Device housing configuration for facilitating the translation of a guide wire without damage

The percutaneous circulatory assist device addresses guide wire damage by incorporating a supportive channel in the blood outlet opening, enhancing device performance and patient safety.

JP7693114B2Active Publication Date: 2025-06-16BOSTON SCIENTIFIC SCIMED INC
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Patent Information

Application Number
JP2024529308
Authority / Receiving Office
JP · JP
Patent Type
Patents
Current Assignee / Owner
Priority Date
2021-11-17
Filing Date
2022-11-17
Publication Date
2025-06-16
Estimated Expiration
2042-11-17

AI Technical Summary

Technical Problem

Percutaneous circulatory assist devices often damage guide wires due to contact with metallic device housings, leading to coating removal and performance issues.

Method used

The percutaneous circulatory assist device incorporates a channel within the blood outlet opening that supports the guide wire without causing damage, featuring a configuration that minimizes deformation and coating removal.

Benefits of technology

The device effectively reduces guide wire damage and deformation, ensuring smooth operation and reducing the risk of health complications associated with coating removal.

✦ Generated by Eureka AI based on patent content.

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Abstract

Various aspects of the present disclosure are directed to apparatus, systems, and methods including a percutaneous circulatory assist device for use with a guidewire, which may include a housing having a blood outlet opening that may include a channel configured to receive and support the guidewire.
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Description

Technical Field

[0001] The present disclosure relates to a percutaneous circulatory assist system. More specifically, the present disclosure relates to a percutaneous circulatory assist device that is delivered to a patient's heart using a guide wire.

Background Art

[0002] Percutaneous circulatory assist devices can provide temporary assistance for up to about several weeks in patients with reduced cardiac function or cardiac output. Such devices are typically delivered to a patient's heart using a guide wire, whereby the circulatory assist device is coupled to the guide wire and moved along the guide wire through the patient's vasculature until the device reaches an appropriate position within the heart. Generally, the circulatory assist device is coupled to the guide wire by feeding the proximal end of the guide wire, whose distal end has already been inserted into the patient's vasculature, through an opening of the device. The proximal end of the guide wire then passes through the device and exits the device through another opening. The device can then be moved along the length of the guide wire to insert the device into the patient's vasculature and ultimately into the patient's heart. When the guide wire passes through an opening in the device or when the device moves along the guide wire, the device is typically made of a metallic material while the guide wire is composed of a softer material or contains a coating, so the guide wire can be damaged. For example, the coating of the guide wire can be removed by contact between the guide wire and one of the surfaces of the opening. Removal of the coating material can cause health complications or adversely affect the performance of the guide wire and / or the device.

Summary of the Invention

[0003] In Example 1, a percutaneous circulatory assist device for use with a guide wire includes a housing having an internal lumen, an outer surface, a blood inlet, and a blood outlet including a blood outlet opening, the blood outlet opening including a channel extending from the internal lumen of the housing to the outer surface of the housing, the channel configured to receive and support the guide wire without causing damage.

[0004] In Example 2, in the percutaneous circulatory assist device described in Example 1, the device further includes an impeller disposed within the internal lumen, the impeller configured to rotate relative to the housing to cause blood to flow into the blood inlet and out of the blood outlet through the internal lumen of the housing, and a motor operably coupled to the impeller and configured to rotatably drive the impeller.

[0005] In Example 3, in the percutaneous circulatory assist device described in Example 1 or 2, the blood outlet opening is a first blood outlet opening, the blood outlet includes a second blood outlet opening, and the channel extends proximally beyond the second blood outlet opening.

[0006] In Example 4, in the percutaneous circulatory assist device described in any one of Examples 1 to 3, the channel includes an inclined first end. In Example 5, in the percutaneous circulatory assist device described in any one of Examples 1 to 3, the channel includes a rounded first end.

[0007] In Example 6, in the percutaneous circulatory assist device described in any one of Examples 1 to 5, the channel has a width greater than that of the guide wire. In Example 7, in the percutaneous circulatory assist device described in any one of Examples 1 to 6, the channel has a length of 0.0635 cm (0.025 inches) to 0.953 cm (0.375 inches).

[0008] In Example 8, in the percutaneous circulatory assist device described in any one of Examples 1 to 7, the channel includes a substantially flat surface for supporting a guide wire. In Example 9, in the percutaneous circulatory assist device described in any one of Examples 1 to 8, the channel is located in the proximal portion of the blood outlet opening.

