Devices and methods for blood flow regulation
A vascular constricting device for constricting vascular lumens to regulate blood flow in a vascular system includes a cuff having an inflatable body and a frame adapted for wrapping round a vascular lumen, such as a native blood vessel or non-native graft, and a pump having an internal reservoir for doling a fluid and a fluid circuit for controlling the flow of fluid between the reservoir and the inflatable body for selectively inflating and deflating the inflatable body. In a hemodialysis treatment, the vascular constricting device is actuated to inflate the inflatable body to restrict blood flow and lower blood flow rate during off-treatment periods, and is actuated to deflate the inflatable body to permit an unrestricted blood flow and a higher blood flow rate during on-treatment periods.
1 . A blood flow regulator for regulating a blood flow adjacent to an arteriovenous junction, the blood flow regulator comprising:
a vascular fitment adapted for implantation at a vascular lumen, the vascular fitment comprising an adjustable flow restrictor adapted for influencing a blood flow rate through the vascular lumen and a protective frame enclosing the flow restrictor; and
a flow controller adapted to communicate with the flow restrictor for controlling adjustment of the flow restrictor, wherein
the flow restrictor is adjustable between at least a first state for permitting a first blood flow rate through the vascular lumen and a second state for permitting a second blood flow rate through the vascular lumen, the first and second blood flow rates differing from one another, and
the protective frame comprises a plurality of pores formed therein, the plurality of pores comprising pores of varying sizes in which relatively larger pores are provided at a first end of the protective frame and relatively smaller pores are provided at a second end of the protective frame.
2 . The blood flow regulator according to claim 1 , wherein
the vascular fitment further comprises a coating provided between the flow restrictor and the protective frame, the coating being formed of a material that promotes adhesion between the flow restrictor and the protective frame.
3 . The blood flow regulator according to claim 2 , wherein
the coating is applied to encapsulate the protective frame with the coating distributed through the plurality of pores.
4 . The blood flow regulator according to claim 2 , wherein
the coating is applied only on an interior surface of the protective frame.
5 . The blood flow regulator according to claim 3 , wherein
the protective frame is made of at least one material selected from: polyethylene terephthalate (PET), polytetrafluoroethylene (ePTFE), nylon, polypropylene, thermoplastic polyurethane (TPU), Polyether ether ketone (PEEK), cobalt chromium, and Nitinol.
6 . The blood flow regulator according to claim 3 , wherein
the coating is made of at least one material selected from: a thermoplastic elastomer (TPE) and a thermoset elastomer (TSE).
7 . The coating according to claim 6 , wherein
the coating is made of a thermoplastic polyurethane (TPU).
8 . The blood flow regulator according to claim 1 , wherein
the plurality of pores are dimensioned to resist the passage of a cannulation needle and thereby protect against damage to the flow restrictor.
9 . The blood flow regulator according to claim 1 , wherein
the size of the pores gradually decreases from the relatively larger pores at the first end to the relatively smaller pores at the second end.
10 . The blood flow regulator according to claim 1 , wherein
the flow restrictor is adjustable between a first state having a first volume and a second state having a second volume, the second volume being greater than the first volume, and
the flow restrictor is adapted such that changes between the first volume and the second volume occur substantially uniformly throughout the flow restrictor.
11 . The blood flow regulator according to claim 10 , wherein
the flow restrictor comprises an inflatable body adapted for adjustment between a the first state being a deflated state having the first volume and the second state being an inflated state having the second volume, and
the inflatable body comprises a perimeter that defines an interior space for reception of a fluid flow for inflating the inflatable body, and a number of flow barriers within the interior space for guiding a fluid flow for promoting a substantially uniform distribution of a fluid flow within the interior space.
12 . The blood flow regulator according to claim 11 , wherein
the vascular fitment further comprises a coating provided between the protective frame and the inflatable body, the coating having the same mechano-chemical properties as the inflatable body.
