ES2598777A1 - Separator for surgery. (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

Separator for surgery, especially thoracic surgery, formed by a "U" structure with a central section (1), a sliding arm (2) and a second arm (3), similar and parallel to the sliding arm (2), and fixed on the central section (1) by means of a connector (4) that allows the positioning of the second arm (3) in several positions of longitudinal rotation. The sternal valves (8) are slidable on the arms by means of guides (9) and can serve as support for additional rails (11) similar to the arms (2, 3). It can include other accessories such as flanges (12, 12 ') for valves (17) or other elements, supports for suture holders (19), mammary valves (25), combined with thorax pushers (27), etc. (Machine-translation by Google Translate, not legally binding)

Description

Surgery Separator

5 SECTOR OF THE TECHNIQUE

The present invention relates to a retractor or separator for surgery, especially for cardiac surgery, although it can be used in other operations that cannot be performed by arthroscopy and require opening the rib cage.

10 It is applicable in the medical field.

STATE OF THE TECHNIQUE

15 In conventional open heart surgery, middle sternotomy is performed to reach the heart and aorta. To give a correct access, a separator is required to keep the approach open, in addition to some leaflets to give the correct access to the valves. On the other hand, the patient must be connected to the cardiopulmonary bypass machine. This machine does the work of the heart and lung, supplying oxygen and eliminating

20 carbon dioxide.

If the mitral valve is repairable, annuloplasty can be performed by implanting a rigid or flexible ring, triangular or quadrangular resection, implanting artificial cords, etc.

25 If the valve is badly damaged, it is replaced with a mechanical or biological prosthesis.

 Mechanical: It is durable, but requires anticoagulant treatment for life.  Biological (bovine or swine): It usually lasts 12-15 years in the aortic position and 8-10 years in the mitral position and requires antiplatelet therapy with aspirin.

Another example of application of the invention would be coronary revascularization surgery. In it a bridge is made to bring blood to the distal part of the coronary arterial stenotic or obstructed using a graft:

35  Arterial: such as the left internal mammary artery (LIMA) or right (RIMA) and the radial artery. 2

 Venous: like the internal saphenous vein.

Most surgeons use the extracorporeal circulation machine to maintain the empty and stopped heart (ONCAB), while others perform this type of surgery with the 5 beating heart (OPCAB).

Currently, in the technical field of surgery it is not known to use any external tooling to provide access for both valve surgery and coronary surgery. There is some instrument that offers that necessary access for valvular surgeries, or

10 exclusively for coronary surgeries, with the drawbacks that this entails.

For valvular surgeries there is a type of separator, type CosGrove. This separator provides access to the valves to be treated but carries with it a number of disadvantages:

15 -Today, to perform a combined heart valve and coronary surgery, it is necessary to use three types of separators: conventional Favaloro-Morse sternal separator, AMI sternal separator, and CosGrove valve separator.

-

It requires a “car” for holding the fixed and device valves. There is no possibility of placing or removing it during surgery as appropriate. 20 -The sterile leaflets are fixed to the separator. There is no possibility to exchange these leaflets to adapt to the anatomy of each patient.

-

The placement of the separator in patients with short or rigid thorax is simple, because the leaflets are fixed to the separator, it is very difficult to place the incision.

25-It is not allowed to fix the suture organizers to the separator. You have to fix them to the field with tweezers and sutures. This is a problem since the surgical field is independent of the field created by the suture organizer.

For the performance of coronary surgeries, there is a specific AMI sternal separator. 30 This separator also has a number of disadvantages:

-

It is not applicable for valve surgery. -The breast valves move in a plane and do not adapt completely to the sternal edge. 35 -In patients with a rigid thorax, the mammary artery cannot be visualized correctly. 3

The applicant does not know any type of multipurpose separator, capable of being used in both surgeries.

5 BRIEF EXPLANATION OF THE INVENTION

The invention consists of a retractor or separator for thoracic surgery according to the claims.

10 Provide excellent surgical access by separating the sternum and soft tissues during any thoracic surgery, especially in valvular and coronary heart surgeries.

The advantages of the different embodiments of the invention are the following:

15 -The separator is multidisciplinary for thoracic surgeries, especially for valvular and coronary cardiac surgeries. In many cases these two types of surgeries are performed during a single intervention. With this invention only one separator is necessary for the entire intervention.

20 -The separator adapts perfectly to the patient's curve due to its anatomical design and versatility, being able to change the angular position of the accessories installed on one arm. -It has a zipper to open the incision in a controlled manner, similar to other retractors of the prior art.

