GB2452480A - Surgical device having illuminating and imaging means - Google Patents

SURGICAL DEVICE

Field

The invention is in the field of surgical and medical imaging.

Background To The Invention

There are many situations in surgery and medicine where it is required to see and otherwise investigate anatomical structures or lesions affecting such structures which are not situated on the external surface of the body. Although conventional endoscopes may be used in a large proportion of cases, they are relatively cumbersome, involve considerable capital investment and are notoriously difficult to re-sterilise, even when disinfection protocols and sterilization guidelines are followed which is not always the case (Rutala & Weber, Infection Control and Hospital Epidemiology, Volume 28(2007), pages 146 -155). There is thus a significant unmet clinical need to overcome or bypass the risks of cross-infection associated with conventional endoscopes, particularly in the present clinical environment where infective agents such as variant CJD, M.R.S.A. and c. difficile have become a very real threat in everyday clinical practice.

In addition, all current endoscopes and other imaging devices distance the physician or surgeon from the organ or tissue of a lesion in a manner which denies a very important tenet of practice, namely the feel of the organ or tissue. Whilst there are many occasions when an absence of tactility may be acceptable it is, nevertheless, unfortunate in other situations. Thus there remains a further significant unmet clinical need to provide a versatile device for imaging purposes in human and veterinary medicine which in many situations would allow the re-establishment of the tactile connection between the user and the patient.

I

Prior Art

Endoscopes in many forms have been progressively developed since the mid 1 9th Century with illuminating types being first seen in the early twentieth century. Fibre-optic based endoscopy emerged in the 1950s following the work of Hirschowilz and also Hopkins. Endoscopic surgery, begun in the nineteen seventies, developed rapidly and by the nineteen nineties was well established in gynaecology, gastroenterology and several other specialities. Latterly, wireless capsule endoscopy has emerged, the use of which is now quite widespread due to certain advantages over conventional endoscopy. None of these developments disclose means for achieving tactility synchronous with the imaging process and all current endoscopes are intended for serial use.

Outline Of The Present Invention According to a first aspect of the present invention there is provided a surgical device comprising a sheath together with illuminating and imaging means for use in the investigation of cavities, hollow organs and vessels in human and veterinary medicine. According to the version to be made and the intended application, the sheath of the device may be made by dip moulding, mandrel moulding, extrusion, welding or other well known processes for producing hollow shapes in plastic and rubber derivatives.

The sheath of the instant device may be made in latex, although allergy to latex is known and it may, therefore, be preferable to manufacture the device in other rubber derivatives and substitutes or plastics, for example and non-exclusively, silicone rubber, polyurethane, styrene-ethylene-butylene compounds or in any other suitable material. All the above proposed matenals, when used at the thicknesses described, can provide good tactility when used over a human digit.

Sheath portions of the instant device are made preferably with a general wall thickness which may vary in thin-walled versions from 0.01 mm to 0.1 mm or more and in thick-walled versions to in excess of 2 mm and may have a shape which can vary from a parallel-sided cylindrical shape to a cone shape to a full anatomical representation of a human first or second digit or they may be made as a full glove shape. Appropriate versions of the instant device may be used over a sterile glove but other versions may be incorporated into a partial or full-hand sterile glove and, in these versions, steering may be achieved by using a digit or digits. In other versions the device may be guided with a simple introducer, which may or may not be threadedly connected to portions of the device, or it may be introduced and steered with a more complex, dedicated, extendable steering device.

Hollow lumen portions of the instant sheath in thin-walled versions will tend to collapse but have the advantage that they may be packed readily into a wide variety of configurations. Hollow lumen portions of thick-walled versions of the instant sheath will not generally tend to collapse and will usually be stronger and more robust, however, they may be less easily packed in a compact manner.

According to a second aspect of the device 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 chip advantageously, though not necessarily, a small example of the CMOS type or a CCD device and in certain versions optical devices may be appropriate. In addition, in investigations which involve the vascular system and in cancer the provision of an infra-red camera chip may sometimes be preferable.

The light source and camera, located distally within the sheath may be powered by a local battery source either located distally or proximally within the device. 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 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 are advantageously mounted in the distal portion of the device, although in multiple digit versions of the device it may be advantageous to mount the camera on a first digit sheath portion and the light source on a second digit sheath portion. Alternatively, if a plurality of light sources and imaging devices is provided, mounting means for a first light source and a first camera may be provided on a first digit sheath and mounting means for a second light source and a second camera may be provided on a second digit sheath. Suitable battery means for this arrangement, together with appropriate support circuitry, may be located proximally.

Image signal decoding and 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 an RE transmitting module and supporting circuitry. This may include image encoding and compression means where appropriate. The housing may be accommodated and attached to the distal portion of the instant sheath, normally within a tailored distal lumen portion by adhesive means which may be a discrete adhesive or may involve a heat-sealing or heat shrinking process where the thermal and mechanical properties of the selected material from which the sheath is made are employed.

Alternatively, the distal portion of the sheath may be adapted to receive and retain the housing means compressively, for instance by a suitable forming, tapering or narrowing of the sheath, in a manner which allows, where appropriate, for the housing to be assembled to the sheath at the point of use.

According to a third aspect of a device according to the present invention, wipe means in the form of a wipe for cleaning the at least one imaging device lens or the at least one light source may advantageously be incorporated in at least one position in versions of the device constructed for use deployed on multiple digits.

According to a fourth aspect of the device according to the present invention, there is provided a hollow sheath having a primary lumen open at one end only, and adapted for the receival of introducer means or a human digit, and at least one through-lumen open at both ends and co-linear with the primary lumen and through which may optionally be deployed any desired axially oriented instrument such as, non-exclusively, suction, imgating or hypodermic means or a biopsy device.

