US20130197536A1

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Publication number: US20130197536A1
Application number: US13/720,086
Authority: US
Inventors: Jai Singh; Jiwan Steven Singh
Original assignee: Individual
Current assignee: Leapfrog Enterprises Pty Ltd Trustee For Leapfrog Trust AS
Priority date: 2011-04-07
Filing date: 2012-12-19
Publication date: 2013-08-01
Also published as: JP2015524714A; CN104768483B; US20150012009A1; CN104768483A; EP2861166A1; KR20150013710A; CN107518934A; HK1208792A1; AU2013317826B2; WO2014047554A1; JP6133423B2; AU2018241220B2; AU2017203026B2; KR101726666B1; EP2861166A4; CN107518934B; AU2018241220A1; US9101390B2; AU2013317826A1; AU2017203026A1

Abstract

A general uterine manipulator10 incorporates an elongated hollow tube12 defining an internal passage14. Tube12 has opposite first and second ends16 and18, formed with internal threads T1 and T2; and a smooth continuous outer surface20 of constant outer diameter. A first fitting comprising a tail screw22 is screwed into thread T1 and a second fitting cervical screw24 is screwed in thread T2. An inner manipulator rod26 extends through the first fitting22, tube12, and second fitting24. A range of alternate first and second fitting is provided. A forceps holder70 is attachable to the tube12 between ends16 and18. The manipulator10 may also support a cervical funnel90 and a plug92.

Description

CROSS-REFERENCE TO RELATED APPLICATION

This application claims the benefit of U.S. patent application Ser. No. 13/625,255 filed on Sep. 24, 2012, the contents of which application are herein incorporated by reference in their entirety.

FIELD OF THE INVENTION

The present invention relates to a general uterine manipulator and system which may be used in general surgery, gynaecological or non-surgical procedures.

BACKGROUND OF THE INVENTION

The present inventor has invented numerous medical instruments which are currently in use in surgical and non-surgical procedures. One such instrument is described in International publication no. WO 2008/074054 which is used in various procedures including total laparoscopic hysterectomy. The instrument described in this publication comprises a tube provided with an integral funnel at one end and through which a uterine cannula can be inserted. Both the tube and the cannula are provided with longitudinal slots or cut outs that aid in visualising the rotational position of a distal end of the instrument when inserted into the vagina and also aid in gripping of the instrument.

The success and efficacy of the above described and other instruments developed by the present inventor together with the need for improved and more versatile instruments have lead to the present invention.

SUMMARY OF THE INVENTION

According to one aspect of the present invention there is provided a general uterine manipulator comprising:

an elongated hollow tube defining an internal passage and having opposite first and second ends;

a smooth continuous outer surface of constant outer diameter extending between the first and second ends; and

internal first and second screw threads formed in the elongated hollow tube, the first screw thread being formed at the first end and the second screw thread being formed at the second end.

The general uterine manipulator may comprise a first fitting having a screw thread arranged to engage the first screw thread, the first fitting also having an axial through hole and configured to receive an inner manipulator shaft.

In some embodiments the first fitting is configured to apply increasing clamping force on a received inner manipulator when the first fitting a screw further into the first end.

The general uterine manipulator may comprise a hydrotubation port in fluid communication with the internal passage wherein a fluid injected into or through the hydrotubation port is able to flow into the internal passage.

In some embodiments the hydrotubation port is formed in the elongated hollow tube at a location near the first end and beyond the first screw thread.

In some embodiments the hydrotubation port is formed in the first fitting and is in fluid communication with the axial through hole.

The axial through hole may comprise a first length which opens onto an end of the first fitting distant the screw thread of the first fitting, and a second contiguous length wherein the first length has a first internal diameter and the second length has a second internal diameter which is greater than the first internal diameter; and wherein the hydrotubation port opens onto the second length of the axial through hole.

The general uterine manipulator may comprise a second fitting having a threaded portion provided with a screw thread configured to engage the second internal thread on the elongated hollow tube and a body portion extending co-linearly from the threaded portion.

In some embodiments the body portion comprises a tubular member which is open at one end distal the threaded portion and is closed at an end near to the threaded portion to form a cavity.

In some embodiments the tubular member comprises a circumferential wall and at least one internal passage formed in the circumferential wall, the or each internal passage opening onto axially opposite ends of the circumferential wall.

In some embodiments the body portion comprises a conically shaped portion with decreasing outer diameter in a taper direction being away from the threaded portion and wherein the conically shaped portion is provided with an external coarse screw thread.

In some embodiments the second fitting is provided with an axial through hole.

The general uterine manipulator may comprise an inner manipulator shaft, the shaft capable of being received in the axial through hole of the first fitting and the axial through hole of the second fitting and extending through the internal passage.

In some embodiments a crest of the coarse screw thread is provided with a flattened surface wherein a line on the flattened surface is inclined relative to a central axis of the coarse screw thread in the taper direction.

In some embodiments the coarse screw thread is a ball screw thread.

In some embodiments the general uterine manipulator comprising a forceps holder supported on the elongated hollow tube and configured to be releasably lockable in a plurality of positions along the elongated hollow tube.

In some embodiments the forceps holder comprises a first component seated on the elongated hollow tube and provided with a detent for gripping a finger hole of the forceps.

In some embodiments the forceps holder comprises a locking nut engagable with the first component and arranged to releasably lock the first component in a fixed position along the elongated hollow tube when rotated in a first direction, and to release the second component to allow sliding motion along the elongated hollow tube when rotated in an opposite direction.

In a second aspect there is provided general uterine manipulator comprising:

a smooth continuous outer surface of constant outer diameter extending between the first and second ends;

internal first and second screw threads formed in the elongated hollow tube, the first screw thread being formed at the first end and the second screw thread being formed at the second end;

a first fitting having a screw thread arranged to engage the first screw thread, the first fitting also having an axial through hole;

a second fitting having a threaded portion provided with a screw thread configured to engage the second internal thread on the elongated hollow tube and a body portion extending co-linearly from the threaded portion; and,

an inner manipulator shaft arranged to extend through the axial through hole, the internal passage and the second fitting, the inner manipulator shaft having one end which is bent and protrudes from the second fitting.

In one embodiment the general uterine manipulator comprises a resistance mechanism enabling the axial and rotational position of the inner manipulator shaft to substantially held in the absence of adjustment by a user of the manipulator.

In one embodiment the resistance mechanism comprises clamp shells incorporated in the first fitting.

In one embodiment the resistance mechanism comprises a bend in a portion of the inner manipulator shaft within the internal passage the bend being to an extent that the inner manipulator shaft bears against an inside surface of the tube.

In one embodiment the general uterine manipulator comprises a hydrotubation port formed in the first fitting and in fluid communication with the axial through hole wherein a fluid injected into or through the hydrotubation port is able to flow into the internal passage. In this embodiment the axial through hole comprises a first length which opens onto an end of the first fitting distant the screw thread of the first fitting, and a second contiguous length wherein the first length has a first internal diameter and the second length has a second internal diameter which is greater than the first internal diameter; and the hydrotubation port opens onto the second length of the axial through hole.