25 -The sterile leaflets are mobile and removable. In most separators the sterile leaflets are already fixed and may differ from the most convenient for the surgeon team. This feature allows the separator to be easily mounted, since the leaflets can be placed first in the desired position of the incision and then insert the separator arms into the leaflets to

30 perform retraction. In addition, being removable, they can be selected or changed to adapt to the physiognomy of each patient. -Allows the attachment of the accessory of the Spanish application P201531065. It corresponds to a special mitral valve (SALAS) applicable during conventional mitral valve surgery.

35 -The accessories are easily mountable and removable so that they can be incorporated or removed when necessary. So when the 4 is not necessary

use of an accessory, do not bother surgeons and do not interfere with the vision of the surgical field. It also facilitates the sterilization of the accessory. -You can add leaflets at any point of the separator and also reach any point of the surgical field to give appropriate access.

5 -Accessory to fix the suture organizers or suture holders in a firm manner and in the proper position, since it allows them to be placed in the desired position and is designed to keep the organizer during the intervention.

-

The mammary leaflets are removable and mobile with respect to the arm of the separator, they can be easily added to the separator. In addition the presence of one or more axes

10 of rotation allows to orientate them with respect to the perpendicular axis of the plane of the surgical field and of the parallel axis, obtaining its correct adaptation to the sternum. In addition, they have adapted a chest pusher that improves the visualization of the mammary artery in coronary surgery. -The fact that the accessories are removable and only placed if necessary

15 its use, supposes a better visual field and does not hinder the surgeon.

In particular, the invention relates to a separator for surgery, especially cardiac surgery.

or any thoracic surgery in which the opening of the thorax is necessary, formed by a central section carrying a zipper on which a sliding arm of constant non-circular section 20 (square, rectangular, polygonal, ...) is mounted so that they can slide on it the different elements and accessories of the separator. It also has a second arm similar and parallel to the sliding arm, fixed on the central section by means of a connector that allows the positioning of the second arm in several longitudinal turning positions. This second arm can be removable to facilitate installation. The non-circular section

25 of the arms is required so that the rotation positions along the longitudinal axis offer a variation in the position of the elements and accessories mounted on the arm. In case of being circular, the orientation of these would not depend on the angular position of the second arm.

30 The main use of these arms is the installation of at least one sternal leaflet that has a sliding guide over them. As will be seen later, the number of sterile leaflets will depend on the application, generally being one or two. In each sternal leaflet a support can be provided for a rail, similar to the arms, and arranged on a level higher than these. This increases the ability to place accessories in the field

35 surgical. In the preferred variant, the rail fastener consists of an adapter with a

lower part in male dovetail attachable in the mouth of the guide and on which the rail is arranged.

A first optional accessory is a flange, which can be placed by means of a jaw in the

5 rail, in one arm (in both cases they are the same) or in the zipper of the central section. Flange It has a fixation for elements such as leaflets attached to the jaw by a ball joint to allow Orient this one.

The flange rack jaw will have, like other jaws of the technique, a knob of

10 tighten to fix to the zipper, but whose end of contact with the central section not only makes the fixation by tightening, but also closes the opening of the zipper jaw.

The preferred example of flange attachable leaflet is a handle with one or more rods

15 layered The specific shape of the leaflet will depend on the intended use of the leaflet, as well as the size of the patient.

A second optional accessory is a suture holder holder, which comprises a suture holder holder and is attachable by means of a fixation on the rail, arm or on the

20 own sternal leaflet. Preferably, the suture holder holder has a rotation axis perpendicular to it to allow the orientation to vary according to the final position of the suture holder, but always in a position parallel to the patient's body. Preferably, the suture holder holder is attached to the fixation by means of an extension which helps to remove it from the surgical field, either to the left or to the left.

25 right. Generally, several suture holders will be required to be installed during operation.

A third optional accessory is a breast valve support formed by a breast valve flange attached at one end to a breast valve by a stem with one or more

30 rotation points and, preferably, on the other to a chest pusher formed by a pusher platform attached to a threaded stud in a solidary bushing and distant to the breast valve flange. The pusher platform can be attached to the threaded stud by a ball joint.

35 DESCRIPTION OF THE DRAWINGS

For a better understanding of the invention, the following figures are included.

Figure 1: Perspective view of an exemplary embodiment in the standard sternal separator configuration.

5 Figure 2: Perspective view of an embodiment example in the separator configuration for valve surgery.

Figure 3: Perspective view of an exemplary embodiment in the AMI sternal separator 10 configuration for coronary surgery.

Figure 4: Perspective view of an example of a sternal leaflet with a two-part guide. One first to slide on one arm and another second in female dovetail.

15 Figure 5: view of an adapter according to an exemplary embodiment.

Figure 6: view of two flange variants, each in perspective and in section, one to be fixed to the rail or arm and another to be fixed to a rack.

