GB2367895A - Needle location system for use with ultrasound imager - Google Patents

Needle location system for use with ultrasound imager Download PDF

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Publication number
GB2367895A
GB2367895A GB0029520A GB0029520A GB2367895A GB 2367895 A GB2367895 A GB 2367895A GB 0029520 A GB0029520 A GB 0029520A GB 0029520 A GB0029520 A GB 0029520A GB 2367895 A GB2367895 A GB 2367895A
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Prior art keywords
needle
crystal
stylet
tip
vibrator
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Richard Miles
James M Smart
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    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3403Needle locating or guiding means
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B17/00Surgical instruments, devices or methods, e.g. tourniquets
    • A61B17/34Trocars; Puncturing needles
    • A61B17/3403Needle locating or guiding means
    • A61B2017/3413Needle locating or guiding means guided by ultrasound
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00Instruments, implements or accessories specially adapted for surgery or diagnosis and not covered by any of the groups A61B1/00 - A61B50/00, e.g. for luxation treatment or for protecting wound edges
    • A61B90/39Markers, e.g. radio-opaque or breast lesions markers
    • A61B2090/3925Markers, e.g. radio-opaque or breast lesions markers ultrasonic
    • A61B2090/3929Active markers

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  • Health & Medical Sciences (AREA)
  • Surgery (AREA)
  • Life Sciences & Earth Sciences (AREA)
  • Biomedical Technology (AREA)
  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
  • Engineering & Computer Science (AREA)
  • Pathology (AREA)
  • Heart & Thoracic Surgery (AREA)
  • Medical Informatics (AREA)
  • Molecular Biology (AREA)
  • Animal Behavior & Ethology (AREA)
  • General Health & Medical Sciences (AREA)
  • Public Health (AREA)
  • Veterinary Medicine (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

The system comprises a piezoelectric driver unit ,e, attached to the base of a needle, a, so that in use the piezoelectric driver imparts a longitudinal vibration to the needle enabling it to be seen by a conventional medical ultrasound imaging system. The system is designed for medical procedures such as biopsies and enables the needle to be more clearly seen on an ultrasound imaging system.

