MAMMALIAN BODY IMPLANTABLE FLUID FLOW INFLUENCING DEVICE
20220296852 · 2022-09-22
Assignee
Inventors
Cpc classification
A61M60/237
HUMAN NECESSITIES
A61F2/90
HUMAN NECESSITIES
A61F2220/0008
HUMAN NECESSITIES
A61M25/0029
HUMAN NECESSITIES
A61M60/882
HUMAN NECESSITIES
A61B2017/00606
HUMAN NECESSITIES
A61M60/414
HUMAN NECESSITIES
A61M25/0012
HUMAN NECESSITIES
International classification
A61F2/24
HUMAN NECESSITIES
Abstract
Mammalian body implantable fluid flow influencing device for influencing flow of a first fluid within a first bodily conduit via a flow of a second fluid within a second bodily conduit, comprising a first and a second working end. Each end has a vaned rotor and an anchor for anchoring that end within a bodily conduit. Each end having a delivery configuration for percutaneous transcatheter endovascular delivery to an implantation site within a bodily conduit. A driveshaft assembly operatively interconnects the second end rotor with the first end rotor to transmit rotational movement of the second rotor to the first rotor. When the device is implanted within the body, the second vaned rotor acts as a turbine and extracts kinetic energy from the second fluid, and the first vaned rotor acts an impeller and imparts kinetic energy to the first fluid. The device is motorless.
Claims
1. A mammalian body intralumenal implantable fluid flow influencing device for influencing flow of a first fluid within a first conduit of the mammalian body via a flow of a second fluid within a second conduit of the mammalian body, the device comprising: a first working end, the first working end having a first vaned rotor and a first anchor for anchoring the first working end within the first conduit, the first working end having a delivery configuration in which it is dimensioned and shaped to be delivered to a first implantation site within the first conduit and having a deployed configuration, a second working end, the second working end having a second vaned rotor and a second anchor for anchoring the second working end within the second conduit, the second working end having a delivery configuration in which it is dimensioned and shaped to be delivered to a second implantation site within the second conduit and having a deployed configuration, and a driveshaft assembly operatively interconnecting the second vaned rotor with the first vaned rotor to transmit rotational movement of the second vaned rotor to the first vaned rotor; the device being motorless; and when the device is implanted within the mammalian body, the second vaned rotor acts as a turbine and is caused to rotate by the flow of the second fluid within the second conduit, thereby extracting kinetic energy from the second fluid, and the first vaned rotor acts an impeller and is caused to rotate as a result of the rotational movement of the second vaned rotor, thereby imparting kinetic energy to the first fluid.
2. The device of claim 1, wherein the first anchor includes a first wire network, the first wire network having a compact configuration and an expanded configuration, the first wire network being in its compact configuration when the first working end is in its delivery configuration, the first wire network being in its expanded configuration when the first working end is in its deployed configuration; and the second anchor includes a second wire network, the second wire network having a compact configuration and an expanded configuration, the second wire network being in its compact configuration when the second working end is in its delivery configuration, the second wire network being in its expanded configuration when the second working end is in its deployed configuration.
3. The device of claim 2, wherein: when the first wire network is in its expanded configuration, the first wire network surrounds the first vaned rotor and exerts a force on the first conduit sufficient to anchor the first working end in place when the device is in operation; and when the second wire network is in its expanded configuration, the second wire network surrounds the second vaned rotor and exerts a force on the second conduit sufficient to anchor the second working end in place when the device is in operation.
4. A method of implanting a motorless intralumenal implantable fluid flow influencing device within a mammalian body, the device having, a first working end, the first working end having a first vaned rotor and a first anchor for anchoring the first working end within the first conduit, the first working end having a delivery configuration in which it is dimensioned and shaped to be delivered to a first implantation site within the first conduit and having a deployed configuration, a second working end, the second working end having a second vaned rotor and a second anchor for anchoring the second working end within the second conduit, the second working end having a delivery configuration in which it is dimensioned and shaped to be delivered to a second implantation site within the second conduit and having a deployed configuration, and a driveshaft assembly operatively interconnecting the second vaned rotor with the first rotor to transmit rotational movement of the second vaned rotor to the first vaned rotor, the method comprising: a) obtaining access to a conduit system of the mammalian body of which the first conduit is a part; b) guiding a guidewire through the conduit system to the first implantation site within first conduit; c) using at least in part the guidewire to access the second conduit from the first conduit; d) guiding the guidewire to the second implantation site within the second conduit; e) railing a delivery sheath along the guidewire through the conduit system, the first conduit, and the second conduit, to the second implantation site; f) advancing the device with the second working end in its delivery configuration and the first working end in its delivery configuration through the delivery sheath second working end first to the second implantation site leaving the first working end of the device inside the first conduit; g) promoting exit of the second working end of the device from the delivery sheath at the second implantation site; h) causing the second working end of the device to adopt its deployed configuration anchoring the second working end of the device in place within the second conduit; i) promoting exit of the first working end of the device from the delivery sheath at the first implantation site; j) causing the first working end of the device to adopt its deployed configuration anchoring the first working end of the device in place within the first conduit; k) withdrawing the delivery sheath from the mammalian body; and l) withdrawing the guidewire from the mammalian body.
