ULTRASOUND IMAGING PROBE

Abstract: A miniature intravascular ultrasonic imaging probe (12) includes a probe guide assembly (14) having an ultrasonic transducer (34) fixed thereto, and internally housed electrical cabling (28) operatively connected to the transducer (34) for sending electrical pulses/signals to/from the transducer (34). The transducer (34) emits/receives ultrasonic waves along a path parallel to the elongate axis of the probe (12). The ultrasonic waves are directed radially of the probe (12) by means of a reflector (44) element which is distally spaced from the transducer (34) along the probe's axis by a dimension sufficient to remove ''dead space'' (i.e., an area where ultrasonic imaging is not possible) radially of the probe (12). An inductor coil (80) (which tunes the transducer to the electrical cabling) is coaxially housed within the probe guide assembly (14) closely adjacent and series connected thereto.

Description: ULTRASOUND IMAGING PROBE FIELD OF THE INVENTION This invention generally relates to ultrasonic intravascular imaging devices — i.e., devices of the type which utilize acoustic transducers operating at ultrasonic frequencies to image intravascular geometry and/or associated tissue characteristics. In a specific embodiment it includes an elongate probe guide assembly, an ultrasonic transducer fixed to the probe guide assembly's distal end, and electrical cabling housed within, and extending proximally of, the probe guide assembly so as to send/receive electrical signals to/from the transducer. This invention effectively reduces "dead space" radially of the probe otherwise obscuring nearby reflections during the normal "ring down" time of a piezoelectric transceiver/transducer immediately after a transmit operation. A reflector is distally spaced from the transducer so as to reflect the ultrasound waves between a first path which is substantially parallel to the probe axis and a second path which is substantially perpendicular (i.e., radial) to the probe axis. A tuning induction coil is electrically connected in series with the transducer and is coaxially positioned within the tube section closely adjacent to the transducer. Such structure permits the ultrasound probes of this invention to be sufficiently miniaturized to be useful in extremely near-field intravascular imaging procedures. BACKGROUND AND SUMMARY OF THE INVENTION Intravascular probes which include ultrasound imaging crystal arrays have been proposed in the past. It is known, for example, to mount a piezoelectric crystal element (conventionally termed a "transducer") on or within a catheter of the type which can be inserted into a blood vessel. Once the probe has been inserted into a blood vessel, the transducer is electro-mechanically excited (as by the application of an electrical signal) to cause emission of ultrasonic energy into the surrounding tissue. While much of the emitted energy is absorbed by the surrounding tissue, a sufficient amount of energy is reflected back toward the transducer to permit imaging (with reflection occurring principally at interfaces between different types of material, e.g., the interface between blood and the vascular wall, the interface between blood and lesions adhered to the vascular wall, etcetera). The transducer, in turn, produces weak electrical signals in response to electro mechanical excitation by the returning reflected ("echo") ultrasonic energy. These weak electrical signals can be used to determine the geometry and/or other characteristics of the blood vessel, for example, to determine whether or not the blood vessel contains lesions or other abnormalities. These determinations are usually termed "imaging" since suitable video and/or other signal monitoring equipment are employed to convert the weak electrical signals produced by the transducer into human-readable form. Information gained from such imaging thus may assist the physician in a vascular treatment in real time or in diagnosing a patient's particular ailment or disease so that suitable therapy can be prescribed. One problem that has plagued conventional ultrasound imaging probes in the past is that an inherent "dead space" usually exists in the immediate vicinity of the transducer. That is, since considerable mechanical excitation (i.e., vibration) of the transducer occurs when ultrasonic energy waves are generated and emitted, it takes some time thereafter for the ringing crystal structure to quit vibrating sufficiently to permit detection of the much weaker echo reflections being returned to the transducer. Once this "dead" time is elapsed, the transducer can begin responding to received echo waves. The time it takes for the transducer to cease its strong electro mechanical transmit vibration (i.e., so that it can then begin sensible electro mechanical vibration in response to weaker echo waves) is sometimes termed the transducer "ring down" time. As can be appreciated, at any given transducer frequency of operation, more or less ring down time will inherently be present so that a region surrounding the transducer