GB2452561A

GB2452561A - Bougie with illuminating and imaging means

Info

Publication number: GB2452561A
Application number: GB0717543A
Authority: GB
Inventors: David Ernest Young; Eric William Abel
Original assignee: Sentient Medical Ltd
Current assignee: Sentient Medical Ltd
Priority date: 2007-09-10
Filing date: 2007-09-10
Publication date: 2009-03-11
Also published as: GB0717543D0

Abstract

A bougie 10 for dilating strictures and stenoses in humans and animals comprises a distal introducer portion 12, a dilator portion 16 proximal to the introducer portion 12, an elongate body portion 18 proximal to the dilator portion 16, a proximal portion 20, at least one imaging means (28), at least one light source 30, a power supply, supporting electronic circuitry and external imaging equipment including monitoring means. The dilator portion 16 may be continuous with the distal introducer portion 12 and the elongate body portion 18. The bougie 10 may be provided with a wireless transmitting module. The external imaging means may be connected by wireless means. The imaging means may be a CMOS camera chip or a CCD device.

Description

I

BOUGIE

Field

A bougie is a substantially cylindrical and most usually flexible surgical instrument that is inserted into a body canal to dilate a stricture (sometimes referred to as a stenosis) or blockage in the esophagus, the intestines, blood vessels, the ureters, the urethra and other tubular or hollow structures. A stricture is an abnormally narrow section of such a structure while a blockage is an obstruction within such a structure. Some bougies are hollow, some employ balloons for achieving dilation and some have a light source for transillumination of the wall of the structure.

Background To The Invention

The bougie of the present invention has a distal introducer portion which may vary from minimal to quite extended in length and which is substantially continuous with a dilator portion, proximal to the distal introducer portion. Proximal to the dilator portion, and substantially continuous with it, is provided an elongate body which terminates proximally in a proximal portion. The form of the bougie may be substantially continuous overall from the distal extremity to the proximal extremity. The present invention incorporates a camera.

advantageously but not necessarily into the distal introducer portion so that, as the target is approached with the bougie, the operator may observe the stricture or stenosis which it is desired to dilate and pass through. This reduces the likelihood of the instrument rupturing the walls of the vessels along which the bougie has to pass as dilation proceeds. The intention is that the entire bougie would be used once and then disposed of, thereby eliminating the risk of cross infection associated with re-usable devices.

Prior Art

Bougies in many forms have been well known and widely used since at least the 18 Century. The use of bougies is usually a blind' procedure where the operator is unable to see the tip of the instrument, consequently the rupture of the walls of the vessel through which the instrument is passed is not uncommon and can be exceedingly dangerous or even fatal.

Various methods and modified devices have been used to overcome this problem. For instance, the introduction of fluoroscopic medium through the bougie to allow continuous radiographic observation of the instrument within the body has been widely used.

However, this approach has the disadvantage of inherent risks associated with the exposure of the patient and medical team to radiation. Transilluminating devices have also been proposed, such as that disclosed by Angetchik in US 5,624,432 but this is intended to illuminate tissue alongside the bougie. The device is described in the context of a laparascopic procedure and the intense light illuminates the organ from within, the outside of the organ being under direct vision via a laparoscope; it does not teach any possibility for viewing the interior of the organ during the use of the bougie.

Accordingly, there remains an important unmet clinical need for bougies which mitigate or remove the risk of serious damage and trauma to the vessels into which they are introduced and thus to patient, preferably by allowing the operator to directly observe the target region and thereby exercise judgement and skill to optimise the outcome of dilation procedures.

Outline Of The Present Invention According to a first aspect of the present invention there is provided a bougie for use humans and animals having a distal introducer portion having a blunt distal tip and being advantageously of circular cross-section. The distal introducer portion may be of various shapes and may be, for example, provided with a gradually increasing diameter so as to be substantially continuous with the dilator portion wherein the diameter of the instrument reaches a maximum. The distal introducer portion may also vary in length from a few centimetres long to being effectively part of a forward tapered part of the dilator portion.

The dilator portion may also have a decreasing taper proximally and may be continuous with the elongate body of the bougie which may be of any appropriate length, terminating in a proximal portion which is not introduced into the body of the subject. According to the application, the bougie may be flexible, rigid or semi-rigid and may be made in suitable plastic or rubber derivatives such as silicone rubber or polyurethane or if rigid may be made in metals, for example, stainless steel or titanium.

