WO2010047678A1 - Sonde à ultrasons polyvalente et procédé pour son utilisation - Google Patents

Sonde à ultrasons polyvalente et procédé pour son utilisation Download PDF

Info

Publication number
WO2010047678A1
WO2010047678A1 PCT/US2008/012110 US2008012110W WO2010047678A1 WO 2010047678 A1 WO2010047678 A1 WO 2010047678A1 US 2008012110 W US2008012110 W US 2008012110W WO 2010047678 A1 WO2010047678 A1 WO 2010047678A1
Authority
WO
WIPO (PCT)
Prior art keywords
probe
assembly
finger
sensor
connector
Prior art date
Application number
PCT/US2008/012110
Other languages
English (en)
Inventor
Ronald W. Schutz
Scott S. Corbett
Kenneth N. Bates
William Mcdonough
Albert H. Krause, Jr.
Original Assignee
Blacktoe Medical Iii, Inc.
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 Blacktoe Medical Iii, Inc. filed Critical Blacktoe Medical Iii, Inc.
Priority to PCT/US2008/012110 priority Critical patent/WO2010047678A1/fr
Publication of WO2010047678A1 publication Critical patent/WO2010047678A1/fr

Links

Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/12—Diagnosis using ultrasonic, sonic or infrasonic waves in body cavities or body tracts, e.g. by using catheters
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B90/00—Instruments, 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
    • A61B90/50—Supports for surgical instruments, e.g. articulated arms
    • A61B90/53—Supports for surgical instruments, e.g. articulated arms connected to the surgeon's body, e.g. by a belt
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/01—Measuring temperature of body parts ; Diagnostic temperature sensing, e.g. for malignant or inflamed tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/03—Detecting, measuring or recording fluid pressure within the body other than blood pressure, e.g. cerebral pressure; Measuring pressure in body tissues or organs
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B5/00—Measuring for diagnostic purposes; Identification of persons
    • A61B5/145—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue
    • A61B5/14532—Measuring characteristics of blood in vivo, e.g. gas concentration, pH value; Measuring characteristics of body fluids or tissues, e.g. interstitial fluid, cerebral tissue for measuring glucose, e.g. by tissue impedance measurement
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/44—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device
    • A61B8/4444—Constructional features of the ultrasonic, sonic or infrasonic diagnostic device related to the probe
    • A61B8/4472—Wireless probes
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61N—ELECTROTHERAPY; MAGNETOTHERAPY; RADIATION THERAPY; ULTRASOUND THERAPY
    • A61N7/00—Ultrasound therapy

