Intraluminal Modular Powered Medical System
Patent Information
- Authority / Receiving Office
- JP · JP
- Patent Type
- Applications
- Current Assignee / Owner
- Filing Date
- 2023-03-22
- Publication Date
- 2026-04-08
AI Technical Summary
Existing cardiac assist devices (VADs) require a lot of energy when providing blood pumping and the cross-sectional size of the power line occupies a large portion of the blood vessel lumen, resulting in blockage of blood flow and increasing the risk of downstream blood flow and tissue ischemia.
An intraluminal modular electrical medical system is designed, using a combination of dock electrical connectors and device electrical connectors to connect and disconnect electrical connections in the body through sliding operation of control elements, reducing the number and size of power lines, thereby reducing the occupation of the blood vessel lumen.
It effectively reduces the occupation of power lines on the blood vessel lumen, reduces the interference to blood flow, reduces the risk of downstream blood flow and tissue ischemia, and improves the operational safety of VAD.
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Abstract
Description
[Technical field]
[0001] CROSS-REFERENCE TO RELATED APPLICATIONS [1] This patent application claims the benefit of and priority to U.S. Provisional Patent Application No. 63 / 322,691, filed March 23, 2022, the entire contents of which, including all references incorporated by reference therein, if any, are incorporated by reference herein for all purposes as if fully set forth herein, except for any definitions, disclaimers or disclaimers of subject matter, and except to the extent the incorporated content is inconsistent with the express disclosure of this specification, in which case the language of the present disclosure will control.
[0002] Field [2] The present disclosure relates generally to an endoluminal modular powered medical system. [Background technology]
[0003] background [3] Ventricular assist devices (VADs) are commonly provided as left ventricular assist devices (LVADs), right ventricular assist devices (RVADs), or biventricular assist devices (BiVADs). Several designs of ventricular assist devices are known, including intraluminal modular powered medical systems with multiple pumps.
[0004] [4] To provide hemodynamic support, VADs are required to displace large volumes of blood, for example in the range of 1-5 liters per minute, and therefore often require significant amounts of energy to operate properly. Implanted VADs are therefore typically wired to a power source located outside the subject's vasculature and require power lines extending between the VAD and the power source.
[0005] [5] The power line often encloses one or more electrical cables or wires for transmitting power to one or more pumps and / or one or more mechanical drive systems for transmitting torque to one or more pumps. Thus, the cross-sectional size of the power line may occupy a substantial percentage of the lumen of the subject's vasculature in which the VAD is implanted, and thus the power line may impede blood flow within that lumen. This is especially true when the lumen of the subject's vasculature gradually shrinks downstream of the blood flow. The larger the cross-sectional area of the power line, the more blood flow is impeded. Similarly, the more power lines there are within the lumen of the vasculature, the more blood flow is impeded. For example, a multi-pump VAD design may require each pump to be wired to a power source, resulting in multiple power lines passing through the vasculature, either individually or as a bundle, to transmit power from the power source to the pumps. Summary of the Invention [Problem to be solved by the invention]
[0006] [6] Reduced or complete loss of blood flow downstream of power lines can lead to tissue ischemia and / or other complications. Ischemia, even if only temporary, can result in irreversible damage to tissue. For example, occlusion of femoral artery blood flow for several hours by a VAD implanted via a transfemoral approach can lead to limb ischemia and ultimately limb amputation. As the population ages, the atherosclerotic burden in peripheral vessels increases and the diameter of the vessel lumen decreases, further complicating the problem.
[0007] [7] Therefore, improvements to at least some of the known VADs are desirable. [Means for solving the problem]
[0008] overview [8] A first embodiment of the present disclosure is an endoluminal modular powered medical system, comprising: an intraluminal dock including at least one dock electrical connector configured to receive power from a power source; - an intraluminal medical device including at least one device electrical connector configured to intraluminally electrically connect to at least one dock electrical connector for receiving electrical power therefrom; The present invention relates to an intraluminal modular powered medical system including:
[0009] [9] The intraluminal medical device can include a control element configured to be attached to and extend from the intraluminal medical device, and the control element can be further configured to operate to connect together the at least one device electrical connector and the at least one dock electrical connector.
[0010]
[10] The control element can be configured to be removably attached to the intraluminal medical device.
[0011]
[11] The control element can be configured to extend from at least one device electrical connector.
[0012]
[12] The control element can be further configured to be in slidable relationship with the endoluminal dock, and the control element can be further configured to slidably actuate to connect together the at least one device electrical connector and the at least one dock electrical connector.
[0013]
[13] The endoluminal dock can include a control element passage guide that can be configured to slidably receive the control element along the control element passage guide to connect together the at least one device electrical connector and the at least one dock electrical connector.
[0014]
[14] The control element can have a proximal end portion configured to be manipulated outside the body by an operator to connect together the at least one dock electrical connector and the at least one device electrical connector.
[0015]
[15] The control element can be configured to be pulled to connect the at least one device electrical connector to the at least one dock electrical connector.
[0016]
[16] The control element can be configured to be depressed to connect the at least one device electrical connector to the at least one dock electrical connector.
[0017]
[17] The at least one device electrical connector and the at least one dock electrical connector can be configured to be removably connected together, and the control element can be further configured to be pulled to disconnect the at least one device electrical connector from the at least one dock electrical connector when the control element is connected to the at least one dock electrical connector.
[0018]
[18] The at least one device electrical connector and the at least one dock electrical connector can be configured to be removably connected together, and the control element can be further configured to be pressed to disconnect the at least one device electrical connector from the at least one dock electrical connector when connected to the at least one dock electrical connector.
[0019]
[19] The endoluminal dock can include a dock physics connector, and the endoluminal medical device can include a device physics connector configured to connect endoluminally to the dock physics connector.
[0020]
[20] The control element may be a guidewire.
[0021]
[21] The control element passage guide may be a guide hole.
[0022]
[22] The endoluminal dock may include an endoluminal extension configured to be attached to and extend from the endoluminal dock.
[0023]
[23] The intraluminal extension may include an electrical conductor configured to connect to a power source that provides power to the at least one dock electrical connector.
[0024]
[24] The endoluminal dock can include a receiving coil operatively connected to the at least one dock electrical connector and configured to wirelessly receive power from the power source.
[0025]
[25] The intraluminal extension can include a longitudinal channel configured to slidably receive the control element therein.
[0026]
[26] The intraluminal extension can include a longitudinal channel configured to circulate fluid therein for delivery to and to the exterior of the pump dock.
[0027]
[27] The intraluminal extension can include a longitudinal channel configured to receive a stiff guidewire therein to increase the stiffness of the intraluminal extension.
[0028]
[28] The intraluminal extension can include a longitudinal channel configured to communicate with the control element passage guide.
[0029]
[29] The intraluminal extension can be configured to operate to connect together at least one dock electrical connector and at least one device electrical connector.
[0030]
[30] The intraluminal extension can have a proximal end portion configured to be manipulated outside the body by an operator to connect together the at least one dock electrical connector and the at least one device electrical connector.
[0031]
[31] The intraluminal extension can be configured to be pulled to connect the at least one dock electrical connector to the at least one device electrical connector.
[0032]
[32] The intraluminal extension can be configured to be pressed to connect the at least one dock electrical connector to the at least one device electrical connector.
[0033]
[33] The at least one dock electrical connector and the at least one device electrical connector can be configured to be removably connected together, and the intraluminal extension can be further configured to be pulled to disconnect the at least one dock electrical connector from the at least one device electrical connector when connected to the at least one device electrical connector.
[0034]
[34] The at least one dock electrical connector and the at least one device electrical connector can be configured to be removably connected together, and the intraluminal extension can be further configured to be pressed to disconnect the at least one dock electrical connector from the at least one device electrical connector when connected to the at least one device electrical connector.
[0035]
[35] The endoluminal dock can be configured to dock at least partially intraluminally to an endoluminal medical device when the at least one dock electrical connector is connected to the at least one device electrical connector.
[0036]
[36] The endoluminal dock may include a pump receiving surface on its outer surface configured to at least partially mate with the endoluminal medical device when the at least one dock electrical connector is connected to the at least one device electrical connector.
[0037]
[37] The at least one dock electrical connector may define a cavity, and the system may further include a plug configured to fluid-tightly engage the cavity.
[0038]
[38] The control element may be threaded through a plug.
[0039]
[39] The endoluminal dock can include a fixture configured to secure the endoluminal modular powered medical system intraluminally.
[0040]
[40] The system may include an endoluminal dock including a plurality of dock electrical connectors, each dock electrical connector configured to receive power from a power source; and a plurality of endoluminal medical devices, each including a respective device electrical connector configured to intraluminally electrically connect to a corresponding connector of the plurality of dock electrical connectors for receiving power therefrom, wherein each connector of the plurality of device electrical connectors and each connector of the plurality of dock electrical connectors may be correspondingly configured to connect together (i) simultaneously and (ii) in a phased manner.
[0041]
[41] The intraluminal medical device may be a pump and the intraluminal dock may be a pump dock.
[0042]
[42] A second embodiment of the present disclosure is an endoluminal modular powered medical system, comprising: - an intraluminal motorized medical device including at least one control wire; an endoluminal control element guide including at least one guide hole sized and dimensioned to receive a control guide along the guide hole, the endoluminal control element guide configured to be assembled with an endoluminal powered medical device by actuation of a control wire and configured to provide power to the endoluminal powered medical device when assembled with the endoluminal powered medical device; The present invention relates to an intraluminal modular powered medical system including:
[0043]
[43] A third embodiment of the present disclosure is a method of implanting an intraluminal modular powered medical system at an intraluminal implantation site within a lumen of a subject, the method comprising: delivering an endoluminal modular powered medical system to an endoluminal implantation site, the endoluminal modular powered medical system including an endoluminal dock having a dock electrical connector and an endoluminal medical device having a device electrical connector electrically connectable to the dock electrical connector; - connecting a dock electrical connector and a device electrical connector together endoluminally to provide power to an endoluminal medical device; The present invention relates to a method comprising the steps of:
[0044]
[44] Intraluminal connecting can include manipulating a control element of the intraluminal medical device to intraluminally connect the device electrical connector and the dock electrical connector together to provide power to the intraluminal medical device.
[0045]
[45] Manipulating the control element can include slidably manipulating the control element.
[0046]
[46] Manipulating the control element can further include manipulating a proximal end portion of the control element that is located outside the body.
[0047]
[47] Intraluminal connecting may further include manipulating an intraluminal extension of the intraluminal dock to intraluminally connect the dock electrical connector and the device electrical connector together to provide power to the intraluminal medical device.
[0048]
[48] Manipulating the intraluminal extension can include slidably manipulating the intraluminal extension.
[0049]
[49] Manipulating the intraluminal extension can further include manipulating a proximal end portion of the intraluminal extension located outside the body.
[0050]
[50] The method may further include powering the endoluminal medical device via the endoluminal dock by at least one of: i) electrically connecting the endoluminal dock to a power source; and (ii) wirelessly transferring energy between the endoluminal dock and the power source.
[0051]
[51] Delivering the endoluminal modular powered medical system can include obtaining an endoluminal access opening for delivering the endoluminal modular powered medical system to an endoluminal implantation site.
[0052]
[52] Delivering the endoluminal modular powered medical system may further include introducing a sheath at least partially housing the endoluminal modular powered medical system therein into the lumen through the endoluminal access opening, advancing the sheath intraluminally through the lumen to an intraluminal implantation site of the endoluminal modular powered medical system, and expelling the modular endoluminal medical device assembly from the sheath at the intraluminal implantation site of the endoluminal modular powered medical system within the lumen.
[0053]
[53] The method may further include securing the endoluminal modular powered medical system at the endoluminal implantation site.
[0054]
[54] Delivering the endoluminal modular powered medical system can further include removing the sheath from the lumen after the endoluminal modular powered medical system is ejected from the sheath at the endoluminal implantation site.
[0055]
[55] Delivering the endoluminal modular powered medical system can further include surgically closing the endoluminal access opening.
[0056]
[56] The intraluminal medical device can be an intraluminal medical device and the intraluminal dock can be an intraluminal dock.
[0057]
[57] A fourth embodiment of the present disclosure is a method of extracting an intraluminal modular powered medical system from an intraluminal implantation site within a lumen of a subject, the intraluminal modular powered medical system including an intraluminal dock having a dock electrical connector and an intraluminal medical device having a device electrical connector electrically disconnectable from the dock electrical connector; - intraluminally disconnecting the dock electrical connector and the device electrical connector from each other to stop power supply to the intraluminal medical device; -retrieving the endoluminal modular powered medical system from the endoluminal implantation site; The present invention relates to a method comprising the steps of:
[0058]
[58] Endoluminal decoupling can include manipulating a control element of the endoluminal medical device to endoluminally decouple the device electrical connector and the dock electrical connector from one another to discontinue power supply to the endoluminal medical device.
[0059]
[59] Manipulating the control element can include slidably manipulating the control element.
[0060]
[60] Manipulating the control element can further include manipulating a proximal end portion of the control element that is located outside the body.
[0061]
[61] Intraluminal decoupling may further include manipulating an intraluminal extension of the intraluminal dock to intraluminally decouple the dock electrical connector and the device electrical connector from one another to discontinue power supply to the intraluminal medical device.