According to a second aspect of the bougie according to the present invention, there is provided at least one light source, preferably though not necessarily, a light emitting diode (LED) light source and at least one imaging device such as a camera advantageously, though not necessarily, a small example of the CMOS type or a CCD device and in certain versions optical devices may be appropriate. The light source and camera may be powered either by a local battery source located distally or proximally within the bougie. If the battery is proximal, suitable conducting means are provided from the location of the light source and camera to the proximal portion of the device. If an external power source is used, connecting means in the form of wires are used to provide connection to either an external battery or a mains power source, usually if the latter, via a low voltage transformer.

The light source and camera are supported by suitable circuitry including image encoding means. The at least one light source and at least one imaging device together with a suitable battery and circuitry may be advantageously mounted together in the introducer portion of the bougie and or in the dilator portion. Alternatively, even when the light source and imaging device are located in the introducer portion, the battery means together with the circuitry may be located in the dilator portion. A further alternative is that the power source may be mounted proximally or even outside the bougie. Image signal decoding is provided at any convenient location and monitor visual display means are provided external to the body of the subject.

Housing means conveniently in the form of a substantially cylindrical housing, preferably made from stainless steel or in suitable hard medical grade plastics, are provided for the at least one camera and at least one light source and where required, the same housing may accommodate a battery, an RF wireless transmitting module and supporting circuitry.

When single housing means is employed the preferred location is at or near the distal tip of the distal introducer portion. When a plurality of housings is employed, imaging and illumination means are preferably located in a first housing in the distal introducer portion of the bougie and the remaining components are housed in a second housing, preferably located proximally. Support circuitry may include image encoding and compression means where appropriate. When a single housing is accommodated within and attached to the distal introducer portion of an instant bougie made of plastics, attachment means may be in the form of adhesive means which may be a discrete adhesive or may involve a heat-sealing process where the thermal and mechanical properties of the selected material from which the bougie is made are employed. When the bougie is made of metals, attachment means may be in the form of adhesive means or mechanical means. Alternatively, the distal introducer portion or the dilator portion of the bougie may be adapted to receive and retain the housing means compressively, for instance by a suitable forming, tapering or narrowing of the bougie.

According to a third aspect of the invention a bougie has a distal introducer portion, an elongate body and a proximal portion, substantially as hereinbefore described, and a dilator portion which incorporates an inflatable circumferential balloon whereby the diameter of the dilator portion may be selected by inflation of the balloon during use according the prevailing surgical need.

According to a fourth aspect of the bougie according to the present invention, the proximal portion, elongate body portion, dilator portion and, if appropriate part of the distal introducer portion, may be advantageously made hollow and be suitably adapted to receive steering means in the form of an introducer, which may or may not be mutually threadedly attachable to distal housing means or the bougie may be introduced using other steerable and extendable means. Alternatively, an introducer may be incorporated into the bougie at the time of manufacture.

According to a fifth aspect of the bougie according to the present invention, the instrument may be constructed sufficiently inexpensively such that where appropriate it may be used then disposed of thereby obviating the risk of infection associated with attempts to re-sterilise tubular instruments which have been introduced into mammalian bodies.

Oblects Of The Invention Accordingly it is an object of the present invention to provide a bougie comprising a distal introducer portion, a dilator portion, an elongate body and a proximal portion. The distal introducer portion or dilator portion is provided with at least one imaging means and at least one light source means for illumination and imaging of a stricture or stenosis in body cavities, hollow organs and vessels during the practice of human and veterinary medicine, the device generally being flexible, rigid or semi-rigid and capable of being rendered sterile prior to use.

It is another object of the present invention to provide a bougie wherein the dilator portion is in the form of a circumferential inflatable balloon.

It is a further object of the present invention to provide a bougie incorporating at least one imaging means and at least one light source means which. The bougie, during use, may be mounted upon and deployed by introducer means or using an extendable and steerable mechanism; It is a further object of the present invention to provide a device comprising a bougie with at least one imaging means and at least one light source means which may be made sufficiently simple and inexpensive such that it may be discarded following a single deployment and use, thereby substantially eliminating the risks of cross infection associated with resterilisation of tubular surgical instruments (Rutala & Weber, Infection Control and Hospital Epidemiology, Volume 28(2007), pages 146 -155).

