DEVICE FOR USE IN HYSTEROSCOPY

Abstract

A hysteroscopy device with an image capturing structure located at a distal end of an elongated member and communicating video signals with a monitor. The elongated member and the image capturing structure being dimensioned for insertion into the patient's uterus through cervix.

Claims

1-23. (canceled)

24. A device for visualization of internal tissue of a patient's uterus, the device comprising a hand-held control unit, an elongated member, and an image capturing structure, the control unit being dimensioned to be held by a user's hand, the elongated member having a proximal end connected to or connectable to the hand-held control unit and a distal end holding the image capturing structure, where the image capturing structure is configured to communicate video signals representing still pictures or video with a monitor, where at least the distal end of the elongated member and the image capturing structure is dimensioned for insertion into the patient's uterus through cervix, where the control unit comprises handling means for handling release of a fluid medium at the distal end of the elongated member, and where the handling means comprises a pump located in the control unit.

25. The device according to claim 24, wherein the pump is arranged for pumping the fluid through the elongated member.

26. The device according to claim 24, comprising at least one release opening at the distal end of the elongated conduit for release of the fluid medium.

27. The device according to claim 24, wherein the pump is connectable to an external source of fluid.

28. The device according to claim 24, where the elongated member forms an S-shaped portion.

29. The device according to claim 28, wherein the elongated member forms an elongated conduit between a proximal opening and a distal opening, and where the distal opening is in the S-shaped portion.

30. The device according to claim 28, comprising at least one release opening for release of the fluid medium, the release opening being located in a forward or an intermediate s-portions or between a rearward s-portion and the intermediate S-portion.

31. The device according to claim 30, wherein at least one release opening forms a nozzle directing the fluid medium across the image capturing structure to prevent blood or tissue from blocking and preventing capturing of images.

32. The device according to claim 24, wherein the elongated member comprises a sealing member configured to seal against the cervix, and the pump is configured to provide a pressure which is sufficient for distending the uterus and thereby provide a better visualization of the lining.

33. The device according to claim 24, wherein the control unit houses heating means for heating the fluid medium.

34. The device according to claim 24, comprising a second fluid conduit configured to allow the fluid medium to flow from the uterus out through the elongated member.

35. The device according to claim 24, further comprising a pressure sensor and an electronic circuit configured to control the pump in relation to the pressure.

36. The device according to claim 24, where the elongated member is rotatably connected to the control unit.

37. The device according to claim 36, where the rotation is limited by mechanical stop members.

38. The device according to claim 36, where the rotatable elongated member is connected to the control unit with at least one electrical wire to allow the control unit to communication with the image capturing structure, where the rotatable elongated member is connected to the control unit with at least one hose to allow the control unit to communicate fluid communication with the elongated member, and where at least one of the wires or one of the hoses are slack to allow rotation of the elongated member relative to the control unit.

39. The device according to claim 24, where the control unit comprises a monitor.

Description

DETAILED DESCRIPTION

[0071] In the following, embodiments of the invention will be described in further details with reference to the drawing in which:

[0072] FIG. 1 illustrates an internal tissue visualization device according to the invention and a tool inserted in an elongated conduit;

[0073] FIG. 2 illustrates an internal tissue visualization device comprising a monitor mounted on the control unit according to the invention;

[0074] FIG. 3 illustrates the image capturing structure at the distal end of the elongated member;

[0075] FIG. 4 illustrates the distal end of the elongated member in an embodiment where the image capturing structure 6 is displaced from a center axis to provide space for an elongated conduit for the tool;

[0076] FIG. 5 illustrates the image capturing structure seen from the distal end image capturing structure and being displaced to provide unhindered passage for the tool through the elongated conduit;

[0077] FIG. 6 illustrates the image capturing structure from the distal end image capturing structure and not being displaced;

[0078] FIG. 7 illustrates an embodiment comprising the knob for rotating the elongated member 3 relative to the control unit;

[0079] FIG. 8 illustrates internal components;

[0080] FIG. 9 illustrates an embodiment of the device with an S-shaped portion of the elongated member in a perspective view;

[0081] FIG. 10 illustrates the embodiment of FIG. 9 in a cross sectional view; and

[0082] FIGS. 11-13 illustrate different shapes being considered within the definition of an S-shape.

[0083] It should be understood that the detailed description and specific examples, while indicating embodiments of the invention, are given by way of illustration only, since various changes and modifications within the spirit and scope of the invention will become apparent to those skilled in the art from this detailed description.

