WO2015122859A1

WO2015122859A1 - System used in vein treatment

Info

Publication number: WO2015122859A1
Application number: PCT/TR2014/000198
Authority: WO
Inventors: Faik HASAR; Rasit DINC
Original assignee: FG GRUP SAGLIK INSAAT HARITA MIMARLIK MUHENDISLIK ELEKTRONIK SANAYI VE TICARET Ltd STI
Current assignee: FG GRUP SAGLIK INSAAT HARITA MIMARLIK MUHENDISLIK ELEKTRONIK SANAYI VE TICARET Ltd STI
Priority date: 2014-02-14
Filing date: 2014-06-06
Publication date: 2015-08-20
Anticipated expiration: 2016-08-14

Abstract

The present invention is related to a medical device and a medical process. It is particularly related to a procedure and vehicle that is used in preventing varicose veins, preventing the progress of varicose veins, to close aneurysms, to block arteries, to provide a method for said treatments and to treat the related vein malformation.

Description

DESCRIPTION

SYSTEM USED IN VEIN TREATMENT

TECHNICAL FIELD

PRIOR ART

The adhesion speed, its endurance, elasticity, rigidity and its absorbability by the body, and besides this, the mm diameter to which it is applicable to, and dosage calculation by distinguishing arteries or veins have not been carried in relation to cyanoacrylate glues used in prior studies. In the studies we have carried out, in Table 1 and Table 2, the required dosage amounts have been determined for application by taking into account the separation of arteries and veins and by taking millimetric diameters into account. The reason for this is that the vein structure differs from patient to patient. For example, a patient with varicose veins could have a vein diameter of 6mm and another could have a vein diameter of 9mm.

This is proof that patients cannot be given a fixed dose and that different dose applications must be carried out according to the specific vein diameters of said patients. The diameters proximal or distal to the vein can differ even in the same patient. The application must be different if the application is to be performed on a vein or an artery.

Besides these, it is crucial that the catheter that is to be used during application does not go into reaction with cyanoacrylate, that the application is not disrupted, that the catheter is not blocked and that the catheter dos not stick to the vein lumen. For this reason, during the delivery stage of cyanoacrylates, the most efficient tool to use is the PTFE catheter. PT FE generally is used in order to cover hydrophilic surfaces. Moreover the most important characteristic of PTFE is that it does not react with chemicals and it is not affected by high temperatures. Cyanoacrylate transferred into the vein goes into exothermic reaction with the vein and a certain amount of heat is manifested and polymerization starts. During this time, it is a critical factor that while the vein lumen reciprocally sticks to each other the remaining

l catheter between does not adhere. For this reason the PTFE catheter whose characteristics we have defined need to be produced from pure PTFE raw material.

BRIEF DESCRIPTION OF THE INVENTION

Surgical glues are presently known in the industry and are medically applied cyanoacryiic based glues and said glues are transferred to the area to be treated by means of different methods.

Methyl and ethyl groups show fast effects, and when they become rigid they are highly resistant but they are brittle and less elastic. They are preferred for fast results in surgical applications, and for their resistance when used in hard tissue such as bones.

Cyanoacrylates that comprise the butyl and octyl groups that form the subject of the invention show slower effects however when they become hard they still show elasticity features. At the same time they have inflammation effects on the endothelium. Especially in applications related to veins results that make them more preferable are obtained.

DETAILED DESCRIPTION OF THE INVENTION

The glue subject to the invention is used to prevent the formation of varicose veins/ to stop it from progressing to treat varicose veins and to seal vena saphena magna. Butyl based cyanoacryiic (N-Butyl-2-Cyanoacrylate) groups show more elasticity characteristics and as a result they are preferred in such applications. Dimethyl sulfoxide (DMSO) is used as solvent for the cyanoacrylates to adjust the viscosity. DMSO is preferred because of its biocompatibility.

In order to apply the procedure, cyanoacrylate application adjusted to a dose in compliance with the vein diameter based on Table 1, is carried out under ultrasound under the observation of a doctor at each 4cm from the starting point of the sapheno femoral junction to the end of said section.

Preferably Octyl-2-cyanoacrylate comprising and octyl group is used as it is elastic such that it fills the aneurysm (By taking Table 2 as reference) when treating aneurysms with glues that can occur in cerebral veins.

