ES2451845A1 - Vascular anastomosis prosthesis with clip (Machine-translation by Google Translate, not legally binding) - Google Patents

Abstract

The present proposed invention provides a solution for those surgeons who need to join two or more blood vessels by a multitude of degenerative or accidental diseases. This solution is simple to apply, quick in its placement but, above all, safe, effective and durable. A vascular prosthesis is proposed that reduces the possibility of thrombi. The prosthesis is attached to the blood vessel with a pressure-fenestrated clip, without deforming the prosthesis. This solution significantly reduces the time of the surgical act. The prosthesis may have one or several mouths in or out. For the placement of the prosthesis a special device has been conceived, with tips that dilate the blood vessel. (Machine-translation by Google Translate, not legally binding)

Description

VASCULAR ANASTOMOSIS PROSTHESIS WITH CLIP

Technical sector

The present invention is included in the medical-surgical sector and within it, in the surgical treatment of diseases of the blood vessels. This subsector tries to create a continuity in blood flow through autogenous and / or artificial implants. Said solution of continuity in the blood vessels can be carried out by means of an implant in a programmed operative environment in cases of degenerative diseases or in an emergency environment to provide an extremely rapid channeling of blood vessels.

Background of the invention

Currently, vascular anastomosis is performed by surgical suture, so that the suture surrounds the perimeter of the vessels when it is term-terminal and the mouth of the vessel with the wall of the recipient when it is term-lateral.

In addition, in sections of a certain length, an autologous or heterologous vascular graft must be added to this suture, which must be sutured in the manner mentioned above. In the By-passes, the anastomosis is performed by means of a terminal-lateral suture. This suture necessarily implies a high degree of specialization in this type of surgery and a lot of operative time.

On the other hand, there are patents prior to the present invention that attempt to improve said surgical suture by means of implant devices that attempt to replace the manual suture, but which do not provide the technical solutions referred to in our invention.

Therefore, it is necessary a system that connects quickly and reliably two blood vessels confronted or away, tending a bridge that leads the blood inside and that reduces surgical times to the maximum thanks to its simplicity in placement.

As we have said before, the conventional suture of one end of these prostheses to the blood vessel is often technically difficult to perform and leads to the malfunction of the prosthesis due to technical defects in this anastomosis. Also, at the level of this suture between prosthesis and vein, a stricture or narrowing develops very frequently due to what is called intimal hyperplasia, which normally leads to the obstruction of the prosthesis, this being the most frequent cause of failure Long-term use of this type of prosthesis, as contemplated in US3166072, W09965409, ES2292347, ES1023771, US2010036398 and US2004254595.

Said anastomosis must be safe and have no risk of damaging the internal or external structures of the blood vessel, which contemplates this invention unlike patents :, US3166072, US2004254595, EP0158316, US4214587, US2007173868, US4368736 and in the same way, have a secure fixation without danger of loosening during the life of the patient and never providing an unsecured fixation as in the case of US3166072, ES2292347, ES1023771, US2010036398, US6402767, US2008195125, US2004254595, EP0158316, US4470415, US3155095 and US2453056. .

The external fold on itself of the vessel as an anastomosis procedure in addition to being extremely complex to execute, is also insecure due to the risk of cracking in it, as can be seen in patents US4728328, US3774615, W09965409, EP0158316 and US2453056, and what remains Resolved in our patent. Similarly, as can be seen in the patents: DE2034413, US3774615, US3166072, W09965409, ES2292347, ES1023771, US2008195125, ES2374073, US1814539, US4470415 and US4368736, the external closures that throttle without arranging the blood vessel are not safe an internal area that ensures said pressure, avoiding transferring it into the lumen of the blood vessel. , which has been foreseen in our invention, as can be seen from the text of this report.

Another important aspect when carrying out the proposed anastomosis is the simplicity of execution, unlike patents W09965409, W02010026429, US2010036398, US6402767, US2004254595, ES2374073, US5503635, US2007173868, US4470415 and US4368736, where there are too many pieces device, too many steps in the execution of the surgical act; or unnecessary doses of anesthetic drugs that increase the execution time.