13 . The blood flow regulator according to claim 12 , wherein
the coating is the made of the same material as the inflatable body.
14 . The blood flow regulator according to claim 11 , wherein
the inflatable body is made of at least one material selected from: a thermoplastic elastomer (TPE) and a thermoset elastomer (TSE).
15 . The blood flow regulator according to claim 11 , wherein
at least one inner surface of the inflatable body has a roughened texture that prevents interior inner surfaces of the inflatable body from adhering to one another.
16 . The blood flow regulator according to claim 15 , wherein
an outer surface of the inflatable body has a smoothened texture for reducing friction between the inflatable body and a vascular lumen upon inflation and deflation of the inflatable body.
17 . The blood flow regulator according to claim 11 , wherein
the flow barriers are heat-fused, ultrasonic, or radio-frequency welds between opposing surfaces of the inflatable body.
18 . The blood flow regulator according to claim 11 , wherein
a plurality of the number of flow barriers aligned along a length of the inflatable body separate the interior space into multiple regions of equal volume and define multiple fluid flow channels that promote uniform distribution of a fluid flow between an inlet to the interior space and the separate regions.
19 . The blood flow regulator according to claim 11 , wherein
the vascular fitment is adapted for implantation around an outer circumference of a vascular lumen such that inflation of the inflatable body constricts a diameter of the vascular lumen to achieve a relatively lower blood flow rate and deflation of the inflatable body permits distension of a diameter of the vascular lumen to achieve a relatively higher blood flow rate.
20 . The blood flow regulator according to claim 11 , wherein
the vascular fitment comprises a fixation mechanism for fixing the vascular fitment in place proximate to an arteriovenous junction.
21 . The blood flow regulator according to claim 19 , wherein
the inflatable body comprises an exhaust valve that limits inflation of the inflatable body to a predetermined threshold.
22 . The blood flow regulator according to claim 21 , wherein
the exhaust valve comprises at least one one-way elastic leaf valve that opens to provide a fluid flow path between the interior space of the inflatable body and an outside of the inflatable body.
23 . The blood flow regulator according to claim 21 , wherein
the exhaust valve is adapted to provide a fluid flow path between the interior space of the inflatable body and a collection chamber.
24 . The blood flow regulator according to claim 23 , wherein
the collection chamber is formed from a diffusible material that enables the diffusion of small molecules from an interior of the collection chamber to an exterior of the collection chamber.
25 . The blood flow regulator according to claim 19 , wherein
the protective frame surrounds an outer periphery of the inflatable body to bias inflation of the inflatable body in a radially inward direction for applying pressure against an outer circumference of a vascular lumen.
26 . The blood flow regulator according to claim 25 , wherein
the protective frame and the inflatable body share a common geometrical shape.
27 . The blood flow regulator according to claim 26 , wherein
the common geometrical shape of the protective frame and the inflatable body is a cylindrical shape or a conical shape.
28 . The blood flow regulator according to claim 25 , wherein
the protective frame is made sufficiently flexible such that the protective frame adapts to the shape and geometry of the vascular lumen.
29 . The blood flow regulator according to claim 25 , wherein
the protective frame comprises a closure mechanism for joining first and second ends of the protective frame to one another, and further preventing biased inflation of the inflatable body in an outward direction.
30 . The blood flow regulator according to claim 29 , wherein
the closure mechanism comprises at least one of: hooks, eyes, zip locks, latches, straps, clips, or combinations thereof.
31 . The blood flow regulator according to claim 11 , wherein
the flow controller comprises a fluid reservoir and a fluid conduit for communicating a fluid flow between the fluid reservoir and the vascular fitment for adjusting the inflatable body between the first deflated state and the second inflated state.
32 . The blood flow regulator according to claim 31 , wherein
the flow controller further comprises a fluid circuit between the fluid reservoir and the fluid conduit, the fluid circuit having a discharging path for discharging a fluid flow from the fluid reservoir to the inflatable body via the fluid conduit and a return path for returning a fluid from the inflatable body to the fluid reservoir via the fluid conduit.