Moreover cyanoacrylate is also used in the following applications: • As an adhesive in inguinal hernia operations with surgical mesh support during either traditional or laparoscopic surgery,

• When stopping the hemorrhaging of liver sections (3cc),

• In order to stop hemorrhaging at the gallbladder base during traditional and laparoscopic surgery (2cc),

• In order to stop hemorrhaging and to repair the lesions or to stick parenchyma tissue in hemorrhagic lesions of the liver, kidneys, pancreas and the spleen (3 cc)

• When sealing and strengthening gastrointestinal anastomosis (2 cc)

• When stopping hemorrhaging in portocaval anastomosis (2 cc)

· Sealing appendicitis roots. (2 cc)

• As a sealer in the reconstruction of the rectovaginal septum (0,6 cc)

• When sealing anastomosis during the reconstruction of the gall bladder and the pancreas channel (1 cc)

• When treating lymphorrhagia that has occurred in the armpit and the inguinal hernia (1 cc)

• Generally when strengthening the aortic and vascular sutures (1 cc)

• When repairing the small lesions on the pericardium without using sutures (1 cc) ;

• As an adhesive to determine the adaptation period of arterial bypasses placed into the heart and to improve said bypasses, together with stopping hemorrhage and strengthening anastomosis during arterial bypass applications of the heart (0.5 cc for each artery)

• Re-covering the perianeurysmal tissue during ventricular aneurysm surgery (2 cc)

• Adhering the patch and strengthening sutures during left ventricle reduction (2 cc)

• As an adhesive in order to adhere the dissection plane in acute aorta dissections (2 cc)

• As an anti hemorrhagic when preventing hemorrhaging of the proximal and distal anastomosis in acute aorta dissections (1 cc)

• When adhering the patch that it to be placed in order to strengthen the dissected aorta (1 cc) • As an anti hemorrhagic of anastomosis during aorta valve surgery and especially when encountering atheromathous aorta. (1.5 cc)

• As an anti hemorrhagic and in order to strengthen sutures following aortic aneurysm repair. (2 cc)

· As an anti hemorrhagic adhesive following re-operations due to lacerations occurring in the ventricle during re-sternotomy or adhesions, (up to 3 cc)

• Providing aerostasis during lung resections, lobectomy, pneumo nectomy, bullectomy, volume reduction interventions and trachea bronchial resections, and when sealing off and strengthening sutures or staples in order to ensure improved running or mechanic closing (4 cc)

• In order to seal and¾rengthen vascular sutures during lung transplantations. (3 cc)

• In order to seal and strengthen sutures following trachea resections (2 cc)

• As an anti hemorrhagic during venous bleeding following dissection and extraction (such as decortications, adhesions, tumors, mediastinal tumors, and impaired pleural cavities) (3 cc)

• To seal off bronchial and bronchopleural fistulas (2 cc)

• In order to seal BOS fistulas following nasal-paranasal sinus and hypophysis operations (1 cc)

• In order to close Pharyngocutaneous fistulas; and sealing the saliva channels during nasal-pharynx cavity and oral cavity operations. (2 cc)

• Sealing off discharge occurring after ear operations or ear trauma. (1 cc)

• In order to treat seromas occurring after lymph node, and lateral neck and collarbone lymphorrhagia (2 cc).

• As an anti hemorrhagic to be used on the hemorrhagic surfaces of oral and pharynx cavities (1 cc)

Ethyl-2-Cyanoacrylate is preferred due to fast results in such applications.

• As a surface sealer in order to prevent BOS fistulas used together with haemostatic fabric and tampons that can be absorbed in order to protect the cerebral parenchyma during cranial, and spinal dural plastic surgery (2 cc) • As a sealer of the cavities that occur following the extraction of tumors in dural plastic surgeries (4 cc)

• As a sealer of dural lacerations occurring following hemilaminectomy surgeries. (2 cc)

• In order to seal off sella turcica, by trans sphenoidal route (2 cc)

· Adhering bone and bone-cartilage parts (4 cc)

• Adhering intercostals and cervical muscles (3 cc)

• Used in order to selectively adhere bone opercula (4 cc)

Methyl cyanoacrylate is preferred as it is resistant and shows fast results.

• Treating myoma in gynecology(2 cc)

• As an anti hemorrhagic and adhesive used during vaginal and perineal plastic surgeries (2 cc)

• In order to stop vaginal bleeding following hysterectomy and urethral cystopecsy (2 cc)

• Sealing off and stopping venous hemorrhaging (2 cc)

• As a sealer and anti hemorrhagic in reconstructive surgery following extirpative oncological operations (3 cc)

Octyl-2-Cyanoacrylate is preferred due to elasticity.

