Device for use in a surgical procedure in the area of the rectum

Abstract

The invention relates to a device for use in a surgical procedure in the area of the rectum, in particular when setting a purse-string suture for treating a haemorrhoid prolapse, comprising an insertion body (2) for insertion into a rectum, the insertion body (2) having an access opening (3), and comprising a closure part (4) which is designed to at least partially close the access opening (3), access to the access opening (3) being successively enabled by an opening movement of the closure part (4) relative to the insertion body (2), wherein a securing mechanism (5) is provided which inhibits a movement of the closure part (4) relative to the insertion body (2) substantially opposite the opening movement.

Description

[0001]

[0002] Device for use in a surgical procedure in the area of ​​the rectum

[0003] The present invention relates to a device for use in a surgical procedure in the region of the rectum, in particular in the placement of a gathering suture for the treatment of a hemorrhoid prolapse according to the features of claim 1.

[0004] Known devices of the state of the art have:

[0005] - an introducer body for insertion into the rectum, the introducer body having an access opening, and

[0006] - a closure part which is designed to at least partially close the access opening, wherein the access opening can be successively opened by an opening movement of the closure part relative to the insertion body.

[0007] State-of-the-art devices are known, for example, from EP 1683473 A1.

[0008] An example of a surgical procedure performed with this device involves inserting the introducer into the patient's rectum and placing a gathering suture to tie off prolapsing nodules and thereby reduce their volume. The gathering suture is placed successively, preferably from distal to proximal, gradually opening the access opening. For the surgeon, this gradual opening of the access opening has the advantage of optimal accessibility to the further gathering suture, because the device keeps proximal prolapsing nodules out of sight and out of the working area.

[0009] A certain risk arises from moving components that are in direct contact with the tissue. Pinching and cutting effects on component edges could cause tissue injury. This is especially true for prolapsing tissue, such as those found in hemorrhoids.

[0010] The object of the invention is to reduce this risk while maintaining the advantages of good visibility and accessibility for the surgeon as far as possible.

[0011] This object is achieved with the features of claim 1 , namely by providing a safety mechanism which inhibits a movement of the closure part relative to the insertion body which is substantially opposite to the opening movement .

[0012] One aspect of the invention is the recognition that the opening movement itself carries a very low risk of injury to adjacent tissue, whereas the risk of injury is significantly higher with other movements. Therefore, according to the invention, movements that are essentially opposite to the opening movement are selectively inhibited.

[0013] Accordingly, the locking mechanism is to be interpreted as that part of the device that functionally inhibits the movement essentially opposite to the opening movement. In preferred embodiments, a toothing and a latch can be used for this purpose. Other embodiments are conceivable, for example, in which resistance to the movement opposite to the opening movement is generated by various prestressing or surface structures.

[0014] Inhibiting the movement opposite to the opening movement can be understood, for example, to mean that the movement opposite to the opening movement is completely suppressed and cannot be achieved without destruction. In other embodiments, the movement opposite to the opening movement is prevented, due to design or manufacturing tolerances, only after a starting movement that is insignificant for the risk of injury to the adjacent tissue. Such starting movements preferably occur in the range of less than one millimeter.

[0015] The opening movement can be a rotation or a linear movement, although more complex opening movements with components of linear and rotational movements are also possible in principle.

[0016] In the case of a rotation, the movement substantially opposite to the opening movement may be substantially a rotation in the opposite direction of rotation. In the case of a linear opening movement, the substantially opposite movement may be substantially a movement in the opposite linear direction.

[0017] Among them are the fact that movements of the opening movement in the

[0018] Essentially, rather than exactly, opposite, it can be understood that, for example, manufacturing tolerances or the influence of force by a person using the device can lead to, for example, imaginary axes of movement experiencing slight changes and therefore no exactly opposite movement in the mathematical sense occurs.

[0019] The fact that the access opening can be opened successively means that between a maximally open position and a maximally closed position of the closure part relative to the insertion body, a plurality of intermediate positions exist in which a degree of opening of the access opening is realized between the maximally open and the maximally closed positions. With regard to the device, the term "successively" is therefore to be understood spatially.

[0020] The intermediate positions can be used by the surgeon during the operation to gradually release the access opening, starting from the maximum closed position to the fully open position.

[0021] The access opening does not have to be completely closed in the fully closed position of the closure element relative to the introducer body. In fact, even in the fully closed position, a defined partial opening of the access opening may be present, which can also be referred to as a ligature opening. It can be used to initially ligate a hemorrhoidal artery.