is effectively masked -- that is to say, the ring down time creates a "dead space" in the immediate vicinity of the transducer where no imaging is possible. The dimensional extent of such dead space is dependant upon many variables, including the frequency of operation of the transducer. Suffice it to say here that although transducer dead space can be tolerated when relatively large intravascular cavities are imaged (i.e., relative to the size of the imaging probe), significant problems are encountered when small intravascular cavities, such as small diameter blood vessels, etcetera, are to be imaged. And, in any event, transducer dead space mitigates against miniaturization since even the smallest diameter imaging probe is only capable of imaging intravascular cavities outside of its surrounding dead space, thereby providing for an effective imaging area which is usually only significantly greater than the probe's diameter. Another problem which mitigates against imaging probe miniaturization is that the transducer must be "tuned" to the electrical cabling which supplies driving signals to, and returns weaker echo electrical signals from, the transducer. That is, since the transducer, at its frequency of operation, exhibits a net capacitive reactance, inductive reactance should be provided so as to efficiently couple the transmit/receive signals to the transducer (e.g., so as to maximize signal-to-noise ratios) . The present invention, however, provides a miniaturized ultrasonic imaging probe which not only exhibits essentially zero "dead space" (i.e., intravascular imaging can be accomplished in blood vessels having, or capable of being dilated to, substantially the same diameter as the probe itself) but also provides for internal (i.e., as part of the probe per se) inductive reactance. And, the fact that internal inductive reactance may now be provided enhances the ability to use weak electrical echo signals for purposes of diagnostic imaging. These novel features of the invention are achieved by equally novel structure associated with an ultrasonic imaging probe of the type including a probe guide assembly, a transducer connected to the distal end of the probe guide assembly, and electrical cabling housed within the probe guide assembly and operatively connected to the transducer for transmitting electrical power to, and receiving electrical signals from, the transducer. The transducer is mounted within a proximal end portion of a generally cylindrical holder (itself being attached to the distal end of the probe guide assembly) which defines an elongate, open trough. Thus, the transducer is also mounted near the proximal end of the trough. An ultrasound reflector (e.g., polished stainless steel) is mounted at the distal end of the holder (i.e., at the distal end of the defined trough) in axially spaced relation to the transducer for directing ultrasonic energy waves between a first path (which is substantially parallel to the elongate axis of the probe) to a second path (which is substantially perpendicular to the elongate axis of the probe). Thus, ultrasonic energy waves emitted from the transducer along the probe's elongate axis will be redirected radially of the probe by means of the reflector towards the surrounding tissue being imaged. Echo waves which radially return from the surrounding tissue will likewise be redirected by means of the reflector axially of the probe towards the transducer. The distance that the reflector is axially spaced from the transducer is selected such that the "dead space" lies substantially therebetween. Thus, since the dead space for any given transducer will lie axially between the transducer and the reflector, intravascular imaging immediately radially adjacent the external periphery of the probe is possible. That is, as long as the probe is of a size which is capable of being moved within intravascular tissue or organs, then imaging of such tissue or organs is possible. The probe of the invention is also provided with an inductor coil as the inductive reactance, the inductor coil being coaxially housed within the probe guide assembly and positioned closely adjacent the transducer. Preferably, the electrical cabling of the invention is a standard coaxial cable having an inner conductor (with an associated insulating layer) and an annular outer conductor (with an associated insulating layer) . According to this invention, a distal end segment of the outer conductor (and its associated insulating layer) is removed. The inductor coil is then coaxially positioned over the inner conductor (and its associated insulating layer) in the space previously occupied by the removed outer conductor segment. The proximal end of the inductor coil is thus connected to the distal end of the remaining outer conductor while the distal end of the inductor coil is connected electrically to the transducer. The inner conductor, on the other hand, is connected electrically to the transducer at a location different from the connection of the inductor coil (preferably at a location on the front face of the