DEVICE FOR CAESAREAN DELIVERY

Abstract

Blood-flow reduction device (1) for Caesarean delivery operations, comprising a frame (2) defining internally an area (3) inside which a cut may be made along an incision line (L) on the uterus of a patient giving delivery. The blood-flow reduction device comprises at least one gripping means (4) for exerting a pressure on the patient giving birth using the frame (2) and reducing the blood flow in the area (3).

Claims

1. Blood-flow reduction device for Caesarean delivery operations, comprising: a frame, defining internally an area inside which a cut may be made along a line for incision of a uterus of a patient giving birth; and at least one gripping means for exerting a pressure with the frame on the patient giving birth, wherein the frame is a closed ring and encloses said area so that the pressure of the frame on the patient giving birth reduces blood flow within the closed area inside the frame as a result of the cut.

2. Device according to claim 1, wherein the frame is associated with an aspirator designed to remove from the area liquid blood which is dispersed as a result of cutting of blood vessels along the incision line.

3. Device according to claim 2, wherein the frame has a C-shaped cross-section with an opening directed towards a centre of the frame.

4. Device according to claim 2, wherein the frame is provided with a connection for the aspirator.

5. Device according to claim 4, wherein the ring can be opened.

6. Device according to claim 1, wherein the gripping means comprises at least one first handle with a proximal connection piece close to the frame and a distal connection piece.

7. Device according to claim 6, wherein the at least one first handle forms an aspiration duct of an aspirator, and the proximal connection piece of said first handle emerges inside the area towards a centre of the frame.

8. Device according to claim 6, wherein the gripping means comprises a second handle having a respective proximal connection piece close to the frame, situated opposite the proximal connection piece of the first handle, and a distal connection piece.

9. Device according to claim 8, wherein the frame has an elongated, oval, quadrangular or polygonal form, and said distal connection pieces are situated on opposite portions of the frame arranged close together.

10. Device according to claim 6, wherein said at least one first handle is formed as one piece with the frame.

11. Device according to claim 8, wherein the first handle and the second handle are formed as one piece with the frame.

12. Device according to claim 11, wherein at least the second handle can be removed from the frame.

13. Device according to claim 8, wherein the first and second handles are aligned along the incision line and are orthogonal to the area.

14. Device according to claim 8, wherein the first and second handles are arranged spaced from each other on the frame at an angle greater than 90° and preferably equal to 120°.

15. Device according to claim 1, wherein the frame comprises a surface lining intended to make pressing contact with the uterus, said lining being biocompatible and sterilizable.

16. Device according to claim 1, wherein the frame does not have sharp corners.

Description

BRIEF DESCRIPTION OF THE DRAWINGS

[0030] FIG. 1 shows a schematic view of a patient giving birth, a newly born baby and the hand of a surgeon in the cutting area of a Caesarean delivery.

[0031] FIG. 2 shows a schematic view of the cutting line of a Caesarean delivery.

[0032] FIG. 3 shows a schematic view of a blood-flow reduction device for a Caesarean delivery, according to the present invention.

[0033] FIG. 4 shows a schematic view of a blood-flow reduction device for a Caesarean delivery, according to a variation of embodiment of the present invention.

DETAILED DESCRIPTION

[0034] With reference to the attached figures, examples of embodiment of a blood-flow reduction device for Caesarean delivery operations according to the present invention are described below.

[0035] The blood-flow reduction device is intended to be used during execution of the incision on the patient giving birth, as schematically shown in FIG. 3, along a line L which is normally horizontal or—more rarely—longitudinal (head-to-foot direction), passing through the skin, and at a deeper level, through the muscle fibre, peritoneum and uterus.

[0036] In particular, the blood-flow reduction device is intended to be applied to the patient giving birth with the aim of reducing the flow from the blood vessels when it is envisaged that the incision may result in an immediate and sudden loss of a very large amount of blood, owing to particular physiological parameters of the patient giving birth, such as high blood pressure or specific anatomical conditions, such as the presence of varicose veins along the incision line L, or other complications.

[0037] The aforementioned physiological and anatomical conditions may be measured before programming the Caesarean delivery operation, by means of an ultrasound scan or other instrumental detection methods, thus allowing the surgeon to plan application of the blood-flow reduction device together with his/her team, before carrying out the operation. Obviously, a surgeon may employ the blood-flow reduction device according to the present invention for all the Caesarean delivery operations for which he/she is responsible, including those where there is an unpredictable risk, namely operations where there are no anatomical or physiological conditions leading one to assume that there will be an exceptional blood loss as a result of the incision.

[0038] The incision line shown in FIG. 3 is schematically indicated by L and is located a few centimetres above the pubis of the patient giving birth. Entirely by way of example, FIG. 3 shows a number of broken lines, extending transversely with respect to the line L, which indicate possible varicose veins, i.e. blood vessels which have a cross-section anatomically larger than normal, and which therefore may be the cause of potential complications after severing. Obviously, in the human body these veins may extend with a geometry different from that shown by way of example in FIG. 3 and therefore intersect the cutting line L differently from that shown. Similarly, the complications may arise from blood vessels which have a cross-section which is normal, but which are affected by a high blood pressure.

[0039] The blood-flow reduction device 1 is provided with a frame 2 defining internally a free area 3 inside which the cut may be performed along the incision line L of the uterus. The frame 2 is intended to close off the varicose veins or the blood vessels after the incision has been made, or at least reduce significantly the blood flow, preventing the area 3 where the surgeon must operate from being obscured by the blood. In other words, the frame 2 is intended to be kept in pressing contact with the body of the patient and to remain in contact with it, including the uterus, during cutting, mutually constricting the varicose veins or other venous vessels, upstream and downstream of the line L.

