HK1237291B - Injection needle - Google Patents
Injection needle Download PDFInfo
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- HK1237291B HK1237291B HK17111393.1A HK17111393A HK1237291B HK 1237291 B HK1237291 B HK 1237291B HK 17111393 A HK17111393 A HK 17111393A HK 1237291 B HK1237291 B HK 1237291B
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Description
本申请是2009年10月21日提交的优先权日为2008年10月28日的申请号为200910206725.5的名称为“注射针”的发明专利申请的分案申请。The present application is a divisional application of the invention patent application entitled “Injection Needle” with application number 200910206725.5 filed on October 21, 2009 and with priority date of October 28, 2008.
技术领域Technical Field
本发明涉及一种用于在人体或动物体组织中注射药品的注射针。The present invention relates to an injection needle for injecting medicine into human or animal body tissue.
背景技术Background Art
在特定外科手术期间以及在牙科治疗期间,必须对病人施以局部麻醉剂。这种麻醉只限于目标区域,并且在牙科治疗的情况下,这种麻醉应该限于将被处理的牙齿。通常,通过注射到将被麻醉的组织中来施加麻醉剂产品。During certain surgical procedures and dental treatments, patients must be given a local anesthetic. This anesthesia is limited to the target area, and in the case of dental treatment, it should be limited to the tooth being treated. Typically, the anesthetic product is administered by injection into the tissue to be anesthetized.
在人或动物的皮肤病治疗期间,有时需要被设计为以更安全且更小疼痛的方式进行注射的针。During the treatment of skin diseases in humans or animals, there is sometimes a need for needles designed to perform injections in a safer and less painful manner.
此外,在牙科治疗期间,通过在牙龈中进行麻醉剂产品的注射,以在外围软组织中产生效果。因此,需要可通过其尽可能精确地到达指定麻醉位置的针,从而能够限制被施加的麻醉剂产品的量。Furthermore, during dental treatment, anesthetic products are injected into the gums to produce an effect in the surrounding soft tissues. Therefore, a needle is required that can reach the desired anesthesia site as precisely as possible, thereby limiting the amount of anesthetic product administered.
然而,与呈现给病人的烦恼无关,麻醉剂的效果也并不总是最佳,这是因为麻醉剂产品部分地以与将被处理的牙齿有一定距离地进行分布而不是保留集中在其中。此外,注射针通常会偏移,因为在刺入组织(尤其是软组织)时会变形。However, regardless of the annoyance presented to the patient, the effect of the anesthetic is not always optimal, since the anesthetic product is partially distributed at a distance from the tooth to be treated rather than remaining concentrated therein. In addition, the injection needle often deflects because it deforms when penetrating tissue, especially soft tissue.
实际上,根据本发明的针主要用于施加麻醉剂产品,但此外还用于其它应用,例如皮肤病应用,其问题是在人体或动物体适当指定的位置沉积药品。In practice, the needle according to the invention is primarily used for applying anesthetic products, but is also used for other applications, such as dermatological applications, where the problem is to deposit the drug product at a well-defined location on the human or animal body.
在不同的麻醉技术中,本发明尤其关注在牙科手术中进行的韧带内麻醉(intraligamentary anesthesia)和Troncular麻醉。Among the different anesthesia techniques, the present invention is particularly concerned with intraligamentary anesthesia and troncular anesthesia performed during dental surgery.
韧带内麻醉包括将麻醉剂产品注射进入将被处理的牙齿周围的韧带中。利用传统针通过韧带内麻醉所引起的问题是使针充分深地刺入韧带的难度。即使利用最细的针,这还经常引起麻醉剂的泄漏。为了找到该问题的解决方法,医生试图更深地推进他/她的针,但很多次针都发生弯曲。从而,不得不更换针并重新刺入。Intraligament anesthesia involves injecting an anesthetic product into the ligament surrounding the tooth being treated. A problem with using a traditional needle for intraligament anesthesia is the difficulty of inserting the needle deeply enough into the ligament. Even with the thinnest needles, this often results in leakage of the anesthetic. To address this issue, doctors attempt to push their needle deeper, but the needle often bends, necessitating a needle replacement and reinsertion.
