WO2012165429A1

WO2012165429A1 - Cannula and assisted circulation device

Info

Publication number: WO2012165429A1
Application number: PCT/JP2012/063764
Authority: WO
Inventors: 西村　隆; 小林　進; 俊介菊本; 圭祐平間
Original assignee: 国立大学法人東京大学; ニプロ株式会社
Priority date: 2011-06-01
Filing date: 2012-05-29
Publication date: 2012-12-06
Also published as: JP2012249732A

Abstract

The invention is configured in a tube shape that has a tip (31) and base ends (32, 33). Towards the tip (31), a first opening (11) and a second opening (21) are provided. The cannula (100), which positions the first opening (11) inside the aorta (66) and positions the second opening (21) inside a ventricle (64) when the tip (31) is pierced directly in a heart (60) to perform assisted circulation, is equipped with: a first lumen (10) that comprises the first opening (11) and extends from the first opening (11) to the base end (32); and a second lumen (20) that comprises the second opening (21), which is formed in a region closer to the base end (33) than the first opening (11), and extends side-by-side with the first lumen (10) from the second opening (21) towards the base end (33). The cannula (100) is designed to improve circulation efficiency in assisted circulation of blood.

Description

Cannula and auxiliary circulation device

The present invention relates to a cannula used for blood auxiliary circulation and an auxiliary circulation device, and more particularly to a cannula having a so-called double lumen structure and an auxiliary circulation device including the cannula.

As disclosed in Japanese Patent Laid-Open No. 05-146513 (Patent Document 1), a cannula used for the treatment of cardiac dysfunction is known. As disclosed in JP-A-11-0000402 (Patent Document 2), a catheter having a so-called double lumen structure is known.

As disclosed in Japanese Patent Laid-Open No. 2007-236819 (Patent Document 3), the Seldinger method is known as one of methods for inserting a catheter into a blood vessel. As disclosed in JP-A-07-136247 (Patent Document 4), a centrifugal pump for blood transportation is known.

As disclosed in Japanese Translation of PCT International Publication No. 2002-510216 (Patent Document 5), a cardiac assist system that transfers blood from a ventricle to an artery through a lumen of a cannula is known.

Japanese Patent Laid-Open No. 05-146513 JP 11-000402 A JP 2007-236819 A Japanese Patent Application Laid-Open No. 07-136247 Japanese translation of PCT publication No. 2002-510216

An object of the present invention is to provide a cannula and an auxiliary circulation device capable of improving the circulation efficiency in the auxiliary blood circulation.

The cannula according to the present invention is configured in a tubular shape having a distal end and a proximal end, and a first opening and a second opening are provided on the distal end side, and the distal end directly punctures the heart for auxiliary circulation. In this state, the first opening is located in the aorta, and the second opening is a cannula located in the ventricle, including the first opening, and from the first opening to the base. A first lumen extending toward the end; and the second opening formed at a portion closer to the base end than the first opening, and from the second opening toward the base end. A second lumen extending alongside the first lumen.

Preferably, the distance between the first opening and the second opening is 20 mm to 180 mm.

Preferably, in a cross-sectional view orthogonal to a direction in which the first lumen and the second lumen extend, the first opening is formed in a circular shape, an elliptical shape, or a semicircular shape, and the second opening The part is formed in a crescent, elliptical or semicircular shape.

The above-described cannula according to the present invention preferably further includes a guide wire and a stylet inserted through the first lumen and guided by the guide wire.

An auxiliary circulation device according to the present invention includes the cannula according to the present invention, a blood pump, and tubes connected to the cannula and the blood pump, respectively, and the blood pump passes through the tube and the first lumen. Is set to a positive pressure, and the blood pump sets the second lumen to a negative pressure, whereby the auxiliary circulation is performed.

According to the present invention, it is possible to obtain a cannula and an auxiliary circulation device capable of improving the circulation efficiency in the auxiliary blood circulation.

It is a perspective view which shows the external appearance of the cannula in embodiment. FIG. 2 is a cross-sectional view taken along the line II-II in FIG. FIG. 3 is a cross-sectional view taken along the line III-III in FIG. FIG. 4 is a cross-sectional view taken along line IV-IV in FIG. 1. It is sectional drawing which shows an example of the assembly of the cannula in embodiment. It is a figure which shows typically the auxiliary | assistant circulation apparatus in embodiment, and its usage condition. It is a perspective view which shows the cannula in the 1st modification of embodiment. FIG. 8 is a cross-sectional view taken along the line VIII-VIII in FIG. It is a perspective view which shows the cannula in the 2nd modification of embodiment. FIG. 10 is a cross-sectional view taken along line XX in FIG. 9. It is a perspective view which shows the cannula in the 3rd modification of embodiment. FIG. 12 is a cross-sectional view taken along the line XII-XII in FIG. FIG. 12 is a cross-sectional view taken along the line XIII-XIII in FIG. It is a perspective view which shows the cannula in the 4th modification of embodiment. It is a perspective view which shows the cannula in the 5th modification of embodiment.