[0009] In Example 10, in the percutaneous circulatory assist device described in any one of Examples 1 to 9, the housing includes a first housing portion on the proximal side of the channel and a second housing portion on the distal side of the channel, the first housing portion has a first diameter, the second housing portion has a second diameter, the first diameter is smaller than the second diameter, the first housing portion and the second housing portion, and a tapered housing portion extending between the first housing portion and the second housing portion, and the channel is located within the tapered housing portion.

[0010] In Example 11, in the percutaneous circulatory assist device described in Example 10, the channel includes a first side wall and a second side wall, and the first side wall and the second side wall are configured to form a flared opening adjacent to the first housing portion.

[0011] In Example 12, a method for using a percutaneous circulatory assist device includes inserting a distal end of a guide wire into a patient's vascular structure, inserting a proximal end of the guide wire into a housing of the device, the housing including an internal lumen, an impeller within the internal lumen, an outer surface, a blood outlet including a blood outlet opening, the blood outlet opening including a channel, the channel extending from the internal lumen of the housing to the outer surface of the housing and configured to receive and support the guide wire without causing damage, passing the proximal end of the guide wire through the internal lumen of the housing, passing the proximal end of the guide wire adjacent to the impeller, and passing the proximal end of the guide wire through the channel of the blood outlet opening such that the guide wire extends from the internal lumen of the housing to the outer surface of the housing.

[0012] In Example 13, in the method described in Example 12, the channel is located at the proximal portion of the blood outlet opening. In Example 14, in the method described in Example 13, the blood outlet opening is the first blood outlet opening, the housing includes a second blood outlet opening, and the channel extends proximally beyond the second blood outlet opening.

[0013] In Example 15, in the method described in any one of Examples 12 to 14, the method further includes the steps of moving the device along the guide wire and inserting the device into the patient's vasculature.

[0014] In Example 16, a percutaneous circulatory assist device for use with a guide wire includes a housing including an internal lumen, an outer surface, a blood inlet, and a blood outlet including a blood outlet opening, and an impeller disposed within the internal lumen and configured to rotate relative to the housing to cause blood to flow into the blood inlet and out of the blood outlet through the internal lumen of the housing. The device further includes a motor operably coupled to the impeller and configured to rotatably drive the impeller. The blood outlet opening includes a channel extending from the internal lumen of the housing to the outer surface of the housing, and the channel is configured to receive and support the guide wire without causing damage.

[0015] In Example 17, in the percutaneous circulatory assist device described in Example 16, the blood outlet opening is the first blood outlet opening, the blood outlet includes a second blood outlet opening, and the channel extends proximally beyond the second blood outlet opening.

[0016] In Example 18, in the percutaneous circulatory assist device described in Example 16, the channel includes an inclined first end. In Example 19, in the percutaneous circulatory assist device described in Example 16, the channel includes a rounded first end.

[0017] In Example 20, in the percutaneous circulatory assist device described in Example 16, the channel has a width larger than that of the guide wire. In Example 21, in the percutaneous circulatory assist device described in Example 16, the channel has a length of 0.0635 cm (0.025 inches) to 0.953 cm (0.375 inches).

[0018] In Example 22, in the percutaneous circulatory assist device described in Example 16, the channel includes a substantially flat surface for supporting the guide wire. In Example 23, in the percutaneous circulatory assist device described in Example 16, the channel is located at the proximal portion of the blood outlet opening.

[0019] In Example 24, in the percutaneous circulatory assist device described in Example 16, the housing includes a first housing portion on the proximal side of the channel and a second housing portion on the distal side of the channel, the first housing portion has a first diameter, the second housing portion has a second diameter, the first diameter is smaller than the second diameter, and the first housing portion and the second housing portion further include a tapered housing portion extending between the first housing portion and the second housing portion, and the channel is located within the tapered housing portion.

[0020] In Example 25, in the percutaneous circulatory assist device described in Example 24, the channel includes a first side wall and a second side wall, and the first side wall and the second side wall are configured to form a flared opening adjacent to the first housing portion.

[0021] In Example 26, a percutaneous circulatory assist device for use with a guide wire includes a housing having an internal lumen, an outer surface, a blood inlet, and a blood outlet including a first blood outlet opening and a second blood outlet opening, an impeller disposed within the internal lumen and configured to rotate relative to the housing to cause blood to flow into the blood inlet and out of the first and second blood outlet openings through the internal lumen of the housing, and a motor operably coupled to the impeller and configured to rotatably drive the impeller. The first blood outlet opening includes a channel configured to receive and support the guide wire without damage, and the channel extends proximally from the internal lumen of the housing beyond the second blood outlet opening to the outer surface of the housing.

