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US20020177776A1 - Ultrasound detectable instrument - Google Patents

Ultrasound detectable instrument Download PDF

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Publication number
US20020177776A1
US20020177776A1 US09/984,147 US98414701A US2002177776A1 US 20020177776 A1 US20020177776 A1 US 20020177776A1 US 98414701 A US98414701 A US 98414701A US 2002177776 A1 US2002177776 A1 US 2002177776A1
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United States
Prior art keywords
instrument
layer
primer
citric acid
layers
Prior art date
Legal status (The legal status is an assumption and is not a legal conclusion. Google has not performed a legal analysis and makes no representation as to the accuracy of the status listed.)
Abandoned
Application number
US09/984,147
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English (en)
Inventor
Ewen James Crawford Kellar
Seyed Mehdi Tavakoli
Current Assignee (The listed assignees may be inaccurate. Google has not performed a legal analysis and makes no representation or warranty as to the accuracy of the list.)
BTG International Ltd
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BTG International Ltd
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Filing date
Publication date
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Assigned to BTG INTERNATIONAL LIMITED reassignment BTG INTERNATIONAL LIMITED ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: KELLAR, EWEN J.C., TAVAKOLI, SEYED MEHDI
Publication of US20020177776A1 publication Critical patent/US20020177776A1/en
Priority to US10/690,828 priority Critical patent/US7235052B2/en
Abandoned legal-status Critical Current

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    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/48—Diagnostic techniques
    • A61B8/481—Diagnostic techniques involving the use of contrast agents, e.g. microbubbles introduced into the bloodstream
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0833—Clinical applications involving detecting or locating foreign bodies or organic structures
    • A61B8/0841—Clinical applications involving detecting or locating foreign bodies or organic structures for locating instruments

