WO2017089843A1

WO2017089843A1 - Clossure device of radial artery with simultaneous compression of ulnar artery (ultra)

Info

Publication number: WO2017089843A1
Application number: PCT/GR2016/000058
Authority: WO
Inventors: Michail KOUTOUZIS
Original assignee: Koutouzis Michail
Priority date: 2015-11-27
Filing date: 2016-10-27
Publication date: 2017-06-01
Also published as: GR20150100514A

Abstract

The ULTRA device is a compression device for the occlusion of the radial artery with simultaneously compression of the ulnar artery, aiming both to achieve haemostasis at the puncture site and to prevent the obstruction of the radial artery. It consists of a flexible plastic splint, two elastic supporting belts for the support of the splint and two wrist bands apparatus with supplementary segments each consisting of a pressing system. Its functions includes the following steps: A. The placement and fastening of the ULTRA device on the wrist. B. Initially clasping the flexible belt to compress the pressing part (or device) for the radial artery. C. Clasping the flexible belt to compress the pressing part (or device) for the ulnar artery. D. Progressive looseness of the radial artery's flexible belt in order to ensure distal blood flow without bleeding. E. Removal of the compression of ulnar artery one hour after its launch. F. Achieving hemostasis. G. Removal of ULTRA device from the wrist.

Description

CLOSSURE DEVICE OF RADIAL ARTERY WITH SIMULTANEOUS COMPRESSION Of ULNAR ARTERY (ULTRA)

The invention consists of an externa! radial artery occlusion device with an adjunct compression system for the ulnar artery (applied for a shorter period of time), used for haemostasis immediately after the left heart catheterization. The system is composed of a splint of synthetic plastic material with a proximaf and distal supporting belt and two elastic bandages which carry a plastic or siiicone spot. The bandages are connected to the splint with a releasable but secured adhesive tape (Velcro).

Similar radiat artery occlusion devices are already used since several years and they have been certified by large randomized trials and observational studies in ciinical practice. These devices consist of a plastic or fabric elastic wrist bandage with a Velcro closure. The occlusion of the radial artery is achieved either with a balloon filled with lQ-20cc of air using a syringe., or with a simple closure device or a screw closure device with a silicone edge to press the radial artery.

Specifically, these closure devices have been used to compress externally the blood vessels in various body parts aiming to reduce or block the blood flow through these, in order to achieve hemostasia. Such devices are generally used in clinical procedures, e.g. coronary artery catheterization, using catheters which are inserted through sheaths which are placed in peripheral arteries puncture sites. Such puncture points are usually arteries under the patient's skin surface, e.g. a femoral artery in the groin or radial artery in the wrist area. At the end of these procedures, when catheters and sheaths are withdrawn, these devices are used to com press externally the blood vessels in order to achieve hemostasis at the puncture site. It is well known that when compression is applied externally on the body surface, right above a target vessel, the blood flow is decelerated so that clot is formated and normal hemostasis is finally achieved. It is very important to ensure:

i. Visual and physical access to the puncture site

ii. Regulated compression over a target vessel so that the arterial or the venous blood flow in the limb (for example a hand) is preserved

iii. Quick and easy device removal from the patient

iv. Distal blood flow through adjacent blood vessels; for example, peripheral blood flow through the ulnar artery and the venous blood return from the hand, while compression on the target vessel is applied

The term "patent hemostasis" proposed and first described by Samir Pancholy, MD in the PROPHET study in 2007 in order to reduce the incidence of radial artery occlusion. This method maintains the blood flow through the radial artery while external compression is applied, in order to achieve hemostasis. He proved that maintaining artery patency during the compression leads to reduced incidence of radial artery occlusion. Recently, Bernat I. et al. in their study "Efficacy and safety of transient ulnar artery compression to recanalize acute radial artery occlusion after transradial catheterization" American Journal of Cardiology, 2011 June 1; 107 (11): 1698-701. doi: 10.1016 / j.amjcard.2011.01.056. Epub 2011 Mar, showed an improved recanalization rates of the occluded radial arteries with ulnar artery compression.

The standard adjustable device called TR Band manufactured from Terumo company (US Pat. No. 7,498,47), consists of a wrist strap that applies compression through two inflatable air chambers; one of them is the basis for directly compression of the radial artery. With a syringe connected via a pipe with the two chambers, air is imported and compression is applied over the puncture site in order to achieve hemostasis. The air can be gradually withdrawn and this allows the blood to flow through the radial artery without bleeding at the puncture site. An additional feature of the TR Band is the ability to automatically reduce the volume of air when the radial compression is excessive.

Besides TR Band there are several other closure devices. The RadAR device (abandoned U.S. patent application Ser. No. 61 / 198,956) also uses adjustable compression; however, is achieved by mechanical external compression rather than with air. Another device is HemoBand (US Pat. No.5,269,803) which consists of a strap, that surrounds the forearm and a compression cushion which is applied above the vessel, in order to prevent bleeding. All these previously mentioned closure devices are used in clinical practice in order to achieve radial artery hemostasis. The radial access is a world wide growing method, since it has clear advantages over the conventional femoral access, especially concerning bleedings and the preference of patients, because of the immediate mobilization and the ability of same day discharge. On the other hand, the most common complication of radial access is the radial artery occlusion, in a rate that varies from 1-10% according to several studies. Although there are devices available for compressing the radial artery, no devices are yet commercially available, that compress simultaneously the radial and the ulnar artery. This led to the need of producing a device, based on the previous ones, which will reduce the occlusion of the radial artery.

