WO2005058128A2

WO2005058128A2 - Medical endovaginal instrument for use with ultrasound probes

Info

Publication number: WO2005058128A2
Application number: PCT/IL2004/001139
Authority: WO
Inventors: Ron Tepper
Original assignee: Ron-Tech Medical Ltd.
Priority date: 2003-12-17
Filing date: 2004-12-16
Publication date: 2005-06-30
Also published as: WO2005058128A3

Abstract

A medical endovaginal instrument particularly useful as a speculum has a pair of arms pivotally mounted with respect to each other and formed with convex non-confronting surfaces to facilitate their insertion, into the vagina of a patient, and with concave confronting surfaces to facilitate collection of fluids within the patient's vagina when inserted therein. At least one of the arms is formed at or adjacent to its distal end, with a passageway extending through the interior of the arm and configured to receive an ultrasound transducer such as to expose it to tissue in the vagina when the arms are inserted therein.

Description

MEDICAL ENDOVAGINAL INSTRUMENT FOR USE WITH ULTRASOUND PROBES

FIELD AND BACKGROUND OF THE INVENTION The present invention relates to medical endovaginal instruments for use with ultrasound probes. The invention is particularly useful in a speculum type instrument incorporating, or capable of incorporating, an ultrasound probe for examining the interior of a patient's vagina and for collecting fluid therefrom, and the invention is therefore described below particularly with respect to this application. Endovaginal ultrasound transducers for diagnosing and monitoring obstetric and gynecological disorders are well known in the art, for example as described in U.S. Patents 4,497,325, 4,671,292, 4,681,103, 4,681,103, 4,742,829, 4,877,033, 4,883,059 and 5,280,427 incorporated herein by reference. For various reasons, the use of such transducers for real-time monitoring of intra-uterine, cervical and tubal procedures is very limited. These limitations are generally discussed in prior U.S. Patents, 5,833,611, 6,210,330 and 6,371,973, also incorporated herein by reference. The latter patents describe various types of forceps for holding a patient's cervix while utihzing ultrasound transducers for monitoring intra-uterine, cervical and tubal procedures in a real-time manner. The latter patents generally include an external connector or attaching device for attaching the ultrasound transducer to the forceps.

OBJECTS AND BRIEF SUMMARY OF THE PRESENT INVENTION An obj ect of the present invention is to provide a medical endovaginal instrument incorporating, or capable of incorporating, an ultrasound transducer in a very compact manner such as to facilitate the insertion of the instrument with the transducer into the vagina of a patient. Another object of the invention is to provide such an instrument of a construction enabling the instrument with the transducer also to be used as a speculum for accumulating and removing fluids from the patient's vagina. According to one broad aspect of the present invention, there is provided a medical endovaginal instrument comprising: first and second arms each having a proximal end and a distal end, the arms being configured for insertion via their distal ends into a patient's vagina and being movably mounted with respect to each other at their proximal ends to move their distal ends towards and away from each other; characterized in that at least one of the arms is integrally formed at or adjacent to the distal end of the arm, with a passageway extending through the interior of the arm and configured to receive an ultrasound transducer and to expose it to tissue in the patient's vagina when the arms are inserted therein. In the preferred embodiments of the invention described below, the first and second arms include non-confronting faces of a generally convex configuration to facilitate insertion of the two arms into the patient's vagina, and confronting faces of a generally concave configuration to facilitate collection of fluids within the patient's vagina when the arms are inserted therein. An instrument constructed with the foregoing features is capable of receiving an ultrasound transducer in a compact manner such as to greatly facilitate the use of an endovaginal ultrasound transducer for diagnosing and monitoring obstetric and gynecological disorders. The instrument may be constructed so as to accommodate existing endovaginal ultrasound transducers. The passageway may extend through the respective arm of the instrument, from its proximal end to its distal end. The ultrasound transducer may be received within the passageway at the proximal end of the arm and slidable through the passageway to the distal end of the arm. Alternatively, the ultrasound transducer may be fixed within the passageway at the distal end of the arm. According to further features in the described preferred embodiments, the instrument further comprises a handle constructed for manually grasping the instrument, the first arm being fixed with respect to the handle, and the second arm being pivotal with respect to the handle and the first arm. In one described preferred embodiment, the passageway is formed in the second arm, i.e., the pivotal arm; and in another described embodiment, the passageway is formed in the first arm, i.e., the arm fixed to the handle. In a third described embodiment, a passageway is formed in each of the two arms, each of the passageways being configured for receiving an ultrasound transducer to be exposed at the distal end of the respective arm to tissue in the patient's vagina when the arms are inserted therein. According to another aspect of the present invention, there is provided a medical endovaginal speculum comprising: first and second arms having proximal and distal ends and pivotally mounted with respect to each other at their proximal ends for insertion via their distal ends into the vagina of a patient; at least one of the arms being integrally formed, at or adjacent to the distal end of arm, with a passageway extending through the interior of the arm and configured to receive an ultrasound transducer and to expose it to tissue in the patient's vagina when the arms are inserted therein. Further features and advantages of the invention will be apparent from the description below.

