Patent Application
20230101775
Provided herein is a package for retaining and dispensing a delivery shaft assembly for delivery of an implant for implantation in a subject.
Implants are often used to treat conditions where medicinal treatment has become ineffective or is not available. Techniques for placement of an implant typically rely on an inserter tool that temporarily holds the implants and provides an elongated reach for placement at the implantation site and a mechanism for ejection from the inserter. Implants can be very small, for instance, implants for the treatment of glaucoma typically have a length of 5 mm and a width of 1 mm. An example of an implant and inserter too for treatment of glaucoma is disclosed, for instance, in WO 2017/108498.
A problem in the art is how to store the implant prior to use so that it is in an optimum condition. A small implant can be difficult to load into an inserter just prior to use. Some implants need to be maintained under liquid storage without damage or without being exposed to air pockets.
Described herein is a package (100) for holding and dispensing a delivery shaft assembly (200) for delivery of an implant (230), wherein
The delivery shaft retaining mechanism (310) may comprise a 1st body (312) and 2nd body (314) configured to co-operate to clamp at least a part of the delivery shaft (220).
The 1st body (312) may be disposed in fixed relation to the force-receiving body (308), and the 2nd body (314) is configured to at least partly move upon actuation of the delivery shaft retaining mechanism (310) away from the 1st body (312) thereby releasing the retained delivery shaft (220).
The delivery shaft retaining mechanism (310) may further comprise an actuating pin (316) and a movement guide (318) wherein an application of force by the inserter tool during coupling advances the pin (316) and movement guide (318) from a retain position to a release position, wherein the movement guide (318), slidably coupled to the 2nd body (314), effects movement of the 2nd body (314) from a retain position to a release position.
The movement guide (318) may comprise at least 1 guiding slot (320) having at least a partly cammed path, the 2nd body (314) may comprise at least one protrusion (322) engaged in the guiding slot (320), movement of the movement guide (318) from the retain to release position may effect sliding of the guiding slot (320) and movement of the at least one protrusion (322) along the cammed path thereby separating at least a part of the 2nd body (314) from the 1st body (312).
The 1st body (312) and the 2nd body (314) may be connected by a hinge, preferably by a living hinge. The vial holding space (410) may be configured for retention of a liquid. The vial (400) may have an opening (412), closable by a cap or removable seal.
The 1st body (312) may be provided with a keeper (324), configured to limit movement of the implant (230) in the delivery shaft (220) lumen (222) in the distal end (40) direction.
The keeper may comprise a projection configured to at least partly engage with the delivery shaft (220) lumen (222).
The 1st body (312) and 2nd body (314) co-operate to clamp at least a part of the delivery shaft in a clamping region such that the delivery shaft lumen (222) in the clamping region (312a, 314a) is at least partly narrowed, thereby limiting movement of the implant (230) in a proximal (20) direction.
The insert (300) may further comprise one or more fluid displacement bodies (340) configured to displace (aqueous) solution from vial holding space (410) during coupling of the insert (300) into the vial holding space (410).
The insert (300) may further comprises an overflow outlet (342) configured for passage of the displaced solution from the vial. The package (100) may further comprise the delivery shaft assembly (200) as defined herein.
Before the present system and method of the invention are described, it is to be understood that this invention is not limited to particular systems and methods or combinations described, since such systems and methods and combinations may, of course, vary. It is also to be understood that the terminology used herein is not intended to be limiting, since the scope of the present invention will be limited only by the appended claims.
As used herein, the singular forms “a”, “an”, and “the” include both singular and plural referents unless the context clearly dictates otherwise.
The terms “comprising”, “comprises” and “comprised of” as used herein are synonymous with “including”, “includes” or “containing”, “contains”, and are inclusive or open-ended and do not exclude additional, non-recited members, elements or method steps. It will be appreciated that the terms “comprising”, “comprises” and “comprised of” as used herein comprise the terms “consisting of”, “consists” and “consists of”.
The recitation of numerical ranges by endpoints includes all numbers and fractions subsumed within the respective ranges, as well as the recited endpoints.
The term “about” or “approximately” as used herein when referring to a measurable value such as a parameter, an amount, a temporal duration, and the like, is meant to encompass variations of +/−10% or less, preferably +/−5% or less, more preferably +/−1% or less, and still more preferably +/−0.1% or less of and from the specified value, insofar such variations are appropriate to perform in the disclosed invention. It is to be understood that the value to which the modifier “about” or “approximately” refers is itself also specifically, and preferably, disclosed.