Embodiments according to the present invention will be described below with reference to the drawings. In the description of the embodiments, when referring to the number, amount, and the like, the scope of the present invention is not necessarily limited to the number, amount, or the like unless otherwise specified. In the description of the embodiments, the same parts and corresponding parts are denoted by the same reference numerals, and redundant description may not be repeated. Unless there is a restriction | limiting in particular, it is planned from the beginning to use the structure shown in embodiment combining suitably.

[Cannula 100]
The cannula 100 according to the embodiment will be described with reference to FIGS. FIG. 1 is a perspective view showing the external appearance of the cannula 100. 2 is a cross-sectional view taken along the line II-II in FIG. 3 is a cross-sectional view taken along line III-III in FIG. 4 is a cross-sectional view taken along the line IV-IV in FIG.

As shown in FIGS. 1 and 2, the cannula 100 is formed of a tubular member. Examples of the material of the member constituting the cannula 100 include polyurethane, polycarbonate, Teflon (registered trademark), and nylon. The cannula 100 has a distal end 31 at one end (left side in FIG. 2) and a

proximal end

32, 33 at the other end (right side in FIG. 2). For the portion from the distal end 31 of the cannula 100 to the opening 21 of the second lumen 20 described later, it is preferable to use a flexible material such as polyurethane so as not to damage the insertion site when puncturing. As for, it is preferable to use a hard material such as polycarbonate so that it can be easily connected to the tube.

The cannula 100 has a so-called double lumen structure. This double lumen structure includes a first lumen forming portion 12 and a second lumen forming portion 22. The first lumen forming part 12 forms the first lumen 10 therein. The second lumen forming portion 22 is integrally provided alongside the first lumen forming portion 12 outside the first lumen forming portion 12. The second lumen forming part 22 forms the second lumen 20 therein.

The first lumen forming portion 12 is formed of a tubular member and extends between the distal end 31 and the proximal end 32. The opening 11 (first opening) formed at the distal end 31 communicates with the inside of the first lumen 10. The opening 13 (see FIG. 2) formed in the proximal end 32 is also in communication with the inside of the first lumen 10. Since the stylet 40 and the guide wire 45 are inserted by the Seldinger method to be described later, the first lumen 10 is preferably provided in a straight line without a bent portion so as to facilitate insertion.

The second lumen forming portion 22 extends between the proximal end 33 and the middle portion of the outer surface closer to the proximal end 32 than the distal end 31 of the first lumen forming portion 12. The opening 21 (second opening) formed in the middle portion communicates with the inside of the second lumen 20. An opening 23 (see FIG. 2) formed in the proximal end 33 is also in communication with the inside of the second lumen 20. The first lumen 10 and the second lumen 20 do not communicate with each other and are spatially independent.

The distance between the opening 11 of the first lumen 10 and the opening 21 of the second lumen 20 is, for example, 20 mm to 180 mm. Here, the distance between the opening 11 and the opening 21 is the most distal end of the opening 11 and the opening 21 when the opening 21 extends in the longitudinal direction as in the present embodiment. This means that the distance to the side is 20 mm at the shortest and the distance between the opening 11 and the most proximal side of the opening 21 is 180 mm at the longest. The range of 20 mm to 180 mm corresponds to the distance between the aorta and the ventricle taking into account a newborn to a large adult when the cannula 100 is punctured into the heart.

As shown in FIGS. 3 and 4, the cross-sectional shape of the first lumen 10 (the shape in a cross-sectional view orthogonal to the direction in which the first lumen 10 and the second lumen 20 extend) is the stylus to the cannula 100. In order to facilitate the insertion of the let 40 and the insertion of the cannula 100 into the heart, a circular shape is preferable, but an elliptical shape or a semicircular shape may be used. The inner diameter of the first lumen 10 is, for example, 3 mm to 10 mm. The cross-sectional shape of the second lumen 20 may be a crescent shape, an elliptical shape, a semicircular shape, or the like according to the shapes of the opening 11 and the first lumen 10. The second lumen 20 is curved along the outer periphery of the first lumen 10 while being spaced from the first lumen 10. Both ends of the second lumen 20 in the circumferential direction are rounded.

FIG. 5 shows the cannula 100 when the Seldinger method is used. When the Seldinger method is used, the stylet 40 and the guide wire 45 are inserted into the first lumen 10 of the cannula 100.