Description

TITLE: Medical needle system for use in ultrasound imaging and ultrasound guided biopsy and method of enhancing the visibility of such a need ! c to ultrasound.
This invention relates to a medical needle system and, in particular, to a device to enhance the visibility of the needle system when using ultrasound guidance for biopsy, aspiration, vascular access or related procedures.
BACKGROUND OF THE INVENTION Medical ultrasound imaging guidance of needles/biopsy needles is a commonly used technique. It is desirable to be able to visualise the tissue area of interest and the needle and, in particular the needle tip. However, the visualisation of the needle itself within tissues can be problematic.
A number of methods of enhancing needle visibility have been proposed and some are commercially available these include the use of biopsy guides to help maintain alignment of the needle within the scan beam which is a practical arrangement for certain procedures and may allow fairly accurate needle placement even if the needle remains only poorly visible. Needle guides can be cumbersome and needle tip visualisation may be problematic.
. Many biopsy needles have angled or roughened needle tips, which may increase signal return from the needle to some degree though this advantage is lost in echogenic tissues and of less value at depth (e. g. , the Echotip from W. Cook and Co).
Signal return and therefore needle visibility reduces dramatically with increasing needle angle with respect to the insonnating ultrasound beam.
Active imaging systems as detailed in US Patents 3, 556, 079 ; 4, 249, 539 ; 4, 431, 006 ; 4, 407, 294 ; 4, 428, 379 and GB Patent GB-A-2, 157, 828 ; employ various configurations of ultrasonic transmitter/receiver either placed at the proximal end of the needle or distally at the tip which in co-operation with the scanhead/imaging system allows either direct or computed analysis of the position of the needle and represents it on the final image. Disadvantages of these techniques include construction of miniaturised transmitters, which is expensive, and the requirement for compatibility between the imaging system and the needle.
Using the principle of Doppler shift a signal can be ascribed to those objects that are moving within the body and these signals can be displayed as a colour signature on the otherwise greyscale image. Color ultrasound imaging systems are sensitive to the relatively small motion of blood in arteries, to displacements measured in microns.
Typical state of the art systems are able to show velocity in the 1 to 100 centimeters per second (cm/sec) or more range on a color image display. In order to accomplish this, the first and second imaging pulses are produced every 80 to 330 microseconds (. mu. sec) depending on the scale of the velocity to be detected. If a 5 cm/sec velocity is detected where the sampling interval of the imaging pulses is 118/. mu. sec, the displacement of the point is 5 cm/sec times I 1 81. mu. sec, or approximately 6 microns.
Therefore, small vibratory motions, on the order of microns, are detectable by color flow imaging.
The journal of Ultrasound in medicine. Vol. 9, 243-45 (1990) reported improved
v visibility of the needle by moving or oscillating it by hand while employing the si 1 11) Doppler mode. This crude technique tends to cause a wide flare of colour signature in the region of the needle and is therefore of limited value. Applications using the principle of vibration to improve needle visibility include a
commercially available product ColorMark ; EchoCath, Princeton NJ. The related US patent is 5, 343. 865 sept 6 1994. This device is attached to the hub of the needle and provides multiplanar but predominantly flexural oscillation to the needle. It comprises a mechanical motion mechanism controllably activated to periodically move through preselected mechanical positions.
A mechanical coupling element is mounted on the mechanical motion mechanism and coupled to an interventional device for transmitting mechanical energy as flexural waves that propagate along the length of the interventional device.
In practice significant damping of the vibration occurs within the tissues which considerably reduces the useful oscillation at the needle tip.
US patent 5,095, 910 Mar 17 1992 to Jeffry E Powers (European patent EP 0,453, 251 A 1) describes a system for imaging a biopsy needle with ultrasound, wherein the needle causes a Doppler response in a color ultrasonic imaging system through motion produced by the reciprocation of the needle tip. The'910 patent describes a biopsy needle which includes a hollow cannula that carries a removable stylet and describes a method of oscillating the inner, solid stylet using a solenoid as the motive source. The arrangement allowed the inner stylet to lie flush with outer needle at its furthest extent of travel. The method employed frequencies preferentially under 100 Hz The range of movement of the stylet was stated to he generally around one
millimetre. Problems included image degradation by the Moire pattern effects. I Tadation by the Mol tem effects.
In terms of additional background, some years ago physicians noticed color images appearing when needles were advanced through tissue (McNamara, M. P. , AJR 1 52, p. 1123 (1989), Kurohiji et al., J. Ultrasound Med 9 : pp. 243-245, 1990). Kimme Smith et al., in a paper given at the ARUM, in February 1991 (see abstract in Journal of Ultrasound in Medicine, Volume 10, Number 3, p. 64) described making a needle visible on a colorflow imaging system by using a 400 Hz buzzer, an extension of the previous observations. The impression given in the Kimme-Smith article is that the buzzer acts in a reciprocating motion in the same manner as is done by hand, although the article is not clear on what exactly was done. The authors do not report consistent visualization using their method.
