Papillotome for percutaneous endoscopic gastrostomy

Abstract

A papillotome for percutaneous endoscopic gastrostomy including a front opening located in a free end region of a catheter and at the outlet of a first lumen, a rear opening further from a free end than the front opening and connects the first lumen to the outside, and a cutting wire located in the first lumen in an axially displaceable manner and extends through the front opening and the rear opening and is located on the outside between the front opening and the rear opening. When the cutting wire is tensioned, the free end region is deformed in an arc shape and the cutting wire forms a transversely extending cutting edge between the front opening and the rear opening. The front opening is arranged at a distance of at least 3 mm from the free end. A projection is formed between the free end and the front opening. A cutting tip is formed at the free end of the catheter. The cutting tip is connected to the cutting wire and forms the foremost end of the papillotome.

Claims

1. A papillotome for percutaneous endoscopic gastrostomy, comprising: a handle; an elongate flexible catheter attached to the handle which has a free end region with a free end and has at least one first lumen; a front opening which is located in the free end region and connects the first lumen to an outside of the catheter; a rear opening, which is located in the free end region of the catheter, and is further from the free end than the front opening and which connects the first lumen to the outside, wherein the front opening and the rear opening are arranged with the same orientation to the catheter; a cutting wire, which is located in an axially displaceable manner in the first lumen, extends through the front opening and the rear opening, and is located between the front opening and the rear opening on the outside, and which is fixed in the free end region and in the handle, wherein, when the handle is actuated, the cutting wire is tensioned, the free end region is deformed in an arc shape and the cutting wire forms a transversely extending cutting edge between the front opening and the rear opening, wherein the front opening is disposed at distance of at least 3 mm from the free end, and a projection is formed between the free end and the front opening, and a cutting tip is formed at the free end of the catheter that is connected to the cutting wire and forms the foremost end of the papillotome, wherein the cutting wire has a portion that is also located on the outside between the free end and the front opening, the portion of the cutting wire forms the cutting tip and the longitudinally extending cutting edge, and the portion of the cutting wire is disposed with the same orientation to the catheter as the front opening and the rear opening.

2. The papillotome according to claim 1, wherein the cutting wire forms the cutting tip.

3. The papillotome according to claim 1, wherein the free end is beveled, wherein a tip of the bevel is disposed with the same orientation to the catheter as the front opening and the rear opening.

4. The papillotome according to claim 1, wherein the front opening is disposed at a distance of maximally 15 mm from the free end.

5. The papillotome according to claim 4, wherein the front opening is disposed at a distance of 5 to 10 mm from the free end.

6. The papillotome according to claim 5, wherein the front opening is disposed at a distance of 4 to 7 mm from the free end.

7. The papillotome according to claim 1, wherein the catheter is attached to a stationary part of the handle and the cutting wire is attached to a movable part of the handle.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

(1) FIG. 1: shows a top view of a first exemplary embodiment of a papillotome with a bent free end region; both cutting edges can be seen,

(2) FIG. 2: shows an axial sectional view through the free end region of the catheter according to FIG. 1,

(3) FIG. 3: shows an axial sectional view similar to FIG. 1 through the free end region of the second exemplary embodiment,

(4) FIG. 4: shows a radial section along the line of cut IV-IV in FIG. 3,

(5) FIG. 5: shows a sectional view similar to FIG. 2 for a third exemplary embodiment, now with a rigid metal body that, in part, forms the projection,

(6) FIG. 6: shows an axial sectional view of a section of the free end region, now with a sphere at the free end of a first lumen; the rest is configured as in FIG. 5,

(7) FIG. 7: shows a schematic view of a section of the free end region similar to FIG. 5, now with a different metal body,

(8) FIG. 8: shows a perspective view of a PEG bumper,

(9) FIG. 9: shows a section through a stomach wall with an ingrown PEG bumper and a PEG catheter; a papillotome is inserted and ready to cut,

(10) FIG. 10: shows a side view of a first embodiment of a bougie, and

(11) FIG. 11: shows a side view of a second embodiment of a bougie.

DETAILED DESCRIPTION OF THE INVENTION

(12) The papillotome has a handle 2 with a stationary part 3 and a movable part 4, which here is configured as a slider that is displaceably guided on the stationary part 3. The stationary part 3 has an eyelet; two corresponding openings are provided on the movable part 4. A finger or a thumb can be inserted into all of them; the movable part can be displaced by moving. An HF terminal 6 is provided on the movable part 4. The movement is illustrated by the arrow 7. At the lower end of the stationary part 3, the latter transitions into a catheter 10. It is configured with two lumina, see FIG. 4. A second lumen 14 is accessible via a base 8. The latter ends with a screw thread. A guidewire 18 can be introduced here.

