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

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

What have feedback device reduces the penetration power medical instrument

The cross reference of related application

It number is 61/089 for the provisional application of " have feedback device reduce penetration power medical instrument " that this PCT application requires JIUYUE in 2008 application on the 15th, title, 756 the rights and interests under 35U.S.C. § 119 (e), whole disclosures of above-mentioned application are incorporated this paper by reference into.

Technical field

The present invention relates generally to the hand-held medical apparatus, relate more specifically to that electricity drives lancet, epidural catheter plug-in unit, biopsy Medical Instruments (for example bone biopsy medical apparatus and instruments), advances the blood vessel penetrating member, spinal needle and other conduits insert pin.The present invention is applicable to and carries and remove intravital blood, tissue, medicine, bone marrow, nutrient substance or other materials.

Background technology

Epidural anesthesia is a kind of form of local anesthesia, relates to the medicine direct injection in epidural space.When the described operation of beginning, pin is inserted from skin outer layer, pass multilayer tissue, insert epidural space at last, conduit optionally passes epidural space.Local anesthetic is injected epidural space, pass through in the spinal cord and on every side the neural swound and the pain sensation by the inhibition of pain signal.Because more blunt epidural needle needs high-level power when penetrating supraspinal ligament, interspinal ligaments and ligamenta flava, operation can make the patient not feel well.A kind of complication is, because described high penetrating power and stop when described pin penetrates epidural space it almost is (the instantaneous higher power forward that at utmost reduces after the power) of transient change, the clinicist understands unexpected overshoot and pierces through cerebral dura mater.After piercing through cerebral dura mater, cerebrospinal fluid can infiltrate epidural space, makes the patient serious dura mater puncture back headache occur, can last for days, even several years.A large amount of seepages can produce the intracranial low pressure that is enough to make phleborrhexis, cause subdural hematoma and traction property Cranial nerve injury as birth trauma, cause tinnitus, hearing loss, dizziness, blepharoptosis or diplopia.

Bone marrow biopsy is used for diagnosing tumour and various osteopathia.The most frequently used bone biopsy site is preceding crista iliaca.Major defect is to penetrate the required power of osseous tissue and be generally used for making the inside twist motion of pin that the patient is not felt well and cause probability healing complication by damaged tissues.Penetration power also may make the clinicist feel tired, and causes multiple sampling to be attempted.Complication is rarely found, but can comprise hemorrhage, pain and infection.Although in the insertion and withdrawal of some operation, the patient still can produce pressure sensation, adopts suitable local anesthesia can at utmost reduce pain.Another problem is crushing samples or can not fetches part or all of sample, thus the restriction diagnosis capability.As shown in Figure 1, biopsy instrument PA1 generally includes handle (not shown) and hollow bushing 1, and the boot proximal end 1 ' of hollow bushing 1 is around the stylet 2 that connects handle.In order to penetrate cortical bone, the clinicist makes sleeve pipe and stylet pass bone and arrives bone marrow.The distal tip 3 of the interior stylet or the trocar is sharp-pointed, and has edged surface 4 like the chisel, and edged surface 4 reduces the application of force by reducing surface area.

At present, in order at utmost to reduce the probability of cerebral dura mater puncture, use the more blunt pin PA2 of custom-designed 16-18 specification (pin that is called Tuohy pin 5 for example shown in Figure 2) to carry out the epidural catheter insertion process very lentamente usually.Epidural needle, for example Tuohy pin 5 or Hustead pin have the directional curvature point 6 of minimizing pin " sharpness ", so make unexpected cerebral dura mater puncture more difficult.Bent tip also is convenient to inlying catheter is imported epidural space, and sharp opening 7 is convenient to conduit or fluid imports or removes.Regrettably, in fact described blunt bent tip design has increased the power that the clinicist must use, and makes the more difficult power forward that stops after penetrating the cerebral dura mater chamber of clinicist.In addition, Tuohy design has increased the clinicist relies on tactile feedback in the process of penetrating probability.In other words, the clinicist can be fixed against sensation " squeeze broken feel " (showing that pin passes ligamenta flava) determines the position of point in epidural space of pin, and the power forward that stops fast applying in inserting operation.However, may produce and similarly squeeze broken sense owing to penetrate its hetero-organization (for example muscle, calcification ligament or general ligament), the clinicist may not can feel the tram (needle point pass above-mentioned tissue before blocked) of needle point fully.

Develop some substitute technologies, attempted at utmost to reduce cerebral dura mater puncture risk, provided successfully the indication that epidural is placed to the clinicist simultaneously.For example, to be disclosed detection method such as (Sundar people) and equipment (its content is incorporated this paper by reference into) in 2007/0142766 the description rely on spring-loaded plunger that fluid is pushed epidural space successfully entering the back to U.S. Patent Application Publication No..Correspondingly, the clinicist receives visual detector (being that the plunger of fluid when pin opening part non-resistance moves), stops to apply forward thrust then.Similarly, U.S. Patent number is also to rely on visual detector to pass on pin successfully to enter the information of cavity to the clinicist among 5,681,283 (Brownfield).Regrettably, although visual detector is just to march forward, do not enlighten or propose the actual cause of unexpected cerebral dura mater wall puncture, promptly the clinicist passes the higher force that various organized layers stop pin then to what pin applied.

Therefore, exist to reduce the pin puncture force and to make the clinicist can better control the instrument pin that enters epidural space, Tuohy pin for example, thus reduce the probability that unexpected cerebral dura mater punctures.

Although the puncture of unexpected cerebral dura mater is a concerned issue, only locatees epidural space even may the most skilled doctor be challenged.Therefore, when pin (for example Tuohy pin) passes ligamenta flava and enters epidural space, receive that the indication needle point successfully penetrates and the immediate feedback of position helps the clinicist.Basic conventional feedback arrangement (for example feedback device shown in Fig. 2 a) comprises the pin (not shown) that connects syringe PA3 front portion 9, and wherein syringe PA3 is formed by tubular body 10, and holds the biasing element 11 that comprises as the bar of biasing element.For the indication feedback that successful epidural penetrates is provided, feedback device relies on the bias force that acts on biasing element 11, and biasing element 11 acts on the fluid in the syringe, for example saline or air then.In this hydraulic pressure feedback method, because bias force acts on fluid, fluid forwards this pressure to the opening of needle point basically.Owing to leaning against the last counteracting force that acts on needle point of tissue (for example ligamenta flava), needle point is used to prevent discharge this fluid from this syringe.Clinicist's thumb is usually as the bias force source, and this bias force source acts on plunger rod conversely.The counteracting force that clinicist's thumb is used for " sensation " tissue is applied to the flowed friction on the fluid.Yet, enter epidural space after, eliminated the reaction pressure of the tissue that acts on needle point, pressure descends and makes bias force by needle point solution be shifted out this syringe.Because its thumb " sensation " plunger rod place's pressure drop or non-resistance, the clinicist recognizes that then success penetrates epidural space.In addition, when arriving release of fluid in patient's the epidural space, the clinicist can enter the vision indication that syringe receives that success penetrates by the witness plunger from the outside.A problem of this conventional apparatus and method is to apply bias force to plunger when the clinicist is difficult in the thrust (making pin enter ligamenta flava) that applies relative syringe body.In addition, in order to prevent unexpected cerebral dura mater puncture, when applying the power forward that acts on syringe and acting on the bias force of plunger rod, the clinicist tends to so that the patient keeps stable manner to hold conventional syringe, thereby clinicist and patient is all felt a delicacy about and discomfort.

The automatic biasing element also attempt to provide the plunger to the epidural injection device to work is provided for some, and the vision indication or the feedback of target area in each also is provided in the human body that successfully punctures simultaneously, but not tactile response.For example, be that spring is used for acting on syringe plunger together with bias force among 2007/0142766 (people such as Sundar) in U.S.'s publication No..When the epidural needle that connects this syringe penetrated the cerebral dura mater chamber, pressure descended and makes spring biasing plunger.When plunger moves, because plunger rod is mobile with plunger, so plunger rod provides some visions indications at least.Similarly, U.S. Patent number be 5,024,662 people such as () Menes in (this patent is incorporated this paper by reference into) by using elastic webbing to provide the bias force that acts on plunger rod that the vision indication is provided.At U.S. Patent number is among 4,623,335 (Jackson) (this patent is incorporated this paper by reference into), and substituted device is assisted from indicated pressure visually, to determine the position of needle point.In addition, U.S. Patent number is that the working pressure pick off is converted into electronic signal with the pressure variation among 7,297,131 (Call) (this patent is incorporated this paper by reference into).Then, for example electronic signal is converted to the visual display indicator by activating lumination of light emitting diode.

Therefore, need overcome the unsolved challenge of technology of usual employing, pass the required power of organizing, can also or fetch material from subcutaneous (for example bone biopsy etc.) input (for example importing saline solution or medicine etc.) with the sharp-pointed medical element that reduces medical apparatus and instruments.

Especially enter this spatial power when significantly reducing, the vision indication from concrete human space (for example epidural space) to the clinicist, sense of touch indication, electric indication or other indications that provide penetrating member successfully to penetrate also are provided.After entering epidural space, must control or stop the identical power of subtracting immediately, penetrate cerebral dura mater to avoid (easier).