Definitions

  • the present disclosure relates to an ultrasound probe for medical use, and relates more particularly to such a probe that can be manipulated periodically at the location of a procedure being carried out in a sterile surgical field.
  • Another problem is the disassociation, both in time and location, of the tactile input that a medical professional receives from his fingers, during a procedure, and the ultrasound imagery data.
  • a medical procedure must be interrupted for imaging to occur, it may be quite difficult for the surgeon to match the tactile information that he notes with the imagery previously acquired.
  • diagnostic procedures it may be impossible for the medical professional to gain both tactile information and image information simultaneously.
  • the task of remembering and piecing together the two types of data presents an additional challenge to the medical professional.
  • a problem faced specifically by cardiothoracic surgeons is that of assessing plaque deposits in a portion of the aortal arch and ascending aorta prior to accessing that portion of the aorta surgically. If there are plaque deposits in a part of the aorta being accessed, the deposit or a portion of it may break off, travel through the blood stream and lodge in a blood vessel, causing great damage to tissue that is dependent on the vessel for its blood supply.
  • Doppler ultrasound probes are currently used for the assessment of plaque deposits in the aortal arch and ascending aorta
  • intra-operative probes for accessing interior portions of the body are about 10 cm long and rigid. Although this form is potentially useful in some situations, it greatly complicates the task of successfully placing the probe for imaging a blood vessel and for many other intra-operative situations, while permitting the user to maintain a correct sense for the orientation and position of the probe transducer.
  • the entire sensor and cable assembly is rather bulky for fitting into a bath of disinfecting liquid, and the connector is typically not designed to be immersed in disinfectant. As a result, achieving satisfactory sterility of the probe and cable assembly can present a challenge to hospital personnel.
  • finger-mounted probes are currently known, they are typically either bulky and inflexible or they do not form desirably precise images.
  • a finger-mounted ultrasound probe assembly includes an ultrasound probe adapted to be mounted on a finger and a flexible multi- conductor cable attached to the ultrasound probe.
  • the ultrasound probe may include transducer elements capable of providing therapeutic ultrasound transmission.
  • an arm unit is connected to the multi-conductor cable and includes a mounting to bind the arm unit to a user's arm. Also, the ultrasound probe and the arm unit are adapted to mate with each other so that the ultrasound probe may be engaged to and retained by the forearm unit, to stow the ultrasound probe when not in immediate use.
  • an image sensor assembly includes an imaging station assembly, including an imaging station and a station multi-conductor cable assembly connected to the imaging station and terminating in a station-side probe connector-half. Also, a probe assembly has an image-sensor probe and a probe multi-conductor cable assembly, terminating on a first end in a probe-side probe connector-half adapted to mate to the station-side probe connector- half.
  • the station multi-conductor cable assembly is connected to a forearm of the user and the probe-side probe connector-half is connected to the station-side probe connector-half.
  • the probe is then used to examine a subject.
  • the finger-mounted probe is small, light in weight, and shaped to be moved easily through small surgically created openings or in naturally occurring bodily orifices.
  • an embodiment of the disclosed apparatus may include a finger-mounted sensor assembly having a finger-mounted sensor and an electrical connective assembly adapted to connect the finger sensor to a display station. Also, an arm mount unit is adapted to be mounted on a user's forearm, and an electrical connective subassembly extends from the arm mount unit to the sensor.
  • the electrical connective subassembly in one embodiment is ribbon-like and no thicker than 2.5 mm.
  • one embodiment of the disclosed apparatus may include a finger-mounted sensor assembly that includes a piece of flex circuit having a first end and a second end and that is more than 5 cm long from the first end to the second end.
  • An ultrasound transducer may be located on the two centimeters of the piece of flex circuit nearest the first end and electrical conductors for the ultrasound transducer may reside in the flex circuit and extend toward the second end.
  • optical sensors may be associated with the ultrasound probe so as to provide additional information to a medical professional, or tools may be associated with the ultrasound probe so that use of such tools may be guided using images developed by the ultrasound probe.
  • FIG. 1 is a perspective view of an ultrasound imaging assembly embodying the present invention, shown in its environment, with a probe assembly attached to a medical professional and ready for use.
  • FIG. 2 is a perspective view of the probe assembly shown in FIG. 1 , in use on a patient.
  • FIG. 3 is a perspective view of an alternative embodiment of the probe assembly shown in HG. 1, showing a wireless link to an imaging station.
  • FIG. 4 is a perspective view of the assembly of FIG. 1 , showing a probe retaining clasp in use.
  • FIG. 5A is a perspective view of a work piece representing a first step in a process for manufacturing the finger-mounted probe that is part of the assembly shown in FIG. 1.
  • FIG. 5B is a perspective view of a work piece representing a second step in a process for manufacturing the finger-mounted probe that is part of the assembly shown in FIG. 1.
  • FIG. 5C is a perspective view of a work piece representing a further step in a process for manufacturing the finger-mounted probe that is part of the assembly shown in FIG. 1.
  • FIG. 5D is an exploded perspective view showing the manner of assembling a finger- mounted probe having an alternative structure.
  • FIG. 6 is a perspective view of a finger-mounted probe similar to that shown in FIG. 1 , showing navigational elements.
  • FIG. 7 is a perspective view of an alternative finger-mounted probe having a hypodermic needle attached to it.
  • FIG. 8 is a perspective view of another alternative finger-mounted probe having an electric camera attached to it.
  • FIG. 9 is a perspective view of a further alternative finger-mounted probe having a set of sensors attached to it.
  • FIG. 10 is a perspective view of an alternative finger-mounted probe including an attached set of controls.
  • FIG. 11 is a side view of another finger-mounted probe, showing relevant features of its shape.
  • FIG. 12 is a front view of the probe shown in FIG. 11.