BRIEF DESCRIPTION OF THE DRAWINGS The invention is herein described, by way of example only, with reference to the accompanying drawings, wherein: Fig. 1 illustrates one form of medical endovaginal instrument constructed in accordance with the present invention; Fig. 1 a is a section along line A — A of Fig. 1 ; Fig. 2 is a three-dimensional view of the instrument of Fig. 1 from the handle end of the instrument; Fig. 3 illustrates the instrument of Fig. 1 when one arm is pivoted to an open position with respect to the other arm; Fig. 4 illustrates the instrument of Fig. 1 when one arm is displaced to an open position with respect to the other arm; Fig. 5 illustrates another embodiment of the invention wherein the ultrasound transducer extends through the lower arm of the instrument; Fig. 5a is a section along line A — A of Fig. 5; Fig. 5b is a fragmentary view more particularly illustrating the section of Fig. 5a; Fig. 6 illustrates a still further embodiment of the invention wherein both arms of the instrument carry ultrasound transducers; and Fig. 7 is a fragmentary view illustrating a modification that may be applied to any of the foregoing constructions. It is to be understood that the foregoing drawings, and the description below, are provided primarily for purposes of facilitating understanding the conceptual aspects of the invention and various possible embodiments thereof, including what is presently considered to be a preferred embodiment. In the interest of clarity and brevity, no attempt is made to provide more details than necessary to enable one skilled in the art, using routine skill and design, to understand and practice the described invention. It is to be further understood that the embodiments described are for purposes of example only, and that the invention is capable of being embodied in other forms and applications than described herein.

