Safety valve assembly for implantable benefical agent infusion device
First Claim
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1. An implantable beneficial agent infusion device, comprising:
- an hermetically sealed enclosure;
a fluid reservoir positioned at least partially within the hermetic enclosure, the fluid reservoir having means for maintaining a fluid containing a beneficial agent disposed therewithin between a first pressure and a second pressure;
means for delivering the fluid into a patient'"'"'s body;
a controllable pump, the pump communicating with the reservoir and the means for delivering the fluid into a patient'"'"'s body and causing the fluid to move from the reservoir into the means for delivering a fluid into a patient'"'"'s body upon receiving a command actuating same; and
a safety valve assembly comprising a first substrate, a deflectable, moveable upper member having upper and lower surfaces, a compressible seal having upper and lower surfaces, a deflectable, moveable lower member having upper and lower surfaces, and means for controllably energizing and deflecting the lower member by providing an output signal thereto;
wherein the upper surface of the upper member forms a portion of the fluid reservoir and is in contact with the fluid, the fluid exerting a pressure on the upper surface of the upper member, the lower surface of the upper member engaging the top surface of the seal, the lower surface of the seal being affixed to the lower member and seatable against the first substrate, the upper surface of the seal being seatable against the lower surface of the upper member, the lower surface of the upper member being mechanically biased against the upper surface of the seal when the seal is in a closed position, the energizing and deflecting means being electrically coupled to the upper and lower surfaces of the lower member, the lower member being deflectable or moveable between a first non-energized position in which movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is blocked and the seal is in a closed position, and a second energized position in which the movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is permitted as the seal is further pushed against the lower surface of the upper member into an open position through deflection or movement of the lower member occurring in response to the output signal being provided to the lower member, the fluid moving into the means for delivering the fluid into the patient'"'"'s body and the upper member being deflected further inwardly into the fluid reservoir when the seal is pushed into the open position.
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Abstract
An implantable beneficial agent infusion device featuring a unique safety valve assembly is disclosed. In one embodiment of the present invention, a seal in the safety valve assembly is normally closed and only opens upon a deflectable or moveable member to which the seal is attached being electrically, magnetically or electromagnetically activated. The valve assembly is preferably small in size and made of corrosion resistant materials. The valve assembly may be employed in either a passive or an active implantable drug or beneficial agent infusion system.
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Citations
56 Claims
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1. An implantable beneficial agent infusion device, comprising:
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an hermetically sealed enclosure;
a fluid reservoir positioned at least partially within the hermetic enclosure, the fluid reservoir having means for maintaining a fluid containing a beneficial agent disposed therewithin between a first pressure and a second pressure;
means for delivering the fluid into a patient'"'"'s body;
a controllable pump, the pump communicating with the reservoir and the means for delivering the fluid into a patient'"'"'s body and causing the fluid to move from the reservoir into the means for delivering a fluid into a patient'"'"'s body upon receiving a command actuating same; and
a safety valve assembly comprising a first substrate, a deflectable, moveable upper member having upper and lower surfaces, a compressible seal having upper and lower surfaces, a deflectable, moveable lower member having upper and lower surfaces, and means for controllably energizing and deflecting the lower member by providing an output signal thereto;
wherein the upper surface of the upper member forms a portion of the fluid reservoir and is in contact with the fluid, the fluid exerting a pressure on the upper surface of the upper member, the lower surface of the upper member engaging the top surface of the seal, the lower surface of the seal being affixed to the lower member and seatable against the first substrate, the upper surface of the seal being seatable against the lower surface of the upper member, the lower surface of the upper member being mechanically biased against the upper surface of the seal when the seal is in a closed position, the energizing and deflecting means being electrically coupled to the upper and lower surfaces of the lower member, the lower member being deflectable or moveable between a first non-energized position in which movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is blocked and the seal is in a closed position, and a second energized position in which the movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is permitted as the seal is further pushed against the lower surface of the upper member into an open position through deflection or movement of the lower member occurring in response to the output signal being provided to the lower member, the fluid moving into the means for delivering the fluid into the patient'"'"'s body and the upper member being deflected further inwardly into the fluid reservoir when the seal is pushed into the open position. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16, 17, 18, 19, 20, 21, 22, 23, 24, 25, 26, 27, 37)
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28. An implantable means for infusing a fluid beneficial agent into a patient'"'"'s body, comprising:
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an hermetically sealed means for enclosing;
a means for containing the fluid positioned at least partially within the enclosing means, the fluid containing means having means for maintaining the fluid disposed therewithin between a first pressure and a second pressure;
means for delivering the fluid into the patient'"'"'s body;
controllable means for pumping, the pumping means communicating with the fluid containing means and the means for delivering the fluid into a patient'"'"'s body and causing the fluid to move from the fluid containing means into the means for delivering a fluid into the patient'"'"'s body upon receiving a command actuating the pumping means; and
a safety valve assembly comprising a first substrate, a first upper means for moving having upper and lower surfaces, a means for sealing having upper and lower surfaces, a second lower means for moving having upper and lower surfaces, and means for controllably energizing and deflecting the lower member by providing an output signal thereto or thereacross;
