CN102209568A - Medical tool for reduced penetration force with feedback means - Google Patents

Medical tool for reduced penetration force with feedback means Download PDF

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CN102209568A
CN102209568A CN 200980144604 CN200980144604A CN102209568A CN 102209568 A CN102209568 A CN 102209568A CN 200980144604 CN200980144604 CN 200980144604 CN 200980144604 A CN200980144604 A CN 200980144604A CN 102209568 A CN102209568 A CN 102209568A
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member
penetrating
tissue
medical
passage
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CN 200980144604
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Chinese (zh)
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保罗·L·弗阮克豪斯
布赖恩·M·帕克
莫林·L·马尔维希尔
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压电共振创新股份有限公司
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/025Pointed or sharp biopsy instruments for taking bone, bone marrow or cartilage samples
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0283Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/32Surgical cutting instruments
    • A61B17/320068Surgical cutting instruments using mechanical vibrations, e.g. ultrasonic
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3401Puncturing needles for the peridural or subarachnoid space or the plexus, e.g. for anaesthesia
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B2010/0003Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements including means for analysis by an unskilled person
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B18/00Surgical instruments, devices or methods for transferring non-mechanical forms of energy to or from the body
    • A61B2018/00053Mechanical features of the instrument of device
    • A61B2018/00184Moving parts
    • A61B2018/00196Moving parts reciprocating lengthwise

Abstract

A medical device for reducing the force necessary to penetrate living being tissue using a variety of reciprocating motion actuators, including piezoelectric, voice coil, solenoids, pneumatics or fluidics. The reciprocating actuator drives a penetrating member, such as a needle, through the tissue at a reduced force while the device detects the passage of the penetrating member through the tissue. Upon passage of the penetrating member through the tissue, electrical power to the reciprocating actuator is automatically terminated. One exemplary method for detecting this passage is via a fluid-containing syringe that is coupled to a channel within the penetrating member.; Once the penetrating member tip has passed through the living tissue, the fluid within the syringe no longer experiences any pressure and a plunger within the syringe displaces indicating passage of the penetrating member tip. This motion can provide direct tactile feedback to an operator of the medical device or can automatically open a switch providing electrical power to the medical device. Alternatively, a pressure transducer can also monitor the pressure within the penetrating member channel and automatically activate the switch to cut off the electrical power.

Description

具有反馈装置的减小穿透力用医疗工具 Feedback means having a reduced penetration force with a medical instrument

[0001] 相关申请的交叉引用 CROSS [0001] REFERENCE TO RELATED APPLICATIONS

[0002] 本PCT申请要求2008年9月15日申请、标题为“具有反馈装置的减小穿透力用医疗工具”的临时申请号为61/089,756的在35U. SC § 119(e)下的权益,上述申请的全部公开内容以引用的方式并入本文。 [0002] This PCT application claims filed September 15, 2008, Provisional Application No. entitled "reduced penetration force feedback device having a medical instrument" 61 / 089,756 in 35U. SC § 119 (e ) benefit under, the entire disclosure of the above application is incorporated by reference herein.

技术领域 FIELD

[0003] 本发明通常涉及手持式医疗器械,更具体地涉及电驱动柳叶刀、硬膜外导管插件、 活检医疗仪器(例如骨活检医疗器械)、进血管穿透件、脊椎穿刺针和其他导管插入针。 [0003] The present invention relates generally to handheld medical devices, and more particularly to electrically driven lancet, plug epidural catheter, biopsy medical instrument (e.g., bone biopsy medical instrument), the penetrating member into the blood vessels, and other spinal needle a catheter insertion needle. 本发明适用于输送和清除体内的血液、组织、药物、骨髓、营养物质或其他物质。 The present invention is applicable to the delivery and removal of blood, tissue, drugs, bone marrow, nutrients or other substances in the body.

背景技术 Background technique

[0004] 硬膜外麻醉是局部麻醉的一种形式,涉及将药物直接注射在硬膜外腔内。 [0004] Epidural anesthesia is a form of regional anesthesia involving injection of drugs directly to the epidural space. 当开始所述手术时,使针从皮肤外层插入,穿过多层组织,最后置入硬膜外腔,导管选择性地穿过硬膜外腔。 When starting the operation, the needle is inserted from the outer layer of skin, through the multi-layer weave, and finally placed in epidural catheter through the epidural space selectively. 将局部麻醉药注入硬膜外腔,通过抑制疼痛信号通过脊髓内和周围的神经暂时失去知觉和痛觉。 The local anesthetic injected into the epidural space, by inhibiting pain signal to the spinal cord and peripheral nerve pain and temporary loss of consciousness. 由于较钝的硬膜外针穿透棘上韧带、棘间韧带和黄韧带时需要高水平力, 手术可使患者感到不适。 Due to blunt the epidural needle penetrates the spine ligament requires a high level of force interspinous ligament and yellow ligament, surgery can make patients feel uncomfortable. 一种并发症是,由于所述高穿透力和阻挡所述针穿入硬膜外腔时几乎是瞬时变化的(即瞬时最大程度减小力后的较高向前动力),临床医师会意外过冲和刺穿硬脑膜。 Is a complication, because of the high penetration barrier and is almost (i.e., high forward momentum after the instantaneous minimizes the force) when the instantaneous change in the needle penetration epidural space, the clinician will unexpected overshoot and puncture the dura. 刺穿硬脑膜后,脑脊液可渗入硬膜外腔,使患者出现严重的硬膜穿刺后头痛, 可持续数天,甚至几年。 After piercing dura, cerebrospinal fluid can penetrate into the epidural space, the patient severe headache after dural puncture, can last for days, or even years. 大量渗漏可产生足以使静脉破裂的颅内低压,造成硬脑膜下血肿和牵引性脑神经损伤,导致耳鸣、听力损失、头晕、脸下垂或复视。 Leakage can produce enough to make a lot of intracranial hypotension veins rupture, resulting in hematoma and subdural traction brain damage, resulting in tinnitus, hearing loss, dizziness, double vision or drooping face.

[0005] 骨髓活检用于诊断肿瘤和各种骨病。 [0005] Bone marrow biopsy for diagnosis of cancer and a variety of bone diseases. 最常用的骨活检部位是前髂嵴。 The most common bone biopsy site is the anterior iliac crest. 主要缺点是穿透骨组织所需的力和通常用于使针向内的扭转运动使患者感到不适且由受损组织引起可能性愈合并发症。 The main disadvantage is the force required to penetrate the bone and a generally torsional movement of the needle for inward patient discomfort and tissue damage caused by the possibility of healing complications. 穿透力也可能使临床医师感到劳累,并导致多次抽样尝试。 Penetration clinicians may also feel tired and cause multiple sampling attempts. 并发症很少见,但可包括出血、疼痛和感染。 Complications are rare, but can include bleeding, pain and infection. 尽管在某些手术的插入和收回中,患者仍然会产生压觉, 采用适当的局部麻醉能最大程度减少疼痛。 Although the insertion and retraction of some surgery, the patient will still generate pressure sensation, with appropriate local anesthesia can minimize pain. 另一个问题是压碎样品或者是不能取回部分或全部样品,从而限制诊断能力。 Another problem is crushing the sample or not to retrieve some or all of the samples, thus limiting the diagnosis capability. 如图1所示,活检工具PAl通常包括把手(未显示)和空心套管1,空心套管1的套管远端1'围绕连接把手的管心针2。 As shown in FIG. 1, generally comprises a handle PAl biopsy tool (not shown) and a hollow sleeve, the hollow sleeve distal end of the sleeve 1 1 'connected to the handle around the stylet 2. 为了穿透皮质骨,临床医师使套管和管心针穿过骨到达骨髓。 In order to penetrate cortical bone, a clinician and the sleeve reaches the stylet through the bone marrow. 内管心针或套管针的远端尖3尖锐,且具有凿子似的角面4,角面4通过减少表面积减少施力。 Inner stylet distal tip 3 of the needle cannula or sharp corners and having a chisel-like face 4, 4 angular urging reduced by reducing the surface area.

[0006] 目前,为了最大程度减小硬脑膜穿刺的可能性,通常使用专门设计的16-18规格较钝的针PA2 (例如图2所示的称为Tuohy针5的针)非常缓慢地进行硬膜外导管插入过程。 [0006] Currently, to minimize the possibility of dural puncture, typically using specially designed specifications 16-18 blunt needle PA2 (e.g. FIG. 2 is referred to as the Tuohy needle 5) performed very slowly epidural catheter insertion process. 硬膜外针,例如Tuohy针5或Hustead针,具有减少针“尖锐度”的定向弯曲尖6,因此使意外硬脑膜穿刺更困难。 Epidural needle, e.g. Tuohy needle 5 or Hustead needle, has a directional curved tip to reduce needle "sharpness" of 6, thus accidental dura puncture more difficult. 弯曲尖也便于将留置导管导入硬膜外腔,尖开口7便于导管或流体导入或去除。 The curved tip also facilitates indwelling catheter into the epidural space, the tip opening 7 facilitates catheter or fluid introduction or removal. 遗憾的是,所述钝弯曲尖设计实际上增大了临床医师必须使用的力,使临床医师更难在穿透硬脑膜腔后停止向前动力。 Unfortunately, the blunt curved tip design actually increases the force a clinician must use and makes it more difficult clinician stops forward momentum after penetrating the dura chamber. 此外,Tuohy设计增加了临床医师在穿透过程中依靠触觉反馈的可能性。 In addition, Tuohy design increases the likelihood of clinicians rely on tactile feedback during penetration. 换句话说,临床医师在插入手术中会依靠于感觉“挤破感”(表明针穿过黄韧带)确定针的尖在硬膜外腔内的位置,并快速停止施加的向前动力。 In other words, in the insertion procedure a clinician will rely on feeling "squeeze sense broken" (indicating needle through the ligamentum flavum) determining the position of the tip of the needle within the epidural space and quickly stop the forward momentum applied. 尽管如此,由于穿透其他组织(例如肌肉、钙化韧带或一般韧带)可能产生类似的挤破感,临床医师可能不会完全感觉针尖的正确位置(针尖穿过上述组织前被堵塞)。 Nevertheless, due to the penetration of other tissues (such as muscle, ligament, calcified ligaments or general) may have a similar sense of racking, the clinician may not fully feel the correct position of the needle tip (tip through the clogged before the above organizations).

[0007] 已开发出若干替代技术,试图最大程度降低硬脑膜穿刺风险,同时向临床医师给出成功硬膜外放置的指示。 [0007] Several alternative technologies have been developed to try to reduce the risk of dural puncture greatest extent, while giving an indication of successful epidural placement of the clinician. 例如,美国专利申请公布号为2007/0142766的说明书中(Simdar等人)公开的检测方法和设备(其内容以引用的方式并入本文)在成功进入后依靠弹簧柱塞将流体推入硬膜外腔。 For example, U.S. Patent Application Publication No. 2007/0142766 in the specification (Simdar et al.) Discloses a method and apparatus for detecting (embodiment the contents are incorporated herein by reference) means of a spring pushing the plunger of the fluid entering the dura mater after successful external cavity. 相应地,临床医师收到视觉指示器(即流体在针开口处无阻力时的柱塞移动),然后停止施加向前推力。 Accordingly, the clinician receives visual indicator (i.e., fluid movement of the plunger when the needle opening without resistance), and then stops applying the forward thrust. 同样地,美国专利号为5, 681, 283 (Brownfield)中也依靠视觉指示器向临床医师传达针成功进入腔体的信息。 Similarly, US Patent No. 5, 681, 283 (Brownfield) also rely on visual indicator needle to convey information to the clinician successful entry into the cavity. 遗憾的是,尽管视觉指示器是正向前进,但并未启示或提出意外硬脑膜壁穿刺的实际原因,即临床医师对针施加的穿过各种组织层然后停止针的较高力。 Unfortunately, despite the visual indicator is positive going, but did not propose the actual cause of the accident or revelation dural puncture wall, that clinicians and high force applied through the various layers of tissue needle stop needle.

[0008] 因此,存在减小针穿刺力并使临床医师能更好控制进入硬膜外腔的工具用针,例如Tuohy针,从而减少意外硬脑膜穿刺的可能性。 [0008] Accordingly, there is reduced needle penetration force and clinician better control of the tool with a needle into the epidural space, e.g. Tuohy needle, thereby reducing the likelihood of accidental dura puncture.

[0009] 尽管意外硬脑膜穿刺是一个关注问题,仅定位硬膜外腔甚至可能对最熟练的医师提出挑战。 [0009] Although dural puncture accidents is a concern to target only the epidural space may even challenge the most skilled physician. 因此,针(例如Tuohy针)穿过黄韧带进入硬膜外腔时,接收指示针尖成功穿透及其位置的即时反馈有利于临床医师。 Thus, when the needle (e.g., Tuohy needle) into the epidural space through the ligamentum flavum, and receive an indication of immediate feedback successfully penetrate the tip position facilitates clinician. 基本的传统反馈装置(例如图加所示的反馈装置) 包括连接注射器PA3前部9的针(未显示),其中注射器PA3由管状体10形成,并容纳包括用作偏置元件的杆的偏置元件11。 Partial basic conventional feedback device (e.g., feedback means shown in FIG plus) comprises a needle connected to a syringe PA3 front portion 9 (not shown), wherein the syringe PA3 is formed of a tubular body 10, and includes a rod receiving element is used as the biasing element 11 is set. 为了提供指示成功硬膜外穿透的反馈,反馈装置依靠作用于偏置元件11的偏置力,然后偏置元件11作用于注射器内的流体,例如盐水或空气。 To provide feedback indicating successful epidural penetration the feedback device relies on a biasing force acting on the biasing element 11 biasing element 11 then acts on the fluid within the syringe, such as saline or air. 在该液压反馈方法中,由于偏置力作用于流体,流体基本上将该压力转到针尖的开口。 In this hydraulic feedback method, since the biasing force acts on the fluid, the fluid pressure to substantially the tip opening. 由于针尖靠在组织(例如黄韧带)上而作用于针尖的反作用力用于防止从该注射器释放该流体。 Since the needle tip against the tissue (e.g., yellow ligament) a reaction force acting on the needle for preventing the release of fluid from the syringe. 临床医师的拇指通常作为偏置力源,该偏置力源反过来作用于柱塞杆。 Typically the clinician's thumb as a bias power source, the biasing force applied to the plunger rod in turn source. 临床医师的拇指用于“感觉”组织的反作用力施加在流体上的液压阻力。 A reaction force for the clinician's thumb "feel" of the tissue applied to the fluid in the hydraulic resistance. 然而,进入硬膜外腔后,消除了作用于针尖的组织的反作用压力,压力下降使偏置力通过针尖将溶液移出该注射器。 However, after entering the epidural space, eliminates tissue reaction pressure acting on the tip, the biasing force of the pressure drop through the syringe needle out of the solution. 由于其拇指“感觉”柱塞杆处压力骤降或无阻力,临床医师则意识到成功穿透硬膜外腔。 Because of its thumb "feel" of the plunger rod at the sudden pressure drop, or no resistance, the clinician appreciated successfully penetrate the epidural space. 另外,将流体释放到患者的硬膜外腔内时,临床医师可通过见证柱塞从外部进入注射器收到成功穿透的视觉指示。 Further, when the fluid is released into the epidural space of the patient, the clinician may receive from the outside into the syringe through the visual indication of successful penetration of the plunger witness. 该传统装置和方法的一个问题是,临床医师很难在施加相对注射器本体的前进力(使针进入黄韧带)的同时向柱塞施加偏置力。 One problem with this conventional device and method is that the clinician is difficult to exert a force opposing advancement of the syringe body (the needle into the ligamentum flavum) while Saishi Jia biasing force to the column. 此外,为了防止意外硬脑膜穿刺,施加作用于注射器的向前动力和作用于柱塞杆的偏置力时,临床医师倾向于以使患者保持稳定的方式握住传统注射器,从而使临床医师和患者均感到棘手和不适。 In order to prevent accidental dura puncture, and power is applied to the forward acting acting on the bias force of the syringe plunger rod, clinicians tend to maintain the patient to hold the conventional syringe in a stable manner, so that the clinician and patients feel difficult and uncomfortable.

[0010] 一些改进也试图提供对硬膜外注射器的柱塞起作用的自动偏置元件,同时也提供成功穿刺人体内各内靶区的视觉指示或反馈,而非触觉反应。 [0010] Some improvements have also attempted to provide an automatic biasing element acting on the plunger of an epidural syringe while also providing visual indication or feedback of each target within the body piercing success, rather than tactile response. 例如,在美国公布号为2007/0142766 (Simdar等人)中,弹簧用于连同偏置力作用于注射器柱塞。 For example, in U.S. Publication No. 2007/0142766 (Simdar et al.), Together with the spring biasing force is applied to the syringe plunger. 连接该注射器的硬膜外针穿入硬脑膜腔时,压力下降使弹簧偏置柱塞。 When connecting the syringe needle penetrates the dura epidural cavity, the pressure drop of the spring biased plunger. 柱塞移动时,由于柱塞杆与柱塞一起移动,所以柱塞杆至少提供一些视觉指示。 When the movement of the plunger, because the plunger rod moves together with the plunger, so that at least some of the plunger rod to provide a visual indication. 同样地,美国专利号为5,024,662 (Menes等人) (该专利以引用的方式并入本文)中通过使用弹性带提供作用于柱塞杆的偏置力而提供视觉指示。 Similarly, U.S. Patent No. biasing force of the plunger rod and provide a visual indication provided by the use of elastic bands act as 5,024,662 (Menes et al) (which patent is incorporated by reference herein). 在美国专利号为4,623,335 (Jackson)(该专利以引用的方式并入本文)中,替代装置协助从视觉上指示压力,以确定针尖的位置。 In U.S. Patent No. 4,623,335 (Jackson) (which patent is incorporated by reference herein), instead of the pressure indicating device to assist visually to determine the position of the needle tip. 此外,美国专利号为7,四7,131 (Call)(该专利以引用的方式并入本文)中使用压力传感器将压力变化转化为电子信号。 Further, U.S. Patent No. 7, four 7,131 (Call) (which patent is incorporated by reference herein) using a pressure sensor to pressure changes into electrical signals. 然后,例如通过激活发光二极管发光将电子信号转换至视觉显示指示器。 Then, for example by activating a light emitting diode to convert electrical signals to a visual display indicator.

