Device for delivery of multi-component sealants - Patents.com

Abstract

A medical sealant applicator device for delivery of a multi-component sealant, comprising a first body having a base, a first syringe plunger, a second syringe plunger, and a longitudinal channel interposed laterally between the first and second syringe plungers. Each of the first and second syringe plungers is oriented to extend in a first direction from the base. The first syringe plunger has a first free end having a first proximal plunger piston. The second syringe plunger has a second free end having a second proximal plunger piston. A second body of the medical sealant application device has a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber interposed laterally between the first and second syringe chambers. The longitudinal fluid chamber has a proximal end and a distal end.

Description

[Technical field]

[0001]

[0001] The present disclosure relates generally to delivery of sealants for medical procedures, and more particularly to devices, systems, and methods for delivering multi-component sealants in medical procedures. Summary of the Invention [Problem to be solved by the invention]

[0002]

[0002] During a lung biopsy procedure, a potential concern for medical professionals is preventing or reducing the likelihood of air and / or fluid entering the pleural cavity in the lung. Such a condition is known as a pneumothorax and can develop as a result of a puncture hole created during or after a lung biopsy procedure. Pneumothorax is a common event and results in prolonged hospital stays. In addition, subjects may require a chest tube in response to a pneumothorax. A variety of complications resulting from a pneumothorax can make it difficult for medical professionals to seal the puncture hole after the procedure.

[0003]

[0003] Devices and methods have been used to attempt to seal the puncture hole, but these devices and methods are limited because medical personnel may only be able to use a single component sealant and / or may not have the ability to adjust the rate of sealant delivery. [Means for solving the problem]

[0004] According to an embodiment of the present disclosure, a medical sealant applicator device for delivery of a multi-component sealant is provided, the medical sealant applicator device including a first body having a base, a first syringe plunger, a second syringe plunger, and a longitudinal channel interposed laterally between the first and second syringe plungers. Each of the first and second syringe plungers is oriented to extend in a first direction from the base. The first syringe plunger has a first free end having a first proximal plunger piston. The second syringe plunger has a second free end having a second proximal plunger piston. A second body of the medical sealant application device has a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber interposed laterally between the first and second syringe chambers. The longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is fluidly connected to each of the first and second syringe chambers. The distal end of the longitudinal fluid chamber has a distal needle connector port. The first syringe chamber of the second body has a first distal opening for slidably receiving a first proximal plunger piston of a first syringe plunger of the first body. The second syringe chamber of the second body has a second distal opening for slidably receiving a second proximal plunger piston of a second syringe plunger of the first body, and the distal needle connector port of the longitudinal fluid chamber of the second body is capable of translation within the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body.

[0005]

[0005] In another embodiment, a medical sealant applicator device for delivery of a multi-component sealant is provided, the medical sealant applicator device including a first body, a second body, and a guide assembly. The first body has a base, a first syringe plunger, a second syringe plunger, and a longitudinal channel interposed laterally between the first and second syringe plungers. Each of the first and second syringe plungers is oriented to extend in a first direction from the base. The first syringe plunger has a first free end having a first proximal plunger piston. The second syringe plunger has a second free end having a second proximal plunger piston. The second body has a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber interposed laterally between the first and second syringe chambers. The longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is fluidly connected to each of the first and second syringe chambers. The distal end of the longitudinal fluid chamber has a distal needle connector port. The first syringe chamber of the second body has a first distal opening for slidably receiving a first proximal plunger piston of a first syringe plunger of the first body. The second syringe chamber of the second body has a second distal opening for slidably receiving a second proximal plunger piston of a second syringe plunger of the first body. The distal needle connector port of the longitudinal fluid chamber of the second body is capable of translation within the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body. The medical sealant applicator device further includes: a guide assembly. A guide assembly sets a path toward the target location and maintains the path while the needle assembly is advanced to inject the component.

[0006] In another embodiment, a method is provided that includes setting a path for a needle assembly through the pleural cavity toward a target at a known location and maintaining the path while advancing the needle assembly. The method further includes advancing the needle assembly through the pleural cavity a known distance at a first velocity. The method further includes applying a distal force to a proximal end of the needle assembly, where the force simultaneously injects the substance at a second velocity.

[0007] In another embodiment, a component delivery system includes a needle assembly, an applicator, a first body, and a second body. The needle assembly has an elongated needle with proximal and distal ends spaced apart from one another to define at least one fluid pathway therebetween. The distal end includes one or more fluid outlets coupled to the at least one fluid pathway. The applicator is fluidly coupled to the proximal end of the needle assembly. The applicator includes a first body including a first biasing assembly coupled to the needle assembly. The first body biases the needle assembly proximally relative to the applicator. The second body includes a syringe chamber having a needle connector port at a proximal end fluidly coupled to the needle assembly, and a syringe plunger disposed within the syringe chamber at a distal end and movable within the syringe chamber. A second biasing assembly is coupled between the first body and the second body, the second biasing assembly biasing the syringe plunger at the distal end of the syringe chamber.

[0008]

[0008] These and additional features provided by the embodiments described herein will be more fully understood by considering the following detailed description in conjunction with the drawings. [Brief description of the drawings]

[0009] [Figure 1]

[0009] FIG. 1 is a perspective view illustrating a component delivery system including a protective spacer according to one or more embodiments shown and described herein. [Diagram 2]

[0010] 2 is a front view of the component delivery system of FIG. 1 according to one or more embodiments shown and described herein. [Figure 3A]

[0011] FIG. 3A is a detailed view showing an ingredient delivery system along section 3A of FIG. 2 according to one or more embodiments shown and described herein. [Figure 3B]

[0012] FIG. 3B is a detailed view of the ingredient delivery system excluding selected components according to one or more embodiments shown and described herein. [Figure 4]

[0013] FIG. 2 is a perspective view of a guide assembly according to one or more embodiments shown and described herein. [Diagram 5]

[0014] FIG. 13 is a front view illustrating a threaded shaft of a guide assembly according to one or more embodiments shown and described herein. [Figure 6]

[0015] FIG. 6 is a top view of the threaded shaft of FIG. 5 according to one or more embodiments shown and described herein. [Figure 7]

[0016] FIG. 5 is a perspective view of the guide assembly of FIG. 4 excluding selected components according to one or more embodiments shown and described herein. [Figure 8]

[0017] 5 is another perspective view of the guide assembly of FIG. 4 excluding selected components according to one or more embodiments shown and described herein. [Figure 9]

[0018] 5 is another perspective view of the guide assembly of FIG. 4 excluding selected components according to one or more embodiments shown and described herein. [Figure 10]

[0019] 5 is a detailed view showing a guide assembly along section 10 of FIG. 4 according to one or more embodiments shown and described herein. [Figure 11]

[0020] FIG. 2 is a perspective view illustrating a component delivery system and guide assembly in a first position according to one or more embodiments shown and described herein. [Figure 12]

[0021] 1 is a perspective view illustrating a component delivery system and guide assembly in a second position according to one or more embodiments shown and described herein. FIG. DETAILED DESCRIPTION OF THE PREFERRED EMBODIMENTS

[0010]

[0022] Reference will now be made in detail to various embodiments of a component delivery system for administering a sealant to a subject, examples of which are illustrated in the accompanying drawings. Whenever possible, the same reference numbers will be used throughout the drawings to refer to the same or similar parts. Directional terms used herein, such as, for example, superior, inferior, right, left, front, rear, top, bottom, distal, and proximal, are made with reference only to the depicted figures and are not intended to imply absolute orientations.

[0011]

[0023] As used herein, ranges may be expressed as from "about" one particular value, and / or to "about" another particular value. When such a range is expressed, another embodiment includes from the one particular value and / or to the other particular value. Similarly, when values ​​are expressed as approximations, by use of the antecedent "about," it will be understood that the particular value forms another embodiment. It will be further understood that the endpoints of each of the ranges are significant both in relation to the other endpoint, and independently of the other endpoint.