[0084] The tissue visualization device comprises an image capturing structure configured to capture picture of a desired tissue. The image capturing structure may be configured for non-electrical capturing or for electrical capturing of pictures. An example of an image capturing structure for non-electrical capturing is a lens by which the picture is transferred through the elongated member to a camera in the control unit. An example of an image capturing structure for electrical capturing is a camera, e.g. based on one or more CCDs sensitive in one or more wave length. The electrically captured picture is transferred by electrical cables through the elongated member to the control unit. The pictures could be still pictures and/or video by use of any method and format known per se.

[0085] The device comprises an elongated 3 member extending from a proximal end 5 to a distal end 4, the image capturing structure 6 is disposed at the distal end of the elongated member. The elongated member is fixed to the control unit, but it could also be releasable from the control unit.

[0086] The control unit 1 forms a housing for different electronic components. Particularly, the control unit houses a battery, a controller for processing data from the image capturing structure, and optionally communication means, e.g. comprising wireless transmission means, for transmitting the pictures to external systems. The control unit may further house a fluid pump 17 and pressure sensor. Further, the control unit may house heating means for heating fluid and/or for heating the elongated member. Further the control unit forms a handle 2 adapted to fit in the hand of the user, further the control unit 1 comprises an interface where the user can interact with the electronics, e.g. for controlling settings of the image capturing structure, pumping pressure, and heating etc.

[0087] The distal end holds the image capturing structure. In one embodiment, the image capturing structure is movable relative to the elongated member. The movability of the image capturing structure may be obtained e.g. by suspending the image capturing structure via an elastically deformable structure, e.g. a rubber belt or by a spring structure.

[0088] Generally, the elongated member may be rigid and dimensionally stable such that it forms a good support for tools in the elongated conduit and such that it is insertable e.g. through cervix and such that the image capturing structure can be manipulated by manipulation of the control unit. The elongated member could e.g. be made of a rigid material such as metal or a plastic.

[0089] FIG. 3 illustrates an embodiment where the distal end of the elongated member forms a cut-away section 9 starting from the distal end and extending inwardly. In the cut-away section, the distal end of the elongated member forms an extended member 12 which covers at most 180 degrees of the circumference thereby leaving at least 180 degrees free. In this embodiment, the image capturing structure 6 may be disposed in the cut-away section 9 adjacent, and supported by the extended member 12. An elastic deformable member 7 is disposed around the image capturing structure and around the extended member 12. The elastic deformable member 7 may form a ring-shape, it may e.g. be in the form of a tube or a sheath extending from a point near the distal end and covering at least the cut-away section. The elastic deformable member 7 is configured to hold the image capturing structure 6 in such a way that it is biased towards the extended member 12.

[0090] The elongated conduit may form a guide for tools to be inserted through the elongated member. The conduit extends between opposite proximal and distal openings. In the embodiment illustrated in FIG. 5, the distal opening 8 is illustrated. The image capturing structure 6 and the extending member 12 are configured such that a tool which is introduced in the elongated conduit will displace the image capturing structure relative to the extended member so that a passage is formed for the tool to pass the image capturing structure. An LED 13 is arranged to illuminate uterus.

[0091] The elongated member 3 is relatively long and slim to reduce discomfort for the patient during insertion. The elongated conduit may be used for inserting tools such as a scissor, a forceps or a morcellator etc.

[0092] Further the elongated member 3 comprises at least one conduit allowing fluid to be introduced e.g. into the utero during the surgery. The fluid is injected though an opening at the distal end. Such fluids may typically be injected to expand the uterus during a medical procedure or it may be injected to flush clear the image capturing structure and thereby create a clear sight. The elongated member 3 may include a second, fluid conduit that allows the fluid from the uterus to flow out through the elongated member 3, e.g. for collection at the control unit and/or for collection in an external reservoir. This will enable circulation of the fluid in the uterus and provide good visibility in the uterus.

[0093] According to the invention the control unit comprises an interface where the user can control different functions related to the image capturing structure, to the pump and fluid flow, to heating of the fluid and/or the elongated shaft, or for controlling bending of the elongated shaft. As an example, the control unit may house different electronics for image processing and for storage and transmission of data, and the user interface may allow picture saving, record video, zoom, light intensity and desired pump pressure. The interface may comprise push buttons, toggle keys, a touch screen, or similar interaction means.

