WO1996041576A1

WO1996041576A1 - Stoma holder, stoma placing process and device

Info

Publication number: WO1996041576A1
Application number: PCT/EP1996/002444
Authority: WO
Inventors: Christian Chaussy; Stefan THÜROFF
Original assignee: Angiomed Gmbh & Co. Medizintechnik Kg
Priority date: 1995-06-08
Filing date: 1996-06-05
Publication date: 1996-12-27
Also published as: DE29509370U1

Abstract

A stoma holder, in particular for a ureter stoma, has an envelope with a cylindrical contour and an axial passage, and at least two flanges that are arranged at a limited distance from each other on the envelope and extend radially outwards. At least one flange is arranged at a limited distance from both faces of the body.

Description

Stoma holder and device and method for placing a stoma

The invention relates to a holder for a stoma, in particular a ureter stoma, a device for placing a stoma, in particular a ureter stoma, and a method for placing a stoma, in particular a ureter stoma, the abdominal wall of a patient being opened , at least one body channel, such as a ureter, and a severed free end of its proximal part, such as its kidney-side part in a ureter, is passed out through the abdominal wall of the patient.

There are diseases in which the urine can no longer be drained from the kidney through the bladder, for example in the case of bladder cancer, especially if the bladder then has to be removed. In this case, kidney fistulas are known for draining urine. For this purpose, catheters are inserted transcutaneously into the kidney. There are tubular bags around the catheter on the Body flank of the patient glued on. Changing the kidney fistula is problematic.

An alternative method of the prior art is to lead the ureter out of the skin, ie to create a stoma. The passage through the skin takes place through a piece of intestine as an adapter. The intestine has to be drained surgically after it has been separated from the patient's small intestine as a 15 cm piece and has been drained through the abdominal wall with the associated blood supply. This leads to several intestinal anastomoses with corresponding complications, waxing in the abdominal cavity, doubled operating time and significantly increased operating costs. In addition, dermatosmosis can arise from urine that gets on the skin. Ureters are also delicate, delicate structures. Scars can occur. Working with an endoscope is difficult.

The invention has for its object to provide a stoma holder, a device and a method for placing a stoma, in particular a ureter stoma, with which a stoma can be quickly and easily created to avoid the aforementioned disadvantages can persist for a long time and reliably, in particular preventing the ureter from overgrowing and preventing urine from getting onto the skin, and the above Disadvantages of the intestinal skin adapter (ileum conduit) can be avoided.

According to the invention, the stated object is achieved with a stoma holder, in particular for a ureter stoma, which has a jacket with a cylindrical contour with an axial Passage and at least two with finite axial distance to each other arranged on the jacket, extending radially outwardly extending flanges, wherein a flange is arranged with a finite distance to both end faces of the jacket. Furthermore, the invention provides a device for the placement of a stoma, in particular a ureter stoma, which is characterized by a stoma holder, as described above, a needle and a device for pulling out the free end of the object Body channel, like the free end of a ureter. A method according to the invention for placing a stoma is characterized in that the abdominal wall of the patient is pierced with a needle, that the cut free end of the proximal canal part is connected to a shaft of the needle, that a stoma holder is located from the rear end of the shaft of the needle is pushed along the shaft into the abdominal wall of the patient and that the needle shaft with the end of the channel part fastened to it is pulled through the stoma holder and thus through the abdominal wall of the patient and fastened on the outside of the patient's skin.

Characterized in that a radially outwardly extending flange of the stoma holder is arranged at a finite distance from both end faces, this flange can be used as the outside contact surface of the stoma holder, with which the stoma holder on the outside of the skin or abdominal wall of the Patient lies on so that he can not slide further into the skin. The outwardly projecting end of the stoma holder, through which the free end of the ureter is pulled and coaxially slipped over, ensures that the outlet opening for the urine is included is arranged at a finite distance from the surface of the skin so that it projects into a receiving bag attached to the surface of the skin so that no urine can get onto the skin.

