WO2011096903A1

WO2011096903A1 - Catheter device used in the treatment of heart and large vein injuries

Info

Publication number: WO2011096903A1
Application number: PCT/TR2010/000019
Authority: WO
Inventors: Mahmut Tokur
Original assignee: Mahmut Tokur
Priority date: 2010-02-04
Filing date: 2010-02-04
Publication date: 2011-08-11

Abstract

This invention is designed for use for medical purposes. It is related to the catheter device (1) used in the treatment of penetrating injuries of heart and large veins. The device applied during repair of heart incision ensures more rapid and effective bleeding control through outer cap (8) and protective layer (7) on its body (2).

Description

DESCRIPTION

CATHETER DEVICE USED IN THE TREATMENT OF HEART AND

LARGE VEIN INJURIES

Technical Field

This invention is designed for use of medical purposes. It is related to the catheter device used in the treatment of penetrating injuries of the heart and large veins.

The device applied during repair of heart incision ensures more rapid and effective bleeding control through outer cap and protective layer on its body.

Previous Techniques

During the treatment of penetrating injuries of heart, sometimes foley catheter can be used. However this catheter may be pierced by a needle during the stitching of the wound. Piercing of the catheter causes difficulty of the treatment. The surgical treatments currently applied in relation to the issue are listed below.

I) To stopping the bleeding in a punctured heart:

The treatment of heart injuries is composed of several stages. The first stage is to replace the blood the patient has lost and to urgently close the hole where bleeding occurs. Then the permanent (definite) repair of the hole is performed.

After starting to give liquid and blood to the patient, pericardium should be opened with rapid thoracotomy or sternotomy and if any tamponade should be removed and the heart should be made visible. Then rapid first bleeding control (temporary bleeding control) and the simultaneous replacement of effective cardiac output increasing liquid should be performed and vital stabilization should be ensured. Then incision repair (repair of the hole in the heart) (permanent bleeding control) should be performed. 1) The first bleeding control (temporary bleeding control): it is the process that bleeding from the hole in the heart is stopped temporarily. It is performed by several methods.

a) Finger method: Stopping bleeding by putting the finger inside the heart through the hole in the heart.

b) Foley catheter method: Foley catheter is placed through the hole in the heart, balloon of the catheter is inflated so as to keep it inside the heart. Balloon is pulled outwards and it is endured to close the hole and thus bleeding is ensured to cease.

2) Repair of the incision (permanent bleeding control) (stitching the hole in the heart): it is possible in two ways.

a) The finger is not taken off from the hole in the heart (incision) and is moved forward and backward with control, and the heart muscle is tried to be stitched. b) After inflating the foley catheter placed through the hole in the heart, the heart muscle is stitched and incision repair is thus performed.

Incision repair (permanent bleeding control) can be directly performed without doing bleeding control with a finger or foley catheter (temporary bleeding control), however this intervention would significantly decrease the chance of success for the patient in shock.

All the three incision repair methods have their own difficulties in application.

1) Finger method: while performing incision repair before the finger is taken off from the incision, the needle can prick the finger and the gloves. During partial withdrawal-dislocation of hand for suturation, massive bleeding can occur again.

2) Foley catheter method: it can provide enough time for a successful first bleeding control and liquid resuscitation. However when the stage of incision repair comes, massive bleeding and volume loss due to the balloon being burst by the needle, panic and time loss occurring during the placement of the catheter once again increase mortality. In order to stop the bleeding in large incisions, it may be necessary to inflate the foley catheter excessively, and this may decrease the filling volume of the heart and cardiac output.

3) Direct suturation method: performing temporary bleeding control is not possible. Since permanent bleeding control is tried to be performed directly, there is no time to replace the blood and liquid lost by the patient, and even if the incision in the heart is repaired, liquid loss may lead to mortality.

II) Stopping bleeding in cases where there is multi-incision and additional organ injury:

When there is more than one incision in the heart, it is necessary that all the incisions are taken rapidly under control one by one with finger or foley catheter and this is a very difficult task.

When it is accompanied by injuries of large veins like Aorta, Pulmonary artery, VCS, and VCI, repair of cardiac incision on the one hand, and vascular injury on the other is a difficult process. This is also among the reasons of the increasing mortality.

In cases of both cardiac and coronary artery injuries by a single incision, as the coronary artery remains on the suturation line during primary suturation for the first urgent bleeding control it may cause intraoperative or postoperative myocardial ischemia. For this reason it is necessary to perform a bypass in large coronary incisions.

