Apparatus and method for delivering therapeutic and diagnostic agents
First Claim
Patent Images
1. A drug-delivery tool for delivering a drug to body tissue, such as a heart-wall, comprising:
- (a) an accessing device having distal and proximal ends, an inner lumen extending therebetween, a drug-delivery reservoir adapted to hold such drug, and a user-control structure at the accessing device'"'"'s proximal end, (b) a tissue-penetrating implement carried at the accessing device'"'"'s distal end for axial movement into and out of the lumen, the implement having first and second expandable members which are disposed in a substantially co-extension condition, when the implement is disposed in a retracted condition within the lumen, and an expanded, spaced-apart condition when the implement is advanced to an extended condition out of the lumen, at least one of the members having a tip for penetrating such tissue (c) a first operative connection between the control structure and the implement which is operable, upon user activation of the control structure, to advance the implement from its retracted to its extended condition, wherein, when the accessing device'"'"'s distal end is placed against a surface region of the tissue, the implement is advanced into the tissue, causing the two expandable members to expand to form a cavity within the tissue, and (d) a second operative connection between the control structure and the reservoir which is operable, upon user activation of the control structure, to deliver drug from the reservoir into such cavity.
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Abstract
A drug-delivery tool and method for delivering a diagnostic or therapeutic agent to a target site within a selected body tissue, such as the myocardium of the heart, is disclosed. The drug-delivery tool generally includes an accessing device having a tissue-penetrating implement in its distal-end region, and elements for delivering a selected agent into a cavity formed by the implement.
247 Citations
38 Claims
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1. A drug-delivery tool for delivering a drug to body tissue, such as a heart-wall, comprising:
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(a) an accessing device having distal and proximal ends, an inner lumen extending therebetween, a drug-delivery reservoir adapted to hold such drug, and a user-control structure at the accessing device'"'"'s proximal end, (b) a tissue-penetrating implement carried at the accessing device'"'"'s distal end for axial movement into and out of the lumen, the implement having first and second expandable members which are disposed in a substantially co-extension condition, when the implement is disposed in a retracted condition within the lumen, and an expanded, spaced-apart condition when the implement is advanced to an extended condition out of the lumen, at least one of the members having a tip for penetrating such tissue (c) a first operative connection between the control structure and the implement which is operable, upon user activation of the control structure, to advance the implement from its retracted to its extended condition, wherein, when the accessing device'"'"'s distal end is placed against a surface region of the tissue, the implement is advanced into the tissue, causing the two expandable members to expand to form a cavity within the tissue, and (d) a second operative connection between the control structure and the reservoir which is operable, upon user activation of the control structure, to deliver drug from the reservoir into such cavity. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 36)
(i) a pull-wire assembly extending longitudinally through the catheter accessing device, the pull-wire assembly being operable to deflect the distal end of the accessing device substantially within a plane; and
(ii) one or more force contact transducers mounted at the distal end of the accessing device within the deflection plane.
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5. The tool of claim 4, further comprising one or more additional force contact transducers mounted at the distal end of the accessing device outside of the deflection plane.
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6. The tool of claim 1, wherein the accessing device is incorporated in an endoscope assembly.
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7. The tool of claim 1, wherein the tissue-penetrating implement includes
(i) a cutting or slicing tip on the first expandable member; - and
(ii) one or more resiliently flexible second expandable members being adapted to expand radially outward in their normal state.
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8. The tool of claim 1, wherein a drug-delivery passage is formed by an elongate conduit having an internal lumen that extends between the tissue-penetrating implement and drug-delivery reservoir;
- the conduit being adapted for sliding movement within the accessing device, coupled with movement of the tissue-penetrating implement.
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9. The tool of claim 8, for use in delivering a selected drug having a net negative charge, further comprising first and second electrodes adapted to be placed in electrical communication with a power supply, with the first electrode being disposed at a distal region of the tissue-penetrating implement and the decond electrode being disposed proximally of the tissue-penetrating implement;
- wherein generation of a positive charge at the first terminal is effective to draw at least a member of the negatively charge species from the drug-delivery passage into the expandable members of the tissue-penetrating implement.
