WO2011073725A1 - Handheld automated biopsy device - Google Patents

Handheld automated biopsy device Download PDF

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Publication number
WO2011073725A1
WO2011073725A1 PCT/IB2009/055749 IB2009055749W WO2011073725A1 WO 2011073725 A1 WO2011073725 A1 WO 2011073725A1 IB 2009055749 W IB2009055749 W IB 2009055749W WO 2011073725 A1 WO2011073725 A1 WO 2011073725A1
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WO
WIPO (PCT)
Prior art keywords
biopsy
previous
device according
biopsy device
tissue
Prior art date
Application number
PCT/IB2009/055749
Other languages
French (fr)
Inventor
Luc Malarme
Eric Chevalier
Original Assignee
Luc Malarme
Eric Chevalier
Priority date (The priority date 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 date listed.)
Filing date
Publication date
Application filed by Luc Malarme, Eric Chevalier filed Critical Luc Malarme
Priority to PCT/IB2009/055749 priority Critical patent/WO2011073725A1/en
Publication of WO2011073725A1 publication Critical patent/WO2011073725A1/en

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Classifications

    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0266Pointed or sharp biopsy instruments means for severing sample
    • A61B10/0275Pointed or sharp biopsy instruments means for severing sample with sample notch, e.g. on the side of inner stylet
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B10/0233Pointed or sharp biopsy instruments
    • A61B10/0283Pointed or sharp biopsy instruments with vacuum aspiration, e.g. caused by retractable plunger or by connected syringe
    • AHUMAN NECESSITIES
    • A61MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61BDIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B10/00Other methods or instruments for diagnosis, e.g. instruments for taking a cell sample, for biopsy, for vaccination diagnosis; Sex determination; Ovulation-period determination; Throat striking implements
    • A61B10/02Instruments for taking cell samples or for biopsy
    • A61B2010/0208Biopsy devices with actuators, e.g. with triggered spring mechanisms
    • 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

Abstract

The invention relates to a biopsy device (11) integrating automated biopsy mechanism in one handheld housing in order to position automatically the biopsy mechanism with a high accuracy in a patient 's body for obtaining relevant tissue samples. One embodiment of the invention is that the biopsy mechanism is made of at least one longitudinal profiled élément such that axial movements and/or rotations around the main élément axis is generated directly or indirectly from at least one actuator.

Description

Handheld automated biopsy Device

SUMMARY

This Summary is provided to introduce a selection of representative concepts in a simplified form that are further described below in the Detailed

Description. This Summary is not intended to identify key features or essential features of the claimed subject matter, nor is it intended to be used in any way that would limit the scope of the claimed subject matter.

The invention relates to a biopsy device

integrating automated biopsy mechanism in one handheld housing in order to position automatically the biopsy mechanism with a high accuracy in a patient's body for obtaining relevant tissue samples.

One embodiment of the invention is that the biopsy mechanism is made of at least one longitudinal profiled element such that axial movements and/or rotations around the main element axis is generated directly or indirectly from at least one actuator.

DEFINITIONS

Imaging means :

It comprises, not exclusively, ultrasound imaging means (with Doppler capabilities or not)

and/or microwave imaging means and/or elasticity imaging means and/or magnetic resonance

imaging means and/or Optical imaging means and/or photo-acoustic imaging means,

and/or electric impedance imaging, and/or electric resistance imaging, and/or electric

capacitance imaging and/or terahertz imaging and/or molecular imaging or a combination of them

Diffusivity imaging :

A method of identifying a region within a tissue portion having a different diffusivity than the surrounding tissue of the tissue portion comprising:

Causing a deformation of the tissue portion;

determining at least one of the properties of wave speed and wave attenuation in the tissue when the tissue portion is deformed to yield a pattern of the property of wave speed or wave attenuation in the tissue; evaluating the pattern of at least one of the properties of wave speed and wave attenuation in the tissue to identify a change in the pattern indicating the presence and the location of the differing

diffusivity region of tissue; and calculating the diffusivity characteristics of the tissue portion by inverse problem techniques from wave speed and wave attenuation to tissue diffusivity BACKGROUND OF THE INVENTION

1. Field of the Invention

The present invention relates in general to biopsy devices, and more particularly to biopsy devices having automated biopsy mechanism for tissue sampling in one handheld housing.