In one embodiment the second fitting comprises a threaded portion provided with a screw thread configured to engage the second internal thread on the elongated hollow tube and a body portion extending co-linearly from the threaded portion, the body portion having a frusto-conical shape with decreasing outer diameter in a direction away from the threaded portion and on which is provided an external coarse screw thread.

In one embodiment the general uterine manipulator comprises a forceps holder supported on the elongated hollow tube and configured to be releasably lockable in a plurality of positions along the elongated hollow tube.

In one embodiment the forceps holder comprises a first component seated on the elongated hollow tube and provided with a detent for gripping a handle of the forceps.

In one embodiment the forceps holder comprises a locking nut engagable with the first component and arranged to releasably lock the first component in a fixed position along the elongated hollow tube when rotated in a first direction, and to release the second component to allow sliding motion along the elongated hollow tube when rotated in an opposite direction.

In one embodiment the general uterine manipulator comprises a cervical funnel mounted on the tube.

In a third aspect there is provided a general uterine manipulator system comprising:

at least one first fitting the or each first fitting having a screw thread arranged to engage the first screw thread, the first fitting also having an axial through hole;

at least one second fitting the or each second fitting having a threaded portion provided with a screw thread configured to engage the second internal thread on the elongated hollow tube and a body portion extending co-linearly from the threaded portion;

wherein the at least one first fitting comprises one or both of: (a) a clamping first fitting configured to apply increasing clamping force on a received inner manipulator when the first fitting a screw further into the first end; and (b) a hydrotubation first fitting which has a hydrotubation port in fluid communication with the internal passage wherein a fluid injected into or through the hydrotubation port is able to flow into the internal passage; and wherein

- the at least one second fitting comprises one or both of: (c) a cervical second fitting in which its body portion is of a frusto-conical shape with decreasing outer diameter in a direction away from the threaded portion and is provided with an external coarse screw thread; and (d) a tubular second fitting in which its body portion comprises a tubular member which is open at one end distal the threaded portion of the second fitting and is closed at an end near to the threaded portion of the second fitting to form a cavity.

In one embodiment the tubular member of the tubular second fitting comprises a circumferential wall and at least one internal passage formed in the circumferential wall, the or each internal passage opening onto axially opposite ends of the circumferential wall.

In one embodiment the general uterine manipulator system comprises an inner manipulator shaft arranged to extend through the axial through hole, the internal passage and the second fitting when the second fitting is the cervical second fitting, the inner manipulator shaft having one end which is bent and protrudes from the cervical.

In one embodiment the general uterine manipulator system a resistance mechanism enabling the axial and rotational position of the inner manipulator shaft to substantially held in the absence of adjustment by a user.

In one embodiment the general uterine manipulator system a forceps holder supported on the elongated hollow tube and configured to be releasably lockable in a plurality of positions along the elongated hollow tube.

In a fourth aspect there is provided a medical instrument configured to facilitate a gynaecological procedure comprising:

a body provided with opposite first and second end portions, the first end portion having a first opening and the second end portion having a second opening;

a throughway extending between the first and second openings, the throughway arranged to enable the body to be supported on a shaft to facilitate insertion of one of the first and second end portions into a body cavity.

In one embodiment the first and second end portions are different in one or more of their shape, size and configuration.

In one embodiment the first end portion is of a tubular configuration and has a first outer diameter.

In one embodiment the second end portion is of a tubular configuration and has a second outer diameter that is different to the first outer diameter.

In one embodiment the second end portion is of a frusto conical configuration.

In one embodiment the first end portion is of a frusto conical configuration and has a first outer diameter.

In one embodiment the second end portion is of a frusta conical configuration and has a second outer diameter that is different to the first outer diameter.

In one embodiment the or each end portion of frusto conical configuration is provided with a lip that extends radially outward from an outer surface of the second end portion and for an arc of less than 360°.

In one embodiment one or both of the first and second end portions is provided with an illumination device arranged to enable the emission of light from the respective end portion.

In one embodiment the device comprises an illumination device arranged to enable the emission of light from the lip.

In one embodiment the general uterine manipulator system comprises an illumination device arranged to enable the emission of light from an end of the tubular portion.

In one embodiment the general uterine manipulator system comprises an illumination device arranged to enable the emission of light from an end of the cervical funnel.

In one embodiment the general uterine manipulator system comprises an illumination device arranged to enable the emission of light from an end of the tubular second fitting.

In one embodiment the general uterine manipulator system comprises a motor arranged to engage and rotate the cervical funnel.

In one embodiment the general uterine manipulator system comprises a foot operated switch associated with the motor and switchable between a first position wherein the motor rotates in a clockwise direction and a second position wherein the motor rotates in an anti-clockwise direction.

In one embodiment the cervical funnel has conical portion and a through hole formed in or near a large diameter end the conical portion.

In one embodiment the large diameter end of the conical portion has an outwardly flared lip that extend for a part of the circumference of the conical portion and wherein the hole is formed in the lip.

In one embodiment the general uterine manipulator system comprises an illumination device arranged to illuminate the through hole.

In a fifth aspect there is provided a cervical funnel comprising a conical portion and a through hole formed in or near a large diameter end the conical portion.

In one embodiment the funnel comprises the large diameter end of the conical portion has an outwardly flared lip that extend for a part of the circumference of the conical portion and wherein the hole is formed in the lip.

In one embodiment the funnel comprises an illumination device arranged to illuminate the through hole.

In one embodiment the illumination device comprises an annular light guide surrounding the through hole.

In a sixth aspect there is provided a cervical funnel comprising a conical portion and a tube extending coaxially form a small diameter end of the conical portion, wherein an outer surface of the tube is profiled to mechanically engage a motor to facilitate rotation of the cervical funnel.

In one embodiment the outer surface of the tube is provided with gear teeth arranged to enable mechanical engagement with the motor.

In one embodiment the funnel comprises a through hole formed in or near a large diameter end the conical portion.

In a seventh aspect there is provided a double ended medical instrument arranged for insertion into a body cavity comprising:

a body having a first probe at first end, a second probe at a second opposite end;

the first probe having a cylindrical portion with an first outer circumferential surface of a first diameter, a first circumferential edge distant the first end and a first lip projecting outwardly from the first outer circumferential surface beyond the first circumferential edge and extending for at least a part of a circumference of the first circumferential edge;

the second probe having a cylindrical portion with a second outer circumferential surface of a second outer diameter, a second circumferential edge distant the first probe and a second lip projecting outwardly from the second outer circumferential surface beyond the second circumferential edge and extending for at least a part of a circumference of the second circumferential edge;

wherein the first outer diameter and the second outer diameter are different from each other.

In one embodiment the first and second lips have respective mid-points that are located in axial alignment.

In one embodiment the part of the circumference of the first and second circumferential edges about which the first and second lips respectively extend are the same.

In one embodiment the first probe is provided with a first cavity extending axially from the first circumferential edge toward the second probe and having a first inner diameter.