Referring to FIG. 6, the cannula 100 can be used in an assembled state as the auxiliary circulation device 200. As the auxiliary circulation device 200, a tube 42 is connected to the proximal end 32 of the cannula 100. The tube 42 is connected to a centrifugal blood pump 44. With this connection, the first lumen 10 of the cannula 100 communicates with the blood pump 44.

Similarly, a tube 43 is connected to the proximal end 33 of the cannula 100. The tube 43 is also connected to the blood pump 44. With this connection, the second lumen 20 of the cannula 100 communicates with the blood pump 44. A blood circulation circuit including the cannula 100, the tube 43, the blood pump 44, the tube 42, and the cannula 100 is configured.

A case where the cannula 100 is punctured into the heart 60 using the Seldinger method will be described. First, a Seldinger needle (not shown) consisting of an outer tube and a puncture needle that penetrates the outer tube is inserted into the heart from the intercostal space, the puncture needle is removed, and a guide wire 45 is inserted into the outer tube from the rear end. To do. Then, after removing the outer tube, the stylet 40 and cannula 100 are inserted along the guide wire 45 (see FIG. 5). Thereafter, the guide wire 45 is removed.

The cannula 100 is directly punctured into the heart 60 percutaneously. The cannula 100 is designed so that the opening 21 is located in the left ventricle 64 when the opening 11 passes through the aortic valve 65 and is located in the ascending aorta 66.

The blood supply and blood removal of the auxiliary circulation performed by the auxiliary circulation apparatus 200 will be described. Blood from the right pulmonary vein 61 and the left pulmonary vein 62 reaches the left ventricle 64 via the left atrium 63. Blood is taken into the second lumen 20 from the left ventricle 64 through the opening 21 (blood removal). The blood passes through the cannula 100, the tube 43, the blood pump 44, the tube 42, and the first lumen 10.

Blood is sequentially fed from the opening 11 to the ascending aorta 66 and the aortic arch 67 (blood feeding). The cannula 100 may be designed so that a portion of the blood in the left ventricle 64 flows directly into the ascending aorta 66 to prevent thrombus in the left ventricle 64. As described above, the cannula 100 and the auxiliary circulation device 200 including the cannula 100 can be effectively used for the auxiliary circulation of a patient such as myocardial infarction or dilated cardiomyopathy.

In the auxiliary circulation described in Japanese Patent Laid-Open No. 5-146513 (Patent Document 1) described at the beginning, a cannula is inserted from the femoral artery and its tip is placed in the heart through the descending aorta. In this configuration, since the blood flow path is likely to be long and the tube diameter cannot be increased, it is difficult to ensure a sufficient blood flow rate.

On the other hand, the cannula 100 in the present embodiment can be directly punctured from the intercostal space to the heart, so that the blood flow path can be shortened and the tube diameter is increased. It is possible to ensure a sufficient flow rate.

In the auxiliary circulation in the Japanese translations of PCT publication No. 2002-510216 (patent document 5) explained at the beginning, the cannula used does not have a double lumen structure. Therefore, two cannulas for blood delivery and blood removal must be inserted into the body.

On the other hand, since the cannula 100 in the present embodiment has a double lumen structure, it is possible to simultaneously perform blood feeding and blood removal.

Therefore, according to the cannula 100 and the auxiliary circulation device 200 in the present embodiment, it is possible to improve the circulation efficiency in the auxiliary blood circulation. Moreover, since auxiliary circulation can be performed by inserting one cannula, it is possible to reduce the time required for the procedure. Furthermore, since there is only one heart perforation (wound), invasion to the body is reduced.

[First Modification]
With reference to FIG. 7 and FIG. 8, the cannula 100A in the 1st modification of embodiment is demonstrated. FIG. 7 is a perspective view showing the cannula 100A. 8 is a cross-sectional view taken along the line VIII-VIII in FIG.

The cannula 100A in the first modified example has an opening 21A instead of the opening 21 (see FIG. 1) of the cannula 100 (see FIG. 1) in the above-described embodiment. The opening 21A is a circular hole, and its diameter is, for example, 1 mm to 7 mm. Also with this configuration, the same effects as those of the above-described embodiment can be obtained.

[Second Modification]
With reference to FIG. 9 and FIG. 10, the cannula 100B in the 2nd modification of embodiment is demonstrated. FIG. 9 is a perspective view showing the cannula 100B. 10 is a cross-sectional view taken along line XX in FIG.

The cannula 100B in the second modification has an opening 21B instead of the opening 21 (see FIG. 1) of the cannula 100 (see FIG. 1) in the above-described embodiment. The opening 21B is composed of four circular holes 21B1 to 21B4. The diameters of the holes 21B1 to 21B4 are, for example, 1 mm to 7 mm. Also with this configuration, the same effects as those of the above-described embodiment can be obtained.