Brief Description Of The Drawings

Further preferred features and advantages of the present invention will appear from the following detailed description of two embodiments illustrated with reference to the accompanying drawings in which: FIg. 1, is a schematic lateral view of a bougie having a distal introducer portion with first distal housing means, a dilator portion, an elongate body and a proximal portion provided with second proximal housing means and having imaging and illumination means according to a first preferred embodiment of the present invention; FIg. 2, is a diagrammatic longitudinal interrupted sectional view of the bougie of Fig. 1, showing connecting wire means arranged intramurally; Fig. 3, is a diagrammatic longitudinal interrupted sectional view of the bougie of Fig. 1, showing connecting wire means arranged extramurally on the inner aspect; Fig. 4, is a schematic interrupted top view of a bougie having a distal introducer portion, a dilator portion, an elongate body and a proximal portion and having imaging and illumination means with wireless capability; all electronic and electrical components being housed in a single distal housing located within the distal introducer portion and showing a switch position with a broken line, all according to a first preferred embodiment of the present invention; Fig. 5, is a diagrammatic longitudinal interrupted sectional view of the bougie of Fig. 4, indicating single distal housing means for imaging and illumination means and ancillary components but with numbers for most components omitted for clarity; FIg. 6, is a diagrammatic longitudinal interrupted sectional view of the bougie of Fig. 4, indicating single distal housing means for imaging and illumination means and further indicating introducer means within the lumen. Numbers for most internal components have been omitted for clarity; Fig. 6a, is a diagrammatic longitudinal interrupted sectional view of a solid bougie according to a first preferred embodiment of the present invention, indicating single distal housing means for imaging and illumination means and further indicating integrated introducer means. Numbers for most internal components have been omitted for clarity; Fig 7, is a diagrammatic enlarged interrupted partial longitudinal sectional view of a bougie according to a preferred embodiment of the present invention and showing details of distal housing means and components housed therein and proximal housing means and components housed therein; Fig 8, is a diagrammatic enlarged partial longitudinal sectional view of the distal introducer portion of a bougie showing a single distal housing located within a distal introducer portion and housing an electronics module. The single distal housing also has threaded receival means together with threaded introducer means according to a first preferred embodiment of the present invention; Fig. 9, is a diagrammatic lateral view of a bougie according to the present invention having wireless capability and wherein a substantial portion of the elongate body portion has an accordion or bellows structure to facilitate deployment and wherein is provided an obturator proximal portion; Fig. 10, is a diagrammatic longitudinal sectional view of the bougie of Fig. 9, indicating narrow introducer means within the lumen of the bougie. A distal housing and components are also shown but with numbers for internal components omitted for clarity; Fig. 11, shows the bougie and introducer of Fig. 9 with the introducer pushed distally whilst the proximal portion of the bougie has been restrained by the obturator proximal portion; Figs. 12 and 13, indicate the capacity of the bougie and introducer of Fig. 11 to accommodate tight radii; Fig. 14, is a schematic lateral view of a bougie according to the first preferred embodiment and incorporates a block diagram of image processing means and image monitoring means to which the bougie is connected by wireless means; Fig. 15, is a longitudinal diagrammatic interrupted sectional view of a bougie according to the first preferred embodiment and incorporates a block diagram of an external power source, image processing means and image monitoring means to which the bougie is connected by wire means; FIg. 16, is a schematic lateral view of a bougie having a distal introducer portion of more conical shape than that of Fig. 1, wherein camera means are placed at the extreme distal tip and illumination means are located substantially at a point where the distal introducer portion merges with the dilator portion; FIg. 17, is a schematic lateral view of a bougie having a distal introducer portion which is reduced in extent in comparison than that of Fig. 1; FIg. 18, is a schematic lateral view of a bougie having a distal introducer portion which is reduced in extent in comparison than that of FIg. 1; and where a distal taper of the dilator portion constitutes the distal introducer portion; Fig. 19, is a schematic lateral view of a bougie according to a second preferred embodiment of the present invention wherein a dilator portion comprises an inflatable circumferential balloon structure shown in a non-inflated condition; Fig. 20, is a diagrammatic longitudinal sectional view of the bougie of Fig. 19, showing details of an inflatable circumferential balloon structure and inflation channel therefor; Fig. 21, is a schematic lateral view of the bougie of Fig. 19, according to a second preferred embodiment of the present invention wherein the circumferential balloon structure is shown in an inflated condition;

Detailed Description Of Preferred Embodiments

A bougie 10, for use in human and veterinary medicine, according to a first preferred embodiment of the present invention, is described with general reference to Figs I -18.