33 . The blood flow regulator according to claim 32 , wherein
the flow controller comprises a pump housing the fluid circuit, and the fluid reservoir is integrated with the pump.
34 . The blood flow regulator according to claim 32 , wherein
the flow controller comprises a pump housing the fluid circuit, and the fluid reservoir is independent from the pump with a second fluid conduit provided for communicating a fluid flow between the fluid reservoir and the pump.
35 . The blood flow regulator according to claim 31 , wherein
the discharge path is configured to discharge multiple fluid flows from the fluid reservoir to the inflatable body in discrete volumes over multiple activations of an actuable-surface, and the return path is configured to return substantially all fluid stored in the inflatable body to the fluid reservoir in a single activation of an actuable-surface.
36 . The blood flow regulator according to claim 35 , wherein
the discharge path is configured to discharge fluid upon actuation of a first actuable-surface and the return path is configured to return fluid upon actuation of a second, different actuable-surface.
37 . The blood flow regulator according to claim 36 , wherein
the first actuable-surface is a compressible elastic dome having an interior space for reception of a volume of fluid, the elastic dome being configured such that, upon application of a pressure thereto, the elastic dome compresses to force a first volume of fluid contained within the interior space through the fluid conduit for delivery to the inflatable body, and upon release of the pressure thereto, the elastic dome rebounds to a non-compressed state and creates a vacuum force that draws a second volume from the fluid reservoir and into the fluid circuit for reception in the interior space.
38 . The blood flow regulator according to claim 37 , wherein
the interior space of the elastic dome is provided with a defined volume such that each application and release of a pressure to the elastic dome results in a substantially identical volume of fluid being drawn into the interior space of the elastic dome.
39 . The blood flow regulator according to claim 37 , wherein
the fluid circuit is configured to provide a one-way flow of fluid upon actuation.
40 . The blood flow regulator according to claim 39 , wherein
the fluid circuit comprises a first pressure valve that restricts a flow of fluid into the interior space of the elastic dome, and a second pressure valve that restricts a flow of fluid out from the interior space of the elastic dome,
the first and second pressure valves are configured such that
upon compression of the elastic dome, an increased pressure applied on a first volume of fluid contained within the interior space of the elastic dome causes the second pressure valve to open for receiving the first volume of fluid, while the first pressure valve remains closed, and
upon rebound of the elastic dome, an increased vacuum force within the interior space of the elastic dome causes the first pressure valve to open for delivering a second volume of fluid for reception within the interior space of the elastic dome, while the second pressure valve closes.
41 . The blood flow regulator according to claim 36 , wherein
the second actuable-surface is a pressure button that opens the return path to bypass a flow restriction controlled by the first actuable-surface.
42 . The blood flow regulator according to claim 41 , wherein
the pressure button is configured, upon application of a pressure thereto, to drive a push rod to force open a pressure valve for opening the return path, and upon release of the pressure thereto, to permit withdrawal of the push rod and closure of the pressure valve.
43 . The blood flow regulator according to claim 36 , wherein
the actuable-surfaces may be any combination of mechanically, electrically, pneumatically, and hydraulically actuable surfaces.
44 . The blood flow regulator according to claim 31 , wherein
the fluid reservoir comprises an embedded port that is adapted to provide a fluid path for refilling the fluid reservoir.
45 . The blood flow regulator according to claim 44 , wherein
the embedded port is adapted for access by a surgical needle for refilling the fluid reservoir subsequent to implantation of the blood flow regulator.
46 . The blood flow regulator according to claim 32 , wherein
the flow controller further comprises at least one valve for controlling a fluid flow through the fluid circuit and a security mechanism adapted to prevent unattended activation of the blood flow regulator by blocking a fluid flow through the at least one valve.