According to a fifth aspect of the device according to the present invention, the instrument may be constructed sufficiently inexpensively such that it may be used then disposed of thereby eliminating any risk of cross infection which has been associated with re-stenlisation of prior art tubular instruments which have been introduced into mammalian bodies.

Objects Of The Invention Accordingly it is an object of the present invention to provide a surgical device comprising a sheath provided with at least one imaging means and at least one light source means for illumination and imaging of body cavities, hollow organs and vessels during the practice of human and veterinary medicine, the device generally being flexible and capable of being rendered sterile for use in humans; It is a further object of the present invention to provide a device comprising at least one sheath with a camera and light source which, 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 at least one sheath with a camera and light source which, during use, may be mounted upon and deployed by means of a human digit or a plurality of digits thereby providing tactility during the illumination and imaging process; It is a further object of the present invention to provide a device incorporating cleaning means in the form of a wipe or other cleaning surface for cleaning the at least one imaging device lens or the at least one light source or both and which may be advantageously incorporated in at least one position in versions of the device constructed for use deployed on a plurality of digits.

It is yet a further object of the present invention to provide a device comprising a sheath having a primary lumen open at a first end only, adapted for the receival of introducer means, and also to provide at least one through-lumen open at both a first end and a second end and adapted so as to be substantially co-linear with the primary lumen and through which through-lumen may optionally be deployed any desired axially oriented instrument, by way of non-limiting example, suction, irrigating or hypodermic means or a biopsy cutting device.

It is a further object of the present invention to provide a device comprising a sheath with at least one camera and at least one light source 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 re-useable imaging and illuminating instruments of the prior art.

