Remote sensing gene therapy delivery device and method of administering a therapeutic solution to a heart
First Claim
1. A device for delivering a therapeutic solution from a solution supply into cardiac tissue, the device comprising:
- a hollow needle having a needle proximal end and a needle distal end, said needle proximal end being adapted for fluid attachment to said solution supply, said needle comprising an elongated flexible body, and a sharpened tip disposed at said needle distal end for penetration of cardiac tissue, a steering cable having a cable distal end secured to the hollow needle at a coupling, said coupling being spaced from the distal end of the hollow needle, said steering cable extending toward the proximal end of the hollow needle and having a cable proximal end, said steering cable being manipulable to flex the needle distal end relative to the needle proximal end along a flexion radius when a tensioning force is applied to the cable proximal end, and a steering sleeve movable disposed about the elongated flexible body and said steering cable such that a distance between the steering sleeve and said coupling determines the flexion radius and whereby movement of the steering sleeve along the hollow needle adjust the flexion radius.
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Accused Products
Abstract
The invention provides a steerable device for the delivery of a therapeutic solution, in particular, an angiogenesis-promoting substance into a heart, and a method of delivering such a substance into the heart. The device includes an elongated needle which the physician may steer by asserting a tensioning force on a steering cable coupled to the needle toward its distal end. A axially-slidable steering sleeve is disposed about the needle and the steering cable, and the position of the steering sleeve may be adjusted to control the radius of flexure of the needle. The needle body is flexible enough to maneuver around thoracic and cardiac geometry, yet sufficiently rigid to facilitate such maneuvering. The needle may also have a stop, or platform, spaced from the distal needle tip to stabilize the needle in the cardiac tissue. According to a method of the invention, the needle may be inserted into the heart tissue through lung tissue adhering to the heart, as is common in re-operative patients. The platform may either transit the needle as the platform contacts the lung or heart tissue, or the platform may move forward to contact tissue as needle contact with heart tissue is confirmed.
241 Citations
40 Claims
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1. A device for delivering a therapeutic solution from a solution supply into cardiac tissue, the device comprising:
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a hollow needle having a needle proximal end and a needle distal end, said needle proximal end being adapted for fluid attachment to said solution supply, said needle comprising an elongated flexible body, and a sharpened tip disposed at said needle distal end for penetration of cardiac tissue, a steering cable having a cable distal end secured to the hollow needle at a coupling, said coupling being spaced from the distal end of the hollow needle, said steering cable extending toward the proximal end of the hollow needle and having a cable proximal end, said steering cable being manipulable to flex the needle distal end relative to the needle proximal end along a flexion radius when a tensioning force is applied to the cable proximal end, and a steering sleeve movable disposed about the elongated flexible body and said steering cable such that a distance between the steering sleeve and said coupling determines the flexion radius and whereby movement of the steering sleeve along the hollow needle adjust the flexion radius. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11)
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12. A device for delivering a therapeutic solution from a solution supply into target tissue, the device comprising:
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a hollow needle having a needle proximal end and a needle distal end, said needle proximal end being adapted for fluid attachment to said solution supply, said needle comprising an elongated flexible body, a sharpened tip disposed at said needle distal end for penetration of target tissue, and a platform moveably disposed along the needle body and spaced from the needle distal end, said platform acting to stabilize the needle relative to the target tissue during delivery of the therapeutic solution. - View Dependent Claims (13, 14, 15, 16, 17, 18, 19, 20, 21, 22)
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23. A method of delivering a therapeutic substance to heart tissue of a patient, the method comprising:
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inserting a delivery device into the patient'"'"'s thoracic cavity through an opening in the patient'"'"'s chest wall, said delivery device having a needle for injecting the therapeutic substance into the heart tissue, passing the needle through the patient'"'"'s lung tissue and into the heart tissue, and delivering the therapeutic substance to the patient'"'"'s heart. - View Dependent Claims (24, 25, 26, 27, 28, 29, 30, 31, 32, 33)
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34. A method of delivering a therapeutic substance to heart tissue of a patient, the method comprising:
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inserting a delivery device into the patient'"'"'s thoracic cavity through an opening in the patient'"'"'s chest wall, said delivery device having a needle for injecting the therapeutic substance into the heart tissue, exerting a force on the proximal end of a steering cable, the distal end of the steering cable being coupled to the needle toward the needle distal end to steer the needle distal end along a flexion radius, adjusting the flexion radius by moving a steering sleeve disposed about the needle and the steering cable axially along the needle, the steering cable extending through the steering sleeve such that the proximal end of the steering sleeve is accessible to the user, passing the needle into the heart tissue, and delivering the therapeutic substance to the patient'"'"'s heart. - View Dependent Claims (35)
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36. A method of delivering a therapeutic substance to heart tissue of a patient, the method comprising:
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inserting a delivery device into the patient'"'"'s body cavity through an opening, said delivery device having a needle for injecting the therapeutic substance into the tissue, contacting a sharpened tip of the needle with the heart tissue, penetrating the heart tissue with the sharpened tip, contacting a platform disposed about the needle with body tissue, moving the platform axially relative to the needle, delivering the therapeutic substance to the patient'"'"'s heart. - View Dependent Claims (37, 38)
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39. A method of delivering a therapeutic substance to heart tissue of a patient, the method comprising:
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inserting a delivery device into the patient'"'"'s body cavity through an opening, said delivery device having a needle for injecting the therapeutic substance into the tissue, contacting a sharpened tip of the needle with the heart tissue, penetrating the heart tissue with the sharpened tip, inflating a platform disposed adjacent the heart tissue, delivering the therapeutic substance to the patient'"'"'s heart. - View Dependent Claims (40)
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Specification