JP5502431B2 - Epidural needle - Google Patents

Description

  The present invention relates to a medical puncture needle used for injecting an anesthetic or an analgesic into an epidural space for anesthesia or pain treatment. Specifically, the anesthetic is repeatedly, divided, or sustained. The present invention relates to an epidural needle for guiding a catheter for continuous administration (hereinafter also referred to as continuous (target)) to the epidural space.

Epidural anesthesia and epidural analgesia (also referred to as epidural anesthesia) include anesthetics and analgesics (hereinafter anesthesia together) in the epidural space outside the dura mater in the spinal canal. in procedure for injecting drugs), in the case of injection only once, and the puncture needle tube (epidural needle) until cured film extracellular space, but to inject liquid medicine through the epidural needle, anesthesia Ya In the case of continuous epidural anesthesia in which analgesia is carried out continuously over a long period of time, the tip of an elongated catheter (epidural catheter) having a diameter of about 1 mm is placed in the epidural space through the needle tube, and the needle tube is removed. In addition, by holding the catheter proximal end outside the body, a method of injecting a chemical solution such as a local anesthetic into the epidural space continuously through the catheter is employed, and anesthesia with relatively few side effects As a means, it is widely used in various surgeries, postoperative analgesia, and various pain countermeasures. .

Conventionally, the epidural needle used in this procedure is a double needle composed of an outer needle made of a stainless steel tube and a solid inner needle in which stainless steel or a needle tip formed of fluorine resin or the like is connected to the tip of stainless steel. The tip of the needle tube is composed of a needle, and the tip of the needle tube is curved to prevent or reduce complications due to accidental dural puncture with a sharp edge, and to allow the catheter to easily protrude into the epidural space (Huber point).
However, since this conventional epidural needle needs to be inserted into the lumen of the outer needle, in order to insert a 0.8 mm catheter, which is the outer diameter of a general epidural catheter, It is necessary to use a needle tube having a diameter of about 1.26 mm, and this means that a needle tube that is about 2.5 times as large as the catheter is actually used. The thickness of such a needle tube increases the frequency and extent of headaches caused by accidental dural puncture during the procedure, as well as the frequency and extent of damage to patient tissues such as bleeding and nerve damage. It is a factor to increase. Further, in the above structure, since the catheter is inserted via a needle tube having a metal blade surface, the catheter hits the blade surface of the needle tube, there is a risk of damaging the catheter, and in the worst case, cutting, Such operations are contraindicated in cases where the catheter is easily damaged when it is pulled back or pushed forcibly even though there is resistance. In addition, there is a problem that accidents such as damage or cutting due to careless pulling occur due to the trouble of this re-puncture.

Therefore, the present inventors have made an outer needle having an outer diameter substantially the same as the outer diameter of the epidural anesthesia catheter used for the treatment as an epidural needle that solves the above-described problems, and the outer needle. A puncture needle composed of an inner needle that is detachably slidable and an outer cylindrical tube that is made of a flexible resin that is brazed in a curved shape. The puncture needle is placed in the lumen of the outer cylindrical tube. There has been proposed an epidural needle that is slidably and detachably inserted and formed so that the blade surface of the puncture needle protrudes from the distal end portion of the outer tube at the deepest part of the insertion. (Patent Document 1)
According to this epidural needle, the outer diameter of the needle tube can be made smaller than when the same epidural catheter is inserted, and the insertion of the catheter is an outer tube of a flexible resin. By inserting the catheter through the catheter, it is possible to eliminate the catheter damage and cutting problems caused by the catheter hitting the metal blade surface as in the past. The effect that operation becomes possible can be expected.

JP 2005-2111268 A

  However, in the epidural needle, the puncture needle is slidably and detachably inserted into the lumen of the outer tube, and generally the puncture is performed by grasping only the puncture needle base. There is a concern that the outer tube and the puncture needle may be separated due to an operation of moving the needle back and forth during adjustment of the puncture position, etc., and when the puncture needle is inserted into the outer tube, Therefore, depending on the angle direction of the puncture needle, there is a risk that the outer tube will be damaged by the cutting edge of the puncture needle and, in the worst case, it will break through.