Definitions

  • the present invention relates to an ultrasound reflective instrument and a method of manufacturing the same.
  • the invention relates particularly, but not exclusively to such an instrument when suitable for use in medical applications.
  • Presently known ultrasound visible instruments include that disclosed in WO 98/18387 which provides a probe insertable into a material containing a liquid and having a coating comprising a carrier material and a quantity of reactive material which, upon contacting a reactant, produces a quantity of bubbles adjacent the coating for reflecting ultrasonic energy.
  • the probe comprises a biopsy needle and the coating is positioned towards a sharp distal end thereof, thereby to facilitate the guidance and positioning thereof.
  • the coating can be provided along the entire length of the instrument or at discrete portions along its length.
  • the reactive material comprises, for example, a mixture of sodium hydrogen carbonate and citric powder contained within a single layer of a carrier material which facilitates interaction between an externally supplied fluid and the reactant.
  • the fluid permeates through the carrier material and, once the two reactive components are wetted thereby a reaction takes places which produces a plurality of bubbles which are mobile within the carrier material in a manner which enhances the ultrasound reflectivity of such of a device over and above that presently known from similar devices.
  • the present invention aims to provide a method of manufacturing such an instrument.
  • the present invention provides an instrument insertable into a medium and being capable of detection by sonic imaging equipment comprising:
  • an elongate member for insertion into said medium and having a region the position of which it is desirable to monitor;
  • bubble generating means for generating a plurality of discrete mobile bubbles at said region, whereby said bubbles are detectable by sonic imaging equipment, characterised in that:
  • said bubble generating means comprises two elements which, upon contacting with each other in the presence of a fluid, react with each other to produce said gas bubbles and in which said elements comprise first and second radially displaced layers of said elements within a fluid permeable carrier material.
  • the instrument further includes a fluid permeable intermediate layer between said two element containing layers
  • the instrument further includes a foundation layer on said instrument upon which are deposited said element containing layers.
  • said foundation layer comprises a fluid permeable layer.
  • the instrument includes a primer layer on said instrument upon which said fluid permeable carrier material is deposited.
  • the instrument includes a primer layer on said instrument upon which said fluid permeable foundation layer is situated.
  • the carrier material may comprise a hydrophilic material and preferably comprises HydrothaneTM.
  • the two elements comprise citric acid and sodium hydrogen carbonate.
  • the citric acid comprises dissolved citric acid.
  • said first layer comprises a radially inner layer and comprises citric acid and said second layer comprises a radially outer layer and comprises sodium hydrogen carbonate.
  • said first layer comprises a radially inner layer and comprises sodium hydrogen carbonate and said second layer comprises a radially outer layer and comprises citric acid.
  • the intermediate layer may comprise a hydrophilic material and preferably comprises HydrothaneTM.
  • the elongate member may include a prepared surface prepared by solvent degreasing or wet blasting.
  • said primer layer comprises an acid etched layer and preferably comprises a chromate free water based primer (Cytec BR6752) or ChronoflexTM AL80A.
  • the ratio of bubble generating means to carry material in said first or said second layer is between 20% and 200% by weight.
  • the ratio of the first to the second reactive agents is substantially 50/50 (by weight).
  • said bubble generating means is provided at one or more discrete portions along said elongate member.
  • said bubble generating means is provided along a substantial length of said elongate member.
  • the method may include the further step of depositing a fluid permeable intermediate layer between said first and second layers.
  • the method includes the further step of depositing a foundation layer on said instrument prior to deposition of said first layer.
  • the foundation layer comprises a fluid permeable layer.
  • the method includes the further step of depositing a primer layer onto said instrument prior to any of the layers of claims 1 to 4 .
  • the first and second layers comprise a hydrophilic material.
  • said first and second layers comprise HydrothaneTM.
  • said two elements comprise citric acid and sodium hydrogen carbonate.
  • said two elements comprise dissolved citric acid and sodium carbonate particles.
  • said first layer comprises citric acid and said second layer comprises sodium hydrogen carbonate.
  • said first layer comprises sodium hydrogen carbonate and said second layer comprises citric acid.
  • said intermediate layer comprises a hydrophilic material which preferably comprises HydrothaneTM.
  • the method includes the further step of preparing the instrument surface by solvent degreasing or wet blasting.
  • said primer layer comprises an acid etched layer, preferably a chromate free water based primer (Cytec BR6752) or ChronoflexTM AL80A.
  • the method includes the step of adding the first and second elements to a carrier material to form said layers and in which said elements are added to said carrier material in a ratio of between 20% and 200% by weight.
  • the first and second reactive elements are added in a ratio of substantially 50/50 by weight.
  • the method includes the step of applying the layers at one or more discrete portions along said elongate member.
  • the method includes the step of applying the layers at one or more discrete portions along said elongate member.
  • FIG. 1 is a general view of the present invention being used on a patient
  • FIG. 2 is a perspective view of a biopsy needle in accordance with one aspect of the present invention.
  • FIG. 3 is an enlarged cross-sectional view of a portion of the needle shown in FIG. 2;
  • FIGS. 4 - 7 are enlarged cross-sectional views of various forms of the present invention.
  • FIG. 8 is a schematic illustration of the present invention and an ultrasound transducer for emitting and receiving ultrasound energy.
