Set / Kit for ultrasound-assisted formation of a temporary fluid depot (water depot) for flow blockage and controlled foam sclerotherapy in varicose veins and / or recurrent varicose veins

Abstract

(Main claim - Set / Kit) Set / Kit for ultrasound-assisted foam sclerotherapy of varicose veins and / or recurrent varicose veins, comprising a) a syringe for infiltration of a liquid, b) a first puncture / injection cannula for ultrasound-guided perivascular infiltration to create a fluid depot (“water depot”), c) an infiltration solution comprising isotonic saline solution (NaCl 0.9%) and / or tumescent solution, d) two syringes and a 3-way stopcock for producing a sclerosing foam from a sclerosing agent, wherein at least one of the two syringes is used for applying the sclerosing foam, e) a second puncture / injection cannula for ultrasound-guided injection of the sclerosing foam into a target vein segment, wherein the set / kit is intended for use under duplex / ultrasound control to effect a temporary local flow blockage by means of the water depot and thereby enable controlled intravascular distribution of the sclerosing foam in the target vein segment.

Description

1. Technical field

[0001] The invention relates to the ultrasound-assisted treatment of varicose veins and recurrent varicose veins by means of foam sclerotherapy and in particular a set / kit that technically enables the formation of a temporary fluid depot (“water depot”) for local flow blockage.

[0002] Definitions: VSM = great saphenous vein; VSP = small saphenous vein; VAA = anterior accessory vein; VAP = posterior accessory vein. 2. Background

[0003] Endovenous foam sclerotherapy carries a risk of uncontrolled foam distribution or leakage into deep veins, particularly in complex cases of recurrence. Furthermore, safe and reproducible foam application in the saphenofemoral junction / groin area and subfascially in perforating veins can be technically challenging. Task 3

[0004] The object of the invention is to provide a product (set / kit) that enables the formation of a local fluid depot under ultrasound control, which causes a temporary local flow blockage in order to support the controlled intravascular distribution of a sclerosing foam in the target segment and to limit the passage into deep veins. 4. Solution

[0005] The problem is solved by a set / kit according to claim 1. The set / kit comprises infiltration and application agents and is intended for use under duplex / ultrasound guidance. Infiltration creates a perivascular fluid reservoir ("water reservoir") that causes a temporary local flow blockage. Subsequently, a sclerosing foam can be applied in a controlled manner to the target segment. 5. Preferred embodiments / parameters (examples)

[0006] Preferably, the fluid depot is formed in the saphenofemoral junction / groin area with an infiltration volume of 10-25 ml. Alternatively, the fluid depot is preferably formed subfascially in the area of ​​a perforating vein with an infiltration volume of 5-10 ml. Polidocanol can be used as the sclerosing agent in concentrations of 1-3%. The temporary flow blockage can be maintained for 15-20 minutes until the depot is resorbed. The sclerosing foam can be prepared using a three-way stopcock and two syringes. 6. Brief description of the drawings Fig. Figure 1 schematically shows an application scenario in the saphenofemoral junction / groin area (1) with the deep vein (10) as a reference, a target segment (7), and the formation of a water depot (2) by infiltration using an infiltration cannula / agent (3) and infiltration solution (5). During the temporary local flow blockage, sclerosing foam (6) can be introduced into the target segment (7) via an application cannula / agent (4), thereby limiting its passage into the deep vein (10). Fig. Figure 2 schematically shows a subfascial application situation with fascia (8), perforating vein (9), target segment (7), water depot (2) and deep vein (10) as a reference, analogous to the Fig. 1. 7. Examples of implementation shown in the figures

[0007] Under duplex / ultrasound guidance, the infiltration cannula (3) is positioned perivascularly or subfascially, and the infiltration solution (5) is applied to create the water depot (2) as a temporary flow blockage. For example, 10 to 25 ml of 0.9% NaCl and / or tumescent solution can be infiltrated in the saphenofemoral junction / groin area (1); preferably 5 to 10 ml in the subfascial area of ​​a perforating vein (9). Subsequently, sclerosing foam (6), e.g., based on 1% to 3% polidocanol, can be injected in a controlled manner into the target segment (7) via the application cannula (4), while the water depot (2) limits the passage into deep veins (10). After resorption of the water depot (2), venous flow is restored. Reference symbol list 1 Crosse / Groin area (anatomical reference area) 2 Water reservoir (liquid reservoir) 3 Infiltration cannula / Infiltration medium 4 application cannula / application medium (foam) 5 Infiltration solution (NaCl / tumescent) 6 Sclerotic foam 7 Target vein / target segment 8 Fascia (subfascial space) 9 Perforating vein 10 Deep vein (reference) Introduction

