WO2008082170A1

WO2008082170A1 - The epidural needle and the epidural device

Info

Publication number: WO2008082170A1
Application number: PCT/KR2007/006922
Authority: WO
Inventors: Sin-Bum Kang
Original assignee: Sin-Bum Kang
Priority date: 2006-12-29
Filing date: 2007-12-28
Publication date: 2008-07-10
Also published as: KR100777455B1; EP2120742A1

Abstract

Disclosed are an epidural needle used in epidural and an epidural device using the same. A tube is inserted in the needle used in epidural so that the frictional resistance of skin tissue can be minimized when performing a surgical operation and the skin tissue is prevented from intruding into the space formed between the needle and a catheter. A catheter position setter is arranged at the lower end of a needle fastener so that the catheter can be placed at an appropriate position in the needle when performing the surgical operation and the catheter can be fastened by the catheter position setter not to be released from the needle.

Description

Description THE EPIDURAL NEEDLE AND THE EPIDURAL DEVICE

Technical Field

[1] The present invention relates to an epidural needle used in an epidural procedure and an epidural device using the same, and more particularly, to an epidural needle and an epidural device, wherein a tube is inserted in the needle used in an epidural procedure so that the frictional resistance of skin tissue can be minimized when performing a surgical operation and the skin tissue is prevented from intruding into the space formed between the needle and a catheter, and wherein a catheter position setter is arranged at the lower end of a needle fastener so that the catheter can be placed at an appropriate position in the needle when performing the surgical operation and the catheter can be fastened by the catheter position setter so that it is not released from the needle.

[2]

Background Art

[3] Anesthesia means a loss of sensation, a loss of pain or the removal of bodily reactions that obstruct the proceeding of an operation. It is not an exaggeration to say that anesthesia has existed throughout human history. Since ether was used for general anesthesia in the sixteenth century, the science of anesthesia has continuously undergone remarkable development.

[4] In general, anesthesia, which encompasses the loss of sensation, the loss of pain and the removal of bodily reactions that obstruct the conduct of an operation, as described above, is called general anesthesia, and anesthesia, in which a portion of the body is anesthetized without causing a general loss of sensation, is called local or regional anesthesia.

[5] The epidural procedure related to the present invention represents a method in which a thin tube is inserted into an epidural space outside a dura mater surrounding a spinal cord, and a local anesthetic is injected into the epidural space to selectively block spinal nerves. Due to the clear physiological understanding and various utilizations of local anesthetics, currently, the epidural procedure is one of the most frequently used types of anesthesia.

[6] The epidural procedure has suffered from side effects in the past several years due to the use of a local anesthetic, which has a relatively high concentration, that is, in that severe motor blockade can occur and, as a portion of the drug used in the epidural is absorbed from the spinal cord into the entire human body, children and pregnant women can be harmed. However, recently, as a catheter, a spinal needle and a drug injection mechanism have been developed, and local anesthetics having low virulence and excellent effects and a method of injecting a drug agent into the extradural arachnoid have been developed, the above-described problems can be solved, and the epidural has been highlighted as a method of anesthesia providing excellent advantages.

[7] Nevertheless, even in the case in which the epidural procedure, as an excellent anesthetizing method, is used, serious disadvantages, which cannot be ignored, exist in conventional anesthetizing mechanisms for epidural procedure. Hereafter, a conventional anesthetizing mechanism and method used in the epidural procedure and the problems thereof will be described.

[8] Referring to FIG. 1, there is illustrated the structure of a spinal cord part where an epidural procedure is conducted. The spinal cord part through which the nerves of the human body pass, has a structure which is surrounded by several muscular fascia. That is to say, the spinal cord part has, starting from the outside, skin 901, an interspinous ligament 902, a ligamentum flavum 903, and a dura mater 904. A space of about 2 mm, which is located outside the dura mater 904, is called an epidural space 900, and a local anesthetic is injected into the epidural space 900.

[9] Since the epidural space 900 is an empty space in which a slight negative pressure is applied, if a needle reaches to the epidural space 900, the resistance applied to a syringe is abruptly decreased, and this signal serves as an important signal indicating that the needle has been positioned into the epidural space.

[10] If an anesthetic is injected before the needle reaches the epidural space 900, a desired anesthesia effect cannot be anticipated. Also, if the needle passes through the dura mater 904, severe pain is caused to a patient, and the possibility of infection increases. Therefore, in order to perform epidural, the sense of touch for perceiving when the needle passes through respective muscular fascias and the skill for sensing a phenomenon in which a pressure decreases when the end of the needle reaches the epidural space 900 are required.

[11] That is to say, in performing a surgical operation such as an operation or anesthesia, the sense of touch plays the most important role as the path of information. Thus, an anesthetist can be aware of the success and the proceeding of an operation through the senses of touch felt by the fingertips by the medium of implements. This is the most important factor for determining the skill of medical personnel. However, in order to have the skill, long-term experiences over a number of operations are required. Specifically, in the case of anesthesia and an operation performed using a syringe, since all manipulation is implemented relying on the sense of touch which is felt by the fingertips, the sense of touch is regarded as a very important factor even in the epidural anesthesia as described above. Nonetheless, there is a situation in which even unskilled personnel must conduct anesthesia. To this end, currently, in the related field, after an epidural needle 1 is pushed by a predetermined distance, by injecting saline solution which is harmless to the human body, using a syringe, it is checked whether the needle 1 reaches the epidural space 900. Detailed description regarding this will be given below.

[12] Referring to FIGs. 2 through 6, the implements used in the epidural anesthesia are illustrated.

[13] FIG. 2 illustrates an epidural needle 1 used in the epidural anesthesia, FIG. 3 illustrates a stylet 2, FIG. 4 illustrates a syringe coupler 3 which is provided to check whether the epidural needle 1 reaches the epidural space 900, FIG. 5 illustrates a catheter 4, and FIG. 6 illustrates a catheter connector 5.

