Percutaneous circulatory assist device including a proximal guidewire lumen - Patent Application 20070122997

Abstract

The percutaneous circulatory assist device includes an impeller housing configured to receive a guidewire during delivery of the percutaneous circulatory assist device to a patient. A catheter is coupled to a proximal end portion of the impeller housing, the catheter including a lumen configured to receive the guidewire during delivery of the percutaneous circulatory assist device to the patient. The impeller is rotatable within the impeller housing after delivery of the percutaneous circulatory assist device to the patient to flow blood through the percutaneous circulatory assist device.

Description

[Technical Field]

[0001] The present disclosure relates to percutaneous circulatory assist devices. Specifically, the present disclosure relates to percutaneous circulatory assist devices delivered using a guidewire. This application claims the benefit of U.S. Provisional Patent Application No. 63 / 455,930, filed March 30, 2023, which is incorporated herein by reference. [Background technology]

[0002] Percutaneous circulatory assist devices (also interchangeably referred to as "blood pumps") can provide temporary support for up to approximately several weeks in patients with reduced cardiac function or output. FIG. 1 illustrates a prior art blood pump 100. The blood pump 100 is delivered percutaneously by advancing it along a guidewire 102 placed inside the patient's body, specifically through the aorta 10, the aortic valve 12, and into the left ventricle 14 of the heart 16. The blood pump 100 accepts the guidewire 102 such that the guidewire 102 passes through a cannula 104 of the pump 100 and through an impeller housing 106 of the pump 100 and exits through an outlet 108 of the impeller housing 106. As illustrated, when the pump 100 is positioned distal to and through the aortic arch 18, the guidewire 102 extends from the outlet 108 at a relatively steep angle. This can result in the guidewire 102 being subjected to relatively high contact forces at the outlet 108 of the impeller housing 106, potentially damaging the outer coating of the guidewire 102. Therefore, an improved device would be beneficial. Summary of the Invention

[0003] In Example 1, a percutaneous circulatory assist device includes an impeller housing configured to receive a guidewire during delivery of the percutaneous circulatory assist device to a patient. A catheter is coupled to a proximal end portion of the impeller housing, the catheter including a lumen configured to receive the guidewire during delivery of the percutaneous circulatory assist device to the patient. An impeller is rotatable within the impeller housing after delivery of the percutaneous circulatory assist device to the patient to force blood through the percutaneous circulatory assist device.

[0004] In Example 2, the impeller housing of the percutaneous circulatory assist device of Example 1 includes an outlet, the impeller is rotatable within the impeller housing to force blood through the percutaneous circulatory assist device through the outlet, and the outlet allows the guidewire to extend through the outlet during delivery of the percutaneous circulatory assist device to the patient. In Example 3, the lumen in the percutaneous circulatory assist device of any one of Examples 1 to 2 is an auxiliary lumen, the catheter further includes a main lumen, and the percutaneous circulatory assist device further includes a cable disposed within the main lumen, the cable being operably connected to the impeller.

[0005] In Example 4, the catheter in the percutaneous circulatory assist device of Example 3 includes a first wall and a second wall coupled to the first wall, the first wall defining the main lumen, and the second wall defining the auxiliary lumen.

[0006] In Example 5, the percutaneous circulatory assist device of Example 4 further comprises a connector coupling the auxiliary lumen to the main lumen. In Example 6, the catheter in the percutaneous circulatory assist device of Example 3 includes an outer circumferential surface, and the main lumen and the auxiliary lumen are disposed radially inward from the outer circumferential surface.

[0007] In Example 7, the impeller housing in the percutaneous circulatory assist device of any one of Examples 1 to 6 further includes a distal end portion opposite the proximal end portion, and the percutaneous circulatory assist device further includes a cannula coupled to the distal end portion of the impeller housing, the cannula configured to receive the guide wire during delivery of the percutaneous circulatory assist device to the patient.

[0008] In Example 8, the lumen of the percutaneous circulatory assist device of any one of Examples 1 to 6 has a length ranging from 1 inch to 12 inches. In Example 9, a percutaneous circulatory assist device includes a catheter including a lumen. A housing is coupled to the catheter, the housing including an inlet and an outlet, the housing configured to receive a guidewire during delivery of the percutaneous circulatory assist device to a patient, the guidewire exiting the outlet and extending through the lumen of the catheter. An impeller is disposed distal to the catheter and coupled to the housing. The impeller is rotatable to direct blood into the inlet, through the housing, and out the outlet after delivery of the percutaneous circulatory assist device to the patient.