[0062]
[62] Manipulating the intraluminal extension can include slidably manipulating the intraluminal extension.
[0063]
[63] Manipulating the intraluminal extension can further include manipulating a proximal end portion of the intraluminal extension located outside the body.
[0064]
[64] The method may further include interrupting the supply of power to the endoluminal medical device by at least one of: i) electrically disconnecting the endoluminal dock from the power source; and (ii) interrupting the wireless transfer of energy between the endoluminal dock and the power source.
[0065]
[65] Retrieving the endoluminal modular powered medical system can include obtaining an endoluminal access opening for retrieving the endoluminal modular powered medical system from the endoluminal implantation site.
[0066]
[66] Retrieving the endoluminal modular powered medical system may further include introducing a sheath into the lumen through the endoluminal access opening, advancing the sheath intraluminally through the lumen to an intraluminal implantation site of the endoluminal modular powered medical system, and at least partially lifting the endoluminal modular medical device system within the sheath out of the lumen at the intraluminal implantation site of the endoluminal modular powered medical system.
[0067]
[67] The method may further include unlocking the endoluminal modular powered medical system from the endoluminal implantation site.
[0068]
[68] Retrieving the endoluminal modular powered medical system may further include removing a sheath at least partially housing the endoluminal modular powered medical system therein from the lumen.
[0069]
[69] Retrieving the endoluminal modular powered medical system can further include surgically closing the endoluminal access opening.
[0070]
[70] The intraluminal medical device can be a pump and the intraluminal dock can be an intraluminal dock.
[0071] definition
[71] As intended herein:
[0072]
[72] The terms "proximal" and "proximally" refer to a location or position closer to an operator of an intraluminal modular powered medical system described herein as compared to a location or position that is distal, or positioned distally, or located distally to the same operator.
[0073]
[73] The terms "distal" and "distally" refer to a location or position that is proximal, or positioned proximally, or located proximally relative to an operator of an intraluminal modular powered medical system described herein.
[0074]
[74] The terms “comprising,” “having,” “including,” and “containing” are to be construed as open-ended terms. [Brief description of the drawings]
[0075] BRIEF DESCRIPTION OF THE DRAWINGS [Figure 1A]
[75] FIG. 1 is a schematic diagram of a pump dock of a modular pump system, according to one embodiment. [Figure 1B] FIG. 1B is a schematic diagram of a first pump and a second pump of a modular pump system, both of which are dockable to the pump dock of FIG. 1A. [Figure 1C]
[77] FIG. 1C is a schematic diagram of a modular pump system, in which both the first and second pumps of FIG. 1B are docked to the pump dock of FIG. 1A. [Figure 2A]
[78] FIG. 11 is a flowchart illustrating a sequence of operations for implanting a modular pump system, according to one embodiment. [Figure 2B]
[79] FIG. 11 is a flowchart illustrating a sequence of operations for extracting a modular pump system, according to one embodiment. [Figure 3A]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 3B]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 3C]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 3D]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 4A]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 4B]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 4C]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 4D]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 5A]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 5B]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 5C]
[80] Figure 8 illustrates a modular pump system having multiple pumps, each pump having its own prong electrical connector, according to one embodiment. [Figure 6A]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 6B]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 6C]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 6D]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 6E]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 7A]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 7B]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 7C]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 7D]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 8A]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 8B]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 8C]
[81] FIG. 1 illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and a respective fluid seal, according to one embodiment. [Figure 9A]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 9B]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 9C]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 9D]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 9E]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 10A]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 10B]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 10C]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 10D]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 11A]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 11B]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 11C]
[82] illustrates a modular pump system including multiple pumps, each having a respective prong electrical connector and two respective fluid seals, according to one embodiment. [Figure 12A]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 12B]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 12C]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 12D]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 13A]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 13B]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 13C]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 13D]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 14A]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 14B]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 14C]
[83] FIG. 1 illustrates a modular pump system including multiple pumps, each pump having a plurality of respective prong connectors, according to one embodiment. [Figure 15A]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 15B]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 15C]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 15D]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 16A]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 16B]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 16C]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 16D]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 17A]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 17B]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 17C]
[84] illustrates a modular pump system including multiple pumps, each having a respective prong connector having protruding conductive sections circumferentially distributed about its periphery, according to one embodiment. [Figure 18A]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 18B]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 18C]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 18D]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 19A]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 19B]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 19C]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 19D]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 20A]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 20B]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 20C]
[85] An embodiment of a modular pump system including a plurality of pumps and a plurality of control elements is shown, each control element being removably attachable to a corresponding pump. [Figure 21A]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 21B]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 21C]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 21D]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 22A]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 22B]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 22C]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 23A]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 23B]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 23C]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 23D]
[86] An embodiment of a modular pump system including a plurality of pumps, a plurality of control elements, and a plurality of catheters, each catheter being attached to a corresponding pump and defining a lumen housing a corresponding control element removably attachable to the corresponding pump. [Figure 24A]
[87] FIG. 1 illustrates a modular pump system configured to fluidly couple to a fluid flush device, according to one embodiment. [Figure 24B]
[87] FIG. 1 illustrates a modular pump system configured to fluidly couple to a fluid flush device, according to one embodiment. [Figure 24C]
[87] FIG. 1 illustrates a modular pump system configured to fluidly couple to a fluid flush device, according to one embodiment. [Figure 25A]
[87] FIG. 1 illustrates a modular pump system configured to fluidly couple to a fluid flush device, according to one embodiment. [Figure 25B]
[87] FIG. 1 illustrates a modular pump system configured to fluidly couple to a fluid flush device, according to one embodiment. [Figure 25C]
[87] FIG. 1 illustrates a modular pump system configured to fluidly couple to a fluid flush device, according to one embodiment. [Figure 25D]
[87] FIG. 1 illustrates a modular pump system configured to fluidly couple to a fluid flush device, according to one embodiment. [Figure 26A]
[88] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 26B]
[88] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 26C]
[88] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 26D]
[88] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 27A]
[89] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 27B]
[89] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 27C]
[89] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 27D]
[89] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 28A]
[89] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 28B]
[89] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 28C]
[89] An illustration of a modular pump system having a coil configured to receive power wirelessly, according to one embodiment. [Figure 29A]
[90] illustrates a modular pump system including multiple pumps, each pump configured to be pushed to connect and dock the pump to a pump dock, according to one embodiment. [Figure 29B]
[90] illustrates a modular pump system including multiple pumps, each pump configured to be pushed to connect and dock the pump to a pump dock, according to one embodiment. [Figure 29C]
[90] illustrates a modular pump system including multiple pumps, each pump configured to be pushed to connect and dock the pump to a pump dock, according to one embodiment. [Figure 29D]
[90] illustrates a modular pump system including multiple pumps, each pump configured to be pushed to connect and dock the pump to a pump dock, according to one embodiment. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS
[0076] Detailed Description
[91] The modular pump systems of the present disclosure are assembleable and operable in vivo. As described below, each of the modular pump systems can be delivered transcatheterically and / or percutaneously to an intraluminal site in an unassembled, undocked configuration for implantation in a subject's vasculature. Each of the modular pump systems can then be converted from the unassembled, undocked configuration to an assembled, docked configuration, and each can be provided with power for operation of the pumps. Each of the modular pump systems can also be retrieved transcatheterically and / or percutaneously from an intraluminal site for removal from the subject's vasculature after they have been converted from their assembled, docked configuration to the unassembled, undocked configuration and the pumps are no longer provided with power. In the unassembled, undocked configuration, the pumps are generally arranged in series or one after the other, whereas in the assembled, docked configuration, the pumps are generally arranged in parallel or side-by-side. Intraluminal sites of implantation include any lumen of the body, such as the vascular system, hollow viscera and body cavities, including the chambers of the heart.
[0077]
[92] Figures 1A-1C are schematic diagrams of a modular pump system 100 (also referred to herein as an intraluminal modular powered medical system) and its components. In Figures 1A-1C, solid lines indicate elements of the modular pump system 100 and dotted lines indicate optional elements of the modular pump system 100. More specifically, Figure 1A illustrates a schematic diagram of a pump dock 110 (also referred to herein as an intraluminal dock or an intraluminal control element guide) according to one embodiment. Figure 1B illustrates a schematic diagram of a first pump 130 and a second pump 140 (also referred to herein as a first and second intraluminal medical device or a first and second intraluminal powered medical device) according to one embodiment. Figure 1C illustrates a schematic diagram of a first pump 130 and a second pump 140 docked (i.e., in a docked configuration) to a pump dock 110 according to one embodiment. While Figures 1A-1C relate to modular pump system 100 and its components, it will be understood that Figures 1A-1C also apply to modular pump systems 300, 400, 500, 600, 700, 800, 900, 1000, 1100, 1200, and 1300 and their respective components, as described herein, with necessary mutatis mutandis, where applicable, as would be recognized by one of ordinary skill in the art.
[0078]
[93] The pump dock 110 provides a structure to which at least one pump can be docked and electrically connected to be powered and operated. The pump can be removably dockable (i.e., undockable) and removably electrically connectable (i.e., electrically disconnectable) to the pump dock 110. FIG. 1A illustrates the pump dock 110 including a first dock electrical connector 112a and a second dock electrical connector 112b, and FIG. 1C illustrates the pump dock 110 including a first dock electrical connector 112a and a second dock electrical connector 112b electrically connected to a first pump 130 and a second pump 140, respectively. More specifically, the first dock electrical connector 112a is mechanically and electrically connected to the first pump 130 via a first pump electrical connector 133 (also referred to herein as a device electrical connector, described below), thereby configured to dock the first pump 130 to the pump dock 110. Similarly, the second dock electrical connector 112b is mechanically and electrically connected to the second pump 140 via the second pump electrical connector 143 (also referred to herein as a device electrical connector, described below), thereby configured to dock the second pump 140 to the pump dock 110. The first dock electrical connector 112a and the second dock electrical connector 112b may be electrically disconnectable from the first pump electrical connector 133 and the second pump electrical connector 143, respectively, thereby allowing the first pump 130 and the second pump 140, respectively, to be undockable from the pump dock 110.
[0079]
[94] Thus, the first dock electrical connector 112a and the second dock electrical connector 112b can be configured not only to supply electricity to the corresponding first pump electrical connector 133 and second pump electrical connector 143 when connected thereto, but also to dock the pump dock 110 to the first pump 130 and second pump 140.
[0080]
[95] The pump dock 110 may include two or more dock electrical connectors for each pump connectable to it.
[0081]
[96] The pump dock 110 may include at least one dock physical connector (not shown in FIGS. 1A and 1C) for each pump connectable thereto. The dock physical connector, which does not provide electricity to the pump, may be configured to (i) activate and / or maintain a physical docking interaction between the pump dock 110 and the pump in combination with the dock electrical connector (i.e., the physical connection components of the docking interaction between the pump dock 110 and the pump are shared by the dock physical connector and the dock electrical connector), or (ii) activate and / or maintain a physical docking interaction between the pump dock 110 and the pump without the assistance of the dock electrical connector (i.e., the physical connection components and the electrical connection components of the docking interaction between the pump dock 110 and the pump are separated between the dock physical connector and the dock electrical connector, respectively). For example, the pump dock 110 may include one dock electrical connector and one dock physical connector.
[0082]
[97] The pump dock 110 includes at least one control element passage guide (also referred to herein as a guide hole) defined along or through the pump dock 110 and sized and shaped to receive at least one corresponding control element, such as the first wire control element 134 of the first pump 130 or the second control element 144 of the second pump 140 (shown in FIG. 1B ). Once so received, the control element can be actuated to slidably move along the control element passage guide, resulting in movement of the corresponding pump relative to the pump dock 110. For example, the pump dock 110 can include first and second control element passage guides (not shown), each sized and shaped to receive the corresponding first wire control element 134 and second control element 144 of the first pump 130 and second pump 140 respectively therealong. Actuation of the first wire control element 134 and the second control element 144 along the first and second control element passage guides, respectively, allows the first pump 130 and the second pump 140, respectively, to be slidably movable relative to the pump dock 110.
[0083]
[98] The pump dock 110 may include multiple control element passageway guides, each of which is sized and shaped to receive a corresponding one of the control elements of one of the multiple pumps. Alternatively, the pump dock 110 may include only one control element passageway guide that is sized and shaped to receive all of the corresponding control elements of the multiple respective pumps.
[0084]
[99] The pump dock 110 may optionally include at least one pump receiving surface, such as on its exterior surface, that is sized and shaped to mate with a corresponding pump. The pump receiving surface and the pump may be complementary in size and / or shape to structurally match one another when mated together. The pump receiving surface may at least help to guide, actuate, and / or maintain a docking interaction between the pump dock 110 and a pump that is to be docked or has already been docked to the pump dock 110. The mating between the pump receiving surface and the pump may be a removable mating.
[0085]
[0100] As the pump and pump dock 110 move closer to one another, such as by sliding the pump towards the pump dock 110, the pump gradually engages and / or contacts the corresponding pump receiving surface. As the pump advances along the pump receiving surface, the pump electrical connector gradually engages with the dock electrical connector, eventually establishing an electrical connection with the dock electrical connector.