[0011] 因此,需要克服惯常采用的技术未解决的挑战,以减小医疗器械的尖锐医疗元件穿过组织所需的力,还能从皮下(例如骨活检等)输入(例如输入盐溶液或药物等)或取回物质。 [0011] Thus, the technical challenges to overcome unresolved conventionally employed to reduce sharp medical element of the medical device through the force desired tissue, for example, can enter the saline solution subcutaneously (e.g., bone biopsy, etc.) input (or drugs, etc.) or retrieve materials.

[0012] 尤其是进入该空间的力显著减小时,还需要向临床医师提供穿透件已成功穿透具体人体空间(例如硬膜外腔)的视觉指示、触觉指示、电气指示或其他指示。 [0012] In particular, when a force into the space is significantly reduced, also the need to provide penetrating member has successfully penetrated the specific body space (e.g. epidural space) is a visual indication to the clinician, a tactile indication, an electrical indication or other indication. 进入硬膜外腔后,必须立即控制或停止相同减力,以避免(更容易)穿透硬脑膜。 After entering the epidural space, it must be the same as the control force reduction or stop immediately to avoid (easier) penetration of the dura.

[0013] 具体地,医疗器械领域需要具有穿透件的改进医疗器械,该穿透件以一定频率振动,从而减小穿透组织所需的力;减少造成的组织损伤和疤痕量,提高进入人体空间或脉管的成功率;最大程度减少引入伤口部位创伤,最重要的是提高患者的舒适度,同时最大程度减少可能的并发症。 [0013] In particular, the need for medical devices having an improved medical instrument penetrating member, the penetrating member at a constant frequency of vibration, thereby reducing the force required to penetrate tissue; reduced the amount of scar tissue caused by injury and improve into the body space or vessel success rate; minimize the introduction of the wound site trauma, most importantly, improve patient comfort, while minimizing possible complications.

[0014] 在骨活检过程中,需要临床医师能用较小力穿透硬组织(例如骨皮质),从而减轻临床医师的疲劳、患者的不适和组织损伤,同时提高抽样成功率和质量。 [0014] In the process of bone biopsy, the clinician can require less force to penetrate hard tissue (e.g., cortical bone), thereby reducing fatigue, patient discomfort and tissue damage clinicians, while improving the sampling success rate and quality. 需要检测适合的位置,停止向前运动和收集样品。 Need to detect a suitable position to stop forward movement and collect samples. 由于从身体收回穿透件,所以收集样品后,还需要打开器械, 并减小力和减轻患者的不适感。 Since the penetrating member withdrawn from the body, so after collecting samples, also need to open the equipment, and reduce the force and alleviate patient discomfort.

[0015] 还需要脊椎入路手术,由于临床医师不想到达组织核心,进行脊椎入路手术时,临床医师想要减小力量并知道针尖的位置但会将力施加于相对尖锐的穿透件,例如笔尖。 [0015] also need to approach the spine surgery, as clinicians do not want to reach the core of the organization, carried out during spinal surgery approach, clinicians want to reduce the strength and know the location of the needle tip but will force applied to the relatively sharp penetrating member, For example nib.

[0016] 还需要进行神经阻滞术,进行神经阻滞术时,临床医师想要减小力量并知道针尖的位置。 When the [0016] need to be nerve block technique, nerve block technique, the clinician wants to reduce the strength and know the location of the needle tip. 进入所需位置后,必须立即控制或停止相同减力。 After entering the desired position, the control must be the same force reduction or stop immediately.

[0017] 本文引用的所有参考的全部内容均以引用的方式并入本文。 [0017] All references cited herein are incorporated by reference herein.

发明内容 SUMMARY

[0018] 本发明的基础是一种远端具有穿透件(例如引导针、Tuohy针、铅笔尖针、套管针(例如JAMSHIDI®活检针)等)且用于手术(例如血管注射和导管插入、单次注射或连续硬膜外麻醉、脊椎进入、局部阻滞或骨活检等)的手持式医疗器械(例如硬膜外针、骨活检器械、脊椎穿刺针、局部阻滞针、导管引导针等),其中所述医疗器械包括连接所述穿透件(例如位于穿透件远端)的至少一个驱动致动器(例如压电体、音圈、螺线管、气动致动器、 流体致动器或任何振荡致动器或平移致动器等),其中所述驱动致动器平移所述穿透件,使其往复运动,产生较小位移,从而减小穿透组织所需的力。 [0018] The basis of the present invention is a distal end having a penetrating member (e.g., introducer needle, a Tuohy needle, pencil sharp needle, a trocar (e.g. JAMSHIDI® biopsy needle), etc.) and used in surgery (e.g., intravascular injection, and catheter insert, a single injection or continuous epidural anesthesia, into the spine, a bone biopsy, or a partial block) handheld medical device (e.g., epidural needle, bone biopsy device, spinal needle, partially block needle, catheter guidance needles, etc.), wherein the medical device comprises a connector member penetrating (e.g., penetrating member distal end is located) of the at least one drive actuator (e.g. piezoelectric, voice coil, solenoid, a pneumatic actuator, a fluid actuator or any oscillatory or translational actuator actuator, etc.), wherein said driving actuator translating the penetrating member so as to reciprocate, generating small displacements, thereby reducing the desired tissue penetration of force.

[0019] 此外,本发明包括通过各种检测机构(例如但不限于电气装置、磁性装置、压力装置、电容装置、感应装置等)提供视觉、听觉或触觉反应反馈的装置,以指示成功穿透各种组织或身体内空隙,例如硬膜外腔,使得临床医师知道何时关闭和限制所述驱动机构的电源。 [0019] Further, the present invention includes a variety of detection means (e.g., but not limited to electrical, magnetic means, pressure means, capacitive means, sensing means, etc.) to provide a visual means, auditory feedback, or tactile response, to indicate successful penetration voids within various tissues or body, for example the epidural cavity, so that the clinician knows when to close and power limitations of the drive mechanism.

[0020] 压电材料自身的最大应变限度阻碍依靠传统、单一或堆叠压电材料组件致动的致动器技术。 [0020] their maximum strain limit of the piezoelectric actuator material hinder techniques rely on conventional, single or stacked piezoelectric material of the actuator assembly. 由于传统压电材料的最大应变限度约为多晶压电材料(例如锆钛酸铅(PZT)多晶(也称为陶瓷)材料)的0.1%,单晶压电材料的0.5%,需要一大堆电池实现(例如可用于组织穿透手术的手持式医疗器械的)有用位移或致动。 Because the maximum strain limit of conventional piezoelectric materials is about polycrystalline piezoelectric material (e.g., lead zirconate titanate (PZT) polycrystalline (also referred to as ceramic) material) 0.1% 0.5% a single crystal piezoelectric material requires a displacement piles at useful battery (e.g., can be used to penetrate tissue handheld medical device of surgery) or actuation. 然而,使用一大堆电池启动手持件部件时,还需要使工具的尺寸超过手持式仪器的可用生物测定设计。 However, when starting to use a lot of battery handpiece member, also a need for tools usable biometric design size exceeds the hand-held unit.

[0021] 已开发出弯张致动器组件设计,该弯张致动器组件设计提供压电材料堆应变位移放大。 [0021] have developed a flextensional actuator assembly design, the flextensional actuator assembly designed to provide a piezoelectric actuator material stack strain displacement amplification. 该弯张设计包括置于框架、台板、端盖或外壳内的压电材料驱动电池。 The flextensional designs comprise a frame placed on the platen, the piezoelectric material in the cover or the housing of the drive battery. 所述框架、台板、端盖或外壳的几何形状提供驱动电池的轴向或纵向运动放大,以获得该弯张组件在特定方向的较大位移。 The frame, a platen, cover or housing geometry provides driving battery axial or longitudinal movement of amplification, to obtain a larger displacement of the flextensional assembly in a particular direction. 实际上,该弯张致动器组件更有效地将一个方向的应力转换为第二方向的运动(或力)。 In fact, the flextensional actuator assembly more efficiently converts the movement direction of a stress (or force) in the second direction. 弯张压电致动器可视为中频致动器,例如25_35kHz。 Flextensional piezoelectric actuators may be considered an intermediate frequency actuators, e.g. 25_35kHz. 弯张致动器可具有若干实施方式。 Flextensional actuator may have several embodiments. 例如,在一个实施例中,弯张致动器为美国专利号为5,729, 077 (Newnham) 中所述的钹型弯张致动器,该专利以引用的方式并入本文。 For example, in one embodiment, flextensional actuators U.S. Patent No. 5,729, 077 (Newnham) in said flextensional Cymbal actuator, which patent is incorporated by reference herein. 在另一个实施例中,弯张致动器为美国专利号为6,465,936(KnOWleS)中所述的放大型压电致动器(“APA”),该专利以引用的方式并入本文。 In another embodiment, flextensional actuators U.S. Patent No. 6,465,936 (KnOWleS) in the amplified piezoelectric actuator ( "APA"), which patent is incorporated by reference This article. 在又一个实施例中,致动器为类似但不限于美国专利申请公布号为2007/0063618A1中(Bromfield)公开的Langevin或栓接哑铃型致动器,该专利申请公开说明书以引用的方式并入本文。 In yet another embodiment, the actuator is similar to, but not limited to, U.S. Patent Application Publication No. in 2007 / 0063618A1 (Bromfield) disclosed Langevin or bolted dumbbell-type actuator, which Patent Application Publication reference and incorporated herein.

[0022] 在优选实施例中,本发明包括手持式器械,所述手持式器械包括本体、置于所述本体内的弯张致动器和连接所述弯张致动器一面的穿透件或“尖锐”件。 [0022] In a preferred embodiment, the present invention comprises a handheld device, the handheld device includes a body, said body disposed flextensional actuator and connecting the actuator side flextensional penetrating member or "sharp" pieces. 在本发明的广泛范围内,所述穿透件可为空心或实心穿透件。 Within the broad scope of the present invention, the penetrating member penetrating member may be hollow or solid. 所述致动器可具有贯穿远端和近端的内孔或位于穿透件连接附件上的侧孔。 The actuator may have a bore through the distal and proximal side aperture positioned on or connected to the penetrating member attachment. 因此,对一次性穿透件来说,使用后不需要对穿透件进行灭菌。 Thus, disposable penetrating member, the penetrating member after use does not need to be sterilized. 如果所述穿透件为空心穿透件,所述空心穿透件形成具有尖锐远端的空心管状结构。 If the penetrating member is a hollow penetrating member, penetrating the hollow member form a hollow tubular structure having a sharpened distal end. 所述穿透件的空心中心部分与所述致动器的所述内孔同心,共同形成所述致动器本体远端至所述穿透件近端的连续空腔。 Hollow central portion of the penetrating member is concentric with the inner bore of the actuator, together forming the distal end of the actuator body to the proximal end of the penetrating member continuous cavity. 例如,所述弯张致动器组件可利用弯张钹型致动器技术或放大型压电致动器ΑΡΑ)技术。 For example, the flextensional actuator assembly may utilize flextensional Cymbal actuator technology or amplified piezoelectric actuator ΑΡΑ) technology. 所述弯张致动器组件提供传统手持式器械以外的进一步放大和改进性能。 The flextensional actuator assembly provides a further enlarged than traditional handheld devices and improve performance. 例如,放大可提高约50倍。 For example, amplification may be increased by about 50 times. 此外,所述弯张致动器组件使手持件配置具有更简单的设计和较小规格。 Additionally, the flextensional actuator assembly arranged so that the handpiece has a simpler design and a smaller format.

[0023] 本发明的一个实施例是谐振驱动血管注射针,所述谐振驱动血管注射针用以减少所述穿透件的插入力和减少脉管系统卷起或衰竭。 [0023] An embodiment of the present invention is a resonance driven vascular injection needle, said needle resonant driving vessel to reduce insertion force of the penetrating member and to reduce rolling or failure vasculature.

[0024] 本发明的一个替代实施例是一种减力硬膜外针,所述减力硬膜外针使临床医师能更好控制进入硬膜外腔,从而最大程度减少硬脑膜鞘的意外穿刺。 An alternative [0024] embodiment of the present invention is a force reduction of the epidural needle, the epidural needle Save force allows the clinician to better control into the epidural space, thereby reducing the maximum degree of accidental dural sheath puncture. 在该实施例中,致动器(例如Langevin致动器(通常称为Langevin传感器))具有连接所述致动器远端部分的空心穿透件,例如空心针。 In this embodiment, the actuator (e.g., a Langevin actuator (commonly referred to as Langevin transducer)) connected to said actuator having a hollow penetrating member distal end portion of the actuator, such as a hollow needle. 在该实施例中,Langevin致动器的另一端可能打开。 In this embodiment, a Langevin actuator and the other end may be open. 开口包括从所述致动器远端连续延伸至所述致动器近端的空心部分。 Actuator comprising a distal opening extending continuously from said actuator to said actuation hollow portion of the proximal end of the actuator. 所述远端开口与所述空心穿透件一致。 The distal opening is consistent with the hollow penetrating member. 具有把手、轴和密封件的柱塞也连接所述尖锐件另一端的致动器。 Having a handle, the plunger seal and the shaft is also connected to the other end of the sharps actuator. 所述柱塞轴可滑动地置于所述致动器的连续空心内部。 The plunger shaft is slidably disposed inside said continuous hollow actuator. 所述密封件连接所述柱塞轴的远端部分,分离所述致动器空心内部的远端体积与所述空心内部的近端体积。 The distal portion of the sealing member is connected to the plunger shaft, separating the proximal actuation volume volume inside the actuator distal end of the hollow interior of the hollow. 由于所述柱塞轴可滑动布置,为了适应所述轴在远端方向的运动,所述柱塞也可滑动布置,并减少所述空心内部的远端体积, 增加所述近端体积。 Since the plunger shaft is slidably disposed, in order to accommodate movement of the shaft in a distal direction, the plunger may be slidably disposed, and reduce the volume of the hollow interior of the distal end, the proximal end of the volume increase. 相反地,为了适应所述轴在近端方向的运动,所述密封件还可沿近端方向移动,从而减少所述空心部分的近端体积,增加所述远端体积。 Conversely, to accommodate movement of the shaft in a proximal direction, the seal member may also be moved in the proximal direction, thereby reducing the volume of the hollow portion of the proximal end, the distal end of the volume increase. 作用在所述柱塞把手上的外力有效驱动所述柱塞轴和所述柱塞密封件的运动。 External force acting on the plunger handle effectively driving movement of said plunger shaft and the plunger seal. 若通过电气启动,所述致动器将所述压电材料部分的压缩和膨胀转移到所述空心针的空心穿透尖。 If the electrically actuated by the actuator to the compression and expansion of the piezoelectric material portion is transferred to said hollow needle to penetrate the hollow tip. Langevin致动器可视为高频率致动器,例如> 50kHz。 Langevin actuators may be considered high frequency actuators, e.g.> 50kHz.

[0025] 本发明的另一实施例提供一种骨髓活检器械,所述骨髓活检器械具有外壳和致动器,例如Langevin致动器(例如参见美国专利号为6,491,708的专利(Madan等人),其全部公开内容均以引用的方式并入本文),包括所述致动器的第一本体部分和第二本体部分,所述第一本体部分与所述第二本体部分之间形成压电材料,其中所述致动器至少部分置于所述外壳内。 [0025] Another embodiment of the present invention provides a bone marrow biopsy instrument, a bone marrow biopsy instrument having a housing and an actuator, for example a Langevin actuator (e.g., see U.S. Patent No. 6,491,708 to (to Madan et al.), the entire disclosure of which are incorporated by reference herein), comprising a first body portion and second body portion of the actuator, between the first body portion and the second body portion forming a piezoelectric material, wherein the at least partially disposed within the housing of the actuator. 本发明还包括把手和具有开口远端和开口近端的外套管,例如针,所述套管位于所述致动器的远端部分。 The present invention further comprises a handle and outer tube having an open distal end and an open proximal end, such as a needle, located at the cannula distal portion of the actuation of the actuator. 根据本实施例的一个方面中,本发明还包括管心针,所述管心针具有连接所述远端尖相对部分的所述把手的穿透远端尖,其中所述管心针可滑动穿过所述本体的中心腔和套管。 According to one aspect of the present embodiment, the present invention further comprises a stylet, said stylet having a penetrating distal tip relative to the distal tip of the connecting portion of the handle, wherein the stylet slidably central lumen through the body and the sleeve. 所述致动器的远端形成远端开口,所述致动器的近端形成近端开口, 中心空心孔从所述远端开口延伸至所近端开口,从而限定空心通道。 The distal end of the actuator distal opening formed in the actuator, the actuator proximal end defining a proximal opening of the actuator, the central hollow bore extending from the distal end opening to the proximal opening, thereby defining a hollow channel.

[0026] 更确切地说,所述外套管为固定连接所述致动器远端的空心管,使得所述套管的所述开口近端与所述致动器远端的远端开口一致。 [0026] More precisely, the outer cannula is fixedly attached to the distal end of the actuator is a hollow tube such that the open proximal end of the cannula with the distal end of the actuator distal end opening of the actuator consistent with . 所述管心针从所述近端通过所述空心通道和所述远端可滑动地置于所述致动器的中心。 The proximal end of the stylet from said passage and through said hollow distal end slidably disposed in the center of the actuator. 所述管心针具有预定长度,使得所述管心针可滑动地穿过所述外套管的中心,所述管心针的所述远端尖伸出所述套管的所述开口远端。 Said stylet having a predetermined length, such that the stylet slidably passes through the center of the outer sleeve, the tube distal tip of the stylet extends out of the distal opening of the cannula .