[0009] In Example 10, the lumen in the percutaneous circulatory assist device of Example 9 is an auxiliary lumen, the catheter further includes a main lumen, and the percutaneous circulatory assist device further includes a cable disposed within the main lumen, the cable being operably coupled to the impeller.

[0010] In Example 11, the catheter in the percutaneous circulatory assist device of Example 10 includes a first wall and a second wall coupled to the first wall, the first wall defining the main lumen, and the second wall defining the auxiliary lumen.

[0011] In Example 12, the percutaneous circulatory assist device of Example 11 further comprises a connector connecting the auxiliary lumen to the main lumen. In Example 13, the catheter in the percutaneous circulatory assist device of Example 10 includes an outer circumferential surface, and the main lumen and the auxiliary lumen are disposed radially inward from the outer circumferential surface.

[0012] In Example 14, the percutaneous circulatory assist device of any one of Examples 9 to 13 further includes a cannula positioned distal to the impeller, and the percutaneous circulatory assist device is configured to receive the guidewire during delivery to the patient such that the guidewire exits the outlet through the cannula and extends through the lumen of the catheter.

[0013] In Example 15, the lumen of the percutaneous circulatory assist device of any one of Examples 9 to 14 has a length ranging from 1 inch to 12 inches. In Example 16, a percutaneous circulatory assist device includes an impeller housing having a proximal end portion configured to receive a guidewire during delivery of the percutaneous circulatory assist device to a patient, an impeller rotatable within the impeller housing to force blood through the percutaneous circulatory assist device, and a catheter coupled to the proximal end portion of the impeller housing, the catheter configured to receive the guidewire during delivery of the percutaneous circulatory assist device to the patient.

[0014] In Example 17, the impeller housing of the percutaneous circulatory assist device of Example 16 includes an outlet, and the impeller is rotatable within the impeller housing to force blood through the percutaneous circulatory assist device through the outlet, and the outlet allows the guidewire to extend through the outlet during delivery of the percutaneous circulatory assist device to the patient.

[0015] In Example 18, the lumen in the percutaneous circulatory assist device of Example 16 is an auxiliary lumen, the catheter further includes a main lumen, and the percutaneous circulatory assist device further includes a cable disposed within the main lumen, the cable being operably connected to the impeller.

[0016] In Example 19, the catheter in the percutaneous circulatory assist device of Example 18 includes a first wall and a second wall coupled to the first wall, the first wall defining the main lumen, and the second wall defining the auxiliary lumen.

[0017] In Example 20, the catheter in the percutaneous circulatory assist device of Example 18 includes an outer circumferential surface, and the main lumen and the auxiliary lumen are disposed radially inward from the outer circumferential surface.

[0018] In Example 21, the impeller housing in the percutaneous circulatory assist device of Example 16 further includes a distal end portion opposite the proximal end portion, and the percutaneous circulatory assist device further includes a cannula coupled to the distal end portion of the impeller housing, the cannula being configured to receive the guide wire.

[0019] In Example 22, the lumen in the percutaneous circulatory assist device of Example 16 has a length ranging from 1 inch to 12 inches. In Example 23, the percutaneous circulatory assist device includes an inlet, an outlet, and a rotatable impeller to direct blood through the percutaneous circulatory assist device and out the outlet. A catheter is disposed proximal to the impeller and includes a lumen. The percutaneous circulatory assist device is configured to receive a guidewire during delivery to the patient, such that the guidewire extends from the outlet through the lumen of the catheter.

[0020] In Example 24, the lumen in the percutaneous circulatory assist device of Example 23 is an auxiliary lumen, the catheter further includes a main lumen, and the percutaneous circulatory assist device further includes a cable disposed within the main lumen, the cable being operably connected to the impeller.

[0021] In Example 25, the catheter in the percutaneous circulatory assist device of Example 24 includes a first wall and a second wall coupled to the first wall, the first wall defining the main lumen, and the second wall defining the auxiliary lumen.

[0022] In Example 26, the catheter in the percutaneous circulatory assist device of Example 24 includes an outer circumferential surface, and the main lumen and the auxiliary lumen are disposed radially inward from the outer circumferential surface.

[0023] In Example 27, the percutaneous circulatory assist device of Example 23 further includes a cannula positioned distal to the impeller, wherein the percutaneous circulatory assist device is configured to receive the guidewire during delivery to the patient such that the guidewire passes through the cannula, exits the outlet, and extends through the lumen of the catheter.

[0024] In Example 28, the lumen in the percutaneous circulatory assist device of Example 23 has a length ranging from 1 inch to 12 inches. In Example 29, a method of delivering a percutaneous circulatory assist device to a patient includes placing a guidewire within the patient, inserting the guidewire through a housing of the percutaneous circulatory assist device and into a lumen of a catheter of the percutaneous circulatory assist device, and advancing the percutaneous circulatory assist device over the guidewire.

