Percutaneous circulatory support devices including curved proximal catheters

Abstract

The percutaneous circulatory assist device includes an impeller portion having a proximal end and a rotatable impeller to force blood through the percutaneous circulatory assist device, the catheter being coupled to the proximal end and including a preformed curve.

Description

Technical Field

[0001] The present disclosure relates to a percutaneous circulatory assist device. More specifically, the present disclosure relates to a percutaneous circulatory assist device comprising a curved proximal catheter.

Background Art

[0002] Percutaneous circulatory assist devices such as blood pumps can provide temporary assistance for up to several weeks to patients with reduced cardiac function or cardiac output. Several components of such devices, including a distal cannula and a proximal catheter, are typically relatively flexible to facilitate advancement through the patient's vasculature. However, even after proper placement within the patient's body, such components can lead to instability of the device.

Summary of the Invention

[0003] In Example 1, the percutaneous circulatory assist device includes an impeller section having a proximal end and an impeller rotatable to flow blood through the percutaneous circulatory assist device. A catheter is coupled to the proximal end, the catheter comprising a pre-formed curve having a radius ranging from 50.8 mm to 6.35 mm (2.00 inches to 0.25 inches).

[0004] In Example 2, in the percutaneous circulatory assist device according to Example 1, the radius of the pre-formed curve ranges from 38.1 mm to 22.9 mm (1.50 inches to 0.90 inches). In Example 3, in the percutaneous circulatory assist device according to Example 1, the radius of the pre-formed curve ranges from 35.6 mm to 25.4 mm (1.40 inches to 1.00 inch).

[0005] In Example 4, in the percutaneous circulatory assist device according to any one of Examples 1 to 3, the pre-formed curve is offset by a distance ranging from 25.4 mm to 1.27 mm (1.00 inch to 0.05 inches) from the proximal end of the impeller section.

[0006] In Example 5, in any of the percutaneous circulatory support devices of Examples 1 to 3, the pre-formed curved portion is offset by a distance of 16.5 mm to 1.27 mm (0.65 inches to 0.05 inches) from the proximal end of the impeller portion.

[0007] In Example 6, in any of the percutaneous circulatory support devices of Examples 1 to 3, the pre-formed curved portion is offset by a distance of 14.0 mm to 3.81 mm (0.55 inches to 0.15 inches) from the proximal end of the impeller portion.

[0008] In Example 7, in any of the percutaneous circulatory support devices of Examples 1 to 6, the pre-formed curved portion has an arc length in the range of 47.8 mm to 16.0 mm (1.88 inches to 0.63 inches).

[0009] In Example 8, in any of the percutaneous circulatory support devices of Examples 1 to 6, the pre-formed curved portion has an arc length in the range of 43.2 mm to 27.9 mm (1.70 inches to 1.10 inches).

[0010] In Example 9, in any of the percutaneous circulatory support devices of Examples 1 to 6, the pre-formed curved portion has an arc length in the range of 40.6 mm to 30.5 mm (1.60 inches to 1.20 inches).

[0011] In Example 10, in a percutaneous circulatory support device according to any of Examples 1 to 9, the impeller portion further includes a distal end, and further includes a cannula coupled to the distal end, the pre-formed curved portion is a pre-formed catheter curved portion, and the cannula includes a pre-formed cannula curved portion.

[0012] In Example 11, in the percutaneous circulatory support device of Example 10, the pre-formed catheter curved portion and the pre-formed cannula curved portion are arranged in a common plane. In Example 12, the percutaneous circulatory support device includes an impeller section, which includes a proximal end and an impeller rotatable to allow blood to flow through the percutaneous circulatory support device, and a catheter coupled to the proximal end, the catheter including a pre-formed curved section having an arc length in the range of 47.8 mm to 16.0 mm (1.88 inches to 0.63 inches) and offset from the proximal end by a distance in the range of 25.4 mm to 1.27 mm (1.00 inches to 0.05 inches).

