Abstract
BackgroundDuring surgery, controlled haemostasis to prevent blood loss is vital for a successful outcome. It can be difficult to ligate vessels located deep in the abdomen. A device that is easy to use and enables secure ligatures could be beneficial. Cable ties made of nylon have been used for ligation but the non-resorbable material caused tissue reactions. The objective of this study was to use a resorbable material to construct a device with a self-locking mechanism and to test its mechanical strength and ligation efficiency.MethodsThe device was manufactured by injection moulding of polydioxanone, a resorbable polymer used for suture materials. Polydioxanone with inherent viscosities of 1.9 dL/g and 1.3 dL/g were tested. The device consisted of a perforated flexible band which could be pulled through a case with a locking mechanism. After a first version of the device had been tested, some improvements were made. The locking case was downsized, corners were rounded off, the band was made thicker and the mould was redesigned to produce longer devices. Tensile tests were performed with the second version.The first version of the device was used to ligate the ovarian pedicle in a euthanized dog and to test echogenicity of the device with ultrasound. Compression of vessels of the ovarian pedicle was examined by histology. Both versions of the device were tested for haemostasis of and tissue grip on renal arteries in six anaesthetised pigs.ResultsThe tensile strength of the flexible band of the devices with inherent viscosity of 1.9 dL/g was 50.1 ± 5.5 N (range 35.2-62.9 N, n = 11) and the devices with inherent viscosity of 1.3 dL/g had a tensile strength of 39.8 ± 8.1 N (range 18.6-54.2 N, n = 11). Injection moulding of the polymer with lower inherent viscosity resulted in a longer flow distance.Both versions of the device had an effective tissue grip and complete haemostasis of renal arteries was verified. The device attached to the ovarian pedicle could be seen with ultrasound, and vessel compression and occlusion were verified by histology.ConclusionsTests of functionality of the device showed complete haemostasis and good tissue grip. Devices with a band of sufficient length were easily applied and tightened in tissue.
Highlights
During surgery, controlled haemostasis to prevent blood loss is vital for a successful outcome
Injection moulding of polydioxanone The mould for version one resulted in short devices whereas the modified design of mould for version two improved manufacturing results
The polymer with an inherent viscosity of 1.9 dL/g resulted in a shorter flow distance in the moulds and made the flexible band too short for optimal handling during surgery
Summary
During surgery, controlled haemostasis to prevent blood loss is vital for a successful outcome. A device that is easy to use and enables secure ligatures could be beneficial. Cable ties made of nylon have been used for ligation but the non-resorbable material caused tissue reactions. The use of non-resorbable nylon cable ties for haemostasis in soft tissue surgery has been described [2,3,4,5,6,7,8]. Non-resorbable materials used for ligation purposes and left permanently in tissue, can cause complications such as fistulas and granulomas [9,10,11]. If a device, based on the construction of a self-locking loop, could be made of a resorbable material it could minimize the risk of adverse tissue reactions but potentially maintain the advantages experienced with traditional cable ties
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