Whereas the terms “one or more” or “at least one”, such as one or more or at least one member(s) of a group of members, is clear per se, by means of further exemplification, the term encompasses inter alia a reference to any one of said members, or to any two or more of said members, such as, e.g., any ≥3, ≥4, ≥5, ≥6 or ≥7 etc. of said members, and up to all said members.
All references cited in the present specification are hereby incorporated by reference in their entirety. In particular, the teachings of all references herein specifically referred to are incorporated by reference.
Unless otherwise defined, all terms used in disclosing the invention, including technical and scientific terms, have the meaning as commonly understood by one of ordinary skill in the art to which this invention belongs. By means of further guidance, term definitions are included to better appreciate the teaching of the present invention.
In the following passages, different aspects of the invention are defined in more detail. Each aspect so defined may be combined with any other aspect or aspects unless clearly indicated to the contrary. In particular, any feature indicated as being preferred or advantageous may be combined with any other feature or features indicated as being preferred or advantageous.
Reference throughout this specification to “one embodiment” or “an embodiment” means that a particular feature, structure or characteristic described in connection with the embodiment is included in at least one embodiment of the present invention. Thus, appearances of the phrases “in one embodiment” or “in an embodiment” in various places throughout this specification are not necessarily all referring to the same embodiment, but may. Furthermore, the particular features, structures or characteristics may be combined in any suitable manner, as would be apparent to a person skilled in the art from this disclosure, in one or more embodiments. Furthermore, while some embodiments described herein include some but not other features included in other embodiments, combinations of features of different embodiments are meant to be within the scope of the invention, and form different embodiments, as would be understood by those in the art. For example, in the appended claims, any of the claimed embodiments can be used in any combination.
In the present description of the invention, reference is made to the accompanying drawings that form a part hereof, and in which are shown by way of illustration only of specific embodiments in which the invention may be practiced. Parenthesized or emboldened reference numerals affixed to respective elements merely exemplify the elements by way of example, with which it is not intended to limit the respective elements. It is to be understood that other embodiments may be utilised and structural or logical changes may be made without departing from the scope of the present invention. The following detailed description, therefore, is not to be taken in a limiting sense, and the scope of the present invention is defined by the appended claims.
The terms “distal” or “distal to” and “proximal” or “proximal to” are used throughout the specification, and are terms generally understood in the field to mean towards (proximal) or away (distal) from the user's (practitioners) side of an apparatus. Thus, “proximal” or “proximal to” means towards the user's side and, therefore, away from the subject's (patient's) side. Conversely, “distal” or “distal to” means towards the subject's side and, therefore, away from the users side. The term “subject” refers to the human or animal receiving the implant. The term “user” refers to the person performing the implantation (e.g. surgeon, specialist, practitioner).
Provided herein is a package (100) for holding and dispensing a delivery shaft assembly (200) for delivery of an implant (230) as exemplified for instance in
Advantageously, the package (100) stabilises the position of the delivery shaft assembly (200) within the vial (400) during transport and storage, preventing unintentional loss of implant from the delivery shaft by transport and handling agitation. By linking a release or retain state of shaft retaining mechanism (310) to an application of force by the inserter tool (500), the delivery shaft assembly (200) is retained in the vial holding space (410) and liquid up until the moment of use, and is released from the insert (300) at the same time as inserter tool couples to it. The package (100) may or may not include the delivery shaft assembly (200). The package (100) may or may not include the inserter tool (500).
The delivery shaft assembly (200) comprises an adapter (210) and a delivery shaft (220). The delivery shaft (220) is provided with a lumen (222) holding the implant (230), and an adapter (210) configured for coupling to the inserter tool (500). The implant (230) is disposed at or towards a distal end (40) of the delivery shaft (220). The adapter (210) is disposed at a proximal end (20) of the delivery shaft (220). The adapter (210) has a body provided with a receiving space (212) fora part of the inserter tool (500) and an aperture (214) connecting the receiving space (212) to a lumen (222) of delivery shaft (220). The lumen (222) is configured for the passage of a discharge shaft (510) of the inserter tool (500) therethrough. The implant (230) may be ejected from the delivery shaft (220) by actuation of the inserter tool (500), thereby delivering the implant (230) to the target. An exemplary delivery shaft assembly (200) is disclosed in WO 2017/108498, which is incorporated herein by reference.