Particularly, medical instruments field need have the improvement medical apparatus and instruments of penetrating member, and this penetrating member vibrates with certain frequency, thereby reduces the required power of penetrate tissue; Reduce the tissue injury and the cicatrix amount that cause, improve the success rate that enters human space or vascular; At utmost reduce and introduce the wound location wound, the most important thing is to improve patient's comfort level, at utmost reduce possible complication simultaneously.

In the bone biopsy procedure, need the clinicist to penetrate sclerous tissues's (for example cortical bone), thereby alleviate clinicist's fatigue, subject discomfort and tissue injury with less power, improve sampling success rate and quality simultaneously.Need to detect the position that is fit to, stop to travel forward and collecting sample.Because regain penetrating member from health, thus after collecting sample, also need to open apparatus, and reduce power and alleviate the subject discomfort sense.

Also need the operation of vertebra approach, because the clinicist does not expect reaching tissue core, when carrying out the operation of vertebra approach, the clinicist wants the position that reduces strength and know needle point but power can be put on sharp-pointed relatively penetrating member, for example nib.

Also need to carry out nerve block, when carrying out nerve block, the clinicist wants the position that reduces strength and know needle point.After entering desired location, must control or stop the identical power of subtracting immediately.

The full content of all references that this paper quotes is all incorporated this paper by reference into.

Summary of the invention

Basis of the present invention is that a kind of far-end has penetrating member (for example guide needle, Tuohy pin, pencil prong, the trocar are (for example

) and be used for operation (for example intravascular injection and conduit insert biopsy needle) etc., single injection or continuous epidural anesthesia, vertebra enters, local retardance or bone biopsy etc.) hand-held medical apparatus (epidural needle for example, the bone movable detecting apparatus, spinal needle, local retardance pin, catheter guidance pin etc.), wherein said medical apparatus and instruments comprises at least one drive actuator of connecting described penetrating member (for example being positioned at the penetrating member far-end) (piezoelectrics for example, voice coil loudspeaker voice coil, solenoid, pneumatic actuator, fluid actuator or any vibration actuator or translatable actuator etc.), the described penetrating member of wherein said drive actuator translation, make its reciprocating motion, produce less displacement, thereby reduce the required power of penetrate tissue.

In addition, the present invention includes the device that vision, audition or tactile response feedback are provided by various testing agencies (such as but not limited to electric device, magnetic devices, pressure apparatus, capacitive means, induction installation etc.), successfully penetrate various tissues or health internal pore to indicate, for example epidural space makes the clinicist know the power supply of when closing and limiting described driving mechanism.

The maximum strain limit obstruction of piezoelectric self relies on traditional, single or piles up the actuator technologies that the piezoelectric assembly activates.Because the maximum strain limit of conventional piezoelectric materials is about 0.1% of polycrystalline piezoelectric (for example lead zirconate titanate (PZT) polycrystalline (being also referred to as pottery) material), 0.5% of mono-crystalline piezoelectric materials needs a lot of batteries to realize (for example can be used for the hand-held medical apparatus of tissue penetration operation) useful displacement or actuating.Yet, when using a lot of start battery handpiece components, also need to make the size of instrument to surpass the available bioassay design of handheld instrument.

Developed the curved actuator design of opening, this curved actuator design provides piezoelectric heap strain displacement to amplify.Should curvedly open design and comprise that the piezoelectric that places in framework, platen, end cap or the shell drove battery.The geometry of described framework, platen, end cap or shell provides the axial or lengthwise movement that drives battery to amplify, to obtain this curved displacement greatly of opening assembly at specific direction.In fact, this curved actuator is the motion (or power) of second direction with the stress transmission of a direction more effectively.The curved piezo-activator of opening can be considered intermediate frequency actuator, for example 25-35kHz.The curved actuator of opening can have plurality of embodiments.For example, in one embodiment, the curved actuator of opening is that U.S. Patent number is the curved actuator of opening of the cymbals type described in 5,729,077 (Newnham), and this patent is incorporated this paper by reference into.In another embodiment, a curved actuator is that U.S. Patent number is the scale-up version piezo-activator described in 6,465,936 (Knowles) (" APA "), and this patent is incorporated this paper by reference into.In yet another embodiment, actuator is similar but is not limited to U.S. Patent Application Publication No. is (Bromfield) disclosed Langevin or bolt dumbbell shape actuator among the 2007/0063618A1, and this patent application prospectus is incorporated this paper by reference into.

In a preferred embodiment, the present invention includes hand-held instruments, described hand-held instruments comprises body, places described intrinsic curved penetrating member or " sharply " part of opening actuator and being connected described curved actuator one side.In broad range of the present invention, described penetrating member can be hollow or solid penetrating member.Described actuator can have the endoporus that runs through far-end and near-end or be positioned at side opening on the penetrating member coupling.Therefore, penetrate the part, do not need after the use penetrating member is sterilized disposable.If described penetrating member is hollow penetrating member, described hollow penetrating member forms the hollow tubular structures with sharp distal.The hollow center part of described penetrating member is concentric with the described endoporus of described actuator, forms the continuous cavity of described actuator body far-end to described penetrating member near-end jointly.For example, the described curved actuator of opening can utilize curved cymbals type actuator technologies or the scale-up version piezo-activator APA of opening) technology.The described curved actuator of opening provides traditional hand-held instruments further amplification and improvement performance in addition.For example, amplification can improve about 50 times.In addition, the described curved actuator of opening makes the handpiece configuration have simpler design and than small dimension.

One embodiment of the present of invention are resonant drive intravascular injection pins, and described resonant drive intravascular injection pin is rolled or depletion in order to the insertion force and the minimizing vascular system that reduce described penetrating member.

An alternate embodiment of the present invention is a kind of power of subtracting epidural needle, and the described power of subtracting epidural needle can better be controlled the clinicist and entered epidural space, thereby at utmost reduces the accident puncture of dural sheath.In this embodiment, actuator (for example Langevin actuator (being commonly referred to the Langevin pick off)) has the hollow penetrating member that connects described actuator distal end part, for example hollow needle.In this embodiment, the other end of Langevin actuator may be opened.Opening comprises the hollow parts that extends to described actuator proximal end from described actuator distal end continuously.Described distal openings is consistent with described hollow penetrating member.Plunger with handle, axle and sealing member also is connected the actuator of the described sharp-pointed part other end.Described plunger axis places the continuous hollow interior of described actuator slidably.Described sealing member connects the distal portions of described plunger axis, separates the far-end volume of described actuator hollow interior and the near-end volume of described hollow interior.Because described plunger axis slidably arranges, in order to adapt to the motion of described axle at distal direction, described plunger also slidably arranges, and reduces the far-end volume of described hollow interior, increases described near-end volume.On the contrary, in order to adapt to the motion of described axle at proximal direction, described sealing member also can move along proximal direction, thereby reduces the near-end volume of described hollow parts, increases described far-end volume.Act on the effective motion that drives described plunger axis and described plunger seal of described plunger handle external force on hand.If by electrically activating, the hollow point that penetrates that described actuator is transferred to described hollow needle with the compression and the expansion of described piezoelectric part.The Langevin actuator can be considered the altofrequency actuator, for example＞and 50kHz.

Another embodiment of the present invention provides a kind of bone marrow biopsy apparatus, described bone marrow biopsy apparatus has shell and actuator, for example the Langevin actuator (is 6 referring to U.S. Patent number for example, 491,708 patent (people such as Madan), its whole disclosures are all incorporated this paper by reference into), first body part and second body part that comprise described actuator, form piezoelectric between described first body part and described second body part, wherein said actuator to small part places in the described shell.The present invention also comprises handle and the trocar sheath with open distal end and open proximal, pin for example, and described sleeve pipe is positioned at the distal portions of described actuator.In the aspect according to present embodiment, the present invention also comprises stylet, and described stylet has the distal tip that penetrates that connects described distal tip described handle relatively partly, and wherein said stylet slidably passes the center cavity and the sleeve pipe of described body.The far-end of described actuator forms distal openings, and the near-end of described actuator forms proximal openings, and the central hollow hole extends to institute's proximal openings from described distal openings, thereby limits hollow passageway.

Or rather, described trocar sheath is the hollow pipe of fixedly connected described actuator distal end, makes that described telescopic described open proximal is consistent with the distal openings of described actuator distal end.Described stylet places the center of described actuator slidably by described hollow passageway and described far-end from described near-end.Described stylet has predetermined length, makes described stylet pass the center of described trocar sheath slidably, and the described distal tip of described stylet is stretched out described telescopic described open distal end.

Various actuator of the present invention must be electrically connected with the external electric signal source.After the signal of telecommunication started, described actuator was a mechanical energy with conversion of signals, and this mechanical energy causes the vibration of end effectors such as adhering to pin or stylet.If the Langevin actuator, the vibration that piezoelectric produces produces the standing wave by whole assembly, for example standing wave in Figure 17 figure.Because under given frequency, standing wave is made up of the position of continuous zero shift (node or zero node) and maximum displacement (antinodal points shows), depends on the position of measuring displacement along the displacement of any some generation of described actuator.Therefore, the design length of common horn makes provides the far-end of described horn at the antinodal points place when the described device of operation.Like this, the described far-end of described horn can produce the big longitudinally vibration displacement along described relatively actuator major axis.On the contrary, described zero node is best suited for increasing the position of hole opening or groove, makes to connect external device (ED) and described actuator.Shown in the ZN line, hole open S P is consistent with zero node location, and the less displacement at zero node place is less to the wearing and tearing of institute's connecting device.