[0086]
[0101] As shown in Figures 1A and 1C, the pump dock 110 can include a first pump receiving surface 111a associated with or integral with a first dock electrical connector 112a and a second pump receiving surface 111b associated with or integral with a second dock electrical connector 112b. For example, as further shown in the embodiments of Figures 3A, 4A, 5A, 6A, 7A, 8A, 9A, 10A, 11A, 12A, 13A, 14A, 15A, 16A, 17A, 18A, 19A, 20A, 21A, 22A, 23C, 24A, 25A, the pump receiving surfaces 111a, 111b are at least partially formed by protrusions that protrude distally from the pump dock (i.e., in a direction opposite a power connector, described below, extending from the pump dock). As such, the first dock electrical connector 112a and the second dock electrical connector 112b are associated with or integral with the pump receiving surfaces 111a, 111b, respectively. The first dock electrical connector 112a and the second dock electrical connector 112b define respective cavities that generally extend in a proximal direction opposite the distal direction of the projections.
[0087]
[0102] When multiple pumps are connectable to the pump dock 110, the protrusions can be positioned and arranged on the pump dock 110 to define one or more pump receiving surfaces that are sized and shaped to mate with only a portion of the multiple corresponding pumps, while the remaining pumps are connected to the pump dock 110 without mating with any of the pump receiving surfaces.
[0088]
[0103] The pump receiving surface(s) may be associated with or integral with one or more dock electrical connectors and / or one or more dock physical connectors. If the electrical connectors and / or dock physical connectors are not associated with or integral with a pump receiving surface, they may be located elsewhere on the pump dock 110.
[0089]
[0104] As shown in Figures 1A and 1C, the pump dock 110 may further include at least one power connector 113 (also referred to herein as an intraluminal extension) protruding from the pump dock 110, and when the modular pump system 100 is delivered or implanted, the power connector 113 may extend intraluminally, such as through the vascular system, and connect to a power source (not shown).
[0090]
[0105] The power connector 113 is connected at its distal end portion to the first dock electrical connector 112a and the second dock electrical connector 112b and is configured to provide electrical power thereto when connected to the pump dock 110, and thus to provide electrical power to the first pump 130 and the second pump 140, respectively. As such, the power connector may include an electrical conductor, an electrical cable, or a wire. The proximal end portion of the power connector 113 may be positioned intraluminally (e.g., within the vascular system), extraluminally (e.g., outside the vascular system but still within the subject's body), and extracorporeally. The proximal end portion of the power connector 113 is operable intraluminally or extracorporeally by an operator to move the pump dock 110 intraluminally to dock and connect to the first pump 130 and the second pump 140, and to undock and disconnect the pump dock 110 from the first pump 130 and the second pump 140.
[0091]
[0106] A proximal end portion of the power connector 113 is operatively connectable or removably operatively connectable to a power source via a wired electrical connection or wireless power transmission. In the case of a wired electrical connection, the power connector 113 is operatively connectable to a power source intraluminally (e.g., within the vascular system), extraluminally (e.g., outside the vascular system but within the subject's body), and extracorporeally. In the case of wireless power transmission, the power connector 113 is electrically connected to a receiving coil (not shown) configured to receive power from a transmitting coil (not shown) of the power source.
[0092]
[0107] Alternatively, the power connector 113 may itself be a receiving coil in the shape of a coil, spiral, helix, etc., that is coupled to the pump dock 110 at any suitable location, such as at the fixture 115, and configured to receive power from a transmitting coil of the power source. Wireless power transmission may include near-field inductive power transmission (e.g., when used, the transmitting coil and receiving coil are located inside or outside the body) or transcutaneous near-field inductive energy transmission (e.g., when used, the transmitting coil is located outside the body and the receiving coil is located inside the body).
[0093]
[0108] Further alternatively or additionally, the pump dock 110, which may be configured to receive power from a power source either wired or wirelessly, includes a transmitting coil and the pump includes a receiving coil configured to wirelessly receive power from the transmitting coil of the pump dock 110.
[0094]
[0109] The pump dock 110 may also include a battery, such as a rechargeable battery, configured to receive power from a power source and power at least one of the pumps 130, 140.
[0095]
[0110] Advantageously, the wireless transmission of power from outside the body to the modular pump system 100 allows for an improved design that does not require power cables or wires to extend from the pump dock 110 through and / or to the subject's body to power and / or control the modular pump system 100, thereby at least reducing the risks associated with infection, congestion, and other related complications.
[0096]
[0111] The power source may include any type of suitable power source known in the art, including one or more batteries, a power grid, or any other suitable energy supply and / or energy storage, and combinations thereof. The power source may be configured to provide power to the pump dock in a wired and / or wireless manner.
[0097]
[0112] 1A and 1C, the pump dock 110 can further include at least one wire control component 114 (also referred to herein as an intraluminal extension) that extends from the pump dock 110 such that the wire control component 114 can extend intraluminally, such as through the vasculature, when the modular pump system 100 is delivered or implanted. In this manner, a proximal end portion of the wire control component 114 can be positioned intraluminally (e.g., within the vasculature), extraluminally (e.g., outside the vasculature but still within the subject's body), and extraluminally.
[0098]
[0113] The wire control component 114 may be a guidewire or any other suitable wire, cable, or the like (in which case it is also referred to herein as a wire control component), which is operable at its proximal end portion by an operator, either intraluminally or extracorporeally, to dock and connect the pump dock 110 to the first pump 130 and the second pump 140, and to undock and disconnect the pump dock 110 from the first pump 130 and the second pump 140. In this manner, the wire control component 114 may be detachable from the pump dock 110 by manipulation by an operator. For example, the wire control component may be threadably engageable with the pump dock 110, such that an operator can rotate the wire control component to thread the wire control component to and unthread the wire control component from the pump dock 110. The wire control component 114 may also be a snare configured to capture and / or release the pump dock 110. Once attached, the wire-over-wire control component 114 can be used to pull and / or push the modular pump system including the pump dock 110.
[0099]
[0114] The wire control component 114 may also be a catheter (in which case also referred to herein as a catheter control component) configured to carry components and / or fluids to the pump dock 110 and thus, optionally, deliver the components and / or fluids intraluminally. For example, a relatively stiff guidewire (also referred to herein as a stiff guidewire) may be threaded through the catheter control component to provide the catheter control component with structural stiffness and / or tactile feedback for improved intraluminal navigation of the pump dock 110 (docked to or undocked from the pump), such as within the vasculature. For example, such adjustable improved structural stiffness and / or stiffness of the catheter control component may be useful when the pump dock 110 needs to be pushed by an operator toward the first and second pumps 130 and 140, such as for docking and / or undocking purposes. In fact, the improved structural rigidity and / or stiffness provided to the catheter control components by the stiff guidewire allows the catheter control components to better transmit pushing forces to the pump dock 110, rather than being improperly bent or folded by the pushing forces and impeding or preventing the operator's intended operation.
[0100]
[0115] By selecting wires of varying stiffness and / or by at least partially inserting and removing such wires within the catheter control component, the structural rigidity and / or stiffness of the catheter control component can be adjusted, thus further improving the intraluminal navigation and tactile feedback of the pump dock 110.
[0101]
[0116] The catheter control components can also be used with a fluid flush device (not shown) to provide a flush solution (e.g., a glucose flush) to the pump dock 110. For example, the fluid flush device can provide fluid from the pump dock 110 via a fluid connector that can be structurally integrated into the first pump electrical connector 133 and / or 143 to the pump at high pressure (e.g., at a pressure higher than the intraluminal or intraluminal pressure in which the device is implanted, such as greater than 140 mmHg in the arterial circulation) to prevent blood from entering the motor of the first pump 130 and / or 140. The fluid flush device can also provide fluid in a closed circuit to the pump 130 and / or 140 (e.g., if the motor is not an electric motor) to hydraulically entrain the rotation of the pump's impeller.
[0102]
[0117] 1A and 1C, the pump dock 110 may further include at least one catheter 116 (also referred to herein as an intraluminal extension) that protrudes from the pump dock 110 such that the catheter 116 may extend intraluminally, such as through the vasculature, when the modular pump system 100 is delivered or implanted. In this manner, the proximal end portion of the catheter 116 may be positioned intraluminally (e.g., within the vasculature), extraluminally (e.g., outside the vasculature but still within the subject's body), and extracorporeally. The proximal end portion of the catheter 116 may be manipulated intraluminally or extracorporeally by an operator to move the pump dock 110 intraluminally to dock and connect to the first pump 130 and the second pump 140, and to undock and disconnect the pump dock 110 from the first pump 130 and the second pump 140.
[0103]
[0118] The catheter 116 defines at least one longitudinal channel (also referred to herein as a lumen, not shown) along at least a portion thereof. The catheter 116 is sized and shaped to receive therein the power connector 113, the wire control component 114, and / or the first wire control element 134 and the second control element 144 (collectively referred to herein as intraluminal extensions). All of the intraluminal extensions may be received in a single longitudinal channel. Alternatively, the intraluminal extensions or combinations thereof may be received in respective longitudinal channels. For example, the catheter 116 may define two longitudinal channels, each configured to receive one of the first wire control element 134 and the second control element 144 therein. The longitudinal channels may be sized and / or shaped in any suitable manner. For example, the cross-sectional size of the longitudinal channel may be sized slightly larger than the cross-sectional size of a given control element to allow sufficient translation of the control element therethrough while limiting any free space in which the control element may buckle, twist, etc.
[0104]
[0119] As shown in FIGS. 1A and 1C , the pump dock 110 may further include a fixture 115 configured to secure the pump dock 110 (and the modular pump system 100 when the first pump 130 and the second pump 140 are docked to the pump dock 110) within a lumen, such as at an intraluminal implantation site within the aorta or a chamber of the heart. For example, the fixture may apply a force to the pump dock 110 to secure the pump dock 110 to a wall of the vasculature. The pump dock 110 has a compact configuration for intraluminal delivery, such as via a transcatheter procedure, and an expanded configuration for securing the pump dock 110 within a lumen. The cross-sectional size of the fixture in the compact configuration is smaller than the cross-sectional size of the fixture 115 in the expanded configuration.
[0105]
[0120] The fastener 115 may be self-expanding (e.g., made from a shape memory material such as Nitinol) such that the fastener changes on its own (e.g., by being expelled from a sheath or sheath) from the compact configuration to the expanded configuration at the intraluminal implantation site. If self-expanding, the fastener 115 may be biased or overcomeably biased toward the expanded configuration. For example, the fastener may be like the fastener assembly described in International Patent Application PCT / ZA2020 / 050,022, which is incorporated by reference in its entirety for all purposes as if fully set forth herein, including all of the references incorporated by reference therein, except for any definitions, disclaimers or disclaimers of subject matter, and except to the extent the incorporated content is inconsistent with the express disclosure of this specification, in which case the language of the present disclosure will control.
[0106]
[0121] Alternatively, the anchor 115 may also be mechanically expandable. For example, a balloon catheter disposed within the anchor 115 may be inflated to partially or completely transform the anchor 115 from a compact configuration to an expanded configuration (in which case the anchor 115 is made of a "non-shape memory" material).
[0107]
[0122] Further alternatively, the anchor 115 may be operably coupled to a anchor actuation stem (not shown) configured to be manipulated by an operator to convert or effect conversion of the anchor 115 from the compact configuration to the expanded configuration (in which case the anchor 115 may be made of a shape memory material that biases the anchor 115 toward the expanded configuration) and / or from the expanded configuration to the compact configuration.
[0108]
[0123] As described for the intraluminal device and luminal wall anchor assembly of a mammalian body conduit described in International Patent Application PCT / US2021 / 012,083, the anchor 115 can be releasably coupled to the pump dock 110 and thus releasable from the pump dock 110 upon actuation of the actuation rod or wire. The STEAM application, including all of the references incorporated by reference therein, is incorporated by reference in its entirety for all purposes as if fully set forth herein, except for any definitions, disclaimers or disclaimers of subject matter, and except to the extent the incorporated content is inconsistent with the express disclosure of this specification, in which case the language of the present disclosure will control.
[0109]
[0124] 1B, the modular pump system 100 includes at least one pump (also referred to herein as an intraluminal medical device and an intraluminal powered medical device), such as a first pump 130 and a second pump 140. Because the first pump 130 (and its components, if applicable) is similar to the second pump 140 (and its components, if applicable), only the first pump 130 (and its components, if applicable) will be described below. Those skilled in the art will understand that the description of the first pump 130 (and its components, if applicable) also applies to the second pump 140 (and its components, if applicable), mutatis mutandis, if applicable, as recognized by those skilled in the art.
[0110]
[0125] The first pump 130 includes a first impeller 131 for moving fluid within the lumen, a first motor 132 operably connected to the first impeller 131 directly or indirectly (e.g., via a gearbox) to rotate the first impeller 131, a first pump electrical connector 133 (also referred to herein as a first device electrical connector) operably connected to the first motor 132 to supply power to the first motor 132 and operably connectable or removably connectable to the first dock electrical connector 112a to receive power from the first dock electrical connector 112a, and a first wire control element 134 (also referred to herein as an intraluminal extension) attached to and protruding from the first pump 130 to move the first pump 130 within the lumen. The first pump 130 is configured to be delivered intraluminally from the pump dock 110 in an undocked state (i.e., in an unassembled, undocked form) and to be intraluminally docked to the pump dock 110 (i.e., in an assembled, docked form), such as within the subject's vasculature.