  • an ultrasound imaging assembly 10 includes an imaging station 12, which can include an auxiliary display 13 for the user's convenience. Also, a first multi-conductor electrical cable or display station cable 14 is electrically attached to the imaging station and terminates at a distal connector-half 16.
  • a second, or intermediate, multi- conductor cable 18 extends from a connector-half 20, which may be waist-mounted as shown in FIG. 1, or shoulder-mounted as shown in FIG. 2, and which mates to the distal connector-half 16.
  • the intermediate cable 18 terminates at an arm mount unit such as a forearm band 22 that supports a forearm-mounted connector-half 24.
  • the forearm band 22 may be designed to be mounted where it is most convenient, including on the user's wrist, if desired, but will usually be most convenient and least likely to interfere if located between the wrist and the elbow, and somewhat closer to the elbow.
  • a finger probe sub- assembly 26 includes a finger probe sub-assembly connector-half 28 that mates releasably with the forearm mounted connector-half 24 and may be reconnected easily when desired.
  • a flexible cable 29 in the form of a ribbon extends from connector-half 28 to a finger-mounted probe 30.
  • the forearm mounted connector-half 24 and the finger probe subassembly connector-half 28 may be permanently connected at the arm mount unit.
  • the flexible cable 29 may be an extension of the intermediate cable 18, without connector-halves 24 and 28, and the arm mount unit such as the forearm band 22 may be attached to the cable at a convenient location that would define the extent of the finger probe subassembly.
  • the flexible cable portion 29 may then be interconnected with the finger-mounted probe 30 by a suitable fixed electrical and mechanical interconnection closely adjacent to or within the probe 30.
  • surgery may begin with the surgeon wearing the forearm band 22, which retains the connector-half 24 and intermediate multi-conductor cable 18, which includes the shoulder or waist-mounted connector 20.
  • the surgeon wearing the forearm band 22, which retains the connector-half 24 and intermediate multi-conductor cable 18, which includes the shoulder or waist-mounted connector 20.
  • no finger probe sub-assembly 26 would be attached to the multi-conductor cable 18 and that no station cable 14 would be connected to assembly 18, so that the user would be free to move about freely. This would also permit the surgeon full use of his hands while making an initial incision and performing further preliminary surgical cutting.
  • the surgeon can take a finger-mounted probe sub-assembly 26, that has been kept ready for use, attach it to connector-half 24 and also have the intermediate multi-conductor cable 18 connected to imaging station 12, by way of cable 14 and connector-halves 16 and 20.
  • This procedure might destroy the sterility of the performing person's hands, so it is advisable that a person not otherwise participating in the surgery connect cable 18 to cable 14.
  • a person having sterile hands could briefly don sterile gloves to effect the connection and then doff the gloves after finishing.
  • the cable 14 might be equipped with a sheath which is sterile within and which can be broken away to leave the cable 14 in a sterile condition.
  • the surgeon can then introduce his hand, with the finger-mounted probe 30 attached, into the patient in order to gather ultrasound imagery, as shown in FIG. 2.
  • the finger-mounted probe sub-assembly 26 can be removed from the surgeon's hand and detached from the connector-half 24, to free the surgeon to continue his procedure. Later on, when further imagery is required, either the same sub-assembly 26 may be reattached or another sub-assembly 26, previously maintained in sterility, can be attached to the connector-half 24 and used to perform the further imaging.
  • Various probe configurations are desirably kept at the ready, to provide the surgeon with a variety of image gathering options.
  • This set of finger-mounted probes could vary in transmit frequency, so that a first probe permits detailed imaging of fine structures by using a relatively high frequency (circa 10-20 MHz), and a second, lower resolution, probe permits imaging of deeper structures using a lower ultrasound frequency (circa 2-10 MHz).
  • Probes including transducers of various shapes and architectures are also desirably made available to permit varying fields of view. For example a curved linear array with relatively small radius of curvature permits imaging in the near field of the probe over a wide field of view.
  • a phased array transducer permits imaging over a wide field of view at some distance from the array, while allowing imaging through a narrow access.
  • a linear array permits imaging over a narrower field of view but provides good imaging of structures near the surface of the transducer array. This is frequently the type of imagery that is highly desirable in surgical situations.
  • the use of a linear array of transducer elements in a finger-mounted probe can be particularly advantageous.
  • the probe can be configured so that the linear array images a scan plane that is parallel to the length dimension of the finger, or in another configuration, transverse to the finger. For the parallel configuration a portion of the scan looks forward from the finger, so that if the user directs his finger to point at the body surface, the probe will image a scan plane into the body. The user can then rotate the image plane by twisting his wrist, something that is quite easy for most users to do.
  • the curved surface permits a user to rock the probe on the body or organ surface in order to view tissue over a variety of contact angles. This is particularly easy to do using a finger-mounted probe, as the index finger has a good freedom of movement in several axes.
  • the transversely oriented probe has the advantage that it permits a physician to begin his examination with his hand transverse to the length of the patient's torso, which is a more natural position than parallel to the length of the patient's torso.
  • a straight linear array or a phased array has the advantage that the probe head profile can potentially be minimized, which is very important in accessing body portions.
  • the probe assembly 10 is also very useful in non-surgical procedures, for example, examination of a patient by imaging through the body surface, at the same time the physician is gathering tactile information.
  • the physician may wish to examine a bump or discolored area on the patient's skin and could by use of assembly 10 gather imagery at the same time he touches the abnormal area to diagnose the nature of the problem.
  • the user can make a fuller use of his muscle memory and positional awareness to return the probe head to the same location used in a recent probe use.
  • Imaging assembly 10 may also be used for exploration of body cavities, such as the vagina, rectum or mouth. Again, the user could gain tactile information about an organ such as the prostate gland at the same time also gaining ultrasound image information.
  • a physician may use the imaging assembly 10 to view difficult-to-access areas within the body, during surgery.
