Devices and methods for interstitial injection of biologic agents into tissue
First Claim
1. A device for injecting a medical agent into tissue, the device comprising:
- an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis;
a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region;
a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and
a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body comprises a first side and a second side and wherein the second body comprises a first side and a second side, wherein the first sides are opposite relative to the second sides, and wherein each of the first sides and each of the second sides comprise a distal arm linkage and a proximal arm linkage, wherein the distal and proximal arm linkages comprise a first linkage arm pivotally coupled to the first body and a second linkage arm pivotally coupled to both the second body and to the first linkage arm about a linkage joint, such that urging the distal linkage joints and proximal linkage joints farther apart urges the first and second bodies closer together and urging the distal and proximal linkage joints closer together urges the first and second bodies farther apart, wherein the proximal linkage joints are secured to the elongate shaft, the device further comprising a first elongate member slidably coupled to the elongate shaft and having a first elongate member distal region secured to the distal linkage joint, such that distally sliding the first elongate member relative to the elongate shaft urges the distal and proximal linkage joints further apart and the needles along their needle axes out of the second body, and such that proximally retracting the first elongate member relative to the elongate shaft urges the distal and proximal linkage joints closer together and urges the needles into the second body.
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Accused Products
Abstract
Apparatus and methods for injecting biological agents into tissue. Devices are provided having elongate shafts and distal injection heads for transversely driving needles into tissue and injecting medical agents into the tissue through the needles. A longitudinal force directed along the shaft can be translated to a needle driving force transverse to the shaft. Some devices provide controllably variable needle penetration depth. Devices include mechanical needle drivers utilizing four link pantographs, rack and pinions, and drive yokes for driving a first needle bearing body toward a second tissue contacting body. Other devices include inflatable members for driving and retracting needles. Still other devices include magnets for biasing the needles in extended and/or retracted positions. The invention includes minimally invasive methods for epicardially injecting cardiocyte precursor cells into infarct myocardial tissue.
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Citations
30 Claims
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1. A device for injecting a medical agent into tissue, the device comprising:
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an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis; a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region; a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body comprises a first side and a second side and wherein the second body comprises a first side and a second side, wherein the first sides are opposite relative to the second sides, and wherein each of the first sides and each of the second sides comprise a distal arm linkage and a proximal arm linkage, wherein the distal and proximal arm linkages comprise a first linkage arm pivotally coupled to the first body and a second linkage arm pivotally coupled to both the second body and to the first linkage arm about a linkage joint, such that urging the distal linkage joints and proximal linkage joints farther apart urges the first and second bodies closer together and urging the distal and proximal linkage joints closer together urges the first and second bodies farther apart, wherein the proximal linkage joints are secured to the elongate shaft, the device further comprising a first elongate member slidably coupled to the elongate shaft and having a first elongate member distal region secured to the distal linkage joint, such that distally sliding the first elongate member relative to the elongate shaft urges the distal and proximal linkage joints further apart and the needles along their needle axes out of the second body, and such that proximally retracting the first elongate member relative to the elongate shaft urges the distal and proximal linkage joints closer together and urges the needles into the second body. - View Dependent Claims (2, 3)
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4. A device for injecting a medical agent into tissue, the device comprising:
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an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis; a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region; a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the second body comprises a rack fixedly coupled to the second body, and wherein the device further comprises a pinion rotatably coupled to the first body and having teeth engaging the rack such that rotating the pinion in a first direction urges the first and second bodies closer together and rotating the pinion in a second direction urges the first and second bodies farther apart. - View Dependent Claims (5)
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6. A device for injecting a medical agent into tissue, the device comprising:
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an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis; a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region; a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first and second bodies comprise a first expandable member disposed therebetween such that expanding the first expandable member urges the first and second bodies apart and retracts the needles toward the second body. - View Dependent Claims (7, 8, 9, 10)
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11. A device for injecting a medical agent into tissue, the device comprising:
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an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis; a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region; a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body comprises a first magnet, and the second body comprises a second magnet, and wherein the magnets are disposed opposite each other such that the first and second bodies are magnetically biased apart. - View Dependent Claims (12)
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13. A device for injecting a medical agent into tissue, the device comprising:
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an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis; a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region; a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body comprises a first magnet and the second body comprises a second magnet, wherein the magnets are disposed opposite each other such that the first and second bodies are magnetically biased toward each other.