[0022] The operations explained in connection with the prior art, as well as preferably the operations explained in EP 1683473 A1, can be performed using the device according to the invention. Preferred embodiments of the invention are defined in the dependent claims.

[0023] The securing mechanism can preferably have a toothing and a, preferably spring-loaded, pawl, wherein the pawl and the toothing are designed such that the movement substantially opposite to the opening movement is inhibited by engagement of the pawl in the toothing and that the opening movement is released by the pawl engaging the toothing.

[0024] Over-engaging the pawl on the toothing means that the pawl slides backward, preferably against the spring load, over the teeth of the toothing during the opening movement. This may be accompanied by a characteristic noise, similar to that of a ratchet or ratchet.

[0025] The toothing can particularly preferably be configured such that the pawl can be brought into engagement with the toothing in one (of the mentioned) plurality of intermediate positions between a maximally closed and a maximally open position of the closure part relative to the insertion body.

[0026] The toothing can preferably be arranged on the insertion body and the pawl can preferably be arranged on the closure part, which can be structurally advantageous because the insertion body will be a larger component in most embodiments.

[0027] Embodiments in which the latch is arranged on the insertion body and the toothing on the closure part are, of course, also conceivable in principle. An operating element, in particular a button, can be provided which is designed to release the safety mechanism when actuated, so that the

[0028] Opening movement essentially opposite movement can be selectively released if this is desired in special cases.

[0029] The release of the safety mechanism upon actuation can preferably be realized in such a way that the operating element is designed to lift the pawl from the toothing upon actuation.

[0030] In preferred embodiments, the insertion body may be elongated along a longitudinal axis.

[0031] Preferably, the access opening can extend along the longitudinal axis, wherein the access opening can be successively released by the opening movement along the longitudinal axis.

[0032] The opening movement can particularly preferably be a rotation, preferably around the longitudinal axis of the insertion body.

[0033] The safety mechanism can be used for rotary

[0034] Opening movements must also be designed to inhibit axial movements of the closure part relative to the insertion body. The above explanations regarding the interpretation of the word "inhibit" also apply to this measure.

[0035] An operating device may be provided which, when actuated, releases the locking mechanism, so that an axial extension movement of the closure part from the insertion body can be selectively released. If desired, the closure part can be removed as far as possible in this way and, depending on the embodiment, completely detached from the insertion body.

[0036] The operating element and the operating device can be designed as one and the same device. In other words, the operating element and the operating device can be integrated into one another.

[0037] In this case, with a first actuation force of the operating element, only the movement substantially opposite to the opening movement can be released, and with a second, stronger actuation force of the operating element, the axial removal movement of the closure part from the insertion body can be released.

[0038] For example, a spring-loaded button can be provided which, when lightly pressed, only releases the movement opposite to the opening movement and, when more firmly pressed, releases the axial extension movement.

[0039] For example, an axial stop can be provided for the pawl, wherein the axial extension movement can be inhibited by the interaction, in particular stops, of the pawl with the axial stop.

[0040] For example, it can be provided that the latch lifts over the axial stop by actuating the operating device, preferably with greater pressure, so that the axial extension movement can be selectively released by actuating the operating device. Operation of the device can be implemented particularly easily in this way.

[0041] The access opening can be preferred

[0042] - viewed in a longitudinal section of the insertion body, have an edge that runs obliquely to the longitudinal axis and

[0043] - be able to be released successively by rotating the locking part along the inclined edge.

[0044] For this feature, reference is made to Fig. 2 and the disclosure in EP 1683473 A1, in particular Figure 3 therein.

[0045] Alternatively or additionally, an opening on the closure part may have a slanted edge with an analogous function.

[0046] The insertion body can preferably

[0047] - have a cylindrical and / or torpedo-shaped basic shape and / or

[0048] - be hollow and / or

[0049] - be essentially rotationally symmetrical with respect to the longitudinal axis, with the exception of the access opening.

[0050] The cylindrical and / or torpedo-shaped basic shape can be recognized as such if the access opening is imagined to be closed and / or a corresponding shell surface is imagined to be continued at the access opening.

[0051] The rotational symmetry mentioned can be a continuous or a discrete symmetry, for example, a three-fold symmetry. A three-fold symmetry is one in which a body falls on itself when rotated around the axis of symmetry by 120 ° (= 360 ° / 3 ).