[0025] In Example 30, inserting the guidewire in the method of Example 29 includes inserting the guidewire through the housing and out of an exit port of the housing.

[0026] In Example 31, the inserting the guidewire in the method of Example 29 includes inserting the guidewire through a cannula of the percutaneous circulatory assist device. In Example 32, the lumen of the catheter in the method of Example 29 is an auxiliary lumen, the catheter further includes a main lumen, and the percutaneous circulatory assist device further includes a cable disposed within the main lumen, the cable being operably coupled to the impeller of the percutaneous circulatory assist device.

[0027] In Example 33, the catheter in the method of Example 32 includes a first wall and a second wall coupled to the first wall, the first wall defining a main lumen, and the second wall defining an auxiliary lumen.

[0028] In Example 34, the catheter of the method of Example 32 includes an outer circumferential surface, and the main lumen and the auxiliary lumen are disposed radially inward from the outer circumferential surface. In Example 35, the lumen in the method of Example 29 has a length ranging from 1 inch to 12 inches.

[0029] 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 explanation of the drawings]

[0030] [Figure 1] FIG. 1 is a partial side view of an exemplary prior art percutaneous circulatory assist device positioned within the aorta and left ventricle of a patient. [Figure 2] FIG. 2 is a partial side view of an exemplary percutaneous circulatory assist device positioned within the aorta and left ventricle of a patient, according to an embodiment of the subject matter disclosed herein. [Figure 3]3 is another partial side view of the percutaneous circulatory assist device of FIG. 2. FIG. [Figure 4] 4 is a partial cross-sectional side view of a proximal portion of the percutaneous circulatory assist device of FIG. 2. FIG. [Figure 5] FIG. 5 is a partial side cross-sectional view of a proximal portion of another exemplary percutaneous circulatory assist device, according to an embodiment of the subject matter disclosed herein. [Figure 6] FIG. 6 is a schematic illustration of an exemplary method of delivering a percutaneous circulatory assist device within a patient, according to an embodiment of the subject matter disclosed herein. DETAILED DESCRIPTION OF THE INVENTION

[0031] 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 specific embodiments described. Rather, the invention is intended to cover all modifications, equivalents, and alternatives falling within the scope of the invention as defined by the appended claims.

[0032] FIG. 2 illustrates a portion of an exemplary percutaneous mechanical circulatory assist device 200 (hereinafter interchangeably referred to as a "blood pump") according to an embodiment of the subject matter disclosed herein, and its relative position to a human aorta 10 and heart 16, specifically the left ventricle 14. The blood pump 200 is delivered percutaneously by passing a guidewire 202 through the aorta 10 and positioned within the heart 16 relative to the left ventricle 14 and aortic valve 12, as shown in FIG. 2. In contrast to the blood pump 100, the blood pump 200 prevents the guidewire 202 from extending from the pump 200 at a relatively steep angle, thereby preventing relatively high contact forces and potential damage to the guidewire 202. These aspects are described in further detail below.

[0033] With continuing reference to FIG. 2 and with further reference to FIG. 3, blood pump 200 generally includes a distal extension portion 204 (FIG. 3), a cannula 206, an impeller portion 208, and a proximal catheter 210. Cannula 206 is coupled to a distal end portion 212 of impeller portion 208, and catheter 210 is coupled to a proximal end portion 214 of impeller portion 208, for example, via a tapered connector 216. Cannula 206 and catheter 210 may have flexible structures to facilitate delivery of blood pump 200. Cannula 206 includes one or more blood inlets 218 (FIG. 3) located on a distal portion 220 thereof, and one or more blood outlets 222 are located on an impeller housing 224 of impeller portion 208. Housing 224 supports impeller 226 (FIG. 2), which rotates relative to housing 224, forcing blood into inlet 218, through housing 224, and out outlet 222. As shown in FIG. 2, during delivery, blood pump 200 is positioned within heart 16 so that inlet 218 (FIG. 3) is located within left ventricle 14 and outlet 222 is located within aorta 10. Rotation of impeller 226 relative to housing 224 thus causes blood to flow from left ventricle 14, through cannula 206, impeller portion 208, and into aorta 10.

[0034] 2 and 3, cannula 206 includes a preformed curve (as used herein, the term "preformed" and variations thereof mean that a feature is present prior to entering the patient's vasculature). Specifically, cannula 206 includes a bent longitudinal axis that provides preformed curve 228. Although not specifically shown, in some embodiments, catheter 210 also includes one or more preformed curves.