[14] In the case of the epidural anesthesia, unlike the general anesthesia that uses an intubation tube, the epidural needle 1 is used. While various kinds of needles can be used as the epidural needle 1, in most cases, a Touhy needle, which has a curved end so as to prevent the inner ligament, etc. from being injured, is used.

[15] The stylet 2 is an implement which serves as a kind of a plug for preventing foreign substance such as tissue from intruding into the epidural needle 1 in the course of inserting the needle 1 into the epidural space 900.

[16] In the case that only the epidural needle 1 is inserted without using the stylet 2, since foreign substance can intrude into the epidural needle 1, it is difficult to properly insert the catheter 4 which will be described later in detail. While the stylet 2 is provided in a state in which it is initially inserted into the epidural needle 1, since the stylet 2 is then removed when the epidural needle 1 is inserted to a predetermined position, the stylet 2 can be considered as an unnecessary implement which is not needed so long as the catheter 4 is initially provided in a state in which it is inserted into the epidural needle 1.

[17] As described above, the syringe coupler 3 represents an implement which is needed to check whether the epidural needle 1 reaches the epidural space 900. In other words, in the case of an unskilled anesthetist, since it is difficult to be aware of whether the epidural needle 1 has reached the epidural space 900, first, after partly inserting the epidural needle 1 through the skin and the ligament, the syringe coupler 3 is coupled to the epidural needle 1, and a syringe filled with liquid substance such as saline solution which is harmless to the human body is coupled to the syringe coupler 3. Then, by gradually inserting the epidural needle 1 while injecting the liquid substance through the syringe little by little, it is possible to find the precise insertion position of the epidural needle 1.

[18] In this case, if the epidural needle 1 is inserted into the ligament, due to the characteristic of the ligament to which a positive pressure is applied, when injecting the liquid substance filled in the syringe, the injected substance flows back through the syringe coupler 3. On the other hand, if the epidural needle 1 is inserted into the epidural space 900, due to the characteristic of the epidural space 900 to which a negative pressure is applied, the injected substance does not flow back, and in this way, it is possible to find the precise insertion position of the epidural needle 1.

[19] After the epidural needle 1 is inserted to the precise position, the syringe coupler 3 is removed, and the catheter 4 is inserted through the epidural needle 1.

[20] The syringe coupler 3 is an unnecessary implement to a skilled anesthetist. Also, even in the case of an unskilled anesthetist who cannot easily find the precise position of the epidural space 900, if it is possible to find the position of the epidural space 900 through another way, the syringe coupler 3 can be regarded as an unnecessary implement which adds procedural complexities and has no reason for existence. Thus, if the syringe coupler 3 can be removed, unnecessary waste of man power can be prevented, costs can be saved, and the efficiency of the epidural anesthesia can be improved. Therefore, it cannot be mentioned that the conventional epidural device has no problems.

[21] The catheter 4 indicates a thin tube which is used to measure the discharge of liquid contents from the coelom (the pleural cavity and the peritoneal cavity) or fistular or saccular organs (such as the alimentary canal, the bladder, and so on) and which is made of rubber or metal. However, the catheter 4 also indicates an implement which can be applied in the injection of medicine or cleaning solution, differently from the original objects thereof. In the present invention, the catheter 4 means an implement which is provided for the injection of an anesthetic drug, and this applies in the same manner in the following description.

[22] Finally, after the insertion of the catheter 4 is completed, the epidural needle 1 is pulled along the catheter 4 and is removed. After the epidural needle 1 is removed, the end of the catheter 4 is inserted into the upper end of the catheter connector 5. Then, after removing the cap 5b of the catheter connector 5, by closing the cover 5 a of the catheter connector 5, the catheter 4 is fastened. Next, a syringe for an anesthetic drug is coupled to the catheter connector 5, and the anesthetic drug is injected. In these ways, the epidural anesthesia is conducted.

[23] Nevertheless, even in this procedure, when considering the length of the catheter 4 which is very long, it is not easy to pull the epidural needle 1 along the catheter 4, and the catheter 4 is likely to come into contact with a floor or a wall in the course of removing the epidural needle 1. Therefore, the removal of the epidural needle 1 must be carefully implemented.

[24] Namely, if the catheter 4 comes into contact with a floor or a wall, the meaning of the aseptic packaging of the catheter 4 can be deteriorated, and the possibility of bacterial infection increases. Therefore, irrespective of a medical situation in which the epidural anesthesia must be conducted, pus can be caused through bacterial infection. If pus is caused in the epidural space 900, the pus cannot be healed through simple treatment, and instead, the pus must necessarily be removed through an operation. Hence, the above-described problem becomes more serious. Also, when epidural anesthesia is conducted for painless labor, even though the least amount of bacterial infection occurs, because this can cause a fatal result to an embryo who does not have sufficient immunity, the problems of the conventional art are matters of grave concern.

[25] As a result, the epidural anesthesia is a complicated procedure which requires various implements, and must be conducted under the cooperation of several personnel. Aside from the procedural cumbersomeness such as of inserting and removing various implements, a number of dangerous factors are included in the conduct of the procedure. Also, when most simplifying the epidural anesthesia, even though only the catheter 4 is resultantly needed, in order to precisely insert the catheter 4 into the epidural space 900 and, through this, to inject a diluted local anesthetic, coupling and removal of various complicated implements is required. Therefore, if the epidural device can be simplified, the above-described problems can be solved.

[26] In particular, the possibility of the bacterial infection, which can occur in the course of conducting the epidural anesthesia, is a very important issue which must be most immediately addressed.

[27]

Disclosure of Invention

Technical Problem

[28] Accordingly, the present invention has been made in an effort to solve the problems occurring in the related art, and an object of the present invention is to provide an epidural needle which can be easily removed so that convenience is improved when a surgical operation is conducted, unnecessary waste of manpower is prevented, and the possibility of bacterial infection when removing the needle is decreased.