  • the surgeon could move the probe 30 around to the posterior of the heart to gain imagery of heart features, such as valves that are difficult to otherwise image. This would be extremely difficult with a rigid probe that is poorly shaped for moving through tissue. A probe without advantageous physical characteristics could easily injure a patient during this type of use.
  • an imaging assembly 10 can be used in a military field hospital to assist a surgeon in the task of removing shrapnel from a wounded soldier.
  • an initial evaluation of the shrapnel locations could be made by an assessment of the entry wounds and pre-surgical imaging, a great deal might still not be known about the specific locations and dimensions of the individual pieces of shrapnel.
  • the surgeon attaches a probe sub-assembly 26 to connector-half 24 and introduces the finger-mounted probe 30 into the incision, to gain a further indication of the shrapnel positions.
  • the surgeon can quickly remove the probe sub-assembly 26 from his finger, so that he can have the full use of both hands in the task of removing pieces of shrapnel identified by the imaging. Later on during the same surgery, the surgeon may wish to take further images and may reattach the probe sub-assembly 26, or some other probe sub-assembly 26, either for the sake of sterility or for the sake of having different imaging characteristics.
  • the low profile of probe 30 lends itself to imaging a premature infant in a neo natal incubator, by reaching through the small entry orifice of the incubator. This action is difficult to perform using previously available ultrasound probes.
  • the ultrasound imaging system 10 described generally above, having cables 14, 18, and probe sub-assembly 26, has advantages both in providing a broad range of connectivity and in easing the task of maintaining a sterile operating theater.
  • the second, or intermediate multi-conductor cable 18 may be sterilized in an autoclave without being damaged. Cable 14 is typically far enough removed from the sterile area so that it need only be wiped down with disinfectant between instances of use.
  • Probe sub-assembly 26 can be submerged in disinfectant fluid for sterilization.
  • the intermediate multi-conductor cable 18 may be protected by a sterile sheath, which can be removed when a physician who is wearing cable 18 needs to move to a different imaging station 12 and use a different probe sub-assembly 26.
  • the flexible cable 29 of the probe sub-assembly 26 is longer, so that the intermediate cable 18 does not have to extend as far toward probe 30, thereby making it more likely for cable 18 to avoid contamination from body fluids.
  • cable 18 may be a universal unit, compatible with a broad range of probe makes, by having the connector-half 24 include a super-set of pins, not all of which are used for any particular finger probe sub-assembly 26.
  • An adapter may be provided that would be interposed between cable 18 and imaging station 12, either where cable 18 connects to cable 14, where cable 14 connects to station 12, or as part of cable 14, to accommodate different types of imaging station 12. It should be noted that this feature of imaging assembly 10 can also be used for ultrasound probes that are not finger probes.
  • a wireless communication link is established between sub-assembly 26 and imaging station 12.
  • a data signal processing and transmission unit 32 receives raw electrical signals from the transducer of the probe 30 and extracts the imagery, thereby greatly reducing the volume of data to be transmitted further.
  • the processed image signal data is transmitted, typically by RF, to imaging station 12 and/or to heads-up display goggles 34, which superimpose the imagery on the user's field of view.
  • the data processing and transmission unit 32 may be located directly on the forearm band 22.
  • a catch 38 may be provided on the forearm band 22, for the purpose of retaining the probe 30, so that it can be folded back, out of the way of the user's hand, when the probe 30 is not in use.
  • the catch 38 may include a system of magnets, with mutually attractive magnets (not shown) on the wrist or arm band 22 and associated with the probe 30.
  • the finger-mounted probe sub-assembly 26 may be made primarily of molded light weight plastics materials and in one embodiment has a mass of less than 70 grams. Depending on the mass of the probe 30, the length and the number of conductors included in the multi- conductor cable 29, and the specifics of the structure of the finger-mounted probe sub-assembly connector-half 28, the mass of the finger-mounted probe sub-assembly 26 is preferably no more than 280 grams, more desirably not more than 140 grams, and even more desirably not more than 80 or 100 grams.
  • the distal 3 cm of finger-mounted probe 30, which includes the ultrasound transducer 56 and absorptive backing 54, and possibly a lens 63, in a housing 62, desirably has a mass of not more than about 100 grams, although, depending on the factors including the number of transducer elements 58, the transmission frequency and the type of transducer materials the mass may advantageously be as little as 50 grams, 30 grams, 20 grams, 15 grams, or even 1 1 grams. This low mass is very convenient in enabling a user to easily maneuver the finger-mounted probe 30.
  • flex circuit is a term of art in the electronic device industry, referring to an electrically connective element made of a sheet of flexible polymeric dielectric material having conductive traces formed on it by, for example, photolithographic techniques.
  • a flex circuit may be sealed with an additional sheet of polymeric material, so that the conductive traces are interposed and sealed between two flexible sheets.
  • construction of the finger-mounted probe sub-assembly 26 begins with the creation of a T-shaped piece of flex circuit 40, shown in a simplified form in FIGS. 5 A, 5B, and 5C.
  • two or more L-shaped pieces such as pieces 41a, 41b, 41c, and 41d are overlapped or placed side-to-side to form a T shape.
  • the length 46 between a proximal end 42 and a distal end 43, of flex circuit 40 may be, for example, 25 cm.
  • the length 48 of the T-shape top bar at distal end 43 may conveniently be about 7.0 cm.
  • the distal end T-shaped top bar includes a first branch 44 and a second branch 45.
  • Each of several conductive traces 50 turns at the T-junction and extends from proximal end 42 to the end of either branch 44 or 45. While for illustrative clarity only 7 conductive traces 50 are shown in each branch 44 or 45, a larger number, such as 32 separate parallel traces 50 may be included in a layer of the flex circuit 40, and more than one layer, for example 4 layers, as shown in FIG. 5D, or as many as 8 layers, may be included.
  • a set of bare trace ends 53 are formed at the free ends of branches 44 and 45 by removing the end of the plastic of flex circuit 40 from about traces 50, typically by laser ablation.