Previous studies have shown that if ulnar artery is compressed immediately after the occlusion of the radial artery, a sufficiently large proportion of the latest will be revasculirized. Both ulnar and radial arteries are continuations of the brachial artery. By pressing the ulnar artery, the velocity of blood flow to the radial artery is increased, prohibiting thombus formation and leading to better patency of the radial artery. The device of simultaneous closure of the radial and ulnar artery presented herein (hereafter called ULTRA) has features that allow the adequate adjustable compression (at the discretion of the user), that is applied over radial and ulnar artery in order to maintain the blood flow and hemostasis. For example, the device can be used for simultaneous partial or complete blockage of blood flow, by adjusting the compression that increases gradually in order to achieve the hemostasis, while the venous blood return from the hand is allowed. The idea behind this device has gained awards of best of the best abstract (SCAI Congress 2016) and best 20 abstracts (TCT Congress 2016). For the implementation of the adjusted compression a) Velcro strip that can be amended and b) a pressing device is needed. Furthermore, the plastic splint is used indirectly to maintain the correct position of the hand during compression modification in order to be connected - disconnected quickly and safely from patient's wrist.

The ULTRA device consists of biosynthetic materials which can be assembled, packaged and sterilized for multiple use applications. Alternatively, the splint and the wristband apparatus can be provided in a partially or fully assembled sterile form.

The splint consists of a relatively flexible plate (1) to provide support and assist in pressure distribution on the back of the wrist, so that the blood flow in the vessels is not hindered. The splint is used to place the wrist in a fixed position with slightly bent. The material from which the base of the splint consists is plastic, flexible and hypo allergic, to avoid both a possible allergic reaction and potential pain in the forearm by a rigid plastic material. There are also two flexible and elastic (proximal and distal) supporting belts (2) which are easily placed and adapted to the hand.

Each one of two wrist bands apparatus of the present device includes: a flexible belt (3) with two edges, a part for the fastening of the strip circumferentially around the wrist and the strip that preferably includes a part in "hook - Loop" form as e.g. Vetera (the loop material is placed on one end and the hook material on the opposite end of the belt) and a plastic or silicone part for pressure. The belt consists of a flexible, elastic, synthetic material, i.e. vinyl, polyvinyl chloride, polyethylene, polyurethane, nylon, fabric or other similar material. In the pressing segment (4), a rigid substrate (5) is applied between the upper surface of the segment and the underside, like a belt, to provide support. Both wrist bands can be independently applied in different levels of the wrist, providing hemostasis according to exact puncture site and can be adjusted over the arteries, since the distance between the radial and the ulnar artery is not the same in all wrists. For the correct fitting to the hand, the length of each belt will vary between 8.0 and 14.0 inches in length and between 0.75 "and 2.25" in width.

When the belt is clasped for the adjustment of the pressing segment, the puncture site is compressed. The belt is secured around the wrist strap and the pressing part is pressing in the vertical direction towards the wrist. Simultaneously, the rigid substrate is been pressed firmly in the upward direction and causes compression downwards on the soft tissue of the wrist and so on the structures of the immediately underlying soft tissue, i.e. the ulnar and radial artery. Such compression lead to flattening or narrowing of the lumen of the arteries beneath depending on the level of compression applied that varies from complete occlusion to various levels of patency (patent hemostasis). The pressing device of the radial artery aims to achieve hemostasis, while the one of the ulnar artery aims to reduce the blood flow distally and simultaneously to increase the blood flow through the radial artery. The release of the belt causes the exact opposite effects.

The present invention achieves its objectives through the methods described above. It is understood that the present invention is not limited to the method or the detail of the construction (construction, material, application or use described and illustrated herein)^, indeed, any suitable variation of manufacture, use, or application is considered as an alternative embodiment, thus within the spirit and scope of the invention. Accordingly, while the present invention has been demonstrated and described with reference to previous inventive closure devices, it becomes apparent to the specialists that modifications in the form and the details can be made without deviating from the spirit and scope of the invention as defined in the claims.

Claims

1. The simultaneous occlusion of radial and ulnar artery system (ULTRA) after the puncture for catheterization of the radial artery, consists of a flexible plastic splint, two elastic supporting belts for the support of the splint and two independent wrist bands with supplementary segments consisting the pressing system apparatus, so they compression can be applied exactly over the forearm arteries in all wrist sizes.

2. The wrist bands apparatus for achieving haemostasis in the puncture site of the radial artery as indicated in claim 1 consists of a flexible belt with two edges for the fastening of the strip circumferentially around the wrist, the strip and a pressing device for applying adjustable external pressure in order to achieve haemostasis.

3. The wrist band apparatus, which is used for simultaneously compression of the ulnar artery in the wrist, as explained in claim 1, consist of a flexible belt having two ends, a segment that stabilizes the wrist and the splint, and a pressing device for applying adjustable external pressure for finite time.

4. The part that secures the device of claims 2 and 3, is comprised of a "hook" material placed at one end of the belt and a "loop" one which is placed at the opposite end of the belt (Velcro).

5. The flexible belt of claims 2 and 3 is formed as a structure of multiple segments.

6. The compress material of claims 2 and 3 further is made of a rigid material connected with a plastic or silicone material to achieve compression or decompression of the target vessel.

7. The splint of claim 1, consists of a hypo allergic flexible plastic or similar material with incorporated belts for its fixation on the hand.

8. The splint support belts of claim 1 consist of a flexible, resilient synthetic material for its adaptation and easy placement on the hand.