[0040] When the uterus has been cut, by about 2 centimetres, the surgeon may insert a finger inside the uterus and attempt to make contact with the baby, locating the head, a foot or the buttocks, while a surgical assistant continues to keep the frame 2 in contact with the patient.

[0041] In order to exert a pressure sufficient to interrupt the blood flow, it is envisaged that the blood-flow reduction device may be provided with a gripping means 4. The pressure is applied, preferably from the start of the cutting operation and is maintained at least until the surgeon is able to make contact with the baby to be delivered. Only when the surgeon makes contact with the baby, identifying its position in the uterus, is the pressure on the frame released; in fact, after gripping the baby, the surgeon may proceed relatively quickly to extract it and immediately deal with stopping the bleeding of the patient, even if it is copious.

[0042] In the example shown in FIG. 3, the gripping means 4 is composed of a pair of handles 4, 44 which are formed as one piece with the frame 3, which is for example a closed ring, having an elliptical form. The handles 4, 44 are situated on the portions of the elliptical ring which are spaced furthest apart from each other. During use, these portions of the elliptical ring may be substantially aligned with the line L; a surgical assistant may take hold of the handles 4, 44, while remaining to one side of the patient giving birth and press with a suitable force the frame 3 on the patient, without disturbing the surgeon, who instead remains positioned between the legs of the patient and is able to concentrate on cutting and the following steps.

[0043] The frame 2 may be substantially flat and the handles may be perpendicular to the flat frame or spaced angularly with respect to the plane of the flat frame, at an angle greater than 90°, for example 120°.

[0044] The example provided with reference to FIG. 3 does not however limit the scope of protection of the present invention. In fact, the frame 2 may have a circular, square or polygonal form; moreover, for each of these forms, the frame 2 may be closed ring, an open ring or a ring which can be opened. Still according to variations of embodiments of the present invention, the handles may be situated on the portions of the frame which are arranged close together, for example on portions of an elliptical shaped frame arranged close together.

[0045] In the example of embodiment shown in FIG. 4, the frame 2 is rectangular and the handles 4, 44 are located on the opposite smaller sides of the frame 2.

[0046] In particular, according to one aspect of the present invention, again described with reference to FIG. 4 only by way of example, the frame 2 is further associated with an aspirator 5 which is able to remove from the area 3 the liquid blood dispersed by severing of blood vessels along the incision line L. In fact, even of the frame 2 is kept pressed against the patient giving birth before performing the cut and thus also blocking off the flow of the blood vessels below the frame 2, the blood which is inside the part of the vessels extending inside the area 3 of the frame 2 cannot be prevented from at least partially flowing out into the area 3, after cutting, thus obscuring the area 3 and reducing the visibility. Advantageously, the aspirator 5 removes the blood from the area 3, keeping it clean and clearly visible.

[0047] In the example shown in FIG. 4, the frame 2 has a first surface (in this case with a rectangular shape) intended to remain in contact with the body of the patient giving birth, a second surface (or side 2a), for example situated at 90° with respect to the first surface, and a third surface, parallel to the first surface. In particular, the first, second and third surfaces of the frame 2 form a C-shaped section having an opening directed towards the area 3. The first surface, and preferably also all the remaining surfaces of the frame, is/are lined with a biocompatible and sterilizable material; moreover the frame 2 does not have sharp corners.

[0048] The flank 2a is provided with connections 6 for the aspirator 5, which are for example situated on the sides of the frame 2 adjacent to the smaller sides on which the handles 4, 44 are mounted. The ducts of the aspirator 5 supply the blood sucked from the area 3 towards a collection tank (not shown), thus cleaning the area 3 of the blood.

[0049] The suction ducts, according to another aspect which falls within the scope of protection of the present invention, may be formed by the handles 4, 44. For example, the proximal handle 4b close to a first handle 4 may emerge in the area 3 towards the centre of the frame 2. Similarly, the second handle 44 may have a respective proximal connection piece 44b, close to the frame 2, which emerges in the area 3, on a side of the frame 2 opposite to the side where the proximal connection piece 4b of the first handle 4 emerges. FIG. 4 therefore shows four aspiration ducts (and therefore four respective connection pieces connected to the frame), but the scope of protection of the present invention may also include devices with a single aspiration duct and with two or more aspiration ducts, optionally only two ducts which are incorporated in the handles.

[0050] According to another aspect of the present invention the frame 2 is a ring which can be opened. In particular, two components of the frame 2 (not shown) may be engaged and disengaged. When the components are engaged, the frame 2 forms a closed ring and when the components are disengaged the frame 2 forms an open ring. Advantageously, according to this embodiment, the removal of the frame 2 from the patient's body is facilitated when the surgeon has made contact with the baby inside the uterus, since the frame 2 may be opened by moving the disengageable components around the surgeon's arm, without the surgeon removing the finger or fingers from the uterus. For example, the disengageable components are formed by a fixed portion of the frame and by a movable portion, the movable portion being rotatable about a hinge of the frame 2. Other engaging and disengaging means, preferably of the quick release type, may be used in order to speed up removal of the frame 2 from the patient giving birth without interfering with the surgeon's arm.

[0051] The advantages of the blood-flow reduction device according to the present invention may be briefly summarised below.

[0052] The device prevents uncontrollable blood haemorrhages and flooding of the area where the surgeon must operate and blocking of his/her vision of the tissues underneath the cut. The device allows the surgeon to perform the Caesarean delivery operation rapidly and reach the baby quickly. Risk situations both for the patient giving birth and for the baby being delivered are thus avoided.