A preferred embodiment provides that the radially extending flanges are designed as ring flanges. In a further preferred embodiment, it can be provided that a flange is arranged on both end faces of the jacket. This also results in the stoma holder being fixed on the inside of the abdominal wall.

A further preferred embodiment provides that the peripheral wall of the jacket has openings, in particular the peripheral wall of the jacket being designed as a grid and the openings being designed as rhombuses. This makes it possible for the stoma holder itself to be sewn onto the abdominal wall and thus additionally secured. A further preferred embodiment provides that the struts limiting the openings of the cylindrical jacket extend at a finite angle <90 ° to the direction of extension of the axial passage of the jacket. The length of the stoma holder is between 10 and 20 mm, the distance between a radial flange and one end being between 2 and 4 mm. The diameter for a ureteral stoma can preferably be between 4 and 6 mm.

A further development of the device according to the invention is characterized by a handle which can be releasably fixed to an end of a shaft of the needle facing away from a needle tip. A separate handle is used to insert the needle or needle tip into the abdominal relief of the patient. Because a handle in the

Usually a needle shaft projects radially through the

Detachability allows that after removing the handle

The stoma holder can be pushed over the needle shaft and pushed into the abdominal wall.

In a further preferred embodiment it is provided that the needle has a shaft and a tip which can be detached therefrom. This enables the needle tip to be removed after the abdominal wall has been pierced and does not pose any further danger to the patient's internal organs, in particular the nearby intestine. Furthermore, in this embodiment, but also in an embodiment with a tip that is fixedly connected to the shaft and does not protrude radially therefrom, it is possible to first push the stoma holder before piercing the abdominal wall (and if necessary before screwing the needle tip onto it) Needle shaft) to push on the needle shaft up to near the end of the handle, so that later a loosening of the handle is no longer necessary and possibly a detachable handle is no longer necessary, but after piercing the abdominal wall of the stoma holder along the shaft in this can be inserted.

In a further preferred embodiment it is provided that the releasable connection between the needle shaft and the needle tip is a threaded connection with an internal and external thread. As a rule, the external thread on the shaft and the internal thread will be formed in a blind hole in the needle tip.

In order to achieve a good cross-cut and not just a hole that could tear out, a further development of the invention provides that a tip of the needle is included _ sharp cutting edges and is formed between these grooves.

To have an abutment when piercing the abdominal wall and an injury to inner areas of the

To avoid patients, the device according to the invention provides a protective cap in a further embodiment. In a preferred further development it can be provided that the protective cap is designed to detach the needle tip from the shaft, the inside of the protective cap in particular having a non-rotationally symmetrical opening adapted to the contour of the needle tip, with which the protective cap can be placed on the needle tip is, the needle tip is covered by a closed region of the protective cap.

A further development of the device according to the invention is characterized in that the device for pulling out the end of a body channel, such as an uterus, is formed by the needle shaft and a transverse bore formed at its front end. As a result, the free end of the ureter can be easily connected to the needle shaft and pulled out by pulling it out.

Further preferred refinements of the device according to the invention provide that the handle can be axially fixedly connected and detached, in particular the needle shaft has a circumferential groove and that the handle is provided with a radial slot into which a blocking element can be inserted, which has an elongated recess with an area larger than the diameter of the needle shaft and with an area smaller than the diameter of the needle shaft, however is greater than the reduced circumference of the needle shaft remaining in the area of the annular groove, and that the handle and the needle shaft can be connected to one another in a rotationally fixed manner, in particular a flat axial shoulder at the rear end of the needle shaft facing away from the needle tip and an axial slot formed in the bottom of the blind bore in the handle are.