[0027] 本发明所述的各种致动器必须与外部电信号源电连接。 [0027] The various actuators of the present invention must be electrically connected to an external signal source. 经电信号启动后,所述致动器将信号转换为机械能,该机械能引起附着针或管心针等末端执行器的振动。 After starting an electric signal, said actuator signal is converted to mechanical energy, which can cause mechanical vibration of the end effector attached to a needle or other stylet. 如果是Langevin致动器,压电材料产生的振动产生通过整个组件的驻波,例如图17图形中的驻波。 If a Langevin actuator, vibration of the piezoelectric material generates a standing wave generated by the whole assembly, for example, a standing wave pattern in FIG. 17. 由于在给定频率下,驻波由连续零位移(节点或零节点)和最大位移(反节点,未显示)的位置组成,沿所述致动器的任何点产生的位移取决于测量位移的位置。 Since at a given frequency, a standing wave of a continuous zero-displacement (node, or zero node) and maximum displacement (anti-node, not shown) composed of position, displacement at any point along the actuator depends on the measurement of displacement generated position. 因此,通常电极臂的设计长度使得在操作所述装置时在反节点处提供所述电极臂的远端。 Thus, the electrode length is typically designed such that the distal end of the arm providing the electrode arms when operating the device in the opposite node. 这样,所述电极臂的所述远端会产生沿相对所述致动器长轴的纵向的大振动位移。 Thus, the distal end of the electrode along the arm relative to the actuator produces large vibration displacement in the longitudinal direction of the long axis of the actuator. 相反地,所述零节点是最适合增加孔开口或槽的位置,使得有可能连接外部装置与所述致动器。 Conversely, the zero node is the most suitable openings or slots to increase position, making it possible to connect an external device to the actuator. 如ZN线所示, 孔开口SP与零节点位置一致,零节点处的较小位移对所连接装置的磨损较小。 As shown in line ZN, openings consistent with the zero node position SP, the smaller the displacement zero at the node connecting means of abrasion is small.

[0028] 因此,在一个替代实施例中,所述致动器可形成有位于所述致动器远端的远端开口,位于致动器至少一部分上的开口及自所述远端开口延伸且与所述孔开口连通的空心孔。 [0028] Thus, in one alternative embodiment, the actuator may be formed at the distal end of the distal opening of the actuator, induced by the opening and positioned on at least a portion of the actuator extending from the distal opening and a hollow bore communicating with the openings. 优选地,所述孔开口可为所述致动器电极臂侧上的侧孔。 Preferably, the openings of the actuator may be a hole in the side-arm side actuator electrodes. 更优选地,所述孔开口通常位于所述致动器的零节点位置(最好位于中心),最优选地位于所述致动器电极臂侧的零节点位置中心。 More preferably, the aperture opening generally located at zero node location (preferably in the center) of the actuator, and most preferably at zero node location of the actuator center electrode-side arm actuator. 此外,一种用于指示身体位置(例如硬膜外腔)成功穿透的反馈装置,例如上述公开的任何一种传统反馈装置,通过连接所述孔开口位置或最好所述侧孔与本实施例连通。 Furthermore, one for indicating the position of the body (e.g. epidural space) successfully penetrate the feedback means, for example, any of the above disclosed conventional feedback device, preferably via a side hole connecting the present position of the hole or opening Example communicates embodiment. 或者,能输送流体的任何装置,例如导管或传统注射器,可连接所述孔开口位置或最好为所述侧孔。 Alternatively, any means capable of delivering a fluid, such as a catheter or a conventional syringe can be connected to the aperture or opening position of the side hole preferably.

[0029] 本发明通常涉及震荡或平移致动手持式器械,所述震荡或平移致动手持式装置用于穿透各种身体组织,以输送和清除体液、组织、营养物质、药物、治疗方法、放置或拨除导管等。 [0029] The present invention relates generally-held apparatus for penetrating a variety of body tissues, to deliver and remove fluids, tissues, nutrients, drugs, shock treatments or translational actuation handle-held device, the actuation handle or translational shocks , catheter placement or plucking. 例如,至于压电器械,本发明为一种手持件,所述手持件包括本体、置于所述本体内的至少一个压电元件和用于组织穿透的尖锐件(例如位于所述手持式器械远端部分的注射器、硬膜外针或活检针),且具有通过任何已知的检测机构(例如但不限于电气装置、磁性装置、压力装置、电容装置、感应装置等)提供视觉指示、听觉指示或触觉指示来指示成功穿透身体内间隙(例如硬膜外腔)的反馈装置。 For example, as for the piezoelectric devices, the present invention provides a handpiece, the handpiece includes a body, the body disposed at least one piezoelectric element and a sharp tissue penetrating element (e.g., the handheld located the distal end portion of the instrument syringe, epidural needle or biopsy needle), and having detected by any known means (e.g., but not limited to electrical, magnetic means, pressure means, capacitive means, sensing means, etc.) to provide visual indication, audible indication or a tactile indication to indicate successful penetration of the body space (e.g. epidural space) the feedback means.

[0030] 此外,由于使用正确电路,包括致动器的所述手持式医疗器械具有一种装置,所述装置用于在穿破特定组织或身体内部(例如硬膜外腔)时切断所述驱动致动器(例如一个或多个压电元件、音圈、螺线管、其他振荡致动器或平移致动器等)的外部电源。 [0030] Further, since the correct circuit comprising said actuator handheld medical device has means, said cutting means when worn for a particular tissue or internal body (e.g. epidural space) the driving the actuator (e.g., one or more piezoelectric elements, voice coil, solenoid, other oscillatory or translational actuator actuator, etc.) of an external power source. 用于切断所述驱动致动器外部电源的装置可作为上述装置的一部分实施,以提供视觉指示、听觉指 Driving means for severing the portion of the actuator may be used as the external power source apparatus embodiment, to provide a visual indication, audible means

9示或触觉指示或共同作为独立装置。 9 illustrates tactile indication or jointly or as a standalone device. 穿透特定组织或例如硬膜外腔内部后,最好通过将正确电路配置并入上述电气装置实现用于切断所述驱动致动器外部电源的装置,以触发切换装置,从而切断所述驱动致动器的电源。 Penetration of a particular tissue or internal, for example, after the epidural space, the cutting means is preferably implemented for the actuator of the external power drive in order to trigger the switching means to cut off the drive by means incorporated in the electric circuit is configured correctly actuator power actuator. 美国专利号为5,575,789中(Bell等人)描述此类装置,该专利的全部公开内容均以引用的方式并入本文。 In U.S. Patent No. 5,575,789 (Bell et al.) Describes such a device, the entire disclosure of which are incorporated by reference herein. 通过提供所述电气切断装置,成功穿透硬膜外腔,例如,临床医师收到穿透特定身体内部的一个或多个视觉指示、听觉指示和触觉指示及作为第二指示的器械电力损耗。 By providing the electric cutting apparatus, successful penetration of the epidural space, e.g., a clinician receives a specific internal body penetrate or more visual indication, an audible indication and a tactile indication and the second indication instrument power loss. 此外,如果通过切断所述驱动致动器电源而发生器械电力损耗,进一步穿破组织所需的力或向前动力会停止,反过来会减少不必要的身体区域穿刺(例如意外硬膜穿刺)的可能性。 Further, if the driving actuator by cutting the power supply device power loss occurs, the force required for further tissue perforation or stops forward momentum, which in turn will reduce unwanted body area puncture (such as accidental dural puncture) possibilities.

[0031] 此外,从体内收回所述穿透件时,具有具体控制电子装置的本发明提供减力。 [0031] Further, when the penetrating member withdrawn from the body, particularly with the present invention is to provide an electronic device control force reduction.

[0032] 在一个实施例中,所述穿透件或尖锐管状件是血管注射针的一部分。 [0032] In one embodiment, the penetrating or sharp tubular member which is part of a blood vessel injection needle.

[0033] 在另一实施例中,所述穿透尖锐管状件为Tuohy针。 [0033] In another embodiment, the penetrating sharp tubular member is a Tuohy needle.

[0034] 在又一实施例中,所述穿透件或尖锐管状件为套管针和管心针组件,例如JAMSHIDI® 活检针。 [0034] In yet another embodiment, the penetrating or sharp tubular member is a member trocar and stylet assembly, e.g. JAMSHIDI® biopsy needle.

[0035] 在又一实施例中,所述穿透件或尖锐管状件为铅笔尖针。 [0035] In yet another embodiment, the penetrating or sharp tubular member is a pencil sharp needle member.

[0036] 在又一实施例中,所述穿透件或尖锐管状件为套管针入孔的一部分。 [0036] In yet another embodiment, the penetrating or sharp tubular member is part of a trocar member into the hole.

[0037] 参阅本发明的各种示例性实施例的详细描述对本发明的所述特征和其他特征进行描述,或者该特征将变得明显。 [0037] Refer to detailed description of various exemplary embodiments of the present invention will be described and other features of the present invention, or that the feature will become apparent.

附图说明 BRIEF DESCRIPTION

[0038] 下面参考附图描述本发明的示例性实施例。 [0038] The following embodiments described with reference to exemplary embodiments of the present invention are shown.

[0039] 图1为现有技术的活检针远端的局部等距视图; [0039] FIG. 1 is a partial isometric view of the distal end of the biopsy needle prior art;

[0040] 图2为现有技术的硬膜外针远端的局部侧视图; [0040] FIG. 2 is a partial side view of the distal end of the epidural needle of the prior art;

[0041] 图加为传统、现有技术的低阻力注射器的平面图; [0041] FIG plus low resistance is a plan view of the conventional syringe, the prior art;

[0042] 图3为说明穿透件穿透力的图形; [0042] FIG. 3 is a graphical penetrating member penetrating;

[0043] 图4为用作本发明第一实施例中的致动器的Langevin致动器(通常称为Langevin传感器)的横截面; [0043] FIG. 4 is used as an actuator of the present invention in the first embodiment of the cross-section of a Langevin actuator (commonly referred to as Langevin sensor);

[0044] 图如为针设计,侧孔位于穿透件毂内,以便(例如)为压力传感器接头或导管置入位置提供外部入口。 [0044] FIG designed as a needle, penetrating the side holes are located within the hub member, so that (for example) providing an external pressure sensor to the inlet fitting or catheter placement position.

[0045] 图5为本发明第一实施例中使用的血管注射针的横截面; [0045] FIG. 5 is a cross-section of injectable needles used in the first embodiment of the present invention;

[0046] 图6为本发明第一实施例中使用的柱塞的横截面; [0046] FIG. 6 is a cross-section of the plunger used in the first embodiment of the present invention;

[0047] 图6a描述包括接线和外壳灭菌套的本发明; [0047] FIG 6a depicts the present invention comprises a housing and a terminal sterilization sleeve;

[0048] 图6b描述包括连接所述致动器末端的电池和逆变器室的本发明; [0048] FIG. 6b described with the present invention comprises connecting the actuator end of the battery and the inverter chamber;

[0049] 图7为本发明第一实施例的横截面; [0049] Figure 7 a cross-section according to the first embodiment of the present invention;

[0050] 图7a为本发明第一实施例的替代设计的横截面,本发明包含位于穿透件毂上的侧孔; [0050] FIG. 7a cross section of an alternative embodiment of the design of the first embodiment of the present invention, the present invention comprises a side hole is located on the penetrating member hub;

[0051] 图8为图7中本发明第一实施例的另一替代设计的横截面; [0051] FIG 8 is a cross-section 7 of the present invention is another example of a first alternate embodiment of the design;

[0052] 图9为本发明第二实施例的等距视图; [0052] FIG 9 an isometric view of a second embodiment of the present invention;

[0053] 图9a为第二实施例的替代设计的等距视图,通过所述致动器上的侧孔连接压力传感器的位置或置入导管;[0054] 图9b为第二实施例的更优选替代设计的等距视图,通过所述穿透件毂上的侧孔连接压力传感器的位置或置入导管; [0053] Figure 9a is an isometric view of an alternative design of the second embodiment, a pressure sensor connected to the position or place the catheter through the side holes of the actuator on the actuator; [0054] FIG. 9b is a second embodiment of the more an isometric view of a preferred alternative design, the pressure sensor or the connection position into the catheter through the side holes of the penetrating member hub;

[0055] 图IOa为用于本发明第三实施例中的内管心针的横截面; [0055] FIG IOa cross section for the inner stylet of the third embodiment of the present invention;

[0056] 图IOb为用于本发明第三实施例中的外部穿透件(例如套管针)的横截面; [0056] FIG. IOb the present invention is a cross-section of a third embodiment of the outer penetrator (e.g., a trocar) is;

[0057] 图IOc为显示图IOa的内管心针的相对位置的横截面,所述内管心针位于用于本发明第三实施例中的图IOb的外部穿透件内; [0057] FIG IOc is a cross-section of the relative positions of the stylet of FIG IOa, said inner stylet positioned within a third embodiment of the present invention, in the embodiment of FIG. IOb penetrating the outer member;

[0058] 图11为本发明第三实施例的横截面; [0058] Figure 11 cross section of a third embodiment of the present invention;

[0059] 图12为本发明第四实施例的横截面; [0059] FIG. 12 is a cross-section of the fourth embodiment of the present invention;

[0060] 图13为连接用于本发明第五实施例的放大型压电致动器的穿透件的横截面; [0060] FIG. 13 is an enlarged piezoelectric connected to a fifth embodiment of the present invention, a cross-section penetrating the actuator member of the actuator;

[0061] 图13a为本发明使用的具有侧孔的穿透件的替代APA设计的横截面; Alternatively the cross-sectional design APA [0061] FIG. 13a penetrating member of the present invention having a side hole;

[0062] 图14为本发明第五实施例的横截面; [0062] FIG. 14 is a schematic cross-section of a fifth embodiment of the present invention;

[0063] 图14a为本发明第五实施例的横截面,该实施例使用具有图13a的侧孔的穿透件; [0063] FIG 14a of the present embodiment of the cross-section of a fifth embodiment of the invention, this embodiment having a penetrating hole 13a of the side member of FIG;

[0064] 图15为本发明第六实施例的横截面,该实施例包括钹型致动器; [0064] FIG. 15 cross-section of a sixth embodiment of the present invention, this embodiment comprising a Cymbal actuator;

[0065] 图16为本发明第六实施例的横截面,该实施例使用具有图13a的侧孔的穿透件; [0065] Figure 16 a cross-section of a sixth embodiment of the present invention, this embodiment having a penetrating hole 13a of the side member of FIG;

[0066] 图17显示驻波零节点与Langevin致动器的侧孔位置之间的相关性,其中未显示致动器把手; [0066] FIG. 17 shows the correlation between zero node of the standing wave and the location hole side Langevin actuator, wherein the actuator knob not shown;

[0067] 图17a显示驻波零节点与连接Langevin致动器的穿透件的侧孔位置之间的相关性; [0067] FIG. 17a shows the correlation between zero node of the standing wave and the side hole connecting Langevin actuator member penetrating position;

[0068] 图18a为本发明第七实施例的功能图,该实施例描述Langevin致动器上零节点位置处的侧孔,其中未显示把手; [0068] Figure 18a is a functional diagram of a seventh embodiment of the present invention, this example describes the Langevin actuator side holes at zero node location of the actuator, wherein the handle is not shown;

[0069] 图18b为本发明第七实施例的功能图,该实施例包括与中心通道连通的图18a的侧孔,所述中心通道沿Langevin致动器的长度延伸,其中未显示把手; [0069] Functions of the seventh embodiment of the present invention, FIG. 18b, this embodiment includes a side aperture communicating with the central passage 18a of FIG, said central channel along the length of a Langevin actuator extends, wherein the handle is not shown;

[0070] 图18c为本发明第八实施例的简图,该实施例包括与针附件连通的两个侧孔,一个侧孔连接Langevin致动器的前部,另一个侧孔连接穿透件,其中未显示致动器把手。 [0070] FIG 18c of the present embodiment schematic view of an eighth embodiment of the invention, for example, two side holes communicating with the needle attachment include the embodiment, a side hole connecting the front portion of the Langevin actuator, connected to the other side hole penetrating member wherein the actuator is a handle not shown.

[0071] 图18d为本发明第八实施例的简图,该实施例包括连接短孔且与针附件连通的侧孔,所述侧孔也连接Langevin致动器的前部,其中未显示图18a的致动器把手; [0071] FIG. 18d schematic view of an eighth embodiment of the present invention, this embodiment includes a short-side connecting hole and in communication with the needle attachment hole, said side hole is also connected to the front portion of the Langevin actuator, which is not shown in FIG. an actuator handle 18a;

[0072] 图19为本发明第九实施例的附图,该实施例包括图加的传统注射器,所述传统注射器连接图18所示的致动器侧孔位置,其中未显示致动器把手; [0072] FIG. 19 of the present embodiment of the invention, the drawings of the ninth embodiment, FIG embodiment comprises a conventional syringe adding this embodiment, a conventional syringe connected to the actuator shown in FIG. 18, the position of the side hole, wherein the actuator handle is not shown ;

[0073] 图19a为本发明第九实施例的附图,该实施例包括图加的传统注射器,所述传统注射器连接图18c所示的穿透件毂的侧孔位置,所述致动器也连接所述穿透件毂,其中未显示致动器把手; [0073] Figure 19a embodiment of the present invention, the drawings of the ninth embodiment, the embodiment comprises a conventional syringe of FIG was added to the embodiment, the penetrating member hub side hole 18c of the position shown in FIG conventional syringe attachment, the actuator the penetrating member is also connected to the hub, wherein the actuator knob not shown;

[0074] 图19b为连接穿透件的压力传感泵的附图; [0074] The pressure sensor 19b is connected to the pump of FIG drawings penetrating member;

[0075] 图20a为本发明第十实施例的横截面视图,该实施例使用音圈作为驱动致动器; [0075] a cross-sectional view of a tenth embodiment of the present invention, FIG. 20a, this embodiment uses a voice coil actuator as a drive;

[0076] 图20b为本发明第十实施例的横截面视图,该实施例使用音圈作为驱动致动器, 其中磁性件和线圈的位置与图20a中磁性件和线圈的位置相反; [0076] a cross-sectional view of a tenth embodiment of the present invention, FIG. 20b, this embodiment uses a voice coil actuator as a drive, wherein the position opposite to the position of the magnetic member and the coil of FIG. 20a and the coil of the magnetic member;

[0077] 图20c为本发明第十实施例的等距横截面视图,该实施例使用两个线圈; [0077] FIG. 20c tenth embodiment isometric cross sectional view of the embodiment, this embodiment uses two coils embodiment of the present invention;

[0078] 图20d为本发明第十实施例的横截面侧视图,该实施例使用具有弹簧的螺线管; [0078] FIG. 20d present a tenth embodiment of a cross-sectional side view of the invention, this embodiment uses a solenoid with springs;

[0079] 图21为用于本发明各种实施例中的电源切断装置的示例性示意图。 [0079] FIG. 21 is a schematic diagram of an exemplary embodiment of the power supply cut-off apparatus of the various embodiments of the present invention. 具体实施方式 detailed description

[0080] 图3至图21说明本发明的优选实施例,相同的数字表示相同和相应元件。 [0080] Figures 3 to 21 illustrate preferred embodiments of the present invention, like numerals indicate like and corresponding elements. 为了描述本发明各种元件的相对配置,术语“远端”、“远端地”、“近端”或“近端地”的狭义定义不会只指特定严格方向,而是用作站位符定义相对位置,根据上下文使用附图和参考数字定义所述相对位置。 In order to describe the relative configuration of various elements of the present invention, the term "distal", "distally", "proximal" or "proximally" refers only to the narrow definition does not strictly specific direction, but as stations define the relative position of the character, depending on the context and the drawings reference numerals defining the relative position. 本说明书结尾提供各种参考标签的列表。 End of the specification provides a listing of the various reference labels. 此外,2008年6月27日申请的标题为“减小穿透力用医疗工具”的美国ASN号为12/163,071的全部内容均以引用的方式并入本文。 In addition, the title June 27, 2008 to apply to "reduce penetration with medical tool," the entire contents of the US ASN No. 12 / 163,071 is incorporated herein by reference are.

