Outflow pipe and outflow pipe assembly

Abstract

The present invention provides an integrated outflow tube balloon that is separate or part of another device, and a method of manufacturing the device. The balloon may include a flexible tubular polymer layer having a distal end and a proximal end, and having an outer surface and an inner surface. The balloon may include one or more openings at the proximal end that extend from the outer surface to the inner surface. The balloon may include a slot extending from a proximal end to a proximal end of one of the one or more openings. The balloon may include a distal end configured to be disposed on the inflatable housing.

Description

[0001] CROSS-REFERENCE TO RELATED APPLICATIONS

[0002] This application claims priority to US 63 / 438,881, filed January 13, 2023, the entire contents of which are incorporated herein by reference. Technical Field

[0003] The present disclosure relates to an outflow tube for a catheter-based heart pump. Background Art

[0004] In catheter-based heart pumps, outflow tubes are used to control the flow of blood after it leaves the pump housing. However, the design of these outflow tubes means that the manufacturing process for producing them and securing them to the heart pump is complex. This complexity can lead to defects. Summary of the Invention

[0005] The systems and techniques of the present invention improve upon the prior art in various ways.

[0006] In some embodiments, an integrated outflow tube balloon can be provided. The integrated outflow tube balloon can include one or more openings at a proximal end of the balloon. The balloon can include a slot extending from the proximal end of the balloon to a proximal end of one of the one or more openings. The balloon can include a midsection configured to be operably coupled to the expandable housing. The balloon can include a distal portion configured to serve as an inflow net.

[0007] In some embodiments, an outflow tube assembly can be provided, wherein the outflow tube assembly can include an integral outflow tube balloon as disclosed herein operably coupled to an expandable shell and / or an inner coating of the shell.The shell can include a filter portion at the inflow.

[0008] In some embodiments, a medical device can be provided, wherein the medical device can include an integrated outflow tube balloon as disclosed herein operably coupled to a catheter at a proximal end and operably coupled to an expandable shell and / or an inner coating of the shell.

[0009] In some embodiments, a method for manufacturing a device, wherein the method may include: producing a first subassembly by providing an inner coating onto a core shaft, producing a second subassembly by providing an expandable shell on the inner coating, producing a third subassembly by disposing an integral outflow tube balloon on the shell and the inner coating, coupling the inner coating and the shell to a portion of the integral outflow tube balloon (via, for example, heat welding), and optionally, removing a portion of the integral outflow tube balloon to form an inflow mesh. BRIEF DESCRIPTION OF THE DRAWINGS

[0010] The accompanying drawings, which are incorporated in and constitute a part of this specification, illustrate embodiments of the invention and, together with the general description of the invention given above and the detailed description of the embodiments given below, serve to explain the principles of the invention.

[0011] Figure 1 is a diagram of the outflow tube assembly.

[0012] Figure 2 is a diagram of the inner coating.

[0013] Figure 3 is a diagram of the shell.

[0014] Figure 4 is an illustration of the outflow tube balloon.

[0015] Figure 5 yes Figure 4 A cross-sectional view of the inflow area of ​​an expandable housing with an expandable filter mounted thereon and also showing the inner coating.

[0016] Figure 6 is a side view of the housing, outlet tube, and expandable filter.

[0017] Figure 7 yes Figure 6 Perspective view of the inflow area of ​​the expandable shell.

[0018] Figure 8 It is a flow chart of the manufacturing process of the outflow pipe.

[0019] 9A is a front view of an embodiment of an outflow tube balloon.

[0020] 9B is a rear view of an embodiment of an outflow tube balloon.

[0021] 9C is a top view of an embodiment of an outflow tube balloon.

[0022] 9D is a bottom view of an embodiment of an outflow tube balloon.

[0023] 9E is a right side view of an embodiment of an outflow tube balloon.

[0024] 9F is a left side view of an embodiment of an outflow tube.