In one embodiment the second probe is formed with a second cavity extending axially from the second circumferential edge toward the first probe and having a second inner diameter wherein the second inner diameter is different to the first inner diameter.

In one embodiment the first probe is provided with a first platform of constant first outer diameter extending over the first cylindrical portion from a circumferential edge of the first lip toward the second probe.

In one embodiment the first platform is co-extensive in a circumferential aspect with the first lip.

In one embodiment a side of the first platform rearward of the first lip slopes from the first outer diameter to first outer circumferential surface in a direction toward the second probe.

In one embodiment circumferentially opposite sides the first platform transition smoothly from first outer diameter the first outer circumferential surface.

In one embodiment the second probe is provided with a second platform of constant second outer diameter extending over the second cylindrical portion from a circumferential edge of the second lip toward the first probe.

In one embodiment the second platform is co-extensive in a circumferential aspect with the second lip.

In one embodiment a side of the second platform rearward of the second lip slopes from the second outer diameter in a direction toward the first probe.

In one embodiment circumferentially opposite sides the second platform transition smoothly from second outer diameter the second outer circumferential surface.

In one embodiment the platform has a circumferential surface of constant diameter extending coaxially with the first outer circumferential surface.

In one embodiment the double ended medical instrument comprises an intermediate portion that transitions smoothly between the first and second probes.

In one embodiment the intermediate portion has a central region of an outer diameter less than each of the first diameter and the second outer diameter.

In one embodiment the double ended medical instrument comprises an intermediate portion that transitions smoothly between the first and second probes wherein the intermediate portion is formed with an internal bore the bore extending in an axial direction between the first and second cavities and having an inner diameter smaller than each of the first and second inner diameters.

In one embodiment the first lip and second lip extend for the full circumference of first circumferential edge and the second circumferential edge respectively; the first probe being provided with a first platform of constant first outer diameter extending wholly about the first cylindrical portion from a circumferential edge of the first lip toward the second probe; and the second probe being provided with a second platform of constant second outer diameter extending wholly about the second cylindrical portion from a circumferential edge of the second lip toward the first probe.

BRIEF DESCRIPTION OF THE DRAWINGS

FIG. 1ais a representation of one embodiment of a general uterine manipulator in accordance with the present invention;

FIG. 1bis a disassembled view of the general uterine manipulator depicted inFIG. 1a;

FIG. 2 is a longitudinal section view of the tube incorporated in the general uterine manipulator shown inFIGS. 1aand1b;

FIG. 3 is an isometric view of a tail screw incorporated in the general uterine manipulator shown inFIGS. 1aand1b;

FIG. 4 is a side view of the tail screw shown inFIG. 3;

FIG. 5 is an end view of the tail screw shown inFIG. 3;

FIG. 6 is an isometric view of a second form of tail screw that may be incorporated in the general uterine manipulator shown inFIGS. 1aand1b;

FIG. 7 is a side view of the tail screw shown inFIG. 6;

FIG. 8 is an end view of the tail screw shown inFIG. 6;

FIG. 9ais a side view of a second fitting incorporated in the general uterine manipulator shown inFIGS. 1aand1b;

FIG. 9bis a longitudinal section view of the second fitting shown inFIG. 9a;

FIG. 9cis an isometric representation of the second fitting;

FIG. 10ais a side view of a second form of setting fitting that may be incorporated in the general uterine manipulator depicted inFIGS. 1aand1b;

FIG. 10bis an end view of the second fitting shown inFIG. 9a;

FIG. 10cis an isometric view from one end of the second fitting;

FIG. 10dis a isometric view from an opposite angle of the second fitting;

FIG. 11 is an isometric view of a forceps holder incorporated in the uterine manipulator;

FIG. 12 is an isometric view of an embodiment of the general uterine manipulator and associated system with additional fittings to enable performance of a total laparoscopic hysterectomy; and,

FIG. 13ais a side view of a cervical funnel incorporated in an embodiment of the general uterine manipulator shown inFIGS. 1aand1b;

FIG. 13bis a longitudinal section view of the cervical funnel;

FIG. 13cis an end view of the cervical funnel shown inFIGS. 13aand13b;

FIG. 14ais an isometric representation of a vaginal plug incorporated in an embodiment of the general uterine manipulator shown inFIGS. 1aand1b;

FIG. 14bis a section view of the vaginal plug shown inFIG. 14a;

FIG. 15 is a side view of a manipulator handle which may be incorporated in an embodiment of the general uterine manipulator;

FIG. 16ais a side view of a further from of second fitting that may be incorporated in the general uterine manipulator depicted inFIGS. 1aand1b;

FIG. 16bis an end view of the second fitting shown inFIG. 16a;

FIG. 16cis an isometric view from a first angle of the second fitting shown inFIG. 16a;

FIG. 16dis a isometric view from a second angle of the second fitting shown inFIG. 16a;

FIG. 16eis a schematic representation of an illumination device incorporated in the second fitting shown inFIG. 16a;

FIG. 17ais a side view of a cervical funnel with an illumination device incorporated in a further embodiment of the general uterine manipulator;

FIG. 17bis a longitudinal section view of the cervical funnel shown inFIG. 17a;

FIG. 17cis an end view of the cervical funnel shown in FIGS.17aand17b;

FIG. 17dis a schematic representation of the illumination device incorporated in the cervical funnel shown inFIGS. 17aand17b;

FIG. 18 is an isometric view of the general uterine manipulator shown inFIG. 12 but modified with the inclusion of a drive to enable powered rotation of an associated cervical funnel;

FIG. 19 is view of cross section A-A of the manipulator shown inFIG. 18;

FIG. 20 is a schematic representation of a medical instrument that can be incorporated in or used with an embodiment of the general uterine manipulator;

FIG. 21 is a schematic representation of an alternate medical instrument that can be incorporated in or used with an embodiment of the general uterine manipulator;

FIG. 22 is a schematic representation of a further form of medical instrument that can be incorporated in or used with an embodiment of the general uterine manipulator;

FIG. 23ais an isometric view of a double ended medical instrument that can be incorporated in or used with an embodiment of a general uterine manipulator;

FIG. 23bis a longitudinal section view of the instrument shown inFIG. 23a;

FIG. 23cis an end view of the instrument shown inFIG. 23a;

FIG. 24ais an isometric view of a further double ended medical instrument that can be incorporated in or used with an embodiment of a general uterine manipulator;

FIG. 24bis a longitudinal section view of the instrument shown inFIG. 24a;

FIG. 24cis an end view of the instrument shown inFIG. 24a;

FIG. 24dis an enlarged view of an extended probe that can be incorporated in the instrument shown inFIG. 24a;

FIG. 24edepicts a cross section of a platform of the probe shown inFIG. 24awith markings in the form of ridges;

FIG. 24fdepicts a cross section of a platform of the probe shown inFIG. 24awith markings in the form of grooves;

FIG. 24gdepicts a cross section of a platform of the probe shown inFIG. 24awith markings in the form of sets of adjacent grooves and ridges;