[0111]
[0126] The first impeller 131 may be an axial impeller, a peripheral impeller, a mixed flow impeller or a radial impeller. Preferably, the first impeller is an axial impeller of an axial pump.
[0112]
[0127] The first motor 132 may be an electric motor, such as a brushless electric motor.
[0113]
[0128] 1B, the first pump 130 can include at least one control element (also referred to herein as an intraluminal extension), such as a first wire control element 134. The first wire control element 134 can be connected anywhere on the first pump 130 and can extend therefrom. For example, the first wire control element 134 can be connected to and can extend therefrom a first pump electrical connector 133 of the first pump 130. Alternatively, the first wire control element 134 can be connected to and can extend therefrom a corresponding pump physical connector (not shown, described below). The first wire control element 134 extends from the first pump 130 such that when the modular pump system 100 is delivered or implanted, the first wire control element 134 can extend intraluminally, such as through the vasculature. In this manner, the proximal end portion of the first wire controlling element 134 can be positioned intraluminally (e.g., within the vascular system), extraluminally (e.g., outside the vascular system but still within the subject's body), and extracorporeally.
[0114]
[0129] A first wire control element 134 protruding from the first pump 130 and slidably received within a corresponding control element passage guide of the pump dock 110 is operable at its proximal end portion by an operator to dock the first pump 130 to the pump dock 110 and to undock the first pump 130 from the pump dock 110.
[0115]
[0130] More specifically, with the first pump 130 positioned distally relative to the pump dock 110, the proximal end portion of the first wire control element 134 can be pulled away relative to the pump dock 110 to dock the first pump 130 to the pump dock 110 and connect the first pump electrical connector 133 to the first dock electrical connector 112a. Conversely, the proximal end portion of the first wire control element 134 can be pushed toward the pump dock 110 to undock the first pump 130 from the pump dock 110 and disconnect the first pump electrical connector 133 from the first dock electrical connector 112a.
[0116]
[0131] Alternatively, with the first pump 130 positioned proximally relative to the pump dock 110, a proximal end portion of the first wire control element 134 can be pushed toward the pump dock 110 to dock the first pump 130 to the pump dock 110 and connect the first pump electrical connector 133 to the first dock electrical connector 112a. Conversely, a proximal end portion of the first wire control element 134 can be pulled toward the pump dock 110 to undock the first pump 130 from the pump dock 110 and disconnect the first pump electrical connector 133 from the first dock electrical connector 112a.
[0117]
[0132] When the modular pump system 100 is delivered and implanted in vivo, if the pump dock 110 is located within a lumen, such as within the subject's vascular system, docking and connection of the first pump 130 to the pump dock 110 and undocking and disconnection of the first pump 130 from the pump dock 110 can be performed within the lumen, with the first wire control element 134 extending from the pump dock along this lumen to position its proximal end portion at an extraluminal or extracorporeal location to be manipulated by an operator.
[0118]
[0133] The first wire control element 134 may be a guidewire or any other suitable wire, cable, etc. (in which case, also referred to herein as a first wire control element and a wire control element), which is configured to be manipulable at its proximal end portion by an operator. Manipulation of the first wire control element 134 moves the corresponding first pump 130 relative to the pump dock 110 to dock and electrically connect the first pump 130 to the pump dock 110 for operation, and to undock and electrically disconnect the first pump 130 from the pump dock 110. The first wire control element 134 may be attachable or removably attachable to the first pump 130 and detachable or removably detachable from the first pump 130, by manipulation by the operator. For example, the first wire control element 134 may be threadably engageable with the first pump 130 such that an operator can rotate the first wire control element 134 to thread the first wire control element 134 onto and unthread the first wire control element 134 from the first pump 130. The first wire control element 134 may also be a snare configured to capture and / or release the first pump 130. When attached, the first wire control element 134 may be used to pull and / or push the modular pump system 100 including the first pump 130.
[0119]
[0134] Because the first pump 130 receives power via the pump dock 110 when electrically connected to the pump dock 110, the first wire control element 134 need not be configured to conduct electricity to power the first pump 130, as is the case, for example, with the modular mammalian body-implantable fluid flow affecting device described in International Patent Application No. PCT / ZA2020 / 050,022, which is incorporated by reference in its entirety for all purposes as if fully set forth herein, including all of the references incorporated by reference therein, except for any definitions, disclaimers or disclaimers of subject matter, and except to the extent the incorporated content is inconsistent with the express disclosure of this specification, in which case the language of the present disclosure will control.
[0120]
[0135] Considering that it is not configured to conduct electricity, the first wire control element 134 has a smaller cross-sectional size than if it were required to conduct electricity, for example by incorporating an electrically conductive material. Advantageously, this reduced cross-sectional size allows the first wire control element 134 to have a reduced intraluminal cross-sectional footprint when threaded through the vasculature, thus reducing blood flow obstructions. The reduced cross-sectional size and intraluminal cross-sectional footprint of the control element is also advantageous when the implanted modular pump system 100 includes multiple pumps, each having a respective control element extending therefrom within a lumen of the vasculature. In this case, multiple control elements may collectively cause blood flow obstructions, and powering the pumps through a pump dock allows the overall intraluminal cross-sectional footprint of the control elements and associated blood flow obstructions therefrom to be reduced.
[0121]
[0136] The first wire control element 134 may also be a catheter (in which case also referred to herein as a first catheter control element and catheter control element) configured to carry components and / or fluids to the first pump 130 and thus optionally deliver the components and / or fluids intraluminally. For example, a relatively stiff guidewire (also referred to herein as a stiff guidewire) may be threaded through the first catheter control element to provide the first catheter control element with structural stiffness and / or tactile feedback for improved intraluminal navigation of the first pump 130 (docked to or undocked from the pump dock 110), such as within the vasculature. For example, such adjustable improved structural stiffness and / or stiffness of the first catheter control element may be useful when the first pump 130 needs to be pushed by an operator towards the pump dock 110, such as for docking and / or undocking purposes. In fact, the improved structural rigidity and / or stiffness provided to the first catheter control element by the stiff guidewire allows the first catheter control element to better transmit pushing forces to the pump dock 110, rather than being improperly bent or folded by the pushing forces and impeding or preventing the operator's intended operation.
[0122]
[0137] By selecting wires of different stiffness and / or by at least partially inserting and removing such wires within the first catheter control element, the structural rigidity and / or stiffness of the first catheter control element can be adjusted, thus further improving the intraluminal navigation and tactile feedback of the first pump 130.
[0123]
[0138] The first catheter control element may also be used with a fluid flush device (not shown) that provides a flush solution (e.g., a glucose flush) to the first pump 130. For example, the fluid flush device may provide fluid to the first pump 130 at high pressure (e.g., at a pressure higher than the intraluminal or intraluminal pressure in which the device is implanted, such as greater than 140 mmHg in the arterial circulation) to prevent blood from entering the first motor 132. The fluid flush device may also provide fluid in a closed circuit to the first pump 130 (e.g., if the motor is not an electric motor) to hydraulically entrain the rotation of the first impeller 131.
[0124]
[0139] 1B, the first pump 130 can include at least one pump electrical connector (also referred to herein as a first device electrical connector and a device electrical connector), such as a first pump electrical connector 133. The first pump electrical connector 133 is configured to removably or non-removably electrically connect to a corresponding first dock electrical connector 112a in such a manner that the first pump electrical connector 133 can terminate within, around, and / or adjacent to the first dock electrical connector 112a. When the first pump 130 is properly docked to the pump dock 110, the first dock electrical connector 112a provides electrical power to the first pump electrical connector to rotate the first impeller 131 of the first pump 130.
[0125]
[0140] Thus, the first pump electrical connector 133 can be configured not only to receive electricity therefrom when connected to the corresponding first dock electrical connector 112a, but also to dock the first pump 130 to the pump dock 110.
[0126]
[0141] The first pump 130 may include multiple pump electrical connectors, such as two or three pump connectors, each of which is configured to operate at a different phase.
[0127]
[0142] The first pump 130 may include at least one pump physical connector (not shown in FIG. 1B). The pump physical connector, which does not receive electricity from the pump dock 110, is configured to cooperatively connect, either removably or non-removably, to a corresponding dock physical connector of the pump dock 110. Similar to the dock physical connector, the pump physical connector may be configured to (i) activate and / or maintain a physical docking interaction between the pump and the pump dock 110 in combination with the pump electrical connector (i.e., the physical connection components of the docking interaction between the pump and the pump dock 110 are shared by the pump physical connector and the pump electrical connector), or (ii) activate and / or maintain a physical docking interaction between the pump and the pump dock 110 without the assistance of the pump electrical connector (i.e., the physical connection components and the electrical connection components of the docking interaction between the pump and the pump dock 110 are separated between the pump physical connector and the pump electrical connector, respectively). For example, the first pump 130 may include one pump electrical connector and one pump physical connector.
[0128]
[0143] The first pump 130 may include one or more pump electrical connectors and / or one or more pump physical connectors. For example, the first pump 130 may include at least one first pump electrical connector 133 configured for both electrical powering of the first pump 130 via the pump dock 110 and physical docking of the first pump 130 to the pump dock 110. Alternatively, the first pump 130 may also include at least one first pump electrical connector 133 configured for electrical powering of the first pump 130 via the pump dock 110 and at least one pump physical connector configured for physical docking of the first pump 130 to the pump dock 110.
[0129]
[0144] When one or more pump electrical connectors and / or one or more pump physical connectors are provided on the first pump 130, a corresponding number of dock electrical connectors and / or dock physical connectors, including a corresponding number of optional pump receiving surfaces, are provided on the pump dock 110.
[0130]
[0145] The pump dock 110 and the first pump 130 are dockable together and connectable together to provide power for operation to the first pump 130. More specifically, the pump dock 110 and the first pump 130 are dockable together and connectable together via (i) a cooperative interengagement between the first dock electrical connector 112a and the first pump electrical connector 133, (ii) an optional cooperative interengagement between the dock physical connector and the first pump physical connector, and (iii) an optional cooperative interengagement fit between the pump receiving surface 111a and the first pump 130, such as at its outer surface.
[0131]
[0146] Such cooperative interengagement enables (i) a docking interaction between the pump dock 110 and the first pump 130 that is strong enough to reduce undesirable undocking and / or undesirable detachment of the first pump 130 from the pump dock 110 at least during operation, and (ii) providing proper orientation of the first pump 130 (together or in combination with at least another pump, such as the second pump 140) to obtain sufficient blood outflow for the intended medical purpose.
[0132]
[0147] Although the pumps are described herein as being dockable and connectable to, and undockable and disconnectable from, the pump dock, it will be understood that the docking interactions between the pumps and the pump dock may be other. For example, one or more pumps may be non-removably dockable and / or non-removably connectable to the pump dock.
[0133]
[0148] As illustrated herein, the pumps docked to the pump dock are arranged in a side-by-side or parallel configuration, with the pumps positioned longitudinally parallel to one another.
[0134]
[0149] Alternatively, pumps docked to a pump dock may be arranged in a flared configuration in which the distance separating the distal end portions of the pumps is greater than the distance separating the proximal end portions of the pumps.
[0135]
[0150] Further alternatively, the pump docked to the pump dock may be arranged in an inverted flare configuration in which the distance separating the proximal end portions of the pump is greater than the distance separating the distal end portions of the pump. The arrangement of the pump in parallel, flared, and inverted flare configurations is determined by the design and assembly, including the respective angles of the dock electrical connector, pump electrical connector, dock physical connector, pump physical connector, and pump receiving surface relative to the body of the pump dock.
[0136]
[0151] The modular pump system 100 includes two pumps (i.e., Figures 1A-1C) or three pumps (i.e., Figures 3A-29C) along with a pump dock 110 as shown and described herein, although the modular pump system 100 can be configured to include any number of pumps.
[0137]
[0152] The pumps described and illustrated herein include any implantable blood or heart pump, such as axial, positive displacement and centrifugal pumps.
[0138]
[0153] While this disclosure refers to a "pump," one of ordinary skill in the art will readily appreciate that the pump may in fact be any other medical device and equivalent structure capable of docking and connecting to or undocking and disconnecting from a pump dock for operation. This includes any medical device and equivalent structure that is sized and shaped to be intraluminally delivered to, intraluminally assembled, intraluminally operatively connected to, intraluminally implanted and / or intraluminally extracted from the pump dock. This also includes any medical device and equivalent structure capable of slidable movement relative to the pump dock, e.g., slidable movement within a lumen, for docking to the pump dock for operation.
[0139]
[0154] Such other medical devices and equivalent structures include devices that affect blood flow, balloon pump systems, intraluminal occluders, endovascular prostheses, implantable pacemakers, atrial shunt devices, valve replacement systems and / or valvuloplasty systems.
[0140]
[0155] 2A shows a schematic flow diagram of a method 200 for implanting a modular pump system within a lumen, such as within the vascular system (including the lumen of the aorta and the chambers of the heart), hollow organs, and body cavities, according to one embodiment. In FIG. 2A, solid lines indicate elements of method 200, and dotted lines indicate optional elements of method 200.