The inserter tool (500) is provided with a discharge shaft (510) configured to be received by the delivery shaft assembly lumen (220). The discharge shaft (510) may be configured abut the implant (230). Movement of the delivery shaft (220) and/or of the discharge shaft (510) causes release of the implant (230) from the lumen (222)
Advancement of the discharge shaft (510) in a distal (40) direction may apply force to the implant (230), causing it to be ejected from the shaft assembly lumen (220). Alternatively or additionally, withdrawal of the delivery shaft (220) relative to a fixed discharge shaft (510) causes the implant (230) to be ejected from the shaft assembly lumen (220).
The inserter tool (500) is provided with an adapter coupling (520) configured to couple with the adapter (210). The coupling between the adapter coupling (520) and adapter (210) may be releasable or non-releasable. A non-releasable coupling may be achieved, for instance, by providing a compliant member on one of the adapter coupling (520) or adapter (210) and a reciprocating stop member on the other, wherein the compliant member slides across the stop member in one direction during couple the parts (520, 210) and the compliant member engages with the stop member in the other sliding direction to prevent release of the parts (520, 210). The mechanism is similar to the one-directional movement of a ratchet mechanism.
Where the implant is ejected by withdrawal of the delivery shaft (220) relative to the fixed discharge shaft (510), the adapter coupling (520) may be slidable relative to the fixed discharge shaft (510). The slidable adapter coupling (520) has a primed and deployed position. In the primed position, the slidable adapter coupling (520) places the adapter (210) and delivery shaft lumen (222) in a distal-most position. The fixed discharge shaft (510) may abut the implant (230) and the delivery shaft lumen (222) may cover the implant (230). In the deployed position, the slidable adapter coupling (520) places the adapter (210) and delivery shaft lumen (222) in a proximal-most position. The discharge shaft (510) abuts the implant (230) and the delivery shaft lumen (222) is withdrawn in a proximal (20) direction and the implant (230) is released. Where the implant is ejected by advancement of the discharge shaft (510), the discharge shaft (510) slidable relative to a fixed adapter coupling (520) applied an ejection force in a distal direction upon the implant (230) causing it to be ejected from the lumen (222).
An example of a part of an inserter tool (500) is provided in
An exemplary inserter tool (500) is disclosed in WO 2017/108498, which is incorporated herein by reference.
The shaft retaining mechanism (310) may have a retain state (in which the delivery shaft (222) and hence delivery shaft assembly (200) are held fast by the shaft retaining mechanism (310)) and a release state (in which the delivery shaft (222) and hence delivery shaft assembly (200) are free of the insert (300)). Movement from the retain state to the release state is actuated by force of the inserter tool (500) during coupling to the adapter (210). An exemplary shaft retaining mechanism (310) is shown in
The shaft retaining mechanism (310) may comprise a 1st body (312) and 2nd body (314) configured to co-operate (in the retain state) to clamp at least a part of the delivery shaft (222). The delivery shaft (220) may be clamped in fixed relation to the force receiving body.
The 1st body (312) and 2nd body (314) may co-operate in the retain state to clamp at least a part of the delivery shaft in a clamping region (312a, 314a) such that the delivery shaft lumen (222) in the clamping region is at least partly narrowed, thereby limiting movement of the implant (230) in a proximal (20) direction. An exemplary clamping region (312a, 314a) narrowing the delivery shaft lumen (222) is shown in
The 1st body (312) may be disposed in fixed (non-moveable) relation to the force-receiving body (308). The 2nd body (314) may be configured to at least partly move upon actuation of the shaft retaining mechanism (310) away from the 1st body (312) thereby releasing the retained delivery shaft (220).
The 1st body (312) and 2nd body (314) may be longitudinal. The 1st body (312) and 2nd body (314) may be longitudinal in a proximal-distal direction. The 1st body (312) and the 2nd body (314) may be connected by a hinge (e.g. living hinge).
The shaft retaining mechanism (310) may further comprising an actuating pin (316) and a movement guide (318). The actuating pin (316) may be attached in fixed relation to the movement guide (318). An application of force by the inserter tool (500) during coupling advances the pin (316) and movement guide (318) from a retain position to a release position. The movement guide (318), slidably coupled to the 2nd body (314), effects movement of the 2nd body (314) from a retain position to a release position.
