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WO1997012552A1 - Plaque support amelioree pour transducteur - Google Patents

Plaque support amelioree pour transducteur Download PDF

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Publication number
WO1997012552A1
WO1997012552A1 PCT/US1996/015761 US9615761W WO9712552A1 WO 1997012552 A1 WO1997012552 A1 WO 1997012552A1 US 9615761 W US9615761 W US 9615761W WO 9712552 A1 WO9712552 A1 WO 9712552A1
Authority
WO
WIPO (PCT)
Prior art keywords
patient
support plate
transducer
transducer assembly
abdomen
Prior art date
Application number
PCT/US1996/015761
Other languages
English (en)
Inventor
Edward H. Hon
Original Assignee
Hon Edward H
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 Hon Edward H filed Critical Hon Edward H
Priority to AU73839/96A priority Critical patent/AU7383996A/en
Publication of WO1997012552A1 publication Critical patent/WO1997012552A1/fr

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Classifications

    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4272—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue
    • A61B8/4281—Details of probe positioning or probe attachment to the patient involving the acoustic interface between the transducer and the tissue characterised by sound-transmitting media or devices for coupling the transducer to the tissue
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/08—Clinical applications
    • A61B8/0866—Clinical applications involving foetal diagnosis; pre-natal or peri-natal diagnosis of the baby
    • A—HUMAN NECESSITIES
    • A61—MEDICAL OR VETERINARY SCIENCE; HYGIENE
    • A61B—DIAGNOSIS; SURGERY; IDENTIFICATION
    • A61B8/00—Diagnosis using ultrasonic, sonic or infrasonic waves
    • A61B8/42—Details of probe positioning or probe attachment to the patient
    • A61B8/4209—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames
    • A61B8/4227—Details of probe positioning or probe attachment to the patient by using holders, e.g. positioning frames characterised by straps, belts, cuffs or braces