[0025] It should be understood that the drawings are not necessarily drawn to scale and present somewhat simplified representations of various features illustrating the basic principles of the invention. Specific design features of the operational sequences disclosed herein, including, for example, the specific dimensions, orientations, positions, and shapes of the various illustrated components, will be determined in part by the specific intended application and use environment. Certain features of the illustrated embodiments have been enlarged or distorted relative to other features to facilitate visualization and clear understanding. In particular, thin features may be thickened, for example, for clarity or illustration. DETAILED DESCRIPTION

[0026] The following description and accompanying drawings only illustrate the principles of the present invention. Therefore, it should be understood that those skilled in the art will be able to design various arrangements, which, although not explicitly described or shown in this article, embody the principles of the present invention and are included within the scope thereof. In addition, all examples described herein are primarily intended to be used for illustrative purposes only, to help the reader understand the principles of the present invention and the concepts contributed by the inventors to promote this area, and should be interpreted as not being limited to the examples and conditions of these specific descriptions. In addition, unless otherwise specified (e.g., "otherwise" or "or in the alternative"), the term "or" as used herein refers to non-exclusive or. In addition, the various embodiments described herein are not necessarily mutually exclusive, as some embodiments can be combined with one or more other embodiments to form new embodiments.

[0027] Many innovative teachings of the present application will be described with particular reference to currently preferred exemplary embodiments. However, it should be understood that such embodiments only provide several examples of the many advantageous uses of the innovative teachings herein. Generally, the statements made in the specification of the present application do not necessarily limit any of the various claimed inventions. In addition, some statements may apply to some inventive features but not to other features. Those skilled in the art and those skilled in the art who have learned from the teachings herein will recognize that the present invention is also applicable to various other technical fields or embodiments.

[0028] Improved outflow tubes can be provided whereby various components or manufacturing steps can be avoided. For example, in various embodiments, two heat welding transitions can be avoided, an outer coating can be eliminated, four machining aids (e.g., various mandrels or other tools used during manufacturing) can be eliminated, and excess outflow tube can be eliminated from the process during or after manufacturing.

[0029] refer to Figure 1 , the outflow tube assembly can be seen. The outflow tube assembly 1 can include an inner coating 10. The inner coating can be provided on the inner surface of the expandable shell 20. Note that, Figure 1 The expandable shell surrounding the inner coating is not shown for ease of understanding. Figure 3 An example of a typical expandable shell is shown.

[0030] Because these devices are configured to be placed, for example, into a patient's blood vessel, the housing can have an inlet 23 configured to allow blood to enter the housing, an outlet 25 configured to allow blood to exit the housing, and can have an intermediate portion 24 extending between a proximal end of the inlet and a distal end of the outlet. The housing can have a proximal portion 26 extending proximally from the proximal end of the outlet. The proximal portion can be configured to be coupled to a catheter (not shown). The housing can have a distal portion 29 extending distally from the distal end of the inlet.

[0031] exist Figure 2 and Figure 3 A simplified embodiment of these two elements (inner coating and expandable shell) can be seen in FIG.

[0032] Inner coating 10 Figure 2 1 is shown as being generally cylindrical about a central axis 99, having an axial length 11, an inner diameter 12, and a thickness 13. In some embodiments, the axial length can be equal to the axial length of the intermediate portion 24 of the housing. That is, in some embodiments, the axial length 11 can be equal to the axial distance 28 between the proximal end of the inlet and the distal end of the outlet (see FIG. Figure 4 A). In some embodiments, the axial length can be less than the axial length of the mid-section. The inner diameter is typically smooth to reduce any impact on blood flow through the mid-section.

[0033] Figure 3 An embodiment of an expandable shell 20 is shown in FIG. The shell 20 can have a distal end 21 and a proximal end 22. The shell can be formed at least in part by a plurality of struts 27 configured to form an inlet 24, an outlet 26, and an intermediate portion extending between the proximal end of the inlet and the distal end of the outlet. The intermediate portion can have an axial length 28. The shell can include a proximal portion 26 formed proximal to the outlet, which can be formed by the struts. The shell can include a distal portion 29 formed distal to the inlet, which can be formed by the struts.

[0034] The housing may be radially expandable. The inlet, the middle portion, and the outlet of the housing may be configured to have a compressed state and an expanded state. The housing may be configured to be wrapped around a catheter (not shown).

[0035] If the shell is expandable, it can include a plurality of struts made of a compatible shape memory material, a superelastic material, or a pseudoelastic material, such as Nitinol. Superelastic materials are typically elastomers. Most such elastomers can achieve elastic deformations up to approximately 100%, while some pseudoelastic materials can achieve elastic deformations of approximately 6-8%. Nitinol is the trade name for a nickel-titanium alloy that is distinguished from other materials by its shape memory and pseudoelastic properties.

