Balloon dilation assembly with AV node/HIS bundle sensing-stimulation system

Abstract

A balloon dilation assembly configured to be used for performing balloon valvuloplasty in order to dilate a stenotic heart valve, in particular a stenotic aortic valve. The assembly comprises at least three outer balloons (12), (13), (14) evenly arranged in a circle around a central balloon (11) and fixed to the central balloon, and comprises a further outer balloon (15) which is shorter in length compared with balloons (11), (12), (13), (14) and which is not fixed to the central balloon, whereby each balloon has a separate filling tube (1), (2), (3), (4), (5) used for inflating each balloon separately, characterized in that the short outer balloon (15) is equipped with a sensing and/or stimulation system comprising an electrical pole (21).

Claims

1. A balloon dilation assembly configured to be used in balloon valvuloplasty comprising: at least three outer balloons evenly arranged in a circle around a central balloon and fixed to the central balloon, and including a further outer balloon which is shorter in length compared with the at least three outer balloons and which is not fixed to the central balloon, whereby each balloon has a separate filling tube used for inflating each balloon separately, wherein the shorter outer balloon is equipped with a sensing and/or stimulation system that includes an electrical pole.

2. The balloon dilation assembly according to claim 1, having three to six outer balloons.

3. The balloon dilation assembly according to claim 1, wherein the at least three outer balloons have the same length.

4. The balloon dilation assembly according to claim 1, wherein one of the outer balloons is an arrangement of two balloons arranged one after the other and having separate filling tubes which are movable into each other, whereby the proximal one of the two arranged balloons carries the electrode pole.

5. The balloon dilation assembly according to claim 4, wherein the two arranged balloons are movable together or relative to each other.

6. The balloon dilation assembly according to claim 1, wherein one of the outer balloons is an arrangement of two balloons arranged one after the other and having separate filling tubes which are movable into each other, and the assembly further comprises an insulated coil with a blanc space in its middle acting as pole, the coil running along the two arranged balloons.

7. The balloon dilation assembly according to claim 6, wherein the two arranged balloons are movable together or relative to each other.

8. The balloon dilation assembly according to claim 1, further comprising at least one RF ablation pole.

9. The balloon dilation assembly according to claim 1, further having a protective element in form of a filter or an occluder, placed in the area of the aortic arch in a use position.

Description

DETAILED DESCRIPTION OF THE FIGURES

(1) The following figures show the inventive balloon dilation assembly in more detail.

(2) The reference signs are as follows:

(3) 1 filling tube of the central balloon

(4) 2, 3, 4, 5, filling tubes of the outer balloons

(5) 6 flow channel

(6) 7 guide wire

(7) 8 AV node/HIS bundle

(8) 9 self-expandable filter

(9) 11. central balloon

(10) 12, 13, 14 outer balloons

(11) 15 short outer balloon “sensing balloon”

(12) 16 distally placed outer balloon

(13) 17 proximally placed outer balloon (“sensing balloon”)

(14) 18 delivery sheath

(15) 19 left ventricle

(16) 20 aortic valve

(17) 21 sensing and/or stimulation pole

(18) 22 RF-ablation pole

(19) AV Atrioventricular node

(20) HIS HIS bundle

(21) FIG. 1 illustrates a schematic view of the heart with the balloon dilatation assembly according to the invention being placed. The assembly is used in a transapical approach of performing aortic balloon valvuloplasty. Using guide wire (7) the balloon dilation assembly has been guided through the left ventricle (19), fed to the aortic valve (20) and further to the aortic arch. FIG. 1 shows the assembly with inflated balloons.

(22) The AV node/HIS bundle (8) is marked with a black dot with left and right branches. The AV node/HIS bundle is located in the heart septum beneath the aortic valve.

(23) The central balloon (11) and the three outer balloons (12, 13, 14) which are evenly arranged around the central balloon are placed in the area of the aortic valve (20) and are configured to dilate the aortic valve. The outer balloon (14) is only seen in the cross sectional view of FIG. 2.