BRIEF DESCRIPTION OF THE DRAWINGS

Further preferred features and advantages of the present invention will appear from the following detailed description of some embodiments illustrated with reference to the accompanying drawings in which: Fig. 1, is a schematic lateral view of a surgical device comprising a sheath with imaging and illumination means according to a first preferred embodiment of the present invention and having a substantially cylindrical form; Fig. 2, is a schematic lateral view of the device according to a first preferred embodiment of the present invention having a substantially extended conical form; Fig. 3, is a diagrammatic longitudinal interrupted sectional view of the device comprising a sheath with imaging and illumination means according to a first preferred embodiment of the present invention showing connecting wire means arranged intramurally; Fig. 4, is a diagrammatic longitudinal interrupted sectional view of the device according to a first preferred embodiment of the present invention showing connecting wire means arranged extramurally on the outer aspect; Fig. 5, is a diagrammatic longitudinal interrupted sectional view of the device according to a first preferred embodiment of the present invention showing connecting wire means arranged extramurally on the inner aspect; Fig 5a is a diagrammatic enlarged partial interrupted longitudinal sectional view of the device comprising a sheath with imaging and illumination means according to a first preferred embodiment of the present invention showing details of distal housing means and components housed therein and proximal housing means and components housed therein; Fig 5b is a diagrammatic enlarged partial longitudinal sectional view of the distal portion of a sheath with imaging and illumination means according to a first preferred embodiment of the present invention showing threaded means for a threaded introducer and threaded receival means in a distal housing; Fig. 6a, is a diagrammatic cross-section of a sheath according to the present invention having thin wall thickness such that the lumen is not self-maintaining showing the notional maintained' condition with a broken line and the collapsed condition with a solid line; Fig. 6b, is a diagrammatic cross-section of a sheath according to the present invention having relatively large wall thickness such that the lumen is self-maintaining; Fig. 7, is a schematic lateral view of a sheath with imaging and illumination means and wireless capability according to a first preferred embodiment of the present invention and having a substantially cylindrical form; Fig. 8, is a diagrammatic longitudinal sectional view of the device comprising a sheath with imaging and illumination means and wireless capability according to a first preferred embodiment of the present invention showing a distal housing and components but with numbers for internal components omitted for clarity; Fig. 9, is a diagrammatic longitudinal sectional view of the device comprising a sheath with imaging and illumination means and wireless capability according to a first preferred embodiment of the present invention indicating introducer means and showing a distal housing and components but with numbers for internal components omitted for clarity; Fig. 9a, is an enlarged diagrammatic partial longitudinal sectional view of a distal portion of a sheath showing a distal housing accommodating lens means, imaging means, illumination means, battery means and radio frequency (RF) transmitting means and threaded receival means together with threaded introducer means; Fig. 10, is a diagrammatic lateral view of the device comprising a sheath with imaging and illumination means and wireless capability wherein a substantial portion of the sheath has an accordion or bellows structure to facilitate deployment within body cavities, hollow organs and vessels which have small radii; Fig. 11, is a diagrammatic longitudinal sectional view of a sheath with imaging and illumination means and wireless capability indicating narrow introducer means within the accordion structure of the sheath. A distal housing and components is also shown but with numbers for internal components omitted for clarity; Fig. 12, shows the sheath and introducer of Fig. 11 with the introducer pushed distally whilst the proximal portion of the sheath has been restrained; Fig. 12a, indicates the capacity of the sheath and introducer of Fig. 11 to accommodate tight radii; Fig. 13a, is a longitudinal view of a version of the device compnsing a sheath according to the first preferred embodiment adapted for connection by wire means to an external power source, image processing means and monitor means; Fig. 13b, is a is a longitudinal interrupted sectional view of a version of the device comprising a sheath according to the first preferred embodiment adapted for connection by wire means to an external power source, image processing means and monitor means. Distal and proximal housing are indicated but numbers relating to their internal components have been omitted to maintain clarity; Fig. 13c, is a block diagram of image processing means and image monitoring means to which the instant device is connected by wires; Fig. 13d, is a longitudinal view of a version of a sheath according to the first preferred embodiment adapted for use with internal battery power means and connection by wireless means to mage processing means and monitor means. A distal housing is shown but numbers relating to the internal components have been omitted for clarity; Fig. I 3e, is a block diagram of image processing means and image monitoring means to which the instant device is connected in a wireless manner; Fig. 14a, is a diagrammatic palmar view of the device comprising a sheath with imaging and illumination means and a wrist strap according to a second preferred embodiment of the present invention adapted for connection by wire means to an external power source, image processing means and monitor means and further adapted for deployment over a single human digit, in this case indicating the index finger; Fig. 14b, is a diagrammatic palmar view of the device cornpnsing a sheath according to a second preferred embodiment of the present invention with imaging and illumination means, wireless capability and adapted for deployment over the index finger; Fig. 14c, is a further view of the sheath of Fig 14a, shown connected by wires to an external power source, image processing means and monitor means; Figs. 15 -18, are, respectively, a diagrammatic proximal cross-sectional view, and palmar, medial, partial medial cross-section, and dorsal views of the device comprising a dual sheath with imaging and illumination means and wireless capability according to a third preferred embodiment of the present invention for the index finger and middle finger of a left hand in which imaging means is provided in one sheath and illumination means is provided in a second sheath; Fig. 18a, is a palmar view of the device comprising a dual sheath with imaging and illumination means and wireless capability according to a third preferred embodiment of the present invention for the index finger and thumb of a left hand in which imaging and illuminating means are deployed on a first, index finger, sheath and wipe means are deployed on a second, thumb, sheath; Fig. 19, is a diagrammatic palmar view of the device comprising a multiple sheath with imaging and illumination means and wireless capability integrated into a left hand glove arrangement according to a fourth preferred embodiment of the present invention which additionally provides lens and light cleaning or wiping capability; Fig. 20, is a schematic lateral view of the device comprising a sheath with imaging and illumination means according to a fifth preferred embodiment of the present invention and having a first lumen open only a first end and a second through-lumen open at each of a first end and a second end; Fig. 21, is a diagrammatic longitudinal sectional view of the device comprising a sheath with imaging and illumination means according to a fifth preferred embodiment of the present invention and having a first lumen open only a first end adapted to receive introducer means to facilitate deployment and a second through-lumen open at each of a first end and a second end adapted to receive instrument means, in the case illustrated, a biopsy cutter, shown on a stepped centre-line in non-deployed-retracted-closed, deployed- closed and deployed-open positions; Fig. 22, is a diagrammatic cross-section of a sheath according to a fifth preferred embodiment of the present invention having two lumens formed with relatively large wall thickness such that the lumens are self-maintaining; Fig. 22a, is a diagrammatic cross- section of a variant of the two-lumen sheath of Fig 26, also where the bore is self-maintaining, and where a larger amount of material is disposed between the lumens; Fig. 23, is a diagrammatic cross-section of a two-lumen sheath according to a fifth preferred embodiment of the present invention having relatively thin wall thickness such that the two bores are not self-maintaining and are formed by means of an axial longitudinal welded seam in a single tube; Fig. 23a, shows the two lumen sheath of Fig 27, presented in a folded condition along its axial welded seam to facilitate deployment; Fig. 24a, shows an interrupted longitudinal view of an introducer for a sheath, including a two-lumen sheath according to the fifth preferred embodiment of the present invention, and comprising a small diameter inner threaded element and a considerably larger diameter outer non-threaded element; Fig. 24b, shows a proximal cross-sectional view of the introducer of Fig. 28a; Fig. 25, is a diagrammatic view of the device comprising a sheath with imaging and illumination means and wireless capability according to a first preferred embodiment of the present invention, presented folded; Fig. 25a, is a diagrammatic view of the device comprising a sheath with imaging and illumination means adapted for wired connection to external image processing and monitor means according to a first preferred embodiment of the present invention, presented folded; Fig. 26, is a diagrammatic view of the device comprising a sheath with imaging and illumination means and wireless capability according to a second preferred embodiment of the present invention presented with the sheath compression-folded axially giving a ruched appearance; Fig. 27, is a diagrammatic palmar view of the device comprising a dual sheath with imaging and illumination means and wireless capability according to a third preferred embodiment of the present invention for the index and middle digits of a left hand presented with the sheaths compression-folded axially giving a ruched appearance; Fig. 28, is a diagrammatic view of the device comprising a sheath with imaging and illumination means and wireless capability according to a first preferred embodiment of the present invention presented rolled on an axial mandrel; Fig. 28a, is a diagrammatic view of the device comprising a sheath with imaging and illumination means according to a first preferred embodiment of the present invention adapted for wired connection and presented rolled on an axial mandrel;

Detailed Description Of Some Preferred Embodiments

A surgical device ig, for the investigation of cavities, hollow organs and vessels, hereinafter referred to as device 10, is for use in human and veterinary medicine and is described with general reference to Figs I -28a. The device is generally intended to be flexible and to be presented and used sterile, however, it is recognised that in certain areas of veterinary practice, particularly in large animal practice, the device may not need to be stenlised before use.

In a first preferred embodiment of the present invention, device 10, comprises a sheath 12, 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), of the general type disclosed inter alia in US5,607,435 to Sachdeva, modified as may be required.

Sheath 12, may be made of latex, or it may be made of silicone rubber, polyurethane or of a styrene-ethylene-butylene compound or of any other suitable material which for most applications should be substantially flexible.

Sheath 12, may be manufactured by dip moulding, by thermal moulding processes or by extrusion or using a room-temperature vulcanising (RTV) process. Sheath 12, may be made in thin-walled versions which are made preferably with a wall thickness which may vary from 0.01 mm to 0.1 mm or more.