2. Description of Related Art

The procedure known as biopsy, or the removal of samples of human and animal internal tissue, has been for many years a favored method for the non open surgical diagnosis of tissue. Using biopsy needles one can take out samples from deeply located organs. This kind of sampling, is usually carried out in such a way that a doctor inserts a needle assembly through the skin and to the desired sampling location. This can be done thanks imaging guiding methods as ultrasound imaging. Several kinds of biopsy needles are employed to biopsy the internal organs. One of the most

commonly used needle assemblies comprises a slidably provided inner needle within a hollow outer needle. Using this kind of instrument, sampling has been performed in a two-step manual technique in which the outer hollow cutting cannula telescopically receives the inner stylet (or needle) which is slidable between retracted and extended positions relative to the cannula. The needle contains a specimen receiving slot near its sharpened distal end. In performing the first step of the technique, the physician places the tip of the needle against the tissue mass to be sampled and manually drives the needle forward into the tissue mass. To carry out the second step, the physician manually drives the cutting cannula forwardly over the needle, thereby severing a tissue sample and retaining it within the needle slot inside the cannula's hollow interior. Then the entire needle assembly containing the collected tissue sample is withdrawn, whereafter the sample can be taken out and analyzed. Actually many physicians utilize a TRU-CUT(R) biopsy needle that is described in above mentioned U.S. Pat. No. 3,477,423 to Griffith. Such manually operated two-step devices are awkward to manipulate, and the tissue samples obtained may often be unsatisfactory. The depths to which the needle and the cannula are driven into the tissue mass must be carefully controlled for accuracy and efficiency. Caution is required, as well, in applying the force with which the needle and the cannula are plunged forward. Too little force may not sever the tissue sample from the mass. Too much force may cause unnecessary damage to the surrounding vital tissues. Several automated biopsy instruments have been invented to improve the manual procedure and make it easier. The examples of the automated devices are seen in U.S. Pat. No. 4,767,684, issued May 26, 1987 to H. G. Leigh for "Biopsy Device". It discloses a movable needle telescopically received in a hollow movable cannula, both the needle and the cannula being mounted to hubs within a pistol-style grip. In use the needle is first manually advanced into the tissue and the cannula is then driven over the needle by

depressing a trigger. A similar instrument designed by D. N. Mehl, through U.S. Pat. No. 4,733,671, issued Mar. 29, 1988, includes a pistol-style squeezable hand grip for single hand operation. A spring tensioned sliding cannula, including a configured cutting edge, actuates by a squeeze trigger and cam arrangement to slide over a fixed position needle for entry into a tissue sample area. Another automated device is found in U.S. Pat. No. 4,799,154, issued Oct. 13, 1987 to P. G. Lindgren for "Tissue Sampling Device". It is composed of a mechanism in which a release button is depressed to cause a spring-loaded needle to be advanced into the tissue mass. The forward movement of the needle also triggers the delayed release of a spring-loaded outer cannula, which slides over the needle to sever the tissue sample. U.S. Pat. No.

4,924,878, issued May 15, 1990 to J. E. Nottke for "Actuating mechanism for biopsy needle " and U.S. Pat. No. 4,958,625, issued Sep. 25, 1990 to J. S. Bates for "Biopsy needle instrument", disclose two other

automated devices with sequential movement of the needles. In any event, the various automated biopsy instruments presently known tend to be heavy and difficult to manipulate. Such limitations diminish the physician's control over the instrument and the precision with which biopsies may be performed. These instruments may be subject to inadvertent movement or torque which may, in turn, subject the patient to unnecessary trauma and risk.

That is why only a few devices are marketed ( see www . bostonscientific . com , ww . ardnordic . com , www♦ reastbiopsy♦ com, www . senorx . com ) and widely used by physicians. These devices propose an automatic tissue multi-sampling but no automatic moving to position the needle & cannula close to the relevant tissue area. For example, in breast cancer biopsy, radiologists (women and men) have difficulty to penetrate manually dense breast tissue (especially in stereotactic configuration where breast is maintained compressed) .The trends are clearly towards a full automatization for a better biopsy quality. This translates in two key features:

- Comfort, Manipulation and accurate positioning for the practitioner

- Tissue sampling quality: relevant part of the tissue, no contamination during the extraction, sample conditioning up to complete analysis.

The present invention provides a device which facilitates the means to capture relevant biopsy specimen. The invention describes an electro- mechanical device to accomplish automatically smart minimally invasive medical procedures by using at least one longitudinal profiled element not only designed for tissue sampling but also for accurate axial moving and/or rotation around the main element axis. It is also proposed that said element integrate targeted contrast agents for a better follow-up through imaging guiding (ultrasound imaging in

particular) allowing an accurate positioning.

BRIEF DESCRIPTION OF THE DRAWINGS

The present invention is illustrated by way of example and not limited in the accompanying figures in which like reference numerals indicate similar elements and in which:

FIG 1: one longitudinal profiled element

(dimensions are used as example)

FIG 2 a-b: one complete device (design is just one example) : it illustrates the complete integration of biopsy mechanisms, integrated imaging function and user interface embedded on a handheld housing.