Definitions

  • the present invention is directed to a support plate for holding a sensor, such as a transducer, in selected relationship against the body of a patient.
  • the present invention relates to apparatus for monitoring uterine contractions during pregnancy and throughout labor and delivery and an apparatus for ultrasound monitoring of a mother and the fetus.
  • Information relating to the frequency, magnitude and pattern of uterine contractions is valuable to the physician, as a measure of the normal progression of labor. Additionally, it provides a guide for nurses and physicians in the use of medication or the need for other remedial actions.
  • the two types of apparatus most widely used at the present time for monitoring labor contractions are: (1) internal catheters inserted into the uterus to measure changes in the amniotic fluid pressure in the amniotic sac such as generally shown in the Pack Patent No. 4,543,965; and (2) external devices which consist of a pressure transducer held in place on the abdomen of the patient by a belt fitted around the waist of the patient such as generally shown in the U.S. Patent No. 3,520,294 issued to Fuzzell, and external devices in which the pressure transducer is bound by a strong adhesive on the abdomen of the patient, such as disclosed in U.S. Patent No. 5,070,888 issued to Hon et al. on December 10, 1991.
  • the most reliable device is the internal type. This means for measuring uterine contractions usually provides accurate data, but has a number of significant disadvantages which include:
  • the uterine cervix must be partially dilated and the amniotic sac ruptured.
  • bacterial and/or viral contaminants may be carried from the vagina and/or cervix into the uterine cavity and cause serious infection.
  • the catheter system may not be used where certain complications exist, e.g. uterine bleeding, here catheter insertion might cause additional bleeding; fever due to suspected uterine infection, in this case catheter insertion might exacerbate the situation.
  • the lower segment of the uterus may be perforated.
  • Catheter insertion is uncomfortable for the patient and inconvenient and time consuming for the medical and nursing staff.
  • a sterile area must be prepared around the vaginal orifice and then draped with sterile towels.
  • the catheter, catheter guide, fluid filled syringe and pressure measuring appar ⁇ atus then have to be assembled. The entire operation usually takes 7-10 minutes.
  • Uterine contractions are often not monitored in the delivery room because current catheter systems usually place the pressure transducer directly on the fetal monitor so that patient transfer from labor to delivery room requires the reconnection of the catheter system to another pressure transducer on another fetal monitor-- an awkward and time-consuming process. Addi ⁇ tionally, it is difficult to maintain catheter sterility during the transfer process.
  • One of the external types of apparatus presently used consists of a pressure transducer held in place against the patient's abdomen by an encircling belt without any other fixation means. The belt provides the counter-pressure which keeps the pressure transducer firmly against the maternal abdominal wall during contractions.
  • the pressure transducer would merely ride up and down with each uterine contraction and hence would not reflect the changes in abdominal wall tension associated with uterine contractions.
  • the external system using only an encircling belt to secure the transducer is simple and convenient to use and does not suffer from some of the major disadvantages of the internal system, it too has significant problems, which include: 1. Even under the best of conditions the overall quality of data obtained by external means secured only by a belt is not as precise as that obtained using an internal uterine catheter.
  • Uterine contraction data is easily compromised by fluctuations in belt tension which does not provide the necessary fixation forces to keep the transducer in a fixed relationship to the abdomen. If the labor is intense and the patient moves, belt tension changes continually. Hence for satisfactory operation, the patient must be kept relatively immobile. Once belt tension has been altered by patient movement, the belt tension must be readjusted, otherwise no uterine activity data will be recovered.
  • FIG. 6 Another prior art device disclosed in "Science 1947" at page 427 (shown diagrammatically in Fig. 6 thereof) consisted of a heavy brass ring (240 grams) held in place on the abdomen by double coated Scotch brand ad ⁇ hesive tape applied to the bottom side. A strain gauge is held in the center of each ring by a single lever system. This system was devised by Dr. Reynolds, but has never been widely used and is not in use at the present time.
  • the Reynolds device used doubled-sided adhesive tape to prevent lateral movement of the rings.
  • the weight of the rings provided counter-pressure to hold the strain gauge against the abdomen during episodic changes in abdominal wall tension which occurs with uterine contractions. Since the operation of the device depended on gravitational forces to hold the strain gauge in correct relationship to the abdominal wall, it was mandatory that the patient be on her back and be relatively immobile during the use of the device.
  • an ultrasound transducer e.g. obtaining the fetal heartbeat, as well as a number of other conditions that cannot be observed directly.
  • a coupling gel is applied to the ultrasound transducer face and the ultrasound transducer is then moved over the area of the patient where the best data is obtained.
  • the data is typically observed on a monitor, and/or is stored on hard storage media.
  • the transducer would need to be coupled in a fixed position with respect to the patient and the application of a counterforce to the transducer would be necessary to reflect changes in the abdominal wall tension associated with uterine contractions.
  • the means for holding an ultrasound transducer on a patient was accomplished by using an encircling abdominal belt, as is commonly used for holding a tocodynamometer in place during the measurement of contractions in order to provide the necessary counterforce on the transducer.
  • such belts when used with an ultrasound transducer are difficult to keep in place because the transducer is not fixed to the patient.