Therefore, in an alternate embodiment, described actuator can be formed with the distal openings that is positioned at described actuator distal end, be positioned on actuator at least a portion opening and from described distal openings extend and with the hollow hole of described hole open communication.Preferably, described hole opening can be the side opening on the described actuator electrode arm side.More preferably, described hole opening is usually located at the zero node location (preferably being positioned at the center) of described actuator, most preferably is positioned at the zero node location center of described actuator electrode arm side.In addition, a kind of feedback device of indicating body position (for example epidural space) successfully to penetrate of being used to, for example above-mentioned disclosed any conventional feedback arrangement is by connecting described hole aperture position or best described side opening is communicated with present embodiment.Perhaps, any device of energy conveyance fluid, for example conduit or conventional syringe can connect described hole aperture position or be preferably described side opening.

The present invention relates generally to concussion or translation and activate hand-held instruments, described concussion or translation activate handheld apparatus and are used to penetrate various bodily tissues, to carry and to remove body fluid, tissue, nutrient substance, medicine, Therapeutic Method, placement or to dial and remove conduit etc.For example, as for the piezoelectricity apparatus, the present invention is a kind of handpiece, described handpiece comprises body, place described intrinsic at least one piezoelectric element and the sharp-pointed part that is used for tissue penetration (for example to be positioned at the syringe of described hand-held instruments distal portions, epidural needle or biopsy needle), and have by any known testing agency (such as but not limited to electric device, magnetic devices, pressure apparatus, capacitive means, induction installation etc.) provide the vision indication, the feedback device of successful penetrating body internal clearance (for example epidural space) is indicated in audible indication or sense of touch.

In addition, owing to use correct circuit, the described hand-held medical apparatus that comprises actuator has a kind of device, and described device is used for cutting off the external power source of described drive actuator (for example one or more piezoelectric elements, voice coil loudspeaker voice coil, solenoid, other vibration actuators or translatable actuator etc.) when wearing out particular organization or body interior (for example epidural space).The device that is used to cut off described drive actuator external power source can be used as the part of said apparatus and implements, to provide vision indication, audible indication or sense of touch indication or jointly as self-contained unit.Penetrate particular organization or for example behind the epidural space inside, preferably by incorporating correct circuit configuration into device that above-mentioned electric device realizes being used to cut off described drive actuator external power source, triggering switching device shifter, thus the power supply that cuts off described drive actuator.U.S. Patent number is that people such as () Bell describes this type of device in 5,575,789, and whole disclosures of this patent are all incorporated this paper by reference into.By described electric shearing device is provided, successfully penetrate epidural space, for example, the clinicist receives one or more vision indications of penetrating given body inside, audible indication and sense of touch indication and as the apparatus power consumption of second indication.In addition, if by cutting off described drive actuator power supply the apparatus power consumption takes place, further wear out organize required power or forward power can stop, can reducing the probability of unnecessary body region puncture (for example unexpected dura mater puncture) conversely.

In addition, when in body, regaining described penetrating member, have the invention provides of concrete control electronic installation and subtract power.

In one embodiment, described penetrating member or sharp-pointed tube-like piece are the parts of intravascular injection pin.

It is in another embodiment, described that to penetrate sharp-pointed tube-like piece be the Tuohy pin.

In another embodiment, described penetrating member or sharp-pointed tube-like piece are the trocar and stylet assembly, for example

Biopsy needle.

In another embodiment, described penetrating member or sharp-pointed tube-like piece are the pencil prong.

In another embodiment, described penetrating member or sharp-pointed tube-like piece are the part of trocar hand-hole.

The detailed description of consulting various exemplary embodiments of the present invention is described described feature of the present invention and other features, and perhaps this feature will become obvious.

Description of drawings

Below with reference to accompanying drawing exemplary embodiment of the present invention is described.

Fig. 1 is the fragmentary isometric view of the biopsy needle far-end of prior art;

Fig. 2 is the partial side view of the epidural needle far-end of prior art;

Fig. 2 a is the plane graph of the injection with low resistance of tradition, prior art;

Fig. 3 is the figure of explanation penetrating member penetration power;

Fig. 4 is the cross section as the Langevin actuator (being commonly referred to the Langevin pick off) of the actuator in the first embodiment of the invention;

Fig. 4 a designs for pin, and side opening is positioned at the penetrating member hub, so that (for example) provides outside inlet for pressure transducer joint or conduit implantation site.

Fig. 5 is the cross section of the intravascular injection pin that uses in the first embodiment of the invention;

Fig. 6 is the cross section of the plunger that uses in the first embodiment of the invention;

Fig. 6 a describes the present invention who comprises wiring and shell sterilization cover;

Fig. 6 b describes and to comprise the battery that connects described actuator end and the present invention of inverter chamber;

Fig. 7 is the cross section of first embodiment of the invention;

Fig. 7 a is the cross section of the alternate design of first embodiment of the invention, and the present invention comprises the side opening that is positioned on the penetrating member hub;

Fig. 8 is the cross section of another alternate design of first embodiment of the invention among Fig. 7;

Fig. 9 is the isometric view of second embodiment of the invention;

Fig. 9 a is the isometric view of the alternate design of second embodiment, connects the position of pressure transducer or inserts conduit by the side opening on the described actuator;

Fig. 9 b is the isometric view of the more preferably alternate design of second embodiment, connects the position of pressure transducer or inserts conduit by the side opening on the described penetrating member hub;

Figure 10 a is the cross section that is used for the interior stylet of third embodiment of the invention;

Figure 10 b is the cross section of the outside penetrating member (for example trocar) that is used for third embodiment of the invention;

Figure 10 c is the cross section of relative position of the interior stylet of displayed map 10a, described in stylet be arranged in the outside penetrating member of Figure 10 b that is used for third embodiment of the invention;

Figure 11 is the cross section of third embodiment of the invention;

Figure 12 is the cross section of fourth embodiment of the invention;

Figure 13 is the cross section that connects the penetrating member of the scale-up version piezo-activator that is used for fifth embodiment of the invention;

Figure 13 a is the cross section of the alternative APA design of the penetrating member with side opening of the present invention's use;

Figure 14 is the cross section of fifth embodiment of the invention;

Figure 14 a is the cross section of fifth embodiment of the invention, and this embodiment uses the penetrating member of the side opening with Figure 13 a;

Figure 15 is the cross section of sixth embodiment of the invention, and this embodiment comprises cymbals type actuator;

Figure 16 is the cross section of sixth embodiment of the invention, and this embodiment uses the penetrating member of the side opening with Figure 13 a;

Figure 17 shows the dependency between the side opening position of standing wave zero node and Langevin actuator, does not wherein show actuator handle;

Figure 17 a shows the dependency between the side opening position of standing wave zero node and the penetrating member that is connected the Langevin actuator;

Figure 18 a is the functional diagram of seventh embodiment of the invention, and this embodiment describes the side opening at zero node location place on the Langevin actuator, does not wherein show handle;

Figure 18 b is the functional diagram of seventh embodiment of the invention, and this embodiment comprises the side opening of Figure 18 a that is communicated with central passage, and described central passage is extended along the length of Langevin actuator, does not wherein show handle;

Figure 18 c is the sketch of eighth embodiment of the invention, and this embodiment comprises two side openings that are communicated with the pin adnexa, and a side opening connects the front portion of Langevin actuator, and another side opening connects penetrating member, does not wherein show actuator handle.

Figure 18 d is the sketch of eighth embodiment of the invention, and this embodiment comprises the side opening that connects short hole and be communicated with the pin adnexa, and described side opening also connects the front portion of Langevin actuator, wherein the actuator handle of displayed map 18a not;

Figure 19 is the accompanying drawing of ninth embodiment of the invention, and this embodiment comprises the conventional syringe of Fig. 2 a, and described conventional syringe connects actuator side hole site shown in Figure 180, does not wherein show actuator handle;

Figure 19 a is the accompanying drawing of ninth embodiment of the invention, and this embodiment comprises the conventional syringe of Fig. 2 a, the side opening position of the penetrating member hub shown in the described conventional syringe connection layout 18c, and described actuator also connects described penetrating member hub, does not wherein show actuator handle;

Figure 19 b is the accompanying drawing of the pressure sensing pump of connection penetrating member;

Figure 20 a is the viewgraph of cross-section of tenth embodiment of the invention, and this embodiment uses voice coil loudspeaker voice coil as drive actuator;

Figure 20 b is the viewgraph of cross-section of tenth embodiment of the invention, and this embodiment uses voice coil loudspeaker voice coil as drive actuator, wherein the position opposite of magnetic part and coil among the position of magnetic part and coil and Figure 20 a;

Figure 20 c is the equidistant viewgraph of cross-section of tenth embodiment of the invention, and this embodiment uses two coils;

Figure 20 d is the cross-sectional side view of tenth embodiment of the invention, and this embodiment uses the solenoid with spring;

Figure 21 is the illustrative diagram that is used for the power cut-off device of various embodiments of the invention.

The specific embodiment

Fig. 3 to Figure 21 illustrates the preferred embodiments of the present invention, the identical and respective element of identical numeral.In order to describe the relative configuration of the various elements of the present invention, the narrow sense definition of term " far-end ", " distally ", " near-end " or " near-end ground " can only not refer to specific strict direction, but, based on context use accompanying drawing and reference number to define described relative position as erect-position character definition relative position.The ending of this description provides the tabulation of various reference label.In addition, the title of on June 27th, 2008 application is that 12/163,071 full content is all incorporated this paper by reference into for " reducing the penetration power medical instrument " U.S. A.S.N. number.