The bougie is generally intended to be used sterilised.

In the following descriptions, internal electronic and electrical components and housing means therefor may best be referenced to Fig 7 and Fig 8.

In a first preferred embodiment of the present invention, bougie 10, is for deployment upon any suitable introducer means, including plain and threaded introducers and the extendable and steerable portion of suitable steering means (not separately illustrated).

In Fig 1, it may be seen that bougie 10, has a distal introducer portion 12, having a first end at distal tip 14, which is desirably blunt and is advantageously of substantially circular cross-section. Distal introducer portion 12, may have a substantially constant diameter as may be seen by reference to Figs 1 -6, for example, or it may be provided with a gradually increasing diameter as may be seen by reference to Fig 16. Distal introducer portion 12, is advantageously continuous with dilator portion 16, wherein the diameter of bougie j.Q, tapers to a maximum.

Distal introducer portion 12, may be of various shapes and may, for example be substantially a blunt conical shape as is shown in FIg. 16. Distal introducer portion 12, may also vary in length from a few centimetres long as indicated in Fig 17, to being effectively subsumed as part of a forward taper within dilator portion 16, as illustrated in Fig. 18.

Dilator portion 16, has a tapering decrease in diameter proximally and, in this first preferred embodiment, is substantially continuous with elongate body portion 18, of bougie jQ.

I

Elongate body portion 18, is substantially continuous with proximal portion 20, and terminates at a second proximal end 22. As indicated in Figs 2 and 3, for example, most versions of bougie jg, advantageously but not necessarily have a hollow lumen 24, open only at second proximal end 22, The overall length of bougie 1Q, varies according to the particular surgical indication for which bougie iQ is to be used and the main determinant of length is variation in the length of elongate body portion 18, which may be up to several hundred millimetres long. The diameter of prior art bougies varies widely according to the intended surgical indication and the maximal diameter is normally expressed in either French gauge or millimetres. In the case of bougies according to the present invention the diameter measured at dilator portion 16, may vary from a few millimetres to a several centimetres.

Rigid versions of bougie 10, may be made in suitable metals such as stainless steel or titanium. Flexible versions of bougie jQ, may be made in suitable plastics or rubber derivatives such as silicone rubber or a urethane. Materials be advantageously combined to provide a wide range of handling characteristics, including semi-rigid versions. For example, as may be seen by reference to Fig. Ga, a silicone rubber bougie, according to the present invention, may have a braided wire reinforcement deployed axially effectively also providing introducer means 66; in this version lumen 24, is absent. Alternatively, a spiral wire or carbon fibre filament deployed substantiafly circumferentially within the body of bougie jQ (not illustrated). When made in metals bougie j, may be made, for example, by processes such as machining, and when made in plastics or rubber derivatives bougie jQ, may be made, for example, by moulding processes.

As may be seen by reference to Figs. 9 -13, bougie jQ, may optionally have an accordion (which may alternatively be described as a bellows or concertina) construction 26, along at least part of the length of elongate body portion 18, to facilitate general deployment and particularly negotiation of tight radii. In the version of bougie jQ, shown in Figs 9 -13, an obturator, releasably lockable by screw means, constitutes proximal portion 20, and this feature is provided so that, once bougie 10, has been steered into position, using introducer means 62, the resultant shape of bougie iQ may be constrained against 62.

Bougie jQ, is provided with at least one imaging means 28, preferably a small CMOS camera chip, preferably accommodated within distal introducer portion 12, near blunt distal tip 14, which constitutes a first end of bougie 10, together with at least one light source means 30, preferably but not necessarily a LED light source which may emit white or monochromatic light. It should be noted that other types of imaging device such as a charge coupled device (CCD) or an appropriate optical device may be selected for use in either of the preferred embodiments described herein.