  • the ultrasound transducer To function properly, the ultrasound transducer must be held in a fixed position once the belt has been tightened and locked. Since the surface of the maternal abdomen is not uniform or flat, it is sometimes difficult to fix the orientation of the ultrasound transducer at the optimum angle to obtain the fetal heartbeat. Because the tension of the belt system holds the transducer face essentially parallel to the maternal abdomen wall, it is sometimes difficult to obtain the required data, and it becomes necessary to change this parallel orientation by angulating the transducer face. Further, the abdomen of the pregnant woman does not maintain a constant shape during the testing period. The movement of the fetus, as well as contractions, cause the shape of the abdomen to change.
  • the present invention is directed to an external device for supporting a transducer assembly for measuring the frequency, magnitude and pattern of uterine contractions during labor and for supporting an ultrasound transducer for monitoring a fetus and mother during pregnancy.
  • the device of the present invention comprises an improved transducer support plate which is maintained in fixed contact with the abdomen of the patient by fastening pads, including an adhesive hydrogel and a belt encircling the patient to provide the necessary counterforces to the transducer support plate that is simple to attach and remove from a patient.
  • the transducer support plate of the present invention is adapted to receive and hold a removable sensor against the abdomen of the patient.
  • a hydrogel layer is present on the lower surface of the fastening pads for attachment to the patient.
  • the hydrogel is a mild adhesive which is sufficiently strong to provide the necessary fixation forces to fix the transducer support plate on the patient, but does not form a strong bond with the skin of the patient.
  • the hydrogel is easily removed from the skin of the patient without the use of solvents.
  • the encircling belt when placed around the abdominal wall of the patient and tightened, provides the necessary counterforces to any movement in the abdominal wall caused by uterine contraction or movement of the patient.
  • the combination of the encircling belt and the use of the hydrogel results in a stable attachment of the ultrasound transducer support plate to the patient.
  • the fastening pads may be made of a flexible material such as foam and act as a shock absorber for the support plate against the abdominal wall and are removably attachable to the transducer support plate.
  • the transducer support plate comprises a support base that is concave for adapting to the shape of the abdomen.
  • a cylindrical hollow tube projects through the center of the support base to support a housing for a sensor, which is typically a pressure transducer, that is held firmly against the abdomen of the patient.
  • Other sensing devices can also be used, such as are known in the art.
  • the tube may be integrally formed with the base or removably attached to the base.
  • the signal output of the transducer is connected by wires to a conventional amplifying and recording means.
  • the pressure transducer is fixed in a housing which is removably affixed within the hollow tubular member of the support base so that the transducer and its housing can be separated from the support base and the support base discarded after use, thereby permitting a sterile support base to be brought into contact with the patient's skin with each use.
  • a flexible membrane is fitted across the opening of the hollow tube so that the active surface of the transducer does not actually come into contact with the abdomen thereby maintaining the transducer in a clean condition and at the same time preventing contamination of the sensor by any preparatory material used in maintaining the support base on the abdomen.
  • an isolation ring surrounds the active surface of the transducer thereby isolating and confining a portion of the abdominal wall tissue.
  • the transducer measures the pressure changes in this confined portion of tissue which, because of its relative isolation from the other parts of the maternal abdominal wall tissue, is less subject to patient movement.
  • the present invention is also directed to an improved support plate for holding an ultrasound transducer in fixed position with respect to the patient and provides the necessary counterforces to the ultrasound transducer that is simple to attach and remove from the patient.
  • the improved support plate of the present invention comprises a central ultrasound transducer holding member made of a relatively rigid material having a central opening conforming to the periphery of the ultrasound transducer.
  • the transducer support plate is coupled to the abdominal wall of a patient with fastening pads and a belt encircling the abdomen of the patient.
  • the fastening pads are removably attachable to the transducer support plate and have a hydrogel layer on the lower surface of the fastening pads for attachment to the patient.
  • the hydrogel is a mild adhesive which is sufficiently strong to provide the necessary fixation forces to fix the transducer support plate on the patient, but does not form a strong bond with the skin of the patient.
  • the hydrogel is easily removed from the skin of the patient without the use of solvents.
  • the encircling belt when placed around the abdominal wall of the patient and tightened, provides the necessary counterforces to any movement in the abdominal wall caused by uterine contraction or movement of the patient.
  • the combination of the encircling belt and the use of the hydrogel results in a stable attachment of the ultrasound transducer support plate to the patient.
  • the fastening pads may be made of a flexible material such as foam and act as a shock absorber for the support plate against the abdominal wall.
  • Figure 1 is a top perspective view of the transducer support plate of the present invention with a uterine activity monitoring transducer and fastening pads in place and with an encircling belt attached to the support plate.
  • Figure 2 is a bottom plan view of the transducer support plate of the present invention shown in Figure 1.
  • Figure 3 is a top plan view of the transducer support plate of the present invention.
  • Figure 4 is a side elevational view of an a uterine activity monitoring transducer.
  • Figures 5A and 5B are top plan views of the fastening pads of the present invention used to fix the transducer support plate to the abdomen of a patient.
  • Figure 5C is a bottom plan view of the fastening pad of Figure 5A showing the hydrogel adhesive layer.
  • Figure 6 is a side sectional view of the support plate taken along lines 6-6 of Figure 1.