[0081] 例如,上述优选实施例所述的本发明的有效性利用减力优化穿透人体内找到的组织或物质。 [0081] For example, using a force reduction effectiveness of the present invention to optimize the above-described preferred embodiment of the penetration of tissue or substance found in the human body. 实际上,器械穿透件部分(例如针)的高速操作穿透组织时,进入所需的力减小。 In fact, the instrument portion penetrating member (such as a needle) to penetrate tissue when the high-speed operation, the force required for entry is reduced. 换句话说,穿透件(也称为“管状件”),例如针,在插入过程中轴向振动(例如往复运动)时,可观察减力效应,且出现足以打破组织与穿透件之间的粘结的机械能。 In other words, penetrating member (also referred to as "tubular member"), such as needles, during the insertion of axial vibration (e.g. a reciprocating motion), force reduction effect can be observed, and the occurrence of tissue penetrating member sufficient to break the the bond between the mechanical energy. 如果出现所需的针位移量,在声波至超声波频率范围内可达到机械能的阈值极限。 If the amount of displacement of the needle required to appear in the sonic to ultrasonic frequency range up to the threshold limit mechanical energy.

[0082] 为了利用减力效应,设计本发明的医疗器械设计为使穿透远端尖部分实现短行程距离或位移,并以高穿透频率正弦振动。 [0082] In order to utilize force reducing effect, the design of medical devices that the present invention is designed to penetrate the distal end tip portion to achieve short travel distance or displacement, and high-frequency sinusoidal vibration penetration. 利用如上述实施例所述的各种器械配置,已确定所述尖锐远端尖的正弦运动必须包括压电工具以20-50kHz (最优选为20-25kHz)频率实现;35-100 μ m位移,更优选为50-100 μ m。 Apparatus arranged as described above using various embodiments of the embodiment, it has been determined that the sinusoidal motion of the sharp distal tip must include a piezoelectric tool implemented in 20-50kHz (most preferably 20-25kHz) frequency; 35-100 μ m Displacement , more preferably 50-100 μ m. 连接以50-150Vpp/mm(最优选为90Vpp/mm)运行的致动压电致动器的穿透件20引起所述运动,Vpp称为峰间电压。 Connected to 50-150Vpp / mm (most preferably 90Vpp / mm) running penetrating member actuation of the piezoelectric actuator 20 causes the movement, Vpp peak to peak voltage called.

[0083] 例如,图3显示阻力相对于骨活检针穿入硬组织的深度的图示。 [0083] For example, Figure 3 shows the resistance with respect to the depth of penetration of the biopsy needle illustrating the bone hard tissue. 在图3中,曲线标示A表示针在“关闭”或非振动状态下的数据,曲线标示B表示具有针的医疗器械的数据, 所述针通过频率为38kHz、位移量为100 μ m的压电致动器振动。 In FIG. 3, the curve labeled A needle when data "off" or non-vibration state representation, the curve labeled B represents data having a needle medical device, the needle by a frequency of 38kHz, the amount of displacement of 100 μ m pressure electric actuator vibration. 可从图3明显看出,曲线B 显示在不振动的情况下,穿入物质所需的力远高于振荡针所需的力,例如曲线B表示的力。 As apparent from FIG. 3, the curve B shows without vibration, the force required to penetrate the material is much higher than the force required for the oscillating needle force curve B represents the example.

[0084] 仅举例而言,参考图4,LangeVin致动器(通常以数字100表示)包括压电致动器, 该压电致动器包括具有中心空心通道的本体、可移置件(也称为“电极臂”)110、锚(也称为“背部固定块”)112和至少一个压电元件114,但最好包括多个压电元件114。 [0084] By way of example only, with reference to FIG. 4, LangeVin actuator (generally represented by numeral 100) comprises a piezoelectric actuator, the piezoelectric actuator comprising a hollow body having a central passage, the displaceable member (also called "horn") 110, an anchor (also referred to as "fixed back block") 112 and at least one piezoelectric element 114, but preferably comprises a plurality of piezoelectric elements 114. 具体地,各压电元件114形成压电环,该压电环形成空心部分,其中压电元件114固定在本体内,并连接在电极臂110与背部固定块112之间。 Specifically, each of the piezoelectric element 114 is formed of the piezoelectric ring, the piezoelectric ring to form a hollow portion, wherein the piezoelectric element is fixed in the body 114, and is connected between the horn 110 and rear mass 112. 空心或实心螺栓116置于背部固定块112的中心部分,贯穿至少一个压电元件114的中心部分延伸,然后在电极臂110的中心部分终止。 Hollow or solid portion of the fixing bolt 116 at the center of the back block 112, at least throughout a central portion of the piezoelectric element 114 extends, and terminates in the central portion 110 of the horn. 螺栓压缩背部固定块112、至少一个压电元件114和电极臂110。 Compression bolt rear mass 112, the at least one piezoelectric element 114 and the horn 110. 电极臂110和背部固定块112 由金属(例如钛、不锈钢)、陶瓷(包括多晶和单晶无机材料)、塑料、复合材料制成,或最好由铝制成。 Horn 110 and rear mass 112, ceramics (including polycrystalline and single crystal inorganic materials), plastic, metal (e.g. titanium, stainless steel) composite material, or preferably made of aluminum. 螺栓116由与电极臂110和背部固定块112相同的材料制成。 A bolt 116 is made of the same horn 110 and rear mass 112 material. 为了防止患者和临床医师受到电击,Langevin致动器100的至少一部分、最好是至少整个后部本体112、所有至少一个压电元件114和电极臂110的至少一部分均置于把手118内。 In order to prevent the patients and clinicians by electric shock, at least a portion of the Langevin actuator 100 of actuator, preferably at least the entire rear body 112, at least a portion of all the at least one piezoelectric element 114 and the horn 110 of the handle 118 are placed. 在至少一个压电元件114的相对面之间形成的金属标签(未显示)处进行电气连接。 Metal tag is formed between opposing faces of the at least one piezoelectric element 114 (not shown) for electrical connections. 可通过连接交流电源或电池(例如位于本发明的电池室内)的电导体114b耦合该标签。 By connecting the AC power source or battery (e.g. located in the battery chamber of the present invention) 114b electrically coupled to the conductor tab. 把手118包括外壳部分和密封件120,该外壳部分可为塑料或金属,密封件120可为弹性体。 118 comprises a handle 120, the housing portion may be a plastic or metal, the sealing member 120 may be a housing portion and an elastomeric seal member. 密封件120防止水分从背部固定块112、压电元件114和电极臂110的中心部分进出。 Seal 120 prevents moisture out from the central portion of the rear mass 112, piezoelectric element 114 and the horn 110. 背部固定块112、压电元件114和电极臂110的中心部分与螺栓116的空心部分一致,螺栓116在Langevin致动器100内形成连续孔126,孔1¾具有位于远端面121的远端开口122和位于远端面121对面的近端开口124。 Rear mass 112, the central portion 126 continuous with the bolt hole of the hollow portion 116 coincide, the bolt 114 and the electrode 116 of the piezoelectric element 110 is formed in the arm Langevin actuator 100, having a distal bore at the distal end surface of 1¾ opening 121 at the distal end 122 and proximal surface 121 opposite the opening 124. 该致动器加设鲁尔锥形头123,以使连接清晰。 The actuator plus luer tapered head 123 is provided to clear the connection.

[0085] 应了解的是,压电元件114的数量并不构成对本发明的限定,在本发明的广泛范围之内,包括一个或多个压电元件114。 [0085] It should be appreciated that the number of the piezoelectric element 114 is not intended to limit the present invention, within the broad scope of the present invention, comprises one or more piezoelectric elements 114.

[0086] 根据一个替代实施例,可在该致动器的电极臂110侧形成侧孔(未显示),连续孔126从远端面121处的远端开口122延伸并与该侧孔连通。 [0086] According to an alternative embodiment, the side hole may be formed on the electrode 110 side of the actuator arm (not shown), the continuous bore 126 extends from a side hole in communication with the distal surface of the distal end 121 of the opening 122.

[0087] 所述医疗器械的功能性能由压电元件部分驱动。 [0087] The functional performance of the medical device is driven by the piezoelectric element portion. 压电元件114,例如一个或多个压电材料环能精确、受控位移,并能以特定频率产生能量。 The piezoelectric element 114, for example, one or more piezoelectric material rings can be precisely controlled displacement and can generate energy at a particular frequency. 由于晶体结构的不对称性,压电材料暴露于电气输入中时会以称为逆压电效应而膨胀,在负电压下也可能发生收缩。 Due to the asymmetry, the crystal structure of the piezoelectric material is exposed to will be referred to as the reverse piezoelectric effect when an electrical input expansion, shrinkage may occur at a negative voltage. 通过压电系数d33、d31和d15乘以电场E量化压电应变,以确定所述材料感应的应变χ。 Piezoelectric coefficient d33, d31 and d15 piezoelectric field is multiplied by quantization strain E to determine the strain induced in the material of the χ. 铁电多晶材料,例如钛酸钡(BT)和锆钛酸铅(PZT)受电极化时呈现压电性。 Ferroelectric polycrystalline material, for example by the electrode exhibits piezoelectricity when barium titanate (BT) and lead zirconate titanate (PZT). 由磁盘或多层型组成的简单器械直接使用材料通过外加电场感应的应变。 Simple devices composed of a disk or a multilayer type directly use the material by the applied electric field induced strain. 在压电器械的机械谐振频率下调谐的交变场可产生声学振动和超声振动。 Tuned at the mechanical resonance frequency of the piezoelectric device can produce alternating field and ultrasonic vibration acoustic vibrations. 压电组件可制成各种形状和尺寸。 A piezoelectric element can be made of various shapes and sizes. 在一个实施例中,压电组件可为2-5mm(直径)、3_5mm(长),可有几个叠环、磁盘或板组成。 In one embodiment, piezoelectric component may be 2-5 mm (diameter), 3_5mm (length), there may be several stacked rings, disks or plates. 该压电组件的精确尺寸依赖于性能。 The exact dimensions of the piezoelectric component depends on performance. 压电单晶或多晶材料可由锆钛酸铅(PZT)、多层PZT、铌镁酸铅-钛酸铅(PMN-PT)、多层PMN-PT、锌铌酸铅-钛酸铅(PZN-PT)、聚偏二氟乙烯(PVDF)、多层PVDF和其他铁电聚合物中的至少一种组成。 The piezoelectric single crystal or polycrystalline material may be lead zirconate titanate (PZT), multilayer PZT, lead magnesium niobate - lead titanate (PMN-PT), multilayer PMN-PT, lead zinc niobate - lead titanate ( PZN-PT), polyvinylidene fluoride (PVDF), multilayer PVDF, and other ferroelectric polymers composed of at least one. 还可掺杂上述材料,以改变所述医疗器械的特性和提高其性能。 The above materials may also be doped, to change the characteristics of the medical device and improve its performance. 所述列表并不包括所有可能的压电材料。 The list does not include all possible piezoelectric material. 例如,已有关于无铅(Pb)材料的大量研究,该无铅(Pb)材料一经研发,就能在本发明中使用。 For example, there have been numerous studies on lead (Pb) material, the lead (Pb) by a developing material, can be used in the present invention.

[0088] 在图如所示的实施例中,侧孔SP位于空心针130穿透件毂525上。 [0088] In the embodiment as shown in FIG embodiment, the side port SP located on the hollow needle 130 penetrating member hub 525. 在该替代实施例中,空心针130穿透件毂525最好为金属或模塑金属插入件的组合。 In this alternative embodiment, the hollow needle 130 penetrating member hub 525 is preferably a combination of a metal or a metal insert molding. 侧孔SP应包含连接低阻力传统注射器PA3的内螺纹鲁尔锥形开口。 Side port SP should be low resistance connections comprising an internally threaded Luer conventional syringe PA3 tapered opening.

[0089] 现参考图5,用于本发明第一实施例中的穿透件(通常以数字20表示)包括连接配件128,连接配件1¾连接穿透组织的空心针130的近端130b和远端130a。 [0089] Referring now to Figure 5, a penetrating member in the first embodiment of the present invention (generally indicated at numeral 20) includes a connection fitting 128, connected to the proximal end connection fitting 130b 1¾ hollow needle 130 to penetrate tissue and far end 130a. 仅举例而言, 连接配件1¾可包括鲁尔锥形物、塑料或金属配件。 By way of example only, the connector may include a luer fitting 1¾ taper, plastic or metal parts.

[0090] 现参考图6,用于本发明第一实施例中的柱塞12包括连接柱塞轴134近端13½的柱塞把手132和连接柱塞轴134远端134b的柱塞密封件136。 [0090] Referring now to Figure 6, a handle for a plunger connected to the proximal end of shaft 134 of the plunger 132 and the plunger seal 13½ member 136 connected to the distal end 134b of the plunger shaft 134 of a first embodiment of the plunger of the embodiment of the present invention comprises 12 . 该柱塞密封件用于密封把手118,以便污染物(例如水或体液)不会达到该致动器元件或电气接头。 The plunger seal for sealing the handle 118, so that contaminants (e.g., water or body fluid) does not reach the actuator elements or electrical connections. 在另一个实施例中,该柱塞会在所述空心穿透件内形成真空,以抽出体液和/或组织,例如用于软组织活检术抽样。 In another embodiment, the plunger will be a vacuum within the hollow penetrating member, to extract fluids and / or tissue, for example, a soft tissue biopsy samples.

[0091] 在最优选实施例中,侧孔位于端连接点处的穿透件毂525上。 [0091] In a most preferred embodiment, the side hole is located on the penetrating member hub 525 is connected to the end point.

[0092] 现参考图7,本发明第一实施例,例如穿透导入器(通常以数字200表示)包括致动器,例如图4所示的Langevin致动器100,图5的穿透件20连接所述致动器的远端面121。 [0092] Referring now to Figure 7, a first embodiment of the present invention, e.g. penetrating introducer (represented by numeral 200 generally) comprises an actuator, for example, as shown in FIG. 4 Langevin actuator 100, FIG. 5 penetrating member the actuator 20 is connected to the distal face 121. 针连接配件1¾为螺纹配件,鲁尔圆锥接头、压缩配件或类似配件,且将空心针130耦合到部分远端面121上,使其与连续孔1¾的远端体积连通。 1¾ pin connector fitting is a threaded fitting, Luer taper fitting, compression fitting or similar fitting, and the upper portion of the hollow needle 130 is coupled to the distal face 121, it communicates with a distal volume of continuous pores 1¾. 柱塞把手132可螺纹连接、夹紧、压缩螺栓116,以固定图6的柱塞12。 The plunger handle 132 may be a threaded connection, clamping, compression bolts 116, to secure the plunger 12 in FIG. 6. 本发明可通过蒸汽灭菌法、灭菌套、伽玛射线、乙撑氧(ET0)等进行灭菌。 The present invention can be obtained by steam sterilization, sterilization units, gamma radiation, ethylene oxide (ET0) like sterilized. 例如,图6a描述用于连同本发明使用的接线和外壳的灭菌套115。 For example, FIG. 6a together with the description, serve junction housing used in the invention and sterilization sleeve 115. 针连接配件128的优选材料为金属或模塑金属插入件。 Preferred materials pin connector fitting 128 is a metal or insert molding metal. 图6b显示Langevin致动器100, Langevin致动器100具有连接该致动器端的电池和逆变器室117的可能配置。 Figure 6b shows a Langevin actuator 100, Langevin actuator 100 having a battery and an inverter connected to the actuator chamber end 117 may be disposed.

[0093] 回到图4和图7,向至少一个压电元件114施加预定频率的外部交变电流后, [0093] Returning to FIG. 4 and FIG. 7, the outside predetermined frequency alternating current is applied to the at least one piezoelectric element 114,

13Langevin致动器100以正弦方式反应性地改变形状,因此,通过预定位移改变相对通过螺栓116连接固定就位的柱塞把手132固定位置的远端面121的相对位置。 13Langevin actuator 100 in a sinusoidal manner reactivity change shape, and therefore, the relative position of the bolt 116 is connected to plunger handle 132 is fixed in place in a fixed position by the distal end surface 121 by a predetermined varying the relative displacement. 由于交变电流为正弦信号,激活压电元件114的结果是电极臂110远端面121的正弦来回运动和随后针130 的来回运动,从而减小穿透组织所需的力。 Since the alternating current is a sinusoidal signal, the result of the activation of the piezoelectric element 114 is a sinusoidal electrode distal face 121 of the arm 110 and then moved back and forth movement of the needle 130 back and forth, thereby reducing the force required to penetrate tissue. 如前所述,可从耦合逆变器(例如振荡器/放大器等)的直流电源(例如机载电池)或交流电源直接提供交流通电,所述逆变器反过来耦合压电元件114。 As described above, can be coupled from the inverter (e.g., oscillator / amplifier, etc.) of the DC power source (e.g., onboard batteries) or AC power directly supplied AC power, the inverter 114 in turn coupled to the piezoelectric element. 由于接线和接头需要更多灭菌特性,所述直流电源为更优选实施例。 Since the wiring connector needs more and sterilizing properties, the DC power supply is a more preferred embodiment.