DESCRIPTION OF THE INVENTION In accordance with the present invention an apparatus and method are presented for ultrasonically imaging a medical needle system. The present invention is advantageous as compared with other aforementioned techniques in that active transponders are not employed. System integration is not required ; the present invention can be used with all ultrasound imaging apparatus with colour Doppler facility.
The present invention is advantageous as compared with other mechanically oscillated needle systems in that the invention employs a piezo-electric bimorph strip as the motive source, which overcomes the disadvantages of a heavy solenoid at the needle hub. Commercially available Piezo electric crystals are ceramics of lead zirconate and lead titanate which posses the property to deform when exposed to an electric field.
Piezoelectric crystals are used in a wide range of applications. Generally the amount of deformity of the crystal is small though greater displacements can be achieved by stacking a number of crystals or by using a laminate of two ceramics with different characteristics as a himorph strip. The maximum displacement of a 25mm long bimorph strip is 300 micrometres at full voltage. Satisfactory visualisation of the needle can be achieved with considerably smaller oscillations.
In this present embodiment a piezoelectric bimorph strip is connected to a voltage source/signal generator. The bimorph strip is anchored within a frame or housing thus upon application of an alternating voltage the crystal is induced to flex. The free edge of the crystal is coupled to the stylet of a two part co-axial needle. The outer part of the needle is affixed, in alignment, to the frame, housing Flexing of the bimorph strip causes reciprocation of stylet. The direction of this oscillation is predominantly in the longitudinal plane of the needle. The tip of the stylet, which in standard biopsy needle protrudes slightly from the outer cannula is therefore directly reciprocated.
This results in colour signal preferentially at the tip of the needle. This is of advantage as visualisation of the needle tip is the most critical factor in ultrasound guided percutaneous procedures. Visualisation of the shaft of the needle occurs as a result of flexural waves and lateral vibrations. There is an important damping effect of body tissues upon these flexural waves which significantly reduces visualisation of the needle shaft beyond a few centimetres. However, the direct reciprocation of the stylet ensures transmission of vibration to the tip of the needle thus improving visibility of the needle tip with respect to the shaft. (see Figs 7 & 8 appendix A, The effect of high frequency oscillation on needle visibility using colour Doppler J Smart, R Miles) In a preferred embodiment this method of oscillating a needle would be incorporated within an automated biopsy gun such that the needle tip could be guided to the target.
The gun would then be fired advancing sequentially a notched stylet followed by the outer cannula to obtain a sample of the tissue of interest.
In another embodiment the device could be incorporated into a housing to allow oscillation of one or two part needles for accurate placement of a needle within a tissue structure or vessel In a preferred embodiment the frequency range, which is under optimisation, is likely to be greater than 100Hz negating the deleterious effect of Moire patterns.
A specific embodiment of the invention will now be described with reference to the accompanying drawings in which: Figure 1 Shows from the side the biopsy needle attached to a body or handle which houses the piezo electric dnver unit and would, in a preferred embodiment, also house the spring powered biopsy mechanism.
Figure 2 Shows from above, the biopsy needle and piezo electric driver unit.
Figure 3 Shows the needle enhancement system in operation demonstrating the needle being directed toward a tissue mass of interest. Both the needle and the mass are, at all times, within the scan field of the diagnostic ultrasound apparatus-operating in colour Doppler mode.
Referring to figures ! and 2 The present invention is composed of a co-axial two-part needle adapted for insertion into body tissues. The hub (f) of the inner stylet (a) is coupled, detachably or permanently, to a piezo-electric bimorph crystal (e). The base of the bimorph crystal is firmly fixed to the body of the device (d). The outer needle (c) is also attached to the body of the device thus flexion of the bimorph crystal directly reciprocates the stylet along its axis.
In the preferred embodiment the stylet tip (a) protrudes slightly from the outer needle (b) as is the usual arrangement of a cutting biopsy needle In the present invention the crystal can flex by at most 0. 45mm when using a piezo electric bimorph 30 mm in length. In fact with the mass of the attached stylet the reciprocation is considerably less.
Referring to figure to figure 3 The piezo electric bimorph crystal is induced to flex and thus reciprocate the stylet upon application, via the fine connecting cable (g), of an alternating voltage provided by a suitable signal generator (1) and amplification system (k). Miniaturisation of the power source is envisaged such that the device is entirely self contained at the needle hub with no connecting cable.
The vibrations induced at the tip of the needle are detected by the scan head (i) and processed by the diagnostic ultrasound apparatus (j) operating in colour Doppler mode and are displayed as a colour signal on the scan screen thus allowing accurate visualisation of the needle tip at all times.
In a preferred embodiment the handle or body of the device would house a spring powered biopsy mechanism. This would allow the needle tip to be guided to the area of interest (h) then the biopsy gun could be triggered and a tissue core biopsy taken by forward advancement of the inner stylet and subsequent forward throw of the outer needle over the stylet.