  • Figure 6A is an enlarged sectional view along line 6A of Figure 6 illustrating the attachment of the fastening pad to the support plate of the present invention.
  • Figure 7 is a top perspective view of the transducer support plate of the present invention with an ultrasound transducer and fastening pads in place and with an encircling belt attached to the support plate.
  • Figure 8 is a bottom plan view of the transducer support plate of the present invention shown in Figure 7.
  • Figure 9 is a top plan view of the transducer support plate of the present invention.
  • Figure 10 is a side elevational view of an ultrasound transducer.
  • Figures IIA and 11B are top plan views of the fastening pads of the present invention used to fix the transducer support plate to the abdomen of a patient.
  • Figure 11C is a bottom plan view of the fastening pad of Figure IIA showing the hydrogel adhesive layer.
  • Figure 12 is a side sectional view of the support plate taken along lines 12-12 of Figure 7.
  • Figure 12A is an enlarged sectional view along line 12A of Figure 12 illustrating the attachment of the fastening pad to the support plate of the present invention.
  • a substantially rectangular transducer support plate 10 of a relatively rigid material such as polyvinyl chloride (PVC) is shown having a central support base 12, for holding a transducer 40 described below, is shown.
  • the support base 12 is concave and has a hollow tubular fitting 14 mounted perpendicular substantially at the center of the support base 12 and projects above the surface 18 of the transducer support plate 10.
  • the hollow tubular fitting 14 may be formed integrally with the support base 12 or may be removably fixed to the support base 12 by threads, force fitted or other coupling means.
  • the tubular fitting 14 has an internal diameter of approximately 1 inch.
  • the upper portion 34 of the hollow tubular fitting 14 extends approximately 1- 1/2 inches above the support base 12 and the lower portion 35 of the tubular fitting 14 may extend below the support base proximately 1/2 inch as shown in Figure 6.
  • the depth of the lower portion 35 is a function of the firmness of the abdomen of the patient. In most applications a depth of 1/2 inch is sufficient. However, in the case of extremely obese patients a depth of 3/4 inch or even 1 inch may be desirable.
  • the support base 12 is slightly thicker near its center, gradually tapering out to a thinner thickness at its edges and around the perimeter of the support base 12 making the support base 12 somewhat flexible so as to permit the support base 12 to more readily conform to the shape of the abdomen of a pregnant patient.
  • the thickness of the support base 12 at its center is approximately 1/8 inch and at its edges is approximately 1/10 inch.
  • the diameter of the support base 12 is approximately 4 inches.
  • a plurality of small openings 20 pass through the support base 12.
  • a flexible protective membrane 22 is fixed so as to surround the entire circumference of the lower end 35 of the hollow tubular fitting 14 by glue or heat sealing, thereby forming a sterile and waterproof seal around the opening in the lower end of the hollow tube fitting 14.
  • loop members 28a and 28b for securing to the ends of a belt 30 used for encircling the patient to hold the transducer support plate 10 in place against the patient's abdomen.
  • the loop members 28a and 28b are relatively rigid, are made of the same material as the transducer support plate 10 and 17 can be molded to the transducer support plate 10.
  • the belt 30 provides the counterforces which keep the transducer 40 positioned firmly against the maternal abdominal wall during the monitoring of the uterine contractions of a patient. Without the belt 30, the transducer would merely ride up and down with each uterine contraction and hence would not reflect the changes in abdominal wall tension associated with uterine contractions.
  • each of the pins 32a-f has a rounded head 33 to facilitate the insertion on the pins 32a-f into openings 34a-f of the fastening pads 36a and 36b as shown in Figure 6A.
  • the rounded head 33 may have a larger diameter than the remainder of the pins 32a-f and a larger diameter than the holes 34a-f in order to lock the fastening pads 36a and 36b to the transducer support plate 10 once they are inserted over the pins 40a-40f.
  • the pins 34a-f are made of the same material as the transducer support plate 10 and can be molded as part of the plate during manufacture. Referring to Figures 1, and 5A-5C,
  • the fastening pads 36a and 36b have a width that corresponds to the width of the transducer support plate 10 and a length that extends beyond the length of the transducer support plate 10. In the preferred embodiment, the fastening pads 36a and 36b extend approximately 2 inches from each end 27 and 29 of the plate 10.
  • Each of the fastening pads 36a and 36b has a slot 50a and 50b, respectively corresponding in position to the loop members 28a and 28b, through which the loop members 28a and 28b may pass as the fastening pads 36a and 36b are placed over the transducer support plate 10 and holes 34a-f for engaging the pins 32a-f.
  • the slots 50a and 50b and the holes 34a-f align with loop members 28a and 28b, and pins 36a and 32a-f and function to secure the fastening pads 36a and 36b to the transducer support plate 10.
  • the slots 50a and 50b of the fastening pads 36a and 36b each have rounded enlarged ends 37 and 38 for accommodating the diameter of the loop members 28a and 28b.
  • the fastening pads 36a and 36b have and internal edge 59a and 59b, respectively, configured to fit around the holding member 12.
  • each of the fastening pads 36a and 36b comprises of a first layer of a flexible material, such as foam 39, and has a second layer of a mild adhesive, such as a hydrogel 52, applied to the lower surface of the foam layer 39 of the fastening pads 36a and 36b.
  • the hydrogel 52 sticks the fastening pads 36a and 36b to the skin of the abdominal wall to fasten the transducer support plate 10 to the patient.
  • a medical grade hydrogel 52 is commercially available from the 3M Company, and comprises a mild adhesive that is strong enough to maintain the transducer support plate 10 in a fixed position, yet does not form a solid bond with the skin of the patient.
  • the hydrogel 52 provides the necessary fixation forces to support the transducer support plate 10 against the abdomen of the patient.
  • a protective removable paper covering may cover the hydrogel 52 until such time as it is desired to use the device.