[0012]

[0024] Unless otherwise expressly stated, no method described herein is intended to be construed as requiring that its steps be performed in a particular order, nor is it intended to require a specific orientation in any apparatus. Thus, unless a method claim actually recites an order that its steps are to be followed, unless any apparatus claim actually recites an order or orientation for individual components, unless otherwise specifically recited in the claims or this description that the steps are limited to only a particular order, or unless a specific order or orientation is recited for the components of the apparatus, no order or orientation is intended to be inferred in any respect. This applies to any possible unstated criteria of interpretation, including: logical matters related to the organization of steps, operational flow, order of components, or orientation of components; the obvious meaning derived from grammatical organization or punctuation; and the number or type of embodiments described herein.

[0013]

[0025] Unless otherwise defined, all technical and scientific terms used herein have the same meaning as commonly understood by those skilled in the art to which this disclosure belongs. The terminology used in the description of this specification is merely for describing a particular embodiment and is not intended to be limiting. As used in this specification and the appended claims, the singular forms "a", "an" and "the" are intended to include the plural forms unless the context clearly indicates otherwise.

[0014]

[0026] The terms "horizontal," "vertical," "distal," and "proximal" as used herein are merely relative terms and merely indicate a general relative orientation, not necessarily verticality. Also, these terms may be used for convenience to refer to the orientations used in the figures, which are merely used as conventions and are not intended to be characteristics of the devices shown. The present disclosure and the embodiments of the disclosure that will be described herein may be used in any desired orientation. Furthermore, horizontal and vertical walls generally only need to be intersecting walls, not necessarily vertical. The singular forms "a," "an," and "the" as used herein include plural referents unless the context clearly indicates otherwise. Thus, for example, reference to a component marked with "a" includes aspects having two or more such components, unless the context clearly indicates otherwise.

[0015]

[0027] A potential concern for medical professionals during a lung biopsy procedure is the possibility of air and / or fluid entering the pleural cavity in the lung. To mitigate this, the present disclosure is directed to a component delivery system that seals the pathway created by the needle assembly while it is penetrated into the patient. If the component delivery system uses a multi-component sealant, the component delivery system controls the flow rate of each component of the multi-component sealant so that the multi-component sealant has the proper ratio. The component delivery system may be disposed within a guide assembly. The guide assembly is disposed over the subject. The guide assembly allows the medical professional to control the height of the component delivery system and the angle of the component delivery system.

[0016]

[0028] The component delivery system has the technical effect that in response to a medical professional applying the component delivery system, a first body of the component delivery system becomes pushed towards a second body of the component delivery system. The second body contains each component of a multi-component sealant. After the second body is pushed into the first body, the components are dispensed from the first body to a mixing chamber. Within the mixing chamber, the multi-component sealant begins to mix and is dispensed from a needle assembly of the component delivery system.

[0017]

[0029] The guide assembly has the technical effect of controlling the depth and angle of the needle assembly before it is penetrated into the subject. Depth control of the guide assembly moves the needle assembly along a single direction. Angle control varies the penetration angle of the needle assembly. Adjusting the angle of the needle assembly does not affect the depth of the guide assembly. I. Ingredient Delivery Systems

[0030] 1-3B, an ingredient delivery system 100 is shown according to several embodiments. The ingredient delivery system 100 may be used during medical procedures and / or during medical research. The ingredient delivery system 100 includes an applicator 101, a mixing chamber 120, and a needle assembly 122 fluidly connected to the applicator 101.

[0018]

[0031] The applicator 101 stores the components of the multi-component sealant. In response to receiving a biasing force, the applicator 101 provides the components of the multi-component sealant to the mixing chamber 120. The applicator 101 includes a first body 103 and a second body 102. The first body 103 is disposed at a first axial end of the applicator 101 and is centered on a central axis 105 of the component delivery system 100. The second body 102 is disposed at a second axial end of the applicator 101 and is also centered on the central axis 105. As discussed herein, the first body 103 cooperates with the second body 102 to provide the components of the multi-component to the mixing chamber 120 in response to receiving a biasing force. Specifically, the biasing force results in the components of the multi-component sealant flowing from the applicator 101 to the needle assembly 122 while maintaining a controlled flow rate.

[0019]

[0032] 3B, the first body 103 includes a base 103a, a first syringe plunger 103b, a second syringe plunger 103c, a first finger projection 117a, and a second finger projection 117b. As depicted, the base 103a defines an elliptical shape, although other geometric shapes are contemplated and possible (e.g., rectangular, triangular, hexagonal). The base 103a defines a distal aperture that extends through the depth of the base 103a and is centered along the central axis 105, thereby providing a space through which the mixing chamber 120 and needle assembly 122 will extend. The base 103a may be constructed of plastic, metal, or any other suitable material.

[0020]

[0033] The first syringe plunger 103b and the second syringe plunger 103c extend from the first surface of the base 103a and are disposed on either side of the first surface of the base 103a. Each of the first syringe plunger 103b and the second syringe plunger 103c can be coupled to the base 103a (e.g., glued, fastened, plastic welded) or integrated into the base 103a (e.g., machined, molded, formed, plastic injection molding). Each of the first syringe plunger 103b and the second syringe plunger 103c can be parallel to the central axis 105.

[0021]

[0034] The first syringe plunger 103b includes a first plunger top 103d, and the second syringe plunger 103c includes a second plunger top 103e. Each plunger top 103d, 103e may be constructed of rubber, plastic, or any suitable material. The first syringe plunger 103b contacts a first component of the multi-component sealant via the first plunger top 103d, and the second syringe plunger 103c contacts a second component of the multi-component sealant via the second plunger top 103e. In response to a force being applied to the first body 103, each of the first syringe plunger 103b and the second syringe plunger 103c applies a force to a respective component of the multi-component sealant. As depicted, first syringe plunger 103b and second syringe plunger 103c are piston-type rods that define a cone-shaped top, however, any suitable syringe plunger may be utilized.

[0022]

[0035] A first finger-retaining protrusion 117a and a second finger-retaining protrusion 117b extend laterally from the first body 103 in a direction perpendicular to the central axis 105. The first finger-retaining protrusion 117a and the second finger-retaining protrusion 117b each define a curved profile. The curved profile is shaped to provide an ergonomic feel to the medical professional such that a first finger of the medical professional can apply force or hold the first finger-retaining protrusion 117a and a second finger of the medical professional can apply force or hold the second finger-retaining protrusion 117b. Although depicted as a curved profile, other geometric shapes are contemplated and possible. For example, the finger-retaining protrusions 117a, 117b can be an enclosed circle.

[0023]

[0036] The force may be applied in a proximal direction along the central axis 105 toward the second body 102. In an embodiment, the first finger retaining protrusion 117a and the second finger retaining protrusion 117b may be used to hold down (e.g., stabilize) the base 103a when applying the applicator 101. In an embodiment, three or more finger retaining protrusions are used.

[0024]

[0037] The second body 102 is disposed at an axial end of the applicator 101 opposite the first body 103. The second body 102 is disposed about a central axis 105 and may be constructed of any suitable material, such as plastic, metal, and glass.

[0025]

[0038] The second body 102 includes a first syringe barrel 104, a first U-shaped connector 106, a first longitudinal barrel 108, a second syringe barrel 110, a second U-shaped connector 112, a second longitudinal barrel 114, and an engaging element 116.

[0026]

[0039] The engaging element 116 is disposed at a second axial end of the applicator 101 and is centered about the central axis 105. As depicted, the engaging element 116 defines a flat profile, although other geometric profiles are contemplated and possible (e.g., concave profile, convex profile). The engaging element 116 is shaped to provide an ergonomic profile such that a medical professional's fingers can easily apply force to the engaging element 116 to apply force to the second body 102 along the central axis 105 toward the first body 103. Because the engaging element 116 is centered about the central axis 105 and is thereby concentric with the second body 102, a force applied to the engaging element 116 is evenly distributed relative to the second body 102. The engaging element 116 can define a plurality of ridges to assist a medical professional in engaging the engaging element 116.

[0027]

[0040] To apply the multi-component delivery system 100, a force is applied to the applicator 101. In an embodiment, a force is applied to the engagement element 116, which causes the second body 102 to translate towards the first body 103. In an embodiment, a force is applied to the first finger retention protrusion 117a and the second finger retention protrusion 117b, which causes the first body 103 to translate towards the second body 102.