[0035] With continued reference to FIGS. 2 and 3 , and with further reference to FIG. 4 , during delivery, pump 200 receives and is advanceable over guidewire 202. Specifically, distal end portion 212 of guidewire 202 is disposed distal to distal extension 204. Guidewire 202 passes into and through distal extension 204, cannula 206, impeller housing 224, and exits through outlet 222. In some embodiments, a guidewire insertion aid (not shown) may be incorporated into pump 200 to facilitate passage of guidewire 202 through pump 200, as described below. In contrast to blood pump 100, guidewire 202 also passes into and through proximal catheter 210. Specifically, guidewire 202 passes into and through an auxiliary lumen, i.e., guidewire lumen 230, of catheter 210. By receiving guidewire 202 in this manner, blood pump 200 prevents guidewire 202 from extending from outlet 222 at a relatively steep angle, thereby preventing relatively high contact forces (i.e., frictional contact) from occurring between housing 224 (specifically, at outlet 222) and guidewire 202, thereby reducing potential damage to guidewire 202 due to such forces. Also, by receiving guidewire 202 in this manner, pump 200 prevents guidewire 202 from wrapping around a distal portion of pump 200.

[0036] The auxiliary lumen 230 has a length sufficient to maintain the guidewire 202 in proximity to the blood pump 200, and particularly the catheter 210, within the patient's aortic arch. The auxiliary lumen 230 may terminate in the descending aorta. For example, the auxiliary lumen 230 may have a length ranging from 1 inch (=2.54 cm) to 12 inches. As another example, the auxiliary lumen 230 may have a length substantially equal to the length of the catheter 210. As yet another example, the auxiliary lumen 230 may be offset from the housing 224 by approximately 0.8 inches and have a length of approximately 0.25 inches. In some embodiments, the auxiliary lumen 230 has a diameter sufficient to accommodate both the guidewire 202 and a guidewire insertion aid (not shown). For example, the guidewire insertion aid may be any of the guidewire insertion aids discussed in U.S. Patent Application No. 63 / 384,333, filed November 18, 2022, the disclosure of which is incorporated herein by reference. For example, auxiliary lumen 230 may have a diameter ranging from a minimum diameter sufficient to accommodate a guidewire and a maximum diameter sufficient to accommodate a guidewire insertion aid. Specifically, auxiliary lumen 230 may have a diameter ranging from 0.018 inches to 0.042 inches.

[0037] Referring to FIG. 4 , catheter 210 illustratively includes a tubular first wall 232 and a tubular second wall 234. First wall 232 defines a main lumen 236, and second wall 234 defines an auxiliary lumen 230. Main lumen 236 supports, for example, a cable 238 operably coupled to impeller 226 (shown elsewhere). Specifically, cable 238 provides power to a motor (not shown) that indirectly or directly drives impeller 226. Note that other components, such as a cable coupled to a sensor (e.g., a pressure sensor), may also pass through main lumen 236. First wall 232 and second wall 234 may be coupled in various ways, such as by bonding, welding, polymer reflow, and / or one or more heat-shrink connectors 240. As described herein, auxiliary lumen 230 supports guidewire 202 at least during delivery of blood pump 200 into aorta 10 and heart 16.

[0038] Blood pumps according to embodiments of the subject matter disclosed herein may include catheters with different structures. For example, FIG. 5 shows a proximal portion of another exemplary percutaneous circulatory assist device 300 according to embodiments of the subject matter disclosed herein. The blood pump 300 is generally similar to the blood pump 200 described above, except that the catheter 302 includes a different structure. Specifically, the catheter 302 includes a vessel wall 304, a main lumen 306 disposed radially inward from the vessel wall 304, and an auxiliary lumen 308 disposed within the vessel wall 304. Stated differently, the catheter 302 includes an outer circumferential surface 310, and the main lumen 306 and the auxiliary lumen 308 are disposed radially inward from the outer circumferential surface 310. As described above with respect to the blood pump 200, the main lumen 306 may support one or more cables operably coupled to a motor and / or one or more sensors. The auxiliary lumen 308 is configured to support a guidewire.

[0039] FIG. 6 illustrates an exemplary method 400 for delivering a percutaneous circulatory assist device within a patient's body according to embodiments of the subject matter disclosed herein. The following description of method 400 refers only to blood pump 200 and its features shown in FIGS. 2-4, although any blood pump contemplated herein may be delivered in a similar manner. At block 402, the method begins by placing a guidewire 202 within the patient. Specifically, the distal end portion 212 of guidewire 202 is percutaneously inserted into the patient and advanced through the aorta 10 and aortic valve 12 into the left ventricle 14. The proximal end portion (not shown) of guidewire 202 remains outside the patient. At block 404, the method continues by inserting the proximal end portion of guidewire 202 through distal extension 204, cannula 206, and impeller housing 224, out exit outlet 222, and through guidewire lumen 230 of catheter 210. In block 406, the blood pump 200 is advanced distally along the guidewire 202 until the blood pump 200 is properly positioned within the patient. Specifically, the blood pump 200 is threaded into the aorta 10, past the aortic valve 12, and positioned within the left ventricle 14, as shown in FIG.