FIG. 25 illustrates a plug that can be used with the instruments depicted inFIGS. 20-24g;

FIG. 26 illustrates one end of a modified form of the double ended medical instrument shown inFIG. 24ahaving a full circumference platform;

FIG. 27ais a side view of a further embodiment cervical funnel with an illumination device that may be used with the general uterine manipulator;

FIG. 27bis a longitudinal section view of the cervical funnel shown inFIG. 27a;

FIG. 27cis an end view of the cervical funnel shown inFIGS. 27aand27b; and

FIG. 27dis a schematic representation of a lip portion of the cervical funnel shown inFIGS. 27aand27b.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENT

Embodiments of the general uterine manipulator and associated system provide a multipurpose manipulator that may be used for a variety of procedures by interchanging particular fittings of the manipulator. With particular reference toFIGS. 1ato2, each embodiment of the general uterine manipulator10 (hereinafter referred to in general as “manipulator10”) is based on or incorporates an elongatedhollow tube12 defining aninternal passage14.Tube12 has opposite first and second ends16 and18 and a smooth continuousouter surface20 of constant outer diameter. A first internal screw thread11 is formed at thefirst end16 and a secondinternal screw thread12 is formed at thesecond end18.

The versatility of themanipulator10 and associated system arises from the ability to connect with a number of different fittings depending on the specific application at hand.FIGS. 1aand1billustrate a first fitting in the form oftail screw22 and a second fitting in the form of acervical screw24. Aninner manipulator rod26 is also illustrated inFIGS. 1aand1bwhich extends through thefirst fitting22,tube12, andsecond fitting24.

One form of thefirst fitting22 is shown in greater detail inFIGS. 3 to 5. In this embodiment thefirst fitting22 comprises a threadedportion28; anintegral body portion30; and, an internalaxial hole32. Threadedportion28 is configured to engage screw thread T1 and is provided with atransverse slot34 terminating prior to thebody portion30.Slot34 in effect divides the threadedportion28 into opposed

clamp shells

36aand36b(hereinafter referred to in general as “clamp shells36”).Body portion30 is in the general form of a cylinder with two

flats

38aand38bon opposed sides that assist in gripping of the fitting22.Axial hole32 is of constant diameter for the length of the fitting22 except for acounter sink40 at a distal end of fitting22.

Threadedportion28 is slightly flared outwardly so as it is screwed into screw thread T1 atend16, the clamp shells36 move toward each other. When aninner manipulator rod26 is used in themanipulator10 this results in a clamping action on the rod providing resistance to movement of therod26 so as to hold it at a desired rotational and translational position. Unscrewing of theportion28 releases or reduces this resistance to enable adjustment of the position and orientation of therod26. Thus the first fitting can be considered in this embodiment as incorporating or comprising a resistance mechanism which substantially maintains the position of therod26 until moved or adjusted by a surgeon or other user.

FIGS. 6 to 8 depict an alternate form of the first fitting denoted as22′. Features of the fitting22′ which are of the same or similar configuration or function as those of fitting22 are denoted with the same reference numbers but with the addition of the prime (′) symbol. Fitting22′ comprises a threadedportion28′,body30′, an inneraxial hole32′ with counter sink40′ at a distal end, and opposed flats38′aand38′bformed onbody portion30′. Fitting22′ differs from fitting22 by the omission ofslot34, the inclusion of ahydrotubation port42, and a re-configuring of theaxial hole32′. With particular reference toFIG. 7 it can be seen that theaxial hole32′ has afirst length44 and a contiguoussecond length46. Thefirst length44 extends from the threadedportion28′ for a majority of the axial length of fitting22. Thesecond length46 extends between and joins thecounter sink40′ to thefirst length44. The inner diameter of thefirst length44 is greater than the inner diameter ofsecond length46′. Further, the inner diameter ofsecond length46 is dimensioned to be slightly greater than an outer diameter of theinner manipulator rod26 forming a close fit but enabling therod26 to pass through theaxial hole32′.

Hydrotubation port

42 is formed in thebody30′ at a location where it communicates with thefirst length44. The thread on threadedportion28′ is arranged to engage with the thread T1 atend16. In the event that for example themanipulator10 is being used in a gynaecological application and it is desired to inject a liquid such as a dye to assist in the visualisation of tissue the dye may be injected through thehydrotubation port42. The dye then flows through theinternal passage14 and from an opposite end ofsecond fitting24 attached to end18. In this regard in the event thatmanipulator rod26 is in use, a clearance exists between second fitting24 and an outer surface ofrod26 to allow the flow of dye or other fluid. Further, the close fitting between therod26 andsecond length46 ofaxial hole32′ substantially prevents any back leakage of the dye. Alternately and/or in addition if desired, a rubber grommet seal (not shown) may be provided in thesecond length46 to further minimize back leakage of dye or other liquid injected through thehydrotubation port42.

As the fitting22′ does not have the clamping shells36 of fitting22 it is unable to clampinner manipulation rod26. However in embodiments of themanipulator10, theinner manipulator rod26 can be bent to varying degrees intermediate of its length so that therod26 bears against an inside surface oftube12 to provide resistance to both axial and rotational motion when fitting22′ is used. This still allows therod26 to substantially maintain its position until moved or adjusted manipulated by a surgeon or other user. Thus the intermediate bend in therod26 can be equated with or considered to be another or alternate form of resistance mechanism which substantially maintains the position of therod26 until moved or adjusted by a surgeon or other user.

Thesecond fitting24 ofFIGS. 1aand1bis shown in greater detail inFIGS. 9a,9band9c. The fitting24 comprises a threadedportion48 configured to engage thread T2, and anintegral body portion50.Body portion50 is of a frusto-conical shape with a decreasing outer diameter in a taper direction D being away from threadedportion48. Acoarse screw thread52 is formed about the conically shapedbody portion50. The crest ofthread52 has a flattened surface orientated so that aline53 on the surface of the crest is inclined parallel with acentral axis55 ofsecond portion24. An axial throughhole57 is also formed throughsecond portion24. This allows for the passage of theinner manipulator rod26 and/or other instruments as well as fluids including saline, dye, and air. In this embodiment of themanipulator10,second fitting24 is a cervical screw which is configured to screw into the cervix forming an attachment point as well as a seal.

However, alternate forms of second fittings may be incorporated in themanipulator10.FIGS. 10a-10dillustrate an alternate second fitting24a. Fitting24ais in the form of a hollow probe having a threadedportion48aand abody portion50a. Threadedportion48ahas a thread configured to engage with thread T2.Body portion50ais in the form of a tubular member which is open at itsdistal end56 and is closed at anend58 near threadedportion48ato define or otherwise form acavity60.Distal end56 is formed with a chamfer or bevel62 to assist in insertion of the fitting24ainto a body cavity such as a vagina or rectum. Fitting24amay be used for example during a hysterectomy to maintain pneumoperitoneum after removal of the uterus. Thecavity60 also allows for collection of pelvic tissue and specimens from the abdominal and pelvic cavities. A lumen (i.e. through hole)64 may be formed axially through acircumferential wall66 of thebody50a. In one embodiment thelumen64 may have an internal diameter of approximately 6 mm to enable the receipt of a 4 mm telescope to enable illumination and visualization of tissue in cavities. For example this may be used in pelvic floor operations where the vagina and rectum septum need to be dissected out. This reduces the possibility of a recto-vaginal fistula occurring.