5. The method of claim 4, wherein the second implantation site is downstream from an outlet of a powered ventricular assist device.
6. A method of implanting a motorless intralumenal implantable fluid flow influencing device within a mammalian body, the device having, a first working end, the first working end having a first vaned rotor and a first anchor for anchoring the first working end within the first conduit, the first working end having a delivery configuration in which it is dimensioned and shaped to be delivered to a first implantation site within the first conduit and having a deployed configuration, a second working end, the second working end having a second vaned rotor and a second anchor for anchoring the second working end within the second conduit, the second working end having a delivery configuration in which it is dimensioned and shaped to be delivered to a second implantation site within the second conduit and having a deployed configuration, a driveshaft assembly operatively interconnecting the second vaned rotor with the first rotor to transmit rotational movement of the second vaned rotor to the first vaned rotor, a first module, including the first working end and a first portion of the driveshaft assembly, the first portion of the driveshaft assembly having a first connector having a first magnet, and being dimensioned and shaped to be wholly containable within the first conduit when implanted within the mammalian body, and a second module, including the second working end and a second portion of the driveshaft assembly, the second portion of the driveshaft assembly having a second connector having a second magnet, the first connector and the second connector each being structured to form an operative magnetic interconnection with the other without physically crossing walls of the first conduit and the second conduit, and being dimensioned and shaped to be wholly containable within the second conduit when implanted within the mammalian body, the method comprising: a) obtaining first access to a conduit system of the mammalian body of which the first conduit is a part; b) guiding a first guidewire through the conduit system to the first implantation site within first conduit; c) railing a first delivery sheath along the first guidewire through the conduit system and the first conduit to the first implantation site; d) advancing the first module of the device with the first working end in its delivery configuration through the first delivery sheath the first portion of the driveshaft assembly first to the first implantation site; e) promoting exit of the first module of the device from the first delivery sheath at the first implantation site; f) causing the first working end of the device to adopt its deployed configuration anchoring the first working end of the device in place within the first conduit; g) withdrawing the first delivery sheath from the mammalian body; h) withdrawing the first guidewire from the mammalian body; i) obtaining second access to a conduit system of the mammalian body of which the second conduit is a part; j) guiding a second guidewire through the conduit system to the second implantation site within second conduit; k) railing a second delivery sheath along the second guidewire through the conduit system and the second conduit to the second implantation site; l) advancing the second module of the device with the second working end in its delivery configuration through the second delivery sheath the second portion of the driveshaft assembly first to the second implantation site; m) promoting exit of the second module of the device from the second delivery sheath at the second implantation site such that the first connector and the second connector form the operative magnetic interconnection with each other without physically crossing walls of the first conduit and the second conduit; n) causing the second working end of the device to adopt its deployed configuration anchoring the second working end of the device in place within the second conduit; o) withdrawing the second delivery sheath from the mammalian body; and p) withdrawing the second guidewire from the mammalian body.
7. The method of claim 6, wherein the second implantation site is downstream from an outlet of a powered ventricular assist device.
Description
BRIEF DESCRIPTION OF THE DRAWINGS
[0119] For a better understanding of the present technology, as well as other aspects and further features thereof, reference is made to the following detailed description of some embodiments and implementations, which is to be used in conjunction with the accompanying drawings, where:
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DETAILED DESCRIPTION OF SOME EMBODIMENTS AND IMPLEMENTATIONS
Introduction
[0152] Referring to
General Description
[0153] The embodiment of the device 100 shown in
[0154] The device 100 has no motor.
[0155] Referring to
[0156] Although only shown schematically in the drawings, the first anchor 106 is an expanded configuration with the wires 120 of the first wire network exerting sufficient force on the walls of the left pulmonary artery to anchor the first working end 102 in place during operation of the device 100. Similarly, the second anchor 146 is an expanded configuration with the wires 150 of the second wire network exerting sufficient force on the walls of the ascending aorta to anchor the second working end 142 in place during operation of the device 100.
[0157] Referring to
[0158] Although only shown schematically in the drawings, the first anchor 106 is an expanded configuration with the wires 120 of the first wire network exerting sufficient force on the walls of the inferior vena cava to anchor the first working end 102 in place during operation of the device 100. Similarly, the second anchor 146 is an expanded configuration with the wires 150 of the second wire network exerting sufficient force on the walls of the abdominal aorta to anchor the second working end 142 in place during operation of the device 100.
[0159] Depending on many factors, including but not limited to, the state of the health of the patient, the particulars of the assistance the device is to render, the characteristics of the device, and the particulars of the implantation, the device 100 may be implanted on its own (as is shown in the examples in
[0160] Thus, for example, in the case where an LVAD is implanted into a patient, at a high level, the electrical energy supplied to the LVAD (e.g., from a battery or some other power source) is converted by the LVAD's pumping unit into the kinetic energy of the increased blood flow flowing out of the pump. Downstream of the pump outlet, some of this kinetic energy can be extracted from the flowing blood by the device and used to do other work elsewhere in the body without having its own motor or power source.