Troncular麻醉是在进入牙齿通道(dental channel)之前的低位牙神经的麻醉技术。在将针刺入软组织的期间,尤其在Troncular麻醉或局部麻醉期间,针被推进的十分深。在其刺入期间,传统针发生变形,紧接着导致弯曲的轨迹,这使得不能够在预期位置正确地执行注射。这是不可忽略的失败因素。为了找到该问题的解决方法,已经提出了多种解决方案。应该知道,大部分所使用的针具有0.4或0.5mm的直径。首先,需要增大针的直径以增加其刚性。推荐优选使用0.51mm的直径。传统地,针的内径为0.25mm。推荐使用双旋转插入技术(BRIT),其包括通过在刺入期间在一个方向上的半圈以及在另一方向的半圈交替旋转针,这消除了偏离的效果。这种操作执行起来非常困难,并且只有自动注射器才允许这么做。Troncular anesthesia is an anesthetic technique for the lower dental nerve before entering the dental channel. During the insertion of the needle into the soft tissue, especially during troncular anesthesia or local anesthesia, the needle is pushed very deep. During its insertion, the traditional needle deforms, which then leads to a curved trajectory, which makes it impossible to correctly perform the injection at the expected position. This is a factor of failure that cannot be ignored. In order to find a solution to this problem, a variety of solutions have been proposed. It should be known that most of the needles used have a diameter of 0.4 or 0.5 mm. First, it is necessary to increase the diameter of the needle to increase its rigidity. It is recommended to preferably use a diameter of 0.51 mm. Traditionally, the inner diameter of the needle is 0.25 mm. It is recommended to use the double rotation insertion technique (BRIT), which includes rotating the needle alternately half a circle in one direction and half a circle in the other direction during the insertion, which eliminates the effect of deviation. This operation is very difficult to perform, and only automatic injectors allow this.
发明内容Summary of the Invention
本发明的目的在于提出一种用以施加药品的注射针,其找到了克服上述缺点的解决方案。The object of the present invention is to propose an injection needle for administering a medicinal product, which finds a solution to overcome the above-mentioned drawbacks.
利用用于将药品注射到人体或动物体中的注射针来实现本发明的目的,其中,该针包括:管状体,具有两个相对端部,第一端部用于连接至产品供应装置,而第二端部用于刺入人体或动物体,第二端部设置有形成针尖的主斜面和次斜面。The objects of the present invention are achieved with an injection needle for injecting a medicinal product into the human or animal body, wherein the needle comprises a tubular body having two opposite ends, a first end for connection to a product supply device and a second end for piercing the human or animal body, the second end being provided with a primary bevel and a secondary bevel forming a needle tip.
根据本发明,次斜面被定位为与主斜面相对,并且与主斜面一起形成相对于管状体的纵轴倾斜的单个切割边缘,切割边缘在穿过管状体的纵轴的主斜面的中间面的任意一侧延伸。According to the invention, the secondary bevel is located opposite the primary bevel and together with the primary bevel forms a single cutting edge inclined relative to the longitudinal axis of the tubular body, the cutting edges extending on either side of a median face of the primary bevel passing through the longitudinal axis of the tubular body.
通过次斜面相对于主斜面的相对定位以及切割边缘在穿过管状体的纵轴的主斜面的中间面的任意一侧延伸,在针刺入身体的方向上看,形成针的前端以使针经受相互减小的近似反向力。从而,将针的偏离减小到最小。Due to the relative positioning of the secondary bevel with respect to the primary bevel and the fact that the cutting edge extends on either side of the median plane of the primary bevel passing through the longitudinal axis of the tubular body, the leading end of the needle, viewed in the direction of needle penetration into the body, is formed so that the needle is subjected to mutually reducing, approximately opposing forces. Thus, needle deflection is minimized.
根据本发明的该注射针的有益效果还可以进一步通过使针具有以下分别考虑或根据任意技术上可行的组合的特征中的至少一个来提高:The advantageous effects of the injection needle according to the present invention can be further enhanced by providing the needle with at least one of the following features, considered individually or in any technically feasible combination:
次斜面与管状体的纵轴一起形成小于10度的角;The secondary bevel forms an angle of less than 10 degrees with the longitudinal axis of the tubular body;
主斜面与管状体的纵轴一起形成5度至25度之间的角;The main bevel forms an angle of between 5 and 25 degrees with the longitudinal axis of the tubular body;
主斜面与管状体的纵轴一起形成5度至10度之间的角;The main bevel forms an angle of between 5 and 10 degrees with the longitudinal axis of the tubular body;
主斜面和次斜面在它们之间形成15度至30度之间的角;The primary bevel and the secondary bevel form an angle between them of between 15 degrees and 30 degrees;
对于不同的针口径,管状体具有小于标准值的内径;For different needle calibers, the tubular body has an inner diameter smaller than the standard value;
针设置有定位标记,相对于针的纵轴,该定位标记被定位为与主斜面相对。The needle is provided with a positioning mark which is positioned opposite the main bevel relative to the longitudinal axis of the needle.