[0022] In Example 27, in the percutaneous circulatory assist system described in Example 26, the channel includes an inclined first end. In Example 28, in the percutaneous circulatory assist system described in Example 26, the channel includes a rounded first end.

[0023] In Example 29, in the percutaneous circulatory assist system described in Example 26, the channel includes a substantially flat surface for supporting the guide wire. In Example 30, in the percutaneous circulatory assist system described in Example 26, the housing further includes a first housing portion proximal to the channel and a second housing portion distal to the channel, the first housing portion having a first diameter, the second housing portion having a second diameter, the first diameter being smaller than the second diameter, and a tapered housing portion extending between the first and second housing portions, and the channel is located within the tapered housing portion.

[0024] In Example 31, in the percutaneous circulatory assist device described in Example 30, the channel includes a first side wall and a second side wall, and the first side wall and the second side wall are configured to form a flared opening adjacent to the first housing portion.

[0025] In Example 32, a method for using a percutaneous circulatory assist device includes inserting a distal end of a guide wire into a patient's vasculature and inserting a proximal end of the guide wire into a housing of the device, the housing including an internal lumen, an impeller within the internal lumen, an outer surface, and a blood outlet including a blood outlet opening, the blood outlet opening including a channel that extends from the internal lumen of the housing to the outer surface of the housing and is configured to receive and support the guide wire without damage, passing the proximal end of the guide wire through the internal lumen of the housing, passing the proximal end of the guide wire adjacent to the impeller, and passing the proximal end of the guide wire through the channel of the blood outlet opening such that the guide wire extends from the internal lumen of the housing to the outer surface of the housing.

[0026] In Example 33, in the method described in Example 32, the channel is located in a proximal portion of the blood outlet opening. In Example 34, in the method described in Example 33, the blood outlet opening is a first blood outlet opening, the housing includes a second blood outlet opening, and the channel extends proximally beyond the second blood outlet opening.

[0027] In Example 35, in the method described in Example 32, the method further includes moving the device along the guide wire and inserting the device into the patient's vasculature. Although multiple embodiments are disclosed, further other embodiments of the present invention will be apparent to those skilled in the art from the following detailed description which illustrates and describes exemplary embodiments of the present invention. Accordingly, the drawings and the detailed description are to be regarded as illustrative in nature and not restrictive.

Brief Description of the Drawings

[0028]

Figure 1

Figure 2A

Figure 2B

Figure 2C

Figure 3

Figure 4

[0029] The present invention is subject to various modifications and alternative forms, and specific embodiments have been shown by way of example in the drawings and will be described in detail below. However, the intention is not to limit the present invention to the particular embodiments described. On the contrary, the present invention is intended to cover all modifications, equivalents, and alternative forms falling within the scope of the present invention as defined by the appended claims.

DETAILED DESCRIPTION OF THE INVENTION

[0030] FIG. 1 shows a partial side cross-sectional view of an exemplary percutaneous circulatory assist device 100 (also interchangeably referred to herein as a “blood pump”) according to an embodiment of the subject matter disclosed herein. The device 100 may form part of a percutaneous circulatory assist system, along with a guide wire (shown elsewhere) and an introducer sheath (shown elsewhere). More specifically, the guide wire and the introducer sheath may facilitate percutaneous delivery of the device 100 to a target location within a patient (e.g., within the patient's heart, etc.). Alternatively, the device 100 may be delivered to a different target location within the patient.

[0031] Continuing to refer to FIG. 1, the device 100 generally includes a housing 101 that includes an impeller housing 102 and a motor housing 104. In some embodiments, the impeller housing 102 and the motor housing 104 may be constructed integrally or monolithically. In other embodiments, the impeller housing 102 and the motor housing 104 may be separate components configured to be removably or permanently coupled. In some embodiments, the blood pump 100 may lack a separate motor housing 104, the impeller housing 102 may be directly coupled to the motor 105 described below, or the motor housing 104 may be constructed integrally with the motor 105 described below. The impeller housing 102 includes an internal lumen 102a, an inner surface 102b, and an outer surface 102c. Similarly, the motor housing 104 includes an internal lumen 104a, an inner surface 104b, and an outer surface 104c. A central axis 103 extends longitudinally through the housing 101.

