ENDOVASCULAR MOBILE BALLOON SUPPORT CATHETER

Abstract

The invention refers to endovascular catheters and methods useful to endovascular surgery. In particular, it refers to support catheters with balloons that are used for the placement or the forwarding of the guidewire through demanding tortuosity and important vascular stenoses in cases where the guidewire needs the best possible backup support of the catheter. This is achieved with the development of an endovascular support catheter (1) with a mobile balloon (22), which has the ability to move along the body of the catheter (2), at its distal part. The movement of the balloon (22) is achieved with the use of two mobile external rings (13) and (18), one inner wire circuit (23), (24), and one control handle (13) (17) which is found at the proximal end of the device (1). The mobile balloon allows the catheter to move inside the vessel even when it is inflated and basically anchored within the vessel.

Claims

1. The endovascular mobile balloon support catheter consists of: a longitudinal cylindrical catheter (2), partly made of radiopaque material, incorporating six communicating parts including a central cylindrical part (3), where we find the opening of the lumen (28) through which the guidewire (25) passes, a cylindrical part (6) with the central groove (5) at the proximal part of the catheter, a cylindrical part without a groove (7) at the central section of the catheter, a second cylindrical part (10) with the peripheral groove (8) near its peripheral end, a second cylindrical part without a groove (11) and a specially designed tip (12) at the end of the longitudinal cylindrical catheter (2). The longitudinal cylindrical catheter (2) includes three inner lumens (26), (27), (28), which are parallel to one another and to the central axis of the longitudinal cylindrical catheter (2). The inner lumen (26) is exposed in two equal parts, groove (5) proximally and groove (8) distally. The inner lumens (26) and (27) are connected to the central connection (4) at the central section of the longitudinal cylindrical catheter (2) and to the peripheral connection (9) distally. The connections (4) and (9) are curved cylindrical lumens that connect the inner lumens (26) and (27), completing a closed circuit inside the longitudinal cylindrical catheter (2). Two mobile rings (13) and (18) are attached to the longitudinal cylindrical catheter (2), one at its proximal and one at its distal end, and can move along the catheter in both directions, covering a range of movement approximately equal to the length of grooves (5) and (8). The movement of the mobile rings (13) and (18) is depended, since they always move in the same direction, covering the same distance and maintaining a fixed distance between them. The mobile rings (13) and (18) can only move along the longitudinal cylindrical catheter (2), but cannot rotate around it. This is achieved with the placement of their cylindrical parts (14) and (19) into grooves (5) and (8) respectively, into which they are fitted. The cylindrical parts (14) and (19) are fitted inside the mobile rings (13) and (18) respectively. An elastomeric balloon (22) is loaded on the low profile mobile ring (18). The mobile ring (13) includes the liquid regulation system (17) through which the elastomeric balloon (22) is inflated. The liquid regulation system (17) is attached to the opening (16) of the mobile ring (13). During a surgical procedure, the longitudinal cylindrical catheter (2) is inserted into the patient's body through its specially designed tip (12) up until the cylindrical part without groove (7). The cylindrical part (6) and the cylindrical part (3) are always outside the patient's body, accessible to the surgeon.

2. According to claim 1, the endovascular mobile balloon support catheter is characterized by the fact that the mobile rings (13) and (18) are interconnected in a closed circuit, with the hollow wire (23) on one side and the synthetic cord (24) on the other side. Specifically, the mobile rings (13) and (18) are connected to the inner wire circuit of the longitudinal cylindrical catheter (2) via their cylindrical parts (14) and (19) respectively, which are directly connected to the hollow wire (23) on one side and the synthetic cord (24) on the other side. The cylindrical parts (14) and (19) are fitted within the mobile rings (13) and (18) respectively, in a way that the openings of their inner lumens (15) and (20) communicate with the openings (16) and (21) of the mobile rings (13) and (19). The hollow wire (23) can only move inside the inner lumen (26) when the circuit is in motion, while the synthetic cord (24) can move inside both inner lumens (26) and (27), as well as inside the central and peripheral connections (4) and (9) of the inner lumens (26) and (27).

3. According to claim 2, the endovascular mobile balloon support catheter is characterized by the fact that the elastomeric balloon (22) is inflated with the insertion of liquid in the liquid regulation system (17), crossing the opening (16) of the mobile ring (13) with which it is connected, and going through lumen (15) of the cylindrical part (14) and the lumen of the hollow wire (23), it reaches lumen (20) of the cylindrical part (19) where it goes through the opening (21) of the low profile mobile ring and enters the elastomeric balloon (22).