[0028]

[0041] The first syringe barrel 104 contains a first component of a multi-component sealant. The first syringe barrel 104 may be translucent to allow a medical professional to view the first component, or may be opaque to protect the first component from light. The first syringe barrel 104 extends along an axis parallel to a central axis 105.

[0029]

[0042] The first syringe plunger 103b extends into a first syringe aperture 104a of the first syringe barrel 104. The first syringe plunger 103b and the first syringe aperture 104a are cooperatively sized such that a first plunger top 103d of the first syringe plunger 103b creates an airtight seal within the first syringe barrel 104. This airtight seal prevents the first component located within the first syringe barrel 104 from leaking out of the first syringe barrel 104 and exposing the first component to the atmosphere. The inner diameter of the first syringe barrel 104 can be adjusted to control the rate at which the component exits the first syringe barrel 104 during application (in other words, the flow rate). For example, if the ratio to create a multi-component seal requires an additional amount of the first component, the inner diameter of the first syringe barrel 104 may be enlarged. Additionally, if the ratio to create a multi-component seal requires a smaller amount of the first component, the inner diameter of the first syringe barrel 104 may be reduced.

[0030]

[0043] In response to the application of a force against the applicator 101, a biasing force is applied against the first component in the first syringe barrel 104 via the first syringe plunger 103b. In other words, in response to the engagement element 116 being pushed toward the first body 103 and / or the finger retention protrusions 117a, 117b being pushed toward the second body 102, the first syringe plunger 103b translates within the first syringe barrel 104 toward the second body 102. The first syringe plunger 103b can then push the first component in the first syringe barrel 104 out of the first syringe barrel 104.

[0031]

[0044] The first syringe barrel 104 is coupled to and fluidly connected with the first u-shaped connector 106. The first u-shaped connector 106 extends laterally (e.g., perpendicular to the central axis 105) from the first syringe barrel 104 toward the central axis 105. In an embodiment, the first u-shaped connector 106 is integrated into the first syringe barrel 104. In response to the first component exiting the first syringe barrel 104 via the first syringe plunger 103b, the first component is fluidly provided to the first u-shaped connector 106. By defining a u-shaped fluid path, the first component is redirected from movement toward the second body 102 (e.g., within the first syringe barrel 104) to movement toward the first body 103 (e.g., after exiting the first u-shaped connector 106). The curved shape of the first u-shaped connector 106 prevents a bottleneck from forming in the fluid path, thereby allowing a constant flow rate of fluid to exit the applicator 101. As the first component continues to travel, it is able to exit the first u-shaped connector 106.

[0032]

[0045] The first u-shaped connector 106 may be coupled to the first longitudinal barrel 108 for fluid communication. In an embodiment, the first u-shaped connector 106 is integral to the first longitudinal barrel 108. The first longitudinal barrel 108 may extend along an axis parallel to the first syringe barrel 104 and the central axis 105. By defining a longitudinal profile parallel to the central axis 105, the first component is directed towards the first body 103. The first longitudinal barrel 108 may be constructed of plastic, glass, or any other suitable material.

[0033]

[0046] The second syringe barrel 110 contains the second component of the multi-component sealant. The second syringe barrel 110 may be translucent to allow a medical professional to view the second component, or may be opaque to protect the second component from light. The second syringe barrel 110 extends along an axis parallel to the central axis 105.

[0034]

[0047] The second syringe plunger 103c extends into the second syringe aperture 110a of the second syringe barrel 110. The second syringe plunger 103c and the second syringe aperture 110a are cooperatively sized such that the second plunger top 103e of the second syringe plunger 103c creates an airtight seal within the second syringe barrel 110. This airtight seal prevents the second component located within the second syringe barrel 110 from leaking out of the second syringe barrel 110 and exposing the second component to the atmosphere. The inner diameter of the second syringe barrel 110 can be adjusted to control the rate at which the components exit the second syringe barrel 110 during application. For example, if the ratio to create a multi-component seal requires an additional amount of the second component, the inner diameter of the second syringe barrel 110 can be enlarged. Additionally, if the ratio requires a smaller amount of the second component to create a multi-component seal, the inner diameter of the second syringe barrel 110 may be reduced.

[0035]

[0048] In response to the application of a force against the applicator 101, a biasing force is applied against the second component in the second syringe barrel 110 via the second syringe plunger 103c. In other words, in response to the engagement element 116 being pushed toward the first body 103 and / or the finger retention protrusions 117a, 117b being pushed toward the second body 102, the second syringe plunger 103c translates within the second syringe barrel 110 toward the second body 102. The second syringe plunger 103c can then push the second component in the second syringe barrel 110 out of the second syringe barrel 110.

[0036]

[0049] The second syringe barrel 110 is coupled to and fluidly connected with the second u-shaped connector 112. The second u-shaped connector 112 extends laterally (e.g., perpendicular to) the central axis 105 from the second syringe barrel 110. In an embodiment, the second u-shaped connector 112 is integrated into the second syringe barrel 110. In response to the second component exiting the second syringe barrel 110 via the second syringe plunger 103c, the second component is fluidly provided to the second u-shaped connector 112. Defining a u-shaped fluid path redirects the second component from movement toward the second body 102 (e.g., within the second syringe barrel 110) to now movement toward the first body 103 (e.g., after exiting the second u-shaped connector 112). The curved shape of the second u-shaped connector 112 prevents a bottleneck from forming in the fluid path, thereby allowing a constant flow rate of fluid to exit the applicator 101. As the second component continues to travel, it is able to exit the second u-shaped connector 112.

[0037]

[0050] The second u-shaped connector 112 may be coupled to and fluidly connected with the second longitudinal barrel 114. In an embodiment, the second u-shaped connector 112 is integral with the second longitudinal barrel 114. The second longitudinal barrel 114 may extend along an axis parallel to the second syringe barrel 110 and the central axis 105. By defining a longitudinal profile parallel to the central axis 105, the second component is directed towards the first body 103. The second longitudinal barrel 114 may be constructed of plastic, glass, or any other suitable material.

[0038]

[0051] 3A-3B, the mixing chamber 120 is shown disposed between the base 130a and the first longitudinal barrel 108 and the second longitudinal barrel 114. The mixing chamber 120 may be centrally disposed along the central axis 105.

[0039]

[0052] As depicted, the sidewalls for the mixing chamber 120 define an inwardly tapered profile, such that the mixing inlet 120a defines a larger area than the mixing outlet 120b. In this way, the first and second components received by the first and second longitudinal barrels 108 and 114, respectively, begin to interface with each other while minimizing the chance of bottlenecks occurring within the mixing chamber 120. However, other shapes are contemplated and possible. For example, in embodiments, the area of ​​the mixing outlet 120b may be greater than or equal to the area of ​​the mixing inlet 120a. In these embodiments, the sidewalls of the mixing chamber 120 may define an outwardly tapered profile or may be parallel. The mixing chamber 120 may be constructed of any suitable material, such as plastic, ceramic, glass, metal, or any other suitable material.

[0040]

[0053] The first longitudinal barrel 108 and the second longitudinal barrel 114 are fluidly coupled to a mixing inlet 120a of a mixing chamber 120. In response to the first component moving within the first longitudinal barrel 108 and the second component moving within the second longitudinal barrel 114, the first component and the second component are provided to the mixing inlet 120a of the mixing chamber 120. Thus, within the mixing chamber 120, the first component and the second component can come into interfacial contact and begin to mix.

[0041]

[0054] In an embodiment, the first component and the second component do not mix in the mixing chamber 120. In an embodiment, the first component and the second component begin to mix and form the multi-component sealant in the mixing chamber 120. In an embodiment, the first component and the second component mix completely in the mixing chamber 120, thereby forming the multi-component sealant.

[0042]

[0055] In embodiments, the component delivery system 100 does not include a mixing chamber 120. In these embodiments, the first longitudinal barrel 108 and the second longitudinal barrel 114 are integrated such that the first component and the second component are in interfacial contact within the combined first longitudinal barrel 108 and second longitudinal barrel 114. Continuing with these embodiments, the first longitudinal barrel 108 and / or the second longitudinal barrel 114 define a helical profile (not shown) for interfacially contacting the first component with the second component and vice versa.