[0032] The impeller housing 102 houses an impeller assembly 106 therein. The impeller assembly 106 includes an impeller shaft 108 that is rotatably supported by at least one bearing such as a bearing 110. The impeller assembly 106 also includes an impeller 112 that drives blood through the device 100 by rotating with respect to the impeller housing 102. More specifically, the impeller 112 causes blood to flow out from a blood inlet 114 formed on the impeller housing 102, through the impeller housing 102, and out of a blood outlet 116 formed on the impeller housing 102. In some embodiments, as shown, the impeller shaft 108 and the impeller 112 may be separate components, and in other embodiments, the impeller shaft 108 and the impeller 112 may be integrated. In some embodiments, as described in more detail below, the inlet 114 and / or the outlet 116 may each include a plurality of openings (see, e.g., FIGS. 2-4). In other embodiments, the inlet 114 and / or the outlet 116 may each include a single opening. In some embodiments, as shown, the inlet 114 may be formed at an end of the impeller housing 102, and the outlet 116 may be formed at a side of the impeller housing 102. In other embodiments, the inlet 114 and / or the outlet 116 may be formed at other portions of the impeller housing 102. In some embodiments, the impeller housing 102 may be connected to a distally extending cannula (not shown), and the cannula may receive blood and deliver it to the inlet 114.

[0033] Continuing to refer to FIG. 1, the motor housing 104 houses the motor 105, and the motor 105 is configured to rotatably drive the impeller 112 with respect to the impeller housing 102. In the illustrated embodiment, the motor 105 rotates the drive shaft 120 connected to the drive magnet 122. The rotation of the drive magnet 122 causes the rotation of the passive magnet 124, which is connected to and rotates with the impeller assembly 106. More specifically, in an embodiment incorporating the impeller shaft 108, the impeller shaft 108 and the impeller 112 are configured to rotate with the passive magnet 124. In other embodiments, the motor 105 can be connected to the impeller assembly 106 via other components.

[0034] In some embodiments, a controller (not shown) may be operably connected to the motor 105 and configured to control the motor 105. In some embodiments, the controller may be disposed within the motor housing 104. In other embodiments, the controller may be disposed outside the motor housing 104 (e.g., within a separate housing, etc.). In some embodiments, the controller may include a plurality of components, one or more of which may be disposed within the motor housing 104. According to an embodiment, the controller may be one or more field programmable gate arrays (FPGAs), one or more programmable logic devices (PLDs), one or more complex PLDs (CPLDs), one or more custom application specific integrated circuits (ASICs), one or more dedicated processors (e.g., microprocessors), one or more central processing units (CPUs), software, hardware, firmware, or any combination of these and / or other components, may include them, or may be included in them. Although the controller is referred to herein in the singular, the controller may be implemented in multiple instances, may be distributed across multiple computing devices, may be instantiated within multiple virtual machines, and / or the like. In other embodiments, the motor 105 may be controlled in other ways.

[0035] Continuing to refer to FIG. 1 and further referring to FIG. 2A, device 100 facilitates the passage of a guide wire (shown elsewhere) through device 100 by incorporating channel 126 within blood outlet opening 128 of blood outlet 116. As described above, blood outlet 116 may include two or more openings. For example, as shown in FIG. 2A, blood outlet 116 includes six blood outlet openings 128, 130, 131, 132, 133, and 134. As shown in FIG. 2A, blood outlet opening 128 includes a proximal portion 136 and a distal portion 138. In some embodiments, as shown in FIG. 2A, channel 126 is located in proximal portion 136 of blood outlet opening 128. In other embodiments, channel 126 may be located in other portions of the blood outlet opening, such as distal portion 138. As shown in FIG. 2A, channel 126 extends in a proximal direction from blood outlet opening 128. Also, as shown in FIG. 2A, channel 126 extends in a proximal direction beyond each of the other blood outlet openings 130, 131, 132, 133, and 134, thus indicating to the user that the guide wire should be passed through blood outlet opening 128 rather than the other blood outlet openings 130, 131, 132, 133, and 134. Additional indicia, such as markings or letters, may be disposed near channel 126 to indicate the proper position of the guide wire. Channel 126 has a width 140 and a length 142. Width 140 is generally no narrower than the width of the guide wire. In some embodiments, length 142 may vary from 0.0635 cm (0.025 inches) to 0.953 cm (0.375 inches).