(13) The catheter 10 has a free end region. This extends from a foremost tip of the papillotome to a small extent beyond a rear opening 9. The front end region is the part of the catheter 10 which can be transferred from an extended into a bent state; the bent state is shown in FIG. 1.

(14) Details of the free end region are apparent from FIG. 2. A cutting wire 16 is displaceably guided in a first lumen 12. It is connected to the movable part 4 and the HF terminal 6. In the bent state as it is shown in FIG. 2, a tensile force acts on the cutting wire 16 in accordance with the arrow 13. The cutting wire 16 is stretched between the rear opening 9 and a front opening 11; there, it extends as straight as possible; it forms a transversely extending cutting edge 15. After passing the front opening 11, the cutting wire 16 runs in the first lumen 12 towards a free end 17; there, it exits the first lumen 12 and is bent around the end of the tube of the catheter 10 located there. It is routed along the outside. It reenters the first lumen 12 through a third opening 60. The third opening 60 is located between the front opening 11 and the rear opening 9. It is a very short distance away from the front opening 11. The distance is in the range of 1 to 8 mm. The third opening 60 is orientated to the catheter 10 as the two other openings 9, 11 are. After penetrating the third opening, the cutting wire 16 is inserted deeper into the first lumen 12 and possibly secured by an angled portion (as drawn).

(15) In a second embodiment according to the FIGS. 3 and 4, the free end is not cut off at an acute angle, as is apparent particularly from FIG. 2, but is cut off at the angle of 90°. The angle according to FIG. 2 can be between 10 and 80°; preferably, it is 45°. A guide wire 18 is introduced into the second lumen 14. The course of the cutting wire 16 is similar to the first exemplary embodiment, but with the following difference: After passing the front opening 11, the cutting wire 16 runs in the first lumen 12 towards the rear opening 11 and exits the first lumen 12 at the third opening 60 and is bent around the free end 17 of the tube of the catheter 10 and inserted into the first lumen 12. There, it has an arbitrary length. It is possibly secured by an angled portion. The latter can be hooked in with a short piece between the front opening 11 and the third opening 60 of the cutting wire 16 or the piece of the cutting wire 16 beyond the rear opening 9.

(16) The length of the projection 20 in the first exemplary embodiment is virtually equal to the length between an intersection of the longitudinally extending cutting edge 19 with the transversely extending cutting edge 15 and a cutting tip 22. To be exact, the projection 20 is slightly longer than the distance between the front opening 11 and the free end, because the cutting wire 16 is bent around the end of the tube of the catheter 10 and there adds to the length of the projection. At its direction-changing portion at the tip of the free end 17, the cutting wire 16 forms the cutting tip 22.

(17) In a third exemplary embodiment according to FIG. 5, the projection 22 is defined in part by a section of the catheter 10 protruding over the front opening 11 and in part by a metal piece 26, which is substantially configured as a needle. This metal piece 26 has an outer diameter that approximately corresponds to the clear diameter of the first lumen 12. The metal piece 26 is not flexible; it has the strength of, for example, a sewing needle. It is electrically connected to the cutting wire 16. The cutting wire is laid around the needle 26 and protrudes from the front opening 11 towards the outside; as in the previous exemplary embodiments, it extends to the rear opening 9 while forming a transversely extending cutting edge 15. The cutting tip 22 is now formed by the outside tip of the metal piece 26. The longitudinally extending cutting edge 19 now no longer extends over the entire length of the projection 22 but only over a part of the projection 22, for example maximally 80%, preferably maximally 60%.

(18) In a fourth exemplary embodiment according to FIG. 6, the metal piece 26 is formed by a sphere forming the cutting tip 22. It is electrically connected to the cutting wire 16. It is placed on the end of the second lumen 14 and attached there.

(19) In a fifth exemplary embodiment according to FIG. 7, the metal piece 26 is configured as a knife that cuts by itself. It is possible to selectively cut with the knife with or without an HF voltage applied to the knife. In the first case, both the transversely extending cutting edge 15 and the knife are cutting, because the cutting wire 16 and the metal piece 26 are electrically connected. In the second case, only the knife cuts, however in a purely mechanical manner. In addition, and independent from this, the metal piece 26 alone forms the projection 20. The front opening 11 coincides with the free end of the first lumen 12. The cutting wire 16 is electrically connected to the metal piece 26.

(20) FIG. 8 shows a commercially available PEG bumper 40. It has a passage 42. It is formed as a circular disc, Its thickness is denoted 44, 41 is its outer diameter, 43 is the diameter of the hole.