[0043]

[0056] 1, the ingredient delivery system 100 is shown with a removable stop 118. The removable stop 118 can be assembled to the ingredient delivery system 100 by a medical professional to prevent unintended application of the applicator 101. The removable stop 118 is assembled to the applicator 101 between the first body 103 and the second body 102, thereby preventing the second body 102 from translating toward the first body 103. The removable stop 118 can be placed on the applicator 101 until the medical professional is ready to utilize the ingredient delivery system 100. In an embodiment, the removable stop 118 is integrated (e.g., molded, cast) into the ingredient delivery system 100 and includes a removable tab to allow easy disassembly of the removable stop 118 from the ingredient delivery system 100. The removable stop 118 can be constructed of plastic, ceramic, metal, or any suitable material.

[0044]

[0057] The removable stop 118 can include a first stop element 118a and a second stop element 118b. When the removable stop 118 is assembled to the applicator 101, the first stop element 118a is disposed on the first syringe plunger 103b and is disposed between the base 103a and the first syringe barrel 104. Additionally, the second stop element 118b is disposed on the second syringe plunger 103c and is disposed between the base 103a and the second syringe barrel 110. In an embodiment, each stop element 118a, 118b can be removably coupled to each syringe barrel 104, 110 via a snap-fit ​​connection or any suitable similar connection. In this way, the removable stop 118 prevents movement of the second body 102 towards the first body 103 due to physical interference by the first stop element 118a and the second stop element 118b. The removable stop 118 may then be removed when it is intended to use the component delivery system 100. In an embodiment, the removable stop 118 may include only one of the first stop element 118a or the second stop element 118b.

[0045]

[0058] Referring to FIG. 2, a needle assembly 122 is shown including a connector hub 122a and an elongated needle 122b. The needle assembly 122 is centrally disposed along the central axis 105 and extends along the central axis 105. The needle assembly 122 dispenses the multi-component sealant from the applicator 101 to a target location in a subject. The needle assembly 122 is disposed at an axial end of the component delivery system 100 opposite the opposite axial end of the component delivery system 100 (e.g., where the engagement element 116 is disposed). The needle assembly 122 can be any available needle assembly used in medical applications. The needle assembly 122 begins to dispense the multi-component sealant while the needle assembly 122 enters the target location in the subject.

[0046]

[0059] A connector hub 122a is coupled to and fluidly connected with the mixing outlet 120b. The connector hub 122a is disposed about a central axis 105. As depicted, the connector hub 122a is embedded within the mixing outlet 120b. However, other fastening methods, such as fastening screws, adhesives, etc., may be utilized to couple the connector hub 122a to the mixing outlet 120b. In an embodiment, the connector hub 122a is integrated (e.g., cast, formed, machined, molded) into the mixing chamber 120. As the first component, second component, and / or multi-component sealant continue to move, the first component, second component, and / or multi-component sealant exits the mixing outlet 120b and enters the connector hub 122a. In an embodiment, the first component and the second component may begin to mix or continue to mix within the connector hub 122a.

[0047]

[0060] An elongated needle 122b is coupled to and fluidly connected with the connector hub 122a. The elongated needle 122b is disposed about and extends along the central axis 105. In an embodiment, the connector hub 122a may be integral to the connector hub 122a. In an embodiment, the elongated needle 122b receives the thoroughly mixed multi-component sealant from the connector hub 122a. In an embodiment, the first component and the second component may begin to mix or continue to mix within the elongated needle 122b.

[0048]

[0061] The elongated needle 122b defines a needle outlet 122c. The needle outlet 122c is disposed at an axial end of the elongated needle 122b opposite the connector hub 122a. A multi-component sealant is dispensed from the elongated needle 122b via the needle outlet 122c to a target location within the subject.

[0049]

[0062] The component delivery system 100 delivers the multi-component sealant to the subject while a needle assembly of the component delivery system 100 is penetrated into the pleural cavity of the subject's lung. In this way, the medical professional seals the passage of the needle assembly during needle penetration. Each component of the multi-component sealant exits a respective syringe barrel in response to the component delivery system 100 receiving an applied force while the needle assembly 122 is being penetrated into the pleural cavity of the subject's lung. The components of the multi-component sealant are then mixed within the component delivery system 100, thereby forming the multi-component sealant. The multi-component sealant is then dispensed from the needle assembly 122.

[0050]

[0063] In this manner, configuration of the component delivery system 100 to provide a controlled ratio of each component allows for the use of a multi-component sealant, which is advantageous because the multi-component sealant may be superior to a single-component sealant in providing a seal. Additionally, the rate of delivery of the component delivery system 100 may be controllably dispensed, which is advantageous because it reduces the likelihood that a medical professional will apply too much or too little sealant to a subject. II. Guide System

[0064] 11-12, there is shown a system 400 having a component delivery system 100 and a guide assembly 420. Although depicted with component delivery system 100, any syringe assembly and / or needle assembly may be used with guide assembly 420.

[0051]

[0065] The component delivery system 100 is disposed within the guide assembly 420. The guide assembly 420 is disposed about the guide axis 401 a. When a medical professional is ready to dispense the multi-component sealant to a subject during a medical procedure and / or medical study, the guide assembly 420 is placed on the subject's skin so that the needle assembly 122 can enter the skin and translate toward the target treatment area.

[0052]

[0066] The guide assembly 420 allows the medical professional to control the placement of the component delivery system 100 prior to injecting the multi-component sealant. The medical professional can use the guide assembly 420 to control the depth of the component delivery system 100, such that the medical professional can determine the desired depth adjustment of the needle assembly 122 prior to entry into the subject. The component delivery system 100 defines a central axis 105. The guide assembly 420 allows for depth adjustment of the component delivery system 100 along the central axis 105.

[0053]

[0067] The medical professional can further use the guide assembly 420 to determine the angle of the component delivery system 100, thereby allowing the medical professional to control the entry angle 401c of the needle assembly 122 prior to entry into the subject. The entry angle 401c can be defined by comparing the deviation of the central axis 105 from the guide axis 401a. As depicted in FIG. 4, the entry angle 401c of the component delivery system 100 is depicted as being in a first position of the system 400. As depicted in FIG. 5, the guide assembly 420 is in a second position after being adjusted to achieve a different entry angle 401c.

[0054]

[0068] Continuing with reference to FIGS. 11-12, the base 103a defines a base surface 103f. As discussed in more detail herein, the guide assembly 420 includes a depth adjustment component, an angle adjustment component, and a base 432. The depth adjustment component includes a threaded shaft 422. The threaded shaft 422 includes a first shaft surface 422a, a threaded portion 422b, a shaft outlet 422c, and a second shaft surface 422d (shown in FIGS. 5-6). The component delivery system 100 is removably coupled to the guide assembly 420 by contacting the base 103a with the first shaft surface 422a of the threaded shaft 422. The base surface 103f can define a flat profile, although other shapes are contemplated and possible. For example, the base surface 103f can have a protruding profile, and the first shaft surface 422a can be shaped and sized to define a receiving cavity for receiving the protruding profile.

[0055]

[0069] In an embodiment, the base surface 103f includes an engagement element (e.g., a snap-fit ​​connection, fastener) for releasably securing the component delivery system 100 to the guide assembly 420. In this way, the component delivery system 100 is better positioned within the guide assembly 420 to minimize unintended movement (e.g., loosening) within the system 400. This is advantageous because it provides better control by the medical professional using the system 400 prior to injecting the multi-component sealant into a subject during a procedure.

[0056]

[0070] When the component delivery system 100 is disposed within the guide assembly 420, the needle assembly 122 of the component delivery system 100 extends along a portion of the threaded shaft 422 and subsequently out of the shaft outlet 422c.

[0057]

[0071] 4, the depth adjustment components of the guide assembly 420 include a threaded shaft 422, a collar 424, and a shaft platform (or platform) 426. The angle adjustment components of the guide assembly 420 include an arcuate platform 427, a first guide member 428, and a second guide member 430.