[0141]
[0156] A method 200 of implanting a modular pump system (also referred to herein as an intraluminal modular powered medical system) at an intraluminal implantation site within a lumen of a subject includes delivering 201 a modular pump system to the intraluminal implantation site, the modular pump system comprising a pump dock (also referred to herein as an intraluminal dock or an intraluminal control element guide) having a dock electrical connector, and a pump (also referred to herein as an intraluminal medical device and an intraluminal powered medical device) having a pump electrical connector (also referred to herein as a device electrical connector) electrically connectable to the dock electrical connector, and intraluminally connecting the dock electrical connector and the pump electrical connector together to provide power to the pump, at 203.
[0142]
[0157] Intraluminally connecting 203 can include intraluminally connecting a pump electrical connector and a dock electrical connector together at 205A to manipulate a control element of the pump to provide power to the pump. For example, the control element can be positioned and manipulated at its proximal end portion intraluminally, in vivo (but not intraluminally), and / or extracorporeally. The control element can be in slidable relationship with the pump dock, for example, by being slidable within the pump dock, such that the control element is manipulated to slidably move the pump relative to the pump dock.
[0143]
[0158] Connecting 203 may include manipulating an intraluminal extension of the pump dock to intraluminally connect the dock electrical connector and the pump electrical connector together to provide power to the pump at 205B. For example, the intraluminal extension may be positioned and manipulated at its proximal end portion intraluminally, in vivo (but not intraluminally), and / or extracorporeally. The pump dock may be in slidable relationship with the pump, such as by having a slidable control element provided through the pump dock, whereby the intraluminal extension is manipulated to slidably move the pump dock relative to the pump.
[0144]
[0159] Method 200 may further include powering the pump via the pump dock by electrically connecting the pump dock to a power source, such as at a proximal end portion of a power connector on the pump dock, at 207A, or by wirelessly transmitting energy from the power source to the pump dock, at 207B.
[0145]
[0160] Delivering 201 may include, at 209, obtaining an intraluminal access opening for delivering the modular pump system, such as percutaneously, to an intraluminal implantation site.
[0146]
[0161] Delivering 201 may further include, at 211A, introducing a sheath or catheter having at least partially contained therein the modular pump system into the lumen through the intraluminal access opening, at 211B, advancing or guiding the sheath or catheter through the lumen to its intraluminal implantation site, and, at 211C, ejecting (or facilitating ejection) the modular pump assembly from the sheath or catheter at its intraluminal implantation site within the lumen.
[0147]
[0162] The method 200 may further include, at 213, securing the modular pump system at the intraluminal implantation site, such as via a fastener provided on a pump dock.
[0148]
[0163] Delivering 201 may further include, at 215, removing the sheath or catheter from the lumen after the modular pump system has been expelled (or encouraged to exit) from the sheath or catheter at the intraluminal implantation site.
[0149]
[0164] Delivering 201 can further include, at 217, closing the intraluminal access opening, such as by a surgical procedure.
[0150]
[0165] Docking the pump to the pump dock can be performed by pulling the pump's control element to move the pump toward the pump dock for docking and connecting the pump to the pump dock (i.e., when the pump is positioned distally relative to the pump dock, the pump electrical connector (also referred to herein as the device electrical connector) is disposed proximally relative to the pump, and the dock electrical connector is disposed distally relative to the pump dock). Alternatively, the pump's control element can be pushed to move the pump toward the pump dock for docking and connecting the pump to the pump dock (i.e., when the pump is positioned proximally relative to the pump dock, the pump electrical connector is disposed circumferentially relative to the pump, and the dock electrical connector is disposed circumferentially relative to the pump dock).
[0151]
[0166] Docking the pump dock to the pump can also be performed by pushing an intraluminal extension including the power connector of the pump dock (e.g., using a push rod abutting the pump dock) to move the pump dock toward the pump to dock and connect the pump dock to the pump (i.e., when the pump dock is positioned proximally relative to the pump, the dock electrical connector is disposed distally relative to the pump dock, and the pump electrical connector (also referred to herein as the device electrical connector) is disposed proximally relative to the pump). Alternatively, a power control element of the pump dock may be pulled to move the pump dock toward the pump to dock and connect the pump dock to the pump (i.e., when the pump dock is positioned distally relative to the pump, the dock electrical connector is disposed circumferentially relative to the pump, and the dock electrical connector is disposed circumferentially relative to the pump dock).
[0152]
[0167] It will be appreciated that docking between the pump and the pump dock can be achieved by manipulating the pump's control elements and / or the pump dock's power control elements (e.g., by pulling and / or pushing one or both of them).
[0153]
[0168] In some embodiments where the modular pump system includes two pumps (i.e., a first pump and a second pump provided with a first control element and a second control element, respectively), the first pump and the second pump can be implanted from an intraluminal implantation by manipulating the first control element and the second control element, respectively, as in the method of implanting a modular pump system described herein, with necessary mutatis mutandis, where applicable, as would be recognizable to one of skill in the art.
[0154]
[0169] 2B shows a schematic flow diagram of a method 1400 for extracting a modular pump system from a lumen, such as from the vasculature (including the lumen of the aorta and the chambers of the heart), hollow organs and body cavities, according to one embodiment. In FIG. 2B, solid lines indicate elements of method 1400 and dotted lines indicate optional elements of method 1400.
[0155]
[0170] A method 1400 for extracting a modular pump system (also referred to herein as an intraluminal modular powered medical system) from an intraluminal implantation site within a lumen of a subject, the modular pump system comprising a pump dock (also referred to herein as an intraluminal dock or an intraluminal control element guide) having a dock electrical connector, and a pump (also referred to herein as an intraluminal medical device and an intraluminal powered medical device) having a pump electrical connector (also referred to herein as a device electrical connector) electrically disconnectable from the dock electrical connector, the method including, at 1401, intraluminally disconnecting the dock electrical connector and the pump electrical connector from one another to stop the supply of power to the pump, and, at 1403, retrieving the modular pump system from the intraluminal implantation site.
[0156]
[0171] Intraluminally disconnecting 1401 can include manipulating a control element of the pump to intraluminally disconnect the pump electrical connector and the dock electrical connector from one another to stop power to the pump, at 1405A. For example, the control element can be positioned and manipulated at its proximal end portion intraluminally, in vivo (but not intraluminally), and / or extracorporeally. The control element can be in slidable relationship with the pump dock, for example, by being slidable within the pump dock, whereby the control element is manipulated to slidably move the pump relative to the pump dock.
[0157]
[0172] Connecting 1401 may include manipulating an intraluminal extension of the pump dock to intraluminally disconnect the dock electrical connector and the pump electrical connector to discontinue power to the pump at 1405B. For example, the intraluminal extension may be positioned and manipulated at its proximal end portion intraluminally, in vivo (but not intraluminally), and / or extracorporeally. The pump dock may be in slidable relationship with the pump, such as by having a slidable control element provided through the pump dock, whereby the intraluminal extension is manipulated to slidably move the pump dock relative to the pump.
[0158]
[0173] Method 1400 may further include interrupting the supply of power to the pump via the pump dock by electrically disconnecting the pump dock from the power source, such as at a proximal end portion of the pump dock's power connector, at 1407A, or by interrupting wireless energy transmission from the power source to the pump dock, at 1407B.
[0159]
[0174] Retrieving 1403 may include, at 1409, obtaining an intraluminal access opening for retrieving the modular pump system from the intraluminal implantation site, such as percutaneously.
[0160]
[0175] Retrieving 1403 may further include, at 1411A, introducing a sheath or catheter into the lumen through the intraluminal access opening, at 1411B, intraluminally advancing or guiding the sheath or catheter through the lumen to its intraluminal implantation site, and at 1411C, at least partially lifting (or facilitating lifting) the modular pump assembly within the sheath or catheter out of the lumen at its intraluminal implantation site.
[0161]
[0176] The method 1400 may further include, at 1413, unlocking the modular pump system from the intraluminal implantation site, such as via a locking device provided on the pump dock.
[0162]
[0177] The method 1400 may further include, at 1415, removing the sheath or catheter at least partially containing the modular pump system therein from the lumen.
[0163]
[0178] The method 1400 may further include, at 1417, closing the intraluminal access opening, such as by a surgical procedure.
[0164]
[0179] Undocking the pump from the pump dock can be performed by pushing the pump's control element to move the pump away from the pump dock to undock and disconnect the pump from the pump dock (i.e., when the pump is positioned distally relative to the pump dock, the pump electrical connector (also referred to herein as the device electrical connector) is disposed proximally relative to the pump, and the dock electrical connector is disposed distally relative to the pump dock). Alternatively, the pump's control element can be pulled to move the pump away from the pump dock to undock and disconnect the pump from the pump dock (i.e., when the pump is positioned proximally relative to the pump dock, the pump electrical connector is disposed circumferentially relative to the pump, and the dock electrical connector is disposed circumferentially relative to the pump dock).
[0165]
[0180] Undocking the pump dock from the pump can also be performed by pulling an intraluminal extension including the pump dock's power connector to move the pump dock away from the pump to undock and disconnect the pump dock from the pump (i.e., when the pump dock is positioned proximally relative to the pump, the dock electrical connector is disposed distally relative to the pump dock, and the pump electrical connector (also referred to herein as the device electrical connector) is disposed proximally relative to the pump). Alternatively, a power control element on the pump dock may be pushed (e.g., using a push rod abutting the pump dock) to move the pump dock away from the pump to undock and disconnect the pump dock from the pump (i.e., when the pump dock is positioned distally relative to the pump, the dock electrical connector is disposed circumferentially relative to the pump, and the dock electrical connector is disposed circumferentially relative to the pump dock).
[0166]
[0181] It will be appreciated that undocking between the pump and the pump dock can be achieved by manipulating the pump's control elements and / or the pump dock's power control elements (e.g., by pulling and / or pushing one or both of them).
[0167]
[0182] In some embodiments where the modular pump system includes two pumps (i.e., a first pump and a second pump provided with first and second control elements, respectively), the first pump and the second pump can be removed from intraluminal implantation by manipulating the first control element and the second control element, respectively, such as in the method of removing the modular pump system described herein, with any necessary mutatis mutandis, if applicable, as would be recognizable to one of skill in the art.
[0168]
[0183] It will be further appreciated that in some embodiments where the modular pump system includes two or more pumps, each of the pump electrical connectors can be connected to and disconnected from a corresponding connector of the dock electrical connector (i) simultaneously together, and (ii) stepwise relative to one another (e.g., by connecting or disconnecting a first pump, then connecting or disconnecting a second pump, etc.), depending on, for example, how an operator manipulates the proximal end portions of the respective control elements, respectively, and thus similarly for docking and undocking pumps to and from the pump dock.
[0169]
[0184] Intraluminal implantation sites can include implantation sites located within the lumen of a body conduit, such as the lumen of the aorta and the lumens of the vascular system, including the chambers of the heart, hollow viscera and body cavities.
[0170]
[0185] The modular pump system is configured to be delivered transcatheterically for implantation at an intravascular implantation site and retrieved transcatheterically for removal from the intravascular implantation site, which can be, for example, the lumen of the aorta or a chamber of the heart.
[0171]
[0186] For implantation, in use, the modular pump system contained within a catheter (or sheath) is delivered with at least one pump undocked and therefore disconnected from the pump dock (i.e., in an undocked configuration). The catheter (or sheath) is passed through the vasculature to or near the intravascular implantation site. The modular pump system is then ejected from the catheter (or sheath) at or near the implantation site, and the pump is docked to the pump dock, resulting in a docked configuration.
[0172]
[0187] For harvesting, at the time of use, the modular pump system in its docked configuration is retrieved from the intravascular implantation site by undocking, and thus decoupling, at least one pump from the pump dock, and then the modular pump system in its undocked configuration is lifted within the catheter (or sheath) and the catheter is removed from the vasculature.
[0173]
[0188] Although the implantation and description of the modular pump system is described herein as being performed percutaneously or non-percutaneously, via a transcatheter procedure, it will be understood that the modular pump system can also be implanted and removed without a catheter (or sheath).
[0174]
[0189] For implantation, in use, the modular pump system is threaded through the vasculature to an intravascular implantation site without being contained within a catheter (or sheath), and at least one pump is docked to a pump dock. Threading the pump through the vasculature can be accomplished by pulling and / or pushing at least one control element and / or by snaring the pump, as known in the art.
[0175]
[0190] For purposes of illustration, in use, at least one pump is undocked from the pump dock and the modular pump system is removed from the vasculature without being housed in a catheter (or sheath). Retrieval of the pump can be accomplished by pulling on at least one control element and / or by snaring the pump.
[0176]
[0191] 3A-5C illustrate a modular pump system 300 according to one embodiment. The modular pump system 300 may be similar or the same in form and / or function as the modular pump system 100. As such, the portions and components of the modular pump system 300 will not be described in further detail herein. As shown in FIGS. 3A-3D, the modular pump system 300 includes a first pump 330, a second pump 340, and a third pump 350, as well as a pump dock 310 to which the three pumps may be docked. Specifically, as shown in FIGS. 3A and 3D, the pump dock 310 includes a fastener 315 configured to fasten or securely attach the pump dock 310 (e.g., with the pumps 330, 340, and 350 docked thereto) to a lumen of the subject's anatomy.
