IP-2024-000024 - [2025] EWHC 492 (IPEC)

Wan is a Chinese utility model with the same inventor as the Patent. It discloses a surgical instrument with an irrigation and suction mechanism for washing and expelling fragments following lithotripsy. It is used in PCNL (see above), gallbladder surgery and cystolithotripsy (fragmentation of bladder stones) in women. Because it can be used percutaneously it has a ‘piercing sleeve tube’ and what was alternatively translated as a ‘piercing stylus’ or ‘piercing needle’. The alternatives made no difference so I will call it a ‘piercing stylus’.

Figure 5 shows an embodiment:

The piercing sleeve tube 3 is connected to a main tube 9 which has a side arm. The piercing stylus 6 is slightly longer than the combined length of the connected piercing sleeve tube and the main tube. In use, the sealing cap 7 is removed and the piercing stylus is inserted into the main/piercing tube. The stylus and tube are inserted into a pre-cut opening at the surgical site and moved into the patient until the distal end reaches to the stone or other target. The piercing stylus is then withdrawn from the tube, the sealing cap is replaced, and an endoscope is inserted into the tube via an aperture 8. Attachments to the endoscope are used to carry out irrigation and fragmentation at the target site. The side arm is connected to an external suction pump. The suction applied is controlled using a narrow slot in the side arm. Small fragments are removed from the fragmentation site by suction via the narrow space between the inside of the tube and the endoscope. Larger fragments can be removed if the endoscope is withdrawn, presumably to a point proximal to the side arm.

Two embodiments of the invention are described. The principal difference is that in embodiment 2 the piercing sleeve tube 3 and the main tube 9 are glued together, whereas in embodiment 1 they are connected via a connecting structure. The parties were agreed that an attempt to connect the sleeve tube to the main tube during the course of their use in the body would be dangerous and that embodiment 2 would be seen as the sole workable alternative.

The evidence of both experts was that Wan disclosed a sheath for an endoscope which could be used either for PCNL or for ureteroscopy.