HE EFFECT OF HIGH FREQUENCY OSCILLATIONON NEEDLE ". I 1 9 1 1 ISIBILITY USING COLOUR DOPPLER : AWORK IN PROGRESS Introduction : Ultrasound guided percutaneous biopsy and drainage procedures continue to have an important place in clinical radiology. The main limiting factor remains the visibility of the needle tip. Equipment advances have helped to reduce this problem, but there are still a significant number of cases particularly for deep biopsies or localisation of small lesions where needle tip visibility is impaired. We have investigated a method of enhancing needle tip visibility by rapid oscillation of a needle or its inner stylet to produce a localised enhancement on colour flow at deep levels.
Materials and Methods: The system that we envisaged would allow for needle tip localisation at depth, and would ideally be adaptable to different types of needle and ultrasound equipment.
We theorised that rapid linear movement of the stylet of a two-part needle, whilst minimising lateral vibration within the outer needle, potentially could produce localised colour signal at the needle tip.
The most effective mechanism for driving the stylet was found to be a piezoelectric bimorph crystal (Philips PXE parallel bimorph 25 x 12 x 0.6mm). This was housed in a frame, which also acted as the support for a two-part biopsy needle (Fig 1). The inner stylet was attached to the crystal, and the crystal coupled to a variable signal generator and power supply, allowing different amplifications and frequencies to be passed through the system.
The stylet is moved fractionally (150) im) in a forward and backward linear motion by the changing shape of the crystal.
Two types of phantom were utilised. Turkey/chicken breast, plus gelatine based phantoms (as shown) adjusted to produce tissue-like texture and to be near iso-echoic with the needle. Targets were included in the phantom.
Experiments were performed to establish the most suitable oscillation frequency and power settings, in addition to assessing the systems response to different angles and depths. Images were acquired on standard colour doppler settings using an ATL HDI 5000 with a 5-2 curvilinear array.
Only adjustments to the colour gain setting were required to optimise the images.
Results : As displayed in the accompanying images (Fig 3-8) the system is effective in producing localised colour signal around the tip of a 2 part needle. There is little drop off at depth, with good visualisation to 10 cm (Fig 8). Superficial needle positioning does show some increased flare though adjustment of colour gain counters this (Fig 6). Colour signal is not demonstrably dependent upon angle of insonnation.
A wide range of oscillation frequencies produced good colour signal though better localisation occurred with frequencies between 450 and 1000 Hz.
Optimum colour signal was seen at harmonics of the electrical and mechanical resonance of the system.
Colour was not completely limited to the stylet tip as postulated for a two part needle. Usually colour was present along the shaft, but with prominence at the tip. At greater depths lateral vibrations of the shaft appear
to be damped, though colour signal at the tip remains, presumably from the longitudinal oscillation of the stylet (Fig 7 & 8).
Fig 1. Expenmemal system showing the oseUhung devjce wth Flg. 2 Schemauc dharmm of oscillating deice. dX pieMo tlecuic bimorph clyslal hoted n a h a and dlrec8y coupled to the mner Mylet of a rwo pan 18g btopsy aetdie.
Fig 3 Demnsmon of effem on viwgmwn of thetixdle, rud FgA lin3geof tbe stunetcedle audttreetas5g3witbtbe in up asu appfoaehes a tuget th the de MtCbed on. dewm s., tdied off.
FtR-5 Locallsed colour flow seen around the Medle and tip"t Hg. 6 Localise colour flow un td the rbile d tip at 7cma. Dd 65 degrees. I 6 < ttHm 5cmata 45 degree e.
Fig. 7 EHuve localisation of the oeecUe tipaiScmandat 60 Rg. 8 Effecttve locahMt) oDof theneed ! eatiOcmaodan degrees angle of 75 degrees.
Discussion : A number of techniques for enhancing needle visibility have been developed. Needles with an roughened surface or echogenic tip are available'. 2. Incorporation of an acoustic transponder into a needle or stylet ensures its visibility3, but requires coupling of the software of the ultrasound machine and device. Adjustments in technique, such as use of the'pump manoeuvre'have been described'. Biopsy guides are often successful though they can be cumbersome and tissues that are isoechoic to the needle or that cause the needle to curve limit their application. ;
The use of colour flow to improve imaging of the moving needle is well recognised. Needle vibration using an electronic device attached to the shaft (ColorMark ; EchoCath, Princeton, NJ) is effective in superficial tissues but limited transmission of vibration to the tip at depths greater than 5cm has been reported'. Oscillation of an air column through a hollow stylet has also been studied, and demonstrates greater value at depth, but its practical use appears to be limited due to occlusion of the stylet by tissue or phantom material.
We have developed an experimental system that shows potential to reduce or abolish the limitations encountered with other systems. Reproducible colour signal is localised to the needle tip using high frequency oscillation. Little if any adjustment in machine settings is required to achieve this.
I The device is cheap, light and adaptable and because of the fractional needle movement we feel that additional tissue trauma is unlikely to be an issue. We would envisage that the I device could readily be incorporated within a biopsy gun. Such a system could aid needle visualisation, reduce procedure time and improve accuracy. fMtntX-)) 1 HKIV 1. B.. gM. M. ImTA. S & $ 199D. 17fO) 867-ML 4 5 ! FR. NttdtMBML. CaBUM*Beedit* < ne < ) < tM'iMhM < ioppktmttfMM < MtbFe)) MMiM tMfm 3. B~M. Mtt4tTb51her Tlep, prwvt==. di. t . US > ibXp~Rc s Iyl950ul7 3) 55711 iF @ &verbar; = &verbar; &verbar; &verbar; &verbar; SR, NL GoNersS Uors~vZisdercosJR8t 4l7pkr ~ otty=2afl. 1573775 R &verbar; E ifi &verbar; 5j g g &verbar; i &verbar; i u 6 rvu~nu FPCsY5rcv6DO. D~27v1rol kerche7tprtcolowdo f=U5 R=0371995, 1j5 570. 37'i fi &verbar; s &verbar; &verbar; i i i i z