20 Figure 7: view of an example of leaflet.

Figure 8: view of two variants of support for suture holders.

Figure 9: Perspective view of an example of a breast valve with a chest pusher. 25

EMBODIMENTS OF THE INVENTION

Next, an embodiment of the invention will be briefly described as an illustrative and non-limiting example thereof.

The retractor or separator is formed by a "U" structure with a central section (1), a sliding arm (2) and a second arm (3). The arms (2,3) will be parallel to each other and will have a similar length and section so that the elements that are mounted on the arms (2,3) are interchangeable. The second arm (3) will be installed on the central section (1) by means of a

35 connector (4) (for example female) with regular geometric shape so that the connection of the second arm (3) can take several positions or angles of rotation 7

The sliding arm (2) will be movable along the central section (1) by a method that allows transmitting force. The preferred form is a rack (5) in the central section (1) and a cage (6) for the rack (5) so that the sliding arm (2) can be moved by the rack (5), for example a through the rotation of a crank (7) with a pinion (not visible) inside the cage (6). If necessary, position interlocking means will be installed, for example by means of a clamp and ratchet mechanism (not shown). Systems like this are known in the art and need not be specified.

The sterile leaflets (8) will be installed on the arms (2,3) of the separator, which may exist in different sizes so that they can adapt to the different anatomies of the patients. They will have guides (9) so that they can slide along the arms (2,3) to be placed in the most optimal position. The preferred guides (9) consist of a mouth groove narrower than the body, so that the introduction is from the corresponding free end of the arm (2,3). If desired, there may be means to immobilize the sternal leaflet in position (8). The mouth of the guide (9) of the embodiment of Figure 4 is of converging walls to define a second space, in dovetail, where an adapter (10) can be arranged as shown in Figure 5. This adapter ( 10) consists of a first part in male dovetail, to enter the mouth of the guide (9), and a second part consisting of a rail (11) similar in section to the arms (2,3). In this way a new support is available for the other components of the separator. A screw (11 ’) can be arranged on the rail to fix the adapter in the desired position.

Another optional component is shown in Figures 6A and 6B, and consists of a rail flange.

(12)

which will generally be fixed on the rail (11) to free the arms (2,3) to the sterile leaflets (8). This rail flange (12) consists of a jaw (13) with a clamping knob (14), on which a ball joint (15) is placed that generates the degrees of freedom of a fixation.

(16)

of the component fixed by the rail flange (12). Between the jaw (13) and the kneecap (15) there will be a certain distance to give the latter more freedom of movement. In fixing

(16)

 any necessary element can be fixed, such as a leaflet (17) or a support for suction cables or pipes, etc. The simplest form of the fixation (16) is a groove for introducing one end of the element to be fixed, which will then be immobilized by a captive screw whose head can be a serrated crown, a dove, etc.

In the central section (1) it should also be possible to fix rack flanges (12 ’) that in this case cannot be introduced from the ends. Therefore the preferred solution is to arrange 8 5

a rack jaw (13 ') where the contact end of the corresponding clamping knob (14') with the central section (1) is pressed against it and at the same time closes the exit passage, for example with a lower projection like the represented. You will also understand your kneecap

(15) and fixing (16), equal to those of the rail flanges (12), being able in any case to be more separated from the rack jaw (13 ') since the central section (1) will generally be in a plane lower than the rail (11).

A main use of the flanges (12,12 ') is the fixing of leaflets (17), composed of a handle that can be attached to the fasteners (16) of the flanges (12,12') and one or more rods (18) angled that make up the body of the leaflet (17) and that can be of different sizes and designs and that is the one who performs the tissue separation.

Another accessory of the separator is a support for suture holders (19), which can be placed on the rail (11), an arm (2,3) or the sternal leaflet (8), depending on the variant. In all cases, the suture holder support (19) will comprise a suture holder holder (20), with an optional extension (21) to separate it from the surgical field, and a sliding fixation for the rail (figure 8A) or dovetail (figure 8B) for the guide (9) of the sternal leaflet (8). Preferably, the suture holder holder (20) is mounted on a shaft (22) for total rotation and can have a handle (23) to fix this rotation in the desired position. Two examples thereof are shown in Figures 8A and 8B.