  • FIG. 9 is a quantitative analysis of ultrasound data for “brightness” coating ( 63 f - h ) compared to a poor coating ( 62 f - h ) on a stainless steel plate;
  • FIG. 10 is a quantitative analysis of ultrasound data for “brightness” coating of a first trial stainless steel biopsy needle
  • FIG. 11 is a further quantitative analysis of ultrasound data for “brightness” coating on a stainless steel boxing needle
  • FIG. 12 is a artists representation of the bubble production from a coating cast on a glass slide “Sample No. 88”;
  • FIG. 13 is a plot showing the relationship between time for first bubbles to be observed and the concentration of reagent present within the coating.
  • FIG. 14 is a quantitative analysis of ultrasound data for coated needles in a Tissue-Mimicking Phantom.
  • an instrument 10 in the form of, for example, biopsy needle 12 comprises an elongate needle 14 having proximal and distal ends 14 a , 14 b , the latter of which is sharply pointed.
  • a cylindrical lumen 16 extends between the ends and provides a substantially smooth exterior surface 18 having one or more regions R upon which is deposited a coating 20 , the function of which will be described in detail later herein.
  • the needle 12 also includes a mounting 22 generally of a plastics material which surrounds and is secured to the proximal end.
  • a stylet 24 is slidable and removably disposed within the lumen 16 and substantially blocks the distal end 14 b and helps form a cutting edge for use during the insertion process. When removed the stylet 24 exposes a threaded or ribbed portion 26 on mounting 22 onto which a hypodermic syringe may be removably secured and used in a manner well known and therefore not described further herein.
  • the instrument 10 of the present invention is characterised in that the coating 20 is of a multilayer construction as shown in detail in FIGS. 4 - 6 . Whilst the detail of the coating will be discussed later herein, it is worth highlighting that the example of FIG. 3 shows the coating 20 positioned towards the distal end 14 b of a needle which assists the accurate positioning of the end. Other positions may however be used to advantage and the distance between regions of deposited coating 20 may be preset thereby to assist in determining how deep the instrument has been inserted. Alternatively, when it is desirable to monitor the position of the entire needle, the coating may be provided along the entire length of the needle.
  • the deposited coating 20 comprises a carrier material 30 and means for generating a plurality of very fine mobile gas bubbles.
  • the function of the carrier material is to provide a matrix or support site for the bubble generating means which can take any one of a number of forms, examples of which are detailed below.
  • the bubble generating means comprises a reactive substance which, upon interaction with a reactant acts to produce the required bubbles.
  • a secondary function of the carrier material 30 is to provide a bulk of material which affords mobility of the bubbles to facilitate ultrasonic detection thereof.
  • the carrier material may be chosen so as to have an ultrasonic impedance the same as or close to that of the material in which it is to be inserted. By matching the impedance in this manner, it is possible to reduce the reflections at the interface between the carrier material and the material in which it is inserted and increase the quantity of ultrasound interacting with the bubbles. Clearly, any such increase will enhance the quality of any reflected ultrasound signal.
  • the carrier material is used to radially separate the two elements 32 a , 32 b of the effervescent material (the reactive substance) such that, upon contact with a liquid (the reactant) the liquid must first permeate through the carrier material 30 and bubbling can only commence once a suitable saturation level has been achieved.
  • the bubbles are mobile in two senses. Firstly, they are mobile in the sense that they are able to migrate through the carrying material and, secondly, they are mobile in the sense that they grow in size as they develop. Typically, a bubble generated in this manner will grow into a bubble having a diameter of at least and generally greater than 5 microns.
  • the carrier material 30 also acts to protect the effervescent material 32 which tends to be less robust and hence susceptible to damage during handling.
  • the carrier material comprises a hydrophilic material the advantages and function of which will be described later herein.
  • epoxy based resins are suitable for such applications. Such materials can be applied by a simple dipping technique followed by a curing step (which may simply comprise exposure to ambient air or may comprise a heating step) and are highly bio-compatible, should the instrument be required for use on a human or animal patient.
  • a suitable material is polyurethane such as that sold under the trade name HydrothaneTM which can have a plurality of interconnecting pores or may be of a closed cellular structure and can be “engineered” to create a pore structure suitable for a particular application.
  • polyurethaneTM such as that sold under the trade name HydrothaneTM which can have a plurality of interconnecting pores or may be of a closed cellular structure and can be “engineered” to create a pore structure suitable for a particular application.
  • Polyolefins such as polyethylene or polypropylene may also be suitable examples.
  • polystyrene which, whilst normally would be hydrophobic, can be manufactured in hydrophilic form.
  • the effervescent material chosen may comprise a number of different elements but the examples shown herein comprise sodium hydrogen carbonate and citric acid powder.
  • Such a material is highly bio-compatible and therefore presents little if any hazard when the needle is employed for use on the human or animal body.
  • Other materials may be employed, particularly when bio-compatibility is not an issue. It is worth mentioning that the ratio of the two reactive substances to each other and the ratio of the total reactive substance to the carrier material each have a significant effect on the performance of the present invention.
  • the two elements 32 a , 32 b may be radially separated in any one of a number of different ways.
  • the citric acid containing layer 30 b is deposited first and a subsequent sodium hydrogen carbonate containing layer 30 a is provided over the top thereof. Details of the deposition process are provided later herein.