Even if said instrument or / and implant is simple, we may have difficulties, which are covered in the present invention when working in small fields such as 4mm vessels, this problem is observed in the patents: US4728328, US3774615, W09965409, W02010026429, US2010036398, US6402767, US2008195125, EP0158316, ES2374073, US4368736 and US2453056.

In the case of using implants to join the vessels, several problems arise, among them the most important ones are to achieve a permanent and secure implant-vessel union.

On the other hand, it is important to note that both the afferent and efferent ends of the

5 needs are very different, since the entry of blood into the implant could generate a thrombogenic effect of the blood. If it does not adapt to the physiological needs. Such a difference is correctly solved in the present invention, which does not happen in the patents. DE2034413, US4728328, US3774615, US3166072, W09965409, ES2292347, ES1023771, W02010026429, US2010036398, US2008195125, US2004254595, EP0158316, US4214587,

10 US5503635, US2007173868, US1814539, US4470415, US3155095, US2453056. .

Finally, said blood flow ° is affected by excessive changes in the diameter of the light and accidents in the blood flow ° derived from the structure inside said implants 15 as in patents W09965409, W02010026429, ES2374073 and US5503635 or the result of the suture between the vessels or between the implant vessel, as in the case of patents U54728328, U52010036398 and US2008195125, giving small variations in said flow that leads to risks of thrombus formation, which once in the bloodstream ° In general, they could lead to severe thromboembolism or embolism and sometimes even cause death. This

20 circumstance is resolved in the present invention, as contemplated in this specification.

Object of the invention

Provide a simple, reliable, rapid ° device with minimal side effects, avoiding subsequent pathologies to its implanted & like: avoid post-surgical adhesions and the 5 formed & of thrombi. The device performs a permanent union of blood vessels. Its use is oriented to scheduled or emergency surgery.

Description of the invention

The present invention offers advantages and innovative technical solutions with respect to existing devices in the state of the art.

10 The greatest advantage of the present invention is its simplicity in the placement of the prostheses, compared to the manual suture or the different systems presented in the state of the art, since only with an instrument that opens the mouth of the blood vessel, Insert the implant and a fenestrated clip is placed at each end of the prosthesis, leaving the blood vessel connected to the implant.

15 The use of a fenestrated clip such as the one presented in this invention offers a great advantage with respect to rings and fasteners, since they have to be deformed. In these technical solutions where the clamping piece has to be deformed, the blood vessel can be sectioned due to excess pressure or become loose and loose over time. The fenestrated clips that are proposed exert a certain pressure according to the diameter of the blood vessel. This pressure is regulated

20 during the manufacturing process and verified with quality control.

To ensure that the pressure exerted by the clip does not deform the implant, the rings are placed in a toroid of rigid material integral with the implant, avoiding the intimal hyperplasia or retraction generated, with the two ends of the vessels attached and in contact.

Another advantage of using a fenestrated clip that performs the pressure to maintain the

The union is that it does not have elements that pierce the vessel, nor folded on itself that exceed the elastic limit of the blood vessels, preventing them from suturing or giving the vessel to ensure said fixation. Our invention achieves the greatest Ned & with the tubular clamp between clip and inner ring of the prosthesis ensuring the anti-slip with the incorporation of a knurling or rough area on both sides of the prosthesis and the clip.

Our invention provides a simple placement instrument for each of the diameter options, being quick and easy to place in small and large fields, something that objectively improves the surgical technique and makes it more versatile.

5 Our prosthesis has an arnica geometry which greatly improves the flow rate inside the device. This, together with the homogeneity of the interior light, gives the invention a great antithrombogenic character. In this sense, the ends of exit and especially the one of entrance, have a form that practically reduces to the imperciptibility the accident that supposes for the flub or sanguine ° to happen of the glass to the prosthesis.

It should also be borne in mind that our prosthesis could be used in terminoterminal and terminolateral anastomosis since it is contemplated the development of variants of various forms for both alternatives in the different anatomical variants, at least the statistically most possible ones.