附图说明BRIEF DESCRIPTION OF THE DRAWINGS
根据以下两个示例性实施例构成的针的描述,本发明的其他特征和优点将变得显而易见。参照附图进行描述,其中:Other features and advantages of the present invention will become apparent from the following description of a needle consisting of two exemplary embodiments, which are described with reference to the accompanying drawings, in which:
图1示出了在观看次斜面的侧视图中的根据本发明的第一注射针;FIG1 shows a first injection needle according to the present invention in a side view viewing a secondary bevel;
图2示出了在观看主斜面的侧视图中的第一针;FIG2 shows the first needle in a side view looking at the main bevel;
图3示出了观看主斜面的顶视图中的第一针;FIG3 shows the first needle in a top view looking at the main bevel;
图4示出了在两个斜面上的轴视图中的第一针;FIG4 shows the first needle in an axial view on two bevels;
图5示出了在观看次斜面的侧视图中的根据本发明的第二注射针;FIG5 shows a second injection needle according to the present invention in a side view viewing the secondary bevel;
图6示出了在观看主斜面的侧视图中的第二针;Figure 6 shows the second needle in a side view looking at the main bevel;
图7示出了主斜面上的顶视图中的第二针;FIG7 shows the second needle in a top view on the main bevel;
图8示出了在两个斜面上的轴视图中的第二针;以及Figure 8 shows the second needle in an axial view on two bevels; and
图9示出了具有定位标记的注射针。FIG. 9 shows an injection needle with positioning marks.
具体实施方式DETAILED DESCRIPTION
图1至图4示出了用于韧带内麻醉的注射针。该针包括具有纵轴A和两个相对端部2的管状体1,其第一端部2适用于连接至产品供应装置,例如连接至注射器或柔性管(该柔性管自身又连接至圆筒或任意其他类型的容器),或者连接至适用于以可编程的方式施加药品的自动装置。Figures 1 to 4 show an injection needle for intraligamentary anesthesia. The needle comprises a tubular body 1 having a longitudinal axis A and two opposite ends 2, a first end 2 of which is suitable for connection to a product supply device, such as a syringe or a flexible tube (which is itself connected to a cylinder or any other type of container), or to an automatic device suitable for administering a drug in a programmable manner.
用于刺入人体或动物体的第二端部3设置有主斜面4和次斜面5,二者形成单个切割边缘6和针尖7。The second end portion 3 for piercing a human or animal body is provided with a primary bevel 4 and a secondary bevel 5 , which together form a single cutting edge 6 and a needle tip 7 .
注射针的管状体1是基本中空的柱体,并且相对应纵轴A轴对称。因此,管状体1具有外径E1和内径L1。当外径E1表示注射针的口径时,内径L1表示管状体1的管腔大小,药品能够在注射期间穿过该管腔。The tubular body 1 of the injection needle is a substantially hollow cylinder and is symmetrical about the longitudinal axis A. Therefore, the tubular body 1 has an outer diameter E1 and an inner diameter L1. While the outer diameter E1 represents the caliber of the injection needle, the inner diameter L1 represents the size of the lumen of the tubular body 1 through which the drug can pass during injection.
在牙科手术中用于韧带内麻醉的注射针由具有0.3mm外径的管制成。根据本发明,在用于刺入人体或动物体的端部设置这种管,其具有相对定位的主斜面4和次斜面5,并在两个斜面之间具有相对小的角度D。以这种方式,斜面4和5之间的相交产生相对于针的管状体1的纵轴A的倾斜切割边缘6。切割边缘6的定向基本依赖于两个斜面之间的彼此相对定向。随着斜面之间角度D的逐渐增加,这种相对于管状体1的轴A的定向越来越远离相对于轴A的垂直配置。Injection needles used for intraligamentary anesthesia in dental surgery are made of tubing with an outer diameter of 0.3 mm. According to the present invention, this tubing is provided at the end intended for puncturing the human or animal body. It has a primary bevel 4 and a secondary bevel 5 positioned opposite each other, with a relatively small angle D between the two bevels. In this way, the intersection of bevels 4 and 5 creates an inclined cutting edge 6 relative to the longitudinal axis A of the needle's tubular body 1. The orientation of the cutting edge 6 depends primarily on the relative orientation of the two bevels. As the angle D between the bevels increases, this orientation relative to the axis A of the tubular body 1 deviates further and further from a perpendicular configuration.