It is envisaged that the fitting24amay be made in a variety of different sizes and in particular different diameters. For example 40 mm outer diameter, 30 mm outer diameter, and 20 mm outer diameter.

FIG. 11 illustrates one form of aforceps holder70 that may be incorporated in an embodiment ofmanipulator10. Theforceps holder70 is configured to seat on the elongatedhollow tube12 and releasably lock at a desired location along thetube12.Forceps holder70 comprises afirst component72 that is able to slide over and alongtube12 and is provided withdetents74 for gripping a handle of the forceps. Twodetents74 are shown on opposite sides of acentral boss76. However in other configurations alternate numbers ofdetent74 may be provided. Theboss76 is provided with ascrew thread78 extending from across piece80 which contains thedetent74. Extending axially from thethread portion78 is asplit collar82. Theforceps holder70 also includes a lockingnut84 that is able to screw onto the threadedportion78 over thesplit collar82 and act to clamp thecollar82 onto an outer surface of thetube12 thereby releasably locking theholder70 at an outside location along thetube12. In one example, theforceps holder70 may be used to hold valsellum forceps which in turn holds themanipulator10 to the cervix making the manipulator self retaining.

With reference toFIGS. 12-14b, themanipulator10 may also support acervical funnel90 and aplug92. Thecervical funnel90 is formed as a unitary device comprising atube94 of constant inner and outer diameter and an integralconical portion96 which increases in outer diameter in a direction away fromfirst end16 oftube12. The conical portion is provided with alip98 that extends about a part of the circumference ofconical portion96 and is flared in a radial outward direction.

Plug

92 sits on the outside offunnel90 and when used in gynaecological procedures forms a plug in the vagina. With reference toFIG. 12, it can be seen that theforceps holder70 may also act as a positioning device for thefunnel90.

FIGS. 13aand13bdepict in greater detail thecervical funnel90 incorporated in themanipulator10 shown inFIG. 12. Thelip98 is flared outwardly by an angle θ of approximately 130° but may lay in the range of 130°-160°. In this embodiment the outermost edge of thelip98 extends for an arc a of approximately 115° about theconical portion96 but may lay in the range of about 100°-130°. An inside diameter of thetube94 is arranged to be slightly greater than the outer diameter of thetube12 to enable thecervical funnel90 to be rotatably and linearly moveable with respect to thetube12.

FIGS. 14aand14bdepict in greater detail thevaginal plug92 shown previously inFIG. 12. Theplug92 has amain body100 formed of a constant outer diameter and a contiguousdistal end portion102 of progressively reducing outer diameter tapering to thedistal end104 of theplug92. When theplug92 is used with themanipulator10, it is orientated so that thedistal end portion102 is directed toward thesecond fitting24. Aninterior surface106 of theplug92 has a first portion108 of constant inner diameter, and a contiguoussecond portion110 of progressively increasing outer diameter. More particularly, the surface of theportion110 is arranged to seat an exterior surface of theconical portion96 ofcervical funnel90. Thus the increase in inner diameter of the surface ofportion110 is substantially the same as the angle of increasing diameter of the outer surface ofconical portion96.

FIG. 15 depicts anoptional handle120 incorporated in embodiments of themanipulator10. Thehandle120 comprises agrip122 and acontiguous extension124. Theextension124 is provided with a throughhole126 and ascrew thread128. Thescrew thread128 extends from approximately the location of thehole126 to anend130 of thehandle120. The throughhole126 is dimensioned to enable thetube12 to pass there through either with a slight interference fit or a small clearance. Thus thehandle120 extends perpendicular to thetube12. Thescrew thread130 is configured to enable coupling with a nut such as asecond locking nut84. The locking nut when tightened onscrew thread128 can then act to clamp thehandle120 to thetube12. Thehandle120 can be applied to any portion of thetube12 between the

end fittings

22 and24 which is not otherwise covered by other components such as thecervical funnel90.

From the above description it will be recognised that dependant on the application at hand the manipulator may take many different forms owing the interchangability of first and second fittings and the ability to use additional components such as therod26, theforceps holder70,cervical funnel90 and theplug92. It is envisaged that a general uterine manipulator system or kit may be provided to surgeons and doctors composed of all or at least a selection of the first and second fitting; together with other components such as therod26,forceps holder70,cervical funnel90 and theplug92. In this way the surgeon or doctor will always have at hand various components to enable the performance of many different procedures.

FIGS. 16a-16dillustrate a further form of asecond fitting24bwhich primarily differs from the second fitting24aby the inclusion of an illumination device140. Features of the fitting24bthat have the same structure or function as the fitting24aare designated with the same reference numbers. In this embodiment the illumination device140 is in the form of a ring142 fitted to or otherwise supported at thedistal end56 of fitting24b. The illumination device140 enables light to be emitted from thedistal end56. In one form the ring140 is a ring of material embedded with one or more light emitting diodes (LEDs)124. In this embodiment ring142 may be made from a transparent acrylic resin. Power to the LEDs144 is provided via a cable146 that extends through thelumen64. In the embodiment thelumen64 may nevertheless be configured to also receive a telescope to enable visualization of the body cavity into which the fitting24bis inserted. In a variation of the illumination device140, the ring142 itself comprises a light guide that receives light from an optical fiber that passes through thelumen64. Light transmitted through the optical fiber enters and travels about the ring142 thus enabling the emission of light from thedistal end56.

FIGS. 17a-17cdepict a cervical funnel90awhich differs from thecervical funnel90 by the provision of a light emitting device140aenabling the emission of light formdistal end99 and more particularly from the 98 of the funnel90a. The funnel90ahas essentially the same physical structure as afunnel90 and accordingly includes a firstconical portion96 and integrally formedtube94. Thelip98 extends partly about anopening101 formed at thedistal end99. The illumination device140acomprises an arcuate transparent body142awhich may for example be made from of a transparent acrylic resin. Coupled to the body142ais an optical fiber146 which is arranged to transmit light from a source to the body142a. The body142ahas a configuration enabling it to be attached to thelip98 in a manner so as to form a substantially continuous surface of thelip98. The optical fiber146 extends can through a channel or hole148 formed in the funnel90a. In one embodiment, a channel or groove can be cut in the exterior surface of the body90ain which the optical fibre146 is laid. Thereafter the groove can be filled with a resinous material and smoothed, effectively encapsulating the fiber146 in the funnel90a. A coupling148 at the end of the optical fiber146 enables coupling with a light source or another optical fiber which carries light from the light source. In a variation to the illumination device140a, the body142amay have embedded therein one or more LEDs which when provided with electric current either: emit light directly from the body142a; or alternatively transmit light into thebody122afrom which it is emitted. In the event that thebody122acarries one or more LEDs, then theoptical fiber126 is replaced with a wire or cable to provide electrical power to the LEDs.