Versions of bougie jQ, may be made in which all electronic and electrical components are housed in single housing, located distally.

Alternatively, versions may be made where the at least one imaging means and at least one light source means are located in a first distal housing with power supply means and switch means located in a second housing located proximally.

Furthermore, versions of bougie 10, may be made which are connected wirelessly to external image processing means and monitor means.

In addition, versions may be made which are connected by wire means to an external power supply, image processing means and monitor means.

Accordingly, and by way of example, In FIgs 4-6, 8, and 9 -13, there are shown wireless versions of bougie 10, in which all electronic and electrical components are housed in single distal housing 32. A wireless transmitter module 34, such as a Bluetooth" device, a battery 36, supporting electronic circuitry (which may include image encoding means where appropriate) and a press-for-on switch 38, conveniently proximal to light source 30, and imaging device 28, are all assembled as single electronics module 40, accommodated within single distal housing 32, located within distal introducer portion 12, near first end distal tip 14. A lens 42, is provided over the active face of imaging means 28. Connection between the electronic components may be achieved using a small PCB means or other convenient direct contact means (not separately illustrated). Single distal housing 32, is conveniently made in stainless steel by a process such as machining, or in hard medical grade plastics, such as a suitable grade and thickness of a styrene compound by a process such as injection moulding. The effect of the presence of single distal housing 32, is to close off lumen 24, of bougie 1Q1 in the region of distal introducer portion 12, and first end blunt distal tip 14.

When bougie j.Q, is made of plastics or rubber derivatives, single distal housing 32, may be accommodated within and be attached to distal introducer portion 12, of bougie jQ, by adhesive means which may be a discrete adhesive or may involve a heat-sealing process where the thermal and mechanical properties of the selected material from which bougie jQ, is made are employed. When bougie j, is made of metals, attachment means may be in the form of adhesive means or mechanical means. Alternatively, distal introducer portion 12, or dilator portion 16, of bougie 10, may be adapted to receive and retain single distal housing 32, compressively, for instance by a suitable forming, tapering or narrowing of the bougie (not separately illustrated).

In relatively soft versions of bougie 10, made of plastics or rubber derivatives, switch 38, may be conveniently located beneath the surface 44, and within the substance of distat introducer portion 12, of bougie 10, at a position peripheral to electronics module 40, of bougie j*Q, such that 38, may be operated by pressure at 44.

Battery 36, may be any convenient small non-rechargeable type, however a bank of two or three small zinc-air cells of the coin' type, widely used in small portable devices, such as hearing aids, is preferred for internally powered versions of bougie 1Q. The use of such a battery is possible because the applications in which the instant bougie is likely to be used are generally not very protracted procedures and bougie j*Q, will usually be constructed for single use, following which it is intended to be discarded. It is to be understood that other power sources are suitable for the present invention and include such devices as supercapacitors. Employing two or three zinc-air cells in battery 36, of bougie j2 will generally provide sufficient power, following switch-on, to produce adequate light and produce good quality images for the duration of most procedures. Service life may be increased by the addition of one or two more cells with little penalty in terms of mass or space occupation. Alternatively an external power source may be used as hereinafter described.

It is to be understood that the portion of single distal housing 32, housing at least one light source 3D, may be adapted to provide local reflective chamber means for 30. This includes versions of bougie 10, comprising a plurality of light sources (such as an array) and all figures so labelled are drawn to indicate this intention. This intention applies not only to all versions of the first preferred embodiment but also to all versions of the second embodiment hereinafter disclosed.

Referring now to Fig 14, which includes the bougie of Fig. 4, made of substantiafly soft materials and having a single distal housing 32 (not seen directly). In this top view, the position of switch 38, may be seen indicated with a broken line at 44, on distal introducer portion 12. Operation of switch 38, by pressing at 44, causes power from battery 36 (not seen), to be delivered to the components of electronics module 40 (not seen), including wireless transmitter module 34, thereby wirelessly connecting to a remote wireless receiver 46. Wireless receiver 46, may be a Bluetooth enabled receiver, connected to a suitable monitor 48, having image signal decoding means, and located outside the body in a position where, in use, monitor 40, may be readily observed by the operator. However, it should be noted that in all versions of bougie jQ, and in the second preferred embodiment, hereinafter described, image signal processing means may be located elsewhere at any convenient place.