然而,切割边缘6的定向也依赖于两个斜面中的每一个与管状体1的纵轴A一起形成的角度。在用于韧带内麻醉的注射针的情况下,主斜面4与纵轴A之间的角度B以及次斜面5与纵轴A之间的角度C至少近似相等,并且考虑到技术制造限制尽可能小。通过使相对于纵轴A的角度B和C小于10°,制造出非常平坦的针,其可以深深地插入韧带。However, the orientation of cutting edge 6 also depends on the angle that each of the two bevels forms with the longitudinal axis A of tubular body 1. In the case of an injection needle for intraligamentary anesthesia, angle B between primary bevel 4 and longitudinal axis A, as well as angle C between secondary bevel 5 and longitudinal axis A, are at least approximately equal and as small as possible given the technical manufacturing constraints. By making angles B and C less than 10° relative to longitudinal axis A, a very flat needle is produced that can be deeply inserted into the ligament.
同时,两个斜面4和5中的每一个与纵轴A之间的小角度(尤其是次斜面5与纵轴A之间的小角度C)只能通过使用比根据ISO 9626标准的管的情况下更厚的壁的特殊管来实现,该标准例如设置以下值:At the same time, the small angles between each of the two bevels 4 and 5 and the longitudinal axis A (in particular the small angle C between the secondary bevel 5 and the longitudinal axis A) can only be achieved by using special tubes with thicker walls than in the case of tubes according to the ISO 9626 standard, which sets the following values, for example:
为了制造根据本发明的针,通过使用具有较厚壁的管(因为其相对于标准针具有减小的内径L1),即,通过减小针的管腔的直径,可以使次斜面5更接近于管状体1的纵轴A,这减小了针的端部3处管腔的长度。To manufacture a needle according to the present invention, the secondary bevel 5 can be brought closer to the longitudinal axis A of the tubular body 1 by using a tube with thicker walls (because it has a reduced inner diameter L1 relative to a standard needle), i.e., by reducing the diameter of the lumen of the needle, which reduces the length of the lumen at the end 3 of the needle.
以这种方式,例如,注射针可以得到以下特性:In this way, for example, an injection needle can be given the following properties:
此外,次斜面5和纵轴A之间的角度C可以相对于传统针而减小。将类似的想法应用于主斜面4的定向以及与纵轴A一起形成的角度B1的定向。在图1至图4所示的示例性实施例中,角度B1和C以相同的公差相等,并具有7°±1°的数值。Furthermore, the angle C between the secondary bevel 5 and the longitudinal axis A can be reduced relative to conventional needles. A similar concept applies to the orientation of the primary bevel 4 and the angle B1 formed with the longitudinal axis A. In the exemplary embodiment shown in Figures 1 to 4, the angles B1 and C are equal with the same tolerance and have a value of 7°±1°.
能够用于韧带内麻醉的根据本发明的注射针主要具有两个优点。首先,通过使针具有叶片状端部,可以使其更加深地刺入组织。因此,抑制了注射期间的泄露,并使针尽可能少地受到其在更加深入地刺入组织时遇到的阻力的横向分量。此外,通过使用较厚壁的针,经受治疗的人或动物可以受益于更加刚性的管这一优点,并因此,使得针较少会经受传统针的变形、明显弯曲和对于主要来源的偏离。The injection needle according to the present invention, which can be used for intraligamentary anesthesia, has two main advantages. First, the blade-shaped tip of the needle allows deeper penetration into the tissue. This reduces leakage during injection and minimizes the lateral component of the resistance encountered by the needle during deeper penetration. Furthermore, by using a thicker-walled needle, the person or animal being treated benefits from a more rigid tube, making the needle less susceptible to deformation, significant bending, and deflection from the primary source associated with conventional needles.
总的来说,根据本发明的针在下面两个不同方面相对于传统针做出了改进,每一个方面都为加大刺入路径的线性度而相互独立地做出贡献。同时,这些优点可相加起来并被扩大。In summary, the needle according to the present invention is improved over conventional needles in two different aspects, each of which contributes independently to increasing the linearity of the insertion path.
为了完全实现本发明所提供的优点,根据本发明的针有利地在容纳管状体的针的管座(base)8上设置有图9所示的定位标记M。该标记相对于主斜面4位于针的背面。这使得专业人员知道针的主斜面实际上与粘膜平行。In order to fully realize the advantages provided by the present invention, the needle according to the present invention is advantageously provided with a positioning mark M as shown in FIG9 on the needle base 8 that receives the tubular body. This mark is located on the back of the needle relative to the main bevel 4. This allows the practitioner to know that the main bevel of the needle is actually parallel to the mucosa.