Valve or chorda tendinea incisions in heart injuries can be rarely observed. In such cases, after an urgent operation resulting with primary repair of heart incision, morbidity and mortality may occur.

As heart injuries are rapidly mortal they are traumas necessitating urgent surgical applications. However additional injuries omitted or not repaired as required during such urgent surgeries due to the fact that sufficient exploration and punctilious surgeries are not applied increase preoperative and postoperative mortality. In such complicated injuries, a rapid and punctilious surgery can only be performed with extracorporeal circulation. However sufficient time and surgical team can usually not be found for this. In the United States Patent documents numbered US 270 1559 and numbered US 395 2742 regarding the technique related to the issue, the apparatus used in the treatment of heart incision and in large vein injuries are mentioned. However in the documents included in the technique and in the current treatment applications, any treatment related to the issue, which is performed by ensuring more rapid and effective bleeding control is not mentioned.

Brief description of the invention

The purpose of this invention is to realize a catheter device which would ensure more rapid and effective bleeding control in the treatment of heart and large vein injuries and would facilitate incision repair.

Detailed description of the invention The catheter device created in order to reach the goals of this invention, which is used in the treatment of heart and large vein injuries, is shown in the annexed figures.

Among these figures;

Figure— 1 The appearance of the catheter device, which is the subject of the invention, used in the treatment of heart and large vein injuries.

The parts composing the catheter device, which is the subject of the invention, used in the treatment of heart and large vein injuries are shown with the below number in the annexed figures: 1. Device

2. Body

3. Balloon

4. Hole

5. First channel

6. Second channel

7. Layer

8. Outer cap

9. Clip

The catheter device, which is the subject of the invention, used in the treatment of heart and large vein injuries (1) is comprised of the following:

- a body in its most basic form (2)

- a balloon (3) placed in the heart and vein, on the body (2)

- at least one hole (4), on one side of the body (2), linked to the balloon (3), which can provide liquid entry to patient's body,

- first channel (5) on the other side of the body (2), providing liquid transfer to the hole (4)

- second channel (6), on and below the first channel (5), providing inflation and deflation of the balloon (3)

- at least one protective layer (7) in a one-piece structure with the balloon (3), which enlarges with the inflation of the balloon (3) and contracts with the deflation of the balloon (3), and which prevents the blowing up of the balloon (3) during treatment against pinpricks during suturation.

The catheter device (1), subject to the invention, used in the treatment of heart and large vein injuries comprises a movable outer cap (8) on the body (2).

The catheter device (1), subject to the invention, used in the treatment of heart and large vein injuries has a locking clip (9) providing the fixing of outer cap (8) when placed on the area wished to be intervened. During treatment with the invention, the incision in the heart is found and finger is put inside. The balloon (3) is placed inside the heart or the vein from the area of incision in the heart or vein next to the finger. The balloon (3) is inflated sufficiently so as to close the incision and pulled outwards and placed on the incision surface in the internal part. The outer cap (8) is placed on the incision from the outer surface and the clip (9) is closed thus compressing the heart muscle between the balloon (3) and the cap (8). By this way bleeding in the incision area is stopped. If necessary, direct liquid and blood replacement to the heart can be made through the first channel (5).

The invention can also be used in vascular injuries in the same way and incision repair can be performed afterwards or it can be prepared for extracorporeal circulation.

Around this fundamental concept, the catheter device (1), which is the subject of the invention, used in the treatment of heart and large vein injuries can be used in various applications to be developed, and the invention can not be limited to the instances explained here; it is fundamentally as is mentioned in the claims.

Claims

A catheter device (1) used in the treatment of heart and large vein injuries, comprising a body (2), a balloon (3) placed in the heart and vein on the body (2), at least one hole (4) on one side of the body (2) linked to the balloon (3) which can provide liquid entry to patient's body, a first channel (5) on the other side of the body (2) providing liquid transfer to the hole (4), a second channel (6) on top of and below the first channel (5) providing inflation and deflation of the balloon (3) and characterized with comprising at least one protective layer (7) in a one-piece structure with the balloon (3) which enlarges with the inflation of the balloon (3) contracts with the deflation of the balloon (3) and prevents the bursting of the balloon (3) during treatment against piercing by a needle during suturation.

The catheter device (1) used in the treatment of heart and large vein injuries as in Claim 1, characterized with comprising a movable outer cap (8) on the body (2), providing the total closing of the first bleedings of the incision.