Source: https://patents.google.com/patent/US20050148925A1/en
Timestamp: 2020-01-27 14:48:46
Document Index: 762809810

Matched Legal Cases: ['Application No. 60', 'Application No. 60', 'art.\n8', 'art.\n9', 'art.\n14', 'art.\n24']

US20050148925A1 - Device and method for controlling in-vivo pressure - Google Patents
Device and method for controlling in-vivo pressure Download PDF
US20050148925A1
US20050148925A1 US11/048,807 US4880705A US2005148925A1 US 20050148925 A1 US20050148925 A1 US 20050148925A1 US 4880705 A US4880705 A US 4880705A US 2005148925 A1 US2005148925 A1 US 2005148925A1
US11/048,807
Avraham Abazakay
2001-04-20 Priority to US09/839,643 priority Critical patent/US8091556B2/en
2004-02-03 Priority to US54126704P priority
2004-05-24 Priority to US57337804P priority
2005-02-03 Application filed by Atria Medical Inc filed Critical Atria Medical Inc
2005-02-03 Priority to US11/048,807 priority patent/US20050148925A1/en
2005-03-29 Assigned to ATRIA MEDICAL INC reassignment ATRIA MEDICAL INC ASSIGNMENT OF ASSIGNORS INTEREST (SEE DOCUMENT FOR DETAILS). Assignors: ABA ZAKAY, AVRAHAM, KEREN, GAD, ROTTENBERG, DAN, ROZY, YORAM, SHMULEWITZ, ASCHER, BRAUN, ORI
2005-07-07 Publication of US20050148925A1 publication Critical patent/US20050148925A1/en
238000001727 in vivo Methods 0 abstract claims description title 7
230000033228 biological regulation Effects 0 abstract claims description 38
230000001105 regulatory Effects 0 abstract claims description 38
210000002837 Heart Atria Anatomy 0 claims description 142
230000017531 blood circulation Effects 0 description 25
210000003157 Atrial Septum Anatomy 0 description 5
230000023555 blood coagulation Effects 0 description 5
208000000059 Dyspnea Diseases 0 description 3
238000002054 transplantation Methods 0 description 3
-1 reduced longevity Diseases 0 description 2
A differential pressure regulating device is provided for controlling in-vivo pressure in a body, and in particular in a heart. The device may include a shunt being positioned between two or more lumens in a body, to enable fluids to flow between the lumens, and an adjustable flow regulation mechanism being configured to selectively cover an opening of the shunt, to regulate the flow of fluid through the shunt in relation to a pressure difference between the body lumens. In some embodiments a control mechanism coupled to the adjustable flow regulation may be provided, to remotely activate the adjustable flow regulation mechanism.
The present application is a CIP (Continuation In Part) of prior U.S. patent application Ser. No. 09/839,643, filed 20 Apr. 2001, entitled “Method and apparatus for reducing localized circulatory system pressure”, which is incorporated in its entirety herein by reference.
This application claims priority from U.S. Provisional Patent Application No. 60/541,267, filed 3 Feb. 2004, entitled “Device for reducing blood pressure in heart chamber”, and from U.S. Provisional Patent Application No. 60/573,378, filed 24 May 2004, entitled “Device and method for controlling blood flow”, which are incorporated in their entirety herein by reference.
DPRD 101 may include, for example, an adjustable shunt, tube or pathway 107 to enable fluids to flow between two body lumens, organs, regions or zones etc., for example between a left atrium 102 and a right atrium 103. DPRD 101 may include a Flow Regulation Mechanism (FRM) 108 as described herein, for example a flow valve, cover, valve opening, valve stem, or lid, to enable selected modification of the parameters of shunt 107, for example, by changing the cross section of the opening of shunt 107 or the shunt's shape etc., thereby regulating the blood flow from left atrium 102 to right atrium 103. In some embodiments FRM 108 may be set in a continually ajar position to enable a continual flow of blood between the left atrium and the right atrium. For example, FRM 108 may be purposefully left ajar, to enable a selected quantity of blood to continually flow between the heart chambers. FRM 108 may be subsequently adjusted, for example, by selectively changing the size or shape of the opening, amount of blood allowed to flow through, etc., to enable the area around the opening of shunt 107 and FRM 108 to be limited and/or expanded, thereby affecting effective flow-through of shunt 107, and enabling the quantity of blood flow between the chambers to be controlled. DPRD 101 may include one or more control mechanisms 110, for example, wires, springs, cords etc. to enable FRM 108 to be passively and/or actively controlled. In one embodiment springs may be used to enable FRM 108 to act in accordance with changes in differential pressure, for example, by being pre-loaded with a selected tension, to respond in a controlled way to changes in one or more pressure thresholds.