15 Artificial vascular anastomosis prosthesis joins the prosthesis to the blood vessel without suture. The pranthesis is a tube or union of several tubes, open at all ends, with closures at each end that press the blood vessel between the closure and the prates. The vascular type clip for aneurysms has a pressure inverter strap to make a clamp

20 flat in the blood vessels, cutting off the blood flow °. The vascular anastomosis prosthesis has a clip (1) (Figure 1, 2 and 3) that presses the blood vessel (5a) (Figure 1) against the tubular prosthesis (7a) (Figure 1). The clip has a fenestra (3) (Figure 1 and 2) formed by at least one curve, covering at least the entire outer perimeter of the prosthesis (7a) (Figure 1) at its anchor point (4) (Figure 1 ). The fenestra has two opening ends (16) (Figure 1, 2 and 3) and

25 is connected with conventional means such as welding or is integral with a strap (2) (Figure 1 and 2) at least two points (21) (Figure 2). With the strap of the clip pressed (22a) (Figure 3) the fenestra opens at least until the distance "d" (23) (Figure 3) between the opening ends is greater than the tubular prosthesis at its anchor point together . The prosthesis is made of a semi-flexible material, it has at least one mouth (10a) (Figure 1) inlet and at least one outlet

30 (20a) (Figure 1) of blood flow ° (11a) (19a) (Figure 1), the inlet and outlet have an inside diameter (13) (Figure 1) equal to or greater than that of the blood vessel ° (5th) (Figure 1), the song

(12) (Figure 1) of the inlet mouth is flared and rounded. The exterior of the entrance and the exit mouth have at least one anchor point (4) (Figure 1) consisting of a concave recess in the entire perimeter of the prosthesis. The prosthesis at the anchor point (4) (Figure 1) has a toroid (8) (Figure 1) fixed in rigid material, with the smooth inner face (14) (Figure 1) and the face

5 outside with at least one concavity (15a) (Figure 1). The prates's has a body (9) (Figure 1), which joins the inlet and outlet mouths, with an outside diameter (6) (Figure 1) smaller than that of the inlet mouths (10a) (Figure 1) or outlet (19a) (Figure 1), the inside of the body has a conical shape (17) (Figure 1) with its inner diameter at the inlet mouth greater than that of the blood flow outlet °.

10 In Figure 10, an example can be seen where the artificial prosthesis of vascular anastomosis has an entry mouth (10b) (Figure 10) through which the blood flow enters (11b) (Figure 10) and more than one mouth exit (20b) (Figure 10) through which the blood flow (19b) (Figure 10) leaves the prosthesis.

To reduce the necessary force and avoid the deformation that occurs in the fenestra when opening the clip, it is envisaged to have at least one discontinuity (24) (Figure 4 and 5) in the curve of the fenestra.

A version of the fenestra of the clip that improves the union with the blood vessel and its

feeding, disposing on the inside of the fenestra of undulations or notches

(25) (Figure 6).

20 A version of the clip is provided, in which to open the fenestra, the force that is performed is extensive and not compressive. In this way, you get a simpler version to manufacture and therefore, more economical. In this version, the strap of the clip is attached to the fenestra without crossing (26) (Figure 7), being pressed (22b) (Figure 7) of the strap is in the opposite direction.

In the device of the present invention, it is provided, to improve the grip and the

25 alignment between the clip and the prates's, that the clip's fenestra has at least one recess in its inner face (27) (Figure 8) and the stiff material toroid (15b) (Figure 8) on its outer face fits with the inner face of the fenestra.

To reduce the procedure and the time of execution of the surgical act, the clips can be transported together with the vascular implant, having at least one body in the prosthesis body

30 perimeter protuberance (29) (Figure 9), with a concave recess (28) (Figure 9), in which to place the clip.

A device specially designed for the placement of artificial prostheses of vascular clip anastomosis during surgery has been devised quickly, efficiently and safely. This device for the placement of artificial prostheses of vascular anastomosis with clip, opens the blood vessel ° with its tips (33a) in a blood vessel ° (5cc) previously sectioned. Through the interior of the channel (35a) of the device, the prosthesis is inserted into the interior of the blood vessel, and is fixed by placing a fenestrated clip in each mouth of the prosthesis. This device has a cylindrical channel (35a) (Figure 11) with an inside diameter larger than the prosthesis (7c) (Figure 11). The channel is extended with at least two points (33a) (Figure 11) which in their closed position have an outside diameter smaller than the internal diameter of the blood vessel ° (5c) (Figure 11 and 12). The points

10 (33b) (Figure 12) in their open position have an inside diameter larger than that of the prosthesis, extending the channel (35b) (Figure 12) to the inside of the blood vessel °. The device has a conventional manual or motorized mechanism (31) (Figure 11) that opens or closes the tips.