[0036] In the embodiments of FIGS. 2A-2C, channel 126 includes a first end portion 144 at the distal end 146 of channel 126, i.e., where channel 126 contacts inner surface 102b. Similarly, in the embodiments of FIGS. 2A-2C, channel 126 also includes a second end portion 148 at the proximal end 150 of channel 126 where channel 126 contacts outer surface 104c. FIG. 2B shows a first end portion 144b that has not been inclined, chamfered, rounded, or otherwise mechanically modified to smooth the first end portion 144a. In contrast, in some embodiments, the first end portion 144 and / or the second end portion 148 may be inclined, chamfered, rounded, or otherwise mechanically modified to smooth the first end portion 144 and the second end portion 148. For example, as shown in FIG. 2C, the first end portion 144c is rounded to smooth the first end portion 144c. In some embodiments, channel 126 may include fewer or additional edges or surfaces than shown in FIGS. 2A-2C, and some or all of such edges or surfaces may be smoothed by inclination, chamfering, rounding, or other mechanical modifications. As further shown in FIGS. 2A-2C, in some embodiments, channel 126 includes a first sidewall 152 and a second sidewall 154 separated by a width 140, both of which extend along a length 142 and flare away from each other to form a flared opening 158 adjacent to the distal end 146 of channel 126. The flare opening 158 may have a width of, for example, up to 120 degrees. In some embodiments, the first sidewall 152 and the second sidewall 154 may be inclined, chamfered, rounded, or otherwise mechanically modified to smooth the surfaces of the first sidewall 152 and the second sidewall 154. For example, as shown in FIG. 2C, the second wall 154c is rounded. In other embodiments, the first sidewall 152 and the second wall 154 may remain unmodified as shown in the second wall 154b of FIG. 2B.

[0037] As shown in FIGS. 2A - 2C and 3, channel 126 also includes a substantially flat surface 156 that extends between end portions 144, 148 and side walls 152, 154. Surface 156 may be slightly inclined or tapered from proximal end 150 and distal end 146, but in the embodiments shown in FIGS. 2 and 3, surface 156 is substantially flat so as to support guide wire 200 along channel 126. Guide wire 200 includes a distal end (not shown) and a proximal end 202 and may be made of one or more metals, one or more plastics, or a composite material, among others. In some embodiments, guide wire 200 may include a coating (not shown) that facilitates tracking and reduces friction within a patient's vasculature while advancing device 100 over guide wire 200 or advancing guide wire 200 through device 100. Such coatings may include PTFE, polymeric coatings, or ceramic coatings by chemical vapor deposition processes such as atomic layer deposition.

[0038] In conventional circulatory assist devices, when a guide wire passes through an opening of the circulatory assist device or when the device moves along the guide wire, the guide wire can be damaged by contact between the guide wire and the device housing. For example, if the housing is made of a metallic material and the guide wire is composed of a softer material or includes a coating, the guide wire can be damaged or the coating on the guide wire can be scraped off during contact with a relatively sharp housing surface. Also, in conventional circulatory assist devices, when the guide wire transitions from the inside to the outside of the device housing, the guide wire can be bent at a relatively large angle.

[0039] In contrast to conventional devices, in device 100, since guide wire 200 passes through channel 126, the potential for damage is substantially reduced. In particular, the above-described configuration of channel 126 substantially reduces the possibility that the coating on guide wire 200 is scraped off or damaged. In addition, the above-described configuration of channel 126 minimizes the amount by which guide wire 200 is deformed or bent when guide wire 200 transitions from the inner lumen 102a of impeller housing 102 to the outer surface 104c of motor housing 104, provides a flatter profile to guide wire 200, and thus, as shown in FIG. 4, has the advantage of reducing the space occupied within introduction sheath 300. Also, the flatter profile of guide wire 200 enables device 100 to be moved more easily along guide wire 200, including passing through introduction sheath 300 and blood vessel V.