In Figs I -3a, 7, 15 -18, there are shown wireless versions of bougie 10, in which at least one imaging means 28, and at least one light source means 30, are located in a first distal housing 50, located in distal introducer portion 12, and the remaining electronic and electrical components including, wireless transmitter module 34, battery 36, and press-for-on switch 38, are housed in a second proximal housing 52, located near proximal end 22, of proximal portion 20. First distal housing 50, and second proximal housing 52, are conveniently made from the same materials and in the manner as hereinbefore described with reference to single distal housing 32, though 50, and 52, are not generally the same shape. Similarly, the effect of the presence of first distal housing 60, is to close off lumen 24, of bougie 10, at distal introducer portion 12, in a manner substantially similar to that of single distal housing 32, and means of attachment thereto is also substantially similar.

The components housed in first distal housing 50, namely imaging device 28, and light source 30, are linked to those in second proximal housing 52, by suitable connecting wires 54; 56. As hereinbefore indicated, that portion of distal housing 32, housing at least one light source 30, may be adapted to provide local reflective chamber means for 30.

Supporting electronic circuitry may be housed in either of 50, or 52, and may include image encoding means where appropriate.

When bougie 10, is made of plastic or rubber derivatives, second proximal housing 52, may be attached to proximal end 22, of proximal portion 20, of bougie 1Q1 by adhesive means or, if bougie 10, is moulded 52, may be incorporated into the mould. When bougie Q, is made of metals 52, ma y be attached adhesively or it may be attached by mechanical means.

As may be seen in Figs 2 and 3, connecting wires 54; 56, may be incorporated intramurally into bougie 1Q1 or may be attached adhesively with adhesive means or any other suitable means, extramurally, to bougie 10, on its inner aspect. Although it is also technically feasible to attach connecting wires 54; 56, extramurally on the outer aspect, this is inadvisable in an organ or other structure because of the potential to cause mural damage where a stricture is or may be present.

Alternatively and optionally, as may be seen by brief reference to Fig 3a, wires 54; 56, may be led unattached, running for instance within hollow lumen 24, of bougie 10, from first distal housing 50, to second proximal housing 52, which may, optionally, itself be unattached to bougie 10, with wires 54; 56, constituting a flying lead.

Wireless connection for versions of bougie jQ, having first distal housing 50, and second proximal housing 52, to wireless receiver 46, and monitor 48, having image signal decoding means are substantially as hereinbefore described with reference to Fig 14, in respect of versions employing a single distal housing 32.

S

As hereinbefore mentioned, versions of bougie jQ, may be made which are connected by wire means to an external power supply, image processing means and monitor means.

Accordingly, in these versions, wireless transmitter module 34, and battery 36, are omitted.

In an alternative version of the first preferred embodiment, not separately illustrated, a first distal housing 50, is located in introducer portion 12, of bougie jQ, and provides housing means for at least one imaging means 28, and at least one light source means 30. A second housing 52, provides housing means for battery means 34, together with the support circuitry and is located proximal to first distal housing 50, but in dilator portion 16, rather than on proximal portion 20. When second housing 52, is located in dilator portion 16, and depending upon the diameter thereof, there may be significant additional space available to accommodate a larger power reserve. Space available in dilator portion 16, may also be used to accommodate additional imaging means 28, and illuminating means.

Furthermore, if a plurality of imaging means 28, and light source means 30, is required to be provided, a plurality of electronics modules 40, may be deployed, for instance a first module 40, in introducer portion 12, and a second module 40, dilator portion 16. Such additional imaging means and illumination means may be used to provide means for close mural inspection.

Referring now to FIg 15, which includes a bougie similar to the bougie of Fig. 2, made of substantially soft materials and having a first distal housing 50, and a second proximal housing 52, connected by wires 54; 56, wired connection to an external power supply 62, is illustrated. A first suitable connector 58, is provided at second proximal housing 52, and a second suitable connector 60, is provided at power supply means 62, conveniently integrated with image processing means and monitor 48; no wireless receiver is required.

