Kit for producing a crosslinked gel for surrounding urinary calculi and/or fragments thereof

Abstract

Described is a kit for producing a crosslinked gel for surrounding urinary calculi and/or fragments thereof, more particularly kidney stones and/or fragments thereof, comprising a composition (A) comprising one or several cationically crosslinkable polymer(s), and a composition (B) comprising one or several crosslinking agent(s) for crosslinking the cationically crosslinkable polymer(s), wherein composition (A) and/or composition (B) additionally comprise(s) magnetizable particles or the kit additionally comprises a composition (C) that contains magnetizable particles. Upon contact of composition (A) with composition (B) in a region of the urinary tract, more particularly the kidney, that contains urinary calculi and/or fragments thereof, more particularly kidney stones and/or fragments thereof, a crosslinked gel is formed that partly or fully surrounds the urinary calculi and/or fragments thereof, more particularly kidney stones and/or fragments thereof, and that contains the magnetizable particles. The gel together with the urinary calculi and/or fragments thereof, more particularly kidney stones and/or fragments thereof, can then be removed from the body by using magnetic interactions.

Claims

1. A kit for producing a crosslinked gel for partly or fully surrounding urinary calculus fragments, the kit comprising: (a) a composition (A) comprising one or more cationically crosslinkable polymers, (b) a composition (B) comprising one or more crosslinking agents for crosslinking the cationically crosslinkable polymers, and (c) a magnetic fishing instrument configured to remove a magnetic urinary calculus-gel-composite by magnetic interaction between the magnetic fishing instrument and the magnetic urinary calculus-gel-composite, wherein at least one of composition (A) and composition (B) additionally comprise magnetizable particles or the kit additionally comprises a composition (C) that contains magnetizable particles, wherein the magnetic urinary calculus-gel-composite includes composition (A), composition (B), the magnetizable particles, and urinary calculus fragments.

2. The kit according to claim 1, wherein one or more of the cationically crosslinkable polymers of composition (A) are selected from the group consisting of polysaccharides, polysaccharides with deprotonated or deprotonatable functional groups, carboxy groups, polysaccharides from the group of polyuronides, polysaccharides from the group of alginates and pectins.

3. The kit according to claim 1, wherein one or more of the crosslinking agents of composition (B) are selected from the group consisting of divalent cations, trivalent cations, and iron and calcium ions.

4. The kit according to claim 1, wherein the composition (B) has an acidic pH-value in the range of 3.5 to 4.5.

5. The kit according to claim 1, wherein the magnetizable particles are particles comprising ferromagnetic elements.

6. The kit according to claim 5, wherein the ferromagnetic elements are at least one of iron, nickel cobalt, AlNiCo, SmCo, Nd.sub.2Fe.sub.14B, Ni.sub.80Fe.sub.20, NiFeCo, Fe.sub.3O.sub.4 and -Fe.sub.2O.sub.3.

7. The kit according to claim 1, wherein a total amount of the magnetizable particles with regard to the total weight of the compositions (A) or (B) or (C), respectively, that contains the magnetizable particles, is at least 0.1 wt.-%.

8. The kit according to claim 7, wherein the total amount of the magnetizable particles with regard to the total weight of composition (A) or (B) or (C), respectively, that contains the magnetizable particles is in a range of 0.1 to 70 wt.-%.

9. The kit according to claim 1, wherein the concentration of the crosslinking agents that are comprised in the composition (B) is at least 0.1 mol/L.

10. The kit according to claim 9, wherein the concentration of the crosslinking agents that are comprised in composition (B) is in a range of 0.1 to 3 mol/L.

11. The kit according to claim 1, wherein the composition (A), the composition (B), the composition (C) or a composition (D) comprises one or more substances for improving crosslinking of the cationically crosslinkable polymers.

12. The kit according to claim 11, wherein the one or more substances for improving crosslinking of the cationically crosslinkable polymers are amino acids.

13. The kit according to claim 1, wherein the composition (A), the composition (B), the composition (C) or a composition (D) comprised in the kit comprises one or more substances for improving or enabling the formation of covalent bonds between the crosslinked gel and the urinary calculus fragments that are to be partly or fully surrounded.

14. The kit according to claim 1, wherein the composition (A), the composition (B), the composition (C) or a composition (D) comprised in the kit comprises at least one or more further substances from the following list: dyes, contrast agents, preservatives and stabilizers.

15. The kit according to claim 1, wherein the kit additionally comprises one or more constituents selected from the group consisting of application catheter, syringe, mixing cup, mixing syringe and rinsing fluid.

16. The kit according to claim 1, wherein the crosslinked gel is for partly or fully surrounding kidney stone fragments.

17. The kit according to claim 1, wherein the magnetic fishing instrument is a magnetic retrieval basket.

Description

DETAILED DESCRIPTION

Example 1

Content of a Kit According to the Invention

(1) An exemplary kit according to the invention comprises the following constituents, sterile packed and ready for use: Composition (A): 10 mL of a 1 g/100 mL alginate solution in water Composition (B): 10 mL of a water-based chitosan solution (0.32 wt.-%, pH 6) with approx. 15 drops of an oxalic acid solution in water (1 M) as well as 1.5 mL of an aqueous FeCl.sub.3 solution (1 M) Composition (C): 1 mL of a particle suspension in water or in physiological buffer containing 4 to 40 mM iron (0.35 to 3.5 g per liter) (M. Geppert et al., Nanotechnology 22 (2011) 145101). 1 application catheter 1 syringe 1 mixing cup or mixing syringe 1 magnetic retrieval basket (made of PTFE-coated vanadium alloy).

Example 2

Application of a Kit According to the Invention

(2) An aditus to the lumen of the urinary tract (e.g., to the pelvicocaliceal system) is created either ureterorenoscopically (via the urethra, bladder or ureter) or percutaneously (via skin puncture at the flank). A specific port (a metal shaft if applicable) with an inner diameter of 3 to 9 mm is placed therein. An endoscope is inserted into the urinary tract lumen (e.g., into the pelvicocaliceal system) via the created aditus shaft, the surgical area is inspected and the urinary calculus or urinary calculi, respectively, is/are visualized. The urinary calculus or urinary calculi, respectively, is/are smashed by means of a holmium laser. The large and medium sized fragments are removed with the aid of a calculus catching instrument. Compositions (B) and (C) are mixed in a mixing syringe. Subsequently, a catheter is inserted via the endoscopy device (through the aditus) and the mixture of the compositions (B) and (C) according to example 1 is injected into the region of the urinary tract (e.g., into the pelvicocaliceal system) that contains the fragments of the smashed urinary calculus or calculi, respectively.

(3) The catheter is flushed with 0.9% NaCl solution and composition (A) according to example 1 is applied, whereby the gel formation occurs over the course of approx. 1 min. Then a grasping instrument is inserted via the surgical endoscope via the aditus shaft. The solidified gel is grasped in one piece or in several parts with the magnetic retrieval basket and removed from the body via extraction.