[0008] This bibliography serves to present the known state of the art in the field of ultrasound-guided endovenous foam sclerotherapy. It identifies key scientific sources on which the present utility model application (set / kit for ultrasound-assisted foam sclerotherapy with temporary flow stoppage by the formation of a fluid reservoir ("water reservoir")) is based and which distinguishes it from the known technology. Literature / State of the art [1] Jia X. et al. (2007) Jia, X.; Mowatt, G.; Burr, J.M.; Cassar, K.; Cook, J.; Fraser, C. Systematic review of foam sclerotherapy for varicose veins. British Journal of Surgery, 94(8), 925-936. DOI: 10.1002 / bjs.5891 PMID: 17636511 A systematic review (69 studies) on the efficacy and safety of foam sclerotherapy reported a median rate of complete occlusion of treated veins of 87%, as well as rare serious adverse events (including DVT / PE < 1% as median values). [2] Tessari L. et al. (2001) Tessari, L.; Cavezzi, A.; Frullini, A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatologic Surgery, 27(1), 58-60. PMID: 11231246 (DOI in publisher databases: 10.1097 / 00042728-200101000-00017) Early clinical description of foam production using two syringes and a three-way stopcock (Tessari method) and its application to larger varicose veins. Serves as a basis for modern foam procedures and device / kit configurations. [3] Xu J. et al. (2016) Xu, J.; Wang, Y.-F.; Chen, A.-W.; Wang, T.; Liu, S.-H. A modified Tessari method for producing more foam. SpringerPlus, 5:129 (2016). DOI: 10.1186 / s40064-016-1769-5 PMID: 26933628 Describes a modification of the Tessari technique to increase the generated foam volume while maintaining comparable foam properties. A relevant comparison for further developments that control foam application through additional physical measures (e.g., temporary flow interruption). [4] Rabe E. et al. (2014) Rabe, E.; Breu, F.-X.; Cavezzi, A.; Smith, PC; Frullini, A.; including European guidelines for sclerotherapy in chronic venous disorders. Phlebology, 29(6), 338-354. DOI: 10.1177 / 0268355513483280 PMID: 23559590 European guideline with definitions, safety / quality requirements and recommendations for the use of liquid and foam sclerotherapy (including ultrasound guidance). [5] Ceulen RPM et al. (2010) Ceulen, RPM; Jagtman, E.A.; Summer, A.; Teule, GJJ; Schurink, GWH; Kemerink, GJ Blocking the saphenofemoral junction during ultrasound-guided foam sclerotherapy - assessment of a presumed safety-measure procedure. European Journal of Vascular and Endovascular Surgery, 40(6), 772-776. DOI: 10.1016 / j.ejvs.2010.08.010 PMID: 20926321 Investigates safety measures to limit foam overflow (compression / ligation of the SFJ). Shows: Overflow is reduced, but not prevented – comparison to alternative, locally limiting flow blockages. [6] Kakkos SK et al. (2006) Kakkos, SK; Bountouroglou, DG; Azzam, M.; Kalodiki, E.; Daskalopoulos, M.; Geroulakos, G. Effectiveness and safety of ultrasound-guided foam sclerotherapy for recurrent varicose veins: immediate results. Journal of Endovascular Therapy, 13(3), 357-364. DOI: 10.1583 / 05-1781.1 PMID: 16784324

[0009] Clinical data on UGFS in recurrent varicose veins; shows efficacy and influence of proximal reflux on outcome / side effects. Summary

[0010] The application builds on the state of the art of ultrasound-guided foam sclerotherapy and Tessari foam generation. It differs in that a temporary local flow stop is created by means of a perivascular fluid reservoir (“water reservoir”) to limit and control the distribution of the sclerosing foam in the target segment. QUOTES INCLUDED IN THE DESCRIPTION

[0000] This list of documents cited by the applicant was automatically generated and is included solely for the reader's convenience. The list is not part of the German patent or utility model application. The DPMA accepts no liability for any errors or omissions. Cited non-patent literature

[0000] Jia X et al. (2007) Jia, X.; Mowatt, G.; Burr, J.M.; Cassar, K.; Cook, J.; Fraser, C. Systematic review of foam sclerotherapy for varicose veins. British Journal of Surgery, 94(8), 925-936. DOI: 10.1002 / bjs.5891 PMID: 17636511