• Sealing sutures made to prevent urinary incontinence. (1 cc)

• Adhering and stopping hemorrhaging following kidney transplants and nephrolithotomy operations (2 cc)

· As a sealer and anti hemorrhagic of kidney lacerations and hemorrhagic lesions (2 cc)

• Treating urinary fistulas (1 cc)

• Sealing off the excretion channel during partial nephrectomy operations and stopping hemorrhaging (2 cc) Lymphorrhagia treatment following surgery (2 cc)

Octyl-2-Cyanoacrylate is preferred due to elasticity.

· In order to endoscopically treat the esophagus, esophagotrachial, gastric, gastro intestinal, duodenal and pancreatic fistulas (2 cc)

• In order to endoscopically treat gastric, duodenal and peptic ulcers (1.5 cc)

• In order to endoscopically treat esophagus, gastric and duodenal varicose (2 cc)

N-Butyl-2-Cyanoacrylate group is preferred due to its fast effects and elasticity.

• N-Butyl-2-Cyanoacrylate is preferred as it has fast effects and shows elasticity in arterial and venous embolization. (2 cc)

Although there is an application difference in all product groups, the system features are based on the same principle. According to application the delivery catheter and the introducer sheath lengths and diameters change although the material they are formed of does not change. The selection of materials to be used during procedures is important as it should not react to the cyanoacrylic agent. At the same time these agents also need to be complaint for sterilization.

a. Introducer Sheath (introducer catheter) selection: It is not important if the introducer sheath is reactive to the cyanoacrylic agent or not as it does not have contact with said agent. However it is important that it is compliant with blood and the fact that it can be moved forward as it will be used inside the vein lumen.

Polyethylene raw material has been used to achieve this. The most suitable density in terms of rigidity has been found.

Connector parts have been attached to the ends of the produced sheaths so that they can be attached suitably to the other system parts.

Finally in order to provide practical usage, each cm on the sheath has been marked. b. Delivery catheter: This is the system that shall carry the cyanoacrylic agent to the area of application. It is important that this catheter does not react to the cyanoacrylic agent. For this reason the usage of a 3F (3 French) diameter PTFE catheter has been preferred.

Before deciding on using PTFE, polyurethane and pebax alternatives have been chosen, however due to their reactive characteristics suitable results have not been obtained.

c. Polymer container: Is a system that shall store the cyanoacrylic agent. It is important that it does not show reaction to the cyanoacrylic agent. At the same time it should allow EO sterilization and should protect the cyanoacrylic polymer from reaction. For this reason container produced from HDPE have been preferred.

LDPE and PU and PA materials have been tried but the results were not healthy.

Table 1.

*Viscosity measurements have been taken in room temperature

Table 2.

Application is carried out in 1 cm gaps in the arterial system

Single dose, double dose, and triple doses have been included in Table 1 and Table 2.

EXAMPLES

MiYOM TEDAVISi

During myoma embolism the aim is to prevent the growth of the myoma by blocking the artery that feeds said myoma and as a result killing the myoma (necrosis). Cyanoacrylate and myoma arteries are blocked during myoma embolization with cyanoacrylate. The amount of cyanoacrylate to be used shall be determined after checking from the table according to the diameter of the artery feeding the myoma. For example if the artery diameter is 2mm, SINGLE DOSE will be applied and a single dose in each 1cm with a catheter is applied. If the artery diameter is 9mm, two doses will be applied and the catheter will be pulled back 1cm and the process will be continued.

VARICOSE TREATMENT

The aim during varicose embolization is to block and seal off the vein that is causing the varicose. When the leakage is blocked the varicose is also eliminated. Insertion is carried out from the femoral vein within the angio unit, and the vein that is causing the varicose is reached. Cyanoacrylate is given at doses mentioned in Table to according to the diameter of the vein causing the varicose using a 3F PTFE catheter and embolization procedure is carried out. However the application to the vein must be performed at intervals of 4cm's.

ANEURYSM The aim during aneurysm embolization is to block and seal off the artery sections that are expanding. Generally these procedures are carried out with stands or coils and they are effective, however they still entail leaving a foreign object into the body. The usage of cyanoacrylate in aneurysm embolization is a different approach. Insertion is carried out into the femoral artery during angio and the aneurysm area is reached. A PTFE catheter is sent into the aneurysm and the area is filled with cyanoacrylate. In time, said cyanoacrylate is absorbed by the body and as a result there is no need for a foreign object to be left inside the body when treating said aneurysm. The dose is adjusted for aneurysms by taking Table 1 as basis in accordance with the related aneurysm. The aneurysm that is filled with cyanoacrylate is separated from the related vein. The vein is then healed. The aneurysm that has separated will be absorbed by the body.