[0177]
[0192] FIG 3A shows a first pump 330 docked to a pump dock 310, and pumps 340 and 350 operatively coupled to the pump dock 310 but not yet docked. FIG 3B shows all three pumps 330, 340, 350 docked to the pump dock. The pumps 330, 340, 350 each have a pump electrical connector 333, 343, 353 (also referred to herein as a device electrical connector). Each pump electrical connector 333, 343, 353 is a single prong having three conductive sections or rings CR. Each conductive section or ring CR is suitable for a different phase of the motor (not shown) of the modular pump system 300. In this embodiment, each pump includes a single prong having three conductive sections or rings CR, however, in some embodiments, each pump 330, 340, 350 can include multiple prongs, e.g., three prongs, each suitable for a different phase of the motor (e.g., each prong having one conductive section or ring).
[0178]
[0193] Figure 3C shows first pump 330 (which may be the same as or similar in form and / or function to pumps 340 and 350, including first pump electrical connector 133), and Figure 3D shows first pump electrical connector 133 in more detail. As shown, first pump electrical connector 133 is at a distal end of first pump 330 such that first pump 330 can be advanced (e.g., pushed or pulled) toward pump receiving surface 311a (if present) and dock electrical connector 312a such that first pump 330 can make contact therewith.
[0179]
[0194] 4A-4C illustrate this process. In FIG. 4A, the first pump 330 is docked to the pump dock 310 and the second pump 340 is in an undocked configuration with its control element 344 threaded through the dock electrical connector 312b, as shown and described in more detail with reference to FIGS. 5A-5C. FIG. 4B illustrates the second pump 340 in an intermediate configuration between the undocked and docked configurations. FIG. 4C illustrates the second pump 340 docked to the pump dock 310. FIG. 4D illustrates a top view cross section of the pump dock 310 through AA in FIG. 4A. FIG. 4D illustrates the internal cavities (also referred to herein as control element receiving volumes CRV and control element passage guides) circumferentially distributed about the central axis of the pump dock 310 and configured to receive the control elements 334, 344, 354 for connecting and docking to each of the pumps 330, 340, 350. When the pumps 330, 340, 350 are so docked and connected, the control elements 334, 344, 355 of the pumps 330, 340, 350 extend along corresponding lumens through and beyond the pump dock 310 to reach the operator for operation. Also shown in Figures 4D and 5A-5C is an inner or central lumen CL through which the electrical connector EC can pass.
[0180]
[0195] As shown, pump dock 310 defines pump receiving surfaces 311a, 311b, 311c for each of pumps 330, 340, 350, respectively, and three dock electrical connectors 312a, 312b, 312c (also referred to herein as dock electrical connectors) for receiving pump electrical connectors 333, 343, 353, respectively, and respective control elements 334, 344, 354. As shown in Figures 4A-4C and 5A-5C, pump receiving surfaces 311a, 311b, 311c are at least partially defined by protrusions that project distally in a direction away from catheter 316. As shown, each dock electrical connector 312a, 312b, 312c defines a cavity C configured to receive (circumferentially surround) a respective pump electrical connector 333, 343, 353 including a respective control element 334, 344, 354. Each cavity C defines a receiving volume RV for each prong of the pump electrical connector 333, 343, 353 and their respective conductive section or ring CR including the conductive receiving section CRS, thereby collectively providing a physical fit or fixation of the components. The cavity C may include a fluid flush port (not shown) provided at its bottom for draining fluid contained in the cavity C and receiving volume RV when the pump electrical connector is inserted therein to establish an electrical connection.
[0181]
[0196] In this embodiment, each conductive receiving section CRS includes a compressible conductive component, e.g., a spring, coil, etc., configured to align with and circumferentially surround its respective conductive ring CR when each pump electrical connector 333, 343, 353 is docked to establish sufficient electrical contact. For example, the pump electrical connectors 333, 343, 353 (conductive sections or rings CR) and / or the dock electrical connectors 312a, 312b, 312c may be spring-loaded to provide sufficient contact force between the connectors to establish an electrical connection, even in the presence of blood. In this way, for example, each conductive coil can compensate for any misalignment, tolerance variations, and / or irregularities of the mating surfaces, thereby providing electrical contact redundancy. Further, in some embodiments, the compressible conductive component may contribute to coupling or securing the pump electrical connectors 333, 343, 353 within the cavity C by compressive force, and as shown in Figures 5A-5C, an electrical connector EC (e.g., wire, cable, etc.) configured to establish an electrical connection with the respective conductive ring CR is coupled to and extends from each conductive receiving section CRS. Each electrical connector EC is then threaded towards and electrically coupled to a power connector (not shown) similar to the power connector 113 described above.
[0182]
[0197] Each cavity C, in addition to defining a prong receiving volume PRV for receiving the prongs of each pump electrical connector 333, 343, 353, also defines a control element receiving volume CRV (also referred to herein as a control element passage guide) configured to receive a control element 334, 344, 354, as shown. In this manner, each control element 334, 344, 354 may be threaded through the dock, first entering through cavity C (including prong receiving volume PRV and control element receiving volume CRV) and then exiting through an exit portion or aperture of the pump dock 310. The physical coupling or fixation of each pump 330, 340, 350 may be provided by the relative shape and / or volume of cavity C to the prongs of the pump (e.g., cavity C may be shaped and / or sized relative to the prongs of each pump electrical connector 333, 343, 353 to provide an interference fit). Additionally or alternatively, such physical coupling or fixation may be provided by tension applied by each control element 334, 344, 354. By configuring the second pump 340 to be physically secured to the pump dock 310 via the collective mating arrangement of the pump electrical connector 343 and the dock electrical connector 312a, the second pump 340 may be physically secured to the pump dock 310 without any additional securing or retention mechanisms.
[0183]
[0198] While in this embodiment, pump dock 310 includes a particular number and arrangement of cavities, volumes, lumens, etc., in other implementations, the dock can have any suitable number and arrangement of cavities, volumes, lumens, etc., for example, to ensure that the components housed therein have sufficient space to function without any complications or interruptions between them. For example, pump dock 310 may be provided with a female electrical connector and pumps 330, 340, 350 are provided with respective male connectors, whereas pump dock 310 is provided with a male electrical connector and pumps 330, 340, 350 are provided with respective female connectors.
[0184]
[0199] The modular pump system 300 may further include a catheter 316 coupled to the pump dock 310 and configured to extend from the pump dock 310, e.g., to an extravascular location and / or outside the subject's body. The catheter 316 is also configured to define at least one lumen for accommodating the power connector 313, the control elements 334, 344, 355, and / or optional control component 314, similar to that described with respect to the catheter 116.
[0185]
[0200] In some cases, it may be desirable to fluidly seal one or more cavities of a dock prior to docking one or more pumps to the dock, for example to limit or prevent blood from entering the one or more cavities. FIGS. 6A-6E, 7A-7D, and 8A-8C show a modular pump system 400 configured to provide such a fluid seal, according to one embodiment. The modular pump system 400 may be similar or the same in form and / or function as any of the modular pump systems described herein (e.g., modular pump system 100, modular pump system 300, etc.). Accordingly, portions of the modular pump system 400 will not be described in further detail herein, but rather, the focus will be on the portions of the modular pump system 400 configured to provide a fluid seal as described above.
[0186]
[0201] As shown first in a perspective view in FIG. 6E and then in cross-sectional side views in FIGS. 8A-C, the modular pump system 400 includes three seals 450 (also referred to herein as "plugs"). While there are three seals in this embodiment, some embodiments may include any suitable number of seals, for example, depending on and / or corresponding to the number of pumps in the modular pump system. The seals 450 may have any shape, size, and be formed of any material suitable for insertion and placement within the cavity C of the pump dock 410 to plug or seal the respective cavity C to restrict and / or prevent fluid (e.g., blood) from entering the cavity. In some embodiments, for example, each seal 450 may be formed of silicone, thermoplastic elastomer, rubber, polytetrafluoroethylene, or the like. Each seal 450 defines a lumen L extending along its length to allow passage of the control elements 434, 444, 454 therethrough. Lumen L can be shaped and sized to limit and / or prevent any fluid from moving into or through lumen L when control elements 434, 444, 454 are disposed therein. For example, lumen L can be slightly larger in diameter than control elements 434, 444, 454, thereby allowing control elements 434, 444, 454 to translate therethrough. Furthermore, such an arrangement can thus limit or prevent undesirable twisting, kinking, etc. of control elements 434, 444, 454.
[0187]
[0202] In this embodiment, each cavity C of the dock electrical connectors 412a, 412b, 412c (also referred to herein as a dock electrical connector) is shaped and sized to accommodate both (i) a pump electrical connector 433, 443, 453 (also referred to herein as a device electrical connector) (e.g., a respective prong) from each pump 430, 440 (similar to modular pump system 300) and (ii) one of the seals 450. As shown in Figures 4A-4C and 5A-5C, the dock electrical connectors 412a, 412b, 412c are associated with or integral to a pump receiving surface that is defined at least in part by protrusions that project distally in a direction away from the catheter 416.
[0188]
[0203] For simplicity, the following description focuses on a single pump (i.e., pump 430) and associated components, but it should be understood that such description is equally applicable to the other pumps (i.e., pump 440) and associated components of modular pump system 400. In use, as illustrated sequentially throughout Figures 8A-8C, pump dock 410 can be delivered through a subject's vascular system with seal 450 inserted into cavity C, one end of seal 450 terminating at an entrance to cavity C, as shown in Figure 8A, to restrict and / or prevent blood (and / or other fluids) from entering cavity C. Also as illustrated, control element 434 is threaded through lumen L of seal 450.
[0189]
[0204] Similar to what has been described in other embodiments herein, when an operator is ready to dock pump 430 to pump dock 410, the operator can manipulate (e.g., push or pull) control element 434 to advance pump 430 into cavity C. However, in this embodiment, pump electrical connector 433 contacts seal 450, thereby forcing and / or urging seal 450 deeper into cavity C such that seal 450 seats at or near an end of cavity C and / or at or near an interacting surface of prong receiving volume PRV and control element receiving volume CRV (also referred to herein as a control element passage guide), as shown in FIG. In this manner, cavity C can remain free (or substantially free) of blood (and / or other fluids) during delivery of pump dock 410 (via seal 450), during docking (collectively via pump electrical connector 433 and seal 450), and after docking (via pump electrical connector 433).
[0190]
[0205] Although the modular pump system 400 is illustrated and described as having three seals (i.e., one for each pump and each dock cavity), some embodiments may incorporate four or more seals. FIGS. 9A-9E, 10A-10D, and 11A-11C show a modular pump system 500 having six seals 550, according to one embodiment. The modular pump system 500 may be similar or the same in form and / or function as the modular pump system 400, except that the modular pump system 500 includes additional seals 550, as will be described in more detail below. Thus, portions of the modular pump system 500 will not be described in further detail herein, but rather, the focus will be on portions of the modular pump system 500 that are configured to provide a fluid seal via the six seals 550.
[0191]
[0206] In this embodiment, three of the seals 550 are configured to couple to and be disposed about at least a portion of the pump electrical connectors 533, 543, 553, respectively, as shown, for example, in Figures 9C, 9D, and 9E. These three seals are referred to herein as 550A. Seal 550A is open at both ends with a lumen L extending therebetween to accommodate pump electrical connectors 533, 543, 553. Seal 550A is sized and shaped to snugly fit (e.g., with an interference fit) around pump electrical connectors 533, 543, 553, thereby providing a fluid seal therebetween when coupled. Further, at least a distal portion of each seal 550A has a cross-sectional area that is greater than the cross-sectional area of at least the entrance to cavity C, as described in more detail below, and is configured such that the distal portion of seal 550A does not fit within cavity C during docking, but instead abuts against the entrance to cavity C during docking to fluid-tightly seal the entrance.
[0192]
[0207] The other three seals 550, referred to herein as 550B, may be the same as or similar in shape and / or function to seal 450. All of seals 550 may be formed of any suitable material. In some embodiments, for example, seal 550 is formed of silicone.
[0193]
[0208] For simplicity, the following description focuses on a single pump (i.e., pump 530) and associated components, but it should be understood that such description is equally applicable to the other pumps (i.e., pump 540 and seal 550) and associated components of modular pump system 500. In use, as illustrated sequentially in Figures 11A-11C, pump dock 510 can be delivered through a subject's vascular system with seal 550B inserted into cavity C and one end of seal 550A terminating at an entrance to cavity C to restrict and / or prevent blood (and / or other fluids) from entering cavity C, as shown in Figure 11A. Also as illustrated, pump 534 is threaded through lumen L of seal 550B, according to one embodiment.