Fig 3 : truncated -proximal- view of Needle with targeted ultrasound contrast agent coating

Fig 4: Truncated -proximal- view of needle with examples of sensor and other integrated functionalities

Fig 5: biopsy process with imaging probe and biopsy device integrating motion sensing capabilities where the physician can accurately guided the needle and cannula trajectory up to the relevant tissue

(target) on a monitor. Motion sensing capabilities use wireless communication type Fig 6: localized Cancer therapy process (3 main steps) using implantable device for specific drug delivery with controlled kinetic release

Fig 7: the biopsy device of one embodiment of the present invention - Block diagram

Fig 8 : the biopsy device of one embodiment of the present invention - Block diagram including vacuum means

Fig 9 : the biopsy device of one embodiment of the present invention - Block diagram including cryogenic means

Fig 10: truncated -proximal - view of one

embodiment of the Biopsy mechanism including needle and cannula; their movements (axial and/or rotation) are separately actuated.

DESCRIPTION

A biopsy device comprising:

1- A housing 2

2- At least one biopsy mechanism moveably connected to said housing and comprising at least one longitudinal profiled element 5b

3- At least one actuator for moving said biopsy mechanism outward relative to said housing and for operating said biopsy mechanism 4

such that axial moving and/or rotation around the main element axis 5a are generated directly or

indirectly from at least one said actuator. These movements can be applied according the both directions (forward or backward) and/or clockwise or

anticlockwise. The physician manages directly -by switch or pedal- or indirectly - voice for example - these operating modes of the device. The advantages in such configurations are the ergonomics and efficiency during the penetration where a wide type of tissue can be interacting with the biopsy mechanism (dense or soft breast) . Moreover, the hardness of tumour is various from one patient to the other and such

capabilities of the said device bring accuracy by adapting the penetration force with axial moving and/or rotation of said biopsy mechanism thanks to a sensing method such as a force or torque sensor embedded in the device. Preferentially, the biopsy mechanism is disposable. The device could be cordless integrating a battery module 16.

One embodiment of the invention is that the biopsy device comprises longitudinal profiled element (s) is (are) manufactured with at least one geometrical structure for tissue sampling (proximal part of said element) and/or with at least one other geometrical structure to ensure rotation and/or translational movements (distal part of said element) for operating the biopsy mechanism by at least one actuator. In the proximal part, the geometrical structure can be cutting edge cavities 1 where tissues are captured during sampling. The cutting edge cavities allow the pre-cutting of relevant tissues and their trap. The final cutting and complete tissue isolation is

possible thanks to a cutting edge cannula for example. These cavities may be produced in helical patterns according to the main axis of said element. The plurality of cavity into one element allows to get multi-sampling in one run inside body's patient.

One embodiment of the invention is that the said biopsy mechanism comprises said element (s) profiled with said geometrical structure (s) (proximal part) defining at least one notch to capture tissue samples

One embodiment of the invention is that the said biopsy comprises said element (s) profiled with said geometrical structure (s) (distal part) defining a helical profile (s) to perform the conversion from a translational movement to a rotation movement and/or reciprocally of said element (s) driven by said

actuator(s) (see fig.l).

One embodiment of the invention is that the said biopsy mechanism comprises said element (s) profiled with said geometrical structure (s) (distal part) allows the relative positioning between at least two said geometrical structures (proximal part) of said elements when the said biopsy mechanism is moving. The device comprises lock mechanism means to allow an independent relative movement of said elements in rotation and/or axial displacement.

One embodiment of the invention is that the said elements are one needle 22 and one cannula 21. During the biopsy, the cannula and needle penetrate the tissue together (cannula covers the needle). For tissue sampling, only needle penetrates the relevant tissue (tumour for exemple) and capture the tissue. The needle pulls back inside the cannula. The latter cuts definitively the tissue from its environment, protects the sample (s) and allows the non dissemination of malign tissue. It is possible to make multi-sampling: the cannula remains in position and only the needle acts to capture and pulls back up to the extraction of sample. In this mode, the needle is always covered by the cannula to avoid tumourous contamination. This process can be used for example when physician is faced to micro-calcifications

The relevant tissue area can be reach with a frontal approach or with a peripherical approach.

One embodiment of the invention is that the said element (s) can be telescopic in order to optimize the integration in the housing.

One embodiment of the invention is that the said biopsy mechanism comprises the said cannula (s) profiled with the said geometrical structure (distal part) and/or said needle (s) allowing the relative positioning between cannula and needle, for example, in order to cover at least one notch of said needle with at least one part of said cannula.

One embodiment of the invention is that the said biopsy further comprises at least one sensor

integrated in the said housing 14 to optimize said element insertion in tissue by minimizing the

displacement and deformations of said tissue. The said actuator 15 is driven by using the feedback signal from said sensor according a specific algorithm.

One embodiment of the invention is that the said biopsy mechanism comprises at least one contact sensor 8 allowing the detection by a physical property and/or a chemical property of the relevant tissue area.