FIG. 18 illustrates amanipulator10 similar to that shown inFIG. 12 but with a modifiedcervical funnel90band amotor150 arranged to rotate thecervical funnel90bon, and relative to, thetube12. Themotor150 is held within ahousing152 which is supported on abracket154. Thebracket154 is a squared U shaped configuration with opposed arms. Themotor150 is attached to one of the arms and aclamp155 attached to the other arm. Theclamp155 can be operated to selectively grip and release thetube12. When theclamp155 is tightened it grips thetube12 preventing axial or rotational motion of thetube12.

Thecervical funnel90bis provided with a wave like outer surface profile on itstube94 as depicted most clearly inFIG. 19.Successive troughs156 andpeaks158 of the wave like profile act as rounded gear teeth about the periphery of tube94b. These engage with a complementary shapedannular gear160 driven by themotor150. When themotor150 is energized it rotates thegear wheel160 and, due to its engagement with the outer surface of the tube94b, causes thefunnel90bto rotate about and on thetube12. Due to the manner of engagement of themotor150 with the outer surface of thetube94, thefunnel90bcan be slid linearly along thetube12 while maintaining engagement with themotor150. Thebracket154 is attached to anarm162 that in turn can be clamped on to a stable support such as an operating table. A foot controlledswitch164 communicates with themotor150 via acord166. A surgeon is able to operate themotor150 by the foot operatedswitch164. The motor may be in the forms of a bi-directional stepper motor and the switch arranged to control the direction of rotation. The illuminatingdevice120adepicted inFIGS. 17a-17cmay also be incorporated with thefunnel90b.

FIGS. 20a-20cillustrate variations of a medical instrument that may be used with themanipulator10. InFIG. 20 themedical instrument170 comprises in effect the second fitting24aor24bformed back to back and integrally with thecervical funnel90 or90a. The

second fittings

24a,24bdiffers slightly from those previously described in that they does not comprise athread portion48 but rather have a through hole at theirproximal end172 that communicates with thetube94.Instrument170 may be considered as comprising abody174 provided with opposite first and

second end portions

176 and178.First end portion176 has afirst opening180 and thesecond end portion178 has asecond opening182. Athroughway184, constitute by thetube94 extends between the first and

second openings

180 and182 and is arranged to enable thebody174 to be supported on a shaft such as thetube12. With reference toFIG. 1a, if the end of themanipulator10 provided with thecervical screw24 is taken is the leading end, then theinstrument170 can be supported on thetube12 with either of the first and

second end portions

176,178 at the leading end of themanipulator10. Whichever of the

end portions

176 or178 is at the leading end will be inserted into the body cavity during a medical procedure.

In the embodiment inFIG. 20, it can be readily seen that the

end portions

176 and178 differ in one or more of their shape, size and configuration. In particular inFIG. 20, the

end portions

176 and178 differ in at least their shape and configuration.End portion176 has an outer diameter D1 measured in a plane of theopening180 while theend portion178 has an outer diameter D2 measured in aplane containing opening162. In this embodiment D1 may equal D2 or alternatively D1 and D2 may be different.

FIG. 21 illustrates an alternate form of medical instrument denoted as170acomprising an opposite first and

second end portions

176aand178arespectively joined by anintegral tube94. Each of the

portions

176aand178ais of the general configuration of theportion178 described inFIG. 20 but with different outer diameters D1 and D2. In particular in this embodiment D1 is less than D2.Instrument170awould be used in substantially the same manner as the second fitting24aor24b. However having the two end portions of different diameters D1 and D2 allows a medical specialist to simply use the end ofinstrument170awhich is dimensioned for the best suit the body cavity into which it is to be inserted.

FIG. 22 illustrates a form of themedical instrument170bin which the first and

second end portions

176band178bare both of the same general frusto conical configuration as thefirst end portion176 inFIG. 20. The difference between the

end portion

176band178bbeing their respective outer diameters D1 and D2. In this specific embodiment D1 is greater than D2. When theinstrument170bis used with the manipulator10 a medical specialist orientates theinstrument170bwith the

end portion

176bor178bat the leading end determined on the basis of the best match of outer diameter D1 or D2 to the vagina in to which it is to be inserted.

The instruments170-170bmay be considered to be double ended instrument as each of the end portions176-176band178-178 is configured to be inserted in a vagina or rectum.FIGS. 23a-23cillustrate a further form of double endedinstrument200 for insertion into a body cavity. Double endedinstrument200 comprises abody202 having afirst probe204aand asecond probe204b(referred to in general as “probe(s)204) at oneend206 and anopposite end208 respectively of thebody200. The same reference numbers will be use to denote the same features of each probe. Reference number that includes the suffix “a” relate to the features ofprobe204a; reference the number that includes the suffix “b” relate to the features ofprobe204a; and reference numbers with no suffix “a” or “b” refer the feature in general pertaining to either probe204aor204b.

Thefirst probe204ahas acylindrical portion210aof a firstcircumferential surface212ahaving an outer diameter Da. Probe204ais also provided with a firstcircumferential edge214aat thefirst end206 and afirst lip216aprojecting outwardly from the outercircumferential surface212aand beyond the firstcircumferential edge214a. Thefirst lip216aextends for a part of the circumference of theedge214a. Thelip216amay extend for between 100-130° of the circumference. This is akin to the angle α and the angular extent of thelip98 shown inFIG. 13c.

Thesecond probe204bhas the same general configuration as theprobe204abut with several differences including in dimensions of various aspects. Theprobe204bhas acylindrical portion210bwith an outercircumferential surface212bhaving an outer diameter Db. At theend208 theprobe204bis formed with a second circumferential edge214band asecond lip216b. Thesecond lip216bprojects outwardly from the outercircumferential surface212band beyond the second circumferential edge214b.

In this embodiment the diameters Da and Db are different from each other. In particular Da is >Db. In one example the diameter Da is about 40 mm while the diameter Db is about 30 mm. A further difference in the dimensions and configuration of the

probes

204aand204bis that thelip216bprojects at a greater angle θ with respect to its corresponding adjacent second outercircumferential surface212b. As a result thelip216bis inclined at a shallower angle to a central longitudinal axis of theinstrument200 thanlip216a. In a general sense, each of the lips216 projects at an angle θ relative to its adjacent circumferential surface212 where θ is in the range of 130°-160°. This is akin to the angle θ of thelip98 shown inFIG. 13b. However in this specific embodiment the angle of projection of thelip216ais about 140° whereas the angle θb for thelip216bis about 154°.

A further difference between the probes204 is the axial difference by which each of the lips216 project in the axial direction. Thelip216awhich is inclined at a steeper angle than thelip216bprojects in an axial direction from a location immediately adjacent the outercircumferential surface212aby a length La. The length La is different to and shorter than the length Lb of axial extent of thelip216b. In one specific example, the distance La may be in the order of 9 mm where the distance Lb may be in the order of 13 mm.

