Percutaneous circulatory support device including a curved proximal catheter - Patents.com

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 particularly, the present disclosure relates to a percutaneous circulatory assist device that includes a curved proximal catheter. [Background technology]

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

[0003] In Example 1, a percutaneous circulatory assist device includes an impeller portion having a proximal end and an impeller rotatable to force blood through the percutaneous circulatory assist device, a catheter coupled to the proximal end, the catheter including a preformed curve having a radius in the range of 2.00 inches to 0.25 inches.

[0004] In Example 2, in the percutaneous circulatory assist device of Example 1, the radius of the preformed 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 of Example 1, the radius of the preformed curve ranges from 35.6 mm to 25.4 mm (1.40 inches to 1.00 inches).

[0005] In Example 4, in the percutaneous circulatory assist device of any of Examples 1 to 3, the preformed curved portion is offset from the proximal end of the impeller portion by a distance in the range of 25.4 mm to 1.27 mm (1.00 inches to 0.05 inches).

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

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

[0008] In Example 7, in the percutaneous circulatory assist device of any of Examples 1 to 6, the preformed 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 the percutaneous circulatory assist device of any of Examples 1 to 6, the preformed 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 the percutaneous circulatory assist device of any of Examples 1 to 6, the preformed 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 the percutaneous circulatory assist device of any of Examples 1 to 9, the impeller portion further includes a distal end, further includes a cannula coupled to the distal end, the preformed curved portion is a preformed catheter curved portion, and the cannula includes a preformed cannula curved portion.

[0012] In Example 11, the percutaneous circulatory assist device of Example 10, wherein the preformed catheter curve and the preformed cannula curve are disposed in a common plane. In Example 12, a percutaneous circulatory assist device includes a proximal end, an impeller portion including an impeller rotatable to force blood through the percutaneous circulatory assist device, and a catheter coupled to the proximal end, the catheter including a preformed curve 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, the percutaneous circulatory assist device of Example 12, wherein the preformed 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 the percutaneous circulatory assist device of any of Examples 12 to 13, the impeller portion further includes a distal end portion, and further includes a cannula coupled to the distal end portion, the preformed curved portion is a preformed catheter curved portion, and the cannula includes a preformed cannula curved portion.

[0014] In Example 15, the percutaneous circulatory assist device of Example 14, wherein the preformed catheter curve and the preformed cannula curve are disposed in a common plane. In Example 16, a percutaneous circulatory assist device includes an impeller portion having a distal end, a proximal end, and an impeller rotatable to force blood through the percutaneous circulatory assist device. A cannula is coupled to the distal end, and a catheter is coupled to the proximal end. The catheter has a preformed curve having a radius in the range of 2.00 inches to 0.25 inches.

[0015] In Example 17, the percutaneous circulatory assist device of Example 16 has a radius of the preformed curve in the range of 38.1 mm to 22.9 mm (1.50 inches to 0.90 inches). In Example 18, the percutaneous circulatory assist device of Example 16, the radius of the preformed curve ranges from 35.6 mm to 25.4 mm (1.40 inches to 1.00 inches).

[0016] In Example 19, the percutaneous circulatory assist device of Example 16, the preformed curved portion is offset from the proximal end of the impeller portion by a distance ranging from 1.00 inches to 0.05 inches.

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

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

[0019] In Example 22, the percutaneous circulatory assist device of Example 16, wherein the preformed 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, the percutaneous circulatory assist device of Example 16, wherein the preformed 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, the percutaneous circulatory assist device of Example 16, wherein the preformed 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, the percutaneous circulatory assist device of Example 16, wherein the preformed curve is a preformed catheter curve and the cannula includes a preformed cannula curve.

[0023] In Example 26, the percutaneous circulatory assist device of Example 25, wherein the preformed catheter curve and the preformed cannula curve are disposed in a common plane. In Example 27, a percutaneous circulatory assist device includes a distal end, a proximal end, and an impeller portion having a rotatable impeller to force blood through the percutaneous circulatory assist device. A cannula is coupled to the distal end and a catheter is coupled to the proximal end. The catheter includes a preformed curve having an arc length in the range of 1.88 inches to 0.63 inches and offset from the proximal end by a distance in the range of 1.00 inches to 0.05 inches.

[0024] In Example 28, the percutaneous circulatory assist device of Example 27, the preformed 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 29, the percutaneous circulatory assist device of Example 27, wherein the preformed curve is a preformed catheter curve and the cannula includes a preformed cannula curve.