47 . The blood flow regulator according to claim 46 , wherein
the security mechanism is adapted for mechanical and/or magnetic activation for enabling the at last one valve to permit a fluid flow through the fluid circuit between the fluid reservoir and the inflatable body.
48 . The blood flow regulator according to claim 31 , wherein
the inflatable body is adapted to receive a fluid flow from the fluid reservoir, in the form of a liquid flow, that fills and inflates the inflatable body against an outer wall of a vascular lumen.
49 . The blood flow regulator according to claim 48 , wherein
the liquid flow comprises at least one of: medical grade saline, water, oil, glycerol, or a combination thereof.
50 . The blood flow regulator according to claim 48 , wherein the inflatable body comprises multiple layers.
51 . The blood flow regulator according to claim 48 , wherein
the inflatable body comprises a protective layer that resists diffusion of the liquid flow through the inflatable body.
52 . The blood flow regulator according to claim 51 , wherein
the protective layer comprises a material that mitigates the passage of liquid molecules through pores in the inflatable body.
53 . A method of making a blood flow regulator according to claim 2 , comprising
applying a coating material to the protective frame in a liquid state, and hardening the coating material to a solid state to form the coating.
54 . The method according to claim 53 , wherein
the coating material is applied by one of: brushing, dip-coating, spraying, or spin coating.
55 . A method of configuring a vascular lumen comprising:
implanting a blood flow regulator according to claim 1 with the vascular fitment positioned at a vascular lumen.
56 . The method according to claim 55 , wherein
the vascular lumen is a vein, and the vascular fitment is positioned at a downstream position of the vein, in a blood flow direction, from an anastomosis that provides a blood flow connection between the vein and an artery.
57 . The method according to claim 55 , wherein
the vascular lumen is an artery, and the vascular fitment is positioned at an upstream position of the artery, in a blood flow direction, from an anastomosis that provides a blood flow connection between the artery and a vein.
58 . The method according to claim 55 , wherein
the vascular lumen is a graft in an arteriovenous graft that joins and provides a blood flow between an artery and a vein, and the vascular fitment is positioned at the graft between the artery and the vein.
59 . The method according to claim 55 , wherein
the vascular fitment is positioned on the vascular lumen proximate to an anastomosis that provides a blood flow connection between an artery and a vein, with the vascular fitment oriented on the vascular lumen such that the first end of the protective frame is closer to the anastomosis and the second end of the protective frame is further from the anastomosis.
60 . The method according to claim 55 , wherein
the blood flow regulator is secured under the skin, in the subcutaneous region.
61 . A method for controlling blood flow through a vascular lumen comprising:
utilizing a blood flow regulator according to claim 1 with the vascular fitment positioned at a vascular lumen.
62 . The method according to claim 61 , further comprising:
actuating the fluid controller to adjust the flow restrictor between the first state that yields a relatively increased blood flow rate and the second state that yields a relatively decreased blood flow rate.
63 . The method according to claim 62 , wherein:
the flow restrictor comprises an inflatable body adapted for adjustment between the first state corresponding with a deflated state and the second state corresponding with an inflated state, and
actuating the fluid controller comprises at least one of:
actuating a fluid circuit to discharge a fluid flow from a fluid reservoir to the inflatable body for inflating the inflatable body to constrict the vascular lumen for reducing a blood flow rate, and
actuating a fluid circuit to return a fluid flow from the inflatable body to a fluid reservoir for deflating the inflatable body to distend the vascular lumen for increasing a blood flow rate.
64 . The method according to claim 63 , wherein
actuating the fluid circuit to discharge a fluid flow from the fluid reservoir to the inflatable body for inflating the inflatable body comprises multiple actuations for discharging multiple discrete fluid flows from the fluid reservoir to the inflatable body in discrete volumes for incremental inflation of the inflatable body, and
actuating the fluid circuit to return a fluid flow from the inflatable body to the fluid reservoir comprises a single actuation for returning substantially all fluid stored in the inflatable body to the fluid reservoir.