  • the encircling belt 30 when placed around the abdominal wall of the patient and tightened provides the necessary counter forces to any movement in the abdominal wall caused by uterine contraction or movement of the patient.
  • the hydrogel 52 provides the necessary fixation forces to keep the support transducer support plate 10 in a fixed position with respect to the patient's abdominal wall.
  • the combination of the encircling belt 30 and the use of the hydrogel 52 results in a stable attachment of the transducer 40 to the patient.
  • the flexibility of the fastening pads 36a and 36b acts as a shock absorber for the transducer support plate 10.
  • a portion of the interior of the hollow tubular fitting 14 has a thread 31 and a slot 32 is located in the wall of the upper portion 34 of the tubular fitting 14.
  • the interior of hollow tubular fitting 14 has a decreased diameter portion 50 forming a shoulder 56 for receiving a transducer assembly 42 having an increased diameter portion 59.
  • the transducer assembly 42 includes a transducer 40 which is a conventional, commercially available transducer such as sold by Transamerica Delaval, Inc. which measures pressure applied to its active surface 44. Electrical lead wire 46 from the transducer 42 provides an electrical output signal response to the pressure applied to the active surface 44.
  • the detailed structure of the transducer assembly 42 is disclosed in U.S. Patent No. 5,070,888 issued to Hon et al. on December 10, 1990 and is incorporated herein by reference.
  • the pressure adjusting assembly is turned until the desired pressure on the transducer is achieved.
  • an isolation ring 43 Surrounding the active end 44 of the transducer 42 and projecting slightly below the active surface 44 is an isolation ring 43 which serves to accentuate and stabilize the transference of internal pressure, isolating the surface area from extraneous vibrations.
  • the transducer support plate 10 has a length of approximately 6 inches, and a width of approximately 4 inches.
  • the support base 12 is approximately 2 1/2 to 3 1/2 inches in diameter.
  • the size of the transducer support plate 10 is sufficiently large to accommodate the distortions in the abdomen of the patient and still provide a stable base for the ultrasound transducer 40. It is appreciated that the transducer support plate 10 may have any other size or configuration suitable for its intended purpose.
  • the abdomen of the patient is first cleansed by a sterile alcohol operation.
  • the backing sheet is then removed from the hydrogel layer 52 on the fastening pads 36a and 36b.
  • the support base 12 has its inner bottom surface pressed against the abdomen slightly deforming the support base 12 so that the support base 12 conforms substantially to the shape of the abdomen of the patient.
  • the transducer assembly 42 is then fitted within the hollow tubular fitting 14 so that the active face of the transducer 44 and the isolation ring 43 is in contact with the flexible membrane 22 which is pressed against the abdomen.
  • the lead wire 46 is then connected to the recording device 48 and the member 72 is then put in place and tuned. Accordingly the isolation ring 43 and the active element 44 are of the transducer pressed against the abdomen of the patient through the membrane 22.
  • the pattern of the contractions may now be observed on the recording apparatus.
  • the transducer assembly can be removed from the support base 12 at any time, leaving the support base 12 in place.
  • the patient can be moved from one location to another by disconnecting the lead wire 46 from the recorder or by removing the transducer assembly 42.
  • the transducer support plate 10 remains in place since the hydrogel 52 in combination with the belt 30 are sufficiently strong to form a fixed base relative to the skin of the patient.
  • the coupling formed between the abdomen and the support base is sufficiently strong to prevent the lifting of the support base 12 when subjected to the downward pressure of the transducer assembly 42.
  • the monitoring apparatus can be used, without adjusting the base line of the recording apparatus, whether the patient is lying down or standing up.
  • the transducer support plate 110 having a central ultrasound transducer holding member 112.
  • the transducer support plate 110 is substantially rectangular and is made of a relatively rigid material such as polyvinyl chloride (PVC) .
  • the holding member 112 has a circular opening 114 therein for receiving an ultrasound transducer 22 described below.
  • the transducer support plate 110 has a slightly concave shape so as to assist in conforming the transducer support plate 110 to the shape of the abdomen of the patient.
  • a sectional view of the transducer support plate 110 is shown.
  • the transducer support plate 110 has a ring 116 surrounding the opening 114 and rising slightly above the top surface 118 of transducer support plate 110.
  • the ring 116 is semi-flexible and functions to hold the ultrasound transducer 122 at a desired angle with respect to the abdomen of the patient.
  • a collar 124 that attaches to the periphery of the ring 116 may be employed for holding the ultrasound transducer 122 to maintain the ultrasound transducer 122 in position within the holding member 112.
  • the collar 124 threads onto the ring 116 which has threads 126 on the exterior surface of the ring 116 of the holding member 112.
  • the holding member 112 together with the transducer 122 forms a ball and socket arrangement as shown in Figure 112.
  • the ultrasound transducer 112 is friction fitted into the opening 114 of the holding member 112 and may be rotated in three degrees of freedom to the desired orientation.
  • the collar 124 is employed to hold the ultrasound transducer 122.
  • the shape of the inside wall of the central support member may be curved so as to conform to the outside surface of the ultrasound transducer 122 and still be able to be easily inserted into the opening 114.
  • any other means for holding the ultrasound transducer 122 such as the grasping members disclosed in U.S. Patent No. 4,920,966 issued to Hon et al. on May 1, 1990, incorporated herein by reference, may be employed.
  • the transducer support plate 110 may comprise a holding member 112 that maintains the ultrasound transducer 122 in a fixed position, without departing from the scope of the present invention.
  • the relatively rigid central holding member 112 is attached at its periphery to the relatively flexible transducer support plate 110 by conventional molding operation. It is appreciated that the entire transducer support plate 110 may be made of a relatively hard plastic, such as PVC, without departing from the scope of the present invention.