[0025] Example 30 is the percutaneous circulatory assist device of example 29, wherein the preformed catheter curve and the preformed cannula curve are disposed in a common plane. In Example 31, a method of manufacturing a percutaneous circulatory assist device includes providing an impeller portion including a distal end, a proximal end, and a rotatable impeller, coupling a cannula to the distal end, and coupling a catheter to the proximal end, the catheter including a preformed curve having a radius in the range of 2.00 inches to 0.25 inches.

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

[0027] In Example 34, the method of Example 31, wherein the preformed curve is a preformed catheter curve and the cannula includes a preformed cannula curve. In Example 35, the method of Example 31, wherein the preformed catheter curve and the preformed cannula curve are disposed in a common plane.

[0028] While multiple embodiments are 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 illustrative embodiments of the invention. Accordingly, the drawings and detailed description are to be regarded as illustrative in nature and not restrictive. [Brief description of the drawings]

[0029] [Figure 1] FIG. 1 is a partial side view of an exemplary percutaneous circulatory assist device (also referred to interchangeably herein as a "blood pump") positioned in a patient's aorta and left ventricle in accordance with an embodiment of the subject matter disclosed herein. [Diagram 2] 2 is another partial side view of the percutaneous circulatory assist device of FIG. 1. [Diagram 3] FIG. 3 is a detailed side view of the percutaneous circulatory assist device within line 3-3 of FIG. 2. DETAILED DESCRIPTION OF THE PREFERRED 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. It is not intended, however, to limit the invention to the particular 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 Description 1 illustrates a portion of an exemplary percutaneous mechanical circulatory assist device 100 (also referred to interchangeably herein as a "blood pump") in accordance with an embodiment of the subject matter disclosed herein and its relative location in a human aorta 10 and heart 12, and more specifically, in the left ventricle 14. The blood pump 100 is delivered percutaneously by passing through the aorta 10 and positioned in the heart 12 relative to the left ventricle 14 and aortic valve 16, as shown in FIG. 1. In some embodiments, the blood pump 100 may be delivered using a guidewire 101, as shown.

[0032] With continued reference to FIG. 1 and further reference to FIG. 2, the blood pump 100 generally includes a distal extension 102 (FIG. 2), a cannula 104, an impeller portion 106, and a proximal catheter 108. The cannula 104 is coupled to a distal end 110 of the impeller portion 106, and the catheter 108 is coupled to a proximal end 112 of the impeller portion 106, for example, via a tapered connector 114. The cannula 104 and catheter may have a flexible structure to facilitate delivery of the blood pump 100. The cannula 104 includes one or more blood inlets 116 (FIG. 2) disposed at a distal portion 118 thereof, and one or more blood outlets 120 are disposed in a housing 122 of the impeller portion 106. The housing 122 carries an impeller 124 (FIG. 1) that rotates relative to the housing 122 to move blood into the inlet 116, through the housing 122, and out the outlet 120. 1, blood pump 100 is positioned within heart 12 such that inlet 116 (FIG. 2) is located within left ventricle 14 and outlet 120 is located within aorta 10. As a result, as impeller 124 rotates relative to housing 122, blood flows from left ventricle 14, through cannula 104 and impeller portion 106, and into aorta 10.

[0033] With continued reference to FIGS. 1 and 2, both the cannula 104 and the catheter 108 include preformed curves (as used herein, the term "preformed" and variations thereof means that the feature is present prior to entry into the patient's vasculature). More specifically, the cannula 104 includes a curved longitudinal axis that provides a first preformed curve 126 (also referred to as a preformed cannula curve 126), and the catheter 108 includes a curved longitudinal axis that provides a second preformed curve 128 (also referred to as a preformed catheter curve 128). Advantageously, the preformed curves 126, 128 facilitate application of relatively low forces to the aortic valve 16. Similarly, the preformed catheter curve 128 reduces or eliminates the tendency of the catheter 108 to straighten within the aorta 10. As a result, the preformed curves 126, 128 improve device stability and ensure that the blood pump 100, including the proximal catheter 108 and the cannula 104, is properly positioned within the patient's anatomy. In some embodiments, as shown, the preformed catheter curve 128 and the preformed cannula curve 126 are disposed in a common plane.

[0034] The preformed catheter curve 128 may have a variety of dimensions. For example, with reference to Figures 2 and 3, the preformed catheter curve 128 may have a radius 130 ranging from 1.50 inches to 0.90 inches, from 1.40 inches to 1.00 inches, or from 1.30 inches to 1.10 inches. The preformed catheter curve 128 may be offset from the proximal end 112 of the impeller portion 106 by a distance 132 ranging from 0.65 inches to 0.05 inches, from 0.55 inches to 0.15 inches, or from 0.45 inches to 0.25 inches. The preformed catheter curve 128 may include an arc ranging from 80 degrees to 53 degrees, from 76 degrees to 57 degrees, or from 72 degrees to 62 degrees (i.e., an arc length 134 ranging from 43.2 mm to 27.9 mm (1.70 inches to 1.10 inches), from 40.6 mm to 30.5 mm (1.60 inches to 1.20 inches), or from 38.1 mm to 33.0 mm (1.50 inches to 1.30 inches).