Conducting connecting means, in the form of wires within a lead 64, provided with suitable plug means (not numbered separately), extend from connector 58, at second proximal housing 52, to connector 60, at image processing means and monitor 48, and power supply means 62. Lead 64, conveys power from external power supply means 62, to the components including imaging means 28, and light source means 30, within first distal housing 50, and is controlled by switch means 38, within second proximal housing 52.

Lead 64, also conveys output from imaging means 28, to image processing means and monitor 48. Power supply means 62, may be mains-derived using transformer means or it may comprise an external battery.

It is possible to construct versions of the instant bougie j, having very narrow diameters, even in dilator portion 16, so that it may be deployed in narrow or small organs and cavities, for instance in urology, paediatric practice or in small animal veterinary practice. For instance, a CMOS chip camera, LED device, suitable battery, RF wireless transmitting module and may be accommodated in a suitable single distal housing 32, or first distal housing 50, of little more than 3 mm maximum diameter and may be made in any rational length, certainly in excess of 500 mm, if so required. Although these structural features constitute considerable advantages of the present invention, they do not lend themselves to drawings which are scalar and easily interpreted and it is to be understood that it has been necessary to alter proportions in order to illustrate the features of the invention clearly in the Figures.

In a generalised example of use of bougie jQ, in an anaesthetised or sedated patient, the instant bougie 10, will be outlined with reference to a wireless version having a single distal housing 32, such as is illustrated in FIg 14. In this example, bougie jQ, is made in silicone rubber and is presented in a sterile inner package. Bougie jQ, is unpacked into a sterile field according to standard protocols. An assistant, outside the sterile field, switches on wireless receiver 46, and monitor 48, both of which are supplied with a suitable power source 62.

When ready, the operator, wearing sterile gloves, fits bougie iQ over a suitable introducer 66, and operates switch 38, by pressing at point 44, on distal introducer portion 12, thereby switching on power from battery 36, to the components within electronics module 40, most notably to imaging means 28, light source means 30, and wireless transmitter module 34.

Introducer portion 12, of bougie 10, suitably lubricated, is then introduced into the body cavity, organ or vessel where a stricture or blockage is present and is advanced to the target stricture or blockage it is intended to treat. When the target stricture or blockage is reached -which will be directly observed by the operator -bougie j9, is advanced carefully into the lesion, still under continuous direct vision, until either dilation by bougie j, achieves passage, or a clinical decision not to proceed, is taken. The risk of rupture or the vessel or cavity walls associated with prior art blind-operated bougies is substantially removed by virtue of the illuminating and imaging features of instant bougie j.Q, and the risk and incidence of mural damage, which is common with prior art bougies, is greatly reduced.

Hollow versions of bougie j,Q, may be so constructed and adapted as to function well with many types of introducer, ranging from simple plastic rod types, through types which are mutually threaded with housings 32, 50, as illustrated in Fig. 8, at 68. Bougie j.Q, may also be used with the extendable and steerable portion of suitable steering means (not separately illustrated), of the general type disclosed inter alie in US5,607,435 to Sachdeva, modified as may be required. However, as hereinbefore indicated with respect to Fig 6a, solid versions of bougie jQ, may be integrated with introducer means at manufacture, for example by over moulding.

Referring to Figs 19 -21 there is illustrated, in diagrammatic form, a second preferred embodiment in which bougie 110, has a distal introducer portion 112, an elongate body portion 118, and a proximal portion 120, substantially as hereinbefore described with respect to the first preferred embodiment. In this embodiment, dilator portion 116, incorporates an inflatable circumferential balloon 170, having an inflation channel 172, within the body of bougie jiQ, whereby the diameter of dilator portion 116, may be varied by inflating and deflating balloon 170, during use according the prevailing surgical need.

This may be accomplished by injecting air or fluid by connecting a source thereof at connector means 174, through valve 176.

All other features and versions of the second preferred embodiment are substantially similar to those described in relation to the first preferred embodiment In all versions of both embodiments of 10, 110, described herein the bougie of the present invention may be constructed sufficiently inexpensively such that, where appropriate, it may be used and then disposed of, thereby obviating the risk of infection reported as associated with attempts to re-sterilise tubular instruments.