[29] Another object of the present invention is to provide an epidural device in which the epidural needle, a catheter and a catheter connector are integrally arranged, so that an epidural procedure can be simply and quickly performed, costs can be reduced and the possibility of bacterial infection can be decreased through the removal of unnecessary parts.

[30] Another object of the present invention is to provide an epidural device which allows even an unskilled doctor, who cannot precisely find the position of an epidural space, to easily and simply find the position of the epidural space.

[31] Still another object of the present invention is to provide an epidural device in which a tube is inserted into the needle so that the tube is prevented from being released from the needle in the course of inserting the needle through skin tissue when performing a surgical operation, the friction resistance of the skin tissue can be minimized in the course of inserting the needle through the skin tissue, and the skin tissue is prevented from intruding into the space formed between the needle and the catheter.

[32] A still further object of the present invention is to provide an epidural device which allows the catheter to be placed at an appropriate position in the needle when performing a surgical operation by locking a catheter position setter to the lower end of a needle fastener or by defining a groove in the needle fastener.

[33] In order to achieve the above objects, the present invention is realized as the embodiments having the following constructions.

[34]

[35]

Advantageous Effects

[36] Thanks to the features of the present invention, the present invention has the following effects.

[37] The present invention provides an epidural needle which can be easily removed, so that convenience is improved when implementing a surgical operation, unnecessary waste of manpower is prevented, and the possibility of bacterial infection when removing the needle is decreased.

[38] The present invention provides an epidural device in which the epidural needle, a catheter and a catheter connector are integrally arranged, so that an epidural procedure can be simply and quickly performed, costs can be reduced, and the possibility of bacterial infection can be decreased, thanks to the elimination of unnecessary parts.

[39] The present invention provides an epidural device which allows even an unskilled doctor, who cannot precisely find the position of an epidural space, to easily and simply find the position of the epidural space.

[40] In the present invention, due to the fact that a tube is inserted into the needle, the tube is prevented from being released from the needle in the course of inserting the needle through skin tissue when performing a surgical operation, the friction resistance of the skin tissue can be minimized in the course of inserting the needle through the skin tissue, and the skin tissue is prevented from intruding into the space formed between the needle and the catheter.

[41] In the present invention, the catheter can be placed at an appropriate position in the needle when performing a surgical operation by locking a catheter position setter to the lower end of a needle fastener or by defining a groove in the needle fastener. [42]

Brief Description of the Drawings

[43] FIG. 1 is a schematic view illustrating the structure of a spinal cord part where an epidural procedure is conducted;

[44] FIG. 2 is a perspective view of a conventional epidural needle;

[45] FIG. 3 is a perspective view of a conventional stylet;

[46] FIG. 4 is a perspective view of a conventional syringe coupler;

[47] FIG. 5 is a perspective view of a conventional catheter;

[48] FIG. 6 is a perspective view of a conventional catheter connector;

[49] FIG. 7 is an exploded perspective view of an epidural device of the present invention;

[50] FIG. 8 is a perspective view of the epidural device of the present invention;

[51] FIG. 9 is a perspective view of an epidural needle according to one embodiment of the present invention;

[52] FIG. 10 is a front view of the epidural needle;

[53] FIG. 11 is a perspective view illustrating a tube of the present invention;

[54] FIG. 12 is a perspective view illustrating another embodiment of a tube of the present invention; [55] FIG. 13 is an perspective view of the needle fastener according to one embodiment of the present invention; [56] FIG. 14 is a perspective view of a needle fastener according to another embodiment of the present invention; [57] FIG. 15 is an assembled perspective view of a needle fastener and a needle fastener wing according to another embodiment of the present invention; [58] FIG. 16 is a perspective view of a needle fastener according to another embodiment of the present invention; [59] FIG. 17 is a perspective view of a needle fastener according to still another embodiment of the present invention; [60] FIG. 18 is a perspective view of a catheter fastener according to one embodiment of the present invention; [61] FIG. 19 is a view illustrating an embodiment of the present invention for fixing the position of a catheter; [62] FIG. 20 is a view illustrating one embodiment for fastening a tube according to

FIG. 19; [63] FIG. 21 is a view illustrating another embodiment for fastening a tube according to

Fig. 19; [64] FIG. 22 is a view illustrating another embodiment of the present invention for fixing the position of a catheter;

[65] FIG. 23 is a view illustrating another embodiment for fastening a tube according to

FIG. 22;

[66] FIG. 24 is a view illustrating another embodiment for fastening a tube according to

FIG. 22;

[67] FIG. 25 is a view illustrating another embodiment for fastening a tube according to

FIG. 22;

[68] FIG. 26 is a view illustrating another embodiment for fastening a tube according to

FIG. 22;

[69] FIG. 27 is a view illustrating still another embodiment of the present invention for setting the position of a catheter;

[70] FIG. 28 is a view illustrating another embodiment for fastening a tube according to

FIG. 27;

[71] FIG. 29 is a view illustrating another embodiment for fastening a tube according to

FIG. 27;

[72] FIG. 30 is a view illustrating another embodiment for fastening a tube according to

FIG. 27; and

[73] FIG. 31 is a view illustrating another embodiment for fastening a tube according to

FIG. 27.

[74]

[75]

[76]

Mode for the Invention

[77] Below, the applicant will explain the embodiments of the present invention with reference to the attached drawings.

[78] Referring to FIGs. 7 and 8, an epidural device 1000 in accordance with one embodiment of the present invention is prepared in a state in which an epidural needle 100, a tube 300 inserted into the needle 100, a needle fastener 500, a needle fastener wing 600, a catheter 700, and a catheter fastener 800 are integrally assembled with one another.

