Devices and methods for adjusting the insertion depth of a needle for medicament delivery
Inventors
Andino, Rafael V. • HANCOCK, Shelley Eckert
Assignees
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Publication Number
US-10973681-B2
Publication Date
2021-04-13
Expiration Date
Abstract
An apparatus includes a housing, an adjustment member, and a microneedle. The housing can be coupled to a medicament container, and includes a hub surface that can contact a target surface. The adjustment member is within the housing and separates an inner volume of the housing into a first chamber and a second chamber. The first chamber is fluidically coupled with the medicament container. The adjustment member, which is coupled to the microneedle, can transition between a first configuration and a second configuration. A proximal end portion of the microneedle is fluidically coupled to the first chamber such that a substance can be conveyed from the medicament container through the microneedle. A distal tip of the microneedle extends from the hub surface by a first distance when the adjustment member is in the first configuration, and by a second distance when the adjustment member is in the second configuration.
Core Innovation
A method is provided in which a distal tip of a puncture member is inserted into a first region of a target tissue using a medical injector that includes a medicament container, a hub, an adjustment member, and the puncture member fixedly coupled to and extending distally from the adjustment member. The distal tip extends from a distal end surface of the hub by a first distance before and during the inserting. The adjustment member is disposed within an inner volume of the hub so that the inner volume is separated into a first chamber and a second chamber fluidically isolated from the first chamber by the adjustment member.
The adjustment member transitions within the inner volume between a first configuration and a second configuration. When the distal tip is within the first region of the target tissue, a substance is conveyed from the medicament container into the first chamber to produce a pressure within the first chamber, and the pressure causes the adjustment member to transition to the second configuration. This causes the distal tip of the puncture member to move within the first region such that the distal tip extends from the distal end surface by a second distance greater than the first distance and into a second region of the target tissue.
The pressure is insufficient to produce a flow of the substance from the first chamber through the puncture member when the distal tip is within the first region of the target tissue. The pressure is sufficient to produce flow of the substance from the first chamber through the puncture member when the distal tip is within the second region of the target tissue. In additional embodiments, the first region and the second region are defined in ocular anatomy, and the first region and second region may be characterized by density differences to support the pressure/flow behavior.
Claims Coverage
Two independent claims are identified, each covering an injection method that uses a fluidically isolated hub chamber and an adjustment member that transitions under pressure or force so the puncture tip moves from a first region to a second region while flow is prevented in the first region and allowed in the second region. Across the independent claims, inventive features center on separation of an inner volume into a fluidically isolated first chamber and second chamber, pressure- or force-driven transition of the adjustment member to change effective puncture depth, and region-dependent flow through the puncture member based on pressure sufficiency or insufficiency.
Region-dependent flow by fluidically isolated hub chambers with adjustment-driven tip extension
Inserting a distal tip of a puncture member into a first region of a target tissue using a medical injector having a medicament container, a hub, and an adjustment member with the puncture member fixedly coupled to and extending distally from the adjustment member; the adjustment member separates an inner volume of the hub into a first chamber and a second chamber fluidically isolated from the first chamber; the first chamber is in fluid communication with the medicament container; transitioning the adjustment member within the inner volume between a first configuration and a second configuration; conveying a substance into the first chamber when the distal tip is within the first region to produce a pressure that causes the adjustment member to transition so the distal tip moves from the first region into a second region with an increased effective extension; the pressure being insufficient to produce flow through the puncture member when the distal tip is within the first region and sufficient to produce flow when the distal tip is within the second region.
Force insufficient to flow in first region and sufficient to flow in second region via adjustment-member transition and distal tip movement
Inserting a distal tip of a puncture member into a first region of a target tissue using a medical injector having a medicament container, a hub, and an adjustment member with the puncture member fixedly coupled to and extending distally from the adjustment member; the distal tip extends from a distal end surface of the hub before and during inserting; the adjustment member separates an inner volume of the hub into a first chamber and a second chamber fluidically isolated from the first chamber; the first chamber is in fluid communication with the medicament container; the adjustment member configured to transition between a first configuration and a second configuration; exerting a force on the medical injector to cause the adjustment member to transition to the second configuration so the distal tip moves distally relative to the distal end surface from the first region to a second region; the force being insufficient to produce flow of a substance from the first chamber through the puncture member when the distal tip is within the first region and sufficient to cause flow when the distal tip is within the second region.
Both independent claims require a hub inner volume separated into a fluidically isolated first chamber and second chamber by an adjustment member, with an adjustment-member transition driven by pressure or force to move the distal tip from a first region to a second region. Each claim further requires region-dependent flow: pressure or force is insufficient to produce flow when the distal tip is in the first region and sufficient to produce flow when the distal tip is in the second region.
Stated Advantages
Enables conveying a substance and producing flow through the puncture member only when the distal tip is within the second region of the target tissue.
Prevents flow of the substance through the puncture member when the distal tip is within the first region of the target tissue.
Documented Applications
Non-surgical posterior eye targeting using an injection method that delivers a substance to ocular regions including the suprachoroidal space.
Delivery of therapeutics including VEGF and VEGF inhibitors, PDGFR inhibitors, and triamcinolone, as well as rapamycin (sirolimus), in posterior eye contexts described in the document.
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