  Accordingly, the present invention is a device that is minimally invasive and safe for the patient with low complications related to the puncture of the epidural needle, and that is not intended during use, and that is not intended during use. An object of the present invention is to provide an epidural needle excellent in ease of use that prevents separation and reduces the risk of damage to the outer tube due to the puncture needle.

The epidural needle of the present invention is a puncture needle composed of an inner / outer double needle formed at the outer needle tip at a Huber point and a slidably covered outer needle of the puncture needle. The outer tube is made of a flexible resin, and the outer needle base of the puncture needle and the outer tube tube base are only at a specific position where the bending of the outer needle tube and the curve of the outer tube are the same. A wing provided with a fitting locking part that fits , is detachable and does not easily disengage, and the fitting locking part has locking means with an outer needle base provided on the outer tube tube base. And a space for receiving the outer cylindrical tube base including the wing provided on the outer needle base and a fitting receiving portion, and the wing is formed to project outward from the outer cylindrical tube in a symmetrical direction. And a protrusion for holding the puncture needle, and movable in a direction close to the axis of the wing for releasing the locking by the protrusion It is configured to include that space.

In concrete terms, for example, locking means provided on the blade is inclined in the direction of insertion into the outer needle base, formed as projections angled portion removing direction while engaging with the outer needle hub The receiving portion is formed and configured as a locking portion that holds the corner portion of the protrusion.
Further, as a means for releasing the locking, for example, by pressing the wing portion from both sides toward the central axis direction, the projection is detached from the locking portion, and the outer tube base and the outer needle base can be detached. Configure to be

Also, before Kitsubasa it is preferably formed asymmetrically outer cylinder tube group as a central axis.

According to the epidural needle of this configuration, the puncture needle is removed after puncturing into the epidural space, and the catheter is inserted through the outer tube, so the outer diameter of the puncture needle outer needle is It is sufficient to use a needle tube that can be inserted through the tube, which is almost equivalent to the outer diameter of the catheter to be used. This can reduce the frequency and extent of complications such as headaches associated with accidental dural puncture, which may be derived from a thick needle tube, bleeding, and patient tissue damage such as nerve damage. it can.
Further, as described above, the insertion of the catheter can be performed through a flexible resin, so that the catheter damage and cutting problems caused by the catheter hitting the metal blade surface can be solved. In this case, the withdrawal operation at the time of insertion of the catheter, which was contraindicated, becomes possible, and it is possible to provide a safe and easy-to-use instrument that does not require re-puncture when the withdrawal is necessary.

Also, it is detachable and easy to fit and lock to the outer needle base and outer tube tube base of the puncture needle only at a specific position where the bending direction of the outer needle tube and the curve of the outer tube tube are the same. By providing a fitting locking portion that does not disengage, the insertion of the puncture needle into the outer tube is easily limited to only a specific direction in which the curvature matches, so that the bent portion of the Huber point of the puncture needle outer needle is removed. Since it is inserted in contact with the curvature of the tube, it is possible to reduce the risk of damage to the outer tube due to the cutting edge of the puncture needle when the puncture needle is inserted into the outer tube. By being brazed into a curved shape, the catheter tip is not directly hitting the dura mater when the catheter is delivered in the epidural space, reducing the risk of dural damage caused by the catheter, and in the desired direction Can be inserted smoothly.
In addition, since the outer needle base and the outer tube are locked and do not easily disengage, the puncture needle can be used even when only the puncture needle base is gripped during operations such as pulling back the needle during puncture. It can be set as the instrument which an outer cylinder pipe does not leave | separate.
Further, by pressing the wing, the outer tube base and the outer needle base can be detached, so that the structure cannot be easily detached when worn. The locking by the stopper can be easily released with one touch.

