Device for use in hysteroscopy

Abstract

A device for visualization of internal tissue of a patient's uterus having a hand-held control unit, an elongated member, and an image capturing tip. To increase the manoeuvrability of the image capturing tip, the elongated member forms a straight portion extending along a straight axis and a curved portion forming a curvature away from the straight axis, the curved portion being between the image capturing tip and the straight portion. By rotation of an inner tube in an outer tube, the image capturing structure will move along a circular path without being rotated about the centre axis of the elongated member.

Claims

1. A device for visualization of internal tissue of a patient's uterus, the device comprising a hand-held control unit being dimensioned to be held by a user's hand; an image capturing tip configured to communicate video signals with a monitor; an elongated member having a proximal end connected to the hand-held control unit and a distal end connected to the image capturing tip, the elongated member forming a straight portion extending along a straight axis and a curved portion forming a curvature away from the straight axis, the curved portion being between the image capturing tip and the straight portion, the elongated member comprising: an inner tube, the image capturing tip being fixed to an outer tube, the inner tube being rotationally suspended in the image capturing tip and suspended on the hand-held control unit in a rotational suspension; and the outer tube fixed to the hand-held control unit, the inner tube being rotational in the outer tube and comprising a rigid inner section extending inside a flexible outer section of the outer tube in an axial direction, the rigid inner section having a curvature which forms the curvature of the curved portion by deflection of the flexible outer section; an outer conduit between the outer tube and the inner tube; and an inner conduit within the inner tube, the outer conduit extending between an outer inlet and an outer outlet, and the inner conduit extending between an inner inlet and an inner outlet, wherein the rotational suspension of the inner tube in the image capturing tip forms a liquid tight connection to the inner conduit to thereby prevent mixing of fluid in the inner and outer conduits.

2. The device according to claim 1, wherein the flexible outer section comprises: a stiffening spring-element having radial stiffness but being bendable; and a bendable sheath covering the spring-element.

3. The device according to claim 2, wherein the image capturing tip is fixed to the outer tube via the stiffening spring-element.

4. The device according to claim 2, wherein the outer tube comprises a stiff outer section in continuation of the flexible outer section.

5. The device according to claim 4, further comprising a coupling element forming a first space and a second space between an outer housing and an inner divider, the outer tube being fixed to the outer housing, the inner tube being fixed to the inner divider, the first space being in fluid communication with the inner conduit, the second space being in fluid communication with the outer conduit, and the inner divider being rotationally received in outer housing.

6. The device according to claim 1, wherein the image capturing tip forms an extension conduit from the inner outlet to a distal release opening.

7. The device according to claim 1, wherein the outer inlet is between the image capturing tip and the curved portion.

8. The device according to claim 1, comprising a torsion element resisting rotation of the image capturing tip relative to the hand-held control unit.

9. The device according to claim 8, wherein the torsion element extends between the image capturing tip and the hand-held control unit.

10. The device according to claim 8, wherein the torsion element constitutes an electrical connection between the image capturing tip and the control unit.

11. The device according to claim 1, comprising a control knob fixed to the inner tube and being operable for rotating the inner tube in the outer tube.

12. The device according to claim 1, wherein the image capturing tip forms an S-shaped portion forming an intermediate section extending transverse to opposite first and second ends, the first end forming an image capturing structure and the second end being fixed to the outer tube.

13. The device according to claim 1, wherein the image capturing tip forms a straight shape being within a dimension of a cross section of the elongated member when projected onto a plane perpendicular to an axial direction of the elongated member.

14. The device according to claim 1, wherein the curved portion forms an angle of at least 15 degrees to the straight axis.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) In the following, embodiments of the invention will be described in further details with reference to the drawing in which:

(2) FIGS. 1a and 1b illustrates an internal tissue visualization device according to the invention and a tool inserted in the tool conduit;

(3) FIGS. 2a and 2b illustrate an internal tissue visualization device comprising a monitor mounted on the control unit according to the invention;

(4) FIGS. 3-4 illustrate internal components of the hand-held control unit;

(5) FIG. 5 illustrates schematically internal components of the device;

(6) FIG. 6 illustrates a cross section of the image capturing tip;

(7) FIG. 7 illustrates an exploded view of the elongated member;

(8) FIGS. 8A and 8B illustrate enlarged views of two different embodiments of a housing for the image capturing tip;

(9) FIG. 9 illustrates an exploded view of the coupling;

(10) FIGS. 10 and 11 illustrate an S-shaped image capturing tip and an alternative embodiment of the flexible outer section of the outer tube;

(11) and FIGS. 12-13 illustrate a straight image capturing tip.

DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

(12) 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.

(13) Referring to FIGS. 1a, 1b, 2a, and 2b, the tissue visualization device 1 comprises an image capturing structure configured to capture pictures of tissue.

(14) The device 1 comprises a hand held control unit 2 and an elongated member 3 connected to the control unit 2. The elongated member extends from a proximal end 4 to a distal end 5. The distal end is shown in FIG. 1b illustrating that the curved portion forms an angle of 20 degrees to the straight axis. The curved distal end is also only shown in FIG. 2a.