DESCRIPTION OF PREFERRED EMBODIMENTS For purposes of example, the invention is described herein as embodied in a disposable speculum of the construction described in U.S. Patent 3,716,047, of February 13, 1973. It will be appreciated, however, that such an implementation of the present invention is set forth herein merely as a preferred embodiment of the invention, and that the invention may advantageously be implemented in many other constructions of medical endovaginal instruments. The medical endovaginal instrument illustrated in Figs. 1 - 4 is constructed of four principal parts: a first part, generally designated 10, which includes a first arm 11 and a handle 12 joined to arm 11 at its proximal end 11a (with respect to the user, e.g., a physician); a second part, generally designated 20, which includes a second arm 21 movably mounted with respect to the first arm 11; a third part, generally designated 30, in the form of a coupling member which couples the second arm 21 for both pivotal movement (shown in Fig. 3) and displaceable movement (shown in Fig. 4) with respect to the first arm 11 ; and a fourth part, constituting an μltrasound transducer 40, receivable within part 20. Preferably, parts 10, 20 and 30 are made of plastic for one-time use, but could also be made of metal for repeated use after proper cleaning and sterilization. The ultrasound transducer 40 is preferably removable from part 20 for repeated use. The construction of the first part 10 is more particularly seen in Figs. 1 and la. Thus, part 10 is integrally formed with handle 12 and the first arm 11 at its proximal end 11a and extends perpendicularly thereto. Handle 11 is constructed for manual grasping by the user and includes a channel 13 on the side thereof opposite to arm 11 for slidably receiving the coupling member 30. As shown particularly in Fig. la, arm 11 is formed with an outer or non-confronting face 14 of generally convex configuration to facilitate insertion of the two arms 12, 21 via their distal ends 1 lb, 12b into the patient's vagina, and with an inner or confronting face 15 of generally concave configuration to facilitate accumulation of fluids from the patient's vagina when the two arms are inserted therein. In addition, the lower end of handle 11 is formed with transversely-extending teeth 17 cooperable with a retainer element on the coupling member 30 for releasably retaining the coupling member in a selected displaced position with respect to the handle. The second part 20 includes, in addition to the second arm 21, a tongue 22 integrally formed with arm 21 at its proximal end 21a, and depending at an angle from that end of the arm. As shown in Fig. 2, tongue 22 is formed with an enlarged opening 23 aligned with the proximal ends 1 la, 21a of the two arms 11 and 21 to provide access to the interior of the two arms. Tongue 22 is integrally formed at its lower end with a finger- piece 24 engageable by the user's finger to pivot arm 21 with respect to arm 11, as will be described more particularly below. Tongue 22 is further formed at the lower end of its opening 23 with an edge 22a which cooperates with coupling member 30 to releasably retain arm 21 in its pivoted position, as will also be described more particularly below. Arm 21 is similarly formed, as arm 11, with an outer or non-confronting face 25 of a generally convex configuration to facilitate insertion of the two arms 21 and 11 into the patient's vagina, and with an inner or confronting face 26 of a concave configuration to facilitate collection of the fluids within the patient's vagina when inserted therein. Arm 11 is slightly longer than arm 21 such that the distal end 21b of arm 21 extends slightly outwardly of the distal end 1 lb of arm 11. As shown in Fig. la, arm 21 is thickened and is formed with a passageway 27 therethrough extending from its proximal end 21a to its distal end 21b. Ultrasound transducer 40 is received within passageway 27 such that its distal end 40a is exposed at the distal end 21b of arm 21 to contact tissue within the vagina when the two arms 12 and 21 are inserted therein. Passageway 27 would have a cross-section configuration corresponding to the outer configuration of the ultrasound transducer 40. In the described preferred embodiment, both are of circular cross-section. As indicated earlier, coupling member 30 serves to couple arm 21 for pivotal movement, and also for displaceable movement, with respect to arm 11. For this purpose, coupling member includes a first section 31 at one end slidably attaching the coupling member to handle 11. Coupling member 30 also includes a second section 32 at its opposite end pivotally coupled to proximal end 21a of arm 21. This pivotal coupling is effected by means of pins 33 integrally formed at the ends of section 32 and received within openings formed in proximal end 21 a of arm 21. Coupling member 30 is further formed with two elastic retainer elements 33 and 34 for releasably retaining arm 21 at a selected displaced position, and at a selected pivoted position, respectively, with respect to arm 11. Elastic retainer element 33 is integrally formed at the lower end of section 31 of coupling member 30 and cooperates with teeth 17 integrally formed in the lower end of handle 12 for releasably retaining the coupling member in a selected displaced position with respect to the handle. For this purpose, retainer element 33 includes a web 33a integrally formed at the lower end of section 31 , a first extension 33b substantially parallel to but spaced from section 31, and a second extension 33c projecting below web 33a at an angle to section 31. Extension 33c serves as a releasable retainer element normally urged towards the teeth 17 at the bottom of handle 12 to releasably retain coupling member 30 at a desired displaced position with respect to the handle. Extension 33b serves as a finger-piece pressable downwardly by the user's finger to release element 33c from engagement with teeth 17 in order to displace coupling member 30 to another position with respect to handle 12. Elastic retainer element 34 (Fig. 2) is a curved elastic strip integrally formed with section 31 of coupling member 30 and extending outwardly thereof, on the side opposite to the two arms 11 and 21. Retainer element 34 extends through opening 23 of tongue 22, and includes teeth 35 formed in its lower face so as normally to engage edge 22a of tongue 22, and thereby to retain arm 21 in a selected pivoted position with respect to arm 11. Arm 21 is pivoted to the selected position by pressing down on finger-piece 24 of tongue 22 and releasing the finger piece