  • Each of several flex circuit layers may typically have a thickness of only 0.3 mm, so a cable 29 of 8 flex circuit layers can still be conveniently flexible and have a small thickness 57 of no more than about 2.5 mm.
  • the ribbon- like cable 29 may have a width 59, depending on the number and size of the traces 50, in the range of 1 -2 cm.
  • An ultrasound transducer 56 is formed by connecting the trace ends 53 to respective transducer elements 58 such as pieces of piezoelectric material arrayed along side one another, shown in a reduced number for the sake of clarity in FIGS. 5C and 5D.
  • the trace ends 53 may be interdigitated and connected to alternately located elements 58 from the two sides of the transducer 56.
  • a high performance acoustically absorptive backing material 54 is affixed behind the piezoelectric transducer, so that trace ends 53 are encapsulated between backing material 54 and piezoelectric material.
  • Backing material 54 may be as disclosed in U.S.
  • a backing material having an acoustic absorbance equal to or greater than 60 db/MHz/cm is disclosed.
  • such a probe could be modified by creating a toothed pattern, such as that found on the sides of an anechoic chamber, in the surface of the backing material that faces away from the ultrasound array. This causes the sound waves reflecting off the rear of the ultrasound array stack to scatter.
  • the elements 58 of piezoelectric material 56 of the ultrasound transducer may be arrayed, as shown in a simplified view in FIG. 5C, with each transducer element 58 being connected to a unique trace 53 and to a common ground plane bus (not shown).
  • a conveniently located set of ultrasound elements 58 may be connected to trace ends 53 of branch 44, while another set of transducer elements 58 are connected to trace ends 53 of branch 45.
  • L-shaped pieces 41a and 41b of flex circuit 40 are used, rather than a single T-shaped piece, permits the step of connecting bare traces 53 to piezoelectric transducer elements 58 to be performed with the L-shaped pieces 41a and 41b of flex circuit laying flat, as shown in FIG. 5D, thereby greatly easing this connective task.
  • the lateral branches 44 and 45, respectively, of L-shaped pieces 41a and 41b may then be curled up and the longitudinal portions may be interleaved and overlapped at the top, thereby forming an annulus that fits about the finger at the end of a multi-layer flex circuit cable 29.
  • the branches 44 and 45 are flexed arcuately to form a ring 60 that can fit about a user's finger, so that ultrasound transducer array faces downwardly, or outwardly, with the piezoelectric elements 58 arranged and oriented conveniently to sweep forward or backward relative to the finger.
  • a housing 62 possibly including an ultrasound lens 63, may be molded about the ring 60 that is formed by flex circuit branches 44 and 45, legs 41a and 41b, and materials 54 and 56, to arrive at a final configuration of a finger-mounted probe 30, various possible versions of which are shown in FIGS. 7-10.
  • the housing 62 may be made by molding
  • a protective coating may also be added to the medial portion 64 of flex circuit 40.
  • a probe 30 constructed according to the preferred methods described herein may have a distance 312, from the interior surface 324 of the finger mount to the furthest protrusion of the transducer and lens, of about 1.2 cm, greatly facilitating a user in passing the probe 30 through small passages in the body. In another embodiment distance 312 may equal about 1.5 cm.
  • probe 30 is made, in one embodiment of the finger probe sub-assembly 26, so that the ultrasound transducer 30 protrudes outwardly with its front and rear end tapered from the middle, defining an angle 314 between a probe surface that extends parallel to the user's finger and the sloped surface of the front of the probe as it begins to protrude outwardly.
  • Angle 314 is ideally about 70° at its maximum. In an alternative preferred embodiment, angle 314 is about 60° at its maximum and in yet another preferred embodiment, this angle is about 50° at its maximum. In yet another preferred embodiment, angle 314 is about 40°.
  • An additional angle 316 may be defined as the angle between a probe surface that extends parallel to the user's finger and the surface of the rear of the probe as it begins to extend outwardly, going from rear to front. It is also desirable to minimize angle 316, so that as the probe is being removed back through tissue, it disturbs the tissue as little as possible. In a preferred embodiment this angle is about 40°. In other embodiments this angle ranges from 40° to 70°.
  • a finger cot 320 may be used both to isolate the front of the user's finger from a patient's tissue, and to provide a rounded surface, at the front of the finger, which can be pushed through tissue with less chance of causing damage.
  • a probe unit 310 having a fixed inner diameter 324 can accommodate a range of finger thicknesses, by being used with cots having a range of different thicknesses. It is desirable to minimize the distance 318 between finger cot 320 and probe surface 322. Although this distance 318 is shown as being on the order of 2 mm, in another embodiment distance 318 is zero, with the finger cot 320 being flush with the probe surface.
  • This low and sloping profile and gradual protrusion greatly facilitates a probe user in inserting the probe into small body cavities and avoiding damage to delicate tissues.
  • a "bullet shaped" probe that comes to a point forward of the finger and smoothly expands to the area where the transponder is located. This can be accomplished by equipping the probe with a forward section that terminates distal to the finger tip in a single point and expands transversely outwardly approximately equally and smoothly in each direction, to yield the bullet shape.
  • a 128-element probe is constructed and in an alternative preferred embodiment a 256-element probe is constructed.
  • a linear array is shown, a curved linear array could be constructed just as easily, using the techniques shown, simply by curving the array of piezoelectric elements 58.
  • a separately formed ultrasound transducer is connected to flex circuit 40 by way of a flex circuit connective tab.
  • flex circuit 40 rather than terminating in connector-half 24, can be terminated by connection to a multi-conductor coaxial cable, of the type that is currently standard in the ultrasound imaging industry, 5 cm or farther away from the probe, with or without a detachable connector.
  • a generally cylindrical multi-conductor coaxial cable terminates quite close to the probe head or in the probe head, causing the finger- mounted portion to be bulky and heavy.
  • the finger probe sub- assembly 26 is kept light and given a low profile. Accordingly, the present invention does not require inclusion of system connectors that although advantageous do not by themselves yield the low profile of the finger-mounted probe sub-assembly 26.
  • traces 50 are connected a capacitive micro machined ultrasound transceiver (CMUT), using the same techniques as used for connecting them to the elements 58 of piezoelectric material 56.