One embodiment of the invention is that the said biopsy mechanism comprises a least one resonator performing the following operations (exclusively or not): frequency characterization to extract

information about potential deposition inside the biopsy mechanism (a shift of the resonant frequency of the resonator) or residual materials (samples) inside the biopsy mechanism, magnetic resonance analysis or participate to enhance magnetic resonance imaging resolution .

One embodiment of the invention is that the said sensor(s) 14 or 8 is(are) a force sensor and/or a torque sensor. This additional function provides a penetration impact and trajectory inside the tumourous tissue optimal: according to the (heterogeneous) visco-elasticity of tissues, the proximity of biopsy mechanism(s) implies a global shifting of the

tumourous area and consequently an inaccuracy of capturing. Such device function adapts the penetration force of the biopsy mechanism to minimize its

influence onto the relevant -heterogeneous- tissues.

One embodiment of the invention is that the said biopsy device further comprises imaging means

integrated in one handheld said housing 3. This configuration provides comfort and ergonomics to physicians by manipulating only one device instead of two (biopsy device and ultrasound probe for example) when they practice ultrasound guided biopsy.

One embodiment of the invention is that the said biopsy mechanism integrates contrast agent (dyes and/or targeted ultrasound microsphere 6) . During an ultrasound guided biopsy in particular, such

specificity provides visibility of needle and cannula, the direct consequence is an accurate sampling. The microspheres 6 (produced by sonication for example) can be coated on the surface of biopsy mechanism(s) by dry spray but it is not the unique efficient process. Targeted ultrasound contrast materials have the following property: Ultrasound is reflected whenever there is a change in acoustic impedance. The larger the change, the more ultrasound is reflected. Gas bubbles inside microsphere have a tremendous

difference in acoustic impedance as compared to surrounding tissue due to the large differences in density, elasticity and. compressibility. One

configuration is to use a plurality of microsphere with various diameters. Each set of microspheres with same diameter is placed specifically in needle and/or cannula. By generating ultrasound waves with several frequencies, we are able to detect independently - harmonically- the set of microspheres and then the part of the biopsy mechanism where they are fixed.

One embodiment of the invention is that the said biopsy mechanism is a part of the said imaging means. For example, at least one transducer is embedded in at least one said element (needle and/or cannula) and act as a complementary mean to perform imaging and

increase resolution. Indeed, the transducer ( s ) is in direct contact with the relevant tissue for better interactions and characterizations.

One embodiment of the invention is that the said imaging means comprises an ultrasound probe

integrating at least an array of ultrasound

transducers capable of transforming ultrasound waves impinging on them in electric signals and/or

generating ultrasound waves by electric excitation.

One embodiment of the invention is that the said biopsy mechanism generates adapted mechanical waves for real time elasticity or diffusivity imaging At least one transducer embedded in the biopsy mechanism generates these mechanical waves. It results an improved image resolution. The physician is much conveniently guided during the procedures.

One embodiment of the invention is that the said biopsy mechanism generates adapted mechanical waves for real time diffusivity imaging for a better

resolution .

One embodiment of the invention is that the said biopsy device is characterised in that the said biopsy mechanism comprises, in a proximal part, a part allowing incision(s) in the patient's body.

One embodiment of the invention is that the said biopsy device is characterised in that the said biopsy mechanism integrates cryogenic means 19, 20. During an intervention, minimizing bleeding and/or pre-treatment of tumourous tissues could be required by physicians or surgeons. One suitable cryogenic mean consists on the integration of a -miniature- pulse tube 19 into the biopsy mechanism; the compressor 20, linked to the pulse tube, being placed externally to the device.

One embodiment of the invention is that the said biopsy device characterised in that the said biopsy mechanism integrates vacuum means 17 for improving the said tissue sampling. The vacuum function or

aspiration function allows the capture of higher quantity of relevant tissue. The hardware module for vacuum or aspiration can be integrated completely or partially inside the housing of the device. If the vacuum module is placed externally of the device, a soft tubing is required to perform vacuum at the biopsy mechanism level. An alternative is that a micro-pump can be integrated directly inside the housing of the device to perform aspiration of tissue. As a complementary function, cleaning by

circulating specific liquid inside the biopsy

mechanism and pumped by said micro-pump is suitable to ensure rigorous multi-sampling without corking.

A carrousel 18 having an individual sample stock selection is linked to the vacuum means 17 to receive the samples.

One embodiment of the invention is that the said biopsy device used the current intensity from the said actuator to characterize the resistance undergone by the biopsy mechanism during its penetration into tissue, representing the hardness of the tissue. This is a complementary monitoring in real time for a better quality of biopsy and allows an optimal insertion of the said biopsy mechanism 5a. By tuning rotation and/or axial moving velocity and/or torque and/or force according the current intensity, the device adjusts in an optimal way the penetration force et minimizes its impact on tissue optimal pain management .