  • incoming fluid will transport at least a small portion of the sodium hydrogen carbonate through the cellular structure of the carrier material 30 a and into the citric acid containing layer 30 b such that the two elements may interact and produce the required bubble generating reaction.
  • reaction between the two elements is accelerated and bubbles are produced at a more rapid rate. Tests show that this arrangement can produce ultrasound detectable bubbles in as little as 8-20 seconds.
  • FIG. 5 illustrates the opposite arrangement in which the first deposited layer includes the sodium hydrogen layer carbonate 30 a over which is deposited a second layer 30 b containing the citric acid 32 b . It has been found that this arrangement produces bubbles after some 6 minutes but these bubbles are still of a size suitable for use with ultrasound detecting apparatus. This arrangement might lend itself to situations where it is desirable to delay the generation of the bubbles.
  • FIG. 6 illustrates a modification of the arrangement shown in FIG. 4 in which an intermediate layer of carrier material 30 is provided in order to separate the two element containing layers 30 a , 30 b .
  • the advantage of this arrangement resides in the fact that minimises reaction between layers as they are laid down.
  • FIG. 7 illustrates the reverse arrangement of FIG. 6 in which the sodium hydrogen carbonate containing layer 30 a is deposited first and separated from the citric acid containing layer 30 b by an intermediate barrier layer 30 comprising carrier material. Again, separation of the two elements 32 a , 32 b from each other by an intermediate layer helps regulate the rate at which bubbles are generated.
  • Citric acid 99% powder form from Aldrich Chemical Co. (Cat. No. C8,315-5)
  • Wet blasting medium Alumina grit (60 mesh) from Vapormatt/Hydrate Systems Ltd.
  • the substrate upon which the coating were applied were:
  • Biopsy needles of two different gauges were used for this series of experiments.
  • the needles are hereafter referred to by the colors of the respective needle hubs.
  • Each needle consisted of a solid inner stylus and hollow outer cannula, the dimensions of which are given below.
  • Tissue-Mimicking Material prepared at St George's Hospital.
  • a Microvision MV2100 CCD camera with a MV-120z microscope attachment was used in conjunction with a video recorder, Sony U-Matic V0-8800P.
  • a video recorder Sony U-Matic V0-8800P.
  • test samples were placed in a fixed position relative to the probe and supported on a steel block immersed in the water bath. This ensured that scatter from the generated bubbles and the coated surface, rather than specular reflection, was responsible for the returning echoes.
  • the distance from the probe, together with the horizontal orientation of the samples, gave the least sensitive position for recording the echo intensities. In vivo, the angle of the coated needle would be more conducive to reflection and should give higher intensity echoes.
  • the most active coatings contained the most gas producing reagent i.e. >50%/wt assuming an equal ratio of the reactive components (0.25 g citric acid and 0.25 g sodium hydrogen carbonate in 1 g HydrothaneTM).
  • test matrix with the average peel loads is defined in Table 1.
  • Coating 3 had similar bubble producing activity to the first two, however it was extremely difficult to produce samples with few or no internal bubbles. It is assumed that these bubbles are the product of premature reaction between the reagents prior to complete solvent evaporation due a lack of a polyurethane dividing layer.
  • a base layer of pure HydrothaneTM was incorporated because it was against this that the adhesion tests were made and the effect of a citric acid loaded polymer on the primed surface is not known. It is thought that such a layer should adhere sufficiently well, in which case the presence of a pure HydrothaneTM base layer is not absolutely necessary.
  • the concentration of reagent within the coating was 200%/wt of total reagent in the dry HydrothaneTM matrix i.e. 2 g citric acid in 1 g matrix and 2 g sodium hydrogen carbonate in 1 g matrix.
  • the nominal pure HydrothaneTM solution concentration used was 20%/wt in THF or 0.1774 g/ml.
  • the production of the needles entailed an initial degrease operation, followed by light wet blasting (described in 5.2).
  • the Cytec BR6757 primer was applied by dipping the needles into the solution.
  • the needles were dipped but not sprayed, as in the previous work carried out on flat stainless steel, because the shape and size of the needles readily allowed the primer to dry.
  • the needles were then cured in an oven at 100° C. for one hour. This was preferred at 100° C. instead of 120° C., as recommended, because of the possible degradation of the plastic ends of the needles.
  • the needles were then coated with each layer of the HydrothaneTM by dipping them into the appropriate solution and suspending them vertically in air, at room temperature in a static fume cupboard until all of the solvent had evaporated. The dipping process was then repeated until all the layers had been applied. The coated needles were stored in a dessicator until required.
  • TMM tissue mimicking material
  • Tissue Mimicking Material (TMM)
  • the TMM was submerged in a water bath at 37° C. and the selected biopsy needles inserted into it.
  • the ultrasound probe was held in place above the phantom, with the transducer elements submerged in the water. It should be noted that the spatial relationship between the probe and the needle was designed to replicate optimal conditions for image generation, rather than the “worst case”, used in the earlier analysis. Images were acquired from the region of interest (ROI), digitised and stored, as described above, for further analysis. The data acquisition process was calibrated so that the relationship between the brightness of the digitised image and the, actual reflectivity/backscatter (dB) was expressed by the following formula:
  • the order in which the layers form the coating has been shown to have a substantial effect on the performance of the coating, in terms of rate and level of bubble production.
  • the layer containing citric acid is most preferably below that containing sodium hydrogen carbonate.
  • biopsy needles and the like can be coated easily through a simple dipping technique which produces samples with smooth coating of even thickness.
  • Other production methods such as, for example, spraying may be used as and where appropriate.