wherein the upper surface of the upper moving means forms a portion of the fluid containing means and is in contact with the fluid, the fluid exerting a pressure on the upper surface of the upper moving means, the lower surface of the upper moving means engaging the top surface of the sealing means, the lower surface of the sealing means being affixed to the lower moving means and seatable against the first substrate, the upper surface of the sealing means being seatable against the lower surface of the upper moving means, the lower surface of the upper moving means being mechanically biased against the upper surface of the sealing means when the sealing means is in a closed position, the energizing and deflecting means being electrically coupled to the upper and lower surfaces of the lower moving means, the lower moving means being deflectable or moveable between a first non-energized position in which movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is blocked when the sealing means is in a closed position, and a second energized position in which the movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is permitted as the sealing means is further pushed against the lower surface of the upper moving means into an open position through deflection or movement of the lower moving means occurring in response to the output signal being provided to the lower moving means, the fluid moving into the means for delivering the fluid into the patient'"'"'s body and the upper moving means being deflected further inwardly into the fluid containing means when the sealing means is pushed into the open position. - View Dependent Claims (29, 30, 31, 32, 33, 34, 35, 36, 38, 39, 40, 41, 42, 43, 44, 45, 46, 47, 48, 49, 50, 51, 52, 53, 54)
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55. A method of making an implantable beneficial agent infusion device, the device comprising an hermetic enclosure, a fluid reservoir positioned at least partially within the hermetic enclosure, the fluid reservoir having means for maintaining a fluid containing a beneficial agent disposed therewithin between a first pressure and a second pressure, means for delivering the fluid into a patient'"'"'s body, a controllable pump, the pump communicating with the reservoir and the means for delivering the fluid into a patient'"'"'s body and causing the fluid to move from the reservoir into the means for delivering a fluid into a patient'"'"'s body upon receiving a command actuating same, and a safety valve assembly comprising a first substrate, a deflectable, moveable upper member having upper and lower surfaces, a compressible seal having upper and lower surfaces, a deflectable, moveable lower member having upper and lower surfaces, and means for controllably energizing and deflecting the lower member by providing an output signal thereto, wherein the upper surface of the upper member forms a portion of the fluid reservoir and is in contact with the fluid, the fluid exerting a pressure on the upper surface of the upper member, the lower surface of the upper member engaging the top surface of the seal, the lower surface of the seal being affixed to the lower member and seatable against the first substrate, the upper surface of the seal being seatable against the lower surface of the upper member, the lower surface of the upper member being mechanically biased against the upper surface of the seal when the seal is in a closed position, the energizing and deflecting means being electrically coupled to the upper and lower surfaces of the lower member, the lower member being deflectable or moveable between a first non-energized position in which movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is blocked and the seal is in a closed position, and a second energized position in which the movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is permitted as the seal is further pushed against the lower surface of the upper member into an open position through deflection or movement of the lower member occurring in response to the output signal being provided to the lower member, the fluid moving into the means for delivering the fluid into the patient'"'"'s body and the upper member being deflected further inwardly into the fluid reservoir when the seal is pushed into the open position, the method comprising:
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(a) providing the hermetically sealed enclosure;
(b) providing the fluid reservoir;
(c) providing the means for delivering the fluid into the patient'"'"'s body;
(d) providing the pump;
(e) providing the safety valve assembly, and (f) operatively connecting the hermetically sealed enclosure, the fluid reservoir, the means for delivering the fluid into the patient'"'"'s body, the pump and the safety valve assembly to one another.
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56. A method of infusing a beneficial agent or drug into a patient with an implantable beneficial agent infusion device, the device comprising an hermetic enclosure, a fluid reservoir positioned at least partially within the hermetic enclosure, the fluid reservoir having means for maintaining a fluid containing a beneficial agent disposed therewithin between a first pressure and a second pressure, means for delivering the fluid into a patient'"'"'s body, a controllable pump, the pump communicating with the reservoir and the means for delivering the fluid into a patient'"'"'s body and causing the fluid to move from the reservoir into the means for delivering a fluid into a patient'"'"'s body upon receiving a command actuating same, and a safety valve assembly comprising a first substrate, a deflectable, moveable upper member having upper and lower surfaces, a compressible seal having upper and lower surfaces, a deflectable, moveable lower member having upper and lower surfaces, and means for controllably energizing and deflecting the lower member by providing an output signal thereto, wherein the upper surface of the upper member forms a portion of the fluid reservoir and is in contact with the fluid, the fluid exerting a pressure on the upper surface of the upper member, the lower surface of the upper member engaging the top surface of the seal, the lower surface of the seal being affixed to the lower member and seatable against the first substrate, the upper surface of the seal being seatable against the lower surface of the upper member, the lower surface of the upper member being mechanically biased against the upper surface of the seal when the seal is in a closed position, the energizing and deflecting means being electrically coupled to the upper and lower surfaces of the lower member, the lower member being deflectable or moveable between a first non-energized position in which movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is blocked and the seal is in a closed position, and a second energized position in which the movement of the fluid from the reservoir into the means for delivering the fluid into the patient'"'"'s body is permitted as the seal is further pushed against the lower surface of the upper member into an open position through deflection or movement of the lower member occurring in response to the output signal being provided to the lower member, the fluid moving into the means for delivering the fluid into the patient'"'"'s body and the upper member being deflected further inwardly into the fluid reservoir when the seal is pushed into the open position, the method comprising:
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(a) energizing the lower member and causing same to move;
(b) moving the seal into the open position in response to the lower member being energized and moving, and (c) causing at least a portion of the fluid contained in the reservoir to flow into the means for delivering the fluid into the patient'"'"'s body.
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Specification