The abdominal interior is exposed outside the "surgical abdominal cavity" (extraperitoneal) delimited by the peritoneum in a manner known per se when a stoma is placed, whereupon the above-mentioned steps of the method according to the invention are then carried out. In a preferred embodiment, it is further provided that, as stated, the abdominal wall is pierced while holding a protective cap. In order to enable the ureter to be pulled out, a preferred embodiment provides that the free end of the ureter is connected to the shaft in that a thread is pierced through the end of the ureter, pulled through a hole in the shaft and knotted, in particular before connection of the needle shaft with the end of the ureter, a needle tip that can be removed from the shaft is removed from the latter. As mentioned, the needle tip can be twisted off using the protective cap.

Furthermore, an embodiment of the method according to the invention provides that a handle which projects radially beyond the diameter of the needle shaft is detached from the latter before the stoma holder is pushed onto the needle shaft.

After pulling the free end of the ureter through the stoma holder and coaxially turning it over the end protruding from the skin and fitting the end of the l separated body canal, especially ureter, on the

In a further preferred embodiment, skin is provided such that the free end of the body channel drawn through the stoma holder is sewn onto the stoma holder and / or the outside of the patient's skin. In principle, the stoma holder itself can also be sewn onto the patient's skin or abdominal wall for additional security.

Further features and advantages of the invention result from the claims and from the following description, in which a preferred embodiment of the invention is explained in detail with reference to the drawing. It shows:

Figure 1 shows a stoma holder according to the invention in side view.

Fig. 2 shows the stoma holder of Fig. 1 in use, i.e. inserted in the skin of a patient and with a ureter passed through it and attached to the outside;

Fig. 3 shows a device for laying a

Stomas in side view, partially cut;

Fig. 4 shows a cross section corresponding to IV-IV in Fig. 3 by the invention

Contraption;

5 shows a protective cap as part of the device for laying according to the invention _ corresponding to a stoma on average

V-V of Fig. 6;

6 shows a view according to VI in FIG. 5 of the protective cap;

7a-7c the essential steps of the method according to the invention for the placement of a stoma using the example of an uterostomy.

Part of the device according to the invention for placing a stoma is a stoma holder 1. The stoma holder 1 has a lattice-like cylindrical jacket 2 which is provided with diamond-shaped openings 3. The jacket 2 can be made, for example, of a nitinol sheet in which slots are formed axially one behind the other and distributed along the circumference, in which slots in adjacent rows are offset by approximately half their length in the axial direction. After bending to form a cylinder and connecting the longitudinal edges of such a processed sheet and subsequent heat treatment, a jacket 2 is formed, as shown in FIG. 1. Instead, the perforations can also be formed by wire sections braided one above the other. In addition to the aforementioned nickel-titanium alloy, stainless steel can also be used as the material for the stoma holder 1.

As such, the jacket 2 has an axial passage 4. Radial flanges 6, 7, 8 are fastened on the jacket 2, which are preferably designed as ring flanges in the exemplary embodiment shown. The ΛO flanges 6, 8 are attached to the end faces of the jacket 2. The flange 7 is arranged at a distance of 2 mm from the flange 6, the total length of the stoma holder 1 being 10 mm in the exemplary embodiment shown. The flanges 6, 7, 8 protrude a little radially from the jacket 2, for example up to 0.5 mm.

2 shows a stoma holder 1 according to the invention after use in the abdominal wall 11 of a patient. It can be seen that the flanges 7, 8 on the outer and

Bearing inside the abdominal wall 11 so that the stoma holder 1 with the area 9 between the flanges 7 and 6 projects beyond the outside of the abdominal wall 11. A distal, cut end of a ureter 12 is pulled through the interior 4 of the stoma holder 1 and is coaxially folded outwards at the outer outlet 10 thereof via the flange 6 and by sutures 14 on the abdominal wall 11 and sutures 16 on the stoma holder 1 sewn through its openings 3.

FIG. 3 shows a preferred embodiment of a needle 21 with a handle 22 for placing a stoma as part of a device according to the invention. The needle 21 in turn consists of a needle shaft 23 with a thread 24 and a needle tip 26 with an internal thread 27 that can be screwed onto the thread 24. The needle tip 26 is trocar-like, but has four very sharp cutting edges 28, between which grooves 29 are formed are. This allows a cross cut to be made when the needle tip 26 is inserted into the abdominal wall 11. AΛ The needle shaft 23 is provided with graduations 31 so that it can be determined how deeply the needle 21 has been inserted.