For example, the described effectiveness utilization of the present invention of above preferred embodiment subtracts power optimization and penetrates tissue or the material that finds in the human body.In fact, during the high speed operation penetrate tissue of apparatus penetrating member part (for example pin), enter required power and reduce.In other words, penetrating member (being also referred to as " tube-like piece "), pin for example during axial vibration during insertion (for example moving back and forth), can be observed and subtracts stress effect, and the agglutinating mechanical energy between tissue and the penetrating member occurs being enough to break.If required pin displacement, can reach the threshold limit of mechanical energy to the ultrasonic frequency scope at sound wave.

To subtract stress effect in order utilizing, to design medical apparatus and instruments of the present invention and be designed to make and penetrate distal tip and partly realize short stroke distance or displacement, and with the sinusoidal vibration of high-penetration frequency.Utilize as the described various appliance configuration of above-mentioned embodiment, determine that the sinusoidal motion of described sharp distal point must comprise that the piezoelectricity instrument is with 20-50kHz (most preferably being 20-25kHz) frequency realization 35-100 μ m displacement, more preferably 50-100 μ m.Connection causes described motion with the penetrating member 20 of the actuating piezo-activator of 50-150Vpp/mm (most preferably being 90Vpp/mm) operation, and Vpp is called peak-to-peak voltage.

For example, Fig. 3 shows that resistance penetrates the diagram of the degree of depth of sclerous tissues with respect to the bone biopsy needle.In Fig. 3, curve indicates A and represents the data of pin under " closing " or non-vibration state, and curve indicates the data that B represents to have the medical apparatus and instruments of pin, and described pin is that 38kHz, displacement are that the piezo-activator of 100 μ m vibrates by frequency.Can obviously find out that curve B is presented under the non-vibrating situation from Fig. 3, penetrate the required power of material, for example the power represented of curve B far above vibration pin required power.

Only for example, with reference to figure 4, Langevin actuator (usually with numeral 100 expressions) comprises piezo-activator, this piezo-activator comprises the body with central hollow passage, displaceable (being also referred to as " horn ") 110, anchor (being also referred to as " back fixation piece ") 112 and at least one piezoelectric element 114, but preferably includes a plurality of piezoelectric elements 114.Particularly, each piezoelectric element 114 forms piezoelectric ring, and this piezoelectric ring forms hollow parts, and wherein piezoelectric element 114 is fixed in the body, and is connected between horn 110 and the back fixation piece 112.Hollow or solid bolt 116 places the core of back fixation piece 112, and the core that runs through at least one piezoelectric element 114 extends, and the core at horn 110 stops then.Bolt compression back fixation piece 112, at least one piezoelectric element 114 and horn 110.Horn 110 and back fixation piece 112 are made by metal (for example titanium, rustless steel), pottery (comprising polycrystalline and monocrystalline inorganic material), plastics, composite, or preferably made of aluminum.Bolt 116 is by making with horn 110 and back fixation piece 112 identical materials.In order to prevent that patient and clinicist from being shocked by electricity, at least a portion of Langevin actuator 100, preferably at least a portion of whole at least rear portion body 112, all at least one piezoelectric elements 114 and horn 110 all places in the handle 118.The metal label (not shown) place that forms between the opposite face of at least one piezoelectric element 114 is electrically connected.This label can be coupled by the electric conductor 114b that connects alternating current power supply or battery (for example being positioned at battery chamber of the present invention).Handle 118 comprises housing parts and sealing member 120, and this housing parts can be plastics or metal, and sealing member 120 can be elastomer.Sealing member 120 prevents the core turnover of moisture from back fixation piece 112, piezoelectric element 114 and horn 110.The core of back fixation piece 112, piezoelectric element 114 and horn 110 is consistent with the hollow parts of bolt 116, bolt 116 forms continuous hole 126 in Langevin actuator 100, hole 126 has distal openings 122 that is positioned at distal face 121 and the proximal openings 124 that is positioned at distal face 121 opposites.This actuator adds Rule conical head 123 so that connect clear.

Will be appreciated that the quantity of piezoelectric element 114 does not constitute limitation of the invention, within broad range of the present invention, comprise one or more piezoelectric elements 114.

According to an alternate embodiment, can form the side opening (not shown) in horn 110 sides of this actuator, hole 126 is communicated with from distal openings 122 extensions of distal face 121 and with this side opening continuously.

The functional performance of described medical apparatus and instruments is partly driven by piezoelectric element.Piezoelectric element 114, accurate, the controlled displacements of for example one or more piezoelectric rings energy, and can be with the characteristic frequency produce power.Because the unsymmetry of crystal structure, piezoelectric can expand to be called inverse piezoelectric effect when being exposed in the electric input, also may shrink under negative voltage.Pass through piezoelectric coefficient d ₃₃, d ₃₁And d ₁₅Multiply by electric field E and quantize piezoelectric strain, to determine the induced strain x of described material.Ferroelectric polycrystalline material, for example Barium metatitanate. (BT) and lead zirconate titanate (PZT) present piezoelectricity when being subjected to electric polarization.The direct materials used of being made up of disk or multi-layered type of simple apparatus passes through the induced strain of extra electric field.Alternating field tuning under the mechanical resonant frequency of piezoelectricity apparatus can produce acoustic vibration and supersonic vibration.Piezoelectric element can be made into different shape and size.In one embodiment, piezoelectric element can be 2-5mm (diameter), 3-5mm (length), can be made up of several folded rings, disk or plate.The accurate dimension of this piezoelectric element depends on performance.Piezoelectric monocrystal or polycrystalline material can be by at least a compositions the in lead zirconate titanate (PZT), multilamellar PZT, PMN-PT (PMN-PT), multilamellar PMN-PT, zinc niobate lead-lead titanates (PZN-PT), polyvinylidene fluoride (PVDF), multilamellar PVDF and other ferroelectric polymers.The above-mentioned material that also can mix is with the characteristic that changes described medical apparatus and instruments with improve its performance.Described tabulation does not comprise all possible piezoelectric.For example, existing big quantity research about unleaded (Pb) material, this unleaded (Pb) material just can use in the present invention once research and development.

In the embodiment shown in Fig. 4 a, side opening SP is positioned on the hollow needle 130 penetrating member hubs 525.In this alternate embodiment, hollow needle 130 penetrating member hubs 525 are preferably the combination of metal or molding metal insert.Side opening SP should comprise the female thread Rule tapered opening that connects lower resistance conventional syringe PA3.

Refer now to Fig. 5, the penetrating member (usually with numeral 20 expressions) that is used for first embodiment of the invention comprises connection fittings 128, and connection fittings 128 connect the near-end 130b and the far-end 130a of the hollow needle 130 of penetrate tissue.Only for example, connection fittings 128 can comprise Luer cone, plastics or metal fittings.

Refer now to Fig. 6, the plunger 12 that is used for first embodiment of the invention comprises the plunger handle 132 and the plunger seal 136 that is connected plunger axis 134 far-end 134b that connects plunger axis 134 near-end 134a.This plunger seal is used to seal handle 118, so that pollutant (for example water or body fluid) can not reach this actuator component or electrical connector.In another embodiment, this plunger can form vacuum in described hollow penetrating member, to extract body fluid and/or tissue out, for example is used for the sampling of soft tissue biopsy.

In most preferred embodiment, side opening is positioned on the penetrating member hub 525 at end junction point place.

Refer now to Fig. 7, first embodiment of the invention for example penetrates introducer (usually with numeral 200 expressions) and comprises actuator, Langevin actuator 100 for example shown in Figure 4, and the penetrating member 20 of Fig. 5 connects the distal face 121 of described actuator.Pin connection fittings 128 are threaded fittings, and Rule cone joint, compression fitting or similar accessory, and hollow needle 130 is coupled on the segment distal face 121 make it be communicated with the far-end volume in hole 126 continuously.Plunger handle 132 can be threaded, clamping, compression bolt 116, with the fixing plunger 12 of Fig. 6.The present invention can sterilize by steam sterilization, sterilization cover, gamma ray, ethylene oxide,1,2-epoxyethane (ETO) etc.For example, Fig. 6 a describes and is used for together with the wiring of the present invention's use and the sterilization cover 115 of shell.The preferred material of pin connection fittings 128 is metal or molding metal insert.Fig. 6 b shows Langevin actuator 100, and Langevin actuator 100 has the battery of this actuator end of connection and the possible configuration of inverter chamber 117.

Get back to Fig. 4 and Fig. 7, apply the outside alternating current of preset frequency at least one piezoelectric element 114 after, Langevin actuator 100 changes shape reactively with sinusoidal manner, therefore, change the relative position that is connected and fixed the distal face 121 of plunger handle 132 fixed positions in place relatively by bolt 116 by predetermined displacement.Because alternating current is sinusoidal signal, the result who activates piezoelectric element 114 is that the sine of horn 110 distal faces 121 moves back and forth and moving back and forth of pin 130 subsequently, thereby reduces the required power of penetrate tissue.As previously mentioned, can directly provide from the dc source (for example on-board batteries) of coupling inverter (for example agitator/amplifier etc.) or alternating current power supply and exchange energising, described inverter is coupled piezoelectric elements 114 conversely.Because wiring and joint need more sterilization characteristics, described dc source is a more preferred embodiment.