(21) FIG. 9 shows such a PEG bumper 40 ingrown into a stomach wall 50. The PEG bumper 40 is connected to a PEG catheter 46, It can be seen that the outlet of the PEG catheter 46 inside the stomach, which has previously been overgrown by mucosa, has been opened; this was done by means of the cutting tip 22. The papillotome is already shown in a position in which a cutting process can take place. The cutting tip 22 is in contact with the mucosa; the transversely extending cutting edge 15 rests on the inside of the mucosa. The inside of the stomach is located at the top of FIG. 9. If an HF voltage is now applied to the cutting wire 16 and the catheter 10 pulled in a downward direction, then a cutting process takes place. This is carried out until the transversely extending cutting edge 15 comes into contact with the PEG bumper 40. In the process, the cutting wire 16 can be pulled still further in the direction of the arrow 13 in order to support the cutting process with the longitudinally extending cutting edge 19. This can be continued until there is a contact with the circumference of the PEG bumper 40.

(22) Both cutting edges 15, 19 can thus be used separately and in a targeted manner. The transversely extending cutting edge 15 is controlled by a movement of the catheter 10 in the axial direction and a rotation of the catheter 10 about the axial direction. The longitudinally extending cutting edge 19 is controlled by pulling in the direction of the arrow 13 and releasing the cutting wire 16 in the opposite direction thereto.

(23) Two exemplary embodiments of so-called PEG bougies 30 are shown in FIGS. 10 and 11. In the push method, they serve for pushing the PEG bumper 40 and the PEG catheter 46 connected with it forward into the inside of the stomach, so that the PEG bumper 40 comes free. In the process, the PEG catheter 40 is shortened to the greatest extent possible.

(24) The bougie with the FIG. 10 has a forward section 32 and a main body 34; the forward section 32 has a constant diameter. It has a rounded tip 33. The tip is made from a soft material. It is connected flush with the main body 34 at a transition 36. There, the main body 34 has the same diameter as the forward section 32 and expands conically from the transition 36 in a downward direction.

(25) The PEG bougie is fitted, tip 33 first, into the PEG catheter 46. The forward section has a maximum length of 5 cm. The main body has a length of, for example, 5 cm to 12 cm. At one location 38, the bougie has an outer diameter that substantially corresponds to the inner diameter 43 minus, possibly, the inner diameter of the PEG catheter 46. The bougie 30 cannot be inserted further past this location 38 without a resistance arising. If it is inserted further, the PEG bumper 40 is taken along and pushed inwards, into the inside.

(26) Optionally, the bougie 30 has an internal bore for the guidewire 18.

(27) Preferably, the bougie 30 is manufactured from plastic; in the process, a coextrusion procedure can be carried out.

(28) FIG. 11 shows another embodiment of a bougie 30. The bougie 30 is designed to have a cylindrical main body 34 whose outer diameter is adapted by exactly the free inner diameter of the PEG catheter 46. The goal is to stiffen the PEG catheter 46 by the bougie 30 in such a way that, by means of the bougie 30 and the PEG catheter 46 together, a sufficiently large force can be exerted on the PEG bumper 40 to push the latter free. For this purpose, the PEG bougie 30 has a length that is greater than the rest of the length of the PEG catheter 46. Preferably, an axially adjustable stop 52, which supports the lower free end of the PEG catheter 46, is provided on the main body 34. The adjustability is illustrated by the double arrow 54.

(29) The bougie 30 is a rotating part; a longitudinal axis is shown in FIG. 10. Typical PEG bumpers have an outer diameter 41 of 15 mm to 18 mm. The inner diameter 43 is typically about 5 mm.

(30) Typically, the distance between the abdominal wall and the inside of the stomach is about 2 cm to 4 cm, depending on the patient. About 2 cm of the PEG catheter 46 are left to protrude from the abdominal wall. Thus, the cut PEG catheter 46 has a length of about 4 cm to 6 cm.

(31) A papillotome for percutaneous endoscopic gastrostomy has a front opening 11 located in a free end region of a catheter 10 and at the outlet of a first lumen 12, a rear opening 9, which is further from a free end 17 than the front opening 11 and that connects the first lumen 12 to the outside, and a cutting wire 16, which is located in an axially displaceable manner in the first lumen 12, which extends through the front opening 11 and the rear opening 9, which is located between the front opening 11 and the rear opening 9 on the outside, wherein, when the cutting wire 16 is tensioned, the free end region is deformed in an arc shape and the cutting wire 16 forms a transversely extending cutting edge 15 between the front opening 11 and the rear opening 9. The front opening 11 is disposed at a distance of at least 3 mm from the free end 17. A projection 20 is formed between the free end 17 and the front opening 11. A cutting tip 20 is formed at the free end 17 of the catheter 10 that is connected to the cutting wire 16 and forms the foremost end of the papillotome.

(32) While specific embodiments of the invention have been shown and described in detail to illustrate the inventive principles, it will be understood that the invention may be embodied otherwise without departing from such principles.