Claims (6)

Claims What is claimed is: A vibrator mechanism apparatus for use with an ultrasound imaging system including signal processing means for detecting motion (colour flow Doppler) and including means for displaying a structural image of an interior region of a body in which said motion is represented, said vibrator attached to an interventional medical device employed by a user of said imaging system to accurately place and move said interventional device within the interior of said body, comprising:
1. A vibrator device comprising a piezo-electric bimorph crystal incorporated within a housing with the base of said bimorph crystal affixed to the housing. The remainder of the crystal is uninhibited and on application of a suitable voltage is able to flex. The free end of the bimorph crystal is detachably attached to the hub of a medical interventional needle either co axial or single part. Whereby on application of suitable alternating voltage the piezo-electric crystal flexes and therefore fractionally oscillates the needle predominately in the longitudinal direction.
2. The vibrator device according to claim 1 whereby the motive force is provided by a piezo-electric crystal stack so arranged as to reciprocate a needle or needle system predominantly in the longitudinal plane.
3. The vibrator device according to claim 1 or claim 2 further comprising of a co-axial needle system in which the motive force is detachably attached to the hub of the inner stylet predominantly oscillating the inner stylet in the longitudinal direction with respect to the outer cannula.
4. The vibrator device according to claim 3 wherein the tip of the stylet remains just distal to the tip of the outer cannula throughout its cycle of oscillation.
5. The vibrator device according to claim 1 to 4 wherein the needle or inner stylet of a co-axial needle is reciprocated at less than 2000 Hertz.
6. The vibrator device according to claim 1 to 5 wherein said motive means is coupled to timing and control means for optimising the Doppler signal interrogation by the ultrasonic imaging system.
GB0029520A 2000-06-05 2000-12-04 Needle location system for use with ultrasound imager Withdrawn GB2367895A (en)

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GBGB0013645.7A GB0013645D0 (en) 2000-06-05 2000-06-05 Medical needle system for use in ultrasound imaging and ultrasound guided biopsy and method of enhancing the visibility of such a needle to ultrasound

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Cited By (6)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1543854A1 (en) * 2003-12-16 2005-06-22 Novo Nordisk A/S Vibrating injection needle and method for detecting the presence of medicament therein
WO2012066510A1 (en) * 2010-11-19 2012-05-24 Xavant Technology (Pty) Limited Vibrating needle adjustment device
WO2014118376A1 (en) * 2013-02-01 2014-08-07 Olberon Medical Innovation Sas Needle location device
CN105377144A (en) * 2013-03-15 2016-03-02 敦提大学校董事会 Medical apparatus and its visualisation
GB2566532A (en) * 2017-09-18 2019-03-20 Active Needle Tech Ltd Vibrating probe
US11369296B2 (en) 2011-02-01 2022-06-28 Olberon Medical Innovation Sas Needle holder

Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4431006A (en) * 1982-01-07 1984-02-14 Technicare Corporation Passive ultrasound needle probe locator
US5967991A (en) * 1996-12-03 1999-10-19 Echocath, Inc. Drive apparatus for an interventional medical device used in an ultrasonic imaging system

Patent Citations (2)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4431006A (en) * 1982-01-07 1984-02-14 Technicare Corporation Passive ultrasound needle probe locator
US5967991A (en) * 1996-12-03 1999-10-19 Echocath, Inc. Drive apparatus for an interventional medical device used in an ultrasonic imaging system

Cited By (12)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP1543854A1 (en) * 2003-12-16 2005-06-22 Novo Nordisk A/S Vibrating injection needle and method for detecting the presence of medicament therein
WO2005058395A1 (en) * 2003-12-16 2005-06-30 Novo Nordisk A/S A delivery device with a vibrating hollow conduit such as an injection needle and a method for automatically identifying whether liquid is present in a hollow conduit
WO2012066510A1 (en) * 2010-11-19 2012-05-24 Xavant Technology (Pty) Limited Vibrating needle adjustment device
US11369296B2 (en) 2011-02-01 2022-06-28 Olberon Medical Innovation Sas Needle holder
WO2014118376A1 (en) * 2013-02-01 2014-08-07 Olberon Medical Innovation Sas Needle location device
CN105228533A (en) * 2013-02-01 2016-01-06 欧伯伦医疗创新公司 Pin positioner
US10993738B2 (en) 2013-02-01 2021-05-04 Olberon Limited Needle location device
CN105377144A (en) * 2013-03-15 2016-03-02 敦提大学校董事会 Medical apparatus and its visualisation
US11123100B2 (en) 2013-03-15 2021-09-21 University Court Of The University Of Dundee Medical apparatus and its visualisation
GB2566532A (en) * 2017-09-18 2019-03-20 Active Needle Tech Ltd Vibrating probe
WO2019053469A1 (en) * 2017-09-18 2019-03-21 Active Needle Technology Ltd Medical Device
AU2018333037B2 (en) * 2017-09-18 2023-08-31 Active Needle Technology Ltd Medical device

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