Also, if the wing of the outer tube is formed asymmetrically with the outer tube tube base as the central axis, the insertion direction of the puncture needle into the inner tube can be identified at a glance, and if the direction is wrong, it cannot be attached, A mistake in the mounting direction can be eliminated .

  As described above, in addition to being a low-invasive and safe instrument for a patient with low complications related to puncture of an epidural needle, the present invention has an issue, and an outer tube that is not intended during use. It is possible to provide an epidural needle excellent in usability that prevents the puncture needle from being detached and reduces the risk of damage to the outer tube due to the puncture needle.

BRIEF DESCRIPTION OF THE DRAWINGS It is a whole block diagram of the epidural needle | hook showing embodiment of this invention, A is a state before mounting | wearing with a puncture needle and an outer cylinder tube, and B is a state after mounting | wearing. It is a block diagram which shows the front end side (needle tube, tube front end side) part of the outer tube | pipe and puncture needle outer needle of the said embodiment, A is in the middle of insertion of the puncture needle to an outer cylinder tube, and B is the state after insertion. The block diagram of 4 surfaces (a front view, a side view, a top view, a bottom view) which shows the puncture needle of the said embodiment. It is a block diagram which shows the outer cylinder pipe of the said embodiment, A is a front view and a side view, B is a front enlarged view of an outer cylinder pipe base part. The expanded block diagram of the base part which shows the state which inserted the puncture needle into the outer cylinder pipe | tube of the said embodiment.

Hereinafter, embodiments of the present invention will be described in detail with reference to the drawings.
The epidural needle according to the present embodiment is composed of a puncture needle 10 and an outer tube 40, and the puncture needle 10 is slidably inserted into the outer tube 40 and is detachably inserted.
Except for the structure of the outer needle base 2, the puncture needle 10 is slidable in the outer needle 1 and the lumen of the outer needle 1 in the same manner as a conventional epidural needle as described in Patent Document 1, for example. An inner needle (not shown) that is inserted into the inner needle, a cutting edge is formed at the distal end of each of the inner and outer needles, and an outer needle base 2 and an inner needle base 3 are provided at the proximal end, respectively. It is configured as a double needle fitted with a female taper provided on the base 2 and a male taper provided on the inner needle base 3. When fitting, the cutting edge direction indicators 24 and 31 provided on the outer needle base 2 and the inner needle base 3 are matched so that the cutting edges of the inner and outer needles coincide with each other.
On the other hand, the outer cylinder tube 40 has an outer cylinder tube base that is fitted to the outer needle base 2 of the puncture needle 10 at the proximal end portion of the outer tube 4 that is chamfered at the distal end portion and brazed at the distal end side. 5 is connected.
Then, the puncture needle 10 is inserted into the lumen of the outer tube 4 of the outer tube 40, and the fitting provided in the outer tube tube base 5 described later, the fitting provided in the locking means and the outer needle base 2, and the locking receiver The outer tubular tube base 5 and the outer needle base 2 are fitted and locked by the portion to form the dura outer needle of this example. At this time, the tip of the puncture needle 10 is adjusted so that at least the cutting edge protrudes from the tip of the outer tube 4 in the deepest insertion portion that is fitted and locked.