The needle shaft 23 is detachably axially and non-rotatably connected to the handle 22, which is provided at its front end with a radial ring flange 33 as a contact surface when the needle 21 is pushed into the abdominal wall 11.

The handle 22 has an axial blind bore 34 which opens into a slot 36 in its depth. The needle shaft 23 is provided on its rear end facing away from the needle 21 with a flattened axial shoulder 37 which can be inserted into the slot 36 and thus fixes the needle 21 in the handle 22 in a rotational test. For axial

Fixing the needle 21 in the handle 22, the latter has a radial slot 38 which crosses the bore 34. The needle shaft 23 is provided with a circumferential groove 39 on its circumference at a distance corresponding to the distance between the slot 36 and the radial slot 38. A blocking part 41 can be inserted into the radial slot 38, which is provided with a two-part recess 42 which resembles an upside-down keyhole for a bath key. The recess 42 has a lower region 43 which is dimensioned such that the

Shaft 23 can be pushed through the area 43. The narrower area 44 lying above has smaller dimensions than the shaft 23 and is dimensioned such that it can be pushed onto the groove 39 of the shaft 23; in this way the axial blocking of the needle 21 in the handle 22 can be ensured.

The connection between the needle shaft 23 and the handle 22 is made in a simple manner in that first the blocking element 41 approximately as far into the

Radial slot 38 of the handle 22 is inserted until the area 43 of the recess 42 is aligned with the bore 34. Then the shaft 23 is inserted into the bore 34 until the axial shoulder 37 strikes the bottom of the bore. The shaft 23 is optionally rotated somewhat under further axial pressure until the shoulder 37 penetrates into the slot 36. The blocking element 41 with its tapered region 34 can then be pushed over the groove 39, as a result of which the shaft 23 is fixed.

The release also takes place in a simple manner in that first the blocking element 41 is pulled upwards until the region 43 of the recess 42 surrounds the shaft 23, whereupon the latter passes through the region 43 of the recess 42 and out of the bore 34 of the handle 22 can be pulled out.

The needle tip 26 is fixed on the needle shaft 23 by unscrewing or unscrewing the threads 24, 27.

A transverse bore 46 is also formed on the needle shaft 23 immediately behind the thread 24, through which a thread can be pulled, which is connected to the free end 13 of the ureter 12.

The inventive device for placing a stoma also has a protective cap 51.

The protective cap 51 has the shape of a truncated cone. An outwardly projecting annular flange 53 is formed at the enlarged end 52. In the interior of the protective cap 51, a disk 57 is inserted at a distance from the bottom 56 of the tapered end 54 thereof, the disk 57 in the middle has square opening 58. The square opening 58 is dimensioned such that its dimensions (side lengths, diagonals) lie slightly below the corresponding transverse dimensions of the needle tip 26 in the area of its area adjoining the cutting edges and grooves 28, 29. The distance of the disk 57 from the bottom 56 of the protective cap 51 is such that when the needle tip 26 with its cutting edges in the area of the corners of the recess 58 is pressed firmly into the recess, the end 26b of the needle tip 26 still touches the bottom 56 of the protective cap 51 not touched.

Furthermore, the subject of the device according to the invention for placing a stoma is a stoma holder 1, as was described with reference to FIGS. 1 and 2.

7a-7c, a preferred embodiment of the method according to the invention for placing a stoma and thus the function of the device according to the invention explained above are described in detail with the essential steps.