[0013] In Example 13, in the percutaneous circulatory support device of Example 12, the pre-formed curved portion has a radius in the range of 50.8 mm to 6.35 mm (2.00 inches to 0.25 inches). In Example 14, in a percutaneous circulatory support device according to any of Examples 12 to 13, the impeller portion further includes a distal end, and further includes a cannula coupled to the distal end, the pre-formed curved portion is a pre-formed catheter curved portion, and the cannula includes a pre-formed cannula curved portion.

[0014] In Example 15, in the percutaneous circulatory support device of Example 14, the pre-formed catheter curved portion and the pre-formed cannula curved portion are arranged in a common plane. In Example 16, the percutaneous circulatory support device includes an impeller section having a distal end, a proximal end, and an impeller rotatable to allow blood to flow through the percutaneous circulatory support device. A cannula is connected to the distal end, and a catheter is connected to the proximal end. The catheter has a pre-formed curved section with a radius in the range of 50.8 mm to 6.35 mm (2.00 inches to 0.25 inches).

[0015] In Example 17, in the percutaneous circulatory support device of Example 16, the radius of the pre-formed curved portion is in the range of 38.1 mm to 22.9 mm (1.50 inches to 0.90 inches). In Example 18, in the percutaneous circulatory support device of Example 16, the radius of the pre-formed curved portion is in the range of 35.6 mm to 25.4 mm (1.40 inches to 1.00 inches).

[0016] In Example 19, in the percutaneous circulatory support device of Example 16, the pre-formed curved portion is offset by a distance of 25.4 mm to 1.27 mm (1.00 inch to 0.05 inch) from the proximal end of the impeller portion.

[0017] In Example 20, in the percutaneous circulatory support device of Example 16, the pre-formed curved portion is offset by a distance of 16.5 mm to 1.27 mm (0.65 inches to 0.05 inches) from the proximal end of the impeller portion.

[0018] In Example 21, in the percutaneous circulatory support device of Example 16, the pre-formed curved portion is offset by a distance of 14.0 mm to 3.81 mm (0.55 inches to 0.15 inches) from the proximal end of the impeller portion.

[0019] In Example 22, in the percutaneous circulatory support device of Example 16, the pre-formed curved portion has an arc length in the range of 47.8 mm to 16.0 mm (1.88 inches to 0.63 inches).

[0020] In Example 23, in the percutaneous circulatory support device of Example 16, the pre-formed curved portion has an arc length in the range of 43.2 mm to 27.9 mm (1.70 inches to 1.10 inches).

[0021] In Example 24, in the percutaneous circulatory support device of Example 16, the pre-formed curved portion has an arc length in the range of 40.6 mm to 30.5 mm (1.60 inches to 1.20 inches).

[0022] In Example 25, in the percutaneous circulatory support device of Example 16, the pre-formed curved portion is a pre-formed catheter curved portion, and the cannula includes a pre-formed cannula curved portion.

[0023] In Example 26, in the percutaneous circulatory assist device of Example 25, the preformed curved portion of the catheter and the preformed curved portion of the cannula are arranged in a common plane. In Example 27, the percutaneous circulatory assist device includes an impeller portion having a distal end portion, a proximal end portion, and an impeller rotatable to allow blood to flow through the percutaneous circulatory assist device. A cannula is coupled to the distal end portion, and a catheter is coupled to the proximal end portion. The catheter includes the preformed curved portion, which is a preformed curved portion having an arc length in a range of 47.8 mm to 16.0 mm (1.88 inches to 0.63 inches) and is offset by a distance in a range of 25.4 mm to 1.27 mm (1.00 inch to 0.05 inch) from the proximal end portion.

[0024] In Example 28, in the percutaneous circulatory assist device of Example 27, the preformed curved portion has a radius in a range of 50.8 mm to 6.35 mm (2.00 inches to 0.25 inch). In Example 29, in the percutaneous circulatory assist device of Example 27, the preformed curved portion is a preformed curved portion of a catheter, and the cannula includes a preformed curved portion of the cannula.