at the selected position, whereupon edge 22a of tongue 22 seats between two of the teeth 35 of retainer element 34 by the inherent elasticity of the retainer element. When it is desired to change the pivoted position of arm 21 with respect to arm 11 , the free end of retainer element 34 is manually pressed upwardly, to thereby unseat teeth 35 from edge 22a, permitting the tongue 21, and arm 11 integrally formed with the tongue, to be pivoted to another selected position. As indicated earlier, ultrasound transducer 40 is received within passageway 27 in the upper arm 21 such that the distal end 40b of the transducer is exposed for contact with tissue in the patient's vagina when the two arms 11, 21 are inserted therein via their distal ends 1 lb, 12b. The proximal end 40a of ultrasound transducer unit 40 is connected by electrical conductors 41 to the electrical circuit of that unit. Preferably, passageway 27 extends through arm 21 from its proximal end 21a to its distal end 21b, and the ultrasound transducer 40 is slidably received with the passageway at the proximal end of the arm and is slidable through the passageway to the distal end of the arm. The ultrasound transducer 40 may also be fixed within passageway 27, or may be fixed within the passageway only at the distal end 21b of the arm and connected by the electrical conductors 41 extending through the proximal end of the passageway to the electrical circuit for the transducer. The manner of using the described instrument will be apparent from the above description. Thus, the two arms 11, 21 of the instrument may be inserted into the patient's vagina with or without the ultrasound transducer 40. If inserted into the patient's vagina without the transducer 40, the two arms would first be moved to their closed positions as illustrated in Fig. 1, inserted into the patient's vagina via the distal ends 1 lb, 21b of the two arms, and then arm 21 would be moved to its pivoted position as illustrated in Fig. 3, or to its displaced position as illustrated in Fig. 4, and retained in such position by the elastic retainer elements 33 and 34 in the manner described above. The ultrasound transducer 40 may then be inserted into passageway 27 of the upper arm 21, via its proximal end 21a, and slid through the passageway until the distal end 40b of the ultrasound transducer comes into contact with tissue in the patient's vagina at the distal end 21b of arm 21. In this open position of the two arms 11, 21, the appropriate surgical instruments may be inserted into the interior of the vagina via the open proximal ends 1 la, 21a of the two arms according to the treatment to be performed, while the ultrasound transducer 40 is activated to monitor the treatment. If fluids from the vagina are to be removed, this may be done using standard implements applied through opening 23 of tongue 22 at the proximal side of the implement facing the physician. Such fluids may be collected within arm 11 and removed via a passageway in handle 12 communicating with the interior of the arm. Alternatively, the ultrasound transducer 40 may be received within passageway 27 of arm 21 before the two arms 21, 11 are introduced into the patient's vagina and manipulated to the desired position. The ultrasound unit may also be fixed within that passageway, to extend through the complete passageway or only at the distal end. In any case, the distal end 40a of the ultrasound transducer 40 would be in contact with tissue within the patient's vagina, such as to enable the transducer to accurately monitor the treatment. Fig. 5 illustrates an embodiment substantially the same as that described above with respect to Figs. 1 - 4, except that the lower arm, therein designated 111, is thickened and is formed with the passageway 127 to accommodate the ultrasound transducer 40; and the upper arm, therein designated 121, is of a conventional construction for a speculum of this type. Fig. 6 illustrates a further embodiment wherein the implement includes two ultrasound transducer units 241, 242, one disposed in each of the two arms 211 and 221, respectively. Thus, in this embodiment, both arms 211 and 221 would be thickened and formed with the passageways, shown at 227a and 227b, respectively, each for receiving one of the ultrasound transducers units 241, 242. In all other respects, the embodiments illustrated in Figs. 5 and 6 are of basically the same construction, and are used basically in the same manner, as described above with respect to Figs. 1 - 4. In all of the above-described embodiments, the operative face at the distal end of the ultrasound transducer (e.g., 40) may be substantially flush with the distal face of the respective arm in which it is inserted in order to contact the tissue within the patient's vagina, or it may project slightly outwardly of the distal end of the arm in order to make firm contact with such tissue. The operative face of the ultrasound transducer may be flat and perpendicular to the longitudinal axis of the transducer. However, in order to provide some directional control to the ultrasound emitted by the transducer, the operative face may be cut at a bias to the longitudinal axis of the transducer, and the transducer rotated within its passageway to change the direction of the ultrasound emitted therefrom. Fig. 7 is a fragmentary view illustrating a further modification that may be provided. Thus, as shown in Fig. 7, the passageway, therein designated 327, in the arm 321 receiving the ultrasound transducer is enlarged at its distal end, to extend partly into the non-confronting face 325 of the arm, to thereby provide an enlarged upwardly-facing opening 327a at the distal end of the arm exposing the distal end of the ultrasound transducer. In addition, the distal end of the ultrasound transducer may be flat, oriented perpendicularly to its axis, or cut at a bias, and aligned with opening 327a. Such a modification enables the distal end of the transducer to contact the tissue in the patient's vagina overlying mat opening when the two arms are introduced into the patient's vagina. In this modification, the ultrasound transducer 340 may also be rotatably, as well as slidably, movable within its passageway 327 to enable some control as to the tissue to be contacted by the distal end of the transducer, and the direction of the ultrasound to be emitted therefrom. While the invention has been described with respect to several prefereed embodiments, it is to be emphasized that these are set forth merely for purposes of example, and that, many other variations, modifications and applications of the invention may be made.