One embodiment of the invention is that the said element comprises at least one micro-structured surface and/or at least one dedicated chemically functionalized zones 7 in order to increase the said tissue sampling yield and specificity during tissue apposition. The said micro-structured surface could be hydrophobic or hydrophilic according to the

application. One configuration is that the cutting edge cavities of a needle are coated and/or micro- structured 7. The cannula could be micro-structured with hydrophilic or hydrophobic properties according to the application. We consider a device for tissue sampling and analyzing: a device with a tissue sampling mechanism which consists to penetrate up to the relevant tissue, performing tissue capturing thanks to micro-structured and/or at least one dedicated chemically

functionalized zones on the said sampling

mechanism ( s ). Either the samples are extracted and used for histological and chemical analysis, either the sampling mechanism(s) and/or the device integrates means for histological and/or chemical analysis like chromatography system or mass spectrometer. This advantage allows quasi- immediate sample

investigations and gives to the patient results quicker (about hours) .

One embodiment of the invention is that the said element comprises a serie of different micro- structured surfaces and/or a serie of different dedicated chemically functionalized zones in order to capture tissue with different specificity during at least one penetration in the patient's body. In particular, this advantage provides multi-sampling (cell or tissue) in one run inside the patient's body.

One embodiment of the invention is that the said micro-structured surfaces and/or the said dedicated chemically functionalized zones are dismantled and directly compatible with mass spectrometer and/or other relevant analytical instrumentation for analysis and characterizations. The said mass spectrometer can be miniaturized and placed in the Physician's office for a very quick answer to the patient. Hysto-anatomo- -pathologist can interact via internet or mobile phone or other media to perform supplementary data interpretation and relevant complementary diagnostic.

Specific software module (or application) for cell phone and/or internet could be used.

One embodiment of the invention is that a

dedicated analytical instrumentation - compatible with the said biopsy device - allows the relevant analysis from the said tissue sampling. For example, the biopsy mechanism is compatible with a disposable chamber integrated in an analytical instrumentation, such as mass spectrometer or chromatograph or TOF

spectrometer. The said chamber could interact with electro-desorption or induction fluidic or assisted laser system for sample preparation.

One embodiment of the invention is that the said biopsy device further comprises integrated anaesthesia means for anaesthesia product delivery before the said biopsy mechanism penetration in the patient's body

One embodiment of the invention is that the said imaging means comprises at least optical transducer integrated in the handheld said housing to perform photo-acoustic imaging in particular for

dermatological biopsy.

One embodiment of the invention is that a portion of the said biopsy mechanism comprised of a first insulating material, and a passive resonance circuit having an inductor, a capacitor, and optionally a resistor, wherein:

(a) said first insulating material is disposed on said inductor, wherein said first insulating material is biocompatible and forms an impermeable barrier around said inductor; and

(b) the resonance frequency of said circuit or said portion corresponds substantially to a resonance frequency of a rotational frequency of the B field of the MR scanner applied by the magnetic resonance imaging system; the said biopsy mechanism is imageable by a magnetic resonance imaging system. Also, in certain embodiments there is provided a biopsy

mechanism comprised of a needle and/or cannula, a passive resonance circuit having an inductor, a capacitor and a resistor wherein the said biopsy mechanism is imageable by a magnetic resonance imaging system. This configuration improved magnetic resonance imaging and increase the biopsy accuracy when it is imaging guided. This can be adapted usefully for stereotactic biopsy process. One advantageous

configuration is that the device comprises at least one antenna as emitter and receiver interacting with the resonator integrated in the biopsy mechanism and performing magnetic resonance imaging. Magnet (s) could be further implemented inside the device or placed externally but in proximity of the patient.

One embodiment of the invention is that a biopsy device comprises at least one sensor for positioning in space, according at least one referential, the needle and cannula. This function could be interact with stereotactic biopsy in order to position with high accuracy the needle and cannula for sampling: during the biopsy, the device interact with the stereotactic system and in real time the physician follows up with precision the needle and/or cannula trajectory with precision. It is possible to envisage the extrapolation of the needle and/or cannula trajectory (by software for example) up to the relevant tissue during penetration in order to adjust if needed and reach the target with high accuracy.

The said sensor can be integrated in the said biopsy mechanism. The said sensor can be micro- accelerometer . The device becomes a wireless motion- sensing biopsy system.

One advantageous configuration is that the biopsy device 11 comprises device comprising circuitry that senses physician hand movements, the circuitry

including at least two gyroscopic sensors including a first sensor that senses pitch and a second sensor that senses yaw, and the circuitry including a transmitter that transmits data corresponding to the sensed movement to a host computing system coupled to the biopsy device.