[0025] Example 30 is the percutaneous circulatory assist device according to Example 29, wherein the preformed curved portion of the catheter and the preformed curved portion of the cannula are arranged in a common plane. In Example 31, a method for manufacturing a percutaneous circulatory assist device includes providing an impeller portion including a distal end portion, a proximal end portion, and a rotatable impeller, coupling a cannula to the distal end portion, and coupling a catheter to the proximal end portion, wherein the catheter includes a preformed curved portion having a radius in a range of 50.8 mm to 6.35 mm (2.00 inches to 0.25 inch).

[0026] In Example 32, which is the method of Example 31, the preformed curved portion has an arc length in a range of 47.8 mm to 16.0 mm (1.88 inches to 0.63 inches). In Example 33, which is the method of Example 31, the pre-formed curved portion is offset by a distance ranging from 25.4 mm to 1.27 mm (1.00 inch to 0.05 inch) from the proximal end of the impeller portion.

[0027] In Example 34, which is the method of Example 31, the pre-formed curved portion is a pre-formed catheter curved portion, and the cannula includes a pre-formed cannula curved portion. In Example 35, which is the method of Example 31, the pre-formed catheter curved portion and the pre-formed cannula curved portion are arranged in a common plane.

[0028] While a plurality of embodiments have been disclosed, still other embodiments of the present invention will become apparent to those skilled in the art from the following detailed description, which shows and describes exemplary embodiments of the present invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature rather than restrictive. [BRIEF DESCRIPTION OF THE DRAWINGS]

[0029] [Figure 1] FIG. 1 is a partial side view of an exemplary percutaneous circulatory support device (also interchangeably referred to herein as a "blood pump") arranged in the aorta and left ventricle of a patient, in accordance with an embodiment of the subject matter disclosed herein. [Figure 2] FIG. 2 is another partial side view of the percutaneous circulatory support device of FIG. 1. [Figure 3] FIG. 3 is a detailed side view of the percutaneous circulatory support device within line 3-3 of FIG. 2. [DESCRIPTION OF THE EMBODIMENTS]

[0030] While the invention is susceptible to various modifications and alternative forms, specific embodiments have been shown by way of example in the drawings and are described in detail below. However, there is no intention to limit the invention to the specific embodiments described. On the contrary, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

[0031] Detailed explanation Figure 1 shows a portion of an exemplary percutaneous mechanical circulatory assist device 100 (also synonymously referred to herein as the “blood pump”) according to embodiments of the subject matter disclosed herein, and its relative position in the human aorta 10 and heart 12, more specifically the left ventricle 14. The blood pump 100 is delivered percutaneously by passing through the aorta 10, as shown in Figure 1, to the heart 12, and positioned relative to the left ventricle 14 and the aortic valve 16. In some embodiments, the blood pump 100 may be delivered using a guidewire 101, as illustrated.

[0032] Continuing to refer to Figure 1, and further to Figure 2, the blood pump 100 typically includes a distal extension 102 (Figure 2), a cannula 104, an impeller section 106, and a proximal catheter 108. The cannula 104 is connected to the distal end 110 of the impeller section 106, and the catheter 108 is connected to the proximal end 112 of the impeller section 106, for example, via a tapered connector 114. The cannula 104 and catheter may have a flexible structure to facilitate delivery by the blood pump 100. The cannula 104 includes one or more blood inlets 116 (Figure 2) located at its distal end 118, and the housing 122 of the impeller section 106 has one or more blood outlets 120. The housing 122 is equipped with an impeller 124 (Figure 1), which rotates relative to the housing 122, causing blood to flow into the inlets 116 and out through the housing 122 to the outlets 120. During operation, as shown in Figure 1, the blood pump 100 is positioned within the heart 12 such that its inlet 116 (Figure 2) is located within the left ventricle 14 and its outlet 120 is located within the aorta 10. As a result, when the impeller 124 rotates relative to the housing 122, blood flows from the left ventricle 14 through the cannula 104 and the impeller section 106 into the aorta 10.