First Vaned Rotor (Impeller) & Second Vaned Rotor (Turbine)
[0161] Referring to
[0162] In this embodiment, the first vaned rotor 104 is made of titanium, but in other embodiments the first vaned rotor 104 may be made of any other appropriate medical grade material(s). In this embodiment the first vanes 122 are not expandable (as the skilled addressee would understand, expandable vanes are known in the art). In other embodiments, the first vanes 122 may be expandable. In either case, the maximum cross-sectional diameter of the first vaned rotor 104 is typically between 1 mm (3 Fr) and 12 mm (36 Fr) (when expanded in the case of expandable vanes), depending on the patient, the implantation site, etc, as the skilled address would understand. The typical length of the hub 128 is between 3 mm and 50 mm, again depending on the patient, the implantation site, etc., as the skilled address would understand. Finally, the present technology does not require any specific design for the vanes 122 of the first vaned rotor 104. As a skilled addressee would understand appropriate rotor vane design for a particular circumstance is known in the art.
[0163] As was mentioned hereinabove, in this embodiment, the structure of the second working end 142 is the same as that of the first working end 102. Thus, again referring to
[0164] In this embodiment, the second vaned rotor 144 is made of titanium, but in other embodiments the second vaned rotor 144 may be made of any other appropriate medical grade material(s). In this embodiment, the second vanes 152 are not expandable. In other embodiments, the second vanes 152 may be expandable. In either case, the maximum cross-sectional diameter of the second vaned rotor 144 is typically between 1 mm (3 Fr) and 12 mm (36 Fr) (when expanded in the case of expandable vanes), depending on the patient, the implantation site, etc., as the skilled address would understand. The typical length of the hub 158 is between 3 and 50 mm, again depending on the patient, the implantation site, etc., as the skilled address would understand. Finally, the present technology does not require any specific design for the vanes of the second vaned rotor 144. As a skilled addressee would understand, appropriate rotor vane design for a particular circumstance is known in the art.
First Anchor (Wire Network) & Second Anchor (Wire Network)
[0165] As can best be seen in
[0166] The first anchor 106 has an expanded configuration (shown in
[0167] In this embodiment, the first anchor 106 (the first wire network) is biased towards its expanded configuration, but that bias can be overcome via insertion into the lumen 184 of an appropriately sized catheter (e.g., delivery sheath, retrieval sheath) 180 (or a loader) which has a smaller internal diameter than the diameter or the effective diameter of the first anchor 106, e.g., see
[0168] In this embodiment, the first anchor 106 (first wire network) is made of nitinol, a medical grade shape memory alloy. It is the “shape memory” of the nitinol that causes the bias of the first anchor 106 towards its expanded configuration. But, as the skilled addressee would understand, nitinol is deformable from its “remembered shape” in use, without “forgetting” that shape. Thus, it returns to that shape when the forces having caused its deformation are removed. In other embodiments, the first anchor 106 can be made of any other suitable medical grade material or combination of material(s) having the appropriate design characteristics.
[0169] As can best be seen in
[0170] The second anchor 146 (second wire network) has an expanded configuration (shown in
[0171] In this embodiment, the second anchor 146 (second wire network) is biased towards its expanded configuration, but that bias can be overcome via insertion into the lumen 184 of a catheter (e.g., delivery sheath, retrieval sheath) 180 (or a loader) which has a smaller internal diameter than the diameter or the effective diameter of the second anchor 146, see
[0172] In this embodiment, the second anchor 146 (second wire network) is made of nitinol, a medical grade shape memory alloy. In other embodiments, the second anchor 146 can be made of any other suitable medical grade material or combination of material(s) having the appropriate design characteristics.
First Working End & Second Work End Configurations
[0173] As the skilled addressee would understand, the size of catheters for use in human beings is measured according to the French scale (Fr). Such catheters commonly vary in outer diameter between 3 Fr (1 mm) and 36 Fr (12 mm). (The Fr scale may be converted to millimetres by dividing the Fr by 3.). So, for example, if it were determined that a 6 Fr catheter were to be used in a particular procedure, any components to be delivered through that catheter must be selected such that their dimensions and shapes will permit them to be delivered through a catheter of 6 Fr. Thus, in the present context, the device 100 must meet such a limitation.
[0174] Depending on the particular patient and the particular implantation sites of the first working end 102 and the second working end 142 of the device 100, the size of the catheter 180 required may vary. For example, were the device 100 to be implanted within a patient suffering from coronary artery disease with heart failure, their peripheral vasculature through which the catheter 180 must pass may be partially blocked by peripheral artery disease and thus have reduced cross-sectional area as compared with that of a person not suffering from that disease. The surgeon would thus have to select the appropriately sized catheter 180 and device 100 such that the catheter 180 can pass through the minimum available cross-section of the blood vessels, to the implantation sites, and the device 100 can be delivered (e.g., can themselves pass through) via the catheter 180 to the implantation sites as appropriate.