  • loop members 134 and 136 for attachment to the ends of a belt 138 used for encircling the patient to hold the transducer support plate 110 in place against the patient's abdomen.
  • the loop members 134 and 136 are relatively rigid, are made of the same material as the transducer support plate 110 and can be molded to the transducer support plate 110.
  • the belt 138 provides the necessary counter forces to keep the ultrasound transducer 122 firmly against the maternal abdominal wall during ultrasound monitoring of the patient.
  • each of the pins 140a-f has a rounded head 142 to facilitate the insertion on the pins 140a-f into openings 152a-f of the fastening pads 150a and 150b as shown in Figure 6A.
  • the rounded head 142 may have a larger diameter than the remainder of the pins 140a- f and a larger diameter than the holes 152a-f in order to lock the fastening pads 150a and 150b to the transducer support plate 110 once they are inserted over the pins 140a-f.
  • the pins 140a-f are made of the same material as the transducer support plate 110 and can be molded as part of the plate 110 during manufacture.
  • the fastening pads 150a and 150b have a width that corresponds to the width of the transducer support plate 110 and a length that extends beyond the length of the transducer support plate 110. In the preferred embodiment, the fastening pads 150a and 150b extend approximately 2 inches from each end 153 and 154 of the transducer support plate 110. Each of fastening pads 150a and 150b has a slot 158a and 158b, respectively, corresponding in position to the loop members 134 and 136, respectively, on the transducer support plate 110.
  • the loop members 134 and 136 may pass through the slots 158a and 158b, respectively, as the fastening pads 150a and 150b are placed over the transducer support plate 110 and holes 152a-f engage the pins 140a-f.
  • the slots 156a and 156b and the holes 152a-f align with loop members 134 and 136, and pins 140a- f, respectively, and function to secure the fastening pads 150a and 150b to the transducer support plate 110.
  • the slots 158a and 158b of the fastening pads 150a and 150b each have rounded enlarged ends 159 and 161 for accommodating the diameter of the loop members 134 and 136.
  • the fastening pads 150a and 150b have and internal edge 163a and 163b, respectively, configured to fit around the holding member 112.
  • each of the fastening pads 150a and 150b comprises of a first layer of a flexible material, such as foam 156 and has a second layer of a mild adhesive, such as a hydrogel 160, which is applied to the lower surface of the foam layer 156 of the fastening pads 150a and 150b.
  • the hydrogel 160 sticks the fastening pads 150a and 150b to the skin of the abdominal wall to fasten the transducer support plate 110 to the patient.
  • a medical grade hydrogel 160 is commercially available from the 3M Company, and comprises a mild adhesive that is strong enough to maintain the transducer support plate 110 in a fixed position, yet does not form a solid bond with the skin of the patient.
  • the hydrogel 160 provides the necessary fixation forces to support the transducer support plate 110 against the abdomen of the patient.
  • a protective removable paper covering may cover the hydrogel 160 until such time as it is desired to use the device.
  • the encircling belt 138 when placed around the abdominal wall of the patient and tightened provides the necessary counterforces to any movement in the abdominal wall caused by uterine contraction or movement of the patient.
  • the hydrogel 160 provides the necessary fixation forces to keep the transducer support plate 110 in a fixed position with respect to the patient's abdominal wall.
  • the combination of the encircling belt 138 and the use of the hydrogel 160 results in a stable attachment of the transducer 122 to the patient.
  • the flexibility of the fastening pads 150a and 150b acts as a shock absorber for the transducer support plate 110.
  • the transducer support plate 110 has a length of approximately 6 inches, and a width of approximately 4 inches.
  • the circular opening 114 in the holding member 112 is approximately 2 1/2 inches in diameter, only slightly larger than the diameter of a standard ultrasound transducer used in the United States such as sold by Corometrics, Inc. The precise size of the opening will depend on the diameter of the ultrasound transducer desired to be used with the device.
  • the size of the transducer 27 support plate 110 is sufficiently large to accommodate the distortions in the abdomen of the patient and still provide a stable base for the ultrasound transducer. It is appreciated that the transducer support plate 110 may have any other size or configuration suitable for its intended purpose.
  • the ultrasound transducer In using the ultrasound transducer, a singular sequence of preparatory steps usually used with an ultrasound transducer are used. The location of the fetus is determined by conventional means. The adhesive protective layer is removed from the fastening pads 150a and 150b of the transducer holder plate 110 and it is then applied to the location where it is desired to hold the ultrasound transducer 122. A small amount of ultrasonic coupling gel is then applied to the face of the ultrasound transducer 122 and the ultrasound transducer 122 is then placed in the opening 114 in the holder and reoriented until the strongest signal is observed on the monitor.
  • the collar 124 is then attached and turned to press against the outer periphery of the ultrasound transducer, thereby holding the ultrasound transducer 122 in a fixed orientation in relation to the patient.
  • the encircling belt 138 is then tensioned about the patient to provide the appropriate counterforces to the transducer support plate 110.
  • the transducer support plate 110 While the transducer support plate 110 is in place, it is possible for the patient to move, walk around and to even exercise enough so as to be subjected to an exercise stress test (a highly desirable test) .
  • the collar 124 is unscrewed so as to release the ultrasound transducer 122 for removal.
  • the transducer support plate 110 is then removed from the patient by unfastening the encircling belt 138 and lifting the transducer support plate 110 away from the patient's abdomen.
  • the hydrogel 160 is a mild adhesive, no solvents are necessary to remove the plate from the patient's skin.