[79] In order to indicate the difference between the present invention and the conventional art, an epidural needle according to the conventional art is denoted by the reference numeral 1, and an epidural needle according to one embodiment of the present invention is denoted by the reference numeral 100. Also, a catheter according to the conventional art is denoted by the reference numeral 4, and a catheter according to one embodiment of the present invention is denoted by the reference numeral 700.

[80] Also, since the epidural needle 100, the tube 300, the needle fastener 500 and the catheter fastener 800 must be provided in a state in which the catheter 700 is inserted through them, the respective members should include hollow cylindrical sectional shapes therein, but an explanation of this will be omitted in the following description.

[81] Referring to FIGs. 9 and 10, the epidural needle 100 has a needle body 101, a curved portion 103, and a needle cutaway opening 105. The lower end of the needle body 101 includes a thread 109.

[82] The needle body 101 has a space, defined therein, for inserting the catheter 700.

While the needle body 101 has a hollow cylindrical shape when viewed in its entirety, since the needle cutaway opening 105 is defined on a side of the needle body 101, the needle body 101 has a hollow cylindrical shape, in which a side thereof is cut away, as shown in the drawings.

[83] The curved portion 103 serves as a component element, which is included to prevent ligaments, etc. from being injured when inserting the epidural needle 100 into the epidural space 900 (see FIG. 1). The curved portion 103 has the exact shape of a Touhy needle.

[84] The needle cutaway opening 105 is adopted to allow the epidural needle 100 to be easily separated from the tube 300 surrounding the catheter 700. As shown in the drawings, the needle cutaway opening 105 is defined by the fact that a side of the epidural needle 100 is cut away from the upper end to the lower end of the epidural needle 100. In order to prevent the skin tissue from intruding into the needle cutaway opening 105, it is preferred that the needle cutaway opening 105 be defined on the inner side of the epidural needle 100.

[85] The width of the needle cutaway opening 105 is determined depending upon the size of the tube 300. As will be described later in the exemplary use of the epidural device 1000, it is preferred that the width of the needle cutaway opening 105 be determined to ensure that excessive force is not applied to the epidural needle 100 when separating the epidural needle 100 from the tube 300 after the catheter 700 is inserted into the epidural space 900.

[86] Further details regarding this will be mentioned later in the description of the exemplary use of the epidural device according to the present invention.

[87] The thread 109 serves as a component element which is added to improve convenience when coupling and decoupling the epidural needle 100 and the needle fastener 500 to and from each other. It is possible to adopt any ways for improving convenience when coupling and decoupling the epidural needle 100 and the needle fastener 500 to and from each other.

[88] In this regard, referring to FIG. 10, it is to be appreciated that, according to another embodiment of the present invention, a frusto-conical portion 107 is formed on the lower end of the needle body 101 in place of the thread 109. In this case, the epidural needle 100 and the needle fastener 500 are coupled to each other through press-fitting, as is well known in the art.

[89] Further, in place of the frusto-conical portion 107 formed on the lower end of the needle body 101, a frusto-conical portion 513 can be formed on a needle fastening part 501 of the needle fastener 500, which will be described later in detail, and this is illustrated in FIG. 15.

[90] Referring to FIG. 11, the tube 300 is composed of a hollow cylindrical member.

[91] Since the tube 300 is a member which is inserted into the needle body 101, considering that the tube 300 is inserted up to the epidural space 900 as it is, it is preferred that the tube 300 be made of a material having constituents which are harmless to the human body, such as clear PVC, siliconized PVC or clear polyurethane.

[92] Also, referring to FIG. 7, since the length of the tube 300 is determined such that the tube 300 is inserted not through the entire needle body 101 but partially into the needle body 101, considering the functions of the curved portion 103 and the thread 109 or the frusto-conical portion 107, while it is preferred that the tube 300 extend from the starting point of the curved portion 103 to the starting point of the thread 109 or the frusto-conical portion 107, otherwise, the tube 300 can extend beyond the thread 109 or the frusto-conical portion 107.

[93] Therefore, when the tube 300 is inserted into the needle 100, it is possible to solve the problems which are caused in the course of inserting the needle 100 through the skin tissue, that is, problems in which the tube 300 is pushed out of the needle 100 by the resistance of the skin tissue, due to which it is difficult to insert the needle 100. Further, since the tube 300 can fill the space which may be present between the needle 100 and the catheter 700, it is possible to prevent skin tissue, etc. from intruding into the space in the course of performing a surgical operation.

[94] In accordance with another embodiment of the present invention, as shown in FIG.

12, the tube 300 can additionally have perforated lines 301 and an opening tab 303.

[95] In the case of the tube 300 shown in FIG. 11, after the needle 100 is removed, the tube 300 remains fastened to the needle fastener 500, or is simply placed around the catheter 700. However, in the case of the tube 300 shown in FIG. 12, after the needle 100 is removed, by grasping and pulling the opening tab 303 along the perforated lines 301, the tube 300 can be easily removed from the catheter 700.

[96] The perforated lines 301 and the opening tab 303 serve as component elements provided to allow the tube 300 to be easily removed. While two perforated lines 301 are shown in the drawing, it is to be appreciated that one, or three or more, perforated lines 301 can of course be formed.

[97] Referring to FIG. 15, the needle fastener wing 600 is illustrated in a state in which it is coupled to the needle fastener 500.

[98] Referring to FIG. 14, the needle fastener 500 includes a needle fastening part 501, a first flange 503, a wing coupling part 505, a second flange 507, and a catheter fastener coupling part 509.

[99] The needle fastening part 501 is a part into which the needle body 101 is inserted.

In the case in which the needle body 101 has the thread 109 in the lower end thereof, a corresponding thread 519 is formed in the needle fastening part 501. If the needle body 101 is coupled to the needle fastening part 501 through press-fitting, as described above, the thread 519 can be omitted.

