Implantable therapy systems and methods
First Claim
1. A system for delivering a biologically active factor to a selected treatment site in a subject, comprising:
- i) a single cannula adapted for penetration through tissue into a selected position in proximity with the treatment site, having a bore with a substantially smooth interior surface running axially therethrough through which a vehicle may slidably move, an open, proximal end into which the vehicle may be slidably inserted and a distal end having an opening through which the vehicle may slidably move wherein the external diameter and bore diameter are tapered toward the distal tip;
ii) an obturator disposable within the cannula to prevent tissue material from entering the distal end of the cannula when it is inserted into tissue;
iii) a vehicle which encapsulates the biologically active factor, the vehicle having an outer surface which comprises a biocompatible semipermeable outer membrane through which the biologically active factor may be released into the selected treatment site, and a shape which enables slidable insertion into the proximal end of the cannula, slidable movement along the bore of the cannula, slidable passage through the distal end of the cannula by removal of the cannula from the proximity of the treatment site; and
iv) a pusher disposable within the cannula to engage the outer surface of the vehicle, to slidably move the vehicle through the bore, and to hold the vehicle in place at the selected treatment site when the cannula is removed from the proximity of the treatment site, the pusher being removable after the vehicle is positioned at the treatment site.
1 Assignment
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Accused Products
Abstract
Implantable therapy systems are disclosed for the local and controlled delivery of a biologically active factor to the brain, spinal cord and other target regions of a subject suffering from a debilitating condition. The method of the invention involves surgically exposing an insertion site, generally located above a predetermined treatment site (12), in a patient. A cannula (20), having an obturator (30) or dilator (104) positioned therein, is inserted at the insertion site, defining a pathway to the treatment site. In some instances, the cannula can be inserted along the path of a guidewire (102) previously positioned at the treatment site. The cannula (20) is preferably a low friction polymeric material such as polytetrafluoroethylene. The cannula (20) generally has an open proximal end for receiving the obturator (30) or dilator (104), and an open distal end, preferably a tapered end, for delivery of neurologically active factors to the treatment site (12). The obturator (30) is then removed from the cannula (20), and a biocompatible tethered vehicle (40) containing a biologically active material is inserted into the cannula along the passageway. A pusher can be inserted within the cannula, behind the vehicle (40), to position the proximal end of the vehicle at the distal end of the cannula (20b). Once the vehicle (40) is positioned near the distal end of the cannula (20), the cannula is removed from the passageway, followed by the pusher, leaving the vehicle (40) positioned at the treatment site (12).
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Citations
20 Claims
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1. A system for delivering a biologically active factor to a selected treatment site in a subject, comprising:
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i) a single cannula adapted for penetration through tissue into a selected position in proximity with the treatment site, having a bore with a substantially smooth interior surface running axially therethrough through which a vehicle may slidably move, an open, proximal end into which the vehicle may be slidably inserted and a distal end having an opening through which the vehicle may slidably move wherein the external diameter and bore diameter are tapered toward the distal tip; ii) an obturator disposable within the cannula to prevent tissue material from entering the distal end of the cannula when it is inserted into tissue; iii) a vehicle which encapsulates the biologically active factor, the vehicle having an outer surface which comprises a biocompatible semipermeable outer membrane through which the biologically active factor may be released into the selected treatment site, and a shape which enables slidable insertion into the proximal end of the cannula, slidable movement along the bore of the cannula, slidable passage through the distal end of the cannula by removal of the cannula from the proximity of the treatment site; and iv) a pusher disposable within the cannula to engage the outer surface of the vehicle, to slidably move the vehicle through the bore, and to hold the vehicle in place at the selected treatment site when the cannula is removed from the proximity of the treatment site, the pusher being removable after the vehicle is positioned at the treatment site. - View Dependent Claims (2, 3, 4, 5, 6, 7, 8, 9, 10, 11, 12, 13, 14, 15, 16)
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17. A method for delivering a biologically active factor to a selected treatment site in a subject, comprising:
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i) surgically opening an insertion site located near the selected treatment site; ii) inserting a single cannula adapted for penetration through tissue and an obturator disposed therein into the insertion site and placing the distal end of the cannula at a selected position in proximity with the treatment site, the cannula having a bore with a substantially smooth surface running axially therethrough through which a vehicle may slidably move, an open, proximal end into which the vehicle may be slidably inserted and a distal end having an opening through which the vehicle may slidably move wherein the external diameter an bore diameter are tapered toward the distal tip; iii) removing the obturator from the cannula; iv) introducing within the bore of the cannula a vehicle which encapsulates the biologically active factor, the vehicle having an outer surface which comprises a biocompatible semipermeable outer membrane through which the biologically active factor may be released into the selected treatment site, and a shape which enables slidable insertion into the proximal end of the cannula, slidable movement along the bore of the cannula, slidable passage through the distal end of the cannula by removal of the cannula from the proximity of the treatment site; v) delivering the vehicle to the distal end of the cannula with a pusher disposable within the cannula to engage the outer surface of the vehicle, to slidably move the vehicle through the bore, and to hold the vehicle in place at the selected treatment site when the cannula is removed from the proximity of the treatment site; vi) removing the cannula from the tissue, while leaving the vehicle inserted at the treatment site; and vii) removing the pusher from the tissue. - View Dependent Claims (18, 19, 20)
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Specification