FRM 108 may be configured to respond to selective pressure profiles, thereby providing a known pressure relief profile. For example, FRM 108 may be preset, pre-calibrated and/or pre-configured to change its setting, adjust its configuration or position, and/or change the orifice width or flow amount etc., in accordance with changes in pressure difference between the left and right atriums of the heart. FRM 108 may be continually adjustable, for example to a continuously variable setting, for example in response to environmental conditions and/or external controls. In at least these ways, DPRD 101 may provide a selected, predictable and/or guaranteed flow of fluid between two or more bodily lumens or regions etc. In some embodiments the resting or default setting, opening size, flow level or position of FRM 108 may be changed, for example, according to pre-programmed parameters and/or remote control mechanisms. In some embodiments a continuously open or ajar FRM 108 may help prevent occlusion of shunt 107.
In other embodiments FRM 108 may include a cover, lid or other suitable mechanism that may have various forms to enable partial or total closure of FRM 108. Reference is now made to FIGS. 1B-1G. In FIG. 1B FRM 108 may include two or more arms 120 which may be configured to be continuously or constantly ajar at opening 125 of shunt 122. For example, FRM 108 may be configured to remain continually at least partially detached from shunt 107, to allow a continuous flow of fluid between left atrium 102 and right atrium 103. Arms 120 may be further opened and/or closed in response to changes in pressure differences between the heart chambers. Arms 120 may be constructed from a flexible polymer or other suitable materials. Arms 120 may have rounded shapes at arm ends 130, for example, to help prevent blood stagnation.
In FIG. 1F FRM 108 may include a shunt 122, and a cap, valve opening, valve stem, or other flow regulation mechanism 175, which may be configured to be constantly ajar at opening 125 to enable a continuous blood flow through shunt 122. Cap 175 may be coupled to a spring 177 or other suitable pressure sensitive mechanism. In one embodiment spring 177 may be pre-loaded with a selected tension to respond in a controlled way to changes in one or more pressure thresholds. FRM 108 may include one or more cap motion limiters 179. FRM 108 may include a fixed polarized magnet 181 and an electromagnetic coil 183 that includes one or more conductors 185. Cap 175 may be opened and/or closed in response to changes in pressure differences between the heart chambers and/or by remotely activating magnet 181 and/or magnetic coil 183. For example, when magnet 181 is activated cap 175 may be further opened, and when coil 183 is activated cap 175 may be further closed.
Locking mechanism 1380 may enable cover 1377 to be remotely set in one or more positions. Locking mechanism 1380 may include, for example, one or more of a spring, latch, lever, notch, slot, hook, slide or other suitable locking mechanism(s). For example, position #1 may be a lower position, for example where the hook 1325 fastens onto the catching mechanism 1332 as indicated; position #2 may be a medium position, for example where the hook 1325 fastens onto the catching mechanism 1333; position #3 may be a higher position for example where the hook 1325 fastens onto the catching mechanism 1334. Other settings, opening sizes, flow levels, positions and numbers of positions may be used. Control mechanism 1310 may include security features, for example, to help prevent unauthorized personnel from activating DPRD 1300 (e.g., special tools and magnets, coded sequence, password etc).
The dilator and wire may subsequently be withdrawn from the sheath that may now extend from the femoral vein access point in the patient's groin to the left atrium, traversing the femoral vein, the illiac vein, the inferior vena cava, the right atrium, and the atrial septum etc. The delivery catheter may be passed through the sheath while under fluoroscopic visualization Radiopaque markers may be provided on this catheter as well as the sheath in order to locate specific points. The delivery catheter may be carefully and slowly advanced so that the most distal portion of the left-atrial fixation element is emitted from the distal opening of the catheter and into the chamber of the left atrium. The fixation elements may be formed from a spring-like material and/or may be a super-elastic of shape-memory alloy, so that as it leaves the constraint provided by the inner area of the delivery catheter, it reforms into its pre-configured fully formed shape. The assembly of the sheath and the delivery catheter may then slowly be retracted en bloc so as to withdraw the fixation elements towards the atrial septum. The physician may stop this retraction when it becomes apparent by fluoroscopic visualization as well as by tactile feedback that the fixation element has become seated against the atrial septum. At that point, the sheath alone may be retracted, uncovering the shunt and positioning it within the opening that has been created within the atrial septum. The sheath may then be further retracted, allowing the right-atrial fixation element to reform into its fully formed shape. The entire shunt assembly or DPRD may then be detached from the delivery catheter system. The DPRD may be controlled within the delivery catheter by means of long controller wire that has independent translational control within the catheter area. This attachment may be formed by any conventional method, e.g., a solder or adhesive or the like that may mechanically detach at a prescribed tension level, that level being exceeded by the physician at this point in the procedure by firmly retracting the controller wire. Other methods of deployment of DPRD and/or FRM may be used.