[0036] The struts may be made of wire or other filaments. The housing is typically constructed to surround an impeller positioned within the housing (see Figure 5 The impeller 200 in the housing forms a "cage-like structure." When radially expanded, the length of the housing can be less than when radially compressed. This change in length results from the expansion of the struts as the housing expands. In some embodiments, the change in length from a compressed state to an expanded state can be approximately 1-2 mm.

[0037] In some embodiments, the proximal portion can include a connector 50, which can be a rigid connector coupled to one or more struts. The connector can define a lumen (not shown) extending from a proximal end of the connector to a distal end. The connector can be configured with one or more openings 51 extending from an outer surface to an inner surface of the connector. The connector can be configured to couple to a catheter (not shown).

[0038] The outflow tube assembly 1 may include a coupled outflow tube balloon 30, at least a portion 31 of which is configured to be operably coupled to the housing and / or inner coating. The outflow tube balloon may be flexible. In some embodiments, the outflow tube balloon may comprise a polymer, such as PET or PU. The thickness of the outflow tube balloon may be, for example, about 10 μm to about 100 μm thick. The thickness of the outflow tube balloon may vary in the axial direction. The outflow tube balloon may be formed using, for example, a blow molding manufacturing process.

[0039] The outflow tube balloon can include one or more openings 35 extending from an outer surface 36 to an inner surface 37 of the outflow tube balloon. In some embodiments, the one or more openings can have the same shape. In some embodiments, the one or more openings can have different shapes. The outflow tube can be configured to be coupled to a catheter (not shown) at a proximal end 32, which is positioned in a position similar to a mandrel.

[0040] The outflow tube balloon is configured to surround and be positioned adjacent to the outflow tube of the housing. In this manner, blood flowing out of the outflow port will enter the volume defined by the inner surface of the outflow tube balloon and will flow in a generally axial direction toward the one or more openings, where it will exit the outflow tube and return to the blood vessel.

[0041] To aid in assembly and manufacturing, the outflow tube can include a slot 40 or slit extending from the proximal end through a portion of the outflow tube balloon to one of the one or more openings 35. In some embodiments, the slot can include a straight portion 41 extending axially from the proximal end toward a triangular portion 38 of the one or more openings 35, where the apex of the triangular portion connects to the slit.

[0042] The one or more openings may include a plurality of openings. In some embodiments, each opening is spaced the same circumferential distance from an adjacent opening. In some embodiments, at least a first opening is spaced the same circumferential distance from an adjacent opening as a second opening (e.g., the openings may not be equally spaced around the circumference of the outflow tube balloon). In some embodiments, there may be 3 to 8 openings. In some embodiments, there may be 3 to 4 openings. In some embodiments, there may be 4 openings.

[0043] exist Figure 5 , the disclosed outflow tube can be seen in conjunction with a medical device. The medical device can be, for example, a blood pump, such as a catheter-type blood pump.

[0044] Impeller 200 is shown located inside housing 20 and is mechanically coupled to a proximally located motor (not shown) via a flexible drive shaft 202 .

[0045] The inner center portion of the housing 20 may have an inner coating 10 that defines a channel through which the impeller 200 pumps blood. Proximally and distally of the channel, the housing 20 allows blood to be drawn into the housing through the inlet 23 and pushed out of the housing through the outlet 25 into the downstream portion of the outflow tube balloon 30. The housing may include a proximal tapered housing portion 502 adjacent to the intermediate housing portion 24.

[0046] In some embodiments, the housing can include an inflow net or filter portion. In some embodiments, the housing can include a portion disposed on the outside of the housing that forms an expandable filter 530. In some embodiments, the filter 530 can include a distal tubular filter section 514 and a proximal tubular filter section 516, wherein the distal tubular filter section 514 has a relatively small diameter and the proximal tubular filter section 516 has a larger diameter (in its expanded state). The exact cross-sectional shape of the filter 530 (including the exact cross-sectional shape of the distal tubular filter section 514 and the proximal tubular filter section 516) can depend on the number of struts in the housing and / or filter. Typically, the cross-sectional shape can be polygonal, possibly with rounded corners. The distal tubular filter section 514 can be disposed on top of the distal support 512.