transducer) . In such a manner, the transducer and inductor coil are connected closely adjacent, and in series relationship, to one another. These as well as other objects and advantages of the invention will become apparent after careful consideration is given to the following detailed description of the presently preferred exemplary embodiments. BRIEF DESCRIPTION OF THE ACCOMPANYING DRAWINGS Reference will hereinafter be made to the accompanying drawings wherein like reference numerals throughout the various FIGURES denote like structural elements, and wherein; FIGURE 1 is a schematic diagram of an exemplary ultrasound imaging system with which the ultrasound imaging probe of this invention is used; FIGURE 2 is a perspective view, partly in section, of the ultrasound imaging probe of this invention; and FIGURE 3 is an axial cross-sectional view of the imaging probe shown in FIGURE 2 taken along line 3-3 therein. DETAILED DESCRIPTION OF THE PREFERRED EXEMPLARY EMBODIMENT A schematic diagram of an exemplary ultrasound imaging system 10 is shown in accompanying FIGURE 1. System 10 generally includes an ultrasound imaging probe 12 (which will be described in greater detail below) generally comprised of proximal probe guide assembly 14, an ultrasound "bullet" 16 (i.e., structure which includes the ultrasound transducer), and a distal guidewire assembly 18. A visual position indicator and rotation knob 20 are operatively associated with the probe 12 so as to assist the physician in his/her intravascular manipulation and positioning of the bullet 16. .An ultrasound transmitter/receiver 24 is connected to a preamplifier 26 via standard coaxial cable 28. The transmitter/receiver 24 is of a conventional type in that it produces a pulse signal (of a desired magnitude and shape) which is applied via cable 28 and preamplifier 26 to excite an electroacoustic transducer housed within bullet 16. The receiver portion of transmitter/receiver 24 performs conventional signal processing operations (e.g., amplification, noise reduction and the like) on electrical signals generated by electro mechanical excitation of the transducer within bullet 16 (i.e., signals generated by the transducer in response to receiving echo waves), which signals have been amplified via preamplifier 26. These processed signals are then supplied as an input to a CRT 20 monitor (or any other equivalent display device) so as to generate an ultrasound image 30 representative of the vascular structures reflecting ultrasonic energy toward the transducer within bullet 16 using, for example, conventional PPI (radar) algorithms. The imaging probe 12 of this invention is shown more clearly in accompanying FIGURES 2 and 3 in a greatly enlarged manner for clarity of presentation. For example, although the probe 12 can be of any desired length, it preferably is fabricated to a length of about 60 inches having a nominal diameter of about .0038 inch. As is seen, the probe guide assembly 14 is currently comprised of a coaxial cable 28 housed within the lumen 32 (see FIGURE 3) of a tube section 33 so as to transmit electrical pulses to, and return electrical signals from, the transducer 34 housed within the bullet 16. The bullet 16 is itself comprised of a one-piece holder 36 which defines an axially elongate open trough 38. The holder 36 thus houses the transducer 34 within its proximal end so that the front face 40 of transducer 34 extends slightly beyond the proximal end 42 of trough 38. The other, distal end of holder 36 houses an acoustic reflector 44 (whose functions will be described in greater detail below) which in the preferred embodiment shown, defines a beveled planar surface 46 oriented at an angle (e.g., 45°) relative to the longitudinal axis 48 of probe 12. The surface 46 of reflector 44 may, however, be concave, particularly if convergent focussing of emitted/returned echo waves is desired. In either case, the angular orientation of surface 46 with respect to a transverse plane may be greater/lesser than 45° so as to project the reflected acoustic waves in a proximal/distal direction, respectively. The acoustic reflector 44 and holder 36 are each preferably fabricated from stainless steel and are rigidly coupled to one another via soldering, welding or like techniques. The transducer 34, on the other hand, is rigidly maintained within holder 36 via a suitable biocompatible adhesive. The positions of transducer 34 and reflector 44 within holder 36 could, however, be reversed from that shown in the accompanying FIGURES, if desired. Thus, transducer 34 could occupy the distal end of holder 36 while reflector 44 could occupy the proximal end of holder 36. Preferably, the open trough 38 is filled with a solid acoustic couplant 49 which is shown only in FIGURE 3 for clarity of presentation. Acoustic couplant 49 can be any suitable minimally acoustic-absorbant polymer material such as low density polyethlene, polyurethane, and the like. Couplant 49 thus exhibits an acoustic impedence which is closely matched to that of transducer 34 and the patient's blood. The acoustic