4. According to claim 2, the endovascular mobile balloon support catheter is characterized by the fact that when we move the mobile ring (13) by hand along the longitudinal cylindrical catheter (2), the low profile mobile ring (18) and the elastomeric balloon (22) loaded on it also move simultaneously towards the same direction and for the same distance. This is achieved with the clockwise or counterclockwise motion of the whole circuit that consists of the mobile rings (13) and (18) with their cylindrical parts (14) and (19), as well as with the hollow wire (23) and the synthetic cord (24). In this way, the force applied by the human hand on the cylindrical mobile ring (13), is transferred virtually unchanged to the cylindrical mobile ring (18), which it moves.

5. According to claim 1, the endovascular mobile balloon support catheter is characterized by the fact that the elastomeric balloon (22) loaded onto the low profile mobile ring (18) is soft and atraumatic and expands when inflated to cover calibers of a wide range of vessels or other lumens of the human body, without damaging the vessel walls.

6. According to claim 1, the endovascular mobile balloon support catheter is characterized by the fact that the inflated elastomeric balloon (22) loaded onto the low profile mobile ring (18) basically anchors the peripheral part of the cylindrical catheter (2) within the vessel or other lumen of the human body, since the inflated elastomeric balloon (22) is anchored within the lumen without causing any trauma, providing sufficient backup support to the guidewire (25) during the endovascular procedure so as to facilitate its crossing through anatomically demanding tortuosity and important stenoses.

7. According to claim 6, the inflated and anchored elastomeric balloon (22) which is loaded onto the low profile peripheral mobile ring (18), is characterized by the fact that, when inflated and anchored within the vessel or other lumen of the human body, it translates its movement towards the longitudinal cylindrical catheter (2) into a movement of the longitudinal cylindrical catheter (2) towards the anchored elastomeric balloon (22) within the vessel or other lumen of the human body and thus, into a movement of the cylindrical catheter (2) towards the vessel or other lumen of the human body. In this way, the longitudinal cylindrical catheter (2) acquires: a. the maximum pushability, b. the maximum crossability through a vascular lesion, and c. the maximum trackability on a guidewire through tortuosity, since the propulsive force is in fact applied near its tip.

8. According to claim 4, the endovascular mobile balloon support catheter is characterized by the fact that the mobile rings (13) and (18) are connected to each other in a closed circuit, and by moving the cylindrical ring (13) by hand along the longitudinal cylindrical catheter (2), the mobile ring (18) moves simultaneously towards the same direction and covers the same distance. By following the same methodology, the present invention can be modified with the removal of the elastomeric balloon from the mobile ring (18), so that the mobile ring can be loaded with other endovascular tools, such as atherectomy blades, or facilitate the insertion of materials within the vessel.

Description

[0024] In the figures that follow, the corresponding reference numbers refer to the same parts, from all different angles. The figures are not drawn necessarily in scale. Instead, the presentation of the principles of the invention has been emphasized. The figures represent typical applications of the invention and should not therefore be considered limiting as to the range of applications. The invention will be described and explained with additional details and accuracy with the use of the attached figures.

[0025] FIG. 1 and FIG. 2 are: the detailed illustration of the endovascular mobile balloon support catheter and the illustration of the inner wire circuit that shows the dependent movement of the balloon and the catheter handle button along the catheter to the simultaneous movement of the inner wire circuit, according to the general principles of the invention.

[0026] FIG. 3 illustrates the non-mobile components of the endovascular mobile balloon support catheter with the simultaneous representation of their inner lumens. We should note that for the tracking of the device during the endovascular process, some of the catheter's parts are constructed by radiopaque material.

[0027] FIG. 4 illustratesin vertical sectionthe mobile components of the endovascular mobile balloon support catheter. Specifically, we can see the mobile ring which is used for the movement and the inflation of the mobile balloon along with the system of liquid regulation, the mobile balloon and the mobile ring on which the balloon is loaded, as well as the inner wire circuit that is used to control the movement and the inflation of the balloon.

[0028] FIG. 5 illustrates the central section of the endovascular mobile balloon support catheter at an angle. Specifically we can see the moving ring which is used for the movement and the inflation of the mobile balloon along with the system of liquid regulation, part of the guidewire and part of the inner wire circuit that is used to control the movement and the inflation of the balloon. There is also a separate figure of the cylindrical part that is attached to the mobile ring, connecting the mobile ring and the system of liquid regulation that inflates the ring to the inner wire system.