At block 140 a DPRD may be implanted between two or more chambers, lumens, organs, regions, zones etc. in a body, for example, using a catheter. At block 141 a FRM may be deployed in a selected setting or position, for example, to enable a continuous flow of fluid between two or more lumens, and to be selectively activated or de-activated in accordance with changes in pressure differences between the lumens. At block 142 the FRM may be controlled (e.g., passively) in response to changes in pressure differences between the lumens, for example, FRM may be further opened and/or closed in response to a pressure change. Optionally, at block 143 the DPRD and/or FRM may be remotely controlled to help control the flow of fluids between the lumens. In some embodiments the remote control of the DRPD and/or FRM may enable cleaning the DPRD and/or FRM, disabling the DRPD and/or FRM, changing elements of the DPRD and/or FRM etc. Any combination of the above steps may be implemented. Further, other steps or series of steps may be used.
The foregoing description of the embodiments of the invention has been presented for the purposes if illustration and description. It is not intended to be exhaustive or to limit the invention to the precise form disclosed. It should be appreciated by persons skilled in the art that many modifications, variations, substitutions, changes, and equivalents are possible in the light of the above teaching. It is therefore, to be understood that the appended claims are intended to cover all such modifications and changes as fall within the true spirit of the invention.
a shunt being positioned between two or more lumens in a body, to enable fluids to flow between said lumens; and
an adjustable flow regulating mechanism, being configured to selectively cover an opening of said shunt, to regulate the flow of fluid through said shunt in relation to a pressure difference between said body lumens.
2. The pressure regulating device of claim 1, wherein said flow regulating mechanism is to allow a continuous flow of fluids between said body lumens.
3. The pressure regulating device of claim 1, wherein said flow regulating mechanism is to be continually adjustable in accordance with at least one pressure threshold.
4. The pressure regulating device of claim 1, wherein said flow regulating mechanism is to be continually adjustable in accordance with changes in pressure difference between said lumens.
5. The pressure regulating device of claim 1, comprising a control mechanism to remotely control said flow regulating mechanism.
7. The pressure regulating device of claim 1, wherein said body lumens are chambers of the heart.
8. The pressure regulating device of claim 1, wherein said shunt is to be positioned in the septum of the heart, between the left atrium of the heart and right atrium of the heart.
9. The pressure regulating device of claim 1, wherein said flow regulating mechanism is to close the opening of said shunt.
10. The pressure regulating device of claim 1, wherein said flow regulating mechanism includes one or more mechanisms selected from the group consisting of a disk valve connected to a twisting spring, a pre-shaped flexible wire, a cone connected to a compression spring, a leaflet valve, a flexible disk having an adjustable, substantially central hole, a first balloon having liquid therein and connected through a tube to a second balloon, a first balloon having liquid therein and connected through a tube to a reservoir having a piston moving against a compression spring, and a first balloon having liquid therein and connected through a tube to a reservoir having a piston moving in accordance with a controlled activation system.
11. A differential pressure regulating device, the device comprising:
a shunt being positioned between two or more chambers in a heart, to enable fluids to flow between said chambers;
an adjustable flow regulating mechanism, being configured to selectively cover the opening of said shunt, to regulate the flow of fluid through said shunt; and
a control mechanism to be coupled to said adjustable flow regulating mechanism, to remotely activate said adjustable flow regulation mechanism.
12. The pressure regulating device of claim 1 1, wherein said control mechanism includes one or more mechanisms selected from the group consisting of one or more wires, lines, springs, pins, cables, magnets, hooks, latches, electric mechanisms, pressure transducers, wireless mechanisms, telemetry mechanisms, pneumatic mechanisms, and motors.