couplant 49 also presents an overall smooth cylindrical exterior surface to holder 36 which is beneficial since the holder 36 may then be more easily manipulated within a patient's arterial tissue. Because it fills the trough 38, the acousic couplant 49 prevents blood from pooling and clotting within holder 36, which clotting could cause patient thrombosis. The distal guidewire assembly 18 is comprised of a coiled guidewire 50 (e.g., formed from about .003 in. diameter wire and tightly coiled to an outside diameter of about .038 in.) having its proximal end 50a rigidly coupled to the holder/reflector 36/44 as by soldering, welding or the like. A tip 52 of a noble metal (e.g., gold, platinum or the like) is formed by brazing, welding, or like techniques so as to embed the distal end 50b of guidewire 50. Tip 52 presents a smooth convex surface to more easily facilitate intravascular maneuvering. Also, since the tip 52 is formed of a noble metal, it is visible when fluoroscopic techniques are employed. The tip 52 also embeds the distal end of a continuous safety ribbon 54. The proximate end of ribbon 54 is soldered or welded rigidly to an axially bevelled surface 56 of a generally cylindrical, distally extending boss 58 integral with reflector 44. The ribbon 54 thus provides an added measure of safety to ensure that the assembly 18 will not inadvertently become separated from the catheter 12 during use. The proximal end of holder 36 is rigidly connected to the distal end of tube section 33 via a "trumpet-shaped" connecting region 60. That is, the tube section 33 includes an outwardly (i.e., in the distal direction) flared region 62 coupled to the interior of an inwardly (i.e., in a proximal direction) tapered region 64 of the holder 36. The region 64 thus surrounds and is rigidly coupled (as by soldering, welding, or the like) to the region 62 so as to prevent separation of the holder 36 and tube section 33 during intravascular manipulations. Preferably, the tube section 33 is formed of stainless steel and dimensioned so as to be about six (6) inches in length and have about a .028 in. outside diameter and about a .023 in. inside diameter. Thus, the tube section 33 is thin-walled (e.g., about .0025 in. thick) such that it is flexible (bendable) relative to the catheter axis 48. " The tube section 33 is surrounded by another coiled guide wire 66 and extends proximally beyond the axial length of tube section 33 (i.e., to the exterior of the patient so as to permit guide wire 66 functions to support tube 33 (i.e., so as to provide increased strength) so as to prevent kinks from forming in the otherwise thin-walled tube 33 when it is manipulated during intravascular imaging. By way of example, the guide wire 66 is formed of a tightly coiled wire approximately .005 in. in diameter so that the resulting inside diameter of the coil is about .0028 inch. As is best seen in FIGURE 3, the coaxial cable 28 is of a conventional type in that it includes a center conductor 70 (and its associated insulating layer 72) and an annular (i.e., braided shield) outer conductor 74 (and its associated outer insulating layer 76). The inner and outer conductors are preferably copper, but other electrically conductive materials may be employed provided that the impedance of the cable is sufficient for purposes of ultrasound imaging. In this regard, the coaxial cable 28, in the preferred embodiment, will exhibit an impedance of about 25 or 50 ohms. A distal segment 78 (see FIGURE 3) of the outer conductor/insulating layer 74/76 is removed according to this invention and, in its place, an inductor coil 80 is positioned coaxially surrounding the underlying inner conductor/insulating layer 70/72. The proximal end of inductor coil 80 is electrically connected to the terminal end of the outer conductor 76 while the other distal end of inductor coil 80 is electrically connected via a soldered flat copper ribbon 81 (about .01 in. wide by .001 in. thick) to the peripheral exterior surface of transducer 34 (or at any other suitable location) . The terminal end of the center conductor 70, on the other hand, is electrically coupled via a soldered flat copper ribbon 82 (similar to ribbon 81), to the front face 40 of transducer 34 (i.e., at a location different from that of the electrical connection of ribbon 81, and hence coil 80). The inductor coil 80 is therefore series-connected to the transducer 34. The particular characteristics.of coil 80 are chosen so as to "tune" the signal carrying capability of cable 28 to the operating characteristics of the transducer 34. That is, the wire diameter, coil size, number of turns, etcetera, are selected so that the overall performance of the inductor coil 80 is such that it exhibits an inductive reactance which is substantially equivalent to the net capacitive reactance of the transducer 34 at its operating frequency. In the preferred embodiment, coil 80 will be formed of about .005 in. diameter single strand, ML (DuPont™) coated copper wire and coiled to an outside diameter of about .020 in. and a length of about 2.8 