture needle. The flexible puncture needle according to claim 1, wherein the tubular coating layer is formed by heat-shrinking a heat-shrinkable tube. The flexible puncture needle according to claim 1 or 2, wherein the turning direction of the spiral slit is different between the tip end side and the base end side. Claims 1 to 1, wherein the distance between the spiral slits is continuously or stepwise narrowed from the vicinity of the center of the fixing portion on the tip end side and the fixing portion on the proximal end side toward the anchoring portion on the proximal end side. 3. The flexible puncture needle according to any one of 3. A rigid mirror body having a shaft with a riser arranged near its tip,
A rigid mirror comprising the flexible puncture needle according to any one of claims 1 to 4 , which is inserted and mounted in the shaft. The rigid scope according to claim 5 , which is a cystoscope, a laparoscope, an endoscope, or a bronchoscope.

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