The movement guide (318) comprises at least 1, or 2 or more (preferably 2) guiding slots (320) having at least a partly cammed path. The cammed path is a linear cam that translates a linear movement in a 1st direction (e.g. proximal-distal) to a linear movement in a 2nd direction (e.g. perpendicular to the 1st direction).
The 2nd body (314) may comprise a protrusion (322) engaged in a guiding slot (320). There may be one protrusion (322) per guiding slot (320). The protrusion (322) may be fixed relation to the 2nd body. The protrusion (322) may be a follower for the cammed path.
Movement of the movement guide (318) from the retain to release position effects sliding (in a 1st direction) of the guiding slot (320) and movement (in a 2nd direction) of the protrusion (322) along the cammed path thereby separating at least a part of the 2nd body (314) from the 1st body (312).
The 1st body (312) or second body (314), preferably the 1st body (312) may be provided with a keeper (324). The keeper may be disposed in fixed (non-moveable) relation to the 1st body (312) or 2nd body (314) respectively. The keeper (324) is configured to co-operate with a distal tip of the delivery shaft (220) to limit movement of the implant (230) in the distal end (40) direction. The keeper (324) may comprises a projection (e.g. conical) configured to at least partly engage with the delivery shaft (220) lumen (222). The keeper (324) may be a solid body extending laterally (perpendicular to a proximal-distal direction).
The insert (300) may further comprise one or more liquid displacement bodies (340). A fluid displacement body (340) is configured to displace liquid from vial holding space (410) during placement of the insert (300) during assembly of the package (100). This allows the vial holding space (410) to be filled with a minimum of air bubbles. A liquid displacement body (340) may have a ring-like appearance. The insert (300) may further comprise an overflow outlet (342) configured for passage of the displaced liquid from the vial. The overflow outlet (342) may extend in a proximal direction as a channel into the one or more liquid displacement bodies (340).
The vial (400) may be formed from a vial body (402) that defines the vial holding space (410). The vial holding space (410) is configured for retention of a liquid e.g. aqueous solution, organic solvent. The vial (400) has an opening (412) at the proximal end (20) configured to receive a distal part of the inserter tool (500). The opening (412) may be closed by a cap or removable seal. The vial (400) may be disposed with one or more support members (420) configured to support the insert (300). The support member (420) is configured limit movement of the insert (300) in a distal (40) direction. In particular, when force is applied by the inserter tool (500) to the force receiving surface (308), the support member (420) prevents movement of and damage to the insert (300). The support member (420) may be provided as a ridge on the vial body (402) that engages with the force receiving body (308). An exemplary vial is shown in detail in
The implant (230) may be any placeable in a subject (animal, human) using an inserter tool. In particular, the implant (230) may be an implant for treatment of glaucoma. In particular, the implant (230) may be an intraocular shunt. The implant (230) may be for implantation between the sclera and the choroid, i.e. in the suprachoroidal space. The implant (230) be an implant as described in WO 2017/108498. In particular, the implant may be as described on page 13, lines 1to page 14, line 5, and/or on page 21, line 25 to page 22 line 21 of WO 2017/108498 which is incorporated herein by reference.
The inserter tool (500) may be an implantation device as described in WO 2017/108498. The delivery shaft assembly (200) may comprise a one-touch fitting connection element or adaptor (210) as described in WO 2017/108498. For example, WO 2017/108498 describes an implantation device (500) and delivery shaft assembly (200) on pages 26 to page 33 which is incorporated herein by reference.
| Number | Date | Country | Kind |
|---|---|---|---|
| 20159797.8 | Feb 2020 | EP | regional |
This application is a national phase entry under 35 U.S.C. § 371 of International Patent Application PCT/EP2021/054858, filed Feb. 26, 2021, designating the United States of America and published in English as International Patent Publication WO 2021/170812 on Sep. 2, 2021, which claims the benefit under Article 8 of the Patent Cooperation Treaty to European Patent Application Serial No. 20159797.8, filed Feb. 27, 2020, the entireties of each of which are hereby incorporated by reference.
| Filing Document | Filing Date | Country | Kind |
|---|---|---|---|
| PCT/EP2021/054858 | 2/26/2021 | WO |