[0052] This definition applies analogously to discrete symmetries of other counts.

[0053] Attachments located outside the patient may also be excluded from the symmetry of the introducer body.

[0054] In preferred embodiments, the closure part can be arranged or arranged within the insertion body.

[0055] In particularly preferred embodiments, the insertion body and the closure part have interlocking outer surfaces with openings that can be rotated relative to one another about the longitudinal axis. Depending on the rotational position, the openings of the insertion body and the closure part overlap completely or partially, whereby the access opening can be gradually opened.

[0056] In such embodiments, the openings in the outer surface of the insertion body together with the free interior of the outer surfaces are understood as access openings within the meaning of the invention, which allow the surgeon access to and view of the tissue located in the area of ​​the overlapping openings.

[0057] An ultrasound transmitter and receiver can particularly preferably be provided on the closure part and / or the insertion body. This allows an imaging and / or audio recording procedure to be performed, allowing the surgeon to localize a hemorrhoidal artery running in the intestinal wall. The design of the ultrasound transmitter and receiver, as well as the evaluation of the signals and their visual representation and / or acoustic reproduction, are known in the art.

[0058] The closure part and / or the insertion body can, for example, have a handle as an attachment part, which remains outside the patient even when in use and can be used by the surgeon to carry out the opening movement.

[0059] In particularly preferred embodiments, control and / or evaluation electronics for the ultrasonic transmitter and receiver can be arranged or can be arranged within the handle.

[0060] Further advantages and details of the invention will become apparent from the figures and the accompanying description. They show:

[0061] Fig . 1 is a schematic perspective

[0062] Representation of an embodiment of the invention,

[0063] Fig . 2 a partially exploded

[0064] Representation of the embodiment from Fig.

[0065] 1

[0066] Fig. 3a to 3d reduced schematic representations of the embodiment of Fig. 1 in four positions,

[0067] Fig. 4a to 4d further reduced schematic representations of the embodiment of Fig. 1 in four positions,

[0068] Fig. 5a to 5c show various reduced schematic representations of the embodiment of Fig. 1, Fig. 6a to 6c show various schematic representations of the insertion body of the embodiment of Fig. 1 and

[0069] Fig. 7a to 7c are highly schematic drawings of an embodiment of a safety mechanism.

[0070] Fig. 1 shows a schematic perspective view of an embodiment of a device 1 according to the invention for use in a surgical procedure in the region of the rectum, in particular when placing a gathering suture for treating a hemorrhoid prolapse.

[0071] The device comprises an elongated insertion body 2 and a closure part 4, wherein an access opening 3 of the insertion body in the position shown in Fig. 1 is not exposed by the closure part except for a ligature opening 12 - see Fig. 5a.

[0072] The closure part 4 can be rotated relative to the insertion body 2, whereby the access opening 3 can be gradually opened. In the present embodiment, this

[0073] Opening movement a clockwise rotation.

[0074] For this feature, reference is made to Fig. 2 and the disclosure in EP 1683473 A1, in particular Figure 3 therein.

[0075] The movement opposite to the opening movement, namely the counterclockwise rotation of the closure part 4 relative to the insertion body 2, is inhibited by a locking mechanism 5, for which reference is made to Figures 3a to 3d and 4a to 4d.

[0076] A handle 14 is provided on the closure part. Brackets 13 are arranged on the insertion body 2 and serve to position and hold the device.

[0077] Fig. 2 shows the insertion body 2 and the closure part 4, each partially exploded. Sloping edges 10 are provided on both the insertion body 2 and the closure part 4.

[0078] From Fig. 2 it can be seen that in the insertion body 2 arranged state of the closure part 4 the access opening

[0079] 3 can be released successively by rotating the closure part along the oblique edges 10.

[0080] In alternative embodiments, only one oblique edge may be present on the insertion body 2 or on the closure part 4.

[0081] Fig. 3a to 3d schematically show the insertion body 2 without the brackets 13 together with the closure part 4 in an axial view, showing various positions during the opening movement. The starting point of the opening movement is the position in Fig. 3a.

[0082] As mentioned, the locking part is used for the opening movement

[0083] 4 is turned clockwise until the end position shown in Fig. 3d is reached. In this position, the access opening 3 is completely open. Figs. 3b and 3c show intermediate positions.

[0084] The locking mechanism 5 ensures that the described opening movement can be performed, but that a movement opposite to the opening movement (here, counterclockwise rotation) is inhibited. An exemplary embodiment of the locking mechanism 5 is described in conjunction with Figures 4a to 4d.