[0047] In some embodiments, the distal end of the outflow tube balloon can be heat sealed, such as by welding, through one or more holes defined by the struts of the distal tubular filter section 514 to extend to the proximal section of the flexible atraumatic tip 599.

[0048] like Figure 6As seen in FIG, in some embodiments, the expandable filter 530 may include a transition region 724 where the distal tubular filter segment 514 and the conical filter segment 518 meet. The apertures in the transition region 724 (illustrated by apertures 726) are longer and wider than the adjacent apertures in the conical filter segment 518. Preferably, the apertures 726 in the transition region 724 are at least twice as large as the adjacent apertures in the conical filter segment 518 (illustrated by apertures 728). In one embodiment, for each pair of circumferentially adjacent apertures 728 in a row of conical filter segments 518, the transition region 724 has one aperture 726 that circumferentially spans both apertures 728. Thus, the number of apertures in the circumferential row in the transition region 724 is half the number of apertures in the circumferential row in the conical filter segment 518. In some other embodiments, other ratios may be used, such as 3:1, 4:1, or 3:2. Depending on the ratio of the number of holes 728 in a row of the conical filter section 518 to the number of holes 726 in a row of the transition zone 724, the length of each hole 726 in the transition zone 724 can be approximately two times, three times, or another multiple of the length of the hole 728 in the conical filter section 518 (in the longitudinal direction) and the width can be approximately two times, three times, or another multiple of the width of the hole 728 in the conical filter section 518 (in the circumferential direction).

[0049] The size and shape of the holes 702-706 and 728 and the size of the struts 714-716 should be selected so that when the conical filter section 518 is fully open, the inlet of the housing in its expanded state can be positioned within the conical filter section 518 without exceeding the elastic deformation limit of the material. For example, to account for any local elastic deformation of the filter material, the length of two circumferentially adjacent struts 714-716 (in the zigzag shape of the zigzag circumferential ring) multiplied by the number of holes 702-706 in the circumferential row should be approximately equal to the circumference of the fully expanded housing.

[0050] The openings 702-706 are positioned such that the material between the openings 702-706 (illustrated by materials 708, 710, and 712) forms a first strut and a second strut. Two exemplary struts 714 and 716 are located in the Figure 6 As indicated, the generally spiral curve may include small zigzags, not necessarily all the same, as illustrated by generally spiral curves 714 and 716. These zigzags may be Figure 6 This is more clearly seen in the insert in FIG. 7 , such as in struts 718 and 720 , which are indicated by thick solid and dashed lines.

[0051] Adjacent pores 726 in the transition region 724 are separated from each other by struts that are wider than the adjacent struts 714-716 of the tapered filter section 518. These wider struts stabilize the larger pores 726. When the distal portion 520 of the outflow tube balloon is placed on the distal tubular filter section 514, longitudinally proximal to the transition region 724, the distal portion 520 at least partially covers the first row or rows of pores 726 in the transition region 724, thereby reducing its effective size. In some cases, this reduced pore size may lead to blood damage or increased clotting risk. Therefore, the pores 726 in the transition region 724 should be selected to be larger than the pores in the tapered filter section 518.

[0052] If you can Figure 6 and Figure 7 As seen in FIG, the apertures 728 in the distal region of the conical filter segment 518 are narrower in the circumferential direction than the openings 702-706 in the proximal region of the conical filter segment 518. In other words, the size of the openings 702-706 increases monotonically in the proximal direction along the longitudinal axis. Furthermore, in the distal tubular filter segment 514, the apertures 722 are in the form of narrow axial slits that are offset from one another in the circumferential direction. This is advantageous because the narrow apertures may widen when the expandable filter 530 expands at the distal regions of the distal tubular filter segment 514 and the conical filter segment 518, for example, when the impeller 200 is inserted into the housing. The wider apertures are defined by thicker struts, particularly in the conical filter segment 518. The struts have a width between approximately 30 μm in the distal region of the conical filter segment 518 and approximately 60 μm in the proximal region. Preferably, the maximum diameter of the pores in the conical filter section 518 is between about 300 μm and about 500 μm.