[0058]

[0072] The threaded shaft 422 provides depth adjustment for the guide assembly 420. As discussed above, the threaded shaft 422 includes a first shaft surface 422a, a threaded portion 422b, a shaft exit 422c, and a second shaft surface 422d. The second shaft surface 422d is disposed opposite the first shaft surface 422a on the shaft head of the threaded shaft 422. As depicted, the threaded portion 422b defines an externally disposed thread. In an embodiment, the threaded portion 422b defines an internal thread. The threaded shaft 422 may be constructed of metal or plastic, or the like. The shaft exit 422c is sized to allow for the utilization of a variety of needle assembly gauges.

[0059]

[0073] 7-9, the collar 424 includes a first collar surface 424a, an internal thread 424b, a sleeve 424c, and a second collar surface 424d. The first collar surface 424a is disposed opposite the second collar surface 424d. When the threaded shaft 422 is assembled to the collar 424, the second shaft surface 422d contacts the first collar surface 424a. At a desired depth position, the threaded portion 422b of the threaded shaft 422 can engage with the internal thread 424b of the collar 424. At this time, the internal thread 424b of the collar 424 can lock (in other words, fix) the threaded shaft 422 in a fixed position. In addition, the internal thread 424b allows fine adjustment of the threaded shaft 422 by fastening the threaded shaft 422 along the central axis 105.

[0060]

[0074] This may allow the medical professional to adjust the depth placement of the component delivery system 100 by first sliding the threaded shaft 422 within the collar 424 in the adjustment position and then engaging the internal threads 424b of the collar 424 with the threads 422b of the threaded shaft 422 in the lock position. Additionally, the medical professional may make fine adjustments by tightening the threaded shaft 422 along the central axis 105. The depth of the needle assembly 122 relative to the subject's skin is maintained regardless of adjustments made to achieve the desired penetration angle 401c. In embodiments where the threads 422b of the threaded shaft 422 are located on the inside, the threads of the collar 424 may be located on the exterior surface of the collar 424.

[0061]

[0075] The shaft platform 426 includes a shaft surface 426a, an engagement tab 426b, a slot 426c, and a shaft outer surface 426d. The shaft platform 426 is partially disposed within a sleeve 424c of the collar 424 and is coupled to the collar 424. In an embodiment, the collar 424 is integral to the shaft platform 426. When the threaded shaft 422 is disposed within the collar 424, the threaded shaft 422 is simultaneously disposed within the slot 426c of the shaft platform 426. The slot 426c extends through the depth of the shaft platform 426. The inner diameter of the slot 426c is shaped and sized to exceed the outer diameter of the threaded portion 422b of the threaded shaft 422. This allows the threaded shaft 422 to be slidably movable along the length of the shaft platform 426 and the collar 424 before engaging the internal threads 424b of the collar 424. This is advantageous because it allows for large depth adjustments to be made without having to fully clamp or unclamp the threaded shaft 422 along the central axis 105. As depicted, the shaft outer surface 426d of the shaft platform 426 is circular, although other geometric profiles are contemplated and possible.

[0062]

[0076] The arcuate platform 427 includes an engagement slot 427a, an arcuate surface 427b, and an arcuate rail 427c. The arcuate platform 427 surrounds an outer edge of the threaded portion 422b of the threaded shaft 422. The engagement slot 427a is formed in the arcuate surface 427b. The engagement tabs 426b of the shaft platform 426 connect the shaft platform 426 to the arcuate platform 427 via the engagement slots 427a. The arcuate rails 427c are disposed on either side of the arcuate surface 427b and extend at least partially along either side of the arcuate surface 427b.

[0063]

[0077] In response to a force being applied to the arcuate rail 427c, the arcuate platform 427 moves accordingly in the direction of the applied force. Because the arcuate platform 427 is coupled to the shaft platform 426, this force causes the shaft platform 426 and collar 424 to translate. This causes the component delivery system 100 disposed within the shaft platform 426 and collar 424 to translate.

[0064]

[0078] 4, there is shown a first guide member 428 and a second guide member 430. The first guide member 428 and the second guide member 430 allow for adjustment of the entry angle 401c of the component delivery system 100. The first guide member 428 and the second guide member 430 cooperate to achieve the entry angle 401c by being each capable of rotating about an axis of rotation.

[0065]

[0079] A first end 428a of the first guide member 428 is coupled to a first side 432a of the base 432. A second end 428b of the first guide member 428 is coupled to a second side 432b of the base 432. The first side 432a of the base 432 and the second side 432b of the base 432 are disposed at opposite positions of the base 432.

[0066]

[0080] The first guide member 428 defines an arcuate profile between the first end 428a and the second end 428b. A first intermediate portion 428d of the first guide member 428 is disposed between the first end 428a and the second end 428b. The first intermediate portion 428d contacts the arcuate surface 427b of the arcuate platform 427. Additionally, the first intermediate portion 428d contacts the arcuate rail 427c of the arcuate platform 427. The first guide member 428 rotates about a first axis of rotation that is perpendicular to the length of the first guide member 428 in response to receiving a force.

[0067]

[0081] To adjust the entry angle 401c of the component delivery system 100, a medical professional can apply a force to any of the components of the component delivery system 100 or the guide assembly 420. When the components of the guide assembly 420 are coupled together, the input force is ultimately transferred to the arcuate rail 427c of the arcuate platform 427. The force applied to the arcuate rail 427c is transferred onto the first intermediate portion 428d of the first guide member 428. In response to receiving this force on the first intermediate portion 428d, the first guide member 428 can rotate about a first axis of rotation. The first guide member 428 can be constructed of plastic, metal, or any other suitable material.

[0068]

[0082] A first end 430a of the second guide member 430 is coupled to a third side 432c of the base 432. A second end 430b of the second guide member 430 is coupled to a fourth side 432d of the base 432. The third side 432c of the base 432 and the fourth side 432d of the base 432 are disposed at opposite positions of the base 432.

[0069]

[0083] The second guide member 430 defines an arcuate profile between the first end 430a and the second end 430b. The second intermediate portion 430d of the second guide member 430 is disposed between the first end 430a and the second end 430b. The second intermediate portion 430d of the second guide member 430 contacts the second collar surface 424d of the collar 424. Additionally, the first intermediate portion 428d contacts the shaft outer surface 426d of the shaft platform 426. The second guide member 430 rotates about a second axis of rotation that is perpendicular to the length of the second guide member 430 in response to receiving a force.

[0070]

[0084] To adjust the entry angle 401c of the component delivery system 100, a medical professional can apply force to any of the components of the component delivery system 100 or the guide assembly 420. When the components of the guide assembly 420 are coupled together, the input force is ultimately transferred to the shaft outer surface 426d of the shaft platform 426. The force applied to the shaft outer surface 426d is transferred onto the second intermediate portion 430d of the second guide member 430. In response to receiving this force on the second intermediate portion 430d, the second guide member 430 can rotate about a second axis of rotation. The second guide member 430 can be constructed of plastic, metal, or any other suitable material.

[0071]

[0085] The first guide member 428 and the second guide member 430 cooperate to adjust the penetration angle 401c of the component delivery system 100. The first guide member 428 is adjusted on a first axis of rotation, and the second guide member 430 is adjusted on a second axis of rotation. Thus, a medical professional can move the first guide member 428 and / or the second guide member 430 to achieve a desired penetration angle 401c of the component delivery system 100. Adjustment of either the first guide member 428 or the second guide member 430 does not change the depth of the threaded shaft 422. In this way, a medical professional has improved control of the penetration of the needle assembly 122 of the component delivery system 100, with both depth and angle control.

[0072]

[0086] 10, detailed portions of the base 432 and the second guide member 430 are shown. Specifically, the third side 432c of the base 432 and the first end 430a of the second guide member 430 are shown. As shown, the shaft 434 of the first end 430a of the second guide member 430 extends through an aperture in the third side 432c and is coupled to an aperture in the third side 432c. The first end 430a is coupled to the third side 432c through an interference fit. In other words, the third side 432c secures the shaft 434 through friction. The third side 432c and the shaft 434 are shaped and sized such that the position of the first guide member 428 is stationary when the component delivery system 100 is in use or when the depth of the threaded shaft 422 is being adjusted.