inches. Such an inductor coil will exhibit an inductive reactance of about 100 ohms at 20 MHz (i.e., an inductance of about one microHenry) . Since the inductor coil 80 is located closely adjacent the transducer 34, an effectively increased signal to noise ratio results with the benefit being that higher quality imaging signals are transmitted into the receiver portion of the transmitter/receiver 24. In use, the probe 12 is intravascularly inserted into a patient. For example, if the catheter 12 is to be used so as to image a patient's coronary arteries, then it may conveniently be inserted percutaneously into the patient's femoral artery. The catheter 12 is then maneuvered by the physician until a desired region of the patient's coronary arteries is adjacent the bullet 16, such maneuvering being aided by the position indicator and rotation knob 20 (see FIGURE 1) in addition to the fluoroscopically visible tip 52 (i.e., if fluoroscopic imaging techniques are also employed) . With the bullet 16 properly positioned, ultrasound imaging of the adjacent arterial tissue may be accomplished conventionally by sending electrical pulses to and receiving electrical signals from, transducer 34 as has been previously described. The transmission of ultrasound waves to/from transducer 34 may be aided by the presence of blood and/or other body fluids in trough 38, which fluids serve to acoustically couple the transducer 34 and reflector 44. Also, the "dead space" (i.e., that region in advance of the transducer 34 in which no imaging is possible) will be located substantially in that area between the transducer 34 and the reflector 44 and hence ultrasound imaging of the surrounding arterial tissue within a minimum imaging region established by the exterior periphery of the holder 36 is possible. While the invention has been described in connection with what is presently considered to be the most practical and preferred embodiment, it is to be understood that the invention is not to be limited to the disclosed embodiment, but on the contrary, is intended to cover various modifications and equivalent arrangements included within the spirit and scope of the appended claims.

Claims: WHAT IS CLAIMED IS: 1. An ultrasonic imaging probe (12) comprising: an elongate probe guide assembly (14); transducer means (34) connected near a distal end of said probe guide assembly (14) for transmitting/receiving ultrasonic waves; and electrical cable means (28) housed within said probe guide assembly and operatively connected to said transducer means (34) for transmitting electrical signals to, and receiving electrical signals from, ' said transducer means; said electrical cable means (28) including an inductor coil (80) coaxially housed within said probe guide assembly (14) and positioned closely adjacent said transducer means (34) and connected therewith. 2. An ultrasonic imaging probe as in claim 1 wherein a distal end of said coil (80) is connected to said transducer means (34) and wherein said electrical cable means (28) includes at least a two lead cable (70, 76), one of said leads (76) of said cable being electrically connected to a proximal end of said inductor coil (80) and another of said leads (70) of said cable being electrically connected to said transducer means (34) at a location different from.said electrical connection of said inductor coil distal end. 3. An ultrasonic imaging probe (12) comprising: a probe guide (14); a holder (36); an ultrasonic transducer (34) mounted within said holder (36); means (33, 62, 64) for connecting said holder (36) to an axially distal end of said probe guide (12); and electrical cable means (28) positioned within said probe guide (12) for transmitting electrical signals to/from said transducer (34), wherein said means for connecting includes; (i) a tube section (33); (ii) an outwardly flared region (62) formed at a distal end of said tube section; and (iii) an inwardly tapered region (64) formed at a proximal end of said holder (36) and surrounding said outwardly flared region (64) of said tube section (33). 4. An ultrasonic imaging probe (12) as in claim 3, further comprising: an inductor coil (80) coaxially housed within said tube section (33) and having its distal end electrically connected to said transducer (34), and wherein, said cable means (28) includes at least two leads (70, 76), one said lead (70) being connected to said transducer (34) and the other of said leads (76) being connected to a proximal end of said inductor coil (80). 5. An ultrasonic imaging probe (12) as in claim 3 or 4, wherein said holder (36) is generally cylindrical and defines an open elongate trough region (38), said transducer (34) being rigidly housed within said holder (36) at a proximal end of said trough region. 6. An ultrasonic imaging probe (12) as in claim 5, further comprising reflector means (44) rigidly housed within said holder (36) at a distal end of said trough region (38) and coaxially positioned with respect to said transducer (34) for reflecting ultrasonic waves at substantially right angles to the elongate axis of said probe (12). 