Claims

1. A system used in vein treatment, characterized in that it comprises:

a) An introducer sheath that provides movement inside the vein lumen, and b) A delivery catheter formed of PTFE that shall carry the pre-determined dose of cyanoacrylate, according to the diameter of the vein, to the area of procedure.

2. A system according to claim 1, characterized in that the introducer sheath is polyethylene.

3. A system according to claim 1, characterized in that the introducer sheath is marked at every centimeter.

4. A system according to claim 1, characterized in that the delivery catheter has a 3 French diameter.

5. A system according to claim 1, characterized in that it carries the pre-determined cyanoacrylate dose to the vein and is applied at each 1 cm according to the diameter of the vein.

6. A system according to claim 1, characterized in that it carries the pre-determined cyanoacrylate dose to the vein and is applied at each 4 cm according to the diameter of the vein.

7. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is between l-3mm, an amount of N-butyl cyanoacrylate 0.02 cc is applied as a single dose having a viscosity of 5000 centipoise.

8. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is between 4-5mm, an amount of N-butyl cyanoacrylate 0.03 cc is applied as a single dose having a viscosity of 5000 centipoise.

9. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is 6mm, an amount of N-butyl cyanoacrylate 0.06 cc is applied as a single dose having a viscosity of 5000 centipoise.

10. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is between 7-8mm, an amount of N-butyl cyanoacrylate 0.08 cc is applied as a single dose having a viscosity of 5000 centipoise.

11. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is between 9-10 mm, an amount of N-butyl cyanoacrylate 0.01 cc is applied as a double dose having a viscosity of 1000 centipoise.

12. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is 11 mm, an amount of N-butyl cyanoacrylate 0.15 cc is applied as a double dose having a viscosity of 1000 centipoise.

13. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is between 12-13 mm, an amount of N-butyl cyanoacrylate 0.17 cc is applied as a double dose having a viscosity of 1000 centipoise.

14. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is between 14-15 mm, an amount of N-butyl cyanoacrylate 0.2 cc is applied as a double dose having a viscosity of 100 centipoise.

15. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is between 16-17 mm, an amount of N-butyl cyanoacrylate 0.3 cc is applied as a triple dose having a viscosity of 100 centipoise.

16. A system according to claim 5 or 6, characterized in that when the vein diameter in venous applications is between 18-20 mm, an amount of N-butyl cyanoacrylate 0.4 cc is applied as a triple dose having a viscosity of 100 centipoise.

17. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is 1 mm, an amount of N-butyl cyanoacrylate 0.1 cc is applied as a single dose having a viscosity of 5000 centipoise.

18. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is 2 mm, an amount of N-butyl cyanoacrylate 0.2 cc is applied as a single dose having a viscosity of 5000 centipoise.

19. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is 3mm, an amount of N-butyl cyanoacrylate 0.4 cc is applied as a single dose having a viscosity of 5000 centipoise

20. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is 4 mm, an amount of N-butyl cyanoacrylate 0.8 cc is applied as a single dose having a viscosity of 5000 centipoise.

21. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is between 5-6 mm, an amount of N-butyl cyanoacrylate 0.9 cc is applied as a single dose having a viscosity of 5000 centipoise.

22. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is between 7-8 mm, an amount of N-butyl cyanoacrylate 0.1 cc is applied as a single dose having a viscosity of 5000 centipoise.

23. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is 9mm, an amount of N-butyl cyanoacrylate 0.15 cc is applied as a double dose having a viscosity of 1000 centipoise.

24. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is 10 mm, an amount of N-butyl cyanoacrylate 0.19 cc is applied as a double dose having a viscosity of 1000 centipoise.

25. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is 11 mm, an amount of N-butyl cyanoacrylate 0.25 cc is applied as a double dose having a viscosity of 1000 centipoise

26. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is between 12-13 mm, an amount of N-butyl cyanoacrylate 0.3 cc is applied as a double dose having a viscosity of 1000 centipoise

27. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is 14 mm, an amount of N-butyl cyanoacrylate 0.3 cc is applied as a triple dose having a viscosity of 100 centipoise

28. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is between 15-19mm, an amount of N-butyl cyanoacrylate 0.4 cc is applied as a triple dose having a viscosity of 100 centipoise.

29. A system according to claim 5 or 6, characterized in that when the vein diameter in arterial applications is 20mm, an amount of N-butyl cyanoacrylate 0.5 cc is applied as a triple dose having a viscosity of 100 centipoise