[0094] Referring to FIG. 8, the control unit may contain different components. A pump 19 may be disposed in the control unit and configured for pumping fluid from an external reservoir into the uterus. The pump is provided with an inlet 20 and an outlet 21. The outlet is connected to a first fluid conduit through the elongated member 3, and the inlet forms an external connector outside the control unit making the pump connectable to an external reservoir containing the fluid. A second fluid conduit through the elongated member 3 ends in an external outlet 22 for release of fluid from the uterus.

[0095] A pressure sensor 23 may be provided between the pump and the first fluid conduit. Both the pump and the pressure sensor are connected to the electrical circuit 17 in the control unit. The electrical circuit 17 is configured to control the pump in relation to the pressure. For this purpose, it reads signals from the pressure sensor 21 such that a fixed or at least a predetermined pressure can be maintained in the utero. The pressure could be controlled by the user or it could be pre-programmed into the electronic circuit.

[0096] In one embodiment, the elongated member is rotatable relative to the control unit. The elongated member extends at least partially through the control unit, where the elongated member 3 is suspended in bearings 18 fixed within the control unit. The elongated member is provided with a toggle wheel 24 (Cf. FIG. 7) outside adjacent the control unit, that allows the user to easily manipulate the angular position of the elongated member 3. The toggle wheel may have a number of protrusions that allows a firm grip; The toggle wheel 24 is located close to the handle and can therefore be toggled with a finger of that hand which holds the control unit.

[0097] To allow the image capturing structure to communicate with the control unit and the pump to be in fluid communication with the conduits in the elongated member, the elongated member is connected by electrical wires and fluid conduits. Said connection is configured to allow the elongated member 3 to rotate freely without obstructing the electrical or fluid communication.

[0098] According to the invention the fluid connection might constitute a slack tube that allows the elongated member 3 to rotate at least a part of full rotation alternatively the elongated member 3 may be fitted with a fluid swivel connection. The electrical connection might constitute a slack wire that allows the elongated member 3 to rotate at least a part of a full rotation.

[0099] In one embodiment the tissue visualization device comprises a monitor 11 for displaying pictures captured by the image capturing structure and/or for user interaction, e.g. for adjusting different settings. The monitor could be a touch screen, and it could be releasably connected to the control unit.

[0100] The control unit may comprise a radio transmitter and the control unit may comprise an electrical circuit configured to transform the image signal from the image capturing structure into a radio signal for transmission to an external device. The external device could be a monitor. The connector 25 enables wired connection to a power supply and/or it enables transmission of data to external devices. The wired connection could be for the video signal to be transmitted, and it could therefore be a DVI cable, a HDMI, a Composite cable or other suitable standard cable.

[0101] FIGS. 9 and 10 illustrate an S-shaped portion 26 of the elongated member. Due to the S-shape, the image capturing structure 6 and the distal opening 8 of the elongated conduit becomes off-set by the distance indicated by the arrow 27. A tool which is in the elongated conduit may therefore pass the image capturing structure unhindered.

[0102] The S-shaped portion forms a forward S-portion the extend of which is illustrated by arrow 28, and a rearward S-portion the extend of which is illustrated by arrow 29. The forward and rearward S-portions are joined by an intermediate S-portion the extend of which is illustrated by arrow 30. The intermediate S-portion extends transverse to the forward and rearward S-portions.

[0103] In the illustrated embodiment, the forward and rearward S-portions extend essentially in parallel, and the rearward S-portion is in line with the remaining part of the elongated member. Accordingly, the rearward S-portion may be completely integrated in the remaining elongated member such that no visual transition exists.

[0104] The elongated member of this embodiment of the device comprises a proximal portion forming the proximal end and a distal portion forming the distal end, the proximal portion and the distal portion having different bending characteristics. More particularly, the rearward S-portion has a reduced bending moment as compared to the bending moment of the remaining parts of the elongated member. The reduced bending moment is established by the illustrated slots 31. Alternatively, the reduced bending moment could be established by different material characteristics, particularly relative to elastic deformation and/or by different dimensions.

[0105] In the illustrated embodiment, the forward S-portion and the rearward S-portion obtains different bending characteristics due to the aforementioned slots 31.

[0106] the distal opening 8 is between the rearward S-portion 29 and the intermediate S-portion 30.