[0175] The first working end 102 and the second working end 142 of the device 100 each have a delivery configuration and a deployed configuration. When in its delivery configuration (e.g., in the catheter 180), the first working end 102 of the device 100 is dimensioned and shaped to be delivered to the first implantation site within the first conduit. Thus, for example, in this embodiment, assuming a 15 Fr (5 mm) catheter 180 were appropriate, the first working end 102 could have an effective diameter of no larger than 5 mm when in its delivery configuration; meaning that both the first vaned rotor 104 and the first anchor 106 in its compact configuration could have an effective diameter of no larger than 5 mm themselves. Similarly, continuing with the same example, the second working end 142 could have an effective diameter of no larger than 5 mm when in its delivery configuration; meaning that both the second vaned rotor 144 and the second anchor 146 in its compact configuration could have an effective diameter of no larger than 5 mm themselves as well.
[0176] In a similar example, in another embodiment, where the first vaned rotor and the second vaned rotor were themselves expandable and therefore had their own compact and expanded configurations, neither the first vaned rotor nor the second vaned rotor could have an effective diameter of no larger than 5 mm when in their compact configurations.
[0177] It should be understood, however, that the maximum effective diameter of the first working end 102 and the second working end 142 in their delivery configurations (and thus the maximum effective diameter of the first anchor 106, the second anchor 146, the first vaned rotor 104, and the second vaned rotor 144 in their compact configurations (in embodiments where they have them)) does not necessarily dictate the size and shape of the first working end 102 and the second working end 142 in their deployed configurations (and thus the maximum effective diameter of the first anchor 106, the second anchor 146, the first vaned rotor 104, and the second vaned rotor 144 in their expanded configurations (in embodiments where they have them)). Thus, while the maximum effective diameter of the first working end 102 and the second working end 142 may be the same for both of them when they are in their delivery configurations, that is not necessarily the case when they are in their deployed configurations. As the first working end 102 is to be implanted at the first implantation site within the first conduit of a particular patient, in its deployed configuration the first working end 102 (and thus the first vaned rotor 104 and the first anchor 106 in their expanded configurations, if such exist in that embodiment) needs to be selected in accordance with the relevant characteristics of the first conduit at the first implantation site in that patient. Similarly, as the second working end 142 is to be implanted at the second implantation site within the second conduit in that patient, in its deployed configuration the second working end 142 (and thus the second vaned rotor 144 and the second anchor 146 in their expanded configurations, if such exist in that embodiment) needs to be selected in accordance the relevant characteristics of the second conduit at the second implantation site in that patient. Thus, in many embodiments, the first working end 102 and the second working end 142 will be differently configured in their deployed configurations.
Drive Shaft Assembly
[0178] In this embodiment of the device 100, as can be best seen in
[0179] At the first working end 102 of the device 100, one end of the protective hollow tubular covering 110 is connected to the outer portion of the first connector 124 so as to be independent from rotational movement of the driveshaft 112 (described below). At the second working end 142 of the device 100, the other end of the protective hollow tubular covering is connected to the outer portion of the second connector 154 so as also to be independent from rotational movement of the driveshaft 112.
[0180] At the first working end 102 of the device 100, within a lumen of the first connector 124, one end of the driveshaft 112 is connected to the shaft 130 of the first vaned rotor 104. Both the shaft 130 and the end of the driveshaft 112 are rotatably supported within the lumen of the first connector 124 (e.g., by appropriate bearings). Thus, the shaft 130 and the driveshaft 112 can rotate freely without rotating the first connector 124 itself. At the second working end 142 of the device 100, within a lumen of the second connector 154, the other end of the driveshaft 112 is connected to the shaft 160 of the second vaned rotor 144. Both the shaft 160 and the end of the driveshaft 112 are rotatably supported within the lumen of the second connector 154 (e.g., by appropriate bearings). Thus, the shaft 160 and the driveshaft 112 can rotate freely without rotating the second connector 154 itself.
[0181] The driveshaft 112 and the lumen of the of the protective hollow tubular covering 110 are sized such that the covering 110 does not interfere with the rotation of the driveshaft 112 during operation of the device. The protective hollow tubular covering 110 covers the entirety of the driveshaft 112 so that no part of the driveshaft is exposed to any part of the patient's body, thus reducing the risk that the driveshaft 112 causes damage within the patient's body. In this embodiment, both the driveshaft 112 and the protective tubular hollow covering 110 are flexible, such that they may conform to a non-linear path between the first working end and the second working end of the device without causing harm to the patient (e.g., see
[0182] The driveshaft assembly 108 is made of conventional materials and is of a design (similar to that of conventional driveshafts of, e.g., intralumenal VADs).
[0183] In the embodiment shown in
[0184] This is not the case, however, in other embodiments. For example,
[0185] In some other embodiments, the gearbox 214 can contain an automatic clutch (to automatically disconnect the first vaned rotor 204 from the rotational movement of the second vaned rotor 244 under particular operating conditions). In yet other embodiments, the gearbox 214 can contain gears that reverse the direction of rotation between the second vaned rotor 244 and the first vaned rotor 204. Finally, in still other embodiments, the gearbox 214 can contain more than one or all of the previously mentioned structures in combination.