As indicated in Fig 6a, thin-walled versions of sheath 12, will not generally maintain their lumens if unsupported from within and require an introducer, mandrel or digit to maintain the lumen. Sheath 12, may also be made in thicker-walled versions having a wall thickness varying from the upper suggested limit of thin-walled versions to in excess of 2 mm. Thick walled versions, depending upon the selected thickness and the material selection, may maintain their bores even though unsupported. In some versions it may be advantageous to provide thicker walls locally to support ancillary structures or to perform a protective function. The observations concerning wall thicknesses apply not only to sheath 12, of the first preferred embodiment but also to the sheaths of all subsequently disclosed embodiments.

As may be seen in Fig. 1, conveniently, sheath 12, has a substantially parallel-sided cylindrical shape or it may be in the form of art extended conical shape (Fig. 2) and in both cases terminates proximally in a proximal end portion 16. In this embodiment, device 10, is not handed and, as indicated at 18, in Fig 3, is substantially hollow and open only at the first proximal end 16.

In the following descriptions, internal components and housing means therefore may best be referenced to Fig 5a and Fig 9a. At least one imaging device 20, preferably a small CMOS camera chip, is provided near the second end of sheath 12, hereinafter referred to as distal tip 22, together with at least one light source 24, preferably but not necessarily a LED light source which may emit white light or may be monochromatic, for instance producing emissions in the infra red spectrum. Each of the at least one imaging device 20, and at least one light source 24, may be mounted at any convenient position near distal tip 22, in suitable first housing means in the form of distal housing 34a, 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 housing 34a, is to close off sheath 12, in the region of its distal tip 22. A lens 26, is provided over the active face of imaging device 20. It should be noted that other types of imaging device operating outside the visible light spectrum may be used in the present invention, for instance infra-red camera chips which may have particular applications in imaging blood vessels or tumours, or an appropriate optical device may be selected. Charge coupled devices (CCD) or optical devices are also possible choices in any of the preferred embodiments described herein.

Distal housing 34a, may be accommodated within and attached to distal portion 22, of sheath 12, by adhesive means which may be a discrete adhesive or may involve a heat-sealing or heat shrinking process where the thermal and mechanical properties of the selected material from which sheath 12, is made are employed.

It is possible to construct versions of the instant device of very narrow diameter so that it may be deployed in narrow or small organs and cavities, for instance in paediatnc medical practice or in small animal veterinary practice. For instance, a CMOS chip camera, LED device, suitable battery, RF wireless transmitting module and suitable housing may be accommodated in an instant sheath 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.

A wireless transmitter module 28, such as a Bluetooth module, and a power source comprising, in the version illustrated in Fig 5a, a battery 30 (which may, as in the example illustrated, comprise a plurality of cells), together with supporting electronic circuitry (not separately illustrated) and a press-for-on switch 32 (or other suitable switch), are located in second housing means in the form of proximal housing 34b, near proximal end 16, of sheath 12. Proxima l housing 34b, is substantially similar in construction and materials, though not necessarily shape, to distal housing 34a. The components housed in distal housing 34a, namely light source 24, and imaging device 20, are linked to those in proximal housing 34b, by suitable connecting wires 36; 38. Supporting electronic circuitry may include image encoding means where appropriate. Proximal housing 34b, may be attached to proximal portion 16, of sheath 12, by adhesive means or it may be incorporated into moulded versions of sheath 12.

It is to be understood that the portion of distal housing 34a, housing at least one light source 24, may be adapted to provide local reflective chamber means for 24, including versions comprising a plurality of light sources (such as an array) and all figures so labelled are drawn to indicate this intention. This applies not only to all versions of the first preferred embodiment but also to all versions of all other embodiments of the present invention hereinafter disclosed.

As may be seen in Figs 3 -5, connecting wires 36; 38, may be incorporated intramurally into sheath 12, of device jQ, or be attached adhesively with adhesive means or any other suitable means, extramurally, to 12, on either the inner or outer aspect. Alternatively, wires 36; 38, may be led unattached, running for instance within sheath 12, to housing 34b, which may, optionally, itself be unattached to sheath 12, as may be seen by brief reference to Figs 25a and 28a.

Battery 30, may be any convenient small non-rechargeable type, however a bank of two or three small zinc-air cells of the type widely used in small portable devices such as hearing aids are preferred for internally powered versions. The use of such a battery is possible because the applications in which the instant device is likely to be used are generally not very protracted procedures and device 10, is intended and 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.

As may be seen by brief reference to Fig 13e, a wireless receiver 42, such as a Bluetooth enabled receiver, connected to a suitable monitor 44, having image signal decoding means, is located outside the body in a position where, in use, monitor 44, may be readily observed by the operator.

In Figs 7 -9a, there is shown a variant of the first preferred embodiment of device 10. In this variant, all the electronic and electric components comprising wireless transmitter module 28, battery 30, supporting electronic circuitry and press-for-on switch 32, may be located at a position near distal tip 22, conveniently proximal to light source 24, and imaging device 20, all assembled as a single module accommodated within a single distal housing 34. Connection between these components may be achieved using a small PCB means or other convenient direct contact means (not separately illustrated), connecting wires 36; 38, being omitted in this variant. Distal housing 34, is made as hereinbefore described with respect to distal and proximal housings 34a; 34b, and closes off sheath 12, near distal tip 22, in a manner substantially similar to distal housing 34a.

Single distal housing 34, is also used in the version of the first preferred embodiment shown in Figs 10-12a. Sheath 12, may optionally have an accordion (alternatively described as a bellows or concertina) construction 14, along at least part of its length to facilitate negotiation of tight radii during use. It should be noted, however, that accordion construction may represent a more complex manufacturing challenge than, say, dip-moulded thin-walled plastics and, in many applications, the use of the latter may be preferred.