[0107] FIGS. 11-13 illustrate three different lines 32 illustrating the shape of the elongated member 3. In FIG. 11, the intermediate S-portion 30 points in a forward direction towards the distal end of the elongated member, in FIG. 13, the intermediate S-portion 30 points in a rearward direction towards the proximal end of the elongated member, and in FIG. 12 the intermediate S-portion is perpendicular to the forward and rearward S-portions. The Angle of the intermediate S-portion relative to the forward and rearward S-portions may particularly be less than plus or minus 70 degrees from perpendicular, such that the intermediate S-portion forms an angle between 20 and 170 degrees to the longitudinal direction of the elongated member. The longitudinal direction is illustrated by the line 33. The line 33 also illustrates the direction of a tool through the internal conduit.

LIST OF NUMBERED EMBODIMENTS

[0108] 1. A device for visualization of internal tissue of a patient's uterus, the device comprising a hand-held control unit, an elongated member, and an image capturing structure, the control unit being dimensioned to be held by a user's hand and including a monitor, the elongated member having a proximal end connected to or connectable to the hand-held control unit and a distal end holding the image capturing structure, where the image capturing structure is configured to communicate video signals with the monitor, and where at least the distal end of the elongated member and the image capturing structure is dimensioned for insertion into the patient's uterus through cervix.

[0109] 2. A device according to embodiment 1, where the image capturing structure is movable relative to the distal end of the elongated member.

[0110] 3. A device according to embodiment 2, where the image capturing structure is connected to the distal end by elastically deformable means.

[0111] 4. A device according to any of the preceding embodiments, where the elongated member forms an elongated conduit between a proximal opening and a distal opening.

[0112] 5. A device according to embodiment 4, comprising a valve structure configured to seal between an inner surface of the elongated conduit and an outer surface of an instrument arranged in the elongated conduit.

[0113] 6. A device according to any of embodiments 2-3 and any of embodiments 4-5, where the image capturing structure is movable between a first position in which it at least partly hinders passage through the elongated conduit and a second position providing unhindered passage through the elongated conduit.

[0114] 7. A device according to any of the preceding embodiments, where the image capturing structure comprises a camera and an electronic circuit for converting the image into an electrical signal.

[0115] 8. A device according to embodiment 7, where the electrical signal is a communicated in analogue form.

[0116] 9. A device according to any of the preceding embodiments, comprising heating means configured to heat the elongated member.

[0117] 10. A device according to any of the preceding embodiments, where the control unit comprises handling means for handling release of a fluid medium at the distal end of the elongated member.

[0118] 11. A device according to embodiment 10, where the handling means comprises a pump.

[0119] 12. A device according to embodiment 10 or 11, comprising heating means configured to heat the fluid medium.

[0120] 13. A device according to any of embodiment 1-12 where the elongated member is rotatably connected to the hand piece.

[0121] 14. A device according to embodiment 13 where the rotatable elongated member can be rotated at least a part of a circle, and where the rotation is limited by stop members.

[0122] 15. A device according to embodiment 13 or 14 where rotatable elongated member is connected to the control unit with at least one electrical wire to allow the control unit to communication with the image capturing structure,

[0123] 16. A device according to any of embodiments 13-15, where rotatable elongated member is connected to the control unit with at least one hose to allow the control unit to communicate fluid communication with the elongated member.

[0124] 17. A Device according to any of embodiments 15 or 16, where at least one of the wires or one of the hoses are slack to allow rotation of the elongated member relative to the control unit.

[0125] 18. A device according to any of embodiments 15-17, comprising a swivel forming a fluid outlet out of the control unit and a fluid inlet into the elongated member, the swivel being configured to that maintain a stationary position of the fluid outlet relative to the control unit when the elongated member is rotated relative to the control unit.

[0126] 19. A method of carrying out hysteroscopy by use of a device according to any of the preceding embodiments, the method comprising the step of heating the elongated member, the subsequent step of inserting the elongated member into uterus of the patient, and the step of capturing images in the uterus by use of the camera.

[0127] 20. A device for visualization of internal tissue of a patient's uterus, the device comprising a hand-held control unit and an elongated member, the control unit dimensioned to be grasped by a user's hand and including a monitor, the elongated member having a proximal end in irremovably fixed connection with the hand-held control unit and a distal end with a camera where the camera is configured to communicate video signals with the monitor, and wherein the elongated member is dimensioned for insertion into the patient's uterus.

[0128] 21. An internal tissue visualization device comprising a hand-held control unit and an elongated member, the control unit including a monitor and the elongated member having a proximal end fixed connected to the hand-held control unit and a distal end with a camera, where the camera is configured to communicate image data to the control unit, and where the control unit is configured to compensate for different orientations of the camera relative to a horizontal plane.