In imaging-guided biopsy, we propose that the both biopsy device 11 and imaging probe 10 comprise

specific circuitry that senses physician hand

movements, each circuitry including at least two gyroscopic sensors including a first sensor that senses pitch and a second sensor that senses yaw, and each circuitry including a transmitter that transmits data corresponding to the sensed movement to a host computing system coupled to the devices. This gives an accurate positioning (relative or absolute according to a fixed referential) between the imaging probe and the biopsy device and by extension (image treatment) between the target 9, or tumor, or relevant tissue area. The physician, in real time, can be informed with the monitor display of the position of the target (or tumor, or relevant tissue area) and the position of the biopsy mechanism (or needle) .During the penetration of the needle for example the trajectory is calculated and extrapolated up to the target position. Any deviation is warned and a refresh trajectory is proposed to the physician. Other

sensors, such as a third gyroscopic sensor that senses roll, one or more linear accelerometers , and/or one or more magnetometers may be incorporated into the these devices, such as to sense gestures that map to

functions that may be performed. Each device may include an enable switch, such as a capacitive

proximity sensor that is actuated when the physician's hand is closed, or a mechanical button that is

actuated when depressed, such that the circuitry transmits movement information only when the enable switch is actuated. Each device can communicate by wireless technology (Bluetooth...)

We consider a device comprising at least one actuator, at least one tissue sampling mechanism such that at least one biosensor is integrated in the said tissue sampling mechanism. The objective of such device is to perform in vivo analysis and extract information about the captured tissue:

characterization of the malignancy of captured tissue. This device could integrate imaging means to position with high accuracy the biosensors. One embodiment is that the said tissue sampling mechanism comprises at least one micro-structured area and/or at least one chemically functionalized area. One advantage

regarding this device is that the said tissue sampling mechanism is thinner as standard biopsy needles and then much less invasive and pain for patient. The process or method is then the penetration of the said tissue sampling mechanism integrating at least one biosensor up to the relevant area (possibility to perform with imaging guiding) , performing the analysis thanks to the biosensor ( s ) , and extract information about the malignancy of the captured/analyzed tissue. The results are given about hours to keep informed patients as quick as possible about his/her health. One embodiment is that the said biosensor is designed to interact specifically with stem cells or specific molecule (s) from stem cells.

The handheld biopsy device of the present

invention could be wireless. This requires a system coupled with the handheld piece to recharge the battery. The system may incorporate other

functionalities as physician interface for operating mode selection of the biopsy device, sensor

monitoring, tissue and biopsy mechanism visualization. The system can communicate with computer. Such

functionalities may be directly incorporated by software on computer.

While preferred embodiments of the present

invention have been shown and described herein, it will be obvious to those skilled in the art that such embodiments are provided by way of example only.

Numerous variations, changes, and substitutions will now occur to those skilled in the art without

departing from the spirit and scope of the appended claims. Additionally, each element described in relation to the invention can be alternatively

described as a means for performing that element's function .