Probe214ais provided with an internal cavity220aof circular cross section and having aninner diameter222a. The outercircumferential edge214ais formed by tapering or flaring the material of theprobe204aat theend206. The angle of the taper is shown as angle β inFIG. 23band may lie in a range of 110°-140°. However in this specific embodiment flaring angle β is 130°.

The internal configuration of theprobe204bis generally the same as that ofprobe204abut with different dimensions. Specifically, theprobe204bhas an internal cavity220bwith an internal diameter222bwhich is not the same as and more particularly smaller than theinternal diameter222a. In one example thediameter222ais about 35 mm and the diameter222bis about 35 mm. Theprobe204aat theend208 is also tapered to reduce in thickness at an angle13bwhich is different to and in this embodiment less than the angle βb. In one example, the angle βb may be 116°.

Theprobe200 is formed so that the lips216 have respective circumferential

mid points

224aand224bthat are in axial alignment. Thus when one probe204 is inserted into a body cavity with the other probe outside of the cavity, a surgeon is able to easily visualize the position of the lip on the inserted probe by simple reference to the position of the lip of the non-inserted probe. The arcuate extend of the lips216, i.e. the angles αa and αb can be arranged to be the either the same or different. However in this specific embodiment the angle αa>αb.

The double endedprobe200 is also formed with anintermediate portion226 that smoothly transitions between the

probes

204aand204b. Theprobe226 has acentral region228 which is necked and has an outer diameter less than each of the diameters Da and Db. Thus, the outercircumferential surface230 of theintermediate portion226 has a concave profile. In one example the overall length of theprobe200 is about 230 mm with each probe204 having a length of 85 mm and the intermediate portion having a length of 60 mm.

As shown most clearly inFIG. 23b, theintermediate portion226 is formed with aninternal bore228 that extends in an axial direction between and providing fluid communication with the first and second cavities220aand220b. Thebore228 enables the double endedinstrument200 to be supported on themanipulator10 and in particular thehollow tube12 in the same manner as thefunnel90 and the

medical instruments

170,170aand170b.

In a general sense, the double endedmedical instrument200 comprises a combination of theinstrument170ashown inFIG. 21 but with the addition of thefunnel lips98 and a reshaping and smoothing of thetube98 and respective adjacent back ends of the

portions

176aand178a.

FIGS. 24a-24cdepict a further embodiment of a double ended medical instrument. In this embodiment the double ended medical instrument is denoted by thereference number300. Themedical instrument300 is a modified form of themedical instrument200. All features of themedical instrument300 that are the same as those of themedical instrument200 are denoted with a reference number incremented by 100. For example, the probes of themedical instrument300 are denoted by the

numbers

304aand304b, the lips are denoted by the

reference numbers

316aand316band the intermediate portion is denoted by the reference number326. Also as with the numbering convention for theinstrument200, reference number that includes the suffix “a” relate to the features ofprobe304a; reference the number that includes the suffix “b” relate to the features ofprobe304a; and reference numbers with no suffix “a” or “b” refer the feature in general pertaining to either probe304aor304b.

The double endedmedical instrument300 differs from the double endedmedical instrument200 solely by the provision of aplatform350aon theprobe304a; and aplatform350bon theprobe304b.Platform350ahas a constant first outer diameter extending over thecylindrical portion310a. More particularly, theplatform350ahas an outercircumferential surface352athat is concentric with the outercircumferential surface310abut of a greater radius. Theplatform350aextends rearwardly from the outer circumferential edge318aof the corresponding lip314a. Also in this example the circumferential extent of theplatform350ais the same as that of theunderlying lip316a. Theplatform350aextends in an axial direction toward thesecond probe304b. Thereafter, the platform smoothly transitions from itsrearward edge354ato thecircumferential surface310a. This transition forms aramp356abetween the outer

circumferential surfaces

352aand310a.Opposite sides356aand358aof theplatform350atransition smoothly to the outer circumferential surface318a. Indeed rounded surfaces can be provided between the outercircumferential surfaces352aand thesides356aand358a.

In this embodiment, the length Pa, that is the axial length of theplatform350ais in the order of 20 mm. While this distance may be varied and in particular extended the significance of the 20 mm length will be described in greater detail below. Suffice to say that it is possible to increase this length to say 30 or 40 mm and have tactile markers for example circumferential ridges or circumferential grooves at various set distances or lengths such as 20 mm, 25 mm, 30 mm, 35 mm.

Theplatform350bis of the same general shape and configuration as theplatform350a. However the radius of theplatform350bis different to and in this embodiment smaller than the radius of aplatform350a. Further, as the lip314bis formed with a smaller arc angle αb, the circumferential width of theplatform350bis smaller than that ofplatform350a. However, the axial length Pb of theplatform350bin this embodiment is the same as the length Pa.

Each of the double ended

medical instruments

200 and300 maybe used in laparoscopic gynecological surgery and in particular, for laparoscopic hysterectomy. Theinstrument200 may be considered as a “standard” model and theinstrument300 as an “oncology” model.

Each of the

medical instruments

200 and300 can be slid over the uterine manipulator and in particular thetube12 as described herein above in relation to the

instruments

170,170aand170b. The specific probe which is inserted is simply dependent upon the size of the cavity at hand. An advantage or benefit of the

instruments

200 and300 over say theinstrument170bshown inFIG. 22 is that as theprobe204 or304 is of a cylindrical shape rather than in the form of a frusto conical funnel, the outer surface210 can act as a stopper in say the vaginal cavity to prevent leakage of CO₂gas. Thus the probes204 may be considered as integral functional combination of theinstrument170bshown inFIG. 22 together withrespective plugs92. In this way theinstrument200/300 can replace theinstrument170bandrespective stops92 for each of the

portions

176band178bof theinstrument170b.

The lips216/316 function as previously described to present the vaginal vault tissue for incision. After a hysterectomy is performed and the uterus is delivered through the vagina, usually an appropriate sized probe is inserted to prevent CO₂leakage. This function is now performed as mentioned before by the provision of the cylindrical probes204/304. A suture needle can be placed in the cavity220/320 of the inserted probe204 to be picked up by a laparoscopic needle holder to subsequently suture the vaginal vault.

Theinstrument300 by virtue of the provision of theplatforms350 may be used in oncology procedures relating to cervical cancer. When cervical cancer is detected in the early stages, common procedure is to remove a 20 mm cuff from the vagina to adequately excise cancer tissue. Usually there is no indicator of how much margin to incise apart from the surgeon's subjective perception of adequate cuff removal. Theinstrument300 provides aplatform350 of known length for example 20 mm to indicate to the surgeon the line of incision to remove an adequate margin of vaginal cuff. By rotating thelip314 the vaginal margins are freed from the bladder anteriorly, the uterine vessels laterally and the rectum posteriorly, ensuring that these important structures are clear from the vaginal cuff before the vaginal incisions are made. The principles and functions of theinstrument300 is the same as thestandard instrument200 after the uterus and cervix is removed.