For the performance of the surgical act, when the field of action allows it, a device has been conceived to place artificial prostheses of vascular anastomosis, which has a manual or motorized actuator (30a) (Figure 11), integral with a gear (34) (Figure 11), which transfers the movement to a rack gear (32) (Figure 11), parallel to the channel (35a) (Figure 11). The cogwheel gear has a perpendicular ring (36) (Figure 11) attached whose inner diameter interferes with an outer shoulder (37) (Figure 11) on each tip (33a) (Figure 11). The protrusion of the tip has a dimension, which does not interfere with the entire path 20 of the ring. The tips are made of a flexible or semi-rigid material. Note: Vertical movement advantage

or in one direction.

A version of the device to place artificial prostheses of vascular anastomosis is planned,

when the field of action is very small, which has an actuator (30b) (Figure

13) manual or motorized, of a mechanism (38) (Figure 13) conventional as a slide,

25 piston or rack gear. The mechanism displaces at least one tip (33c) (Figure 13) with respect to the rest of the tips (33d) (Figure 13) in the direction perpendicular to the channel. The channel (35c) (Figure 13 and 14) has a socket (40a) (Figure 14) that fits outside the mouths of the prosthesis (Figure 13).

A version of the device for placing artificial prostheses of vascular anastomosis is planned,

30 when the field of action is very small and the movements are restricted to the perpendicular of the incision. This device has a conventional scissor mechanism (42) (Figure 15 and 16), actuator (30c) (Figure 15) manual or motorized. The scissor has a tip

(33e) (Figure 15) at each end (43) (Figure 15). The mechanism separates or approximates the tips (33e) (Figure 15), the opening and closing is limited by at least one stop (41) (Figure 15). The channel (35d) (Figure 16) has a fitting (40b) (Figure 16) that fits outside the mouths of the prosthesis.

BRIEF DESCRIPTION OF THE DRAWINGS:

For the best understanding of what is described herein, some drawings are attached in which, by way of example only, a relation of the images of the anastomosis prosthesis, the closure clip and the device designed for the placement of the prosthesis.

Description figures:

Figure 1: Shows a complete section of the vascular anastomosis prosthesis (7a), implanted between the two ends of a blood vessel.

The blood flow direction (l1a) is represented, in addition the orifice of the blood inlet device (lOa), the body of the prosthesis (9) which progressively reduces its diameter is appreciated

(17) at the outlet (20a) and two clips (1) with their respective fenestras (3) placed at the anchor points (4) holding the end of the blood vessel. Inside both anchor points of the clips, a toroid (8) of rigid material is available to receive the pressure of the clip without deforming the inner diameter of the vascular anastomosis prosthesis.

We can also see in this section, the entire sectioned section of the clip, with the strap and the fenestra at the anchor points.

Figure 2: Shows the clip (1) in its closed position as it would be when placed in the prosthesis. The strap (2) is reverse opening. It shows the fenestra (3) that occupies the entire diameter, its opening ends (16) and the points of attachment (21) with the strap. The fenestra embraces the entire contour of the blood vessel.

Figure 3: Shows the clip (1) in its open position when the strap is pressed (22nd), being able to insert the prosthesis (7b) with blood vessel (5b) inside the fenestra. The strap is reverse opening. It shows the fenestra that occupies the entire diameter, its opening ends

(16) and the points of attachment with the strap. The fenestra embraces the entire contour of the blood vessel.

The distance d (23) indicates the maximum opening distance of the fenestra.

Figure 4: Clip for vascular anastomosis in closed position, with a discontinuity (24) in the fenestra.

Figure 5: Clip for vascular anastomosis in the open position, with a discontinuity (24) in the fenestra.

Figure 6: Clip for vascular anastomosis in closed position, with undulations inside the fenestra, increasing the adhesion to the blood vessel.

Figure 7: Clip for vascular anastomosis with non-inverted strap (26) and without crossing. The direction in which the force is to be made (22b) to open the fenestra is shown.