[100] Also, in order to improve convenience when coupling the needle body 101 and the needle fastening part 501 to each other, a frusto-conical portion 513 can be formed in the needle fastening part 501, and this is illustrated in FIG. 14.

[101] In this case, the size of the frusto-conical portion 513 must be determined depending upon the insertion distance of the needle body 101.

[102] The first flange 503, the wing coupling part 505 and the second flange 507 are component elements which are included to couple the needle fastener 500 and the needle fastener wing 600 to each other. The first flange 503 is enlarged at the lower end of the needle fastening part 501, extends in a diametrical direction, and has the shape of a plate. The wing coupling part 505 decreases in size on the lower surface of the first flange 503, extends in an axial direction, and has a hollow cylindrical shape for permitting the passage of the catheter 700. The second flange 507 is enlarged again at the lower end of the wing coupling part 505, extends in the diametrical direction, and has the shape of a plate.

[103] As a result, the needle fastener wing 600 is coupled to the needle fastener 500 in such a way as to be fitted into the wing coupling part 505. In order to prevent the needle fastener wing 600, coupled to the needle fastener 500, from fluctuating, it is preferred that the distance between the first flange 503 and the second flange 507, that is, the length of the wing coupling part 505, be the same as the thickness of the needle fastener wing 600.

[104] The catheter fastener coupling part 509 has a thread 520 formed in the outer surface thereof. The thread 520 is formed to allow the needle fastener 500 to be coupled to the catheter fastener 800 after performing a surgical operation.

[105] Referring to FIG. 16, in accordance with another embodiment of the present invention, the needle fastener 500 further includes a needle fastener cutaway opening 517 and a needle fastener cover 515.

[106] The needle fastener cutaway opening 517 (which is defined at the same position as the needle fastener cover 515 in the drawing) is formed by the fact that a side of the needle fastener 500 is cut away. The needle fastener cutaway opening 517 extends all the way from the upper end to the lower end of the needle fastener 500. The needle fastener cutaway opening 517 is defined when it is desired to completely separate the needle fastener 500 from the catheter 700, that is, when the needle fastener 500 and the catheter fastener 800 need not be coupled to each other.

[107] The needle fastener cover 515 serves as a member for filling the needle fastener cutaway opening 517. If there is no possibility of the catheter 700 being released through the needle fastener cutaway opening 517 in the course of conducting an epidural procedure, the needle fastener cover 515 can be omitted.

[108] The needle fastener cover 515 can include an opening tab or perforated lines.

[109] Referring to FIG. 17, in accordance with another embodiment of the present invention, the needle fastener 500 further includes a syringe coupling part 511.

[110] The syringe coupling part 511 is formed on a side of the catheter fastener coupling part 509. The syringe coupling part 511 serves as a component element, which is needed for confirming whether the epidural needle 100 is precisely positioned in the epidural space 900. The syringe coupling part 511 has a hollow cylindrical shape, such that, after a syringe is coupled to the syringe coupling part 511, the fluid in the syringe can be injected.

[I l l] Considering that a skilled doctor can find the position of the epidural space using only the sense of touch, the syringe coupling part 511 can be omitted.

[112] Referring to FIG. 22, in accordance with another embodiment of the present invention, the needle fastener wing 600 has the shape of a plate and is defined with an engagement groove 602 in the center portion thereof.

[113] The engagement groove 602 is defined to allow the needle fastener wing 600 to be fitted with the wing coupling part 505. The engagement groove 602 has a size which is determined depending upon the size of the wing coupling part 505.

[114] Since the needle fastener wing 600 is a component element serving as a kind of handle which is provided to improve convenience when coupling the syringe and the syringe coupling part 511 to each other and injecting the fluid through the syringe, the needle fastener wing 600 can be omitted.

[115] The catheter fastener 800 is a member into which the other end of the catheter 700 is inserted and fastened. The function of the catheter fastener 800 is partially redundant with that of the conventional catheter connector 5 mentioned above, in the catheter fastener 800 according to the present invention, but unlike the conventional catheter connector 5, the other end of the catheter 700 is fastened to the catheter fastener 800 at the outset.

[116] In the present invention, since the needle 100 can be removed from the catheter 700 through the needle cutaway opening 105 of the needle 100, the other end of the catheter 700 can be integrally formed with the catheter fastener 800. As a result, it is possible to originally prevent the other end of the catheter 700 from coming into contact with a floor, a wall or the clothes of a doctor or a nurse in the course of removing the needle 100, which could cause infection.

[117] Referring to FIG. 18, the catheter fastener 800 includes a catheter fastener body

801, a catheter fastener cover 803, and a catheter fastener cap 805.

[118] The catheter fastener body 801 has a thread 807 formed in the upper end thereof to be coupled with a catheter position setter 530. When the catheter faster 800 is coupled with the catheter position setter 530 through press-fitting, as described above, the thread 807 can be omitted.

[119] The catheter fastener cover 803 performs the same function as the cover 5a shown in FIG. 6. In the present invention, considering that the catheter 700 can be prepared in a state in which it is already inserted into the catheter fastener 800, the catheter fastener cover 803 can be omitted.

[120] The catheter fastener cap 805 is provided to permit the injection of diluted local anesthetic after the catheter 700 is precisely inserted into the epidural space 900. When the insertion of the catheter 700 is completed, an epidural procedure is performed in a manner such that the catheter fastener cap 805 is removed, a syringe for the injection of the local anesthetic is coupled to the catheter 700, and the local anesthetic is injected through the catheter 700.

[121] Hereinbelow, the coupling relationships and the sequence and method of use of the epidural device 1000 in accordance with one embodiment of the present invention will be described.

[122] First, referring to FIGs. 7 and 8, before performing an epidural procedure, the epidural device 1000 in accordance with an embodiment of the present invention must be prepared.

[123] In this case, the epidural needle 100 is provided in a state in which the lower end thereof is inserted into the needle fastening part 501 of the needle fastener 500. The catheter 700 has one end which is inserted through the epidural needle 100 and the needle fastener 500 and the other end which is fastened to the catheter fastener 800.