[0029] FIG. 6 illustrates the central part of the endovascular mobile balloon support catheter at an angle different to the one of FIG. 5. Specifically, it depicts the mobile ring which is used for the movement and the inflation of the mobile balloon along with the system of liquid regulation, part of the guidewire, and part of the inner wire circuit that is used to control the movement and the inflation of the balloon. The separate figure represents the cylindrical part that is attached to the mobile ring connecting the mobile ring and the system of liquid regulation that inflates the ring to the inner wire system.

[0030] FIG. 7 is an illustration of the peripheral part of the endovascular mobile balloon support catheter at an angle. Specifically, it illustrates the mobile ring and the balloon loaded on it, the peripheral groove of the cylindrical catheter, part of the guidewire and part of the inner wire circuit that is used to control the movement and the inflation of the balloon. On a separate illustration we can see the cylindrical part attached to the mobile balloon ring and connects it to the inner wire circuit.

[0031] FIG. 8 is an illustration of the peripheral part of the endovascular mobile balloon support catheter at an angle different to the one of FIG. 7. Specifically, it illustrates the mobile ring and the balloon loaded on it, part of the guidewire as well as part of the inner wire circuit that is used to control the movement and the inflation of the balloon. On a separate illustration we can see the cylindrical part attached to the mobile balloon ring and connects it to the inner wire circuit.

[0032] FIG. 9 is an illustration of the point of insertion of the guidewire to the central part of the catheter.

[0033] FIG. 10 is an illustration of the specially designed tip at the distal end of the catheter.

[0034] FIG. 11 is an illustration of the mobile ring that controls the balloon and of the mobile ring on which the balloon of the support catheter is loaded. There are further illustrations of the cylindrical parts that are attached inside the mobile rings and connect them to the inner wire circuit.

[0035] It is understood that the figures are diagrammatic and schematic representation of exemplary applications of the device and are not limiting as to the range of applications. They are also not drawn in scale.

[0036] The present device generally refers to endovascular catheters and methods of using them. More specifically, the present device relates to endovascular balloon catheters and endovascular mobile balloon support catheters that facilitate the exact positioning and crossing of a guidewire through calcified and long lesions, significant tortuous vasculature, chronic blockages, bifurcation lesions and generally help in all cases where the guidewire needs the maximal possible backup support of the catheter. It should be noted that this description is only used as an example and that the present endovascular mobile balloon support catheter can have several applications in the treatment of pathologies in various lumens of the human body, including the ureter and urethra, the cholangi, the esophagus and the tracheobronchial tree.

[0037] The endovascular mobile balloon support catheter (1), as illustrated in FIG. 1 and in FIG. 2, has been designed for endoluminal crossing through a vessel and for this reason it can acquire the size that will facilitate this crossing, depending on the vessel in question. For example, for use in a coronary artery, the catheter can have an outside diameter of approximately 1.2 to 1.7 mm and an inside diameter of approximately 0.8 to 1.2 mm, even though these dimensions are purely indicative. For instance, the use of the catheter in non-coronary vessels demands catheter dimensions of a greater scale than the one used for a coronary artery.

[0038] As illustrated in FIG. 1 and FIG. 2, the endovascular mobile balloon support catheter (1) consists of a longitudinal cylindrical catheter (2), partly made of radiopaque material FIG. 3, on which two mobile rings (13) are loaded FIG. 5 and FIGS. 6 and (18) FIG. 7 and FIG. 8. The mobile rings (13) and (18) only move along the longitudinal cylindrical catheter (2), without rotating around it. The movement of the mobile rings (13) and (18), is co-dependent and they always move towards the same direction in relation to the longitudinal cylindrical catheter (2), maintaining their in-between distance fixed. This is achieved because of the fact that they form parts of an inner wire circuit, as illustrated in FIG. 1 and FIG. 2. The inner wire system consists of the hollow wire (23) and the synthetic cord (24) that are connected to the mobile rings (13) and (18) via their cylindrical parts (14) and (19) FIG. 11. The mobile ring (13) has an opening (16) FIG. 11, on which the system of liquid regulation that inflates the balloon (17) is affixed. The mobile balloon (22) is loaded to the low profile mobile ring (18).

[0039] As described further on, the invention consists of mobile and non mobile components.

Non Mobile Components

[0040] As illustrated in FIG. 3, FIG. 9 and in FIG. 10, the longitudinal cylindrical catheter (2) consists of six communicating parts and includes a central cylindrical part (3) FIG. 9, that includes the opening of the lumen (28), through which the guidewire (25) crosses, a cylindrical part (6) with the groove (5) at the proximal part of the catheter, a cylindrical part without a groove (7) at the central part of the catheter, a second cylindrical part (10) with the peripheral groove (8) near the distal end of the longitudinal cylindrical catheter (2), a second cylindrical part without a groove (11) and a specially designed tip (12) FIG. 10 at the very end of the longitudinal cylindrical catheter (2). During the endovascular use, the longitudinal cylindrical catheter (2) can be inserted into the human body by its specially designed tip (12), up to the cylindrical part without groove (7). The cylindrical part (6) and the central cylindrical part (3) are always outside the patient's body, accessible to the surgeon.