First, a pararectal 10 cm long right-sided skin and subcutaneous incision is made, followed by longitudinal splitting of the anterior abdominal fascia. The right-sided muscle belly is loosened laterally from the fascia and the posterior rectus sheath is exposed to the caudal semilunar plica. The peritoneum adhering to the posterior rectus fascia is released by passing under the rectus fascia in the semilunar plica and stripped medially with the finger. The posterior rectus fascia is gradually opened. The peritoneum lies in the medial toto. The gerota fascia is pushed off along the lateral abdominal wall and opened at the height of the Crista iliaka. A ureter 12 leading from the kidney 62 to the urinary bladder 60 is looped and gradually prepared. The ureter is separated at the level of the vascular junction (61, Fig. 7a). The ureter 12 is now bluntly dissected up to the lower pole of the kidney 62 while protecting the periureteral vascular supply and then fixed at its free end 64 with a piercing seam 63.

Then, in the middle between the iliac crest and the tip of the rib, the needle 21 is inserted through the abdominal wall 11 perpendicular to the anterior superior spina iliaka after the protective cap 51 has previously been pressed against the abdominal wall at this point from the inside. The needle tip 26 enters the opening 28 in the protective cap 51 and is fixed by the latter in a rotationally fixed manner. It is then safely removed from the shaft 23 for the nearby intestine by rotating the protective cap 51 and, held in the protective cap 51, can be removed from the patient's abdomen.

The thread 63 drawn in at the end 64 of the ureter 12 is pulled through the bore 46 at the end of the shaft 23 and loosely knotted.

The handle 22 is detached from the shaft 23 in the manner described above and, via the rear end of the shaft 23, ie from the shoulder 37, a stoma holder 1 via the shaft 23 and into the abdominal wall 11 into the position shown in FIG. 2 position shown pushed (Fig. 7b). The free end 13 of the ureter 12 is then pulled out through the stoma holder 1 with the shaft 23 through the thread 63. The thread 63 and thus the shaft 23 are removed from the end 13 of the ureter 12. The stent can be fixed to the skin of the abdominal wall 11 with a few single puncture ligatures.

Then the end 13 of the ureter 12 is slipped over the protruding area 9 of the stoma holder 1 to the outside of the abdominal wall 11, as shown in FIG. 2, and with sutures 14, 16 on the abdominal wall 11 and the stoma Holder 1 fixed.

Until healing, the ureter 12 can be splinted in a manner known per se with a double-J catheter.

The skin and subcutis incision is closed with a continuous suture of the anterior rectus fascia after inserting a drainage into the wound bed. The posterior rectus fascia is not closed. After subcutaneous sutures and epifascial redon drainage, skin is clipped and a sterile bandage is applied.

Claims

claims

Holder for a stoma, in particular a ureter stoma, with a jacket with a cylindrical contour (2) with an axial passage (4) and with at least two flanges (6) arranged at a finite distance from one another on the jacket (2) and extending radially outwards , 7, 8), at least one flange being arranged at a finite distance from both end faces of the body.

Holder according to claim 1, characterized in that the radially extending flanges (6, 7, 8) are designed as ring flanges.

3. Holder according to claim 1 or 2, characterized gekennzeich¬ net that a flange (6, 8) is arranged on both end faces of the jacket (2).

4. Holder according to one of the preceding claims, characterized in that the peripheral wall of the

Sheath (2) has openings (3). Η ^"

5. Holder according to claim 4, characterized in that the peripheral wall of the casing (2) is formed as a grid.

6. Holder according to claim 4 or 5, characterized gekennzeich¬ net that the openings (3) are formed as diamonds.

7. Holder according to one of claims 4-6, characterized gekenn¬ characterized in that the openings (3) delimiting struts of the cylindrical shell (2) with a finite angle <90 ° to the direction of extension of the axial passage (4) of the hollow body (2) get lost.

8. Device for placing a stoma, in particular a ureter stoma, characterized by a holder (1) according to one of claims 1-7, a needle (21; 23, 26) and a device (46) for pulling out the free End (13) of a body canal, such as a ureter, (12).

9. The device according to claim 8, characterized by a handle (22) on one of a needle tip

(26) opposite end of a shaft (23) of the needle (21) is releasably fixable.