Claims

What is claimed is:
1- A biopsy device comprising:
a- a housing
b- at least one biopsy mechanism moveably connected to said housing and comprising at least one longitudinal profiled element
c- at least one actuator for moving said biopsy mechanism relative to said housing and for operating said biopsy mechanism such that said actuator
generates axial moving and/or rotation around the main axis of said longitudinal profiled element.
2- The biopsy device of claim 1 wherein said biopsy mechanism comprises at least two longitudinal profiled elements such that said actuator generates independently of one another axial moving and/or rotation around the main axis of said element.
3. The biopsy device of claims 1 or 2 wherein said actuator is an electric motor.
4- The biopsy device according to claim 3 wherein said actuator make axial movement with an accuracy less than +/- 0.5mm.
5- The biopsy device according to any one of previous claims wherein the proximal part of said longitudinal profiled element is manufactured with at least one geometrical structure for tissue sampling.
6- The biopsy device according to any one of previous claims wherein the proximal part of said geometrical structure defines at least one notch and/or cavities to capture tissue samples such that said cavities and/or notch can have cutting edge. 7- The biopsy device according to any one of previous claims wherein said geometrical structure further comprises in its distal part a profile to perform the conversion from an axial movement to a rotation around the main axis of the said element;
preferentially, the said profile has helical topology.
8- The biopsy device according to any one of previous claims wherein said elements are one needle and one cannula.
9- The biopsy device according to any one of previous claim wherein said geometrical structures of said cannula and said needle allow a relative
positioning between cannula and needle, in order to cover at least one notch or cavity of said needle with at least one part of said cannula.
10- The biopsy device according to any one of previous claims wherein at least one said element is telescopic .
11- The biopsy device according to any one of previous claims wherein said actuator is a combination of at least one electric motor and at least one spring .
12- The biopsy device according to any one of previous claims wherein at least one sensor embedded in said housing is used to optimize said element insertion into tissue by minimizing the displacement and deformations of said tissue, the said actuator being driven by using the feedback signal from said sensor according a specific algorithm.
13- The biopsy device according to any one of previous claims further comprising imaging means such that the said biopsy device including said imaging means are integrated in one said handheld housing.
14- The biopsy device according to any one of previous claims wherein the said biopsy mechanism is a part of the said imaging means such that it integrates at least one transducer.
15- The biopsy device according to any one of previous claims wherein the said imaging means
comprises an ultrasound probe integrating at least an array of ultrasound transducers capable of
transforming ultrasound waves impinging on them in electric signals and/or generating ultrasound waves by electric excitation, the said transducers being implemented into the said housing such that they allow the imaging of said biopsy mechanism inside the patient's body and preferentially, some transducers are tilted relative to others.
16- The biopsy device according to any one of the previous claims characterised in that the said biopsy mechanism generates adapted mechanical waves for real time diffusivity imaging thanks to at least one transducer or at least one actuator integrated into the said biopsy mechanism.
17- The biopsy device according to any one of the previous claims characterised in that the said biopsy mechanism generates adapted mechanical waves for real time elasticity or poro-elasticity imaging thanks to at least one transducer or at least one actuator integrated into the said biopsy mechanism.
18- The biopsy device according to any one of the previous claims characterised in that the said biopsy mechanism comprises a part allowing incision (s) in the patient's body.
19- The biopsy device according to any one of previous claims characterised in that the said biopsy mechanism integrates cryogenic means or Radiofrequency means to perform pre-treatment of relevant tissue or to control and minimize bleeding.
20- The biopsy device according to any one of previous claims characterised in that the said biopsy mechanism integrates vacuum means for improving the said tissue sampling.
21- The biopsy device according to any one of previous claims characterised in that the said biopsy mechanism integrates at least one biocompatible adhesive material for improving the said tissue sampling and preferentially, the said biocompatible adhesive material is fixed in the said geometrical structure of element.
22- The biopsy device according to any one of previous claims characterised in that the said biopsy mechanism further integrates at least one electrode to perform tissue characterizations and/or electric impedance imaging.
23- The biopsy device according to any one of previous claims wherein the current intensity from the said actuator is monitored to characterize the
hardness of said tissue and its environment and is used to control the said actuator optimally into patient's body.
24- The biopsy device according to any of
previous claims wherein the said element comprises at least one micro-structured surface and/or at least one dedicated chemically functionalized zones in order to increase the said tissue sampling yield and
specificity during tissue apposition.
25- The biopsy device according to any of previous claims wherein the said element comprises a set of different micro-structured surfaces and/or a set of different dedicated chemically functionalized zones in order to capture tissue with different specificity during at least one penetration in the patient's body.
26- The biopsy device according to any one of the previous claims wherein the said micro-structured surfaces and/or the said dedicated chemically
functionalized zones are dismantled and directly compatible with mass spectrometer and/or other relevant analytical instrumentation.
27- The biopsy device according to any of the previous claims wherein a dedicated analytical instrumentation allows the relevant analysis and information from the said tissue sampling in
particular the malignancy of said tissue.
28- The biopsy device according to any one of previous claims further comprising integrated
anaesthesia means for anaesthesia product delivery before the said biopsy mechanism penetration in the patient's body.
29- The biopsy device according to any one of the previous claims wherein the said imaging means comprises at least one optical transducer to perform photo-acoustic imaging.
30- The biopsy device according to any one of previous claims characterised in that the said biopsy mechanism further integrates at least one contact sensor allowing the recognition of the relevant tissue area for sampling.
31- The biopsy device according to any one of previous claims characterised in that the said biopsy mechanism further integrates at least one resonator to perform frequency characterization of the said biopsy mechanism or to enhance magnetic resonance imaging resolution .