In versions of the first preferred embodiment using single distal housing 34 (and its analogues 134; 234; 334; 434, in versions of other preferred embodiments hereinafter disclosed) there exists the option, in addition to attaching housing 34, to distal portion 22, of sheath 12, by adhesive means, heat-sealing means or heat shrinking means, of adapting distal portion 22, to receive and retain distal housing 34, compressively, for instance by a suitable forming, tapering or narrowing of the sheath. This option provides for the possibility, where appropriate, for housing 34, to be assembled to sheath 12, at the point of use.

In another variant of the same first preferred embodiment, an external power source is used to power device j, battery 30, being omitted. As may be seen by brief reference to Figs 13a -13c, in this version, conducting connecting means, in the form of wires 46; 48, extend from proximal housing 34b, to take output from imaging device 20, to image processing means and monitor 44. In this version, wireless transmitter module 28, and wireless receiver 42 (indicated in Fig 13e), are not required. Power supply 43; 143, may be mains derived using transformer means or it may comprise an external battery. It is to be understood that in this and in all other embodiments hereinafter described, image signal processing means may be located elsewhere at any convenient place, which may include at the camera chip 20, itself or elsewhere in distal housing 34a, or in proximal housing 34b.

In a generalised example of use in a human patient, anaesthetised or sedated if appropriate, instant device 10, is presented to an operator within a sterile field in a sterile inner package and is unpacked into the sterile field according to standard protocols. An assistant, outside the sterile field, switches on wireless receiver 42, and monitor 44, both of which are supplied with a suitable external power source 43.

The operator fits device 10, over a suitable introducer 62a, and operates switch 32, on housing 34, or 34b, according to the version of sheath 12, being used, thereby switching on power from battery 30, to imaging device 20, light source 24, and wireless transmitter module 28. Device 10, is then introduced into the body cavity, organ or vessel to be investigated and is advanced to the target area. When the target is reached it may be imaged or otherwise investigated. Using a small bank of two or three zinc-air coin-type cells, device iQ following switch-on, will generally provide sufficient power 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.

As may be seen by particular reference to Figs 14a -c, a second preferred embodiment of the present invention, device jj, comprises a sheath 112, for a single digit of the human hand, preferably, but not necessarily, the index finger 114.

Sheath 112, may be made from any of the materials suggested with respect to the first preferred embodiment and may be made by most of the same processes with the general intent that it should be flexible. Sheath 112, is made in any suitable wall thickness, as hereinbefore descnbed and advantageously has a shape which corresponds substantially to a generalised anatomical representation of a human digit upon which it is intended to be deployed, though it is to be understood that sheath 112, may also be in any shape which will comfortably fit over a human digit.

Sheath 112, conveniently has a substantially circular cross section and terminates proximally in proximal portion 116. The length and maximum diameter of sheath 112, may be varied to accommodate differing linger sizes, however, advantageously for managing supplies of device jjQ, the number of sizes of sheath 112, supplied commercially would be limited, perhaps to three (small, medium and large) or five (extra small to extra large) based upon readily available anthropometnc data.

As indicated at 118, in Fig 14a, device 110, is substantially hollow and at least one imaging device 120, (not visible in Fig 14) preferably a CMOS camera chip, having a lens 126, is provided near the distal tip 122, of sheath 112, together with at least one light source 124, preferably but not necessarily a LED light source. Each of the at least one imaging device 120, and at least one light source 124, may be mounted at any convenient position near distal tip 122, in distal housing 134a (the position of which is indicated but not seen directly in Fig 14a). In a manner analogous to the first preferred embodiment, suitable connecting wires 136; 138 (not seen and which may be intramural or extramural), extend proximally between camera chip 120, and light source 124, within distal housing 134a, to proximal housing 134b, (not seen directly but indicated in Fig 14a). Proximal housing 1Mb, is provided with switch 132, and located at proximal portion 116. Within proximal housing 134b, (and thus not seen in Fig 14a) are housed wireless transmitter module 128, typically zinc air battery means 130, and supporting circuitry means, including image encoding means, as appropriate and as previously herein disclosed with respect to the first preferred embodiment. The use of small zinc air batteries is possible for the same reasons as those given in respect of the first preferred embodiment and device 110, is intended and constructed for single use and thereafter to be discarded.

The wireless arrangement whereby a wireless receiver 142, such as a BluetoothTh enabled receiver is connected to suitable image processing and decoding means and monitor 144, located outside the body in a position where, in use, monitor 144, may be readily observed by the operator, is substantially similar to that for a wireless version of the first preferred embodiment and this general arrangement may be referenced at Fig 13d and 13e.

Human distal phalanges have exceptional tactile responsiveness due to their profuse pattern of innervation, particularly on the palmar aspect. It is important to observe, in the execution of this second preferred embodiment of the present invention, that where possible, at least parts of the palmar aspect of the distal phalangeal portion of sheath 112, should be unencumbered by imaging or illumination means in order that the tactile feature of device 110, is optimised. It is for this reason that a preferred extreme distal disposition of housings 134a, and 134, is illustrated for all variants of the second preferred embodiment.

The second preferred embodiment is used in a manner substantially similar to the first preferred embodiment. Referencing, as an example, the variant instant device jj, illustrated in Fig 14a, a human or animal patient is anaesthetised or sedated as appropriate. Device jfl, is presented in a sterile inner package and is unpacked into a sterile field according to standard protocols. An assistant, outside the sterile field switches on wireless receiver 142, and monitor 144, both of which are supplied with a suitable external power source. When ready, the operator, wearing sterile gloves if in human medical practice, dons sheath 112, of device 110, as indicated by arrow A' in Fig 14a, using a suitable lubricant, if required. Once donned, device jj, may be retained by an optional wrist strap 140, intended to counteract any drag effect which might be occasioned by the mass of housing 134b, and its contents which, though not great, might otherwise represent an inconvenience to a user. Wrist strap 140, is secured in place, by way of example only, with a hook and loop patch arrangement indicated at 141, in Fig 14a. Switch 132, is subsequently operated, thereby delivering power from battery 130, to imaging device 120, light source 124, and wireless transmitter module 128. Battery type, life and performance for device 110, is as hereinbefore described with respect to the first preferred embodiment.