[0085] Figures 4a to 4d show representations analogous to Figures 3a to 3d, although the closure part 4 is no longer shown except for some components belonging to the safety mechanism 5.

[0086] The securing mechanism 5 includes a circumferential toothing 6 arranged on the insertion body 2 .

[0087] The locking mechanism also includes a pawl 7, which engages the teeth and thus inhibits the rotational movement opposite to the opening movement. The opening movement itself is made possible by the pawl 7 engaging individual teeth, creating the typical sound of a ratchet or wrench.

[0088] The pawl 7 and the toothing 6 are designed for this function, for example, as shown in Fig. 7a.

[0089] It should be noted that a spring element 15 is present which presses the pawl 7 into the toothing 6 .

[0090] There is an operating element 8, in this embodiment a button. By pressing the operating element 8, the latch 7 can be lifted from the toothing. This makes the movement opposite to the opening movement possible, if the surgeon specifically desires this in a specific situation.

[0091] Fig. 5a to 5c show the embodiment of Fig. 1 schematically in various representations. It should be noted that the closure part 4 partially closes the access opening 3 in the fully closed position shown.

[0092] The access opening 3 is understood to be the inner cavity of the insertion body 2 together with the opening present in the outer surface of the insertion body 2.

[0093] In the present embodiment, the access opening 3 is not completely closed even in the fully closed position of the closure part. Rather, a residual opening exists, referred to as the ligature opening 12, which can be used for the initial placement of a ligature. Subsequently, the access opening 3 can be gradually opened further, whereby the gathering suture can be continued further in a proximal direction.

[0094] An ultrasound transmitter and receiver 11 can be arranged on the closure part 4, which can be used by the surgeon to locate blood vessels in the intestinal wall, where the aforementioned ligature can then be placed, for example.

[0095] An electronic unit for the ultrasonic transmitter and receiver 11 can be accommodated in the handle 14 of the closure part 4, for which a flap 16 is provided in order to be able to insert the electronic unit into the handle and secure it therein.

[0096] Figures 6a to 6c show the insertion body 2 of the embodiment of Fig. 1 in isolation, with Fig. 6c also showing the latch 7, the spring element 15, and the operating element 8 / operating device 9. In Figs. 6a and 6b, the imaginary longitudinal axis X of the insertion body 2 is also illustrated.

[0097] Fig. 7a shows a highly schematic illustration of an embodiment of a toothing 6 as it can be used within the scope of the invention.

[0098] Also shown is the latch 7, which is spring-loaded and can therefore in principle be moved upwards in the drawing.

[0099] When the latch 7 is moved in the direction of the opening movement - indicated by an arrow from left to right - the latch 7 hits the inclined tooth profile and is thereby pushed upwards.

[0100] Finally, the pawl 7 over-engages the corresponding tooth and falls into the next "valley", producing the characteristic sound of a ratchet or creak.

[0101] During movements in the opposite direction, pawl 7 strikes the vertical flank of the corresponding tooth. Because there is no bevel, no upward force is exerted on the pawl, which therefore cannot deflect. Movement opposite to the opening movement is therefore inhibited.

[0102] Fig . 7b shows a highly schematic representation of the toothing 6 , whereby the individual teeth are not shown .

[0103] The perspective is that of a top view of the gearing

[0104] 6 when the toothing is imaginarily rolled off the longitudinal axis X. In this exemplary embodiment, the pawl 7 has an additional widening part which interacts with an axial stop 17. Regardless of where the pawl 7 is located along the toothing 6, an axial extension movement, which would move the pawl 7 upwards in the drawing, is thus inhibited.

[0105] Fig. 7c shows a highly schematic longitudinal section of the embodiment according to Fig. 7a and 7b.

[0106] It can be seen that the axial stop 17 is higher than the toothing 6 .

[0107] In Fig . 7c the state is shown in which the operating element 8 is actuated with lighter pressure so that the pawl 7 is lifted out of the toothing 6 , but not so far that the pawl 7 would also lift over the axial stop .

[0108] In this operating position, the opening movement and the opposite movement can be carried out, but not the axial execution movement to the left in the drawing.

[0109] With greater force on the operating element 8 / operating device 8, the latch 7 can be moved further upwards, so that it also lifts over the axial stop 17. The axial extension movement can then also be performed.