[0053] exist Figure 6 and Figure 7 In the embodiment shown, the proximal tubular filter section 516 has no holes. However, holes in the proximal tubular filter section 516 may be desirable, such as when an integrated outflow tube balloon 30 is placed over the proximal tubular filter section 516 (see FIG. Figure 5 ), the proximal tubular filter section 516 is then located on the middle / intermediate housing portion 24.

[0054] Thus, in some embodiments, the portion of the outflow tube disposed around the inlet may include a plurality of openings that align with openings of the inlet 23 and / or the filter 530 .

[0055] refer to Figure 2 A method for manufacturing such a device can be seen. The method 100 can include a first step of assembling 110 an inner coating onto a mandrel, thereby forming a first subassembly.

[0056] The method may include a second step of assembling 120 the housing onto the first subassembly, thereby forming a second subassembly

[0057] The method may include inserting 130 the outflow tube balloon, wherein the distal end of the mandrel enters the proximal end of the outflow tube balloon, and the outflow tube balloon is then brought to the proximal end of the second subassembly until the outflow tube balloon is properly positioned, thereby forming a third subassembly.

[0058] The method may include a step 140 of coupling the outflow tube balloon to the housing and / or inner coating, and / or ablating the outflow tube balloon. Specifically, the outflow tube balloon may be coupled to the housing and / or inner coating via a suitable method, such as thermal bonding. The outflow tube balloon may be ablated, for example, by laser ablation, to cut a design into at least a portion of the outflow tube balloon. This step forms the outflow assembly.

[0059] The method may include removing 150 the mandrel from the outflow assembly.

[0060] In some embodiments, various views of embodiments of an outflow tube balloon can be seen in Figures 9A-9F, prior to any laser ablation.

[0061] Various modifications may be made to the systems, methods, devices, mechanisms, techniques, and portions thereof described herein with respect to the various figures, and such modifications are considered to be within the scope of the present invention. For example, while a particular order of steps or arrangement of functional elements is presented in the various embodiments described herein, various other orders / arrangements of steps or functional elements may be utilized in the context of the various embodiments. Furthermore, while modifications to an embodiment may be discussed individually, various embodiments may utilize multiple modifications, composite modifications, etc., simultaneously or sequentially.

[0062] Although various embodiments incorporating the teachings of the present invention have been shown and described in detail herein, those skilled in the art can readily devise numerous other variations of the present invention that still incorporate these teachings. Thus, although the foregoing is directed to various embodiments of the present invention, other and further embodiments of the present invention may be devised without departing from the basic scope of the present invention. Accordingly, the proper scope of the present invention will be determined in accordance with the claims.

Claims

1. An integrated outflow tube airbag, comprising: a flexible tubular polymeric layer having a distal end and a proximal end and having an outer surface and an inner surface; one or more openings at the proximal end, the one or more openings extending from the outer surface to the inner surface; a slot extending from the proximal end to a proximal end of one of the one or more openings; and A distal end is configured to be disposed on the expandable shell.

2. The integrated outflow tube airbag according to claim 1, wherein: The distal end is configured as an inflow mesh.

3. An outflow pipe assembly comprising: an expandable shell defining an inlet and an outlet; and an inner coating disposed between the inlet and the outlet against an inner surface of the expandable shell; and The integrated outflow tube balloon according to claim 1 or 2, wherein a portion of the integrated outflow tube balloon is operably coupled to the expandable shell and / or the inner coating.

4. The outflow tube assembly according to claim 3, wherein: The housing includes a filter portion at the inlet.

5. A medical device comprising: flexible tubular member; and The outflow tube assembly of claim 3 or 4, having a distal end and a proximal end, wherein the distal end and the proximal end are operably coupled to the flexible tubular member. The medical device of claim 5 , further comprising an impeller disposed within the outflow tube assembly.

7. A method of manufacturing a device, comprising: creating a first subassembly by providing an inner coating on a mandrel; creating a second subassembly by providing an expandable shell over said inner coating; creating a third subassembly by disposing an integral outflow tube balloon over the housing and the inner coating; forming the device by coupling the inner coating and the housing to a portion of an integral outflow tube balloon (via, for example, heat welding) and optionally removing a portion of the integral outflow tube balloon to form an inflow mesh; and The device is removed from the mandrel.

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