The selected index finger of the operator, with device 110, in place arid suitably lubricated, is introduced into the vessel or cavity which is to be investigated and gently advanced towards the target under continuous, illuminated, direct vision.

When the target is reached it may be imaged and palpated or otherwise investigated, including by touch to the extent that this is indicated, thereby conveying to the operator and the care team more information than is possible with any conventional imaging device used alone. The use of device 110, which intrinsically provides good tactile input to the operator, provides excellent means for ensuring that mural trauma or rupture is much less likely than with rigid and even many types of flexible prior art imaging devices.

In a variant of the second preferred embodiment, illustrated in Fig 14b, housing 134, is located near distal tip 122. Although the contents of housing 134, are unseen, in Fig 14b, they comprise wireless transmitter module 128, battery 130, press-for-on switch 132, light source 124, and imaging device 120, and supporting electronic circuitry as hereinbefore described, all of which may be connected together by small PCB means or other convenient direct contact means. Connecting wires 136; 138, and wrist strap 140, are unnecessary in this version and are omitted.

In another variant of the second preferred embodiment, seen in Fig. 14c, an external power source is used to power device jjQ, battery 130, being omitted. Insofar as signal transfer, image processing, monitoring and power supply are concerned, the external arrangements are substantially similar to those described hereinbefore in respect of externally powered versions of the first preferred embodiment and may be referenced at Fig 13b, and Fig 14c.

Conducting connecting means, in the form of wires 146; 148, extend from second housing 134b, to take output from imaging device 120, to image signal processing means and monitor 144. In this version neither a wireless transmitter module nor a wireless receiver is required and image signal processing means may be located at any convenient place. Power supply 143, is substantially similar to 43, described with respect to the first preferred embodiment. Distal housings 134; 134a, are analogues of distal housings 34; 34a, and close off sheath 112, in the region of its distal tip 122.

In a third preferred embodiment of the present invention, illustrated in Figs. 16 -18, device Q, comprises dual sheaths 212; 21 2a, preferably manufactured in one piece and advantageously also comprising a dorsal web element 213. Each of sheaths 212; 212a, is for a single digit of the human hand, preferably, but not necessarily, the index finger and middle finger. A wrist strap is desirable to secure web 213, around the wrist of the operator but is omitted from Figs. 16-18, for clarity.

Sheaths 212; 212a, may be made and supplied substantially as hereinbefore described with reference to the first and second preferred embodiments. Similarly, sheaths 212; 212a, are substantially hollow, however sheath 212, is provided with at least one imaging device 220, preferably as a CMOS camera chip, located in a first distal housing 234c, mounted at any convenient position near its distal tip 222, whereas sheath 212a, has at least one light source 224, preferably but not necessarily a LED light source provided in a second distal housing 234d, mounted at any convenient position near its distal tip 222a. A lens 226, is provided over the active face of imaging device 220. The provision of extending wires between first distal housing 234c, and second distal housing 234d, could make dual-sheath device 210, less flexible and perhaps more cumbersome. Since an important object of device Q, is to optimise the tactile feature for investigations where it is to be used, it is preferable to accommodate separate batteries 230a; 230b, and switches 232a; 232b, in each of 234c; 234d, respectively, leaving the remaining portions of sheaths 212; 212a, respectively, unencumbered. Distal housings 234c; 234d, are analogues of distal housings 34; 134 and 34a; 134a, and close off respective sheaths 212; 212a, in the regions of distal tips 222; 222a. As with the first and second preferred embodiments, device 210, is intended for single deployment and use. Battery type, life and performance for device 210, as well as details of supporting electronic circuitry, are as hereinbefore described with respect to the first and second preferred embodiments. as hereinbefore described The mode of use is also essentially similar to that of the second preferred embodiment except that, in this third preferred embodiment, there is independent control of the light source which enables light incidence and camera angle to be independently varied and controlled from the respective digits upon which they are deployed. This can be valuable when assessing suspicious lesions or any other feature of interest. The qualitative value of tactility may also be enhanced when a structure or lesion is palpated with the light-source-bearing-digit, synchronously with viewing from a camera position selected, optimised and maintained with the camera-bearing digit.

In a variant of this third preferred embodiment, illustrated in Fig 18a, sheath 212, for an index finger has mounted near its distal tip 222, a single distal housing 234, accommodating all the electronic and electric components comprising wireless transmitter module 228, battery 230, supporting electronic circuitry and press-for-on switch 232. The disposition and nature of distal housing 234, and its components are substantially as illustrated in Fig 9a, with respect to the first preferred embodiment and are not illustrated separately. Sheath 21 2a, is for the thumb and is provided with suitable wipe means in the form of a wipe 219, for cleaning lens 226, and light source 224, by apposition of the palmar surface of wipe 219, thereto.

In a fourth preferred embodiment of the present invention, illustrated in Fig 19, device 310, comprises triple sheaths 312; 312a, 312b, incorporated into and manufactured as part of a glove 350, each of sheaths 312; 312a, 312b, being for a single digit of the human hand, preferably, but not necessarily, the index finger, middle finger, and thumb, respectively. This embodiment may be particularly advantageously used in large animal veterinary practice though it is not exclusively for this purpose.