Figure 8: Vascular anastomosis and clip prostheses, which improve the support with a toroid and fenestra with recesses and greater surface area.

Figure 9: Shows the vascular anastomosis prosthesis with an area where the clip can be placed temporarily to transport it and facilitate placement.

Figure 10: Shows a version of the multi-connection prosthesis where there is an inlet (10b) and two outlets (20b) of the blood flow.

Figure 11: Shows the section of a device to dilate the mouth of the blood vessel and the placement of the prosthesis inside the blood vessel. This device has tips (33a) that are inserted into the vessel, a screw and gear actuator (30a) that moves the pressure ring (36) by separating the tips that the blood vessel dilates, through the channel (35a).

Figure 12: Shows the section of a vascular anastomosis prosthesis placement device dilating the blood vessel and introducing the prosthesis.

Figure 13: Shows the section of a device to dilate the mouth of the blood vessel and the placement of the prosthesis inside the blood vessel. This device has tips (33b) that are inserted into the vessel and a slide actuator (30b) (38) that separates the tips, dilating the blood vessel.

Figure 14: Shows the section of a vascular anastomosis prosthesis placement device dilating the blood vessel and introducing the prosthesis.

Figure 15: Shows a device to dilate the mouth of the blood vessel and the placement of the prosthesis inside the blood vessel. This device has tips (33e) that are inserted into the vessel and a scissor actuator (30c) that separates the tips, dilating the blood vessel. The scissors have a stop (41).

Figure 16: Shows the section of a scissors and canal vascular anastomosis prosthesis placement device.

DESCRIPTION OF A PREFERRED EMBODIMENT:

A preferred embodiment is cited by way of example, the materials used in the manufacture of the components of the vascular anastomosis prosthesis being independent of the object of the invention, the device specially designed for the placement of the prosthesis, the methods of application and all the accessory details that may arise, as long as they do not affect their essentiality.

A form of vascular anastomosis prosthesis is proposed, formed by different elements:

Artificial vascular anastomosis prosthesis, for a 5 mm diameter arterial blood vessel.

Vascular anastomosis prosthesis that has a clip (l) (Figure 1) (Figure 4 and 5) that presses the blood vessel (5aa) (Figure 1) against the tubular prosthesis (7a) (Figure 1). The Clip has a fenestra (3) (Figure 1) (Figure 4 and 5) formed by two curves with an inner diameter of 6 mm, which covers the entire outer perimeter of the prosthesis (7a) (Figure 1) at its point of anchor (4) (Figure 1), the fenestra has two opening ends (16) (Figure 1) and is attached to the strap at two points (Figure 4 and 5). The fenestra has a discontinuity (24) (Figure 4 and 5). With the strap of the clip pressed (Figure 5), the fenestra opens a distance of 7mm. The prosthesis is made of a semi-flexible material, it has an inlet (10a) (Figure 1) and an outlet (20a) (Figure 1) of blood flow (11a) (19a) (Figure 1). This inlet mouth is 5.2mm in diameter and the outlet has an inside diameter of 4.8mm, the edge (12) (Figure 1) of the inlet mouth is flared and rounded and with a special shape at the entrance of blood to prevent thrombi. The exterior of the entrance and the exit mouth have an anchor point (4) (Figure 1) constituted by a concave recess in the entire perimeter of the prosthesis. The prosthesis at the anchorage point (4) (Figure 1) has a toroid (8) (Figure 1) fixed in rigid material, with the smooth inner face (14) (Figure 1) and the outer face with at least one concavity (15a) (Figure 1). The prosthesis has a body (9) (Figure 1), which joins the inlet and outlet mouths, with a diameter of 5.5mm. The inside of the body has a conical shape (17) (Figure 1) with its inside diameter in the inlet mouth greater than that of the blood flow outlet.

The vascular anastomosis prosthesis has two perimeter protrusions in its body

(29) (Figure 9), with a concave recess (28) (Figure 9), where to place the two clips necessary for surgery.

For the transport, placement of the prosthesis and the dilation of the blood vessel, a device specially designed with a manual scissor mechanism (42) is used. The scissors have a tip (33e) at each end (43) of the scissors. The mechanism separates or approximates the tips (33e), the opening and closing or opening is limited by at least one stop (41). The inside of the tips form a channel (35d) through which to insert the prosthesis. This channel has a socket (40b) that fits to the outside of the mouths of the prosthesis, holding it.

