Systems and methods for delivering therapeutic agents to selected sites in a subject
First Claim
1. A system for delivering a therapeutic agent to a selected site in a subject, comprising:
- a rigid guide cannula for penetrating the subject to a site adjacent to the selected site, the guide cannula having an axial bore extending therethrough within which a delivery cannula can be disposed, an open proximal end, an opening at a distal portion thereof, a distal end which is a blunt end, and a wall which is sufficiently rigid such that it is capable of deflecting, at a predetermined deflection angle relative to the midline of the guide cannula, a delivery cannula disposed therein as the delivery cannula is extended through the opening at the distal portion of the guide cannula; and
a delivery cannula disposable within the guide cannula for delivering the therapeutic agent to the selected site in the subject, the delivery cannula having an axial bore extending therethrough, a flexible distal end portion, and an outer diameter which is less than the inner diameter of the guide cannula, wherein the delivery cannula, when extended through the opening at the distal portion of the guide cannula, is adapted to be deflected by a wall of the guide cannula at a predetermined deflection angle relative to the midline of the guide cannula and along a new trajectory imposed by the deflection angle and thereafter maintaining the new trajectory in the subject without being diverted by forces imposed by structures within the subject.
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Accused Products
Abstract
Systems for delivering a therapeutic agent to a selected site in a subject are disclosed. These systems enable precise placement of selected amounts, e.g., very small amounts, of a therapeutic agent to a predetermined site or sites in a three dimensional array in a subject with minimal trauma to the subject. These delivery systems include a guide cannula for penetrating a selected site in a subject to a predetermined depth and a delivery cannula for delivering the therapeutic agent to the subject. The guide cannula has an axial bore extending therethrough with an open proximal end and an opening at a distal portion thereof. The delivery cannula has an axial bore extending therethrough, a flexible distal end portion, and an outer diameter which is less than the inner diameter of the guide cannula. Methods of delivering therapeutic agents to selected sites in a subject using these delivery systems are also described.
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Citations
34 Claims
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1. A system for delivering a therapeutic agent to a selected site in a subject, comprising:
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a rigid guide cannula for penetrating the subject to a site adjacent to the selected site, the guide cannula having an axial bore extending therethrough within which a delivery cannula can be disposed, an open proximal end, an opening at a distal portion thereof, a distal end which is a blunt end, and a wall which is sufficiently rigid such that it is capable of deflecting, at a predetermined deflection angle relative to the midline of the guide cannula, a delivery cannula disposed therein as the delivery cannula is extended through the opening at the distal portion of the guide cannula; and a delivery cannula disposable within the guide cannula for delivering the therapeutic agent to the selected site in the subject, the delivery cannula having an axial bore extending therethrough, a flexible distal end portion, and an outer diameter which is less than the inner diameter of the guide cannula, wherein the delivery cannula, when extended through the opening at the distal portion of the guide cannula, is adapted to be deflected by a wall of the guide cannula at a predetermined deflection angle relative to the midline of the guide cannula and along a new trajectory imposed by the deflection angle and thereafter maintaining the new trajectory in the subject without being diverted by forces imposed by structures within the subject. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 20, 21, 22, 23)
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10. A system for delivering a therapeutic agent to a selected site in a subject, comprising:
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a guide cannula for penetrating the subject to a site adjacent to the selected site, the guide cannula having an axial bore extending therethrough, the guide cannula further having an open proximal end and an opening at a distal portion thereof; and a delivery cannula disposable within the guide cannula for delivering the therapeutic agent to the subject, the delivery cannula tapering from a proximal end to a distal end to form a tube having a diameter at its distal end which is at least five fold smaller than the diameter at its proximal end, the delivery cannula further having an axial bore extending therethrough, a flexible distal end portion, and an outer diameter which is less than the bore diameter of the guide cannula. - View Dependent Claims (11, 12, 13, 14, 15, 24, 25, 26)
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16. A method for delivering a therapeutic agent to a selected site in a subject, comprising:
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(a) inserting a rigid guide cannula adjacent to a selected site in the subject, the guide cannula having an axial bore extending therethrough within which a delivery cannula can be disposed, an open proximal end, an opening at a distal portion thereof, a distal end which is a blunt end, and a wall which is sufficiently rigid such that it is capable of deflecting, at a predetermined deflection angle relative to the midline of the guide cannula, a delivery cannula disposed therein as the delivery cannula is extended through the opening at the distal portion of the guide cannula; (b) inserting a delivery cannula into the guide cannula proximal to the opening at the distal portion, the delivery cannula releasably holding the therapeutic agent and having a flexible distal end portion and an outer diameter which is less than the bore diameter of the guide cannula, wherein the delivery cannula, when extended through the opening at the distal portion of the guide cannula, is adapted to be deflected by a wall of the guide cannula at a predetermined deflection angle relative to the midline of the guide cannula and along a new trajectory imposed by the deflection angle and thereafter maintaining the new trajectory in the subject without being diverted by forces imposed by structures within the subject; (c) extending the delivery cannula through the opening at the distal portion of the guide cannula along a first extension path to the selected site in the subject; and (d) releasing the therapeutic agent from the delivery cannula at the selected site in the subject to form an injection site. - View Dependent Claims (17, 18, 19, 30)
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27. A system for delivering a therapeutic agent to a selected site in a subject, comprising:
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a rigid guide cannula for penetrating the subject to a site adjacent to the selected site, the guide cannula having an axial bore extending therethrough within which a delivery cannula can be disposed, an open proximal end, an opening at a distal portion thereof, a distal end which is a blunt end, and a wall which is sufficiently rigid such that it is capable of imposing a predetermined trajectory on a delivery cannula disposed therein as the delivery cannula is extended through the opening at the distal portion of the guide cannula; and a delivery cannula disposable within the guide cannula for delivering the therapeutic agent to the selected site in the subject, the delivery cannula having an axial bore extending therethrough, a flexible distal end portion, and an outer diameter which is less than the bore diameter of the guide cannula, wherein the delivery cannula, when extended through the opening at the distal portion of the guide cannula at a predetermined trajectory imposed by the guide cannula, is capable of maintaining the trajectory within the selected site in the subject without being diverted by forces imposed by structures within the subject.