Sheaths 312; 31 2a, 31 2b, and glove 350, of device iQ may be made and supplied substantially as hereinbefore described. Index finger sheath 312, is provided with a first distal housing 334c, near its distal tip 322, accommodating at least one imaging device 320, wireless transmitting module 328, and battery 330a, together with supporting circuitry. It is desirable that at least a portion of the palmar aspect of index finger sheath 312, is unencumbered in order to allow the tactile feature offered by device 310, to realised and optimised. A lens 326, is provided over the active face of imaging device 320.

Sheath 312a, for the middle finger, is provided with a second distal housing 334d, near its distal tip 322a, accommodating at least one light source 324, preferably but not necessarily a LED light source and battery 330b. It will be appreciated that both first and second housings 334c; 334d, are very small, may be manoeuvred easily, and do not obtrude excessively within the field of operations. Distal housings 334c; 334d, are analogues of distal housings 234c; 234d, and close off respective sheaths 312; 312a, in the regions of distal tips 322; 322a.

Sheath 31 2b, for the thumb, is provided with wipe-cleaning means in the form of a pad or wipe 319, which may be apposed to lens 326, on sheath 212, for the purpose of maintaining optimal image quality during a procedure. Optionally and additionally, a second wipe or pad 319a, may be provided on the palmar aspect of a sheath 312c, for the fourth ray and, indeed although not illustrated separately, any rational part and portion of glove 350, may be surfaced with additional or alternative wipe means (not separately illustrated).

Large animals have large body cavities and these are often are accessed with the full hand (and sometimes the arm) of a veterinarian. With device 310, it is possible to close the hand of glove 350, during insertion such that lens 326, and light source 324, are substantially protected from contamination. This action also has the effect of preventing wipes 319; 319a or any other provided wipe surface from gross contamination before the target has been approached and wipe surfaces 319; 319a, may thereafter be usefully deployed, in a substantially uncontaminated manner, as the investigation progresses.

Details for a battery powered wireless transmitting variant and an externally powered hard-wired variant, as well as details of supporting electronic circuitry, are substantially as hereinbefore disclosed with respect to previous preferred embodiments and are not illustrated or described separately.

In a fifth preferred embodiment, illustrated in Figs 20 -24a, there is provided a flexible device 410, for the investigation of cavities, hollow organs and vessels, hereinafter referred to as device and which is for use in human and veterinary medicine. Device 4j.Q, may be seen with reference to Figs. 20-21, and comprises a sheath 412, having a first or primary lumen 458, open at a first end 460, and which has mounted near its distal tip 422, a single distal housing 434, accommodating electronic and electric components. Distal housing 434, is an analogue of distal housings 34; 34a and of 134; 134a, and closes off first lumen 458, of sheath 412, in the region of its second end constituted by distal tip 422.

The components housed within distal housing 434, comprise at least one imaging device 420, and at least one light source means 424, wireless transmitter module 428, battery 430, supporting electronic circuitry and switch 432, all generally according to any previously described embodiment. Numbers for these components have been omitted in Fig. 21, for clarity and the arrangement is substantially similar to that shown in Fig 9a, with respect to the first preferred embodiment.

First lumen 458, of sheath 412, is adapted for the receival of introducer means as shown in Fig 21, at 462. However, sheath 412, is further adapted by the provision of at least one through-lumen means 464, open at both a first end 466, and a second end 468. Through-lumen 464, is adapted so as to be co-linear with first lumen 458, and through it may be deployed any desired axially oriented instrument means from exemplary options including, non-exclusively suction means, imgating means, hypodermic means, biopsy cutter means, cautery means or foreign-object gripping means.

In a generalised example of use in a human patient, anaesthetised or sedated if appropriate, instant deviáe 412. is presented to an operator within a sterile field in a sterile inner package and is unpacked into the sterile field and prepared for use substantially as hereinbefore described with reference to previous embodiments.

However, in this fifth preferred embodiment, generally at the time of initial deployment, but possibly at a later time if a clinical need, not initially anticipated, arises, selected instrument means may be deployed via through-lumen 464.

Following completion of the task, the selected instrument means may be retrieved via through-lumen 464, either prior to the end of the overall procedure for which device 410, was selected or, subject to anatomical considerations and safe practice, selected instrument means may be retrieved at the same time as device 4j*, is removed.

By way of non-limiting example, Fig 21, shows device 410, with an introducer 462, in situ in primary lumen 458. Exemplary instrument means, in this case a biopsy cutter 470, is presented within through- lumen 464, retracted at a position just proximal to second end 468, of 464. By means of a stepped centre-line, biopsy cutter 470, is shown at 470a, in an extended position -closed, and at 470b, in an extended position -open. Depending upon the manufactured design selected for device 41.2' some of the options for which are shortly hereinafter disclosed, biopsy cutter 470, may be used to harvest a tissue sample and subsequently be retracted into through-lumen 464, all under direct illuminated vision. Thereafter, device 410, may be withdrawn from the subject, the tissue sample may be dispensed as appropriate and thereafter device 41Q. may be disposed of.

Turning to Figs 22-23a, there are shown several options for manufacturing the fifth preferred embodiment. Fig 22; shows a relatively thick-walled version which may be made by, for example only, by bonding a duality of independently extruded tubes.

The relatively thick-walled version of Fig 22a, is co-extruded and somewhat bulkier than that of Fig 22. Advantages of this approach are that resulting device 4j, may be made more robust, though this may ultimately be at the expense of reduced flexibility. Both thick-walled versions of Fig 22, and Fig 22a, may, however, be made for example by a suitable moulding process, with an accordion or bellows construction to overcome any flexibility issues raised by greater wall thickness.

Although as shown in Figs 22; 22a, both lumens are of the same size, this is not a necessary requirement. First lumen 458, is sized so as to be appropriate to accept the type of introducer it is required to use and also according to the size of distal housing 434, which may be secured in place, by way of example, using suitable adhesive means to achieve the open-at-first-end-only condition at 460. The size of distal housing 434, in this embodiment, as in all previous embodiments, is determined by several choices. These include the choice of camera which may be a CMOS chip, a CCD device, an infra red chip or even an optical device; the choice and number of battery cells and the type of RF wireless transmitting module.