[0040] The above-described configuration of channel 126 facilitates receiving and supporting guide wire 200 without damage as guide wire 200 passes through blood outlet opening 128. Specifically, as shown in FIG. 3, channel 126 within blood outlet opening 128 provides a relatively smooth surface for guide wire 200 to pass from the inner lumen 102a of impeller housing 102 to the outer surface 104c of motor housing 104. By incorporating inclined, chamfered, rounded, or other modified first and second ends 144, 148, first and second side walls 152, 154, and flare-shaped openings 152 and substantially flat surfaces 156, the likelihood that guide wire 200 is damaged as guide wire 200 passes through blood outlet opening 128 or as device 100 is moved along guide wire 200 is reduced compared to other blood outlet openings such as blood outlet openings 130, 131, 132, 133, and 134 that do not include such a configuration. For example, channel 126 reduces the possibility that the coating on the surface of guide wire 200 is scraped off as guide wire 200 passes through blood outlet opening 128 or as device 100 is moved along guide wire 200.

[0041] In addition, as shown in FIG. 3, when the guide wire 200 passes from the internal lumen 102a of the impeller housing 102 to the outer surface 104c of the motor housing 104, the above-described configuration of the channel 126 minimizes the amount by which the guide wire 200 is deformed or bent. Stated another way, by lengthening the transition region from the internal lumen 102a of the impeller housing 102 to the outer surface 104c of the motor housing 104, the guide wire 200 presents a flatter profile compared to a guide wire that transitions at another blood outlet opening, such as the blood outlet openings 130, 131, 132, 133, and 134, that do not include a configuration such as the channel 126. As described above, the flatter profile of the guide wire reduces the space occupied by the guide wire within the introduction sheath 300 and facilitates movement of the device 100 along the guide wire 200.

[0042] Continuing to refer to FIGS. 2A-2C and 3, in some embodiments, the impeller housing 102 has an outer diameter that is larger than the outer diameter of the motor housing 104. In alternative embodiments, the outer diameter of the impeller housing 102 may be substantially equal to the outer diameter of the motor housing 104, for example, when the impeller housing 102 and the motor housing 104 are integrally or monolithically constructed. In still other embodiments, the outer diameter of the motor housing 104 may be larger than the outer diameter of the impeller housing 102. As shown in FIGS. 2A-2C and FIG. 3, a tapered housing portion 160 extends between the impeller housing 102 and the motor housing 104. The tapered housing portion 160 forms a smooth transition along the housing 101 from the larger outer diameter of the impeller housing 102 to the relatively smaller outer diameter of the motor housing 104. As shown in FIGS. 2A-2C and FIG. 3, the channel 126 is located within the tapered housing portion 160 and is configured to facilitate the passage of the guide wire 200 from the internal lumen 102a of the impeller housing 102 to the outer surface 104c of the motor housing 104. More specifically, in the embodiments shown in FIGS. 2A-2C and FIG. 3, when the guide wire 200 passes from the internal lumen 102a of the impeller housing 102 to the outer surface 104c of the motor housing 104, the channel 126 is designed to minimize the amount by which the guide wire 200 is deformed or bent. Stated another way, as shown in FIGS. 3 and 4, when the channel 126 is incorporated into the device 100 having the tapered housing portion 160, the guide wire 200 extends along the outer surface 104c of the motor housing 104, passes through the blood outlet opening 128, and enters the internal lumen 102a of the impeller housing 102 while maintaining the same or a similar distance from the central axis 103 of the housing 101.

[0043] In other embodiments, other portions of the blood outlet 128, other than the proximal portion 136 of the opening, may include a channel or similar structure for receiving and supporting a guide wire without causing damage. For example, the distal portion 138 of the blood outlet opening 128 may include a channel or similar structure for receiving and supporting a guide wire without causing damage. In such embodiments, the inner surface 102b of the impeller housing 102 at the distal portion 138 may be configured to receive the guide wire, such as by including a form similar to the channel 126 described above. In other embodiments, the inner surface 102b of the impeller housing 102 at the distal portion 138 may be modified, deformed, rounded, or otherwise configured to receive and support a guide wire without causing damage. Additionally, in other embodiments, a portion of the entire blood outlet opening may be coated or surface treated to prevent damage to the guide wire. Further, in other embodiments, other openings, such as one or more of the openings of the blood flow inlet 114, may include a channel or similar structure, such as the channel 126, for receiving and supporting a guide wire without causing damage.