Fig. 7 a describes similar invention as shown in Figure 7, but comprises the penetrating member hub 525 with the side opening SP that connects hollow needle 130.Described configuration can be installed in the side opening SP pressure transducer, in case dismounting side opening SP will provide to be inserted into conduit or to remove fluid.Only by being fabricated to disposable hollow needle 130, the apparatus of whole service does not have pollution risk because conduit or fluid can not pass actuator, so compare with Fig. 7, this may be a preferred embodiment.

With reference to figure 8, supporting introducer (usually with numeral 201 expression) and Fig. 7 to penetrate introducer 200 similar, described supporting introducer also comprises conduct, the braced wing 111 that exists of flat for example, the user can hold braced wing 111, as described in Figure 17 hereinafter, braced wing 111 radially extends from the outer surface that forms horn 110 machineries zero nodes.Side opening SP (not shown) can be from described braced wing clockwise or be rotated counterclockwise 90 degree, and this may provide the position of the withdrawal of drain sample, conduit insertion etc.

In alternate embodiment of the present invention, the introducer 201 conducts catheter introducer (usually with numeral 202 expressions) as shown in Figure 9 that penetrates of Fig. 8 exists.In the present embodiment, import plunger with it from described apparatus near-end, not as good as importing conduit 129 from described apparatus near-end, pass through hole 126 holding conduits 129 as shown in Figure 4 then, conduit 129 can pass hollow needle 130.Hollow needle 130 inserts formation subcutaneous in back in patient's body, and conduit 129 imports in the body by described subcutaneous.After success imports, can be by separating described actuator and hollow needle 130 from horn 110 decoupling connection fittings 128.

Fig. 9 a shows more preferred embodiment 202b, and side opening SP allows conduit 129 to import the present invention, and does not pass through described near-end as shown in Figure 9.Described configuration can be installed in the side opening SP pressure transducer, in case dismounting side opening SP just can insert conduit or remove near the fluid of described apparatus distal face 121.Because conduit or fluid can not pass whole actuator, the apparatus of whole service does not have pollution risk, so compare with Fig. 9, more preferred embodiment 202b is likely preferred embodiment.

In the most preferred embodiment 202c shown in Fig. 9 b, the side opening SP authorized pressure pick off that is positioned on the penetrating member hub 525 is installed in side opening SP, in case dismantle side opening SP, will provide the inlet of instrument (for example conduit 129) insertion or drain fluids.Because conduit or fluid can not pass actuator, have only hollow needle 130 to pass actuator, the apparatus of whole service does not have pollution risk, so compare with Fig. 9, most preferred embodiment 202c is likely preferred embodiment.

Refer now to Figure 10 a, interior stylet (usually with numeral 14 expressions) comprises the interior stylet needle handle 142 of die needle shaft 144 near-ends in connecting.Interior die needle shaft 144 far-ends on needle handle 142 opposites are sharp-pointed interior die needle point 146.For die needle shaft 144 in supporting, the trocar sheath needle tubing shown in Figure 10 b (usually with numeral 15 expressions) comprises the trocar connection fittings 148 that connect overcoat bobbin body 150 near-ends, and trocar connection fittings 148 are the tubular structure opening of the other end.Trocar connection fittings 148 are hollow, so that overcoat bobbin body 150 can be placed in one.In addition, one of them of opening that is formed at trocar body 150 other ends is for distal cannula pin opening 152, and its outer wall forms distal cannula needle point 154.Shown in Figure 10 c, interior die needle shaft 144 slidably places in the overcoat bobbin body 150 with interior die needle point 146, and interior die needle point 146 stretches out distal cannula needle point 154.Interior stylet 14 shown in Figure 10 a and the trocar sheath needle tubing 15 shown in Figure 10 b be common form be similar to the trocar structure (for example

The biopsy instrument).

Refer now to Figure 11, interior stylet 14 slidably places in the hole 126 of trocar sheath needle tubing 15 shown in Langevin actuator 100 shown in Figure 4 and Figure 10 b, and trocar sheath needle tubing 15 connection electrode arms 110 form bone movable detecting apparatus (usually with numeral 300 expressions).Interior stylet 14 extends in some way, therefore, the complete contact bolt 116 when in place of handle 142, interior die needle shaft extends from handle 142, pass proximal openings 124, hole 126 and the hollow parts of overcoat bobbin body 150, stop as the position of interior die needle point 146 beyond distal cannula needle point 154 at last.In the present embodiment, when at least one piezoelectric element 114 of Langevin actuator 100 shown in Figure 4 drove with electric conductor 114b electricity by preset frequency, the anti-node position at horn 110 distal faces 121 places was transferred in the motion of ring compression and expanded form.Described then motion is shifted to driving the trocar sheath needle tubing 15 shown in Figure 10 b.

In an alternate embodiment, senior bone movable detecting apparatus shown in Figure 12 (usually with numeral 400 expressions) comprises all elements of bone movable detecting apparatus 300 shown in Figure 11, after driving Langevin actuator 100 shown in Figure 4 with the preset frequency electricity, described motion is shifted and is the driving of interior stylet 14.In order to carry out described function, the position of trocar sheath needle tubing 15 shown in interior die needle shaft 14 and Figure 10 b is opposite with the configuration of Figure 11 shown in Figure 10 a.For example, in senior bone movable detecting apparatus 400, trocar sheath needle tubing 15 connecting bolts 116.In addition, interior stylet 14 extends makes complete contact electrode arm 110 distal faces 121 when in place of handle 142, interior die needle shaft 144 extends from handle 142, pass distal openings 122, hole 126 and the hollow parts of overcoat bobbin body 150, stop as the position of interior die needle point 146 beyond distal cannula needle point 154 at last.

Although just described described embodiment as the Langevin actuator 100 of actuating mechanism, the present invention is not limited thereto.For example, as shown in figure 13, the near-end 513a with hollow tubular structures of penetrating member 513 sharp distal point 513b connects scale-up version piezo-activator (APA) 510, forms APA pin (usually with numeral 16 expressions).Scale-up version piezo-activator (APA) 510 comprises framework 512 and the piezoelectric 514 that is compressed in the framework 512, and framework 512 is made by metal (for example pyrite or rustless steel) usually.APA hole 526 can be extended from distal face, passes the proximal end face 512a of piezoelectric 514 and framework 512.Hollow penetrating member 513, for example hypodermic needle, the distal face 512b of connecting frame 512 makes hollow parts and APA hole 526 concentric alignment.As shown in figure 14, APA pin 16 can place in the handle 518, forms APA syringe (usually with numeral 500 expressions).Concerning present embodiment, importantly, the framework 512 proximal end face 512a of scale-up version piezo-activator (APA) 510 must be fixed to handle 518 inside at junction point 516 places as shown in the figure, therefore, APA hole 526, hollow penetrating member 513, handle proximal openings 524 and handles distal opening 521 form continuous passage, and fluid can flow into the patient by this continuous passage.Figure 13 a and 14a show alternate embodiment 16b and 500b respectively, and detachable penetrating member hub 525 makes the disposable part that penetrates have reusable active exercise handle, and wherein penetrating member hub 525 as previously mentioned.

During operation, piezoelectric 514 expands in the cycle at alternating voltage, and the framework proximal end face of relative formation and distal face 512a, 512b court are moved inward each other.On the contrary, when piezoelectric 514 compressed in opposite ac cycle, framework proximal end face and distal face 512a, 512b took place separated from one another to outer displacement.Yet, in the present embodiment, the junction point 516 of the fixedly connected body 518 of proximal end face 512a of this framework, therefore, any motion of piezoelectric heap only can make distal face 512b relative motion, thereby makes penetrating member 513 motions.

Two examples that are suitable for scale-up version piezo-activator (APA) are non-radial type actuator and trough of belt or radial type actuator.U.S. Patent number is mechanics, operation and the design details that 6,465,936 (people such as Knowles) have described radial type or trough of belt APA example, and its full content is all incorporated this paper by reference into.The Cedrat APA50XS (all rights reserved for Cedrat Technologies, in June, 2005) that the example of non-radial type APA is described in the Cedrat Piezo catalogue " Piezo actuator and electronic product ", sold by Cedrat Technologies company.

Preferably, APA of the present invention operates in 100Hz to 20kHz frequency range, more preferably 100Hz to 1kHz.