Fig 23, shows a relatively thin-walled version which may be made by, for example by dip or mandrel moulding and subsequently establishing a central longitudinal axial seam 472, by, for example, heat or ultrasonic welding. Alternatively, this version may be formed entirely by welding together two substantially similar pieces of selected material or by any other suitable process for producing a two-lumen arrangement.

As shown in Fig 23a, seam 472, provides the advantageous possibility of longitudinally over-folding 4j, which may allow instrument means 470, to be introduced into what may otherwise be an unfeasibly small cavity or organ. By way of explanation, a version of device 4Q, may be presented as shown in Fig 23a. A suitable introducer 462, shown in Figs 24a, and 24b, comprises two concentric components, an inner component 462a, of considerably smaller diameter and conveniently of considerably greater length than an outer component 462b. At the commencement of a procedure, introducer 462, is deployed within first lumen 458, of sheath 412, following which the combination of introducer 462, and device 410, is deployed within the subject's narrow cavity or organ.

Once the target has been illuminated, identified and approached, outer larger diameter introducer component 462b, is withdrawn and the position of 4jQ, is maintained using inner component 462a. Because inner component 462a, is of much smaller diameter than outer component 462b, the removal of the latter provides the necessary space to allow exemplary instrument means 470, to be introduced and advanced to the target under direct vision. This is despite the fact that the cavity or organ is too small to accept, simultaneously, complete introducer 462, and sheath 412, with distal housing 434, and exemplary instrument means 470, without the risk of mural or other damage. Any tendency of exemplary instrument means 470, to wander out of alignment during advancement beyond second end 468, of through-lumen 464, of sheath 412, may be countered by locally thickening or otherwise reinforcing 468, for instance in an annular manner (not separately illustrated).

Inner component 462, and housing 434, may be further adapted by the provision of mutually threaded engagement means 474, seen best by reference to Fig 24a, or other suitable mutual engagement and locking means, in order to allow an operator to stab ilise device 410, at the target whilst, for instance, instrument means 470, is introduced through lumen 464. The provision of mutually threaded engagement between an introducer and a housing may be applied in many versions of the instant device and may be seen with reference to Fig 9a, at 74, in respect of housing 34, and introducer 62, of the first preferred embodiment and is also shown in Fig 5b. It is not always necessary to use two-component introducers, for example, introducer 62, of Fig 9a, is a single part introducer and of relatively large diameter. Nor is it necessary to use only large diameter introducers as may be seen by brief reference to Figs 10-12a, wherein introducer 62a, shown is of narrow diameter, relative to the lumen of sheath 12, but could also be of larger diameter according to choice of the operator. Introducers for the instant device should generally be flexible and may conveniently by made in suitable grades of polyethylene when of larger diameter or they may be made of flexible wire or rod when a small diameter is required.

All versions of the five embodiments of device, 10, 110, 210, 310, and 4j described herein may be constructed sufficiently inexpensively such that they may be deployed, used and then disposed of, thereby eliminating the risk of infection widely reported as associated with the restenlisation of long tubular conventional imaging or imaging and illumination devices. Many versions of the disclosed embodiments, particularly the second, third and fourth embodiments, also provide a tactile examination capability synchronous with imaging and illumination.

The different embodiments 10, 110, 210, 310, and 410, may have different optimal forms for presentation according to intended use. Thus, as shown in Fig 25, wireless versions of first preferred embodiment jQ, for use with an introducer, may advantageously be presented packed folded. First preferred embodiment j.g, may also be presented packed flat and straight in an axial orientation, substantially as may be seen by brief reference to Fig I or Fig 2, such that an introducer may readily be introduced into j.Q, as it is disgorged from suitable sterile inner packing means.

As shown in Fig 25a, versions of first preferred embodiment, for wired connection and for use with an introducer, may also be presented packed folded.

Although the second, third and fourth embodiments 110, 210, 310, may also be presented packed flat or folded (not shown) they may also be presented, for example, in an axially compressed, ruched, manner as indicated in respect of 110, at 152, in Fig 26, and in respect of 210 at 252; 252a, in Fig 27, in order that they may be donned by a plunging' action in the manner well known to surgeons donning sterile gloves preparatory to an operative procedure. This donning procedure often involves a scrubbed-in' assistant who carries out the unpacking in the sterile field and presents the device, suitably oriented, to the surgeon, veterinarian or other operator of the device.

A further alternative, shown in Figs 28, and 28a, is that wireless versions (and also versions where connecting wires 36; 38, 136; 138 and proximal housing 34b; 134b are not attached to sheath 12; 112) for the first and second preferred embodiments is that they may be rolled about a core which may be left in situ at packing or which may be removed prior to packing. Alternatively, these embodiments may be rolled proximally to distally, as may be achieved for example by using an axial mandrel during manufacture and indicated at 55, in respect of device 10, in Fig 28. Examples of device 10, packed in this way may be deployed from a doughnut' configuration 54; Ma, by unrolling on the mandrel which may be used to provide introducer means.

Alternatively, mandrel 55, may be removed at unpacking immediately prior to use to be replaced by other introducer means, including possibly a digit. This mode of packing and presentation is possible because there are no significant components attached or dose to proximal portions 16, 116. Optionally and desirably, however, when this method of presentation is adopted, proximal portions 16, 116, are provided with annular reinforcement means seen at 56, in respect of the first preferred embodiment 10, only in Figs 7-9. The purpose of annular reinforcement means 56, is to ease manufacture, donning and subsequently, doffing. This condition is not illustrated separately in respect of the second preferred embodiment.

Although five 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:-