当根据本发明的注射针被应用于Troncular麻醉(即,用于沉积药品并且麻醉剂药品显著接近神经干)时,传统上使用口径25的针(即,具有0.5mm的外径)。然而,为了使这些针受益于本发明的配置,它们由仅具有约0.20mm的内径的管制成。其结果是针具有比标准针的壁更厚的壁。针壁厚度的增加首先使得其刚性得到加强,因此,减小了其刺入组织时的弯曲。接下来,通过壁厚的增加,可以使次斜面更加接近管状体1的纵轴A而不会穿透管腔。When the injection needle according to the present invention is applied to troncular anesthesia (i.e., for depositing drugs and the anesthetic drug is significantly close to the nerve trunk), a 25 caliber needle (i.e., with an outer diameter of 0.5 mm) is conventionally used. However, in order for these needles to benefit from the configuration of the present invention, they are made of a tube with an inner diameter of only about 0.20 mm. As a result, the needle has a thicker wall than that of a standard needle. The increase in the needle wall thickness first strengthens its rigidity and, therefore, reduces its bending when piercing the tissue. Next, by increasing the wall thickness, the secondary bevel can be brought closer to the longitudinal axis A of the tubular body 1 without penetrating the lumen.
因此,对于图5至图8所示的根据第二示例性实施例所制造的注射针,再次发现其基本配置与参照第一示例性实施例描述的相同。Thus, for the injection needle manufactured according to the second exemplary embodiment shown in Figures 5 to 8, its basic configuration is again found to be the same as described with reference to the first exemplary embodiment.
然而,由于与第一示例性实施例的针的口径E1相比,根据第二示例性实施例的针具有较大口径E2,以及由于内径L2相应地且较少程度上地大于第一示例性实施例的针的内径L1,所以根据第二示例性实施例的针的主斜面41不能够与根据第一示例性实施例的主斜面的角度一样小。因此,主斜面41与纵轴A一起形成的角度B2为约20°至25°,例如为21°±1°。However, since the needle according to the second exemplary embodiment has a larger caliber E2 than the caliber E1 of the needle of the first exemplary embodiment, and since the inner diameter L2 is correspondingly and to a lesser extent larger than the inner diameter L1 of the needle of the first exemplary embodiment, the main bevel 41 of the needle according to the second exemplary embodiment cannot have the same small angle as the main bevel according to the first exemplary embodiment. Therefore, the angle B2 formed by the main bevel 41 together with the longitudinal axis A is approximately 20° to 25°, for example, 21°±1°.
与此不同,次斜面51与导管1的纵轴A一起形成的角度C与根据第一示例性实施例的针的角度C相同,即,小于10°,优选为7°±1°。因此,对于根据第一示例性实施例的次斜面5和根据第二示例性实施例的次斜面51,可以实现与纵轴A一起形成的角度C达到6°。In contrast, the angle C formed by the secondary bevel 51 together with the longitudinal axis A of the catheter 1 is the same as the angle C of the needle according to the first exemplary embodiment, i.e., less than 10°, preferably 7°±1°. Thus, for the secondary bevel 5 according to the first exemplary embodiment and the secondary bevel 51 according to the second exemplary embodiment, an angle C formed together with the longitudinal axis A of up to 6° can be achieved.
尽管根据第二示例性实施例的针的主斜面和次斜面不具有与根据第一示例性实施例一样的小角度,但针的端部仍然经受几乎相等的反向力,明显具有较小的横向分量,这显著减小了针在刺入人体或动物体的组织时的偏离风险。Although the primary and secondary bevels of the needle according to the second exemplary embodiment do not have the same small angles as according to the first exemplary embodiment, the end of the needle is still subjected to almost equal opposing forces, with a significantly smaller lateral component, which significantly reduces the risk of deviation of the needle when penetrating tissue of the human or animal body.
Claims (5)
Applications Claiming Priority (1)
| Application Number | Priority Date | Filing Date | Title |
|---|---|---|---|
| FR0857306 | 2008-10-28 |
Publications (2)
| Publication Number | Publication Date |
|---|---|
| HK1237291A1 HK1237291A1 (en) | 2018-04-13 |
| HK1237291B true HK1237291B (en) | 2021-02-11 |
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