Perhaps, actuator of the present invention can be cymbals type actuator.For example, in Figure 15, cymbals type syringe (usually with numeral 600 expressions) comprises that cymbals type actuator 610, cymbals type actuator 610 comprise two end caps 612 with distal end cap 612b and proximal end cap 612a, forms at least one piezoelectric element 514 between the described end cap.Described cymbals type syringe is positioned at the center in cymbals type hole 626.The mechanical response that end cap 612 strengthens electric input, or strengthen the electric output that mechanical load produces on the contrary.Meyer Jr., people such as R.J. are " using the curved displacement of opening the electroactive material of pick off of cymbals type to amplify ", and pick off and actuator A 87 (2001) have described the actuator technologies details among the 157-162.For example, the curved thickness of opening cymbals type actuator of Pyatyi is less than 2mm, and weight is less than 3g, and resonates between 1 to 100kHz according to geometry.Because slim cymbals type design, the altofrequency radial motion of this piezoelectric is converted into low frequency (about 20-50kHz) displacement movement by covering the chamber.U.S. Patent number is the example that 5,729,077 (people such as Newnham) described cymbals type actuator, and this patent is incorporated this paper by reference into.Although described end cap shown in the drawings is circular, this end cap is not limited in a kind of shape or design.For example, people such as Smith N.B. are in " being used to improve the rectangle cymbals type array of ultrasonic percutaneous insulin administration ", J.Acoust.Soc.Am., and the 122nd volume discloses rectangle cymbals type end cover designs in the 4th phase (in October, 2007).Cymbals type actuator utilizes piezoelectric piezoelectric charge coefficients d ₃₃(being applied to direction 3 inducedstress of the per unit field of direction 3) and d ₃₁The combined expanded advantage that (being applied to direction 1 inducedstress of the per unit field of direction 3) shrinks, together with the curved Zhang Weiyi of end cap 612, this cymbals type actuator as described in Figure 15.The design of end cap 612 allows the stress that helps required direction is made the vertical and horizontal response, thereby according to formula d _Eff=d ₃₃+ (A*d ₃₁) the effective piezoelectric charge constant (d of generation _Eff).Because d ₃₁Be negative, and end cap 612 when crooked amplification coefficient (A) can only compare up to 100 with piezoelectric, the displacement increase that this cymbals type actuator produces is comparatively obvious.End cap 612 can be made by various materials, for example pyrite, steel, titanium or KOVAR ^TM, KOVAR ^TMBe the permivar with the thermal expansion compatibility of Pyrex, Pyrex allow at certain temperature range, optimize and carry out direct mechanical under performance and the application conditions and be connected.End cap 612 also provides extra mechanical stability, thereby guarantees the life-time service life-span of cymbals type actuator.

Cymbals type actuator 610 drives penetrating member 513.When cymbals type actuator 610 is started by alternating current, power frequency sinusoidal vibration relatively.Because end cap 612a is fixed on the medial wall of body 518, when cymbals type actuator 610 started, end cap 612b was relative to moving along the body that is parallel to this medical apparatus and instruments hypothesis long axis direction.In addition, piezoelectric 514 compresses in start-up course and when expanding (partly cause is the amplification that end cap 612 design causes), the displacement that the relative piezoelectric 514 of the displacement of penetrating member 513 causes is amplified.For example, the only movable separately about 1-2 micron of piezoelectric 514, but after connecting end cap 612, whole cymbals type actuator 610 can produce the power of about 1kN (225lb-f) and the displacement of about 80-100 micron.This moves through the amplification length travel that penetrating member 513 further is converted into the 100-300 micron.For the situation of the higher displacement of needs, can be at end cap to piling up some cymbals type actuators 610 between the end cap, to increase vertical total displacement of penetrating member 513.Figure 16 shows alternate embodiment 600b, and detachable penetrating member hub 525 makes this disposable part that penetrates have reusable active exercise handle.

In alternate embodiment of the present invention, form and be formed at other hole openings of the channel connection in this actuator body, for example the Langevin actuator.Figure 17-Figure 19 at described alternate embodiment, it should be noted especially, for clear, does not show described Langevin actuator handle 118 in the described accompanying drawing.

Because providing in order to connection, the hole opening provide vision, audition or tactile feedback reaction (for example to use any well-known testing agency, such as but not limited to electric device, magnetic devices, pressure apparatus, capacitive means, induction installation etc.) device indicate and successfully penetrate characteristics tissue (for example epidural space), must form described opening described device being produced minimum disadvantageous position.In other words, because described actuator vibrates with altofrequency, all produce the different displacements of standing wave qualification along the each point of described actuator.In Figure 17, displacement diagram G1 represents standing wave, and described standing wave has the length travel at the some place of the Langevin actuator length of operation down along 38kHz.By displacement diagram G1 as seen, there are two nodes with nearly zero shift in the ad-hoc location of described standing wave.Therefore, two nodes on the Langevin actuator LT (" zero node " ZN) position is defined as along the length-specific of described Langevin actuator.In particular design shown in Figure 17, the node on the standing wave is with zero node or have the position consistency of Langevin actuator LT least displacement.Zero position of node on Langevin actuator LT is positioned at the back fixation piece proximal end face (not shown) of relative distal face 121.Line ZN limits the physical location of other zero nodes, when the second zero nodes of standing wave are formed in the Langevin actuator LT among the side opening SP relative displacement figure G1, should be positioned at described other zero node places, preferably is positioned at the center.Under situation shown in Figure 17, side opening SP is formed at horn 110 places of Langevin actuator LT, yet the hole opening might not only limit to this.The hole opening can be placed on along actuator Anywhere, but preferred zero node location.

In a more preferred embodiment, Figure 17 a describes the side opening SP position of penetrating member hub 525 0 node ZN.In the present embodiment, design length comprises needle length and the actuator length that reaches hollow needle 130 0 node ZN, also comprises the length of penetrating member hub 525.Side opening SP can be placed on along hollow needle 130 Anywhere, but the zero node location of preferred penetrating member hub 525.

In Figure 18 a, when the hole opening is positioned at along the zero node location center of horn 110, show common side opening configuration 700 of the present invention with side opening SP.Zero node place also forms braced wing 111, in order to assist the clinicist to hold and to stablize described apparatus.

In the seventh embodiment of the invention shown in Figure 18 b, first side opening configuration 700a has the passage that allows liquid, gas or other materials pass through, and comprise continuous path, this continuous path passes through the distal openings (not shown) by hole 126 via proximal openings 124, extend through hollow needle 130, stop at the far-end 130a of open hollow pin.In described the 7th embodiment, this passage is communicated with the side opening SP of 126 positions along the hole.Side opening SP preferably is positioned at the position along this actuator, forms first side opening configuration 700a, start described apparatus vibration after, first side opening configuration 700a is as zero node.

Perhaps, shown in the eighth embodiment of the invention of Figure 18 c, second side opening configuration 700b has the passage that allows liquid, gas or other materials pass through, and comprises the continuous path that is positioned on the hollow needle 130 penetrating member hubs 525.In described the 8th embodiment, described passage is communicated with side opening SP along penetrating member hub 525 positions.Side opening SP preferably is positioned at along the position of whole length (actuator and penetrating member), forms second side opening configuration 700b, start described apparatus vibration after, second side opening configuration 700b is as zero node.At the second side opening SP that is positioned on the described actuator, indicator, for example light emitting diode 1026, can connect electronic installation, so that show the vision drag losses.

Perhaps, shown in the eighth embodiment of the invention of Figure 18 d, second side opening SP configuration 700c has the aperture 126a that allows liquid, gas or other materials pass through, and aperture 126a is positioned at the zero node ZN place that travels to and fro between hollow needle 130.

In ninth embodiment of the invention as shown in figure 19, provide a kind of force feedback instrument 800 that subtracts.Only for example, instrument 800 comprises the instrument that haptic feedback response is provided by traditional lower resistance entry needle PA3, and traditional lower resistance entry needle PA3 has band plunger or air bag (for example elastomer device) or forms the biasing element 11 of pressure with any other device of detection or gaging pressure variation.This apparatus (only for example) Rule cone joint, external screw thread/female adapter, nipple coupling opening position preferably are positioned at the side opening SP of (preferably being positioned at the center) zero node location.Instrument 800 also comprises the indicator that is communicated with actuator 700, such as but not limited to audible indicator, tactile indicators or visual detector (for example venting, optics etc.).

In the most preferred embodiment of the present invention shown in Figure 19 a, subtract on the hollow needle 130 that force feedback instrument 800 is positioned at penetrating member hub 525 0 node ZN places.

In described another embodiment of Figure 19 b, the probability pressure transducer feedback system 1020 that comprises compact pumping mechanism is equipped with pressure or the flow transducer and the container 1021 that is installed on the bottom 1024 that metering removes Fluid Volume.Pump is full of saline, and by connect the side opening SP of this penetrating member via the flexible pipe 1022 of connection fittings 1023.When detecting non-resistance (LOR), electronic control system will be closed switch and the indicator that is positioned on this actuator side opening SP, light emitting diode (LED) (not shown) for example, and open the drag losses indication.At this moment, this electronic control system can be closed this actuator, and therefore, travelling forward stops.In other embodiments, except that visual signal, audible signal " beeping sound " can be incorporated described pumping system into.

Only for example, below be to use illustrative methods of the present invention, thus, the clinicist uses the present invention to carry out epidural surgery.When carrying out epidural surgery, the clinicist at first is full of fluid with syringe PA3, for example saline solution or air.Then, the clinicist inserts the front portion 9 of syringe the side opening SP of actuator 700b.After electricity started this actuator, the clinicist held actuator 700b with the first in command, makes the far-end 130a of hollow needle push down the patient back simultaneously.The clinicist continues to provide power forward, and the bias force of relative biasing element 11 also is provided simultaneously, and advances hollow needle 130.Under the effect of continuous power forward, this hollow needle puncture supraspinal ligament, interspinal ligaments and ligamenta flava (for example, seeing Fig. 7).After piercing through ligamenta flava, the far-end 130a of pin enters epidural space, and at this moment, biasing element 11 to far-end 130a opening pressure occurs and descends.Pressure descends and to make solution from the ejection of far-end 130a opening, the lasting biasing of biasing element 11 and brine volume loss cause together the lower resistance (LOR) of relative clinicist's thumb and biasing element 11 obviously can confirm move.When mobile, the clinicist confirms rapidly successfully to arrive epidural space described biasing element, and stops the power forward of this actuator rapidly because of resistance lacks.In addition, because the startup of this actuator causes pin 130 vibrations, the clinicist does not need to provide so high penetration power, and can react rapidly, so that stop before described pin surpasses epidural space.