(24) The outer balloon (15) is shorter in length compared to the outer balloons (12, 13 and 14).

(25) The outer balloon (15) carries an electrode pole (21) at the outer balloon skin. The electrical lead to the cardiac monitoring device and/or stimulation device is guided inside the filling tube or outside along the filling tube of the “sensing balloon” (15). The electrical lead to the monitor is not shown in the drawing. Balloon (15) with pole (21) functions as “sensing balloon”. Each balloon can be separately filled with a liquid or a gas via its filling tube (1, 2, 3, 4, 5) and is thus inflated. Due to the individual filling of each balloon, the pressure in each balloon can vary. The “sensing balloon” with the pole is rather weakly inflated, certainly not inflated to full pressure and is configured to contact the area of the AV node/HIS bundle without any pressure in order to monitor a sensing signal of the AV node/HIS bundle or to generate a stimulation signal of the AV node/HIS bundle. If a sensing signal is received, the dilation assembly is correctly placed. Due to the short distance between the myocardium entrance and the aortic valve it is easy to place the “sensing balloon” and thus the whole assembly in the right position.

(26) When the sensing is completed balloon (15) is moved out of the critical AV node/His bundle area.

(27) The filling tubes (1, 2, 3, 4, 5) are coming out of the delivery sheath (18). Through the filling tube to the central balloon the guide wire (7) is drawn. Each outer balloon (12, 13, 14) is fixed to the central balloon (11). The “sensing balloon” (15) is not fixed and is thus movable. The balloon dilatation assembly is placed using guide wire (7). Flow channel run lengthwise along the balloons between each pair of two adjacent balloons.

(28) A self-expandable braided filter (9) made of nitinol is shown in its expanded configuration. The braiding is placed in the upper part of the guide wire (7) in the area of the aortic arch and is helpful to catch atherosclerotic plaques during the balloon valvuloplasty procedure.

(29) FIG. 2 is a cross sectional view of the inserted assembly as shown in FIG. 1. The outer balloons (12, 13, 14) are arranged symmetrically in a circle around the central balloon (11). Flow channels (6) are generated between each pair of two adjacent outer balloons. The short outer balloon (15) which is the “sensing balloon” lies next to the AV node/HIS bundle (8).

(30) FIG. 3 illustrates a schematic view of the heart as FIG. 1 does. The reference signs of FIG. 1 are not repeated in the drawing of FIG. 3 to avoid a confusingly large number of signs. A balloon dilatation assembly as shown in FIG. 1 has been inserted. In contrast to the balloon dilation assembly illustrated in FIG. 1 one of the outer balloons consists of two balloons arranged one after the other. Balloon (16) is distally placed; balloon (17) is proximally placed. Balloon (16) is used to dilate the aortic valve like the other outer balloons. Balloon (16) and balloon (17) each have separate filling tubes which are movable into each other. An insulated coil with a blanc space in the middle acts as electrical pole (21). The insulated coil runs along balloon (16) and (17) facing to the AV node/HIS bundle area (8). Thus, balloon (17) functions via pole (21) as “sensing balloon”. Balloon (16) and (17) are not fixed to the central balloon (11). Moving balloon (16) and (17) allows to move pole (21) in order to reach the correct sensing position.

(31) FIG. 4 corresponds to an assembly shown in FIG. 3. Balloon (17) carries pole (21) and functions as “sensing balloon”. Pole (21) may be in form of a coated electrical conductive material ring.

(32) FIG. 5 corresponds to an assembly shown in FIG. 4. In contrary to the assembly described in FIG. 4 further poles (22) may be used for RF ablation of the heart valve area.

(33) FIG. 6 illustrates a schematic view of the heart with the balloon dilatation assembly according to FIG. 5 being placed in a transfemoral approach of performing aortic balloon valvuloplasty. Using guide wire (7) the assembly has been guided through the femoral artery, fed to the aortic valve and further to the left ventricle.