Claims

WHAT IS CLAIMED IS: 1. A medical endovaginal instrument comprising first and second arms each having a proximal end and a distal end, said arms being configured for insertion via their distal ends into a patient's vagina and being movably mounted with respect to each other at their proximal ends to move their distal ends towards and away from each other; characterized in that at least one of said arms is integrally formed, at or adjacent to the distal end of the arm, with a passageway extending through the interior of the arm and configured to receive an ultrasound transducer and to expose it to tissue in the patient's vagina when said arms are inserted therein.

2. The instrument according to Claim 1, wherein said first and second arms include non-confronting faces of a generally convex configuration to facilitate insertion of the two arms into the patient's vagina, and confronting faces of a generally concave configuration to facilitate collection of fluids within the patient's vagina when the arms are inserted therein.

3. The instrument according to Claim 1, wherein an ultra sound transducer is received within said passageway at said distal end of the arm.

4. The instrument according to Claim 3, wherein said passageway extends through the respective arm from its proximal end to its distal end, and wherein said ultra sound transducer is received within the passageway at the proximal end of the arm and is slidable through the passageway to the distal end of the arm.

5. The instrument according to Claim 3, wherein said ultra sound transducer is fixed within the passageway at the distal end of the arm.

6. The instrument according to Claim 1, wherein said instrument further comprises a handle constructed for manually grasping the instrument; said first arm being fixed with respect to said handle; said second arm being pivotal with respect to said handle and said first arm.

7. The instrument according to Claim 6, wherein said passageway is formed in said second arm.

8. The instrument according to Claim 6, wherein said passageway is formed in said first arm.

9. The instrument according to Claim 6, wherein said passageway is formed in each of said arms, each of said passageways being configured for receiving an ultrasound transducer to be exposed at the distal end of the respective arm to tissue in the patient's vagina when said arms are inserted therein.

10. The instrument according to Claim 6, wherein second arm is also displaceable towards and away from said first arm.

11. The instrument according to Claim 10, wherein said instrument further comprises a coupling member coupling said second arm to said handle; said coupling member including a first section at one end slidably coupling said coupling member to said handle, and a second section at the opposite end pivotally coupling thereto said second arm.

12. The instrument according to Claim 11, wherein said first section of the coupling member includes a manually-releasable retainer element coooperable with teeth formed in the handle for releasably retaining the coupling member in a selected displaced position with respect to said handle.

13. The instrument according to Claim 11, wherein said coupling member includes a manually-releasable retainer element cooperable with the second arm for releasable retaining the second arm in a selected pivoted position with respect to said first arm.

14. The instrument according to Claim 6, wherein said two arms include non- confronting faces of a generally convex configuration to facilitate insertion of the two arms into the patient's vagina, and wherein said passageway is enlarged at the distal end of the respective arm to extend partly into the non-confronting face of the respective arm at said distal end.

15. A medical endovaginal speculum comprising: first and second arms having proximal and distal ends and pivotally mounted with respect to each other at their proximal ends for insertion via their distal ends into the vagina of a patient; at least one of said arms being integrally formed, at or adjacent to the distal end of arm, with a passageway extending through the interior of the arm and configured to receive an ultrasound transducer and to expose it to tissue in the patient's vagina when said arms are inserted therein.

16. The speculum according to Claim 15, wherein an ultrasound transducer is received within said passageway at said distal end of the arm.

17. The speculum according to Claim 16, wherein said passageway extends through the respective arm from its proximal end to its distal end, and wherein said ultra sound transducer is received within the passageway at the proximal end of the arm and is slidable through the passageway to the distal end of the arm.

18. The speculum according to Claim 17, wherein said ultra sound transducer is fixed within the passageway at the distal end of the arm.

19. The speculum according to Claim 15, wherein said passageway is formed in one of said arms for receiving an ultrasound transducer therein.

20. The speculum according to Claim 15, wherein said passageway is formed in each of said arms for receiving an ultrasound transducer therein.