[Third Modification]
A cannula 100C according to a third modification of the embodiment will be described with reference to FIGS. FIG. 11 is a perspective view showing the cannula 100C. 12 is a cross-sectional view taken along line XII-XII in FIG. 13 is a cross-sectional view taken along line XIII-XIII in FIG.

The cannula 100C in the third modification has an opening 21C instead of the opening 21 (see FIG. 1) of the cannula 100 (see FIG. 1) in the above-described embodiment. The opening 21C is composed of five circular holes 21C1 to 21C5. The diameter of the holes 21C1 to 21C5 is, for example, 1 mm to 7 mm. The holes 21C1 to 21C3 are arranged on the same straight line at intervals, and the holes 21C4 and 21C5 are arranged symmetrically across the straight line. Thus, by providing the holes 21C4 and 21C5 on both sides, it is possible to prevent the blood from staying and effectively prevent the formation of a thrombus. An angle θ (see FIG. 13) on the circumference between the holes 21C4 and 21C5 is, for example, 60 ° to 180 °, and more preferably 90 ° to 120 °. Also with this configuration, the same effects as those of the above-described embodiment can be obtained.

[Fourth Modification]
With reference to FIG. 14, a cannula 100D according to a fourth modification of the embodiment will be described. The cannula 100D has an opening 21D instead of the opening 21 (see FIG. 1) of the cannula 100 (see FIG. 1) in the above-described embodiment. The opening 21D is composed of four circular holes 21D1 to 21D4. The diameters of the holes 21D1 to 21D4 are provided so as to gradually increase from the distal end side toward the proximal end side. Also with this configuration, the same effects as those of the above-described embodiment can be obtained.

[Fifth Modification]
With reference to FIG. 15, the cannula 100E in the 5th modification of embodiment is demonstrated. The cannula 100E has an opening 21E instead of the opening 21 (see FIG. 1) of the cannula 100 (see FIG. 1) in the above-described embodiment. The opening 21E is configured in an elliptical shape so as to gradually increase from the distal end side toward the proximal end side. Also with this configuration, the same effects as those of the above-described embodiment can be obtained.

As mentioned above, although embodiment based on this invention was described, embodiment disclosed this time is an illustration and restrictive at no points. The technical scope of the present invention is defined by the terms of the claims, and is intended to include any modifications within the scope and meaning equivalent to the terms of the claims.

10 1st lumen, 11 opening (first opening), 12 1st lumen forming portion, 13, 23 opening, 20 2nd lumen, 21, 21A, 21B, 21C, 21D, 21E opening ( 2nd opening), 21B1 to 21B4, 21C1 to 21C5, 21D1 to 21D4 hole, 22 second lumen forming part, 31 distal end, 32, 33 proximal end, 40 stylet, 42, 43 tube, 44 blood pump, 45 Guide wire, 60 heart, 61 right pulmonary vein, 62 left pulmonary vein, 63 left atrium, 64 left ventricle, 65 aortic valve, 66 ascending aorta, 67 aortic arch, 100, 100A, 100B, 100C, 100D, 100E cannula, 200 Auxiliary circulation device.

Claims

In order to perform auxiliary circulation, the first opening (11) and the second opening (21) are provided on the distal end side and are configured in a tubular shape having a distal end (31) and a proximal end (32, 33). When the tip is directly punctured into the heart (60), the first opening is located in the aorta (66) and the second opening is a cannula (100) located in the ventricle (64). There,
A first lumen (10) including the first opening (11) and extending from the first opening toward the proximal end;
It includes the second opening (21) formed at a portion closer to the proximal end than the first opening, and extends alongside the first lumen from the second opening toward the proximal end. A second lumen (20) that comprises:
Cannula.
The distance between the first opening (11) and the second opening (21) is 20 mm to 180 mm.
The cannula of claim 1.
In a cross-sectional view orthogonal to the direction in which the first lumen (10) and the second lumen (20) extend, the first opening (11) is formed in a circular shape, an elliptical shape, or a semicircular shape. The second opening (21) is formed in a crescent, elliptical or semicircular shape,
The cannula according to claim 1 or 2.
A guide wire (45);
A stylet (40) inserted through the first lumen and guided by the guide wire;
Further comprising
The cannula according to any one of claims 1 to 3.
The cannula according to any one of claims 1 to 4,
A blood pump (44);
Tubes (42, 43) respectively connected to the cannula and the blood pump;
The auxiliary circulation is performed by the blood pump setting the first lumen (10) to a positive pressure through the tube and the blood pump setting the second lumen (20) to a negative pressure.
Auxiliary circulation device (200).