To the best of the Applicant's knowledge there is no vaginal marker colpotomizer available to accurately measure the vaginal margin of clearance that is required for gynecological oncology cases both in laparoscopy and open incision or laparotomy surgery. If too much vaginal tissue is removed the shortened vagina will make intercourse uncomfortable. Conversely, inadequate margins will result in cancer recurrences. Current practice is to gauge the depth of vaginal margin by estimation, and every surgeon has their own estimation method. Embodiments of theinstrument300 provide an accurate measuring tool for adequate vaginal margin removal to ensure the patient has the best clearance result and the best chance to have a functioning vagina. Theplatforms350 provide a hard surface to push away the bladder anteriorly and the rectum posteriorly. Thelips314 ensure adequate ureteric displacement. The vagina is dissected at the edge of the platform250. This can be performed in a number of different ways including but not limited to:

(a) a knife cutting along the end of theplatform350;
(b) cautery or cutting current being applied by a hook electrode or sharp scissors to the edge of theplatform350;
(c) harmonic scalpel energy to incise the vagina at the edge of theplatform350;
(d) a recessed trough at an edge of theplatform350 to guide vaginal incisions;
(e) by providing a hole near an edge of theplatform350 into which an electrode, monopolar or bipolar is inserted. In this event by rotating theinstrument300 the vagina is incised by the energy source being applied.

FIG. 26 depicts one end only of a further embodiment of a double endedmedical instrument300′ which differs from theinstrument300 by virtue of itsplatforms350′ and thelips314′ that extend for the full circumference of therespective probe304′. (The opposite end of theinstrument300′ is of the same general configuration as shown inFIG. 26 but with theprobe304′ at that end being of a different dimension akin to the differences between

probes

204aand204b; or304aand304b.) Theinstrument300′ can be used in laparotomy or open surgery. In these cases, the platform can be directly palpated hence there is no need to rotate thelip314′/platform350′ to visualize the margin as in laparoscopic surgery. By a direct palpitation the vaginal margin is reflected before incisions are made to remove a desired length of vaginal cuff, for example 20 mm.

As mentioned hereinbefore, the platform of the

instrument

300 or300′ used in laparotomy or open surgery can be provided with an axial length P greater than say 20 mm with palpatible markings such as circumferential ridges or grooves at set lengths or distances to provide an indication of a precise length of vaginal cuff for incision. This is shown for example inFIGS. 24d-24gwhere markings M1-M4 are provided on theplatform350 at spacings of 20 mm, 25 mm, 30 mm, and 35 mm from the outer edge of associatedlip316. InFIG. 24ethe markings M are ridges, inFIG. 24fthe markings M are grooves, and inFIG. 24gthe markings M comprise sets of immediately adjacent circumferential grooves and troughs. The double ended medical instrument with the platform and lip that extend wholly about therespective probes304 may be termed as the laparotomy double ended instrument.

In the case of sacrocolpopexy where the bladder and rectum are reflected back to facilitate placement of mesh on the vagina, theplatforms350/350′ in both the oncology and laparotomy double ended medical instrument provide a solid dissecting base. However in the event of use of the oncology double endedmedical instrument300 rotation may be required in order to place theplatform350 in the appropriate location. Clearly no rotation is required for the laparotomy double endedmedical instrument300′.

A double ended plug370 shown inFIG. 25 can be used with the either of the standard, oncology or laparotomy double ended medical instrument. The plug has an axially aligned and opposite cylindrical stems372 of a diameter that provides a light interference fit with the inner circumferential surface at one end of thebore228,328 of the intermediate portions. Between the stems372 is a large diametercylindrical portion374 and an intermediate diametercylindrical portion376. Theportion374 is dimensioned to form a light interference fit with thecavity220a, or320a; andportion376 is dimensioned to form a light interference fit with thecavity220b,320bof the

probes

204bor304b. The plug when fitted into the corresponding end of the medical instrument forms a fluid seal at that end of the seal. Naturally the plug370 can only be used when the double ended instrument is not supported on themanipulator10. It is envisaged that theplug300 would be used to assist in maintaining pneumoperitoneum when the double ended instrument is used without themanipulator10. In exactly the same way the plug370 can be used with any one of the instrument s,170,170aand170bshown inFIGS. 20-22.

FIGS. 27a-27dillustrate a further variations to thecervical funnel90c. Thefunnel90cis of the same general shape and configuration and works in the same way asfunnel90, but differs by the provision of a throughhole190 in thelip98. The throughhole190 is provided mid way along the arc of thelip98. Optionally thefunnel98 may also comprise anillumination device192. In this embodiment theillumination device192 is in the form of an annular light guide coupled to an optical fiber. The annularlight guide192 surrounds the throughhole190. When the optical fiber is coupled to a light source the light is guided by thefiber194 to the annular light guide and illuminates the annularlight guide192 providing a ring of light about thehole190. The annularlight guide192 can be in the form a transparent acrylic resin ring. Theoptical fiber194 can be embedded/encapsulated in a groove formed along the cervical funnel90d.

Thehole190 is dimensioned to receive the tip of an electrical cautery probe. During say a hysterectomy the probe is inserted into thehole190. It is believed that thehole190 will ordinarily be easily visible or locatable by a surgeon. However the provision of theillumination device192 will assist in visually locating thehole190. The electrical cautery probe is inserted through the vagina wall (which is being lifted by the lip98) and into thehole190. By applying electric current and rotating the funnel90da very clean and precise circumcision can be made of the vaginal wall to separate it from the cervix.

The throughhole190 may also of course be incorporated in every other form of cervical funnel described hereinbefore. As can the annularlight guide192.

Now that an embodiment of the invention has been described in detail it will be apparent to those skilled in the relevant arts that numerous modifications and variations may be made without departing from the basic inventive concepts. For example, in one embodiment, thehydrotubation port42 is illustrated and described as being formed on thefirst fitting22. However in an alternate embodiment, a hydrotubation port may be formed on thetube12 at a location nearfirst end16 but beyond the screw thread T1. In one embodiment, the first and

second fittings

22,24 may be formed from a plastics material so as to be disposable after a single use while the elongatedhollow tube12 may be made from surgical grade stainless steel so as to be reusable. Also as would be readily apparent to one of ordinary skill further double ended instruments may be constructed using combinations end portions or probes shown inFIGS. 20-26 of the same or different size. For example a double ended instrument could comprise: aprobe204aat one end and aprobe304aat another, where the probes are of the same or different outer diameter; aprobe204aat one end and aprobe304aat another, where the probes are of the same or different outer diameter; anend portion176aat one end and aprobe204bat the other, where the probes are of the same or different outer diameter; etc. All other combinations of the currently disclosed probes and end portions are possible. All such modifications and variations together with others that would be obvious to persons of ordinary skill in the art are deemed to be within the scope of the present invention the nature of which is to be determined from the above description and the appended claims.