Should also be noted that in addition within broad range of the present invention, comprise syringe or other mechanisms that automatic biasing is provided, make enter (for example) epidural space before, the clinicist does not need biasing element 11 is applied bias force.Especially, when pin passes supraspinal ligament, interspinal ligaments and ligamenta flava, automatically bias force (for example, by spring, elastomer or any other well-known biasing mechanism, implement such as but not limited to the described biasing mechanism of No. the 2007/0142766th, U.S. Patent Publication case people such as () Sundar) keep equal resistance.After entering epidural space, bias force is no longer resisted, can prove that to the clinicist bias force is no longer resisted in every way, but be not limited to that biasing element moves or any other vision indication, audible indication or sense of touch indication by any well-known testing agency's (such as but not limited to electric device, magnetic devices, pressure apparatus, capacitive means, induction installation etc.).For example, the pressure signal of indication solution resistance loss cuts off the power supply of drive actuator (for example piezoelectric element, voice coil loudspeaker voice coil, solenoid etc.) automatically.

Although feedback device coupling side opening SP, the present invention is not limited in feedback device.All can the be coupled hole site of this actuator of any apparatus, or best side opening SP position are although described apparatus only provides or remove the apparatus (for example conventional syringe) of liquid, gas or other materials.

Although the above embodiment of the present invention relates to a kind of hand-held medical apparatus that has the vibration penetrating member and use foregoing Langevin actuator, cymbals type actuator or APA to activate, the present invention is not limited in described actuator.Usually, comprise actuator and also comprise the motor of any kind of fixed block of the piezoelectric that is coupled or voice coil motor or solenoid or any other translational motion device all belong to the spirit and scope of the present invention.In addition, if described actuator comprises the fixed block that is coupled to piezoelectric, described actuator with geometry also belongs to the spirit and scope of the present invention, and described actuator amplifies the motion towards certain direction after actuating, makes it surpass the maximum stress of described piezoelectric.

Figure 20 a describes alternate embodiment 900 of the present invention, and alternate embodiment 900 uses voice coil loudspeaker voice coil as drive actuator, but not piezoelectric element.Voice coil actuator (being also referred to as " voice coil motor ") produces low frequency and moves back and forth.The bandwidth of voice coil loudspeaker voice coil is about 10-60Hz, and displacement reaches 10mm, depends on the alternating voltage that applies.Especially, when inductance coil 902 applied alternating current, the result was the Lorentz force that the cross product function between the magnetic vector of the sense of current of inductance coil 902 and magnetic part 904 limits direction.Described power moves reciprocatingly magnetic 904 relative coil arms 906, and body 910 is with coil arm 906 fix in position.Owing to be fixed on the magnetic part 904 on the driving tube 912, driving tube 912 is given extension 914 with described Motion Transmission, and extension 914 passes motion to penetrating member 20 conversely.

The first junction point 916a is fixed to the far-end of coil arm 906 on the body 910; The second junction point 916b is fixed to the near-end of coil arm 906 on the body 910.Inductance coil can be made up of difference configuration, include but not limited to form by single line which floor, constitute by circle or other geometries not collinear which floor.In first embodiment of the inductance coil shown in Figure 20 a, by with class rotation and spiral way radially (around the described coil arm) wrap wire form the ground floor conductor wire, turn over forms an adjacent previous wire turn and is positioned at the wire turn of described coil arm first below vertically.After the predetermined number of turn, first wire turn by the overlapping second line layer on the last wire turn of ground floor, on ground floor, form additional layer along the radially continuation wrap wire identical simultaneously with ground floor, has second identical with the ground floor number of turn at least helix thereby form, the adjacent previous wire turn of each wire turn, and opposite with the formation direction of ground floor vertically.In the present embodiment, can be by first wire turn of overlapping each additional lines layer on the last wire turn of last layer, increase additional layer along the radially continuation wrap wire identical simultaneously with preceding one deck, has identical with the last layer number of turn at least extra spiral thereby form, the adjacent previous wire turn of each wire turn, and opposite with the formation direction of last layer vertically.

Figure 20 b shows alternative voice coil loudspeaker voice coil embodiment 900b.Especially, in described alternate embodiment, the position of switched magnetic spare 904 and inductance coil 902.In other words, described inductance coil twines and connects driving tube 912, and magnetic part 904 is along the outer radius setting of coil arm 906.

Electric signal is applied to conduct electricity link position 918 and 920, and is the reason that forms the alternating direction Lorentz force, and described Lorentz force makes inductance coil 902 and extension 914 move back and forth along the described apparatus longitudinal axis.Described inductance coil directly contacts the described driving tube of present embodiment.

Figure 20 c describes another embodiment of the present invention, and this embodiment uses the voice coil loudspeaker voice coil actuating mechanism, and have with Figure 20 a and 20b in the different configuration of used embodiment.For example, in this alternate embodiment, replace the voice coil loudspeaker voice coil actuating mechanism with the twin coil actuating mechanism, described displaced result is that the magnetic part 904 of described voice coil loudspeaker voice coil replaces with second inductance coil 922.In other words, second inductance coil 922 twines and connects driving tube 912, and as first preferred embodiment, first inductance coil 902 is along the outer radius setting of coil arm 906.In first embodiment of Figure 20 c configuration, interior loop 922 conduct direct current electric currents, exterior loop conduction alternating current.In an alternate embodiment, described interior loop conduction alternating current, described exterior loop conduct direct current electric current, in other embodiments, described interior loop and described exterior loop are all conducted alternating current.

In all described voice coil actuator configurations, spring can be used for limiting and controlling some dynamic aspect of penetrating member 20.Figure 20 d describe to use the another kind of modification of the tenth embodiment voice coil actuator mechanism of spring, even with the medical instrument of electromagnetic actuators 1000.As other voice coil loudspeaker voice coils embodiment that uses coil, cause the basic driver principle by the solenoid 1002 inner time-varying magnetic fields that produce, solenoid 1002 acts on one group of very strong permanent magnet.Magnet 1004 and whole penetrating member 20 assemblies vibrate back and forth by solenoid 1002.Spring 1014 (for example spring shown in Figure 20 d) absorbed and releases energy in each in cycle, thereby amplified the visible vibration in penetrating member 20 places.The resonance characteristics of can select by Magnet, coil turn, axoplasm amount and spring rate in the solenoid being optimized described apparatus.

From the above description as seen, should be appreciated that, the invention provides the obvious benefit that is better than the traditional medical apparatus.The configuration of above-mentioned actuating device, the embodiment that for example comprises Langevin actuator, cymbals type actuator or APA, by make described sharp-pointed penetrating member or pin reach this quefrency (make bone biopsy, epidural catheter insert or operations such as intravascular injection in the required power minimizing of penetrate tissue) make and be suitable for using piezoelectric actuated in the medical apparatus and instruments.The electric signal control that the electrical couplings feedback system inspires can provide the height vibration rate that undergos surgery to activate capacity, penetration depth control, dump (reaction than the people is faster) and low pull strength.Only for example, Figure 21 describes a kind of dump configuration.Pressure transducer PT monitoring penetrating member 20 or the fluidic pressure that is communicated with tissue by the present invention.Although penetrating member 20 penetrate tissues, the pressure that pressure transducer PT detects is higher, and switch S is closed usually.In case pressure descends (last layer tissue is passed in indication), pressure transducer PT signal will be opened switch S, thereby cuts off the power supply of described medical instrument.In addition, visual detector, audible indicator or tactile indicators activate immediately, and alarm operation person's penetrating member 20 passes completely through, and dump.In broad range of the present invention, comprise various dump configurations, comprise solid-state switching and/or digital control.

Another kind of dump actuating unit detects travelling forward of biasing element 11 mentioned above.Especially, in case penetrating member 20 passes last layer tissue, the pressure of biasing element 11 discharges, the incremental motion of sensor biasing element 11 in body 10, and described pick off is cut-off switch S immediately, thereby cuts off power supply of the present invention.

In addition, owing to after extracting tissue, be necessary to regain ex vivo described penetrating member in the bone biopsy, the feedback control of electronic installation can be vibrated described apparatus in the mode that reduces power simultaneously.

Since exemplary embodiment of the present invention is also described in demonstration in detail, various modifications of being done and improvement are apparent concerning the those skilled in the art.Although the foregoing description may relate to skin, sclerotin, vein and the ligament that penetrates as exemplary biological tissue, the present invention can guarantee to want usually the similar effect of its hetero-organization of penetrating body undoubtedly.For example, multiple other instruments (as laparoscopic instrument, chamber drainage catheter external member and the neonate lancet of central venous catheter introducer, band associated needle) and multiple operation (such as insulin administration and the test of percutaneous glucose) are arranged, only as example, this paper disclosed embodiment that drives sharp-pointed part comprising sound wave or ultrasound wave can be used for the minimum tinting strength, tinting power tissue of accurately wearing out or puncture.Correspondingly, the spirit and scope of the present invention are carried out extensive and restricted explanation by claims only, can't help above-mentioned description to make an explanation.