7. An ultrasonic imaging probe (12) as in claim 6, wherein said reflector means (44) includes a polished planar surface (46) oriented at an angle of substantially 45° relative to the elongate axis of said probe (12) . 8. An ultrasonic imaging probe (12) as in claim 3, further comprising guide wire means (50) connected to and coaxially extending in advance of said holder (34) for assisting in the guiding and manipulation of said probe (12) during use. 9. An ultrasonic imaging probe (12) as in claim 8, wherein said guide wire means (50) includes an axially flexible coiled guide wire. 10. An ultrasonic imaging probe (12) as in claim 9, wherein said guide wire means. (50) includes a tip (52) at the distal end thereof, and a continuous safety ribbon (54) positioned within said coiled guide wire and having one end rigidly fixed to said tip (52) and another end rigidly attached to the distal end of said holder (34). 11. An ultrasonic imaging probe (12) as in claim 10, wherein said reflector means (44) at said distal end thereof includes a distally projecting cylindrical boss (58) having an axially bevelled surface (56), said another end of said safety ribbon (54) being rigidly attached to said bevelled surface (54) of said boss (58). 12. An ultrasonic imaging probe (12) as in claim 8, further comprising second guide wire means (66) having a distal end connected to a proximal end of said holder (34) and proximally extending therefrom in surrounding relationship to said probe tube (33). 13. An ultrasonic imaging probe (12) as in claim 4, wherein said cable means (28) is a coaxial cable having (a) an inner electrically conductive lead (70) surrounded by an inner electrically insulative layer (72), and (b) an outer electrically conductive lead (74) surrounded by an outer electrically insulative layer (76), and wherein said outer electrically conductive lead (74) and insulative layer (76) annularly surround said inner electrically conductive lead (70) and insulative layer (72), and wherein said inner lead (70) is connected to said transducer (34) and said outer lead (74) is connected to said proximal end of said inductor coil (80) . 14. An ultrasonic imaging probe (12) as in claim 13, further comprising means associated with said coaxial cable for establishing an axial mounting space for said inductor coil (80) so that said inductor coil (80) and coaxial cable (28) are each positioned within said tube section, said mounting space establishing means being provided by an axially removed region of said outer electrically conductive lead (74) and insulative layer (76) to thereby expose a corresponding axial region of said inner electrically conductive lead (70) and insulative layer (72), wherein said inductor coil (80) occupies the space of said removed region of said outer electrically conductive lead (74) and insulative layer (76) such that said inductor coil (80) annularly surrounds said exposed corresponding axial region of said inner electrically conductive lead (70) and insulative layer (72). 15. An ultrasonic imaging probe (12) comprising: an elongate probe guide assembly (14) establishing a probe axis; a holder (36) defining an open trough (38); an ultrasound reflector (44) rigidly coupled to said holder (36) at a distal end of said trough (38) for reflecting incident ultrasonic waves between a first path which is parallel to said probe axis and a second path which is radial to said probe axis; and an ultrasound transducer (34) rigidly coupled to said holder (36) at a proximal end of said trough (38) for propagating ultrasonic waves towards, and receiving ultrasonic waves from, said reflector (44) along said first path; and wherein said reflector (44) is axially distally spaced from said transducer (34) by a predetermined dimension such that, for a given frequency of operation of said transducer, an area where ultrasonic imaging is not possible for said given frequency lies between said transducer (34) and reflector (44) and thus permits said probe to perform ultrasonic imaging immediately radially adjacent an external periphery of said holder (36). 16. An ultrasonic imaging probe as in claim 15 further comprising a solid ultrasonic couplant medium (49) filling said trough (38) in the space between said transducer (34) and reflector (44). 17. An ultrasonic imaging probe (12) as in claim 16, wherein said solid ultrasonic couplant medium (49) consists essentially of a polymeric material which is substantially non-absorbant to said ultrasonic waves. 18. An ultrasonic imaging probe (12) as in claim 16, wherein said holder (36) is generally cylindrical in configuration, and wherein said holder (36) and said solid couplant medium (49) collectively define a continuous smooth cylindrical outer surface.

Inventors: GESSERT JAMES M, GRIFFITH JAMES M, MACIEL MARIO, POPE JOSEPH L JR, ZALESKY PAUL J, GESSERT, JAMES, M., GRIFFITH, JAMES, M., MACIEL, MARIO, POPE, JOSEPH, L., JR., ZALESKY, PAUL, J.
Applicants: INTER THERAPY INC, INTER-THERAPY, INC.
Application year: 1989
Main classification: A61B8
IPC codes: A61B8, A61M25