[0035] As another example, the preformed catheter curve 128 may have a radius 130 in the range of 2.00 inches to 0.25 inches. The preformed catheter curve 128 may be offset from the proximal end 112 of the impeller portion 106 by a distance 132 in the range of 1.00 inches to 0.05 inches. The preformed catheter curve 128 may include an arc of 90 degrees to 30 degrees (i.e., an arc length 134 in the range of 1.88 inches to 0.63 inches).

[0036] A method of manufacturing a blood pump in accordance with an embodiment of the subject matter disclosed herein is generally as follows. While the method is illustrative of features of blood pump 100, it is understood that any blood pump contemplated herein may be used in a similar manner. First, impeller portion 106, cannula 104, and catheter 108 are provided. Next, cannula 104 is bonded (by welding, gluing, etc.) to distal end 110 of impeller portion 106, and catheter 108 is bonded to proximal end 112 of impeller portion 106. Curve 128 is then formed in catheter 108, for example, by applying heated air to catheter 108 and bending catheter 108 over a mandrel (not shown). Alternatively, curve 128 may be formed in catheter 108 prior to bonding catheter 108 to impeller portion 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 above embodiments refer to certain features, the scope of the present invention also includes embodiments having different combinations of features or embodiments that do not include all of the described features. Accordingly, the scope of the present invention is intended to embrace all alternatives, modifications, and variations that fall within the scope of the claims, and all equivalents thereof.

Claims

1. A percutaneous circulatory assist device, comprising: an impeller portion including a proximal end and an impeller rotatable to drive blood through the percutaneous circulatory assist device; and A catheter coupled to the proximal end. wherein the catheter includes a preformed curve having a radius in the range of 2.00 inches to 0.25 inches.

2. 2. The percutaneous circulatory assist device of claim 1, wherein the radius of the preformed curve ranges from 1.50 inches to 0.90 inches.

3. 2. The percutaneous circulatory assist device of claim 1, wherein the radius of the preformed curve ranges from 1.40 inches to 1.00 inches.

4. 4. The percutaneous circulatory assist device of claim 1, wherein the preformed curve is offset from the proximal end of the impeller portion by a distance in the range of 1.00 inches to 0.05 inches.

5. 4. The percutaneous circulatory assist device of claim 1, wherein the preformed curve is offset from the proximal end of the impeller portion by a distance in the range of 16.5 mm to 1.27 mm (0.65 inches to 0.05 inches).

6. 4. The percutaneous circulatory assist device of claim 1, wherein the preformed curve is offset from the proximal end of the impeller portion by a distance in the range of 0.55 inches to 0.15 inches.

7. The percutaneous circulatory assist device of any one of claims 1 to 6, wherein the preformed curve 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 assist device of any one of claims 1 to 6, wherein the preformed curve 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 assist device of any one of claims 1 to 6, wherein the preformed curve has an arc length in the range of 40.6 mm to 30.5 mm (1.60 inches to 1.20 inches).

10. 10. The percutaneous circulatory assist device of claim 1, wherein the impeller portion further comprises a distal end, further comprises a cannula coupled to the distal end, the preformed curve being a preformed catheter curve, and the cannula comprises a preformed cannula curve.

11. The percutaneous circulatory assist device of claim 10 , wherein the preformed catheter curve and the preformed cannula curve are disposed in a common plane.

12. A percutaneous circulatory assist device, comprising: an impeller portion including a proximal end and an impeller rotatable to drive blood through the percutaneous circulatory assist device; and A catheter coupled to the proximal end. the catheter including a preformed curve having an arc length in the range of 47.8 mm to 16.0 mm (1.88 in. to 0.63 in.) and offset from the proximal end by a distance in the range of 25.4 mm to 1.27 mm (1.00 in. to 0.05 in.).

13. The percutaneous circulatory assist device of claim 12, wherein the preformed curve has a radius in the range of 2.00 inches to 0.25 inches.

14. 14. The percutaneous circulatory assist device of claim 12 or 13, wherein the impeller portion further comprises a distal end, and further comprises a cannula coupled to the distal end, the preformed curve being a preformed catheter curve, and the cannula comprising a preformed cannula curve.

15. 15. The percutaneous circulatory assist device of claim 14, wherein the preformed catheter curve and the preformed cannula curve are disposed in a common plane.

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