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28. A system for delivering a therapeutic agent to a selected site in a subject, comprising:
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a rigid guide cannula for penetrating the subject to a site adjacent to the selected site, the guide cannula having an axial bore extending therethrough, an open proximal end, an opening at a distal portion thereof, and a distal end which is a blunt end; and a delivery cannula disposable within the guide cannula for delivering the therapeutic agent to the subject, the delivery cannula having an axial bore extending therethrough, a flexible distal end portion, and an outer diameter at its distal most end which ranges from 1 micron to 700 microns. - View Dependent Claims (29)
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31. A method for delivering a therapeutic agent to a selected site in a subject, comprising:
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(a) inserting a rigid guide cannula adjacent to a selected site in the subject, the guide cannula having an axial bore extending therethrough within which a delivery cannula can be disposed, an open proximal end, an opening at a distal portion thereof, a distal end which is a blunt end, and a wall which is sufficiently rigid such that it is capable of imposing a predetermined trajectory on a delivery cannula disposed therein as the delivery cannula is extended through the opening at the distal portion of the guide cannula; (b) inserting a delivery cannula into the guide cannula proximal to the opening at the distal portion, the delivery cannula releasably holding the therapeutic agent and having a flexible distal end portion and an outer diameter which is less than the bore diameter of the guide cannula, wherein the delivery cannula, when extended through the opening at the distal portion of the guide cannula at a predetermined trajectory imposed by the guide cannula, is capable of maintaining the trajectory within the selected site in the subject without being diverted by forces imposed by structures within the subject; (c) extending the delivery cannula through the opening at the distal portion of the guide cannula along a first extension path to the selected site in the subject; and (d) releasing the therapeutic agent from the delivery cannula at the selected site in the subject to form an injection site.
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32. A method for delivering a therapeutic agent to a selected site in a subject, comprising:
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(a) inserting a rigid guide cannula adjacent to a selected site in the subject, the guide cannula having an axial bore extending therethrough within which a delivery cannula can be disposed, an open proximal end, an opening at a distal portion thereof, a distal end which is a blunt end, and a wall which is sufficiently rigid such that it is capable of deflecting, at a predetermined deflection angle relative to the midline of the guide cannula, a delivery cannula disposed therein as the delivery cannula is extended through the opening at the distal portion of the guide cannula;
the guide cannula further having disposed within its bore a delivery cannula releasably holding the therapeutic agent and having a flexible distal end portion and an outer diameter which is less than the bore diameter of the guide cannula, wherein the delivery cannula, when extended through the opening at the distal portion of the guide cannula, is adapted to be deflected by a wall of the guide cannula at a predetermined deflection angle relative to the midline of the guide cannula and along a new trajectory imposed by the deflection angle and thereafter maintaining the new trajectory in the subject without being diverted by forces imposed by structures within the subject;(b) extending the delivery cannula through the opening at the distal portion of the guide cannula along a first extension path to the selected site in the subject; and (c) releasing the therapeutic agent from the delivery cannula at the selected site in the subject to form an injection site.
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33. A method for delivering a therapeutic agent to a selected site in a subject, comprising:
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(a) inserting a rigid guide cannula adjacent to a selected site in the subject, the guide cannula having an axial bore extending therethrough within which a delivery cannula can be disposed, an open proximal end, an opening at a distal portion thereof, a distal end which is a blunt end, and a wall which is sufficiently rigid such that it is capable of imposing a predetermined trajectory on a delivery cannula disposed therein as the delivery cannula is extended through the opening at the distal portion of the guide cannula;
the guide cannula further having disposed within its bore a delivery cannula releasably holding the therapeutic agent and having a flexible distal end portion and an outer diameter which is less than the bore diameter of the guide cannula, wherein the delivery cannula, when extended through the opening at the distal portion of the guide cannula at a predetermined trajectory imposed by the guide cannula, is capable of maintaining the trajectory within the selected site in the subject without being diverted by forces imposed by structures within the subject;(b) extending the delivery cannula through the opening at the distal portion of the guide cannula along a first extension path to the selected site in the subject; and (c) releasing the therapeutic agent from the delivery cannula at the selected site in the subject to form an injection site.
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34. A system for delivering a therapeutic agent to a selected central nervous system site in a subject, comprising:
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a therapeutic agent comprising cells; a guide cannula for penetrating the subject to a site adjacent to the selected site, the guide cannula having an axial bore extending therethrough within which a delivery cannula can be disposed, an open proximal end, an opening at a distal portion thereof, and a wall which is sufficiently rigid such that it is capable of deflecting, at a predetermined deflection angle relative to the midline of the guide cannula, a delivery cannula disposed therein as the delivery cannula is extended through the opening at the distal portion of the guide cannula; and a delivery cannula disposable within the guide cannula for delivering the therapeutic agent to the selected site in the subject, the delivery cannula having an axial bore extending therethrough, a flexible distal end portion, and an outer diameter which is less than the bore diameter of the guide cannula, wherein the delivery cannula, when extended through the opening at the distal portion of the guide cannula, is adapted to be deflected by a wall of the guide cannula at a predetermined deflection angle relative to the midline of the guide cannula and along a new trajectory imposed by the deflection angle and thereafter maintaining the new trajectory in the subject without being diverted by forces imposed by structures within the subject.
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Specification