(15) FIG. 1s illustrates a surgical tool 6 which is inserted in a tool conduit of the elongated member.

(16) FIG. 2a illustrates a monitor 7 which can visualize the captured images. The monitor is attached to the hand held control unit to thereby enable use of the device completely independent on fixtures of an operating room.

(17) FIG. 2a illustrates the entire elongated member including the straight portion 8 and the curved portion 9. The curved portion is between the image capturing tip 10 and the straight portion.

(18) Generally, the elongated member 3 may be rigid and dimensionally stable such that it forms a good support for tools in the elongated tool 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 plastic. The elongated member 3 is relatively long and slim to reduce discomfort for the patient during insertion. The elongated tool conduit may be used for inserting tools such as a scissor, a forceps or a morcellator etc.

(19) FIG. 2b illustrates a cross-section of the elongated member perpendicular to a center axis of the elongated member. In the herein disclosed embodiments, the elongated member has a circular cross section with an outer diameter of 4 mm. The elongated member forms an elongated tool conduit with a circular cross section and a having a smallest diameter of 2 mm.

(20) The elongated member comprises an inner tube 24, and an outer tube 25. The inner tube is configured to rotate inside the outer tube and comprises a rigid inner section 69 (see FIG. 7) axially coextending a flexible outer section of the outer tube. The rigid inner section has a curvature and due to its rigidity, it deforms the flexible outer section and thereby forms the curvature of the curved portion 9 by deflection of the flexible outer section.

(21) The control knob 11 is fixed to the inner tube and thereby enables a user to rotate the inner tube by rotation of the control knob.

(22) The inner conduit within the inner tube allows fluid to be introduced into the uterus during surgery. Such fluids may typically be injected to expand the uterus during a medical procedure, or it may be injected to flush the image capturing structure and thereby create a clear sight. The fluid from the uterus is allowed to drain through the outer conduit between the inner tube and the outer tube. By this structure, fluid may constantly be circulated in the uterus and provide good visibility.

(23) FIGS. 3 and 4 illustrate internal components of the device. The hand held control unit 2 houses a fluid system including an inlet 12 for entering fluid through the inner conduit into the uterus and an outlet 13 for draining fluid from the uterus through the outer conduit. The inlet 12 and outlet 13 are connected via the coupling 14.

(24) FIG. 5 schematically illustrates further elements housed in the control unit 2. Particularly, the control unit houses a battery 15, a controller 16 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 further houses a pressure sensor 17. The control unit may further comprise a flow control valve 18 for controlling the flow of liquid in the inner conduit. The liquid is used for flushing the image capturing structure and/or for extending the uterus.

(25) The coupling 14 forms, in one end, the control knob 11, c.f. also FIG. 2. The coupling will be explained in further details later.

(26) The control unit has the shape of a handle 19 adapted to fit in the hand of the user, further the control unit 2 comprises an interface 20 by which the device may communicate with external devices.

(27) FIG. 6 illustrates the curved portion 9 of the elongated member. In this view, the inner conduit 21 and the outer conduit 22 are clearly seen. The outer conduit 22 may extend between an outer inlet 70 and an outer outlet, and the inner conduit 21 may extend between an inner inlet and an inner outlet. The inner conduit may be constituted by the tool conduit, and in that case, the inner outlet may be constituted by the distal tool opening.

(28) The image capturing tip 10 extends distally from the curved portion. The image capturing tip may have different shapes and will be explained in further details later. The inner tube 24 has a bended, curved shape and it is rigid at least concerning that part which is bended. The inner tube is, in the distal end, supported rotationally in a recess in the image capturing tip 10. The image capturing tip thereby forms a bearing for rotation of the inner tube relative to the image capturing tip.

(29) The outer tube 25 comprises a two layer structure with an inner layer of a radially incompressible but yet bendable material such as spring, or a soft bendable, yet radially stiff material and an outer layer formed as a sheath of a soft pliable material, e.g. rubber. This is explained further with reference to FIG. 7.

(30) FIG. 7 illustrates the elongated member and the image capturing tip in a dis-assembled configuration. The elongated member comprises a rigid inner tube 24 with a curved shape. The inner tube is received in an outer tube. The outer tube has a two layered structure with an inner layer constituted by the tube 25. This inner layer tube comprises a flexible outer section 26 and a rigid outer section 27. The rigid outer section is made from steel and the flexible outer section is constituted by a helical spring or other bendable material with torsional rigidity allowing the inner tube to be rotated within the outer tube with out twisting the outer tube.

(31) At the distal end of the elongated member, the flexible outer section of the outer tube is fixed to the flange 28 at the proximal end of the image capturing tip 10. The inner tube is received in a rotational bearing 29 formed inside the flange 28 in the proximal end of the image capturing tip 10.

(32) The rotational bearing allows the inner tube to rotate concentrically within the outer tube. Since the image capturing tip is fixed to the outer tube, rotation of the inner tube will cause the body of the image capturing tip 10 to make a translatory movement along a circle, i.e. a movement where all points within the body are moving at the same velocity and in the same direction.

