The invention provides a device for Encapsulated Cell Therapy. The device includes an implantable capsule containing cells which secrete a biologically active compound for providing a biological function. The capsule has a semi permeable outer membrane for delivery of the compound e.g. at a site in
The invention provides a device for Encapsulated Cell Therapy. The device includes an implantable capsule containing cells which secrete a biologically active compound for providing a biological function. The capsule has a semi permeable outer membrane for delivery of the compound e.g. at a site in the central nervous system or the spinal cord, e.g. in the brain of a patient. The capsule is connected to a tether which e.g. facilitates removal of the capsule from the patient. To facilitate insertion of the capsule into the patient, a stiffener may be attached to the tether to make the tether more rigid. The invention further provides a container for storing a cell therapy device and a method of locating the device in the body of a patient.
대표청구항▼
1. An implantable therapy system for providing a biologically active compound to an individual, said system comprising: a. a cylindrical capsule comprising a proximal end, a distal end, and a biocompatible semi-permeable outer membrane encapsulating isolated cells which are capable of secreting a bi
1. An implantable therapy system for providing a biologically active compound to an individual, said system comprising: a. a cylindrical capsule comprising a proximal end, a distal end, and a biocompatible semi-permeable outer membrane encapsulating isolated cells which are capable of secreting a biologically active compound, the membrane allowing passage of said compound;b. an elongated tether, said tether being made from flexible tubing and comprising a proximal end, a distal end, and a conduit originating at said distal end; andc. an elongated stiffener by which the system can be handled, comprising a first portion and a second portion, wherein: the proximal end of said capsule is joined to the distal end of said elongated tether such that said capsule and elongated tether have co-axial orientation;said tether comprises a segment that is non-overlapping with said capsule, said segment of said tether having a radial size greater than or equal to the radial size of the proximal end of said capsule;said first portion of said stiffener is disposed in, and detachably attached to, said conduit; andsaid second portion of said stiffener extends from the proximal end of said tether and is non-overlapping with said tether. 2. A system according to claim 1, wherein the capsule has a radial size smaller than the radial size of the tether. 3. A system according to claim 1, wherein the stiffener extends coaxially inside the tether. 4. A system according to claim 1, wherein said first portion of said stiffener has a cross-sectional size and shape which matches the cross-sectional size and shape of the conduit of the tether to establish interference fit therein between thereby to detachably attach the stiffener to the tether. 5. A system according to claim 1, wherein said second portion of said stiffener is wider in the cross-sectional direction than said first portion of said stiffener. 6. A system according to claim 1, wherein the stiffener coextends substantially the entire length of the tether including where there is a clearance between the distal end of the stiffener and the capsule. 7. A system according to claim 1, wherein the stiffener is adhesively bonded to the tether. 8. A system according to claim 7, wherein an outer surface of the stiffener comprises a handling means adapted to engage with a separate handle. 9. A system according to claim 1, further comprising a separate handle for attachment to a handling means of the tether or the stiffener. 10. A method of inserting in an individual an implantable therapy system of claim 1, the system being stored in a container with a closure to which the stiffener or the tether is attached, said method comprising the steps of: a. withdrawing the system from the container by removing a closure of the container,b. attaching a separate handle to the tether or to the stiffener,c. inserting a tip of the system into a cannula by holding a gripping element and the separate handle,d. removing the gripping element and further inserting the system into the cannula,e. positioning the tip of the system at a tip of the cannula,f. inserting the cannula and the system simultaneously into a surgically exposed insertion site of the individual,g. withdrawing the cannula while maintaining the location of the system by use of the separate handle, andh. detaching and withdrawing the stiffener from the tether. 11. A system according to claim 1, further comprising a gripping element detachably attached to the tether and/or to the stiffener. 12. A system according to claim 11, wherein the gripping element forms a passage with a cross sectional shape and size, the gripping element being changeable between a relaxed state wherein an inner surface of the passage contacts an outer surface of the tether and/or the stiffener to attach the gripping element to the therapy system and a strained state wherein the passage is deflected to release the therapy system from the gripping element. 13. A system according to claim 12, wherein the gripping element is made from a resilient material. 14. A system according to claim 12, wherein the passage forms the shape of a semicircular incision between a first and a second arm segment. 15. A system according to claim 12, contained in a container which prevents contamination of the capsule and wherein the gripping element is dimensioned relative to the container to prevent contact between the system and inner walls of the container. 16. A system according to claim 12, wherein the gripping element may be shifted between the relaxed and the strained state by application of a releasing pressure to an outer surface of the gripping element. 17. A system according to claim 16, wherein the gripping element further comprises a third and a fourth arm segment extending from the passage in different directions to facilitate application of the releasing pressure. 18. A system according to claim 1, contained in a container which prevents contamination of the capsule. 19. A system according to claim 18, further comprising a gripping element and wherein the gripping element is dimensioned relative to the container to prevent contact between the system and inner walls of the container. 20. A system according to claim 18, wherein the container forms an opening being closed by a closure, wherein the therapy system is attached to the closure, preferably via the stiffener. 21. A system according to claim 20, wherein the closure (32) comprises a seal (34) comprising a fixation member (35) made of a resilient material and provided with an opening dimensioned to fit closely around a portion of at least one of the stiffener and the tether. 22. A system according to claim 20, wherein at least one of the tether and the stiffener extend(s) through the closure and forms an exposed portion located outside the container. 23. A system according to claim 22, wherein the exposed portion of the at least one of the tether and the stiffener extending through the closure and forming the exposed portion comprises a handling means adapted to engage with a separate handle.
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