[0041] The central cylindrical part (3) includes part of the inner lumen (28) that runs along the whole of the longitudinal cylindrical catheter (2), starting at the beginning of the catheter and ending at the last opening of its specially designed tip (12). When the longitudinal cylindrical catheter (2) is being used, the guidewire (25) comes through the inner lumen (28).

[0042] The cylindrical part (6), includes parts of the three inner lumens (26), (27), (28), as well as the central groove (5). The central groove (5) is basically an exposed part of the lumen (26) that runs along the cylindrical part (6). The cylindrical part (6) also includes the proximal connection (4) of the lumens (26) and (27).

[0043] The cylindrical part (7) includes parts of the inner lumens (26), (27), (28) at its whole length.

[0044] The cylindrical part (10) includes parts of the inner lumens (26), (27), (28) as well as the peripheral groove (8). The peripheral groove (8) is basically an exposed part of the lumen (26) that runs along the cylindrical part (10). The cylindrical part with the groove (10) also includes the peripheral connection (9) of the lumens (26) and (27).

[0045] The cylindrical part (11) includes part of the inner lumen (28) at its whole length.

[0046] The specially designed tip (12) includes the end part of the inner lumen (28) and is cone-shaped so as to be easily guided within the vessel.

[0047] The longitudinal cylindrical catheter (2) includes from one to three inner lumens at its various parts and the two connections (4) and (9) of the two inner lumens. The connections (4) and (9) of the inner lumens (26) and (27) are curved cylindrical parts of inner lumens that connect centrally and peripherally the two parallel lumens (26) and (27). These inner lumens (26), (27) and (28) are parallel to each other and are placed within the catheter as shown in the figures of the device.

Mobile Components

[0048] As illustrated in FIG. 1, in FIG. 2, in FIG. 4, in FIG. 5 in FIG. 6, in FIG. 7, in FIG. 8 and in FIG. 11, the endovascular mobile balloon support catheter (1) also includes mobile components. The mobile components are affixed to part (6) and to part (10) of the longitudinal cylindrical catheter (2) FIG. 3. Part (6) includes the mobile ring (13) that facilitates the inflation and the control of the balloon's (22) movement of the endovascular mobile balloon support catheter (1) and part (10) that includes the low profile mobile ring (18) on which the balloon (22) of the endovascular mobile balloon support catheter (1) is loaded.

[0049] As illustrated in FIG. 11, inside the mobile ring (13), we find internally affixed the cylindrical component (14) that includes lumen (15). From one side, lumen (15) communicates with the opening (16) of the mobile ring (13) through which enters the liquid that inflates the balloon (22) of the endovascular mobile balloon support catheter (1). The length of the mobile ring (13) is such as to cover the groove (5) whenever it moves.

[0050] As illustrated in FIG. 11, inside the low profile mobile ring (18), we find internally affixed the cylindrical part (19) that includes lumen (20). From one side, lumen (20) communicates with the opening (21) of the low profile mobile ring (18) through which enters the liquid that inflates the balloon (22) of the endovascular mobile balloon support catheter (1). The length of the low profile mobile ring (18) can optionally be differentiated with the addition of an extension centrally and peripherally of the mobile ring with a significantly lower profile and greater elasticity (29), so as to cover the groove (8) whenever the balloon moves (FIG. 1, FIG. 2).

[0051] As illustrated in FIG. 4, the mobile rings (13) and (18) are connected to each other in a closed circuit with the hollow wire (23) from one side and the synthetic cord (24) at the other side. The hollow wire (23) can only move within the inner lumen (26) when the circuit is in motion, while the synthetic cord (24) can move inside both the two inner lumens (26) and (27), as well as inside the peripheral and central connection (9) and (4) of the inner lumens (26) and (27) FIG. 3. The cylindrical parts (14) and (19) FIG. 11, are fitted inside grooves (5) and (8) FIG. 3, and, therefore, the mobile rings (13) and (18) move within a maximum range delimited by the length of the two exposed parts of the inner lumen (26), i.e. the lengths of grooves (5) and (8).

[0052] This new endovascular mobile balloon support catheter (1) can have one external and one internal lining of lubricious material such as Teflon.