[0094] 图7a描述如图7所示的类似发明,但包括具有连接空心针130的侧孔SP的穿透件毂525。 [0094] FIG 7a depicts a similar invention as shown in FIG. 7, but includes a penetrating member hub 525 has a side port SP connected to the hollow needle 130. 所述配置使压力传感器能安装在侧孔SP内,一旦拆卸侧孔SP,就会提供待插入导管或移除流体。 The configuration of the pressure sensor can be mounted in the side port SP, the side port SP once disassembled, will provide a catheter to be inserted or removed fluid. 由于导管或流体不会穿过致动器而仅通过制造为一次性使用的空心针130, 整个运行的器械不会有污染风险,所以与图7相比,这可能是优选实施例。 Since the catheter or fluids do not pass through the actuator only the hollow needle is manufactured by a single-use 130, the entire operation of the device will not have the risk of contamination, as compared with FIG. 7, this may be a preferred embodiment.

[0095] 参考图8,配套导入器(通常以数字201表示)与图7的穿透导入器200类似,所述配套导入器还包括作为,例如平坦部分存在的支撑翼111,用户可紧握支撑翼111,如下文中图17所述,支撑翼111从形成电极臂110机械零节点的外表面径向延伸。 [0095] Referring to Figure 8, matching introducer (generally indicated at numeral 201) similar to FIG. 7 penetrating introducer 200, the introducer further includes a support, for example, the presence of the flat portion support wing 111, the user can grip support wings 111, as described below in FIG. 17, the support wings 111 extend radially outer surface forming a mechanical zero node electrode 110 from the arm. 侧孔SP(未显示)可从所述支撑翼顺时针或逆时针旋转90度,这可能是提供引流样品收回、导管插入等的位置。 The side port SP from the position of the rotatable support wings 90 degrees clockwise or counterclockwise, which sample may be withdrawn to provide drainage, catheterization and the like (not shown).

[0096] 在本发明的替代实施例中,图8的穿透导入器201作为如图9所示的导管插入器(通常以数字202表示)存在。 [0096] In an alternative embodiment of the present invention, FIG. 8 penetrating introducer as the introducer catheter 201 (generally represented by numeral 202) shown in Figure 9 is present. 在本实施例中,与其从所述器械近端导入柱塞,还不如从所述器械近端导入导管129,然后通过如图4所示的孔1¾容纳导管129,导管1¾可穿过空心针130。 In the present embodiment, the device introduced from its proximal end of the plunger, not as the introduction catheter 129 from the proximal end of the instrument, and then receiving the catheter 129 through the aperture 1¾ shown in Figure 4, the catheter can be passed through the hollow needle 1¾ 130. 空心针130插入患者体内后形成皮下通道,导管1¾通过所述皮下通道导入体内。 After the hollow needle 130 into the patient subcutaneous tunnel is formed, the catheter into the body through the 1¾ subcutaneous tunnel. 成功导入后,可通过从电极臂110去耦连接配件1¾分离所述致动器与空心针130。 After successfully imported, 1¾ be separated by decoupling arm 110 from the electrode fitting connected to the actuator 130 and the hollow needle.

[0097] 图9a显示更优选实施例202b,侧孔SP允许导管1¾导入本发明,而不通过如图9 所示的所述近端。 [0097] Figure 9a shows a more preferred embodiment 202b, the side port SP of the present invention allow the catheter 1¾ introduced without passing through the proximal end 9 as shown in the FIG. 所述配置使压力传感器能安装在侧孔SP内,一旦拆卸侧孔SP,就能插入导管或清除所述器械远端面121附近的流体。 The configuration of the pressure sensor can be mounted in the side port SP, the side port SP once detached, can be inserted or remove fluid conduit 121 near the distal end of the instrument surface. 由于导管或流体不会穿过整个致动器,整个运行的器械不会有污染风险,所以与图9相比,更优选实施例202b很可能是优选实施例。 Since the catheter or fluids do not pass through the entire actuator, the entire operation of the instrument will not have the risk of contamination, as compared with FIG. 9, a more preferred embodiment 202b is likely to be a preferred embodiment.

[0098] 在如图9b所示的最优选实施例202c中,位于穿透件毂525上的侧孔SP允许压力传感器安装在侧孔SP内,一旦拆卸侧孔SP,就会提供仪器(例如导管129)插入或引流流体的入口。 [0098] In a most preferred embodiment shown in FIG. 9b 202c embodiment, the side port SP located on the penetrating member hub 525 allows the pressure sensor is mounted in the side port SP, the side port SP once disassembled, will provide the instrument (e.g. conduit 129) is inserted into the inlet or fluid drainage. 由于导管或流体不会穿过致动器,只有空心针130穿过致动器,整个运行的器械不会有污染风险,所以与图9相比,最优选实施例202c很可能是优选实施例。 Since the catheter or fluids do not pass through the actuator only the hollow needle 130 through the actuator, the overall operation of the device will not have the risk of contamination, as compared with FIG. 9, the most preferred embodiment 202c is likely to be the preferred embodiments .

[0099] 现参考图10a,内管心针(通常以数字14表示)包括连接内管心针轴144近端的内管心针针柄142。 [0099] Referring now to Figure 10a, the inner stylet (generally indicated at numeral 14) includes a proximal end 144 connected to the inner stylet shaft 142 stylet needle handle. 针柄142对面的内管心针轴144远端处为尖锐的内管心针尖146。 The inner stylet shaft 144 at the distal end of the needle shaft 142 opposite the sharpened inner stylet tip 146. 为了支撑内管心针轴144,如图IOb所示的外套管针管(通常以数字15表示)包括连接外套管针本体150近端的套管针连接配件148,套管针连接配件148为另一端的管状结构开口。 To support the inner stylet shaft 144, as shown in FIG outer trocar tube IOb of (usually expressed as number 15) comprising a needle cannula 150 connected to the proximal end of the outer sleeve of the needle body connecting parts 148, trocar 148 is connected to another fitting opening an end of the tubular structure. 套管针连接配件148是空心的,以致外套管针本体150可置于其中。 The trocar is hollow joint fitting 148, such that outer trocar body 150 can be placed. 此外,形成于套管针本体150另一端的开口的其中之一为远端套管针开口152,其外壁形成远端套管针尖154。 In addition, an opening is formed in one of the other end 150 of the trocar body distal trocar opening 152, the outer wall forming tip 154 ​​distal sleeve. 如图IOc所示,内管心针轴144可滑动置于具有内管心针尖146的外套管针本体150内,内管心针尖146伸出远端套管针尖154。 FIG IOc, the inner stylet shaft 144 slidably disposed within outer trocar body 150 with inner stylet tip 146, the inner stylet tip 146 extends beyond the distal tip of the cannula 154. 图IOa所示的内管心针14与图IOb所示的外套管针管15共同形成类似于套管针的结构(例如JAMSHIDI®活检工具)。 FIG IOa inner stylet 14 shown in FIG IOb outer trocar tube 15 shown collectively form a structure similar to a trocar (e.g. JAMSHIDI® biopsy tool).

[0100] 现参考图11,内管心针14可滑动置于图4所示Langevin致动器100和图IOb所示外套管针管15的孔126内,外套管针管15连接电极臂110,形成骨活检器械(通常以数字300表示)。 [0100] Referring now to Figure 11, the inner stylet 14 is slidably disposed within the bore shown in FIG Langevin actuator 126 of outer trocar tube 15, outer tube 15 is connected to the needle electrode arm 110 shown in FIG. 4 and IOb of actuator 100, are formed bone biopsy instrument (generally indicated at numeral 300). 内管心针14以某种方式延伸,因此,把手142完全就位时接触螺栓116,内管心针轴从把手142延伸,穿过外套管针本体150的近端开口124、孔1¾和空心部分,最后作为内管心针尖146在远端套管针尖154以外的位置处终止。 The inner stylet 14 extends in a certain way, and therefore, the handle 142 contacts bolt 116 when fully seated, the inner stylet shaft extending from the handle 142, the outer sleeve through the proximal opening 124 of the needle body 150, and the hollow hole 1¾ section, and finally as an inner stylet tip 146 at the distal tip of the cannula 154 at a position other than the termination. 在本实施例中,图4所示Langevin致动器100的至少一个压电元件114通过预定频率以电导体114b电驱动时,环压缩和膨胀形式的运动转移到电极臂110远端面121处的反节点位置。 In the present embodiment, the at least one piezoelectric element 114 Langevin actuator 100 as shown in FIG. 4 by a predetermined frequency to drive electrical conductor 114b, cyclic compression and expansion in the form of a motion transfer arm 110 to the distal end surface of the electrode 121 the anti-node position. 然后所述运动转移为驱动图IOb所示的外套管针管15。 The motion is then transferred as shown in FIG. IOb overtube driving needle 15.

[0101] 在一个替代实施例中,图12所示的高级骨活检器械(通常以数字400表示)包括图11所示骨活检器械300的所有元件,除了以预定频率电驱动图4所示Langevin致动器100后,所述运动转移为内管心针14的驱动。 [0101] In an alternative embodiment, FIG advanced bone biopsy instrument (usually numeral 400) shown in Figure 11 includes all the elements of bone biopsy device 300, as shown in FIG. 12 in addition to the predetermined frequency of the electrical drive of FIG. 4 Langevin after the actuator 100, the motion of the transfer drive 14 of the stylet. 为了执行所述功能,图IOa所示内管心针轴14和图IOb所示外套管针管15的位置与图11的配置相反。 To perform the function, the inner tube shown in FIG IOa stylet shaft 14 and disposed opposite to a position shown in FIG. IOb FIG outer trocar tube 15 11. 例如,在高级骨活检器械400 中,外套管针管15连接螺栓116。 For example, in the advanced bone biopsy device 400, outer trocar tube 15 is connected to a bolt 116. 此外,内管心针14延伸使得把手142完全就位时接触电极臂110远端面121,内管心针轴144从把手142延伸,穿过外套管针本体150的远端开口122、孔1¾和空心部分,最后作为内管心针尖146在远端套管针尖154以外的位置处终止。 In addition, the extension 14 such that the inner stylet handle 142 fully contact electrode arm 110 in place when distal face 121, the inner stylet shaft 144 extending from handle 142, the needle body through the distal end 150 of the outer sleeve opening 122, holes 1¾ and the hollow portion, and finally as an inner stylet tip 146 at the distal tip of the cannula 154 at a position other than the termination.

[0102] 尽管已就作为致动机构的Langevin致动器100描述了所述实施例,但本发明并不局限于此。 [0102] Although the actuator 100 has been described as to the Langevin actuator mechanism of the embodiment, but the present invention is not limited thereto. 例如,如图13所示,具有穿透件513尖锐远端尖51¾的空心管状结构的近端513a连接放大型压电致动器(APA) 510,形成APA针(通常以数字16表示)。 For example, as shown in FIG. 13, a hollow tubular structure having a proximal end 513a of the sharpened distal tip of penetrating member 513 connected 51¾ amplified piezoelectric actuator (APA) 510, APA needle form (generally indicated at numeral 16). 放大型压电致动器(APA) 510包括框架512和压缩在框架512内的压电材料514,框架512通常由金属(例如黄铜或不锈钢)制成。 Amplified piezoelectric actuator (APA) 510 comprises a frame 512 and compressing the piezoelectric material 514 in the frame 512, the frame 512 is generally made of a metal (e.g., brass or stainless steel). APA孔5¾可从远端面延伸,穿过压电材料514和框架512 的近端面51加。 APA bore may extend from the distal end surface 5¾, through the proximal surface of the piezoelectric material 514 and the frame 512 plus 51. 空心穿透件513,例如皮下注射针,连接框架512的远端面512b,使得空心部分与APA孔526同心对准。 Hollow penetrating member 513, for example a hypodermic needle, connected to a distal surface 512b of the frame 512, so that the hollow portion 526 concentrically aligned with the APA bore. 如图14所示,APA针16可置于把手518内,形成APA注射器(通常以数字500表示)。 As shown, APA needle 16 within the handle 14 may be positioned 518, the syringe is formed APA (generally indicated at numeral 500). 对本实施例来说,重要的是,放大型压电致动器(APA)510的框架512近端面51¾必须在如图所示的连接点516处固定到把手518内部,因此,APA孔526、 空心穿透件513、把手近端开口5¾和把手远端开口521形成连续通道,流体可通过该连续通道流入患者。 Embodiment of the present embodiment, it is important that the frame 512 proximal face 51¾ amplified piezoelectric actuator (APA) 510 must be fixed to the interior of the handle 518 at a connection point 516 as shown, therefore, the hole 526 APA , hollow penetrating member 513, the proximal end of the handle and the handle opening 5¾ distal opening 521 form a continuous channel through which fluid may flow into a patient a continuous channel. 图13a和1½分别显示替代实施例16b和500b,可拆卸穿透件毂525使一次性穿透件具有可再次使用的主动运动把手,其中穿透件毂525如前所述。 1½ 13a and 16b show alternative embodiments and 500B, a detachable penetrating member hub 525 having a penetrating member disposable reusable active motion handle where the penetrating member hub 525 as previously described.

[0103] 运行时,压电材料514在交流电压周期内膨胀,使相对形成的框架近端面和远端面512a、512b朝彼此向内移动。 [0103] operation, the piezoelectric material 514 expands within the alternating voltage period, the frame opposite the proximal and distal faces of the formed 512a, 512b move inwardly toward each other. 相反地,压电材料514在相反交流周期内压缩时,框架近端面和远端面512a、512b发生彼此分离的向外位移。 Conversely, when the piezoelectric material 514 compressed within the opposite AC cycle, the frame proximal and distal faces 512a, 512b separated from each other outward displacement occurs. 然而,在本实施例中,该框架的近端面512a固定连接本体518的连接点516,因此,压电材料堆的任何运动只会使远端面512b相对运动,从而使穿透件513运动。 However, in the present embodiment, the body is fixedly connected to the proximal face 512a of the frame 518 is connected to a point 514, thus, any movement of the stack of piezoelectric material will cause relative movement of the distal end surface 512b, so that the movement of the penetrating member 513 .

[0104] 适用放大型压电致动器(APA)的两个实例是非铰接式致动器和带槽或铰接式致动器。 [0104] applicable amplified piezoelectric actuator (APA) two instances of the actuator and a non-articulated or articulated slotted actuator. 美国专利号为6,465,936(KnOWleS等人)描述了铰接式或带槽APA实例的力学、操作和设计细节,其全部内容均以引用的方式并入本文。 U.S. Patent No. 6,465,936 (KnOWleS et al.) Describes the mechanics, operation and design details articulated or grooved APA instance, the entire contents of which are incorporated by reference herein. 非铰接式APA的实例为Cedrat Piezo 产品目录“Piezo致动器和电子产品”中所述、由Cedrat Technologies公司销售的Cedrat APA50XS (Cedrat Technologies 版权所有,2005 年6 月)。 Examples of non-hinged APA is Cedrat Piezo Products Catalog "Piezo actuators and electronic products" in the sold by Cedrat Technologies company Cedrat APA50XS (Cedrat Technologies Copyright, June 2005).

[0105] 优选地,本发明的APA在100Hz至20kHz频率范围内操作,更优选为100Hz至IkHz。 [0105] Preferably, the present invention APA in operating frequency range 100Hz to 20kHz, more preferably 100Hz to IkHz.