Although two preferred embodiments of the present invention have been described in the foregoing detailed description, it is to be understood that the invention is not limited to those embodiments disclosed herein but is capable of numerous rearrangements, modifications and substitutions without departing from the scope of the invention as set forth and defined by the following claims:-

Claims

Claims What we claim is:- 1. A bougie for dilating strictures and stenoses in humans and animals comprising: a distal introducer portion; a dilator portion proximal to said introducer portion; an elongate body proximal to said dilator portion; a proximal portion at least one imaging means; at least one light source means; a power supply; supporting electronic circuitry; and; external imaging equipment including monitoring means;
2. The bougie of Claim 1, wherein said dilator portion is continuous with said distal introducer portion and said elongate body portion;
3. The bouie of Claims I and 2, wherein said dilator portion has a forward taper;
4. The bouie of Claims 1 -3, wherein said dilator portion has a ptb*fttil taper;
5. The bougie of Claim I, wherein said dilator portion comprises inflatable balloon means;
6. The bougie of Claims 1 -5, wherein is provided a wireless transmitting module;
7. The bougie of Claims 1 -6, wherein said power supply is in the form of a battery;
8. The device of Claim 7, wherein said battery is of the zinc-air type;
9. The bougie of Claims 1 -7, wherein said power supply is external to said bougie;
10. The bougie of Claim 9, wherein connection to said power supply is by connecting wire means;
11. The bougie of any preceding Claim, wherein connection to said external imaging equipment including monitoring means is by wireless means;
12. The bougie of Claims 1 -10, wherein connection to said external imaging equipment including monitoring means is by connecting wire means;
13. The bougie of any preceding Claim, wherein is provided a hollow lumen open only at a second end;
14. The bougie of Claims I -12, wherein a lumen is absent;
15. The bouie of Claims 1 -12, and 14, wherein said bougie is integrated with introducer means at manufacture;
16. The bougie of Claims 1 -13, wherein said bougie is adapted for use with extendable mechanical steering means;
17. The bougie of any preceding Claim, wherein a portion of its length is adapted by the provision of a bellows or concertina construction;
18. The bougie of Claim 1, wherein the at least one imaging device is a CMOS camera chip;
19. The bougie of Claim 1, wherein the at least one imaging device is a CCD device;
20. The bougie of Claim 1, wherein the at least one imaging device is an optical device;
21. The bougie of Claim 1, wherein the at least one imaging device operates in the visible spectrum;
22. The bougie of Claim 1, wherein the at least one light source means is at least one light emitting diode emitting white light;
23. The bougie of Claim 1, wherein the at least one light source means is at least one light emitting diode emitting monochromatic light;
24. The bougie of Claim 1, wherein is provided a single distal housing comprising an electronics module, constituting housing means for said at least one imaging device, said at least one light source, said power supply, wireless transmitting means, and switch means and said supporting circuitry means;
25. The bougie of Claim 1, wherein is provided a first distal housing constituting housing means for said at least one imaging device and said at least one light source and wherein is provided a second proximal housing constituting housing means for any of said components not housed in said first distal housing;
26. The bougie of Claims 24 and 25, wherein any of said single distal housing, said first distal housing or said second proximal housing is made from metals;
27. The bougie of Claims 24 and 25, wherein any of said single distal housing, said first distal housing or said second proximal housing is made from plastics;
28. The device of Claims 24 -27, wherein either of said single distal housing and said first distal housing is provided with threaded adaptation means for the threaded receival of a mutually threaded mechanical introducer;
29. The device of Claim 1, wherein the at least one light source is provided with local reflecting chamber means by adaptation of said single distal housing or of said first distal housing;
30. The device of any preceding Claim, wherein said bougie is made from plastics or rubber derivatives;
31. The device of Claims 1 -29, wherein said bougie is made from metals;
32. The device of Claims 1 -29, wherein said bougie is made from composite materials including combinations of metals, plastics, rubber derivatives and carbon fibre;
33. The device of any preceding Claim wherein, said bougie is capable of being steritised;
34. The bougie of any preceding claim wherein said bougie is so constructed that it may economically be used once and then disposed of with the intent of eliminating the risks of cross infection associated with attempts to re-stenlise tubular instruments which have been introduced into mammalian bodies.