[0008] Tessari L. et al. (2001) Tessari, L.; Cavezzi, A.; Frullini, A. Preliminary experience with a new sclerosing foam in the treatment of varicose veins. Dermatologic Surgery, 27(1), 58-60. PMID: 11231246 (DOI in publisher databases: 10.1097 / 00042728-200101000-00017) Early clinical description of foam production using two syringes and a three-way stopcock (Tessari method) and its application to larger varicose veins. Serves as a basis for modern foam procedures and device / kit configurations

[0008] Xu J et al. (2016) Xu, J.; Wang, Y.-F.; Chen, A.-W.; Wang, T.; Liu, S.-H. A modified Tessari method for producing more foam. SpringerPlus, 5:129 (2016). DOI: 10.1186 / s40064-016-1769-5 PMID: 26933628

[0008] Rabe E. et al. (2014) Rabe, E.; Breu, F.-X.; Cavezzi, A.; Smith , PC ; Frullini , A. ; ua European Guidelines for Sclerotherapy in Chronic Venous Disorders. Phlebology, 29(6), 338-354. DOI: 10.1177 / 0268355513483280 PMID: 23559590

[0008] Ceulen RPM et al. (2010) Ceulen, RPM; Jagtman , EA ; Summer, A.; Teule, GJJ; Schurink , GWH ; Kemerink, GJ Blocking of the saphenofemoral junction during ultrasound-guided foam sclerotherapy. European Journal of Vascular and Endovascular Surgery, 40(6), 772-776. DOI: 10.1016 / j.ejvs.2010.08.010 PMID: 20926321

[0008] Kakkos SK et al. (2006) Kakkos, SK; Bountouroglou, DG; Azzam , M. ; Kalodic, E.; Daskalopoulos , M. ; Geroulakos, G. Effectiveness and safety of ultrasound-guided foam sclerotherapy for recurrent varicose veins: immediate results. Journal of Endovascular Therapy, 13(3), 357-364. DOI: 10.1583 / 05-1781.1 PMID: 16784324

[0008]

Claims

[1] (Main claim - Set / Kit) Set / Kit for ultrasound-assisted foam sclerotherapy of varicose veins and / or recurrent varicose veins, comprising a) a syringe for infiltration of a liquid, b) a first puncture / injection cannula for ultrasound-guided perivascular infiltration to create a fluid depot (“water depot”), c) an infiltration solution comprising isotonic saline solution (NaCl 0.9%) and / or tumescent solution, d) two syringes and a 3-way stopcock for producing a sclerosing foam from a sclerosing agent, wherein at least one of the two syringes is used for applying the sclerosing foam, e) a second puncture / injection cannula for ultrasound-guided injection of the sclerosing foam into a target vein segment, wherein the set / kit is intended for use under duplex / ultrasound control to effect a temporary local flow blockage by means of the water depot and thereby enable controlled intravascular distribution of the sclerosing foam in the target vein segment. [2] Set / Kit according to claim 1, wherein the syringe for infiltration comprises a 10 ml syringe. [3] Set / Kit according to claim 1 or 2, wherein the syringe used for applying the sclerosing foam comprises a 5 ml syringe. [4] Set / Kit according to any one of claims 1 to 3, wherein the first and / or the second puncture / injection cannula comprises a 20G × 70 mm cannula. [5] Set / Kit according to one of claims 1 to 4, wherein the water reservoir in the area of ​​the crosse can be formed with an infiltration volume of 10 to 25 ml. [6] Set / Kit according to one of claims 1 to 5, wherein the water depot can be formed subfascially in the area of ​​a perforating vein with an infiltration volume of 5 to 10 ml. [7] Set / Kit according to any one of claims 1 to 6, wherein the sclerosing agent comprises polidocanol in a concentration of 1% to 3%. [8] Set / Kit according to one of claims 1 to 7, wherein the sclerosing foam is produced from the two syringes using the 3-way stopcock. [9] (Use claim - product reference) Use of the set / kit according to any one of claims 1 to 8 for the treatment of (a) Recurrent varicose veins after previous operations on the great saphenous vein (VSM) or small saphenous vein (VSP), (b) isolated varicosity of the anterior accessory vein (VAA) and / or posterior accessory vein (PAP) and / or (c) Perforator insufficiency, wherein the water depot is intended to limit the passage of the sclerosing foam into deep veins.

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