13. The pressure regulating device of claim 11, wherein said chambers are atriums of the heart.
14. The pressure regulating device of claim 11, wherein said shunt is to be positioned in the septum, between the left and right atrium.
15. The pressure regulating device of claim 11, wherein said flow regulating mechanism is to be continually adjustable in accordance with at least one pressure threshold.
16. The pressure regulating device of claim 11, wherein said flow regulating mechanism is rigid, said flow regulating mechanism position being directly controlled by said control mechanism, thereby substantially determining the precise size of the opening of said shunt.
17. An in-vivo pressure control method, the method comprising:
implanting a differential pressure regulation device in a body, said pressure regulation device including a shunt placed between two or more lumens in a said body;
deploying a flow regulating mechanism; and
controlling said flow regulating mechanism setting according to changes in pressure differences between said lumens.
18. The pressure control method of claim 17, comprising remotely controlling said flow regulating mechanism positioning.
19. The pressure control method of claim 17, comprising reducing a pressure difference between a first lumens and a second lumens.
20. The pressure control method of claim 17, comprising positioning said flow regulation mechanism to enable a continual flow of fluid between said lumens.
21. The pressure control method of claim 17, comprising positioning said flow regulation mechanism to cease the flow of fluid between said lumens.
22. The pressure control method of claim 17, wherein said implanting is implemented using percutaneous delivery.
23. An in-vivo pressure control method, the method comprising remotely controlling a flow regulation mechanism flow setting using a control mechanism implanted in a body, said flow regulation mechanism disposed within a differential pressure regulation device comprising a shunt placed between a left atrium of a heart and a right atrium of a heart.
24. The pressure control method of claim 23, comprising reducing a pressure difference between a left and right atrium using said flow regulation mechanism.
25. The method of claim 23, wherein said control mechanism is positioned under the skin of a patient.
26. The method of claim 23, wherein said control mechanism is accessed using one or more mechanisms selected from the group consisting of: wires, lines, springs, pins, cables, magnets, latches, electric mechanisms, pressure transducers, wireless mechanisms, pneumatic mechanisms, and motors.
27. The method of claim 24, wherein said reduction of blood pressure is to reduce left ventricle blood pressure.
US11/048,807 2001-04-20 2005-02-03 Device and method for controlling in-vivo pressure Abandoned US20050148925A1 (en)
US09/839,643 US8091556B2 (en) 2001-04-20 2001-04-20 Methods and apparatus for reducing localized circulatory system pressure
US54126704P true 2004-02-03 2004-02-03
US57337804P true 2004-05-24 2004-05-24
US11/048,807 US20050148925A1 (en) 2001-04-20 2005-02-03 Device and method for controlling in-vivo pressure
US09/839,643 Continuation-In-Part US8091556B2 (en) 2001-04-20 2001-04-20 Methods and apparatus for reducing localized circulatory system pressure
US20050148925A1 true US20050148925A1 (en) 2005-07-07
US10/597,666 Active US8070708B2 (en) 2004-02-03 2005-02-03 Device and method for controlling in-vivo pressure
US11/048,807 Abandoned US20050148925A1 (en) 2001-04-20 2005-02-03 Device and method for controlling in-vivo pressure
US10/597,666 Granted US20070282157A1 (en) 2004-02-03 2005-03-02 Device And Method For Controlling In-Vivo Pressure
US13/108,672 Active 2026-04-07 US9724499B2 (en) 2001-04-20 2011-05-16 Device and method for controlling in-vivo pressure
US13/108,698 Abandoned US20110218480A1 (en) 2001-04-20 2011-05-16 Device and method for controlling in-vivo pressure
US13/108,850 Abandoned US20110218481A1 (en) 2001-04-20 2011-05-16 Device and method for controlling in-vivo pressure
US14/154,093 Abandoned US20140163449A1 (en) 2001-04-20 2014-01-13 Device and method for controlling in-vivo pressure
US15/668,622 Active 2025-03-24 US10463490B2 (en) 2001-04-20 2017-08-03 Device and method for controlling in-vivo pressure
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2005-02-03 CN CN201510226589.1A patent/CN104971390B/en active IP Right Grant
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Owner name: ATRIA MEDICAL INC, ISRAEL
Free format text: ASSIGNMENT OF ASSIGNORS INTEREST;ASSIGNORS:ROTTENBERG, DAN;BRAUN, ORI;ABA ZAKAY, AVRAHAM;AND OTHERS;REEL/FRAME:015832/0984;SIGNING DATES FROM 20050102 TO 20050202