[0073]

[0087] The third side 432c and the shaft 434 are further shaped and sized to adjust in response to the first guide member 428 being subjected to a force having a rotational direction. The second side 432b of the second guide member 430 and the first and second ends 428a, 428b of the first guide member 428 are shaped and sized in a manner similar to the manner of the first side 432a of the second guide member 430. Thus, the first and second ends 428a, 428b of the first guide member 428 and the first and second ends 430a, 430b of the second guide member 430 may each include a shaft 434 disposed within a respective base end.

[0074]

[0088] Thus, the first side 432a, the second side 432b, and the fourth side 432d of the base 432 are shaped and sized similarly to the third side 432c.

[0089] The base 432 is centered on the guide shaft 401a and placed on the subject. The base 432 may be constructed of any suitable material for medical applications, such as plastic, metal, and the like. As depicted, the base 432 defines a disk geometry. However, other geometries are contemplated and possible. For example, the base 432 may define a curved profile, such that the base 432 may be better applied onto a curved surface of the subject (e.g., the subject's arm, the subject's leg). The base 432 defines a central aperture, such that the needle assembly 122 of the component delivery system 100 may contact the subject's skin.

[0075]

[0090] Disclosed herein is a component delivery system having a first body and a second body containing each component of a multi-component sealant. When an engagement element of the component delivery system is applied, the first body is moved toward the second body. This causes each component to be dispensed from the first body to a mixing chamber. In the mixing chamber, the multi-component sealant begins to mix and is then dispensed from a needle assembly of the component delivery system.

[0076]

[0091] Further disclosed herein is a guide assembly that can be used with the component delivery system or any other syringe / needle assembly. The guide assembly can control the depth and angle of the component delivery system prior to insertion into the subject. The depth control of the guide assembly moves the component delivery system along a single direction, while the angle control controls the entry angle of the component delivery system. The guide assembly is capable of adjusting the angle of the component delivery system without affecting the depth of the component delivery system.

[0077]

[0092] In summary, the present disclosure may be considered to relate to the following aspects: In a first aspect, a medical sealant applicator device for delivery of a multi-component sealant comprises a first body and a second body. The first body has a base, a first syringe plunger, a second syringe plunger, and a longitudinal channel interposed laterally between the first and second syringe plungers. Each of the first and second syringe plungers is oriented to extend in a first direction from the base. The first syringe plunger has a first free end having a first proximal plunger piston. The second syringe plunger has a second free end having a second proximal plunger piston. A second body of the medical sealant application device has a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber interposed laterally between the first and second syringe chambers. The longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is in fluid communication with each of the first and second syringe chambers. The distal end of the longitudinal fluid chamber has a distal needle connector port. The first syringe chamber of the second body has a first distal opening for slidably receiving a first proximal plunger piston of a first syringe plunger of the first body. A second syringe chamber of the second body has a second distal opening for slidably receiving a second proximal plunger piston of a second syringe plunger of the first body, and a distal needle connector port of the longitudinal fluid chamber of the second body is capable of translation within the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body.

[0078]

[0093] In a second aspect considering the first aspect, when a force is applied in a distal direction to the proximal ends of the first and second syringe barrels, the force simultaneously overcomes the biasing force of the first biasing assembly of the first body and the second biasing assembly of the medical sealant applicator device, causing the first and second syringe plungers to move in a proximal direction relative to the first and second syringe barrels and the elongated needle to move distally away from the base in a distal direction opposite the proximal direction.

[0079]

[0094] In a third aspect or second aspect considering the first aspect, the base of the first body includes a distal aperture, the longitudinal channel extends in a first direction from the distal aperture, and the medical sealant applicator device further includes a needle assembly having a connector hub and an elongated needle extending from the connector hub, the connector hub is removably coupled to a distal needle connector port of the second body, and the elongated needle extends from the second body through the distal aperture of the base of the first body.

[0080]

[0095] In a fourth aspect according to any one of the above aspects, the second body comprises: a first U-shaped connector fluidly connecting a proximal end of the longitudinal fluid chamber to the first syringe chamber; and a second U-shaped connector fluidly connecting a proximal end of the longitudinal fluid chamber to the second syringe chamber.

[0081]

[0096] In a fifth aspect according to any one of the first to fourth aspects, the medical sealant applicator device includes: a pair of finger retention projections extending laterally from a base of the first body.

[0082]

[0097] In a sixth aspect according to any one of the first to fifth aspects, the medical sealant applicator device comprises: a guide assembly for setting the depth of advancement of the elongate needle.

[0083]

[0098] In a seventh aspect, a medical sealant applicator device for delivery of a multi-component sealant comprises: a first body, a second body, and a guide assembly. The first body has a base, a first syringe plunger, a second syringe plunger, and a longitudinal channel interposed laterally between the first and second syringe plungers. Each of the first and second syringe plungers is oriented to extend in a first direction from the base. The first syringe plunger has a first free end having a first proximal plunger piston. The second syringe plunger has a second free end having a second proximal plunger piston. The second body has a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber interposed laterally between the first and second syringe chambers. The longitudinal fluid chamber has a proximal end and a distal end. The proximal end of the longitudinal fluid chamber is fluidly connected to each of the first and second syringe chambers. The distal end of the longitudinal fluid chamber has a distal needle connector port. The first syringe chamber of the second body has a first distal opening for slidably receiving a first proximal plunger piston of a first syringe plunger of the first body. The second syringe chamber of the second body has a second distal opening for slidably receiving a second proximal plunger piston of a second syringe plunger of the first body. The distal needle connector port of the longitudinal fluid chamber of the second body is capable of translation within the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body. A guide assembly sets a path toward the target location and maintains the path while the needle assembly is advanced to inject the component.

[0084]

[0099] In an eighth aspect according to the seventh aspect, when a force is applied in a distal direction to the proximal ends of the first syringe barrel and the second syringe barrel, the force overcomes the biasing forces of the first biasing assembly of the first body and the second biasing assembly of the second body simultaneously, causing the first syringe plunger and the second syringe plunger to move in a proximal direction relative to the first syringe barrel and the second syringe plunger and causing the elongated needle to move distally away from the base in a distal direction opposite the proximal direction.

[0085]

[0100] In a ninth aspect according to the seventh or eighth aspect, the base of the first body includes a distal aperture, the longitudinal channel extends in a first direction from the distal aperture, and the medical sealant applicator device further includes a needle assembly having a connector hub and an elongated needle extending from the connector hub, the connector hub is removably connected to the distal needle connector port of the second body, and the elongated needle extends from the second body through the distal aperture of the base of the first body.

[0086]

[0101] In a tenth aspect according to any one of the seventh to ninth aspects, the second body includes a first U-shaped connector fluidically connecting a proximal end of the longitudinal fluid chamber to the first syringe chamber, and a second U-shaped connector fluidically connecting a proximal end of the longitudinal fluid chamber to the second syringe chamber.

[0087]

[0102] In an eleventh aspect according to any one of the seventh to tenth aspects, a pair of finger projections extend laterally from a base of the first body.

[0103] In a twelfth aspect according to any one of the seventh to eleventh aspects, a guide assembly sets the depth of advancement of the elongate needle.

[0088]

[0104] In a thirteenth aspect, a method includes setting a path for a needle assembly toward a target at a known distance through the pleural cavity and maintaining the path while advancing the needle assembly. The method further includes advancing the needle assembly the known distance through the pleural cavity at a first velocity. The method further includes applying a distal force to a proximal end of the needle assembly, the force simultaneously injecting the substance at a second velocity.

[0089]

[0105] In a fourteenth aspect according to the thirteenth aspect, the advancing of the needle assembly is simultaneous with the application of the force.

[0106] In a fifteenth aspect according to the thirteenth or fourteenth aspect, a first speed of the needle assembly is correlated to a second speed of injecting the substance.

[0090]

[0107] In a sixteenth aspect according to the fifteenth aspect, a correlation of the first speed of the needle assembly to the second speed of injecting the substance is modifiable.

[0108] In a seventeenth aspect according to any one of the thirteenth to sixteenth aspects, the guide assembly advances the needle assembly further into the lungs of the subject.