Claims (9)

1. Artificial vascular anastomosis prosthesis characterized by having a clip (1) that presses the blood vessel (Sa) against the tubular prosthesis (7a). The clip has a fenestra (3) formed by at least one curve, covering at least the entire outer perimeter of the prosthesis (7a) at its anchor point (4). The fenestra has two opening ends (16) and is connected with conventional means such as welding or is integral with a strap (2) in at least two points (21). With the strap of the clip pressed (22a), the fenestra opens at least until the distance "d" (23) between the opening ends is greater than the tubular prosthesis at its anchor point. The prosthesis is made of a flexible material, it has at least one inlet mouth (10) and at least one outlet (20a) of blood flow (11) (19a), the inlet and the outlet have an internal diameter (13) equal to or greater than that of the blood vessel (Sa), the edge (12) of the inlet mouth is flared and rounded. The exterior of the inlet and the outlet have at least one anchor point (4) consisting of a concave recess in the entire perimeter of the prosthesis. The prosthesis at the anchor point (4) has a toroid (8) integral with rigid material, with the smooth inner face (14) and the outer face with at least one concavity (lSa). The prosthesis has a body (9), which joins the inlet and outlet mouths, with an outside diameter (6) smaller than that of the inlet (lOa) or outlet mouths (20), the inside of the body has a conical shape (17) its inner diameter in the inlet mouth being greater than that of the blood flow outlet.

2.

Artificial vascular anastomosis prosthesis according to claim 1, characterized by having at least one discontinuity (24) in the fenestra curve.

3.

Artificial vascular anastomosis prosthesis according to claim 1, characterized in that it has undulations or notches on the inside of the fenestra (2S).

Four.

Artificial vascular anastomosis prosthesis according to claim 1, characterized in that the strap of the clip is attached to the fenestra without crossing (26), being pressed (22b) of the strap in the opposite direction.

5.

Artificial vascular anastomosis prosthesis according to claim 1, characterized in that the clip fenestra has at least one recess in its inner face (27) and the rigid material toroid (lSb) in its outer face fits with the inner face of Fenestra

6.

Artificial vascular anastomosis prosthesis according to claim 1, characterized in that at least one perimetral protuberance is provided in the body of the prosthesis (29), with a concave recess (28).

7.

Clip artificial vascular anastomosis prosthesis placement device

s fenestrated during surgery, according to claims 1 to 6, characterized by having a cylindrical channel (3sa) with an inner diameter larger than the prosthesis (7c). The channel is prolonged with at least two points (33a) that in their closed position have an outer diameter smaller than the inner diameter of the blood vessel (sc). the tips (33b) in their open position have an inside diameter greater than that of the 10 prostheses and extending the canal (3sb) to the inside of the blood vessel. The device has a conventional manual or motorized mechanism (31) that opens or closes the tips. 8. Device for placing artificial stents of vascular anastomosis according to claims 1 to 6, characterized by having a manual actuator (30a) or motorized, integral to a gear (34), which transfers the movement to a gear 15 rack (32), parallel to the channel (3sa). The cogwheel gear has a perpendicular ring (36), whose inner diameter interferes with an outer shoulder (37) on each tip (33a). The protrusion of the tip has a dimension, which does not interfere with the entire course of the ring. The tips are made of a flexible or semi-rigid material. 9. Device for placing artificial prostheses of vascular anastomosis according to the 20 claims 1 to 6, characterized by having a manual or motorized actuator (30b), of a conventional mechanism (38) such as a slide, piston or rack gear. The mechanism displaces at least one tip (33c) with respect to the rest of the tips (33d) in a direction perpendicular to the channel. The channel (3sc) has a socket (40a) that fits outside the mouths of the prosthesis 25 10. Device for placing artificial stents of vascular anastomosis according to claims 1 to 6, characterized by having a conventional scissor mechanism (42), manual or motorized actuator (30c). The scissors have a tip (33e) at each end (43). The mechanism separates or approximates the tips (33e), the opening and closing are limited by at least one stop (41). The channel (3sd) has a lace 30 (40b) that fits outside the mouths of the prosthesis. .