Device Implantation & Explanation
[0186] Device 100 can be transcatheterly implanted and explanted using standard conventional techniques. (The WO '765 provides a very detailed description of such techniques, and they are not repeated herein for the sake of brevity.).
[0187] For example, in a device 100 to be implanted in a patient to provide renal support (i.e., support for the patient's kidneys), the implantation site of the turbine (i.e., the second implantation site for the second vaned rotor 144) is within supra-renal descending aorta and the implantation site of the impeller (i.e., the first implantation site for the first vaned rotor 104) is within the inferior vena cava. (The device 100 is selected so as to have a drive assembly of the appropriate length.) Thus, at a high level and broadly speaking, the device 100 can be implanted by the surgeon in the following manner by: (1) Obtaining access to the femoral vein of the patient (e.g., via the well-known Seldinger technique). (2) Guiding a guidewire through the vasculature from the access site in the femoral vein to the first implantation site within the inferior vena cava. (3) Using at least in part the guidewire to access the supra-renal descending aorta from the inferior vena cava (e.g., using a standard transcaval technique as used in transcatheter aortic valve implantations (TAVI's)). (4) Guiding the guidewire to the second implantation site within the supra-renal descending aorta. (5) Railing a delivery sheath along the guidewire through the vasculature of the patient to the second implantation site. (6) Advancing the device 100 with the second working end in its delivery configuration and the first working end in its delivery configuration through the delivery sheath second working end first to the second implantation site in the supra-renal descending aorta, leaving the first working end of the device 100 inside the interior vena cava at the first implantation site. (7) Promoting exit of the second working end of the device 100 from the delivery sheath at the second implantation site in the supra-renal descending aorta, e.g., by partially withdrawing the delivery sheath while keeping the device in place; which in this embodiment causes the second working end of the device to adopt its deployed configuration anchoring the second working end of the device 100 in place at the second implantation site within the supra-renal descending aorta. (8) Promoting exit of the first working end of the device 100 from the delivery sheath at the first implantation site in the inferior vena cava; e.g. by partially withdrawing the delivery sheath while keeping the device 100 in place; which in this embodiment causes the first working end of the device 100 to adopt its deployed configuration anchoring the first working end of the device 100 in place at the first implantation site within the inferior vena cava. (9) Withdrawing the delivery sheath from the patient's body. (10) Withdrawing the guidewire from the patient's body.
[0188] As a second example, in a device 100 to be implanted in a patient to provide right heart support, the implantation site of the turbine (i.e., the second implantation site for the second vaned rotor 144) is within thoracic descending aorta and the implantation site of the impeller (i.e., the first implantation site for the first vaned rotor 104) is within the pulmonary trunk (or within one of the pulmonary arteries). (The device 100 is selected so as to have a drive assembly of the appropriate length.) Thus, at a high level and broadly speaking, the device 100 can be implanted by the surgeon in the following manner by: (1) Obtaining access to the femoral artery of the patient (e.g., via the well-known Seldinger technique). (2) Guiding a guidewire through the vasculature from the access site in the femoral artery to the second implantation site within the thoracic descending aorta. (3) Using at least in part the guidewire to access the pulmonary trunk from the thoracic descending aorta. (4) Guiding the guidewire to the first implantation site within the pulmonary trunk. (5) Railing a delivery sheath along the guidewire through the vasculature of the patient to the first implantation site. (6) Advancing the device 100 with the first working end in its delivery configuration and the second working end in its delivery configuration through the delivery sheath first working end first to the first implantation site in the pulmonary trunk, leaving the second working end of the device 100 inside the thoracic descending aorta at the second implantation site. (7) Promoting exit of the first working end of the device 100 from the delivery sheath at the first implantation site in the pulmonary trunk, e.g., by partially withdrawing the delivery sheath while keeping the device in place; which in this embodiment causes the first working end of the device to adopt its deployed configuration anchoring the first working end of the device 100 in place at the first implantation site within the pulmonary trunk. (8) Promoting exit of the second working end of the device 100 from the delivery sheath at the second implantation site in the thoracic descending aorta; e.g. by partially withdrawing the delivery sheath while keeping the device 100 in place; which in this embodiment causes the second working end of the device 100 to adopt its deployed configuration anchoring the second working end of the device 100 in place at the second implantation site within the thoracic descending aorta. (9) Withdrawing the delivery sheath from the patient's body. (10) Withdrawing the guidewire from the patient's body.
[0189] In both of the above examples, the second vaned rotor of the device may (or may not) be implanted downstream of the outlet of a VAD, if the surgeon so decides for that patient.
[0190] Further, in both of the above examples, the device 100 can be explanted by standard retrieval techniques using a snare and a retrieval sheath as described in the WO '765 Publication.