[124] Next, after the epidural device 1000 is prepared, the epidural needle 100 is pushed up to the precise position in the epidural space 900.

[125] At this time, although the syringe coupling part 511 is not needed in the case of a skilled doctor, as mentioned above, in the case of an unskilled doctor, a syringe filled with saline solution is coupled to the syringe coupling part 511, and the epidural needle 100 is inserted up to the epidural space 900 while injecting the saline solution a little at a time.

[126] When performing the surgical operation, in order to prevent skin tissue from intruding into the needle 100, the tube 300 is inserted into the needle 100. [127] After the epidural needle 100 is precisely inserted up to the epidural space 900, the catheter 700 is pushed little by little and the epidural needle 100 is pulled little by little, such that only the catheter 700 can be positioned in the epidural space 900.

[128] After the epidural needle 100 is pulled such that the epidural needle 100 is completely separated from the skin 901, the epidural needle 100 is removed from the needle fastening part 501 of the needle fastener 500 (by rotating the epidural needle 100 when the epidural needle 100 has the thread 109 or by pulling out the epidural needle 100 when the epidural needle 100 is coupled to the needle fastening part 501 through press-fitting). Then, the epidural needle 100 is separated through the cutaway opening 105 defined in the needle 100, from the tube 300 which surrounds a portion of the catheter 700.

[129] As described above, after the separation of the needle 100 is completed, the needle fastener wing 600, which is coupled to the needle fastener 500, is pulled along the catheter 700, and the needle fastener 500 is coupled to the catheter fastener 800 by the thread 520, which is formed in the catheter fastener coupling part 509 of the needle fastener 500, so that the needle fastener wing 600 can be used as a handle when injecting a local anesthetic.

[130] Hereafter, other embodiments of the present invention will be described with reference to the attached drawings.

[131] FIG. 19 illustrates one embodiment in which the position of the catheter 700 is fixed. In this embodiment, a groove 522 is additionally defined on the inner surface of the catheter fastener coupling part 509 formed on the lower end of the needle fastener 500.

[132] The groove 522 is to fix the position of the catheter 700. After one end of the catheter 700 is inserted up to a predetermined position inside the needle 100, by fitting a portion of the catheter 700 into the groove 522 and thereby fastening the catheter 700, the position of the catheter 700 is fixed.

[133] By this fact, one end of the catheter 700, which is inserted into the needle 100, is prevented from moving in the course of inserting the needle 100 through the skin tissue.

[134] FIG. 20 illustrates another embodiment in which the position of the tube 300 is fixed in the embodiment shown in FIG. 19. In this embodiment, a groove 524 is additionally defined on the inner surface of the needle fastening part 501, which is formed on the upper end of the needle fastener 500.

[135] The groove 524 serves to fix the position of the tube 300. After an adhesive A is applied on the outer surface of the tube 300, the tube 300 is inserted into the groove 524 to be integrated with the needle fastener 500. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also moved out of the needle 100 together with the needle fastener 500 and is locked to the catheter fastener 800.

[136] FIG. 21 illustrates another embodiment in which the position of the tube 300 is fixed in the embodiment shown in FIG. 19. In this embodiment, a groove 524, which has a diameter less than the outer diameter of the tube 300, is defined on the inner surface of the needle fastening part 501, which is formed on the upper end of the needle fastener 500, such that the tube 300 can be press-fitted into the groove 524. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also moved out of the needle 100 together with the needle fastener 500, and is locked to the catheter fastener 800. Otherwise, in the case where the perforated lines 301 are formed on one side of the tube 300, by releasing the tube 300 from the groove 524 and by grasping and pulling the opening tab 303 along the perforated lines 301 to cut away a portion of the tube 300, the tube 300 can be separated from the catheter 700.

[137] FIG. 22 illustrates another embodiment in which the position of the catheter 700 is fixed. In this embodiment, a conventional catheter guider 10, which has a coupling part 11 to be coupled to the catheter fastener coupling part 509 formed on the needle fastener 500 and is defined with a guide hole 13 for guiding the catheter 700, is provided, and a groove 15 is additionally defined on the inner surface of the lower end of the catheter guider 10 which defines the guide hole 13 through which the catheter 700 is inserted.

[138] The groove 15 serves to fix the position of the catheter 700. After fitting the guider

10 into the catheter fastener coupling part 509 and inserting one end of the catheter 700 through the guide hole 13 defined in the guider 10 up to a predetermined position inside the needle 100, by fitting the other end of the catheter 700 into the groove 15 and thereby fastening the catheter 700, the position of the catheter 700 is fixed.

[139] Thanks to this fact, one end of the catheter 700, which is inserted into the needle

100, is prevented from moving in the course of inserting the needle 100 through the skin tissue.

[140] FIG. 23 illustrates another embodiment in which the position of the tube 300 is fixed in the embodiment shown in FIG. 22. In this embodiment, a groove 524 is additionally defined on the inner surface of the needle fastening part 501, which is formed on the upper end of the needle fastener 500.

[141] The groove 524 serves to fix the position of the tube 300. After an adhesive A is applied on the outer surface of the tube 300, the tube 300 is inserted into the groove 524 to be integrated with the needle fastener 500. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also moved out of the needle 100 together with the needle fastener 500, and is locked to the catheter fastener 800.

[142] FIG. 24 illustrates another embodiment in which the position of the tube 300 is fixed in the embodiment shown in FIG. 22. In this embodiment, a groove 524, which has a diameter less than the outer diameter of the tube 300, is defined in the inner surface of the needle fastening part 501, which is formed on the upper end of the needle fastener 500, such that the tube 300 can be press-fitted into the groove 524. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also moved out of the needle 100 together with the needle fastener 500 and is locked to the catheter fastener 800. Otherwise, in the case that the perforated lines 301 are formed on one side of the tube 300, by releasing the tube 300 from the groove 524 and by grasping and pulling the opening tab 303 along the perforated lines 301 to cut away a portion of the tube 300, the tube 300 can be separated from the catheter 700.