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  • Life Sciences & Earth Sciences (AREA)
  • Medical Informatics (AREA)
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  • Nuclear Medicine, Radiotherapy & Molecular Imaging (AREA)
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  • Heart & Thoracic Surgery (AREA)
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  • Animal Behavior & Ethology (AREA)
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  • Veterinary Medicine (AREA)
  • Hematology (AREA)
  • Materials For Medical Uses (AREA)
  • Ultra Sonic Daignosis Equipment (AREA)
  • Surgical Instruments (AREA)
  • Investigating Or Analyzing Materials By The Use Of Ultrasonic Waves (AREA)
US09/984,147 1999-04-28 2001-10-29 Ultrasound detectable instrument Abandoned US20020177776A1 (en)

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GBGB9909801.4A GB9909801D0 (en) 1999-04-28 1999-04-28 Ultrasound detectable instrument
GB9909801.4 1999-04-28
PCT/GB2000/001451 WO2000066004A1 (fr) 1999-04-28 2000-04-17 Instrument detectable par ultrasons

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EP (1) EP1173096B1 (fr)
JP (1) JP2002542871A (fr)
AT (1) ATE274327T1 (fr)
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DE60013268D1 (de) 2004-09-30
GB9909801D0 (en) 1999-06-23
ATE274327T1 (de) 2004-09-15
US7235052B2 (en) 2007-06-26
AU4580900A (en) 2000-11-17
US20040138566A1 (en) 2004-07-15
EP1173096B1 (fr) 2004-08-25
WO2000066004A1 (fr) 2000-11-09
EP1173096A1 (fr) 2002-01-23
JP2002542871A (ja) 2002-12-17
DE60013268T2 (de) 2005-09-08

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