[0091]

[0109] In an eighteenth aspect, a component delivery system includes a needle assembly, an applicator, a first body, and a second body. The needle assembly has an elongated needle with proximal and distal ends spaced apart from one another to define at least one fluid pathway therebetween. The distal end includes one or more fluid outlets coupled to the at least one fluid pathway. The applicator is fluidly coupled to the proximal end of the needle assembly. The applicator includes a first body including a first biasing assembly coupled to the needle assembly. The first body biases the needle assembly proximally relative to the applicator. The second body includes a syringe chamber having a needle connector port at a proximal end fluidly coupled to the needle assembly, and a syringe plunger disposed within the syringe chamber at a distal end and movable within the syringe chamber. A second biasing assembly is coupled between the first body and the second body, the second biasing assembly biasing the syringe plunger at the distal end of the syringe chamber.

[0092]

[0110] In a 19th aspect according to the 18th aspect, when a force is applied to the proximal end of the syringe chamber in a distal direction, the force overcomes the biasing forces of the first biasing assembly and the second biasing assembly simultaneously, causing the syringe plunger to move in a proximal direction relative to the syringe chamber and the needle assembly to move distally away from the first body in a distal direction opposite the proximal direction.

[0093]

[0111] In a twentieth aspect according to the eighteenth or nineteenth aspects, the needle assembly further includes a connector hub removably connected to the needle connector port, and the elongated needle extends from the second body through the first body.

[0094]

[0112] In a twenty-first aspect according to any one of the eighteenth to twentieth aspects, the first body includes a pair of finger holding protrusions extending laterally from the first body.

[0113] In a twenty-second aspect according to any one of the eighteenth to twenty-first aspects, the device includes a guide assembly for setting the depth of advancement of the elongate needle.

[0095]

[0114] In a twenty-third aspect according to any one of the eighteenth to twenty-second aspects, the method further includes a guide assembly, the guide assembly comprising a depth adjustment component, a base and an angle adjustment component, the depth adjustment component comprising: a threaded shaft with a shaft head having a first shaft surface and a second shaft surface opposite the first shaft surface, the first shaft surface contacting the component delivery system, a collar with an internal thread that is threadedly engaged with the threaded shaft in a locked setting and a slot that allows translation of the threaded shaft along a central axis of the guide assembly in an adjusted setting, a shaft platform that contacts the second shaft surface of the shaft head, and an arcuate platform coupled to the shaft platform. The angle adjustment component includes a first guide member having a first end connected to the base, a second end connected to the base, and a first intermediate portion between the first and second ends, where the first intermediate portion is disposed a distance from the base and contacts the arcuate platform; and a second guide member having a first end connected to the base, a second end connected to the base, and a second intermediate portion between the first end of the second guide member and the second end of the second guide member, where the second intermediate portion is disposed a distance from the base and contacts the shaft platform.

[0096]

[0115] In a twenty-fourth aspect according to the twenty-third aspect, the threaded shaft is movable along the central axis while at the adjustment setting.

[0116] In a twenty-fifth aspect according to the twenty-third aspect, the depth adjustment component is movably connected to the first guide member along a first rotational axis, and the second guide member is movably connected along a second rotational axis that is perpendicular to the first rotational axis.

[0097]

[0117] In a twenty-sixth aspect according to any one of the twenty-third to twenty-fifth aspects, the threaded shaft further includes a threaded portion defining an outer diameter, and the slot defines an inner diameter larger in size than the outer diameter.

[0098]

[0118] In a twenty-seventh aspect according to any one of the twenty-third to twenty-sixth aspects, the elongated needle is disposed within the shaft outlet of the threaded shaft.

[0119] In a 28th aspect according to any one of the 23rd to 26th aspects, the first end and the second end are rotatably connected to the base, thereby facilitating rotation of the first guide member relative to the base.

[0099]

[0120] In a 29th aspect according to any one of the 23rd to 28th aspects, a first end of the second guide member and a second end of the second guide member are rotatably connected to a base, thereby facilitating rotation of the second guide member relative to the base.

[0100]

[0121] In a 30th aspect according to any one of the 23rd to 29th aspects, the first intermediate portion and the second intermediate portion are disposed between a surface of the shaft platform and a surface of the arcuate platform.

[0101]

[0122] In a 31st aspect according to any one of the 23rd to 30th aspects, the base further includes a first side and a second side directly opposite the first side; a third side and a fourth side directly opposite the third side; the first side is connected to a first end of the first guide member; the second side is connected to a second end of the first guide member; the third side is connected to a first end of the second guide member; and the fourth side is connected to a second end of the second guide member.

[0102]

[0123] In a thirty-second aspect, a device includes a needle assembly that is routed through the pleural cavity toward a target a known distance and maintains the route during advancement of the needle assembly. The needle assembly is advanced through the pleural cavity a known distance at a first velocity. A force is applied to the proximal end of the needle assembly in a distal direction that simultaneously injects a substance at a second velocity.

[0103]

[0124] For purposes of describing and defining this disclosure, it is noted that the term "substantially" is used herein to represent the inherent degree of uncertainty that may be imparted to any quantitative comparison, value, measurement, or other representation. The term "substantially" is also used herein to represent the degree to which a quantitative representation may vary from the stated standard without leading to a change in the basic functionality of the subject matter at issue. Thus, the term "substantially" is used to represent the inherent degree of uncertainty that may be imparted to any quantitative comparison, value, measurement, or other representation, with reference to a configuration of elements or features that may embody what would be expected to theoretically exhibit an exact correspondence or behavior, but which falls just short of exactness in practice.

[0104]

[0125] Although specific embodiments have been shown and described herein, it will be understood that various other changes and modifications can be made without departing from the spirit and scope of the claimed subject matter. Moreover, although various aspects of the claimed subject matter have been described herein, such aspects do not necessarily have to be utilized in combination. Accordingly, the appended claims are intended to cover all changes and modifications that are within the scope of the claimed subject matter.

Claims

1. 1. A medical sealant applicator device for delivery of a multi-component sealant, comprising a first body and a second body, the first body comprising: a first syringe plunger, a second syringe plunger, and a longitudinal channel interposed laterally between the first and second syringe plungers, each of the first and second syringe plungers oriented to extend in a first direction from the base, the first syringe plunger having a first free end having a first proximal plunger piston, and the second syringe plunger having a second free end having a second proximal plunger piston; and the second body comprising: a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber interposed laterally between the first syringe chamber and the second syringe chamber, the longitudinal fluid chamber having a proximal end and a distal end, the proximal end of the longitudinal fluid chamber being fluidly connected to each of the first syringe chamber and the second syringe chamber, and the distal end of the longitudinal fluid chamber having a distal needle connector port; the first syringe chamber of the second body having a first distal opening for slidably receiving the first proximal plunger piston of the first syringe plunger of the first body; the second syringe chamber of the second body having a second distal opening for slidably receiving the second proximal plunger piston of the second syringe plunger of the first body; A medical sealant applicator device, wherein the distal needle connector port of the longitudinal fluid chamber of the second body is capable of translational movement within the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body.

2. 2. The medical sealant applicator device of claim 1, wherein when a force is applied to the proximal ends of the first and second syringe barrels in a distal direction, the force overcomes a biasing force of a first biasing assembly of the first body and a second biasing assembly of the medical sealant applicator device simultaneously, causing the first and second syringe plungers to move in a proximal direction relative to the first and second syringe barrels and an elongated needle to move distally away from the base in the distal direction opposite the proximal direction.

3. 2. The medical sealant applicator device of claim 1, wherein the base of the first body includes a distal aperture, the longitudinal channel extends in the first direction from the distal aperture, and the medical sealant applicator device further comprises a needle assembly having a connector hub and an elongated needle extending from the connector hub, the connector hub being removably coupled to the distal needle connector port of the second body, and the elongated needle extending from the second body through the distal aperture of the base of the first body.

4. The second body includes: a first u-shaped connector fluidly connecting the proximal end of the longitudinal fluid chamber to the first syringe chamber; a second u-shaped connector fluidly connecting the proximal end of the longitudinal fluid chamber to the second syringe chamber; The medical sealant applicator device of claim 1 , comprising:

5. The medical sealant applicator device of claim 1 , further comprising a pair of finger retention protrusions extending laterally from the base of the first body.