[0033] Continuing to refer to Figures 1 and 2, both the cannula 104 and the catheter 108 include pre-formed curves (as used herein, the term “pre-formed” and its variations mean that the features exist before entering the patient’s vascular system). More specifically, the cannula 104 includes a curved longitudinal axis that provides a first pre-formed curve 126 (also known as the pre-formed cannula curve 126), and the catheter 108 includes a curved longitudinal axis that provides a second pre-formed curve 128 (also known as the pre-formed catheter curve 128). Advantageously, the pre-formed curves 126, 128 facilitate the application of relatively small forces to the aortic valve 16. Similarly, the pre-formed catheter curve 128 reduces or eliminates the tendency for the catheter 108 to straighten within the aorta 10. As a result, the pre-formed curves 126, 128 improve the stability of the device, allowing the blood pump 100, including the proximal catheter 108 and cannula 104, to be properly positioned within the patient’s anatomical structure. In some embodiments, as shown in the figures, the pre-formed catheter curved portion 128 and the pre-formed cannula curved portion 126 are arranged in a common plane.

[0034] The pre-formed catheter curved portion 128 can have various dimensions. For example, referring to Figures 2 and 3, the pre-formed catheter curved portion 128 may have radii 130 in the range of 38.1 mm to 22.9 mm (1.50 inches to 0.90 inches), 35.6 mm to 25.4 mm (1.40 inches to 1.00 inches), or 33.0 mm to 27.9 mm (1.30 inches to 1.10 inches). The pre-formed catheter curved portion 128 may be offset from the proximal end 112 of the impeller portion 106 by a distance 132 in the range of 16.5 mm to 1.27 mm (0.65 inches to 0.05 inches), 14.0 mm to 3.81 mm (0.55 inches to 0.15 inches), or 11.4 mm to 6.35 mm (0.45 inches to 0.25 inches). The pre-formed catheter curved portion 128 may include arcs in the range of 80 to 53 degrees, 76 to 57 degrees, or 72 to 62 degrees (i.e., arc lengths 134 in the range of 43.2 mm to 27.9 mm (1.70 inches to 1.10 inches), 40.6 mm to 30.5 mm (1.60 inches to 1.20 inches), or 38.1 mm to 33.0 mm (1.50 inches to 1.30 inches).

[0035] As another example, a pre-formed catheter curved portion 128 may have a radius 130 in the range of 50.8 mm to 6.35 mm (2.00 inches to 0.25 inches). The pre-formed catheter curved portion 128 may be offset by a distance 132 in the range of 25.4 mm to 1.27 mm (1.00 inches to 0.05 inches) from the proximal end 112 of the impeller portion 106. The pre-formed catheter curved portion 128 may include a 90-degree to 30-degree arc (i.e., an arc length 134 in the range of 47.8 mm to 16.0 mm (1.88 inches to 0.63 inches)).

[0036] A method for manufacturing a blood pump according to embodiments of the subject disclosed herein is typically as follows. This method describes the characteristics of blood pump 100, but it is understood that any blood pump assumed herein can be used in a similar manner. First, an impeller 106, a cannula 104, and a catheter 108 are prepared. Next, the cannula 104 is joined to the distal end 110 of the impeller 106 (by welding, bonding, etc.), and the catheter 108 is joined to the proximal end 112 of the impeller 106. Then, for example, heated air is applied to the catheter 108, and the catheter 108 is bent on a mandrel (not shown) to form a curved portion 128 in the catheter 108. Alternatively, the curved portion 128 may be formed in the catheter 108 before joining the catheter 108 to the impeller 106.

[0037] Various modifications and additions can be made to the exemplary embodiments described without departing from the scope of the present invention. For example, while the embodiments described above refer to certain features, the scope of the invention also includes embodiments having different combinations of features, and embodiments that do not include all of the described features. Accordingly, the scope of the invention is intended to encompass all alternatives, modifications, and changes included in the claims, as well as all their equivalents.