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10. The tool of claim 1, for use with solid or semi-solid agents, wherein the second expandable member of the tissue-penetrating implement comprises a plurality of resiliently flexible expandable members disposed at spaced positions about the longitudinal axis of the tool so as to define a cage or skeleton capable of holding such an agent as it is placed in a cavity formed by the implement.
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11. The tool of claim 1, wherein at least one of the expandable members has a tissue-penetrating tip, and at least one of the expandable members has a cutting tip for slicing tissue in the direction of expansion of the implement members, wherein when the implement is being advanced into such tissue, from its retracted to its extended condition, the implement forms a drug-receiving pocket in the tissue.
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12. The tool of claim 1, 2, 3, 4, or 5, wherein the first expandable member further comprises construction from a shape memory material capable of a first remembered curved shape, and a second, stress induced linear shape causing the first expandable member to cut in an arc shape as it is advanced through a tissue.
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13. The tool of claims 1, 2, 4, or 5, wherein the second expandable member comprises a ribbed balloon, wherein each rib defines a lumen in communication with the drug-delivery reservoir, and each rib further defines a plurality of exit ports from the rib lumen that the drug may perfuse through.
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14. The tool of claims 1, 2, 4, or 5, wherein the first expandable member is a cork-screw shaped tubular member defining a lumen in communication with the drug-delivery reservoir, wherein the first expandable member is rotatable along its axis to permit it to screw into a tissue upon axial rotation.
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36. The tool of claim 1, wherein the accessing device is incorporated in an open surgical assembly.
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15. A method for delivering a selected diagnostic or therapeutic agent to a target site within a selected body tissue, comprising:
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(i) forming a cut or slice extending from a wall of the selected tissue to the target site;
(ii) moving the tissue bordering the cut or slice radially outward, thereby forming a cavity within the tissue at the target site;
(iii) delivering a selected agent into the cavity; and
(iv) permitting the cavity to collapse once a selected amount of the agent has been delivered therein. - View Dependent Claims (16, 17, 18, 19, 20, 21, 22, 23)
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24. An drug-delivery tool for delivering a selected diagnostic or therapeutic agent to a target site within a selected body tissue, comprising:
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an accessing device having proximal and distal ends, with a lumen extending between said ends and terminating at an orifice at said distal end;
a tissue-penetrating implement movable between a retracted condition, within a distal region of said lumen, and an extended condition, extending out of said orifice;
wherein said implement includes (i) a tip configured to penetrate a selected body tissue when the distal end of the accessing device is placed there against and the implement is moved from its retracted condition to its extended condition, and (ii) an expandable member disposed proximal of said tip for following the tip to a target site within such tissue, and adapted to expand radially, with the implement at its extended condition, with sufficient force to form a cavity at the target site by pressing the tissue at the target site away from the longitudinal axis of the implement; and
an agent-delivery passage disposed longitudinally between the proximal and distal ends of said accessing device, with a distal end of said passage defining an exit port for directing a selected agent, which is passed through the passage, into a central region of the expandable member and any such cavity formed thereby. - View Dependent Claims (25, 26, 27, 28, 29, 30, 31, 32, 33, 37)
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34. A drug-delivery tool for delivering a selected diagnostic or therapeutic agent to a target site within a selected body tissue, comprising:
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(i) an accessing device having proximal and distal ends, with a lumen extending between said ends and terminating at an orifice at said distal end;
(ii) a tissue-penetrating implement movable between a retracted condition, within a distal region of said lumen, and an extended condition, extending out of said orifice;
wherein said implement includes (i) a tip configured to penetrate a selected body tissue when the distal end of the accessing device is placed there against and the implement is moved from its retracted condition to its extended condition, and (ii) a cage member disposed proximal of said tip for following the tip to a target site within such tissue, and adapted to assist in the formation and maintenance of a cavity at the target site by pressing the tissue at the target site away from the longitudinal axis of the implement as it is inserted therein and having sufficient rigidity to resist inwardly directed forces of the tissue tending to collapse the cavity; and
(iii) an agent-delivery passage disposed longitudinally between the proximal and distal ends of said accessing device, with a distal end of said passage defining an exit port facing said cage member for directing a selected agent, which is passed through the passage, into a central region of the cage member and any such cavity formed thereby. - View Dependent Claims (35, 38)
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Specification