Next, it will be described in detail for each part of the configuration.
The puncture needle 10 is composed of an outer needle and an inner needle as described above, and the outer needle 1 is made of a stainless steel tube, and the outer diameter size is selected depending on the catheter to be used, but is generally used for continuous epidural anesthesia. 20G (outer diameter 0.88mm) for 0.8mm catheters (previously 18G (outer diameter 1.26mm) was used), 19G for 1.0mm catheters (outer diameter 1.06mm) (In the past, 17G (outer diameter of 1.48 mm) was used) was selected, and the length was about 80 mm to 120 mm, which is the length of a typical epidural needle. Further, the tip portion 11 was configured as a Huber point with a cutting edge attached to a curved portion similar to the conventional one, and a scale (not shown) serving as an index of puncture depth was provided on the needle tube at intervals of 10 mm. The tip 11 of the outer needle 1 is used as a Huber point in order to minimize damage to the dura even if the needle tip hits the dura mater when puncturing the epidural space. This is a consideration for not damaging the lumen of the curved outer tube 21 to be described later.
The outer needle base 2 provided at the proximal end portion of the outer needle 1 is a resin molded product, and is formed like an outer needle basic body 21 located on the central axis of the outer needle base 2 and a side wall surrounding the main body 21. A fitting receiving portion 22 provided with a blade receiving hole 221 formed as a notch space on the opposite surface of the side wall, and a wide area so as to be held during puncture and facilitate the puncture The outer needle blade 23 and the index 24 indicating the direction of the cutting edge 11 of the outer needle 1 were used.
The outer needle basic body 21 is formed with a female taper that connects the outer needle 1 by bonding on the front end side and a rear taper side that fits with the male taper of the inner needle base 3. The fitting receiving portion 22 is a space for accommodating a gap between the main body 21 and a female taper portion (outer tube tube basic body 51) of the outer tube tube base 5 described later, like a side wall surrounding the outer needle basic body 21. ), And a pair of opposing surfaces of the side wall are formed with notches, and together with the notches provided on the outer needle blades 23 communicating with the notches, outer cylinders to be described later A blade receiving hole 221 is formed as a space for accommodating the tube base 5. The outer needle wing 23 is provided on the distal end side of the outer needle base 2 as a gripping portion for facilitating puncturing similarly to a general epidural needle, and in this example, the wing receiver of the fitting receiving portion 22 is provided. The hole 221 communicates with each other, and is provided with a notch portion of a long hole that accommodates the outer tube tube base 5 to be described later, and the corner portion of the opposed rising surface on the long side of the long hole is fitted to the outer tube tube base 5. It was formed as a locking portion 222 that locks the joint. The direction index 24 of the blade tip of the outer needle 1 is provided on the edge of the outer needle blade 23 at the middle position in the longitudinal direction, and is an index for bonding the outer needle 1 to the outer needle base 2 or the blade edge direction for puncture. Used as an indicator of
The inner needle is made of a stainless steel rod, and is provided with a blade surface that fits and matches the outer needle 1 at the tip, and is formed to have an outer diameter and a length that match the lumen of the outer needle 1. The inner needle base 3 is configured by connecting the inner needles by adhesion, and providing a groove 31 serving as an index in the cutting edge direction and a male taper that fits with the female taper of the outer needle basic body 21. The inner needle may be a conventional one in which a resin such as a fluororesin is connected to the tip of a stainless steel pipe by caulking or the like in consideration of ease of manufacture. Further, the tip of the inner needle is not particularly processed to have a curved shape, but since it has a small diameter, when it is inserted into the lumen of the outer needle, it naturally follows the curved shape of the outer needle.
The puncture needle 1 is formed by fitting the inner and outer needles formed in this manner. When fitting, the index of the cutting edge of the inner and outer needle bases described above is matched so that the blade surfaces of the inner and outer needles match ( It is set so that the inner needle does not protrude from the outer needle at least at the most distal part.