32- The biopsy device according to any one of the previous claims wherein said biopsy mechanism
comprised of a first insulating material, and a passive resonance circuit having an inductor, a capacitor, and optionally a resistor, wherein:
(a) said first insulating material is disposed on said inductor, wherein said first insulating material is biocompatible and forms an impermeable barrier around said inductor; and
(b) the resonance frequency of said circuit or said portion corresponds substantially to a resonance frequency of a rotational frequency of the magnetic field applied by a magnetic resonance system. The said biopsy mechanism is imageable by the magnetic
resonance system.
33- A medical device characterized in that it comprises at least one actuator, at least one tissue sampling mechanism such that at least one biosensor is integrated in the said tissue sampling mechanism, said device being equipped to perform in vivo analysis and extract information about the captured tissue
especially the characterization of the malignancy of captured tissue. 34- A biopsy device according to anyone of previous claim wherein the said biopsy device further comprising circuitry that senses hand movements, the circuitry including at least two gyroscopic sensors including a first sensor that senses pitch and a second sensor that senses yaw, and the circuitry including a transmitter that transmits data
corresponding to the sensed movement to a host system coupled to the said biopsy device.
35- The biopsy device of claim 35 wherein the said device includes an enable switch, and wherein the circuitry transmits the data corresponding to the sensed movement only when the enable switch is actuated .
36- The biopsy device of claim 36 wherein the enable switch comprises a capacitive proximity sensor that is actuated when the user's hand is closed.
37- The biopsy device of claim 36 wherein the enable switch comprises a mechanical button that is actuated when depressed.
38- The biopsy device of claims 35 to 38 wherein further comprises a third gyroscopic sensor that senses roll, one or more linear accelerometers , and/or one or more magnetometers.
39- Installation of imaging-guided biopsy, wherein the both biopsy device and imaging probe comprise specific circuitry that senses physician hand movements, each circuitry including at least two gyroscopic sensors including a first sensor that senses pitch and a second sensor that senses yaw, and each circuitry including a transmitter that transmits data corresponding to the sensed movement to a host computing system coupled to the devices.
40- A biopsy device according to anyone of previous claims such that said biopsy mechanism integrates targeted contrast agent as dyes and/or targeted ultrasound microsphere.
41- Installation of imaging guided biopsy wherein A biopsy device according to claim 40 characterized by the said biopsy mechanism comprises a plurality of microspheres with various diameters.
42- A biopsy device according to anyone of previous claims such that said biopsy mechanism integrates at least one optical fibre.
43- A biopsy device according to anyone of previous claims wherein the said biopsy mechanism further comprises at least one magnet element and at least one radiofrequency coil such that in vivo magnetic resonance spectroscopy can be operated for tissue analysis.
44- A biopsy device according to anyone of previous claims wherein the said biopsy mechanism further comprises at least one atomic magnetometer to perform in vivo NMR spectroscopy.
45- A biopsy device according to anyone of previous claims such that the said device is wireless.
46- A biopsy device according to anyone of previous claims such that the said device is used for breast cancer biopsy.
47- A biopsy device according to anyone of previous claims such that the said device is used for cervix cancer biopsy. 48- A biopsy device according to anyone of previous claims such that the said device is used for lung cancer biopsy.
49- A biopsy device according to anyone of previous claims such that the said device is used for lymph node cancer biopsy.
50- A biopsy device according to anyone of previous claims such that the said device is used for kidney cancer biopsy.
51- A biopsy device according to anyone of previous claims such that the said device is used for liver cancer biopsy.
52- A biopsy device according to anyone of previous claims such that the said device is used for pancreas cancer biopsy.
53- A biopsy device according to anyone of previous claims such that the said device is used for biopsy in dermatology.
54- A biopsy device according to anyone of previous claims such that the said device is used for biopsy in neurology.
55- A biopsy device according to anyone of previous claims such that the said device is used for biopsy in cardiology.
56- A medical device comprising:
a. a housing
b. at least one drug delivery mechanism moveably connected to said housing and comprising at least one longitudinal profiled element and at least one chamber c . at least one actuator for moving said drug delivery mechanism outward relative to said housing and for operating said drug delivery mechanism such that axial movement and/or rotation around the main axis of said element are generated directly or
indirectly from at least one said actuator and such that said drug delivery mechanism is disposable.
57- A method of identifying a region within a tissue portion having a different diffusivity than the surrounding tissue of the tissue portion comprising: causing a deformation of the tissue portion;
determining at least one of the properties of wave speed and wave attenuation in the tissue when the tissue portion is deformed to yield a pattern of the property of wave speed or wave attenuation in the tissue; evaluating the pattern of at least one of the properties of wave speed and wave attenuation in the tissue to identify a change in the pattern indicating the presence and the location of the differing
diffusivity region of tissue; and calculating the diffusivity characteristics of the tissue portion.
58- . A method of cancer therapy using an
implantable system comprising at least one molecule to deliver inside or in the proximity of the tumor and perform therapy in which an implantable system is positioned by a device with automation means for the moving and the extraction of the said implantable system inside the patient's body.
59- A method of cancer therapy according to claim 58 in which the implantable system is composed with bio-absorbable materials.
60- A method of cancer therapy according to claim 59 in which the implantable system is an active gel integrating relevant molecules and delivering with adequate kinetic the molecule to the relevant tissue area .
61- A method of cancer therapy according to claim 60 in which the delivery of molecule (s) from the implantable system is actuated by magnetic means.
62- A biopsy device according to anyone of previous claims such that the said device is used for laparoscopy .
63- A biopsy device according to anyone of previous claims such that the said device is used for endoscopy .
PCT/IB2009/055749 2009-12-15 2009-12-15 Handheld automated biopsy device WO2011073725A1 (en)

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