Operation
[0191] In this embodiment, the device 100 simply operates on its own, without any motor or human intervention. The second vaned rotor 144 (the turbine) is caused to rotate by the flow of blood in the aorta (whether that flow has been augmented by an LVAD or not). The rotational movement of the second vaned rotor 144 is transmitted to the first vaned rotor 104 (the impeller) via the driveshaft 112. The first vaned rotor 104 increases the flow rate of the blood in the inferior vena cava or the pulmonary trunk (as the case may be from the above examples).
Additional Embodiments—Multiple Vaned Rotors
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[0193] In the embodiment shown in
[0194] In the embodiment shown in
[0195] In the embodiment shown in
Additional Embodiments—Device Split into Separate Modules
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[0197] The first portion 408a and the second portion 408b of the driveshaft assembly of device 400 are similar to the driveshaft assembly 108 of device 100. Thus, the first portion 408a of the driveshaft assembly is connected to the first connector 424, which is identical to the first connector 124 of the device 100. The first portion 408a of the driveshaft assembly has a driveshaft 412a which is disposed within the lumen of the protective hollow tubular covering 410a. In this embodiment, the opposite end of the driveshaft 412a of the first module 416 (opposite from the connector 424) has a magnet 418a. Further, the protective hollow tubular covering 410a terminates with a sealed end such that no communication is permitted between the lumen and the external environment of the first module 416.
[0198] Similarly, the second portion 408b of the driveshaft assembly is connected to the second connector 454, which is identical to the second connector 154 of the device 100. The second portion 408b of the driveshaft assembly has a driveshaft 412b which is disposed within the lumen of the protective hollow tubular covering 410b. In this embodiment, the opposite end of the driveshaft 412b of the second module 436 (opposite from the connector 454) has a magnet 418b. Further, the protective hollow tubular covering 410b terminates with a sealed end such that no communication is permitted between the lumen and the external environment of the second module 416.
[0199] The magnet 418a of the first module 416 and the magnet 418b of the second module 436 are structured to operatively interconnect with each other such that rotational movement of the magnet 418b of the second module 436 is transmitted to the magnet 418a of the first module 416. (Depending on the embodiment and the environment in which the device 400 is implanted, the operative distance between the magnets 418b and 418a varies. Thus, in some embodiments the magnets 418a, 418b physically touch one another whereas in other embodiments the magnets 418a, 418b have a gap between them and remain operatively connected). Thus, in some cases, the first module 416 is dimensioned and shaped to be wholly containable within the first conduit when implanted within the mammalian body and the second module is dimensioned and shaped to be wholly containable within the second conduit when implanted within the mammalian body, with the gap between the magnets 418a, 418b (when the first module 416 and the second module 436 are implanted with the body) being within the operative distance between the magnets 418a, 418b. Thus, it is not necessary to make openings in the walls of the first and second conduits for the device to be implanted, operable, or explanted.
[0200] Each of the first and second modules 316, 336 can be transcatheterly implanted and explanted using standard conventional techniques.
[0201] As an example, in a device 300 to be implanted in a patient to provide renal support (i.e., support for the patient's kidneys), the implantation site of the turbine (i.e., the second implantation site for the second vaned rotor 144) is within supra-renal descending aorta and the implantation site of the impeller (i.e., the first implantation site for the first vaned rotor 104) is within the inferior vena cava. (The device 300 is selected so that each of the first and the second modules 316, 336 have driveshaft assemblies 108a, 108b of the appropriate length, have sufficient flexibility, and have magnets of appropriate strength.) Thus, at a high level and broadly speaking, the device 300 can be implanted by the surgeon in the following manner by: (1) Obtaining first access to the femoral vein of the patient. (2) Guiding a first guidewire through the vasculature from the access site in the femoral vein to the first implantation site within the inferior vena cava. (3) Railing a first delivery sheath along the first guidewire through the vasculature to the first implantation site within the inferior vena cava. (4) Advancing the first module 316 of the device 300 with the first working end in its delivery configuration through the first delivery sheath the first portion of the driveshaft assembly first to the first implantation site within the inferior vena cava. (5) Promoting exit of the first module 316 of the device 300 from the first delivery sheath at the first implantation site within the inferior vena cava; which in this embodiment causes the first working end of the device 300 to adopt its deployed configuration anchoring the first working end of the device 300 in place within the inferior vena cava. (6) Withdrawing the first delivery sheath from the patient. (7) Withdrawing the first guidewire from the patient. (8) Obtaining second access to the axillary artery of the patient. (9) Guiding a second guidewire through the vasculature from the access site in the axillary artery to the second implantation site within supra-renal descending aorta. (10) Railing a second delivery sheath along the second guidewire through the vasculature to the second implantation site within supra-renal descending aorta. (11) Advancing the second module 336 of the device 300 with the second working end in its delivery configuration through the second delivery sheath the second portion of the driveshaft assembly first to the second implantation site within supra-renal descending aorta. (12) Promoting exit of the second module 336 of the device 300 from the second delivery sheath at the second implantation site within supra-renal descending aorta such that the first magnet 418a and the second magnet 418b form the operative magnetic interconnection with each other without physically crossing walls of the inferior vena cava or the supra-renal descending aorta, which in this embodiment causes the second working end of the device 300 to adopt its deployed configuration anchoring the second working end of the device 300 in place within supra-renal descending aorta. (13) Withdrawing the second delivery sheath from the patient. (14) Withdrawing the second guidewire from the patient.