(33) The image capturing tip may have different shapes. In FIG. 7, the image capturing tip has an S-shaped body 30 forming the mentioned attachment of the outer tube the flange 28 and the bearing 29 inside the flange.

(34) An LED structure 31 with two LEDs, a glass layer 32 and a lens 33. A cap 34 holds the LED structure, the glass layer and the lens fixed to the S-shaped body 30.

(35) The torsion element 35 extends between the image capturing tip and the hand-held control unit and forms in the distal end, a CCD 36. The torsion element forms a printed circuit board establishing electrical communication between the hand-held control unit and the CCD, and optionally also with the LED structure.

(36) The outer tube has, as previously mentioned, a two layered structure with an inner layer constituted by the tube 25. This tube is covered in its entire length by the cover sheath tube 37. In an alternative embodiment, the cover sheath tube 37 covers only the flexible outer section. This is important, e.g. when the flexible outer section is water permeable, e.g. a helical spring. In this case, the cover sheath makes the outer tube water tight.

(37) FIGS. 8A and 8B illustrate different embodiments of the image capturing tip.

(38) In FIG. 8A, the image capturing tip has an S-shaped body. In this view, the flange 28 is shown with two projections 38, 39. The projections 38, 39 engage the windings of the helical spring which forms the flexible outer section 26 of the outer tube and thus fixes the outer tube to the image capturing tip.

(39) The image capturing tip further comprises a tool conduit 40 forming an extension of a tool conduit through the elongated member. The tool conduit is indicated by the dotted lines in FIG. 8A and facilitates insertion of a tool through the elongated member and through half of the image capturing tip. The S-shape of the image capturing tip allows the tool to be inserted next to the camera and lens portion 41. The opening 42 allows the torsion element 35 to enter from the elongated member into the S-shaped tip portion where it can connect to electric devices, e.g. for signal transmission or for conducting electrical power to the LED etc.

(40) In FIG. 8B, the image capturing tip extends along a straight line as an extension of the elongated member. Again, the image capturing tip forms a tool conduit 40a in extension to the tool conduit 40b in the elongated member. The camera and lens portion 41 is moulded in a transparent plastic material and houses the LED 31 and the CCD 36.

(41) The CCD and LED are wired through the elongated member by the torsion element 35.

(42) FIG. 8B illustrates that the tool conduit has a smaller cross sectional size at the image capturing tip than in the elongated member.

(43) FIG. 8B further illustrates the outer conduit 40c.

(44) FIG. 9 illustrates an exploded view of the coupling 14. The outer housing 43 forms a distal tip 44 shaped as a flange for receiving the outer tube thereon. The inner divider 45 forms three outward flanges 46, 47, 48 holding two sealing O-rings 49, 50. The O-rings establish a forward chamber and a rearward chamber. The forward chamber is located distal to the flange 48 and the rearward chamber is located between the flanges 46 and 47. The rearward chamber is in communication with the inner inlet 51 and forms an opening 52 into the inner conduit in the inner tube. The forward chamber is in communication with the outer outlet 53 and allows fluid drained from the uterus through the outer conduit between the inner and outer tube to be drained from the device.

(45) The inner tube is fixed to the distal tip 54 of the divider 45 and the control knob 11 (comparable to the control knob 11 in FIG. 2) is fixed to the divider 45. By rotation of the control knob, the inner tube is rotated within the outer tube, and due to the curved shape of the inner tube, the image capturing tip is caused to move in a translator movement along a circular path.

(46) FIGS. 10 and 11 illustrate an S-shaped image capturing tip 10 and an alternative embodiment of the flexible outer section 26 of the outer tube. Due to the S-shape, the image capturing structure with lens and CCD 36 and the distal opening 59 of the tool conduit becomes off-set by the distance indicated by the arrow 60. A tool which is in the elongated conduit may therefore pass the image capturing structure unhindered.

(47) The elongated member of this embodiment has an outer tube with a flexible outer section 26 where the flexibility is obtained by reducing the bending moment by the illustrated slots 61.

(48) FIG. 11 illustrates three different sections 62, 63 64 illustrating the S-shape of the S-shaped image capturing tip. Whereas the forward and rearward sections 62, 64 are parallel, the intermediate section 63 is transverse to the other sections

(49) The Angle of the intermediate section 63 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.

(50) FIGS. 12 and 13 illustrate a straight image capturing tip 10 where the tool conduit 66 and the image capturing structure in the form of the CCD 36 are located within the dimension of the cross section of the elongated member. By this is meant that the image capturing tip can be projected onto a plane which is perpendicular to the distal end of the elongated member and thereby be within the dimension of the elongated member or at most have an area being 10 percent larger than the elongated member. Due to the straight shape, the image capturing tip is can be inserted more easily into the uterus through the relatively narrow cervix. The tool 68, in this case a forceps, which is in the elongated conduit may pass the image capturing structure unhindered due to the off-set between the image capturing structure and the tool conduit.