[143] FIG. 25 illustrates another embodiment, in which the position of the tube 300 is fixed in the embodiment shown in FIG. 22. In this embodiment, a groove 17 is additionally defined in the coupling part 11, which is formed on the guider 10.

[144] The groove 17 is to fix the position of the tube 300. After an adhesive A is applied on the outer surface of the tube 300, which has one end extending into the groove 17, the tube 300 is inserted into the groove 17 and is integrated with the needle fastener 500. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also locked to the catheter fastener 800 together with the needle fastener 500.

[145] FIG. 26 illustrates another embodiment in which the position of the tube 300 is fixed in the embodiment shown in FIG. 22. In this embodiment, a groove 17, which has a diameter less than the outer diameter of the tube 300, is defined in the coupling part 11, which is formed on the guider 10, such that the tube 300 can be press-fitted into the groove 17. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also moved out of the needle 100 together with the needle fastener 500 and is locked to the catheter fastener 800. Otherwise, in the case that the perforated lines 301 are formed in one side of the tube 300, by releasing the tube 300 from the groove 17 and by grasping and pulling the opening tab 303 along the perforated lines 301 to cut away a portion of the tube 300, the tube 300 can be separated from the catheter 700.

[146] FIG. 27 illustrates another embodiment in which the position of the catheter 700 is fixed. In this embodiment, a catheter position setter 530 is additionally provided.

[147] The catheter position setter 530 includes a setter body 531 and a cover 533.

[148] The setter body 531 has a center hole through which the catheter 700 can pass. The setter body 531 has, on the front end thereof, a thread 539 into which the catheter fastener coupling part 509 of the needle fastener 500 is inserted, and, on the rear end thereof, a cap 535, which can be coupled with the catheter fastener 800.

[149] The cap 535 is formed with a thread 537 in the outer surface thereof. The cap 535 can be coupled to the catheter fastener 800 through the thread 537.

[150] However, the setter body 531 is not necessarily required to have the cap 535. Also, of course, coupling means other than the thread 537, for example, press-fitting, as mentioned above, can be adopted.

[151] In the catheter position setter 530, after a predetermined length of the catheter 700 is inserted into the needle 100 through the lower end of the cap 535 with the cover 533 opened, by closing the cover 533, the cover 533 squeezes the catheter 700 and fixes the position of the catheter 700.

[152] The thread 537 is formed in the circumferential outer surface of the cap 535 to allow the needle fastener 500 to be coupled to the catheter fastener 800 after the surgical operation is completed.

[153] Describing the functioning of the epidural device 1000 in accordance with the present embodiment of the present invention, which is additionally provided with the catheter position setter 530, before performing an epidural procedure, the epidural device 1000 is prepared. The epidural needle 100 is provided in a state in which the lower end thereof is inserted into the needle fastening part 501 of the needle fastener 500. The catheter 700, which is inserted through the epidural needle 100 and the needle fastener 500, is fastened by the catheter position setter 530, which is coupled to the lower end of the needle fastener 500, and is thereby fixed at an appropriate position inside the needle 100. The other end of the catheter 700 is coupled to the catheter fastener 800.

[154] Next, after the epidural device 1000 is prepared, the epidural needle 100 is pushed up to the precise position in the epidural space 900.

[155] At this time, the catheter 700 is fastened by the catheter position setter 530 and is held at the appropriate position in the needle 100, and the tube 300, which surrounds the catheter 700 and prevents the skin tissue from intruding into the needle 100 while the surgical operation is performed, is inserted into the needle 100.

[156] After the epidural needle 100 is precisely inserted up to the epidural space 900, the cover 533 of the catheter position setter 530 fastening the catheter 700 is opened. Then, the catheter 700 is pushed little by little and the epidural needle 100 is pulled little by little, such that only the catheter 700 is positioned in the epidural space 900.

[157] After the epidural needle 100 is pulled such that the epidural needle 100 is completely separated from the skin 901, the epidural needle 100 is removed from the needle fastening part 501 of the needle fastener 500 (by rotating the epidural needle 100 when the epidural needle 100 has the thread 109 or by pulling out the epidural needle 100 when the epidural needle 100 is coupled to the needle fastening part 501 through press-fitting). Then, the epidural needle 100 is separated through the cutaway opening 105 defined in the needle 100, from the catheter 700 and the tube 300, which surrounds a portion of the catheter 700.

[158] As described above, after the separation of the needle 100 is completed, if the tube

300 as shown in FIG. 12 is used, by grasping and pulling the opening tab 303 along the perforated lines 301 to cut away a portion of the tube 300, the tube 300 can be separated from the catheter 700. Otherwise, if the tube 300 as shown in FIG. 11 is used, by moving the tube 300 rearward on the catheter 700, the tube 300 can be fitted into the needle fastener 500, or can be simply held on the catheter 700.

[159] Of course, the tube 300 can be moved together with the needle fastener 500, and can be fastened to the catheter fastener 800 as shown in FIGs. 20, 21, and 23 through 26.

[160] Then, the needle fastener wing 600, which is coupled to the needle fastener 500, is pulled onto the catheter 700, and the catheter position setter 530, locked to the catheter fastener coupling part 509 of the needle fastener 500, is coupled to the catheter fastener 800, so that the needle fastener wing 600 can be used as a handle when injecting a local anesthetic.

[161] FIG. 28 illustrates another embodiment in which the position of the tube 300 is fixed in the embodiment shown in FIG. 27. In this embodiment, a groove 524 is additionally defined in the inner surface of the needle fastening part 501, which is formed on the upper end of the needle fastener 500.