[0110] In alternative embodiments of the invention, the device 1 can be designed as in EP 1683473 A1 and additionally have the safety mechanism 5 as disclosed here. In further alternative embodiments, instead of a rotary opening movement, a linear

[0111] Opening movements can be used, whereby the basic principles of the invention, in particular the securing mechanism 5, can be designed analogously to the exemplary embodiments described above. In particular, the principles illustrated by means of Figs. 7a to 7c can be applied to both rotary and linear opening movements.

[0112] Key to the reference numbers:

[0113] device

[0114] A leading body

[0115] Access opening

[0116] closure part

[0117] Safety mechanism

[0118] Gearing

[0119] pawl

[0120] Control element

[0121] Operating device sloping edge

[0122] Ultrasonic transmitter and receiver

[0123] Ligature opening

[0124] bracket

[0125] Handle

[0126] spring element

[0127] flap

[0128] Axial stop

[0129] Longitudinal axis

Claims

Patent claims 1. Device for use in a surgical Intervention in the area of ​​the rectum, especially when placing a tightening suture to treat a hemorrhoid prolapse, with - an insertion body (2) for insertion into the rectum, the insertion body (2) having an access opening (3), and - a closure part (4) which is designed to at least partially close the access opening (3), wherein the access opening (3) is formed by a Opening movement of the closure part (4) relative to the insertion body (2) can be released successively, characterized in that a securing mechanism (5) is provided which inhibits a movement of the closure part (4) relative to the insertion body (2) which is substantially opposite to the opening movement.

2. Device according to claim 1, wherein the securing mechanism (5) has a toothing (6) and a preferably spring-loaded pawl (7), wherein the pawl (7) and the toothing (6) are designed such that the movement substantially opposite to the opening movement is inhibited by engagement of the pawl (7) in the toothing (6) and that the Opening movement is released by the latch (7) engaging the toothing (6).

3. The device of claim 2, wherein the toothing is configured such that the pawl is engageable with the toothing in a plurality of intermediate positions between a maximum closed position and a maximum open position of the closure member relative to the insertion body.

4. Device according to claim 2 or 3, wherein the toothing (6) is arranged on the insertion body (2) and the pawl (7) is arranged on the closure part (4).

5. Device according to one of the preceding claims, wherein an operating element (8), in particular a button, is provided which is designed to release the securing mechanism (5) upon actuation, so that the movement substantially opposite to the opening movement can be selectively released.

6. Device according to claim 4 and 5, wherein the operating element (8) is designed to lift the pawl (7) from the toothing (6) when actuated.

7. Device according to one of the preceding claims, wherein the insertion body (2) is elongated along a longitudinal axis (X) and preferably the access opening (3) extends along the longitudinal axis (X), wherein the access opening (3) is defined by the Opening movement along the longitudinal axis (X) can be released successively.

8. Device according to claim 7, wherein the opening movement is a rotation, preferably about the longitudinal axis (X) of the insertion body (2).

9. Device according to claim 8, wherein the securing mechanism (5) is additionally designed to inhibit axial movements of the closure part (4) relative to the insertion body (2).

10. Device according to claim 9, wherein an operating device (9) is provided which is designed to release the securing mechanism (5) upon actuation, so that an axial extension movement of the closure part (4) from the insertion body (2) can be selectively released.

11. Device according to claims 5 and 10, wherein the operating element (8) and the operating device (9) are designed as one and the same device, wherein with a first actuation force of the operating element (8) only the movement substantially opposite to the opening movement can be released and with a second, stronger actuation force of the operating element (8) the axial extension movement of the closure part (4) from the insertion body (2) can be released.

12. Device according to one of claims 7 to 11, wherein the access opening (3) - the access opening (3) and / or the closure part (4) viewed in a longitudinal section of the insertion body (2) has an edge (10) which runs obliquely to the longitudinal axis (X) and the access opening (3) can be successively released by rotating the closure part (4) along the oblique edge (10).

13. Device according to one of the preceding claims, wherein the insertion body (2) - has a cylindrical and / or torpedo-shaped basic shape and / or - is hollow and / or is substantially rotationally symmetrical with respect to the longitudinal axis (X) with the exception of the access opening (3).

14. Device according to one of the preceding claims, wherein the closure part (4) can be arranged or is arranged within the insertion body (2).

15. Device according to one of the preceding claims, wherein on the closure part (4) and / or on the insertion body (2) an ultrasonic transmitter and receiver (11) is provided.

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