The last accessory to be described is the breast valve support (24) (figure 9), which comprises several parts. The first is the breast valve itself (25) formed by a curved plate with teeth at its free end. The breast valve (25) is fixed to the corresponding arm (2,3) of the separator by means of a breast valve flange (26) similar to those already described. The union between the mammary leaflet (25) and the flange of the mammary leaflet (26) will be by a rod with one or more rotation points to allow the mammary leaflet (25) to be oriented with respect to the planes parallel and / or perpendicular to the field surgical. Generally, a shaft rotation point perpendicular to the arm (2,3) will suffice, but if several are placed, they will be perpendicular to each other. It also includes a chest pusher (27) formed by a pusher platform (28) at the end of a threaded stud (29) that rotates by means of a threaded knob (30) in a bushing (31) integral, but distant, to the flange of the breast valve (26). Between the threaded stud (29) and the pusher platform (28) a ball joint can be installed to allow the pusher platform (28) to adapt to the thorax.

The dimensions of each accessory may vary, mainly depending on its use in adults, children, overweight people, etc.

The invention will be explained in its three main configurations, which are represented in Figures 1 to 3.

In figure 1 it is represented in a standard sternal separator configuration, applicable for any surgery in which it is necessary to separate the sternum. It consists of the central section (1), both arms (2,3) and the sterile leaflets (8), which can be of different sizes and

10 easily interchangeable.

Figure 2 shows the invention in its configuration as a separator for valve surgery. In this case, in addition to the elements of the previous configuration, an adapter is fixed on the sliding arm (2) to have a rail (11) that serves to carry several

15 rail flanges (12). There is also a zip flange (12 ’). These flanges (12,12 ’) are used for the fixing of two leaflets (17). Three leaflets (17) have been represented but the necessary number may be different.

In this application, three suture holders (19) are arranged, two of them fixed

20 to the rail (11) and one last to the guide (9) of a sternal leaflet (8), delimiting the surgical field between the three suture holders (not referenced).

Figure 3 shows the third main application, as an AMI sternal separator for coronary surgery. In this case, it will be necessary to arrange a sternal leaflet (8) on one arm

25 (2,3) and breast valve holders (24) on the opposite arm (2,3). It can be seen how the second arm (3) has been rotated with respect to the sliding arm (2), thanks to the geometry of the connector (4).

Other configurations are possible, depending on the need of the surgeon or medical staff, 30 including wiring brackets, for suction pipes, etc.

Claims (1)

1-Separator for surgery, especially thoracic surgery, formed by a “U” structure with a central section (1) carrying a zipper (5) on which an arm is mounted 5 slide (2) of non-circular constant section characterized by having a second arm (3) similar and parallel to the sliding arm (2), and fixed on the central section (1) by means of a connector (4) that allows the positioning of the detachable arm (3) in several longitudinal turning positions. 10 2-Surgery separator according to claim 1, which has at least one sternal leaflet (8) with a guide (9) sliding on the arms (2,3). 3-Separator for surgery, according to claim 2, wherein the sternal leaflet (8) has a support for a rail (11) similar in section to the arms (2,3) and arranged at a higher level. 15 4-Surgery separator according to claim 3, which has at least one flange (12,12 ') containing a jaw (13,13'), attachable to an arm (2,3) or to the rack (5) from the central section (1) connected by a ball joint (15) to a fastener (16) applicable to leaflets (17). 20 5-Surgery separator according to claim 4, wherein the rack-mounted flange (12) to the rack (5) has a rack clamp (13 ') where the contact end of the clamping knob (14') of the rack jaw (13 ') with the central section (1) closes the opening of the rack jaw (13') 25 6-Surgery separator according to claim 3, wherein the leaflet (17) is composed of a handle that can be attached to the fasteners (16) of the flanges (12,12 ’) and one or more rods (18) angled. 7-Surgery separator according to claim 2 or 3, which has at least one support for suture holders (19) comprising a fastening element of the suture holder (20) attachable on the rail (11) or on the sternal valve (8). 8-Separator for surgery, according to claim 7, wherein the holder of the holder (20) has an axis (22) of rotation perpendicular to it. 35 9-Surgery separator, according to claim 7, wherein the holder of the holder (20) is attached to the fixation by means of an extension (21). eleven 10-Surgery separator according to claim 1, which has at least one breast valve support (24) formed by a breast valve flange (26) joined at one end to a breast valve (25) by a stem with one or more rotation points. 11 11-Surgery separator, according to claim 10, wherein the breast valve flange (26) is attached at its other end to a chest pusher (27) formed by a pusher platform (28) attached to a threaded stud (29) ) in a bushing (31) integral and distant from the breast valve flange (26). 12 12-Surgery separator, according to claim 11, wherein the connection between the pusher platform (28) and the threaded stud (29) is carried out by means of a ball joint. 13-Surgery separator, according to claim 3, wherein the rail support (11) 15 consists of an adapter with a lower part in male dovetail attachable in the mouth of the guide (9) on which the rail (11).  FIGURES