Claims

1. A percutaneous circulatory support device, An impeller section comprising a proximal end, a distal end, one or more outlets, and an impeller rotatable to allow blood to flow through the percutaneous circulatory support device, A cannula coupled to the distal end of the impeller portion, the cannula comprising one or more inlets in the distal portion of the cannula and a pre-formed cannula curved portion, and A catheter connected to the proximal end of the impeller portion The catheter includes a pre-formed catheter curved portion having a radius in the range of 50.8 mm to 6.35 mm (2.00 inches to 0.25 inches), The pre-formed catheter curved portion and the pre-formed cannula curved portion are arranged in a common plane. A percutaneous circulatory support device in which, when the percutaneous circulatory support device is positioned such that one or more inlets are in the left ventricle and one or more outlets are in the aorta, the pre-formed catheter curved portion is positioned along the aortic arch of the aorta proximal to the impeller portion, and the cannula is positioned across the aortic valve distal to the impeller portion.

2. The percutaneous circulatory support device according to claim 1, wherein the radius of the pre-formed catheter curved portion is in the range of 38.1 mm to 22.9 mm (1.50 inches to 0.90 inches).

3. The percutaneous circulatory support device according to claim 1, wherein the radius of the pre-formed catheter curved portion is in the range of 35.6 mm to 25.4 mm (1.40 inches to 1.00 inch).

4. The percutaneous circulatory support device according to any one of claims 1 to 3, wherein the pre-formed catheter curved portion is offset by a distance of 25.4 mm to 1.27 mm (1.00 inch to 0.05 inch) from the proximal end of the impeller portion.

5. The percutaneous circulatory support device according to any one of claims 1 to 3, wherein the pre-formed catheter curved portion is offset by a distance of 16.5 mm to 1.27 mm (0.65 inches to 0.05 inches) from the proximal end of the impeller portion.

6. The percutaneous circulatory support device according to any one of claims 1 to 3, wherein the pre-formed catheter curved portion is offset by a distance of 14.0 mm to 3.81 mm (0.55 inches to 0.15 inches) from the proximal end of the impeller portion.

7. The percutaneous circulatory support device according to any one of claims 1 to 3, wherein the pre-formed catheter curved portion has an arc length in the range of 47.8 mm to 16.0 mm (1.88 inches to 0.63 inches).

8. The percutaneous circulatory support device according to any one of claims 1 to 3, wherein the pre-formed catheter curved portion has an arc length in the range of 43.2 mm to 27.9 mm (1.70 inches to 1.10 inches).

9. The percutaneous circulatory support device according to any one of claims 1 to 3, wherein the pre-formed catheter curved portion has an arc length in the range of 40.6 mm to 30.5 mm (1.60 inches to 1.20 inches).

10. A percutaneous circulatory support device, An impeller section comprising a proximal end, a distal end, one or more outlets, and an impeller rotatable to allow blood to flow through the percutaneous circulatory support device, A cannula coupled to the distal end of the impeller portion, the cannula comprising one or more inlets in the distal portion of the cannula and a pre-formed cannula curved portion, and A catheter connected to the proximal end of the impeller portion The catheter includes a pre-formed catheter curved portion having an arc length in the range of 47.8 mm to 16.0 mm (1.88 inches to 0.63 inches) and offset from the proximal end by a distance in the range of 25.4 mm to 1.27 mm (1.00 inches to 0.05 inches), The pre-formed catheter curved portion and the pre-formed cannula curved portion are arranged in a common plane. A percutaneous circulatory support device in which, when the percutaneous circulatory support device is positioned such that one or more inlets are in the left ventricle and one or more outlets are in the aorta, the pre-formed catheter curved portion is positioned along the aortic arch of the aorta proximal to the impeller portion, and the cannula is positioned across the aortic valve distal to the impeller portion.

11. The percutaneous circulatory support device according to claim 10, wherein the pre-formed catheter curved portion has a radius in the range of 50.8 mm to 6.35 mm (2.00 inches to 0.25 inches).

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