The outer tube 40 is composed of an outer tube 4 and an outer tube base 5 that is bonded to the base end of the outer tube 4 or connected via a connector (not shown).
The outer tube 4 is made of a transparent or translucent resin (fluorine resin in the present embodiment) that is flexible and can be used to confirm the scale of the outer needle. When the puncture needle 10 is inserted with a possible inner diameter, the tip blade surface portion (Huber Pont) 11 of the puncture needle 10 is adjusted to a length that projects, and the tip portion 41 is chamfered to facilitate insertion into the tissue. is, the distal end side (curved portion) 42 is the axial direction of the outer cylinder tube group 5, (as there is no straight portion) continuous manner as is shaping the curved shape formed.
The outer tube tube base 5 is a resin molded product, and an outer tube tube basic body 51 located on the central axis of the outer tube tube base 5 and a blade 52 formed by projecting outward from the basic body 51 in a symmetrical direction. The wing 52 is formed on the outer surface of the wing 52 by a projection 53 that is hooked on the engaging portion 222 of the outer needle base 2 and holds the outer tube 40 and the puncture needle 10 attached thereto. In order to release the lock, a space 54 is provided that allows the blade 52 to move in a direction close to the shaft.
The outer tube basic body 51 is connected to the tip of the outer tube 4 by bonding or via a connector so that the bending direction of the outer tube 4 is the same as the protruding direction on one side of the blade 52, The rear end side is formed as a female taper that fits with the male taper of the outer needle basic body 21 described above. The wings 52 are connected to the basic body 51 at the tip portion and the intermediate portion, and are formed so as to project outwardly in the symmetric direction, but each distance (L1, L1) from the central axis of the outer tube 40 to the outer surface of the wings L2) is different and is formed to be asymmetrical with respect to the central axis so that it can be mounted only in one direction when fitting with the puncture needle 10. In addition, a projection 53 is provided on the outer side of the wing 52 so as to be hooked on the locking portion 222 of the outer needle base 2 and hold the fitting between the puncture needle 10 and the outer tube 40. 53 is formed in an inclined shape (53a portion) so that it can be smoothly inserted in the direction of insertion into the outer needle base 2, and is not easily removed in the natural state in the direction of removal from the outer needle base 2. It is formed in the shape of a right-angled triangle that is perpendicular to the shape (shape that forms a corner) (53b portion). Further, the wing 52 is formed as a space 54 between the connecting portion at the tip portion and the intermediate portion with the basic body 51 described above, and the wing 52 is centered by pressing the gripping portion 55 on the outer surface of the wing 52 from both sides. A structure in which the outer tube 40 and the puncture needle 10 can be easily removed by detaching the protrusion 53 from the locking portion 222 by narrowing the interval between the protrusions 53 close to each other in the axial direction.
The outer tube 40 and the puncture needle 10 are integrated by inserting the outer needle 1 into the outer tube 4 and fitting and locking the outer tube base 5 and the outer needle base 2. The epidural needle.

As described above, the insertion of the puncture needle 10 into the outer tube 40 is performed by connecting the bending direction of the outer tube 4 and the connection direction of the outer tube tube base 5 and the blade surface direction of the outer needle 1 and the outer needle base 2. The puncture needle 10 is inserted into the outer tube 40 whose direction is accurately set, but the outer tube tube 4 and the outer needle tube 14 are aligned in the same direction so that the bending direction of the outer needle tube 4 and the Huber point 11 of the outer needle are the same. The wing 52 of the base 5 and the outer needle wing 23 of the outer needle base 2 are inserted perpendicularly, and the distal end of the outer tube 4 is inserted in a direction coinciding with the needle tube direction indicator 24 of the outer needle base 2. In this way, when the outer tube tube 4 and the Huber point 11 are inserted with the same curvature, the curve of the outer tube tube 4 is inserted into contact with the curve of the outer tube tube 4 and the cutting edge is inserted. Since it does not contact the tube, it is possible to prevent the outer cylindrical tube 4 from being broken or damaged by the cutting edge. The outer needle base 2 and the outer tube tube base 4 are fitted and attached. The male taper of the outer needle basic body 21 of the outer needle base 2 and the female of the outer tube tube basic body 51 of the outer tube tube base 5 are mounted. At the same time when the taper is fitted, the wing 52 of the outer tube base 5 and the outer tube basic body 51 are accommodated in the blade receiving hole 221 of the fitting receiving portion 22 and the outer needle blade 53, and the outer tube base The protrusions 53 provided on the wings 52 of the 5 are fixed by engaging with the engaging portions 222 of the outer needle base 2 and are fitted and locked so that they are not easily detached. At this time, the blade 52 of the outer tube tube base 5 is asymmetric with respect to the shaft, so that it is not connected to the opposite side.
On the other hand, detachment of the puncture needle 10 from the outer tube 40 is because the space 54 is formed in the outer tube base 5 as described above, so that the outer surface 55 of the wing 52 of the outer tube tube 5 is moved from both sides. By gripping, pressing toward the shaft side, and bringing the wings close to each other, the protrusion 53 provided on the wing 52 can be easily detached and detached from the locking portion 222 of the outer needle base 2.