10. The device according to claim 8 or 9, characterized in that the needle (21) has a shaft (23) and a detachable tip (26).

Ig 11. Device according to one of claims 8-10, characterized in that a tip (26) of the needle (21) is formed with sharp cutting edges (28) and fillets (29) formed between them.

12. The apparatus of claim 10 or 11, characterized ge indicates that the shaft (23) and needle tip (26) by a threaded connection (24, 27) are releasably connectable.

13. Device according to one of the preceding claims, characterized by a protective cap (51) for protecting body parts of a patient against damage by the needle tip (26).

14. The apparatus according to claim 13, characterized gekennzeich¬ net that the protective cap (51) for releasing the Nadel¬ tip (26) from the shaft (23) is formed.

15. The apparatus according to claim 14, characterized gekennzeich¬ net that the protective cap (51) in its interior to the contour of the needle tip (26) adapted, non-rotationally symmetrical opening (58) with which the protective cap (51) on the needle tip (26) can be put on, the needle tip (26) being covered by a closed area (bottom 56) of the protective cap (51).

16. Device according to one of claims 8-15, characterized in that the device for pulling out the end (13) of a body channel, such as a Ure¬ ter, (12) through the needle shaft (23) and a transverse bore formed at the front end (46) is formed.

17. Device according to one of claims 9-16, characterized in that the handle (22) with the Nadel¬ shaft (23) is axially fixed and releasable.

18. The apparatus according to claim 17, characterized gekennzeich¬ net that the needle shaft (23) has a circumferential groove (39) and that the handle (22) is provided with a radial slot (38) into which a blocking element (41 ) can be inserted, which is an elongated

Recess (42) has a region (43) which is larger than the diameter of the needle shaft (23) and a region (44) which is smaller than the diameter of the needle shaft (23) but larger than that in the region of the Ring groove (39) remaining reduced circumference of the needle shaft (23).

19. Device according to one of claims 9-18, characterized in that the handle (22) and needle shaft (23) are rotatably connected to each other.

20. The apparatus according to claim 19, characterized by a flat axial shoulder (37) on the needle tip (26) facing away from the rear end of the needle shaft (23) and by an axial slot (36) formed in the handle (22) at the bottom of the blind bore (34).

21. A method of inserting a stoma, in particular a ureter stoma, wherein the abdominal wall of a patient is opened, at least one body channel, such as a ureter, is separated and a free end of its proximal part, such as its kidney-side part in a ureter, is separated through the abdominal wall the patient is led outside, characterized in that 10 the patient's abdominal wall is pierced with a needle, that the cut free end of the proximal canal part is connected to a shaft of the needle, that from the rear end of the shaft of the needle a stoma holder runs along the shaft into the abdominal wall the patient is pushed and that the needle shaft with the end of the channel part attached to it is pulled through the stoma holder and thus through the abdominal wall of the patient and fastened on the outside of the patient's skin.

22. The method according to claim 21, characterized in that the free end of the channel part is connected to the shaft in that a thread is pierced through the end of the ureter, pulled through a hole in the shaft and knotted.

23. The method according to claim 21 or 22, characterized in that the abdominal wall while holding one

Protective cap is pierced.

24. The method according to any one of claims 21 to 23, characterized in that before the needle shaft is connected to the free end of the channel part, a needle tip which can be detached from the shaft is removed therefrom.

25. The method according to claim 24, characterized in that the needle tip is inserted into a non-rotationally symmetrical recess of the protective cap and is twisted off the shaft by means of the protective cap.

26. The method according to any one of claims 21-25, characterized in that a handle which projects radially beyond the diameter of the needle shaft is released from the needle shaft before the stoma holder is pushed onto the needle shaft.

27. The method according to any one of claims 21-26, characterized in that the free end of the channel part drawn through the stoma holder is sewn onto the stoma holder and / or the outside of the patient's skin.