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  • Ultra Sonic Daignosis Equipment (AREA)

Abstract

L'invention concerne un appareil externe destiné à recevoir et à maintenir un transducteur amovible (40) contre l'abdomen d'une patiente. L'appareil comprend une plaque support de transducteur (10) améliorée, maintenue en contact fixe avec l'abdomen de la patiente par des coussinets de fixation (36a, 36b) qui comportent un hydrogel adhésif, et par une ceinture (30) qui entoure la patiente de façon à fournir à la plaque support du transducteur les contre-forces nécessaires et qui est facile à attacher et à enlever.
PCT/US1996/015761 1995-10-02 1996-10-02 Plaque support amelioree pour transducteur WO1997012552A1 (fr)

Priority Applications (1)

Application Number Priority Date Filing Date Title
AU73839/96A AU7383996A (en) 1995-10-02 1996-10-02 An improved support plate for transducer

Applications Claiming Priority (4)

Application Number Priority Date Filing Date Title
US466195P 1995-10-02 1995-10-02
US469495P 1995-10-02 1995-10-02
US60/004,661 1995-10-02
US60/004,694 1995-10-02

Publications (1)

Publication Number Publication Date
WO1997012552A1 true WO1997012552A1 (fr) 1997-04-10

Family

ID=26673304

Family Applications (1)

Application Number Title Priority Date Filing Date
PCT/US1996/015761 WO1997012552A1 (fr) 1995-10-02 1996-10-02 Plaque support amelioree pour transducteur