[0194]
[0209] Additionally, the pump 530 may be delivered through the subject's vasculature with the seal 550A coupled to and disposed about the pump electrical connector 533 (also referred to herein as the device electrical connector) of the pump 530, as shown in FIG. 11A. Similar to what has been described in other embodiments herein, once the operator is ready to dock the pump 530 with the pump dock 510, the operator may manipulate (e.g., push or pull) the pump 534 to advance the pump 534 into the cavity C. However, in this embodiment, the pump electrical connector 533 contacts the seal 550B, thereby forcing and / or driving the seal 550B deeper into the cavity C such that the seal 550B seats at or near an end of the cavity C and / or at or near an interacting surface of the prong receiving volume PRV and the control element receiving volume CRV (also referred to herein as the control element passageway guide), as shown in FIG. 11C. Furthermore, as pump electrical connector 533 approaches the entrance to cavity C for docking, seal 550A disposed about pump electrical connector 533, particularly the distal portion of seal 550A, contacts both pump receiving surface 511A and the portion of pump dock 510 that forms or defines the entrance to cavity C, as shown in FIG. 11B, thereby fluid-tightly sealing cavity C. With seal 550A thus sealed against pump dock 510, the operator can continue to advance pump 530 into cavity C such that pump electrical connector 533 can advance distally to the lumen of seal 550B and through the lumen of seal 550B while keeping seal 550B in fluid-tight contact with the entrance to cavity C. In this manner, pump electrical connector 533 can be inserted into cavity C for docking while maintaining a fluid-tight seal at the entrance to cavity C via seal 550A, and seal 550A can be further urged into cavity C.
[0195]
[0210] As shown in FIGS. 11A-11C, the dock electrical connector is associated with or integral with a pump receiving surface that is defined at least in part by a protrusion that projects distally in a direction away from the catheter.
[0196]
[0211] Thus, cavity C can remain free (or substantially free) of blood (and / or other fluids) during delivery of pump dock 510 (via seal 550A), during docking (collectively via seal 550B and pump electrical connector 533), and after docking (collectively via seal 550B and pump electrical connector 533).
[0197]
[0212] Although some embodiments described herein include pumps having a single prong to accommodate docking, in some cases, the pump can have two or more prongs. Figures 12A-12D, 13A-13D, and 14A-14C show such a modular pump system 600, according to one embodiment. Modular pump system 600 may be similar or the same in form and / or function as any of the modular pump systems described herein, except that modular pump system 600 includes pumps 630, 640, 650, each having two prongs, a first prong being a physical connector 633A, 643A, 653A (also referred to as a pump physical connector or a device physical connector) that facilitates docking into pump dock 610, and a second prong being a pump electrical connector 633, 643, 653 (also referred to as a device electrical connector) that is similar in form and function to other electrical connectors described herein (e.g., pump electrical connectors 333, 343, 353). Thus, portions of modular pump system 600 will not be described in further detail herein.
[0198]
[0213] For simplicity, the following description focuses on a single pump (i.e., pump 630) and associated components, but it should be understood that such description is equally applicable to the other pumps (i.e., pumps 640 and 650) and associated components of modular pump system 600. As shown, pump dock 610 defines two cavities: a physical connector cavity Cp (also referred to herein as a dock physical connector) and an electrical connector cavity Ce (also referred to herein as a dock electrical connector), which is similar in form and function to the other electrical connectors described herein (e.g., dock electrical connectors 312a, 312b, 312c).
[0199]
[0214] The physical connector cavity Cp is configured to receive and be secured to the physical connector 633A when the pump 630 is docked to the pump dock 610, similar to that described in other embodiments herein. The electrical connector cavity Ce is similarly configured to receive and be secured to the electrical connector 633B when the pump 630 is docked to the pump dock 610. The electrical connector cavity Ce defines a receiving volume RV for the electrical connector 633B and its conductive sections or rings CR. The electrical connectors EC (e.g., wires, cables, etc.), which are relatively spaced apart similar to the spacing of the conductive rings CR, are configured to couple to and extend from the electrical connector cavity Ce and establish electrical connections with their respective conductive rings CR, as shown in FIG. 13C. Each electrical connector EC is then threaded towards and electrically coupled to a power connector (not shown), similar to the power connector 113 described above. As also shown, pump 630 includes a control element 634 extending from pump 630 between physical connector 633A and electrical connector 633B. Such an arrangement can help limit or prevent undesired rotation of pump 630 about its axis (e.g., its central axis) during use. Furthermore, in some embodiments, physical connector 633A and electrical connector 633B may have different shapes, sizes and / or materials. For example, physical connector 633A can include a metal, such as Nitinol, and / or can be shaped and / or sized to fit relatively tighter and / or more securely within physical connector cavity Cp.
[0200]
[0215] In some embodiments, rather than a pump having prongs and a conductive ring as described in various embodiments herein, the pump can include a pump electrical connector having prongs with circular or other curved surfaces. The prongs can have conductive detents or projections extending therefrom that are configured to physically and electrically mate with an electrical receiver disposed in the dock. FIGS. 15A-17C show such a modular pump system 700, according to one embodiment. The modular pump system 700 can be similar or the same in form and / or function as any of the modular pump systems described herein, except that the modular pump system 700 includes pumps 730, 740, 750, each having a pump electrical connector 733, 743, 753 (also referred to herein as a device electrical connector) that defines a curved distal end portion having three conductive protrusions CP (each configured for a separate phase, similar to those described in various embodiments herein with respect to the conductive ring). Thus, the portions of the modular pump system 700 will not be described in further detail herein.
[0201]
[0216] For simplicity, the following description focuses on a single pump (i.e., pump 730) and associated components, but it should be understood that such description is equally applicable to the other pumps (i.e., pumps 740 and 750) and associated components of the modular pump system 700. As shown in FIGS. 17A-17C, the pump dock 710 includes a dock electrical connector 712a (also referred to herein as a dock electrical connector) having a cavity C and an electrical receiver ER having three cup- or curve-shaped portions configured to receive and / or mate with a conductive protrusion CP. The cavity C may include a fluid flush port (not shown) at its bottom for draining fluid contained in the cavity C and the receiving volume RV when the pump electrical connector is inserted into the cavity C to establish an electrical connection. The conductive protrusion may have any suitable shape (e.g., convex, dome-shaped, etc.) for mating with the electrical receiver ER. In some implementations, the conductive protrusions CP can allow for a relatively large force to be applied during docking to displace any undesired fluid (e.g., blood) between each conductive protrusion CP and the electrical receiver ER, thereby improving the electrical connection therebetween. As with some embodiments described herein, the dock electrical connector 712a and the pump electrical connector 733 can be shaped and sized to collectively form an interference fit when docked. In this embodiment, the pump dock 710 houses the control element 734 and the dock electrical connector 712a in the same lumen or volume, although in some embodiments, the pump dock 710 can include any suitable characteristic lumen, for example, the dock can include a first lumen for the control element 734 and a separate second lumen for the dock electrical connector 712a (e.g., its connection to the power connector 713).
[0202]
[0217] Various embodiments described herein include modular pump systems having pumps with control elements attached to and extending from the pumps to accommodate delivery and docking of the pumps. In some cases, it may be desirable to detach the control elements from the pump, for example after delivery and docking of the pump. Figures 18A-20C show such a modular pump system 800, according to one embodiment. The modular pump system 800 may be similar or the same in form and / or function as any of the modular pump systems described herein. As such, portions of the modular pump system 800 will not be described in further detail herein.
[0203]
[0218] For simplicity, the following description focuses on a single pump (i.e., pump 830) and associated components, but it should be understood that such description may be equally applicable to the other pumps (i.e., pumps 840 and 850) and associated components of modular pump system 800. In this embodiment, pump 830 is removably attachable to control element 834, and more specifically, pump 830 defines a threaded recess R configured to be threadably coupled to a threaded coupling of control element 834, as shown in FIG. 20A. Threaded recess R is located at a distal end of electrical connector 833 (also referred to herein as device electrical connector) of pump 830. It should be noted that while a threaded coupling is used in this embodiment, in some embodiments, any suitable coupling mechanism and / or arrangement may be used to enable an operator to manipulate the control element (e.g., from outside the subject) to decouple the control element from the pump. For example, the pump 830 may be removably attachable to the control element 834 by a wire threaded through the control element 834, the wire forming a loop or lasso (i.e., like a snare) for removably attaching the pump 830.
[0204]
[0219] In use, as shown sequentially in Figures 20A-20C, similar to prior embodiments described herein, with pump 830 coupled to control element 834, pump 830 can be delivered through the subject's vasculature, and an operator can manipulate (e.g., push or pull) control element 834 to advance pump 830 into cavity C defined by pump dock 810. Once docked, as shown in Figure 20B, an operator can manipulate (e.g., twist, rotate, etc.) control element 834 to disengage and separate control element 834 from threaded recess R and pump 830, and the operator can then withdraw control element 834 from pump dock 810 and, if desired, from the subject's vasculature or body.
[0205]
[0220] In some cases, it may be desirable to have a removably attachable control element threaded through the catheter, whereby the control element is relatively stiffer / harder than the catheter and provides sufficient stiffness and / or tactile feedback for an operator to manipulate the pump within the subject's body, but can be detached and removed from the subject after docking, leaving the relatively more flexible catheter connected to the pump. Figures 21A-22C show such a modular pump system 900, according to one embodiment.
[0206]
[0221] Modular pump system 900 may be similar or the same in form and / or function as any of the modular pump systems described herein (e.g., modular pump system 800), and therefore, portions of modular pump system 900 will not be described in further detail herein.
[0207]
[0222] For simplicity, the following description focuses on a single pump (i.e., pump 930) and associated components, but it should be understood that such description is equally applicable to the other pumps (i.e., pumps 940 and 950) and associated components of modular pump system 900. Similar to modular pump system 800, in this embodiment, control element 934 is configured to be decoupled from pump 930, but here control element 934 is threaded through a lumen of a catheter Ca that is attached to pump 930, and catheter Ca is configured to extend from pump 930 through the subject's vasculature and outside the subject's body when the pump is docked and positioned at its implantation site. In this manner, an operator can manipulate the control element 934 while coupled to the pump 930 to dock the pump 930 to the pump dock 910, and then the operator can detach and remove the control element 934 from the pump 930 (e.g., from the subject's vasculature and / or body), leaving the catheter Ca coupled to and extending from the docked pump 830. Thus, the relatively stiffer / more rigid control element 934 can be removed from the subject's body, while the relatively more flexible catheter can remain in the subject's body and provide access for the introduction of additional components and / or fluids to the implantation site. Such flexibility is suitable for conforming to the subject's vasculature.
[0208]
[0223] As discussed in connection with the modular pump system 100, in some cases it may be desirable to flush the modular pump system to restrict and / or prevent blood in the pump motor. In some cases, heat generated by the modular pump system may heat the blood or otherwise solidify or coagulate, for example to a jelly-like or gelatinous consistency (i.e., causing the formation of a blood clot), which may cause the motor to seize or cease functioning. In some implementations, the pump has a motor, which is completely enclosed and has a magnetic coupling between the motor and the impeller, and such heated blood may get between those magnetically coupled parts, so in such cases it is beneficial to flush the pump and / or motor and provide a fluid, for example, to exit at the interaction surface between the impeller and the pump housing. Any suitable fluid may be used, such as dextrose (e.g., 5%, etc.) or any other biocompatible fluid. Figures 23A-25D show such a modular pump system 1000, according to one embodiment.
[0209]
[0224] Modular pump system 1000 may be similar or the same in form and / or function as any of the modular pump systems described herein (e.g., modular pump system 900), and therefore, portions of modular pump system 1000 will not be described in further detail herein.
[0210]
[0225] For simplicity, the following description focuses on a single pump (i.e., pump 1030) and associated components, but it should be understood that such description is equally applicable to the other pumps (i.e., pumps 1040 and 1050) and associated components of the modular pump system 1000. Similar to the modular pump system 900, in this embodiment, a catheter Ca is coupled to and extends from the pump 1030 and is threaded through the pump dock 1010, as described in the preceding embodiment. The catheter Ca defines a lumen through which a fluid F can be delivered to the pump 1030 from outside the subject's body. The fluid F can be delivered from a reservoir R located outside the subject's body, for example, as shown in FIGS. 25B and 25D. In this embodiment, the catheter Ca can serve both as a conduit for delivering fluid and as a control element 1034 that an operator manipulates to deliver, dock, and / or undock the pump 1030, as described in more detail herein in connection with other embodiments. Nevertheless, in some embodiments, the catheter may define a lumen through which a relatively more rigid (and detachable) control element may pass, as well as a conduit for fluid, similar to that described with respect to the modular pump system 900. In such embodiments, for example, a control element may be passed through the catheter and removably attached to the pump to facilitate docking of the pump, and then the control element may be detached from the pump and withdrawn through the catheter lumen, leaving the catheter connected to the pump. The operator may then deliver a fluid F flush through the catheter lumen, as described above. In further embodiments, the catheter may have multiple lumens, such as a first lumen configured to receive the control element and a separate second lumen configured to receive fluid from a fluid flush device.
[0211]
[0226] Consistent with the desire to minimize the footprint of the modular pump system within the subject's body, including minimizing any components (e.g., power transmission cables, wires, etc.) that extend from the implanted pump and dock, through the subject's vasculature, and / or outside the subject's body, in some embodiments, the modular pump system can transmit power wirelessly. By way of background, such wireless energy transfer can include features similar to those described in U.S. Patent No. 10,143,788, entitled "Transcutaneous Energy Transfer Systems," which is incorporated herein by reference in its entirety. Figures 26A-26D show such a modular pump system 1100, according to one embodiment, including a power connector 1113 that is or has a coil 1113c that (ii) is coupled to a fixture 1115 of a pump dock 1110 and (ii) is configured to receive inductive power from a source located outside the subject's vasculature and / or body. The modular pump system 1100 may be similar or the same in form and / or function as any of the modular pump systems described herein, and therefore, portions of the modular pump system 1100 will not be described in further detail herein.