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14. A device for injecting a medical agent into tissue, the device comprising:
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an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis; a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region; a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body or the second body comprises at least one first magnet facing the body that does not comprise the first magnet, wherein the body that does not comprise the first magnet comprises a second magnet slidably disposed thereon and having an opposite polarity facing the first magnet, such that the first and second magnets have a first position wherein the first magnet attracts the second magnet, and a second position, wherein the first magnet does not attract the second magnet.
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15. A device for injecting a medical agent into tissue, the device comprising:
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an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis; a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region; a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body or the second body comprises at least one first magnet facing the body that does not comprise the first magnet, wherein the body that does not comprise the first magnet comprises a second magnet slidably disposed thereon and having the same polarity facing the first magnet, such that the first and second magnets have a first position wherein the first magnet repulses the second magnet, and a second position, wherein the first magnet does not repulse the second magnet. - View Dependent Claims (16)
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17. A device for injecting a medical agent into tissue, the device comprising:
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an elongate shaft comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis; a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region; a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the first body comprises a first magnet, the second body comprises a second magnet, and wherein one of the first and second bodies comprises a third magnet, wherein at least one of the three magnets is slidably disposed on its respective body and at least two of the three magnets are adjacent and have opposite polarities such that the three magnets have a first position wherein two of the three magnets attract the first and second body together and a second position wherein two of the three magnets repulse the first and second body apart.
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18. A device for injecting a medical agent into tissue, the device comprising:
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an elongate shall comprising a length, a longitudinal axis, a proximal region and a distal region, wherein the distal region comprises a distal region longitudinal axis; a plurality of hollow needles having a sharp distal end, at least one discharge port, a length, and a needle axis along the needle length, wherein the needles are operably coupled to the elongate shaft distal region such that needle axes are substantially perpendicular to the elongate shaft distal region; a needle driver coupled to the elongate shaft configured to drive the needles substantially perpendicular to the distal region longitudinal axis and into the tissue; and a discharger configured to discharge the agent from the needle discharge ports, wherein the needle driver comprises a first body having the needles fixedly attached thereto and a second body having the needles slidably disposed therethrough, wherein the second body comprises at least one sensor. - View Dependent Claims (19, 20, 21)
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22. A device for injecting a medical substance into tissue, the device comprising:
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a first body comprising a plurality of hollow needles and a first plurality of magnets; a second body having the plurality of needles slidably received therethrough; a third body comprising a second plurality of magnets, wherein the third body is slidably disposed on the second body;
wherein the first and second plurality of magnets are disposed and have polarities oriented such that the slidable third body has a first position in which the first and third body are magnetically attracted to each other and a second position in which the first and third body are magnetically repulsed from each other, such that sliding the third member can act to pull the first body toward the second body and can also act to push the first body away from the second body. - View Dependent Claims (23)
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24. A device for injecting a medical substance into tissue, the device comprising:
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a first body having a plurality of hollow needles attached thereto; a second body having the plurality of needles slidably received therethrough, wherein the second body includes a rack fixedly coupled to the second body, the device further comprising a pinion rotatably coupled to the first body and having teeth engaging the rack such that rotating the pinion in a first direction urges the first and second bodies closer together and rotating the pinion in a second direction urges the first and second bodies farther apart. - View Dependent Claims (25)
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26. A device for injecting a medical substance into tissue, the device comprising:
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a first body having a plurality of hollow needles attached thereto; a second body having the plurality of needles slidably received therethrough, wherein the first and second bodies have a first expandable member disposed therebetween, such that expanding the first expandable member urges the first and second bodies apart and retracts the needles toward the second body. - View Dependent Claims (27, 28, 29, 30)
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Specification