[0202] In the above example, the second vaned rotor of the device may (or may not) be implanted downstream of the outlet of a VAD, if the surgeon so decides for that patient.
[0203] Further, the first and second modules 316, 336 can be explanted by standard retrieval techniques using a snare and a retrieval sheath as described in the WO '765 Publication.
Additional Embodiments—Device with Self-Expanding Sealing Units
[0204] In employing some embodiments implementations of the present technology, it may be necessary to seal either one or both of the openings made in the first conduit and the second conduit to allow the driveshaft assembly to pass from the interior of the first conduit (from the first working end) to the interior of the second conduit (to the second working end). Conventional sealing techniques (with which the skilled address would understand) may be used.
[0205] Alternatively, in some embodiments, devices of the present technology may include self-expanding sealing units and/or seals, which the surgeon may wish to use.
[0206] With reference to
[0207] The sealing unit 870 thus has a compact/delivery configuration and an expanded/deployed configuration and is biased towards its expanded/deployed configuration. The sealing unit 870 is in its compact/delivery configuration when in a loader or a catheter (e.g., a delivery sheath, a retrieval sheath, etc.). During implantation of the device 800, as the sealing unit 870 exits the delivery sheath it adopts its expanded/deployed configuration.
[0208] The wire network is covered with a medical grade polymeric sheet 876. When the sealing unit is in its expanded/deployed configuration, each of its ends 872, 873 can act as seals to seal openings in the first conduit and second conduit respectively. The surgeon selects the device 800 having a sealing unit 870 having the appropriate dimensions and shape (prior to implantation of the device 800) to accomplish this purpose, and positions the sealing unit 870 appropriately to seal both conduits during device implant.
[0209] During explanation of the device 800, as the device 800 enters a retrieval sheath, the sealing unit 870 adopts its compact/delivery configuration, unsealing the openings and allowing for retrieval of the device 800.
[0210] With reference to
[0211] The sealing units 970a, 970b (being of a similar construction as with the first anchor of the first working end 902 and the second anchor of the second working end 942) including their disks 972, 973, 977, 978, thus each have a compact/delivery configuration and an expanded/deployed configuration and are biased towards their expanded/deployed configuration. The sealing units 970a, 970b and their disks 972, 973, 977, 978 are in their compact/delivery configuration when in a loader or a catheter (e.g., a delivery sheath, a retrieval sheath, etc.). During implantation of the device 900, as each disk 972, 973, 977, 978 (as the case may be) of each the sealing unit 970a, 970b exits the delivery sheath that disk adopts its expanded/deployed configuration.
[0212] The wire networks of each disk 972, 973, 977, 978 are covered with a medical grade polymeric sheet 976. When a sealing unit 970a, 970b is in its expanded/deployed configuration, each of its disks 972, 973, 977, 978 can act as a seal to seal openings in the first conduit and second conduit (as the case may be). In this particular embodiment, both the interior surface and the exterior surface of each conduit have a disk positioned against them, and thus each sealing unit seals its opening from both sides. Thus, when appropriately positioned, in the expanded/deployed configuration, disk 973 of sealing unit 970b seals the opening in the wall of the second conduit from the inside and disk 977 of sealing unit 970b seals that opening in the wall of the second conduit from the outside. Similarly, when appropriately positioned, in the expanded/deployed configuration, disk 972 of sealing unit 970a seals the opening in the wall of the first conduit from the inside and disk 978 of sealing unit 970a seals that opening in the wall of the first conduit from the outside.
[0213] The surgeon selects the device 900 having sealing units 970a, 970b having disks 972, 973, 977, 978 having the appropriate dimensions, shape and locations (prior to implantation of the device 900) to accomplish this purpose, and positions the sealing units 970a, 970b and their disks 972, 973, 977, 978 appropriately to seal both conduits during the device implant.
[0214] During explanation of the device 900, as the device 900 enters a retrieval sheath, the sealing units 970a, 970b adopt their compact/delivery configuration, unsealing the openings and allowing for retrieval of the device 900.
[0215] With reference to
[0216] In this embodiment, the sealing unit 1070 is wire network (having wires 1071) the central portion of which is in the shape of a large central wire network (similar to sealing unit 870 of device 800) but having two longitudinal ends 1077, 1078 in the shape of radially extending disks. Slightly spaced apart from each longitudinal end 1077, 1078 of the central portion is a radially extending disk 1072, 1073. Disk 1072 is slightly spaced apart from end 1078. Disk 1073 is slight spaced apart from end 1077.