  • CMUT transceiver tends to be thermally robust, thereby lending itself to use in a probe that may be exposed to the heat and pressure of an autoclave sterilization cycle, without being damaged.
  • a set of electrical contact points 52 are formed by removing the flex circuit plastic down to each trace 50, in a particular spot.
  • Conductive material may be deposited onto contacts 52, so that they are not recessed.
  • a surface coating material covers flex circuit conductive traces 50 so that only connector contacts 52 are left exposed on the surface of flex circuit 40.
  • Rigid backing material 58 may be adhered underneath the flex circuit and a metal housing (not shown) may be provided to finished connector-half 22.
  • the proximal end 42 of the flex circuit 40 can be selectively rigidized by laminating a rigid circuit board material layer onto each flex circuit, and forming connections to the flex traces by laser or mechanical drilling and subsequent plating, to form a monolithic integrated connector assembly.
  • Conventional techniques can be used to interconnect traces 50 of each of several layers of flex circuits 40 to provide an array of contacts 50 on a single plane.
  • a finger-mounted probe assembly 70 may include a set of accelerometers (not shown) and/or inductors 72 that are mounted in a mutually orthogonal pattern as part of finger-mounted probe 70 to permit determination of the orientation and location of the finger-mounted probe 70 within the body.
  • a hypodermic needle 200 and an attached syringe 210 are releasably mounted adjacent a finger-mounted ultrasound probe 30 in a probe assembly 74.
  • Health care professionals sometime need to find a particular blood vessel, such as a jugular vein or a radial vein, in order to inject fluid or drugs as soon as possible so that a substance being injected will reach a target organ as quickly as possible.
  • color flow ultrasound imagery in which Doppler information drives the display of flow in blood vessels and non-Doppler information drives the display for the surrounding tissue, is particularly useful in this endeavor.
  • another sort of skin broaching device such as a canula (not shown) or a hypodermic needle 200 without the syringe 210, but connected through a tube (not shown) to a remotely located intravenous drip bag (not shown) may be mounted on the ultrasound probe 30.
  • Guidance of the hypodermic needle associated with the finger-mounted probe 30 may also be assisted by use of commercially available guidance devices, such as a pressure sensor associated with the needle, including that available from Vascular Technologies, Ness-Ziona, Israel, which provide an additional positive indication when the needle enters a vein, through sensing a pressure change.
  • a probe assembly 76 which is an additional embodiment, shown in FIG. 8, is similar to the finger-mounted probe assemblies described above except that an optical link 260 and light source 262 are provided adjacent the probe 30 to permit optical viewing of body tissue.
  • the optical link 260 may be in the form of a lens coupled to a fiber optic link 264 that may terminate in a video camera (not shown).
  • optical link 260 is in the form of a video camera (as shown) attached to the finger-mounted probe 30 and adapted to communicate electrically with the imaging station 12, or heads up display 34. In either situation it is necessary to provide light for the optical link 260. This may be accomplished either by an electrically powered light source, such as a light emitting diode 262, or a chemically powered light source (not shown), such as those available under the trade name "pin lights,” from Embo- Optics of Beverly, MA.
  • a finger-mounted sensor assembly 78 is equipped with a sensor suite that includes a thermometer 280, an oximeter 282, a pressure sensor 284 and a glucometer 286 mounted on the finger-mounted probe 30.
  • element 286 may be an agent administration patch 286 that is electrically activated by a signal transmitted along a trace 50 to express the agent, thereby administering the agent to a precise location.
  • a different number of sensors, or even only a single sensor may be provided.
  • a finger-mounted sensor assembly 130 can both image tissue, using ultrasound, and also provide therapy, typically by cauterizing tissue, also using ultrasound.
  • a transducer assembly 288 includes both an imaging array 292 and a treatment array 294.
  • the treatment array 294 uses up to 100 watts of power and is powered by flex circuit traces 50 that are larger in cross-sectional dimension and are therefore capable of conducting more current in order to meet the greater power demands of treatment array 294.
  • a single transducer array may be used for both imaging and treatment.
  • some piezoelectric transducer elements 58 are used for both imaging and treatment and others are used solely for imaging. Again, some of the elements 58 of the array must be powered by a larger input of current, and to accommodate this need, the associated flex circuit 40 must include conductor traces 50 of ample size for the transducer current needed for the treatment ultrasound elements.
  • a set of thumb controls 290 are provided for the transducer 288, so that the user may switch between imaging and treatment. These controls are typically in the form of small push buttons that must be pressed in a specific pattern, for example two rapid presses followed by continuous pressure during the period of time treatment is desired, in order to activate treatment mode, as any inadvertent activation could greatly harm a patient.
  • associated power supply circuits could be programmed so that a warning signal is given when two rapid presses have placed the treatment probe in a "ready" state, in case some passage through tissue ever causes two rapid presses to occur.
  • controls are placed on the wrist or forearm band 22, thereby providing easy access for a probe user.
  • buttons 290 may be provided for a probe, such as the probe 30, in which therapeutic ultrasound is not available.
  • the buttons 290 in such a probe may be connected so as to control or change the scan width and orientation, the transmit power and frequency, and the imaging mode, among other aspects of probe operation.
  • the buttons 290 communicate with imaging station 12 by way of traces 50 and cables 18 and 14, or by RF transmission through the data processing and transmitting unit 32, in the embodiment of FIG. 3.
  • the buttons 290 may also communicate or be mechanically associated with the array of transducer elements within the finger probe to allow a change in orientation of the elements to revise the orientation of the scan plane.
  • probe 30 is for the intra-operative evaluation of plaque deposits in the aortal arch and ascending aorta, prior to invasively accessing the aorta.
  • a Doppler probe may be used to obtain a measurement of the speed of the blood in the aorta.
  • the blood flows more rapidly. Reaching the tissue of the aorta is greatly eased by use of a finger- mounted probe 30, as opposed to the long, stiff intra-operative probes previously available.