[0106] 或者,本发明的致动器可为钹型致动器。 [0106] Alternatively, the actuator of the present invention may Cymbal actuator is. 例如,在图15中,钹型注射器(通常以数字600表示)包括钹型致动器610,钹型致动器610包括具有远端端盖612b和近端端盖61¾的两个端盖612,所述端盖之间形成至少一个压电元件514。 For example, in FIG. 15, Cymbal syringe (usually expressed as number 600) comprising a Cymbal actuator 610, Cymbal actuator 610 includes an end cap having a distal end and a proximal end 612b of the two end caps 612 cover 61¾ , at least one piezoelectric element 514 is formed between the end caps. 所述钹型注射器位于钹型孔626的中心。 The Cymbal syringe is located in central bore 626 Cymbal. 端盖612增强对电气输入的机械响应,或相反地增强机械负荷产生的电气输出。 Endcaps 612 enhance the mechanical response to an electrical input, or conversely enhance the electrical output generated by a mechanical load. Meyer Jr. ,RJ等人在“使用钹型弯张传感器的电活性材料的位移放大”,传感器和致动器A 87 0001),157-162中描述了致动器技术细节。 Meyer Jr., RJ et al., "Displacement electroactive material used Cymbal flextensional transducer amplification", Sensors and actuators A 87 0001), 157-162 describes the technical details of the actuation of the actuator. 举例而言,五级弯张钹型致动器的厚度不到2mm,重量不到3g,且根据几何形状在1至IOOkHz之间共振。 For example, five flextensional Cymbal actuator is less than the thickness of 2mm, weighs less than 3g, and according to the geometry of the resonance between 1 IOOkHz. 由于薄型钹型设计, 该压电材料的高频率径向运动通过覆盖腔转化为低频率(约20-50kHz)位移运动。 Since the thin Cymbal design, high frequency radial movement of the piezoelectric material into the cavity covered by a low frequency (about 20-50kHz) displacement motions. 美国专利号为5,729,077 (Newnham等人)描述了钹型致动器的实例,该专利以引用的方式并入本文。 U.S. Patent No. 5,729,077 (Newnham et al.) Describes an example of a Cymbal actuator, which patent is incorporated by reference herein. 尽管附图所示的所述端盖为圆形,但该端盖并不仅限于一种形状或设计。 Although the end cap shown in the drawings are circular, but the cap is not limited to one shape or design. 例如,Smith NB等人在“用于改进超声经皮胰岛素给药的矩形钹型阵列”,J. Acoust. Soc. Am.,第122 卷,第4期(2007年10月)中公开了矩形钹型端盖设计。 For example, Smith NB et al., "Rectangular Cymbal for improving the ultrasound array transdermal administration of insulin", J. Acoust. Soc. Am., Vol. 122, No. 4 (for October 2007) discloses a rectangular cymbal cover design. 钹型致动器利用压电材料压电电荷系数d33 (施加到方向3的每单位场的方向3感应应力)和d31 (施加到方向3的每单位场的方向1感应应力)收缩的组合膨胀的优势,连同端盖612的弯张位移,该钹型致动器如图15所述。 Cymbal actuator using a piezoelectric material of the piezoelectric charge coefficient D33 (per unit applied field direction 3 induced stresses. 3) and D31 (direction per unit applied field induced stresses 1 3) a combination of expansion of contraction advantages, along with the flextensional displacement of the endcaps 612, the cymbal actuator 15 shown in FIG. 端盖612的设计允许对有助于所需方向的应力作出纵向和横向响应,从而根据公式deff = d33+(-A*d31)产生有效的压电电荷常数(deff)。 End cap 612 is designed to allow the longitudinal and transverse responses to contribute to stress in a desired direction, so that according to the formula deff = d33 + - produce an effective piezoelectric charge constant (deff) (A * d31). 由于d31为负数,且端盖612弯曲时放大系数(A)可高达100,只与压电材料相比,该钹型致动器产生的位移增加较为明显。 Since d31 is negative, and the amplification factor (A) when the end cap 612 is bent up to 100, compared with only the piezoelectric material, the displacement of the Cymbal actuator generates obvious increases. 端盖612可由各种材料制成,例如黄铜、钢、钛或KOVAR™,K0VAR™是与硼硅玻璃的热膨胀兼容的镍钴铁合金,硼硅玻璃允许在一定温度范围、优化性能和应用条件下进行直接机械连接。 End cap 612 may be made of various materials, such as brass, steel, titanium or KOVAR ™, K0VAR ™ is compatible with the thermal expansion of borosilicate glass, nickel-cobalt-iron alloy, borosilicate glass allows a certain temperature range, to optimize the performance and application conditions under a direct mechanical connection. 端盖612还提供额外机械稳定性,从而确保钹型致动器的长期使用寿命。 Endcaps 612 also provide additional mechanical stability, ensuring long life Cymbal actuator.

[0107] 钹型致动器610驱动穿透件513。 [0107] Cymbal actuator 610 drives the penetrating member 513. 钹型致动器610由交变电流启动时,相对电流频率正弦振动。 When Cymbal actuator 610 is activated by alternating current, the relative current frequency of the sinusoidal vibration. 由于端盖61¾固定在本体518的内侧壁上,钹型致动器610启动时,端盖612b相对沿平行于该医疗器械假设长轴方向的本体移动。 Since the cap fixed on the inner wall of 61¾ body 518, the Cymbal actuator 610 to start, end cap 612b relative to a direction parallel to the longitudinal direction of the medical device body is moved hypothesis. 此外,压电材料514在启动过程中压缩和膨胀(部分原因是端盖612设计引起的放大)时,穿透件513的位移相对压电材料514引起的位移放大。 Further, the piezoelectric material 514 during start compression and expansion (in part because of the end cap 612 is designed to cause amplification), the penetrating member 513 relative displacement of the displacement of the piezoelectric material 514 caused by the amplification. 例如,压电材料514单独只可位移约1-2微米,但连接端盖612后, 整个钹型致动器610可产生约lkM2251b-f)的力和约80-100微米的位移。 For example, the piezoelectric material 514 alone may only displacement of about 1-2 microns, but the connector cover 612, the entire Cymbal actuator 610 may produce about lkM2251b-f) a force of about 80-100 microns displacement. 该运动通过穿透件513进一步转化为100-300微米的放大纵向位移。 The movement 513 is further converted into an enlarged longitudinal displacement of 100-300 microns by penetrating member. 对于需要较高位移的情况,可在端盖至端盖之间堆叠若干钹型致动器610,以增加穿透件513的纵向总位移。 In the case of requiring higher displacement, may be stacked between the end caps to cover a plurality of Cymbal actuators 610, to increase the total longitudinal displacement of the penetrating member 513. 图16显示替代实施例600b,可拆卸穿透件毂525使该一次性穿透件具有可再次使用的主动运动把手。 Figure 16 shows an alternative embodiment 600b embodiments, the detachable penetrating member hub 525 such that the penetrating member having a disposable reusable active motion handle.

[0108] 在本发明的替代实施例中,形成与形成于该致动器本体内的通道连通的其他孔开口,例如Langevin致动器。 [0108] In an alternative embodiment of the present invention, is formed with apertures formed in the other of the actuator body of this passage opening, for example a Langevin actuator. 图17-图19特别针对所述替代实施例,应注意的是,为了清晰, 所述附图中未显示所述Langevin致动器把手118。 Figures 17 to 19 for the particular alternative embodiment, it should be noted that, for clarity, the figures of the Langevin actuator handle 118 is not shown.

[0109] 由于孔开口提供用以连接提供视觉、听觉或触觉反馈反应(例如使用任何知名的检测机构,例如但不限于电气装置、磁性装置、压力装置、电容装置、感应装置等)的装置指示成功穿透特点组织(例如硬膜外腔),必须在对所述装置产生最少不利的位置处形成所述开口。 [0109] Since the openings provided for connection to an indication means provide a visual, audible or tactile feedback response (e.g. using any known detection mechanism, such as but not limited to electrical, magnetic means, pressure means, capacitive means, sensing means, etc.) characteristics successfully penetrate tissue (e.g. epidural space), it must produce at least a difficult position the means forming the opening. 换句话说,由于所述致动器以高频率振动,沿所述致动器的各点均产生驻波限定的不同位移。 In other words, since the actuator vibration at high frequencies, each point along the actuator displacement standing waves are defined differently. 在图17中,位移图Gl代表驻波,所述驻波具有沿38kHz下操作的Langevin致动器长度的点处的纵向位移。 In FIG. 17, FIG Gl representative of the displacement of the standing wave, the standing wave having longitudinal displacements at points along the Langevin actuator operated 38kHz length. 由位移图Gl可见,所述驻波的特定位置存在具有近零位移的两个节点。 FIG Gl seen by the displacement of the position where the standing wave has two particular nodes near zero displacement. 因此,将Langevin致动器LT上的两个节点(“零节点” ZN)位置限定为沿所述Langevin致动器的特定长度。 Accordingly, the two nodes Langevin actuator ( "zero node" ZN) LT on the actuator position is defined as a specific length along the Langevin actuator. 在图17所示的特定设计中,驻波上的节点与零节点或具有Langevin致动器LT最小位移的位置一致。 In the particular design shown in Figure 17, the zero node or nodes on the standing wave having a Langevin actuator coincides with the position of minimum displacement actuator LT. 零节点在Langevin致动器LT上的位置位于相对远端面121的背部固定块近端面(未显示)。 Zero node located on the back surface of the fixed block opposite the proximal surface 121 of the distal end (not shown) at position Langevin actuator LT's. 线ZN限定其他零节点的物理位置,侧孔SP相对位移图Gl中驻波的第二零节点形成于Langevin致动器LT内时,应位于所述其他零节点处,最好位于中心。 Line ZN defines the physical location of other nodes to zero, the side port SP relative displacement of the second zero node of the standing wave in FIG Gl is formed at the time of the Langevin actuator LT actuator, a zero should be located at other nodes, preferably in the center. 在图17所示的情况下,侧孔SP形成于Langevin致动器LT的电极臂110处,然而,孔开口并不一定仅限于此。 In the case shown in FIG. 17, the side port SP is formed at the horn 110 Langevin actuator LT, however, the openings are not necessarily limited thereto. 孔开口可放置在沿致动器的任何地方,但优选零节点位置。 Openings may be placed anywhere along an actuator but a zero node location is preferred.

[0110] 在一个更优选实施例中,图17a描述穿透件毂525零节点ZN的侧孔SP位置。 [0110] In a more preferred embodiment, FIG. 17a penetrating member hub 525 is described zero node ZN of the side port SP location. 在本实施例中,设计长度包括达到空心针130零节点ZN的针身长度和致动器长度,还包括穿透件毂525的长度。 In the present embodiment, the design length includes a needle body reaches a length and actuator length actuator zero node ZN of the hollow needle 130, further comprising a length of penetrating member hub 525. 侧孔SP可放置在沿空心针130的任何地方,但优选穿透件毂525的零节点位置。 Side port SP can be placed anywhere along hollow needle 130 but preferably zero node location of the penetrating member hub 525.

[0111] 在图18a中,孔开口位于沿电极臂110的零节点位置中心时,以侧孔SP显示本发明的通常的侧孔配置700。 When [0111] In FIG. 18a, the aperture opening is located along the horn zero node location center 110, the display of the present invention generally lateral bore 700 is disposed to the side hole SP. 零节点处还形成支撑翼111,用以协助临床医师握住和稳定所述器械。 At zero node further support wing 111 is formed to assist the clinician holding and stabilizing the device.

[0112] 在如图18b所示的本发明第七实施例中,第一侧孔配置700a具有让液体、气体或其他物质通过的通道,且包括连续通路,该连续通路通过孔1¾经由近端开口IM通过远端开口(未显示),延伸穿过空心针130,在开口空心针的远端130a终止。 [0112] In the seventh embodiment of the present invention shown in FIG. 18b, 700a having a first side holes arranged so that a liquid, gas or other substance through the passage, and includes a continuous path, said continuous path through the proximal end through the hole 1¾ IM opening through the distal opening (not shown) extending through the hollow needle 130, terminating at a distal end opening of the hollow needle 130a. 在所述第七实施例中,该通道与沿孔1¾位置处的侧孔SP连通。 In the seventh embodiment, the communicating passage along the side port SP at a location 1¾ hole. 侧孔SP最好位于沿该致动器的位置,形成第一侧孔配置700a,启动所述器械振动后,第一侧孔配置700a作为零节点。 Preferably located along the side port SP of the actuator position, a first side hole configuration 700a is formed, after activating the vibration device, a first side holes 700a arranged as zero node.

[0113] 或者,如图18c的本发明第八实施例所示,第二侧孔配置700b具有让液体、气体或其他物质通过的通道,且包括位于空心针130穿透件毂525上的连续通路。 [0113] Alternatively, the eighth embodiment of the present invention is shown in Figure 18c, the second side holes 700b having a configuration allows a liquid, gas or other substance through the channel, and comprises a continuous hollow needle 130 penetrating member hub on 525 path. 在所述第八实施例中,所述通道与沿穿透件毂525位置处的侧孔SP连通。 In the eighth embodiment, the side port SP at the penetrating member along the hub passage 525 communicating position. 侧孔SP最好位于沿整个长度(致动器和穿透件)的位置,形成第二侧孔配置700b,启动所述器械振动后,第二侧孔配置700b作为零节点。 Preferably the side port SP located at a position along the entire length (actuator and penetrating member) forming a second side hole 700b configured, after starting the vibrating instrument, the second side holes 700b arranged as a zero node. 在位于所述致动器上的第二侧孔SP内,指示器,例如发光二极管1026, 可连接电子装置,以便显示视觉阻力损失。 In the second side port SP located on the actuator of the actuator, indicator, such as light emitting diode 1026 can be connected to the electronic device to display a visual loss of resistance.

[0114] 或者,如图18d的本发明第八实施例所示,第二侧孔SP配置700c具有让液体、气体或其他物质通过的小孔126a,小孔126a位于往返于空心针130的零节点ZN处。 [0114] Alternatively, the present invention is shown in an eighth embodiment 18d illustrated embodiment, a second side port SP configuration 700c has let liquid, gas or other material through the apertures 126a, 126a positioned aperture 130 of the hollow needle and from zero ZN at the node.

[0115] 在如图19所示的本发明第九实施例中,提供一种减力反馈工具800。 [0115] In a ninth embodiment of the present invention shown in FIG. 19, there is provided a reduced force feedback tool 800. 仅举例而言, 工具800包括通过传统低阻力注射针PA3提供触觉反馈响应的工具,传统低阻力注射针PA3 具有带柱塞或气囊(例如弹性体装置)或形成压力以检测或测量压力变化的任何其他装置的偏置元件11。 By way of example only, the tool 800 includes a tool providing tactile feedback response via a conventional needle PA3 low resistance, the conventional injection needle PA3 having a low resistance with a plunger or balloon (e.g., elastomer device) or a pressure to detect or measure pressure changes any other means of biasing element 11. 该器械(仅举例而言)鲁尔圆锥接头、外螺纹/内螺纹接头、螺纹接头耦合开口位置,最好是位于(最好位于中心)零节点位置的侧孔SP。 The instrument (for example only) luer taper, the male screw / female joint, threaded joint coupled to the opening position, is preferably located in the side port SP (preferably in the center) zero node location. 工具800还包括与致动器700连通的指示器,例如但不限于听觉指示器、触觉指示器或视觉指示器(例如放气、光学等)。 Tool 800 also comprises an actuator 700 and an indicator in communication, such as but not limited to, an audible indicator, tactile indicator, or a visual indicator (e.g. deflation, optical, etc.).

[0116] 在如图19a所示的本发明最优选实施例中,减力反馈工具800位于穿透件毂525 零节点ZN处的空心针130上。 [0116] In a most preferred embodiment of the invention shown in Figure 19a, the feedback force reduction tool 800 is located on the penetrating member hub 130 525 hollow needle at zero node ZN.

[0117] 在图19b所述的另一实施例中,包含小型泵送机构的可能性压力传感器反馈系统1020配备计量移除流体量的压力或流量传感器和安装在底部IOM上的容器1021。 [0117] In another embodiment according to FIG. 19b, the possibility of the pressure sensor feedback system 1020 containing a small pumping mechanism equipped with a metered amount of a fluid to remove the pressure or flow sensor and is mounted on the bottom of the container 1021 the IOM. 泵充满盐水,并通过经由连接配件1023的挠性管1022连接该穿透件的侧孔SP。 Pump filled with saline, and is connected via the side port SP of the penetrating member is connected via a flexible tube fitting of 10,221,023. 检测到无阻力(LOR)时,电子控制系统将关闭位于该致动器侧孔SP上的开关和指示器,例如发光二极管(LED)(未显示),并打开阻力损失指示。 When no resistance is detected (the LOR), the electronic control system would close the actuator switches and indicators on the actuator side of the hole the SP, such as light emitting diodes (the LED) (not shown), and loss of resistance to opening indication. 此时,该电子控制系统会关闭该致动器,因此,向前运动停止。 At this time, the electronic control system will close the actuator, and therefore, the forward movement is stopped. 在其他实施例中,除视觉信号外,听觉信号“嘟嘟声”可并入所述泵系统。 In other embodiments, in addition to a visual signal, an audible signal "beep" may be incorporated into the pump system.

17[0118] 仅举例而言,以下是使用本发明的示例性方法,由此,临床医师使用本发明进行硬膜外手术。 17 [0118] By way of example only, the following is an exemplary method of the invention, whereby a clinician using epidural surgery according to the present invention. 进行硬膜外手术时,临床医师首先将注射器PA3充满流体,例如盐溶液或空气。 When the epidural procedure, the clinician first syringe PA3 filled with a fluid, such as saline solution or air. 然后,临床医师将注射器的前部9插入致动器700b的侧孔SP。 Then, the clinician of the front portion of the syringe 9 is inserted actuators SP 700b of the side hole. 电启动该致动器后,临床医师用第一把手握住致动器700b,同时使空心针的远端130a压住患者背部。 After starting the electric actuator, the clinician holds actuator with handle 700B, while the distal end of the hollow needle 130a pressed against the patient's back. 临床医师继续提供向前动力,同时还提供相对偏置元件11的偏置力,并推进空心针130。 Clinician continues to provide forward momentum, while also providing a biasing force opposing the biasing element 11, advancing hollow needle 130 and. 在连续向前动力的作用下,该空心针穿刺棘上韧带、棘间韧带和黄韧带(例如,见图7)。 In the continuous forward force acting on the hollow needle ligament, interspinous ligament and ligamentum flavum (e.g., see FIG. 7). 刺穿黄韧带后,针的远端130a进入硬膜外腔,此时,偏置元件11至远端130a开口出现压力下降。 After puncturing the ligamentum flavum, the distal end 130a of the needle into the epidural space, this time, the biasing element 11 to the distal end opening 130a appears pressure drop. 压力下降使溶液从远端130a开口喷出,偏置元件11的持续偏置与盐水体积损耗一起造成相对临床医师拇指的低阻力(LOR)和偏置元件11的明显可确认运动。 The solution was pressure drop is ejected from the distal end opening 130a, resulting in significantly low resistance to relative motion confirmed clinician thumb (the LOR) and a biasing member biasing element 11 together with the brine volume loss sustained bias 11. 所述偏置元件因阻力缺乏移动时, 临床医师迅速确认已成功到达硬膜外腔,并迅速停止该致动器的向前动力。 The biasing element moves due to the lack of resistance when the clinician quickly identify the epidural space has been successfully reached and quickly stops forward momentum of the actuator. 此外,由于该致动器的启动导致针130振动,临床医师不需要提供如此高的穿透力,并且可迅速反应,以便在所述针超过硬膜外腔前停下来。 Further, since the start of the actuator causes the vibration of the needle 130, the clinician does not need to provide such a high penetration force and can respond quickly to a stop prior to the epidural space over the needle.