Reference label

The static pin puncture force of A curve

B immersion needle puncture force curve

The G1 displacement diagram

LT Langevin actuator (being also referred to as the Langevin pick off)

PA1 tradition biopsy needle

PA2 tradition epidural needle

The PA3 conventional syringe

The PT pressure transducer

The S switch

The SP side opening

ZN zero node

1 sleeve pipe

1 ' boot proximal end

2 stylets

3 distal tip

4 stylet wedge angle faces

5 Tuohy pins

6 Tuohy bent tips

7 sharp openings

9 front portions

10 tubular bodies

11 biasing elements

12 plungers

Stylet in 14

15 trocar sheath needle tubings

16 APA pins

The 16b alternate embodiment

20 penetrating members

100 Langevin actuators

110 horns

111 braced wings

112 back fixation pieces

114 piezoelectric elements

The 114b electric conductor

115 sterilization covers

116 bolts

117 batteries and inverter chamber

118 handles

120 sealing members

121 distal faces

122 distal openings

123 Rule conical heads

124 proximal openings

126 holes

The short hole of 126a

128 connection fittings

129 conduits

130 hollow needles

130a hollow needle far-end

130b hollow needle near-end

132 plunger handles

134 plunger axis

134a plunger axis near-end

134b plunger axis far-end

136 plunger seals

Die needle handle in 142

Die needle shaft in 144

Die needle point in 146

148 trocar connection fittings

150 trocar sheath needle bodies

152 distal cannula pin openings

154 trocar tips far away

200 penetrate introducer

The 202b more preferred embodiment

The 202c most preferred embodiment

201 supporting introducers

202 catheter introducers

300 bone movable detecting apparatus

400 senior bone movable detecting apparatus

500 APA syringes

The 500b alternate embodiment

510 scale-up version piezo-activators (APA)

512 frameworks

512a framework near-end

512b framework far-end

513 penetrating members

513a penetrating member near-end

513b penetrating member distal tip

514 piezoelectrics

516 APA junction points

518 handles

521 handles distal openings

524 handle proximal openings

525 penetrating member hubs

526 APA holes

600 cymbals type syringes

The 600b alternate embodiment

610 cymbals type actuators

612 end caps

The 612a proximal end cap

The 612b distal end cap

626 cymbals type holes

616 cymbals type junction points

700 general side opening configurations

The configuration of 700a first side opening

The configuration of 700b second side opening

800 subtract the force feedback instrument

900 use the medical instrument of voice coil actuator

900b substitutes voice coil loudspeaker voice coil embodiment

902 inductance coils

904 magnetic parts

906 coil arms

910 bodies

912 driving tubes

914 extensions

916a first junction point

916b second junction point

918 first conduction link positions

920 second conduction link positions

922 second inductance coils

1000 use the medical instrument of electromagnetic actuators

1002 solenoids

1004 Magnet

1014 springs

1020 pressure feedback systems

1021 have the container of integration pump

1022 flexible pipes

1023 connection fittings

1024 bottoms

1025 on and off switch

1026 light emitting diodes

Claims (33)

1. medical apparatus and instruments that is used to penetrate biological tissue, described apparatus comprises:

Penetrating member, described penetrating member back and forth leave and enter described medical apparatus and instruments, to reduce to penetrate the required power of biological tissue;

Drive actuator, the described drive actuator described penetrating member that is coupled is so that convert electrical energy into reciprocating motion when energising;

Power cut-off device, described power cut-off device are used for making described medical apparatus and instruments outage after described penetrating member passes biological tissue.

2. medical apparatus and instruments according to claim 1, wherein said drive actuator comprises:

Have far-end and the actuator that is coupled to the described penetrating member of described far-end, described actuator comprises the first passage that extends to described far-end, described actuator also comprises at least one piezoelectric element, and described at least one piezoelectric element is used for converting electrical energy into oscillating movement when energising;

Described actuator also comprises second channel, and first end of described second channel is communicated with described first passage, and second end is positioned at the outer surface of described actuator;

When described at least one piezoelectric element was switched on, described actuator moved described far-end and described penetrating member, makes it do oscillating movement.

3. medical apparatus and instruments according to claim 2, wherein said at least one piezoelectric element are suitable for the certain frequency vibration, to produce the sinusoidal displacement of described penetrating member.

4. medical apparatus and instruments according to claim 2, wherein said first passage extends through described penetrating member, third channel extends through described at least one piezoelectric element, described first passage is aimed at described third channel, wherein said actuator also comprises the anchor with four-way, described four-way extends through described anchor along the longitudinal axis of described anchor, and described four-way is aimed at described first passage and described third channel, passes the continuous passage of described actuator with formation.

5. medical apparatus and instruments according to claim 2, wherein said first passage extends through the part of described penetrating member.

6. medical apparatus and instruments according to claim 1, wherein said penetrating member are that hypodermic needle, conduit insert one of them of pin, Tuohy pin, bone biopsy cannula pin, spinal needle, nerve block pin, trocar hand-hole and intervention radiation pin.

7. medical apparatus and instruments according to claim 2, wherein said actuator are the Langevin actuator.

8. medical apparatus and instruments according to claim 7, the described far-end of wherein said Langevin actuator limits antinodal points.

9. medical apparatus and instruments according to claim 1, the outer surface of wherein said actuator comprises side opening, described side opening is used for the fluid passage being provided or catheter channel in the described penetrating member being provided to described penetrating member.

10. medical apparatus and instruments according to claim 2, wherein the described second channel that is communicated with first passage radially extends from the longitudinal axis of described actuator, and places the place-centric that limits zero node.

11. medical apparatus and instruments according to claim 1, also comprise the liquid syringe that contains that is coupled to described actuator endoporus, the described liquid syringe that contains comprises the removable biasing element that is placed in one, passage fluid in wherein said biasing element and the described penetrating member is communicated with, when described penetrating member passed biological tissue, described biasing element provided indicator.

12. medical apparatus and instruments according to claim 1, the liquid syringe that contains that also comprises the pin connection fittings endoporus that is coupled to described medical apparatus and instruments, the described liquid syringe that contains comprises the removable plunger that is placed in one, passage fluid in wherein said plunger and the described penetrating member is communicated with, when described penetrating member passed biological tissue, described plunger provided indication.

13. medical apparatus and instruments according to claim 1 also comprises the lower resistance pumping system that is connected by interface with described actuator, described lower resistance pumping system comprises visual detector, and the described visual detector described penetrating member of indication automatically enters predetermined body region.

14. medical apparatus and instruments according to claim 13, wherein said visual detector comprises LED.

15. one of them that vision indication, audible indication or sense of touch that medical apparatus and instruments according to claim 12, wherein said plunger provide described penetrating member to pass biological tissue are indicated.

16. medical apparatus and instruments according to claim 12, wherein said plunger starts described power cut-off device.

17. medical apparatus and instruments according to claim 1, wherein pressure transducer detects the interior pressure of described passage of described penetrating member, and starts described power cut-off device.

18. medical apparatus and instruments according to claim 1, wherein said drive actuator comprises the voice coil loudspeaker voice coil that is coupled to described penetrating member, and described voice coil loudspeaker voice coil converts electrical energy into oscillating movement during energising.

19. medical apparatus and instruments according to claim 18, wherein said voice coil loudspeaker voice coil comprise the coil that twines permanent magnet and described penetrating member.

20. medical apparatus and instruments according to claim 19 also comprises the spring that is positioned at described coil and described permanent magnet opposite side.

21. medical apparatus and instruments according to claim 18, wherein said voice coil loudspeaker voice coil comprises the permanent magnet of winding around and described penetrating member.

22. medical apparatus and instruments according to claim 18, wherein said voice coil loudspeaker voice coil comprise a pair of ceoncentrically wound coil that twines described penetrating member.

23. medical apparatus and instruments according to claim 1, wherein said reciprocating type actuator are one of them of pneumatic actuator or fluid actuator.

24. medical apparatus and instruments according to claim 12, wherein said plunger are used for extracting material by described medical apparatus and instruments out from described live body.

25. a method that reduces to penetrate the required power of biological tissue, described method comprises:

By reciprocating type actuator the relative biological tissue of penetrating member is moved back and forth, described reciprocating type actuator converts electrical energy into reciprocating motion;

Detect described penetrating member and whether pass described biological tissue;

When described penetrating member passes described biological tissue, cut off the electric energy of described reciprocating type actuator automatically.

26. whether method according to claim 25, the described penetrating member of wherein said detection pass the step of described biological tissue be included in and contain mobile plunger in the liquid syringe, the interior passage fluid of described plunger and described penetrating member is communicated with.

27. method according to claim 26, wherein said plunger are coupled to the switch that electric energy is provided to described reciprocating type actuator.

28. method according to claim 25, the step whether described penetrating member of wherein said detection passes comprises pressure actuator, described pressure actuator is monitored the pressure in the described penetrating member passage, wherein said pressure actuator provides the output of gauge tap operation, and described switch provides electric energy to described reciprocating type actuator.

29. method according to claim 25, wherein said reciprocating type actuator is at least one piezoelectric element.

30. method according to claim 29, wherein said reciprocating type actuator is the Langevin actuator.

31. method according to claim 30, wherein said reciprocating type actuator is a voice coil loudspeaker voice coil.

32. method according to claim 30, wherein said reciprocating type actuator are one of them of pneumatic actuator and fluid actuator.

33., also comprise the step of using described plunger to extract material out from live body by described medical apparatus and instruments according to the described method of claim 37.

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