Hereinafter, a method for introducing an epidural catheter using the epidural needle of the present invention will be confirmed.
1. The epidural needle according to the present embodiment (the state where the puncture needle 10 and the outer tube 40 are attached) is checked with the index 24 or the like to puncture from the set puncture point.
2. Next, the inner needle is removed, and the needle is inserted into the epidural space by the resistance disappearance method or the hanging drop method.
3. When the puncture into the epidural space is confirmed, the connection between the puncture needle 10 and the outer tube 40 is released by pressing the wing 52 and the outer tube 40 is advanced to the vicinity of the tip of the outer needle 1. Thereafter, the outer tube 1 is left and the outer needle 1 is removed.
4). Then, the epidural catheter is inserted from the outer tube base 5 through the outer tube 4 to a desired length. Here, a catheter withdrawal operation, which has been contraindicated in the past, is also possible, and by simply changing the direction of the outer tube 40, the catheter can be reinserted in a different direction without repuncturing. This is possible, and the catheter tip can be surely positioned at an optimal position.
5. When the catheter can be placed, the outer tube 40 is removed, the catheter is fixed to the body surface, and injection of anesthetic or the like is started.

  According to the epidural needle of the present invention, it is not limited to the catheter for continuous epidural anesthesia described above, and is used by being inserted into the epidural space, and can be inserted through the outer cylinder. It can be safely inserted into any device, and the stimulating electrode and epidracopy that are already inserted and used in the epidural space are improved and reduced to satisfy the conditions, or If newly developed instruments that satisfy the above conditions are developed in the future, the epidural needle with a sheath (outer cylinder) of the present invention can be used as an instrument for guiding them to the epidural space. Of course, these applications are within the scope of the present invention.

10. Puncture needle 1. Outer needle 11. Outer needle tip (Huber point)
2. Outer needle base 21. Outer needle basic body 22. Fitting receiving portion 221. Blade receiving hole 222. Locking portion 23. Outer needle wing 24. 2. Needle tube direction indicator Inner needle base 31. Groove (blade edge index)
40. Outer tube 4. Outer tube 41. End of outer cylinder 42. 4. Curved part Outer tube tube base 51. Outer tube basic body 52. Wings 53. Protrusion 54. Space 55. Wing side (grip)

Claims (4)

A puncture needle composed of an inner and outer double needle formed at the outer needle tip at the Huber point, and an outer tube made of a flexible resin brazed in a curved shape and slidably covering the outer needle of the puncture needle; In the dura mater needle constituted by the above, the outer needle base of the puncture needle and the outer tube base of the outer tube are only at specific positions where the direction of the curve of the outer tube and the curve of the outer needle tube is the same. A fitting locking part that is detachable and that does not easily disengage is provided , and the fitting locking part is provided with a locking means with an outer needle base provided on the outer tube tube base. And a fitting receiving portion that accommodates the outer tube tube base including the wing provided on the outer needle base, and the wing is formed to project outward from the outer tube in a symmetrical direction. Protrusions that hold the tube and puncture needle attached, and in a direction closer to the axis of the wing that releases the locking by the protrusions Epidural needle is characterized in that configured with a space for the rotatably. The locking means provided on the wing is formed as a protrusion that is inclined in the direction of insertion into the outer needle base and has a corner in the removal direction, and the fitting receiving part provided in the outer needle base has a corner of the protrusion. The epidural needle according to claim 1 , wherein the epidural needle is formed as a latching portion to be hung. The epidural epidermis according to any one of claims 1 to 2 , wherein by pressing the wing portion from both sides toward the central axis, the projection is detached from the locking portion, and the outer tube base and the outer needle base can be detached. needle. The wings, one of epidural needle of claims 1 to 3 is formed asymmetrically outer cylinder tube group as a central axis.

Images