[0212]
[0227] As shown in Figures 26B and 26C, the pump dock 1110 includes a fixture 1115. A receiver coil 111c (also referred to herein as a "receive coil") formed of wire (and / or any other suitable component) in a disk shape is coupled to the fixture 1115 and extends from an outer surface of the fixture 1115. The modular pump system 1100 also includes an energy storage component (e.g., a battery) (not shown) operably coupled to the coil 1111c and configured to store and / or transfer energy from the coil 1111c to the pumps 1130, 1140, 1150. In use, a transmitter (e.g., a transmit coil) (not shown) can be brought into proximity with the implanted receive coil 111c to transfer power from the transmit coil to the receive coil 111c to power the implanted components of the modular pump system 1100 (pumps 1130, 1140, 1150). It should be noted that the coil 1111c can accommodate expansion and compression of the fastener 1115, for example, during implantation and delivery, respectively.
[0213]
[0228] The receiving coil can have any suitable shape and size. FIGS. 27A-28C show a modular pump system 1200 having a coil 1211c formed of wire (and / or any other suitable components) circumferentially disposed around the fixture 1215, according to one embodiment. In this embodiment, the coil 1211c can accommodate a relatively larger coil, i.e., surface area, as compared to, for example, the modular pump system 1100. Additionally, in this embodiment, the coil 1211c remains between the distal and proximal ends of the fixture 1215, but in some embodiments, the coil 1211c may extend beyond the distal and / or proximal ends of the fixture 1215. Also, in some embodiments, the coil can have other shapes and / or configurations, for example, may have an angled shape and / or have more spaced wires to accommodate expansion and compression of the fixture. Additionally, as best shown in FIG. 28B, the pump dock 1210 includes a battery B electrically coupled to the coil 1211.
[0214]
[0229] In some cases, it may be desirable to push each pump for delivery through the subject's vasculature and dock it to a dock at the implantation site. Figures 29A-29D show such a pump system 1300, according to one embodiment.
[0215]
[0230] Modular pump system 1300 may be similar or the same in form and / or function as any of the modular pump systems described herein, and therefore, portions of modular pump system 1300 will not be described in further detail herein.
[0216]
[0231] For simplicity, the following description focuses on a single pump (i.e., pump 1330) and associated components, but it should be understood that such description is equally applicable to the other pumps (i.e., pumps 1340 and 1350) and associated components of modular pump system 1300.
[0217]
[0232] In this embodiment, the pump 1330 is configured to fit within the lumen of the catheter Ca and be delivered to the implantation site. Although not shown in FIGS. 29A-29C, the modular pump system 1300 includes control elements, similar to those described in some embodiments herein, each of which is configured to be removably attached to the pump so that the control element can be released from the pump during use. In this embodiment, the control elements are sufficiently rigid so that an operator can push a proximal end portion of the control element to advance the distal end of the control element (and components coupled thereto, such as pumps) into the vasculature of a subject, and each pump coupled to each control element can engage and dock with the pump dock 1310. In some embodiments, for example, each control element can be a push rod. Alternatively, a relatively stiff cable or relatively stiff wire can be threaded through the catheter control element of the pump to provide the control element with sufficient stiffness to push the control element. With the control element (not shown) removably attached to the pump 1330, for example, an operator can push the control element and / or the catheter Ca to advance the pump 1330 (along with the catheter Ca) through the subject's vasculature to dock the pump 1330 with the pump dock 1310 at the implantation site. In this embodiment, the pump electrical connector 1333 (also referred to herein as a device electrical connector) protrudes from an outer surface of the pump 1330 spaced apart from the prongs of the pump 1330 as shown and is configured to correspondingly mate with a dock electrical connector 1312a (also referred to herein as a dock electrical connector) of the pump dock 1310, which in this embodiment is a recess R configured to receive and be secured to the pump electrical connector 1333, thereby providing both a physical securing function and an electrical connection for transferring energy from the pump dock 1310 to the pump 1330, similar to that described in connection with various embodiments herein. FIG. 29D shows an enlarged detailed view of dock electrical connector 1312a and pump electrical connector 1343 engaged with dock electrical connector 1312b.
[0218]
[0233] Additionally, as shown throughout Figures 29A-29C, fixture 1315 defines a cell through which pumps docked to pump dock 1310 (eg, pumps 1330 and 1340) can be advanced and positioned.
[0219]
[0234] Detailed embodiments of the present disclosure are disclosed herein for the purpose of describing and illustrating the claimed structures and methods that can be embodied in various forms, but they are not intended to be exhaustive or limited in any way to the disclosed embodiments. Many modifications and variations will become apparent without departing from the scope of the disclosed embodiments. The terms used in this specification are selected to best explain the principles, practical applications, or technical improvements to the current technology of one or more embodiments, or to enable understanding of the embodiments disclosed herein. As stated, details of well-known features and techniques may be omitted to avoid unnecessarily obscuring the embodiments of the present disclosure.
[0220]
[0235] While various embodiments have been described above, it should be understood that they are presented by way of example only and not by way of limitation. Where the schematic diagrams and / or embodiments described above show certain components disposed in certain orientations or positions, the location of the components may be changed. Although embodiments have been specifically shown and described, it will be understood that various changes in form and detail may be made. The embodiments described herein may include various combinations and / or subcombinations of the functions, components and / or features of the different embodiments described. Although various embodiments have been described as having certain combinations of features and / or components, other embodiments are possible having any combination of features and / or components from any of the embodiments described herein (except in mutually exclusive combinations).
[0221]
[0236] The specific configuration of the various components may also vary. For example, the size and specific shape of the various components may differ from the illustrated embodiment while still providing the functionality as described herein. More specifically, the size and shape of the various components may be specifically selected for a desired or intended application. Thus, it should be understood that the size, shape and / or arrangement of the embodiment and / or its components may be adapted for a given application, unless the context explicitly dictates otherwise.
[0222]
[0237] References herein to "in some embodiments," "one embodiment," "an embodiment," "an example embodiment," and the like indicate that the described embodiment may include one or more particular features, structures, or characteristics, but it should be understood that such particular features, structures, or characteristics may or may not be common to all of the disclosed embodiments disclosed herein. Moreover, such phrases do not necessarily refer to any one particular embodiment per se. Thus, when one or more particular features, structures, or characteristics are described in relation to one embodiment, it should be understood that it is within the knowledge of one of ordinary skill in the art to affect such one or more features, structures, or characteristics in relation to other embodiments, where applicable, whether or not explicitly stated.
[0223]
[0238] The parameters, dimensions, materials, and configurations described herein are intended to be examples, and the actual parameters, dimensions, materials, and / or configurations will depend on the given application or applications in which the teachings of the present invention are used. It is therefore to be understood that the foregoing embodiments are presented by way of example only, and that, within the scope of the appended claims and equivalents thereto, the embodiments may be practiced otherwise than as specifically described and claimed. Embodiments of the present disclosure relate to each individual feature, system, article, material, kit, and / or method described herein. In addition, any combination of two or more such features, systems, articles, materials, kits, and / or methods is included within the scope of the present disclosure, if such features, systems, articles, materials, kits, and / or methods are not mutually inconsistent.
[0224]
[0239] Where methods and / or events described above indicate that certain events and / or steps occur in a certain order, the order of certain events and / or steps may be changed. Further, certain events and / or steps may be performed simultaneously in parallel processes, where possible, rather than just sequentially as described above.
[0225]
[0240] As used herein, a component and / or device may be, for example, any assembly and / or set of operatively linked electrical components associated with performing a certain function, and may include, for example, memory, a processor, electrical traces, optical connectors, software (executed in hardware), etc.
Claims
1. A modular, electrically powered medical system that can be implanted in the lumen of a patient, - A dock within a tubular lumen, including at least one dock electrical connector configured to receive power from a power source, - An intraluminal medical device comprising at least one device electrical connector, wherein the at least one device electrical connector is configured to connect to the at least one dock electrical connector within the lumen of the subject and to receive power from the at least one dock electrical connector, A modular, electrically operated medical system with intratubular components.
2. The system according to claim 1, wherein the intraluminal medical device comprises a control element, the control element being configured to operate to connect the at least one device electrical connector and the at least one dock electrical connector to each other, and to disconnect the at least one device electrical connector and the at least one dock electrical connector to each other.
3. The system according to claim 2, wherein the control element includes an end configured to be operated externally by an operator to actuate the control element to connect the at least one device electrical connector and the at least one dock electrical connector to each other, and to disconnect the at least one device electrical connector and the at least one dock electrical connector to each other.
4. The system according to claim 3, wherein the end of the control element is configured to be pulled relative to the in-tube dock in order to connect the at least one device electrical connector and the at least one dock electrical connector to each other.
5. The system according to claim 4, wherein the end of the control element is configured to be pressed against the in-lubricated dock in order to disconnect the at least one device electrical connector and the at least one dock electrical connector from each other.
6. The system according to claim 2, wherein the control element is configured to extend from the at least one device electrical connector.
7. The system according to claim 2, wherein the control element is configured to be detachably attached to the intraluminal medical device.
8. The system according to any one of claims 2 to 7, wherein the control element does not include a conductive material configured to transmit power from the power source to the at least one dock electrical connector.
9. The system according to any one of claims 2 to 7, wherein the control element is a guide wire.
10. The system according to any one of claims 2 to 7, wherein the intraluminal dock comprises a control element passage guide configured to receive the control element inside.
11. The system according to any one of claims 2 to 7, wherein the intraluminal dock comprises a dock physical connector, the intraluminal medical device comprises a device physical connector, and the dock physical connector and the device physical connector are configured to connect to each other when the control element is activated and to disconnect from each other when the control element is activated.
12. The system according to any one of claims 2 to 7, wherein the intraluminal dock comprises an intraluminal extension configured to be connected to the power supply and to transmit power from there to the at least one dock electrical connector.
13. The system according to claim 12, wherein the intraluminal extension comprises a longitudinal channel configured to receive the control element internally.
14. The system according to claim 12, wherein the intraluminal extension comprises a longitudinal channel configured to deliver fluid to the at least one dock electrical connector.
15. The system according to claim 12, wherein the intraluminal extension is configured to operate to connect the at least one device electrical connector and the at least one dock electrical connector to each other, and to disconnect the at least one device electrical connector and the at least one dock electrical connector to each other.
16. The system according to claim 15, wherein the intraluminal extension includes an end portion configured to be operated externally by an operator to operate the intraluminal dock to connect the at least one device electrical connector to the at least one dock electrical connector and to disconnect the at least one device electrical connector to the at least one dock electrical connector.
17. The system according to claim 16, wherein the end of the intraluminal extension is configured to be pressed against the control element to connect the at least one device electrical connector and the at least one dock electrical connector to each other.
18. The system according to claim 17, wherein the end of the intraluminal extension is configured to be pulled relative to the control element in order to separate the at least one device electrical connector and the at least one dock electrical connector from each other.
19. The system according to any one of claims 2 to 7, wherein the at least one dock electrical connector defines a cavity, and the intubate modular electric medical system further comprises a plug configured to form a fluid-sealed seal with the cavity.
20. The system according to claim 19, wherein the control element is passed through the plug.
21. The system according to claim 20, wherein the at least one device electrical connector is configured to contact the plug and drive the plug into the cavity when connected to the at least one dock electrical connector.
22. The system according to claim 19, further comprising a fluid flush port having fluid communication with the cavity, the fluid flush port configured to discharge fluid contained within the cavity when the at least one device electrical connector is connected to the at least one dock electrical connector.
23. The system according to any one of claims 2 to 7, wherein the intraluminal dock and the intraluminal medical device are configured to dock with each other in the lumen of the subject when the at least one device electrical connector is connected to the at least one dock electrical connector, and to undock with each other in the lumen of the subject when the at least one device electrical connector is disconnected from the at least one dock electrical connector.
24. The system according to any one of claims 2 to 7, wherein the intraluminal dock comprises a fixing device configured to fix the intraluminal modular electric medical system within the lumen of the subject.
25. The intraluminal dock includes a plurality of dock electrical connectors, and each of the plurality of dock electrical connectors is configured to receive power from the power supply. Each of the multiple intraluminal medical devices includes its own device electrical connector. The system according to any one of claims 2 to 7, wherein each of the multiple dock electrical connectors is configured to connect simultaneously or sequentially to the respective device electrical connectors of the multiple intraluminal medical devices within the lumen of the subject, and to receive power from each of the multiple dock electrical connectors.
26. The system according to any one of claims 2 to 7, wherein the intraluminal medical device is an implantable transcatheter pump.
27. A tubular modular electric medical system, - An intraluminal motorized medical device including at least one control wire, - An intraluminal control element guide comprising at least one guide hole, wherein the at least one guide hole is configured to receive at least one control wire along the guide hole, and when implanted in the lumen of a subject, the intraluminal control element guide is configured to assemble with the intraluminal motorized medical device by the operation of the at least one control wire, and is further configured to supply power to the intraluminal motorized medical device when assembled with the intraluminal motorized medical device, A modular, electrically operated medical system with intratubular components.
28. The system according to claim 27, wherein the at least one control wire does not contain a conductive material configured to transmit power from a power source to the intratubular motorized medical device.