Landscapes

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

Abstract

L'invention concerne un ensemble (10) d’imagerie ultrasonore doté d’une sonde (30) à ultrasons prévue pour être montée sur un doigt et d’un câble multiconducteur souple (29) rattaché à la sonde à ultrasons. De plus, une unité montée sur le bras est reliée au câble multiconducteur et comprend un connecteur mécanique (22) servant à lier l’unité montée sur le bras à l’avant-bras d’un utilisateur. L’unité montée sur le bras et le câble multiconducteur (29) peuvent comprendre des demi-connecteurs (24,26) respectifs, de telle sorte que la sonde (30) à ultrasons et le câble multiconducteur (29) puissent être séparés de l’unité montée sur le bras. La sonde (30) à ultrasons est petite et légère de façon à pouvoir être utilisée dans des cavités corporelles et à pouvoir être insérée dans des espaces restreints créés chirurgicalement. Des images ultrasonores peuvent être transmises à un poste (12) d’affichage par câble ou par une liaison (32) de communication RF. Des capteurs (72, 260, 280, 282, 286) et des dispositifs (290) de commande supplémentaires peuvent être montés sur la sonde (30) à ultrasons ou associés de près à celle-ci.
PCT/US2008/012110 2008-10-23 2008-10-23 Sonde à ultrasons polyvalente et procédé pour son utilisation WO2010047678A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
PCT/US2008/012110 WO2010047678A1 (fr) 2008-10-23 2008-10-23 Sonde à ultrasons polyvalente et procédé pour son utilisation

Applications Claiming Priority (1)

Application Number Priority Date Filing Date Title
PCT/US2008/012110 WO2010047678A1 (fr) 2008-10-23 2008-10-23 Sonde à ultrasons polyvalente et procédé pour son utilisation