[0119] 另外还应注意的是,在本发明的广泛范围之内,包括提供自动偏置的注射器或其他机构,使得进入(例如)硬膜外腔前,临床医师不需要对偏置元件11施加偏置力。 [0119] It should be further noted that within the broad scope of the present invention, comprising providing an automatic syringe or other biasing mechanism, such that entry (e.g.) before the epidural space, the clinician does not require the bias element 11 applying a biasing force. 特别地,针穿过棘上韧带、棘间韧带和黄韧带时,自动偏置力(例如,通过弹簧、弹性体或任何其他知名的偏置机构,例如但不限于美国专利公开案第2007/0142766号(Sundar等人)所述的偏置机构实施)维持相等的阻力。 In particular, the ligament through the needle, and when the spine ligament flavum, automatic biasing force (e.g., by a spring, an elastomer, or any other well-known biasing mechanism such as, but not limited to, U.S. Patent Publication No. 2007 / embodiment No. 0,142,766 (Sundar et al.) of the biasing mechanism) is maintained equal resistance. 进入硬膜外腔后,偏置力不再受到抵抗,可以各种方式向临床医师证明偏置力不再受到抵抗,但不限于偏置元件移动或通过任何知名的检测机构(例如但不限于电气装置、磁性装置、压力装置、电容装置、感应装置等)的任何其他视觉指示、听觉指示或触觉指示。 After entering the epidural space, the biasing force is no longer resisted by, may be demonstrated in various ways to the clinician biasing force is no longer resisted by, but not limited to moving or biasing element by any known detection mechanism (e.g., but not limited to, any other visual electrical devices, magnetic means, pressure means, capacitive means, sensing means, etc.) indication, an audible indication or a tactile indication. 例如,指示溶液阻力损失的压力信号自动切断驱动致动器(例如压电元件、音圈、螺线管等)的电源。 For example, the solution resistance loss of the pressure indicating signal is automatically cut off the power driven actuator (such as a piezoelectric element, a voice coil, solenoid, etc.).

[0120] 尽管反馈装置耦合侧孔SP,本发明并不仅限于反馈装置。 [0120] While feedback means coupled to the side hole SP, the present invention is not limited to feedback means. 任何器械均可耦合该致动器的孔位置,或最好侧孔SP位置,尽管所述器械仅仅是提供或清除液体、气体或其他物质的器械(例如传统注射器)。 Any instrument can be coupled to the hole position of the actuator or, preferably, the side port SP location, although the instrument or merely provide a clear liquid, gas, or other substances instrument (such as a conventional syringe).

[0121] 尽管本发明的上述实施例涉及一种具有振动穿透件并使用如前所述的Langevin 致动器、钹型致动器或APA进行致动的手持式医疗器械,本发明并不仅限于所述致动器组件。 [0121] Although the above embodiments of the present invention relates to a vibrating penetrating member and used as previously described Langevin actuator, Cymbal actuator, or APA for actuation of the handheld medical device, the present invention is not limited to the actuator assembly. 通常,包括致动器组件且还包括耦合压电材料的固定块的任何类型的电机或音圈电机或螺线管或任何其他平移运动装置均属于本发明的精神和范围。 Typically, comprising an actuator assembly and further comprises a fixed block of any type of motor or a piezoelectric material coupled to the voice coil motor or a solenoid, or any other translational motion device are within the spirit and scope of the invention. 此外,如果所述致动器组件包括耦合至压电材料的固定块,具有几何形状的所述致动器组件也属于本发明的精神和范围,所述致动器组件在致动后放大朝某个方向的运动,使其超过所述压电材料的最大应力。 Further, if the said actuator assembly coupled to the fixing block comprises a piezoelectric material, having a geometry actuator assembly also within the spirit and scope of the invention, the actuator assembly toward an enlarged upon actuation move in one direction, so that it exceeds the maximum stress of the piezoelectric material.

[0122] 图20a描述本发明的替代实施例900,替代实施例900使用音圈作为驱动致动器, 而非压电元件。 [0122] FIG 20a is described an alternative embodiment 900 of the present embodiment of the invention, an alternative embodiment 900 uses a voice coil actuator as a drive, rather than piezoelectric element. 音圈致动器(也称为“音圈电机”)产生低频率往复运动。 Voice coil actuator (also referred to as a "voice coil motor") produce a low frequency reciprocating motion. 音圈的带宽约为10-60HZ,位移达10mm,取决于施加的交流电压。 The coil bandwidth of approximately 10-60 Hz, the displacement of 10mm, depending on the applied AC voltage. 特别地,电感线圈902施加交变电流时,结果为电感线圈902的电流方向与磁性件904的磁场矢量之间的叉积函数限定方向的洛伦兹力。 In particular, the inductor 902 is applied to the alternating current, the results of the cross product is defined as a function of the direction of the magnetic field vector between the current direction and the magnetic member 902 of the inductor 904 Lorentz force. 所述力使磁性体904相对线圈支管906做往复运动,本体910将线圈支管906固定就位。 The force of the coil 904 relative to the manifold 906 reciprocates the magnetic body, the coil body 910 manifold 906 is secured in place. 由于固定在驱动管912上的磁性件904,驱动管912将所述运动传递给延伸件914,延伸件914反过来将运动传递给穿透件20。 Since the magnetic member 912 fixed to the drive tube 904, drive tube 912 extending to the motion transmitting member 914, extension member 914 in turn transmits the motion to the penetrating member 20.

[0123] 第一连接点916a将线圈支管906的远端固定到本体910上;第二连接点916b将线圈支管906的近端固定到本体910上。 The distal end of [0123] a first junction 916a of the coil support tube 906 is fixed to the body 910; and a second connection point of proximal end 916b of the coil support tube 906 is fixed to the body 910. 电感线圈可由不同配置组成,包括但不限于由单线形成的几层、由圆形或其他几何形状的不同线构成的几层。 The inductor may be composed of different configurations, including but not limited to several layers formed by a single wire, constituted by a circular or other geometric shapes of different wire layers. 在如图20a所示的电感线圈第一实施例中,通过以类旋转和螺旋方式沿径向(所述线圈支管周围)缠绕线形成第一层导电线,整转形成一个紧挨前一个线匝且位于所述线圈支管第一纵向下方的线匝。 FIG inductor 20a shown in the first embodiment, by rotating type and a spiral manner in the radial direction (around the branch pipe coil) wound wire forming a first layer of conductive lines, a complete revolution is formed immediately before a line located turns of the coil and a first branch pipe below the longitudinal turns. 预定匝数后, 通过在第一层最后线匝上重叠第二线层的第一线匝,同时沿与第一层相同的径向继续缠绕线在第一层上形成额外层,从而形成具有至少与第一层匝数相同的第二螺旋线,每个线匝紧挨前一个线匝,且在与第一层的形成方向相反的纵向。 After a predetermined number of turns, a first turn overlapped by a second wire layer on the last turn of the first layer, while along the same radial line forming the first winding layer continues to additional layers on the first layer to form at least and a second helix same number of turns of the first layer, the turns of each line immediately before a turn, and in the opposite direction of the first layer is formed longitudinally. 在本实施例中,可通过在上一层的最后线匝上重叠每个额外线层的第一线匝,同时沿与前一层相同的径向继续缠绕线而增加额外层,从而形成具有至少与上一层匝数相同的额外螺旋线,每个线匝紧挨前一个线匝,且在与上一层的形成方向相反的纵向。 In the present embodiment, by overlapping a first turn of each additional wiring layer on the upper layer of the final turn, while the additional layer in the same radial layer before continuing with wound wire, thereby forming a at least one layer of the same number of turns of the additional spiral, the turns of each line immediately before a turn, and the longitudinal direction is formed on the opposite layer.

[0124] 图20b显示替代音圈实施例900b。 [0124] FIG 20b show an alternative voice coil embodiment 900b. 特别地,在所述替代实施例中,切换磁性件904 与电感线圈902的位置。 In particular, in the alternate embodiment, the switching position of the magnetic member 904 and the inductor 902. 换句话说,所述电感线圈缠绕并连接驱动管912,磁性件904沿线圈支管906的外半径设置。 In other words, the inductor is wound and connected to the drive tube 912, magnetic coil 904 along the outside radius of the manifold 906 is provided.

[0125] 电气信号应用于导电连接位置918和920,且是形成交变方向洛伦兹力的原因,所述洛伦兹力使电感线圈902和延伸件914沿所述器械纵轴往复运动。 [0125] an electrical signal is applied to the conductive connecting positions 918 and 920, and is the cause of an alternating direction of the Lorentz force, the Lorentz force 902 and inductor member 914 extending along the longitudinal axis of the instrument to reciprocate. 所述电感线圈直接接触本实施例的所述驱动管。 Direct contact of the inductor coil of the present embodiment, the drive tube.

[0126] 图20c描述本发明另一实施例,该实施例使用音圈致动机构,且具有与图20a和20b中所用实施例不同的配置。 [0126] Figure 20c is described another embodiment of the present invention, this embodiment uses a voice coil actuator means, and having different configurations and FIGS. 20a and 20b used in the embodiment. 例如,在本替代实施例中,用双线圈致动机构代替音圈致动机构,所述代替的结果是,所述音圈的磁性件904替换为第二电感线圈922。 For example, in an alternative embodiment of the present embodiment, the double-coil actuator mechanism actuating mechanism in place of a voice coil, instead of the result, the magnetic member 904 is a second alternative of the voice coil inductor 922. 换句话说,第二电感线圈922缠绕并连接驱动管912,正如第一优选实施例,第一电感线圈902沿线圈支管906的外半径设置。 In other words, the second inductor coil 922 is wound and connected to the drive tube 912, as with the first preferred embodiment, the outer radius of the first inductor coil 902 along the branch pipe 906 is provided. 在图20c配置的第一实施例中,内线圈922传导直流电流,外线圈传导交变电流。 In the first embodiment in the configuration of FIG. 20c, the inner coil 922 conducting direct current, alternating current conducting outer coil. 在一个替代实施例中,所述内线圈传导交变电流,所述外线圈传导直流电流,在其他实施例中,所述内线圈和所述外线圈均传导交变电流。 In an alternative embodiment, the inner coil is conducting alternating current, the outer coil is conducting direct current, in other embodiments, the inner coil and the outer coil are conducting alternating current.

[0127] 在所有所述音圈致动器配置中,弹簧可用于限制和控制穿透件20的某些动态方面。 [0127] In all of the voice coil actuator configurations, the spring may be used to limit and control certain dynamic aspects of the penetrating member 20. 图20d描述使用弹簧的第十实施例音圈致动器机构的另一种变型,即使用电磁致动器1000的医疗工具。 FIG. 20d describes the use of a spring to a tenth embodiment of the voice coil actuator mechanism of another variant, i.e. the use of the electromagnetic actuator 1000 medical tools. 正如使用线圈的其他音圈实施例,由电磁线圈1002内部产生的时变磁场引起基本驱动原理,电磁线圈1002作用于一组很强的永久磁铁。 As another embodiment of a voice coil using the coil, is generated by the internal magnetic field caused by electromagnetic coil 1002 basic driving principle, the solenoid 1002 to act on a set of very strong permanent magnets. 磁铁1004和整个穿透件20组件通过电磁线圈1002来回振荡。 Magnets 1004 and the entire penetrating member 20 assembly 1002 by a solenoid oscillating back and forth. 弹簧1014(例如图20d所示的弹簧)在各个周期吸收和释放能量,从而放大穿透件20处可见的振动。 Spring 1014 (e.g., as shown in FIG spring 20d) in each cycle of vibration absorption and release energy, thereby amplifying the penetrating member 20 is visible. 可通过磁铁选择、螺线管内的线圈匝数、 轴质量和弹簧刚度优化所述器械的共振特性。 By magnet selection, number of coil turns in the solenoid, mass of the shaft and the resonance characteristics of the spring stiffness optimizing instrument.

[0128] 从以上描述可见,应了解,本发明提供优于传统医疗器械的明显益处。 [0128] From the above description, it should be appreciated that the present invention provides significant benefits over conventional medical devices. 上述致动装置的配置,例如包括Langevin致动器、钹型致动器或APA的实施例,通过使所述尖锐穿透件或针达到此类频率(使骨活检、硬膜外导管插入或血管注射等手术中穿透组织所需的力减少)使医疗器械中适于使用压电致动件。 Said actuating means arranged, for example, comprising a Langevin actuator, Cymbal actuator, or embodiments APA by the sharp needle or penetrating member reaches such frequency (bone biopsy, epidural catheterization or vascular surgery, injection or the like to reduce the force required to penetrate tissue) is adapted to cause the medical device using a piezoelectric actuator element. 电气耦合反馈系统促发的电气信号控制可提供进行手术的高振荡率致动容量、穿透深度控制、电源切断(比人的反应更快)和低牵引力。 Electrically coupled feedback system may trigger a control signal to provide an electrical high oscillation rate actuation of surgical capacity, penetration depth control, power-off (faster response than human) and low traction. 仅举例而言,图21描述一种电源切断配置。 By way of example only, FIG. 21 describes a power cutoff configuration. 压力传感器PT监控穿透件20或通过本发明与组织连通的流体的压力。 PT pressure sensor monitoring the pressure member 20 penetrating fluid or tissue of the present invention the communication. 尽管穿透件20穿透组织,压力传感器PT检测的压力较高,且开关S 通常关闭。 While the penetrating member 20 penetrates the tissue, the higher the pressure detecting sensor PT, and the switch S is normally closed. 一旦压力下降(指示穿过最后一层组织),压力传感器PT信号就会打开开关S, 从而切断所述医疗工具的电源。 Once the pressure drops (indicating the last one through the tissue), the pressure transducer PT signal opens the switch S, thereby cutting off the power supply of the medical instrument. 此外,视觉指示器、听觉指示器或触觉指示器立即激活,警告操作员穿透件20完全穿过,且电源切断。 In addition, a visual indicator, an audible indicator or a tactile indicator immediately activates warning the operator to penetrate completely through the member 20, and the power cut off. 在本发明的广泛范围内,包含各种电源切断配置,包括固态切换和/或数字控制。 Within the broad scope of the present invention, comprise various power-off configurations, including solid state switching and / or digital control.

[0129] 另一种电源切断执行装置检测上文所述偏置元件11的向前运动。 [0129] Another power source 11 is cut and the forward motion of the biasing element detecting apparatus described above. 特别地,一旦穿透件20穿过最后一层组织,偏置元件11的压力释放,传感器检测偏置元件11在本体10内的增量运动,所述传感器立即断开开关S,从而切断本发明的电源。 In particular, once the penetrating member 20 passes through the final layer of tissue, the pressure of the biasing member 11 is released, the biasing element 11 increments the sensor detects movement within the body 10, the sensor immediately turns off the switch S, thereby cutting off the present power invention.

[0130] 此外,由于提取组织后,骨活检中有必要从活体内收回所述穿透件,电子装置的反馈控制使所述器械能以同时减小力的方式振动。 [0130] Further, since the extraction of the tissue, bone biopsy is necessary to withdraw from the living body of the penetrating member, the feedback control means causes the electronic device in a manner capable of vibration while reducing force.

[0131] 既然显示并详细描述了本发明的示例性实施例,所作的各种修改和改进对所属领域的技术人员来说显而易见。 [0131] Since the details shown and described with exemplary embodiments of the present invention, various modifications and improvements of ordinary skill in the art made apparent. 尽管上述实施例可能涉及穿透作为示例性生物组织的皮肤、 骨质、静脉和韧带,本发明无疑能确保通常要穿透身体的其他组织的类似效果。 Although the above embodiments may be directed to penetrate biological tissue as an exemplary skin, bone, veins and ligaments, the present invention can undoubtedly ensure similar effects usually penetrate other tissues of the body. 例如,有多种其他工具(如中心静脉导管导入器、带相关针头的腹腔镜仪器、腔引流导管套件和新生儿柳叶刀)和多种手术(诸如胰岛素给药和经皮葡萄糖测试),仅以此为例,其中包括声波或超声波驱动尖锐件的本文公开实施例可用于以最小着色力精确穿破或穿刺组织。 For example, a variety of other tools (e.g., central venous catheter introducer, laparoscopic instruments with associated needle, the cavity drainage catheter kits, and neonatal lancets) and a plurality of surgery (such as insulin administration and percutaneous glucose testing), only as an example, the disclosed embodiment includes a sonic or ultrasonic driving sharps embodiments described herein may be used to puncture or minimal coloring power exact puncturing tissue. 相应地,本发明的精神和范围只可由所附权利要求进行广泛和限制性解释,不由上述说明书进行解释。 Accordingly, the spirit and scope of the invention being limited only by the appended claims and limiting extensive interpretation, not by the above description will be explained.

[0132] 参考标签 [0132] Reference tab

[0133] A静态针穿刺力曲线 [0133] A Static needle force curve

[0134] B振动针穿刺力曲线 [0134] B vibrating needle force curve

[0135] Gl位移图 [0135] Gl displacement FIG.