Country Status (2)

Country Link
AU (1) AU7383996A (fr)
WO (1) WO1997012552A1 (fr)

Cited By (9)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2344893A (en) * 1998-12-14 2000-06-21 Geraldine Ahern Patient monitoring during child birth
WO2004091406A1 (fr) * 2003-04-09 2004-10-28 Dale Medical Products, Inc. Support de transducteurs
US7284730B2 (en) 2003-04-09 2007-10-23 Dale Medical Products, Inc. Transducer holder
US8074650B2 (en) 2004-02-27 2011-12-13 Dale Medical Products, Inc. Tracheostomy tube holder
CN103876777A (zh) * 2012-12-19 2014-06-25 通用电气公司 用于医疗装置的支承设备
CN104739443A (zh) * 2013-12-30 2015-07-01 深圳迈瑞生物医疗电子股份有限公司 一种医用体外超声探头及超声诊断仪
US20150182189A1 (en) * 2013-12-31 2015-07-02 General Electric Company Apparatus and method for aiding extremity ultrasonography
WO2017052363A1 (fr) * 2015-09-24 2017-03-30 Medacc Holding B.V. Dispositif de fixation d'un instrument médical
CN112261915A (zh) * 2018-06-07 2021-01-22 赞克特机器人有限公司 用于可安装在身体上的医疗器械的附接设备

Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4947853A (en) * 1985-09-26 1990-08-14 Hon Edward H Sensor support base and method of application
US5070880A (en) * 1990-10-30 1991-12-10 St. Louis University Transcranial Doppler transducer housing stabilizer
US5390675A (en) * 1993-10-06 1995-02-21 Medasonics, Inc. Transcranial doppler probe mounting assembly with external compression device/strap

Patent Citations (3)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
US4947853A (en) * 1985-09-26 1990-08-14 Hon Edward H Sensor support base and method of application
US5070880A (en) * 1990-10-30 1991-12-10 St. Louis University Transcranial Doppler transducer housing stabilizer
US5390675A (en) * 1993-10-06 1995-02-21 Medasonics, Inc. Transcranial doppler probe mounting assembly with external compression device/strap

Cited By (15)

* Cited by examiner, † Cited by third party
Publication number Priority date Publication date Assignee Title
GB2344893A (en) * 1998-12-14 2000-06-21 Geraldine Ahern Patient monitoring during child birth
WO2004091406A1 (fr) * 2003-04-09 2004-10-28 Dale Medical Products, Inc. Support de transducteurs
US7284730B2 (en) 2003-04-09 2007-10-23 Dale Medical Products, Inc. Transducer holder
US7284729B2 (en) 2003-04-09 2007-10-23 Dale Medical Products, Inc. Transducer holder
US8074650B2 (en) 2004-02-27 2011-12-13 Dale Medical Products, Inc. Tracheostomy tube holder
CN103876777A (zh) * 2012-12-19 2014-06-25 通用电气公司 用于医疗装置的支承设备
CN104739443A (zh) * 2013-12-30 2015-07-01 深圳迈瑞生物医疗电子股份有限公司 一种医用体外超声探头及超声诊断仪
WO2015100905A1 (fr) * 2013-12-30 2015-07-09 深圳迈瑞生物医疗电子股份有限公司 Sonde ultrasonore in-vitro médicale et appareil de diagnostic par ultrasons
CN104739443B (zh) * 2013-12-30 2018-06-26 深圳迈瑞生物医疗电子股份有限公司 一种医用体外超声探头及超声诊断仪
US10631824B2 (en) 2013-12-30 2020-04-28 Shenzhen Mindray Bio-Medical Electronics Co., Ltd. Medical body surface sticking ultrasonic probe
US20150182189A1 (en) * 2013-12-31 2015-07-02 General Electric Company Apparatus and method for aiding extremity ultrasonography
US9986970B2 (en) * 2013-12-31 2018-06-05 General Electric Company Apparatus and method for aiding extremity ultrasonography
WO2017052363A1 (fr) * 2015-09-24 2017-03-30 Medacc Holding B.V. Dispositif de fixation d'un instrument médical
CN112261915A (zh) * 2018-06-07 2021-01-22 赞克特机器人有限公司 用于可安装在身体上的医疗器械的附接设备
EP3801356A4 (fr) * 2018-06-07 2021-08-04 Xact Robotics Ltd. Appareil de fixation pour un dispositif médical pouvant être monté sur un corps

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