6. 4. The medical sealant applicator device of claim 1, further comprising a guide assembly for setting the depth of advancement of the elongate needle.

7. 1. A medical sealant applicator device for delivery of a multi-component sealant, comprising a first body and a second body, the first body comprising: a first syringe plunger, a second syringe plunger, and a longitudinal channel interposed laterally between the first and second syringe plungers, each of the first and second syringe plungers oriented to extend in a first direction from the base, the first syringe plunger having a first free end having a first proximal plunger piston, and the second syringe plunger having a second free end having a second proximal plunger piston; and the second body comprising: a first syringe chamber, a second syringe chamber, and a longitudinal fluid chamber interposed laterally between the first syringe chamber and the second syringe chamber, the longitudinal fluid chamber having a proximal end and a distal end, the proximal end of the longitudinal fluid chamber being fluidly connected to each of the first syringe chamber and the second syringe chamber, and the distal end of the longitudinal fluid chamber having a distal needle connector port; the first syringe chamber of the second body having a first distal opening for slidably receiving the first proximal plunger piston of the first syringe plunger of the first body; the second syringe chamber of the second body having a second distal opening for slidably receiving the second proximal plunger piston of the second syringe plunger of the first body; the distal needle connector port of the longitudinal fluid chamber of the second body is capable of translation within the longitudinal channel of the first body in response to longitudinal translation of the second body relative to the first body; The medical sealant applicator device comprises: a guide assembly for establishing a path toward a target location and for maintaining said path during advancement of said needle assembly to inject a component; The medical sealant applicator device further comprises:

8. 8. The medical sealant applicator device of claim 7, wherein when a force is applied to the proximal ends of the first and second syringe barrels in a distal direction, the force overcomes a biasing force of a first biasing assembly of the first body and a second biasing assembly of the second body simultaneously, causing the first and second syringe plungers to move in a proximal direction relative to the first and second syringe barrels and an elongated needle to move distally away from the base in the distal direction opposite the proximal direction.

9. 8. The medical sealant applicator device of claim 7, wherein the base of the first body includes a distal aperture, the longitudinal channel extends in the first direction from the distal aperture, and the medical sealant applicator device further comprises a needle assembly having a connector hub and an elongated needle extending from the connector hub, the connector hub being removably coupled to the distal needle connector port of the second body, and the elongated needle extending from the second body through the distal aperture of the base of the first body.

10. The second body includes: a first u-shaped connector fluidly connecting the proximal end of the longitudinal fluid chamber to the first syringe chamber; a second u-shaped connector fluidly connecting the proximal end of the longitudinal fluid chamber to the second syringe chamber; 9. The medical sealant applicator device of claim 7 or 8, comprising:

11. 10. The medical sealant applicator device of any one of claims 7 to 9, comprising a pair of finger retention protrusions extending laterally from the base of the first body.

12. The medical sealant applicator device of claim 7 , wherein the guide assembly sets the depth of advancement of the elongate needle.

13. setting a path for a needle assembly through the pleural cavity toward a target at a known distance and maintaining said path while advancing said needle assembly; advancing the needle assembly through the pleural cavity at a first rate the known distance; applying a distal force to a proximal end of the needle assembly, the force simultaneously injecting the substance at a second rate; The method includes:

14. The method of claim 13 , wherein the step of advancing the needle assembly is simultaneous with the step of applying the force.

15. 15. The method of claim 13 or 14, wherein the first speed of the needle assembly is correlated to the second speed of injecting the substance.

16. 16. The method of claim 15, wherein a correlation of the first velocity of the needle assembly to the second velocity of injecting the substance is modifiable.

17. 17. The method of any one of claims 13 to 16, wherein a guide assembly advances the needle assembly further into the subject's lung.

18. 1. An ingredient delivery system comprising: a needle assembly having an elongated needle with proximal and distal ends spaced a distance from one another to define at least one fluid pathway therebetween, the distal end including one or more fluid outlets coupled to the at least one fluid pathway; an applicator fluidly connected to the proximal end of the needle assembly, the applicator comprising: a first body including a first biasing assembly coupled to the needle assembly, the first body biasing the needle assembly proximally relative to the applicator; A second body, a syringe chamber having a needle connector port at a proximal end fluidly connected to the needle assembly; and a syringe plunger disposed within the syringe chamber at a distal end and movable within the syringe chamber; A second body comprising: a second biasing assembly coupled between the first body and the second body, the second biasing assembly biasing the syringe plunger at the distal end of the syringe chamber; An ingredient delivery system comprising:

19. 20. The component delivery system of claim 18, wherein when a force is applied to the proximal end of the syringe chamber in a distal direction, the force overcomes the biasing forces of the first biasing assembly and the second biasing assembly simultaneously, thereby causing the syringe plunger to move in a proximal direction relative to the syringe chamber and the needle assembly to move distally away from the first body in the distal direction opposite the proximal direction.

20. 20. The component delivery system of claim 18 or 19, wherein the needle assembly further comprises a connector hub removably connected to the needle connector port, the elongated needle extending from the second body through the first body.

21. 21. The component delivery system of claim 18, further comprising a pair of finger retention protrusions extending laterally from the first body.

22. 21. A component delivery system according to any one of claims 18 to 20, comprising a guide assembly for setting the depth of advancement of the elongate needle.

23. a guide assembly, the guide assembly including a depth adjustment component, a base and an angle adjustment component; The depth adjustment component comprises: a threaded shaft comprising a shaft head having a first shaft surface and a second shaft surface opposite the first shaft surface, the first shaft surface contacting the component delivery system; a collar having internal threads that threadingly engage the threaded shaft in a locking setting and a slot that permits translation of the threaded shaft along a central axis of the guide assembly in an adjustment setting; a shaft platform contacting the second shaft surface of the shaft head; an arcuate platform coupled to the shaft platform; Equipped with The angle adjustment component includes: a first guide member having a first end connected to the base, a second end connected to the base, and a first intermediate portion between the first end and the second end, the first intermediate portion disposed a distance from the base and contacting the arcuate platform; a second guide member having a first end coupled to the base, a second end coupled to the base, and a second intermediate portion between the first end of the second guide member and the second end of the second guide member, the second intermediate portion being disposed at a distance from the base and contacting the shaft platform; 20. The ingredient delivery system of claim 18, comprising:

24. 24. The component delivery system of claim 23, wherein the threaded shaft is movable along the central axis while at the adjustment setting.

25. 24. The component delivery system of claim 23, wherein the depth adjustment component is movably coupled to the first guide member along a first axis of rotation and the second guide member is movably coupled to a second axis of rotation that is perpendicular to the first axis of rotation.

26. the threaded shaft further comprising threads defining an outer diameter; the slot defines an inner diameter greater in size than the outer diameter; 24. The ingredient delivery system of claim 23.

27. 24. The component delivery system of claim 23, wherein the elongated needle is disposed within a shaft outlet of the threaded shaft.

28. 24. The component delivery system of claim 23, wherein the first end and the second end are rotatably coupled to the base, thereby facilitating rotation of the first guide member relative to the base.

29. 24. The component delivery system of claim 23, wherein the first end of the second guide member and the second end of the second guide member are rotatably coupled to the base, thereby facilitating rotation of the second guide member relative to the base.

30. 24. The component delivery system of claim 23, wherein the first intermediate portion and the second intermediate portion are disposed between a surface of the shaft platform and a surface of the arcuate platform.

31. The base portion is a first side and a second side diametrically opposite the first side; a third side and a fourth side diametrically opposite the third side; Further equipped with the first side is coupled to the first end of the first guide member; the second side is coupled to the second end of the first guide member; the third side is coupled to the first end of the second guide member; the fourth side is coupled to the second end of the second guide member; 24. The ingredient delivery system of claim 23.

32. a needle assembly that is trajectory-set through the pleural cavity toward a target a known distance, said trajectory being maintained during advancement of said needle assembly; the needle assembly is advanced through the pleural cavity at a first rate to the known distance; a force is applied to the proximal end of the needle assembly in a distal direction, the force simultaneously injecting the substance at a second rate. Needle Assembly 16. A device comprising:

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