[0217] The sealing unit 1070 (being of a similar construction as with the first anchor of the first working end 1002 and the second anchor of the second working end 1042) including its ends 1077, 1078 and the disks 1072, 1073, thus each have a compact/delivery configuration and an expanded/deployed configuration and are biased towards their expanded/deployed configuration. The sealing unit 1070 is in its compact/delivery configuration when in a loader or a catheter (e.g., a delivery sheath, a retrieval sheath, etc.). During implantation of the device 1000, the sealing unit 1070 including its ends 1077, 1078 and the disks 1072, 1073 as they exit the delivery sheath adopt their expanded/deployed configuration.
[0218] The wire network of the sealing unit 1070 is covered with a medical grade polymeric sheet 1076. When sealing unit 1070 is in its expanded/deployed configuration, each of its ends 1077, 1078 and each of its disks 1072, 1073 can act as a seal to seal openings in the first conduit and second conduit (as the case may be). In this particular embodiment, both the interior surface and the exterior surface of each conduit have one of an end 1077, 1078 or a disk 1072, 1073 positioned against them, and thus the sealing unit 1070 seals the openings in both conduits from both sides. Thus, when appropriately positioned, in the expanded/deployed configuration, disk 1073 of sealing unit 1070 seals the opening in the wall of the second conduit from the inside and end 1077 of sealing unit 1070 seals that opening in the wall of the second conduit from the outside. Similarly, when appropriately positioned, in the expanded/deployed configuration, disk 1072 of sealing unit 1070 seals the opening in the wall of the first conduit from the inside and end 1078 of sealing unit 1070 seals that opening in the wall of the first conduit from the outside.
[0219] The surgeon selects the device 100 having a sealing unit 1070 with component parts having the appropriate dimensions, shape and locations (prior to implantation of the device 1000) to accomplish this purpose, and positions the central portion (and particularly the ends 1077, 1078 thereof) and the disks 1072, 1073 appropriately to seal both conduits during the device implant.
[0220] During explanation of the device 1000, as the device 1000 enters a retrieval sheath, the sealing unit 1070 (including its various component parts) adopt their compact/delivery configuration, unsealing the openings and allowing for retrieval of the device 1000.
ADDITIONAL INFORMATION & INCORPORATIONS-BY-REFERENCE
[0221] As a skilled addressee would understand, percutaneously transcatheterly implantable intralumenal blood pumps (device to which the device 100 of the present technology is related) are well known in the art. Thus, for purposes of brevity, no attempt has been made herein to describe many conventional details with which the skilled addressee would be familiar. However, to facilitate understanding of such devices (e.g., by readers not skilled in the art), reference may be had to one or more of the following patent documents, which are incorporated herein by reference in their entirety for all purposes: [0222] United States Patent Application Publication No. US 2020/0405926 A1 (Alexander et al.), published Dec. 31, 2020, entitled “Removable Mechanical Circulatory Support for Short Term Use”; and [0223] U.S. Pat. No. 10,722,631 B2 (Salahieh et al.), issued Jul. 29, 2020, entitled
[0224] “Intravascular Blood Pumps and Methods of Use and Manufacture”.
[0225] The above list is not intended to be a complete list for any purpose. It is only intended to provide some examples of some documents believed to be potentially useful. Percutaneously transcatheterly implantable intravascular blood pumps have been described in the literature at least since the 1980's, and thus there are many documents that might be helpful that are not set forth above.
[0226] In addition, the following patent document commonly owned by the assignee of the present application is also incorporated herein by reference in its entirety for all purposes. This document may also provide additional background, especially to the unskilled reader: [0227] Int'l Pat. App. No. PCT/US2021/012083 (Puzzle Medical Devices Inc, et al.), filed Jan. 4, 2021, entitled “Mammalian Body Conduit Intralumenal Device and Lumen Wall Anchor Assembly, Components Thereof and Methods of Implantation and Explantation Thereof”.
MISCELLANEOUS
[0228] The present technology is not limited in its application to the details of construction and the arrangement of components set forth in the preceding description or illustrated in the drawings. The present technology is capable of other embodiments and of being practiced or of being carried out in various ways. Also, the phraseology and terminology used herein is for the purpose of description and should not be regarded as limiting. The use of “including”, “comprising”, or “having”, “containing”, “involving” and variations thereof herein, is meant to encompass the items listed thereafter as well as, optionally, additional items. In the description the same numerical references refer to similar elements.
[0229] It must be noted that, as used in this specification and the appended claims, the singular form “a”, “an” and “the” include plural referents unless the context clearly dictates otherwise.
[0230] As used herein, the term “about” or “generally” or the like in the context of a given value or range (whether direct or indirect, e.g., “generally in line”, “generally aligned”, “generally parallel”, etc.) refers to a value or range that is within 20%, preferably within 10%, and more preferably within 5% of the given value or range.
[0231] As used herein, the term “and/or” is to be taken as specific disclosure of each of the two 10 specified features or components with or without the other. For example, “A and/or B” is to be taken as specific disclosure of each of (i) A, (ii) B and (iii) A and B, just as if each is set out individually herein.
[0232] Modifications and improvements to the above-described implementations of the present technology may become apparent to those skilled in the art. The foregoing description is intended to be exemplary rather than limiting. The scope of the present technology is therefore intended to be limited solely by the scope of the appended claims.