Publications (1)

Publication Number Publication Date
WO2010047678A1 true WO2010047678A1 (fr) 2010-04-29

Family

ID=42119538

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US2008/012110 WO2010047678A1 (fr) 2008-10-23 2008-10-23 Sonde à ultrasons polyvalente et procédé pour son utilisation

Country Status (1)

Country Link
WO (1) WO2010047678A1 (fr)

Cited By (4)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2446825A1 (fr) * 2010-10-28 2012-05-02 Hitachi Aloka Medical, Ltd. Sonde ultrasonique de type insertion de tissu
JP2012090857A (ja) * 2010-10-28 2012-05-17 Hitachi Aloka Medical Ltd 脊椎手術支援用超音波プローブ及びその製造方法
JP2016016157A (ja) * 2014-07-09 2016-02-01 Hoya株式会社 内視鏡のケーブル保持具
WO2017035496A1 (fr) * 2015-08-27 2017-03-02 Tyco Electronics Corporation Ensemble sonde et système comprenant un dispositif modulaire et un ensemble câble

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6290649B1 (en) * 1999-12-21 2001-09-18 General Electric Company Ultrasound position sensing probe
US20040225217A1 (en) * 2003-02-14 2004-11-11 Voegele James W. Fingertip ultrasound medical instrument
US7297115B2 (en) * 2002-11-27 2007-11-20 Black Toe Medical Iii, Inc. Immersible ultrasound probe and cable

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US6290649B1 (en) * 1999-12-21 2001-09-18 General Electric Company Ultrasound position sensing probe
US7297115B2 (en) * 2002-11-27 2007-11-20 Black Toe Medical Iii, Inc. Immersible ultrasound probe and cable
US20040225217A1 (en) * 2003-02-14 2004-11-11 Voegele James W. Fingertip ultrasound medical instrument

Cited By (7)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
EP2446825A1 (fr) * 2010-10-28 2012-05-02 Hitachi Aloka Medical, Ltd. Sonde ultrasonique de type insertion de tissu
JP2012090856A (ja) * 2010-10-28 2012-05-17 Hitachi Aloka Medical Ltd 組織挿入型超音波プローブ
JP2012090857A (ja) * 2010-10-28 2012-05-17 Hitachi Aloka Medical Ltd 脊椎手術支援用超音波プローブ及びその製造方法
US9138201B2 (en) 2010-10-28 2015-09-22 Hitachi Aloka Medical, Ltd. Tissue insertion type ultrasonic probe
JP2016016157A (ja) * 2014-07-09 2016-02-01 Hoya株式会社 内視鏡のケーブル保持具
WO2017035496A1 (fr) * 2015-08-27 2017-03-02 Tyco Electronics Corporation Ensemble sonde et système comprenant un dispositif modulaire et un ensemble câble
IL257694B (en) * 2015-08-27 2022-07-01 Creganna Unlimited Company A device for testing and a system that includes a modular device and a cable assembly

Similar Documents

Publication Publication Date Title
US8211026B2 (en) Finger mounted probe adapted for intraoperative use
KR102617407B1 (ko) 가변성 프로파일 팁을 가진 내시경
JP5833079B2 (ja) 血管内デバイスを誘導し及び位置決めするための装置
JP6138747B2 (ja) 針生検装置
EP3685774A1 (fr) Dispositif médical ayant un appareil de perforation visible
EP2934652B1 (fr) Dispositifs intravasculaires orientables
US7037270B2 (en) Small ultrasound transducers
US20190142373A1 (en) Image guided catheters and methods of use
EP3749214B1 (fr) Dispositifs, systèmes et procédés d'échocardiographie transoesophagienne
AU2019264681B2 (en) Endobronchial ultrasound imaging
CN112842525B (zh) 一种血管内窥镜激光消融导管
US20120323124A1 (en) Probe with dorsal connectivity
US20200359997A1 (en) Wireless operation for transesophageal echocardiography
WO2010047678A1 (fr) Sonde à ultrasons polyvalente et procédé pour son utilisation
JP2009247550A (ja) 内視鏡用処置具及び内視鏡
JP2022554025A (ja) 組織分析、位置決定及び組織切除のためのデバイス、システム及び方法
CN216854796U (zh) 可视化穿刺针式内窥镜
US10856841B1 (en) Ultrasonic imaging probe
WO2023062007A1 (fr) Dispositif montable pour interface de vaisseau sanguin autonome et actionnement d'instrument
CN113288368A (zh) 可视化穿刺针式内窥镜

Legal Events

Date Code Title Description
121 Ep: the epo has been informed by wipo that ep was designated in this application

Ref document number: 08877604

Country of ref document: EP

Kind code of ref document: A1

NENP Non-entry into the national phase

Ref country code: DE

122 Ep: pct application non-entry in european phase

Ref document number: 08877604

Country of ref document: EP

Kind code of ref document: A1