[162] After an adhesive A is applied in the groove 524 of the needle fastening part 501, which is formed on the upper end of the needle fastener 500, the tube 300 is inserted into the groove 524 and is integrated with the needle fastener 500. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also locked to the catheter fastener 800 together with the needle fastener 500.

[163] FIG. 29 illustrates another embodiment in which the position of the tube 300 is fixed in the embodiment shown in FIG. 27. In this embodiment, a groove 524, which has a diameter smaller than the outer diameter of the tube 300, is defined in the inner surface of the needle fastening part 501 which is formed on the upper end of the needle fastener 500, such that the tube 300 can be press-fitted into the groove 524. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also locked to the catheter fastener 800 together with the needle fastener 500. Otherwise, in the case where the perforated lines 301 are formed in one side of the tube 300, by releasing the tube 300 from the groove 524 and by grasping and pulling the opening tab 303 along the perforated lines 301 to cut away a portion of the tube 300, the tube 300 can be separated from the catheter 700.

[164] FIG. 30 illustrates another embodiment in which the position of the tube 300 is fixed in the embodiment shown in FIG. 27. In this embodiment, a groove 541 is additionally defined on the upper end of the catheter position setter 530.

[165] After an adhesive A is applied in the groove 541 defined in the catheter position setter 530, the tube 300 is inserted into the groove 541 to be integrated with the catheter position setter 530. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also locked to the catheter fastener 800, together with the needle fastener 500.

[166] FIG. 31 illustrates another embodiment in which the position of the tube 300 is fixed in the embodiment shown in FIG. 27. In this embodiment, a groove 541, which has a diameter less than the outer diameter of the tube 300, is defined in the upper end of the catheter position setter 530, such that the tube 300 can be press-fitted into the groove 541. After the surgical operation is completed, when the needle fastener 500 is locked to the catheter fastener 800, the tube 300 is also moved out of the needle 100 together with the needle fastener 500, and is locked to the catheter fastener 800. Otherwise, in the case where the perforated lines 301 are formed in one side of the tube 300, by releasing the tube 300 from the groove 541 and by grasping and pulling the opening tab 303 along the perforated lines 301 to cut away a portion of the tube 300, the tube 300 can be separated from the catheter 700.

[167] Although preferred embodiments of the present invention have been described for illustrative purposes, those skilled in the art will appreciate that various modifications, additions and substitutions are possible, without departing from the scope and spirit of the invention as disclosed in the accompanying claims.

[168]

[169]

[170]

[171]

Claims

[I] An epidural device comprising: an epidural needle including a needle body having a hollow cylindrical shape, the needle body having a curved portion on an upper end thereof and a needle cutaway opening defined in a side thereof; a needle fastener coupled with the needle body; a catheter having one end which is inserted through the needle and the needle fastener; a catheter fastener to which another end of the catheter is integrally fastened; and a tube inserted into the needle to protect the catheter and prevent skin tissue from intruding into a space formed between the needle and the catheter. [2] The epidural device according to claim 1, wherein the tube has perforated lines and an opening tab. [3] The epidural device according to claim 1, wherein the catheter fastener includes a catheter fastener body, into and to which the catheter is inserted and fastened, and a catheter fastener cover which fastens the catheter. [4] The epidural device according to claim 1, wherein the needle body and the needle fastener have threads. [5] The epidural device according to claim 1, wherein the needle body has a frusto- conical portion formed on an end thereof. [6] The epidural device according to claim 5, wherein the needle fastener has a frusto-conical portion formed on an end thereof. [7] The epidural device according to any one of claims 4 to 6, wherein the needle fastener has a needle fastener cutaway opening which is defined in a side of the needle fastener. [8] The epidural device according to claim 1, wherein the needle fastener further has a syringe coupling part which allows fluid to be injected so as to find a precise position of an epidural space. [9] The epidural device according to claim 1, wherein a groove is additionally defined in an inner surface of a lower end of the needle fastener such that the catheter can be fitted into the groove to be fixed in a position thereof. [10] The epidural device according to claim 9, wherein the tube in integrated with the needle fastener.

[I I] The epidural device according to claim 9, wherein a groove, which has a diameter less than an outer diameter of the tube, is defined in an upper end of the needle fastener such that the tube is press-fitted into the groove.

[12] The epidural device according to claim 1, further comprising: a catheter guider inserted into the lower end of the needle fastener and having a groove which is defined in an inner surface of a guide hole such that the catheter is fitted into the groove. [13] The epidural device according to claim 12, wherein the tube in integrated with the needle fastener. [14] The epidural device according to claim 12, wherein a groove, which has a diameter less than an outer diameter of the tube, is defined in an upper end of the needle fastener such that the tube is press-fitted into the groove. [15] The epidural device according to claim 12, wherein the tube is integrated with the catheter guider. [16] The epidural device according to claim 12, wherein a groove, which has a diameter less than an outer diameter of the tube, is defined in the catheter guider such that the tube is press-fitted into the groove. [17] The epidural device according to claim 1, further comprising: a catheter position setter for holding a position of the catheter, one end of which is inserted into the needle, while the needle is inserted through skin tissue. [18] The epidural device according to claim 17, wherein the catheter position setter has a setter body through which the catheter is inserted and which is locked to the needle fastener or the catheter fastener, and a cover which fastens the catheter. [19] The epidural device according to claim 17, wherein the tube is integrated with the needle fastener. [20] The epidural device according to claim 17, wherein a groove, which has a diameter less than an outer diameter of the tube, is defined on an upper end of the needle fastener such that the tube is press-fitted into the groove. [21] The epidural device according to claim 17, wherein the tube extends to the catheter position setter and is integrated with the catheter position setter. [22] The epidural device according to claim 17, wherein a groove, which has a diameter less than an outer diameter of the tube, is defined on an upper end of the catheter position setter such that the tube is press-fitted into the groove.