[0044] Figures 2A - 2C, 3, and 4 facilitate the explanation of the method by which the blood pump 100 is used with the guide wire 200 and the advantages brought about by the above-described configuration of the housing 101 including the channel 126. In an exemplary procedure, the introducer sheath 300 is inserted into a blood vessel (not shown), and the guide wire 200 is inserted through the introducer sheath 300 such that the proximal end 202 of the guide wire 200 is located outside the introducer sheath 300 and outside the patient's body. The distal end (not shown) of the guide wire 200 is disposed distally from the introducer sheath 300 and is located within the patient's vasculature, for example, within the left ventricle of the heart. Then, the blood pump 100 is coupled to the guide wire 200 by feeding the proximal end 202 of the guide wire 200 through an opening within the blood pump 100 such as the blood inlet 114. Next, the proximal end 202 of the guide wire 200 passes through the housing 101, for example, through the internal lumen 102a of the impeller housing 102, through the impeller 112, and out of the blood pump 100 through another opening such as the blood outlet 116, and in particular, through the blood outlet opening 128 as shown in FIGS. 3 and 4. When the guide wire 200 passes through the blood outlet opening 128, the guide wire 200 is received and supported by the channel 126, thereby suppressing damage to the guide wire 200 when the guide wire 200 contacts the housing 101. FIG. 4 specifically shows the guide wire 200 extending proximally from the blood outlet opening 128, for example, along the outer surface 104c of the motor housing 104 and within the introducer sheath 300 and the blood vessel V. Once coupled to the guide wire 200, the blood pump 100 can be moved through the introducer sheath 300 along the length of the guide wire 200 so as to insert the device 100 into the blood vessel V and ultimately into the patient's heart.

[0045] Without departing from the scope of the present invention, various modifications and additions can be made to the exemplary embodiments discussed. For example, although the above-described embodiments refer to specific 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 embrace all such alternative, modified, and variant forms falling within the scope of the claims, together with all their equivalents.

Claims

1. A percutaneous circulatory assist device for use with a guide wire, comprising a housing including an internal lumen, an outer surface, a blood inlet, and a blood outlet including a blood outlet opening, wherein the blood outlet opening includes a channel extending from the internal lumen of the housing to the outer surface of the housing, the channel being configured to receive and support the guide wire without damage, and having a tapered surface along the outer surface of the housing proximal to the blood outlet opening. The percutaneous circulatory assist device.

2. The device is an impeller disposed within the internal lumen, the impeller being configured to rotate relative to the housing to cause blood to flow into the blood inlet and out of the blood outlet through the internal lumen of the housing; and a motor operably coupled to the impeller and configured to rotatably drive the impeller. The percutaneous circulatory assist device according to claim 1, further comprising.

3. The blood outlet opening is a first blood outlet opening, the blood outlet includes a second blood outlet opening, and the channel extends proximally beyond the second blood outlet opening. The percutaneous circulatory assist device according to claim 1.

4. The channel includes an inclined first end. The percutaneous circulatory assist device according to claim 1.

5. The channel includes a rounded first end. The percutaneous circulatory assist device according to claim 1.

6. The channel has a width greater than that of the guide wire. The percutaneous circulatory assist device according to claim 1.

7. The channel has a length of 0.0635 cm (0.025 inches) to 0.953 cm (0.375 inches), and the percutaneous circulatory assist device according to claim 1.

8. The channel includes a substantially flat surface for supporting the guide wire, and the percutaneous circulatory assist device according to claim 1.

9. The channel is located at a proximal portion of the blood outlet opening, and the percutaneous circulatory assist device according to claim 1.

10. The housing is a first housing portion on the proximal side of the channel and a second housing portion on the distal side of the channel, the first housing portion has a first diameter, the second housing portion has a second diameter, and the first housing portion and the second housing portion where the first diameter is smaller than the second diameter, and further includes a tapered housing portion extending between the first housing portion and the second housing portion, and the channel is located within the tapered housing portion, and the percutaneous circulatory assist device according to any one of claims 1 to 9.

11. The channel includes a first side wall and a second side wall, and the first side wall and the second side wall are configured to form a flared opening adjacent to the first housing portion, and the percutaneous circulatory assist device according to claim 10.

12. The outer surface of the housing has markings near the channel, and the percutaneous circulatory assist device according to claim 1.

13. A percutaneous circulatory assist device for use with a guide wire, comprising a housing including an internal lumen, an outer surface, a blood inlet, and a blood outlet including a plurality of blood outlet openings, One of the plurality of blood outlet openings includes a channel that extends from the internal lumen of the housing to the outer surface of the housing on the proximal side of the blood outlet opening, and the channel is configured in a tapered shape along the outer surface of the housing so as to receive and support the guide wire without causing damage, a percutaneous circulatory assist device.

Citation Information

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