[0040] Various modifications and additions can be made to the described exemplary embodiments without departing from the scope of the present invention. For example, while the above-described embodiments refer to particular features, the scope of the present 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 present invention is intended to encompass all such alternatives, modifications, and variations that fall within the scope of the claims, together with all equivalents thereof.

Claims

1. 1. A percutaneous circulatory assist device, comprising: an impeller housing configured to receive a guidewire during delivery of the percutaneous circulatory assist device to a patient; a catheter coupled to a proximal end portion of the impeller housing, the catheter including a lumen configured to receive the guidewire during delivery of the percutaneous circulatory assist device to the patient; an impeller rotatable within the impeller housing after delivery of the percutaneous circulatory assist device to the patient to drive blood through the percutaneous circulatory assist device; A percutaneous circulatory assist device comprising:

2. 2. The percutaneous circulatory assist device of claim 1, wherein the impeller housing includes an outlet, the impeller is rotatable within the impeller housing to force blood through the percutaneous circulatory assist device and out the outlet, and the outlet allows the guidewire to extend through the outlet during delivery of the percutaneous circulatory assist device to the patient.

3. 3. The percutaneous circulatory assist device of claim 1, wherein the lumen is an auxiliary lumen, the catheter further comprises a main lumen, and the percutaneous circulatory assist device further comprises a cable disposed within the main lumen, the cable being operably coupled to the impeller.

4. 4. The percutaneous circulatory assist device of claim 3, wherein the catheter includes a first wall and a second wall coupled to the first wall, the first wall defining the main lumen and the second wall defining the auxiliary lumen.

5. The percutaneous circulatory assist device of claim 4 further comprising a connector coupling the auxiliary lumen to the main lumen.

6. The percutaneous circulatory assist device of claim 3 , wherein the catheter includes an outer circumferential surface, and the main lumen and the auxiliary lumen are disposed radially inward from the outer circumferential surface.

7. 7. The percutaneous circulatory assist device of claim 1, wherein the impeller housing further includes a distal end portion opposite the proximal end portion, and wherein the percutaneous circulatory assist device further comprises a cannula coupled to the distal end portion of the impeller housing, the cannula configured to receive the guidewire during delivery of the percutaneous circulatory assist device to the patient.

8. The percutaneous circulatory assist device of any one of claims 1 to 6, wherein the lumen has a length in the range of 1 inch to 12 inches.

9. 1. A percutaneous circulatory assist device, comprising: a catheter including a lumen; a housing coupled to the catheter, the housing including an inlet and an outlet, the housing configured to receive the guidewire during delivery of the percutaneous circulatory assist device to a patient, the guidewire exiting the outlet and extending through the lumen of the catheter; an impeller disposed distal to the catheter and coupled to the housing, the impeller rotatable to direct blood into the inlet, through the housing, and out the outlet following delivery of the percutaneous circulatory assist device to the patient; A percutaneous circulatory assist device comprising:

10. 10. The percutaneous circulatory assist device of claim 9, wherein the lumen is an auxiliary lumen, the catheter further comprises a main lumen, and the percutaneous circulatory assist device further comprises a cable disposed within the main lumen, the cable being operably coupled to the impeller.

11. 11. The percutaneous circulatory assist device of claim 10, wherein the catheter includes a first wall and a second wall coupled to the first wall, the first wall defining the main lumen and the second wall defining the auxiliary lumen.

12. The percutaneous circulatory assist device of claim 11, further comprising a connector coupling the auxiliary lumen to the main lumen.

13. The percutaneous circulatory assist device of claim 10 , wherein the catheter includes an outer circumferential surface, and the main lumen and the auxiliary lumen are disposed radially inward from the outer circumferential surface.

14. 14. The percutaneous circulatory assist device of claim 9, further comprising a cannula positioned distal to the impeller, the percutaneous circulatory assist device configured to receive the guidewire during delivery to the patient such that the guidewire extends through the cannula, out the outlet, and through the lumen of the catheter.

15. The percutaneous circulatory assist device of any one of claims 9 to 14, wherein the lumen has a length in the range of 1 inch to 12 inches.

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