[0136] LT Langevin致动器(也称为Langevin传感器) [0136] LT Langevin actuator (also known as Langevin transducer)

[0137] PAl传统活检针 [0137] PAl conventional biopsy needle

[0138] PA2传统硬膜外针 [0138] PA2 conventional epidural needle

[0139] PA3传统注射器 [0139] PA3 conventional syringe

[0140] PT压力传感器 [0140] PT pressure sensor

[0141] S 开关 [0141] S switch

[0142] SP 侧孔 [0142] SP side hole

[0143] ZN零节点 [0143] ZN Zero node

[0144] 1 套管 [0144] 1 bushing

[0145] 1,套管远端 [0145] 1, the distal end of the cannula

[0146] 2管心针 [0146] 2 stylet

[0147] 3 远端尖 [0147] distal tip 3

[0148] 4管心针尖角面 [0148] 4 center tip surface angle

[0149] 5 Tuohy 针 [0149] 5 Tuohy needle

[0150] 6 iTuohy 弯曲尖 [0150] 6 iTuohy curved tip

[0151] 7 尖开口 [0151] 7 tip opening

[0152] 9 前部 [0152] 9 the front portion

[0153] 10 管状体 [0153] 10 of the tubular body

[0154] 11偏置元件 [0154] 11 biasing element

[0155] 12 柱塞[0156] 14 内管心针[0157] 15 外套管针管[0158] 16 APA针[0159] 16b 替代实施例[0160] 20 穿透件[0161] 100 Langevin致动器[0162] 110 电极臂[0163] 111 支撑翼[0164] 112 背部固定块[0165] 114 压电元件[0166] 114b 电导体[0167] 115 灭菌套[0168] 116 螺栓[0169] 117 电池和逆变器室[0170] 118 把手[0171] 120 密封件[0172] 121 远端面[0173] 122 远端开口[0174] 123 鲁尔锥形头[0175] 124 近端开口[0176] 126 孔[0177] 126a 短孔[0178] 128 连接配件[0179] 129 导管[0180] 130 空心针[0181] 130a 空心针远端[0182] 130b 空心针近端[0183] 132 柱塞把手[0184] 134 柱塞轴[0185] 134a 柱塞轴近端[0186] 134b 柱塞轴远端[0187] 136 柱塞密封[0188] 142 内管心针柄[0189] 144 内管心针轴[0190] 146 内管心针尖[0191] 148 套管针连接配件[0192] 150 外套管针体[0193] 152 远端套管针开口[0194] 154 远套管针尖0195] 200 穿透导入器0196] 202b 更优选实施例0197] 202c 最优选实施 [0155] 12 plunger [0156] the inner stylet 14 [0157] 15 outer trocar tube [0158] 16 APA needle [0159] 16b alternative embodiment [0160] 20 penetrator [0161] 100 Langevin actuator of [ 0162] horn 110 [0163] 111 support wing [0164] 112 rear mass [0165] The piezoelectric element 114 [0166] 114b electrical conductors [0167] 115 sets sterilization [0168] bolts 116 [0169] 117 cells and inverse variable chamber [0170] 118 of the handle [0171] 120 seal [0172] 121 distal end surface [0173] 122 distal opening [0174] luer conical head 123 [0175] 124 proximal opening [0176] 126 hole [ 0177] 126a short hole [0178] 128 connection fitting [0179] conduit 129 [0180] 130 of the hollow needle [0181] 130a of the hollow needle distal end [0182] 130b of the hollow needle proximal end [0183] 132 of the plunger handle [0184] column 134 plug shaft [0185] 134a of the plunger shaft proximal end [0186] 134b of the plunger shaft distal end [0187] 136 seal the plunger [0188] 142 inner stylet handle [0189] the inner stylet shaft 144 [0190] 146 stylet tip [0191] connection fitting 148 of the trocar [0192] outer trocar body 150 [0193] 152 distal trocar opening [0194] 154 the cannula distal tip 0195] 200 penetrating introducer 0196] 202b more preferably 0197] 202c embodiment most preferred embodiment 例0198] 201 配套导入器0199] 202 导管插入器0200] 300 骨活检器械0201] 400 高级骨活检器械0202] 500 APA注射器0203] 500b 替代实施例0204] 510 放大型压电致动奢0205] 512 框架0206] 512a 框架近端0207] 512b 框架远端0208] 513 穿透件0209] 513a 穿透件近端0210] 513b 穿透件远端尖0211] 514 压电材料0212] 516 APA连接点0213] 518 把手0214] 521 把手远端开口0215] 524 把手近端开口0216] 525 穿透件毂0217] 526 APA孔0218] 600 钹型注射器0219] 600b 替代实施例0220] 610 钹型致动器0221] 612 立而盖0222] 612a 近端端盖0223] 612b 远端端盖0224] 626 钹型孔0225] 616 钹型连接点0226] 700 一般侧孔配置0227] 700a 第一侧孔配置0228] 700b 第二侧孔配置0229] 800 减力反馈工具0230] 900 使用音圈致动器白0231] 900b 替代音圈实施例0232] 902 电感线圈0233] 904 磁性件[0234] 906 线圈支管 Example 0198] 201 supporting introducer 0199] 202 is inserted into the catheter 0200] 300 bone biopsy instrument 0201] 400 advanced bone biopsy instrument 0202] 500 APA syringe 0203] 500b alternate embodiment 0204] amplified piezoelectric actuator 510 luxury 0205] 512 0206] 512a frame proximal frame 0207] 512b distal frame 0208] 513 penetrating member 0209] 513a penetrating the proximal end 0210] 513b penetrating distal tip member 0211] 514 of the piezoelectric material 0212] 516 APA junction 0213] 518 handle 0214] 521 distal end of the handle opening 0215] proximal end 524 of the handle opening 0216] 525 penetrating member hub 0217] 526 APA holes 0218] 600 cymbal syringe 0219] 600b alternate embodiment 0220] cymbal actuator 610 embodiment 0221] stand 612 and the cover 0222] 612a proximal end cap 0223] 612b distal end cap 0224] 0225] 0226] 700 ships side hole 616 cymbal attachment point 626 cymbal bore arranged 0227] 700a disposed a first side holes 0228] 700b of Example 0232] side holes 902 arranged two inductor 0229] 800 force feedback tool Save 0230] using a voice coil actuator 900 white 0231] 900b alternate embodiment coil 0233] The magnetic member 904 [0234] 906 coil manifold

[0235] 910 本体 [0235] 910 body

[0236] 912 驱动管 [0236] 912 drive tube

[0237] 914 延伸件 [0237] 914 extending member

[0238] 916a第一连接点 [0238] 916a first connection point

[0239] 916b第二连接点 [0239] 916b second connecting point

[0240] 918第一导电连接位置 [0240] a first conductive connection position 918

[0241] 920第二导电连接位置 [0241] 920 a second conductive connection position

[0242] 922 第二电感线圈 [0242] The second inductor 922

[0243] 1000使用电磁致动器的医疗工具 [0243] 1000 using electromagnetic actuator medical instrument

[0244] 1002 电磁线圈 [0244] solenoid 1002

[0245] 1004 磁铁 [0245] 1004 magnets

[0246] 1014 弹簧 [0246] Spring 1014

[0247] 1020 压力反馈系统 [0247] Pressure feedback system 1020

[0248] 1021具有集成泵的容器 [0248] 1021 having an integrated pump container

[0249] 1022 挠性管 [0249] The flexible tube 1022

[0250] 1023 连接配件 [0250] connection fitting 1023

[0251] 1024 底部 [0251] 1024 at the bottom

[0252] 1025 通断开关 [0252] 1025-off switch

[0253] 1026发光二极管 [0253] LED 1026

Claims (33)

  1. 1. 一种用于穿透活体组织的医疗器械,所述器械包括:穿透件,所述穿透件往复离开和进入所述医疗器械,以减小穿透活体组织所需的力; 驱动致动器,所述驱动致动器耦合所述穿透件,以便在通电时将电能转换为往复运动;电源切断装置,所述电源切断装置用于在所述穿透件穿过活体组织后使所述医疗器械断电。 CLAIMS 1. A medical device for penetrating living tissue, the instrument comprising: a penetrating member, said penetrating member and into the shuttle away from the medical device to reduce the force required to penetrate the living tissue; drive the actuator, said drive actuator is coupled to the penetrating member, when energized, to convert electrical energy into reciprocating motion; power-off means, means for cutting the power supply after said penetrating member through body tissue so that the medical device off.
  2. 2.根据权利要求1所述的医疗器械,其中所述驱动致动器包括:具有远端和耦合至所述远端的所述穿透件的致动器,所述致动器包括延伸至所述远端的第一通道,所述致动器还包括至少一个压电元件,所述至少一个压电元件用于在通电时将电能转换为振荡运动;所述致动器还包括第二通道,所述第二通道的第一端与所述第一通道连通,第二端位于所述致动器的外表面;所述至少一个压电元件通电时,所述致动器移动所述远端和所述穿透件,使其做振荡运动。 2. The medical instrument according to claim 1, wherein said driving actuator comprising: a distal end having a distal end and coupled to said penetrating member actuator, the actuator extending to include the distal end of the first passage, the actuator further comprises at least one piezoelectric element, said at least one piezoelectric element for converting electrical energy when energized oscillating movement; the actuator further comprises a second channel, a first end of the second passage communicating with the first passage, the second end of the outer surface of said actuator; said at least one piezoelectric element is energized, the actuator moves the distal end and said penetrating member so as to make an oscillating motion.
  3. 3.根据权利要求2所述的医疗器械,其中所述至少一个压电元件适合于以一定频率振动,以产生所述穿透件的正弦位移。 3. The medical instrument according to claim 2, wherein the at least one piezoelectric element adapted for vibrating at a frequency, to generate a sinusoidal displacement of the penetrating member.
  4. 4.根据权利要求2所述的医疗器械,其中所述第一通道延伸穿过所述穿透件,第三通道延伸穿过所述至少一个压电元件,所述第一通道与所述第三通道对准,其中所述致动器还包括具有第四通道的锚,所述第四通道沿所述锚的纵轴延伸穿过所述锚,所述第四通道与所述第一通道和所述第三通道对准,以形成穿过所述致动器的连续通道。 4. The medical instrument according to claim 2, wherein said first passageway extends through said penetrating member, said third passageway extending through the at least one piezoelectric element, said first and said second passage aligning three-channel, wherein said actuator further comprises an anchor having a fourth channel, said fourth channel extending along a longitudinal axis of the anchor through said anchor, said fourth channel and said first passage and the third channel are aligned to form a continuous channel through the actuator.
  5. 5.根据权利要求2所述的医疗器械,其中所述第一通道延伸穿过所述穿透件的一部分。 5. The medical instrument according to claim 2, wherein said first passageway extends through a portion of said penetrating member.
  6. 6.根据权利要求1所述的医疗器械,其中所述穿透件是皮下注射针、导管插入针、 Tuohy针、骨活检套管针、脊椎穿刺针、神经阻滞针、套管针入孔和介入放射针的其中之一。 6. The medical instrument according to claim 1, wherein the penetrating member is a hypodermic needle, a catheter insertion needle, a Tuohy needle, bone biopsy trocar, spinal needle, nerve block needle, trocar into the hole and interventional radiology pin one of them.
  7. 7.根据权利要求2所述的医疗器械,其中所述致动器为Langevin致动器。 7. The medical instrument according to claim 2, wherein said actuator is a Langevin actuator.
  8. 8.根据权利要求7所述的医疗器械,其中所述Langevin致动器的所述远端限定反节点ο 8. The medical instrument according to claim 7, wherein said Langevin actuator defines a distal end anti-node ο
  9. 9.根据权利要求1所述的医疗器械,其中所述致动器的外表面包括侧孔,所述侧孔用于向所述穿透件提供流体通道或提供所述穿透件内的导管通道。 9. The medical instrument according to claim 1, wherein an outer surface of said actuator comprises a side hole, said side hole for providing a fluid passage provided to said penetrating member or conduit within said penetrating member aisle.
  10. 10.根据权利要求2所述的医疗器械,其中与第一通道连通的所述第二通道从所述致动器的纵轴径向延伸,并置于限定零节点的位置中心。 10. The medical device according to claim 2, wherein said first passage communicating with a second passage extending radially from the longitudinal axis of the actuator, and placed in the center of defined zero position of the node.
  11. 11.根据权利要求1所述的医疗器械,还包括耦合至所述致动器内孔的含液注射器,所述含液注射器包括置于其中的可移动偏置元件,其中所述偏置元件与所述穿透件内的通道流体连通,所述穿透件穿过活体组织时,所述偏置元件提供指示器。 11. The medical device according to claim 1, further comprising a fluid-containing syringe coupled to the inner bore of the actuation of the actuator, said syringe containing a liquid disposed therein comprising a movable biasing member, wherein the biasing element a fluid channel within said penetrating member communication, the penetrating member passes through the living tissue when the biasing member providing an indicator.
  12. 12.根据权利要求1所述的医疗器械,还包括耦合至所述医疗器械的针连接配件内孔的含液注射器,所述含液注射器包括置于其中的可移动柱塞,其中所述柱塞与所述穿透件内的通道流体连通,所述穿透件穿过活体组织时,所述柱塞提供指示。 12. The medical device according to claim 1, further comprising a fluid-containing syringe coupled to a needle of the medical device connector fitting hole, the liquid-containing syringe comprising a plunger movably disposed therein, wherein said column plug within said fluid communication channel and penetrating member, said penetrating member passes through the living tissue when said plunger to provide an indication.
  13. 13.根据权利要求1所述的医疗器械,还包括与所述致动器通过接口连接的低阻力泵系统,所述低阻力泵系统包括视觉指示器,所述视觉指示器自动指示所述穿透件进入预定身体区。 13. The medical device according to claim 1, further comprising a low resistance to the actuator interfaces via a pump system, the pump system comprising a low resistance visual indicator, the visual indicator indicating that the automatic wear pieces into the body through a predetermined area.
  14. 14.根据权利要求13所述的医疗器械,其中所述视觉指示器包括LED。 14. The medical device according to claim 13, wherein the visual indicator comprises an LED.
  15. 15.根据权利要求12所述的医疗器械,其中所述柱塞提供所述穿透件穿过活体组织的视觉指示、听觉指示或触觉指示的其中之一。 15. The medical instrument of claim 12, wherein said plunger is provided through said penetrating body tissue visual indication member, wherein one of an audible indication or a tactile indication.
  16. 16.根据权利要求12所述的医疗器械,其中所述柱塞启动所述电源切断装置。 16. The medical instrument of claim 12, wherein said plunger activating the power shutdown device.
  17. 17.根据权利要求1所述的医疗器械,其中压力传感器检测所述穿透件的所述通道内的压力,并启动所述电源切断装置。 17. The medical device according to claim 1, wherein the pressure sensor detects the pressure of the penetrating member within the channel, and to activate the power-off device.
  18. 18.根据权利要求1所述的医疗器械,其中所述驱动致动器包括耦合至所述穿透件的音圈,通电时所述音圈将电能转换为振荡运动。 18. The medical device according to claim 1, wherein said driving actuator comprises a voice coil coupled to said penetrating member, said voice coil when energized convert electrical energy into oscillatory motion.
  19. 19.根据权利要求18所述的医疗器械,其中所述音圈包括缠绕永久磁铁和所述穿透件的线圈。 19. A medical device according to claim 18, wherein said coil comprises a permanent magnet and a coil wound around said penetrating member.
  20. 20.根据权利要求19所述的医疗器械,还包括位于所述线圈和所述永久磁铁相对侧的弹簧。 20. The medical device according to claim 19, further comprising a spring coil and the permanent magnet opposite side.
  21. 21.根据权利要求18所述的医疗器械,其中所述音圈包括缠绕线圈和所述穿透件的永久磁铁。 21. The medical device according to claim 18, wherein said coil comprises a permanent magnet and a coil wound around said penetrating member.
  22. 22.根据权利要求18所述的医疗器械,其中所述音圈包括缠绕所述穿透件的一对同心线圈。 22. The medical device according to claim 18, wherein said coil comprises a pair of concentric coils wound around said penetrating member.
  23. 23.根据权利要求1所述的医疗器械,其中所述往复式致动器是气动致动器或流体致动器的其中之一。 23. The medical device according to claim 1, wherein said reciprocating actuator is one of a pneumatic actuator or fluid actuator.
  24. 24.根据权利要求12所述的医疗器械,其中所述柱塞用于通过所述医疗器械从所述活体抽出物质。 24. The medical instrument of claim 12, wherein said plunger for drawing material from the living body by the medical device.
  25. 25. —种减小穿透活体组织所需的力的方法,所述方法包括:通过往复式致动器使穿透件相对活体组织往复运动,所述往复式致动器将电能转换为往复运动;检测所述穿透件是否穿过所述活体组织;所述穿透件穿过所述活体组织时,自动切断所述往复式致动器的电能。 25. - The method of reducing species needed for penetration of body tissue, said method comprising: a reciprocating actuator body tissue penetrating member relative reciprocation of the reciprocating actuator converts electrical energy to reciprocating motion; detecting whether said penetrating member through said living tissue; said penetrating member through said living tissue, automatically cut off the electrical energy of the reciprocating actuator.
  26. 26.根据权利要求25所述的方法,其中所述检测所述穿透件是否穿过所述活体组织的步骤包括在含液注射器内移动柱塞,所述柱塞与所述穿透件内的通道流体连通。 26. The method of claim 25, wherein said detecting whether said penetrating member through said living tissue comprises the step of moving the syringe containing the liquid plunger penetrating the inner member a fluid communication channel.
  27. 27.根据权利要求沈所述的方法,其中所述柱塞耦合至向所述往复式致动器提供电能的开关。 27. The method of claim sink, wherein the plunger is coupled to the reciprocating actuator provides power to the switch.
  28. 28.根据权利要求25所述的方法,其中所述检测所述穿透件是否穿过的步骤包括压力致动器,所述压力致动器监测所述穿透件通道内的压力,其中所述压力致动器提供控制开关操作的输出,所述开关向所述往复式致动器提供电能。 28. The method according to claim 25, wherein said step of detecting whether said penetrating member through which comprises a pressure actuator, the actuator pressure monitor pressure within the actuator channel penetrating member, wherein output pressure of said actuator provides controls the switching operation of the switch to provide power to the reciprocating actuator.
  29. 29.根据权利要求25所述的方法,其中所述往复式致动器为至少一个压电元件。 29. The method of claim 25, wherein said reciprocating actuator is at least one piezoelectric element.
  30. 30.根据权利要求四所述的方法,其中所述往复式致动器为Langevin致动器。 30. The method according to claim four, wherein said reciprocating actuator is a Langevin actuator.
  31. 31.根据权利要求30所述的方法,其中所述往复式致动器为音圈。 31. The method according to claim 30, wherein said reciprocating actuator is a voice coil.
  32. 32.根据权利要求30所述的方法,其中所述往复式致动器是气动致动器和流体致动器的其中之一。 32. The method according to claim 30, wherein said reciprocating actuator is one of a pneumatic actuator and the fluid actuator.
  33. 33.根据权利要求37所述的方法,还包括使用所述柱塞通过所述医疗器械从活体抽出物质的步骤。 33. The method according to claim 37, further comprising the step of using the extracted material of the plunger from the living body by the medical device.
CN 200980144604 2008-09-15 2009-09-14 Medical tool for reduced penetration force with feedback means CN102209568A (en)

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